1. PALO ALTO, Calif., Sept. 15, 2021 /PRNewswire/ -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a commercial-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, today announced that the United States Food and Drug Administration (FDA) granted Fast Track designation for the investigation of BBP-418 as a treatment option for Limb-girdle Muscular Dystrophy Type 2i (LGMD2i). The FDA grants development programs Fast Track designation to help drive the development and expedite its review process for drugs being investigated to treat serious conditions and fill unmet medical needs. The FDA utilizes this program to provide patients access…

    PALO ALTO, Calif., Sept. 15, 2021 /PRNewswire/ -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a commercial-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, today announced that the United States Food and Drug Administration (FDA) granted Fast Track designation for the investigation of BBP-418 as a treatment option for Limb-girdle Muscular Dystrophy Type 2i (LGMD2i). The FDA grants development programs Fast Track designation to help drive the development and expedite its review process for drugs being investigated to treat serious conditions and fill unmet medical needs. The FDA utilizes this program to provide patients access to important new drugs as early as possible. This is the fifth Fast Track designation for an investigational therapy that BridgeBio has received this year.

    BridgeBio's LGMD2i investigational therapy is one of the Company's 14 programs that are in the clinic or commercial setting for patients living with genetic diseases and genetically-driven cancers.

    BridgeBio's first wave of programs are the now-approved drugs for Molybdenum Cofactor Deficiency (MoCD) Type A and previously-treated locally advanced or metastatic cholangiocarcinoma (CCA) harboring an FGFR2 fusion or rearrangement. The second wave of programs includes the Company's four major near-term catalysts for its product candidates for the treatment of transthyretin (TTR) amyloidosis (ATTR), achondroplasia, congenital adrenal hyperplasia (CAH) and autosomal dominant hypocalcemia type 1 (ADH1).

    LGMD2i represents one of the leading programs in BridgeBio's ongoing third wave in development, which includes a variety of programs in the cancer and mendelian space already in the clinic.

    With approximately 7,000 patients with potentially treatable mutations, LGMD2i is an inherited recessive muscular dystrophy caused by mutation of fukutin-related protein (FKRP). FKRP is a critical enzyme that adds a specific sugar molecule to a muscle cell structural protein called alpha-dystroglycan (αDG). Due to defective FKRP enzyme function, muscle cells of patients affected by LGMD2i lack a robust cushioning system that is provided by fully glycosylated αDG proteins. Pediatric and adult patients with LGMD2i most commonly present with upper and lower extremity ("limb") and thoracic ("girdle") dysfunction ("limb-girdle" pattern of weakness), and without treatment often develop additional severe clinical manifestations, including loss of independent ambulation, severe breathing issues which can require mechanical ventilation, cardiomyopathy and premature death.

    "As of now, there are no approved treatment options for people born with Limb-girdle Muscular Dystrophy Type 2i. People living with this disease can lose their ability to perform routine daily activities, and ultimately may lose the ability to walk, need ventilatory support or face the risk of heart failure," said Douglas Sproule, M.D., M.Sc., chief medical officer of ML Bio Solutions, Inc., the BridgeBio company developing BBP-418. "We are grateful the FDA has granted our program Fast Track designation based on the potential of our investigational therapy to treat this very serious condition. We are hopeful the designation will allow us to address this unmet medical need by allowing us to potentially deliver our medicine to patients more quickly."

    BBP-418 is being investigated as a treatment for LGMD2i. The investigational therapy is designed to overcome the enzymatic limitation of the defective FKRP enzyme by supplementing endogenous sugar molecules to glycosylate αDG and to improve muscle cell integrities, resulting in improved muscle strength and function for patients. Clinical trials to verify the safety and efficacy of BBP-418 are ongoing.

    BBP-418 has received Orphan Drug Designation for the treatment of LGMD2i from the FDA and for LGMD from the European Medicines Agency. BridgeBio is currently advancing its Phase 2 clinical trial in subjects with a genetically confirmed diagnosis of LGMD2i. If the development program is successful, BBP-418 could be the first approved therapy for the treatment of patients with LGMD2i.

    About Limb-girdle Muscular Dystrophy Type 2i

    LGMD2i is a monogenic autosomal recessive disease caused by partial loss of function mutations in the FKRP gene, and these FKRP mutations impair glycosylation of α-DG, a protein associated with stabilizing muscle cells.  LGMD2i is a disease that has pediatric symptomatic onset with most individuals developing manifestations of disease between 5 and 18 years of age. Clinical manifestations typically present as a skeletal myopathy affecting the lower and then upper limbs, which is commonly later accompanied by respiratory muscle and cardiac muscle involvement.  Patients who harbor a homozygous genotype typically develop disease manifestations during late childhood with progression to loss of independent ambulation (25%), assisted ventilation (5%), and cardiomyopathy (10%) in adulthood. Cardiomyopathy is progressive, with an annual loss of 0.4% of left ventricular ejection fraction (LVEF). Patients with heterozygous genotypes have an earlier childhood onset with a more severe clinical course, rapid loss of mobility by 20 years of age, more frequent cardiac involvement (25%), and eventual respiratory failure by 30 years of age in nearly all cases.

    About BridgeBio Pharma, Inc.

    BridgeBio Pharma Inc. (BridgeBio) is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio's pipeline of over 30 development programs ranges from early science to advanced clinical trials, and its commercial organization is focused on delivering the company's first two approved therapies. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers, and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com and follow us on LinkedIn and Twitter.

    BridgeBio Pharma, Inc. Forward-Looking Statements

    This press release contains forward-looking statements. Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), which are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions.  We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions.  These forward-looking statements, including statements relating to the timing and success of ML Bio Solutions' clinical trials of BBP-418 for the treatment of LGMD2i, expectations, plans and prospects regarding ML Bio Solutions' regulatory approval process for BBP-418, the ability of BBP-418 to treat LGMD2i in humans, the potential for BBP-418 to be the first approved therapy for the treatment of LGMD2i and the timing and success of BridgeBio's clinical trials and development pipeline, reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved.  Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, ML Bio Solutions' ability to continue and complete its clinical trials of BBP-418 for the treatment of LDMD2i, past data from preclinical studies not being indicative of future data from clinical trials, ML Bio Solutions' ability to advance BBP-418 in clinical development according to its plans, the ability of BBP-418 to be the first approved therapy for the treatment of patients with LGMD2i, BridgeBio's ability to advance its clinical trials and development pipeline, the success of BridgeBio's approved drugs, as well as those risks set forth in the Risk Factors section of BridgeBio Pharma's Annual Report on Form 10-K for the year ended December 31, 2020, and BridgeBio Pharma's other SEC filings. Moreover, ML BioSolutions operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

    BridgeBio Media Contact: 

    Grace Rauh

    grace.rauh@bridgebio.com

    (917) 232-5478

    BridgeBio Investor Contact:

    Katherine Yau

    katherine.yau@bridgebio.com

    (516) 554-5989

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  2. PALO ALTO, Calif., Sept. 8, 2021 /PRNewswire/ -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a commercial-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, today announced that on September 2, 2021, the compensation committee of BridgeBio's board of directors granted 29 new employees restricted stock units for an aggregate of 61,210 shares of the Company's common stock. All of the above-described awards were made under BridgeBio's 2019 Inducement Equity Plan (the Plan).

    The above-described awards were each granted as an inducement material to the employees entering into employment with the Company in accordance with Nasdaq Listing…

    PALO ALTO, Calif., Sept. 8, 2021 /PRNewswire/ -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a commercial-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, today announced that on September 2, 2021, the compensation committee of BridgeBio's board of directors granted 29 new employees restricted stock units for an aggregate of 61,210 shares of the Company's common stock. All of the above-described awards were made under BridgeBio's 2019 Inducement Equity Plan (the Plan).

    The above-described awards were each granted as an inducement material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4), and were granted pursuant to the terms of the Plan. The Plan was adopted by BridgeBio's board of directors in November 2019.

    About BridgeBio

    BridgeBio is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio's pipeline of over 30 development programs ranges from early science to advanced clinical trials and its commercial organization is focused on delivering the Company's first approved therapy. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com.

    Media Contact:

    Grace Rauh

    Grace.rauh@bridgebio.com

    (917) 232-5478

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  3. LianBio, a biotechnology company dedicated to bringing paradigm-shifting medicines to patients in China and other major Asian markets, and BridgeBio Pharma, Inc. (NASDAQ:BBIO) today announced the first patient has been treated in a Phase 2a clinical trial of infigratinib in patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with fibroblast growth factor receptor-2 (FGFR2) gene amplification and other advanced solid tumors with FGFR genomic alterations.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210825005264/en/

    "Infigratinib is a potent and selective FGFR inhibitor that has demonstrated compelling clinical activity across multiple…

    LianBio, a biotechnology company dedicated to bringing paradigm-shifting medicines to patients in China and other major Asian markets, and BridgeBio Pharma, Inc. (NASDAQ:BBIO) today announced the first patient has been treated in a Phase 2a clinical trial of infigratinib in patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with fibroblast growth factor receptor-2 (FGFR2) gene amplification and other advanced solid tumors with FGFR genomic alterations.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210825005264/en/

    "Infigratinib is a potent and selective FGFR inhibitor that has demonstrated compelling clinical activity across multiple tumor types with FGFR alterations," said Yizhe Wang, Ph.D., chief executive officer of LianBio. "Given the disproportionately high prevalence rate of gastric cancer in China, LianBio is pursuing a region-specific development strategy focused on this area of great unmet need. This study marks LianBio's first trial initiation and demonstrates our continued progress in delivering potentially transformational medicines to patients in Asia."

    TRUSELTIQ™ (infigratinib) is an oral selective inhibitor of FGFR1-3 that is approved in the United States for the treatment of patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or other rearrangement as detected by an FDA-approved test. It is also being further evaluated in clinical trials based on demonstration of clinical activity in patients with advanced urothelial carcinoma with FGFR3 genomic alterations. LianBio in-licensed rights from BridgeBio for infigratinib for development and commercialization in Mainland China, Hong Kong and Macau.

    The Phase 2a trial is a multicenter, open-label, single-arm study in China designed to evaluate the safety and efficacy of infigratinib in patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 gene amplification and other advanced solid tumors with FGFR alterations. The primary endpoint is objective response rate (ORR). Secondary endpoints include duration of response, safety, disease control rate, progression-free survival and overall survival.

    Preclinical data have demonstrated the potential infigratinib may have for patients with gastric cancer. These results, published in Cancer Discovery, demonstrated tumor regression in multiple in vivo FGFR2 amplified gastric models.1

    "We believe that infigratinib could have a meaningful impact for people living with gastric cancer as well as many other cancers with FGFR alterations, and are pleased LianBio is initiating this clinical trial in China where more therapeutic options are needed to match the growing diagnosis rate," said BridgeBio founder and chief executive officer Neil Kumar, Ph.D. "On the heels of TRUSELTIQ recently obtaining accelerated approval in the United States, we are hopeful that this trial will yield pivotal results in another subset of cancer patients as we continue to build our portfolio of oncology indications with the aim of reaching as many people in need as possible."

    About TRUSELTIQ™ (infigratinib)

    TRUSELTIQ (infigratinib) is an orally administered, ATP-competitive, tyrosine kinase inhibitor of fibroblast growth factor receptor (FGFR) that received accelerated approval from the FDA in the United States for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. TRUSELTIQ targets the FGFR protein, blocking downstream activity. In clinical studies, TRUSELTIQ demonstrated a clinically meaningful rate of tumor shrinkage (overall response rate) and duration of response. TRUSELTIQ is not FDA-approved for any other indication in the United States and is not approved for use by any other health authority, including any Chinese or other Asian health authority. It is currently being evaluated in clinical studies for first-line cholangiocarcinoma, urothelial carcinoma (bladder cancer), locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma, and other advanced solid tumors with FGFR genomic alterations.

    About BridgeBio Pharma, Inc.

    BridgeBio is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio's pipeline of over 30 development programs ranges from early science to advanced clinical trials and its commercial organization is focused on delivering the company's first two approved therapies. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com.

    About LianBio

    LianBio's mission is to catalyze the development and accelerate availability of paradigm-shifting medicines to patients in China and other major Asian markets, through partnerships that provide access to innovative therapeutic discoveries with a strong scientific basis and compelling clinical data. LianBio collaborates with world-class partners across a diverse array of therapeutic and geographic areas to build out a broad and clinically validated pipeline with the potential to impact patients with unmet medical needs. For more information, please visit www.lianbio.com.

    About the LianBio and BridgeBio Pharma, Inc. Strategic Alliance

    In August 2020, LianBio entered into a strategic alliance with BridgeBio, a commercial-stage biopharmaceutical company focused on genetic diseases and cancers with clear genetic drivers, to develop and commercialize BridgeBio's programs in China and other major Asian markets. This strategic relationship initially focuses on two of BridgeBio's targeted oncology drug candidates: FGFR inhibitor infigratinib, for the treatment of FGFR-driven tumors, and SHP2 inhibitor BBP-398, in development for tumors driven by MAPK pathway mutations. The agreement also provides LianBio with preferential future access in China and certain other major Asian markets to more than 20 drug development candidates currently owned or controlled by BridgeBio. This collaboration is designed to advance and accelerate BridgeBio's programs in China and other major Asian markets, allowing BridgeBio and LianBio to potentially bring innovation to large numbers of patients with high unmet need.

    BridgeBio Pharma, Inc. Forward-Looking Statements

    This press release contains forward-looking statements. Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act, and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements relating to: the timing and success of the Phase 2a clinical trial of infigratinib in patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with fibroblast growth factor receptor-2 (FGFR2) gene amplification, and other advanced solid tumors with FGFR genomic alterations; the planned approval of infigratinib by foreign regulatory authorities in China and the necessary clinical trial results, and timing and completion of regulatory submissions related thereto; and the competitive environment and clinical and therapeutic potential of infigratinib; reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation: the safety, tolerability and efficacy profile of infigratinib observed to date may change adversely in ex-U.S. clinical trials, ongoing analyses of trial data or subsequent to commercialization; foreign regulatory agencies may not agree with our regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; the continuing success of the BridgeBio and LianBio strategic alliance; and potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; as well as those set forth in the Risk Factors section of BridgeBio Pharma, Inc.'s most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent SEC filings, which are available on the SEC's website at www.sec.gov. Except as required by law, each of BridgeBio and QED disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. Moreover, BridgeBio and QED operate in a very competitive environment in which new risks emerge from time to time. These forward-looking statements are based on each of BridgeBio's and QED's current expectations, and speak only as of the date hereof.

    1 Guagnano, V., Kauffman, A., Wörle, S., et al. "FGFR Genetic Alterations Predict for Sensitivity to NVP-BGJ398, a Selective Pan-FGFR Inhibitor." Cancer Discovery 2 (2012): 1118-1133.

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  4. PALO ALTO, Calif., Aug. 18, 2021 /PRNewswire/ -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a commercial-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, today announced that it has added three new independent directors to its board: Fred Hassan, a pharmaceutical and financial industry giant who is the former CEO of Schering-Plough and former chairman of Bausch & Lomb; Andrea Ellis, a consumer technology innovator and the chief financial officer of Lime; and Douglas Dachille, an investment management veteran and the former chief investment officer of American International Group, Inc. (AIG).

    PALO ALTO, Calif., Aug. 18, 2021 /PRNewswire/ -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a commercial-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, today announced that it has added three new independent directors to its board: Fred Hassan, a pharmaceutical and financial industry giant who is the former CEO of Schering-Plough and former chairman of Bausch & Lomb; Andrea Ellis, a consumer technology innovator and the chief financial officer of Lime; and Douglas Dachille, an investment management veteran and the former chief investment officer of American International Group, Inc. (AIG).

    "We are privileged to have the opportunity to work with and learn from Fred, Andrea and Doug, and are grateful they are committed to helping us grow and advance our pipeline of potential therapies to treat patients with genetic diseases," said BridgeBio founder and CEO Neil Kumar, Ph.D. "We are confident that the collective guidance these new directors offer will strengthen our ability to serve patients around the world."

    Fred Hassan

    Mr. Hassan brings extensive experience leading and scaling global pharmaceutical companies and advising major corporates as a director, which will benefit BridgeBio as it expands its commercial infrastructure and broadens its reach to patients.

    Mr. Hassan works as director at Warburg Pincus LLC, a global private equity institution. Previously, Mr. Hassan was the chairman and chief executive officer of Schering-Plough and chairman and chief executive officer of Pharmacia Corporation, a company formed through the merger of Monsanto Company and Pharmacia & Upjohn, Inc. Mr. Hassan is a director at Prometheus Biosciences, and Precigen, both public biopharma companies using advanced technologies.

    His previous directorships include Time Warner Inc. until its acquisition by AT&T Inc. in 2018, and Avon Products, where he served as chairman of the board, and Bausch & Lomb, where he also served as chairman. He has also served as a director at Amgen. Mr. Hassan earned a bachelor's degree from Imperial College of Science and Technology, University of London and a master's degree in business administration from Harvard Business School.

    "BridgeBio is creating something unique within the industry and I have been deeply impressed by its ability to accelerate the development of therapies for patients in need," Mr. Hassan said. "I look forward to drawing on my experience as a leader of global pharmaceutical businesses to help BridgeBio grow into a world-class company with the ability to help millions of patients around the world who are suffering from genetic diseases and genetically-driven cancers."

    Andrea Ellis

    As a financial expert in the technology and food sector, Mrs. Ellis will bring a fresh outsider perspective and industry diversity to the BridgeBio board.

    Mrs. Ellis is the chief financial officer of Lime, an innovative transportation technology company that offers access to shared electric scooters, bikes and mopeds that is built on sustainability. Prior to joining Lime, Mrs. Ellis held various roles in finance, operations, and product management at Restaurant Brands International for many leading food chains. She previously spent six years at Goldman Sachs in investment banking and trading. Mrs. Ellis earned her bachelor's degree from the University of Pennsylvania and a master's degree in business administration from Harvard Business School.

    "I'm thrilled to have the chance to help BridgeBio revolutionize the biotech and pharmaceutical industry with its groundbreaking approach to drug development. I am ready and eager to bring my experience in tech and finance to the board and aid the company in its mission to develop and deliver transformative medicines for patients suffering from genetic diseases," Mrs. Ellis said.

    Douglas Dachille

    Mr. Dachille is an investment veteran who brings nearly 30 years of deep financial and strategic expertise to the board. He previously served as a board observer for the Company.

    Mr. Dachille is AIG's former chief investment officer, where he had responsibility for overseeing the investment portfolios of AIG's insurance companies and the investments of third-party clients managed by First Principles Capital Management, LLC, an AIG subsidiary. He joined the company when AIG acquired First Principles Capital Management, LLC, an institutional fixed income asset manager, which he co-founded and served as chief executive officer. Mr. Dachille previously served as president and chief operating officer of Zurich Capital Markets and began his investment career at JPMorgan Chase & Company, where he served as global head of proprietary trading as well as co-treasurer. He earned his bachelor's degree in a special joint program through Union University and Albany Medical College, and later was a Pew Scholar at the University of Chicago, where he earned a master's degree in business administration.

    "As a former board observer, I'm excited to make the leap and become a director at BridgeBio, a company I firmly believe is transforming the biotech industry with its innovative hub-and-spoke business model and deep and diversified drug pipeline," Mr. Dachille said. "I look forward to helping BridgeBio grow into a global commercial organization that is able to reach and help patients in need around the world."

    About BridgeBio Pharma, Inc.

    BridgeBio Pharma (BridgeBio) is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio's pipeline of over 30 development programs ranges from early science to advanced clinical trials and its commercial organization is focused on delivering the company's two approved therapies. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com.

    BridgeBio Contact:

    Grace Rauh

    BridgeBio Pharma, Inc.

    Grace.rauh@bridgebio.com

    (917) 232-5478

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  5. PALO ALTO, Calif., Aug. 5, 2021 /PRNewswire/ -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) (BridgeBio or the Company), a commercial-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, today reported its financial results for the second quarter ended June 30, 2021 and provided an update on the Company's operations.

    "We measure success by the number of meaningful medicines we are able to develop and deliver to patients. By that metric, our most significant accomplishment of the quarter was the approval of TRUSELTIQ™ (infigratinib) for patients with cholangiocarcinoma - our second FDA approval as a company and our first for a cancer treatment. All drug approvals are a team effort that extends far beyond BridgeBio. We thank the patient community, physicians, scientists and advocates for their commitment and drive. They made this approval possible," said BridgeBio founder and CEO Neil Kumar, Ph.D.

    Major milestones anticipated in the next 12 months for BridgeBio's four core value drivers:

    • Acoramidis (AG10) – Transthyretin (TTR) stabilizer for transthyretin amyloid cardiomyopathy (ATTR-CM): Topline results from Part A of the ATTRibute-CM trial are expected in late 2021 and from Part B in 2023. The primary endpoint at Part A is the change from baseline in a 6-minute walk distance (6MWD) in trial participants receiving acoramidis or placebo after 12 months. In a previous Phase 3 study in ATTR-CM patients, participants receiving the current standard of care treatment demonstrated a decline in 6MWD of approximately 25 meters (m) from an average baseline of 351m at 12 months.1 From a comparable average 6MWD baseline in the ATTRibute-CM study, the Company is seeking to more potently halt the observed decline in acoramidis-treated participants. As a reminder, healthy elderly adults typically decline only 7m in 12 months.2 If the change from baseline in 6MWD in Part A is highly statistically significant (p < 0.01), BridgeBio expects to submit an application for regulatory approval of acoramidis in 2022 to the FDA.
    • Encaleret – Calcium-sensing receptor (CaSR) inhibitor for ADH1: Received Fast Track designation from the FDAEarly results from an ongoing Phase 2 proof-of-concept study shared at the Endocrine Society's 2021 Annual Meeting (ENDO) in March 2021 showed normalization of blood calcium and urine calcium in 6 of 6 (100%) ADH1 participants. Additional data from the ongoing study are expected in the second half of 2021. If the development program is successful, encaleret could be the first approved therapy for ADH1, a condition caused by gain of function variants in the CaSR gene estimated to be carried by 12,000 individuals in the United States alone.
    • Low-dose infigratinib – FGFR1-3 inhibitor for achondroplasia: Initial data from the ongoing Phase 2 dose ranging study are expected in the first half of 2022. Achondroplasia is the most common form of genetic short stature and one of the most common genetic diseases, with a prevalence of greater than 55,000 cases in the United States and European Union. Low-dose infigratinib is the only known product candidate in clinical development for achondroplasia that is designed to target the disease at its genetic source and the only orally administered product candidate in clinical-stage development.
    • BBP-631 – AAV5 gene therapy candidate for congenital adrenal hyperplasia (CAH): Received Fast Track designation from the FDA in May 2021. Investigational New Drug (IND) application cleared by the FDA and site activation for initiation of a first-in-human Phase 1/2 study is ongoing, with initial data anticipated in mid-2022. CAH is one of the most prevalent genetic diseases potentially addressable with AAV gene therapy, with more than 75,000 cases estimated in the United States and European Union. The disease is caused by deleterious mutations in the gene encoding an enzyme called 21-hydroxylase, leading to lack of endogenous cortisol production. BridgeBio's AAV5 gene therapy candidate is designed to provide a functional copy of the 21-hydroxylase-encoding gene (CYP21A2) and potentially address many aspects of the disease course.

    Recent pipeline progress and corporate updates:

    • FDA approval received for TRUSELTIQ™ (infigratinib) under the accelerated approval program for the treatment of patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma (CCA) with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement as detected by an FDA-approved test. TRUSELTIQ is an orally administered, ATP-competitive, tyrosine kinase inhibitor of FGFR. In the pivotal trial of patients with advanced, unresectable CCA, an aggressive malignancy with poor prognosis, TRUSELTIQ led to cases of tumor shrinkage. BridgeBio is eligible to receive upfront, regulatory and commercial milestone payments totaling up to approximately $2.45 billion USD through its strategic collaboration with Helsinn Group to co-develop and commercialize infigratinib in certain oncology indications.
    • Fast Track designation received from the FDA for BBP-812, BridgeBio's AAV9 gene therapy candidate for Canavan disease. IND cleared by the FDA and site activation for initiation of a first-in-human Phase 1/2 study is ongoing. Canavan disease is an extremely rare genetic condition starting in infancy with an incidence of approximately one in 100,000 births worldwide.
    • Fast Track designation received from the FDA for infigratinib, an FGFR inhibitor, for the treatment of urothelial carcinoma (urinary tract and bladder cancer).
    • New Drug Application (NDA) acceptance from the Israeli Ministry of Health for NULIBRY™ (fosdenopterin) for injection to treat patients with molybdenum cofactor deficiency (MoCD) Type A. The FDA approved NULIBRY as the first therapy to reduce the risk of mortality in patients with MoCD Type A in February 2021. MoCD Type A is an ultra-rare, life-threatening genetic disorder that progresses rapidly, results in severe and largely irreversible neurological injury, and has a high infant mortality rate.
    • First-in-human Phase 1 trial of BBP-711, a glycolate oxidase (GO) inhibitor to treat patients with hyperoxaluria, initiated in May 2021.
    • Research collaborations initiated with MUSC Foundation for Research Development, Stanford University and the University of Pittsburgh to identify and advance therapies for genetic diseases and cancers for a total of 23 partnerships among BridgeBio and leading academic and research institutions to date.
    • Non-exclusive, co-funded clinical collaboration initiated with Bristol Myers Squibb to study BBP-398, a potentially best-in-class SHP2 inhibitor, in combination with OPDIVO® (nivolumab) in patients with advanced solid tumors with KRAS mutations.
    • BridgeBio Pharma R&D Day: BridgeBio will hold a virtual R&D Day on Tuesday, October 12, 2021, from 8:30 am ET11:30 am ET. The event will be webcast and registration information can be found here.

    Second Quarter 2021 Financial Results:

    Cash, Cash Equivalents and Marketable Securities

    Cash, cash equivalents and marketable securities, excluding restricted cash, totaled $898.4 million as of June 30, 2021, compared to $607.1 million as of December 31, 2020. The net increase in balance of $291.3 million is attributed to $731.4 million in net proceeds received from the issuance of our 2.25% Convertible Senior Notes due 2029 (the 2029 Notes) in January 2021 and $30.2 million in upfront payment and reimbursements received in connection with our License and Collaboration Agreement with Helsinn Healthcare S.A. and Helsinn Therapeutics (U.S.), Inc. (collectively, Helsinn) , which became effective in April 2021, and $25.0 million in net proceeds from our Amended Loan and Security Agreement with Hercules Capital, Inc. in April 2021 (the Amended Hercules Term Loan). The cash receipts were partially offset by a $61.3 million payment related to capped call options and a $50.0 million payment to repurchase shares of BridgeBio common stock, both in relation to the issuance of our 2029 Notes. In connection with our acquisition of Eidos Therapeutics, Inc. (Eidos) in January 2021, we paid $63.6 million in direct transaction costs and $21.3 million to Eidos stockholders who elected cash settlement. The remaining change of $299.1 million primarily related to payments of interest and operating costs and expenses.

    Cash, cash equivalents and marketable securities, excluding restricted cash, decreased by $102.9 million compared to our balance as of March 31, 2021, which was $1,001.3 million. The decrease in cash is mainly due to cash used primarily related to our operating costs and expenses and partially offset by the payments received from Helsinn and proceeds from the Amended Hercules Term Loan as also discussed above.

    Revenues

    Total revenues for the three and six months ended June 30, 2021 were $54.0 million and $54.5 million, respectively. Our revenues mainly include upfront and milestone payments arising from the License and Collaboration Agreement with Helsinn and the License Agreement between our affiliate Navire Pharma, Inc. and LianBio.

    Operating Costs and Expenses

    Operating costs and expenses for the three and six months ended June 30, 2021 were $148.0 million and $316.0 million, respectively, as compared to $124.6 million and $227.1 million for the same periods in the prior year. The increases in operating costs and expenses of $23.4 million and $88.9 million, respectively, during the periods were attributable to the increase in personnel costs resulting from an increase in the number of employees to support the progression in our research and development programs, including our increasing research pipelines, as well as an increase in stock-based compensation related to the achievement of various performance-based milestone compensation arrangements tied to regulatory and development milestones. Stock-based compensation for the three and six months ended June 30, 2021 was $32.0 million and $66.9 million, respectively, as compared to $18.4 million and $28.6 million for the same periods in the prior year. Amounts for the three and six months ended June 30, 2021 reflect the reduction in operating costs and expenses arising from cost sharing recognized under our License and Collaboration Agreement with Helsinn.

    Our research and development expenses have not been significantly impacted by the global COVID-19 pandemic for the periods presented. While we experienced some delays in certain of our clinical enrollment and trial commencement activities, we continue to adapt in this unprecedented time to enable alternative site, telehealth and home visits, at-home drug delivery, as well as mitigation strategies with our contract manufacturing organizations. The longer-term impact, if any, of COVID-19 on our operating costs and expenses is currently unknown.

    BRIDGEBIO PHARMA, INC.

    Condensed Consolidated Statements of Operations

    (in thousands, except shares and per share amounts)







    Three Months Ended June 30,



    Six Months Ended June 30,





    2021



    2020



    2021



    2020





    (Unaudited)



    (Unaudited)

    Revenue



    $ 54,024



    $ —



    $ 54,486



    $ —

    Operating costs and expenses:

















    Research and development



    102,069



    86,598



    224,628



    154,823

    Selling, general and

       administrative



    45,970



    37,969



    91,377



    72,231

    Total operating costs and 

      expenses



    148,039



    124,567



    316,005



    227,054

    Loss from operations



    (94,015)



    (124,567)



    (261,519)



    (227,054)

    Other income (expense), net:

















    Interest income



    323



    934



    717



    2,875

    Interest expense



    (10,839)



    (10,754)



    (20,577)



    (14,764)

    Other income



    2,457



    (1,827)



    8,223



    (1,353)

    Total other income

      (expense), net



    (8,059)



    (11,647)



    (11,637)



    (13,242)

    Net loss



    (102,074)



    (136,214)



    (273,156)



    (240,296)

    Net loss attributable to 

      redeemable convertible 

      noncontrolling interests and 

      noncontrolling interests



    5,726



    15,180



    13,729



    27,412

    Net loss attributable to common

      stockholders of BridgeBio



    $ (96,348)



    $ (121,034)



    $ (259,427)



    $ (212,884)

    Net loss per share, basic and diluted



    $(0.66)



    $(1.03)



    $(1.82)



    $(1.81)

    Weighted-average shares used in

      computing net loss per share, basic

      and diluted



    146,754,299



    117,012,062



    142,713,463



    117,407,750

     

    BRIDGEBIO PHARMA, INC.

    Condensed Consolidated Balance Sheets

    (In thousands)







    June 30,



    December 31,





    2021



    2020

    Assets



    (Unaudited)



    (1)

    Cash and cash equivalents and marketable securities (2)



    $ 898,351



    $ 607,093

    Receivable from licensing and collaboration agreements



    35,363



    Receivable from a related party



    8,962



    Prepaid expenses and other current assets



    27,883



    35,731

    Property and equipment, net



    26,272



    20,325

    Operating lease right-of-use assets



    15,964



    16,508

    Investment in equity securities



    18,894



    Other assets



    49,797



    23,931

    Total assets



    $ 1,081,486



    $ 703,588

    Liabilities, Redeemable Convertible

     Noncontrolling Interests and

     Stockholders' Equity (Deficit)









    Accounts payable



    $22,329



    $ 8,945

    Accrued liabilities



    105,040



    75,900

    LEO call option liability





    5,550

    Operating lease liabilities



    22,562



    18,472

    Term loans, current portion





    1,458

    Term loans, net of current portion



    102,611



    92,421

    2029 Notes



    732,202



     [ ]

    2027 Notes



    539,102



    383,436

    Other liabilities



    13,265



    9,520

    Redeemable convertible noncontrolling interests



    1,865



    1,630

    Total BridgeBio stockholders' equity (deficit)



    (464,294)



    57,906

    Noncontrolling interests



    6,804



    48,350

    Total liabilities, redeemable convertible

    noncontrolling interests and stockholders'

    equity (deficit)



    $ 1,081,486



    $ 703,588

     

    (1)

    The condensed consolidated financial statements as of and for the year ended December 31, 2020 are derived from the audited consolidated financial statements as of that date.

    (2)

    June 30, 2021 amount includes long-term marketable securities of $60.7 million.

     

    About BridgeBio Pharma, Inc.

    BridgeBio Pharma (BridgeBio) is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio's pipeline of over 30 development programs ranges from early science to advanced clinical trials and its commercial organization is focused on delivering the company's two approved therapies. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com.

    BridgeBio Pharma, Inc. Forward-Looking Statements

    This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements, including statements relating to the clinical and therapeutic potential of our programs and product candidates, the availability and success of topline results from Part A and Part B of our ATTRibute-CM trial of acoramidis, our plans to submit an application for regulatory approval of acoramidis, the availability of additional data from our ongoing study of encaleret for ADH1, the availability of initial data from our ongoing Phase 2 study of infigratinib for achondroplasia and our ongoing Phase 1/2 study of BBP-631 for CAH, our eligibility to receive future milestone payments under our strategic collaboration with the Helsinn Group and the timing of these events, as well as our anticipated cash runway, reflect our current views about our plans, intentions, expectations and strategies, which are based on the information currently available to us and on assumptions we have made.

    Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our Annual Report on Form 10-K for the year ended December 31, 2020, and our other filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

    1 Maurer, M., Schwartz, J., Gundapaneni, B., et al. "Tafamidis treatment for patients with transthyretin Amyloid cardiomyopathy". New England Journal of Medicine 379.11 (2018): 1007–16.

    2Enright, M., Duanel, S. "Reference equations for the six-minute walk in healthy adults". American Journal of Respiratory and Critical Care Medicine 158.5 (1998): 1384–7. 

    Media Contact:

    Grace Rauh

    grace.rauh@bridgebio.com

    917-232-5478

    Investor Contact:

    Katherine Yau

    katherine.yau@bridgebio.com 

    516-554-5989

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  6. PALO ALTO, Calif., Aug. 4, 2021 /PRNewswire/ -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a commercial-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, today announced that on August 3, 2021, the compensation committee of BridgeBio's board of directors granted 17 new employees restricted stock units for an aggregate of 21,414 shares of the Company's common stock. All of the above-described awards were made under BridgeBio's 2019 Inducement Equity Plan (the Plan).

    The above-described awards were each granted as an inducement material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4), and were granted pursuant to the terms of the Plan. The Plan was adopted by BridgeBio's board of directors in November 2019.

    About BridgeBio

    BridgeBio is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio's pipeline of over 30 development programs ranges from early science to advanced clinical trials and its commercial organization is focused on delivering the Company's first approved therapy. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com.

    Media Contact:

    Grace Rauh

    Grace.rauh@bridgebio.com

    (917) 232-5478

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/bridgebio-pharma-reports-inducement-grants-under-nasdaq-listing-rule-5635c4-301348831.html

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  7. PALO ALTO, Calif., July 27, 2021 /PRNewswire/ -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) (BridgeBio), a commercial-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, today announced a non-exclusive, co-funded clinical collaboration with Bristol Myers Squibb to evaluate the combination of BBP-398, a potentially best-in-class SHP2 inhibitor, with OPDIVO® (nivolumab) in patients with advanced solid tumors with KRAS mutations with the hope of providing an effective new treatment option for patients with difficult-to-treat cancers. 

    The collaboration will also include the initiation of a Phase 1/2 study to evaluate the safety and preliminary efficacy of BBP-398 in combination with both OPDIVO as doublet therapy, and OPDIVO plus a KRASG12C inhibitor as triplet therapy in non-small cell lung cancer (NSCLC) with KRAS mutations, as first- and second-line treatment options. Under the terms of the non-exclusive collaboration, BridgeBio will sponsor the study and Bristol Myers Squibb will provide nivolumab. Both BridgeBio and Bristol Myers Squibb will share the cost of clinical development activities for the combination trial.

    SHP2 is a protein-tyrosine phosphatase that links growth factor, cytokine and integrin signaling with the downstream RAS/ERK MAPK pathway to regulate cellular proliferation and survival. Overactivity of the SHP2 pathway, often driven by distinct genetic mutations, is a critical contributor to many forms of cancer, and is a mechanism of resistance to several targeted therapies.

    "Cancers that are driven by hyperactive MAPK signaling, including certain RAS mutations such as KRASG12C, may be sensitive to SHP2 inhibition," said Frank McCormick, Ph.D., chairman of oncology at BridgeBio.  "With this collaboration, we hope to better elucidate our SHP2 inhibitor's ability to enhance immuno-oncology and other targeted therapies to potentially provide options for patients with difficult-to-treat cancers as quickly and safely as possible."

    KRAS mutations occur in approximately 27% of NSCLC cases and approximately 17% of malignant solid tumors. Combination of anti-PD-1 treatment with BBP-398, and other targeted therapies, could be promising for patients with KRAS mutations.

    "A priority of ours is to develop innovative medicines that target tumor intrinsic mechanisms including the MAPK pathway," said Emma Lees, senior vice president, oncology research at Bristol Myers Squibb. "We look forward to beginning the clinical exploration of the mechanistic rationale and therapeutic benefit from combining robust MAPK pathway inhibition and PD-1 blockade in KRAS mutant NSCLC."

    "We are pleased to collaborate with Bristol Myers Squibb and advance BridgeBio's larger strategy to fully interrogate BBP-398, a potentially best-in-class SHP2 inhibitor, as an ideal combination agent for certain cancer patients given its profile and potential for once daily dosing," said Eli Wallace, Ph.D., chief scientific officer of oncology at BridgeBio.  "By partnering with one of the strongest oncology players in the industry, we hope to provide a new therapeutic approach to cancer patients in need."

    BridgeBio is currently advancing its Phase 1 clinical trial in patients with solid tumors driven by mutations in the MAPK signaling pathway, including RAS and receptor tyrosine kinase genes.

    OPDIVO® is a trademark of Bristol-Myers Squibb Company. 

    About BBP-398

    BBP-398 was developed through a collaboration with The University of Texas MD Anderson Cancer Center's Therapeutics Discovery division. BridgeBio previously entered into a strategic collaboration with LianBio for clinical development and commercialization of BBP-398 in combination with various agents in solid tumors such as NSCLC, colorectal and pancreatic cancer, in mainland China and other major Asian markets.

    About BridgeBio Pharma, Inc.

    BridgeBio Pharma (BridgeBio) is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio's pipeline of over 30 development programs ranges from early science to advanced clinical trials and its commercial organization is focused on delivering the company's two approved therapies. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com.

    BridgeBio Pharma, Inc. Forward-Looking Statements

    This press release contains forward-looking statements. Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), which are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions.  We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions.  These forward-looking statements, including statements relating to expectations, plans, and prospects regarding the success of our non-exclusive, co-funded clinical collaboration with Bristol Myers Squibb, the timing and success of a Phase 1/2 study to evaluate the safety and preliminary efficacy of BBP-398 in combination with both OPDIVO as doublet therapy, and OPDIVO plus a KRASG12C inhibitor as triplet therapy in non-small cell lung cancer with KRAS mutations, as first- and second-line treatment options, the ability of our SHP2 inhibitor's ability to enhance immuno-oncology and other targeted therapies to potentially provide options for patients with difficult-to-treat cancers as quickly and safely as possible, the incidence of KRAS mutations and the promise of targeted therapies for patients with such mutations, the success of current and future relationships with third-party collaborators and academic partners, and the potential ability of our product candidates to treat genetically driven diseases and cancers with clear genetic drivers, reflect our current views about our plans, intentions, expectations, strategies and prospects, and are based on the information currently available to us and on assumptions we have made and are not forecasts, promises nor guarantees. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by these forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved.  Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, the success of our product candidates to treat genetically driven diseases and cancers with clear genetic drivers, the success of our collaboration with Bristol Myers Squibb, as well as those risks set forth in the Risk Factors section of BridgeBio's most recent Annual Report on Form 10-K and BridgeBio's other SEC filings. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

    BridgeBio Contact:

    Grace Rauh

    BridgeBio Pharma, Inc.

    Grace.rauh@bridgebio.com

    (917) 232-5478

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  8. PALO ALTO, Calif., July 12, 2021 /PRNewswire/ -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a commercial-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, today announced that on July 1, 2021, the compensation committee of BridgeBio's board of directors granted 20 new employees restricted stock units for an aggregate of 26,761 shares of the Company's common stock. All of the above-described awards were made under BridgeBio's 2019 Inducement Equity Plan (the Plan).

    The above-described awards were each granted as an inducement material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4), and were granted pursuant to the terms of the Plan. The Plan was adopted by BridgeBio's board of directors in November 2019.

    About BridgeBio

    BridgeBio is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio's pipeline of over 30 development programs ranges from early science to advanced clinical trials and its commercial organization is focused on delivering the Company's first approved therapy. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com.

