Q2 2024 Altimmune Inc Earnings Call

There are a total of 6 names on this one story, and we know more than 70.

Operator: Good day, ladies and gentlemen, and welcome to Altimmune, Inc.'s second quarter 2024 Financial Results Conference call. 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 call, Leigh Roth of Burns McClellan Investor Relations Advisors to Altimmune. Leigh, you may begin.

Speaker Change: good day ladies and gentlemen and welcome to altooe an second quarter two thousand and twenty-four financial results conference call

Speaker Change: 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.

Operator: To withdraw your question, please press star 11 again.

To withdraw your question, please press star 11 again.

Leigh Roth: As a reminder, this call is being recorded. I would now like to introduce your host for today's conference call, Leigh Roth of Burns McClellan Investor Relations Advisors to Altimmune. Leigh, you may begin.

Leigh Roth: Thanks, Gigi. Good morning, everyone.

Vipin Garg: Thanks, Gigi. Good morning, everyone.

Leigh Roth: Thanks, Gigi. Good morning, everyone. Thank you for participating on the Altimmune second quarter 2024 financial results and business update conference call.

Leigh Roth: Thank you for participating in the Altimmune Second Quarter 2024 Financial Results and Business Update Conference Call. Members of the Altimmune team joining me today are Vipin Garg, our Chief Executive Officer, Scott Harris, our Chief Medical Officer, Ray Jort, our Chief Business Officer, Andrew Shutterly, our Acting Chief Financial Officer, and Scott Roberts, our Chief Scientific Officer. Following prepared remarks from Vipin, Scott Harris, and Andrew, we'll hold a Q&A session. As a reminder, a press release with our Q2 2024 financial results was issued this morning and can be found in the Investor Relations section of the company's website.

Speaker Change: Members of the Altimune team joining me today are Vipin Garg, our Chief Executive Officer, Scott Harris, our Chief Medical Officer, Ray Jort, our Chief Business Officer, Andrew Shutterly, our Acting Chief Financial Officer, and Scott Roberts, our Chief Scientific Officer.

Speaker Change: Following prepared remarks from Vipin, Scott Harris, and Andrew will hold a Q&A session. As a reminder, a press release with our Q2 2024 financial results was issued this morning and can be found on the IR section of the company's website.

Operator: Thank you for participating in the Altimmune second quarter 2024 financial results and business update conference call. 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. For a discussion of some of the risks and the factors that could impact the company's future results and operations, please refer to the risk factors and other cautionary statements contained in our filings with the SEC.

Leigh Roth: 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 our actual results to differ materially from those indicated. For a discussion of some of the risks and the factors that could impact the company's future results and operations, please refer to the risk factors and other cautionary statements contained in our filings with the SEC.

Speaker Change: 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.

Speaker Change: altim cautions that these forward-looking statements are subject to risks and uncertainties that could cause our actual results to differ materially from those indicated

Speaker Change: For discussion of some of the risks and the factors that could impact the company's future results and operations, please refer to the risk factors and other cautionary statements contained in our filings with the SEC.

Leigh Roth: I'll also direct you to read the forward-looking statement disclaimer in our press release issued earlier today and now available on our website. Any statements made during this call speak only as of today's date, Thursday, August 8, 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. As a reminder, this call is being recorded and will be available for audio replay on the Altimmune website. With that, it's now my pleasure to turn the call over to Dr. Vipin Garg, Chief Executive Officer of Altimmune.

Speaker Change: I'll also direct you to read the forward-looking statement disclaimer in our press release issued earlier today and now available on our website.

Speaker Change: Any statements made during this call speak only as of today's date, Thursday, August 8, 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.

Operator: As a reminder, this call is being recorded and will be available for audio replay on the Altimmune website. With that, it's now my pleasure to turn the call over to Dr. Vipin Garg, Chief Executive Officer of Altimmune.

Speaker Change: as a remindder this call is being recorded and will be avilable for audio replay on the ultim website

Speaker Change: with that is now my pleasure to turn the call over to dr ipppand gar chief executive officer of ultime dibin

Vipin Garg: Thanks, Li. Good morning, everyone, and once again, thank you for joining us for our second quarter corporate update. In the second quarter and throughout the first half of the year, we continued to strengthen the rationale for pembidutide as a highly differentiated therapeutic with significant potential in a variety of metabolic diseases. We are continuing to advance our key strategic, clinical, and operational priorities, and we are excited about the milestones that are approaching in both our obesity and MASH programs.

Speaker Change: Thanks Lee. Good morning everyone and once again thank you for joining us for our second quarter corporate update.

Vipin Garg: In the second quarter and throughout the first half of the year, we continued to strengthen the rationale for pembidutide as a highly differentiated therapeutic with significant potential in a variety of metabolic diseases. The American Diabetes Association, or ADA's 84th Scientific Session, at the ADA meeting in June.

Speaker Change: In the second quarter and throughout the first half of the year, we continued to strengthen the rationale for Pembedutide as a highly differentiated therapeutic with significant potential in a variety of metabolic diseases.

Speaker Change: we are continuing to advance our key strategic clinical and operational priorities that excited for the milestones that are approaching in both our obesity and mash programs

Vipin Garg: The quarter was highlighted by important data presentations at two of the most prominent medical meetings in our space, the American Diabetes Association's 84th Scientific Session and the European Association for the Study of the Liver, or ESIL, Congress at the ADA meeting in June. We presented updated data on the effects of PAMD-Dutide on body composition from our Phase II Momentum Obesity trial that demonstrated a class-leading preservation of lean mass among correcting agents.

Speaker Change: The quarter was highlighted by important data presentations at two of the most prominent medical meetings in our space.

Speaker Change: The American Diabetes Association, or ADA's 84th Scientific Sessions, and the European Association for the Study of the Liver, or ESIL Congress.

Speaker Change: oh

Speaker Change: at the ADA meeting in June .

Speaker Change: We presented updated data on the effects of PAMD-Dutide on body composition from our Phase II Momentum Obesity Trial that demonstrated a class-leading preservation of lean mass among incorrecting agents.

Vipin Garg: Preservation of lean mass and the quality of weight loss is becoming increasingly important for the treatment of obesity and for the safety and long-term maintenance of weight loss. In addition, we presented data during the ease of Congress that highlighted the disease-modifying potential of pambiduotide in MASH and reinforces our confidence in achieving both the MASH resolution and fibrosis endpoint in our Phase IIb impact trial. We remain engaged in discussions regarding a global strategic transaction for Pembidu type involving a variety of possible structures.

Speaker Change: Preservation of lean mass and the quality of weight loss is becoming increasingly important for the treatment of obesity and for the safety and long-term maintenance of weight loss.

Speaker Change: In addition, we presented data during the EASL Congress that highlighted the disease-modifying potential of pambiduotide in MASH and reinforces our confidence in achieving both the MASH resolution and fibrosis endpoint in our Phase IIb impact trial.

Vipin Garg: We remain engaged in discussions regarding a global strategic transaction for Pembidu type involving a variety of possible structures. In parallel, we intend to create additional value by completing the impact study and pursuing additional indications. Finally, we continue to prepare for the end of Phase 2 meeting with the FDA to review our registrational program for obesity.

Speaker Change: We remain engaged in discussions regarding a global strategic transaction for PAMBI-DUTAI involving a variety of possible structures.

Vipin Garg: We are intently focused on identifying and securing a partner with the right vision, resources, and commitment to help us realize the full potential of panleidotide in obesity, MASH, and other metabolic conditions. In parallel, we intend to create additional value by completing the impact study and pursuing additional indications, for which Pembry-Dewtide is specially well-suited. Finally, we continue to prepare for the end of Phase 2 meeting with the FDA to review our registrational program for obesity.

Speaker Change: We are intently focused on identifying and securing a partner with the right vision, resources, and commitment to help us realize the full potential of panleidotide in obesity, MASH, and other metabolic conditions.

Speaker Change: in parallel we intend to create additional value by completing the impact study and pursuing additional indications

Speaker Change: for which Pembry-Dewtide is specially well suited.

Speaker Change: finally we continue to prepare for the end of phaseimeeting with the fda to review our registrational program for those obesity

Vipin Garg: The outcome of this meeting will confirm the patient population we believe will benefit most from the Differentiated Profile of PAM-V-DU type. With that, I'll now turn the call over to our Chief Medical Officer, Dr. Scott Harris, to provide additional updates and discuss our plans.

Speaker Change: The outcome of this meeting will confirm the patient population we believe will benefit most from the differentiated profile of PAM-V dutide.

Speaker Change: With that, I'll now turn the call over to our Chief Medical Officer, Dr. Scott Harris, to provide additional updates and discuss our plans. Scott? Thank you, Vipin.

Vipin Garg: To provide a bit more information on some of the points he discussed, Dr. Aroni also presented updated body composition analyses that showed class-leading preservation of lean mass among Inkerton age, with only 21.9% of weight loss attributed to lean mass, while 78.1% of weight loss was associated with fat loss. Pemphigutide treatment led to a 55.8% reduction in triglycerides, a 20% reduction in total cholesterol, and a 17.4% reduction in LDL cholesterol at the 2.4 milligram dose. Since dyslipidemia affects as many as 70% of obesity patients,

Scott Harris: To provide a bit more information on some of the points he discussed, I'd like to turn to the data presented at recent scientific meetings. At the ADA meeting, Dr. Lou Aroni, one of the foremost experts in obesity and metabolic disease and principal investigator in our Momentum Obesity Trial, presented data showing that pemvidutai had led to nearly 16% weight loss in 48 weeks, with a trajectory suggesting additional weight loss with continued treatment

Scott Harris: to provide a bit more information than some of the pointscy discussed

Scott Harris: Dr. Aroni also presented updated body composition analyses that showed class-leading preservation of lean mass among Inkerton age, with only 21.9% of weight loss attributed to lean mass, while 78.1% of weight loss was associated with fat loss. However, available data on other Incretin-based weight loss agents have shown that lean mass loss can account for as much as 40% of the total weight loss. The preservation of lean mass is becoming an increasingly important consideration in the management of obesity as loss of lean mass has been associated with higher rates of bone fractures, reduced physical function, and mortality.

Speaker Change: I'd like to turn to the data presented at recent scientific meetings. At the ADA meeting, Dr. Lou Aroni, one of the foremost experts in obesity and metabolic disease,

Speaker Change: and Principal Investigator in our Momentum Obesity Trial presented data showing that Pembedutide led to nearly 16% weight loss in 48 weeks, with a direct trajectory suggesting additional weight loss with continued treatment.

Speaker Change: Dr. Aroni also presented updated body composition analyses that showed class-leading preservation of lean mass among Inkerton agents, with only 21.9% of weight loss attributed to lean mass

Speaker Change: while 78.1% of weight loss was associated with fat loss.

Speaker Change: Available data on other Inkerton-based weight loss agents have shown that lean mass loss can account for as much as 40% of the total weight loss.

Speaker Change: The preservation of lean mass is becoming an increasingly important consideration in the management of obesity as loss of lean mass has been associated with higher rates of bone fractures.

Scott Harris: The data presented at ADA also demonstrated that pempidutide has pronounced effects on serum lipids associated with cardiovascular risk and a subset of subjects with dyslipidemia. Pemphigutide treatment led to a 55.8% reduction in triglyceride, a 20% reduction in total cholesterol, and a 17.4% reduction in LDL cholesterol at the 2.4 milligram dose. Since dyslipidemia affects as many as 70% of We believe that Pemphidutide could benefit a significant segment of the obesity population. While significant cardiovascular benefits of weight loss were observed with GLP monotherapy in the recent SELECT trial, the effects on lipids were not clinically meaningful.

