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1. 12 August 2020 BridgeBio Pharma Reports Inducement Grants under Nasdaq Listing Rule 5635(c)(4)

   PALO ALTO, Calif., Aug. 12, 2020 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a clinical-stage biopharmaceutical company focused on genetic diseases, today announced that on August 3, 2020, the compensation committee of BridgeBio's board of directors granted twenty-two employees options to purchase an aggregate of 30,443 shares of the Company's common stock with a per share exercise price of $27.20 and restricted stock units for an aggregate of 61,760 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., Aug. 12, 2020 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a clinical-stage biopharmaceutical company focused on genetic diseases, today announced that on August 3, 2020, the compensation committee of BridgeBio's board of directors granted twenty-two employees options to purchase an aggregate of 30,443 shares of the Company's common stock with a per share exercise price of $27.20 and restricted stock units for an aggregate of 61,760 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
   
   
   
   (917) 232-5478

   Investor Contact:
   
   John Grimaldi, Burns McClellan
   
   
   
   212-213-0006 ext. 362

   Source: BridgeBio Pharma, Inc.

   

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2. 11 August 2020 BridgeBio Pharma, Inc. Reports Second Quarter 2020 Financial Results and Business Update

   -Initiated four clinical trials, progressed its additional 11 ongoing clinical trials and submitted three INDs to FDA since the beginning of 2020
   

   -Strategic collaboration with Perceptive Advisors-founded company LianBio expands BridgeBio's global reach into China

   -Ended quarter with $840.9 million in cash, cash equivalents and marketable securities

   SAN FRANCISCO, Aug. 11, 2020 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a clinical-stage biopharmaceutical company focused on genetic diseases and cancers with clear genetic drivers, today reported its financial results for the second quarter ending June 30, 2020 and provided an update on the company's operations.

   Since the beginning of 2020, BridgeBio has initiated four company-sponsored…

   -Initiated four clinical trials, progressed its additional 11 ongoing clinical trials and submitted three INDs to FDA since the beginning of 2020
   
   

   -Strategic collaboration with Perceptive Advisors-founded company LianBio expands BridgeBio's global reach into China

   -Ended quarter with $840.9 million in cash, cash equivalents and marketable securities

   SAN FRANCISCO, Aug. 11, 2020 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a clinical-stage biopharmaceutical company focused on genetic diseases and cancers with clear genetic drivers, today reported its financial results for the second quarter ending June 30, 2020 and provided an update on the company's operations.

   Since the beginning of 2020, BridgeBio has initiated four company-sponsored clinical trials, progressed its additional 11 ongoing clinical trials, submitted three Investigational New Drug (IND) applications to the U.S. Food and Drug Administration (FDA), and completed the rolling submission of its first New Drug Application (NDA) with the FDA. During the quarter, BridgeBio strengthened its corporate governance by adding three world-class independent directors to its board. In addition, it recently entered into a partnership with Perceptive Advisors-founded company LianBio, expanding BridgeBio's global reach into China.

   BridgeBio remains on track with each of its four core value drivers - acoramidis (formerly AG10, TTR stabilizer) for ATTR cardiomyopathy, low-dose infigratinib (FGFRi) for achondroplasia, AAV5 gene therapy for congenital adrenal hyperplasia (CAH), and encaleret (CaSRi) for autosomal dominant hypocalcemia type 1 (ADH1) - and the company believes it is adequately financed through key readouts for each of these programs. Notably, BridgeBio dosed the first child in its Phase 2 clinical trial of infigratinib in achondroplasia in July.

   The strategic collaboration with LianBio will initially focus on targeted oncology. BridgeBio's near-term economics includes a total of $26.5 million in upfront and milestone payments. BridgeBio will additionally receive up to $505 million in future milestone payments, tiered royalty payments ranging from single- to double-digits and increase its equity interest via investment in LianBio. BridgeBio CEO Neil Kumar has also been appointed to the LianBio board of directors.

   Across the company, BridgeBio's drug engineering platform continues to deliver. Strengthening its ability to discover new targets, it established collaboration agreements with Johns Hopkins University and University of Florida and continues to assess a wide variety of new programs in the genetic disease space. BridgeBio's pre-clinical platform has expanded to include additional modalities such as antisense oligonucleotides and deepened expertise in critical areas such as molecular modeling and novel statistical approaches to genetics. Its clinical platform has grown and now encompasses more than 350 trial sites in over 25 countries.

