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spk09: Good day, ladies and gentlemen, and welcome to the Altamune Inc. full year-end Q4 earnings conference call. At this time, all participants are in 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 star then zero on your touchtone telephone. As a reminder, this call is being recorded. I would now like to introduce your host for today's conference, Rich Eisenstadt, Chief Financial Officer at Altamune. Rich, you may begin.
spk02: Thank you, Jonathan, and good morning, everyone. Thank you for participating in Altamune's full year and fourth quarter 2021 earnings conference call. Members of the Altamune team joining me on the call today are Vivian Garrett, our Chief Executive Officer, Scott Roberts, our Chief Scientific Officer, and Scott Harris, our Chief Medical Officer. Following the prepared remarks, we will hold a question and answer session. A press release with our full year and fourth quarter 2021 financial results was issued this morning. and can be found on the investor relations section of the company's website. Before we begin, I would like to remind everyone that remarks about future expectations, plans, and prospects constitute forward-looking statements for purposes of safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Alderman 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 discussion of some of the risks and factors that could affect the company's future results, please see the risk factors and other cautionary statements contained in the company's filings with the SEC. I would also direct you to read the forward-looking statement, disclosure, and our earnings 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, Tuesday, March 15, 2022, and the company does not undertake any obligation to update any of these forward-looking statements to reflect events or circumstances that occur on or after today's date. As a reminder, this conference call is being recorded and will be available for audio replay on Altamine's website. With that, I will now turn the call over to Dr. Vipengar, Chief Executive Officer of Altamine.
spk06: Thank you, Rich, and good morning, everyone. We appreciate you joining us today for a discussion of our year-end and fourth quarter 2021 financial results and business update. 2021 was a very productive year for the company as we achieved a key phase one data set in the development of our lead product candidate, Pembidutide. We announced positive data from a 12-week phase one placebo-controlled single and multiple ascending dose trial in volunteers with obesity and overweight that showed a mean weight loss of 10.3% was achieved with a 1.8 milligram once weekly subcutaneous dose. with no serious or severe treatment emergent adverse events or discontinuations for adverse events. Moreover, this favorable tolerability profile was achieved without the need for dose titration. We also demonstrated a greater than 90% reduction in liver fat content in subjects with hepatic steatosis, with liver fat decreasing below the limit of detection after only six weeks of treatment. In the fourth quarter of 2021, we announced that we initiated a 12-week phase 1B trial of pembidutide in subjects with non-alcoholic fatty liver disease, or NAFLD. That trial is ongoing at multiple sites in the United States with Dr. Steven Harrison, a renowned expert in the field of NASH and liver diseases, serving as the principal investigator. Enrollment in this trial is over 90% complete, and a data readout is expected in the third quarter of 2022. In addition, we initiated a 12-week extension to this trial, which when combined with the first trial, will allow subjects to receive treatment for up to 24 weeks. This will enable comparison to the weight loss achieved with semaglutide and trizepatide at the six-month time point. We expect to report this important readout in the fourth quarter of 2022. Early this year, we received IMD clearance from the FDA to evaluate pambidutide for obesity, and we are preparing to commence enrollment in the 48-week Phase II Momentum Trial of Pembidutide in Obesity later this month. The name reflects the rapidity of weight loss and Altimmune's firm commitment to the treatment of obesity. An interim analysis is planned to assess changes in body weight after 24 weeks of treatment, with data expected in the fourth quarter of 2022. This means that we expect to have 24-week readouts on weight loss from two separate clinical trials of pembidutide in 2022. Looking to other studies in 2022, we recently initiated a 12-week trial to characterize effects of pembidutide on glucose control in subjects with type 2 diabetes as a follow-on to our recently completed first in human phase one trial where we demonstrated excellent maintenance of glucose control in subjects with prediabetes with concomitant decrease in insulin resistance. We are also completing a phase one drug-drug interaction trial to evaluate any potential interactions of pembidutide with commonly used drugs. The results of both of these trials are expected in the middle of 2022. Finally, we anticipate the launch of a 52-week biopsy-driven Phase II NASH trial in the fourth quarter of 2022. Based on the remarkable effects of pembidutide on liver fat reduction in our first in-human clinical trial, we expect robust effects on NASH, histology, and other clinical endpoints. Turning to hep T cell, enrollment in our Phase II clinical trial in chronic hepatitis B subjects is ongoing, with study readout expected in the first half of 2023. We are excited about the progress of Pembidutide in hep T cell and the data we have generated so far. We expect 2022 to be an important year for Altimmune with three major readouts representing significant potential value drivers for the company. With that, I will now turn the call over to our Chief Medical Officer, Dr. Scott Harris, to discuss our data and clinical plan.
