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us-gaap:AllOtherSegmentsMember 2025-04-01 2025-06-30 0001839970 2026-04-01 2026-06-30 0001839970 us-gaap:SeriesBPreferredStockMember 2025-01-01 2025-12-31 0001839970 us-gaap:CommonStockMember 2026-03-31 0001839970 us-gaap:AdditionalPaidInCapitalMember 2026-03-31 0001839970 us-gaap:RetainedEarningsMember 2024-12-31 0001839970 us-gaap:SeriesBPreferredStockMember 2024-12-31 iso4217:USD xbrli:shares xbrli:pure xbrli:shares blsm:Segment iso4217:USD UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2026 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ to ____ Commission File Number: 001-43435 BlossomHill Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 85-1578711 ( State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 10255 Science Center Drive Suite 200 San Diego , CA 92121 (Address of principal executive offices) (Zip Code) Registrant’s telephone number, including area code: ( 858 ) 732-3880 Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, $0.0001 par value per share BLSM The Nasdaq Global Select Market Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☐ No ☒ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. Large accelerated filer ☐ Accelerated filer ☐ Non-accelerated filer ☒ Smaller reporting company ☒ Emerging growth company ☒ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒ As of September 16, 2026, the registrant had 31,784,909 shares of common stock, $0.0001 par value per share, outstanding. Table of Contents Page PART I. FINANCIAL INFORMATION 1 Item 1. Financial Statements (Unaudited) 1 Condensed Balance Sheets 2 Condensed Statements of Operations 3 Condensed Statements of Convertible Preferred Stock and Stockholders' Deficit 4 Condensed Statements of Cash Flows 6 Notes to Condensed Financial Statements 7 Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 15 Item 3. Quantitative and Qualitative Disclosures About Market Risk 24 Item 4. Controls and Procedures 24 PART II. OTHER INFORMATION 25 Item 1. Legal Proceedings 25 Item 1A. Risk Factors 25 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 80 Item 3. Defaults Upon Senior Securities 81 Item 4. Mine Safety Disclosures 81 Item 5. Other Information 81 Item 6. Exhibits 82 Signatures 84 i SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Quarterly Report on Form 10-Q contains express or implied forward-looking statements about us and our industry that involve substantial risks and uncertainties, within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act). All statements other than statements of historical fact contained in this Quarterly Report on Form 10-Q, including statements regarding our plans, objectives, goals, strategies, future events, future revenues or performance, financing needs, plans, or intentions relating to our product candidates and development programs and markets and business trends are forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections. In some cases, investors can identify forward-looking statements because they contain words such as “aim,” “anticipate,” “assume,” “believe,” “can,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “positioned,” “potential,” “predict,” “project,” “seek,” “shall,” “should,” “target,” “will,” “would” or the negative of these words or other similar terms or expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements include, but are not limited to, statements about: • the initiation, timing, progress and results of our research and development programs, preclinical studies and clinical trials; • our ability to develop and advance BH-30643, BH-30236, BH-501284 and any future product candidates as both monotherapy and combination therapy regimens; • the timing of and costs involved in obtaining and maintaining regulatory approval of BH-30643, BH-30236, BH-501284 and any future product candidates that we may identify or develop; • the beneficial characteristics, including potential safety, efficacy and therapeutic effects of BH-30643, BH-30236 and BH-501284; • our ability to efficiently and cost-effectively conduct our current and future preclinical studies and clinical trials; • our ability to obtain funding for our operations necessary to complete further development and, if approved, commercialization of BH-30643, BH-30236 and BH-501284; • our ability to identify and develop BH-30643, BH-30236 and BH-501284 for the treatment of additional indications; • the performance of our third-party service providers, including our suppliers and manufacturers; • the rate and degree of market acceptance and clinical utility for BH-30643, BH-30236, BH-501284 and any other product candidates we may develop; • the effects of competition with respect to BH-30643, BH-30236 and BH-501284 or any other product candidates we may develop, as well as innovations by competitors in our industry; • our estimates regarding the potential market opportunities and the number of patients for BH-30643, BH-30236, BH-501284 and any future product candidates, if approved for commercial use; • the implementation of our strategic plans for our business, BH-30643, BH-30236, BH-501284 and any future product candidates we may develop; • our intellectual property position, including the scope of protection we are able to establish, maintain, defend and enforce for intellectual property rights covering BH-30643, BH-30236, BH-501284 and any future product candidates we may develop; • our ability to attract and retain key scientific or management personnel; • regulatory and legal developments in the United States or other countries where we conduct clinical development or other business operations; • our ability to attract and retain employees and collaborators with development, regulatory and commercialization expertise; • the accuracy of our estimates regarding future expenses, future revenue, capital requirements and need for additional financing; • the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements; • our expectations regarding the impact of global health pandemics, geopolitical conflicts and economic uncertainty, including interest rate changes and inflation on our business and operations, including clinical trials, collaborators, clinical research organizations (CROs) and employees; • our expectations regarding the period during which we qualify as an emerging growth company under the JOBS Act; and ii • other risks and uncertainties, including those listed under the section titled “Risk Factors” in Part II, Item 1A of this Quarterly Report on Form 10-Q. These forward-looking statements reflect our management’s beliefs and views with respect to future events and are based on estimates and assumptions as of the date of this Quarterly Report on Form 10-Q and are subject to risks and uncertainties. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report on Form 10-Q, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements. We discuss many of the risks associated with the forward-looking statements in this Quarterly Report on Form 10-Q in greater detail in the section titled “Risk Factors.” Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, investors should not place undue reliance on these forward-looking statements. Investors should carefully read this Quarterly Report on Form 10-Q and the documents that we reference in this Quarterly Report on Form 10-Q and have filed as exhibits hereto completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of the forward-looking statements in this Quarterly Report on Form 10-Q by these cautionary statements. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in any forward-looking statements, whether as a result of new information, future events, or otherwise. iii RISK FACTOR SUMMARY Our business is subject to numerous risks and uncertainties, including those described in Part II, Item 1A, “Risk Factors” in this Quarterly Report on Form 10-Q. The following is a summary of the principal risks and uncertainties described in more detail in this Quarterly Report on Form 10-Q: • We are a clinical-stage biopharmaceutical company with a limited operating history. We have not completed any pivotal or late-stage clinical trials and we have no history of commercializing products, which may make it difficult to evaluate our approach to the discovery and development of our product candidates and the prospects for our future viability. • We have incurred substantial losses since our inception. We anticipate incurring substantial and increasing losses for the foreseeable future and may never achieve or maintain profitability. • We will require substantial additional financing to achieve our goals, which may cause dilution to our stockholders, and failure to obtain additional capital when needed, or on acceptable terms, could cause us to delay, limit, reduce or terminate our product development or future commercialization efforts. • Our discovery and development programs are focused in part on precision medicines for patients with genetically defined cancers, which is a rapidly evolving and scientifically uncertain field, and our scientific approach, including with respect to BH-30643, BH-30236 and BH-501284, may never lead to marketable products. • We are early in our development efforts and only have two product candidates, BH-30643 and BH-30236, in early clinical development. Our pan-KRAS product candidate, BH-501284, is in the preclinical stage. If we are unable to continue to advance our product candidates through or into clinical development, obtain regulatory approval and ultimately commercialize our product candidates or we experience significant delays in doing so, our business will be materially harmed. • Preclinical and clinical development involves a lengthy and expensive process, with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial or real-world results. Our product candidates may not have favorable results in preclinical studies or clinical trials or receive regulatory approval on a timely basis, if at all. • Use of our product candidates could be associated with adverse side effects, adverse events or other safety risks, which could delay or preclude the candidate’s approval, cause us to suspend or discontinue clinical trials, cause us to abandon the product candidates, limit the commercial profile of any future approved product or result in other significant negative consequences that could severely harm our business, prospects, operating results and financial condition. • We are currently developing and may in the future develop our product candidates in combination with other therapies, and safety or supply issues with combination-use products may delay or prevent development and approval of our product candidates. • We are dependent on the services of our management and other clinical and scientific personnel, and if we are not able to retain these individuals or recruit additional management or clinical and scientific personnel, our business will suffer. In addition, prior successes of our personnel may not be indicative of our future success. • Our success depends in large part on our ability to obtain, maintain, enforce, and defend the scope, ownership or control, validity and enforceability of our intellectual property rights, and we may not be able to do so. • We rely on third parties to conduct our preclinical studies and clinical trials. If these third parties that we rely on to execute our preclinical studies or clinical trials do not successfully carry out their contractual duties, comply with applicable regulatory requirements or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our product candidates. • We rely on third-party manufacturers and suppliers to supply our product candidates. The loss of our third-party manufacturers or suppliers, or their failure to comply with applicable regulatory requirements or to supply sufficient quantities at acceptable quality levels or prices, within acceptable timeframes, or at all, would materially and adversely affect our business. • Competitive products may reduce or eliminate the commercial opportunity for our product candidates for our current or future indications. If our competitors develop technologies or product candidates more rapidly than we do, or their technologies are more effective or safer than ours, our ability to develop and successfully commercialize our product candidates may be adversely affected. • Even if our product candidates receive regulatory approval, they may fail to achieve the degree of market acceptance by physicians, patients and others in the medical community necessary for commercial success, in which case we may not generate significant revenues or become profitable. • The successful commercialization of our product candidates, if approved, will depend in part on the extent to which governmental authorities and health insurers establish coverage, adequate reimbursement levels, and favorable pricing policies. Failure to obtain or maintain coverage and adequate reimbursement for our product candidates could limit our ability to market those products and decrease our ability to generate revenue. iv • The trading price of our common stock is likely to be volatile and you could lose all or part of your investment. The above summary is not complete and is qualified in its entirety by the more detailed discussion of these and other risks and uncertainties set forth in Part II, Item 1A, “Risk Factors” in this Quarterly Report on Form 10-Q, which you should read carefully together with all of the other information contained in this Quarterly Report on Form 10-Q before making an investment decision. v PART I—FIN ANCIAL INFORMATION Ite m 1. Financial Statements. 1 BLOSSOMHILL THERAPEUTICS, INC. UNAUDITED COND ENSED BALANCE SHEETS (in thousands, except share and par value data) June 30, 2026 December 31, 2025 (unaudited) Assets Current Assets: Cash and cash equivalents $ 95,376 $ 136,682 Prepaid expenses and other current assets 5,592 2,144 Total current assets 100,968 138,826 Property and equipment, net 1,489 1,726 Operating lease right-of-use assets 19,197 19,921 Other assets 2,477 2,495 Total assets $ 124,131 $ 162,968 Liabilities, convertible preferred stock and stockholders' deficit Current liabilities: Accounts payable $ 3,930 $ 2,314 Accrued expenses 9,194 8,431 Accrued compensation 3,539 4,730 Other current liabilities 809 - Operating lease liability, current 1,149 5 Total current liabilities 18,621 15,480 Operating lease liability, non-current 22,222 22,393 Other long-term liabilities 1,245 - Total liabilities 42,088 37,873 Commitments and contingencies (Note 6) Convertible preferred stock, $ 0.0001 par value; 85,552,612 shares authorized at June 30, 2026 and December 31, 2025; 18,258,960 shares issued and outstanding at June 30, 2026 and December 31, 2025; $ 257,153 aggregate liquidation preference at June 30, 2026 and December 31, 2025 256,823 256,823 Stockholders' deficit: Common stock, $ 0.0001 par value; 110,000,000 shares authorized at June 30, 2026 and December 31, 2025; 2,767,848 and 2,548,659 shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively. 1 1 Additional paid-in capital 5,014 3,300 Accumulated deficit ( 179,795 ) ( 135,029 ) Total stockholders' deficit ( 174,780 ) ( 131,728 ) Total liabilities, convertible preferred stock and stockholders' deficit $ 124,131 $ 162,968 The accompanying notes are an integral part of these unaudited condensed financial statements. 2 BLOSSOMHILL THERAPEUTICS, INC. UNAUDITED CONDENSED ST ATEMENTS OF OPERATIONS (in thousands, except share and per share data) Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Operating expenses: Research and development $ 21,355 $ 12,530 $ 41,256 $ 22,102 General and administrative 3,315 1,573 5,521 3,455 Total operating expenses 24,670 14,103 46,777 25,557 Loss from operations ( 24,670 ) ( 14,103 ) ( 46,777 ) ( 25,557 ) Other income (expense), net: Interest income, net 915 859 2,017 1,835 Other expense, net ( 3 ) - ( 6 ) - Total other income, net 912 859 2,011 1,835 Net loss $ ( 23,758 ) $ ( 13,244 ) $ ( 44,766 ) $ ( 23,722 ) Net loss per share, basic and diluted $ ( 8.75 ) $ ( 5.51 ) $ ( 16.91 ) $ ( 9.90 ) Weighted average common shares outstanding, basic and diluted 2,713,696 2,405,140 2,646,721 2,395,789 The accompanying notes are an integral part of these unaudited condensed financial statements. 3 BLOSSOMHILL THERAPEUTICS, INC. UNAUDITED CONDENSED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLD ERS’ DEFICIT (in thousands, except share data) Common Stock Additional Paid-In Capital Accumulated Deficit Total Stockholders' Deficit Convertible Preferred Stock Shares Amount Shares Amount Balance at March 31, 2026 18,258,960 $ 256,823 2,644,326 $ 1 $ 3,916 $ ( 156,037 ) $ ( 152,120 ) Exercise of stock options - - 107,191 - 447 - 447 Vesting of restricted common stock - - 16,331 - 74 - 74 Stock-based compensation expense - - - - 577 - 577 Net loss - - - - - ( 23,758 ) ( 23,758 ) Balance at June 30, 2026 18,258,960 256,823 2,767,848 1 5,014 ( 179,795 ) ( 174,780 ) Balance at December 31, 2025 18,258,960 $ 256,823 2,548,659 $ 1 $ 3,300 $ ( 135,029 ) $ ( 131,728 ) Exercise of stock options - - 202,858 - 740 - 740 Vesting of restricted common stock - - 16,331 - 74 - 74 Stock-based compensation expense - - - - 900 - 900 Net loss - - - - ( 44,766 ) ( 44,766 ) Balance at June 30, 2026 18,258,960 $ 256,823 2,767,848 $ 1 $ 5,014 $ ( 179,795 ) $ ( 174,780 ) The accompanying notes are an integral part of these unaudited condensed financial statements. 