Q4 2025 Veru Inc Earnings Call

Speaker #1: Good morning, ladies and

Operator: Good morning, ladies and gentlemen, and welcome to Veru Inc. Investors' Conference Call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After this morning's discussion, there will be an opportunity to ask questions. Please note that this event is being recorded. I would now like to turn the conference call over to Mr. Sam Fish, Veru Inc. Executive Director, Investor Relations and Corporate Communications. Please go ahead.

Speaker #1: Gentlemen, and welcome to VERU INC. Investors Conference Call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing zero.

Speaker #1: After this morning's star key followed by discussion, there will be an opportunity to ask questions. Please note this event is being recorded. I would now like to turn the conference call over to Mr. Stan Fish, VERU INC. Executive Director, Investor Relations and Corporate Communications.

Speaker #1: ahead.

Speaker #2: Statements made on this conference call may be

Sam Fish: The statements made on this conference call may be forward-looking statements. Forward-looking statements may include, but are not necessarily limited to, statements of the company's plans, objectives, expectations, or intentions regarding its business, operations, regulatory interactions, finances, and development of product portfolio. Such forward-looking statements are subject to known and unknown risks and uncertainties, and our actual results may differ significantly from those projected, suggested, or included in any forward-looking statements. Risks that may cause actual results or developments to differ materially are contained in our 10-Q and 10-K SEC filings, as well as in our press releases from time to time. I would now like to turn the conference call over to Dr. Mitchell Steiner, Veru Inc. Chairman, CEO, and President.

Sam Fisch: The statements made on this conference call may be forward-looking statements. Forward-looking statements may include, but are not necessarily limited to, statements of the company's plans, objectives, expectations, or intentions regarding its business, operations, regulatory interactions, finances, and development of product portfolio. Such forward-looking statements are subject to known and unknown risks and uncertainties, and our actual results may differ significantly from those projected, suggested, or included in any forward-looking statements.

Speaker #2: Forward-looking statements may include, but are not necessarily limited to, statements of the company's plans, objectives, expectations, or operations; regulatory interactions; and intentions regarding its business, finances, and development of product portfolio.

Speaker #2: Such forward-looking statements are subject to known and unknown risks and uncertainties, and actual results may differ significantly from those projected, suggested, or included in any forward-looking statements.

Risks that may cause actual results or developments to differ materially are contained in our 10-Q and 10-K SEC filings, as well as in our press releases from time to time. I would now like to turn the conference call over to Dr. Mitchell Steiner, Veru Inc. Chairman, CEO, and President.

Speaker #2: Risks that may cause actual results or developments to differ materially are contained in our 10-Q and 10-K SEC filings, as well as in our press releases from time to time.

Speaker #2: I would now like to turn the conference call over to Dr. Mitchell Steiner, VERU INC. Chairman and CEO. Also joining this morning's call are Dr. Gary Barnett, President.

Mitchell Steiner: Good morning. With me on this morning's call are Dr. Gary Barnett, Chief Scientific Officer, Michele Greco, Chief Financial Officer and Chief Administrative Officer, Philip Greenberg, General Counsel, and Sam Fish, Executive Director of Investor Relations and Corporate Communications. Thank you for joining our year-end fiscal year 2025 earnings call. Veru is a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of cardiometabolic and inflammatory diseases. Our drug development program consists of two new chemical entities, small molecules, enobosarm and sabizabulin. The first one is enobosarm, an oral selective androgen receptor modulator, or SARM. It's being developed as a next-generation drug that makes weight reduction by GLP-1 receptor agonist drugs more tissue-selective for fat loss with preservation of lean mass.

Mitchell Steiner: Good morning. With me on this morning's call are Dr. Gary Barnett, Chief Scientific Officer, Michele Greco, Chief Financial Officer and Chief Administrative Officer, Philip Greenberg, General Counsel, and Sam Fish, Executive Director of Investor Relations and Corporate Communications. Thank you for joining our year-end fiscal year 2025 earnings call. Veru is a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of cardiometabolic and inflammatory diseases. Our drug development program consists of two new chemical entities, small molecules, enobosarm and sabizabulin. The first one is enobosarm, an oral selective androgen receptor modulator, or SARM.

Speaker #2: Chief Scientific Officer, Michele. Good morning. With me on this are Greco, Chief Financial Officer and Chief Administrative Officer; Philip Greenberg, General Counsel; and Sam Fish, Corporate Communications.

Speaker #2: Thank you for joining Executive Director of Investor Relations and our year-end fiscal year 2025 earnings call. VERU is a late clinical-stage biopharmaceutical company focused on developing novel medicines for the treatment of cardiometabolic and inflammatory diseases.

Speaker #2: Our drug chemical entity small molecules development program consists of two new drugs: ANOVASARM and CIBIZABULIN. The first one is ANOVASARM, an oral selective androgen receptor modulator, or SARM.

It's being developed as a next-generation drug that makes weight reduction by GLP-1 receptor agonist drugs more tissue-selective for fat loss with preservation of lean mass. This activity is intended to lead to greater weight loss by improved body composition and physical function compared to a GLP-1 receptor agonist treatment alone, with a focus on older patients with obesity. Our second asset is sabizabulin, a microtubule disruptor, and it's being developed as a broad anti-inflammatory agent to reduce vascular plaque inflammation, to slow the progression and promote the regression of atherosclerotic cardiovascular disease.

Speaker #2: It's being developed as a next-generation drug that makes weight reduction by GLP-1 receptor agonist drugs more tissue-selective, enabling fat loss with preservation of lean mass.

Speaker #2: This activity is intended to lead to greater weight loss by improved body composition and physical function, compared to a GLP-1 receptor agonist treatment alone, with a focus on older patients with obesity.

Mitchell Steiner: This activity is intended to lead to greater weight loss by improved body composition and physical function compared to a GLP-1 receptor agonist treatment alone, with a focus on older patients with obesity. Our second asset is sabizabulin, a microtubule disruptor, and it's being developed as a broad anti-inflammatory agent to reduce vascular plaque inflammation, to slow the progression and promote the regression of atherosclerotic cardiovascular disease. This morning, we will focus on the update of our obesity program, and we'll also provide the financial highlights for our year-end fiscal year 2025. Now, let's set the stage with the recent FDA guidance on obesity drug development. The FDA defines obesity as a disease of excess body fat, and as such, the medical objectives to treat obesity should be to reduce excess body fat, not to reduce lean mass.

Speaker #2: Asset is CIBIZABULIN, our second microtubule disruptor, and it's being developed as a broad anti-inflammatory agent to reduce vascular plaque inflammation to slow the progression or promote regression of atherosclerotic cardiovascular disease.

This morning, we will focus on the update of our obesity program, and we'll also provide the financial highlights for our year-end fiscal year 2025. Now, let's set the stage with the recent FDA guidance on obesity drug development. The FDA defines obesity as a disease of excess body fat, and as such, the medical objectives to treat obesity should be to reduce excess body fat, not to reduce lean mass. Reduction of fat mass ultimately leads to improvements in morbidity and mortality associated with obesity. GLP-1 receptor agonists have been shown to reduce significant weight loss in patients who are overweight or have obesity.

Speaker #2: This morning, we will focus on the update of our obesity program, and we'll also provide the financial highlights for our year-end fiscal year 2025.

Speaker #2: Now, let's set the stage with the recent drug development. The FDA guidance on obesity defines obesity as a disease of excess body fat, and as such, the medical objective to treat obesity should be to reduce excess body fat, not to reduce lean mass.

Speaker #2: Reduction of fat mass ultimately leads to improvements in morbidity and mortality associated with obesity. GLP-1 receptor agonists have been shown to produce significant weight loss in patients who are overweight or have obesity.

Mitchell Steiner: Reduction of fat mass ultimately leads to improvements in morbidity and mortality associated with obesity. GLP-1 receptor agonists have been shown to reduce significant weight loss in patients who are overweight or have obesity. Unfortunately, the weight loss is tissue-non-selective, with the indiscriminate loss of both significant lean mass and fat. Of the total weight loss, up to 50% is attributable to lean mass. Although the GLP-1 receptor agonist treatment results in profound weight loss, the strategy for the next generation of obesity drugs should be a combination therapy with GLP-1 receptor agonists to only lose fat while preserving lean mass and physical function for equality weight reduction.

Unfortunately, the weight loss is tissue-non-selective, with the indiscriminate loss of both significant lean mass and fat. Of the total weight loss, up to 50% is attributable to lean mass. Although the GLP-1 receptor agonist treatment results in profound weight loss, the strategy for the next generation of obesity drugs should be a combination therapy with GLP-1 receptor agonists to only lose fat while preserving lean mass and physical function for equality weight reduction.

Speaker #2: Unfortunately, the weight loss is tissue non-selective, with the indiscriminate loss of both significant lean mass and fat. Of the total weight loss, up to 50% is attributable to lean mass.

Speaker #2: Although the GLP-1 receptor agonist treatment results in profound weight loss, the use of obesity drugs should be a strategy for the next generation combination therapy with a GLP-1 receptor agonist to only lose fat while preserving lean mass and physical function for quality weight reduction.

Speaker #2: Now, when we started our Phase 2B quality clinical trial evaluating ANOVASARM as a muscle-preserving drug in patients with obesity receiving a GLP-1 receptor agonist for weight reduction about two years ago, it was unknown at the time how any muscle anabolic drug would perform in this unique new patient population.

Mitchell Steiner: Now, when we started our Phase 2b QUALITY clinical trial evaluating enobosarm as a muscle-preserving drug in patients with obesity receiving a GLP-1 receptor agonist for weight reduction about two years ago, it was unknown at the time how any muscle anabolic drug would perform in this unique new patient population. The companies that were in Phase 2 testing stage were Lilly Versanis, Scholar Rock, and Regeneron with injectable agents in the myostatin inhibitors class, and VERU with an oral enobosarm from a different class called SARM. Fast forward to today, all these companies, including VERU, have reported their Phase 2 clinical results. In fact, VERU was the first company to report these clinical data in January 2025, and by September 2025, VERU also obtained FDA regulatory clarity to advance the clinical development of enobosarm in combination with GLP-1 receptor agonists as a muscle-preservation agent that augments fat loss.

Now, when we started our Phase 2b QUALITY clinical trial evaluating enobosarm as a muscle-preserving drug in patients with obesity receiving a GLP-1 receptor agonist for weight reduction about two years ago, it was unknown at the time how any muscle anabolic drug would perform in this unique new patient population. The companies that were in Phase 2 testing stage were Lilly Versanis, Scholar Rock, and Regeneron with injectable agents in the myostatin inhibitors class, and VERU with an oral enobosarm from a different class called SARM. Fast forward to today, all these companies, including VERU, have reported their Phase 2 clinical results.

Speaker #2: The companies that were in Phase 2 testing stage were Lilly, Versanis, Scholarock, and Regeneron, with injectable agents in the myostatin inhibitors class, and VERU with an oral ANOVASARM from a different class. As of today, all these companies, including VERU, have reported their Phase 2 clinical results.

In fact, VERU was the first company to report these clinical data in January 2025, and by September 2025, VERU also obtained FDA regulatory clarity to advance the clinical development of enobosarm in combination with GLP-1 receptor agonists as a muscle-preservation agent that augments fat loss.

Speaker #2: In fact, VERU was the first company to report these clinical data in January of 2025, and by September of SARM 2025, VERU also obtained FDA regulatory clarity to advance the clinical development of ANOVASARM in combination with a GLP-1 receptor agonist as a muscle-preservation agent in augmented fat loss.

Speaker #2: Our completed positive Phase 2B were critical, as they demonstrated oral ANOVASARM could be that next-generation drug in combination with a GLP-1 receptor agonist to make the weight loss journey more selective.

Mitchell Steiner: Our completed positive Phase 2b QUALITY clinical trial results were critical, as they demonstrated that oral enobosarm could be that next-generation drug in combination with GLP-1 receptor agonists to make the weight loss journey more selective by losing fat while preserving lean and physical function in older patients who have obesity with a positive safety profile. Now, turning to the results of the Phase 2b clinical trial, this time with a focus on the three-milligram enobosarm dose that has been selected for the next clinical trial. First, I will highlight the results for the 16-week active weight loss period of the treatment with enobosarm three milligrams or placebo in combination with semaglutide.

Our completed positive Phase 2b QUALITY clinical trial results were critical, as they demonstrated that oral enobosarm could be that next-generation drug in combination with GLP-1 receptor agonists to make the weight loss journey more selective by losing fat while preserving lean and physical function in older patients who have obesity with a positive safety profile. Now, turning to the results of the Phase 2b clinical trial, this time with a focus on the three-milligram enobosarm dose that has been selected for the next clinical trial. First, I will highlight the results for the 16-week active weight loss period of the treatment with enobosarm three milligrams or placebo in combination with semaglutide.

