Altimmune, Inc. (NASDAQ:ALT) reported its second-quarter financial results before Tuesday’s opening bell.
Below are the transcripts from the Q2 earnings call.
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OPERATOR
Good morning ladies and gentlemen and welcome to the Altimmune Second Quarter 2025 Financial Results Conference call. At this time, all participants are in listen-only mode. After the speaker’s presentation, there will be a question and answer session. To ask a question during the session you will need to press star 11 on your telephone. You will then hear an automated message that your hand is raised. As a reminder, this call is being recorded on our Let me introduce your host for today’s conference call, Lee Roth, President of Burns McClellan Investor Relations Advisor to Altimune. Lee, you may begin.
Lee Roth (President of Burns McClellan Investor Relations Advisor)
Thanks, Olivia. Good morning everyone. Once again, thank you for joining us for the Altimmune second quarter 2025 financial results and Business Update conference call. On today’s call you’ll hear from Dr. Vipin Garg, our Chief Executive Officer, Dr. Scott Harris, our Chief Medical Officer and Greg Weaver, our Chief Financial Officer, Dr. Scott Roberts, Our Chief Scientific Officer and Ray Jord, our Chief Business Officer will join us for the Q and a. Our second quarter 2025 financial results and corporate update press release was issued earlier this morning and it can be found on the Investor Relations section of the Altimmune website. Before we begin, I’d like to remind everyone that remarks made about future expectations, plans and prospects constitute forward looking statements for purposes of the 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 and these could cause our actual results to differ materially from those indicated. For a full review of the risk factors that could affect the Company’s future results and operations, we refer you to the Company’s filings with the sec. I also direct you to read the forward looking statement disclaimer in our press release issued this morning which is available on our website. Any statements made on this call speak only as of today’s date, August 12, 2025 and the Company does not undertake any obligation to update any forward looking statements to reflect events or circumstances that occur on or after today’s date. As a reminder, this call is being recorded and will be available for audio replay on the altimmune website. With that, it’s my pleasure to turn the call over to Dr. Vipin Garg, President and Chief Executive Officer of Altimune.
Dr. Vipin Garg (President and Chief Executive Officer)
Vipin thank you Lee Good morning everyone and thank you for joining us today for our second quarter financial results and corporate update. As many of you know, we presented the 24 week top line data from the impact trial at the end of June as we shared Pemvedutide achieved statistical significance in the primary endpoint of match resolution and across multiple objective measures of efficacy at 24 weeks of treatment. These included all noninvasive markers of inflammation and fibrosis, liver fat reduction and weight loss, along with best in class safety and tolerability without the need for dose titration. These data will serve as the foundation of the package that we take to the FDA for our end of Phase 2 meeting in the fourth quarter and will inform the design of our Phase 3 program. In addition to the advancement of our NASH program, our Phase two trials in AUD and ALD, Reclaim and Restore are now underway. Alcohol use Disorder and alcohol-associated liver diseases are two indications with significant unmet needs and few to no treatment options for which we believe pembidutide may be particularly well suited. As we announced yesterday, our board has appointed Jerry Durso as Chairman of the board, succeeding Dr. Mitch Sayer who has served in this role for the past seven years and will remain with us as a non Executive Director. This change reflects our planned advancement to Phase three development of pemvidutide in mash. Gerry has a wealth of commercial and corporate development experience including the building of a successful liver franchise as CEO of Intercept prior to its acquisition. We are excited to continue moving forward under Jerry’s leadership and look forward to Mitch’s ongoing contribution with 1.83.1 million in cash and cash equivalent. We have considerably strengthened our balance sheet as we work to continue to advance the development of Pembidutide and look forward to reaching additional milestones including the full 48 week impact data as the year progresses. With that, I’ll now turn the call over to Dr. Scott Harris, our Chief Medical Officer to provide a clinical development update.
