IMRX 10-K & 10-Q changes, risk factors and insider trading
Immuneering Corp · Nasdaq · Pharmaceutical Preparations · CIK 1790340 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “A fast track designation from the FDA (or similar designation from a comparable foreign regulatory authority), even when granted for any of our product candidates, may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that our product candidates will receive regulatory approval.”
Removed heading “We have identified conditions and events that raise substantial doubt about our ability to continue as a going concern.”
Largest changes
“For example, the loss of clinical trial data from past, present or future clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the lost data. We also rely on third parties to manufacture our product candidates, and similar events relating to their computer systems could also have a material adverse effect on our business. …”see in full comparison
We and our service providers are from time to time subject to cyberattacks and security incidents. While we do not believe that we have experienced any significant system failure, accident or security breach to date, if such an event were to occur and cause interruptions in our operations or result in the unauthorized acquisition of or access to our trade secrets, health-related or other personal information or other proprietary or sensitive information, it could result in a material disruption of our drug discovery and development programs and our business operations, whether due to a loss of our trade secrets or other similar disruptions, and it may be necessary to notify individuals, governmental authorities, supervisory bodies, the media and other parties pursuant to data privacy and security laws. Notifications and follow-up actions related to a security breach could impact our reputation and cause us to incur significant costs, including legal expenses and remediation costs.see in full comparisonFor example, the loss of clinical trial data from past, present or future clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the lost data. We also rely on third parties to manufacture our product candidates, and similar events relating to their computer systems could also have a material adverse effect on our business. To the extent that any disruption or security breach were to result in a loss of, or damage to, our data, or inappropriate disclosure of confidential or proprietary information, we could be exposed to litigation and governmental investigations, the further development and potential commercialization of our product candidates could be delayed or halted, and we could be subject to significant fines or penalties for any noncompliance with certain state, federal, local and/or international privacy and security laws.
“In addition, we (and likely many of our third-party vendors, agents and other collaborators) are adopting and exploring the use of Artificial Intelligence ("AI") in our business. As an emerging and rapidly evolving technology, our (and, to the extent applicable, our third-party vendors', agents' and other collaborators') use of AI presents risks that could adversely affect our operations, information security and reputation. For example, AI systems may produce inaccurate or flawed outputs due to improper algorithms, or insufficient and/or erroneous training data. …”see in full comparison
“We have identified conditions and events that raise substantial doubt about our ability to continue as a going concern.”see in full comparison
“Additionally, substantial doubt about our ability to continue as a going concern may materially and adversely affect the price per share of our common stock, and it may be more difficult for us to obtain financing. If potential collaborators decline to do business with us or potential investors decline to participate in any future financings due to such concerns, our ability to increase our cash position may be limited. …”see in full comparison
“We will be forced to delay or reduce the scope of our development programs, reduce our research and development and our administrative costs, and/or limit or cease our operations if we are unable to obtain additional funding to support our current operating plan. We have identified conditions and events that raise substantial doubt about our ability to continue as a going concern. As of December 31, 2024, we had $36.1 million in cash and cash equivalents. …”see in full comparison
Full comparison: every changed paragraph (136)
We are a clinical-stagelate-stage clinical oncology company with a limited operating history in developing pharmaceutical products, have not completed any registrational clinical trials and have no products approved for commercial sale, which may make it difficult for you to evaluate our current business and predict our future success and viability.
Pharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk. We are a clinical-stagelate-stage clinical oncology company with a limited operating history in developing pharmaceutical products which makes it difficult to evaluate our business and prospects in future product development. We have no products approved for commercial sale and have not generated any revenue from product sales. To date, we have devoted substantially all of our resources and efforts to providing computational biology services to pharmaceutical and biotechnology companies, organizing and staffing our company, business planning, executing partnerships, raising capital, discovering, identifying and developing potential product candidates, securing related intellectual property rights and undertaking research and preclinical studies and clinical trials of our product candidates, including our ongoing Phase 1/2a clinical trialstrial of atebimetinib (also referred to as IMM-1-104 and IMM-6-415) for the treatment of advanced solid tumors in patients harboring RAS and/or RAF mutant tumors, respectively.tumors. We have not yet demonstrated our ability to successfully complete any registrational clinical trials, obtain marketing approvals, manufacture a commercial-scale product or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization. As a result, it may be more difficult for you to accurately predict our future success or viability to develop new pharmaceutical products than it could be if we had a longer operating history.
We have incurred net losses in each reporting period for the past several years, have not generated any revenue from product sales to date and have financed our operations principally through our historical computational biology services to pharmaceutical and biotechnology companies (which have since ceased), the issuance of convertible debt and the sale of our convertible preferred stock, Class A common stock and Classwarrants Aexercisable for common stock. We have incurred net losses of approximately $61.0$56.0 million and $53.5$61.0 million for the years ended December 31, 20242025 and 2023,2024, respectively. As of December 31, 2024,2025, we had an accumulated deficit of approximately $224.3$280.3 million. As noted below and further described elsewhere in this Annual Report on Form 10-K, we have identified conditions and events that raise substantial doubt about our ability to continue as a going concern for a period of at least one year from the date of issuance of the financial statements appearing within this Annual Report on Form 10-K. Our losses have resulted principally from expenses incurred in research and development of our product candidates, from management and administrative costs and from other expenses that we have incurred while building our business infrastructure. We are currently conducting an ongoing Phase 1/2a clinical trialstrial for each of our product candidates,candidate IMM-1-104 and IMM-6-415,atebimetinib for the treatment of advanced solid tumors and plan to dose the first patient in patientsour harboringMAPKeeper RAS301 and/orregistrational RAFtrial mutantin tumors, respectively.mid-2026. Our other product candidates are in earlier stages of drug development. As a result, we expect that it will be several years, if ever, before we have a commercialized product and generate revenue from product sales. 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 as we discover, develop and market additional potential product candidates.
•advance the development of our current and future product candidates, including IMM-1-104 and IMM-6-415,atebimetinib, through preclinical and clinical development, and, if approved by the FDA or other comparable foreign regulatory authorities, commercialization;
We have identified conditions and events that raise substantial doubt about our ability to continue as a going concern.
We will be forced to delay or reduce the scope of our development programs, reduce our research and development and our administrative costs, and/or limit or cease our operations if we are unable to obtain additional funding to support our current operating plan. We have identified conditions and events that raise substantial doubt about our ability to continue as a going concern. As of December 31, 2024, we had $36.1 million in cash and cash equivalents. Based on our available cash resources, we believe we do not have sufficient cash and cash equivalents on hand to support current operations for at least one year from the date of issuance of the financial statements appearing within this Annual Report on Form 10-K. This condition raises substantial doubt about our ability to continue as a going concern for at least one year from the date that our financial statements for the year ended December 31, 2024 were issued. Nevertheless, our financial statements do not include any adjustments that might result from the outcome of this uncertainty. We will need to raise additional capital to fund our future operations and remain as a going concern. There can be no assurance that we will be able to obtain additional funding on acceptable terms, if at all. To the extent that we raise additional capital through future equity offerings, the ownership interest of common stockholders will be diluted, which may be significant. We cannot guarantee that we will be able to obtain any or sufficient additional funding or that such funding, if available, will be obtainable on terms satisfactory to us. In the event that we are unable to obtain any or sufficient additional funding, there can be no assurance that we will be able to continue as a going concern, and we will be forced to delay, reduce or discontinue some or all of our product development programs and/or other operations.
Additionally, substantial doubt about our ability to continue as a going concern may materially and adversely affect the price per share of our common stock, and it may be more difficult for us to obtain financing. If potential collaborators decline to do business with us or potential investors decline to participate in any future financings due to such concerns, our ability to increase our cash position may be limited. The perception that we may not be able to continue as a going concern may cause others to choose not to deal with us due to concerns about our ability to meet our contractual obligations. If we are unable to continue as a going concern, you could lose part or all of your investment in our Company.
Developing pharmaceutical products, including conducting preclinical studies and clinical trials, is a very time-consuming, expensive and uncertain process that takes years to complete. Our operations have consumed substantial amounts of cash since inception, and we expect our expenses to increase in connection with our ongoing activities, particularly as we initiate and conduct preclinical studies and clinical trials, including any registrational trials, and seek marketing approval for our current and any future product candidates. Even if one or more of the product candidates that we develop is approved for commercial sale, we anticipate incurring significant costs associated with commercializing any approved product candidate. Our expenses could increase beyond expectations if we are required by the FDA or other comparable foreign regulatory authorities to perform clinical trials or preclinical studies in addition to those that we currently anticipate. Other unanticipated costs may also arise. In addition, if we obtain marketing approval for any of our product candidates, we expect to incur significant commercialization expenses related to drug sales, marketing, manufacturing and distribution. Because the design and outcome of our current and anticipated clinical trials are highly uncertain, we cannot reasonably estimate the actual amounts necessary to successfully complete the development and commercialization of any product candidate we develop. We also expect to continue to incur the costs associated with operating as a public company. Accordingly, we will need to obtain substantial additional funding in order to maintain our continuing operations in the future.
As of December 31, 2024,2025, we had $36.1$217.0 million in cash, cash equivalents, and cashmarketable equivalents.securities. Based on our current business plans, we believe that our existing cash, cash equivalents, and cashmarketable equivalentssecurities will be sufficient to fund our development activities and other operations into 2026. As noted above and further described elsewhere in this Annual Report on Form 10-K, we have identified conditions and events that raise substantial doubt about our ability to continue as a going concern for a period of at least one year from the date of issuance of the financial statements appearing within this Annual Report on Form 10-K.2029. Our estimate as to how long we expect our existing cash, cash equivalents, and cashmarketable equivalentssecurities to be able to continue to fund our operating expenses and capital expenditures requirements 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.
•the initiation, progress, timeline, cost and results of our clinical trials for our product candidatescandidates, including our planned registrational trial of atebimetinib in combination with mGnP in first-line pancreatic cancer;
•the outcome, timing and cost of meeting regulatory requirements established by the FDAFDA, EMA, and other comparable foreign regulatory authorities;
Advancing the development of our product candidates will require a significant amount of capital. Our existing cash, cash equivalents, and cashmarketable equivalentssecurities will not be sufficient to fund all of the activities that are necessary to complete the development and potential commercialization of our product candidates.
We will be required to obtain further funding through public or private equity offerings, debt financings, collaborations and licensing arrangements or other sources, which may dilute our stockholders or restrict our operating activities. We do not have any committed external source of funds. Adequate additional financing may not be available to us on acceptable terms, or at all. For example in the past, due to macroeconomic conditions including inflation and higher interest rates, the stock price of biotech companies, including ours, generally declined, making fundraising in our industry more difficult and on less favorable terms. Furthermore, additional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and potentially commercialize our product candidates. Our failure to raise capital as and when needed or on acceptable terms would have a negative impact on our financial condition and our ability to pursue our business strategy, and we may have to delay, reduce the scope of, suspend or eliminate one or more of our research-stage programs, clinical trials or future commercialization efforts. If we are not able to secure adequate additional funding, we plan to make significant reductions in spending. In that event, we may have to delay, scale back, or eliminate some or all of our operations, sell assets and/or seek other strategic alternatives.
We maintain the majority of our cash, cash equivalents, and cashmarketable equivalentssecurities in accounts with major U.S. and multi-national financial institutions, and our deposits at certain of these institutions exceed insured limits. Market conditions have in the past impacted and may in the future impact the viability of these institutions. In the event of failure of any of the financial institutions where we maintain our cash andcash, cash equivalents, and marketable securities, there can be no assurance that we would be able to access uninsured funds in a timely manner or at all. Any inability to access or delay in accessing these funds could adversely affect our business and financial position.
We may seek additional capital through a variety of means, including through public or private equity offerings made pursuant to the Sales Agreement (as defined herein) or otherwise,offerings, debt financings or other sources, including up-front payments and milestone payments from strategic collaborations. To the extent that we raise additional capital through the sale of equity or convertible debt or equity securities, for example,example as we did in AprilAugust 2023,and September 2025, your ownership interest may be diluted, and the terms may include liquidation or other preferences that adversely affect your rights as a stockholder. In addition to dilution, such financings may result in the imposition of debt covenants, increased fixed payment obligations orobligations, other restrictions (including operating restrictions) or other obligations (for example, providing registration or other information rights to certain investors, as we did in connection with private placements of equity securities in 2025) that may affect our business. If we raise additional funds through up-front 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.
We are not permitted to commercialize, market, promote or sell any product candidate in the United States without obtaining marketing approval from the FDA. Foreign regulatory authoritiesauthorities, such as the EMA, impose similar requirements. The time required to obtain approval by the FDA and other comparable foreign regulatory authorities is unpredictable, typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the type, complexity and novelty of the product candidates involved. In addition, approval policies, regulations or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions, which may cause delays in the approval or the decision not to approve an application. Regulatory authorities 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. Even if we eventually complete clinical testing and receive approval of any regulatory filing for our product candidates, the FDAFDA, EMA and other comparable foreign regulatory authorities may approve our product candidates for a more limited indication or a narrower patient population than we originally requested. We have not submitted for, or obtained, regulatory approval for any product candidate, and it is possible that none of our existing product candidates or any product candidates we may seek to develop in the future will ever obtain regulatory approval.