4 BLOSSOMHILL THERAPEUTICS, INC. UNAUDITED CONDENSED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDE RS’ EQUITY (DEFICIT) (in thousands, except share data) Convertible Preferred Stock Common Stock Additional Paid-In Capital Accumulated Deficit Total Stockholders' Deficit Shares Amount Shares Amount Balance at March 31, 2025 13,485,975 $ 172,886 2,394,437 $ 1 $ 1,860 $ ( 84,952 ) $ ( 83,091 ) Exercise of stock options - - 16,579 - 47 - 47 Stock-based compensation expense - - - - 254 - 254 Net loss - - - - - ( 13,244 ) ( 13,244 ) Balance at June 30, 2025 13,485,975 172,886 2,411,016 1 2,161 ( 98,196 ) ( 96,034 ) Balance at December 31, 2024 13,485,975 $ 172,886 2,381,320 $ 1 $ 1,590 $ ( 74,474 ) $ ( 72,883 ) Exercise of stock options - - 29,696 - 86 - 86 Stock-based compensation expense - - - - 485 - 485 Net loss - - - - ( 23,722 ) ( 23,722 ) Balance at June 30, 2025 13,485,975 $ 172,886 2,411,016 $ 1 $ 2,161 $ ( 98,196 ) $ ( 96,034 ) The accompanying notes are an integral part of these unaudited condensed financial statements. 5 BLOSSOMHILL THERAPEUTICS, INC. UNAUDITED CONDENSED ST ATEMENTS OF CASH FLOWS (in thousands) Six Months Ended June 30, 2026 2025 Cash flows from operating activities: Net loss $ ( 44,766 ) $ ( 23,722 ) Adjustments to reconcile net loss to net cash used in operations Depreciation expense 250 187 Non-cash lease expense 724 482 Stock-based compensation expense 900 485 Changes in operating assets and liabilities: Prepaid expenses and other assets ( 2,323 ) 2,251 Other assets 18 ( 1,484 ) Accounts payable 1,616 ( 180 ) Accrued expenses ( 373 ) 1,341 Accrued compensation ( 1,191 ) 471 Operating lease liabilities 971 48 Net cash used in operating activities ( 44,174 ) ( 20,121 ) Cash flows from investing activities: Purchases of property and equipment ( 13 ) ( 997 ) Net cash used in investing activities ( 13 ) ( 997 ) Cash flows from financing activities: Proceeds from the exercise of stock options 2,881 85 Net cash provided by financing activities 2,881 85 Net increase (decrease) in cash and cash equivalents ( 41,306 ) ( 21,033 ) Cash and cash equivalents at the beginning of period 136,682 100,147 Cash and cash equivalents at the end of period $ 95,376 $ 79,114 Supplemental disclosure of noncash activities: Right-of-use asset obtained in exchange for operating lease liability — $ 20,927 Deferred financing costs included in accounts payable and accrued expenses $ 1,136 — The accompanying notes are an integral part of these unaudited condensed financial statements. 6 BLOSSOMHILL THERAPEUTICS, INC. NOTES TO UNAUDITED CON DENSED FINANCIAL STATEMENTS Note 1. Organization, liquidity and going concern and basis of presentation Organization BlossomHill Therapeutics, Inc. (the “Company”) is a clinical-stage biopharmaceutical company applying its intentional, chemistry-based approach to develop innovative small molecule medicines that address significant unmet medical needs in cancer treatment. The Company was incorporated in the State of Delaware on June 22, 2020, and its principal operations are in San Diego, California. From its inception to June 30, 2026, the Company has devoted substantially all of its resources to conducting research and development, staffing the Company, establishing and protecting the Company’s intellectual property portfolio, scaling up manufacturing processes and supplying product candidates and other materials for the Company’s preclinical studies and clinical trials, leasing office and laboratory space, raising capital, business planning and providing general and administrative support for these activities. The Company’s operations through June 30, 2026 have been funded primarily through the issuance of convertible preferred stock. Liquidity and Going Concern In accordance with Accounting Standards Codification (“ASC”) Topic 205-40, Going Concern , the Company evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year from the date that these financial statements are issued. The Company has incurred net losses and negative cash flows from operations since inception, has a significant accumulated deficit and expects to continue to incur net losses for the foreseeable future. The Company has never generated any revenue from product sales and does not expect to generate any revenues from product sales unless and until it successfully completes development of and obtains regulatory approval for its product candidates, which will not be for several years, if ever. The Company has an accumulated deficit of $ 179.8 million as of June 30, 2026. During the six months ended June 30, 2026 , the Company used $ 44.2 million of cash for operating activities. As of June 30, 2026 , the Company had $ 95.4 million in cash and cash equivalents. In August 2026, the Company closed on its Initial Public Offering (the “IPO”), in which the Company received aggregate net proceeds of $ 151.7 million , inclusive of the partial exercise of the underwriters’ option to purchase additional shares (the “IPO Proceeds”). Management believes that the Company’s existing cash resources, together with the IPO Proceeds, will be sufficient to fund operations for at least 12 months following the issuance of these unaudited condensed financial statements. If the Company is unable to obtain additional funding before achieving sufficient profitability and positive cash flows from operations, the Company will be forced to delay, reduce or eliminate some or all of its research and development programs, which could adversely affect its business prospects, or the Company may be unable to continue operations. Although management continues to pursue plans to obtain additional funding before achieving sufficient profitability and positive cash flows from operations, there is no assurance that the Company will be successful in obtaining sufficient funding on terms acceptable to the Company to fund continuing operations, if at all. Basis of Presentation The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) and pursuant to rules and regulations of the Securities and Exchange Commission for interim financial information. These unaudited condensed financial statements include only normal and recurring adjustments that the Company believes are necessary to fairly state the Company’s financial position and the results of its operations and cash flows. The results for the three months ended June 30, 2026 are not necessarily indicative of the results expected for the full fiscal year or any subsequent interim period. The unaudited condensed balance sheet as of June 30, 2026 has been derived from the financial statements as of that date but does not include all disclosures required by GAAP for complete financial statements. As all of the disclosures required by GAAP for complete financial statements are not included herein, these unaudited condensed financial statements and the notes accompanying herein should be read in conjunction with the Company’s audited financial statements as of and for the years ended December 31, 2024 and 2025 included in the Company’s final prospectus dated August 7, 2026 related to its IPO filed pursuant to Rule 424(b)(4) under the Securities Act of 1933, as amended. Any reference in these notes to applicable guidance is meant to refer 7 to GAAP as found in the ASC and Accounting Standards Updates (“ASU”) promulgated by the Financial Accounting Standards Board (“FASB”). Unaudited Condensed Interim Financial Information The unaudited condensed balance sheet as of June 30, 2026, the unaudited condensed statements of operations for the three and six months ended June 30, 2026 and 2025, the unaudited condensed statements of convertible preferred stock and stockholders’ deficit for the three and six months ended June 30, 2026 and 2025, and the unaudited condensed statements of cash flows for the six months ended June 30, 2026 and 2025 are unaudited. These unaudited condensed financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments necessary to present fairly the Company’s financial position, results of operations, and cash flows for the interim period presented. The financial data and the other financial information contained in these notes to the unaudited condensed financial statements related to the three and six months ended June 30, 2026 and 2025 are also unaudited. The condensed results of operations for the three and six months ended June 30, 2026 are not necessarily indicative of the results to be expected for the year ending December 31, 2026 or for any other future annual or interim period. Note 2. Summary of Significant Accounting Policies The Company’s significant accounting policies are disclosed in the audited financial statements as of and for the years ended December 31, 2024 and 2025, included in the Company’s final prospectus dated August 7, 2026 related to its IPO filed pursuant to Rule 424(b)(4) under the Securities Act of 1933, as amended. Since the date of those financial statements, there have been no changes to its significant accounting policies, except where noted below. Use of Estimates The preparation of the Company’s unaudited condensed financial statements requires the Company to make estimates and assumptions that impact the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in the unaudited condensed financial statements and accompanying notes. Such estimates include the estimated incremental borrowing rate for the determination of the Company’s operating lease right-of-use assets, valuation of stock-based awards, fair value of common stock prior to the Company's IPO, and the accrual of research and development expenses. Management evaluates its estimates on an ongoing basis. Although estimates are based on the Company’s historical experience, knowledge of current events, and actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions. Common Stock Valuation Due to the absence of an active market for the Company’s common stock, the Company utilized methodologies, approaches and assumptions consistent with the American Institute of Certified Public Accountants’ Audit and Accounting Practice Guide: Valuation of Privately-Held Company Equity Securities Issued as Compensation to estimate the fair value of its common stock prior to its IPO. In determining the exercise prices for options granted, the Company has considered the fair value of the common stock as of the grant date. The estimated fair value of the common stock has been determined based upon a variety of factors, including: • the prices at which the Company sold shares of its convertible preferred stock and the superior rights, preferences and privileges of the convertible preferred stock relative to the Company’s common stock at the time of each grant; • the progress of the Company’s research and development programs; • the Company’s stage of development and its business strategy; • external market conditions affecting the biotechnology industry and trends within the biotechnology industry; • the Company’s financial position, including cash on hand, and its historical and forecasted performance and operating results; • the lack of an active public market for the Company’s common stock and its convertible preferred stock; • the likelihood of achieving a liquidity event, such as an initial public offering or sale of the Company in light of prevailing market conditions; and • the analysis of IPOs and the valuations and market performance of similar companies in the biotechnology industry. Based on the Company’s early stage of development and other relevant factors, options granted prior to February 11, 2026, were valued using an option pricing method (“OPM”) as an OPM was the most appropriate method for allocating the enterprise value to determine the estimated fair value of the common stock. For options granted after February 11, 2026, the Company determined that a 8 hybrid method that combines both OPM and probability-weighted expected return method (“PWERM”) was the most appropriate method to determine the estimated fair value of the Company’s common stock. Significant changes to the key assumptions underlying the factors used could result in different fair values of common stock at each valuation date. Deferred Offering Costs The Company capitalizes costs that are directly associated with in-process equity financings until such financings are consummated, at which time such costs are recorded against the gross proceeds of the offering. Should an in-process equity financing be abandoned, the deferred offering costs will be expensed immediately as a charge to operating expenses in the statements of operations. As of June 30, 2026 , the Company had deferred offering costs of $ 3.0 million, recorded as a component of prepaid expenses and other current assets. There were no deferred offering costs as of December 31, 2025 . Net Loss per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of shares of common stock and common stock equivalents outstanding for the period. The Company has excluded 102,002 and 51,283 weighted-average shares subject to repurchase or forfeiture from the weighted-average number of shares of common stock outstanding for the three and six months ended June 30, 2026, respectively. Common stock equivalents are only included when their effect is dilutive. The Company’s potentially dilutive securities include outstanding convertible preferred stock, as well as outstanding stock options under the Company’s 2020 Equity Incentive Plan. Potentially dilutive securities have been excluded from the computation of diluted net loss per share as their inclusion would be anti-dilutive. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Company’s net loss position. The following table summarizes the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net loss per share because their inclusion in the calculation would be anti-dilutive: Six Months Ended June 30, 2026 2025 Convertible preferred stock 18,258,960 13,485,975 Options to purchase common stock 1,121,232 1,178,288 Common stock subject to repurchase rights 223,098 — Total 19,603,290 14,664,263 Emerging Growth Company Status The Company is an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act (the “JOBS Act”), and may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies. The Company may take advantage of these exemptions up until the last day of the fiscal year following the fifth anniversary of an offering or such earlier time that the Company is no longer an “emerging growth company.” Section 107 of the JOBS Act provides that an “emerging growth company” can take advantage of the extended transition period afforded by the JOBS Act for the implementation of new or revised accounting standards. The Company has elected to use the extended transition period for complying with new or revised accounting standards and as a result of this election, its financial statements may not be comparable to companies that comply with public company effective dates. However, the Company may elect to early adopt any new or revised accounting standards whenever such early adoption is permitted for non-public companies. The Company may take advantage of these exemptions up until the time that it is no longer an emerging growth company. Recently Issued Accounting Pronouncements There were no significant updates not already disclosed in the Company’s audited financial statements for the years ended December 31, 2024 and 2025 to the recently issued accounting standards for the three months ended June 30, 2026 . Although there are 9 several other new accounting pronouncements issued by the FASB, the Company does not believe any of those accounting pronouncements have had or will have a material impact on its financial position or operating results. Note 3. Fair Value Measurements The following tables show the Company’s cash equivalents measured at fair value as of December 31, 2025 and June 30, 2026 (in thousands): June 30, 2026 Level 1 Level 2 Level 3 Total Assets: Cash equivalents Money market funds $ 94,671 $ — $ — $ 94,671 Total $ 94,671 $ — $ — $ 94,671 December 31, 2025 Level 1 Level 2 Level 3 Total Assets: Cash equivalents Money market funds $ 135,227 $ — $ — $ 135,227 Total $ 135,227 $ — $ — $ 135,227 The carrying amounts of the Company’s accounts payable, accrued expenses and accrued compensation approximate fair value due to their short maturities. None of the Company’s non-financial assets or liabilities are measured at fair value on a non-recurring basis. There were no transfers between Levels 1, 2 or 3 for any of the periods presented. Note 4. Accrued Expenses Accrued expenses consisted of the following (in thousands): As of June 30, 2026 As of December 31, 2025 Accrued research and development expenses $ 7,938 $ 8,297 Other 1,256 134 Total accrued expenses $ 9,194 $ 8,431 Note 5. Convertible Preferred Stock and Stockholders’ Deficit Stockholders’ Deficit As of June 30, 2026 , under the Company’s Amended and Restated Certificate of Incorporation, the Company had a total of 195,552,612 shares of capital stock authorized for issuance, consisting of 110,000,000 shares of common stock, par value of $ 0.0001 per share, and 85,552,612 shares of convertible preferred stock, par value of $ 0.0001 per share. Convertible Preferred Stock In 2020, the Company issued 2,134,242 shares of its Series Angel convertible preferred stock at a price of $ 0.94 per share, resulting in aggregate gross proceeds of $ 2.0 million, and incurred immaterial issuance costs. In 2021, the Company issued 5,679,965 shares of its Series A convertible preferred stock at a price of approximately $ 12.50 per share, resulting in aggregate gross proceeds of $ 71.0 million, and incurred immaterial issuance costs. In 2023, 2024 and 2025, the Company issued an aggregate of 10,444,753 shares of Series B convertible preferred stock at a price of $ 17.63 per share resulting in aggregate gross proceeds of $ 184.2 million and incurred $ 0.4 million of total issuance costs. 