Q3 2026 Veru Inc Earnings Call

Speaker #1: Good morning, ladies and gentlemen, and welcome to VERU INC.'s Investors Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero.

Operator: Good morning, ladies and gentlemen, and welcome to VERU INC.'s Investors Conference Call. All participants will be in 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 Fisch, VERU INC.'s Executive Director, Investor Relations and Corporate Communications. Please go ahead.

Speaker #1: 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.'s Executive Director, Investor Relations, and Corporate Communications.

Speaker #1: Please go ahead.

Speaker #2: 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, development, and product portfolio.

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 and 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.'s 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 and 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.'s Chairman, CEO, and President.

Speaker #2: 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: 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.'s Chairman, CEO, and President.

Speaker #3: Good morning. With me on this morning's call are Dr. Gary Barnett, our Chief Scientific Officer; Michele Greco, Chief Financial Officer and Chief Administrative Officer; Phil Greenberg, our General Counsel; and Sam Fish, Executive Director of Investor Relations and Corporate Communications.

Mitchell Steiner: Good morning. With me on this morning's call are Dr. Gary Barnette, our Chief Scientific Officer, Michele Greco, Chief Financial Officer and Chief Administrative Officer, Phil Greenberg, our General Counsel, and Sam Fisch, Executive Director of Investor Relations and Corporate Communications. Thank you for joining us in our Q3 fiscal year 2026 earnings call. VERU is a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases. Our drug development program consists of two novel small molecules, enobosarm and sabizabulin.

Mitchell Steiner: Good morning. With me on this morning's call are Dr. Gary Barnette, our Chief Scientific Officer, Michele Greco, Chief Financial Officer and Chief Administrative Officer, Phil Greenberg, our General Counsel, and Sam Fisch, Executive Director of Investor Relations and Corporate Communications. Thank you for joining us in our Q3 fiscal year 2026 earnings call. VERU is a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases. Our drug development program consists of two novel small molecules, enobosarm and sabizabulin.

Speaker #3: Thank you for joining us for our third quarter fiscal year 2026 earnings call. VERU is a late clinical-stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases.

Speaker #3: Our drug development program consists of two novel small molecules in novus arm and cebizabulin. The first one, a novus arm, is an oral selective angioreceptor modulator, SARM, and is being developed as a next-generation drug that, when combined with a GLP-1 receptor agonist, makes weight reduction more tissue selective for fat loss and preservation of lean mass and physical function, which is intended to lead to greater weight loss compared to a GLP-1 receptor agonist treatment alone.

Mitchell Steiner: The first one, enobosarm, is an oral selective androgen receptor modulator, SARM, and is being developed as a next generation drug that when combined with a GLP-1 receptor agonist, makes weight reduction more tissue selective for fat loss and preservation of lean mass and physical function, which is intended to lead to greater weight loss compared to a GLP-1 receptor agonist treatment alone, with a focus on older patients with obesity. Our second asset, sabizabulin, is a microtubule disruptor, and is being developed as a broad anti-inflammatory agent to reduce vascular plaque inflammation to slow the progression or promote the regression of atherosclerotic cardiovascular disease. This morning, we will focus on the update of the clinical development progress of enobosarm in our obesity program. We will also provide financial highlights for fiscal 2026, Q3 ended 30 June 2026.

Mitchell Steiner: The first one, enobosarm, is an oral selective androgen receptor modulator, SARM, and is being developed as a next generation drug that when combined with a GLP-1 receptor agonist, makes weight reduction more tissue selective for fat loss and preservation of lean mass and physical function, which is intended to lead to greater weight loss compared to a GLP-1 receptor agonist treatment alone, with a focus on older patients with obesity. Our second asset, sabizabulin, is a microtubule disruptor, and is being developed as a broad anti-inflammatory agent to reduce vascular plaque inflammation to slow the progression or promote the regression of atherosclerotic cardiovascular disease. This morning, we will focus on the update of the clinical development progress of enobosarm in our obesity program. We will also provide financial highlights for fiscal 2026, Q3 ended 30 June 2026.

Speaker #3: With a focus on older patients with obesity. Our second asset, cebizabulin, is a microtubule disruptor. It's being developed as a broad anti-inflammatory agent to reduce vascular plaque inflammation and slow the progression or promote regression of atherosclerotic cardiovascular disease.

Speaker #3: This morning, we will focus on the update of the clinical development progress of the Novus arm in our obesity program. We will also provide financial highlights for the fiscal 2026 third quarter, ended June 30, 2026.