    Media Contact:

    Grace Rauh

    Grace.rauh@bridgebio.com

    (917) 232-5478

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/bridgebio-pharma-reports-inducement-grants-under-nasdaq-listing-rule-5635c4-301331891.html

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  9. PALO ALTO, Calif., July 8, 2021 /PRNewswire/ -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a commercial-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, today announced three new academic collaborations with MUSC Foundation for Research Development, Stanford University and the University of Pittsburgh (Pitt) to translate cutting-edge discoveries into potential therapies for patients with genetic diseases and genetically driven cancers.

    "The chance to partner with exceptional researchers at the Medical University of South Carolina, Stanford University and University of Pittsburgh is a privilege, and we believe will help us advance our mission to discover, create, test and deliver life-changing medicines for patients in need as rapidly as possible," said BridgeBio founder and CEO Neil Kumar, Ph.D.

    To date, BridgeBio has worked with 23 leading institutions throughout the country that are focused on providing treatment options to patients as quickly and safely as possible. For a list of some of the institutions BridgeBio is partnered with, please visit Our Partners page.

    MUSC Foundation for Research Development

    MUSC Foundation for Research Development provides technology transfer services to Medical University of South Carolina (MUSC), which is a patient-centric research institution with several hospitals in South Carolina and is considered the state's top healthcare provider. MUSC's innovative and high-quality research will allow for early identification of research programs with a strong potential to be beneficial for patients. Through this partnership, BridgeBio may sponsor research programs and support the development of identified programs toward potential clinical investigation through its licensing and affiliate development model.

    "Like BridgeBio, we have a patients first mentality, so partnering together on early research will be an excellent opportunity to advance our innovation in the hope of generating new therapies for patients," said Scott Davis, Ph.D., senior director of innovation support and commercialization of MUSC Foundation for Research Development.

    Stanford University

    This formal collaboration between BridgeBio and Stanford is focused on unlocking new discoveries and working to provide valuable treatment options to patients with unmet needs. BridgeBio will work with Stanford researchers to identify new potential therapies with the possibility of BridgeBio providing support for these programs and potentially advancing them into clinical trials and commercializing new medicines.

    The University of Pittsburgh (Pitt)

    Pitt is one of the leading research institutions in the United States with broad strengths spanning basic research to clinical translation. BridgeBio intends to collaborate with Pitt to identify and support the development of potential novel therapies for patients with genetic diseases and cancers with clear genetic drivers.

    "We are very excited to grow our partnership with BridgeBio," said Rob A. Rutenbar, Ph.D., senior vice chancellor for research at Pitt. "Bringing together Pitt's leading medical research enterprise with the drug development expertise of BridgeBio serves our common goal of developing life-saving therapies for those patients most in need."

    About BridgeBio Pharma, Inc.

    BridgeBio Pharma (BridgeBio) is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio's pipeline of over 30 development programs ranges from early science to advanced clinical trials and its commercial organization is focused on delivering the company's first two approved therapies. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com.

    BridgeBio Pharma, Inc. Forward-Looking Statements

    This press release contains forward-looking statements. Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), which are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions.  We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions.  These forward-looking statements, including statements relating to expectations, plans, and prospects regarding our partnering with MUSC Foundation for Research Development on early research as an opportunity to advance innovation in the hope of generating new therapies for patients, the success of formal collaboration with Stanford to unlock new discoveries and provide valuable treatment options to patients with unmet needs, the success of our collaboration with Pitt in identifying and supporting the development of potential novel therapies for patients with genetic diseases and cancers with clear genetic drivers, the success of current and future relationships with third-party collaborators and academic partners, and the potential ability of our product candidates to treat genetically driven diseases and cancers with clear genetic drivers, reflect our current views about our plans, intentions, expectations, strategies and prospects, and are based on the information currently available to us and on assumptions we have made and are not forecasts, promises nor guarantees. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by these forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved.  Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, the success of our product candidates to treat genetically driven diseases and cancers with clear genetic drivers, the success of our academic collaborations with each of MUSC Foundation for Research Development, Stanford University and Pitt, as well as those risks set forth in the Risk Factors section of BridgeBio Pharma's most recent Annual Report on Form 10-K and BridgeBio Pharma's other SEC filings. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

    BridgeBio Contact:

    Grace Rauh

    BridgeBio Pharma, Inc.

    Grace.rauh@bridgebio.com

    (917) 232-5478

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  10. REDWOOD CITY, Calif., June 28, 2021 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea") (NASDAQ:BMEA), a preclinical-stage biopharmaceutical company focused on the discovery and development of irreversible small molecules to treat patients with genetically defined cancers, announced the appointment of Franco Valle as Chief Financial Officer. Mr. Valle is an accomplished financial expert who brings extensive experiences to Biomea, in particular with building the necessary infrastructure to support clinical and operational growth within biotech companies. Mr. Valle will also assume the role of Principal Financial Officer and Principal Accounting Officer upon joining.

    Recently, Mr. Valle served as Principal Accounting Officer & Senior Vice…

    REDWOOD CITY, Calif., June 28, 2021 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea") (NASDAQ:BMEA), a preclinical-stage biopharmaceutical company focused on the discovery and development of irreversible small molecules to treat patients with genetically defined cancers, announced the appointment of Franco Valle as Chief Financial Officer. Mr. Valle is an accomplished financial expert who brings extensive experiences to Biomea, in particular with building the necessary infrastructure to support clinical and operational growth within biotech companies. Mr. Valle will also assume the role of Principal Financial Officer and Principal Accounting Officer upon joining.

    Recently, Mr. Valle served as Principal Accounting Officer & Senior Vice President of Finance at Eidos (NASDAQ:EIDX), a former publicly traded, clinical-stage biopharmaceutical company, which merged with BridgeBio (NASDAQ:BBIO) for $2.83 Billion earlier in 2021. Prior to Eidos, Mr. Valle served as the Principal Accounting Officer and Controller at Iovance Biotherapeutics (NASDAQ:IOVA) from 2016 until 2018. Mr. Valle also worked at Pharmacyclics , which he joined in 2012 and supported through its merger with Abbvie  as Senior Accounting Officer of the company. Mr. Valle is a certified public accountant and started his career in 2005 at Pricewaterhouse Coopers LLP, where he spent six years in the Life Science, Biotech and Venture Capital Group.

    "I am really excited to welcome Franco to our leadership team," said Tom Butler, Biomea's CEO and Chairman of the Board. "His extensive experience in financial operations will help us build systems that will support our growth as we develop our pipeline of preclinical and clinical assets. We are on track to submit our IND to the FDA for BMF-219 during the second half of this year, and our strong balance sheet provides us ample funding not only to fully explore BMF-219 in multiple tumor types, but also to build out our proprietary irreversible platform, and progress multiple earlier stage pipeline molecules into the clinic. On behalf of the entire Biomea team, I welcome Franco and look forward to his contributions."

    "I have worked together with Franco in the past, and I could not be happier he joined as the CFO of Biomea," said Eric Aguiar, M.D., Lead Director and Chairman of the Audit Committee at Biomea. "Franco is very knowledgeable, structured, and will help Biomea continue to build organizational systems to grow and support the full clinical exploration of Biomea's portfolio of small molecules."

    "I am thrilled to join Biomea, particularly on the heels of its successful IPO in April and strong pipeline of clinical catalysts. I have worked with many of the leadership in the past and know first-hand their track record and commitment to develop novel irreversible small molecules that transform treatments in a targeted, patient friendly manner," said Mr. Valle.

    Mr. Valle will be joined by Terrie Phan, who will become Vice President and Corporate Controller of Biomea. Ms. Phan is also a licensed CPA and has worked most of her career supporting growth-oriented biotech companies, serving as a Controller, expert Accounting Manager as well as a Financial Planner and SOX Compliance Manager. Mr. Valle will assume the financial leadership from Sunny Lee. The company thanks Ms. Lee for her contributions and support during the IPO process and the transition from being a private company to a public corporation.

    About Biomea Fusion

    Biomea Fusion is a preclinical-stage biopharmaceutical company focused on the discovery and development of irreversible small molecules to treat patients with genetically defined cancers. An irreversible small molecule drug is a synthetic compound that forms a permanent bond to its target protein and offers a number of potential advantages over conventional reversible drugs, including greater target selectivity, lower drug exposure and the ability to drive a deeper, more durable response. Leveraging its extensive expertise in irreversible binding chemistry and development, the Company built its proprietary FUSION System discovery platform to advance a pipeline of novel irreversible, small molecule therapies. The lead product candidate, BMF-219, is an orally bioavailable, potent and selective irreversible inhibitor of menin, an important transcriptional regulator known to play a direct role in oncogenic signaling in multiple cancers. In preclinical studies, administration of BMF-219 has resulted in robust anti-tumor responses across a range of liquid and solid tumor models and has been well-tolerated in animal studies. Biomea Fusion is developing BMF-219 for the treatment of liquid and solid tumors that are highly dependent on menin, including leukemias containing the mixed lineage leukemia ("MLL") fusion protein. The Company is currently completing investigational new drug ("IND") enabling studies and expects to file an IND application with the U.S. Food and Drug Administration in the second half of 2021. Beyond BMF-219, the Company is utilizing its novel platform to develop irreversible treatments against other high-value oncogenic drivers of cancer and expects to nominate its second development candidate in the first half of 2022. Biomea Fusion's goal is to utilize its capabilities and platform to become a leader in developing irreversible small molecules in order to maximize the depth and durability of clinical benefit when treating various cancers.

    Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the potential safety, efficacy, and continued development of BMF-219, the timing for completing the IND filing or starting the clinical development, the building out our proprietary irreversible platform and progress made in early-stage small pipeline molecules through their preclinical development, including the timing for nominating development candidates in each program. These statements often include words such as "believe," "expect," "anticipate," "intend," "plan," "estimate," "seek," "will," "may," or similar expressions. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company's control. Any forward-looking statements in this statement are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of the Company's product candidate development activities and planned IND-enabling and clinical trials, the Company's ability to execute on its strategy, regulatory developments in the United States, the Company's ability to fund operations, and the impact that the current COVID-19 pandemic will have on the Company's clinical trials and pre-clinical studies, supply chain, and operations, as well as those risks and uncertainties set forth in the Company's Quarterly Report on Form Q for the quarter ended March 31, 2021, filed with the Securities and Exchange Commission on May 27, 202, and its other filings filed with the United States Securities and Exchange Commission filed from time. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Biomea Contact:

    Ramses Erdtmann

    President - Biomea Fusion, Inc.

    re@biomeafusion.com

    Phone: 805-455-1313



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  11. PALO ALTO, Calif., June 14, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a commercial-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, today announced that on June 1, 2021, the compensation committee of BridgeBio's board of directors granted 21 new employees restricted stock units for an aggregate of 47,963 shares of the Company's common stock. All of the above-described awards were made under BridgeBio's 2019 Inducement Equity Plan (the Plan).

    The above-described awards were each granted as an inducement material to the employees entering into employment with the Company in accordance with Nasdaq…

    PALO ALTO, Calif., June 14, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a commercial-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, today announced that on June 1, 2021, the compensation committee of BridgeBio's board of directors granted 21 new employees restricted stock units for an aggregate of 47,963 shares of the Company's common stock. All of the above-described awards were made under BridgeBio's 2019 Inducement Equity Plan (the Plan).

    The above-described awards were each granted as an inducement material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4), and were granted pursuant to the terms of the Plan. The Plan was adopted by BridgeBio's board of directors in November 2019.

    About BridgeBio

    BridgeBio is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio's pipeline of over 30 development programs ranges from early science to advanced clinical trials and its commercial organization is focused on delivering the Company's first approved therapy. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com.

    Media Contact:

    Grace Rauh

    Grace.rauh@bridgebio.com

    (917) 232-5478

    Source: BridgeBio Pharma, Inc.



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  12. PALO ALTO, Calif., June 01, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a commercial-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for encaleret for the treatment of autosomal dominant hypocalcemia (ADH1). The FDA Fast Track designation program is designed to facilitate the development and to expedite the review of new therapies hoping to treat or prevent serious conditions and fill an unmet medical need. BridgeBio announced the Fast Track designation on World Hypoparathyroidism Awareness Day, an annual…

    PALO ALTO, Calif., June 01, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a commercial-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for encaleret for the treatment of autosomal dominant hypocalcemia (ADH1). The FDA Fast Track designation program is designed to facilitate the development and to expedite the review of new therapies hoping to treat or prevent serious conditions and fill an unmet medical need. BridgeBio announced the Fast Track designation on World Hypoparathyroidism Awareness Day, an annual global awareness and education event designed to spotlight and support people living with ADH1 and other types of hypoparathyroidism.

    ADH1 is a rare, genetic form of hypoparathyroidism caused by pathogenic variants in the calcium-sensing receptor gene (CASR). It is estimated that about 12,000 individuals in the United States carry such variants in CASR.1 The calcium-sensing receptor gene encodes the receptor, CaSR, which senses the level of calcium in the body and regulates the amount of calcium in the blood through its effects on the parathyroid glands, the kidney, and bone. Gain-of-function variants in CASR result in sensing low calcium as normal. As a result, patients with ADH1 have low blood calcium (hypocalcemia), low or low-normal parathyroid hormone levels, and excess urinary excretion of calcium (hypercalciuria). Hypocalcemia can cause severe muscle cramping and seizures, while hypercalciuria can lead to impaired kidney function and kidney stone formation. The current standard-of-care for ADH1 patients consists of oral calcium supplements in excess of typical dietary requirements for people with normal CaSR function, and activated vitamin D, which can partially correct hypocalcemia but typically worsens both hypoparathyroidism and hypercalciuria.

    "Balancing near-normal blood and avoiding excess urinary calcium is a daily struggle for patients with ADH1 as the range of symptoms produced by the highs and lows of the condition cannot adequately be addressed by current standard-of-care," said Jonathan Fox, M.D., Ph.D., Chief Medical Officer of the cardio-renal affiliates at BridgeBio, including Calcilytix, which is focused on developing encaleret. "With respect to the mechanism of disease, which is driven by gain-of-function variants in CASR, encaleret, as an allosteric negative modulator of the receptor's calcium sensing activity, has the potential to correct the disease mechanism at its source. It is encouraging to receive Fast Track designation from the FDA as it recognizes the seriousness of ADH1 and the potential for encaleret to address this profound unmet medical need."

    Promising early results from its ongoing Phase 2b proof-of-concept, open-label study of encaleret, orally administered, for patients with ADH1 were presented at the Endocrine Society's 2021 Annual Meeting, which showed the normalization of blood calcium and urine calcium in six of six (100%) ADH1 participants evaluated over five days and demonstrated clinical proof-of-concept.2 BridgeBio plans to engage with regulatory health authorities to discuss the design of a Phase 3 registrational study in patients with ADH1. If the development program is successful, encaleret could be the first approved therapy indicated specifically for the treatment of ADH1.

    For more information on the Phase 2b clinical trial currently recruiting participants with ADH1, please visit clinicaltrials.gov (Identifier: NCT04581629).

    [1] Dershem et al., Amer Jour of Hum Genetics, 2020.

    [2] Gafni et al., Jour of Endo Soc, 2021.

    About BridgeBio Pharma, Inc.

    BridgeBio Pharma (BridgeBio) is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio's pipeline of over 30 development programs ranges from early science to advanced clinical trials and its commercial organization is focused on delivering the company's first approved therapy. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com.

    BridgeBio Pharma Forward-Looking Statements

    This press release contains forward-looking statements. Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements relating to expectations, plans and prospects regarding the preclinical and clinical development plans, clinical trial designs, clinical and therapeutic potential, and strategy of our product candidates, including, but not limited to: early results from our ongoing Phase 2b proof-of-concept, open-label study of encaleret for the treatment of Autosomal Dominant Hypocalcemia Type 1 (ADH1) being indicative of final data from our Phase 2b study of encaleret; the potential size of the target patient population for ADH1; the inability of current standard-of-care therapies to treat ADH1; the timing and success of our planned meetings with regulatory health authorities, including the U.S. Food and Drug Administration (FDA), in 2021, including regarding the design of a Phase 3 registrational study in patients with ADH1; the ability of encaleret to be the first approved therapy option indicated specifically for the treatment of ADH1, if the development program is successful; the unknown future impact of the COVID-19 pandemic delay on our ongoing clinical trials and/or our operations or operating expenses; and the timing of these events, reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to: early data from our ongoing Phase 2b proof-of-concept, open-label study of encaleret for the treatment of ADH1 not being indicative of final data; encaleret not being the first approved therapy option indicated specifically for the treatment of ADH1, if the development program is not successful or if a competing therapy option is approved; despite having ongoing and future interactions with the FDA or other regulatory agencies to discuss potential paths to registration prior to initiation of a Phase 3 registrational study of encaleret in patients with ADH1, the FDA or such other regulatory agencies may not agree with our regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those risks set forth in the Risk Factors section of our most recent quarterly or annual periodic report filed with the U.S. Securities and Exchange Commission (SEC) and our other SEC filings. Moreover, BridgeBio operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of BridgeBio's management as of the date of this release and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

    BridgeBio Contact:

    Grace Rauh

    BridgeBio Pharma, Inc.

    Grace.rauh@bridgebio.com

    (917) 232-5478

    Patient Advocacy Contact:

    Jocelyn Ashford

    BridgeBio Pharma, Inc.

    jocelyn.ashford@bridgebio.com

    (650) 452-4199

    Source: BridgeBio Pharma, Inc.



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    • Pivotal study demonstrated a clinically meaningful rate of tumor shrinkage (overall response rate) and duration of response in patients with previously-treated advanced cholangiocarcinoma (CCA) harboring an FGFR2 fusion or rearrangement
    • BridgeBio, through its affiliate QED ("BridgeBio"), and Helsinn will co-commercialize TRUSELTIQ in the U.S.
    • TRUSELTIQ is BridgeBio's first FDA approved therapeutic in oncology and second approved therapeutic this year

    BridgeBio Pharma, Inc. (NASDAQ:BBIO), through its affiliate QED Therapeutics, Inc., and Helsinn Group today announced that the US Food and Drug Administration (FDA) has approved TRUSELTIQ™ (infigratinib) under the accelerated approval program for the treatment of patients with previously-treated…

    • Pivotal study demonstrated a clinically meaningful rate of tumor shrinkage (overall response rate) and duration of response in patients with previously-treated advanced cholangiocarcinoma (CCA) harboring an FGFR2 fusion or rearrangement
    • BridgeBio, through its affiliate QED ("BridgeBio"), and Helsinn will co-commercialize TRUSELTIQ in the U.S.
    • TRUSELTIQ is BridgeBio's first FDA approved therapeutic in oncology and second approved therapeutic this year

    BridgeBio Pharma, Inc. (NASDAQ:BBIO), through its affiliate QED Therapeutics, Inc., and Helsinn Group today announced that the US Food and Drug Administration (FDA) has approved TRUSELTIQ™ (infigratinib) under the accelerated approval program for the treatment of patients with previously-treated locally advanced or metastatic cholangiocarcinoma (CCA) harboring an FGFR2 fusion or rearrangement. TRUSELTIQ is an orally administered, ATP-competitive, tyrosine kinase inhibitor of FGFR. In the pivotal trial of patients with advanced, unresectable CCA, an aggressive malignancy with poor prognosis, TRUSELTIQ led to cases of tumor shrinkage. CCA is known to affect approximately 20,000 people in the United States and European Union each year and has a median five-year survival rate of only 9%.1

    "This is an important milestone for patients diagnosed with FGFR2-fusion-driven cholangiocarcinoma who have recurred after first-line therapy and are in need of targeted options for further treatment," said Susan Moran, M.D., M.S.C.E., Chief Medical Officer for QED. "Based on the efficacy seen to date, our team believes infigratinib possesses promise for a range of FGFR-driven conditions, including other cancers. We will continue to evaluate its safety and efficacy in these areas of unmet need."

    The approval of TRUSELTIQ is based on a Phase 2 clinical study in which 108 patients who had undergone at least one prior treatment for advanced CCA received 125 mg of TRUSELTIQ daily for 21 days of 28-day cycles. Of these patients, 107 (99%) had Stage IV CCA. All patients had received at least 1 prior line of systemic therapy. The study's primary endpoint demonstrated a confirmed objective response rate (ORR) of 23% (95% CI 16-32%). The study also showed a median duration of response (DOR) of 5.0 months (95% CI 3.7–9.3 months). Common adverse reactions and laboratory abnormalities (of >30%) were increased creatinine, increased phosphate, decreased phosphate, nail toxicity, stomatitis, increased alkaline phosphatase, decreased hemoglobin, increased alanine aminotransferase, dry eye, fatigue, increased lipase, decreased lymphocytes, increased calcium, decreased sodium, alopecia, increased triglycerides, increased aspartate aminotransferase, decreased platelets, increased urate, palmar-plantar erythrodysesthesia syndrome, arthralgia, and dysgeusia. Please see below for additional important safety information for TRUSELTIQ.

    The above data were presented at the 2021 American Society of Clinical Oncology Gastrointestinal Cancers Symposium by the lead investigator, Milind Javle, M.D., Professor of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center.

    "While targeted treatments have extended survival for many types of cancer, people diagnosed with cholangiocarcinoma have previously been presented with extremely limited treatment options coupled with low statistical survival data," said Dr. Javle. "In this study, TRUSELTIQ showed promise as a targeted treatment option for patients with FGFR2-fusion-driven cholangiocarcinoma with a well-tolerated safety profile in line with previous observations in this patient population."

    "The approval of TRUSELTIQ provides a new and exciting treatment option for patients with CCA harboring an FGFR2 fusion," said Stacie Lindsey, Chief Executive Officer of the Cholangiocarcinoma Foundation. "We appreciate the fact that there is a robust patient support program, ForgingBridges, to help patients access care and support them throughout their treatment journey."

    Additional marketing applications for infigratinib are currently under review in Australia and Canada under Project Orbis, an initiative of the FDA's Oncology Center of Excellence that allows for concurrent submission and review of oncology drugs among participating international regulatory agencies.

    BridgeBio and Helsinn Group's affiliate, Helsinn Therapeutics (U.S.), Inc., will be jointly responsible for commercialization activities in the U.S. and will share U.S. profits and losses on an equal basis. Helsinn Group will have exclusive commercialization rights on infigratinib outside of the U.S., excluding China, Hong Kong and Macau. BridgeBio will be eligible for tiered royalties as a percentage of adjusted net sales, and payments totaling up to approximately $2.45 billion USD in the aggregate. Helsinn Group will fund the majority of ongoing and future research and development related to infigratinib in oncology. BridgeBio and Helsinn Group entered into a global collaboration and licensing agreement in March 2021. BridgeBio previously entered a strategic collaboration with LianBio for development and commercialization of infigratinib in oncology indications in China, Hong Kong and Macau.

    Paul Rittman, Chief Executive Officer of Helsinn Therapeutics, said, "Today's FDA approval of TRUSELTIQ for patients with previously-treated locally advanced or metastatic CCA harboring an FGFR2 fusion or rearrangement provides a new therapy option for patients with a very low rate of survival. This new therapy has the potential to make a life changing impact on patients with few treatment options, and Helsinn Therapeutics looks forward to working with BridgeBio to make it widely accessible to health care providers and patients in the US."

    ForgingBridges | TRUSELTIQ is a comprehensive patient support program designed specifically to provide education, access and affordability resources for patients during their TRUSELTIQ journey. For more information, visit: TRUSELTIQ.com/forgingbridges-overview.

    Visit TRUSELTIQ.com for more information, including full Prescribing Information.

    About TRUSELTIQ™ (infigratinib)

    TRUSELTIQ (infigratinib) is an orally administered, ATP-competitive, tyrosine kinase inhibitor of FGFR, approved for the treatment of individuals with FGFR2 fusion-driven cholangiocarcinoma (bile duct cancer). TRUSELTIQ targets the fibroblast growth factor receptor (FGFR) protein, blocking downstream activity. In clinical studies, TRUSELTIQ demonstrated a clinically meaningful rate of tumor shrinkage (overall response rate) and duration of response. Visit TRUSELTIQ.com for more information. Infigratinib is not FDA approved for any other indication in the U.S. and is not approved for use by any other health authority. It is currently being evaluated in clinical studies for first-line cholangiocarcinoma and urothelial carcinoma (bladder cancer). For more information, visit QEDTx.com.

    About Cholangiocarcinoma (CCA)

    Cholangiocarcinoma, a cancer of the bile ducts of the liver, is a serious and often fatal disease which affects approximately 20,000 people in the United States and European Union each year. FGFR2 genetic aberrations are present in approximately 15% to 20% of people who have this disease. Currently, the five-year survival rate is only 9%.1 Advanced, unresectable CCA is a rare, aggressive malignancy with a poor prognosis.

    Clinical Studies1

    The efficacy of TRUSELTIQ was based on a single-arm Phase 2 study which included 108 patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement. Ninety-nine percent of patients had metastatic (Stage IV) disease at the time of study entry.

    These 108 adult patients with advanced/metastatic CCA received infigratinib 125 mg orally for 21 days of each 28-day cycle until unacceptable toxicity or disease progression. All patients received prophylaxis with the oral phosphate binder sevelamer. TRUSELTIQ achieved a 23% objective response rate (ORR) and a median duration of response (DOR) of 5.0 months.

    U.S. Indication for TRUSELTIQ

    TRUSELTIQ is indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.

    Accelerated approval was granted based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

    U.S. Important Safety Information for TRUSELTIQ

    Warnings and precautions

    • Ocular toxicity: Retinal pigment epithelial detachment (RPED), which may cause blurred vision, occurred in 11% of 351 patients treated with TRUSELTIQ, including patients with asymptomatic RPED, with a median onset of 26 days. Perform comprehensive ophthalmological exam including optical coherence tomography prior to initiating, at 1 month, at 3 months, and then every 3 months during treatment with TRUSELTIQ. Urgently evaluate patients for onset of visual symptoms and follow up every 3 weeks until resolved or TRUSELTIQ is discontinued. Withhold TRUSELTIQ as recommended. Dry eye occurred in 29% of 351 patients; treat with ocular demulcents as needed
    • Hyperphosphatemia and soft tissue mineralization: Hyperphosphatemia, which can lead to soft tissue mineralization, cutaneous calcinosis, non-uremic calciphylaxis, vascular calcification, and myocardial calcification, occurred in 82% of 351 patients treated with TRUSELTIQ, with a median time to onset of 8 days (range 1-349); 83% of 351 patients treated with TRUSELTIQ received phosphate binders. Monitor for hyperphosphatemia throughout treatment. Initiate phosphate-lowering therapy for serum phosphate >5.5 mg/dL; withhold TRUSELTIQ and initiate phosphate-lowering therapy for serum phosphate >7.5 mg/dL; withhold, reduce the dose, or permanently discontinue TRUSELTIQ based on duration and severity of hyperphosphatemia
    • Embryo-fetal toxicity: TRUSELTIQ can cause fetal harm. Advise pregnant women of the potential risk to the fetus; advise females of reproductive potential and men who are partnered with women of reproductive potential to use effective contraception during treatment with TRUSELTIQ and for 1 month after the final dose

    Adverse reactions

    • Most common adverse reactions (incidence ≥20%, all grades): nail toxicity, stomatitis, dry eye, fatigue, alopecia, palmar-plantar erythrodysesthesia syndrome, arthralgia, dysgeusia, constipation, abdominal pain, dry mouth, eyelash changes, diarrhea, dry skin, decreased appetite, blurred vision, and vomiting
    • Most common laboratory abnormalities (incidence ≥20%, all grades): increased creatinine, increased phosphate, decreased phosphate, increased alkaline phosphatase, decreased hemoglobin, increased alanine aminotransferase, increased lipase, increased calcium, decreased lymphocytes, decreased sodium, increased triglycerides, increased aspartate aminotransferase (AST), increased urate, decreased platelets, decreased leukocytes, decreased albumin, increased bilirubin, and decreased potassium

    Drug interactions

    • CYP3A inhibitors: Avoid use with strong and moderate CYP3A inhibitors
    • CYP3A inducers: Avoid use with strong and moderate CYP3A inducers
    • Gastric acid–reducing agents: Avoid coadministration with proton pump inhibitors, histamine-2 receptor antagonists (H2RA), and locally acting antacids. If coadministration of H2RA or locally acting antacids cannot be avoided, separate TRUSELTIQ administration
      • H2RA: Take TRUSELTIQ 2 hours before or 10 hours after
      • Locally-acting antacid: Take TRUSELTIQ 2 hours before or 2 hours after

    Dosage and administration

    • Prior to initiating TRUSELTIQ: Confirm FGFR2 fusion or rearrangement; perform comprehensive ophthalmic exam including OCT; confirm negative pregnancy test in females of reproductive potential
    • Starting dose: Take TRUSELTIQ orally once daily on Days 1-21 of 28-day cycles; continue treatment until disease progression or unacceptable toxicity. Take TRUSELTIQ on an empty stomach with a glass of water at least 1 hour before or 2 hours after food
      • No renal or hepatic impairment
        • 125 mg (one 100 mg capsule and one 25 mg capsule)
      • Mild and moderate renal impairment (creatinine clearance 30-89 mL/min)
        • 100 mg (one 100 mg capsule)
      • Mild hepatic impairment (total bilirubin >upper limit of normal [ULN] to 1.5 x ULN or AST > ULN)
        • 100 mg (one 100 mg capsule)
      • Moderate hepatic impairment (total bilirubin >1.5 to 3 x ULN with any AST)
        • 75 mg (three 25 mg capsules)
    • Dose modification: Consult the TRUSELTIQ full Prescribing Information for dose modifications and monitoring recommendations for RPED, hyperphosphatemia, and other Grades 3-4 adverse reactions

    About QED Therapeutics, Inc.

    QED Therapeutics, an affiliate of BridgeBio Pharma, is a biotechnology company focused on precision medicine for FGFR-driven diseases. Its lead investigational candidate is infigratinib (BGJ398), an orally administered, FGFR tyrosine kinase inhibitor that has shown activity that it believes, based on published data to date, to be meaningful in clinical measures, such as overall response rate, in patients with chemotherapy-refractory cholangiocarcinoma with FGFR2 fusions and advanced urothelial carcinoma with FGFR3 genomic alterations. QED submitted a New Drug Application (NDA) with the United States Food and Drug Administration for second- and later-line cholangiocarcinoma in 2020. QED Therapeutics is also evaluating infigratinib in clinical studies for the treatment of achondroplasia. For more information, please visit QEDTx.com.

    About BridgeBio Pharma, Inc.

    BridgeBio is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio's pipeline of over 30 development programs ranges from early science to advanced clinical trials and its commercial organization is focused on delivering the company's first approved therapy. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com.

    About Helsinn Group

    Helsinn is a privately-owned Swiss Pharma Company which, since 1976, has been improving the lives of patients, guided by core family values of respect, integrity and quality. The Group has an extensive portfolio of marketed innovative cancer and rare disease therapies, a robust drug development pipeline and ambitions to further accelerate its growth through in-licensing and acquisitions to address unmet medical needs. Helsinn operates a unique integrated licensing business model, achieving success with long-standing partners in 190 countries, who share our values. The Group's pharmaceutical business (Helsinn Healthcare S.A.) is headquartered in Lugano, Switzerland with operating subsidiaries in the U.S. (Helsinn Therapeutics ((U.S.), Inc.) and China (Helsinn Pharmaceuticals (Beijing) Co., Ltd) which market the Group's products directly in these countries. The Group has additional operating subsidiaries in Switzerland (Helsinn Advanced Synthesis S.A., an active pharmaceutical ingredient manufacturer) and Ireland (Helsinn Birex Pharmaceuticals Ltd, a drug product manufacturer). 3B Future Health Fund (formerly known as Helsinn Investment Fund) was created to enhance the future of healthcare by providing funding and strategic support to innovative companies.

    Helsinn Group plays an active and central role in promoting social transformation in favor of people and the environment. Corporate social responsibility is at the heart of everything we do which is reinforced in the company's strategic plan by a commitment to sustainable growth.

    For more information, please visit helsinn.com and follow us on Twitter, LinkedIn and Vimeo.

    BridgeBio Pharma, Inc. Forward-Looking Statements

    This press release contains forward-looking statements. Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act, and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements relating to: the co-commercialization by QED Therapeutics, Inc. (QED) and partner Helsinn Group (Helsinn) of TRUSELTIQ™ (infigratinib) for the treatment of patients with previously-treated locally advanced or metastatic cholangiocarcinoma (CCA) harboring an FGFR2 fusion or rearrangement in the United States; Helsinn's exclusive commercialization rights outside of the United States, excluding China, Hong Kong and Macau; the success and expected timing of the closing of the BridgeBio and Helsinn global collaboration and licensing agreement; the potential for TRUSELTIQ to treat a range of FGFR-driven conditions, including other cancers; the promise of TRUSELTIQ as a targeted treatment option for patients with FGFR2 fusion driven CCA with a well-tolerated safety profile in line with previous observations in this patient population; the success of QED's comprehensive patient support program, ForgingBridges, designed specifically to provide education, access and affordability resources for patients during their TRUSELTIQ journey; the success of TRUSELTIQ as a new therapy option for patients with previously-treated locally advanced or metastatic CCA harboring an FGFR2 fusion or rearrangement that typically have a very low rate of survival; the efficacy of TRUSELTIQ for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or other rearrangement as detected by a U.S. Food and Drug Administration (FDA)-approved test; the safety profile of TRUSELTIQ for the treatment of patients with FGFR2 fusion driven CCA, including the most common adverse reactions and drug interactions; plans for the supply, manufacturing and distribution of TRUSELTIQ; the incidence and survival rate of CCA; the current FDA-approved TRUSELTIQ dosage and administration; the planned approval of TRUSELTIQ by foreign regulatory authorities and the necessary clinical trial results, and timing and completion of regulatory submissions related thereto; and the competitive environment and clinical and therapeutic potential of TRUSELTIQ; reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation: the safety, tolerability and efficacy profile of TRUSELTIQ observed to date may change adversely in ongoing analyses of trial data or subsequent to commercialization; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with QED's regulatory approval strategies, components of QED's filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data; the fact that accelerated approval of TRUSELTIQ was granted by the FDA based on overall response rate and duration of response, and continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s); QED and/or Helsinn may encounter delays in meeting manufacturing or supply timelines or disruptions in their distribution plans for TRUSELTIQ; whether and when any regulatory submissions may be filed in various foreign jurisdictions and ultimately approved by foreign regulatory authorities; the success and expected closing (and the timing thereof) of the BridgeBio and Helsinn global collaboration and licensing agreement; the continuing success of the BridgeBio and Helsinn global collaboration and licensing agreement and the co-commercialization efforts thereunder; Helsinn's ability to commercialize TRUSELTIQ outside of the United States, excluding China, Hong Kong and Macau; and potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; as well as those set forth in the Risk Factors section of BridgeBio Pharma, Inc.'s most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent SEC filings, which are available on the SEC's website at www.sec.gov. Except as required by law, each of BridgeBio and QED disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. Moreover, BridgeBio and QED operate in a very competitive environment in which new risks emerge from time to time. These forward-looking statements are based on each of BridgeBio's and QED's current expectations, and speak only as of the date hereof.

    References

    1Dhanasekaran, R., Hemming, A. W., Zendejas, I., George, T., Nelson, D. R., Soldevila-Pico, C., Firpi, R. J., Morelli, G., Clark, V., Cabrera, R. "Treatment outcomes and prognostic factors of intrahepatic cholangiocarcinoma". Oncology Reports 29.4 (2013): 1259-1267.

    TRUSELTIQ is a trademark of QED Therapeutics. QED Therapeutics is a member of the BridgeBio family. ForgingBridges is a trademark of BridgeBio.

    US-QEDP-2100002

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  13. Pivotal study demonstrated a clinically meaningful rate of tumor shrinkage (overall response rate) and duration of response in patients with previously-treated advanced cholangiocarcinoma (CCA) harboring an FGFR2 fusion or rearrangement

    BridgeBio, through its affiliate QED ("BridgeBio"), and Helsinn will co-commercialize TRUSELTIQ in the U.S.

    TRUSELTIQ is BridgeBio's first FDA approved therapeutic in oncology and second approved therapeutic this year

    PALO ALTO, Calif. and LUGANO, Switzerland, May 28, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), through its affiliate QED Therapeutics, Inc., and Helsinn Group today announced that the US Food and Drug Administration (FDA) has approved TRUSELTIQ™ (infigratinib) under the…

    Pivotal study demonstrated a clinically meaningful rate of tumor shrinkage (overall response rate) and duration of response in patients with previously-treated advanced cholangiocarcinoma (CCA) harboring an FGFR2 fusion or rearrangement

    BridgeBio, through its affiliate QED ("BridgeBio"), and Helsinn will co-commercialize TRUSELTIQ in the U.S.

    TRUSELTIQ is BridgeBio's first FDA approved therapeutic in oncology and second approved therapeutic this year

    PALO ALTO, Calif. and LUGANO, Switzerland, May 28, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), through its affiliate QED Therapeutics, Inc., and Helsinn Group today announced that the US Food and Drug Administration (FDA) has approved TRUSELTIQ™ (infigratinib) under the accelerated approval program for the treatment of patients with previously-treated locally advanced or metastatic cholangiocarcinoma (CCA) harboring an FGFR2 fusion or rearrangement. TRUSELTIQ is an orally administered, ATP-competitive, tyrosine kinase inhibitor of FGFR. In the pivotal trial of patients with advanced, unresectable CCA, an aggressive malignancy with poor prognosis, TRUSELTIQ led to cases of tumor shrinkage. CCA is known to affect approximately 20,000 people in the United States and European Union each year and has a median five-year survival rate of only 9%.1

    "This is an important milestone for patients diagnosed with FGFR2-fusion-driven cholangiocarcinoma who have recurred after first-line therapy and are in need of targeted options for further treatment," said Susan Moran, M.D., M.S.C.E., Chief Medical Officer for QED. "Based on the efficacy seen to date, our team believes infigratinib possesses promise for a range of FGFR-driven conditions, including other cancers. We will continue to evaluate its safety and efficacy in these areas of unmet need."

    The approval of TRUSELTIQ is based on a Phase 2 clinical study in which 108 patients who had undergone at least one prior treatment for advanced CCA received 125 mg of TRUSELTIQ daily for 21 days of 28-day cycles. Of these patients, 107 (99%) had Stage IV CCA. All patients had received at least 1 prior line of systemic therapy. The study's primary endpoint demonstrated a confirmed objective response rate (ORR) of 23% (95% CI 16-32%). The study also showed a median duration of response (DOR) of 5.0 months (95% CI 3.7–9.3 months). Common adverse reactions and laboratory abnormalities (of >30%) were increased creatinine, increased phosphate, decreased phosphate, nail toxicity, stomatitis, increased alkaline phosphatase, decreased hemoglobin, increased alanine aminotransferase, dry eye, fatigue, increased lipase, decreased lymphocytes, increased calcium, decreased sodium, alopecia, increased triglycerides, increased aspartate aminotransferase, decreased platelets, increased urate, palmar-plantar erythrodysesthesia syndrome, arthralgia, and dysgeusia. Please see below for additional important safety information for TRUSELTIQ.

    The above data were presented at the 2021 American Society of Clinical Oncology Gastrointestinal Cancers Symposium by the lead investigator, Milind Javle, M.D., Professor of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center.

    "While targeted treatments have extended survival for many types of cancer, people diagnosed with cholangiocarcinoma have previously been presented with extremely limited treatment options coupled with low statistical survival data," said Dr. Javle. "In this study, TRUSELTIQ showed promise as a targeted treatment option for patients with FGFR2-fusion-driven cholangiocarcinoma with a well-tolerated safety profile in line with previous observations in this patient population."

    "The approval of TRUSELTIQ provides a new and exciting treatment option for patients with CCA harboring an FGFR2 fusion," said Stacie Lindsey, Chief Executive Officer of the Cholangiocarcinoma Foundation. "We appreciate the fact that there is a robust patient support program, ForgingBridges, to help patients access care and support them throughout their treatment journey."

    Additional marketing applications for infigratinib are currently under review in Australia and Canada under Project Orbis, an initiative of the FDA's Oncology Center of Excellence that allows for concurrent submission and review of oncology drugs among participating international regulatory agencies.

    BridgeBio and Helsinn Group's affiliate, Helsinn Therapeutics (U.S.), Inc., will be jointly responsible for commercialization activities in the U.S. and will share U.S. profits and losses on an equal basis. Helsinn Group will have exclusive commercialization rights on infigratinib outside of the U.S., excluding China, Hong Kong and Macau. BridgeBio will be eligible for tiered royalties as a percentage of adjusted net sales, and payments totaling up to approximately $2.45 billion USD in the aggregate. Helsinn Group will fund the majority of ongoing and future research and development related to infigratinib in oncology. BridgeBio and Helsinn Group entered into a global collaboration and licensing agreement in March 2021. BridgeBio previously entered a strategic collaboration with LianBio for development and commercialization of infigratinib in oncology indications in China, Hong Kong and Macau.

