Altimmune, Inc.

Good day, ladies and gentlemen, and welcome to Altamune, Inc.' 's third quarter 2024 financial results conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. As a reminder, this call is being recorded. I would now like to introduce your host for today's conference call, Lee Roth of Burns McClellan, Investor Relations Advisor to Altamune. Lee, you may begin.

Thanks, Operator. Good morning, everyone. And once again, thank you for participating in Altamune's third quarter 2024 financial results and business update conference call. On today's call, you'll hear from Dr. Vipin Garg, our chief executive officer, Dr. Scott Harris, our chief medical officer, and Andrew Shutterly, our acting chief financial officer. Dr. Scott Roberts, our chief scientific officer, and Greg Weaver, our newly appointed chief financial officer, are on the line as well and will join us for the Q&A session. A press release covering our third quarter of 2024 financial results and corporate update was issued earlier this morning and can be found on the investor relations section of the company's website. Before we begin, I'd like to remind everyone that remarks about future expectations, plans, and prospects constitute forward-looking statements for purposes of the safe harbor provision under the Private Securities Litigational Reform Act of 1995. All to me in caution is that these forward-looking statements are subject to risks and uncertainties that could cause our actual results to differ materially from those indicated. For a full review of the risk factors that could affect the company's future results and operations, we refer you to our filings with the SEC. I'll also direct you to read the forward-looking statements disclaimer in our press release issued this morning, which is now available on our website. Any statements made on this call speak only as of today's date, November 12th, 2024, 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. As a reminder, this call is being recorded and will be available for audio replay on the Altamune website. With that, it's my pleasure to turn the call over to Dr. Vipin Garg, Chief Executive Officer of Altamune. Vipin?

Thank you, Lee. Good morning, everyone, and thank you for joining us for our third quarter corporate update. In the three months since our last conference call, we have achieved several important milestones. These recent accomplishments, coupled with other upcoming catalysts, give us a high degree of confidence that we are in position for 2025 to be a transformational year for Altimmune. First, our Phase 2b IMPACT trial of pembidutide in MASH is now fully enrolled, and top-line efficacy data is expected in Q2 2025. With a successful readout from IMPACT, pembidutide would be the first MASH therapy to achieve both fibrosis improvement and significant weight loss at 24 weeks of treatment. Following this readout, we expect to hold an end-of-Phase II meeting for MASH with FDA in Q4 2025. For our obesity program, as announced last week, we achieved alignment with the FDA at our recent end-of-Phase II meeting on a comprehensive Phase III registration program designed to leverage the key attributes of Pembidutide. The important strategic takeaway here is that we now have a differentiated phase three ready asset that we believe has the potential to benefit obese and overweight patients and fill gaps in the treatment of the comorbidities of obesity left by existing treatments currently on the market. To realize the full potential of Pembidutide, we have made the strategic decision to expand our R&D investments into development of up to three additional indications that leverage the enhanced glucagon activity and other attributes of pemidutide. We plan to submit an IND for the first of these indications by the end of 2024. And preparations are underway for the initiation of that Phase II clinical trial in H1 2025, in the first half of 2025. We believe each of these indications represents a substantial commercial opportunity that will create value for our shareholders. Importantly, these indications were chosen as we believe we can develop these indications ourselves, and we expect to provide more details in the coming months. To summarize, our overarching development strategy continues to focus on securing a partnership centered around obesity, while moving full speed ahead to advance Pembidutide in MASH and launch development efforts in these additional indications. Upon a positive data readout from Phase IIb impact trial in the second quarter of 2025, we expect to be ready to start a Phase III program in MASH by the end of next year. We continue to believe that Pembidutide is a highly differentiated agent from others and in strategically important ways relative to the current metabolic disease landscape. With that, I'll now turn the call over to our Chief Medical Officer, Dr. Scott Harris, to discuss our clinical plans in more details. Scott?

