8-K
false 0001743881 0001743881 2023-05-04 2023-05-04

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 4, 2023

 

 

BridgeBio Pharma, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-38959   84-1850815

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

3160 Porter Dr., Suite 250

Palo Alto, CA

  94304
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (650) 391-9740

Not Applicable

(Former name or former address, if changed since last report.)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading
Symbol(s)

 

Name of each exchange

on which registered

Common stock, par value $0.001 per share   BBIO   The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 


Item 2.02.

Results of Operations and Financial Condition.

On May 4, 2023, BridgeBio Pharma, Inc. reported recent business updates and its financial results for the first quarter ended March 31, 2023. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in Item 2.02 of this Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such a filing.

 

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit

Number

   Description
99.1    Press Release dated May 4, 2023, furnished herewith
104    Cover Page Interactive Data File (embedded within the Inline XBRL document)


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

      BridgeBio Pharma, Inc.
Date: May 4, 2023      

/s/ Brian C. Stephenson

      Brian C. Stephenson
      Chief Financial Officer
EX-99.1

Exhibit 99.1

BridgeBio Pharma Reports First Quarter 2023 Financial Results and Business Update

- Phase 3 ATTRibute-CM registrational trial of acoramidis for transthyretin amyloid cardiomyopathy (ATTR-CM) has now completed last patient last visit and remains on track for topline month 30 registrational data to be announced in late July 2023

- Positive results announced in Cohort 5 of Phase 2 PROPEL 2 trial of low-dose infigratinib in children with achondroplasia, demonstrating mean increase in annualized height velocity (AHV) of 3.03cm/year with no treatment-related adverse events. This data suggests a potential best-in-class efficacy and well-tolerated safety profile for infigratinib, which also has a differentiated convenience profile due to its oral route of administration

- Shared preliminary findings on novel bioassay measuring glycosylated alpha-dystroglycan (αDG) in patients with limb-girdle muscular dystrophy type 2I (LGMD2I) and 15-month results from ongoing Phase 2 study of BBP-418 for LGMD2I; continuing to progress towards 2023 initiation of a global Phase 3 registrational clinical trial of BBP-418 for LGMD2I

- Phase 3 CALIBRATE registrational trial of encaleret in autosomal dominant hypocalcemia type 1 (ADH1) continues to proceed, with topline data expected to be announced in the first half of 2024

- Phase 1/2 trial of BBP-631 for treatment of congenital adrenal hyperplasia (CAH) progressing with a data update planned by the end of 2023

- Three lead KRAS programs are progressing, with an Investigational New Drug (IND) application planned for first-in-class direct KRASG12C (ON) inhibitor BBO-8520 in second half of 2023

- Closed underwritten public offering with gross proceeds of approximately $150 million, and ended the quarter with $467 million in cash, cash equivalents, marketable securities, and restricted cash (current), providing runway into 2H 2024

Palo Alto, CA – May 4, 2023 – BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio or the Company), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today reported its financial results for the first quarter ended March 31, 2023 and provided an update on the Company’s operations.


‘‘We were excited to announce the results from the 5th cohort of our Phase 2 trial of infigratinib for achondroplasia – an oral agent with a well-tolerated safety profile and best-in-class efficacy to date,” said Neil Kumar, Ph.D., founder and CEO of BridgeBio. “We thank the children and physicians who have partnered with us on this study and are eager to take the next steps for this program together. Infigratinib pairs with our ADH1 program, which reads out its Phase 3 next year, to form a high-quality endocrine franchise that we are continuing to build out. With this dataset for achondroplasia in hand, we look forward to July and the next big readout from our pipeline, the 30-month data from our ATTR-CM Phase 3 trial of acoramidis that recently completed last patient last visit. We thank the ATTR-CM patient and physician communities who made this trial possible, and we look forward to sharing the results with you.”

BridgeBio’s key programs:

 

   

Acoramidis (AG10) – Transthyretin (TTR) stabilizer for transthyretin amyloid cardiomyopathy (ATTR-CM):

 

     

The Phase 3 ATTRibute-CM study has completed last patient last visit.

 

     

The Company expects to announce topline registrational data for the month 30 primary endpoint, a hierarchical composite including all-cause mortality and cardiovascular-related hospitalizations, in late July, 2023.

