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

We are a late clinical-stage biotechnology company and have not yet generated revenues from product sales. To date, substantially all of our revenues have been derived from past grants and contracts with governmental agencies. We have incurred net losses in most periods since our inception, including a net loss of $95.1$88.1 million and $88.4$95.1 million for the years ended December 31, 20242025 and 2023,2024, respectively. As of December 31, 2024,2025, we have an accumulated deficit of $561.4$649.5 million. To date, we have not received regulatory approvals for any products or generated any revenues from the sale of products, and we do not expect to generate any product revenues in the foreseeable future. We do not know whether or when we will generate product revenues or become profitable.

We have devoted most of our financial resources to research and development, including preclinical and clinical development of our product candidates. We have not completed pivotal clinical trials for any product candidate. Our leadinglead product candidatescandidate, remainpemvidutide, inhas early-stagecompleted clinicalPhase 2 development, and we are planning for Phase 3 clinical development but it may be several years, if ever, before we have a product candidate ready for commercialization. Even if we obtain regulatory approval to market a product candidate, our future revenues will depend upon the size of any markets in which our product candidates have received approval, our ability to achieve sufficient market acceptance, reimbursement from third-party payers and other factors.

Our product candidates are still in an early stage of development, there is a high risk of failure, and we may never succeed in developing marketable products or generating product revenue.

Our preclinical and clinical results are not necessarily predictive of the final results of our ongoing or future clinical trials. Success in preclinical and early clinical studies may not be predictive of similar results in humans during later clinical trials, and successful results from early or small clinical trials of a product candidate may not be replicated in later and larger clinical trials.

Clinical trials are expensive, time consuming and uncertain as to outcome, and we cannot guarantee that any of these activities will be successful. If the results of our ongoing or future clinical trials are inconclusive with respect to the efficacy of our product candidates, if we do not meet our clinical endpoints with statistical significance or if there are safety concerns or adverse events associated with our product candidates, we may be prevented or delayed in obtaining marketing approval for our product candidates, or we may determine to suspend development of or abandon specific product candidates. For example, in 2015, we suspended the development of a Densigen platform-based product candidate, Flunisyn, which was being developed as a T-cell vaccine for the treatment of influenza, in favor of NasoVAX. Clinical trials with this product candidate showed that it was generally well-tolerated and able to induce robust T-cell responses against the viral sequences represented, but a comparison of the entire study population in later-stage clinical trials showed no statistical differences between the vaccinated and placebo groups for several measures of protection.

In addition, we can offer no assurances that we have correctly estimated the resources or personnel necessary to seek partners, co-developers or acquirers for our programs. If a larger workforce or one with a different skillset is ultimately required to maintain or build these operations, we may be unable to maximize our existing programs.

From time to time, we may publish interim data, including interim top-line results or preliminary resultsdata from our preclinical studies and clinical trials. Any interim data and other results from our preclinical studies and clinical trials may materially change as more patient data become available. We also may make assumptions, estimations, calculations and conclusions as part of our analyses of preliminary or topline data, and we may not have received or had the opportunity to fully and carefully evaluate all data. Preliminary or top-line results also remain subject to audit, validation and verification procedures that may result in the final data being materially different from the interim and preliminary data we previously published. As a result, interim and preliminary data may not be predictive of final results and should be viewed with caution until the final data are available. We may also arrive at different conclusions, or considerations may qualify such results, once we have received and fully evaluated additional data. DifferencesMaterial differences between preliminary or interim data and final data could adversely affect our business.

Additionally, our CMOs may experience manufacturing difficulties due to regulatory issues, resource constraints, including manufacturing capacity, material constraints, or as a result of labor disputes or unstable political environments. If our CMOs were to encounter any of these difficulties, our ability to provide our product candidate to patients in clinical trials, or to provide product for treatment of patients once approved, would be jeopardized.

We, the FDA, other regulatory authorities outside the United States, or an IRB may suspend a clinical trial at any time for various reasons, including if it appears that the clinical trial is exposing participants to unacceptable health risks or if the FDA or one or more other regulatory authorities outside the United States find deficiencies in our IND or similar application outside the United States or the conduct of the trial. Delays, including delays caused by the above factors, can be costly and could negatively affect our ability to complete a clinical trial. For example, we have had delays in previous clinical trials, including those conducted for NasoVAX, as a result of clinical holds imposed by the FDA or other regulatory authorities and requests for additional or new information on vaccine product testing in connection with an IND submitted to the FDA. We have previously experienced multiple failures during the manufacturing of clinical materials for use in a NasoVAX Phase 2 clinical trial.

Identifying and qualifying subjects to participate in clinical trials of our product candidates is critical to our success. The timing of our clinical trials depends on the speed at which we can recruit eligible subjects to participate in testing our product candidates. If subjects are unwilling to participate in our trials due to restrictions on travel or healthcare institution policies, negative publicity from adverse events in the biotechnology industries, public perception of vaccine safety issuesindustries or for other reasons, including competitive clinical trials for similar patient populations, the timeline for recruiting subjects, conducting studies and obtaining regulatory approval of potential products may be delayed. These delays could result in increased costs, delays in advancing our product development, delays in testing the effectiveness of our technology or termination of the clinical trials altogether.

We may not be able to identify, recruit and enroll a sufficient number of eligible subjects, or those with required or desired characteristics to achieve diversity in a trial, to complete our clinical trials in a timely manner. Subject enrollment and retention is affected by several factors, including:

We may not be able to initiate or continue clinical trials if we cannot enroll a sufficient number of eligible subjects to participate in the clinical trials required by regulatory agencies. Even if we enroll a sufficient number of eligible subjects to initiate our clinical trials, we may be unable to maintain participation of these subjects throughout the course of the clinical trial as required by the clinical trial protocol, in which event we may be unable to use the research results from those subjects. If we have difficulty enrolling and maintaining the enrollment of a sufficient number of subjects to conduct our clinical trials as planned, we may need to delay, limit or terminate ongoing or planned clinical trials, any of which would have an adverse effect on our business.

