Good day, ladies and gentlemen, and welcome to the Altimmune Inc. Third Quarter Financial Results Conference Call. At this time, all participants are in a listen only mode. Later, we will conduct a question and answer session and instructions will follow at that time. To ask a question during the session, you will need to press star one one on your telephone. As a reminder, this call is being recorded. I would now like to introduce your host for today's conference, Richard Eisenstadt, Chief Financial Officer of Altimmune. Rich, please go ahead. Thank you, Michelle, and good morning, everyone. Thank you for participating in Altimmune's Third Quarter 2022 Financial Results Conference Call. Members of the Altimmune team joining me on the call today are Vipin Garg, our Chief Executive Officer, Scot Roberts, our Chief Scientific Officer, and Scott Harris, our Chief Medical Officer. Following the prepared remarks, we will hold a question and answer session. A press release with our third quarter 2022 financial results was issued this morning and can be found on the Investor Relations section of the company's website. Before we begin, I would like to remind everyone that remarks 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, including those related to the ongoing conflict in Ukraine, COVID-19, and the impact on our business operations, clinical trials, and results of operations. For a discussion of some of the risks and factors that could affect the company's future results, please see the risk factors and other cautionary statements contained in the company's filings with the SEC. I'd also direct you to read the forward-looking statements disclaimer in our press release issued this morning and now available on our website. Any statements made on this conference call speak only as of today's date, Thursday, November 10th, 2022, 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 conference call is being recorded and will be available for audio replay on Altimmune's website. With that, I will now turn the call over to Dr. Vipin Garg, Chief Executive Officer of Altimmune. Thank you, Rich, and good morning everyone. We appreciate you joining us today for a discussion of our Third Quarter 2022 Financial Results and Business Update. We are excited about the progress we are making with pemvidutide, our GLP-1/glucagon dual receptor agonist that we continue to advance for two important clinical indications, obesity and NASH. The recent data from our phase I-B NAFLD trial highlighted a 68.5% relative liver fat reduction at 12 weeks in the 1.8 mg dose group, which translated into more than half of those subjects achieving a normal liver fat content of 5% or less. These promising effects on liver fat content were accompanied at week 12 by significant reduction in serum ALT levels and cT1 imaging relaxation times, both recognized biomarkers of fibroinflammatory activity. Subjects receiving pemvidutide also lost a significant amount of body weight, which differentiates pemvidutide from other drugs with comparable effects on liver fat and ALT reduction. This is important because excess body weight is believed to be a principal driver of NASH and its comorbidities, and weight loss represents an important therapeutic goal in the treatment of these patients. In mid-December, we plan to announce the top line data readout on a trial extension that offered 12 weeks of additional treatment to subjects who completed the original 12-week phase IB trial in subjects with NAFLD. The key readouts will be similar to the readouts in the original 12-week study. Scott Harris will join us shortly to discuss our expectations for that readout. Obesity remains our primary focus and we completed randomization and first dosing of all subjects in our 48-week phase II MOMENTUM obesity trial at the end of September. A 24-week interim analysis is planned for Q1 2023, when we expect that approximately 160 subjects will have completed 24 weeks of treatment. We believe the interim readout should demonstrate meaningful weight loss with favorable tolerability in the absence of dose titration, which could differentiate pemvidutide from other obesity products. Scott Harris will present more on MOMENTUM trial in a moment. Enrollment is also complete in our 12-week phase I-B multicenter safety trial in subjects with Type 2 diabetes, and we expect this trial to provide important information regarding the ability of pemvidutide to maintain glucose control in this population as measured by hemoglobin A1c and serum glucose levels. Finally, we are continuing to enroll our phase II multicenter trial of HepTcell in subjects with inactive chronic hepatitis B and expect to have a data readout in the second half of 2023. Recall that this study is designed to show evidence of antiviral effects against HBV and establish its potential role in combination therapy for the treatment of this important disease. We are excited about the progress