Bridgebio Oncology Therapeutics Inc.

03/05/2026 | Press release | Distributed by Public on 03/05/2026 15:41

Annual Report for Fiscal Year Ending 12-31, 2025 (Form 10-K)

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

This discussion and analysis of our financial condition and results of operations should be read together with the consolidated financial statements and related notes included in this Annual Report on Form 10-K ("Form 10-K"). This discussion may contain forward-looking statements including, but not limited to, our expectations or predictions of future financial or business performance or conditions. Forward-looking statements are inherently subject to risks, uncertainties, and assumptions. You should read the sections in this Form 10-K titled "Risk Factors" and "Special Note of Forward-Looking Statements" for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by these forward-looking statements.

Overview

BBOT is a clinical-stage biopharmaceutical company advancing a next-generation pipeline of novel small-molecule therapeutics targeting RAS and Phosphoinositide 3-kinase ("PI3K"). BBOT is headquartered in South San Francisco, California. Our mission is to accelerate scientific and medical breakthroughs and deliver well-tolerated medicines with greater efficacy and safety to people with the deadliest cancers. We are advancing our next-generation RAS-pathway targeted small molecules with a focus on optimized target coverage for patients with tumors driven by RAS and PI3Kα and a synergistic portfolio that is designed to enable targeted KRAS combinations.

Our business was established in August 2016 by BridgeBio Pharma Inc. ("BridgeBio Pharma"). We operated as part of BridgeBio Pharma through April 30, 2024. Since our inception, we devoted substantially all of our resources to raising capital, conducting discovery and research activities, and establishing arrangements with third parties. We are currently developing three lead product candidates:

BBO-8520 is an orally bioavailable small molecule direct inhibitor targeting both the ON and OFF states of KRAS. OFF-only inhibitors cannot covalently modify the ON-state; hence they need to maintain high concentration levels to capture free cycling KRAS G12C. ON/OFF inhibitors overcome this shortcoming. Dual ON/OFF inhibition allows BBO-8520 to fully capture the covalent mechanism of action, resulting in sustained pathway inhibition even after systemic drug levels decline. We believe this should enable a more potent and safer combination with pembrolizumab in patients with KRAS G12C mutant NSCLC. BBO-8520 has been shown to drive strong anti-tumor activity with favorable durability in multiple preclinical models. Early data from Phase 1 dose escalation showed 60% confirmed overall response rate in KRAS G12C NSCLC patients. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BBO-8520 for the treatment of adult patients with previously treated, KRAS G12C-mutated metastatic NSCLC. We are currently enrolling the Phase 1 ONKORAS-101 trial (NCT06343402) for patients with KRAS G12C mutant non-small cell lung cancer (NSCLC). ONKORAS-101 is an open-label, multi-center Phase 1a/1b study designed to evaluate the safety, tolerability, preliminary antitumor activity, and pharmacokinetics of BBO-8520 as a single agent and in combination with pembrolizumab in patients with KRASG12C mutant NSCLC. Updated clinical data are expected in the first quarter of 2026.
BBO-10203 is an orally bioavailable small molecule with a novel mechanism of action designed to inhibit the physical interaction between RAS and PI3Kα, inhibiting RAS-driven PI3Kα-AKT signaling in tumors. BBO-10203 binds directly and covalently to the RAS-binding domain of PI3Kα, preventing its activation by KRAS, HRAS and NRAS, reducing downstream signaling and tumor growth. It is a protein-protein inhibitor and not a kinase inhibitor, enabling inhibition of RAS-driven PI3Kα-AKT signaling in tumors without the risk of hyperglycemia. Importantly, BBO-10203's ability to block RAS activation of PI3Kα is agnostic to the mutational status of either RAS or PI3Kα. In addition to a potentially differentiated safety profile, BBO-10203 could be combined with direct KRAS inhibitors, such as BBO-8520 and BBO-11818, or drugs that target HER2 or ER receptor. Preclinical data has demonstrated that BBO-10203 blocks RAS-mediated activation of PI3Kα and strongly inhibits pAKT signaling in tumor cells without affecting glucose metabolism. In addition, robust monotherapy activity, as well as combination activity with KRAS inhibitors BBO-8520 and BBO-11818, HER2 inhibitors and ER antagonists, was observed at well-tolerated dose levels. The combination of a KRAS inhibitor with a PI3Kα pathway inhibitor may maximize the response rate and reduce the development of adaptive resistance mechanisms due to full inhibition of both MAPK and PI3Kα signaling. We are currently enrolling the Phase 1 BREAKER-101 trial (NCT06625775) for patients with locally advanced or metastatic HER2+ breast cancer, HR+/HER2-breast cancer, KRAS mutant colorectal cancer, and KRAS mutant non-small cell lung cancer. Initial Phase 1 clinical data are expected in the first half of 2026.
BBO-11818 is an orally bioavailable small molecule pan-KRAS inhibitor that targets mutant KRAS in both the ON and OFF states. Similar to BBO-8520, the structure-based design was employed to target mutant KRAS in both the ON and the OFF states with strong affinity against KRAS G12D and KRAS G12V mutants. BBO-11818 has selectivity over HRAS and NRAS with the goal of achieving high levels of KRAS inhibition in human tumors. In addition, it has combination potential with BBO-10203 to mitigate the PI3Ka resistance pathway. Preclinical data has demonstrated suppression of MAPK signaling and viability in KRAS mutant cell lines, as well as anti-tumor activity across multiple KRAS G12D and KRAS G12V cell-derived xenograft (CDX) models. In addition, BBO-11818's selectivity for KRAS was demonstrated by its >1000-fold lower potency against NRAS, HRAS, and BRAF-mutant cell lines. The preclinical activity of the combination of BBO-11818 with BBO-10203 was driven by a robust decrease in tumor cell proliferation and increase in apoptosis; combination benefit also observed with cetuximab and anti-PD-1 treatment. We are currently enrolling the Phase 1 KONQUER-101 (NCT06917079) trial for patients with locally advanced or metastatic KRAS mutant solid tumors. Initial Phase 1 clinical data are expected in the second half of 2026.

