Q2 2026 Altimmune Inc Earnings Call

August 12, 2026

Operator: Good morning, ladies and gentlemen. Welcome to the Altimmune Second Quarter 2026 Financial Results Conference Call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising that your hand is raised. As a reminder, this call is being recorded. I will now introduce your host for today's conference call, Luis Sanay, Vice President of Investor Relations. Luis, you may begin.

Speaker #2: Good morning, Lisa and gentlemen. Welcome to the Altimmune second quarter 2026 financial results conference call. At this time, all participants on the listen-only mode.

Speaker #2: After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star one one on your telephone.

Speaker #2: You will then hear an automated message advising that your hand is raised. As a reminder, this call is being recorded. I'm going to introduce your host for today's conference call, Louise Senic, Vice President of Investor Relations.

Speaker #2: Louise, you may begin.

Speaker #3: Thank you, operator, and good morning, everyone. Thank you for joining us for Altimmune's second quarter 2026 financial results and business update call. On today's call, you will hear from Jerry Dersow, our Chairman and Chief Executive Officer.

Luis Sanay: Thank you, operator, and good morning, everyone. Thank you for joining us for Altimmune's Second Quarter 2026 Financial Results and Business Update Call. On today's call, you will hear from Jerry Durso, our Chairman and Chief Executive Officer, Dr. Christophe Arbet-Engels, Chief Medical Officer, Linda Richardson, Chief Commercial Officer, and Greg Weaver, Chief Financial Officer. Following management's prepared remarks, we will open the line for questions. Our second quarter 2026 earnings release was issued this morning and can be found in the Investor Relations section of our website. Before we begin, I would like to remind everyone that remarks made about future expectations, plans and prospects constitute forward-looking statements for the purpose of safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Altimmune cautions that these forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those indicated.

Speaker #3: Dr. Christoph Arvid Angles, Chief Medical Officer. Linda Richardson, Chief Commercial Officer. And Greg Weaver, Chief Financial Officer. Following management's prepared remarks, we'll open the line for questions.

Speaker #3: Our second quarter 2026 earnings release was issued this morning and can be found on the Investor Relations section of our website. Before we begin, I would like to remind everyone that remarks made about future expectations, plans, and prospects constitute forward-looking statements for the purpose of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995.

Speaker #3: Altimmune cautions that these forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those indicated. For a review of the risk factors that could affect the company's future results and operations, we refer you to our SEC filings.

Luis Sanay: For a review of the risk factors that could affect the company's future results and operations, we refer you to our SEC filings. I also direct you to read the forward-looking statements disclaimer in our press release issued this morning. Any statements made on this call speak only as of today's date, 12 August 2026, and the company does not undertake any obligation to update any of these forward-looking statements to reflect events or circumstances that occur on or after today's date. As a reminder, this call is being recorded and will be available for audio replay on our website. With that, I will now turn the call over to Jerry.

Speaker #3: I also direct you to read the forward-looking statements disclaimer in our press release issued this morning. Any statements made on this call speak only as of today's date, August 12, 2026, and the company does not undertake any obligation to update any of these forward-looking statements to reflect events or circumstances that occur on or after today's date.

Speaker #3: As a reminder, this call is being recorded and will be available for audio replay on our website. With that, I'll now turn the call over to Jerry.

Speaker #4: Good morning, everyone.

Jerome Durso: Good morning, everyone. Thank you for joining us today for our second quarter 2026 financial results and business update call. 2026 is proving to be a year of significant progress as Altimmune evolves into a late-stage company dedicated to serious liver diseases. We have been laser-focused on execution since the beginning of the year and believe we are well positioned to advance our strategy and deliver on our mission. Pemvidutide is our foundation, and our confidence and conviction in its potential continues to strengthen with the growing body of clinical evidence. We are building momentum across our pemvidutide franchise and are excited for the future. Let me take a minute to highlight our recent progress. Starting with MASH. Last week, we announced the initiation of the PERFORMA Phase III trial as we began enrolling patients in the global program.

Speaker #3: Thank you for joining us today for our second quarter 2026 financial results and business update call. 2026 is proving to be a year of significant progress, as Altimmune evolves into a late-stage company dedicated to serious liver diseases.

Speaker #3: We've been laser-focused on execution since the beginning of the year, and believe we're well positioned to advance our strategy and deliver on our mission.

Speaker #3: HEMA due tide is our foundation, and our confidence and conviction in its potential continues to strengthen with the growing body of clinical evidence. We're building momentum across our PEMA due tide franchise, and are excited for the future.

Speaker #3: Let me take a minute to highlight our recent progress. Starting with MASH, last week we announced the initiation of the Performa Phase 3 trial as we began enrolling patients in the global program.

Speaker #3: We worked with urgency to get the trial started quickly, just three months after securing the financial resources to fund the study through the 52-week readout.

Jerome Durso: We worked with urgency to get the trial started quickly, just 3 months after securing the financial resources to fund the study through the 52-week readout. We are very encouraged by the start of the trial. Sites are being activated quickly, and we are seeing great engagement by the medical community about what PERFORMA may mean for the MASH treatment landscape. There remains a significant unmet need in MASH. We believe pemvidutide, with its balanced one-to-one glucagon and GLP agonism in a single molecule, has the potential to offer a differentiated profile for MASH patients. Moving now to alcohol use disorder, or AUD. We were pleased to report positive top-line data from the RECLAIM phase II trial last month.

Speaker #3: We're very encouraged by the start of the trial. Sites are being activated quickly, and we're seeing great engagement by the medical community about what Performa may mean for the MASH treatment landscape.

Speaker #3: There remains a significant unmet need in MASH; we believe PEMDI, with its balanced one-to-one glucagon and GLP agonism in a single molecule, has the potential to offer a differentiated profile for MASH patients.

Speaker #3: Moving now to alcohol use disorder, or AUD. We were pleased to report positive top-line data from the Reclaim Phase 2 trial last month. PEMA due tide delivered a very strong statistically significant and clinically meaningful reduction in heavy drinking days, which was the trial's primary endpoint.

Jerome Durso: Pemvidutide delivered a very strong, statistically significant, and clinically meaningful reduction in heavy drinking days, which was the trial's primary endpoint. The study also met important secondary endpoints, including a 2-level reduction in WHO risk drinking levels and zero heavy drinking days. It is important to note that either of these 2 measures are currently accepted as FDA registrational endpoints. The totality of the top-line data from RECLAIM strengthens our conviction in pemvidutide's potential in AUD. We are moving quickly to gather the full data from the trial, then prepare the data package to request an end of phase II meeting with the FDA to discuss next steps. These compelling data, which to our knowledge are the most robust presented in AUD, further strengthens the potential of pemvidutide as a differentiated therapy across serious liver diseases.

Speaker #3: The study also met important secondary endpoints, including a two-level reduction in WHO risk drinking levels, and zero heavy drinking days. It's important to note that either of these two measures are currently accepted as FDA registrational endpoints.

Speaker #3: The totality of the top-line data from Reclaim strengthens our conviction in PEMDI's potential in AUD. We're moving quickly to gather the full data from the trial, then prepare the data package to request an end-of-phase 2 meeting with the FDA to discuss next steps.

Speaker #3: These compelling data which, to our knowledge, are the most robust presented in AUD further strengthens the potential of PEMA due tide as a differentiated therapy across serious liver diseases.

Speaker #3: The results from the trial are also meaningful for the AUD patient community, where pemafibrate could represent an important advancement in an area that has lacked innovation for the past two decades.

Jerome Durso: The results from the trial are also meaningful for the AUD patient community, where pemvidutide could represent an important advancement in an area that has lacked innovation for the past 2 decades, and again, where a significant unmet need remains. There are approximately 12 million adults in the US with moderate to severe AUD. It is well accepted that this AUD population is more likely to develop liver disease. We believe pemvidutide is uniquely positioned to benefit these higher risk patients as its dual mechanism can address the totality of disease by reducing alcohol cravings while also providing a direct effect on the liver. This population could serve as a key commercial opportunity with substantial future sales potential. Pemvidutide has the potential to help address the continuum of liver diseases we are targeting, MASH, AUD, and ALD.

Speaker #3: And again, where a significant unmet need remains. There are approximately 12 million adults in the US with moderate to severe AUD. It's well accepted that this AUD population is more likely to develop liver disease.

Speaker #3: We believe PEMA due tide is uniquely positioned to benefit these higher-risk patients, as its dual mechanism can address the totality of disease by reducing alcohol cravings while also providing a direct effect on the liver.

Speaker #3: This population could serve as a key commercial opportunity with substantial future sales potential. PEMA due tide has the potential to help address the continuum of liver diseases we're targeting, MASH, AUD, and ALD.

Speaker #3: We've now delivered strong Phase 2 data in yet another indication, and we're well on our way towards building our PEMA due tide liver franchise.

Jerome Durso: We have now delivered strong phase II data in yet another indication, and we are well on our way towards building our pemvidutide liver franchise. We are committed to executing our strategy with speed and efficiency, and the significant progress we have made this year reflects that commitment. We remain laser-focused on executing on our goal of bringing pemvidutide to patients who may benefit from its promising and differentiated therapeutic profile, and creating value for our shareholders. With that, I will turn the call over to Christophe for a clinical update.

Speaker #3: We're committed to executing our strategy with speed and efficiency, and the significant progress we've made this year reflects that commitment. We remain laser-focused on executing on our goal of bringing PEMA due tide to patients who may benefit from its promising and differentiated therapeutic profile, and creating value for our shareholders.

Speaker #3: With that, I'll turn the call over to Christoph for a clinical update.

Speaker #4: Thank you, Jerry. I am very excited to share that we continue to advance our clinical programs across MASH, AUD, and ALD. Beginning with our program in MASH, last week we announced the initiation of the global PERFORM Phase 3 trial of pemvidutide in MASH and began enrolling patients.

Christophe Arbet-Engels: Thank you, Jerry. I am very excited to share that we continue to advance our clinical programs across MASH, AUD, and ALD. Beginning with our program in MASH. Last week, we announced the initiation of the global PERFORMA phase III trial of pemvidutide in MASH and began enrolling patients. Over the last few months, we moved very rapidly to set up a strong and experienced global infrastructure to initiate the trial. The trial will be conducted across approximately 300 sites with one-third in the US and two-thirds ex-US. We are working closely with our CRO on site activation in multiple countries and ensuring a smooth start to the trial for an efficient enrollment. The initiation of PERFORMA is an important milestone for Altimmune and for the advancement of MASH treatment. We also see a growing interest and excitement for pemvidutide in MASH from the scientific community.

Speaker #4: Over the last few months, we've moved very rapidly to set up a strong and experienced global infrastructure to initiate the trial. The trial will be conducted across approximately 300 sites with one-third in the US and two-thirds ex-US.

Speaker #4: We're working closely with our CRO on site activation in multiple countries and ensuring a smooth start to the trial for an efficient enrollment. The initiation of Performa is an important milestone for Altimmune and for the advancement of MASH treatment.

