Altimmune Announces Fourth Quarter and Full-year 2025 Financial Results and Business Updates
MWN-AI** Summary
Altimmune, Inc. (Nasdaq: ALT), a biopharmaceutical company focused on serious liver diseases, reported its financial results for the fourth quarter and full year ending December 31, 2025, along with important corporate updates. As of December 31, 2025, Altimmune held $274 million in cash, cash equivalents, and short-term investments, significantly bolstered by a $75 million direct offering in January 2026. CEO Jerry Durso highlighted the potential of pemvidutide, a dual-action therapy targeting metabolic dysfunction-associated steatohepatitis (MASH), which was recently granted FDA Breakthrough Therapy Designation.
In 2025, Altimmune made substantial advancements in its research programs. Positive results were reported from the 48-week IMPACT Phase 2b trial of pemvidutide in MASH, showing meaningful improvements in non-invasive markers of liver disease. The upcoming Phase 3 clinical trial for MASH is set for 2026, aiming to evaluate multiple doses over 52 weeks with biopsy-based endpoints. Meanwhile, topline data from the RECLAIM Phase 2 trial for alcohol use disorder (AUD) is anticipated in the third quarter of 2026.
The company also initiated the RESTORE Phase 2 trial assessing pemvidutide for alcohol-associated liver disease, building on the momentum from the successful completion of trial enrollments ahead of schedule. The reporting period saw R&D expenses decrease to $66.4 million for the year from $82.2 million the previous year, attributed to the timing of clinical costs. In contrast, general and administrative expenses rose due to executive transitions and increased operational costs. Overall, Altimmune's executive changes and robust financial position set the stage for pivotal 2026 milestones in pemvidutide's developmental journey.
MWN-AI** Analysis
Altimmune, Inc. (Nazdaq: ALT) recently reported its fourth-quarter and full-year financial results for 2025, showcasing significant advancements in its pipeline, specifically regarding pemvidutide, a novel dual-action therapy aimed at treating metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD), and alcohol-associated liver disease (ALD). The firm is preparing to initiate a Phase 3 trial for pemvidutide in MASH, as it has been granted Breakthrough Therapy Designation by the FDA based on promising Phase 2b trial data.
As of December 31, 2025, Altimmune holds a robust cash position of $274 million, bolstered by a recent $75 million direct offering in January 2026. This financial stability is crucial as the company advances into Phase 3 trials, expectantly stabilizing its operational framework against the backdrop of ongoing clinical development costs, which decreased in 2025 compared to 2024.
Investors should closely monitor upcoming milestones, notably the topline data from the Phase 2 RECLAIM trial of pemvidutide in AUD, expected in Q3 2026. Strong performance in these trials could potentially spike share prices, reflecting investor sentiment around pemvidutide's efficacy in addressing significant unmet medical needs.
While the increasing R&D and G&A expenditures highlight an aggressive growth model, the slightly reduced net loss per share year-over-year suggests improved overall efficiency. The ongoing focus on enhancing the safety and efficacy profiles of pemvidutide, coupled with strategic investments in clinical pipeline development, positions Altimmune favorably in the biopharmaceutical landscape.
Given the promising data and advancements from Altimmune, along with its substantial financial backing, the stock presents an intriguing opportunity for both speculative and long-term investors keen on the biopharma sector. However, investors should remain vigilant of potential risks associated with clinical trials and regulatory pathways.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
Initiation of Phase 3 MASH trial planned for 2026
Pemvidutide granted FDA Breakthrough Therapy Designation in MASH
Topline data from RECLAIM Phase 2 trial of pemvidutide in alcohol use disorder (AUD) expected in third quarter 2026
Cash, cash equivalents and short-term investments of $274 million as of December 31, 2025; Balance sheet further strengthened through $75 million registered direct offering in January 2026
Webcast to be held today, March 5, 2026, at 8:30 a.m. ET
GAITHERSBURG, Md., March 05, 2026 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing pemvidutide to address serious liver diseases, today announced financial results for the fourth quarter and full year ended December 31, 2025, and provided a corporate update.
“In pemvidutide, we have a unique and differentiated compound with the potential to address critical unmet needs of patients with serious liver diseases such as MASH. We are committed to taking the necessary steps to realize its value for all of our stakeholders and have significantly progressed our efforts to strengthen our financial and operational foundation,” said Jerry Durso, President and Chief Executive Officer of Altimmune. “We remain focused on ensuring that we have the means and the capabilities to successfully execute Phase 3 development in MASH and capture the significant opportunities ahead of us. We have a number of important inflection points in 2026, most notably the upcoming initiation of our Phase 3 trial of pemvidutide in MASH, for which we are actively finalizing the study plan. Finally, we look forward to the topline data from our RECLAIM Phase 2 trial of pemvidutide in AUD, which we expect to release in the third quarter.”
