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What changed in Altimmune, Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Altimmune, Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+540 added−484 removedSource: 10-K (2026-03-06) vs 10-K (2025-02-27)

Top changes in Altimmune, Inc.'s 2025 10-K

540 paragraphs added · 484 removed · 305 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

83 edited+87 added−93 removed209 unchanged
Biggest changeOur Strategy Key elements of our strategy include the following: ● Develop pemvidutide for MASH as well as other indications that benefit from the dual activity of GLP-1 and glucagon; ● Pursue partnering of pemvidutide to advance the obesity program and indication; ● Continue to build our experience and capabilities to support the development and commercialization of pemvidutide; ● Research and develop alternative formulations, doses, and presentations of pemvidutide for the benefit of patients; and ● Leverage our knowledge in liver and cardiometabolic disease by developing, acquiring, or in-licensing additional investigational candidates.
Biggest changeKey elements of our strategy include the following: ● Initiate the registrational Phase 3 development program in MASH that, provided safety and efficacy are established, provides for an accelerated approval based on data obtained after one year of treatment; ● Continue development of other liver-related indications such as AUD and ALD that may benefit from the dual activity of glucagon and GLP-1a; ● Continue to build and develop our experience and capabilities to support the development and commercialization of pemvidutide; ● Research and develop alternative formulations, doses, and presentations of pemvidutide for the benefit of patients; and ● Assess strategic partnerships and licensing opportunities to help accelerate the development of pemvidutide and achieve our goals.
EU Directive 2001/83/EC allows for clinical trials conducted outside the EU to be taken into consideration during the review of a marketing authorization in the EU if such trials have been designed, implemented and reported based on principles equivalent to those of the Clinical Trials Regulation, including with regard to good clinical practice and ethical principles.
EU Directive 2001/83/EC allows for clinical trials conducted outside the EU to be taken into consideration during the review of a marketing authorization in the EU if such trials have been designed, implemented and reported based on principles equivalent to those of the EU Clinical Trials Regulation, including with regard to good clinical practice and ethical principles.
Drug and Biological Products Development Process The process required by the FDA before a drug or biological product may be marketed in the United States generally involves the following: ● completion of preclinical laboratory tests and animal studies according to applicable good laboratory practices (“GLP”), applicable requirements for the humane use of laboratory animals, such as the Animal Welfare Act or other applicable regulations; ● submission to the FDA of an application for an IND which must become effective before human clinical trials may begin; ● obtaining approval by an independent Institutional Review Board (“IRB”) at each clinical site before a clinical trial may be initiated at that site; ● performance of adequate and well-controlled human clinical trials according to the FDA’s regulations commonly referred to as good clinical practices (“GCP”) and any additional requirements for the protection of human research subjects and their health information, to establish the safety and efficacy of the proposed product for its intended use; ● submission to the FDA of a new drug application (“NDA”) or biologics license application (“BLA”) for marketing approval that includes substantial evidence of safety, purity and potency from results of clinical trials, as well as the results of preclinical testing, detailed information about the chemistry, manufacturing and controls, and proposed labeling and packaging for the product candidate; 16 Table of Contents ● review of the product candidate by an FDA advisory committee, if applicable; ● satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the product candidate is produced to assess compliance with cGMP and to confirm that the facilities, methods and controls are adequate to assure the product candidate’s identity, strength, quality and purity; ● satisfactory completion of potential FDA audits of the preclinical study and clinical trial sites that generated the data in support of the NDA or BLA; and ● FDA review and approval, or licensure, of the NDA or BLA, including agreement on post-marketing commitments, if applicable.
Drug and Biological Products Development Process The process required by the FDA before a drug or biological product may be marketed in the United States generally involves the following: ● completion of preclinical laboratory tests and animal studies according to applicable good laboratory practices (“GLP”), applicable requirements for the humane use of laboratory animals, such as the Animal Welfare Act or other applicable regulations; ● submission to the FDA of an IND application which must become effective before human clinical trials may begin; ● obtaining approval by an independent Institutional Review Board (“IRB”) at each clinical site before a clinical trial may be initiated at that site; ● performance of adequate and well-controlled human clinical trials according to the FDA’s regulations commonly referred to as good clinical practices (“GCP”) and any additional requirements for the protection of human research subjects and their health information, to establish the safety and efficacy of the proposed product for its intended use; ● submission to the FDA of a new drug application (“NDA”) or biologics license application (“BLA”) for marketing approval that includes substantial evidence of safety, purity and potency from results of clinical trials, as well as the results of preclinical testing, detailed information about the chemistry, manufacturing and controls, and proposed labeling and packaging for the product candidate; ● review of the product candidate by an FDA advisory committee, if applicable; ● satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the product candidate is produced to assess compliance with cGMP and to confirm that the facilities, methods and controls are adequate to assure the product candidate’s identity, strength, quality and purity; ● satisfactory completion of potential FDA audits of the preclinical study and clinical trial sites that generated the data in support of the NDA or BLA; and ● FDA review and approval, or licensure, of the NDA or BLA, including agreement on post-marketing commitments, if applicable.
Use of pemvidutide in methods with improved tolerability, dosing and therapeutic regimens is further covered in pending applications in the United States, Europe, Japan and Korea, as well as other commercially relevant jurisdictions, which are owned by us and not subject to the Mederis IP License Agreement.
Use of pemvidutide in methods with improved tolerability, dosing, dosing formulations and therapeutic regimens is further covered in pending applications in the United States, Europe, Japan and Korea, as well as other commercially relevant jurisdictions, which are owned by us and not subject to the Mederis IP License Agreement.
As another example, the Inflation Reduction Act of 2022 (“IRA”) includes several provisions that will impact our business to varying degrees, including provisions that create a $2,000 out-of-pocket cap for Medicare Part D beneficiaries, impose new mandatory discounts from manufacturers under Medicare Part D, allow the U.S. government to negotiate Medicare Part B and Part D pricing for certain high-cost single-source drugs and biologics without generic or biosimilar competition, and require companies to pay rebates to Medicare for drug prices that increase faster than inflation.
As another example, the Inflation Reduction Act of 2022 (“IRA”) includes several provisions that will impact our business to varying degrees, including provisions that create a $2,000 out-of-pocket cap for Medicare Part D beneficiaries, impose new mandatory discounts from manufacturers under Medicare Part D, allow the U.S. government to negotiate Medicare Part B and Part D pricing for certain high-cost single-source drugs and biologics without generic competition, and require companies to pay rebates to Medicare for drug prices that increase faster than inflation.
Where a marketing authorization in respect of an orphan medicinal product is granted, the European Commission, EMA and the competent authorities of the EU member states shall not, for a period of ten years, accept another application for a marketing authorization or grant a marketing authorization or accept an application to extend an existing authorization, for the same therapeutic indication, in respect of a similar medicinal product, to an authorized orphan product unless: (i) the holder of the marketing authorization for the original orphan medicinal product has given its consent to the second applicant; (ii) the holder of the marketing authorization for the original orphan medicinal product is unable to supply sufficient quantities of the medicinal product; or (iii) the second applicant can establish the its product is safer, more effective or otherwise clinically superior than the authorized orphan product.
Where a marketing authorization in respect of an orphan medicinal product is granted, the European Commission, EMA and the competent authorities of the EU member states shall not, for a period of ten years, accept another application for a marketing authorization or grant a marketing authorization or accept an application to extend an existing authorization, for the same therapeutic indication, in respect of a similar medicinal product, to an authorized orphan product unless: (i) the holder of the marketing authorization for the original orphan medicinal product has given its consent to the second applicant; (ii) the holder of the marketing authorization for the original orphan medicinal product is unable to supply sufficient quantities of the medicinal product; or (iii) the second applicant can establish that its product is safer, more effective or otherwise clinically superior to the authorized orphan product.
The claims are directed to GLP-1/glucagon dual agonist peptides conjugated to a surfactant and their use to treat metabolic syndrome, obesity and other related diseases.
The claims are directed to GLP-1/glucagon dual agonist peptides conjugated to a surfactant and their use to treat metabolic syndrome and other related diseases.
In addition, discovery of problems with a product or the failure to comply with applicable requirements may result in restrictions on a product, manufacturer or holder of an approved NDA or BLA, including withdrawal or recall of the product from the market or other voluntary, FDA-initiated or judicial action, including warning letters, fines, injunctions, civil penalties, license revocations, seizure, total or partial suspension of production or criminal penalties, any of which could delay or prohibit 20 Table of Contents further marketing.
In addition, discovery of problems with a product or the failure to comply with applicable requirements may result in restrictions on a product, manufacturer or holder of an approved NDA or BLA, including withdrawal or recall of the product from the market or other voluntary, FDA-initiated or judicial action, including warning letters, fines, injunctions, civil penalties, license revocations, seizure, total or partial suspension of production or criminal penalties, any of which could delay or prohibit further marketing.
To find out whether a product can be evaluated via the centralized procedure, applicants should submit an eligibility request to the EMA, including by a justification of eligibility for evaluation under the centralized procedure. ● National marketing authorizations, which are issued by the competent authorities of the member states of the EEA and only cover their respective territory, are available for drugs not falling within the mandatory scope of the centralized procedure.
To find out whether a product can be evaluated via the centralized procedure, applicants should submit an eligibility request to the EMA, including by a justification of eligibility for evaluation under the centralized procedure. ● National marketing authorizations, which are issued by the competent authorities of the member states of the EEA and only cover their respective territory, are available for medicinal products not falling within the mandatory scope of the centralized procedure.
Moreover, there are no safe harbors for many common practices, such as educational and research grants, charitable donations, product support and patient assistance programs. Violations of the Anti-Kickback Law may be punished by civil and criminal penalties, damages, fines, or exclusion from participation in federal health care programs like Medicare and Medicaid.
Moreover, there are no safe harbors for many common practices, such as educational and research grants, charitable donations, product support and patient assistance programs. Violations of the Anti-Kickback Law may be punished by civil and criminal penalties, damages, fines, or exclusion from participation in 21 Table of Contents federal health care programs like Medicare and Medicaid.
Sales of these or other product candidates that we may identify will depend substantially, both domestically and abroad, on the extent to which the costs of our product candidates will be paid by health maintenance, managed care, pharmacy benefit and similar healthcare management organizations, or reimbursed by government health administration authorities, private health coverage 26 Table of Contents insurers and other third-party payers.
Sales of these or other product candidates that we may identify will depend substantially, both domestically and abroad, on the extent to which the costs of our product candidates will be paid by health maintenance, managed care, pharmacy benefit and similar healthcare management organizations, or reimbursed by government health administration authorities, private health coverage insurers and other third-party payers.
Before approving an NDA or BLA, the FDA will inspect the facilities at which the product is manufactured. The FDA will not approve the NDA or BLA unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required 19 Table of Contents specifications.
Before approving an NDA or BLA, the FDA will inspect the facilities at which the product is manufactured. The FDA will not approve the NDA or BLA unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications.
Use of pemvidutide for treating MASH or MASLD (referred to as NASH or NAFLD in the patent and patent applications) is further covered by, and subject to the Mederis IP License Agreement, with a granted patent in the United States, and pending applications in the United States, Europe, Japan and other commercially relevant jurisdictions.
Use of pemvidutide for treating MASH or MASLD (referred to as NASH or NAFLD in the patent and patent applications) is further covered by, and subject to the Mederis IP License Agreement, with granted patents in the United States, Europe, Japan and Korea and pending applications in the United States, Europe, Japan and other commercially relevant jurisdictions.
To date, we have obtained materials for clinical trials and non-clinical studies from third-party manufacturers who are suppliers to us. We intend to identify and qualify 32 Table of Contents additional contract manufacturers to provide commercial scale manufacturing prior to submission of an NDA or BLA to the FDA.
To date, we have obtained materials for clinical trials and non-clinical studies from third-party manufacturers who are suppliers to us. We intend to identify and qualify additional contract manufacturers to provide commercial scale manufacturing prior to submission of an NDA or BLA to the FDA.
The sponsor must submit an IND safety report within 15 calendar days after the sponsor determines that the information qualifies for reporting. The sponsor also must notify the FDA of any unexpected fatal or life-threatening suspected adverse reaction within 7 calendar days after the sponsor’s initial receipt of the information.
The sponsor must submit an IND safety report within 15 calendar days after the sponsor determines that the information qualifies for reporting. The sponsor also must notify the FDA of any unexpected fatal or life-threatening suspected adverse reaction within 7 16 Table of Contents calendar days after the sponsor’s initial receipt of the information.
Part I is assessed by a coordinated review by the competent authorities of all EU Member States in which an application for authorization of a clinical trial has been submitted (Member States concerned) of a draft report prepared by a Reference Member State. Part 27 Table of Contents II is assessed separately by each Member State concerned.
Part I is assessed by a coordinated review by the competent authorities of all EU Member States in which an application for authorization of a clinical trial has been submitted (Member States concerned) of a draft report prepared by a Reference Member State. Part II is assessed separately by each Member State concerned.
In the case of some products for severe or life-threatening diseases, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients. 17 Table of Contents ● Phase 2 .
In the case of some products for severe or life-threatening diseases, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients. ● Phase 2 .
The centralized procedure is optional for products containing a new active substance not yet authorized in the EU, or for products that constitute a significant therapeutic, scientific or 29 Table of Contents technical innovation or which are in the interest of public health in the EU.
The centralized procedure is optional for products containing a new active substance not yet authorized in the EU, or for products that constitute a significant therapeutic, scientific or technical innovation or which are in the interest of public health in the EU.
In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. Even after the IND has gone into effect and clinical testing has begun, the FDA may impose a partial or complete clinical hold on clinical trials due to safety concerns or non-compliance.
In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. Even after the IND has gone into effect and clinical testing has begun, the FDA 15 Table of Contents may impose a partial or complete clinical hold on clinical trials due to safety concerns or non-compliance.
The guidance therefore identifies the most typical kind of study for each phase. Phase 1 usually involves the initial introduction of the investigational product into human subjects, and studies in this phase usually have non-therapeutic objectives.
The guidance therefore identifies the most typical kind of study for each phase. 27 Table of Contents Phase 1 usually involves the initial introduction of the investigational product into human subjects, and studies in this phase usually have non-therapeutic objectives.
The Regulation is directly applicable in all EU Member States (and so does not require national implementing legislation in each EU Member State) and aims at simplifying and streamlining the approval of clinical studies in the EU.
The Regulation is directly applicable in all EU Member States (and so does not require national implementing legislation in each EU Member State) and aims at simplifying and streamlining the approval of clinical 26 Table of Contents studies in the EU.
There are two types of marketing authorizations: ● The centralized marketing authorization, which is issued by the European Commission through the centralized procedure, based on the opinion of the CHMP and which is valid throughout the entire territory of the EEA.
There are two types of marketing authorizations: ● The centralized marketing authorization, which is issued by the European Commission through the centralized procedure, based on the opinion of the CHMP and which is valid throughout the entire territory 28 Table of Contents of the EEA.
This data exclusivity if granted, prevents generic or biosimilar applicants from referencing the innovator’s pre-clinical and clinical trial data contained in the dossier of the reference product when applying for a generic or biosimilar marketing authorization, for a period of eight years from the date on which the reference product was first authorized in the EU.
This data exclusivity prevents generic applicants from referencing the innovator’s pre-clinical and clinical trial data contained in the dossier of the reference product when applying for a generic marketing authorization, for a period of eight years from the date on which the reference product was first authorized in the EU.
Our ability to successfully commercialize our product candidates will depend in part on the extent to which coverage and adequate reimbursement for these products and related treatments will be available from government health administration authorities, private health insurers and other organizations.
Our ability to successfully commercialize our product candidates will depend in part on the extent to which coverage and adequate 25 Table of Contents reimbursement for these products and related treatments will be available from government health administration authorities, private health insurers and other organizations.
The claims are directed to the use of pemvidutide in methods for reducing the risk of cardiovascular 15 Table of Contents (CV) disease in a human with or without also having Type 2 diabetes.
The claims are directed to the use of pemvidutide in methods for reducing the risk of cardiovascular (CV) disease in a human with or without also having Type 2 diabetes.
