Q1 2022 Altimmune Inc Earnings Call

[music].

Operator: Good day, ladies and gentlemen, and welcome to the Altimmune, Inc. Q1 Earnings Conference Call. At this time, all participants are in a listen-only mode.

Good day, ladies and gentlemen, and welcome to the all T-man, Inc. Q1 earnings Conference call. At this time, all participants are in a listen only mode.

Operator: 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 zero on your touchtone phone. As a reminder, this call is being recorded. I would now like to introduce your host for today's conference call, Rich Eisenstadt, the financial officer of Altium, Rich Smith, again. Thank you, Katie, and good morning, everyone.

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 zero on your Touchtone phone.

As a reminder, this call is being recorded.

I'd now like to introduce your host for today's conference call Rich Eisenstadt.

The officer football team in Michigan.

You may begin.

Thank you Kate and good morning, everyone.

Rich Eisenstadt: Thank you for participating in Altimmune's first quarter 2022 earnings conference call. Members of the Altimmune team joining me on the call today are Vipin Garg, our Chief Executive Officer, Scott Roberts, our Chief Scientific Officer, and Scott Harris, our Chief Medical Officer, fund the prepared remarks, we will hold a question and answer session. Press release with our first quarter 2022 financial results was issued this morning and can be found on the investor relations section of the company's website.

You for participating in <unk> first quarter 2022 earnings conference call.

Members of the ultimate team joining me on the call today are <unk>, 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 first quarter 2022 financial results was issued this morning and can be found on the Investor Relations section of the company's website.

Rich Eisenstadt: 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 the ongoing conflict in Ukraine, COVID-19, and the 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.

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.

<unk> 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.

Weighted to the ongoing conflict in Ukraine, COVID-19, and the 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.

Rich Eisenstadt: I'd also direct you to read the forelooking 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, Thursday, May 12, 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 Altimune's website. With that, I will now turn the call over to Dr. Vipin Garg, Chief Executive Officer of Altimune. Thank you, Rich, and good morning, everyone.

I'd 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 Thursday May 12, 2022, and the company does not undertake any obligation to update any of these forward looking statements to reflect events or circumstances.

Occur on or after today's date.

As a reminder, this conference call is being recorded and will be available for audio replay on <unk> website.

With that I will now turn the call over to Dr. <unk> <unk>, Chief Executive officer of afternoon.

Thank you rich and good morning, everyone.

Vipin Garg: We appreciate you joining us today for a discussion of our first quarter 2022 financial results and business update. We continue to advance multiple clinical trials for our lead product candidate, Pembidutide, a GLP-1 glucagon dual receptor agonist, and are excited about reporting important data from these trials in the second half of 2022. Last month, we announced the initiation of the 48-week Phase 2 Momentum Trial of Pambidu Tide in subjects with obesity or who were overweight. That trial is ongoing at multiple sites in the United States with Dr. Lou Oroni.

We appreciate you joining us today for a discussion of our first quarter 2022 financial results and business update.

We continue to advance multiple clinical trials for our lead product candidate <unk> died a DLP one glucagon dual receptor agonist and are excited about reporting important data from these trials in the second half of 2022.

Last month, we announced the initiation of the 48 week phase III momentum trial of <unk> died in subjects with obesity or who were overweight.

That trial is ongoing at multiple sites in the United States with Dr. Lu our oney.

Vipin Garg: Professor of Clinical Medicine at Weill Cornell Medical College and a leading authority in obesity and obesity clinical trials, serving as the principal investigator. Dosing has commenced. And a planned interim analysis to assess changes in body weight after 24 weeks of treatment is expected to read out in the fourth quarter of 2022. Enrollment in the Phase 1b non-alcoholic fatty liver disease or NAFLD trial has been completed and data readouts for weight loss and liver fat reduction at 12 weeks of treatment are expected in the third quarter of 2022. In addition, a double-blind placebo control.

Professor of clinical medicine at Weill, Cornell Medical College, and a leading authority in obesity and obesity clinical trials.

Serving as the principal investigator.

Dosing has commenced and the planned interim analysis to assess changes in body weight. After 24 weeks of treatment is expected to readout in the fourth quarter of 2022.

Enrollment in the phase one b non alcoholic fatty liver disease or national deep trial has been completed and data and data readouts for weight loss and liver fat reduction at 12 weeks of treatment.

<unk> in the third quarter of 2022.

In addition, a double blind placebo controlled 12 week extension of the Nashville Deep trial has been initiated.

Vipin Garg: 12-week extension of the NAFLD trial has been initiated, with an expected data readout on weight loss at 24 weeks in the fourth quarter of 2022. We believe that the 24-week weight loss readout from the NAFLD Extension Trial will provide a valuable read-through to the Phase II Momentum Obesity Trial. A 12-week trial to characterize the effects of Pemvidutide on glucose control in diabetic subjects with overweight and obesity is also ongoing. This trial will further expand on the findings from our Phase I trial in which decreased insulin resistance and maintenance of glucose control were observed in an obese and overweight patient population that included subjects with prediabetes. Given the increasing competitive obesity space, it is important to highlight the potential differentiating features of Pembedutide.

With an expected data readout on weight loss at 24 weeks in the fourth quarter of 2022.

We believe that the 24 week weight loss readout from the <unk> extension trial will provide a valuable read through to the phase III momentum obesity trial.

Yes.

A 12 week trial to characterize effects of Penn, we do tied on glucose control in diabetic subjects with overweight and obesity is also ongoing.

This trial will further expand on the findings from our phase one trial in which decreased insulin resistance and maintenance of glucose control were observed in an obese and overweight patient population that included subjects with pre diabetes.

Given the increasing competitive obesity space. It is important to highlight the potential differentiating features of <unk> died.

First we believe we'll be able to achieve weight loss comparable to the results of pediatric surgery.

Vipin Garg: We believe we'll be able to achieve weight loss comparable to the results of periatric surgery, confirming the benefit of adding glucagon agonism to GLP-1 monotherapy, based on more than 10% weight loss after only 12 weeks. We expect the level of weight loss to be greater and more rapid than other agents in development. Increasing Patient Satisfaction with Treatment.

Confirming the benefit of adding glucagon agonism.

<unk> monotherapy.

Based on more than 10% weight loss after only 12 weeks.

We expect the level of weight loss to be greater.

More rapid than other agents in development, increasing patient satisfaction with treatment.

Vipin Garg: In addition, we believe that the absence of dose titration will represent a major advantage in the minds of prescribers, simplifying patient management in the first months of therapy, and finally. We believe that the robust reduction of serum lipids observed in our phase one study could translate into cardiovascular benefit with long-term use, further increasing the value proposition of PAMI-DUTAI treatment. I want to emphasize that our focus continues to be on obesity as the lead indication for PEMV2 type.

In addition, we believe that the absence of dose titration will represent a major advantage in the mindset of prescribers simplifying patient management in the first months of therapy.

And finally.

We believe that the robust reduction of serum lipid <unk> observed in our phase one study could translate into cardiovascular benefit with long term use further increasing the value proposition of family do type treatment.

I want to emphasize that our focus continues to be on obesity as the lead indication for Pam we do diet.

Vipin Garg: While we believe that our ongoing NAFLD trial will deliver the best liver fat reduction data in clinical trials to date, and adds significant value to Pembidutide. We are not planning to initiate a 52-week biopsy-driven NAST trial at the current time. We believe this decision will create additional flexibility in the development of obesity indication without forfeiting the value of panvidutide in the NASH indication, and puts us in a good position to evaluate various strategic options for the continued development of PEMI-DUTA. The findings of our preclinical studies in the Gubra mouse model were published last month.

While we believe that our ongoing Nashville deep trial.

We will deliver the best liver fat reduction data and clinical trials to date and add significant value to <unk> due date.

We are not planning to initiate a 52 week biopsy proven Nash trial at the current time.

We believe this decision will create additional flexibility in the development of obesity indication.

Without for fitting the value of when we do died in the Nash indication.

It puts us in a good position.

Evaluate various strategic options for the continued development of family due date.

The findings of our preclinical studies in the <unk> Mouse model were published last month.

Vipin Garg: And we are excited about the clinical data that we have generated, which we plan to present at international meetings throughout this year. We are pleased to announce that PEMBEDUTA abstracts have been accepted as oral presentations, at the 5th Global MASH Congress, the 82nd Annual Meeting of American Diabetes Association, and the 2022 meeting of European Association for the Study of the Liver. We hope to announce the publication of these study results in peer-reviewed journals in the near future, turning to hep T cell.

And we are excited about the clinical data that we have generated which we plan to present at international meetings without throughout this year.

We are pleased to announce that when we do died abstracts have been accepted as oral presentations.

At the fifth Global Nash Congress.

The 80, <unk> annual meeting of American Diabetes Association.

The 2022 meeting of European Association for the study of the liver.

We hope to announce the publication of these study results in peer reviewed general journals in the near future.

Turning to have T cells.

Vipin Garg: Enrollment in our Phase II clinical trial in chronic hepatitis B subjects is ongoing, with an expected study readout in the first half of 2023. We're excited about the progress of panbidutide and hep T cell and the results of ongoing trials. We expect 2022 to be an important year for Altimmune, with three major readouts representing potential significant value drivers for the company. With that, I'll now turn the call over to our Chief Medical Officer, Dr. Scott Harris, to discuss our data and clinical plans. Scott?

Enrollment in our phase II clinical trial in chronic hepatitis b subjects is ongoing.

With an expected study readout in the first half of 2023.

We are excited about the progress up when we do tie them have T cell and the results of ongoing trials.

We expect 2022 to be an important year for <unk>.

With three major readouts, representing potential significant value drivers for the company.

With that I'll now turn the call over to our Chief Medical Officer, Dr. Scott <unk> to discuss our data and clinical plans and Scott. Thank you Vipin and good morning, everyone.

Scott Harris: Thank you, Vipin, and good morning, everyone. Let me talk about the Phase 2 Momentum Trial of Pemvidutide in Obesity. We expect this trial will enroll approximately 320 non-diabetic subjects with either obesity or overweight with at least one obesity-related complication. Subjects will be randomized one-to-one-to-one-to-one to receive either 1.2 mg, 1.8 mg, 2.4 mg penvadutide or placebo administered weekly for 48 weeks.

Scott Harris: The primary endpoint of the MOMENTUM trial is the relative 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 Aroni from Weill Cornell Medical College, 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.

<unk>.

Let me talk about the phase III momentum trial of <unk> in obesity.

We expect this trial will enroll approximately 320, non diabetic subjects with either obesity or overweight with at least one obesity related complications.

Subjects will be randomized one to one to one to one to receive either one two milligrams. One eight milligrams two four milligrams kind of a <unk> or placebo administered weekly for 48 weeks.

The primary endpoint of the momentum trial is the relative percent change in body weight at 48 weeks compared to baseline with additional readouts, including metabolic and liver lipid profiles cardiovascular measures in glucose homeostasis.

Dr. <unk> from Wild Cornell Medical College, 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.

Scott Harris: As Vipin mentioned, we completed enrollment in our Phase 1B-NAFLD clinical trial of Pembidutide and expect a data readout in the third quarter of 2022. This trial is designed to assess the effects of pemvidutide on liver fat and body weight in subjects with obesity or overweight with NAFLD, defined as a 10% or greater liver fat content as measured by MRI-PDFF. Non-diabetic and diabetic subjects were randomized 1 to 1 to 1 to 1 to Penfidutide 1.2 mg, 1.8 mg, 2.4 mg or placebo over 12 weeks of treatment.

As Vipin mentioned, we completed enrollment in our phase one being novel clinical trial with <unk> <unk> and.

And expect a data readout in the third quarter of 2022.

This trial is designed to assess the effects of <unk> on liver fat and body weight in subjects with obesity or overweight with novel D defined that's a 10% or greater liver content liver fat content as measured by MRI PDF.

Non diabetic in diabetic subjects were randomized one to one to one to one dependent do Todd one two grams, one eight milligrams, two four milligrams or placebo over 12 weeks of treatment.

Scott Harris: 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 NAPLD and NASH. Based on the results of our phase one clinical trial, we expect to achieve a robust reduction in liver fat content and again show a significant weight loss in subjects after 12 weeks of treatment.

The primary endpoint of this trial is the reduction in liver fat by MRI <unk>.

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 novelty and Nash.

Based on the results of our phase one clinical trial, we expect to achieve a robust reduction in liver fat content and again show a significant weight loss and subjects after 12 weeks of treatment.

Scott Harris: 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 Pembedutide to the weight loss achieved by Semaglutide and Terzapatide at 24 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, who received treatment for up to 24 weeks and allow us to compare the weight loss achieved by <unk>.

The weight loss achieved by some are glued tied in tours appetite at 24 weeks of treatment.

Scott Harris: We expect data readout on the 24-week weight loss endpoint in the fourth quarter of 2022. Later this year, we also expect to have the results of two additional Phase I studies to evaluate the effects of PEMDU-Tide on glucose control in people with diabetes and its potential for drug-drug interaction. We are rapidly building the Pemphidutide Clinical Development Program and expect to have accrued safety data in over 200 subjects receiving one or more doses of Pemphidutide in clinical trials by the fourth quarter of 2022.

We expect data readout on the 24 week weight loss endpoint in the fourth quarter of 2022.

Later this year. We also expect to have the results of two additional phase one studies to evaluate the effects of <unk> on glucose control in people with diabetes and its potential for drug drug interactions.

We are rapidly building the <unk> clinical development program and expect to have accrued safety data and over 200 subjects, receiving one or more doses of <unk> in clinical trials by the fourth quarter of 2022.

Scott Harris: I want to highlight the robust effects of penta-dutide on serum lipids that was demonstrated in our first in-human clinical trial, which could have important implications for cardiovascular risk. It's well established that NASH and NAPLA-D patients come most often to the cardiovascular comorbidities associated with obesity, which include myocardial infarction, stroke, and heart failure. Panfidutide treatment for 12 weeks resulted in robust reductions of total cholesterol, LDL cholesterol, and triglyceride, elevated levels of which are associated with increased risk for cardiovascular disease.

I want to highlight the robust effects of <unk> on serum lipids that was demonstrated in our first in human clinical trial, which could have important implications for cardiovascular risk.

It's well established that Nash and Napa <unk> patients come most often to the cardiovascular comorbidities associated with obesity, which include myocardial infarction stroke and heart failure.

Panther <unk> treatment for 12 weeks, we wrote resulted in robust reductions of total cholesterol LDL cholesterol and triglyceride.

Elevated levels of which are associated with increased risk for cardiovascular disease.

Scott Harris: We will be presenting these findings in an oral presentation at the American Diabetes Association meeting this coming June. We are also making continued progress in the enrollment of our Phase II clinical trial in patients with an active chronic hepatitis B, and expect to read out the results of this trial in the first half of 2023. Recall that the 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. I will now hand the call over to Rich Eisenstadt to give us an update on our first quarter financial results. Thank you, Scott, and good morning again, everyone.

We will be presenting these findings in an oral presentation at the American Diabetes Association meeting this coming June .

We are also making continued progress in the enrollment of our phase II clinical trial in patients with an active chronic hepatitis b and.

And expect to read out the results of this trial in the first half.

Of 2023.

Recall that the virologic effects of Hep T cell are being evaluated in chronically infected patients to enable the combination of <unk> T cell with novel direct acting Antivirals as part of combination therapy for chronic hepatitis b.

I will now hand, the call over to Ritch Allison start to give us an update on our first quarter financial results rich.

Thank you Scott and good morning again, everyone.

Rich Eisenstadt: For today's call, I'll be providing a brief update on Altimmune's first quarter 2022 financial and operating results. More comprehensive information will be available in our Form 10-Q to be filed with the SEC later today. I also will provide some guidance on our expenses for 2022. Altimmune ended the first quarter of 2022 with approximately $180 million cash and cash equivalents compared to $190.3 million at the end of 2021. Turning to the income statement, revenue was minimal in the first quarter of 2022 compared to $800,000 in the same period in 2021.

For today's call I'll be providing a brief update on <unk> first quarter 2022 financial and operating results more comprehensive information will be available in our Form 10-Q to be filed with the SEC later today.

I also will provide some guidance on our expenses for 2022.

<unk> ended the first quarter of 2022 with approximately $180 million of cash and cash equivalents compared to $193 million at the end of 2021.

Turning to the income statement revenue was minimal in the first quarter of 2022 compared to $800000 in the same period in 2021.

Rich Eisenstadt: Our change in revenue for the quarter is primarily due to discontinuation of development activities for our T-COVID and Asia Shield programs and will be demanded going forward. Research and development expenses were $15.1 million in the first quarter of 2022, compared to $11.9 million in the same period in 2021. The expenses for the quarter ended March 31st, 2022, included $10.8 million in direct costs related to the development activities for Pemphidutide and $2.5 million in direct costs related to development activities for hep T cell.