•the FDAFDA, EMA or other comparable foreign regulatory authorities may disagree with the design, implementation or results of our clinical trials, including without limitation with respect to the appropriate or proper escalation of dosing in patients or the use of our product candidates as potential combination therapies;
•the FDAFDA, EMA or other comparable foreign regulatory authorities may determine that our product candidates are not safe and/or not effective, only moderately effective or have undesirable or unintended side effects, toxicities or other characteristics that preclude our obtaining marketing approval or prevent or limit commercial use;
•the population studied in thea clinical trial may not be sufficiently broad or representative to assure efficacy and safety in the full population for which we seek approval;
•the FDAFDA, EMA or other comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials;
•the data collected from clinical trials of our product candidates may not be sufficient to support the submission of a NDA or other submission or to obtain regulatory approval in the United StatesStates, European Union or elsewhere;
•we may be unable to demonstrate to the FDAFDA, EMA or other comparable foreign regulatory authorities that a product candidate’s risk-benefit ratio for its proposed indication is acceptable;
•the FDAFDA, EMA or other comparable foreign regulatory authorities may fail to approve the manufacturing processes, test procedures and specifications or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; and
•the approval policies or regulations of the FDAFDA, EMA or other comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.
This lengthy approval process, as well as the unpredictability of the results of clinical trials, may result in our failing to obtain regulatory approval to market any of our product candidates, which would significantly harm our business, results of operations and prospects. In addition, the FDAFDA, EMA or comparable foreign regulatory authorities may change their policies, adopt additional regulations or revise existing regulations or take other actions, which may prevent or delay approval of our future product candidates under development on a timely basis. Such policy or regulatory changes could impose additional requirements upon us that could delay our ability to obtain approvals, increase the costs of compliance or restrict our ability to maintain any marketing authorizations we may have obtained.
We are a clinical-stage oncology company, and we may not be able to submit additional INDs or IND amendments or comparable documents in foreign jurisdictions to commence additional clinical trials on the timelines we expect, and even if we are able to, the FDA may not permit us to proceed.
We may not be able to submit additional INDs, IND amendments or comparable documents for IMM-1-104 or IMM-6-415,atebimetinib, for which INDsan wereIND was previously submitted, or for our other current or potential product candidates on the timelines we expect. We may also experience manufacturing delays or other delays with IND-enabling studies. Moreover, we cannot be sure that submission of an IND or comparable document will result in the FDA or other comparable foreign regulatory authorities allowing further clinical trials to begin, or that, once begun, issues will not arise that suspend or terminate clinical trials. Additionally, even if such regulatory authorities agree with the design and implementation of the clinical trials set forth in an IND, we cannot guarantee that such regulatory authorities will not change their requirements in the future. These considerations also apply to new clinical trials we may submit as amendments to existing INDs or to a new IND. Any failure to file INDs on the timelines we expect or to obtain regulatory approvals for our trials may prevent us from completing our clinical trials or commercializing our products on a timely basis, if at all.
We are a clinical-stage oncology company, and our company hashave limited experience in designing clinical trials and may experience delays or unexpected difficulties in obtaining regulatory approval for our current and future product candidates.
We are a clinical-stage oncology company, and we have limited experience in designing clinical trials and may be unable to design and execute a clinical trial to support marketing approval.approval, including, for example, our planned registrational trial of atebimetinib in combination with mGnP in first-line pancreatic cancer. We cannot be certain that our ongoing or planned clinical trials or any future clinical trials will be successful. ItFor example, in April 2025 we paused further internal advancement of envometinib (IMM-6-415) and the related Phase 1/2a clinical trial. Further, it is possible that the FDA may refuse to accept, or be delayed in accepting, any or all of our planned NDAs for substantive review or may conclude after review of our data that our application is insufficient to obtain regulatory approval for any product candidates. If the FDA does not approve any of our planned NDAs, it may require that we conduct additional costly clinical trials, preclinical studies or manufacturing validation studies before it will reconsider our applications. Depending on the extent of these or any other FDA-required studies, approval of any NDA or other application that we submit may be significantly delayed, possibly for several years, or may require us to expend more resources than we have available. Any failure or delay in obtaining regulatory approvals would prevent us from commercializing our product candidates, generating revenues and achieving and sustaining profitability. It is also possible that additional studies, if performed and completed, may not be considered sufficient by the FDA to approve any NDA or other application that we submit. If any of these outcomes occur, we may be forced to abandon the development of our product candidates, which would materially adversely affect our business and could potentially cause us to cease operations. We face similar risks for our applications in foreign jurisdictions.jurisdictions with comparable regulatory agencies, including without limitation the EMA.
Before obtaining marketing approval from the FDAFDA, EMA or other comparable foreign regulatory authorities for the sale of our product candidates, we must complete preclinical development and extensive clinical trials to demonstrate the safety and efficacy of our product candidates. Clinical testing is expensive, difficult to design and implement, can take many years to complete and its ultimate outcome is uncertain. A failure of one or more clinical trials can occur at any stage of the process. The outcome of preclinical studies and early-stage clinical trials may not be predictive of the success of later clinical trials. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval of their drugs.
•the FDAFDA, EMA or comparable foreign regulatory authorities disagreeing as to the design, implementation or results of our clinical trials, including without limitation with respect to the appropriate or proper escalation of dosing in patients or the use of our product candidates as potential combination therapies;
•a facility manufacturing our product candidates or any of their components being ordered by the FDAFDA, EMA or comparable foreign regulatory authorities to temporarily or permanently shut down due to violations of cGMP regulations or other applicable requirements, or infections or cross-contaminations of product candidates in the manufacturing process;
•third-party contractors becoming debarred or suspended or otherwise penalized by the FDAFDA, EMA 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 marketing applications.
We could also encounter delays if a clinical trial is suspended or terminated by us, by the IRBs of the institutions in which such trials are being conducted, by a Data Safety Monitoring Board for such trial or by the FDAFDA, EMA or comparable foreign regulatory authorities. Such authorities may impose such a suspension or termination due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDAFDA, EMA or comparable foreign regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a drug, 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 IRBs for reexamination, which may impact the costs, timing or successful completion of a clinical trial.
Further, conducting clinical trials in foreign countries, as we may do for our product candidates,countries presents additional risks that may delay completion of our clinical trials. These risks include the failure of enrolled patients in foreign countries to adhere to clinical protocol as a result of differences in healthcare services or cultural customs, managing additional administrative burdens associated with foreign regulatory schemes, including with respect to healthcare, cybersecurity and data privacy matters, as well as political and economic risks or military conflicts relevant to such foreign countries.
Our development costs will also increase if we experience delays in testing or obtaining marketing approvals. We do not know whether any of our preclinical studies or clinical trials will begin as planned, need to be restructured or be completed on schedule, if at all. Any delay in, or termination of, our clinical trials will delay the submission of an NDA to the FDA or similar applications with comparable foreign regulatory authorities and, ultimately, our ability to commercialize our product candidates, if approved, and generate product revenue. Even if our clinical trials are completed as planned, we cannot be certain that their results will support our claims for differentiation or the effectiveness or safety of our product candidates. TheRegulatory agencies such as the FDA hasand EMA have substantial discretion in the review and approval process and may disagree that our data support the claims we propose.
Moreover, principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and receive compensation in connection with such services. Under certain circumstances, we may be required to report some of these relationships to the FDAFDA, EMA or comparable foreign regulatory authorities. The FDAFDA, EMA or comparable foreign regulatory authorities may conclude that a financial relationship between us and a principal investigator has created a conflict of interest or otherwise affected interpretation of the study. The FDAFDA, EMA or comparable foreign regulatory authorities may therefore question the integrity of the data generated at the applicable clinical trial site and the utility of the clinical trial itself may be jeopardized. This could result in a delay in approval, or rejection, of our marketing applications by the FDAFDA, EMA or comparable foreign regulatory authorities, as the case may be, and may ultimately lead to the denial of marketing approval of one or more of our product candidates.
The outcome of preclinical studies and earlyearlier clinical trials may not be predictive of the success of later clinical trials, and the results of our clinical trials may not satisfy the requirements of the FDA or other comparable foreign regulatory authorities.
Before obtaining regulatory approvals for the commercial sale of any of our product candidates, we will be required to demonstrate with substantial evidence through well-controlled clinical trials that our product candidates are safe and effective for their intended uses. Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical trial process. Success in preclinical studies and early-stage clinical trials does not mean that future clinical trialstrials, such as our planned registrational trial of atebimetinib in combination with mGnP in first-line pancreatic cancer, will be successful. We do not know whether any of our product candidates will perform in current or future clinical trials as they have performed in preclinical studies.studies or prior clinical trials. Product candidates in later-stage clinical trials may fail to demonstrate sufficient safety and efficacy to the satisfaction of the FDAFDA, EMA or other comparable foreign regulatory authorities despite having progressed through preclinical studies and early-stage clinical trials.
Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses and many companies that believed their product candidates performed satisfactorily in preclinical studies and clinical trials nonetheless failed to obtain FDAFDA, EMA or comparable foreign regulatory authority approval. We cannot guarantee that the FDAFDA, EMA or comparable foreign regulatory authorities will interpret trial results as we do, and more trials could be required before we are able to submit applications seeking approval of our product candidates. To the extent that the results of the trials are not satisfactory to the FDAFDA, EMA or comparable foreign regulatory authorities for support of a marketing application, we may be required to expend significant resources, which may not be available to us, to conduct additional trials in support of potential approval of our product candidates. Even if regulatory approval is secured for any of our product candidates, the terms of such approval may limit the scope and use of our product candidate, which may also limit its commercial potential. Furthermore, the approval policies or regulations of the FDAFDA, EMA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval, which may lead to the FDAFDA, EMA or comparable foreign regulatory authorities delaying, limiting or denying approval of our product candidates.
From time to time, we may also disclose interim data from our preclinical studies and clinical trials. For example, we disclosed updated interim safety and efficacy data from the Phase 2a portion of our ongoing Phase 1/2a clinical trial of IMM-1-104atebimetinib in January 2025, and initial interim safety, PK, and PD data from the Phase 1 portion of our ongoing Phase 1/2a clinical trial of IMM-6-415 in January 2025.2026. Interim data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available or as patients from our clinical trials continue other treatments for their disease. Adverse differences between top-line, preliminary and/or interim data and final data could significantly harm our business prospects. Further, disclosure of interim data by us or by our competitors could result in volatility in the trading price of our Class A common stock.
As is the case with pharmaceuticals generally, it is likely that there may be side effects and adverse events associated with the use of our product candidates. Results of our preclinical studies and clinical trials could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics. Undesirable side effects caused by our product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDAFDA, EMA or comparable foreign regulatory authorities. The drug-related side effects could affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. Any of these occurrences may harm our business, financial condition and prospects significantly.
If significant drug-related adverse events or other side effects are observed in any of our current or future clinical trials, we may have difficulty recruiting patients to the clinical trials, patients may drop out of our trials, or we may be required to abandon the trials or our development efforts of that product candidate altogether. We, the FDA, EMA, other comparable regulatory authorities or an IRB may suspend clinical trials of a product candidate at any time for various reasons, including a belief that subjects in such trials are being exposed to unacceptable health risks or adverse side effects. Some potential therapeutics developed in the biotechnology industry that initially showed therapeutic promise in early-stage trials have later been found to cause side effects that prevented their further development. Even if the side effects do not preclude the product candidate from obtaining or maintaining marketing approval, undesirable side effects may inhibit market acceptance due to its tolerability versus other therapies. Any of these developments could materially harm our business, financial condition and prospects.
Patient enrollment is a significant factor in the timing of clinical trials, and the timing of our clinical trials depends, in part, on the speed at which we can recruit patients to participate in our trials, as well as 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 locate and enroll a sufficient number of eligible patients to participate in these trials to such trial’s conclusion as required by the FDAFDA, EMA or other comparable foreign regulatory authorities. Additionally, our clinical trials will compete with other clinical trials for product candidates that focus on the same therapeutic targets as our current and potential future product candidates, which may further limit enrollment of eligible patients or may result in slower enrollment than we anticipate. The eligibility criteria of our clinical trials, once established, may further limit the pool of available trial participants.
We have not conducted, managed or completed large-scale or pivotal clinical trials nor managedcompleted the regulatory approval process with the FDAFDA, EMA or any other regulatory authority. The time required to obtain approvals from the FDAFDA, EMA and other regulatory authorities is unpredictable, and requires successful completion of extensive clinical trials which typically takes many years, depending upon the type, complexity and novelty of the product candidate. The standards that the FDA and its foreign counterparts use when evaluating clinical trial data can and often changes during drug development, which makes it difficult to predict with any certainty how they will be applied. We may also encounter unexpected delays or increased costs due to new government regulations, including future legislation or administrative action, or changes in FDAFDA, EMA or other applicable regulatory authority policy during the period of drug development, clinical trials and FDA regulatory review.
We are also subject to numerous foreign regulatory requirements governing, among other things, the conduct of clinical trials, manufacturing and marketing authorization, pricing and third-party reimbursement. The foreign regulatory approval process varies among countries, and generally includes all of the risks associated with FDA and EMA approval processes described aboveabove, as well as risks attributable to the satisfaction of local regulations in foreign jurisdictions. Moreover, the time required to obtain approval may differ from that required to obtain FDA or EMA approval.
A key element of our strategy is to use and expand our DCT platform to build a pipeline of product candidates and progress these product candidates through clinical development for the treatment of various cancers. Although our research and development efforts to date have resulted in our discovery, preclinical and clinical development of IMM-1-104atebimetinib and other product candidates, it and other product candidates may not be safe or effective for the indications for which we study them in clinical trials, and we may not be able to develop any other product candidates. Our DCT platform is evolving and may not reach a state at which building a pipeline of product candidates is possible.