spk03: Scott? Thank you, Vipin, and good morning, everyone. As Vipin mentioned, we are on the verge of completing enrollment in our Phase 1B NAFLD clinical trial of penvidutide. The trial is designed to assess the effects of penvidutide on liver fat in subjects with obesity or overweight with NAFLD defined as a 10% or greater liver fat content as measured by MRI PDFF. Approximately 72 non-diabetic and diabetic subjects are being randomized one to one to one to one to penvidutide 1.2 milligrams, 1.8 milligrams, 2.4 milligrams or placebo over 12 weeks of treatment. The primary endpoint of this trial is the reduction in liver fat by MRI PDFF, but a key secondary endpoint is weight loss at the end of 12 weeks of treatment, as we believe that obesity is the key driver of NAFLD and NASH. As Vipin mentioned, we expect a data readout from this trial in the third quarter, of 2022. Based on the results of our recently completed phase one clinical trial, we expect to achieve a robust reduction in liver fat content and again show a significant weight loss in these subjects after 12 weeks of treatment. We have also initiated a 12-week extension for subjects who complete the initial 12 weeks of treatment. This will permit subjects to receive treatment for up to 24 weeks and allow us to compare the weight loss achieved by pembidutide to the weight loss achieved by semaglutide and turzepatide after 24 weeks of treatment. Next, let me talk about the Phase II Momentum Trial of pembidutide in obesity, in which we expect to commence enrollment later this month. We expect this important trial will enroll approximately 320 non-diabetic subjects with either overweight or obesity with at least one obesity-related complications. Subjects will be randomized one-to-one to one-to-one to receive either 1.2 milligrams, 1.8 milligrams, 2.4 milligrams, pendidutide, or placebo administered weekly for 48 weeks. The primary endpoint of the momentum trial is the relative or percent change in body weight at 48 weeks compared to baseline with additional readouts including metabolic and lipid profiles, cardiovascular measures, and glucose homeostasis. Dr. Lua Ran from the Weill Cornell Medical School, a leading authority in obesity and obesity clinical trials, is serving as the principal investigator. An interim analysis is planned to assess changes in body weight after 24 weeks of treatment with an expected readout in the fourth quarter of 2022 and a 48-week readout in the middle of 2023. During the fourth quarter of 2021, we also completed six-month and nine-month toxicology studies of pendidutide in rats and non-human primates. These studies showed no significant findings, including no ALT or blood glucose elevations in either species. The completed tox studies will support the upcoming 24-week NAPLD extension and 48-week obesity studies, as well as advanced development of pembidutide. Following completion of our Phase 1b trial in NAPLD, we are planning to initiate a 52-week biopsy-driven Phase 2 NASH trial in the fourth quarter of 2022. We currently expect this trial to enroll approximately 250 non-diabetic and diabetic subjects with biopsy proven NASH. The subjects are randomized one to one to one to receive one of two doses of pembidutide or placebo. The key endpoints of the trial will be NASH resolution and fibrosis improvement. Finally, by the middle of the year, we expect to have the results of two phase one trials to evaluate the effects of pentadutide on glucose control in diabetics and its potential for drug-drug interactions. We are rapidly building the pentadutide clinical development program and expect to have accrued safety data in over 200 subjects, receiving one or more doses of pentadutide in clinical trials by the fourth quarter of 2022. I want to highlight the important effects of pentadutide on serum lipids in our first in-human clinical trial, which could have important implications for cardiovascular risk. It is well established that NASH and NAFLD patients succumb most often to the cardiovascular comorbidities associated with obesity, which include myocardial infarction, stroke, and heart failure. Pentadutide treatment for 12 weeks resulted in reductions in total cholesterol, LDL cholesterol, and triglycerides that were comparable to those achieved by statins. In addition, lipidomic profiling demonstrated pronounced reduction in a wide range of inflammatory lipids, such as glycerophospholipids and sphingolipids, including ceramides, that have been implicated in the pathogenesis of NASH, atherosclerosis, and metabolic syndrome. We are also making continued progress in the enrollment of our Phase II clinical trial in patients with inactive chronic hepatitis B and are on target to read out the results of this trial in the first half of 2023. Recall that virologic effects of hep T cell are being evaluated in chronically infected patients to enable the combination of hep T cell with novel direct acting antivirals as part of combination therapy for chronic hepatitis B. We are excited about the data that we have generated and expect to generate in 2022, which we plan to present at international meetings later this year. We are pleased to announce that pentadutide abstracts have been accepted as oral presentations at the American Diabetes Association and the European Association for the Study of Liver Disease annual meetings in June of this year. We hope to announce the publication of these study results in peer-reviewed journals in the near future. I will now hand the call over to Rich Eisenstadt to give us an update on our full year and fourth quarter financial results. Rich?