of pemvidutide and HepTcell and the upcoming results of these ongoing trials. With that, I will now turn the call over to our Chief Medical Officer, Dr. Scott Harris, to discuss our data and clinical plans. Scott? Thank you, Vipin, and good morning, everyone. First, let me briefly review the results of our phase I-B NAFLD trial and additional data that was presented by Dr. Stephen Harrison at the Late Breaker Abstract at the annual meeting of the American Association for the Study of Liver Diseases in Washington, D.C., on November the 7th. As Vipin noted, a 68.5% relative liver fat reduction was achieved in the 1.8 mg dose group at 12 weeks of therapy, which translated into more than half of those subjects achieving a normal liver fat content of 5% or less. These promising effects on liver fat content were accompanied at week 12 by significant reductions in serum alanine aminotransferase, a marker of hepatic inflammation. Reductions of these parameters have predicted a high likelihood of success on biopsy endpoints when late-stage clinical trials are conducted. Harrison presented new data that greater than 83% of subjects who received pemvidutide who participated in a cT1 imaging sub-study achieved an 80-ms or more reduction in cT1 relaxation times at week 12 at each pemvidutide dose. cT1 is a measure of fibroinflammatory activity in the liver, and an elevated cT1 score has been correlated with hepatic and cardiovascular events in clinical studies. Specifically, an 80-ms reduction has been shown to correlate with a two-point improvement in NAFLD activity score on liver biopsies. We believe these findings add further to the likelihood of success on biopsy endpoints, as well as the likelihood of reduced hepatic and cardiovascular events when outcomes trials are conducted. Next, let me talk about our upcoming readout in our 24-week multi-center trial of subjects with NAFLD in mid-December, an extension to the original 12-week phase I-B NAFLD trial. 66 or approximately 70% of subjects from the original 12-week phase I-B NAFLD trial rolled over into this extension trial to receive an additional 12 weeks of pemvidutide or placebo for a total of 24 weeks of therapy. The subjects that rolled over have remained double-blinded with respect to their assigned treatment of either 1.2, 1.8, 2.4 mg of pemvidutide or placebo. As we initiated the study well after enrollment in the original 12-week NAFLD trial had commenced, we are pleased with the 70% rollover rate into this trial. The principal readout will continue to be the safety and tolerability of pemvidutide, with reduction in liver fat content as the primary efficacy readout. The readout in December will also include weight loss, measures of liver inflammation, including serum ALT, cT1 relaxation time, lipids, hemoglobin A1c, fasting glucose, blood pressure and heart weight, and adverse events, including adverse events leading to treatment discontinuation. We report consolidated and stratified data on the trial readouts for subjects with and without diabetes. Now let me talk about the phase II MOMENTUM trial of pemvidutide in obesity. The trial was designed to enroll approximately 320 non-diabetic subjects with obesity or overweight with at least one comorbidity. Subjects were randomized 1 to 1 to 1 to 1 to 1.2 mg, 1.8 mg, 2.4 mg of pemvidutide or placebo, administered weekly for 48 weeks in conjunction with diet and exercise. Baseline characteristics of the fully enrolled study population include median body weight and body mass index, BMI, of approximately 101 kg and 36 kg per meter squared, respectively, and median fat content of approximately 5%, as measured in approximately 100 subjects participating in a body composition sub-study. The study population is approximately 75% female and approximately 20% of the subjects are of Hispanic ethnicity. These demographics contrast sharply with the study population in the 12-week phase I-B NAFLD trial, where approximately 80% of subjects were of Hispanic ethnicity and the median fat content was approximately 22%. In addition, unlike the phase I-B NAFLD trial, the phase II MOMENTUM study employs endpoints and lifestyle interventions that are standard for multicenter obesity trials. The primary endpoint of the MOMENTUM trial is the relative percent change in body weight at 48 weeks compared to baseline, with additional readouts including metabolic and lipid profiles, cardiovascular measures, and glucose homeostasis. Dr. Louis Aronne from Weill Cornell Medicine is serving as the principal investigator. We plan to perform an interim analysis to assess changes in body weight after 24 weeks of treatment on approximately 160 study participants in the first quarter of 2023. It should be noted that as a result of variations in patient characteristics as the trial enrolls, the demographics of the study population could differ from those in the fully enrolled study population when the interim readout