 

   

Low-dose infigratinib – FGFR1-3 inhibitor for achondroplasia and hypochondroplasia:

 

     

In March 2023, the Company reported data from the fifth dosing cohort of the Phase 2 dose-escalation trial PROPEL 2, demonstrating a mean change from baseline in annualized height velocity (AHV) of +3.03 cm/year for the ten children that have had six-month visits.

 

     

80% of the ten children with six-month visits in the fifth cohort were responders, as defined by an increase from baseline AHV of at least 25%.

 

     

As a result of treatment, the median absolute AHV reached 7.6 cm/yr, which is beyond the 99th percentile of growth for children living with achondroplasia.

 

     

Combined with the previously reported Cohort 4 change from baseline in AHV value of +1.52 cm/yr, the Cohort 5 data demonstrate a strong dose response for infigratinib.

 

     

To date, the study has shown a well-tolerated safety profile, with no study drug related treatment emergent adverse events (TEAEs) in Cohort 5. No serious adverse events (SAEs) or discontinuations due to AEs were reported in any cohort.

 

     

The Company has begun enrolling children in the run-in for a registrational Phase 3 trial.

 

     

The Company believes infigratinib, if approved, has the potential to capture a significant share of the market based on blinded market research.

 

   

BBP-418 – Glycosylation substrate for limb-girdle muscular dystrophy type 2I (LGMD2I):

 

     

The Company announced development of a validated novel bioassay that directly measures glycosylated αDG, which is central to LGMD2I disease and enables monitoring of responses to disease-modifying therapies in LGMD2I patients.


     

The Company also reported positive 15-month results from the ongoing Phase 2 clinical trial in October 2022, showing a doubling of glycosylated αDG in LGMD2I patients treated with BBP-418; a sustained decrease of ≥70% in creatine kinase (CK), a marker of muscle breakdown; and improvements in ambulatory and clinical function measures after 15 months of treatment.

 

     

The Company intends to initiate a global Phase 3 registrational trial of BBP-418 for LGMD2I in mid-2023, and has engaged with regulatory authorities to align on a trial design.

 

     

BBP-418 has a potentially-addressable population of 7,000 patients in the United States and European Union.

 

     

There are currently no disease-modifying treatments available for LGMD2I.

 

   

Encaleret – Calcium-sensing receptor (CaSR) inhibitor for autosomal dominant hypocalcemia type 1 (ADH1):

 

     

The pivotal Phase 3 CALIBRATE trial of encaleret for ADH1 continues to proceed.

 

     

Population genetics analyses estimate approximately 25,000 carriers of gain-of-function variants of the CaSR, the underlying cause of ADH1, in the United States and European Union.

 

     

The Company anticipates sharing topline data from CALIBRATE in the first half of 2024.

 

     

If approved, encaleret could be the first therapy specifically indicated for the treatment of ADH1.

 

   

BBP-631 – AAV5 gene therapy candidate for congenital adrenal hyperplasia (CAH):

 

     

The Phase 1/2 gene therapy trial of BBP-631 for CAH continued to progress; as of February 1, 2023, BBP-631 has been generally well-tolerated in four patients treated at the first two dose levels.

 

     

The Company plans to provide a data update by the end of 2023.

 

     

CAH is one of the most prevalent genetic diseases potentially addressable with adeno-associated virus (AAV) gene therapy, with more than 75,000 cases estimated in the United States and European Union.

 

   

RAS cancer portfolio:

 

     

BridgeBio is continuing to develop the three main programs of its RAS franchise:

 

   

BBO-8520, an investigational, next-generation small molecule direct KRASG12C(ON) inhibitor candidate that is designed to directly bind and inhibit KRASG12C in both its ON (GTP-bound) and OFF (GDP-bound) conformations, which remains on track to file an IND and enter the clinic in the second half of 2023.

 

   

A PI3Kα:RAS breaker program, investigational small molecules that are designed to block Ras-driven PI3Kα activation with a novel and potentially broad mechanism of action to target not only PI3Kα mutant tumors and RAS mutant tumors, but potentially other tumors driven by RTK activation of RAS signaling. The Company remains on track to select a development candidate in 2023, with IND filing to follow in 2024.


   

The Company’s pan-KRAS program, which targets multiple KRAS mutants including KRASG12D and KRASG12V, which are present in a large percentage of colorectal, pancreatic, and non-small cell lung cancer tumors. Development candidate selection for this program is planned for late 2023 or early 2024.

