Altimmune, Inc. (ALT) on Q2 2021 Results - Earnings Call Transcript
Operator: Good day, ladies and gentlemen. And welcome to the Altimmune Incorporated Q2 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. If anyone should require Operator assistance, please press *, then 0 key on your touchtone telephone. As a reminder, this call may be recorded. I would now like to introduce your host for today's conference, Will Brown, Chief Financial Officer of Altimmune. Will, you may begin.
Will Brown: Thank you, Operator. And good morning, everyone. Thank you for participating an Altimmune Second Quarter 2021. Earnings Conference Call, leading the call today will be Vipin Garg, our Chief Executive Officer. I will also be presenting during the call, as well Scot Roberts, our Chief Scientific Officer, Scott Harris, our Chief Medical Officer. Following the prepared remarks, we will hold a question-and-answer session, a press release with our Second Quarter 2021 financial results was issued last night and can be found on the IR section of the Company's website. Before we begin, I would like to remind everyone that remarks about future expectations, plans, and prospects constitute forward-looking statements for purposes of Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. All coming cautions that these forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those indicated, including those related to COVID-19 and its impact on our business operations, clinical trials and results of operations. For a discussion of some of these risks and factors that could affect the Company's future results, please see the risk factors and other cautionary statements contained in the Company's filings with the SEC. I would also direct you to read the forward-looking statement disclaimer in our earnings press release issued yesterday and now available on our website. Any statements made on this conference call speak only as of today's date, Wednesday, 11th August, 2021. 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 website. With that, I will now turn the call over to Dr. Vipin Garg, Chief Executive Officer of Altimmune.
Vipin Garg: Thank you, Will. And good morning, everyone. We appreciate you joining us today for a discussion of our Second Quarter 2021 financial results and business update. I want to begin today's call by thanking our employees, our collaborators, and our investors for the tremendous dedication and support they have shown to Altimmune over the last 18 months. In January 2020, upon studying the emerging reports of the devastating COVID-19 virus, our R&D team sprang into action in our labs and began creating a COVID-19 vaccine based on our inter-nasal platform technology. Our encouraging data with our Phase 2 clinical trials with NasoVAX gave us confidence that an inter-nasal vaccine could be effective in protecting individuals against this new respiratory virus. Through the most uncertain days of the pandemic and quarantine, our employees and collaborators answered the call to this global crisis through extreme dedication to the task at hand that came with tremendous personal sacrifice of time with family and loved ones. I was proud and inspired by their resiliency and result. Through this work, our confidence was bolstered that AdCOVID could have great potential as a new mucosal vaccine. As we gather positive animal data, including a potent induction of local mucosal and systemic immune responses and demonstrated efficacy amidst the SARS-CoV-2 virus. However, far too many times in our business, we see product candidates that work extremely well in animals, but do not translate to humans. And unfortunately, that was our experience. We were extremely disappointed at the Phase 1 AdCOVID data, and we had to take an honest look at the viability of performing, performing continued experiments and clinical tests at a time when the MRNA and other vaccine approaches were working so very well. And during an efficient vaccine, low out an update rate by the general public that will surely stand as a remarkable achievement in the history of vaccine development. We applaud the efforts of the global pharmaceutical community in swiftly developing these new vaccines. With this backdrop of success and always seeking to be good stewards of the resources intrusted to us, we made the swift decision to terminate the Ad COVID program. As you have heard us say many times, one of the central tenants of our philosophy is to maintain and develop a diversified portfolio of assets to ensure that we are positioned for success no matter what transpires with one -- with any one of our product candidates. That