Our change in revenue for the quarter was primarily due to discontinuation of development activities for our T. Covid in Asia shale programs and albeit the amendments going forward.

Research and development expenses were $15 $1 million in the first quarter of 2022 compared to $11 9 million in the same period in 2021.

The expenses for the quarter ended March 31, 2022 included $10 $8 million and direct costs related to the development activities for <unk> and $2 $5 million and direct costs related to development activities for <unk>.

Rich Eisenstadt: 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 the Phase 2 trial Pembidutide, which occurred in April, subsequent to quarter end, and will be reflected in the Q2 balance sheet. General and administrative expenses were $4.4 million in the first quarter of 2022 as compared to $3.8 million in the same period in 2021. The year-over-year change was primarily attributable to increased stock compensation expense.

As a reminder, we will.

One last development milestone of $3 million.

Payable in common shares of the company within 60 days following dosing of the first patient in the phase II trial empathy tide, which occurred in April subsequent to quarter end.

Will be reflected in the Q2 balance sheet.

General and administrative expenses were $4 $4 million in the first quarter of 2022 as compared to $3 8 million in the same period in 2021.

The year over year change was primarily attributable to increased stock compensation expense.

Rich Eisenstadt: Net loss for the three months ended March 31, 2022 was $19.4 million, or $0.44 net loss per share, compared to $14.9 million, or $0.38 net loss per share for the first quarter of 2021. We currently estimate that our research and development expenses for full year 2022, including the $15.1 million reported in Q1, will be approximately $75 million. GNA expenses for the full year 2022 are anticipated to be approximately $19 million. Approximately $8.5 million of these operating costs are for non-cash expenses, including stock compensation and depreciation and amortization.

Net loss for the three months ended March 31, 2022 was $19 4 million or <unk> 44, net loss per share compared to $14 9 million or <unk> 38.

Net loss per share for the first quarter of 2021.

We currently estimate that our research and development expenses for full year 2022, including the $15 1 million recorded in Q1 will be approximately $75 million.

G&A expenses for the full year 2022 are anticipated to be approximately $19 million.

Approximately $8 $5 million of these operating costs are for noncash expenses, including stock compensation and depreciation and amortization.

Rich Eisenstadt: With the added financial flexibility afforded through the delay and initiation of a Phase II trial, PEMPA do tied in that. Our existing cash not only fully funds us through an FLD and 48-week momentum obesity trial data set. But we currently estimate that our cash is sufficient to allow us to operate well into 2024. I will now turn it back over to Vipin for his closing remarks. Vipin.

With the added financial flexibility afforded to the delay in initiation of a phase II trial empathy tightened bash, our existing cash not only fully funds up.

Isn't that L D.

Eight week momentum obesity trial datasets.

We currently estimate that our cash is sufficient to allow us to operate well into 2024.

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

Vipin Garg: 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? Thank you, sir. If you would like to ask a question, please press star 1 on your touchtone phone. You may remove yourself from the queue at any time by pressing star 2.

Thank you chip.

Operator that concludes our formal remarks, and we would like to open the line to take questions.

Would you please instruct the audience on the Q&A procedure.

Thank you Sir.

I would like to ask a question. Please press star one on your Touchtone phone.

May remove yourself from the queue at any time by pressing star two.

Operator: Again, that is star 1 to ask a question. We will pause for just a moment to allow questions to queue. Thank you. Our first question will come from Seamus Fernandez with Guggenheim. Thanks, guys. And, you know, congrats on the quarter. Obviously, good management and execution around the expenses.

Again that is star one to ask a question, we'll pause for just a moment to allow questions to queue.

Thank you our first question will come from Seamus Fernandez with Guggenheim.

Thanks, guys.

Congrats on the quarter, obviously, good management and execution.

Seamus Fernandez: You know, can you help us understand a little bit? You know, obviously, it's great to see the NASH study, you know, really more incorporated into potential strategic options going forward. But maybe you could just give us a little bit of clarity along those lines. You know, how far into 2024 do you think that the cash would likely take us?

Around the <unk>.

Spencers.

Can you help us understand a little bit.

Obviously, it's great to see the Nash study.

Really more incorporated into potential strategic options going forward, but maybe you could just give us a little bit of clarity along those line.

How far into 2024 do you think that the cash would likely take us.

And just wanted to get a sense of that payment that you mentioned rich.

Seamus Fernandez: You know, and just wanted to get a sense of that payment that you mentioned, Rich. You know, just wanted to get a little bit of clarification on the number that you mentioned there that's going to be paid, I think, in the second quarter here. I just kind of missed the absolute number. I couldn't hear if it was 16 or 60, to be honest.

Just wanted to get a little bit of clarification on the on.

The number.

That you mentioned that thats going to be paid I think in the second quarter here just kind of missed the absolute number I couldnt help it was 60% or 60 to be honest.

Seamus Fernandez: And then the second question, you know, is really for Scott Harris. Can you just help us understand what exactly you're looking to understand from these other phase one studies in the context of the diabetic patient population and why the company is conducting those? I think those are some important questions.

And then the second.

Second question.

It was really for Scott Scott Harris.

Can you just help us understand what exactly.

You are looking to understand from these other phase one studies.

In the context of the diabetic patient population.

And why the company is conducting those I think those are those are some important.

Important questions and then just my final question.

Seamus Fernandez: And then just my final question, you know, Vipin, as you kind of think strategically about the market opportunity here, obviously, you've mentioned the competitive landscape. But in the context of the size of this market opportunity, you know, can you just help us better understand, you know, what you think the level of strategic interest is likely to be and when that becomes, you know, sort of a key discussion point for the company based on the data that you're bringing forward? Thanks. Thank you, Seamus.

And as you kind of think strategically about the market opportunity here, obviously, you've mentioned the competitive landscape.

But in the context of the size of this market opportunity.

Can you just help us better understand.

What you think the level of strategic interest is likely to be and when that.

And that becomes.

Sort of a key discussion point for the company.

Based on the data that you are bringing forward. Thanks.

Vipin Garg: Lots of questions there. We'll try to address them one by one. Let me just sort of set the stage in terms of our rationale behind the NASH delay in the NASH study, you know, the 52-week biopsy-proven, biopsy-driven study. As you know, we've got a number of studies going on that will be generating significant amount of data in terms of liver fat reduction, and we think that's going to be sufficient, to sort of drive the value proposition for people to sort of draw the line, and we'll also be getting data from other companies, other players in NASH space during 2022. So if we put all that together, we think we'll have enough information to convince a strategic partner the value proposition that we bring to NASH, which we think will be substantial.

Well, thank you Seamus.

<unk> tried to address them one by one let me just sort of set the stage in terms of our rationale behind the Nash delay in the Nash study.

The 52 week biopsy proven biopsy driven study.

As you know we've got a number of studies going on that will be generating significant amount of data.

In terms of liver fat reduction and we think thats going to be sufficient to sort of drive the value proposition for people to sort of draw. The line and will also be getting data from other companies. Other players in that space. During 2022. So if you put all that together, we think we will have enough information to convince.

As a strategic partner.

The value proposition that we bring to Nash, which we think will be substantial.

Vipin Garg: So given that, what we want to do is focus on obesity, generate as much data as we can, and maintain financial flexibility. It's really driven by that, that we've decided to essentially postpone, at this point, initiation of a Phase II NASH study, which, as you know, are very long, so we're not going to see anything out of that study until sometime in 2024, even if we start that study right now. So it was given all of those considerations, we felt we would still be able to retain the upside value of the NASH indication in our discussions, and I'm pretty sure that a strategic partner would want to pursue both obesity and NASH indications, just like other large pharma players are doing in the incretin space, so there's no question that incretins will play a role in NASH treatment, ultimately, just a matter of timing.

So given that what we want to do is focus on obesity generate as much data as we can and maintain financial flexibility.

And it's really driven by that that we've decided to essentially postponed at this point initiation of a phase II Nash study, which as you know are very long. So we're not going to see anything out of that study until sometime in 2020 full even if we stopped that study right now so he was given all of those considerations.

We felt we would still be able to retain the upside value of the Nash indication in our discussions.

And I'm pretty sure that a strategic partner would want to pursue both to obesity and Nash indications just like other large pharma players are doing in this in the <unk> space. So Theres no question that <unk> will play a role in it.

Nash treatment ultimately in just a matter of timing. So that's the rationale that we are using with that let me just turn it over to rich to talk about the.

Vipin Garg: So that's the rationale that we're using. With that, let me just turn it over to Rich to talk about your questions about the funding and financing, and how long will that last, Rich? Yeah, sure. Thanks, Vipin. Thanks for the question, Seamus. We didn't provide specific guidance on to how deep in the 2024 we'll get.

Questions about the funding and financing.

And how long will that last rich.

Yeah sure Thanks, Jeff and thanks for the question Seamus.

We didn't provide specific guidance on how deep into 2024 woke at that we believe will be sufficient we should have.

Rich Eisenstadt: We believe it will be sufficient. We should have, you know, give or take, you know, approximately a year's cash when we have the data or completion of the momentum trial. So, I hope that that helps. Of course, you know, a lot changes as time goes on, depending on what the data looks like and additional studies that you may or may not need to do. But it is sufficient to gather all the data, get to the FDA and have discussions, and then we believe engage in these potential strategic discussions. Regarding the payout for Spitfire, the amount is $3 million.

Give or take approximately a year cash.

When we have the data.

Our completion of the momentum trial.

So I hope that that helps of course, a lot of changes as time goes on.

Pending on what the data looks like and additional studies that you may or may not need to do.

But it is sufficient to gather all the data.

And have discussions and then we believe engaged in these potential strategic discussions.

Rich Eisenstadt: I'm sorry for the confusion on that. It gets paid within 60 days following the achievement of the milestone, and it will be paid in shares, Seamus. There's a preset formula, and the formula indicates that it will likely result in the issuance of approximately 850,000 common shares of the company. Perfect. That's super helpful. And then just the last question on the diabetes patients, and maybe just an update, if you guys are willing, just to kind of provide a general color on how the obesity study, how the momentum study is recruiting so far, and how you're feeling in terms of that tracking to providing an interim look, whether it be at the full patient population or part of the patient population in the fourth quarter.

Regarding the.

The payout for the acquire the amount is $3 million I'm sorry for the confusion on that it gets paid within 60 days following the achievement of the milestone and it will be paid in shares Seamus Theres a preset formula.

<unk>.

The formula indicates that it will likely result in the issuance of approximately 850000 common shares of the company.

Perfect. That's Super helpful. And then just the last question on the <unk>.

Diabetes patients and maybe just an update.

If you guys are willing just to kind of provide us general color on how the.

Obesity study how.

How the momentum study is recruiting so far and how you are feeling in terms of that tracking to providing an interim look.

Whether it be at the full patient population or part of the patient population in the.

In the fourth quarter.

Rich Eisenstadt: Thanks. Scott, do you want to take the diabetes first? Sure. Thank you, Seamus, for the question. I'll take the diabetes part first, and then I'll finish, with some comments about the momentum study. So as you know, within the obesity population, 80% of that population does not have diabetes. And you're well aware that, What really controls blood sugar chronically in this population is the weight loss that was shown in the STEP trials.

Scott do you want to take the debt piece first sure. Thank you Seamus for the question I'll take the diabetes part first and then I'll finish.

Rich Eisenstadt: The change in hemoglobin A1c at 52 weeks is predominantly driven by the weight loss. So over the long run, we think that this drug will have excellent applications in diabetics. Also, in our phase one study, we saw no perturbations in glucose control measured by fasting blood sugar or hemoglobin A1c.

With some comments about the momentum study.

So as you know within the obesity population, 80% of the population does not have diabetes.

And.

You are well aware that.

What really controls blood sugar chronically in this population is the weight loss that was shown in the step trials the change in hemoglobin <unk> C. At 52 weeks is predominantly driven by the weight loss. So over the long run we think that this drug will have excellent applications in diabetics.

Also in our phase one study we saw no perturbations in glucose control measure by fasting blood sugar hemoglobin, when they want to and in fact as you would have expected with the weight loss that was observed we actually had a reduction of insulin resistance that bodes quite well for the results of what we're going to see in 52 weeks either in the $9.

Scott Harris: And in fact, as you would have expected with the weight loss that was observed, we actually had a reduction of insulin resistance that bodes quite well for the results of what we're going to see in 52 weeks, either in a non-diabetic population or a diabetic population. I think that we felt the obligation at this point to study the effects of pembedutide acutely on aspects of glucose control that are typically studied in more intense phase one studies, such as continuing glucose monitoring and the like. And we really couldn't do that in our current studies without making them too complicated.

<unk> population or a diabetic population.

That we felt the obligation at this point to study the effects of <unk> acutely on aspects of glucose control that are typically studies and more intense phase one studies, such as continuing glucose monitoring and the like and we really couldnt do that in our current studies.

Without making them, making them too complicated so we elected to conduct our committed study and diabetics and Thats what were trying to get out of the study right now I'll answer. The second question about the momentum study and I'm happy to go back and backfill.

Scott Harris: So we elected to conduct a committed study in diabetics, and that's what we're trying to get out of the study right now. I'll answer the second question about the MOMENTUM study, and I'm happy to go back and backfill on that answer I just gave you on the obesity. So the MOMENTUM study is going quite well. We're very enthusiastic with enrollment.

On that answer I, just gave you on the obesity.

So the amendment study is going quite well, we're very enthusiastic with enrolment. We think it's going to enroll very very quickly like most of abuse of these studies too and we have 25 extremely enthusiastic investigators the best guidance I can give you is we'll give you an update when the enrollment in the study completes and tell you what our plans right now.

Scott Harris: We think it's going to enroll very, very quickly, like most obesity studies do. And we have 25 extremely enthusiastic investigators. The best guidance I can give you is we'll give you an update when the enrollment in the study completes and tell you what our plans right now. Right now we're optimistic that we'll have a very meaningful readout at the end of the year, and Seamus Pugliese. And to your question about strategic thinking and the process going forward, I mean, look, the whole obesity space is maturing. I think the latest data from Tres Apatite is helping. It's growing awareness. There'll be a lot of interest from multiple players in this space. That's how we see it.

Right now we're optimistic that we'll have a very meaningful readout at the end of the year.

And Seamus.

I appreciate it.

And to your question about strategic thinking and the process going forward I mean look the whole obesity space is maturing I think the latest data from does appetite is helping its growing awareness there'll be a lot of interest from multiple players in this space. That's how we see it and we are trying to do is really.

Vipin Garg: And what we're trying to do is really generate important data that would put us in the best position to do a robust transaction, partnering transaction around this asset. So a lot of the studies, we've said it many times, we're doing these studies because we think they would add value in our strategic partnering discussions. So I think overall, there are multiple players out there that are going to want to play in this space, and we just want to be ready for that. Excellent. Thanks so much.

Generate important data that would put us in the best position to do a robust transaction partnering transaction around this asset so lot of the studies. We've said it many times we are doing these studies, because we think that would add value in our strategic partnering discussions.

Overall.

There are multiple players out there that are going to want to play in this space and we just want to be ready for that.

Excellent. Thanks, so much I appreciate it.

Vipin Garg: Appreciate it. Thank you. Our next question will come from Yasmeen Rahimi with Piper Sandler. Good morning, team, and thank you for taking my questions. I'm going to go one by one.

Thank you. Our next question will come from Yasmin Rahimi with Piper Sandler.

Good morning team and thank you for taking my question.

Yasmeen Rahimi: Maybe a good place to start off would be, can you comment on the 1B NAFLD study, what you're seeing in regards to discontinuation rates, how many data safety monitoring committees have you had, and what your expectations are in terms of GI tolerability. So just anything safety related to the 1B that you've been previewed to during this time. Could be helpful for us, and then I have a few more.

One by one maybe a good place to start off with B.

Can you comment on one be novel study, what Youre seeing in regards to discontinuation rate how many data safety monitoring committees have you had.

And what your expectations are in terms of Gi Tolerability. So just anything safety related to the <unk> that you have been previewed during this time could be helpful. And then I have a few more.

Scott Harris: Well, thanks for the question, Yasmeen. As you know, we continue to be blind in the study, and I can't give you data that we don't have. I will tell you that from the safety point of view, we're extremely pleased, as we've said before, with the safety profile and tolerability of the compound in that study, as well as the other studies that we're conducting right now. There is no official data monitoring committee for this study.

Well. Thanks for the question you asked I mean as you know we continue to be blinded in the study and I can I can't give you data that we we don't have.

I will tell you that from the safety point of view, we're extremely pleased as we've said before with the safety profile and Tolerability of the compound in that study.

As well as the other studies that we're conducting right now.

There is no official data monitoring committee for this study you wouldn't expect it with a phase one study.