Large and established companies such as Eli Lilly, Roche,,Roche, Novo Nordisk, Pfizer, AstraZeneca, Amgen, Boehringer Ingelheim and Merck, among others, compete in the same marketgeneral therapeutic areas as our product candidates.programs. These companies compete with us with their greater experience and resources to support their research and development efforts, conduct testing and clinical trials, obtain regulatory approvals to market products, manufacture such products on a broad scale and market approved products. These companies also compete with us by having significantly greater research and marketing capabilities than we do and may also have products that have been approved or are in late stages of development and have collaborative arrangements in our target markets with leading companies and research institutions. Established pharmaceutical companies may also invest heavily to accelerate discovery and development of novel compounds or to in-license novel compounds that could make the products that we develop obsolete. We also face competition from smaller companies who, like us, rely on investors to fund research and development and compete for co-development and licensing opportunities from large and established pharmaceutical companies.

We face competition for pemvidutide, our dual glucagon/GLP-1/glucagon dual agonist for the treatment of obesity and MASH. For obesity, we face competition from companies such as Novo Nordisk, whose GLP-1 agonist, brand named Wegovy, or compound name semaglutide, was approved for weight loss in June 2021 and Eli Lilly, whose GLP-1/glucose-dependent insulinotropic polypeptide receptor (“GIP”) dual agonist, brand named Zepbound, or compound name tirzepatide, was approved for obesity in November 2023. Other companies with potentially competitive product candidates include Roche and Viking Therapeutics with GLP-1/GIP dual agonists; Boehringer Ingelheim, AstraZeneca, D&D Pharmatech, and Innovent Biologics/Eli Lilly, with GLP-1/glucagon receptor dual agonists; Hanmi Pharmaceutical and Eli Lilly with GLP-1/glucagon/GIP triple agonists; Amgen with its GLP-1 agonist/GIP antagonist antibody; and Novo Nordisk with Amylin and Amylin-GLP-1 combination candidates. Other companies have been developing oral candidates for the treatment of obesity with GLP-1 monoagonist or GLP-1/GIP dual receptor agonists including Pfizer, Lilly, Structure Therapeutics, AstraZeneca, Viking Therapeutics, and Roche. In addition, Novo Nordisk has an FDA-approved oral GLP-1 therapy, Rybelsus or compound name semaglutide. We face competition in MASH from companies such as Madrigal Pharmaceuticals, Terns, Aligos and Viking Therapeutics, which are developing orally administered, thyroid hormone receptor (“THR”) β-selective agonists; Akero Therapeutics, 89Bio, Novo NordiskNordisk, Roche, and Boston Pharmaceuticals,GSK, which are developing fibroblast growth factor 21 (“FGF-21”) analogs; Novo Nordisk, which is developing a GLP-1 agonist; Merck/Hanmi Pharmaceutical and Boehringer Ingelheim, which are developing GLP-1/glucagon dual agonists,agonists; Eli Lilly, which is developing a GIP/GLP-1 dual agonist and a GIP/GLP-1/glucagon triple agonist; Roche which is developing a GLP-1/GIP dual agonist,agonist; AstraZeneca developing a GLP-1/glucagon and amylin combination; Inventiva, which is developing a pan-peroxisome proliferator-activated receptor (“PPAR”) agonist; Sagimet which is developing a fatty acid synthetase inhibitor, Apollo Therapeutics Group Limited/HEC Pharma which is developing a GLP-1/FGF-21dual agonist; and PfizerPfizer, Roche, Gilead, AstraZeneca, and Eli Lilly, which are developing small molecule GLP-1 agonists. In addition, many other small companies are developing other new technologies directed towards obesity or MASH.

We currently have no products approved for commercial distribution. Our business strategy is to build a pipeline of product candidates using our proprietary platforms, including our leading product candidate, pemvidutide, and to progress the product candidate through clinical development for the treatment of different types of diseases. We may not be able to develop products that are safe and effective for all or any of the indications that we target. Even if we are successful in building a product pipeline, the potential product candidates that we identify may not be suitable for clinical development for a number of reasons, including causing harmful side effects or demonstrating other characteristics that indicate a low likelihood of receiving marketing approvalapproval, or achieving market acceptance. If our methods of identifying potential product candidates fail to produce a pipeline of potentially viable product candidates, then our success as a business will be dependent on the success of fewer potential product candidates,candidate programs, which introduces risks to our business model and potential limitations to any success we may achieve.

We are highly dependent on members of our senior management, including Dr.Jerome Vipin Garg,Durso, our President and Chief Executive Officer, Gregory Weaver, our Chief Financial Officer, Dr. ScottChristophe Harris,Arbert-Engels, our Chief Medical Officer, Dr. M. Scot Roberts, our Chief Scientific OfficerOfficer, andLinda Raymond Jordt,Richardson, our Chief BusinessCommercial Officer and Robin Abrams, our Chief Legal Officer. Although we have entered into employment agreements with each of these members of senior management and key employees, the loss of the services of any of these persons could impede the achievement of our research, development and commercialization objectives.

Recruiting and retaining qualified scientific, clinical, manufacturing, sales and marketing personnel will also be critical to our success. The loss of the services of our executive officers or other key employees could impede the achievement of our research, development, commercialization and business development objectives and seriously harm our ability to successfully implement our business strategy. Furthermore, replacing executive officers and key employees may be difficult and may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to successfully develop, gain regulatory approval of and commercialize products. Competition to hire from this limited pool is intense, and we may be unable to hire, train, retain or motivate these key personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar personnel. We also experience competition for the hiring of scientific and clinical personnel from universities and research institutions. In addition, we rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our research and development and commercialization strategy. Our consultants and advisors may be employed by employers other than the Companyus and may have commitments under consulting or advisory contracts with other entities that may limit their availability to the Company.us. If we are unable to continue to attract and retain high quality personnel, our ability to pursue our growth strategy will be limited.

In addition, recent developments in the national and worldwide supply chain slowdown, including as a result of the conflictgeopolitical conflicts such as in Israel and the Gaza Strip, and the conflict in Ukraine, have resulted in increased cost and reduced supply for supplies and materials. It is impossible to predict how long this supply chain slowdown will last or how much it will impact our business operations, but it is likely that our costs will increase for supplies.

Global inflation rates have increased to levels not seen in several decades, which may result in increases in our operating costs, including our labor costs, constrained credit and liquidity, reduced government spending and volatility in financial markets which may adversely affect the Company’sour business and financial condition. Additionally,Such the transition to a new administration under President Trump could cause additional legal, politicaluncertainty, and economicrelated uncertainty. The Federal Reserve and other international government agencies have raised, and may again raise, interest rates in response to concerns over inflation risk. Increasesincreases in interest rates on credit and debt that would increase the cost of any borrowing that we may make from time to time andtime, could impact our ability to access the capital markets.