Speaker #4: We also see a growing interest and excitement for PEMA due tide in MASH from the scientific community. Our increased presence and engagement with the scientific community at the Easel and Soler Medical Conferences this year is driving awareness and has helped build momentum as we begin enrolling patients.

Christophe Arbet-Engels: Our increased presence and engagements with the scientific community at the EASL and AASLD medical conferences this year is driving awareness and has helped build momentum as we begin enrolling patients. Based on the strong phase II data we reported last year and the design of the PERFORMA trial, we are looking forward to studying pemvidutide in a registrational setting. Moving to AUD. In July, we were very happy to report the strongly positive top-line data from the RECLAIM phase II trial in AUD. The data readout was based on the ITT analysis as it would be for a pivotal study. The trial met its primary endpoint where pemvidutide 2.4 milligrams showed a highly statistically significant reduction in the average number of heavy drinking days versus placebo at week 24, with a treatment difference of 1.45 heavy drinking days per week.

Speaker #4: Based on the strong Phase 2 data we reported last year, and the design of the Performa trial, we are looking forward to studying PEMA due tide in a registrational ational setting.

Speaker #4: Moving to AUD. In July, we were very happy to report the strongly positive top-line data from the Reclaim Phase 2 trial in AUD. The data readout was based on the 90T analysis, as it would be for a pivotal study.

Speaker #4: The trial met its primary endpoints, where milligram showed a highly statistically significant reduction in the average number of heavy drinking days versus placebo at week 24, with a treatment difference of 1.45 heavy drinking days per week.

Christophe Arbet-Engels: Pemvidutide also met two critical secondary endpoints, both of which are registrational endpoints recognized by the FDA. On the first endpoint, we saw a highly statistically significant response in the 2-level reduction in WHO RDL versus placebo. Roughly two-thirds of pemvidutide patients achieved a 2-level reduction in WHO RDL versus only one-third on placebo. On the other FDA registrational endpoint of zero heavy drinking days, one that has historically been challenging to achieve, pemvidutide again showed a highly statistically significant improvement in percentage of patients with zero heavy drinking days. In this data, more than twice the number of the pemvidutide patients achieved zero heavy drinking days versus placebo patients. The trial also saw a highly statistically significant change in the percentage of days with drinking abstinence and PEth levels, which is an objective blood-based measure of recent alcohol intake over the last two to four weeks.

Speaker #4: PEMA due tide also met two critical secondary endpoints. Both of which are registrational endpoints recognized by the FDA. On the first endpoint, we saw a highly statistically significant response in a two-level reduction in WHO RDL versus placebo.

Speaker #4: two-thirds of PEMD patients achieved a two-level reduction in WHO RDL versus only one-third on placebo. On the other FDA registrational endpoint of zero heavy drinking days, one that has historically been challenging to achieve, PEMA due tide again showed a highly statistically Roughly significant improvement in percentage of patients with zero heavy drinking days.

Speaker #4: In these data, more than twice the number of the PEMD patients achieved zero heavy drinking days versus placebo patients. The trial also saw a highly statistically significant change in the percentage of days with drinking abstinence, and test levels which is an objective blood-based measure of recent alcohol intake over the last 2 to 4 weeks.

Christophe Arbet-Engels: Pemvi also showed a meaningful and statistically significant reduction in body weight from baseline with a 9.1% reduction with pemvidutide versus placebo. The totality of the data, including patients' reported measures such as the decrease in heavy drinking days, WHO RDL reduction, and the increase in zero heavy drinking days, as well as the PEth objective measure of alcohol intake, shows strong and consistent evidence in pemvidutide's potential to address the excessive alcohol usage in AUD patients. Considering the landscape of clinical studies in AUD, including looking at other available GLP-1 AUD trials, the totality of the RECLAIM data is, to our knowledge, the most robust to date. While RECLAIM was focused on drinking behavior, we evaluated in an exploratory manner whether patients with elevated FIB-4 above the threshold of 1.3 at baseline were seeing any improvement.

Speaker #4: PEMD also showed a meaningful and statistically significant reduction in body weight from baseline with a 9.1% reduction with PEMA due tide versus placebo. The totality of the data including patients reported measures such as the decrease in heavy drinking days, WHO RDL reduction, and the increase in zero heavy drinking days as well as the test objective measure of alcohol intake, shows strong and consistent evidence in PEMA due tide's potential to address the excessive alcohol usage in AUD patients.

Speaker #4: Considering the landscape of clinical studies in AUD, including looking at other available GLP-1 AUD trials, the totality of the Reclaim data is to our knowledge the most robust to date.

Speaker #4: While Reclaim was focused on drinking behavior, we evaluated in an exploratory manner whether patients with elevated FIT4 above the threshold of 1.3 at baseline were seeing any improvement.

Christophe Arbet-Engels: FIB-4 is an established biomarker correlated with risk for developing liver fibrosis. Given pemvidutide's direct glucagon effect on the liver, the observed data with 50% of pemvidutide patients with a FIB-4 index above 1.3 at baseline, achieving less than 1.3 after only 24 weeks, versus only 17% in placebo, is very encouraging, especially at such an early time point. We expect to further evaluate the potential liver benefit in the phase III study in AUD. In terms of safety and tolerability, pemvidutide continued to demonstrate a generally consistent safety and tolerability profile. Let me share a few thoughts as we look ahead to a potential phase III study in AUD, which of course, will be subject to our dialogue with US and European regulators. We would plan a phase III study in the moderate to severe AUD population.

Speaker #4: FIT4 is an established biomarker correlated with risk for developing liver fibrosis. Given PEMD's direct glucagon effect on the liver, the observed data with 50% of PEMA due tide patients with a FIT4 index above 1.3 at baseline achieving less than 1.3 after only 24 weeks versus only 17% in placebo is very encouraging, especially at such an early time point.

Speaker #4: We expect to further evaluate the potential liver benefit in the Phase 3 study in AUD. In terms of safety and tolerability, PEMA due tide continued to demonstrate a generally consistent safety and tolerability profile.

Speaker #4: Let me share a few thoughts as we look ahead to a potential Phase 3 study in AUD. Which, of course, will be subject to our dialogue with US and European regulators.

Speaker #4: We would plan a Phase 3 study in the moderate to severe AUD population. It is important to note that approximately 50% of AUD patients also have ALD.

Christophe Arbet-Engels: It is important to note that approximately 50% of AUD patients also have ALD. Therefore, we would expect to study a portion of ALD patients in the AUD phase III trial. We would look to broaden the study population to also include patients with a BMI under 25 and could explore a lower dosage option. We look forward to engaging with the FDA at an end of phase II meeting and discussing a path forward for AUD. In addition, we also plan to engage with European agencies such as EMA. In ALD, we are pleased to report that we completed patient enrollment in the RESTORE trial and expect top-line data in the second half of 2027. The trial enrolled approximately 120 patients with ALD and a history of chronic and heavy drinking at baseline.

Speaker #4: Therefore, we would expect to study a portion of ALD patients in the AUD Phase 3 trial. We would look to broaden the study population to also include patients with a BMI under 25 and could explore a lower dosage option.

Speaker #4: We look forward to engaging with the FDA at an End of Phase 2 meeting and discussing a path forward for AUD. In addition, we also plan to engage with European agencies such as the EMA.

Speaker #4: In ALD, we are pleased to report that we completed patient enrollment in the Restore trial and expect top-line data in the second half of 2027.

Speaker #4: The trial enrolled approximately 120 patients with ALD and a history of chronic and heavy drinking at baseline. To support future regulatory discussions, we have amended the trial protocol to be able to fully demonstrate the liver benefits in the ALD population that pemvidutide may provide at one year.

Christophe Arbet-Engels: To support future regulatory discussion, we have amended the trial protocol to be able to fully demonstrate the liver benefits in the ALD population that pemvidutide may provide at one year. The primary endpoint of the trial, the change from baseline in liver stiffness measurements or LSM, will now be assessed in a hierarchical manner at week 48 and then at week 24, allowing for both time points to be assessed. The RESTORE trial is now designed to show a liver benefit over a long period of time, and this is consistent with our development strategy of focusing on higher risk patients. Demonstrating a liver benefit over a long period of time could be a key differentiator for pemvidutide versus other AUD therapies in development because AUD patients are often already presenting some level of liver impairment.

Speaker #4: The primary endpoint of the trial: the change from baseline in liver stiffness measurements or LSM will now be assessed in a hierarchical manner at week 48 and then at week 24.

Speaker #4: Allowing for both time points to be assessed. The Restore trial is now designed to show a liver benefit over a long period of time and this is consistent with our development strategy of focusing on higher risk patients.

Christophe Arbet-Engels: Demonstrating a liver benefit over a long period of time could be a key differentiator for pemvidutide versus other AUD therapies in development because AUD patients are often already presenting some level of liver impairment. In summary, we are very encouraged by the progress we are making as we move closer to delivering on our mission of helping the millions of patients with serious liver disease. With that, I will turn the call to Linda.

Speaker #4: Demonstrating a liver benefit over a long period of time could be a key differentiator for PEMD versus other AUD therapies in development because AUD patients are often already presenting some level of liver impairment.

Christophe Arbet-Engels: In summary, we are very encouraged by the progress we are making as we move closer to delivering on our mission of helping the millions of patients with serious liver disease. With that, I will turn the call to Linda.

Speaker #4: In summary, we are very encouraged by the progress we are making as we move closer to delivering on our mission of helping the millions of patients with serious liver disease.

Speaker #4: And with that, I will turn the call over to Linda.

Linda Richardson: Thanks, Christophe, and good morning, everyone. In recent quarters, I have shared insights from our market research describing how pemvidutide's target product profile positions us well for future competitiveness in the MASH market. Today, I will focus on how we view the current alcohol use disorder market landscape, how we believe this will evolve in the future, and the potential role of pemvidutide in driving this evolution for patients and healthcare providers. First, the AUD market has considerable untapped potential. Alcohol use disorder is one of the largest under-addressed markets in the US. Approximately 27 million adults meet the criteria for AUD, 12 million of whom are considered to have moderate or severe AUD. It is this group that has the highest risk of progressing to subsequent liver damage, and we believe pemvidutide potentially would bring the most benefit.

Speaker #1: Thanks, Christoph, and good morning, everyone. In recent quarters, I've shared insights from our market research describing how PEMD's target product profile positions us well for future competitiveness in the mesh market.

Speaker #1: Today, I will focus on how we view the current alcohol use disorder market landscape, how we believe this will evolve in the future, and the potential role of PEMAtide in driving this evolution for patients and healthcare providers.

Speaker #1: First, the AUD market has considerable untapped potential. Alcohol use disorder is one of the largest under-addressed markets in the US. Approximately 27 million adults meet the criteria for AUD.

Speaker #1: 12 million of whom are considered to have moderate or severe AUD. It's this group that has the highest risk of progressing to subsequent liver damage, and we believe PEMA due tide potentially would bring the most benefit.