    Paul Rittman, Chief Executive Officer of Helsinn Therapeutics, said, "Today's FDA approval of TRUSELTIQ for patients with previously-treated locally advanced or metastatic CCA harboring an FGFR2 fusion or rearrangement provides a new therapy option for patients with a very low rate of survival. This new therapy has the potential to make a life changing impact on patients with few treatment options, and Helsinn Therapeutics looks forward to working with BridgeBio to make it widely accessible to health care providers and patients in the US."

    ForgingBridges | TRUSELTIQ is a comprehensive patient support program designed specifically to provide education, access and affordability resources for patients during their TRUSELTIQ journey. For more information, visit: TRUSELTIQ.com/forgingbridges-overview.  

    Visit TRUSELTIQ.com for more information, including full Prescribing Information.

    About TRUSELTIQ™ (infigratinib)

    TRUSELTIQ (infigratinib) is an orally administered, ATP-competitive, tyrosine kinase inhibitor of FGFR, approved for the treatment of individuals with FGFR2 fusion-driven cholangiocarcinoma (bile duct cancer). TRUSELTIQ targets the fibroblast growth factor receptor (FGFR) protein, blocking downstream activity. In clinical studies, TRUSELTIQ demonstrated a clinically meaningful rate of tumor shrinkage (overall response rate) and duration of response. Visit TRUSELTIQ.com for more information. Infigratinib is not FDA approved for any other indication in the U.S. and is not approved for use by any other health authority. It is currently being evaluated in clinical studies for first-line cholangiocarcinoma and urothelial carcinoma (bladder cancer). For more information, visit QEDTx.com.

    About Cholangiocarcinoma (CCA)

    Cholangiocarcinoma, a cancer of the bile ducts of the liver, is a serious and often fatal disease which affects approximately 20,000 people in the United States and European Union each year. FGFR2 genetic aberrations are present in approximately 15% to 20% of people who have this disease. Currently, the five-year survival rate is only 9%.1 Advanced, unresectable CCA is a rare, aggressive malignancy with a poor prognosis.

    Clinical Studies1

    The efficacy of TRUSELTIQ was based on a single-arm Phase 2 study which included 108 patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement. Ninety-nine percent of patients had metastatic (Stage IV) disease at the time of study entry.

    These 108 adult patients with advanced/metastatic CCA received infigratinib 125 mg orally for 21 days of each 28-day cycle until unacceptable toxicity or disease progression. All patients received prophylaxis with the oral phosphate binder sevelamer. TRUSELTIQ achieved a 23% objective response rate (ORR) and a median duration of response (DOR) of 5.0 months.

    U.S. Indication for TRUSELTIQ

    TRUSELTIQ is indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.

    Accelerated approval was granted based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

    U.S. Important Safety Information for TRUSELTIQ

    Warnings and precautions

    • Ocular toxicity: Retinal pigment epithelial detachment (RPED), which may cause blurred vision, occurred in 11% of 351 patients treated with TRUSELTIQ, including patients with asymptomatic RPED, with a median onset of 26 days. Perform comprehensive ophthalmological exam including optical coherence tomography prior to initiating, at 1 month, at 3 months, and then every 3 months during treatment with TRUSELTIQ. Urgently evaluate patients for onset of visual symptoms and follow up every 3 weeks until resolved or TRUSELTIQ is discontinued. Withhold TRUSELTIQ as recommended. Dry eye occurred in 29% of 351 patients; treat with ocular demulcents as needed
    • Hyperphosphatemia and soft tissue mineralization: Hyperphosphatemia, which can lead to soft tissue mineralization, cutaneous calcinosis, non-uremic calciphylaxis, vascular calcification, and myocardial calcification, occurred in 82% of 351 patients treated with TRUSELTIQ, with a median time to onset of 8 days (range 1-349); 83% of 351 patients treated with TRUSELTIQ received phosphate binders. Monitor for hyperphosphatemia throughout treatment. Initiate phosphate-lowering therapy for serum phosphate >5.5 mg/dL; withhold TRUSELTIQ and initiate phosphate-lowering therapy for serum phosphate >7.5 mg/dL; withhold, reduce the dose, or permanently discontinue TRUSELTIQ based on duration and severity of hyperphosphatemia
    • Embryo-fetal toxicity: TRUSELTIQ can cause fetal harm. Advise pregnant women of the potential risk to the fetus; advise females of reproductive potential and men who are partnered with women of reproductive potential to use effective contraception during treatment with TRUSELTIQ and for 1 month after the final dose

    Adverse reactions

    • Most common adverse reactions (incidence ≥20%, all grades): nail toxicity, stomatitis, dry eye, fatigue, alopecia, palmar-plantar erythrodysesthesia syndrome, arthralgia, dysgeusia, constipation, abdominal pain, dry mouth, eyelash changes, diarrhea, dry skin, decreased appetite, blurred vision, and vomiting
    • Most common laboratory abnormalities (incidence ≥20%, all grades): increased creatinine, increased phosphate, decreased phosphate, increased alkaline phosphatase, decreased hemoglobin, increased alanine aminotransferase, increased lipase, increased calcium, decreased lymphocytes, decreased sodium, increased triglycerides, increased aspartate aminotransferase (AST), increased urate, decreased platelets, decreased leukocytes, decreased albumin, increased bilirubin, and decreased potassium

    Drug interactions

    • CYP3A inhibitors: Avoid use with strong and moderate CYP3A inhibitors
    • CYP3A inducers: Avoid use with strong and moderate CYP3A inducers
    • Gastric acid–reducing agents: Avoid coadministration with proton pump inhibitors, histamine-2 receptor antagonists (H2RA), and locally acting antacids. If coadministration of H2RA or locally acting antacids cannot be avoided, separate TRUSELTIQ administration
      • H2RA: Take TRUSELTIQ 2 hours before or 10 hours after
      • Locally-acting antacid: Take TRUSELTIQ 2 hours before or 2 hours after

    Dosage and administration

    • Prior to initiating TRUSELTIQ: Confirm FGFR2 fusion or rearrangement; perform comprehensive ophthalmic exam including OCT; confirm negative pregnancy test in females of reproductive potential
    • Starting dose: Take TRUSELTIQ orally once daily on Days 1-21 of 28-day cycles; continue treatment until disease progression or unacceptable toxicity. Take TRUSELTIQ on an empty stomach with a glass of water at least 1 hour before or 2 hours after food
      • No renal or hepatic impairment
        • 125 mg (one 100 mg capsule and one 25 mg capsule)
      • Mild and moderate renal impairment (creatinine clearance 30-89 mL/min)
        • 100 mg (one 100 mg capsule)
      • Mild hepatic impairment (total bilirubin >upper limit of normal [ULN] to 1.5 x ULN or AST > ULN)
        • 100 mg (one 100 mg capsule)
      • Moderate hepatic impairment (total bilirubin >1.5 to 3 x ULN with any AST)
        • 75 mg (three 25 mg capsules)
    • Dose modification: Consult the TRUSELTIQ full Prescribing Information for dose modifications and monitoring recommendations for RPED, hyperphosphatemia, and other Grades 3-4 adverse reactions

    About QED Therapeutics, Inc.

    QED Therapeutics, an affiliate of BridgeBio Pharma, is a biotechnology company focused on precision medicine for FGFR-driven diseases. Its lead investigational candidate is infigratinib (BGJ398), an orally administered, FGFR tyrosine kinase inhibitor that has shown activity that it believes, based on published data to date, to be meaningful in clinical measures, such as overall response rate, in patients with chemotherapy-refractory cholangiocarcinoma with FGFR2 fusions and advanced urothelial carcinoma with FGFR3 genomic alterations. QED submitted a New Drug Application (NDA) with the United States Food and Drug Administration for second- and later-line cholangiocarcinoma in 2020. QED Therapeutics is also evaluating infigratinib in clinical studies for the treatment of achondroplasia. For more information, please visit

    For more information, please visit QEDTx.com.

    About BridgeBio Pharma, Inc.

    BridgeBio Pharma, Inc. (BridgeBio) is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio's pipeline of over 30 development programs ranges from early science to advanced clinical trials and its commercial organization is focused on delivering the company's first approved therapy. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com.



    About Helsinn Group

    Helsinn is a privately-owned Swiss Pharma Company which, since 1976, has been improving the lives of patients, guided by core family values of respect, integrity and quality. The Group has an extensive portfolio of marketed innovative cancer and rare disease therapies, a robust drug development pipeline and ambitions to further accelerate its growth through in-licensing and acquisitions to address unmet medical needs. Helsinn operates a unique integrated licensing business model, achieving success with long-standing partners in 190 countries, who share our values. The Group's pharmaceutical business (Helsinn Healthcare S.A.) is headquartered in Lugano, Switzerland with operating subsidiaries in the U.S. (Helsinn Therapeutics ((U.S.), Inc.) and China (Helsinn Pharmaceuticals (Beijing) Co., Ltd) which market the Group's products directly in these countries. The Group has additional operating subsidiaries in Switzerland (Helsinn Advanced Synthesis S.A., an active pharmaceutical ingredient manufacturer) and Ireland (Helsinn Birex Pharmaceuticals Ltd, a drug product manufacturer). 3B Future Health Fund (formerly known as Helsinn Investment Fund) was created to enhance the future of healthcare by providing funding and strategic support to innovative companies.

    Helsinn Group plays an active and central role in promoting social transformation in favor of people and the environment. Corporate social responsibility is at the heart of everything we do which is reinforced in the company's strategic plan by a commitment to sustainable growth.

    For more information, please visit helsinn.com and follow us on Twitter, LinkedIn and Vimeo.

    BridgeBio Pharma, Inc. Forward-Looking Statements

    This press release contains forward-looking statements.  Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions.  We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act, and are making this statement for purposes of complying with those safe harbor provisions.  These forward-looking statements, including statements relating to: the co-commercialization by QED Therapeutics, Inc. (QED) and partner Helsinn Group (Helsinn) of TRUSELTIQ™ (infigratinib) for the treatment of patients with previously-treated locally advanced or metastatic cholangiocarcinoma (CCA) harboring an FGFR2 fusion or rearrangement in the United States; Helsinn's exclusive commercialization rights outside of the United States, excluding China, Hong Kong and Macau; the success and expected timing of the closing of the BridgeBio and Helsinn global collaboration and licensing agreement; the potential for TRUSELTIQ to treat a range of FGFR-driven conditions, including other cancers; the promise of TRUSELTIQ as a targeted treatment option for patients with FGFR2 fusion driven CCA with a well-tolerated safety profile in line with previous observations in this patient population; the success of QED's comprehensive patient support program, ForgingBridges, designed specifically to provide education, access and affordability resources for patients during their TRUSELTIQ journey; the success of TRUSELTIQ as a new therapy option for patients with previously-treated locally advanced or metastatic CCA harboring an FGFR2 fusion or rearrangement that typically have a very low rate of survival; the efficacy of TRUSELTIQ for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or other rearrangement as detected by a U.S. Food and Drug Administration (FDA)-approved test; the safety profile of TRUSELTIQ for the treatment of patients with FGFR2 fusion driven CCA, including the most common adverse reactions and drug interactions; plans for the supply, manufacturing and distribution of TRUSELTIQ; the incidence and survival rate of CCA; the current FDA-approved TRUSELTIQ dosage and administration; the planned approval of TRUSELTIQ by foreign regulatory authorities and the necessary clinical trial results, and timing and completion of regulatory submissions related thereto; and the competitive environment and clinical and therapeutic potential of TRUSELTIQ; reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made.  Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved.  Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation: the safety, tolerability and efficacy profile of TRUSELTIQ observed to date may change adversely in ongoing analyses of trial data or subsequent to commercialization; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with QED's regulatory approval strategies, components of QED's filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data; the fact that accelerated approval of TRUSELTIQ was granted by the FDA based on overall response rate and duration of response, and continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s); QED and/or Helsinn may encounter delays in meeting manufacturing or supply timelines or disruptions in their distribution plans for TRUSELTIQ; whether and when any regulatory submissions may be filed in various foreign jurisdictions and ultimately approved by foreign regulatory authorities; the success and expected closing (and the timing thereof) of the BridgeBio and Helsinn global collaboration and licensing agreement; the continuing success of the BridgeBio and Helsinn global collaboration and licensing agreement and the co-commercialization efforts thereunder; Helsinn's ability to commercialize TRUSELTIQ outside of the United States, excluding China, Hong Kong and Macau; and potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; as well as those set forth in the Risk Factors section of BridgeBio Pharma, Inc.'s most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent SEC filings, which are available on the SEC's website at www.sec.gov.  Except as required by law, each of BridgeBio and QED disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. Moreover, BridgeBio and QED operate in a very competitive environment in which new risks emerge from time to time. These forward-looking statements are based on each of BridgeBio's and QED's current expectations, and speak only as of the date hereof.

    References

    1 Dhanasekaran, R., Hemming, A. W., Zendejas, I., George, T., Nelson, D. R., Soldevila-Pico, C., Firpi, R. J., Morelli, G., Clark, V., Cabrera, R. "Treatment outcomes and prognostic factors of intrahepatic cholangiocarcinoma". Oncology Reports 29.4 (2013): 1259-1267.

    TRUSELTIQ is a trademark of QED Therapeutics. QED Therapeutics is a member of the BridgeBio family. ForgingBridges is a trademark of BridgeBio.

    BridgeBio Media Contact:

    Grace Rauh

    grace.rauh@bridgebio.com

    (917) 232-5478

    Helsinn Group Media Contact:

    Paola Bonvicini

    Group Head of Communication

    Tel: +41 (0) 91 985 21 21

    Info-hhc@helsinn.com

    US-QEDP-2100002

    A Media Snippet accompanying this announcement is available by clicking on the image or link below:



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  14. PALO ALTO, Calif., May 14, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a clinical-stage biopharmaceutical company focused on genetic diseases, today announced that on May 4, 2021, the compensation committee of BridgeBio's board of directors granted 27 new employees restricted stock units for an aggregate of 70,949 shares of the Company's common stock. All of the above-described awards were made under BridgeBio's 2019 Inducement Equity Plan (the Plan).

    The above-described awards were each granted as an inducement material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4), and were granted pursuant to the terms of the Plan. The Plan was adopted by BridgeBio's board…

    PALO ALTO, Calif., May 14, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a clinical-stage biopharmaceutical company focused on genetic diseases, today announced that on May 4, 2021, the compensation committee of BridgeBio's board of directors granted 27 new employees restricted stock units for an aggregate of 70,949 shares of the Company's common stock. All of the above-described awards were made under BridgeBio's 2019 Inducement Equity Plan (the Plan).

    The above-described awards were each granted as an inducement material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4), and were granted pursuant to the terms of the Plan. The Plan was adopted by BridgeBio's board of directors in November 2019.

    About BridgeBio

    BridgeBio is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio's pipeline of over 30 development programs ranges from early science to advanced clinical trials and its commercial organization is focused on delivering the Company's first approved therapy. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com.

    Media Contact:

    Grace Rauh

    Grace.rauh@bridgebio.com

    (917) 232-5478

    Source: BridgeBio Pharma, Inc.



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  15. PALO ALTO, Calif., May 14, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a commercial-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to BBP-631, an investigational adeno-associated virus 5 (AAV5) gene therapy designed for the treatment of congenital adrenal hyperplasia (CAH).

    Fast Track designation, granted by the FDA, is designed to facilitate the development and to expedite the review of new therapies hoping to treat or prevent serious conditions and fill an unmet medical need. Additionally, BBP-631 was…

    PALO ALTO, Calif., May 14, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a commercial-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to BBP-631, an investigational adeno-associated virus 5 (AAV5) gene therapy designed for the treatment of congenital adrenal hyperplasia (CAH).

    Fast Track designation, granted by the FDA, is designed to facilitate the development and to expedite the review of new therapies hoping to treat or prevent serious conditions and fill an unmet medical need. Additionally, BBP-631 was granted Rare Pediatric Disease Designation by the FDA and has received Orphan Drug Designation by the FDA and European Medicines Agency (EMA).

    "The standard-of-care for CAH patients has not changed significantly over the last 50 years, and a gene therapy offers for the first time the possibility that patients may be able to make their own cortisol and aldosterone, at the right times and in the right amounts. The FDA's Fast Track designation reinforces the urgency to address the unmet needs of patients with CAH as quickly and safely as possible. We are grateful to have received Fast Track along with other key designations granted by the FDA and the EMA," said Eric David, M.D., J.D., CEO at BridgeBio Gene Therapy, which is focused on developing gene therapy treatment options for patients in need. "We are eager to initiate our first-in-human Phase 1/2 study. The Investigational New Drug application has been cleared by the FDA and site activation for the study is ongoing, and is expected to begin in the coming months."

    CAH is one of the most prevalent genetic diseases with more than 75,000 cases estimated in the United States and Europe. The disease is caused by deleterious mutations in the gene encoding an enzyme called 21-hydroxylase, leading to lack of endogenous cortisol and aldosterone production. This lack of production causes patients with CAH to be unable to form physiological responses to illnesses and stressors, which can be life-threatening, especially for children. BBP-631 is designed to provide a functional copy of the 21-hydroxylase-encoding gene to help patients produce their own cortisol and aldosterone.

    Additionally, BridgeBio Gene Therapy presented preclinical data from its CAH program on May 13, 2021 at the American Society of Gene & Cell Therapy (ASGCT) annual meeting, being held virtually May 11-14, 2021. The presentation covered three key Investigational New Drug (IND)-enabling studies that informed the anticipated upcoming clinical trial for BBP-631. The IND application has been cleared by the FDA and site activation for initiation of a first-in-human Phase 1/2 study is ongoing, with initial data anticipated in late 2021 or early 2022. At ASGCT, BridgeBio Gene Therapy today will also be presenting preclinical data from its program designed for the treatment of Canavan disease, which is an extremely rare genetic disease starting in infancy with an incidence of approximately one in 100,000 births worldwide.

    "ASGCT is an important opportunity to share the robust preclinical data package underlying our programs. We hope that by rapidly advancing our investigational therapies into the clinic, we will be one step closer to providing CAH and Canavan patients with potential therapeutic relief," said Clayton Beard, senior vice president of research and development at BridgeBio Gene Therapy.

    ASGCT Oral Presentations:

    Intravenous AAV5 Gene Therapy with Human CYP21A1 Corrects Phenotypic Deficiencies of the 21-Hydroxylase Knockout Mouse Model and Demonstrates Durability and Safety in Non-Human Primates and Mice

    Presenter: Rachel Eclov, Ph.D., associate director of preclinical gene therapy at BridgeBio Gene Therapy

    Presentation date/time: Thursday May 13, 2021 at 6:45 – 7:00 p.m. ET

    • The preclinical data presented shows dose-dependent efficacy, dose-dependent biodistribution and no safety concerns in the shared studies.
    • Results from all three studies shared in the presentation support the efficacy and safety for the upcoming Phase 1/2 trial in classic CAH.

    Safety Evaluation of IV-Administered BBP-812, an AAV9-Based Gene Therapy for the Treatment of Canavan Disease, in Mice and Juvenile Cynomolgus Macaques

    Presenter: David Scott, director of nonclinical pharmacology and toxicology at BridgeBio Gene Therapy

    Presentation date/time: Friday, May 14, 2021 at 2:00 – 2:15 p.m. ET

    • The preclinical findings demonstrate safety through IV administration, which will provide superior biodistribution to deep brain regions and avoid potentially invasive brain surgery.
    • The toxicology study shows safety and facilitates a transition into IND and the clinic to begin testing in patients with Canavan disease.

    For more information on the upcoming clinical trial in CAH, please visit clinicaltrials.gov (Identifier: NCT04783181).

    About BridgeBio Pharma, Inc.

    BridgeBio Pharma (BridgeBio) is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio's pipeline of over 30 development programs ranges from early science to advanced clinical trials and its commercial organization is focused on delivering the company's first approved therapy. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com.

    BridgeBio Pharma, Inc. Forward-Looking Statements

    This press release contains forward-looking statements. Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), which are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements relating to expectations, plans and prospects regarding the preclinical and clinical development plans, clinical trial designs, clinical and therapeutic potential, and strategy of our product candidates, including, but not limited to: the unknown future impact of the COVID-19 pandemic delay on our preclinical and clinical development plans and/or our operations or operating expenses; the timing and success of our planned preclinical and clinical development of our development programs, including each of BBP-812 and BBP-631; the timing and success of any such continued preclinical and clinical development and planned regulatory submissions, including for each of BBP-812 and BBP-631; the potential therapeutic and clinical benefits of each of BBP-812 and BBP-631; the potential size of the target patient populations for each of BBP-812 and BBP-631; the potential for BBP-812 to be the first approved therapy for CAH and for BBP-631 to be the first approved therapy for Canavan disease; our expected runway for cash, cash equivalents and marketable securities; and the timing of these events, reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by  a number of risks, uncertainties and assumptions, including, but not limited to: the success of clinical trials, regulatory filings, approvals and/or sales; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with our regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those risks set forth in the Risk Factors section of our most recent quarterly or annual periodic report filed with the SEC and our other SEC filings. Moreover, BridgeBio operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of BridgeBio's management as of the date of this release and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

    BridgeBio Contact:

    Grace Rauh

    BridgeBio Pharma, Inc.

    Grace.rauh@bridgebio.com

    (917) 232-5478



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  16. Received U.S. Food and Drug Administration (FDA) approval for NULIBRY™ (fosdenopterin) for injection as the first therapy to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A

    Reported proof-of-concept data of encaleret in Autosomal Dominant Hypocalcemia Type 1 (ADH1)

    Launched strategic collaboration with Helsinn Group to co-develop and commercialize infigratinib in oncology; BridgeBio eligible to receive payments up to approximately $2.45 billion USD

    Completed acquisition of Eidos Therapeutics, Inc.

    Raised nearly $750 million in gross proceeds through issuance of 2.25% Convertible Senior Notes due in 2029

    Ended quarter with $1,001.3 million in cash, cash equivalents and marketable securities

    Received U.S. Food and Drug Administration (FDA) approval for NULIBRY™ (fosdenopterin) for injection as the first therapy to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A

    Reported proof-of-concept data of encaleret in Autosomal Dominant Hypocalcemia Type 1 (ADH1)

    Launched strategic collaboration with Helsinn Group to co-develop and commercialize infigratinib in oncology; BridgeBio eligible to receive payments up to approximately $2.45 billion USD

    Completed acquisition of Eidos Therapeutics, Inc.

    Raised nearly $750 million in gross proceeds through issuance of 2.25% Convertible Senior Notes due in 2029

    Ended quarter with $1,001.3 million in cash, cash equivalents and marketable securities

    PALO ALTO, Calif., May 06, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) (BridgeBio or the Company), a commercial-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, today reported its financial results for the first quarter ended March 31, 2021 and provided an update on the Company's operations.

    "We measure success by the number of meaningful medicines we are able to develop and deliver to patients. Our first FDA approval in February was a significant milestone for us as a company, but more importantly marked a turning point for MoCD Type A patients and their families, who now have an approved therapy for the first time," said BridgeBio CEO and founder Neil Kumar, Ph.D. "We hit the first of four major clinical data readouts anticipated over the next 12 months, reporting proof-of-concept data for encaleret in ADH1 that offers promise to patients in need. And we entered into a partnership with Helsinn Group, designed to help us reach as many patients as possible living with FGFR-driven cancers through our anticipated upcoming launch of infigratinib."

    Major milestones anticipated in 2021 or early 2022 for BridgeBio's four core value drivers:

    • Acoramidis (AG10) – Transthyretin (TTR) stabilizer for transthyretin amyloid cardiomyopathy (ATTR-CM): Topline results from Part A of the ATTRibute-CM trial are expected in late 2021 or early 2022 and from Part B in 2023. If Part A is successful, BridgeBio expects to submit an application for regulatory approval of acoramidis in 2022. ATTR is a form of amyloidosis caused by the accumulation of misfolded TTR protein. It is estimated to affect more than 400,000 people worldwide and is largely undiagnosed today.

    • Encaleret – Calcium-sensing receptor (CaSR) inhibitor for ADH1: Early results from an ongoing Phase 2 proof-of-concept study shared at the Endocrine Society's 2021 Annual Meeting (ENDO) in March 2021 showed normalization of blood calcium and urine calcium in 6 of 6 (100%) ADH1 participants. If the development program is successful, encaleret could be the first approved therapy for ADH1, a condition caused by gain of function variants in the CaSR gene estimated to be carried by 12,000 individuals in the United States alone.

    • Low-dose infigratinib – FGFR1-3 inhibitor for achondroplasia: Initial data from the ongoing Phase 2 dose ranging study are expected by the end of 2021. Achondroplasia is the most common form of genetic short stature and one of the most common genetic diseases, with a prevalence of greater than 55,000 cases in the United States and European Union. Low-dose infigratinib is the only known product candidate in clinical development for achondroplasia that targets the disease at its genetic source and the only orally administered product candidate in clinical-stage development.

    • BBP-631 – AAV5 gene therapy candidate for congenital adrenal hyperplasia (CAH): Investigational New Drug (IND) application cleared by the FDA and site activation for initiation of a first-in-human Phase 1/2 study is ongoing, with initial data anticipated in late 2021 or early 2022. CAH is one of the most prevalent genetic diseases potentially addressable with AAV gene therapy, with more than 75,000 cases estimated in the United States and European Union. The disease is caused by deleterious mutations in the gene encoding an enzyme called 21-hydroxylase, leading to lack of endogenous cortisol production. BridgeBio's AAV5 gene therapy candidate is designed to provide a functional copy of the 21-hydroxylase-encoding gene (CYP21A2) and potentially address many aspects of the disease course.

    Recent pipeline progress and corporate updates:

    • Received FDA approval for NULIBRY™ (fosdenopterin) for injection in February 2021 as the first therapy to reduce the risk of mortality in patients with MoCD Type A, an ultra-rare, life-threatening genetic disorder that progresses rapidly, results in severe and largely irreversible neurological injury, and has a high infant mortality rate.

    • Launched strategic collaboration with Helsinn Group in March 2021 to co-develop and commercialize infigratinib in oncology. The Company is eligible to receive up to approximately $2.45 billion USD, including over $100.0 million USD in upfront, regulatory and launch milestone payments, and the remainder subject to the achievement of specified commercial milestones, and retains full rights to infigratinib for use in skeletal dysplasias, including for achondroplasia.

    • Completed acquisition of Eidos Therapeutics in January 2021, acquiring of all of the outstanding shares of Eidos common stock that BridgeBio did not already own.

    • Raised nearly $750 million in gross proceeds in February 2021 through issuance of 2.25% Convertible Senior Notes due in 2029. The Company expects current cash, cash equivalents and marketable securities to support its planned operations into 2023.

    • The Phase 3 clinical trial of topical patidegib gel in patients with Gorlin Syndrome, advanced by BridgeBio affiliate PellePharm, failed to meet primary and secondary endpoints, but showed multiple signals of potential activity. Accordingly, the Phase 2 study in high-frequency basal cell carcinoma is being halted. The open-label extension (OLE) study is being continued at present at the behest of the patient foundations and physician leaders in the field. LEO Pharma, which entered into a strategic collaboration with PellePharm in 2018, has terminated its option to acquire PellePharm. PellePharm is currently evaluating its data and engaging the applicable regulatory authorities and potential strategic partners to determine next steps.

    • Dosed first patient in Phase 2 trial of BBP-418 in Limb-Girdle Muscular Dystrophy Type 2i in February 2021.

    • Dosed first healthy volunteer in Phase 1 trial of BBP-671, being developed for the treatment of pantothenate kinase-associated neurodegeneration (PKAN) and organic acidemias (OA), in April 2021.

    • Announced formal partnerships in March 2021 with Brown University, University of California, San Diego, GlycoNet, The Lundquist Institute, Oregon Health & Science University, Roswell Park Comprehensive Cancer Center and University of California, Davis – for a total of 20 partnerships among BridgeBio and leading academic and research institutions to date.

    First Quarter 2021 Financial Results:

    Cash, Cash Equivalents and Marketable Securities

    Cash, cash equivalents and marketable securities, excluding restricted cash, totaled $1,001.3 million as of March 31, 2021, compared to $607.1 million as of December 31, 2020. The net increase in balance of $394.2 million is attributed to $731.4 million in net proceeds received from the issuance of our 2.25% Convertible Senior Notes due 2029 (2029 Notes), offset by a $61.3 million payment related to capped call options and a $50.0 million payment to repurchase shares of BridgeBio common stock, both in relation to the issuance of our 2029 Notes. In connection with our acquisition of Eidos, we also paid $59.1 million in direct transaction costs and $21.3 million to Eidos stockholders who elected cash settlement. The remaining change of $145.5 million primarily related to payments of interest and operating expenses.

    Operating Expenses

    Operating expenses for the three months ended March 31, 2021 were $168.0 million as compared to $102.5 million for the same period in the prior year. The increase in operating expenses of $65.5 million during the period is attributable to the increase in personnel costs resulting from an increase in the number of employees to support the progression in our research and development programs, including our increasing research pipelines, as well as an increase in stock-based compensation related to the achievement of various performance-based milestone compensation arrangements tied to regulatory and development milestones. Stock-based compensation for the three months ended March 31, 2021 was $34.9 million as compared to $10.2 million for the same period in the prior year.

    Our research and development expenses have not been significantly impacted by the global outbreak of COVID-19 for the periods presented. While we experienced some delays in certain of our clinical enrollment and trial commencement activities, we continue to adapt in this unprecedented time to enable alternative site, telehealth and home visits, at-home drug delivery, as well as mitigation strategies with our contract manufacturing organizations. The longer-term impact, if any, of COVID-19 on our operating expenses is currently unknown.

    BRIDGEBIO PHARMA, INC.

    Condensed Consolidated Statements of Operations

    (in thousands, except shares and per share amounts)

     Three Months Ended March 31,
      2021   2020 
     (Unaudited)
    License revenue$462  $ 
    Operating expenses:   
    Research and development 122,559   68,225 
    General and administrative 45,407   34,262 
    Total operating expenses 167,966   102,487 
    Loss from operations (167,504)  (102,487)
    Other income (expense), net:   
    Interest income 394   1,941 
    Interest expense (9,738)  (4,010)
    Other income 5,766   474 
    Total other income (expense), net (3,578)  (1,595)
    Net loss (171,082)  (104,082)
    Net loss attributable to redeemable convertible noncontrolling interests and noncontrolling interests 8,003   12,232 
    Net loss attributable to common stockholders of BridgeBio$(163,079) $(91,850)
    Net loss per share, basic and diluted$(1.18) $(0.78)
    Weighted-average shares used in computing net loss per share, basic and diluted 138,627,729   117,803,438 
            

    BRIDGEBIO PHARMA, INC.

    Condensed Consolidated Balance Sheets

    (In thousands)

     March 31, December 31,
      2021   2020 
    Assets(Unaudited)  (1) 
    Cash and cash equivalents and marketable securities (2)$1,001,320  $607,093 
    Receivable from a related party 462    
    Prepaid expenses and other current assets 25,534   35,731 
    Property and equipment, net 22,816   20,325 
    Operating lease right-of-use assets 12,997   16,508 
    Other assets 30,179   23,931 
    Total assets$1,093,308  $703,588 
        
    Liabilities, Redeemable Convertible Noncontrolling Interests and Stockholders' Equity (Deficit)   
    Accounts payable$10,340  $8,945 
    Accrued liabilities 76,936   75,900 
    LEO call option liability    5,550 
    Operating lease liabilities 17,669   18,472 
    Term loans, current portion 3,646   1,458 
    Term loans, net of current portion 90,762   92,421 
    2029 Notes 731,747    
    2027 Notes 538,690   383,436 
    Other liabilities 11,612   9,520 
    Redeemable convertible noncontrolling interests 1,271   1,630 
    Total BridgeBio stockholders' equity (deficit) (395,294)  57,906 
    Noncontrolling interests 5,929   48,350 
    Total liabilities, redeemable convertible noncontrolling interests and stockholders' equity (deficit)$1,093,308  $703,588 



    (1) The condensed consolidated financial statements as of and for the year ended December 31, 2020 are derived from the audited consolidated financial statements as of that date.
    (2) March 31, 2021 amount includes long-term marketable securities of $82.2 million.

     
        

    About BridgeBio Pharma

    BridgeBio is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio's pipeline of over 30 development programs ranges from early science to advanced clinical trials and its commercial organization is focused on delivering the company's first approved therapy. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com.

    Forward-Looking Statements

    This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), which are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements, including statements relating to the clinical and therapeutic potential of our programs and product candidates, the availability of topline results from Part A and Part B of our ATTRibute-CM trial of acoramidis, our plans to submit an application for regulatory approval of acoramidis, the availability of initial data from our ongoing Phase 2 study of infigratinib for achondroplasia and our ongoing Phase 1/2 study of BBP-631 for CAH, our eligibility to receive future milestone payments under our strategic collaboration with the Helsinn Group and the timing of these events, as well as our anticipated cash runway, reflect our current views about our plans, intentions, expectations and strategies, which are based on the information currently available to us and on assumptions we have made.

    Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our Annual Report on Form 10-K for the year ended December 31, 2020, and our other filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

    Contact:

    Grace Rauh

    BridgeBio Pharma, Inc.

    Grace.rauh@bridgebio.com

    (917) 232-5478

    Source: BridgeBio Pharma, Inc.



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  17. PALO ALTO, Calif., April 13, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), and the University of California, San Diego (UC San Diego) today announced a partnership to translate research in genetically driven conditions into potential therapeutic applications for patients, with a focus on oncology and neurology.

    "UC San Diego is a leading research institution with a top pharmacology department and a strong profile in neurology and oncology. By leveraging their expertise through our collaboration partnership, we hope to advance discoveries into potential treatments as quickly and safely as possible," said BridgeBio founder and CEO Neil Kumar, Ph.D.

    Under this partnership, BridgeBio and UC San Diego will collaborate on identifying…

    PALO ALTO, Calif., April 13, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), and the University of California, San Diego (UC San Diego) today announced a partnership to translate research in genetically driven conditions into potential therapeutic applications for patients, with a focus on oncology and neurology.

    "UC San Diego is a leading research institution with a top pharmacology department and a strong profile in neurology and oncology. By leveraging their expertise through our collaboration partnership, we hope to advance discoveries into potential treatments as quickly and safely as possible," said BridgeBio founder and CEO Neil Kumar, Ph.D.

    Under this partnership, BridgeBio and UC San Diego will collaborate on identifying research programs with strong potential for therapeutic applications that address areas of unmet need. BridgeBio will potentially sponsor research programs and support the development of identified programs toward potential clinical investigation through its licensing and affiliate development model.

    "Our world-renown scientists have deep knowledge into genetically driven conditions. Coupling our cross-disciplinary, flexible approach to advancing research with BridgeBio's developmental expertise and collaborative model presents tremendous opportunity to realize the potential of our work," said UC San Diego Associate Vice Chancellor for Innovation and Commercialization Paul Roben. "I look forward to seeing our collaboration advance around our shared mission to develop life-changing therapies and give patients new hope."

    BridgeBio partners with top academic and research institutions, including UC San Diego, to support early, promising research in genetically driven diseases and cancers with clear genetic drivers. Today BridgeBio also announced formal partnerships with Brown University, GlycoNet, The Lundquist Institute, Oregon Health & Science University, Roswell Park Comprehensive Cancer Center and University of California, Davis – for a total of 20 partnerships between BridgeBio and leading academic and research institutions to date. For a list of some of the institutions BridgeBio is partnered with, please visit Our Partners page.

    With trust, respect and science at the forefront of all collaborations, BridgeBio continuously seeks long-term partnerships with similar institutions that are rooted in trust, engagement, science and respect in order to drive forward its mission of developing life-changing medicines for patients with genetically driven conditions, including in oncology and neurology, as quickly and safely as possible.

    About BridgeBio Pharma

    BridgeBio is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio's pipeline of over 30 development programs ranges from early science to advanced clinical trials and its commercial organization is focused on delivering the company's first approved therapy. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com.

    BridgeBio Pharma Forward-Looking Statements:

    This press release contains forward-looking statements. Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), which are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions.  We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions.  These forward-looking statements, including statements relating to expectations, plans, and prospects regarding our ability to build on the UC San Diego's scientific innovation and genetic disease research and translate them into meaningful medicines for patients in need, the success of current and future relationships with third-party collaborators and academic partners, and the potential ability of our product candidates to treat genetically driven diseases and cancers with clear genetic drivers, reflect our current views about our plans, intentions, expectations, strategies and prospects, and are based on the information currently available to us and on assumptions we have made and are not forecasts, promises nor guarantees. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by these forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved.  Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, the success of our product candidates to treat genetically driven diseases and cancers with clear genetic drivers, the success of our collaboration with the UC San Diego, as well as those risks set forth in the Risk Factors section of BridgeBio Pharma's most recent Annual Report on Form 10-K and BridgeBio Pharma's other SEC filings. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

    UC San Diego Contact:

    Michelle Franklin

    UC San Diego

    m1franklin@ucsd.edu

    BridgeBio Contact:

    Grace Rauh

    BridgeBio Pharma, Inc.

    Grace.rauh@bridgebio.com

    (917) 232-5478



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  18. PALO ALTO, Calif. and SACRAMENTO, Calif., April 13, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) today announced a collaboration with the University of California, Davis (UC Davis), to advance research and the development of investigational medicines for patients with genetically driven conditions and cancers.

    "UC Davis is a top-tier research university and we feel honored to get the chance to collaborate closely with the talented team there as we work to discover, create, test and deliver breakthrough medicines for people who are suffering from genetic diseases," said BridgeBio founder and CEO Neil Kumar, Ph.D.

    Under the agreement, the BridgeBio team will work closely with investigators at UC Davis to seek and evaluate…

    PALO ALTO, Calif. and SACRAMENTO, Calif., April 13, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) today announced a collaboration with the University of California, Davis (UC Davis), to advance research and the development of investigational medicines for patients with genetically driven conditions and cancers.

    "UC Davis is a top-tier research university and we feel honored to get the chance to collaborate closely with the talented team there as we work to discover, create, test and deliver breakthrough medicines for people who are suffering from genetic diseases," said BridgeBio founder and CEO Neil Kumar, Ph.D.

    Under the agreement, the BridgeBio team will work closely with investigators at UC Davis to seek and evaluate potential research projects in genetic disease and precision oncology.

    "We have a great appreciation for BridgeBio's vision to create new pathways that connect innovative research to potential treatments for diseases that may not otherwise be pursued in the marketplace," said Bill Tucker, interim associate vice chancellor for Innovation and Technology Commercialization at UC Davis. "We are thrilled to combine our expertise in the hope of expanding the impact of our research to help those in need."

    BridgeBio collaborates with stand-out academic institutions, including UC Davis, to support research around genetically driven conditions and is focused on rapidly translating findings into meaningful treatments for patients. Today BridgeBio also announced formal partnerships with Brown University, GlycoNet, The Lundquist Institute, Oregon Health & Science University, Roswell Park Comprehensive Cancer Center and University of California, San Diego – for a total of 20 partnerships between BridgeBio and leading academic and research institutions to date. For a list of some of the institutions BridgeBio is partnered with, please visit Our Partners page.

    With a diverse pipeline encompassing investigational therapies for rare diseases and genetically validated cancers, BridgeBio provides the insights and support needed to rapidly progress therapeutic research from labs to clinical development. BridgeBio intends to develop similar long-term partnerships based on trust, engagement, science and respect to support its mission of developing life-changing medicines for patients with genetically driven conditions as quickly and safely as possible.

    About BridgeBio Pharma

    BridgeBio is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio's pipeline of over 30 development programs ranges from early science to advanced clinical trials and its commercial organization is focused on delivering the company's first approved therapy. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com.

    BridgeBio Pharma Forward-Looking Statements

    This press release contains forward-looking statements. Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), which are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements relating to expectations, plans, and prospects regarding our ability to build on the significant advances being made in UC Davis's labs and translate them into meaningful medicines for patients in need, the success of current and future relationships with third-party collaborators and academic partners, and the potential ability of our product candidates to treat genetically driven diseases and cancers, reflect our current views about our plans, intentions, expectations, strategies and prospects, and are based on the information currently available to us and on assumptions we have made and are neither forecasts, promises nor guarantees. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by these forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, the success of our product candidates to treat genetically driven diseases and cancers, the success of our collaboration with UC Davis, as well as those risks set forth in the Risk Factors section of BridgeBio Pharma's most recent Annual Report on Form 10-K and BridgeBio Pharma's other SEC filings. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

    BridgeBio Contact:

    Grace Rauh

    BridgeBio Pharma, Inc.

    Grace.rauh@bridgebio.com

    (917) 232-5478

    UC Davis Contact:

    AJ Cheline

    Director or Marketing and Communications

    UC Davis Office of Research

    acheline@ucdavis.edu

    (530)219-8739



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  19. PALO ALTO, Calif. and BUFFALO, N.Y., April 13, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) today announced a collaboration with Roswell Park Comprehensive Cancer Center to advance the development of investigational therapeutics for patients with genetically driven cancers.

