Q1 2024 Altimmune Inc Earnings Call
Operator: Good morning, ladies and gentlemen, and welcome to Altimmune Inc.'s first quarter 2024 financial results conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. As a reminder, this call is being recorded. I would now like to introduce your host for today's conference, Rich Eisenstadt, Chief Financial Officer of Altimmune. Rich, you may begin.
Okay.
Speaker Change: Good day, ladies and gentlemen, and welcome to alter immune Inc. First quarter 2024 financial results Conference call. At this time, all participants are in a listen only mode. After.
Speaker Change: After the speaker's presentation, there will be a question and answer session.
Speaker Change: To ask a question during the session you will need to press star one one on your telephone.
Speaker Change: We'll then hear an automated message advising your hand is raised to withdraw your question. Please press star one one again.
Speaker Change: As a reminder, this call is being recorded.
Speaker Change: I would now like to introduce your host for today's conference Rich Eisenstadt, Chief Financial Officer of Ultra immune Rich you may begin.
Richard I. Eisenstadt: Thank you, Gigi, and good morning, everyone. Thank you for participating in Altimmune's first quarter 2024 Financial Results and Business Update conference call. Members of Altimmune's team joining me on the call today are Vipin Garg, our Chief Executive Officer; Scott Harris, our Chief Scientific Officer; Scott Roberts is our chief scientific officer, and Scott Harris is our chief medical officer.
Richard I. Eisenstadt: Thank you Gigi and good morning, everyone. Thank you for participating in <unk> first quarter 2024 financial results and business update conference call members of Ultimate team joining me on the call today are Pip and guard, our Chief Executive Officer, Scott Harris, our Chief Scientific Officer.
Richard I. Eisenstadt: Scot Roberts, our Chief Scientific Officer, and Scott Harris, our Chief Medical Officer.
Richard I. Eisenstadt: Following the prepared remarks from Vipin, Scott, Harris, and myself, we will hold a question and answer session. A press release with our first quarter 2024 financial results was issued this morning and can be found in the investor relations section of the company's website. Before we begin, I'd like to remind everyone that remarks about future expectations, plans, and prospects constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995, with a caution that these forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those indicated.
Richard I. Eisenstadt: Following the prepared remarks from Scott Harris and myself.
Richard I. Eisenstadt: A question and answer session a press release with our first quarter 2024 financial results was issued this morning and can be found on the Investor Relations section of the company's website.
Richard I. Eisenstadt: For discussion of some of the risks and factors that could affect the company's future results and operations, please see the risk factors and other cautionary statements contained in the company's filings with the SEC. I'll also direct you to read the forward-looking statement disclaimer in our 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 9th, 2024, 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.
Richard I. Eisenstadt: Before we begin I'd 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 automated.
Richard I. Eisenstadt: <unk> cautions that these forward looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those indicated for a discussion of some of the risks and factors that could affect the company's future results and operations. Please see the risk factors and other cautionary statements contained in the Companys filings with the SEC.
Richard I. Eisenstadt: <unk>.
Richard I. Eisenstadt: I would also direct you to read the forward looking statement disclaimer in our press release issued this morning, and now available on our website.
Richard I. Eisenstadt: Any statements made on this conference call speak only as of today's date Thursday May nine 2024, 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.
Richard I. Eisenstadt: As a reminder, this conference call is being recorded and will be available for audio replay on Altamune's website. With that, I will now turn the call over to Dr. Vipin Garg, Chief Executive Officer of Altamune.
Speaker Change: For audio replay on our website with that I will now turn the call over to Dr. Pepper Garg, Chief Executive Officer of Altamira Vipin.
Vipin Garg: Thanks, Rich. Good morning, everyone. And once again, thank you for joining us for our first quarter corporate update. On our last call, I shared our excitement about our accomplishments in 2023 with respect to the advancement of Pembidutide in the obesity and MASH indications that we are currently pursuing. We remain optimistic about the potential of our differentiated GLP-1-glucagon dual receptor agonist to contribute to the treatment of these two important diseases as we continue working towards our next milestones in each of these programs.
Speaker Change: Thanks, Rich and good morning, everyone and once again, thank you for joining us for our first quarter corporate update.
Speaker Change: On our last call I shared our excitement about our accomplishments in 2023.
Speaker Change: With respect to the advancement of <unk> died in the obesity and mash indications that we are currently pursuing.
Speaker Change: We remain optimistic about the potential of our differentiated GOP, one glucagon dual receptor agonist to continue to contribute to the treatment of these two important diseases.
Speaker Change: We continue working towards our next milestones in each of these programs.
Vipin Garg: Looking First at Obesity. The body composition data from the Phase II Momentum Trial we reported at the end of March demonstrated that 74.5% of weight loss came from body fat, and only 25.5% of weight loss came from lean mass in patients taking Pembidutide. This is comparable to effects associated with diet and exercise based on historical data.
Speaker Change: Looking first at obesity.
Speaker Change: Body composition data from the phase III momentum trial be reported at the end of March demonstrated that 74, 5% of weight loss came from body fat and only 25, 5% of weight loss came from lean mass in patients taking <unk>.
Speaker Change: This is comparable to effects associated with diet and exercise based on historical data.
Vipin Garg: This degree of lean mass preservation, together with the significant overall weight loss and robust reductions in liver fat and serum lipids observed in each of our prior clinical trials, could position Pembidutide as a best-in-class therapy for individuals with obesity and dyslipidemia or excess liver fat. These impressive results will be part of a comprehensive package of clinical and preclinical data that we plan to present to the FDA at our end of Phase 2 meeting, which we expect will be held late in the third quarter of 2024.
Speaker Change: This degree of lean mass preservation together with the significant overall weight loss and robust reductions in liver fat and serum lipids observed in each of our prior clinical trials.
Speaker Change: Good positioned <unk> as the best in class therapy for individuals with obesity, dyslipidemia or excess liver fat.
Speaker Change: These impressive results will be part of a comprehensive package of clinical and preclinical data that we plan to present to the FDA at our end of Phase II meeting, which we expect will be half late in the third quarter of 2024.
Vipin Garg: We look forward to this meeting, which will help guide the design and conduct of our Phase III Registrational Program for Pambidu Tide in Obesity. Turning to MASH, we are continuing to enroll patients in the IMPACT study, a phase 2b biopsy-driven trial evaluating two dosages of pambidutide against placebo in approximately 190 subjects. Top-line results are expected in the first quarter of 2025. Pembidutide is poised to be the first intratin-based therapeutic candidate to read out on a biopsy-based endpoint in MASH after just 24 weeks of treatment, and this is a reflection of our confidence in the ability of ambidextrous to treat the Liver Inflammation and Fibrosis that Characterizes MASH.
Speaker Change: We look forward to this meeting with the which.
Speaker Change: Which will help guide the design and conduct of our phase III Registrational program for <unk> died in obesity.
Speaker Change: Turning to mash.
Speaker Change: We're continuing to enroll patients in the impact study.
Speaker Change: Phase two be biopsy, driven trial evaluating two doses of <unk> against placebo in approximately 190 subjects.
Speaker Change: Top line results expected in the first quarter of 2025.
Speaker Change: When we do that is poised to be the first impression based therapeutic candidate to readout on a biopsy based endpoint in mass after just 24 weeks of treatment.
Speaker Change: As a reflection of our confidence in the ability of MDU type III.
Speaker Change: The liver inflammation and fibrosis that Characterises mash.