Speaker #1: Overall, only 10% of AUD patients are diagnosed, and of those, only one in four receives drug therapy. It's well known that excessive drinking has direct negative impacts on the liver.

Linda Richardson: Overall, only 10% of AUD patients are diagnosed, and of those, only 1 in 4 receives drug therapy. It is well known that excessive drinking has direct negative impacts on the liver, including cirrhosis, liver failure, and even death. In fact, excessive alcohol consumption is one of the leading causes of preventable liver injury worldwide. The low diagnosis and treatment rates for AUD seem to represent a bit of a disconnect given these health consequences. Why is this? Patient concerns about being stigmatized, low awareness of available drug therapies, less than ideal treatment options with poor compliance that limit prescribing, and no recent therapeutic innovations all contribute to the low diagnosis and treatment rates. There is a clear opportunity for future therapies with new mechanisms and better efficacy and tolerability to help address this dynamic. In fact, there has not been a new drug approved to address AUD in 20 years.

Speaker #1: Including cirrhosis, liver failure, and even death. In fact, excessive alcohol consumption is one of the leading causes of preventable liver injury worldwide. The low diagnosis and treatment rates for AUD seem to represent a bit of a disconnect, given these health consequences.

Speaker #1: Why is this? Patient concerns about being stigmatized, low awareness of available drug therapies, less-than-ideal treatment options with poor compliance that limit prescribing, and no recent therapeutic innovations all contribute to the low diagnosis and treatment rates.

Speaker #1: There is a clear opportunity for future therapies with new mechanisms and better efficacy and tolerability to help address this dynamic. In fact, there has not been a new drug approved to address AUD in 20 years.

Speaker #1: Better solutions often bring renewed interest and growth to therapeutic categories that have been relatively stagnant, as was the case with obesity. We believe strongly that PEMA may bring exactly this type of innovation to the AUD market, particularly for moderate and severe patients.

Linda Richardson: Better solutions often bring renewed interest and growth to therapeutic categories that have been relatively stagnant, as was the case with obesity. We believe strongly that pemvidutide may bring exactly this type of innovation to the AUD market, particularly for moderate and severe patients. The unmet need in the AUD market demands new treatment solutions. The RECLAIM Phase 2 efficacy and tolerability data show pemvidutide's balanced 1-to-1 glucagon GLP-1 activity significantly improved multiple measures of excess drinking and may show positive effects on underlying or subclinical liver impairment in future studies. The potential direct liver benefits that pemvidutide may demonstrate in AUD would provide a strong impetus to prescribe in the moderate and severe patient segments beyond the decrease in drinking levels and behavior. Other products in development may not demonstrate this liver benefit, concentrating more on the cravings and behaviors associated with AUD.

Speaker #1: The unmet need in the AUD market demands new treatment solutions. The reclaimed Phase 2 efficacy and tolerability data show PEMA's balanced one-to-one glucagon GLP-1 activity significantly improved multiple measures of excess drinking, and may show positive effects on underlying or subclinical liver impairment in future studies.

Speaker #1: The potential direct liver benefits that PEMA may demonstrate in AUD would provide a strong impetus to prescribe in the moderate and severe patients segments.

Speaker #1: Beyond the decrease in drinking levels and behavior, other products in development may not demonstrate this liver benefit, concentrating more on the cravings and behaviors associated with AUD.

Speaker #1: Additionally, current AASLD treatment guidelines for MASH strongly encourage alcohol screening, as alcohol consumption accelerates the progression of metabolic dysfunction and increases the risk of liver decompensation, negatively impacting patient outcomes.

Linda Richardson: Additionally, current AASLD treatment guidelines for MASH strongly encourage alcohol screening as alcohol consumption accelerates the progression of metabolic dysfunction and increases the risk of liver decompensation, negatively impacting patient outcomes. We see a potential dynamic emerging where increased alcohol screening and routine PEth testing among liver specialists could substantially increase the diagnosis of AUD even while assessing MASH patients. Recent market research we conducted shows that 44% of hepatologists and 27% of gastroenterologists reported they already use PEth testing in their MASH patients. There is considerable overlap among MASH, AUD, and ALD populations, highlighting the increasing role that the hepatology and gastro communities may play in managing these patients who have or are at risk for serious liver diseases. In summary, the AUD market of today will not be the AUD market of the future.

Speaker #1: We see a potential dynamic emerging where increased alcohol screening and routine PET testing among liver specialists could substantially increase the diagnosis of AUD, even while assessing mesh patients.

Speaker #1: Recent market research we conducted shows that 44% of hepatologists and 27% of gastroenterologists reported they already use PET testing in their mesh patients. There is considerable overlap among mesh, AUD, and ALD populations, highlighting the increasing role that the hepatology and gastro communities may play in managing these patients who have or are at risk for serious liver diseases.

Speaker #1: In summary, the AUD market of today will not be the AUD market of the future. We believe PEMD is well positioned to potentially disrupt this category, providing a catalyst that sets new expectations for what drug therapy can accomplish in the moderate or severe AUD patients who are most at risk for liver damage.

Linda Richardson: We believe pemvidutide is well-positioned to potentially disrupt this category, providing a catalyst that sets new expectations for what drug therapy can accomplish in the moderate or severe AUD patients who are most at risk for liver damage. We look forward to generating additional clinical data to support these beliefs and to share insights from our pre-commercial work along the way. With that, I'll turn it over to Greg for the financial review.

Speaker #1: We look forward to generating additional clinical data to support these beliefs, and to sharing insights from our pre-commercial work along the way. With that, I'll turn it over to Greg for the financial review.

Greg Weaver: Thank you, Linda, and good morning. Starting with our financial results for the quarter, which were in line with our expectations. R&D expense in Q2 2026 was $18.7 million, compared to $17.2 million for the same period prior year. The increase in R&D spend was driven by investment into our ALD trial, as well as start-up costs for the phase III trial in MASH, offset by a decrease in expenses related to the completion of the phase II trial in MASH, which was ongoing in 2025. Q2 2026 R&D spend included $11.6 million of direct costs related to pemvidutide development, of which $3.8 million was for MASH, $5.3 million for the phase II AUD and ALD trials, and $2.5 million in CMC related expenses. Q2 2026 R&D also included $1.1 million in non-cash stock compensation.

Speaker #2: Thank you, Linda, and good morning. Starting with our financial results for the quarter, which were in line with our expectations. R&D expense in Q2, '26 was $18.7 million, compared to $17.2 million for the same period prior year.

Speaker #2: The increase in R&D spend was driven by investment into our ALD trial, as well as startup costs for the Phase 3 trial in mesh.

Speaker #2: Offset by a decrease in expenses related to the completion of the Phase 2 trial in mesh, which was ongoing in 2025. Q2, 2026 R&D spend included $11.6 million of direct costs related to PEMA due tide development, of which $3.8 million was for mesh, $5.3 million for the Phase 2 AUD and ALD trials, and $2.5 million in CMC-related expenses.

Speaker #2: Q2 '26 R&D also included $1.1 million in non-cash stock compensation. G&A expenses in Q2 '26 were $7.6 million, compared to $5.7 million for the same period prior year.

Greg Weaver: G&A expenses in Q2 2026 were $7.6 million, compared to $5.7 million for the same period prior year. The increase in G&A was driven by an increase in professional fees and compensation expenses. The Q2 2026 G&A included $1.7 million in non-cash stock comp. Net loss for the second quarter of 2026 was $22.8 million, or $0.12 a share, compared to a net loss of $22.1 million or $0.27 a share in the second quarter of 2025. Now moving to the balance sheet. Since the beginning of the year, we strengthened our financial position, having raised approximately $310 million year to date, including the $225 million follow-on offering in April. 30 June 2026, total cash was $519 million. This cash position provides us with the operating cash runway through the PERFORMA phase III MASH 52-week data readout, which is expected in 2029.

Speaker #2: The increase in G&A was driven by an increase in professional fees and compensation expenses. The Q2 '26 G&A included $1.7 million in non-cash stock compensation.

Speaker #2: Net loss for the second quarter, '26, was $22.8 million or $0.12 a share, compared to a net loss of $22.1 million or $0.27 a share in the second quarter of 2025.

Speaker #2: Now, moving to the balance sheet: since the beginning of the year, we have strengthened our financial position, having raised approximately $310 million year to date.

Speaker #2: Including the $225 million follow-on offering in April. June 30, 2026, total cash was $519 million. This cash position provides us with the operating cash runway through the pro forma Phase 3 mesh 52-week data readout, which is expected in 2029.

Speaker #2: While our cash runway forecast fully funds the company through the mesh Phase 3 52-week readout, it does not include a potential Phase 3 trial in AUD.

Greg Weaver: While our cash runway forecast fully funds the company through the MASH phase III 52-week readout, it does not include a potential phase III trial in AUD. As we've previously noted, our plan and preference is to use non-dilutive means to fund that trial when needed. On the strength of this data, we believe we'll have the options to fund that trial, which could include royalty, debt, and/or strategic partnerships. With feedback from regulatory authorities, we'll determine the scope and level of investment required for a phase III trial in AUD, and we'll provide the Street with an update as appropriate. Thank you very much. That concludes our prepared remarks, and we'll now turn the call back to the operator for the Q&A session. Operator?

Speaker #2: As we previously noted, our plan and preference is to use non-dilutive means to fund that trial when needed. On the strength of this data, we believe we'll have the options to fund that trial, which could include royalty, debt, and/or strategic partnerships.

Speaker #2: With feedback from regulatory authorities, we'll determine the scope and level of investment required for a Phase 3 trial in AUD, and we'll provide the street with an update as appropriate.

Speaker #2: Thank you very much. That concludes our prepared remarks. And we'll now turn to call back to the operator for the Q&A session. Operator?

Operator: Thank you. Ladies and gentlemen, if you would like to ask a question at this time, you will need to press star one one on your touchtone telephone and wait for your name to be announced. To withdraw your question, simply press star one one again. Please stand by while we compile the Q&A roster.

Speaker #3: Thank you, Lisa, and gentlemen. If you'd like to ask a question at this time, you will need to press *11 on your touchtone telephone and wait for your name to be announced.

Speaker #3: To withdraw your question, simply press star 11 again. Please stand by while we compile the Q&A roster. Our first question coming from the line of Thomas Smith with Learing Partners, Yoland is now open.

Operator: First question coming from the line of Thomas Smith with Leerink Partners. Your line is now open.

Speaker #4: Hey, guys. Good morning. Congrats on all the progress, and thanks for taking our questions. Good morning. On the Phase 3 pro forma study, I appreciate the comments on the regional targeting for the trial sites.

Thomas Smith: Hey, guys. Good morning. Congrats on all the progress.

Thomas Smith: Guys. Good morning. Congrats on all the progress.

Jerome Durso: Good morning, Tom.

Thomas Smith: and thanks for taking our questions.

Thomas Smith: Thanks for taking our questions.

Jerome Durso: Good morning.

