Altimmune, Inc. (ALT) Earnings

Management highlights

- Corporate and Financial Progress * Completed an oversubscribed public offering in April 2026, generating $225 million in gross proceeds from top-tier biotech investors, providing cash runway through the 52-week Phase 3 MASH data readout expected in 2029 * Strategically expanded the management and clinical team to support the company's transition to a late-stage development organization - Lead Program (Pemidutide for MASH) * Pemidutide is a balanced 1:1 glucagon/GLP-1 dual agonist with a proprietary U-port structure that slows absorption, improving tolerability and reducing GI side effects to support higher treatment adherence, a critical factor for chronic disease management * Received FDA Breakthrough Therapy Designation for MASH; finalized the global Phase 3 trial (PERFORMA) protocol and submitted it to the FDA, and received aligned scientific advice from the EMA, clearing the final regulatory milestone for trial initiation * Partnered with a CRO with deep MASH Phase 3 experience, and is currently activating experienced global trial sites in preparation for patient screening in H2 2026 * The 48-week Phase 2 IMPACT trial data will be presented as a best-of-abstract oral presentation at the upcoming EASL conference, with three additional posters on fibrosis, cardiovascular risk factors, and weight loss * Phase 3 will test the 1.8 mg (anchor dose from Phase 2) and 2.4 mg (demonstrated additional weight loss in prior obesity studies) doses with a simple 1-2 step titration schedule to further improve tolerability - Additional Clinical Programs * Top-line data from the Phase 2 RECLAIM trial of Pemidutide for Alcohol Use Disorder (AUD) is expected in Q3 2026; the trial tests 2.4 mg once weekly vs placebo in 100 subjects, with primary endpoint of change in heavy drinking days * Full enrollment of the Phase 2 RESTORE trial for alcohol-related liver disease (ALD) is expected in Q3 2026 - Commercial Differentiation * Market research confirms unmet need for MASH therapies with good tolerability that do not sacrifice efficacy; Pemidutide demonstrated lower treatment discontinuation rates than placebo in Phase 2, compared to 25% GI-related discontinuation for competitors even with long multi-step titration schedules * Pemidutide produces steady, non-plateaued weight loss that preserves lean muscle mass, a critical benefit for the primarily 55-60 year old MASH patient population at higher risk of sarcopenia and adverse outcomes

Guidance

- Global Phase 3 PERFORMA MASH trial initiation is on track for the second half of 2026, with 52-week biopsy data readout for accelerated approval expected in 2029, maintaining prior guidance - Top-line data from the Phase 2 AUD RECLAIM trial is confirmed for the third quarter of 2026, maintaining prior guidance - Full enrollment of the Phase 2 ALD RESTORE trial is expected in the third quarter of 2026, maintained from prior guidance - No changes to previously stated clinical development timelines for any program

Segment performance

Altamune is a clinical-stage biotech with no commercial product segments, so there is no segment revenue generation or performance to report. All operating expenses are focused on clinical development of lead candidate Pemidutide. For Q1 2026, total R&D expense was $16.2 million, up from $15.8 million in Q1 2025: $9.5 million of this was direct Pemidutide development cost, split into $3.7 million for MASH development, $4.2 million for AUD and ALD Phase 2 trials, and $1.6 million for CMC-related expenses. Non-cash stock compensation for R&D was $1.2 million. G&A expense for Q1 2026 was $8.1 million, up from $6 million in Q1 2025, driven by higher severance and professional fees; non-cash stock compensation for G&A was $2.1 million. Net loss for Q1 2026 was $22.6 million (18 cents per share), compared to a net loss of $19.6 million (26 cents per share) in Q1 2025. As of April 30 2026, pro forma cash balance after the April 2026 public offering was $535 million.

Risks & headwinds

- Forward-looking statements (including trial timelines, efficacy expectations, and commercial potential) 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 - Clinical trial success is not guaranteed; trial outcomes may not match the positive efficacy and tolerability signals observed in Phase 2 testing - Competitor therapies (including GLP-1 monotherapies, dual agonists, and triple agonists) may erode potential market share or demonstrate superior clinical profiles - Regulatory feedback may require changes to trial design or endpoints that could delay development or increase costs

Analyst Q&A

• Q: With the Phase 3 MASH trial finalized ahead of H2 initiation, have there been any changes to trial design, sample size, or statistical power? What are the go-no-go criteria for advancing the AUD program to Phase 3 after the upcoming readout?

  A: The PERFORMA trial is fully powered to meet its primary endpoints for registration; there are no planned interim analyses other than the 52-week biopsy readout for accelerated approval and the final event-driven clinical outcome readout. After the Q3 2026 Phase 2 AUD data readout, management will fully assess the data, discuss results with regulators, and evaluate whether to advance the program. If moving forward, management prefers to pursue non-dilutive funding options for AUD development to preserve shareholder value.

• Q: How does Pemidutide differentiate from semaglutide in AUD, and are Phase 3 regulatory endpoints for AUD already clear from regulators?

  A: Semaglutide's positive AUD data validates the core biological hypothesis that GLP-1 modulation reduces alcohol cravings, but Pemidutide's added 1:1 glucagon activity directly targets early liver disease (steatosis, inflammation, fibrosis) common in AUD patients, which GLP-1 monotherapies cannot do because the liver has no GLP-1 receptors. The FDA has identified two acceptable primary endpoints for AUD Phase 3: zero heavy drinking days or a two-step reduction in WHO drinking risk level; management will select the appropriate endpoint based on Phase 2 data and discussions with the FDA.

• Q: What new data will be presented at the upcoming EASL conference, and what is the difference between the Q-fibrosis AI analysis and the AIM MASH Assist digital pathology tool that will be used in Phase 3?

  A: EASL presentations will include the full 48-week Phase 2 IMPACT trial data (selected as best abstract for oral presentation), additional data on 24-week antifibrotic effects via the Q-fibrosis AI tool, and data on weight loss, lipids, and cardiovascular risk in MASH patients. Q-fibrosis is a standalone AI approach that subtracts steatosis signal to more accurately measure early fibrosis changes, while AIM MASH Assist is a regulatory-qualified tool that assists pathologists in reading biopsy slides to reduce variability for the Phase 3 primary endpoint. The Roche acquisition of PathAI (developer of AIM MASH Assist) has not changed planned use of the tool for PERFORMA, and Altamune will be the first registration trial to use it.

• Q: What is the rationale for the Phase 3 titration strategy and inclusion of both 1.8 mg and 2.4 mg dose arms, and what is the statistical design for the two arms?

  A: Phase 2 tested 1.2 mg and 1.8 mg without titration, and found 1.2 mg had placebo-like tolerability while 1.8 mg had only mild GI effects. The simple one-step titration from 1.2 mg to 1.8 mg leverages this tolerability to further improve patient adherence. 1.8 mg is the powered anchor dose based on strong Phase 2 efficacy data, while 2.4 mg (which showed added weight loss in obesity trials) is included as an exploratory arm for potential additional efficacy. The study is powered based on the 1.8 mg effect size to maintain statistical robustness.