What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-05-13 compared with 2025-11-06 · 111 added, 127 removed, 84 unchanged (74% of the section changed)

Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis of our financial condition and results of operations should be read together with our consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and our consolidated financial statements and related notes for the year ended December 31, 2024 included in our Annual Report on Form 10-K, which was filed with the SEC on February 27, 2025.

The following discussion and analysis of our financial condition and results of operations should be read together with our consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and our consolidated financial statements and related notes for the year ended December 31, 2025 included in our Annual Report on Form 10-K, which was filed with the SEC on March 6, 2026.

This Quarterly Report on Form 10-Q contains forward-looking statements that involve substantial risks and uncertainties.

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Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make.

These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate, and management’s beliefs and assumptions.

These statements are not guarantees of future performance and involve certain risks, uncertainties and assumptions that are difficult to predict and may cause our actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by any forward-looking statements.

A further list and description of risks, uncertainties and other factors that could cause actual results or events to differ materially from the forward-looking statements that we make is included in the cautionary statements herein and in our other filings with the SEC, including those set forth under Part I, Item 1A, Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2025.

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Altimmune, Inc.

is a late clinical-stage biopharmaceutical company developing novel peptide-based therapeutics for liver and cardiometabolic diseases.

Our lead program is pemvidutide (formerly known as ALT-801), a balanced 1:1 glucagon/GLP-1 dual receptor agonist for the treatment of MASH, AUD and ALD.

We may also pursue additional indications for pemvidutide that leverage our differentiated clinical profile.

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.

Recent Business Update

On June 26, 2025, we released planned, 24-week topline efficacy results from IMPACT, a Phase 2b trial in 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 either weekly subcutaneous pemvidutide at 1.2 mg or 1.8 mg doses or placebo for 48 weeks.

In an intent-to-treat (“ITT”) analysis, in which subjects with missing biopsies were considered non-responders, the proportions of subjects achieving MASH resolution without worsening of fibrosis at 24 weeks were 58% and 52%, for pemvidutide 1.2 mg and 1.8 mg, respectively versus 20% for placebo (p< 0.0001 both doses).

The effects on fibrosis improvement without worsening of MASH in an ITT analysis were 33% and 36% for pemvidutide 1.2 mg and 1.8 mg, respectively compared with 28% for placebo (differences not statistically significant).

A supplemental AI-based analysis demonstrated statistically significant reductions in fibrosis, including 31% of subjects receiving pemvidutide 1.8 mg achieving a 60% or more reduction in fibrosis compared to 8% receiving placebo (p< 0.001).

Statistically significant changes in well-established non-invasive tests of fibrosis, including ELF score and VCTE were also observed compared

with placebo at both doses.

Together, this data suggests strong evidence of anti-fibrotic activity of pemvidutide in the MASH population.

At 24 weeks, mean weight loss in pemvidutide-treated subjects was 4.8% and 5.8% at the 1.2 mg and 1.8 mg doses, respectively, versus 0.5% in the placebo arm (p< 0.001, both doses).

The numerical values here are slightly different than originally announced as part of the topline data, but do not impact statistical significance across any of the results.

Pemvidutide also demonstrated favorable safety and tolerability, with low overall treatment discontinuation rates due to adverse events of less than 1% and 1.2% in the pemvidutide 1.2 mg and 1.8 mg groups versus 2.4% in the placebo group, an important finding given that no dose titration was used in the trial.

There were no serious adverse events related to study medication.

On March 13, 2025, we announced that we are pursuing two additional indications for our lead product candidate, pemvidutide.

The new indications are alcohol use disorder (“AUD”) and alcohol-associated liver disease (“ALD”), also known as Alcohol Liver Disease.

AUD is a chronic disease characterized by excessive drinking.

In addition to the underlying alcohol misuse by AUD patients, AUD patients have comorbidities that pose significant treatment and management challenges (including liver steatosis, obesity, hypertension and hyperlipidemia).

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.

Underwritten Public Offering

On April 24, 2026, we completed an underwritten public offering pursuant to which we raised approximately $211.2 million in net proceeds from the issuance of combination of common stock, common stock warrants and pre-funded warrants.