The scientific research that forms the basis of our efforts to develop product candidates with our platforms is still ongoing. Further, the scientific evidence to support the feasibility of developing therapeutic treatments based on our DCT platform is both preliminary and limited. As a result, we are exposed to a number of unforeseen risks and it is difficult to predict the types of challenges and risks that we may encounter during development of our product candidates. For example, we have only begun testing IMM-1-104 and IMM-6-415 in humans, and have only generated interim data from the ongoing Phase 1/2a trialstrial of IMM-1-104 and IMM-6-415,atebimetinib, and otherwise our data for thesethis product candidatescandidate is limited to animal models and preclinical cell lines, the results of which may not translate into humans. As a result, it is possible that safety or other adverse events or concerns could negatively affect the development of IMM-1-104, IMM-6-415atebimetinib or our other current or future product candidates, including adversely affecting patient enrollment among the patient populations that we intend to treat.
Given the novelty of our technologies, we intend to work closely with the FDAFDA, EMA and comparable foreign regulatory authorities to perform the requisite scientific analyses and evaluation of our methods to obtain regulatory approval for our product candidates; however, due to a lack of comparable experiences, the regulatory pathway with the FDAFDA, EMA and comparable regulatory authorities may be more complex and time-consuming relative to other more well-known therapeutics. Even if we obtain human data to support our product candidates, the FDAFDA, EMA or comparable foreign regulatory agencies may lack experience in evaluating the safety and efficacy of our product candidates developed using our platforms, which could result in a longer than expected regulatory review process, increase our expected development costs, and delay or prevent commercialization of our product candidates. The validation process takes time and resources, may require independent third-party analyses, and may not be accepted or approved by the FDAFDA, EMA and other comparable foreign regulatory authorities. We cannot be certain that our approach will lead to the development of approvable or marketable products, alone or in combination with other therapies.
Additionally, a key element of our strategy is to use and expand our platforms to build a pipeline of product candidates and progress those product candidates through clinical development for the treatment of a variety of different types of diseases. Although our research and development efforts to date have been focused on identifying a pipeline of product candidates directed at various disease types, we may not be able to develop product candidates that are safe and effective. Even if we are successful in building our pipeline, the potential product candidates that we identify may not be suitable for clinical development, including as a result of being shown to have harmful side effects or other characteristics that indicate that they are unlikely to be approvable or marketable products that will receive marketing approval and achieve market acceptance. If we do not continue to successfully develop, get approval for and begin to commercialize any product candidates, we will face difficulty in obtaining product revenue in future periods, which could result in significant harm to our financial position and adversely affect our share price.
Even if we are successful in building our pipeline of product candidates, the potential product candidates that we identify may not be suitable for clinical development or generate acceptable clinical data, including as a result of being shown to have unacceptable toxicity or other characteristics that indicate that they are unlikely to be products that will receive marketing approval from the FDAFDA, EMA or other regulatory authorities or achieve market acceptance. If we do not successfully develop and commercialize product candidates, we will not be able to generate product revenue in the future, which likely would result in significant harm to our financial position and adversely affect our stock price.
We intend to develop IMM-1-104atebimetinib as a potential biologic/drug combination product, and we may also develop other current or future product candidates as biologic/drug combination products. Additional time may be required to obtain regulatory approval for any of our current or future product candidates if or when they are developed as potential combination products. Any of our product candidates that may be biologic/drug combination products will require coordination within the FDAFDA, EMA and other comparable foreign regulatory authorities for review of their biologic and drug components. Although the FDAFDA, EMA and other comparable foreign regulatory authorities have systems in place for the review and approval of combination products, we may experience delays in the development and commercialization of our product candidates that may be combination products due to regulatory timing constraints and uncertainties in the product development and approval process.
In addition, even if any product candidate we develop were to receive marketing approval or be commercialized for use in combination with other existing therapies, we would continue to be subject to the risks that the FDAFDA, EMA or comparable foreign regulatory authorities outside of the United States could revoke approval of the therapy used in combination with our product or that safety, efficacy, manufacturing or supply issues could arise with any of those existing therapies. If the therapies we use in combination with our product candidates are replaced as the standard of care for the indications we choose for any of our product candidates, the FDAFDA, EMA or comparable foreign regulatory authorities may require us to conduct additional clinical trials. The occurrence of any of these risks could result in our own products, if approved, being removed from the market or being less successful commercially.
We also may choose to evaluate our current product candidates or any other future product candidates in combination with one or more therapies that have not yet been approved for marketing by the FDAFDA, EMA or comparable foreign regulatory authorities. We will not be able to market and sell our product candidates we develop in combination with an unapproved therapy for a combination indication if that unapproved therapy does not ultimately obtain marketing approval either alone or in combination with our product. In addition, unapproved therapies face the same risks described with respect to our product candidates currently in development and clinical trials, including the potential for serious adverse effects, delay in their clinical trials and lack of FDAFDA, EMA or other regulatory approval.
If the FDAFDA, EMA or comparable foreign regulatory authorities do not approve these other drugs or revoke their approval of, or if safety, efficacy, quality, manufacturing or supply issues arise with, the drugs we choose to evaluate in combination with our product candidate we develop, we may be unable to obtain approval of or market such combination therapy.
Prior to seeking accelerated approval for any of our product candidates, we intend to seek feedback from the FDA and will otherwise evaluate our ability to seek and receive accelerated approval. There can be no assurance that after our evaluation of the feedback and other factors we will decide to pursue or submit an NDA for accelerated approval or any other form of expedited development, review or approval. Similarly, there can be no assurance that after subsequent FDA feedback we will continue to pursue or apply for accelerated approval or any other form of expedited development, review or approval, even if we initially decide to do so. Furthermore, if we decide to submit an application for accelerated approval or receive an expedited regulatory designation (e.g., breakthrough therapy designation) for our product candidates, there can be no assurance that such submission or application will be accepted or that any expedited development, review or approval will be granted on a timely basis, or at all. The FDAFDA, EMA or other comparable foreign regulatory authorities could also require us to conduct further studies prior to considering our application or granting approval of any type. A failure to obtain accelerated approval or any other form of expedited development, review or approval for our product candidate would result in a longer time period to commercialization of such product candidate, could increase the cost of development of such product candidate and could harm our competitive position in the marketplace.
Similar considerations exist with respect to the potential use of accelerated approval pathways in other jurisdictions outside of the United States.
Certain of our product candidates, including IMM-1-104 and IMM-6-415,atebimetinib, are based on the DCI of the MAPK pathway as a model of therapeutic intervention. Our DCI approach may not be viewed as distinct from other existing therapies targeting the MAPK pathway, and negative third party data from preclinical studies and/or clinical trials using other MAPK-targeted therapies could negatively impact the perception of the therapeutic use of such product candidates or products on the whole. This could, among other things, negatively impact our ability to enroll patients in clinical trials. The clinical and commercial success of our product candidates will depend in part on the public’s and clinical community’s acceptance of the use of DCI therapies. Moreover, our success depends upon physicians prescribing, and their patients being willing to receive, treatments that involve the use of product candidates we may develop in lieu of, or in addition to, existing treatments with which they are already familiar and for which greater clinical data may be available. Adverse events in our clinical trials, or those of our competitors or of academic researchers utilizing MAPK-targeted therapies, even if not ultimately similar or attributable to our DCI product candidates, and the resulting publicity, could result in increased governmental regulation, unfavorable public perception, increased volatility in our stock price, potential regulatory delays in the testing or approval of our potential product candidates, stricter labeling requirements for our product candidates that are approved, if any, and a decrease in demand for any such products, if approved.
We are early in our development efforts and we have not yet completed our Phase 1/2a clinical trialstrial for our lead product candidate IMM-1-104 or our second product candidate IMM-6-415.atebimetinib. Further, we have only disclosed interim data for IMM-1-104atebimetinib, and IMM-6-415.in April 2025 we paused further internal advancement of envometinib and the related Phase 1/2a clinical trial. Our other product candidates are in earlier stages of drug development. We have invested substantially all of our efforts and financial resources in the identification of targets, preclinical and clinical development of small molecules targeting the MAPK and other pathways in cancer therapy.
•the successful initiation, patient enrollment and completion on a timely basis of our ongoing and any future clinical trials that(including weour mayplanned initiate,registrational trial of atebimetinib in combination with mGnP in pancreatic cancer), despite any delays including those arising out of ongoing or future pandemics, or other widespread adverse health events;
Management's Discussion & Analysis (MD&A)
Largest changes
“Based on our current operating plan, we believe that we do not have sufficient cash and cash equivalents on hand to support current operations for at least one year from the date of issuance of the financial statements appearing within this Annual Report on Form 10-K. To finance our operations beyond that point, we will need to raise additional capital. There can be no assurance that we will be able to obtain additional funding on acceptable terms, if at all. …”see in full comparison
“Management considered whether or not there are conditions or events, in the aggregate, that raise substantial doubt about the entity’s ability to continue as a going concern, and concluded that there are none as it estimates that the entity's cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements for at least one year from the date of issuance of the financial statements appearing within this Annual Report on Form 10-K.”see in full comparison
“On August 21, 2025, we entered into a Securities Purchase Agreement (the "August 2025 Purchase Agreement") with the purchasers party thereto, pursuant to which we agreed to sell securities to such purchasers in a private placement (the “August 2025 Private Placement”). …”see in full comparison
“We sold 5,164,159 shares of common stock under our 2022 ATM Program (as defined below), at a weighted average price per share of $3.03, for aggregate gross proceeds of $15.6 million ($15.0 million net of offering expenses) during the year ended December 31, 2025. We did not sell any shares of common stock under our 2022 ATM Program during the three months ended December 31, 2025. We also did not sell any shares of common stock under our 2025 ATM Program (as defined below) during the three months or year ended December 31, 2025.”see in full comparison
Based on our currently forecasted operating plan, we believe that our existing cash, cash equivalents, andsee in full comparisoncashmarketableequivalentssecurities as of December 31,2024 and the $13.7 million net proceeds from the sale of Class A common stock through our ATM Program in January2025 will enable us to fund our operating expenses and capital expenditure requirements into2026.2029. Therefore, based on our recurring losses from operations incurred since inception, expectation of continuing operating losses for the foreseeable future and the need to raise additional capital to finance future operations, as of March20,6,2025,2026, the issuance date of the consolidated financial statements for the year ended December 31,20242025 included elsewhere in this Annual Report on Form 10-K, managementhasconsideredconcludedwhether or not there are conditions or events, in the aggregate, thatthere israise substantial doubt aboutourthe entity’s ability to continue as a goingconcernconcern, and concluded that there are none as it estimates that its cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements foraatperiodleastof12one yearmonths from the issuance date ofsuchthese consolidated financial statements.We are developing plans to mitigate this risk, which primarily consist of raising additional capital through some combination of equity or debt financings, and/or potentially new collaborations, business transactions, and reducing cash expenditures. If we are not able to secure adequate additional funding, we plan to make significant reductions in spending. In that event, we may have to delay, scale back, or eliminate some or all of our operations, sell assets or seek other strategic solutions.
“Pursuant to the September 2025 Purchase Agreement, we also agreed to (i) notify Aventis within three business days of us engaging in discussions with any third party regarding, or the board of directors authorizing us to pursue or initiate a process to pursue, any transaction that would be reasonably expected to result in a change of control of the Company or an affiliate of the Company (a “Change of Control”) or any other license, sale, assignment, transfer, grant or other disposition of the Company’s or an affiliate of the Company’s rights to research, develop, manufacture, commercialize …”see in full comparison
Full comparison: every changed paragraph (68)
We are a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive. We are developing and seeking to commercialize an entirely new category of anti-cancer medicines, Deep Cyclic Inhibitors, which we believe have the potential to be more effective and better tolerated targeted therapies.
WeDeep areCyclic Inhibition® ("DCI") is a clinical-stagenovel oncologymechanism companythat seekingaims to developdeprive andtumor commercializecells moreof effectivethe andsustained betterproliferative toleratedsignaling therapiesrequired for cancerrapid patients.growth, Wewhile aimsparing tohealthy achieve this goalcells through deepa cycliccadenced, inhibitionnormalized level of signaling. Our Deep Cyclic Inhibitors inhibit clinically-validated core signaling pathwayspathways, such as the MAPK pathway, impacting cancer cells while sparing healthy cells.pathway. Our inclusivenovel approach is designed to improve durability and tolerability, and differentiates us from chronically targeted precision therapies, which are generally limited by toxicity, resistance and/or application to specific mutations only.
Our lead product candidate, atebimetinib (IMM-1-104), is an oral, once-daily Deep Cyclic Inhibitor of MEK, designed to improve durability and tolerability across many cancer indications, including MAPK pathway-driven tumors such as pancreatic cancer. We are currently in the process of initiating a Phase 3 clinical trial of atebimetinib, which we call the MAPKeeper 301 trial, to evaluate atebimetinib in combination with mGnP in first-line pancreatic cancer patients. We expect to dose the first patient in the MAPKeeper 301 trial in mid-2026.
MAPKeeper 301 is designed as a global Phase 3 registrational trial that will evaluate atebimetinib (320 mg QD) in combination with mGnP, compared to standard of care GnP alone, in first-line metastatic PDAC. The primary endpoint of MAPKeeper 301 is overall survival, and secondary endpoints include progression-free survival, overall response rate, disease control rate, and quality of life measurements. We plan to enroll a total of approximately 510 patients in MAPKeeper 301, divided equally across the two arms.
In January 2026, we announced positive interim response and safety data from our ongoing Phase 2a clinical trial arm evaluating atebimetinib in combination with mGnP in first-line pancreatic cancer patients, which is part of our ongoing Phase 1/2a clinical trial of atebimetinib in patients with advanced solid tumors. We also announced that we expect the following near-term milestones related to atebimetinib: presenting further updated circulating tumor DNA data on acquired alterations from cancer patients treated with atebimetinib at a major scientific meeting, in the second quarter of 2026; announcing further updated survival data from over 50 first-line pancreatic cancer patients treated with atebimetinib in combination with mGnP in our ongoing Phase 1/2a clinical trial, in the first half of 2026; and dosing the first patient in a planned clinical trial of atebimetinib in combination with Libtayo® in non-small cell lung cancer patients, in the second half of 2026.