10 As of June 30, 2026, the Company’s Series Angel, Series A and Series B convertible preferred stock have been classified as temporary equity in the accompanying balance sheets given that the holders of the convertible preferred stock could cause certain events to occur that are outside of the Company’s control whereby the Company could be obligated to redeem the convertible preferred stock. The carrying value of the convertible preferred stock is not adjusted to the redemption value until the contingent redemption events are considered to be probable of occurring. Immediately prior to the closing of the IPO in August 2026, the Company’s outstanding convertible preferred stock automatically converted into 18,258,960 shares of common stock. Following the closing of the IPO, no shares of convertible preferred stock were outstanding. The Company’s convertible preferred stock has the following rights, preferences and privileges: Dividends The Company shall not declare or pay any dividends on shares of any class of capital stock of the Company unless the holders of the Series Angel, Series A or Series B convertible preferred stock shall first receive, or simultaneously receive, a dividend on each outstanding share of such convertible preferred stock equal to an amount as defined in the Company’s Amended and Restated Certificate of Incorporation. No such dividends have been declared or paid through June 30, 2026. Preferences on Liquidation The holders of the Series A and Series B convertible preferred stock are entitled to receive liquidation preferences, in the event of a change in control, liquidation, dissolution or winding up, at an amount per share equal to the greater of (i) the original issuance price, plus any dividends declared but unpaid or (ii) the amount per share that would be payable had the share been converted to shares of common stock immediately prior to the liquidation event. Liquidation payments to the holders of the Series A and Series B convertible preferred stock have priority and are made in preference to any payments to the holders of Series Angel convertible preferred stock and common stock. If assets available to be distributed are insufficient to pay Series A and Series B convertible preferred stockholders, amounts available will be distributed on a pro-rata basis. After full payment of the liquidation preference to the holders of the Series A and Series B convertible preferred stock, the remaining assets, if any, will be distributed to the holders of the Series Angel convertible preferred stock. The holders of the Series Angel convertible preferred stock are entitled to receive liquidation preferences, in the event of a change in control, liquidation, dissolution or winding up, at an amount per share equal to the greater of (i) the original issuance price, plus any dividends declared but unpaid or (ii) the amount per share that would be payable had the share been converted to shares of common stock immediately prior to the liquidation event. Liquidation payments to the holders of the Series Angel convertible preferred stock have priority and are made in preference to any payments to the holders of common stock. If assets available to be distributed are insufficient to pay Series Angel convertible preferred stockholders, amounts available will be distributed on a pro-rata basis. After full payment of the liquidation preference to the holders of the Series Angel, Series A and Series B convertible preferred stock, the remaining assets, if any, will be distributed to the holders of common stock, pro rata based on the number of shares held by each holder. Conversion Rights The shares of Series Angel, Series A and Series B convertible preferred stock are convertible into common stock at the option of the holder. The conversion rate for the convertible preferred stock is determined by dividing the original issue price by the conversion price. The conversion price is initially the original issue price, but is subject to adjustment for dividends, stock splits and other distributions. The conversion rate on June 30, 2026, for the Series Angel, Series A and Series B convertible preferred stock was 1:1. Each share of Series Angel, Series A and Series B convertible preferred stock will be automatically converted into common stock at the then effective conversion rate upon: (i) the closing of the sale of common stock to the public (subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization with respect to the common stock), in a firm-commitment underwritten public offering pursuant to an effective registration statement under the Securities Act of 1933, as amended, resulting in at least $ 50.0 million of gross proceeds to the Company; or (ii) the date and time, or the occurrence of an event, specified by vote or written consent of the majority of holders of the outstanding shares of Series Angel, Series A and Series B convertible preferred stock. 11 Voting The holders of Series Angel convertible preferred stock shall be entitled to cast the number of votes equal to ten times the number of shares of Common Stock into which the shares of Series Angel convertible preferred stock held by such holder are then convertible. The holders of Series A and Series B convertible preferred stock shall be entitled to cast the number of votes equal to the number of shares of common stock into which the shares of Series A and Series B convertible preferred stock held by such holder are then convertible. The holders of Series Angel, Series A and Series B convertible preferred stock generally vote together with the shares of common stock as a single class, but also have class vote approval rights as provided by the Company’s amended and restated certificate of incorporation or as required by applicable law. The holders of shares of Series Angel convertible preferred stock, exclusively and as a separate class, shall be entitled to elect one member of the board of directors. The holders of shares of Series A convertible preferred stock, exclusively and as a separate class, shall be entitled to elect three members of the board of directors. The holders of shares of Series B convertible preferred stock, exclusively and as a separate class, shall be entitled to elect two members of the board of directors. The holders of shares of common stock, exclusively and as a separate class, shall be entitled to elect at least one member of the board of directors. The holders of Series Angel, Series A and Series B convertible preferred stock voting together as a single class, shall be entitled to elect all remaining members of the board of directors. Common Stock The voting, dividend and liquidation rights of the holders of the common stock are subject to, and qualified by, the rights, preferences and privileges of the holders of the Series Angel, Series A and Series B convertible preferred stock. The holders of the common stock are entitled to one vote for each share of common stock held at all meetings of stockholders. Stock Options In June 2020, the Company adopted the 2020 Equity Incentive Plan (the “2020 Plan”). The 2020 Plan provides for the grant of incentive stock options (“ISO”), non-statutory stock options (“NSO”), stock bonus awards and restricted stock awards. A total of 320,137 shares of common stock were initially reserved for issuance under the 2020 Plan. The 2020 Plan was subsequently amended in February 2021, July 2023 and March 2025 to increase the total number of shares available under the 2020 Plan to 691,495 , 1,395,279 , and 1,921,534 , respectively. Options granted under the 2020 Plan are exercisable at various dates as determined upon grant and will expire no more than ten years from their date of grant. The exercise price of each option shall be determined by the board of directors based on the estimated fair value of the Company’s stock on the date of the option grant. The exercise price shall not be less than 100 % of the fair market value of the Company’s common stock at the time the option is granted. The stock option awards generally include service condition vesting terms of four years , with 25 % of the award vesting one year from the vesting commencement date and then ratably over the following 36 months, though some vest over shorter periods, vesting monthly from grant date. A summary of the Company’s stock option activity under the 2020 Plan is as follows: Options Outstanding at December 31, 2025 1,178,288 Granted 386,564 Exercised ( 219,189 ) Forfeited ( 1,333 ) Expired — Outstanding at June 30, 2026 1,344,330 Exercisable at June 30, 2026 525,503 Vested and expected to vest at June 30, 2026 1,344,330 As of December 31, 2025 and June 30, 2026 , the Company recorded receivables for amounts related to option exercises of approximately $ 31 thousand and $ 19 thousand, respectively. These amounts were received subsequent to the respective period end. 12 Stock-based Compensation Expense Stock-based compensation expense recognized for all equity awards has been included in the statements of operations as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Research and development 388 233 629 443 General and administrative 189 21 271 42 Total stock-based compensation expense $ 577 $ 254 $ 900 $ 485 As of June 30, 2026 , the unrecognized compensation cost related to outstanding employee and non-employee options was $ 6.0 million and is expected to be recognized as expense over a weighted-average period of approximately 2.9 years. Early Exercise Liability During the three months ended June 30, 2026, the Company amended certain stock option agreements to permit holders to exercise their stock options prior to vesting. Shares issued upon early exercise that remain unvested are subject to the Company's right to repurchase such shares at the original exercise price upon termination of the holder's service. The Company's repurchase right lapses as the underlying shares vest. The right to repurchase shares that were exercised prior to the time the options have vested generally lapses over the four-year vesting period. As of June 30, 2026, the early exercise liability was approximately $ 2.1 million and is included in other current and noncurrent liabilities and reclassified to equity as the shares vest. For accounting purposes, the early exercise of options is not considered to be a substantive exercise until the underlying awards vest and are not considered to be outstanding until those shares vest. Note 6. Commitments and Contingencies The Company has operating leases for its office and laboratory space in San Diego, California. Rent expense was $ 1.3 million and $ 2.6 million for the three and six months ended June 30, 2026, respectively. Note 7. Segment Information The Company operates and manages its business as one reportable and operating segment, which is the business of designing and developing novel small molecule product candidates. The Company’s chief operating decision maker is its Chief Executive Officer, who assesses performance of the segment based on net loss, which includes evaluating the progress of ongoing clinical trials. The measure of segment assets is reported on the balance sheet as total assets. All long-lived assets are maintained in the United States. The following table contains information on segment profit or loss, including significant segment expenses (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Operating expenses: Research and development expenses BH-30643 $ 8,966 $ 3,827 $ 18,516 $ 5,608 BH-30236 1,967 1,339 3,714 2,388 BH-501284 2,045 61 2,629 61 Other projects 57 645 67 1,652 Non project specific research and development expenses 8,320 6,658 16,330 12,393 General and administrative expenses 3,315 1,573 5,521 3,455 Other income 912 859 2,011 1,835 Net loss $ 23,758 $ 13,244 $ 44,766 $ 23,722 13 Note 8. Subsequent Events For the purposes of the condensed financial statements as of June 30, 2026, and the three and six months then ended, the Company has evaluated the subsequent events through September 18, 2026, the date the condensed financial statements were issued. On July 31, 2026, the Company effected a 1-for-4.6855 reverse stock split of its common stock and convertible preferred stock. The par value and the authorized shares of the common stock and convertible preferred stock were not adjusted as a result of the reverse stock split. These accompanying condensed financial statements and notes to the condensed financial statements give retroactive effect to the reverse stock split for all periods presented. On August 10, 2026, the Company completed its IPO, pursuant to which it issued and sold 9,375,000 shares of common stock at a public offering price of $ 16.00 per share (the “IPO Price” ). The aggregate gross proceeds of the IPO were $ 150.0 million before deducting underwriting discounts, commissions, and offering expenses of $ 15.3 million, for aggregate net proceeds from the IPO of $ 134.7 million. In addition, the Company granted the underwriters an option for a period of 30 days to purchase up to 1,406,250 additional shares of common stock. On August 25, 2026 the underwriters partially exercised their 30-day option and purchased an additional 1,141,240 shares of the Company’s common stock at the IPO Price, upon which the Company received net proceeds of approximately $ 17.0 million. All underwriting discounts, commissions, and offering expenses, including the previously deferred offering costs as disclosed previously in this Quarterly Report, will be charged to additional paid in capital as recorded against the gross proceeds. In connection with the closing of the IPO, the Company’s outstanding convertible preferred stock automatically converted into 18,258,960 shares of common stock. In connection with the closing of the IPO, the Company’s board of directors adopted the 2026 Equity Incentive Plan (the “2026 Plan”), a successor to and continuation of the 2020 Plan (as defined in Note 5), and the 2026 Employee Stock Purchase Plan (the “2026 ESPP”). Upon the effectiveness of the 2026 Plan, 5,280,528 shares of common stock were authorized for issuance which consists of (1) 3,781,612 new shares of common stock, and (2) 1,498,916 shares available for issuance under the 2020 Plan. Furthermore, upon effectiveness of the 2026 Plan, no further grants will be made under the 2020 Plan. Upon the effectiveness of the 2026 ESPP, 302,529 shares of common stock were authorized for issuance. 