We had U.S. federal and state net operating loss carryforwards of approximately $186.6$366.6 million and $184.8$365.0 million, respectively, as of December 31, 2024,2025, of which a portion of the federal and state amount of $7.1 million and $184.8$365.0 million, respectively, has a 20-year carry forward period that will expire at various dates beginning in 2024. Under current law, the remaining federal amount of $179.5$359.5 million has an indefinite life and generally may not be carried back to prior taxable years. For net operating losses arising in taxable years beginning after December 31, 2017, we are permitted a net operating loss deduction that is limited to 80% of our taxable income in such year. The net operating loss carryforwards are subject to a 382-limitation related to ownership changes. Under Section 382 of the Code, a corporation that undergoes an “ownership change” is subject to limitations on its ability to utilize its net operating losses (“NOLs”), to offset U.S. federal and state taxable income. For these purposes, an ownership change generally occurs in the event of a cumulative change in ownership of the Companyus of more than 50% within any three-year period. We have reviewed our stock ownership for any ownership changes as defined under IRC Section 382 from January 1, 2021 through November 3, 2023 and determined that the ownership change was less than 50% during that period. Our existing NOLs are subject to limitations arising from previous ownership changes impacting the timing and amount, and the impact of such changes is reflected in the NOL amounts disclosed above. In addition, future changes in our stock ownership, many of which are outside of our control, could result in an ownership change. Accordingly, we may not be able to utilize a material portion of our NOLs and this could harm our future operating results by effectively increasing our future tax obligations.

We expect to rely on third-party CROs and consultants to assist in filing and supporting the applications necessary to gain marketing approvals. Securing marketing approval requires the submission of extensive preclinical and clinical data and supporting information to regulatory authorities for each therapeutic indication of each of our product candidates to establish the product candidates’ safety and efficacy for such indications. Securing marketing approval also requires the submission of information about the product manufacturing process to, and inspection of manufacturing facilitiesfacilities, and often certain clinical trial sites by, regulatory authorities.

The pathway to regulatory approvals is time consuming and unpredictable, involves substantial costs and consumes management time and attention. It is not possible to predict the timing or success of obtaining regulatory approvals with any degree of certainty, and as a result, it is difficult to forecast our future financial results or prospects. Any unexpected developmentdevelopments in the regulatory approval process, including delays or denials of regulatory approvals or significant modifications to our product candidates required by ourregulatory regulators,authorities, could materially and adversely affect our business, results of operations and financial condition, and could substantially harm our stock price.

To obtain marketing approval, United States laws requirerequire, among other things:

Significant adverse events caused by our product candidates or even competing products in development that utilize a common mechanism of action could cause us, an IRB or ethics committee, and/or regulatory authorities to interrupt, delay or halt one or more clinical trials and could result in clinical trial challenges such as difficulties in patient recruitment, retention, and adherence, the denial of regulatory approval by the FDA or other regulatory authorities and potential product liability claims. Serious adverse events deemed to be caused by our product candidates could have a material adverse effect on the development of our product candidates and our business as a whole. The most common adverse events observed in clinical trials for product candidates developed using the Densigen platform include injection site reactions, headache, malaise and fatigue.

Breakthrough Therapy Designation and Fast trackTrack designationDesignation by the FDA may not lead to a faster development or regulatory review or approval process, and does not assure FDA approval of any product candidates that we may develop.

FDA’s fastBreakthrough trackTherapy programDesignation is intended to expedite the development and review of certainmedicines qualifyingthat productsare intended forto the treatment of serious diseases and conditions. If a product candidate is intended for the treatment oftreat a serious or life threateninglife-threatening condition and preclinicalhave shown preliminary clinical evidence indicating the potential for substantial improvement over available therapies on one or clinicalmore dataclinically demonstratesignificant the product’s potential to address an unmet medical need for this condition, the sponsor may apply for FDA fast track designation.endpoints. In OctoberDecember 2023, we announced that2025, the FDA granted fastBreakthrough trackTherapy designationDesignation to our clinical program investigatingfor pemvidutide forin MASH based on submission of 24-week data from the treatmentIMPACT Phase 2b trial demonstrating statistically significant MASH resolution without worsening of MASH.fibrosis, along with early and substantial improvements in liver fat and non-invasive tests of fibrosis and hepatic inflammation. Even with fastBreakthrough trackTherapy designation,Designation, we may not experience a faster development process, review or approval for pemvidutide compared to conventional FDA procedures, and fastBreakthrough trackTherapy designationDesignation does not ensure that a product candidate will receive marketing approval at all.approval. In addition, the FDA may withdraw fastBreakthrough trackTherapy designationDesignation if it believes that the designation is no longer supported by data from our clinical development program.

We intend to market certain of our product candidates, if approved, in the United Kingdom and other international markets, in addition to the United States. Such marketing will require separate regulatory approvals in each market and compliance with numerous and varying regulatory requirements. The approval procedures vary among countries and may involve requirements for additional testing, and the time required to obtain approval may differ from that required to obtain FDA approval. In addition, in many countries outside the United States, such as certain countries of the European Union, apricing vaccineand orreimbursement therapeuticdecisions must be approved for reimbursement, (including the price that can be charged,charged) beforemay itaffect canthe betiming approvedand forextent saleof commercialization in that country. In these countries, pricing discussions with governmental authorities can take considerable time after the receipt of marketing approval for a product, and additional clinical research may be required to enable comparison of the cost effectiveness of our product candidate to other available alternatives. Approval by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval by one foreign regulatory authority does not ensure approval by regulatory authorities in other foreign countries or by the FDA. However, the failure to obtain approval in one jurisdiction may compromise our ability to obtain approval elsewhere. The foreign regulatory approval process may include all of the risks associated with obtaining FDA approval. We may not obtain foreign regulatory approvals on a timely basis, if at all.

