Altimmune, Inc. (NASDAQ:ALT) Q3 2022 Earnings Conference Call November 10, 2022 8:30 AM ET
Richard Eisenstadt – CFO
Vipin Garg – President & CEO
Scot Roberts – Chief Scientific Officer
Scott Harris – Chief Medical Officer
Conference Call Participants
Seamus Fernandez – Guggenheim
Yasmeen Rahimi – Piper Sandler
Liisa Bayko – Evercore ISI
Mayank Mamtani – B. Riley
Jon Wolleben – JMP Securities
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. [Operator Instructions] As a reminder, this call is being recorded.
I would now like to introduce your host for today’s conference, Rich 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 [Technical Difficulty] 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 would also direct you to read the forward-looking statement 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 10, 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’re 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 1b NAFLD trial highlighted a 68.5% relative liver fat reduction at 12 weeks in the 1.8 milligram 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 topline data readout on a trial extension that offer 12 weeks of additional treatment to subjects who completed the original 12 week Phase 1b 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 2 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 1b 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 2 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 established its potential role in combination therapy for the treatment of this important disease. We are about — 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 1b NAFLD trial and additional data that was presented by Dr. Stephen Harrison, as a late breaker abstract at the annual meeting of the American Association for the Study of Liver Diseases in Washington, D.C. on November the 7. As Vipin noted, a 68.5% relative liver fat reduction was achieved in the 1.8 milligram 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 in biopsy endpoints when late stage clinical trials are conducted. Dr. Harrison presented new data that greater than 83% of subjects who received pemvidutide and who participated in corrected T1 or cT1 imaging sub-study achieved an 80 millisecond 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 millisecond 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 multicenter trial of subjects with NAFLD in mid-December, an extension to the original 12 week Phase 1b NAFLD trial. 66 or approximately 70% of subjects from the original 12-week Phase 1b NAFLD trial rolled over in this — 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 milligrams, 1.8 milligrams, 2.4 milligrams of pemvidutide or placebo.
As we initiated the study well after enrollment and 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 readouts. 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 rate 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 2 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 milligrams (ph), 1.8 milligrams, 2.4 milligrams 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 kilograms and 36 kilograms per meter squared respectively and median fat content of approximately 5% as measured in approximately 100 subjects participating in the 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 1b NAFLD trial where approximately 80% of subjects were of Hispanic ethnicity and the median fat content was approximately 22%. In addition, unlike the Phase 1b NAFLD trial, the Phase 2 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. Lou Aronne from Cornell — Weill Cornell Medical School, a leading authority in obesity and obesity clinical trials 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 enrolled, 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 and 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’ve also completed an enrollment in our Phase 1 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 incurred 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 readouts. We are also making continued progress in the enrollment of our Phase 2 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 the virologic effects of HepTcell are also being — are being evaluated in 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 Rich Eisenstadt to give an update on our third quarter financial results. Rich?
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 the discontinuation of development activities for 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 for 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 30, 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, where 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. [Operator Instructions] 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. So, really just wanted to ask, if you guys could help us understand what the characteristics were of the patients — of the 70 patients that were in — that are going to be in the extension 24 weeks portion of the study. So do you have the 12 week data in that context?
And 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? And if there were any meaningful differences at any of the dose levels in particular? Just want to get a better understanding of the base characteristics of that patient population as we head into the full 24 week data for the NAFLD patient population?
And then the second question, just as we kind of advance forward, we saw no real change and in fact some increases in HbA1c in the first 12-week data set in the NAFLD patient populations. 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.
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. But I don’t have specifics for you at this time. And our position has been that there has been no change in the hemoglobin A1c.
I think there was a great deal of variation due to small numbers. And all in all, when we looked at individual plots, we haven’t seen any change in hemoglobin A1c. So 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 overtime as insulin sensitivity improved concomitant with improved weight loss. And that’s why we expect to see a future time points. But 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 8 weeks to 12 weeks, over that time period when the weight loss hadn’t fully occurred that we wouldn’t see it.
Q – Seamus Fernandez
Great. And then maybe just a quick follow-up question. In terms of your expectation if the baseline 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 quite, I guess, substantially different metabolic characteristics of these patients with over 20% liver fat and 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 of 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 4 times the amount of liver fat. And whether or not they’re diabetics, they’re metabolic, where like diabetics, you don’t expect them to lose weight. And then it’s fairly clear that there is 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.
