Altimmune Q1 2026 Earnings Call: Complete Transcript

On Wednesday, Altimmune (NASDAQ:ALT) discussed first-quarter financial results during its earnings call. The full transcript is provided below. This transcript is brought to you by Benzinga APIs. For real-time access to our entire catalog, please visit https://www.benzinga.com/apis/ for a consultation. View the webcast at https://edge.media-server.com/mmc/p/fpkn4a66/ Summary Altimmune reported a cash balance of approximately $535 million, boosting financial resources through a successful public offering. The company is advancing its lead program, Pemadutide, with plans to initiate a global Phase 3 trial for MASH in the second half of the year, supported by a strong balance sheet. Recent market research highlights Pemadutide's potential differentiators, such as favorable tolerability and quality weight loss, which are anticipated to drive prescribing in the evolving MASH market. The company aims to report top-line data from its Phase 2 trial in Alcohol Use Disorder next quarter and expects to complete enrollment for the RESTORE trial in ALD by the third quarter. Management emphasized the strategic importance of maintaining patient adherence to treatment and is focused on execution with a strong team in place. Full Transcript OPERATOR Good morning ladies and gentlemen and welcome to the Altamoon First Quarter 2026 Financial Results Conference call. At this time, all participants are in a listen only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised to withdraw your question. Please press star 11 again. As a reminder, this call is being recorded. I'll now introduce your host for today's conference call, Louis Sinne, Vice President of Investor Relations. Louis, you may begin. Louis Sinne (Vice President of Investor Relations) Thank you Operator and good morning everyone. Thank you for joining us for Altimmune's first quarter 2026 financial results and Business Update call. On today's call, you'll hear from Jerry Durso, our President and Chief Executive Officer, Dr. Christoph Arvid 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 and 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. Altimune 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. Jerry Durso (President and Chief Executive Officer) 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 Pemadutide 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 Altimune. We've also remained focused on strengthening our financial foundation. Importantly, in April we completed an oversubscribed public offering resulting in $225 million in gross proceeds. The proceeds from the April offering, along with our existing funds, results in a cash balance of approximately $535 million as of April 30th. We now have the financial resources to fully fund the company through our phase 3 MASH 52 week data readout which is expected in 2029. This financing highlights the confidence and the conviction of participating top tier biotech investors in the potential of 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 pemadutide 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 GLP1 in a single molecule achieved with Pembi makes it potentially well suited for the liver conditions we're targeting. Additionally, pembi incorporates our proprietary UPORT structure 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 pemadutide 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 three study in MASH in the second half of this year. The MASH Phase three trial will be called the PERFORMA Trial Trial. We've now finalized the study protocol and submitted that to the FDA as part of the standard process, we've also completed the scientific advice process in Europe and the final study protocol is aligned with the feedback we've received from ema. So altimmune is fully focused on the startup phase for a large global Phase three trial. We're moving quickly, partnering with the CRO who brings deep know how in the MASH Phase 3 space. The Altimmune team is working closely with them and we're progressing to activate the most experienced trial sites and then would look forward to initiating patient screening. While we have significant focus on our Lead Match program in initiating the performance study, we're also progressing on two additional indications. First, in AUD, an area of high unmet need, we remain on track to report top line data from our Phase two trial next quarter. We remain encouraged by the strong scientific interest in this indication and look forward to the data readout in ALD. We now expect 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 3 match 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 Christoph for a clinical update. Christoph Arvid Engels Thank you Jerry. The startup activities for the PERFORMA Phase 3 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 3 trial design with both FDA and now EMA. As we expected, feedback received from EMA validated our planned trial design and represented the final regulatory step in our Phase three preparation. This is an important milestone in our global development strategy as the data from the Performer Phase three trial will form the basis for regulatory submission in multiple regions. Importantly, we achieved strong efficacy results at both 24 and 48 weeks and in the Phase 2 IMPACT trial, particularly at 1.8 milligrams. We will introduce the 2.4 milligram pemvedutide dose in Phase 3, which has achieved additional weight loss in a previous obesity study and could potentially show increased liver efficacy beyond what was observed at the 1.8mg dose in phase two. We also observed improved adherence to treatment and low discontinuation rate lower than placebo, which is critical to addressing a serious chronic liver disease such as mash. Based on the strong phase 2 data and based on the design and the powering of the pivotal phase 3 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 2 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 highlights the most