   "On a risk-adjusted basis we are in a great position to produce meaningful medicines for patients and meaningful returns to investors over the next 18 to 24 months. This is exemplified by our disease-modifying, first or best-in-class therapeutic candidates for ATTR, achondroplasia, ADH1, and CAH. We intend to deliver on this goal by expanding our industry-leading target identification and research engine and global clinical development infrastructure, and look forward to delivering our medicines, once approved, to patients through our growing commercial organization," said BridgeBio CEO and founder Neil Kumar, Ph.D.

   Recent pipeline progress and corporate updates:

   • Low-dose infigratinib – Selective FGFR inhibitor for achondroplasia: Dosed first child in the Phase 2 clinical program (PROPEL 2) (NCT04265651).

   • BBP-418 – Glycosylation substrate pro-drug for LGMD2i: Dosed first subject in Phase 1 clinical trial in healthy volunteers.

   • Expansion into China through partnership with LianBio: BridgeBio entered into a strategic collaboration with Perceptive Advisors-founded LianBio, expanding its reach into China and other major Asian markets. The initial focus of the collaboration will be targeted oncology. Under the terms of the agreements, LianBio receives commercial rights in China and selected Asian markets and will participate in clinical development activities for BridgeBio's Phase 3 FGFR inhibitor infigratinib and Phase 1-ready SHP2 inhibitor BBP-398. BridgeBio's near-term economics includes a total of $26.5 million in upfront and milestone payments. BridgeBio will additionally receive up to $505 million in future milestone payments, tiered royalty payments ranging from single- to double-digits and increase its equity interest via investment in LianBio. BridgeBio CEO Neil Kumar has also been appointed to the LianBio board of directors.

   • Three new independent directors added to BridgeBio's board:
     
         ○  Brent Saunders, former Allergan CEO and biopharma deal-maker
     
         ○  Randy Scott, Ph.D., genomics pioneer and entrepreneur
     
         ○  Andrew Lo, Ph.D., renowned economist and BridgeBio co-founder

   • New academic partnerships: Established collaboration agreements with Johns Hopkins University and University of Florida to accelerate the development of new medicines in genetically driven diseases.

   • BridgeBio Pharma R&D Day: BridgeBio will hold a virtual R&D Day on Tuesday, Sept. 29, 2020 from 8:30 am ET – noon. The event will be webcast, with a link available on the event calendar at https://investor.bridgebio.com/.

   Major milestones anticipated over the next 18-24 months for BridgeBio's four core value drivers:

   • Acoramidis (formerly AG10) – TTR stabilizer for ATTR: Remain on track to complete enrollment in the Phase 3 ATTRibute-CM study in ATTR cardiomyopathy (ATTR-CM) in the first half of 2021, with topline data expected in the first half of 2022. Acoramidis is a potentially best in class TTR stabilizer for ATTR-CM, a large and growing disease affecting >400K patients globally, and one of the first drug candidates to arise from BridgeBio's drug engineering platform.

   • Low-dose infigratinib – FGFR1-3 inhibitor for achondroplasia: Remain on track to report initial data from the ongoing Phase 2 dose ranging study by YE2021. Achondroplasia is the most common form of genetic short stature and one of the most commonly-known genetic diseases, with >55K cases in the US and EU. 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.

   • Encaleret – CaSR antagonist for Autosomal Dominant Hypocalcemia Type 1 (ADH1): Remain on track to initiate the planned Phase 2 study in 2020, with potential proof-of-concept data available 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 calcium-sensing receptor gene estimated to be carried by 12k individuals in the US.

   • BBP-631 – AAV5 gene therapy candidate for congenital adrenal hyperplasia (CAH): IND-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 >75K cases in the US and EU.

   Second quarter 2020 financial results:

   Cash, Cash Equivalents and Marketable Securities

   Cash, cash equivalents and marketable securities, excluding restricted cash, totaled $840.9 million as of June 30, 2020 compared to $577.1 million at December 31, 2019. The net change in cash balance of $263.8 million reflects $537.0 million in net proceeds received from the issuance of our 2.50% Convertible Senior Notes due 2027, $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, $49.3 million payment related to capped call option and the remaining payment of $173.0 million primarily related to operating expenses. 