Speaker #2: By losing fat while preserving lean mass and physical function in older patients with obesity, and with a positive safety profile, we have quality clinical trial results. Now, turning to the results of the Phase 2B clinical trial—this time with a focus on the 3 milligram ANOVASARM dose that has been selective. First, I will highlight the results with the next clinical trial.

Speaker #2: Sixteen-week active weight loss, 3 milligrams or placebo, in combination with a period of treatment with ANOVASARM semaglutide. The ANOVASARM 3 milligram plus semaglutide group met the primary endpoint of the study: preservation of total lean mass, with a statistically significant 100% average preservation of total lean mass compared to the placebo plus semaglutide treatment group at 16 weeks.

Mitchell Steiner: The enobosarm 3 mg plus semaglutide group met the primary endpoint of the study: preservation of total lean mass with a statistically significant 100% average preservation of total lean mass compared to placebo plus semaglutide treatment group at 16 weeks. The enobosarm semaglutide treatment resulted in a dose-dependent greater loss of fat mass compared to placebo plus semaglutide, with the enobosarm 3-mg group having a 12% greater fat loss at 16 weeks. Even with having preserved lean mass, enobosarm 3 mg plus semaglutide treatment resulted in a similar mean body weight loss as semaglutide alone at 16 weeks. However, it should be noted, in a subset analysis of the subjects receiving enobosarm 3 mg who had a baseline BMI of greater than or equal to 35, incremental weight loss was observed at 16 weeks.

The enobosarm 3 mg plus semaglutide group met the primary endpoint of the study: preservation of total lean mass with a statistically significant 100% average preservation of total lean mass compared to placebo plus semaglutide treatment group at 16 weeks. The enobosarm semaglutide treatment resulted in a dose-dependent greater loss of fat mass compared to placebo plus semaglutide, with the enobosarm 3-mg group having a 12% greater fat loss at 16 weeks. Even with having preserved lean mass, enobosarm 3 mg plus semaglutide treatment resulted in a similar mean body weight loss as semaglutide alone at 16 weeks.

Speaker #2: The ANOVASARM semaglutide treatment resulted in a dose-dependent greater loss of fat mass compared to placebo plus semaglutide, with the ANOVASARM 3-milligram group having a 12% greater fat loss at 16 weeks.

Speaker #2: Even with having preserved lean mass, ANOVASARM 3 milligrams plus semaglutide treatment resulted in a similar mean body weight loss as semaglutide alone at 16 weeks.

However, it should be noted, in a subset analysis of the subjects receiving enobosarm 3 mg who had a baseline BMI of greater than or equal to 35, incremental weight loss was observed at 16 weeks. This was weight loss of 4.7% for semaglutide versus -5.58% for enobosarm three milligrams plus semaglutide treatment group. But when you look at the proportion of patients that lost at least 5% of their body weight at 16 weeks, it was 47.4% for semaglutide versus 65.4% for enobosarm three milligrams plus semaglutide treatment group. This weight loss occurred even with 84% preservation of lean mass in this subset of patients receiving semaglutide on enobosarm three milligrams.

Speaker #2: However, it should be noted, in a subset analysis of the subjects receiving ANOVASARM 3 milligrams who had a baseline BMI of greater than or equal to 35, incremental weight loss was observed at 16 weeks.

Mitchell Steiner: This was weight loss of 4.7% for semaglutide versus -5.58% for enobosarm three milligrams plus semaglutide treatment group. But when you look at the proportion of patients that lost at least 5% of their body weight at 16 weeks, it was 47.4% for semaglutide versus 65.4% for enobosarm three milligrams plus semaglutide treatment group. This weight loss occurred even with 84% preservation of lean mass in this subset of patients receiving semaglutide on enobosarm three milligrams. Now, the tissue composition of the total body weight loss on average was 34% lean mass and 66% fat mass in the placebo semaglutide group, whereas for enobosarm three milligrams and semaglutide group, the weight loss was 0% lean and 100% fat mass. Now, we measured physical function by the stair-climb test.

Speaker #2: Weight loss was 4.7% for semaglutide, versus minus 5.58% for ANOVASARM 3 milligrams. Plus, the proportion of patients that lost at least 5% of their body weight at 16 weeks—it was the semaglutide treatment group.

Speaker #2: Weight loss was 4.7% for semaglutide, versus minus 5.58% for ANOVASARM 3 milligrams plus. For the proportion of patients that lost at least 5% of their body weight at 16 weeks, it was 47.4% for the semaglutide treatment group, versus 65.4% for the ANOVASARM 3 milligrams plus semaglutide treatment group.

Speaker #2: This occurred even with 84% preservation of lean mass in this subset of patients receiving semaglutide on ANOVASARM 3 milligrams. Now, when you look at the composition of the total body weight loss, on average it was 34% lean mass and 66% fat mass in the placebo/semaglutide group. Whereas for the ANOVASARM 3 milligrams and semaglutide group, the weight loss was 0% lean and 100% fat mass.

Now, the tissue composition of the total body weight loss on average was 34% lean mass and 66% fat mass in the placebo semaglutide group, whereas for enobosarm three milligrams and semaglutide group, the weight loss was 0% lean and 100% fat mass. Now, we measured physical function by the stair-climb test. This was a pre-specified responder analysis, and this was conducted using greater than 10% decline in stair-climb power as a cutoff at 16 weeks, which is a decline that represents approximately seven to eight years of loss of stair-climb power that naturally occurs with aging, but it occurred in this case in 16 weeks.

Speaker #2: Now, we measured physical function by the serocline test. This was a pre-specified responder analysis, and this was conducted using greater than 10% decline in serocline power as a cutoff at 16 weeks, which is a decline that represents approximately 7 to 8 years of loss of serocline power that naturally occurs with aging, but it occurred in this case in 16 weeks.

Mitchell Steiner: This was a pre-specified responder analysis, and this was conducted using greater than 10% decline in stair-climb power as a cutoff at 16 weeks, which is a decline that represents approximately seven to eight years of loss of stair-climb power that naturally occurs with aging, but it occurred in this case in 16 weeks. Semaglutide alone resulted in the loss of physical function, as much as 44.8% of the placebo plus semaglutide group had at least a 10% decline in stair-climb power at 16 weeks. The Phase 2b QUALITY studies first to confirm that older patients with obesity receiving a GLP-1 receptor agonist indeed had a significant and relevant physical function decline and picked up as early as 16 weeks on treatment. In contrast, enobosarm 3-milligram treatment reduced the proportion of patients receiving semaglutide to 17.6% who experienced a greater than 10% decline in stair-climb power.

Semaglutide alone resulted in the loss of physical function, as much as 44.8% of the placebo plus semaglutide group had at least a 10% decline in stair-climb power at 16 weeks. The Phase 2b QUALITY studies first to confirm that older patients with obesity receiving a GLP-1 receptor agonist indeed had a significant and relevant physical function decline and picked up as early as 16 weeks on treatment. In contrast, enobosarm 3-milligram treatment reduced the proportion of patients receiving semaglutide to 17.6% who experienced a greater than 10% decline in stair-climb power.

Speaker #2: Semaglutide alone resulted in the loss of physical function, as much as 44.8% of the placebo plus semaglutide group had at least a 10% decline in serocline power.

Speaker #2: At 16 weeks, the Phase 2B quality studies first confirm that older patients with obesity receiving a GLP-1 receptor agonist indeed had a significant and relevant physical function decline, and this was picked up as early as 16 weeks on treatment.

Speaker #2: In contrast, ANOVASARM 3 milligram treatment reduced the proportion of patients receiving semaglutide to 17.6% who experienced a greater than 10% decline in serocline power. This represents a 59.8% relative reduction in the proportion of patients receiving ANOVASARM who experienced a greater than or equal to 10% decline in serocline power.

Mitchell Steiner: This represents a 59.8% relative reduction in the proportion of patients receiving enobosarm who experienced a greater than or equal 10% decline in stair-climb power. Now, for the maintenance extension portion of the study, where all patients discontinued semaglutide treatment but continued receiving placebo enobosarm 3 milligrams as monotherapy for 12 weeks, the results were, for the placebo monotherapy group, they actually regained 43% of their body weight that was previously lost during the active weight loss period of the Phase 2b QUALITY study, but mean percentage change of 2.57%, basically 5 pounds, they gained back in body weight compared to 1.41% or 2.73 pounds for the 3-milligram enobosarm group. This means that the 3-milligram enobosarm monotherapy significantly reduced body weight regain by 46% after discontinuing the semaglutide.

This represents a 59.8% relative reduction in the proportion of patients receiving enobosarm who experienced a greater than or equal 10% decline in stair-climb power. Now, for the maintenance extension portion of the study, where all patients discontinued semaglutide treatment but continued receiving placebo enobosarm 3 milligrams as monotherapy for 12 weeks, the results were, for the placebo monotherapy group, they actually regained 43% of their body weight that was previously lost during the active weight loss period of the Phase 2b QUALITY study, but mean percentage change of 2.57%, basically 5 pounds, they gained back in body weight compared to 1.41% or 2.73 pounds for the 3-milligram enobosarm group.

Speaker #2: Now, for the maintenance extension portion of the study, where all patients discontinued semaglutide treatment but continued receiving placebo ANOVASARM 3 milligrams as monotherapy for 12 weeks, the results were for the placebo monotherapy group, they actually regained 43% of their body weight that was loss period of the Phase 2B quality study for mean percentage change of 2.57%, basically 5 pounds, they gained previously lost during the active weight back in body weight compared to 1.41% or 2.73 pounds for the 3 milligram ANOVASARM group.

This means that the 3-milligram enobosarm monotherapy significantly reduced body weight regain by 46% after discontinuing the semaglutide. But by the way, the mean tissue composition of the body weight that was actually regained was 100% lean mass, not fat, for the enobosarm 3-milligram group compared to 28% fat and 72% lean mass in the placebo group. In fact, by the end of the 28-week study, the enobosarm 3-milligram plus semaglutide arm followed by the enobosarm 3-milligram monotherapy regimen was more effective in preserving 100% lean mass and losing 58% more fat compared to the group receiving placebo plus semaglutide followed by placebo monotherapy alone.

Speaker #2: This means that the 3 milligram ANOVASARM monotherapy significantly reduced body weight regain by 46% after discontinuing the semaglutide. By the way, the mean tissue composition of the body weight that was actually regained was 100% lean mass, not fat, for the ANOVASARM 3 milligram group, compared to 28% fat and 72% lean mass in the placebo group.

Mitchell Steiner: But by the way, the mean tissue composition of the body weight that was actually regained was 100% lean mass, not fat, for the enobosarm 3-milligram group compared to 28% fat and 72% lean mass in the placebo group. In fact, by the end of the 28-week study, the enobosarm 3-milligram plus semaglutide arm followed by the enobosarm 3-milligram monotherapy regimen was more effective in preserving 100% lean mass and losing 58% more fat compared to the group receiving placebo plus semaglutide followed by placebo monotherapy alone. As for safety, at the end of the 16-week active weight loss period, enobosarm and semaglutide combination had a positive safety profile, and enobosarm did not have any added gastrointestinal adverse events compared to semaglutide alone. For the maintenance extension period of the clinical trial, when semaglutide was stopped for 12 weeks, enobosarm monotherapy also had a positive safety profile.

Speaker #2: In fact, by the end of the 28-week study, the ANOVASARM 3-milligram plus semaglutide arm, followed by the ANOVASARM 3-milligram monotherapy regimen, was more effective in preserving 100% lean mass and losing 58% more fat compared to the group receiving placebo plus semaglutide, followed by placebo monotherapy alone.

As for safety, at the end of the 16-week active weight loss period, enobosarm and semaglutide combination had a positive safety profile, and enobosarm did not have any added gastrointestinal adverse events compared to semaglutide alone. For the maintenance extension period of the clinical trial, when semaglutide was stopped for 12 weeks, enobosarm monotherapy also had a positive safety profile. And after discontinuation of semaglutide, there were essentially no gastrointestinal side effects. No evidence of drug-induced liver injury, no increases in obstructive sleep apnea were observed at any dose of enobosarm compared to placebo monotherapy.

Speaker #2: As for safety, at the end of the 16-week active weight loss period, ANOVASARM and semaglutide combination had a positive safety profile, and ANOVASARM did not have any added gastrointestinal adverse events compared to semaglutide alone.

Speaker #2: During the period of the clinical trial, semaglutide was stopped for 12 weeks, and ANOVASARM monotherapy also had a positive safety profile. For the maintenance extension, and after discontinuing semaglutide, there were essentially no gastrointestinal side effects, no evidence of drug-induced liver injury, and no increases in obstructive sleep apnea were observed at any dose of ANOVASARM compared to placebo monotherapy.