So we look at that NAFLD study and this extension is being what it was suited for which was to look at reduction of liver fat. And although, we are 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 gauge what that weight loss has to be to predict what we’re going to see in MOMENTUM, we think that study stands alone.
Thank you, guys. I’ll drop back in queue.
Thank you. And one moment for our next question. And 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 detail and updates. 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? And then, given the some of the patients who may have not chosen to continue to the extension, were there any reasons behind that? So that’s sort of part one and part two.
And then, the next question I had for you is, I’m very excited for the Phase 1b diabetes study that you’re going to read out in 1Q ’23. Help us understand what you hope to gain from this 48-patient study? Do you think it’s going to give us really a definitive answer in terms of pemvidutide glycemic effect? So I’d love to hear your color on both — on those three questions, and thank you, again for taking our comments and questions.
Yeah. Yasmeen, thanks for the questions. So 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.
And regardless of their success, many people simply said, I don’t have the ability. Remember, they’re getting — 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. So — and also the study started late so some people just didn’t have access to the study. So by and large, it was due to non-safety reasons or non-efficacy reasons that people chose not to continue.
Regarding the Phase 1 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 and that’s been our base case. We need to demonstrate that going forward and accrue more patients to show that the serum glucose in hemoglobin A1c do not change.
Now additional studies will likely be conducted in the future, looking at longer durations to treatment to see the hemoglobin A1c drops. But that’s beyond the initial 12 weeks that’s planned in that Phase 1 study or the objective of the trial.
Yes. And just to remind everybody that the 24 week, sorry, 48-week MOMENTUM study is in non-diabetic study. So that’s why it’s important to have that separate study, so we can look at specifically in subjects with diabetes. And that’s really the reason for that study.
Great. And then, team, just one quick clarification. I appreciate the baseline demographic details that you gave us for the MOMENTUM, the 100 kilogram, 36 kilograms 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, we tried to bring it out of my — I tried 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 months 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 going to read out in the first quarter of next year, the demographics may differ. We suspect it would differ slightly. But we are announcing the demographics of the population. We’re going to 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.
But it’s fair to say that we have a very stark difference here between the NAFLD population and the obesity study population. And that’s really the point that we’ve been making that we had significantly larger Hispanic population. 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 from — 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. And 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, sorry, the weight reduction or what’s the right expectation to set?
Liisa, that linear expectations for traditional weight loss study. And we expect the weight loss and MOMENTUM to be linear. This population is very different. There’s no prior information about how this study population will react or 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 going to increase. We’re not making any projections about the linearity because we think the study is so different from MOMENTUM trial, it bears no relevance to predicting the results of MOMENTUM.
Okay. And then for the MOMENTUM and obesity study, what should we expect 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 of percentage points or —
Yeah. So 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. And then for the diabetes study, the 12 week safety study, will this — 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 components?
Well, once again, like the NAFLD trial that we just talked about, the diabetes study is not being conducted as a weight loss trial, kind of being to conduct it as a diabetes safety trial. So we’re not 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 from me for now. Thank you.
Thank you. And 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. So maybe just a clarifying question for your comments about the MOMENTUM data expectation. So when you say class leaders, just to clarify, you mean glucagon directed therapies or just incretin broadly because as you know, for the latter even for six months, the weight loss bar may be getting elevated to even high-teens with some of the emerging data. So 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, the first wave of incretin had about 15%. Now we are approaching 20%. So really it’s that, 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 going to be important, but not the only component of overall value proposition, 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 cardiometabolic health that we are trying to improve here. So that’s what we mean is that we’re going to have to be there in that ballpark of the leading drugs in terms of weight loss. But then when you look at all of the other characteristics, we think there will be multiple drugs that would find a place. It’s a very heterogenous 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. And we took note of that, and we congratulate them on the excellent results and shows the 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 and achieve that. We don’t want to stress with that drug that it’s a new mechanism of action and approach that hasn’t been sufficiently explored. 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.
And therefore, they are going to be coming up with less than a full approach to cardiovascular outcomes reductions because of the absence of that effect and relying mainly on weight loss. So we think that, that’s still a problem with those drugs. And 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. But with the new mechanization of action, the long term safety is not known.
And 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 had deleterious effects on bone health, particularly in women, particularly with women with obesity who put more stress in their bones. So I think that we congratulate them in 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. And then just a couple of quick clarifying questions on the NAFLD and the diabetes studies. So is it fair to assume that most of the crossover patients in the 68 patients would be primarily weight loss responders, which means you may not have many in placebo? And I’m just curious what that may mean for kinetics of liver fat and liver enzyme? Should we focus on placebo-adjusted numbers for that 24 week readout?