occurs. It is our expectation that a level of weight loss consistent with the class-leading obesity drugs may be achieved at the end of 48 weeks of therapy. We also believe that the tolerability profile of pemvidutide, the absence of dose titration, and reduction in serum hepatic lipids could translate into greater ease of administration, improved adherence to therapy, and greater potential for cardiovascular benefit. We believe these benefits should differentiate pemvidutide from other drugs in the obesity space. We have also completed an enrollment in our phase I multicenter trial evaluating glucose control in subjects with Type 2 diabetes over 12 weeks of treatment. Approximately 48 subjects are planned, with readout expected in the first quarter of 2023. Across the trials that I have described, we are rapidly building the safety profile of pemvidutide. With unblinded safety data included in over 200 subjects receiving one or more doses of pemvidutide in clinical trials by year-end 2022, and approximately 500 subjects by year-end 2023. We believe that a positive effect on surrogates of cardiovascular outcomes, including blood pressure, serum lipids, and hepatic fat content, will be demonstrated at final readout. We are also making continued progress in the enrollment of our phase II multicenter clinical trial of HepTcell in subjects with inactive chronic hepatitis B and expect to read out the results of this trial in the second half of 2023. Recall that the virologic effects of HepTcell are also being evaluated in a chronically infected patient population to enable the combination of HepTcell with novel direct-acting antivirals as part of combination therapy for hepatitis B. I'll now hand the call over to Richard Eisenstadt to give an update on our third quarter financial results. Richard? Thank you, Scott, and good morning again, everyone. For today's call, I'll be providing a brief update on Altimmune's third quarter 2022 financial results. More comprehensive information will be available in our Form 10-Q to be filed with the SEC later today. Altimmune ended the third quarter of 2022 with approximately $201.9 million of cash, cash equivalents and short-term investments, compared to $190.3 million at the end of 2021. We drew down approximately $31.8 million in net proceeds off of our ATM during the three months ended September 30, 2022. Turning to the income statement, revenue was minimal in the third quarter of 2022 compared to $200,000 in the same period in 2021. Our change in revenue for the quarter was primarily due to discontinuation of development activities for our T-COVID and NasoShield programs earlier in 2021. Research and development expenses were $20.3 million in the third quarter of 2022, compared to $29.2 million in the same period in 2021. Approximately $15.8 million of this total for the third quarter of 2022 were direct expenses for the conduct of our clinical programs, including $14 million in direct costs related to development activities for pemvidutide and $1.8 million in direct costs related to development activities for HepTcell. R&D expense in the third quarter of 2021 included approximately $15 million of expense to close out the AdCOVID campaign. General and administrative expenses were $4.5 million in the third quarter of 2022 as compared to $4.2 million in the same period in 2021. The increase year-over-year was primarily attributable to increased stock compensation expense. Net loss for the three months ended September 30th, 2022, was $23.5 million or $0.48 net loss per share, compared to $33.5 million or $0.81 net loss per share for the third quarter of 2021. Our existing cash not only funds us through all of our ongoing clinical trials, but we currently estimate that our cash is sufficient to allow us to operate into the second half of 2024. I will now turn the call back over to Vipin for his closing remarks. Vipin? Thank you, Rich. Operator, that concludes our formal remarks, and we would like to open the lines to take questions. Could you please instruct the audience on the Q&A procedure? Thank you. If you have a question at this time, please press star one one on your telephone. One moment while we compile the Q&A roster. Our first question comes from the line of Seamus Fernandez with Guggenheim. Your line is open. Please go ahead. Great. Thanks so much for the question. Really just wanted to ask if you guys could help us understand what the characteristics were of the patients of the 70 patients that are gonna be in the extension 24-week portion of the study. You know, do you have the 12-week data in that context? You know, can you provide us a little bit of information with regard to if there were any differences in the data for those 70 or so patients versus the overall study? If there were any meaningful differences at any of the dose levels in particular. Just wanna get a better understanding of the baseline characteristics of that