BridgeBio Oncology Therapeutics, Inc.

Current report

Investing in our common stock involves a high degree of risk. You should carefully read and consider all of the risks described below, as well as the other information in this Form 10-Q, including our financial statements and the related notes and the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and in other documents we file with the SEC when evaluating our business. The occurrence of any of the events or developments described below could harm our business, financial condition, results of operations and growth prospects. Unless otherwise indicated, references to our business being harmed in these risk factors will include harm to our business, reputation, financial condition, results of operations and future prospects. In such an event, the market price of our common stock could decline, and you may lose all or part of your investment. The risks described below are not intended to be exhaustive and are not the only risks that we face. Additional risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations and the market price of our common stock.

Current report

Summary of Material Risks

Current report

BBOT has a limited operating history, has not completed any clinical trials, has no products approved for commercial sale, has never commercialized a product, and has not generated any revenue, which may make it difficult for investors to evaluate BBOT’s current business and likelihood of success and viability.

Current report

BBOT’s ability to generate revenue and achieve profitability depends significantly on its ability to achieve its objectives relating to the discovery, development and commercialization of its product candidates. If BBOT is unable to advance its product candidates through development, obtain regulatory approval and ultimately commercialize such product candidates, or experience significant delays in doing so, BBOT’s business will be materially harmed.

Current report

BBOT may require additional capital to finance its operations. If BBOT is unable to raise such capital when needed, or on acceptable terms, BBOT may be forced to delay, reduce or eliminate one or more of its research and drug development programs, future commercialization efforts, product development or other operations.

Current report

BBOT’s preclinical studies and clinical trials may fail to adequately demonstrate the safety and efficacy of any of its product candidates, which would prevent or delay development, regulatory approval and commercialization.

Current report

Any delays in the commencement or completion, or any termination or suspension, of BBOT’s current, planned or future clinical trials could result in increased costs to BBOT, delay or limit BBOT’s ability to generate revenue and adversely affect BBOT’s commercial prospects.

Current report

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 BBOT’s preclinical studies and clinical trials that BBOT announces or publishes 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 BBOT’s clinical trials may not satisfy the requirements of the FDA, EMA or other comparable foreign regulatory authorities.

Current report

The regulatory approval processes of the FDA, EMA and other comparable foreign regulatory authorities are lengthy, time consuming and inherently unpredictable.

Current report

BBOT’s 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.

Current report

BBOT currently relies on third parties to supply and manufacture preclinical and clinical drug supplies, and BBOT intends to rely on third parties to produce commercial supplies of any approved product, which increases the risk that BBOT will not have sufficient quantities of these product candidates or products or such quantities at an acceptable cost, which could delay, prevent or impair BBOT’s development or commercialization efforts.

Current report

BBOT faces substantial competition which may result in others discovering, developing or commercializing products before or more successfully than BBOT does.

Current report

Any product candidates BBOT develops may become subject to unfavorable third-party coverage and reimbursement practices, as well as pricing regulations.

Current report

BBOT’s business entails a significant risk of product liability.

Current report

Obtaining and maintaining regulatory approval of BBOT’s product candidates in one jurisdiction does not mean that BBOT will be successful in obtaining regulatory approval of its product candidates in others, and even if BBOT’s product candidates receive regulatory approval, they will be subject to significant post-marketing regulatory requirements and oversight.

Current report

BBOT may seek certain designations for its product candidates, but BBOT might not receive such designations, and even if BBOT does, such designations may not lead to a faster development or regulatory review or approval process.

Current report

BBOT is or may become subject to stringent privacy laws, information security laws, regulations, policies and contractual obligations related to data privacy and security.

Current report

BBOT’s success is highly dependent on BBOT’s ability to attract, hire and retain highly skilled executive officers and employees.

Current report

If BBOT is unable to obtain, maintain and enforce patent protection for its technology and product candidates, or if the scope of the patent protection obtained is not sufficiently broad, BBOT’s competitors could develop and commercialize technology and products similar or identical to BBOT’s.

Current report

Patent terms may not protect BBOT’s competitive position for an adequate amount of time.

Current report

BBOT may become involved in lawsuits to protect or enforce its patent or other intellectual property rights, which could be expensive, time-consuming and unsuccessful.

Current report

BBOT relies on third parties to conduct its 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.

Current report

There may not be an active trading market for Common Stock, which may make it difficult to sell shares of Common Stock.

Current report

Future sales, or the perception of future sales, by BBOT or its stockholders in the public market could cause the market price for BBOT’s securities to decline.

Current report

BBOT has identified a material weakness in its internal controls over financial reporting.

Current report

BBOT has increased costs as a result of operating as a public company, and BBOT’s management devotes substantial time to related compliance initiatives.

Current report

Risks Related to BBOT’s Financial Position and Need for Additional Capital

Current report

BBOT has a limited operating history, has not completed any clinical trials, has no products approved for commercial sale and has not generated any revenue, which may make it difficult for investors to evaluate BBOT’s current business and likelihood of success and viability.