Mitchell Steiner: And after discontinuation of semaglutide, there were essentially no gastrointestinal side effects. No evidence of drug-induced liver injury, no increases in obstructive sleep apnea were observed at any dose of enobosarm compared to placebo monotherapy. There were no adverse events related to masculinization in women, and there were no adverse events related to increases in prostate-specific antigen, which is PSA, in men. So, in summary, the Phase 2b QUALITY clinical trial confirms that by preserving lean mass and physical function with enobosarm plus semaglutide led to greater fat loss during the active weight loss period, and after semaglutide was discontinued, enobosarm monotherapy significantly prevented the regain of body weight and fat mass, such that by the end of the 28-week study, there was greater loss of fat mass while preserving lean mass for higher quality weight reduction compared to the placebo group.

There were no adverse events related to masculinization in women, and there were no adverse events related to increases in prostate-specific antigen, which is PSA, in men. So, in summary, the Phase 2b QUALITY clinical trial confirms that by preserving lean mass and physical function with enobosarm plus semaglutide led to greater fat loss during the active weight loss period, and after semaglutide was discontinued, enobosarm monotherapy significantly prevented the regain of body weight and fat mass, such that by the end of the 28-week study, there was greater loss of fat mass while preserving lean mass for higher quality weight reduction compared to the placebo group.

Speaker #2: There were no adverse events related to masculinization in women, and there was no adverse event related to increases in prostate-specific antigen in men. 2B quality clinical trial. So, in summary, the Phase confirms that by preserving lean—which is PSA in mass and physical function—with ANOVASARM plus semaglutide, it led to greater period, and after semaglutide was discontinued, ANOVASARM fat loss during the active weight loss monotherapy significantly prevented the regain of body weight and fat mass. Such that, by the end of the 28-week study, there was greater loss of fat mass while preserving lean mass for a higher quality weight reduction compared to the placebo group.

Speaker #2: Next, I will update you on the ANOVASARM clinical development plan. Because this field is very new, the regulatory landscape continues to evolve for muscle preservation drugs for the treatment of obesity.

Mitchell Steiner: Next, I will update you on the Enobosarm clinical development plan. Because this field is very new, the regulatory landscape continues to evolve for muscle-preservation drugs for the treatment of obesity. According to the FDA feedback on Veru's clinical development program for Enobosarm, FDA has guided us that there are at least two possible regulatory pathways forward for the development of Enobosarm in combination with GLP-1 receptor agonists that are based on incremental weight loss. First, incremental weight loss with at least a 5% placebo-corrected weight loss difference at 52 weeks of maintenance treatment with Enobosarm in combination with GLP-1 receptor agonist treatment compared to GLP-1 receptor treatment alone is an acceptable primary endpoint to support efficacy for approval.

Next, I will update you on the Enobosarm clinical development plan. Because this field is very new, the regulatory landscape continues to evolve for muscle-preservation drugs for the treatment of obesity. According to the FDA feedback on Veru's clinical development program for Enobosarm, FDA has guided us that there are at least two possible regulatory pathways forward for the development of Enobosarm in combination with GLP-1 receptor agonists that are based on incremental weight loss.

Speaker #2: According to the FDA feedback, there are at least two possible regulatory pathways forward for the development of ANOVASARM in combination with a GLP-1 receptor agonist that are based on incremental weight loss as part of VERU's clinical development program. The FDA has guided us on these options.

First, incremental weight loss with at least a 5% placebo-corrected weight loss difference at 52 weeks of maintenance treatment with Enobosarm in combination with GLP-1 receptor agonist treatment compared to GLP-1 receptor treatment alone is an acceptable primary endpoint to support efficacy for approval. Second, and alternatively, if the incremental weight loss difference of less than 5% is less than 5%, including similar weight loss is observed at 52 weeks of maintenance treatment, but you have a clinically significant positive benefit, such as a clinically beneficial preservation of physical function, enobosarm in combination with a GLP-1 receptor agonist may also be acceptable to support efficacy for approval.

Speaker #2: First, incremental weight loss with at least a 5% placebo-corrected weight loss difference after 52 weeks of maintenance treatment with ANOVASARM in combination with GLP-1 receptor agonist treatment, compared to GLP-1 receptor treatment alone, is an acceptable primary endpoint to support efficacy for approval.

Mitchell Steiner: Second, and alternatively, if the incremental weight loss difference of less than 5% is less than 5%, including similar weight loss is observed at 52 weeks of maintenance treatment, but you have a clinically significant positive benefit, such as a clinically beneficial preservation of physical function, enobosarm in combination with a GLP-1 receptor agonist may also be acceptable to support efficacy for approval. Accordingly, with this feedback from the FDA and building on the clinical data from the Phase 2b QUALITY study, what would be the best patient population with obesity to target with a combination of enobosarm and a GLP-1 receptor agonist? An emerging common and serious clinical and therapeutic challenge with GLP-1 receptor agonist monotherapy is that most patients with obesity, by the end of one year of GLP-1 receptor agonist maintenance treatment, hit a weight loss plateau.

Speaker #2: Incremental weight loss difference of less than 5%, including similar weight loss—if 5% is less than observed at 52 weeks of maintenance—second, treatment, but you have a clinically significant positive benefit such as a clinically beneficial function. ANOVASARM, in combination with a preservation in physical GLP-1 receptor agonist, may also be acceptable to support efficacy for approval.

Accordingly, with this feedback from the FDA and building on the clinical data from the Phase 2b QUALITY study, what would be the best patient population with obesity to target with a combination of enobosarm and a GLP-1 receptor agonist? An emerging common and serious clinical and therapeutic challenge with GLP-1 receptor agonist monotherapy is that most patients with obesity, by the end of one year of GLP-1 receptor agonist maintenance treatment, hit a weight loss plateau.

Speaker #2: Accordingly, with this feedback from the FDA, and building on the clinical data from the Phase 2b clinical quality study, what would be the best patient population with obesity to target with a combination of ANOVASARM and agonist?

Speaker #2: An emerging common and serious clinical and therapeutic a GLP-1 receptor challenge with GLP-1 receptor agonist monotherapy is that most patients with obesity by the end of one year of GLP-1 receptor agonist maintenance occurs when the patient with obesity stops losing additional weight while plateau.

Speaker #2: The weight loss plateau

Mitchell Steiner: The weight loss plateau occurs when the patient with obesity stops losing additional weight while on a GLP-1 receptor agonist. In the SURMOUNT-1 clinical study conducted by Eli Lilly and Company, about 88% of patients with obesity receiving tirzepatide reached a weight loss plateau by 60 to 72 weeks. Unfortunately, 62.6% of these patients still had clinical obesity at the time they reached the weight loss plateau. Further, if they start the GLP-1 treatment with a baseline BMI of greater or equal to 35, then these patients were on average still found to have clinical obesity at the time they hit the weight loss plateau. Interestingly, one of the therapeutic interventions being considered for this patient population is bariatric surgery to address the GLP-1 receptor weight loss plateau.

The weight loss plateau occurs when the patient with obesity stops losing additional weight while on a GLP-1 receptor agonist. In the SURMOUNT-1 clinical study conducted by Eli Lilly and Company, about 88% of patients with obesity receiving tirzepatide reached a weight loss plateau by 60 to 72 weeks. Unfortunately, 62.6% of these patients still had clinical obesity at the time they reached the weight loss plateau. Further, if they start the GLP-1 treatment with a baseline BMI of greater or equal to 35, then these patients were on average still found to have clinical obesity at the time they hit the weight loss plateau.

Speaker #1: By and company Lilly Eli. But 88% of patients with obesity receiving tirzepatide reach the weight loss plateau by, still had unfortunately, the time 62.6% of these the weight clinical 60 to 72 weeks.

Speaker #1: obesity at Further . , if they start GLP the one treatment with a baseline of BMI greater or equal than 35 , then these patients would on average still found to have clinical obesity .

Speaker #1: At the time of loss of weight, interestingly, one of the plateau therapeutic interventions being considered for this patient population is bariatric surgery.

Interestingly, one of the therapeutic interventions being considered for this patient population is bariatric surgery to address the GLP-1 receptor weight loss plateau. To address this growing weight loss plateau population, a novel combination of a GLP-1 receptor agonist, which works by telling the brain to reduce appetite, combined with enobosarm, which is designed to directly burn fat and to directly preserve muscle to increase physical function and burn more calories, could break through this weight loss plateau, leading to incremental weight reduction, thereby increasing the number of patients with obesity who actually achieve and maintain a normal BMI and weight. Our next study will target this patient population.

Speaker #1: address a GLP one receptor weight To plateau loss . To address this growing weight population , a novel loss combination of GLP agonist by telling the brain , which works reduce one receptor to plateau , combined with directly arm which to an appetite directly preserve to physical function and increase burn more calories , could break through loss plateau , this weight leading to incremental muscle to weight reduction .

Mitchell Steiner: To address this growing weight loss plateau population, a novel combination of a GLP-1 receptor agonist, which works by telling the brain to reduce appetite, combined with enobosarm, which is designed to directly burn fat and to directly preserve muscle to increase physical function and burn more calories, could break through this weight loss plateau, leading to incremental weight reduction, thereby increasing the number of patients with obesity who actually achieve and maintain a normal BMI and weight. Our next study will target this patient population.

Speaker #1: Thereby increasing the number of patients with obesity who actually achieve and maintain a normal BMI, and to measure weight loss with this population.

Speaker #1: BMI have more will trial loss in plan than incremental weight in patient target 35, and for this, risk decline and more at age greater than or limitations. The 65.

Mitchell Steiner: The planned Phase 2b PLATEAU clinical trial will measure incremental weight loss in this target population who have more weight to lose with a BMI greater than 35 and more at risk for physical decline and physical limitations, age greater than or equal to 65, to assess the ability of enobosarm treatment to break through the weight loss plateau and help us also to better inform the design of the Phase 3 development program. Now, for the planned Phase 2b PLATEAU clinical trial, we will evaluate the effect of enobosarm 3 milligrams on total body weight, physical function, and safety in approximately 200 patients who have obesity, a BMI greater than or equal to 35, and who are older, age greater than or equal to 65, and are initiating a GLP-1 receptor treatment for weight reduction.

The planned Phase 2b PLATEAU clinical trial will measure incremental weight loss in this target population who have more weight to lose with a BMI greater than 35 and more at risk for physical decline and physical limitations, age greater than or equal to 65, to assess the ability of enobosarm treatment to break through the weight loss plateau and help us also to better inform the design of the Phase 3 development program.

Speaker #1: To clinically assess the ability of the study to break out the Novus arm and help target to inform the better design of the next phase three development program for the planned phase two Plateau clinical trial, we will evaluate the effect of Enobosarm, three milligrams, on total body physical function and weight, and safety, in 200 patients who have a BMI of approximately 35 or greater, who are older, and who have obesity—that is, a BMI greater than 30—and who are initiating a treatment for weight reduction with GLP.

Now, for the planned Phase 2b PLATEAU clinical trial, we will evaluate the effect of enobosarm 3 milligrams on total body weight, physical function, and safety in approximately 200 patients who have obesity, a BMI greater than or equal to 35, and who are older, age greater than or equal to 65, and are initiating a GLP-1 receptor treatment for weight reduction. The primary efficacy endpoint of the study will be the percent change from baseline total body weight at 72 weeks. An interim analysis will be conducted at 36 weeks to assess the percent change from baseline lean body mass and fat mass as measured by DEXA scan.

Speaker #1: The primary efficacy endpoint of the study will be the percent one receptor change from greater or body weight in total at 72 weeks, at baseline.

Mitchell Steiner: The primary efficacy endpoint of the study will be the percent change from baseline total body weight at 72 weeks. An interim analysis will be conducted at 36 weeks to assess the percent change from baseline lean body mass and fat mass as measured by DEXA scan. Since we want to continue to evaluate enobosarm as a muscle-preservation and body composition drug, the key secondary endpoints will be function endpoints: physical function stair-climb tests, mobility, disability status, which is functional limitations, and patient-reported outcome questionnaires for physical function, such as the SF-36, PF-10, and the IWQOL-Lite-CT physical function PROs, as well as body composition endpoints: total fat mass, total lean mass, and bone mineral density. As for our financial position to fund the Phase 2b program, as of 30 September 2025, our cash and cash equivalents and restricted cash balance was $15.8 million.

Speaker #1: At 36 weeks, we will assess the percent change from baseline in lean body mass and fat mass, as measured by DEXA scan. Since we want to evaluate if Enobosarm is a muscle preservation and body composition drug, key secondary endpoints will be function endpoints.

Since we want to continue to evaluate enobosarm as a muscle-preservation and body composition drug, the key secondary endpoints will be function endpoints: physical function stair-climb tests, mobility, disability status, which is functional limitations, and patient-reported outcome questionnaires for physical function, such as the SF-36, PF-10, and the IWQOL-Lite-CT physical function PROs, as well as body composition endpoints: total fat mass, total lean mass, and bone mineral density. As for our financial position to fund the Phase 2b program, as of 30 September 2025, our cash and cash equivalents and restricted cash balance was $15.8 million.