patient population as we head into the full 24-week data for the NAFLD patient population. Then the second question, just as you know, as we kind of advance forward, you know, we saw no real change and in fact some increases in HbA1c in the first 12-week data set in the NAFLD patient population. Just trying to get a better sense of how you guys are thinking about the profile of the product if we don't see improvements in HbA1c as patients are treated over time. Thanks so much. Scott? Yeah. Hey, Seamus, thanks for the question. Just to clarify, there was 70% rollover, but actually the number of subjects was 66. I don't have that immediate data for you. I can tell you that from 10,000 feet, I think that the rollover study population is comparable to what entered the initial, original 12-week trial. I don't have specifics for you at this time. You know, our position has been that there's been no change in the hemoglobin A1c. I think there was a great deal of variation due to small numbers. All in all, when we've looked at individual plots, we haven't seen any change in hemoglobin A1c. It's our position that at 12 weeks there was no change. We'll have further information on that when we finish our 12-week committed diabetes study in the first quarter of this year. Our position has always been that we would not see a change in hemoglobin A1c at 12 weeks, and that we would see changes over time as insulin sensitivity improved, concomitant with improved weight loss, and that's what we expect to see at future time points. Because of the opposing effects of glucagon on GLP incretin activity, the base case had always been that with the hemoglobin A1c, which is retrospective to eight to 12 weeks, over that time period when the weight loss hadn't fully occurred, that we wouldn't see it. Great. Then maybe just a quick follow-up question. In terms of your expectation, if the baseline, you know, characteristics of the 66 patients ends up being comparable, can you just help us understand what you think is a good result in this patient population, from a weight loss perspective, particularly, given the, you know, quite, I guess substantially different metabolic characteristics of these patients, you know, with over 20% liver fat and the Hispanic patient population. Just wondering what you guys think is a particularly good result in that patient population from a weight loss perspective. Thanks. Well, I think you hit the nail on the head. This is a distinctly different population from that is the NAFLD population that's continuing the extension from the MOMENTUM trial and the obesity trial. It's a metabolically very ill population with over four times the amount of liver fat. Whether or not they're diabetics, they're metabolically like diabetics, and you don't expect them to lose weight. It's fairly clear that there's a very important impact of Hispanic ethnicity has been shown in various studies, and that population has also been reduced in prevalence by a factor of four. We look at that NAFLD study and its extension as being what it was suited for, which was to look at reduction of liver fat. Although we're seeing a reduction in liver weight, it's not a weight loss study and it's not our primary readout in weight loss. We suspect that we'll continue to see improvements of weight loss, but we have not really gauged what that weight loss has to be to predict what we're gonna see in MOMENTUM. We think that study stands alone. Thank you, guys. I'll drop back in the queue. Thank you, and one moment for our next question. Our next question comes from the line of Yasmeen Rahimi with Piper Sandler. Your line is open. Please go ahead. Good morning, team. Thank you so much for the details and updates. A few questions for you this morning. Maybe the first one to start off would be when you noted that on the 66 patients that we will get 24-week data on, can you help me understand how many of the patients will be on drug and how many will be on placebo? Given you know some of the patients who may have not chosen to continue to the extension, were there any reasons behind that? That's sort of part one and part two. The next question I had for you is I'm very excited for the phase I-B diabetes study that you're gonna read out in 1Q2023. Help us understand what you hope to gain from this 48-patient study. Do you think it's gonna give us really a definitive answer in terms of pemvidutide glycemic effect? I'd love to hear your color on both of those three questions. Thank you again for taking our common questions. Right. Yeah, Scott. Yeah, Yasmeen, thanks for the question. Let me take them one by one. We have not unblinded the 106 data, so I can't tell you which patients have continued at each dose. We have no information on that, so I can't give you a snapshot of the continuation rates at each dose, or how much of the placebo patients continued versus, or the reasons per group of the discontinuations. Generally, the