philosophy has served us well in 2021 with the clinical development of ALT-801. Our GLP-1 glucagon dual-agonist for the treatment of obesity and NASH. As Scott Harris will more fully described, they saw significant weight loss in just six weeks in our Phase one study with no serious GI side effects. This fuels our enthusiasm and excitement for all data 1 especially in light of the recent successful commercial launch of semaglutide for the treatment of obesity. It's further encouraging to compare our 6-week interim results against other Phase 1 clinical trials with similar agents. Noting that we are at the top of the class in terms of weight loss and tolerability at 6-weeks, and without the need for dose titration. With this data, we gain the confidence to launch an additional program with ALT-801 in obesity, and we expect to file an IND in the Fourth Quarter to enable a Phase 2 trial in obesity, which will follow our previously announced IND for NASH in the Third Quarter. For the remainder of 2021, we look ahead to our Phase 1 ALT-801 12 week data from Australia which we anticipate reporting in September. Following this trial are several studies to further explore the effects of our drug in natural D and diabetic subjects along with their study to test the interaction of ALT A21 with drugs commonly administered to obese and diabetic subjects. These studies will enable meaningful Phase 2 trials in both NASH and obesity with large studies planned to begin in early 2022. Our other assets within delivered spaces, HepTcell (ph), an immunotherapeutic for chronic hepatitis B, that is in Phase 2 development We haven't HepTcell, one of the most clinically advanced immunotherapy candidates. And we are in the midst of executing on this international trial. We currently have sites in Canada, U.S., Germany, and Spain to follow patients in a six month dosing regimen. Considering the time to enroll HBV patients in this COVID environment and the duration of dosing, we expect to have data in the second half of next year. So, in Q3 2021, we'll now turn the page to the next chapter of Altimmune. With our focus formerly on obesity, NASH, and chronic hepatitis B, with exciting drug candidates and then enviable cash position with which we can quickly advance through several near-term data catalyst. With that, I'll now turn the call over to Scott Harris to discuss our 6-week data. The upcoming 12-week data readout and subsequent advanced trials. Scott.
Scott Harris: Thank you, Vipin. And good morning, everyone. During June, we shared results from our 6-week interim analysis of two cohorts from the ongoing 12-week Phase 1 placebo controlled single and multiple ascending dose study of ALT-801. The study is being conducted in Australia and is enrolling overweight and obese volunteers. We reported 2-dose levels, 1.2 and 1.8 milligrams that were administered subcutaneously once a week for 6 weeks. The 6-week data reported weight loss and adverse events. The results we observed were very encouraging and have exceeded our pre-established treatment target of 2% absolute weight loss at six weeks, employing a 1.8 milligram subcutaneous, once weekly dose, we achieved a placebo adjusted mean weight loss of 6.3% in just 6 weeks of treatment with ALT-801. During the 6 weeks, ALT-801 was well tolerated with low rates of nausea and other GI side effects. Importantly, there were no patient dropouts at the 1.8 milligram dose level and the one patient at the 1.2 milligram dose that dropped out did so for reasons unrelated to drug. This is particularly remarkable, given the fact that we administered ALT-801 without the use of dose titration, which is the practice with virtually all other agents in the class, including the recently launched Wegovy. Gastrointestinal adverse events that have required these other GLP -- have required these other GLP-1 based candidates to dose titrate that is, to achieve the therapeutic dose only after slowly increasing the doses over 16 to 20 weeks to maintain adequate tolerability. While the 6-week data focused on weight loss and adverse events, and we will certainly report these measures with the 12-week data, we plan to also report data on a number of other measures, namely pharmacokinetics, lean body mass, caloric intake, resting energy expenditure, glucose homeostasis, insulin resistance, lipids, and inflammatory markers. We believe that the 1.8 milligram dose is likely the level at which we we show the most attractive combination of efficacy, safety, and tolerability. However, we are testing higher dose cohorts in the ongoing trial. And today, we announced that we will be