pemvidutide (ALT-801) / Altimmune - LARVOL DELTA

Efficacy and Safety of Incretin-Based Therapies in Metabolic Dysfunction-Associated Steatotic Liver Disease: A Systematic Review and Meta-Analysis of Randomized Trials (ACG 2026) - "Agents included liraglutide, semaglutide, dulaglutide, tirzepatide, pemvidutide, survodutide, efinopegdutide, and retatrutide... Sixteen MASLD/MASH randomized trials were included. Five biopsy-based trials contributed to MASH/NASH resolution without worsening fibrosis (n=1,226); incretin-based therapy increased resolution versus control (RR 2.80, 95% CI 1.60â4.90; p=0.007; I²=66.6%). Four biopsy-based trials reported fibrosis improvement without MASH worsening (n=1,181), favoring incretin-based therapy (RR 1.52, 95% CI 1.13â2.05; p=0.021; I²=0%)."

Retrospective data • Review • Constipation • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Hepatology • Immunology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

Defining the efficacy and tolerability ceiling of pure incretin therapies in steatotic liver disease: a network meta-analysis of phase 2 and 3 trials (EASD 2026) - "(1) Liver Fat Clearance (MRI-PDFF): The tri-agonist retatrutide achieved the highest efficacy hierarchy (SUCRA 98%), yielding a -82.4% relative reduction in hepatic steatosis. GLP-1/glucagon dual-agonists (mazdutide, efinopegdutide) consistently outperformed both GLP-1/GIP agents and pure GLP-1 mono-agonists...While earlier dual-agonists (survodutide, cotadutide) exhibited high adverse event-related discontinuation rates (15.2-20.0%), next-generation agents (mazdutide, pemvidutide) maintained placebo-like tolerability (<1.0% discontinuation) alongside profound hepatic fat clearance. Multi-receptor incretin agonism yields a stepwise, dose-and-receptor dependent superiority in clearing hepatic steatosis compared to pure GLP-1 therapy. While the addition of glucagon drives unparalleled fat clearance, optimizing the tolerability profile remains the defining factor for the clinical viability of next-generation incretins."

P2 data • Retrospective data • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

Efficacy and Safety of Dual and Triple Glucagon-Like Peptide-1-Based Polyagonists in Metabolic Dysfunction-Associated Steatotic Liver Disease and Steatohepatitis: A Systematic Review and Meta-Analysis. (PubMed, Cureus) - "The included GLP-1-based polyagonists-tirzepatide, survodutide, pemvidutide, retatrutide, and cotadutide-significantly increased MASH resolution or histological improvement without worsening of fibrosis (RR 3.32, 95% CI 2.28-4.84; I² = 20%) and fibrosis improvement without worsening of MASH (RR 1.49, 95% CI 1.15-1.94; I² = 0%)...However, gastrointestinal intolerance, pharmacological heterogeneity, the small number of trials, and limited follow-up warrant cautious interpretation. Larger phase 3 trials are needed to clarify drug-specific efficacy, long-term safety, and effects on liver-related and cardiovascular outcomes."

Journal • Retrospective data • Review • Cardiovascular • Diabetes • Fibrosis • Genetic Disorders • Hepatology • Immunology • Liver Cirrhosis • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity • Type 2 Diabetes Mellitus

Pemvidutide, a balanced glucagon/GLP-1 dual receptor agonist, alters adipose tissue composition in participants with overweight or obesity (EASD 2026) - P2 | "Treatment with the dual glucagon/GLP-1 agonist pemvidutide for 48 weeks produced a dose-dependent reduction in the fat composition of thigh subcutaneous adipose tissue. Given that higher water content in adipose tissue has been shown to be associated with better metabolic status, these findings support the hypothesis that pemvidutide may improve adipose tissue quality and metabolic health in individuals with overweight or obesity. Future work should examine the relationship between these potential structural changes and direct measures of adipocyte action and adipose tissue perfusion."

Metabolic Disorders • Obesity

PERFORMA: Phase 3 Study of the Efficacy, Safety, and Clinical Outcomes of Pemvidutide in MASH (clinicaltrials.gov) - P3 | N=1800 | Recruiting | Sponsor: Altimmune, Inc.

