Altimmune, Inc.

Good morning, ladies and gentlemen, and welcome to the Altamune First Quarter 2026 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'll need to press star 1 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 1 again. As a reminder, this call is being recorded. I'll now introduce your host for today's conference call, Luis Sine, Vice President of Investor Relations. Luis, you may begin.

Thank you, operator, and good morning, everyone. Thank you for joining us for Altimmune's first quarter 2026 financial results and business update call. On today's call, you'll hear from Jerry Durso, our President and Chief Executive Officer, Dr. Christoph Arbid Engels, Chief Medical Officer, Linda Richardson, Chief Commercial Officer, and Greg Weaver, Chief Financial Officer. Following management's prepared remarks, we'll open the line for the Q&A session. Our first quarter 2026 earnings release was issued this morning and can be found on the investor relations section of our website. Before we begin, I would like to remind everyone that remarks made about future expectations, plans, and prospects constitute forward-looking statements for purposes of safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Altamune cautions that these forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those indicated. For a review of the risk factors that could affect the company's future results and operations, we refer you to our SEC filings. I also direct you to read the forward-looking statements disclaimer in our press release issued this morning. Any statements made on this call speak only as of today's date, May 13th, 2026, 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 call is being recorded and will be available for audio replay on our website.

With that, I'll now turn the call over to Jerry Durso. Good morning, everyone, and thank you for joining us today for our first quarter 2026 financial results and business update call. During our last earnings call, I discussed that one of my first priorities as CEO was to strengthen Altimmune's foundation to equip us for the continued successful advancement of Pemidutide and support our evolution into a late-stage development company. Since the start of the year, we've made significant progress across multiple fronts and are excited about the opportunities ahead of us. Let me take a moment to highlight our recent progress. First, we have continued to enhance and build our team strategically to ensure we are best positioned to deliver on our vision as we enter a new phase for Altamute. We've also remained focused on strengthening our financial foundation. Importantly, in April we completed An oversubscribed public offering resulting in $225 million in gross proceeds. The proceeds from the April offering, along with our existing funds, results in a cash balance of approximately $535 million as of April 30th. We now have the financial resources to fully fund the company through our Phase 3 MASH 52-week data readout, which is expected in 2029. This financing highlights the confidence and the conviction of participating top-tier biotech investors in the potential of Pembidutide and represents another key step towards bringing Pembi to patients. We're entering a new phase for the company with the right team in place and a very strong balance sheet, and we're now focused on execution and believe we're well-positioned to successfully execute our strategies. We believe that Pembidutide has the potential to bring meaningful benefit to people affected by a variety of hepatic diseases. The balanced one-to-one agonism of glucagon and GLP-1 in a single molecule achieved with PEMVI makes it potentially well-suited for the liver conditions we're targeting. Additionally, PEMVI incorporates our proprietary U-port structure, which slows absorption and is believed to drive improved tolerability, potentially reducing GI and other side effects. This can lead to greater treatment adherence. Importantly, keeping patients on therapy at the right dose is crucial to the management of chronic diseases such as MASH. Recent market research we've conducted points to attributes that would drive prescribing in MASH, including a highly favorable tolerability profile that does not sacrifice efficacy and quality weight loss. These are two of the potentially differentiating characteristics of Pembidutide based on our clinical trials to date. As the MASH market continues to evolve, There remains a significant unmet need, and we believe PEMV has the potential to offer a differentiated profile for patients. Furthermore, the potential of PEMV has been recognized with breakthrough therapy designation in MASH by the FDA. We're continuing to advance our efforts and expect to initiate our global phase three study in MASH in the second half of this year. The MASH phase three trial will be called the PERFORMA trial. We've now finalized the study protocol and submitted that to the FDA as part of the standard process. We've also completed the scientific advice process in Europe, and the final study protocol is aligned with the feedback we've received from EMA. So Altimmune is fully focused on the startup phase for a large global phase three trial. We're moving quickly, partnering with the CRO who brings deep know-how in the MASH phase three space. The Altimmune team is working closely with them and we're progressing to activate the most experienced trial sites, and then we'll look forward to initiating patient screening. While we have significant focus on our lead MASH program and initiating the performance study, we're also progressing on two additional indications. First, in AUD, an area of high unmet need, we remain on track to report top line data from our phase two trial next quarter. We remain encouraged by the strong scientific interest in this indication, and look forward to the data readout. In ALD, we now expect a complete enrollment of the RESTORE trial in the third quarter of this year. Pemba Dutide represents a unique and compelling opportunity to improve the lives of people with MASH and other liver conditions. It has the potential to become an important tool for physicians as they look to improve upon the current treatment paradigm and meet the needs of their patients. With a stronger team in place and cash run way through the top line readout of our PERFORMA phase three MASH trial, we're now laser focused on execution. We're moving with urgency on bringing PEMV to patients who may benefit from its promising therapeutic profile and creating long term value for our shareholders. With that, I'll turn the call over to Christoph for a clinical update.