Moreover, they should comply with the ethical principles outlined in the Declaration of Helsinki. The applicant must submit a statement declaring such compliance as part of the marketing authorization.
Moreover, they should comply with the ethical principles outlined in the Declaration of Helsinki. The 31 Table of Contents applicant must submit a statement declaring such compliance as part of the marketing authorization.
Under the above described procedures, before granting the marketing authorization, the EMA or the competent authorities of the member states of the EEA make an assessment of the risk-benefit balance of the drug on the basis of scientific criteria concerning its quality, safety and efficacy.
Under the procedures described above, before granting a marketing authorization, the EMA (through the CHMP) or the competent authorities of the member states of the EEA make an assessment of the risk-benefit balance of the medicinal product on the basis of scientific criteria concerning its quality, safety and efficacy.
A single UK-wide marketing authorization will be granted by the MHRA for all novel medicinal products to be sold in the UK, enabling products to be sold in a single pack and under a single authorization throughout the UK.
A single UK-wide MA will be granted by the MHRA for medicinal products to be sold in the UK, enabling products to be sold in a single pack and under a single authorization throughout the UK.
After such eight year period, a generic or biosimilar marketing authorization can be submitted, and the innovator’s data may be referenced, but no generic or biosimilar product can be 30 Table of Contents marketed for a further two years.
After such eight year period, a generic marketing authorization can be submitted, and the innovator’s data may be referenced, but no generic product can be marketed for a further two years.
Large and established companies such as Eli Lilly, Roche,, Novo Nordisk, Pfizer, AstraZeneca, Amgen, Boehringer Ingelheim and Merck, among others, compete in the same market as our product candidates.
Large and established companies such as Eli Lilly, Roche, Novo Nordisk, Pfizer, AstraZeneca, Amgen, Boehringer Ingelheim and Merck, among others, compete in the same general therapeutic areas as our product programs.
Use of pemvidutide in methods for inducing weight loss is further covered in pending applications in the United States, Europe, Japan and Korea, as well as other commercially relevant jurisdictions owned by us and not subject to the Mederis IP License Agreement. The claims are directed to the use of pemvidutide in a therapeutic dosing regimen for chronic weight management.
Use of pemvidutide in methods for inducing weight loss is further covered in a granted patent in the United States and pending applications in the United States, Europe, Japan and Korea, as well as other commercially relevant jurisdictions owned by us and not subject to the Mederis IP License Agreement.
The patents and, if issued, the patent(s) resulting from the pending application(s) have an expiration date of no earlier than May 2032 and extending to May 2035, not giving effect to any potential extensions and assuming payment of all associated fees.
The patents and, if issued, the patent(s) resulting from the pending application(s) have an expiration date of no earlier than May 2032 and extending to May 2035, with additional patents and patent applications which expire no earlier than 2041 should they be granted, not giving effect to any potential extensions and assuming payment of all associated fees.
Many states have enacted similar laws, some of which apply regardless of payer. 22 Table of Contents The Federal civil False Claims Act (“FCA”) prohibits any person from, among other things, knowingly presenting or causing to be presented a false or fraudulent claim for payment of government funds, or knowingly making, using, or causing to be made or used, a false record or statement material to a false or fraudulent claim to the federal government, or knowingly concealing or knowingly and improperly avoiding, decreasing, or concealing an obligation to pay or transmit money or property to the government.
The Federal civil False Claims Act (“FCA”) prohibits any person from, among other things, knowingly presenting or causing to be presented a false or fraudulent claim for payment of government funds, or knowingly making, using, or causing to be made or used, a false record or statement material to a false or fraudulent claim to the federal government, or knowingly concealing or knowingly and improperly avoiding, decreasing, or concealing an obligation to pay or transmit money or property to the government.
Specifically, Phase 1 studies typically investigate initial safety and tolerability, PK, PD and/or drug activity, to preliminarily determine the potential therapeutic benefit of a medicine. Phase 1 studies may be conducted in healthy volunteers or certain types of patients.
Specifically, Phase 1 studies typically investigate initial safety and tolerability, PK, PD and/or drug activity, to preliminarily determine the potential therapeutic benefit of a medicine. Phase 1 studies may be conducted in healthy volunteers or certain types of patients. If the medicine has significant potential toxicity (e.g., cytotoxic products), the trial will usually be conducted in patients.
Other special rules apply certain types of biological medicines. For example, for plasma-derived medicinal products, the applicant must provide an information dossier, the Plasma Master File. MAAs for vaccines other than for influenza need to contain a Vaccine Antigen Master File. Special rules also apply to advanced therapy medicinal products, including gene therapies, somatic cell therapies and tissue-engineered products.
Other special rules apply to certain types of biological medicines. For example, for plasma-derived medicinal products, the applicant must provide an information dossier, the Plasma Master File. MAAs for vaccines other than for influenza need to contain a Vaccine Antigen Master File.
We also expect to pursue additional indications for pemvidutide that leverage the differentiated clinical profile of pemvidutide. Except where the context indicates otherwise, references to “we,” “us,” “our,” “Altimmune”, or the “Company” refer to the company and its subsidiaries.
We may also pursue additional indications for pemvidutide that leverage its differentiated clinical profile. Except where the context indicates otherwise, references to “we,” “us,” “our,” “Altimmune”, or the “Company” refer to the company and its subsidiaries. Pemvidutide We obtained pemvidutide as part of the acquisition Spitfire Pharma Inc., in July of 2019.
Employees and Human Capital Management As of December 31, 2024, we had 59 full-time employees, 19 of whom hold M.D. or Ph.D. degrees and 40 of whom hold other advanced degrees. Of our total workforce, 39 are engaged primarily in research and development activities and 20 are engaged primarily in executive, finance and accounting, and administrative functions.
Employees and Human Capital Management As of December 31, 2025, we had 57 full-time employees, 16 of whom hold M.D. or Ph.D. degrees and 23 of whom hold other advanced degrees. Of our total workforce, the majority are engaged primarily in research and development, and the remainder are engaged primarily in executive, finance and accounting, and administrative functions.
Post-approval modifications to a drug product, such as changes in indications, labeling or manufacturing processes or facilities, may require development and submission of additional information or data in a new or supplemental NDA or BLA, which would also require prior FDA approval.
Post-approval modifications to a drug product, such as changes in indications, labeling or manufacturing processes or facilities, may require development and submission of additional information or data in a new or supplemental NDA or BLA, which would also require prior FDA approval. 19 Table of Contents Post-Approval Requirements After regulatory approval of a product is obtained, products are subject to extensive continuing regulation and post-approval requirements.
Corporate Culture Our values – compliance, collaboration, integrity and high performance – are built on the foundation that the employees we hire and the way we treat one another promote creativity, innovation and productivity, which spur our success.
Corporate Culture Our values – commitment, communicate, collaborate, competence and courage – are built on the foundation that the employees we hire, and the way we treat one another, promote creativity, innovation and productivity, which spur our success.
Data and Market Exclusivity in the European Union In the EU, new chemical entities (including both small molecules and biological medicinal products), sometimes referred to as new active substances, qualify for eight years of data exclusivity upon marketing authorization and an additional two years of market exclusivity.
Special rules also apply to advanced therapy medicinal products, including gene therapies, somatic cell therapies and tissue-engineered products. 29 Table of Contents Data and Market Exclusivity in the European Union In the EU, new chemical entities (including both small molecules and biological medicinal products), sometimes referred to as new active substances, qualify for eight years of data exclusivity upon marketing authorization and an additional two years of market exclusivity.
We make available our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, and amendments to these reports, free of charge through our website (www.altimmune.com) as soon as reasonably practicable after we electronically file such material with, or furnish such material to, the SEC.
The information on, or that can be accessed through, our website is not part of this Annual Report and is not incorporated by reference herein. 32 Table of Contents We make available our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, and amendments to these reports, free of charge through our website (www.altimmune.com) as soon as reasonably practicable after we electronically file such material with, or furnish such material to, the SEC.
If the medicine has significant potential toxicity (e.g., cytotoxic products), the trial will usually be conducted in patients. 28 Table of Contents The most typical Phase 2 study is a therapeutic exploratory study that explores efficacy in narrowly defined, relatively homogenous groups of patients. Initially, studies may use a variety of designs (e.g., concurrent controls and comparisons with baseline status).
The most typical Phase 2 study is a therapeutic exploratory study that explores efficacy in narrowly defined, relatively homogenous groups of patients. Initially, studies may use a variety of designs (e.g., concurrent controls and comparisons with baseline status).
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 Nordisk and Boston Pharmaceuticals, 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, Eli Lilly, which is developing a GLP-1/GIP dual agonist, Inventiva, which is developing a pan-peroxisome proliferator-activated receptor (“PPAR”) agonist; Sagimet which is developing a fatty acid synthetase inhibitor, HEC Pharma which is developing a GLP-1/FGF-21dual agonist; and Pfizer and Eli Lilly, which are developing small molecule GLP-1 agonists.
We face competition for pemvidutide, our glucagon/GLP-1 dual agonist for the treatment of MASH from companies such as Madrigal Pharmaceuticals, Aligos and Viking Therapeutics, which are developing orally administered, thyroid hormone receptor (“THR”) β-selective agonists; Novo Nordisk, Roche, and 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; Eli Lilly, which is developing a glucose-dependent insulinotropic polypeptide receptor (“GIP”)/GLP-1 dual agonist and a GLP-1 GIP/glucagon triple agonist; Roche which is developing a GLP-1/GIP dual 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-21 dual agonist; and Pfizer, Roche, Gilead, AstraZeneca, and Eli Lilly, which are developing 11 Table of Contents small molecule GLP-1 agonists.
Under the Prescription Drug User Fee Act (“PDUFA”), as amended, each NDA or BLA must be accompanied by a significant application fee. PDUFA also imposes an annual prescription drug product program fee for biologics. Fee waivers or reductions are available in certain circumstances, including a waiver of the application fee for the first application filed by a small business.
Under the Prescription Drug User Fee Act (“PDUFA”), as amended, each NDA or BLA must be accompanied by a significant application fee. PDUFA also imposes an annual prescription drug product program fee for biologics.
Use of pemvidutide in methods for reducing the risk of cardiovascular (CV) disease is further covered in a United States patent application and corresponding international (PCT) patent application owned by us and not subject to the Mederis IP License Agreement, and from which we expect to file National Phase patent applications in commercially relevant jurisdictions.
Use of pemvidutide in methods for treating AUD is further covered in a pending provisional patent application in the United States, owned by us and not subject to the Mederis IP License Agreement, and from which we expect to file a non-provisional application in the United States and a corresponding international (PCT) patent application.
Use of pemvidutide in methods for reducing body weight in a human with fatty liver disease is further covered in United States patent application and corresponding international (PCT) patent application owned by us and not subject to the Mederis IP License Agreement, and from which we expect to file National Phase patent applications in commercially relevant jurisdictions.
Use of pemvidutide in methods for reducing body weight in a human with fatty liver disease is further covered in pending patent applications in the United States, Europe, Japan and Korea, as well as other commercially relevant jurisdictions, which are owned by us and not subject to the Mederis IP License Agreement.
Post-Approval Requirements After regulatory approval of a product is obtained, products are subject to extensive continuing regulation and post-approval requirements. For example, as a condition of approval of an NDA or BLA, the FDA may require post-marketing testing and surveillance to monitor the product’s safety or efficacy.
For example, as a condition of approval of an NDA or BLA, the FDA may require post-marketing testing and surveillance to monitor the product’s safety or efficacy.
Patent Rights Related to our Product Candidates Pemvidutide, Dual GLP-1/Glucagon Dual Agonist for Obesity and MASH We are the exclusive licensee of patent rights owned by Mederis to develop and commercialize surfactant functionalized (GLP-1-glucagon)/oxyntomodulin-based peptide therapeutics, and variants thereof, including pemvidutide, for any use including the treatment of obesity, metabolic syndrome, insulin resistance, diabetes and cardiovascular disease.
The patents and, if issued, the patent(s) resulting from the pending application(s) have an expiration date of no earlier than May 2035. 12 Table of Contents Patent Rights Related to our Product Candidates Pemvidutide, Dual GLP-1/Glucagon Dual Agonist for MASH, AUD and ALD We are the exclusive licensee of patent rights owned by Mederis to develop and commercialize surfactant functionalized (GLP-1-glucagon)/oxyntomodulin-based peptide therapeutics, and variants thereof, including pemvidutide, for any use including the treatment of metabolic syndrome, insulin resistance, diabetes and cardiovascular disease.
If issued, the patent(s) resulting from the pending application(s) have an expiration date of no earlier than December 2041, not giving effect to any potential extensions and assuming payment of all associated fees.
The claims are directed to the use of pemvidutide for reducing body weight and in a therapeutic dosing regimen for chronic weight management. If issued, the patent(s) resulting from the pending application(s) have an expiration date of no earlier than December 2041, not giving effect to any potential extensions and assuming payment of all associated fees.
As of December 31, 2024, 57 employees are located in the United States and 2 employees in the United Kingdom. Of our employees, 49% are female and 51% are male. None of our employees are represented by labor unions or covered by collective bargaining agreements.
As of December 31, 2025, 56 employees are located in the United States and 1 employee is located in the United Kingdom. None of our employees are represented by labor unions or covered by collective bargaining agreements.
Following submission of the application, the FDA reviews the NDA or BLA to determine if it is substantially complete before the agency accepts it for filing. The FDA may refuse to file any NDA or BLA that it deems incomplete or not properly reviewable at the time of submission and may request additional information.
The FDA may refuse to file any NDA or BLA that it deems incomplete or not properly reviewable at the time of submission and may request additional information. In this event, the NDA or BLA must be resubmitted with the additional information. The resubmitted application also is subject to review before the FDA accepts it for filing.
Item 1. Business Overview Altimmune, Inc. is a clinical stage biopharmaceutical company focused on developing treatments for obesity, metabolic and liver diseases. Our lead product candidate, pemvidutide (formerly known as ALT-801), is a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist. Pemvidutide is currently in clinical development for obesity and metabolic associated steatohepatitis (“MASH”).
Item 1. Business Overview Altimmune, Inc. is a late clinical-stage biopharmaceutical company developing novel therapies for serious liver diseases. Our lead product candidate, pemvidutide (formerly known as ALT-801), is a balanced 1:1 glucagon/GLP-1 dual receptor agonist in development for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), alcohol use disorder (“AUD”) and alcohol-associated liver disease (“ALD”).
Additionally, products approved under an NDA or BLA may qualify for the restoration of a portion of the patent term lost during product development and FDA review of the application, if approval of the application is the first permitted 21 Table of Contents commercial marketing of a drug containing the active ingredient.
This three-year exclusivity covers only the conditions of use associated with the new clinical investigations and does not prohibit the FDA from approving ANDAs for drugs containing the active ingredient for other conditions of use. 20 Table of Contents Additionally, products approved under an NDA or BLA may qualify for the restoration of a portion of the patent term lost during product development and FDA review of the application, if approval of the application is the first permitted commercial marketing of a drug containing the active ingredient.
The IRA provides a five-year temporary increase in Medicare Part B payment for certain qualifying biosimilars, and it 25 Table of Contents also delays the rebate rule that would require pass through of pharmacy benefit manager rebates to beneficiaries. The effect of IRA on our business and the healthcare industry in general is not yet known.
The IRA delays the rebate rule that would require pass through of pharmacy benefit manager rebates to beneficiaries. The effect of IRA on our business and the healthcare industry in general is not yet known.
These expedited programs include fast track designation, breakthrough therapy designation, priority review and accelerated approval. Each of these programs has its own features and qualifying criteria. A sponsor must submit a request for fast track designation, breakthrough therapy designation, or priority review, which may or may not be granted by the FDA.
These expedited programs include fast track designation, breakthrough therapy designation, priority review and accelerated approval. Each of these programs has its own features and qualifying criteria.
For fast track and breakthrough therapy designations, FDA may later decide the product no longer meets the conditions for designation and may rescind the designation.
