UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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(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:
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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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:
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Trading |
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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 August 1, 2024, BridgeBio Pharma, Inc. reported recent business updates and its financial results for the second quarter ended June 30, 2024. 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 |
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Description |
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99.1 |
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104 |
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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.
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BridgeBio Pharma, Inc. |
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Date: |
August 1, 2024 |
By: |
/s/ Brian C. Stephenson |
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Brian C. Stephenson, Ph.D., CFA |
Exhibit 99.1
BridgeBio Pharma Reports Second Quarter 2024 Financial Results and Business Update
- Acoramidis demonstrated a significant impact on mortality, hospitalizations, and quality of life
- Starting at Month 3, patients taking acoramidis showed meaningful and sustained improvement
in time to first event (CVH or ACM)
- Acoramidis demonstrated a 42% reduction in composite CVH and ACM events
relative to placebo by Month 30
- Increased serum TTR levels by Day 28 were correlated with a reduced risk of events
(ACM, CVM, and CVH) through Month 30
- Acoramidis resulted in a statistically significant reduction in ACM in the intention-to-treat (ITT) population at Month 30
- Shared +2.50 cm/yr annualized height velocity (AHV) at Month 18 in Cohort 5 of PROPEL 2, the Phase 2 study of infigratinib in achondroplasia, as well as the first ever reported statistically significant improvement in body proportionality
- The first child consented in ACCEL, the observational run-in study for infigratinib in children living with hypochondroplasia, a skeletal dysplasia closely related to achondroplasia
- The Company surpassed its interim analysis enrollment target for its Phase 3 FORTIFY study of BBP-418 in individuals living with limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9)
- The Company ended the quarter with $587 million in cash, cash equivalents, marketable securities and short-term restricted cash
Palo Alto, CA – August 1, 2024 – BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio or the Company), a commercial-stage biopharmaceutical company focused on genetic diseases, today reported its financial results for the second quarter ended June 30, 2024, and provided an update on the Company’s operations.
“Our team has continued its preparation for the commercial launch of acoramidis while also executing against our goal of fully enrolling our three Phase 3 clinical programs by the end of 2024. We are well positioned to launch acoramidis and achieve three readouts in 2025. Our differentiated capability to develop multiple candidates for genetic-based diseases provides a unique opportunity to create significant value for patients and shareholders,” said Dr. Neil Kumar, CEO and Founder of BridgeBio.
Pipeline overview:
Program |
Status |
Next expected milestone |
Acoramidis for ATTR-CM |
NDA filed with FDA |
November 29, 2024 PDUFA date |
Encaleret for ADH1 |
Enrolling CALIBRATE, Phase 3 study |
Enrollment completion in 2024 |
BBP-418 for LGMD2I/R9 |
Enrolling FORTIFY, Phase 3 study |
Enrollment completion in 2024 |
Low-dose infigratinib for achondroplasia |
Enrolling PROPEL 3, Phase 3 study |
Enrollment completion in 2024 |
Low-dose infigratinib for hypochondroplasia |
Enrolling observational run-in for ACCEL 2, Phase 2 study |
Enrollment completion date to be announced |
BBP-631 for congenital adrenal hyperplasia (CAH) |
Dose finding / analysis in Phase 2 study |
Program update in August 2024 |
1
BBP-812 for Canavan disease |
Enrolling at high dose in Phase 1/2 study |
Key regulatory interactions |
Program updates:
2
Second Quarter 2024 Financial Results:
Cash, Cash Equivalents, Marketable Securities and Short-term Restricted Cash
Cash, cash equivalents, marketable securities and short-term restricted cash, totaled $587.2 million as of June 30, 2024, compared to $392.6 million of cash, cash equivalents and short-term restricted cash as of December 31, 2023. The $194.6 million net increase in cash, cash equivalents, marketable securities and short-term restricted cash was primarily attributable to net proceeds received from the term loan under the credit facility with Blue Owl of $434.0 million, net proceeds received from various equity financings of $314.8
3
million, proceeds from the sale of investments in equity securities of $63.2 million, and special cash dividends received from investments in equity securities of $25.7 million. These were primarily offset by refinancing of the Company’s previous senior secured credit term loan, inclusive of prepayment fees and exit-related costs in aggregate of $473.4 million, net cash used in operating activities of $144.8 million, purchases of equity securities of $20.3 million, and repurchase of shares to satisfy tax withholdings of $4.7 million during the six months ended June 30, 2024.
Revenue
Revenue for the three and six months ended June 30, 2024 were $2.2 million and $213.3 million, respectively, as compared to $1.6 million and $3.5 million for the same periods in the prior year.