Scott Harris: You wouldn't expect it with a phase one study. However, we have a safety committee that reviews the data from the study in a blinded fashion on a regular basis, and those meetings have not identified any issues to date consistent with what I've said before. Regarding the GI tolerability, we think it's only going to improve going forward. Remember that with phase one studies, the tolerability profile of the compound is less, less optimistic than it would be in Phase 2 and Phase 3. And the reason is, number one, there's less known about the compound at that time.

However, we have a safety committee.

Reviews.

The data from the study in a blinded fashion on a regular basis.

Those meetings have not.

<unk> identified any issues to date consistent with what I've said before.

Regarding the Gi Tolerability, we think it's only going to improve going forward.

Remember that with phase one studies, the tolerability profile of the compound.

<unk> is less.

<unk>.

Less optimistic than it would be in phase II and phase III.

And the reason is number one this less known about the compound at the time there is more.

Scott Harris: There's more heightened, there's more concern about anything that you see. Investigators are heavily attuned to asking patients questions repeatedly. Subjects are admitted to the unit for much of that time, so they're under constant surveillance, and then they come back weekly. That's very different from a Phase II environment, like the Momentum Study, when patients would be coming back, say, every two to four weeks and not being monitored constantly. And it was well shown in the terzepatide and thermaglutide programs that when they went from Phase I to Phase II, that they had a tremendous decrease in their adverse events. We were very happy with the tolerability profile that we had with PEMBA-DUTAD in our Phase 1 program. We had no adverse event discontinuations.

Heightened.

This is <unk>.

More concern about anything that you see investigators are heavily attuned to asking patients questions repeatedly subjects are admitted to the unit for much of the time. So they are under constant surveillance and then they come back weekly.

That's very different from our phase II environment like the momentum study when patients will be coming back.

Every two to four weeks and not being one monitor constantly and was well shown in the tours appetite and <unk> programs that when they went from phase one to phase two they had a tremendous three curious in their adverse events. So we.

We were very happy with the Tolerability profile that we had with temp do tighten our phase one program, we had no adverse event discontinuation.

Yasmeen Rahimi: We think it's only going to get better going forward. Um, thanks, Scott. I just want to clarify on the commentary you made. One, do you get notified when a discontinuation occurs in the NAPFLD study or the Momentum study, and have you been notified? Yeah, I mean, we are notified.

We think it's only going to get better going forward.

Thanks, Scott I just wanted to clarify on the commentary you made one do you get notified women discontinuation occurs and then Apple study or the momentum study and have you been notified.

Scott Harris: I'm not, you know, free to speak on this on a specific basis other than to say that we're very happy with what we're seeing right now, about it. And then when you made the remarks that the GI tolerability could be looking more favorable in a Phase 2 study, are you saying that the Phase 1b NATFOLK study's GI profile could be, given the protocol is more similar to the 1b OBESE data set that we have seen, or the execution of the 1b more like the Phase 2 momentum? Could you clarify, please?

Yes, I mean, we are notified.

Free to speak on this on on a specific basis other than to say that we're very happy with what we're seeing right now.

Got it and then when you made the remark that.

Safety.

Gi Tolerability tolerability could be looking more favorable.

In our phase two study are you, saying that the phase one <unk> study Gi profile could be given the protocol is more similar to that one be obese datasets that we have seen.

With the execution of the one before like the phase III momentum could you clarify please.

Scott Harris: Yeah, I think that clearly, as you go from phase one to phase three, the tolerability profile of the compound improves. So one would expect, based on that, that the tolerability in a phase two might even be better than a 1B. But once you get the patients out of the phase one unit, and you know more about the compound, and you have more confidence in the investigators with what you've seen, it gets better.

Yes, I think clearly as we go from phase one to phase III. The tolerability profile of the compound improves. So one would expect based on that that the tolerability in a phase III might even better would be better than a one b, but once you get the patients out of the phase one unit.

And you know more about the compound.

You have more confidence of the investigators with what you've seen it gets better. So we expect that the tolerability in a phase <unk> study will be better than it was in the first in human study and that it will progressively get better going forward.

Scott Harris: So we expect that the tolerability in the phase 1B study will be better than it was in the first in human study, and that it will progressively get better going forward. Thank you. And then last question, any more commentary on like, what exactly we should be expecting out of the interim? Like, what goes into your decision to decide whether you're going to pick?

Thank you and then last question.

Any more commentary on Mike what exactly we should be expecting out of the interim like what goes into your decision to decide whether you want to pick.

Yasmeen Rahimi: you know, 20 patients per arm or 30 patients per arm. Now it's been, what, about a month and a half, two months into the study. Like, can you help us narrow down what exactly, how big the interim analysis will include? And thank you for taking my question. Yeah, happy to answer that for you, Yasmeen. As you know, we're right now in the beginning of May. We still have a long way to go with a very rapid recruitment.

All 20 patients per arm or 30 patients per arm.

Now it's been about a month and a half two months into the study like can you help us narrow down what exactly how big the interim analysis will include and thank you for taking my question.

Yes happy to answer that for you has been as you know.

We're right now in the beginning of May we still have a long way to go with a very rapid recruitment.

Scott Harris: We're simply going to have to look at the data at the time that we have to do the cutoff and, you know, make that decision about whether it's a complete set or if it's an incomplete set, how many patients are in it. Based on our current projections, we think that the amount of subjects included in that interim analysis, if not the complete set, will be meaningful, enough to be convincing of the data that's being seen. And that's the best guidance I can give you until we see how enrollment is going. And when do you when you make that decision?

Simply going to have to look at the data at the time that we have to do the cutoff and.

Yasmeen Rahimi: When is that time period? Is this in July then? Or at what point? Probably in July.

Make that decision about whether it's a complete set or if it's an incomplete set.

How many patients are in it based on our current projections, we think that the amount of subjects included in the interim analysis, if not the complete set will be meaningful.

Enough to be convincing of the data that's being seen and Thats. The best guidance I can give you until we see how enrollment is going.

Scott Harris: Yeah, probably in that time frame, the middle of the year. Okay, great. Thank you. You're welcome.

And when do you when do you make that decision when.

Is that time period.

In July then or at what probably mid July .

Probably in that timeframe in the middle of the year.

Okay, great. Thank you Youre welcome.

Yasmeen Rahimi: Thank you. Our next question will come from Liisa Bayko with Evercore ISI. Hi there, how are you? Good morning, Liisa. Can you hear me?

Thank you. Our next question will come from Lisa <unk> with Evercore ISI.

Hi, there how are you.

Good morning, Lisa.

Good morning.

Liisa Bayko: Good morning. Yes, just for I want to ask quickly for the study you're doing that does not include diabetics, the obesity study, are you just are you not at a point where you can include diabetics now? I know I know you have an earlier study. I'm just curious why not just make it kind of all comers, Thanks for the question, Liisa.

I wanted to ask quickly for the study Youre doing that does not include diabetic obesity study.

Now to the point, where you can include diabetic.

I know you have an earlier study of various line items.

I'll summarize in a way.

Okay.

Scott Harris: Well, you know, typically in obesity studies, Liisa, if you look at the STEP program, the SURPASS program, the SURMOUNT program, in these Phase II obesity studies, in Phase III, diabetics and non-diabetics are not included, and I believe that the agency would want it that way as well. So, consequently, you have to choose one or the other, and we think that the more meaningful readout is going to be in the non-diabetics. Obviously, at some point, we do an obesity chronic study, but that phase two study right now is in non-diabetics.

Thanks for the question Lisa.

Typically in obesity studies, Lisa if you look at the step program the surpass program their <unk> program.

In these phase II obesity studies in phase III diabetic and non diabetics are not included.

And I believe that the agency would want it that way as well.

So consequently, you have to choose one or the other and we think that the more meaningful readout is going to be in the non diabetics. Obviously at some point, we do an obesity chronic study, but that phase II study right now as a non diabetics and we think that taking the lead.

Scott Harris: And we think that taking the lead, given the precedent with Step 1 and also Surmount 1, which are non-diabetics, it just makes sense that we match that by doing non-diabetics in Momentum. Yeah, the recent terzapatide data was all non-diabetics. Exactly. Yeah.

Given the precedent with step one and also surmount, one which are non diabetics. It just makes sense that we matched up by doing non bio diabetics and momentum yes. The recent debt does appetite data was all non diabetics exact weekend, so thats pretty standard in the obesity space co mingled them in large studies.

Scott Harris: So, that's pretty standard in the obesity space to not co-mingle them in large studies. Do you see the epidemic data as kind of your new benchmark in a way? Yeah, so, you know, we've been obviously looking at the whole landscape in obesity. And I think first of all, let me say that, It's really validating that the dual agonism approach is becoming more validated now. Clearly, we can see benefit over just pure GLP-1 approach. So, sort of the first benchmark was 15 to 20 percent of that 15 percent range.

Do you see the appetite data kind of your new benchmark in a way.

Yes.

Yes, so we've been obviously looking at the whole landscape in obesity I think first of all let me say that.

It is really validating that the dual agonism approach is becoming more validated now clearly we can see benefit over just pure <unk> approach. So you start off the first.

Benchmark was 15% to 20% of that 15% range. We just have crossed the 20% Mark. So does that does appetite as you know has about 20% to 22% that weight loss.

Vipin Garg: We just have crossed the 20 percent mark. So, Tazepatite, as you know, has about 20 to 22 percent weight loss. And that's great because I think the interest in multi-agonism is going to grow with this. So we now know what GLP-1 and GIP can do. The question is, what can glucagon combined with GLP-1 do? Obviously, we have some data at this point. And just to put things in perspective.

And that's great because I think.

The interest in multi agonism, he is going to grow with this so we now know what <unk> and GI Beacon do the question is what can glucagon combined with <unk> one one.

We have some data at this point and just to put things in perspective.

Vipin Garg: Atrazepatite showed about 22 percent, 20 to 22 percent after 72 weeks. We have shown 10% weight loss after just 12 weeks, one-sixth the time of Zepatite data. So we feel very comfortable that we will be able to at least meet, perhaps surpass that number as we go towards 48 weeks. So not only do we expect to be greater than Zepatite, but also much faster in terms of getting there.

<unk> died showed about 22%, 20% to 22% after 72 weeks.

We have shown 10% weight loss after just 12 weeks one sixth the time.

Does <unk> data, so we feel very comfortable.

That we will be able to at least meet perhaps a fast that number as we go towards 48 weeks. So we have not only we expect to be greater than does appetite, but also much faster in terms of getting there.

Vipin Garg: In our 48-week study, we could already be approaching those numbers. So we feel very good about our prospects based on our Phase I data. Scott.

In a 48 week study, we could already be approaching those numbers. So we feel very good about our prospects based on our phase one data.

Scott and then that's helpful.

Scott Harris: Okay. Yeah, Liisa, I'll add to Vipin's comments that we're extremely excited by the prospect of delivering these results, without dose titration. We think this is a very, very important commercial advantage, both for patient satisfaction, patients who want to lose weight faster while they're paying for the drug in the first five months of therapy with terzepatide and dose titrating, and also the ease that it gives physicians for prescribing who really do not want to be involved in managing complex dose titration. As well, one other thing I would point out is that our lipid profile appears to be superior to that of both terzepatide and semaglutide. So you get the weight loss.

Yeah, Lisa I'll add to <unk> comments that we're extremely excited by the prospect of delivering this these results without dose titration. We think this is <unk>.

Very very important commercial advantage, both for patient satisfaction patients, who want to lose weight faster, while they are paying for the drug and the first five months of therapy with tours appetite dose titrated.

And also the ease that it gives physicians for prescribing, who really do not want to be involved and.

Managing complex dose titration.

As well one other thing I would point out is that our lipid profile appears to be superior to that of both tours appetite and <unk>. So you get the weight loss, it's certainly very important and it's very pleasing to people and doctors, but what you really want to do is decrease the co morbidities and you achieved that.

Scott Harris: It's certainly very important, and it's very pleasing to people and doctors. But what you really want to do is decrease the comorbidities. And you achieve that in many ways by reducing the lipids.

In many ways by reducing the lipid so the meaningful aspects of weight loss.

Scott Harris: So the meaningful aspects of weight loss, have to be translated into lipids to reduce the cardiovascular risk, and we think we have a superior profile based on the inclusion of glucagon over the monotherapy or the dual therapy that includes GIP but not glucagon. Okay, you seem to have pretty, I mean, so far it looks like you have pretty rapid weight loss at the beginning. I'm assuming this is not linear, right?

Have to be translated into lipids to reduce cardiovascular risk and we think we have a superior profile based on the inclusion of glucagon over the monotherapy or the dual therapy that includes TRP, but not glucagon.

Okay.

And so far it looks like you had pretty rapid weight loss at the beginning.

I'm, assuming that does not linear right.

Okay.

Not really level off and how do you think about the shape of the curve and how predictive do you think thats early.

That is.

For more of the long term.

Hi.

Sure Hey, Lisa This is Scott Roberts.

Liisa Bayko: So it'll start to, probably level off is how do you think about the shape of the curve and how predictive do you think this early effect is? for more of the long term weight loss. Sure. Hey, Liisa, this is Scott Roberts.

Scott Roberts: You know, when we look at the totality of the data out there, and this includes, you know, the STEP studies and the SURPASS study. Studies. You know, we see a relationship between, you know, the initial slope of the weight loss. And we're the final weight loss ends up, you know, and and so we're encouraged because of that, because right now we have the greatest rate of weight loss, you know, certainly through 12 weeks. Will that slope eventually change over a year?

When we look at the totality of the data out there and this includes the step studies and the surpass study.

Studies.

We see a relationship between the initial slope of the weight loss and where the final weight loss ends up and so.

<unk> because of that because right now we have the greatest rate of weight loss.

Through 12 weeks will that will that slope eventually change over a year I think that that's likely but if you look at the data there's a relationship there at least we believe strongly.

Scott Roberts: I think that that's likely. But if you look at the data, there's a relationship there, at least we believe strongly, that the bottom is really set by the initial rate. Interesting. It probably helps and encourages people to stay on drugs and everything, right? That's right.

At the bottom is really set by the initial rate.

Interesting it probably helps and encourages people to.

Jonathan everything right.

Liisa Bayko: They're saying, well, that kind of goes to those titration and the fact that they're getting the full dose right out of the gate. And so it happens rapidly. They feel good about that.

And they're saying one of that kind of goes to those titration in fact that they are getting the full dose right out of the gate and so it happens rapidly they feel good about that and then there seems to be this relationship where the nadir is really set by the initial slope.

Scott Roberts: And then there seems to be this relationship where the nadir is really set by the initial slope. Okay, interesting. And then just finally, can you kind of maybe qualify, how much are you spending on the PEP T cell program? And like, is there any sort of interim before the readout next year where you could kind of, and I'll make a go no go if you want to continue kind of spending on that program just because you know, The majority of the value here, from an investor perspective, is in the obesity program and hep B has just been such a tough area, unclear, you know, commercial opportunity, and it's just a difficult space. It's been difficult for people. I'm just wondering kind of if you can make a kind of some kind of early read and if it's even worthwhile, depending on how much you're spending.

Okay. Thanks.

And then just finally can you kind of maybe quantify how much you're spending on the.

T cell program and like is there any sort of interim before the readout next year, where you could kind of.

And they'll make a go no go if you want to continue kind of spending on that program just because.

The majority of the value here.

From an investor perspective is an obesity program in Hefei assistance, such as health Ariane.

No.

Unclear.

Commercial opportunity and it's just a difficult space than difficult for people.

Just wondering kind of if you can make a kind of some kind of early read and if it's even worthwhile depending on how much we're spending on it.

Liisa Bayko: Yeah, that's a that's a good question, Liisa. And we are, you know, we track that all the time. So, you know, we think towards the end of the year, we'll be able to determine, I think main driver is going to be the rate of enrollment. It's very difficult trials to enroll, particularly in the COVID setting, because these are international studies. And COVID keeps flaring up in different parts of the world. So things shut down.

Yes, that's a good question, Lisa and we tracked that all the time. So we think towards the end of the year, we'll be able to determine I think main driver is going to be the rate of enrollment today difficult trials to enroll particularly in the <unk> setting because these are international studies.

And Colby keeps flaring up in different parts of the world. So things shut down so we hear you and we at this point that you can do the math.

Most significant spend on most of the majority of the spend is on <unk>. So we think that has value to finishing that study because without that study you really cannot.

Vipin Garg: So we we hear you. And we at this point, as you can do the math, you know, you know, most significant spend or most of the majority of the spend is on Pembedutide here. So we think there is value to finishing that study, because without that study, you really cannot make the argument about combining hep T cell with another antiviral. So we need that data. But we'll evaluate that at the end of the year. And if we need additional flexibility, clearly that's a level that we can pull at that point.

Make the argument about combining <unk> with <unk>, so we need that data.

But we'll evaluate that at the end of the year and if we need additional flexibility clearly that's a lever that we can pull at that point.

Liisa Bayko: Okay, thank you guys. Thank you. Our next question will come from Mayank Mamtani with B. Riley Securities. Good morning, team.

Okay. Thank you guys.