Recent Highlights and Anticipated Milestones
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
- Positive 48-week data from IMPACT Phase 2b trial reported in December 2025
- Statistically significant improvements observed in key non-invasive markers of fibrosis and inflammation, such as Enhanced Liver Fibrosis (ELF) and Liver Stiffness Measurement (LSM), with continued reductions from 24-week timepoint
- These markers are strongly associated with MASH histologic changes
- These results build upon the statistically significant MASH resolution and positive trends in fibrosis improvement observed at 24 weeks
- Additional weight loss from 24 to 48 weeks at the 1.8 mg dose with no evidence of plateauing
- Greater adherence to treatment in pemvidutide arms, as shown by lower discontinuation rate than placebo group
- Adherence likely attributable to favorable safety and tolerability profile of pemvidutide
- Statistically significant improvements observed in key non-invasive markers of fibrosis and inflammation, such as Enhanced Liver Fibrosis (ELF) and Liver Stiffness Measurement (LSM), with continued reductions from 24-week timepoint
- Breakthrough Therapy Designation granted by FDA
- Breakthrough Therapy Designation was granted based on 24-week data from IMPACT trial
- This designation is awarded to therapies designed to treat serious or life- threatening conditions that have shown preliminary clinical evidence indicating the potential for substantial improvement over available therapies on a clinically significant endpoint
- Successful End-of-Phase 2 Meeting with FDA
- Alignment on Phase 3 registrational trial design confirmed following receipt of meeting minutes
- Global Phase 3 trial expected to evaluate multiple pemvidutide doses over a 52-week treatment period with biopsy-based endpoints to support potential accelerated approval
- Company has submitted request for scientific advice to European regulators
Alcohol Use Disorder (AUD)
- Topline data from RECLAIM Phase 2 trial of pemvidutide in AUD expected in third quarter 2026
- The RECLAIM trial is evaluating the safety and efficacy of pemvidutide versus placebo in approximately 100 patients with AUD over a 24-week treatment period
- Enrollment was completed in November 2025, several months ahead of schedule, signaling significant interest from patients and providers in potential new AUD therapies
Alcohol-associated Liver Disease (ALD)
- RESTORE Phase 2 trial of pemvidutide in ALD continuing to enroll
- The RESTORE trial is a 48-week study evaluating the safety and efficacy of pemvidutide versus placebo in approximately 100 patients with ALD
- The RESTORE trial is a 48-week study evaluating the safety and efficacy of pemvidutide versus placebo in approximately 100 patients with ALD
Corporate Updates
- Appointed Jerry Durso as Chief Executive Officer
- Mr. Durso, who joined the Company’s Board of Directors in February 2025 and was appointed Chairman in August 2025, is an accomplished life sciences executive with more than 30 years of leadership experience in corporate and commercial strategy, business development and operations. His accomplishments include the development of a successful rare liver disease franchise at Intercept Pharmaceuticals, where he served as Chief Executive Officer until its acquisition by Alfasigma. Previously, he oversaw multiple blockbuster franchises during more than 20 years in senior leadership positions at Sanofi
- Strengthened balance sheet
- In January 2026, the Company completed a registered direct offering of common stock and pre-funded warrants with Alyeska Investment Group, resulting in gross proceeds of $75.0 million, and raised an additional $8.0 million via the At-the-Market (ATM) facility
- In January 2026, the Company completed a registered direct offering of common stock and pre-funded warrants with Alyeska Investment Group, resulting in gross proceeds of $75.0 million, and raised an additional $8.0 million via the At-the-Market (ATM) facility
Financial Results for the Three Months Ended December 31, 2025
- Altimmune reported cash, cash equivalents and short-term investments totaling $274 million as of December 31, 2025, an increase of approximately 107% as compared to $132 million at December 31, 2024
- As of February 28, 2026, the Company had approximately $340 million of cash and cash equivalents, reflecting the proceeds from the $75 million registered direct offering and $8 million from the sale of stock under the Company's ATM facility
- Research and development (R&D) expenses were $18.4 million for the three months ended December 31, 2025, compared to $19.8 million in the same period in 2024, with the decrease related to fluctuations in timing of Clinical Research Organization (CRO) related costs. R&D expenses for the quarter ended December 31, 2025, included $12.8 million in direct costs related to pemvidutide development activities
- General and administrative (G&A) expenses were $10.5 million and $5.1 million for the three months ended December 31, 2025 and 2024, respectively. The increase was primarily attributable to additional professional fees and compensation expenses, including a one-time stock compensation and payroll-related expense of approximately $2.6 million in the fourth quarter of 2025