14 Ite m 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations. The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the financial statements and the related notes and other financial information included elsewhere in this Quarterly Report on Form 10-Q. In addition to historical financial information, the following discussion and analysis contains forward-looking statements based upon current beliefs, plans and expectations that involve risks, uncertainties and assumptions, such as statements regarding our plans, objectives, expectations, intentions and projections. Our actual results and timing of selected events may differ materially from those anticipated in these forward-looking statements as a result of many factors, including those discussed in the section titled “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q. You should carefully read the section titled “Risk Factors” to gain an understanding of the important factors that could cause actual results to differ materially from our forward-looking statements. Please also see the section titled “Special Note Regarding Forward Looking Statements.” Overview We are a clinical-stage biopharmaceutical company applying our intentional, chemistry-based approach to develop innovative small molecule medicines that address significant unmet medical needs in cancer treatment. With each of our programs, we combine a deep understanding of disease and protein dynamics with our structure-based rational drug design expertise to identify the specific structural liabilities that limit existing therapies or approaches, and then design novel chemical scaffolds to directly address these limitations. Our scientific founder and the team we have assembled have a proven track record of developing innovative small molecule medicines that overcome the limitations of existing therapies, including multiple approved therapies that have delivered transformational patient outcomes. Our initial development efforts are focused on our two clinical-stage programs: BH-30643, an investigational, non-covalent, macrocyclic, brain active, mutant-selective OMNI-EGFR inhibitor for the treatment of epidermal growth factor receptor ( EGFR )-mutant non-small cell lung cancer (NSCLC), and BH-30236, an investigational macrocyclic CDC-like kinase (CLK) inhibitor being evaluated first in relapsed or refractory acute myeloid leukemia (R/R AML) and higher-risk myelodysplastic syndromes (HR-MDS). We also have a preclinical-stage product candidate, BH-501284, that leverages a novel chemical scaffold to selectively target and modulate activated KRAS. Our most advanced product candidate, BH-30643, is an OMNI-EGFR inhibitor being evaluated in SOLARA, a global Phase 1/2 clinical trial in patients with EGFR -mutant NSCLC. While there are commercially available drugs targeting EGFR subtypes, there is a fragmentation of care in EGFR -mutant NSCLC because no drug is effective across all EGFR mutations. Moreover, the durability of response to prior-generation EGFR tyrosine kinase inhibitors (TKIs) has frequently been limited by the emergence of acquired on-target resistance mutations, notably the T790M gatekeeper mutation for first- and second-generation EGFR TKIs and C797S-mediated resistance for third-generation EGFR TKIs, such as osimertinib. BH-30643 is designed to address a broad spectrum of EGFR mutations, including classical mutations, on-target resistance mutations such as C797S and T790M, atypical mutations and exon 20 insertion mutations, with selectivity over wild-type EGFR. The SOLARA Phase 1/2 clinical trial is currently enrolling patients across dose expansion cohorts in both TKI-pretreated and TKI-naive settings, including a cohort with C797S resistance, a population with no currently approved targeted therapy, as well as in combination with carboplatin and pemetrexed. In September 2026, we presented updated data from the ongoing Phase 1/2 SOLARA trial in patients with EGFR C797S-positive NSCLC. BH-30643 has demonstrated sub-nanomolar cellular in vitro potency against a broad spectrum of EGFR activating mutations, has been well-tolerated and demonstrated favorable pharmacokinetics in our ongoing SOLARA trial, and has confirmed radiographic responses in patients with EGFR- mutant NSCLC, including with C797S-positive NSCLC (with or without T790M). We believe the early clinical data observed in this trial support a near-term development path in C797S resistance and establish the foundation for BH-30643’s potential against a broad spectrum of EGFR activating mutations. In August 2026, the FDA granted Fast Track designation to BH-30643 for the treatment of adult patients with advanced or metastatic EGFR C797S-positive NSCLC after prior treatment with a third-generation EGFR TKI. An end-of-Phase 1 meeting with the FDA regarding the recommended Phase 2 dose and a potential accelerated approval pathway for BH-30643 in patients with advanced or metastatic EGFR -mutant C797S-positive NSCLC is planned in the fourth quarter of 2026. We expect to dose the first patient in our anticipated pivotal Phase 2 trial in the first quarter of 2027. We plan to report updated Phase 1 data on durability of response in the C797S population in the first half of 2027, initial Phase 1 data on a chemotherapy combination cohort in the second half of 2027, and updated Phase 1 data on durability of response in TKI-naive patients in the second half of 2027. Our second clinical-stage product candidate, BH-30236, is a CLK inhibitor currently being evaluated in an ongoing Phase 1 clinical trial in patients with R/R AML and HR-MDS. BH-30236 represents a novel approach to cancer treatment through the inhibition of CLK to target aberrant alternative mRNA splicing (aberrant alternative splicing), a defining feature implicated in cancer progression and therapeutic resistance across both hematologic malignancies and solid tumors. Our Phase 1 clinical trial is currently enrolling patients in the dose escalation part of the trial and is evaluating BH-30236 as a monotherapy and in combination with the BCL-2 15 inhibitor venetoclax, the established standard of care therapy for AML patients. We also plan to explore the effect of BH-30236 in additional myeloid malignancies, including R/R myelofibrosis, as well as study the safety and antileukemic effect of BH-30236 with venetoclax plus azacitidine for the treatment of AML, with initial studies planned in R/R AML. We expect to report updated data on safety and anti-leukemic effects from the BH-30236 Phase 1 trial in the first half of 2027. We are also advancing our pan-KRAS program, focusing on our preclinical product candidate, BH-501284, which is designed using a novel chemical scaffold to achieve prolonged, potent and selective inhibition of KRAS mutations, but sparing HRAS and NRAS. In preclinical studies, BH-501284 achieved pseudo-irreversible binding characteristics with high binding affinity and a prolonged target residence time exceeding 54 hours, while maintaining high selectivity for KRAS. We are currently conducting Investigational New Drug Application (IND) enabling studies of BH-501284 and plan to submit an IND in the first quarter of 2027. We commenced our operations in 2020 and have devoted substantially all of our resources to date to conducting research and development, staffing our company, establishing and protecting our intellectual property portfolio, scaling up manufacturing processes and supplying our product candidates and other materials for our preclinical studies and clinical trials, leasing office and laboratory space, raising capital, business planning, and providing general and administrative support for these activities. Our operations to date have been funded primarily through the issuance and sale of shares of our convertible preferred stock. From our inception through June 30, 2026, we have raised aggregate gross proceeds of $257.2 million. Additionally, on August 10, 2026, we closed on our IPO, in which we issued and sold 9,375,000 shares of common stock at a public offering price of $16.00 per share. We also sold an additional 1,141,240 shares of common stock upon the partial exercise of the underwriters’ option to purchase additional shares. The aggregate net proceeds of the IPO, inclusive of the partial exercise of the underwriters’ option to purchase additional shares and after deducting underwriting discounts, commissions and offering expenses, was $151.7 million (IPO Proceeds). As of June 30, 2026, we had cash and cash equivalents of $95.4 million. Based on our current operating plan, we estimate that our existing cash and cash equivalents as of June 30, 2026, together with the IPO Proceeds, will be sufficient to fund our projected operating expenses and capital expenditures into the second quarter of 2028. However, this estimate is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. We have based this estimate on assumptions that may prove to be wrong, and we could deplete our capital resources sooner than we expect. Since our inception, we have incurred significant operating losses. Our ability to generate enough product revenue to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our current or future product candidates. Our net losses were $23.8 million and $13.2 million for the three months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $179.8 million. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing and extent of our clinical development activities, other research and development activities and capital expenditures. We expect to continue to incur significant and increasing expenses and operating losses for the foreseeable future as we seek to advance our product candidates through clinical and preclinical development, expand our research and development activities, seek regulatory approval, hire additional personnel and protect our intellectual property. In addition, if we obtain regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product manufacturing, marketing, sales and distribution. We may also incur expenses in connection with the in-licensing or acquisition of additional product candidates. Furthermore, we expect to incur increased expenses related to audit, legal, regulatory and tax-related services associated with maintaining compliance with exchange listing and SEC requirements, director and officer insurance premiums, board of director costs and investor relations costs associated with operating as a public company that we did not incur as a private company. We have never generated any revenue from product sales and do not expect to generate any revenue from product sales unless and until we successfully complete development of and obtain regulatory approval for one or more of our product candidates, which will not be for several years, if ever. Accordingly, until such time as we can generate significant revenue from sales of any of our product candidates, if ever, we expect to finance our cash needs through public or private equity or debt financings or other capital sources, which may include future strategic collaborations and other strategic arrangements with third parties. However, we may not be able to raise additional funds or enter into such other arrangements when needed or on favorable terms, or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through future collaboration or licensing arrangements with third parties or other strategic transactions, we may have to relinquish rights to our intellectual property, future revenue streams, research programs, or product candidates or grant licenses on terms that may not be favorable to us and/or may reduce the value of our common stock. If we are unable to raise additional capital or enter into such arrangements when needed, we could be forced to delay, limit, reduce or terminate our research and development programs or future commercialization efforts, or grant rights to develop and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves. 16 Because of the numerous risks and uncertainties associated with product development, we are unable to 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, we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations. We do not own or operate, and currently have no plans to establish, any manufacturing facilities. We have engaged, and expect to continue to rely on, third-party contract manufacturers to produce and supply our product candidates for use in our preclinical studies and clinical trials. Because we are responsible for ensuring all aspects of our product candidates’ compliance and quality but rely on third-party contract manufacturers and analytical testing laboratories, we must employ personnel with extensive technical, manufacturing, analytical, and quality experience to oversee our contract manufacturing and testing activities, and to compile manufacturing and quality information for our regulatory submissions. We believe our current third-party manufacturers have the scale, systems and experience to supply our currently planned clinical trials. None of our product candidates have been approved for sale. If and when our product candidates receive marketing approval, we intend to commercialize them on our own, or jointly with a partner, in the United States and potentially in other geographies. We plan to continually evaluate the economics of commercializing our product candidates versus other strategic commercialization arrangements. Financial Overview Components of Results of Operations Operating Expenses Our operating expenses consist of (i) research and development expenses and (ii) general and administrative expenses. Research and Development Our research and development expenses consist primarily of external and internal costs related to the discovery and development of product candidates. External costs include: • expenses incurred in connection with the discovery and preclinical development of our product candidates, including under agreements with third parties, such as consultants and CROs; • expenses incurred in connection with conducting clinical trials including investigator grants, site payments, pass-through expenses and expenses incurred under agreements with CROs, central laboratories and other service providers engaged to support the conduct of our trials; • the cost of consultants engaged in research and development related services; • costs related to the outsourced development of CMC processes, scale-up of drug substance manufacturing and procuring our product candidates and other investigational materials for use in our clinical trials and preclinical studies; and • costs related to regulatory compliance and quality assurance. Internal costs include: • personnel-related expenses, including salaries, bonuses, benefits, travel and stock-based compensation expenses for personnel engaged in research and development functions; and • facilities, depreciation, and other expenses, which include allocated expenses for rent and maintenance of facilities, insurance and supplies. We expense research and development costs in the periods in which they are incurred. External expenses are recognized based on an evaluation of the progress to completion of specific tasks using information provided to us by our service providers or our estimate of the level of service that has been performed at each reporting date. Payments made prior to the receipt of goods or services to be used in research and development are recorded as prepaid expenses on the balance sheet until the goods are received or services are performed. We track external research and development costs of specific programs once a specific product candidate has been identified for development. We do not track our internal research and development costs on a program-by-program basis because these costs are associated with multiple programs and, as such, are not separately identified. Research and development activities are central to our business model, and the successful development of our product candidates is highly uncertain. There are numerous factors associated with the approval and successful commercialization of any of our product candidates, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this time based on our stage of development. Potential future changes to regulatory factors beyond our control may impact our 17 development programs. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. In addition, we cannot predict which product candidates may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements. Preclinical and clinical development timelines, the probability of success and total development costs can differ materially from expectations. We anticipate that we will make determinations as to which product candidates and indications to pursue and how much funding to direct to each product candidate on an ongoing basis in response to the results of ongoing and future preclinical studies and clinical trials, regulatory developments, and our ongoing assessments as to each product candidate’s commercial potential. Therefore, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development and commercialization of any of our product candidates or any future product candidates. However, we expect that our research and development expenses will increase substantially as we advance the preclinical and clinical development of our current and potential future product candidates. Our future development costs may vary significantly based on factors, including, but not limited to: • the number and scope of preclinical and IND-enabling studies; • the number of clinical trials required for approval; • the number of sites included in the clinical trials; • the countries in which the trials are conducted; • the length of time required to enroll eligible patients; • the number of patients that participate in the clinical trials; • the number of doses evaluated in the clinical trials; • the costs of manufacturing our product candidates and the costs of procuring any third-party products for use in clinical trials of combination therapies; • the drop-out or discontinuation rates of patients; • potential additional safety monitoring requested by regulatory agencies; • the duration of patient participation in the clinical trials and follow-up; • the phase of development of the product candidate; and • the efficacy, safety and tolerability profile of the product candidate. A change in the outcome of any of these variables may significantly impact the costs and timing associated with the development of our product candidates. General and Administrative General and administrative expenses support our key business functions as we grow and mature as a company. General and administrative expenses consist of personnel-related expenses, including salaries, bonuses, benefits, travel and stock-based compensation expenses for personnel engaged in executive, finance, legal and other administrative functions. Other significant general and administrative expenses include facilities-related costs, legal fees relating to intellectual property and corporate matters, audit costs, information technology-related costs and insurance costs. We expect that our general and administrative expenses will increase substantially for the foreseeable future to support our continued and potentially growing research and development activities, pre-commercial preparation activities for our product candidates, and, if any product candidate receives marketing approval, commercialization activities. Following the closing of the IPO, we also anticipate increased expenses related to audit, legal, regulatory and tax-related services associated with maintaining compliance with exchange listing and SEC requirements, director and officer insurance premiums, board of director costs and investor relations costs associated with operating as a public company. Interest Income, net Interest income, net consists primarily of interest on our cash equivalents held in money market funds. 