Thank you. Our next question will come from my Young Man, Tommy with B Riley Securities.

Mayank Mamtani: Thanks for taking our question. So for conference data presentation this quarter, could you talk to what we should focus on in terms of understanding the differentiating attributes of family, but also, maybe specifically at ADA, what might be the data sets, you know, that weren't maybe part of Lilly's top line press release, just things that you're looking out for at ADA, and then I have a couple of follow, Scott. Yeah.

Good morning, Deane. Thanks for taking our question. So conference data presentation. This quarter could you talk to what you should focus on.

In terms of understanding the differentiating attributes of <unk>, but also maybe specifically at <unk>.

What might be the data.

That would maybe by the release topline press release.

Things that Youre looking out for that and then I have a couple of follow ups.

Scott Yes.

Scott Harris: So, Mike, thanks for the question. You know, we'd highlight the differentiating features are number one, the potential to achieve even higher levels of weight loss, with Penvadutide than the other compounds that have been studied both so far, as Scott mentioned in his reply earlier, the rate of weight loss initially lends us to believe that the final weight loss that we will achieve will be higher. We're very optimistic about that. Second, we think the absence of dose titration is extremely important, because we think that that's right there where the pen hits the prescription pad.

So Mike Thanks for the question.

We'd highlight the differentiating features are number one.

The potential to achieve even higher levels of weight loss with <unk> then the other compounds that have been studied so far as Scott mentioned.

His reply earlier the rate of weight loss initially lenses to believe that the final weight loss that we will achieve will be higher we're very optimistic about.

Second we think the absence of dose titration is extremely important.

<unk>, we think that Thats right, there, where the pen hits the prescription pad.

Scott Harris: Physicians are going to prefer this. Much more to regiments that they have to follow over five months with a physician extender or some other kind of help. In the primary care setting, when the primary care doctor has eight minutes in front of the patient, to manage this is really not feasible and it's only going to get worse.

And physicians are going to preference prefer this.

Much more to regiments that they have to follow over five months with a physician extender or some other kind of health and in the primary care setting when the primary care Doctor has.

And that's in front of the patient.

To manage this is really not feasible and that's only going to get worse.

Scott Harris: And finally, we think we differentiate strongly on lipids because the effects of GIP and GLP-1 are mediated indirectly through weight loss, and the lipids are mainly a hepatic event. And as you know, we have tremendous reductions in liver fat, but that also represents the mechanism for the serum lipids, and that's why the serum lipids decrease so much. And that's the direct effects of glucagon on the liver and the lipids, which is well described in the literature.

And finally, we think we differentiate strongly on lipids.

The effects of <unk> and G. L. P. One are mediated indirectly through weight loss and the lipids or mainly a hepatic event and as you know we have tremendous reductions in liver fat, but that also.

<unk> represents the mechanism for the serum lipid so thats why the <unk> lipids decreased so much.

And thats the direct effects of glucagon on the liver and the lipids, which is well described in the literature. So we think that for lipid reduction which is which.

Scott Harris: So we think that for lipid reduction, which is what... What physicians are going to focus on, they're going to see pembidutitis having superior attributes. We're seeing effects on lipids that are similar to statins and fibrates in terms of reduction in total cholesterol, LDL cholesterol, and triglycerides. With regards to ADA, obviously, there's going to be other compounds that are being presented at that time. I am expecting to see some data from Lilly and their dual and triple agonists. We'll have to wait and see if and what they present, and that will be of extreme interest as well to us. But we'll be on the podium.

Which.

What physicians are going to.

Focus on they're going to see <unk> as having superior attributes we're seeing effects on lipids that are similar to statin and fiber routes in terms of the reduction in total cholesterol LDL cholesterol and triglycerides.

With regards to HCA obviously.

Lee there's going to be other compounds that are being presented at that time.

<unk>.

Expecting to see some data from Lilly and their dual and triple agonist, we will have to wait and see if and what they present and that will be of extreme interest as well to us, but we'll be on the podium will be presenting the results of our phase one trial, Sam Cline, who is extremely well known name.

Scott Harris: We'll be presenting the results of our Phase I trial. Sam Klein, who is an extremely well-known name in obesity research from WashU, will be presenting that, and we're really looking for a great session. Great, thanks for that color.

And obesity research from wash U will be presenting that and we're really looking for a great session.

Mayank Mamtani: And then now that you have some cost savings from the 52-week NASH study and you talk about this, you know, broad cardiometabolic benefit, I was just curious, maybe it's still early days, but we are hearing in pregnant therapies getting to CV outcome trials. So is that sort of part of your plan, initial discussions? And is that in any way big then, you know, as you think about the phase three trial design, you know, 2023, 2024? Well, thank you for the question, Mayank.

Great Thanks for that color.

And then now that you have some cost savings from the 52 week study.

You talk about this.

<unk>.

Benefit.

I was just curious maybe it's still early days, but.

Heading.

<unk>.

Got it.

Outcome droughts or is that sort of bottom.

<unk>.

Any sort of discussions and is that in any way big Ben.

As you think about that they include driving to that grant.

<unk> onwards.

Well. Thank you for the question, Mike as you know the CV outcome trials for trials that you do predominantly after approval and maybe even in this space now exclusively after approval.

Scott Harris: As you know, the CB outcome trials are trials that you do predominantly after approval, and maybe even in this space now exclusively after approval. So although our eyes are on it, it's something that's really not on the drawing board right now. At this point in time, we're looking at the surrogate markers, which should be very predictive of the outcomes, and that would be the lipids. I mean, that's your best marker of cardiovascular risk that we have.

So although our eyes are on it and it's something that's really not on the drawing board right now.

This point in time, we're looking at the surrogate markers, which are should be very predictive of the outcomes and that would be the lipids I mean thats your best marker of cardiovascular risk that we have so at this stage of development in the absence of an outcomes trial, which is some time away.

Scott Harris: So at this stage of development, in the absence of an outcomes draw, which is some time away, we'd be focusing on the lipids, and it looks really good. Yeah, the other thing I would just add, Mayank, is that once we have the Phase 2 data, our focus will then shift to immediately having an end of Phase 2 meeting with the FDA. So that would be another important milestone. That's really going to be our first substantive discussion with the FDA on the Phase 3 plan for Pembedutide for obesity. And then just my final... Tactical question on momentum. So now you're at 25 sites.

We'd be focusing on lipids and it looks really good.

Yes, the other thing I would just add <unk> is that once we have the phase II data. Our focus will then shift to immediately having an end of phase II meeting with the FDA. So that was the another important milestone that's really that's really going to be our <unk>.

Substantive discussion with the FDA on the phase III plan for <unk> for obesity.

Understood.

Yes.

Mayank Mamtani: Any chance you're able to comment how these sites compare to other ingredient studies, you know, in terms of patient enrollment per month, how it ramps up as you know, things progress from screening to dosing? I mean, do you see any issues of competitive enrollment or, you know, if running placebo controlled trials is an issue in the future? And if like not having titration is critical, you know, element of enrollment, not just, you know, real world prescriptions later on? Thanks, Mayank. There are several parts of that question. Let me try to hit on them, and if I don't backfill fully.

That's a good question on <unk>.

Momentum so now you're at 25 sites.

And you can make a.

Comment how these sites compared to other <unk> studies.

In terms of patient enrollment by mind, how it ramps up as things progress from screening to dosing I mean, do you see any issues of competitive enrollment.

Yes.

Placebo controlled rather than issue in the future.

And if not having degradation good to go.

The element of enrollment not just the otherwise description may go on.

Thanks, Mike there are several parts of that question, let me, let me try to hit on them.

If I don't backfill fully.

Sure.

Please ask your question again.

Scott Harris: Please ask your question again. Regarding the sites that we have in the trial, each of those sites are accomplished sites in obesity. Each have a track record, not only on enrollment, in rapid enrollment, but also retention, which is very important because we're focusing on that. There is a tremendous, and I want to emphasize this, tremendous amount of investigator enthusiasm. Investigators want to be in this space, and boy, patients really want to be in these studies.

Regarding the sites that we have in the trial each of those sites are accomplish sites and obesity each have a track record not only on enrollment and rapid enrollment, but also retention, which is very important because we're focusing on that.

There is a tremendous and I want to emphasize this tremendous amount of investigator enthusiasm investigators want to be in this space and boy patients really want to be in these studies. There is always a challenge in these studies of keeping people in the studies, particularly the placebos so the enthusiasm in the investigator.

Scott Harris: There's always a challenge in these studies of keeping people in the studies, particularly the placebos. So the enthusiasm in the investigator and the enthusiasm that's given to the patient to stay in the trial, you know, with lots of attention, you know, help with their lifestyle management of the like, is extremely important. And the ability to keep the placebos in the trial are important as well. None of these sites have competitive studies and, you know, we don't think that the titration or the absence of it is any issue of anything.

<unk>.

And the enthusiasm that is given to the patient to stay in the trial.

With lots of attention.

Help with their lifestyle management of the like.

As is extremely important and the ability to keep the placebos in the trial.

Important as well none of these sites have competitive studies.

And.

We don't think that the.

Titration or the absence of it is any issue if anything it's a plus because patients are looking forward to more rapid weight loss when they come into the program and that's why they're coming in as the potential for more rapid weight loss and the greater weight loss.

Scott Harris: It's a plus because patients are looking forward to more rapid weight loss when they come into the program. And that's why they're coming in is the potential for the more rapid weight loss and the greater weight loss. I just want to thank you for taking our questions. Thank you.

Understood. Thanks for taking our questions.

Sure.

John Wollenden: Our next question will come from John Wollenden with J&P Security. Hey, thanks for taking the question and congrats on the progress. I guess I had a high level question on a decision to focus on obesity, which we appreciate, but also, you know, understanding the opportunity in NAFL. Minority Leadership Trust. You know, how PEMV could be used in NASH if you're out there in obesity as well. Yeah, no, that's a good question, Jonathan.

Thank you. Our next question will come from Jon Windham with JMP Securities.

Yes.

Hey, Thanks for taking the question and congrats on the progress.

I guess at a high level question on the decision to focus on obesity, which we appreciate but also understanding the opportunity in Nashville.

It means more on your hands of someone else's how do you have these discussions with strategics that.

You are successful in obesity won't bet pardon the pun to eat into an Apple opportunity just wondering how someone else would think of.

How <unk> could be used in Nash, if you're out there in obesity as well.

Yes.

Good question Jonathan.

Vipin Garg: Let me just say this, that we've always said that the path to treating NASH is through obesity. So if you look at other players that are working in GLP-1 space or GLP-1, you know, GIP space as well, they're all following both obesity and NASH. We think the data that we have generated so far on FLD speaks for itself and the data that we will generate will be sufficient to connect the dots between obesity and NASH.

Let me just say this that we've always said that.

<unk> to treating Nash is through their obesity.

So if you look at other players that are working in <unk> space of <unk>.

Gi space as well they are all following both obesity and Nash, we think the data that we've generated so far on <unk> speaks for itself and the data that we will generate will be sufficient to do connect the dots between obesity and Nash so just pursuing obesity.

Vipin Garg: So just pursuing obesity doesn't exclude you from pursuing NASH. So whoever we, you know, we partner with, ultimately we think they would value NASH in addition to the obesity indication. And really that would be the ideal way for us to proceed with both those indications in parallel. By the way, we will be ready to execute a Phase II NASH study as soon as possible. So we're making all the preparations. We're not sort of putting the pen down.

It doesn't.

Glued you from pursuing Nash so whoever we partner with ultimately we think they would value Nash. In addition to the obesity indication and really that would be the ideal way for us to proceed with both of those indications in parallel by the way, we will be ready to execute a phase III phase II Nash study.

As possible. So we're making all the preparations we're not sort of putting the pen down we just not going to won't do undertake major expense and stop the study, but we will be ready to pull the trigger on that which we think has value. So we are preparing for all of that needs to be done in order to stop that study as quickly as possible.

John Wollenden: We're just not going to undertake major expense and start the study, but we'll be ready to pull the trigger on that, which we think has value. So we are preparing for all that needs to be done in order to start that study as quickly as possible. Got it. And I guess to that end, Rich, I kind of missed in the prepared remarks the 2022 guidance. I was hoping you could run through that one more time.

Got it.

And I guess to that end rich I kind of missed in the prepared remarks. The 2022 guidance I was hoping you could run through that one more time.

Rich Eisenstadt: Sure, I'd just relegate the two operating cost guidance, Jonathan, so R&D expenses for the year are projected to be about $75 million for the full year, so that's inclusive of the $15 million we spent in Q1, and then GNA is around $19 million in expense, and of all that expense about eight and a half million of that is non-cash. Very helpful. Thanks again.

Sure.

The.

I, just really get to operating cost.

Guidance, Jonathan So R&D expenses for the year are projected to be about $75 million for.

For the full year. So that's inclusive of the $15 million, we spent in Q1.

And then G&A is around $19 million of expense.

And all of that expense about $8 5 million of that is non cash.

Very helpful.

Thanks again.

Mhm.

Patrick Trucchio: Thank you. Our next question will come from Patrick Trucchio with HC Rainwhite. Good morning, team. This is Jason on for Patrick.

Thank you. Our next question will come from Patrick <unk> with H C. Wainwright.

Scott Harris: And so I have a couple questions on the HEP T cell program. So the first one is what do you what do you view as the ideal antiviral to combine with HEP T cell? And what is the current status of potential collaboration on HEP T cell? And then I have two follow up questions. I think that from a combination standpoint, certainly agents that knock down surface antigen are the most likely candidates. I think that we look towards the RNAi type of inhibitors. Those are the natural selections.

Good morning team this is Jason on for Patrick.

I have a couple of questions on the Hep T cell program.

So the first one is what do you what do you view as the ideal anti Virals combined with <unk> T cell and what is the current status of the potential collaboration I'll have T cell and then I'll have two follow up questions after that.

Yes.

Yes, Scott, Yeah, Hey, Patrick.

From a combination standpoint, certainly agents that knock down surface antigen.

<unk> likely candidates I think that we look towards the the RNA AI type of inhibitors. Those are those are the natural selection. There are others that are out there whether that other nucleic acid approaches.

Scott Harris: There are others that are out there, whether the other nucleic acid approaches. The capsids may have some use, but I think we're really focused on significant knockdown of surface antigen, creating a window, a better opportunity then for a hefty cell to go in and activate those T cells. Okay, great. So just kind of, so to kind of look forward to the data readout for the first half, are we also basically anticipating for clearance of surface antigen initial data set?

<unk> may have some use but I think we're really focused on significant knockdown of surface antigen, creating a window a better opportunity than four for hefty sell to go in and activate those T cells.

Okay, great. So just kind of so to kind of look forward to the data readout for the first half hour real so basically anticipating for clearance of surface Amgen the initial dataset.

Scott Harris: Yes, and I think in terms of your question about partnering status, that kind of goes hand-in-hand. We've got initial discussion with folks pending the data, so it's really a question of who do we combine with, and it's for them as well as for us, which is the best combination, and that would only be sort of determined after we have the data. Okay, great. That's real helpful to know.

Yes.

In terms of your question about partnering status that kind of goes hand in hand, we've got initial discussion with folks pending.

Pending the data so it's really a question of who do we combine with them for them as well as for US, which is the best combination and that would only be sort of determined.

After the after we have the data.

Patrick Trucchio: And then the kind of last question, Hepti, so will we have any functional cure rate in the initial data? Or will we wait for another six months to fully assess? And what rate of functional care would you anticipate in this trial? Scott.

Okay great.

It is now and then kind of last question on Hep C. So when we have any functional cure rate and the initial data or will we wait for another six months to fully assess.

And what rate of functional cure would you anticipate in this trial.

Scott.

Scott Harris: Yeah, the trial's really not set up to look at functional cure. This is meant to look at virological endpoint. We think that that's the data we need to take the next important step in the program. So it's really not focused on functional cure. Certainly, we'll be looking for that. Would not, you know... Go beyond that.

The trial is really not set up to look at functional cure. This is meant to look at.

At very logical endpoint, we think that thats the data we need to take the next important step in the program. So it's really not focused on functional cures certainly will be looking for that would not.

No.

Go beyond that again.

Patrick Trucchio: Again, the study is focused on the neurological endpoints, validating the approach, and setting us up then for a combination study that I think everybody who's in this area understands is really going to be the successful path forward. Hi, great. Thank you so much.

The study is focused on the virological endpoints.

Validating the approach and setting US up then for a combination study that I think everybody who is in this area understands is really going to be the successful path forward.

Alright, great. Thank you so much.

Operator: Thank you. It appears we have no further questions at this time. I would now like to turn the program back over to our presenters for any additional or closing remarks. Yes, 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 nice day.

Thank you. It appears we have no further questions at this time I would now like to turn the program back over to our presenters for any additional or closing remarks.

Yes. 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 nice day.

Sure.

Thank you ladies and gentlemen. This concludes today's event you may now disconnect.