The common stock and pre-funded warrants were sold in combination with an accompanying common stock warrant to purchase one share of common stock (or pre-funded warrant in lieu thereof) issued for each share of common stock or pre-funded warrant sold.

The gross proceeds could increase by another $225 million if all the warrant holders exercise their common stock warrants.

Subsequent Events for additional information.

Ongoing Clinical Trials

In January 2026, we announced that the U.S.

Food and Drug Administration (“FDA”) granted Breakthrough Therapy Designation to pemvidutide for the treatment of MASH based on the data from the IMPACT Phase 2b trial at 24 weeks in which we observed statistically significant MASH resolution and positive trends in fibrosis improvement.

In December 2025, the Company announced positive 48-week data from the IMPACT trial, including statistically significant improvements observed in key non-invasive markers of fibrosis and inflammation, such as Enhanced Liver Fibrosis (ELF) and Liver Stiffness Measurement (LSM), which are strongly associated with MASH histologic changes, and noted continued reductions from 24-week timepoint.

Additional weight loss was observed from 24 weeks to 48 weeks at the 1.8 mg dose with no evidence of plateauing.

We also observed greater adherence to treatment in the pemvidutide arms, as shown by lower discontinuation rates than the placebo group which may be attributable to the favorable safety and tolerability profile of pemvidutide.

With the positive 48-week data from the IMPACT trial, FDA designation and having secured the necessary financing, we are in the start up phase of the execution of our PERFORMA Phase 3 trial in MASH.

We have aligned with the FDA following an End of Phase 2 Meeting, and submitted the final study protocol to the FDA.

Further, we received scientific advice from the European Medicines Agency and MHRA and selected a global CRO with deep experience running global MASH pivotal trials.

The global pivotal PERFORMA Phase 3 trial will test two doses of pemvidutide over an estimated duration of approximately 60 months for liver-related events supporting final approval, including an interim analysis after 52 weeks to support with biopsy based-endpoints to support an accelerated approval.

We are planning to initiate the PERFORMA Phase 3 trial in the second half of 2026.

RECLAIM, a Phase 2 trial evaluating the efficacy and safety of pemvidutide in subjects with AUD, is a randomized, placebo-controlled trial conducted across approximately 15 sites in the United States, targeting enrollment of approximately 100 subjects.

Subjects will be randomized 1:1 to receive either 2.4 mg pemvidutide or placebo weekly for 24 weeks.

The trial’s primary endpoint is a change in alcohol consumption, measured by the change from baseline in the average number of heavy drinking days per week at Week 24, with the key secondary endpoints including the proportion of subjects achieving a 2-level reduction in World Health Organization (“WHO”) risk drinking level and the absolute change from baseline in average levels of phosphatidylethanol (“PEth”), a serum biomarker of alcohol intake.

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.

Enrollment completed ahead of schedule, underscoring strong interest from patient community in a new therapeutic option for AUD.

We noted that we are on track to complete the 24-week treatment period and announce topline results in 2026.

ALD is a disease characterized by damage to the liver due to excessive and chronic alcohol use.

ALD progression (like MASH progression) begins with liver steatosis, which may lead to inflammation, fibrosis and, ultimately, to cirrhosis.

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.

The trial’s primary endpoint is a change in alcohol consumption, measured by the change from baseline in the average number of heavy drinking days per week measured at Week 24, with the key secondary endpoints including the proportion of subjects achieving a 2-level reduction in World Health Organization (“WHO”) risk drinking level and the absolute change from baseline in average levels of phosphatidylethanol (“PEth”), a serum biomarker of alcohol intake.

In 2025, the FDA granted Fast Track designation to pemvidutide for the treatment of AUD.

Enrollment was completed in November 2025, several months ahead of schedule, and we are on track to complete the 24-week treatment period and announce topline results in the third quarter 2026.

RESTORE, a Phase 2 trial evaluating the efficacy and safety of pemvidutide in subjects with ALD, is a randomized, placebo-controlled trial enrolling approximately 100 patients across 34 sites in the United States.