Speaker #1: Physical function climb test , stair disability status , , mobility , functional limitations , and patient which is reported outcome questionnaires . The physical function , such as the SF 36 , PF ten and AIS QoL the Lite CT physical function .

Speaker #1: Pros . As well as body endpoints , composition mass , mass bone total fat mineral total lean density and . As for our financial position to fund the phase as of September 30th , two program , our 2025 , cash and equivalents and cash restricted cash balance was $15.8 million , and September 30th , subsequent to October 31st , 2025 .

Speaker #1: In 2025, we completed a public offering that resulted in net proceeds to the company of approximately $23.4 million. The clinical program is expected to continue as planned.

Mitchell Steiner: Subsequent to 30 September 2025, on 31 October 2025, we completed a public offering that resulted in net proceeds to the company of approximately $23.4 million. The clinical study is expected to begin in Q1 2026. An interim analysis to assess change in lean mass and fat mass, as measured by DEXA, will be conducted at 36 weeks and is anticipated to be in Q1 2027. I will now turn the call over to Michele Greco, CFO, CAO, to discuss the financial highlights. Michele? Thank you, Dr. Steiner. On 30 December 2024, VERU sold the FC2 female condom business to Clear Future, Inc. The purchase price was $18 million in cash, subject to adjustment as set forth in the purchase agreement for the transaction.

Subsequent to 30 September 2025, on 31 October 2025, we completed a public offering that resulted in net proceeds to the company of approximately $23.4 million. The clinical study is expected to begin in Q1 2026. An interim analysis to assess change in lean mass and fat mass, as measured by DEXA, will be conducted at 36 weeks and is anticipated to be in Q1 2027. I will now turn the call over to Michele Greco, CFO, CAO, to discuss the financial highlights. Michele?

Speaker #1: Calendar year 2026. An interim first quarter of analysis to assess change in lean mass and fat by measured DEXA will be conducted at 36 weeks and anticipated to mass, as be in first quarter of calendar year 2027.

Speaker #1: I will now turn the call over to our CFO, Michele Greco, to discuss the financial highlights. Michele.

Speaker #2: , Doctor Steiner . On December 30th , Thank you 2024 , Viru sold the Fc2 condom business female to Clear Inc. The Future , purchase price was $18 million in cash , subject to adjustment as forth in the purchase agreement for the transaction set .

Michele Greco: Thank you, Dr. Steiner. On 30 December 2024, VERU sold the FC2 female condom business to Clear Future, Inc. The purchase price was $18 million in cash, subject to adjustment as set forth in the purchase agreement for the transaction. Net proceeds from the sale of the FC2 female condom business were approximately $16.5 million after selling costs and other purchase price adjustments, but before a change of control payment of $4.2 million owed to SWK Holdings, pursuant to a residual royalty agreement for a 2018 financing transaction.

Speaker #2: proceeds from the sale of the Net condom Fc2 business were female approximately $16.5 million . After selling price adjustments . But purchase before other a change payment costs and of $4.2 million owed to Swk Holdings pursuant to a residual control , agreement for a 2018 financing transaction .

Mitchell Steiner: Net proceeds from the sale of the FC2 female condom business were approximately $16.5 million after selling costs and other purchase price adjustments, but before a change of control payment of $4.2 million owed to SWK Holdings, pursuant to a residual royalty agreement for a 2018 financing transaction. The loss on the sale of the FC2 female condom business was approximately $4.1 million, the difference between the estimated net proceeds of $16.5 million and the total carrying value of the FC2 business of $20.6 million. On 30 December 2024, the carrying value of the FC2 female condom business was comprised primarily of deferred income tax assets of $12.3 million, accounts receivable of $4.6 million, and inventory of $3.4 million, partially offset by accrued expenses and other current liabilities of $1.5 million. Liabilities associated with the residual royalty agreement, which totaled $9.9 million at 30 September 2024, were extinguished.

Speaker #2: The loss on the sale of the female condom business was Fc2 approximately $4.1 million . difference between the net The estimated proceeds of $16.5 million and the total of the carrying Fc2 value business of $20.6 million on December 30th , 2020 , for .

The loss on the sale of the FC2 female condom business was approximately $4.1 million, the difference between the estimated net proceeds of $16.5 million and the total carrying value of the FC2 business of $20.6 million. On 30 December 2024, the carrying value of the FC2 female condom business was comprised primarily of deferred income tax assets of $12.3 million, accounts receivable of $4.6 million, and inventory of $3.4 million, partially offset by accrued expenses and other current liabilities of $1.5 million. Liabilities associated with the residual royalty agreement, which totaled $9.9 million at 30 September 2024, were extinguished.

Speaker #2: The carrying value of the FC2 female condom business was primarily comprised of deferred income tax of $12.3 million, accounts receivable assets of $4.6 million, and inventory of $3.4 million.

Speaker #2: and partially offset by accrued expenses and other current liabilities of $1.5 million. Liabilities associated with the residual royalty agreement, which totaled $9.9 million at September 30, 2024, were from the sale of the FC2 Female.

Speaker #2: change , allowing the to strategy focus all extinguished its efforts in drug exclusively on The development and also affects how present our operations and financial results in our financial revenues , we and expenses costs related to the direct Fc2 condom female business .

Mitchell Steiner: The sale of the FC2 Female Condom business represented a change in strategy, allowing the company to focus all its efforts exclusively on drug development and also affects how we present our operations and financial results. In our financial statements, all direct revenues, costs, and expenses related to the FC2 Female Condom business are classified within loss from discontinued operations, net of tax, in the statement of operations.

The sale of the FC2 Female Condom business represented a change in strategy, allowing the company to focus all its efforts exclusively on drug development and also affects how we present our operations and financial results. In our financial statements, all direct revenues, costs, and expenses related to the FC2 Female Condom business are classified within loss from discontinued operations, net of tax, in the statement of operations.

Speaker #2: statements . classified within loss Are discontinued operations , net of tax in the All statement of Operations on October 31st , 2025 , completed an public underwritten offering of company 1.4 million shares of our the stock common pre-funded warrants to to 7 million shares of our common stock .

Speaker #2: statements . classified within loss Are discontinued operations , net of tax in the All statement of Operations on October 31st , 2025 , completed an public underwritten offering of company 1.4 million shares of our the stock common pre-funded warrants to to 7 million shares of our common stock purchase up up to common stock , accompanying series B warrants to purchase up 8.4 million shares of 8.4 million shares of our our common to stock at a public offering price of $3 per common share of and the stock accompanying series A and B warrants net proceeds to the company .

Mitchell Steiner: On 31 October 2025, the company completed an underwritten public offering of 1.4 million shares of our common stock, pre-funded warrants to purchase up to 7 million shares of our common stock, accompanying Series A warrants to purchase up to 8.4 million shares of our common stock, and accompanying Series B warrants to purchase up to 8.4 million shares of our common stock, at a public offering price of $3 per common share of stock and the accompanying Series A and B warrants. Net proceeds to the company from this offering were approximately $23.4 million after deducting underwriting discounts and commissions and costs paid by the company. Now, let's review the results for the fiscal year ended 30 September 2025. Research and development costs increased to $15.6 million in fiscal 2025 from $12.8 million in the prior year.

On 31 October 2025, the company completed an underwritten public offering of 1.4 million shares of our common stock, pre-funded warrants to purchase up to 7 million shares of our common stock, accompanying Series A warrants to purchase up to 8.4 million shares of our common stock, and accompanying Series B warrants to purchase up to 8.4 million shares of our common stock, at a public offering price of $3 per common share of stock and the accompanying Series A and B warrants. Net proceeds to the company from this offering were approximately $23.4 million after deducting underwriting discounts and commissions and costs paid by the company.

Speaker #2: From offering this approximately were $23.4 million . After deducting underwriting discounts commissions costs paid by the company and . Now , let's review and the results for the fiscal year September 30th , ended 2025 .

Now, let's review the results for the fiscal year ended 30 September 2025. Research and development costs increased to $15.6 million in fiscal 2025 from $12.8 million in the prior year. The increase is due to an increase in expenses incurred related to the company's Phase 2b QUALITY clinical study for enobosarm as a treatment to augment fat loss and to prevent muscle loss, partially offset by a decrease in expenditures related to the company's other drug development programs that were terminated in previous years, and a decrease in personnel costs. Selling, general, and administrative expenses were $19.9 million in fiscal 2025, compared to $24.6 million in the prior year.

Speaker #2: Research and development costs increased to $15.6 million in fiscal 2025, from $12.8 million in the prior year. The increase is due to an increase in expenses incurred related to the quality clinical study for Novasome as a treatment to augment fat loss and prevent muscle, offset by a company's phase two.

Mitchell Steiner: The increase is due to an increase in expenses incurred related to the company's Phase 2b QUALITY clinical study for enobosarm as a treatment to augment fat loss and to prevent muscle loss, partially offset by a decrease in expenditures related to the company's other drug development programs that were terminated in previous years, and a decrease in personnel costs. Selling, general, and administrative expenses were $19.9 million in fiscal 2025, compared to $24.6 million in the prior year. The decrease is primarily due to a decrease in the expense related to share-based compensation. We recognize the gain on sale of Entadfi assets of $10.8 million in fiscal 2025, compared to a gain of $1.2 million in the prior year, which is based on non-refundable consideration received related to promissory notes due to Veru.

Speaker #2: expenditures related to the company's other drug development loss , programs that were terminated in previous years and a decrease in personnel . Selling costs , general and administrative were $19.9 million in fiscal 2025 , expenses compared to $24.6 million in the prior year .

Speaker #2: decrease is due to a decrease in the expense related to share based The . We recognized a gain on sale of Entadfi assets of in fiscal 2025 , compared to a gain B of $1.2 million in the prior $10.8 million year , which is based on non-refundable consideration received related to promissory Due to Viru notes .

The decrease is primarily due to a decrease in the expense related to share-based compensation. We recognize the gain on sale of Entadfi assets of $10.8 million in fiscal 2025, compared to a gain of $1.2 million in the prior year, which is based on non-refundable consideration received related to promissory notes due to Veru. During the year, the company entered into a settlement agreement with Onconetix, whereby the company received a cash payment of $6.3 million and Series D preferred stock in a warrant, which had a combined fair value of $2.5 million.

Speaker #2: During the year , the . company entered into a settlement agreement with an Connetics , whereby the company received a cash payment of $6.3 million in series B stock and a warrant which had a combined fair value preferred of $2.5 million .

Mitchell Steiner: During the year, the company entered into a settlement agreement with Onconetix, whereby the company received a cash payment of $6.3 million and Series D preferred stock in a warrant, which had a combined fair value of $2.5 million. In conjunction with the sale of the FC2 female condom business, we recorded a gain on extinguishment of debt of $8.6 million related to the termination of the residual royalty agreement. This represents the difference between the change of control payment of $4.2 million and the net carrying amount of the extinguished debt of $12.8 million, which included an embedded derivative for the change of control provision at fair value of $4.7 million. The loss associated with the change in fair value of equity securities in fiscal 2025 was $0.3 million, compared with $0.2 million for fiscal 2024.

Speaker #2: In conjunction with the sale of the FC2 Female Condom business, we recorded a gain on extinguishment of debt of $8.6 million related to the termination of the residual royalty agreement. This represents the difference.

In conjunction with the sale of the FC2 female condom business, we recorded a gain on extinguishment of debt of $8.6 million related to the termination of the residual royalty agreement. This represents the difference between the change of control payment of $4.2 million and the net carrying amount of the extinguished debt of $12.8 million, which included an embedded derivative for the change of control provision at fair value of $4.7 million. The loss associated with the change in fair value of equity securities in fiscal 2025 was $0.3 million, compared with $0.2 million for fiscal 2024.

Speaker #2: Between the change of control payment of $4.2 million and the net carrying amount of the extinguished debt of $12.8 million, which included an embedded derivative for the change of control provision valued at fair value of $4.7 million.

Speaker #2: The loss associated with the change in fair value of equity securities in fiscal 2025 was compared with $0.3 million and $0.2 million for fiscal 2024.

Speaker #2: This is due primarily to the change in the fair value of shares of common stock we previously held, which were during fiscal 2025.

Mitchell Steiner: This is due primarily to the change in the fair value of the shares of Onconetix's common stock we previously held, which were sold during fiscal 2025. The bottom line result from continuing operations for the fiscal year was a net loss of $15.7 million, or $1.07 per diluted common share, compared to a net loss of $35.3 million, or $2.61 per diluted common share in the prior year. For fiscal 2025, net loss from discontinued operations, net of taxes, related to the FC2 business was $7 million, or $0.48 per diluted common share, including the $4.1 million loss on the sale of the FC2 business, compared to a net loss of $2.5 million, or $0.19 per diluted common share in the prior period.