Speaker #3: GLP-1s have been shown to produce significant weight loss in patients who are overweight or have obesity. Unfortunately, this weight loss is tissue non-selective, with a significant indiscriminate loss of both lean mass and fat mass.

Mitchell Steiner: GLP-1s have been shown to produce significant weight loss in patients who are overweight or have obesity. Unfortunately, this weight loss is tissue non-selective with a significant indiscriminate loss of both lean mass and fat mass. Of the total weight loss, up to 50% is attributable to lean mass loss. Although GLP-1 receptor agonist treatment has resulted in substantial weight loss for many patients, the strategy for the next generation of obesity drugs should be a combination therapy with GLP-1 receptor agonists to cause patients to only lose fat while preserving lean mass, physical function, and bone mineral density for the highest quality weight reduction. VERU has focused on the clinical development of enobosarm for quality weight loss in older patients who may have sarcopenic obesity.

Mitchell Steiner: GLP-1s have been shown to produce significant weight loss in patients who are overweight or have obesity. Unfortunately, this weight loss is tissue non-selective with a significant indiscriminate loss of both lean mass and fat mass. Of the total weight loss, up to 50% is attributable to lean mass loss. Although GLP-1 receptor agonist treatment has resulted in substantial weight loss for many patients, the strategy for the next generation of obesity drugs should be a combination therapy with GLP-1 receptor agonists to cause patients to only lose fat while preserving lean mass, physical function, and bone mineral density for the highest quality weight reduction. VERU has focused on the clinical development of enobosarm for quality weight loss in older patients who may have sarcopenic obesity.

Speaker #3: Of the total weight loss, up to 50% is attributable to lean mass loss. Although GLP-1 receptor agonist treatment has resulted in substantial weight loss in many patients, the strategy for the next generation of obesity drugs should be combination therapy with GLP-1 receptor agonists to cause patients to only lose fat while preserving lean mass, physical function, and bone mineral density for the highest quality weight reduction.

Speaker #3: VERU has focused on the clinical development of a novel arm for quality weight loss in older patients who may have sarcopenic obesity. This means these patients have both obesity and low muscle mass, and are potentially at the greatest risk for reduction to a critically low muscle mass, which may lead to physical function decline when taking a currently approved GLP-1 receptor agonist.

Mitchell Steiner: This means these patients have both obesity and low muscle mass and are potentially at the greatest risk for reduction to a critically low muscle mass, which may lead to physical function decline when taking a currently approved GLP-1 receptor agonist. As muscle mass loss alone does not define sarcopenia, we chose to objectively evaluate and measure physical function by a stair climb test, which is a common activity of daily living. VERU completed the Phase 2b QUALITY clinical study, which was a multi-center, double-blind, placebo-controlled, randomized dose finding clinical trial designed to evaluate the safety and efficacy of enobosarm 3 milligrams, enobosarm 6 milligrams, or placebo as a treatment to augment fat loss and prevent muscle loss in 168 older patients greater or equal to the age of 60 receiving semaglutide, which is Wegovy, for weight reduction.

Mitchell Steiner: This means these patients have both obesity and low muscle mass and are potentially at the greatest risk for reduction to a critically low muscle mass, which may lead to physical function decline when taking a currently approved GLP-1 receptor agonist. As muscle mass loss alone does not define sarcopenia, we chose to objectively evaluate and measure physical function by a stair climb test, which is a common activity of daily living. VERU completed the Phase 2b QUALITY clinical study, which was a multi-center, double-blind, placebo-controlled, randomized dose finding clinical trial designed to evaluate the safety and efficacy of enobosarm 3 milligrams, enobosarm 6 milligrams, or placebo as a treatment to augment fat loss and prevent muscle loss in 168 older patients greater or equal to the age of 60 receiving semaglutide, which is Wegovy, for weight reduction.

Speaker #3: A muscle mass loss, as muscle mass loss alone does not define sarcopenia, we chose to objectively evaluate and measure physical function by a stair climb test, which is a common activity of daily living.

Speaker #3: VERU completed the phase 2B quality clinical study which was a multi-centered double-blind placebo-controlled randomized dose finding clinical trial. Designed to evaluate the safety and efficacy of a novus arm 3 milligrams, novus arm 6 milligrams, or placebo, as a treatment to augment fat loss and prevent muscle loss in 168 older patients greater or equal to the age of 60, receiving semaglutide, which is Wegovy for weight reduction.

Speaker #3: It should be noted that the Phase 2b quality clinical trial was the first human study to demonstrate that weight reduction in older patients who have obesity, receiving a GLP-1 receptor agonist, put them at higher risk for accelerated loss of lean mass with physical function decline.