Vipin Garg: We believe that this data is positive, could give PEMI-DUTIDE a meaningful advantage over other impregnum-based candidates being studied in MASH, and could further strengthen our competitive position as we enter late-stage development. As you are all aware, our long-term goal remains to partner PAM with Utah, and we are firmly committed to finding a partner with the ability to maximize the near and long-term value of the program for Ultimune and our shareholders and who recognizes the significant potential of our candidate in obesity and MASH as well as other potential indications.
Speaker Change: We believe that these data if positive could give <unk> tied a meaningful advantage over other <unk> based candidates candidates being studied in mass and further strengthen our competitive position as we enter late stage development.
Speaker Change: As you are all aware.
Speaker Change: Our long term goal remains to partner <unk> die.
Speaker Change: And we are firmly committed to finding a partner with the ability to maximize the near and long term value of the program for <unk> and our shareholders.
Speaker Change: And who recognizes the significant potential of our candidates.
Speaker Change: BCP in mass as well as other potential indications.
Vipin Garg: In parallel with these ongoing partnering efforts and the continued advancement of Pambidu Tide for NASH, we are taking additional steps to further leverage the pipeline for drugs of the PAM-V2 type. We are not yet in a position to share specific details around additional indications or development plans beyond the two currently being studied, but we believe this is a valuable initiative. These efforts are underway, and I look forward to providing additional information as our plans take shape. With that said, I'll now turn the call over to our Chief Medical Officer, Dr. Scott Harris, to discuss our plans.
Speaker Change: In parallel with these ongoing partnering efforts and the continued advancement of <unk> type of mass we are taking additional steps to.
Speaker Change: Further elaborate the pipeline in a drug potential of family do guide.
Speaker Change: We are not yet in a position to share the specific details around additional indications our development plans beyond the two currently being studied but we believe this is a valuable initiative.
Speaker Change: These efforts are underway and I look forward to providing additional information as our plans take shape.
Scott Roberts: With that I'll now turn the call over to our Chief Medical Officer, Dr. Scott <unk> to discuss our plans Scott.
Scott Harris: As we discussed in March, the momentum data generated to date are extremely encouraging. Not only did we achieve impressive overall weight loss at 48 weeks, but the trajectory of the weight loss suggests the potential for even greater weight loss with continued treatment. Importantly, the body composition analysis showed a class-leading preservation of lean mass, with nearly 75% of the weight loss coming from fat, comparable to what is seen following diet and exercise based on historical data.
Scott: Thank you vipin.
Scott: As we discussed in March the momentum data generated to date are extremely encouraging.
Scott Roberts: Not only did we achieve impressive overall weight loss at 48 weeks, but the trajectory of the weight loss suggested the potential for even greater weight loss with continued treatment.
Scott Roberts: Importantly, the body composition analysis showed a class leading preservation of lean mass with nearly 75% of the weight loss coming from fat.
Scott Roberts: Terrible to what is seen following diet and exercise based on historical data.
Scott Harris: Moreover, the preferential loss of visceral fat over subcutaneous fat that was observed in Momentum may further differentiate Pentadutide, as it is well established that visceral fat, that is, fat associated with organs like the liver, heart, and kidney, is linked to a greater risk for cardiovascular disease than subcutaneous fat. We plan to present the full data set from the body composition analysis as well as other new data from Momentum at key medical congresses later this year. Looking at the MASH program, enrollment in the Phase IIb Impact Study continues to progress well.
Scott Roberts: Moreover, the preferential loss of visceral fat over subcutaneous fat that was observed in momentum.
Scott Roberts: Further differentiate <unk> as it is well established that visceral fat that is that associated with organs like the liver heart and kidney is linked to a greater risk for cardiovascular disease than subcutaneous fat.
Scott Roberts: We plan to present, the full dataset from the body composition analysis as well as other new data from momentum at key medical Congresses later this year.
Scott Roberts: Looking at the Max Mash program enrolment in the Phase III impact study continues to progress well.
Scott Harris: Despite FDA approval for this indication, we believe there remains a major unmet need for a drug that not only reduces MASH fibrosis but leads to clinically meaningful weight loss. We believe that weight loss is a critical component in the treatment of Nash. As excess body fat not only drives the passive physiology of MASH but its comorbidities, we also believe that weight loss alongside the treatment of the liver condition will be an important consideration for patients and physicians.
Scott Roberts: Despite our recent FDA approval in this indication we believe there remains a major unmet need for a drug that not only reduces mashed fibrosis.
Scott Roberts: Lead to clinically meaningful weight loss, we believe that weight loss is a critical component in the treatment of Nash as excess body fat not only drives the pathophysiology of mash, but its co morbidities. We also believe that the weight loss alongside the treatment of the liver condition.
Scott Roberts: We will be an important consideration for patients and physicians.
Scott Harris: We look forward to the top-line data readout from this trial, which we continue to expect in the first quarter of 2025. Looking more broadly at the pen-the-dew-tide story and the value proposition, Altimmune has long recognized that optionality and choice for patients will be important differentiators in the treatment of the metabolic diseases that we are pursuing. To that end, we are continuing to make progress towards our previously stated objective of developing an orally administered formulation of Penvidutide.
Scott Roberts: We look forward to the topline data readout from this trial, which we continue to expect in the first quarter of 2025.
Scott Roberts: Looking more broadly at the <unk> story and the value proposition.
Scott Roberts: <unk> has long recognized that Optionality and choice for patients will be important differentiators in the treatment of the metabolic diseases that we are pursuing.
Scott Roberts: To that end, we are continuing to make progress towards our previously stated objective of developing an early administered formulation of <unk>.
Scott Harris: If successful, these efforts could not only provide patients with a choice in how Pemvidutide is taken but also could support future life cycle management should Pemvidutide ultimately be approved. We will be presenting at important medical conferences later this year, and we will be highlighting, among other things, the robust and potentially beneficial effects that pemvidutide has on serum lipids, including triglycerides, total cholesterol, and L Recall that we recently reported on a preclinical study demonstrating that Pembutuite treatment improved cholesterol elimination through an important natural process called reverse cholesterol transport.
Scott Roberts: If successful these efforts can not only provide patients with a choice and help them to do tie. It has taken me Darko also could support future site lifecycle management should Panther do tied ultimately be approved.
Scott Roberts: We will be presenting an important medical conferences later this year and we will be highlighting among other things the robust and potentially beneficial effects that <unk> has on serum lipids, including triglycerides total cholesterol and LDL cholesterol.
Scott Roberts: Recall that we recently reported on a preclinical study demonstrating that <unk> treatment improved cholesterol elimination through an important natural process called reverse cholesterol transport.
Scott Harris: Those data and the clinical data that we will be reporting over the next several months describe changes in lipid metabolism that may ultimately be associated with decreased cardiovascular risk. We believe the type and magnitude of these lipid effects are best explained by the action of glucagon receptor agonism in PEMDU types. With that, I will now turn the call over to our Chief Financial Officer, Rich Eisenstadt, to review our financial results for the first time.
Scott Roberts: Those data.
Scott Roberts: And the clinical data that we were reporting that we will be reporting over the next several months next several months described changes in lipid metabolism that may ultimately be associated with decreased cardiovascular risks.
Scott Roberts: We believe the type and magnitude of these lipid effects are best explained by the action of glucagon receptor agonism in <unk>.