    "We are honored to begin collaborating with Roswell Park, which is renowned for its excellence in cancer research and its mission to set the gold standard for treating patients with genetically driven cancers," said BridgeBio CEO and founder Neil Kumar, Ph.D.

    Under the partnership, BridgeBio will work with scientists at Roswell Park Comprehensive Cancer Center to evaluate new research and development opportunities in oncology that have promise to advance…

    PALO ALTO, Calif. and BUFFALO, N.Y., April 13, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) today announced a collaboration with Roswell Park Comprehensive Cancer Center to advance the development of investigational therapeutics for patients with genetically driven cancers.

    "We are honored to begin collaborating with Roswell Park, which is renowned for its excellence in cancer research and its mission to set the gold standard for treating patients with genetically driven cancers," said BridgeBio CEO and founder Neil Kumar, Ph.D.

    Under the partnership, BridgeBio will work with scientists at Roswell Park Comprehensive Cancer Center to evaluate new research and development opportunities in oncology that have promise to advance and potentially provide clinical benefit for patients. Select therapeutic programs may be pursued by BridgeBio, in close collaboration with Roswell Park Comprehensive Cancer Center scientists, who would remain deeply involved in the ongoing development of these investigational therapies.

    "Collaborating with BridgeBio opens up a platform of new resources to support the incredible Roswell Park innovators working on new ways to care for cancer patients with dire unmet need," said Roswell Park Comprehensive Cancer Center President and CEO Candace S. Johnson, Ph.D. "The ability to tap into this network of expertise means greater visibility for our teams and enables a quicker path to the clinic for our most promising ideas and inventions in areas like genetics, bioinformatics and molecular biology."

    BridgeBio partners with stand-out academic institutions, including Roswell Park Comprehensive Cancer Center, to support research around genetically driven conditions and is focused on rapidly translating findings into meaningful treatments for patients. Today BridgeBio also announced formal partnerships with Brown University, GlycoNet, The Lundquist Institute, Oregon Health & Science University, University of California, Davis and University of California, San Diego – for a total of 20 partnerships between BridgeBio and leading academic and research institutions to date. For a list of some of the institutions BridgeBio is partnered with, please visit Our Partners page.

    With a diverse pipeline encompassing investigational therapies for both rare diseases and genetically validated cancers, BridgeBio provides the insights and support needed to rapidly progress therapeutic research from labs to clinical development. BridgeBio intends to develop similar long-term partnerships based on trust, engagement, science and respect to support its mission of developing life-changing medicines for patients with genetically driven conditions as quickly and safely as possible.

    About Roswell Park Comprehensive Cancer Center

    Roswell Park Comprehensive Cancer Center is a community united by the drive to eliminate cancer's grip on humanity by unlocking its secrets through personalized approaches and unleashing the healing power of hope. Founded by Dr. Roswell Park in 1898, it is the only National Cancer Institute-designated comprehensive cancer center in Upstate New York. Learn more at www.roswellpark.org, or contact us at 1-800-ROSWELL (1-800-767-9355) or ASKRoswell@RoswellPark.org.

    About BridgeBio Pharma

    BridgeBio is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio's pipeline of over 30 development programs ranges from early science to advanced clinical trials and its commercial organization is focused on delivering the company's first approved therapy. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com.

    BridgeBio Pharma Forward-Looking Statements

    This press release contains forward-looking statements. Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), which are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions.  We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions.  These forward-looking statements, including statements relating to expectations, plans, and prospects regarding our ability to build on the significant advances being made in Roswell Park's labs and translate them into meaningful medicines for patients in need, the success of current and future relationships with third-party collaborators and academic partners, and the potential ability of our product candidates to treat genetically driven cancers, reflect our current views about our plans, intentions, expectations, strategies and prospects, and are based on the information currently available to us and on assumptions we have made and are neither forecasts, promises nor guarantees. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by these forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved.  Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, the success of our product candidates to treat genetically driven cancers, the success of our collaboration with Roswell Park, as well as those risks set forth in the Risk Factors section of BridgeBio Pharma's most recent Annual Report on Form 10-K and BridgeBio Pharma's other SEC filings. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

    Roswell Park Contact:

    Annie Deck-Miller

    Ann.Deck-Miller@RoswellPark.org

    716-845-8593

    BridgeBio Contact:

    Grace Rauh

    BridgeBio Pharma, Inc.

    Grace.rauh@bridgebio.com

    (917) 232-5478



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  20. PALO ALTO, Calif., April 13, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) today announced a collaboration with Oregon Health & Science University (OHSU) in Portland, Oregon, to advance research and the development of investigational medicines for patients with genetically driven conditions.

    "We feel privileged to have the opportunity to work with OHSU to focus on developing potential therapies for diseases with clear genetic drivers and severe unmet need," said BridgeBio founder and CEO Neil Kumar, Ph.D. "OHSU was one of the first research institutions we connected with in the early days of BridgeBio, and we look forward to deepening our relationship through close collaboration with their scientists as we strive to help patients…

    PALO ALTO, Calif., April 13, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) today announced a collaboration with Oregon Health & Science University (OHSU) in Portland, Oregon, to advance research and the development of investigational medicines for patients with genetically driven conditions.

    "We feel privileged to have the opportunity to work with OHSU to focus on developing potential therapies for diseases with clear genetic drivers and severe unmet need," said BridgeBio founder and CEO Neil Kumar, Ph.D. "OHSU was one of the first research institutions we connected with in the early days of BridgeBio, and we look forward to deepening our relationship through close collaboration with their scientists as we strive to help patients together."

    This arrangement builds on five years of informal collaborations between the two organizations. Under the agreement, the BridgeBio team will work closely with OHSU scientists and investigators to advance potential medicines for patients with genetically driven conditions, including cancers.

    "BridgeBio's approach to identifying and developing novel therapies allows them to interact with multiple investigators at OHSU who are studying a wide variety of diseases," said OHSU Chief Research Officer and Executive Vice President Peter Barr-Gillespie, Ph.D. "We believe their expertise and infrastructure will help lead to the rapid development of new drugs. We see this collaboration as an important part of our efforts to bring OHSU innovations to clinical significance."

    BridgeBio collaborates with stand-out academic institutions, including OHSU, to support research around genetically driven conditions and is focused on rapidly translating findings into meaningful treatments for patients. Today BridgeBio also announced formal partnerships with Brown University, GlycoNet, The Lundquist Institute, Roswell Park Comprehensive Cancer Center, University of California, Davis and University of California, San Diego – for a total of 20 partnerships between BridgeBio and leading academic and research institutions to date. For a list of some of the institutions BridgeBio partners with, please visit Our Partners page.

    With a diverse pipeline encompassing investigational therapies for rare diseases and genetically validated cancers, BridgeBio provides the insights and support needed to rapidly progress therapeutic research from labs to clinical development. BridgeBio intends to develop similar long-term partnerships based on trust, engagement, science and respect to support its mission of developing life-changing medicines for patients with genetically driven conditions as quickly and safely as possible.

    About BridgeBio Pharma

    BridgeBio is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio's pipeline of over 30 development programs ranges from early science to advanced clinical trials and its commercial organization is focused on delivering the company's first approved therapy. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com.

    BridgeBio Pharma Forward-Looking Statements

    This press release contains forward-looking statements. Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), which are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions.  We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions.  These forward-looking statements, including statements relating to expectations, plans, and prospects regarding our ability to build on the significant advances being made in OHSU's labs and translate them into meaningful medicines for patients in need, the success of current and future relationships with third-party collaborators and academic partners, and the potential ability of our product candidates to treat genetically driven diseases and cancers with clear genetic drivers, reflect our current views about our plans, intentions, expectations, strategies and prospects, and are based on the information currently available to us and on assumptions we have made and are neither forecasts, promises nor guarantees. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by these forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved.  Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, the success of our product candidates to treat genetically driven diseases and cancers with clear genetic drivers, the success of our collaboration with OHSU, as well as those risks set forth in the Risk Factors section of BridgeBio Pharma's most recent Annual Report on Form 10-K and BridgeBio Pharma's other SEC filings. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

    OHSU Contact:

    Erik Robinson

    robineri@ohsu.edu

    (503) 494-8231

    BridgeBio Contact:

    Grace Rauh

    BridgeBio Pharma, Inc.

    Grace.rauh@bridgebio.com

    (917) 232-5478

     



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  21. TORRANCE, Calif. and PALO ALTO, Calif., April 13, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) and The Lundquist Institute for Biomedical Innovation at the Harbor-UCLA Medical Center today announced a collaboration to translate research in genetically driven diseases and cancers into potential treatments for patients.

    "The Lundquist Institute is renowned for its scientific research and drug discoveries, and we look forward to developing a close relationship with their talented scientists in the hope of translating their discoveries into medicines with meaningful benefit for patients," said BridgeBio CEO and Founder Neil Kumar, Ph.D.

    Under the established two-year partnership, BridgeBio will work closely with The Lundquist…

    TORRANCE, Calif. and PALO ALTO, Calif., April 13, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) and The Lundquist Institute for Biomedical Innovation at the Harbor-UCLA Medical Center today announced a collaboration to translate research in genetically driven diseases and cancers into potential treatments for patients.

    "The Lundquist Institute is renowned for its scientific research and drug discoveries, and we look forward to developing a close relationship with their talented scientists in the hope of translating their discoveries into medicines with meaningful benefit for patients," said BridgeBio CEO and Founder Neil Kumar, Ph.D.



    Under the established two-year partnership, BridgeBio will work closely with The Lundquist Institute researchers to identify programs that may have the potential to become therapies for patients with genetically driven conditions and cancers. BridgeBio will potentially sponsor research programs and support the development of Lundquist programs and clinical investigations through its licensing and affiliate development model.

    "By coupling our world-class scientific discoveries with the resources and well-seasoned team at BridgeBio, we have the opportunity to create advancements in therapeutics for genetic diseases," said Rubayath Mohsen, M.S., Manager of Business Development and Technology Transfer from The Lundquist Institute. "Based on their track record in working closely with researchers, we are optimistic about developing our technologies with BridgeBio and look forward to seeing what we can do together to develop new therapeutics for patients in need."

    BridgeBio partners with top academic and research institutions throughout the U.S., including The Lundquist Institute, to support early, promising research in genetically driven diseases and cancers with clear genetic drivers. Today BridgeBio also announced formal partnerships with Brown University, GlycoNet, Oregon Health & Science University, Roswell Park Comprehensive Cancer Center, University of California, Davis and University of California, San Diego – for a total of 20 partnerships between BridgeBio and leading academic and research institutions to date. For a list of some of the institutions BridgeBio is partnered with, please visit Our Partners page.

    With trust, respect and science at the forefront of all collaborations, BridgeBio will continue developing similar long-term partnerships to support its mission of pioneering critical medicines for patients with certain cancers and genetically driven conditions as quickly and safely as possible.

    About The Lundquist Institute: "Research with Reach"™

    The Lundquist Institute is an engine of innovation with a global reach and a 69-year reputation of improving and saving lives. With its new medical research building, its state-of-the-art incubator, "BioLabs at The Lundquist," existing laboratory and support infrastructure, and a 15-acre tech park in the planning stages, the Lundquist Institute serves as a hub for the Los Angeles area's burgeoning biotech scene. The research institute has over 100 principal investigators (PhDs, MDs, and MD/PhDs) working on more than 600 research studies, including therapies for numerous, and often fatal orphan diseases. Find out more at https://lundquist.org.

    About BridgeBio Pharma:

    BridgeBio is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio's pipeline of over 30 development programs ranges from early science to advanced clinical trials and its commercial organization is focused on delivering the company's first approved therapy. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com.

    BridgeBio Pharma Forward-Looking Statements

    This press release contains forward-looking statements. Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), which are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions.  We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions.  These forward-looking statements, including statements relating to expectations, plans, and prospects regarding our ability to build on The Lundquist Institute's scientific innovation and genetic disease research and translate them into meaningful medicines for patients in need, the success of current and future relationships with third-party collaborators and academic partners, and the potential ability of our product candidates to treat genetically driven diseases and cancers with clear genetic drivers, reflect our current views about our plans, intentions, expectations, strategies and prospects, and are based on the information currently available to us and on assumptions we have made and are not forecasts, promises nor guarantees. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by these forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved.  Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, the success of our product candidates to treat genetically driven diseases and cancers with clear genetic drivers, the success of our collaboration with The Lundquist Institute, as well as those risks set forth in the Risk Factors section of BridgeBio Pharma's most recent Annual Report on Form 10-K and BridgeBio Pharma's other SEC filings. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

    The Lundquist Institute Contact:

    Max Benavidez

    The Lundquist Institute

    max.benavidez@lundquist.org

    (310) 200-2682

    BridgeBio Contact:

    Grace Rauh

    BridgeBio Pharma, Inc.

    Grace.rauh@bridgebio.com

    (917) 232-5478



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  22. PALO ALTO, Calif. and EDMONTON, Alberta, April 13, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) and the Canadian Glycomics Network (GlycoNet), a pan-Canadian Network of Centres of Excellence, today announced a collaboration to translate scientific research in glycomics into potential treatments for patients with genetic diseases.

    "We are thrilled to be partnering with GlycoNet, an institution at the forefront of developing carbohydrate-based drugs to address areas of unmet need," said BridgeBio founder and CEO Neil Kumar, Ph.D. "We understand the clinical benefit research in glycomics could have for certain genetic diseases and by partnering together, we hope to advance potentially life-changing medicines as rapidly as possible…

    PALO ALTO, Calif. and EDMONTON, Alberta, April 13, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) and the Canadian Glycomics Network (GlycoNet), a pan-Canadian Network of Centres of Excellence, today announced a collaboration to translate scientific research in glycomics into potential treatments for patients with genetic diseases.

    "We are thrilled to be partnering with GlycoNet, an institution at the forefront of developing carbohydrate-based drugs to address areas of unmet need," said BridgeBio founder and CEO Neil Kumar, Ph.D. "We understand the clinical benefit research in glycomics could have for certain genetic diseases and by partnering together, we hope to advance potentially life-changing medicines as rapidly as possible."

    BridgeBio will work alongside GlycoNet researchers to identify research programs that may have the potential to become treatments for genetic diseases. BridgeBio will potentially sponsor research programs and support clinical investigation through its licensing and affiliate development model. Genetic disease research has benefitted substantially from the study of glycomics, which relates to the functions of glycans, or sugar, in biological systems.

    "The opportunity to partner with BridgeBio is invaluable," said GlycoNet CEO Elizabeth Nanak, Ph.D., MBA. "Our joint effort could potentially address areas of unmet needs and get treatments to patients more efficiently. We are hopeful that our network's expertise in glycomics coupled with BridgeBio's vigor to advance therapies into the clinic, will improve the quality of life of patients with genetic disorders."

    BridgeBio partners with top academic and research institutions throughout the world, including GlycoNet, to support early, promising research. Today BridgeBio also announced formal partnerships with Brown University, The Lundquist Institute, Oregon Health & Science University, Roswell Park Comprehensive Cancer Center, University of California, Davis and University of California, San Diego – for a total of 20 partnerships between BridgeBio and leading academic and research institutions to-date. For a list of some of the institutions BridgeBio is partnered with, please visit Our Partners page.

    As one of its guiding principles for drug development, BridgeBio believes in the importance of developing long-term partnerships through trust, respect and science in order to pioneer critical medicines for patients with genetically driven conditions as quickly and safely as possible.

    About GlycoNet

    GlycoNet is advancing and commercializing innovations in glycomics to improve human health and quality of life. GlycoNet is a one-stop global destination focused on developing new carbohydrate-based drugs, vaccines and diagnostics, in collaboration with academic and industry organizations to address areas of unmet need through applied glycomics research. Funded by the federal Networks of Centres of Excellence (NCE) program and a range of partners, the network includes over 170 researchers across Canada who focus on cancer, chronic diseases, infectious diseases, and neurodegenerative diseases. This national platform supports translational research, protection of intellectual property, novel drug development, company formation and training. For more information, visit GlycoNet.ca.

    About BridgeBio Pharma

    BridgeBio is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio's pipeline of over 30 development programs ranges from early science to advanced clinical trials and its commercial organization is focused on delivering the company's first approved therapy. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information, visit bridgebio.com.

    BridgeBio Pharma Forward-Looking Statements

    This press release contains forward-looking statements. Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), which are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements relating to expectations, plans, and prospects regarding our ability to build on GlycoNet's scientific innovation and genetic disease research and translate them into meaningful medicines for patients in need, the success of current and future relationships with third-party collaborators and academic partners, and the potential ability of our product candidates to treat genetically driven diseases related to glycomics, reflect our current views about our plans, intentions, expectations, strategies and prospects, and are based on the information currently available to us and on assumptions we have made and are not forecasts, promises nor guarantees. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by these forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, the success of our product candidates to treat genetically driven diseases related to glycomics, the success of our collaboration with GlycoNet, as well as those risks set forth in the Risk Factors section of BridgeBio Pharma's most recent Annual Report on Form 10-K and BridgeBio Pharma's other SEC filings. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

    GlycoNet Contact:

    Ali Chou

    GlycoNet

    ychou@glyconet.ca

    (780) 231-5181

    BridgeBio Contact:

    Grace Rauh

    BridgeBio Pharma, Inc.

    Grace.rauh@bridgebio.com

    (917) 232-5478



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  23. PALO ALTO, Calif. and PROVIDENCE, R.I., April 13, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), and Brown University today announced a formal collaboration to advance research in genetically driven neurological disorders into potential life-changing medicines for patients.

    "Brown University is a leader in critical neurology research, and we look forward to partnering with their scientists to focus on discovering and advancing new targeted treatment approaches to potentially address challenging and complex diseases of the brain," said BridgeBio founder and CEO Neil Kumar, Ph.D.

    Under the partnership, BridgeBio will work with scientists at Brown to evaluate new discoveries in neurology research that have promise to advance…

    PALO ALTO, Calif. and PROVIDENCE, R.I., April 13, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), and Brown University today announced a formal collaboration to advance research in genetically driven neurological disorders into potential life-changing medicines for patients.

    "Brown University is a leader in critical neurology research, and we look forward to partnering with their scientists to focus on discovering and advancing new targeted treatment approaches to potentially address challenging and complex diseases of the brain," said BridgeBio founder and CEO Neil Kumar, Ph.D.

    Under the partnership, BridgeBio will work with scientists at Brown to evaluate new discoveries in neurology research that have promise to advance toward clinical investigation. Select therapeutic programs may be spun out and advanced in BridgeBio affiliate companies, with an opportunity for Brown University scientists to support as company leaders and guide ongoing development.

    "BridgeBio's unique approach and support for having researchers stay involved in development made it an easy decision to partner with them in translating our discoveries into potential medicines for patients in need," said Neil Veloso, Executive Director of Brown Technology Innovations at Brown University. "We look forward to the collaboration and empowering Brown faculty to progress their research."

    BridgeBio partners with stand-out academic institutions, including Brown University, to support research around genetically driven conditions and is focused on rapidly translating findings into meaningful treatments for patients. Today BridgeBio also announced formal partnerships with GlycoNet, The Lundquist Institute, Oregon Health & Science University, Roswell Park Comprehensive Cancer Center, University of California, Davis and University of California, San Diego – for a total of 20 partnerships between BridgeBio and leading academic and research institutions to date. For a list of some of the institutions BridgeBio is partnered with, please visit Our Partners page.

    As part of an ongoing effort to translate research in genetically driven conditions toward therapeutic development, BridgeBio will continue to seek long-term partnerships with similar institutions that are rooted in trust, engagement, science and respect in order to drive forward its mission of developing transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers as quickly and safely as possible.

    About Brown University

    Brown University, based in Providence (RI), is a leading research university distinct for its student-centered learning and deep sense of purpose. Its students, faculty and staff are driven by the idea that their work will have an impact in the world. Brown Technology Innovations supports Brown researchers and inventors who seek commercial pathways to broaden the impact of their research.

    About BridgeBio Pharma

    BridgeBio is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio's pipeline of over 30 development programs ranges from early science to advanced clinical trials and its commercial organization is focused on delivering the company's first approved therapy. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com.

    BridgeBio Pharma Forward-Looking Statements

    This press release contains forward-looking statements. Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), which are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions.  We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions.  These forward-looking statements, including statements relating to expectations, plans, and prospects regarding our ability to build on Brown University's scientific innovation and genetic disease research and translate them into meaningful medicines for patients in need, the success of current and future relationships with third-party collaborators and academic partners, and the potential ability of our product candidates to treat genetically driven neurological disorders, reflect our current views about our plans, intentions, expectations, strategies and prospects, and are based on the information currently available to us and on assumptions we have made and are not forecasts, promises nor guarantees. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by these forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved.  Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, the success of our product candidates to treat genetically driven neurological disorders, the success of our collaboration with Brown University, as well as those risks set forth in the Risk Factors section of BridgeBio Pharma's most recent Annual Report on Form 10-K and BridgeBio Pharma's other SEC filings. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

    Brown University Contact:

    Betsy Stubblefield Loucks

    Brown Technology Innovations

    Betsy_Loucks@brown.edu

    401-863-7499

    BridgeBio Contact:

    Grace Rauh

    BridgeBio Pharma, Inc.

    Grace.rauh@bridgebio.com 

    (917) 232-5478

     



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  24. Paul Herzich joins as Chief Technology Officer

    Jared Simons joins as VP of Manufacturing

    AavantiBio, a gene therapy company focused on transforming the lives of patients with rare genetic diseases, today announced new additions to its leadership team with the appointments of Paul Herzich as Chief Technology Officer and Jared Simons as Vice President of Manufacturing. Both Messrs. Herzich and Simons bring significant AAV manufacturing experience to AavantiBio as the Company begins to advance its compelling gene therapy pipeline forward.

    "We are elated to have Paul and Jared join the AavantiBio team as we progress through the strategic planning stages of building out our AAV manufacturing processes with a hyper focus on Chemistry, Manufacturing…

    Paul Herzich joins as Chief Technology Officer

    Jared Simons joins as VP of Manufacturing

    AavantiBio, a gene therapy company focused on transforming the lives of patients with rare genetic diseases, today announced new additions to its leadership team with the appointments of Paul Herzich as Chief Technology Officer and Jared Simons as Vice President of Manufacturing. Both Messrs. Herzich and Simons bring significant AAV manufacturing experience to AavantiBio as the Company begins to advance its compelling gene therapy pipeline forward.

    "We are elated to have Paul and Jared join the AavantiBio team as we progress through the strategic planning stages of building out our AAV manufacturing processes with a hyper focus on Chemistry, Manufacturing and Controls (CMC) execution," said Bo Cumbo, Chief Executive Officer of AavantiBio. "Paul's deep manufacturing expertise and proven track record of advancing INDs into clinical trials, coupled with his experience developing gene therapies, further enhances our capabilities as we look to bring new treatments to life for diseases with significant unmet need."

    Mr. Herzich brings to AavantiBio more than two decades of experience in start-up and commercial manufacturing optimization for biotechnology companies. He also brings significant experience supporting gene therapy INDs as well as other clinical and commercial vaccine programs. Mr. Herzich most recently served as Vice President of CMC at BridgeBio Gene Therapy (NASDAQ:BBIO), where he managed process and analytical development, facilities, quality compliance and cGMP of the company's gene therapy products. Previously, he was Senior Director of Manufacturing at LogicBio (NASDAQ:LOGC), where he established and guided the development of manufacturing processes for the company's platform technology. Prior to LogicBio, Mr. Herzich served as Director of Clinical Gene Therapy Manufacturing at Bamboo Therapeutics, a subsidiary of Pfizer Inc., where he managed facilities, and cGMP manufacturing of the company's gene therapy products. Before that, he served as Head of Technical Development Manufacturing at Seqirus. Mr. Herzich received an MBA from North Carolina State University and a BS in Biology from Rutgers University.

    "I am excited and inspired to be joining a Company that is committed to expanding the field of genetic medicine and delivering potentially transformational gene therapies to patients," said Herzich. "I look forward to working closely with Bo and the team to leverage AavantiBio's strong CMC expertise and put in place the right manufacturing capabilities to enable the Company to advance its innovative pipeline of programs."

    Mr. Simons joins AavantiBio with nearly 20 years of leadership experience in the biotechnology industry, including the development of vaccines and gene therapies as well as building and developing process engineering and validation teams. Previously, he served as Senior Director at Amicus Therapeutics (NASDAQ:FOLD), where he oversaw the product and process lifecycle of the company's late stage clinical and commercial portfolio, including small molecule, biologics, and gene therapy assets. Prior to joining Amicus Therapeutics as a Director in Tech Transfer & Manufacturing Sciences, Mr. Simons was Deputy Director at Sanofi Pasteur where he led the technical transfer of an influenza vaccine drug substance production process into a greenfield 160,000 square foot manufacturing facility. Earlier in his career, he held various positions of increased responsibility at Merck & Co., Inc. (NYSE:MRK). Mr. Simons holds a MS in Chemical Engineering, with a concentration in Biochemical Engineering, and a BS degree in Chemical Engineering both from Drexel University.

    Recently, AavantiBio announced the appointments of Douglas J. Swirsky as Chief Financial Officer and Treasurer, Ty Howton as Chief Operating Officer and General Counsel, and Christopher Wright, M.D., Ph.D., as Chief Medical Officer.

    About AavantiBio, Inc.

    AavantiBio is a gene therapy company backed by a premier syndicate of life sciences investors including Perceptive Advisors, Bain Capital Life Sciences, and RA Capital Management, who led the company's recent $107 million Series A financing. Headquartered in Cambridge, Massachusetts, AavantiBio is advancing a diversified gene therapy pipeline in areas of high unmet medical need, including a lead program in Friedreich's Ataxia (FA), a rare inherited genetic disease that causes cardiac and central nervous system dysfunction. The company benefits from strategic partnerships with the University of Florida's renowned Powell Gene Therapy Center and the MDA Care Center at UF Health where AavantiBio's co-founders and renowned gene therapy researchers Barry Byrne, M.D., Ph.D. and Manuela Corti, P.T., Ph.D maintain their research and clinical practices. Learn more at www.aavantibio.com.

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  25. PALO ALTO, Calif., April 06, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a clinical-stage biopharmaceutical company focused on genetic diseases, today announced that on April 5, 2021, the compensation committee of BridgeBio's board of directors granted 19 new employees restricted stock units for an aggregate of 32,691 shares of the Company's common stock. All of the above-described awards were made under BridgeBio's 2019 Inducement Equity Plan (the Plan).

    The above-described awards were each granted as an inducement material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4), and were granted pursuant to the terms of the Plan. The Plan was adopted by BridgeBio's…

    PALO ALTO, Calif., April 06, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a clinical-stage biopharmaceutical company focused on genetic diseases, today announced that on April 5, 2021, the compensation committee of BridgeBio's board of directors granted 19 new employees restricted stock units for an aggregate of 32,691 shares of the Company's common stock. All of the above-described awards were made under BridgeBio's 2019 Inducement Equity Plan (the Plan).

    The above-described awards were each granted as an inducement material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4), and were granted pursuant to the terms of the Plan. The Plan was adopted by BridgeBio's board of directors in November 2019.

    About BridgeBio

    BridgeBio is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio's pipeline of over 30 development programs ranges from early science to advanced clinical trials and its commercial organization is focused on delivering the Company's first approved therapy. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com.

    Media Contact:

    Grace Rauh

    Grace.rauh@bridgebio.com

    (917) 232-5478

    Source: BridgeBio Pharma, Inc.



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  26. - BridgeBio, through its affiliate QED ("BridgeBio"), and Helsinn to co-commercialize infigratinib for oncology and all other indications other than skeletal dysplasia indications in the U.S. and equally share profits

    - Helsinn Group will have an exclusive license to co-develop, manufacture and commercialize infigratinib in such indications outside of the U.S., excluding China, Hong Kong and Macau

    - BridgeBio will be eligible to receive more than $2 billion USD in upfront, regulatory and commercial milestone payments

    - BridgeBio retains full rights to infigratinib for use in skeletal dysplasias, including for achondroplasia

    PALO ALTO, Calif. and LUGANO, Switzerland, March 31, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO

    - BridgeBio, through its affiliate QED ("BridgeBio"), and Helsinn to co-commercialize infigratinib for oncology and all other indications other than skeletal dysplasia indications in the U.S. and equally share profits

    - Helsinn Group will have an exclusive license to co-develop, manufacture and commercialize infigratinib in such indications outside of the U.S., excluding China, Hong Kong and Macau

    - BridgeBio will be eligible to receive more than $2 billion USD in upfront, regulatory and commercial milestone payments

    - BridgeBio retains full rights to infigratinib for use in skeletal dysplasias, including for achondroplasia

    PALO ALTO, Calif. and LUGANO, Switzerland, March 31, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), through its affiliate QED Therapeutics, Inc., and Helsinn Group today announced a global collaboration and licensing agreement (the "Agreement") to further develop and commercialize QED Therapeutics' FGFR1-3 inhibitor, infigratinib, in oncology and all other indications except for skeletal dysplasias (including achondroplasia). Completion of the Agreement is subject to regulatory review and customary closing conditions, which are expected to occur in the second quarter of 2021.

    Infigratinib is an orally administered, ATP-competitive, tyrosine kinase inhibitor that is designed to inhibit FGFR, and being investigated for treatment of individuals with FGFR-driven conditions, including cholangiocarcinoma (bile duct cancer), urothelial carcinoma (urinary tract and bladder cancer), and other FGFR-driven cancers.

    Under the terms of the Agreement, BridgeBio will retain all rights to infigratinib in skeletal dysplasia, including achondroplasia. Subject to U.S. Food and Drug Administration ("FDA") approval, QED and Helsinn will co-commercialize infigratinib in oncology indications in the U.S. and will share profits and losses on a 50:50 basis. Helsinn will have exclusive commercialization rights and lead commercialization for infigratinib in non-skeletal dysplasia indications outside of the U.S., excluding China, Hong Kong and Macau, which are covered by BridgeBio's strategic development and commercialization collaboration with LianBio. Under the Agreement, BridgeBio will be eligible to receive more than $2 billion in upfront, regulatory and commercial milestones, as well as tiered royalties on adjusted net sales from Helsinn Group.

    "We are privileged to partner with Helsinn as we strive to unlock the full potential of infigratinib for patients with FGFR-driven cancers," said BridgeBio CEO and founder Neil Kumar, Ph.D. "Helsinn has an impressive track record of advancing and commercializing oncology therapies around the globe. Our hope is that partnering with Helsinn will significantly strengthen our anticipated upcoming launch of infigratinib and our ongoing research into infigratinib's potential across other cancer indications."

    Riccardo Braglia, Helsinn Group Vice Chairman and CEO, commented, "As a leader in oncology therapeutics and supportive care, Helsinn is always looking to partner with high quality companies. The combination of BridgeBio and its lead oncology product candidate, infigratinib, fall into the strategic sweet spot of a quality company and product with which we look to work. We are highly excited by the potential positive impact this collaboration can deliver for patients around the world."

    BridgeBio and Helsinn Group intend to pursue an ambitious co-development plan in oncology indications, including clinical investigation underway in first-line cholangiocarcinoma and adjuvant urothelial cancer. This plan will be underpinned by close collaboration among the parties, with the aim of developing new treatments for patients with FGFR-driven cancers. As infigratinib heads toward potential approval and commercialization in a range of oncology indications, Helsinn's unique integrated licensing business model will enable its distribution to reach patients globally.

    The FDA has accepted the New Drug Application ("NDA") for infigratinib for patients with previously-treated advanced cholangiocarcinoma ("CCA") harboring an FGFR2 gene fusion or rearrangement. The NDA has been granted Priority Review designation and is being reviewed under the Real-Time Oncology Review ("RTOR") pilot program, an initiative of the FDA's Oncology Center of Excellence designed to expedite the delivery of safe and effective cancer treatments to patients. Additionally, infigratinib is currently under review in Australia and Canada under Project Orbis, an initiative of the FDA's Oncology Center of Excellence that allows for concurrent submission and review of oncology drugs among participating international regulatory agencies.

    About QED Therapeutics, Inc.

    QED Therapeutics, an affiliate of BridgeBio Pharma, is a biotechnology company focused on precision medicine for FGFR-driven diseases. Its lead investigational candidate is infigratinib (BGJ398), an orally administered, FGFR1-3 selective tyrosine kinase inhibitor that has shown activity that it believes, based on published data to date, to be meaningful in clinical measures, such as overall response rate, in patients with chemotherapy-refractory cholangiocarcinoma with FGFR2 fusions and advanced urothelial carcinoma with FGFR3 genomic alterations. QED submitted a New Drug Application (NDA) with the United States Food and Drug Administration for second- and later-line cholangiocarcinoma in 2020. QED Therapeutics is also evaluating infigratinib in clinical studies for the treatment of achondroplasia. For more information, please visit www.qedtx.com.

    About BridgeBio Pharma, Inc.

    BridgeBio is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio's pipeline of over 30 development programs ranges from early science to advanced clinical trials and its commercial organization is focused on delivering the Company's first approved therapy. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com.

    About Helsinn Group

    Helsinn is a privately-owned Swiss Pharma Company which, since 1976, has been improving the lives of patients, guided by core family values of respect, integrity and quality. The Group has an extensive portfolio of marketed innovative cancer and rare disease therapies, a robust drug development pipeline and ambitions to further accelerate its growth through in-licensing and acquisitions to address unmet medical needs. Helsinn operates a unique integrated licensing business model, achieving success with long-standing partners in 190 countries, who share our values. The Group's pharmaceutical business (Helsinn Healthcare) is headquartered in Lugano, Switzerland with operating subsidiaries in the U.S. (Helsinn Therapeutics US) and China (Helsinn Pharmaceuticals China) which market the Group's products directly in these countries. The Group has additional operating subsidiaries in Switzerland (Helsinn Advanced Synthesis, an active pharmaceutical ingredient manufacturer) and Ireland (Helsinn Birex Pharmaceuticals, a drug product manufacturer). 3B Future Health Fund (formerly known as Helsinn Investment Fund) was created to enhance the future of healthcare by providing funding and strategic support to innovative companies.

    Helsinn Group plays an active and central role in promoting social transformation in favor of people and the environment. Corporate social responsibility is at the heart of everything we do which is reinforced in the company's strategic plan by a commitment to sustainable growth.

    For more information, please visit www.helsinn.com and follow us on Twitter, LinkedIn and Vimeo.

    BridgeBio Pharma Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements include statements relating to expectations, plans and prospects regarding clinical development plans, clinical and therapeutic potential, regulatory status and commercial strategy for infigratinib, including, but not limited to: the successful completion of the global collaboration and licensing agreement between QED Therapeutics, Inc. and Helsinn Group (the Agreement), including regulatory approval of our Hart-Scott-Rodino filing, and the timing thereof; despite having ongoing interactions with the U.S. Food and Drug Administration (FDA) or other regulatory agencies, the FDA or such other regulatory agencies may not agree with BridgeBio's or QED Therapeutics' regulatory approval strategies, components of their filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted for infigratinib for patients with FGFR-driven cancers; the success of and potential synergies from the Agreement and the proposed co-development plan for infigratinib in oncology indications in the United States; the ability of Helsinn Group's unique integrated licensing business model to enable its distribution to reach patients globally; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and the timing of these events, reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to: the design and success of ongoing and planned clinical trials, future regulatory filings, approvals and/or sales; despite having ongoing and future interactions with the FDA or other regulatory agencies to discuss potential paths to registration of infigratinib, the FDA or such other regulatory agencies may not agree with our regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; the successful closing and continuing success of QED Therapeutics' collaboration with Helsinn Group; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those risks set forth in the Risk Factors section of our most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and our other SEC filings. Moreover, BridgeBio and QED Therapeutics operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of BridgeBio's and QED Therapeutics' management as of the date of this release and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we and QED Therapeutics assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

    Contact:

    Grace Rauh

    BridgeBio Pharma, Inc.

    Grace.rauh@bridgebio.com

    (917) 232-5478

    Helsinn Group Media Contact:

    Paola Bonvicini

    Group Head of Communication

    Lugano, Switzerland

    Tel: +41 (0) 91 985 21 21

    Info-hhc@helsinn.com



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  27. – Normalization of Blood Calcium and Urine Calcium in 6 of 6 (100%) Autosomal Dominant Hypocalcemia Type 1 (ADH1) Participants Initially Evaluated Over 5 Days Demonstrates Proof-of-Concept

    – At Doses up to 180 mg Twice Daily, Encaleret was Well-Tolerated with No Serious Adverse Events and No Adverse Events of Moderate or Severe Intensity Reported After 5 Days

    – Company to Host Webcast to Discuss Data on March 22 at 8:00 a.m. ET

    PALO ALTO, Calif., March 20, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a clinical-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, today announced early results from an…

    – Normalization of Blood Calcium and Urine Calcium in 6 of 6 (100%) Autosomal Dominant Hypocalcemia Type 1 (ADH1) Participants Initially Evaluated Over 5 Days Demonstrates Proof-of-Concept

    – At Doses up to 180 mg Twice Daily, Encaleret was Well-Tolerated with No Serious Adverse Events and No Adverse Events of Moderate or Severe Intensity Reported After 5 Days

    – Company to Host Webcast to Discuss Data on March 22 at 8:00 a.m. ET

    PALO ALTO, Calif., March 20, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a clinical-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, today announced early results from an ongoing Phase 2b proof-of-concept, open-label study of encaleret for the treatment of Autosomal Dominant Hypocalcemia Type 1 (ADH1). The data are featured in an ePoster presentation titled ‘The Effects of Encaleret (CLTX-305) on Mineral Physiology in ADH1 Demonstrate Proof-of-Concept: Early Results from an Ongoing Phase 2B, Open-Label, Dose-Ranging Study' at the Endocrine Society's 2021 Annual Meeting (ENDO 2021) taking place virtually from March 20th – 23rd.

    "ADH1 is a rare genetic form of hypoparathyroidism caused by pathogenic variants in the calcium-sensing receptor (CASR) gene that are estimated to be harbored by 12,000 individuals in the United States1. Patients with ADH1 experience a range of symptoms associated with low blood calcium and high urine calcium, which cannot be adequately addressed with current standard of care therapies," said Rachel Gafni, M.D., Senior Research Physician and Head, Mineral Homeostasis Studies Group of the National Institute of Dental and Craniofacial Research, National Institutes of Health (NIH). "In these initial results from the Phase 2b study of encaleret in ADH1, blood and urine calcium levels were normalized in all trial participants within five days of treatment."

    In these data from the ongoing Phase 2b open-label, dose-ranging study, six adults with ADH1 with four distinct CASR genotypes were administered encaleret. Calcitriol (active Vitamin D) therapy (current standard of care) was discontinued prior to and throughout the study. Non-dietary calcium supplements were withheld in five participants with adequate dietary calcium intake. Participants received sequential, increasing daily doses of encaleret starting at 30 mg while undergoing intensive safety monitoring and frequent blood and urine sampling for biochemical measures. Following five days of dosing with encaleret, blood calcium, parathyroid hormone, phosphorus and magnesium were within the normal range on average. Urinary calcium excretion was normal or undetectable in all participants.

    Baseline and day 5 blood and urine calcium levels are summarized in the figure below:

    https://www.globenewswire.com/NewsRoom/AttachmentNg/09f2eee6-0e25-4c52-aa4b-83674ad51af5

    Throughout this initial period of dose escalation, encaleret was well-tolerated with no serious adverse events and no adverse events of moderate or severe intensity reported. Two participants experienced transient, asymptomatic hypophosphatemia which was the only treatment-related adverse event. The tolerability and consistent mineral responses following encaleret administration in all six ADH1 trial participants demonstrates proof of concept that encaleret may be an efficacious therapy option for ADH1.

    The Company intends to meet with regulatory health authorities in 2021 to discuss potential paths to registration prior to initiation of a Phase 3 registrational study in patients with ADH1. If the development program is successful, encaleret could be the first approved therapy option indicated specifically for the treatment of ADH1.

    "A close collaboration between world-leading experts in calcium homeostasis at the National Institute of Dental and Craniofacial Research at the NIH and BridgeBio has made possible the development of encaleret for ADH1," said Jonathan Fox, M.D., Ph.D., Chief Medical Officer of Calcilytix, an affiliate of BridgeBio that is focused on developing encaleret. "We look forward to working with regulators this year to define a potential path to approval for encaleret for the treatment of ADH1 and to exploring its potential use in patients with other forms of hypoparathyroidism."

    At ENDO 2021, BridgeBio also presented clinical study designs for the Phase 2b study of encaleret in ADH1; for its Phase 2 study of low-dose infigratinib, an FGFR1-3 inhibitor, for children with achondroplasia, the most common form of genetic short stature; and for its Phase 1/2 study of its investigational AAV5 gene therapy candidate for congenital adrenal hyperplasia (CAH). CAH is one of the most prevalent genetic diseases that could potentially be addressable with AAV gene therapy.

