What changed in this filing

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Item 7. Management’s Discussion and Analysis

2026-03-06 compared with 2025-02-27 · 96 added, 73 removed, 146 unchanged (54% of the section changed)

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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).

We also expect to pursue additional indications for pemvidutide that leverage the differentiated clinical profile of pemvidutide.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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%.

In addition to lean mass preservation, there was a preferential reduction of

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.

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.

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.

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 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.

Approximately 75% of subjects were female.

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.

On June 26, 2025, we released 24-week topline efficacy results from IMPACT, a Phase 2b trial of pemvidutide in patients with MASH.

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.

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.

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.

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.

We also intend to seek scientific advice from European regulators to further inform the final Phase 3 protocol.

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.

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.

The new indications are AUD and ALD.

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.

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.

Fast Track designation is intended to accelerate the development and review of new drugs that target serious conditions and address unmet medical needs.

On November 3, 2025, we announced the completion of enrollment in the RECLAIM Phase 2 trial.

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.

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.

Business for additional information.

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.

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.

Inflation generally affects us by increasing our employee-related costs and clinical trial expenses, as well as other operating expenses.

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.

Financial Operations Overview

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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.

These grants and contracts generally provided for reimbursement of approved costs as those costs were incurred by us.

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.

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.

Research and development expenses

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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 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;

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● manufacture of clinical trial materials in support of our clinical trials.

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.

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.

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General and administrative

Impairment loss on intangible asset

Total operating expenses

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Total other income (expense), net

We have not generated any revenues from the sale of any products to date.

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.

Net loss before income taxes

Income tax expense (benefit)

*Indicates the percentage change period over period is not meaningful due to zero or negligible amount in the prior period.

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.

Research and development expenses for the years ended December 31, 2024 and 2023 are summarized as follows:

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,

Product candidates

(in thousands)

Increase (Decrease)

Other pemvidutide expenses

Total pemvidutide expenses

Additional discovery projects

Non-project costs

Stock compensation

Shared service and infrastructure

Total research and development expenses

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.

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.

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.

In the coming months, we expect to have some additional wrap up costs as we finalize these activities.

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.

*indicates the percentage change period over period is not meaningful due to zero amount in the prior period.

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.

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.

The decrease in research and development expenses for HepTcell was due to the termination of HepTcell in March 2024.

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).

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.

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.

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.

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.

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.

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.

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.

Liquidity and Capital Resources

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 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.

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As capital resources are consumed to fund our research and development activities, we may require additional capital beyond our currently anticipated amounts.

In order to address our capital needs, including our planned clinical trials, we must continue to actively pursue additional equity or debt financing, government funding, and monetization of our existing programs through partnership arrangements or sales to third parties.

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.

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.

(“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.

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.

The Term Loan, as amended, is structured in four tranches.

As disclosed above, the first Term Loan tranche was drawn down on the

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.

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.

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.

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.

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 “November 2025 Shelf”) for a period of 3 years from effectiveness.

On February 27, 2025, we filed a shelf registration statement on Form S-3, which was declared effective on March 13, 2025.

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.

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”).

The 2023 Shelf expired on February 27, 2025

At-the-Market Offerings

On November 6, 2025, we entered into an Equity Distribution Agreement (the “November 2025 Agreement”) with Leerink Partners LLC serving as sales agent, with respect to an at-the-market offerings program under which we may offer and sell shares of our common stock having an aggregate offering price of up to $200.0 million through the sales agent from the February 2025 Shelf.

Since inception through December 31, 2025, we raised approximately $25.4 million in net proceeds, with $174.2 million remaining available to be sold under the November 2025 Agreement.

On February 27, 2025, we entered into an Equity Distribution Agreement (the “February 2025 Agreement”) with Leerink Partners LLC, Piper Sandler & Co.

and Stifel, Nicolaus & Company, Incorporated, serving as sales agents, with respect to an at-the-market offerings program under which we offered and sold shares of our common stock having an aggregate offering price of up to $150.0 million through the sales agents from the February 2025 Shelf.

Since inception, through the termination of the February 2025 Agreement in November 2025, we raised approximately $118.3 million in net proceeds.

On February 28, 2023, we entered an Equity Distribution Agreement (the “2023 Agreement”) with Evercore Group L.L.C., JMP Securities LLC and B.

Riley Securities, Inc., serving as sales agents, with respect to an at-the-market offerings program under which we offered and sold shares of our common stock having an aggregate offering price of up to $150.0 million through the Sale Agents from the 2023 Shelf.

Since inception through December 31, 2024, we raised approximately $96.6 million in net proceeds.

Since inception through the termination of the 2023 Agreement in February 2025, we raised approximately $126.8 million in net proceeds.

Registered Direct Offering

On January 27, 2026, the Company entered into a securities purchase agreement with a new fundamental institutional investor pursuant to a registered direct offering under the November 2025 Shelf for the purchase and sale of 12,397,920 shares of its common stock and 4,647,534 pre-funded warrants for net proceeds of approximately $70.4 million.

The pre-funded warrants were fully exercised on February 13, 2026, resulting in the issuance of 4,647,534 shares of our common stock.

The following table provides information regarding our cash flows for the years ended December 31, 2025 and 2024:

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Financing activities

Net decrease (increase) in cash and cash equivalents and restricted cash

Net increase (decrease) in cash and cash equivalents and restricted cash

Operating Activities

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The primary uses of cash from our operating activities include payments for labor and labor-related costs, professional fees, research and development costs associated with our clinical trials and other general corporate expenditures.

The 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.

Investing Activities

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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 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, 2024 was primarily due to $115.7 million purchase of short-term investments, partially offset by $87.3 million proceeds from sale and maturities of short-term investments.

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 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, 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.

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.

Capital Resources

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However, in order to address our capital needs in the long-term, 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.

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.

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.

generally accepted accounting principles, or GAAP.

The preparation of our consolidated financial statements requires us to make judgments and estimates that affect the reported amounts of assets, liabilities, revenues and expenses, and the disclosure of contingent liabilities in our consolidated financial statements.

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The actual expense recognized over the vesting period is only for those options that vest.

For the years ended December 31, 2024 and 2023, forfeiture rates were approximately 9% and 11% respectively.

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.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 7. Management’s Discussion and Analysis