Mitchell Steiner: It should be noted that the Phase 2b QUALITY clinical trial was the first human study to demonstrate that weight reduction in older patients who have obesity receiving a GLP-1 receptor agonist put them at higher risk for accelerated loss of lean mass with physical function decline. Further, enobosarm treatment preserved lean mass muscle, which translated into a reduction in the proportion of patients that had a clinically significant stair climb physical function decline when compared to patients receiving a GLP-1 receptor agonist alone. Based on this short-term Phase 2b QUALITY study, we believe there's an urgent unmet need for a drug that prevents the loss of muscle and physical function, as well as augments the loss of fat for greater weight loss in at-risk older patients with sarcopenic obesity receiving a GLP-1 receptor agonist for weight reduction.

Mitchell Steiner: It should be noted that the Phase 2b QUALITY clinical trial was the first human study to demonstrate that weight reduction in older patients who have obesity receiving a GLP-1 receptor agonist put them at higher risk for accelerated loss of lean mass with physical function decline. Further, enobosarm treatment preserved lean mass muscle, which translated into a reduction in the proportion of patients that had a clinically significant stair climb physical function decline when compared to patients receiving a GLP-1 receptor agonist alone. Based on this short-term Phase 2b QUALITY study, we believe there's an urgent unmet need for a drug that prevents the loss of muscle and physical function, as well as augments the loss of fat for greater weight loss in at-risk older patients with sarcopenic obesity receiving a GLP-1 receptor agonist for weight reduction.

Speaker #3: Further, the Novus arm treatment preserved lean mass and muscle, which translated into a reduction in the proportion of patients that had a clinically significant stair climb physical function decline when compared to patients receiving a GLP-1 receptor agonist alone.

Speaker #3: Now, based on this short-term phase 2B quality study, we believe there’s an urgent, unmet need for a drug that prevents the loss of muscle and physical function, as well as augments the loss of fat for greater weight loss, in at-risk older patients with sarcopenic obesity receiving a GLP-1 receptor agonist for weight reduction.

Speaker #3: Now, a common and serious clinical and therapeutic challenge with GLP-1 receptor agonist treatments is that 88% of patients, after one year on a GLP-1 receptor drug, hit what's called a weight loss plateau, where they stop losing additional weight.

Mitchell Steiner: Now, a common and serious clinical and therapeutic challenge with GLP-1 receptor agonist treatments is that 88% of patients after one year on a GLP-1 receptor drug hit what's called a weight loss plateau, where they stop losing additional weight. Based on the SURMOUNT-1 study conducted by Eli Lilly and Company, 62.6% of these patients unfortunately still had clinical obesity at the time they reached this weight loss plateau of one year. One explanation might be that the non-selective loss of muscle caused by weight loss may reach a point that now stimulates the appetite in patients receiving a GLP-1 receptor agonist, so they consume more calories, which in turn may cause patients to stop losing weight and hit their weight loss plateau.

Mitchell Steiner: Now, a common and serious clinical and therapeutic challenge with GLP-1 receptor agonist treatments is that 88% of patients after one year on a GLP-1 receptor drug hit what's called a weight loss plateau, where they stop losing additional weight. Based on the SURMOUNT-1 study conducted by Eli Lilly and Company, 62.6% of these patients unfortunately still had clinical obesity at the time they reached this weight loss plateau of one year. One explanation might be that the non-selective loss of muscle caused by weight loss may reach a point that now stimulates the appetite in patients receiving a GLP-1 receptor agonist, so they consume more calories, which in turn may cause patients to stop losing weight and hit their weight loss plateau.

Speaker #3: Based on the surmount one study conducted by Eli Lilly and Company, 62.6% of these patients unfortunately still had clinical obesity at the time they reached this weight loss plateau, one year.

Speaker #3: One explanation might be that the non-selective loss of muscle caused by weight loss may reach a point that now stimulates appetite in patients receiving a GLP-1 receptor agonist so they consume more calories, which in turn may cause patients to stop losing weight and hit their weight loss plateau.

Speaker #3: The clinical issue may be potentially more problematic in older patients that start out with low muscle reserves and who lose who lost further muscle mass with weight loss, but remain obese when they hit the weight loss plateau.

Mitchell Steiner: The clinical issue may be potentially more problematic in older patients that start out with low muscle reserves and who lost further muscle mass with weight loss but remain obese when they hit the weight loss plateau. It has been shown in previous studies that enobosarm directly burns fat and preserves muscle and physical function, which will burn even more calories. Thus retaining muscle, appetite stays suppressed while more calories are burned, which could help to break through the weight loss plateau, leading to incremental weight reduction.