- Interest income was $2.4 million for the three months ended December 31, 2025
- Net loss for the three months ended December 31, 2025, was $27.4 million, or $0.27 net loss per share, compared to a net loss of $23.2 million, or $0.33 net loss per share, in the same period in 2024
Financial Results for the Year Ended December 31, 2025
- R&D expenses were $66.4 million for the year ended December 31, 2025, compared to $82.2 million in the same period in 2024, with the decrease primarily related to the timing of CRO development costs. The R&D expenses for the year ended December 31, 2025, included $42.4 million in direct costs related to pemvidutide development activities
- G&A expenses were $28.1 million and $21.0 million for the 12 months ended December 31, 2025, and 2024, respectively. The G&A increase was primarily attributable to a one-time executive transition cost, as well as increases in professional fees and stock compensation and other labor-related expenses
- Interest income was $7.5 million for the year ended December 31, 2025, compared to $8.1 million in the same period in 2024
- Net loss for the three months ended December 31, 2025 was $88.1 million, or $1.00 net loss per share, compared to a net loss of $95.1 million, or $1.34 net loss per share, in the same period in 2024
| Conference Call Information: | |
| Date: | March 5, 2026 |
| Time: | 8:30 a.m. Eastern Time |
| Webcast: | To listen, the conference call will be webcast live on Altimmune’s Investor Relations website at https://ir.altimmune.com/investors. |
| Dial-in: | To participate or dial-in, register here to receive the dial-in numbers and unique PIN to access the call. |
Following the conclusion of the call, the webcast will be available for replay on the Investor Relations (IR) page of the Company’s website at www.altimmune.com. The Company has used, and intends to continue to use, the IR portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD.
About Pemvidutide
Pemvidutide is a novel, investigational peptide with balanced 1:1 glucagon/GLP-1 dual receptor agonist activity, in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD) and alcohol-associated liver disease (ALD). The activation of glucagon receptors results in direct effects on the liver, including reductions in liver fat, inflammation and fibrosis, while GLP-1 receptors mediate metabolic effects such as appetite suppression and weight loss.
The FDA granted Fast Track designations to pemvidutide for the treatment of MASH and AUD, as well as Breakthrough Therapy Designation for MASH. In December 2025, the Company announced 48-week data from the IMPACT Phase 2b trial in MASH. The Phase 2 RECLAIM trial in AUD and RESTORE trial in ALD were initiated in May 2025 and July 2025, respectively, and are currently ongoing.
About Altimmune
Altimmune is a late clinical-stage biopharmaceutical company developing therapies for patients with serious liver diseases. The Company’s lead candidate, pemvidutide, is a unique dual-action therapy targeting both glucagon and GLP-1 receptors in a balanced 1:1 ratio in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD) and alcohol-associated liver disease (ALD). For more information, please visit www.altimmune.com.
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Forward-Looking Statement
Any statements made in this press release related to the development or commercialization of pemvidutide, an investigational product candidate, and other business, regulatory and financial matters including without limitation, clinical trial study design, status, correspondence, results and data, including the ongoing RECLAIM and RESTORE trials, the timing of key milestones for the Company’s clinical programs, future plans or expectations for pemvidutide for the treatment of MASH, AUD and ALD, the potential benefits of Fast Track and Breakthrough Therapy Designations, including potential regulatory timeline and approval benefits, the Company’s financial position, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates, financial results, and the impact of the changes to our leadership and governance structure, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to Altimmune, Inc. may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including risks relating to: delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, enrollment, adverse effects on healthcare systems and disruption of the global economy; the reliability of the results of studies relating to human safety and possible adverse effects resulting from the administration of the Company's product candidates; the Company's ability to manufacture clinical trial materials on the timelines anticipated; and the success of future product advancements, including the success of future clinical trials. Further information on the factors and risks that could affect the Company's business, financial conditions and results of operations are contained in the Company's filings with the U.S. Securities and Exchange Commission, including under the heading "Risk Factors" in the Company's most recent annual report on Form 10-K, quarterly report on Form 10-Q and the Company’s other filings with the SEC, which are available at www.sec.gov.