Scott Roberts: With that I will now turn the call over to our Chief Financial Officer, Rich I'll start to review our financial results for the first quarter rich. Thank you Scott and good morning again, everyone for today's call I'll be providing a brief update on all three in the first quarter 2024 financial and operating results more.
Richard I. Eisenstadt: Rich. Thank you, Scott, and good morning again, everyone.
Richard I. Eisenstadt: For today's call, I'll be providing a brief update on Altamune's first quarter 2024 financial and operating results. More comprehensive information will be available in our Form 10Q to be filed with the SEC later today. Altimmune ended the first quarter of 2024 with approximately $182.1 million of cash, cash equivalents, and short-term investments, compared to $198 million at the end of 2023. We project that our existing cash will fund us into the first half of 2026, which fully funds our impact trial and match. Turning to the income statement, revenue was negligible in the first quarter of 2024 and 2023. However, any revenue reported during such periods was for indirect rate adjustments on a government contract that we are closing out.
Richard I. Eisenstadt: Comprehensive information will be available on our Form 10-Q to be filed with the SEC later today.
Richard I. Eisenstadt: <unk> ended the first quarter of 2024 with approximately $182 $1 million of cash cash equivalents and short term investments compared to $198 million at the end of 2023, we project that our existing cash funds us into the first half of 2026, which fully funds our.
Richard I. Eisenstadt: <unk> trial and mash.
Richard I. Eisenstadt: Turning to the income statement revenue was negligible in the first quarter of 2024 and 2023.
Richard I. Eisenstadt: Any revenue reported during such periods for indirect rate adjustments on a government contract that we are closing out.
Richard I. Eisenstadt: Research and development expenses were $21.5 million in the first quarter of 2024 compared to $17.2 million in the same period in 2023. Approximately $14.5 million of this total for the first quarter of 2024 were direct expenses for the conduct of our clinical programs, including $13.5 million in direct costs related to development activities for PEMPVIDUIDE and $1 million in direct costs related to the wind-down and closing of HEPTICEL, as announced on March 27, 2024. R&D expenses in the first quarter of 2023 included $8.9 million in direct expenses associated with the development of PEMPVIDUIDE and $2.1 million in direct expenses related to HEPTICEL development activities. General and administrative expenses were $5.3 million in the first quarter of 2024 versus $4.5 million in the first quarter of 2023. The $800,000 increase is due primarily to an increase in stock compensation and other labor-related expenses.
Richard I. Eisenstadt: Research and development expenses were $21 $5 million in the first quarter of 2024 compared to $17 $2 million in the same period in 2023.
Richard I. Eisenstadt: Approximately $14 $5 million of this total for the first quarter of 2024 were direct expenses for the conduct of our clinical programs, including $13 $5 million in direct costs related to development activities for penalties tied.
Richard I. Eisenstadt: And $1 million in direct costs related to wind down and closing up a hefty Sal as announced on March 27, 2020 for R&D expenses in the first quarter of 2023 included $8 $9 million in direct expenses associated with the development of Panthers tide and $2 $1 million of direct expenses.
Richard I. Eisenstadt: <unk> South development activities.
Richard I. Eisenstadt: General and administrative expenses were $5 $3 million in the first quarter of 2024 versus $4 $5 million in the first quarter of 2023 to $800000 increase is due primarily primarily too.
Richard I. Eisenstadt: Increase in stock compensation and other labor related expenses, our quarterly noncash operating expenses for the first quarter 2024 was three $8 million all of which are recurring expenses.
Richard I. Eisenstadt: Our quarterly non-cash operating expenses for the first quarter of 2024 were $3.8 million, all of which are recurring expenses. Net loss for the three months ended March 31st, 2024, was $24.4 million, or $0.34 net loss per share, compared to a net loss of $20.1 million, or $0.40 net loss per share, for the first quarter of 2023. The increase in net loss in the quarter is primarily attributable to $4.2 million in higher research and development expenses as we ramp up the IMPACT Phase 2b trial and match.
Richard I. Eisenstadt: Net loss for the three months ended March 31, 2024 was $24 4 million or 34 net loss per share compared to net loss of $20 1 million or 40 net loss per share for the first quarter of 2023, the increase in net loss in the quarter is primarily attributable.
Richard I. Eisenstadt: The $4 $2 million.
Richard I. Eisenstadt: Research and development expenses as we ramp up the impact phase two b trial in Nash.
Vipin Garg: I will now turn it back over to Vipin for his closing remarks. Okay, Vipin? Thank you, Rich. We remain excited for what the future holds. With several important milestones in the coming months, we believe that Altimmune is well-positioned for long-term value creation as we continue advancing the development of the family do-type vaccine. Operator, that concludes our formal remarks, and we would like to open the line to take questions. Thank you. As a reminder, to ask a question, please press star 1-1.
Richard I. Eisenstadt: I will now turn it back over to <unk> for his closing remarks, Kevin. Thank you rich.
Richard I. Eisenstadt: We remain excited for what the future holds at several important milestones in the coming months, we believe that ultimately and is well positioned for long term value creation as we continue advancing the development of <unk>.
Richard I. Eisenstadt: Operator.
Speaker Change: That concludes our formal remarks.
Speaker Change: And we would like to open the line to take questions.
Operator: Thank you. As a reminder to ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-again. As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. Please stand by while we compile the Q&A roster. Our first question comes in the line for Roger's song from Jeffries.
Speaker Change: Thank you.
Speaker Change: Minder to ask a question. Please press star one one on your telephone and wait for your name to be announced.
Speaker Change: To withdraw your question. Please press star one one again.
Speaker Change: As a reminder to ask a question. Please press star one one on.
Speaker Change: Your telephone and wait for your name to be announced please.
Speaker Change: Please standby, while we compile the Q&A roster.
Speaker Change: Okay.
Speaker Change: Our first question comes from the line of Roger song from Jefferies.
Roger Song: Great. Thanks for the update and taking our questions. A couple from us.
Roger Song: Great. Thanks for the update and thank you have a question.
Roger Song: The first one is related to your upcoming phase two meeting with the FDA for your obesity program. Given penicillin has a playtropic effect in many different ways to differentiate, I'm just curious what kind of endpoints you will plan to incorporate into your program to really capitalize on those differentiations in the potential label. And then I have a follow-up question related to your new development. Thank you.
Roger Song: A couple from us.
Roger Song: The first one is related to your upcoming phase <unk> immediate with the FDA for Ya obesity program.
Roger Song: Given <unk> Thai hot topic.
Roger Song: Topic.
Speaker Change: Fact is many gift.
Roger Song: Ways to differentiate.
Speaker Change: Just curious.
Speaker Change: Paul.
Roger Song:
Paul: What kind of endpoints you will plan to incorporate into your pro glad she really capitalized.
Speaker Change: Sure in the <unk>.
Roger Song: Potential label.
Roger Song: And then the hub.
Roger Song: Follow up question really developing.
Speaker Change: Thank you.
Scott Harris: Thanks, Roger. Scott, do you want to take that? Yeah, Roger. Well, thank you for the question.
Scott: Thanks, Roger Scott do you want to take that.
Scott Harris: Yeah, Roger. Well, thank you for the question. We're greatly looking forward to the end of phase two meeting. We think it's going to be a great value-enhancing event to really set forward our program and to really maximize the value proposition. And I think you've hit the nail on the head with what the objective of the meeting will be.
Scott Harris: Yeah. Roger Thanks for the question we are greatly looking forward to the end of phase II meeting, we think it's going to be greatly value enhancing.