The increase of $0.6 million in revenue for the three months ended June 30, 2024, compared to the same period in the prior year, was primarily due to the recognition of services revenue under the exclusive license and collaboration agreements with Bayer and Kyowa Kirin. Revenue for the three months ended June 30, 2023 primarily consists of the recognition of services revenue under the Navire-BMS License Agreement, which terminated effective June 2024.
The increase of $209.8 million in revenue for the six months ended June 30, 2024, compared to the same period in the prior year, was primarily due to $202.9 million from recognition of non-refundable upfront payments and service revenue under the Bayer and the Kyowa Kirin exclusive license and collaboration agreements.
Operating Costs and Expenses
Operating costs and expenses for the three and six months ended June 30, 2024 were $177.7 million and $388.5 million, respectively, compared to $147.7 million and $275.7 million for the same periods in the prior year.
The overall increase of $30.0 million in operating costs and expenses for the three months ended June 30, 2024, compared to the same period in the prior year, was primarily due to an increase of $23.4 million in selling, general and administrative (SG&A) expenses mainly to support commercialization readiness efforts, an increase of $7.2 million in research and development and other expenses (R&D) to advance the Company’s pipeline of research and development programs, offset by a decrease of $0.6 million in restructuring, impairment and related charges.
The overall increase of $112.8 million in operating costs and expenses for the six months ended June 30, 2024, compared to the same period in the prior year, was primarily due to an increase of $58.1 million in SG&A expenses mainly to support commercialization readiness efforts, and an increase of $55.3 million in R&D expenses to advance the Company’s pipeline of research and development programs, offset by a decrease of $0.6 million in restructuring, impairment and related charges. Operating costs and expenses for the six months ended June 30, 2024, include $22.5 million of nonrecurring deal-related costs for transactions that were closed during the three months ended March 31, 2024.
Restructuring, impairment and related charges for the three and six months ended June 30, 2024 amounted to $2.9 million and $6.3 million, respectively. These charges primarily consisted of impairments and write-offs of long-lived assets, severance and employee-related costs, and exit and other related costs. Restructuring,
4
impairment and related charges for the same periods in the prior year was $3.5 million and $6.9 million, respectively. These charges primarily consisted of winding down, exit costs, and severance and employee-related costs.
Stock-based compensation expenses included in operating costs and expenses for the three months ended June 30, 2024 were $21.5 million, of which $4.9 million is included in R&D expenses, $16.5 million is included in SG&A expenses, and $0.1 million is included in Restructuring expenses. Stock-based compensation expenses included in operating costs and expenses for the same period in the prior year were $27.2 million, of which $13.2 million is included in R&D expenses, and $14.0 million is included in SG&A expenses.
Stock-based compensation expenses included in operating costs and expenses for the six months ended June 30, 2024 were $50.3 million, of which $17.7 million is included in R&D expenses, $32.5 million is included in SG&A expenses, and $0.1 million is included in Restructuring expenses. Stock-based compensation expenses included in operating costs and expenses for the same period in the prior year were $50.7 million, of which $25.0 million is included in R&D expenses, and $25.7 million is included in SG&A expenses.
Total Other Income (Expense), net
Total other income (expense), net for the three and six months ended June 30, 2024 were $100.0 million and $63.5 million, respectively, compared to ($14.6) million and ($31.2) million for the same periods in the prior year.
The increase in total other income (expense), net of $114.6 million for the three months ended June 30, 2024, compared to the same period in the prior year, was primarily due to the Company’s gain on deconsolidation of a subsidiary of $126.3 million. This was partially offset by a net loss from an equity method investment of $7.9 million and an increase in interest expense of $2.3 million.
The increase in total other income (expense), net of $94.7 million for the six months ended June 30, 2024, compared to the same period in the prior year, was primarily due to the Company’s gain on deconsolidation of a subsidiary of $126.3 million and an increase in other income (expense), net of $8.1 million mainly from income or mark to market fair value adjustments from the Company’s investments in equity securities. These were partially offset by a loss on extinguishment of debt of $26.6 million, a net loss from an equity method investment of $7.9 million and an increase in interest expense of $5.7 million.
Net Loss Attributable to Common Stockholders of BridgeBio and Net Loss per Share
For the three months and six months ended June 30, 2024, the Company recorded a net loss attributable to common stockholders of BridgeBio of $73.5 million and $108.7 million, respectively, compared to $157.9 million and $298.1 million, respectively for the three months and six months ended June 30, 2023.
For the three months and six months ended June 30, 2024, the Company reported a net loss per share of $0.39 and $0.59, respectively compared to $0.98 and $1.90, respectively for the three months and six months ended June 30, 2023.