   Operating Expenses

   Operating expenses for the second quarter and first half of 2020 were $124.6 million and $227.1 million, as compared to $69.3 million and $133.1 million, respectively, for the same periods in the prior year. The increases in operating expenses of $55.2 million and $94.0 million during the 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.

   Our research and development expenses have not been significantly impacted by the global outbreak of COVID-19 for the periods presented. While we have 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 June 30,								Six Months Ended June 30,
   			2020				2019				2020				2019
   		(Unaudited)								(Unaudited)
   Operating expenses:
   Research and development		$ 86,598				$ 52,331				$ 154,823				$ 97,184
   General and administrative			37,969				16,987				72,231				35,886
   Total operating expenses			124,567				69,318				227,054				133,070
   Loss from operations			(124,567)				(69,318)				(227,054)				(133,070)
   Other income (expense), net:
   Interest income			934				1,662				2,875				3,769
   Interest expense			(10,754)				(1,941)				(14,764)				(3,612)
   Share in net loss of equity method investments			—				(4,956)				—				(9,555)
   Other income (expense)			(1,827)				219				(1,353)				(1,302)
   Total other income (expense), net			(11,647)				(5,016)				(13,242)				(10,700)
   Net loss			(136,214)				(74,334)				(240,296)				(143,770)
   Net loss attributable to redeemable convertible noncontrolling interests and noncontrolling interests			15,180				8,370				27,412				16,621
   Net loss attributable to common stockholders of BridgeBio		$ (121,034)				$ (65,964)				$ (212,884)				$ (127,149)
   Net loss per share, basic and diluted		$ (1.03)				$ (0.71)				$ (1.81)				$ (1.37)
   Weighted-average shares used in computing net loss per share, basic and diluted			117,012,062				92,893,303				117,407,750				92,613,243

   
   
   

   BRIDGEBIO PHARMA, INC.
   
   Condensed Consolidated Balance Sheets
   
   (In thousands)

   				June 30, 2020				December 31, 2019
   Assets				(Unaudited)					(1)
   Cash and cash equivalents and marketable securities (2)				$ 840,939				$ 577,137
   Prepaid expenses and other current assets					20,996				22,629
   Property and equipment, net					15,573				5,625
   Operating lease right-of-use assets					10,465				—
   Other assets					17,254				26,288
   Total assets				$ 905,227				$ 631,679
   Liabilities, Redeemable Convertible Noncontrolling Interests and Stockholders' Equity
   Accounts payable				$ 12,835				$ 8,852
   Accrued liabilities					70,902				39,455
   LEO call option liability					5,276				4,078
   Operating lease liabilities					12,744				—
   Build-to-suit lease obligation					—				8,000
   Term loans					92,908				91,791
   2027 Notes					373,651				—
   Other liabilities					9,399				3,527
   Redeemable convertible noncontrolling interests					1,906				2,243
   Total BridgeBio stockholders' equity					265,759				408,454
   Noncontrolling interests					59,847				65,279
   Total liabilities, redeemable convertible noncontrolling interests and stockholders' equity				$ 905,227				$ 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.
   (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 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 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, including, but not limited to, 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, including completing enrollment in the Phase 3 ATTRibute-CM study of acoramidis (formerly AG10, TTR stabilizer) for ATTR cardiomyopathy and the availability of topline data, our ability to continue enrolling the ongoing PROPEL 2 trial of low-dose infigratinib (FGFRi) for achondroplasia, the success of our Phase 1 clinical trial in healthy volunteers for BBP-418 Glycosylation substrate pro-drug for LGMD2i, our plans to commence the Phase 1/2 study of AAV5 gene therapy for congenital adrenal hyperplasia (CAH), our plans to commence the Phase 2 study in 2020 in encaleret (CaSRi) for autosomal dominant hypocalcemia type 1 (ADH1), the success of our strategic partnership with LianBio and our other collaboration agreements with various academic institutions, our ability to produce meaningful medicines, our expected runway for cash, cash equivalents and marketable securities, and the timing of these events, including the anticipated receipt of future milestone and/or royalty payments from LianBio, 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, including those of infigratinib and BBP-398 in China and other major Asian markets, 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.
   