Thank you, Jerry. The startup activities for the PERFORMER Phase III MASH trial continue to progress as planned, and we are well on our way towards initiating the study in the second half of the year. In the last few weeks, we have finalized and submitted the study protocol to the FDA, and the Altimmune team is working closely with our CRO partner. We are ensuring the global infrastructure, vendors, labs, and clinical supply chains are in place to support a successful trial. These activities will allow us to initiate screening and start enrolling patients in the second half of the year. We are also pleased to report alignment on the phase three trial design with both FDA and now EMA. As we expected, feedback received from EMA validated our planned trial design and represented the final regulatory step in our phase three preparation. This is an important milestone in our global development strategy, as the data from the PERFORMER Phase III trial will form the basis for regulatory submission in multiple regions. Importantly, we achieved strong efficacy results at both 24 and 48 weeks in the Phase II impact trial, particularly at 1.8 mg. We will introduce the 2.4 mg Pemvidutide dose in Phase III which has achieved additional weight loss in a previous obesity study and could potentially show increased liver efficacy beyond what was observed at the 1.8 milligram dose in phase two. We also observed improved adherence to treatment and low discontinuation rate, lower than placebo, which is critical to addressing a serious chronic liver disease such as MASH. Based on the strong Phase II data and based on the design and the powering of the pivotal Phase III study, we are looking forward for PEMV to continue showing benefits for MASH patients. We have announced this morning the 48-week results from the Phase II impact trial will be the subject of an oral presentation by Dr. Mazen Nuragin at the EASL conference later this month in Barcelona. This abstract for the oral presentation has been selected as the best of EASL abstract, which highlights the most noteworthy contribution to the scientific program at EASL. In addition, our presence at EASL conference will increase this year with another three posters about cardiovascular risk factors, including weight loss, NITs, and Q fibrosis. We believe that the oral presentation and the interest from the scientific community through these activities speaks to the excitement around pemvizutide. We will also have a medical affair booth and participate in many interactions with KOLs and potential investigators for the PERFORMER phase 3 trial. We look forward to engaging with the LIBER community and supporting their excitement on pemvizutide. While our near-term focus is now the execution of the PERFORMER Phase III MASH Pivotal Trial, we have another milestone approaching this year with the top-line data from the Phase II Reclaim Trial of Pembidutide in Alcohol Use Disorder expected in the third quarter. We believe the AUD population, who has a high unmet need, is particularly suited for Pembidutide therapy because of the expected GLP-1 action on alcohol cravings, the direct glucagon activity on the early liver disease, including steatosis, inflammation, and early fibrosis, and the excellent tolerability, which we have observed to date and is critical in this population. As a reminder, the RECLAIM trial is evaluating the 2.4 milligram dose of pemvigetide with a simple two-step monthly titration scheme versus placebo in 100 subjects with moderate to severe AUD. Subjects are those once weekly for 24 weeks, and the primary efficacy endpoint is the change from baseline in heavy drinking days, which are defined as five or more drinks for men and four or more drinks for women in a 24-hour period. Key secondary endpoints include zero heavy drinking days, a two-level reduction in the WHO risk drinking level, change in measures of alcohol consumption, and change in body weight and BMI. An important exploratory endpoint is the change in phosphatidyl ethanol, or PEST, which is a more objective blood-based biomarker of alcohol consumption. that represent alcohol intake over the most recent four to eight weeks. We look forward to sharing the top-line data next quarter. In addition, the restored trial in ALD evaluating pemvidutite's effect on liver-related nits, markers of alcohol consumption and body weight, is continuing to enroll, and we now expect to complete enrollment in the third quarter of this year. In summary, with a heavy focus on the execution of the PERFORMA Phase III trial, we continue advancing our clinical development program for PEMV with important milestones expected throughout the rest of this year. These efforts are integral to our long-term value creation strategy, which centers on optimizing the therapeutic potential of our balanced one-to-one glucagon GLP-1 dual agonist, PEMV-Dutide, in serious liver diseases. And with that, I will turn the call to Linda.