18 Other Expenses, net Other expenses, net consists primarily of foreign exchange gains and losses. Results of Operations Comparison of the three months ended June 30, 2026 and 2025 The following table summarizes our results of operations for each of the periods indicated (in thousands): Three Months Ended June 30, 2026 2025 Change Operating expenses: Research and development $ 21,355 $ 12,530 8,825 General and administrative 3,315 1,573 1,742 Total operating expenses 24,670 14,103 10,567 Loss from operations (24,670 ) (14,103 ) (10,567 ) Other income (expense), net: Interest income, net 915 859 56 Other expense, net (3 ) - (3 ) Total other income, net 912 859 53 Net loss $ (23,758 ) $ (13,244 ) (10,514 ) Research and Development expenses We track external research and development costs of specific programs once a specific product candidate has been identified for development. We do not track internal research and development costs on a program-by-program basis. The following table summarizes our research and development expenses by program for each of the periods indicated (in thousands): Three Months Ended June 30, 2026 2025 Change External research and development expense: BH-30643 $ 8,966 $ 3,827 $ 5,139 BH-30236 1,967 1,339 628 BH-501284 2,045 61 1,984 Other programs and discovery 998 1,387 (389 ) Internal research and development expense: Personnel-related 5,679 4,911 768 Facilities, overhead and other 1,700 1,005 695 Total research and development expense $ 21,355 $ 12,530 $ 8,825 Research and development expenses were $21.4 million for the three months ended June 30, 2026 compared to $12.5 million for the three months ended June 30, 2025. The increase of $8.8 million was primarily due to increases in both external and internal research and development costs, which are described in more detail below. For BH-30643, external costs were $9.0 million for the three months ended June 30, 2026 compared to $3.8 million for the three months ended June 30, 2025. The increase of approximately $5.1 million was primarily due to significant growth in clinical trial enrollment and sites activated and an increase in manufacturing costs related to the clinical development of BH-30643. For BH-30236, external costs were $2.0 million for the three months ended June 30, 2026 compared to $1.3 million for the three months ended June 30, 2025. The increase of approximately $0.6 million was primarily due to the advancement of our ongoing clinical trial. For BH-501284, external costs were $2.0 million for the three months ended June 30, 2026 compared to $61 thousand for the three months ended June 30, 2025. The increase of $2.0 million was primarily comprised of manufacturing-related expenses to support IND-enabling studies and potential future clinical development. These increases in external research and development costs were partially offset by a decrease of $0.4 million in external expenses related to our other programs and discovery, as we focused investment toward the development of our most advanced product candidates. 19 Internal costs were $7.4 million for the three months ended June 30, 2026 compared to $5.9 million for the three months ended June 30, 2025. The increase of approximately $1.5 million was due to a $0.8 million increase in personnel-related expenses driven by our additional headcount as we expanded the number of research and development employees to support our programs, and an increase of approximately $0.7 million in facilities, overhead and other expenses. General and administrative expenses. General and administrative expenses were $3.3 million for the three months ended June 30, 2026 compared to $1.6 million for the three months ended June 30, 2025. The increase of $1.7 million was comprised of a $0.6 million increase in personnel-related expenses, a $0.7 million increase in legal expenses, and an increase in general overhead and outside services expense of $0.4 million. Interest income, net . Interest income, net was $0.9 million for each of the three months ended June 30, 2026 and 2025. Comparison of the six months ended June 30, 2026 and 2025 The following table summarizes our results of operations for each of the periods indicated (in thousands): Six Months Ended June 30, 2026 2025 Change Operating expenses: Research and development $ 41,256 $ 22,102 19,154 General and administrative 5,521 3,455 2,066 Total operating expenses 46,777 25,557 21,220 Loss from operations (46,777 ) (25,557 ) (21,220 ) Other income (expense), net: Interest income, net 2,017 1,835 182 Other expense, net (6 ) - (6 ) Total other income, net 2,011 1,835 176 Net loss $ (44,766 ) $ (23,722 ) (21,044 ) Research and Development Expenses The following table summarizes our research and development expenses by program for each of the periods indicated (in thousands): Six Months Ended June 30, 2026 2025 Change External research and development expense: BH-30643 $ 18,516 $ 5,608 $ 12,908 BH-30236 3,714 2,388 1,326 BH-501284 2,629 61 2,568 Other programs and discovery 2,009 3,229 (1,220 ) Internal research and development expense: Personnel-related 11,114 9,113 2,001 Facilities, overhead and other 3,274 1,703 1,571 Total research and development expense $ 41,256 $ 22,102 $ 19,154 Research and development expenses were $41.3 million for the six months ended June 30, 2026 compared to $22.1 million for the six months ended June 30, 2025. The increase of $19.2 million was primarily due to increases in both external and internal research and development costs, which are described in more detail below. For BH-30643, external costs were $18.5 million for the six months ended June 30, 2026 compared to $5.6 million for the six months ended June 30, 2025. The increase of approximately $12.9 million was primarily due to significant growth in clinical trial enrollment and sites activated and an increase in manufacturing costs related to the clinical development of BH-30643. For BH-30236, external costs were $3.7 million for the six months ended June 30, 2026 compared to $2.4 million for the six months ended June 30, 2025. The increase of approximately $1.3 million was primarily due to the advancement of our ongoing clinical trial. For BH-501284, external costs were $2.6 million for the six months ended June 30, 2026 compared to $61 thousand for the six months ended June 30, 2025. The increase of $2.6 million was primarily comprised of manufacturing-related expenses to support IND-enabling studies and 20 potential future clinical development. These increases in external research and development costs were partially offset by a decrease of $1.2 million in external expenses related to our other programs and discovery, as we focused investment toward the development of our most advanced product candidates. Internal costs were $14.4 million for the six months ended June 30, 2026 compared to $10.8 million for the six months ended June 30, 2025. The increase of approximately $3.6 million was due to a $2.0 million increase in personnel-related expenses driven by our additional headcount as we expanded the number of research and development employees to support our programs, and an increase of approximately $1.6 million in facilities, overhead and other expenses. General and administrative expenses. General and administrative expenses were $5.5 million for the six months ended June 30, 2026 compared to $3.5 million for the six months ended June 30, 2025. The increase of $2.1 million was comprised of a $1.0 million increase in personnel-related expenses, a $0.5 million increase in legal expenses, and an increase in general overhead and outside services expense of $0.6 million. Interest income, net . Interest income, net was $2.0 million and $1.8 million for the six months ended June 30, 2026 and 2025, respectively. Liquidity and Capital Resources Sources of Liquidity We have incurred net losses and negative cash flows from operations since our inception and expect to continue to incur significant and increasing operating losses for the foreseeable future. We have never generated any revenue from product sales and do not expect to generate any revenue from product sales unless and until we successfully complete development of and obtain regulatory approval for one or more of our product candidates, which will not be for several years, if ever. In addition, if we obtain regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. From our inception through June 30, 2026, we have raised aggregate gross proceeds of $257.2 million to fund our operations, comprised primarily from our issuance of convertible preferred stock. Additionally, in August 2026, we closed on our IPO, in which we received the IPO Proceeds. As of June 30, 2026, we had cash and cash equivalents of $95.4 million and an accumulated deficit of $179.8 million. Based on our current operating plans, we expect the IPO Proceeds, together with our existing cash and cash equivalents, will be sufficient to fund our planned operating expenses and capital expenditure requirements into the second quarter of 2028. Our total future capital requirements will depend on many factors and are subject to the risks and uncertainties set forth in the section titled “Risk Factors.” Cash Flows The following table sets forth a summary of the net cash flow activity for the periods indicated (in thousands): Six Months Ended June 30, 2026 2025 Change Net cash provided by (used in): Operating activities $ (44,174 ) $ (20,121 ) $ (24,053 ) Investing activities (13 ) (997 ) 984 Financing activities 2,881 85 2,796 Net decrease in cash $ (41,306 ) $ (21,033 ) $ (20,273 ) Operating Activities Net cash used in operating activities was $44.2 million and $20.1 million for the six months ended June 30, 2026 and 2025, respectively. The net cash used in operating activities during the six months ended June 30, 2026 consisted primarily of our net loss of $44.8 million, adjusted for $1.9 million in non-cash charges, primarily related to non-cash lease expense, stock-based compensation expense, and depreciation, as well as $1.3 million in net changes in operating assets and liabilities. The net cash used in operating activities during the six months ended June 30, 2025 consisted primarily of our net loss of $23.7 million, adjusted for $1.2 million in non-cash charges, primarily related to non-cash lease expense, stock-based compensation expense, and depreciation, as well as $2.5 million in net changes in operating assets and liabilities. The increase in cash used in operations during the six months ended June 30, 2026 in comparison to the six months ended June 30, 2025 was primarily attributable to increased research and development activities. 21 Investing Activities Net cash used in investing activities was $13 thousand and $1.0 million for the six months ended June 30, 2026 and 2025, respectively, consisting primarily of purchases of property and equipment. Financing Activities Net cash provided by financing activities was $2.9 million and $85 thousand for the six months ended June 30, 2026 and 2025, respectively, consisting of proceeds from the exercise of stock options. Future Funding Requirements As of June 30, 2026, we had cash and cash equivalents of $95.4 million. Based upon our current operating plans, we believe that our existing cash, cash equivalents, and IPO Proceeds will be sufficient to fund our projected operations into the second quarter of 2028. However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. We have based this estimate on assumptions that may prove to be wrong, and we could deplete our capital resources sooner than we expect. Additionally, the process of conducting preclinical studies, manufacturing and testing product candidates in clinical trials is costly, and the timing of progress and expenses in these studies and trials is uncertain. We have incurred significant losses and negative cash flows from operations since our inception. As of June 30, 2026, we had an accumulated deficit of $179.8 million. Our future capital requirements will depend on many factors, including: • the scope, timing, progress, costs and results of discovery, preclinical development, and clinical trials for our current or future product candidates; • the number of clinical trials required for regulatory approval of our current or future product candidates, which may differ between the United States and other countries or regions; • the costs, timing and outcome of regulatory review of any of our current or future product candidates; • the costs associated with potentially acquiring or licensing additional product candidates, technologies or assets, including the timing and amount of any milestones, royalties or other payments due in connection with our acquisitions and licenses; • the cost of manufacturing clinical and commercial supplies of our current or future product candidates; • the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims, including any possible claims by third parties that we are infringing upon their intellectual property rights; • our ability to establish and maintain possible future strategic collaborations or other arrangements and the financial terms of any such agreements, including the timing and amount of any future milestone, royalty or other payments due under any such agreement; • the costs and timing of future commercialization activities, including manufacturing, marketing, sales, and distribution, for any product candidate for which we receive regulatory approval; • the revenue, if any, received from commercial sales of the product candidate(s) for which we receive regulatory approval; • expenses to attract, hire and retain skilled personnel; • the costs of operating as a public company; • our ability to establish a commercially viable pricing structure and obtain approval for coverage and adequate reimbursement from third-party and government payors for any products that receive regulatory approval; • our ability to mitigate the impact of adverse macroeconomic conditions or geopolitical events and conflicts, including any health epidemics and their residual effects, bank failures or inflation and increased interest rates, on our preclinical and clinical development or operations; • the effect of competing technological and market developments; and • the extent to which we acquire or invest in businesses, products and technologies. Until such time, if ever, that we can generate substantial revenue from sales of our product candidates, we expect to finance our cash needs through public or private equity or debt financings or other capital sources, which may include future strategic collaborations 22 and other strategic arrangements with third parties. However, we may not be able to raise additional funds or enter into such other arrangements when needed or on favorable terms, or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through future collaboration or licensing arrangements with third parties or other strategic transactions, we may have to relinquish rights to our intellectual property, future revenue streams, research programs, or product candidates or grant licenses on terms that may not be favorable to us and/or may reduce the value of our common stock. If we are unable to raise additional funds or enter into such arrangements when needed, we could be forced to delay, limit, reduce or terminate our research and development programs or future commercialization efforts, or grant rights to develop and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves. Contractual Obligations and Commitments As part of the capital needs to fund our ongoing operations, our material cash requirements include the following contractual obligations. In June 2024, we entered into a non-cancelable operating lease for office and laboratory space in San Diego, California, with a ten-year initial term through June 2035 (Science Center Lease). The Science Center Lease commenced in June 2025 and includes aggregate monthly rent payments of approximately $0.3 million, with scheduled annual increases in base rent and rent abatements during an initial period of the term. Additionally, we are obligated to pay real estate taxes, maintenance costs, and other operating expenses allocable to the leased premises, which are variable in nature. We paid a cash security deposit of $0.9 million, which is refundable at the end of the lease term and is included in other long-term assets in our balance sheet as of June 30, 2026. As of June 30, 2026, we have future remaining operating lease payments of $38.8 million relating to leases we have recognized in the balance sheet. These obligations are further described in Note 6 to our unaudited condensed financial statements appearing elsewhere in this Quarterly Report. In addition, we enter into agreements and purchase orders in the normal course of business with vendors for the provision of goods and services. These agreements may include certain provisions for termination, with notice, which typically consist of payments for services provided or expenses incurred through the date of cancellation. We believe that our non-cancelable obligations under these agreements are not material. Critical Accounting Estimates