Yeah. Mayank, I wish I could answer the question. But because we’re blinded, I just don’t have that data, right. And in terms of the kinetics, once again, let me emphasize that this study was conducted to look at reductions in liver fat. And I want to highlight the fact that the reductions in liver fat were excellent, were just excellent. And it was accompanied by many markers of good outcomes like the reduction of ALT and the reduction of cT1 times in MR scanning, right.
So 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 part of the United States, which is what we should do for 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.
So we’re very happy with that, but we’re trying to emphasize because of the great differences in the populations, in 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 on the study that 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 going to see in dedicated obesity trials with patients, dedicated obesity patients with one quarter the amount of liver fat and one quarter the amount of Hispanics.
Yeah. I would just add that in terms of liver fat reduction, further improvement in that as you — as you know that we’ve already gotten such a significant liver fat reduction in ALT improvement that going from 12 week to 24 week, you might improve some, but we’ve already reached such a — liver fat reduction occurs relatively quickly anyway. So just to be sure, we have already achieved significant liver fat reduction in just first 12 weeks.
Thank you. And one for Rich quickly, does the cash runway guidance include any considerations of you starting a Phase 2 NASH biopsy study possibly next year? Can you maybe just clarify that? And thanks again for taking our questions.
Yeah. So the expectation is we’ll be spending money to get ready for Phase 3 and/or obesity and/or for NASH. So we clearly don’t have the cash to complete a full Phase 3 campaign for obesity. So 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 2 ready for NASH and Phase 3 ready for obesity. The time lines will be different, so we are already working on putting together those plans in place. For NASH, we should be ready for Phase 2 by the second quarter of next year. So we can execute that trial if we decide to do so. And for obesity, we’ll not to wait for the 48 week data, and we’ll be ready for that, execution of that Phase 3 in the first half of 2024.
Yeah. Just to be specific, Mayank, 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. And 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 for me. You previously commented that the blinded weight loss for MOMENTUM was tracking in line with the first Phase 1 study. So I was wondering if you could update us on how that’s looking over time? And then 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. So regarding your first question, Jonathan, we took a single snapshot of the data at one time point that was comparable to the time points in the NAFLD trial. But 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 readout it 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. And that continues to be our position, that we’ll see maintenance of glucose control in these patients.
That’s helpful. Thank you.
Thank you. And one moment for our next question. And 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 [indiscernible] and I’m on for Patrick today. So my first question is going to be regarding the potential for pemvidutide in NASH, and can you discuss how it compares to others in the field? And 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 every — to any drug. The best liver fat reduction has been seen up till now with efruxifermin, we think that our data is at least comparable to that and better in some ways. So there’s a strong literature that reduction in liver fat translates to success on NASH resolution and fibrosis improvement endpoints in late phase trials.
So we’ve seen previously with the magical data. It was seen when the MGM program was active and was seen very strongly with the accurate data, and 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, and 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 corrected T1 or 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. But 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.
And they’ve also drawn inference from reductions of cT1 as improving cardiovascular outcomes. So I think that our positioning in NASH is really excellent. And 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. 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 at a time.
And what gets these people in NASH into trouble is they are being overweight, and 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. So, holistically, from the point of view of liver fat reduction, 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 developments.
Perfect. Thank you. I appreciate that. The next one I had is — 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? And then can you discuss what the dropout rate has been or is expected to be in the MOMENTUM program?
Great. So I can quote you the discontinuation rates in our first in human trial for adverse events, which were zero percent and in the NAFLD trial, it was zero percent at 1.2 milligrams, about 4% at 1.8 milligrams and about 4% of 2.4 milligrams, about what — 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 in that trial until the trial is completed.
But typically, in obesity trials, we’ve seen very, very high dropout rates. But 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, that will be the dropout rate in the MOMENTUM by the time the 48 weeks is concluded, but those are the range — that’s the range that’s been seen in other trials that have preceded us.
Great. Thank you. And then 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 approach is whether they’re algo-based or RNA-based that knock down the surface antigen and begin to release the immune suppression that’s 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 hepatocytes. So I think there’s probably a number of ways to look at that. There’s some schedule issues that have to be looked at. But conceptually, I think that’s probably the most straightforward approach.
Perfect. Thank you. I appreciate it.
Thank you. And 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.
That concludes today’s presentation. Thank you for participating. You may now disconnect.
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