BridgeBio Pharma, Inc. and Eidos Therapeutics, Inc. Announce January 21, 2021 Election Deadline for Merger

PALO ALTO and SAN FRANCISCO, CA – January 13, 2021 – 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

BridgeBio Pharma Reports Inducement Grants under Nasdaq Listing Rule 5635(c)(4)

Palo Alto, CA, January 6, 2021 — 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.

Leading Independent Proxy Advisory Firm ISS Recommends BridgeBio Pharma and Eidos Therapeutics Stockholders Vote “FOR” Proposed Merger

PALO ALTO, CA, January 4, 2021 – 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.

UCSF and BridgeBio Pharma Collaborate to Accelerate the Development of Therapies for Genetic Diseases

SAN FRANCISCO – December 23, 2020 – 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

BridgeBio Pharma and Maze Therapeutics Establish Joint Venture to Advance Precision Medicine to Treat Cardiovascular Disease

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 and SOUTH SAN FRANCISCO, Dec. 7, 2020 – 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

BridgeBio Pharma Reports Inducement Grants under Nasdaq Listing Rule 5635(c)(4)

Palo Alto, CA, December 4, 2020 — 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.

BridgeBio Pharma and Affiliate QED Therapeutics Announce FDA Acceptance of New Drug Application for Infigratinib for the Treatment of Cholangiocarcinoma

  • 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, CA – December 1, 2020 – 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

BridgeBio Pharma and Affiliate Navire Pharma Announce Dosing of First Patient in Phase 1 Clinical Trial of SHP2 inhibitor BBP-398 for Tumors Driven by RAS and Receptor Tyrosine Kinase Mutations

San Francisco – November 13, 2020 – 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, 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.

BridgeBio Pharma, Inc. Reports Third Quarter 2020 Financial Results And Business Update

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, NOVEMBER 5, 2020 – 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.
  • Encaleret – CaSR 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.

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.

BridgeBio Pharma Reports Inducement Grants under Nasdaq Listing Rule 5635(c)(4)

Palo Alto, CA, November 4, 2020 — 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.