   
   
   (917) 232-5478

   Source: BridgeBio Pharma, Inc.

    
   
   

   

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3. 11 August 2020 BridgeBio Pharma Expands Reach Into China and Other Major Asian Markets Through Strategic Collaboration With Perceptive Advisors-Founded Company, LianBio

   $26.5 million total near-term payments to BridgeBio, plus participation in long-term value creation of up to $505 million in milestone payments, tiered double-digit royalty payments and an equity interest in LianBio.
   

   BridgeBio CEO and founder Neil Kumar, Ph.D., has been appointed to LianBio's board of directors.

   PALO ALTO, Calif., Aug. 11, 2020 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a clinical-stage biopharmaceutical company focused on genetic diseases and cancers with clear genetic drivers, today announced that it is partnering with Shanghai-based LianBio, a new company founded by Perceptive Advisors, to expand its global reach into China, the second-largest pharmaceutical market in the world. The partnership marks the…

   $26.5 million total near-term payments to BridgeBio, plus participation in long-term value creation of up to $505 million in milestone payments, tiered double-digit royalty payments and an equity interest in LianBio.
   
   

   BridgeBio CEO and founder Neil Kumar, Ph.D., has been appointed to LianBio's board of directors.

   PALO ALTO, Calif., Aug. 11, 2020 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), a clinical-stage biopharmaceutical company focused on genetic diseases and cancers with clear genetic drivers, today announced that it is partnering with Shanghai-based LianBio, a new company founded by Perceptive Advisors, to expand its global reach into China, the second-largest pharmaceutical market in the world. The partnership marks the first major expansion of BridgeBio's pipeline into Asian markets.

   This strategic relationship will initially focus on two of BridgeBio's targeted oncology drug candidates, FGFR inhibitor infigratinib, currently in Phase 3 development for FGFR-driven tumors and Phase 1-ready SHP2 inhibitor BBP-398, for tumors driven by RAS and receptor tyrosine kinase mutations. The agreement also provides LianBio with preferential future access in the territory 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 to quickly bring innovation to large numbers of patients with high unmet need.

   "Tremendous patient need and a fast-developing healthcare infrastructure make China a strategic priority. We are eager to not only expand late-stage therapies to the broader patient population there, but also to accelerate our clinical development efforts in Asia and better understand and address the needs of patients there – early. We are grateful to be deepening our relationship with Perceptive Advisors through this agreement with LianBio and look forward to a lasting partnership focused on expanding our reach to patients," said BridgeBio CEO and founder Neil Kumar, Ph.D.

   "We value our relationship with BridgeBio and are happy to be enabling the entry of important programs to LianBio's territories," said Adam Stone, CIO of Perceptive Advisors. "BridgeBio and its affiliate companies exemplify the commitment to science-driven, precision medicine that we believe is a key driver to innovation in healthcare. We are excited about this opportunity to leverage their promising pipeline and LianBio's local expertise to accelerate both global development and local access to leading edge therapeutics."

   Under the terms of the agreements, LianBio will receive commercial rights in China and selected Asian markets and participate in clinical development activities for infigratinib (housed in BridgeBio affiliate QED) and BBP-398 (housed in BridgeBio affiliate Navire). BridgeBio's near-term economics includes a total of $26.5 million in upfront and milestone payments. BridgeBio will receive up to $505 million in future milestone payments, tiered royalty payments from single- to double-digits on net sales of both products in licensed territories. Additionally, BridgeBio will increase its equity interest via investment in LianBio and BridgeBio CEO Neil Kumar has been appointed to the LianBio board of directors.

   LianBio is participating in the ongoing Phase 3 study of infigratinib in first line cholangiocarcinoma (PROOF) in mainland China and further plans to initiate a Phase 2a study of infigratinib in gastric cancer and other FGFR-driven tumors. Additionally, LianBio will contribute to clinical development of BBP-398 in combination with various agents in solid tumors such as non-small cell lung cancer (NSCLC), colorectal and pancreatic cancer, in mainland China and other major Asian markets.

   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 www.bridgebio.com.