Our development pipeline also includes our additional clinical-stage product candidate envometinib (IMM-6-415) and other early-stage research programs, including research focused on validated core cancer-signaling pathways outside of the MAPK pathway.
We are currently evaluating our lead product candidate, IMM-1-104, in a Phase 1/2a clinical trial in patients with advanced solid tumors including those harboring RAS or RAF mutations. IMM-1-104 is being developed as a once-daily oral deep cyclic inhibitor of the MAPK signaling pathway, specifically at the level of MEK. IMM-1-104 is designed to improve tolerability and expand indications beyond currently registered MEK inhibitors to include RAS-driven tumors such as most pancreatic cancers.
Our second product candidate, IMM-6-415, aims to achieve broad activity with an accelerated twice-daily oral dosing cadence, also through deep cyclic inhibition of MEK.
Deep cyclic inhibition, or DCI, is a novel mechanism that aims to deprive tumor cells of the sustained proliferative signaling required for rapid growth, while sparing healthy cells through a cadenced, normalized level of signaling. This mechanism was engineered using our proprietary informatics-based discovery platform. The development of our pipeline is translationally guided by our proprietary, human-aligned 3D tumor modeling platform that we combine with bioinformatics-driven patient profiling, which we believe has the potential to increase the probability of success in clinical development versus traditional drug development approaches. Our pipeline also includes a discovery program targeting RAS, an undisclosed target, and other small molecule drug discovery programs.
In September 2022, the FDA cleared our IND application for IMM-1-104 and, in November 2022, we commenced dosing in our Phase 1/2a clinical trial of IMM-1-104 for the potential treatment of patients with advanced solid tumors including those harboring RAS mutations. The Phase 2a portion includes evaluating IMM-1-104 in multiple dose expansion and combination arms. We began dosing the Phase 2a cohorts in March 2024.
In January 2025, we announced positive interim response and safety data from three Phase 2a pancreatic cancer arms of the IMM-1-104 clinical trial, as well as our plans to initiate additional Phase 2a arms of IMM-1-104 in combination with a BRAF inhibitor for melanoma, in combination with a KRAS G12C inhibitor in non-small cell lung cancer, and in combination with checkpoint inhibitors for both melanoma and non-small cell lung cancer. Additional data from the Phase 2a portion of the trial is expected in the second quarter of 2025.
In December 2023, the FDA cleared our IND application for IMM-6-415 and, in March 2024, we commenced dosing in our Phase 1/2a clinical trial of IMM-6-415 for the potential treatment of patients with advanced solid tumors harboring RAF or RAS mutations. The Phase 1/2a clinical trial is designed to assess the safety, tolerability, PK, PD, and preliminary anti-tumor activity of IMM-6-415. The Phase 1 portion of the clinical trial includes dose escalation and dose exploration for IMM-6-415, using a mTPI-2 statistical design to establish an optimized RP2D in solid tumor patients with evidence of any RAF or RAS mutation. The Phase 2a portion includes evaluating IMM-6-415 in multiple dose expansion arms.
In January 2025, we announced initial interim PK, PD and safety data from the Phase 1 portion of the ongoing IMM-6-415 Phase 1/2a clinical trial. In February 2025, we paused further patient enrollment in the IMM-6-415 Phase 1/2a clinical trial in order to evaluate the data from patients being treated at the 120 mg dose level and determine next steps for the program.
For the period from inception through 2017, we devoted substantially all of our efforts to business planning, service revenue generation, developing tools to aid in drug discovery, and recruiting management and technical staff. Since 2018, we have focused significant effort on our own internal research and development programs, and since December 2022 have exclusively focused our efforts on such programs. We have financed our operations through service revenues (which have since ceased), the issuance of convertible debt and the sale of convertible preferred stock, common stock and warrants exercisable for common stock.
On December 22, 2021, we completed the acquisition of all outstanding shares of capital stock of BioArkive, Inc., a California corporation (“BioArkive”) for a market value of $8.75 million.
On December 22, 2021, we completed the acquisition of all outstanding shares of capital stock of BioArkive, Inc., a California corporation (“BioArkive”), for a market value of $8.75 million. BioArkive was a San Diego based contract research organization that previously provided preclinical research services and biosample storage to us and other biotechnology companies. BioArkive was fully integrated into our operations following the acquisition and now exclusively supports our internal preclinical research activities for our oncology pipeline. In connection with the acquisition, we assumed the obligations under BioArkive’s three lease agreements.agreement obligations.
We sold 5,164,159 shares of common stock under our 2022 ATM Program (as defined below), at a weighted average price per share of $3.03, for aggregate gross proceeds of $15.6 million ($15.0 million net of offering expenses) during the year ended December 31, 2025. We did not sell any shares of common stock under our 2022 ATM Program during the three months ended December 31, 2025. We also did not sell any shares of common stock under our 2025 ATM Program (as defined below) during the three months or year ended December 31, 2025.
On August 21, 2025, we entered into a Securities Purchase Agreement (the "August 2025 Purchase Agreement") with the purchasers party thereto, pursuant to which we agreed to sell securities to such purchasers in a private placement (the “August 2025 Private Placement”). The August 2025 Purchase Agreement provided for the sale and issuance by us to the purchasers of: (i) an aggregate of 5,251,349 shares of our common stock at a purchase price of $3.95 per share, (ii) for certain purchasers, in lieu of common stock, an aggregate of 1,077,764 pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to the same number of shares of our common stock, and (iii) an aggregate of 2,848,096 warrants (the “Purchase Warrants”) to purchase up to the same number of shares of our common stock. The Pre-Funded Warrants were issued for a purchase price equating to $3.949 per Pre-Funded Warrant (which was the per share purchase price for the common stock issued in the August 2025 Private Placement, less the $0.001 per share unfunded exercise price for each Pre-Funded Warrant); following the October 2025 Cashless Exercise (as defined below), no Pre-Funded Warrants remained issued and outstanding. The Purchase Warrants were issued with an exercise price of $5.50 per share; as of December 31, 2025, no Purchase Warrants had been exercised. As of December 31, 2025, we had received aggregate net proceeds of $23.4 million from the August 2025 Private Placement, after deducting placement expenses of $1.6 million. The August 2025 Private Placement closed on August 26, 2025.
On September 24, 2025, we entered into a Securities Purchase Agreement (the "September 2025 Purchase Agreement") with Aventis Inc. ("Aventis"), a wholly owned subsidiary of Sanofi, a French société anonyme ("Sanofi"), pursuant to which we agreed to sell securities to Aventis in a private placement (the “September 2025 Private Placement”). The September 2025 Purchase Agreement provided for the sale and issuance by us to Aventis of an aggregate of 2,708,559 shares of our common stock at a purchase price of $9.23 per share. We received aggregate net proceeds of $23.4 million from the September 2025 Private Placement, after deducting placement agent discounts and commissions of $1.5 million and placement costs of $0.1 million. The September 2025 Private Placement closed on September 26, 2025.
On AprilSeptember 20,26, 2023,2025, we completed an underwritten follow-on equity offering, pursuant to which we issued and sold 2,727,27318,959,914 shares of our Class A common stock at an offering price of $11.00$9.23 per share.share (the "September 2025 Offering"), with Leerink Partners LLC and Oppenheimer & Co. Inc. acting as underwriters. The aggregate net proceeds received by us from the offeringSeptember 2025 Offering were $28.2$164.1 million, after deducting underwriting discounts and commissions, butas beforewell deductingas offering costs payableof by us, which were $0.2$0.4 million.
During the twelve months ended December 31, 2024, we sold 1,318,752 shares of Class A common stock through our “at the market” equity offering program ("ATM Program"), at an average price per share of $3.27, for aggregate gross proceeds of $4.5 million ($4.2 million net of offering expenses). In January 2025, we sold an additional 4,836,804 shares of Class A common stock through our ATM Program, at an average price per share of $2.95, for aggregate gross proceeds of $14.2 million ($13.7 million net of offering expenses).
Since our inception, we have had significant annual operating losses. Our net loss was approximately $61.0$56.0 million and $53.5$61.0 million for the years ended December 31, 20242025 and 2023,2024, respectively. As of December 31, 2024,2025, we had an accumulated deficit of approximately $224.3$280.3 million and approximately $36.1$217.0 million in cash, cash equivalents, and cashmarketable equivalents.securities.
Based on our current business plans, we believe that our existing cash, cash equivalents, and cashmarketable equivalentssecurities as of December 31, 2024 and the $13.7 million net proceeds from the sale of Class A common stock through our ATM Program in January 2025 will enable us to fund our development activities and other operations into 2026.2029. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. To finance our operations beyond that point we will need to raise additional capital, which cannot be assured. We may be unable to raise additional funds or enter into such other arrangements when needed or on favorable terms, if at all. Any failure to raise capital as and when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies, including our research and development activities. If we are unable to raise capital, we will need to delay, reduce or terminate some or all planned activities to reduce costs.
As of March 6, 2026, the issuance date of the consolidated financial statements for the year ended December 31, 2025 in this Annual Report on Form 10-K, based on our recurring losses from operations incurred since inception, expectation of continuing operating losses for the foreseeable future and the need to raise additional capital to finance future operations, we believe that our existing cash, cash equivalents, and marketable securities will enable us to fund our development activities and other operations into 2029. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. To finance our operations beyond that point we will need to raise additional capital, which cannot be assured.
Our operating expenses consist of: (i) research and development expensesexpenses, and (ii) general and administrative expenses.
•program specific expenses incurred under agreements with third-party CROs and other vendors that conduct our preclinical and clinical activities on our behalf, including clinical trial sites that conduct research and development activities on our behalf;
•facility and equipment related expenses, consisting of indirect and allocated expenses for rent, depreciation,depreciation and amortization, maintenance of facilities, insurance, and other supplies.
Our direct research and development expenses are tracked on a program-by-program basis once they are in Phase 1 and consist of external costs and fees paid to consultants, contractors, CMOs,CMOs and CROs in connection with our preclinical and clinical development and manufacturing activities. Such program costs also include the external costs of laboratory and consumable materials and costs of raw materials that are directly attributable to and incurred for any single program. We do not allocate employee costs, contractor/consultant fees, costs associated with our platform development and discovery efforts, payments made under third-party licensing agreements, costs of laboratory supplies and consumable materials that are not directly attributable to any single program, and facilities expenses, including rent, depreciation/amortization, and other indirect costs, to specific product development programs because these costs are deployed across multiple programs and our platform technology and, as such, are not separately classified.
•maintenance of a continued acceptable safety profile of our productsproduct candidates following receipt of any marketing approvals, if any.
We may never succeed in achieving regulatory approval for any of our product candidates. Further, a number of factors, including those outside of our control, could adversely impact the timing and duration of our product candidates’ development, which could increase our research and development expense.expenses. We may obtain unexpected results from our preclinical studies and clinical trials. We may elect to discontinue, delay or modify clinical trials of some product candidates or focus on others. A change in the outcome of any of these factors could mean a significant change in the costs and timing associated with the development of our current and future preclinical and clinical product candidates. For example, if the FDAFDA, EMA or another regulatory authority were to require us to conduct clinical trials beyond those that we currently anticipate will be required for the completion of clinical development, or if we experience significant delays in execution of or enrollment in any of our preclinical studies or clinical trials, we could be required to expend significant additional financial resources and time on the completionadvancement of preclinical and clinical development.
We expect that our research and development expenses will substantially increase for the foreseeable future as we continue to implement our business strategy, which includes: advancing our product candidates through clinical development,development (including atebimetinib in our MAPKeeper 301 Phase 3 clinical trial), expanding our research and development efforts, including hiring additional personnel to support our research and development efforts, and seeking regulatory approvals for our product candidates that successfully complete clinical trials. In addition, product candidates in later stages of clinical development generally incur higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. As a result, we expect our research and development expenses to increase as our product candidates advance into later stages of clinical development. As of the date of this Annual Report on Form 10-K, we cannot reasonably determine or accurately project total program-specific expenses through commercialization, if such werewas to occur. There are numerous factors associated with the 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.
We expect our general and administrative expenses will increase for the foreseeable future if and as we continue to increase our general and administrative headcount to support our continued research and development activities and, if any product candidates receive marketing approval, commercialization activities, as well as to support our operations generally. As we expand our operations, weWe also expect to continue to incur increased expenses associated with operating as a public company, including costs related to accounting, audit, legal, regulatory, and tax-related services associated with maintaining compliance with exchange listing and rules and regulations of the Securities and Exchange Commission (“SEC”), Sarbanes-Oxley Act, director and officer insurance costs, and investor and public relations costs.
Research and development expenses increaseddecreased by approximately $6.3$5.9 million, or 15.2%,12.3%, to approximately $42.0 million for the year ended December 31, 2025 as compared to approximately $48.0 million for the year ended December 31, 2024 as compared to approximately $41.6 million for the year-ended December 31, 2023.2024. The increasedecrease of approximately $6.3$5.9 million was primarily due to ana increasedecrease of approximately $6.8$5.0 million related to direct research and development expenses, consisting of: aan $8.8approximately $0.5 million increasedecrease in expenses related to the IMM-1-104atebimetinib programprogram, primarily driven by a decrease in certain chemistry, tablet and asafety $1.4study costs, offset by increased costs related to Phase 3 clinical trial initiation; an approximately $4.3 million increasedecrease in expenses related to the IMM-6-415paused program,envometinib offsetprogram; byand aan $3.4approximately $0.2 million decrease in expenses for earlier stage and neuroscience programsprograms, as compared to the same prior year period,period. The overall decrease in research and development expenses was additionally driven by a decrease in unallocatedindirect research and development costs of approximately $0.5$1.0 million, primarily driven by decreased employee-related costs of $0.7approximately $0.9 million, offsetand bydecreased a $0.2 million increase related to stock compensation expense, depreciation, facilities,facilities and other allocated expenses inof aggregate.approximately $0.1 million.