Speaker Change: Reduce physical function and mortality.

Speaker Change: The data presented at ADA also demonstrated that pempidutide has pronounced effects in serum lipids associated with cardiovascular risk.

Speaker Change: And a subset of subjects with dyslipidemia.

Speaker Change: Pemphigutide treatment led to a 55.8% reduction in triglycerides.

Speaker Change: 20% reduction in total cholesterol, and 17.4% reduction in LDL cholesterol at the 2.4 milligram dose.

Speaker Change: since thislibinemia as effects as many as seventy percent of obesity patients we believe that pentpathe doide could benefit a significant segment of the obesity population

Vipin Garg: While significant cardiovascular benefits of weight loss were observed with GLP monotherapy in the recent SELECT trial, the effects on lipids were not clinically meaningful. The narrative in the obesity space is evolving towards higher quality weight loss. Safe and Effective Maintenance of Weight Loss and the Ability to Directly Address the Comorbidities Associated with Obesity. We believe that Pempidutide, with its excellent preservation of liver mass and its robust reductions in serum lipids and liver fat, is well-positioned compared with other agents.

Speaker Change: while significant cardiovascular benefits of weight loss were observed with glp monotherapy in the recent select trial the effects on lipids were not clinically meaningful

Scott Harris: We believe that with the robust reductions in serum lipids and liver fat observed with panvidutide, we can achieve even greater degrees of cardiovascular benefit in this population. The narrative in the obesity space is evolving towards higher quality weight loss.

Speaker Change: We believe that with the robust reductions of serum lipids and liver fat observed with panbadutide, we can achieve even greater degrees of cardiovascular benefit in this population.

Scott Harris: Safe and Effective Maintenance of Weight Loss and the Ability to Directly Address the Comorbidities Associated with Obesity. We believe that Pempidutide, with its excellent preservation of liver mass and its robust reductions in serum lipids and liver fat, is well-positioned compared with other agents. We will share a comprehensive package of these data with the FDA as part of our upcoming End of Phase II meeting. We look forward to feedback from the FDA on our unique and differentiation-driven approach to a Phase III program designed for obesity.

Speaker Change: the narrative in the obesity space is evolving towards higher quality weight loss safe and effective maintenance of weight loss and the ability to directly address the commoridities associated with obesity

Speaker Change: we believe that penadu tide with its excellent preservation of livermass and this robust reductions and ser lipids and liverfat is well well positioned compared with other agents

Vipin Garg: We will share a comprehensive package of these data with the FDA as part of our upcoming End of Phase II meeting. In addition, an analysis of data from our Phase I trial of metabolic-associated steatotic liver disease, also known as MASL-D, demonstrated that higher proportions of subjects receiving penvadutide achieved improvements in fibroscan aspartate immunotransferase, or FAST, score. Finally, as we have discussed before, we are continuing to evaluate additional indications for Pembedutide that leverage the benefits of glucagon and that, we believe, will create additional value that will be attractive to strategic partners or allow us to develop on our own. We anticipate pursuing up to three additional indications for PEMDU-Tide in areas of greatest unmet medical need, and we expect to provide more details later this year.

Speaker Change: We will share a comprehensive package of these data with the FDA as part of our upcoming Interphase II meeting.

Speaker Change: we look forward to feedback from the fda on our unique and differentiation driven approach to a phase program designed for obesity

Scott Harris: We will provide an update on the outcome of this meeting when the dialogue with the FDA is complete. Turning to MASH, we presented data at the ESO Congress from a quantitative model that would predict a high likelihood of success in the upcoming impact trial. In addition, an analysis of data in our Phase I trial of metabolic-associated steatotic liver disease, also known as MASL-D, demonstrated that higher proportions of subjects receiving penvadutide achieved improvements in fibroscan aspartate immunotransferase, or FAST, score. P.E.D. vs. F.F.

Speaker Change: we will provide an update on the outcome of this meeting when the dialogue with the fda is complete

Speaker Change: Turning to MASH, we presented data at the ESO Congress from a quantitative model that would predict a high likelihood of success in the upcoming IMPACT trial.

Speaker Change: in addition and analysis of data in our phasal and trial of venabolic associated theootic liber disease also known as mass d

Speaker Change: Demonstrated that higher proportions of subjects receiving Pemvidutide achieved improvements in Fibroscan aspartate immunotransferase, or FAST, score.

Scott Harris: and alanine immunotransferase compared with subjects receiving placebo. This suggests that significant rates of MASH resolution and fibrosis improvement may be achieved in the MPAC Phase IIb MASH trial. We also presented data on the ability of pembidutide to lower serum lipid species associated with dyslipidemia in MASH, which reminds us that cardiovascular benefits are the primary cause of mortality in MASH patients. In addition, we recently published our results from a 12-week trial of Pemvidutide in Masel D, a metabolic-associated liver disease, in the Journal of Hepatology.

Speaker Change: M.R.I. P.E.D. F.F. and alanine immunotransferase compared with subjects receiving placebo.

Speaker Change: This suggests that significant rates of MASH resolution and fibrosis improvement may be achieved in the IMPACT Phase IIb MASH trial.

Speaker Change: we also presented dat on the ability of penpasdue to the lower car on lipid species associated with this liidim and mash which reminds us that cardiiovascular benefits of the primary cause of mortality in mash patients

Speaker Change: in addition we recently published our results from the twelve week trial of penddutide in maasald metabolic associated liber disease in the journal of eppattology establishing the differentiated effects append the due ide in the treatment of mal d and mash

Operator: Good day, ladies and gentlemen, and welcome to Altimmune Inc. 2nd quarter, 2024 Financial Results Conference call. 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.

Scott Harris: Establishing the Differentiated Effects of Pembidutide in the Treatment of Mazel-Dien Mash. The safety and tolerability profile of PEMPA-DU-TIDE was highlighted by the low 2.9% rate of adverse event discontinuations in this trial. With respect to impact, our enrollment is progressing well. If the 24-week efficacy endpoints are achieved, we believe the results could be transformative for the MASH therapeutic space, as we would demonstrate, for the first time, both rapid improvement in MASH resolution and fibrosis improvement with an incretin agent in a 24-week timeframe.

Speaker Change: The safety and tolerability profile of PEMPA-DU-TIDE was highlighted by the low 2.9% rate of adverse event discontinuations in this trial.

Speaker Change: With respect to impact, our enrollment is progressing well.

Lee Roth: I would like to introduce your host for today's conference call, Lee Roth, of Burns, McClellan, Investor Relations Advisors to Altimmune. Lee, you may begin. Thanks, Gigi. Good morning, everyone. Thank you for participating on the Altimmune 2nd quarter, 2024 Financial Results and Business Update Conference call. Members of the Altimmune team joining me today are Vip and Garg, our Chief Executive Officer, Scott Harris, our Chief Medical Officer, Ray George, our Chief Business Officer, Andrew Shutterly, our Acting Chief Financial Officer, and Scott Roberts, our Chief Scientific Officer.

Speaker Change: If the 24-week efficacy endpoints are achieved,

Speaker Change: we believe the results could be transformative for the not match therapeutic space

Speaker Change: As we would demonstrate for the first time, both rapid improvement in mass resolution and fibrosis improvement with an Incretin agent in a 24-week time frame.

Lee Roth: Following the prepared remarks from Vip and Scott Harris and Andrew, we'll hold the Q&A session. As a reminder, a press release with our Q2 to 2024 Financial Results was issued this morning and can be found on the IRS section of the Q&A 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 Security's litigation reform act of 1995. Altimmune cautions that these forward-looking statements are subject to risks and uncertainties that could cause our actual results to differ materially from those indicated.

Scott Harris: Finally, as we have discussed before, we are continuing to evaluate additional indications for Pembedutide that leverage the benefits of glucagon and that, we believe, will create additional value that will be attractive to strategic partners or allow us to develop on our own. We anticipate pursuing up to three additional indications for PEMDU-TIDE in our areas of greatest unmet medical need, and we expect to provide more details later this year.

Speaker Change: Finally, as we have discussed before,

Speaker Change: We are continuing to evaluate additional indications for PEMDA due time.

Speaker Change: that leverage the benefits of glucagon, and that, we believe, will create additional value.

Speaker Change: that will be attractive to strategic partners or allow us to develop on our own.

Speaker Change: we en visioned pursuing up to three additional indications for penda dutide in our areas of great unmet areas of greatest unmet medical need and we expect to provide more details later this year

Andrew Shutterly: With that, I'll now turn the call over to our Acting Chief Financial Officer, Andrew Shutterly, to review our financial results for the second quarter. Andrew? Thank you, Scott.

Andrew Shetterly: With that, I'll now turn the call over to our Acting Chief Financial Officer, Andrew Shetterly, to review our financial results for the second quarter. Andrew?

Andrew Shutterly: Thank you, Scott. And good morning again, everyone.

Scott Roberts: Thank you, Scott, and good morning again, everyone. On today's call, I'll be providing a brief update on Altimune's second quarter 2024 financial and operating results. More comprehensive information will be available in our Form 10-Q to be filed with the SEC later today. Approximately $14.8 million of this total for the second quarter of 2024 were direct expenses for the conduct of our clinical programs, including $13.8 million in direct costs related to development activities for PEMV-Dutide and $1 million in direct costs related to the wind-down and closing of the HEPTA cell, as announced on March 27, 2024.

Andrew Shutterly: For today's call, I'll be providing a brief update on Altimmune's second quarter 2024 financial and operating results. More comprehensive information will be available in our Form 10-Q to be filed with the SEC later today. Altimmune ended the second quarter of 2024 with approximately $164.9 million of cash, cash equivalents, and short-term investments, compared to $198 million at the end of 2023. We project that our existing balance will fund us into the first half of 2026, which fully funds our impact trial and match, including the expected Q1 2025 readout of top-line biopsy data. Turning to the income statement, revenue was negligible in the second quarter of 2024 and 2023. Any revenue reported during that period was for indirect rate adjustments on a government contract that we're closing out.

Andrew Shetterly: Thank you, Scott, and good morning again, everyone. For today's call, I'll be providing a brief update on Altimune's second quarter 2024 financial and operating results. More comprehensive information will be available in our Form 10-Q to be filed with the SEC later today.

Lee Roth: For discussion of some of the risks and the factors that could impact the company's future results and operations, please refer to the risk factors and other cautionary statements contained in our filings with the SEC. I'll also direct you to read the forward-looking statement disclaimer in our press release issued earlier today and now available on our website. Any statements made during this call speak only as of today's date Thursday, August 8, 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. As a reminder, this call is being recorded and will be available for audio replay on the Altimmune website.

Speaker Change: Altamian ended the second quarter of 2024 with approximately $164.9 million dollars of cash, cash equivalents, and short-term investments.

Speaker Change: compared to one hundred and ninety eightmillion dollars at the end of two thousand and twenty three

Scott Roberts: we project that our existing balance will fund us into the first half of two thousand and twenty six which fully fund our impact trial and mash including the expected q one two thousand and twenty five readout of top line biopsed data

Speaker Change: Turning to the income statement, revenue was negligible in the second quarter of 2024 and 2023. Any revenue reported during such period was for indirect rate adjustments on a government contract that we're closing out.

Vipin Garg: With that, it's now my pleasure to turn on the call over to Dr. Vipengarg, Chief Executive Officer of Altimmune Vipeng. Thanks, Lee. Good morning, everyone, and once again, thank you for joining us for our second quarter corporate update. In the second quarter and throughout the first half of the year, we continued to strengthen the rationale for Pemberview Tide as a highly differentiated therapeutic with significant potential in a variety of metabolic diseases.