Thank you, Vipin. As noted, we completed enrollment in the Phase IIb Impact Trial of Pemfidutide in MASH in late September. and are on track to report top-line efficacy data in the second quarter of next year. Recall, the trial is evaluating approximately 190 subjects with and without diabetes, randomized one to two to two to receive either 1.2 milligrams, 1.8 milligrams of penfututide or placebo for 48 weeks. The key efficacy endpoints are mass resolution or fibrosis improvement at 24 weeks of treatment. with subjects followed for an additional 24 weeks to a total of 48 weeks for safety and biomarker responses. Pempedutide has the potential to be the first incretin agent to achieve statistical significance in MASH resolution and fibrosis improvement rates at only 24 weeks. Combined with the weight loss achieved with pempedutide therapy, these results could position pempedutide to become the standard of care in the treatment of MASH at the completion of the phase three registrational program. As we continue to analyze the data from our completed clinical trials, it is increasingly clear that pembidutide not only has a meaningful impact on body weight, but also the comorbidities associated with obesity. We're particularly excited about the results from our phase two MRI-based body composition sub-study reported at the recent European Association for the Study of Diabetes Conference in September of this year. That study demonstrated class-leading preservation of lean mass of only 21.9% in subjects treated with pembidutide as well as a preferential reduction in visceral adipose tissue. This type of fat has been associated with cardiovascular risk. The preservation of lean mass is a key factor in both the quantity, quality, and sustainability of weight loss and will be the focus of one of our four Phase III studies. As Vipin discussed, we completed our end of Phase II meeting with the FDA last week. This interaction resulted in alignment with the agency on an innovative, registrational program encompassing four pivotal Phase III studies. each designed to leverage a specific attribute of penvidutide in the setting of weight reduction. Let me recap the plan designed of the four trials that we outlined in last week's press release. Velocity 1. This trial will assess the effects of penvidutide on body weight in patients with obesity or overweight without diabetes. Other endpoints will include reductions in waist circumference, lipids, and blood pressure. Velocity 2. This trial will assess the effects of pembidutide on body weight and serum lipids in subjects with obesity or overweight and elevated LDL cholesterol levels. The study population will include a subset of subjects with elevated LDL cholesterol despite concomitant statin therapy. A large proportion of patients taking statins failed to achieve target LDL levels, and in a previous Phase II clinical trial in subjects with overweight or obesity, pemphidutide appeared to enhance LDL-lowering effects in these subjects. Velocity 3. This trial will assess the effects of pemphidutide on body weight in subjects with obesity or overweight and elevated liver fat. Excess liver fat is highly prevalent in patients with obesity and is associated with an increased risk of cardiovascular disease. Velocity 4. This trial will assess the effects of Pembedutide on body weight and body composition with emphasis on elderly individuals and individuals with sarcopenia at baseline. Functional measures and activities of daily living will also be assessed in this patient population. The Phase III Registrational Velocity Program will evaluate three doses of Penvidutide, 1.2 milligrams, 1.8 milligrams, and 2.4 milligrams administered one weekly via subcutaneous injection over a 60-week treatment period. Collectively, the four trials are expected to enroll approximately 5,000 subjects, similar to past registrational programs in obesity. Our intention is to obtain regulatory approval for each of these doses, allowing patients to start on therapy on a Pembedutide dose with demonstrated efficacy for weight loss. The successful completion of the FDA End of Phase II meeting for obesity represents an important milestone in the development of Pembedutide, not only de-risking the regulatory path for approval in obesity, but also positively impacting the development of Pemfidutide and MASH and the additional indications we are pursuing. We believe that Pemfidutide has broad therapeutic potential beyond obesity and MASH. We are exploring up to three additional indications for which Pemfidutide's profile as a balanced GLP-1 glucagon dual agonist may be ideally suited. We expect to submit an IND application for a Phase II clinical trial in the first indication by year end, with the study expected to initiate in the first half of 2025. We'll provide further information about these indications as regulatory discussions are completed. With that, I'll now hand over the call to our Acting Chief Financial Officer, Andrew Shutterly, to review our financial results for the third quarter.

