BMEA 10-K & 10-Q changes, risk factors and insider trading

We have a limited operating history, limited experience in conducting clinical trials, have not completed anythe clinical trials,development of any product candidates, have no products approved for commercial sale, and have not generated any revenue, which may make it difficult for you to evaluate our current business and likelihood of success and viability.

We are a clinical-stage biotechnology company with a limited operating history with which investors can evaluate our business and prospects. We commenced operations in August 2017, have not completed anythe clinical trials,development of any product candidates, have no products approved for commercial sale and have never generated any revenue, and our operations to date have been primarily limited to organizing and staffing our company, business planning, raising capital, conducting discovery and research activities, filing patent applications, identifying potential product candidates, undertaking preclinical studies, preparing for and initiating our initial clinical trials, and establishing arrangements with third parties for the manufacture of initial quantities of product candidates. WeOur currently have twolead product candidates,candidate, icovamenibicovamenib, andis BMF-500,currently under investigation in Phase II clinical trials,trials within type 2 diabetes. In September 2025, we announced that we received IND clearance from the firstFDA patientfor dosedBMF-650, withand BMF-500initiated our ongoing Phase I trial in Octoberobese, 2023.otherwise Ourhealthy remainingvolunteers. productIn candidates,January 2025, we announced that we plan to conclude our studies exploring icovamenib’s potential in oncology and explore partnerships to further advance our oncology assets, including BMF-650, are in the discovery or preclinical development stage.BMF-500.

Investment in biopharmaceutical product development is a highly speculative undertaking and 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. We are early in our development efforts and have not yet completed the development of any of our product candidates. We have no products approved for commercial sale and have not generated any revenue from product sales to date, and we continue to incur significant research and development and other expenses related to our ongoing operations. Even if we succeed in receiving marketing approval for and commercializing one or more of our product candidates, we expect that we will continue to incur substantial research and development and other expenses in order to discover, develop and market additional potential products. We have financed our operations primarily through sales of our common stockstock, warrants and convertible preferred stock.

continue the clinical development of icovamenib for the treatment of patients with type 1 and type 2 diabetes;

continue the preclinical development and initiateconduct clinical development of BMF-650;

Our ability to become profitable depends upon our ability to generate revenue. We have not received marketing approval for any product candidate, and we have not generated any revenue from any product sales or other sources since our inception. We do not expect to generate revenue unless or until we successfully complete preclinical and clinical development and obtain regulatory approval of, and then successfully commercialize, at least one product candidate. Icovamenib, our lead product candidate, is advancing in the early stages of clinical development. As such, we face significant translational risk as our product candidates advance further in clinical development, and promising results in preclinical studies or early clinical trials may not be replicated in later-stage clinical trials. If approved, Icovamenibicovamenib is not intended as a chronic therapy for insulin deficient diabetes, which could further limit our ability to achieve profitability. All of our current and future product candidates will require preclinical and clinical development, regulatory review and approval, substantial investment, access to sufficient commercial manufacturing capacity, and significant marketing efforts before we can generate any revenue from product sales. Our ability to generate revenue depends on a number of factors, including, but not limited to:

timely initiation and completion of our preclinical studies and clinical trials for icovamenib, BMF-500, BMF-650 and our future product candidates, which may be significantly slower or cost more than we currently anticipate and will depend substantially upon the performance of third-party contractors;

establishing and maintaining relationships with contract research organizations (CROs) and clinical sites for the ongoing clinical and preclinical development of icovamenib andicovamenib, BMF-650 and any future product candidates;

our ability to complete IND-enabling studies,studies and successfully submit and receive authorization to proceed under INDs or comparable regulatory applications;

our ability to demonstrate to the satisfaction of the FDA and comparable foreign regulatory authorities the safety, efficacy, consistent manufacturing quality, and acceptable risk-benefit profile of our novel small molecule product candidates or any future product candidates;

We are currently focused on the discovery and development of novel covalent small molecules to treat patients with diabetes and obesity. We seek to maintain a process of prioritization and resource allocation among our programs to maintain a balance between advancing our current product candidates and any future product candidates. Although we had previously pursued the development of icovamenib in cancer and metabolic diseases, in January 2025, we announced that our strategic focus for icovamenib will be in metabolic disorders and that we will conclude our studies exploring icovamenib’sBMF-500’s potential in oncology and explore partnerships to advance our oncology assets.

Actual events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions, transactional counterparties or other companies in the financial services industry or the financial services industry generally, or concerns or rumors about any events of these kinds or other similar risks, have in the pastpast, such as in the case of the closure and subsequent placement into receivership with the Federal Deposit Insurance Corporation (FDIC) of Silicon Valley Bank (SVB) in March 2023, and may in the future lead to market-wide liquidity problems. ForIn example,these on March 10, 2023, Silicon Valley Bank (SVB) was closed by the California Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance Corporation (“FDIC”) as receiver. Similarly, on March 12, 2023, Signature Bank and Silvergate Capital Corp. were each swept into receivership. Although a statement by the Department of the Treasury, the Federal Reserve and the FDIC indicated that all depositors of SVB would have access to all of their money after only one business day of closure, including funds held in uninsured deposit accounts,cases, borrowers under credit agreements, letters of credit and certain other financial instruments with SVB, Signature Bank or any other financial institution that is placed into receivership by the FDIC may be unable to access undrawn amounts thereunder. If any of our suppliers or other parties with whom we conduct business are unable to access funds pursuant to such instruments or lending arrangements with such a financial institution, such parties’ ability to pay their obligations to us or to enter into new commercial arrangements requiring additional payments to us could be adversely affected. In this regard, counterparties to SVB credit agreements and arrangements, and third parties such as beneficiaries of letters of credit (among others), may experience direct impacts from the closure of SVB and uncertainty remains over liquidity concerns in the broader financial services industry. Similar impacts have occurred in the past, such as during the 2008-2010 financial crisis.

Our discovery and development activities are focused on the development of novel covalent small molecule therapies, initially targeted at menin, to treat patients with diabetes and obesity, and the approach we are taking to discover and develop such product candidates is novel, may never lead to marketable products and may not ultimately represent a significant market.

The discovery and development of covalent small molecule therapies for patients with diabetes and obesity, with a particular focus on menin, is an emerging field. While there is scientific evidence to support the feasibility of developing covalent therapies, the significant complexity and potential safety and toxicity concerns associated with poorly designed covalent binders have historically discouraged drug developers from pursuing this drug class. In particular, a significant risk for toxicity is posed by these small-moleculesmall covalentmolecule binders if they demonstrate a more promiscuous binding profile than intended, which can potentially cause unacceptable levels of off-target interactions. While we believe the significant expertise, foundational knowledge and capabilities that our management team members have accumulated over their extensive careers and that we have expanded and refined since our inception positions us to overcome such challenges, there can be no assurance that we will be successful. Even if we are able to limit off-target interaction, there can be no assurance that treatment with any of our novel covalent small molecule product candidates will demonstrate the deep inactivation of their targets or offer greater therapeutic windows than conventional non-covalent drugs. It is possible that the targets we select, such as menin, could be effectively and safely treated by more frequent dosing of non-covalent drugs, which could limit the potential advantages or perceived benefits of our covalent inhibitorand non-covalent product candidates.