    1 Dershem et al., Amer Jour of Hum Genetics, 2020

    Webcast Information

    BridgeBio will host a conference call and simultaneous webcast to share updates on the encaleret proof-of-concept data in ADH1 on March 22 at 8:00 a.m. ET. To access this call, dial (800) 379-2666 (U.S.) or (409) 937-8964 (International). Conference ID: 7371879. A link to the webcast may be accessed from the event calendar page of BridgeBio's website at https://investor.bridgebio.com/. A replay of the conference call and webcast will be archived on the Company's website and will be available for at least 30 days following the event. 

    About BridgeBio Pharma, Inc.

    BridgeBio is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio's pipeline of over 30 development programs ranges from early science to advanced clinical trials and its commercial organization is focused on delivering the company's first approved therapy. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com.

    BridgeBio Pharma Forward-Looking Statements

    This press release contains forward-looking statements. Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements relating to expectations, plans and prospects regarding the preclinical and clinical development plans, clinical trial designs, clinical and therapeutic potential, and strategy of our product candidates, including, but not limited to: the unknown future impact of the COVID-19 pandemic delay on our ongoing clinical trials and/or our operations or operating expenses; early results from our ongoing Phase 2b proof-of-concept, open-label study of encaleret for the treatment of Autosomal Dominant Hypocalcemia Type 1 (ADH1) being indicative of final data from our Phase 2b study of encaleret; the potential size of the target patient population with a rare genetic form of hypoparathyroidism caused by pathogenic variants in the calcium-sensing receptor (CASR) gene; the inability of current standard of care therapies to treat ADH1; encaleret continuing to be well-tolerated with no serious adverse events and no adverse events of moderate or severe intensity reported in our ongoing Phase 2b proof-of concept, open-label study; tolerability and consistent mineral responses following encaleret administration in all six ADH1 trial participants continuing to demonstrate proof-of-concept that encaleret may be an efficacious therapy option for ADH1; the timing and success of our planned meetings with regulatory health authorities, including the U.S. Food and Drug Administration (FDA), in 2021 to discuss potential paths to registration prior to initiation of a Phase 3 registrational study in patients with ADH1; the ability of encaleret to be the first approved therapy option indicated specifically for the treatment of ADH1, if the development program is successful; the continuing close collaboration between world-leading experts in calcium homeostasis at the National Institute of Dental and Craniofacial Research at the National Institutes of Health and BridgeBio; the exploration of encaleret's potential use in patients with other forms of hypoparathyroidism; the clinical study designs for our Phase 2b study of encaleret in ADH1, for our Phase 2 study of low-dose infigratinib, an FGFR1-3 inhibitor for children with achondroplasia, and for our Phase 1/2 study of our investigational AAV5 gene therapy candidate for Congenital Adrenal Hyperplasia (CAH); CAH being one of the most prevalent genetic diseases that could potentially be addressable with AAV gene therapy;; and the timing of these events, reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to: early data from our ongoing Phase 2b proof-of-concept, open-label study of encaleret for the treatment of ADH1 not being indicative of final data; the potential size of the target patient population for ADH1 not being as large as anticipated; encaleret not being well-tolerated, with serious adverse events and adverse events of moderate or severe intensity being reported in the final Phase 2b study data; encaleret not continuing to demonstrate that it may be an efficacious therapy option for ADH1 based on the final Phase 2b data; encaleret not being the first approved therapy option indicated specifically for the treatment of ADH1, if the development program is not successful or if a competing therapy option is approved; the design and success of ongoing and planned clinical trials, future regulatory filings, approvals and/or sales; despite having ongoing and future interactions with the FDA or other regulatory agencies to discuss potential paths to registration prior to initiation of a Phase 3 registrational study of encaleret in patients with ADH1, the FDA or such other regulatory agencies may not agree with our regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; the continuing success of our close collaboration between the National Institute of Dental and Craniofacial Research at the National Institutes of Health; the inability of encaleret to be used in patients with other forms of hypoparathyroidism; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those risks set forth in the Risk Factors section of our most recent quarterly or annual periodic report filed with the U.S. Securities and Exchange Commission (SEC) and our other SEC filings. Moreover, BridgeBio operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of BridgeBio's management as of the date of this release and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

    BridgeBio Contact:

    Grace Rauh

    BridgeBio Pharma, Inc.

    Grace.rauh@bridgebio.com

    (917) 232-5478

     



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  28. PALO ALTO, Calif., March 02, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a clinical-stage biopharmaceutical company focused on genetic diseases, today announced that on March 1, 2021, the compensation committee of BridgeBio's board of directors granted 17 new employees restricted stock units for an aggregate of 30,510 shares of the Company's common stock. All of the above-described awards were made under BridgeBio's 2019 Inducement Equity Plan (the Plan).

    The above-described awards were each granted as an inducement material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4), and were granted pursuant to the terms of the Plan. The Plan was adopted by BridgeBio's…

    PALO ALTO, Calif., March 02, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a clinical-stage biopharmaceutical company focused on genetic diseases, today announced that on March 1, 2021, the compensation committee of BridgeBio's board of directors granted 17 new employees restricted stock units for an aggregate of 30,510 shares of the Company's common stock. All of the above-described awards were made under BridgeBio's 2019 Inducement Equity Plan (the Plan).

    The above-described awards were each granted as an inducement material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4), and were granted pursuant to the terms of the Plan. The Plan was adopted by BridgeBio's board of directors in November 2019.

    About BridgeBio

    BridgeBio is a team of experienced drug discoverers, developers and innovators working to create life-altering medicines that target well-characterized genetic diseases at their source. BridgeBio was founded in 2015 to identify and advance transformative medicines to treat patients who suffer from Mendelian diseases, which are diseases that arise from defects in a single gene, and cancers with clear genetic drivers. BridgeBio's pipeline of over 30 development programs includes product candidates ranging from early discovery to late-stage development. For more information visit bridgebio.com.

    Media Contact:

    Grace Rauh

    Grace.rauh@bridgebio.com

    (917) 232-5478

    Source: BridgeBio Pharma, Inc.



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  29. Molybdenum cofactor deficiency (MoCD) Type A, an ultra-rare, life-threatening genetic disorder that progresses rapidly, results in severe and largely irreversible neurological injury, and has a high infant mortality rate; median overall survival age is about four years

    Clinical trials with NULIBRY or recombinant cPMP showed a meaningful increase in overall survival compared to a natural history study

    NULIBRY is BridgeBio's first FDA-approved therapeutic

    PALO ALTO, Calif., Feb. 28, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) (BridgeBio) and affiliate Origin Biosciences, Inc. (Origin) today announced the U.S. Food and Drug Administration (FDA) has approved NULIBRY™ (fosdenopterin) for Injection as the first therapy to reduce…

    Molybdenum cofactor deficiency (MoCD) Type A, an ultra-rare, life-threatening genetic disorder that progresses rapidly, results in severe and largely irreversible neurological injury, and has a high infant mortality rate; median overall survival age is about four years

    Clinical trials with NULIBRY or recombinant cPMP showed a meaningful increase in overall survival compared to a natural history study

    NULIBRY is BridgeBio's first FDA-approved therapeutic

    PALO ALTO, Calif., Feb. 28, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) (BridgeBio) and affiliate Origin Biosciences, Inc. (Origin) today announced the U.S. Food and Drug Administration (FDA) has approved NULIBRY™ (fosdenopterin) for Injection as the first therapy to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A. This is the first therapy of its kind. The novel therapy was developed based on BridgeBio's commitment to developing a treatment for MoCD Type A in collaboration with the experts and families in the MoCD Type A community. The announcement was made on Rare Disease Day, which aims to raise awareness about the impact of rare diseases on patients.

    MoCD Type A is an ultra-rare and progressive condition, known to impact less than 150 patients globally with a median survival of four years. MoCD Type A presents shortly after birth, often with severe encephalopathy and intractable seizures. NULIBRY is a first-in-class approved cPMP substrate replacement therapy.

    "The FDA's approval of NULIBRY means that patients with MoCD Type A and their families have an approved therapy for the first time. It also reflects our belief that every life matters and that no disease is too rare to address. As is often true in rare disease drug development, this was a community effort in which we were able to play a part – we'd like to thank the patients, caregivers, physicians, scientists, and advocates who played an essential role in achieving this important milestone," said BridgeBio founder and CEO Neil Kumar, Ph.D.

    The efficacy of NULIBRY for the treatment of patients with MoCD Type A was established based on data from three clinical trials compared to data from a natural history study. In these studies, NULIBRY or recombinant cPMP (rcPMP; same active moiety and biologic activity as NULIBRY) reduced the risk of death by 82% compared to the untreated, genotype-matched, historical control group in the natural history study (HR=0.18, 95% CI 0.04, 0.72). At three years on study, the probability of survival in NULIBRY or rcPMP-treated patients (n=13) was 84% (95% CI 49%,96%) compared to 55% (95% CI 30%,74%) for untreated genotype-matched patients in the historical control group (n=18) at three years (Figure 1). In addition to the survival analysis, treatment with NULIBRY led to a reduction of urine concentrations of S-sulfocysteine (SSC), a toxic substance that leads to neurological damage, in patients with MoCD Type A, and the reduction was sustained with long-term treatment over 48 months.

    Animal studies have identified that NULIBRY has phototoxic potential. In the clinical trials, the most common adverse reactions reported in two or more Nulibry-treated patients with MoCD Type A were catheter-related complications (89%), pyrexia (fever; 78%), viral infection (56%), pneumonia (44%), otitis media (ear infection; 44%), vomiting (44%) and cough/sneezing (44%). Adverse reactions for the rcPMP-treated patients were similar to the NULIBRY-treated patients.

    "Today's approval represents new hope for patients and families affected with MoCD Type A," said Donald Basel, M.D., section chief and associate professor of pediatrics at Children's Wisconsin. "I am encouraged by the clinical data showing that NULIBRY not only lowers the levels of toxic SSC, but importantly extends the lives of patients who previously had only a three- to four-year median survival."

    NULIBRY was reviewed under Priority Review and received Orphan Drug Designation, Breakthrough Therapy Designation and Rare Pediatric Disease Designation from the FDA. With this approval, the FDA also issued a Rare Pediatric Disease Priority Review Voucher (PRV) to Origin.

    BridgeBio and Origin are committed to patient access and have developed a comprehensive patient support program, ForgingBridges, to help patients access NULIBRY. ForgingBridges also provides tools and resources to help patients and caregivers throughout their treatment journey with NULIBRY.

    Visit NULIBRY.com for more information, including full Prescribing Information.

    About Molybdenum Cofactor Deficiency (MoCD) Type A

    MoCD Type A is an autosomal recessive, inborn error of metabolism caused by mutations in the molybdenum cofactor synthesis 1 gene (MOCS1) and characterized by a deficiency in molybdenum cofactor (MoCo) production, leading to a lack of molybdenum-dependent enzyme activity1,2. The lack of activity leads to decreased sulfite oxidase activity with buildup of sulfite and secondary metabolites (such as S-sulfocysteine (SSC)) in the brain, which causes irreversible neurological damage.2

    MoCD Type A is an ultra-rare disease. The incidence and prevalence of MoCD Type A in the United States are not known, but the estimated incidence is 1 per 342,000 to 411,000 live births (0.24 and 0.29 per 100,000).3 Based on these estimates, MoCD Type A is likely to be underdiagnosed, with an estimated 22 to 26 missed diagnoses per year in the United States and European Union.

    The most common presenting symptoms of MoCD Type A are seizures, feeding difficulties and encephalopathy. Patients with MoCD Type A who survive beyond infancy typically suffer from progressive brain damage, which presents in characteristic patterns on magnetic resonance imaging (MRI). This damage leads to severe psychomotor impairment and an inability to make coordinated movements or communicate with their environment.

    About NULIBRY (fosdenopterin) for Injection

    NULIBRY (fosdenopterin) for Injection is a substrate replacement therapy that provides an exogenous source of cPMP, which is converted to molybdopterin. Molybdopterin is then converted to molybdenum cofactor, which is needed for the activation of molybdenum-dependent enzymes, including sulfite oxidase, an enzyme that reduces levels of neurotoxic sulfites. It is the first and only FDA-approved therapy indicated to reduce the risk of mortality in patients with MoCD Type A, and clinical trials have demonstrated that patients treated with NULIBRY or rcPMP had an improvement in overall survival compared to the untreated, genotype-matched, historical control group.

    IMPORTANT SAFETY INFORMATION

    WARNINGS AND PRECAUTIONS

    Potential for Photosensitivity

    NULIBRY can make the patient oversensitive to sunlight. NULIBRY-treated patients or their caregivers are advised to avoid or minimize patient exposure to sunlight and artificial UV light and adopt precautionary measures when exposed to the sun, including wearing protective clothing and sunglasses, and use broad-spectrum sunscreen with high SPF in patients 6 months of age and older. If photosensitivity occurs, caregivers/patients are advised to seek medical attention immediately and consider a dermatological evaluation.

    ADVERSE REACTIONS

    The most common adverse reactions in NULIBRY-treated patients were infusion catheter–related complications (89%), pyrexia (fever) (78%), viral infection (56%), pneumonia (44%), otitis media (ear infection) (44%), vomiting (44%), and cough/sneezing (44%). Adverse reactions for rcPMP-treated patients were similar to the NULIBRY-treated patients.

    PATIENT COUNSELING INFORMATION

    Please read the FDA-approved NULIBRY Prescribing Information and Instructions for Use and follow the instructions on how to prepare and administer NULIBRY.

    NULIBRY has a potential for photosensitivity; see Warnings and Precautions. Seek medical attention immediately if the patient develops a rash or if they notice symptoms of photosensitivity reactions (redness, burning sensation of the skin, blisters).

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

    Clinical Trials4

    The efficacy of NULIBRY for the treatment of patients with MoCD Type A was established based on data from three clinical trials compared to data from a natural history study.

    Study 1: Study 1 was a prospective, open-label, single-arm, dose-escalation study in patients with MoCD Type A who were receiving treatment with rcPMP prior to treatment with NULIBRY. Study 1 included eight patients, six of whom previously participated in Study 3. The initial NULIBRY dosage was matched to the patient's rcPMP dosage upon entering the study. The NULIBRY dosage was then titrated over a period of five months to a maximum dosage of 0.9 mg/kg administered once daily as an intravenous infusion.

    Study 2: Study 2 was a prospective, open-label, single-arm, dose-escalation study in one patient with confirmed MoCD Type A who had not been previously treated with rcPMP. The initial dosage of NULIBRY in Study 2 was based on the gestational age of the patient (i.e., 36 weeks). The initial dosage was then incrementally escalated up to a maximum dosage of 0.98 mg/kg administered once daily as an intravenous infusion (1.1 times the maximum approved recommended dosage).

    Study 3: Study 3 was a retrospective, observational study that included 10 patients with a confirmed diagnosis of MoCD Type A who received rcPMP. Six of these 10 patients were later enrolled in Study 1 to receive treatment with NULIBRY.

    NULIBRY Efficacy and Safety Data4

    The efficacy of NULIBRY and rcPMP were assessed in a combined analysis of the 13 patients with genetically confirmed MoCD Type A from Study 1 (n=8), Study 2 (n=1), and Study 3 (n=4), who received substrate replacement therapy with NULIBRY or rcPMP.

    Of the 13 treated patients included in the combined analysis, 54% were male, 77% were White and 23% were Asian; the median gestational age was 39 weeks (range 35 to 41 weeks). Of these 13 treated patients, the age at first dose was ≤ 14 days for 10 patients (with five patients initiating treatment at one day of age) and ≥32 days and <69 days for the remaining three patients.

    Efficacy was assessed by comparing overall survival in pediatric patients treated with NULIBRY or rcPMP (n=13) with an untreated natural history cohort of pediatric patients with genetically confirmed MoCD Type A who were genotype-matched to the treated patients (n=18). Patients treated with NULIBRY or rcPMP had an improvement in overall survival compared to the untreated, genotype-matched, historical control group. Results were similar when comparing treated patients with all patients in the untreated natural history cohort with genetically confirmed MoCD Type A (n=37, including the 18 genotype-matched untreated patients as well as 19 additional untreated patients who were not genotype-matched).

    Treatment with NULIBRY resulted in a reduction of urine concentrations of SSC in patients with MoCD Type A, and the reduction was sustained with long-term treatment over 48 months. The baseline level of urinary SSC normalized to creatinine was characterized in one patient (Study 2) with a value of 89.8 umol/mmol. Following treatment with NULIBRY in Studies 1 and 2 (n=9), the mean±SD levels of urinary SSC normalized to creatinine ranged from 11 (±8.5) to 7 (±2.4) umol/mmol from month 3 to month 48.

    The safety of NULIBRY was assessed in 37 pediatric patients and healthy adults who received at least one intravenous infusion of NULIBRY or rcPMP. Of these 37 patients/healthy adults, 13 were pediatric patients with MoCD Type A in Studies 1, 2 and 3; six were pediatric patients with presumptive MoCD Type A but who were later confirmed to not have MoCD type A; and 18 were healthy adults (without MoCD Type A) in a Phase 1 study.  

    The most common adverse reactions from NULIBRY-treated patients in Studies 1 and 2 were catheter-related complications, pyrexia (fever), viral infection, pneumonia, otitis media (ear infection), vomiting and cough/sneezing. Adverse reactions for the rcPMP-treated patients from Study 3 were similar to the NULIBRY-treated patients, with the exception of the following additional adverse reactions that were reported in more than one patient: sepsis, oral candidiasis, varicella, fungal skin infection and eczema.

    About Origin Biosciences, Inc.

    Origin Biosciences, Inc., an affiliate of BridgeBio Pharma, Inc., is a biotechnology company that developed and commercialized NULIBRY for the treatment of patients with a diagnosis or presumptive diagnosis of MoCD Type A. Origin Biosciences, Inc. is led by a team of veteran biotechnology executives. For more information on Origin Biosciences, Inc., please visit the company's website at www.origintx.com.

    About BridgeBio Pharma, Inc.

    BridgeBio is a team of experienced drug discoverers, developers and innovators working to create life-altering medicines that target well-characterized genetic diseases at their source. BridgeBio was founded in 2015 to identify and advance transformative medicines to treat patients who suffer from Mendelian diseases, which are diseases that arise from defects in a single gene, and cancers with clear genetic drivers. BridgeBio's pipeline of over 30 development programs includes product candidates ranging from early discovery to late-stage development. For more information visit bridgebio.com.

    BridgeBio Pharma Forward-Looking Statements

    This press release contains forward-looking statements. Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act, and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements relating to: the development by Origin Biosciences, Inc. (Origin) of NULIBRY™ (fosdenopterin) for Injection as the first therapy approved by the U.S. Food and Drug Administration (FDA) to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A; the potential for NULIBRY as the first and only FDA approved therapy for MoCD Type A; the efficacy of NULIBRY for the treatment of patients with MoCD Type A; the safety profile of NULIBRY for the treatment of patients with MoCD Type A, including the most common adverse reactions; BridgeBio's belief that every life matters and that no disease is too rare to address; the potential for NULIBRY to lower the levels of toxic S-sulfocysteine (SSC) and extend the lives of treated patients; the ability of NULIBRY to retain Orphan Drug Designation, Breakthrough Therapy Designation and Rare Pediatric Disease Designation from the FDA; the ability of ForgingBridges to be a comprehensive patient support program and help patients access NULIBRY; plans for the supply, manufacturing and distribution of NULIBRY; the incidence and prevalence of MoCD Type A; the current FDA-approved NULIBRY Prescribing Information and Instructions for Use; the planned approval of NULIBRY by foreign regulatory authorities and the necessary clinical trial results, and timing and completion of regulatory submissions related thereto; and the competitive environment and clinical and therapeutic potential of NULIBRY, reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation: the fact that there has never been an approved therapy for MoCD Type A; the safety, tolerability and efficacy profile of NULIBRY observed to date may change adversely in ongoing analyses of trial data or subsequent to commercialization; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with Origin's regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; Origin may encounter delays in meeting manufacturing or supply timelines or disruptions in its distribution plans for NULIBRY; whether and when any regulatory submissions may be filed in various foreign jurisdictions and ultimately approved by foreign regulatory authorities; and potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; as well as those set forth in the Risk Factors section of BridgeBio Pharma, Inc.'s most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent SEC filings, which are available on the SEC's website at www.sec.gov. Except as required by law, each of BridgeBio and Origin disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. Moreover, BridgeBio and Origin operate in a very competitive environment in which new risks emerge from time to time. These forward-looking statements are based on each of BridgeBio's and Origin's current expectations, and speak only as of the date hereof.

    References

    1Mechler K et al. Genet Med. 2015;17(12):965-970.

    2Schwarz G. Cur Op in Che Bio. 2016;31:179-187.

    3Mayr SJ, et al. Forecasting the incidence of rare diseases: an iterative computational and biochemical approach in molybdenum cofactor deficiency type A. Presented at the 2019 SSIEM meeting; September 3-6, 2019; Rotterdam, The Netherlands.

    4NULIBRY (fosdenopterin) Origin Biosciences, Palo Alto, CA, USA; February 2021.

    NOTE: NULIBRY is a trademark of Origin Biosciences, Inc. Origin Biosciences, Inc. is a member of the BridgeBio family. ForgingBridges is a trademark of BridgeBio.

    Contact:

    Grace Rauh

    grace.rauh@bridgebio.com

    (917) 232-5478

    Source: BridgeBio Pharma, Inc.

    A Media Snippet accompanying this announcement is available by clicking on the image or link below:



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  30. Completed acquisition of Eidos Therapeutics, allowing BridgeBio to deploy its full clinical and commercial infrastructure to develop and plan for potential global commercialization upon regulatory approval of Eidos' product candidate, acoramidis, a potential best-in-class therapy for patients with amyloidosis cardiomyopathy (ATTR-CM)

    New Drug Application (NDA) for infigratinib for the treatment of cholangiocarcinoma accepted by the U.S. Food and Drug Administration (FDA) under Priority Review designation and Real-Time Oncology Review (RTOR) pilot program, designed to expedite the delivery of safe and effective cancer treatments to patients

    Initiated two new clinical trials since last quarterly update and progressed additional 17 ongoing

    Completed acquisition of Eidos Therapeutics, allowing BridgeBio to deploy its full clinical and commercial infrastructure to develop and plan for potential global commercialization upon regulatory approval of Eidos' product candidate, acoramidis, a potential best-in-class therapy for patients with amyloidosis cardiomyopathy (ATTR-CM)

    New Drug Application (NDA) for infigratinib for the treatment of cholangiocarcinoma accepted by the U.S. Food and Drug Administration (FDA) under Priority Review designation and Real-Time Oncology Review (RTOR) pilot program, designed to expedite the delivery of safe and effective cancer treatments to patients

    Initiated two new clinical trials since last quarterly update and progressed additional 17 ongoing clinical trials

    Ended quarter with $607.1 million in cash, cash equivalents and marketable securities before issuance of 2.25% Convertible Senior Notes in February 2021, which raised nearly $750 million in gross proceeds

    PALO ALTO, Calif., Feb. 25, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) (BridgeBio or the Company), a clinical-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, today reported its financial results for the fourth quarter and full year ended December 31, 2020 and provided an update on the Company's operations.

    Since its last quarterly update, BridgeBio completed its acquisition of Eidos Therapeutics, Inc. (NASDAQ:EIDX) (Eidos) in January 2021, acquiring all of the outstanding shares of Eidos common stock that BridgeBio did not already own. The merger returns BridgeBio and Eidos to a single unified company and is intended to allow BridgeBio to unlock the full potential of acoramidis, a potential best-in-class therapy for patients with transthyretin (TTR) amyloidosis (ATTR). 

    Acoramidis for ATTR is one of BridgeBio's four core value driver programs along with encaleret (CaSR inhibitor) for autosomal dominant hypocalcemia type 1 (ADH1), low-dose infigratinib (FGFR inhibitor) for achondroplasia, and BBP-631, an AAV5 gene therapy for congenital adrenal hyperplasia (CAH). Pivotal or potential proof-of-concept data is anticipated for each of the programs by the end of 2021 or early 2022.

    BridgeBio had its second NDA accepted by the FDA and is preparing for its first two commercial launches this year, pending FDA approval, for infigratinib for the treatment of cholangiocarcinoma (CCA), or bile duct cancer, as a second-line or later therapy in patients with advanced and/or metastatic CCA with FGFR2 fusions or translocations, and for fosdenopterin for the treatment of MoCD Type A, an ultra-rare, life-threatening genetic disorder that results in severe and largely irreversible neurological injury for infants and children. Additionally, the Company initiated two new clinical trials and progressed 17 additional ongoing trials. BridgeBio established a joint venture with Maze Therapeutics to advance precision medicine to treat cardiovascular disease and entered into a partnership agreement with the University of California, San Francisco to drive the advancement of academic innovations in genetically driven diseases into potential therapeutics for patients.

    "We are hopeful that the scientific innovation we are pursuing at scale begins to translate into meaningful gains for patients this year. We are on track to deliver near-term pivotal or potential proof-of-concept data in our four core value driver programs. The successful completion of our acquisition of Eidos allows us to further focus BridgeBio's clinical and commercialization engine on acoramidis for patients suffering from ATTR," said BridgeBio CEO and founder, Neil Kumar, Ph.D. "We are also starting the year in a strong financial position following our recent debt financing, which enables us to progress the 19 ongoing clinical trials and over 30 programs in our pipeline, as well as to prepare for the anticipated launch of our first two drugs, if approved."

    Major milestones anticipated in 2021 or early 2022 for BridgeBio's four core value drivers:

    • Acoramidis (AG10) – TTR stabilizer for ATTR-CM: Topline results from Part A of the ATTRibute-CM trial are expected in late 2021 or early 2022 and from Part B in 2023. If Part A is successful, BridgeBio expects to submit an application for regulatory approval of acoramidis in 2022. ATTR is a form of amyloidosis caused by the accumulation of misfolded TTR protein. It is estimated to affect more than 400,000 people in the United States and the European Union and is largely undiagnosed today.



    • Encaleret – calcium-sensing receptor (CaSR) inhibitor for ADH1: Early results from an ongoing Phase 2 proof-of-concept study will be shared at the Endocrine Society's 2021 Annual Meeting (ENDO) on March 20th. If the development program is successful, encaleret could be the first approved therapy for ADH1, a condition caused by gain of function variants in the CaSR gene estimated to be carried by 12,000 individuals in the United States alone.



    • Low-dose infigratinib – FGFR1-3 inhibitor for achondroplasia: Initial data from the ongoing Phase 2 dose ranging study are expected in the second half of 2021. Achondroplasia is the most common form of genetic short stature and one of the most common genetic diseases, with 55,000 cases in the United States and European Union. Low-dose infigratinib is the only known product candidate in development for achondroplasia that targets the disease at its genetic source and the only orally administered product candidate in clinical-stage development.



    • BBP-631 – AAV5 gene therapy candidate for CAH: Initiation of a first-in-human Phase 1/2 study is expected in the second half of 2021, with initial data anticipated in late 2021 or early 2022. CAH is one of the most prevalent genetic diseases potentially addressable with AAV gene therapy, with more than 75,000 cases in the United States and European Union. The disease is caused by deleterious mutations in the gene encoding an enzyme called 21-hydroxylase, leading to lack of endogenous cortisol production. BridgeBio's AAV5 gene therapy candidate is designed to provide a functional copy of the 21-hydroxylase-encoding gene (CYP21A2) and potentially address many aspects of the disease course.

    Recent pipeline progress and corporate updates:

    • Completed acquisition of Eidos Therapeutics in January 2021, acquiring of all of the outstanding shares of Eidos common stock that BridgeBio did not already own. The merger returns Eidos to BridgeBio's vibrant ecosystem of innovation and is intended to allow BridgeBio to deploy its full clinical and commercial infrastructure to support the development and global commercialization plans underway for Eidos' product candidate, acoramidis, a potential best-in-class therapy for patients with ATTR-CM.



    • Raised nearly $750 million in gross proceeds in February 2021 through issuance of 2.25% Convertible Senior Notes due in 2029. The Company expects current cash, cash equivalents and marketable securities to support its planned operations into 2023.



    • NDA accepted by the FDA for infigratinib, an oral FGFR1-3 selective inhibitor, for individuals with CCA as a second-line or later therapy in patients with advanced and/or metastatic CCA with FGFR2 fusions or translocations. The NDA has been granted Priority Review designation and is being reviewed under the Real-Time Oncology Review (RTOR) pilot program. BridgeBio has also submitted for regulatory review in Australia and Canada under Project Orbis, an initiative of the FDA's Oncology Center of Excellence that allows for concurrent submission and review of oncology drugs among participating international regulatory agencies.



    • BBP-681 - Topical PI3Ka inhibitor for venous malformations (VMs), lymphatic malformations (LMs), and venolymphatic malformations (VLMs) associated with PIK3CA or TEK mutations: Dosed first patient in Phase 1/2 clinical trial.



    • BBP-398 – SHP2 inhibitor for tumors driven by RAS and receptor tyrosine kinase mutations: Dosed first patient in Phase 1 clinical trial.



    • Established Contour Therapeutics, a joint venture between BridgeBio and Maze Therapeutics, focused on transforming and advancing breakthrough precision medicine approaches designed to treat cardiovascular disease, the leading cause of death worldwide.



    • Established collaboration agreement with the University of California, San Francisco to advance the discovery of therapies for genetically driven diseases.

    Fourth Quarter and Full-Year 2020 Financial Results:

    Cash, Cash Equivalents and Marketable Securities

    Cash, cash equivalents and marketable securities, excluding restricted cash, totaled $607.1 million as of December 31, 2020, compared to $577.1 million as of December 31, 2019. The net increase in cash balance of $30.0 million reflects $537.0 million in net proceeds received from the issuance of our 2.50% Convertible Senior Notes due 2027 (2027 Notes), $24.1 million in net proceeds received from Eidos' at-the-market issuance of shares, offset by payment of $75.0 million to repurchase BridgeBio shares in capped call transactions in connection with the issuance of our 2027 Notes, $49.3 million payment related to capped call option, $15.3 million payments of interest on our debts, and $391.5 million primarily related to operating expenses. 

    Cash, cash equivalents and marketable securities, excluding restricted cash, totaled $710.7 million as of September 30, 2020, resulting in a decrease of $103.6 million as compared to December 31, 2020. The decrease in cash reflects $2.0 million payments of interests on our debts and $109.6 million primarily relating to operating expenses, partially offset by a receipt of $8.0 million in upfront payment under the license agreement with LianBio.

    Operating Expenses

    Operating expenses for the three months and year ended December 31, 2020 were $127.6 million and $482.7 million, respectively, as compared to $92.5 million and $306.8 million, respectively, for the same periods in the prior year. The increases in operating expenses of $35.1 million and $175.9 million during the respective periods were attributable to the increase in external-related costs, including manufacturing validation activities for our late-stage programs, and increase in personnel costs resulting from an increase in the number of employees to support the progression in our research and development programs, including our increasing research pipelines, and overall growth of our operations.

    Operating expenses for the three months ended December 31, 2020 decreased by $0.5 million when compared to the operating expenses for the three months ended September 30, 2020 of $128.1 million.

    Our research and development expenses have not been significantly impacted by the global outbreak of COVID-19 for the periods presented. While we experienced some delays in certain of our clinical enrollment and trial commencement activities, we continue to adapt in this unprecedented time to enable alternative site, telehealth and home visits, at-home drug delivery, as well as mitigation strategies with our contract manufacturing organizations. The longer-term impact of COVID-19 on our operating expenses is currently unknown.



    BRIDGEBIO PHARMA, INC.
    Condensed Consolidated Statements of Operations
    (in thousands, except shares and per share amounts)
     
     Three Months Ended December 31, Year Ended December 31,
     2020 2019 2020 2019
            
          
     (Unaudited) (Unaudited) (1)
    License revenue$122 $13,819 $8,249 $40,560
    Operating expenses:       
    Cost of license revenue   2,500
    Research and development90,174 57,485 337,047 209,947
    General and administrative37,437 34,972 145,684 94,353
    Total operating expenses127,611 92,457 482,731 306,800
    Loss from operations(127,489) (78,638) (474,482) (266,240)
    Other income (expense), net:       
    Interest income448 2,410 4,015 8,915
    Interest expense(10,962) (3,040) (36,655) (8,765)
    Share in net loss of equity method investments (4,725)  (20,869)
    Other income (expense)2,978 (158) 1,634 (1,626)
    Total other income (expense), net(7,536) (5,513) (31,006) (22,345)
    Net loss(135,025) (84,151) (505,488) (288,585)
    Net loss attributable to redeemable convertible noncontrolling interests and noncontrolling interests15,044 10,693 56,764 27,998
    Net loss attributable to common Stockholders of BridgeBio$(119,981) $(73,458) $(448,724) $(260,587)
    Net loss per share, basic and diluted$(1.01) $(0.62) $(3.80) $(2.48)
    Weighted-average shares used in computing net loss per share, basic and diluted118,985,489 117,691,534 117,995,457 105,099,089











    BRIDGEBIO PHARMA, INC.
    Condensed Consolidated Balance Sheets
    (In thousands)
     
     December 31,
     2020 2019
    Assets(Unaudited)  (1)
    Cash and cash equivalents and marketable securities (2)$607,093 $577,137
    Receivable from a related party 2,845
    Prepaid expenses and other current assets35,731 19,784
    Property and equipment, net20,325 5,625
    Operating lease right-of-use assets16,508 
    Other assets23,931 26,288
    Total assets$703,588 $631,679
    Liabilities, Redeemable Convertible Noncontrolling

    Interests and Stockholders' Equity
       
    Accounts payable$8,945 $8,852
    Accrued liabilities75,900 39,455
    LEO call option liability5,550 4,078
    Operating lease liabilities18,472 
    Term loans, current portion1,458 
    Build-to-suit lease obligation 8,000
    Term loans, net of current portion92,421 91,791
    2027 Notes383,436 
    Other liabilities9,520 3,527
    Redeemable convertible noncontrolling interests1,630 2,243
    Total BridgeBio stockholders' equity57,906 408,454
    Noncontrolling interests48,350 65,279
    Total liabilities, redeemable convertible noncontrolling

    interests and stockholders' equity
    $703,588 $631,679



    (1)The condensed consolidated financial statements as of and for the year ended December 31, 2019 are derived from the audited consolidated financial statements as of that date. Certain reclassifications have been made to the condensed consolidated balance sheet as of December 31, 2019.
    (2)December 31, 2019 amounts include long-term marketable securities of $31.1 million.

    About BridgeBio

    BridgeBio is a team of experienced drug discoverers, developers and innovators working to create life-altering medicines that target well-characterized genetic diseases at their source. BridgeBio was founded in 2015 to identify and advance transformative medicines to treat patients who suffer from Mendelian diseases, which are diseases that arise from defects in a single gene, and cancers with clear genetic drivers. BridgeBio's pipeline of over 20 development programs includes product candidates ranging from early discovery to late-stage development.



    BridgeBio Pharma Forward-Looking Statements

    This press release contains forward-looking statements. Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), which are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements relating to expectations, plans and prospects regarding the preclinical and clinical development plans, clinical trial designs, clinical and therapeutic potential, and strategy of our product candidates, including, but not limited to: the unknown future impact of the COVID-19 pandemic delay on certain clinical trial milestones and/or our operations or operating expenses; uncertainty of the expected financial performance of each of us and Eidos following completion of the merger, including the possibility that the expected synergies and value creation from the merger will not be realized or will not be realized within the expected time period; the timing and success of our planned preclinical and clinical development of our development programs, and the timing and success of any such continued preclinical and clinical development and planned regulatory submissions, including for each of acoramidis, infigratinib, BBP-631 and encaleret; the potential therapeutic and clinical benefits of each of acoramidis, infigratinib, BBP-631 and encaleret; the potential size of the target patient populations for each of acoramidis, infigratinib, BBP-631 and encaleret; the timing and approval for commercialization this year for each of infigratinib for the treatment of cholangiocarcinoma and fosdenopterin for the treatment of MoCD Type A; the number of potential medicines in our portfolio; the success of our joint venture with Maze Therapeutics through Contour Therapeutics, our partnership with the University of California, San Francisco, and our other collaboration agreements with various academic institutions; our ability to produce meaningful medicines; the potential for encaleret to be the first approved therapy for ADH1; our expected runway for cash, cash equivalents and marketable securities; our ability to advance infigratinib through the Real-Time Oncology Review pilot program and under Project Orbis; the timing and success of our Phase 1/2 clinical trial of BBP-681; the timing and success of our Phase 1 clinical trial of BBP-398; and the timing of these events, reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by  a number of risks, uncertainties and assumptions, including, but not limited to: the success of clinical trials, regulatory filings, approvals and/or sales; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with our regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those risks set forth in the Risk Factors section of our most recent quarterly or annual periodic report filed with the SEC and our other SEC filings. In addition, the information contained in this release and the condensed consolidated balance sheet information is unaudited and does not present all information necessary for an understanding of the Company's financial condition as of December 31, 2020 and its results of operations for the three months and year ended December 31, 2020. Moreover, BridgeBio operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of BridgeBio's management as of the date of this release and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

    Contact:

    Grace Rauh

    BridgeBio Pharma, Inc.

    Grace.rauh@bridgebio.com

    (917) 232-5478

    Source: BridgeBio Pharma, Inc. 



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  31. SAN FRANCISCO, Feb. 24, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a clinical-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, today announced that early results from an ongoing Phase 2 proof-of-concept study of encaleret for the treatment of Autosomal Dominant Hypocalcemia Type 1 (ADH1) will be shared at the upcoming Endocrine Society's 2021 Annual Meeting (ENDO 2021) taking place virtually from March 20 - 23.

    The data are featured in an ePoster presentation titled ‘The Effects of Encaleret (CLTX-305) on Mineral Physiology in ADH1 Demonstrate Proof-of-Concept: Early Results from an Ongoing Phase…

    SAN FRANCISCO, Feb. 24, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a clinical-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, today announced that early results from an ongoing Phase 2 proof-of-concept study of encaleret for the treatment of Autosomal Dominant Hypocalcemia Type 1 (ADH1) will be shared at the upcoming Endocrine Society's 2021 Annual Meeting (ENDO 2021) taking place virtually from March 20 - 23.

    The data are featured in an ePoster presentation titled ‘The Effects of Encaleret (CLTX-305) on Mineral Physiology in ADH1 Demonstrate Proof-of-Concept: Early Results from an Ongoing Phase 2B, Open-Label, Dose-Ranging Study.' If the development program is successful, encaleret could be the first approved therapy for ADH1, a condition caused by gain of function variants in the calcium-sensing receptor gene estimated to be carried by 12,000 individuals in the United States.

    Full ePoster presentation details are listed below, and the full preliminary program is available online at the ENDO 2021 website. The presentations will be on display in ENDO 2021's virtual poster hall starting on March 20 at 11:00 a.m. ET.

    BridgeBio will host an investor webcast on March 22 at 8:00 a.m. ET to discuss the proof-of-concept data for encaleret in ADH1.

    Additionally at ENDO 2021, BridgeBio will present clinical study designs for its study of low-dose infigratinib, an FGFR1-3 inhibitor, for children with achondroplasia, the most common form of genetic short stature, and for its investigational AAV5 gene therapy candidate for Congenital Adrenal Hyperplasia (CAH). CAH is one of the most prevalent genetic diseases potentially addressable with AAV gene therapy.

    BridgeBio ePoster Presentation Details:

    The Effects of Encaleret (CLTX-305) on Mineral Physiology in ADH1 Demonstrate Proof-of-Concept: Early Results from an Ongoing Phase 2B, Open-Label, Dose-Ranging Study

    Presenter: Rachel Gafni, M.D., Senior Physician of Skeletal Disorders and Mineral Homeostasis of the National Institute of Dental and Craniofacial Research, part of the National Institutes of Health

    Poster Session & Number: P08. Parathyroid and Rare Bone Disorders, Abstract #8545

    A Phase 2B, Open-Label, Dose-Ranging Study of Encaleret (CLTX-305) in ADH1

    Presenter: Rachel Gafni, M.D., Senior Physician of Skeletal Disorders and Mineral Homeostasis of the National Institute of Dental and Craniofacial Research, part of the National Institutes of Health

    Poster Session & Number: P08. Parathyroid and Rare Bone Disorders, Abstract #7288

    Infigratinib in Children with Achondroplasia (ACH): Design of PROPEL2 – A Phase 2, Open-Label, Dose-Escalation and Dose-Expansion Study

    Presenter: Ravi Savarirayan, M.D., Ph.D., Clinical Geneticist and Group Leader of Skeletal Biology and Disease at Murdoch Children's Research Institute

    Poster Session & Number: P34. Disorders of Puberty, Abstract #6897

    Design of a Phase 1/2 Open-Label, Dose-Escalation Study of the Safety and Efficacy of Gene Therapy in Adults with Classic Congenital Adrenal Hyperplasia (CAH) Due to 21-hydroxylase Deficiency Through Administration of an Adeno-Associated Virus (AAV) Serotype 5-Based Recombinant Vector Encoding the Human CYP21A2 Gene

    Presenter: Deborah Merke, M.D., Senior Investigator, Chief of Pediatric Service and Head of Congenital Disorders at the NIH Clinical Center

    Poster Session & Number: P05. Adrenal – Clinical Research Studies, Abstract #8640

    Webcast Information

    BridgeBio will host a conference call and simultaneous webcast to share updates on the encaleret proof-of-concept data in ADH1 on March 22 at 8:00 a.m. ET. To access this call, dial (800) 379-2666 (U.S.) or (409) 937-8964 (International). Conference ID: 7371879. A link to the webcast may be accessed from the event calendar page of BridgeBio's website at https://investor.bridgebio.com/. A replay of the conference call and webcast will be archived on the Company's website and will be available for at least 30 days following the event. 