Our financial statements are prepared in accordance with generally accepted accounting principles in the United States (GAAP). The preparation of our financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, costs, and expenses and the disclosure of contingent assets and liabilities in our financial statements and accompanying notes. We base our estimates on historical experience, known trends and events, and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and judgments on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions. There have been no significant changes to our critical accounting estimates from those described in Management’s Discussion and Analysis of Financial Condition and Results of Operations - Critical Accounting Policies and Significant Estimates and Judgments and our audited financial statements as of and for the year ended December 31, 2025 as included in the Company’s final prospectus dated August 7, 2026 related to its IPO filed pursuant to Rule 424(b)(4) under the Securities Act of 1933, as amended. Recently Issued Accounting Pronouncements A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 to our audited financial statements and unaudited condensed financial statements included elsewhere in this Quarterly Report. Emerging Growth Company and Smaller Reporting Company Status We are an “emerging growth company” as defined in the JOBS Act, and we may remain an emerging growth company for up to five years following the completion of our initial public offering. For so long as we remain an emerging growth company, we are permitted and intend to rely on certain exemptions from various public company reporting requirements, including not being required to have 23 our internal control over financial reporting audited by our independent registered public accounting firm pursuant to Section 404(b) of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and any golden parachute payments not previously approved. In addition, the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. This provision allows an emerging growth company to delay the adoption of some accounting standards until those standards would otherwise apply to private companies. We have elected to take advantage of the benefits of this extended transition period and, therefore, we are not subject to the same requirements to adopt new or revised accounting standards as other public companies that are not emerging growth companies; however, we may adopt certain new or revised accounting standards early. We would cease to be an emerging growth company upon the earliest to occur of: (i) the last day of the fiscal year in which we have $1.235 billion or more in annual revenue; (ii) the date on which we first qualify as a large accelerated filer under the rules of the SEC; (iii) the date on which we have, in any three-year period, issued more than $1.0 billion in non-convertible debt securities; and (iv) the last day of the fiscal year ending after the fifth anniversary of the completion of our initial public offering. We are also a “smaller reporting company” as defined in the Exchange Act. We may continue to be a smaller reporting company even after we are no longer an emerging growth company. We may take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as the market value of our voting and non-voting common stock held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter, or our annual revenue is less than $100.0 million during the most recently completed fiscal year, and the market value of our voting and non-voting common stock held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter. Ite m 3. Quantitative and Qualitative Disclosures About Market Risk. We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item. Ite m 4. Controls and Procedures. Evaluation of Disclosure Controls and Procedures Our management, with the participation of our principal executive officer and our principal financial officer, evaluated, as of the end of the period covered by this Quarterly Report, the effectiveness of our disclosure controls and procedures. Based on that evaluation, our principal executive officer and principal financial officer concluded that, as of the end of the period covered by this Quarterly Report, our disclosure controls and procedures were effective at the reasonable assurance level. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by such company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports we file or submit under the Exchange Act is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Changes in Internal Control over Financial Reporting There were no changes in our internal control over financial reporting during the quarter ended June 30, 2026, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. 24 PART II—OTHE R INFORMATION Ite m 1. Legal Proceedings. From time to time, we may be involved in legal proceedings arising in the ordinary course of our business. We are not presently a party to any legal proceedings that, in the opinion of management, would have a material adverse effect on our business, financial condition or results of operations. Regardless of outcome, litigation can have an adverse impact on us due to defense and settlement costs, diversion of management resources, negative publicity, reputational harm and other factors. Ite m 1A. Risk Factors Investing in our common stock involves a high degree of risk. You should carefully consider the risks and uncertainties described below, together with all of the other information contained in this Quarterly Report on Form 10-Q, including our financial statements and their related notes included elsewhere in this Quarterly Report on Form 10-Q and the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations”. If any of the following risks actually occurs, our business, prospects, operating results and financial condition could suffer materially, the trading price of our common stock could decline, and you could lose all or part of your investment. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties not presently known to us or that we currently believe to be immaterial also may materially and adversely affect our business, prospects, operating results and financial condition. Risks Related to our Limited Operating History, Financial Position and Need for Additional Capital We are a clinical-stage biopharmaceutical company with a limited operating history. We have not completed any pivotal or late-stage clinical trials and we have no history of commercializing products, which may make it difficult to evaluate our approach to the discovery and development of our product candidates and the prospects for our future viability. We are a clinical-stage biopharmaceutical company with a limited operating history. We were formed in June 2020 and our operations to date have been limited to conducting research and development, staffing our company, establishing and protecting our intellectual property portfolio, scaling up manufacturing processes and supplying our product candidates and other materials for our preclinical studies and clinical trials, leasing office and laboratory space, raising capital, business planning, and providing general and administrative support for these activities. Our initial development efforts are focused on our two clinical-stage programs: BH-30643, an investigational, non-covalent, macrocyclic, brain active, mutant-selective OMNI-EGFR inhibitor for the treatment of EGFR-mutant NSCLC, and BH-30236, an investigational macrocyclic CLK inhibitor being evaluated first in R/R AML and HR-MDS. We are also advancing our pan-KRAS program, initially focusing on our preclinical product candidate, BH-501284, which is designed using a novel chemical scaffold to achieve prolonged, potent and selective inhibition of KRAS mutations. We have not yet demonstrated an ability to successfully complete a clinical program, including large-scale, pivotal clinical trials, obtain regulatory approvals, manufacture a commercial-scale product or arrange for a third party to do so on our behalf, conduct sales and marketing activities necessary for successful product commercialization or generate revenues or arrange for a third party to do so on our behalf. We may encounter unforeseen expenses, difficulties, complications, delays and other known or unknown factors in achieving our business objectives. Accordingly, you should consider our prospects in light of the costs, uncertainties, delays and difficulties frequently encountered by companies in clinical development, especially clinical-stage biopharmaceutical companies such as ours. Any predictions you make about our future success or viability may not be as accurate as they could be if we had a longer operating history or a history of successfully developing and commercializing pharmaceutical products. We have incurred substantial losses since our inception. We anticipate incurring substantial and increasing losses for the foreseeable future and may never achieve or maintain profitability. Investment in pharmaceutical product development is highly speculative because it entails substantial upfront capital expenditures and significant risk that any potential product candidate will fail to demonstrate adequate efficacy or an acceptable safety profile, gain regulatory approval and become commercially viable. For the years ended December 31, 2024 and 2025, our net losses were approximately $30.7 million and $60.6 million, respectively. For the six months ended June 30, 2026, our net loss was $44.8 million. As of June 30, 2026, we had an accumulated deficit of approximately $179.8 million. Substantially all of our losses have resulted from expenses incurred in connection with research and development, preclinical study and clinical trial costs, and from general and administrative costs associated with our operations. We expect to continue to incur significant expenses and additional operating losses for the foreseeable future as we seek to advance our product candidates through preclinical and clinical development, expand our research and development activities, develop new product candidates, conduct clinical trials, seek regulatory approval and, if we receive regulatory approval, commercialize our products. Furthermore, the costs of advancing product candidates into each succeeding clinical phase tend to increase substantially 25 over time. The total costs to advance any of our product candidates to regulatory approval in even a single jurisdiction would be substantial. Because of the numerous risks and uncertainties associated with product development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to generate any revenue from the commercialization of any approved products or achieve or maintain profitability. Our expenses will also increase substantially as we operate as a public company and add clinical, scientific, operational, financial and management information systems and personnel, including personnel to support our product development and potential future commercialization efforts. We have no product candidates approved for commercial sale and have not generated any revenue from the sale of products. Our ability to become and remain profitable depends on our ability to generate revenue. We do not expect to generate significant revenue, if any, unless and until we, either alone or with a collaborator, are able to obtain regulatory approval for, and successfully commercialize, our product candidates for their initial and potential additional indications, or any other product candidates we may develop in the future. Successful commercialization will require achievement of many key milestones, including demonstrating each product candidate’s safety and efficacy in clinical trials, obtaining regulatory approval for these product candidates, manufacturing, marketing and selling those products for which we, or any of our future collaborators, may obtain regulatory approval, satisfying any post-marketing requirements and obtaining reimbursement for our products from private insurance or government payors. Because of the uncertainties and risks associated with these activities, we are unable to accurately and precisely predict the timing and amount of expenses or when, or if, we will be able to generate any revenue, the extent of any further losses, or if or when we might achieve profitability. We and any future collaborators may never succeed in these activities and, even if we do, or any future collaborators do, we may never generate revenues that are large enough for us to achieve profitability. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Additionally, our expenses could increase if we are required by the FDA, or any comparable foreign regulatory authority, to perform clinical trials in addition to those currently expected, or if there are any delays in completing our clinical trials or in the nonclinical or manufacturing-related activities associated with the development of our product candidates. Even if we succeed in obtaining regulatory approvals for and commercializing BH-30643, BH-30236 or any of our other product candidates, we expect to incur substantial development costs and other expenditures to develop and market additional product candidates. We may also encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. The size of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenue or raise additional capital. Our prior losses and expected future losses have had and will continue to have an adverse effect on our stockholders’ equity and our working capital. Our failure to become and remain profitable may depress the market price of our common stock and could impair our ability to raise capital, expand our business, build out our pipeline, or continue our operations. If we continue to suffer losses as we have in the past, you may not receive any return on your investment and may lose your entire investment. We will require substantial additional financing to achieve our goals, which may cause dilution to our stockholders, and failure to obtain additional capital when needed, or on acceptable terms, could cause us to delay, limit, reduce or terminate our product development or future commercialization efforts. The development of pharmaceutical product candidates is capital-intensive. We expect to continue to spend substantial amounts of cash to conduct further research and development, preclinical studies, and clinical trials of our current and any future product candidates, to seek regulatory approvals for our product candidates and to launch and commercialize any products if we receive regulatory approval. Our operations have consumed substantial amounts of cash since our inception. As of June 30, 2026, we had $95.4 million in cash and cash equivalents. In August 2026, we received aggregate net proceeds of approximately $151.7 million from our initial public offering (IPO), inclusive of the partial exercise of the underwriters’ option to purchase additional shares (IPO Proceeds). Based on our current operating plan, we estimate that our existing cash and cash equivalents as of June 30, 2026, together with the IPO Proceeds, will be sufficient to fund our projected operating expenses and capital expenditure requirements into the second quarter of 2028. Our future capital requirements and the period over which our existing resources will support our operations may vary significantly from what we expect, and we will in any event require additional capital in order to complete clinical development of our current programs. Our monthly spending levels will vary based on new and ongoing development and corporate activities. Because the length of time and activities associated with development of our product candidates and programs is highly uncertain, we are unable to estimate the actual funds we will require for development and any approved marketing and future commercialization activities, if any. Our future capital requirements will depend on many factors, including: • the scope, timing, progress, costs and results of discovery, preclinical development, and clinical trials for our current or future product candidates; • the number of clinical trials required for regulatory approval of our current or future product candidates, which may differ between the United States and other countries or regions; 26 • the costs, timing and outcome of regulatory review of any of our current or future product candidates; • the costs associated with potentially acquiring or licensing additional product candidates, technologies or assets, including the timing and amount of any milestones, royalties or other payments due in connection with our acquisitions and licenses; • the cost of manufacturing clinical and commercial supplies of our current or future product candidates; • the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims, including any possible claims by third parties that we are infringing upon their intellectual property rights; • our ability to establish and maintain possible future strategic collaborations or other arrangements and the financial terms of any such agreements, including the timing and amount of any future milestone, royalty or other payments due under any such agreement; • the costs and timing of future commercialization activities, including manufacturing, marketing, sales, and distribution, for any product candidate