We have no product candidates approved for sale and have not generated any revenue related to our product candidates.

Since inception, we have incurred significant operating losses. For the year ended December 31, 2025, we incurred a net loss of $134.0 million and had an accumulated deficit of $356.6 million as of December 31, 2025. For the year ended December 31, 2024, we incurred a net loss of $74.3 million. Our ability to generate sufficient product revenue to achieve profitability will depend heavily on the development and eventual commercialization of our product candidates. We expect to continue to incur significant expenses, and our operating losses are expected to increase for the foreseeable future if and as we:

Advance our existing and future research and development, including potential expansion into additional indications;
Conduct future clinical studies for our product candidates;
Pursue investigational new drug applications or comparable foreign applications that allow commencement of the planned clinical trials or future clinical trials for any programs we may develop;
Hire research and development, clinical, manufacturing, and commercial personnel;
Add operational, financial, and management information systems and personnel;
Experience any delays, challenges, or other issues associated with the preclinical and clinical development of our product candidates, including with respect to our regulatory strategies;
Develop, maintain, and enhance sustainable, scalable, reproducible, and transferable clinical and commercial-scale cGMP capabilities through a third party or our own manufacturing facility for the product candidates that we may develop;
Seek, obtain, and maintain regulatory approvals for any product candidates for which we successfully complete clinical trials;
Ultimately establish a sales, marketing, and distribution infrastructure to commercialize any product candidates for which we may obtain regulatory approval;
Generate revenue from commercial sales of product candidates for which we receive regulatory approval, if any;
Maintain safety, tolerability, and efficacy profile of any product we may develop in additional indications following approval in one indication;
Maintain, expand, enforce, defend, and protect our intellectual property portfolio and other intellectual property protection or regulatory exclusivity for any products we may develop and defend any intellectual property-related claims;
Further acquire or in-license product candidates or programs, intellectual property, and technologies;
Maintain our current licenses and establish and maintain any future collaborations, including making related development and sales milestone payments, royalties, or other required payments; and
Incur additional costs of operating as a public company, including increased costs of audit, legal, regulatory, and tax-related services associated with maintaining compliance with an exchange listing and the SEC requirements, director and officer insurance premiums and investor and public relations costs.

Any changes in the outcomes of these variables could significantly affect the costs and timing associated with the development of our product candidates. For example, if the U.S. Food and Drug Administration ("FDA") or another comparable regulatory authority were to require us to conduct clinical trials beyond those that we currently anticipate will be required to complete clinical development and obtain regulatory approval of one or more product candidates, or if we experience significant delays in our preclinical studies or

clinical trials, we would be required to expend significant additional financial resources and time to advance and complete clinical development. We may never obtain regulatory approval for any of our product candidates.

We will not generate revenue from product sales unless and until we successfully initiate and complete clinical development and obtain regulatory approval for any product candidates. If we obtain regulatory approval for any of our product candidates and do not enter into a commercialization partnership, we expect to incur significant expenses related to developing our commercialization capability to support product sales, manufacturing, marketing, and distribution.

As a result of the above factors, we expect to need substantial additional funding to support our continued operations and growth strategy. Until such a time as we can generate significant revenue from our product sales, if ever, we expect to finance our operations through the sale of equity, debt financings, or other capital sources, including collaborations with other companies or other strategic transactions. We may not be able to raise additional funds or enter into such other agreements on favorable terms or at all. If we fail to raise capital or enter into such agreements as and when needed, we may have to significantly delay, scale back, or discontinue the development and commercialization of one or more of our programs.

Due to the numerous risks associated with product development, we cannot accurately predict the timing or amount of increased expenses, or when or if we will be able to achieve or maintain profitability. Even if we are able to generate product sales, we may not become profitable. If we fail to become profitable or cannot sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.

de-SPAC Transaction

On February 28, 2025, TheRas, Inc. ("Legacy BBOT") entered into a definitive business combination agreement, amended on June 17, 2025 ("Business Combination Agreement") with Helix Acquisition Corp. II ("Helix"), a publicly traded special purpose acquisition company listed on Nasdaq under the ticker symbol "HLXB." Pursuant to the Business Combination Agreement closing, Helix II Merger Sub, Inc., a wholly owned subsidiary of Helix, merged with and into Legacy BBOT, with Legacy BBOT surviving the merger as a wholly-owned subsidiary of Helix ("Merger"). In connection with the Merger, Helix changed its name to BridgeBio Oncology Therapeutics, Inc. and redomiciled as a Delaware corporation ("de-SPAC Transaction"). The de-SPAC Transaction was consummated on August 11, 2025 ("Closing"), and BBOT's common stock became listed on Nasdaq under the ticker symbol "BBOT". Prior to the Closing, all references to BBOT are related to the balances and activity of Legacy BBOT. Upon the Closing, BBOT became the successor of Helix and the reporting entity, which consolidates the balances and activity of Legacy BBOT.

Concurrent with the execution of the Business Combination Agreement, Helix entered into subscription agreements with certain investors pursuant to which Helix agreed to issue and sell shares of its common stock to investors in a private placement financing ("PIPE Financing") for an aggregate purchase price of approximately $260.9 million, which was executed immediately prior to the Closing.

The de-SPAC Transaction was accounted for as a reverse recapitalization effective upon the Closing. Under this method of accounting, Helix was treated as the acquired company for accounting purposes, and BBOT was the deemed acquirer for accounting purposes. The consolidated financial statements of BBOT for periods prior to the Closing include the financial information of Legacy BBOT.

The number of shares and per share amounts for all periods presented were adjusted to reflect the capital structure of BBOT. For periods prior to the Closing, the share activity of BBOT was recast by multiplying the number of shares of Legacy BBOT held by each investor by a ratio of approximately 0.0889 ("Consideration Ratio"), established by the Business Combination Agreement, rounded down to the nearest whole share. The de-SPAC Transaction is presented as the issuance of common stock for the net assets of Helix and proceeds from the PIPE Financing, accompanied by a recapitalization and a change in the reporting entity. The net assets of Helix were recorded at historical cost as of the Closing date, with no goodwill or other intangible assets recognized.