    About BridgeBio Pharma, Inc.

    BridgeBio is a team of experienced drug discoverers, developers and innovators working to create life-altering medicines that target well-characterized genetic diseases at their source. BridgeBio was founded in 2015 to identify and advance transformative medicines to treat patients who suffer from Mendelian diseases, which are diseases that arise from defects in a single gene, and cancers with clear genetic drivers. BridgeBio's pipeline of over 20 development programs includes product candidates ranging from early discovery to late-stage development. For more information, please visit www.bridgebio.com.

    BridgeBio Pharma Forward Looking Statements

    This press release contains forward-looking statements. Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), which are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements relating to expectations, plans and prospects regarding the preclinical and clinical development plans, clinical trial designs, clinical and therapeutic potential, and strategy of our product candidates, including, but not limited to: the unknown future impact of the COVID-19 pandemic delay on certain clinical trial milestones and/or our operations or operating expenses;; the timing and success of our planned preclinical and clinical development of our development programs, including each of infigratinib, BBP-631 and encaleret; the timing and success of any such continued preclinical and clinical development and planned regulatory submissions, including for each of infigratinib, BBP-631 and encaleret; the potential therapeutic and clinical benefits of each of infigratinib, BBP-631 and encaleret; the potential size of the target patient populations for each of infigratinib, BBP-631 and encaleret; the potential for encaleret to be the first approved therapy for ADH1; our expected runway for cash, cash equivalents and marketable securities; and the timing of these events, reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to: the success of clinical trials, regulatory filings, approvals and/or sales; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with our regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those risks set forth in the Risk Factors section of our most recent quarterly or annual periodic report filed with the SEC and our other SEC filings. Moreover, BridgeBio operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of BridgeBio's management as of the date of this release and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

    Contact:

    Grace Rauh

    BridgeBio Pharma, Inc.

    Grace.rauh@bridgebio.com

    (917) 232-5478

    Source: BridgeBio Pharma, Inc.



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  32. SAN FRANCISCO, Feb. 19, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a clinical-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, and affiliate ML Bio Solutions today announced that the first patient has been dosed in a Phase 2 trial of BBP-418 in patients with LGMD2i. BridgeBio and ML Bio's BBP-418 is the first-ever oral disease-modifying investigational treatment for LGMD2i. BBP-418 was granted Orphan Drug Designation for LGMD2i by the US Food and Drug Administration (FDA) in 2019, and for LGMD by the European Medicines Agency (EMA) in 2020.

    LGMD2i is an inherited recessive muscular dystrophy caused…

    SAN FRANCISCO, Feb. 19, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a clinical-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, and affiliate ML Bio Solutions today announced that the first patient has been dosed in a Phase 2 trial of BBP-418 in patients with LGMD2i. BridgeBio and ML Bio's BBP-418 is the first-ever oral disease-modifying investigational treatment for LGMD2i. BBP-418 was granted Orphan Drug Designation for LGMD2i by the US Food and Drug Administration (FDA) in 2019, and for LGMD by the European Medicines Agency (EMA) in 2020.

    LGMD2i is an inherited recessive muscular dystrophy caused by mutation of fukutin-related protein (FKRP). FKRP is an enzyme that adds a sugar molecule to a critical muscle cell structural protein called alpha-dystroglycan (αDG). Due to defective FKRP enzyme function, muscle cells of patients affected by LGMD2i lack the structural integrity that is provided by fully glycosylated αDG protein. This leads to chronic muscle injury and loss, muscle weakness and disability. Many affected patients ultimately lose their ability to walk, and some develop a need for ventilatory support or die from heart failure. Currently, there are no disease-modifying therapies for people with LGMD2i. 

    BBP-418 is designed to bypass the metabolic defect in LGMD2i by providing the FKRP enzyme with precursor sugar molecules that supplement the body's natural sugars used by FKRP to glycosylate the αDG protein on muscle cells. BBP-418 represents a novel substrate rescue approach with the potential to improve muscle strength and function. 



    The Phase 2 trial is expected to enroll up to 16 patients with a genetically-confirmed diagnosis of LGMD2i. In addition to safety, key efficacy measurements include changes in muscle αDG glycosylation levels, and changes in functional measures including 10 meter walk and North Star for Dysferlinopathy (NSAD).

    "The start of our Phase 2 trial is a key milestone in our effort to develop a safe and efficacious therapy for patients with LGMD2i who lack treatment options," said Dr. Douglas Sproule, M.D. M.Sc., Chief Medical Officer of ML Bio Solutions. "This trial launch is an outgrowth of our strong partnership with the GRASP-LGMD consortium based at Virginia Commonwealth University, where we are currently enrolling a lead-in study to define LGMD2i-specific biomarkers and functional endpoints. Our hope is that the ongoing lead-in study, together with early data from our Phase 2 trial, will hasten the successful execution of a future registrational trial and ultimately advance a meaningful medicine for patients in need." 

    "We are pleased to continue our collaboration with ML Bio Solutions on the lead-in study that is currently enrolling and look forward to further extending it by launching the first-in-patient treatment study for BBP-418. Our clinical partnership is seeking to validate the biomarker assays and establish the registrational clinical outcome measures that are needed to bring BBP-418 to LGMD2i patients," said Dr. Nicholas Johnson M.D. M.S.C.I., Associate Professor of Neurology and Chair of Research at Virginia Commonwealth University and Director of the GRASP-LGMD consortium.  

    About GRASP-LGMD (Genetic Resolution and Assessments Solving Phenotypes in LGMD) Consortium  

    The GRASP-LGMD consortium assembles an international team of neuromuscular specialists, basic scientists, physical therapists, geneticists, informaticians, and patient advocates to address issues related to: diagnostics; outcome measure development, patient engagement; and therapeutic development, to advance the state of LGMD research and readiness to support translation of science into therapeutic development.  For more information visit: http://www.grasp-lgmd.org 

    About ML Bio Solutions 

    ML Bio Solutions, an affiliate of BridgeBio Pharma based in a Charlotte, NC, is a biotechnology company focused on developing a small molecule as an oral substrate supplementation therapy for LGMD2i. ML Bio Solutions is led by a team of veteran biotechnology executives, and together with patients and physicians, aims to bring safe, effective treatments to market as quickly as possible. For more information, visit mlbiosolutions.com. 

    About BridgeBio Pharma 

    BridgeBio is a team of experienced drug discoverers, developers and innovators working to create life-altering medicines that target well-characterized genetic diseases at their source. BridgeBio was founded in 2015 to identify and advance transformative medicines to treat patients who suffer from Mendelian diseases, which are diseases that arise from defects in a single gene, and cancers with clear genetic drivers. BridgeBio's pipeline of over 20 development programs includes product candidates ranging from early discovery to late-stage development. For more information, visit bridgebio.com

    BridgeBio Pharma Forward-Looking Statements 

    This press release contains forward-looking statements. Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), which are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions.  We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions.  These forward-looking statements, including statements relating to the timing and success of ML Bio Solutions' Phase 2 clinical trial of BBP-418 for the treatment of LGMD2i, expectations, plans and prospects regarding ML Bio Solutions' regulatory approval process for BBP-418, the ability of BBP-418 to treat LGMD2i in humans, and the timing and success of initial top-line Phase 2 date of BBP-418, reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved.  Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, ML Bio Solutions' ability to continue and complete its Phase 2 clinical trial of BBP-418 for the treatment of LDMD2i, the continuing success of ML Bio Solutions' collaboration with the GRASP-LGMD consortium based at Virginia Commonwealth University, past data from preclinical studies not being indicative of future data from clinical trials, ML Bio Solutions' ability to advance BBP-418 in clinical development according to its plans, the ability of BBP-418 to treat LGMD2i, as well as those risks set forth in the Risk Factors section of BridgeBio Pharma's most recent Quarterly Report on Form 10-Q and BridgeBio Pharma's other SEC filings. Moreover, ML BioSolutions operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. 

    Contact: 

    Grace Rauh, BridgeBio Pharma 

    grace.rauh@bridgebio.com 

    917-232-5478 

    Source: BridgeBio Pharma  



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  33. PALO ALTO, Calif. , Feb. 12, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) (the "Company," "we" or "BridgeBio") announced today the pricing of a secondary public offering of 3,000,000 shares of its common stock at a price per share of $62.50 by selling stockholder KKR Genetic Disorder L.P. The selling stockholder has also granted the underwriters a 30-day option to purchase up to 450,000 additional shares of common stock on the same terms and conditions. All shares are being sold by KKR Genetic Disorder L.P. The Company is not selling any shares and will not receive any of the proceeds of the offering. The offering is expected to close on February 17, 2021, subject to customary closing conditions.

    Goldman Sachs & Co. LLC…

    PALO ALTO, Calif. , Feb. 12, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) (the "Company," "we" or "BridgeBio") announced today the pricing of a secondary public offering of 3,000,000 shares of its common stock at a price per share of $62.50 by selling stockholder KKR Genetic Disorder L.P. The selling stockholder has also granted the underwriters a 30-day option to purchase up to 450,000 additional shares of common stock on the same terms and conditions. All shares are being sold by KKR Genetic Disorder L.P. The Company is not selling any shares and will not receive any of the proceeds of the offering. The offering is expected to close on February 17, 2021, subject to customary closing conditions.

    Goldman Sachs & Co. LLC is acting as the sole book-running manager, and KKR Capital Markets LLC and Raymond James & Associates, Inc. are acting as co-managers for the offering.

    The securities described above are being offered pursuant to an automatic shelf registration statement on Form S-3 (File No. 333-240147) that was previously filed by the Company with the Securities and Exchange Commission (the "SEC") and automatically became effective upon filing on July 28, 2020.

    A preliminary prospectus supplement and accompanying prospectus relating to the offering are filed with the SEC and are available on the SEC's website at http://www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus and, when available, copies of the final prospectus supplement and accompanying prospectus can be obtained by contacting Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at 1 866 471 2526, or by email at prospectusny@ny.email.gs.com.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities described above, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About BridgeBio

    BridgeBio is a team of experienced drug discoverers, developers and innovators working to create life-altering medicines that target well-characterized genetic diseases at their source. BridgeBio was founded in 2015 to identify and advance transformative medicines to treat patients who suffer from Mendelian diseases, which are diseases that arise from defects in a single gene, and cancers with clear genetic drivers. BridgeBio's pipeline of over 20 development programs includes product candidates ranging from early discovery to late-stage development.

    Forward-Looking Statements

    This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), which are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements reflect our current views about our plans, intentions, expectations and strategies, which are based on the information currently available to us and on assumptions we have made.

    Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our Annual Report on Form 10-K for the year ended December 31, 2019, our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 and our other filings with the SEC. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

    Contact:

    Grace Rauh

    BridgeBio Pharma, Inc.

    Grace.rauh@bridgebio.com 

    (917) 232-5478

    Source: BridgeBio Pharma, Inc.



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  34. PALO ALTO, Calif., Feb. 11, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) (the "Company," "we" or "BridgeBio") announced today the launch of a secondary public offering of 3,000,000 shares of its common stock by selling stockholder KKR Genetic Disorder L.P. The selling stockholder has also granted the underwriters a 30-day option to purchase up to 450,000 additional shares of common stock. All shares are being sold by KKR Genetic Disorder L.P. The Company is not selling any shares and will not receive any of the proceeds of the offering.

    Goldman Sachs & Co. LLC is acting as the sole book-running manager and KKR Capital Markets LLC and Raymond James & Associates, Inc. are acting as co-managers for the offering.

    The securities…

    PALO ALTO, Calif., Feb. 11, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) (the "Company," "we" or "BridgeBio") announced today the launch of a secondary public offering of 3,000,000 shares of its common stock by selling stockholder KKR Genetic Disorder L.P. The selling stockholder has also granted the underwriters a 30-day option to purchase up to 450,000 additional shares of common stock. All shares are being sold by KKR Genetic Disorder L.P. The Company is not selling any shares and will not receive any of the proceeds of the offering.

    Goldman Sachs & Co. LLC is acting as the sole book-running manager and KKR Capital Markets LLC and Raymond James & Associates, Inc. are acting as co-managers for the offering.

    The securities described above are being offered pursuant to an automatic shelf registration statement on Form S-3 (File No. 333-240147) that was previously filed by the Company with the Securities and Exchange Commission (the "SEC") and automatically became effective upon filing on July 28, 2020.

    A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC's website at http://www.sec.gov. A copy of the preliminary prospectus supplement and accompanying prospectus can be obtained by contacting Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at 1 866 471 2526, or by email at prospectusny@ny.email.gs.com.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities described above, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About BridgeBio

    BridgeBio is a team of experienced drug discoverers, developers and innovators working to create life-altering medicines that target well-characterized genetic diseases at their source. BridgeBio was founded in 2015 to identify and advance transformative medicines to treat patients who suffer from Mendelian diseases, which are diseases that arise from defects in a single gene, and cancers with clear genetic drivers. BridgeBio's pipeline of over 20 development programs includes product candidates ranging from early discovery to late-stage development.

    Forward-Looking Statements

    This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), which are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements reflect our current views about our plans, intentions, expectations and strategies, which are based on the information currently available to us and on assumptions we have made.

    Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our Annual Report on Form 10-K for the year ended December 31, 2019, our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 and our other filings with the SEC. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

    Contact:

    Grace Rauh

    BridgeBio Pharma, Inc.

    Grace.rauh@bridgebio.com

    (917) 232-5478

    Source: BridgeBio Pharma, Inc.



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  35. PALO ALTO, Calif., Feb. 05, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a clinical-stage biopharmaceutical company focused on genetic diseases, today announced that on February 1, 2021, the compensation committee of BridgeBio's board of directors granted 11 new employees restricted stock units for an aggregate of 16,772 shares of the Company's common stock. All of the above-described awards were made under BridgeBio's 2019 Inducement Equity Plan (the Plan).

    The above-described awards were each granted as an inducement material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4), and were granted pursuant to the terms of the Plan. The Plan was adopted by BridgeBio's…

    PALO ALTO, Calif., Feb. 05, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a clinical-stage biopharmaceutical company focused on genetic diseases, today announced that on February 1, 2021, the compensation committee of BridgeBio's board of directors granted 11 new employees restricted stock units for an aggregate of 16,772 shares of the Company's common stock. All of the above-described awards were made under BridgeBio's 2019 Inducement Equity Plan (the Plan).

    The above-described awards were each granted as an inducement material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4), and were granted pursuant to the terms of the Plan. The Plan was adopted by BridgeBio's board of directors in November 2019.

    About BridgeBio

    BridgeBio a team of experienced drug discoverers, developers and innovators working to create life-altering medicines that target well-characterized genetic diseases at their source. BridgeBio was founded in 2015 to identify and advance transformative medicines to treat patients who suffer from Mendelian diseases, which are diseases that arise from defects in a single gene, and cancers with clear genetic drivers. BridgeBio's pipeline of over 20 development programs includes product candidates ranging from early discovery to late-stage development.

    Media Contact:

    Grace Rauh

    Grace.rauh@bridgebio.com

    (917) 232-5478

    Source: BridgeBio Pharma, Inc.



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    • First-in-human Phase 1/2 trial in patients with venous malformations (VMs), lymphatic malformations (LMs), and venolymphatic malformations (VLMs) associated with PIK3CA or TEK mutations
    • Clinical trial enrolling patients across multiple sites in the United States

    PALO ALTO, Calif., Feb. 02, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) and affiliate Venthera, which is focused on developing new treatment options for patients with rare vascular anomalies, today announced that the first patient has been dosed in its Phase 1/2 clinical trial of BBP-681 (also known as VT30 Topical Gel).

    This novel investigational therapy is designed to target the genetic drivers of venous (VM), lymphatic (LM), and venolymphatic malformations (VLM…

    • First-in-human Phase 1/2 trial in patients with venous malformations (VMs), lymphatic malformations (LMs), and venolymphatic malformations (VLMs) associated with PIK3CA or TEK mutations

    • Clinical trial enrolling patients across multiple sites in the United States

    PALO ALTO, Calif., Feb. 02, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) and affiliate Venthera, which is focused on developing new treatment options for patients with rare vascular anomalies, today announced that the first patient has been dosed in its Phase 1/2 clinical trial of BBP-681 (also known as VT30 Topical Gel).

    This novel investigational therapy is designed to target the genetic drivers of venous (VM), lymphatic (LM), and venolymphatic malformations (VLM) at their source by delivering a potent PI3Kα inhibitor directly to affected tissue. The majority of these cutaneous vascular malformations are driven by somatic mutations in the PIK3CA and TEK genes. These mutations result in overactivation of the PI3K pathway and have been identified as the root cause of the vast majority of VMs, LMs, and VLMs. Because BBP-681 is applied directly to skin lesions, it may minimize complications seen with systemic treatments.

    Part 1 of the trial is a four-week treatment, open-label dose escalation study which will determine the dose and regimen of BBP-681 to be carried into Part 2 of the protocol. Part 2 is a 12-week treatment, randomized, placebo-controlled, double-blind, safety and exploratory efficacy study of topically administered BBP-681.

    People living with VMs, LMs, and VLMs have significant unmet medical needs related to pain, functional impairment, and disfigurement. Current treatment options include laser ablation, and invasive procedures such as sclerotherapy and surgical excision. BBP-681 is the first potential therapy designed specifically to address the needs of people living with cutaneous forms of these lesions. There are 117,000 people estimated to be living with cutaneous VMs, LMs, and VLMs in the United States and Europe.

    "We are dedicated to giving hope to patients by developing new treatment options and working to improve mobility and alleviate discomfort of people living with cutaneous VMs, LMs, and VLMs. The initiation of this study represents an important milestone for the patient community as we translate cutting-edge science into a clinical-stage investigational therapy designed to target these conditions at their known genetic and tissue-specific source," said Thomas M. Rossi, Ph.D., CEO of Venthera.



    The Phase 1/2 study is currently enrolling up to 51 patients with VMs, LMs, and VLMs associated with PIK3CA or TEK gene mutations across multiple centers in the U.S. to evaluate the safety and tolerability of BBP-681. The study will also determine the dose and regimen of BBP-681 to be carried into Part 2 of the protocol. Other aims include documenting plasma drug levels of BBP-681 and its active form VT10 and, on an exploratory basis, examining pharmacologic target engagement and change in potential efficacy readouts. For more information, visit https://clinicaltrials.gov/ct2/show/NCT04409145.

    About Venthera

    Venthera is dedicated to improving the lives of patients living with rare vascular anomalies by suppressing the underlying pathways that drive vascular anomaly growth. By targeting the genetic root cause of disease(s), Venthera is seeking to address unmet needs and create a new option for treating VMs, LMs, and VLMs with the hope of reducing the need for invasive and systemic treatments.

    As a member of the BridgeBio family, Venthera's management team is supported by deep expertise in drug discovery, development, and innovation that advances its mission to bring safe and efficient new treatments to patients living with rare vascular anomalies.

    About BridgeBio

    BridgeBio is a team of experienced drug discoverers, developers and innovators working to create life-altering medicines that target well-characterized genetic diseases at their source. BridgeBio was founded in 2015 to identify and advance transformative medicines to treat patients who suffer from Mendelian diseases, which are diseases that arise from defects in a single gene, and cancers with clear genetic drivers. BridgeBio's pipeline of over 20 development programs includes product candidates ranging from early discovery to late-stage development. For more information, visit https://bridgebio.com/.

    BridgeBio Pharma Forward-Looking Statements

    This press release contains forward-looking statements. Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), which are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements relating to the timing and success of Venthera's Phase 1/2 clinical trial of BBP-681/VT30 for the treatment of venous malformations, lymphatic malformations, and venolymphatic malformations associated with PIK3CA or TEK mutations, expectations, plans and prospects regarding Venthera's regulatory approval process for BBP-681/VT30, the ability of BBP-681/VT30 to treat venous malformations, lymphatic malformations, and venolymphatic malformations associated with PIK3CA or TEK mutations in humans, and the timing and success of initial top-line Phase 1/2 data of BBP-681/VT-30, reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, Venthera's ability to continue and complete its Phase 1/2 clinical trial of BBP-681/VT30 for the treatment of venous malformations, lymphatic malformations, and venolymphatic malformations associated with PIK3CA or TEK mutations, past data from preclinical studies not being indicative of future data from clinical trials, Venthera's ability to advance BBP-681/VT30 in clinical development according to its plans, the ability of BBP-681/VT30 to treat venous malformations, lymphatic malformations, and venolymphatic malformations associated with PIK3CA or TEK mutations, as well as those risks set forth in the Risk Factors section of BridgeBio Pharma's most recent Quarterly Report on Form 10-Q and BridgeBio Pharma's other SEC filings. Moreover, Venthera operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

    Contact:

    Grace Rauh, BridgeBio Pharma

    grace.rauh@bridgebio.com

    917-232-5478

    Source: BridgeBio Pharma

     



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  36. PALO ALTO, Calif., Jan. 26, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. ("BridgeBio") (NASDAQ:BBIO) today announced that it has completed its acquisition of all of the outstanding shares of Eidos Therapeutics, Inc. ("Eidos") (NASDAQ:EIDX) common stock that BridgeBio did not already own. The transaction was overwhelmingly approved by BridgeBio and Eidos stockholders. 

    The merger reunites the teams at BridgeBio and Eidos and allows BridgeBio to deploy its full clinical and commercial infrastructure to support the development and global commercialization plans underway for Eidos' acoramidis, a potential best-in-class therapy for patients with transthyretin (TTR) amyloidosis (ATTR). BridgeBio's mission is to discover, create, test and deliver…

    PALO ALTO, Calif., Jan. 26, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. ("BridgeBio") (NASDAQ:BBIO) today announced that it has completed its acquisition of all of the outstanding shares of Eidos Therapeutics, Inc. ("Eidos") (NASDAQ:EIDX) common stock that BridgeBio did not already own. The transaction was overwhelmingly approved by BridgeBio and Eidos stockholders. 

    The merger reunites the teams at BridgeBio and Eidos and allows BridgeBio to deploy its full clinical and commercial infrastructure to support the development and global commercialization plans underway for Eidos' acoramidis, a potential best-in-class therapy for patients with transthyretin (TTR) amyloidosis (ATTR). BridgeBio's mission is to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers.

    "2021 is an important year for BridgeBio and the patients we serve," said Neil Kumar, Ph.D., founder and CEO of BridgeBio. "With significant near-term pivotal and proof-of-concept data anticipated in our four core programs, including acoramidis, we are eager to accelerate our critical work for patients as a single unified company."

    Acoramidis for ATTR is one of BridgeBio's four core value driver programs, along with encaleret (CaSR inhibitor) for autosomal dominant hypocalcemia type 1 (ADH1), low-dose infigratinib (FGFR inhibitor) for achondroplasia, and BBP-631, an AAV5 gene therapy for congenital adrenal hyperplasia (CAH). 2021 is poised to be a transformational year for BridgeBio with major catalysts in all four programs anticipated in 2021 or the first quarter of 2022. This year BridgeBio also expects to launch two drugs, if approved, and is building its global commercial capabilities.

    • Acoramidis (AG10) – TTR stabilizer for ATTR:  Topline results from Part A of the ATTRibute-CM trial are expected in late 2021 or early 2022 and from Part B in 2023. If Part A is successful, BridgeBio expects to file for regulatory approval of acoramidis in 2022. ATTR is a form of amyloidosis caused by the accumulation of misfolded TTR protein. It is estimated to affect more than 400,000 people worldwide and is largely undiagnosed today.



    • Encaleret – calcium-sensing receptor (CaSR) inhibitor for ADH1: Phase 2 proof-of-concept results are anticipated in the third quarter of 2021. If the development program is successful, encaleret would be the first approved therapy for ADH1, a condition caused by gain of function variants in the CASR gene estimated to be carried by 12,000-13,000 individuals in the United States alone.



    • Low-dose infigratinib – FGFR1-3 inhibitor for achondroplasia: Initial data from the ongoing Phase 2 dose ranging study are expected in the fourth quarter of 2021. Achondroplasia is the most common form of genetic short stature and one of the most common genetic diseases, with 55,000 cases in the United States and European Union. Low-dose infigratinib is the only known therapy in development for achondroplasia that targets the disease at its genetic source and the only orally administered product candidate in clinical stage development.



    • BBP-631 – AAV5 gene therapy candidate for CAH:  Initiation of a first-in-human Phase 1/2 study is expected in 2021, with initial data anticipated in the fourth quarter of 2021 or the first quarter of 2022. CAH is one of the most prevalent genetic diseases potentially addressable with AAV gene therapy, with more than 75,000 cases in the United States and European Union. The disease is caused by deleterious mutations in the gene encoding an enzyme called 21-hydroxylase, leading to lack of endogenous cortisol production. BridgeBio's AAV gene therapy candidate is designed to provide a functional copy of the 21-hydroxylase-encoding gene (CYP21A2) and potentially address many aspects of the disease course.

    As a result of the merger, former Eidos stockholders are entitled to receive, for each share of Eidos common stock issued and outstanding immediately prior to the effective time of the merger that was not owned by BridgeBio or any of its subsidiaries and that was not a restricted share award, either (i) 1.85 shares of BridgeBio common stock or (ii) if an election to receive cash was properly made prior to 5:00 P.M., New York City time, on January 21, 2021, $73.26 in cash. Eidos stockholders should contact American Stock Transfer & Trust Company, LLC, the exchange agent for the transaction, by calling toll-free at (877) 248-6417 or at (718) 921-8317, if they have any questions regarding the consideration to which they are entitled.

    About BridgeBio Pharma

    BridgeBio Pharma is a team of experienced drug discoverers, developers and innovators working to create life-altering medicines that target well-characterized genetic diseases at their source. BridgeBio was founded in 2015 to identify and advance transformative medicines to treat patients who suffer from Mendelian diseases, which are diseases that arise from defects in a single gene, and cancers with clear genetic drivers. BridgeBio's pipeline of over 20 development programs includes product candidates ranging from early discovery to late-stage development. For more information visit www.bridgebio.com.

    About Eidos Therapeutics

    Eidos Therapeutics is a clinical stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin (TTR) amyloidosis (ATTR). Eidos is developing acoramidis, a potentially disease-modifying therapy for the treatment of ATTR. For more information, visit www.eidostx.com.

    Forward-Looking Statements

    This press release contains forward-looking statements relating to the proposed transaction involving BridgeBio and Eidos, including financial estimates and statements as to the expected timing, completion and effects of the proposed transaction. Statements in this press release that are not statements of historical fact are considered forward-looking statements within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), which are usually identified by the use of words such as "anticipates," "believes," "continues", "could", "estimates," "expects," "intends," "may," "plans," "potential", "predicts", "projects," "seeks," "should," "will," and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements are neither forecasts, promises nor guarantees, and are based on the current beliefs of BridgeBio's management as well as assumptions made by and information currently available to BridgeBio. Such statements reflect the current views of BridgeBio with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about BridgeBio and Eidos, including, without limitation, (i) potential adverse effects or changes to relationships with customers, employees, suppliers or other parties resulting from the completion of the merger, (ii) potential litigation relating to the merger that could be instituted against BridgeBio, Eidos or their respective directors and officers, including the effects of any outcomes related thereto, (iii) possible disruptions from the merger that could harm BridgeBio's or Eidos' respective business, including current plans and operations, (iv) unexpected costs, charges or expenses resulting from the merger, (v) uncertainty of the expected financial performance of each of BridgeBio and Eidos following completion of the merger, including the possibility that the expected synergies and value creation from the merger will not be realized or will not be realized within the expected time period, (vi) the ability of BridgeBio and/or Eidos to implement their respective business strategies, (vii) the ability of each of BridgeBio or Eidos to continue its planned preclinical and clinical development of its respective development programs, and the timing and success of any such continued preclinical and clinical development and planned regulatory submissions, including for BridgeBio's low-dose infigratinib (FGFR inhibitor) for achondroplasia, AAV5 gene therapy for congenital adrenal hyperplasia (CAH), acoramidis and encaleret for ADH1, (viii) the potential therapeutic and clinical benefits of each of acoramidis, infigratinib, BBP-631 and encaleret, (ix) the potential size of the target patient populations for each of acoramidis, infigratinib, BBP-631 and encaleret, (x) the potential for encaleret to be the first approved therapy for ADH1, (xi) inability to retain and hire key personnel and (xii) the unknown future impact of the COVID-19 pandemic delay on certain clinical trial milestones and/or BridgeBio's or Eidos' operations or operating expenses. Although BridgeBio believes that BridgeBio's and Eidos' plans, intentions, expectations, strategies and prospects as reflected in or suggested by these forward-looking statements are reasonable, BridgeBio cannot give any assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, without limitation, those risks and uncertainties described under the heading "Risk Factors" in BridgeBio's most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K filed with the SEC and in subsequent filings made by BridgeBio with the SEC, which are available on the SEC's website at www.sec.gov. Moreover, BridgeBio operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of BridgeBio's management as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. We anticipate that subsequent events and developments will cause our views to change. Except as required by law, BridgeBio disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.

    Contact:

    Grace Rauh

    BridgeBio Pharma, Inc.

    grace.rauh@bridgebio.com

    917-232-5478

    Source: BridgeBio Pharma, Inc.



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  37. PALO ALTO, Calif., Jan. 25, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) (the "Company," "we" or "BridgeBio") announced today the pricing of $650 million aggregate principal amount of 2.25% convertible senior notes due 2029 (the "notes") in a private offering (the "offering") to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). The offering was upsized from the previously announced offering of $400 million aggregate principal amount of notes. In connection with the offering, the Company granted the initial purchasers an option to purchase up to an additional $97.5 million aggregate principal amount of notes. The sale of the notes is expected to close on…

    PALO ALTO, Calif., Jan. 25, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) (the "Company," "we" or "BridgeBio") announced today the pricing of $650 million aggregate principal amount of 2.25% convertible senior notes due 2029 (the "notes") in a private offering (the "offering") to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). The offering was upsized from the previously announced offering of $400 million aggregate principal amount of notes. In connection with the offering, the Company granted the initial purchasers an option to purchase up to an additional $97.5 million aggregate principal amount of notes. The sale of the notes is expected to close on January 28, 2021, subject to customary closing conditions.

    The notes will bear interest at a rate of 2.25% per year, payable semi-annually in arrears on February 1 and August 1 of each year, beginning August 1, 2021. The notes will mature on February 1, 2029, unless earlier converted, redeemed or repurchased. Prior to November 1, 2028, the notes will be convertible only upon satisfaction of certain conditions and during certain periods. Thereafter, the notes will be convertible at any time until the close of business on the second scheduled trading day immediately preceding the maturity date. The notes will be convertible at the option of the holders, subject to certain conditions and during certain periods, into cash, shares of the Company's common stock or a combination of cash and shares of the Company's common stock, with the form of consideration determined at the Company's election.

    The conversion rate will initially be 10.3050 shares of the Company's common stock per $1,000 principal amount of notes (equivalent to an initial conversion price of approximately $97.04 per share of the Company's common stock). The initial conversion price of the notes represents a premium of approximately 47.5% over the last reported sale price of the Company's common stock of $65.79 per share on January 25, 2021.

    The Company may not redeem the notes prior to February 6, 2026. On or after February 6, 2026 and on or before the 41st scheduled trading day immediately before the maturity date of the notes, the Company may redeem for cash all or any portion of the notes, at its option at any time, and from time to time, if the last reported sale price of the Company's common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive), including the trading day immediately preceding the date on which the Company provides notice of redemption, during any 30 consecutive trading day period ending on, and including, the trading day immediately preceding the date on which the Company provides notice of redemption at a redemption price equal to 100% of the principal amount of the notes being redeemed, plus accrued and unpaid interest to, but excluding, the redemption date.

    Holders of the notes will have the right to require the Company to repurchase all or a portion of their notes at 100% of their principal amount, plus any accrued and unpaid interest, upon the occurrence of certain events.

    When issued, the notes will be the Company's senior unsecured obligations and will rank senior in right of payment to any of the Company's unsecured indebtedness that is expressly subordinated in right of payment to the notes; equal in right of payment to any of the Company's unsecured indebtedness that is not so subordinated (including the Company's 2.50% Convertible Senior Notes due 2027); effectively junior in right of payment to any of the Company's secured indebtedness to the extent of the value of the assets securing such indebtedness; and structurally junior to all indebtedness and other liabilities (including trade payables) of the Company's subsidiaries.

    In connection with the pricing of the notes, the Company entered into privately negotiated capped call transactions with certain of the initial purchasers and/or their respective affiliates and certain other financial institutions (the "option counterparties"). These capped call transactions are expected generally to reduce the potential dilution to the Company's common stock upon any conversion of the notes and/or offset any cash payments the Company is required to make in excess of the principal amount of converted notes, as the case may be, with such reduction of potential dilution and/or offset of cash payments subject to a cap. The cap price of the capped call transactions will initially be $131.58 per share, which represents a premium of 100% over the last reported sale price of the Company's common stock of $65.79 per share on January 25, 2021, and is subject to certain adjustments under the terms of the capped call transactions.

    The Company has been advised that, in connection with establishing their initial hedges of the capped call transactions, the option counterparties or their respective affiliates expect to enter into various derivative transactions with respect to the Company's common stock concurrently with or shortly after the pricing of the notes and/or purchase shares of the Company's common stock concurrently with or shortly after the pricing of the notes. This activity could increase (or reduce the size of any decrease in) the market price of the Company's common stock, the notes or the Company's 2.50% Convertible Senior Notes due 2027 at that time. In addition, the option counterparties or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to the Company's common stock and/or purchasing or selling the Company's common stock or other securities of the Company in secondary market transactions from time to time prior to maturity of the notes (and are likely to do so following any conversion of the notes, any redemption date or any repurchase of the notes by the Company on any fundamental change repurchase date or otherwise, in each case, if the Company exercises the relevant election under the capped call transactions). This activity could also cause or avoid an increase or a decrease in the market price of the Company's common stock or the notes, which could affect the ability of holders to convert the notes and, to the extent the activity occurs during any observation period related to a conversion of the notes, it could affect the number of shares of the Company's common stock, if any, and value of the consideration that holders will receive upon conversion of the notes.

    Further, if any such capped call transactions fail to become effective, whether or not the offering of notes is completed, the option counterparties or their respective affiliates may unwind their hedge positions with respect to the Company's common stock, which could adversely affect the value of the Company's common stock and, if the notes have been issued, the value of the notes.

    The Company estimates that the net proceeds from the offering of notes will be approximately $635 million (or approximately $731 million if the initial purchasers exercise their option to purchase additional notes in full), after deducting the initial purchasers' discounts and estimated offering expenses payable by the Company. The Company intends to use $53.3 million of the net proceeds from the offering of the notes to pay the cost of the capped call transactions, and approximately $50 million of the net proceeds from the offering to repurchase shares of its common stock concurrently with the closing of the offering from certain purchasers of the notes in privately negotiated transactions entered into through one or more of the initial purchasers or an affiliate thereof concurrently with the pricing of the notes (such transactions, the "share repurchases"). The agreed to purchase price per share of the Company's common stock in such share repurchases is equal to the last reported sale price of the Company's common stock of $65.79 per share on the Nasdaq Global Select Market on January 25, 2021. The share repurchases could increase (or reduce the size of any decrease in) the market price of the Company's common stock. If the initial purchasers exercise their option to purchase additional notes in full, the Company expects to use approximately $8.0 million of the net proceeds from the sale of such additional notes to enter into additional capped call transactions. The Company intends to use the remainder of the net proceeds from the offering for general corporate purposes, which may include research and development and clinical development costs to support the advancement of the Company's drug candidates, including the continued growth of the Company's commercial and medical affairs capabilities, the conduct of clinical trials and preclinical research and development activities; working capital; capital expenditures; repayment of outstanding indebtedness; general and administrative expenses; and other general corporate purposes. The Company may also use net proceeds to fund potential acquisitions of, or investments in, complementary businesses, products, services and technologies. The Company has not entered into any agreements or commitments with respect to any material acquisitions or investments at this time that would be financed with any of the net proceeds from the offering of notes. From time to time, to maintain or increase the Company's ownership position in its subsidiaries, the Company may make additional investments in or purchase equity in its subsidiaries. These expectations and intentions are subject to change.

    The notes and the shares of common stock issuable upon conversion of the notes, if any, are not being registered under the Securities Act, or the securities laws of any other jurisdiction. The notes and the shares of common stock issuable upon conversion of the notes, if any, may not be offered or sold in the United States except in transactions exempt from, or not subject to, the registration requirements of the Securities Act and any applicable state securities laws.

    This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

    About BridgeBio

    BridgeBio is a team of experienced drug discoverers, developers and innovators working to create life-altering medicines that target well-characterized genetic diseases at their source. BridgeBio was founded in 2015 to identify and advance transformative medicines to treat patients who suffer from Mendelian diseases, which are diseases that arise from defects in a single gene, and cancers with clear genetic drivers. BridgeBio's pipeline of over 20 development programs includes product candidates ranging from early discovery to late-stage development.

    Forward-Looking Statements

    This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), which are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements, including statements relating to whether we will issue the notes, the anticipated use of the net proceeds of the offering, the expectations regarding the effect of the share repurchases and the capped call transactions and regarding actions of the option counterparties and their respective affiliates, and whether the capped call transactions will become effective, reflect our current views about our plans, intentions, expectations and strategies, which are based on the information currently available to us and on assumptions we have made.

    Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our Annual Report on Form 10-K for the year ended December 31, 2019, our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 and our other filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

    Contact:

    Grace Rauh

    BridgeBio Pharma, Inc.

    Grace.rauh@bridgebio.com

    (917) 232-5478

    Source: BridgeBio Pharma, Inc.

     



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  38. PALO ALTO, Calif., Jan. 25, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) (the "Company," "we" or "BridgeBio") announced today that it intends to offer, subject to market conditions and other factors, $400 million aggregate principal amount of convertible senior notes due 2029 (the "notes") in a private offering (the "offering") to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). In connection with the offering, the Company expects to grant the initial purchasers an option to purchase up to an additional $60 million aggregate principal amount of notes.

    The final terms of the notes, including the initial conversion rate, interest rate and certain other…

    PALO ALTO, Calif., Jan. 25, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) (the "Company," "we" or "BridgeBio") announced today that it intends to offer, subject to market conditions and other factors, $400 million aggregate principal amount of convertible senior notes due 2029 (the "notes") in a private offering (the "offering") to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). In connection with the offering, the Company expects to grant the initial purchasers an option to purchase up to an additional $60 million aggregate principal amount of notes.

    The final terms of the notes, including the initial conversion rate, interest rate and certain other terms, will be determined at the time of pricing. The notes will bear interest semi-annually and will mature on February 1, 2029, unless earlier converted, redeemed or repurchased. Prior to November 1, 2028, the notes will be convertible only upon satisfaction of certain conditions and during certain periods. Thereafter, the notes will be convertible at any time until the close of business on the second scheduled trading day immediately preceding the maturity date. The notes will be convertible at the option of the holders, subject to certain conditions and during certain periods, into cash, shares of the Company's common stock or a combination of cash and shares of the Company's common stock, with the form of consideration determined at the Company's election.

    The Company may not redeem the notes prior to February 6, 2026. On or after February 6, 2026 and on or before the 41st scheduled trading day immediately before the maturity date of the notes, the Company may redeem for cash all or any portion of the notes, at its option at any time, and from time to time, if the last reported sale price per share of the Company's common stock exceeds 130% of the conversion price for a specified period of time. The redemption price will be equal to 100% of the principal amount of the notes being redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. Holders of the notes will have the right to require the Company to repurchase all or a portion of their notes at 100% of their principal amount, plus any accrued and unpaid interest, upon the occurrence of certain events.

    When issued, the notes will be the Company's senior unsecured obligations and will rank senior in right of payment to any of the Company's unsecured indebtedness that is expressly subordinated in right of payment to the notes; equal in right of payment to any of the Company's unsecured indebtedness that is not so subordinated (including the Company's 2.50% Convertible Senior Notes due 2027); effectively junior in right of payment to any of the Company's secured indebtedness to the extent of the value of the assets securing such indebtedness; and structurally junior to all indebtedness and other liabilities (including trade payables) of the Company's subsidiaries.