Yes.

[music].

Okay.

[music].

Sure.

[music].

[music].

[music].

Operator: Thank you, ladies and gentlemen. This concludes today's event. You may now disconnect. Good day, ladies and gentlemen, and welcome to the Altimmune, Inc. Q1 Earnings Conference Call. At this time, all participants are in a listen-only mode.

Good day, ladies and gentlemen, and welcome to the Aten Ann Inc. Q1 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 star.

Rich Eisenstadt: 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 zero on your touchtone phone. As a reminder, this call is being recorded. I would now like to introduce your host for today's conference call, Rich Eisenstadt, the Financial Officer of Altium, Rich, you may begin. Thank you, Katie, and good morning, everyone.

Zero on your Touchtone phone as a reminder, this call is being recorded I would now like to introduce your host for today's conference call Rich I've missed that.

That's the opposite of loyalty in.

You may begin.

Thank you Kate and good morning, everyone.

Rich Eisenstadt: Thank you for participating in Altimmune's first quarter 2022 earnings conference call. Members of the Altimmune team joining me on the call today are Vipin Garg, our Chief Executive Officer, Scott Roberts, our Chief Scientific Officer, and Scott Harris, our Chief Medical Officer, fund the prepared remarks, we will hold a question and answer session. Press release with our first quarter 2022 financial results was issued this morning and can be found on the investor relations section of the company's website.

Thank you for participating in <unk> first quarter 2022 earnings conference call.

Members of the ultimate team joining me on the call today are different guard, 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 first quarter 2022 financial results was issued this morning and can be found on the Investor Relations section of the company's website.

Rich Eisenstadt: 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 the ongoing conflict in Ukraine, COVID-19, and the 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.

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, <unk> 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 the ongoing conflict in Ukraine, COVID-19, and the 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.

Rich Eisenstadt: I'd 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, Thursday, May 12, 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 Altamein's website. With that, I will now turn the call over to Dr. Vipin Garg, Chief Executive Officer of Altamein. Thank you, Rich, and good morning, everyone.

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 Thursday May 12, 2022, and the company does not undertake any obligation to update any of these forward looking statements to reflect events or circumstances.

Occur on or after today's date.

As a reminder, this conference call is being recorded and will be available for audio replay on <unk> website.

With that I will now turn the call over to Dr. Vipin Garg, Chief Executive officer of Alchemy.

Thank you rich and good morning, everyone.

Vipin Garg: We appreciate you joining us today for a discussion of our first quarter 2022 financial results and business update. We continue to advance multiple clinical trials for our lead product candidate, Pembidutide, a GLP-1 glucagon dual receptor agonist, and are excited about reporting important data from these trials in the second half of 2022. Last month, we announced the initiation of the 48-week Phase 2 Momentum Trial of Pambidu Tide in subjects with obesity or who were overweight. That trial is ongoing at multiple sites in the United States with Dr. Lou Oroni.

We appreciate you joining us today for a discussion of our first quarter 2022 financial results and business update.

We continue to advance multiple clinical trials for our lead product candidate <unk> died a DLP one glucagon dual receptor agonist and are excited about reporting important data from these trials in the second half of 2022.

Last month, we announced the initiation of the 48 week phase III momentum trial of <unk> died in subjects with obesity or who are overweight.

That trial is ongoing at multiple sites in the United States with Dr. Lu our oney.

Vipin Garg: Professor of Clinical Medicine at Weill Cornell Medical College and a leading authority in obesity and obesity clinical trials, serving as the principal investigator. Dosing has commenced. And a planned interim analysis to assess changes in body weight after 24 weeks of treatment is expected to read out in the fourth quarter of 2022. Enrollment in the Phase 1b Non-Alcoholic Fatty Liver Disease, or NAFLD, trial has been completed, and data readouts for weight loss and liver fat reduction at 12 weeks of treatment are expected in the third quarter of 2022.

Professor of clinical medicine at Weill, Cornell Medical College, and a leading authority in obesity and obesity clinical trials.

Serving as the principal investigator.

Dosing has commenced and the planned interim analysis to assess changes in body weight.

After 24 weeks of treatment is expected to readout in the fourth quarter of 2022.

Vipin Garg: In addition, a double-blind placebo control. 12-week extension of the NAFLD trial has been initiated, with an expected data readout on weight loss at 24 weeks in the fourth quarter of 2022. We believe that the 24-week weight loss readout from the NAFLD Extension Trial will provide a valuable read-through to the Phase II Momentum Obesity Trial. A 12-week trial to characterize the effects of Pemvidutide on glucose control in diabetic subjects with overweight and obesity is also ongoing.

Enrollment in the phase one b non alcoholic fatty liver disease or <unk> trial has been completed and data and data readouts for weight loss and liver fat reduction at 12 weeks of treatment.

I'd expect that in the third quarter of 2022.

In addition, a double blind placebo controlled trial.

Loud week extension of the National Deep trial has been initiated with.

With an expected data readout on weight loss at 24 weeks in the fourth quarter of 2022.

We believe that the 24 week weight loss readout from the <unk> extension trial will provide a valuable read through to the phase II momentum obesity trial.

Yes.

At 12 week drive to characterize effects of Penn, we do tied on glucose control in diabetic subjects with overweight and obesity is also ongoing.

Vipin Garg: This trial will further expand on the findings from our Phase I trial in which decreased insulin resistance and maintenance of glucose control were observed in an obese and overweight patient population that included subjects with prediabetes. Given the increasing competitive obesity space, it is important to highlight the potential differentiating features of PEMBEDUTIDE.

This trial will further expand on the findings from our phase one trial in which decreased insulin resistance and maintenance of glucose control were observed in an obese and overweight patient population that included subjects with pre diabetes.

Given the increasing competitive obesity space. It is important to highlight the potential differentiating features F&B do died.

First we believe we'll be able to achieve weight loss comparable to the results of pediatric surgery.

Vipin Garg: We believe we'll be able to achieve weight loss comparable to the results of periatric surgery, confirming the benefit of adding glucagon agonism to GLP-1 monotherapy, based on more than 10% weight loss after only 12 weeks. We expect the level of weight loss to be greater, and more rapid than other agents in development. Increasing Patient Satisfaction with Treatment.

Confirming the benefit of adding glucagon agonism DLP one monotherapy.

Based on more than 10% weight loss after only 12 weeks.

We expect the level of net loss to be greater.

And more rapid than other agents in development, increasing patient satisfaction with treatment.

Vipin Garg: In addition, we believe that the absence of dose titration will represent a major advantage in the minds of prescribers, simplifying patient management in the first months of therapy, and finally. We believe that the robust reduction of serum lipids observed in our phase one study could translate into cardiovascular benefit with long-term use, further increasing the value proposition of PAMI-DUTA-I treatment. I want to emphasize that our focus continues to be on obesity as the lead indication for PEMV2 type.

In addition, we believe that the absence of dose titration will represent a major advantage in the minds of prescribers simplifying patient management in the first months of therapy.

And finally.

We believe that the robust reduction of serum lipid <unk> observed in our phase one study could translate into cardiovascular benefit with long term use further increasing the value proposition of family do type treatment.

I want to emphasize that our focus continues to be on obesity as the lead indication for <unk>, we do tight.

Vipin Garg: While we believe that our ongoing NAFLD trial will deliver the best liver fat reduction data in clinical trials to date, and adds significant value to Pembidu Tide. We are not planning to initiate a 52-week biopsy-driven NAST trial at the current time. We believe this decision will create additional flexibility in the development of obesity indication without forfeiting the value of panvidutide in the NASH indication, and puts us in a good position to evaluate various strategic options for the continued development of PEMDiDUTI. The findings of our preclinical studies in the Gubra mouse model were published last month.

While we believe that our ongoing national deep trial.

We will deliver the best liver fat reduction data and clinical trials to date.

And add significant value to ban the due date.

We are not planning to initiate a 52 week biopsy proven Nash trial at the current time.

We believe this decision will create additional flexibility in the development of obesity indication.

Without for fitting the value when we do died in the Nash indication.

And puts us in a good position.

Evaluate various strategic options for the continued development of <unk> died.

The findings of our preclinical studies in the <unk> Mouse model were published last month.

Vipin Garg: And we are excited about the clinical data that we have generated, which we plan to present at international meetings throughout this year. We are pleased to announce that PEMBEDUTA abstracts have been accepted as oral presentations, at the 5th Global MASH Congress, the 82nd Annual Meeting of American Diabetes Association, and the 2022 meeting of European Association for the Study of the Liver. We hope to announce the publication of these study results in peer-reviewed journals in the near future, turning to happy self.

And we are excited about the clinical data that we have generated which we plan to present at international meetings without throughout this year.

We are pleased to announce that <unk> abstracts have been accepted as oral presentations.

At the fifth Global Nash Congress.

The 80 <unk> annual meeting of the American Diabetes Association.

And the 2022 meeting of European Association for the study of the liver.

We hope to announce the publication of these study results in peer reviewed general journals in the near future.

Turning to Hep B cell.

Vipin Garg: Enrollment in our Phase II clinical trial in chronic hepatitis B subjects is ongoing, with an expected study readout in the first half of 2023. We are excited about the progress of panbidutide and hepticell and the results of ongoing trials.

And <unk> in our phase II clinical trial in chronic hepatitis b subjects is ongoing with.

We then expected study readout in the first half of 2023.

We are excited about the progress of <unk> and the results of ongoing trials.

Vipin Garg: We expect 2022 to be an important year for Altimmune, with three major readouts representing potential significant value drivers for the company. With that, I'll now turn the call over to our Chief Medical Officer, Dr. Scott Harris, to discuss our data and clinical plans. Scott?

We expect 2022 to be an important year for <unk>.

With three major readouts, representing potential significant value drivers for the company.

With that I'll now turn the call over to our Chief Medical Officer, Dr. Scott <unk> to discuss our data and clinical plans and Scott.

Scott Harris: Thank you, Vipin, and good morning, everyone. Let me talk about the Phase 2 Momentum Trial of Pemvidutide in obesity. We expect this trial will enroll approximately 320 non-diabetic subjects with either obesity or overweight with at least one obesity-related complication. Subjects will be randomized one-to-one-to-one-to-one to receive either 1.2 mg, 1.8 mg, 2.4 mg penvadutide or placebo administered weekly for 48 weeks.

Thank you Vivian and good morning, everyone.

First let me talk about the phase III momentum trial of <unk> in obesity.

Scott Harris: The primary endpoint of the MOMENTUM trial is the relative 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 Aroni from Weill Cornell Medical College, 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.

We expect this trial will enroll approximately 320, non diabetic subjects with us either obesity or overweight with at least one obesity related complications.

Subjects will be randomized one to one to one to one to receive either one two milligrams. One eight milligrams two four milligrams of <unk> or placebo administered weekly for 48 weeks.

The primary endpoint of the momentum trial is the relative percent change in body weight and 48 weeks compared to baseline.

With additional readouts, including metabolic and liver lipid profiles cardiovascular measures in glucose homeostasis.

Dr Lu, earning from Wild Cornell Medical College, 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.

Scott Harris: As Vipin mentioned, we completed enrollment in our Phase 1B-Nafl-D clinical trial of Pembidutide and expect a data readout in the third quarter of 2022. This trial is designed to assess the effects of pemvidutide on liver fat and body weight in subjects with obesity or overweight with NAFLD, defined as a 10% or greater liver fat content as measured by MRI-PDFF. Non-diabetic and diabetic subjects were randomized 1 to 1 to 1 to 1 to Penfidutide 1.2 mg, 1.8 mg, 2.4 mg or placebo over 12 weeks of treatment.

As Vipin mentioned, we completed enrollment in our phase <unk> clinical trial of <unk> and expect a data readout in the third quarter of 2022.

This trial is designed to assess the effects of <unk> on liver fat and body weight in subjects with obesity are overweight with naphtha D defined as a 10% or greater liver content liver fat content as measured by MRI <unk>.

Non diabetic in diabetic subjects were randomized one to one to one to one to <unk> $1 2 million grams, one eight milligrams, two four milligrams or placebo over 12 weeks of treatment.

Scott Harris: 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 NAPLD and NASH. Based on the results of our phase one clinical trial, we expect to achieve a robust reduction in liver fat content and again show a significant weight loss in subjects after 12 weeks of treatment.

The primary endpoint of this trial is the reduction in liver fat by MRI PFF, 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 naphtha.

<unk>.

Based on the results of our phase one clinical trial, we expect to achieve a robust reduction in liver fat content and again show a significant weight loss and subjects after 12 weeks of treatment.

Scott Harris: 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 Pembedutide to the weight loss achieved by Semaglutide and Terzapatide at 24 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 <unk>.

So the weight loss achieved some are glued tied in tours appetite at 24 weeks of treatment.

Scott Harris: We expect data readout on the 24-week weight loss endpoint in the fourth quarter of 2022. Later this year, we also expect to have the results of two additional Phase I studies to evaluate the effects of penta-dutide on glucose control in people with diabetes and its potential for drug-drug interactions. We are rapidly building the PEMPA-DUTAI clinical development program and expect to have accrued safety data in over 200 subjects receiving one or more doses of PEMPA-DUTAI in clinical trials by the fourth quarter of 2022.

We expect data readout on the 24 week weight loss endpoint in the fourth quarter of 2022.

Later this year. We also expect to have the results of two additional phase one studies to evaluate the effects of <unk> on glucose control in people with diabetes and its potential for drug drug interactions.

We are rapidly building the <unk> clinical development program and expect to have a crude safety data and over 200 subjects, receiving one or more doses of <unk> in clinical trials by the fourth quarter of 2022.

Scott Harris: I want to highlight the robust effects of penta-dutide on serum lipids that was demonstrated in our first in-human clinical trial, which could have important implications for cardiovascular risk. It's well established that NASH and NAPLD patients come most often to the cardiovascular comorbidities associated with obesity, which include myocardial infarction, stroke, and heart failure. Panfidutide treatment for 12 weeks resulted in robust reductions of total cholesterol, LDL cholesterol, and triglyceride, elevated levels of which are associated with increased risk for cardiovascular disease.

I want to highlight the robust effects of attempt to do tired on serum lipids that was demonstrated in our first in human clinical trial, which could have important implications for cardiovascular risk.

It's well established that Nash and Napa <unk> patients come most often to the cardiovascular comorbidities associated with obesity, which include myocardial infarction stroke and heart failure.

Panther <unk> treatment for 12 weeks, we wrote resulted in robust reductions of total cholesterol LDL cholesterol and triglyceride laid elevated levels of which are associated with increased risk for cardiovascular disease.

Scott Harris: We will be presenting these findings in an oral presentation at the American Diabetes Association meeting this coming June. We are also making continued progress in the enrollment of our Phase II clinical trial in patients with an active chronic hepatitis B, and expect to read out the results of this trial in the first half of 2023. Recall that the 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. I will now hand the call over to Rich Eisenstadt to give us an update on our first quarter financial results. Thank you, Scott, and good morning again, everyone.

We will be presenting these findings in an oral presentation at the American Diabetes Association meeting this coming June .

We are also making continued progress in the enrollment of our phase II clinical trial in patients with an active chronic hepatitis b.

And expect to read out the results of this trial in the first half.

Of 2023.

Recall that the virologic effects of Hep T cell are being evaluated in chronically infected patients to enable the combination of <unk> T cell with novel direct acting Antivirals as part of combination therapy for chronic hepatitis b.

I will now hand, the call over to Ritch Allison start to give us an update on our first quarter financial results rich.

Thank you Scott and good morning again, everyone.

Rich Eisenstadt: For today's call, I'll be providing a brief update on Altimume's first quarter 2022 financial and operating results. More comprehensive information will be available in our Form 10-Q to be filed with the SEC later today. I also will provide some guidance on our expenses for 2022. Altimmune ended the first quarter of 2022 with approximately $180 million cash and cash equivalents compared to $190.3 million at the end of 2021. Turning to the income statement, revenue was minimal in the first quarter of 2022 compared to $800,000 in the same period in 2021.

For today's call I'll be providing a brief update on <unk> first quarter 2022 financial and operating results.

Our comprehensive information will be available in our Form 10-Q to be filed with the SEC later today.

I also will provide some guidance on our expenses for 2022.

<unk> ended the first quarter of 2022 with approximately $180 million of cash and cash equivalents compared to $193 million at the end of 2021.

Turning to the income statement revenue was minimal in the first quarter of 2022 compared to $800000 in the same period in 2021.

Rich Eisenstadt: Our change in revenue for the quarter is primarily due to discontinuation of development activities for our T-COVID and Asia Shield programs and will be de minimis going forward. Research and development expenses were $15.1 million in the first quarter of 2022, compared to $11.9 million in the same period in 2021. The expenses for the quarter ended March 31st, 2022, included $10.8 million in direct costs related to the development activities for pemphidutide and $2.5 million in direct costs related to development activities for hepti cell.