Any regulatory approvals that we receive for our product candidates may be subject to limitations on the approved indicated uses for which the product may be marketed or to conditions of approval. We may also be required to conduct post-marketing testing, including Phase 4 clinical trials, and surveillance to monitor the safety and efficacy of the product potentially over many years. If the FDA or other regulatory authority approves any of our product candidates, the manufacturing processes, quality control, labeling, packaging, distribution, import, export, adverse event reporting, storage, advertising, promotion and recordkeeping for the product will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with cGMP, and compliance with cGMP and GCPGCP, including for any clinical trials that we conduct post-approval. Manufacturers and manufacturers’ facilities are also required to comply with extensive FDA and comparable foreign regulatory authority requirements, including ensuring that quality control and manufacturing procedures conform to cGMP regulations and applicable product tracking and tracing requirements. Any such restrictions regulatory requirements or may result in significant additional expenseexpenses or could limit sales of the approved product. If we, or any of the third parties on which we rely, fail to meet those requirements, the FDA or comparable regulatory authorities outside the United States could initiate enforcement action. Other consequences include the issuance of fines, FDA Form 483s, warning letters, untitled letters or holds on clinical trials, product seizure or detention or refusal to permit the import or export of our product candidates, and permanent injunctions and consent decrees, including the imposition of civil or criminal penalties, among other consequences, that could significantly impair our ability to successfully commercialize a given product.

Any current or future product candidate we may develop and the activities associated with their development and commercialization, including their design, testing, manufacture, safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale, import, export and distribution, are subject to comprehensive regulation by the FDA and other regulatory authorities in the United States and by comparable authorities in other countries. Failure to obtain marketing approval for a product candidate will prevent us from commercializing the product candidate in a given jurisdiction. We have not received approval to market any product candidates from regulatory authorities in any jurisdiction and it is possible that none of the product candidates we may seek to develop in the future will ever obtain regulatory approval. We have no experience in filing and supporting the applications necessary to gain marketing approvals and expect to continue to rely on third-party CROs or regulatory consultants to assist us in this process. Securing regulatory approval requires the submission of extensive preclinical and clinical data and supporting information to the various regulatory authorities for each therapeutic indication to establish the product candidate’s safety and effectiveness. Securing regulatory approval also requires the submission of information about the product manufacturing process to, and inspection of manufacturing facilities by, the relevant regulatory authority. Any product candidates we develop may not be effective, may be only moderately effective, or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude our obtaining marketing approval or prevent or limit commercial use.

If the FDA or comparable foreign regulatory authorities approve generic or biosimilar versions of any of our products that receive marketing approval, or if we do not obtain the exclusivity periods for our approved products that we hope to achieve, the sales of our products could be adversely affected.

If and when approved, our product candidates may face competition from ANDA or 505(b)(2) product candidates referencing our drug product and from biosimilars product candidates referencing our biological product. Certain ANDAs, and certain biosimilar products that are deemed under applicable laws to be “interchangeable with” our biological product, once approved, may be substituted for our product candidates, subject to applicable state laws.

We may pursue pediatric exclusivity for one or more of our product candidates but may not succeed in obtaining it. There is also a risk that a competitor may achieve pediatric exclusivity that would delay any potential approvals of our product candidates. In the United States, the FDA has the authority to award additional exclusivity for approved products where the sponsor conducts specified testing on pediatric or adolescent populations upon the written request of the FDA. If granted, pediatric exclusivity may add six months to certain patents or regulatory exclusivity periods for an approved drug, and to regulatory exclusivity periods for an approved biological product.drug. In the EU, pediatric studies are also incentivized by the reward of additional exclusivity. PediatricPaediatric Investigation Plans (“PIPs”) must be agreed with the PediatricPaediatric Committee of the EMA, unless a waiver or deferral applies with respect to the product. Where an application for a marketing authorization is submitted in respect of a medicinal product designated as an orphan medicinal product and that application contains the results of studies conducted in compliance with an approved PIP, market exclusivity for that orphan medicinal product may be extended by two years. Where an application for a marketing authorization is submitted in respect of a medicinal product that is not designated as an orphan medicinal product and that application contains the results of studies conducted in compliance with an approved PIP, it may be possible to obtain a six monthsix-month extension of a supplementary protection certificate extending patent protection for a medicinal product.

We rely upon a combination of patents, patent applications, trade secret protection and confidentiality agreements to protect the intellectual property related to our product candidates, platform technology and know-how. The patent position of biotechnology companies is generally uncertain, because it involves complex legal and factual considerations. The standards applied by the USPTO and foreign patent offices in granting patents are not always applied uniformly or predictably. For example, there is no uniform worldwide policy regarding patentable subject matter or the scope of claims allowable in biotechnology patents. In addition, some countries do not grant patent claims directed to methods of treating humans, and in these countries patent protection may not be available at all to protect our product candidates. The patent applications that we own or in-license may fail to result in issued patents with claims that cover our product candidates in the United States or in other countries.

The patent prosecution process is expensive and time consuming, and our current or future licensors, licensees or collaborators may not be able to prepare, file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner. Moreover, in some circumstances, we may not have the right to control the preparation, filing and prosecution of patent applications, or to maintain the patents, covering technology that we license from or license to third parties, making us reliant on our licensors, licensees or collaborators. Therefore, these patents and patent applications may not be prosecuted and enforced in a manner consistent with the best interests of the Company’sour business. If our current or future licensors, licensees or collaborators fail to establish, maintain or protect such patents and other intellectual property rights, such rights may be lost or impaired. If our licensors, licensees or collaborators are not fully cooperative or disagree with the Companyus as to the prosecution, maintenance or enforcement of any patent rights, such patent rights could be compromised.

We are a party to a number of license agreements that are important to our business, and we may enter into additional license agreements in the future. Certain of our in-licensed intellectual property covers, or may cover, certain of our product candidates including pemvidutide. Our existing license agreements impose, and we expect that future license agreements will impose, various diligence, milestone payment, royalty and other of our obligations. If there is any conflict, dispute, disagreement or issue of non-performance between the Companyus and our licensing partners regarding our rights or obligations under the license agreements, including any such conflict, dispute or disagreement arising from our failure to satisfy payment obligations under any such agreement, we may owe damages, our licensor may have a right to terminate the affected license, and our ability to utilize the affected intellectual property in our product discovery and development efforts and our ability to enter into collaboration or marketing agreements for an affected product candidate may be adversely affected.