As a result of the de-SPAC Transaction, we assumed the operations of Legacy BBOT upon the Closing, and we became subject to the regulatory and reporting requirements and customary practices applicable to public companies. The costs and administrative demands of operating as a public company, including hiring additional personnel and implementing certain procedures and processes, may materially impact our financial position and results of operations.

Material Related Party Transactions

BridgeBio Pharma 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 Pharma and its controlled entities are related parties of BBOT.

In August 2025, upon completion of the de-SPAC Transaction, we made a contractual promise to issue 784,720 shares of our common stock to BridgeBio Pharma ("TSA Shares"), which was not contingent on anything but the passage of time. We treated this transaction as a nonreciprocal transfer with a non-pro-rata distribution to related party. The contract was concluded to be equity-classified, and we recorded general and administrative expense of $7.8 million equal to the fair value of the underlying shares as of the contract execution date. The TSA Shares were issued to BridgeBio Pharma in October 2025.

Emerging Growth Company Status

As an emerging growth company ("EGC") under the Jumpstart Our Business Startups Act (the "JOBS Act"), we are eligible for certain regulatory relief, including reduced disclosure obligations and extended transition periods for adopting new or revised accounting standards. Our EGC status commenced upon the completion of Helix's initial public offering in February 2024 and is expected to continue for up to five years from this date through February 2029, unless certain disqualifying events occur earlier, such as achieving large accelerated filer status.

Impact of General Economic Risk Factors on Our Operations

Uncertainty in the global economy presents significant risks to our business. We are subject to continuing risks and uncertainties in connection with the current macroeconomic environment, including inflation, fluctuating interest rates, new or increased tariffs and other barriers to trade, changes to fiscal and monetary policy or government budget dynamics, particularly in the pharmaceutical and biotech spaces, bank failures, geopolitical factors, including the ongoing conflicts between Russia and Ukraine and in the Middle East and the responses thereto, and supply chain disruptions.

While we closely monitor the impact of the current macroeconomic and geopolitical conditions on all aspects of our business, including the impacts on participants in any future clinical trials and our employees, suppliers, vendors, business partners, and our future access to capital, the ultimate extent of the impact on our business remains highly uncertain and will depend on future developments and factors that continue to evolve. Most of these developments and factors are outside of our control and could exist for an extended period. We will continue to evaluate the nature and extent of the potential impacts on our business, results of operations, liquidity, and capital resources.

Basis of Presentation and Principles of Consolidation

The consolidated financial statements of BBOT for the year ended December 31, 2025, included in Item 8 of this Form 10-K, are prepared in accordance with generally accepted accounting principles in the United States ("US GAAP"). All costs, assets, and liabilities directly associated with BBOT's business activity are included in our consolidated financial statements. In connection with the de-SPAC Transaction, as the successor entity following the Closing, BBOT became the reporting entity and consolidates the balances and activity of Legacy BBOT. The financial information presented in these consolidated financial statements reflects the balances and results of operations of the combined entity post-Merger. Prior to the Closing, all references to BBOT or the Company are related to the balances and activity of Legacy BBOT. All intercompany balances have been eliminated in consolidation.

From its inception through the issuance of the Series B redeemable convertible preferred stock ("Series B") on April 30, 2024 ("Legacy BBOT Series B Financing"), Legacy BBOT had been majority-owned and controlled by BridgeBio Pharma. Prior to April 30, 2024, we operated as part of BridgeBio Pharma and not as an independent entity. The consolidated financial statements of BBOT have been derived from BridgeBio Pharma's historical accounting records and are presented on a carve-out basis. Before April 30, 2024, the consolidated financial statements include allocations of certain general and administrative expenses to Legacy BBOT from BridgeBio Pharma. The allocations have been determined on a reasonable basis; however, the amounts are not necessarily representative of the amounts that would have been reflected in the consolidated financial statements had BBOT been an entity that operated independently from BridgeBio Pharma. After April 30, 2024 and prior to the de-SPAC Transaction, the financial information in the consolidated financial statements relates to Legacy BBOT operating on a standalone basis.

Components of Results of Operations

Revenues

To date, we have not generated any revenue from product candidates under development and does not expect to generate any revenue in the foreseeable future. If our development efforts for our product candidates are successful and result in regulatory approval, we may generate revenue from product sales in the future. We cannot predict if, when, or to what extent we will generate revenue from the commercialization and sale of our product candidates. We may never succeed in obtaining regulatory approval for any of our product candidates.

Operating Expenses

Research and Development Expenses

Research and development expenses consist primarily of costs incurred for our research activities, including our drug discovery efforts, and the development of our product candidates, which include:

Employee-related expenses, including salaries, related benefits, stock-based compensation, and travel expenses for employees engaged in research and development functions;
Expenses incurred in connection with the preclinical and clinical development of our product candidates, including under agreements with contract research organizations ("CROs");
The cost of consultants and contract manufacturing organizations ("CMOs") that manufacture drug products for use in our preclinical studies and clinical trials;
Facilities, depreciation, insurance, and other direct and allocated expenses incurred as a result of research and development activities; and
Payments made under third-party licensing and asset acquisition agreements.

We expense research and development costs as incurred. Non-refundable advance payments that we make for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed.

Our direct research and development costs consist primarily of external costs, such as fees paid to consultants, contractors, CMOs, and CROs in connection with our preclinical and clinical development activities.

We are heavily dependent on the success of our product candidates, which are in early stages of development, and require a lengthy and expensive process with uncertain outcomes and the potential for substantial delays. We cannot give any assurance that any of our product candidates will receive regulatory approval, which is necessary before they can be commercialized.

Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages, primarily due to the increased size and duration of later-stage clinical trials. We expect that our research and development expenses will increase substantially in connection with our planned clinical and preclinical development activities in the near term and in future reporting periods, as we conduct additional clinical trials for our product candidates. We currently track research and development expenses based on expense nature.

General and Administrative Expenses

Our general and administrative costs consist primarily of fair value of common stock issued to BridgeBio Pharma, employee-related costs, travel expenses, expenses for outside professional services, including legal, human resources, audit, accounting, and tax services, and allocated facilities-related costs. Employee-related costs include salaries, bonuses, related benefits, and stock-based compensation.