A sponsor must submit a request for fast track designation, breakthrough therapy designation, or priority review, which may or may not be granted by the FDA. For fast track and breakthrough therapy designations, FDA may later decide the product no longer meets the conditions for designation and may rescind the designation.
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.
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.
In addition, the FDA may limit the indications for use or place other conditions on any approvals that could restrict the commercial application of the products. After approval, some types of changes to the approved product, such as adding new indications, manufacturing changes and additional labeling claims, are subject to further testing requirements and FDA review and approval.
After approval, some types of changes to the approved product, such as adding new indications, manufacturing changes and additional labeling claims, are subject to further testing requirements and FDA review and approval.
We cannot predict the reform initiatives that may be adopted in the future or whether initiatives that have been adopted will be repealed or modified.
Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payers. We cannot predict the reform initiatives that may be adopted in the future or whether initiatives that have been adopted will be repealed or modified.
Should any of our products be approved for sale, but then determined to be less cost effective than alternative therapies, the levels of reimbursement for these products, or the willingness to reimburse at all, could be impacted, which could materially impact our financial results.
Should any of our products be approved for sale, but then determined to be less cost effective than alternative therapies, the levels of reimbursement for these products, or the willingness to reimburse at all, could be impacted, which could materially impact our financial results. 23 Table of Contents Certain provisions of the Health Care Reform Law have been subject to judicial challenges, as well as efforts to repeal, replace or otherwise modify them or to alter their interpretation or implementation.
The biopsy-driven trial enrolled 212 subjects with and without diabetes randomized 1:2:2 to receive 1.2 mg, 1.8 mg pemvidutide or placebo weekly for 48 weeks.
The Phase 2b trial enrolled 212 subjects with biopsy-confirmed MASH and fibrosis stages F2/F3 with and without diabetes randomized 1:2:2 to receive weekly subcutaneous doses of pemvidutide at 1.2 mg, 1.8 mg or placebo.
FDA performance goals generally provide for action on an NDA or BLA within 10 months of the 60-day filing date, which would be within 12 months of its submission. That deadline can be extended under certain circumstances, including by the FDA’s requests for additional information.
Once the submission is accepted for filing, the FDA begins an in-depth substantive review of the NDA or BLA. FDA performance goals generally provide for action on an NDA or BLA within 10 months of the 60-day filing date, which would be within 12 months of its submission.
Our telephone number is (240) 654-1450, and our Internet website is www.altimmune.com and our investor relations website is located under the “Investors” tab. The information on, or that can be accessed through, our website is not part of this Annual Report and is not incorporated by reference herein.
Our telephone number is (240) 654-1450, and our Internet website is www.altimmune.com and our investor relations website is located under the “Investors” tab.
The EuPort domain comprises a hydrophobic domain (e.g., substituted or unsubstituted alkyl chain) and a hydrophilic group (e.g., saccharide) conjugated to a non-terminal amino acid of the peptide.
The EuPort domain comprises a hydrophobic domain (e.g., substituted or unsubstituted alkyl chain) and a hydrophilic group (e.g., saccharide) conjugated to a non-terminal amino acid of the peptide. Patents under Mederis IP License Agreement have been granted in the United States, Japan and Korea, and applications are pending in the United States, Japan as well as other commercially relevant jurisdictions.
This move provides our employees with continued flexibility to work in person, remotely or in a hybrid model. Available Information Our stock is traded on the Nasdaq Global Market (“NASDAQ”) under the symbol “ALT”. Our principal executive offices located at 910 Clopper Road, Suite 201S, Gaithersburg, Maryland 20878.
This approach allows us to maintain flexibility and retain the best talent for the roles that are the most critical to our strategy and success. Available Information Our stock is traded on the Nasdaq Global Market (“Nasdaq”) under the symbol “ALT”. Our principal executive offices located at 910 Clopper Road, Suite 201S, Gaithersburg, Maryland 20878.
In addition, the new arrangements require all medicines placed on the UK market to be labelled “UK only”, indicating they are not for sale in the EU.
In addition, the new arrangements require, for packs placed on the UK market on or after January 1, 2025, a "UK Only" label, indicating they are not for sale in the EU.
Some of these expedited programs could potentially apply to our product candidates, although this cannot be assured, and we do not currently have any products with expedited program designations. 18 Table of Contents The sponsor of a clinical trial or the sponsor’s designated responsible party may be required to register certain information about the trial and disclose certain results on government or independent registry websites, such as ClinicalTrials.gov.
The sponsor of a clinical trial or the sponsor’s designated responsible party may be required to register certain information about the trial and disclose certain results on government websites, such as ClinicalTrials.gov.
Additional legislative changes, regulatory changes or guidance could be adopted, which may impact the marketing approvals and reimbursement for our product candidates. Further, there has been increasing legislative, regulatory and enforcement interest in the United States with respect to drug pricing practices.
Although it is voluntary, the GENEROUS Model could also impact the drug pricing landscape for manufacturers. Further, there has been increasing legislative, regulatory and enforcement interest in the United States with respect to drug pricing practices.
In particular, the MHRA is now responsible for approving all medicinal products destined for the UK market (i.e., Great Britain and Northern Ireland), and the EMA no longer has any role in approving medicinal products destined for Northern Ireland under the EU centralized procedure.
In particular, the MHRA is responsible for approving medicinal products placed on the UK market, and the EMA no longer has a role in granting UK marketing authorizations.
However, although a separate authorization is now required to market medicinal products in the UK, under an international recognition procedure which was put in place by the MHRA on January 1, 2024, the MHRA may take into account decisions on the approval of a marketing authorization from the EMA (and certain other regulators) when considering an application for a UK marketing authorization.
However, although a separate authorization is required to market medicinal products in the UK, since January 1, 2024, the MHRA may rely on the International Recognition Procedure, or IRP, when reviewing certain types of MAAs.
For example, Executive Order 14117 of February 28, 2024, on Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern as implemented by Department of Justice regulations issued in December 2024, prohibits data brokerage transactions involving certain sensitive personal data categories, including health data, genetic data, and biospecimens, to countries of concern, including China.
For example, the Department of Justice’s January 8, 2025, rule on “Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons,” prohibits data brokerage transactions involving certain sensitive personal data categories, including health data, genetic data, and biospecimens, to countries of concern, including China.
Health Care Reform Law Our financial prospects could be affected by changes in health care spending and policy in the United States and abroad.
Any associated claims, inquiries, or investigations or other actions under these laws could lead to significant penalties or fines, monetary judgments or settlements including criminal and civil liability. U.S. Health Care Reform Law Our financial prospects could be affected by changes in health care spending and policy in the United States and abroad.
Pemvidutide Pemvidutide is a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist currently in clinical development for the treatment of obesity and MASH. Activation of the GLP-1 and glucagon receptors is believed to mimic the complementary effects of diet and exercise on weight loss, with GLP-1 suppressing appetite and glucagon increasing energy expenditure.
Pemvidutide is a novel, investigational peptide with balanced 1:1 glucagon/GLP-1 dual receptor agonist activity in clinical development for the treatment of MASH, AUD and ALD. We believe pemvidutide is the only glucagon/GLP-1 dual receptor agonist with a balanced 1:1 potency at glucagon and the GLP-1 receptors, in effect placing glucagon activity on an even footing with GLP-1 activity.
Patents under Mederis 14 Table of Contents IP License Agreement have been granted in the United States, Japan and Korea, and applications are pending in the United States, Japan as well as other commercially relevant jurisdictions.
Use of pemvidutide in methods for reducing the risk of cardiovascular (CV) disease is further covered in pending patent applications in the United States Europe, Japan and Korea, as well as other commercially relevant jurisdictions, which are owned by us and not subject to the Mederis IP License Agreement.
In addition, many other small companies are developing other new technologies directed towards obesity or MASH. Intellectual Property We generally seek patent protection for our technology and product candidates in the United States and abroad. The patent coverage available to biotechnology companies is generally uncertain because it involves complex legal and factual considerations.
The patent coverage available to biotechnology companies is generally uncertain because it involves complex legal and factual considerations.
Hybrid Culture In the second quarter of 2020, we made the decision to move to a hybrid workplace model, which means that certain of our employees have the option to be 100% remote, work full-time in our office, or have the flexibility to work between office and remotely.
Hybrid Culture Currently we have a hybrid workplace, which means that we evaluate and determine the optimal work arrangements for our employees on an individual basis including full-time in office, part-time in office or remote depending on our needs and the responsibilities of each employee.
As a result of the Northern Ireland protocol, following Brexit, the EMA remained responsible for approving novel medicines for supply in Northern Ireland under the EU centralized procedure, and a separate authorization was required to supply the same medicine in Great Britain (England, Wales and Scotland).
As a result of the Northern Ireland Protocol, different rules applied in Northern Ireland than in England, Wales, and Scotland (together, "Great Britain", or GB) for a period following Brexit, with Northern Ireland continuing to follow certain aspects of the EU regulatory regime.
Outside of the U.S., the legislative and regulatory landscape for privacy and data security continues to become more comprehensive. There has been increased attention to privacy and data security issues that could potentially affect our business, including as a result of the General Data Protection Regulation in the EU and the U.K. and data protection laws in the U.K.
Outside of the U.S., the legislative and regulatory landscape for privacy and data security is just as complex. The General Data Protection Regulation in the EU and the U.K. and data protection laws in the U.K, for example, impose potentially significant fines, and laws and regulations enacted in Asia and Latin America increase potential enforcement and litigation activity.
Accumulating clinical evidence suggests that reduction in liver fat is associated with resolution of liver inflammation and improvement in liver fibrosis, and that the magnitude of liver fat reduction is proportional to the improvement in these indices.
Accumulating clinical evidence suggests that reduction in liver fat and liver inflammation is associated with MASH resolution and improvement in liver fibrosis. Furthermore, considering 80-90% of individuals with MASH are also overweight, we believe that combining a direct liver acting mechanism with weight loss could provide a compelling treatment for MASH patients.
As 80-90% of individuals with MASH also have overweight or obesity we believe that combining a reduction in liver fat content with weight loss could be a compelling solution for treating MASH. The U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation to pemvidutide for the treatment of MASH.
In recognition of pemvidutide’s potential differentiating benefits, the U.S. Food and Drug Administration (“FDA”) has granted both Breakthrough Therapy Designation and Fast Track designation to pemvidutide for the treatment of MASH.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeMarket acceptance of any approved products depends on a number of other factors, including: ● the efficacy and safety of the product, as demonstrated in clinical trials; ● the clinical indications for which the product is approved and the label approved by regulatory authorities for use with the product, including any warnings that may be required on the label; 56 Table of Contents ● acceptance by physicians and patients of the product as a safe and effective treatment and the willingness of the target patient population to try new vaccines and/or therapies and of physicians to prescribe new vaccines and/or therapies; ● the cost, safety and efficacy of treatment in relation to alternative treatments; ● the availability of adequate course and reimbursement by third-party payers and government authorities; ● relative convenience and ease of administration; ● the prevalence and severity of adverse side effects; ● the effectiveness of our sales and marketing efforts; and ● the restrictions on the use of our products together with other medications, if any.
Biggest changeMarket acceptance of any approved products depends on a number of other factors, including: ● the efficacy and safety of the product, as demonstrated in clinical trials; ● the clinical indications for which the product is approved and the label approved by regulatory authorities for use with the product, including any warnings that may be required on the label; ● acceptance by physicians and patients of the product as a safe and effective treatment and the willingness of the target patient population to try new therapies and of physicians to prescribe new therapies; ● the cost, safety and efficacy of treatment in relation to alternative treatments, including generic products; ● the ability to obtain sufficient third-party coverage and adequate reimbursement, including with respect to the use of the approved product as a combination therapy; ● relative convenience and ease of administration; ● the prevalence and severity of adverse side effects, including the tolerability and effect on comorbidities relative to alternative treatments; 55 Table of Contents ● the effectiveness of our sales and marketing efforts and distribution support; ● any distribution and use restrictions imposed by the FDA or other regulatory authorities outside the United States or that are part of a REMS or voluntary risk management plan; and ● the restrictions on the use of our products together with other medications, if any.
Success in preclinical studies may not be predictive of similar results in humans during 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.
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.
Our future capital requirements depend on many factors, including: ● the progress, results and costs of our clinical trials for our leading product candidates; ● the scope, progress, results and costs of preclinical development, laboratory testing and clinical trials for our other product candidates; ● the amount of funding that we receive from other non-dilutive funding sources; ● the number and development requirements of other product candidates that we pursue; ● the timing of, and the costs involved in, obtaining regulatory approvals for our product candidates if clinical trials are successful and the outcome of regulatory review of our product candidates; ● our ability to contract with third-party manufacturing facilities for adequate supply and to establish processes that meet regulatory requirements for commercialization; ● the cost and timing of future commercialization activities for our products, if any of our product candidates are approved for marketing, including product manufacturing, marketing, sales and distribution costs; ● the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval; ● our ability to establish and maintain strategic partnerships, licensing or other arrangements and the financial terms of such agreements; and ● the costs involved in preparing, filing and prosecuting patent applications, and maintaining, defending and enforcing our intellectual property rights, including litigation costs and the outcome of such litigation.
Our future capital requirements depend on many factors, including: ● the progress, results and costs of our clinical trials for our leading product candidate; ● the scope, progress, results and costs of preclinical development, laboratory testing and clinical trials for our other product candidates; ● the amount of funding that we receive from other non-dilutive funding sources; ● the number and development requirements of other product candidates that we pursue; ● the timing of, and the costs involved in, obtaining regulatory approvals for our product candidates if clinical trials are successful and the outcome of regulatory review of our product candidates; ● our ability to contract with third-party manufacturing facilities for adequate supply and to establish processes that meet regulatory requirements for commercialization; ● the cost and timing of future commercialization activities for our products, if any of our product candidates are approved for marketing, including product manufacturing, marketing, sales and distribution costs; ● the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval; ● our ability to establish and maintain strategic partnerships, licensing or other arrangements and the financial terms of such agreements; and ● the costs involved in preparing, filing and prosecuting patent applications, and maintaining, defending and enforcing our intellectual property rights, including litigation costs and the outcome of such litigation.
Violations of the FCA can result in treble damages, mandatory per claim penalties, and exclusion from participation in federal health care programs. ● HIPAA created additional federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payer (e.g., public or private) and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters.
Violations of the FCA can result in treble damages, mandatory per claim penalties, and exclusion from participation in federal health care programs. ● HIPAA, which created additional federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payer (e.g., public or private) and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters.
The market price for our common stock may be influenced by many factors, including: ● announcements relating to development, regulatory approvals or commercialization of our product candidates or those of competitors; ● results of clinical trials of our product candidates or those of our competitors; ● announcements by us or our competitors of significant strategic partnerships or collaborations or terminations of such arrangements; ● actual or anticipated variations in our operating results and whether we have achieved key business targets; ● sales of our common stock, including sales by our directors and officers or specific stockholders; ● changes in, or our failure to meet, financial estimates by us or by any securities analysts who might cover our stock; ● changes in securities analysts’ buy and/or sell recommendations; ● general economic, political, or stock market conditions; ● conditions or trends in our industry; ● changes in laws or other regulatory actions affecting us or our industry; ● stock market price and volume fluctuations of comparable companies and, in particular, those that operate in the biopharmaceutical industry; ● announcements of investigations or regulatory scrutiny of our operations or lawsuits filed against us; ● capital commitments; 72 Table of Contents ● investors’ general perception of our company, our business, and our prospects; ● disputes concerning our intellectual property or other proprietary rights; and ● recruitment or departure of key personnel.
The market price for our common stock may be influenced by many factors, including: ● announcements relating to development, regulatory approvals or commercialization of our product candidates or those of competitors; ● results of clinical trials of our product candidates or those of our competitors; ● announcements by us or our competitors of significant strategic partnerships or collaborations or terminations of such arrangements; ● actual or anticipated variations in our operating results and whether we have achieved key business targets; ● sales of our common stock, including sales by our directors and officers or specific stockholders; ● changes in, or our failure to meet, financial estimates by us or by any securities analysts who might cover our stock; ● changes in securities analysts’ buy and/or sell recommendations; 73 Table of Contents ● general economic, political, or stock market conditions; ● conditions or trends in our industry; ● changes in laws or other regulatory actions affecting us or our industry; ● stock market price and volume fluctuations of comparable companies and, in particular, those that operate in the biopharmaceutical industry; ● announcements of investigations or regulatory scrutiny of our operations or lawsuits filed against us; ● capital commitments; ● investors’ general perception of our company, our business, and our prospects; ● disputes concerning our intellectual property or other proprietary rights; and ● recruitment or departure of key personnel.