discontinuation reasons were administrative. Not that the patients discontinued, but you have to realize that patients were recruited for a 12-week study. Regardless of their success, many people simply said, "I don't have the ability." Remember, they're coming into the clinic weekly for 12 weeks. They come in weekly for an additional 24 weeks. An additional 12 weeks up to 24 weeks would be an undue burden. The study started late, so some people just didn't have access to the study. By and large, it was due to non-safety reasons or non-efficacy reasons that people chose not to continue. Regarding the phase I study that we'll read out in the first quarter of the year, the primary objective of the study is safety. The aim is to show that there's no adverse effects of pemvidutide on blood sugar control. That's been our base case. We need to demonstrate that going forward and accrue more patients to show that the serum glucose and hemoglobin A1c do not change. Now, additional studies will likely be conducted in the future looking at longer durations to treatment to see if the hemoglobin A1c drops. That's beyond the initial 12 weeks that's planned in that phase I study or the objective of the trial. Yeah, just to remind everybody that the 48-week MOMENTUM study is a non-diabetic study. That's why it's important to have that separate study so we can look at specifically in subjects with diabetes. That's really the reason for that study. Great. Team, just one quick clarification. I appreciated the baseline demographic details that you gave us for the MOMENTUM, the 100 kg, 36 kg BMI and the distribution. Is that for the total population or is it for the 100 patients? If you could just clarify, that would be helpful, and I'll jump back into the queue. Yeah, that's a great question, Yasmeen. I try to bring it in my opening remarks, but let me repeat it. That's for the entire study population. We don't have specific information for you today on those first 160 or so patients that are part of the interim analysis. We're saying in a generic way that population demographics can shift over the course of the four to five months of enrollment of the study, and that it's possible. We're not saying that it's likely, but that it's possible that what we're gonna read out in the first quarter of next year, the demographics may differ. We suspect it would differ slightly, but, you know, we are announcing the demographics of the population. We're gonna make it clear that the first 160 or so subjects may not have exactly these characteristics when they're read out because they vary over the course of the trial. It's fair to say that we have very stark difference here between the NAFLD population and the obesity study population. That's really the point that we've been making that we had significantly larger Hispanic population. You know, as you can see in the numbers, a huge difference. Same thing with the liver fat content and of course, the conduct of the study itself. This is a more traditional obesity study, which is being conducted at obesity centers. The whole feeling about the study is different compared to a liver fat reduction study. Thank you so much, team, for the color. Very helpful. Thank you. One moment for our next question. Our next question comes from the line of Liisa Bayko with Evercore ISI. Your line is open. Please go ahead. Hi. Thanks for taking my question. First of all, for the NAFLD update, can you just give us your expectations? Are you expecting the next readout to be kind of like linear in nature in terms of the obesity, the weight reduction or what's the right expectation to set? Liisa, that linear expectation's for traditional weight loss study. We expect the weight loss in MOMENTUM to be linear. This population is very different. There's no prior information about how this study population will react or, you know, will lose weight. The combination of the high Hispanics, the very high Hispanics, and probably the highest liver fat content that's been studied to date in trials, we just don't know what the weight loss is. We know it's gonna increase. We're not making any projections about the linearity because we think the study is so different from the MOMENTUM trial, it bears no relevance to predicting the results of MOMENTUM. Okay. For the MOMENTUM obesity study, what should we expect, you know, the effects of diet and exercise, the lifestyle changes to be at 24 weeks? Like, what kind of an impact would you expect that to have? Is that like a couple percentage points, or? Yeah. I'm looking across other trials, like the STEP trials and the SURMOUNT trials, and typically the weight loss peaks at about 2% around week 12 and then maintains itself over the course of the trial or out to, say, 24 weeks. Okay. For the diabetes study, the 12-week safety study, should we think of this as kind of a weight loss study, or how should we be thinking about kind of what sort of