Altimmune Q1 2024 Earnings Call Transcript

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May 9, 2024

There are 10 speakers on the call.

Operator

Good day, ladies and gentlemen, and welcome to Altimmune Inc. First Quarter 20 24 Financial Results Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. As a reminder, this call is being recorded.

Operator

I would now like to introduce your host for today's conference, Rich Eisenstadt, Chief Financial Officer of Altimmune. Rich, you may begin.

Speaker 1

Thank you, Gigi, and good morning, everyone. Thank you for participating in Altimmune's Q1 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 Scott Roberts, our Chief Scientific Officer and Scott Harris, our Chief Medical Officer. Following the prepared remarks from Vipin, Scott Harris and myself, we will hold a question and answer session. A press release with our Q1 2024 financial results was issued this morning and can be found on the Investor Relations section of the company's website.

Speaker 1

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. Aldamine 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.

Speaker 2

I will

Speaker 1

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 OptiMein's website. With that, I will now turn the call over to Doctor. Vipin Garg, Chief Executive Officer of Optimmune.

Speaker 1

Vipin?

Speaker 3

Thanks, Rich. Good morning, everyone, and once again, thank you for joining us for our Q1 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-one glucagon dual receptor agonist to contribute to the treatment of these 2 important diseases as we continue working towards our next milestones in each of these programs. Looking first at obesity.

Speaker 3

The body composition data from the Phase 2 MOMENTUM trial we reported at the end of March demonstrated that 74.5 percent of weight loss came from body fat and only 25 point 5% of weight loss came from lean mass in patients taking pemidutide. 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 trials could position pambidutide 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 Q3 of 2024. We look forward to this meeting which will help guide the design and conduct of our Phase registrational program for pemidutide in obesity.

Speaker 3

Turning to MASH, we are continuing to enroll patients in the IMPACT study, a Phase 2b biopsy driven trial evaluating 2 dosage of pamidutide against placebo in approximately 190 subjects. Top line results expected in the Q1 of 2025. Bemidutide is poised to be the 1st inpretin based therapeutic candidate to read out on a biopsy based endpoint in NASH after just 24 weeks of treatment, a reflection of our confidence in the ability of ambideotide to treat the liver inflammation and fibrosis that characterizes MASH. We believe that these data, a positive, could give pamidutide a meaningful advantage over other infretin based candidates, candidates being studied in NASH and further strengthen our competitive position as we enter late stage development. As you are all aware, our long term goal remains to partner pamidutide, 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.

Speaker 3

And who recognizes the significant potential of our candidate in obesity and MASH as well as other potential indications. In parallel with these ongoing partnering efforts and the continued advancement of pamidutide for MASH, we are taking additional steps to further leverage the pipeline in the drug potential of pamidutide. We are not yet in a position to share specific details around additional indications or development plans beyond the 2 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, Doctor.

Speaker 3

Scott Harris to discuss our plans. Scott?

Speaker 4

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 suggested 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 pemidutide 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.

Speaker 4

We plan to present the full data set 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 IIb 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 but 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 pathophysiology of NASH, but its comorbidities. We also believe that the weight loss alongside the treatment of the liver condition will be an important consideration for patients and physicians.

Speaker 4

We look forward to the top line data readout from this trial, which we continue to expect in the Q1 of 2025. Looking more broadly at the pemvadutide story and the value proposition, Altimmune has long recognized an 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 pemvadutide. If successful, these efforts can not only provide patients with the choice in how pemvidutide is taken, budoka also could support future life cycle management should pemvadutide ultimately be approved. We will be presenting an important medical conferences later this year, and we will be highlighting, among other things, the robust and potentially beneficial effects that pemvadutide has on serum lipids, including triglycerides, total cholesterol and LDL cholesterol.

Speaker 4

Recall that we recently reported on a preclinical study demonstrating the pempidutide 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 pemvadutide. With that, I will now turn the call over to our Chief Financial Officer, Rich Eisenstadt, to review our financial results for the Q1. Rich?

Speaker 1

Thank you, Scott, and good morning again, everyone. For today's call, I will be providing a brief update on Altimmune's Q1 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 Q1 of 2024 with approximately $182,100,000 of cash, cash equivalents and short term investments compared to $198,000,000 at the end of 2023. We project that our existing cash funds us into the first half of twenty twenty six, which fully funds our IMPACT trial in MASH.