General and administrative expenses decreasedincreased by approximately $0.7$1.2 million, or 4.1%,7.6%, to approximately $17.3 million for the year ended December 31, 2025 compared to approximately $16.1 million for the year ended December 31, 2024 compared to approximately $16.8 million for the year ended December 31, 2023.2024. The decreaseincrease of approximately $0.7$1.2 million was primarily due to: decreasedincreased employee-related costs of $0.5approximately million,$0.7 decreasedmillion; increased professional fees incurred for accounting, auditing, legal, public relations and tax services of approximately $0.7$0.5 million,million; and decreased facilities andincreased other expenses (primarily consisting of offering costs associated with various financing efforts) of approximately $0.1$0.3 million in the aggregate; this decrease wasmillion, offset by ana increasedecrease in stock-based compensation of approximately $0.7$0.2 million.
Amortization of intangible asset was $29 thousand for the years ended December 31, 20242025 and 2023.2024. This amortization is related to the technology acquired forfrom the BioArkive acquisition completed in December 2021.
Interest income from the interest earned on our cash, cash equivalents and marketable securities balances decreasedincreased by approximately $1.0$0.4 million, driven by lower interest rates and a lowerhigher total cash balance,balance resulting from various financing events, in the year ended December 31, 20242025 as compared to the year ended December 31, 2023.2024.
Other income, net was approximately $0.3 million in the year ended December 31, 2025, compared to $0.4 million in the year ended December 31, 2024,2024. comparedThese toamounts $1.3 million in the year ended December 31, 2023. This waswere primarily a result of the increase in the accretion of premiums related to our marketable securities.
We finance our operations through the issuance of convertible notes payable, convertible preferred stock, common stock, warrants exercisable for common stock and the exercise of stock options. As of December 31, 2024,2025, we had an accumulated deficit of $224.3$280.3 million and $36.1$217.0 million in cash and cash equivalents. Cash andcash, cash equivalents and marketable securities. Cash, cash equivalents and marketable securities are comprised of deposits at major financial banking institutions and highly liquid investments with an original maturity of three months or less at the date of purchase. Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures, and to a lesser extent, general and administrative expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, reflected in the change in our outstanding accounts payable and accrued expenses.
Since our inception, we have incurred significant operating losses. Our net loss was approximately $61.0$56.0 million and $53.5$61.0 million for the years ended December 31, 20242025 and 2023,2024, respectively. We have not yet commercialized any of our product candidates, and we do not expect to generate revenue from sales of any product candidates for the next several years, if at all. To date, our operations have been financed primarily by service revenues (which have since ceased) and proceeds from sales of our debt and equity securities.
On August 10, 2022, we filed a Registration Statement on Form S-3 (File No. 333-266738) (the “2022 Shelf Registration Statement”) with the SEC in relation to the registration of our common stock, preferred stock, debt securities, warrants and/or units or any combination thereof in the aggregate amount of up to $200 million for a period of up to three years from the date of its effectiveness on August 19, 2022.
OnAlso on August 10, 2022, we entered into an Equity Distribution Agreement (the "2022 Sales Agreement") with Piper Sandler & Co,Co (the "Sales Agent"), to sell shares of our common stock with aggregate gross proceeds of up to $50 million, from time to time, through ouran "at the market" equity offering program (the "2022 ATM Program.Program") under the 2022 Shelf Registration Statement. We didsold not sell any5,164,159 shares of Class A common stock under the 2022 ATM ProgramProgram, at an weighted average price per share of $3.03, for aggregate gross proceeds of $15.6 million ($15.0 million net of offering expenses) during the year ended December 31, 2023.2025. We sold 1,318,752 shares of Class A common stock under the 2022 ATM Program,program, at ana weighted average price per share of $3.27,$3.38, for aggregate gross proceeds of $4.5 million ($4.2 million net of offering expenses) during the year ended December 31, 2024. InWe Januarydid 2025,not wesell sold an additional 4,836,804any shares of Class A common stock under the 2022 ATM Program,Program atduring anthe averagethree pricemonths perended shareDecember of31, $2.95,2025 foror aggregateDecember gross31, proceeds2024, ofrespectively. $14.2In millionAugust ($13.72025, millionthe net2022 ofShelf offeringRegistration expenses).Statement and the 2022 ATM Program expired, and the 2022 Sales Agreement was terminated.
On August 13, 2025, we filed a Registration Statement on Form S-3 (File No. 333-289589) (the “2025 Shelf Registration Statement”) with the SEC in relation to the registration of our common stock, preferred stock, debt securities, warrants and/or units or any combination thereof in the aggregate amount of up to $300 million for a period of up to three years from the date of its effectiveness on August 20, 2025.
Also on August 13, 2025, we entered into an Equity Distribution Agreement (the "2025 Sales Agreement") with the Sales Agent, to sell shares of our common stock with aggregate gross proceeds of up to $100 million, from time to time, through an "at the market" equity offering program (the "2025 ATM Program") under the 2025 Shelf Registration Statement. In connection with the September 2025 Offering, we: (i) reduced the maximum aggregate offering price for sales of shares of common stock pursuant to at-the-market transactions under the 2025 ATM Program by $1,250,007 (the "Reduced Amount"), resulting in a new maximum aggregate offering price of up to $98,749,993 under the 2025 ATM Program, and (ii) suspended the 2025 ATM Program and terminated the continuous offering under the 2025 ATM Program, in each case, as to the Reduced Amount. We did not sell any shares of common stock under the 2025 ATM Program during the three and twelve months ended December 31, 2025 or December 31, 2024, respectively.
On August 21, 2025, we entered into the August 2025 Purchase Agreement with the purchasers party thereto, pursuant to which we agreed to sell securities to such purchasers in the August 2025 Private Placement. The August 2025 Purchase Agreement provided for the sale and issuance by us to the purchasers of: (i) an aggregate of 5,251,349 shares of our common stock at a purchase price of $3.95 per share, (ii) for certain purchasers, in lieu of common stock, an aggregate of 1,077,764 Pre-Funded Warrants to purchase up to the same number of shares of our common stock, and (iii) an aggregate of 2,848,096 Purchase Warrants to purchase up to the same number of shares of our common stock. The Pre-Funded Warrants were issued for a purchase price equating to $3.949 per Pre-Funded Warrant (which was the per share purchase price for the common stock issued in the August 2025 Private Placement, less the $0.001 per share unfunded exercise price for each Pre-Funded Warrant). On October 6, 2025, certain purchasers from the August 2025 Private Placement exercised an aggregate of 1,077,764 Pre-Funded Warrants previously issued to them pursuant to the August 2025 Purchase Agreement. Each such exercise was made pursuant to the cashless exercise provision of the applicable Pre-Funded Warrant, such that an aggregate of 166 shares of common stock were withheld in lieu of cash payment of the $0.001 exercise price for each Pre-Funded Warrant share, and the exercising purchasers were issued an aggregate of 1,077,598 shares of common stock (the "October 2025 Cashless Exercise"). Following the October 2025 Cashless Exercise, no Pre-Funded Warrants remained issued and outstanding. The Purchase Warrants were issued with an exercise price of $5.50 per share; as of December 31, 2025, no Purchase Warrants had been exercised. As of December 31, 2025, we had received aggregate net proceeds of $23.4 million from the August 2025 Private Placement, after deducting placement expenses of $1.6 million. The August 2025 Private Placement closed on August 26, 2025.
Also on August 21, 2025, in connection with the August 2025 Purchase Agreement, we entered into a Registration Rights Agreement (the “Registration Rights Agreement”) with the purchasers in the August 2025 Private Placement. Pursuant to the Registration Rights Agreement, we agreed to prepare and file a registration statement with the SEC for purposes of registering the resale of the common stock and the shares of common stock issuable upon exercise of the Pre-Funded Warrants and Purchase Warrants (collectively, the “Warrant Shares”) purchased by the purchasers in the August 2025 Private Placement, and any shares of common stock issued as a dividend or other distribution with respect to, in exchange for or in replacement of such common stock or Warrant Shares. On September 3, 2025, we filed a Registration Statement on Form S-3 (File No. 333-289997) (the “2025 Resale Registration Statement”) with the SEC in relation to the registration for re-sale of the common stock and Warrant Shares from the August 2025 Private Placement. The SEC declared the 2025 Resale Registration Statement effective on September 8, 2025.
The foregoing and other related summaries contained herein do not purport to be complete and are qualified in their entirety by reference to the August 2025 Purchase Agreement, the Registration Rights Agreement, the Pre-Funded Warrants and the Purchase Warrants, which are filed as Exhibits 10.18, 10.19, 4.4 and 4.5, respectively, to this Annual Report on Form 10-K.
On September 24, 2025, we entered into the September 2025 Purchase Agreement with Aventis, a wholly owned subsidiary of Sanofi, pursuant to which we agreed to sell securities to Aventis in the September 2025 Private Placement. The September 2025 Purchase Agreement provided for the sale and issuance by us to Aventis of an aggregate of 2,708,559 shares of our common stock at a purchase price of $9.23 per share. We received aggregate net proceeds $23.4 million from the September 2025 Private Placement, after deducting placement agent discounts and commissions of $1.5 million and placement costs of $0.1 million. The September 2025 Private Placement closed on September 26, 2025.
Pursuant to the September 2025 Purchase Agreement, we also agreed to (i) notify Aventis within three business days of us engaging in discussions with any third party regarding, or the board of directors authorizing us to pursue or initiate a process to pursue, any transaction that would be reasonably expected to result in a change of control of the Company or an affiliate of the Company (a “Change of Control”) or any other license, sale, assignment, transfer, grant or other disposition of the Company’s or an affiliate of the Company’s rights to research, develop, manufacture, commercialize, or otherwise exploit atebimetinib (a “Covered Transaction” and, collectively, a “Strategic Transaction Process”), (ii) provide Aventis the opportunity to participate in such Strategic Transaction Process subject to customary confidentiality and other undertakings on substantially the same procedural terms and timeframe as other participants, and (iii) for a period of 120 days following the date of the September 2025 Purchase Agreement, not enter into any Covered Transaction or commence, continue, or otherwise engage in any discussions, or negotiate with any third party, to enter into any Covered Transaction (provided that this provision shall not limit the entry by us into, or any engagement in discussion or negotiations with any third party regarding, a Change of Control transaction). These provisions contain customary confidentiality restrictions and limitations on disclosure obligations, and will terminate upon the earlier of: (a) such time as Aventis and its affiliates no longer hold at least 50% of the securities purchased from the Company pursuant to the September 2025 Purchase Agreement, (b) 90 days after the public release of the topline results of the overall survival of the Phase 3 clinical trial of atebimetinib in pancreatic cancer, (c) the liquidation, dissolution or winding-up of the affairs of the Company, or the consummation of any Change of Control or any other deemed liquidation event of the Company and (d) such time as all development activities with respect to atebimetinib have been terminated.
In addition, pursuant to the September 2025 Purchase Agreement, Aventis agreed (i) until the date that is six months after the closing date of the September 2025 Private Placement, to be subject to customary lock-up restrictions with respect to sales of shares of our common stock (or similar transactions with the same economic effect), subject to certain customary exceptions, (ii) until the first anniversary of the closing date of the September 2025 Private Placement, to be subject to stand-still restrictions with respect to acquisitions of shares of the our common stock and similar activities, subject to certain customary exceptions and fall-away provisions, and (iii) until the first anniversary of the closing date of the September 2025 Private Placement or such earlier time as the stand-still restrictions shall have fallen away, vote with respect to all voting securities of the Company as to which it is entitled to vote in accordance with the recommendation of a majority of our board of directors.
The foregoing and other related summaries contained herein do not purport to be complete and are qualified in their entirety by reference to the September 2025 Purchase Agreement, which is filed as Exhibit 10.20 to this Annual Report on Form 10-K.
On AprilSeptember 20,26, 2023,2025, we completed anthe underwrittenSeptember follow-on2025 equity offering,Offering, pursuant to which we issued and sold 2,727,27318,959,914 shares of our Class A common stock at an offering price of $11.00$9.23 per share.share, with Leerink Partners LLC and Oppenheimer & Co. Inc. acting as underwriters. The aggregate net proceeds received by us from the offeringSeptember were2025 $28.2Offering $164.1 million, after deducting underwriting discounts and commissions, butas beforewell deductingas offering costs payableof by us, which were $0.2$0.4 million.
As of December 31, 2024,2025, we havehad contractual obligations related to various leases of $0.7 million for 2025, $0.8 million for 2026, $0.8 million for 2027, $0.8 million for 2028, $0.8 million for 20292029, $0.9 million for 2030 and $2.0$1.2 million for the periods thereafter.
Based on our current business plans, we believe that our existing cash, cash equivalents, and cashmarketable equivalentssecurities as of December 31, 2024 and the $13.7 million net proceeds from the sale of Class A common stock through our ATM Program in January 2025 will enable us to fund our development activities and other operations into 2026.2029. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. To finance our operations beyond that point we will need to raise additional capital, which cannot be assured. We may be unable to raise additional funds or enter into such other arrangements when needed or on favorable terms, if at all. Any failure to raise capital as and when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies, including our research and development activities. If we are unable to raise capital, we will need to delay, reduce or terminate some or all planned activities to reduce costs.