Thomas Smith: On the phase III PERFORMA study, appreciate the comments on the regional targeting for the trial sites. I just wanted to ask about your sense of the competitive landscape for MASH trials, since there are a number of competing phase III programs at various stages of enrollment. I was hoping you could provide a bit more detail on how you are targeting study sites with respect to competing programs. How much overlap is there with some of these ongoing pivotal programs? Maybe if you could talk about your expectations on patient enrollment relative to some of the other phase III programs for sema or survodutide or the FGF21s. Then I have a follow-up, if I could.

Speaker #4: I just wanted to ask about your sense of the competitive landscape for MASH trials, since there are a number of competing Phase 3 programs at various stages of enrollment, and I was hoping you could provide a bit more detail on how you're targeting study sites with respect to competing programs.

Speaker #4: How much overlap is there with some of these ongoing pivotal programs? And maybe if you could talk about your expectations on patient enrollment relative to some of the other Phase 3 programs, or SEMA, or serodotide, or the FGF-21s.

Speaker #4: And then I have a follow-up, if I could.

Speaker #1: Okay. Thanks, Thomas. First of all, as we said in the prepared remarks, we're really encouraged by the speed at which we've been able to initiate and the work happening on the ground that Christoph can give you a little color on.

Jerome Durso: Okay. Thanks, Thomas. First of all, as we said in the prepared remarks, we are really encouraged by the speed at which we have been able to initiate and the work happening on the ground that Christophe can give you a little color on. We are operating in an environment where there are some other studies going on, which I think we have been able to work through and take advantage of, frankly, some of the experience out there, both on the CRO side and on the site side as we think about the speed at which we want to enroll. Christophe?

Speaker #1: We are operating in an environment where there are some other studies going on, which I think we've been able to work through and, frankly, take advantage of.

Speaker #1: Some of the experience out there, both on the CRO side and on the site side, as we think about the speed at which we want to enroll.

Speaker #1: Christoph?

Speaker #5: Yes. So we've planned to have a number of sites, as we say, in the range of 290 to 300 sites around the world. We are well aware of the competitive nature of such trials, and what we've built on is a number of factors that are attractive for our study, including the AMASH, the design where we can reduce the screen failures, and also our relationship with the sites, either through our experience in Phase 2 or through our CRO right now.

Christophe Arbet-Engels: Yeah. We've planned to have a number of sites, as we said, in the range of 290 to 300 sites around the world. We are well aware of the competitive nature of such trials, and what we've built on this, a number of factors that are attractive for our study, including the AIM-MASH, the design where we can reduce the screen failures, and also our relationship with the sites, either through our experience in the phase II or through our CRO right now. We also have not expanded the number of patients that we are asking each of those sites to a reasonable number, so that they are able to do additional study as well. So those different features in our consideration for enrollments are really pleasing, I should say, the PIs and the investigators to this point.

Speaker #5: We also have not expanded the number of patients that we are asking each of those sites to a reasonable number, so that they are able to do additional study as well.

Speaker #5: So, really, those different features in our consideration for enrollments are, I should say, really pleasing the PIs and the investigators to this point.

Speaker #5: So we were able to get a really good response on this. Our enrollment is around for studies in that nature between 18 to 24 months.

Christophe Arbet-Engels: We were able to get a really good response on this. Our enrollment is around, for studies in that nature, between 18 to 24 months. Because of these different aspects that we heard, they are very attractive for the PIs. We are aiming at the lower end of this, and that fits well with what we're hearing right now.

Speaker #5: We are because of this different aspects that are we heard they are very attractive for the PIs. We're aiming at the lower end of this and that fits well with what we're hearing right now.

Thomas Smith: Got it. That makes sense. And then a follow-up, if I could, on the RESTORE study in ALD. Could you just elaborate a bit more on the rationale for the protocol amendment and using this hierarchical analysis looking at the 48-week time point before the 24-week time point? Can you comment a bit more on the powering assumptions and what impact the protocol amendment might have on those assumptions? Thanks so much.

Speaker #4: Got it. That makes sense. And then a follow-up if I could on the restore study in ALD. Could you just elaborate a bit more on the rationale for the protocol amendment and using this hierarchical analysis, looking at the 48-week time point before the 24-week time point?

Speaker #4: And can you comment a bit more on the powering assumptions and what impact the protocol amendment might have on those assumptions? Thanks so much.

Speaker #5: Sure. So it doesn't impact anything—this is no change at all in the protocol for this. It's a statistical feature from the AUD data and what we've seen, and the benefits we expect from pemvidutide on the liver.

Christophe Arbet-Engels: Sure. It doesn't impact any. There's no change at all on the protocol for this. It's the statistical features from the AUD data and what we've seen and the benefits we expect from pemvidutide on the liver. For future filing and regulatory filing, we are interested in better characterizing these aspects into the ALD study. So what we're going to be doing is reading at 48 weeks. There is no alpha spending or anything like this with that hierarchical. We were collecting those data anyway. What we're just doing is now being able to analyze both aspects at week 48 and at week 24 in a powered manner using that statistical approach. So it's strengthened, if you wish, the role of this study in our differentiation on the liver benefits.

Speaker #5: For future filing, and regulatory filing, we are interested in better characterizing this aspect into the ALD study in the so what we're going to be doing is reading at 48 week, there is no there is no alpha spending or anything like this with that hierarchical.

Speaker #5: We were collecting those data anyway. What we're just doing is now being able to analyze both aspects at week 48 and at week 24 in the powered manner using that statistical approach.

Speaker #5: So it's strengthened, if you wish, the role of this study in our differentiation on the lever—on the lever benefits.

Jerome Durso: As we indicated in the prepared remarks, Linda went into some detail. We think about the AUD population with the moderate to severe patients. There is, we know, a significant overlap with AUD and ALD in that population. So having the 12-month view around the liver benefit fits consistently with where we see the differentiation of pemvidutide in an area beyond MASH. Thanks, Thomas.

Speaker #1: And as we indicated in the prepared remarks, Linda went into some detail. We think about the AUD population with the moderate to severe patients.

Speaker #1: There is we know a significant overlap with AUD and ALD in that population. So having a 12-month view around the liver benefit fits consistently with where we see the differentiation of PEMV in an area of high unmet need.

Speaker #1: Thanks, Thomas.

Operator: Thank you. Our next question in queue coming from the line of Michael DiFiore with Evercore ISI. Your line is now open.

Speaker #3: Thank you. Our next question in the queue comes from the line of Michael DeFiore with Evercore ISI. Your line is now open.

Speaker #6: Good morning. Thanks so much for taking my questions, guys. A few from me. For AUD, is conducting one global pivotal trial still the base case now that you're incorporating both FDA and EU requirements?

Michael DiFiore: Good morning. Thanks so much for taking my questions, guys. A few from me. For AUD, is conducting one global pivotal trial still the base case now that you are incorporating both FDA and EU requirements? I have a follow-up or two. Thanks.

Speaker #6: And I have a follow-up or two. Thanks.

Christophe Arbet-Engels: Yes. So given the recent guidance, the June guidance from the FDA, we expect that one trial will be sufficient. That guidance talked about the weight of evidence and the quality of the biomarkers. We know that, for example, PathAI is becoming more important. We have those PRO, the WHO RDL, and the zero heavy drinking days that are validated. So our approach is to go with one single trial and to be able to use also our additional experience with pemvidutide in other populations for our safety database. So altogether, we believe that one pivotal phase III in AUD, and potentially ALD patient as well, will be the best approach, and we have some synergies between our different programs.

Speaker #1: Okay.

Speaker #5: Yes. So even the guidance, the recent guidance, the June guidance from the FDA, we expect that one trial will be sufficient. That guidance talk about the weight of evidence and the quality of the biomarkers.

Speaker #5: We know that, for example, PETH is becoming more important. We have those PRO, the WHORDL, and the zero heavy drinking days that are validated.

Speaker #5: So our approach is to go with one single trial and to be able to use also our additional experience with PEMVIDUTIDE in other populations for our safety database.

Speaker #5: So altogether, we believe that one pivotal Phase 3 in AUD and potentially ALD patient as well will be the best approach. And we have some synergies between our different programs.

Speaker #1: And of course, we'll have the expected discussions with the regulators both in the US and in Europe, as we move forward and try to narrow down the assumptions around what Phase 3 is going to look like.

Jerome Durso: And of course, we will have the expected discussions with the regulators both in the US and in Europe as we move forward and try to narrow down the assumptions around what phase III is going to look like.

Jerome Durso: Of course, we will have the expected discussions with the regulators both in the US and in Europe as we move forward and try to narrow down the assumptions around what phase III is going to look like.

Michael DiFiore: Got it. Very helpful. And two follow-ups, if I may. On the RECLAIM call, you were still analyzing the timing of the drug-related discontinuations. Now that some time has passed, do you know whether they clustered around either dose escalation step? Separately, back in March, you said you were active on ex-US partnering, and you since generated the positive AUD data. My question is, has the level of strategic interest changed meaningfully since RECLAIM? Thank you.

Speaker #6: Got it. Very helpful. And two follow-ups, if I may. On the reclaim call, you were still analyzing the timing of the drug-related discontinuations. Now that some time has passed, do you know whether they clustered around either dose escalation step?

Speaker #6: And separately, back in March, you said you were active on XUS partnering. And you since generated the positive AUD data. My question is, has the level of strategic interest changed meaningfully since reclaim?

Speaker #6: Thank you.

Speaker #1: So I'll start on that one and then Christoph can take the second one. I think we've maintained Michael as you know that we're active and open on the front of exploring how best to accelerate and fund the program globally.

Jerome Durso: I will start on that one, and then Christophe can take the second one. I think we have maintained, Michael, as you know, that we are active and open on the front of exploring how best to accelerate and fund the program globally. We continue to maintain the openness and activity on that. We do believe that with this data set in AUD, the potential of pemvidutide has increased. And so we take that into the discussions appropriately with strategics.

Speaker #1: We continue to maintain openness and activity on that. We do believe that with this data set in AUD, the potential of PEMV has increased.

Speaker #1: And so, we take that into the discussions appropriately with strategics.

Speaker #5: Right. With regard to the discontinuation rates, we are still looking in more detail at those data. The discontinuation rate overall was fairly similar between placebo and the active arm.

Christophe Arbet-Engels: Right. With regard to the discontinuation rates, we are still looking in more details at those data. The discontinuation rate overall was fairly similar between placebo and the active arm. It was more related to GI AEs. In the placebo effect, it was to lack of efficacy. This is pretty consistent with what is expected, but we will have more of the details of every single aspect of this in the weeks to come. We are still looking into our final programming, et cetera, to get those data.

Speaker #5: It was more related to GIAs in the placebo effect. It was to lack of efficacy. So this is pretty consistent with what is expected.

Speaker #5: But we'll have more details on every single aspect of this in the weeks to come. We're still looking into our final programming, etc., to get those data.

Speaker #6: Great. Thanks so much.

