Altimmune (ALT) Q1 2026 Earnings Transcript

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DATE

Wednesday, May 13, 2026 at 8:30 a.m. ET

CALL PARTICIPANTS

• President and Chief Executive Officer — Jerome Durso
• Chief Medical Officer — Christophe Arbet-Engels
• Chief Commercial Officer — Linda Richardson
• Chief Financial Officer — Gregory Weaver

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TAKEAWAYS

• Cash Position -- Altimmune reported a pro forma cash balance of approximately $535 million as of April 30, following an oversubscribed public offering that generated $225 million in gross proceeds.
• R&D Expense -- Research and development expense was $16.2 million, reflecting higher costs driven by ongoing AUD and ALD trials, as well as start-up costs for the PERFORMA Phase III trial in MASH.
• Net Loss -- Net loss for the quarter was $22.6 million, with a loss per share of $0.18.
• Phase III MASH Trial Start -- The PERFORMA Phase III trial in MASH is on track to initiate patient screening and enrollment in the second half of 2026, with regulatory alignment confirmed by both the FDA and EMA.
• Regulatory Designation -- Pemvidutide was granted breakthrough therapy designation by the FDA for MASH.
• Clinical Data Milestones -- 48-week results from the Phase II IMPACT trial will be presented at EASL as a “Best of EASL” oral abstract, and three additional posters related to cardiovascular and fibrosis outcomes will be featured.
• Upcoming Data Readout -- Topline Phase II results for pemvidutide in alcohol use disorder (AUD) are expected next quarter; completion of RESTORE trial enrollment in ALD is anticipated in the third quarter of 2026.
• Tolerability and Adherence -- Fewer adverse event-related discontinuations were observed in both 1.2 mg and 1.8 mg pemvidutide Phase II arms compared to placebo, according to clinical data cited by management.
• PERFORMA Trial Design -- The Phase III trial will use a simple dose escalation scheme, beginning at 1.2 mg and escalating to 1.8 mg or 2.4 mg, specifically designed to optimize efficacy and tolerability as informed by Phase II data.
• Primary Endpoint and Interim Analyses -- PERFORMA’s interim analysis is planned at 52 weeks (biopsy-based) for accelerated approval; there are no additional interim analyses beyond the two scheduled endpoints.

SUMMARY

Altimmune (NASDAQ:ALT) strengthened its balance sheet and advanced its lead asset, pemvidutide, toward a global Phase III MASH trial, achieving regulatory alignment with both FDA and EMA. The company expects major clinical inflection points in 2026, including the imminent initiation of the PERFORMA trial and multiple data presentations at EASL. A robust cash position supports the company’s operations through the Phase III MASH readout. Management highlighted pemvidutide’s differentiated tolerability and adherence profile and noted ongoing trials in AUD and ALD with key data readouts on the near-term horizon.

• Management described the introduction of a 2.4 mg pemvidutide dose in Phase III, referencing prior obesity trial data that suggested potential for increased efficacy beyond the 1.8 mg dose.
• Chief Medical Officer Arbet-Engels said, “Q-fibrosis is 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.”
• Christophe Arbet-Engels noted, “The interim analysis is the 52 weeks based on biopsy will 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 2, and we are, again, very well powered in order to reach this outcome,”
• Altimmune confirmed that the PERFORMA Phase III trial will deploy the AIM MASH assist tool from PathAI for pathologist-assisted biopsy reading, with no changes anticipated despite Roche’s proposed acquisition of PathAI.
• Management stated that a direct glucagon component is intended to drive liver-targeted efficacy in AUD and MASH, differentiating pemvidutide from GLP-1-only therapies.
• The company stated that the Phase III trial statistical powering is based on the 1.8 mg dose, with the 2.4 mg arm added for potential upside in efficacy.

INDUSTRY GLOSSARY

• MASH: Metabolic dysfunction–associated steatohepatitis, formerly known as NASH, a chronic liver disease characterized by inflammation and fibrosis.
• AIM MASH assist tool: An AI-based digital pathology platform used to standardize and support biopsy readouts in liver disease clinical trials.
• Q-fibrosis: An AI-driven digital pathology approach focusing on quantitative measurement of liver fibrosis by subtracting hepatic steatosis from image analysis.
• CRO: Contract research organization, an outsourced partner managing clinical trial operations.
• UPORT structure: Altimmune’s proprietary technology incorporated into pemvidutide intended to slow absorption and potentially improve drug tolerability.

Full Conference Call Transcript

Jerry Durso, our President and Chief Executive Officer; Dr. Christophe Arbet-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. 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. 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.