noteworthy contribution to the scientific program at EASL. In addition, our presence at EASL conference will increase this year with another three posters about cardiovascular risk factors including weight loss, NITS and Q fibrosis. We believe that the oral presentation and the interest from the scientific community through these activities speaks to the excitement around Pemvidutide. We will also have a medical affair booth and participate in many interactions with KOLs and potential investigators for the PERFORMA Trial Phase 3 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 3 match pivotal trial, we have another milestone approaching this year with the top line Data from the phase 2 reclaimed trial of penvedutide in Alcohol use disorder expected in the third 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 RECLAIMED trial trial is evaluating the 2.4 milligram dose of pemvedutide with a simple two step monthly titration scheme versus placebo in hundred 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 five or more drinks for men and four or more drinks for women in a 24 hour period. Key secondary endpoints include zero heavy drinking days, a two level reduction in the WHO risk drinking level, change in measures of alcohol consumption and change in body weight and bmi. An important exploratory endpoint is the change in phosphatidyl ethanol or pest, which is a more objective blood based biomarker of alcohol consumption that represents alcohol intake over the most recent four to eight weeks. We look forward to sharing the top line data next quarter. In addition, the RESTORE trial in Alcohol Liver Disease (ALD) evaluating pemvedutide's effect on liver related nits markers of alcohol consumption and body weight is continuing to enroll and we now expect to complete enrollment in the third quarter of this year. In summary, with a heavy focus on the execution of the Performa Phase 3 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 one to one glucagon GLP1 dual agonist pemvedutide in serious liver diseases and with that I will turn the call to Linda. Linda Richardson (Chief Commercial Officer) Thanks Christoph and good morning everyone. The MASH market is evolving as approved drugs and a number of others in late stage development represent a range of modalities that aim to address various segments of the broader MASH patient population. This reinforces our belief that as the market continues to evolve, distinct patient segments with unique needs will begin to emerge. Satisfying those needs will be a key driver of success. As Christoph mentioned, our per forma Phase three trial design has factored in key learnings from our Phase two datasets and we believe this positions Pemvi well for future competitiveness in the market. The potential target product profile for pembedutide and MASH includes strong early metabolic benefits, significant improvements in inflammation and fibrosis and quality weight loss that also helps preserve lean muscle mass combined with a patient friendly simple titration that leads to a low rate of discontinuation due to gastrointestinal (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 disease. During our last two earnings calls, I shared key data points from market research studies we commissioned engaging healthcare professionals in both the US 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 Penvi were efficacious, showing early evidence of match resolution and NIT based antifibrotic effects while being well tolerated. In fact, there were fewer adverse events (AE) related discontinuations in the two Pemvi arms than in the placebo group. To potentially further enhance efficacy and optimize tolerability, our per former trial design includes a simple titration schedule that begins with an active starting dose of 1.2 milligrams and escalates to either a 1.8 or 2.4 milligram dose after only one or two titration steps of four weeks. In a real world setting, this patient friendly, simple and quick titration could readily translate to patients remaining on treatment longer, allowing for a greater likelihood of achieving therapeutic benefit, especially in a chronic condition like mesh. Now let's compare this combination of simple titration and favorable tolerability to other therapies on the market or being evaluated for use in mesh. GLP-1 based therapies in particular have been associated with gastrointestinal (GI) side effects that lead to discontinuations in both clinical trial and real world settings. One competitor's phase two 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 gastrointestinal (GI) related side effects. And still, approximately one in four patients discontinued therapy due to gastrointestinal (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 Pembi. We saw steady weight loss with our 1.8mg dose in our Phase II match trial with no evidence of plateauing over 48 weeks. This pattern also occurred in our obesity trial where PEMFI demonstrated less of an impact on lean muscle mass than has been reported in other GLP-1 trials, rapid drops in weight loss have been associated with a greater negative impact on lean muscle mass. Current projected average age at diagnosis for MASH patients in the US 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 match population should not be underestimated. We naturally begin to lose lean muscle mass as we age, with an acceleration of loss around age 60. By age 70, many people have lost 25 to 30% of the muscle mass they possessed in their prime. Over time, loss of lean muscle mass and muscle weakness can lead to metabolic dysfunction, reduced mobility, difficulty, performing activities of daily living and falls and fractures. Clearly, therapies that help reduce the impact of lean muscle loss in patients with MASH are needed for this at risk population and we will be evaluating this in our Phase 3 MASH program. We continue to believe very strongly in the potential of Penvede 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 