Corporate Update:

 

   

Follow-on offering:

 

     

The Company closed an underwritten public offering of shares of its common stock with gross proceeds of approximately $150 million.

First Quarter 2023 Financial Results:

Cash, Cash Equivalents, Marketable Securities and Restricted Cash (Current)

Cash, cash equivalents, marketable securities and restricted cash (current), totaled $467.0 million as of March 31, 2023, compared to $466.2 million as of December 31, 2022. The net increase of $0.8 million in cash, cash equivalents, marketable securities and restricted cash (current) is primarily attributable to the net proceeds received of $143.0 million from the follow-on public offering, and proceeds from common stock issuance under ESPP and stock option exercises of $2.0 million, partially offset by net cash used in operating activities of $144.3 million.

Operating Costs and Expenses

Operating costs and expenses decreased by $47.4 million to $128.0 million for the three months ended March 31, 2023, compared to $175.4 million for the same period in the prior year. The overall decrease in operating costs and expenses for the first quarter of 2023 compared to the comparative period was mainly due to decreases in research, development and other (R&D) expenses of $15.5 million resulting from the Company’s reprioritization of its R&D programs; selling, general and administrative expenses of $12.6 million resulting from its company-wide streamlining of costs; and restructuring, impairment and related charges of $19.3 million since the majority of the restructuring initiatives were initiated in the first quarter of 2022. The effects of the Company’s restructuring initiative that was started in the first quarter of 2022 are continuing to be realized due to the Company’s reductions in its operating costs and expenses. Restructuring, impairment and related charges for the three months ended March 31, 2023 of $3.4 million, were primarily comprised of winding down, exit and other related costs. Restructuring, impairment and related charges for the same period in prior year were $22.7 million, were primarily related to impairments and write-offs of long-lived assets, severance and employee-related costs, and exit and other related costs. The Company continues to evaluate restructuring alternatives to drive operational changes in business processes, efficiencies, and cost savings.


Stock-based compensation expenses included in operating costs and expenses for the first quarter of 2023 were $23.5 million, of which $11.8 million is included in research, development and other (R&D) expenses, $11.7 million is included in selling, general and administrative expenses, and nil is included in restructuring, impairment and related charges. Stock-based compensation expenses included in operating costs and expenses for the first quarter of 2022 were $24.3 million, of which $8.6 million is included in research, development and other (R&D) expenses, $14.6 million is included in selling, general and administrative expenses, and $1.2 million is included in restructuring, impairment and related charges.

“Strengthening our balance sheet through our recent $150 million follow-on offering extends our runway into the second half of 2024, and puts us in a strong position to take advantage of our optionality as we head into this summer’s ATTR-CM readout,” said Brian Stephenson, Ph.D., CFA, Chief Financial Officer of BridgeBio. “We will continue to explore ways to extend our runway further through considering potential partnerships and royalty transactions.”

BRIDGEBIO PHARMA, INC.

Condensed Consolidated Statements of Operations

(in thousands, except shares and per share amounts)

 

     Three Months Ended March 31,  
     2023     2022  
     (Unaudited)  

Revenue

   $ 1,826     $ 1,694  

Operating costs and expenses:

    

Research, development and others

     93,512       108,997  

Selling, general and administrative

     31,108       43,713  

Restructuring, impairment and related charges

     3,369       22,662  
  

 

 

   

 

 

 

Total operating costs and expenses

     127,989       175,372  
  

 

 

   

 

 

 

Loss from operations

     (126,163     (173,678

Other income (expense), net:

    

Interest income

     4,153       267  

Interest expense

     (20,121     (20,344

Other expense, net

     (601     (7,575
  

 

 

   

 

 

 

Total other income (expense), net

     (16,569     (27,652
  

 

 

   

 

 

 

Net loss

     (142,732     (201,330

Net loss attributable to redeemable convertible noncontrolling interests and noncontrolling interests

     2,576       4,933  
  

 

 

   

 

 

 

Net loss attributable to common stockholders
of BridgeBio

   $ (140,156   $ (196,397
  

 

 

   

 

 

 

Net loss per share, basic and diluted

   $ (0.92   $ (1.35
  

 

 

   

 

 

 

Weighted-average shares used in computing net
loss per share, basic and diluted

     152,645,635       145,882,149  
  

 

 

   

 

 

 

 

     Three Months Ended March 31,  

Stock-based Compensation

   2023      2022  
     (Unaudited)  

Research, development and others

   $ 11,779      $ 8,557  

Selling, general and administrative

     11,698        14,552  

Restructuring, impairment and related charges

     —          1,172  
  

 

 

    

 

 

 

Total stock-based compensation

   $ 23,477      $ 24,281  
  

 

 

    

 

 

 


BRIDGEBIO PHARMA, INC.