   About LianBio

   LianBio's mission is to catalyze the development and accelerate availability of paradigm-shifting medicines to patients in China and major Asian markets through partnerships that provide access to the best science-driven therapeutic discoveries. LianBio collaborates with world-class partners across a diverse array of therapeutic and geographic areas to build out a pipeline based on disease relevance and the ability to impact patients with transformative mechanisms and precision-based therapeutics. For more information, please visit www.lianbio.com.

   About Perceptive Advisors

   Founded in 1999, Perceptive Advisors is a leading life sciences focused investment firm with over $7 billion of regulatory assets under management as of June 30, 2020. Since inception, Perceptive Advisors has focused on supporting progress in the life sciences industry by identifying opportunities and directing financial resources toward the most promising technologies in modern healthcare. For more information, please visit www.perceptivelife.com.

   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 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 intends to submit 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 Navire Pharma

   Navire Pharma, an affiliate of BridgeBio Pharma, and in collaboration with the Institute for Applied Cancer Science at MD Anderson, 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 www.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 (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 BridgeBio's anticipated receipt of future milestone and/or royalty payments from LianBio, 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 of infigratinib and BBP-398 in China and other major Asian markets, 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.
   
   
   
   (917) 232-5478

   Source: BridgeBio Pharma, Inc.

   

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4. 28 July 2020 Ivy Brain Tumor Center and BridgeBio Pharma's QED Therapeutics Announce Dosing of First Patient in Investigator-Initiated Phase 0/2 Clinical Trial of Infigratinib in Recurrent Glioblastoma

   • Precision medicine study designed to confirm drug's ability to cross blood-brain barrier and hit molecular targets in high-grade glioma patients with FGFR genetic alterations
   • Patients with a positive PK response will continue on infigratinib after surgery

   PHOENIX and SAN FRANCISCO, July 28, 2020 (GLOBE NEWSWIRE) -- Ivy Brain Tumor Center at Barrow Neurological Institute announced today that the first patient has been dosed in an investigator-initiated Phase 0/2 clinical trial of infigratinib in recurrent high-grade glioma driven by FGFR genetic alterations. Infigratinib is an investigational, orally administered, FGFR1-3 selective tyrosine kinase inhibitor being developed by BridgeBio Pharma, Inc. (NASDAQ:BBIO) affiliate company QED Therapeutics, …

   • Precision medicine study designed to confirm drug's ability to cross blood-brain barrier and hit molecular targets in high-grade glioma patients with FGFR genetic alterations
   • Patients with a positive PK response will continue on infigratinib after surgery

   PHOENIX and SAN FRANCISCO, July 28, 2020 (GLOBE NEWSWIRE) -- Ivy Brain Tumor Center at Barrow Neurological Institute announced today that the first patient has been dosed in an investigator-initiated Phase 0/2 clinical trial of infigratinib in recurrent high-grade glioma driven by FGFR genetic alterations. Infigratinib is an investigational, orally administered, FGFR1-3 selective tyrosine kinase inhibitor being developed by BridgeBio Pharma, Inc. (NASDAQ:BBIO) affiliate company QED Therapeutics, Inc.

   The investigator-initiated Phase 0/2 trial is designed to confirm drug effects within days of exposure, and only to continue dosing when the drug is active in a patient's own tumor. The primary objective of the Phase 0 arm is to assess how effectively infigratinib can cross the blood-brain barrier – the most significant obstacle to developing new, effective therapies for aggressive brain tumors like glioblastoma. Patients with successful tumor penetration will receive infigratinib long-term in a Phase 2 expansion arm of the trial. The primary endpoint of the expansion phase is progression-free survival rate at six months. The study will also measure how well infigratinib is impacting its molecular target in each patient's tumor.

   FGFR (fibroblast growth factor receptor) genetic alterations have been shown to spur growth in malignant tumors. Five to seven percent of glioblastoma patients' tumors are driven by FGFR signaling. During the trial screening process, the patient's tumor tissue from prior surgery will be tested for the FGFR-TACC3 fusion gene or mutations in FGFR1 and FGFR3 genes. Patients with tumors that have these fusions or mutations are eligible for this study.

   "In the preclinical studies, our pharmacokinetics program at the Ivy Brain Tumor Center tested seven FGFR inhibitors for their ability to cross the blood-brain barrier. Infigratinib was one of the most promising agents," said Shwetal Mehta, Ph.D., deputy director of the Ivy Brain Tumor Center.