Our change in revenue for the quarter was primarily due to discontinuation of development activities for our T. Covid in Asia shale programs and albeit the amendments going forward.

Research and development expenses were $15 $1 million in the first quarter of 2022 compared to $11 9 million in the same period in 2021.

The expenses for the quarter ended March 31, 2022 included $10 $8 million and direct costs related to the development activities for <unk> and $2 $5 million and direct costs related to development activities for <unk> T cell.

Rich Eisenstadt: 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 the Phase 2 trial, Pembidutide, which occurred in April, subsequent to quarter end, and will be reflected in the Q2 balance sheet. General and administrative expenses were $4.4 million in the first quarter of 2022 as compared to $3.8 million in the same period in 2021. The year-over-year change was primarily attributable to increased stock compensation expense.

As a reminder, we will have one less development milestone of $3 million payable.

Payable in common shares of the company within 60 days following dosing of the first patient in the phase III trial, <unk>, which occurred in April subsequent to quarter end and will be reflected in the Q2 balance sheet.

General and administrative expenses were $4 $4 million in the first quarter of 2022 as compared to $3 8 million in the same period in 2021.

The year over year change was primarily attributable to increased stock compensation expense.

Rich Eisenstadt: Net loss for the three months ended March 31, 2022, was $19.4 million, or 44 cents net loss per share, compared to $14.9 million, or 38 cents net loss per share for the first quarter of 2021. We currently estimate that our research and development expenses for full year 2022, including the $15.1 million reported in Q1, will be approximately $75 million. GNA expenses for the full year 2022 are anticipated to be approximately $19 million. Approximately $8.5 million of these operating costs are for non-cash expenses, including stock compensation and depreciation and amortization.

Net loss for the three months ended March 31, 2022 was $19 4 million or <unk> 44, net loss per share compared to $14 9 million or <unk> 38, net loss per share for the first quarter of 2021.

We currently estimate that our research and development expenses for full year 2022, including the $15 1 million reported in the Q1 will be approximately $75 million.

G&A expenses for the full year 2022 are anticipated to be approximately $19 million.

Approximately $8 $5 million of these operating costs are for noncash expenses, including stock compensation and depreciation and amortization.

Rich Eisenstadt: With the added financial flexibility afforded through the delay and initiation of a Phase II trial, PEMPA do tied in that. Our existing cash not only fully funds us through the NAPLD and 48-Week Momentum Obesity Trial data set. But we currently estimate that our cash is sufficient to allow us to operate well into 2024. I will now turn it back over to Vipin for his closing remarks. Vipin.

With the added financial flexibility afforded to the delay in initiation of a phase III trial empathy tightened bash, our existing cash not only fully funds us through it.

L D.

48 week momentum obesity trial datasets, but we currently estimate that our cash is sufficient to allow us to operate well into 2024.

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

Vipin Garg: 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? Thank you, sir. If you would like to ask a question, please press star 1 on your touchtone phone. You may remove yourself from the queue at any time by pressing star 2.

Thank you rich.

Operator that concludes our formal remarks, and we would like to open the line to take questions would you. Please instruct the audience on the Q&A procedure.

Thank you Sir if you would like to ask a question. Please press star one on your Touchtone phone.

You may remove yourself from the queue at any time by pressing star two.

Operator: Again, that is star 1 to ask a question. We will pause for just a moment to allow questions to queue. Thank you. Our first question will come from Seamus Fernandez with Guggenheim. Thanks, guys. And, you know, congrats on the quarter. Obviously, good management and execution around the expenses.

Again that is star one to ask a question, we'll pause for just a moment to allow questions to queue.

Thank you our first question will come from Seamus Fernandez with Guggenheim.

Thanks, guys.

Congrats on the quarter, obviously, good management and execution.

Seamus Fernandez: You know, can you help us understand a little bit, you know, obviously, it's great to see the NASH study, you know, really more incorporated into potential strategic options going forward. But maybe you could just give us a little bit of clarity along those lines. You know, how far into 2024 do you think that the cash would likely take us?

Around the expenses.

Can you help us understand a little bit.

Obviously, it's great to see the Nash study.

Really more incorporated into potential strategic options going forward, but maybe you could just give us a little bit of clarity along those line.

How far into 2024 do you think that the cash would likely take us.

And just wanted to get a sense of that payment that you mentioned rich.

Seamus Fernandez: You know, and just wanted to get a sense of that payment that you mentioned, Rich. You know, just wanted to get a little bit of clarification on the number that you mentioned there that's going to be paid, I think, in the second quarter here. I just kind of missed the absolute number. I couldn't hear if it was 16 or 60, to be honest.

Just wanted to get a little bit of clarification on the on.

The number.

That you mentioned that thats going to be paid I think in the second quarter here just kind of missed the absolute number I couldnt help it was 60% or 60 to be honest.

And then the second.

Second question.

Seamus Fernandez: And then the second question, you know, is really for Scott Harris. Can you just help us understand what exactly you're looking to understand from these other phase one studies in the context of the diabetic patient population and why the company is conducting those? I think those are some important questions.

It was really for Scott Scott Harris.

Can you just help us understand what exactly.

You are looking to understand from these other phase one studies.

In the context of the diabetic patient population.

And why the company is conducting those I think those are those are some important.

Seamus Fernandez: And then just my final question, you know, Vipin, as you kind of think strategically about the market opportunity here, obviously, you've mentioned the competitive landscape. But in the context of the size of this market opportunity, you know, can you just help us better understand, you know, what you think the level of strategic interest is likely to be and when that becomes, you know, sort of a key discussion point for the company based on the data that you're bringing forward? Thanks. Thank you, Seamus.

Of important questions and then just my final question.

And as you kind of think strategically about the market opportunity here, obviously, you've mentioned the competitive landscape.

But in the context of the size of this market opportunity.

Can you just help us better understand.

What you think the level of strategic interest is likely to be and when that.

That becomes.

Sort of a key discussion point for the company.

Based on the on the data that you are bringing forward. Thanks.

Vipin Garg: Lots of questions there. We'll try to address them one by one. Let me just sort of set the stage in terms of our rationale behind the NASH delay in the NASH study, you know, the 52-week biopsy-proven, biopsy-driven study. As you know, we've got a number of studies going on that will be generating significant amount of data in terms of liver fat reduction, and we think that's going to be sufficient, sort of drive the value proposition for people to sort of draw the line and we'll also be getting data from other companies, other players in NASH space during 2022. So if we put all that together, we think we'll have enough information to convince a strategic partner the value proposition that we bring to NASH, which we think will be substantial.

Well, thank you Seamus.

Just to add what we're trying to address them one by one let me just sort of set the stage in terms of our rationale behind the Nash delay in the Nash study.

The 52 week biopsy proven biopsy driven study.

As you know we've got a number of studies going on that will be generating significant amount of data.

In terms of liver fat reduction and we think thats going to be sufficient to sort of drive the value proposition for people to sort of draw. The line and will also be getting data from other companies other players <unk> and Nash space. During 2022. So you put all that together, we think we'll have enough information to convince.

As a strategic partner.

The value proposition that we bring to Nash, which we think will be substantial.

Vipin Garg: So given that, what we want to do is focus on obesity, generate as much data as we can, and maintain financial flexibility. It's really driven by that that we've decided to essentially postpone at this point initiation of a Phase II NASH study, which as you know are very long, so we're not going to see anything out of that study until sometime in 2024, even if we start that study right now. So it was given all of those considerations, we felt we would still be able to retain the upside value of the NASH indication in our discussions, and I'm pretty sure that a strategic partner would want to pursue both obesity and NASH indications, just like other large pharma players are doing in this, in the incretin space, so there's no question that incretins will play a role in NASH treatment ultimately, just a matter of timing.

So given that what we want to do is focus on obesity generate as much data as we can and maintain financial flexibility.

And it's really driven by that that we've decided to essentially postponed at this point initiation of a phase II Nash study, which as you know are very long. So we're not going to see anything out of that study until sometime in 2020 forward. Even if we stopped that study right now so he was given all of those considerations.

We felt we would still be able to retain the upside value of the Nash indication in our discussions.

And I'm pretty sure that our strategic partner would want to pursue both to obesity and Nash indications just like other large pharma players are doing in this in the <unk> space. So Theres no question that <unk> will play a role in it.

Nash treatment ultimately in just a matter of timing. So that's the rationale that we are using with that let me just turn it over to rich to talk about the.

Vipin Garg: So that's the rationale that we're using. With that, let me just turn it over to Rich to talk about your questions about the funding and financing and how long will that last. Yeah, sure. Thanks, Vipin, and thanks for the question, Seamus. We didn't provide specific guidance on to how deep into 2024 we'll get.

Questions about the the funding and financing.

And how long will that last rich.

Yeah sure Thanks, Jeff and thanks for the question Seamus.

We didn't provide specific guidance on how deep into 2024 woke at that we believe will be sufficient we should have.

Rich Eisenstadt: We believe it will be sufficient. We should have, you know, give or take, you know, approximately a year's cash when we have the data or completion of the Momentum trial. So, I hope that helps. Of course, you know, a lot changes as time goes on, depending on what the data looks like and additional studies that you may or may not need to do. But it is sufficient to gather all the data, get to the FDA and have discussions, and then we believe engage in these potential strategic discussions. Regarding the payout for Spitfire, the amount is $3 million.

Give or take approximately a year's cash.

When we have the data.

Our completion of the momentum trial.

So I hope that that helps of course, a lot of changes as time goes on.

Pending on what the data looks like and additional studies that you may or may not need to do.

It is sufficient to gather all the data to the FDA and have discussions and then we believe engaged in these potential strategic discussions.

Rich Eisenstadt: I'm sorry for the confusion on that. It gets paid within 60 days following the achievement of the milestone, and it will be paid in shares, Seamus. There's a preset formula, and the formula indicates that it will likely result in the issuance of approximately 850,000 common shares of the company. Perfect. That's super helpful. And then just the last question on the diabetes patients, and maybe just an update, if you guys are willing, just to kind of provide a general color on how the obesity study, how the momentum study is recruiting so far, and how you're feeling in terms of that tracking to providing an interim look, whether it be at the full patient population or part of the patient population in the fourth quarter.

Regarding the.

The payout for the acquire the amount is $3 million I'm sorry for the confusion on that it gets paid within 60 days following the achievement of the milestone and it will be paid in shares Seamus as a preset formula.

And.

The formula indicates that it will likely result in the issuance of approximately 850000 common shares of the company.

Perfect.

Helpful. And then just the last question on the.

The diabetes patients and maybe just an update.

If you guys are willing just to kind of provide us general color on how the.

Obesity study how.

How the momentum study is recruiting so far and how you are feeling in terms of that tracking to providing an interim look.

Whether it be at the full patient population or part of the patient population in the.

In the fourth quarter.

Rich Eisenstadt: Thanks. Scott, do you want to take the diabetes first? Sure. Thank you, Seamus, for the question. I'll take the diabetes part first, and then I'll finish, with some comments about the momentum study. So, as you know, within the obesity population, 80% of that population does not have diabetes, and you're well aware that, What really controls blood sugar chronically in this population is the weight loss that was shown in the STEP trials.

Scott do you want to take the debt piece first sure. Thank you Seamus for the question I'll take the diabetes part first and then I'll finish.

With some comments about the momentum study.

So as you know within the obesity population, 80% of the population does not have diabetes.

And.

You are well aware that.

What really controls blood sugar chronically in this population is the weight loss that was shown in the step trials the change in hemoglobin <unk> C. At 52 weeks is predominantly driven by the weight loss. So over the long run we think that this drug will have excellent applications in diabetics.

Rich Eisenstadt: The change in hemoglobin A1c at 52 weeks is predominantly driven by the weight loss. So over the long run, we think that this drug will have excellent applications in diabetics. Also, in our phase one study, we saw no perturbations in glucose control measured by fasting blood sugar or hemoglobin A1c.

Also in our phase one study we saw no perturbations in glucose control measured by fasting blood sugar hemoglobin <unk> C and in fact as you would have expected with the weight loss that was observed we actually had a reduction of insulin resistance that bodes quite well for the results of what we're going to see in 52 weeks either in Iran.

Scott Harris: And in fact, as you would have expected with the weight loss that was observed, we actually had a reduction of insulin resistance that bodes quite well for the results of what we're going to see in 52 weeks, either in a non-diabetic population or a diabetic population. I think that we felt the obligation at this point to study the effects of pembedutide acutely on aspects of glucose control that are typically studied in more intense phase one studies, such as continuing glucose monitoring and the like. And we really couldn't do that in our current studies without making them too complicated.

Diabetic population or a diabetic population I think that we felt the obligation at this point to study the effects of <unk> acutely on aspects of glucose control that are typically studies and more intense phase one studies, such as continuing glucose monitoring in the large and we.

We couldnt do that in our current studies.

Without making them, making them too complicated so we elected to conduct our committed study and diabetics and Thats what were trying to get out of the study right now I'll answer. The second question about the momentum study and I'm happy to go back and backfill on that answer I just gave you on the obesity.

Scott Harris: So we elected to conduct a committed study in diabetics, and that's what we're trying to get out of the study right now. I'll answer the second question about the MOMENTUM study, and I'm happy to go back and backfill on that answer I just gave you on the obesity. So the MOMENTUM study is going quite well. We're very enthusiastic with enrollment.

So the amendment study is going quite well, we're very enthusiastic with enrolment. We think it's going to enroll very very quickly most of obesity studies too and we have 25 extremely enthusiastic investigators the best guidance I can give you is we'll give you an update when the enrollment in the study completes and tell you what our plans right now.

Scott Harris: We think it's going to enroll very, very quickly, like most obesity studies do. And we have 25 extremely enthusiastic investigators. The best guidance I can give you is we'll give you an update when the enrollment in the study completes and tell you what our plans right now. Right now we're optimistic that we'll have a very meaningful readout at the end of the year, and Seamus Pugliese. And to your question about strategic thinking and the process going forward, I mean, look, the whole obesity space is maturing. I think the latest data from Tres Apatite is helping. It's growing awareness. There'll be a lot of interest from multiple players in this space. That's how we see it.

All right now we're optimistic that we'll have a very meaningful readout at the end of the year.

And Seamus.

I appreciate it.

And to your question about strategic thinking and the process going forward I mean look the whole obesity space is maturing I think the latest data from does appetite is helping its growing awareness there'll be a lot of interest from multiple players in this space. That's how we see it and we are trying to do is really.

Vipin Garg: And what we're trying to do is really generate important data that would put us in the best position to do a robust transaction, partnering transaction around this asset. So a lot of the studies, we've said it many times, we're doing these studies because we think they would add value in our strategic partnering discussions. I think overall, there are multiple players out there that are going to want to play in this space, and we just want to be ready for that. Excellent. Thanks so much.

Generate important data that would put us in the best position to do a robust transaction partnering transaction around this asset so lot of the studies. We've said it many times we are doing these studies, because we think that would add value in our strategic partnering discussions I think overall.

There are multiple players out there that are going to want to play in this space and we just want to be ready for that.

Excellent. Thanks, so much I appreciate it.

Vipin Garg: Appreciate it. Thank you. Our next question will come from Yasmeen Rahimi with Piper Sandler. Good morning, team, and thank you for taking my questions. I'm going to go one by one.

Thank you. Our next question will come from Yasmin Rahimi with Piper Sandler.

Good morning team and thank you for taking my question.

Yasmeen Rahimi: Maybe a good place to start off would be, can you comment on the 1B NAFLD study, what you're seeing in regards to discontinuation rates, how many data safety monitoring committees have you had, and what your expectations are in terms of GI tolerability. So just anything safety related to the 1B that you've been previewed to during this time. Could be helpful for us, and then I have a few more.

One by one maybe a good place to start off would be.

Can you comment on that one we know folks study what youre seeing in regards to discontinuation rate how many data safety monitoring committees have you had.

And what your expectations are in terms of Gi Tolerability. So just anything safety related to the one that you have been previewed during this time could be helpful. And then I have a few more.

Scott Harris: Well, thanks for the question, Yasmeen. As you know, we continue to be blind in the study, and I can't give you data that we don't have. I will tell you that from the safety point of view, we're extremely pleased, as we've said before, with the safety profile and tolerability of the compound in that study, as well as the other studies that we're conducting right now. There is no official data monitoring committee for this study.

Well. Thanks for the question you asked I mean as you know we continue to be blinded in the study and I can I can't give you data that we we don't have.

I will tell you that from the safety point of view, we're extremely pleased as we've said before with the safety profile and Tolerability of the compound.

In that study.

As well as the other studies that we're conducting right now.

There is no official data monitoring committee for this study you wouldn't expect it with a phase one study. However, we have a safety committee.