Andrew Shutterly: Research and development expenses were $21.2 million in the second quarter of 2024, compared to $13.3 million in the same period of 2023. Approximately $14.8 million of this total for the second quarter of 2024 were direct expenses for the conduct of our clinical programs, including $13.8 million in direct costs related to development activities for PEMV-Dutide and $1 million in direct costs related to the wind-down and closing of heptacell, as announced on March 27, 2024.

Scott Roberts: Research and development expenses were $21.2 million in the second quarter of 2024, compared to $13.3 million in the same period in 2023.

Speaker Change: approximately fourteen point eight million dollars of this total for the second quarter of two thousand andtwenty four were direct expenses for the conduct of our clinical programs

Vipin Garg: We are continuing to advance our key strategic clinical and operational priorities that are excited for the milestones that are approaching in both our obesity and mass programs. The quarter was highlighted by important data presentations at two of the most prominent medical meetings in our space. The American Diabetes Association, or ADA's 84th Scientific Sessions, and the European Association for the Study of the Liver or Easel Congress, at the ADA meeting in June, we presented updated data on the effects of Pemby Dutide on body composition from our phase two momentum obesity trial that demonstrated a class leading preservation of lean mass among incredible agents.

Scott Roberts: including $13.8 million in direct costs related to development activities for PEMV-Dutide and $1 million in direct costs related to the wind-down and closing of hepatocell, as announced on March 27, 2024.

Scott Roberts: R&D expenses in the second quarter of 2023 included $5.6 million in direct expenses associated with the development of Penvidutide and $1.8 million in direct expenses related to heptocell development activities. I'll now turn it back over to Vipin for his closing remarks.

Andrew Shutterly: R&D expenses in the second quarter of 2023 included $5.6 million in direct expenses associated with the development of PEMV dutide and $1.8 million in direct expenses related to heptocell development activities. General and administrative expenses were $5.6 million in the second quarter of 2024 versus $4.8 million in the second quarter of 2023. The increase was due primarily to a $1 million increase in stock compensation expense caused by the modification of stock awards, partially offset by a $0.3 million reduction in insurance expenses.

Scott Roberts: R&D expenses in the second quarter of 2023 included $5.6 million in direct expenses associated with the development of PEMV dutide and $1.8 million in direct expenses related to heptocell development activities.

Scott Roberts: General and administrative expenses were $5.6 million in the second quarter of 2024 versus $4.8 million in the second quarter of 2023.

Speaker Change: the increase was due primarily to a one million dollar increase in stock compensation expense caused by the modification of stock awards partially offset proby a zero point three million dollar reduction in insurance expenses

Andrew Shutterly: Our quarterly non-cash operating expenses for the second quarter of 2024 were $4.4 million, all of which were recurring expenses. The net loss for the three months ended June 30, 2024, was $24.6 million, or $0.35 net loss per share, compared to a net loss of $16.1 million, or $0.32 net loss per share, for the second quarter of 2023. The increase in net loss in the quarter is primarily attributable to the $7.9 million increase in research and development expenses as we continue to execute the IMPACT Phase 2b trial in March. I'll now turn it back over to Vipin for his closing remarks.

Vipin Garg: Preservation of lean mass and the quality of weight loss is becoming increasingly important for the treatment of obesity and for the safety and long-term maintenance of weight loss. In addition, we presented data during the easel congress that highlighted the disease modifying potential of Pemby Dutide in mass and reinforces our confidence in achieving both the mass resolution and fibrosis endpoint in our phase two B impact trial. We remain engaged in discussions regarding a global strategic transaction for Pemby Dutide involving a variety of possible structures.

Scott Roberts: Our quarterly non-cash operating expenses for the second quarter of 2024 was $4.4 million, all of which were recurring expenses.

Speaker Change: net lo for the three months ended june thirty two thousand and twenty four was twenty four point six million dollars or a thirty five percent net loss per share compared to a net loss of sixteen point one million dollars or thirty two cent net loss per share for the second quarter of two thousand and twenty-three

Vipin Garg: We are intently focused on identifying and securing a partner with the right vision, resources, and commitment to help us realize the full potential of Pemby Dutide in obesity, mass, and other metabolic conditions. In parallel, we intend to create additional value by completing the impact study and pursuing additional indications for which Pemby Dutide is specially well suited. Finally, we continue to prepare for the end of phase two meeting with the FDA to review our registration of program for obesity. The outcome of this meeting will confirm the patient population we believe will benefit most from the differentiated profile of Pemby Dutide.

Vipin Garg: We are optimistic about the next steps for PEMI-DUTAI and are looking forward to the opportunities that lie ahead. With multiple upcoming milestones, we believe that we are well positioned for an exciting second half of the year and early 2025. Operator, that concludes our formal remarks.

Vipin Garg: We are optimistic about the next steps for Family Due Tide and are looking forward to the opportunities that lie ahead. With multiple upcoming milestones, we believe that we are well positioned for an exciting second half of the year and early 2025. Operator, that concludes our formal remarks. And we would like to open the lines to take questions. Thank you.

Operator: Thank you. As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. Our first question comes from Yasmeen Rahimi on behalf of Piper Sandler.

Scott Harris: With that, I've now done the call over to our chief medical officer, Dr. Scott Harris, to provide additional updates and discuss our plans. Scott, thank you, Vipin. To provide a bit more information at some of the points we discussed, I'd like to turn to the data presented at recent scientific meetings. At the ADA meeting, Dr. Lu Aroni, one of the foremost experts in obesity and metabolic disease, and principal investigator in our momentum obesity trial, presented data showing that Pemby Dutide led to nearly 16 percent weight loss at 48 weeks, with the direct trajectory suggesting additional weight loss with continued treatment.

Operator: Our first question comes from the line of Yasmeen Rahimi from Piper Sandler.

Speaker Change: Our first question comes from the line of Yasmin Rahimi from Piper Sandler.

Liam Hiester: Hi, this is Liam Hiester on for YAS. Just a few quick questions. So the first one, if you could kindly talk about the response rate in fibrosis and mass resolution that you believe to be competitive in the mass space. Secondly, what are your expectations for the dose response across the 1.2 milligram to 1.8 milligram range for biopsy endpoints? And then third, going into the end of phase two meeting with the FDA, what are some key questions you plan to discuss with them? And if you can provide any color on which patient population you are considering for phase three, that would be great.

Operator: Hi, This is Liam Easter on for jazz.

Yasmeen Rahimi: Just a few quick questions. The first one if you could kindly talk about the response rate in <unk>.

Speaker Change: <unk> and Nash resolution that you believed to be competitive in the mass space.

Scott Harris: Dr. Aroni also presented updated body composition analyses that showed class-leading preservation of lean mass among Inkerton agents, with only 21.9 percent of weight loss attributed to lean mass, while 78.1 percent of weight loss was associated with fat loss. Available data on other Inkerton-based weight loss agents have shown that lean mass loss can account for as much as 40 percent of the total weight loss. That the preservation of lean mass is becoming an increasingly important consideration in the management of obesity, as loss of lean mass has been associated with higher rates of bone fractures.

Operator: Secondly.

Yasmeen Rahimi: What are your expectations for that dose response across the one two milligram to one eight milligram dosing for biopsy endpoint and then going into the end of phase II meeting with the FDA. What are some key question you plan to discuss with them and if you could provide any color on which patient population.

Yasmeen Rahimi: That would be great.

Leon: Well, thanks for the questions, Leon. Regarding the response rates for fibrosis and MASH resolution... It really depends on the placebo response that you see. So if you have a 30% placebo response, you're going to see a much, expect a much higher rate of, say, match resolution or fibrosis improvement. And consequently, with a low placebo response rate, you'd expect a lower one. So to actually talk about response rates is difficult in that setting.

Operator: Okay.

Scott Harris: Hess. Well, thanks for the questions, Leon. So, regarding the response rates for fibrosis and MASH resolution... It really depends on the placebo response that you see. So if you have a 30% placebo response, you're going to see a much, expect a much higher rate of, say, match resolution of fibrosis improvement. And consequently, with a low placebo response rate, you'd expect a lower rate. So to actually talk about response rate is difficult in that setting.

Scott Harris: Scott Harris.

Leon: Well thanks for the questions. So regarding the response rates for fibrosis and Nash resolution.

Leon: It really depends on the placebo response that you see so if you have a 30% placebo response youre going to see a much expect a much higher rate.

Leon: Same nash resolution or fibrosis improvement and consequently, with a low placebo response rate you would expect are lower so to actually talk about response rates.

Leon: Is difficult in that setting.

Scott Harris: Even looking at the delta over placebo really depends on where you start, as I just mentioned. The most important thing is that statistical significance is achieved. And I believe that we'll see not only statistical significance but meaningful response rates from both endpoints. Regarding your second question on dose response, in MASH, In the impact trial, we believe that the 1.8 milligram dose will be the superior dose, the same as we saw the dose response in the Momentum trial.

Leon: Even looking at the delta over placebo really depends on where you start. And I believe that we'll see not only statistical significance, but meaningful response rates from both endpoints in MASH. In the impact trial, we believe that the 1.8 milligram dose will be the superior dose, the same as we saw the dose response in the Momentum trial. And to remind you, Lastly, regarding the end of phase two meeting, the key questions that we're asking the FDA are about our study design, which we intend to bring out the differentiated profile of pentazutide on lipids, liver fat, and body composition because we believe that this will differentiate pentazutide in the marketplace. So, we are constructing.

Leon: Even looking at the Delta over placebo really depends on where you start.

Scott Harris: Lewis, Reduce Physical Function, and Mortality. The data presented at ADA also demonstrated that Pemphidutide has pronounced effects and serum lipids associated with cardiovascular risk. In a subset of subjects with dyslybidemia, Pemphidutide treatment led to a 55.8% reduction in triglycerides, 20% reduction in total cholesterol, and 17.4% reduction in LDL cholesterol at the 2.4 milligram dose. Since dyslybidemia affects as many as 70% of obesity patients, we believe that Pemphidutide could benefit a significant segment of the obesity population.

Leon: As I just mentioned the <unk>.

Leon: Most important thing is that statistical significance is achieved and I believe that we will see not only statistical significance, but meaningful response rates in both endpoints regarding.

Speaker Change: Regarding your second question on the dose response.

Leon: And mash and the impact trial, we believe that will be one eight milligram dose will be the superior dose same as we saw the dose response in the.

Scott Harris: And to remind you that the end point in MASH is driven predominantly by reduction in liver fat, and the reduction in liver fat at the 1.8 milligram dose was substantially higher than the reduction at the 1.2 milligram dose, and we think that the end point in the mass trial will follow that same pattern as well. Lastly, regarding the end of phase two meeting, the key questions that we're asking the FDA are about our study design, which we intend to bring out the differentiated profile of pembidutide on lipids, liver fat, and body composition, because we believe that this will differentiate pembidutide in the marketplace.

Leon: Momentum trial and to remind you.

Speaker Change: The endpoints.

Speaker Change: And mash are driven predominantly by a reduction in liver fat and the reduction in liver fat at the one eight milligram dose was substantially higher than the reduction of the one two milligram dose and we think that the endpoints in the mass trial will follow that same pattern as well.

