Altimmune Announces Fourth Quarter and Full-year 2025 Financial Results and Business Updates
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
Webcast to be held today,
“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
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 OfficerMr. Durso , who joined the Company’s Board of Directors inFebruary 2025 and was appointed Chairman inAugust 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 atIntercept Pharmaceuticals , where he served as Chief Executive Officer until its acquisition byAlfasigma . 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 withAlyeska 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
Financial Results for the Three Months Ended
- Altimmune reported cash, cash equivalents and short-term investments totaling
$274 million as ofDecember 31, 2025 , an increase of approximately 107% as compared to$132 million atDecember 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
- As of
- Research and development (R&D) expenses were
$18.4 million for the three months endedDecember 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 endedDecember 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 endedDecember 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 endedDecember 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
- R&D expenses were
$66.4 million for the year endedDecember 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 endedDecember 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 endedDecember 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 endedDecember 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: | |
| 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
Investor Contact:
lroth@burnsmc.com
Media Contact:
Real Chemistry
altimmune@realchemistry.com
| ALTIMMUNE, INC. CONSOLIDATED BALANCE SHEETS (In thousands, except share and per-share amounts) |
||||||||
| 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, |
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 | |||||||||||||||
| 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 | ||||||||||||
Source: Altimmune, Inc