Our lead product candidate, icovamenib, isand our next-generation product candidate, BMF-650, are in clinical development, and we dosed the first participant with our second product candidate, BMF-500, in October 2023, following clearance of our IND by the FDA in May 2023.development. Our current data is primarily limited to clinical data in a relatively small patient population for icovamenib, as well as animal models and preclinical cell lines for icovamenib, BMF-500 and BMF-650. These results may not be replicated in larger clinical trials, or, in the case of preclinical data, translate into humans. As such, even if we are able to develop small-moleculenovel small molecule therapy candidates that demonstrate positive results in preclinical studies or early-stage clinical trials, there can be no assurance that such product candidates will subsequently demonstrate significant clinical benefit in vivo or in larger trials or will be well-tolerated.

We are early in our development efforts. We have not yet successfully completed clinical testing of our lead product candidate, icovamenib, in human subjects for various types of type 2 diabetes or type 1 diabetes, or our second product candidate, BMF-500,BMF-650, inas humana subjectsnext-generation fororal relapsedGLP-1 or refractory acute leukemia with FLT3 wild-type and FLT3 mutations, including those with MLLr/NPM1 mutations.RA. Our ability to generate product revenue, which we do not expect will occur for many years, if ever, will depend heavily on the successful clinical development and eventual commercialization of icovamenib, BMF-500, and one or more of our future product candidates.BMF-650. The success of our product candidates will depend on several factors, including the following:

our ability to continue our business operations and product candidate research and development, and adapt to any changes in the regulatory approval process, manufacturing supply or clinical trial requirementsrequirements, disruptions of staffing and operations at the FDA or other government agencies and timing due to aany continued and prolonged public health emergencies, such as the COVID-19 pandemicemergencies;

successful completion of preclinical studiesstudies, regulatory submissions and clinical trials;

successful initiation, patient enrollment in, and completion of current and future clinical trials, including our ongoing Phase I clinical trial of icovamenib in various types of liquid tumors, our Phase I/Ib clinical trial of icovamenib in various types of solid tumors, our Phase I/II clinical trial of icovamenib in type 2 diabetes,diabetes and our Phase II clinical trial of icovamenib in insulin-deficient type 12 diabetes,diabetes andas well as our Phase I clinical trial offor BMF-500 in relapsed or refractory acute leukemia with FLT3 wild-type and FLT3 mutations, including those with MLL1r / NPM1 mutationsBMF-650;

Many of these factors are beyond our control, and it is possible that we may never obtain regulatory approval for our product candidates even if we expend substantial time and resources seeking their development and approval. For example, in June 2024, we announced that the FDA had imposed a clinical hold on the Phase I/II clinical trials of icovamenib in type 2 and type 1 diabetes. We worked to diligently resolve the hold, and in September 2024, the FDA lifted the clinical hold. If we do not achieve regulatory approval in a timely manner or at all, we could experience significant delays or an inability to commercialize our current or future product candidates, which wouldcould materially adversely affect our business. If we do not receive regulatory approvals for our current or future product candidates, we will not be able to continue our operations.

In order to obtain FDA approval to market a newnovel small molecule product, we must demonstrate the safety and efficacy of our product candidates in humans to meet the FDA requirements. To meet these requirements, we will have to conduct adequate and well-controlled clinical trials. Clinical testing is expensive, time-consuming, and subject to uncertainty. Before we can commence clinical trials for a product candidate, we must complete extensive preclinical studies that support our planned and future INDs in the United States. At present, we haveare advancing two product candidates, icovamenib and BMF-500, under investigation in clinical trials.BMF-650. We cannot be certain of the timely completion or outcome of our preclinical studies and clinical trials and cannot predict if the FDA will allow our existing and proposed clinical programs to proceed or continue to proceed, or if the outcomes of our preclinical studies and clinical trials will ultimately support further development of our programs. Our lead product candidate, icovamenib, is in clinical development in type 1 andfor type 2 diabetes, and we cannot be sure that we will be able to submit INDs or similar applications with respect to additional indications or other product candidates on the timelines we expect, if at all, and we cannot be sure that submission of IND or similar applications will result in the FDA or other regulatory authorities allowing clinical trials to begin.

failure to perform in accordance with the FDA’s or any other regulatory authority’s GCPs,Good Clinical Practices (GCPs), or applicable regulatory guidelines in other countries;

In addition, disruptions caused by continued and prolonged public health emergencies such as the COVID-19 pandemic,emergencies, may increase the likelihood that we encounter such difficulties or delays in initiating, enrolling, conducting or completing our planned and ongoing preclinical studies and clinical trials. Any inability to successfully initiate or complete preclinical studies or clinical trials could result in additional costs to us or impair our ability to generate revenue from product sales. In addition, if we make manufacturing or formulation changes to our product candidates, we may be required to or we may elect to conduct additional studies to bridge our modified product candidates to earlier versions. Clinical trial delays could also shorten any periods during which our products, if and when approved, have patent protection and may allow our competitors to bring products to market before we do, which could impair our ability to successfully commercialize our product candidates and may seriously harm our business.

We will be required to demonstrate with substantial evidence through well-controlled clinical trials that our product candidates are safe and effective before we can seek regulatory and marketing approvals for their commercial sale. Success in preclinical studies does not mean that future clinical trials will be successful. For instance, we do not know whether icovamenib, BMF-500, or BMF-650 will perform in clinical trials as icovamenib, BMF-500, or BMF-650they have performed in preclinical studies, nor can we predict how our future product candidates will perform in future preclinical studies or clinical trials. Product candidates in later-stage clinical trials may fail to demonstrate sufficient safety and efficacy to the satisfaction of the FDA and other comparable foreign regulatory authorities despite having progressed through preclinical studies and early-stage clinical trials. Regulatory authorities may also limit the scope of later-stage trials until we have demonstrated satisfactory safety, which could delay regulatory approval, limit the size of the patient population to which we may market our product candidates or prevent regulatory approval. In some instances, there can be significant variability in safety and efficacy results between different clinical trials of the same product candidate due to numerous factors, including changes in trial protocols, differences in size and type of the patient populations, differences in and adherence to the dose and dosing regimen and other trial protocols and the rate of dropout among clinical trial participants. Patients treated with our product candidates may also be undergoing surgical, radiation and chemotherapy treatments and may be using other approved products or investigational newproduct drugs,candidates, which can cause side effects or adverse events that are unrelated to our product candidates. As a result, assessments of efficacy can vary widely for a particular participant, and from patient to patient and site to site within a clinical trial. This subjectivity can increase the uncertainty of, and adversely impact, our clinical trial outcomes.

AnyWe futureface risks related to global health emergencyemergencies such as a pandemic, epidemic, or outbreak of an infectious diseasedisease, similar to the COVID-19 pandemicwhich could materially adversely impact our business, results of operations, and financial condition, including our preclinical studies and clinical trials.

As a result of any futureAny global health emergency such as a pandemic, epidemic, or outbreak of an infectious disease, we have experienced, and may in the future experience disruptions that could severely impact our business, preclinical studies and clinical trials, including:

interruptions or delays to our sourced discovery and clinical activities; and changes in clinical site procedures and requirements as well as regulatory requirements for conducting clinical trials during theany pandemic.global health emergency.