Dr. Scott Harris (Chief Medical Officer)
Scott thank you Vipin. Those of you on the call with us are likely familiar with the impact top line data that we reported about six weeks ago. I’d like to expand upon a few of the key highlights of this positive and important data set. First, we achieved match resolution up to 59.1% of subjects, a highly statistically significant result after 24 weeks of treatment. On the other measure of fibrosis improvement, we did not reach statistical significance but clear evidence of anti fibrotic activity was observed that was supported by additional objective measures of fibrosis improvement. As Vipin noted, multiple measures of efficacy that were assessed at the 24 week time point achieved statistical significance. We demonstrated impressive results in all of the non invasive tests of liver fibrosis including enhanced liver fibrosis and vibration controlled transient elastography. In addition, the path URI based analysis of biopsies the showed a statistically significant improvement in liver fibrosis in a supplemental analysis. We recently completed our analysis of another important non invasive test of fibro inflammation corrected T1 imaging or CT1 where a class leading effect for pemvidutide was observed at the 24 week time point. CT1 is a reproducible MRI based liver imaging method that has been correlated with changes in liver inflammation and fibrosis in clinical studies. Decreases in CT1 relaxation time of 80 milliseconds or greater have been correlated with improvements in liver inflammation and fibrosis in clinical studies. At 24 weeks, mean decreases from baseline and CT1 relaxation time were 145.0 and 147.9 milliseconds in the 1.2 and 1.8 milligram pemvidutide treatment arms respectively, compared with a decrease of 27.5 milliseconds in placebo representing a P value of less than 0.001 for both doses. These new data add additional depth to the data demonstrating that strong anti inflammatory and antifibrotic activity of pemvedutide treatment. In addition to these impressive effects on the liver, pemvedutide was associated with a greater than 6% decrease in body weight at 24 weeks of treatment with a weight loss trajectory indicating that further weight loss was likely. Decreases in body weight are important in MASH patients as they succumb to the complications of obesity at greater rates than the complications of liver disease until cirrhosis actually develops. In the aggregate, the impact top line data compare very favorably to other NASH therapies including those that have read out at much later time points. Now moving to safety, Pemvidutide demonstrated potentially class leading results in that important area. Through 24 weeks Pemvidutide was remarkably well tolerated with only a single adverse event related discontinuation across the two pempidutide treatment arms versus two adverse event related discontinuations in the placebo group. It is worth noting that this excellent tolerability was achieved in the absence of dose titration which is unique for our GLP1. For GLP1 based agents, the ability to start patients in a dose that is both effective and tolerable will be highly attractive to prescribers and will be another key differentiator for our therapy. We’re continuing to analyze the 24 week data and look forward to providing updates as the results become available. The team is preparing for our fourth quarter end to phase two meeting with FDA that will further guide our phase three plans. We will also be reporting the full 48 week data in the fourth quarter. This data will include the non invasive tests that were reported at the 24 week readout. Weight Loss and Safety in addition to our NASH program, we’ve made progress in the development of pemvidutide in two additional indications, AUD and ALD, with the initiation of phase 2 trials in these indications in May and July. AUD and ALD are serious and highly prevalent conditions. Recurrent treatment approaches are inadequate and innovation has been limited. We claim our AUD trial is a 24 week trial evaluating weekly 2.4 milligram pempedutide versus placebo. The primary endpoint is the change in the number of heavy drinking days with key secondary endpoints including other measures of alcohol intake and weight loss including the World Health Organization risk drinking level which has recently been accepted by FDA as an additional basis of approval in this indication. Restore the Phase two trial and ALDI started enrolling in July. It is a 48 week trial evaluating the 2.4 milligram weekly dose of pemfidutide versus placebo with a primary endpoint of change in liver stiffness measurement at 24 weeks. Liver stiffness is a non invasive measure of liver inflammation and fibrosis that characterizes the prognosis and severity of ALD. Key secondary endpoints include an assessment of liver stiffness at 48 weeks as well as changes in ELF score, alcohol consumption and body weight at both 24 and 48 weeks. And with that I’ll turn it now over to Greg Weaver who will review our second quarter financial results.