Mitchell Steiner: The clinical issue may be potentially more problematic in older patients that start out with low muscle reserves and who lost further muscle mass with weight loss but remain obese when they hit the weight loss plateau. It has been shown in previous studies that enobosarm directly burns fat and preserves muscle and physical function, which will burn even more calories. Thus retaining muscle, appetite stays suppressed while more calories are burned, which could help to break through the weight loss plateau, leading to incremental weight reduction.

Speaker #3: It has been shown in previous studies that a novus arm directly burns fat and preserves muscle and physical function, which you burn even more calories.

Speaker #3: Thus, retaining muscle, appetite stays suppressed while more calories are burned, which could help to break through the weight loss plateau, leading to incremental weight reduction.

Speaker #3: We are currently conducting, and have fully enrolled, the Phase 2B PLATEAU clinical trial, which is a double-blind, placebo-controlled study to evaluate the effect of a Novusarm 3 milligrams on total body weight, fat mass, lean mass, physical function, bone mineral density, and safety in approximately 200 older patients age greater than or equal to 65 who have obesity with a BMI of greater than or equal to 35, and are initiating semaglutide (Wegovy), a GLP-1 receptor agonist treatment for weight reduction.

Mitchell Steiner: We are currently conducting and have fully enrolled the Phase IIb PLATEAU clinical trial, which is a double-blind, placebo-controlled study to evaluate the effect of enobosarm three milligrams on total body weight, fat mass, lean mass, physical function, bone mineral density, and safety in approximately 200 older patients age greater than or equal to 65 who have obesity with a BMI of greater than or equal to 35 and are initiating semaglutide Wegovy GLP-1 receptor agonist treatment for weight reduction. The primary efficacy endpoint of this study is the percent change from baseline in total body weight at 68 weeks. An interim analysis will be conducted at 32 weeks to assess the percent change from baseline in lean body mass and total fat mass as measured by DEXA scan.

Mitchell Steiner: We are currently conducting and have fully enrolled the Phase IIb PLATEAU clinical trial, which is a double-blind, placebo-controlled study to evaluate the effect of enobosarm three milligrams on total body weight, fat mass, lean mass, physical function, bone mineral density, and safety in approximately 200 older patients age greater than or equal to 65 who have obesity with a BMI of greater than or equal to 35 and are initiating semaglutide Wegovy GLP-1 receptor agonist treatment for weight reduction. The primary efficacy endpoint of this study is the percent change from baseline in total body weight at 68 weeks. An interim analysis will be conducted at 32 weeks to assess the percent change from baseline in lean body mass and total fat mass as measured by DEXA scan.

Speaker #3: The primary efficacy endpoint of this study is the percent change from baseline in total body weight at 68 weeks, and an interim analysis will be conducted at 32 weeks to assess the percent change from baseline in lean body mass and total fat mass, as measured by DEXA scan.

Speaker #3: The key secondary endpoints for the overall study are total fat mass, total lean mass, physical function with the stair climb test, mobility disability assessment, bone mineral density, a patient-reported outcome questionnaire for physical function, HbA1c, and insulin resistance.

Mitchell Steiner: The key secondary endpoints for the overall study are total fat mass, total lean mass, physical function with the stair climb test, mobility disability assessment, bone mineral density, and a patient-reported outcome questionnaires for physical function, HbA1c, and insulin resistance. The objective of the Phase IIb PLATEAU clinical trial is to focus on the effects of longer-term GLP-1 receptor agonist treatment in older patients who have obesity. The Phase IIb PLATEAU clinical study will also assess the ability of enobosarm treatment to potentially break through the weight loss plateau observed in patients receiving a GLP-1 receptor agonist treatment to achieve a clinically meaningful incremental weight reduction as well as preserve muscle mass and physical function by 68 weeks. We recently announced we have completed full enrollment of the Phase IIb PLATEAU clinical trial with 239 patients enrolled.

Mitchell Steiner: The key secondary endpoints for the overall study are total fat mass, total lean mass, physical function with the stair climb test, mobility disability assessment, bone mineral density, and a patient-reported outcome questionnaires for physical function, HbA1c, and insulin resistance. The objective of the Phase IIb PLATEAU clinical trial is to focus on the effects of longer-term GLP-1 receptor agonist treatment in older patients who have obesity. The Phase IIb PLATEAU clinical study will also assess the ability of enobosarm treatment to potentially break through the weight loss plateau observed in patients receiving a GLP-1 receptor agonist treatment to achieve a clinically meaningful incremental weight reduction as well as preserve muscle mass and physical function by 68 weeks. We recently announced we have completed full enrollment of the Phase IIb PLATEAU clinical trial with 239 patients enrolled.