Andrew? Andrew Shutterly Thank you, Scott, and good morning. For today's call, I will be providing a brief overview of Altamune's third quarter 2024 financial and operating results. More comprehensive information will be available in our Form 10-Q to be filed with the SEC later today. Altamune ended the third quarter of 2024 with approximately $139.4 million of cash, cash equivalents, and short-term investments, compared to $198 million at the end of 2023. We project that our existing cash will fund us well into the first half of 2026, which fully funds our impact trial in MASH, including the expected readout of top-line biopsy data in the second quarter of 2025. Research and development expenses were $19.8 million in the third quarter of 2024, compared to $18.4 million in the same period in 2023. Our R&D expenses for the third quarter of 2024 included approximately $12.4 million in direct costs related to development activities for Pembe-Dutide and $0.8 million in direct costs related to additional research and discovery projects. General and administrative expenses were $5 million in the third quarter of 2024 versus $4.5 million in the third quarter of 2023. The increase was due primarily to a $0.4 million increase in professional services costs. Included in the R&D and G&A costs for the third quarter of 2024 are approximately $3.1 million of non-cash stock-based compensation expense, compared to $2.7 million in the same period in 2023. Net loss for the three months ended September 30, 2024 was $22.8 million, or a $0.32 net loss per share, compared to a net loss of $20.7 million, or a $0.39 net loss per share, for the third quarter of 2023. I will now turn it back over to Vipin for his closing remarks. Vipin?

Thank you, Andrew, and thank you for everything you have done serving as our acting CFO over the last several months. As Lee mentioned at the start of the call, Greg Beaver, who joined our team yesterday as Chief Financial Officer, is with us for the Q&A session. Welcome, Greg. Over a distinguished 25-year career, Greg has led the finance function at a number of public and private life sciences companies. We are excited to have him on board and look forward to benefiting from his deep expertise. We are encouraged by the significant strides we have made over the last several months. While we are in a fast-moving and highly competitive space, we are more confident than ever that Pemidutide has the potential to stand out from the crowd, and we believe that we are well-equipped to seize the opportunity that lies ahead. That concludes our formal remarks. We would now like to open the lines to take questions. Operator?

Thank you. As a reminder, to ask a question, please press star 11 on your telephone. and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Yasmine Rahimi from Piper Sandler.

Good morning, team. Congrats on all the updates and congrats, Greg, for joining a wonderful company and look very much forward to working closely with you. team um really exciting that you got the velocity studies um aligned with the agency um and and that's and kicking it off i guess the question that we have for you is now that you have the alignment how important was the alignment in terms of strategic discussion and partnership that's sort of question one question two are you still planning to if you're planning to kick off the studies would they be occurring in a sequential order or at the same time. And then the third question is, if you could shed some light on what are these additional indication you're potentially considering for which you're following INDs, that would be helpful. And I'll jump back into the queue.

Thank you. Yeah, thanks for the question, Yas. In terms of how important it is, this is really a significant and very important milestone for development of Pembidutide. I mean, this was a comprehensive review of our package so far, all of the studies that we have conducted. Very importantly, pembidutide got a clean bill of safety, and Scott can talk more about that. And we have clear understanding as to what needs to be done, what are the full registrational trials that would lead to approval of the drug. So we think this is a very important milestone for pembidutide for Altimmune and for our potential partners. Our strategy is to continue to look for a partnership centered around obesity, and we're moving full speed ahead with MASH and other indications. In terms of studies, the sequencing of them, ideally they would all be run in parallel, but Scott can comment more about that, as well as additional indications. We haven't really disclosed the details of additional indications at this point, but what I can say is that these are all designed to leverage the advantages of glucagon in pemidutides. It's really focused around the properties of glucagon and some of the liver defatting and serum lipid improvement that we have seen from our momentum trial. We'll talk more about these indications once we have had regulatory alignment. We are planning to file our first IND later this year, and hopefully we'll talk more about this 30 days after the IND clears the FDA. Scott, can you provide some more color on the FDA interactions as well as on the sequencing of the three indications, sorry, the four velocity trials?

