11/6/2025

speaker
Christophe
Chief Medical Officer

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 III MASH program. The Phase III trial will include the flexibility of using NIDS and AI reads as an approvable endpoint in our registrational program if regulatory process moves in that direction. Beyond MASH, we believe that the balanced glucagon and GLP-1 agonism that is the hallmark of PEMVD type makes it a promising therapeutic candidate in both alcohol use disorder, and alcohol-associated liver disease. In AUD, we have completed recruitment and randomization in the reclaimed trial. That we were able to fully enroll this trial ahead of schedule is a strong indicator of the significant interest and major unmet need in this indication. We look forward to reporting results next year. Our ALD trial restore was initiated in the third quarter, and enrollment is ongoing. Importantly, patients with ALD currently lack any approved therapies, and we believe pemvidutide's dual mechanism of action may make a difference for these patients. We look forward to these results of these trials and further understanding the potential of pemvidutide in these additional large patient populations of unmet need. I am excited to be at Altimmune and to lead these programs forward. And with that, I will turn the call to our Chief Commercial Officer, Linda Richardson, to discuss how we are preparing for Phase 3 success in NASH. Linda?

speaker
Linda Richardson
Chief Commercial Officer

Thanks, Christophe, and good morning, everyone. It's great to be here at Altimmune at this exciting time, and I echo Christophe's enthusiasm for joining this team and helping to shape the future of this significant therapeutic candidate. A quick background on me. I've been involved in all facets of commercialization for over 30 years at organizations of all sizes. I have experience in MASH, rare hepatic diseases, cardiometabolic diseases, including diabetes and dyslipidemia, and addiction medicine. We have a great opportunity in front of us with Pembidutide and MASH, as well as AUD and ALD, and I look forward to helping prepare for potential commercialization in each of these areas of high unmet need. My decision to join Altimmune was driven by the opportunity to bring real therapeutic advances to patients and the providers that care for them. Pembidutide has this potential. Why do I believe this? With Pembidutide, we have one therapy that provides two important mechanisms of action, delivering improvements on three critical elements of MASH management. The single therapy is clear. The two mechanisms of action, glucagon and GLP-1 agonism, in a balanced one-to-one ratio, provide both direct liver effects and metabolic improvements, resulting in three important benefits for patients. One, rapid mass resolution in as soon as 24 weeks. Two, anti-inflammatory and anti-fibrotic effects in the liver, as demonstrated in multiple NIT assessments. And three, quality weight loss including lean muscle sparing effects. Additionally, Pembedutide has demonstrated a potential best-in-class tolerability profile with low discontinuation rates in the impact trial. This could be another differentiating feature compared with other MASH therapies. My enthusiasm aside, I would like to highlight some feedback from recent market research we did in Europe. Healthcare professionals in a small group of payers were provided with a projected blinded product profile of Pembedi along with other blinded profiles of current and future potential MASH therapies. First, 70% to 80% of the physicians surveyed indicated a high or very high likelihood to prescribe pembidutide based on the blinded product profile in both F2 and F3 patients. Here are some representative qualitative comments from hepatologists on PEMBI's differentiating features. It's quite impressive, the fibrosis and the weight loss. Seems to be a class leader, and the side effect profile is good. And another quote, for overweight and obese patients, it would be my go-to substance, my first-line approach, more powerful than other dual agonists, with strong fibrosis data. Lean mass preservation would be a meaningful differentiator, very important in MASH and chronic liver disease. This is very encouraging early feedback. In particular, the significance of demonstrating lean muscle mass preservation is potentially very differentiating. There is a growing interest in the prevalence and effects of sarcopenia in patients with Masl-D. A 2024 meta-analysis found that sarcopenia was associated not only with progression, but also correlated with Masl-D associated mortality. Other publications project that the prevalence of sarcopenia may be as high as one in four patients. Initial payer feedback was also encouraging. Payers provided us with a positive reimbursement outlook across the EU, with broad coverage expected given payers' positive perception of the PEMBV value proposition. We will continue to identify aspects of PEMBV-type therapy that may be important to payers, particularly as more therapies enter the mesh field. Patient and prescriber receptivity is critical, but reimbursement and access are equally important elements of a successful product launch. I've had the opportunity to work closely with our clinical team to incorporate specific endpoints that we believe will be important drivers of market uptake and support a successful launch following potential regulatory approval. It's an optimal time to ensure that commercial considerations are designed into the Phase III MASH program to accentuate the differentiators of pembidutide from current approved therapies and those to come. Alongside MASH, the AUD and ALD programs are very exciting. and could expand substantially the addressable market for pembidutide. The rapid recruitment of our AUD trial that we discussed earlier is evidence of interest in this space, and the patient need for new therapeutic options as well. In closing, I'm very excited to be here at Altamune at such a crucial time. I look forward to continuing to update all of you on our commercial vision, plans, and expectations for pembidutide. I'll now turn it over to Greg to review our financial results for the third quarter.

speaker
Greg
Chief Financial Officer

Thank you, Linda, and hello. Beginning with our balance sheet of September 30, total cash was $211 million, representing an increase of 60% over our cash position at the start of the year. We've made measurable strides as we source capital through a combination of available options, having raised $127 million through the first nine months of the year. building the cash position required to support our key development milestones. Another step we've taken to add to our financial flexibility was to amend our Hercules debt agreement, where we increased the overall facility size to $125 million and funded $20 million on executing that amendment today. The amendment improves several of the key terms, extending the interest-only period, for example. You'll see that we're filing a $400 million shelf registration today, along with a new 200 million ATM facility. Consider these filings as part of our ongoing effort to assure the financial tools are in place to meet our needs going forward. Our cash position continued to strengthen through Q3 and into Q4. I'm happy with the trajectory and confident in the ability to build the balance sheet required to meet our development needs and position PIMV for success. Now to comment on the Q3 and year-to-date financial results. R&D expenses were $15 million for the three months ended September 30, 2025, compared to $19.8 million in the same period of 2024. The three-month variance in R&D spend was related to the timing of CRO development costs year over year. The Q3 2025 spend included $9.2 million of direct costs related to Pemba-Dutai development, including Roughly $3.7 million for the IMPACT Phase 2B trial, $3.4 million for AUD and ALD startup costs, and $1.3 million for CMC. G&A expenses were $5.9 million and $5 million for the quarter ended September 30, 2025, and 2024, respectively. This increase was driven by professional fees and non-cash stock-based compensation. To note, the total non-cash stock-based comp was $3.6 million in Q3 and $11.1 million year-to-date. No surprises there. Net loss of the third quarter of 2025 was $19 million, or $0.21 a share, compared to $22.8 million, or $0.32 per share, in the third quarter of last year. So in summary, we are well-positioned in terms of our financial footing. And with that, I'll turn the call back to Vipin for some closing remarks.

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