In the U.S., we may be subject to data privacy and security laws and regulations by both the federal government and the states in which we conduct our business, including, for example, state data breach notification laws, state health information and/or genetic privacy laws and federal and state consumer protection laws (including Section 5 of the FTC Act and the California Consumer Privacy Act (“CCPA”)), which govern the collection, use, disclosure, and protection of health-related and other personal information.
In the U.S., we may be subject to data privacy and security laws and regulations by both the federal government and the states in which we conduct our business, including, for example, state data breach notification laws, state health information and/or genetic privacy laws and federal and state consumer protection laws (including Section 5(a) of the FTC Act and the California Consumer Privacy Act (“CCPA”)), which govern the collection, use, disclosure, and protection of health-related and other personal information.
The Inflation Reduction Act of 2022 (IRA), for example, includes several provisions that may impact our business to varying degrees, including provisions that reduce the out-of-pocket spending cap for Medicare Part D beneficiaries from $7,050 to $2,000 starting in 2025, thereby eliminating the so-called coverage gap; impose new manufacturer financial liability on certain drugs under Medicare Part D; allow the U.S. government to negotiate Medicare Part B and Part D price caps for certain high-cost drugs and biologics without generic or biosimilar competition; require companies to pay rebates to Medicare for certain drug prices that increase faster than inflation; and delay until January 2032 the implementation of the HHS rebate rule that would have limited the fees that pharmacy benefit managers can charge.
The Inflation Reduction Act of 2022 (IRA), for example, includes several provisions that may impact our business to varying degrees, including provisions that reduce the out-of-pocket spending cap for Medicare Part D beneficiaries from $7,050 to $2,000 starting in 2025, thereby eliminating the so-called coverage gap; impose new manufacturer financial liability on certain drugs under Medicare Part D; allow the U.S. government to negotiate Medicare Part B and Part D price caps for certain high-cost drugs and biologics without generic competition; require companies to pay rebates to Medicare for certain drug prices that increase faster than inflation; and delay until January 2032 the implementation of the HHS rebate rule that would have limited the fees that pharmacy benefit managers can charge.
Risks Related to Our Business, Financing Requirements, Product Development and Clinical Trials We have incurred significant losses since our founding and anticipate that we will continue to incur significant losses for the foreseeable future and may never achieve or maintain profitability. We are a clinical-stage biotechnology company and have not yet generated revenues from product sales.
Risks Related to Our Business, Financing Requirements, Product Development and Clinical Trials We have incurred significant losses since our founding and anticipate that we will continue to incur significant losses for the foreseeable future and may never achieve or maintain profitability. We are a late clinical-stage biotechnology company and have not yet generated revenues from product sales.
We anticipate that our expenses will increase significantly if and as we: ● continue our clinical trials for our product candidates; ● initiate additional preclinical studies, clinical trials or other studies or trials for our other product candidates; ● manufacture material for clinical trials and, if any product candidate is approved for marketing, for commercial sale; 34 Table of Contents ● seek regulatory approvals for our product candidates that successfully complete clinical trials; ● establish a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain marketing approval; ● seek to discover and develop additional product candidates; ● acquire or in-license other product candidates and technologies; ● make royalty, milestone or other payments under any in-license agreements; ● form strategic partnerships and/or make additional acquisitions; ● maintain, protect and expand our intellectual property portfolio; ● attract and retain skilled personnel; and ● create additional infrastructure to support our operations as a public company and our product development and planned future commercialization efforts.
We anticipate that our expenses will increase significantly if and as we: ● continue our development work for our clinical programs; ● initiate additional preclinical studies, clinical trials or other studies or trials for our other product candidates; ● manufacture material for clinical trials and, if any product candidate is approved for marketing, for commercial sale; 34 Table of Contents ● seek regulatory approvals for our product candidates that successfully complete clinical trials; ● establish a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain marketing approval; ● seek to discover and develop additional product candidates; ● acquire or in-license other product candidates and technologies; ● make royalty, milestone or other payments under any in-license agreements; ● form strategic partnerships and/or make additional acquisitions; ● maintain, protect and expand our intellectual property portfolio; ● attract and retain skilled personnel; and ● create additional infrastructure to support our operations as a public company and our product development and planned future commercialization efforts.
Alternatively, it may be necessary for us to raise additional funds for these activities through public or private financings or through the issuance of debt. Additional funds may not be available on terms that are favorable to the Company, or at all, and any debt financing may involve covenants limiting or restricting our ability to take certain actions.
Alternatively, it may be necessary for us to raise additional funds for these activities through public or private financings or through the issuance of debt. Additional funds may not be available on terms that are favorable to us, or at all, and any debt financing may involve covenants limiting or restricting our ability to take certain actions.
Therefore, these patents and patent applications may not be prosecuted and enforced in a manner consistent with the best interests of the Company’s 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.
Therefore, these patents and patent applications may not be prosecuted and enforced in a manner consistent with the best interests of our 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.
Events that may prevent successful or timely completion of clinical development include: ● delays or failure in reaching a consensus with regulatory agencies on trial design; ● delays or failure in reaching agreement on acceptable terms with prospective contract research organizations (“CROs”) and clinical trial sites; ● delays or failure in obtaining required approvals from the IRB or other similar committees or bodies at each clinical trial site; ● imposition of a clinical hold by regulatory agencies for any reason, including safety concerns raised by other clinical trials of similar product candidates that may reflect an unacceptable risk with the patient population, technology platform, product stability or after an inspection of clinical operations or trial sites; ● failure to perform clinical trials in accordance with the FDA’s GCP or applicable regulatory guidelines in other relevant countries; ● delays or failure in the testing, validation, manufacturing and delivery of the product candidates to the clinical sites, including as a result of supply chain delays in obtaining materials for the manufacture of our clinical trial materials; ● the number of patients required for our clinical trials may be larger than we anticipate, enrollment in our clinical trials may be slower than we anticipate or participants may withdraw from our clinical trials, fail to complete dosing or fail to return for post-treatment follow-up at higher rates than we anticipate, any of which could result in significant delay; ● withdrawal of clinical trial sites from our clinical trials, including as a result of changing standards of care or the ineligibility of a site to participate; ● occurrence of serious adverse events in clinical trials that are associated with the product candidate that are viewed to outweigh its potential benefits; ● our preclinical tests or clinical trials may produce negative or inconclusive results, and we may decide, or regulators or funders may require us, to conduct additional preclinical testing or clinical trials or to abandon projects that we expected to be promising; ● our third-party contractors (such as CROs, product manufacturers, or investigators) may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner; ● fraudulent activity by a clinical researcher, if discovered, could preclude the submission of clinical data prepared by that researcher and/or lead to the suspension of substantive scientific review of one or more of our marketing applications by regulatory agencies; ● the cost of our clinical trials may be greater than we anticipate; ● additional trials may be necessary, including trials to analyze different dose strengths or dosing schemes; 39 Table of Contents ● the regulatory requirements for product approval may not be explicit, may evolve over time and may diverge by jurisdiction; ● evolution in the standard of care that require amendments to ongoing clinical trials and/or the conduct of additional preclinical studies or clinical trials; or ● changes in regulatory requirements and guidance that require amending or submitting new clinical protocols.
Events that may prevent successful or timely completion of clinical development include: ● delays or failure in reaching a consensus with regulatory agencies on trial design; ● delays or failure in reaching agreement on acceptable terms with prospective contract research organizations (“CROs”) and clinical trial sites, the terms of which may vary significantly among different CROs and clinical trial sites; ● delays or failure in obtaining required approvals from the IRB or other similar committees or bodies at each clinical trial site; ● imposition of a clinical hold by regulatory agencies for any reason, including safety concerns raised by other clinical trials of similar product candidates that may reflect an unacceptable risk with the patient population, technology platform, product stability, or after an inspection of clinical operations or trial sites; ● deviations from the trial protocol by clinical trial sites and investigators, or failure to perform clinical trials in accordance with the FDA’s GCP or applicable regulatory guidelines in other relevant countries; ● delays or failure in the testing, validation, manufacturing and delivery of the product candidates to the clinical sites, including as a result of supply chain delays in obtaining materials for the manufacture of our clinical trial materials; ● the number of patients required for our clinical trials may be larger than we anticipate, enrollment in our clinical trials may be slower than we anticipate or participants may withdraw from our clinical trials, fail to complete dosing or fail to return for post-treatment follow-up at higher rates than we anticipate, any of which could result in significant delay; ● delays in initiating clinical trial sites or withdrawal of clinical trial sites from our clinical trials, including as a result of changing standards of care or the ineligibility of a site to participate; ● occurrence of serious adverse events in clinical trials that are associated with the product candidate that are viewed to outweigh its potential benefits; 39 Table of Contents ● our preclinical tests or clinical trials may produce negative or inconclusive results, and we may decide, or regulators or funders may require us, to conduct additional preclinical testing or clinical trials or to abandon projects that we expected to be promising; ● our third-party contractors (such as CROs, product manufacturers, or investigators) may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner; ● fraudulent activity by a clinical researcher, if discovered, could preclude the submission of clinical data prepared by that researcher and/or lead to the suspension of substantive scientific review of one or more of our marketing applications by regulatory agencies; ● the cost of our clinical trials may be greater than we anticipate; ● additional trials may be necessary, including trials to analyze different dose strengths or dosing schemes; ● the regulatory requirements for product approval may not be explicit, may evolve over time and may diverge by jurisdiction; ● evolution in the standard of care that require amendments to ongoing clinical trials and/or the conduct of additional preclinical studies or clinical trials; or ● changes in regulatory requirements and guidance that require amending or submitting new clinical protocols.
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 the FDA or comparable foreign regulatory authorities approve generic 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.
We use hazardous chemicals and biological materials in certain aspects of our business and are subject to a variety of federal, state and local laws and regulations governing the use, generation, manufacture, distribution, storage, handling, treatment and disposal of these materials.
We may use hazardous chemicals and biological materials in certain aspects of our business and are subject to a variety of federal, state and local laws and regulations governing the use, generation, manufacture, distribution, storage, handling, treatment and disposal of these materials.
Risks Related to Commercialization of the Company’s Product Candidates Our future commercial success depends upon attaining significant market acceptance of our product candidates, if approved, among physicians, patients, third-party payers and others in the medical community.
Risks Related to Commercialization of our Product Candidates Our future commercial success depends upon attaining significant market acceptance of our product candidates, if approved, among physicians, patients, third-party payers and others in the medical community.
If there is any conflict, dispute, disagreement or issue of non-performance between the Company 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.
If there is any conflict, dispute, disagreement or issue of non-performance between us 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.
We may also arrive at different conclusions, or considerations may qualify such results, once we have received and fully evaluated additional data. Differences between preliminary or interim data and final data could adversely affect our business.
We may also arrive at different conclusions, or considerations may qualify such results, once we have received and fully evaluated additional data. Material differences between preliminary or interim data and final data could adversely affect our business.
These agreements require that all confidential information developed by the individual or made known to the individual by the Company during the course of the individual’s relationship with us be kept confidential and not disclosed to third parties.
These agreements require that all confidential information developed by the individual or made known to the individual by us during the course of the individual’s relationship with us be kept confidential and not disclosed to third parties.
Our current and anticipated future dependence upon others for the manufacture of our product candidates or products may adversely affect our future profit margins and our ability to commercialize any products that receive marketing approval on a timely and competitive basis. 58 Table of Contents If we are unable to manufacture our products in sufficient quantities, or at sufficient yields, or are unable to obtain regulatory approvals for a manufacturing facility for our products, we may experience delays in product development, clinical trials, regulatory approval and commercial distribution.
Our current and anticipated future dependence upon others for the manufacture of our product candidates or products may adversely affect our future profit margins and our ability to commercialize any products that receive marketing approval on a timely and competitive basis. 57 Table of Contents If we are unable to manufacture our product candidates in sufficient quantities, or at sufficient yields, or are unable to obtain regulatory approvals for a manufacturing facility for our product candidates, we may experience delays in product development, clinical trials, regulatory approval and commercial distribution.
We have no experience in filing and supporting the applications necessary to gain marketing approvals and expect to rely on third-party CROs or regulatory consultants to assist us in this process.
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.
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 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.
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.
Under current law, the remaining federal amount of $179.5 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.
Under current law, the remaining federal amount of $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.
Misconduct by these parties could include intentional, reckless and/or negligent conduct that fails to comply with the laws of the FDA and similar foreign regulatory bodies; fails to comply with manufacturing standards we have established, or with federal, state and foreign health care fraud and abuse laws and regulations; fails to report financial information or data accurately, including to our regulators, such as the FDA and similar foreign regulatory bodies; or fails to disclose unauthorized activities to the Company.
Misconduct by these parties could include intentional, reckless and/or negligent conduct that fails to comply with the laws of the FDA and similar foreign regulatory bodies; fails to comply with manufacturing standards we have established, or with federal, state and foreign health care fraud and abuse laws and regulations; fails to report financial information or data accurately, including to our regulators, such as the FDA and similar foreign regulatory bodies; or fails to disclose unauthorized activities to us.
A data security breach or compromise could lead to the loss of trade secrets or other intellectual property, the value of which may be contingent upon maintaining our confidentiality, or could lead to the public exposure of personal information (including sensitive personal medical information) of clinical trial participants, our employees and others, or adversely impact the conduct of scientific research and clinical trials, including the submission of research results to support marketing authorizations.
A data security breach or other incident could lead to the loss of trade secrets or other intellectual property, the value of which may be contingent upon maintaining our confidentiality, or could lead to the public exposure of personal information (including sensitive personal medical information) of clinical trial participants, our employees and others, or adversely impact the conduct of scientific research and clinical trials, including the submission of research results to support marketing authorizations.
To achieve commercial success for any product for which we obtain marketing approval, and for which we decide to independently commercialize, we will need to establish a sales and marketing organization. 59 Table of Contents In the future, we may build a focused sales and marketing infrastructure to market or co-promote some of our product candidates in the United States and in Europe, if and when they are approved.
To achieve commercial success for any product for which we obtain marketing approval, and for which we decide to independently commercialize, we will need to establish a sales and marketing organization. 58 Table of Contents In the future, we may build a focused sales and marketing infrastructure to market or co-promote some of our product candidates in the United States and in Europe, if and when they are approved.
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 may result in significant additional expense or could limit sales of the approved product.
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 expenses or could limit sales of the approved product.
As a result, we could face significant adverse consequences including: ● a limited availability of market quotations for our securities; ● a determination that our common stock is a “penny stock” which will require brokers trading in our common stock to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our securities; ● a limited amount of news and analyst coverage for us; and ● a decreased ability to issue additional securities (including pursuant to short-form registration statements on Form S-3) or obtain additional financing in the future.
As a result, we could face significant adverse consequences including: ● a limited availability of market quotations for our securities; ● a determination that our common stock is a “penny stock” which will require brokers trading in our common stock to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our securities; 74 Table of Contents ● a limited amount of news and analyst coverage for us; and ● a decreased ability to issue additional securities (including pursuant to short-form registration statements on Form S-3) or obtain additional financing in the future.
The timing of our clinical trials depends on the speed at which we can recruit subjects to participate in testing our product candidates.
The timing of our clinical trials depends on the speed at which we can recruit eligible subjects to participate in testing our product candidates.
Regardless of the merits or eventual outcome, liability claims may result in: ● decreased demand for any product candidates or products that we may develop; 61 Table of Contents ● injury to our reputation and significant negative media attention; ● withdrawal of clinical trial participants; ● significant costs to defend the related litigations; ● a diversion of management’s time and the Company’s resources; ● substantial monetary awards to trial participants or patients; ● product recalls, withdrawals or labeling, marketing or promotional restrictions; ● loss of revenue; ● the inability to commercialize any product candidates that we may develop; and ● a decline in our stock price.