three Match 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. Greg Weaver (Chief Financial Officer) 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 sales of $225 million million with participation from top tier biotech investors and as of March 31st we reported total cash of 332 million and on a pro forma basis our cash position as of April 30th is 535 million. This very strong cash position now provides us with the operating cash Runway through The pro forma phase 3 MASH 52 week data readout expected in 2029. Now moving to our financial results for the quarter R&D expense in Q1 2026 was $16.2 million as compared to 15.8 million for the same period prior year. The increase in R&D spend was driven primarily by the ongoing AUD and ALD trials as well as the startup cost for the Performa Phase III trial and MASH, partially offset by a decrease in expenses related to the completion of the Mpact Phase 2 trial and Mash, which was ongoing in 2025. The Q1 2026 spend includes $9.5 million of 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 26 also included $1.2 million in total noncash.comGeneral and Administrative (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 and A primarily driven by an increase in severance costs and professional fees. The first quarter 26General and Administrative (G&A) included $2.1 million in total noncash.com, the net loss for the first quarter 26 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 to perform a Phase three MASH trial in the second half of the year and top line data readout from the Phase 2 AUD trial next quarter. With the stronger balance sheet providing us with the cash Runway through Phase three data, we're now really focused on execution and looking forward to continuing to advance pempedutide. This concludes our prepared remarks and I'll now turn the call back to the operator for the Q and A session. OPERATOR Operator As a reminder, if you'd like to ask a question at this time, please press Star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again, our first question comes from Ellie Merle with Barclays. Ellie Merle (Equity Analyst at Barclays) Hey guys, congrats on all the progress and thanks for taking the question. 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? Jerry Durso (President and Chief Executive Officer) Thanks Ellie hi, thanks for the question. Christoph, can you take that one? Christoph Arvid Engels Sure. Yes, so the different presentations we're going to bring at easl. Sorry, regarding 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 read. We're going to have as well some look at our weight loss and potential lipid data cardiovascular risk in this population and obviously very importantly, we'll have our 48 week data that we'll be sharing in this oral presentation, that's been where the abstract was selected as best of 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. Ellie Merle (Equity Analyst at Barclays) Great, thanks. Jerry Durso (President and Chief Executive Officer) Thanks Ellie. OPERATOR Our next question comes from Roger Song with Jeffries. Roger Song (Equity Analyst at Jeffries) Great congrats for the quarter and then all the progress and thank you for taking the question since you're finalizing the phase three mesh trial starting second half and just curious, any internal analysis has been updated to the design potential for fertility or the sample size adjustment? So that's a question for MASH and then for aud. Can you just elaborate on what will be the go no go decision criteria before you can commit more investment into the pivotal stage? Thank you. Jerry Durso (President and Chief Executive Officer) Okay, maybe you started on the mash, I'll take the aud. Christoph Arvid 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 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. And then I'll let Jerry answer the AUD. Jerry Durso (President and Chief Executive Officer) Yes, thanks Roger. You know, we're definitely encouraged by all the interest emerging in the AUD indication overall and definitely look forward to the readout and 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 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 that scenario to really explore non dilutive options in terms of thinking about funding moving that program ahead. So again, next important step for us is to get the phase 2 data readout and that will give us some additional insight on again an indication where we think PEMBI can play a unique role potentially not only the impact on drinking, but also on the direct liver benefit which is such an important part of that disease as it progresses. Roger Song (Equity Analyst at Jeffries) Got it. Thank you. OPERATOR Our next question comes from Annabelle Cimimi with Stifel. Annabelle Cimimi Hi, thanks for taking my question. Just to follow on the AUD questions. So thank you for laying out the differentiation that you see versus semaglutide. What I'm wondering here is, given that they have recently shown some pretty meaningful data in AUD with the addition of glucagon, are there any measurements that you're looking at for AUD that could show the benefit of the direct liver targeting that you'll have with Penvedutide 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 endpoints, you have heavy drinking days, clearly, and you also have some abstinence. Is it clear what the final endpoint should be for phase three from a regulatory perspective? I'm just curious on that. Thank you. Jerry Durso (President and Chief Executive Officer) Okay, so maybe Christoph will 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. Christoph Arvid Engels Right. So no, thank you. So first, we're 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 3 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 a population that is fairly healthy otherwise, and for which penvedutide, if we continue to show what we've seen in our impact phase two match data, should be again, having a clear advantage with that