   "Infigratinib was previously tested in an uncontrolled Phase 2 study for recurrent high-grade gliomas," said Nader Sanai, M.D., director of the Ivy Brain Tumor Center. "The results were intriguing, but inconclusive. This Ivy Phase 0/2 trial seeks to provide direct biological evidence of drug effects in individual patients, allowing us to understand which glioblastoma patients may benefit from infigratinib."

   "The launch of this investigator-initiated trial is an exciting step in the study of infigratinib for patients with recurrent, high-grade glioma," said Susan Moran, M.D., M.S.C.E., chief medical officer of QED Therapeutics. "We anticipate this study being conducted by the Ivy Center will generate valuable information on the ability of infigratinib to reach brain tumors, which is a critical first step in evaluating whether infigratinib, alone or in combination, could potentially provide a therapeutic option for patients with this dire disease."

   For additional information on this Phase 0/2 trial in recurrent high-grade glioma, including eligibility criteria, visit www.clinicaltrials.gov/ct2/show/NCT04424966.

   About Ivy Brain Tumor Center

   Ivy Brain Tumor Center at the Barrow Neurological Institute in Phoenix, AZ is a non-profit translational research program that employs a bold, early-phase clinical trials strategy to identify new treatments for aggressive brain tumors, including glioblastoma. The Ivy Center's Phase 0 clinical trials program is the largest of its kind in the world and enables personalized care in a fraction of the time and cost associated with traditional drug development. Unlike conventional clinical trials focusing on single drugs, its accelerated trials program tests therapeutic combinations matched to individual patients. Learn more at IvyBrainTumorCenter.org. Follow the Ivy Brain Tumor Center on Facebook, Instagram, Twitter and LinkedIn.

   About QED Therapeutics, Inc.

   QED Therapeutics, an affiliate of BridgeBio Pharma, Inc. is a biotechnology company focused on precision medicine for FGFR-driven diseases. Our lead investigational candidate is infigratinib (BGJ398), an orally administered, FGFR1-3 selective tyrosine kinase inhibitor that has shown activity that we believe 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 intends to submit 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. We plan 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 on QED Therapeutics, please visit the Company's website at www.qedtx.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 bridgebio.com

   BridgeBio Pharma Forward Looking Statements

   This press release contains forward-looking statements. All statements contained herein other than statements of historical fact constitute forward-looking statements, including statements relating to expectations, plans, and prospects regarding QED Therapeutics' clinical development plans, clinical trial results, timing, completion and outcomes of clinical trials, including this investigator-initiated trial, the competitive environment, the success of QED Therapeutics' collaboration with the Ivy Brain Tumor Center and its impact on QED Therapeutics' clinical development strategy, and the clinical and therapeutic potential of infigratinib. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to, QED Therapeutics' ability to initiate and continue its planned clinical trials of infigratinib, its ability to advance infigratinib in clinical development, the timing and success of any such continued clinical development, and the Ivy Brain Tumor Center's ability to initiate and enroll its investigator-initiated clinical trial of infigratinib and the nature of QED's interactions with regulatory authorities. Moreover, QED Therapeutics 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 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. All forward-looking statements in this press release are based on information available to QED Therapeutics as of the date hereof, and QED Therapeutics disclaims any obligation to update these forward-looking statements.

   MEDIA:
   
   Ivy Brain Tumor Center
   
   Melinda Langdon
   
   Director, Marketing and Communications
   
   (623) 297-1317
   
   

   QED Therapeutics
   
   Ian Stone
   
   Canale Communications
   
   619-849-5388
   
   

   

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5. 15 July 2020 BridgeBio Pharma's QED Therapeutics Doses First Child in Phase 2 Clinical Trial of the Investigational Medicine Infigratinib in Achondroplasia

   SAN FRANCISCO, July 15, 2020 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) affiliate QED Therapeutics announced today that the first child with achondroplasia has been dosed with the investigational medicine infigratinib, an orally available small molecule, that targets the overactivity of fibroblast growth factor receptor 3 (FGFR3) in the PROPEL 2 Phase 2 clinical trial. Achondroplasia is the most common cause of disproportionate short stature.¹
   