If we experience delays or difficulties in the enrollment and/or retention of eligible participants in clinical trials, our regulatory submissions or receipt of necessary marketing approvals could be delayed or prevented.

availability and efficacy of approved drugs or other methods of treatment for the disease under investigationinvestigation, or availability of competing clinical trials;

delays in or temporary suspension of the enrollment of participants in our planned clinical trials due to aany continued and prolonged public health emergency such as the COVID-19 pandemic;

the ability to monitor participants adequately during and after treatment; and proximity and availability of clinical trial sites for prospective participants.

These factors may make it difficult for us to enroll enough participants to complete our clinical trials in a timely and cost-effective manner. Our inability to enroll a sufficient number of eligible participants for our clinical trials would result in significant delays or may require us to abandon one or more clinical trials altogether. Enrollment delays in our clinical trials may result in increased development costs for our product candidates and jeopardize our ability to obtain marketing approval for the sale of our product candidates. Furthermore, even if we are able to enroll a sufficient number of eligible participants for our clinical trials, we may have difficulty maintaining participation in our clinical trials through the treatment and any follow-up periods.

Type 2 diabetes is a highly heterogeneous disease, and there are over sixty approved therapies being utilized in treating diabetes at various stages of the disease progression, with early lines of therapies largely genericized. There is also a significant industry pipeline of potentially emerging new treatments all addressing patients either in front line or as a follow-on treatment either in monotherapy or in combination.

The pharmaceutical industry is characterized by rapidly advancing technologies, intense competition, and a strong emphasis on proprietary products. Our future success may depend in part on our ability to maintain a competitive position with our FUSION™ system platform. If we fail to stay at the forefront of technological change in utilizing our platform to create and develop product candidates, we may be unable to compete effectively. Our competitors may render our approach obsolete by advances in existing technological approaches or the development of new or different approaches, potentially eliminating the advantages in our drug discovery process that we believe we derive from our research approach and platform. While we believe that icovamenib, BMF-500, BMF-650, our discovery platform, knowledge, and scientific resources provide us with competitive advantages, we face potential competition from many different sources, including commercial biopharmaceutical enterprises, academic institutions, government agencies and private and public research institutions. Many of our competitors, either alone or with their collaborators, have significantly greater financial, technical, manufacturing, marketing, sales and supply resources or experience than we do. If we successfully obtain approval for any product candidate, we will face competition based on many different factors, including the safety and effectiveness of our products, the timing and scope of marketing approvals for these products, the availability and cost of manufacturing, marketing and sales capabilities, price, reimbursement coverage and patent position. Any drug candidates that we successfully develop and commercialize will likely compete with existing therapies and new therapies that may become available in the future.

The incidence and prevalence for target patient populations of icovamenib, BMF-500icovamenib and BMF-650 are based on estimates and third-party sources. If the market opportunities for icovamenib, BMF-500icovamenib and BMF-650 or any future product candidate we may develop, if and when approved, are smaller than we estimate or if any approval that we obtain is based on a narrower definition of the patient population, our revenue and ability to achieve profitability might be materially and adversely affected.

Periodically, we make estimates regarding the incidence and prevalence of target patient populations for particular diseases based on various third-party sources and internally generated analysis and use such estimates in making decisions regarding our drug development strategy, including acquiring or in-licensing product candidatesstrategy and determining indications on which to focus in non-clinical or clinical trials.

The incidence and prevalence for target patient populations of icovamenib, BMF-500icovamenib and BMF-650 are based on estimates and third-party sources. These estimates may be inaccurate or based on imprecise data. For example, the total addressable market opportunity will depend on, among other things, acceptance of our drugs by the medical community and patient access, drug pricing and reimbursement. The number of patients in the addressable markets may turn out to be lower than expected, patients may not be otherwise amenable to treatment with our drugs, or new patients may become increasingly difficult to identify or gain access to. If the market opportunities for icovamenib, BMF-500, BMF-650 or any future product candidate we may develop, if and when approved, are smaller than we estimate or if any approval that we obtain is based on a narrower definition of the patient population, our revenue and ability to achieve profitability might be materially and adversely affected.

The biotechnology and pharmaceutical industries are characterized by the rapid evolution of technologies and understanding of disease etiology, intense competition and a strong emphasis on intellectual property. We believe that our approach, strategy, scientific capabilities, know-how and experience provide us with competitive advantages. In addition, we believe we are currently the only company in the United States clinically developing irreversible covalent small molecule product candidatesbinders specifically targeted against menin. More broadly, weWe define ourselves as targeted drug developers focused on covalent small molecule therapeutics and as such expect substantial competition from multiple sources, including major pharmaceutical, specialty pharmaceutical, and existing or emerging biotechnology companies, academic research institutions and governmental agencies and public and private research institutions worldwide. Many of our competitors, either alone or through collaborations, have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than we do.

Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These companies may be or may become interested in discovery and development of covalent binders that may compete with us against menin or related targets at scale and in an integrated way. Even if they do not advance programs with the same mechanism of action as ours, these companies could develop products or product candidates that are competitive with ours or that have a superior product profile, and may do so at a rapid pace. These competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and participant enrollment in clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs. As a result, our competitors may discover, develop, license or commercialize products before or more successfully than we do. We face competition from segments of the pharmaceutical, biotechnology and other related markets that pursue the development of therapies that target covalent binding against protein targets of interest to us.

We face competition with respect to our current product candidates and will face competition with respect to future product candidates, from segments of the pharmaceutical, biotechnology, and other related markets that pursue targeted therapies for patients with diabetes and obesity. Our competitors will also include companies that are or will be developing other targeted therapies, including small molecule, antibody, or protein degraders for the same indications that we are targeting. For example, the Wegovy® pill was approved in December 2025 and is indicated with a reduced calorie diet and increased physical activity for adults with obesity, or with overweight who also have weight-related medical problems, to help them lose weight and keep it off. If icovamenib, BMF-500, BMF-650 or our future product candidates do not offer sustainable advantages over competing products, we may otherwise not be able to successfully compete against current and future competitors.

Our covalentnovel small molecule product candidates may cause significant adverse events, toxicities or other undesirable side effects when used alone or in combination with other approved products or investigational newproduct drugscandidates that may result in a safety profile that could prevent regulatory approval, prevent market acceptance, limit their commercial potential or result in significant negative consequences.

If our product candidates are associated with undesirable side effects or have unexpected characteristics in preclinical studies or clinical trials when used alone or in combination with other approved products or investigational newproduct drugscandidates, 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. Treatment-related side effects could also affect participant recruitment or the ability of enrolled participants to complete the trial or result in potential product liability claims. Any of these occurrences may prevent us from achieving or maintaining market acceptance of the affected product candidate and may adversely affect our business, financial condition and prospects significantly.

Icovamenib, BMF-500, BMF-650 or future product candidates may be used in populations for which safety concerns may be reviewed by regulatory agencies. For example, if the administration of icovamenib leads to levels of menin inhibition that far exceed those achieved by well-studied non-covalent menin inhibitors, it is possible that participants' responses could be both unexpected and negative. In addition, we or our future collaborators may study icovamenib in combination with other therapies, which may exacerbate adverse events associated with the therapy. Further, our product candidates willmay be used in participants that have weakened immune systems, which may exacerbate any potential side effects associated with their use. Participants treated with icovamenib, BMF-500, BMF-650 or any of our future 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 candidate but may still impact the success of our clinical trials. The inclusion of critically ill participants in our clinical trials may result in deaths or other adverse medical events due to other therapies or medications that such participants may be using or due to the gravity of such participants’ illnesses. For example, it is expected that some of the participants enrolled in our clinical trials of icovamenib will die or experience major clinical events either during the course of our clinical trials or after participating in such trials. Results of our trials could reveal a high and unacceptable severity and prevalence of these or other side effects.