population. So that's important. Regarding the endpoints for phase three, right now the FDA has proposed two endpoints. The zero heavy drinking days, heavy drinking days, or a change in two steps to levels in the wheel drinking ranking there between those. So we'll explore these two, we'll see where our data will lead us and we'll have those discussions with the FDA when we reach the end of Phase II meeting. Annabelle Cimimi Great, thank you. OPERATOR Our next question comes from Michael defiore with Evercore isi. Michael Defiore (Equity Analyst at Evercore ISI) Hi guys. Thanks so much for taking my question and congrats on the progress. Two questions for me. At your December impact call, you said that there was no obvious path to reevaluate the 24 week biopsy data in an AIM match like way because Liver Explorer is a different quantitative tool. That said, the easel poster now says quantitative digital pathologies 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 Path AI, does that change anything in how you plan to incorporate Aim Mash Assist into the Phase 3 biopsy read process? Thank you. Jerry Durso (President and Chief Executive Officer) Yeah, maybe I'll start with the second question first and then Christoph can clarify. There are a lot of different AI tools so it is a little important to track exactly which one is being used where first. I think on the question of the acquisition by Roche diagnostics of Path AI. As you would imagine, the teams are working extremely closely between Altimmune and Path on the phase three incorporation of the AIM MASH assist tool. And you know, that conversation has continued fully since the announcement and we don't anticipate any change to the process that's already been mapped and all the planning around how execution is going to work on being the first program that we'll be able to incorporate the AIM MASH Assist tool to the pathologists in the phase three. Maybe just some clarity then Christoff on the Q Fibrosis data versus the AIM MASH Christoph Arvid Engels assistance again, I mean sharing my enthusiasm. We are going to be the first registration study using that a match assist. So we are looking and working with the Passai team really closely. So no change there. We're just moving forward directly with the Q Fibrosis. So it's a little different approach that is assisting. So the AIM MASH cannot, because you need to do that in prompting the pathologist to the reading, et cetera. Going back would 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, Q Fibrosis, 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, itself. And those data are important. We believe that our drug Pemvidutide is decreasing MASH or leading to mesh 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 fibrosis and 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 effects early, even at 24 weeks. So putting those together, it's very exciting to see what we're going to get at Diesel. Michael Defiore (Equity Analyst at Evercore ISI) Thank you. Thank you. OPERATOR Our next question comes from Kripa Devarakonda with Truist Securities. Kripa Devarakonda (Equity Analyst at Truist Securities) Hey guys, thank you so much for taking my questions and congrats on getting best of EASL. So a couple of questions on the phase three trial design beyond the 52 week biopsy endpoint. I was wondering if you can provide a few more details. You're moving from the no titration phase two to starting with 1.2 milligrams and titrating. So can you just remind us of the rationale for the strategy and then with the inclusion of, you have both the 1.8 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. Christoph Arvid Engels All right. No, thank you for the question. The first thing is I want to remind you about the 48 week data that shows that basically our 1.2 and 1.8 milligram dose were efficacious dose. Our 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 patient with a very single step titration that will help them just improve in tolerability. We've seen our gift occurring within the first four weeks in general. So we believe that that first step will really help because of that placebo like tolerability. So that's why we designed it that way. And then with regard to the other, each of the other part of the questions what we have done is We've established those two armies. Our first key dose based on our phase two data is the 1.8 milligram dose. We believe it's a very efficacious dose. Our data support this. And on top of this, the tolerability and what we've seen at 48 weeks confirm this. So that's our anchored dose, if you wish. We've seen added weight loss in the obesity program with the 2.4 and based on this we believe that there's a potential for added efficacy. That's why we included 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 milligram arms, because clearly this is more of an exploratory approach if you wish, where we expect added benefits for, for these patients. Christoph Arvid Engels So that's how we've, we believe it's an upside on the efficacy part that we could see. And we're going to be looking at these endpoints at the end of the 52 week. Kripa Devarakonda (Equity Analyst at Truist Securities) Okay, great. Thank you so much. Christoph Arvid Engels Thanks, Greg. OPERATOR Our next question comes from William Wood with B. Riley Securities. William Wood (Equity Analyst at B. Riley Securities) Hi, thanks for taking our questions. Christoph Arvid Engels So, sort of A two from us. Just curious how you're seeing the long term treatment of patients with MASH on pembidutide. Has there been any sort of evaluation of dose reductions or what happens when patients dose reduce or even taking less frequent dose? And is that expected to be looked at in some of your upcoming trials? Maybe possibly even after your phase three reads out and then also just a quick add on or follow up to your easel data that you're expecting. It looks like in the abstract of your CV presentation that we'll be getting some visceral