In addition to the protection afforded by patents, we rely on confidentiality agreements to protect trade secrets and proprietary know-how that may not be patentable or that we may elect not to patent, processes for which patents are difficult to enforce and any other elements of our technology and development processes that involve proprietary know-how, information or technology that is not covered by patents. In particular, we seek to protect our proprietary technology and processes, in part, by entering into confidentiality agreements with our employees, consultants, outside scientific advisors, contractors and collaborators. These agreements require that all confidential information developed by the individual or made known to the individual by the Companyus during the course of the individual’s relationship with us be kept confidential and not disclosed to third parties. We also enter into agreements with our employees that provide that any inventions conceived by the individual in the course of rendering services to the Companyus shall be our exclusive property. However, we may not obtain these agreements in all circumstances, and individuals with whom we have these agreements may not comply with their terms. Although we use reasonable efforts to protect our know-how, our employees, consultants, contractors or outside scientific advisors might intentionally or inadvertently disclose our know-how or other proprietary information to competitors. In addition, competitors may otherwise gain access to our know-how or independently develop substantially equivalent information and techniques.

Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented, declared generic or determined to be infringing on other marks. We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition among potential partners or customers in our markets of interest. At times, competitors may adopt trade names or trademarks similar to those of the Company’s,ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. In addition, there could be potential trade name or trademark infringement claims brought by owners of other registered trademarks or trademarks that incorporate variations of our registered or unregistered trademarks or trade names. For example, we have experienced threatened or actual opposition for two trademarks that we were pursuing. We decided to discontinue our use of one of those trademarks, and the other matter was resolved on favorable terms. Although these matters have been resolved on terms that did not materially harm the Company,us, we may become subject to other trademark challenges in the future. If we are unable to establish long-term name recognition based on our trademarks and trade names, then we may not be able to compete effectively, and our business may be adversely affected.

Risks Related to Commercialization of the Company’sour Product Candidates

We rely on, and expect to continue to rely on, third parties to manufacture our product candidates and related materials for our products, if approved, as well as for our clinical trials and preclinical studies, and these third parties may not perform satisfactorily. The failure of these third parties to successfully carry out their contractual duties or meet expected deadlines could hinder our ability to commercialize or obtain marketing approval for our current and future candidates in a timely manner or at all.

We do not have any manufacturing facilities or personnel, and we rely on, and expect to continue to rely on, third-party manufacturers and suppliers to manufacture and supply vaccines, drug substance and drug product for our preclinical studies and clinical trials,trials and on related materials, such asof pemvidutide. We rely on a small number of third-party manufacturers and suppliers to manufacture and supply bulk drug substance and drug product and fill finished vaccines for our initial clinical trials. This reliance on a small number of third parties increases the risk that we will not have sufficient quantities of our product candidates or other products needed for our preclinical studies and clinical trials, or that such quantities will be manufactured for us at an acceptable cost or quality, which could delay, prevent or impair our development or commercialization efforts.

Any of these events could lead to preclinical study and clinical trial delays or failure to obtain regulatory approval or affect our ability to successfully commercialize future products. Some of these events could be the basis for FDA or other regulatory authority action, including untitled letters and warning letters, clinical holds, fines, injunctions, civil penalties, license revocations, recall, seizure, total or partial suspension of production, or criminal penalties.

Third-party manufacturers may not be able to comply with applicable cGMP, regulations or similar regulatory requirements outside the United States. Our failure, or the failure of our third-party manufacturers, to comply with applicable regulations could result in sanctions or enforcement actions being imposed, including warning letters, untitled letters, clinical holds, fines, injunctions, civil penalties, delays, license revocation, seizures or recalls of product candidates or products, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of our product candidates.

Our third-party manufacturers may be subject to damage or interruption from, among other things, fire, natural or man-made disaster, power loss, telecommunications failure, unauthorized entry, computer viruses, denial-of-service attacks, acts of terrorism, human error, vandalism or sabotage, financial insolvency, bankruptcybankruptcy, andregulatory action or similar events.

Our current and future product candidates and any products that we may develop may compete with otherothers’ product candidates and products for access to manufacturing facilities. There are a limited number of manufacturers that operate under cGMP regulations and that might be capable of manufacturing for us. Any performance failure on the part of our existing or future manufacturers could delay clinical development or marketing approval. We have limited arrangements in place for redundant supply or a second source for bulk drug substance. If our current contract manufacturers cannot perform as agreed, we may be required to replace such manufacturers, and it may prove very difficult and time consuming to identify potential alternative manufacturers who could manufacture our product candidates. Accordingly, we may incur added costs and delays in identifying and qualifying any such replacement.

Altimmune, Inc. is a clinicallate stageclinical-stage biopharmaceutical company focused on developing treatmentsnovel therapies for obesity, metabolic andserious liver diseases. Our lead product candidate, pemvidutide (formerly known as ALT-801), is a novel,balanced investigational,1:1 peptide-based glucagon/GLP-1/glucagon dual receptor agonist. Pemvidutide is currentlyagonist in clinical development for obesitythe treatment of MASH, AUD and metabolic associated steatohepatitis (MASH).ALD. We may also expect to pursue additional indications for pemvidutide that leverage theits differentiated clinical profile of pemvidutide.profile. Except where the context indicates otherwise, references to “we,” “us,” “our,” “Altimmune”, or the “Company” refer to the company and its subsidiaries.

A significant portion of our research and development efforts have been related to the development of pemvidutide and HepTcell. The development of HepTcell was discontinued on March 27, 2024.pemvidutide. We do not allocate personnel-related costs, costs associated with our general research platform improvements, depreciation or other indirect costs to specific programs.

Research and development expenses for the years ended December 31, 20242025 and 20232024 consisted primarily of expenses related to product candidate development. Research and development expenses for the years ended December 31, 2024 and 2023 aredevelopment, summarized as follows:

General and administrative expenses increased by $2.8$7.1 million, or 16%,34%, during the year ended December 31, 20242025 as compared to the year ended December 31, 2023,2024, primarily due to a $2.7 million increase in professional services and a $4.9 million increase in stock compensation and other labor-related expenses, including the $1.0$1.4 million incrementalseverance stock-basedcosts compensationfor expenseour becauseformer of modifications of stock awards (see Note 9).executives.