Greg Weaver (Chief Financial Officer)
Greg thanks Scott. Beginning with the balance sheet, we finished the second quarter with total cash of 183.1 million. That’s an increase of approximately 40% over our cash position at the start of this year. We’ve raised 88 million in gross equity capital this year while adding the flexibility of $100 million Hercules debt facility, which we announced in the second quarter and drew down 15 million from that facility at signing. These strategic financial moves are part of our ongoing efforts to ensure that our balance sheet is able to support the continuing clinical development of pemvidutide. We are committed to staying focused on driving value as we work to position PEMVI to benefit NASH patients. Now to briefly comment on the Q2 financial results. First, R&D expenses which were 17.2 million for the three months ended June 30 as compared to 21 million in the same period of 2024 and this amount includes $11.2 million of direct costs related to pemvidutide development. Breaking that down further, including approximately $5.5 million for the impact phase 2b trial, $2.6 million for AUD and ALD startup phase 2 costs and $1 million for our pemvedutide oral formulation. General and Administrative (G&A) expenses were consistent period over period at 5.7 and 5.6 million for the quarters ended June 30, 25 and 24. Really nothing noteworthy to call out in our G&A net loss for the second quarter of 2025 was 22.1 million or 27 cents a share, compared to a net loss of 24.6 million or 35 cents a share in the second quarter of the the prior year. With that, I’ll turn the call back to Vipin for closing remarks.
Dr. Vipin Garg (President and Chief Executive Officer)
Thank you Greg. The second half of 2025 will be an exciting period for Altimmune as We report the 48 week impact data and prepare for our end of phase two meeting while continuing to enroll the phase two trials in AUD and ALD trials. This concludes our formal remarks and we would now like to open the line to take questions.
OPERATOR
Thank you ladies and gentlemen. If you’d like to ask a question at this time you will need to press Star 11 on your telephone and wait for your name to be announced. To withdraw your question simply press star 11 again. Please stand by. Will be compiled Q and A roster now first question coming from the lineup. Annabelle Simimi with Stifel. Your line is now open.
Stifel Anlayst
Hi, this is Jayed on for Annabelle. Thanks for taking our question. I have two the first one related to the MASH development plan. You’ve had some time to digest the data and we did see fibrosis improvement not reach statistical significance, but to what extent could you still leverage the other improvements and a PathAI analysis at week 24? How does the FDA view these new measures and could you potentially get it into the label by including those endpoints in a Phase three?
Dr. Scott Harris (Chief Medical Officer)
Hi Jed, this is Scott and thank you for the question. There’s more and more emphasis being placed on noninvasive tests and the overall feeling among experts in the area is that we will be moving to a non invasive test or NIT based improvement at some point in the future. I think the FDA is warm to that. We actually haven’t seen that happen at this point. I want to remind you that we achieved highly statistically significant effects on ELF and VCTE sometimes called FibroScan, which are considered the best non invasive tests for assessing fibrosis. And Also the Path AI should remind you that PathAI analyses have been accepted in Europe as the basis of approval and that FDA is now reviewing that proposal and we should have some news in that in the near future. So we think that based on these highly recognized and validated measures of fibrosis improvement, that we not only have excellent evidence that fibrosis improvement is occurring, we’re actually meeting what could be FDA and EMA expectations for approval in both of these areas. So as we’ve said before, there is a great deal of evidence that we have very potent anti fibrotic effects. We’re very confident about our ability to be able to hit these effects in phase three.
Dr. Vipin Garg (President and Chief Executive Officer)
Yeah, I just want to add that just to remind everybody that this readout was at 24 week, at 48 week or beyond, which is where really the phase three program will be designed for. We believe that we will hit the statistical significance in the fibrosis endpoint with longer trial and larger trial. That would reduce the placebo noise. That’s really the reason we didn’t hit the endpoint in this 24 week study. So we feel very good about going into a phase three program in spite whether the NITs are allowed or not. Even without that, we should hit the fibrosis endpoint in a longer phase three trial.
Stifel Analyst
Thank you. I had one more question. It’s related to the AUD and ALD trial. I could be wrong about this, but I do recall you guys mentioning that you would test different doses, like 1.2, 1.8, 2.4 with titrations. But it looks like you’re only testing the 2.4 milligrams in these trials. Is there a particular reason for that?