We expect to incur additional expenses as a result of operating as a public company, including expenses related to compliance with the rules and regulations of the SEC and listing standards applicable to companies listed on a national securities exchange, additional insurance expenses, investor relations activities, and other administrative and professional services. We also expect to increase the size of our administrative, finance, and legal functions to support the anticipated growth of our business.

Other Income (Expenses), Net

Interest Income

Other income consists of interest income earned on our cash equivalents and marketable securities.

Income Under Transition Services Agreement

In 2024, other income included income for services provided to BridgeBio Pharma subsequent to the Legacy BBOT Series B Financing under the transition services agreement with BridgeBio Pharma. In 2025, other income includes income for services provided to another party under a different transition services agreement.

Change in Fair Value of Participation Right Liability

Change in fair value of participation right liability represents the income or expense from the right to participate in the Legacy BBOT Series B Financing that we provided to the Regents of the University of California ("UCSF"), which was determined to be a freestanding financial instrument. This right was not exercised upon the initial issuance of the Series B in April 2024 and was subsequently extended through March 2025. UCSF elected to exercise the participation right in March 2025, and it was settled in full through the issuance of Series B shares in April 2025.

Results ofOperations

Comparison of the years ended December 31, 2025 and 2024

The following table sets forth a summary of our results of operations for the years ended December 31, 2025 and 2024 (in thousands):

Year Ended December 31,

2025

2024

Change

Change, %

Operating expenses:

Research and development

121,199

73,107

48,092

66

%

General and administrative

24,620

7,756

16,864

217

%

Total operating expenses

145,819

80,863

64,956

80

%

Loss from operations

(145,819

)

(80,863

)

(64,956

)

80

%

Other income (expense), net:

Interest income

11,343

6,377

4,966

78

%

Income from transition services agreements

1,192

775

417

54

%

Change in fair value of participation right liability

(725

)

(564

)

(161

)

29

%

Other income (expense)

(35

)

-

(35

)

100

%

Total other income (expense), net

11,775

6,588

5,187

79

%

Net loss

$

(134,044

)

$

(74,275

)

$

(59,769

)

81

%

Research and Development Expenses

Research and development expenses consisted of the following components for the periods indicated (in thousands):

Year Ended December 31,

2025

2024

Change

Research and development trials and consumables expenses

$

84,578

$

36,680

$

47,898

Payroll and personnel expenses

26,616

24,077

2,539

Facilities and other expenses

10,005

12,350

(2,345

)

Total research and development

$

121,199

$

73,107

$

48,092

Research and development expenses increased by $48.1 million or 66%, from $73.1 million for the year ended December 31, 2024, to $121.2 million for the year ended December 31, 2025. The changes in research and development expenses include the following key drivers:

a $47.9 million increase primarily due to increase in clinical trial expenses and manufacturing expenses for BBO-8520, BBO-10203 and BBO-11818,
a $2.5 million increase in our payroll and personnel expenses primarily due to headcount expansion, and
a $2.3 million decrease primarily from reduced professional fees and consulting costs from related parties attributable to the winding down of activities under the transition services agreement with BridgeBio Pharma.

General and Administrative Expenses

General and administrative expenses increased by $16.9 million or by 217%, from $7.8 million for the year ended December 31, 2024, to $24.6 million for the year ended December 31, 2025. The change was primarily driven by the following key drivers:

a $8.8 million increase related to personnel-related expenses and professional and consulting fees, which reflects the initiation of our standalone operations and the de-SPAC Transaction, and
a $7.8 million charge related to TSA Shares issued to BridgeBio Pharma.

Interest Income

Interest income increased by $5.0 million, from $6.4 million for the year ended December 31, 2024, to $11.3 million for the year ended December 31, 2025. This increase was primarily driven by a full year of interest earnings on our marketable securities portfolio and interest earned on the proceeds from the de-SPAC Transaction and PIPE Financing completed in August 2025.

Income from Transition Services Agreements

Other income of $0.8 million for the year ended December 31, 2024 was related to the transition services agreement with BridgeBio Pharma executed after the Legacy BBOT Series B Financing. Other income of $1.2 million for the year ended December 31, 2025 was recognized in connection with a transition services agreement with a third party.

Change in Fair Value of Participation Right Liability

The changes in fair value of participation right liability of $0.7 million for the year ended December 31, 2025 and $0.6 million for the year ended December 31, 2024 were driven primarily by the increase in the estimated fair value per share of the underlying Legacy BBOT Series B redeemable convertible preferred stock relative to the fixed price per share granted to UCSF in connection with the participation right. The participation right was settled in full in April 2025, and there were no subsequent changes in fair value of the associated liability.

Liquidity, Going Concern, and Capital Resources

Sourcesof Liquidity

Since our inception, BBOT has incurred significant operating losses. For the year ended December 31, 2025, BBOT incurred a net loss of $134.0 million and had an accumulated deficit of $356.6 million as of December 31, 2025. For the year ended December 31, 2024, BBOT incurred a net loss of $74.3 million.

In January 2017, we issued to BridgeBio Pharma 800,061 shares of Series Seed redeemable convertible preferred stock in a single closing at $1.2508 per share for gross cash proceeds of $1.0 million. Between May 2017 and April 2024, we issued to BridgeBio Pharma 10,929,005 shares of Series A redeemable convertible preferred stock ("Series A") at $11.2467 per share for gross cash proceeds of $122.9 million and 2,072,629 shares of the Series A at $11.2467 per share in exchange for the settlement of related party payables of $23.3 million. In April 2024, BBOT received $175.0 million in gross cash proceeds from the issuance of 19,761,881 shares of Series B at $8.8554 per share. In May 2024, BBOT received $25.0 million in gross cash proceeds through the issuance of 2,823,126 shares of Series B at $8.8554 per share. In March 2025, UCSF elected to exercise the Participation Right. BBOT settled the Participation Right in April 2025 through the issuance of 2,509,446 shares of the Series B for $22.2 million of cash proceeds.

