Altimmune Inc (ALT) 2024 Q1 法說會逐字稿

Good day, ladies and gentlemen, and welcome to Altimmune Inc., first-quarter 2024 financial results conference call. (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, you may begin.

Thank you, Gigi, and good morning, everyone. Thank you for participating in Altimmune's first quarter 2024 financial results and business update conference call. Members of Altimmune's team joining me on the call today are Vipin Garg, our Chief Executive Officer; Scott Harris, our Chief Scientific Officer -- or Scot Roberts, our Chief Scientific Officer; and Scott Harris, our Chief Medical Officer. Following the prepared remarks from Vipin, Scott Harris, and myself, we'll hold a question-and-answer session.

A press release with our first-quarter 2024 financial results was issued this morning and can be found on the Investor Relations section of the company's website. Before we begin, I'd 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. For a discussion of some of the risks and factors that could affect the company's future results and operations. Please see the risk factors and other cautionary statements contained in the company's filings with the SEC.

I will 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, May 9, 2024, 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. Vipin?

Thanks, Rich. Good morning, everyone. And once again, thank you for joining us for our first quarter corporate update. On our last call, I shared our excitement about our accomplishments in 2023 with respect to the advancement of pemvidutide in the obesity and MASH indications that we are currently pursuing. We remain optimistic about the potential of our differentiated GLP-1 glucagon dual receptor agonist to contribute to the treatment of these two important diseases as we continue to work towards our next milestones in each of these programs.

Looking first at obesity. The body composition data from the Phase 2 MOMENTUM trial we reported at the end of March, demonstrated that 74.5% of weight loss came from body fat and only 25.5% of weight loss came from lean mass in patients taking pemvidutide. This is comparable to effects associated with diet and exercise based on historical data. This degree of lean mass preservation, together with the significant overall weight loss, and robust reductions in liver fat and serum lipids observed in each of our prior clinical trials, could position pemvidutide as a best-in-class therapy for individuals with obesity and dyslipidemia or excess liver fat.

These impressive results will be part of a comprehensive package of clinical and preclinical data that we plan to present to the FDA at our end of Phase 2 meeting, which we expect will be held late in the third quarter of 2024. We look forward to this meeting with the -- which will help guide the design and conduct of our Phase 3 registrational program for pemvidutide in obesity.

Turning to MASH, we are continuing to enroll patients in the IMPACT study, a Phase 2b biopsy-driven trial evaluating two doses of pemvidutide against placebo in approximately 190 subjects. Top-line results expected in the first quarter of 2025.

Pemvidutide is posed -- poised to be the first incretin-based therapeutic candidate to readout on a biopsy-based endpoint in MASH after just 24 weeks of treatment. It's a reflection of our confidence in the ability of pemvidutide to treat the liver inflammation and fibrosis that characterizes MASH. We believe that these data, if positive, would give pemvidutide a meaningful advantage over other incretin-based candidates being studied in MASH and further to strengthen our competitive position as we enter late-stage development.

As you are all aware, our long-term goal remains to partner pemvidutide. And we are firmly committed to finding a partner with the ability to maximize the near and long-term value of the program for Altimmune and our shareholders, and who recognizes the significant potential of our candidates in obesity and MASH as well as other potential indications. In parallel with these ongoing partnering efforts and the continued advancement of pemvidutide for MASH, we are taking additional steps to further leverage the pipeline in a drug potential of pemvidutide.

We are not yet in a position to share specific details around additional indications or development plans beyond the two currently being studied, but we believe this is a valuable initiative. These efforts are underway, and I look forward to providing additional information as our plans take shape. With that, I'll now turn the call over to our Chief Medical Officer, Dr. Scott Harris to discuss our plans. Scott?

Thank you, Vipin. As we discussed in March, the MOMENTUM data generated to date are extremely encouraging. Not only did we achieve impressive overall weight loss at 48 weeks, but the trajectory of the weight loss suggests that the potential for even greater weight loss with continued treatment. Importantly, the body composition analysis showed a class-leading preservation of lean mass with nearly 75% of the weight loss coming from fat, comparable to what is seen following diet and exercise based on historical data.

Moreover, the preferential loss of visceral fat over subcutaneous fat that was observed in MOMENTUM may further differentiate pemvidutide as it is well-established that visceral fat, that is fat associated with organs like the liver, heart and kidney, is linked to a greater risk for cardiovascular disease than subcutaneous fat. We plan to present the full dataset from the body composition analysis, as well as other new data from MOMENTUM at key medical congresses later this year.