Current report

BBOT is a biopharmaceutical company with a limited operating history upon which investors can evaluate its business and prospects. BBOT was incorporated in August 2016 and commenced significant operations as an independent entity starting in May 2024, has never completed a clinical trial, has no products approved for commercial sale and has never generated any revenue. Drug development is a highly uncertain undertaking and involves a substantial degree of risk. To date, BBOT has devoted substantially all of its resources to research and development activities, including with respect to BBO-8520, BBO-10203 and BBO-11818, and its discovery programs, business planning, establishing and maintaining its intellectual property portfolio, hiring personnel, raising capital and providing general and administrative support for these operations.

Current report

BBOT has not yet demonstrated its ability to successfully complete clinical trials, obtain marketing approvals, manufacture a commercial-scale product or arrange for a third party to do so on its behalf, or conduct sales and marketing activities necessary for successful product commercialization. As a result, it may be more difficult for investors to evaluate BBOT’s likelihood of success and viability.

Current report

In addition, BBOT may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors and risks frequently experienced by biopharmaceutical companies at BBOT’s stage of development in rapidly evolving fields. BBOT also expects that, as BBOT advances its product candidates, BBOT will need to transition from a company with a research and development focus to a company capable of supporting commercial activities. BBOT has not yet demonstrated an ability to successfully overcome such risks and difficulties, or to make such a transition. If BBOT does not adequately address these risks and difficulties or successfully make such a transition, its business will suffer.

Current report

BBOT has incurred significant net losses in each period since its inception, and expects to continue to incur significant net losses for the foreseeable future.

Current report

BBOT incurred significant net losses in each reporting period since its inception, has not generated any revenue to date and has financed its operations principally through private placements of securities. BBOT’s net losses were $95.2 million and $54.6 million for the nine months ended September 30, 2025 and 2024, respectively, and $74.3 million and $64.7 million for the years ended December 31, 2024 and 2023, respectively. As of September 30, 2025, BBOT had an accumulated deficit of $317.8 million. BBOT has not yet completed any clinical trials. As a result, BBOT expects that it will be several years, if ever, before BBOT generates revenue from product sales. Even if BBOT succeeds in receiving marketing approval for and commercializing one or more product candidates, BBOT expects that it will continue to incur substantial research and development and other expenses in order to discover, develop and market additional potential products.

Current report

BBOT expects to continue to incur significant and increasing expenses and increasing operating losses for the foreseeable future. The net losses BBOT incurs may fluctuate significantly from quarter to quarter such that a period-to-period comparison of BBOT’s results of operations may not be a good indication of future performance. The size of future net losses will depend, in part, on the pace of development activities and the rate of future growth of expenses and BBOT’s ability to generate revenue. BBOT’s prior losses and expected future losses have had and will continue to have an adverse effect on working capital, BBOT’s ability to fund the development of its product candidates and its ability to achieve and maintain profitability and the performance of its stock.

Current report

BBOT’s ability to generate revenue and achieve profitability depends significantly on its ability to achieve its objectives relating to the discovery, development and commercialization of its product candidates.

Current report

BBOT relies on its team’s expertise in chemistry, structure-based drug design, oncology drug development, business development and patient-driven approach to develop its product candidates. BBOT’s business depends significantly on the success of its approach and the development and commercialization of the product candidates that BBOT discovers with this approach. BBOT has no products approved for commercial sale and does not anticipate generating any revenue from product sales for the next several years, if ever. BBOT’s ability to generate revenue and achieve profitability depends significantly on its ability to achieve several objectives, including:

Current report

successful and timely completion of preclinical and clinical development of BBO-8520, BBO-10203, BBO-11818 and any future product candidates from BBOT’s discovery program

Current report

maintaining current and establishing new relationships with contract research organizations (“CROs”) and clinical sites for the clinical development of BBO-8520, BBO-10203, BBO-11818 and any future product candidates from BBOT’s current or future discovery programs;

Current report

timely receipt of marketing approvals from applicable regulatory authorities for any product candidates for which BBOT successfully completes clinical development;

Current report

developing an efficient and scalable manufacturing process for BBOT’s product candidates, including the production of finished products that are appropriately packaged for sale if BBOT’s product candidates obtain marketing approvals;

Previous report

Factors that could cause our actual results to differ materially from those in this Quarterly Report are any of the risks described in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 11, 2025. Any of these factors could result in a significant or material adverse effect on our results of operations or financial condition. Additional risk factors not presently known to us or that we currently deem immaterial may also impair our business or results of operations. As of the date of this Quarterly Report, except as described below, there have been no material changes to the risk factors disclosed in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC, except we may disclose changes to such factors or disclose additional factors from time to time in our future filings with the SEC.

Current report — wording carried from elsewhere

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.