spk02: Thank you, Scott. For today's call, I'll be providing a brief update on Altmead's full year and fourth quarter 2021 financial and operating results. More comprehensive information will be available in our Form 10-K to be filed with the SEC later today. Aldermen ended the fourth quarter of 2021 with approximately $190.3 million of cash, cash equivalents, and short-term investments, compared to $216 million at the end of 2020. We continue to have sufficient cash to operate through 2023, including completing our Phase II trial Pembidutide and Obesity, and our planned Phase II trial in NASH. Turning to the income statement, revenue in the fourth quarter of 2021 was $3.3 million, compared to $2.3 million in the fourth quarter of 2020. Our revenue for the quarter was primarily prior period rate adjustments received in the quarter for earlier government-funded research projects. Revenue for the full year of 2021 was $4.4 million compared to $8.2 million in 2020. The decline in revenue between the years was primarily due to the decrease in revenue attributable to the TCOVID program, which was completed earlier in 2021. Research and development expenses were $20.2 million in the fourth quarter of 2021 compared to $9 million in the fourth quarter of 2020. The increase in R&D expense was primarily the result of the increased costs related to the development of Pemfidutide and a non-cash recognition of the change in fair value of contingent consideration liability connected with the acquisition development of Pemfidutide as we near the next milestone. As a reminder, we will owe one last development milestone of $3 million payable in common shares of the company within 60 days following dosing of the first patient in a Phase II trial of Pemvidutide. Research and development expenses were $74.5 million in the full year of 2021, compared to $49.8 million in the prior year. The increase in R&D expenses is primarily the result of ad-COVID-related development costs, including the expensing of payments made to Lonza for the construction of a manufacturing suite, We terminated our agreement with Lonza at the end of 2021. The increase in R&D expense is also attributable to development activities for Pemba-Dutai. Note that as a result of terminating the Lonza agreement in connection with the discontinuation of AddCOVID, we recorded an impairment loss of $3.3 million in the fourth quarter of 2021 and $11.4 million for the full year of 2021. associated with assets previously capitalized and connects with the construction of the Lonza Manufacturing Suite. This represents the full cost of that asset that had previously been capitalized. General and administrative expenses remain generally consistent at $3.8 million in the fourth quarter of 2021, as compared to $4.1 million in the same period in 2020. For the full year 2021, general administrative expenses were $15.4 million versus $13.2 million for full year 2020. The increase was primarily due to increased stock compensation expense and additional labor-related costs in 2021 associated with a full year of staff added in 2020 to support our clinical programs. Net loss for the three months ended December 31st, 2021 was $23.9 million or 57 cents net loss per share compared to $10.6 million or 29 cents net loss per share for the fourth quarter of 2020. The difference in net loss is primarily attributable to the higher research and development expenses and lower contract revenue. Net loss for the year ended December 31st, 2021, was $97.1 million, or $2.35 net loss per share, compared to $49 million, or $1.91 net loss per share for the year ended December 31st, 2020. The increase in net loss is primarily attributable to higher research and development expenses in 2021 associated with Pemba Dutai, and are now discontinued vaccine programs and the recognition of the lawns impairment loss for COVID. I'll now turn it back over to Bipin for his closing remarks. Bipin.