Scott Harris: You wouldn't expect it with a phase one study. However, we have a safety committee that reviews the data from the study in a blinded fashion on a regular basis, and those meetings have not identified any issues to date consistent with what I've said before. Regarding the GI tolerability, we think it's only going to improve going forward. Remember that with phase one studies, the tolerability profile of the compound is less, less optimistic than it would be in Phase 2 and Phase 3. And the reason is, number one, there's less known about the compound at that time.

The reviews.

The data from the study in a blinded fashion on a regular basis and those meetings have not.

Identified any issues to date consistent with what I've said before.

Regarding the Gi Tolerability, we think it's only going to improve going forward.

Remember that with phase one studies, the tolerability profile of the compound.

<unk> is less.

<unk>.

Less optimistic than it would be in phase II and phase III.

And the reason is number one this less known about the compound with a time theres more.

Scott Harris: There's more heightened, there's more concern about anything that you see. Investigators are heavily attuned to asking patients questions repeatedly. Subjects are admitted to the unit for much of that time, so they're under constant surveillance, and then they come back weekly.

Heightened.

There is more concern about anything that you see investigators are heavily attuned to asking patients questions repeatedly subjects, who are admitted to the unit for much of the time. So they are under constant surveillance and then they come back weekly.

Scott Harris: That's very different from a Phase II environment, like the Momentum Study, when patients would be coming back, say, every two to four weeks and not being monitored constantly. And it was well shown in the terzepatide and semaglutide programs that when they went from Phase I to Phase II, that they had a tremendous decrease in their adverse events. We were very happy with the tolerability profile that we had with PEMBA-DUTAD in our Phase 1 program. We had no adverse event discontinuations.

That's very different from our phase II environment like the momentum study when patients will be coming back.

Every two to four weeks and not being one monitor constantly and was well shown in the tours appetite and <unk> programs that when they went from phase one to phase two.

Had a tremendous three curious in their adverse events. So we were very happy with the Tolerability profile that we had with <unk> in our phase one program. We had no adverse event discontinuation, we think it's only going to get better going forward.

Scott Harris: We think it's only going to get better going forward. Thanks, Scott. I just want to clarify on the commentary you made. One, do you get notified when a discontinuation occurs in the Manouffled Study or the Momentum Study, and have you been notified? Yeah, I mean, we are notified.

Thanks, Scott I just wanted to clarify on the commentary you made one do you get notified women discontinuation occurs and then Apple study or the momentum study and have you been notified.

Yasmeen Rahimi: I'm not, you know, free to speak on this on a specific basis other than to say that we're very happy with what we're seeing right now. And then when you made the remarks that the GI tolerability could be looking more favorable in a Phase 2 study, are you saying that the Phase 1b NATFOLK study's GI profile could be, given the protocol is more similar to the 1b OBESE data set that we have seen, or is the execution of the 1b more like the Phase 2 momentum? Could you clarify, please?

Yes, I mean, we are notified.

Free to speak on this on on a specific basis other than to say that we're very happy with what we're seeing right now.

Got it and then when you made the remark that.

Safety.

Gi Tolerability tolerability could be looking more favorable.

In our phase two study are you, saying that the phase one b naphthyl steady Gi profile could be given the protocol is more similar to that one be obese data set that we have seen.

Or is the execution of the one being more like the phase III momentum could you clarify please.

Scott Harris: Thank you. Yeah, I think that clearly, as you go from phase one to phase three, the tolerability profile of the compound improves. So one would expect, based on that, that the tolerability in a phase two might even be better than a 1b. But once you get the patients out of the phase one unit, and you know more about the compound, and you have more confidence of the investigators with what you've seen, it gets better.

I think that clearly as you go from phase one to phase III. The tolerability profile of the compound improves. So one would expect based on that that the tolerability in a phase III might even better would be better than <unk>, but once you get the patients out of the phase one unit.

More about the compound.

You have more confidence of the investigators with what <unk> seen it gets better. So we expect that the tolerability in a phase <unk> study will be better than it was in the first in human study and that it will progressively get better going forward.

Scott Harris: So we expect that the tolerability in the phase 1b study will be better than it was in the first in human study, and that it will progressively get better going forward. Thank you. And then last question, any more commentary on like, what exactly we should be expecting out of the interim? Like, what goes into your decision to decide whether you're going to pick?

Thank you and then last question any more commentary on Mike what exactly we should be expecting out of the interim like what goes into your decision to decide whether you want to pick.

Yasmeen Rahimi: you know, 20 patients per arm or 30 patients per arm. Now it's been, what, about a month and a half, two months into the study. Like, can you help us narrow down what exactly, how big the interim analysis will include? And thank you for taking my question. Yeah, happy to answer that for you, Yasmeen. As you know, we're right now in the beginning of May. We still have a long way to go with a very rapid recruitment.

All 20 patients per arm or 30 patients per arm.

Now it's been about a month and a half two months into the study like can you help us narrow down what exactly how big the interim analysis will include and thank you for taking my question yes.

Yes happy to answer that for you, yes, Ben as you know.

We're right now in the beginning of May we still have a long way to go with a very rapid recruitment, we're simply going to have to look at the data at the time that we have to do the cutoff and.

Scott Harris: We're simply going to have to look at the data at the time that we have to do the cutoff and make that decision about whether it's a complete set or if it's an incomplete set, how many patients are in it. Based on our current projections, we think that the amount of subjects included in that interim analysis, if not the complete set, will be meaningful, enough to be convincing of the data that's being seen, and that's the best guidance I can give you until we see how enrollment is going. And when do you when you make that decision?

Make that decision about whether it's a complete set or if it's an incomplete set.

How many patients are in it based on our current projections, we think that the amount of subjects included in the interim analysis, if not the complete set will be meaningful.

Enough to be convincing of the data that's being seen and Thats. The best guidance I can give you until we see how enrollment is going.

Yasmeen Rahimi: When is that time period? Is this in July then? Or at what point? Probably in July.

And when do you when do you make that decision when is that time period.

July then or at what probably mid July yes.

Scott Harris: Yeah, probably in that time frame, the middle of the year. Okay, great. Thank, You're welcome. Thank you. Our next question will come from Liisa Bayko with Evercore ISI. Hi there, how are you? Good morning, Liisa. Can you hear me?

Probably in that timeframe in the middle of the year.

Okay, great. Thank you Youre welcome.

Thank you. Our next question will come from Lisa <unk> with Evercore ISI.

Hi, there how are you.

Good morning, Lisa.

Good morning.

Liisa Bayko: Good morning. Just for I want to ask quickly for the study you're doing that does not include diabetics, the obesity study, are you just are you not at a point where you can include diabetics now? I know I know you have an earlier study. I'm just curious why not just make it kind of all comers.

I wanted to ask quickly for the study Youre doing that does not include diabetic obesity study.

I'm not at a point, where you can include diabetic now I know I know you have an earlier study curious lineup.

I'll summarize in a way.

Yes.

Scott Harris: Thanks for the question, Liisa. Well, you know, typically in obesity studies, Liisa, if you look at the STEP program, the SURPASS program, the SURMOUNT program, in these Phase II obesity studies, in Phase III, diabetics and non-diabetics are not included, and I believe that the agency would want it that way as well. So, consequently, you have to choose one or the other, and we think that the more meaningful readout is going to be in the non-diabetics.

Thanks for the question Lisa well typically in obesity studies, Lisa if you look at the step program the surpass program their <unk> program.

In these phase II obesity studies in phase III diabetic and non diabetics are not included.

And I believe that the agency would want it that way as well.

So consequently, you have to choose one or the other and we think that the more meaningful readout is going to be in the non diabetics. Obviously at some point, we do an obesity chronic study, but that phase II study right now as a non diabetics and we think that taking the lead given the precedent with step one and also surmount, one which are non diabetics adjustment.

Scott Harris: Obviously, at some point, we do an obesity chronic study, but that Phase II study right now is in non-diabetics, and we think that taking the lead, given the precedent with Step 1 and also Surmount 1, which are non-diabetics, it just makes sense that we match that by doing non-diabetics in Momentum. Yeah, the recent terzapatite data was all non-diabetics. Exactly.

That we matched up by doing non bio diabetics and momentum yes. The recent debt does appetite data was all non diabetics exact weekend, so thats pretty standard in the obesity space.

Scott Harris: So, that's pretty standard in the obesity space to not commingle them in large studies. Do you see the data as kind of your new benchmark in a way? Yeah, so, you know, we've been obviously looking at the whole landscape in obesity. And I think first of all, let me say that, It's really validating that the dual agonism approach is becoming more validated now. Clearly, we can see benefit over just pure GLP-1 approach. So, sort of the first benchmark was 15 to 20 percent of that 15 percent range.

Many of them in large studies.

Do you see the appetite data kind of your new benchmark in a way.

Yes, so we've been obviously looking at the whole landscape and obesity I think first of all let me say that.

It's really validating that the dual agonism approach is becoming more validated now we clearly we can see benefit over just pure <unk> approach so sort of the first.

Benchmark was 15% to 20% of that 15% range. We just have crossed the 20% Mark. So does that does appetite as you know has about 20% to 22% that weight loss.

Vipin Garg: We just have crossed the 20 percent mark. So, Tazepatite, as you know, has about 20 to 22 percent weight loss. And that's great because I think that the interest in multi-agonism is going to grow with this. So we now know what GLP-1 and GIP can do. The question is, what can glucagon combined with GLP-1 do? Obviously, we have some data at this point. And just to put things in perspective.

And that's great because I think that.

The interest in multi agonism, he is going to grow with this so we now know what <unk> can do the question is what can glucagon combined with <unk> one one.

Obviously, we have some data at this point and just to put things in perspective.

Vipin Garg: Atrazepatite showed about 22 percent, 20 to 22 percent after 72 weeks. We have shown 10% weight loss after just 12 weeks, one-sixth the time of Zepatite data. So we feel very comfortable that we will be able to at least meet, perhaps surpass that number as we go towards 48 weeks. So not only do we expect to be greater than Zepatite, but also much faster in terms of getting there.

<unk> showed about 22%, 20% to 22% after 72 weeks.

We have shown 10% weight loss after just 12 weeks one sixth the time.

Does that put that data so we feel very comfortable.

We will be able to at least meet perhaps a fast that number as we go towards 48 weeks. So we have not only we expect to be greater than does appetite, but also much faster in terms of getting there.

Scott Harris: In our 48-week study, we could already be approaching those numbers. So we feel very good about our prospects based on our Phase I data. Scott.

In a 48 week study, we could already be approaching those numbers. So we feel very good about our prospects based on our phase one data.

Scott and then add capital.

Scott Harris: Okay. Yeah, Liisa, I'll add to Vipin's comments that we're extremely excited by the prospect of delivering these results, without dose titration, we think this is a very, very important commercial advantage, both for patient satisfaction, patients who want to lose weight faster while they're paying for the drug, in the first five months of therapy with terzepatide and dose titrating, and also the ease that it gives physicians for prescribing who really do not want to be involved in managing complex dose titration.

Yes, Lisa.

Ill add to <unk> comments that we're extremely excited by the prospect of delivering this these results without dose titration, we think this of a.

A very very important commercial advantage, both for patient satisfaction patients who want to lose weight faster, while they are paying for the drug and the first five months of therapy with tours epitope dose titrated and also the ease that it gives physicians for prescribing, who really do not want to be involved.

And.

Managing complex dose titration as well one other thing I would point out is that our lipid profile appears to be superior to that of both tours appetite and <unk>. So you get the weight loss, it's certainly very important and it's very pleasing to people and doctors, but what you really want to do is decreased.

Scott Harris: As well, one other thing I would point out is that our lipid profile appears to be superior to that of both terzepatide and semaglutide, so you get the weight loss, it's certainly very important, and it's very pleasing to people and doctors, but what you really want to do is decrease the comorbidities, and you achieve that by, in many ways, by reducing the lipids, so the meaningful aspects of weight loss, have to be translated into lipids to reduce the cardiovascular risk, and we think we have a superior profile based on the inclusion of glucagon over the monotherapy or the dual therapy that includes GIP but not glucagon. Okay, you seem to have pretty I mean, so far looks like you're pretty rapid weight loss at the beginning. I'm assuming this is not linear, right?

Co Morbidities and you achieve that.

Many ways by reducing the lipid so the meaningful aspects of weight loss.

Have to be translated into lipids to reduce cardiovascular risk and we think we have a superior profile based on the inclusion of glucagon over the monotherapy or the dual therapy that includes TRP, but not glucagon.

Okay.

And so far it looks like you're pretty rapid weight loss at the beginning.

I'm, assuming that does not linear right.

The circuit.

Liisa Bayko: So it'll start to, probably level off is how do you think about the shape of the curve and how predictive do you think this early effect is? for more of the long term weight loss. Sure. Hey, Liisa.

Not really level off and how do you think about the shape of the curve and how predictive do you think that early.

That is.

For more of the long term.

Uh huh.

Sure Hey, Lisa This is Scott Roberts.

Scott Roberts: This is Scott Roberts. You know, when we look at the totality of the data out there, and this includes, you know, the STEP studies and the SURPASS study, Studies. You know, we see a relationship between, you know, the initial slope of the weight loss. And we're the final weight loss ends up, you know, and and so we're encouraged because of that, because right now we have the greatest rate of weight loss, you know, certainly through 12 weeks. Will that slope eventually change over a year?

When we look at the totality of the data out there and this includes the step studies and the surpass study.

Studies.

We see a relationship between the initial slope of the weight loss and where the final weight loss ends up and so we're encouraged because of that because right now we have the greatest rate of weight loss.

Through 12 weeks will that will that slope eventually change over a year I think that that's likely but if you look at the data there's a relationship there at least we believe strongly.

Scott Roberts: I think that that's likely. But if you look at the data, there's a relationship there, at least we believe strongly, that the bottom is really set by the initial rate. Interesting. It probably helps and encourages people to stay on drugs and everything, right?

At the bottom is really set by the initial rate.

Interesting it probably helps and encourages people to stay on drug and everything right.

Liisa Bayko: That's right. They're saying, well, that kind of goes to those titration and the fact that they're getting the full dose right out of the gate. And so it happens rapidly. They feel good about that.

That's right and they're saying one of that kind of goes to those titration in fact that they're getting the full dose right out of the gate and so it happens rapidly they feel good about that and then there seems to be this relationship where the nadir is really set by the initial slope.

Scott Roberts: And then there seems to be this relationship where the nadir is really set by the initial slope. Okay, interesting. And then just finally, can you kind of maybe qualify, how much are you spending on the PEP T cell program? And like, is there any sort of interim before the readout next year where you could kind of, and I'll make a go no go if you want to continue kind of spending on that program just because you know The majority of the value here from, you know, from an investor perspective is in the obesity program and hep C has just been such a tough area and, you know, Unclear, you know, commercial opportunity and it's just a difficult space. It's been difficult for people. Just wondering kind of if you can make a kind of some kind of early read and if it's even worthwhile depending on how much you're spending.

Okay. Thanks.

And then just finally can you kind of maybe quantify how much you're spending on the.

T cell program and like is there any sort of interim before the readout next year, where you could kind of.

And they'll make a go no go if you want to continue kind of spending on that program just because.

The majority of the valley here from an Investor perspective, and then the obesity program in Hefei assistance, such as health Ariane.

No.

Unclear.

Commercial opportunity and it's just a difficult space than difficult for people.

I'm, just wondering kind of if you can make.

Kind of early read and if it's even worthwhile depending on how much you're spending on it.

Liisa Bayko: Yeah, that's a that's a good question, Liisa. And we are, you know, we track that all the time. So, you know, we think towards the end of the year, we'll be able to determine, I think main driver is going to be the rate of enrollment. It's very difficult trials to enroll, particularly in the COVID setting, because these are international studies. And COVID keeps flaring up in different parts of the world. So things shut down.

Yes, that's a good question, Lisa and we track that all the time. So we think towards the end of the year, we'll be able to determine I think main driver is going to be the rate of enrollment today difficult trials to enroll particularly in the <unk> setting because these are international studies.

And Colby keeps flaring up in different parts of the world. So things shut down so we hear you and we at this point that you can do the math.

Vipin Garg: So we we hear you. And we at this point, as you can do the math, you know, you know, most significant spend or most of the majority of the spend is on Pembedutide here. So we think there is value to finishing that study, because without that study, you really cannot make the argument about combining hep T cell with another antiviral. So we need that data. But we'll evaluate that at the end of the year. And if we need additional flexibility, clearly that's a level that we can pull at that point.

Most significant spend on most of the majority of the spend is on <unk>. Here. So we think that is valued to finishing that study because without that study really cannot.

The argument about combining <unk> with <unk>, so we need that data.

We will evaluate that at the end of the year and if we need additional flexibility clearly that's a lever that we can pull at that point.

Liisa Bayko: Okay, thank you guys. Thank you. Our next question will come from Mayank Mamtani with B. Riley Securities. Good morning, team.

Okay. Thank you guys.

Thank you our next question will come from.

Ma'am, Tommy with B Riley Securities.