Scott Harris: While significant cardiovascular benefits of weight loss were observed with GLP monotherapy in the recent select trial, the effects on lipids were not clinically meaningful. We believe that with the robust reductions of serum lipids and liver fat observed with Pemphidutide, we can achieve even greater degrees of cardiovascular benefit in this population. The narrative in the obesity space is evolving towards higher quality weight loss, safe and effective maintenance of weight loss, and the ability to directly address the comorbidities associated with obesity.

Leon: Lastly, regarding the end of phase II meeting the key questions that we're asking the FTA.

Leon: Sure.

Leon: About our study design, which we intend to bring out the differentiated profile of <unk>.

Leon: Lipids liver fat and body composition, because we believe that this will differentiate <unk> in the marketplace. So we are constructing.

Scott Harris: So we are constructing our end of phase 2 program and phase 2 interaction with the FDA in the phase 3 program to basically bring out a target product profile that will be commercially attractive and very differentiating from the other compounds in the space.

Leon: Our.

Speaker Change: And the phase III program.

Scott Harris: We believe that Pemphidutide with its excellent preservation of liver mass and its robust reductions in serum lipids and liver fat is well positioned compared with other agents. We will share a comprehensive package of these data with the FDA as part of our upcoming end-of-phase to a meeting. We look forward to feedback from the FDA on our unique and differentiation driven approach to a phase 3 program designed for obesity. We will provide an update on the outcome of this meeting when the dialogue with the FDA is complete.

Leon: Phase III interaction with the FDA in the phase III program to basically bring out a target product profile that will be commercially attractive and very differentiating from the other compounds in this space.

Leon: Thank you.

Operator: One moment for our next question, which comes from the line of Roger Song from Jeffreys.

Speaker Change: One moment for our next question.

Roger Song: Our next question comes from the line of Roger song from Jefferies.

Roger: Morning team, this is Combizone for Roger. Thanks for the questions. Maybe following up on endpoints for your potential phase 3 program, you discussed body fat, lipids, and liver. How are some ways you could differentiate or measure those endpoints in a way that is more nuanced or detailed than other companies can? And then, secondly, on potential partnerships, what are some attractive collaboration structures you're exploring? And at this point, your match results and all factors into those partnerships.

Roger Song: Morning, team. This is Combizone for Roger.

Speaker Change: This is <unk> on for Roger Thanks for the questions maybe.

Roger: Maybe following up on.

Scott Harris: Turning to MASH, we presented data at the ESO Congress from a quantitative model that would predict the high likelihood of success in the upcoming impact trial. In addition, an analysis of data in our phase 1 trial of metabolic associated, it is the Atotic Liver Disease, also known as Massal D, demonstrated the higher proportions of subjects receiving Pemphidutide, achieved improvements in fiber scan aspartate, immunotransferase, or FAST score, MRI, PDFF, and Allen immunotransferase, compared with subjects receiving placebo.

Speaker Change: Endpoints for a potential phase III program.

Roger: Discuss body fat lipids and liver.

Roger Song: Thanks for the questions. Perhaps following up on endpoints for your potential phase three program, you discussed body fat, lipids, and liver. How are some ways you could differentiate or measure those endpoints in a way that is more nuanced or detailed than other companies can? And then, secondly, on potential partnerships, what are some attractive collaboration structures you're exploring? And at this point, do your match results at all factor into those partnerships?

Speaker Change: Power some ways you can differentiate our measure those.

Roger: Endpoints in a way that.

Speaker Change: Our more nuance are detailed in other companies can.

Speaker Change: And then secondly.

Speaker Change: Perhaps on potential partnerships, what are some attractive collaboration structure as youre exploring.

Speaker Change: And at this point to year match results at all factor into those partnership discussion. Thank you.

Scott Harris: Thanks, Kambi. I'll take the first question about the endpoints of the Phase III trial, and I'll ask Vipin to answer the second question about the collaboration. So, you know, we think that the endpoints are fairly clear because they represent meaningful clinical changes. For example, serum lipids are a clear surrogate for cardiovascular risk. And there's been a very strong association of liver fat with not only cardiovascular outcomes but outcomes in a variety of other organs, such as the kidney.

Kambi: Thanks Kambi. I'll take the first question about the endpoints of the phase 3 trial, and I'll ask Vipin to answer the second question about the collaboration, either approved or in development, and we think that's extremely important as a stand-alone because the loss of lean mass has been associated with loss of physical function, fractures, and also, in some cases, mortality. Many of these endpoints would take far larger trials to demonstrate, but we believe that they stand on their own as surrogates and are clinically meaningful. Vipin?

Roger: Thanks, Colby I'll take the first question about the endpoints of the phase III trial in all S victims.

Operator: Thank you. Thank you. One moment for our next question. Thank you.

Scott Harris: This suggests that significant rates of MASH resolution and fibrosis improvement may be achieved in the impact phase 2B MASH trial. We also presented data on the ability of Pemphidutide to lower serum lipids species associated with this lipidemia in MASH, which reminds us that cardiovascular benefits are the primary cause of mortality in MASH patients. In addition, we recently published our results from the 12-week trial of Pemphidutide in Massal D metabolic associated liver disease in the Journal of Hepatology, establishing the differentiated effects of Pemphidutide in the treatment of MASH and MASH.

Vipin Garg: To answer the second question about the collaborations.

Vipin Garg: So we think that the endpoints are fairly clear because they represent.

Speaker Change: I mean meaningful clinical changes.

Speaker Change: For example, serum lipids are clear circuit for cardiovascular risk and there has been a very strong association of liver fat with not only cardiovascular outcomes, but outcomes in a variety of other organs such as the kidney.

Scott Harris: So we believe that simply demonstrating improvement of those endpoints will be very meaningful. As we mentioned, we also have class-leading preservation of lean mass among Incretin agents, either approved or in development, and we think that's extremely important as a stand-alone because the loss of lean mass has been associated with loss of physical function, fractures, and also, in some cases, mortality. Many of these endpoints would take far larger trials to demonstrate, but we believe that they stand on their own as surrogates and are clinically meaningful. Vipin? Yeah, so we did

Operator: So.

Speaker Change: We believe that simply demonstrating improvement of those endpoints will be very meaningful.

Scott Harris: Bush, The Safety and Tolerability Prof. Pempiduteide was highlighted by the low 2.9% rate of adverse event discontinuations in this trial. With respect to impact, our enrollment is progressing well. If the 24-week efficacy endpoints are achieved, we believe the results could be transformative for the MASH therapeutic space. As we would demonstrate, for the first time, both rapid improvement in MASH resolution and fibrosis improvement with an Incherton agent in a 24-week time frame.

Operator: We.

Speaker Change: We mentioned, we also have class leading.

Vipin Garg: Preservation of lean mass among the anchor 10 agents.

Operator: Either approved or in development and we think that's extremely important as a stand alone.

Operator: Cause the loss of lean mass has been associated with loss of physical function fractures and also in some cases mortality.

Operator: Many of these endpoints would take far larger trials to demonstrate but we believe that they stand on their own as circuits and are clinically meaningful.

Vipin Garg: Yeah, so with regard to the structure, I can't really get into the specific details of the structures, but, you know, we are open to multiple different structures. The focus is to get full value for the asset. As you know, Family Dutide is basically a pipeline in a product. We have got two major indications that we are pursuing, so we want to make sure we are able to capture the upside on both of those indications. So, you know, there are so many different ways to capture that value and structure the deal so we are able to get full value for the asset.

Operator: <unk>.

Speaker Change: Yes, so with regards to the structure I can't really get into the specific details of the structure, but we are open to multiple different structures.

Scott Harris: Finally, as we have discussed before, we are continuing to evaluate additional indications for Pempiduteide that leverage the benefits of Bluekegon and that we believe will create additional value that will be attractive to strategic partners or allow us to develop on our own. We envision pursuing up to three additional indications for Pempiduteide in our areas of great unmet, areas of greatest unmet medical need. And we expect to provide more details later this year.

Speaker Change: The focus is to get full value for the asset as you know.

Vipin Garg: Family do Digest basically pipeline in a product we have got two major indications that we're pursuing so we want to make sure we are able to capture the upside on both of those indications.

Vipin Garg: There are so many different ways due to capture that value and structure of the deal. So we're able to get full value for the asset.

Andrew Shutterly: With that, I will now turn the call over to our Acting Chief Financial Officer Andrew Shutterly to review our financial results for the second quarter. Andrew? Thank you, Scott. Good morning again, everyone. For today's call, I will be providing a brief update on Altimmune's second quarter, 2024 financial and operating results. More comprehensive information will be available in our Form 10Q to be filed at the SEC later today. Altimmune ended the second quarter of 2024 with approximately $164.9 million of cash equivalent in short-term investments, compared to $198 million at the end of 2023.

Speaker Change: Thank you.

Operator: One moment for our next question.

Operator: Thank you. One moment for our next question. Our next question comes from the line of Seema Chauran from Evercore.

Operator: Our next question comes from the line of Cmos Shuren from Evercore.

Andrew Shutterly: We project that our existing balance will fund us into the first half of 2026, which fully fund our impact trial and match, including the expected Q1 2025 readout of top line biopsy data. Turning to the income statement, revenue was negligible in the second quarter of 2024 and 2023. Any revenue reported during such period was for indirect rate adjustments on a government contract that we're closing out. Research and development expenses were $21.2 million in the second quarter of 2024, compared to $13.3 million in the same period in 2023.

Seema Chauran: Hi, this is Seema. I'm for Liisa.

Speaker Change: Hi, This is <unk> on for Lisa. Thank you for taking my question.

Seema Chauran: Thank you for taking my question. As we are expecting Phase 2 NASH data in the first quarter, can you expand on how the enrollment is going and when you expect it to be complete? And my second question is on oral and videotite. You have mentioned that you plan to announce a candidate by year end. Is that still the case?

Speaker Change: As you would expecting phase two Nash data in third quarter can you expand on like how the enrollment is going and.

Operator: When you expect it to be complete. And my second question is on oral and video conferencing. You have mentioned that you plan to announce a candidate by year end. Is that still the case?

Speaker Change: When do you expect it to be complete.

Speaker Change: My second question is on <unk> you.

Speaker Change: You have mentioned that you plan to announce candidate by year end is that in the case and what are some of the.

Operator: And what are some of the, you know, like, characteristics of this candidate that you are looking for? Thank you.

Seema Chauran: And what are some of the characteristics of this candidate that you are looking for? Thank you.

Operator: Characteristics of this candidate.

Operator: That you are looking for thank you.

Seamus Fernandez: Thanks, Seamus. I'll answer the first question. I'll ask Scott Roberts to address the oral candidates.

Scott Harris: Thanks, Seamus. I'll answer the first question.

Scott Roberts: So enrollment is going extremely well. We've been told that we're enrolling this trial faster than any other mass trial, and that shows the fact that the trial is attractive to patients because of the weight loss that it offers. So screening has not been a problem. We do intend to complete screening in the near future, and then we can provide you with an update on the estimated date of the announcement of the trial results, which we still believe will be in the first quarter of 2025.

Scott Roberts: I'll ask Scott Roberts to address the oral candidates. So enrollment is going extremely well. We've been told that we're enrolling this trial faster than any other mass trial, and that shows the fact that the trial is attractive to patients because of the weight loss that it offers. So screening has not been a problem. We do intend to complete screening in the near future. And then we can provide you with an update on, you know, the estimated date of the announcement of the trial results, which we still believe will be in the first quarter of 2025. Scott, did you want to address the question about the oral formulation? Sure.

Seamus Fernandez: Candidates.

Speaker Change: So enrollment is going extremely well.

