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Good morning, ladies and gentlemen, and welcome to the Altimmune first quarter 2026 financial results conference call. At this time, all participants are on 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 11 on your telephone. You will 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'll now introduce your host for today's conference call, Richie Sinay, Vice President of Investor Relations. Richie, you may begin.

Thank you, operator. 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 will hear from Jerome Durso, our President and Chief Executive Officer; Dr. Christophe Arbet-Engels, Chief Medical Officer; Linda M. 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.

Altimmune 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 13, 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 pemvidutide 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 Altimmune. 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 thirtieth. We now have the financial resources to fully fund the company through our phase III 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 pemvidutide and represents another key step towards bringing pemvi to patients. We're entering a new phase for the company with the right team in place and a very strong balance sheet. We're now focused on execution and believe we're well-positioned to successfully execute our strategy.

We believe that pemvidutide 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 EuPort 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 pemvidutide based on our clinical trials to date.

As the MASH market continues to evolve, there remains a significant unmet need. We believe pemvi has the potential to offer a differentiated profile for patients. Furthermore, the potential of pemvi 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 III study in MASH in the second half of this year. The MASH phase III 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. The final study protocol is aligned with the feedback we've received from EMA. Altimmune is fully focused on the startup phase for a large global phase III trial.

We're moving quickly, partnering with a CRO who brings deep know-how in the MASH phase III space. The Altimmune team is working closely with them, and we're progressing to activate the most experienced trial sites. We'll look forward to initiating patient screening. While we have significant focus on our lead MASH program in initiating the PERFORMA 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 II 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 to complete enrollment of the RESTORE trial in the third quarter of this year. pemvidutide 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 runway through the top-line readout of our PERFORMA phase III MASH trial, we're now laser-focused on execution. We're moving with urgency on bringing pemvi 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 Christophe for a clinical update.

Thank you, Jerry. The startup activities for the PERFORMA 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 III 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 III preparation.

This is an important milestone in our global development strategy as the data from the PERFORMA 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 milligram. We will introduce the 2.4 milligram 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 II. 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 pemvi 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 Noureddin at the EASL conference later this month in Barcelona. This abstract for the oral presentation has been selected as a best of EASL abstract, which highlight 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, NIT, and qFibrosis. We believe that the oral presentation and the interest from the scientific community through these activities speaks to the excitement around pemvidutide.

We will also have a medical affair booth and participate in many interactions with KOLs and potential investigators for the PERFORMA phase III trial. We look forward to engaging with the liver community and supporting their excitement on pemvidutide. While our near-term focus is now the execution of the PERFORMA phase III MASH pivotal trial, we have another milestone approaching this year with the top-line data from the phase II RECLAIM trial of pemvidutide in alcohol use disorder expected in the 3rd quarter. We believe the AUD population, who has a high unmet need, is particularly suited for pemvidutide 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 mg dose of pemvidutide with a simple 2-step monthly titration scheme versus placebo in 100 subject with moderate to severe AUD. Subjects are dosed once weekly for 24 weeks, and the primary efficacy endpoint is the change from baseline in heavy drinking days, which are defined as 5 or more drinks for men and 4 or more drinks for women in a 24-hour period. Key secondary endpoints include zero heavy drinking days, a 2-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 phosphatidylethanol, or PEth, which is a more objective blood-based biomarker of alcohol consumption that represents alcohol intake over the most recent 4-8 weeks. We look forward to sharing the top-line data next quarter.

In addition, the RESTORE trial in ALD evaluating pemvidutide's effect on liver-related NAS, markers of alcohol consumption, and body weight is continuing to enroll. We now expect to complete enrollment in the 3rd 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 pemvi 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 1-to-1 glucagon GLP-1 dual agonist, pemvidutide, in serious liver diseases. With that, I will turn the call to Linda.

Thanks, Christophe, 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 Christophe mentioned, our IMPACT Phase III trial design has factored in key learnings from our Phase II data sets, and we believe this positions pemvi well for future competitiveness in the market.