5
BRIDGEBIO PHARMA, INC.
Condensed Consolidated Statements of Operations
(in thousands, except shares and per share amounts)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2024 |
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2023 |
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2024 |
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2023 |
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(Unaudited) |
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(Unaudited) |
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Revenue |
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$ |
2,168 |
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$ |
1,641 |
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$ |
213,288 |
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$ |
3,467 |
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Operating costs and expenses: |
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Research, development and other expenses |
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115,293 |
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108,087 |
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256,863 |
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201,599 |
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Selling, general and administrative |
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59,523 |
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36,122 |
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125,330 |
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67,230 |
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Restructuring, impairment and related charges |
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2,891 |
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3,531 |
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6,291 |
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6,900 |
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Total operating costs and expenses |
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177,707 |
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147,740 |
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388,484 |
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275,729 |
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Loss from operations |
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(175,539 |
) |
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(146,099 |
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(175,196 |
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(272,262 |
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Other income (expense), net: |
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Interest income |
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5,195 |
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4,514 |
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9,270 |
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8,667 |
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Interest expense |
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(22,937 |
) |
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(20,594 |
) |
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(46,408 |
) |
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(40,715 |
) |
Gain on deconsolidation of a subsidiary |
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126,294 |
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— |
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126,294 |
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— |
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Loss on extinguishment of debt |
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— |
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— |
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(26,590 |
) |
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— |
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Net loss from equity method investment |
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(7,925 |
) |
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— |
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(7,925 |
) |
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— |
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Other income (expense), net |
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(632 |
) |
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1,476 |
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8,851 |
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|
875 |
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Total other income (expense), net |
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99,995 |
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(14,604 |
) |
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63,492 |
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(31,173 |
) |
Net loss |
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(75,544 |
) |
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(160,703 |
) |
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(111,704 |
) |
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(303,435 |
) |
Net loss attributable to redeemable convertible |
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2,088 |
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2,804 |
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3,032 |
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|
5,380 |
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Net loss attributable to common stockholders |
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$ |
(73,456 |
) |
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$ |
(157,899 |
) |
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$ |
(108,672 |
) |
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$ |
(298,055 |
) |
Net loss per share, basic and diluted |
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$ |
(0.39 |
) |
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$ |
(0.98 |
) |
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$ |
(0.59 |
) |
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$ |
(1.90 |
) |
Weighted-average shares used in computing net |
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187,586,680 |
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160,535,435 |
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183,145,995 |
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156,645,838 |
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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Stock-based Compensation |
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2024 |
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2023 |
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2024 |
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2023 |
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(Unaudited) |
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(Unaudited) |
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Research, development and other expenses |
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$ |
4,937 |
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$ |
13,229 |
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$ |
17,716 |
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$ |
25,008 |
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Selling, general and administrative |
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16,471 |
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|
13,947 |
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32,542 |
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|
25,645 |
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Restructuring, impairment and related charges |
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43 |
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— |
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43 |
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— |