Scott Roberts: We've been told that we're enrolling this trial faster than any other mass trial and that represents the fact that the trial is attracted to patients because of the.

Scott Roberts: The weight loss that it offers so screening has not been a problem. We do intend to complete screening in the near future and then we can provide you an update on.

Andrew Shutterly: Approximately $14.8 million of this total for the second quarter of 2024 were direct expenses for the conduct of our clinical programs, including $13.8 million in direct costs, related to development activities for PEMVU tied, 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 second quarter of 2023 included $5.6 million in direct expenses associated with the development of PEMVU tied in $1.8 million in direct expenses related to Hepticel development activities.

Scott Roberts: The estimated date of the.

Scott Roberts: Announcement of the trial results, which we still believe we'll be in the first quarter of 2025.

Scott Roberts: Scott did you want to.

Speaker Change: Address the question about the oral formulation.

Scott Roberts: Sure. Good morning, Seamus.

Simo: Sure Good morning Simo.

Speaker Change: And thanks for thanks for the question your efforts on the oral formulation are continuing we've actually expanded the number of.

Speaker Change: Types of formulations that we're looking at and.

Scott Roberts: Prototype formulations.

Scott Roberts: We're still hopeful that we can.

Andrew Shutterly: General administrative expenses were $5.6 million in the second quarter of 2024, versus $4.8 million in the second quarter of 2023. The increase was due primarily to a $1 million increase in stock compensation expense, caused by the modification of stock awards, partially offset by a $0.3 million reduction in insurance. Expenses. Our quarterly non-cash operating expenses for the second quarter of 2024 was $4.4 million all of which were recurring expenses. Net loss for the three months ended June 30, 2024 was $24.6 million or a 35 cent net loss per share compared to a net loss of $16.1 million or a 32 cent net loss per share for the second quarter of 2023. The increase in that loss in the quarter is primarily attributable to the $7.9 million increase in research and development expenses as we continue to execute the impact phase to the trial and mash.

Scott Roberts: All of these formulations for formal development by that by the end of the year.

Scott Roberts: I think that.

Scott Roberts: The oral formulations is an important point.

Speaker Change: Thank you William.

Speaker Change: And is that success with penalty due tied the peptide is no formulation.

Speaker Change: It's really cool.

Scott Roberts: We're seeing with the small molecule oral <unk>.

Speaker Change: Emulation switching or obviously are working.

Speaker Change: But the amount of weight loss and the overall potency the adverse event profile.

Speaker Change: <unk> is well established.

Scott Roberts: and an oral formulation that delivers the peptide into the blood at equivalent concentrations to what we have further advanced.

Scott Roberts: And thanks for the question. Our efforts on the oral formulation are continuing. We've actually expanded the number of types of formulations that we're looking at, prototype formulations. We're still hopeful that we can nominate one of these formulations for formal development by the end of the year.

Scott Roberts: <unk>, an oral formulation that delivers the peptide into.

Scott Roberts: Into the blood equivalent.

Scott Roberts: Concentrations to work.

Scott Roberts: I think that in oral formulations, there's an important point. I do want to think that the success with Pemvy Dutide shows that the peptide as an or formulation is really good. We're seeing with the small molecule oral formulations, which are obviously working. But the amount of weight loss and the overall potency, the adverse event profile of an underdue diet is well established, and an oral formulation that delivers the peptide into the blood at equivalent concentrations to what we do. So we're really very differentiated with respect to small molecules, which are clearly active but not really pushing the levels of weight loss that you see with subcutaneous peptides and also have higher rates of adverse events, as you know. So we The goal is to achieve a pen-butyte-like clinical profile with the oral formulation. So we'll update you as we know more further.

Speaker Change: The Atlanta the same profile. So we're really very differentiated with respect to small molecules.

Scott Roberts: <unk>.

Speaker Change: Clearly active but not really pushing the levels of weight loss.

Speaker Change: You see with that with the subcutaneous peptides.

Speaker Change: And also have higher rates of adverse events as you know so.

Vipin Garg: I'll now turn it back over to Vipin for his closing remarks. Vipin? Thank you, Andrew.

Scott Roberts: We still think this project is extremely valuable.

Vipin Garg: We are optimistic about the next steps for Pemberview Tide and are looking forward to the opportunity that lie ahead. With multiple upcoming milestones, we believe that we are well positioned for an exciting second half of the year and early 2025.

Speaker Change: So as to achieve a penalty type like.

Scott Roberts: Clinical profile with the oral formulation.

Scott Roberts: So we'll update you as we know.

Scott Roberts: Further.

Scott Roberts: It answers there.

Operator: Operator that concludes our formal remarks and we would like to open the lines to take questions. Thank you.

Speaker Change: Thank you one moment for our next question.

Operator: Thank you. Thank you. One moment for our next question. Our next question comes from the line of Corinne Johnson from Goldman Sachs.

Speaker Change: Our next question comes from the line of Corin Johnson from Goldman Sachs.

Operator: As a reminder to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster.

Omari Baruti: Good morning, this is Omari on behalf of Corinne, so we have a couple questions.

Corinne Johnson: Good morning, this is Omari on behalf of Corinne, so we have a couple questions. In the past, you wanted to establish a partnership prior to seeking regulatory approval. Does that remain an aim, and how would you think about executing against the next steps as provided by the agency after the partner? And then second, what is your wish list as you approach the agency for alignment at the end of phase two meeting and prepare for future studies?

Scott Roberts: Good morning, this is omar.

Omari Baruti: So we have a couple of questions.

Operator: I'm sorry, can you repeat your first question?

Amy: In the past you want to establish a partnership prior to seeking regulatory approval is that remaining Amy how would you think about executing against your next steps that's been running around the agency actually had a partner.

Omari Baruti: And then okay. What is your wish list as you approach the agency for a margin call and into phase two meeting and prepare for future studies.

Liam Hiester: Our first question comes from the line of Yasmin Rahimi from Piper Sandler. Hi, this is Liam Heaster on for Yas. Just a few quick questions. The first one, if you could kindly talk about the response rate and cyber assistance and mass resolution that you believe to be competitive in the mass space. Secondly, what are your expectations for the dose response across the 1.2 milligram to 1.8 milligram dozing for biopsy endpoints? Then third, going into the end of phase 2 meeting with the FDA. What are some key questions you plan to discuss with them? And if you could provide any color on which patient population you are considering for phase 3, it would be great.

Omari Baruti: I'm sorry can you repeat your first question.

Corinne Johnson: Sure. In the past, you wanted to establish a partnership prior to seeking regulatory approval. Does that remain an aim? And how would you want to think about executing against next steps provided by the agency without a partnership?

Omari Baruti: Sure. So in the past you would have wanted to establish a partnership prior to seeking regulatory approval.

Omari Baruti: And then how would you want to think about equity against next steps provided by the agency with Counterparties.

Omari Baruti: Okay, I got it. So sorry.

Operator: Okay, I got it. So sorry.

Omari Baruti: Okay I got it sorry, so in terms of partnership prior to approval I mean look our goal has always been to have a partner lined up before we start the phase III development in obesity in mash. Its a different story, we think we can take it forward on our own and mash and part of the reason we're looking at.

Vipin Garg: So in terms of partnership prior to approval, I mean, look, our goal has always been to have a partner lined up before we start the phase three development in obesity.

Vipin Garg: So in terms of partnership prior to approval, I mean, look, our goal has always been to have a partner lined up before we start the phase three development in obesity. In MASH, it's a different story. We think we can take it forward on our own in MASH. And part of the reason we are looking at these additional indications is that it gives us additional flexibility, even in obesity-related indications. So we'll see what feedback we get from the FDA at the end of phase two, as well as other interactions planned with the FDA to discuss the additional indications that we are evaluating. And once we have that information, we'll be able to make a better decision as to how to move forward.

Speaker Change: These additional indications that gives us additional flexibility even in even in obesity related indications. So we'll see what.

Vipin Garg: Well, thanks for the questions, Leon. So regarding the response rates for fibrosis and mass resolution, it really depends on the placebo response that you see. So if you have a 30% placebo response, you're going to see a much expected much higher rate of, say, mass resolution of fibrosis improvement and consequently, with a low placebo response rate, you'd expect a lower. So to actually talk about response rates is difficult in that setting.

Speaker Change: The feedback we get from the FDA at the end of Phase II meeting as well as we have other interactions plan with the FDA to discuss.

Speaker Change: The additional indications that we're evaluating and once we have that information, we'll be able to make a better decision as to how to move forward.

Scott Harris: I'm Ray. This is Scott. I'm going to ask you to repeat the second question because I didn't hear it. Yeah, the audio quality wasn't very good. Could you please repeat the question?

Vipin Garg: I'm sorry. This is Scott I'm going to ask you to repeat the second question because I didn't hear it.

Speaker Change: Audio quality wasn't good enough could you please repeat the question.

Vipin Garg: Sure. What is your wish list as you approach the agency for alignment at and in the Phase 2 meeting and prepare for future studies?

Operator: Sure. What is your wish list as you approach the agency for alignment at and in the Phase 2 meeting and prepare for future studies?

Speaker Change: Sure what is your wish list as you approach the agency for alignment.

Vipin Garg: Even looking at the delta over placebo really depends on where you start, as I just mentioned. The most important thing is that statistical significance is achieved. And I believe that we'll see not only statistical significance, but meaningful response rates from both endpoints. Regarding your second question on the dose to respond. Williams, in MASH, in the impact trial, we believe that the 1.8 milligram dose will be the superior dose, same as we saw the dose response in the momentum trial and to remind you that the endpoints in MASH are driven predominantly by reduction in liver fat, and the reduction in liver fat at the 1.8 milligram dose was substantially high.

Vipin Garg: The phase II meeting and prepare for future states.

Scott Harris: Well, I think this was partially addressed previously. Um, so we believe that we have a highly differentiated compound. We believe that the obesity marketplace is going to segment with different patient needs. We stress repeatedly that 70% of the marketplace is dyslipidemic or high liver fat. Consequently, rather than saying, "You know, this is a program for the treatment of obesity," we're going to highlight that this is a program for the treatment of subjects with obesity who have high serum lipids.

Speaker Change: Well I think this was partially addressed previously.

Speaker Change: So we.

Vipin Garg: We believe that we have a highly differentiated compound.

Speaker Change: We believe that the obesity marketplace is going to segment with different patient needs, we stress repeatedly that 70% of the marketplace.

Vipin Garg: We stress repeatedly that 70% of the marketplace. Consequently, rather than saying, we are focusing on the key attributes of pemvidutide that create our target product profile, which we will use to commercialize the compound, and we think that differentiation

Vipin Garg: As dyslipidemia or high liver fat.

Vipin Garg: So consequently.

Vipin Garg: Rather than saying.

Speaker Change: This is a program for the treatment of obesity.

Speaker Change: To highlight that this is a program for the treatment of subjects with obesity with high serum lipids high liver fat, but also people who might be subject to the effects of excess of lean muscle loss.

Vipin Garg: And we think that the endpoints in the MASH trial will follow to that same pattern as well. Lastly, regarding the end of phase two meeting, the key questions that we're asking the FDA are about our study design, which we intend to bring out the differentiated profile of PEMF as you taught on lipids, liver fat, and body composition. Because we believe that this will differentiate PEMF the due type in the marketplace. So we are constructing our end to phase two program and in phase two interaction with the FDA and the phase three program to basically bring out a target product profile that will be commercially attractive and very differentiating from the other compounds in the space. Thank you.