Speaker #3: The objective of the Phase 2b PLATEAU clinical trial is to focus on the effects of longer-term GLP-1 receptor agonist treatment in older patients who have obesity.

Speaker #3: The Phase 2b plateau clinical study will also assess the ability of a Novus arm treatment to potentially break through the weight loss plateau observed in patients receiving a GLP-1 receptor agonist treatment, to achieve a clinically meaningful incremental weight reduction, as well as preserve muscle mass and physical function by 68 weeks.

Speaker #3: We recently announced we have completed full enrollment of the Phase 2B PLATEAU clinical trial, with 239 patients enrolled. This puts us on track for a near-term milestone, which is to report the results of the 32-week interim analysis, expected in Q1 of calendar year 2027.

Mitchell Steiner: This puts us on track for a near-term milestone, which is reporting the results of the 32-week interim analysis, which is expected in Q1 2027. Semaglutide was selected as a GLP-1 receptor agonist for the Phase 2b PLATEAU study to build on Veru's previous clinical experience using enobosarm in combination with semaglutide in the positive Phase 2b QUALITY clinical study. Further, the clinical data from the Phase 2b PLATEAU clinical trial using injectable semaglutide may support the use of oral semaglutide and oral enobosarm fixed dose combination in future phase III clinical trials. The choice for selecting semaglutide was also a strategic one. On 2 June 2026, Veru entered into a supply agreement with Novo Nordisk for this Phase 2b PLATEAU clinical trial. In this agreement, Veru is solely responsible for conducting and sponsoring the Phase 2b PLATEAU clinical study.

Mitchell Steiner: This puts us on track for a near-term milestone, which is reporting the results of the 32-week interim analysis, which is expected in Q1 2027. Semaglutide was selected as a GLP-1 receptor agonist for the Phase 2b PLATEAU study to build on Veru's previous clinical experience using enobosarm in combination with semaglutide in the positive Phase 2b QUALITY clinical study. Further, the clinical data from the Phase 2b PLATEAU clinical trial using injectable semaglutide may support the use of oral semaglutide and oral enobosarm fixed dose combination in future phase III clinical trials. The choice for selecting semaglutide was also a strategic one. On 2 June 2026, Veru entered into a supply agreement with Novo Nordisk for this Phase 2b PLATEAU clinical trial. In this agreement, Veru is solely responsible for conducting and sponsoring the Phase 2b PLATEAU clinical study.

Speaker #3: Semaglutide was selected as a GLP-1 receptor agonist for the Phase 2b plateau study to build on VERU's previous clinical experience using a Novus arm in combination with semaglutide in the positive Phase 2b quality clinical study.

Speaker #3: Further, the clinical data from the Phase 2b PLATTEAU clinical trial using injectable semaglutide may support the use of oral semaglutide and oral Anovus ARM fixed-dose combination in future Phase 3 clinical trials.

Speaker #3: The choice of selecting semaglutide was also a strategic one. On June 2, 2026, VERU entered into a supply agreement with Novo Nordisk for this Phase 2B Plateau clinical trial.

Speaker #3: In this agreement, VERU is solely responsible for conducting and sponsoring the phase 2B plateau clinical study. Novo Nordisk will supply Wegovy to VERU at no charge and is required for the as required for the conduct of the phase 2B clinical study.

Mitchell Steiner: Novo Nordisk will supply Wegovy to Veru at no charge as required for the conduct of the phase IIb clinical study. Novo Nordisk provides Wegovy solely for the use within the study under the supply agreement. In return, Veru will provide Novo Nordisk with insights into obesity and weight management trial design, methodology, and clinical conduct, including regular clinical study updates, protocol changes, and safety updates. While Veru maintains full global development and commercialization rights to enobosarm, Veru has granted Novo Nordisk a right of first negotiation if Veru in the future intends to develop, commercialize, or license enobosarm intellectual property in combination with any Novo Nordisk GLP-1 product, including Wegovy for any indication. For further information, please see Veru's Form 8-K filed with the SEC on 4 June 2026.

