11/10/2022

speaker
Moderator
Conference Call Moderator

Good day, ladies and gentlemen, and welcome to the Altamont, Inc. Third Quarter Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. To ask a question during the session, you will need to press star 1-1 on your telephone. As a reminder, this call is being recorded. I would now like to introduce your host for today's conference, Rich Einstadt, Chief Financial Officer of Elliman. Rich, please go ahead.

speaker
Rich Einstadt
Chief Financial Officer of Elliman

Thank you, Michelle, and good morning, everyone. Thank you for participating in Altimmune's third quarter 2022 financial results conference call. Members of the Altimmune team joining me on the call today are Vipin Garg, our chief executive officer, Scott Roberts, our chief scientific officer, and Scott Harris, our chief medical officer. Following the prepared remarks, we will have a question and answer session. Press release with our third quarter 2022 financial results was issued this morning and can be found on the investor relations section of the company's website. Before we begin, I would like to remind everyone that remarks about future expectations, plans, and prospects constitute forward-looking statements for purposes of safeguarding provisions under the Private Securities Litigation Reform Act of 1995. Ought to be in caution that these forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those indicated, including those related to the ongoing conflict in Ukraine, COVID-19, the impact on our business operations, clinical trials, and results of operations. For discussion of some of the risks and factors that could affect the company's future results, please see the risk factors and other cautionary statements contained in the company's filings with the SEC. I would also direct you to read the forward-looking statement disclaimer in our press release issued this morning and now available on our website. Any statements made on this conference call speak only as of today's date, Thursday, November 10th, 2022, and the company does not undertake any obligation to update any of these forward-looking statements to reflect events or circumstances that occur on or after today's date. As a reminder, this conference call is being recorded and will be available for audio replay on Altamead's website. With that, I will now turn the call over to Dr. Wippengard, Chief Executive Officer of Altair.

speaker
Dr. Wippengard
Chief Executive Officer of Altair

Thank you, Rich, and good morning, everyone. We appreciate you joining us today for a discussion of our third quarter 2022 financial results and business update. We are excited about the progress we are making with Pembidutide, our GLP-1 glucagon dual receptor agonist, that we continue to advance for two important clinical indications, obesity and NASH. The recent data from our Phase 1b NAFLD trial highlighted a 68.5% relative liver fat reduction at 12 weeks in the 1.8 milligram dose group, which translated into more than half of those subjects achieving a normal liver fat content of 5% or less. These promising effects on liver fat content were accompanied at week 12 by significant reduction in serum ALT levels and CT1 imaging relaxation times. Both recognized biomarkers of fibroinflammatory activity. Subjects receiving pembidutide also lost a significant amount of body weight, which differentiates pembidutide from other drugs with comparable effects on liver fat and ALT reduction. This is important because excess body weight is believed to be a principal driver of NASH and its comorbidities, and weight loss represents an important therapeutic goal in the treatment of these patients. In mid-December, we plan to announce the top-line data readout on a trial extension that offered 12 weeks of additional treatment to subjects who completed the original 12-week Phase 1b trial in subjects with NASLD. The key readouts will be similar to the readouts in the original 12-week study. Scott Harris will join us shortly to discuss our expectations for that readout. Obesity remains our primary focus, and we completed randomization and first dosing of all subjects in our 48-week Phase II Momentum Obesity Trial at the end of September. A 24-week interim analysis is planned for Q1 2023 when we expect that approximately 160 subjects will have completed 24 weeks of treatment. We believe the interim readout should demonstrate meaningful weight loss with favorable tolerability in the absence of dose titration, which could differentiate Pembidutide from other obesity products. Scott Harris will present more on Momentum Trial in a moment. Enrollment is also complete in our 12-week phase 1b multicenter safety trial in subjects with type 2 diabetes, and we expect this trial to provide important information regarding the ability of pembidutide to maintain glucose control in this population as measured by hemoglobin A1c and serum glucose levels. Finally, we are continuing to enroll our phase 2 multicenter trial of hep T cell in subjects with inactive chronic hepatitis B and expect to have a data readout in the second half of 2023. Recall that this study is designed to show evidence of antiviral effects against HPV and establish its potential role in combination therapy for the treatment of this important disease. We are excited about the progress of pembidutides and hep T cell and the upcoming results of these ongoing trials. With that, I will now turn the call over to our Chief Medical Officer, Dr. Scott Harris, to discuss our data and clinical plans. Scott?

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