In August 2025, upon closing of the de-SPAC Transaction, the combined company received $373.5 million from Helix, which included the proceeds from the PIPE Financing, the unredeemed cash held by Helix, and reflected payment of Helix's transaction costs. The proceeds from the PIPE Financing and reverse recapitalization are expected to advance our project pipeline and will be used for research and development, business development, working capital, and other general corporate purposes.

We estimate that the existing cash, cash equivalents, and marketable securities of BBOT of $425.5 million as of December 31, 2025 will be sufficient to meet our cash requirements for at least twelve months from the issuance date of the consolidated financial statements for the year ended December 31, 2025 included in this Form 10-K. We have based this estimate on assumptions that may prove to be wrong, and our operating plan may change due to many factors currently unknown to management. We could exhaust our available capital resources sooner than management expects.

In the future, we plan to access capital resources by public or private equity offerings, debt financings, potential collaborations, licensing agreements, and other sources. We have historically been able to raise capital through the issuance and sale of equity and equity-linked instruments, such as redeemable convertible preferred stock for Legacy BBOT and common stock for BBOT. However, no assurance can be provided that we will continue to be successful in doing so in the future. If sufficient funds on acceptable terms are not available when needed, we may be required to significantly reduce our operating expenses and delay, reduce the scope of, or eliminate one or more of our development programs. Failure to manage discretionary spending or raise additional financing, as needed, may adversely impact our ability to achieve our intended business objectives.

Cash Flows

Overview of BBOT Cash Flows

We have historically financed our operations primarily through the sale of equity securities. During the year ended December 31, 2024, we raised capital through our Series A financing from BridgeBio Pharma and the initial closing of the Legacy BBOT Series B Financing to external investors. During the year ended December 31, 2025, we received additional proceeds from the Legacy BBOT Series B financing. The de-SPAC Transaction completed in August 2025 represented a significant financing event, generating cash inflows from the reverse recapitalization and the associated PIPE Financing. We utilized the proceeds from these financing transactions to fund our operating activities during the years ended December 31, 2025 and 2024. We expect to continue using these available funds to facilitate the ongoing development of our product candidates. Subsequent to April 30, 2024, we began operating as a standalone entity and deployed available funds from the Legacy BBOT Series B Financing into marketable securities. The proceeds from the de-SPAC Transaction are currently held in cash equivalents and did not contribute materially to cash flows from investing activities for the year ended December 31, 2025.

The changes in our working capital structure and operating cash flows were notably impacted by the timing of cash disbursements related to our research and development activities. Specifically, we made significant prepayments under our agreements with contract research organizations and contract manufacturing organizations prior to the commencement of clinical trials and manufacturing activities. These upfront deposits increase our prepaid expenses and non-current assets and accelerate cash outflows in periods prior to the recognition of the associated research and development expenses, causing period-over-period fluctuations in our operating cash burn, especially as we ramp up the development of our product candidates.

Material Adjustmentsfor Non-Cash Investing and Financing Activities

During the year ended December 31, 2025, we recognized $3.8 million in settlement of participation right liability upon the issuance of the Series B redeemable convertible preferred stock, which resulted in a reclassification of the settlement date fair value of this liability to temporary equity. Additionally, we recognized a $2.7 million right-of-use asset obtained in exchange for operating lease liability upon commencement of our office lease space in March 2025.

During the year ended December 31, 2024, we extinguished related party payables of $19.7 million due to the conversion of these liabilities into Series A redeemable convertible preferred stock issued to BridgeBio Pharma. We also recorded $2.5 million to reflect the initial fair value of the participation right liability, which was allocated from the proceeds of the Legacy BBOT Series B Financing. Additionally, at the time of the Legacy BBOT Series B Financing, we recognized $3.7 million from the forgiveness of our related party payables to BridgeBio Pharma as a deemed contribution credited to additional paid-in capital.

Cash Flow Comparison for the years ended December 31, 2025 and 2024

The following table summarizes our cash flows during the periods indicated (in thousands):

Year Ended December 31,

2025

2024

Change

Net cash used in operating activities

$

(113,894

)

$

(55,027

)

$

(58,867

)

Net cash provided by (used in) investing activities

73,328

(120,530

)

193,858

Net cash provided by financing activities

383,402

206,290

177,112

Net increase in cash, cash equivalents, and restricted cash

$

342,836

$

30,733

$

312,103

Net Cash Flows fromOperating Activities

Net cash used in our operating activities for the year ended December 31, 2025 was $113.9 million. This amount consisted of our net loss of $134.0 million, reduced to reflect net changes in operating assets and liabilities of $6.4 million, and further reduced by non-cash charges of $13.7 million. Our non-cash adjustments primarily consisted of $7.8 million charge representing the fair value of shares issued to BridgeBio Pharma, $5.9 million in stock-based compensation, $0.7 million for losses from changes in the fair value of the

participation right liability prior to its settlement, $0.3 million in depreciation of property and equipment, and $0.3 million in amortization of right-of-use assets, partially offset by $1.3 million in net accretion of premiums on marketable securities. The net change in operating assets and liabilities was primarily due to an increase in our liabilities, including $17.7 million increase in accrued research and development liabilities, and $1.9 million increase in accrued compensation and benefits. These changes were partially offset by a decrease of $7.6 million in other non-current assets, a decrease of $3.4 million in prepaid expenses, and a decrease of $1.8 million in accounts payable.

Net cash used in operating activities for the year ended December 31, 2024 was $55.0 million. This amount consisted of our net loss of $74.3 million, reduced to reflect changes in operating assets and liabilities of $15.6 million, and further reduced to reflect our non-cash charges of $3.7 million. Our non-cash adjustments primarily included $4.4 million in stock-based compensation, $0.6 million in the fair value of the participation right liability, and $0.2 million in depreciation of property and equipment, partially offset by $1.5 million in net accretion of premiums on marketable securities. The net change in operating assets and liabilities was primarily due to an increase in our liabilities, including $9.4 million from the net related party balances, $4.9 million increase in accrued research and development liabilities, $2.7 million increase in accrued compensation and benefits, a $2.5 million increase in accounts payable, and a $0.5 million increase in accrued professional services. These changes were partially offset by an increase of $3.6 million in other non-current assets and $1.0 million in prepaid expenses.