Michael DiFiore: Great. Thanks so much.

Speaker #5: Thank you.

Christophe Arbet-Engels: Thank you.

Speaker #3: Thank you.

Operator: Thank you.

Speaker #1: Thanks, Michael.

Christophe Arbet-Engels: Thanks, Michael.

Operator: Our next question coming from the line of Roger Song with Jefferies. Your line is now open.

Speaker #3: Our next question coming from the line of Roger Song with Jeffrey. Yoland is now open.

Speaker #7: Hi, guys. This is Peter, author Roger. Congrats on the progress and thanks for taking our question. So two from us. Do you plan to share any subgroup analyses from the reclaim AUD trial?

[Analyst] (Jefferies): Hi, guys. This is Peter on for Roger. Congrats on the progress and thanks for taking our question. So two from us. Do you plan to share any subgroup analyses from the RECLAIM AUD trial? Are there any patient segments where efficacy appears particularly compelling? Second, could you share any additional detail on how you are thinking about phase III timing, trial design, and funding? Thank you.

Speaker #7: And are there any patient segments where efficacy appears particularly compelling? And second, could you share any additional detail on how your thinking about Phase 3 timing, trial design, and funding?

Speaker #7: Thank you.

Christophe Arbet-Engels: Sure. On the sub-analysis, yes. We will be continuing to dig into our data and look at this. We will present these data at future medical conferences, so we will have additional information around this. On the phase III, I shared a little bit in the prepared remarks some of our thoughts right now. I think importantly, again, we are gaining more and more information around the benefits on the liver side. So we want to really establish this in our phase III, given the overlap between our AUD, ALD population. So that is going to be a real factor here that we are going to look into. Also broaden the population a little bit on the BMI sides, given that our phase II had that limitation. So we are looking at a study that is probably, given the current guidance, having a 24-week primary efficacy endpoint.

Speaker #1: Sure. So on the

Speaker #5: sub analysis, yes, we'll be continuing to dig into our data and look at this we'll present this data at future medical conferences. And so we will have additional information around this.

Speaker #5: On the Phase 3, I shared a little bit in the prepared remarks some of our thoughts right now. I think componently, again, we are gaining more and more information around the benefit in the lever side.

Speaker #5: So we want to really establish this in our Phase 3 given the overlap between our AUD, ALD population. So that's going to be a real factor here that we're going to look into.

Speaker #5: And also broaden the population a little bit on the BMI sides given that our Phase 2 had that limitation. So we're looking at a study that's probably given the current guidance having a 24-week primary efficacy endpoint, but we want to look also probably further to get all the way to a 52 weeks with regard to additional analysis.

Christophe Arbet-Engels: Also broaden the population a little bit on the BMI sides, given that our phase II had that limitation. So we are looking at a study that is probably, given the current guidance, having a 24-week primary efficacy endpoint. We want to look also probably further to get all the way to 52 weeks with regard to additional analysis. So we will give more details as we are building this and as we are getting feedback from the regulators.

Christophe Arbet-Engels: We want to look also probably further to get all the way to 52 weeks with regard to additional analysis. So we will give more details as we are building this and as we are getting feedback from the regulators.

Speaker #5: So we'll give more details as we are building this and as we're getting feedback from the regulators.

Speaker #1: Yeah. And on the question of timing, look, we're not yet guiding on timing. We do we're really encouraged by the data. We're going to work quickly and thoroughly on compiling the full data set to answer some of the questions, even that have come across this morning.

Jerome Durso: Yeah, on the question of timing, look, we're not yet guiding on timing. We're really encouraged by the data. We're going to work quickly and thoroughly on compiling the full data set to answer some of the questions, even that have come across this morning. We'll look to package that in a submission to the agencies for an end of phase II, and we'll update you accordingly as you would expect around specific timing. But importantly, the AUD data really creates the opportunity for a liver franchise here. I think you heard this morning, and you'll continue to hear from us about where we see the differentiation not only in MASH but in AUD and really the dual mechanism and the opportunity to impact drinking and impact the liver.

Speaker #1: We'll look to package that in a submission to the agencies for an end of Phase 2. And we'll update you accordingly as you would expect around specific timing.

Speaker #1: But importantly, the AUD data really creates the opportunity for a liver franchise here. I think you heard this morning and you'll continue to hear from us about where we see the differentiation not only in MASH but in AUD and really the dual mechanism and the opportunity to impact drinking and impact the liver.

Jerome Durso: I think you heard this morning, and you'll continue to hear from us about where we see the differentiation not only in MASH but in AUD and really the dual mechanism and the opportunity to impact drinking and impact the liver. Kind of helps us focus on a group of higher-risk patients where we think the benefit of pemvidutide can be unique and different from the other drugs that are potentially available or the ones you know of in development now.

Jerome Durso: Kind of helps us focus on a group of higher-risk patients where we think the benefit of pemvidutide can be unique and different from the other drugs that are potentially available or the ones you know of in development now.

Speaker #1: Kind of helps us focus on a group of higher-risk patients where we think the benefit of PEMV can be unique and different from the other drugs that are potentially available or the ones you know of in development now.

[Analyst] (Jefferies): Great. Thank you.

Speaker #7: Great. Thank you.

Speaker #1: Thanks, Peter.

Jerome Durso: Thanks, Peter.

Speaker #3: Thank you. Our next question coming from the line of Ellie Murley with Barclays. Yoland is now open.

Operator: Thank you. Our next question coming from the line of Ellie Merli with Barclays. Your line is now open.

Ellie Merli: Hey, guys. Thanks for taking the question. Curious your thoughts on how you are thinking about the placebo rate in your MASH phase III study, and can you remind us what your design allows in terms of GLP-1 use at baseline and throughout the study? Then just a second question, I guess what would be good data from the phase II ALD study on liver stiffness next year? Thank you.

Speaker #8: Hey, guys. Thanks for taking the question. I'm curious your thoughts on how you're thinking about the placebo rate in your MASH Phase 3 study.

Ellie Merli: Guys. Thanks for taking the question. Curious your thoughts on how you are thinking about the placebo rate in your MASH phase III study, and can you remind us what your design allows in terms of GLP-1 use at baseline and throughout the study? Then just a second question, I guess what would be good data from the phase II ALD study on liver stiffness next year? Thank you.

Speaker #8: And can you remind us what your desire allows in terms of GLP-1 use at baseline and throughout the study? And then just a second question, I guess, what would be good data from the Phase 2 ALD study on liver stiffness next year?

Speaker #8: Thank you.

Jerome Durso: Okay, great.

Christophe Arbet-Engels: Yeah.

Speaker #5: Yeah. On the placebo, we've built some of some aspects with the with regard to the for example, the AMASH to decrease variability, to decrease the training of pathologies, etc.

Jerome Durso: Hard on MASH.

Christophe Arbet-Engels: On the placebo, we built some aspects with regard to, for example, the AIM-MASH to decrease variability, to decrease the training of pathologists, et cetera. We are reading at 52 weeks. We think that for the MASH study, that analysis for the accelerated approval will give us what we are expecting with regard to the anti-fibrotic effect that we are seeing. The GLP-1 use is accepted in our study, the antidiabetic doses. We will include also diabetic patients in that particular study, as long as they are on GLP-1 or other therapies that are limited to their antidiabetic doses. I think you had a question on the. Sorry, I am blanking to the.

Speaker #5: So and we're reading at 52 weeks. So we think that for the MASH study that analysis for the accelerated approval, we'll give us what we are expecting with regard to the antifibrotic effect that we're seeing.

Speaker #5: The GLP-1 use is accepted in our study. The anti-diabetic doses and so we will include also diabetic patients in that particular study as long as they are on GLP-1 or other therapies that are limited to their anti-diabetic doses.

Speaker #5: And then I think you had a question on the sorry, I'm blinking.

Jerome Durso: ALD. I think ALD expectations on the ALD data.

Speaker #1: ALD expectations on the ALD data.

Speaker #5: Oh, what would be the good on the ALD? Well, we are looking forward to see and we believe that exactly by now being able to read both at 48 week and 24 week that we will be able to clearly characterize the liver benefit effect of PEMV dutide through this longer treatment all the way to one year duration and this will be very helpful in our discussion with regulators.

Christophe Arbet-Engels: Well, it would be good on the ALD. We are looking forward to see, and we believe that exactly by now being able to read both at 48 week and 24 weeks, that we will be able to clearly characterize the liver benefit effect of pemvidutide through this longer treatment all the way to one-year duration. This will be very helpful in our discussions with regulators. A study that would deliver this would be obviously a very positive study for us.

Speaker #5: So a study that would deliver this would be obviously a very positive study for us.

Speaker #1: And remember, in that study, we're also capturing all the expected impact of reduced drinking. Which I think, when we look at the population in that ALD study, we know at baseline, heavy drinking is ongoing.

Jerome Durso: Remember, in that study, we are also capturing all the expected impact of reduced drinking, which I think when we look at the population in that ALD study, we know at baseline heavy drinking ongoing. Again, just reinforcing that overlap that exists between AUD and ALD. Great. Thanks. Thanks, Ellie.

Speaker #1: So again, just reinforcing that overlap that exists between AUD and ALD.

Speaker #8: Great. Thanks.

Speaker #1: Thanks, Ellie.

Speaker #3: Thank you. Our next question coming from the line of Kripa Devarkonda with Truist Securities. Yoland is now open.

Operator: Thank you. Our next question coming from the line of Srikripa Devarakonda with Truist Securities. Your line is now open.

Srikripa Devarakonda: Hey, guys. Thank you so much for taking my question, and congratulations on the progress this quarter. I have a couple of questions. One is on AUD. Can you remind us what percentage of AUD patients are overweight or obese, and how this might play into your Phase III planning? Does it make sense to focus on demonstrating dual benefit of weight loss and drinking reduction to appeal to payers? Also, if I heard it correctly, you plan to have a cohort based on BMI less than 25. Going back to the MASH study, that is my second question. Do you have any MRI DXA substudies in PERFORMA to support a specific lean mass preservation, which is something that you have shown in your Phase II study, claim on the label, or is this mainly something that you would use for messaging, assuming the drug is approved? Thank you.

Speaker #8: Hey, guys. Thank you so much for taking my question and congratulations on the progress this quarter. I have a couple of questions. One is on AUD.

Srikripa Devarakonda: Guys. Thank you so much for taking my question, and congratulations on the progress this quarter. I have a couple of questions. One is on AUD. Can you remind us what percentage of AUD patients are overweight or obese, and how this might play into your phase III planning? Does it make sense to focus on demonstrating dual benefit of weight loss and drinking reduction to appeal to payers? Also, if I heard it correctly, you plan to have a cohort based on BMI less than 25. Going back to the MASH study, that is my second question. Do you have any MRI DXA substudies in PERFORMA to support a specific lean mass preservation, which is something that you have shown in your phase II study, claim on the label, or is this mainly something that you would use for messaging, assuming the drug is approved? Thank you.