We are a clinical-stage diabetes and obesity medicines company focuseddedicated onto thedeveloping discovery and development of oral covalentnovel small molecule drugstherapies to treat and improve the lives of patients with metabolic diseases. A covalent small molecule drug is a synthetic compound that forms a permanent bond to its target protein and offers a number of potential advantages over conventional non-covalent drugs, including greater target selectivity, lower drug exposure, and the ability to drive a deeper, more durable response. Leveraging our extensive expertise in covalent binding chemistry and development, we built our proprietary FUSION™ System discovery platform to advance a pipeline of novel small molecule product candidates.

Our lead clinical program’s drug candidate, icovamenib, is currently being developed as an orally bioavailable, and selectiveselective, covalent inhibitor of menin currently in two clinical and multiple preclinical studies, investigating icovamenib’s potential in type 1 and type 2 diabetes, as well as its impact in obesity. Menin serves as a checkpoint to prevent beta cell proliferation. Thus, wethe believedata support that inhibiting menin via icovamenib has the potential to enable the proliferation, preservation, and reactivation of healthy, functionfunctional beta cells capable of producing insulin, thereby leading to long-term glycemic control in patients with type 1 and type 2 diabetes. Menin is also an important transcriptional regulator known to play a direct role in oncogenic signaling in multiple cancers and in beta cell homeostasis.

In preclinical studies, the administration of icovamenib has produced a pronounced effect in preclinical models of diabetes, normalizing glucose levels during treatment and even after drug washout. As of December 31, 2024 icovamenib is being evaluated in type 1 and type 2 diabetes across two ongoing clinical trials. With itsour strategic focus to become a diabetes and obesity medicines company, we planare to concludeconcluding our studies exploring icovamenib’s potential in oncology and plan to explore partnerships to further advance our oncology assets (BMF-500, a covalent inhibitor of FLT3, currently in a Phase I studytrial), while concentrating internal resources on metabolic disorders.

Beyond icovamenib, we are utilizing our novel FUSION™ System to pioneer covalent treatments against other high-value genetic drivers of disease. In OctoberSeptember 2024,2025, we announced thethat nomination of BMF-650BMF-650, our investigational, next-generation, oral small molecule GLP-1 RA, whichreceived IND-clearance from the FDA. Initiation of our Phase I GLP-131 trial for BMF-650 in obese, otherwise healthy volunteers is currentlyongoing, advancingand throughdata IND-enablingis studies.anticipated in the second quarter of 2026. With its unique pharmacokinetic profile and enhanced bioavailability, we believe BMF-650 has the potential to provide a best-in-class therapeutic option for diabetes and obesity. Our goal is to utilize our capabilities and our FUSION™ System platform to become the leader in developing covalent small molecules to maximize the depth and durability of clinical benefit when treating various diseases.

As of December 31, 2024,2025, we had an accumulated deficit of $387.3$449.0 million. We incurred net losses of $138.4$61.8 million and $117.3$138.4 million for the years ended December 31, 20242025 and 2023,2024, respectively. Based on our current operating plan, we believe that our existing cash and cash equivalents, and restricted cash as of December 31, 2024,2025, without any future financing, will notonly be sufficient for us to continuefund asour aoperations going concern for at least one year frominto the issuancefirst datequarter of the financial statements appearing elsewhere in this Annual Report on Form 10-K.2027. We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future, and our net losses may fluctuate significantly from period to period, depending on the timing of and expenditures on our planned research and development activities.

We maywill need to raise additional capital in the future to fund our operations, including to conduct and complete clinical trials for any product candidates. If sufficient funds on acceptable terms are not available when needed, we could be required to significantly reduce our operating expenses and delay, reduce the scope of, or eliminate one or more of our development programs.

We currently rely, and expect to continue to rely, on third parties for the manufacture of our product candidates. All of our product candidates are novel small molecules and are manufactured in synthetic processes from available or custom synthesized starting materials. The chemistry is scalable and uses commonly available pharmaceutical equipment in the manufacturing process. We expect to continue to develop product candidates that can be produced cost-effectively at contract manufacturing facilities. In addition, we do not yet have a marketing or sales organization or commercial infrastructure. Accordingly, we will incur significant expenses to develop a marketing and sales organization and commercial infrastructure in advance of generating any product sales.

In April 2021, we completed our initial public offering (IPO) and issued an aggregate of 9,000,000 shares of our common stock at a price of $17.00 per share. Subsequent to the close, an additional 823,532 shares were issued in connection with the partial exercise by the underwriters of their option to purchase additional shares of common stock. In addition, immediately prior to the closing of the IPO, all outstanding shares of our convertible preferred stock automatically converted into 7,064,925 shares of common stock. Proceeds from the IPO, net of underwriting discounts and commissions and offering costs were $152.8 million. On April 3, 2023, we issued and sold 5,750,000 shares of common stock, which included 750,000 shares sold pursuant to the exercise of the underwriters’ over-allotment option, at a public offering price of $30.00 per share in an underwritten public offering pursuant to a shelf registration on Form S-3. Our net proceeds from the offering were $161.8 million, after deducting underwriting discounts and commissions and offering costs of $10.7 million. During the twelve months ended December 31, 2025, we issued 2,271,122 shares of our common stock for aggregate proceeds of $4.9 million, net of commissions and offering costs from our 2022 ATM Program.

We expense research and development costs in the periods in which they are incurred. NonrefundableNon-refundable advance payments for goods or services to be received in future periods for use in research and development activities are deferred and capitalized. The capitalized amounts are then expensed as the related goods are delivered and as services are performed. We track direct costs by stage of program, clinical or preclinical. However, we do not track indirect costs on a program specific or stage of program basis because these costs are deployed across multiple programs and, as such, are not separately classified.

We expect our research and development expenses to increase substantially during the next few years as we seek to initiate and complete clinical trials, pursue regulatory approval of icovamenib and BMF-500,advance BMF-650 and advance our other programs,programs through preclinical and clinical development. Predicting the timing or the final cost to complete our clinical program or validation of our manufacturing and supply processes is difficult and delays may occur because of many factors. The process of conducting the necessary preclinical and clinical research to obtain regulatory approval is costly and time-consuming. To the extent that our product candidates continue to advance into clinical trials, as well as advance into larger and later stage clinical trials, our expenses will increase substantially and may become more variable.

the scope, rate of progress, expense and results of our ongoing clinical trials, including our ongoing Phase I/II clinical trial of icovamenib in type 2 diabetes and Phase II clinical trial of icovamenib in type 1 diabetes, enrollment in our preclinicalPhase developmentI activities,clinical trial for BMF-650, as well as any future preclinical development and clinical trials of our product candidates, and other research and development activities we may conduct;

per patientparticipant trial costs;

the number of patientsparticipants who participate in the trials;

the length of time required to enroll eligible patientsparticipants;

the drop-out or discontinuation rates of patientsparticipants;

the timingtiming, receipt, and terms of any approvals from applicable regulatory authorities including the FDA and non-U.S. regulators;

maintainingour ability to maintain a continued acceptable safety profile of our product candidates following approval, if any, of any of our product candidates;

Interest and other income, net consists primarily of interest income earned on our investmentscash and non-cashcash interest income (loss) related to accretion (amortization) of the discount (premium) on marketable securities.equivalents.