Mitchell Steiner: Novo Nordisk will supply Wegovy to Veru at no charge as required for the conduct of the phase IIb clinical study. Novo Nordisk provides Wegovy solely for the use within the study under the supply agreement. In return, Veru will provide Novo Nordisk with insights into obesity and weight management trial design, methodology, and clinical conduct, including regular clinical study updates, protocol changes, and safety updates. While Veru maintains full global development and commercialization rights to enobosarm, Veru has granted Novo Nordisk a right of first negotiation if Veru in the future intends to develop, commercialize, or license enobosarm intellectual property in combination with any Novo Nordisk GLP-1 product, including Wegovy for any indication. For further information, please see Veru's Form 8-K filed with the SEC on 4 June 2026.

Speaker #3: Novo Nordisk provides Wegovy solely for use within the study under the supply agreement. In return, VERU will provide Novo Nordisk with insights into obesity and weight management trial design, methodology, and clinical conduct, including regular clinical study updates, protocol changes, and safety updates.

Speaker #3: While VERU maintains full global development and commercialization rights to a novus arm, VERU has granted Novo Nordisk a right of first negotiation if VERU in the future intends to develop, commercialize, or license a novus arm intellectual property in combination with any Novo Nordisk GLP-1 product, including Wegovy, for any indication.

Speaker #3: For further information, please see VERU's Form 8K filed with the SEC on June 4th, 2026. As for developments regarding a novus arm's intellectual property, the company recently announced that it had received from the United States Patent and Trademark Office a notice of allowance for key methods of use US patent application titled compositions, comprising selective angioreceptor modulator compounds in combination with weight loss drugs, and use thereof for quality weight loss.

Mitchell Steiner: As for developments regarding enobosarm's intellectual property, the company recently announced that it had received from the United States Patent and Trademark Office a notice of allowance for key methods of use, US patent application title, "Compositions Comprising Selective Androgen Receptor Modulator Compounds in Combination with Weight Loss Drugs and Use Thereof for Quality Weight Loss." The notice of allowance encompasses treatment regimens where, one, enobosarm is concurrently given with semaglutide, with the said co-therapy continuing. Two, enobosarm is added to initial semaglutide monotherapy with the said co-therapy continuing. Three, enobosarm continues or initiated after semaglutide therapy is discontinued. The allowed claims are directed to, one, preservation, restoration, and gaining of lean body mass and muscle mass. Two, enhancement of fat mass loss, including reducing abdominal, subcutaneous, or intramuscular fat accumulation to improve body composition and lower body fat content and lower fat mass.

Mitchell Steiner: As for developments regarding enobosarm's intellectual property, the company recently announced that it had received from the United States Patent and Trademark Office a notice of allowance for key methods of use, US patent application title, "Compositions Comprising Selective Androgen Receptor Modulator Compounds in Combination with Weight Loss Drugs and Use Thereof for Quality Weight Loss." The notice of allowance encompasses treatment regimens where, one, enobosarm is concurrently given with semaglutide, with the said co-therapy continuing. Two, enobosarm is added to initial semaglutide monotherapy with the said co-therapy continuing. Three, enobosarm continues or initiated after semaglutide therapy is discontinued. The allowed claims are directed to, one, preservation, restoration, and gaining of lean body mass and muscle mass. Two, enhancement of fat mass loss, including reducing abdominal, subcutaneous, or intramuscular fat accumulation to improve body composition and lower body fat content and lower fat mass.

Speaker #3: The notice of allowance encompasses treatment regimens where: 1) Novus arm is concurrently given with semaglutide, with the said cotherapy continuing; 2) the Novus arm is added to initial semaglutide monotherapy, with the said cotherapy continuing; and 3) the Novus arm continues or is initiated after semaglutide therapy is discontinued.

Speaker #3: The allowed claims are directed to: 1) preservation, restoration, or gaining of lean body mass or muscle mass; 2) enhancement of fat mass loss, including reducing abdominal subcutaneous or intramuscular fat accumulation, to improve body composition, lower body fat content, and lower fat mass; and 3) preservation, restoration, or improvement of physical function in the corresponding prevention and treatment of a number of conditions that can result from decreased physical function, such as reducing or treating muscle weakness or poor balance, decreased gait speed and mobility disability, loss of independence, increased risk of falls, loss of physical function, physical disability, poor quality of life, high hospitalization rates, and/or increased mortality.

Mitchell Steiner: Three, preservation, restoration, and improvement of physical function and the corresponding prevention and treatment of a number of conditions that can result from decreased physical function, such as reducing or treating muscle weakness or poor balance, decreased gait speed, mobility disability, loss of independence, increased risk of falls, loss of physical function, physical disability, poor quality of life, high hospitalization rates, and/or increased mortality. Four, preservation, restoration, or gaining of bone and a corresponding prevention and treatment of bone fractures. Five, overcoming and improving insulin resistance. Six, improving HbA1c. Seven, reduction or treatment to prevent total body gain rebound after discontinuing semaglutide. Eight, reduction of or treatment to prevent fat mass gain rebound after discontinuing semaglutide. Nine, treatment to prevent or restore lean mass loss during the rebound after discontinuing semaglutide.