Management considered whether or not there are conditions or events, in the aggregate, that raise substantial doubt about the entity’s ability to continue as a going concern, and concluded that there are none as it estimates that the entity's cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements for at least one year from the date of issuance of the financial statements appearing within this Annual Report on Form 10-K.
Based on our current operating plan, we believe that we do not have sufficient cash and cash equivalents on hand to support current operations for at least one year from the date of issuance of the financial statements appearing within this Annual Report on Form 10-K. To finance our operations beyond that point, we will need to raise additional capital. There can be no assurance that we will be able to obtain additional funding on acceptable terms, if at all. We have concluded that this circumstance raises substantial doubt about our ability to continue as a going concern for at least one year from the date of the issuance of our consolidated financial statements for the period ended December 31, 2024. We intend to obtain additional funding through available financing sources which may include additional public offerings of common stock, private financing of debt or equity, and / or the pursuit of strategic partnerships, licensing arrangements or collaborations to fund our future operations and remain as a going concern. To the extent that we raise additional capital through future equity offerings, the ownership interest of common stockholders will be diluted, which may be significant. See Note 1 - Organization and Nature of Business to our consolidated financial statements in this Annual Report on Form 10-K for additional information on our assessment. Until such time as we can generate revenue from product sales, if ever, we expect to finance our cash needs through a combination of equity offerings, debt financings, and potential collaborations, license and development agreements.
During the year ended December 31, 2024,2025, operating activities used approximately $55.0$45.3 million of cash, primarily resulting from our net loss of approximately $61.0$56.0 million, changes in our operating assets and liabilities of $0.9 million,million and net amortization of premium (accretion of discount) on marketable securities of $0.3$0.2 million, partially offset by stock-based compensation expense of approximately $6.5$6.3 millionmillion, changes in our operating assets and liabilities of $3.8 million, and $0.7 million for the reduction in carrying amount of right-of-use assets and depreciation.depreciation and amortization.
During the year ended December 31, 2023,2024, operating activities used approximately $49.0$55.0 million of cash, primarily resulting from our net loss of approximately $53.5$61.0 million, changes in our operating assets and liabilities of $1.0$0.9 million, and net amortization of premium (accretion of discount) on marketable securities of $1.0$0.3 million, partially offset by stock-based compensation expense of approximately $5.7$6.5 million and $0.7 million for the reduction in carrying amount of right-of-use assets and depreciation.depreciation and amortization.
During the year ended December 31, 2024,2025, cash providedused from investing activities was approximately $26.4$88.7 million, primarily related to maturities of marketable securities of $31.9 million, offset by purchases of marketable securities of $5.4$88.6 million and $0.1 million for purchases of property and equipment.
During the year ended December 31, 2024,2025, net cash provided by financing activities was approximately $5.3$226.6 million, primarily driven by proceeds of approximately: $4.2$15.0 million from the issuancesale of Class A common stock under our 2022 ATM program, net of offeringcommissions; expenses,$0.4 inmillion additionfrom the sale of common stock pursuant to $0.7our employee stock purchase plan; $0.4 million from the exercise of stock options; and approximately $0.4$25.0 million from ourthe employeesale of common stock, Pre-Funded Warrants and Purchase Warrants in the August 2025 Private Placement; $25.0 million from the sale of common stock purchasein plan.the September 2025 Private Placement; and $164.5 million from the sale of common stock in the September 2025 Offering, net of underwriting commissions. The above were partially offset by aggregate payments of offering and placement expenses, as applicable, of $3.7 million.
During the year ended December 31, 2023,2024, net cash provided by financing activities was approximately $28.4$5.3 million, primarily driven by net proceeds, after deducting commissions and underwriting fees,proceeds of approximately $28.2$4.2 million from the sale of common stock under our underwritten2022 follow-onATM equityprogram, net of offering in April 2023,expenses, in addition to $0.4$0.7 million from the exercise of stock options,options offsetand byapproximately $0.2$0.4 million infrom paymentsour ofemployee costsstock relatedpurchase to the follow-on equity offering.plan.
What changed in the latest 10-Q
Risk Factors
Largest changes
We have incurred net losses in each reporting period for the past several years, have not generated any revenue from product sales to date and have financed our operations principally through our historical computational biology services to pharmaceutical and biotechnology companies (which have since ceased), the issuance of convertible debt and the sale of our convertible preferred stock, Class A common stock and warrants exercisable for common stock. We have incurred net losses of approximatelysee in full comparison$13.5$30.7 million and $56.0 million for thethreesix months endedMarchJune31,30, 2026 and year ended December 31, 2025, respectively. As ofMarchJune31,30, 2026, we had an accumulated deficit of approximately$293.8$311.1 million. Our losses have resulted principally from expenses incurred in research and development of our product candidates, from management and administrative costs and from other expenses that we have incurred while building our business infrastructure. We are currently conductingan ongoing Phase 1/2aclinicaltrialtrials for our product candidate atebimetinib for the treatment of advanced solidtumors and plan to dose the first patient in our MAPKeeper 301 registrational trial in mid-2026.tumors. Our other product candidates are in earlier stages of drug development. As a result, we expect that it will be several years, if ever, before we have a commercialized product and generate revenue from product sales. 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 as we discover, develop and market additional potential product candidates.
see in full comparisonWeOurcurrently have limitedcurrent internationaloperations,operations relate primarily to clinical trial activities, but our business plans incorporate potential international expansion, for example including theplanned addition of international clinical trial sites,potential engagement with a collaborator based internationally, orifupon any of our product candidatesreceivesreceiving regulatoryapproval.approval (which may never occur). Doing business internationally involves a number of risks, including but not limited to:
Wesee in full comparisonintend toconduct clinical trial operations at U.S. and internationalclinical trials in the future.sites. The acceptance of study data from clinical trials conducted outside the U.S. or another jurisdiction by the FDA or comparable foreign regulatory authority may be subject to certain conditions or may not be accepted at all. In cases where data from foreign clinical trials are intended to serve as the sole basis for marketing approval in the U.S., the FDA will generally not approve the application on the basis of foreign data alone unless (i) the data are applicable to the U.S. population and U.S. medical practice; (ii) the trials were performed by clinical investigators of recognized competence and pursuant to GCP regulations; and (iii) the data may be considered valid without the need for an on-site inspection by the FDA, or if the FDA considers such inspection to be necessary, the FDA is able to validate the data through an on-site inspection or other appropriate means. In addition, even where the foreign study data are not intended to serve as the sole basis for approval, the FDA will not accept the data as support for an application for marketing approval unless the study is well-designed and well-conducted in accordance with GCP requirements and the FDA is able to validate the data from the study through an onsite inspection if deemed necessary. Many foreign regulatory authorities have similar approval requirements. In addition, such foreign trialswould beare subject to the applicable local laws of the foreign jurisdictions where the trials are conducted. There can be no assurance that the FDA or any comparable foreign regulatory authority will accept data from trials conducted outside of the U.S. or the applicable jurisdiction. If the FDA or any other comparable foreign regulatory authority does not accept such data, it could result in the need for additional trials, which would be costly and time-consuming and delay aspects of our business plan, and which may result in our current or future product candidates not receiving approval for commercialization in the applicable jurisdiction.
Full comparison: every changed paragraph (18)
Pharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk. We are a late-stage clinical oncology company with a limited operating history in developing pharmaceutical products which makes it difficult to evaluate our business and prospects in future product development. We have no products approved for commercial sale and have not generated any revenue from product sales. To date, we have devoted substantially all of our resources and efforts to providing computational biology services to pharmaceutical and biotechnology companies, organizing and staffing our company, business planning, executing partnerships, raising capital, discovering, identifying and developing potential product candidates, securing related intellectual property rights and undertaking research and preclinical studies and clinical trials of our product candidates, including our ongoing Phase 1/2a clinical trialtrials of atebimetinib (also referred to as IMM-1-104) for the treatment of advanced solid tumors. We have not yet demonstrated our ability to successfully complete any registrational clinical trials, obtain marketing approvals, manufacture a commercial-scale product or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization. As a result, it may be more difficult for you to accurately predict our future success or viability to develop new pharmaceutical products than it could be if we had a longer operating history.
We have incurred net losses in each reporting period for the past several years, have not generated any revenue from product sales to date and have financed our operations principally through our historical computational biology services to pharmaceutical and biotechnology companies (which have since ceased), the issuance of convertible debt and the sale of our convertible preferred stock, Class A common stock and warrants exercisable for common stock. We have incurred net losses of approximately $13.5$30.7 million and $56.0 million for the threesix months ended MarchJune 31,30, 2026 and year ended December 31, 2025, respectively. As of MarchJune 31,30, 2026, we had an accumulated deficit of approximately $293.8$311.1 million. Our losses have resulted principally from expenses incurred in research and development of our product candidates, from management and administrative costs and from other expenses that we have incurred while building our business infrastructure. We are currently conducting an ongoing Phase 1/2a clinical trialtrials for our product candidate atebimetinib for the treatment of advanced solid tumors and plan to dose the first patient in our MAPKeeper 301 registrational trial in mid-2026.tumors. Our other product candidates are in earlier stages of drug development. As a result, we expect that it will be several years, if ever, before we have a commercialized product and generate revenue from product sales. 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 as we discover, develop and market additional potential product candidates.
•advance the development of our current and future product candidates, including atebimetinib, through preclinical and clinical development, and, if approved by the FDAFDA, EMA or other comparable foreign regulatory authorities, commercialization;
To become and remain profitable, we must succeed in developing and eventually commercializing product candidates that generate significant revenue. This will require us to be successful in a range of challenging activities, including completing preclinical studies and clinical trials of our product candidates, discovering additional product candidates, obtaining regulatory approval for these product candidates, manufacturing, marketing and selling any products for which we may obtain regulatory approval, achieving market acceptance of any such approved products and receiving reimbursements in amounts above our costs. We are only in the preliminary stages of most of these activities. We may never succeed in these activities and, even if we do, we may never generate revenue that is significant enough to achieve profitability. Because of the numerous risks and uncertainties associated with pharmaceutical product candidate development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve profitability. If we are required by the FDAFDA, EMA or other regulatory authorities to perform preclinical studies or clinical trials in addition to those currently expected, or if there are any delays in completing our ongoing preclinical studies or clinical trials or the development of any of our product candidates, our expenses could increase and revenue could be further delayed. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would depress our value and could impair our ability to raise capital, expand our business, maintain our research and development efforts, diversify our product offerings or even continue our operations.
Developing pharmaceutical products, including conducting preclinical studies and clinical trials, is a very time-consuming, expensive and uncertain process that takes years to complete. Our operations have consumed substantial amounts of cash since inception, and we expect our expenses to increase in connection with our ongoing activities, particularly as we initiate and conduct preclinical studies and clinical trials, including any registrational trials, and seek marketing approval for our current and any future product candidates. Even if one or more of the product candidates that we develop is approved for commercial sale, we anticipate incurring significant costs associated with commercializing any approved product candidate. Our expenses could increase beyond expectations if we are required by the FDAFDA, EMA or other comparable foreign regulatory authorities to perform clinical trials or preclinical studies in addition to those that we currently anticipate. Other unanticipated costs may also arise. In addition, if we obtain marketing approval for any of our product candidates, we expect to incur significant commercialization expenses related to drug sales, marketing, manufacturing and distribution. Because the design and outcome of our current and anticipated clinical trials are highly uncertain, we cannot reasonably estimate the actual amounts necessary to successfully complete the development and commercialization of any product candidate we develop. We also expect to continue to incur the costs associated with operating as a public company. Accordingly, we will need to obtain substantial additional funding in order to maintain our continuing operations in the future.
As of MarchJune 31,30, 2026, we had $198.6$182.7 million in cash, cash equivalents, and marketable securities. Based on our current business plans, we believe that our existing cash, cash equivalents, and marketable securities will be sufficient to fund our development activities and other operations into 2029. Our estimate as to how long we expect our existing cash, cash equivalents, and marketable securities to be able to continue to fund our operating expenses and capital expenditures requirements 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.
•the initiation, progress, timeline, cost and results of our clinical trials for our product candidates, including our plannedongoing registrational trial of atebimetinib in combination with mGnP in first-line pancreatic cancer;
We are not permitted to commercialize, market, promote or sell any product candidate in the United States without obtaining marketing approval from the FDA. Foreign regulatory authorities, such as the EMA, impose similar requirements. The time required to obtain approval by the FDAFDA, EMA and other comparable foreign regulatory authorities is unpredictable, typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the type, complexity and novelty of the product candidates involved. In addition, approval policies, regulations or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions, which may cause delays in the approval or the decision not to approve an application. Regulatory authorities 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. Even if we eventually complete clinical testing and receive approval of any regulatory filing for our product candidates, the FDA, EMA and other comparable foreign regulatory authorities may approve our product candidates for a more limited indication or a narrower patient population than we originally requested. We have not submitted for, or obtained, regulatory approval for any product candidate, and it is possible that none of our existing product candidates or any product candidates we may seek to develop in the future will ever obtain regulatory approval.
We have limited experience in designing clinical trials and may be unable to design and execute a clinical trial to support marketing approval, including, for example, our planned registrational trial of atebimetinib in combination with mGnP in first-line pancreatic cancer. We cannot be certain that our ongoing or planned clinical trials or any future clinical trials will be successful. For example, in April 2025 we paused further internal advancement of envometinib (IMM-6-415) and the related Phase 1/2a clinical trial. Further, it is possible that the FDA may refuse to accept, or be delayed in accepting, any or all of our planned NDAs for substantive review or may conclude after review of our data that our application is insufficient to obtain regulatory approval for any product candidates. If the FDA does not approve any of our planned NDAs, it may require that we conduct additional costly clinical trials, preclinical studies or manufacturing validation studies before it will reconsider our applications. Depending on the extent of these or any other FDA-required studies, approval of any NDA or other application that we submit may be significantly delayed, possibly for several years, or may require us to expend more resources than we have available. Any failure or delay in obtaining regulatory approvals would prevent us from commercializing our product candidates, generating revenues and achieving and sustaining profitability. It is also possible that additional studies, if performed and completed, may not be considered sufficient by the FDA to approve any NDA or other application that we submit. If any of these outcomes occur, we may be forced to abandon the development of our product candidates, which would materially adversely affect our business and could potentially cause us to cease operations. We face similar risks for applications in foreign jurisdictions with comparable regulatory agencies, including without limitation the EMA.