Scott Harris: Really set forward our program and to really maximize the value proposition I think you've hit the nail on the head with what the objective of the meeting will be I mean, just as an oversight. We expect the program to have about 5000 patients we're making.
Scott Harris: I mean, just as an oversight, we expect the program to have about 5,000 patients. We're taking a good look as to whether we want to conduct, say, three or four pivotal trials across those 5,000 patients. But I think the key thing will be to choose the best population that will most meaningfully bring out the effects of penvidutide, the effects on lipids, the effects on body composition, and the effects on liver fat.
Scott Harris: And a good look as to whether we want to conduct say three or four pivotal trials across those 5000 patients.
Scott Harris: But I think the key thing will be to choose the best population that will most meaningfully bring out.
Scott Harris: The effects of <unk> the effects on the lipids the effects on the body composition.
Scott Harris: So a lot of the discussion will center around choosing the population for the study. I think some other important points here will be selecting the optimal treatment duration. We got great results at 48 weeks, but is there the potential for getting even better results in weight loss and even better body composition at a longer time point? That's the decision we're really looking forward to making with the FDA. As you know, we had a 25% loss of lean mass and 75% loss of fat mass at 48 weeks.
Scott Harris: The effects on the liver fat so that a lot of the discussion will center around choosing the population for.
Scott Harris: For the studies.
Scott Harris: Some other important points here will be selecting the optimal treatment duration.
Scott Harris: Got great results at 48 weeks, but is there a potential.
Scott Harris: We're getting even better results in weight loss and even better body composition at a longer time point that decision, we're really looking forward to making with the FDA. As you know we had 25% loss of <unk>, 75% loss of fat mass.
Scott Harris: But that ratio of lean to fat goes down over time. So if followed out over a longer period of time, that ratio should drop even further and put PEMDAT2 tied at the top of its class in terms of its preservation of lean mass. So you know, the number of trials, the selection of the population to maximize the value proposition, particularly lipids, liver fat, body composition, and the duration of treatment are all things that we aim to get agreement on with the agency when we meet with them.
Scott Harris: At 48 weeks, but that ratio of lean to fat goes down over time. So are followed out over a longer period of time that ratio should drop even further and.
Scott Harris: And put pen to two tied at the top of its class in terms of its preservation of lean mass so.
Scott Harris: The number of trials.
Scott Harris: The selection of the population to maximize.
Scott Harris: The value proposition pitch early the lipids liver fat the body composition and the duration of treatment are all things that we aim to get agreement with the agency when we meet with them.
Scott Harris: Okay.
Scott Harris: Got it. Thank you. Thank you, Scott.
Speaker Change: Got it. Thank you. Thank you Scott.
Speaker Change: Maybe quickly on your potential new develop.
Roger Song: Maybe quickly on your potential new development on two ends. One is the new indication for pendicitis. Just curious, I understand you're not disclosed yet, but just curious about that kind of a co-morbidity with obesity, MASH, or something pretty orthogonal to the current obesity and MASH population. And in terms of your oral peptide development, just curious about the formulation and how you think about the scalability of your oral peptide. Thank you.
Speaker Change: Two and one is that the new indication for <unk>, just curious I understand youre not disclosed yet, but just curious in that.
Roger Song: Caliber comorbidity with that.
Roger Song: Obesity mash all sort of seeing.
Roger Song: Pretty orthogonal to the current obesity and Nash population and in terms of your oral tablet the tide.
Roger Song: Development, just curious what will be the formulation and how do you think about the.
Roger Song: The scalability for your <unk>. Thank you.
Vipin Garg: Well, thanks for the question, Roger. I'll answer the question about the emerging development program, and I'll then turn over to Scott Roberts to specifically answer the question about the oral formulation. So, as you know, companies are pursuing new indications surrounding obesity in order to maximize their value proposition. With regard to Altimmune, we are specifically, as you pointed out, looking for indications that reflect the value proposition of glucagon, which is very differentiating.
Speaker Change: Well thanks for the question Roger I'll answer the question about the.
Vipin Garg: The emerging development program on all then turn it over to Scott Roberts to specifically answer the question about the oral formulation. So as you know companies are pursuing new indications.
Scott Roberts: Surrounding obesity in order to maximize their value proposition with regards to ultra immune where specifically as you pointed out looking for indications.
Vipin Garg: That reflect the value proposition of glucagon, which is very differentiating so the effects of glucagon on serum lipids for example, the.
Vipin Garg: So the effects of glucagon on serum lipids, for example, the effects on body composition, and also diseases of the liver that are associated with fatty liver or even obesity. So we believe that the indications will reflect specifically what glucagon brings to the table. And we're very hopeful to make a decision about new programs in the near future. But now I'm gonna turn it over to Scott Roberts to answer the question about the oral formulation. Scott. Hey, good morning, Roger.
Scott Roberts: The effects on body composition and also diseases of the liver that are associated with fatty liver or even obesity. So we believe that the indications will reflect specifically what glucagon brings to the table and we're very hopeful to make a decision about new programs in the near.
Vipin Garg: Future, but now I'm going to turn it over to Scott Roberts to answer the question about the oral formulation Scott good morning Roger.
Scott Roberts: Hey, good morning, Roger. As we've indicated in the past, you know, we're pursuing a number of different approaches, different types of formulations, different matrices to obtain an oral formulation for PEMBEDUTI. Those studies are ongoing. You know, the work is slow. You find a formulation that has some merit and is looking good, and it's optimized and then retested. So, it's a reiterative process, and we're in the middle of that with a number of different approaches.
Scott Roberts: As we've indicated in the past we're pursuing a number of different approaches different types of formulations different.
Scott Roberts: Matrices too.
Scott Roberts: Obtaining an oral formulation of <unk>. Those studies are ongoing work is incremental you find a formulation that has some merit and is looking good and it's optimized and then re tested so it's a rebid process and we're in the middle of that with a number of different different approaches.
Scott Roberts: We are expecting and hoping to still nominate a candidate for development by the end of the year. As far as the scalability question is concerned, one of the criteria that we set for a successful oral formulation is a specific level of bioavailability to ensure that the amount of drug substance required for that would be appropriate, attainable, and useful. So scalability, if we have a successful formulation, will not be an issue, and we continue to make progress on all fronts.
Scott Roberts: We are expecting and hoping to still nominate a candidate for development by the end of the year as far as that scalability question one of the criteria.
Scott Roberts: That we.
Scott Roberts: Set for successful oral formulation as a as a specific level of bioavailability to ensure that the amount of drug substance required for that would be appropriate and attainable and useful. So so the scalability. If we have a successful formulation will not be an issue.
Scott Roberts: And we're continuing to make progress on all fronts.
Roger Song: Great, thank you. That's all from us.
Scott Roberts: Okay.
Speaker Change: Great. Thank you that's all from us.
Operator: Thank you. One moment for our next question. Our next question comes from the line of Yasmeen Rahimi from Piper Sandler.
Speaker Change: Thank you.
Yasmeen Rahimi: One moment for our next question.
Yasmeen Rahimi: Our next question comes from the line of Yasmin Rahimi from Piper Sandler.
Yasmeen Rahimi: Hey, Deane good morning, Tim Gallagher, yes, thanks for taking the questions.
Yasmeen Rahimi: First could you comment in regards to finding the right partner is discontinued.
Yasmeen Rahimi: <unk> impacted results.
Yasmeen Rahimi: And secondly, with upcoming Eagle Conference.