Dr. Scott Harris (Chief Medical Officer)
Yeah, Jayad, I mean, we think that for a phase two trial, it’s appropriate to only test one dose. We’re testing the most efficacious dose and then we’ll have that conversation with FDA and other regulatory agencies going forward. And there’s always the opportunity to expand that and to analyze different doses in a phase three program. But we think that we’re going in with what will be our most efficacious dose and then we can reexamine other doses as the program unfolds.
Stifel Analyst
Great, thank you.
OPERATOR
Thank you. Now, next question coming from the lineup. Ellie Murr, would you be as your line is now open.
Analyst
Hey, this is Jasmine on for Ellie. Thank you for taking our question. So on your end of phase two meeting, can you talk about what you’re hoping to discuss with the FDA and align with them on are you planning to discuss the possibility of an NIT based phase 3 design with them and will we get an update after this meeting? Thank you.
Dr. Scott Harris (Chief Medical Officer)
Hey Jasmine, thanks for the question. I think that we really can’t provide a lot of details about the meeting and our proposals until we actually have the meeting. And there will be a lot of topics to discuss. And you know, the opinions of the FDA on this are shifting right now and we’re keeping our ears very close the ground on this. So we expect to be able to have a very rich conversation with the FDA along multiple lines of approaching this and have an update for you after the end of the Phase II meeting.
Analyst
Okay, awesome. Thank you.
OPERATOR
Thank you. Our next question coming from the line of Yasmin Rahimi with bypass handler. Your line is now open.
Analyst
Hi, this is Dominic on for Yasmin Rahimi. Congratulations on a great quarter and thank. You for taking our question. So we just had a few questions. The first one, was there any measures. On alcoholic consumption in the IMPACT Study that could de risk, reclaim and restore. And then kind of going with that. What is the timing for those readouts. And what do you need to see. To advance in the phase three?
Dr. Scott Harris (Chief Medical Officer)
Right. So you know, we are continuing to analyze the data sets from the IMPACT trial and we’ll have an update on any alcohol measures as we continue to provide data. As you know, we’re continuing to analyze the results of the trial and we’ll provide on that information as we further analyze the data. We think we have a great deal of evidence for the effects of penvedutide on AUD and ALD. As you’re aware, we have a very impressive animal study showing about an 80% drop in alcohol consumption in animals who were given free choice. As well, there’s a huge literature on the effects of GLP1 agents in alcohol consumption, both observational trials and at least one randomized trial. And as you know, with ALD, the pathophysiologic basis of that is fat induced liver inflammation, very similar to mash. So, you know, we feel very confident of our ability to hit the endpoints in both the AUD and ALD trial and in terms of the Phase 3 development program in those indications. We’ll meet with the FDA after the Phase 2 results and get agreement on what that program looks like. Thank you.
OPERATOR
Thank you. Our next question coming from the line of Roger Song with Jeffreys, your line is now open.
Jefferies Analyst
Great. Congrats for the progress and thank you for taking our question. Maybe just also on the end of phase meeting, how much more work you need to do before you can request the meeting? My understanding you have not requested the meeting. How much data from the 48-week readout is needed to finalize the Phase 3 design proposal? And then I have a follow up question. Thank you.
Dr. Vipin Garg (President and Chief Executive Officer)
Yeah, Roger, we feel very good about having that meeting by the end of the year and we’ll have the results of that meeting and share it with the Street. Other companies have met with 24 weeks of data and I want to remind you that we have a lot of information on 48 weeks of data and dosing from our obesity momentum study. So consequently we don’t really. We feel confident that we’ll have the data to go in and we’ll have that meeting. We should have it sometime in the fourth quarter and we’ll inform the street on what the results of that meeting were.
Jefferies Analyst
Got it. Thank you. And then my follow up question is with the new chairman appointment, so how will the corporate strategy evolve regarding the partnership for Phase 3 and commercialization? It seems you’re more focused on the commercialization now. Thank you.
Dr. Vipin Garg (President and Chief Executive Officer)
Yes, that’s as you can imagine, that’s part of the natural evolution. The board is continuously evaluating the skill set at the board level. Given that we are now moving into phase three, the board felt that addition of bringing Jerry as chairman would be an added advantage for the management team to move forward. So his experience in domain area, in building a liver disease company and ultimately being part of that M&A transaction would be important as we, as we move forward. Kada, thank you.