Further, conducting clinical trials (such as MAPKeeper 301) in foreign countries presents additional risks that may delay completion of our clinical trials. These risks include the failure of enrolled patients in foreign countries to adhere to clinical protocol as a result of differences in healthcare services or cultural customs, managing additional administrative burdens associated with foreign regulatory schemes, including with respect to healthcare, cybersecurity and data privacy matters, as well as political and economic risks or military conflicts relevant to such foreign countries.
Before obtaining regulatory approvals for the commercial sale of any of our product candidates, we will be required to demonstrate with substantial evidence through well-controlled clinical trials that our product candidates are safe and effective for their intended uses. Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical trial process. Success in preclinical studies and early-stage clinical trials does not mean that future or later-stage clinical trials, such as our planned registrational trial of atebimetinib in combination with mGnP in first-line pancreatic cancer, will be successful. We do not know whether any of our product candidates will perform in current or future clinical trials as they have performed in preclinical studies or prior clinical trials. Product candidates in later-stage clinical trials may fail to demonstrate sufficient safety and efficacy to the satisfaction of the FDA, EMA or other comparable foreign regulatory authorities despite having progressed through preclinical studies and early-stage clinical trials.
From time to time, we may also disclose interim data from our preclinical studies and clinical trials. For example, we disclosed updated interim safety and efficacy data from the Phase 2a portion of our ongoing Phase 1/2a clinical trial of atebimetinib in JanuaryJune 2026. Interim data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available or as patients from our clinical trials continue other treatments for their disease. Adverse differences between top-line, preliminary and/or interim data and final data could significantly harm our business prospects. Further, disclosure of interim data by us or by our competitors could result in volatility in the trading price of our Class A common stock.
We are early in our development efforts and we have not yet completed oura Phase 1/2a3 clinical trial for our lead product candidate atebimetinib. Further, we have only disclosed interim Phase 2a data for atebimetinib, and in April 2025 we paused further internal advancement of envometinib and the related Phase 1/2a clinical trial. Our other product candidates are in earlier stages of drug development. We have invested substantially all of our efforts and financial resources in the identification of targets, preclinical and clinical development of small molecules targeting the MAPK and other pathways in cancer therapy.
•the successful initiation, patient enrollment and completion on a timely basis of our ongoing and any future clinical trials (including our plannedongoing registrational trial of atebimetinib in combination with mGnP in pancreatic cancer), despite any delays including those arising out of ongoing or future pandemics, or other widespread adverse health events;
Our future results of operations are dependent on our ability to successfully discover, develop, obtain regulatory approval for and commercialize product candidates beyond those we currently have in preclinical studies and early stage clinical trial development. A product candidate can unexpectedly fail at any stage of preclinical and clinical development. The historical failure rate for product candidates is high due to risks relating to safety, efficacy, clinical execution, changing standards of medical care and other unpredictable variables. The results from preclinical studies or earlier clinical trials of a product candidate may not be predictive of the results that will be obtained in later stage clinical trials of the product candidate.
We intend to conduct clinical trial operations at U.S. and international clinical trials in the future.sites. The acceptance of study data from clinical trials conducted outside the U.S. or another jurisdiction by the FDA or comparable foreign regulatory authority may be subject to certain conditions or may not be accepted at all. In cases where data from foreign clinical trials are intended to serve as the sole basis for marketing approval in the U.S., the FDA will generally not approve the application on the basis of foreign data alone unless (i) the data are applicable to the U.S. population and U.S. medical practice; (ii) the trials were performed by clinical investigators of recognized competence and pursuant to GCP regulations; and (iii) the data may be considered valid without the need for an on-site inspection by the FDA, or if the FDA considers such inspection to be necessary, the FDA is able to validate the data through an on-site inspection or other appropriate means. In addition, even where the foreign study data are not intended to serve as the sole basis for approval, the FDA will not accept the data as support for an application for marketing approval unless the study is well-designed and well-conducted in accordance with GCP requirements and the FDA is able to validate the data from the study through an onsite inspection if deemed necessary. Many foreign regulatory authorities have similar approval requirements. In addition, such foreign trials would beare subject to the applicable local laws of the foreign jurisdictions where the trials are conducted. There can be no assurance that the FDA or any comparable foreign regulatory authority will accept data from trials conducted outside of the U.S. or the applicable jurisdiction. If the FDA or any other comparable foreign regulatory authority does not accept such data, it could result in the need for additional trials, which would be costly and time-consuming and delay aspects of our business plan, and which may result in our current or future product candidates not receiving approval for commercialization in the applicable jurisdiction.
As of MarchJune 31,30, 2026, we had 5557 full-time employees, including 3942 employees engaged in research and development. In order to successfully implement our development and commercialization plans and strategies, including operating as a public company, we expect to need additional managerial, operational, sales, marketing, financial and other personnel. Future growth would impose significant added responsibilities on members of management, including without limitation:
WeOur currently have limitedcurrent international operations,operations relate primarily to clinical trial activities, but our business plans incorporate potential international expansion, for example including the planned addition of international clinical trial sites, potential engagement with a collaborator based internationally, or ifupon any of our product candidates receivesreceiving regulatory approval.approval (which may never occur). Doing business internationally involves a number of risks, including but not limited to:
Management's Discussion & Analysis (MD&A)
New heading “Components of Our Results of Operations”
New heading “Comparison of the Six Months Ended June 30, 2026 and 2025”
New heading “Research and Development”
New heading “General and Administrative”
New heading “Amortization of Intangible Asset”
Largest changes
“In June 2026, we announced further positive interim response and safety data from the Phase 2 mGnP Arm. We announced that, as of a cutoff date of April 24, 2026 (the “Cutoff Date”), 17.3 month median overall survival (“mOS”) was observed in the intent-to-treat population of 55 patients dosed at the 320 mg once-daily dose level of atebimetinib in combination with mGnP (the “320 mg ITT Population”), with median follow-up time of 11.6 months. The standard of care (described below) reported a 8.5 month mOS. …”see in full comparison
Full comparison: every changed paragraph (49)
Our lead product candidate, atebimetinib (IMM-1-104), is an oral, once-daily Deep Cyclic Inhibitor of MEK, designed to improve durability and tolerability across many cancer indications, including MAPK pathway-driven tumors such as pancreatic cancer. We are currently recruiting patients forconducting a Phase 3 clinical trial of atebimetinib, which we call the MAPKeeper 301 trial, to evaluate atebimetinib in combination with mGnP in first-line pancreatic cancer patients. We expect to dosedosed the first patient in the MAPKeeper 301 trial in mid-2026.June 2026.
MAPKeeper 301 is designed as a global Phase 3 registrational trial that willto evaluate atebimetinib (320 mg once-daily) in combination with mGnP, compared to standard of care GnP alone, in first-line metastatic PDAC. The primary endpoint of MAPKeeper 301 is overall survival, and secondary endpoints include progression-free survival, overall response rate, disease control rate, and quality of life measurements. We plan to enroll a total of approximately 510 patients in MAPKeeper 301, divided equally across the two arms.
In January 2026, we announced positive interim response and safety data from our ongoing Phase 2a clinical trial arm evaluating atebimetinib in combination with mGnP in first-line pancreatic cancer patients,patients (the "Phase 2 mGnP Arm"), which is part of our ongoing Phase 1/2a clinical trial of atebimetinib in patients with advanced solid tumors.
In June 2026, we announced further positive interim response and safety data from the Phase 2 mGnP Arm. We announced that, as of a cutoff date of April 24, 2026 (the “Cutoff Date”), 17.3 month median overall survival (“mOS”) was observed in the intent-to-treat population of 55 patients dosed at the 320 mg once-daily dose level of atebimetinib in combination with mGnP (the “320 mg ITT Population”), with median follow-up time of 11.6 months. The standard of care (described below) reported a 8.5 month mOS. As of the Cutoff Date, the median progression free survival ("mPFS") of the 320 mg ITT Population was 8.3 months. As of the Cutoff Date, in response evaluable patients from the 320 mg ITT Population, a 36% (18/50 patients) overall response rate ("ORR") and 82% (41/50 patients) disease control rate ("DCR") was observed. Additionally, as of the Cutoff Date, among the subset of patients from the 320 mg ITT Population for which sufficient weight stability data was available, 84% of such patients either gained weight or else were within 5% of original recorded baseline weight. The reported data included patients from same patient cohort (N=34) as we previously reported in January 2026, as well as an additional 21 patients, together comprising the full 320 mg ITT Population. The estimates of (and other references to) standard of care set forth above with respect to mOS data were reported out directly from the publicly available third-party MPACT pivotal trial data for gemcitabine/nab-paclitaxel. Our Phase 1/2a clinical trial of atebimetinib does not include a head-to-head comparison against any other agents, and caution should be exercised when comparing data across trials.
We also announced that, as of the Cutoff Date, atebimetinib in combination with mGnP continued to be generally well tolerated. As of the Cutoff Date, Grade ≥ 3 treatment-emergent adverse events (“TEAEs”) observed in 10% or greater of patients in the 320 mg ITT Population consisted of Anemia (nine patients or 16%) and Neutropenia (ten patients or 18%). Grade ≥ 3 TEAEs observed in less than 10% of patients in the 320 mg ITT Population included Rash (5%), Fatigue (2%), Vomiting (2%), and Oedema Peripheral (2%). No Grade 5 TEAEs were observed in this patient population and no new safety signals were identified.
We expect the following anticipated milestones:
•in the second half of 2026, dosing the first patient in a clinical trial of atebimetinib in combination with Libtayo® in non-small cell lung cancer patients, with a preliminary data readout expected in late-2027;
•in the fourth quarter of 2026, additional pre-clinical data of atebimetinib in combination with anti-PD-1 in non-small cell lung cancer;
•in mid-2027, beginning IND-enabling studies for our next DCI product candidate program; and
•in mid-2028, providing a topline data readout from the MAPKeeper 301 trial.
We expect the following additional near-term milestones related to atebimetinib: announcing further updated survival and safety data from an expanded cohort of approximately 55 first-line pancreatic cancer patients treated with atebimetinib in combination with mGnP in our ongoing Phase 1/2a clinical trial, in the second quarter of 2026; and dosing the first patient in a planned clinical trial of atebimetinib in combination with Libtayo® in non-small cell lung cancer patients, in the second half of 2026.
We did not sell any shares of common stock under the 2022 ATM Program during the three and six months ended MarchJune 31,30, 2026. We sold 4,836,804 shares of common stock under the 2022 ATM Program, at a weighted average price per share of $2.95, for aggregate gross proceeds of $14.2 million ($13.7 million net of offering expenses) during the three and six months ended MarchJune 31,30, 2025. We did not sell any shares of common stock under the 2025 ATM Program during the three and six months ended MarchJune 31,30, 2026 or MarchJune 31,30, 2025.2025, respectively.
On August 21, 2025, we entered into the August 2025 Purchase Agreement with the purchasers party thereto, pursuant to which we agreed to sell securities to such purchasers in the August 2025 Private Placement. The August 2025 Purchase Agreement provided for the sale and issuance by us to the purchasers of: (i) an aggregate of 5,251,349 shares of our common stock at a purchase price of $3.95 per share, (ii) for certain purchasers, in lieu of common stock, an aggregate of 1,077,764 Pre-Funded Warrants to purchase up to the same number of shares of our common stock, and (iii) an aggregate of 2,848,096 Purchase Warrants to purchase up to the same number of shares of our common stock. The Pre-Funded Warrants were issued for a purchase price equating to $3.949 per Pre-Funded Warrant (which was the per share purchase price for the common stock issued in the August 2025 Private Placement, less the $0.001 per share unfunded exercise price for each Pre-Funded Warrant); following the October 2025 Cashless Exercise, no Pre-Funded Warrants remained issued and outstanding. The Purchase Warrants were issued with an exercise price of $5.50 per share; as of MarchJune 31,30, 2026, no Purchase Warrants had been exercised. As of MarchJune 31,30, 2026, we had received aggregate net proceeds of $23.4 million from the August 2025 Private Placement, after deducting placement expenses of $1.6 million. The August 2025 Private Placement closed on August 26, 2025.
Since our inception, we have had significant annual operating losses. Our net loss was approximately $13.5$30.7 million for the threesix months ended MarchJune 31,30, 2026 and approximately $56.0 million for the year ended December 31, 2025. As of MarchJune 31,30, 2026, we had an accumulated deficit of approximately $293.8$311.1 million and approximately $198.6$182.7 million in cash, cash equivalents and marketable securities.
Based on our current business plans, we believe that our existing cash, cash equivalents and marketable securities as of MarchJune 31,30, 2026 will enable us to fund our development activities and other operations into 2029. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. To finance our operations beyond that point we will need to raise additional capital, which cannot be assured. We may be unable to raise additional funds or enter into such other arrangements when needed or on favorable terms, if at all. Any failure to raise capital as and when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies, including our research and development activities. If we are unable to raise capital, we will need to delay, reduce or terminate some or all planned activities to reduce costs.