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Total stock-based compensation |
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$ |
21,451 |
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$ |
27,176 |
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$ |
50,301 |
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$ |
50,653 |
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6
BRIDGEBIO PHARMA, INC.
Condensed Consolidated Balance Sheets
(In thousands)
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June 30, |
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December 31, |
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2024 |
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2023 |
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Assets |
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(Unaudited) |
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(1) |
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Cash, cash equivalents and marketable securities |
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$ |
447,771 |
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$ |
375,935 |
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Investments in equity securities |
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— |
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58,949 |
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Receivables from licensing and collaboration agreements |
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660 |
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1,751 |
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Short-term restricted cash |
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139,409 |
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16,653 |
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Prepaid expenses and other current assets |
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28,396 |
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24,305 |
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Investment in nonconsolidated entity |
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117,006 |
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— |
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Property and equipment, net |
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9,840 |
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|
11,816 |
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Operating lease right-of-use assets |
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|
7,267 |
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|
8,027 |
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Intangible assets, net |
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25,123 |
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|
26,319 |
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Other assets |
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|
18,903 |
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|
22,625 |
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Total assets |
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$ |
794,375 |
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$ |
546,380 |
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Liabilities, Redeemable Convertible Noncontrolling Interests and Stockholders’ Deficit |
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Accounts payable |
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$ |
18,126 |
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$ |
10,655 |
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Accrued and other liabilities |
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96,517 |
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|
122,965 |
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Operating lease liabilities |
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|
11,682 |
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|
13,109 |
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Deferred revenue |
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32,059 |
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|
9,823 |
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2029 Notes, net |
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|
737,882 |
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|
736,905 |
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2027 Notes, net |
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|
544,270 |
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|
543,379 |
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Term loan, net |
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|
435,447 |
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|
446,445 |
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Other long-term liabilities |
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|
485 |
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|
5,634 |
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Redeemable convertible noncontrolling interests |
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|
(223 |
) |
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|
478 |
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Total BridgeBio stockholders' deficit |
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(1,092,925 |
) |
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(1,354,257 |
) |
Noncontrolling interests |
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|
11,055 |
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|
|
11,244 |
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Total liabilities, redeemable convertible noncontrolling interests and stockholders’ deficit |
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$ |
794,375 |
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$ |
546,380 |
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(1) |
The condensed consolidated financial statements as of and for the year ended December 31, 2023 are derived from the audited consolidated financial statements as of that date. |
7
BRIDGEBIO PHARMA, INC.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(In thousands)
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Six Months Ended June 30, |
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2024 |
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2023 |
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Operating activities: |
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Net loss |
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$ |
(111,704 |
) |
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$ |
(303,435 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
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Stock-based compensation |
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|
38,511 |
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|
|
49,085 |
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Loss on extinguishment of debt |
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|
26,590 |
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— |
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Accretion of debt |
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|
3,683 |
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|
|
4,580 |
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Depreciation and amortization |
|
|
3,170 |
|
|
|
3,270 |
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Noncash lease expense |
|
|
2,093 |
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|
|
2,024 |
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Accrual of payment-in-kind interest on term loan |
|
|
— |
|
|
|
6,742 |
|
Net loss from equity method investment |
|
|
7,925 |
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|
|
— |
|
Loss (gain) on deconsolidation of subsidiaries |
|
|
(126,294 |
) |
|
|
1,241 |
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Gain from investment in equity securities, net |