Thanks, Christoph, and good morning, everyone. The MASH market is evolving, as approved drugs and a number of others in late stage development represent a range of modalities that aim to address various segments of the broader MASH patient population. This reinforces our belief that as the market continues to evolve, distinct patient segments with unique needs will begin to emerge. Satisfying those needs will be a key driver of success. As Christoph mentioned, our PERC form of Phase III trial design has factored in key learnings from our Phase II data sets, and we believe this positions Pembe well for future competitiveness in the market. The potential target product profile for Pembedutide and MASH includes strong early metabolic benefits, significant improvements in inflammation and fibrosis, and quality weight loss that also helps preserve lean muscle mass, combined with a patient-friendly, simple titration that leads to a low rate of discontinuation due to GI side effects. This combination of features and resulting potential benefits resonates with HCPs and leads us to believe PEMB may provide real advantages to patients facing serious liver diseases. During our last two earnings calls, I shared key data points from market research studies we commissioned engaging healthcare professionals in both the U.S. and Europe. The feedback collected from these exercises highlighted the importance of potential key differentiating attributes for PEMBI that would influence future prescribing decisions in MASH, a highly favorable tolerability profile that does not sacrifice efficacy, and quality weight loss. First, let's discuss the highly favorable tolerability profile we've seen to date in our IMPACT trial. which did not include any dose titration. Results showed that both the 1.2 and 1.8 milligram doses of Pembe were efficacious, showing early evidence of MASH resolution and NIT-based antifibrotic effects while being well tolerated. In fact, there were fewer AE-related discontinuations in the two Pembe arms than in the placebo group. To potentially further enhance efficacy and optimize tolerability, Our PERFORMER trial design includes a simple titration schedule that begins with an active starting dose of 1.2 milligrams and escalates to either a 1.8 or 2.4 milligram dose after only one or two titration steps of four weeks. In a real-world setting, this patient-friendly, simple and quick titration could readily translate to patients remaining on treatment longer, allowing for a greater likelihood of achieving therapeutic benefit especially in a chronic condition like MASH. Now, let's compare this combination of simple titration and favorable tolerability to other therapies on the market or being evaluated for use in MASH. GLP-1-based therapies, in particular, have been associated with GI side effects that lead to discontinuations in both clinical trial and real-world settings. One competitor's Phase II trial included a titration schedule that used 12 different strengths over 20 weeks to get to the maximum dose, and at least seven steps to get to the lowest effective dose, all in a proactive attempt to manage GI-related side effects. And still, approximately one in four patients discontinued therapy due to GI side effects. In clinical practice, dropout rates are typically even higher than those in clinical trials. where patients are actively managed and encouraged to stay on treatment. From our own market research, we know that physicians are now indicating that there is an emerging unmet need for new options for patients who could not tolerate semaglutide. How can patients get the efficacy they need when tolerability is a real barrier? Shifting the discussion now to the quality of weight loss as an additional potential differentiator for PEMVI, we saw steady weight loss with our 1.8 milligram dose in our Phase II MASH trial, with no evidence of plateauing over 48 weeks. This pattern also occurred in our obesity trial, where PEMFI demonstrated less of an impact on lean muscle mass than has been reported in other GLP-1 trials. Rapid drops in weight loss have been associated with a greater negative impact on lean muscle mass. Current projected average age at diagnosis for MASH patients in the U.S. is between 55 and 60. This represents a high degree of overlap with the ages where preservation of lean muscle mass becomes a concern. Patients diagnosed with MASH and sarcopenia are at a significantly higher risk for adverse outcomes. Therefore, the importance of preserving lean muscle mass in the MASH population should not be underestimated. We naturally begin to lose lean muscle mass as we age, with an acceleration of loss around age 60. By age 70, many people have lost 25 to 30% of the muscle mass they possessed in their prime. Over time, loss of lean muscle mass and muscle weakness can lead to metabolic dysfunction, reduced mobility, difficulty performing activities of daily living, and falls and fractures. Clearly, therapies that help reduce the impact of lean muscle loss in patients with MASH are needed for this at-risk population, and we will be evaluating this in our Phase III MASH program. We continue to believe very strongly in the potential of Pembidutide to offer meaningful benefits to patients with MASH and that its potential unique attributes position it well to stand out in a commercial setting. We look forward to generating additional clinical data to support these benefits in our Phase III MASH program and to sharing additional insights from our pre-commercial work along the way. With that, I'll turn it over to Greg for the financial review.