New P3 trial • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

RESTORE TRIAL: Study of the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD) (clinicaltrials.gov) - P2 | N=121 | Active, not recruiting | Sponsor: Altimmune, Inc. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Mar 2027 ➔ Sep 2027

Enrollment closed • Trial primary completion date • Hepatology

Altimmune…announced that the company has begun enrolling patients in the PERFORMA Phase 3 trial evaluating the efficacy and safety of pemvidutide in patients with metabolic dysfunction-associated steatohepatitis (MASH) (GlobeNewswire) - "The PERFORMA trial is a global, Phase 3, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and clinical outcomes of pemvidutide in MASH patients with moderate to advanced fibrosis. PERFORMA is Altimmune's registrational study for pemvidutide in MASH and will assess the effects of treatment on fibrosis improvement and MASH resolution as well as clinical outcomes. The trial follows positive findings from the IMPACT Phase 2b study and incorporates feedback from the U.S. Food and Drug Administration (FDA) and European regulatory agencies. The 52-week data readout from the trial is anticipated in 2029."

Enrollment open • P3 data • Metabolic Dysfunction-Associated Steatohepatitis

RECLAIM STUDY: Phase 2 Study of the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol Use Disorder (AUD) in Subjects With Obesity or Overweight (clinicaltrials.gov) - P2 | N=100 | Completed | Sponsor: Altimmune, Inc. | Active, not recruiting ➔ Completed | Trial primary completion date: May 2026 ➔ Jul 2026

Trial completion • Trial primary completion date • Addiction (Opioid and Alcohol) • Genetic Disorders • Obesity

Pemvidutide treatment led to fibrosis regression after 24 weeks in patients with metabolic dysfunction-associated steatohepatitis: quantitative digital pathology analysis from the IMPACT phase 2b, multicenter, randomized, placebo-controlled trial (EASL 2026) - P2 | "Pemvidutide treatment for 24 weeks resulted in significant fibrosis regression in patients with F2 or F3 MASH as measured by qFibrosis® quantitative digital pathology. These data, together with previous AI- and NIT-based analyses, may support an antifibrotic effect with pemvidutide treatment as early as 24 weeks."

Clinical • Digital Pathology • Late-breaking abstract • P2b data • Fibrosis • Hepatology • Immunology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

Effect of pemvidutide on cardiovascular risk factors in patients with metabolic dysfunction-associated steatohepatitis: 48-week results from the phase 2b, IMPACT trial (EASL 2026) - P2 | "Pemvidutide treatment resulted in reductions in key cardiovascular risk factors. Significant reductions in body weight, waist circumference, serum lipids, and blood pressure may be indicative of broad improvements in cardiovascular disease."

Clinical • P2b data • Cardiovascular • Diabetes • Fibrosis • Genetic Disorders • Hepatology • Hypertension • Hypertriglyceridemia • Immunology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Obesity • Type 2 Diabetes Mellitus

Concurrent responses in multiple non-invasive tests for hepatic inflammation and fibrosis following pemvidutide treatment: 24-week responder analyses of the phase 2b IMPACT trial in metabolic dysfunction-associated steatohepatitis (EASL 2026) - P2 | "Pemvidutide treatment led to statistically significant increases in the proportion of patients achieving concurrent responses in multiple NITs of MASH resolution and hepatic fibrosis at 24 weeks."

Non-invasive • P2b data • Diabetes • Fibrosis • Hepatology • Immunology • Inflammation • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Type 2 Diabetes Mellitus

Week 48 top-line results from the phase 2b, multicenter, randomized, placebo-controlled IMPACT trial of pemvidutide in metabolic dysfunction-associated steatohepatitis (EASL 2026) - P2 | "Treatment led to significant, dose-dependent reductions in NITs of MASH inflammation and fibrosis, as well as clinically meaningful weight loss at week 48."

Clinical • P2b data • Diabetes • Fibrosis • Hepatology • Immunology • Inflammation • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Type 2 Diabetes Mellitus

Pemvidutide Demonstrates Significant Metabolic Improvements in Patients with MASH in New 48‑Week IMPACT Phase 2b Data Presented at EASL 2026 (GlobeNewswire) - "Pemvidutide 1.8 mg treatment resulted in significant reductions in serum lipid levels among patients with elevated baseline values versus placebo, including: Triglycerides reductions of -23.7%; Total cholesterol reductions of -15.4%. In addition to lipids, pemvidutide 1.8 mg treatment resulted in significant improvements in other metabolic risk factors versus placebo: Weight loss of 7.5%, continuing throughout treatment with no plateauing; Reductions in body mass index of -3.0 kg/m2; Reductions in waist circumference (a measure of visceral adiposity that is associated with increased cardiovascular risk) of -5.3 cm....'We are eager to initiate our PERFORMA Phase 3 trial later this year'..."

New P3 trial • P2b data • Metabolic Dysfunction-Associated Steatohepatitis

IMPACT TRIAL: Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - P2 | N=212 | Completed | Sponsor: Altimmune, Inc. | Trial primary completion date: Apr 2025 ➔ Nov 2025

Trial primary completion date • Hepatology • Metabolic Dysfunction-Associated Steatohepatitis

Highlights and Anticipated Milestones (GlobeNewswire) - "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: The 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."