read-through to take from this study in terms of the efficacy component? Well, once again, like the NAFLD trial that we just talked about, a diabetes study is not being conducted as a weight loss trial. It's being conducted as a diabetes safety trial. We're not, you know, really relying on that trial to give us a readout on diabetics. We think that a committed obesity trial in diabetics would provide that answer, but we're not conducting that trial right now. Okay. I think that's it for me for now. Thank you. Thank you. One moment for our next question. Our next question comes from the line of Mayank Mamtani with B. Riley. Your line is open. Please go ahead. Good morning, team. Thanks for taking our question and congrats on the progress with three ongoing trials. Maybe just a clarifying question for your comments about the MOMENTUM data expectation. When you say class leaders, just to clarify, you mean glucagon-directed therapies or just incretin broadly? 'Cause as you know, for the latter, even for six months, the weight loss bar maybe getting elevated to even high teens, you know, with some of the emerging data. I just want to clarify what sort of your landscape of molecules look like when you think about weight loss for MOMENTUM. Yeah, that's a good question, Mayank. Well, look, if you look at the progression of weight loss, you know, the first wave of incretin had about 15%. Now we are approaching 20%. Really it's that ballpark we're talking about. Ultimately, we believe that there's going to be multiple products approved in this space and weight loss is gonna be important, but not the only component of overall value proposition. You know, multiple drugs will be approved for marketing and then depending upon what is their overall profile, the safety tolerability, ease of administration, lipid profiles are going to be very important. Ultimately, it's all about cardio-metabolic health that we are trying to improve here. That's what we mean is that we're gonna have to be there in that ballpark of the leading drugs in terms of weight loss. When you look at all of the other characteristics, we think there'll be multiple drugs that would find a place. It's a very heterogeneous patient population and physicians, doctors are going to need multiple options to treat these subjects. Scott, did you want to jump in? Yeah, Mayank. I think there's been some recent information on a compound that came out from Amgen where initial data was presented in very impressive weight loss, and you might be referring to that as now being in the mix. You know, we took note of that, and we congratulate them on the excellent results and shows that drugs can really have weight losses that are starting to approach bariatric surgery. We are happy to be in that group of drugs so that we think can achieve that. We'd wanna stress with that drug that it's a new mechanism of action and approach that hasn't been sufficiently explored. You know, we know about the GLP-1/GIP antibody combination. We know about the GLP-1 and GIP specifically, that they do not have meaningful effects on serum lipids, and they don't have meaningful effects on hepatic lipids. Therefore, they're gonna be coming up with less than a full approach to cardiovascular outcomes reductions because of the absence of that effect and they're relying mainly on weight loss. We think that that's still a problem with those drugs. Finally, not only don't we know about long-term efficacy, you're seeing a snapshot of results at a limited time point in the 12-week range. With the new mechanism of action, the long-term safety is not known. In specific with regards to that compound, it's known that GIP prevents bone resorption in humans. There's human data on that, and now we're giving antibodies against GIP that have deleterious effects on bone health, particularly in women, particularly with women with obesity who put more stress on their bones. I think that we congratulate them on the results. We're happy to be in the mix for long-term weight loss, and we're glad to see the bar going up and up. There's a lot more that has to be known about that mechanism of action, particularly on the safety side. Thank you. That's very helpful, and I think we'll learn more in a month's time from both you and Amgen. Then just a couple of quick clarifying questions on the NAFLD and the diabetes study. Is it fair to assume that you know most of the crossover patients in the 68 patients would be primarily weight loss responders, which means you may not have many in placebo? I'm just curious what that may mean for you know kinetics of liver fat and liver enzymes. Should we focus on placebo-adjusted numbers for that 24-week readout? Yeah. You know, Mayank, I wish I could answer the question, but because we're blinded, I just don't have that data, right? In terms of the kinetics, you know, once again, let me emphasize that this study was conducted to look at reductions in liver