The potential target product profile for pemvidutide in 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 pemvi 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 pemvi 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 pemvi were efficacious, showing early evidence of MASH resolution and NIT-based anti-fibrotic effects while being well-tolerated. In fact, there were fewer AE-related discontinuations in the two pemvi arms than in the placebo group. To potentially further enhance efficacy and optimize tolerability, our IMPACT 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 4 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. 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. Still, approximately 1 in 4 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 pemvi 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%-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 pemvidutide 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. 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. 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. 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 $535 million. This very strong cash position now provides us with the operating cash runway through the pro forma Phase III MASH 52-week data readout expected in 2029. 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 start-up 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 pemvidutide 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. Q1 2026 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 2026 G&A included $2.1 million in total non-cash stock comp. The net loss for the first quarter 2026 is $22.6 million or $0.18 a share, compared to a net loss of $19.6 million or $0.26 per share in the first quarter of 2025. Looking ahead, we're looking forward to initiating the PERFORMA 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 pemvidutide. 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 one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Our first question comes from Ellie Merle with Barclays.

Hey, guys. Congrats on all the progress, and thanks for taking the question. You announced this morning some presentations at EASL. 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. The different presentations we're going to bring at EASL are regarding our qFibrosis, 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 read. We're going to have as well some look at our weight loss and potential lipid data, cardiovascular risk in this population. 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 EASL. We're really happy with this. It's an important contribution to the scientific program based on their selection, we believe it is the case as well. Excited about it.

Great. Thanks.

Thanks, Ellie.

Our next question comes from Roger Song with Jefferies.

Great. Congrats for the quarter and all the progress, and thank you for taking the question. Since you're finalizing the phase III MASH trial starting second half, I'm just curious, you know, interim analysis has been updated to the design, potential for futility or the sample size adjustment. That's a question for MASH. Then for AUD, you know, 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.

Right.

On the MASH. I'll take the AUD.

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 having to read out 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 outcome. I'll let Jerry answer the AUD.

Yes. Thanks, Roger Song. You know, we're definitely encouraged by all the interest emerging in the AUD indication overall and definitely look forward to the readout and, you know, 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, you know, then undertake the right conversation with the regulators. All of that will factor into what we think about is the potential value.

If we get to a situation where, you know, we believe there's value to move ahead 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. Again, next important step for us is to get the phase II data readout, and that'll give us some additional insight on, again, an indication where we think pemvi 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 Samimy with Stifel.

Hi. Thanks for taking my question. Just to follow on the AUD questions. 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 pemvidutide over Wegovy? Any other things that you think that you should be incorporating into the trial or looking at the trial to further differentiate pemvi from Wegovy, given that Wegovy might be generic by the time you come to market? 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 endpoint should be for phase III from a regulatory perspective? I'm just curious on that. Thank you.

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

No, thank you. First, we're really excited to see those semaglutide data because this is clearly validating the hypothesis that pemvidutide has a real potential to show benefits in this population. In addition to this, as you mentioned, the glucagon part is really important. 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 gonna be looking at.

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 III, 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 pemvidutide, if we continue to show what we've seen in our IMPACT phase II MASH data, should be again having a clear advantage with that population.

That's important. Regarding the endpoints, for phase III, right now, the FDA has proposed 2 endpoints, the zero drinking days, heavy drinking days, or a change in 2 steps, 2 levels in the WHO drinking ranking between those. We'll explore these 2. 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 II meeting.

Great. Thank you.

Our next question comes from Michael DiFiore with Evercore ISI.

Hi, guys. Thanks so much for taking my question, congrats on the progress. Two questions from me. At your December IMPACT call, you said that there was no obvious path to reevaluate the 24-week biopsy data in an AIM-MASH-like way because Liver Explore is a different quantitative tool. That said, the EASL poster now says quantitative digital pathology showed fibrosis regression at 24 weeks. Can you clarify what exactly is new in that analysis? The second question is just given Roche's proposed acquisition of PathAI, does that change anything in how you plan to incorporate AIM-MASH AI Assist into the phase III biopsy read process? Thank you.

Maybe I'll start with the second question first, and then Christophe 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 PathAI. As you would imagine, the teams are working extremely closely between Altimmune and Path on the phase III incorporation of the AIM-MASH AI Assist.

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 gonna work on being the first program that will be able to incorporate the AIM-MASH AI Assist tool to the pathologists in the phase III.

Right.

Maybe just some clarity then, Christophe, on the qFibrosis data versus the AIM-MASH AI Assist?