New P3 trial • P3 data • Metabolic Dysfunction-Associated Steatohepatitis

Altimmune to Present Results of Pemvidutide in MASH in an Oral Presentation and Multiple Poster Presentations at EASL Congress 2026 (Yahoo Finance) - "Abstract presenting 48-week IMPACT Phase 2b efficacy and safety data selected for inclusion in 'Best of EASL 2026' by EASL; Oral presentation will highlight further the 48-week IMPACT efficacy and safety data; Late-breaker abstract featuring new digital pathology analysis of liver fibrosis regression from IMPACT 24-week data."

P2b data • Metabolic Dysfunction-Associated Steatohepatitis

Altimmune Announces Closing of $225 Million Oversubscribed Public Offering of Securities (The Manila Times) - "Altimmune intends to use the net proceeds to fund its upcoming Phase 3 trial in MASH, as well as for working capital and general corporate purposes. Altimmune expects to initiate its Phase 3 trial in MASH in the second half of 2026."

Financing • New P3 trial • Metabolic Dysfunction-Associated Steatohepatitis

Altimmune Announces Proposed Underwritten Public Offering of Securities (GlobeNewswire) - "The proposed public offering is subject to market and other conditions, and there can be no assurance as to whether or when the proposed public offering may be completed or as to the actual terms of the offering. Altimmune intends to use the net proceeds from this proposed offering to fund its upcoming Phase 3 trial in metabolic dysfunction-associated steatohepatitis (MASH), as well as for working capital and general corporate purposes."

Financing • Metabolic Dysfunction-Associated Steatohepatitis

Efficacy and safety of pemvidutide in metabolic dysfunction-associated steatohepatitis: a GRADE-assessed meta-analysis of randomized controlled trials. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "Pemvidutide significantly improves hepatic and metabolic parameters in MASLD/MASH with acceptable tolerability. Larger, longer trials are warranted to confirm antifibrotic efficacy."

Journal • Retrospective data • Cardiovascular • Heart Failure • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

Altimmune Announces Fourth Quarter and Full-year 2025 Financial Results and Business Updates (The Manila Times) - "Initiation of Phase 3 MASH trial planned for 2026....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."

New P3 trial • Metabolic Dysfunction-Associated Steatohepatitis

Glucagon-like peptide 1 receptor agonists in substance use disorders: A systematic review of ClinicalTrials.Gov. (PubMed, Addict Behav Rep) - "Agents studied included semaglutide (n = 15), exenatide (n = 8), tirzepatide (n = 6), liraglutide (n = 2), dulaglutide (n = 1), and pemvidutide (n = 1)...While GLP-1RAs may represent a paradigm shift for treating SUD, current trials have focused on alcohol and nicotine/tobacco use disorders, with notable gaps for methamphetamine and cannabis use disorders. Trials testing next-generation GLP-1RAs with FDA recommended endpoints are needed to define efficacy and safety across SUDs."

Journal • Addiction (Opioid and Alcohol) • Nicotine Addiction • Substance Abuse • Tobacco Addiction

Systemic Pharmacokinetic Principles of Therapeutic Peptides. (PubMed, Clin Pharmacokinet) - "In summary, our results underscore that the systemic pharmacokinetics of peptide drugs generally follow size-related physiological scaling patterns and provide quantitative tools to facilitate translational assessments in the drug discovery process."

Journal • PK/PD data

Altimmune Announces Pricing of $75 Million Registered Direct Offering of Common Stock (GlobeNewswire) - "Altimmune intends to use the net proceeds to fund preparation for its upcoming Phase 3 trial in metabolic dysfunction-associated steatohepatitis (MASH) as well as for working capital and general corporate purposes."

Financing • New P3 trial • Metabolic Dysfunction-Associated Steatohepatitis

Altimmune Receives FDA Breakthrough Therapy Designation for Pemvidutide in MASH (Yahoo Finance) - "Breakthrough Therapy Designation for pemvidutide in MASH was granted based on submission of 24-week data from the IMPACT Phase 2b trial demonstrating statistically significant MASH resolution without worsening of fibrosis, along with early and substantial improvements in liver fat and non-invasive tests of fibrosis and hepatic inflammation....The Company plans to initiate a Phase 3 trial evaluating multiple pemvidutide doses over a 52-week treatment period."

Breakthrough therapy • New P3 trial • Metabolic Dysfunction-Associated Steatohepatitis

IMPACT TRIAL: Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - P2 | N=212 | Completed | Sponsor: Altimmune, Inc. | Active, not recruiting ➔ Completed

Trial completion • Hepatology • Metabolic Dysfunction-Associated Steatohepatitis