Subjects will be randomized 1:1 to receive either 2.4mg pemvidutide or placebo weekly for 48 weeks.

The trial’s primary endpoint is the change from baseline in Liver Stiffness Measurement (“LSM”) by vibration-controlled transient elastography (“VCTE”) at Week 24.

Key secondary endpoints include the change from baseline in LSM by VCTE at Week 48, changes in Enhanced Liver Fibrosis (“ELF”) score at Weeks 24 and 48, and changes in alcohol consumption and body weight at the same time points.

Main secondary endpoints include the change from baseline in LSM by VCTE at Week 48, changes in ELF score at Weeks 24 and 48, and changes in alcohol consumption and body weight at the same time points.

We expect to complete enrollment in the RESTORE trial in the third quarter of 2026.

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.

Government Shutdown

On October 1, 2025, the U.S.

federal government entered a shutdown suspending services deemed non-essential as a result of the failure by Congress to enact regular appropriations for the 2026 fiscal year.

If the shutdown continues for a prolonged period of time, it could result in significant delays in the SEC’s and FDA's ability to timely review and process any submissions we have filed or may file or cause other regulatory delays, which could have a material adverse effect on our business.

have been causing uncertainties in the global markets.

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 our 2025 Annual Report on Form 10-K.

Conflict in Middle East

We are closely monitoring the impact of the ongoing military conflict in the Middle East, including the recent conflict involving the U.S., Israel and Iran, on our business as the conflict has caused increased economic uncertainty and operational complexity globally.

While we have no direct exposure to the Middle East, and do not at the moment believe the situation will have a material impact on our operating results, we are monitoring any broader economic impact from the situation.

Should the conflict continue or escalate, it could have a significant negative effect on the global economy or on our operations, including continued inflationary pressures on raw materials, oil and energy prices and clinical trial costs, supply chain and logistics disruptions, volatility in foreign exchange rates and interest rates and heightened cybersecurity threats.

Results of Operations

Comparison of the three months ended September 30, 2025 and 2024

The following table summarizes our results of operations for the three months ended September 30, 2025 and 2024 (in thousands):

Three Months Ended September 30,

Increase (Decrease)

Operating expenses:

Research and development

General and administrative

Total operating expenses

Loss from operations

Other income (expense):

Interest expense

Interest income

Other income (expense), net

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.

Research and development expenses

Research and development expenses consisted primarily of expenses related to product candidate development.

Research and development expenses decreased by $4.8 million, or 24%, for the three months ended September 30, 2025, as compared to the same period ended September 30, 2024:

Three Months Ended September 30,

(in thousands)

Increase (Decrease)

Other pemvidutide expenses

Total pemvidutide expenses

Non-project costs

Total research and development expenses

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.

The decrease in other pemvidutide expenses was primarily due to a $1.2 million decrease in manufacturing expenses.

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.

The decrease in non-project costs were primarily due to a $0.8 million initial cost for additional research and discovery projects during 2024 which were not pursued in 2025 and a $0.3 million reduction in overhead costs.

General and administrative expenses

General and administrative expenses increased by $0.9 million, or 19%, for the three months ended September 30, 2025, as compared to the three months ended September 30, 2024, primarily due to a $0.7 million increase in stock compensation and other labor-related expenses and a $0.4 million increase in expenses for professional services.

Total other income (expense), net

Total other income (expense), net decreased by $0.1 million, or 4%, for the three months ended September 30, 2025, as compared to the three months ended September 30, 2024.

Comparison of the nine months ended September 30, 2025 and 2024

The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024 (in thousands):

Nine Months Ended September 30,

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

Three Months Ended March 31,

Increase (Decrease)

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Income tax expense (benefit)

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.

*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 consisted primarily of expenses related to product candidate development.

Research and development expenses decreased by $14.4 million, or 23%, for the nine months ended September 30, 2025, as compared to the same period ended September 30, 2024:

Nine Months Ended September 30,

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

Three Months Ended March 31,

(in thousands)

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Non-project costs

Stock compensation

Shared service and infrastructure

Total research and development expenses

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.