reporting 12-week dosing results for the 1.2 milligram, 1.8 milligram, and 2.4 milligram dose levels. We recently completed dosing in these groups, and will take approximately 4 weeks to analyze and report the data. Accordingly, we expect to report the 12-week data on these cohorts in September, and we look forward to sharing this data with you. Looking ahead to further development, we are planning three additional trials to initiate this year. These trials are designed to address key questions regarding the activity of ALT-801 early in the drugs development. First, we're in the process of finally ALT-80 IND and NASH to conduct a 12-week Phase 1 B study of subjects with non-alcoholic fatty liver disease or NAFLD in the United States. This study will expand the enrollment criteria used in the aforementioned first-in-human study in Australia to include diabetic and older subjects, and commence around the end of September. Based on the relationship between weight loss and liver fat reduction observed in other GLP-1 based studies, and the additive effects of glucagon on liver fat metabolism, we are optimistic that ALT-80 will be an effective therapeutic agent for NASH. And that the reduction in liver fat in the plan 12-week NAFLD study will parallel the impressive weight loss that we have observed. Second, we are planning to initiate a dedicated type-2 diabetes trial to study glucose homeostasis in diabetics in Q4 2021. The study will be 12 weeks in duration, and we'll study endpoints, and that will include continuous glucose monitoring, hemoglobin A1C, and measures of insulin resistance such as (ph) IR 2, and adiponectin. We expect the observations of glucose control in our current Australian 12-week study to hold to true for the type 2 diabetes population as overweight and obese subjects like patients currently enrolled, typically exhibit insulin resistance in pre-diabetes. Since later stage NASH and obesity trials will likely include type-2 diabetics, we want to establish this inclusively. Finally, we're planning to initiate a drug-drug interaction trial. The FDA expected sponsors of GLP-1 based compounds to conduct studies evaluating the impact of alterations of gastric emptying on the kinetics of drug absorption. GLP-1 based compounds with extended half lives like ALT-801 have not been associated with these changes. ALT-801 is a peptide. So no significant interactions with cytochrome or transporters have been observed to date or are expected. As previously announced, we plan to file our second IND for ALT-801 in obesity during the Fourth Quarter to create a parallel development plan path to our ongoing NASH development. This IND, and the aforementioned trials, will enable significant Phase 2 clinical development during 2022. At this time, we're planning a Phase 2 obesity study, along with a Phase 2, 52-week biopsy driven NASH study, which could start in the First Quarter of 2022. We look forward to updating you on our Phase 2 plans later this year. It's ALT-801 is currently administered as a subcutaneous injection. Our development plan -- planning includes the use of an auto-injector that can be self-administered by patients and work is progressing on that front. Equally important, we have initiated development of an oral formulation for ALT-801. I'll turn it over to Scot Roberts, our Chief Scientific Officer for that discussion. Scot.
Scot Roberts: Thank you, Scott. One of the advantages we have with a molecule like ALT-801 is that it is an attractive candidate for oral formulation. Several of the GLP-1 base drugs currently in development are not suitable for oral formulation, owing to their large size. As ALT-801 is structurally similar to semaglutide, which has been successfully formulated for oral administration. We are optimistic about the eventual success of an ALT-801 oral formulation. We view an oral formulation of ALT-801 similarly to our improved tolerability profile and our ability to bypass protracted dose titration. Advantages that increased patient interest and compliance. We look forward to updating you on our progress towards this endeavor in the near future. Finally, I would also like to provide a brief update on our chronic toxicology studies designed to support our longer-term obesity and NASH efficacy studies. The studies are progressing well with overall observations consistent with the earlier shorter-duration studies. And we expect these studies to be completed in the Fourth Quarter to support the Phase 2 obesity and NASH trials planned for 2022. I will now hand the call over to Will Brown to give an update on our Second Quarter financial results.