Thanks, Linda, and good morning. Starting with the balance sheet here. A key strategic focus for the company was securing access to the capital required to successfully drive our clinical programs. And to that end, in April, we're pleased to complete an oversubscribed public offering with gross proceeds of $225 million with participation from top-tier biotech investors. And as of March 31, we reported total cash of $332 million. And on a pro forma basis, our cash position as of April 30 is is $535 million. This very strong cash position now provides us with the operating cash runway through the pro forma phase three MASH 52-week data readout expected in 2029. Now moving to our financial results for the quarter, R&D expense in Q1 2026 was $16.2 million as compared to $15.8 million for the same period prior year. The increase in R&D spend was driven primarily by the ongoing AUD and ALD trials, as well as the startup cost for the PERFORMA Phase III trial in MASH, partially offset by a decrease in expenses related to the completion of the IMPACT Phase II trial in MASH, which was ongoing in 2025. The Q1 2026 spend includes $9.5 million in direct costs related to Penn V development, of which $3.7 million was for MASH, and $4.2 million for the Phase IIs in AUD and ALD, and $1.6 million in CMC-related expenses. Q126 also included $1.2 million in total non-cash stock comp. G&A expense in Q1 2026 totaled $8.1 million as compared to $6 million for the same period in 2025. The increase in G&A primarily driven by an increase in severance costs and professional fees The first quarter 26 G&A included $2.1 million in total non-cash stock comp. The net loss for the first quarter 26 is $22.6 million or 18 cents a share compared to a net loss of $19.6 million or 26 cents per share in the first quarter of 2025. Looking ahead, we're looking forward to initiating to perform a Phase III MASH trial in the second half of the year. and top-line data readout from the Phase II AUD trial next quarter. With the stronger balance sheet providing us with the cash runway through Phase III data, we're now really focused on execution and looking forward to continuing to advance Pemba-Dutide. This concludes our prepared remarks, and I'll now turn the call back to the operator for the Q&A session. Operator?

As a reminder, if you'd like to ask a question at this time, 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 first question comes from Ellie Merle with Barclays.

Hey, guys. Congrats on all the progress, and thanks for taking the question. So you announced this morning some presentations at ESOL. Can you go into some more details on what new information we'll learn from these? Thanks.

Ellie, hi, thanks for the question. Christophe, can you take that one?

Sure. Yeah, so the different presentations we're going to bring at ESOLS are regarding some Q fibrosis, so additional evidence of early fibrosis antifibrotic effects that we had at 24 weeks on our biopsy. It's a different type of reading from AI-generated reads. We're going to have as well some look at our weight loss and potential lipid data, cardiovascular risk in this population. And obviously, very importantly, we'll have our 48-week data that we'll be sharing in this oral presentation that's been where the abstract was selected as best of easel. So we're really happy with this. It's an important contribution. to the scientific program based on their selection and we believe it is the case as well, so excited about it.

Great, thanks.

Thanks, Ellie.

Our next question comes from Roger Song with Jefferies.

Great, congrats for the quarter and then all the progress and thank you for taking the question. Since you're finalizing the Phase 3 MASH trial starting second half. And just curious, any internal analysis has been updated to the design potential for security or the sample size adjustment? So that's a question for MASH. And then for AUD, can you just elaborate on what will be the go-no-go decision criteria before you can commit more investment into the pivotal stage? Thank you.

Okay, maybe you start on the MASH. I'll take the AUD.

Sure. So on the MASH, the study is designed as an event-driven study to reach the final clinical outcome for final registration. The interim analysis is the 52 weeks based on biopsy that will support the accelerated approval and for which we're going to have those finish that trial. and having the readout in 2029. There is no other interim analysis that is planned than these two, and we are, again, very well-powered in order to reach these outcomes. And then I'll let Jerry answer the AUD.

Yes, thanks, Roger. You know, we're definitely encouraged by all the interest emerging in the AUD indication overall and definitely look forward to the readout and Good to say that we can say the readout will happen next quarter at this point. Obviously, we'll assess the data fully once we get it, and we'll look to disclose that to the market. We'll also then undertake the right conversation with the regulators, and so all of that will factor into what we think about is the potential value. If we get to a situation where we believe there's value to move ahead in with that indication, then we would definitely have a preference in that scenario to really explore non-dilutive options in terms of thinking about funding, moving that program ahead. So, again, next important step for us is to get the Phase II data readout, and that will give us some additional insight on, again, an indication where we think PEMBI can play a unique role, potentially not only the impact on drinking, but also on the direct liver benefit, which is such an important part of that disease as it progresses.