for which we receive regulatory approval; • the revenue, if any, received from commercial sales of the product candidate(s) for which we receive regulatory approval; • expenses to attract, hire and retain skilled personnel; • the costs of operating as a public company; • our ability to establish a commercially viable pricing structure and obtain approval for coverage and adequate reimbursement from third-party and government payors for any products that receive regulatory approval; • our ability to mitigate the impact of adverse macroeconomic conditions or geopolitical events and conflicts, including any health epidemics and their residual effects, bank failures or inflation and increased interest rates, on our preclinical and clinical development or operations; • the effect of competing technological and market developments; and • the extent to which we acquire or invest in businesses, products and technologies. We will require substantial additional capital to achieve our business objectives, which we may raise through public or private equity offerings, debt financings or other capital sources, including strategic collaborations, licenses and other similar arrangements to enable us to complete the development and potential commercialization of our product candidates. Additional funds may not be available on a timely basis, on favorable terms or at all, and such funds, if raised, may not be sufficient to enable us to continue to implement our long-term business strategy. Additionally, if we raise additional funds through future collaborations, licenses and other similar arrangements, we may have to relinquish valuable rights to our future revenue streams or product candidates or grant licenses on terms that may not be favorable to us and/or that may reduce the value of our common stock. Market volatility resulting from potential negative global economic conditions and disruptions in the United States and international credit and financial markets including due to geopolitical conflicts, tariffs, other fiscal and trade policy changes, bank failures, supply chain and labor disruptions, the effects of a health epidemic or pandemic or other factors may further adversely impact our ability to access capital as and when needed. Our failure to raise capital as and when needed would have a negative effect on our financial condition and our ability to pursue our business strategy. In addition, attempting to secure additional financing may divert the time and attention of our management from day-to-day activities and harm our development efforts. In addition, we may seek additional capital due to favorable market conditions or strategic considerations, even if we believe we have sufficient funds for our current or future operating plans. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a holder of our common stock. Any future debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, selling or licensing our assets, making capital expenditures, declaring dividends or encumbering our assets to secure future indebtedness. Such restrictions could adversely impact our ability to conduct our operations and execute our business plan. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed or on terms acceptable to us, we would be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves. Risks Related to the Discovery, Development and Regulatory Approval of our Product Candidates Our discovery and development programs are focused in part on precision medicines for patients with genetically defined cancers, which is a rapidly evolving and scientifically uncertain field, and our scientific approach, including with respect to BH-30643 and BH-30236, may never lead to marketable products. 27 The discovery and development of precision medicines for patients with genetically defined cancers is an emerging field, and the scientific discoveries that form the basis for our efforts to discover and develop product candidates are relatively new. The scientific evidence to support the feasibility of developing product candidates based on these discoveries is both preliminary and limited. Although we believe, based on our preclinical work and preliminary clinical trial results, that the mutations targeted by certain of our programs are oncogenic drivers, future clinical results may not confirm this hypothesis, or may only confirm it for certain mutations or certain tumor types. The patient populations for certain of our product candidates are limited to those with specific target mutations and may not be completely defined, but are substantially smaller than the general treated cancer population. We may need to screen and identify these patients with the targeted mutations, and successful identification is dependent on several factors, including achieving certainty as to how specific genetic alterations respond to our product candidates and developing companion diagnostics to identify such genetic alterations. Even if we are successful in identifying patients, we cannot be certain that the resulting patient populations for each targeted mutation will be sufficient to allow us to successfully complete clinical trials and obtain approval for each targeted mutation type or, if approved, to successfully commercialize our product candidates and achieve profitability. In addition, our scientific approach to design novel chemical scaffolds to overcome specific structural liabilities that limit existing therapies or approaches may not be successful in addressing these limitations or creating product candidates that ultimately succeed in development, regulatory approval or commercialization. Even if our approach demonstrates clinical benefit for tumors harboring the targeted mutations that drive the diseases for which we are developing our product candidates, we may never successfully identify additional oncogenic mutations sufficient to obtain regulatory approvals with respect to such mutations. In addition, the heterogeneity of the tumor resistance environment our clinical product candidates are targeting heightens the risk around attempting to overcome both on- and off- target tumor resistance. We may also be unsuccessful in using our approach to identify additional product candidates, and any of our product candidates may be shown to have harmful side effects or other characteristics that necessitate additional clinical testing or make them unmarketable or unlikely to receive or maintain regulatory approval. In particular, any failure of one of our development programs—or a competitor’s product or program pursuing a similar approach—could create a perception that our other programs are less likely to succeed or that our overall approach is not viable. We believe we have had favorable preclinical study and early clinical trial results; however, we are early in our development efforts, including with respect to BH-30643 and BH-30236, and may not succeed in demonstrating the efficacy and safety of any product candidate in clinical trials or in obtaining regulatory approval thereafter. We also cannot be certain that our scientific and development approach, including with respect to BH-30643 and BH-30236, will result in an approvable or marketable product with commercial value in our initial targeted indications or any other indication. Further, the pharmaceutical industry is characterized by rapidly advancing technologies, and our future success will depend in part on our ability to maintain a competitive position. If we fail to stay at the forefront of technological change, we may be unable to compete effectively. Our competitors may render our approach obsolete or limit the commercial value of our scientific approach or product candidates through advances in existing technologies or the development of new or different approaches. Conversely, adverse developments with respect to other companies pursuing a similar approach may adversely impact the actual or perceived value of our approach and the potential of our product candidates. Therefore, we do not know whether our approach, including development of product candidates in genetically defined cancers, will be successful, or whether our specific development programs for BH-30643 and BH-30236 will yield approvable or commercially viable products. If our approach or our individual programs are unsuccessful, the value of our company could decline significantly. We are early in our development efforts and only have two product candidates, BH-30643 and BH-30236, in early clinical development. Our pan-KRAS product candidate, BH-501284, is in the preclinical stage. If we are unable to continue to advance our product candidates through or into clinical development, obtain regulatory approval and ultimately commercialize our product candidates or we experience significant delays in doing so, our business will be materially harmed. We are in the early stages of our development efforts and are substantially dependent on the success of our product candidates, BH-30643 and BH-30236, which are in early clinical development. Our pan-KRAS product candidate BH-501284 is in the preclinical stage. We will need to progress BH-30643 and BH-30236 through our ongoing and planned clinical trials and progress BH-501284 and any future development program through preclinical studies and submit INDs to the FDA or comparable foreign regulatory applications to applicable foreign regulatory authorities prior to initiating their clinical development. We will also need to submit INDs or comparable foreign regulatory applications prior to expanding development of our product candidates beyond our initial development focus into other distinct patient populations. Our ability to generate product revenues, which we do not expect will occur for several years, if ever, will depend heavily on the successful development and eventual successful commercialization of our product candidates. The success of our product candidates will depend on several factors, including the following: • completion of preclinical studies with favorable results; 28 • successful enrollment in, and completion of, clinical trials with favorable results; • sufficiency of our financial and other resources to complete necessary preclinical studies and clinical trials; • allowance to proceed with clinical trials under INDs by the FDA or under similar regulatory submissions by applicable foreign regulatory authorities for the conduct of clinical trials of our product candidates and our proposed design of future clinical trials; • demonstrating the safety and efficacy of our product candidates to the satisfaction of the FDA and other applicable foreign regulatory authorities; • receipt of regulatory approvals from applicable regulatory authorities, including new drug applications (NDAs) from the FDA and approvals from comparable foreign regulatory authorities and maintaining such approvals; • making arrangements with third-party manufacturers, to manufacture sufficient quantities of product candidates for clinical and potential commercial use; • establishing sales, marketing and distribution capabilities and launching commercial sales of our products, if and when approved, whether alone or in collaboration with others; • acceptance of any products we develop and their benefits and uses, if and when approved, by patients, the medical community and third-party payors; • establishing and maintaining intellectual property protection, including patent and trade secret protection, or regulatory exclusivity for our product candidates; • effectively competing with other approved therapies or therapies that may be approved in the future; • obtaining and maintaining healthcare coverage and adequate reimbursement from third-party payors; • maintaining an acceptable safety profile of our products following approval; and • building and maintaining an organization of people who can successfully develop our product candidates. We have not yet succeeded and may not succeed in demonstrating efficacy and safety for any product candidates in clinical trials or in obtaining regulatory approval thereafter. Given our early stage of development, it will take several years before we can demonstrate the safety and efficacy of a product candidate sufficient to warrant regulatory approval for commercialization, if we can do so at all. If we are unable to develop, or obtain regulatory approval for, or, if approved, successfully commercialize, our product candidates, we may not be able to generate sufficient revenue, or any revenue at all, to continue our business. Preclinical and clinical development involves a lengthy and expensive process, with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial or real-world results. Our product candidates may not have favorable results in preclinical studies or clinical trials or receive regulatory approval on a timely basis, if at all. BH-30643 and BH-30236 are in clinical development and their risk of failure is high. It is impossible to predict when or if our product candidates will receive regulatory approval. To obtain the requisite regulatory approvals to commercialize our product candidates, we must demonstrate through lengthy, complex and expensive clinical trials that our product candidates are safe and effective in patient populations for the intended indication(s) for use. Preclinical studies and clinical trials can take many years to complete, and their outcomes are inherently uncertain. Failure can occur at any time during the preclinical study or clinical trial process, despite promising preclinical or clinical results. The results of preclinical studies and early clinical trials of our product candidates may not be predictive of the results of later-stage clinical trials, and results in one indication may not be predictive of results to be expected for the same product candidates in another indication. Differences in trial design between early-stage clinical trials and later-stage clinical trials make it difficult to extrapolate the results of earlier clinical trials to later clinical trials. A number of companies in the pharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or unfavorable safety profiles, notwithstanding promising results in earlier trials. Such setbacks have occurred and may occur for many reasons, including, but not limited to: clinical sites and investigators may deviate from clinical trial protocols, whether due to lack of training or otherwise, and we may fail to detect any such deviations in a timely manner; patients may fail to adhere to any required clinical trial procedures, including any requirements for post-treatment follow-up; our product candidates may fail to demonstrate effectiveness or safety in certain patient subpopulations, or even in the target patient population, which has not been observed in earlier trials due to limited sample size, lack of analysis, or otherwise; or our clinical trials may not adequately represent the patient populations we intend to treat, whether due to limitations in our trial designs or otherwise, such as where one patient subgroup is overrepresented in the clinical trial. We may be unable to establish clinical endpoints that applicable regulatory authorities would consider clinically meaningful. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates achieved promising results have nonetheless failed to obtain regulatory approval of such product candidates or, upon commercialization, achieve or maintain positive real-world results. 