Will Brown: Thank you, Scott. For today's call, I will be providing a brief update on Altimmune's Second Quarter 2021 financial and operating results. More comprehensive information can be found in our Form 10-Q filed with the SEC last night. Altimmune ended the second quarter with a strong cash position, reporting a balance of approximately 218 million of cash, cash equivalents and short-term investments compared to 216 million at the end of 2020. The increase in our net cash during the current period is attributable to 52.4 million of net receipts during the year Primarily due to our utilization of the at-the-market or ATM offering program offset by cash used for operating investing activities. With these resources and the termination of the AdCOVID vaccine program, we have sufficient cash to operate into 2023. Turning to the income statement. Revenue in the Second Quarter was a 137, 000, compared to 720, 000 in the Second Quarter of 2020. The change in revenue between periods is primarily due to a decrease in BARDA revenue, as we wind up activities under the current NasoShield contract. Revenue attributable to the T-COVID program was completely recognized as of the end of Q1 and we are currently collecting the related accounts receivable as we complete the activities under that contract. Research and development expenses were 13.3 million in the Second Quarter, compared to 16.6 million in the prior period. The change in R&D expense was primarily the result of $13 million in higher non-cash charges in the prior period related to changes in the fair value of continued consideration liability connected with the acquisition and development of ALT-801. This was offset by an increase of $10 million related to development activities for AdCOVID and other programs. General and administrative expenses were 3.7 million in the Second Quarter of 2021, compared to 2.5 million in the prior period primarily due to increased stock comp expense and additional labor related costs. We recognized approximately an $8 million impairment loss, impairment loss on construction and process during the Second Quarter, which represents an impairment charge recorded for assets that were previously capitalized in connection with the manufacturing suite under construction at Lonza. We have not yet terminated that contract and we are currently evaluating our options with respect to the space. Net loss for the 3 months ended 30th June, 2021 was 24.8 million or $0.60 net loss per share compared to 16.8 million or $0.94 net loss per share for the Second Quarter of 2020. The difference in net loss is primarily attributable to higher R&D impairment and G&A expenses. I will now turn it back over to Vipin for his closing remarks. Vipin.
Vipin Garg: Thank you, Will. Operator, that concludes our formal remarks and we would like to open the lines to take questions. Could you please instruct the audience on the Q&A procedure.
Operator: Your first question will come from the line of Seamus Fernandez with Guggenheim.
Seamus Fernandez: Great. Thanks so much for the questions. So I appreciate the update as it relates to the plans for the -- obviously, the historical program now for vaccine perspective. As you guys pivot to driving the Company towards being a metabolic disease Company, we've obviously seen the robust performance at 6 weeks. I think it would be helpful to just understand what you're hoping to see specifically in the 12-week data. And then in terms of the 2.4-milligram dose, I think that's right in line with our expectations for where you would increase the dose too. Again, I think in most cases that the increase in a dose would be 30% to 50%. So right in line with expectations. but how should we think about the relative opportunity for the 2.4-milligram dose. Is this really an exploration of the upper dose range more than anything? Or is it your hope that you could see incremental weight loss above and beyond what we've already seen at the 6 weeks with the 1.8-milligram dose? Or is your expectation to really see more of a trade-off of tolerability, given the contributions of GLP-1 to the mechanism? And then I have a follow-up question on your oral approach relative to that kind of technology, that's necessary to deliver a peptide orally.
Vipin Garg: Absolutely. Well, thank you, Seamus. Scott Harris do you want to take that?
Scott Harris: Good morning, Seamus. Our expectation for the 12-week data is that we'll continue to see a strong trend in weight loss. We haven't picked an actual number. I think the most important number is what we achieved, say at 40 to 52 weeks. We did a post on our corporate website the individual responses, which show the trends in the dosing. So we would project that those trends would continue through 12 weeks, which would signify those trends would probably continue to week 52. And that would be our expectation. And we'll also, as you know, have much more data that will be more mechanistic, such as calorie intake, resting energy expenditure, and lean body mass, as well as glucose homeostasis, that will not only project the efficacy of the compound, but really understand it, and understand what we're achieving with dosing. Regarding the 2.4-milligram dose, as you know, the dose --the results that we achieved with 1.8 milligrams, which is less than 2.4, we're already in our opinion spectacular. So it really didn't leave much to gain by dosing higher in terms of more weight loss. As we announced, the primary reason to dose higher was to establish the dose range which within we could work. As you go to Phase 2, you don't want to have Phase 1 obligations and we hadn't dose higher in for whatever reason, decided to go to that dose later, we'd have to go back to do another Phase 1 study or make a Phase 2 study look like a Phase 1. I think what we're really shooting for is greater tolerability. Excuse me, the range of tolerability, and the excepted safety range rather than achieving higher weight loss. Now, if we achieve higher weight loss, that would be great, but it would be hard to believe that we can achieve much higher weight loss than we got with 1.8 milligrams.