Total other income (expense), net increaseddecreased by $0.6$2.4 million during the year ended December 31, 20242025 as compared to the year ended December 31, 2023,2024. The net decrease was primarily due to a $0.7$1.6 million increase in interest expense related to our Term Loan and a $0.5 million decrease in interest income earned on our cash equivalents and short-term investments.

Our primary sources of cash for the year ended December 31, 20242025 were from equity transactions, debt, interest and dividendsincome from our money market funds and short-term investments, and proceeds from maturity of our short-term investments. Our cash, cash equivalents, restricted cash and short-term investments were $131.9$273.5 million as of December 31, 2024.2025. We believe, based on the operating cash requirements and capital expenditures expected for 20252026 and 2026,2027, our cash on hand as of December 31, 2024,2025, together with expected cash receipts from our equity transactions and research and development incentives, are sufficient to fund operations for at least a twelve-month period from the issuance date of our December 31, 20242025 consolidated financial statements.

We have not generated any revenues from the sale of any products to date, and there is no assurance of any future revenues from product sales. We have incurred significant losses since we commenced operations. As of December 31, 2024,2025, we had an accumulated deficit of $561.4$649.5 million. In addition, we have not generated positive cash flows from operations. We have had to rely on a variety of financing sources, including the issuance of debt and equity securities. As capital resources are consumed to fund our research and development activities, we may require additional capital beyond our currently anticipated amounts. In order to address our capital needs, including our planned clinical trials, we must continue to actively pursue additional equity or debt financing, government funding, and monetization of our existing programs through partnership arrangements or sales to third parties.

On FebruaryNovember 28,13, 2023,2025, we filed a shelf registration statement on Form S-3ASR,S-3, as amended, which was declared effective immediately.on December 5, 2025. This shelf registration allowedallows us to offer and sell anyup amountto $400.0 million of our common stock, preferred stock, debt securities, warrants, rights and units (the “2023November 2025 Shelf”). for a period of 3 years from effectiveness.

On FebruaryNovember 28,6, 2023,2025, we entered into an Equity Distribution Agreement (the “2023November 2025 Agreement”) with EvercoreLeerink Group L.L.C., JMP SecuritiesPartners LLC and B. Riley Securities, Inc., serving as sales agents,agent, with respect to an at-the-market offerings program under which we offeredmay offer and soldsell shares of our common stock having an aggregate offering price of up to $150.0$200.0 million through the Salesales Agentsagent from the 2023February 2025 Shelf. Since inception through December 31, 2024,2025, we raised approximately $96.6$25.4 million in net proceeds.proceeds, with $174.2 million remaining available to be sold under the November 2025 Agreement.

Net cash used in operating activities was $79.8$67.5 million for the year ended December 31, 20242025 compared to $75.8$79.8 million during the year ended December 31, 2023.2024. Our sources of cash provided by operations during the year ended December 31, 20242025 were primarily cash receipts of research and development incentive credits. The primary uses of cash from our operating activities include payments for labor and labor-related costs, professional fees, research and development costs associated with our clinical trials and other general corporate expenditures. The increasedecrease in cash used in operating activities of $4.0$12.3 million was due to a $16.8$10.0 million increasedecrease in net loss as adjusted for noncash items,items partially offset byand a $12.8$2.3 million change in working capital accounts.

This Quarterly Report on Form 10-Q contains forward-looking statements that involve substantial risks and uncertainties. The words “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “may,” “will,” “should,” “could,” “target,” “strategy,” “intend,” “project,” “guidance,” “likely,” “usually,” “potential,” or the negative of these words or variations of such words, similar expressions, or comparable terminology are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. There are a number of important risks and uncertainties that could cause our actual results to differ materially from those indicated by forward-looking statements. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate, and management’s beliefs and assumptions. These statements are not guarantees of future performance and involve certain risks, uncertainties and assumptions that are difficult to predict and may cause our actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by any forward-looking statements. A further list and description of risks, uncertainties and other factors that could cause actual results or events to differ materially from the forward-looking statements that we make is included in the cautionary statements herein and in our other filings with the SEC, including those set forth under Part I, Item 1A, Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2025. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that we may make.

On April 24, 2026, we completed an underwritten public offering pursuant to which we raised approximately $211.2$211.1 million in net proceeds from the issuance of a combination of common stock, common stock warrants and pre-funded warrants. The common stock and pre-funded warrants were sold in combination with an accompanying common stock warrant to purchase one share of common stock (or pre-funded warrant in lieu thereof) issued for each share of common stock or pre-funded warrant sold. The gross proceeds could increase by another $225 million if all the warrant holders exercise their common stock warrants. See Note 12.7. SubsequentStockholders’ EventsEquity for additional information.

In January 2026, we announced that the U.S. Food and Drug Administration (“FDA”) granted Breakthrough Therapy Designation to pemvidutide for the treatment of MASH based on the data from the IMPACT Phase 2b trial at 24 weeks in which we observed statistically significant MASH resolution and positive trends in fibrosis improvement. In December 2025, the Company announced positive 48-week data from the IMPACT trial, including statistically significant improvements observed in key non-invasive markers of fibrosis and inflammation, such as Enhanced Liver Fibrosis (“ELF”) and Liver Stiffness Measurement (“LSM”), which are strongly associated with MASH histologic changes, and noted continued reductions from 24-week timepoint. Additional weight loss was observed from 24 weeks to 48 weeks at the 1.8 mg dose with no evidence of plateauing. We also observed greater adherence to treatment in the pemvidutide arms, as shown by lower discontinuation rates than the placebo group which may be attributable to the favorable safety and tolerability profile of pemvidutide. With the positive 48-week data from the IMPACT trial, FDA designation and having secured the necessary financing, we arebegan inpreparing the start up phase of the execution offor our PERFORMA Phase 3 trial in MASH. We have aligned with the FDA following an End of Phase 2 Meeting, and submitted the final study protocol to the FDA. Further, we received scientific advice from the European Medicines Agency and MHRAMedicines and Healthcare products Regulatory Agency (UK) and selected a global CROContract Research Organization with deep experience running global MASH pivotal trials. The global pivotal PERFORMA Phase 3 trial will test two doses of pemvidutide over an estimated duration of approximately 60 months for liver-related events supporting final approval, including an interim analysis after 52 weeks to support with biopsybiopsy-based based-endpointsendpoints to support an accelerated approval. We are planning to initiate the PERFORMA Phase 3 trial in the second half of 2026.