Mitchell Steiner: Three, preservation, restoration, and improvement of physical function and the corresponding prevention and treatment of a number of conditions that can result from decreased physical function, such as reducing or treating muscle weakness or poor balance, decreased gait speed, mobility disability, loss of independence, increased risk of falls, loss of physical function, physical disability, poor quality of life, high hospitalization rates, and/or increased mortality. Four, preservation, restoration, or gaining of bone and a corresponding prevention and treatment of bone fractures. Five, overcoming and improving insulin resistance. Six, improving HbA1c. Seven, reduction or treatment to prevent total body gain rebound after discontinuing semaglutide. Eight, reduction of or treatment to prevent fat mass gain rebound after discontinuing semaglutide. Nine, treatment to prevent or restore lean mass loss during the rebound after discontinuing semaglutide.

Speaker #3: 4) preservation, restoration, or gaining of bone in the corresponding prevention and treatment of bone fractures; 5) overcoming and improving insulin resistance; 6) improving HbA1c; 7) reduction of, treatment, or prevention to prevent total body weight gain rebound after discontinuing semaglutide; 8) reduction of, or treatment to prevent, fat mass gain rebound after discontinuing semaglutide; and 9) treatment to prevent or restore lean mass loss during the rebound after discontinuing semaglutide.

Speaker #3: When issued, the US patent will have a patent expiry of at least October 3, 2044, prior to the potential application of any patent term adjustment or patent term extension.

Mitchell Steiner: When issued, the US patent will have a patent expiry of at least 03 October 2044, prior to the potential application of any patent term adjustment or patent term extension. These allowed claims add to the company's worldwide portfolio of patent applications directed to the method of use of enobosarm in combination with weight loss drugs for higher quality weight loss and incremental weight loss, including already issued enobosarm-specific polymorphic composition of matter patents, as well as a number of other patent uses of selective androgen receptor modulating compounds alone or in combination with weight loss drugs for quality weight loss and chronic weight management patient patent applications. The company continues to prosecute a number of pending patent applications worldwide, covering a number of different weight loss drugs beyond semaglutide.

Mitchell Steiner: When issued, the US patent will have a patent expiry of at least 03 October 2044, prior to the potential application of any patent term adjustment or patent term extension. These allowed claims add to the company's worldwide portfolio of patent applications directed to the method of use of enobosarm in combination with weight loss drugs for higher quality weight loss and incremental weight loss, including already issued enobosarm-specific polymorphic composition of matter patents, as well as a number of other patent uses of selective androgen receptor modulating compounds alone or in combination with weight loss drugs for quality weight loss and chronic weight management patient patent applications. The company continues to prosecute a number of pending patent applications worldwide, covering a number of different weight loss drugs beyond semaglutide.

Speaker #3: These allowed claims add to the company's worldwide portfolio of patent applications directed to the method of use of Enobosarm, in combination with weight loss drugs for higher quality weight loss and incremental weight loss. This includes already issued Enobosarm-specific polymorph composition of matter patents, as well as a number of other patent uses of selective androgen receptor modulator compounds alone, or in combination with weight loss drugs for quality weight loss and chronic weight management patient patent applications.

Speaker #3: The company continues to prosecute a number of patent-pending patent applications worldwide covering a number of different weight loss drugs beyond semaglutide. In addition, the patent portfolio of VERU includes patent applications directed to a novel oral modified release and novel zuranolone formulation, which, if such patents are issued, will provide patent protection until at least May 2046.

Mitchell Steiner: The patent portfolio of Veru includes patent applications directed to a novel oral modified release enobosarm formulation, which if such patent were to issue, would provide patent protection until at least May 2046. Now, Veru is targeting enobosarm for the at-risk older patients with sarcopenic obesity, which is a very large market. The prevalence of obesity in patients who are 65 years or older is 41.5% among the 47.4 million patients enrolled in Medicare Part D plans, which is about 20 million potential patients. Reimbursement for weight loss drugs continues to improve for patients over 65 years of age. According to medicare.gov, starting 01 July 2026, Medicare covers these GLP-1 drugs: Trulicity tablet, Wegovy injection or tablet, and Zepbound, the KwikPen only. I will now turn the call over to Michele Greco, CFO and COO, to discuss the financial highlights. Michele?