Regardless of the merits or eventual outcome, liability claims may result in: ● decreased demand for any product candidates or products that we may develop; 60 Table of Contents ● injury to our reputation and significant negative media attention; ● withdrawal of clinical trial participants; ● significant costs to defend the related litigations; ● a diversion of management’s time and our resources; ● substantial monetary awards to trial participants or patients; ● product recalls, withdrawals or labeling, marketing or promotional restrictions; ● loss of revenue; ● the inability to commercialize any product candidates that we may develop; and ● a decline in our stock price.
Our product candidates could fail to receive regulatory approval from the FDA or comparable regulatory authorities outside the United States for several reasons, including: ● disagreement with the design or implementation of our clinical trials ; ● failure to demonstrate that our candidate is safe and effective for the proposed indication; ● failure of clinical trial results to meet the level of statistical significance required for approval; ● failure to demonstrate that the product candidate’s benefits outweigh its risks; ● disagreement with our interpretation of preclinical or clinical data; and ● inadequacies in the manufacturing facilities or processes of third-party manufacturers.
Our product candidates could fail to receive regulatory approval from the FDA or comparable regulatory authorities outside the United States for several reasons, including: ● disagreement with the design or implementation of our clinical trials ; 46 Table of Contents ● failure to demonstrate that our candidate is safe and effective for the proposed indication; ● failure of clinical trial results to meet the level of statistical significance required for approval; ● failure to demonstrate that the product candidate’s benefits outweigh its risks; ● disagreement with our interpretation of preclinical or clinical data; and ● inadequacies in the manufacturing facilities or processes of third-party manufacturers.
This could require us to expend significant efforts and resources or incur significant expense to eliminate these problems and address related security concerns. In addition, procedures and safeguards must continually evolve to meet new data security challenges, and enhancing protections, and conducting investigations and remediation, may impose additional costs on the Company.
This could require us to expend significant efforts and resources or incur significant expense to eliminate these problems and address related security concerns. In addition, procedures and safeguards must continually evolve to meet new data security challenges, and enhancing protections, and conducting investigations and remediation, may impose additional costs on us.
For example, the Budget Control Act of 2011, as amended by the American Taxpayer Relief Act of 2012, among other things, created measures for spending reductions by Congress that include aggregate reductions of Medicare payments to providers of on average 2% per fiscal year, which remain in effect through 2032.
For example, the Budget Control Act of 2011, as amended by the American Taxpayer Relief Act of 2012, among other things, created measures for spending reductions by Congress that include aggregate reductions of Medicare payments to providers of on average 2% per fiscal year, which remain in effect until 2032.
Our ability to successfully initiate, enroll and complete a clinical trial in any other foreign country is subject to numerous risks unique to conducting business in foreign countries, including: ● difficulty in establishing or managing relationships with CROs and physicians; ● different standards for the approval and conduct of clinical trials; ● our inability to locate qualified local consultants, physicians and partners; and 44 Table of Contents ● the potential burden of complying with a variety of foreign laws, medical standards and regulatory requirements, including the regulation of the conduct of clinical trials, pharmaceutical and biotechnology products and treatment.
Our ability to successfully initiate, enroll and complete a clinical trial in any other foreign country is subject to numerous risks unique to conducting business in foreign countries, including: ● difficulty in establishing or managing relationships with CROs and physicians; ● different standards for the approval and conduct of clinical trials; ● our inability to locate qualified local consultants, physicians and partners; and ● the potential burden of complying with a variety of foreign laws, medical standards and regulatory requirements, including the regulation of the conduct of clinical trials, pharmaceutical and biotechnology products and treatment.
Even if we are successful in our efforts to establish strategic partnerships, the terms that we agree upon may not be favorable to the Company, and we may not be able to maintain such strategic partnerships if, for example, development or approval of a product is delayed or sales of an approved product are disappointing.
Even if we are successful in our efforts to establish strategic partnerships, the terms that we agree upon may not be favorable to us, and we may not be able to maintain such strategic partnerships if, for example, development or approval of a product is delayed or sales of an approved product are disappointing.
Based on our current operating plan, we believe that our existing cash will be sufficient to fund our projected operating expenses and capital expenditure requirements for at least a twelve-month period from the issuance date of our December 31, 2024 financial statements.
Based on our current operating plan, we believe that our existing cash will be sufficient to fund our projected operating expenses and capital expenditure requirements for at least a twelve-month period from the issuance date of our December 31, 2025 financial statements.
In order for the Company to successfully partner our product candidates, potential partners must view these product candidates as economically valuable in markets they determine to be attractive in light of the terms that we are seeking and other products available for licensing from other companies.
In order for us to successfully partner our product candidates, potential partners must view these product candidates as economically valuable in markets they determine to be attractive in light of the terms that we are seeking and other products available for licensing from other companies.
If the FDA or other regulatory authority approves any of our product candidates, the manufacturing processes, 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.
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.
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, which introduces risks to our business model and potential limitations to any success we may achieve.
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 candidate programs, which introduces risks to our business model and potential limitations to any success we may achieve.
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’s business and financial condition.
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 our business and financial condition.
We have adopted a Code of Business Conduct and Ethics Policy and other policies and practices that are designed to help ensure that the Company, our employees, officers, agents, intermediaries and other third parties comply with applicable laws, but it is not always possible to identify and deter such misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations.
We have adopted a Code of Business Conduct and Ethics Policy and other policies and 72 Table of Contents practices that are designed to help ensure that we, our employees, officers, agents, intermediaries and other third parties comply with applicable laws, but it is not always possible to identify and deter such misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations.
The California Privacy Rights Act, or CPRA, significantly modified the CCPA and imposed additional obligations on covered businesses, including by expanding consumers’ rights with respect to their personal data and established a state agency vested with the authority to enforce the CCPA.
The California Privacy Rights Act, or CPRA, significantly modified the CCPA and imposed additional obligations on covered businesses, including by expanding consumers’ rights with respect to their personal data and establishing a state agency vested with the authority to enforce the CCPA.
Moreover, there are no safe harbors for many common practices, such as educational and research grants, charitable donations, product support and patient assistance programs. Violations of the Anti-Kickback Statute may be punished by civil and criminal penalties, damages, fines, or exclusion from participation in federal health care programs like Medicare and Medicaid.
Moreover, there are no safe harbors for many common practices, such as educational and research grants, charitable donations, 67 Table of Contents product support and patient assistance programs. Violations of the Anti-Kickback Statute may be punished by civil and criminal penalties, damages, fines, or exclusion from participation in federal health care programs like Medicare and Medicaid.
Significant write-downs of our long-lived assets in the future could adversely affect our balance sheet and results of operations. We will require substantial additional financing to achieve our goals, and a failure to obtain this necessary capital when needed would force us to delay, limit, reduce or terminate our product development or commercialization efforts.
Significant write-downs of our long-lived assets in the future could adversely affect our balance sheet and results of operations. 35 Table of Contents We will require substantial additional financing to achieve our goals, and a failure to obtain this necessary capital when needed would force us to delay, limit, reduce or terminate our product development or commercialization efforts.
Since our common stock began trading on a post-reverse stock split basis on September 14, 2018 and through December 31, 2024, our stock has traded in a range with a low of $1.51 and a high of $36.25.
Since our common stock began trading on a post-reverse stock split basis on September 14, 2018 and through December 31, 2025, our stock has traded in a range with a low of $1.51 and a high of $36.25.
Other consequences include the issuance of fines, 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.
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.
Companies that fail to accurately report this kind of pricing information to the U.S. government could be subject to fines and other sanctions (including potential FCA liability) that could adversely affect their business. We must comply with data privacy and security laws and regulations, and failure to comply with these laws and regulations could expose us to significant liabilities.
Companies that fail to accurately report this kind of pricing information to the U.S. government could be subject to fines and other sanctions (including potential FCA liability) that could adversely affect their business. 69 Table of Contents We must comply with data privacy and security laws and regulations, and failure to comply with these laws and regulations could expose us to significant liabilities.
We can give no assurances that we will ever pay dividends. Altimmune has never paid any dividends on our common stock. While subject to periodic review, our current policy is to retain all earnings, if any, primarily to finance our future growth or ability to consummate strategic transactions, such as a merger or other business combination.
We can give no assurances that we will ever pay dividends. We have never paid any dividends on our common stock. While subject to periodic review, our current policy is to retain all earnings, if any, primarily to finance our future growth or ability to consummate strategic transactions, such as a merger or other business combination.
Our operations and those of our business partners, such as CROs, vendors and others that manage sensitive data, are highly dependent on information technology systems, including Internet-based systems, which may be vulnerable to damage or interruption from, among other things, computer viruses, computer hackers, phishing attacks, ransomware, malware, social engineering, malicious code, employee theft, fraud, misconduct or misuse, denial-of-service attacks, sophisticated nation-state and nation-state-supported actors, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures, breakdown, wrongful intrusions, data breaches and malicious attack.
Our operations and those of our business partners, such as CROs, vendors and others that manage sensitive data, are highly dependent on information technology systems, including Internet-based systems, which may be vulnerable to damage or interruption from, among other things, malicious uses of artificial intelligence, computer viruses, computer hackers, phishing attacks, ransomware, malware, social engineering, malicious code, employee theft, fraud, misconduct or misuse, denial-of-service attacks, sophisticated nation-state and nation-state-supported actors, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures, breakdown, wrongful intrusions, data breaches, other incidents and malicious attacks.
Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. Third-party claims of intellectual property infringement or misappropriation may prevent or delay our development and commercialization efforts.
Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. 52 Table of Contents Third-party claims of intellectual property infringement or misappropriation may prevent or delay our development and commercialization efforts.
Any delay in entering into strategic partnership agreements related to 60 Table of Contents our product candidates could delay the development and commercialization of our product candidates and reduce their competitiveness even if they reach the market.
Any delay in entering into strategic partnership agreements related to our product 59 Table of Contents candidates could delay the development and commercialization of our product candidates and reduce their competitiveness even if they reach the market.
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 51 Table of Contents results of studies conducted in compliance with an approved PIP, it may be possible to obtain a six month extension of a supplementary protection certificate extending patent protection for a medicinal product.
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-month extension of a supplementary protection certificate extending patent protection for a medicinal product.
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, bankruptcy and similar events.
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, bankruptcy, regulatory action or similar events.
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 million and $88.4 million for the years ended December 31, 2024 and 2023, respectively.
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 $88.1 million and $95.1 million for the years ended December 31, 2025 and 2024, respectively.
Subject enrollment is affected by several factors, including: ● severity of the disease under investigation; ● design of the trial protocol; ● size of the patient population; ● eligibility criteria for the trial in question; 40 Table of Contents ● perceived risks and benefits of the product candidate being tested; ● willingness or availability of subjects to participate in our clinical trials; ● proximity and availability of clinical trial sites for prospective subjects; ● our ability to recruit clinical trial investigators with appropriate competencies and experience; ● availability of competing vaccines and/or therapies and related clinical trials; ● efforts to facilitate timely enrollment in clinical trials; ● our ability to obtain and maintain subject consents; ● patient referral practices of physicians; and ● ability to monitor subjects adequately during and after treatment.
Subject enrollment and retention is affected by several factors, including: ● severity of the disease under investigation; ● design of the trial protocol; ● size of the patient population; ● eligibility criteria for the trial in question; ● perceived risks and benefits of the product candidate being tested; ● willingness or availability of subjects to participate in our clinical trials; ● proximity and availability of clinical trial sites for prospective subjects; ● our ability to recruit clinical trial investigators with appropriate competencies and experience; ● availability of competing therapies and related clinical trials; ● efforts to facilitate timely enrollment in clinical trials; ● our ability to obtain and maintain subject consents; ● patient referral practices of physicians; and ● ability to monitor subjects adequately during and after treatment.
The net operating loss 46 Table of Contents 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.
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.
Later discovery of previously unknown problems with an approved product, including adverse events of unanticipated severity or frequency, or with manufacturing operations or processes, may result in, among other things: ● restrictions on the marketing or manufacturing of the product, withdrawal of the product from the market or voluntary or mandatory product recalls; ● fines or warning letters, or clinical holds on clinical trials involving related product candidates; ● refusal by the FDA or other regulatory authorities to approve pending applications or supplements to approved applications submitted by us or suspension or revocation of product license approvals; ● product seizure or detention or refusal to permit the import or export of products; and ● injunctions or the imposition of civil, criminal and/or administrative penalties, damages, monetary fines, disgorgement, exclusion from participation in governmental reimbursement programs, such as Medicare, Medicaid and other federal health care programs and curtailment or restructuring of our operations.
Later discovery of previously unknown problems with an approved product, including adverse events of unanticipated severity or frequency, or with manufacturing operations or processes, may result in, among other things: ● restrictions on the marketing or manufacturing of the product, withdrawal of the product from the market or voluntary or mandatory product recalls; ● fines, FDA Form 483s, warning letters, untitled letters or clinical holds on clinical trials involving related product candidates; ● refusal by the FDA or other regulatory authorities to approve pending applications or supplements to approved applications submitted by us or suspension or revocation of product license approvals; ● suspension of production or distribution; ● product seizure or detention or refusal to permit the import or export of products; and ● injunctions or the imposition of civil, criminal and/or administrative penalties, damages, monetary fines, debarment, restitution, disgorgement, exclusion from participation in governmental reimbursement programs, such as Medicare, Medicaid and other federal health care programs and curtailment or restructuring of our operations.
If our licensors, licensees or collaborators are not fully cooperative or disagree with the Company as to the prosecution, maintenance or enforcement of any patent rights, such patent rights could be compromised.
If our licensors, licensees or collaborators are not fully cooperative or disagree with us as to the prosecution, maintenance or enforcement of any patent rights, such patent rights could be compromised.
Because we have limited financial and managerial resources, we must focus on a limited number of research programs and product candidates and on specific indications. As a result, we may forego or delay pursuit of opportunities with other product candidates or for other indications that later prove to have greater commercial potential.
Because we have limited financial and managerial resources, we must focus on a limited number of research programs and product candidates and on specific indications. As a result, we may forego or delay pursuit of opportunities 43 Table of Contents with other product candidates or for other indications that later prove to have greater commercial potential.
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.
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 45 Table of Contents outside of our control, could result in an ownership change.
Shares that we may issue in the future in 73 Table of Contents connection with certain capital-raising transactions and shares available for future issuance upon exercise of warrants and options could dilute our stockholders and depress the market price of our common stock and result in the adjustment of the conversion terms of our existing securities.
Shares that we may issue in the future in connection with certain capital-raising transactions and shares available for future issuance upon exercise of warrants and options could dilute our stockholders and depress the market price of our common stock and result in the adjustment of the conversion terms of our existing securities.
Additionally, our CMOs may experience manufacturing difficulties due to resource constraints, including manufacturing capacity, material constraints, or as a result of labor disputes or unstable political environments.
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.
It is possible that the Health Care Reform Law, as currently enacted or may be amended or otherwise modified in the future, as well as other health care reform measures that may be adopted in the future, may result in additional reductions in Medicare payment and other health care financing, more rigorous coverage criteria, and new payment methodologies and in additional downward pressure on coverage and payment and the price that we receive for any 66 Table of Contents approved product.
It is possible that the Health Care Reform Law, as currently enacted or may be amended or otherwise modified in the future, as well as other health care reform measures that may be adopted in the future, may result in additional reductions in Medicare payment and other health care financing, more rigorous coverage criteria, and new payment methodologies and in additional downward pressure on coverage and payment and the price that we receive for any approved product.
Due to the Statutory Pay-As-You-Go Act of 2010, estimated budget deficit increases resulting from the American Rescue Plan Act of 2021, and subsequent legislation, Medicare payments to providers will be further reduced starting in 2025 absent further legislation. The U.S.
Due to the Statutory Pay-As-You-Go Act of 2010, estimated budget deficit increases resulting from the American Rescue Plan Act of 2021, and subsequent legislation, Medicare payments to providers were further reduced starting in 2025 absent further legislation. The U.S.