Got it. Thank you.

Thanks.

Our next question comes from Annabel Simimi with Stifel.

Hi. Thanks for taking my question. Just to follow on the AUG questions, so thank you for laying out the differentiation that you see versus semaglutide. What I'm wondering here is, given that they have recently shown some pretty meaningful data in AUD, with the addition of glucagon, are there any measurements that you're looking at for AUD that could show the benefit of the direct liver targeting that you'll have with pembidutide over Wagovi? any other things that you think that you should be incorporating into the trial or looking at the trial to further differentiate HemV from Regovi, given that Regovi might be generic by the time you come to market. And then I guess another question on AUD, in terms of the clinically meaningful endpoints, you know, you have heavy drinking days, clearly, and you also have some abstinence. Is it clear what the final endpoints should be for phase three from a regulatory perspective? I'm just curious on that. Thank you.

Okay. So, maybe, Christophe, we'll take that in order. First, the question on the differentiation and how do we see that evolving, and then second, on, you know, appropriate endpoints from a regulatory context.

Right. So, no, thank you. So, first, we're really excited to see those semaglutide data because this is clearly validating the hypothesis that permutatide has a real potential to show benefits in this population. In addition to this, as you mentioned, the glucagon part is really important. So we believe that, and we know this has been demonstrated, there has been presentation in the past conferences, scientific conferences, that these patients have early markers of liver disease, including steatosis, inflammation, and even early fibrosis. Targeting the liver is really a critical aspect for us that is something that the GLP-1 alone will not be able to achieve since there is no GLP-1 receptor in the liver. In our study, we have markers of liver healthiness that we're going to be looking at. And to your last point, we will obviously look at all the data that we will have and see how we can incorporate those differentiation factors into our phase three, into the registration program, how to do this best, because we believe here that we have, again, a product that is really well-suited for this population. The last piece that I would remind you about is the adherence to treatment to the tolerability in the population that is fairly healthy otherwise, and for which pemvigetide, if we continue to show what we've seen in our impact phase two, MASH data should be, again, having a clear advantage with that population. So that's important. Regarding the endpoints for Phase III, right now the FDA has proposed two endpoints, the zero drinking days, heavy drinking days, or a change in two steps, two levels in the WHO drinking ranking there between those. We'll explore these two, we'll see where our data will lead us and we'll have those discussions with the FDA when we reach the end of phase two meeting.

Great, thank you.

Our next question comes from Michael DeFiore with Evercore ISI.

Hi guys, thanks so much for taking my question and congrats on the progress. Two questions for me. At your December impact call, You said that there was no obvious path to reevaluate the 24-week biopsy data in an AIM mesh-like way because LiverExplorer is a different quantitative tool. That said, the easel poster now says quantitative digital pathology showed fibrosis regression at 24 weeks. So can you clarify what exactly is new in that analysis? And the second question is just given Roche's proposed acquisition of PathAI, Does that change anything in how you plan to incorporate AIM mesh assist into the phase three biopsy read process? Thank you.

Yeah, maybe I'll start with the second question first, and then Christoph can clarify. There are a lot of different AI tools, so it is a little important to track exactly which one is being used where. First, I think on the question of the acquisition by Roche Diagnostics of AIM, of PathAI. As you would imagine, the teams are working extremely closely between Altimmune and Path on the Phase 3 incorporation of the AIM MASH Assist tool. And, you know, that conversation has continued fully since the announcement, and we don't anticipate any change to the process that's already been mapped and all the planning around how execution is going to work on being the first program that will be able to incorporate the AMASH Assist tool to the pathologists in the phase three. Maybe just some clarity then, Christophe, on the Q-fibrosis data versus the AMASH Assist tool.

Again, I mean, sharing my enthusiasm, we are going to be the first registration study using that AMASH Assist. So we're looking and working with the PASSAI team really closely. So no change there. We're just moving forward. directly with the Q fibrosis so it's a little different approach that is assessing so the a mash cannot because you need to do that in the in prompting the pathologies to the reading etc going back would have some some created some internal I mean clearly some biases etc so we cannot go back to the a mash assist as you as you mentioned the Q fibrosis it's different it's It's an approach that subtracts basically the steatosis around to allow to read in a more accurate manner through the AI process just the fibrosis itself. And those data are important. We believe that our drug, pemvigetide, is decreasing MASH or leading to MASH resolution very rapidly, very early, and that could be one of the factors that makes it harder for the pathologists to identify the changes in the fibrosis as some of the features. So it's an interesting poster that we're going to be presenting, and we're really excited about showing these data and showing, again, that what we believe is that we see some very clear antifibrotic effects early, even at 24 weeks. So putting those together, it's very exciting to see what we're going to get at EZL.