Yasmeen Rahimi: You hope to gain from competitor presentations to satellite and John program and increase the probability of success.
Scott Harris: Scott, do you want to take the second question first? Yeah.
Operator: Yes.
Operator: Scott do you want to take the second question first.
Scott Harris: Yes, so I think if I heard correctly, and I apologize if I did not, you're asking about the upcoming liver meetings in Europe, the easel meetings, is that correct? Yes, that's correct.
Yasmeen Rahimi: Yes, so I think if I heard correctly and I apologize if I did not you are asking about the upcoming liver meetings in Europe, the easel meetings.
Yasmeen Rahimi: Is that correct.
Scott Harris: Well, let me start by saying that we have a variety of presentations that are planned for meetings across the entire year. So we will be represented at EASL. We have three presentations at EASL, and those have been posted on the EASL website.
Scott: Alright, let me start by saying that we have a variety of presentations.
Scott Harris: Those will address specific aspects of the effects of pembidutide in MASH and in its metabolism, its effects on metabolism. And, you know, we think that that will continue to be differentiating, but the... The impact on the science, the impact on the differentiation, the value proposition, the body composition data, and the effects on lipids. The effects and other aspects of lipids that have not really gotten as much attention. These things will all come out at key scientific conferences over the course of the year.
Scott Harris: Do you want to comment on what we expect to learn from other presentations? Well, you know...
Scott Harris: Well, you know, there will be some presentations on other compounds. For example, we anticipate that the Cervidutai data will be presented at ESOL, and there will also be some presentations on tercepetide. As you know, they've had top-line readouts of their results, at least in press releases. We're looking forward to that. As you know, the tercepatide data did not hit the fibrosis endpoint, which is something we would have expected from a mechanism that doesn't have glucagon, and Cervidutai does have glucagon, and they've announced that they achieved a statistical significance in the fibrosis endpoint, and we look forward to hearing that, but we would emphasize that that's due to the presence of In terms of your question about
Scott Harris: For example, we anticipate that the serve <unk> data will be presented at <unk> and will also be some presentations on <unk> appetite as you know they've had topline readouts.
Vipin Garg: In terms of your question about the right kind of partner, we've always maintained that, you know, the compound that we are developing, Pembidutide, has very compelling data both in obesity as well as in MASH. And if you think about it, MASH and obesity really intersect each other. It's going to be hard to differentiate in these patient populations down the line because most people with MASH also need to lose weight.
Vipin Garg: Mash and obesity really intersect each other it's gonna be hard to differentiate and and these based on population is down the line because most people with mash also need to lose weight. So we think we bring a perfect combination of these two things. So I'll focus has been and in terms of the right partner has been on <unk>.
Vipin Garg: So we think we bring a perfect combination of these two things. Our focus has been, in terms of the right partner, on partners that value both of these indications. And our goal is to find a partner that would help us develop both of these indications in parallel.
Vipin Garg: That value both of these indications and and and I'll go to <unk> to find a partner that would help us develop both of these indications in case I don't know.
Speaker Change: Alright, thank you so much.
Vipin Garg: One moment for our next question. Our next question comes from the line of Corinne Johnson from Goldman Sachs. Good morning. This is Omari on behalf of
Speaker Change: Thank you.
Speaker Change: One moment for next question.
Corinne Johnson: Our next question comes from the line of Karen Johnson from Goldman Sachs.
Omari: Good morning. This is amari on for courage. So a couple of questions for us cause we we provide an update on how the partnership discussions are progressing.
Omari: And do you plan to bring in a partner for the new indication you want to pursue what <unk>.
Vipin Garg: Yeah, I mean, in terms of, thanks for the question. In terms of the partnership discussion, that continues to be a topic of interest. What I can say is that our partnering efforts are ongoing. We have, you know, the numerous factors that come into play in sort of finalizing a partnership discussion. So stay tuned.
Omari: Yeah, I mean in terms of thanks for the question.
Vipin Garg: In terms of the partnership discussions that continues to be a topic of interest what I can say that our partners partnering efforts are ongoing.
Vipin Garg: We have numerous factors that come into play and sort of finalizing a partnership discussion. So stay tuned those efforts are ongoing and and we expect to have a partner before we go into into phase III development for obesity.
Vipin Garg: Those efforts are ongoing, and we expect to have a partner before we go into phase three development for obesity. As we mentioned earlier in the call, we are getting ready for the end of phase two meeting. We think that's going to be very valuable, having that information as well as additional data. In terms of the additional indications, yeah, I mean, these indications really are an extension of obesity and MASH, sort of the broader indication in obesity and MASH. And we're trying to figure out where our compound has the maximum value creation opportunity and differentiation opportunity relative to other compounds that are mainly GLP-1 focused.
Vipin Garg: We as we mentioned earlier in on the call. We are getting ready for the end of phase two meeting, we think that's going to be very value driving having that information as well as additional data in terms of the additional indications.
Vipin Garg: Yeah, I mean, this indications really are an extension of obesity and mash the sort of the broader indication and obesity in mass and we're trying to figure out where does our compound has the maximum value creation opportunity defense UCH, an opportunity relative to other compounds that are mainly GOP one focused.
Operator: Thank you. One moment for our next question. Our next question comes from the line of Alana Lalo from Guggenheim.
Vipin Garg: Thank you one moment for next question again.
Operator: Oh.
Alana Lalo: Our next question comes from the line of of Lana Layla from Guggenheim.
Alana Lalo: Hi there, thanks for the question. I just wanted to circle back a little bit on the potential outcome of the Synergy Nash study and go back to the partnerships again. So with Synergy Nash, from my understanding, it was said that they had hit a clinically meaningful benefit on cyborosis, but there was no direct commentary on whether that was statistically significant or not. If it turns out that terseptide does lead to statistically significant fibrosis benefits, But how do you see that impacting the prospects of Penn in Ash?
Alana Lalo: Hi, there. Thanks for the question I, just wanted a circle back a little bit on the potential outcome of the synergy Nash studying and accurate partnerships again, so <unk>.
Alana Lalo: Nash Uhm from my understanding they it was said that they had hit a clinically meaningful benefit onsite process, but there is no direct commentary on whether that was statistically significant or not.
Alana Lalo: If it turns out that test appetite does lead to <unk> statistically significant fibrosis benefit how do you see that impacting the prospects of pattern and ash.
Scott Harris: Well, thanks for the question, Lana. So, as we've continued to state, these drugs do not have the same liver defiling effect or effect on fibrosis improvement that a compound rich in glucagon has. So it is possible that they could have meaningful results, potentially statistically significant. These drugs will eventually have effects on fibrosis if you have enough patience. And you follow them out long enough. And we know that from bariatric surgery, where it's simply a reduction of caloric intake.
Speaker Change: Well thanks for the question Lana So as we've continued to state.
Scott Harris:
Scott Harris: These drugs do not have the same liver defiling effect or effects.
Scott Harris: On fibrosis improvement that a compound Richard Goofy doghouse.
Scott Harris: So it is possible.
Scott Harris: They could have meaningful results potentially statistically significant.
Scott Harris: These drugs will eventually have a drugs effects on fibrosis. If you have enough patience and you follow them out long enough and we know that from Beria trick surgery with that simply a reduction of Clark intake.
Scott Harris: So eventually, they would hit an endpoint, given enough patience and enough time. But I think you've seen from our original data that the speed and the robustness of the effects are tremendously enhanced in the presence of glucagon, such that we can get a better treatment effect and actually read it out at an earlier time point. So, we would congratulate them if they achieved statistical significance, but we would also highlight the fact that we believe that we will do better.