Yeah. Again, I mean, sharing my enthusiasm, we are gonna be the first registration study using that AIM-MASH AI Assist. We're looking and working with the PathAI team really closely. No change there. We're just moving forward directly. With the qFibrosis, it's a little different approach that is assessing. The AIM-MASH cannot because you need to do that in the, in prompting the pathologist to the reading, et cetera. Going back, we'd have some created, some internal, I mean, clearly some biases, et cetera. We cannot go back to the AIM-MASH AI Assist as you mentioned. The qFibrosis, it's different. It's an approach that subtract basically the steatosis around to allow to read in a more accurate manner through the AI process, just the fibrosis itself.

Those data are important. We believe that our drug, pemvidutide, is decreasing MASH or leading to MASH resolution very rapidly, very early, and that could be one of the factor that makes it harder for the pathologist to identify the changes in the fibrosis or some of the features. It's an interesting poster that we're gonna be presenting, and we're really excited about showing this data and showing again that what we believe is that we see some very clear anti-fibrotic effects early, even at 24 weeks. Putting those together, it's very exciting to see what we're gonna get at EASL.

Great. Thank you. Thank you.

Our next question comes from Srikripa Devarakonda with Truist Securities.

Hey, guys. Thank you so much for taking my questions and congrats on getting accepted to EASL. 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 II to starting with 1.2 mg and titrating. Can you just remind us for the rationale for the strategy? Then with the inclusion of You have both the 1.8 mg and the 2.4 mg 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 questions. The first thing is I wanna remind you about the 48 week data that shows that basically our 1.2 mg and 1.8 mg dose were efficient dose. Our 1.2 mg dose had a tolerability similar to placebo, and the 1.8 had a little more GI effect, but there was no titration. 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 GI AEs occurring within the first 4 weeks max in general. We believe that that first step will really help because of that placebo-like tolerability. That's, that's why we designed it that way.

With regard to the other part of the questions. What we have done is we've established those two arm. Our first key dose based on our phase II 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 confirm this. That's our anchor dose, if you wish. We've seen added weight loss in the obesity program with the 2.4, 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 milli arms. Because clearly this is more of an exploratory approach, if you wish, where we expect added benefits for these patients. That's how we've, we believe it's an upside on the efficacy part that we could see. And we're gonna be looking at these at these endpoints at the end of the 52-week.

Okay, great. Thank you so much.

Thanks, Kripa.

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

Hi. Thanks for taking our questions. Sort of a 2 from us. Just curious how you're seeing the long-term treatment of patients with MASH on pemvidutide. Has there been any sort of evaluation of dose reductions or what happens when patients dose reduce or even taking less frequent dose or is that expected to be looked at in some of your upcoming trials, maybe possibly even after your phase III reads out? Then also just a quick add-on or follow-up to your EASL 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 on the importance on sort of the CV benefits? Thanks.

Right. On the dose reduction first, I mean, this is something that we've explored in our phase II. We've seen very few patients reducing the dose, no discontinuation, and obviously we'll be looking at this and in our phase III. 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 that 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. There's 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 propose, that we're gonna be even able to eliminate most of dose and limit really to just a few patient dose aspects. That's the upside. On the lipid and the cardiovascular risk, we'll be looking at lipid profile. To your questions, we have shown some lipid benefits through our previous studies and patient 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 H.C. Wainwright.

Hi. Thank you so much for taking the question. I was just wondering, will PERFORMA use a pre-filled syringe or auto-injector? If it is gonna use an auto-injector, have you secured a partner for that? Just generally, are there any gating items you need to complete before you initiate the trial? Thank you so much.

Maybe I start on the last part first, and then we flip it to Christophe. As we said in the prepared remarks, and we'll stress, we're in the full startup phase on the trial. 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. 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-

Yeah.

The other parts.

For the PERFORMA phase III study, we're not using the auto-injectors. We're going to do separately a comparability type study to use the auto-injectors at launch. That's how we've approached that aspect. We've got some good adherence with our approach right now from the phase II. We're gonna continue using that approach and have the auto-injector ready for launch.

Thanks, Arabella.

Our next question comes from Corinne Jenkins 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. I mean, obviously, there's the two 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 AIM-MASH AI Assist, which is a tool that assists the pathologists in reading and prompt the pathologists 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 prompted to the same features, 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 Explore that was highly significant at 24 week, demonstrates the impact on fibrosis directly in a continuous manner.

