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Altimmune, Inc. Q3 2026 Earnings Call Summary

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Altimmune, Inc. Q3 2026 Earnings Call Summary Moby Intelligence Thu, November 12, 2026 at 1:03 PM EST 3 min read NVDA -4.80% ALT -11.69% Explore stocks on Coinbase Trading disclosure Trading disclosure The above button links to Coinbase. Yahoo Finance is not a broker-dealer or investment adviser and does not offer securities or cryptocurrencies for sale or facilitate trading. Coinbase pays us for certain activity generated through this link. Prices displayed are informational.

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Management attributes pemvidutide's clinical differentiation to its balanced 1-to-1 glucagon to GLP-1 ratio and proprietary UPORT domain, which they believe optimizes the balance between metabolic and liver-directed activity.

The company is executing a strategy to build a broad liver franchise by targeting the patient continuum across MASH, AUD, and ALD, noting that 55% to 94% of ALD patients also meet AUD criteria.

The Phase 3 PERFORMA trial in MASH is currently ramping up with over 70 US sites activated, driven by strong investigator engagement and a trial design that management describes as efficient.

Positive Phase 2 RECLAIM data in AUD is viewed as a significant de-risking event, demonstrating statistically significant improvements in both self-reported and objective measures of alcohol consumption.

Management highlighted that pemvidutide's lack of significant drug interactions and favorable tolerability profile are critical for treating patients with comorbid conditions who require multiple chronic medications.

The strategic rationale for targeting AUD includes the high unmet need in the moderate-to-severe segment, which comprises approximately 12 million Americans at high risk for progressing to severe liver damage.

The company anticipates the 52-week data readout for the global Phase 3 PERFORMA MASH trial in 2029, with current cash reserves expected to provide a runway through this milestone.

An End of Phase 2 meeting with the FDA is scheduled for December 2026 to align on the Phase 3 study design and regulatory path for the AUD program.

Top-line data for the Phase 2 RESTORE trial in ALD is expected in the second half of 2027, which management believes will strengthen the eventual AUD regulatory filing package.

Management is prioritizing non-dilutive funding sources, such as royalty debt or strategic partnerships, to finance the upcoming Phase 3 AUD program.

The Phase 3 AUD program is expected to focus on moderate-to-severe patients and will likely include a subpopulation with advanced liver impairment to address current gaps in available therapies.

R&D expenses increased to 27 million in Q3 2026 from 15 million in the prior year, primarily due to the initiation of the Phase 3 MASH trial and ongoing ALD studies.

The company added Peter Greenleaf and Alex Horvath to its Board of Directors to provide strategic expertise in late-stage drug development and commercialization.

Cash and investments totaled 480 million at the end of the quarter, which management expects will fund operations through the 2029 MASH data readout.

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Management expects enrollment to take approximately 18 to 24 months, with over 70 US sites currently active and ex-US sites expected to activate in the coming months.

The 2.4 mg dose included in the Phase 3 trial is intended to offer potential upside in weight loss and efficacy compared to the 1.8 mg dose studied in Phase 2.

Management views recent data from competitors as validation of the dual-agonist mechanism and the 12-month biopsy timeframe utilized in the PERFORMA trial.

They believe pemvidutide compares favorably to other molecules in the class due to its specific 1-to-1 ratio and tolerability profile.

The company plans to propose the WHO Risk Drinking Level (RDL) as the primary endpoint for the Phase 3 AUD trial, as it is a registrational endpoint that reached statistical significance in Phase 2.

The Phase 3 program will likely include lean patients (BMI below 25) to broaden the addressable population beyond those with obesity.

Altimmune intends to leverage its existing safety database of over 750 exposed patients across multiple trials to potentially limit the specific safety exposure requirements for the AUD population.

Read original at Yahoo Finance News

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