Jerome 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 resulted in a cash balance of approximately $535 million as of April 30. We now have the financial resources to fully fund the company through our Phase III MASH 52-week data readout, which is expected in 2021.

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, and 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 balance 1-1 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 UPORT 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 the highly favorable tolerability profile that does not sacrifice efficacy and quality weight loss. These are 2 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, and 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, and the final study protocol is aligned with the feedback we've received from EMA.

So Altimmune is fully focused on the start-up phase for a large global Phase III trial. We're moving quickly, partnering with the CRO who brings deep now 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, and then we look forward to initiating patient screening. While we have significant focus on our lead MASH program and initiating the PERFORMA study, we're also progressing on 2 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 had 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 proforma 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.

Christophe Arbet-Engels: Thank you, Jerry. The start-up 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 submissions 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 the 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 from for large 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 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 3 posters about cardiovascular risk factors, including weight loss, NIT and [ Q-fibrosis ]. 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 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 [ actions ] 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 pemvidutide with a simple 2-stack mostly titration scheme versus placebo in 100 subjects 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 0 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 end point is the change in phosphatidylethanol or [ PET ], which is a more objective blood-based biomarker of alcohol consumption that represents alcohol intake over the most recent 4 to 8 weeks. We look forward to sharing the top line data next quarter. In addition, the RESTORE trial in AUD evaluating pemvidutide effect on liver-related NIT, 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 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 1:1 glucagon GLP-1 [ 0 ] agonist, pemvidutide in serious liver diseases. And with that, I will turn the call to Linda.

Linda Richardson: 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 PERFORMA 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 the 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 pending may provide real advantages to patients facing serious liver disease. During our last 2 earnings calls, I shared key data points from market research studies we commissioned engaging health care 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 antifibrotic effects while being well tolerated. In fact, there were fewer AE-related discontinuations in the 2 pemvi arms than in the placebo group.

To potentially further enhance efficacy and optimize tolerability, our PERFORMA trial design includes a simple titration schedule that begins with an active starting dose of 1.2 milligrams and escalates to either 1.8 or 2.4 milligram dose after only 1 or 2 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. 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 7 steps to get to the lowest effective dose, all with a proactive attempt to manage GI-related side effects. And 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. Just in 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 that 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 of diagnosis for match patients in the U.S. is between 55 and 60. This represents a high degree of overlap with the agents 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 helped 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 is potentially 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.

Gregory Weaver: 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 was $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. 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 start-up costs for the pro forma 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 of direct costs related to pemvi 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 also included $1.2 million in total noncash stock comp. G&A 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 noncash stock comp. The net loss for the first quarter of '26 was $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 pro forma 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 a 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?

Operator: [Operator Instructions] Our first question comes from Ellie Merle with Barclays.

Eliana Merle: Congrats on all the progress. So you announced this morning some presentations at EASL. Can you go into some more details on what new information we'll learn from these?

Jerome Durso: Ellie, thanks for the question. Christophe, can you take that one?

Christophe Arbet-Engels: Sure. Yes. So the different presentation we're going to bring at EASL are regarding our some [ Q-fibrosis ]. So additional evidence of early fibrosis, antifibrotic effect that we had at 24 weeks on our biopsy. It's a different type of reading from AI-generated [ reading ]. We're going to have as well some look at our weight loss and potential lipid data cardiovascular risk in that is 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 EASL. 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.

Operator: Our next question comes from Roger Song with Jefferies.

Jiale Song: Great. Congrats for the quarter and then all the progress. Since you're finalizing the Phase III MASH trial starting in the second half, I'm just curious any interim 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 [ turnover ] decision criteria before you can commit more investment into the pivotal stage.

Jerome Durso: Okay. Maybe you start on the MASH, I'll take the AUD.

Christophe Arbet-Engels: 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 will 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 2, and we are, again, very well powered in order to reach this outcome, and then I'll let Jerry answer the AUD.

Jerome Durso: Yes. Thanks, Roger. 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, with that indication, then we would definitely have a preference in that scenario to really explore nondilutive 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 it. 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.

Operator: Our next question comes from Annabel Samimy with Stifel.

Annabel Samimy: Just a follow on the AUD questions. So thank you for laying out the differentiation on the [ ECE ] 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. And then I guess another question on AUD.

In terms of the clinically meaningful endpoint, you have heavy drinking days, clearly, and you also have some accidents. Is it clear what the final endpoint should be for Phase III from a regulatory perspective? Just curious on that.

Jerome Durso: 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 appropriate endpoints from a regulatory context.