spk06: Thank you, Rich. Operator, that concludes our formal remarks, and we would like to open the line to take questions. Could you please instruct the audience on the Q&A procedure?
spk09: Certainly. Ladies and gentlemen, if you have a question at this time, please press star then one on your touchtone telephone. If your question has been answered and you'd like to remove yourself from the queue, please press the pound key. Our first question comes from the line of Seamus Fernandez from Guggenheim. Your question, please.
spk04: Oh, great. Thanks for the question, guys. So just a couple of clarifications. Maybe first and foremost, it sounds like the recruitment probably was impacted by COVID to some degree. You know, so the 12-week data we'll see from the Phase 1B NAFLA study in the third quarter, can you just maybe give us a general sense of what we'll see in that data, just because I think some of the data was a little bit broken up in the Australia study for the Phase 1A. Maybe you could just give us a sense of the, you know, what we're going to see in those data and what will be incorporated into it? And then second, you did clarify that the 24-week, the extension to 24 weeks in that study has been approved and will be executed. Will all of the patients actually that were recruited in the study be incorporated into that 24-week update? And then just finally on the obesity study, can you just clarify, is it most likely that the obesity study, the interim will actually read out more likely in the first quarter of next year for investors, but perhaps you'll have or be evaluating those data internally. I just want to make sure that we get the timelines correct. Thanks.
spk06: Absolutely. Good morning, Seamus, and thank you for your questions. Scott Harris, do you want to take this?
spk03: Yeah. Hi, Seamus, and thanks for your questions. First, regarding the 12-week readout of the third quarter of 2023, we're going to focus at this time on the primary readouts, which will be liver fat reduction, weight loss, adverse events, particularly GI adverse events, and laboratory data. Those will be the focus of the readout. There may be other readouts provided as well, but I'd like us to concentrate on those. You are correct, the 12-week data, the 12-week extension to the NAFLD study was approved. This is a separate study to the parent study and the patient is not automatically enrolled but has the option of enrolling. That depends on the various factors that exist at the time that the patient rolls over. We're anticipating that most of the patients will roll over, but not all of the patients. That's simply the way it occurs in studies, and that happens for a variety of reasons. And right now we're still advising the street that our 24-week readout, meaning the announcements of the results of the interim analysis and that weight loss study in 24 weeks will still occur in 2022. Great. Thank you.
spk09: Thank you. Our next question comes in line of Yasmin Rahimi from Piper Sandler. Your question, please.
spk01: Good morning, team. I have a number of questions for you. Maybe a first place to start off is can you comment on how many patients at this junction have completed 12 weeks of treatment? I definitely appreciate you giving us guidance or insight that 90% is complete. So let's start there and then I have a bunch of other questions.
spk03: Right. Yes. Well, as we noted, we've accrued more than 90% of the qualified subjects needed to conduct the study that have been dosed or will be dosed shortly. And, you know, as mentioned previously, we'll be on track to announce the results in the third quarter. That means that all the subjects will get to the finish line in order to announce the results. I think that's more relevant than the number of patients that have completed.
spk01: Okay. Can you maybe comment on, since you're at about 90% completion rate, whether the fraction of diabetic versus non-diabetics, which you guided previously was going to be 50-50, is coming in around your expectation, or do you think that maybe the fractions are slightly modified? If you could comment on that as well, please.
spk03: Right. You know, it's always changing, but I'd say that it's meeting our expectations of approximately 50-50. Okay.
spk01: Another question I have for you in regards to the interim analysis in the diabetes study, could you maybe help us understand at the 24-week diabetes momentum study, what fraction of patients will be reported? Like is this half of the population? Is this just any color you could give us at that 24-week time point? on the size of the interim could be helpful and whether the interim could show a statistical separation in weight loss.
spk03: Right. Just to correct, I think you got a little confused on terms. It's an obesity study. It's not a diabetes study. Oh, sorry. Yes, obesity study. That's okay. My apologies. Yes. No problem. And it actually is a study of non-diabetics. At the current time on the 24-week readout that we're expecting to announce at the end of the year, we expect to report on 100% of the patients. And, you know, the current plan is to report out statistical significance at that time.
spk01: Okay.