For these purposes, an ownership change generally occurs in the event of a cumulative change in ownership of the Company of more than 50% within any three-year period.
For these purposes, an ownership change generally occurs in the event of a cumulative change in ownership of us of more than 50% within any three-year period.
If we or others identify undesirable side effects caused by our product candidates either before or after receipt of marketing approval, a number of potentially significant negative consequences could result, including: ● our clinical trials may be put on hold; ● we may be unable to obtain regulatory approval for our product candidates; ● regulatory authorities may withdraw approvals of our products; ● regulatory authorities may require additional warnings on the label; 48 Table of Contents ● a medication guide outlining the risks of such side effects for distribution to patients may be required; ● we could be sued and held liable for harm caused to patients; and ● our reputation may suffer.
If we or others identify undesirable side effects caused by our product candidates either before or after receipt of marketing approval, a number of potentially significant negative consequences could result, including: ● our clinical trials may be put on hold; ● we may be unable to obtain regulatory approval for our product candidates or additional indications; ● regulatory authorities may withdraw approvals of our products; ● regulatory authorities may require additional warnings on the label or other label modifications; ● a medication guide outlining the risks of such side effects for distribution to patients may be required; ● we could be sued and held liable for harm caused to patients; and ● our reputation may suffer.
Increases in interest rates on credit and debt that would increase the cost of any borrowing that we may make from time to time and could impact our ability to access the capital markets. Tax laws could change.
Such uncertainty, and related increases in interest rates on credit and debt that would increase the cost of any borrowing that we may make from time to time, could impact our ability to access the capital markets. Tax laws could change.
In addition, any future partnerships we may enter into pose a number of risks, including that our partners may breach their agreements with the Company, and we may not be able to adequately protect our rights under these agreements.
In addition, any future partnerships we may enter into pose a number of risks, including that our partners may breach their agreements with us, and we may not be able to adequately protect our rights under these agreements.
Regulatory authorities enforce these GCP requirements through periodic inspections of trial sponsors, clinical investigators and trial sites. We cannot be certain 41 Table of Contents that, upon inspection, such regulatory authorities will determine that any of our clinical trials complies with GCP requirements.
Regulatory authorities enforce these GCP requirements through periodic inspections of trial sponsors, clinical investigators and trial sites. We cannot be certain that, upon inspection, such regulatory authorities will determine that any of our clinical trials complies with GCP requirements.
We may also 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. Additional funds may not be available when we need them on terms that are acceptable to us, or at all.
We may also 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. Additional funds may not be available when we 36 Table of Contents need them on terms that are acceptable to us, or at all.
If we fail to attract and keep senior management and key scientific personnel, we may be unable to successfully develop our products, conduct our clinical trials and commercialize our product candidates. We are highly dependent on members of our senior management, including Dr. Vipin Garg, our President and Chief Executive Officer, Gregory Weaver, our Chief Financial Officer, Dr.
If we fail to attract and keep senior management and key scientific personnel, we may be unable to successfully develop our products, conduct our clinical trials and commercialize our product candidates. We are highly dependent on members of our senior management, including Jerome Durso, our President and Chief Executive Officer, Gregory Weaver, our Chief Financial Officer, Dr.
Any of these outcomes could impair our ability to prevent competition from third parties, which may have an adverse impact on our business. 52 Table of Contents Any loss of, or failure to obtain, patent protection could have a material adverse impact on our business.
Any of these outcomes could impair our ability to prevent competition from third parties, which may have an adverse impact on our business. Any loss of, or failure to obtain, patent protection could have a material adverse impact on our business.
In addition, recent developments in the national and worldwide supply chain slowdown, including as a result of the conflict in Israel and the Gaza Strip, and the conflict in Ukraine, have resulted in increased cost and reduced supply for supplies and materials.
In addition, recent developments in the national and worldwide supply chain slowdown, including as a result of the geopolitical 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.
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 issues 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.
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 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.
Reliance on third-party manufacturers entails risks to which we would not be subject if we manufactured the product candidates ourself, including: ● the inability to negotiate manufacturing agreements with third parties under commercially reasonable terms; ● reduced control as a result of using third-party manufacturers for all aspects of manufacturing activities, including regulatory compliance and quality assurance.
Reliance on third-party manufacturers entails risks to which we would not be subject if we manufactured the product candidates ourself, including: ● potential limitations on our ability to negotiate manufacturing agreements with third parties under commercially reasonable terms; ● reduced control as a result of using third-party manufacturers for all aspects of manufacturing activities, including regulatory compliance and quality assurance.
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.
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 48 Table of Contents potentially over many years.
Accordingly, despite our efforts, we may not be able to prevent third parties from infringing upon or misappropriating our intellectual property. 53 Table of Contents Patent assertion, including initiating litigation, increases the likelihood that the accused third party will seek to narrow or invalidate our asserted patent.
Accordingly, despite our efforts, we may not be able to prevent third parties from infringing upon or misappropriating our intellectual property. Patent assertion, including initiating litigation, increases the likelihood that the accused third party will seek to narrow or invalidate our asserted patent.
Our failure, or the failure of our third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed, including 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 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.
Any unexpected development in the regulatory approval process, including delays or denials of regulatory approvals or significant modifications to our product candidates required by our regulators, could materially and adversely affect our business, results of operations and financial condition, and could substantially harm our stock price.
Any unexpected developments in the regulatory approval process, including delays or denials of regulatory approvals or significant modifications to our product candidates required by regulatory authorities, could materially and adversely affect our business, results of operations and financial condition, and could substantially harm our stock price.
Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we have patent protection, but enforcement rights are not as strong as those in the United States.
Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we have patent protection, but enforcement rights are not as strong as 51 Table of Contents those in the United States.
From time to time, we publish interim data, including interim top-line results or preliminary results from our clinical trials. Any interim data and other results from our clinical trials may materially change as more patient data become available.
From time to time, we may publish interim data, including top-line or preliminary data 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 data become available.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeRisk Management and Strategy Our cybersecurity risk management program is comprised of the following components: ● Identifying assets at risk from cybersecurity threats and taking mitigation measures including the implementation of data backup, recovery and restore procedures to ensure business continuity, as well as through IT controls, policies and infrastructure. ● Identifying potential cybersecurity threats that could disrupt our IT systems, cause a data breach or compromise data security by implementing the following protective measures: patching and updating systems and applications, monitoring our email systems, endpoint protection, Domain Name System (DNS) filtering, Security Information and Event Management, and Multi-Factor Authentication (MFA). ● Conducting periodic assessment of protections to prevent or mitigate cybersecurity threats. ● Retaining of third parties to periodically assess our cybersecurity management program , provide cybersecurity training, perform phishing tests, gap analysis and penetration tests, advise on business continuity plans, and to provide additional support in the event of a cybersecurity incident.
Biggest changeOur cybersecurity risk management program is comprised of the following components: ● Identifying assets at risk from cybersecurity threats and taking mitigation measures including the implementation of data backup, recovery and restore procedures to address business continuity, as well as through IT controls, policies and infrastructure. ● Identifying potential cybersecurity threats that could disrupt our IT systems, cause a data breach or other incident or compromise data security by implementing several protective measures. ● Conducting periodic assessment of protections to prevent or mitigate cybersecurity threats. ● The Company has processes to oversee and identify risks from cybersecurity threats associated with its use of third-party service providers and vendors. ● Retaining third parties to periodically assess our cybersecurity management program , provide cybersecurity training, perform phishing tests, gap analyses and penetration tests, advise on business continuity plans, and to provide additional support in the event of a cybersecurity incident.
Our Senior Director of Information Technology is responsible for the development and implementation of IT department controls, policies, infrastructure, and day-to-day operations, in addition to managing security risk, evaluating safeguards and recommending security improvements, and has over eight years of experience managing IT departments for a biotechnology company.
Our Senior Director of Information Technology is responsible for the development and implementation of IT department controls, policies, infrastructure, and day-to-day operations, in addition to managing security risk, evaluating safeguards and recommending security improvements, and has over nine years of experience managing IT departments, including with respect to cybersecurity, for a biotechnology company.
The Chief Financial Officer and Senior Director of Information Technology work with other groups in the Company to understand the severity of the potential consequences of a cybersecurity incident and to make decisions about 74 Table of Contents how to prioritize mitigation and other initiatives based on, among other things, materiality to the business.
While risks from cybersecurity threats or incidents have not materially affected our strategy, results of operations, or financial condition to date, the Chief Financial Officer, Chief Legal Officer and Senior Director of Information Technology work with other groups in the Company to understand the severity of the potential consequences of a cybersecurity incident and to make decisions about how to prioritize mitigation and other initiatives based on, among other things, materiality to the business.
We utilize third-party vendors to help strengthen our information security risk management by conducting evaluations of our security controls on at least a quarterly basis.
These individuals are informed of cybersecurity risks on an ongoing basis in part via our utilization of third-party vendors, which we utilize to help strengthen our information security risk management by conducting evaluations of our security controls on at least a quarterly basis.
Our Chief Financial Officer has overall responsibility for our cybersecurity and has over 30 years of experience managing information technology, or IT, departments at biotechnology and pharmaceutical companies.
The Audit Committee is composed of members with financial expertise as well as one member with a cybersecurity oversight certification. Our Chief Financial Officer has overall responsibility for our cybersecurity and has over 30 years of experience managing information technology, or IT, departments at biotechnology and pharmaceutical companies.
The Audit Committee receives regular reports, on a quarterly basis, from our Chief Financial Officer and Senior Director of Information Technology regarding our cybersecurity risk programs. Our Chief Financial Officer also provides quarterly updates to the Board that include a summary of our cybersecurity risk programs to enable discussion of cybersecurity risk management at the Board level.
The Audit Committee receives quarterly reports from our Chief Financial Officer, Chief Legal Officer and Senior Director of Information Technology regarding our cybersecurity risk programs.
Removed
The Audit Committee annually reviews and recommends our information security policy and program to the Board. The Audit Committee is composed of members with financial expertise as well as one member with a cybersecurity oversight certification.
Added
Our Chief Legal Officer also provides periodic updates to the Board, addressing the Company’s expanded Enterprise Risk Management program and assessments, that include summaries of our cybersecurity risk programs to enable discussion of cybersecurity risk management at the Board level. The Audit Committee annually reviews and recommends our information security policy and program to the Board.
Added
Our Chief Legal Officer has over 30 years of experience in federal law enforcement, life sciences legal and compliance programs, risk management and corporate governance responsibilities.
Added
Enterprise Risk Management and Strategy In 2025, the Company established its Enterprise Risk Management (“ERM”) program, as part of which the Company periodically reviews and assesses the most significant and likely risks to the enterprise, the strategies the Company has implemented to mitigate such risks, and the likelihood that such risks will occur within a defined period of 76 Table of Contents time.
Added
As part of this process, each risk and mitigation is evaluated to determine if any additional steps to address the risk may be warranted. Management shares its ERM assessments on a quarterly basis with the Audit Committee to solicit input and feedback and periodically reports their assessments to the full Board of Directors.
Added
The Company’s ERM program includes cybersecurity as a component of the broader risks considered and assessed.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeThe complaint is based upon allegations that are similar to those alleged in the Class Action and alleges claims for contribution, breaches of fiduciary duty, unjust enrichment, and waste of corporate assets based on the defendants purportedly making or causing to be made false and misleading statements and omissions of material fact between December 1, 2023 and April 26, 2024.
Biggest changeThe complaint was based upon allegations that were similar to those alleged in a class action complaint previously filed against us in the Securities Class Action and alleged claims for violations of Section 14(a) of the Securities Exchange Act of 1934, breaches of fiduciary duty, unjust enrichment, abuse of control, gross mismanagement, waste of corporate assets, and contribution under Sections 10(b) and 21D of the Securities Exchange Act of 1934 based on the defendants purportedly making or causing to be made false and misleading statements and omissions of material fact between August 10, 2023 and June 25, 2025.
The results of any current or future litigation cannot be predicted with certainty, and regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources, and other factors. Item 4. Mine Safety Disclosures Not applicable. 75 Table of Contents PART II
The results of any current or future litigation cannot be predicted with certainty, and regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors. Item 4. Mine Safety Disclosures Not applicable. 78 Table of Contents PART II
The complaint alleges that the defendants violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, and Rule 10b-5 thereunder, by making false and misleading statements and omissions of material fact to the investing public including the plaintiff and class members, who purchased or otherwise acquired our common stock between December 1, 2023 and April 26, 2024.
The Securities Class Action alleged that the defendants violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, and Rule 10b-5 thereunder, by making false and misleading statements and omissions of material fact to the investing public including the plaintiff and class members, who purchased or otherwise acquired the Company’s common stock between August 10, 2023 and June 25, 2025, including relating to pemvidutide and our IMPACT Phase 2b trial of pemvidutide in MASH.
Item 3. Legal Proceedings On May 6, 2024, a class action complaint was filed in federal district court in the District of Maryland, Southern Division, naming as defendants us and three of our executive officers, which is now captioned In re Altimmune, Inc. Securities Litigation, No. 24-cv-01315 (D. Md.) (the “Class Action”).
Item 3. Legal Proceedings On August 5, 2025, a class action complaint was filed in federal district court in the District of Maryland, Southern Division, naming as defendants the Company and two of the Company’s executive officers, which was captioned In re Altimmune, Inc. Securities Litigation , Case No. 8:25-cv-02581 (D. Md.) (the “Securities Class Action”).
From time to time, we may be involved in various legal proceedings or investigations, which could be costly and impose a significant burden on management and employees.
The complaint sought unspecified monetary relief, restitution, costs, and equitable relief. On December 22, 2025, the parties filed a stipulation of dismissal without prejudice, which the Court granted on that date. From time to time, we may be involved in various legal proceedings or investigations, which could be costly and impose a significant burden on management and employees.
The plaintiff and class members seek to have the action maintained as a class action under Rule 23 of the Federal Rules of Civil Procedure and for the defendants to pay damages, interest, and an award of costs, including attorneys’ fees. A substantially similar complaint, captioned Campanile v. Altimmune, Inc., et al. , No. 8:24-cv-01918 (D.
The plaintiff and class members sought, among other things, to have the action maintained as a class action under Rule 23 of the Federal Rules of Civil Procedure and for the defendants to pay damages, interest, and an award of costs, including attorneys’ fees. On October 16, 2025, the court appointed lead plaintiffs for the litigation.
Removed
Md.), was also filed in the same court by another plaintiff on July 1, 2024 against the Company and three of its executive officers, based upon the same general set of allegations and class period. On October 2, 2024, the court consolidated the Campanile action with the Class Action for all purposes and appointed lead plaintiffs for the consolidated litigation.
Added
On October 29, 2025, the court entered an order requiring lead plaintiffs to file an amended complaint by November 26, 2025, and for defendants to file an answer or notice of intent to file a motion to dismiss such amended complaint by December 10, 2025.
Removed
On December 16, 2024, the lead plaintiffs filed a notice of voluntary dismissal of the Class Action without prejudice, and on December 30, 2024, the court ordered that the Class Action be dismissed without prejudice, and the case was closed.
Added
Rather than amend, the lead plaintiffs sought voluntary dismissal without prejudice of the action, which the Court granted on November 26, 2025. 77 Table of Contents On September 29, 2025, a shareholder derivative complaint was filed in federal district court in the District of Maryland, purportedly on behalf of the Company, naming as defendants two of the Company’s then-executive officers and eight of the Company’s current and former board members, captioned Alaraidah v.
Removed
On June 4, 2024, a shareholder derivative complaint was filed in federal district court in the District of Delaware, purportedly on behalf of us, naming as defendants three of our executive officers and eight of our board members, which is now captioned In re Altimmune, Inc. Stockholder Derivative Litigation , No. 1:24-cv-669 (D. Del.) (the “Derivative Action”).
Added
Altimmune, Inc., et al. , No. 8:25-cv-03223 (D. Md.) (the “Derivative Action”).