OPERATOR
Thank you. Our next question coming from the lineup. Katherine Okakoni with Citizens. Your line is now open. Hi, this is Katherine on for John.
Citizens Analyst
I have a quick question about the the T1 responses and how the results from IMPACT compared to other programs. I know that you said kind of best-in-class, but if you could kind of give us some kind of ranges from the other competitor programs. Thanks.
Dr. Scott Harris (Chief Medical Officer)
Yeah, Catherine. So as you’re aware, the results that we have were in the range of a reduction of about 145 to 140 milliseconds that was seen in this trial, but was also seen in a prior trial or phase 1b trial in patients with fatty liver. And based on the public data, we’re seeing readouts of approximately 50 to 60 for rezmudirom and up to about 107 for tirzepatide. So you can see that these results that we’re getting 147 versus a range of 50 to 107 are clearly superior to other compounds, at least those that are reported in the public domain. In that given the association of CT1 with reduction of both MASH activity and fibrosis, that this is one other measure among many measures showing the potent anti inflammatory and anti fibrotic activity of the compounds.
OPERATOR
Great, thank you. Thank you. Our next question coming from the line of Patrick Tukio with H.C. wainwright. Yolande is now open.
HC Wainwright Analyst
Hi, good morning and congrats on all the progress. I just have a couple of follow up questions on expectations around the Phase three program and and then as well just maybe looking further ahead to potential commercialization and the product profile that’s emerging. I guess the first part of the. Question is just around kind of updated thoughts on dosing strategy. 1.2 milligram, 1.8 milligram and then the higher dose and how you’re thinking about the dose selection for the phase three and then as well for the primary endpoints. How are you thinking about primary endpoint? Co primary endpoint, you know, would NASH resolution as primary with fibrosis improvement or would there be a co primary design? And I guess how would you power for both? And then just as it relates to just the commercial potential, just based on, I mean there’s a lot of data and I think there’s a lot of. Points of differentiation here. So if the phase three were to reproduce the impact efficacy and tolerability, I guess how do you see the positioning in MASH if there’s an eventual approval?
Dr. Scott Harris (Chief Medical Officer)
Patrick, I’ll take the first part of the question for the commercial potential. I’ll turn that over to Vippin. So as you were aware, we studied the 1.2 and the 1.8 milligram doses in impact and even at the 1.8 milligram dose, which is not our most potent dose for weight loss, we still achieve 6.2% weight loss at only 24 weeks. And the trajectory of the weight loss indicated there was a lot more weight loss to be had. So we think it’s going to be very attractive to put the 2.4 milligram dose into phase three would not only give more weight loss to the extent that it could promise even more, provide even more efficacy, we find that very attractive. Regarding the other two doses that’s currently being looked at very critically and we’ll discuss that with the agency and have an update for the street after we have our end of phase two meeting. As you’re aware, there are two endpoints in MASH resolution and fibrosis improvement. In the IMPACT study we had a dual endpoint, meaning that we either had a hit MASH resolution or fibrosis improvement for the trial to be successful and consequently IMPACT was a successful trial. We could go in to phase three with a similar strategy of dual endpoints. There’s also the possibility of CO endpoints when you have to hit both, et cetera, and then in the background you have endpoints based on non invasive tests, which we feel are very exciting. And by the way, EMA has approved the use of a path AI methodology for actually reading out NASH resolution and fibrosis improvement using computerized algorithms assisted by the pathologist, but driven predominantly by the computer, which we think is going to reduce greatly the noise that we’re seeing in the trial and probably help us control the placebo response and really express the anti fibrotic potential of the compound. So we think there’s a lot of things at play here in terms of the discussion with the fda. It’s going to be a very exciting and important end of phase two meeting. And as soon as we have further information, we’ll update the street. So with that I’m going to turn the commercial discussion over to Vipin.