Net Cash Flows from Investing Activities

Net cash provided by investing activities for the year ended December 31, 2025 was $73.3 million, which consisted of $157.9 million in cash inflows from maturities of marketable securities, offset by $83.9 million in cash outflows from purchases of marketable securities, and $0.6 million in purchases of property and equipment.

Net cash used in investing activities for the year ended December 31, 2024, was $120.5 million, which consisted of $154.4 million in cash outflows from purchases of marketable securities offset by $31.5 million in cash inflows from maturities of marketable securities, and $2.4 million in cash inflows related to a cash pooling arrangement with BridgeBio Pharma.

Net Cash Flows from Financing Activities

Net cash provided by financing activities of $383.4 million for the year ended December 31, 2025 included $373.5 million in proceeds from the reverse recapitalization and PIPE Financing and $22.2 million cash inflows from the issuance of Series B shares to UCSF, offset by $12.3 million cash outflow related to the payment of de-SPAC Transaction costs.

Net cash provided by financing activities of $206.3 million for the year ended December 31, 2024 included primarily the net proceeds from the Legacy BBOT Series B Financing from new investors of $199.3 million, the net proceeds from the Series A financing from BridgeBio Pharma of $5.9 million, and $1.1 million for constructive cash inflows related to other contributions from BridgeBio Pharma.

Future FundingRequirements

We will not generate revenue from product sales unless we complete clinical development and obtain regulatory approval for our product candidates. If we obtain regulatory approval for any of our product candidates and do not enter into a commercialization partnership, we expect to incur significant expenses related to developing our internal commercialization capability to support product sales, marketing, and distribution.

Subsequent to the de-SPAC Transaction, we expect to incur additional costs associated with operating as a public company. In the future, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of equity offerings, debt financings, collaborations, strategic alliances, and marketing, distribution, or licensing arrangements. If we do raise additional capital through public or private equity offerings, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders' rights. If we raise additional capital through debt financing, we may be subject to covenants that limit or restrict our ability to take specific actions, such as incurring debt, making capital expenditures, or declaring dividends. Furthermore, we may be unable to raise additional funds or enter into other agreements or arrangements on favorable terms or at all when needed. If we fail to raise capital or enter into such agreements, as and when needed, we may have to significantly delay, scale back, or discontinue the development and commercialization of one or more of our product candidates.

Due to the numerous risks and uncertainties associated with the research, development, and commercialization of pharmaceutical products, we are unable to accurately estimate the exact amount of our operating capital requirements. Our future funding requirements will depend on many factors, including, but not limited to:

The successful achievement of preclinical and clinical milestones;
Continuing our research and drug discovery and development efforts;
Conducting preclinical and clinical trials for our current product candidates and additional product candidates;
Establishing a sales, marketing, and distribution infrastructure to commercialize any product candidates for which we may obtain regulatory approval;
Establishing and maintaining manufacturing and supply chain capacity sufficient to provide adequate supplies of our product candidates to support our ongoing and planned clinical trials and commercial quantities of any product candidates for which we may obtain marketing approval;
Maintaining, expanding, and protecting our intellectual property portfolio;
Acquiring or in-licensing other product candidates and technologies;
Continuing to discover and develop additional product candidates;
Hiring additional personnel to support our product candidate development efforts to obtain regulatory approval and securing additional facilities for operations; and
Operating as a public company following the de-SPAC Transaction.

Due to the numerous risks and uncertainties associated with the development of our product candidates, we are unable to accurately predict the timing or amount of increased expenses, or when or if we will be able to achieve or maintain profitability. Even if we are able to generate product sales, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at the planned levels and be forced to reduce or terminate our operations.

In-Licensing and Collaboration Agreements

The Regents of the Universityof California License Agreements

In September 2016, BBOT entered into a license agreement with UCSF and was granted certain worldwide exclusive licenses to use the licensed compounds (the "UCSF License"). The UCSF License was subsequently amended and was terminated in June 2021.

Under the UCSF License, UCSF received the right, but not the obligation, to purchase up to 10% of the securities in any offering on the same terms as other investors, which survived the termination of the UCSF License ("Participation Right"). Because UCSF was not notified of the Legacy BBOT Series B Financing at the time it was completed in 2024, the Participation Right was extended through March 29, 2025. As a result, UCSF received the right to purchase up to 2,509,446 shares of Series B at the original issue price of $8.8554 per share. In April 2025, we settled the Participation Right in full by issuing of 2,509,446 Series B shares for cash proceeds of $22.2 million, and it was no longer outstanding as of December 31, 2025.

Leidos Biomedical Research License and Cooperative Research and Development Agreements

In March 2017, BBOT entered into a cooperative research and development agreement ("Leidos CRADA") with Leidos Biomedical Research, Inc. ("Leidos"). In December 2018, BBOT and Leidos entered into a license agreement ("Initial Leidos License"), under which BBOT was granted certain worldwide exclusive licenses to use the licensed compounds related to its drug discovery and development initiatives. The Initial Leidos License was terminated in 2021. BBOT and Leidos subsequently entered into three additional license agreements ("Additional Leidos Licenses"), including two related to KRAS G12C inhibitor and P13Ka breaker compounds that were executed in August 2022, and one related to the PanKRAS inhibitor executed in December 2023. The Leidos CRADA, the Initial Leidos License, and the Additional Leidos Licenses are referred to as the "Leidos Agreements." In December 2025, BBOT and Leidos executed an amendment to extend the expiration date of the Leidos CRADA by nine months to September 2026. In December 2025, the Company and Leidos amended the Leidos Agreements to introduce an additional $1.5 million in contingent development milestone payments.

Under the Additional Leidos Licenses, BBOT incurred initial upfront fees of $1.8 million and BBOT is required to pay Leidos certain annual license maintenance fees and royalties on net sales for such licensed compounds. As of December 31, 2025, BBOT was obligated to make contingent milestone payments totaling up to $25.9 million upon the achievement of certain clinical and regulatory milestones. As of December 31, 2025, BBOT recorded a $0.5 million liability for milestones that had been achieved but remained unpaid, which is included in the accrued research and development liabilities in the consolidated balance sheet. In connection with our arrangements with Leidos, we recognized research and development expenses of $3.0 million and $3.6 million for the years ended December 31, 2025 and 2024, respectively.

