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Sat Oct 24 · markets closed6 signals on Oct 2394 insider buys this week · $48.3MCIRO short report next: Oct 30The week ahead

BBOT

BridgeBio Oncology Therapeutics, Inc.
NASDAQ · HEALTH CARE · PHARMACEUTICAL PREPARATIONS
2.66
−0.19 −6.67%
USD · close Oct 23

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How BBOT rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025
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2017
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New in FY2025

  • 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. iii • 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. iv PART I Item 1.
  • Overview BBOT is a clinical-stage biotechnology company with the mission of transforming the lives of patients with cancers driven by RAS and PI3Kα, the two most frequently mutated oncogenes.
  • Aberrant RAS signaling drives uncontrolled tumor growth in some of the deadliest cancers, including lung, breast, pancreas and colon cancer.
  • This can come from mutations in RAS itself, which underlie approximately 30% of all human cancers, or from RAS-mediated overactivation of PI3Kα.
  • Our goal is to provide meaningful benefit to patients by designing and developing new therapies to achieve high levels of target inhibition against these oncogenic drivers while maintaining a favorable tolerability profile.
  • Our pipeline consists of three orally bioavailable small molecule inhibitors that were designed and optimized within BBOT with the goal to provide patients with significant benefit over standard of care.
  • Additionally, we believe BBOT has the opportunity to provide further benefit to patients with KRAS mutant tumors through combination of our inhibitors.
  • We believe our pipeline has the opportunity to address a large number of patients afflicted with metastatic cancer.
  • BBO-8520 (direct KRAS G12C ON/OFF) and BBO-11818 (direct panKRAS ON/OFF) programs target KRAS — the most mutated oncogene.
  • KRAS is a small GTPase protein that acts like a molecular switch, toggling between the GTP-bound active “ON” state, and the GDP-bound inactive “OFF” state.
  • Oncogenic mutations in KRAS disrupt the normal equilibrium of the two states, resulting in a dramatic increase in the proportion of the “ON” state, and ultimately activating pathways that result in uncontrolled cell growth and cancer progression.
  • The majority of KRAS mutations occur in codon 12.
  • In NSCLC, KRAS G12C mutation are present in approximately 15% of patients.
  • In 2021, the FDA approved the first therapeutic that specifically targets KRAS G12C.
  • However, this first-generation drug and others like it exclusively target the “OFF” state, which renders them susceptible to adaptive resistance, which may limit their efficacy and durability.
  • In addition, patients treated with “OFF” state inhibitors experience significant toxicities which is worse when combined with immune checkpoint inhibitors (ICI).
  • In contrast, BBO-8520, our orally bioavailable dual KRAS G12C “ON/OFF” inhibitor, directly engages both states of the mutant protein.
  • We believe BBO-8520’s next-gen mechanism of action and degree of potency can provide significant benefit to patients with KRAS G12C-driven NSCLC — both as monotherapy and in combination with other therapies.
  • ONKORAS-101 is an ongoing Phase 1 study evaluating BBO-8520 alone and in combination with pembrolizumab in subjects with locally advanced and unresectable or metastatic NSCLC with a KRAS G12C mutation.
  • We disclosed BBO-8520 clinical data in January 2026, where BBO-8520 showed differentiated efficacy, safety and pharmacokinetics with best-in-class potential.
  • We expect to share additional clinical data from ONKORAS-101 in the second half of 2026.
  • BBO-11818, is an orally bioavailable pan KRAS “ON/OFF” inhibitor designed to bind directly to the target.
  • It is able to bind to KRAS G12D, G12V, G12C and WT KRAS with picomolar affinity.
  • In KRAS mutant cells, BBO-11818 has shown low nanomolar potency with greater than 500-fold selectivity for KRAS over H- and NRAS.
  • Like BBO-8520, BBO-11818 was designed to inhibit KRAS in both its “ON” and “OFF” states.
  • We believe these properties will enable BBO-11818 to achieve optimal target inhibition to provide significant benefit to patients with tumors driven by these oncogenes while maintaining a favorable tolerability profile.
  • The KONQUER-101 trial is a currently ongoing phase 1 study evaluating the safety and preliminary antitumor activity of BBO-11818 in heavily pretreated subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors.
  • Preliminary BBO-11818 monotherapy data is encouraging as we have observed anti-tumor activity with a favorable and differentiated safety profile.
  • We expect to share additional clinical data from KONQUER-101 in the second half of 2026.

and 1977 more.