Dr. Vipin Garg (President and Chief Executive Officer)
Yeah, I just want to emphasize one other thing with regards to the FDA discussions. You know, one thing I want to remind everybody is that we have a very large safety database that we have already accumulated on Pemveduta. It’s a part of our discussion with would be how do we leverage that? We think there is an opportunity to reduce the number of exposures in terms of the safety database. So we’ll certainly be having that dialogue with the fda, as Scott said, among many other things that we’ll be discussing with the fda. So looking forward to that. Patrick, in terms of commercial potential of pembidutide, as we have said all along, and as you pointed out, the multiple potential points of differentiation, first and foremost, we are combining two mechanisms. Direct action in the liver, a direct acting agent in the liver with a metabolic agent with weight loss. So really think of it. We’re treating NASH with obesity. And when you look at the MASH landscape, everybody’s talking about the benefit of adding weight loss on top of liver directed effect. We’re bringing that in single molecule. We’re combining these two mechanisms. So we’re treating MASH, but on top of that people are losing weight. 60 to 80% of patients with MASH are obese or overweight, so they would benefit from losing weight. So that’s Number one, which we believe is a very big advantage or differentiating factor for pemvidutide. You know, in our work, in our market research, it’s clear that physicians are looking for a drug where people will not only improve their liver health, but will also lose weight. Secondly, safety and tolerability is going to be very, very important. And as you can see from our data, we are seeing class leading tolerability profile. We think that can be leveraged. Patients like that, doctors like that, lack of dose titration is going to be a major plus when we go, when we commercialize pemvidutide. So it’s really the benefit of combining the two mechanisms and on top of that having a very clean safety and tolerability profile that we think is going to speak well in terms of the commercial success of the product.
HC Wainwright Analyst
Great, thanks so much.
OPERATOR
Thank you. Our next question coming from the line of Myong Montani, would be wireless securities. Your line is now open.
Analyst
Hi, thanks for taking our questions. This is William on for Myong today. Two from us. Maybe I’ll start with the first. So now that we know that Lily. Has gotten positive FDA buy in on pursuing high risk masld, a high risk MASLD (Metabolic Associated Steatohepatitis Liver Disease) trial for their Retta and Tirzepatide. They’re using NITS for patient screening and then foregoing biopsies completely for primary FSP (FibroScan Performance) endpoint and looks like even in the trial looking more of an outcomes type trial. How do you see this as an opportunity for PENVI to execute on a capital efficient phase three trial? And is your understanding that this still only biopsies are a way to secure subpart H accelerated approval? And then I have a follow up.
Dr. Scott Harris (Chief Medical Officer)
Well, thanks, William. Yeah, I mean I think it’s really exciting. I think it creates a real opportunity for us in non invasive tests. And you know, we’re taking a very careful look at that and we think that there’s real opportunity for us here and we’ll certainly have that discussion with the fda.
Dr. Vipin Garg (President and Chief Executive Officer)
Yeah, as we have said and then we will look at every potential opportunity to come up with an innovative trial design and incorporate all of these things that are now becoming clear that the FDA is. So we’ll certainly have all of those discussions. We can’t get into the specifics right now, but we’ll definitely talk about it once we’ve had the end of phase two meeting.
Dr. Scott Harris (Chief Medical Officer)
Yeah. Let me add to that William, that you know, there are a lot of exciting things happening here. The development of nits, the movement toward AI based reading in Europe and we think there’s a good chance that FDA will pick that up. And you saw that we had very positive results from the AI based analyses that really reduce the noise from the manual pathologist readout. So there are other developments here that are going to increase our probabilities of success in phase three. And you know, we’re very interested in those and share your excitement and plan to have that discussion with the FDA this fourth quarter.
Analyst
Got it. And then also again, I was sort of thinking of Crosstown Pier. Merck has their efinopegdutide readout coming out shortly and they’re looking at biopsy results at 48 weeks. Slightly different glucagon ratio here. But what could their data mean in terms of your 48 week data potentially in Phase 3 or obviously just your NIT data coming up the end of the year? And what may you be specifically looking for to bring you additional confidence in Phase 3 sort of going forward? And what will guide you, help guide you in development of that Phase 3?