adipose tissue data or just vat. Could you just sort of confirm that we'll be getting the VAT data in that poster just given with what we've seen on the importance on sort of the CV benefits. Thanks. Right, so on the dose reduction first, I mean this is something that we've explored in our phase two. We've seen very few patients reducing the dose, no discontinuation and obviously we'll be looking at this in our phase three. We have put in place even for all the way to the 2.4 where these patients can reduce the dose. However, we are incentivizing 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 dose tested and allowing if there were any gastrointestinal (GI) tolerability. We believe even with the current titration scheme that we propose, that we're going to be even able to eliminate most of those and limit really to just a few patients those aspects. So that's the upside on the lipids and the cardiovascular risk. We'll be looking at the lipids profile to your questions. We have shown some lipids benefits through our previous studies and patients look at this. But we don't have like VAT assessments in the poster itself. Thank you. William Wood (Equity Analyst at B. Riley Securities) Thanks, William. OPERATOR Our next question comes from Arabella Ng with HC Wainwright. Arabella Ng (Equity Analyst at HC Wainwright) Hi, thank you so much for taking the question. I was just wondering, will Performa use a pre filter in your auto-injector and then if it is an auto-injector, have you secured a partner for that? And then just generally, are there any gating items you need to complete before you initiate the trial? Thank you so much. Jerry Durso (President and Chief Executive Officer) So maybe I start on the last part first and then we flip it to Christoph, as we said in the prepared remarks. And we'll stress we're in the full startup phase on the trial. So it's about really establishing the the global infrastructure, ensuring the vendors are online and ready, initiation of the trial sites, ensuring that the clinical supply chain is ready to support the initiation. So all of that activity is ongoing and the start of the trial with initiation in the second half is what we're moving towards. Christophe, maybe you take the other parts. Christoph Arvid Engels So for the phase three 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 in the phase two. So we're going to continue using that approach and have the auto-injector ready for launch. Jerry Durso (President and Chief Executive Officer) Thanks, Arbel. OPERATOR Our next question comes from Corinne Johnson with Goldman Sachs. Anupam (for Corinne Johnson) Hi, this is Anupam. Christoph Arvid Engels 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 three trial? Yes. So there's two. I mean obviously there's the regulatory path that requires the biopsy and that's the way regulatory agencies are Looking at this, the digital pathology, you have different aspects. You have like the AIM MASH assist, which is a tool that assists the pathologists in reading and prompt the pathologist to the features on the biopsy slides, which is in itself should be able to decrease the variability, increase consensus between pathologists as they're all prompted to the same features. And that's one approach. The other approach is some of the things we've done in our phase two study that we'll be continuing to look into. This lever explorer that was highly significant at 24 week, demonstrate the impact on fibrosis directly in a continuous manner. And the other one approach, which is this 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 pathologist to read the. 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 assessments and confirming the biopsy read from the pathology through the AIM MASH assist. But clearly in our Phase 3, the primary endpoint will be done on the biopsy using this a match assist tool for the reading. So we'll have a whole bunch of evidence that we will cross reference at the end of the study at week 52 for the accelerated approval. Anupam (for Corinne Johnson) Okay, thank you. OPERATOR Our next question comes from John Wallabin with Cities Citizens. John Wallabin (Equity Analyst at Cities Citizens) Hey, guys, thanks for taking the question and the updates today. Jerry Durso (President and Chief Executive Officer) Two for me. You know, mass trials are large and take a long time to run, but incredent trials go pretty fast. Wondering if you think about the pace of enrollment potentially being faster than we would expect in a mass trial because of the potential obesity benefit. And then big picture wise, you guys talk a little bit about differentiation. We're seeing more and more triple agonists get announced. You have more data now, but do you think down the road dual agonists get leapfrogged by the triples that are all 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 PEMBI will help? We've seen in the other trials and as you referenced clearly, John, the speed of the increment trials that typically go quickly. So we're understanding, we're building a robust study here, but we're targeting for good, efficient, effective enrollment and the profile and the weight loss is one of the components that we think will help with that. Christoph Arvid Engels Yeah, no, nothing else to add. I mean maybe the design of the study is also attractive because we have a couple of cohorts so more chances for our patients and the PIs to include their patients. So all in all you're absolutely correct. I mean the rate of enrollment is much higher for obesity when there's the weight loss. In addition, we have these features in the design of the study that help. Jerry Durso (President and Chief Executive Officer) John, on your second question, we are developing in and when we talk about differentiation we always have in mind the other combinations including the triples. Maybe Linda, you touch on how we see the ability of PENVI to be differentiated not just kind of with the products available