Looking at the MASH program, enrollment in the Phase 2b IMPACT study continues to progress well. Despite a recent FDA approval in this indication, we believe there remains a major unmet need for a drug that not only reduces MASH fibrosis that leads to clinically meaningful weight loss. We believe that weight loss is a critical component in the treatment of NASH as excess body fat, not only drives the path of physiology of MASH but its co-morbidities. We also believe that the weight loss alongside the treatment of the liver condition will be an important consideration for patients and physicians. We look forward to the top line data readout from this trial, which we continue to expect in the first quarter of 2025.

Looking more broadly at the pemvidutide story and the value proposition, Altimmune has long recognized in optionality and choice for patients will be important differentiators in the treatment of the metabolic diseases that we are pursuing. To that end, we are continuing to make progress towards our previously stated objective of developing an orally administered formulation of pemvidutide. If successful, these efforts cannot only provide patients with a choice in how pemvidutide is taken, but it also supports future lifecycle management should pemvidutide ultimately be approved. We will be presenting in important medical conferences later this year.

And we will be highlighting, among other things, the robust and potentially beneficial effects that pemvidutide has on serum lipids, including triglycerides, total cholesterol, and LDL cholesterol. Recall that we recently reported on a preclinical study demonstrating that pemvidutide treatment improved cholesterol elimination through an important natural process called reverse cholesterol transport. Those data and the clinical data that we were reporting -- we will be reporting over the next several months describe changes in lipid metabolism that may ultimately be associated with decreased cardiovascular risk. We believe the type and magnitude of these lipid effects are best explained by the action of glucagon receptor agonism in pemvidutide.

With that, I will now turn the call over to our Chief Financial Officer, Rich Eisenstadt, to review our financial results for the first quarter. Rich?

Thank you, Scott, and good morning again, everyone. For today's call, I'll be providing a brief update on Altimmune's first quarter 2024 financial and operating results. More comprehensive information will be available in our Form 10-Q to be filed with the SEC later today.

Altimmune ended the first quarter of 2024 with approximately $182.1 million of cash, cash equivalents, and short-term investments compared to $198 million at the end of 2023. We project that our existing cash funds us into the first half of 2026, which fully funds our IMPACT trial in MASH.

Turning to the income statement, revenue was negligible in the first quarter of 2024 and 2023. Any revenue reported during such periods for indirect rate adjustments on a government contract that we are closing out.

Research and development expenses were $21.5 million in the first quarter of 2024 compared to $17.2 million in the same period in 2023. Approximately $14.5 million of this total for the first quarter of 2024 were direct expenses for the conduct of our clinical programs, including $13.5 million in direct costs related to development activities for pemvidutide and $1 million in direct costs related to wind down and closing of HepTcell as announced on March 27, 2024. R&D expenses in the first quarter of 2023 included $8.9 million in direct expenses associated with the development of pemvidutide, and $2.1 million in direct expenses related to HepTcell development activities.

General and administrative expenses were $5.3 million in the first quarter of 2024 versus $4.5 million in the first quarter of 2023. The $800,000 increase is due primarily to an increase in stock compensation and other labor-related expenses.

Our quarterly non-cash operating expenses for the first quarter 2024 was $3.8 million, all of which are recurring expenses.

Net loss for the three months ended March 31, 2024, was $24.4 million or $0.34 net loss per share compared to net loss of $20.1 million or $0.40 net loss per share for the first quarter of 2023. The increase in net loss in the quarter is primarily attributable to the $4.2 million higher research and development expenses as we ramp up the impact Phase 2b trial on MASH.

I will now turn it back over to Vipin for his closing remarks. Vipin?

Thank you, Rich. We remain excited for what the future holds. It's several important milestones in the coming months. We believe that Altimmune is well positioned for long-term value creation as we continue advancing the development of pemvidutide.

Operator, that concludes our formal remarks, and we would like to open the line to take questions.

Thank you. (Operator Instructions) Roger Song, Jefferies.

Great.

Thanks for the update and taking our question. A couple from us. The first one is related to your upcoming and the Phase 2 meeting with the FDA for your obesity program. Given pemvidutide has played top pick, it's back to many different ways to differentiate, just curious how -- what kind of endpoints you will plan to incorporate into your program to really capitalize those differentiation in the potential label? And then I have a follow-up question related to your new development.