RECLAIM, a Phase 2 trial evaluating the efficacy and safety of pemvidutide in subjects with AUD, is a randomized, placebo-controlled trial conducted across approximately 15 sites in the United States, targeting enrollment of approximately 100 subjects. Subjects will be randomized 1:1 to receive either 2.4 mg pemvidutide or placebo weekly for 24 weeks. The trial’s primary endpoint is a change in alcohol consumption, measured by the change from baseline in the average number of heavy drinking days (“HDD”) per week measured at Week 24, with the key secondary endpoints including the proportion of subjects achieving a 2-level reduction in World Health Organization (“WHO”) risk drinking level and the absolute change from baseline in average levels of phosphatidylethanol (“PEth”), a serum biomarker of alcohol intake.

In August 2025, the FDA granted Fast Track designation to pemvidutide for the treatment of AUD. Enrollment in the RECLAIM Phase 2 trial in AUD was completed in November 2025, several months ahead of schedule, and we are on track to complete the 24-week treatment period and announce topline results in the third quarter 2026.schedule.

RESTORE, a Phase 2 trial evaluating the efficacy and safety of pemvidutide in subjects with ALD, is a randomized, placebo-controlled trial enrolling approximately 100 patients across 34 sites in the United States. Subjects will be randomized 1:1 to receive either 2.4mg2.4 mg pemvidutide or placebo weekly for 48 weeks. The trial’s primary endpoint is the change from baseline in Liver Stiffness Measurement (“LSM”) by vibration-controlled transient elastography (“VCTE”)and will be assessed in a hierarchical manner at Week 48 and then at Week 24. Main secondary endpoints include the change from baseline in LSM by VCTE at Week 48, changes in ELF score at Weeks 24 and 48, and changes in alcohol consumption and body weight at the same time points. WeIn expectJuly to2026, completewe completed enrollment in the RESTORE Phase 2 trial in the third quarter of 2026.ALD.

The United States recently imposed reciprocal and additional tariffs on many countries around the world. Such tariffs and counter tariffscounter-tariffs by other countries against the U.S. have been causing uncertainties in the global markets. If the tariffs and counter tariffscounter-tariffs continue or escalate, they could have a significant negative effect on the global economy or on our operations, including continued inflationary pressures on raw materials, supply chain and logistics disruptions, and volatility in the capital markets, foreign exchange rates and interest rates.

We are closely monitoring the impact of the ongoing military conflict in the Middle East, including the recent conflict involving the U.S., Israel and Iran, on our business as the conflict has caused increased economic uncertainty and operational complexity globally. While we have no direct exposure to the Middle East, and do not at the momentcurrently believe the situation will have a material impact on our operating results, we are monitoring any broader economic impact from the situation. Should the conflict continue or escalate, it could have a significant negative effect on the global economy or on our operations, including continued inflationary pressures on raw materials, oil and energy prices and clinical trial costs, supply chain and logistics disruptions, volatility in foreign exchange rates and interest rates and heightened cybersecurity threats.

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

Research and development expenses for the three months ended MarchJune 31,30, 2026 and 2025 consisted primarily of expenses related to product candidate development, summarized as follows:

The increase in research and development expenses was due primarily to the ongoing ALD and AUD trialstrial as well as the startup costs for PERFORMA Phase 3 trial in MASH,MASH and the non-project costs to support these activities, partially offset by the decrease in expenses related to completion of the RECLAIM Phase 2 trial in AUD and IMPACT Phase 2b trial in MASH, which waswere ongoing in the firstsecond three monthsquarter of 2025.

General and administrative expenses increased by $2.1$1.9 million, or 34%,33%, for the three months ended MarchJune 31,30, 2026, as compared to the three months ended MarchJune 31,30, 2025.2025, The increase isprimarily due primarily to a $1.3 million increase in compensation expense, including $0.6 million in severance costs for one of our former executive officers and a $0.6 million increase in compensation expenses and a $1.1 million increase in expenses for professional service fees.services.

Total other income (expense), net increased by $0.1$2.6 million, or 8%,339%, for the three months ended MarchJune 31,30, 2026, as compared to the three months ended MarchJune 31,30, 2025. The net increase iswas primarily due to a $1.4$3.4 million increase in interest income earned on our cash equivalents and short-terminvestments investments,in marketable securities, partially offset by a $1.1$0.8 million increase in interest expense onrelated to our Term Loan.

Our primary sources of cash during the threesix months ended MarchJune 31,30, 2026,2026 were from equity transactions, interest from our money market funds and short-terminvestments investments,in marketable securities, and proceeds from maturity of our short-term investments. Our cash, cash equivalents, restricted cash and short-term investments were $331.6$326.3 million as of MarchJune 31,30, 2026. In addition, we had $192.3 million in long-term investments. We believe, based on the operating cash requirements and capital expenditures expected for 2026 and 2027, our cash on hand as of MarchJune 31,30, 2026,2026 together with expected cash receipts from equity transactions finalized after March 31, 2026, areis sufficient to fund operations for at least a twelve-month period from the issuance date of our MarchJune 31,30, 2026 consolidated financial statements.

We have not generated any revenues from the sale of any products to date,date and there is no assurance of any future revenues from product sales. We have incurred significant losses since we commenced operations. As of MarchJune 31,30, 2026, we had an accumulated deficit of $672.0$694.9 million. In addition, we have not generated positive cash flows from operations. We have had to relyrelied on a variety of financing sources, including the issuance of debt and equity securities. As capital resources are consumed to fund our research and development activities, we may require additional capital beyond our currently anticipated amounts. In order to address our capital needs, including our planned clinical trials, we must continue to actively pursue additional equity or debt financing, and monetization of our existing programs through partnership arrangements or sales to third parties.

On November 6, 2025, we entered into an Equity Distribution Agreement (the “November 2025 Agreement”) with Leerink Partners LLC serving as sales agent, with respect to an ATM offerings program under which we may offer and sell shares of our common stock having an aggregate offering price of up to $200.0 million through the sales agent from the February 2025 Shelf. Since inception through MarchJune 31,30, 2026, we raised approximately $34.2 million in net proceeds, with $165.3 million remaining available to be sold under the November 2025 Agreement.