   "With preclinical evidence showing increased growth in the long bones, spine and cranial bones, including the base of the skull, there is the potential for infigratinib to help children with achondroplasia by decreasing the impact of serious medical complications," said Professor Ravi…

   SAN FRANCISCO, July 15, 2020 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) affiliate QED Therapeutics announced today that the first child with achondroplasia has been dosed with the investigational medicine infigratinib, an orally available small molecule, that targets the overactivity of fibroblast growth factor receptor 3 (FGFR3) in the PROPEL 2 Phase 2 clinical trial. Achondroplasia is the most common cause of disproportionate short stature.¹
   
   

   "With preclinical evidence showing increased growth in the long bones, spine and cranial bones, including the base of the skull, there is the potential for infigratinib to help children with achondroplasia by decreasing the impact of serious medical complications," said Professor Ravi Savarirayan, M.B., B.S., M.D., Ph.D., clinical geneticist and group leader of skeletal biology and disease at Murdoch Children's Research Institute in Australia and the lead investigator for the PROPEL 2 trial. "Additionally, infigratinib is being studied as a once-daily dose taken orally, which is an important factor for administration of therapies to children with achondroplasia."

   Achondroplasia is caused by an alteration in the FGFR3 gene, which causes the FGFR3 protein to be overly active.¹ This interferes with skeletal development and can lead to disturbances in bone growth.¹ Infigratinib is an oral investigational medicine that is designed to reduce the activity of FGFR3.

   "The start of this clinical trial is the culmination of more than two years of work – first to secure rights to develop infigratinib, which we pursued following the publication of data relating to its potential in achondroplasia, and then to establish preclinical data showing the efficacy and safety of very low doses of the molecule," said Michael Henderson, M.D., CEO of QED Therapeutics. "Infigratinib illustrates the heart of what BridgeBio set out to do: leverage the highest quality science to identify and develop potential therapies that target genetically driven conditions at their source. Our hope is that a daily, oral dose of infigratinib, which directly targets FGFR3, can provide health benefits for children with achondroplasia."

   The PROPEL 2 trial is a Phase 2 dose escalation and dose expansion trial and the first clinical trial to study infigratinib at low doses in children with achondroplasia. The goal of the study is to assess safety and measure changes from baseline in annualized height velocity and changes in other health factors. To be eligible for the trial, children must first complete a six-month period of assessment in the PROPEL prospective clinical assessment study.

   About QED Therapeutics

   QED Therapeutics, an affiliate of BridgeBio Pharma, is a biotechnology company focused on precision medicine for FGFR-driven diseases. Our lead investigational candidate is infigratinib (BGJ398), an orally administered, FGFR1-3 selective tyrosine kinase inhibitor that we are evaluating in clinical studies for the treatment of achondroplasia. We plan to conduct further clinical trials to evaluate the potential for infigratinib to treat patients with FGFR-driven tumor types and rare disorders. At much higher doses, infigratinib has shown activity that we believe 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 intends to submit a New Drug Application (NDA) with the United States Food and Drug Administration (FDA) for second and later-line cholangiocarcinoma in 2020.

   For more information on QED Therapeutics, please visit the company's website at www.qedtx.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 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, expectations, plans, and potential success of QED Therapeutics' Phase 2 PROPEL 2 clinical trial, the regulatory approval process, clinical trial designs, clinical development plans, clinical trial results, timing and completion of the PROPEL 2 and other clinical trials, clinical and therapeutic potential of infigratinib for the treatment of achondroplasia or other FGFR-driven diseases, 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 Therapeutics' ability to continue or complete its Phase 2 PROPEL 2 clinical trial, ongoing and planned clinical trials of infigratinib for the potential treatment of achondroplasia and other FGFR-driven, the availability of data from these trials, past data from preclinical and earlier clinical studies not being indicative of future data from clinical trials, its ability to advance infigratinib in clinical development according to its plans, and the timing of these events, as well as those risks 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. Moreover, QED Therapeutics 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.

   ^{1.   National Institutes of Health. https://ghr.nlm.nih.gov/condition/achondroplasia. Accessed June 23, 2020.}

   QED Contact:
   
   Carolyn Hawley
   
   Canale Communications
   
   
   
   858-354-3581

   

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