Christophe Arbet-Engels: Right. So no, thank you. So first, -- we are really excited to see those semaglutide data because this is clearly validating the hypothesis that pemvidutide is 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. So 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 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 of the tolerability in a population that is fairly healthy otherwise.

And for which pemvidutide, 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. So that's important. Regarding the end points. For Phase III, right now, the FDA has proposed to 2 end points, the 0 drinking days, heavy drinking days or a change in 2 steps, 2 levels in the WHO drinking ranking there between those. So we'll explore this, too. We'll see how -- where our data will lead us, and we'll have those discussions with the FDA when we reach the end of Phase II [ mid ].

Operator: Our next question comes from Michael DiFiore with Evercore ISI.

Michael DiFiore: 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 MASH-like way because LiverExplore is a different quantitative tool. That said, the EASL 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 MASH assist into the Phase III biopsy read process?

Jerome Durso: Yes. 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 with what we were -- exactly which one is being used there. 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 assist tool.

And 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 we'll be able to incorporate the AIM MASH assist tool to the pathologist in the Phase III. Maybe just some clarity then Christophe on the Q-fibrosis data versus the AIM MASH assist tool.

Christophe Arbet-Engels: Again, I mean, sharing my enthusiasm, we are going to be the first registration study using that AIM MASH assist so we are looking and working with the PathAI team really closely. So no change there. We are just moving forward directly. With the Q-fibrosis, so it's a little different approach that is assessing -- so the AIM MASH cannot because you need to do that in prompting the pathologists to the reading, et cetera, going back, we'll have some created some internal -- I mean clearly some biases, et cetera. So we cannot go back to the AIM MASH assist as you mentioned. The Q-fibrosis is 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. And 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 factors that makes it harder for the pathologist to identify the changes in the fibroses with some of the features. So it's an interesting poster that we're going to 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 antifibrotic effect early even at 24 weeks.

So putting those together, it's very exciting to see what we're going to get at EASL.

Operator: Our next question comes from Kripa Devarakonda with Truist Securities.

Srikripa Devarakonda: Congrats on getting Best of EASL. 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 bit more details. You're moving from the new titration Phase II to starting with 1.2 mg and titrating. So can you just remind us for the -- of the rationale for the strategy, and 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 get on both or how does that work?

Jerome Durso: No, that's -- thank you for the questions. The first thing is I want to remind you about the 48-week data that shows that basically 1.2 and 1.8 milligram dose were able to [ issue those ] or 1.2 milligram dose had a tolerability similar to placebo and 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 patients with a very single step titration that will help them just improve in tolerability. We've seen our GIAEs occurring within the first 4 weeks max -- in general. So we believe that, that first step will really help because of that placebo like tolerability.

So that's why we design it that way. And then with regard to the other, each of the other part of the question, what we have done is we've established those 2 arms. 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 supports this. And on top of this, the tolerability and what we've seen at 48 weeks confirm 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 is 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 [ efficacy ] side of the 1.8 milligram dose, both the 1.8 and the 2.4 millig 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 the upside on the efficacy part that we could see, and we're going to be looking at these end points at the end of the 52 weeks.

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

William Wood: All right. Sort of two 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 -- and is that expected to be looked at in some of your upcoming trials, maybe possibly even after your Phase III reads out. And then also just a quick add-on or a 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 we'll be getting that data in that bolster just given with what we've seen on the importance on sort of the CV benefits.

Jerome Durso: Right. So 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 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. So there is a whole system that is put in place to really have those efficacious doses 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 limits 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 our previous studies and patients look at this, but [ we don't have like fact ] assessments in the poster itself.

Operator: Our next question comes from Arabelle Ng with H.C. Wainright.

Unknown Analyst: I was just wondering will PERFORMA used a [ prefilter in your ] auto injector. And then if it is given as 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?

Jerome Durso: So maybe I'd 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 start-up 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 and 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'll take the other parts.

Christophe Arbet-Engels: So 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. And that's how we've approached that aspect. We've got some good adherence with our approach right now to the Phase II. So we're going to continue using that approach and have the auto injector ready for launch.

Operator: Our next question comes from [ Colleen Johnson ] with Goldman Sachs.

Anupam Damani: This is Anupam on behalf of [ Colleen ]. 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?

Jerome Durso: Yes. So there's 2 -- 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 AIM MASH asset, which is a tool that assists the pathologists in reading and from 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 all come into 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 LiverExplorer that was highly significant at 24 weeks, demonstrates the impact on fibrosis directly in a continuous manner. And the other one approach, which is the Q-fibrosis 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 pathologists to read the fibrosis changes. And so being able to subtract it in a way that's consistent with staging of those fibrosis is very valuable.