On February 27, 2025, we entered into an Equity Distribution Agreement (the “February 2025 Agreement”) with Leerink Partners LLC, Piper Sandler & Co. and Stifel, Nicolaus & Company, Incorporated, serving as sales agents, with respect to an ATM offerings program under which we offered and sold shares of our common stock having an aggregate offering price of up to $150.0 million through the salesales agents from the February 2025 Shelf. Since inception, through the termination of the February 2025 Agreement in November 2025, we raised approximately $118.3 million in net proceeds.

On February 28, 2023, we entered into an Equity Distribution Agreement (the “2023 Agreement”) with Evercore Group L.L.C., JMP Securities LLC and B. Riley Securities, Inc., serving as sales agents, with respect to an ATM offerings program under which we offered and sold shares of our common stock having an aggregate offering price of up to $150.0 million through the salesales agents from the 2023 Shelf. Since inception through the termination of the 2023 Agreement in February 2025, we raised approximately $126.8 million in net proceeds.

On April 22, 2026, we entered into an underwriting agreement with certain underwriters pursuant to which we offered and sold securities consisting of (i) 64,250,000 shares of our common stock and accompanying common stock warrants to purchase an aggregate of 64,250,000 shares of common stock (or pre-funded warrants in lieu thereof) and (ii) in lieu of common stock, to certain investors that so choose, pre-funded warrants to purchase an aggregate of up to 10,750,000 shares of its common stock and accompanying common stock warrants to purchase an aggregate of 10,750,000 shares of common stock (or pre-funded warrants in lieu thereof), at an exercise price of $0.001 per pre-funded warrant. The common stock and pre-funded warrants were sold in combination with an accompanying common stock warrant to purchase one share of common stock (or pre-funded warrant in lieu thereof) issued for each share of common stock or pre-funded warrant sold. The accompanying common stock warrant has an exercise price of $3.00 per share and is immediately exercisable from the date of issuance. The combined offering price of each share of common stock and accompanyaccompanying common stock warrant is $3.00. The combined offering price of each pre-funded warrant and accompanying common stock warrant is $2.999. The net proceeds of the April 2026 Offering were approximately $211.2$211.1 million, after deducting the underwriting discount and estimated offering expenses. If all of the common stock warrants sold in the April 2026 Offering were to be exercised in cash at their exercise price, we would receive additional gross proceeds of $225 million. All shares of common stock, pre-funded warrants and common stock warrants offered and sold in the April 2026 Offering were issued pursuant to the February 2025 Shelf, the November 2025 Shelf and a related registration statement that was filed with the SEC on April 22, 2026 pursuant to Rule 462(b) under the Securities Act of 1933, as amended, and became automatically effective upon filing as permitted under Rule 429.

The following table provides information regarding our cash flows for the threesix months ended MarchJune 31,30, 2026 and 2025:

Net cash used in operating activities was $20.9$45.2 million for the threesix months ended MarchJune 31,30, 2026,2026 compared to $16.8$36.2 million during the threesix months ended MarchJune 31,30, 2025. The primary uses of cash from our operating activities includeincluded payments for labor and labor-related costs, professional fees, research and development costs associated with our clinical trials, and other general corporate expenditures. The increase in cash used in operations of $4.1$9.0 million year over year iswas due to changes in working capital accounts of $2.1$5.9 million and an increase in net loss as adjusted for non-cash items of $2.0$3.1 million.

Net cash used in investing activities was $3.7$225.1 million,million for the threesix months ended MarchJune 31,30, 2026 compared to $5.1$96.0 million net cash provided by investing activities during the six months ended June 30, 2025. The net cash used in investing activities during the threesix months ended MarchJune 31, 2025. The cash used in investing activities during the three months ended March 31,30, 2026 was primarily due to thea $332.4 million purchase of $43.3investments millionin ofmarketable short-term investments,securities, partially offset by $39.6a $107.3 million in proceeds from salesales and maturities of short-termthese investments. The net cash usedprovided inby investing activities during the threesix months ended MarchJune 31,30, 2025,2025 was primarily due to a $43.1 million purchase of short-term investments, partially offset by $38.0$143.6 million in proceeds from salesales and maturities of short-terminvestments investments.in marketable securities, partially offset by a $47.6 million purchase of investments in marketable securities.

Net cash provided by financing activities was $78.5$289.5 million during the threesix months ended MarchJune 31,30, 2026,2026 compared to $34.1$86.4 million net cash provided by financing activities during the threesix months ended MarchJune 31,30, 2025. The net cash provided by financing activities during the threesix months ended MarchJune 31,30, 2026,2026 was primarily the result of the receipt of $211.1 million in net proceeds from the April 2026 Offering, $70.3 million in net proceeds from the January 2026 RDO, $8.7 million in net proceeds from the issuance of common stock from our ATM offerings program, net of deferred offering costs, $0.2 million in proceeds from proceeds from the sale of shares under the ESPP, partially offset by $0.7 million net paymentpayments for tax withholding obligations related to share-based compensation. The net cash provided by financing activities during the threesix months ended MarchJune 31,30, 2025,2025 was primarily the result of the receipt of $34.6$72.3 million in net proceeds from the issuance of common stock from our ATM offerings programprogram, $14.6 million in net proceeds from the term loan, and $0.2 million in proceeds from the sale of shares under the ESPP, partially offset by $0.7 million paymentnet payments for tax withholding obligations related to share-based compensation.

We have financed our operations to date principally through our equity offerings, debt and proceeds from issuances of our preferred stock, common stock and warrants. As of MarchJune 31,30, 2026, we had $97.6$63.1 million of cash, cash equivalents and restricted cash and $233.9$455.5 million of investments in marketable securities, of which $263.3 million is in short-term investments. Accordingly, management believes that we have sufficient capital to fund our plan of operations for at least a twelve-month period from the issuance date of our MarchJune 31,30, 2026 consolidated financial statements. In order to address our long-term capital needs, including our planned clinical trials, in April 2026, we raised approximately $211.2$211.1 million in net proceeds from the April 2026 Offering. If all of the common stock warrants issued in the April 2026 Offering are exercised, we would receive an additional $225 million in gross proceeds.

Except as disclosed above, there have been no changes in our critical accounting policies and significant judgment and estimates as disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025.