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Clinical Progress

• MASH: The global PERFORMA Phase 3 registrational trial of pembidutide in MASH was initiated last week, with patient enrollment ongoing. The trial will run across ~300 global sites (1/3 in the U.S., 2/3 ex-U.S.). Management reports fast site activation and strong engagement from the medical and scientific communities. Pembidutide's balanced 1:1 glucagon/GLP-1 agonist mechanism is expected to offer a differentiated profile for MASH patients.
• Alcohol Use Disorder (AUD): Positive top-line data from the Phase II Reclaim trial was reported in July 2026. Pembidutide 2.4 mg met all primary and secondary endpoints, including a highly statistically significant 1.45 day per week reduction in heavy drinking days versus placebo. Two-thirds of pembidutide patients achieved a 2-level reduction in WHO-RDL (versus 1/3 of placebo patients), and more than twice as many pembidutide patients achieved zero heavy drinking days versus placebo. The drug also demonstrated statistically significant improvements in percent abstinent days, PEth levels (objective blood measure of alcohol intake), and 9.1% body weight reduction from baseline. Exploratory analysis found 50% of pembidutide patients with elevated baseline FIB-4 (a liver fibrosis risk biomarker) achieved FIB-4 <1.3 after 24 weeks, versus 17% of placebo patients. Management is compiling full trial data to request an end-of-Phase II meeting with the FDA to discuss the registrational path for AUD.
• Alcohol-Associated Liver Disease (ALD): Patient enrollment in the Phase II RESTORE trial (enrolling ~120 patients with ALD and chronic heavy drinking) is complete. The trial protocol was amended to assess the primary endpoint (change in liver stiffness measurement, LSM) hierarchically at week 48 followed by week 24, to better characterize long-term liver benefits. Top-line data is expected in the second half of 2027.

Commercial & Strategic Positioning

• The AUD market is significantly underpenetrated: ~27 million U.S. adults meet AUD criteria, 12 million of whom have moderate-severe AUD, and only 10% of AUD patients are diagnosed, with just 25% of diagnosed patients receiving pharmacotherapy. No new AUD therapies have been approved in 20 years, creating large unmet need.
• Pembidutide's unique dual benefit (reducing alcohol cravings + providing direct liver benefit) differentiates it from competing AUD therapies in development that only target drinking behavior. There is substantial overlap between the MASH, AUD, and ALD patient populations, allowing hepatologists/gastroenterologists to manage all three conditions with a single therapy.
• Pre-commercial market research shows 44% of hepatologists and 27% of gastroenterologists already screen AUD patients during MASH evaluations, creating a built-in pathway for diagnosis and treatment.

• Current cash reserves of $519 million are sufficient to fund operations through the 52-week top-line readout of the PERFORMA MASH Phase 3 trial, expected in 2029. This does not include funding for a potential Phase 3 AUD trial.
• Management prefers non-dilutive financing options (royalty arrangements, debt, strategic partnerships) to fund the Phase 3 AUD trial, and expects the strength of the positive Reclaim Phase 2 data will provide multiple viable funding options. A cost estimate and formal update will be provided after regulatory feedback on the Phase 3 design is received.
• Management expects PERFORMA MASH trial enrollment will take 18 to 24 months, with a target of completing enrollment at the lower end of this range based on strong initial site interest.
• No formal guidance on Phase 3 AUD timing is provided at this stage; management will update after completing the full Reclaim data analysis and holding end-of-Phase 2 meetings with U.S. and EU regulators.

Altimmune is a clinical-stage biotech focused on serious liver disease therapies, with no revenue from product sales as of Q2 2026. All operating spending is directed to R&D and G&A activities:

• R&D expense: $18.7 million in Q2 2026, up from $17.2 million in Q2 2025. Of this, $11.6 million was directly for pembidutide development: $3.8 million for MASH, $5.3 million for the Phase II AUD and ALD trials, and $2.5 million for CMC-related work. Non-cash stock compensation in R&D was $1.1 million.
• G&A expense: $7.6 million in Q2 2026, up from $5.7 million in Q2 2025, driven by higher professional fees and compensation expenses. Non-cash stock compensation in G&A was $1.7 million.
• Net loss: $22.8 million ($0.12 per share) in Q2 2026, compared to a net loss of $22.1 million ($0.27 per share) in Q2 2025.
• Balance sheet: Total cash and cash equivalents as of June 30, 2026 was $519 million, following ~$310 million in gross proceeds raised year-to-date 2026, including a $225 million follow-on offering in April 2026.

• Forward-looking statements (including trial timelines, enrollment projections, and regulatory expectations) are subject to inherent risks and uncertainties that could cause actual results to differ materially from expectations, as detailed in the company's SEC filings.
• MASH Phase 3 trials operate in a competitive enrollment environment, with multiple other pivotal programs ongoing that could compete for patient and site resources.
• Successful clinical development of pembidutide in AUD and ALD depends on positive regulatory feedback from the FDA and EMA regarding trial design, and the ability to secure adequate non-dilutive funding to support the Phase 3 AUD program. Efficacy and safety outcomes from earlier-stage trials may not be replicated in larger late-stage trials.

Q: How is Altimmune addressing competition for patients and sites in the PERFORMA MASH Phase 3 trial, and what are enrollment expectations? / A: Management designed the trial to reduce screen failures and set reasonable patient enrollment targets per site, allowing sites to participate in multiple trials simultaneously. This structure has generated strong interest from principal investigators. The trial targets 18-24 months for full enrollment, and management currently expects to hit the lower end of this range based on early engagement. The amendment does not change the trial's powering assumptions, as the company was already collecting 48-week data; it only adjusts the statistical analysis plan to strengthen characterization of liver benefits, which aligns with the company's differentiation strategy focused on overlapping AUD/ALD patient populations.

Q: Is one global pivotal trial still the base case for AUD, and has strategic partner interest increased after the positive Reclaim data? / A: Per recent FDA guidance, one high-quality pivotal trial with validated endpoints is expected to be sufficient for approval. Management plans to conduct one global Phase 3 trial that will include a portion of overlapping AUD/ALD patients, leveraging safety data from other pembidutide programs to support the filing. The company remains actively engaged in exploring global partnership opportunities, and the positive Reclaim data has increased pembidutide's strategic value, which is reflected in ongoing discussions.

Q: What is the rationale for including BMI <25 patients and potential lower doses in the AUD Phase 3 trial, and what is the differentiation versus competing incretin-based AUD candidates? / A: Approximately one-third of moderate-severe AUD patients have BMI <25, so expanding inclusion allows pembidutide to address the full patient population. Testing a lower dose accommodates patients who may achieve sufficient efficacy at lower exposure with better tolerability. Unlike competing candidates that combine GLP-1 and GIP and only target drinking behavior, pembidutide combines GLP-1 and glucagon, and offers direct liver benefits for patients who often have underlying undiagnosed liver damage, which is expected to be a key differentiator.

Q: How will the AMASH AI pathology tool be used in the PERFORMA trial, and what are the expected benefits? / A: Biopsy slides are digitalized, and the AI tool identifies relevant features and proposes a fibrosis/activity score. Board-certified pathologists retain final scoring authority per FDA requirements. The AI tool is expected to reduce scoring variability between pathologists, improve reading consistency, reduce screen failures during enrollment, and reduce variability in the efficacy endpoint reading. PERFORMA is the first Phase 3 trial to use this AI tool, which has generated strong early interest from trial sites.