We have funded our operations primarily through the sale and issuance of shares of our common and convertible preferred stockstock, pre-funded and common warrants and the issuance of unsecured promissory notes from inception through December 2020.2020, In April 2021, we completed our IPO and issued an aggregate of 9,000,000 sharesissuance of our common stock atthrough aour price of $17.00 per share. Following the close of the IPO, an additional 823,532 shares were issuedIPO in connectionApril with2021, theour partialpublic exerciseofferings byin theMarch underwriters2023, ofJune their option to purchase additional shares of common stock. Proceeds from the IPO, net of underwriting discounts2025 and commissionsOctober 2025 and offeringthrough costs,sales wereunder $152.8our million.2022 ATM Program.

On October 14, 2022, we filed a shelf registration statement on Form S-3 (the Shelf2022 Registration Statement) with the SEC relating to the registration of up to an aggregate of $350.0 million in shares of our common stock, preferred stock, debt securities, warrants and units or any combination thereof. The Shelf2022 Registration Statement was declared effective by the SEC on October 24, 2022. In April 2023, pursuant to the Shelf2022 Registration Statement, we sold an aggregate of 5,750,000 shares of common stock at a price of $30.00 per share in an underwritten public offering for gross proceeds of $172.5 million, resulting in net proceeds of $161.8 million after deducting underwriting discounts,discounts and commissions, and offering costs. On August 5, 2025, we filed the 2025 Registration Statement with the SEC relating to the registration of up to an aggregate of $300.0 million in shares of our common stock, preferred stock, debt securities, warrants and units or any combination thereof to replace the 2022 Registration Statement. The 2025 Registration Statement was declared effective by the SEC on August 15, 2025.

Additionally, we are party to an equity distribution agreement, dated November 25, 2022, with Piper Sandler & Co. (Piper Sandler) with respect to anthe at-the-market2022 offeringATM program,Program, under which we may offer and sell, from time to time at our sole discretion, shares of our common stock having an aggregate offering price of up to $100.0 million (which iswas included in the $350.0 million originally registered under the Shelf2022 Registration Statement and is now included in the $300.0 million originally registered under the 2025 Registration Statement) through Piper Sandler as the sales agent. In the year endedThrough December 31, 2024,2025, we didhave notreceived sellaggregate anyproceeds sharesfrom our 2022 ATM Program of common$4.9 stockmillion, net of commissions and offering costs, pursuant to the salesissuance agreementof with2,271,122 Pipershares. Sandler.As of December 31, 2025, we have $94.8 million available under the 2022 ATM Program.

As of December 31, 2024,2025, we had cash, cash equivalents and restricted cash of $58.6$56.2 million. As of December 31, 2024,2025, we had an accumulated deficit of $387.3$449.0 million. We have incurred substantial operating losses and have used cash in our operating activities since inception. Without any future financing, the current operating plan under the existing cash and cash equivalents, and restricted cash as of December 31, 2024,2025, will notonly be sufficient for us to fund our operatingoperations expenses and capital expenditure requirements for at least twelve months followinginto the issuancefirst datequarter of the financial statements.2027. Our ability to continue as a going concern will require us to obtain additional financing to fund our operations and there can be no assurance that additional financing will be available to us or that such financing, if available, will be available on terms acceptable to us. Accordingly, there is substantial doubt about our ability to continue as a going concern.

the scope, timing, progress, duration, costs and results of our clinical trials, drug discovery, preclinical development activities,activities and laboratory testing and clinical trials for our product candidates;

Net Cash Provided by (Used in) Investing Activities

We have incurred significant net losses in each reporting period since we commenced operations in August 2017. Our net losses were $12.4$20.7 million and $29.3$50.0 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively. As of MarchJune 31,30, 2026, we had an accumulated deficit of $461.5$469.8 million. Substantially all of our losses have resulted from expenses incurred in connection with our research and development programs and from general and administrative costs associated with our operations. We expect to continue to incur significant losses for the foreseeable future, and we expect these losses to increase substantially if and as we:

As of MarchJune 31,30, 2026 we had $45.1$35.2 million in cash, cash equivalents, and restricted cash. Based on our current operating plan, we believe that our existing cash and cash equivalents, and restricted cash as of MarchJune 31,30, 2026, without any future financing, will not be sufficient for us to continue as a going concern for at least one year from the issuance date of the unaudited condensed financial statements appearing elsewhere in this Quarterly Report on Form 10-Q. Our estimate as to how long we expect our existing capital resources to be able to continue to fund our operations is based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. Changing circumstances, some of which may be beyond our control, could cause us to consume capital significantly faster than we currently anticipate, and we may need to seek additional funds sooner than planned through public or private equity offerings, debt financings, collaborations and licensing arrangements or other sources. Such financing may dilute our stockholders or restrict our operating activities. To the extent we raise additional funds by issuing equity securities, our stockholders may experience dilution. Any future debt financing into which we enter may impose upon us additional covenants that restrict our operations, including limitations on our ability to incur liens or additional debt, pay dividends, repurchase our common stock, make certain investments and engage in certain merger, consolidation, or asset sale transactions. Any debt financing or additional equity that we raise may contain terms that are not favorable to us or our stockholders. If we are unable to raise additional funds when needed, we may be required to delay, reduce, or terminate some or all of our development programs and clinical trials. We may also be required to sell or license other rights to our product candidates in certain territories or indications that we would prefer to develop and commercialize ourselves. 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. If we raise additional funds through upfront payments or milestone payments pursuant to strategic collaborations with third parties, we may have to relinquish valuable rights to our product candidates or grant licenses on terms that are not favorable to us. 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 date, we have not generated any revenues from product sales and have incurred significant operating losses in each year since our inception and we anticipate that losses may continue for the next several years or until such time as we can generate substantial revenues and achieve profitability. In connection with the preparation of this Quarterly Report on Form 10-Q for the period ended MarchJune 31,30, 2026, our management has concluded that there is substantial doubt as to whether we can continue as a going concern for the twelve months following the issuance of this Quarterly Report on Form 10-Q. Our ability to continue as a going concern is dependent upon raising capital to maintain current operations and continue research and development efforts. We plan to raise additional capital to fund our operations through public or private equity offerings, debt financings, and/or potential collaborations and license arrangement or other sources. There is no assurance, however, that any additional financing or any revenue-generating collaboration will be available when needed or that we will be able to obtain financing or enter into a collaboration on terms acceptable to us.

successful initiation, patient enrollment in, and completion of current and future clinical trials, including our ongoing Phase II clinical trial of icovamenib in type 2 diabetes and our Phase II clinical trial of icovamenib in insulin-deficient type 2 diabetes as well as our Phase I clinical trial for BMF-650BMF-650, including the additional cohort in the Phase I clinical trial announced in June 2026;