Speaker #8: Can you remind us what percentage of AUD patients are overweight or obese and how this might play into your Phase 3 planning? Does it make sense to focus on demonstrating dual benefit of weight loss and drinking reduction to appeal to payers?

Speaker #8: And also, if I heard it correctly, you plan to have a cohort based on BMI less than 25. And going back to the MASH study, that's my second question.

Speaker #8: Do you have any MRI, DEXA sub-studies in proforma to support a specific lean mass preservation, which is something that you've shown in your Phase 2 study claim on the label?

Speaker #8: Or is this mainly something that you would use for messaging assuming the drug is approved? Thank you.

Jerome Durso: So we will try to hit them off here, Kripa, because you gave us a bunch.

Speaker #1: So we'll try to take them off here, because you gave us a bunch.

Jerome Durso: We will try to hit them off here, Kripa, because you gave us a bunch.

Srikripa Devarakonda: Series of quick.

Speaker #8: Series. I can go back to the questions.

Jerome Durso: First on PERFORMA.

Srikripa Devarakonda: I can go back to the questions.

Speaker #1: Yeah. First, I was writing quickly, but thanks. First on proforma, we have as we've said before, we are doing work as part of the overall program, which will allow us to better characterize some of the impact on body composition in the MASH population.

Jerome Durso: Yeah. First, I was writing quickly, but thanks. First, on PERFORMA, as we've said before, we are doing work as part of the overall program, which will allow us to better characterize some of the impact on body composition in the MASH population. Again, we think doing that as part of the phase III might give us some opportunity on the labeling side if everything goes in the direction. Maybe Linda, you can comment on some of the concomidency, I think the question around the overweight and obesity. You did hear, Kripa, Christophe correctly. We do anticipate including patients in a potential phase III on AUD that were below the 25 BMI, and that will be part of the construction of the trial and the dialogue. Linda, maybe you want to talk about the concomidency.

Speaker #1: And again, we think doing that as part of the Phase 3 might give us some opportunity on the labeling side if everything goes in the direction.

Speaker #1: Maybe Linda, you can comment on some of the concomitancy, I think the question around the overweight and obesity. You did hear Kripa Christoph correctly.

Speaker #1: We do anticipate including patients in a potential Phase 3 on AUD that were below the 25 BMI; that will be part of the construction of the trial and the dialog.

Speaker #1: Linda, maybe you want to talk about the concomitancy.

Speaker #7: Yeah. I think depending on the source, you see upwards to practically two-thirds of patients having overweight, not necessarily obesity, but a combination of those.

Linda Richardson: Yeah, I think depending on the source, you see upwards to practically two-thirds of patients having overweight, not necessarily obesity, but a combination of those. So a safe assumption is at least half, because we know what the rates are in the general population, and we see that drinking can contribute to excess weight. There is also, obviously in some of the more severe populations, particularly in ALD, they actually have some lean drinking. They have caloric restriction issues because they are drinking and have other issues. But the benefits, and we talked to some preliminary market access payer work. The losing of weight can be helpful to them as a sign, but really the reductions in drinking and the impact on the liver and the potential to address that.

Speaker #7: So a safe assumption is at least half because we know what the rates are in the general population. And we see that drinking can contribute to excess weight.

Speaker #7: There's also obviously in some of the more severe populations, particularly in ALD, they actually have some lean drinking. They have caloric restriction issues because they're drinking and have other issues.

Speaker #7: But the benefits that we talk to—some preliminary market access payer work—the losing of weight can be helpful to them as a sign, but really the reductions in drinking and the impact on the liver, and the potential to address that.

Speaker #7: Here you have something that not only is in PEMV, something that is not only addressing the cause of the issue, but the damage to the liver potentially.

Linda Richardson: Here you have something that not only is, in pemvidutide, something that is not only addressing the cause of the issue, but the damage to the liver, potentially. That is what we are really interested in exploring on that back end, hence the discussion on the ALD timelines and where we are looking at a 48-week readout. All of these things that differentiate us make us highly relevant to the population that needs the most help. That is really where we are focusing on that idea, because there has never been something that really is doing both in the AUD population. That is really resonating with, I would say, patients, prescribers, and payers.

Speaker #7: And that's what we're really interested in exploring on that back end. Hence the discussion on the ALD, timelines and where we're looking at a 48-week readout.

Speaker #7: All of these things that. Differentiate us, make us highly relevant to the population that needs the most help. And that's really where we're focusing.

Speaker #7: And that idea, because there's never been something that really is doing both in the AUD population, that is really resonating with, I would say, patients, prescribers, and payers.

Speaker #1: And I think that's why we view the AUD dataset we just reported out as so robust and de-risking, because we get clarity across all of the endpoints, including the two approvable endpoints.

Jerome Durso: I think that is why we view the AUD data set we just reported out as so robust and de-risking. Because we get clarity across all of the endpoints, including the two approvable endpoints. We have a clear impact at 24 weeks on drinking across those, on weight in a population where, again, up to two-thirds of them are overweight or obese, and the signals on the liver, which we will explore more deeply in phase III. So we think we are in a good position to understand what pemvidutide can really bring in uniquely in this high-risk segment.

Speaker #1: We have a clear impact at 24 weeks on Tranzulectin, across those, on weight in a population where, again, up to two-thirds of them are overweight or obese.

Speaker #1: And the signals on the liver, which we'll explore more deeply in Phase 3. So we think we're in a good position to understand what PEMV can really bring in uniquely in this high-risk segment.

Srikripa Devarakonda: Great. Thanks for getting all of them. Thanks a lot.

Speaker #8: Great. Thanks for getting all of them. Thanks a lot.

Speaker #1: Thanks, Kirk.

Jerome Durso: Thanks, Kripa.

Operator: Thank you. Our next question coming from the line of Annabel Samimy with Stifel. Your line is now open.

Speaker #3: Thank you. Our next question coming from the line of Annabelle Sumimi with Steve Foley. Yoland is now open.

Annabel Samimy: Hi, thanks for taking my question. I am curious about the follow-up from the AUD study. I think it is pretty well known that with the weight loss drugs, there is rebound when patients stop taking the injections, and there are persistence problems. When you think about AUD, has there been any follow-up study on these patients to see how they behave after they stop treatment? Is there a rebound in their heavy drinking? Is there any work being done in trying to maintain a persistence of treatment on this drug? Have you noticed anything with any of the other incretins where they have removed treatment and then there is rebound in the alcohol use? Just one question on that, and then if you could just give us some clarity on the powering assumptions for ALD. Thank you.

Speaker #7: Hi. Thanks for taking my question. So I'm curious about the follow-up from the AUD study. So I think it's pretty well known that with the weight loss drugs, there's rebound when patients stop taking the injections and there's persistence problems.

Speaker #7: And so when you think about AUD, has there been any follow-up study on these patients to see how they behave after they stop treatment?

Speaker #7: Is there a rebound in their heavy drinking? And is there any work being done in trying to maintain the persistence of treatment on this drug?

Speaker #7: And have you noticed anything with any of the other incretins where they remove treatment and there's rebound in the alcohol use and just one question on that.

Speaker #7: And then if you could just give us some clarity on the powering assumptions for ALD. Thank you.

Speaker #8: So let me start on what the competitive context is with rebound. What has happened more often is that patients cannot tolerate those therapies and are falling off.

Linda Richardson: Well, let me start on what the competitive context is with rebound. What has happened more often is that patients cannot tolerate those therapies and are falling off. That is a major issue and part of the reason that you saw an injectable come out with VIVITROL to try and get compliance and staying on drug to help give the most benefit. That still is an unmet need, and again, when you reflect on the tolerability overall that we have seen with pemvidutide, we believe that that also positions us very well as we study in various therapeutic areas here. We think that that is an advantage for us.

Speaker #8: And that is a major issue and part of the reason that you saw an injectable come out with Vivitrol to try and get compliance and staying on drug to help give the most benefit.

Speaker #8: So that still is an unmet need. And again, when you reflect on the tolerability overall that we've seen with PEMV, we believe that that also positions us very well as we study in various therapeutic areas here.

Speaker #8: We think that that is an advantage for us. In terms of, I think, following up on our own study results, I think we haven't had a chance even to do that.

Linda Richardson: In terms of, I think, following up on our own study results, I think we have not had a chance even to do that. I will defer to Christophe to look at that because I know we have not looked at all the data sets yet.

Speaker #8: And I'll defer to Christoph to look at that because I know we don't even we haven't looked at all the data sets yet.

Christophe Arbet-Engels: Exactly, Linda. Thanks. The study was not designed to look at a formal assessment of rebound. We have a follow-up period that we are going to get some information. We will look into that. I think, again, to the point Linda made, having a drug that people can take chronically, take on the long term, I think even the guidance from the FDA relates to the fact that this is a chronic disease. This is not just a temporary disease, and the treatment needs to be evaluated chronically, bodes well with the safety and tolerability that we have seen with pemvidutide. This is something we will be able to look a little further in our phase III and over longer duration. With regard to power assumptions for ALD, we will power the study north of 90%. A single trial needs to be powered like this.

Speaker #2: And exactly, Linda, thanks. The study was not designed to look at a formal assessment of rebound. We have a follow-up period that we're going to get some information.

Speaker #2: We'll look into that. I think, again, to the point Linda made, having a drug that people can take chronically take on the long term, I think even the guidance from the FDA relates to the fact that this is a chronic disease.

Speaker #2: This is not just a temporary disease, and the treatment needs to be evaluated chronically, both with the safety and tolerability that we have seen with PEMV.

Speaker #2: So this is something we'll be able to look at a little further in our Phase 3 and over a longer duration. With regard to power assumptions for ALD, we will power the study.

Speaker #2: North of 90%, the single trial needs to be powered like this. We will have like we discussed, the typical AUD with already some damage in the liver whether they know it or not, similar to what we've seen in our Phase 2.

Christophe Arbet-Engels: We will have, like we discussed, the typical AUD with already some damage in the liver, whether they know it or not, similar to what we have seen in our phase II, and we will have also ALD population, and we will make sure that this is powered adequately. We will have those discussions with the regulators, and we will be able to design the study so that it supports the indication for these populations.

Speaker #2: And we'll have also ALD population and we'll make sure that this is powered adequately. We'll have those discussions with the regulators. And we'll be able to design the study so that it supports the indications for these populations.

Annabel Samimy: Great. Thank you.

Speaker #8: Great. Thank you.

Speaker #2: Thank you.

Christophe Arbet-Engels: Thank you.

Speaker #3: Thank you. Our next question coming from the line of Catherine Okokoni with Citizens. Yoland is now open.

Operator: Thank you. Our next question coming from the line of Catherine Okoukoni with Citizens. Your line is now open.

Speaker #5: Thank you, sir. Starting the Phase 3 programs in AUD especially, considering it's not fully funded, while leveraging the ongoing Phase 3 MASH trial—when would you decide to allocate additional funds, and what would you need to see to do that?