This is due primarily to the change in the fair value of the shares of Onconetix's common stock we previously held, which were sold during fiscal 2025. The bottom line result from continuing operations for the fiscal year was a net loss of $15.7 million, or $1.07 per diluted common share, compared to a net loss of $35.3 million, or $2.61 per diluted common share in the prior year. For fiscal 2025, net loss from discontinued operations, net of taxes, related to the FC2 business was $7 million, or $0.48 per diluted common share, including the $4.1 million loss on the sale of the FC2 business, compared to a net loss of $2.5 million, or $0.19 per diluted common share in the prior period.

Speaker #2: The bottom line results from continuing sold operations fiscal a net loss of $15.7 million, or $1.07 per diluted common share, for the year, compared to a net loss of $35.3 million, or $2.61 per diluted common share, in the prior year.

Speaker #2: For fiscal 2025 , net loss from discontinued operations , net of taxes related to the Fc2 , business with $7 million , or $0.48 per diluted common share , including the $4.1 million loss on the sale of Fc2 the business , compared to a net loss of $2.5 million , or in the prior $0.19 per diluted operations .

Speaker #2: The $4.5 million increase in loss from discontinued operations is due to the loss on the sale of the condom business of $4.1 million, a reduction in gross FC2 profit of $4.3 million, and an increase in the loss from the change in value of the female derivative liabilities, partially offset by a decrease in operating expenses of $5.5 million.

Mitchell Steiner: The increase in the net loss from discontinued operations of $4.5 million is due to the loss on the sale of the FC2 female condom business of $4.1 million, a reduction in gross profit of $4.3 million, and an increase in the loss from the change in fair value of the derivative liabilities of $2.9 million, partially offset by a decrease in operating expenses of $5.5 million. Now, looking at the balance sheet, as of 30 September 2025, our cash, cash equivalents, and restricted cash balance was $15.8 million, compared to $24.9 million as of 30 September 2024. The restricted cash as of 30 September 2025, was $54,000 related to the sale of the FC2 female condom business. Subsequent to 30 September 2025, we completed a public offering that resulted in net proceeds to the company of approximately $23.4 million.

The increase in the net loss from discontinued operations of $4.5 million is due to the loss on the sale of the FC2 female condom business of $4.1 million, a reduction in gross profit of $4.3 million, and an increase in the loss from the change in fair value of the derivative liabilities of $2.9 million, partially offset by a decrease in operating expenses of $5.5 million. Now, looking at the balance sheet, as of 30 September 2025, our cash, cash equivalents, and restricted cash balance was $15.8 million, compared to $24.9 million as of 30 September 2024. The restricted cash as of 30 September 2025, was $54,000 related to the sale of the FC2 female condom business.

Speaker #2: Now , looking at the $2.9 million , balance sheet as of September 30th , 2025 , our , cash cash and restricted cash balance was $15.8 million , compared to $24.9 million as of September 30th , 2024 .

Speaker #2: The cash restricted as of September 30th , 2025 was $54,000 . Related to the sale of the Fc2 female condom business . Subsequent to September 30th , 2025 , we completed a public offering that resulted in net proceeds to the of company approximately $23.4 million .

Subsequent to 30 September 2025, we completed a public offering that resulted in net proceeds to the company of approximately $23.4 million. Our net working capital was $11.1 million on 30 September 2025, compared to $23.4 million on 30 September 2024. The company is not profitable and has had negative cash flow from operations. We will need additional capital to support our drug development candidates.

Speaker #2: Our net working capital was $11.1 million on September 30th , 2025 , compared to September 30th , $23.4 million on 2024 . The is not company profitable and has negative cash flow from operations .

Mitchell Steiner: Our net working capital was $11.1 million on 30 September 2025, compared to $23.4 million on 30 September 2024. The company is not profitable and has had negative cash flow from operations. We will need additional capital to support our drug development candidates. Based on the company's current operating plan, our cash, as of the issuance date of these financial statements, is sufficient for the company to fund operations through the interim analysis in the Phase 2b PLATEAU clinical study to assess percent change from baseline in lean body mass, and fat mass, as measured by DEXA scans. During the year, we used cash of $30 million for operating activities, compared with $21.7 million used for operating activities in the prior year. We generated cash from investing activities of $25.1 million for fiscal 2025, compared with $0.1 million from investing activities in the prior year.

Speaker #2: We will need additional capital to had development candidates support our drug based on the company's current operating plan . Our of the issuance date of these financial statements cash as is the company to fund operations through the interim sufficient for analysis in the phase two plateau clinical study to assess percent change from in lean body mass and fat baseline mass , as measured by Dexa scans during the year , we use cash , of $30 million for operating activities , compared with $21.7 million used for operating activities in the prior year .

Based on the company's current operating plan, our cash, as of the issuance date of these financial statements, is sufficient for the company to fund operations through the interim analysis in the Phase 2b PLATEAU clinical study to assess percent change from baseline in lean body mass, and fat mass, as measured by DEXA scans. During the year, we used cash of $30 million for operating activities, compared with $21.7 million used for operating activities in the prior year. We generated cash from investing activities of $25.1 million for fiscal 2025, compared with $0.1 million from investing activities in the prior year.

Speaker #2: We generated cash from investing activities for fiscal 2025, compared with $0.1 million from $25.1 million in investing in the prior year. The cash generated in the current year relates to net proceeds from the sale of the FC2 female condom business of $16.5 million, and proceeds of $8.3 million from the sale of the Intact.

Speaker #2: We generated cash from investing activities of for fiscal 2025 , compared with $0.1 million from $25.1 million investing prior year in the . The cash generating the current year relates to net proceeds from the sale of the Fc2 female condom business of in $16.5 million , proceeds of $8.3 million from the sale of the intact . used cash and financing We activities for assets 2025 fiscal of $4.2 million change related to the of control payment pursuant to the residual royalty agreement , which terminated in conjunction with the sale of the Fc2 female condom business in the year , we prior generated $36.8 million from financing activities .

Mitchell Steiner: The cash generated in the current year relates to net proceeds from the sale of the FC2 female condom business of $16.5 million and proceeds of $8.3 million from the sale of the Entadfi assets. We used cash in financing activities for fiscal 2025 of $4.2 million related to the change of control payment pursuant to the residual royalty agreement, which terminated in conjunction with the sale of the FC2 female condom business. In the prior year, we generated $36.8 million from financing activities. Now, I'd like to turn the call back to Dr. Steiner. Dr. Steiner? Thank you, Michele. And with that, I'll now open the call to questions. Operator? Ladies and gentlemen, at this time, we will begin the question and answer session. To ask a question, you may press star, then one on your telephone keypad.

The cash generated in the current year relates to net proceeds from the sale of the FC2 female condom business of $16.5 million and proceeds of $8.3 million from the sale of the Entadfi assets. We used cash in financing activities for fiscal 2025 of $4.2 million related to the change of control payment pursuant to the residual royalty agreement, which terminated in conjunction with the sale of the FC2 female condom business. In the prior year, we generated $36.8 million from financing activities. Now, I'd like to turn the call back to Dr. Steiner. Dr. Steiner?

Speaker #2: Now , I'd like to turn the call back to Doctor Doctor Steiner Steiner . .

Speaker #1: Thank you, Michele. And with that, I'll now open the call to questions. Operator.

Mitchell Steiner: Thank you, Michele. And with that, I'll now open the call to questions. Operator?

Speaker #3: Ladies . and gentlemen , at this time , we will begin the question and answer session . To ask a may star , then question , you one on your telephone press keypad are using a .

Operator: Ladies and gentlemen, at this time, we will begin the question and answer session. To ask a question, you may press star, then one on your telephone keypad. If you are using a speakerphone, we ask that you please pick up your handset before pressing the keys to ensure the best sound quality. To withdraw your question, please press star, then two. Please limit yourself to one question and one follow-up. If you have further questions, you may re-enter the question queue. Once again, that is star, then one to rejoin the question queue. We will pause momentarily to assemble our roster. The first question today comes from William Wood with B. Riley Securities. Please go ahead.

Speaker #3: If you are using speakerphone, we ask that you please pick up your handset before pressing the keys to ensure the best sound quality. To withdraw your question, please press star then two.

Mitchell Steiner: If you are using a speakerphone, we ask that you please pick up your handset before pressing the keys to ensure the best sound quality. To withdraw your question, please press star, then two. Please limit yourself to one question and one follow-up. If you have further questions, you may re-enter the question queue. Once again, that is star, then one to rejoin the question queue. We will pause momentarily to assemble our roster. The first question today comes from William Wood with B. Riley Securities. Please go ahead. Hi, yes. Thanks for taking our questions and congrats on a successful year. I'm just kind of curious, in your press release for Plateau, you noted that there's going to be an inclusion of GLP-1, whereas at least in the past, you've spoken of using only tirzepatide, which is highlighted in your most recent deck.

Speaker #3: Please limit yourself question one and one follow to up if you have further may questions , you reenter the question queue . Once again , that is star .

Speaker #3: Then, one to rejoin the question, we will pause momentarily to queue and assemble our roster. The first question today comes from William Wood with Riley Securities.

Speaker #3: Please go ahead .

Speaker #4: Hi . Yes , thanks for taking our questions . And congrats on a successful year . just kind of curious in your in I'm your for press release noted that there's going to be plateau , you an inclusion of GLP one , at least in the past you've whereas spoken of only Tirzepatide , using which is highlighted in your most recent deck plateau , during there's the potential for 2.4 , 7.2 , 25 mcg oral Sema , and then oral for and then obviously also to all be tirzepatide approved .

William Wood: Hi, yes. Thanks for taking our questions and congrats on a successful year. I'm just kind of curious, in your press release for Plateau, you noted that there's going to be an inclusion of GLP-1, whereas at least in the past, you've spoken of using only tirzepatide, which is highlighted in your most recent deck. During Plateau, there's the potential for 2.4mg semi, 7.2mg semi, 25mg oral semi, and then oral full, and then obviously also tirzepatide to all be approved. So I'm just curious, will any GLP-1 be allowed in your Phase 2b, or will it be limited to just tirzepatide? And curious how we should sort of view the potential to achieve this 5% weight loss bar when placed with various agents.

Mitchell Steiner: During Plateau, there's the potential for 2.4mg semi, 7.2mg semi, 25mg oral semi, and then oral full, and then obviously also tirzepatide to all be approved. So I'm just curious, will any GLP-1 be allowed in your Phase 2b, or will it be limited to just tirzepatide? And curious how we should sort of view the potential to achieve this 5% weight loss bar when placed with various agents. Do you feel that that remains the same, or is sort of lower or higher initial weight loss better to sort of set you up for success? And I have a follow-up. Great question. Thank you for the question. So basically, the question is, we're saying GLP-1 receptor agonists, but yet we're putting tirzepatide in the "placeholder" in the study.

Speaker #4: So I'm just a little curious, will GLP-1 be allowed in your Phase 2b, or will it be limited to just tirzepatide? And how should we sort of view the potential to achieve this weight loss bar—when 5% weight loss is achieved—with various agents? I was just curious.

Speaker #4: Does that feel like it remains the same, or is it sort of lower or higher than the initial weight? Is weight loss sort of set up for your success?

Do you feel that that remains the same, or is sort of lower or higher initial weight loss better to sort of set you up for success? And I have a follow-up.

Speaker #4: And I have a...?

Speaker #1: question . Thank you

Speaker #1: basically the question Great , you know , is we're saying GLP agonist , but yet putting to appetite in the quote placeholder in the study one receptor raises the question , are we're you're going to allow Better Semaglutide and Tirzepatide , both which are two approved GLP one receptor right out there agonists that are now .

Mitchell Steiner: Great question. Thank you for the question. So basically, the question is, we're saying GLP-1 receptor agonists, but yet we're putting tirzepatide in the "placeholder" in the study. It raises the question of are you going to allow both semaglutide and tirzepatide, which are the two approved GLP-1 receptor agonists that are out there right now? The answer is we have to pick one because they are different. The last thing you want to do is add variability to the study by having tirzepatide and semaglutide together. We're in the process of chatting and trying to secure one or the other. So based on that, we'll determine ultimately which one it will be. At this point, the placeholder is tirzepatide, but it could be semaglutide.

Mitchell Steiner: It raises the question of are you going to allow both semaglutide and tirzepatide, which are the two approved GLP-1 receptor agonists that are out there right now? The answer is we have to pick one because they are different. The last thing you want to do is add variability to the study by having tirzepatide and semaglutide together. We're in the process of chatting and trying to secure one or the other. So based on that, we'll determine ultimately which one it will be. At this point, the placeholder is tirzepatide, but it could be semaglutide. In either case, it should be one or the other and not allowing for both. Got it. That's helpful.

Speaker #1: And the, the, in the, and the answer is we have to pick one. And because, you know, there are different.

Speaker #1: And the idea is to add variability to the study—last thing you do—by having Tirzepatide and semaglutide together. We're in a chatting and trying to secure process of other.