Condensed Consolidated Balance Sheets

(In thousands)

 

     March 31,     December 31,  
     2023     2022  
     (Unaudited)     (1)  

Assets

    

Cash and cash equivalents and marketable securities

   $ 441,490     $ 428,269  

Investment in equity securities

     49,803       43,653  

Receivable from licensing and collaboration agreements

     10,761       17,079  

Restricted cash

     25,503       37,930  

Prepaid expenses and other current assets

     25,145       21,922  

Property and equipment, net

     13,566       14,569  

Operating lease right-of-use assets

     10,532       10,678  

Intangible assets, net

     28,113       28,712  

Other assets

     20,767       20,224  
  

 

 

   

 

 

 

Total assets

   $ 625,680     $ 623,036  
  

 

 

   

 

 

 

Liabilities, Redeemable Convertible Noncontrolling Interests and Stockholders’ Deficit

    

Accounts payable

   $ 4,076     $ 11,558  

Accrued and other liabilities

     88,846       106,195  

Operating lease liabilities

     15,578       15,949  

2029 Notes

     735,463       734,988  

2027 Notes

     542,065       541,634  

Term loans

     435,764       430,993  

Other long-term liabilities

     17,501       26,643  

Redeemable convertible noncontrolling interests

     (204     (1,589

Total BridgeBio stockholders’ deficit

     (1,225,665     (1,254,617

Noncontrolling interests

     12,256       11,282  
  

 

 

   

 

 

 

Total liabilities, redeemable convertible noncontrolling interests and stockholders’ deficit

   $ 625,680     $ 623,036  
  

 

 

   

 

 

 

 

(1)

The condensed consolidated financial statements as of and for the year ended December 31, 2022 are derived from the audited consolidated financial statements as of that date.


BRIDGEBIO PHARMA, INC.

Condensed Consolidated Statements of Cash Flows

(In thousands)

 

     Three Months Ended
March 31,
 
     2023     2022  

Operating activities:

    

Net loss

   $ (142,732   $ (201,330

Adjustments to reconcile net loss to net cash used in operating activities:

    

Stock-based compensation

     21,907       24,122  

Depreciation and amortization

     1,633       1,884  

Noncash lease expense

     1,032       1,545  

Accrual of payment-in-kind interest on term loan

     3,339       —    

Loss on deconsolidation of PellePharm

     1,241       —    

Loss (gain) from investment in equity securities, net

     (964     12,866  

Accretion of debt

     2,338       2,483  

Fair value adjustment of warrants

     (111     852  

Loss on sale of certain assets

     —         6,261  

Impairment of long-lived assets

     —         12,653  

Gain from recognition of receivable from licensing and collaboration agreement

     —         (12,500

Other noncash adjustments

     (203     604  

Changes in operating assets and liabilities:

    

Receivable from licensing and collaboration agreements

     6,318       10,266  

Prepaid expenses and other current assets

     (3,542     (2,657

Other assets

     (483     7,901  

Accounts payable

     (3,800     (1,814

Accrued compensation and benefits

     (18,369     (16,876

Accrued research and development liabilities

     (2,556     (818

Accrued professional services

     2,225       (1,374

Operating lease liabilities

     (1,250     (1,820

Deferred revenue

     (1,748     —    

Other accrued and other long-term liabilities

     (8,597     (2,883
  

 

 

   

 

 

 

Net cash used in operating activities

     (144,322     (160,635

Investing activities:

    

Purchases of marketable securities

     —         (55,722

Maturities of marketable securities

     18,000       186,695  

Purchases of investment in equity securities

     (47,474     (8,162

Sales of investment in equity securities

     42,287       6,671  

Decrease in cash and cash equivalents resulting from deconsolidation of PellePharm

     (503     —    

Proceeds from sale of certain assets

     —         10,000  

Purchases of property and equipment

     (12     (859
  

 

 

   

 

 

 

Net cash provided by investing activities

     12,298       138,623  

Financing activities:

    