Seamus Fernandez: And just, I guess, on the oral, the technology that would need to be employed or can be employed to deliver this peptide technology, just hoping to get a better understanding of that. I think to our understanding, the technology is now 100% owns by Novo Nordisk. And it was only a single amino acid change between liraglutide and semaglutide that actually allowed for that products to be delivered and bioavailability, I think is still to some question for that products. Just love to know the technical approach that you're taking and if you've licensed any technology to be able to do that? And if so, if you wouldn't mind disclosing which technology that is? Thank you.
Vipin Garg: Scot Roberts.
Scot Roberts: Sure. Hey, Seamus. So one of the things that we saw right off when we were acquiring ALT data 1 was its suitability, potential suitability for all formulations. And with the 6-week data, validating the potency of this for a compound for our weight loss and presumably get mobilizing fat out delivers, we'll see in the NAFLD study. I think that that only becomes more important and more real for us. So we're very excited about this project. At a general level, the hurdles that have to be surrounded by anybody who is trying to make up a peptide orally, a is to get it through the stomach first of all and protect it from proteases. And then essentially, you need to create a Lipofilick environment for the peptide so that it can then cross the cell membrane in the intestine and enter the bloodstream and do its worked there. So there are a number of approaches, obviously, Novo Nordisk has used snack technology to achieve this. I'm not going to go into a lot of detail about the approaches that we're looking at here. We'll update you in the future, but suffice it to say that the similarity of our molecule to semaglutide, which is a small lipid full of chain, leads us to believe that we have a high likelihood of success here. So we look forward to updating you on that in the near future.
Seamus Fernandez: Great and --
Vipin Garg: And Seamus just adds that yes, indeed, we are looking at a proprietary technology to make this work. But at this point, we'll disclose it at the appropriate time late later on.
Seamus Fernandez: Okay. Great. I'll jump back in the queue out of respect for the other analysts on the call.
Operator: Your next question will come from the line of Yasmeen Rahimi with Piper Sandler.
Yasmeen Rahimi: Hi, team. Thank you so much for taking my questions, and thank you for the updates. Few for you. Maybe a good place to start would be just providing us with some color on the size of how many patients per cohort we should be seeing data. I went back to your corporate deck and it refers to the obesity steady to be a 100 patients who nicely show the patient per patient weight loss in the 108 -- 1.8 milligram, which is 9 patients and foreign placebo. As we head into September, can you draw -- can you provide color for me? How many patients are in placebo? How many are within reach of the 3-dose cohorts? That could be very helpful. And then I have two follow-ups for you.
Scott Harris: Right. Hey, Yasmeen. Good morning. We are enrolling 10 to 15 per cohort. And the randomization ratio between those who receive ALT-801 and those who received placebo is 4-1. So it obviously varies a bit between cohorts, but that will be the general advice that we were given.
Yasmeen Rahimi: Okay, another question for you is around expectations and weight loss going into week 12. When we look at historical data comparing weight loss and an overweight population that is non-diabetic. You see the magnitude to be two-fold. I guess why can we not make the assumption? Maybe correct me wrong. You are getting 6% at Week 6, should you be getting at least over 10% at week 12? And the significance of that, like is there a chance that that might not fall in and that there is not a linear relationship between week 6 and week 12. So if you could just comment on that, that would be helpful.