spk06: Yeah, I mean, if I could jump in here, one thing I would like to emphasize is that these obesity studies, unlike NASH, they enroll very fast. based on all of the analysis that we've done, we're learning that there is a lot of subjects out there who like to enroll in these studies. So we're expecting to enroll the study much faster than you typically see with NASH studies. So I think that would help us as we start this obesity study here in the next few weeks.
spk01: Thank you, Tim. And then the last question. discontinuation rates, do you get notified currently in the NAFLD study if patients discontinue due to GIAEs or any other liver enzyme abnormalities? Can you comment on what you're seeing so far from the safety side of the drug? And I'm cautious of this because this is on a blinded basis. And thank you again for taking my long list of questions.
spk03: All right, yes. Well, thank you. Well, as you've acknowledged, it's a blinded study, and as you recognize, it's best for study integrity to renounce the results of any trial study on the planned date, but I can confirm that we're extremely pleased with the safety profile so far in this study.
spk01: Thank you.
spk09: Thank you. Our next question comes from the line of Roger Song from Jefferies. Your question, please.
spk07: Great. Thank you for taking our question. A couple from us. So first one is for the 24-week weight loss data from the Phase II obesity data. So what is your expectation based on Phase Ia data? And related to that is, do you expect a little bit higher baseline BMI compared to the previous phase one? Right.
spk03: Thanks for the question, Roger. I'll take the second question first. Yes, we expect that the average BMI in the obesity study will be approximately 35, heavier than in the phase one study. And, you know, right now, we're focusing on where the weight loss is going to be at the end of the year. And the trajectory of the study shows that we should be beating the weight loss achieved by semaglutide and terazepatide about one year or 48-week time point.
spk07: Got it. Okay, great. Thank you. And then for the Phase II 52-week NASH study, You say you will start in 4Q. Maybe just a two related question is one, what kind of data you expect from the Phase 1b 12-week study to trigger you to make the go-no-go decision? And I realize you have this extension 24-week data also around the same time, 4Q. So do you need to weigh that data before you start the Phase 2 52-week NASH study?
spk03: Right. Thanks, Roger. Well, the first question pertained to the kind of data that we would need from that 12-week NAFLD study. And, you know, we expect to replicate the data that we saw in our Phase I study where we saw remarkable reductions in liver fat, and that would lead us then to move ahead with the committed NASH study. In answer to the second part of your question, no, we would not wait for the 24-week data. We would make the decision on the 12-week data.
spk07: Great. Thank you for the comment. Maybe just the last one. Sorry for the long list as well. So you mentioned you already completed a six-month and a nine-month toxicology study. Just curious, any additional GLP-TOCS you need to support a potential chronic use label?
spk05: Scott Roberts, do you want to take that?
spk03: Vipin, I can answer that question. Yeah.
spk06: No, absolutely. Yeah. Go ahead, Scott.
spk03: Yeah. Yeah. Roger, the answer is no. Our toxicology program is complete. We've been given the go ahead by the FDA to conduct studies in upwards or greater than 48 to 52 weeks. And our program is complete at this point. And I would emphasize the safety that was seen in those studies with no unexpected events, no ALT elevations, no glucose deviations. It was a very clean study. And we expect that excellent toxicology safety study to extend to human studies as well.
spk07: Excellent. Thank you. That's all for now. Thank you.
spk09: Thank you. Our next question comes from the line of John Wallabin from JMP Securities. Your question, please.
spk10: Hey, thanks for the update and taking the questions. A couple from me. Just wanted to confirm whether or not you're using a short titration period to get to the 2.4 milligram dose and the NAFLD study you're running now, and then also if so, do you plan on using that as well in the obesity study you'll be starting soon?
spk03: Right, so the answer is yes, Jonathan. As you know, we are not, when emphasized, using titration at the 1.2 or 1.8 milligram doses. The safety and tolerability profile of those compounds were excellent in the phase one study without titration. At the 2.4 milligram dose, we did see some GI adverse events, and they occurred typical for GLP-1s in the first two weeks. So consequently, we saw the rationale here of titrating in order to affect better tolerability, adjusted the 2.4 milligram dose. And we thought that it was worthwhile to pursue the 2.4 milligram doses at this time because of the potential that we could be leaving efficacy on the table by moving from that dose based on the number of patients that we dosed in the phase one study. If we do not see better results at the 2.4 that we saw at the 1.8, the likelihood is that we would not pursue that dose going forward. But at the current time, we are planning to carry the 2.4 dose into both the NAFLD study, the 12-week NAFLD study, and the 48-week obesity study.