Catherine Okoukoni: Starting the phase III programs in AUD especially, considering it is not fully funded while leveraging the ongoing phase III MASH trial. When will you decide to allocate additional funds, and what would you need to see to do that?

Jerome Durso: Hey, maybe Greg, you can jump in, I think. I am sorry, you cut out a little bit on our end, but I believe the question is around how we are thinking about financing on the AUD side.

Speaker #1: Okay, maybe Greg, you can jump in. I think, and I'm sorry—you cut out a little bit on our end—but I believe the question is around how we're thinking about financing on the AUD side.

Jerome Durso: Maybe Greg, you can jump in, I think. I am sorry, you cut out a little bit on our end, but I believe the question is around how we are thinking about financing on the AUD side.

Speaker #2: Yeah, thanks. Greg here, and I appreciate the question. So, yeah, the strength of this Phase 2 data in AUD presents us with an opportunity for Phase 3.

Greg Weaver: Yeah, thanks. Greg here, and I appreciate the question. This strength of this phase II data in AUD presents us with an opportunity for phase III. Next steps, as was teased out earlier in the call, will be feedback from FDA on the end of phase II meeting. That will allow us then to step back and sketch out and design the blueprint for the size and scope of that phase III, costing that out. Clearly anticipate that will be quite a bit less costly than a MASH phase III would be. With that design, would then be in a position to finance that in the new year and anticipate that the preference would continue to be for non-dilutive funding. Those options could include a combination of strategic monies and/or debt or royalty, et cetera. Again, highly confident that that is a program that is fundable.

Speaker #2: So next steps as was teased out earlier in the call will be feedback from FDA on the end of Phase 2 meeting, and that will allow us then to step back and just sketch out and design the blueprint for the size and scope of that Phase 3, costing that out.

Speaker #2: Clearly, we anticipate that will be quite a bit less costly than a MASH Phase 3 would be. And with that design, we would then be in a position to finance that in the new year, and anticipate that the preference would continue to be for non-dilutive funding.

Speaker #2: Those options could include a combination of strategic money and/or debt or royalty, etc. So again, highly confident that that's a program that's fundable. And again, just a reminder, we reported June 30 cash of $519 million.

Greg Weaver: And again, just to remind, we reported 30 June cash $518 million. That is runway through the MASH phase III readout top line in 2029. So again, takeaway message there is a strong balance sheet today, great opportunities for the second great indication and a second phase III to build out the franchise.

Greg Weaver: Again, just to remind, we reported 30 June cash $518 million. That is runway through the MASH phase III readout top line in 2029. So again, takeaway message there is a strong balance sheet today, great opportunities for the second great indication and a second phase III to build out the franchise.

Speaker #2: That's runway through the MASH Phase 3 readout, top-line, in 2029. So again, the takeaway message there is a strong balance sheet today. Great opportunities for the second great indication in a second Phase 3 to build out the franchise.

Operator: Thank you. Our next question in queue coming from the line of Patrick Trucchio with H.C. Wainwright. Your line is now open.

Speaker #3: Thank you. And our next question in the queue comes from the line of Patrick Drukio with HC Wainwright. Your line is now open.

Speaker #6: Thanks. Good morning. Just a few follow-up questions on PERFORM and MASH. I was wondering, first, if there was a read-through or learnings from the Phase 2 ReCLAIM trial in AUD around the 2.4 mg discontinuations, and how that might change titration, monitoring, or dose reduction plans for the 2.4 mg arm in PERFORM?

Patrick Trucchio: Thanks. Good morning. Just a few follow-up questions on PERFORMA and MASH. I was wondering first if there was a read-through or learnings from the phase II RECLAIM trial in AUD around the 2.4 milligram discontinuations and how that might change titration monitoring or dose reduction plan for the 2.4 milligram arm in PERFORMA. And then as well in PERFORMA, I am wondering if you are going to be allowing background GLP-1 therapy, resmetirom, or other gastric-directed therapies, and how you could manage patients who want to initiate or resume those therapies during the 52-week biopsy period. And then just lastly, can you detail a bit more about AIM-MASH, exactly how AIM-MASH AI Assist will be incorporated into the pathology workflow and just sort of the operational metrics around this?

Speaker #6: And then as well in Performa, I'm wondering if you're going to be allowing background GLP-1 therapy resveratram or other directed therapies and how you could manage patients who want to initiate or resume those therapies during the 52-week biopsy period.

Speaker #6: And then just lastly, can you detail a bit more about a MASH exactly how a MASH AI assist will be incorporated into the pathology workflow and just sort of the operational metrics around this?

Speaker #6: Sure. Yeah. So, to the first point on the titration and the learnings from the AUD trial for the 2.4 milligram, yes, we have learned that in that particular population, the monthly titration is a simple step that is a couple of steps, and it's favorable with regard to, in particular, nausea and vomiting.

Christophe Arbet-Engels: Sure. Yeah. So to the first point on the titration and the learnings from the AUD trial for the 2.4 milligram, yes, we have learned that in that particular population, the monthly titration is a simple step that is a couple of steps, and it is favorable with regard to, in particular, nausea and vomiting. So I think the direction is very supportive to move for the 2.4, and we will have a one step for going to the 1.8 milligram and the two steps to go to the 2.4. So very simple, easy titration. So those are consistent learnings from the AUD trials applying into the PERFORMA Phase III. With regard to GLP-1 and as mentioned, or resmetirom, as mentioned before, the GLP-1 will be tolerated only at antidiabetic levels.

Speaker #6: So I think the direction is very supportive to move forward to the 2.4, and we'll have one step for going to the 1.8 milligram and then two steps to go to the 2.4.

Speaker #6: So, very simple, easy titration. So those are consistent learnings from the AUD trials applying into the Performa Phase 3. With regard to GLP-1 and, as mentioned, oresmitirone...

Speaker #6: As mentioned before, the GLP-1 will be tolerated only at anti-diabetic levels. The oresmitirone will not be included in the trial in order to not geopodize our primary endpoint with regard to the 52 weeks readout on the biopsy.

Christophe Arbet-Engels: The resmetirom will not be included in the trial in order to not jeopardize our primary endpoint with regard to the 52 weeks readouts on the biopsy. We will collect history of patients that do have failure on GLP-1, resmetirom, et cetera, who have not improved and not tolerated this. So we will be able to characterize the population and understand which were, I would call, treatment failures for those particular therapies. With regard to the AIM-MASH AI Assist, the way it works is basically the slides that are taken from the biopsy are stained, and then they are digitalized. The program on the AIM-MASH AI Assist will point to the features based on that AI system, propose a score, and the pathologist will be able to look at those and agree or disagree with the scoring or with the evaluation on certain aspects.

Speaker #6: We will collect history of patients that do have failure on GLP-1, Oresmitirone, etc., who have not improved or not tolerated this. So we'll be able to kind of characterize the population and understand which were, I would call, treatment failures for those particular therapies.

Speaker #6: And with regard to the AMASH assist, the way it works is basically the slides that are taken from the biopsy are stained and then they're digitalized.

Speaker #6: Now, the program on the a MASH assist will point to the features based on that AI system propose a score and the pathologist will be able to look at those and agree or disagree with the scoring or with the evaluation on certain aspects.

Christophe Arbet-Engels: Given it is a consensus reading at the end as per the FDA requirement, the pathologists are responsible for the scoring. PathAI claims that it improves viability and improves consistency between pathologists. We have already put in place additional aspects to make sure that we have that consistency between training, harmonization, and using charters and alignment on how to read the slide. All these features, we hope, will decrease any variability, improve consistency in the reading, and help, not only in the enrollment phase to decrease the screen fail patients, but also in the efficacy reading to have less variability around the reading. Put together, this is the first, again, PERFORMA is the first phase III trial with the AIM-MASH AI Assist. There is quite a lot of excitement around this from the sites, as we have heard.

Speaker #6: And given it's a consensus reading at the end as per the FDA requirement, the pathologists are responsible for the scoring. But PathAI claims that it improves variability and improves consistency between pathologists.

Speaker #6: We've already put in place additional measures to ensure that we have consistency between training, harmonization, and using charters, as well as alignment on how to read the slides.

Speaker #6: So all these feature we hope will decrease any variability, improve consistency in the reading, and help not only in the enrollment phase to decrease the screen failed patients, but also in the efficacy reading to have less variability around the reading.

Speaker #6: So put together, this is the first, again, Performa is the first Phase 3 trial with the a MASH assist and there's quite a lot of actually excitement around this from the sites as we've heard.

Patrick Trucchio: Just on the RECLAIM, if I can add a few additional follow-ups. Just in terms of durability of the AUD effect, do you have any sense of whether the treatment effect was early and durable, and will you eventually have this data? On the phase III endpoint selection, I think you noted that two-level World Health Organization Risk Drinking Level reduction, zero heavy drinking days are the FDA recognized registrational endpoints. Which one, or is there a preferred primary endpoint, and would heavy drinking days be supportive or primary? Just lastly, on the AUD phase III population, you mentioned broadening the phase III AUD population to include BMI below 25 and potentially lower dose options.

Speaker #7: And then just on the reclaim,

Speaker #6: If I can add a few additional follow-ups—just in terms of the durability of the AUD effect, do you have any sense of whether the treatment effect was early and durable?

Speaker #6: And will you eventually have this data? And then on the Phase 3 endpoint selection, or would you eventually share that data? And then on the Phase 3 endpoint selection, I think you noted that two-level World Health Organization risk drinking level reduction, zero heavy drinking days are the FDA recognized registrational endpoints.

Speaker #6: Which one—or is there a preferred primary endpoint? And would heavy drinking days be supportive or primary? And then just lastly, on the AUD Phase 3 population, you mentioned broadening the Phase 3 AUD population to include BMI below 25 and potentially lower dose options.

Speaker #6: What's the rationale for those changes and would the Phase 3 trial include both AUD only and AUD ALD overlap patients? Thank you. So on the durability of the AUD, we have some elements in our data that show that there was no plateau of the effect after 24 weeks.

Patrick Trucchio: What is the rationale for those changes, and would the phase III trial include both AUD only and AUD/ALD overlap patients? Thank you.

Christophe Arbet-Engels: On the durability of the AUD, we have some elements in our data that show that there was no plateau of the effect after 24 weeks. Clearly we are going to continue to explore this in the phase III, which will go all the way through 52 weeks, and is needed anyway for the safety database. We will have that information, but it is expected, for example, even on the weight loss and other aspects on the path, on the number of abstinent days, for example, to continue improving these patients and the chronic exposure to pemvidutide is really important to assess. On the phase III endpoints, we are lucky enough in our RECLAIM study to have a validation of both. Obviously, we are powering, we are going to select one and align with the regulators. Keep in mind that very often the regulators will look at both.

Speaker #6: So clearly, we're going to continue to explore this in the Phase 3, which will go all the way through 52 weeks and is needed anyway for the safety database.

Speaker #6: So we'll have that information, but it is expected, for example, even on the weight loss and other aspects, on the PATH, on the number of abstinence days, for example, to continue improving these patients and the chronic exposure to pavidocide is really important to assess.