Scott Harris: Right. So, I think the most important thing is that to the eye of the trends are continuing. If we focus on specific numbers, especially with small numbers, we may not really get the right impression. So I think the most important thing is that visually when you look at the data, you're convinced that it's linear. That it's continuing. And that we don't actually cite a specific number and we think that that will be the right approach. I just don't want us to get hung up on a decimal place for success.
Yasmeen Rahimi: Thank you. And then can you comment on as of right now, if any -- at what your discontinuation rates have been? I know when you reported 6-weeks of data, there was 1 patient that discontinued. Are you able to comment on sort of the discontinuation rate as of right now?
Scott Harris: Yes.
Yasmeen Rahimi: Your study?
Scott Harris: We haven't been public on that, Yasmeen. We obviously will with the 12-week data.
Yasmeen Rahimi: Okay. And then I just want to understand maybe the thought process behind -- I know you are plan -- you have said that you're starting a 52-week NASH study in the first quarter. So as of right now, is the 52-week tox package complete, or at what point are you, so that you're on track as soon as IND is clear to kick off the 52-week data? So, it's maybe a little not clear to me.
Scott Harris: So let's go through the timeline quickly. The IND for NASH will be filed imminently. As Scott mentioned during his presentation, we have completed it obviously, talks up to 13-weeks that enables our 12-weeks of dosing. And we are in the process of completing the chronic rat and Cyano(ph) talks that will enable. a long-term NASH studies. So that will be completed later this year well in advance. That tox study will be completed later this year well in advance of either a 52-week NASH trial or a long-term obesity trial. So there is a comfortable timeline there that we feel comfortable about hitting.
Yasmeen Rahimi: Thanks. I will jump into the queue. Thanks.
Operator: Your next question will come from the line of Kelechi Chikere with Jefferies.
Kelechi Chikere: Good morning, and thank you. Just two questions on my end, I guess, based on the current pre-clinical and clinical data, is your expectation that you would use the same dose in both Nash and obesity? Just trying to get a sense of that, given that the glucagon component of ALT-801 has been official effects on the liver. So, just trying to determine there what the dose could potentially be?
Scott Harris: Right. So the initial answer to that question, Kelechi, would be yes. We do expect the doses to be similar, but you brought up a good point that Glucagon has independent effects on overweight loss. So potentially, the dose in NASH could be lower, but recognize that when you're treating NASH, you're not just treating deliver, you're treating the whole patient so that we would think that we would try to administer doses to NASH patients that would not only achieve optimal fat reduction in the liver but also optimal weight loss because of the non-hepatic comorbidities.
Kelechi Chikere: Got it. Thank you. That's very helpful. And I guess my second question, big picture, wanted to get your latest thoughts on the development and potential commercialization of 801 in these two large indications, I guess particularly as it relates to partnering. Is that a possibility? Are you having those discussions right now? And based on those discussions, if you're having them, do you have a sense of the type of data -- the type of data partners are hoping to see.
Vipin Garg: Hey Kelechi, this is Vipin. Yeah, so, in terms of thinking long-term strategically, as you can see the kind of trials that we're designing, our goal is to answer as many critical questions as possible. And the idea really is to build significant value in this asset quickly at this point, we just have Phase 1 data from 6 weeks, obviously, 12-week data is important, but then we've designed a number of studies that will answer some critical questions. We do know -- one thing we do know is that there is significant interest in assets like this from large players, from strategic partners. I can name a dozen companies that would be interested in this. So at this point, we're keeping all our options open. We are in a good position to execute this plan. So we've got a lot of optionalities and we will continue to monitor the situation. Our goal is to increase the value of this asset over the next 12 months. Let's say 12-18 months, and as more data becomes available, we are -- there is no doubt that they would be interested in an asset like this from multiple players.