The decrease in other pemvidutide expenses was primarily due to a $4.5 million decrease in manufacturing expenses.

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.

The decrease in non-project costs were primarily due to a $1.3 million initial cost for additional research and discovery projects during 2024 which were not pursued in 2025 and a $0.3 million reduction in overhead costs.

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

The increase in research and development expenses was due primarily to the ongoing ALD and AUD trials as well as the startup costs for PERFORMA Phase 3 trial in MASH, partially offset by the decrease in expenses related to completion of the IMPACT Phase 2b trial in MASH, which was ongoing in the first three months of 2025.

General and administrative expenses

General and administrative expenses increased by $1.7 million, or 11%, for the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024, primarily due to a $1.2 million increase in expenses for professional services and $0.7 million increase in stock compensation and other labor-related expenses.

General and administrative expenses increased by $2.1 million, or 34%, for the three months ended March 31, 2026, as compared to the three months ended March 31, 2025.

The increase is due primarily to a $1.3 million increase in compensation expense, including $0.6 million in severance costs for one of our former executive officers and a $0.6 million increase in professional service fees.

Total other income (expense), net

Total other income (expense), net decreased by $2.2 million, or 35%, for the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024.

The net decrease was primarily due to a $1.4 million decrease in interest income earned on our cash equivalents and short-term investments and a $0.8 million increase in interest expense related to our Term Loan.

Income tax expense (benefit)

During the nine months ended September 30, 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 of 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 nine months ended September 30, 2025 and 2024.

Total other income (expense), net increased by $0.1 million, or 8%, for the three months ended March 31, 2026, as compared to the three months ended March 31, 2025.

The net increase is primarily due to a $1.4 million increase in interest income earned on our cash equivalents and short-term investments, partially offset by a $1.1 million increase in interest expense on our Term Loan.

Liquidity and Capital Resources

Our primary sources of cash during the nine months ended September 30, 2025 were from equity transactions, debt, interest 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 $210.8 million as of September 30, 2025.

We believe, based on the operating cash requirements and capital expenditures expected for 2025 and 2026, our cash on hand as of September 30, 2025, together with expected cash receipts from equity transactions, are sufficient to fund operations for at least a twelve-month period from the issuance date of our September 30, 2025 consolidated financial statements.

Our primary sources of cash during the three months ended March 31, 2026, were from equity transactions, interest 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 $331.6 million as of March 31, 2026.

We believe, based on the operating cash requirements and capital expenditures expected for 2026 and 2027, our cash on hand as of March 31, 2026, together with expected cash receipts from equity transactions finalized after March 31, 2026, are sufficient to fund operations for at least a twelve-month period from the issuance date of our March 31, 2026 consolidated financial statements.

We have not generated any revenues from the sale of any products to date, and there is no assurance of any future revenues from product sales.

We have incurred significant losses since we commenced operations.

As of September 30, 2025, we had an accumulated deficit of $622.1 million.

As of March 31, 2026,

we had an accumulated deficit of $672.0 million.

In addition, we have not generated positive cash flows from operations.

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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.

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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 April 22, 2026, we filed a registration statement on Form S-3MEF which was declared effective immediately.

This shelf registration allowed us to increase the aggregate amount under the November 2025 Shelf by an additional $65.0 million.

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

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.

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The 2023 Shelf expired on February 27, 2025.

At-the-Market Offerings

On February 27, 2025, we entered an Equity Distribution Agreement (the “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 sale agents from the 2025 Shelf.

During the nine months ended September 30, 2025, we have sold 18,524,709 shares of common stock under the 2025 Agreement resulting in approximately $81.9 million in net proceeds, and as of September 30, 2025, $65.4 million remained available to be sold under the 2025 Agreement.

ATM 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 ATM offerings program under which we may offer and sell shares of our common stock having an aggregate offering price of up to $200.0 million through the sales agent from the February 2025 Shelf.

Since inception through March 31, 2026, we raised approximately $34.2 million in net proceeds, with $165.3 million remaining available to be sold under the November 2025 Agreement.