In order to obtain FDA approval to market a novel small molecule product, we must demonstrate the safety and efficacy of our product candidates in humans to meet the FDA requirements. To meet these requirements, we will have to conduct adequate and well-controlled clinical trials. Clinical testing is expensive, time-consuming, and subject to uncertainty. Before we can commence clinical trials for a product candidate, we must complete extensive preclinical studies that support our planned and future INDs in the United States. At present, we are advancing two product candidates, icovamenib and BMF-650. We cannot be certain of the timely completion or outcome of our preclinical studies and clinical trials and cannot predict if the FDA will allow our existing and proposed clinical programs to proceed or continue to proceed, or if the outcomes of our preclinical studies and clinical trials will ultimately support further development of our programs. Leadership changes at the FDA in the current administration may compound this uncertainty. Our lead product candidate, icovamenib, is in clinical development for type 2 diabetes and we recently concluded a Phase II clinical trial of icovamenib in type 1 diabetes, and we cannot be sure that we will be able to submit INDs or similar applications with respect to additional indications or other product candidates on the timelines we expect, if at all, and we cannot be sure that submission of IND or similar applications will result in the FDA or other regulatory authorities allowing clinical trials to begin.

We face competition with respect to our current product candidates and will face competition with respect to future product candidates, from segments of the pharmaceutical, biotechnology, and other related markets that pursue targeted therapies for patients with diabetes and obesity. Our competitors will also include companies that are or will be developing other targeted therapies, including small molecule, antibody, or protein degraders for the same indications that we are targeting. For example, the Wegovy® pill was approved in December 2025 and is indicated with a reduced calorie diet and increased physical activity for adults with obesity, or with overweight who also have weight-related medical problems, to help them lose weight and keep it off. Additionally, in April 2026, FoundayoTM was approved for use in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or overweight adults with at least one weight-related comorbid condition. Both products carry boxed warnings. If icovamenib, BMF-650 or our future product candidates do not offer sustainable advantages over competing products, we may otherwise not be able to successfully compete against current and future competitors.

We cannot commercialize product candidates in the United States without first obtaining regulatory approval from the FDA. Similarly, we cannot commercialize product candidates outside of the United States without obtaining regulatory approval from comparable foreign regulatory authorities. Before obtaining regulatory approvals for the commercial sale of our product candidates, including our lead product candidate icovamenib,icovamenib and our next-generation product candidate BMF-650, we must demonstrate through lengthy, complex and expensive preclinical studies and clinical trials that our product candidates are both safe and effective for each targeted indication.

The process of obtaining regulatory approvals, both in the United States and abroad, is unpredictable, expensive and typically takes many years following commencement of clinical trials, if approval is obtained at all, and can vary substantially based upon a variety of factors, including the type, complexity and novelty of the product candidates involved. Changes in marketing approval policies during the development period, changes in or the enactment of additional statutes or regulations or changes in regulatory review for each submitted IND, NDA or equivalent application types, may cause delays in the approval or rejection of an application. InThe February 2026, theformer FDA Commissioner publicly indicated that a single adequate and well-controlled pivotal clinical trial supported by confirmatory evidence will be the FDA’s default standard moving forward for novel products, rather than two such trials; this statement was not a formal agency action, and the scope, implementation and durability of this policy position in the current administration remain uncertain. FDA retains broad discretion to require additional clinical data for any product candidate, including a second adequate and well-controlled clinical trial. Additionally, comparable authorities in other countries have substantial discretion in the approval process and may refuse to accept any application or may decide that our data are insufficient for approval and require additional preclinical, clinical or other data. Our product candidates could be delayed in receiving, or fail to receive, regulatory approval for many reasons, including the following:

Changes in funding or disruptions at the FDA, the SEC and other government agencies caused by leadership changes, reduction in staffing, funding shortages or global health concerns could hinder their ability to hire and retain key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.

Federal agencies in the U.S., including the FDA and the SEC, operate pursuant to annual appropriations and other political and budgetary processes, and may from time to time be subject to continuing resolutions, funding lapses, or other fiscal constraints. The FDA is currently funded through September 30, 2026. Without appropriation of sufficient funding to federal agencies, our business operations related to our product development activities for the U.S. market could be impacted. Inadequate funding for the FDA, the SEC, the United States Patent and Trademark Office (USPTO) and other government agencies, including from government shut downs, or other disruptions to these agencies’ operations, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business. For example, the Trump administration has issued executive orders seeking to greatly reduce the size of the federal workforce, including through layoffs and severance packages offered to employees of federal agencies within the executive branch and independent agencies, including the FDA. Any such reduction in personnel may result in longer review times by the FDA and other agencies. In addition, with the change in the U.S.current presidential administration in 2025,administration, there is substantial uncertainty as to the extent and manner in which the U.S. government will seek to modify or revise the requirements and policies of the FDA and other regulatory agencies with jurisdiction over our product candidates and any products for which we obtain approval. This uncertainty could present new challenges and/or opportunities as we navigate development and approval of our product candidates. Additionally, the current administration could issue or promulgate executive orders, regulations, policies or guidance that adversely affect us or create a more challenging or costly environment to pursue the development of new therapeutic candidates. Also, state governments may seek to address or react to changes at the federal level with changes to their regulatory frameworks in a manner that could impact our operations.

As of MarchJune 31,30, 2026, we had 4037 full-time employees, including 2724 employees engaged in research and development activities.

We currently contract certain product development and manufacturing operations to third parties outside the United States, including in China, and we expect to continue to use such third-party manufacturers to support the development of our product candidates. Any disruption in production or inability of our manufacturers outside the United States to produce adequate quantities to meet our needs, whether as a result of a natural disaster or other causes, could impair our ability to operate our business on a day-to-day basis and to continue our development of our product candidates. Furthermore, since these manufacturers are located outside the United States, we are exposed to the possibility of product supply disruption and increased costs in the event of changes in the policies of the United States or other foreign governments, political unrest or unstable economic conditions in these jurisdictions. ForIn example,particular, the United States in July 2026 imposed baseline tariffs generally ranging from 10% - 12.5% on Septembera 25,substantial 2025,portion the currentof U.S. administrationimports. announcedThe aUnited 100%States tariffalso has imposed higher tariffs on brand-name or patented drugs unlesscertain pharmaceutical companies expand their manufacturing operations in the U.S., and may impose more restrictions on goods. While pharmaceutical products are currently excluded from the baseline and “reciprocal” tariffs imposed by the U.S., such tariffs still apply to the raw materials and other products necessary for the manufacture and formulation of our product candidates.products. As such, a trade war or other trade restrictions could lead to additional tariffs on the chemical intermediates we use that are manufactured in China.

Switching or adding third parties to conduct our preclinical studies and clinical trials involves substantial cost and requires extensive management time and focus. In addition, there is a natural transition period when a new third party commences work. As a result, delays may occur, which can materially impact our ability to meet our desired clinical development timelines.

We do not currently own or lease any facility that may be used as our clinical-scale manufacturing and processing facility and must currently rely on outside vendors to manufacture our product candidates. We have not yet caused our product candidates to be manufactured on a commercial scale and may not be able to do so for any of our product candidates, if approved. We will need to negotiate and maintain contractual arrangements with these outside vendors for the supply of our product candidates and we may not be able to do so on favorable terms.