Mayank Mamtani: Thanks for taking our question. So for conference data presentation this quarter, could you talk to what we should focus on in terms of understanding the differentiating attributes of PEMRI, but also, maybe specifically at ADA, what might be the data sets, you know, that weren't maybe part of Lilly's top line press release, just things that you're looking out for at ADA. And then I have a couple of follow, Scott.

Good morning, Deane. Thanks for taking our question. So for conference data presentation. This quarter could you talk to what you should focus on.

In terms of understanding the differentiating attributes of <unk>, but also <unk>.

Maybe specifically at what might be the data set.

That wound maybe by the release topline press release this.

Things that you are looking out for that and then I have a couple of follow ups.

Scott Yes.

Scott Harris: Yeah. So, Mike, thanks for the question. You know, we'd highlight the differentiating features are number one, the potential to achieve even higher levels of weight loss. With Penvadutide and the other compounds that have been studied both so far, as Scott mentioned in his reply earlier, the rate of weight loss initially lends us to believe that the final weight loss that we will achieve will be higher. We're very optimistic about that. Second, we think the absence of dose titration is extremely important, because we think that that's right there where the pen hits the prescription pad.

So Mike Thanks for the question.

We'd highlight the differentiating features are number one.

The potential to achieve even higher levels of weight loss.

With <unk> then the other compounds that have been studied so far as Scott mentioned.

His reply earlier the rate of weight loss initially lenses to believe that the final weight loss that we will achieve will be higher we're very optimistic about.

Second we think the absence of dose titration is extremely important.

Because we think that Thats right, there, where the pen hits, the prescription pad and physicians, who are going to preference prefer this.

Scott Harris: Physicians are going to prefer this, much more to regiments that they have to follow over five nights with a physician extender or some other kind of help, and in the primary care setting, when the primary care doctor has eight minutes in front of the patient, you know, to manage this is really not feasible, and it's only going to get worse. And finally, we think we differentiate strongly on lipids because the effects of GIP and GLP-1 are mediated indirectly through weight loss, and the lipids are mainly a hepatic event.

Much more to regiments that they have to follow over five months with a physician extender or some other kind of health and in the primary care setting when the primary care Doctor has eight minutes in front of the patient in order.

To manage this is really not feasible and that's only going to get worse.

And finally, we think we differentiate strongly on lipids.

The effects of <unk> and G. L. P. One are mediated indirectly through weight loss and the lipids or mainly a hepatic event and as you know we have tremendous reductions in liver fat, but that also.

Scott Harris: And as you know, we have tremendous reductions in liver fat, but that also represents the mechanism for the serum lipids, and that's why the serum lipids decrease so much. And that's the direct effects of glucagon on the liver and the lipids, which is well described in the literature.

<unk> represents the mechanism for the serum lipid so thats why the <unk> lipids decreased so much.

And thats the direct effects of glucagon on the liver and the lipids, which is well described in the literature. So we think that for lipid reduction which is.

Scott Harris: So we think that for lipid reduction, which is what... What physicians are going to focus on, they're going to see pendidutide as having superior attributes. We're seeing effects on lipids that are similar to statins and fibrates in terms of reduction in total cholesterol, LDL cholesterol, and triglycerides. With regards to ADA, obviously, there's going to be other compounds that are being presented at that time. I am expecting to see some data from Lilly and their dual and triple agonists.

Which what physicians are going to.

Focus on they're going to see <unk> as having superior attributes we're seeing effects on lipids that are similar to statin and fiber routes in terms of reduction in total cholesterol LDL cholesterol and triglycerides.

With regards to <unk>.

Obviously theres going to be other compounds that are being presented.

<unk>.

Expecting to see some data from Lilly and their dual and triple agonist, we will have to wait and see if and what they present and that will be of extreme interest as well to us, but we'll be on the podium will be presenting the results of our phase one trial, Sam Cline, who is extremely well.

Scott Harris: We'll have to wait and see if and what they present, and that will be of extreme interest as well to us, but we'll be on the podium. We'll be presenting the results of our Phase I trial, Sam Klein, who is an extremely well-known name in obesity research from WashU. We'll be presenting that, and we're really looking for a great session. Great, thanks for that color.

All known name.

<unk> research from wash U will be presenting that and we're really looking for a great session.

Scott Harris: And then now that you have some cost savings from the 52-week NASH study and you talk about this, you know, broad cardiometabolic benefit, I was just curious, maybe it's still early days, but we are hearing in creatinine therapies getting to CV outcome trials. So is that sort of part of your plan, initial discussions, and is that in any way big then, you know, as you think about the phase three trial design, you know, 2023, 2024, on? Well, thank you for the question, Mayank.

Great. Thanks for that color and then now that you have some cost savings from the <unk> and you talk about the broad guidance metabolic benefits.

I was just curious maybe it's still early days, but we are getting.

Got it.

<unk> is that sort of.

Part of your plan.

For a discussion.

Is that in any way big boom.

As you think about that they include drive the guide granted Donaldson <unk> onwards.

Scott Harris: As you know, the CV outcome trials are trials that you do predominantly after approval, and maybe even in this space now exclusively after approval. So although our eyes are on it, it's something that's really not on the drawing board right now. At this point in time, we're looking at the surrogate markers, which should be very predictive of the outcomes, and that would be the lipids. I mean, that's your best marker of cardiovascular risk that we have.

Well. Thank you for the question, Mike as you know the CV outcome trials for trials that you do predominantly after approval and maybe even in this space now exclusively after approval.

So although our eyes are on it and it's something that's really not on the drawing board right now at this point in time, we're looking at the surrogate markers, which are should be very predictive of the outcomes and that would be the lipids and thats. Your best marker of cardiovascular risk that we have so at this stage of development in the absence of an outcomes trial, which is.

Scott Harris: So at this stage of development, in the absence of an outcomes draw, which is some time away, we'd be focusing on the lipids, and it looks really good. Yeah, the other thing I would just add, Mayank, is that once we have the phase 2 data, our focus will then shift to immediately having an end of phase 2 meeting with the FDA. So that would be another important milestone. That's really going to be our first substantive discussion with the FDA on the, you know, phase 3 plan for Pembidutide for obesity. And then just my final... Tactical question on momentum. So now you're at 25 sites.

Some time away.

We'd be focusing on lipids and it looks really good.

Yes, the other thing I would just add <unk> is that once we have the phase II data. Our focus will then shift to immediately having an end of phase II meeting with the FDA. So that was the another important milestone that's really that's really going to be our first.

Substantive discussion with the FDA on the phase III planned for <unk> for obesity.

Understood.

I know.

That's a good question.

Momentum now.

<unk> sites.

Mayank Mamtani: Any chance you're able to comment how these sites compare to other ingredient studies, you know, in terms of patient enrollment per month, how it ramps up as, you know, things progress from screening to dosing. I mean, do you see any issues of competitive enrollment or, you know, if running placebo-controlled trials is an issue in the future, and if like not having titration is critical, you know, element of enrollment, not just, you know, real-world prescriptions later on? Thanks, Mayank. There are several parts of that question. Let me try to hit on them and if I don't backfill fully.

John .

Comment how these sites compared to other <unk> studies.

In terms of patient enrollment by mind, how it ramps up as things of that from screening to dosing and then do you see any issues of competitive enrollment.

Yes.

Placebo controlled rather than issue in the future.

And if not having titration credit go.

The element of enrollment not always description may go on.

Thanks, Mike there are several parts of that question.

Question, Let me, Mike, let me try to hit on them.

Don't backfill slowly.

Scott Harris: Please ask your question again. Regarding the sites that we have in the trial, each of those sites are accomplished sites in obesity. Each have a track record, not only on enrollment, in rapid enrollment, but also retention, which is very important because we're focusing on that. There is a tremendous, and I want to emphasize this, tremendous amount of investigator enthusiasm. Investigators want to be in this space, and boy, patients really want to be in these studies.

Please ask your question again.

Regarding the sites that we have in the trial each of those sites are accomplish sites.

<unk> each have a track record not only on enrollment and rapid enrollment, but also retention, which is very important because we're focusing on that.

There is a tremendous and I want to emphasize this tremendous amount of investigator enthusiasm investigators want to be in this space and Boyd patients really want to be in these studies.

Scott Harris: There's always a challenge in these studies of keeping people in the studies, particularly the placebos. So the enthusiasm in the investigator and the enthusiasm that's given to the patient to stay in the trial, you know, with lots of attention, you know, help with their lifestyle management of the like, is extremely important. And the ability to keep the placebos in the trial are important as well. None of these sites have competitive studies and, you know, we don't think that the titration or the absence of it is any issue of anything.

There is always a challenge in these studies of keeping people in the studies, particularly the placebos. So the enthusiasm in the investigator and the enthusiasm that is given to the patient to stay in the trial.

With lots of attention.

Help with their lifestyle management of the like.

As is extremely important and the ability to keep the placebos in the trial are important as well none of these sites have competitive studies.

And.

We don't think that the titration or the absence of it is any issue if anything it's a plus because patients are looking forward to more rapid weight loss when they come into the program and that's why they're coming in as the potential for more rapid weight loss and the greater weight loss.

Mayank Mamtani: It's a plus because patients are looking forward to more rapid weight loss when they come into the program. And that's why they're coming in is the potential for the more rapid weight loss and the greater weight loss. I understood. Thanks for taking our questions. Sure.

Understood. Thanks for taking my questions.

Sure.

John Wollenden: Thank you. Our next question will come from John Wollenden with JMP Security. Hey, thanks for taking the question and congrats on the progress. I guess I had a high-level question on the decision to focus on obesity, which we appreciate, but also, you know, understanding the opportunity in NAFL. Autism, You know, how Penvey could be used in NASH if you're out there in obesity as well. Yeah, no, that's a good question, Jonathan.

Thank you. Our next question will come from Jon Windham with JMP.

Securities.

Hey, Thanks for taking the question and congrats on the progress.

I guess Ed.

High level question on the decision to focus on obesity, which we appreciate but also understanding the opportunity in Nashville.

Think means more on your hands or someone else's.

Do you have these discussions with strategics. If you are successful in obesity won't bet pardon the pun to eat into a novel opportunity.

Wondering how someone else would think of.

How <unk> could be used in Nash, if youre out there in obesity as well.

Yes, no thats a good question Jonathan.

Vipin Garg: Let me just say this, that we've always said that the path to treating NASH is through obesity. So if you look at other players that are working in GLP-1 space or GLP-1, you know, GIP space as well, they're all following both obesity and NASH. We think the data that we have generated so far on FLD speaks for itself and the data that we will generate will be sufficient to connect the dots between obesity and NASH.

Let me just say this that and we've always said that the path to treating Nash is through their obesity.

So if you look at other players that are working in <unk> space of <unk>.

Gi space as well they are all following both obesity and Nash, we think the data that we've generated so far on <unk> speaks for itself and the data that we will generate will be sufficient to do connect the dots between obesity and Nash so just pursuing obesity.

Vipin Garg: So just pursuing obesity doesn't exclude you from pursuing NASH. So whoever we partner with, ultimately we think they would value NASH in addition to the obesity indication. And really that would be the ideal way for us to proceed with both those indications in parallel. By the way, we will be ready to execute a Phase II NASH study as soon as possible. So we're making all the preparations. We're not sort of putting the pen down.

Doesn't exclude you from pursuing Nash so whoever we partner with ultimately we think they would value Nash. In addition to the obesity indication and really that would be the ideal way for us to proceed with both of those indications in parallel.

By the way, we will be ready to execute a phase III phase II Nash study as soon as possible. So we're making all the preparations we're not sort of putting the pen down we just not going to do undertake major expense and stop the study, but we will be ready to pull the trigger on that which we think has value. So we are preparing for all of that needs to be done.

Vipin Garg: We're just not going to undertake major expense and start the study, but we'll be ready to pull the trigger on that, which we think has value. So we are preparing for all that needs to be done in order to start that study as quickly as possible. Got it. And I guess to that, and Rich, I kind of missed in the prepared remarks the 2022 guidance. I was hoping you could run through that one more time.

In order to start that study as quickly as possible.

Got it.

To that end rich I kind of missed in the prepared remarks. The 2022 guidance I was hoping you could run through that one more time.

Vipin Garg: Sure, I'd just relegate the two operating cost guidance, Jonathan, so R&D expenses for the year are projected to be about $75 million for the full year, so that's inclusive of the $15 million we spent in Q1, and then GNA is around 19 million dollars in expense, and of all that expense about eight and a half million of that is non-cash.

Sure.

The.

Just really get to operating cost guidance, Jonathan So R&D expenses for the year are projected to be about $75 million.

For the full year. So that's inclusive of the $15 million, we spent in Q1.

And then G&A is around $19 million in expense.

Of all of that expense about $8 5 million of that is noncash.

Rich Eisenstadt: Very helpful. Thanks again. Thank you. Our next question will come from Patrick Trucchio with HC Rainwhite. Good morning, team. This is Jason Owen for Patrick.

Very helpful. Thanks again.

Mhm.

Thank you. Our next question will come from Patrick <unk> with H C. Wainwright.

Patrick Trucchio: And so I have a couple questions on the hep T cell program. So the first one is, what do you what do you view as the ideal antiviral to combine with hep T cell? And what is the current status of potential collaboration on hep T cell? And then I have two follow up questions. Yeah, Scott. Yeah, hey, Patrick.

Good morning team this is Jason on for Patrick.

I have a couple of questions on the Hep T cell program.

So the first one is what do you what do you view as the ideal anti Virals combined with <unk> T cell and what is the current status of the potential collaboration I'll have T cell and then I'll have two follow up questions after that.

Yes.

Yes, Scott, Yes, Hey, Patrick I think that from a combination standpoint, certainly agents that knock down surface antigen are the most likely candidates I think that we look towards the the RNA AI type of inhibitors. Those are those are the natural select.

Scott Harris: You know, I think that, you know, from a combination standpoint, certainly agents that knock down surface antigen are the most likely candidates. I think that we look towards the RNAi type of inhibitors. Those are the natural selection.

Scott Harris: There are others that are out there, whether the other nucleic acid approaches. The capsids may have some use, but I think we're really focused on significant knock down of surface antigen, creating a window, a better opportunity then for a hefty cell to go in and activate those T cells. Okay, great. So just kind of, so to kind of look forward to the data readout for the first half, are we also basically anticipating for clearance of surface antigen initial data set?

There are others that are out there whether that other nucleic acid approaches.

<unk> may have some use but I think we're really focused on significant knockdown of surface antigen, creating a window a better opportunity than four for hefty sell to go in and activate those T cells.

Okay, great. So just kind of so to kind of look forward to the data readout first half are real so basically anticipating for clearance of surface Amgen the initial dataset.

Scott Harris: Yes, and I think in terms of your question about partnering status, that kind of goes hand-in-hand. We've got initial discussions with folks pending the data, so it's really a question of who do we combine with, and it's for them as well as for us, which is the best combination, and that would only be sort of determined after we have the data. Okay, great. That's really helpful to know.

Yes, and I think in terms of your question about partnering status that kind of goes hand in hand, we've got initial discussion with folks.

Pending the data so it's really a question of who do we combine with them for them as well as for US, which is the best combination and that would only be sort of determined after the after we have the data.

Patrick Trucchio: And then the kind of last question, Hepti, so will we have any functional cure rate in the initial data or will we wait for another six months to fully assess? And what rate of functional cure would you anticipate in this trial? Scott.

Okay great.

It is now and then kind of last question on Hep C. So when we have any functional cure rate and the initial data or will we wait for another six months to fully assess.

And what rate of functional cure would you anticipate in this trial.

Scott, Yes. The trial is really not set up to look at functional cure. This is meant to look at.

Scott Harris: Yeah, the trial's really not set up to look at functional cure. This is meant to look at virological endpoint. We think that that's the data we need to take the next important step in the program. So it's really not focused on functional cure. Certainly we'll be looking for that. Would not, you know.

<unk> logical endpoint, we think that thats the data we need to take the next important step in the program. So it's really not focused on functional cures certainly will be looking for that would not.

Sure.

Scott Harris: Go beyond that, again, the study is focused on the neurological endpoints, validating the approach and setting us up then for a combination study that I think everybody who's in this area understands is really going to be the successful path forward. Hi, great, thank you so much. Thank you. It appears we have no further questions at this time.

Go beyond that again.

Study is focused on the very logical endpoints.

Validating the approach and and setting US up then for a combination study that I think everybody who is in this area understands is really going to be the successful path forward.

Operator: I would now like to turn the program back over to our presenters for any additional or closing remarks. Yes, 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 nice day. Thank you, ladies and gentlemen. This concludes today's event. You may now disconnect.

Alright, great. Thank you so much.

Thank you. It appears we have no further questions at this time I would now like to turn the program back over to our presenters for any additional or closing remarks.

Yes. 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 nice day.

Thank you ladies and gentlemen. This concludes today's event you may now disconnect.