Speaker #6: On the Phase 3 endpoint, we're lucky enough in our Reclaim study to have a validation of both. Obviously, we're powering, we're going to select one and align with this with the regulators. Keep in mind that very often, the regulators will look at both.

Speaker #6: So we have also the options to power fully for both more likely into one primary endpoint, one key secondary endpoint, something in that nature, in the way to look at it.

Christophe Arbet-Engels: We have also the options to power fully for both, more likely into one primary endpoint, one key secondary endpoint, something in that nature in the way to look at it. But the zero heavy drinking days or the WHO RDL will be the endpoint that we will be clearly looking at. And the population with regard to lower dosing or extending to BMI below 25, as Linda said, originally there is two-third of the population that are overweight and have AUD. There is an overlap between these two aspects. But there is also another third that is not overweight. We believe we can address that population by doing this. These patients may require less exposure or the current 2.4 could be very efficacious. But in some patients, a lower dose could be sufficient. We need to evaluate this during our phase III.

Speaker #6: But the zero heavy drinking days or the WHO RDL will be the endpoint that we'll be clearly looking at. And the population, with regard to lower dosing or extending to BMI below 25, as Linda said, originally there's two-thirds of the population that are overweight and have AUD.

Speaker #6: There's an overlap between these two aspects, but there's also another third that is not overweight. So, we believe we can address that population by doing this. These patients may require less exposure, or the current 2.4 could be very efficacious, but in some patients, a lower dose could be sufficient.

Speaker #6: So we need to evaluate this during our Phase 3. We believe a couple of doses will be an approach that will allow us to better characterize how to distinguish in these different populations and have a broad picture with all the details that we need when we discuss with the regulators at filing.

Christophe Arbet-Engels: We believe a couple of doses will be something, an approach that will allow us to better characterize how to distinguish in this different population and having a broad picture with all the details that we need when we discuss with the regulators for that filing.

Jerome Durso: Terrific. Thanks so much.

Speaker #6: Terrific. Thanks so much. Thank you.

Christophe Arbet-Engels: Thank you.

Jerome Durso: Thanks.

Speaker #7: Thanks.

Speaker #1: Thank you. Our next question is coming from the line of William Woodward with Reilly Securities. Your line is now open.

Operator: Thank you. Our next question coming from the line of William Wood with B. Riley Securities. Your line is now open.

William Wood: Hi. Yes, thanks for taking our questions. Just looking back over the past year and sort of the changes in some of the ALD inclusion requirements, it looks like you have increased your liver stiffness that you are allowing into the trial from about 18.5 up to about 25. I was wondering if you could speak to sort of how you expect that or why or that change may have been occurring. Possibly being able to provide any details on how the inclusion of severe, less severe population, and if that led into anything to do with the change in hierarchy for your primary endpoint. I know you said that you were going to be evaluating both, but it does seem to be a semi-hierarchical. Then follow-up question or secondary question.

Speaker #7: Hi, yes. Thanks for taking our questions. So just looking back over the past year and sort of the changes in some of the ALD inclusion requirements, it looks like you've increased your liver stiffness that you're allowing into the trial from about 18 and a half up to about 25.

Speaker #7: I was wondering if you could speak to, sort of, how you expect that, or why that change may have been occurring—possibly being able to provide any details on how the inclusion of severe or less severe populations, and if that led into anything to do with the change in hierarchy for your primary endpoint.

Speaker #7: I know you said that there was you're going to be evaluating both, but it does seem to be a semi-hierarchical. And then follow-up question or secondary question, at least for your AUD trial, I know we're expecting I believe brineptatide will be reading out in 2028.

William Wood: At least for your AUD trial, I know we are expecting, I believe, bimagrumab will be reading out in 2028, which is obviously has the GIP 1. I was just curious how we should be thinking about, at least in drinking reduction, the differences that may occur with GIP versus a glucagon component added on. Thanks.

Speaker #7: So, which obviously has the GIP-1. So I was just curious how we should be thinking about, at least in drinking reduction, the differences that may occur with GIP versus a glucagon component add-on.

Speaker #7: Thanks.

Speaker #6: Yep. I'll start on the LSM on the liver stiffness criteria inclusion criteria. These are not related at all to the change in reading of primary endpoint that week 48 with the hierarchical procedure.

Christophe Arbet-Engels: Yep. I'll start on the LSM, on the liver stiffness criteria, inclusion criteria. These are not related at all to the change in reading of primary endpoint at week 48 with the hierarchical procedure. The hierarchical procedure, as I mentioned, is directly focused on strengthening our understanding of pemvidutide's beneficial effect on the liver and supporting further discussions with the regulator. The criteria and the amendment that we've had was actually related to a study that we've made as an hepatic impairment study that allowed us to now expand to those patients and broaden that criteria. As you can imagine, every time we do developments, we have a number of learnings, and we were able to implement the learnings from the hepatic impairment study that didn't show any risk in the population, and we were able to expand and broaden the criteria.

Speaker #6: The hierarchical procedures I mentioned is directly focused on strengthening our understanding of pavidocide's beneficial effect on the liver and supporting further discussions with the regulator.

Speaker #6: The criteria and the amendment that we've had was actually related to a study that we've conducted as a hepatic impairment study. That allowed us to now expand to those patients and broaden that criteria.

Speaker #6: So as you can imagine, every time we do developments, we have a number of learnings and we were able to implement that. The learnings from the hepatic impairment study that didn't show any risk in the population and we were able to expand and broaden the criteria.

Christophe Arbet-Engels: With regard to the AUD and the bimagrumab, we're looking forward to see this data. I think what, again, bimagrumab is a GLP-1 GIP. It doesn't have the liver effect, so it's probably similar to what you see with GLP-1 semaglutide. To that extent, maybe a little different because of the GIP component, but the direct liver impact, we believe, is important. We've heard from our KOL that it's really, for them, what they call a game-changing approach if you're able to treat the patients that have AUD and may not even know they already have liver steatosis, inflammations, or be even having fibrosis. So pemvidutide fits really well in that population, and that's what we want to build on.

Speaker #6: With regard to the AUD and the brineptatide, we're looking forward to seeing this data. I think, again, brineptatide is a GLP-1 GIP. It doesn't have the liver effect.

Speaker #6: So it's probably similar to what you see with GLP-1 semaglutide, thanks to that extent, maybe a little different because of the GIP component. But the direct liver impact, we believe, is important.

Speaker #6: We've heard from our KOL that it's really, for them, what they call a game-changing approach if you're able to treat the patients that have AUD and may not even know they already have liver steatosis, inflammations, or may even be having fibrosis.

Speaker #6: So pavidocide fits really well in that population and that's what we want to build on.

Speaker #2: Yeah, I think they're also looking at earlier patients, the mild segment.

Linda Richardson: Yeah, I think that.

William Wood: Thanks

Linda Richardson: They're also looking at earlier patients, the mild segment.

Christophe Arbet-Engels: Yep.

Speaker #6: Yeah.

Speaker #7: Thanks for the question. Operator, are there any more?

Jerome Durso: Thanks for the question. Operator, are there any more?

Speaker #1: Yes, we have one more question in the queue. The last questioner will come from the lineup. And if you're with William Blair, your line is now open.

Operator: Yes, we have one more question in queue. Last questioner will come from the line of Andy Hsieh with William Blair. Your line is now open.

Speaker #7: Okay, thanks for squeezing me in. So maybe one more on the RESTORE study and about liver stiffness. So the upper end of that range, 10 to 25, the upper range is suggestive of cirrhotic features for these patients.

Andy Hsieh: Oh, great. Thanks for squeezing me in. So maybe one more on the RESTORE study and about liver stiffness. The upper end of that range, 10 to 25. The upper range is suggestive of cirrhotic features for these patients. I am curious if the data is supportive in that segment, and how would you use that data, potential read-throughs to other indications. Basically generating more data for pemvidutide in the cirrhotic patient population. Thank you.

Speaker #7: I'm curious, if the data is supportive in that segment, how would you use that data—potential read-throughs to other indications? Basically, generating more data for PEM in the cirrhotic patient population.

Speaker #7: Thank you.

Speaker #6: Thank you for the question. So, on the liver stiffness, as you know, there is a little bit of variability in that range. So you're correct.

Christophe Arbet-Engels: Thank you for the question. On the liver stiffness, as you know, the range, there is a little bit of variability there. So you are correct. We may include a very small or minor population of patients that are a little more advanced, closer to the cirrhotic stage. We know the drug is safe because we have done the hepatic impairment, as mentioned before. We know that in this population, we are going to be okay. I think we will have the opportunity to include those patients in our phase III and look at the AUD. But in the meantime, it is important. Again, one piece that in this population is happening is over a certain period of time, from a regulatory perspective, it will be important to show that even if patients advance or if they are worsening, we can address this population.

Speaker #6: We may include a very small or minor population of patients that are a little more advanced, closer to the cirrhotic stage. We know the drug is safe because we've done the hepatic impairment study, as mentioned before.

Speaker #6: We know that in this population, we're going to be okay. I think we will have the opportunity to include those patients in our Phase 3 and look at the AUD. In the meantime, it's important—again, one piece that in this population is happening is, over a certain period of time, from a regulatory perspective, it will be important to show that even if patients advance or if they're worsening, we can address this population. So that will be something that the regulator will be looking at, and we will be happy to provide that information based on those approaches or inclusion criteria.

Christophe Arbet-Engels: So that will be something that the regulator will be looking at, and we will be happy to provide that information based on those approach or inclusion criteria.

Speaker #7: That's helpful. Thank you.

Jerome Durso: That is helpful. Thank you.

Christophe Arbet-Engels: Thanks.

Speaker #1: Thank you. And that's all the time we have for the Q&A session. I will now turn the call back over to Mr. Jerry Dersow for any closing comments.

Operator: Thank you. That is all the time we have for our Q&A session. I will now turn the call back over to Mr. Jerome Durso for any closing comments.

Speaker #7: Thanks, operator. And thanks, everybody, for joining us today. From our standpoint, we feel very positive about the progress we've made—significant progress. To date, I think we're clear.

Jerome Durso: Thanks, operator, and thanks everybody for joining us today. From our standpoint, we feel very positive about the progress we have made, significant progress to date. I think we are clear on the work to do ahead of us and definitely committed to continuing to advance what we believe to be a promising, meaningful, differentiated therapy in pemvidutide for serious liver conditions. Moving forward, it is going to be an exciting time. I will continue to update you on the progress moving forward, and enjoy the rest of the day, and have a great last of your summer. Take care.

Speaker #7: There is work to do ahead of us, and we are definitely committed to continuing to advance what we believe to be a promising, meaningful, differentiated therapy in PEMB for serious liver conditions.

Speaker #7: Moving forward, it's going to be an exciting time. I'll continue to update you on the progress moving forward, and enjoy the rest of the day.

Speaker #7: And have a great last year's summer. Take care.

Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.