Scott Harris: So eventually they would hit an unemployed given enough patients in enough time.
Scott Harris: But I think you've seen from our original data that the speed and the robustness of the effects are tremendously enhanced in the presence of looking on.
Scott Harris: Such that we can get a better treatment effect.
Scott Harris: And actually read it at an earlier time point so we.
Scott Harris: We would congratulate them if they achieve statistical significance.
Scott Harris: Would also highlights the fact that we believe that we will do better.
Vipin Garg: Great, thank you for that clarification. And then, just very quickly, on the partnerships, with respect to timing, are you still confident that a partner can be secured this year, or are you thinking that it might be more likely after the NASH data hits 1Q25?
Speaker Change: Great. Thank you for that clarification, and then just very quickly on the partnerships with respect to timing is it are you still confident that a partner can be secured this year or are you thinking that it might be more likely.
Vipin Garg: After the nasty in the head.
Vipin Garg: <unk> 25.
Vipin Garg: Yeah, thanks for the question, Alana. Look, it is difficult to pinpoint the timeline for partnering. As I've said, our efforts are ongoing. We would love to have a partner before the end of the year, before we start the obesity phase three program. But let's see how things develop on that front. As our discussions progress, we'll know better. But at this point, we are committed to having a partner on board before the start of phase three in obesity. Great, thanks so much.
Speaker Change: Yeah. Thanks for the question and then I look at it is difficult to pinpoint the timeline for partnering.
Vipin Garg: As I've said our efforts are ongoing we would.
Vipin Garg: Love to have our goal remains to have a partner before the end of the year before we start the the.
Vipin Garg: Obesity phase III program.
Vipin Garg: But let's see how things develop.
Vipin Garg: On that front.
Vipin Garg: As our discussions progress we'll know better.
Vipin Garg: But at this point we.
Vipin Garg: We are committed to having a partner on board before the start of phase III and obesity.
Vipin Garg: Great, thanks so much for taking my question.
Speaker Change: Alright, thanks, so much for taking my question.
Speaker Change: You're welcome.
Operator: One moment for our next question. Our next question comes from the line of Mayank Mamtani from B. Riley Securities.
Speaker Change: Thank you.
Vipin Garg: One moment for next question.
Mayank Mamtani: Our next question comes from the line of my Yang Montana from be Riley Securities.
Mayank Mamtani: Good morning team. Thanks for taking our questions and good to see the phase two, in a phase two meeting being calendared. So maybe just on that quickly, are you able to share how your specific plans could vary relative to, say, the step-in for amount program? I believe Amgen may also be having similar FDA correspondence around the same time. So I wonder if, you know, any guidance from an FDA standpoint on this next wave of weight loss drugs could be relevant here. And also, if you are able to comment on the outcome trial commitment, how big that could be given, obviously, you have a big lipid benefit. And then I have a couple of follow-up questions.
Mayank Mamtani: Good morning team, thanks for taking our questions and we get to see the face to face meeting being calendar. So maybe just done that quickly.
Mayank Mamtani: Sure how your specific plans could very relative to say step in Vermont program.
Mayank Mamtani: Leave the Amgen may also be having similar MDA Gladys fall into that same time to wonder if you know.
Mayank Mamtani: Any guidance from an F D. As standpoint on this next <unk> could be relevant here and also if you are able to comment on the outcome trial commitment how big that could be given obviously you have a big lipid benefit and then I have a couple of follow ups.
Scott Harris: Well, thanks for the question, Mayank. I'm not sure I heard the entirety of the first question, so please continue if I don't answer it completely.
Speaker Change: Well thanks for the question my I'm not sure I heard the entirety of the first question. So please persists of I don't answer it completely.
Scott Harris: So look, this meeting that we're going to have later this year is going to be extremely value-enhancing for the company. And there are a lot of great things that we can get done at this meeting that really enhance our goals and objectives, specifically around glucagon and what glucagon brings to the table in the treatment of obesity. So we're expecting that there will be certain things in place. Um, that are expected, a safety database of 5,000 subjects and probably distributing those subjects across three to four trials. We're going into the meeting with that expectation.
Speaker Change: Look this meeting that we're gonna have later this year.
Scott Harris: Going to be extremely value enhancing for the company.
Scott Harris: And there are a lot of great things that we can get done with this meetings that really enhance.
Scott Harris: Our goals and objectives, specifically around glucagon and work with you on brings to the table and the treatment of obesity.
Scott Harris: So we're expecting that there will be certain things in place.
Scott Harris:
Scott Harris: That are expected safety database of 5000 subjects and.
Scott Harris: Probably distributing those subjects across three to four Charles we're going into the meeting without expectation.
Scott Harris: And more than likely, there'll be a trial without diabetics and with diabetics, but there's still room for..., Creating Trials with Endpoints in Populations that enhance the value proposition of pembedutide and the role of glucagon in the treatment of obesity and provide differentiation as the obesity market becomes more substantial and becomes more segmented. So, as we know, the obesity population right now is not well differentiated Right now, there's not a great certainty about what those segments will look like.
Scott Harris: And more than likely there'll be a trial without diabetics and with diabetics, but there's still room for.
Scott Harris: Creating trials with endpoints in populations.
Scott Harris: That enhance the value proposition of temperature tied in the role of <unk> in the treatment of obesity and.
Scott Harris: And provide differentiation.
Scott Harris: <unk> market becomes more subs becomes more segmented.
Scott Harris: So as we know the obesity population right now is not well differentiated.
Scott Harris: Right now there's not great certainty about what those segments will look like we know that it will become more segment of the same way hypertension became differentiated over time.
Scott Harris: We know that it will become more segmented, the same way hypertension has become differentiated over time. So our goal is to ride that wave and to find ways that we can really stress differentiation based on the glucose mechanism, and as I pointed out before, that could include choosing the best population, for example, to enrich for the lipid effects, looking at body composition changes over time, looking at different durations of treatment in order to maximize the amount of weight loss, since, as you know, the weight loss was steeply continuing at 48 weeks in the trial, and the improvement in
Scott Harris: Goal is to ride that wave and defined ways that we can really stress differentiation based on the <unk> mechanism and as I pointed out before that could include choosing the best population for example to enrich on the liver lippitt effects looking at body composition changes over time <unk>.
Scott Harris: Looking at different duration, so treatment in order to maximize the amount of weight loss and says you know the weight loss was steeply continuing at 48 weeks in trial and the improvement of our body composition now with respects the body composition, we know.
Scott Harris: Now, with respect to body composition, we know that loss of lean mass is associated with loss of function and also a higher rate of bone fracture, particularly in the elderly and also in women. So we saw in the semi-glutide trial, they had a 40% loss of lean mass, which exceeds the natural weight loss, the natural loss of lean mass from diet and exercise, which is about 25%, which is what we achieved. But with that 40% lean loss.
Scott Harris: Loss of lean mass.
Scott Harris: Associated with loss of function.
Scott Harris: And also a higher rate of bone fractures.
Scott Harris: Eric early in the elderly and also in women.
Scott Harris: So we saw on the <unk> trial, they had a 40% loss of lean mass, which exceeds the natural weight loss the natural loss of lean mass from diet and exercise, which was about 25% which is what we achieved.
Scott Harris: But with that 40% lean loss.
