Altimmune, Inc. (ALT) Q3 2025 Earnings Call

Investor webinar replay

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and in the ongoing regulatory conversation. The statistical significance achieved across a panel of NITs we are assessing in the IMPACT trial provides strong support for pemvidutite antifibrotic effects, which we will look to continue to assess in the upcoming 48-week readout. Speaking of the 48-week readout, We look forward to assessing the data and the potential of a longer treatment duration on NEAT measurements, as well as further weight loss. Recall, we had early and significant MASH resolution in our 24-week biopsy data and strong evidence of antifibrotic activity supported by the NEAT analysis, along with the continuing weight loss and excellent tolerability. The emerging recognition that improvements in certain NITs are likely to translate to clinical improvement has led regulatory agencies to consider allowing the use of NIT data as a measure of efficacy in MASH clinical trial. In clinical practice, MASH patients are often diagnosed and courses of treatment determined based on these non-invasive tests, and the possibility of the regulatory agencies more closely aligning with clinical practice, bodes particularly well for pembidutite given the strength of our neat data. Dr. Mazen Nouragin, lead investigator on the IMPACT trial, will deliver a late-breaking oral presentation on the 24-week IMPACT results at the upcoming annual ASLD liver meeting. The acceptance of this abstract reinforces the significance of the data from the IMPACT trial and Pemvidutide's opportunity in the broader MASH landscape. Our confidence in Pemvidutide is underscored by the collective data surrounding the molecule from the seven trials completed to date. We are now preparing for a scheduled face-to-face end-of-phase two meeting with the FDA before year-end to review our proposed Phase...