ALTIMMUNE INC (ALT) Q4 2021 Earnings Call Transcript

ALTIMMUNE INC (ALT -3.23%)
Q4 2021 Earnings Call
Mar 15, 2022, 8:30 a.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Good day, ladies and gentlemen, and welcome to the Altimmune Inc. full year and Q4 earnings conference call. [Operator instructions] As a reminder, this call is being recorded. I would now like to introduce your host for today's conference, Rich Eisenstadt, chief financial officer at Altimmune.

Rich, you may begin.

Rich Eisenstadt -- Chief Financial Officer

Thank you, Jonathan, and good morning, everyone. Thank you for participating in Altimmune's full year and fourth quarter 2021 earnings conference call. Members of the Altimmune team joining me on the call today are Vipin Garg, our chief executive officer; Scot 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. Altimmune 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 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 in 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 Altimmune's website. With that, I will now turn the call over to Dr.

Vipin Garg, chief executive officer of Altimmune.

Vipin Garg -- Chief Executive Officer

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 1 data set in the development of our lead product candidate pemvidutide. We announced positive data from a 12-week Phase 1 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 pemvidutide in subjects with nonalcoholic fatty liver disease, or NAFLD. That trial is ongoing at multiple sites in the United States with Dr.

Stephen 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 the 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 tirzepatide at the six-month time point.

We expect to report this important readout in the fourth quarter of 2022. Early this year, we received IND clearance from the FDA to evaluate pemvidutide for obesity, and we are preparing to commence enrollment in the 48-week Phase 2 Momentum trial of pemvidutide in obesities 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 20 weeks of treatment -- sorry, 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 pemvidutide in 2022. Looking to other studies in 2022. We recently initiated a 12-week trial to characterize effects of pemvidutide on glucose control in subjects with type 2 diabetes as a follow-on to our recently completed first-in-human Phase 1 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 1 drug-drug interaction trial to evaluate any potential interactions of pemvidutide 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 2 NASH trial in the fourth quarter of 2022. Based on the remarkable effects of pemvidutide on liver fat reduction in our first-in-human clinical trial, we expect robust effects on NASH, histology and other clinical endpoints. Turning to HepTcell.

Enrollment in our Phase 2 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 pemvidutide in HepTcell 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. Scott?

Scott Harris -- Chief Medical Officer

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 pemvidutide. The trial is designed to assess the effects of pemvidutide 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 nondiabetic and diabetic subjects are being randomized one to one to one to one to pemvidutide 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 the data readout from this trial in the third quarter of 2022. Based on the results of our recently completed Phase 1 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 pemvidutide to the weight loss achieved by semaglutide and tirzepatide after 24 weeks of treatment. Next, let me talk about the Phase 2 Momentum trial of pemvidutide in obesity in which we expect to commence enrollment later this month. We expect this important trial will enroll approximately 320 nondiabetic 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 pemvidutide 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. Lou Aronne 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 pemvidutide in rats and nonhuman 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 NAFLD extension and 48-week obesity studies as well as advanced development of pemvidutide. Following completion of our Phase 1b trial in NAFLD, 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 nondiabetic and diabetic subjects with biopsy-proven NASH, the subjects randomized one to one to one to receive one of two doses of pemvidutide 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 1 trials to evaluate the effects of pemvidutide on glucose control and diabetics and its potential for drug-drug interactions. We are rapidly building the pemvidutide clinical development program and expect to have accrued safety data in over 200 subjects receiving one or more doses of pemvidutide in clinical trials by the fourth quarter of 2022.

I want to highlight the important effects of pemvidutide 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 come most often to the cardiovascular comorbidities associated with obesity, which include myocardial infarction, stroke, and heart failure. Pemvidutide 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 glycerol phospholipids and single lipids, 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 2 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 HepTcell are being evaluated in chronically infected patients to enable the combination of HepTcell with novel direct-acting antivirals as part of combination therapy for chronic hepatitis B. We are excited about the data that we have regenerated and expect to generate in 2022, which we plan to present at international meetings later this year. We are pleased to announce that pemvidutide abstracts have been accepted as oral presentations at the American Diabetes Association and European Association for the Study of Liver Disease annual meetings in June of this year.

