BridgeBio Oncology Therapeutics, Inc.
For the period ended Dec 31, 2025. Filed Mar 5, 2026.
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FY2025 · Filed Mar 5, 2026
Extracted filing text, with the paragraph anchors used by the comparison.
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Table of Contents
| Page | ||
|---|---|---|
| PART I | ||
| Item 1. | Business | 1 |
| Item 1A. | Risk Factors | 42 |
| Item 1B. | Unresolved Staff Comments | 98 |
| Item 1C. | Cybersecurity | 98 |
| Item 2. | Properties | 99 |
| Item 3. | Legal Proceedings | 99 |
| Item 4. | Mine Safety Disclosures | 99 |
| PART II | ||
| Item 5. | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 100 |
| Item 6. | [Reserved] | 100 |
| Item 7. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 101 |
| Item 7A. | Quantitative and Qualitative Disclosures About Market Risk | 114 |
| Item 8. | Financial Statements and Supplementary Data | 115 |
| Item 9. | Changes in and Disagreements With Accountants on Accounting and Financial Disclosure | 144 |
| Item 9A. | Controls and Procedures | 144 |
| Item 9B. | Other Information | 145 |
| Item 9C. | Disclosure Regarding Foreign Jurisdictions that Prevent Inspections | 145 |
| PART III | ||
| Item 10. | Directors, Executive Officers and Corporate Governance | 146 |
| Item 11. | Executive Compensation | 146 |
| Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 146 |
| Item 13. | Certain Relationships and Related Transactions, and Director Independence | 146 |
| Item 14. | Principal Accounting Fees and Services | 146 |
| PART IV | ||
| Item 15. | Exhibits, Financial Statement Schedules | 147 |
| Exhibit Index | 148 | |
| Signatures | 151 | |
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EXPLANATORY NOTE
On August 11, 2025 (the “Closing Date”), Helix Acquisition Corp. II (“Helix”), a Cayman Islands exempted company which domesticated as a Delaware corporation in August 2025, consummated a series of transactions that resulted in the combination of Helix II Merger Sub, Inc., a Delaware corporation and a wholly-owned subsidiary of Helix (“Merger Sub”), and TheRas, Inc. (d/b/a BridgeBio Oncology Therapeutics), a Delaware corporation (“Legacy BBOT”), pursuant to a Business Combination Agreement, dated February 28, 2025, as amended on June 17, 2025 (the “Business Combination Agreement”), by and among Helix, Merger Sub and Legacy BBOT, as described further below.
Pursuant to the terms of the Business Combination Agreement, a business combination between Helix and Legacy BBOT was effected through the merger of Merger Sub with and into Legacy BBOT, with Legacy BBOT surviving the merger as a wholly-owned subsidiary of Helix (the “Business Combination”), following the approval by shareholders of Helix at the extraordinary general meeting of the shareholders of Helix held on August 4, 2025 (the “Special Meeting”). Following the consummation of the Business Combination, Helix was renamed “BridgeBio Oncology Therapeutics, Inc.”
In this Annual Report on Form 10-K (“Form 10-K”), the terms “we,” “us,” “our,” and the “Company” generally refer to Helix Acquisition Corp. II prior to the Business Combination and BridgeBio Oncology Therapeutics, Inc. following the Business Combination, unless the context specifically indicates otherwise. References to “BBOT” include Legacy BBOT prior to the Business Combination and BridgeBio Oncology Therapeutics, Inc. following the Business Combination. Some of the information contained in this section or set forth elsewhere in this Form 10-K, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Form 10-K contains forward‑looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such forward‑looking statements involve substantial risks, uncertainties and assumptions. All statements in this Form 10‑K, other than statements of historical fact, including, without limitation, statements regarding our strategy, future operations, future operating expenses, future financial position, future revenue, projected costs, prospects, plans, intentions, expectations, goals and objectives may be forward‑looking statements. The words “anticipates,” “approximately,” “believes,” “could,” “designed,” “estimates,” “expects,” “goal,” “intends,” “may,” “objective,” “plans,” “potential,” “predicts,” “projects,” “pursuing,” “seeks,” “should,” “will,” “would” and similar expressions (including the negatives thereof) are intended to identify forward‑looking statements, although not all forward‑looking statements contain these identifying words. The forward-looking statements in this report include, but are not limited to, statements about:
expectations related to the success, cost and timing of product development activities, including timing of initiation, completion and data readouts for clinical trials and the potential approval of our product candidates, including the progress and results of the ONKORAS-101, BREAKER-101 and KONQUER-101 clinical trials;
the clinical and therapeutic potential of BBO-8520, BBO-10203 and BBO-11818;
the size and growth potential of the markets for our product candidates;
the therapeutic and curative potential of our product candidates;
projected financial information, anticipated growth rate and market opportunities;
our ability to maintain the listing of our Common Stock on Nasdaq;
potential liquidity and trading volatility of our Common Stock;
our ability to raise financing in the future;
success in retaining or recruiting, or changes required in, officers, key employees or directors;
our ability to obtain and maintain regulatory approval of current and potential future product candidates;
our ability to obtain and maintain intellectual property protection for our technologies and our product candidates;
the rate and degree of market acceptance of current and any potential future product candidates;
regulatory developments in the United States and international jurisdictions;
potential liability lawsuits and penalties related to our technologies, product candidates and current and future relationships with third parties;
our ability to attract and retain key scientific and management personnel;
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our ability to effectively manage the growth of operations;
our ability to compete effectively with existing competitors and new market entrants;
our ability to implement and maintain effective internal controls;
the impact of supply chain disruptions;
unfavorable global economic conditions, including inflationary pressures, market volatility, acts of war and civil and political unrest; and
other factors detailed under the section entitled “Risk Factors” in this Form 10-K.
