AI Earnings Predictions for Altimmune Inc. (ALT)

EX-99.1

2 alt-20260812xex99d1.htm

EX-99.1

Exhibit 99.1

Altimmune Announces Second Quarter 2026 Financial Results and Business Update

​

Initiated global PERFORMA Phase 3 trial in MASH

Reported positive topline data from RECLAIM Phase 2 trial in AUD

Completed patient enrollment in RESTORE Phase 2 trial in ALD

$519 million in cash, cash equivalents and investments as of June 30, 2026

Webcast to be held today at 8:30 a.m. ET

​

GAITHERSBURG, MD – August 12, 2026 – Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing pemvidutide to address serious liver diseases, today announced financial results for the second quarter ended June 30, 2026, and provided a corporate update.

“We have achieved several important milestones as we continue to successfully execute our strategy, including the initiation of the PERFORMA Phase 3 MASH trial and positive topline data from the RECLAIM Phase 2 AUD trial. The team remains focused on advancing our differentiated pemvidutide franchise in both MASH and AUD, each an area of unmet need with substantial future sales potential,” said Jerry Durso, Chief Executive Officer and Chairman of the Board of Altimmune. “We are also pleased to announce completion of enrollment in the RESTORE Phase 2 ALD trial. Our momentum positions Altimmune to deliver on our goals of bringing pemvidutide to patients with serious liver diseases and creating value for shareholders.”

​

Key Highlights and Anticipated Milestones

​

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

●Pemvidutide was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) based on 24-week data from the IMPACT Phase 2b trial

●In August 2026, the Company announced the initiation of the global PERFORMA Phase 3 MASH trial, with 52-week data readout anticipated in 2029

oThe PERFORMA trial is a Phase 3, Global, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Clinical Outcomes of Pemvidutide in Subjects with MASH

​

Alcohol Use Disorder (AUD)

●In July 2026, the Company reported positive topline results from the RECLAIM Phase 2 trial of pemvidutide in AUD

oThe RECLAIM trial evaluated the safety and efficacy of pemvidutide versus placebo in 100 patients with AUD over a 24-week treatment period

oPemvidutide achieved a statistically significant and clinically meaningful reduction in heavy drinking days, the primary endpoint of the trial

oImportant secondary endpoints were also met, including a 2-level reduction in WHO-risk drinking levels and zero heavy drinking days, both recognized by the FDA as registrational endpoints

oA generally favorable safety and tolerability profile was observed in the trial

oThe Company plans to request an End-of-Phase 2 meeting with the FDA and engage with the European regulatory agencies to discuss a path forward in AUD

oThe FDA granted Fast Track designation to pemvidutide for the treatment of AUD

​

Alcohol-associated Liver Disease (ALD)

●In July 2026, the Company completed patient enrollment in the RESTORE Phase 2 trial of pemvidutide in ALD

oThe RESTORE trial is a 48-week study evaluating the safety and efficacy of pemvidutide versus placebo in approximately 120 patients with liver disease due to excessive alcohol consumption

oThe trial enrolled patients with ALD and a history of chronic and heavy drinking at baseline

oTo support future regulatory discussions, the Company has amended the trial protocol to more fully evaluate the liver benefits pemvidutide may provide after one year of treatment in the ALD population

oThe primary endpoint, change from baseline in Liver Stiffness Measurement (LSM), will now be assessed hierarchically at Week 48 and then at Week 24

oThe secondary endpoints include changes in Enhanced Liver Fibrosis (ELF) score, alcohol consumption and body weight

oThe Company expects to report topline data in the second half of 2027

​

Corporate Updates

●In April 2026, the Company completed an oversubscribed public offering of common stock, pre-funded warrants, and stock warrants, resulting in gross proceeds of $225.0 million

●In June 2026, the Company announced plans to relocate its corporate headquarters to Morristown, New Jersey later in 2026

​

​

​

​

Financial Results for the Three Months Ended June 30, 2026

●Altimmune reported cash, cash equivalents and investments totaling $519 million as of June 30, 2026

●Research and development (R&D) expenses were $18.7 million for the three months ended June 30, 2026, compared to $17.2 million in the same period in 2025, with the increase driven primarily by the ongoing ALD trial as well as the startup costs for the 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 2025. R&D expenses for the quarter ended June 30, 2026, included $11.6 million in direct costs related to pemvidutid

EX-99.1

2 alt-20260513xex99d1.htm

EX-99.1

Exhibit 99.1

Altimmune Announces First Quarter 2026 Financial Results and Business Update

​

Initiation of PERFORMA Phase 3 MASH trial planned for second half 2026

$535 million in cash, cash equivalents and short-term investments as of April 30, 2026

Webcast to be held today at 8:30 a.m. ET

​

GAITHERSBURG, MD – May 13, 2026 – Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing pemvidutide to address serious liver diseases, today announced financial results for the first quarter ended March 31, 2026, and provided a corporate update.

“We continue to make significant progress across multiple fronts, as we enter a new phase for Altimmune,” said Jerry Durso, President and Chief Executive Officer of Altimmune. “As a result of the recent successful financing with top-tier biotech investors, we now have a strong cash position that enables us to focus on execution and delivering on our goal of bringing pemvidutide to patients with serious liver diseases and create long-term value for our shareholders. Looking ahead, we have several important milestones this year, including the initiation of the PERFORMA Phase 3 MASH trial, topline data from the RECLAIM Phase 2 AUD trial, and enrollment completion in the RESTORE Phase 2 ALD trial.”