Lawrence Livermore National Security License and Cooperative Research and Development Agreements

In May 2018, BBOT entered into a cooperative research and development agreement ("LLNS CRADA") with Lawrence Livermore National Security, LLC ("LLNS") to bring new knowledge and therapeutic possibilities to KRAS drug discovery utilizing LLNS' high-performance computing machines. BBOT and LLNS executed five subsequent amendments to the LLNS CRADA between December 2019 and November 2025 to clarify the scope and provide for term extensions. In July 2022, BBOT entered into an exclusive patent license agreement for KRAS G12C inhibitors and an exclusive patent license agreement for PI3Kα breaker compounds. In December 2024, BBOT entered into an exclusive license agreement with LLNS for research and development of Pan KRAS inhibitor for oncology indications. In July 2025, BBOT entered into an exclusive license agreement with LLNS for research and development of Pan KRAS inhibitor for non-oncology indications. These four agreements are collectively referred to as the LLNS Agreements. In November 2025, BBOT and LLNS executed three separate amendments to the existing agreements for Pan KRAS inhibitors, PI3Kα breakers, and KRAS G12C inhibitors. These amendments were made to include new patent applications within the scope of patent rights. In November 2025, BBOT and LLNS executed an amendment to extend the LLNS CRADA expiration date by six months to June 2026.

Upon execution of the LLNS Agreements, BBOT paid an initial upfront cash fee of $0.2 million. In addition, under the terms of the LLNS Agreements, BBOT is required to pay LLNS certain annual license maintenance fees and royalties to LLNS on net sales for such licensed compounds. As of December 31, 2025, BBOT is required to make contingent milestone payments totaling up to $21.1 million upon the achievement of certain clinical, regulatory, and sales milestones. In connection with our arrangements with LLNS, we recognized research and development expenses of $0.8 million and $2.1 million for the years ended December 31, 2025 and 2024, respectively.

As of December 31, 2025, we did not have any off-balance sheet arrangements that have a material current effect or that are reasonably likely to have a material future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures, or capital resources.

Critical Accounting Policies and Estimates

Our management's discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with US GAAP. The preparation of consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, and the disclosure of contingent assets and liabilities as of the date of the consolidated financial statements, as well as the expenses incurred during the reporting periods. Our estimates are based on our historical experience and various other factors that we believe are reasonable under the circumstances, which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

Our significant accounting policies are described in more detail in Note 2 to BBOT's consolidated financial statements included in this Form 10-K. We believe that the following accounting policies and estimates are most critical to the judgments and used in the preparation of the consolidated financial statements.

Accrued Research and Development Liabilities

We record accruals for estimated costs of research and development activities performed by third-party service providers, including preclinical studies, clinical trials, and contract manufacturing. We record the estimated costs of research and development activities based on the estimated amount of services provided but not yet invoiced and include these costs in accrued research and development liabilities in the consolidated balance sheets and within research and development expenses in the consolidated statements of operations and comprehensive income. These costs are a significant component of our research and development expenses. Examples of estimated research and development expenses that we accrue include:

Fees paid to CROs in connection with preclinical and toxicology studies and clinical trials;
Fees paid to investigative sites in connection with clinical trials;
Fees paid to contract manufacturing organizations in connection with the production of product and clinical trial materials; and
Professional service fees for consulting and related services.

We base our expense accruals for clinical trials on estimates of services received and efforts expended under contracts with multiple research institutions and CROs that conduct and manage clinical trials on our behalf. The financial terms of these agreements vary from contract to contract and may result in uneven payment flows. Payments under some of these contracts depend on factors such as patient enrollment and the completion of clinical trial milestones. Our service providers generally invoice us monthly in arrears for services performed. In accruing service fees, we estimate the period over which services will be performed and the level of effort to be expended

in each period. If we do not identify costs we have already incurred, or if we underestimate or overestimate the level of services performed or the costs of those services, our actual expenses could differ from our estimates. We record advance payments to service providers as prepaid assets.

We record accruals for the estimated costs of third-party contract manufacturing activities. The financial terms of these agreements are negotiable, vary from contract to contract, and may result in uneven payment flows to our vendors. Payments under the contracts include upfront payments and milestone payments, which depend on factors such as the completion of certain stages of the manufacturing process. To recognize an expense, we assess whether the production process is sufficiently defined to be the delivery of a good or a service, given that processes and yields are developing and less certain. If we consider the process to be the delivery of a good, we recognize the expense when the drug product is delivered, or we otherwise bear the risk of loss. If we consider the process to be the delivery of a service, we recognize expenses based on our best estimates of the contract manufacturer's progress through the contract stages. We base our estimates on the best information available at the time. However, additional information may become available to us, enabling us to make a more accurate estimate in future reporting periods. In this event, we may be required to record adjustments to research and development expenses in future reporting periods when the actual level of activity becomes more certain. Any increases or decreases in cost are generally considered to be changes in estimates and will be reflected in research and development expenses in the reporting period identified.

Allocated Operating Expenses and Related Party Transactions

Our operating expenses include significant amounts charged by or related to transactions with BridgeBio Pharma.

Prior to April 30, 2024, BBOT operated as part of BridgeBio Pharma. Costs and expenses directly attributable to BBOT's operations were recorded in the BBOT's ledger with a corresponding liability, based on their nature. BBOT also utilized certain general and administrative functions of BridgeBio Pharma that were not recorded in its ledger. These general and administrative expenses represent the costs of doing business that would have been incurred if BBOT were to operate on a standalone basis. These general and administrative expenses were recorded in these consolidated financial statements using the carve-out operating expense allocation methodology. The allocation process used a percentage of the operating expenses incurred by BBOT in each period compared to the total operating expenses incurred by all BridgeBio Pharma entities. This percentage was then applied to the applicable general and administrative expenses incurred by BridgeBio Pharma to calculate the amounts attributable to our operations.