Scott Harris: High Liver Fat, and also people who might be subject to the effects of excessive lean muscle loss. So what differentiates our end of phase two discussion from others that may have preceded it is that we're not going in and saying this is an approval for obesity. We're saying this is an approval for obesity, focusing on the key attributes of pemvidutide that create our target product profile, which we will use to commercialize the compound. And we think that differentiation will be attractive in the marketplace but for potential partners as well.

Operator: One moment for our next question.

Vipin Garg: No.

Vipin Garg: What differentiates our end of phase two discussion.

Speaker Change: From others that may have preceded it is that we're not going in and saying this is an approval for obesity.

Speaker Change: We're saying this is an approval for obesity.

Vipin Garg: Focusing on the key attributes of <unk> that create our target product profile, which we will use to commercialize the compound and we think that differentiation.

Vipin Garg: We'll not only be attractive in the marketplace, but for potential partners as well.

Operator: Thank you. One moment for our next question. Our next question comes from the line of Mayank Mamtani from B. Riley Security.

Speaker Change: Thank you one moment for our next question.

Speaker Change: Our next question comes from the line of my Yang Mom Tani from B Riley Securities.

William Owen: Hi, thanks so much. This is actually William Owen from IUNC.

Mayank Mamtani: Hi. Thanks so much. This is actually William Owen from IUNC.

Vipin Garg: Hi, Thanks, so much this is actually William on for my own.

Speaker Change: Congratulations on the nice quarter, just a couple of questions from us the <unk>.

William Owen: Congratulations on a nice quarter. Just a couple questions from us. The first is, I'm just kind of curious about the discontinuation rate variance that you've seen from prior phase two trials, whether it be, you know, in momentum and diabetes, maybe even in your earlier NAFLD trial. Where are you expecting to land in your phase two impact trial and maybe what you've been seeing so far?

Mayank Mamtani: Congratulations on a nice quarter. Just a couple questions from us. The first is, I'm just kind of curious about the discontinuation rate variance that you've seen from prior Phase II trials, whether it be, you know, in momentum and diabetes, maybe even in your earlier NAFLD trial. Where are you expecting to land in your Phase II impact trial and maybe what you've been seeing so far?

Roger Song: Our next question comes from the line of Roger Song from Jeffries. One thing this is conduz on for Roger. Thanks for the questions.

William Owen: I'm just kind of curious about the discontinuation rate variance that you've seen from prior phase III trials.

William Owen: B.

William Owen: And momentum.

Columbia: Maybe following up on endpoints for your potential phase three program, your discussed body fat, lipids, and liver, how are some ways you could differentiate or measure those endpoints in a way that are more nuanced or detailed than other compounds. And then secondly, perhaps on potential partnerships, what are some attractive collaboration structures you're exploring? And at this point, do your match results at all factor into those partnership discussions? Thank you. Thanks, Columbia.

William Owen: In diabetes, maybe even.

William Owen: Where are you expecting to land in your in your phase two impact trial, and maybe what you've been seeing so far.

Scott Harris: Right, well, thank you, William. So.

William Owen: Alright, well thank you William.

Scott Harris: We believe that Pebba Jewtide, at the completion of studies, will prove itself to be the best tolerated incretin agent, either approved or in development. We believe this based on the pharmacokinetics of the compound with the slow entry of the drug into the bloodstream, and remember that any discontinuation rates we're seeing are essentially without any dose titration, which is really in stark contrast to other agents with tit Our longest titration period was four weeks.

William Owen: So.

Speaker Change: We believe that pivot do Todd.

Vipin Garg: At the completion of studies, it will prove to be the best tolerated incretin agent. But in addition, we are now allowing for dose reduction, which is something that has been employed in other trials and that we're going to employ going forward. And it also mimics the real-life use of these drugs.

Speaker Change: At the completion of studies will prove itself to be the best tolerated incur 10 agents.

Vipin Garg: Either approved or in development.

Vipin Garg: We believe that based on the pharmacokinetics of the compound with a slow entry of <unk> into the bloodstream and remember that any discontinuation rates, we're seeing are essentially without any dose titration.

Vipin Garg: I'll take the first question about the endpoints of the phase three trial and all as victim to answer the second question about the collaborations. So, you know, we think that the endpoints are fairly clear because they represent meaningful clinical changes. You know, for example, serum lipids are a clear surrogate for cardiovascular risk and there's been a very strong association of liver fat with not only cardiovascular outcomes, but outcomes in a variety of other organs such as the kidney.

Vipin Garg: Which is really in Stark contrast to other agents with tight trading now up to 32 weeks, our longest titration period was four weeks.

Scott Harris: And also, those adverse event discontinuation rates that were observed were observed without allowing for dose reduction, which was employed in as many as 30% of patients in the semiglutide intraceptive trials. So we have tremendous optionality in improving the tolerability of the compound going into phase three, and we'll have those discussions with the agency and get their feedback about the best approach. Previously, we had zero adverse event discontinuations in a diabetes trial.

Vipin Garg: And then also those adverse event discontinuation rates that were observed were observed without allowing for dose reduction which was employed in as many as 30% of patients.

Vipin Garg: <unk> appetite trials, so we have tremendous optionality and improving the tolerability of the compound going into phase III and we will have those discussions with the agency and get their feedback about the breast approach.

Vipin Garg: So, we believe that simply demonstrating improvement of those endpoints will be very meaningful. As we mentioned, we also have class leading preservation of lean mass among the Inquitant agents, either approved or in development. And we think that's extremely important as a standalone because the loss of lean masses been associated with loss of physical function, fractures, and also in some cases mortality. Many of these endpoints would take far larger trials to demonstrate, but we believe that they stand on their own as surrogates and are clinically meaningful.

Vipin Garg: Previously, we had zero adverse event discontinuation and her diabetes trial and as we announced on the call today and in the publication of journal of Herpetology. The adverse event discontinuation rate in subjects, who received <unk> in that trial was only two 9% and again with the odds.

Scott Harris: And as we announced on the call today and in the publication of the Journal of Hepatology, the adverse event discontinuation rate in subjects who received Pembijutad in that trial was only 2.9%. And again, with the odds stacked against the compound because of the relative absence of dose titration and also not allowing for dose reduction. Now, going forward, we have lots of options. One is to extend the titration period. We can get feedback from the agency on that proposal.

Speaker Change: Parked against the compound.

Speaker Change: So the relative absence of dose titration and also not allowing for dose reduction.

Vipin Garg: Going forward, we have lots of options one is to extend the titration period, we can get the feedback from the agency on that proposal.

Scott Harris: Although we believe that that 1.2 milligram dose, which produces 10% weight loss in clinical trials, doesn't need to be dose titrated and can be administered straight off without dose titration, achieving as much as 10% weight loss in that population. So for primary care, that's a very, very attractive dose to give. But we're also going to look for approval of the 1.8 and 2.4 milligrams. As we've discussed in other discussions with the community,

Vipin Garg: Although we believe that about $1, two milligram dose, which produces 10% weight loss and clinical trials doesn't need to be dose titrated and it can be administered straight off without dose titration, achieving as much as 10% weight loss in that population. So for primary care, that's a very very attractive.

Ray George: Yeah, so with regards to this structure, I can't really get into the specific details of the structures, but you know, we are open to multiple different structures. The focus is to get full value for the asset, as you know, family due to this, you know, basically pipeline in a product, we have got two major indications that we are pursuing, so we want to make sure we are able to capture the upside on both of those indications. So, you know, there are so many different ways to capture that value and structure the deals, so we're able to get full value for the asset. Thank you.

Operator: One moment for our next question.

Vipin Garg: <unk> to give but we're also going to look for approval of the one eight and two four milligrams.

Vipin Garg: As we've discussed in other other.

Vipin Garg: Other discussions.

Vipin Garg: With the community.

Scott Harris: But in addition, we are now allowing for dose reduction, which is something that has been employed in other trials and that we're going to employ going forward. And it also mimics the real-life use of these drugs. So consequently, we believe that we have a great adverse event discontinuation rate, shown mainly in the diabetes and the NAFLD population. And we have lots of tools in our tool chest for improving it further. We saw in the development of semaglutide and trizepatide, 25 to 30 percent adverse discontinuation rates in their Phase 2 trials, which became single desserts in Phase 3.

Vipin Garg: But in addition, we are now allowing for dose reduction, which was something that had been employed in other trials that we're going to employ going forward and it also mimics real life use of these drugs. So consequently, we believe that we have a great adverse event discontinuation rate shown mainly in the diabetes.

SEMA Shoran: Our next question comes to the line of SEMA Shoran from Everton.

SEMA Shoran: Hi, this is SEMA, I'm Felisa, thank you for reading my questions. I feel expecting space to nas data in first quarter, can you expand on like how the environment is going and when you expect it to be complete, and my second question is on oral envy, do you guys, you have mentioned that you plan to announce a candidate by year and is that still the case and what are some of the, you know, like characteristics of this candidate that you are looking for.

Speaker Change: And the natural depopulation, we have lots of tools of Nord pool Trust for improving it further we saw development of <unk> appetite, 25% to 30% adverse discontinuation rates in their phase III trials, which became single desserts in phase III, we believe that likewise by employing the tools.

Vipin Garg: Thank you. Thanks, email. I'll answer the first question.

Scott Harris: We believe that, likewise, by employing the tools that are commonly used between Phase 2 and Phase 3 to adjust the dose, we're going to have really nice adverse event discontinuation rates in our Phase 3 program when it's finally read out.

Vipin Garg: That are commonly used between phase II and phase III to adjust the dose we're going to have really nice adverse event discontinuation rates and our phase III program. When it's finally read out.

William Owen: Got it. Very helpful. I appreciate that. And then there's just one extra. You've got it.

Mayank Mamtani: got it very helpful, I appreciate that, and then just one extra, you've got a couple of presentations coming up at EASD, you know, specifically on the muscle data you've got; you'll be presenting data on the VATSAT and TAT. I'm just kind of curious what exactly we may be expecting, you know, all doses, maybe just give us a little color on where or what we should be expecting as far as the muscle data, and then also, could you just remind me, have you or do you have any plans to look into functional benefit given that you're showing the least amount of lean muscle mass loss in your patients? Thank you.

Scott Roberts: I'll ask Scott Roberts to address the oral candidates. So enrollment is going extremely well. We've been told that we're enrolling this trial faster than any other mass trial, and that represents the fact that the trial is attracted to patients because of the weight loss that it offers. So screening has not been a problem. We do intend to complete screening in the near future, and then we can provide you an update on, you know, the estimated date of the announcement of the trial results, which we still believe will be in the first quarter of 2025.

Speaker Change: Got it very helpful. I appreciate that and then just one extra <unk> got.

Speaker Change: A couple of presentations coming up at <unk>.

William Owen: <unk>.

Speaker Change: Specifically on the muscle data, you've got you'll be presenting data on that that sat in tat.

Speaker Change: I'm just kind of curious what exactly we may be expecting all doses.

Speaker Change: Maybe you can just give us a little color on where or what we should be expecting as far as the muscle data and then also if you could just remind me have you or do you have any plans to look into a functional benefit.

Speaker Change: Given that youre, showing the least amount of lean muscle loss lean muscle mass loss in your patients.

Scott Roberts: Scott, did you want to address the question about the oral formulation? Sure, good morning, and thank you for the question. You know, our efforts on the oral formulation are continuing. We've actually expanded the number of types of formulations that we're looking at prototype formulations. We're still hopeful that we can nominate one of these formulations for formal development by the end of the year. I think that on the oral formulations.