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

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

During the nine months ended September 30, 2025, we have sold 4,467,866 shares of common stock under the 2023 Agreement, resulting in approximately $30.2 million in net proceeds.

Since inception through the expiration of the 2023 Agreement in February 2025, we raised approximately $126.8 million in net proceeds through the issuance of 26,129,903 shares of our common stock.

As of September 30, 2025, there were no remaining shares available under the 2023 Agreement as the 2023 Agreement was terminated.

The following table provides information regarding our cash flows for the nine months ended September 30, 2025 and 2024:

Nine Months Ended September 30,

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

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

January 2026 RDO

On January 27, 2026, we 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 our common stock and 4,647,534 pre-funded warrants for net proceeds of approximately $70.3 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.

April 2026 Offering

On April 22, 2026, we entered into an underwriting agreement with certain underwriters pursuant to which we offered and sold securities consisting of (i) 64,250,000 shares of our common stock and accompanying common stock warrants to purchase an aggregate of 64,250,000 shares of common stock (or pre-funded warrants in lieu thereof) and (ii) in lieu of common stock, to certain investors that so choose, pre-funded warrants to purchase an aggregate of up to 10,750,000 shares of its common stock and accompanying common stock warrants to purchase an aggregate of 10,750,000 shares of common stock (or pre-funded warrants in lieu thereof), at an exercise price of $0.001 per pre-funded warrant.

The accompanying common stock warrant has an exercise price of $3.00 per share and is immediately exercisable from the date of issuance.

The combined offering price of each share of common stock and accompany common stock warrant is $3.00.

The combined offering price of each pre-funded warrant and accompanying common stock warrant is $2.999.

The net proceeds of the April 2026 Offering were approximately $211.2 million, after deducting the underwriting discount and estimated offering expenses.

If all of the common stock warrants sold in the April 2026 Offering were to be exercised in cash at their exercise price, we would receive additional gross proceeds of $225 million.

All shares of common stock, pre-funded warrants and common stock warrants offered and sold in the April 2026 Offering were issued pursuant to the February 2025 Shelf, the November 2025 Shelf and a related registration statement that was filed with the SEC on April 22, 2026 pursuant to Rule 462(b) under the Securities Act of 1933, as amended, and became automatically effective upon filing as permitted under Rule 429.

The following table provides information regarding our cash flows for the three months ended March 31, 2026 and 2025:

Three Months Ended March 31,

(in thousands)

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Financing activities

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

Net increase in cash and cash equivalents and restricted cash

Operating Activities

Net cash used in operating activities was $48.1 million for the nine months ended September 30, 2025 compared to $61.6 million during the nine months ended September 30, 2024.

Net cash used in operating activities was $20.9 million for the three months ended March 31, 2026, compared to $16.8 million during the three months ended March 31, 2025.

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 decrease in cash used in operations of $13.5 million year over year is due to changes in working capital accounts of $1.1 million and a decrease in net loss as adjusted for non-cash items of $12.4 million.

The increase in cash used in operations of $4.1 million year over year is due to changes in working capital accounts of $2.1 million and an increase in net loss as adjusted for non-cash items of $2.0 million.

Investing Activities

Net cash used in investing activities was $53.3 million for the nine months ended September 30, 2025 compared to $42.0 million net cash used in investing activities during the nine months ended September 30, 2024.

The net cash used in investing activities during the nine months ended September 30, 2025 was primarily due to a $196.9 million purchase of short-term investments, partially offset by a $143.6 million in proceeds from sale and maturities of short-term investments.

The net cash used in investing activities during the nine months ended September 30, 2024 was primarily due to a $102.5 million purchase of short-term investments, partially offset by a $60.5 million in proceeds from sale and maturities of short-term investments.

Net cash used in investing activities was $3.7 million, for the three months ended March 31, 2026 compared to $5.1 million net cash used in investing activities during the three months ended March 31, 2025.

The cash used in investing activities during the three months ended March 31, 2026 was primarily due to the purchase of $43.3 million of short-term investments, partially offset by $39.6 million in proceeds from sale and maturities of short-term investments.