Scott Harris: In their label, they report a higher rate of fractures in women and the elderly. So now you can see the immediate implications on the market and the differentiation between the segments. For example, because of its preservation of lean mass, Pembedutai could be ideally suited for treating the elderly, especially frailer individuals, or women with osteoporosis risk, which is a huge segment of the population, recognizing that women with lean bone mass are carrying around extra weight, which increases the risk of fractures. So, all in all, these are discussions that we'll have with the FDA as we choose our target population and our endpoints.
Scott Harris: In their label their report a higher rate of fractures and women and the elderly.
Scott Harris: So now you can see the immediate implications on the market and the differentiation on the segments. For example, because of its preservation of lean mass could <unk> be ideally suited for treating the elderly, especially for older individuals where women with osteoporosis risk, which is a huge segment of the <unk>.
Scott Harris: Population, recognizing that women with lean bone mass are carrying around extra weight, which increases the risk of fractures. So all in all these sort of discussions that will have the fda's, we choose our target population and our endpoints.
Scott Harris: Super helpful. I think you covered a lot. If you could comment on the outcome trial, scale, and scope, given you have a big lipid benefit.
Speaker Change: Super helpful. I think you've covered a lot if you could comment on the outcome trial.
Scott Harris: Score scale and scope, giving you have a big lipid benefit.
Scott Harris: Right. Obviously, that's going to be of great benefit to us. I think that's where we can really differentiate, because as you're aware, in the select trial, there was a 20% reduction in MACE, major adverse cardiac events, just on the basis of weight loss alone. And their effects on serum lipids are minimal at best. I believe they're, if I'm quoting the data correctly, a reduction of LDL cholesterol and total cholesterol only in the range of about three to 5%.
Scott Harris: Obviously, that's going to be of great benefit to us I think that's where we can really differentiate because as you are aware in the select trial. There was a 20% reduction of mace major adverse cardiac events just on the basis of weight loss alone and their effects on certain lipids are minimal at best I believe they're <unk>.
Scott Harris: Putting the data correctly, the reduction of LDL cholesterol and total cholesterol only in the range of about 3% to 5%.
Scott Harris: Recognize that in our population of subjects with elevated serum lipids at baseline, we saw a 21% reduction in LDL, which is comparable to the effects of statins. So going into that trial, we could have really very excellent effects that exceed those seen with semaglutide. We also have reported data on lipidomics in the past, showing that not only does penvadutide reduce the amount of LDL and total cholesterol, but it also changes the very nature of the lipids that are circulating, inflammatory lipids that are known to damage the cardiovascular system and liver, like ceramides and diacylglycerols.
Scott Harris: Recognize that in our population of subjects with elevated serum lipids to baseline we saw a 21% reduction of LDL, which is comparable to the effects of status. So we are going into that trial, we could have really very excellent.
Scott Harris: Excellent effects that exceed that scene with with some <unk>. We also have reported outdated on lipitor mix in the past showing that not only this pen voodoo Todd reduce the amount of LDL and total cholesterol. It also changes the very nature of the lipids that are circulating inflammatory listen lipids.
Scott Harris: Known to damage the cardiovascular system and liver <unk> glycerol. So we're very optimistic about conducting the trial optimistically that as a trial that we'd like to.
Scott Harris: So we're very optimistic about conducting that trial. Optimistically, that is a trial that we'd like to start with in Phase 3 and get results as soon as possible so that we have it around the time of market authorization. And that would be something that we hope to achieve in the discussions with the FDA.
Scott Harris: To start with and phase III and get through so assaults as soon as possible. So that we have it around the time of.
Scott Harris: Market authorization.
Scott Harris: And that would be something that we would hope to achieve in a discussion with the FDA.
Scott Harris: Got it. And then just on the MASH development, and you know, you have FastTrack there. There's another glucagon-directed program, which is now in phase three, based on NIT endpoints, weight loss, and MNIPDFF, no biopsy. I was just curious if you could also get some preliminary guidance on what your late-stage MASH development could look like, and maybe just remind us about enrollment for impact, you know, if you're on track to complete enrollment in 3Q. Thanks again for taking the time.
Speaker Change: Got it and then just one b dash.
Scott Harris: Development and you have <unk>, there's another glucagon directed program the child now faithfully.
Scott Harris: Based on <unk>.
Scott Harris: Coin cloud and I.
Scott Harris: <unk> <unk> <unk>.
Scott Harris: Curious if you could also get.
Scott Harris: Some preliminary guidance unlucky late stage mash development could look like and and maybe just remind us on the Android mentally and that.
Scott Harris: Are you on track will complete enrollment in three Q, thanks, again for being a musician.
Scott Harris: Yeah, thanks for the question, Mayank. The obesity meeting is going to be with the endocrine division. Our NASH program is going to be with the liver division, so I don't really think there's going to be an immediate opportunity to get information about the NASH development. Of course, there is overlap and interchange of ideas, and clearly, any information we get from obesity, we can take forward to enhance NASH development. Regarding enrollment, it's going extremely well. We think this reflects the fact that patients with NASH are seeking treatments that have visible, clear effects on them that they can see, because mash is a silent disease.
Speaker Change: Yeah. Thanks for the question.
Scott Harris: The obese.
Scott Harris: Obesity meeting is going to be with the endocrine division. The Nash program is going to be with the.
Scott Harris: <unk> Division, so I don't really think there's going to be an immediate opportunity to.
Scott Harris: Get information about the Nash development of course, there are there are there are there is overlap and interchange of ideas and clearly any information we get from obesity, we can take forward to enhance Nash development.
Scott Harris: Regarding enrollment is going extremely well.
Scott Harris: We think this reflects the fact that patients with Nash are seeking treatments that have visible clear effects on them that they can see.
Scott Harris: Mashes a silent disease.
Scott Harris: And what they see on a day-to-day basis is their body weight. So given the opportunity to lose weight in the trial, they're coming into the trial at very high rates, and this robust rate of enrollment is going to support, as we've said, the readout in the first quarter of next year.
Scott Harris: And what they see on a day to day basis as their body weight.
Scott Harris: So given the opportunity to lose weight and the trial.
Scott Harris: They're coming into the trial at very handsome rates and robust rate of enrollment is going to support us. We've said the read out in the first quarter of next year.
Scott Harris: Got it. Thank you.
Speaker Change: Got it thank you.
Operator: Thank you. One moment for our next question. Our next question comes from the line of John Wolleben from Citizens JMP.
Speaker Change: Thank you one.
Jonathan Patrick Wolleben: One moment for next question.
Jonathan Patrick Wolleben: Our next question comes from the line of John Wallet banned from citizens J M P.
Jonathan Patrick Wolleben: Hey, thanks for taking the question. We had some data last night from another GLP, glucagon agonist, I was wondering if you guys saw, because we've heard some critiques that glucagon agonist may not be effective and even detrimental for diabetics, but this data said that Chinese patients showed superiority to dulaglutide, and I was wondering your thoughts on that data set, and do you see any read-through of pembidutide and others in the class, and how are you thinking about the diabetic population as an opportunity for pembidutide?
Jonathan Patrick Wolleben: Hey, Thanks for taking the question.
Jonathan Patrick Wolleben: We had some data last night from another GOP glucagon agonist I was wondering if you guys saw.
Jonathan Patrick Wolleben: Because we've heard some critiques that quicker than agonist may not be effective and even.
Jonathan Patrick Wolleben: Detrimental for diabetics, but.