Proceeds from issuance of common stock through Follow-on offering, net

     143,016       —    

Proceeds from BridgeBio common stock issuances under ESPP

     1,809       966  

Repurchase of shares to satisfy tax withholding

     (512     (110

Issuance costs associated with term loan

     —         (1,120

Proceeds from stock option exercises, net of repurchases

     193       104  

Other financing activities

     5,743       —    
  

 

 

   

 

 

 

Net cash provided by (used in) financing activities

     150,249       (160
  

 

 

   

 

 

 

Net increase (decrease) in cash, cash equivalents and restricted cash

     18,225       (22,172

Cash, cash equivalents and restricted cash at beginning of period

     416,884       396,365  
  

 

 

   

 

 

 

Cash, cash equivalents and restricted cash at end of period

   $ 435,109     $ 374,193  
  

 

 

   

 

 

 


     Three Months Ended
March 31,
 
     2023     2022  

Supplemental Disclosures of Cash Flow Information:

    

Cash paid for interest

   $ 22,059     $ 18,809  
  

 

 

   

 

 

 

Supplemental Disclosures of Noncash Investing and Financing Information:

    
Payment-in-kind interest added to principal of term loan    $ —       $ 1,763  
  

 

 

   

 

 

 
Unpaid property and equipment    $ 96     $ 750  
  

 

 

   

 

 

 
Transfers to noncontrolling interests    $ (2,843   $ (317
  

 

 

   

 

 

 

Reconciliation of Cash, Cash Equivalents and Restricted Cash:

    

Cash and cash equivalents

   $ 407,368     $ 371,550  

Restricted cash

     25,503       —    

Restricted cash — Included in “Prepaid expenses and other current assets”

     —         177  

Restricted cash — Included in “Other assets”

     2,238       2,466  
  

 

 

   

 

 

 

Total cash, cash equivalents and restricted cash at end of period shown in the condensed consolidated statements of cash flows

   $ 435,109     $ 374,193  
  

 

 

   

 

 

 

About BridgeBio Pharma, Inc.

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

BridgeBio Pharma, Inc. Forward-Looking Statements

This press release contains forward-looking statements. Statements 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,” “on track”, “remains” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements, including statements relating to the clinical and therapeutic potential of our programs and product candidates, including the timing and success of our RAS program, including an IND application planned for first-in-class direct KRASG12C (ON) inhibitor BBO-8520 in second half of 2023, the timing of a Phase 3 trial of BBP-418 in patients with LGMD2I, intended to be initiated in mid-2023, and the potentially-addressable population of BBP-418 in the United States and European Union; the potential of infigratinib for achondroplasia to have a potential of best-in-class efficacy with well-tolerated safety profile and to capture a significant share of the market based on blinded market research, if approved; the timing and success of additional trials of encaleret for ADH1, including the continued proceeding of Phase 3 CALIBRATE trial of encaleret


for ADH1; the timing of announcement of topline data from CALIBRATE, expected in the first half of 2024; the success of encaleret (if approved), including its potential to be the first therapy specifically indicated for the treatment of ADH1; the availability and success of topline results from the month 30 endpoint of our Phase 3 ATTRibute-CM trial of acoramidis, expected in late July, 2023; the continuation and progress of our ongoing Phase 1/2 trial of BBP-631 for CAH, with a planned data update by the end of 2023; the continued evaluation of restructuring alternatives to drive operational changes in business processes, efficiencies, and cost savings, as well as our anticipated cash runway, reflect our current views about our plans, intentions, expectations and strategies, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, initial and ongoing data from our preclinical studies and clinical trials not being indicative of final data, the potential size of the target patient populations our product candidates are designed to treat not being as large as anticipated, the design and success of ongoing and planned clinical trials, future regulatory filings, approvals and/or sales, despite having ongoing and future interactions with the FDA or other regulatory agencies to discuss potential paths to registration for our product candidates, the FDA or such other regulatory agencies not agreeing with our regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted, the continuing success of our collaborations, the Company’s ability to obtain additional funding under our credit facility, potential volatility in our share price, uncertainty regarding any impacts due to COVID-19, such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy, the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine, increasing rates of inflation and rising interest rates, on business operations and expectations, as well as those risks set forth in the Risk Factors section of our Annual Report on Form 10-K for the year ended December 31, 2022 and our other filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

BridgeBio Contact:

Vikram Bali

contact@bridgebio.com

(650)-789-8220