Any forward-looking statements in this Form 10-K reflect our current views with respect to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under Part I, Item 1A. Risk Factors and elsewhere in this Form 10-K. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.
This Form 10-K also contains estimates, projections and other information concerning our industry, our business, and the markets for certain diseases, including data regarding the estimated size of those markets, and the incidence and prevalence of certain medical conditions. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances reflected in this information. Unless otherwise expressly stated, we obtained this industry, business, market and other data from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data and similar sources.
RISK FACTOR SUMMARY
Below is a summary of the principal factors that make an investment in our common stock speculative or risky. This summary does not address all of the risks that we face. Additional discussion of the risks summarized in this risk factor summary, and other risks that we face, can be found below under the heading “Risk Factors” and should be carefully considered, together with other information in this Annual Report on Form 10-K and our other filings with the U.S. Securities and Exchange Commission, or the SEC, before making investment decisions regarding our common stock.
We have a limited operating history, have not completed any clinical trials, have no products approved for commercial sale, have never commercialized a product, and have not generated any revenue, which may make it difficult for investors to evaluate our current business and likelihood of success and viability.
Our ability to generate revenue and achieve profitability depends significantly on our ability to achieve our objectives relating to the discovery, development and commercialization of our product candidates. If we are unable to advance our product candidates through development, obtain regulatory approval and ultimately commercialize such product candidates, or experience significant delays in doing so, our business will be materially harmed.
We may require additional capital to finance our operations. If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce or eliminate one or more of our research and drug development programs, future commercialization efforts, product development or other operations.
Our preclinical studies and clinical trials may fail to adequately demonstrate the safety and efficacy of any of our product candidates, which would prevent or delay development, regulatory approval and commercialization.
Any delays in the commencement or completion, or any termination or suspension, of our current, planned or future clinical trials could result in increased costs, delay or limit our ability to generate revenue and adversely affect our commercial prospects.
The outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials; interim, preliminary and topline data from our preclinical studies and clinical trials that we announce or publish from time to time may change as more data become available and are subject to audit and verification procedures that could result in material changes in the final data; and the results of our clinical trials may not satisfy the requirements of the FDA, EMA or other comparable foreign regulatory authorities.
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The regulatory approval processes of the FDA, EMA and other comparable foreign regulatory authorities are lengthy, time consuming and inherently unpredictable.
Our product candidates may cause significant adverse events, toxicities or other undesirable adverse events when used alone or in combination with other approved products or investigational new drugs that may result in a safety profile that could prevent regulatory approval, prevent market acceptance, limit their commercial potential or result in significant negative consequences.
We currently rely on third parties to supply and manufacture preclinical and clinical drug supplies, and we intend to rely on third parties to produce commercial supplies of any approved product, which increases the risk that we will not have sufficient quantities of these product candidates or products or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
We face substantial competition which may result in others discovering, developing or commercializing products before or more successfully than we do.
Any product candidates we develop may become subject to unfavorable third-party coverage and reimbursement practices, as well as pricing regulations.
Our business entails a significant risk of product liability.
Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in others, and even if our product candidates receive regulatory approval, they will be subject to significant post-marketing regulatory requirements and oversight.
We may seek certain designations for our product candidates, but we might not receive such designations, and even if we do, such designations may not lead to a faster development or regulatory review or approval process.
We are or may become subject to stringent privacy laws, information security laws, regulations, policies and contractual obligations related to data privacy and security.
Our success is highly dependent on our ability to attract, hire and retain highly skilled executive officers and employees.
If we are unable to obtain, maintain and enforce patent protection for our technology and product candidates, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and products similar or identical to our.
Patent terms may not protect our competitive position for an adequate amount of time.
We may become involved in lawsuits to protect or enforce our patent or other intellectual property rights, which could be expensive, time-consuming and unsuccessful.
We rely on third parties to conduct our preclinical studies and clinical trials, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, research and studies.
There may not be an active trading market for our Common Stock, which may make it difficult to sell shares of our Common Stock.
Future sales, or the perception of future sales, by us or our stockholders in the public market could cause the market price for our securities to decline.
We have identified a material weakness in our internal controls over financial reporting in the past.
We have increased costs as a result of operating as a public company, and our management devotes substantial time to related compliance initiatives.
We are currently in a period of economic uncertainty and capital markets disruption, which has been significantly impacted by a new U.S. presidential administration and accompanying regulatory activities and economic policies and events related thereto, ongoing military conflicts and geopolitical instability and inflation and interest rates.
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PART I
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.