Removed
The complaint seeks unspecified monetary relief, exemplary damages, restitution, contribution, and costs, as well as equitable relief. A similar shareholder derivative complaint, captioned Alaraidah v. Garg, et al., No. 1:24-cv-00772 (D.
Removed
Del.), was filed in the same court by another plaintiff on July 1, 2024, based upon substantially similar allegations, and alleges claims for contribution, breach of fiduciary duties, unjust enrichment, abuse of control, gross mismanagement, and waste of corporate assets and seeks unspecified monetary relief, restitution, costs, and equitable relief.
Removed
These actions were consolidated for all purposes on July 18, 2024 into the Derivative Action. On February 3, 2025, pursuant to a joint stipulation of the parties, the court ordered that the Derivative Action be dismissed without prejudice and the case was closed.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeSecurities Authorized for Issuance under Equity Compensation Plans Information about our equity compensation plans is contained in Part III, Item 12 of this Annual Report under the heading Equity Compensation Plans and is incorporated herein by reference. Recent Sales of Unregistered Securities None.
Biggest changeSecurities Authorized for Issuance under Equity Compensation Plans Information about our equity compensation plans will be included in our definitive proxy statement to be filed with the SEC with respect to our 2026 Annual Meeting of Stockholders and is incorporated herein by reference. Recent Sales of Unregistered Securities None.
Purchases of Equity Securities by the Issuer and Affiliated Purchases None. ​ Item 6. [Reserved] ​ 76 Table of Contents
Purchases of Equity Securities by the Issuer and Affiliated Purchases None. ​ Item 6. [Reserved] ​ 79 Table of Contents
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Market Information Our common stock trades on the NASDAQ Global Market under the symbol “ALT”. Holders As of February 24, 2025, we had 187 record holders of our common stock.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Market Information Our common stock trades on the Nasdaq Global Market under the symbol “ALT”. Holders As of February 27, 2026, we had 193 record holders of our common stock.

Item 6. [Reserved]

Selected Financial Data — reserved (removed by SEC in 2021)

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Biggest changeItem 6. ​ [ Reserved ] ​ 76 Item 7. ​ Management’s Discussion and Analysis of Financial Condition and Results of Operations ​ 77 Item 7A. ​ Quantitative and Qualitative Disclosures about Market Risk ​ 84 Item 8. ​ Financial Statements and Supplementary Data ​ 85
Biggest changeItem 6. ​ [ Reserved ] ​ 79 Item 7. ​ Management’s Discussion and Analysis of Financial Condition and Results of Operations ​ 80 Item 7A. ​ Quantitative and Qualitative Disclosures about Market Risk ​ 88 Item 8. ​ Financial Statements and Supplementary Data ​ 89

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

31 edited+33 added−23 removed34 unchanged
Biggest changeAdditionally, if and when we believe a regulatory approval of the first product candidate appears likely, we anticipate an increase in staffing and related expenses as a result of our preparation for commercial operations, especially as it relates to the sales and marketing of our product candidates. 79 Table of Contents Results of Operations Comparison of years ended December 31, 2024 and December 31, 2023 (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ ​ 2024 2023 Increase (Decrease) Revenues ​ $ 20 ​ $ 426 ​ $ (406) (95) % Operating expenses: ​ ​ ​ ​ ​ Research and development ​ 82,226 ​ 65,799 ​ 16,427 25 % General and administrative ​ 20,966 ​ 18,137 ​ 2,829 16 % Impairment loss on intangible asset ​ ​ — ​ ​ 12,419 ​ ​ (12,419) ​ (100) % Total operating expenses ​ 103,192 ​ 96,355 ​ 6,837 7 % Loss from operations ​ (103,172) ​ (95,929) ​ 7,243 8 % Other income (expense): ​ ​ ​ ​ ​ Interest expense ​ (9) ​ (35) ​ (26) (74) % Interest income ​ 8,074 ​ 7,351 ​ 723 10 % Other income (expense), net ​ 48 ​ 166 ​ (118) (71) % Total other income (expense), net ​ 8,113 ​ 7,482 ​ 631 8 % Net loss ​ $ (95,059) ​ $ (88,447) ​ $ 6,612 7 % ​ Revenue We have not generated any revenues from the sale of any products to date.
Biggest changeAdditionally, if and when we believe a regulatory approval of the first product candidate appears likely, we anticipate an increase in staffing and related expenses as a result of our preparation for commercial operations, especially as it relates to the sales and marketing of our product candidates. 82 Table of Contents Results of Operations Comparison of years ended December 31, 2025 and December 31, 2024 (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ ​ ​ ​ ​ 2025 ​ ​ ​ 2024 ​ ​ ​ Increase (Decrease) Revenues ​ $ 41 ​ $ 20 ​ $ 21 105 % Operating expenses: ​ ​ ​ ​ ​ ​ ​ ​ Research and development ​ 66,432 ​ 82,226 ​ (15,794) (19) % General and administrative ​ 28,098 ​ 20,966 ​ 7,132 34 % Total operating expenses ​ 94,530 ​ 103,192 ​ (8,662) (8) % Loss from operations ​ (94,489) ​ (103,172) ​ (8,683) (8) % Other income (expense): ​ ​ ​ ​ ​ ​ ​ ​ Interest expense ​ (1,636) ​ (9) ​ 1,627 * % Interest income ​ 7,541 ​ 8,074 ​ (533) (7) % Other income (expense), net ​ (190) ​ 48 ​ (238) (496) % Total other income (expense), net ​ 5,715 ​ 8,113 ​ (2,398) (30) % Net loss before income taxes ​ ​ (88,774) ​ ​ (95,059) ​ ​ 6,285 (7) % Income tax expense (benefit) ​ (681) ​ — ​ (681) * % Net loss ​ $ (88,093) ​ $ (95,059) ​ $ (6,966) (7) % *Indicates the percentage change period over period is not meaningful due to zero or negligible amount in the prior period.
Costs for certain development activities are recognized based on an evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors, CROs and clinical sites. 78 Table of Contents We cannot determine with certainty the duration and completion costs of the current or future clinical trials of our product candidates or if, when or to what extent we will generate sales from the commercialization of any of our product candidates if they receive regulatory approval.
Costs for certain development activities are recognized based on an evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors, CROs and clinical sites. 81 Table of Contents We cannot determine with certainty the duration and completion costs of the current or future clinical trials of our product candidates or if, when or to what extent we will generate sales from the commercialization of any of our product candidates if they receive regulatory approval.
We believe, based on the operating cash requirements and capital expenditures expected for 2025 and 2026, our cash on hand as of December 31, 2024, 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, 2024 consolidated financial statements.
We believe, based on the operating cash requirements and capital expenditures expected for 2026 and 2027, our cash on hand as of December 31, 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, 2025 consolidated financial statements.
Our sources of cash provided by operations during the year ended December 31, 2024 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.
Our sources of cash provided by operations during the year ended December 31, 2025 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.
We estimate forfeitures at the time of grant and, if necessary, revise the estimate in subsequent periods if actual forfeitures differ from those estimates. Estimates are based on our historical analysis of actual stock option forfeitures. 83 Table of Contents The actual expense recognized over the vesting period is only for those options that vest.
We estimate forfeitures at the time of grant and, if necessary, revise the estimate in subsequent periods if actual forfeitures differ from those estimates. Estimates are based on our historical analysis of actual stock option forfeitures. 87 Table of Contents The actual expense recognized over the vesting period is only for those options that vest.
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.
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.
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 December 31, 2024 consolidated financial statements.
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 December 31, 2025 consolidated financial statements.
Critical Accounting Estimates Our management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles.
Critical Accounting Estimates Our management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles, or GAAP.
The net cash provided by financing activities during the year ended December 31, 2024 was primarily the result of the receipt of $10.0 million in net proceeds from the issuance of common stock from our at-the-market offerings program, $0.4 million in proceeds from exercise of stock options, $0.3 million in proceeds from our employee stock purchase plan and $0.2 million proceeds from exercises of stock warrants, partially offset by a $0.9 million payment for tax withholding obligations related to share-based compensation.
The net cash provided by financing activities during the year ended December 31, 2024 was primarily the result of the receipt of $10.0 million in net proceeds from the issuance of common stock from our at-the-market offerings program, $0.4 million in proceeds from exercise of stock options, $0.3 million in proceeds from our ESPP and $0.2 million proceeds from exercises of stock warrants, partially offset by $0.9 million payment for tax withholding obligations related to share-based compensation.
However, in order to address our capital needs in the long-term, including our planned 82 Table of Contents 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.
However, in order to address our capital needs in the long-term, including our planned 86 Table of Contents 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.
For the years ended December 31, 2024 and 2023, forfeiture rates were approximately 9% and 11% respectively. We calculated the fair value of stock option awards using the Black Scholes option pricing model. The Black Scholes option pricing model requires the input of subjective assumptions, including stock price volatility and the expected life of stock options.
For each of the years ended December 31, 2025 and 2024, forfeiture rates were approximately 9%. We calculated the fair value of stock option awards using the Black-Scholes option pricing model. The Black-Scholes option pricing model requires the input of subjective assumptions, including stock price volatility and the expected life of stock options.
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, we had an accumulated deficit of $561.4 million. In addition, we have not generated positive cash flows from operations.
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, 2025, we had an accumulated deficit of $649.5 million. In addition, we have not generated positive cash flows from operations.
Capital Resources We have financed our operations to date principally through our equity offerings and proceeds from issuances of our preferred stock, common stock and warrants. As of December 31, 2024, we had $131.9 million of cash, cash equivalents, restricted cash and short-term investments.
Capital Resources We have financed our operations to date principally through our equity offerings and proceeds from issuances of our preferred stock, common stock and warrants. As of December 31, 2025, we had $273.5 million of cash, cash equivalents, restricted cash and short-term investments.
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. We do not allocate personnel-related costs, costs associated with our general research platform improvements, depreciation or other indirect costs to specific programs.
A significant portion of our research and development efforts have been related to the development of pemvidutide. We do not allocate personnel-related costs, costs associated with our general research platform improvements, depreciation or other indirect costs to specific programs.
Liquidity and Capital Resources Overview Our primary sources of cash for the year ended December 31, 2024 were from equity transactions, interest and dividends 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 million as of December 31, 2024.
Liquidity and Capital Resources Overview Our primary sources of cash for the year ended December 31, 2025 were from equity transactions, debt, interest income 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 $273.5 million as of December 31, 2025.
Investing Activities Net cash used in investing activities was $28.4 million for the year ended December 31, 2024 compared to $13.7 million net cash provided by investing activities during the year ended December 31, 2023.
Investing Activities Net cash used in investing activities was $132.5 million for the year ended December 31, 2025 compared to $28.4 million net cash provided by investing activities during the year ended December 31, 2024.
Our current active and planned research and development activities include the following: ● completion of data analysis of a Phase 2 clinical trial for pemvidutide in obesity; ● conduct of a Phase 2 clinical trial for pemvidutide in MASH; ● conduct of clinical trials and nonclinical safety studies for pemvidutide; ● conduct of additional research and discovery projects; and ● manufacture of clinical trial materials in support of our clinical trials.
Our current active and planned research and development activities include the following: ● conduct of Phase 3 clinical trial for pemvidutide in MASH; ● conduct of clinical trials for AUD and ALD; ● conduct of clinical trials and nonclinical safety studies for pemvidutide; ● conduct of additional research and discovery projects; and ● manufacture of clinical trial materials in support of our clinical trials.
Financing Activities Net cash provided by financing activities was $10.0 million for the year ended December 31, 2024 compared to $86.1 million during the year ended December 31, 2023.
Financing Activities Net cash provided by financing activities was $206.8 million for the year ended December 31, 2025 compared to $10.0 million during the year ended December 31, 2024.
The net cash provided by investing activities during the year ended December 31, 2023 was primarily due to $102.4 million proceeds from sale and maturities of short-term investments, partially offset by $88.6 million purchase of short-term investments.
The net cash used in investing activities during the year ended December 31, 2025 was primarily due to $285.4 million purchase of short-term investments, partially offset by $153.0 million proceeds from sale and maturities of short-term investments.
The increase in cash used in operating activities of $4.0 million was due to a $16.8 million increase in net loss as adjusted for noncash items, partially offset by a $12.8 million change in working capital accounts.
The decrease in cash used in operating activities of $12.3 million was due to a $10.0 million decrease in net loss as adjusted for noncash items and a $2.3 million change in working capital accounts.
The net cash provided by financing activities during the year ended December 31, 2023 was primarily the result of the receipt of $86.4 million in net proceeds from the issuance of common stock from our at-the-market offerings program, $0.1 million in proceeds from exercise of stock options and $0.2 million in proceeds from employee stock purchase plan, partially offset by $0.5 million payment for tax withholding obligations related to share-based compensation.
The net cash provided by financing activities during the year ended December 31, 2025 was primarily the result of the receipt of $173.3 million in net proceeds from the issuance of common stock from our at-the-market offerings program, $33.9 million in net proceeds from the Term Loan and $0.3 million in proceeds from our ESPP, partially offset by a $0.7 million payment for tax withholding obligations related to share-based compensation.
Sources of Liquidity Shelf Registrations On February 28, 2023, we filed a shelf registration statement on Form S-3ASR, which was declared effective immediately. This shelf registration allowed us to offer and sell any amount of our common stock, preferred stock, debt securities, warrants, rights and units (the “2023 Shelf”).
This shelf registration allows us to offer and sell up to $400.0 million of our common stock, preferred stock, debt securities, warrants, rights and units (the “February 2025 Shelf”) for a period of 3 years from effectiveness. On February 28, 2023, we filed a shelf registration statement on Form S-3ASR, which was declared effective immediately.
Our revenues in previous years consisted primarily of government and foundation grants and contracts that supported our efforts on specific research projects. These grants and contracts generally provided for reimbursement of approved costs as those costs were incurred by us.
Our revenues in previous years consisted primarily of government and foundation grants and contracts that supported our efforts on specific research projects.
At-the-Market Offerings On February 28, 2023, we entered an Equity Distribution Agreement (the “2023 Agreement”) with Evercore Group L.L.C., JMP Securities LLC and B.
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 an Equity Distribution Agreement (the “2023 Agreement”) with Evercore Group L.L.C., JMP Securities LLC and B.
Total other income (expense), net Total other income (expense), net increased by $0.6 million during the year ended December 31, 2024 as compared to the year ended December 31, 2023, primarily due to a $0.7 million increase in interest income earned on our cash equivalents and short-term investments.
The net decrease was primarily due to a $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.
Overview Altimmune, Inc. is a clinical stage biopharmaceutical company focused on developing treatments for obesity, metabolic and liver diseases. Our lead product candidate, pemvidutide (formerly known as ALT-801), is a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist. Pemvidutide is currently in clinical development for obesity and metabolic associated steatohepatitis (MASH).
Overview Altimmune, Inc. is a late clinical-stage biopharmaceutical company developing novel therapies for serious liver diseases. Our lead product candidate, pemvidutide (formerly known as ALT-801), is a balanced 1:1 glucagon/GLP-1 dual receptor agonist in development for the treatment of MASH, AUD and ALD. We may also pursue additional indications for pemvidutide that leverage its differentiated clinical profile.
The increase in other non-project specific research and development expenses was primarily due to a $1.6 million increase in stock compensation expense and a $1.3 million initial cost for additional research and discovery projects. 80 Table of Contents General and administrative expenses General and administrative expenses increased by $2.8 million, or 16%, during the year ended December 31, 2024 as compared to the year ended December 31, 2023, primarily due to a $2.7 million increase in stock compensation and other labor-related expenses, including the $1.0 million incremental stock-based compensation expense because of modifications of stock awards (see Note 9).
The decrease in research and development expenses for HepTcell was due to the termination of HepTcell in March 2024. 83 Table of Contents General and administrative expenses General and administrative expenses increased by $7.1 million, or 34%, during the year ended December 31, 2025 as compared to the year ended December 31, 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 $1.4 million severance costs for our former executives.