Investor Contact:
Lee Roth
Burns McClellan
lroth@burnsmc.com
Media Contact:
Real Chemistry
altimmune@realchemistry.com
| ALTIMMUNE, INC. CONSOLIDATED BALANCE SHEETS (In thousands, except share and per-share amounts) | ||||||||
| December 31, | ||||||||
| 2025 | 2024 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 43,760 | $ | 36,926 | ||||
| Restricted cash | 42 | 42 | ||||||
| Total cash, cash equivalents and restricted cash | 43,802 | 36,968 | ||||||
| Short-term investments | 229,696 | 94,965 | ||||||
| Accounts and other receivables | 1,219 | 544 | ||||||
| Income tax and R&D incentive receivables | 518 | 2,573 | ||||||
| Prepaid expenses and other current assets | 2,957 | 2,204 | ||||||
| Total current assets | 278,192 | 137,254 | ||||||
| Property and equipment, net | 312 | 413 | ||||||
| Other assets | 1,425 | 1,639 | ||||||
| Total assets | $ | 279,929 | $ | 139,306 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,717 | $ | 211 | ||||
| Accrued expenses and other current liabilities | 12,280 | 10,257 | ||||||
| Total current liabilities | 14,997 | 10,468 | ||||||
| Term loan, noncurrent | 34,287 | — | ||||||
| Other noncurrent liabilities | 5,753 | 5,330 | ||||||
| Total liabilities | 55,037 | 15,798 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Common stock, $0.0001 par value; 200,000,000 shares authorized; 110,882,735 and 72,352,701 shares issued and outstanding as of December 31, 2025 and 2024, respectively | 11 | 7 | ||||||
| Additional paid-in capital | 879,292 | 689,864 | ||||||
| Accumulated deficit | (649,483 | ) | (561,390 | ) | ||||
| Accumulated other comprehensive loss, net | (4,928 | ) | (4,973 | ) | ||||
| Total stockholders’ equity | 224,892 | 123,508 | ||||||
| Total liabilities and stockholders’ equity | $ | 279,929 | $ | 139,306 | ||||
| ALTIMMUNE, INC. CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands, except share and per-share amounts) | ||||||||||||||||
| Three Months Ended | Year Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Revenues | $ | 26 | $ | 5 | $ | 41 | $ | 20 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 18,409 | 19,781 | 66,432 | 82,226 | ||||||||||||
| General and administrative | 10,510 | 5,090 | 28,098 | 20,966 | ||||||||||||
| Total operating expenses | 28,919 | 24,871 | 94,530 | 103,192 | ||||||||||||
| Loss from operations | (28,893 | ) | (24,866 | ) | (94,489 | ) | (103,172 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest expense | (876 | ) | (1 | ) | (1,636 | ) | (9 | ) | ||||||||
| Interest income | 2,438 | 1,569 | 7,541 | 8,074 | ||||||||||||
| Other income (expense), net | (27 | ) | 118 | (190 | ) | 48 | ||||||||||
| Total other income (expense), net | 1,535 | 1,686 | 5,715 | 8,113 | ||||||||||||
| Net loss before income taxes | (27,358 | ) | (23,180 | ) | (88,774 | ) | (95,059 | ) | ||||||||
| Income tax expense (benefit) | — | — | (681 | ) | — | |||||||||||
| Net loss | (27,358 | ) | (23,180 | ) | (88,093 | ) | (95,059 | ) | ||||||||
| Other comprehensive income — unrealized gain (loss) on short-term investments | 88 | (128 | ) | 45 | 31 | |||||||||||
| Comprehensive loss | $ | (27,270 | ) | $ | (23,308 | ) | $ | (88,048 | ) | $ | (95,028 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.27 | ) | $ | (0.33 | ) | $ | (1.00 | ) | $ | (1.34 | ) | ||||
| Weighted-average common shares outstanding, basic and diluted | 100,613,438 | 71,260,875 | 88,104,132 | 71,003,399 |
FAQ**
What specific endpoints will Altimmune Inc. ALT be evaluating in the Phase 3 trial for pemvidutide in MASH to support potential accelerated approval based on the study design confirmed in the End-of-Phase 2 meeting with the FDA?
How does Altimmune Inc. ALT plan to manage the financial implications of the upcoming Phase 3 MASH trial, considering the cash position of approximately $340 million as of February 2026, especially in relation to the costs of trial execution?
Given the Breakthrough Therapy Designation by the FDA for pemvidutide in MASH, what are Altimmune Inc. ALT's expectations regarding the potential timeline for regulatory approval and market introduction of this therapeutic option?
What learnings from the ongoing RECLAIM Phase 2 trial in AUD does Altimmune Inc. ALT anticipate will influence the design and execution of the Phase 3 trial for pemvidutide in MASH, especially regarding patient recruitment and outcomes?
**MWN-AI FAQ is based on asking OpenAI questions about Altimmune Inc. (NASDAQ: ALT).
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