Speaker 1

Turning to the income statement, revenue was negligible in the Q1 of 20242023. Any revenue reported during such periods was for indirect rate adjustments on a government contract that we are closing out. Research and development expenses were $21,500,000 in the Q1 of 2024 compared to $17,200,000 in the same period in 2023. Approximately $14,500,000 of this total for the Q1 of 2024 were direct expenses for the conduct of our clinical programs, including $13,500,000 in direct costs related to development activities for pempatutide and $1,000,000 in direct costs related to wind down and closing of HepTcell as announced on March 27, 2024. R and D expenses in the Q1 of 2023 included $8,900,000 in direct expenses associated with the development of pemvadutide and $2,100,000 in direct expenses related to hep T cell development activities.

Speaker 1

General and administrative expenses were $5,300,000 in the Q1 of 2024 versus $4,500,000 in the Q1 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 Q1 2024 was $3,800,000 all of which are recurring expenses. Net loss for the 3 months ended March 31, 2024 was $24,400,000 or $0.34 net loss per share compared to net loss of $20,100,000 or $0.40 net loss per share for the Q1 of 2023. The increase in net loss in the quarter is primarily attributable to the $4,200,000 higher research and development expenses as we ramp up the IMPACT Phase 2b trial in MASH.

Speaker 1

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

Speaker 3

Vipin? Thank you, Rich. We remain excited for what the future holds. With 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 pembitutide. Operator, that concludes our formal remarks and we would like to open the line to take questions.

Operator

Thank Our first question comes from the line of Roger Song from Jefferies.

Speaker 2

Great. Thanks for the update and taking all the questions. A couple from us. The first one is related to your upcoming end of Phase 2 meeting with the FDA for your obesity program. Given pembittatide has a very traffic effect in 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?

Speaker 2

And then I have a follow-up question related to your new development. Thank you.

Speaker 3

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

Speaker 4

Yes, Roger. Well, 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. And I think you've hit the nail on the head with what the objective of the meeting will be.

Speaker 4

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, 3 or 4 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 pemvadutide, 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.

Speaker 4

We 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 making 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, if followed out over a longer period of time, that ratio should drop even further and put pemidutide 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.

Speaker 2

Got it. Thank you. Thank you, Scott. Maybe quickly on your potential new development on 2 ends. 1 is the new indication for pembrozetide.

Speaker 2

Just curious, I understand you're not disclosed yet, but just curious in that kind of a comorbidity with obesity NASH or something pretty orthogonal to the current obesity and the MASH population? And in terms of your oral pamilutatide development, just curious what will be the formulation and how do you think about the scalability for your oral peptide? Thank you.

Speaker 4

Well, thanks for the question, Roger. I'll answer the question about the emerging development program and I'll then turn it over to Scott 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.

Speaker 4

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 now I'm going to turn it over to Scott Roberts to answer the question about the oral formulation. Scott?

Speaker 5

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 matrices to obtain an oral formulation for pempidotide. 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.

Speaker 5

So it's a reiterative 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 scalability, if we have a successful formulation, will not be an issue, and we continue to make progress on all fronts.

Speaker 2

Great. Thank you. That's it if I missed.

Operator

Thank you. One moment for our next question. Our next question comes from the line of Yasmeen Rahimi from Piper Sandler.

Speaker 6

Hey, team. Good morning. This is Jim on for Yas. Thanks for taking the questions. First, could you comment in regards to finding the right partner?

Speaker 6

Is this continuing to grow the company's financial 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?

Speaker 3

Scott, you want to take the second question first?

Speaker 4

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?

Speaker 6

Yes, that's correct.

Speaker 4

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 be represented at EASL. We have 3 presentations at EASL. Those have been posted on the EASL website.

Speaker 4

Those will address specific aspects of the effects of pemvadutide in MASH and its metabolism, its effects of 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

Speaker 1

the year. And do you want to

Speaker 3

comment on what we expect to learn from other presentations?

Speaker 4

Well, there are will be some presentations on other compounds. For example, we anticipate that the servadutide data will be presented at EASL and there will also be some presentations on tirzepatide. As you know, they 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 didn't have glucagon.

Speaker 4

And servadutide does have glucagon and they've announced that they've reached they achieved a statistical significance in 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 glucagon. So we feel that any success that they build, we can beat in our readout that's coming up in the Q1 of next year.

Speaker 3

Yes. In terms of your question about the right kind of partner, we've always maintained that the compound that we are developing pamidutide has 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.

Speaker 3

So 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 would help us develop both of these indications in parallel.

Speaker 6

Thank you so much.