Great. Thank you. Thank you.

Our next question comes from Kripa Devarakonda with Truist Securities.

Hey, guys. Thank you so much for taking my questions, and congrats on getting best of EZL. So a couple of questions on the Phase III trial design. Beyond the 52-week biopsy endpoint, I was wondering if you can provide a few more details You know, you're moving from the no titration phase two to starting with 1.2 MIG and titrating. So can you just remind us of the rationale for the strategy? And then with the inclusion of, you have both the 1.8 MIG and the 2.4 MIG arms for the primary endpoint. Can you talk a little bit about the statistical design there? Does it need to hit on both, or how does that work? Thank you.

All right. No, that's, thank you for the question. The first thing is I want to remind you about the 48-week data that shows that basically a 1.2 and 1.8 milligram dose were infectious dose. A 1.2 milligram dose had a solubility similar to placebo, and the 1.8 had a little more GI effect, but there was no titration. So we believe we have an upside that we can propose to the patient with a very single step titration that will help them just improve in tolerability. We've seen our GIAEs occurring within the first four weeks in general, so we believe that that first step will really help because of that placebo-like tolerability. So that's why we designed it that way. And then with regard to the other, each of the other part of the questions, What we have done is we've established those two arms. Our first key dose based on our phase two data is the 1.8 milligram dose. We believe it's a very efficacious dose. Our data support this, and on top of this, the tolerability and what we've seen at 48 weeks confirmed this. So that's our anchor dose, if you wish. We've seen added weight loss in the obesity program with the 2.4, And based on this, we believe that there's a potential for added efficacy. That's why we included it. However, on the powering and the statistical approach, we've taken a more conservative approach to powering the study, and we've powered on the effect size of the 1.8 milligram dose, both the 1.8 and the 2.4 arms, because clearly this is more of an exploratory approach, if you wish. where we expect added benefits for these patients. So that's how we've, we believe it's an upside on the efficacy part that we could see. And we're going to be looking at these endpoints at the end of the 52-week.

Okay, great.

Thank you so much.

Thanks, Greg.

Our next question comes from William Wood with B. Reilly Securities.

Hi. Thanks for taking our questions. So, sort of a two from us. Just curious how you're seeing the long-term treatment of patients with MASH on Pembidutide. Has there been any sort of evaluation of dose reductions or what happens when patients dose reduce or even taking less frequent dose or And is that expected to be looked at in some of your upcoming trials, maybe possibly even after your phase three reads out? And then also just a quick add-on or follow-up to your easel data that you're expecting. It looks like in the abstract of your CV presentation that we'll be getting some visceral adipose tissue data or just that. Could you just sort of confirm that we'll be getting that data in that poster, just given with what we've seen of the importance on sort of the CV benefits. Thanks.

Right. So on the dose reduction first, I mean, this is something that we've explored in our phase two. We've seen very few patients using the dose, no discontinuation. And obviously, we'll be looking at this in our phase three. we have put in place even for all the way to the 2.4, where these patients can reduce the dose. However, we are incentivizing the patients in order to stay at the most efficacious dose, which is 1.8 milligram dose, or even all the way to 2.4. So there is a whole system that is put in place to really have those efficacious dose tested. and allowing if there were any GI tolerability. We believe even with the current titration scheme that we proposed that we're going to be even able to eliminate most of those and limit really to just a few patients those aspects. So that's the upside. On the lipid and the cardiovascular risk, we'll be looking at the lipid profile. To your questions, we have shown some lipid benefits through our previous studies, and patients look at this, but we don't have like fat assessments in the poster itself.

Thank you. Thanks, William.

Our next question comes from Arabella Ng with HC Wainwright.

Hi. Thank you so much for taking the question. I was just wondering, will Performa use a pre-filter and your auto-injector? And then if it is going to use an auto-injector, have you secured a partner for that? And then just generally, are there any gating items you need to complete before you initiate the trial? Thank you so much.

