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1. 27 July 2021 BridgeBio Announces Clinical Collaboration with Bristol Myers Squibb to Study BBP-398, a Potentially Best-in-class SHP2 Inhibitor, in Combination with OPDIVO® (nivolumab) in Advanced Solid Tumors with KRAS Mutations

   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 KRAS^G12C 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 KRAS^G12C, 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 KRAS^G12C 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.
   
   
   
   (917) 232-5478

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2. 12 July 2021 BridgeBio Pharma Reports Inducement Grants under Nasdaq Listing Rule 5635(c)(4)

   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
   
   
   
   (917) 232-5478

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

   SOURCE BridgeBio

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3. 08 July 2021 BridgeBio Pharma Announces Collaborations with Three Academic Research Institutions

   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.
   
   
   
   (917) 232-5478

   View original content to download multimedia:https://www.prnewswire.com/news-releases/bridgebio-pharma-announces-collaborations-with-three-academic-research-institutions-301327529.html

   SOURCE BridgeBio

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4. 28 June 2021 BIOMEA Fusion Strengthens its Executive Team with Appointment of Franco Valle as Chief Financial Officer

   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.
   
   
   
   Phone: 805-455-1313

   
   
   

   

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5. 14 June 2021 BridgeBio Pharma Reports Inducement Grants under Nasdaq Listing Rule 5635(c)(4)

   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
   
   
   
   (917) 232-5478

   Source: BridgeBio Pharma, Inc.

   
   
   

   

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