We hope to announce the publication of the 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?

Rich Eisenstadt -- Chief Financial Officer

Thank you, Scott. For today's call, I'll be providing a brief update on Altimmune'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. Altimmune 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 2 trial pemvidutide in obesity and our planned Phase 2 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 T-COVID 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 pemvidutide and a noncash recognition of the change in fair value of contingent consideration liability connected with the acquisition development of pemvidutide 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 2 trial pemvidutide. Research and development expenses were $74.5 million in full year 2021 compared to $49.8 million in the prior year. The increase in R&D expense was primarily the result of AdCOVID-related development costs, including the expensing of payments made to Lonza for the construction of 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 pemvidutide. Note that as a result of terminating the Lonza agreement in connection with the discontinuation of AdCOVID, 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 in connection 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 and 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 the full year of staff added in 2020 to support our clinical programs. Net loss for the three months ended December 31, 2021, was $23.9 million or $0.57 net loss per share, compared to $10.6 million or $0.29 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 31, 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 31, 2020. The increase in net loss is primarily attributable to higher research and development expenses in 2021 associated with pemvidutide and our now discontinued vaccine programs and the recognition of the Lonza impairment loss for AdCOVID. I'll now turn it back over to Vipin for his closing remarks. Vipin?

Vipin Garg -- Chief Executive Officer

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?

Questions & Answers:

Operator

Certainly. [Operator instructions] Our first question comes from the line of Seamus Fernandez from Guggenheim. Your question, please.

Seamus Fernandez -- Guggenheim Partners -- Analyst

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.

So the 12-week data we'll see from the Phase 1b NAFLD 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. So maybe you could just give us a sense of the -- 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 weeks -- the extension to 24 weeks in the NASH 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 time lines correct.

Vipin Garg -- Chief Executive Officer

Absolutely. Seamus, thank you for your questions. Scott Harris, do you want to take these?

Scott Harris -- Chief Medical Officer

Yes, Seamus. Thanks for your questions. First, regarding the 12-week readout in the third quarter of 2023, we're going to focus at this time in 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 extensions in 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 all 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 in that weight loss study in 24 weeks, will still occur in 2022.

Seamus Fernandez -- Guggenheim Partners -- Analyst

Great. Thank you.

Operator

Our next question comes from the line of Yasmeen Rahimi from Piper Sandler. Your question, please.

Yasmeen Rahimi -- Piper Sandler -- Analyst

Good morning, team. I have a number of questions for you. Maybe first place to start off, 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.

Scott Harris -- Chief Medical Officer

Right, Yas. 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 as mentioned previously, we'll be on track to announce the results in the third quarter. That means that all of 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.

Yasmeen Rahimi -- Piper Sandler -- Analyst

OK. Can you maybe comment on -- since you're at about 90% completion rate, whether the fraction of diabetic versus nondiabetic you guided previously was going to be 50-50. It's 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.

Scott Harris -- Chief Medical Officer

Right. It's always changing, but I'd say that it's meeting our expectations of approximately 50-50.

Yasmeen Rahimi -- Piper Sandler -- Analyst

OK. 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 can 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 and weight loss.

Scott Harris -- Chief Medical Officer

Right. Just to correct, I think you got a little confused on terms. It's an obesity study, it's not a diabetes study.

Yasmeen Rahimi -- Piper Sandler -- Analyst

Yes, obesity study, yes. My apologies, yes.

Scott Harris -- Chief Medical Officer

That's OK. No problem. And it actually is a study of nondiabetics. 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 the current plan is to report out statistical significance at that time.

Vipin Garg -- Chief Executive Officer

Yes. Yasmeen, if I could jump in here, one thing I would like to emphasize 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.