Thank you.

Thanks, Roger. Scott, do you want to take that?

Yeah, Roger, thanks for the question. We're greatly looking forward to the end of Phase 2 meeting. We think it's going to be greatly value enhancing to really set forward our program and to really maximize the value proposition.

I think you've hit the nail on the head with what the objective of the meeting will be. I mean, just as an oversight, we expect the program to have about 5,000 patients. We're making -- we're taking a good look as to whether we want to conduct, say three or four pivotal trials across those 5,000 patients. But I think the key thing will be to choose the best population that will most meaningfully bring out the effects of pemvidutide, the effects on the lipids, the effects on the body composition, the effects on the liver fat. So that a lot of the discussion will center around choosing the population for the studies. I think some other important points here will be selecting the optimal treatment duration.

We've got great results at 48 weeks but is there a potential for getting even better results in weight loss and even better body composition at a longer time point, that decision, we're really looking forward to meeting with the FDA. As you know, we had 25% loss of lean mass, 75% loss of fat mass at 48 weeks. But that ratio of lean-to-fat goes down over time. So I follow it out over a longer period of time, that ratio should drop even further and put pemvidutide at the top of its class in terms of its preservation of lean mass. So the number of trials, the selection of the population to maximize the value proposition, particularly the lipids, liver fat, the body composition, and the duration of treatment, are all things that we aim to get agreement with the agency when we meet with them.

Got it. Thank you, Scott. Maybe quickly on your potential new development on 2M, one is the new indication for pemvidutide, just curious, I understand you did not disclose yet, but just curious in that kind of a co-morbidity with obesity, MASH or something pretty (inaudible) to the current obesity and MASH population. And in terms of your oral pemvidutide development, just curious what will be the formulation? And how do you think about the scalability for your oral peptide? Thank you.

Well, thanks for the question, Roger. I'll answer the question about the emerging development program, and I'll then turn it over to Scot Roberts to specifically answer the question about the oral formulation.

So as you know, companies are pursuing new indications surrounding obesity in order to maximize their value proposition.

With regards to Altimmune, we are specifically, as you pointed out, looking for indications that reflect the value proposition of glucagon, which is very differentiating. So the effects of glucagon on serum lipids, for example, the effects on body composition, and also diseases of the liver that are associated with fatty liver or even obesity. So we believe that the indications will reflect specifically what glucagon brings to the table. And we're very hopeful to make a decision about new programs in the near future. But I'm going to turn it over to Scot Roberts to answer the question about the oral formulation. Scot?

Hey, good morning, Roger. So as we've indicated in the past, we're pursuing a number of different approaches, different types of formulations, different metrices to obtain an oral formulation for pemvidutide. Those studies are ongoing. The work is incremental. You find a formulation that has some merit and is looking good, and it's optimized, and then retested. So it's a really good process, and we're in the middle of that with a number of different approaches. We are expecting and hoping to still nominate a candidate for development by the end of the year.

As far as the scalability question, one of the criteria that we set for successful oral formulation is a specific level of bioavailability to ensure that the amount of drug substance required for that would be appropriate and attainable and useful. So the scalability, if we have a successful formulation, will not be an issue, and we're continuing to make progress on all fronts.

Great. Thank you. That's it from my end.

Yasmeen Rahimi, Piper Sandler

Hi, team. Good morning. This is [Thomas] on for Yas. Thanks for taking the questions.

First, could you comment in regards to finding the right partner? Is this continuing MASH IMPACT results? And secondly, with upcoming EASL conference, what do you hope to gain from competitor presentations to shed light into your own program and increase the probability of success?

Scott, do you want to take the second question first?

Yes. So I think if I heard correctly, and I apologize if I did not. You're asking about the upcoming liver meetings in Europe, the EASL meetings, is that correct?

Yes, that's correct.

Right. Let me start by saying that we have a variety of presentations that are planned for meetings across the entire year. So we will [not be represented] at EASL. We have three presentations at EASL. Those have been posted on the EASL website. Those will address specific aspects of the effects of pemvidutide in MASH in its metabolism -- its effects on metabolism. And we think that, that will continue to be differentiating, but the impact on the science, the impact on the differentiation, the value proposition, the body composition data, the effects on lipids, the effects on other aspects of lipids that have not really gotten as much attention, these things will all come out at key scientific congresses over the course of the year.