Speaker #1: And so one or the based that , on determine ultimately which one will be at this point . The placeholders does we'll appetite it could be , but some in .

Speaker #1: Either case, it should be one or the other and not, but the the allowing for both.

In either case, it should be one or the other and not allowing for both.

Speaker #4: it . Got That's helpful . And then also when thinking about sort of the phase two to phase three transition , do you have any insight on I know you've that said the FDA would allow you for if don't achieve that , that 5% bar , they allow us to would incorporate or to look towards , functional say , a improvement like strength , specifically stair climb .

William Wood: Got it. That's helpful. Then also, when thinking about sort of the phase 2 to phase 3 transition, do you have any insight on? I know you said that the FDA would allow for, if you don't achieve that 5% bar, they would allow to incorporate or to look towards, say, a functional improvement like strength, specifically stair-climb. But how does that set up in phase 3? Is that set up a dual endpoint in phase 3 where you have to have where it's sort of an and/or dual primary endpoint, or would they allow just a functional endpoint? How should we be thinking about that?

Mitchell Steiner: Then also, when thinking about sort of the phase 2 to phase 3 transition, do you have any insight on? I know you said that the FDA would allow for, if you don't achieve that 5% bar, they would allow to incorporate or to look towards, say, a functional improvement like strength, specifically stair-climb. But how does that set up in phase 3? Is that set up a dual endpoint in phase 3 where you have to have where it's sort of an and/or dual primary endpoint, or would they allow just a functional endpoint? How should we be thinking about that? I'll tell you exactly how to be thinking about it. It's a great question. The reason we didn't go to phase 3 is because we wanted to answer that question before you move to an expensive phase 3. Okay?

Speaker #4: But how does that set up? Does that set up a phase three in a dual endpoint in phase two to have, you know, where it's sort of an 'and/or' as your primary endpoint? Or would they do three, where you allow just functional?

Speaker #4: How should endpoint dual we be about

Speaker #1: So

Speaker #1: You exactly how to be thinking about it. It's a great question. So that? To go to phase three is because we wanted to answer that question before you move to an expensive phase three.

Mitchell Steiner: I'll tell you exactly how to be thinking about it. It's a great question. The reason we didn't go to phase 3 is because we wanted to answer that question before you move to an expensive phase 3. Okay? So the idea is do a Phase 2b and make the primary endpoint incremental weight loss. And so we know exactly how these agents are going to behave just like in a Phase 3 setting. So they have the titration period and the maintenance period of 52 weeks, same exact criteria that the FDA wants with a Phase 3. So it's basically a mini Phase 3. And so then we'll know exactly what that incremental weight loss over time will be.

Speaker #1: Okay. So the idea is to do a Phase 2b and make the primary endpoint incremental weight loss. And so we know exactly how it can behave.

Mitchell Steiner: So the idea is do a Phase 2b and make the primary endpoint incremental weight loss. And so we know exactly how these agents are going to behave just like in a Phase 3 setting. So they have the titration period and the maintenance period of 52 weeks, same exact criteria that the FDA wants with a Phase 3. So it's basically a mini Phase 3. And so then we'll know exactly what that incremental weight loss over time will be. Then to make sure that it's very clear that we're focusing on body composition and function, the key secondary endpoints, and I mentioned in my comments, are going to be heavily weighted on getting an understanding of what happens at 72 weeks. So basically, your titration period followed by your maintenance period.

Speaker #1: Just these agents, like in the Phase 3 setting. So, they have maintenance, they have a titration period, and the period is 52 weeks.

Speaker #1: Same exact the criteria . The FDA wants with the maintenance three . So so it's basically phase a mini phase three . And so so then we'll know exactly what that incremental weight loss over time will .

Speaker #1: Then then to sure that make be it's very clear focusing on body composition and that we're function , the secondary and key secondary endpoints , as I mentioned in my in my comments , are heavily going to be weighted on getting an understanding of what happens at 72 weeks .

Then to make sure that it's very clear that we're focusing on body composition and function, the key secondary endpoints, and I mentioned in my comments, are going to be heavily weighted on getting an understanding of what happens at 72 weeks. So basically, your titration period followed by your maintenance period. Again, understand exactly what's going to happen in the phase 3 setting in the phase 2 setting, using the phase 2 setting. So we'll know exactly which of these points. Is it going to be stair-climb power? Is it going to be the clinical outcomes measure? Is it going to be bone mineral density? Is it going to be functional limitations? Patients come in with functional limitation, mobility disability question.

Speaker #1: So basically your maintenance , your period your followed by period . Again , titration understand you know , exactly what's going to happen in the phase three setting .

Speaker #1: In the phase two , you know , using the phase two So we'll know which of these exactly setting . points is it going to be a stair climb power .

Mitchell Steiner: Again, understand exactly what's going to happen in the phase 3 setting in the phase 2 setting, using the phase 2 setting. So we'll know exactly which of these points. Is it going to be stair-climb power? Is it going to be the clinical outcomes measure? Is it going to be bone mineral density? Is it going to be functional limitations? Patients come in with functional limitation, mobility disability question. There's two questions. And did they improve or not improve? So we're learning a lot of information on what happens at 16 weeks, but what happens now at 72 weeks? And so based on that, be very clear.

Speaker #1: Is it going to be the, the, the clinical outcomes measure? Is it going to be bone mineral density? Is it going to be functional limitations?

Speaker #1: Patients come in with functional limitation , mobility disability . Question . There's two questions . And do they improve . So we're learning a lot of information .

Speaker #1: What happens at 16 weeks? But what happens now at 72 weeks? So based on that, and so it’d be very clear.

There's two questions. And did they improve or not improve? So we're learning a lot of information on what happens at 16 weeks, but what happens now at 72 weeks? And so based on that, be very clear. We found that the FDA's feedback was very positive because it gave us options now that can range from incremental weight loss you hit, and you can bring all the physical function, body composition stuff in if clinically meaningful in the label, and you're different. You're not an incretin with an incretin, okay? Or it becomes clear that incremental weight loss could be a challenge. We don't think it will be, but let's say it is. You're not dead in the water.

Speaker #1: You know , we found that the FDA's feedback . And and very because it positive gave was very , options . Now that , you know , could that that can range from incremental weight loss .

Mitchell Steiner: We found that the FDA's feedback was very positive because it gave us options now that can range from incremental weight loss you hit, and you can bring all the physical function, body composition stuff in if clinically meaningful in the label, and you're different. You're not an incretin with an incretin, okay? Or it becomes clear that incremental weight loss could be a challenge. We don't think it will be, but let's say it is. You're not dead in the water. Now you have your physical function endpoints that can serve as your primary endpoint, your primary endpoint in phase 3. So you can see how we're using our phase 2 to guide us in our phase 3 program. Yeah. No, that's helpful. And I guess just actually one quick last one.

Speaker #1: You hit. And you can bring all the physical function, body composition stuff in if it's clinically meaningful in the label, and you’re different.

Speaker #1: You're not an incretin with incretin. Okay. Or it becomes clear, incremental weight loss is a challenge. We don't think it will be.

Speaker #1: But let's— You're not dead; could be water now. In the— is your— You have physical function endpoints that can serve as your primary endpoint, your primary endpoint in Phase 3.

Now you have your physical function endpoints that can serve as your primary endpoint, your primary endpoint in phase 3. So you can see how we're using our phase 2 to guide us in our phase 3 program.

Speaker #1: So, you can see how we're using our Phase 2 to guide us in our Phase 3 program.

Speaker #4: Yeah . No , that's that's helpful . And I guess just actually one quick last one , I know you've mentioned in the past again that to sort of go you're going for all but stratify .

William Wood: Yeah. No, that's helpful. And I guess just actually one quick last one. I know you've mentioned in the past, again, that you were going to sort of go for all comers, but it looks like you're only targeting the greater than 65 patient population now in Plateau, and that's actually sort of upped from the greater than 60 years old in Quality. So maybe just clarify what population you're targeting, and was that more FDA guidance, or Medicare reimbursement dynamics, or just sort of the most in need population? And I appreciate how it hopped back into a few things.

Mitchell Steiner: I know you've mentioned in the past, again, that you were going to sort of go for all comers, but it looks like you're only targeting the greater than 65 patient population now in Plateau, and that's actually sort of upped from the greater than 60 years old in Quality. So maybe just clarify what population you're targeting, and was that more FDA guidance, or Medicare reimbursement dynamics, or just sort of the most in need population? And I appreciate how it hopped back into a few things. So the way to think of it is if we hit our incremental weight loss, okay, then you feel more comfortable. If you hit our incremental weight loss in patients over 65, you're going to be fine in incremental weight loss in patients less than 65, okay?

Speaker #4: It looks like you're only targeting the greater than 65 patient now in population plateau. And that's actually sort of upped from the greater than 60 years old quality.

Speaker #4: It looks like you're only targeting the greater than 65 patient Now in population . plateau . And that's actually sort of upped from the greater than 60 years old in So I'm maybe , you know , just clarify what population you're you're , targeting .

Speaker #4: And was that more FDA guidance, or Medicare reimbursement dynamics, or just sort of the most in population? Yeah, need...

Speaker #4: .

Speaker #1: So, the way to think of it

Mitchell Steiner: So the way to think of it is if we hit our incremental weight loss, okay, then you feel more comfortable. If you hit our incremental weight loss in patients over 65, you're going to be fine in incremental weight loss in patients less than 65, okay? But for physical function, which is where we see ourselves benefiting and showing clinical meaningfulness, then the greater than 65 in our Phase 2b QUALITY study with the patients that were most in need, meaning they probably have a touch or more than a touch of sarcopenia, and they already have physical limitations, they're the most informative population for physical function.

Speaker #1: . But Thanks . for Okay physical function , which is where we see ourselves , you benefiting and showing clinical meaningfulness know , , then the greater than our phase two B 65 in quality study with the patients that were most in need .

Mitchell Steiner: But for physical function, which is where we see ourselves benefiting and showing clinical meaningfulness, then the greater than 65 in our Phase 2b QUALITY study with the patients that were most in need, meaning they probably have a touch or more than a touch of sarcopenia, and they already have physical limitations, they're the most informative population for physical function. If you go back and you say, "Oh, if I look at STEP 1, I look at SURMOUNT studies, the performance looks better in patients that lose weight." It does because the average age is like 50. But if you go over 65, I haven't seen a single study in which they take out patients that are 65 and older and ask the same question. They don't. And so the purpose of the Phase 2 is to find the patient population that's most in need.

Speaker #1: Meaning they probably have a touch or more than a touch of sarcopenia . They already have physical limitations . They're the most , you know , most informative population for physical function .

Speaker #1: If I look back and you say, oh, if I look at step one, I look at the UGO studies. The performance is somewhat better in those patients that lose weight.

If you go back and you say, "Oh, if I look at STEP 1, I look at SURMOUNT studies, the performance looks better in patients that lose weight." It does because the average age is like 50. But if you go over 65, I haven't seen a single study in which they take out patients that are 65 and older and ask the same question. They don't. And so the purpose of the Phase 2 is to find the patient population that's most in need. The FDA has guided that if you choose as a primary endpoint physical function and body composition endpoints, that being older, greater than 65, and quite frankly, even being younger than 65, there's no indication.

Speaker #1: It does average because the age is like 50. But if you go over 65, I haven't seen a single study in which they take out patients.

Speaker #1: 65 and older . And ask the same question . They don't . And so , the so , so phase the two is purpose of the to find patient that's most in population need .

Speaker #1: The FDA has guided that if you choose , if choose as a primary endpoint , you physical and body composition endpoints , that being older , greater than 65 and quite frankly , even being younger than there's no indication .

Mitchell Steiner: The FDA has guided that if you choose as a primary endpoint physical function and body composition endpoints, that being older, greater than 65, and quite frankly, even being younger than 65, there's no indication. So even if you hit incremental weight loss and you want a secondary endpoint of physical function, you have to say what patient population has to be pre-specified. If you read the guidance, it says you have to pre-specify. So in other words, if a 32-year-old linebacker is going to lose weight and not get into trouble because they have a lot of muscle reserve, then that'll be a bad patient to tell you whether or not you're going to make the functional limitations better.

Speaker #1: So even even if you hit incremental weight loss and you want a secondary endpoint , a physical function , you have to say what patient population has to be pre-specified .

So even if you hit incremental weight loss and you want a secondary endpoint of physical function, you have to say what patient population has to be pre-specified. If you read the guidance, it says you have to pre-specify. So in other words, if a 32-year-old linebacker is going to lose weight and not get into trouble because they have a lot of muscle reserve, then that'll be a bad patient to tell you whether or not you're going to make the functional limitations better. So even in the setting where incremental weight loss you hit, and you want your secondary endpoint to be physical function, you can do a pre-specified subset and put that into the full Phase 3.