The cash used in investing activities during the three months ended March 31, 2025, was primarily due to a $43.1 million purchase of short-term investments, partially offset by $38.0 million in proceeds from sale and maturities of short-term investments.

Financing Activities

Net cash provided by financing activities was $125.7 million during the nine months ended September 30, 2025 compared to a negligible amount of cash used in financing activities during the nine months ended September 30, 2024.

The net cash provided by financing activities during the nine months ended September 30, 2025 was primarily the result of the receipt of $111.8 million in net proceeds from the issuance of common stock from our at-the-market offerings program, $14.3 million in net proceeds from the term loan, and $0.3 million in proceeds from the ESPP, partially offset by $0.7 million net payments for tax withholding obligations related to share-based compensation.

The net cash used in financing activities during the nine months ended September 30, 2024 was primarily due to $0.8 million net payments for tax withholding obligations related to share-based compensation, partially offset by $0.3 million in proceeds from the ESPP, $0.3 million in proceeds from exercise of stock options and $0.2 million in proceeds from exercise of stock warrants.

Current Resources

We have financed our operations to date principally through our equity offerings and proceeds from issuances of our common stock.

As of September 30, 2025, we had $210.8 million of cash, cash equivalents, restricted cash and short-term investments.

Accordingly, management believes that we have sufficient capital to fund our plan of operations for at least a twelve-month period from the issuance date of our September 30, 2025 financial statements.

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, and monetization of our existing programs through partnership arrangements or sales to third parties.

Net cash provided by financing activities was $78.5 million during the three months ended March 31, 2026, compared to $34.1 million net cash provided by financing activities during the three months ended March 31, 2025.

The net cash provided by financing activities during the three months ended March 31, 2026, was primarily the result of the receipt of $70.3 million in net proceeds from the January 2026 RDO, $8.7 million in proceeds from the issuance of common stock from our ATM offerings program, net of deferred offering costs, $0.2 million in proceeds from proceeds from the sale of shares under the ESPP, partially offset by $0.7 million net payment for tax withholding obligations related to share-based compensation.

The net cash provided by financing activities during the three months ended March 31, 2025, was primarily the result of the receipt of $34.6 million in proceeds from the issuance of common stock from our ATM offerings program and $0.2 million proceeds from the sale of shares under the ESPP, partially offset by $0.7 million payment for tax withholding obligations related to share-based compensation.

Capital Resources

We have financed our operations to date principally through our equity offerings, debt and proceeds from issuances of our preferred stock, common stock and warrants.

As of March 31, 2026, we had $97.6 million of cash, cash equivalents and restricted cash and $233.9 million of short-term investments.

Accordingly, management believes that we have sufficient capital to fund our plan of operations for at least a twelve-month period from the issuance date of our March 31, 2026 consolidated financial statements.

In order to address our long-term capital needs, including our planned clinical trials, in April 2026, we raised approximately $211.2 million in net proceeds from the April 2026 Offering.

If all of the common stock warrants issued in the April 2026 Offering are exercised, we would receive an additional $225 million in gross proceeds.

Critical Accounting Estimates

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We base our estimates and judgments on historical experience, knowledge of current conditions, and expectations of what could occur in the future given available information.

There have been no changes in our critical accounting policies and significant judgment and estimates as disclosed in our Annual Report on Form 10-K for the year ended December 31, 2024.

Stock-based Compensation

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.

The application of this valuation model involves assumptions that are highly subjective, judgmental and sensitive in the determination of compensation cost.

Having achieved sufficient historical data on our own stock, effective January 1, 2026, the expected stock price volatility for stock option awards is based on the historical volatility of our stock price volatility.

The average expected life of stock options was determined according to the “simplified method” as described in SAB 107, which is the midpoint between the vesting date and the end of the contractual term.

The risk-free interest rate was determined by reference to implied yields available from U.S.

Treasury securities with a remaining term equal to the expected life assumed at the date of grant.

We have not paid and do not anticipate paying cash dividends.

Therefore, the expected dividend rate is assumed to be 0%.

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

Quantitative and Qualitative Disclosures about Market Risk

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What changed 10-Q

Item 2. Management’s Discussion and Analysis