Yasmeen Rahimi -- Piper Sandler -- Analyst

And last question. Discontinuation rates, do you get notified currently in the NAFLD study of patients discontinued due to GI, AEs 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.

Scott Harris -- Chief Medical Officer

All right, Yas. Well, as you've acknowledged, it's a blinded study. And as you recognize it's best for study integrity to announce 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.

Yasmeen Rahimi -- Piper Sandler -- Analyst

Thank you.

Operator

Our next question comes from the line of Roger Song from Jefferies. Your question, please.

Roger Song -- Jefferies -- Analyst

Great. Thank you for taking our question. A couple from us. So first one is for the 24-week weight loss data from a Phase 2 obesity data.

So what is your expectation based on Phase 2 data? And related to that is, do you expect a little bit higher baseline BMI compared to the previous Phase 1?

Scott Harris -- Chief Medical Officer

Right. 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 1 study.

And 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 tirzepatide about one year or a 48-week time point.

Roger Song -- Jefferies -- Analyst

Got it. OK. Great. And then for the Phase 2 52-week NASH study, you say you will start in 4Q.

Maybe just a – two related questions, one, what kind of data you expect from the Phase 1b 12-week study to trigger in -- 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?

Scott Harris -- Chief Medical Officer

Right. Thanks, Roger. Well, the first question pertains to the kind of data that we would need from that 12-week NAFLD study. And we expect to replicate the data that we saw in our Phase 1 study, where we saw remarkable reductions in liver fat, and that would lead us then to move ahead with the committed NASH study.

And to answer 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.

Roger Song -- Jefferies -- Analyst

Maybe just last one, sorry for the long list as well. So you mentioned you already completed six months and the nine-month toxicology study. Just curious any additional GLP talks you need to support a potential chronic use label?

Vipin Garg -- Chief Executive Officer

Scot Roberts, do you want to take that?

Scott Harris -- Chief Medical Officer

Vipin, I can answer that question as Scot --

Vipin Garg -- Chief Executive Officer

No, absolutely. Yes. Go ahead, Scott.

Scott Harris -- Chief Medical Officer

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 GL -- 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.

Roger Song -- Jefferies -- Analyst

Excellent. Thank you. That's all I had.

Operator

Our next question comes from the line of Jon Wolleben from JMP Securities. Your question, please.

Jon Wolleben -- JMP Securities -- Analyst

Hey. Thanks for the update and taking the question. A couple for 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 running down.

And then also do you -- if so, do you plan on using that as well in the obesity study that will be starting soon?

Scott Harris -- Chief Medical Officer

Right. So the answer is yes, Jonathan. As you know, we are not, when emphasize, using titration at the 1.2 or 1.8 milligram doses. The safety and tolerability profile of those compounds were excellent in the Phase 1 study without titration.

The 2.4 milligram dose, we did see some GI adverse events, and they occurred typical for GLP-1s in the first 2 weeks. So consequently, we saw the rationale here of titrating in order to affect better tolerability at just at 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 1 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.

Jon Wolleben -- JMP Securities -- Analyst

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 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?

Scott Harris -- Chief Medical Officer

Yes. We don't think it's going to appear, Jonathan. I'll go back to the preclinical studies we did in diabetic mice. The glucose control that was actually achieved from that study was actually better than semaglutide.

We think in humans that, at a minimum, glucose control will 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 1 study, we had no perturbations of fasting blood sugar. We had no perturbations of hemoglobin A1c. And we think that's going to continue as well, not only in nondiabetics, 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 the trial with weight loss, blood sugars are going to 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 nondiabetics.

Jon Wolleben -- JMP Securities -- Analyst

Certainly, been impressive so far, and I'm looking forward to all the data this year. Thanks for taking the questions.

Operator

Our next question comes from the line of Mayank Mamtani from B. Riley Securities. Your question, please.