Speaker #1: the guidance , it says you have to pre-specify . So If you read in other words , if a 32 year old linebacker is going to lose weight and not get into trouble because they have a lot of muscle reserve , then that'll be a bad patient to tell you whether or going to make the functional limitations better .

Speaker #1: So even in the setting where incremental weight loss , you not you're hit and you want to secondary to be physical can do a function , pre-specified you subset into the that full phase three .

Mitchell Steiner: So even in the setting where incremental weight loss you hit, and you want your secondary endpoint to be physical function, you can do a pre-specified subset and put that into the full Phase 3. So you do all comers, and then you pre-specify a subset, in this case, greater than 65. So by having this Phase 2b plateau study, we'll know exactly how that patient population will behave. And so we hit incremental weight loss, we expand it to all patients, and we pre-specify an older patient population that we want to have functional endpoints measured. Again, you read the guidance, that's acceptable. On the other hand, if you don't hit incremental weight loss and you go forward, being older than 65 is not a disease.

Speaker #1: So you and put do all comers and then you pre-specify a subset . In this case greater than 65 . by So having this phase two B plateau study , we'll know exactly how that patient population will behave .

So you do all comers, and then you pre-specify a subset, in this case, greater than 65. So by having this Phase 2b plateau study, we'll know exactly how that patient population will behave. And so we hit incremental weight loss, we expand it to all patients, and we pre-specify an older patient population that we want to have functional endpoints measured. Again, you read the guidance, that's acceptable. On the other hand, if you don't hit incremental weight loss and you go forward, being older than 65 is not a disease.

Speaker #1: And so, it hit, so we incremental weight loss. We expand it to all patients. And we pre-specify an older patient population that we functionally want to have endpoints measured.

Speaker #1: Again , you read the guidance acceptable . On the that's other hand , if you don't hit incremental weight loss . And you go forward being 65 is not a older than And so disease .

Speaker #1: therefore you have to take oldest 65 and functional limitations older than 65 , something in the patient population . You know , problems with average activities of daily living , problems with with functional tests like stair climb .

Mitchell Steiner: Therefore, you have to say older than 65 and functional limitations, older than 65, something in the patient population, problems with activities of daily living, problems with functional tests like stair-climb. So this Phase 2b really will give us the information that we need to make sure that if we go with a primary endpoint in physical function, that we have the right indication in the right patient population. So as you see, we set ourselves up for all the options, and now run the study, take a step back between the Phase 2b QUALITY study and the Phase 2b PLATEAU study. Now you're going to feel pretty good you've de-risked the program for multiple options going forward.

Therefore, you have to say older than 65 and functional limitations, older than 65, something in the patient population, problems with activities of daily living, problems with functional tests like stair-climb. So this Phase 2b really will give us the information that we need to make sure that if we go with a primary endpoint in physical function, that we have the right indication in the right patient population. So as you see, we set ourselves up for all the options, and now run the study, take a step back between the Phase 2b QUALITY study and the Phase 2b PLATEAU study. Now you're going to feel pretty good you've de-risked the program for multiple options going forward.

Speaker #1: So , so this phase two B really will give us the information that we need make to to sure that if we go with a primary endpoint , physical function , we that have the right indication and the right patient population .

Speaker #1: as you see , we set ourselves up for all so And options . the run the take a step study , back to phase two B quality study .

Speaker #1: And the phase two B study . You know now now you're going to feel You plateau the de-risked program for multiple pretty good .

Speaker #1: Going multiple, going forward. So, incremental weight loss again, a secondary endpoint—physical function in the right patient options with, or physical functions.

Mitchell Steiner: So again, incremental weight loss with a secondary endpoint, physical function in the right patient population, or physical function to your primary endpoint, incremental weight loss is not because you're at the same weight loss, but you have the right patient population, the sarcopenic obese patient over the age of 65 that is afraid to go on GLP-1s. Can you help that patient population? Which, by the way, 44 million Americans are in Part D of Medicare, of which half can benefit from a weight loss drug. It's a massive market. So we're playing with big numbers. Got it. Makes sense. Very helpful. I'll hop back into queue. Thanks, Mitch. Thank you. While we're waiting for the next question, I just have a couple of comments to make. So first of all, as we reflect back over the year, because this is year-end, maybe some personal comments from me.

So again, incremental weight loss with a secondary endpoint, physical function in the right patient population, or physical function to your primary endpoint, incremental weight loss is not because you're at the same weight loss, but you have the right patient population, the sarcopenic obese patient over the age of 65 that is afraid to go on GLP-1s. Can you help that patient population? Which, by the way, 44 million Americans are in Part D of Medicare, of which half can benefit from a weight loss drug. It's a massive market. So we're playing with big numbers.

Speaker #1: primary endpoint , incremental weight loss is not because you're at the same weight loss , but you have the right patient population . sarcopenic The obese patient over the age of 65 , that is afraid to go on GLP one , you know , can you help that patient population , by the way , which , Your 44 million Americans in part D and are Medicare , of which benefit half can loss , weight loss , drugs , a massive market .

Speaker #1: So, you know, we're playing with big, firm weight numbers.

Speaker #4: Got it. Makes sense, and very helpful. I'll hop back in the queue then. Thanks,

William Wood: Got it. Makes sense. Very helpful. I'll hop back into queue. Thanks, Mitch.

Speaker #5: .

Speaker #1: While we're waiting for the

Speaker #1: just have a question , I couple of you comments to make . So first of we reflect back over the year , because this is year end all , as , you know , I next , you know , maybe , maybe comments personal from me some .

Mitchell Steiner: Thank you. While we're waiting for the next question, I just have a couple of comments to make. So first of all, as we reflect back over the year, because this is year-end, maybe some personal comments from me. First of all, we went into a field that was completely unknown. We had data in cancer patients. We had data in older patients. Are these patients with pharmacological-induced low-calorie situation different? And guess what? They are different. They are different. And so much so that when you look at these myostatin inhibitors, because now these other companies have reported, if not complete phase 2, partial phase 2 data, it's hard to hold on to lean mass.

Speaker #1: You know, first of all, we went into a field that was completely unknown. We had data in cancer patients, data in older patients.

Speaker #1: who had know , are these patients induced , low But , you calorie pharmacological situation different ? And what ? They are guess different .

Mitchell Steiner: First of all, we went into a field that was completely unknown. We had data in cancer patients. We had data in older patients. Are these patients with pharmacological-induced low-calorie situation different? And guess what? They are different. They are different. And so much so that when you look at these myostatin inhibitors, because now these other companies have reported, if not complete phase 2, partial phase 2 data, it's hard to hold on to lean mass. It's hard to hold on to lean mass. And you'll see the six-month data and even the year data. So this is a different patient population. With that said, the enobosarm performed very nicely. So we were able to show 100% lean mass, we burned fat for good physical function. And then the statement that came back, how about safety?

Speaker #1: They are different . And and so much so that with when you look at these inhibitors , because now now these other have reported , if not complete phase two , partial phase two data .

Speaker #1: hard to hold on to lean mass . It's companies It's hard to hold on to lean mass . And you'll see the six months data .

Speaker #1: And even in the data year . So so this is a different patient population . With that said , Enobosarm performed very nicely , so we were able to show you mass burn 100% lean fat on physical function , and then the statement came back , how about safety ?

It's hard to hold on to lean mass. And you'll see the six-month data and even the year data. So this is a different patient population. With that said, the enobosarm performed very nicely. So we were able to show 100% lean mass, we burned fat for good physical function. And then the statement that came back, how about safety? Because safety took us some more time to get safety because the study was still blinded. Safety came back great. In fact, we look like we make GI toxicity better for the GLP-1. And so we're very, very excited about that. So from a year standpoint, looking back at the year, I think we achieved what we needed to do with the trial.

Speaker #1: Because safety took us more—get safety because the study was still blinded. Safety came back great. In fact, we took time to look, and it looks like we make GI toxicity better for the GLP one.

Mitchell Steiner: Because safety took us some more time to get safety because the study was still blinded. Safety came back great. In fact, we look like we make GI toxicity better for the GLP-1. And so we're very, very excited about that. So from a year standpoint, looking back at the year, I think we achieved what we needed to do with the trial. Then the competitive landscape, the other companies, Scholar Rock, Regeneron, Versanis, and Lilly reported. And that was very, very helpful. Remember, we're oral. They're an injectable. And they have their own unique, interesting safety signals. And that's because myostatin inhibitors are very ubiquitous, and we're still learning about them. But the point is that we learned from that. What did we learn?

Speaker #1: And so about that . So so excited from year very back at the year we think did , I we achieved what we needed to we're very , do with the trial .

Speaker #1: Then the competitive landscape , the other companies . Scholar Rock , Regeneron , Lilly reported . And and very , very helpful because remember , we're oral and injectable that was and and they have , you know , they have their own unique , interesting signals .

Then the competitive landscape, the other companies, Scholar Rock, Regeneron, Versanis, and Lilly reported. And that was very, very helpful. Remember, we're oral. They're an injectable. And they have their own unique, interesting safety signals. And that's because myostatin inhibitors are very ubiquitous, and we're still learning about them. But the point is that we learned from that. What did we learn? One of the things I heard over and over, "Oh, Mitch, if you hold on to muscle, muscle weighs more than fat, that you're going to have people that actually gain weight on your anabolic agent. And forget about incremental weight loss. You may be in a situation where you have to accept less weight loss." It didn't happen.

Speaker #1: And , because , safety you know , my inhibitors are very and that's ubiquitous . And they're still we're still learning about them .

Speaker #1: But but the point is that from that . What did we learn ? One of the things I and over , oh , Mitch , if heard over muscle , muscle than on to You're going to fat .

Speaker #1: weighs more people that actually gain have weight on your on your anabolic agent . And and forget about incremental weight loss . You may be in a situation where you have to accept less weight loss .

Mitchell Steiner: One of the things I heard over and over, "Oh, Mitch, if you hold on to muscle, muscle weighs more than fat, that you're going to have people that actually gain weight on your anabolic agent. And forget about incremental weight loss. You may be in a situation where you have to accept less weight loss." It didn't happen. It didn't happen for us, and it didn't happen for them. So if you give an anabolic agent, there's not an instance where you lost less weight. In fact, with time and holding on to more lean mass, as shown by the Versanis, Lilly data, that by 72 weeks, they had a 6.4% incremental weight loss. 6.4% incremental weight loss. What that's supporting is that if you hold on to metabolic muscle that burns more calories every day than other tissue, that ultimately the turtle wins the race, not the rabbit.

Speaker #1: It didn't happen . It happen for us . It didn't happen for them . you're given didn't anabolic agent , there's So if not an instance where you lost less weight .

It didn't happen for us, and it didn't happen for them. So if you give an anabolic agent, there's not an instance where you lost less weight. In fact, with time and holding on to more lean mass, as shown by the Versanis, Lilly data, that by 72 weeks, they had a 6.4% incremental weight loss. 6.4% incremental weight loss. What that's supporting is that if you hold on to metabolic muscle that burns more calories every day than other tissue, that ultimately the turtle wins the race, not the rabbit.

Speaker #1: fact , In with with time and with time and holding on to lean mass as shown by the data more that by 72 weeks they had a 6.4% loss .

Speaker #1: incremental weight 6.4% incremental weight . With that loss supporting is that you if if you hold on to metabolic muscle , that calories every burns more day than other tissue that ultimately the turtle wins the race , not the rabbit .

Speaker #1: The turtle race . And you end up with more wins the loss . So that weight was important . Then the statement came back , okay , now we need regulatory clarity .

Mitchell Steiner: The turtle wins the race, and you end up with more weight loss. So that was important. Then the statement came back, "Okay, now we need regulatory clarity." Well, guess what? Yes, it's evolving. Yes, the FDA changed their mind. Because why would we do a 16-week study if incremental weight loss was the primary endpoint? That makes no sense. Well, that's because the FDA told us that incremental weight loss by itself would not work. In the case of our drug, functional endpoints, the function should be the endpoint. That's what we did. Why did we pick 16 weeks? Because in all the previous five other studies in a thousand patients, 16 weeks will show it. Guess what? It did.

The turtle wins the race, and you end up with more weight loss. So that was important. Then the statement came back, "Okay, now we need regulatory clarity." Well, guess what? Yes, it's evolving. Yes, the FDA changed their mind. Because why would we do a 16-week study if incremental weight loss was the primary endpoint? That makes no sense. Well, that's because the FDA told us that incremental weight loss by itself would not work. In the case of our drug, functional endpoints, the function should be the endpoint. That's what we did. Why did we pick 16 weeks? Because in all the previous five other studies in a thousand patients, 16 weeks will show it. Guess what? It did.

Speaker #1: Well , guess what ? Yes , it's evolving . Yes , the FDA changed their mind because why would we do a 16 week study if incremental weight loss was the primary endpoint ?

Speaker #1: no That makes sense . Well , the FDA told that's because us that loss incremental weight by itself was not work . That that in the case of our drug functional limitation , functional endpoints as function should endpoint .