Sure. So the meeting was extremely successful. A lot of compliments were passed on the line during the meeting, and we have now exposed over 500 subjects to pembajutides, and completed trials. And based on that, the FDA looked at our safety profile and gave us a thumbs up on that exposure. Obviously, the final consideration is what you have at NDA, but no safety signals were identified from that interaction. They also confirmed our plan for the four studies, which did not include a diabetes trial, although we are including diabetics in our program. We'll have an ample number. to evaluate, but they felt this was a reasonable approach and really liked the idea of targeting the effects most likely to be impacted by glucagon, including the body composition study. Regarding the launching of the studies, the sequence is still to be determined as we look to operationalize that and hope to have more details for you in the near future.

Thank you so much. I'll jump back in the queue.

Thank you. One moment for our next question. Our next question comes from the line of Ellie Merle from UBS.

Hi, this is Jasmine for Ellie. Thanks so much for taking our question and congratulations on all your progress. So thinking about the recent top line GLP-1 essence trial data we saw in NASH, What we saw there on fibrosis, how are you thinking now about what you'd like to see from impact in QQ and what is really competitive now for incretins in the NASH base? Thanks.

Scott. Hi, Jasmine. I think I heard you ask the question about the recently completed ESSENCE trial. Is that correct? Am I correct on that?

Yes, yes, and just how kind of that's impacted your thinking now about what's competitive for incretins and MASH.

Right. Well, the trial results were as we expected. You know, you have to recognize that the trial went for 72 weeks. It was longer than other trials, so a longer opportunity to see an effect because of the longer treatment. As well, the study power was increased by going over and aboard what was done in another Phase III program, so a large number of subjects in order to show that statistical significance. The treatment effect was modest. This is what we would expect from an agent like semaglutide that exerts its effects on liver fat indirectly through weight loss rather than direct effects on the liver. And as we've seen when glucagon has been in the mix or when there's a liver-targeted effect like FGF21, the liver fat and the endpoints move up considerably with more robust effects. So moving forward to Pemvidutide, the liver fat is what drives the mass resolution and the fibrosis improvement. That should have been shown repeatedly in trials. We have class-leading liver fat reduction. The FGF21 showed meaningful and statistically significant effects in mass resolution and fibrosis improvement at 24 weeks, their liver fat reduction. was about 65%. We're at the 76% level. We have preclinical studies demonstrating a direct effect of pembidutide on fibrosis that's independent of defatting, and we've done a number of other analyses suggesting success at 24 weeks. So where do we stand in comparison to Essence? If we are successful, and I believe we will, we will be the first incretin-based agent to show statistical significance, that is success, on mass resolution and fibrosis improvement at only 24 weeks. And, combined with the weight loss associated with pebdutide, the only agent at 24 weeks to offer weight loss because, as you are aware, the current compounds that have shown efficacy at 24 weeks have either been associated with no weight loss or actually even weight gain. And we believe that these combined effects will really put us at the front of the class in terms of the MASH drugs going toward approval.

Awesome.

Thank you. I just want to add that really combining these two effects provides a complete solution for treating MASH. Not only are we going to show direct effect on the liver, but at the same time, it's a good thing in this patient population for patients to lose weight. So this combination There's a lot of discussion already about combination therapy. That's basically what we are doing with pembidutide is providing a combination of direct liver acting effect with weight loss.

Wonderful. Thank you. Thank you. One moment for our next question. Our next question comes from the line of Lisa Baco from Evercore. Your line is now open.

Hi, thanks for taking the question and congrats on all the progress. Sort of two line of questioning for me. First of all, I guess as it relates to cardiac safety, do you think FDA views this as a class effect and it might be something that sort of comes up as you talk about, go back to FDA and discuss the fuller phase three program, including mash, which I think is what you intend to sort of prioritize yourself. I just curious about that. Or is this something where they've seen something specific in the server do tie data just seems to me with the ratio that they have versus the ratio you have and and the fact that you do have quite a bit of glucagon. I'm wondering if that's something that kind of gets revisited. And then curious about the timing of the additional indications. Really interesting concept. Are you going to wait for data in MASH before initiating those and really taking off, or when should we expect to learn more about that? Thanks.