Kelechi Chikere: Got it. That's very helpful. Thank you.
Operator: Your next question will come from the line of Mayank, with B. Riley Securities.
Mayank Mamtani: Thank you. Good morning, team. Thanks for taking our question. I appreciate the resilience and a data-driven approach to advancing your pipeline. So just quickly on the ALT-801 program, could you maybe just comment on whether the 6-week -- was there a built-in look for the 6 weeks 2.4 make dose level, or you're just going out to the 12-week there? There was no interim analysis there.
Scott Harris: Right. Kelechi, there was no interim --
Mayank Mamtani: Mike. Mike.
Scott Harris: I'm sorry, Mike. Mike, there was no interim analysis on the six-week interim analysis and the 2.4-milligram dose.
Mayank Mamtani: I understood. And then on the -- trying to understand the expectations for the Phase 2 B -- excuse me, the 12-week NASH study. What could we glean out of these 12-week obese nondiabetic patients, if anything, given what their base lane LFC or liver enzymes might be? And should we expect to -- should we look to learn anything on the refrac? For example, from this 12-weeks readout in September?
Scott Harris: Right. So I'll start by saying that we think the results from this study will translate to other populations. We know that based on the page subject profile, their age, and BMI. These attributes of translated in the semaglutide trials through very good results that long term readouts. We did not assess liver fat content in this trial. So I really can't comment on that, and because this is not a NASH population, I wouldn't expect that we would have enough baseline ALT elevations to make -- to see much of a signal or make much sense of something that would predict results in NASH. I think that the amount of weight loss we're seeing will clear, by itself, independent of any specific look at liver fat, based on the studies we know with, let's say 10% weight loss, but that's over a long period. Something that we could be achieved much sooner than that, that that should project to a beneficial effect in NASH.
Mayank Mamtani: Great. And then just on the preclinical docs work that is going on, particularly for the INDs, the 2 more visible INDs And then maybe for the oral GLP-1. Could you just comment on what might be the requirements here that at different for NASH versus obesity? I'm sorry if I missed that. Is it just related to the chronic tox or is there something else that goes into it? And then maybe just comment on what might be the IND timelines for the GLP-1 glucagon.
Scott Harris: There are two questions there. The first would be that the talks that we're doing right now will enable both the NASH program, the NASH IND, and the obesity IND. Okay? Actually, the obesity -- the NASH IND will be followed before the tox work based on the prior tox work, the chronic tox study will specifically enable the longer-term NASH and obesity trials, but will enable both. In terms of the IND for the oral formulation, we haven't been public in that. Obviously we're doing studies right now to look at that. and once we have specific guidance and when we would be able to fall an IND, we'll let you know.
Vipin Garg: Yes. My This is too early to project in terms of when we might be going into IND on oral. We hope to update everybody to what the end of the year is, in terms of our progress with the oral ALT-801. And then, based on that, we'll figure out what would be the timeline for filing an IND and update folks accordingly.
Mayank Mamtani: Great. And within just do on the higher level of vision here for the the program, do you have any early thoughts on -- given everything you learn on this next year at some point, what you may want to do internally versus what maybe effort by an external partner because you do have different indication, different formulations. Obviously, it's going to require a turn of capital to realize the maximum value here. Any early thoughts on what may be relatively more attractive to you here?
Vipin Garg: Yeah, so that's a good question, Mayank. Obviously, first thing first, we need to generate all the data that we're talking about. We are well funded in terms of reaching all these milestones. And that data will really guide us should we proceed with obesity ahead of NASH, for instance. I mean, that question we will address right now. We think there is value in both of these indications. So that's why we're pursuing them in parallel and generating all that data because that would be important for anybody to be able to value this program, and make that determination as to do we go after both of these indications, or do we go off to one before the other. So that's really the focus right now. But over time, as the data becomes available, we'll certainly be able to make a call in terms of which indication we pursue ahead of the other.