So these will be added assessment and confirming the biopsy read from the pathologies through the MASH assist. But clearly, in our Phase III, the primary endpoint will be done on the biopsy using this AIM MASH tool for the reading. So we'll have a whole a bunch of evidence that we'll cross reference at the end of the study at week 52 for the accelerated approval.

Operator: Our next question comes from Jon Wolleben from Citizens.

Jonathan Wolleben: Two for me, MASH trials are large and take a long time to run but increase in trials go pretty fast. I'm wondering if you think about the pace of enrollment potentially being faster than we expect the MASH trial because of the potential DC benefit. And then big picture wise, you talk a little bit about differentiation. We're seeing more and more triple agonist get announced. You have more data now, but do you think down the road, dual agonist [indiscernible] by the triples that are all becoming more popular and crowded as well.

Jerome Durso: Yes. On the first question, look, we are expecting that the weight loss benefit to your first question and the overall profile of pemvi will help. We've seen in the other trials. And as you referenced clearly, Jon, the other -- the speed of the [ incretin ] trials that typically go quickly. So we're understanding, we're building a robust study here and what 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.

Christophe Arbet-Engels: Yes. 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, they're absolutely correct. I mean the rate of enrollment is much higher for obesity when there is the weight class. In addition, we have these features in the design of the study that...

Jerome Durso: 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 triples, maybe, Linda, you touch on how we see the ability of pemvi 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.

Linda Richardson: Yes. Certainly, I think that we have an opportunity with pemvi to focus on our attributes of being both direct acting on a liver with a glucagon and with our ratio of 1:1 GLP-1 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. The direct-acting components haven't been as defined as ours in the 1:1 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 that 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 antifibrotic and weight measures.

So right now, until we're really seeing things that aren't based on weight loss studies really want to -- 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 then 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 of our Phase III trial and associated trials to make sure we have a very solid place in the MASH landscape in the future.

Operator: Our last question comes from Andy Hsieh with William Blair.

Tsan-Yu Hsieh: Just a question on [indiscernible] data presentation. The other GLP-1 glucagon assets. So really [indiscernible] will have both in [ 8%, 8% and also the capital data set ]. So curious about how you would [indiscernible] [ treat data with ] the core results come out. Secondarily, [indiscernible] of titillate profile is looking at...

Jerome Durso: Andy, you're cutting up. Can you repeat your initial question.

Tsan-Yu Hsieh: Sorry, let me [indiscernible] my phone.

Linda Richardson: [indiscernible] better.

Tsan-Yu Hsieh: Sorry about that. So it has to do with the GLP-1 glucagon competitive assets [indiscernible], that's going to be presented at ADA. So I'm curious about how you would interpret their both the obesity data set and also the [ muscle ] 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 II trials that you've conducted MOMENTUM and IMPACT. I'm curious if you have any persistence or adherence data. So for example, percentage of patients persisted throughout the trial or towards the end, that could really paint a picture of patients staying on therapy for pemvi.

Jerome Durso: Yes. 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 pemvi at both doses, frankly, stayed on therapy even more than placebo. And when we talk about tolerability, we're not just talking it as an 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 survodutide and what we're seeing there. Maybe, Christophe, you want to pick that up?

Christophe Arbet-Engels: Yes. No, again, so first, I mean, in the impact the moment of, et cetera, we see a clear dose response in favor of the higher doses of pemvidutide 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 an total evidence from some of our PIs telling us that are running different studies also other GLP-1 or even those 3 [ coagonist ], 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. So 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 survodutide aspect, so we've seen weight loss similar to our s. It's been comparable. The big challenge in my mind is back to that tolerability. They had one -- I mean, first, they needed a very long titration to get up to the 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 I you can jump the patients treat into their 1.8 milligram dose without any titration. So we are in 2 very different scenarios here, and the discontinuation rate is almost 1 in 4 patients that is not staying on the drug. So I [ don't ] believe there's a couple of aspects that we that we have here, survodutide look more like GLP-1 with a little bit of glucagon. That's the [ 8:1 ] ratio.

We've heard people saying just a little splash of glucagon on top of GLP-1. And we believe that this ratio 1:1 is important. And again, I cannot reemphasize in the chronic setting the importance of having adherence to treatment in to an efficacies. I mean this is a key aspect. Patients will stay. I'm sure that payers will be very happy with this. But that also -- that -- we've seen it already in our study. We'll continue to look into it in the Phase III PERFORMA trial.

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

Jerome Durso: Thanks, operator. So we've made significant progress as we evolve into a late-stage company. Altimmune is 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.

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

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