Speaker #1: be the That's what we Why do we pick 16 weeks ? Because all the did . previous five other studies in a thousand patients , 16 weeks will show it .

Speaker #1: what Guess it did ? Then the FDA changed their thinking actually gave us an option to to . Now that we know incremental weight loss and and anabolic agents can happen and and we you know , we saw in some of our data that we saw weight loss in cancer patients who were some of the obese .

Mitchell Steiner: Then the FDA changed their thinking and actually gave us an option to, now that we know incremental weight loss and anabolic agents can happen, and we saw in some of our data that we saw weight loss in some of the cancer patients who are obese, this could be very, very interesting. This is a sometimes they say the FDA moves the goalposts. Well, in this case, they moved it towards us because they gave us an opportunity to have multiple ways to get the physical function information into the label. So I'm very happy about that. And so our new trial design, as I just went through with questions from Dr.

Then the FDA changed their thinking and actually gave us an option to, now that we know incremental weight loss and anabolic agents can happen, and we saw in some of our data that we saw weight loss in some of the cancer patients who are obese, this could be very, very interesting. This is a sometimes they say the FDA moves the goalposts. Well, in this case, they moved it towards us because they gave us an opportunity to have multiple ways to get the physical function information into the label. So I'm very happy about that. And so our new trial design, as I just went through with questions from Dr.

Speaker #1: This could be very , very interesting . This is a , you know , sometimes they say the FDA moves to goalposts . Well , in this case they moved to towards us because they gave us an opportunity to have multiple ways to get the physical function information into the label .

Speaker #1: I'm very So happy about that . And so our new trial design , as I just went through with questions from questions from doctor , would .

Speaker #1: You'll see that we've up to have set this multiple opportunities for us to understand what the phase three program could be from an everybody and a subset of extremely physical function to just the patients need that need a GLP one , but most in can't take it because they have sarcopenic obesity .

Mitchell Steiner: Wood, you'll see that we've set this up to have multiple opportunities for us to understand what the phase 3 program could be from an extreme of everybody, and a subset of physical function, to just the patients most in need that need a GLP-1 but can't take it because they have sarcopenic obesity, and that's a big number. And finally, we raised money. We had money. We had a public offering. We had money in the bank. We put ourselves in a position to move forward on the trial. So we're very happy that's behind us. Some pushback was the IP. The IP, okay. We're a new chemical entity. Our method of use patents, which are now about five of them. If issued, we'll get us to 2043. 2043 is a long time from now.

Wood, you'll see that we've set this up to have multiple opportunities for us to understand what the phase 3 program could be from an extreme of everybody, and a subset of physical function, to just the patients most in need that need a GLP-1 but can't take it because they have sarcopenic obesity, and that's a big number. And finally, we raised money. We had money. We had a public offering. We had money in the bank. We put ourselves in a position to move forward on the trial. So we're very happy that's behind us. Some pushback was the IP. The IP, okay. We're a new chemical entity. Our method of use patents, which are now about five of them. If issued, we'll get us to 2043. 2043 is a long time from now.

Speaker #1: and that's a And big number . And we raised money . We have finally , money . raised we had a public offering .

Speaker #1: We had we in the bank. We put ourselves in a to to move forward on the position trial. So we're very, very that's behind us, happy.

Speaker #1: . Some pushback . Was the IP IP . Okay , the a new chemical . You know , we're entity . of use patents , which are now about five of them Our method issued , will get us to 2043 .

Speaker #1: 2043 is a long time from now. And then, to be sure, we made sure we made a new formulation of a novozyme.

Speaker #1: We've reported it that we have that new formulation in Novasome . We filed patents on that new formulation They'll take it to . 2040 6X3 and , in the phase will be the commercial , that three and only formulation that and used in those times .

Mitchell Steiner: And then to be sure, we made sure we made a new formulation of the enobosarm. We've reported that we have that new formulation of enobosarm. We filed patents on that new formulation. They'll take it to 2046, expiry. In the phase 3 and commercial, that will be the only formulation that'll be used. Enobosarm is a new chemical entity. It doesn't exist out there. It's never been approved. So we put ourselves in a good position. Finally, pharma validation, and so we're working on it. I think we've checked all the boxes to show that we have a robust program.

And then to be sure, we made sure we made a new formulation of the enobosarm. We've reported that we have that new formulation of enobosarm. We filed patents on that new formulation. They'll take it to 2046, expiry. In the phase 3 and commercial, that will be the only formulation that'll be used. Enobosarm is a new chemical entity. It doesn't exist out there. It's never been approved. So we put ourselves in a good position. Finally, pharma validation, and so we're working on it. I think we've checked all the boxes to show that we have a robust program.

Speaker #1: A new chemical entity . It doesn't exist out there . It's never been approved . So we put ourselves in good position . And finally , pharma validation .

Speaker #1: And so that's what we're working on. And so I think we've checked all the boxes to show that we have a robust program.

Speaker #1: And this year has been a really pivotal year to put us in a very strong footing, to be an oral agent.

Mitchell Steiner: And this year has been a really pivotal year to put us in a very strong footing to be an oral agent that could be potentially combined with some of the oral agents that are being developed by Big Pharma, where they're noticing that the oral agents aren't quite matching the injectables in terms of weight loss. So an oral agent, small molecule that's for weight loss and incretin in combination with enobosarm could be very interesting, and particularly if you can potentially have similar weight loss with the combination therapy as you do with the injectables. The next question comes from Rohan Matter with Oppenheimer. Please go ahead. Hey, this is Rohan on for Leland. Thanks for the update. Just one question for me.

And this year has been a really pivotal year to put us in a very strong footing to be an oral agent that could be potentially combined with some of the oral agents that are being developed by Big Pharma, where they're noticing that the oral agents aren't quite matching the injectables in terms of weight loss. So an oral agent, small molecule that's for weight loss and incretin in combination with enobosarm could be very interesting, and particularly if you can potentially have similar weight loss with the combination therapy as you do with the injectables.

Speaker #1: That could potentially be combined with some of the oral agents that are being developed by Big Pharma, where they're noticing that the oral agents aren't quite matching the injectables in terms of loss.

Speaker #1: So , you know , so an oral agent , small molecule , that's for weight loss , incretin of weight and combination could be very interesting .

Speaker #1: And particularly if you can, enobosarm potentially can have similar weight loss with the combination as you do with the therapy injectables.

Operator: The next question comes from Rohan Matter with Oppenheimer. Please go ahead.

Speaker #3: Next, the question comes from Rohan Matter with Oppenheimer. Please go ahead.

Speaker #6: Hey , this is Rohan on for Leland . Thanks for the update . Just one question from me as you think about the different outcomes from the plateau study and the benefits of Anovas arm , do you expect obvious there to be any flexibility around , you know , regulatory discussions that would follow when it comes to showing a certain degree of weight loss or muscle function ?

Rohan Mathur: Hey, this is Rohan on for Leland. Thanks for the update. Just one question for me. As you think about the different outcomes from the plateau study and the obvious benefits of the enobosarm, do you expect there to be any flexibility around regulatory discussions that would follow when it comes to showing a certain degree of weight loss or muscle function? Thanks.

Mitchell Steiner: As you think about the different outcomes from the plateau study and the obvious benefits of the enobosarm, do you expect there to be any flexibility around regulatory discussions that would follow when it comes to showing a certain degree of weight loss or muscle function? Thanks. Yeah. So the degree of weight loss, the stake in the ground looks like 5% or greater placebo-corrected gets you to incremental weight loss. If you have the incremental weight loss, then all the secondary stuff will come in based on clinical meaningfulness. So that gets to the next question. That is, for part of our homework in the Phase 2b PLATEAU study, and you can see we put a lot of options on physical function. We did physical function tests, which is stair-climb tests, function tests. They don't like strength tests.

Speaker #6: Thanks .

Speaker #1: Yes. If the degree of weight loss stake in the ground looks 5% or greater placebo-corrected, it gets you the incremental weight loss.

Mitchell Steiner: Yeah. So the degree of weight loss, the stake in the ground looks like 5% or greater placebo-corrected gets you to incremental weight loss. If you have the incremental weight loss, then all the secondary stuff will come in based on clinical meaningfulness. So that gets to the next question. That is, for part of our homework in the Phase 2b PLATEAU study, and you can see we put a lot of options on physical function. We did physical function tests, which is stair-climb tests, function tests. They don't like strength tests.

Speaker #1: And if you have the incremental weight loss, then all the secondary stuff will come in based on, you know, based on clinical meaningfulness.

Speaker #1: And so that gets to the question that is the next part of our homework in the phase plateau study. And you can see, we too, B, put a lot of options.

Speaker #1: lot of On physical function we did physical function tests which is stair climb test . Function test . They strength tests . We're doing clinical don't like questionnaires that have been used in many of these .

Mitchell Steiner: We're doing clinical outcomes questionnaires that have been used in many of these STEP 1s or SURMOUNT studies as well. So we have data there. If we can show an older patient population, there's improvement in terms of clinical meaningfulness. And then what's an interesting new one is this mobility disability assessment. It turns out that there's an ICD code clinicians use to diagnose frailty in older patients for mobility disability that contains two questions. Question one is, can you walk two city blocks? And question two is, can you climb stairs? Something like that. And so to assess patients coming into our Phase 2b PLATEAU study and show that we can make people with functional limitations coming into the study better, that could be interesting. And so there's multiple ways to come back and present our case for the best way to measure physical function.

We're doing clinical outcomes questionnaires that have been used in many of these STEP 1s or SURMOUNT studies as well. So we have data there. If we can show an older patient population, there's improvement in terms of clinical meaningfulness. And then what's an interesting new one is this mobility disability assessment. It turns out that there's an ICD code clinicians use to diagnose frailty in older patients for mobility disability that contains two questions. Question one is, can you walk two city blocks? And question two is, can you climb stairs? Something like that.

Speaker #1: Step one surmount studies as well . So we have data there . If we can show an older patient population that's improvement . And and in terms of clinical meaningfulness .

Speaker #1: And then what's interesting new one is this mobility disability assessment . It turns out that there's an ICD code to to to to diagnose clinicians use to diagnose frailty in older patients for mobility disability .

Speaker #1: That contains two questions. Question one is, can you walk through city blocks and climb stairs? Something like, question two is, can you— And that.

Speaker #1: And so, to assess patients coming into our Phase 2 B plateau study, and show that we can make functional people who are coming into the study better.

And so to assess patients coming into our Phase 2b PLATEAU study and show that we can make people with functional limitations coming into the study better, that could be interesting. And so there's multiple ways to come back and present our case for the best way to measure physical function. One of those or all of those.

Speaker #1: That could be interesting. And so, there's multiple ways to come back and present our case for the best way to measure all those physical functions.

Speaker #6: Mitch .

Mitchell Steiner: One of those or all of those. Thanks, Mitch. Ladies and gentlemen, this concludes our question-and-answer session. I would like to turn the call back over to Dr. Mitchell Steiner for any closing remarks. Great. Thank you, operator. I appreciate everyone who joined us on today's call. I look forward to updating all of you on our progress in the next investors' call. Thank you for being with us. The digital replay of the conference call will be available beginning approximately 12:00PM Eastern Time today, 17 December, by dialing 1-855-669-9658 in the US, and 1-412-317-0088 internationally. You will be prompted to enter the replay access code, which will be 2225332. Please record your name and company when joining. The conference call has now concluded. Thank you for attending today's discussion. Goodbye.

Rohan Mathur: Thanks, Mitch.

Speaker #3: Ladies and gentlemen, this concludes our question and answer session. I would like to turn the call back over to Dr. Mitchell Steiner for any closing remarks.

Operator: Ladies and gentlemen, this concludes our question-and-answer session. I would like to turn the call back over to Dr. Mitchell Steiner for any closing remarks.

Speaker #1: Great. Operator, I appreciate everyone who joined us on today's call. Thank you. I look forward to updating all of you on our progress in the next investors call. Thank you for being with us.

Mitchell Steiner: Great. Thank you, operator. I appreciate everyone who joined us on today's call. I look forward to updating all of you on our progress in the next investors' call. Thank you for being with us.

Speaker #1: Thank

Speaker #1: .

Operator: The digital replay of the conference call will be available beginning approximately 12:00PM Eastern Time today, 17 December, by dialing 1-855-669-9658 in the US, and 1-412-317-0088 internationally. You will be prompted to enter the replay access code, which will be 2225332. Please record your name and company when joining. The conference call has now concluded. Thank you for attending today's discussion. Goodbye.

Speaker #3: The replay of the conference will be available beginning approximately 12 p.m. Eastern Time today. The call will be December 17th. Dial in by calling 1-855-669-9658 in the US and 1-412-317-0088 internationally.

Speaker #3: You will be prompted to enter the replay access code, which will be 2,225,332. Please record your name and company when joining. The conference call is now concluded.