As of MayAugust 15,5, 2026, the issuance date of the interim condensed consolidated financial statements for the three-monthsthree and six-months ended MarchJune 31,30, 2026 included elsewhere in this Quarterly Report on Form 10-Q, based on our recurring losses from operations incurred since inception, expectation of continuing operating losses for the foreseeable future and the need to raise additional capital to finance future operations, we believe that our existing cash, cash equivalents and marketable securities will enable us to fund our development activities and other operations into 2029. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. To finance our operations beyond that point we will need to raise additional capital, which cannot be assured.
Components of Our Results of Operations
Comparison of the Three Months Ended MarchJune 31,30, 2026 and 2025
Research and development expenses decreasedincreased by approximately $0.8$3.5 million, or 7.2%,33.9%, to approximately $10.6$14.0 million for the three months ended MarchJune 31,30, 2026, as compared to approximately $11.5$10.5 million for the three months ended MarchJune 31,30, 2025. The decreaseincrease of approximately $0.8$3.5 million was primarily due to aan decreaseincrease in direct costs of $1.0$2.8 million, primarily driven by a $1.6$2.1 million related to the initiation of the MAPKeeper 301 trial, in addition to increased preclinical spend of approximately $1.0 million, driven by development pipeline activities. The increase in direct research and development expenses was offset by a decrease of approximately $0.3 million in expenses related to the envometinib programprogram, due to the Company's prioritization of the atebimetinib program, in addition to a $0.2 million decrease in expenses related to atebimetinib due to the timing of expenses related to the initiation of the MAPKeeper 301 trial.program. The decreaseoverall toincrease in research and development expenses was offset by increased preclinical spend of approximately $0.8 million,also driven by development pipeline activities, and by an increase in indirect expenses of approximately $0.2$0.7 million, primarily driven by increased employee-related costs of $0.3$0.7 million, further offset byincreased stock-based compensation costs of $0.1 million, offset by a decrease in addition to depreciation/amortization and facilities and other expenses of $5$1 thousand.
General and administrative expenses increased by approximately $0.7 million, or 16.9%,16.3%, to approximately $4.7$5.0 million for the three months ended MarchJune 31,30, 2026, as compared to approximately $4.0$4.3 million for the three months ended MarchJune 31,30, 2025. The increase of approximately $0.7 million was primarily driven by a $0.4$0.5 million increase in employee-related costs, a $0.2 million increase in professional fees for accounting, auditing and legal services, and a $0.1 million increase in other expenses, primarily consisting of increased software costs supporting the general and administrative functions, and a $0.1 million increase in professional fees, stock-based compensation, and facilities and other allocated expenses, in the aggregate.
Amortization of intangible asset was $7,317 for the three months ended MarchJune 31,30, 2026 and 2025. This amortization is related to the technology acquired from the BioArkive acquisition completed in December 2021.
Interest income from the interest earned on our cash, cash equivalents and marketable securities balances increased by approximately $0.9$0.8 million for the three months ended MarchJune 31,30, 2026 as compared to the three months ended MarchJune 31,30, 2025, driven primarily by an increased total cash balance resulting from various financing events in August and September 2025.
Other income for the three months ended MarchJune 31,30, 2026 was $0.5$0.6 million, compared to no other income for the three months ended MarchJune 31,30, 2025. This was primarily driven by the accretion of marketable securities during the three months ended MarchJune 31,30, 2026. There were no marketable securities as of MarchJune 31,30, 2025.
Comparison of the Six Months Ended June 30, 2026 and 2025
The following table summarizes our results of operations for the periods indicated:
Research and Development
The following table summarizes the components of research and development expenses for the periods indicated:
Research and development expenses increased by approximately $2.7 million, or 12.4%, to approximately $24.6 million for the six months ended June 30, 2026, as compared to approximately $21.9 million for the six months ended June 30, 2025. The increase of approximately $2.7 million was primarily due to an increase in direct research and development expenses of $1.8 million, driven by a $1.9 million increase in expenses related to the initiation of the MAPKeeper 301 trial, in addition to increased preclinical spend of approximately $1.8 million. This was offset by a decrease of approximately $1.9 million in expenses related to the envometinib program, due to the Company's prioritization of the atebimetinib program. The overall increase to research and development expenses was also driven by an increase of approximately $0.9 million related to indirect research and development expenses. Indirect expenses were driven by an approximate $1.0 million increase associated with employee-related costs, offset by a minor decrease in stock-based compensation expense, depreciation/amortization, and facilities and other expenses, in the aggregate.
General and Administrative
The following table summarizes the components of general and administrative expenses for the periods indicated:
General and administrative expenses increased by approximately $1.4 million, or 16.6%, to approximately $9.7 million for the six months ended June 30, 2026, as compared to approximately $8.3 million for the six months ended June 30, 2025. The increase of approximately $1.4 million was due to a $0.9 million increase in employee-related costs, an increase in professional fees incurred for accounting, auditing, legal and tax services of approximately $0.3 million, increased other expenses of approximately $0.2 million, primarily consisting of software costs supporting the general and administrative functions, and increased stock-based compensation costs of approximately $0.1 million.
Amortization of Intangible Asset
Amortization of intangible asset was $14,633 for the six months ended June 30, 2026, and 2025. This amortization is related to the technology acquired for the BioArkive acquisition completed in December 2021.
Interest income increased by approximately $1.7 million for the six months ended June 30, 2026, compared to the six months ended June 30, 2025, driven primarily by an increased total cash balance resulting from various financing events in August and September 2025.
Other income for the six months ended June 30, 2026 was approximately $1.2 million, compared to no other income for the six months ended June 30, 2025. This was primarily driven by the accretion of marketable securities during the six months ended June 30, 2026. There were no marketable securities as of June 30, 2025.
As of MarchJune 31,30, 2026, we had an accumulated deficit of $293.8$311.1 million and $198.6$182.7 million in cash, cash equivalents and marketable securities. Cash, cash equivalents and marketable securities are comprised primarily of deposits at major financial banking institutions and highly liquid investments with an original maturity of three months or less at the date of purchase. Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures, and to a lesser extent, general and administrative expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, reflected in the change in our outstanding accounts payable and accrued expenses.
On August 10, 2022, we entered into the 2022 Sales Agreement with the Sales Agent to sell shares of our common stock with aggregate gross proceeds of up to $50 million, from time to time, through the 2022 ATM Program. We did not sell any shares of common stock under the 2022 ATM Program during the three and six months ended MarchJune 31,30, 2026. We sold 4,836,804 shares of common stock under the 2022 ATM Program, at a weighted average price per share of $2.95, for aggregate gross proceeds of $14.2 million ($13.7 million net of offering expenses) during the three and six months ended MarchJune 31,30, 2025. In August 2025, the 2022 Shelf Registration Statement and the 2022 ATM Program expired, and the 2022 Sales Agreement was terminated.
On August 13, 2025, we entered into the 2025 Sales Agreement with the Sales Agent, to sell shares of our common stock with aggregate gross proceeds of up to $100 million, from time to time, through the 2025 ATM Program. In connection with the September 2025 Offering, we: (i) reduced the maximum aggregate offering price for sales of shares of common stock pursuant to at-the-market transactions under the 2025 ATM Program by the Reduced Amount, resulting in a new maximum aggregate offering price of up to $98,749,993 under the 2025 ATM Program, and (ii) suspended the 2025 ATM Program and terminated the continuous offering under the 2025 ATM Program, in each case, as to the Reduced Amount. We did not sell any shares of common stock under the 2025 ATM Program during the three and six months ended MarchJune 31,30, 2026 or MarchJune 31,30, 2025, respectively.
On August 21, 2025, we entered into the August 2025 Purchase Agreement with the purchasers party thereto, pursuant to which we agreed to sell securities to such purchasers in the August 2025 Private Placement. The August 2025 Purchase Agreement provided for the sale and issuance by us to the purchasers of: (i) an aggregate of 5,251,349 shares of our common stock at a purchase price of $3.95 per share, (ii) for certain purchasers, in lieu of common stock, an aggregate of 1,077,764 Pre-Funded Warrants to purchase up to the same number of shares of our common stock, and (iii) an aggregate of 2,848,096 Purchase Warrants to purchase up to the same number of shares of our common stock. The Pre-Funded Warrants were issued for a purchase price equating to $3.949 per Pre-Funded Warrant (which was the per share purchase price for the common stock issued in the August 2025 Private Placement, less the $0.001 per share unfunded exercise price for each Pre-Funded Warrant); following the October 2025 Cashless Exercise, no Pre-Funded Warrants remained issued and outstanding. The Purchase Warrants were issued with an exercise price of $5.50 per share; as of MarchJune 31,30, 2026, no Purchase Warrants had been exercised. As of MarchJune 31,30, 2026, we had received aggregate net proceeds of $23.4 million from the August 2025 Private Placement, after deducting placement expenses of $1.6 million. The August 2025 Private Placement closed on August 26, 2025.
As of MarchJune 31,30, 2026, we had contractual obligations related to various leases of $0.6$0.4 million for 2026, $0.8 million for 2027, $0.8 million for 2028, $0.8 million for 2029, $0.9 million for 2030 and $1.2 million for the periods thereafter.
Based on our current business plans, we believe that our existing cash, cash equivalents and marketable securities as of MarchJune 31,30, 2026 will enable us to fund our development activities and other operations into 2029. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. To finance our operations beyond that point we will need to raise additional capital, which cannot be assured. We may be unable to raise additional funds or enter into such other arrangements when needed or on favorable terms, if at all. Any failure to raise capital as and when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies, including our research and development activities. If we are unable to raise capital, we will need to delay, reduce or terminate some or all planned activities to reduce costs.
During the threesix months ended MarchJune 31,30, 2026, operating activities used approximately $18.4$34.9 million of cash, primarily resulting from our net loss of approximately $13.5$30.7 million andmillion, changes in assets and liabilities of $6.4$6.9 million, and accretion of discount of marketable securities of $0.9 million. This was partially offset by stock-based compensation expense of approximately $1.6$3.3 million, depreciation of approximately $0.1$0.2 million and the reduction in carrying amount of right-of-use assets of approximately $0.1$0.2 million.
During the threesix months ended MarchJune 31,30, 2025, operating activities used approximately $14.1$23.5 million of cash, primarily resulting from our net loss of approximately $15.0$29.5 million and changes in assets and liabilities of $1.0$2.4 million, partially offset by stock-based compensation expense of approximately $1.7$3.2 million, depreciation of approximately $0.2 million and the reduction in carrying amount of right-of-use assets of approximately $0.1$0.2 million.
During the threesix months ended MarchJune 31,30, 2026, investing activities used approximately $63.1$52.6 million of cash, primarily resulting from purchases of marketable securities of $72.0$84.0 million and purchases of property and equipment of approximately $80$0.1 thousand,million, offset by maturities of marketable securities of $9.0$31.5 million.
During the threesix months ended MarchJune 31,30, 2025, investing activities used approximately $9$11 thousand, primarily resulting from purchases of property and equipment of approximately $9$11 thousand.
During the threesix months ended MarchJune 31,30, 2026, net cash provided by financing activities was approximately $0.2 million, primarily driven by proceeds of approximately $0.2 million from the sale of common stock pursuant to our employee stock purchase plan and $10$35 thousand from the exercise of stock options.
During the threesix months ended MarchJune 31,30, 2025, net cash provided by financing activities was approximately $13.8$13.7 million, primarily driven by proceeds of approximately $13.7 million from the sale of common stock under ourthe 2022 ATM program,Program, net of offeringissuance expenses,costs, in addition to $0.1$0.2 million from the sale of common stock pursuant to ourCompany's employee stock purchase plan.plan and exercise of stock options. This was partially offset by payments of offering costs of $0.1 million
•the costs and results of our ongoing clinical trialtrials for atebimetinib, our planned registrational trial of atebimetinib in combination with mGnP in first-line pancreatic cancer, and potential future clinical trials for atebimetinib and our other product candidates;
Based on our currently forecasted operating plan, we believe that our existing cash, cash equivalents and marketable securities as of MarchJune 31,30, 2026 will enable us to fund our operating expenses and capital expenditure requirements into 2029. Based on our recurring losses from operations incurred since inception, our expectation of continuing operating losses for the foreseeable future and the need to raise additional capital to finance future operations, as of MayAugust 15,5, 2026, the issuance date of the interim condensed consolidated financial statements for the three-monthsthree and six-months ended MarchJune 31,30, 2026 included elsewhere in this Quarterly Report on Form 10-Q, management considered whether or not there are conditions or events, in the aggregate, that raise substantial doubt about the entity’s ability to continue as a going concern, and concluded that there are none as it estimates that its cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements for at least 12 months from the issuance date of these unaudited condensed consolidated financial statements.
IMRX insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 2 Form 4 filings (2 insiders, 2 trade dates, 8,435 shares, about $36.0K) and open-market sales in 0 filings. Net open-market shares: 8,435 (purchases minus sales); net value about $36.0K.Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
| Trade date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-06-23 | Zeskind Benjamin J. |
Open-market purchase | 2,400 | $4.56 | $10.9K |
| 2026-06-15 | Hall Brett Matthew |
Open-market purchase | 6,035 | $4.15 | $25.0K |
Well-known investors holding IMRX (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| Citadel Advisors (Ken Griffin) | 2026-06-30 | 386,411 | $1.9M | 0.0% | Reduced 14% |
| Millennium Management (Israel Englander) | 2026-06-30 | 330,402 | $1.6M | 0.0% | Reduced 70% |
| Two Sigma Investments | 2026-06-30 | 288,420 | $1.4M | 0.0% | Added 18% |
| D. E. Shaw & Co. | 2026-06-30 | 203,663 | $1.0M | 0.0% | New position |
| Renaissance Technologies | 2026-06-30 | 72,875 | $384.1K | — | Sold out |