Since inception through December 31, 2024, we raised approximately $96.6 million in net proceeds. 81 Table of Contents Cash Flows The following table provides information regarding our cash flows for the years ended December 31, 2024 and 2023: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, (in thousands) 2024 2023 Increase (Decrease) Net cash (used in) provided by: ​ ​ ​ Operating activities ​ $ (79,848) ​ $ (75,810) ​ $ 4,038 Investing activities ​ (28,386) ​ 13,732 ​ (42,118) Financing activities ​ 10,044 ​ 86,105 ​ (76,061) Net decrease (increase) in cash and cash equivalents and restricted cash ​ $ (98,190) ​ $ 24,027 ​ $ (122,217) ​ Operating Activities Net cash used in operating activities was $79.8 million for the year ended December 31, 2024 compared to $75.8 million during the year ended December 31, 2023.
The pre-funded warrants were fully exercised on February 13, 2026, resulting in the issuance of 4,647,534 shares of our common stock. 85 Table of Contents Cash Flows The following table provides information regarding our cash flows for the years ended December 31, 2025 and 2024: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, (in thousands) ​ ​ ​ 2025 ​ ​ ​ 2024 ​ ​ ​ Increase (Decrease) Net cash (used in) provided by: ​ ​ ​ ​ ​ ​ Operating activities ​ $ (67,535) ​ $ (79,848) ​ $ (12,313) Investing activities ​ (132,473) ​ (28,386) ​ (104,087) Financing activities ​ 206,842 ​ 10,044 ​ 196,798 Net increase (decrease) in cash and cash equivalents and restricted cash ​ $ 6,834 ​ $ (98,190) ​ $ 105,024 ​ Operating Activities Net cash used in operating activities was $67.5 million for the year ended December 31, 2025 compared to $79.8 million during the year ended December 31, 2024.
We also expect to pursue additional indications for pemvidutide that leverage the differentiated clinical profile of pemvidutide. Except where the context indicates otherwise, references to “we,” “us,” “our,” “Altimmune”, or the “Company” refer to the company and its subsidiaries.
Except where the context indicates otherwise, references to “we,” “us,” “our,” “Altimmune”, or the “Company” refer to the company and its subsidiaries. Fiscal Year 2025 Business Update MASH On June 26, 2025, we released 24-week topline efficacy results from IMPACT, a Phase 2b trial of pemvidutide in patients with MASH.
The decrease in research and development expenses for HepTcell was primarily due to the winddown and completion of the in-life portion of the Phase 2 trial in 2023. The research and development expenses for the year ended December 31, 2024 were due to program winddown activities.
The decrease in research and development expenses for MASH was primarily due to ongoing enrollment for the IMPACT Phase 2b trial in MASH during 2024 which was completed in early 2025.
As announced in November 2023, the trial enrolled 391 subjects with obesity or overweight with at least one comorbidity and without diabetes. Subjects were randomized 1:1:1:1 to 1.2 mg, 1.8 mg, 2.4 mg pemvidutide or placebo administered weekly for 48 weeks in conjunction with diet and exercise.
The Phase 2b trial enrolled 212 subjects with biopsy-confirmed MASH and fibrosis stages F2/F3 with and without diabetes randomized 1:2:2 to receive weekly subcutaneous doses of pemvidutide at 1.2 mg, 1.8 mg or placebo.
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Fiscal Year 2024 Business Update End-of-Phase 2 Meeting On November 7, 2024, we announced the successful completion of our End-of-Phase 2 Meeting with the U.S. Food and Drug Administration (the “FDA”) and agreement on the design of a Phase 3 registrational program for its product candidate, pemvidutide, in the treatment of obesity.
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The topline 24-week data showed that treatment with pemvidutide achieved statistically significant improvements in MASH resolution without worsening of fibrosis, improvements in fibrosis without worsening of MASH, and statistically significant changes in well-established NITs of fibrosis, including ELF score and LSM compared with placebo at both doses.
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The interaction with the FDA included an extensive review of the preclinical and clinical data generated to date, including data from six completed clinical trials of pemvidutide. The planned registrational program will include four Phase 3, randomized, double-blind, placebo-controlled, parallel-group trials, each evaluating treatment with pemvidutide over a 60-week period.
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On December 11, 2025, we held an End-of-Phase 2 meeting with the FDA to discuss and align on the parameters for a registrational Phase 3 trial of pemvidutide for MASH patients with moderate to advanced fibrosis with biopsy driven endpoints.
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The Phase 3 program is expected to enroll approximately 5,000 subjects across the four trials. The safety and efficacy of pemvidutide doses of 1.2 mg, 1.8 mg, and 2.4 mg will be evaluated with the intention of obtaining approval for all three doses.
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The FDA agreed to the use of AIM-MASH AI Assist, the first FDA-qualified AI pathology tool for MASH clinical trials, in our Phase 3 trial. We received final minutes from the End-of-Phase 2 meeting in January 2026, which we believe describe a clear regulatory path for a Phase 3 trial in MASH.
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The Phase 3 program is designed to leverage the key attributes of pemvidutide, including the effects of balanced GLP-1/glucagon dual agonism in subjects with overweight and obesity.
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We also intend to seek scientific advice from European regulators to further inform the final Phase 3 protocol. See Item 1. Business for additional information. On December 19, 2025, we announced positive 48-week topline results from the IMPACT Phase 2b trial of pemvidutide in patients with MASH.
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Pemvidutide – 12-Week Phase 1b trial On November 15, 2024, we presented new data derived from an analysis of plasma samples from subjects who completed a randomized placebo-controlled Phase 1b trial of pemvidutide in subjects with overweight or obesity and MASLD.
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The topline 48-week data from the IMPACT trial showed that treatment with pemvidutide achieved statistically significant improvements across treatment arms versus placebo in the key anti-fibrosis NITs of ELF and LSM. Additional Indications for Pemvidutide On March 13, 2025, we announced that we are pursuing two additional indications for our lead product candidate, pemvidutide.
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In the Phase 1b clinical trial, 94 subjects with obesity or overweight and liver fat content (LFC) ≥10% were dosed 1:1:1:1 to pemvidutide (1.2mg, 1.8mg and 2.4mg) or placebo administered once-weekly subcutaneously for 12 weeks.
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The new indications are AUD and ALD. AUD On May 19, 2025, we announced the enrollment of the first subject in the RECLAIM Phase 2 trial evaluating the efficacy and safety of pemvidutide in subjects with AUD. RECLAIM is a randomized, placebo-controlled trial conducted across approximately 15 sites in the United States, targeting enrollment of approximately 100 subjects.
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In this study, pemvidutide reduced LFC relative to baseline by up to 68.5% and decreased total cholesterol and triglycerides by up to 12.2% and 44.6%, respectively, after 12 weeks of treatment.
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On August 19, 2025, we announced that the U.S. Food and Drug Administration has granted Fast Track designation to pemvidutide for the treatment of AUD.
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Pemvidutide – IMPACT trial On September 30, 2024, we announced the completion of patient enrollment in IMPACT, our Phase 2b biopsy-driven trial evaluating Pemvidutide in MASH, and we expect top-line data in the second quarter of 2025.
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Fast Track designation is intended to accelerate the development and review of new drugs that target serious conditions and address unmet medical needs. 80 Table of Contents On November 3, 2025, we announced the completion of enrollment in the RECLAIM Phase 2 trial.
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Pemvidutide – MOMENTUM trial On September 10, 2024, we presented additional results of MRI-based body composition sub-study from our 48-week MOMENTUM Phase 2 obesity trial of pemvidutide in subjects with overweight and obesity at the 60 th annual meeting of the European Association for the Study of Diabetes.
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Enrollment completed ahead of schedule, underscoring strong interest from the patient community in a new therapeutic option for AUD. We are on track to complete the 24-week treatment period and announce topline results in 2026.
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The lean loss ratio, defined as the change in lean mass compared to the change in total mass, was 21.9%. Lean mass preservation was greater in subjects aged 60 years and older, in whom the lean loss ratio was only 19.9%.
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ALD On July 9, 2025, we announced the enrollment of the first patient in the RESTORE Phase 2 trial evaluating the efficacy and safety of pemvidutide in subjects with ALD. RESTORE is a randomized, placebo-controlled trial enrolling approximately 100 patients across 34 sites in the United States. See Item 1. Business for additional information.
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In addition to lean mass preservation, there was a preferential reduction of 77 Table of Contents visceral adipose tissue (VAT), the adipose tissue associated with cardiovascular risk. At the 2.4mg dose of pemvidutide, VAT was reduced by 28.3% at week 48 compared to a 19.5% loss in subcutaneous adipose tissue.
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Recent Global Events Tariffs and Inflation The United States recently imposed reciprocal and additional tariffs on many countries around the world. Such tariffs and counter tariffs by other countries against the U.S. have been causing uncertainties in the global markets and supply chain.
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On June 23, 2024, we presented the full results of the body composition analysis from our 48-week MOMENTUM Phase 2 obesity trial of pemvidutide at the American Diabetes Association’s 84 th Annual Scientific Sessions.
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If the tariffs and counter 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.
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In an MRI sub-study of 67 subjects from the MOMENTUM Phase 2 obesity trial, 50 of whom were treated with pemvidutide for 48 weeks, 78.1% of weight loss was derived from adipose tissue and only 21.9% from lean mass. Historically, lean mass loss has been shown to be approximately 25% from diet and exercise programs.
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Inflation generally affects us by increasing our employee-related costs and clinical trial expenses, as well as other operating expenses.
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The 1.2 mg and 1.8 mg doses were administered without dose titration, while a short 4-week titration period was employed for the 2.4 mg dose. At baseline, subjects had a mean age of approximately 50 years, mean body mass index (BMI) of approximately 37 kg/m 2 , and mean body weight of approximately 104 kg.
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Our financial condition and results of operations may also be impacted by other factors we may not be able to control, such as public health crises, global supply chain disruptions, uncertain global economic conditions, global trade disputes or political instability as further discussed in the section "Risk Factors" in this Annual Report on Form 10-K.
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Approximately 75% of subjects were female. HepTcell On March 27, 2024, we announced that the overall response in the Phase 2 trial was deemed to be insufficient to warrant further advancement in clinical trials. As a result, any further development related to HepTcell has been stopped.
Added
Research and development expenses Research and development expenses for the years ended December 31, 2025 and 2024 consisted primarily of expenses related to product candidate development, summarized as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ (in thousands) ​ ​ ​ 2025 ​ ​ ​ 2024 ​ ​ ​ Increase (Decrease) Pemvidutide ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ MASH ​ $ 20,649 ​ $ 36,965 ​ $ (16,316) ​ (44) % ALD ​ ​ 6,956 ​ ​ — ​ ​ 6,956 * % AUD ​ ​ 6,757 ​ ​ — ​ ​ 6,757 ​ * % Other pemvidutide expenses ​ ​ 8,027 ​ ​ 16,309 ​ ​ (8,282) ​ (51) % Total pemvidutide expenses ​ ​ 42,389 ​ ​ 53,274 ​ ​ (10,885) ​ (20) % HepTcell ​ — ​ 2,695 ​ (2,695) (100) % Additional discovery projects ​ ​ — ​ 1,336 ​ (1,336) (100) % Non-project costs ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Labor ​ ​ 10,475 ​ 10,026 ​ 449 4 % Stock compensation ​ ​ 6,166 ​ 6,351 ​ (185) (3) % Shared service and infrastructure ​ 7,402 ​ 8,544 ​ (1,142) (13) % Total research and development expenses ​ $ 66,432 ​ $ 82,226 ​ $ (15,794) (19) % *indicates the percentage change period over period is not meaningful due to zero amount in the prior period.
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Research grants and contracts and the related accounts receivable were recognized as earned when reimbursable expenses were incurred and the performance obligation was complete. Payments received in advance of services being provided were recorded as deferred revenue.
Added
The decrease in other pemvidutide expenses was primarily due to a $5.7 million decrease in manufacturing expenses and a $2.1 million decrease due to winding down of GLP-1 and other nonclinical activities. These decreases were partially offset by the increase in expense associated with the start of the AUD and ALD trials.
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We recently closed out one of the remaining such contracts, and the revenue reported during the year ended December 31, 2023 was primarily from the final indirect rate adjustments.
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Total other income (expense), net Total other income (expense), net decreased by $2.4 million during the year ended December 31, 2025 as compared to the year ended December 31, 2024.
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Our revenues in previous years consisted primarily of government and foundation grants and contracts that supported our efforts on specific research projects. We recently closed out one of the remaining such contracts, and the revenue reported during the year ended December 31, 2023 was primarily from the final indirect rate adjustments.
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Income tax expense (benefit) During the year ended December 31, 2025, we have recorded a discrete tax benefit of approximately $0.7 million related to a portion of carryback claims with the State of Maryland, which we previously held an uncertain tax position against.
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Research and development expenses Research and development expenses for the years ended December 31, 2024 and 2023 consisted primarily of expenses related to product candidate development.
Added
Other than the discrete tax benefit discussed above, due to a full valuation allowance, the Company did not record an income tax expense (benefit) for either of the years ended December 31, 2025 and 2024.
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Research and development expenses for the years ended December 31, 2024 and 2023 are summarized as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ Product candidates 2024 2023 Increase (Decrease) Pemvidutide ​ $ 53,274 ​ $ 35,768 ​ $ 17,506 49 % HepTcell ​ 2,695 ​ 7,380 ​ (4,685) (63) % Non-project costs ​ 26,257 ​ 22,651 ​ 3,606 16 % Total research and development expenses ​ $ 82,226 ​ $ 65,799 ​ $ 16,427 25 % The increase in research and development expenses for pemvidutide was primarily due to a $27.4 million increase related to the ramp up of the IMPACT Phase 2b trial in MASH, a $1.5 million increase for other clinical analysis, and a $2.2 million increase in nonclinical studies.
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Sources of Liquidity Loan Financing On May 13, 2025 (“Closing Date”), we entered into a Loan and Security Agreement (“Loan Agreement”) with Hercules Capital, Inc.
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These increases were partially offset by a $10.8 million reduction in expense associated with the MOMENTUM Phase 2 trial in obesity, which was ongoing during most of 2023 and wound down in the year ended December 31, 2023, and a $2.8 million reduction in expenses associated with the Phase 1 safety trial, which was substantially completed in 2023.
Added
(“Hercules”) and the lenders party thereto, pursuant to which the lenders will make available up to four tranches of term loans in an aggregate principal amount of $100.0 million (the “Term Loan”), subject to certain terms and conditions. The first Term Loan tranche was drawn down on the Closing Date in an aggregate principal amount of $15.0 million.
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In the coming months, we expect to have some additional wrap up costs as we finalize these activities.
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On November 5, 2025, (the “Amendment Closing”), we entered into an amendment to the Loan Agreement with Hercules and the lenders party thereto, pursuant to which the lenders will, subject to certain terms and conditions, increase the availability under the Term Loan from an aggregate principal amount of $100.0 million to $125.0 million.
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Impairment loss on intangible asset Impairment loss on intangible asset of $12.4 million reported during the year ended December 31, 2023 represents a non-cash impairment charge recorded for the in-process research and development (“IPR&D”) asset associated with HepTcell (See Note 2. Summary of Significant Accounting Policies ). There was no impairment charge reported during the year ended December 31, 2024.
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The Term Loan, as amended, is structured in four tranches. As disclosed above, the first Term Loan tranche was drawn down on the 84 Table of Contents Closing Date in an aggregate principal amount of $15.0 million. The second Term Loan tranche was drawn down on the Amendment Closing in an aggregate principal amount of $20.0 million.
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Upon the achievement of certain milestones and subject to other terms and conditions set out in the Loan Agreement, as amended, the third Term Loan tranche will be made available in an aggregate principal amount of up to $10.0 million.
Added
The fourth Term Loan tranche will be made available in an aggregate principal amount of up to $80.0 million subject to the approval of the lenders. The Term Loan, as amended, bears interest equal to the greater of (a) 9.70% per annum and (b) the prime rate as reported in The Wall Street Journal plus 2.45% per annum.
Added
The interest-only period has been extended to 30 months from May 13, 2025. Shelf Registrations On November 13, 2025, we filed a shelf registration statement on Form S-3, as amended, which was declared effective on December 5, 2025.

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