And do you want to comment on what do we expect to learn from other presentations?

Well, there are -- will be some presentations on other compounds. For example, we anticipate that the survodutide data will be presented at EASL. And there will also be some presentations on tirzepatide. As you know, they've had top line readouts on their results, at least in press releases. We're looking forward to that. As you know, the tirzepatide data did not hit the fibrosis endpoint, which is something we would have expected by a mechanism that doesn't have glucagon. And survodutide does have glucagon, and they've announced that they've reached -- they've achieved statistical significance on the fibrosis endpoint, and we look forward to hearing that.

But we would emphasize that, that's due to the presence of glucagon in the molecule, and we have a much greater amount of glucagons. So we feel that any success that they built, we can beat in our readout that's coming up in the first quarter of next year.

In terms of your question about the right kind of partner, we've always maintained that the compound that we are developing, pemvidutide, had very compelling data, both in obesity as well as in MASH. And if you think about it, MASH and obesity really intersect each other, it's going to be hard to differentiate in these patient populations down the line because most people with MASH also need to lose weight. So we think we bring a perfect combination of these two things. Our focus has been -- in terms of the right partner, has been on partners that value both of these indications and our goal is to find a partner that will help us develop both of these indications in parallel.

Thank you so much.

Thank you. Corinne Johnson, from Goldman Sachs.

Good morning. This is Mario on for Corinne. So a couple of questions from us.

Could you provide an update on how the partnership discussions are progressing? And do you plan to bring in a partner for the new indication you want to pursue with pemvidutide?

Yes. I mean, in terms of -- thanks for the question. In terms of the partnership discussions that continues to be a topic of interest. What I can say is that our partnering efforts are ongoing. We have the numerous factors that come into play in sort of finalizing a partnership discussion. So stay tuned. Those efforts are ongoing, and we expect to have a partner before we go into Phase 3 development for obesity.

We -- as we mentioned earlier on the call, we are getting ready for the end of Phase 2 meeting. We think that's going to be very value-driving having that information, as well as additional data, in terms of the additional indications, yeah, I mean, these indications really are an extension of obesity and MASH, sort of the broader indication in obesity and MASH. And we're trying to figure out where does our compound has the maximum value creation opportunity, differentiation opportunity relative to other compounds that are mainly GLP-1 focused.

Thank you. Alana Lelo, Guggenheim.

Hi, there. Thanks for the question. I just wanted to circle back a little bit on the potential outcome of the synergy NASH study and back to the partnerships, again. With SYNERGY-NASH, from my understanding, it was said that they had a clinically meaningful benefit on fibrosis, but there was no direct commentary on whether that was statistically significant or not.

If it turns out that tirzepatide does lead to statistically significant fibrosis benefit, how do you see that impacting the prospects, (inaudible) NASH?

Thanks for the question, Alana. So as we've continued to state, these drugs do not have the same liver defining effect or effects on fibrosis improvement that the compound rich and glucagon has. So it is possible that they could have meaningful results potentially statistically significant. These drugs will eventually have a direct effects on fibrosis, if you have enough patients and you follow them out long enough. And we know that from bariatric surgery, where that's simply a reduction of caloric intake.

So eventually, they would hit an endpoint given enough patients and enough time. But I think you've seen from our original data that the speed and the robustness of the effects are tremendously enhanced in the presence of glucagon, such that we can get a better treatment effect. And actually, we did that in an earlier time point. So we would congratulate them if they achieved statistical significance. But we would also highlight the fact that we believe that we will do better.

Great. Thank you for that clarification. And then just very quickly on the partnership. With respect to timing, is it -- are you still confident that a partner can be secured this year? Or are you thinking that it might be more likely after the NASH data hit once year '25?

Yeah. Thanks for the question, Alana. Look, it is difficult to pinpoint the timeline for partnering. As I've said, our efforts are ongoing. We would love to have our goal remains to have a partner before the end of the year, before we start the obesity Phase 3 program. But let's see how things develop on that front as our discussions progress, we'll know better. But at this point, we are committed to having a partner on board before the start of Phase 3 in obesity.

Great. Thanks so much for taking my question.

Welcome.

Thank you. Mayank Mamtani, B. Riley Securities.