spk10: Got it. And then maybe taking a step back, I know we didn't see any hyperglycemia in the Phase 1A study. I'm wondering, you know, what are your thoughts mechanistically on why we aren't or why we won't? Or is this something you think may pop up with longer dosing and more patients?
spk03: Yeah, we don't think it's going to appear, Jonathan. You know, I'll go back to the preclinical studies we did in diabetic mice. The glucose control that was actually achieved in that study was actually better than semaglutide. We think in humans that at a minimum, glucose control be maintained because of the balance which is one-to-one between the GLP-1 agonism and the glucagon agonism, and they'll balance each other out in glucose control. As we saw in the phase one study, we had no perturbations of fasting blood sugar, and we had no perturbations of hemoglobin A1C, and we think that's going to continue as well, not only in non-diabetics, but diabetics as well. And as we reported previously, because of the weight loss that was induced in these patients, we actually saw a decrease in insulin resistance, which means that during the course of a trial with weight loss, blood sugars are gonna decrease over time, especially in diabetics. So to summarize, we're very bullish on the ability of this drug to maintain glucose control. We are, as Vipin mentioned, doing a committed study in diabetics, and we'll have those results in the middle of the year, but we think the results will continue to demonstrate the control of blood sugar that we saw in the non-diabetics.
spk10: Certainly been impressive so far, and I'm looking forward to all the data this year. Thanks for taking the questions.
spk09: Thank you. Our next question comes from the line, Mayim Tini from B. Reilly Securities. Your question, please.
spk08: Good morning, team. Thanks for taking our questions, and welcome, Rich, to these calls. So maybe just to clarify on previously asked questions, first on the six- and nine-month toxicology study, can you remind us the highest dose you've gone in those non-human primates and rodents, and what's the safety margin you're working with? And then on the DDI study, Just curious what background therapies have been with that. Any chance you have, you know, GLP-1 combination with that? And the reason I ask is, as you know, Novo Nordisk is looking to combine, you know, their next generation molecules with GLP-1. So I'm just curious if, from a safety package standpoint, what sort of information you're kind of putting together from the preclinical and the DDI studies?
spk03: Thanks, Mayank. I'm going to answer the toxicology questions, but your voice is a bit muted, and I'm not sure I understood the second question about combining with GLP-1. So when we get to that, I'm going to ask you to repeat that. I don't have the highest doses of the GLP-1 of the toxicology studies in front of me. I will tell you that there is a more than adequate safety margin between the toxokinetic levels or the serum levels at the toxicologic doses of drug and the human doses. That margin was more than adequate. But could you repeat the second question please?
spk08: Yeah, sorry about that. I hope you can hear me fine now. So the question was on the DDI study. What background therapies are you looking at and any chance You're looking at also a GLP-1 sort of combination where, and the reason I ask is, Novo Nordisk, as you may have seen at NASHTAG, presented some data on combining one of their next generation of myelin analog with a GLP-1. So I'm just curious, what sort of background therapies are you looking at as part of the DDI? And if you have any plans to head-to-head study longer term against, you know, terzobitavide or semaglutide?
spk03: Right. So the first part of the question, regarding the DDI studies, it's pretty much a checkbox exercise, which is expected by FDA to be working in this class. And it's not actually at the level of cytokines, Mayak, because these are peptides that are not expected to have cytokine or transporter interactions. But it's actually the hypothetical, and I emphasize that term, effects of GLP-1s on gastric emptying and then for the absorption of drugs. And pretty much the same substrates are used in all of these studies representing different solubility and absorptibility classes of drugs. And that's what we're putting into the trial. But I want to emphasize that none of the long-acting GLP-1s have had any effects on gastric emptying or on drug interactions. And we would be extremely surprised if we saw that effect. And we're not doing this study because of any concern. We're doing it out of what we perceive to be a regulatory obligation. Regarding the second part of your question, you know, it's pretty clear that you can only get to about 15% weight loss with GLP-1 monotherapy. And in order to achieve the levels of weight loss that are seen with bariatric surgery, GLP-1 has to be combined with another drug. That's been the emphasis. And I would emphasize in that regard that we have combination therapy because we're adding glucagon to GLP-1 and we think that that's the optimal combination. agonist or candidate or other molecule or compound to add to the GLP-1 because of the synergy of GLP-1 and glucagon with GLP-1 reducing appetite, but glucagon driving energy expenditure. If you look at drugs such as the amylin compound that Novo has or the addition of GIP, which is terazepatite, they mainly work by suppressing appetite. So we have a much greater opportunity to affect weight loss and other metabolic improvements by making that combination with GLP-1 and glucagon. I believe there might have been a third part of the question, and I'm not sure I hit it. Mayank, if you want to ask it, I'm happy to answer it.