    In connection with the pricing of the notes, the Company expects to enter into privately negotiated capped call transactions with one or more of the initial purchasers and/or their respective affiliates or other financial institutions (the "option counterparties"). These capped call transactions are expected generally to reduce the potential dilution to the Company's common stock upon any conversion of the notes and/or offset any cash payments the Company is required to make in excess of the principal amount of converted notes, as the case may be, with such reduction of potential dilution and/or offset of cash payments subject to a cap.

    The Company has been advised that, in connection with establishing their initial hedges of the capped call transactions, the option counterparties or their respective affiliates expect to enter into various derivative transactions with respect to the Company's common stock concurrently with or shortly after the pricing of the notes and/or purchase shares of the Company's common stock concurrently with or shortly after the pricing of the notes. This activity could increase (or reduce the size of any decrease in) the market price of the Company's common stock, the notes or the Company's 2.50% Convertible Senior Notes due 2027 at that time. In addition, the option counterparties or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to the Company's common stock and/or purchasing or selling the Company's common stock or other securities of the Company in secondary market transactions following the pricing of the notes and prior to maturity of the notes (and are likely to do so following any conversion of the notes, any redemption date or any repurchase of the notes by the Company on any fundamental change repurchase date or otherwise, in each case, if the Company exercises the relevant election under the capped call transactions). This activity could also cause or avoid an increase or a decrease in the market price of the Company's common stock or the notes, which could affect the ability of holders to convert the notes and, to the extent the activity occurs during any observation period related to a conversion of the notes, it could affect the number of shares of the Company's common stock, if any, and value of the consideration that holders will receive upon conversion of the notes.

    Further, if any such capped call transactions fail to become effective, whether or not the offering of notes is completed, the option counterparties or their respective affiliates may unwind their hedge positions with respect to the Company's common stock, which could adversely affect the value of the Company's common stock and, if the notes have been issued, the value of the notes.

    The Company intends to use a portion of the net proceeds from the offering of the notes to pay the cost of the capped call transactions, and up to approximately $50 million of the net proceeds from the offering to repurchase shares of its common stock from certain purchasers of the notes in privately negotiated transactions effected through one or more of the initial purchasers or an affiliate thereof concurrently with the pricing of the notes (such transactions, the "share repurchases"). If the initial purchasers exercise their option to purchase additional notes, the Company expects to use a portion of the net proceeds from the sale of such additional notes to enter into additional capped call transactions.

    The Company intends to use the remainder of the net proceeds from the offering for general corporate purposes, which may include research and development and clinical development costs to support the advancement of the Company's drug candidates, including the continued growth of the Company's commercial and medical affairs capabilities, the conduct of clinical trials and preclinical research and development activities; working capital; capital expenditures; repayment of outstanding indebtedness; general and administrative expenses; and other general corporate purposes. The Company may also use net proceeds to fund potential acquisitions of, or investments in, complementary businesses, products, services and technologies. The Company has not entered into any agreements or commitments with respect to any material acquisitions or investments at this time that would be financed with any of the net proceeds from the offering of notes. From time to time, to maintain or increase the Company's ownership position in its subsidiaries, the Company may make additional investments in or purchase equity in its subsidiaries. These expectations and intentions are subject to change.

    The Company expects the purchase price per share of its common stock in the share repurchases to equal the last reported sale price per share of its common stock on the Nasdaq Global Select Market as of the date of the pricing of the notes. The share repurchases could increase (or reduce the size of any decrease in) the market price of the Company's common stock prior to, concurrently with or shortly after the pricing of the notes, and could result in a higher effective conversion price for the notes.

    The notes and the shares of common stock issuable upon conversion of the notes, if any, are not being registered under the Securities Act, or the securities laws of any other jurisdiction. The notes and the shares of common stock issuable upon conversion of the notes, if any, may not be offered or sold in the United States except in transactions exempt from, or not subject to, the registration requirements of the Securities Act and any applicable state securities laws.

    This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

    About BridgeBio

    BridgeBio is a team of experienced drug discoverers, developers and innovators working to create life-altering medicines that target well-characterized genetic diseases at their source. BridgeBio was founded in 2015 to identify and advance transformative medicines to treat patients who suffer from Mendelian diseases, which are diseases that arise from defects in a single gene, and cancers with clear genetic drivers. BridgeBio's pipeline of over 20 development programs includes product candidates ranging from early discovery to late-stage development.

    Forward-Looking Statements

    This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), which are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements, including statements relating to whether we will offer and issue the notes, the terms of the notes, the anticipated use of the net proceeds from the offering and the expectations regarding the effect of the share repurchases and the capped call transactions and regarding actions of the option counterparties and their respective affiliates, and whether the capped call transactions will become effective, reflect our current views about our plans, intentions, expectations and strategies, which are based on the information currently available to us and on assumptions we have made.

    Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our Annual Report on Form 10-K for the year ended December 31, 2019, our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 and our other filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

    Contact:

    Grace Rauh

    BridgeBio Pharma, Inc.

    Grace.rauh@bridgebio.com

    (917) 232-5478

    Source: BridgeBio Pharma, Inc.



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  39. PALO ALTO, Calif. and SAN FRANCISCO, Jan. 19, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. ("BridgeBio") (NASDAQ:BBIO) and Eidos Therapeutics, Inc. ("Eidos") (NASDAQ:EIDX) today announced that the stockholders of each of BridgeBio and Eidos voted to approve all proposals related to BridgeBio's acquisition of all of the outstanding shares of Eidos common stock that BridgeBio does not already own. The merger is expected to close on or about January 26, 2021, subject to the satisfaction or waiver of other conditions to closing.

    At a special meeting of Eidos stockholders held virtually today, Eidos stockholders approved the adoption of the previously disclosed merger agreement with BridgeBio and each of the other proposals related to BridgeBio's…

    PALO ALTO, Calif. and SAN FRANCISCO, Jan. 19, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. ("BridgeBio") (NASDAQ:BBIO) and Eidos Therapeutics, Inc. ("Eidos") (NASDAQ:EIDX) today announced that the stockholders of each of BridgeBio and Eidos voted to approve all proposals related to BridgeBio's acquisition of all of the outstanding shares of Eidos common stock that BridgeBio does not already own. The merger is expected to close on or about January 26, 2021, subject to the satisfaction or waiver of other conditions to closing.

    At a special meeting of Eidos stockholders held virtually today, Eidos stockholders approved the adoption of the previously disclosed merger agreement with BridgeBio and each of the other proposals related to BridgeBio's proposed acquisition of Eidos.

    At a special meeting of BridgeBio stockholders held virtually today, BridgeBio stockholders approved the proposal to issue common stock to Eidos stockholders in connection with the proposed acquisition.

    "We are ready and eager to welcome Eidos back into BridgeBio's ecosystem of scientific innovation," said Neil Kumar, Ph.D., founder and CEO of BridgeBio and CEO of Eidos. "We believe this merger will allow us to fully unlock the potential of acoramidis, the investigational therapy Eidos is developing to target transthyretin (TTR) amyloidosis (ATTR), creating value for patients and investors. I'd like to thank BridgeBio and Eidos stockholders for their support and their overwhelming approval of this transaction."

    Holders of Eidos common stock may elect to receive, for each share of Eidos common stock issued and outstanding immediately prior to the effective time of the merger (the "Effective Time") that is not owned by BridgeBio or any of its subsidiaries and that is not a restricted share award, either (1) 1.85 shares of common stock of BridgeBio (the "Stock Consideration") or (2) $73.26 in cash (the "Cash Consideration" and, together with the Stock Consideration, the "Merger Consideration"), subject to proration. The Cash Consideration will be prorated as necessary to ensure that the aggregate amount of cash consideration payable in the merger is no greater than $175 million. Any Eidos stockholders who do not make a proper election by 5:00 p.m., New York City time, on January 21, 2021 will be deemed to have elected to receive the Stock Consideration for their shares of Eidos common stock.

    About BridgeBio Pharma

    BridgeBio Pharma is a team of experienced drug discoverers, developers and innovators working to create life-altering medicines that target well-characterized genetic diseases at their source. BridgeBio was founded in 2015 to identify and advance transformative medicines to treat patients who suffer from Mendelian diseases, which are diseases that arise from defects in a single gene, and cancers with clear genetic drivers. BridgeBio's pipeline of over 20 development programs includes product candidates ranging from early discovery to late-stage development. For more information visit www.bridgebio.com.

    About Eidos Therapeutics

    Eidos Therapeutics is a clinical stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin (TTR) amyloidosis (ATTR). Eidos is developing acoramidis, a potentially disease-modifying therapy for the treatment of ATTR. For more information, visit www.eidostx.com.

    Additional Information and Where to Find It

    This press release is being made in respect of the proposed transaction involving BridgeBio and Eidos, which was submitted to BridgeBio's and Eidos' stockholders for their consideration. BridgeBio and Eidos have each filed relevant materials with the U.S. Securities and Exchange Commission (the "SEC"), including a registration statement on Form S-4 (Registration No. 333-249944) that includes a proxy statement of BridgeBio and Eidos, and that also constitutes a prospectus of BridgeBio (the "Joint Proxy Statement/Prospectus"), that was mailed or otherwise provided to BridgeBio and Eidos stockholders on or about December 15, 2020.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval. This press release is not intended to be, and is not, a substitute for such filings or for any other document that BridgeBio or Eidos may file with the SEC in connection with the proposed transaction. INVESTORS AND SECURITY HOLDERS ARE URGED TO CAREFULLY READ THE ENTIRE REGISTRATION STATEMENT, JOINT PROXY STATEMENT/PROSPECTUS, AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. The documents filed or furnished by BridgeBio and Eidos with the SEC may be obtained free of charge at the SEC's website at www.sec.gov. In addition, the documents filed by BridgeBio may be obtained free of charge from BridgeBio at investor.bridgebio.com, under the tab "Financials & Filings," and the documents filed by Eidos may be obtained free of charge from Eidos at www.eidostx.com, under the tab "Investors." Alternatively, these documents, when available, can be obtained free of charge from BridgeBio upon written request to BridgeBio at 421 Kipling Street, Palo Alto, CA 94301, Attn: Investor Relations, or by calling 650-391-9740, or from Eidos upon written request to Eidos at 101 Montgomery Street, Suite 2000, San Francisco, CA 94104, Attn: Investor Relations, or by calling 415-887-1471.

    No Offer or Solicitation

    This press release is not intended to and does not constitute an offer to sell or the solicitation of an offer to buy, sell or solicit any securities or any proxy, vote or approval in any jurisdiction pursuant to or in connection with the proposed transaction or otherwise, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offer of securities shall be deemed to be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended (the "Securities Act").

    Forward-Looking Statements

    This press release contains forward-looking statements relating to the proposed transaction involving BridgeBio and Eidos, including financial estimates and statements as to the expected timing, completion and effects of the proposed transaction. Statements in this press release that are not statements of historical fact are considered forward-looking statements within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), which are usually identified by the use of words such as "anticipates," "believes," "continues", "could", "estimates," "expects," "intends," "may," "plans," "potential", "predicts", "projects," "seeks," "should," "will," and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements are neither forecasts, promises nor guarantees, and are based on the current beliefs of BridgeBio's management as well as assumptions made by and information currently available to BridgeBio. Such statements reflect the current views of BridgeBio with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about BridgeBio and Eidos, including, without limitation, (i) the occurrence of any event, change or other circumstances that could give rise to the termination of the proposed transaction, (ii) inability to complete the proposed transaction because, among other reasons, conditions to the closing of the proposed transaction may not be satisfied or waived, (iii) uncertainty as to the timing of completion of the proposed transaction, (iv) potential adverse effects or changes to relationships with customers, employees, suppliers or other parties resulting from the announcement or completion of the proposed transaction, (v) potential litigation relating to the proposed transaction that could be instituted against BridgeBio, Eidos or their respective directors and officers, including the effects of any outcomes related thereto, (vi) possible disruptions from the proposed transaction that could harm BridgeBio's or Eidos' respective business, including current plans and operations, (vii) unexpected costs, charges or expenses resulting from the proposed transaction, (viii) uncertainty of the expected financial performance of each of BridgeBio and Eidos following completion of the proposed transaction, including the possibility that the expected synergies and value creation from the proposed transaction will not be realized or will not be realized within the expected time period, (ix) the ability of BridgeBio and/or Eidos to implement their respective business strategies, (x) the ability of each of BridgeBio or Eidos to continue its planned preclinical and clinical development of its respective development programs, and the timing and success of any such continued preclinical and clinical development and planned regulatory submissions, (xi) the potential therapeutic and clinical benefits of acoramidis, (xii) inability to retain and hire key personnel, (xiii) the amount of proposed stock consideration in the transaction and (xiv) the unknown future impact of the COVID-19 pandemic delay on certain clinical trial milestones and/or BridgeBio's or Eidos' operations or operating expenses. Although BridgeBio believes that BridgeBio's and Eidos' plans, intentions, expectations, strategies and prospects as reflected in or suggested by these forward-looking statements are reasonable, BridgeBio cannot give any assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, without limitation, those risks and uncertainties described under the heading "Risk Factors" in BridgeBio's most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K filed with the SEC and in subsequent filings made by BridgeBio with the SEC, which are available on the SEC's website at www.sec.gov. Moreover, BridgeBio operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of BridgeBio's management as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. We anticipate that subsequent events and developments will cause our views to change. Except as required by law, BridgeBio disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.

    Contact:

    Grace Rauh

    BridgeBio Pharma, Inc.

    grace.rauh@bridgebio.com

    917-232-5478



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  40. PALO ALTO, Calif. and SAN FRANCISCO, Jan. 13, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. ("BridgeBio") (NASDAQ:BBIO) and Eidos Therapeutics, Inc. ("Eidos") (NASDAQ:EIDX) announced today that the acquisition of shares of common stock of Eidos not held by BridgeBio or its subsidiaries, on the terms and subject to the conditions of their previously announced merger agreement, is expected to close on or about January 26, 2021. The closing of the transaction is subject to the receipt of approvals from BridgeBio and Eidos stockholders at special meetings of each company's stockholders, both of which are scheduled for January 19, 2021, and the satisfaction or waiver of other conditions to closing. Leading proxy advisory firms Institutional Shareholder…

    PALO ALTO, Calif. and SAN FRANCISCO, Jan. 13, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. ("BridgeBio") (NASDAQ:BBIO) and Eidos Therapeutics, Inc. ("Eidos") (NASDAQ:EIDX) announced today that the acquisition of shares of common stock of Eidos not held by BridgeBio or its subsidiaries, on the terms and subject to the conditions of their previously announced merger agreement, is expected to close on or about January 26, 2021. The closing of the transaction is subject to the receipt of approvals from BridgeBio and Eidos stockholders at special meetings of each company's stockholders, both of which are scheduled for January 19, 2021, and the satisfaction or waiver of other conditions to closing. Leading proxy advisory firms Institutional Shareholder Services and Glass Lewis recommend that BridgeBio and Eidos stockholders vote "FOR" BridgeBio's proposed merger with Eidos and each of the other proposals to be considered at both companies' virtual special meetings.

    The election deadline for holders of Eidos common stock to elect the form of consideration they wish to receive in the merger will be at 5:00 p.m., New York City time, on January 21, 2021 (the "Election Deadline"), unless extended. The Election Form and Letter of Transmittal (the "Election Form") necessary for Eidos stockholders to make an election as to the form of consideration they wish to receive was mailed on December 16, 2020 to holders of record of Eidos common stock as of the close of business on December 8, 2020.

    Holders of Eidos common stock may elect to receive, for each share of Eidos common stock issued and outstanding immediately prior to the effective time of the merger (the "Effective Time") that is not owned by BridgeBio or any of its subsidiaries and that is not a restricted share award, either (1) 1.85 shares of common stock of BridgeBio (the "Stock Consideration") or (2) $73.26 in cash (the "Cash Consideration" and, together with the Stock Consideration, the "Merger Consideration"), subject to proration. The Cash Consideration will be prorated as necessary to ensure that the aggregate amount of cash consideration payable in the merger is no greater than $175 million.

    As further described in the election materials, in order to make an election, Eidos stockholders must deliver to American Stock Transfer & Trust Company, LLC, the exchange agent in the merger, prior to the Election Deadline, a properly executed Election Form together with any other required documents described in the election materials. Eidos stockholders who hold their shares of Eidos common stock in "street name" through a bank, broker or other nominee, should follow the instructions of the bank, broker or other nominee for making an election with respect to their shares. Such stockholders' bank, broker or other nominee, as applicable, may have an earlier deadline by which they must provide instructions to it in order to make an election with respect to their shares.

    The submission of an Election Form does NOT constitute a vote for the adoption of the merger agreement. In order to vote their shares of Eidos common stock with respect to the adoption of the merger agreement, Eidos stockholders must follow the instructions for voting described in the joint proxy statement/prospectus dated December 15, 2020, which was first mailed to Eidos stockholders on or about December 15, 2020 (the "Joint Proxy Statement/Prospectus"), and the accompanying proxy materials.

    Any Eidos stockholders who do not make a proper election by the Election Deadline will be deemed to have elected to receive the Stock Consideration for their shares of Eidos common stock. If the closing is delayed to a subsequent date, the Election Deadline will be similarly delayed to a subsequent date, and BridgeBio and Eidos will promptly announce any such delay or rescheduling.

    Eidos stockholders who have questions regarding the election procedures or who wish to obtain copies of the Joint Proxy Statement/Prospectus, Election Form and other election materials, should contact Morrow Sodali LLC, the information agent for the election process, by calling toll-free at (800) 662-5200 (in North America) or (203) 658-9400 (outside North America).

    About BridgeBio Pharma

    BridgeBio Pharma is a team of experienced drug discoverers, developers and innovators working to create life-altering medicines that target well-characterized genetic diseases at their source. BridgeBio was founded in 2015 to identify and advance transformative medicines to treat patients who suffer from Mendelian diseases, which are diseases that arise from defects in a single gene, and cancers with clear genetic drivers. BridgeBio's pipeline of over 20 development programs includes product candidates ranging from early discovery to late-stage development. For more information visit www.bridgebio.com.

    About Eidos Therapeutics

    Eidos Therapeutics is a clinical stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin (TTR) amyloidosis (ATTR). Eidos is developing acoramidis, a potentially disease-modifying therapy for the treatment of ATTR. For more information, visit www.eidostx.com.

    Additional Information and Where to Find It

    This press release is being made in respect of the proposed transaction involving BridgeBio and Eidos, which will be submitted to BridgeBio's and Eidos' stockholders for their consideration. BridgeBio and Eidos have each filed relevant materials with the U.S. Securities and Exchange Commission (the "SEC"), including the Joint Proxy Statement/Prospectus. On December 15, 2020, the SEC declared the Joint Proxy Statement/Prospectus effective. BridgeBio and Eidos mailed or otherwise provided to their respective stockholders the Joint Proxy Statement/Prospectus regarding the proposed transaction involving BridgeBio and Eidos on or about December 15, 2020.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval. This press release is not intended to be, and is not, a substitute for such filings or for any other document that BridgeBio or Eidos may file with the SEC in connection with the proposed transaction. BEFORE MAKING ANY VOTING OR INVESTMENT DECISION, INVESTORS AND SECURITY HOLDERS ARE URGED TO CAREFULLY READ THE ENTIRE REGISTRATION STATEMENT, JOINT PROXY STATEMENT/PROSPECTUS, AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. The documents filed or furnished by BridgeBio and Eidos with the SEC may be obtained free of charge at the SEC's website at www.sec.gov. In addition, the documents filed by BridgeBio may be obtained free of charge from BridgeBio at investor.bridgebio.com, under the tab "Financials & Filings," and the documents filed by Eidos may be obtained free of charge from Eidos at www.eidostx.com, under the tab "Investors." Alternatively, these documents, when available, can be obtained free of charge from BridgeBio upon written request to BridgeBio at 421 Kipling Street, Palo Alto, CA 94301, Attn: Investor Relations, or by calling 650-391-9740, or from Eidos upon written request to Eidos at 101 Montgomery Street, Suite 2000, San Francisco, CA 94104, Attn: Investor Relations, or by calling 415-887-1471.

    Participants in the Solicitation

    BridgeBio, Eidos and certain of their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from stockholders of Eidos in connection with the proposed transaction under the rules of the SEC. Investors may obtain information regarding the names, affiliations and interests of directors and executive officers of BridgeBio in BridgeBio's proxy statement for its 2020 annual meeting of stockholders, which was filed with the SEC on April 22, 2020, as well as its other filings with the SEC. Investors may obtain information regarding the names, affiliations and interests of Eidos' directors and executive officers in Eidos' proxy statement for its 2020 annual meeting of stockholders, which was filed with the SEC on April 24, 2020, and the Joint Proxy Statement/Prospectus, as well as its other filings with the SEC. Other information regarding the participants in the proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, are included in the Joint Proxy Statement/Prospectus and other relevant materials filed with the SEC regarding the proposed transaction. You may obtain free copies of these documents at the SEC's website at www.sec.gov. Copies of documents filed with the SEC by BridgeBio and Eidos are also available free of charge from BridgeBio or Eidos, as applicable, using the contact information above.

    No Offer or Solicitation

    This press release is not intended to and does not constitute an offer to sell or the solicitation of an offer to buy, sell or solicit any securities or any proxy, vote or approval in any jurisdiction pursuant to or in connection with the proposed transaction or otherwise, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offer of securities shall be deemed to be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended (the "Securities Act").

    Forward-Looking Statements

    This press release contains forward-looking statements relating to the proposed transaction involving BridgeBio and Eidos, including financial estimates and statements as to the expected timing, completion and effects of the proposed transaction. Statements in this press release that are not statements of historical fact are considered forward-looking statements within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), which are usually identified by the use of words such as "anticipates," "believes," "continues", "could", "estimates," "expects," "intends," "may," "plans," "potential", "predicts", "projects," "seeks," "should," "will," and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements are neither forecasts, promises nor guarantees, and are based on the current beliefs of BridgeBio's management as well as assumptions made by and information currently available to BridgeBio. Such statements reflect the current views of BridgeBio with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about BridgeBio and Eidos, including, without limitation, (i) the occurrence of any event, change or other circumstances that could give rise to the termination of the proposed transaction, (ii) the risk that BridgeBio's and/or Eidos' stockholders may not approve the proposed transaction, (iii) inability to complete the proposed transaction because, among other reasons, conditions to the closing of the proposed transaction may not be satisfied or waived, (iv) uncertainty as to the timing of completion of the proposed transaction, (v) potential adverse effects or changes to relationships with customers, employees, suppliers or other parties resulting from the announcement or completion of the proposed transaction, (vi) potential litigation relating to the proposed transaction that could be instituted against BridgeBio, Eidos or their respective directors and officers, including the effects of any outcomes related thereto, (vii) possible disruptions from the proposed transaction that could harm BridgeBio's or Eidos' respective business, including current plans and operations, (viii) unexpected costs, charges or expenses resulting from the proposed transaction, (ix) uncertainty of the expected financial performance of each of BridgeBio and Eidos following completion of the proposed transaction, including the possibility that the expected synergies and value creation from the proposed transaction will not be realized or will not be realized within the expected time period, (x) the ability of BridgeBio and/or Eidos to implement their respective business strategies, (xi) the ability of each of BridgeBio or Eidos to continue its planned preclinical and clinical development of its respective development programs, and the timing and success of any such continued preclinical and clinical development and planned regulatory submissions, (xii) the potential therapeutic and clinical benefits of acoramidis, (xiii) inability to retain and hire key personnel, (xiv) the amount of proposed stock consideration in the transaction and (xv) the unknown future impact of the COVID-19 pandemic delay on certain clinical trial milestones and/or BridgeBio's or Eidos' operations or operating expenses. Although BridgeBio believes that BridgeBio's and Eidos' plans, intentions, expectations, strategies and prospects as reflected in or suggested by these forward-looking statements are reasonable, BridgeBio cannot give any assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, without limitation, those risks and uncertainties described under the heading "Risk Factors" in BridgeBio's most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K filed with the SEC and in subsequent filings made by BridgeBio with the SEC, which are available on the SEC's website at www.sec.gov. Moreover, BridgeBio operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of BridgeBio's management as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. We anticipate that subsequent events and developments will cause our views to change. Except as required by law, BridgeBio disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.

    Contact:

    Grace Rauh

    BridgeBio Pharma, Inc.

    grace.rauh@bridgebio.com

    917-232-5478



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  41. PALO ALTO, Calif., Jan. 06, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a clinical-stage biopharmaceutical company focused on genetic diseases, today announced that on January 4, 2021, the compensation committee of BridgeBio's board of directors granted six new employees restricted stock units for an aggregate of 4,126 shares of the Company's common stock. All of the above-described awards were made under BridgeBio's 2019 Inducement Equity Plan (the Plan).

    The above-described awards were each granted as an inducement material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4), and were granted pursuant to the terms of the Plan. The Plan was adopted by BridgeBio's…

    PALO ALTO, Calif., Jan. 06, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a clinical-stage biopharmaceutical company focused on genetic diseases, today announced that on January 4, 2021, the compensation committee of BridgeBio's board of directors granted six new employees restricted stock units for an aggregate of 4,126 shares of the Company's common stock. All of the above-described awards were made under BridgeBio's 2019 Inducement Equity Plan (the Plan).

    The above-described awards were each granted as an inducement material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4), and were granted pursuant to the terms of the Plan. The Plan was adopted by BridgeBio's board of directors in November 2019.

    About BridgeBio

    BridgeBio a team of experienced drug discoverers, developers and innovators working to create life-altering medicines that target well-characterized genetic diseases at their source. BridgeBio was founded in 2015 to identify and advance transformative medicines to treat patients who suffer from Mendelian diseases, which are diseases that arise from defects in a single gene, and cancers with clear genetic drivers. BridgeBio's pipeline of over 20 development programs includes product candidates ranging from early discovery to late-stage development.

    Media Contact:

    Grace Rauh

    Grace.rauh@bridgebio.com 

    (917) 232-5478

    Investor Contact:

    John Grimaldi, Burns McClellan

    jgrimaldi@burnsmc.com 

    212-213-0006 ext. 362

    Source: BridgeBio Pharma, Inc.

     



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  42. PALO ALTO, Calif., Jan. 04, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) today announced that leading proxy advisory firm Institutional Shareholder Services ("ISS") recommends that BridgeBio stockholders and Eidos Therapeutics, Inc. (NASDAQ:EIDX) stockholders vote "FOR" BridgeBio's proposed merger with Eidos and each of the other proposals to be considered at both companies' virtual special meetings to be held on January 19, 2021. 

    Under the proposed merger agreement, BridgeBio has agreed to acquire all of the outstanding common stock of Eidos it does not already own, representing approximately 36.3% of Eidos' outstanding shares. Eidos stockholders will have the right to receive in the transaction, at their election, either…

    PALO ALTO, Calif., Jan. 04, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) today announced that leading proxy advisory firm Institutional Shareholder Services ("ISS") recommends that BridgeBio stockholders and Eidos Therapeutics, Inc. (NASDAQ:EIDX) stockholders vote "FOR" BridgeBio's proposed merger with Eidos and each of the other proposals to be considered at both companies' virtual special meetings to be held on January 19, 2021. 

    Under the proposed merger agreement, BridgeBio has agreed to acquire all of the outstanding common stock of Eidos it does not already own, representing approximately 36.3% of Eidos' outstanding shares. Eidos stockholders will have the right to receive in the transaction, at their election, either 1.85 shares of BridgeBio common stock or $73.26 in cash per Eidos share in the transaction, up to an aggregate maximum of $175 million of cash. Based on the closing price of $71.11 per share of BridgeBio common stock on the Nasdaq on December 31, 2020, the stock consideration represented approximately $131.55 per share of Eidos common stock.

    The BridgeBio board of directors unanimously recommends that BridgeBio stockholders vote "FOR" the proposal to approve the issuance of BridgeBio shares in connection with the merger agreement.

    In light of the fact that BridgeBio owns a majority of the issued and outstanding Eidos common stock and certain BridgeBio officers and directors also serve on the Eidos board, the Eidos board formed a special committee of independent directors (the "Eidos special committee") to consider and negotiate the terms and conditions of the merger and to make a recommendation to the Eidos board. The Eidos special committee recommends that Eidos stockholders vote "FOR" the proposal to approve the merger with BridgeBio as well as additional proposals to be considered at the Eidos special meeting.

    The merger is expected to be consummated by the end of the first calendar quarter of 2021, subject to the receipt of the required approvals from both BridgeBio and Eidos stockholders and other customary closing conditions. Following the consummation of the merger, Eidos will become a wholly owned subsidiary of BridgeBio and Eidos' common stock will no longer be listed on any public market.

    About BridgeBio Pharma

    BridgeBio Pharma is a team of experienced drug discoverers, developers and innovators working to create life-altering medicines that target well-characterized genetic diseases at their source. BridgeBio was founded in 2015 to identify and advance transformative medicines to treat patients who suffer from Mendelian diseases, which are diseases that arise from defects in a single gene, and cancers with clear genetic drivers. BridgeBio's pipeline of over 20 development programs includes product candidates ranging from early discovery to late-stage development. For more information visit www.bridgebio.com.

    About Eidos Therapeutics

    Eidos Therapeutics is a clinical stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin (TTR) amyloidosis (ATTR). Eidos is developing acoramidis, a potentially disease-modifying therapy for the treatment of ATTR. For more information, visit www.eidostx.com.

    Additional Information and Where to Find It:

    This communication is being made in respect of the proposed transaction involving BridgeBio and Eidos, which will be submitted to BridgeBio's and Eidos' stockholders for their consideration. BridgeBio and Eidos have each filed relevant materials with the SEC, including a registration statement on Form S-4 (Registration No. 333-249944) that includes a proxy statement of BridgeBio and Eidos, and that also constitutes a prospectus of BridgeBio (the "definitive joint proxy statement/prospectus").  On December 15, 2020, the SEC declared the registration statement effective. BridgeBio and Eidos mailed or otherwise provided to their respective stockholders the definitive joint proxy statement/prospectus regarding the proposed transaction involving BridgeBio and Eidos on or about December 15, 2020. 

    This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval. This press release is not intended to be, and is not, a substitute for such filings or for any other document that BridgeBio or Eidos may file with the SEC in connection with the proposed transaction.  Before making any voting or investment decision, investors and security holders are urged to carefully read the entire registration statement, definitive joint proxy statement/prospectus, and any other relevant documents filed with the SEC, as well as any amendments or supplements to these documents, CAREFULLY AND IN THEIR ENTIRETY because they will contain important information about the proposed transaction. The documents filed or furnished by BridgeBio and Eidos with the SEC may be obtained free of charge at the SEC's website at www.sec.gov. In addition, the documents filed by BridgeBio may be obtained free of charge from BridgeBio at investor.bridgebio.com, under the tab "Financials & Filings," and the documents filed by Eidos may be obtained free of charge from Eidos at www.eidostx.com, under the tab "Investors." Alternatively, these documents, when available, can be obtained free of charge from BridgeBio upon written request to BridgeBio Pharma at 421 Kipling Street, Palo Alto, CA 94301, Attn: Investor Relations, or by calling 650-391-9740, or from Eidos upon written request to Eidos at 101 Montgomery Street, Suite 2000, San Francisco, CA 94104, Attn: Investor Relations, or by calling 415-887-1471.

    Participants in the Solicitation

    BridgeBio, Eidos and certain of their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from stockholders of Eidos in connection with the proposed transaction under the rules of the SEC. Investors may obtain information regarding the names, affiliations and interests of directors and executive officers of BridgeBio in BridgeBio's proxy statement for its 2020 annual meeting of stockholders, which was filed with the SEC on April 22, 2020, as well as its other filings with the SEC. Investors may obtain information regarding the names, affiliations and interests of Eidos' directors and executive officers in Eidos' proxy statement for its 2020 annual meeting of stockholders, which was filed with the SEC on April 24, 2020, and the definitive joint proxy statement/prospectus, which was filed with the SEC on December 15, 2020, as well as its other filings with the SEC. Other information regarding the participants in the proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, are included in the definitive joint proxy statement/prospectus and other relevant materials filed with the SEC regarding the proposed transaction. You may obtain free copies of these documents at the SEC's website at www.sec.gov. Copies of documents filed with the SEC by BridgeBio and Eidos are also available free of charge from BridgeBio or Eidos, as applicable, using the contact information above.

    No Offer or Solicitation

    This material is not intended to and does not constitute an offer to sell or the solicitation of an offer to buy, sell or solicit any securities or any proxy, vote or approval in any jurisdiction pursuant to or in connection with the proposed transaction or otherwise, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offer of securities shall be deemed to be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended (the "Securities Act").

    Forward-Looking Statements:

    This press release contains forward-looking statements relating to the proposed transaction involving BridgeBio and Eidos, including financial estimates and statements as to the expected timing, completion and effects of the proposed transaction. Statements in this press release that are not statements of historical fact are considered forward-looking statements within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), which are usually identified by the use of words such as "anticipates," "believes," "continues", "could", "estimates," "expects," "intends," "may," "plans," "potential", "predicts", "projects," "seeks," "should," "will," and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements are neither forecasts, promises nor guarantees, and are based on the current beliefs of BridgeBio's management as well as assumptions made by and information currently available to BridgeBio. Such statements reflect the current views of BridgeBio with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about BridgeBio and Eidos, including, without limitation, (i) the occurrence of any event, change or other circumstances that could give rise to the termination of the proposed transaction, (ii) the risk that BridgeBio's and/or Eidos' stockholders may not approve the proposed transaction, (iii) inability to complete the proposed transaction because, among other reasons, conditions to the closing of the proposed transaction may not be satisfied or waived, (iv) uncertainty as to the timing of completion of the proposed transaction, (v) potential adverse effects or changes to relationships with customers, employees, suppliers or other parties resulting from the announcement or completion of the proposed transaction, (vi) potential litigation relating to the proposed transaction that could be instituted against BridgeBio, Eidos or their respective directors and officers, including the effects of any outcomes related thereto, (vii) possible disruptions from the proposed transaction that could harm BridgeBio's or Eidos' respective business, including current plans and operations, (viii) unexpected costs, charges or expenses resulting from the proposed transaction, (ix) uncertainty of the expected financial performance of each of BridgeBio and Eidos following completion of the proposed transaction, including the possibility that the expected synergies and value creation from the proposed transaction will not be realized or will not be realized within the expected time period, (x) the ability of BridgeBio and/or Eidos to implement their respective business strategies, (xi) the ability of each of BridgeBio or Eidos to continue its planned preclinical and clinical development of its respective development programs, and the timing and success of any such continued preclinical and clinical development and planned regulatory submissions, (xii) the potential therapeutic and clinical benefits of acoramidis, (xiii) inability to retain and hire key personnel, (xiv) the amount of proposed stock consideration in the transaction and (xv) the unknown future impact of the COVID-19 pandemic delay on certain clinical trial milestones and/or BridgeBio's or Eidos' operations or operating expenses. Although BridgeBio believes that BridgeBio's and Eidos' plans, intentions, expectations, strategies and prospects as reflected in or suggested by these forward-looking statements are reasonable, BridgeBio cannot give any assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, without limitation, those risks and uncertainties described under the heading "Risk Factors" in BridgeBio's most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K filed with the SEC and in subsequent filings made by BridgeBio with the SEC, which are available on the SEC's website at www.sec.gov. Moreover, BridgeBio operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of BridgeBio's management as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. We anticipate that subsequent events and developments will cause our views to change.  Except as required by law, BridgeBio disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise.  You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.

    Contact:

    Grace Rauh

    BridgeBio Pharma, Inc.

    grace.rauh@bridgebio.com

    917-232-5478

    Source: BridgeBio Pharma, Inc.



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  43. SAN FRANCISCO, Dec. 23, 2020 (GLOBE NEWSWIRE) -- UC San Francisco (UCSF) and BridgeBio Pharma, Inc. (NASDAQ:BBIO) today announced a partnership to drive the advancement of academic innovations in genetically driven diseases into potential therapeutics for patients.

    "The BridgeBio team is developing close relationships with our investigators at UCSF with the mission of bringing potential therapies into the clinic quickly, where they have the opportunity to help patients in need," said Barry Selick, Ph.D., UCSF vice chancellor for business development, innovation and partnerships and director of the Office of Innovation Ventures. "We are excited about this partnership and the opportunities it may create for the development of new medicines…

    SAN FRANCISCO, Dec. 23, 2020 (GLOBE NEWSWIRE) -- UC San Francisco (UCSF) and BridgeBio Pharma, Inc. (NASDAQ:BBIO) today announced a partnership to drive the advancement of academic innovations in genetically driven diseases into potential therapeutics for patients.

    "The BridgeBio team is developing close relationships with our investigators at UCSF with the mission of bringing potential therapies into the clinic quickly, where they have the opportunity to help patients in need," said Barry Selick, Ph.D., UCSF vice chancellor for business development, innovation and partnerships and director of the Office of Innovation Ventures. "We are excited about this partnership and the opportunities it may create for the development of new medicines."



    "UCSF is a global leader in scientific innovation and genetic disease research, and we are proud to establish a formal, long-term relationship with the university as we work to help patients as quickly and safely as possible," said BridgeBio CEO and founder Neil Kumar, Ph.D.



    Following a six-month pilot collaboration, the new agreement establishes a three-year alliance with BridgeBio with the goal of identifying early translational research to accelerate into clinical development and potential commercialization. The partnership is designed to foster close collaboration between the two entities that build on their respective strengths, and it will initially be structured to enable Sponsored Research Agreements for certain labs working between UCSF Innovation Ventures and BridgeBio. These collaborations may lead to the creation of BridgeBio affiliate companies to support clinical development.

    "Collaborative relationships between academia--which has a wealth of scientific knowledge in a range of overlooked diseases--and industry, with its robust development infrastructure, are truly valuable and can help leapfrog traditional R&D timelines," said Frank McCormick, Ph.D., F.R.S., a professor in the Helen Diller Family Comprehensive Cancer Center at UCSF and co-founder and chairman of oncology at BridgeBio. "I hope this partnership will allow people living with genetically driven disorders to access therapeutic options much more quickly and effectively."

    About UCSF: 



    The University of California, San Francisco (UCSF) is exclusively focused on the health sciences and is dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It includes UCSF Health, which comprises three top-ranked hospitals, as well as affiliations throughout the Bay Area. Learn more at ucsf.eduor see our Fact Sheet.

    About BridgeBio Pharma:



    BridgeBio is a team of experienced drug discoverers, developers and innovators working to create life-altering medicines that target well-characterized genetic diseases at their source. BridgeBio was founded in 2015 to identify and advance transformative medicines to treat patients who suffer from Mendelian diseases, which are diseases that arise from defects in a single gene, and cancers with clear genetic drivers. BridgeBio's pipeline of over 20 development programs includes product candidates ranging from early discovery to late-stage development. For more information, please visit bridgebio.com.

    BridgeBio Pharma Forward-Looking Statements:

    This press release contains forward-looking statements. Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), which are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions.  We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions.  These forward-looking statements, including statements relating to expectations, plans, and prospects regarding our ability to build on UCSF's scientific innovation and genetic disease research and translate them into meaningful medicines for patients in need, the success of current and future relationships with third-party collaborators and academic partners, and the potential ability of our product candidates to treat genetically driven diseases and cancers with clear genetic drivers, reflect our current views about our plans, intentions, expectations, strategies and prospects, and are based on the information currently available to us and on assumptions we have made and are not forecasts, promises nor guarantees. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by these forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved.  Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, the success of our product candidates to treat genetically driven diseases and cancers with clear genetic drivers, the success of our collaboration with UCSF, as well as those risks set forth in the Risk Factors section of BridgeBio Pharma's most recent Quarterly Report on Form 10-Q and BridgeBio Pharma's other SEC filings. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

    UCSF Contact: Nicholas Weiler | (650) 733-6955 | nicholas.weiler@ucsf.edu

    BridgeBio Contact: Grace Rauh | (917) 232-5478 | grace.rauh@bridgebio.com 

    Follow UCSF

    ucsf.edu | Facebook.com/ucsf | Twitter.com/ucsf | YouTube.com/ucsf



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  44. Contour Therapeutics Brings Together Leaders with Extensive Cardiovascular, Genetics and Drug Development Expertise

    Partnership Focused on Delivering Targeted Therapies for Genetically Defined Cardiovascular Diseases

    PALO ALTO, Calif. and SOUTH SAN FRANCISCO, Calif., Dec. 07, 2020 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) and Maze Therapeutics today announced the establishment of a joint venture, Contour Therapeutics, focused on transforming and advancing breakthrough precision medicine approaches designed to treat cardiovascular disease, the leading cause of death worldwide.

    This joint venture between two leading biotech companies unites Maze's genetically driven approach to drug discovery, as well as insights…

    Contour Therapeutics Brings Together Leaders with Extensive Cardiovascular, Genetics and Drug Development Expertise

    Partnership Focused on Delivering Targeted Therapies for Genetically Defined Cardiovascular Diseases

    PALO ALTO, Calif. and SOUTH SAN FRANCISCO, Calif., Dec. 07, 2020 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) and Maze Therapeutics today announced the establishment of a joint venture, Contour Therapeutics, focused on transforming and advancing breakthrough precision medicine approaches designed to treat cardiovascular disease, the leading cause of death worldwide.