We have and may, in the future, form or seek collaborations or strategic alliances or enter into licensing arrangements, and we may not realize the benefits of such collaborations, alliances or licensing arrangements.

We have and may, in the future, form or seek strategic alliances, create joint ventures or collaborations, or enter into licensing arrangements with third parties that we believe will complement or augment our development and commercialization efforts with respect to our product candidates and any future product candidates that we may develop. Any of these relationships may require us to incur non-recurring and other charges, increase our near and long-term expenditures, issue securities that dilute our existing stockholders or disrupt our management and business.

We will need additional capital in the future to continue our planned operations. To the extent we raise additional capital by issuing equity securities, our stockholders may experience substantial dilution. We may sell common stock, convertible securities or other equity securities in one or more transactions at prices and in a manner we determine from time to time. If we sell common stock, convertible securities or other equity securities in more than one transaction, investors may be materially diluted by subsequent sales. These sales may also result in material dilution to our existing stockholders, and new investors could gain rights superior to our existing stockholders. In November 2022, we entered into our 2022 ATM Program, which provides for the offering, issuance and sale by us of shares of our common stock from time to time for aggregate gross proceeds of up to $100 million in sales deemed to be “at-the-market offerings” as defined by the Securities Act. During the three months ended MarchJune 31,30, 2026, we did not sell any shares pursuant to our 2022 ATM Program.

Our executive officers, directors and their respective affiliates beneficially own approximately 6% of our outstanding voting stock as of MarchJune 31,30, 2026. These stockholders, acting together, may be able to impact matters requiring stockholder approval, particularly if their collective ownership in our company increases. For example, they may be able to impact elections of directors, amendments of our organizational documents or approval of any merger, sale of assets or other major corporate transaction. This may prevent or discourage unsolicited acquisition proposals or offers for our common stock that you may feel are in your best interest as one of our stockholders. The interests of this group of stockholders may not always coincide with your interests or the interests of other stockholders and they may act in a manner that advances their best interests and not necessarily those of other stockholders, including seeking a premium value for their common stock, and might affect the prevailing market price for our common stock.

Significant political, trade, or regulatory developments in the jurisdictions in which we sell our products, if approved, such as those stemming from the change in U.S. federal administration, are difficult to predict and may have a material adverse effect on us. Similarly, changes in U.S. federal policy that affect the geopolitical landscape could give rise to circumstances outside our control that could have negative impacts on our business operations. ForIn example,particular, the United States in July 2026 imposed baseline tariffs generally ranging from 10% - 12.5% on Septembera 25,substantial 2025,portion the currentof U.S. administrationimports. announcedThe aUnited 100%States tariffalso has imposed higher tariffs on brand-name or patented drugs unlesscertain pharmaceutical companiesproducts. expand their manufacturing operations in the U.S. While pharmaceutical products are currently excluded from the baseline and "reciprocal" tariffs imposed by the U.S., such tariffs still apply to the raw materialsThese and other productsU.S. necessarytariff foractions thehave manufactureled governments of other countries to undertake retaliatory trade actions, and formulationmay ofresult ourin productfurther candidates.retaliatory The current U.S. administration has threatened to continue to broadly impose tariffs and increase existing tariffs, which could lead to corresponding punitive actions by the countries with which the U.S. trades.tariffs. Historically, tariffs have led to increased trade and political tensions. In response to tariffs, other countries have implemented or threatened to implement retaliatory tariffs on U.S. goods. Political tensions as a result of trade policies could reduce trade volume, investment, technological exchange and other economic activities between major international economies, resulting in a material adverse effect on global economic conditions and the stability of global financial markets. Any changes in political, trade, regulatory, and economic conditions, including U.S. trade policies, could have a material adverse effect on our financial condition or results of operations.

In preclinical studies, the administration of icovamenib has produced a pronounced effect in preclinical models of diabetes, normalizing glucose levels during treatment and even after drug washout. In October 2025, we reported 52-week results from our Phase II COVALENT-111 trial of icovamenib in type 2 diabetes and most recently in April 2026, we reported topline results from our type 1 diabetes trial (COVALENT-112) of icovamenib in type 1 diabetes. As of MarchJune 31,30, 2026 icovamenib is now being evaluated across two ongoing Phase II clinical trials (COVALENT-211 and COVALENT-212) in type 2 diabetes.

With our strategic focus to become a diabetes and obesity medicines company, we are concludingdiscontinued our studies exploring icovamenib’s potential in oncology and plan to explore partnerships to further advance our oncology assetsasset (BMF-500, a covalent inhibitor of FLT3, currently in a Phase I trialFLT3), while concentrating internal resources on metabolic disorders.

In September 2025, we announced that BMF-650, our investigational, next-generation, oral small molecule glucagon-like peptide-1 GLP-1 receptor agonist (GLP-1 RA), received IND-clearance from the FDA. Our Phase I GLP-131 trial for BMF-650 in obese, otherwise healthy volunteers is ongoing, andwith datatopline isresults anticipatedexpected in the secondthird quarter of 2026. With its unique pharmacokinetic profileprofile, enhanced oral bioavailability, and enhancedpotential bioavailability,for rapid, one-step dose escalation, we believe BMF-650 has the potential to provide a best-in-class therapeutic option for obesity.

As of MarchJune 31,30, 2026, we had an accumulated deficit of $461.5$469.8 million. We incurred net losses of $12.4$20.7 million and $29.3$50.0 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively. Based on our current operating plan, we believe that our existing cash and cash equivalents, and restricted cash as of MarchJune 31,30, 2026, without any future financing, will only be sufficient to fund our operations into the firstsecond quarter of 2027. We expect to continue to incur significant expenses and operating losses for the foreseeable future, and our net losses may fluctuate significantly from period to period, depending on the timing of and expenditures on our planned research and development activities.

In April 2021, we completed our initial public offering (IPO) and issued an aggregate of 9,000,000 shares of our common stock at a price of $17.00 per share. Subsequent to the close, an additional 823,532 shares were issued in connection with the partial exercise by the underwriters of their option to purchase additional shares of common stock. In addition, immediately prior to the closing of the IPO, all outstanding shares of our convertible preferred stock automatically converted into 7,064,925 shares of common stock. Proceeds from the IPO, net of underwriting discounts and commissions and offering costs were $152.8 million. On April 3, 2023, we issued and sold 5,750,000 shares of common stock, which included 750,000 shares sold pursuant to the exercise of the underwriters’ over-allotment option, at a public offering price of $30.00 per share in an underwritten public offering pursuant to a shelf registration on Form S-3. Our net proceeds from the offering were $161.8 million, after deducting underwriting discounts and commissions and offering costs of $10.7 million. During the twelve months ended December 31, 2025, we issued 2,271,122 shares of our common stock for aggregate proceeds of $4.9 million, net of commissions and offering costs from our 2022 ATM Program. We did not issue any shares of common stock or receive any proceeds under our 2022 ATM Program during the threesix months ended MarchJune 31,30, 2026.