today, but also with the coming therapies that might be available in the future. Linda Richardson (Chief Commercial Officer) Yes, certainly I think that we have an opportunity with to focus on our attributes of being both direct acting on the liver with the Glucagon and with our ratio of one to one glp, one to that and the package of benefits that we're seeing delivered there are very competitive even vis a vis the very metabolic forward as we've seen at this point. Metabolic forward, triple GS, the direct acting components haven't been as defined as ours in the one to one ratio. And I think looking at a tolerability profile and efficacy on multiple points, our ability with our safety profile frankly to be used in combination with other agents if they need to, we're delivering the full package and our titration, unlike some of these others as we've talked to, is very simple and not complex. So you see we have that tolerability and we have that effect on metabolic and even the opportunity to have additional weight loss. So we're seeing ourselves as a pretty fulsome, well rounded package that can hold our own and that we see early effects, sustained effects with weight loss, maybe some more efficacy with the 2.4 even on anti fibrotic and weight measures. So right now until we're really seeing things that aren't based on weight loss studies 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 different differentiator. You're not dumping a ton of weight loss right away and leading to more muscle mass being lost. So obviously always keeping an eye forward but confident in our ability to continue to display the differentiating benefits in our phase 3 trial and associated trials to make sure we have a very solid place in The MASH landscape in the future. Jerry Durso (President and Chief Executive Officer) Thanks, John. OPERATOR Our last question comes from Andy Shea with William Blair. Andy Shea (Equity Analyst at William Blair) Thanks for taking a question. Just a question on ADA data presentation. The other TLP1 glucagon assets Sermaglutide will have both the obesity data set and also the MASL data set. So I'm curious about how you would interpret that data when the full results come out. And secondarily, I think you emphasize a lot during the call about the probability profile. Just looking at. Andy, you're cutting up. Can you repeat your initial question? Sorry, let me just use my phone. Way better. Jerry Durso (President and Chief Executive Officer) Sorry about that. So it has to do with the GLP1 glucagon competitive assets are going to be preserved, presented at ADA. So I'm curious about how you would interpret there both the obesity data set and also the NASSHLD data set without biopsy. So that's first question number one. Question number two, you mentioned about the tolerability a lot during the call. Looking back in the phase two trials that you've conducted, momentum and impact, I'm curious if you have any persistence or adherence data. So for example, percentage of patients persistent throughout the trial or towards the end, that could really paint a picture of patients staying on therapy for penv. Thanks. Yeah, maybe we'll start with that one because I think it's an important one which we've talked about a bunch of. We do see in the 48 week data when we talk about the strong tolerability profile profile, that disadherence to treatment and the fact that such a large percent of the patients on pembi at both doses frankly stayed on therapy even more than placebo group. And when we talk about tolerability profile, 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 cervedutide and what we're seeing there maybe. And Christophe, you want to pick that up? Christoph Arvid Engels Yeah. No, again, so first, I mean in the impact and Momentum, etcetera, we see a clear dose response in favor of of the higher doses of penvuditide 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. So we have anecdotal evidence from some of our PIs telling us that are running different studies also other GLP-1 or even those three polys, et cetera. And they are telling us that Pemvidutide is a very different, 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 Sermaglutide aspect. So we've seen weight loss, they've seen weight loss similar to ours. It's been comparable. The big challenge in my mind is back to that tolerability. They had one, they needed a very long titration to get up to their efficacious dose. They even have set up some aspects where if they down titrate, you need a whole kind of new scheme to restart the patients, which is absolutely not our case. You've seen in the phase two you can jump the patient straight into their 1.18 milligram dose without any titration. So we are in two very different scenarios here. And the discontinuation rate is almost one in four patients that is not staying on the drug. So I believe there's a couple of aspects that we have here. Silver detail, look more like GLP-1 with a little bit of glucagon. That's the A21 ratio. We've heard people saying just a little splash of glucagon on top of GLP-1. And we believe that this ratio one to one is really important. And again, I cannot reemphasize in 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, but that also we've seen it already in our study. We'll continue to look into it in the Phase 3 pharma trial. OPERATOR That concludes today's question and answer session. I'd like to turn the call back to Jerry Dorso for closing remarks. Jerry Durso (President and Chief Executive Officer) Thanks operator. So we've made significant progress as we evolve into a late stage company. Ultimune 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. Thanks a lot for joining today. And everybody have a great day. Take care. Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company's SEC filings and official press releases. Corporate participants' and analysts' statements reflect their views as of the date of this call and are subject to change without notice.