Jonathan Patrick Wolleben: Data set in Chinese patients showed superiority to do look we retired and I was wondering.
Jonathan Patrick Wolleben: Your thoughts on our data centers, you see any read-through depended too tired and others in the class and how you're thinking about.
Jonathan Patrick Wolleben: Diabetic population is an opportunity for temperatures type.
Scott Harris: Well, thanks, Jonathan. So, you know, just to emphasize that we've seen excellent control of blood glucose in our program. And this drug is not designed specifically based on its ratio of GLP-1 and glucagon to drive down blood sugar or hemoglobin A1C, but it clearly maintains it safely while patients derive a whole variety of other benefits. So, you know, we continue to believe that the data that you've talked about, as well as our own data, supports the safety and effectiveness of the drug in all populations, including diabetics.
Speaker Change: Well thanks, Jonathan.
Scott Harris: So you know.
Scott Harris: Just to emphasize we've seen excellent control of blood glucose Center program.
Scott Harris: And this drug is not designed specifically based on his ratio jail. If you want a glucagon to drive down blood sugar or hemoglobin, a one C. But it clearly maintains it safely while patients drive a whole variety of other benefits.
Scott Harris: So we continue to believe that the data that you've talked about as well as our own data supports the.
Scott Harris: The safety and effectiveness of the drug and all populations, including diabetics.
Scott Harris: I would emphasize that in our studies weight loss and diabetic, Equivalent to Weight Loss in Non-Diabetics. This is something that's of great interest to us as we go forward into Phase 3, because it is possible that there is something unique about a glucagon mechanism where weight loss is preserved in diabetics, which would be extremely attractive because, as you know, diabetics with GLP-1-based compounds like semaglutide and terzapatide seem to take a haircut in the diabetic population. So we are, you know, extremely interested in pursuing that and believe that we could operate very nicely in the diabetes space.
Scott Harris: Would emphasize that we're seeing in our studies weight loss in diabetics equivalent to the weight loss and non diabetics. This is something that is of great interest to us as we go forward into phase three because it is possible that there is something unique about glucagon mechanism, where the weight loss is preserved and diabetics, which.
Jonathan Patrick Wolleben: And then one more question, if I may, as you guys are playing for your Phase 3 program, can you talk about the tradeoff between the shorter titration, which you guys have talked a lot about in the past, versus improving the tolerability profile with the slower titration like we've seen from other programs, and how you think about the importance of both, and your thoughts going into phase 3?
Jonathan Patrick Wolleben: Would be extremely attractive because as you know diabetics with the G. L. P. One based compounds like <unk> seem to take a haircut and the diabetic population.
Jonathan Patrick Wolleben: So we are extremely interested in pursuing that and believe that we could operate very nicely in the diabetes space.
Speaker Change: Okay, and then one more if I may just how it is.
Jonathan Patrick Wolleben: You guys are playing for your Phase III program can you talk about the trade off between the shorter titration, which you guys have talked a lot about in the past versus.
Jonathan Patrick Wolleben: Improving tolerability profile with a slower titration like we've seen from other programs and how do you think about the importance of both.
Jonathan Patrick Wolleben: And your thoughts going into the phase III.
Scott Harris: Well, thanks. A great question, Jonathan.
Speaker Change: Well. Thanks, Great question, Jonathan is something that we're giving a lot of <unk>. The first thing I would say.
Scott Harris: It's something that we're giving a lot of thought to. The first thing I would say is that the 1.2 dose of penvedutitis is extremely attractive. It has an adverse event profile, an adverse event discontinuation rate similar to placebo, and I want to remind everybody that it's given without dose titration. So we're going to pursue that dose as well as the 1.8 and 2.4 milligram doses going into phase three. But literally, a physician could prescribe, [inaudible] The doctors wait, see how the patients do, and then increase to other doses like 1.8 and 2.4 milligrams as they go forward.
Speaker Change: Is that one.
Scott Harris: Two dose of <unk> Titus extremely attractive.
Scott Harris: It has an adverse event profile, an adverse event discontinuation rate similar to placebo and one remind everybody it's given without dose titration.
Scott Harris: So we're going to pursue that dose as well as the 1824 milligram doses going into phase III, but literally a physician could prescribe.
Scott Harris: A dose of <unk>, that's approved not have to titrate up to it and some patients who are achieving 20% weight loss on that and.
Scott Harris: And the natural use of the drugs in clinical practice is that these drugs are started on the lowest dose.
Scott Harris: The doctors wait and see how the patients due and then increase to other doses like 1.8 to four milligrams as they go forward. So in practice the scheme that you're talking about a titration is really only a construct of clinical trials and practice tact doctors naturally titrate by starting on a low dose waiting observe.
Scott Harris: So in practice, the scheme that you're talking about of titration is really only a construct of clinical trials. In practice, doctors naturally titrate by starting on a low dose, waiting, observing, and then going to the next dose and the next dose.
Scott Harris: Serving and then going through the next dose in the next dose.
Scott Harris: Now, with regard to the construct in clinical trials, we're very happy with the tolerability profile of Pempadutide as we've currently developed it. We know that the allowance of dose reduction, which happens all the time in clinical practice but is specifically allowed in all of the other obesity trials, will greatly enhance the tolerability profile of the compound. We're seeing single-digit adverse event discontinuation rates in our NAFLD trials, and in our diabetes trials, we saw no adverse event discontinuations at all.
Scott Harris: Now with regards to the construct in clinical trials, we're very happy with the Tolerability profile of temperature tied as we've currently developed.
Scott Harris: We know that the allowance of dose reduction, which happens all the time in clinical practice, but specifically allowed in all of the other obesity trials will greatly enhance the tolerability profile of the compound we're seeing single digit adverse event discontinuation rates and our mash.
Scott Harris: Natural D trials in our diabetes trials, we saw no adverse event discontinuations at all.
Scott Harris: And at the 1.8 milligram dose, there was no nausea reported. So, aside from the obese population, this drug is very well tolerated in a phase three program. It's something that we've considered. It's something on the table as we go forward into discussions with the FDA.
Scott Harris: And at 1.8 milligram dose there was no nauseated reported so that aside from the obesity population. This drug is very well tolerated that being the case there is the optionality to pursue longer dose titration.
Scott Harris: Phase III program is something that we've considered it something on the table as we go forward into discussions with the FDA.
Jonathan Patrick Wolleben: A very helpful caller, Scott. Looking forward to seeing those details when you announce them.
Jonathan Patrick Wolleben: Very helpful Colored Sky look at for the fee in those details on your announcement.
Jonathan Patrick Wolleben: Jonathan.
Vipin Garg: Thank you. At this time, I am not showing any further questions. I would now like to turn the conference back over to Vipin Garg for closing remarks.
Speaker Change: Thank you.
Vipin Garg: This time I am showing no further questions I would now like to turn the conference back over to Vipin Guard for closing remarks.
Vipin Garg: Thank you. Thank you, everyone, for participating today. We appreciate this opportunity to share our results and outlook with you, and thank you for your continued support. Have a wonderful day.
Vipin Garg: Thank you. Thank you everyone for participating today, we appreciate this opportunity to share our results and outlook with you and thank you for your continued support have a wonderful day.
Operator: This concludes today's conference call. Thank you for participating. You may now disconnect.
Speaker Change: This concludes today's conference call. Thank you for participating you may now disconnect.
Operator: Mmm.
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Operator: [music].
Operator: Mmm.
Operator: [music].
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