fat, and I wanna highlight the fact that the reductions in liver fat were excellent. Were just excellent. It was accompanied by many markers of good outcomes, like the reduction of ALT and the reduction of cT1 in MRI scanning, right? That was the primary readout of the study, and we went out to recruit a population with very, very high liver fat, came out of mainly Hispanics of Mexican origin ethnicity in the southwest parts of the United States, which is what we should do for a NAFLD trial. This is not a weight loss trial. Yes, we can observe weight loss. We are happy with the weight loss that we saw in the first trial that was commensurate with semaglutide on a placebo-adjusted basis. We're very happy with that. We're trying to emphasize because of the great differences in the populations and the very nature of the way that the study was conducted, with there being no branding or no emphasis on weight loss, no communication on weight loss, really, to patients, even investigators in the study. The kinetics of weight loss in this population or the kinetics of weight loss in the population, they don't translate to the kinetics that we're gonna see in dedicated obesity trials with patients, dedicated obesity patients with one quarter of the amount of liver fat and one quarter of the amount of Hispanics. Yeah. Got it. I would just add that in terms of liver fat reduction, further improvement in that, as you know that we've already gotten such a significant liver fat reduction and ALT improvement that, you know, going from 12 to 24 weeks, you might improve some, but we've already reached, you know, liver fat reduction occurs relatively quickly anyway. Just to be sure, you know, we have already achieved significant liver fat reduction in just the first 12 weeks. Thank you. One for Rich quickly. Does the cash runway guidance include any considerations of starting a phase II NASH biopsy study, possibly next year? Could you maybe just clarify that? Thanks again for taking our question. The expectation is we'll be spending money to get ready for phase III and/or in obesity and/or for NASH. We clearly don't have the cash to, you know, complete a full phase III campaign for obesity. We haven't really necessarily designated which dollars are going which direction, but we can get started in either or both of those indications. Yeah. Our goal is to be both phase II ready for NASH and phase III ready for obesity. You know, the timelines will be different, so we are already working on putting together those plans in place. For NASH, we should be ready for phase II by the second quarter of next year, so we can execute that trial, if we decide to do so. For obesity, we'll have to wait for the 48-week data, and we'll be ready for that execution of that phase III in the first half of 2024. Yeah, just to be specific, Mike, we would not start the NASH trial or any NASH trial before we see the interim readout from obesity. Okay. Thanks for clarifying that. Thank you. One moment for our next question. Our next question comes from the line of Jon Wolleben with JMP Securities. Your line is open. Please go ahead. Hey, thanks for taking the questions. A couple from me. You previously commented that the blinded weight loss for MOMENTUM was tracking in line with the first phase I study. I was wondering if you could update us on how that's looking over time. Secondly, on the diabetes study, Scott, you mentioned the key here is HbA1c and serum glucose. Just wondering if there's any more specific bars on worsening levels that are acceptable, or is any change a clear negative here? Just hoping for a little more specifics there. Thanks. Yeah. Regarding your first question, Jon, we took a single snapshot of the data at one time point that was comparable to the time points in the NAFLD trial. I'm talking about the MOMENTUM snapshot and the 101. Excuse me, the first in human study that was done in Australia. We have not been following blinded weight loss curves over time, so I can't communicate that data to you. We don't have that data. Regarding the hemoglobin A1c and the glucose, in the diabetes study that we'll read out in the first quarter, yes, it's a safety study. Our base position has always been that there will not be any changes. We don't expect any worsening. You know, that continues to be our position, that we'll see maintenance of glucose control in these patients. That's helpful. Thank you. Thank you. One moment for our next question. Our next question comes from the line of Patrick Trucchio with H.C. Wainwright. Your line is open. Please go ahead. Hi. This is Matthew Loccisano, and I'm on for Patrick today. My first question is gonna be regarding the potential for pemvidutide in NASH, and can you discuss how it compares to others in the field? Where would you envision it situated in the emerging NASH treatment paradigm? Well, thank you, Matthew. Well, the data that we have, we think compares to any