    This joint venture between two leading biotech companies unites Maze's genetically driven approach to drug discovery, as well as insights from its COMPASS platform, with BridgeBio's expertise in cardiac drug discovery and clinical development. Together, the companies will focus on advancing genetically validated therapeutic candidates through clinical development and will initially work on the development of a treatment for patients with an undisclosed, genetically defined form of heart failure.

    The new partnership builds on exciting progress underway to identify and target genetic causes of cardiovascular diseases, including BridgeBio's precision medicine approach at its affiliate Eidos Therapeutics designed to treat transthyretin amyloidosis, an underdiagnosed and life-threatening cause of heart failure. The partnership also builds on seminal advances in the treatment of inherited cardiomyopathies, including at MyoKardia, a company co-founded by senior leaders at BridgeBio and Maze.

    "Cardiovascular disease is a deadly and widespread health problem across the world, but unfortunately, innovations in new treatment approaches have been limited," said Jason Coloma, Ph.D., CEO of Maze. "Since we launched Maze, we have been focused on the advancement of our COMPASS platform, on which we've made important progress and gained confidence in the genetics we are focused on, as well as novel insights into how to best develop therapies for patients with cardiovascular disease. We are excited to join forces with BridgeBio, combining the unique talents and expertise across our respective teams, in order to deliver a profound impact on how these diseases are treated in the future."

    "We are privileged to be partnering with and learning from Maze. We are eager to build on BridgeBio's work in precision medicine to treat cardiovascular disease, and we believe our joint venture with Maze holds great promise for patients as we bring together innovative leaders in cardiology and genetics," said Neil Kumar, Ph.D., founder and CEO of BridgeBio. "The identification and targeting of genetically defined patient populations has created elegant and clinically meaningful medicines in oncology and other therapeutic areas. We feel strongly that one of the next frontiers in precision medicine lies in helping people suffering from cardiovascular disease, and we are excited to be on the front lines of advances in this field."

    "This partnership between Maze and BridgeBio will bring together many of the people who helped found and build revolutionary companies in cardiovascular drug development," said Charles Homcy, M.D., chairman of the Maze board of directors and lead director and chairman of pharmaceuticals of BridgeBio. "With the combined expertise of these teams, we have an opportunity to create something special that has a profound impact on how patients with cardiovascular disease are treated in the future."

    About the Maze COMPASS Platform

    The Maze COMPASS platform combines human genetics, functional genomics and data science to identify and prioritize drug targets for both rare and common diseases, validate drug targets and inform target tractability and clinical development. Maze aims to leverage COMPASS to translate a wealth of genetic opportunities generated by the platform into new therapeutics.

    About Maze Therapeutics

    Maze Therapeutics is a biopharmaceutical company developing a broad portfolio of therapeutic candidates for a number of genetically defined diseases. Maze is focused on translating genetic insights into new medicines by utilizing an approach that combines the analysis of large-scale human genetics data, cutting-edge functional genomics and an array of drug discovery approaches. The Maze COMPASS platform reveals modifier genes that confer protection and provides deeper understanding of the target biology and how these targets can be best targeted with drug therapies. Maze was launched in 2019 by Third Rock Ventures, with funding from ARCH Venture Partners, GV, Foresite Capital, Casdin Capital, Alexandria Venture Investments, City Hill and other undisclosed investors. Maze is based in South San Francisco. For more information, please visit mazetx.com.

    About BridgeBio Pharma, Inc.

    BridgeBio is a team of experienced drug discoverers, developers and innovators working to create life-altering medicines that target well-characterized genetic diseases at their source. BridgeBio was founded in 2015 to identify and advance transformative medicines to treat patients who suffer from Mendelian diseases, which are diseases that arise from defects in a single gene, and cancers with clear genetic drivers. BridgeBio's pipeline of over 20 development programs includes product candidates ranging from early discovery to late-stage development. For more information visit www.bridgebio.com.

    BridgeBio Pharma Forward-Looking Statements

    This press release contains forward-looking statements. Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), which are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements relating to Contour Therapeutics' focus on transforming and advancing breakthrough precision medicine approaches designed to treat cardiovascular disease, the joint venture's focus on advancing genetically validated therapeutic candidates through clinical development and its initial work on the development of a treatment for patients with an undisclosed genetically defined form of heart failure, the partnership's ability to identify and target genetic causes of cardiovascular diseases and build on seminal advances in the treatment of inherited cardiomyopathies, the success of and potential synergies from the joint venture between Maze and BridgeBio, Contour Therapeutics' development plans, competitive environment and clinical and therapeutic potential of therapies for patients with cardiovascular disease, reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, Contour Therapeutics' ability to focus on transforming and advancing breakthrough precision medicine approaches designed to treat cardiovascular disease, the timing and success of advancing genetically validated therapeutic candidates through clinical development and any such continued clinical development and planned regulatory submissions, and the success and potential synergies of the joint venture between Maze and BridgeBio, as well as those risks set forth in the Risk Factors section of BridgeBio Pharma's most recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q and BridgeBio Pharma's other SEC filings. Moreover, BridgeBio Pharma operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

    Media Contacts

    Maze:

    Katie Engleman, 1AB

    katie@1abmedia.com

    BridgeBio Pharma:

    Grace Rauh

    917-232-5478

    grace.rauh@bridgebio.com



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  45. PALO ALTO, Calif., Dec. 04, 2020 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a clinical-stage biopharmaceutical company focused on genetic diseases, today announced that on December 1, 2020, the compensation committee of BridgeBio's board of directors granted 15 new employees options to purchase an aggregate of 15,351 shares of the Company's common stock with a per share exercise price of $51.13 and restricted stock units for an aggregate of 21,092 shares of the Company's common stock. All of the above-described awards were made under BridgeBio's 2019 Inducement Equity Plan (the Plan).

    The above-described awards were each granted as an inducement material to the employees entering into employment with the Company in accordance…

    PALO ALTO, Calif., Dec. 04, 2020 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a clinical-stage biopharmaceutical company focused on genetic diseases, today announced that on December 1, 2020, the compensation committee of BridgeBio's board of directors granted 15 new employees options to purchase an aggregate of 15,351 shares of the Company's common stock with a per share exercise price of $51.13 and restricted stock units for an aggregate of 21,092 shares of the Company's common stock. All of the above-described awards were made under BridgeBio's 2019 Inducement Equity Plan (the Plan).

    The above-described awards were each granted as an inducement material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4), and were granted pursuant to the terms of the Plan. The Plan was adopted by BridgeBio's board of directors in November 2019.

    About BridgeBio

    BridgeBio a team of experienced drug discoverers, developers and innovators working to create life-altering medicines that target well-characterized genetic diseases at their source. BridgeBio was founded in 2015 to identify and advance transformative medicines to treat patients who suffer from Mendelian diseases, which are diseases that arise from defects in a single gene, and cancers with clear genetic drivers. BridgeBio's pipeline of over 20 development programs includes product candidates ranging from early discovery to late-stage development.

    Media Contact:

    Grace Rauh

    Grace.rauh@bridgebio.com

    (917) 232-5478

    Investor Contact:

    John Grimaldi, Burns McClellan

    jgrimaldi@burnsmc.com

    212-213-0006 ext. 362

    Source: BridgeBio Pharma, Inc.



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  46. •  Application accepted under Priority Review designation
    •  Application accepted into Real Time Oncology Review (RTOR) pilot program
    •  This is BridgeBio's second NDA acceptance
    •  Application will also be submitted for review in Australia and Canada under Project Orbis

    PALO ALTO, Calif., Dec. 01, 2020 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a clinical-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, and affiliate QED Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has accepted their New Drug Application (NDA) for infigratinib, an oral FGFR1-3 selective inhibitor, for individuals…

    •  Application accepted under Priority Review designation

    •  Application accepted into Real Time Oncology Review (RTOR) pilot program

    •  This is BridgeBio's second NDA acceptance

    •  Application will also be submitted for review in Australia and Canada under Project Orbis

    PALO ALTO, Calif., Dec. 01, 2020 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a clinical-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, and affiliate QED Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has accepted their New Drug Application (NDA) for infigratinib, an oral FGFR1-3 selective inhibitor, for individuals with cholangiocarcinoma, or cancer of the bile ducts.

    The NDA has been granted Priority Review designation and is being reviewed under the Real-Time Oncology Review (RTOR) pilot program, an initiative of the FDA's Oncology Center of Excellence designed to expedite the delivery of safe and effective cancer treatments to patients. Additionally, BridgeBio will submit for review in Australia and Canada under Project Orbis, an initiative of the FDA's Oncology Center of Excellence that allows for concurrent submission and review of oncology drugs among participating international regulatory agencies.

    Cholangiocarcinoma, a cancer of the bile ducts of the liver, is a serious and often fatal disease which affects approximately 20,000 people in the United States and European Union each year. FGFR2 genetic aberrations are present in approximately 15% to 20% of people who have this disease. Currently, treatment options are limited, and the five-year survival rate is only 9%.

    "We want to thank the patients, families, scientists, physicians and all others involved who helped us move this NDA forward. At BridgeBio we believe that every minute counts for patients and their families, and we are eager to help as many people suffering from cholangiocarcinoma as possible – as quickly as possible," said BridgeBio CEO and Founder Neil Kumar, Ph.D.

    This is BridgeBio's second NDA acceptance following the acceptance of its NDA for fosdenopterin in molybdenum cofactor deficiency (MoCD) Type A in September 2020.

    About Infigratinib

    Infigratinib is an orally administered, ATP-competitive, FGFR1-3 tyrosine kinase inhibitor in development for the treatment of individuals with FGFR-driven conditions, including cholangiocarcinoma (bile duct cancer), urothelial carcinoma (bladder cancer) and achondroplasia, a bone growth condition in children.

    About QED Therapeutics

    QED Therapeutics, an affiliate of BridgeBio Pharma, is a biotechnology company focused on precision medicine for FGFR-driven diseases. Its lead investigational candidate is infigratinib (BGJ398), an orally administered, FGFR1-3 selective tyrosine kinase inhibitor that has shown activity that it believes, based on published data to date, to be meaningful in clinical measures, such as overall response rate, in patients with chemotherapy-refractory cholangiocarcinoma with FGFR2 fusions and advanced urothelial carcinoma with FGFR3 genomic alterations. QED submitted a New Drug Application (NDA) with the United States Food and Drug Administration for second- and later-line cholangiocarcinoma in 2020. QED Therapeutics is also evaluating infigratinib in clinical studies for the treatment of achondroplasia. QED plans to conduct further clinical trials to evaluate the potential for infigratinib to treat patients with other FGFR-driven tumor types and rare disorders. For more information, please visit www.qedtx.com.

    About BridgeBio Pharma, Inc.

    BridgeBio is a team of experienced drug discoverers, developers and innovators working to discover, create, test and deliver life-altering medicines that target well-characterized genetic diseases at their source. BridgeBio was founded in 2015 to identify and advance transformative medicines to treat patients who suffer from Mendelian diseases, which are diseases that arise from defects in a single gene, and cancers with clear genetic drivers. BridgeBio's pipeline of over 20 development programs includes product candidates ranging from early discovery to late-stage development. For more information, visit bridgebio.com.

    BridgeBio Pharma Forward-Looking Statements

    This press release contains forward-looking statements. Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), which are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements relating to QED's clinical development plans, clinical trial results, timing and completion of clinical trials and regulatory submissions, competitive environment and clinical and therapeutic potential of infigratinib, reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, QED's ability to continue its planned clinical development and regulatory submissions for infigratinib and the timing and success of any such continued clinical development and planned regulatory submissions, as well as those risks set forth in the Risk Factors section of BridgeBio Pharma's most recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q and BridgeBio Pharma's other SEC filings. Moreover, BridgeBio Pharma operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

    Contact:

    Grace Rauh

    BridgeBio Pharma, Inc.

    Grace.rauh@bridgebio.com

    (917) 232-5478



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  47. SAN FRANCISCO, Nov. 13, 2020 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) and affiliate Navire Pharma, Inc. announced today that the first patient has been dosed in a Phase 1 clinical trial of its SHP2 inhibitor (BBP-398) in patients with solid tumors driven by mutations in the MAPK signaling pathway, including RAS and receptor tyrosine kinase genes. BBP-398 was developed through a collaboration with The University of Texas MD Anderson Cancer Center's Therapeutics Discovery division.

    In this two-part Phase 1 study, safety and preliminary anti-tumor activity will be examined. Part 1 is a dose escalation to establish the recommended Phase 2 dose (RP2D) of BBP-398. Part 2 will examine preliminary anti-tumor activity in four cohorts…

    SAN FRANCISCO, Nov. 13, 2020 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) and affiliate Navire Pharma, Inc. announced today that the first patient has been dosed in a Phase 1 clinical trial of its SHP2 inhibitor (BBP-398) in patients with solid tumors driven by mutations in the MAPK signaling pathway, including RAS and receptor tyrosine kinase genes. BBP-398 was developed through a collaboration with The University of Texas MD Anderson Cancer Center's Therapeutics Discovery division.

    In this two-part Phase 1 study, safety and preliminary anti-tumor activity will be examined. Part 1 is a dose escalation to establish the recommended Phase 2 dose (RP2D) of BBP-398. Part 2 will examine preliminary anti-tumor activity in four cohorts of patients with certain molecular alterations. Those cohorts include advanced KRAS G12C mutant non-small cell lung carcinoma (NSCLC), advanced KRAS G12C mutant non-NSCLC, advanced solid tumors with other MAPK pathway mutations and advanced EGFR-mutant NSCLC. David S. Hong, professor of Investigational Cancer Therapeutics at MD Anderson, will serve as the lead principal investigator for the study.

    The primary objective of the study is to evaluate the safety of BBP-398 in advanced cancer patients, with secondary objectives assessing preliminary anti-tumor activity, including objective response rates and duration of response. Patients enrolling in the study must have a diagnosis of advanced (primary or recurrent) or metastatic solid tumor with potentially susceptible genomic alterations in the MAPK pathway (excluding BRAF V600X).

    "SHP2 inhibitors have the potential to be effective additions to the therapeutic arsenal for difficult-to-treat cancers by overcoming multiple mechanisms that tumors use to evade treatments," said Eli Wallace, Ph.D., chief scientific officer of oncology at BridgeBio, Navire's parent company. "This study is a critical step in understanding the potential that BBP-398 has for patients with tumors driven by RAS or other MAPK-pathway activating mutations and informing our future clinical development activities."

    SHP2, a conserved protein tyrosine phosphatase, plays a critical role in cell signaling and growth, which are important in the progression of cancer. As SHP2 regulates receptor tyrosine kinase signaling pathways commonly overly activated in cancer, targeting SHP2 may offer a potential new approach to treat this disease.

    BBP-398 was initially discovered and developed by a team of scientists in MD Anderson's Institute for Applied Cancer Science (IACS) and Translational Research to Advance Therapeutics and Innovation in Oncology (TRACTION) platforms, both engines within the Therapeutics Discovery division. The ongoing research is supported by Navire through a global licensing and development agreement with MD Anderson.

    About BridgeBio Pharma

    BridgeBio is a team of experienced drug discoverers, developers and innovators working to create life-altering medicines that target well-characterized genetic diseases at their source. BridgeBio was founded in 2015 to identify and advance transformative medicines to treat patients who suffer from Mendelian diseases, which are diseases that arise from defects in a single gene, and cancers with clear genetic drivers. BridgeBio's pipeline of over 20 development programs includes product candidates ranging from early discovery to late-stage development. For more information visit bridgebio.com.

    About Navire Pharma

    Navire Pharma, an affiliate of BridgeBio, in collaboration with MD Anderson's Therapeutics Discovery division, is developing inhibitors of SHP2 as targeted therapeutics for the treatment of multiple cancers. Together with patients and physicians, the company aims to bring safe, effective treatments to market as quickly as possible. For more information, please visit navirepharma.com



    BridgeBio Pharma Forward-Looking Statements

    This press release contains forward-looking statements. Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Securities Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements relating to Navire Pharma's clinical development plans, clinical trial results, timing and completion of clinical trials, Phase 1 study design and objectives, competitive environment, and clinical and therapeutic potential of BBP-398, an SHP2 inhibitor, reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation, Navire Pharma's ability to continue its planned clinical development for BBP-398 and the timing and success of any such continued clinical development, the therapeutic potential of BBP-398, an SHP2 inhibitor, in patients with solid tumors driven by mutations in the MAPK signaling pathway, including RAS and receptor tyrosine kinase genes, and the continuing success of Navire Pharma's collaboration with The University of Texas MD Anderson Cancer Center's Institute for Applied Cancer Sciences, as well as those set forth in the Risk Factors section of BridgeBio Pharma, Inc.'s most recent Quarterly Report on Form 10-Q and our other SEC filings. Except as required by law, we and Navire Pharma assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

    Contact:

    Grace Rauh

    BridgeBio Pharma

    grace.rauh@bridgebio.com

    917-232-5478

    Source: BridgeBio Pharma, Inc.

     

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  48. -Merger agreement executed between BridgeBio and Eidos Therapeutics; Potential to bring BridgeBio's clinical and commercial development infrastructure to bear upon Eidos' Acoramidis 

    -New Drug Application for Fosdenopterin for the treatment of MoCD Type A accepted by the FDA under Priority Review designation

    -Initiated two new clinical trials since last quarterly update and progressed additional 15 ongoing clinical trials

    -Ended quarter with $710.7 million in cash, cash equivalents and marketable securities

    SAN FRANCISCO, Nov. 05, 2020 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a clinical-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and…

    -Merger agreement executed between BridgeBio and Eidos Therapeutics; Potential to bring BridgeBio's clinical and commercial development infrastructure to bear upon Eidos' Acoramidis 

    -New Drug Application for Fosdenopterin for the treatment of MoCD Type A accepted by the FDA under Priority Review designation

    -Initiated two new clinical trials since last quarterly update and progressed additional 15 ongoing clinical trials



    -Ended quarter with $710.7 million in cash, cash equivalents and marketable securities

    SAN FRANCISCO, Nov. 05, 2020 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a clinical-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, today reported its financial results for the third quarter ended September 30, 2020 and provided an update on the company's operations.

    BridgeBio announced a merger agreement last month with Eidos Therapeutics, Inc. (NASDAQ:EIDX), which is developing acoramidis (formerly AG10), a potential best-in-class transthyretin (TTR) stabilizer for patients with TTR amyloid (ATTR) cardiomyopathy and polyneuropathy. With this transaction, BridgeBio intends to fully and formally welcome Eidos back into its vibrant ecosystem of innovation and has agreed to acquire all of the outstanding common stock of Eidos it does not already own. The company expects to complete the proposed transaction in the first quarter of 2021, subject to certain conditions, including the receipt of stockholder approvals.

    Since the company's last quarterly update, BridgeBio had its first new drug application (NDA) accepted by the U.S. Food and Drug Administration (FDA) under Priority Review designation and initiated two new clinical trials, including a Phase 2 trial of encaleret (calcium sensing receptor antagonist) for autosomal dominant hypocalcemia type 1 (ADH1), one of BridgeBio's four core value driver programs. It also entered into collaboration agreements with the Salk Institute and the University of Colorado Anschutz Medical Campus to advance the development of new therapies for genetically driven diseases.

    BridgeBio held its first-ever R&D Day on September 29, 2020, which focused on the company's drug engineering platform, its targeted oncology portfolio, and four highlighted programs where clinical data are anticipated in the next 12 to 18 months – acoramidis for ATTR, low-dose infigratinib (FGFR inhibitor) for achondroplasia, AAV5 gene therapy for congenital adrenal hyperplasia (CAH), and encaleret for ADH1.

    "We are nearing a significant inflection point as a company as we approach the start of 2021. Our four key programs have critical data readouts within the next year and a half – in ATTR, achondroplasia, CAH and ADH1. We are progressing 17 ongoing clinical trials and we are preparing for commercialization, to bring our first investigational therapy to patients. There has never been a more exciting moment to be at the forefront of the revolution taking place in genetic medicine," said BridgeBio CEO and founder Neil Kumar, Ph.D.

    Recent pipeline progress and corporate updates:

    • BridgeBio and Eidos Therapeutics enter into merger agreement: BridgeBio to acquire all outstanding shares of common stock of Eidos it does not already own; agreement unanimously approved by special committee of Eidos' independent directors. Transaction removes the operational complexity of the current ownership structure and allows BridgeBio to fully invest in opportunities around the investigational drug, acoramidis, including subsequent studies to potentially broaden the evidence for its usage, and accelerate its commercial development using BridgeBio's established infrastructure. Proposed transaction expected to be completed in the first quarter of 2021, subject to certain conditions, including approval by both BridgeBio and Eidos stockholders.



    • Fosdenopterin (formerly BBP-870/ORGN001) – Synthetic cPMP for molybdenum cofactor deficiency (MoCD) Type A: FDA acceptance of NDA under Priority Review designation with Breakthrough Therapy Designation and Rare Pediatric Disease Designation previously granted. There are currently no approved therapies for the treatment of MoCD Type A, which results in severe and irreversible neurological injury for infants and children. This is BridgeBio's first NDA acceptance.



    • New academic partnerships: Established collaboration agreements with the Salk Institute and the University of Colorado Anschutz Medical Campus to advance the discovery of therapies for genetically driven diseases.



    • BridgeBio Pharma R&D Day: Held a virtual R&D Day on September 29, 2020. Presentation replay can be found on BridgeBio's investor website here.

    Major milestones anticipated over the next 12-18 months for BridgeBio's four core value drivers:

    • Acoramidis (AG10) – TTR stabilizer for ATTR: Completed screening in September for pivotal Phase 3 ATTRibute-CM clinical trial of acoramidis in patients with ATTR cardiomyopathy. The study enrolled more than 600 subjects with either wild-type or variant TTR across more than 80 sites in 18 countries. Topline results from Part A of the ATTRibute-CM trial are expected in late 2021 or early 2022 and from Part B in 2023. If Part A is successful, intend to file for regulatory approval of acoramidis in 2022.



    • Low-dose infigratinib – FGFR1-3 inhibitor for achondroplasia: Remain on track to report initial data from the ongoing Phase 2 dose ranging study by end of 2021. Achondroplasia is the most common form of genetic short stature and one of the most commonly known genetic diseases, with 55,000 cases in the United States and European Union. Low-dose infigratinib is the only known therapy in development for achondroplasia that targets the disease at its genetic source and the only orally administered product candidate in clinical stage development.



    • EncaleretCaSR antagonist for ADH1: Initiated Phase 2 clinical study and dosed first patients, with topline proof-of-concept results anticipated in 2021. If the development program is successful, encaleret would be the first approved therapy for ADH1, a condition caused by gain of function variants in the CaSR gene estimated to be carried by 12,000 individuals in the United States.



    • BBP-631 – AAV5 gene therapy candidate for CAH: Investigational New Drug (IND) application-enabling studies for AAV gene therapy proceeding. Remain on track to initiate a first in human Phase 1/2 study and report initial data in 2021. CAH is one of the most prevalent genetic diseases thought to be addressable with AAV gene therapy, with more than 75,000 cases in the United States and European Union.

    Third quarter 2020 financial results:

    Cash, Cash Equivalents and Marketable Securities

    Cash, cash equivalents and marketable securities, excluding restricted cash, totaled $710.7 million as of September 30, 2020, compared to $577.1 million at December 31, 2019. The net increase in cash balance of $133.6 million reflects $537.0 million in net proceeds received from the issuance of our 2.50% Convertible Senior Notes due 2027 (2027 Notes), $24.1 million in net proceeds received from Eidos' at-the-market issuance of shares, offset by payment of $75.0 million to repurchase BridgeBio shares in capped call transactions in connection with the issuance of our 2027 Notes, $49.3 million payment related to capped call option, $13.3 million payments of interest on our debts, and $289.9 million primarily related to operating expenses. 

    Cash, cash equivalents and marketable securities, excluding restricted cash, decreased by $130.2 million compared to our balance as of June 30, 2020, which was $840.9 million. The decrease in cash reflects $9.2 million payments of interests on our debts and $121.0 million primarily related to operating expenses.

    Operating Expenses

    Operating expenses for the three and nine months ended September 30, 2020 were $128.1 million and $355.1 million, respectively, as compared to $81.3 million and $214.3 million, respectively, for the same periods in the prior year. The increases in operating expenses of $46.8 million and $140.8 million during the respective periods were attributable to the increase in external-related costs and increase in headcount to support the progression in our research and development programs, including our increasing research pipelines, and overall growth of our operations.

    Operating expenses for the three months ended September 30, 2020 increased by $3.5 million when compared to the operating expenses for the three months ended June 30, 2020 of $124.6 million.

    Our research and development expenses have not been significantly impacted by the global outbreak of COVID-19 for the periods presented. While we experienced some initial delays in certain of our clinical enrollment and trial commencement activities, we continue to adapt in this unprecedented time to enable alternative site, telehealth and home visits, at home drug delivery, as well as mitigation strategies with our contract manufacturing organizations. The longer-term impact of COVID-19 on our operating expenses is currently unknown.

     
    BRIDGEBIO PHARMA, INC.

    Condensed Consolidated Statements of Operations

    (in thousands, except shares and per share amounts)


     
     Three Months Ended September 30, Nine Months Ended September 30,
      2020   2019   2020   2019 
                    
     

    (Unaudited)
     

    (Unaudited)
    License revenue$ 8,127  $ 26,741  $ 8,127  $ 26,741 
    Operating expenses:       
    Cost of license revenue    2,500      2,500 
    Research and development 92,050   55,278   246,873   152,462 
    General and administrative 36,016   23,495   108,247   59,381 
    Total operating expenses 128,066   81,273   355,120   214,343 
    Loss from operations (119,939)  (54,532)  (346,993)  (187,602)
    Other income (expense), net:       
    Interest income 692   2,736   3,567   6,505 
    Interest expense (10,929)  (2,113)  (25,693)  (5,725)
    Share in net loss of equity

       method investments
        (6,589)     (16,144)
    Other income (expense) 9   (166)  (1,344)  (1,468)
    Total other income

       (expense), net
     (10,228)  (6,132)  (23,470)  (16,832)
    Net loss (130,167)  (60,664)  (370,463)  (204,434)
    Net loss attributable to

      redeemable convertible

      noncontrolling interests and

      noncontrolling interests
     14,308   684   41,720   17,305 
    Net loss attributable to common

      Stockholders of BridgeBio
    $ (115,859) $ (59,980) $ (328,743) $ (187,129)
    Net loss per share, basic and diluted$ (0.98) $ (0.51) $ (2.79) $ (1.86)
    Weighted-average shares used in

       computing net loss per share,

       basic and diluted
     118,168,063   117,071,188   117,663,038   100,855,481 
     



     
    BRIDGEBIO PHARMA, INC.

    Condensed Consolidated Balance Sheets

    (In thousands)


     
     September 30, December 31,
      2020  2019 
    Assets(Unaudited)  (1) 
    Cash and cash equivalents and marketable securities (2)$ 710,681 $ 577,137 
    Receivable from a related party 8,000  2,845 
    Prepaid expenses and other current assets 26,703  19,784 
    Property and equipment, net 16,182  5,625 
    Operating lease right-of-use assets 9,644   
    Other assets 16,483  26,288 
    Total assets$ 787,693 $ 631,679 
    Liabilities, Redeemable Convertible Noncontrolling

     Interests and Stockholders' Equity
       
    Accounts payable$ 9,839 $ 8,852 
    Accrued liabilities 57,053  39,455 
    LEO call option liability 5,198  4,078 
    Operating lease liabilities 11,853   
    Build-to-suit lease obligation   8,000 
    Term loans, net 93,392  91,791 
    2027 Notes, net 378,502   
    Other liabilities 13,469  3,527 
    Redeemable convertible noncontrolling interests 2,574  2,243 
    Total BridgeBio stockholders' equity 163,756  408,454 
    Noncontrolling interests 52,057  65,279 
    Total liabilities, redeemable convertible noncontrolling

            interests and stockholders' equity
    $ 787,693 $ 631,679 



    (1)The condensed consolidated balance sheet as of December 31, 2019 is derived from the audited consolidated financial statements as of that date. Certain reclassifications have been made to conform to the September 30, 2020 condensed consolidated balance sheet presentation.
    (2)December 31, 2019 amounts include long-term marketable securities of $31.1 million.

     
       

    About BridgeBio Pharma, Inc.

    BridgeBio is a team of experienced drug discoverers, developers and innovators working to discover, create, test and deliver life-altering medicines that target well-characterized genetic diseases at their source. BridgeBio was founded in 2015 to identify and advance transformative medicines to treat patients who suffer from Mendelian diseases, which are diseases that arise from defects in a single gene, and cancers with clear genetic drivers. BridgeBio's pipeline of over 20 development programs includes product candidates ranging from early discovery to late-stage development. For more information, visit bridgebio.com.

    BridgeBio Pharma Forward-Looking Statements

    This press release contains forward-looking statements. Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), which are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements relating to expectations, plans and prospects regarding the preclinical and clinical development plans, clinical trial designs, clinical and therapeutic potential, and strategy of BridgeBio's product candidates, our ability to complete, and any effects of, the proposed merger transaction with Eidos, the unknown future impact of the COVID-19 pandemic delay on certain clinical trial milestones and/or BridgeBio's operations or operating expenses, the number of potential medicines in our portfolio, our ability to enroll our trials, the timing and success of our clinical trials, including our Phase 2 trial of encaleret for ADH1, the success of our collaboration agreements with each of the Salk Institute and the University of Colorado Anschutz Medical Campus and our other collaboration agreements with various academic institutions, the timing and success of our data readouts in each of acoramidis for the treatment of ATTR, low-dose infigratinib for the treatment of achondroplasia, BBP-631 for the treatment of CAH and encalaret for the treatment of ADH1, the regulatory strategy of fosdenopterin for the treatment of MoCD Type A, our ability to produce meaningful medicines, our expected runway for cash, cash equivalents and marketable securities, and the timing of these events, including the timing of the completion of our proposed merger with Eidos, reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by  a number of risks, uncertainties and assumptions, including, but not limited to, the success of clinical trials, regulatory filings, approvals and/or sales, potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy, the occurrence of any event, change or other circumstance that could give rise to the termination of the proposed transaction with Eidos, the risk that Eidos' and/or BridgeBio's stockholders may not approve the proposed transaction, the inability to complete the proposed transaction because, among other reasons, conditions to the closing of the proposed transaction may not be satisfied or waived, uncertainty as to the timing of completion of the proposed transaction, potential adverse effects or changes to relationships with employees, suppliers, strategic partners or other parties resulting from the announcement or completion of the proposed transaction, potential litigation relating to the proposed transaction that could be instituted against Eidos, BridgeBio or their respective directors and officers, including the effects of any outcomes related thereto, possible disruptions from the proposed transaction that could harm Eidos' or BridgeBio's respective business, including current plans and operations, unexpected costs, charges or expenses resulting from the proposed transaction, uncertainty of the expected financial performance of each of Eidos and BridgeBio following completion of the proposed transaction, including the possibility that the expected synergies and value creation from the proposed transaction will not be realized or will not be realized within the expected time period, and those risks set forth in the Risk Factors section of our most recent quarterly or annual periodic report filed with the U.S. Securities and Exchange Commission (SEC) and our other SEC filings. Moreover, BridgeBio operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of BridgeBio's management as of the date of this release and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

    Contact:

    Grace Rauh

    BridgeBio Pharma

    grace.rauh@bridgebio.com        

    917-232-5478

    Source: BridgeBio Pharma, Inc.

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  49. PALO ALTO, Calif., Nov. 04, 2020 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a clinical-stage biopharmaceutical company focused on genetic diseases, today announced that on November 1, 2020, the compensation committee of BridgeBio's board of directors granted three new employees restricted stock units for an aggregate of 9,566 shares of the Company's common stock. All of the above-described awards were made under BridgeBio's 2019 Inducement Equity Plan (the Plan).

    The above-described awards were each granted as an inducement material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4), and were granted pursuant to the terms of the Plan. The Plan was adopted by BridgeBio's…

    PALO ALTO, Calif., Nov. 04, 2020 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a clinical-stage biopharmaceutical company focused on genetic diseases, today announced that on November 1, 2020, the compensation committee of BridgeBio's board of directors granted three new employees restricted stock units for an aggregate of 9,566 shares of the Company's common stock. All of the above-described awards were made under BridgeBio's 2019 Inducement Equity Plan (the Plan).

    The above-described awards were each granted as an inducement material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4), and were granted pursuant to the terms of the Plan. The Plan was adopted by BridgeBio's board of directors in November 2019.

    About BridgeBio

    BridgeBio is a team of experienced drug discoverers, developers and innovators working to create life-altering medicines that target well-characterized genetic diseases at their source. BridgeBio was founded in 2015 to identify and advance transformative medicines to treat patients who suffer from Mendelian diseases, which are diseases that arise from defects in a single gene, and cancers with clear genetic drivers. BridgeBio's pipeline of over 20 development programs includes product candidates ranging from early discovery to late-stage development.

    Media Contact:

    Grace Rauh

    Grace.rauh@bridgebio.com

    (917) 232-5478

    Investor Contact:

    John Grimaldi, Burns McClellan

    jgrimaldi@burnsmc.com

    212-213-0006 ext. 362

    Source: BridgeBio Pharma, Inc. 

    Primary Logo

    View Full Article Hide Full Article
  50. PALO ALTO, Calif. and DENVER, Oct. 21, 2020 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) and the University of Colorado Anschutz Medical Campus today announced a collaboration to advance novel research on genetically driven diseases into therapeutic applications for patients.

    "We are grateful to be collaborating with the University of Colorado Anschutz Medical Campus, which is the largest academic health center in the Rocky Mountain region, a world-class medical destination, and home to one of the leading Personalized Medicine Centers in the country. We are excited to work together to translate life-changing discoveries from the lab into potential medicines for patients," said BridgeBio CEO and founder Neil Kumar, Ph.D.

    PALO ALTO, Calif. and DENVER, Oct. 21, 2020 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) and the University of Colorado Anschutz Medical Campus today announced a collaboration to advance novel research on genetically driven diseases into therapeutic applications for patients.

    "We are grateful to be collaborating with the University of Colorado Anschutz Medical Campus, which is the largest academic health center in the Rocky Mountain region, a world-class medical destination, and home to one of the leading Personalized Medicine Centers in the country. We are excited to work together to translate life-changing discoveries from the lab into potential medicines for patients," said BridgeBio CEO and founder Neil Kumar, Ph.D.

    This collaboration comes on the heels of an eight-month pilot collaboration. Under the new, expanded collaboration, BridgeBio will support early-discovery research already underway in CU Anschutz labs and will accelerate promising therapies into the clinic in order to develop and ultimately commercialize therapies for patients. The collaboration's structure focuses on close partnership, actionable feedback and joint touchpoints between the BridgeBio and the CU Anschutz research teams.

    "This collaboration represents a new model between academia and the pharmaceutical industry. It provides all CU Anschutz faculty with the opportunity to translate cutting edge research in genetic science to patients with unmet needs," said Kimberly Muller, Executive Director of CU Innovations. "BridgeBio is uniquely suited as a collaborator as they combine a novel drug discovery platform, with the processes needed to advance multiple individual therapies simultaneously. Together, we will find, develop and deliver breakthrough medicines for genetic diseases to patients as quickly and safely as possible."

    BridgeBio is determined to move away from traditional one-off interactions between drug development companies and research institutions and formalize collaborations that are built on trust, engagement, science and respect. The BridgeBio team is committed to acting responsibly with academic researchers who work around the clock to understand the mechanisms of genetically driven conditions and how we can best treat patients by targeting the disease source.

    About BridgeBio Pharma

    BridgeBio is a team of experienced drug discoverers, developers and innovators working to create life-altering medicines that target well-characterized genetic diseases at their source. BridgeBio was founded in 2015 to identify and advance transformative medicines to treat patients who suffer from Mendelian diseases, which are diseases that arise from defects in a single gene, and cancers with clear genetic drivers. BridgeBio's pipeline of over 20 development programs includes product candidates ranging from early discovery to late-stage development. For more information, please visit bridgebio.com.

    About the University of Colorado Anschutz Medical Campus

    The University of Colorado Anschutz Medical Campus is a world-class medical destination at the forefront of transformative science, medicine, education, and healthcare. The campus encompasses the University of Colorado health professional schools, more than 60 centers and institutes, and two nationally ranked hospitals that treat more than 2 million adult and pediatric patients each year. Innovative, interconnected and highly collaborative, together we deliver life-changing treatments, patient care, professional training, and conduct world-renowned research powered by more than $500 million in research awards. For more information, visit https://www.cuanschutz.edu

    About CU Innovations

    CU Innovations, located on the University of Colorado Anschutz Medical Campus, is a leading biomedical hub for industry partners, entrepreneurs, and investors to partner with CU researchers creating breakthrough technologies. With expertise in patents, copyrights, and licensing, CU Innovations helps to translate discovery into impact through transparent, flexible, best practice intellectual property management services. CU Innovations connects CU Anschutz researchers with a variety of commercialization programs in the University and the community. To learn more about CU Innovations visit cuanschutz.edu/cu-innovations.

    BridgeBio Pharma Forward-Looking Statements

    This press release contains forward-looking statements. Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), which are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements relating to expectations, plans, and prospects regarding our ability to build on the significant advances being made in CU Anschutz's labs and translate them into meaningful medicines for patients in need, the success of current and future relationships with third-party collaborators and academic partners, and the potential ability of our product candidates to treat genetically driven diseases and cancers with clear genetic drivers, reflect our current views about our plans, intentions, expectations, strategies and prospects, and are based on the information currently available to us and on assumptions we have made and are neither forecasts, promises nor guarantees. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by these forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, the success of our product candidates to treat genetically driven diseases and cancers with clear genetic drivers, the success of our collaboration with CU Anschutz, as well as those risks set forth in the Risk Factors section of BridgeBio Pharma's most recent Quarterly Report on Form 10-Q and BridgeBio Pharma's other SEC filings. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

    BridgeBio Contact:

    Grace Rauh

    BridgeBio Pharma, Inc.

    Grace.rauh@bridgebio.com

    (917) 232-5478

    University of Colorado School of Medicine Contact:

    Rolfe Bautista

    Marketing Analyst | CU Innovations

    University of Colorado Anschutz Medical Campus

    Rolfe.bautista@cuanschutz.edu

    (303) 724-1068

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  51. LA JOLLA and PALO ALTO, Calif., Oct. 21, 2020 (GLOBE NEWSWIRE) -- The Salk Institute and BridgeBio Pharma, Inc. (NASDAQ:BBIO) today announced a three-year collaboration agreement formed to advance cutting-edge academic discoveries in genetically driven diseases toward therapeutic applications. Under the partnership, BridgeBio will help fund research programs from Salk's world-renowned innovative cancer research, with the eventual goal of developing new therapeutics for patients in need.

    "Salk is known for its outstanding research, in particular in the field of oncology, so we are excited to enter into this partnership with BridgeBio to advance our discoveries and help develop next-generation therapies," says Salk Vice President and Chief…

    LA JOLLA and PALO ALTO, Calif., Oct. 21, 2020 (GLOBE NEWSWIRE) -- The Salk Institute and BridgeBio Pharma, Inc. (NASDAQ:BBIO) today announced a three-year collaboration agreement formed to advance cutting-edge academic discoveries in genetically driven diseases toward therapeutic applications. Under the partnership, BridgeBio will help fund research programs from Salk's world-renowned innovative cancer research, with the eventual goal of developing new therapeutics for patients in need.

    "Salk is known for its outstanding research, in particular in the field of oncology, so we are excited to enter into this partnership with BridgeBio to advance our discoveries and help develop next-generation therapies," says Salk Vice President and Chief Science Officer Martin Hetzer, Ph.D. "The partnership represents an excellent opportunity for academic research to reach new potential in the clinical setting."

    "BridgeBio is focused on partnering with leading academic institutions to accelerate promising research into clinical studies, with a range of therapeutic modalities such as biologics, gene therapies and small molecules," said BridgeBio CEO and founder Neil Kumar, Ph.D. "The Salk Institute is known as a place where great science is occurring—and has occurred for decades—and we feel privileged to have the opportunity to partner with them. Through this partnership, we look forward to translating exciting academic findings into potential treatments and understanding the impact they may bring to patients."

    The Salk Cancer Center is one of seven National Cancer Institute (NCI)-designated basic research cancer centers in the United States. Here, researchers are using game-changing technologies to expose the molecular mechanisms underlying tumors in order to develop targeted cancer therapies. Salk is also home to the Conquering Cancer Initiative, which is a scientific and philanthropic endeavor to bring together collaborative cancer researchers to harness new strategies against five deadly cancers: pancreatic, ovarian, lung, brain (glioblastoma) and triple-negative breast. Salk's scientists aim to identify cancer's vulnerabilities in order to develop new methods that can attack the tumors while leaving the healthy tissues alo