​

Highlights and Anticipated Milestones

​

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

●Pemvidutide was granted Breakthrough Therapy Designation by the FDA based on 24-week data from the IMPACT Phase 2b trial

●The Company expects to initiate its global PERFORMA Phase 3 MASH trial in the second half of 2026, with 52-week data readout anticipated in 2029

oThe PERFORMA trial is a Phase 3, Multinational, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Clinical Outcomes of Pemvidutide in Subjects with MASH

●The study protocol has been finalized and submitted to the FDA

●The PERFORMA Phase 3 registrational trial design is aligned with feedback from the FDA and EMA

●Scientific data to be presented at European Association for the Study of the Liver (EASL) Congress 2026

oA late-breaking oral presentation on the 48-week IMPACT data in MASH will be delivered by Dr. Mazen Noureddin, Professor of Medicine, Houston Methodist Hospital; Chief Scientific Officer and Co-Chairman, Summit Clinical Research, on May 28, 2026 at 5 p.m. CEST. Abstract selected as “Best of EASL 2026”.

oA late-breaking poster abstract: Pemvidutide Treatment Led to Fibrosis Regression After 24 Weeks in Patients with MASH: Quantitative Digital Pathology Analysis from the Phase 2b IMPACT Trial

oA poster abstract: Concurrent Responses in Multiple Non-Invasive Tests for Hepatic Inflammation and Fibrosis Following Pemvidutide Treatment: 24-Week Responder Analyses from the Phase 2b IMPACT Trial in MASH

oA poster abstract: Effect of Pemvidutide on Cardiovascular Risk Factors in Patients with MASH: 48-Week Results from the Phase 2b IMPACT Trial

​

Alcohol Use Disorder (AUD)

●Topline data from the RECLAIM Phase 2 trial of pemvidutide in AUD expected in third quarter 2026

oThe RECLAIM trial is evaluating the safety and efficacy of pemvidutide versus placebo in approximately 100 patients with AUD over a 24-week treatment period

oEnrollment 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

oThe RESTORE trial is a 48-week study evaluating the safety and efficacy of pemvidutide versus placebo in approximately 100 patients with ALD

oExpect enrollment completion in third quarter 2026

​

Corporate Update

●Strengthened balance sheet

oIn 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

oIn the first quarter of 2026, the Company raised $8.9 million via the At-the-Market (ATM) facility

oIn April 2026, the Company completed an oversubscribed public offering of common stock, pre-funded warrants, and stock warrants, resulting in gross proceeds of $225.0 million

​

​

​

​

Financial Results for the Three Months Ended March 31, 2026

●Altimmune reported cash, cash equivalents and short-term investments totaling $332 million as of March 31, 2026

oAs of April 30, 2026, the Company had approximately $535 million of cash, cash equivalents and short-term investments reflecting the net proceeds from the $225 million oversubscribed public offering of common stock, pre-funded warrants, and stock warrants in April 2026

●Research and development (R&D) expenses were $16.2 million for the three months ended March 31, 2026, compared to $15.8 million in the same period in 2025, with the increase driven primarily by the ongoing AUD and ALD trials as

ALTIMMUNE, INC._March 5, 2026 0001326190false00013261902026-03-052026-03-05 ​

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 5, 2026

ALTIMMUNE, INC.

(Exact name of registrant as specified in its charter)

​ ​

​

​

​

​

Delaware

001-32587

20-2726770

(State or other jurisdiction of incorporation)

(Commission File Number)

(IRS Employer Identification No.)

​ ​ ​ ​ ​

910 Clopper Road, Suite 201S Gaithersburg, Maryland ​ ​ ​ 20878

(Address of principal executive offices) ​ ​ ​ (Zip Code)

​ Registrant’s telephone number including area code: (240) 654-1450 (Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: ​ ​

​

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

​ Securities registered pursuant to Section 12(b) of the Act: ​

Title of each class Trading Symbol(s) Name of each exchange on which registered

Common stock, par value $0.0001 per share ALT The NASDAQ Global Market

​ Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ ​ ​ ​

​ ​ Item 2.02 Results of Operations and Financial Condition On March 5, 2026, Altimmune, Inc. (the “Company”) issued a press release announcing the Company’s financial results for its fourth quarter and full year ended December 31, 2025. A copy of this press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information included in this Current Report on Form 8-K (including Exhibit 99.1 hereto) that is furnished pursuant to this Item 2.02 shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. In addition, the information included in this Current Report on Form 8-K (including Exhibit 99.1 hereto) that is furnished pursuant to this Item 2.02 shall not be incorporated by reference into any filing of the Registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing, unless expressly incorporated by specific reference into such filing. ​ Item 9.01 Financial Statements and Exhibits ​ (d) Exhibits ​

​

​

No. ​ Description

​ ​ ​

99.1 ​ Press Release of Altimmune, Inc. dated March 5, 2026

​ ​ ​

104 ​ Cover Page Interactive Data File (embedded within the Inline XBRL document)

​ ​ ​

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. ​ ​

​

​

​

​

ALTIMMUNE, INC.

​ ​ ​ ​

​ By:

/s/ Gregory Weaver

​ ​

Name: Gregory Weaver

​ ​

Title: Chief Financial Officer

​ Dated: March 5, 2026 ​