Mayank Mamtani -- B. Riley Financial, Inc. -- Analyst

Good morning, and thanks for taking our questions. And welcome, Rich, to this call. 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 nonhuman 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 GLP-1 combination with that? And the reason I ask is, as you know, Novo Nordisk is looking to combine their next-generation molecules with GLP-1.

And 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 study in the first half.

Scott Harris -- Chief Medical Officer

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 GLP-1 of the toxicology studies in front of me. I will tell you that there was a more than adequate safety margin between the tox or kinetic levels with the serum levels at the toxicologic doses of drug in the human dose is. That margin was more than adequate. But could you repeat the second question, please?

Mayank Mamtani -- B. Riley Financial, Inc. -- Analyst

Yes. 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 NASH-TAG, presented some data on combining their next -- one of the next generation of amylin with the 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 do head-to-head study longer term against tirzepatide or semaglutide.

Scott Harris -- Chief Medical Officer

Right. So the first part of the question regarding the DDI studies, it's pretty much a check box exercise, which is expected by FDA to be working in this class. And it's not actually at the level of cytokines, Mayank, because these are peptides and not expected to have cytokine or transported interactions. But it's actually the hypothetical, and I emphasize that term, effects of GLP-1s in 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 absorptivity 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 a that any effects on gastric emptying or on drug interactions, and we have been extremely surprised if we saw that effect. And we're not doing the 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, 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 agonist or candidate for other molecules or compounds to add to the GLP-1 because of the synergy of GLP-1 and glucagon with GLP-1 reducing appetite with glucagon driving energy expenditure. If you look at drugs such as the amylin compound that Novo has or the addition of GIP, which is tirzepatide, 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 glucagon.

I believe there might have been a third part of the question but I'm not sure I hit it. Mayank, if you want to ask, I'm happy to answer it.

Mayank Mamtani -- B. Riley Financial, Inc. -- Analyst

Thank you for that detailed color. Yes, the third part of the question was any longer-term plans to generate head-to-head data versus tirzepatide or semaglutide? And if you think you would need that from a regulatory or commercial standpoint?

Scott Harris -- Chief Medical Officer

Yes. 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.

Mayank Mamtani -- B. Riley Financial, Inc. -- Analyst

Got it. And final question on the NAFLD 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-PDFF and weight levels. Can you also comment on age group? Like what's -- if any, differences on what sort of age groups and maybe sex of these patients that could be helpful to know for the investor.

Scott Harris -- Chief Medical Officer

Yes. 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.

Mayank Mamtani -- B. Riley Financial, Inc. -- Analyst

OK. Thanks for taking our questions.

Operator

Our next question comes from the line of Patrick Trucchio from H.C. Wainright. Your question, please.

Patrick Trucchio -- H.C. Wainwright and Company -- Analyst

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 2 readouts expected this year on pemvidutide, I'm wondering what your latest thoughts are on timing of potential partnering of the program for Phase 3? Or if you could potentially bring this program forward in NASH and BC on your own?

Scott Harris -- Chief Medical Officer

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 what's called patient-reported outcomes, which are very highly dependent on conditions, investigators and 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 1 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 were -- 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.

Vipin Garg -- Chief Executive Officer

Yes. 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 asset. 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 transactions. 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.

Patrick Trucchio -- H.C. Wainwright and Company -- Analyst

Yeah. That's helpful. Thank you very much.

Operator

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.

Vipin Garg -- Chief Executive Officer

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.

Operator

[Operator signoff]

Duration: 47 minutes

Call participants:

Rich Eisenstadt -- Chief Financial Officer

Vipin Garg -- Chief Executive Officer

Scott Harris -- Chief Medical Officer

Seamus Fernandez -- Guggenheim Partners -- Analyst

Yasmeen Rahimi -- Piper Sandler -- Analyst

Roger Song -- Jefferies -- Analyst

Jon Wolleben -- JMP Securities -- Analyst

Mayank Mamtani -- B. Riley Financial, Inc. -- Analyst

Patrick Trucchio -- H.C. Wainwright and Company -- Analyst

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