Operator

Thank you. One moment for our next question. Our next question comes from the line of Corinne Johnson from Goldman Sachs.

Speaker 1

Good morning. This is Omari 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 PENVADU to that?

Speaker 3

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.

Speaker 3

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, yes, I mean these indications really are an extension of obesity and MASH sort of the broader indication in obesity and MASH.

Speaker 3

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.

Operator

Thank you. One moment for our next question. Our next question comes from the line of Alana Laihi from Guggenheim.

Speaker 7

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. So with Synergy NASH, from my understanding, they it was said that they had hit statistically significant fibrosis benefit, how do you see that impacting, the prospects of TEN in ASH?

Speaker 4

Well, 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 a compound rich in 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.

Speaker 4

So eventually they would hit an endpoint given enough patients in 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 read it out in an earlier time point. So we would congratulate them if they achieve statistical significance, but we would also highlight the fact that we believe that we will do better.

Speaker 7

Great. Thank you for that clarification. And then just very quickly on the partnerships. 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 hits 1Q 'twenty five?

Speaker 3

Yes. 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.

Speaker 3

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.

Operator

One moment for our next question. Our next question comes from the line of Mayank Mamtani from B. Riley Securities.

Speaker 8

Good morning, team. Thanks for taking our questions and good to see the Phase 2 in a Phase 2 meeting being calendered. So maybe just on that quickly, are you able to share how your specific plans could vary relative to say step into mount program. I believe Amgen may also be having similar FDA correspondence around same time. So wonder if any guidance from an FDA standpoint on this next wave of weight loss drug could be relevant here?

Speaker 8

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.

Speaker 4

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, a safety database of 5,000 subjects and probably distributing those subjects across 3 to 4 trials.

Speaker 4

We're going into the meeting with that expectation. And more than likely, there'll be a trial without diabetics and with diabetics, but there's still room for creating trials with endpoints in populations that enhance the value proposition of pemvadutide and the role glucagon in the treatment of obesity and provide differentiation as the obesity market becomes more sub 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.

Speaker 4

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 on the lipid effects, looking at body composition changes over time, looking at different durations of treatment in order to maximize the amount of weight loss, 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 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% lien loss, in their label, they report a higher rate of fractures in women and the elderly.

Speaker 4

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 pemvadutide be ideally suited for treating the elderly, especially frailer 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 as we choose our target population and our endpoints.

Speaker 8

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

Speaker 4

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 they're 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 at baseline, we saw a 21% reduction of LDL, which is comparable to the effects of statins.

Speaker 4

So going into that trial, we could have really very excellent effects that exceed that seen with semaglutide. We also have reported out data on lipidomics in the past showing that not only does pemvadutide 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 and liver like ceramides 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 those 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.

Speaker 8

Got it. And then just on the NASH development and you have Fast Track there. There's another glucagon directed program, which has now Phase 3 based on NIT endpoints, weight loss and NI 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?

Speaker 8

Thanks again for taking the question.

Speaker 4

Yes. 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.

Speaker 4

Of course, there are there's 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. NASH is a silent disease. And what they see on a day to day basis is their body weight.

Speaker 4

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, as we've said, the readout in the Q1 of next year.

Speaker 8

Got it. Thank you.

Operator

Thank you. One moment for our next question. Our next question comes from the line of John Wooliban from Citizens JMP.

Speaker 9

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 and you see any read through to pempidotide and others in the class? And how you're thinking about the diabetic population as an opportunity for pemvadutide?

Speaker 4

Well, thanks, Jonathan. So 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-one and glucagon to drive down blood sugar or hemoglobin A1c, but it clearly maintains it safely while patients drive 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.

Speaker 4

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 a glucagon mechanism where the weight loss is preserved in diabetics, which would be extremely attractive because as you know, diabetics with the GLP-one 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 could operate very nicely in the diabetes space. Okay.

Speaker 9

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?

Speaker 4

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

Speaker 4

So we're going to pursue that dose as well as the 1.8, 2.4 milligram doses going into Phase 3. But literally a physician could prescribe a dose of pemvadutide that's approved, not have to titrate up to it. In some patients, we're 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 to see how the patients do and then increase to other doses like 1.82.4 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.

Speaker 4

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 pempidotide 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 event discontinuations at all. And at the 1.8 milligram dose, there was no nausea reported.

Speaker 4

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.

Speaker 9

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

Speaker 4

Thanks, Jonathan.

Operator

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.

Speaker 3

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.

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