So maybe I start on the last part first, and then we flip it to Christoph. As we said in the prepared remarks, and we'll stress, we're in the full startup phase on the trial. So it's about really establishing the global infrastructure, ensuring the vendors are online and ready, initiation of the trial sites, ensuring that the clinical supply chain is ready to support the initiation. So all of that activity is ongoing and the start of the trial with initiation in the second half is what we're moving towards. Christophe, maybe you take the other part.

So for the preformer phase three study, we're not using the autoinjectors. We're going to do separately a comparability type study to use the autoinjectors at launch. And that's how we've approached that aspect. We've got some good adherence with our approach right now. The phase two, we're going to continue using that approach and have the autoinjector ready for launch.

Our next question comes from Corinne Johnson with Goldman Sachs.

Hi, this is Anupam on behalf of Corinne. Maybe can you just tell about in terms of digital pathology fibrosis, how should we think about translating the outcomes based on these measures to the fibrosis improvement as it will be evaluated in the Phase III trial?

Yes, so there's two. I mean, obviously, there's the regulatory path that requires the biopsy, and that's the way regulatory agencies are looking at this. The digital pathology, you have different aspects. You have like the AMASH assist, which is a tool that assists the pathologist in reading and prompt the pathologist to the features on the biopsy slides, which is in itself should be able to decrease the variability, increase consensus between pathologists as they're all prompting to the same features, and that's one approach. The other approach is some of the things we've done in our Phase II study that we'll be continuing to look into, this liver explorer that was highly significant at 24 weeks, demonstrates the impact on fibrosis directly in a continuous manner. And the other one approach, which is this Q fibrosis that we're presenting at Eazl, that is very interesting. I think here we have a little bit of a story when you decrease the fat in the liver very rapidly, as we've seen at week 24, it becomes a little more challenging for the pathologist to read the fibrosis changes. being able to subtract it in a way that's consistent with staging of those fibrosis is very valuable. So these will be added assessments and confirming the biopsy reads from the pathologies through the M-MASH assist, but clearly in our phase three, the primary endpoint will be done on the biopsy using this AMASH Assist tool for the reading. So we'll have a whole bunch of evidence that we'll cross-reference at the end of the study at week 52 for the accelerated approval.

Okay, thank you. Our next question comes from John Wallivan with Cities.

Hey, guys. Thanks for taking the question and the updates today. Two for me. Mass trials are large and take a long time to run, but incretin trials go pretty fast. I'm wondering if you think about the pace of enrollment potentially being faster than we would expect in a mass trial because of the potential obesity benefit. And then big picture-wise, you guys talk a little bit about differentiation. We're seeing more and more triple agonists get announced. You have more data now, but do you think down the road, dual agonists get leapfrogged by the triples that are all, you know, becoming more popular and crowded as well. Thanks.

Yeah. On the first question, look, we are expecting that the weight loss benefit to your first question and the overall profile of PEMB will help. We've seen in the other trials and as you reference clearly, John, the speed of the incretin trials that typically go quickly. So we're understanding, we're building a robust study here, but we're targeting for good, efficient, effective enrollment. And the profile and the weight loss is one of the components that we think will help with that.

Yeah, no, nothing else to add. I mean, maybe the design of the study is also attractive because we have a couple of cohorts So more chances for our patients and the PIs to include their patients. So all in all, you're absolutely correct. I mean, the rate of enrollment is much higher for obesity when there's the weight loss. In addition, we have these these features in the design of the study that we developed.

John, on your second question, we are developing, and when we talk about differentiation, we always have in mind the other combinations, including the triples. Maybe, Linda, you touch on how we see the ability of PEMV to be differentiated, not just kind of with the products available today, but also with the coming years. that might be available in the future?

Yes, certainly. I think that we have an opportunity with PEMVI to focus on our attributes of being both direct acting on the liver with the glucagon and with our ratio of one-to-one GLP-1 to that. And the package of benefits that we're seeing delivered there are very competitive, even vis-a-vis the very metabolic forward, as we've seen at this point, metabolic forward triple Gs. We, the direct acting components, haven't been as defined as ours in the one-to-one ratio. And I think looking at a tolerability profile and efficacy on multiple points, our ability with our safety profile, frankly, to be used in combination with other agents if they need to, we're delivering the full package. And our titration, unlike some of these others as we've talked to, is very simple and not complex. So you see, we have... that tolerability and we have that effect on metabolic and even the opportunity to have additional weight loss. So we're seeing ourselves as a pretty fulsome, well-rounded package that can hold our own and that we see early effects, sustained effects with weight loss, maybe some more efficacy with the 2.4 even on anti-fibrotic and weight measures. So right now, until we're really seeing things that aren't based on weight loss studies, we'll keep an eye on the market, of course, But I think looking at even our quality of weight loss could be a differentiator. You're not dumping a ton of weight loss right away and leading to more muscle mass being lost. So obviously always keeping an eye forward, but confident in our ability to continue to display the differentiating benefits in our Phase III trial and associated trials to make sure we have a very solid place in the NASH landscape in the future.