Thanks, Lisa. Thanks for the questions. Let's take your first question first. Scott, you want to get started?

Yeah, Lisa.

That's a great question.

It's a great question. This is not a class effect. Repeatedly in all of our trials, we've seen no evidence of arrhythmias, no evidence of any effects on coronary disease, cardiovascular disease, no MACE effects, and we've also seen no evidence of any changes on EKG intervals or the like. And we've seen this repeatedly in all of our studies. And we laid out all of the data for the FDA, and the FDA came to the same conclusion. So our conclusion would be that what's been described in the Cervidutide program is probably specific to the compound. And we achieved confirmation at the FDA that they agree on that opinion. Regarding the timing of the studies, we'll launch the study in the first half of next year. We'll have to see whether that actual launch goes before or comes after the mass readout, and we'll have more information for you as we get into next year.

Okay, great. One quick follow-up. Just can you remind us for servodutide, were those signals that they saw, the increase in heart rate and all those things, were they early events or late events? In other words, do they happen after six months or earlier in the study? Thanks.

You know, Lisa, we don't know. What we know, when we went to the FDA, we presented our whole program and they did a comprehensive evaluation of the program. And again, they indicated no safety signals, and like all of the other sponsors that have proceeded in obesity, allowed us to design a program with purely efficacy trials. As you are aware, you need about 5,000 subjects in total to go to NDA in obesity. That is exposed for a year. And we and other sponsors have usually achieved that by filling it up with efficacy trials, and that's what Velocity one, two, three, and four is. With the Cervidutide program, they've elected to conduct two smaller efficacy trials and a very large safety trial, which is actually designed to show no harm versus placebo, specifically to cardiac events. One would imagine that that could be suggestive of a discussion that the company had with FDA. We don't know. So really can't comment about the signal. What we can say is that the design of their program is unusual and is oriented towards showing safety more than it is to show efficacy. Okay.

Thank you.

And I think to be very clear, you asked a question about the Phase III program. This was a comprehensive interaction with the FDA, and there is no requirement for pembidutide to do additional safety studies.

Got it. Thanks. Thank you. One moment for our next question. Our next question comes from the line of Zhao Tong, JIA, from Jefferies.

Hi, team. This is Fiona for Roger from Jefferies. My question is, I have two questions regarding the three additional indications. First is, I think I remember that you mentioned in the call that these indications you're going to carry forward independently, or is it part of the ongoing conversation regarding partnerships? Thank you. And I have a follow-up.

Yeah, thank you for the question. Look, these indications have been designed to continue to improve or enhance the value of pembidutide. The idea, you know, really, as we've said from the very beginning, pembidutide has the potential for a pipeline in a product because of its many attributes. So they're all designed to really look at certain comorbidities of obesity, not obesity directly. And we believe they will not only create value for family due type, these are indications we can pursue on our own, and they will be attractive to potential partners as well. So it's really designed to continue those discussions, and if a partnership can be built around these indications, we'll be very keen to do so, but we can also develop these on our own. So it really gives us a lot of flexibility, a lot of optionality as to how we move forward with these indications.

Got it. Thank you. That's very helpful. And my second question is, does the cash runway to 1 1⁄2 on 26 cover these three indications? Thank you.

Yes. The initial plans, the initial IMD filings, as well as the initial Phase II type of trials that we would conduct around them that... the current cash will be sufficient for us to conduct these.

Awesome. Thank you. Congrats on the quarter.

Thank you.

Thank you. As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Our next question comes from the line of Corin Johnson from Goldman Sachs.

Hi, this is Omari for Corin. I also have a couple questions on the three indications. How are you thinking about which indications you'll select to move forward, and what are the size of these trials that you anticipate beginning in the first half of 2025? Scott?

The three indications are based on targets which would benefit from glucagon. These are all indications that involve subjects with obesity and overweight. And consequently, it is not only demonstrated in effect on these three specific targets, but also the effects of pembidutide on body weight. So it has also implications for the obesity program as well. We'll provide further details about the invocations once we have complete regulatory discussions. Hope to have that in the very near future. Regarding the launching of the studies and the size of the studies, we'll provide more information again about that next year. We do expect to file the first IND by the end of this year and to commence activities to launch that trial in the very near future. But I want to emphasize that these will not be phase one studies. These will all be phase two proof of concept studies. So we're really moving ahead into mid-stage development into all of these indications once the IND is clear.