|
|
(8,136 |
) |
|
|
(2,399 |
) |
Fair value adjustment of warrants |
|
|
— |
|
|
|
(222 |
) |
Other noncash adjustments |
|
|
(1,911 |
) |
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|
(328 |
) |
Changes in operating assets and liabilities: |
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|
|
|
|
|
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Receivables from licensing and collaboration agreements |
|
|
1,091 |
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|
|
8,466 |
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Prepaid expenses and other current assets |
|
|
(6,506 |
) |
|
|
1,057 |
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Other assets |
|
|
942 |
|
|
|
32 |
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Accounts payable |
|
|
8,858 |
|
|
|
(4,098 |
) |
Accrued compensation and benefits |
|
|
(8,378 |
) |
|
|
(11,071 |
) |
Accrued research and development liabilities |
|
|
7,067 |
|
|
|
(11,322 |
) |
Operating lease liabilities |
|
|
(2,981 |
) |
|
|
(2,443 |
) |
Deferred revenue |
|
|
22,236 |
|
|
|
(3,184 |
) |
Accrued professional and other liabilities |
|
|
(1,090 |
) |
|
|
4,330 |
|
Net cash used in operating activities |
|
|
(144,834 |
) |
|
|
(257,675 |
) |
Investing activities: |
|
|
|
|
|
|
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Purchases of marketable securities |
|
|
(93,811 |
) |
|
|
(19,754 |
) |
Maturities of marketable securities |
|
|
55,000 |
|
|
|
41,550 |
|
Purchases of investments in equity securities |
|
|
(20,271 |
) |
|
|
(71,504 |
) |
Proceeds from sales of investments in equity securities |
|
|
63,229 |
|
|
|
67,068 |
|
Proceeds from special cash dividends received from investments in equity securities |
|
|
25,682 |
|
|
|
— |
|
Payment for an intangible asset |
|
|
(3,190 |
) |
|
|
— |
|
Purchases of property and equipment |
|
|
(749 |
) |
|
|
(440 |
) |
Decrease in cash and cash equivalents resulting from deconsolidation of subsidiaries |
|
|
(98 |
) |
|
|
(503 |
) |
Net cash provided by investing activities |
|
|
25,792 |
|
|
|
16,417 |
|
Financing activities: |
|
|
|
|
|
|
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Proceeds from term loan under Financing Agreement |
|
|
450,000 |
|
|
|
— |
|
Issuance costs and discounts associated with term loan under Financing Agreement |
|
|
(15,986 |
) |
|
|
— |
|
Repayment of term loan under Loan and Security Agreement |
|
|
(473,417 |
) |
|
|
— |
|
Proceeds from issuance of common stock through public offerings, net |
|
|
314,759 |
|
|
|
144,049 |
|
Proceeds from BridgeBio common stock issuances under ESPP |
|
|
2,364 |
|
|
|
1,809 |
|
Proceeds from stock option exercises, net of repurchases |
|
|
778 |
|
|
|
312 |
|
Repurchase of RSU shares to satisfy tax withholding |
|
|
(4,679 |
) |
|
|
(1,715 |
) |
Other financing activities |
|
|
— |
|
|
|
4,563 |
|
Net cash provided by financing activities |
|
|
273,819 |
|
|
|
149,018 |
|
Net increase (decrease) in cash, cash equivalents and restricted cash |
|
|
154,777 |
|
|
|
(92,240 |
) |
Cash, cash equivalents and restricted cash at beginning of period |
|
|
394,732 |
|
|
|
416,884 |
|
Cash, cash equivalents and restricted cash at end of period |
|
$ |
549,509 |
|
|
$ |
324,644 |
|
8
|
|
Six Months Ended June 30, |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
Supplemental Disclosure of Cash Flow Information: |
|
|
|
|
|
|
||
Cash paid for interest |
|
$ |
49,046 |
|
|
$ |
28,738 |
|
Supplemental Disclosures of Noncash Investing and Financing Information: |
|
|
|
|
|
|
||
Unpaid public offering issuance costs |
|
$ |
18 |
|
|
$ |
— |
|
Deferred and unpaid issuance costs recorded to "Accrued and other liabilities" |
|
$ |
74 |
|
|
$ |
— |
|
Unpaid property and equipment |
|
$ |
70 |
|
|
$ |
131 |
|
Transfers to noncontrolling interests |
|
$ |
(1,929 |
) |
|
$ |
(5,940 |
) |
Reconciliation of Cash, Cash Equivalents and Restricted Cash: |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
407,958 |
|
|
$ |
302,438 |
|
Restricted cash |
|
|
139,409 |
|
|
|
19,930 |
|
Restricted cash — Included in “Other assets” |
|
|
2,142 |
|
|
|
2,276 |
|
Total cash, cash equivalents and restricted cash at end of period shown in the |
|
$ |
549,509 |
|
|
$ |
324,644 |
|
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. 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,” “continues,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “projects,” “remains,” “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. These forward-looking statements, including statements relating to the clinical and therapeutic, market potential of the Company’s programs and product candidates, including the statements in Dr. Kumar’s quote regarding the potential commercial launch of acoramidis (if approved) and the Company’s goal of fully enrolling its three Phase 3 clinical programs, continued advancement in the Company’s pipeline, including enrollments in clinical trials and anticipated readouts, and other benefits resulting from recent financing activities; the statements related to the FDA’s planned actions regarding the Company’s NDA for acoramidis for the treatment of ATTR-CM; the potential outcomes of regulatory interactions with and reviews by the FDA and the European Medicines Agency; the timing and success of the Company’s clinical development programs, including the progress of the Company’s clinical development program for acoramidis for patients with ATTR-CM, and the Company’s plan for, and the expected timing of, initiation of ACT-EARLY, the Company’s planned acoramidis ATTR amyloidosis prevention trial; the potential payments we may receive under the recent license agreement with Bayer and Kyowa Kirin; the continuation of PROPEL 3, the Company’s Phase 3 study of infigratinib for achondroplasia and the expected timing for completion of the study; the Company’s commitment to exploring the potential of
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infigratinib and expectation regarding the Company’s clinical program for hypochondroplasia; the continuation and progress of FORTIFY, the Phase 3 trial of BBP-418 for LGMD2I/R9, including the expected receipt of top-line results from the interim analysis population, and the potential to pursue Accelerated Approval for BBP-418 based on recent interactions with the FDA; the Company’s ability to qualify for Priority Review Vouchers with respect to BBP-418 and infigratinib; the continued enrollment in CALIBRATE, the Phase 3 clinical trial of encaleret, and the timing for sharing topline data from CALIBRATE; and the Company’s financial performance, capitalization status, strategy, business plans and goals reflect the Company’s current views about the Company’s plans, intentions, expectations and strategies, which are based on the information currently available to us and on assumptions we have made. Although the Company believes that its 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 the Company’s preclinical studies and clinical trials not being indicative of final data, the potential size of the target patient populations the Company’s 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 the Company’s product candidates, the FDA or such other regulatory agencies not agreeing with the Company’s regulatory approval strategies, components of the Company’s filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted, the continuing success of the Company’s collaborations, the Company’s ability to obtain additional funding, including through less dilutive sources of capital than equity financings, potential volatility in the Company’s share price, the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and in Israel and the Gaza Strip, 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 the Company’s most recent Annual Report on Form 10-K and the Company’s 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 the Company’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. 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
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