Scott Harris: Thank you. Yeah, thanks for the question, William. So the details on the muscle, the VAT, the side, and the top will all come out in the presentation that we plan to make at EASL. So, you know, stay tuned. There's some preliminary information out there, but we'll give a much more detailed presentation at that meeting in Madrid in September.

Speaker Change: Thank you, yes. Thanks for the thanks for the question <unk>. So the details on the muscle the vast the side on the Todd will all come out in the presentation that we plan to make it easily so stay tuned.

Speaker Change: There is some preliminary information out there, but we will be give a much more detailed presentation at that meeting in Madrid.

Scott Harris: But, you know, again, at this point in time, we're leading in lean mass preservation among the increase in agents. And we think that's extremely important. Functional benefit is extremely important. And that's a discussion that we're having with the agency right now on the design of a phase three trial. So stay tuned. We hope to announce on that in the near future.

Speaker Change: In September.

Speaker Change: But again at this point in time, we're leading in lean mass preservation, among the acreage and agents and we think that's extremely important functional benefit is extremely important and that's a discussion that we're having with the agency right now on the design of a phase III trial, so stay tuned and we hope to announce on that in the near future.

Scott Roberts: There's an important point that I do want to. And is that success with Henry Dutide, the peptide as no formulation is really that we're seeing with the small molecule oral formulations, which are obviously working. But the amount of weight loss and the overall potency, the adverse event profile of the Dutide is well established. And an oral formulation that delivers the peptide into the blood at equivalent concentrations to what we plan to do is the same profile.

William Owen: Yes.

William Owen: I appreciate it. Thank you. I'll hop back into the queue and congratulate you again.

Scott Harris: I appreciate it. Thank you. I'll hop back into the queue and congratulate you again.

William Owen: Yes.

Speaker Change: I appreciate it thank you I'll hop back into queue and congratulations again.

John Wolleben: Thank you. Our next question comes from the line of John Wolleben from Citizens JMP.

Operator: Thank you. Our next question comes from the line of John Wolleben from Citizens JMP.

Speaker Change: Thank you. Our next question comes from the line of Jon will have been from citizens JMP.

John Wolleben: Hey, good morning. Two questions from me, one piggybacking on the last. Do we have any, you know, data, literature, or thoughts on, you know, the body composition changes and, you know, how those translate to anything clinically and, you know, any thoughts on how the differences you're seeing, you know, if it's a 30% versus 40% fat loss, what could that mean? You know, do you think that's a meaningful enough difference to translate to some kind of clinical or functional change?

John Wolleben: Hey, good morning.

John Wolleben: Two questions for me one piggybacking on the last.

John Wolleben: Do we have any data literature or thoughts on that.

Scott Roberts: Fowl. So we're really very differentiated with respect to small molecules which are clearly active but not really pushing the levels of weight loss that that you see with with the socutaneous peptides and also have, you know, higher rates of adverse events, as you know, so we still think this project is extremely valuable. The goal is to achieve a pen big do type like clinical profile with the oral formulation. So, we'll update you as we know further advances there.

Operator: Thank you.

Speaker Change: <unk> composition changes.

Speaker Change: How those translate to.

Speaker Change: Anything clinically and any thoughts on how the differences youre seeing.

Speaker Change: It's at 30% versus 40%.

Speaker Change: Fat loss.

Speaker Change: Would that mean do you think thats a meaningful enough difference could translate to some kind of clinical or functional change.

Operator: One moment for our next question.

John Wolleben: Yeah, thanks, Jonathan. So there's limited data on the effects of changes in body composition on these functional measures that William just asked about. We know that in population studies that low lean body mass is associated with poor outcomes, um, Higher Morbidity and Mortality, and there's a wealth of data talking about that. Getting to not the actual amount of lean mass that you have, but the change.

John Wolleben: Yes, thanks, Jonathan.

John Wolleben: So.

Speaker Change: There is limited data on the effects of changes in body composition.

John Wolleben: to these functional measures that William just asked about. We know that in population studies that low lean body mass is associated with poor outcomes, higher morbidity and mortality, and there's a wealth of data talking about that. Looking not at the actual amount of lean mass that you have, but the change.

Speaker Change: Two these functional measures that William just asked about we know that in population studies that low lean body mass is associated with poor outcomes.

Omari Baruti: Our next question comes from the line of Corinne Johnson from Goldman Sachs. Good morning, this is Omari on from Corinne, so we have a couple questions.

John Wolleben: Higher morbidity and mortality and there is a wealth of data talking about that.

Vipin Garg: In the past, you are going to start this apprenticeship prior to CK regulatory approval, this that remain in aim and how would you think about executing identity next steps as for the right about the agency, absent a partner. And then second, what is your business as you approach the agency for online on the end of phase two meeting, if okay for future studies. I'm sorry, can you repeat your first question. Sure, so in the past, you had one of the partnership prior to CK regulatory approval that's that remain in aim, and how would you want to take about execute and get next steps provided by the agency with partner.

John Wolleben: Getting to not the actual amount of lean mass that you have but the change the best data that we have is from two studies.

Scott Harris: The best data that we have is from two studies. One is a look-ahead trial of weight loss, where lean mass loss was associated with bone fractures. And this was also seen in the semaglutide select trial, where they had a 40% loss of lean mass. And in that trial, a higher rate of pelvic and hip fractures that actually made it into the semaglutide label. So this is the data that we have. I think that we're going to be really developing and presenting a lot of new, important data that we hope will substantiate those benefits. But we do believe that preservation of lean mass is extremely important, and I think we also have to look at functional measures, as suggested by William.

John Wolleben: The best data that we have is from two studies where lean mass loss was associated with bone fractures. And this was also seen in the semaglutide select trial, where they had a 40% loss of lean mass and in that trial, a higher rate of pelvic and hip fractures that actually made it into the semaglutide label. So this is the data that we have.

John Wolleben: One is the look ahead trial of.

John Wolleben: Of weight loss.

Speaker Change: Our lean mass loss was associated with bone fractures and this was also seen in the <unk> select trial, where they had a 40% loss of lean mass and in that trial, a higher rate of pelvic and hip fractures that actually made it into the <unk> Todd.

John Wolleben: Later label.

John Wolleben: I think that we're really going to be developing and presenting a lot of new important data that we hope will substantiate those benefits. But we do believe that preservation of lean mass is extremely important. And I think we also have to look at the functional measures, as was asked by William.

John Wolleben: So this is the data that we have I think that we're going to be really developing and presenting a lot of new.

Vipin Garg: Oh, okay, I got it. So sorry, so in terms of partnership prior to approval, I mean, look, our goal has always been to have a partner lined up before we start the phase three development in obesity. In mash, it's a different story. We think we can take it forward on our own in mash. And part of the reason we are looking at these additional indications that gives us additional flexibility, even even an obesity related indication. So we'll see what feedback we get from the FDA at the end of phase two meeting as well as we have other interactions planned with the FDA to discuss the additional indications that we are evaluating.

John Wolleben: Important data that we hope will substantiate those benefits, but we do believe that preservation of lean mass. This extremely important and I think we also have to look at the functional measures as was asked by William and Thats, a discussion that we'll have with the agency and near.

John Wolleben: And that's a discussion that we'll have with the agency in the near future. In terms of meaningful differences, we know that visceral fat and liver fat are associated with cardiovascular risk. And we're seeing very prominent reductions of both here with Penfidu Tide. So that, combined with the reduction of serum lipids, not only the typical lipoproteins but all the cardioinflammatory lipids that we presented at the easel and the ADA meeting, is going to result in an improved cardiovascular profile.

Scott Harris: And that's a discussion that we'll have with the agency in the near future. In terms of meaningful differences, we know that visceral fat and liver fat are associated with cardiovascular risk, and we're seeing very prominent reductions of both here with pendidutide. So that, combined with the reduction of serum lipids, not only the typical lipoproteins but all the cardioinflammatory lipids that we presented at the ESL and the ADA meeting, is going to result in an improved cardiovascular profile.

John Wolleben: Future.

John Wolleben: And in terms of the meaningful differences, we know that visceral fat in liver fat or associated with cardiovascular risk and we're seeing very prominent reductions are both here with <unk>.

Scott Harris: And once we have that information, we'll be able to make a better decision as to how to move forward. I'm Ray. This is Scott. I'm going to ask you to repeat the second question because I didn't hear it. The audio quality wasn't good enough. Could you please repeat the question. Sure.

John Wolleben: So that combined with the loss the reduction of serum lipids not only the typical lipoproteins, but all of the car to inflammatory lipids that we presented at the easel and the Ada meeting this is <unk>.

John Wolleben: Going to result in an improved cardiovascular profile, we know that in the recent select trial. There was a 20% reduction in mace events associated with weight loss alone, but as I mentioned.

John Wolleben: We know that in the recent select trial, there was a 20% reduction in MACE events associated with weight loss alone. But, as I mentioned, the reduction of serum lipids with that agent is minimal. With semaglutide, generally around a 3% reduction in total cholesterol or LDL cholesterol, maybe as high as 5% in some studies. That compares to the approximate 20% effect that we're getting with pemvidutide. So on top of the benefit that was seen with semaglutide in the select trial, we think we can do even better when a cardiovascular outcomes trial is conducted.

Scott Harris: We know that in the recent SELECT trial, there was a 20% reduction in MACE events associated with weight loss alone. But, as I mentioned, the reduction of serum lipids with that agent is minimal. With semaglutide, generally around a 3% reduction in total cholesterol or LDL cholesterol, maybe as high as 5% in some studies. That compares to the approximate 20% effect that we're getting with pemvidutide. So on top of the benefit that was seen with semaglutide in the SELECT trial, we think we can do even better when a cardiovascular outcomes trial is conducted.

Scott Harris: What is your wish list as you approach the agency for alignment on an end of phase two meeting and prepare for future studies? Well, I think this was partially addressed previously. So we believe that we have a highly differentiated compound. We believe that the obesity marketplace is going to segment with different patient needs. We stress repeatedly that 70% of the marketplace is dislipidemic or high liver fat. So consequently, rather than saying, you know, this is a program for the treatment of obesity.

John Wolleben: The reduction of serum lipids.

John Wolleben: With that agent is minimal and with some of <unk> generally around 3% reduction in total cholesterol LDL cholesterol, maybe as high as 5% of the studies that compares to the approximately 20% effects that we're getting with <unk>. So on top of the benefit that was seen with <unk>.

John Wolleben: We think we can do even better when a cardiovascular outcomes trial is conducted.

John Wolleben: That makes sense, and my second question is, if a partnership doesn't take shape, how are you thinking strategically about potentially moving PEMDU forward yourself? It seems like an obesity phase 3 program might be, you know, too large, but you mentioned three additional indications that could make sense. Can you talk a little bit about, if a partnership doesn't take place, the potential path forward for PEMDU?

Speaker Change: That makes sense and my second question is.

Speaker Change: If a partnership doesn't take shape.

Speaker Change: How are you thinking strategically about potentially moving can be forward yourself. It seems like an obesity phase III program might be.

Scott Harris: We're going to highlight that this is a program for the treatment of subjects with obesity with high serum lipids, high liver fat, and also people who might be subjects to the effects of excessive lean muscle loss. So the differentiates our end of phase two discussion from others that may have preceded it is that we're not going in and saying this is an approval for obesity. We're saying this is an approval for obesity focusing on the key attributes of Pemphidutide that create our target product profile, which we will use to commercialize the compound. And we think that differentiation will not only be attractive in the marketplace, but for potential partners as well.

Speaker Change: Two large but you mentioned three additional indications that could make sense can you talk a little bit about if a partnership doesn't take place the potential path forward for <unk>.