Good morning, team. Thanks for taking our questions, and good to see the Phase2 -- in the Phase 2 meeting being calendared. So maybe just on that quickly, are you able to share how your specific plans could vary relative to say, step in to mount program. I believe Amgen may also be having similar FDA correspondence around same time. So I wonder any guidance from an FDA standpoint on this next wave of weight-loss drugs could be relevant here? And also if you are able to comment on the outcome trial commitment, how big that could be, given, obviously, you have a big lipid benefit? And then I have a couple of follow-ups.

Well, thanks for the question, Mayank. I'm not sure I heard the entirety of the first question, so please persist if I don't answer it completely. So look, this meeting that we're going to have later this year is going to be extremely value enhancing for the company. And there are a lot of great things that we can get done at this meeting that really enhance our goals and objectives, specifically around glucagon, and what glucagon brings to the table in the treatment of obesity.

So we're expecting that there will be certain things in place that are expected, safety database of 5,000 subjects, and probably distributing those subjects across three to four trials. We're going into the meeting with that expectation. And more than likely, that will be a trial without diabetics and with diabetics.

But there's still room for creating trials with endpoints and populations that enhance the value proposition of pemvidutide in the role of glucagon in the treatment of obesity and provide differentiation as the obesity market becomes more segmented. So as we know, the obesity population right now is not well differentiated. Right now there's not great certainty about what those segments will look like. We know that it will become more segmented, the same way hypertension became differentiated over time.

So our goal is to ride that wave and to find ways that we can really stress differentiation based on glucagon mechanism. And as I pointed out before, that could include choosing the best population, for example, to enrich in the liver -- lipid effects, looking at body composition changes over time, looking at different durations of treatment in order to maximize the amount of weight loss, because since as you know, the weight loss was steeply continuing at 48 weeks in trial, and the improvement of body composition.

Now with respect to the body composition, we know that loss of lean mass is associated with loss of function, and also a higher rate of bone fractures, particularly in the elderly and also in women. So we saw in the semaglutide trial, they had a 40% loss of lean mass, which exceeds the natural weight loss -- the natural loss of lean mass from diet and exercise, which is about 25%, which is what we achieved. But with that 40% lean loss, in their label, they report a higher rate of fractures in women and the elderly. So now you can see the immediate implications on the market and the differentiation on the segments.

For example, because of its preservation of lean mass, could pemvidutide be ideally suited for treating the elderly, especially frail or individuals or women with osteoporosis risk, which is a huge segment of the population? Recognizing that women with lean bone mass are carrying around extra weight, which increases the risk of fractures. So all in all, these are discussions that we'll have with the FDA's, which is our target population and our endpoints.

Super helpful. I think you've covered a lot. If you could comment on the outcome trial, scope -- scale and scope, given you have a big lipid benefit.

Right. Obviously, that's going to be a great benefit to us. I think that's where we can really differentiate because as you're aware in the SELECT trial, there was a 20% reduction of MACE, major adverse cardiac events. Just in the basis of weight loss alone and their effects on serum lipids are minimal. At best, I believe there -- if I'm quoting the data correctly, the reduction of LDL cholesterol and total cholesterol only in the range of about 3% to 5%. Recognize that in our population of subjects with elevated serum lipids to baseline, we saw a 21% reduction of LDL, which is comparable to the effects of statins.

So going into that trial, we could have really very excellent, excellent effects that exceed that seen with semaglutide. We also have reported out data on lipidomics in the past, showing that not only this pemvidutide reduce the amount of LDL and total cholesterol, it also changes the very nature of the lipids that are circulating inflammatory lipids, that are known to damage the cardiovascular system in liver like ceramide and diacylglycerols.

So we're very optimistic about conducting that trial. Optimistically, that is a trial that we'd like to start within Phase 3 and get the results as soon as possible so that we have it around the time of market authorization, and that would be something that we hope to achieve in the discussion with the FDA.

Got it. And then just the NASH development. And you have fast track there. There's another glucagon-directed program which has now basically based on NIT endpoints, weight loss, and MRI-PDFF, no biopsy. I was just curious if you could also get some preliminary guidance on what your late-stage MASH development could look like. And maybe just remind us on the enrollment for IMPACT, are you on track to complete enrollment in 3Q? Thanks again for taking my question.