29 Furthermore, because our clinical trials for BH-30643 and BH-30236 are conducted primarily in patients with advanced disease whose prior therapies have not been effective, or have failed due to resistance, including resistance mutations and resistance due to biological mechanisms partially related or unrelated to their prior therapies, patients may experience disease progression independent from our product candidates, which may make them unevaluable for purposes of the clinical trial and may require additional patient enrollment. For example, certain patients enrolled in the C797S resistance cohort of our SOLARA trial of BH-30643 have progressed following treatment with a third-generation EGFR TKI, representing a population for whom prior targeted therapy has already failed. Similarly, patients enrolled in our Phase 1 clinical trial of BH-30236 have R/R AML or HR-MDS, representing a population for whom prior treatments have not been effective or on which patients have relapsed. Because we are conducting trials in patients who are already sick and for whom prior treatments have not been effective, the clinical activity and tolerability results we observe may not be representative of what could be observed in patients earlier in the treatment continuum, including patients with less advanced disease or who have not yet been exposed to prior therapies. Inclusion of patients with significant co-morbidities in our clinical trials may also result in deaths or other adverse medical events due to an underlying condition or other therapies or medications that such patients may be using, which could prevent us from obtaining regulatory approval or, if approved, achieving or maintaining market acceptance. Additionally, development risks may be heightened for targeted indications (such as C797S-positive NSCLC) or treatment mechanisms (such as CLK inhibition for BH-30236) where no approved targeted therapies currently exist, as there is limited regulatory and clinical precedent to guide development. We will also face distinct risks in target indications where established standards of care or competing approved therapies already exist, including in first-line NSCLC where osimertinib and other approved therapies are well-established standards of care. Clinical trials designed to support approval in earlier-line settings are likely to require randomized controlled designs with active comparator arms and primary endpoints based on progression-free or overall survival, rather than the ORR endpoints that may support approval in later-line settings with no approved alternative therapies. The probability of clinical success in these trials may be materially lower than in our initial indications, where the absence of approved targeted therapies provides a more favorable regulatory and clinical benchmark. Future expansion of our development programs into additional hematologic malignancies and/or solid tumors and commencing any future clinical trials, including for BH-501284, is subject to finalizing the clinical trial protocol and submitting an IND to the FDA or a similar application to a comparable foreign regulatory authority to initiate a clinical trial. Even after we make our submission, the FDA or comparable foreign regulatory authorities could disagree that we have satisfied their requirements to commence our clinical trials in the manner we propose or disagree with our trial design, which may require us to complete additional preclinical studies or amend our protocols or impose stricter conditions on the commencement of clinical trials, which may lead to delays and increase the costs of our preclinical development programs. Most product candidates that commence clinical trials are never approved as commercial products and there can be no assurance that any of our current or future clinical trials will ultimately be successful or support the approval of our current or any future product candidates. We may experience delays in initiating or completing clinical trials or reporting data readouts for such trials, due to unforeseen events or otherwise, that could delay or prevent our ability to receive regulatory approval or commercialize our current and any future product candidates, including: • regulators, such as the FDA or comparable foreign regulatory authorities, Institutional Review Boards (IRBs) or ethics committees may impose additional requirements before permitting us to initiate a clinical trial, may not authorize us or our investigators to commence or conduct a clinical trial at a prospective trial site, may not allow us to amend trial protocols or regulators may disagree as to the design or implementation of our clinical trials and require that we modify or amend our clinical trial protocols or statistical analysis plans; • we may experience delays in reaching, or fail to reach, agreement on acceptable terms with contract research organizations (CROs) or with individual clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among trial sites; • delays in identifying, recruiting and training suitable clinical investigators; • IRBs refusing to approve, suspending or terminating the trial at an investigational site, precluding enrollment of additional patients or withdrawing their approval of the trial; • changes or amendments to the clinical trial protocol; • clinical trial sites may deviate from the trial protocol, fail to ensure the integrity of the data being collected at the site or drop out of a trial; • failure by any of our third-party contractors to perform in accordance with good clinical practices (GCP) requirements or applicable regulatory rules and guidelines in other countries; 30 • the number of patients required for clinical trials may be larger than we anticipate, we may experience difficulty in finding and enrolling sufficient qualified patients for our trials, enrollment in clinical trials may be slower than we anticipate, prospective patients may fail to qualify for enrollment into our clinical trials or patients may drop out or fail to return for post-treatment follow-up at a higher rate than we anticipate; • patients may fail to enroll or remain in our trials at the rate we expect, or fail to return for post-treatment follow-up, including patients failing to remain in our trials due to movement; • patients choosing an alternative product for the indications for which we are developing our product candidates, or participating in competing clinical trials; • the cost of clinical trials may be greater than we anticipate; • the quality or quantity of data relating to our product candidates or other materials necessary to conduct our clinical trials may be inadequate to initiate or complete a given clinical trial; • we may experience difficulties in manufacturing, or fail to manufacture, sufficient quantities of our product candidates for use in clinical trials; • patients experiencing severe or serious unexpected drug-related adverse effects; • reports from clinical testing conducted by other companies of other therapies in the same class of agents that could be considered similar to our product candidates may raise safety, tolerability or efficacy concerns about our product candidates; • we may lack adequate funding to initiate or continue one or more of our clinical trials; • selection of clinical endpoints that require prolonged periods of clinical observation or extended analysis of the resulting data; • a facility manufacturing our product candidates or any of their components being ordered by the FDA or comparable foreign regulatory authorities to temporarily or permanently suspend production due to violations of current Good Manufacturing Practice (cGMP) regulations or other applicable requirements or cross-contaminations of product candidates in the manufacturing process; • changes to our manufacturing processes may be necessary or desired; • third-party contractors being unwilling or unable to satisfy their contractual obligations to us in a timely or accurate manner; • third-party contractors could become debarred or suspended or otherwise penalized by the FDA or other government or regulatory authorities for violations of regulatory requirements, in which case we may need to find a substitute contractor, and we may not be able to use some or all of the data produced by such contractors in support of our planned marketing applications; and • clinical trials of our product candidates may fail to show appropriate safety, tolerability or efficacy, may produce negative or inconclusive results or may otherwise fail to improve on the existing standard of care, and we may decide, or regulators may require us, to conduct additional clinical trials or we may decide to abandon product development programs. We may, in the future, conduct preclinical research and clinical trials in collaboration with other academic, pharmaceutical or biotechnology entities in which we combine our development efforts with those of prospective future collaborators. Such collaborations, if any, may be subject to additional delays because of the management of preclinical research and clinical trials, contract negotiations and the need to obtain agreement from multiple parties, which may increase our future costs and expenses. Clinical trials must be conducted in accordance with the FDA and other applicable regulatory authorities’ legal requirements, regulations and guidelines, and remain subject to oversight by these governmental agencies as well as ethics committees or IRBs responsible for overseeing the conduct of clinical trials and ensuring the welfare of the patients participating in clinical trials of our product candidates. We could encounter delays if a clinical trial is suspended or terminated by us, our potential future collaborators, the IRBs of the institutions at which such trials are being conducted, the FDA or comparable foreign regulatory authorities or the Data Safety Monitoring Board for such trial. A suspension or termination may be imposed due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical trial protocols, adverse findings from inspection of the clinical trial operations or trial site by the FDA or comparable foreign regulatory authorities, unforeseen safety issues or adverse side effects, failure to establish or achieve clinically meaningful clinical trial endpoints, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial. In addition, changes in regulatory requirements and policies may occur, and we may need to amend clinical trial protocols to comply with these changes. Amendments may require us to resubmit our clinical trial protocols to regulators or to IRBs for reexamination, which may impact the costs, timing or successful completion of a clinical trial. Clinical trials may also be delayed or terminated as a result of ambiguous or negative interim results. Many of the factors that cause, or lead to, a delay in the commencement or completion of, or the termination or suspension of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates. Further, the FDA may disagree with our 31 interpretation of data from clinical trials or may change the requirements for approval even after it has reviewed and commented on the design for our clinical trials. Our product development costs will increase if we experience delays in clinical testing or in seeking regulatory approvals. We do not know whether any of our clinical trials will begin as planned, will need to be redesigned or will be completed on schedule, or at all. Significant clinical trial delays could also shorten any periods during which we may have the exclusive right to commercialize our product candidates and may allow our competitors to bring products to market either before we do or in a short time-frame after we do, potentially impairing our ability to successfully commercialize our product candidates, if approved. Any delays or increase in costs in our clinical development programs may harm our business, financial condition, results of operations and prospects. We may find it difficult to enroll patients in our clinical trials. If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected. Patient enrollment is a significant factor in the timing and success of clinical trials, and the timing of our clinical trials depends, in part, on the speed at which we can recruit and enroll patients to participate in our trials, as well as their completion of required follow-up periods. We may not be able to initiate or continue clinical trials for our product candidates if we are unable to identify and enroll a sufficient number of eligible patients to participate in these trials to such trial’s conclusion as required by the FDA or comparable foreign regulatory authorities. In particular, because some of our product candidate development plans are focused on patients with specific genetic mutations, our ability to enroll eligible patients may be limited or may result in slower enrollment than we anticipate. For example, with respect to BH-30643, we cannot be certain how many patients will have each of the genetic mutations that BH-30643 is designed to target or that the number of patients enrolled for each mutation will suffice to obtain regulatory approval for the targeted patient subset. Patient enrollment is affected by many factors including the size and nature of the patient population, competing clinical trials in the same or similar indications or at the same trial site, the severity of the disease or condition under investigation, the availability and efficacy of approved drugs and diagnostics for the disease or condition under investigation, the number and location of clinical sites, the proximity of patients to clinical sites, willingness of patients to participate in a decentralized clinical trial that may involve remote monitoring technologies, the inclusion and exclusion criteria for the trial, perceived risks and benefits of the product candidate under study, the design of the clinical trial, continued enrollment of prospective patients by clinical trial sites, the risk that enrolled patients will not complete a clinical trial, our ability to recruit clinical trial investigators with the appropriate competencies and experience, efforts to facilitate timely enrollment in clinical trials, patient referral practices of physicians, the ability to monitor patients adequately during and after treatment, competing clinical trials and clinicians’ and patients’ perceptions as to the potential advantages and risks of the product candidate being studied in relation to other available therapies, including any new products that may be approved for, or any product candidates under investigation for, the indications we are investigating. Clinical trial recruitment and enrollment activities may also be delayed as a result of macro-factors such as public health emergencies or pandemics, natural disasters and acts of terror or war. Even if we are able to enroll a sufficient number of patients in our clinical trials, we may have difficulty maintaining enrollment of such patients, and delays in enrollment or patients dropping out early in our clinical trials may result in increased costs or may affect the timing or outcome of our clinical trials. Any of these conditions may negatively impact our ability to complete such trials or include results from such trials in regulatory submissions, which could adversely affect our ability to advance the development of our product candidates. Further, other pharmaceutical or biotechnology companies targeting these same diseases may be recruiting clinical trial patients from similar patient populations, which may make it more difficult to fully enroll our clinical trials. Our inability to enroll a sufficient number of patients for any of our clinical trials would result in significant delays or may require us to abandon one or more clinical trials altogether. In addition, we rely on clinical trial sites to ensure proper and timely conduct of our clinical trials and, while we enter into agreements governing their services, we have limited influence over their actual performance. We cannot assure you that our assumptions used in determining expected clinical trial timelines are correct or that we will not experience delays in enrollment, which would result in the delay of completion of such trials beyond our expected timelines. Use of our product candidates could be associated with adverse side effects, adverse events or other safety risks, which could delay or preclude the candidate’s approval, cause us to suspend or discontinue clinical trials, cause us to abandon the product candidates, limit the commercial profile of any future approved product or result in other significant negative consequences that could severely harm our business, prospects, operating results and financial condition. Results of our clinical trials could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics related to our product candidates. Undesirable side effects caused by our product candidates could cause us, the IRB or regulatory authorities to interrupt, delay or halt clinical trials or cause the delay or denial of regulatory approval by the FDA or comparable foreign regulatory authorities, or, if such product candidate is approved, result in a more restrictive label and other post-approval requirements. Any treatment-related side effects could also affect patient recruitment or the ability of enrolled patients to complete the 32 trial or could result in potential product liability claims. Any of these occurrences may harm our business, financial condition, and prospects significantly. If our product candidates are associated with undesirable side effects or have unexpected characteristics in clinical trials, we may need to interrupt, delay or abandon their development or limit development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective. Patients in our ongoing and planned clinical trials have and in the future could suffer significant adverse events or other side effects whether or not observed in our preclinical studies or ongoing or previous clinical trials. For example, in our ongoing SOLARA Phase 1/2 clinical trial of BH-30643, treatment-related adverse events (TRAEs) were observed, including instances of high-grade EGFR wild-type toxicity (mucositis, rash, diarrhea), liver function test abnormalities (bilirubin, ALT, AST) and pneumonitis. In our ongoing Phase 1 trial of BH-30236, TRAEs were observed, including instances of high-grade diarrhea and grade 2 differentiation syndrome. In addition, we have and plan to continue to study our product candidates in combination with other therapies, which may exacerbate adverse events associated with such product candidates. For example, in our ongoing combination dose escalation of BH-30236 with venetoclax, TRAEs, including diarrhea, nausea, vomiting, decreased neutrophil count, decreased platelet count and decreased white blood cell count, were observed in the venetoclax combination arm. Further, patients treated with our product candidates may also be undergoing surgical, radiation and chemotherapy treatments, which can cause side effects or adverse events that are unrelated to our product candidates but may still impact the success of our clinical trials. The inclusion of critically ill patients in our clinical trials may