Mayank Mamtani: Great. Thanks for taking my questions.
Operator: Your next question comes from the line of Jon Wolleben with JMP Securities.
Jonathan Wolleben: Good morning and thanks for taking the questions. Just a couple from me. When we think about the 12-week readout and the new biomarkers we'll be getting. I was hoping you could provide some color on which will be particularly informative and that could give more differentiation from 801 versus the other GLP-1 candidates that we've seen?
Scott Harris: Hey, Jon. This is Scott. Again, thanks for joining the call this morning. I think that all of the readouts will be informative. We recognize they're based on small numbers of subjects. So based on the amount of variability we've seen within each of the measurements, there will be a higher or lower contributory to the overall program. I think the things that we want to understand based on the readouts is glucose homeostasis, is this point more for safety than for efficacy? We want to make sure that we're not being disruptive to glucose metabolism. Obviously, if we see a beneficial effect, it will be very helpful. We've already talked about the fact that the best way to control diabetes over the long term is to lose weight. So we're optimistic that over the course of a year that we're going to have better control of diabetes regardless of what we see in the beginning. But I would emphasize that we haven't seen any evidence of any loss of glucose control in healthy volunteers we're studying right now. Mechanistically, we'll look at insulin resistance that will help us understand the changes in or the glucose homeostasis that we're seeing. And whilst we get some mechanistic information that'll help us look at the relative balance of the GLP-1 versus glucagon effects. And I think those are going to have to be interpreted rather than necessarily driving specific messaging. Calorie intake should track with the GLP-1 component of the molecule whereas resting energy expenditure and ketone bodies, let's say would track with the glucagon component. And there will be some other things that we'll look out such as inflammatory markers as well. I think all-in-all, all of them will probably give us a much better feel for the compound. But what we're emphasizing here is the primary readout of importance is going to be the weight loss. I think that's what's really driving how we're going to apply the molecule, how we envision the molecule, and how we designed studies in the future.
Jonathan Wolleben: Got it. And for the diabetic study. I know historically, we see differential weight loss responses in diabetics versus non-diabetics. Do you have any sense on what degree you might see a difference there that's going to be in line with what we've seen historically? Or there might be some differential response based on ALT-801 activity or relative GLP-1 glucagon, specificity.
Scott Harris: That's a great question. Historically, if you take all the compounds, I'm talking about through (ph), semaglutide and to some extent although it's early a GLP-1 with a little glucagon, typically seeing about 60% of the weight loss in diabetics that you would see a non-diabetics. That would apply to those compounds which are predominantly GLP-1 based. Would that translate to the weight loss that we would see in diabetics with our molecule? We don't know it's a different molecule. It's somewhat unique in that it's not only a GLP-1 glucagon co-agonist, it's one-to-one. I think that in terms of general description, yes. Based on the literature you'd expect to see less weight loss in diabetics, but we have a different compound. We're just going to have to see what we see in diabetics and whether we get better weight loss than the other compounds that had previously been studied in diabetics.
Jonathan Wolleben: And one more, if I may, just on timing of data. The 12-week Phase 1b in NAFLD patients. Do you want to see that data before starting the 52-week biopsy for any kind of information for design or inclusion criteria, or when is that data going to come relative to the start of the 52-week studies?
Scott Harris: We'll have that data before the start of the 52-week study, whether we wait for the full readout at 12-weeks or do an interim analysis to drive the decision-making. we'll have to make that decision, but right now, we could wait for that data, or we could take an interim cut to look at the data.
Jonathan Wolleben: Got it. Thanks for the color.
Operator: At this time, there are no further questions. Do you have any closing remarks?
Vipin Garg: Yes. Thank you, everyone, for participating today. We appreciate the opportunity to share our results and outlook with you and thank you for your continued interest. Have a nice day.
Operator: Ladies and gentlemen. Thank you for participating. You may now disconnect.