Got it. Thank you.

Thank you. One moment for our next question. Our next question comes from the line of Mayank Mamthani from B Reilly Securities.

Hi, good morning team. This is William on for Mayank. Thanks for taking our questions and congratulations on a great quarter and congratulations on the recently hiring of Greg. We have a couple of questions. Digging a little bit deeper, just kind of curious about the phase three essence data that we will be expecting at ASLD coming up. I guess maybe what are you looking for specifically in that data that really could help provide or inform your confidence in your ongoing phase two impact study? Any extra insight there could be helpful? And then I have a follow-up.

Yeah, William, again, there were a lot of details that were not included in that initial readout. You know, some of the questions about the statistical approaches, completers, and the like. I don't think that really changes the way we view the study. We think the effects were predictable. We think the effects were modest and represented the long duration of treatment and the supersizing of the study power. It would be of interest to see the details of that study. We certainly will watch the presentation with everyone else, but we really think the effects of the study are modest in that they speak to our having an even better readout to the effects at a much earlier time point showing enhanced efficacy at a time point that could not be hit by semaglutide. It would just be too soon to see those effects.

Got it. And then an additional question on your strategic partnerships. These have been going on for a little while now, beginning around the end of your phase two momentum readout. I'm just kind of curious how your discussions with potential partnerships have evolved over time now that we're getting closer to phase two impact. Obviously, Essence readout and now your three additional indications. Any color on that? you know, the evolving conversation, and if they're now starting to expand across multiple, you know, the broader potential of the do-tide, any color on that would be helpful. Thank you.

Yeah, absolutely. Ray, do you want to take that question? Our Chief Business Officer Ray is here, so Ray Jordan.

Yeah, thank you for the question. As you mentioned, you know, the strategic partner discussions, you know, we've been engaged with throughout the period of 2024. What's interesting, I think, is in our approach has always been to, you know, continue to generate data and advance the programs. And why I say that is because the feedback I think we received generally has been from these companies that they're still trying to figure out their own strategic initiatives. You know, how do they leverage their capabilities What's their strategy to jump into obesity? And I think that feedback is fairly accurate because there have been no other deals that have been executed for now about 12 months now. So I think the feedback we're receiving is genuine. I think other companies are still trying to figure out how they jump into it. And so I think what's important for us is to continue to generate the data, advance the programs, keep generating value for everyone. And I think things are starting to resonate. So, again, the preservation of lean mass, I think that's a very unique attribute for pembidutide, and that's been a hot topic in this space. The MASH indication, I think, is gaining even more traction, I think, with the ResDifera launch. I think more attention is being focused there. And, again, Scott and Vipin have talked about how we believe we'll be positioned there with the combination of direct efficacy, 24 weeks, and weight loss is going to be differentiating. And I think the additional indications is going to be something that will even create more value, broaden the offering. So at a high level, I think these would be things that benefit our strategic partnering discussions as well as Altimmune in general.

Thanks, Ray. And I would just add that the conclusion of the end of Phase 2 meeting, successful conclusion of the end of Phase 2 meeting, is a very important milestone in moving these discussions forward. path is clear now we know you know how the program looks and what are the what are the the trial designs and how much it's going to cost really to to take this to the finish line so I think all all that being in place we are you know we continue to do to seek a partnership centered around obesity got it very helpful I'll hop back in the queue and congrats again on a very nice quarter

Thank you. At this time, I would now like to turn the conference back over to Vipin Garg for closing remarks.

Thank you, everyone, for joining our call today. As always, we sincerely appreciate your continued support and interest in Altimmune as we work diligently to advance Pembidutide. Thank you again for your time. We look forward to updating you on our progress in the near future. Have a great rest of your day.

this concludes today's conference call thank you for participating you may now disconnect