Vipin Garg: Yeah, first of all, let me say, Jonathan, that we continue to be optimistic that we will have a partner lined up, particularly after we have the outcome of the end of phase two meeting. We are looking at some very interesting trial designs that we think will be very attractive to a partner. The name of the game here... is to try to differentiate the idea of being fourth or fifth in a cretin-based agent for obesity.

Jonathan Wolleben: Yeah, first of all, let me say, Jonathan, that we continue to be optimistic that we will have a partner lined up, particularly after we have the outcome of the end of phase two meeting. We have the outcome of the end of phase two meeting because we're looking at some very interesting trial designs that we think will be very attractive to a partner. The name of the game here...

John Wolleben: Yes first of all let me say John.

Jonathan Wolleben: Jonathan that we continue to be optimistic that we will have a partner lined up particularly after we have at the end of phase II meeting.

Operator: Thank you.

Jonathan Wolleben: We have the outcome from the end of phase II meeting because we're looking at some very interesting.

Operator: One moment for our next question.

Jonathan Wolleben: Trial designs that we think will be very attractive to the partner the name of the game here.

Jonathan Wolleben: Is to try to differentiate.

Speaker Change: The idea of being four to five integrate.

Speaker Change: <unk> based agent for obesity, how are you.

Vipin Garg: How are you gonna differentiate yourself? So I think that's what we are focused on in our partnership discussions. It's encouraging to see that our partners are also focused on that, and they're getting the message there. We're hearing it from a number of potential players that they're looking for a differentiated asset in the obesity space. So that's exactly what we are working on. So stay tuned.

Jonathan Wolleben: Going to differentiate yourselves. So I think thats, what we are focused on in our partnership discussions it's encouraging to see that our partners are also focused on that and they are getting the message.

Jonathan Wolleben: Hitting it from a number of potential players that they are looking for a differentiated asset in the obesity space.

William Owen: Our next question comes to the line of Mayank Mamtani from Be Riley Securities. Hi, thanks so much. This is actually William Owen from Mayank. Congratulations on the nice quarter. Just a couple questions from us. The first is I'm just kind of curious about the discontinuation rate variants that you've seen from prior phase two trials, whether it be in momentum and diabetes, maybe even in your naffled earlier trial. So where are you expecting to land it in your in your phase two impact trial and maybe what you've been seeing so far.

Jonathan Wolleben: So thats exactly what we are working on so stay tuned with a bullish about our.

John Wolleben: We're very bullish about our plans for a unique phase three trial designed for family dutide for obesity. In addition, as we have mentioned multiple times, we're looking at additional indications that we can execute on our own. So we're approaching it from multiple angles. But first and foremost, we believe that we have a very differentiated asset, and it'll be attractive to a partner.

Speaker Change: Plans for.

Jonathan Wolleben: A unique phase III trials are designed for family do tight for obesity. In addition, as we've mentioned multiple times. We are looking at additional indications that we can execute on our own. So that we are approaching it from multiple angles, but first and foremost we think we believe that.

Jonathan Wolleben: We have a very differentiated asset and it will be attractive to a partner.

John Wolleben: Got it. Thanks again for taking the question.

Speaker Change: Got it thanks again for taking the questions.

Operator: Thank you. At this time, I would now like to turn the conference back over to Vipin Garg for closing remarks.

Vipin Garg: Thank you. At this time, I would now like to turn the conference back over to Vipin Garg for closing remarks.

Jonathan Wolleben: Thank you at this time I would now like to turn the conference back over to Vipin Garg for closing remarks.

William Owen: Right. Well, thank you William. So we believe that Pemphidutide at the completion of studies will prove itself to be the best tolerated in curtain agent either approved during development. We believe that based on the pharmacokinetics of the compound with the slow entry of dread into the bloodstream. And remember that any discontinuation rates we're seeing are essentially without any dose titration, which is really in stark contrast to other agents with titrating now up to 32 weeks, our longest iteration period was four weeks.

Vipin Garg: Yeah, thank you everyone for joining our call today. As always, we greatly appreciate this opportunity to share our meaningful developments and results with you and would like to thank you for your ongoing support. Have a wonderful rest of your day.

Vipin Garg: Yeah, thank you everyone for joining our call today. As always, we greatly appreciate this opportunity to share our meaningful developments and results with you and would like to thank you for your ongoing support. Have a wonderful rest of your day.

Vipin Garg: Yes. Thank you everyone for joining our call today as always we greatly appreciate this opportunity to share our meaningful developments and results with you.

Operator: This concludes today's conference call. Thank you for participating. You may now disconnect.

Vipin Garg: And would like to thank you for your ongoing support have a wonderful rest of your day.

Speaker Change: This concludes today's conference call. Thank you for participating you may now disconnect.

Vipin Garg: Okay.

William Owen: And also those adverse event discontinuation rates that were observed, observed without allowing for dose reduction, which was employed in as many as 30% of patients in the semiglutide and terseptide trials. So we have tremendous optionality in improving the tolerability of the compound going into phase three. And we'll have those discussions with the agency and get their feedback about the breast approach. Previously, we had zero adverse event discontinuations under diabetes trial. And as we announced on the call today and in the publication of journal of hepatology, the adverse event discontinuation rate in subjects who received Pemphidutide in that trial was only 2.9%.

William Owen: And again, with the odds stacked against the compound because of the relative absence of dose titration and also not allowing for dose reduction. Now, going forward, we have lots of options. One is to extend the titration period. We can get the feedback from the agency on that proposal. Although we believe that that 1.2 milligram dose, which produces 10% weight loss in clinical trials, doesn't need to be dose tritrated and can be administered straight off without dose titration, achieving as much as 10% weight loss in that population.

William Owen: So for primary care, that's a very, very attractive dose to give. But we're also going to look for approval of the 1.8 and 2.4 milligrams as we've discussed in other other discussions with the community. But in addition, we are now allowing for dose reduction, which is something that had been employed in other trials and that we're going to employ going forward. And it also mimics real-life use of these drugs. So consequently, we believe that we have a great adverse event discontinuation rate shown mainly in the diabetes in the Nathalie population.

William Owen: We have lots of tools in our tool trust for improving it further. We saw on development of semaglutide and chisepatide, 25 to 30% adverse discontinuation rates in their phase two trials, which became single desserts in phase three. We believe that likewise by employing the tools that are commonly used between phase two and phase three to adjust the dose, we're going to have really nice adverse event discontinuation rates in our phase three program when it's finally read out.

William Owen: Got it. Very helpful. I appreciate that. And then just one extra. You've got a couple of presentations coming up at ESD. Specifically on the muscle data, you'll be presenting data on the VATSAT and TAT. I'm just curious, what exactly we may be expecting, all doses. Maybe just give us a little color on where or what we should be expecting as far as the muscle data. And then also, if you could just remind me, have you or do you have any plans to look into functional benefit given that you're showing the least amount of lean muscle mass loss in your patients.

William Owen: Thank you. Thanks for the question, William. So the details on the muscle, the VAT and the TAT will all come out in the presentation that we plan to make it easel. So, you know, state should do some preliminary information out there, but we'll be give a much more detailed presentation at that meeting in Madrid in September. But, you know, again, at this point in time, we're leading in lean mass preservation among the encouraging agents.

William Owen: And we think that's extremely important. Functional benefit is extremely important. And that's the discussion that we're having with the agency right now on the design of a Phase III trial. So stay tuned. We hope to announce on that in the near future. Appreciate it. Thank you.

William Owen: I'll hop back into you.

Jonathan Wolleben: Thank you.

Jonathan Wolleben: Our next question comes to the line of John Wooliban from Citizens JMP. Good morning. Two questions from me. One, piggybacking on the last. Do we have any, you know, data, literature, thoughts on, you know, the body composition changes and, you know, how those translate to anything clinically? And, you know, any thoughts on how the difference is you're seeing, if it's a 30% versus 40% fat loss, you know, what could that mean?

Jonathan Wolleben: Do you think that's a meaningful enough difference to translate to some kind of clinical or functional change? Yeah, thanks, Jonathan. So there's limited data on the effects of changes in body composition to these functional measures that William just asked about. We know that in population studies that low lean body mass is associated with poor out. Comps, Higher Morpidity and Mortality, and there's a wealth of data talking about that. Getting to not the actual amount of lean mass that you have, but the change, the best data that we have is from two studies.

Jonathan Wolleben: One is the look ahead trial of weight loss where lean mass loss was associated with bone fractures, and this was also seen in the semi-glutide select trial, where they had a 40% loss of lean mass and in that trial a higher rate of pelvic and hip fractures that actually made it into the semi-glutide label. So this is the data that we have. I think that we're going to be really developing and presenting a lot of new important data that we hope will substantiate those benefits, but we do believe that preservation of lean mass is extremely important.

Jonathan Wolleben: And I think we also have to look at the functional measures as was asked by William, and that's a discussion that we'll have with the agency in near future. And in terms of the meaningful differences, we know that visceral fat and liver fat are associated with cardiovascular risk, and we're seeing very prominent reductions of both here with Pempedudutide. So that combined with the loss of the reduction of serum lipids, not only the typical lipoproteins, but all the cardiovascular lipids that we presented at the EASL and the ADA meaning, is going to result in an improved cardiovascular profile.

Jonathan Wolleben: We know that in the recent select trial, there was a 20% reduction in NACE events associated with weight loss alone, but as I mentioned, the reduction of serum lipids with that agent is minimal. With semi-glutide, generally around 3% reduction in total cholesterol, or LDL cholesterol, maybe as high as 5% of them studies, that compares to the approximate 20% effects that we're getting with Pempedudutide. So in top of the benefit that we're seeing, with semi-glutide and the select trial, we think we can do even better when a cardiovascular outcomes trial is conducted. That makes sense.

Vipin Garg: And my second question is, if a partnership doesn't take shape, how are you thinking strategically about potentially moving forward yourself? It seems like an obesity-based program might be too large, but you mentioned three additional indications that could make sense. Can you talk a little bit about if a partnership doesn't take place, the potential path for Pempedudutide? Yeah, first of all, let me say, Jonathan, that we continue to be optimistic that we will have a partner lined up, particularly after we have the end of phase two meeting, we have the outcome from the end of phase two meeting, because we're looking at some very interesting trial designs that we think will be very attractive to a partner.

Vipin Garg: The name of the game here is to try to differentiate the idea of being for the fifth integrated, incredible-based agent for obesity, how are you going to differentiate yourself? So I think that's what we're focused on in our partnership discussions. It's encouraging to see that our partners are also focused on that, and they're getting the message they're, we're hearing it from a number of potential players that they're looking for a differentiated asset in the obesity space.

Vipin Garg: Harris. So that's exactly what we are working on. So, stay tuned, we'll very bullish about our plans for a unique phase three trial, design for, for, when we do type for obesity. In addition, as we've mentioned multiple times, we're looking at additional indications that we can execute on our own. So, that we're, you know, approaching it from, from multiple angles, but first and foremost, we think we believe that we have a very differentiated asset and it'll be attractive to a partner.

Jonathan Wolleben: Actually, I have a third of the questions. Thank you.

Vipin Garg: At this time, I would now like to turn the conference back over to Vipin Garg for closing remarks. Yeah, thank you everyone for joining us all today. As always, we greatly appreciate this opportunity to share our meaningful developments and results with you and would like to thank you for your ongoing support.

Operator: Have a wonderful rest of your day.

Operator: This concludes today's conference call. Thank you for participating.

Operator: You may now disconnect.