drug. The best liver fat reduction has been seen up till now with efruxifermin, and we think that our data is at least comparable to that and better in some ways. There's a strong literature that reduction in liver fat translates to success on NASH resolution and fibrosis improvement endpoints in late-phase trials. That was seen previously with the Madrigal data. It was seen when the NGM program was active, and it was seen very strongly with the Akero data. We would suspect that with the same, if not better, levels of liver fat reduction probably achieved in a shorter period of time, that we will see comparable effects in a late-phase NASH trial. We've received comments from KOLs like Stephen Harrison that this is the best data that he's seen yet at this phase of development. It's also accompanied now by the changes of the cT1 data, and that's very important because that maps fibroinflammatory activity the same way the ALT marks inflammatory activity. Non-invasive markers that have appeared to be very predictive of success in biopsies. Going, if you would allow me, outside of the exact, the field of NASH, cardiologists are now looking at cT1 data, inflammatory activity in the liver, to predict inflammatory activity in coronary and cerebrovascular plaques. They've also drawn inference from reductions of cT1 as improving cardiovascular outcomes. I think that our positioning in NASH is really excellent. Not only do we have comparable levels of liver fat data and at least as good reductions in fibroinflammatory activity in our current trials, but we have one thing that the other compounds in NASH with similar levels of fat reduction don't have, which is meaningful weight loss. You know, the weight loss with efruxifermin, and I believe it was at 24 weeks, was approximately 2.6%. We're seeing about double that in about one half the time. You know, what gets these people in NASH into trouble is their being overweight. The principal morbidities of NASH are not necessarily the liver effects, but the cardiovascular effects, especially in the early phases of the disease, and weight loss is very meaningful for these people. Holistically, from the point of view of liver fat reduction in inflammatory activity, fibroinflammatory activity, plus the meaningful reduction of weight, I think that we stand alone in the NASH spectrum of drugs and development. Perfect. Thank you. I appreciate that. The next one I had it's a follow-up question on the safety and tolerability profile of pemvidutide, particularly the discontinuation rates that you've seen so far, and then how does that compare to others in the field? Can you discuss what the dropout rate has been or is expected to be in the MOMENTUM program? Great. I can quote you the discontinuation rates in our first human trial for adverse events, which were 0%. In the NAFLD trial, it was 0% at 1.2 mg, about 4% at 1.8 mg, and about 4% at 2.4 mg. About half of what you would see in other trials. If you look at the MOMENTUM trial and of course we won't know the dropout rate on that trial until the trial is completed. Typically in obesity trials we've seen very, very high dropout rates. With improvements in the way the trials have conducted, we've seen dropout rates of about 20% in the more recent trials. I cannot tell you that will be the dropout rate in MOMENTUM by the time the 48 weeks is concluded. That's the range that's been seen in other trials that have preceded us. Great, thank you. I have one more. Following the AASLD, I'm wondering if a preference is emerging for Altimmune in terms of which antiviral mechanism you would prefer to combine with the HepTcell program. Hey, Matthew, this is Scot Roberts. You know, I think there's a number of options out there, but in general, I think that the approaches, whether they're oligo-based or RNA-based, that knock down the surface antigen and you know, begin to release the immune suppression that's a characteristic of chronic hepatitis B, those probably make the most sense. You can imagine a scenario where those types of agents are used first. Surface antigen is decreased, the T-cell responses are beginning to wake up and respond, and then we come in with HepTcell and help boost those responses against the antigens that are being expressed in the hepatocyte. You know, I think there's probably a number of ways to look at that. There's, you know, some scheduling issues that have to be looked at. Conceptually, I think that's probably the most straightforward approach. Perfect. Thank you, I appreciate it. Thank you. I'm showing no further questions at this time, and I'd like to turn the conference back over to Vipin Garg for any further remarks. Yes, thank you everyone for participating today. We appreciate this opportunity to share our results and outlook with you, and thank you for your continued interest. Have a nice day. This concludes today's presentation. Thank you for participating. You may now disconnect.