Dr. Scott Harris (Chief Medical Officer)
Right. Well, as you noted, William, the reading out at 48 weeks and another glucagon compound is read out at 48 weeks. And these have lesser ratios of glucagon. And as Vipin mentioned, we read out at only 24 weeks. So we think that our readouts at 48 weeks, had we done the biopsied week 48 weeks, would has been as good, if not better than the other compounds. And that’s certainly supported by the very potent noninvasive test results we’re seeing at week 24. I want to remind you that there hasn’t been an incretin, let alone a glucagon containing incretin that is read out at week 24. And at week 24 our match resolution was comparable to or superior to other compounds at week 24 and better than compounds reading out at later time points in 48 to 72 weeks. So we think that a efinopegdutide readout will be further confirmation of the efficacy of the compound. Now, as you know, we don’t have a biopsy at week 48, but we have the noninvasive test and we expect to be able to use the non invasive test to model and to predict what we would have seen a week 48 had we done the 48 week biopsy. So, you know, we think that data will be very supportive of our mechanism and our efficacy.
Analyst
Got it. Thanks for that color. I’ll hop back in the queue.
OPERATOR
Thank you. Our next question coming from the lineup. Corinne Johnson with Goldman Sachs Heal ON is now open.
Goldman Sachs Analyst
Good morning. Maybe just one from us. How should we think about the cadence of research and development spend from here as these AUD and ALD studies studies get up and further running and enrollment increases? Thanks. Thanks. Appreciate the call.
Greg Weaver (Chief Financial Officer)
This is Greg. And in terms of the R and D spend investment in AUD and ald, these are phase two trials. They’re baked into our budget for this year, so they’re incorporated in our cash Runway. These are relatively modest in size and we’re on it. Don’t anticipate anything unusual in our burn rate going forward in the near term as related to AUD and ALD.
Goldman Sachs Analyst
Okay, thanks.
OPERATOR
Thank you. Our next question coming from the lineup. Anshu Jain with William Blair. Your line is now open.
William Blair Analyst
Thanks for taking a question. Just a quick one. Very interested in the oral program that you are advancing. So I’m curious, maybe from a technological perspective, we think about it as a gastric absorption enhancer. And also just curious if you can. Tell us a little bit more about. How you would position this formulation in the grand scheme of things. Thank you.
Dr. Scott Harris (Chief Medical Officer)
Thanks for the question. You know, we’ve been at this for a little while here and, you know, I’m excited to share that we’ve had a big breakthrough in the activity. You know, from the very beginning, we focused on two elements to really differentiate an oral formulation of the peptide from others that are out there. Robelsis, for example. The first is to get away from the food restriction. You know, you mentioned gastric absorption. That’s exactly what we’re trying to get away from. And we’ve done that from the beginning and focused on that because when it’s absorbed in the gut or in the stomach, then it’s really about, you know, very tight food restrictions that you’re aware of for the Rybelsis indication. So that’s one of the things we wanted to do. And the secondary feature was to make sure that it really made sense from a cost of goods standpoint. As you know, oral absorption is always inefficient compared to subcutaneous injection. But to make it work, we had a fairly high threshold for what we would be interested in. And so I think that things are looking very, very good in that respect. You know, I think this breakthrough that we had was mechanism based that it went just the way we expect and we looking forward to translating that into a preclinical development and nomination there. So as far as the impact to the commercial situation, I’ll let Vipin speak to that.
Dr. Vipin Garg (President and Chief Executive Officer)
Yeah, I mean, our strategy with the oral program is very similar to what you would expect with what’s being done with other programs. Really a life cycle management question. As this field grows, there would be attractiveness to the oral program. As Scott mentioned, oral delivery is never going to be as efficient as subcutaneous injection. So we believe that both of these formulations would be important in terms of developing commercially the value proposition around pemvidutide.
William Blair Analyst
Thank you.
OPERATOR
Thank you. And there are no further questions in the queue at this time. I will now turn the call back over to Dr. Vipin Garg for any closing remarks.
Dr. Vipin Garg (President and Chief Executive Officer)
Thank you all for joining our call today. As always, we appreciate your continued support and look forward to keeping you updated in the months ahead. Have a wonderful rest of the day.
OPERATOR
This concludes today’s conference call. Thank you for your participation. And you may now disconnect.
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