Gone since FY2024

  • Risk Factors” Overview We are a special purpose acquisition company incorporated in the Cayman Islands on June 15, 2021, formed for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or other similar Business Combination with one or more businesses.
  • We intend to effectuate our initial business combination using cash derived from the proceeds of the IPO and the sale of the Private Placement Shares, our shares, debt or a combination of cash, shares and debt.
  • We expect to continue to incur significant costs in the pursuit of our acquisition plans.
  • We cannot assure you that our plans to complete an initial business combination will be successful.
  • Results of Operations We have neither engaged in any operations nor generated any revenues to date.
  • Our only activities from June 15, 2021 (inception) through December 31, 2024 were organizational activities, those necessary to prepare for the IPO, described below, and subsequent to the IPO, identifying a target company for an initial business combination.
  • We do not expect to generate any operating revenues until after the completion of our initial business combination.
  • We generate non-operating income in the form of interest income on marketable securities held in the Trust Account.
  • We incur expenses as a result of being a public company (for legal, financial reporting, accounting and auditing compliance), as well as for due diligence expenses.
  • For the year ended December 31, 2024, we had net income of $7,599,512, which consisted of interest earned on marketable securities held in the Trust Account of $8,449,291 and interest earned on bank deposits of $6,182, partially offset by general and administrative expenses of $584,389 and share-based compensation expense of $271,572.
  • For the year ended December 31, 2023, we had net income loss of $41,692, which consisted of formation and operational costs.
  • Liquidity and Capital Resources Until the consummation of the IPO, our only source of liquidity was an initial purchase of shares of Class B ordinary shares, par value $0.0001 per share, by the Sponsor and loans from the Sponsor.
  • On February 13, 2024, we consummated the IPO of 18,400,000 Class A ordinary shares, which includes the full exercise by the underwriter of its over-allotment option in the amount of 2,400,000 Class A ordinary shares, at $10.00 per Class A ordinary share, generating gross proceeds of $184,000,000.
  • Simultaneously with the closing of the IPO, the Company consummated the sale of 509,000 Private Placement Shares to the Sponsor, at a price of $10.00 per Private Placement Share, generating gross proceeds of $5,090,000.
  • Following the IPO and the private placement, a total of $184,000,000 ($10.00 per Share) was placed in the Trust Account.
  • We incurred $8,180,834 in IPO related costs, including $1,840,000 of upfront cash underwriting fee, $5,520,000 of deferred underwriting fee and $820,834 of other offering costs.
  • For the year ended December 31, 2024, cash used in operating activities was $763,820.
  • Net income of $7,599,512 was affected by interest earned on marketable securities held in the Trust Account of $8,449,291, non-cash accrued offering costs adjustment of $81,000, and share-based compensation of $271,572.
  • Changes in operating assets and liabilities used $104,613 of cash for operating activities.
  • For the year ended December 31, 2023, there was $0 cash used in operating activities.
  • Net loss of $41,692 was affected by formation and operation expenses paid by Sponsor of $26,692 and changes in operating assets and liabilities which provided $15,000 for operating activities.
  • As of December 31, 2024, we had marketable securities held in the Trust Account of $192,449,291 (including $8,449,291 of interest income).
  • The Trust Account is either held in cash, deposited into an interest bearing or non-interest bearing bank demand deposit account at a U.S. chartered commercial bank with consolidated assets of $100 billion or more, or invested only in U.S. government treasury obligations with a maturity of 185 days or less or interests in money market funds meeting certain conditions under Rule 2a-7 under the Investment Company Act, which invest only in direct U.S. government treasury obligations, as determined by the Company.
  • We may withdraw interest from the Trust Account to pay taxes, if any.
  • We intend to use substantially all of the funds held in the Trust Account, including any amounts representing interest earned on the Trust Account (less deferred underwriting commissions and taxes payable), to complete our initial business combination.
  • To the extent that our capital stock or debt is used, in whole or in part, as consideration to complete our initial business combination, the remaining proceeds held in the Trust Account will be used as working capital to finance the operations of the target business or businesses, make other acquisitions and pursue our growth strategies.
  • As of December 31, 2024 and 2023, we had cash of $1,697,777 and $0, respectively.
  • We intend to use the funds held outside the Trust Account primarily to identify and evaluate target businesses, perform business due diligence on prospective target businesses, travel to and from the offices, plants or similar locations of prospective target businesses or their representatives or owners, review corporate documents and material agreements of prospective target businesses, structure, negotiate and complete an initial business combination, to pay for directors and officers liability insurance premiums and to pay an aggregate of $6,458 per month to our Sponsor for office space, utilities, administrative services and remote support services.
  • In order to finance working capital deficits or to finance transaction costs in connection with an intended initial business combination, the Sponsor or an affiliate of the Sponsor or certain of the Company’s officers and directors may, but are not obligated to, loan the Company funds as may be required.
  • If the Company completes an initial business combination, the Company would repay the Working Capital Loans.
  • In the event that the initial business combination does not close, the Company may use a portion of the working capital held outside the Trust Account to repay the Working Capital Loans but no proceeds from the Trust Account would be used to repay the Working Capital Loans.
  • Up to $1,500,000 of the Working Capital Loans may be convertible into Private Placement Shares of the post business combination entity at a price of $10.00 per private placement share at the option of the lender.
  • Such shares would be identical to the Private Placement Shares.
  • We believe that amounts not held in trust will be sufficient to pay the costs and expenses to which such proceeds are allocated that are payable prior to the closing of our initial business combination, which we have 24 months from the consummation of the IPO to complete.
  • However, if our estimate of the costs of identifying a target business, undertaking in-depth due diligence and negotiating a business combination are less than the actual amount necessary to do so, we may have insufficient funds available to operate our business prior to our initial business combination.
  • Moreover, we may need to obtain additional financing either to complete our business combination or because we become obligated to redeem a significant number of our Public Shares upon completion of our business combination, in which case we may issue additional securities or incur debt in connection with such Business Combination.
  • We have determined that mandatory liquidation, should the initial business combination not occur by February 14, 2026, and potential subsequent dissolution, raise substantial doubt about our ability to continue as a going concern for a reasonable period of time which is considered to be one year from the date of the issuance of the financial statements.
  • The financial statements do not include any adjustments relating to the recovery of the recorded assets or the classification of the liabilities that might be necessary should we be unable to continue as a going concern.
  • Off-Balance Sheet Arrangements We have no obligations, assets or liabilities, which would be considered off-balance sheet arrangements as of December 31, 2024.
  • We do not participate in transactions that create relationships with unconsolidated entities or financial partnerships, often referred to as variable interest entities, which would have been established for the purpose of facilitating off-balance sheet arrangements.

and 568 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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