Yeah, thanks for the question, Mayank. The obesity meeting is going to be with the endocrine division, our NASH program is going to be with the liver division. So I don't really think there's going to be an immediate opportunity to get information about the NASH development. Of course, there are -- there is overlap and interchange of ideas. And clearly any information we get from obesity, we can take forward to enhance NASH development.

Regarding enrollment, it's going extremely well. We think this reflects the fact that patients with NASH are seeking treatments that have visible, clear effects on them that they can see. MASH is a silent disease. What they see on a day-to-day basis is their body weight. So given the opportunity to lose weight in the trial, they're coming into the trial at very handsome rates, and this robust rate of enrollment is going to support us. We've said the readout in the first quarter of next year.

Got it. Thank you.

Thank you. Jon Wolleben, Citizens JMP.

Hey, thanks for taking the question. We had some data last night from another GLP glucagon agonist. I was wondering if you guys saw, because we've heard some critiques that glucagon agonist may not be effective and even detrimental for diabetics. But this data set in Chinese patients showed superiority to dulaglutide. And I was wondering your thoughts on that data set. Do you see any read through to pemvidutide and others in the class? And how you're thinking about the diabetic population as an opportunity for pemvidutide ?

Well, thanks, Jonathan. So you know, just to emphasize, we've seen excellent control of blood glucose in our program. And this drug is not designed specifically based on its ratio of GLP-1 and glucagon to drive down blood sugar hemoglobin A1C, but it clearly maintains it safely while patients derive a whole variety of other benefits. So we continue to believe that the data that you've talked about as well as our own data supports the safety and effectiveness of the drug in all populations, including diabetics.

I would emphasize that we are seeing in our studies, weight loss in diabetics equivalent to the weight loss in non-diabetics. This is something that's of great interest to us as we go forward into Phase 3, because it is possible that there is something unique about the glucagon mechanism with a weight loss is preserved in diabetics, which would be extremely attractive because, as you know, diabetics with the GLP-1 based compounds like semaglutide and tirzepatide seem to take a [haircut] in the diabetic population. So we are extremely interested in pursuing that and believe that we can operate very nicely in the diabetes space.

Okay.

And then one more, if I may. Just how do you -- as you guys are planning for your Phase 3 program, can you talk about the trade-off between the shorter titration, which you guys have talked a lot about in the past versus improving the tolerability profile with a slower titration like we've seen from other programs? And how you think about the importance of both, and your thoughts going into the Phase 3?

Thanks. Great question, Jonathan. And something that we're giving a lot of thought to. The first thing I would say is that 1.2 dose of pemvidutide is extremely attractive. It has an adverse event profile, an adverse event discontinuation rate similar to placebo. And I want to remind everybody, it's given without dose titration.

So we're going to pursue that dose as well as the 1.8 milligram, 2.4 milligram doses going into Phase 3, but literally a physician could prescribe a dose of pemvidutide that's approved, not have to titrate up to it and some patients were achieving 20% weight loss on that. And the natural use of the drugs in clinical practice is that these drugs are started on the lowest dose. The doctors wait see how the patients do and then increase to other doses like 1.8 milligrams and 2.4 milligrams as they go forward.

So in practice, the scheme that you're talking about of titration is really only a construct of clinical trials. In practice, doctors naturally titrate by starting on a low dose waiting, observing, and then going to the next dose, and the next dose.

Now with regards to the construct in clinical trials, we're very happy with the tolerability profile of pemvidutide as we've currently developed. We know that the allowance of dose reduction, which happens all the time in clinical practice, but specifically allowed in all of the other obesity trials, will greatly enhance the tolerability profile of the compound.

We're seeing single digit adverse event discontinuation rates in our MASH, in our NAFLD trials, in our diabetes trials. We saw no adverse events discontinuations at all. And the 1.8 milligram dose, there was no nausea reported. So that aside from the obesity population, this drug is very well-tolerated. That being the case, there is the optionality to pursue longer dose titration in a Phase 3 program. It's something that we've considered, it's something on the table as we go forward into discussions with the FDA.

Very helpful color, Scott. Looking forward to seeing those details when you announce them.

Thanks, Jonathan

Thank you. At this time I am showing no further questions. I would now like to turn the conference back over to Vipin Garg for closing remarks.

Thank you. Thank you, everyone, for participating today. We appreciate this opportunity to share our results and outlook with you, and thank you for your continued support. Have a wonderful day.

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