The other one approach, which is this qFibrosis that we're presenting at EASL 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. These will be added assessments and confirming the biopsy read from the pathology through the AIM-MASH AI Assist. Clearly in our phase III, the primary endpoint will be done on the biopsy using this AIM-MASH AI Assist tool for the reading.

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 Jon Wolleben with Citizens.

Hey, guys. Thanks for taking the question and the updates today. 2 for me. You know, MASH 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 expect in a MASH trial because of the potential obesity benefit. 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 referenced clearly, Jon, the other the speed of incretin trials that typically go quickly. We're understanding, we're building a robust study here but we're targeting for good, efficient, effective enrollment. The profile and the weight loss is one of the components that we think will help with that.

No, I Nothing else to add. I mean, maybe the design of the study is also attractive 'cause we have a couple of cohorts, so more chances for our patients and the PIs to include their patients. All in all, you're absolutely correct. I mean, the rate of enrollment is much higher for obesity when there is the weight loss. In addition, we have these features in the design of the study that will help

Yeah. Jon, on your second question, we are developing and then when we talk about differentiation, we always have in mind the other combinations, including the triple G. Maybe Linda, you touch on how we see the ability of pemvidutide to be differentiated, not just kind of in with the products available today, but also with the coming therapies that might be available in the future.

Yeah. Certainly, I think that we have an opportunity with PEMB to focus on our attributes of being both direct acting on the liver with the glucagon and with our ratio of 1-to-1 GLP-1 to that. 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 G. We the direct acting components haven't been as defined as ours in the 1-to-1 ratio. 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.

You see, you know, we have that tolerability, and we have that effect on metabolic and even the opportunity to have additional weight loss. We're seeing ourselves as a pretty fulsome, well-rounded package that can hold our own and that we see, you know, early effects, sustained effects with weight loss, maybe some more efficacy with the 2.4 even on anti-fibrotic and weight measures. Right now, until we're really seeing things that aren't based on weight loss studies, really wanna, you know, 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.

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, you know, make sure we have a very solid place in the MASH landscape in the future.

Thanks, Jon.

Our last question comes from Andy Hsieh with William Blair.

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

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

Sorry, let me just use my phone.

Way better.

Sorry about that. It has to do with the GLP-1 glucagon competitive assets or survodutide that's going to be presented at ADA. I'm curious about how you would, you know, interpret their both the obesity data set and also the MASLD data set without biopsy. That's first question 1. Question 2, you mentioned about the tolerability a lot during the call. Looking back in the phase II trials that you've conducted, MOMENTUM and IMPACT, I'm curious if you have any, you know, persistence or adherence data. You know, 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 pemvi. 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 % of the patients on pemvi at both doses, frankly, stayed on therapy even more than placebo. 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. That kind of leads right to your other question, which was around survodutide and what we're seeing there.

Maybe, Christophe, you wanna pick that up.

Yeah, no. Again, first, I mean, in the IMPACT, MOMENTUM, et cetera, we see a clear dose response in favor of the higher doses of pemvidutide where patients stay on treatment. This is very encouraging for us, especially, I mean, on my, 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. 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.

They are telling us that pemvidutide is a very different kind of approach for the patients, and the treatment satisfaction is much, it's 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. These are the kind of things. On the survodutide aspect, 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. I mean, first, 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 patients, which is absolutely not our case.

You've seen in the phase II, you can jump the patients straight into their 1.8 milligram dose without any titration. We are in two very different scenarios here. The discontinuation rate is almost 1 in 4 patients that is not staying on the drug. I do believe there's a couple of aspects that we have here. Survodutide look more like GLP-1 with a little bit of glucagon. That's the 8 to 1 ratio. We've heard people saying just a little splash of glucagon on top of GLP-1. We believe that this ratio 1 to 1 is really important. Again, I cannot reemphasize in a chronic setting the importance of having adherence to treatment into an efficacious dose. I mean, this is a key aspect. Patients will stay.

I'm sure that payers will be very happy with this. That we've seen it already in our study. We'll continue to look into it in the phase III PERFORMA trial.

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

Thanks, operator. 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.