Thanks, John.

Our last question comes from Andy Shea with William Blair.

Thanks for taking our question. Just a question on ADA data presentation. The other GLP-1 glucagon assets will have both the data set and also the natural data set. I'm curious about how you would interpret that data when the full results come out. And secondarily, I think you emphasized a lot during the call about the college daily profile.

Just looking at... Andy, you're cutting up. Can you repeat your initial question?

Sorry, let me just use my phone. Way better. Sorry about that. So it has to do with the GLP-1 glucagon competitive acid servodutide that's going to be presented at ADA. So I'm curious about how you would, you know, interpret there both the obesity data set and also the mass old data set without biopsy. So that's first question number one. Question number two, you mentioned about the tolerability a lot during the call. Looking back in the phase two trials that you've conducted, momentum and impact, I'm curious if you have any, you know, persistence or adherence data, you know, so for example, percentage of patients, you know, persisted throughout the trial or towards the end. That could really paint a picture of, you know, patients staying on therapy for PEMV. Thanks.

Yeah, maybe we'll start with that one because I think it's an important one, which we've talked about a bunch. We do see in the 48-week data, when we talk about the strong tolerability profile, that this adherence and the fact that such a large percent of the patients on PEMV at both doses, frankly, stayed on therapy even more than placebo. And when we talk about tolerability, we're not just talking it as a, avoidance of some side effects, but it's also being able to get to the effective dose and stay on therapy, which we know are such a large part of the important real-world treatment concerns for physicians. And that kind of leads right to your other question, which was around cervidutide and what we're seeing there. Maybe, Christophe, you want to pick that up.

Yeah, no, again, so first, I mean, in the impact moment of et cetera, we see a clear dose response in favor of of the higher doses of pembudetide where patients stay on treatment. So this is very encouraging for us, especially, I mean, on my end as a physician, I mean, in a chronic therapy setting, keeping the patients on an efficacious dose on the long term is a key aspect of what we're trying to achieve here. So, really encouraging data that we've seen here. Also, we have anecdotal evidence from some of our PIs telling us that are running different studies, also other GLP-1 or even those triple agonists, et cetera, and they are telling us that pemvidutide is a very different kind of approach for the patients and the treatment satisfaction is much different. We feel that we have some advantage here, and that's really important in that chronic setting, in MASH, in AUD, in ALD, et cetera. So these are the kind of things. On the servodutite aspect, so we've seen weight loss, they've seen weight loss similar to ours. It's been comparable. The big challenge in my mind is back to that tolerability. They had One, they needed a very long titration to get up to their efficacious dose. They even have set up some aspects where if they down titrate, you need a whole kind of new scheme to restart the patient, which is absolutely not our case. You've seen in the phase two, you can jump the patient straight into their 1.8 milligram dose without any titration. So we are in two very different scenarios here. And the discontinuation rate is almost one in four patients that is not staying on the drug. So I believe there's a couple of aspects that we have here. Cervodutide look more like GLP-1 with a little bit of glucagon. That's the A to 1 ratio. We've heard people saying just a little splash of glucagon. on top of GLP-1, and we believe that this ratio one-to-one is really important, and again, I cannot reemphasize in the chronic setting the importance of having adherence to treatment and to an efficacious dose. I mean, this is a key aspect patients will stay. I'm sure that payers will be very happy with this, but that also, we've seen it already in our study. We'll continue to look into it in the phase three of our trial.

That concludes today's question and answer session. I'd like to turn the call back to Jerry Dorso for closing remarks.

Thanks, operator. So we've made significant progress as we evolve into a late-stage company. Altimmune's focused on execution, and we're committed to further advancing our promising meaningfully differentiated liver therapy and creating long-term value for our shareholders. It's really an exciting time here, and I definitely look forward to updating you on our progress as we progress. Thanks a lot for joining today, and everybody have a great day. Take care.

This concludes today's conference call. Thank you for participating. You may now disconnect.