We consider the allocation methodology used to be reasonable and to appropriately reflect the related expenses attributable to BBOT based on its activity in each period and for the purposes of consolidated financial statements for the year ended December 31, 2024. However, the allocated expenses reflected in consolidated financial statements for the year ended December 31, 2024, may not be indicative of the actual expenses that would have been incurred during the periods presented if BBOT had operated as a separate standalone entity. Additionally, the allocated expenses may not accurately reflect the expenses BBOT will incur in the future.

If we were not required to reimburse BridgeBio Pharma for the operating expenses, such amounts were presented as a deemed contribution from BridgeBio Pharma to BBOT and credited to stockholders' equity (deficit). If BBOT was required to reimburse BridgeBio Pharma for the operating expenses, such amounts were credited to liability. Subsequent to the Legacy BBOT Series B Financing, all outstanding amounts under the transition services agreement with BridgeBio Pharma are presented as assets and liabilities.

During the year ended December 31, 2025, BBOT recognized $0.8 million in research and development expenses and $8.4 million in general and administrative expenses for the services provided by BridgeBio Pharma under the transition services agreement. General and administrative expenses for the year ended December 31, 2025 include the grant date fair value of the TSA Shares issued to BridgeBio Pharma of $7.8 million discussed in section "-Material Related Party Transactions" above.

During the year ended December 31, 2024, BBOT recognized $8.9 million in research and development expenses and $2.8 million in general and administrative expenses for the services provided by BridgeBio Pharma. For the year ended December 31, 2024, the allocated general and administrative expenses calculated using the carve-out methodology included $1.1 million for other administrative expenses and $0.9 million for stock-based compensation.

During the year ended December 31, 2024, BBOT recognized $0.8 million in income from services rendered to BridgeBio Pharma under the transition services agreement executed after the Legacy BBOT Series B financing to facilitate BBOT's transition to standalone operations. No such related party income from transition services agreements was recognized during the year ended December 31, 2025.

Stock-based Compensation

Stock-based compensation is recorded in research and development expenses or general and administrative expenses based on the grantee's function. Prior to April 30, 2024, stock-based compensation recorded included the following components:

Amounts related to equity and liability-classified awards issued by BridgeBio Pharma to non-employees of BBOT engaged in its research and development activities. These amounts were initially credited to liability and subsequently settled by BBOT through the issuance of Series A redeemable convertible preferred stock.
Amounts related to stock-based awards issued by BridgeBio Pharma and allocated to BBOT based on the carve-out expense allocation methodology. These amounts were not expected or required to be settled in cash and were credited to stockholders' equity (deficit), within additional paid-in capital.

Subsequent to April 30, 2024, stock-based compensation includes expenses related to common stock options granted by BBOT. The associated stock-based compensation is generally recognized on a straight-line basis over the requisite service period, which is generally the vesting period. Forfeitures of share-based awards are accounted for as they occur. The fair value of stock options is estimated on the grant date using the Black-Scholes option-pricing model, which requires certain assumptions further discussed below:

Fair Value of Common Stock: Prior to the de-SPAC Transaction, the fair value of our common stock was determined by the board of directors with input from management and consideration of third-party valuation reports. In the absence of a public trading market, and as a clinical-stage company with no significant revenues, BBOT has concluded that it was appropriate to consider a range of factors to determine the fair market value of the common stock at each grant date. In addition, BBOT considered various objective and subjective factors, along with input from the independent third-party valuation firm. The factors included (1) the achievement of the development milestones by BBOT; (2) the significant risks associated with BBOT's stage of development; (3) capital market conditions for comparable, privately held, early-stage life science companies; (4) BBOT's available liquidity, financial condition, and results of operations; (5) the sales of BBOT's shares to third parties, such as the Legacy BBOT Series B Financing; and (6) the preferential rights of the redeemable convertible preferred stockholders. Following the de-SPAC Transaction, we became a public company and derive the fair value of our common stock from quoted prices on the Nasdaq.
Expected Dividend Yield: BBOT has historically paid no dividends and does not anticipate paying dividends in the future.
Expected Equity Volatility: BBOT does not have sufficient trading history for its common stock and has computed expected volatility based on the historical volatility of a representative group of public companies with similar characteristics to BBOT (e.g., public entities of similar size, complexity, stage of development, and industry focus). The historical volatility is commensurate with the expected term assumption.
Risk-Free Interest Rate: The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of award grant for the expected term of the award.
Expected Term: BBOT uses the simplified method to calculate the expected term for options granted to employees, as it does not have sufficient historical exercise data to provide a reasonable basis for estimating the expected term.

ParticipationRight Liability

The participation right liability represented the right granted to USCF to potentially participate in future Series B offerings at a fixed price of $8.8554 per share. The participation right was a freestanding instrument substantially similar to a written call option on the Series B shares that may be redeemed outside of the Company's control. As such, the Company classified the participation right as a liability, remeasured at fair value, until the participation right was exercised. Changes in the fair value of the participation right liability are presented separately in the consolidated statements of operations. The participation right liability was subsequently settled in full in April 2025 as part of the issuance of the Series B shares, and its fair value represented the estimated intrinsic value per Series B share as of the settlement date.

As of the settlement date in April 2025, the fair value of the participation right liability was determined based on the intrinsic value of the underlying option to purchase each share of the Series B. The fair value per Series B share was estimated using the Probability-Weighted Expected Return Method ("PWERM"). Under the PWERM, we considered various liquidity events, including the de-SPAC Transaction, an initial public offering, and a sale of BBOT, assigned probability to each liquidity scenario, and estimated the fair value per Series B share using the following assumptions:

Probability of a Qualifying Liquidity Event: This refers to the likelihood that a qualifying liquidity event will occur during the expected term of the liability.
Expected Term, Years: This represents the estimated timeframe in years until a qualifying liquidity event is expected to occur.
Discount Rate: The discount rate is applied to future cash flows to calculate their present value.

Recent Accounting Pronouncements

See Note 2, "Summary of significant accounting policies," sections "-Recently Adopted Accounting Pronouncements" and "- Recently Issued Accounting Pronouncements" to our consolidated financial statements, which are included in Item 8 of this Form 10-K.

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