We expect our research and development expenses to increase substantially during the next few years as we seek to initiate and complete clinical trials, pursue regulatory approval of icovamenib and advance BMF-650 and our other programs through preclinical and clinical development. Predicting the timing or the final cost to complete our clinical program or validation of our manufacturing and supply processes is difficult and delays may occur because of many factors. The process of conducting the necessary preclinical and clinical research to obtain regulatory approval is costly and time-consuming. To the extent that our product candidates continue to advance into clinical trials, as well as advance into larger and later stage clinical trials, our expenses will increase substantially and may become more variable.

the scope, rate of progress, expense and results of our ongoing clinical trials, including our ongoing Phase II clinical trial of icovamenib in type 2 diabetes, enrollment in our Phase I clinical trial for BMF-650, including an additional cohort announced in June 2026, as well as any future preclinical development and clinical trials of our product candidates, and other research and development activities we may conduct;

Gain on sale of property and equipment was $0.0 million and $0.5 million for the three and six months ended MarchJune 31,30, 20262026, respectively. No gain on sale of property and $0.0equipment was recorded for the three and six months ended MarchJune 31,30, 2025. The gain in the current period was attributable to proceeds from the sale of laboratory equipment.

Comparison of the three and six months ended MarchJune 31,30, 2026 and 2025

Research and development expenses decreased by $13.8$7.4 million during the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025. The decrease of $7.6$3.2 million in external costs was primarily driven by a decrease of $3.8 million related to clinical activities, a decrease of $1.9$1.5 million related to preclinical and exploratory programs, and a decrease of $1.9$1.3 million in other external costs related to consultants, advisors and other professional services to support our clinical studies.studies, and a decrease of $1.0 million of manufacturing costs, offset by an increase of $0.6 million related to clinical activities. Personnel-related expenses decreased by $4.5$2.5 million, including stock-based compensation, due to a decrease in headcount. Facilities and other allocated expenses decreased by $1.7 million due to a decrease in rent and facilities-related costs.

General and administrative expenses decreased by $3.2$1.1 million during the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025. The decrease was primarily driven by a decrease of $1.9$0.9 million related to personnel-related expenses, including stock-based compensation, due to a decrease in headcount and a decrease of $1.1$0.1 million of corporate-related expenses. Facilities and other allocated expenses decreased by $0.2$0.1 million.

Change in fair value of common warrant liability was $0.6$4.1 million for the three months ended MarchJune 31,30, 2026 and $0.0$0.2 million for the three months ended MarchJune 31,30, 2025, attributable to revaluation of the common warrants issued in connection with the June and October 2025 underwritten public offerings (see Note 5). The common warrants are re-measured at each balance sheet date.

Gain on sale of property and equipment was $0.5$0.0 million for the three months ended MarchJune 31,30, 2026 and $0.0June for30, the2025, three months ended March 31, 2025. The gain in the current period was attributable to proceeds from the sale of laboratory equipment.respectively.

Interest and other income, net was $0.4$0.3 million for the three months ended MarchJune 31,30, 2026 compared to $0.5 million for the three months ended March 31, 2025. The decrease of $0.1 million was primarily due to lower interest rates earned on cash and cashJune equivalents30, balance.2025, respectively.

Additionally, we are party to an equity distribution agreement, dated November 25, 2022, with Piper Sandler with respect to the 2022 ATM Program, under which we may offer and sell, from time to time at our sole discretion, shares of our common stock having an aggregate offering price of up to $100.0 million (which was included in the $350.0 million originally registered under the 2022 Registration Statement and is now included in the $300.0 million originally registered under the 2025 Registration Statement) through Piper Sandler as the sales agent. Through MarchJune 31,30, 2026, we have received aggregate proceeds from our 2022 ATM Program of $4.9 million, net of commissions and offering costs, pursuant to the issuance of 2,271,122 shares. As of MarchJune 31,30, 2026, we have $94.8 million available under the 2022 ATM Program.

As of MarchJune 31,30, 2026, we had cash, cash equivalents, and restricted cash of $45.1$35.2 million and an accumulated deficit of $461.5$469.8 million. We have incurred substantial operating losses and have used cash in our operating activities since inception. Without any future financing, the current operating plan under the existing cash and cash equivalents, and restricted cash as of MarchJune 31,30, 2026, will only be sufficient to fund our operations into the firstsecond quarter of 2027. Our ability to continue as a going concern will require us to obtain additional financing to fund our operations and there can be no assurance that additional financing will be available to us or that such financing, if available, will be available on terms acceptable to us. Accordingly, there is substantial doubt about our ability to continue as a going concern.

Net cash used in operating activities was $11.7$21.7 million during the threesix months ended MarchJune 31,30, 2026 and consisted of a net loss of $12.4$20.7 million offset by increasea decrease in net assets of $1.0$0.1 million and non-cash adjustments of $1.7$0.8 million. The increasedecrease in net assets consisted primarily of a decrease in prepaid expenses and other current assets of $1.0 million, a decrease in accrued expenses and other current liabilities of $3.0$0.1 million and a decrease in operating lease liabilities of $0.4$0.7 million, offset by an increase in other assets of $0.4 million and an increase in accounts payable of $1.4less than $0.1 million. Non-cash adjustments consisted primarily of stock-based compensation expense of $1.6$3.2 million, gain on sale of property and equipment of $0.5 million and a non-cash lossgain on the change in fair value of warrant liability of $0.6$3.5 million.

Net cash used in operating activities was $25.7$44.9 million during the threesix months ended MarchJune 31,30, 2025 and consisted of a net loss of $29.3$50.0 million offset by a decrease in net assets of $0.8$2.9 million and non-cash adjustments of $4.4$8.0 million. The decrease in net assets consisted primarily of a decrease in prepaid expenses and other current assets of $1.6 million, a decrease in other assets of $0.6 million, a decrease in accounts payable of $4.7 million and a decrease in operating lease liabilities of $1.7 million, offset by an increase in accrued expenses and other current liabilities of $4.0 million, offset by a decrease in accounts payable of $5.2 million, decrease in prepaid expenses of $1.2 million and a decrease in operating lease liabilities of $0.8$1.3 million. Non-cash adjustments consisted primarily of stock-based compensation expense of $3.2$5.7 million, operating lease expense of $0.8$1.6 million andmillion, depreciation expense of $0.5$0.9 million and a non-cash loss on the change in fair value of warrant liability of $0.2 million.

Net cash provided by investing activities was $0.6 million during the threesix months ended MarchJune 31,30, 2026.

Net cash usedprovided inby investing activities was $0.0 million during the threesix months ended MarchJune 31,30, 2025.

Net cash provided by financing activities was $0.0$0.2 million during the threesix months ended MarchJune 31,30, 2026.

Net cash provided by financing activities was $3.3$42.8 million during the threesix months ended MarchJune 31,30, 20252025, and primarily relates to net proceeds from of issuances of common stock and pre-funded warrants under the public offering and our 2022 ATM Program.

As of MarchJune 31,30, 2026, there have been no material changes from the contractual obligations and commitments as of December 31, 2025 previously disclosed in our Annual Report on Form 10-K filed with the SEC on March 24, 2026.

Our critical accounting policies are described in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Estimates” in our Annual Report on Form 10-K filed with the SEC on March 24, 2026 and the notes to the financial statements appearing elsewhere in this Quarterly Report on Form 10-Q. During the threesix months ended MarchJune 31,30, 2026, except as described in Note 2 to the unaudited condensed financial statements appearing elsewhere in this Quarterly Report on Form 10-Q, there were no material changes to our critical accounting policies from those discussed in our Annual Report on Form 10-K filed with the SEC on March 24, 2026.