spk09: Mayank, you might be on mute.
spk08: I apologize, and thank you for that detailed color. The third part of the question was on any longer-term plans to generate head-to-head data versus terzapatide or semaglutide, and if you think you would need that, you know, from a regulatory or commercial standpoint.
spk03: Yeah, we don't think at this time that that will be needed. It certainly, it's not in our current plans right now. We could discuss that in the future.
spk08: Got it. And final question on the NAFAA, just quickly, how many subjects have currently rolled over in case you have that information? And then I know you commented on the relative difference in the inclusion criteria for Phase 1 and then Phase 1B on MRI, PDFS, and weight levels. Can you also comment on age group? Like what's, if any, differences on, you know, what sort of age groups and maybe, you know, sex of these patients that could be helpful to know for the investors? Yeah.
spk03: Regarding the rollover, I'd rather focus on where we're going to be, which is going to be on a readout on the 24-week data from the extension in the fourth quarter. The age, I believe, is coming in where we expected, which is typically in the mid-40s for a trial like this. but I don't have that information directly in front of me right now.
spk08: Okay. Thanks for taking our questions.
spk09: Thank you. Our next question comes from the line of Patrick Trucchio from HC Wainwright. Your question, please.
spk11: Thanks. Good morning, everyone. Just a quick follow-up on the interim analysis and the momentum program. I'm wondering if you can discuss the expectations in terms of the side effects and tolerability, and particularly around the GI side effects and the potential discontinuation rate in the program that you could see at that time. And then secondly, just with the key Phase II readouts expected this year on Pembedootide, I'm wondering what your latest thoughts are on timing a potential partnering of the program for Phase III, or if you could potentially bring this program forward in national obesity on your own.
spk03: Thanks, Patrick. I'll answer the first question, and then I'll turn to Vipin to answer the second question. We're very confident about the side effect profile that we have with our drug. As we've emphasized before, the most meaningful declaration of tolerability is whether the patient discontinues treatment. And that's the one metric that can be compared across all studies because otherwise it's called patient reported outcomes. which are very highly dependent on conditions, investigators, the patients, and a number of other things. So focusing on the discontinuation rates, as you've mentioned, we didn't have any discontinuation rates for adverse events in our phase one study. As I noted, we're trying to focus our data communications on the planned readout dates, and I don't want to get into discontinuation rates that may be occurring during the trial right now, but I would say and emphasize that we're extremely pleased with the safety profile of the compound that we've seen so far in the clinical trial. And with that, I'll turn the second question over to Vipin.
spk06: Yeah, thanks, Patrick. Look, as we have said all along, our goal is to continue to generate a very compelling data package, and that's exactly what we are doing. It's very hard to tell you exactly what the timing of a potential strategic transaction might be, but we think as we progress into 2022, we've got a lot of studies that we'll be reading out. All of those will increase the value of the assets, We think it's a very compelling asset that a number of companies out there would want to partner with us or would want to evaluate the asset and do some sort of strategic transaction. So we'll keep everybody posted on that, but we need to focus on generating this data and really increase the value of the asset as we go into 2023.
spk11: That's helpful. Thank you very much.
spk09: Thank you. This does conclude the question and answer session of today's program. I'd like to hand the program back to Vipin for any further remarks.
spk06: Thank you, everyone, for participating today. We appreciate this opportunity to share our results and outlook with you, and thank you for your continued interest. Have a wonderful day.
spk09: Thank you, ladies and gentlemen, for your participation at today's conference. This does conclude the program. You may now disconnect. Good day.
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