BBIO BridgeBio Pharma Inc.

51.13
+0.89  (+2%)
Previous Close 50.24
Open 50.99
52 Week Low 14.23
52 Week High 50.09
Market Cap $6,266,912,884
Shares 122,568,216
Float 51,422,504
Enterprise Value $5,930,893,171
Volume 848,648
Av. Daily Volume 787,169
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Upcoming Catalysts

Drug Stage Catalyst Date
Fosdenopterin (BBP-870/ORGN001)
Molybdenum cofactor deficiency type A
PDUFA priority review
PDUFA priority review
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BBP-831 (infigratinib)
Cholangiocarcinoma
PDUFA priority review
PDUFA priority review
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Low-dose infigratinib (PROPEL2)
Achondroplasia
Phase 2
Phase 2
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Encaleret
Autosomal Dominant Hypocalcemia Type 1 (ADH1)
Phase 2
Phase 2
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BBP-631
Congenital adrenal hyperplasia (CAH
Phase 1/2
Phase 1/2
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Acoramidis (AG10) - ATTRibute-CM
ATTR-CM
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
BBP-589
Epidermolysis bullosa
Phase 1/2
Phase 1/2
Phase 1/2 trial ongoing.
BBP-398
Solid tumors
Phase 1
Phase 1
Phase 1 initiation of dosing announced November 13, 2020.
AG10 / BBP-265
ATTR-PN
Phase 2
Phase 2
Phase 3 trial has been initiated.
Infigratinib
Recurrent Glioblastoma
Phase 2
Phase 2
Phase 0/2 trial initiation announced July 28, 2020.
BBP-009/Patidegib
High-Frequency Basal Cell Carcinoma
Phase 2
Phase 2
Phase 2 trial initiation announced January 8, 2020.
BBP-418
Healthy volunteers
Phase 1
Phase 1
Phase 1 trial has been initiated - noted June 11, 2020.
BBP-009/Patidegib
Gorlin syndrome
Phase 3
Phase 3
Phase 3 completion of enrolment announced December 2, 2019.
Infigratinib
Solid tumors
Phase 2
Phase 2
Phase 2 trial initiation announced March 12, 2020.
Infigratinib (PROOF 302)
Urothelial Carcinoma
Phase 3
Phase 3
Phase 3 trial initiation announced March 12, 2020.

Latest News

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

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

    •  Application accepted under Priority Review designation

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

    •  This is BridgeBio's second NDA acceptance

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

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

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

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

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

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

    About Infigratinib

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

    About QED Therapeutics

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

    About BridgeBio Pharma, Inc.

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

    BridgeBio Pharma Forward-Looking Statements

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

    Contact:

    Grace Rauh

    BridgeBio Pharma, Inc.



    (917) 232-5478



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

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

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

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

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

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

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

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

    About BridgeBio Pharma

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

    About Navire Pharma

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



    BridgeBio Pharma Forward-Looking Statements

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

    Contact:

    Grace Rauh

    BridgeBio Pharma



    917-232-5478

    Source: BridgeBio Pharma, Inc.

     

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

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

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

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

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

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

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

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



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

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

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

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

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

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

    Recent pipeline progress and corporate updates:

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



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



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



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

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

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



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



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



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

    Third quarter 2020 financial results:

    Cash, Cash Equivalents and Marketable Securities

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

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

    Operating Expenses

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

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

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

     
    BRIDGEBIO PHARMA, INC.

    Condensed Consolidated Statements of Operations

    (in thousands, except shares and per share amounts)


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

    (Unaudited)
     

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

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

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

      redeemable convertible

      noncontrolling interests and

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

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

       computing net loss per share,

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



     
    BRIDGEBIO PHARMA, INC.

    Condensed Consolidated Balance Sheets

    (In thousands)


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

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

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



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

     
       

    About BridgeBio Pharma, Inc.

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

    BridgeBio Pharma Forward-Looking Statements

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

    Contact:

    Grace Rauh

    BridgeBio Pharma

            

    917-232-5478

    Source: BridgeBio Pharma, Inc.

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

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

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

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

    About BridgeBio

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

    Media Contact:

    Grace Rauh



    (917) 232-5478

    Investor Contact:

    John Grimaldi, Burns McClellan



    212-213-0006 ext. 362

    Source: BridgeBio Pharma, Inc. 

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

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

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

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

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

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

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

    About BridgeBio Pharma

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

    About the University of Colorado Anschutz Medical Campus

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

    About CU Innovations

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

    BridgeBio Pharma Forward-Looking Statements

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

    BridgeBio Contact:

    Grace Rauh

    BridgeBio Pharma, Inc.



    (917) 232-5478

    University of Colorado School of Medicine Contact:

    Rolfe Bautista

    Marketing Analyst | CU Innovations

    University of Colorado Anschutz Medical Campus



    (303) 724-1068

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