Mitchell Steiner: The patent portfolio of Veru includes patent applications directed to a novel oral modified release enobosarm formulation, which if such patent were to issue, would provide patent protection until at least May 2046. Now, Veru is targeting enobosarm for the at-risk older patients with sarcopenic obesity, which is a very large market. The prevalence of obesity in patients who are 65 years or older is 41.5% among the 47.4 million patients enrolled in Medicare Part D plans, which is about 20 million potential patients. Reimbursement for weight loss drugs continues to improve for patients over 65 years of age. According to medicare.gov, starting 01 July 2026, Medicare covers these GLP-1 drugs: Trulicity tablet, Wegovy injection or tablet, and Zepbound, the KwikPen only. I will now turn the call over to Michele Greco, CFO and CAO, to discuss the financial highlights. Michele?

Speaker #3: Now, VERU is targeting a new arm for at-risk older patients with sarcopenic obesity, which is a very large market. The prevalence of obesity in patients who are 65 years or older is 41.5% among the 47.4 million patients enrolled in the Medicare Part D plans, which is about 20 million potential patients.

Speaker #3: Reimbursement for weight loss drugs continues to improve for patients over 65 years of age, and according to Medicare.gov, starting July 1, 2026, Medicare covers these GLP drugs.

Speaker #3: Foundale tablet, Wegovy injection, and Zepbound, the quick pen only. I will now turn the call over to Michele Greco, CFO and CAO, to discuss the financial highlights.

Speaker #3: Michele?

Speaker #2: Thank you, Dr. Steiner. Let's review the results for the three months ended June 30, 2026. Research and development costs increased to $4.4 million from $3 million in the prior quarter.

Michele Greco: Thank you, Dr. Steiner. Let's review the results for the 3 months ended 30 June 2026. Research and development costs increased to $4.4 million from $3 million in the prior quarter. The increase is primarily due to the increased expenses related to the ongoing Phase IIb PLATEAU clinical study and the wind-down of the Phase IIb QUALITY clinical study for enobosarm, which was completed during fiscal 2025. This increase was partially offset by a decrease in personnel costs, primarily due to reduced share-based compensation expense. General and administrative expenses decreased to $3.4 million from $5 million in the prior quarter. The decrease is primarily due to a decrease in share-based compensation for corporate personnel and a reduction in third-party consulting expenses.

Michele Greco: Thank you, Dr. Steiner. Let's review the results for the 3 months ended 30 June 2026. Research and development costs increased to $4.4 million from $3 million in the prior quarter. The increase is primarily due to the increased expenses related to the ongoing Phase IIb PLATEAU clinical study and the wind-down of the Phase IIb QUALITY clinical study for enobosarm, which was completed during fiscal 2025. This increase was partially offset by a decrease in personnel costs, primarily due to reduced share-based compensation expense. General and administrative expenses decreased to $3.4 million from $5 million in the prior quarter. The decrease is primarily due to a decrease in share-based compensation for corporate personnel and a reduction in third-party consulting expenses.

Speaker #2: The increase is primarily due to the increased expenses related to the ongoing Phase 2B Plateau clinical study and the wind-down of the Phase 2B Quality clinical study for Enobosarm, which was completed during fiscal 2025.

Speaker #2: This increase was partially offset by a decrease in personnel costs, primarily due to reduced share-based compensation expense. General and administrative expenses decreased to $3.4 million from $5.0 million in the prior quarter.

Speaker #2: The decrease is primarily due to a decrease in share-based compensation for corporate personnel and a reduction in third-party consulting expenses. We recognized the gain on the sale of Enthalpy assets of $485,000 in the prior year's quarter, which is based on non-refundable consideration received related to promissory notes previously due to VERU.

Michele Greco: We recognized a gain on the sale of ENTADFI assets of $485,000 in the prior year's quarter, which is based on non-refundable consideration received related to promissory notes previously due to Veru. As the promissory notes are now settled, no additional gain is expected in future periods. During the prior fiscal year, the company entered into a settlement agreement with Onconetix, Inc., which included payment of Series D preferred stock and warrants. During the current period, the increase in the fair value of the equity securities received was $546,000 due to the realized gain from the conversion of the preferred stock and the sale of the underlying common stock, and the change in the fair value of the remaining warrants. Favorable antidilution provisions triggered by the Onconetix reverse stock split during the period contributed to the increase in the fair value.

Michele Greco: We recognized a gain on the sale of ENTADFI assets of $485,000 in the prior year's quarter, which is based on non-refundable consideration received related to promissory notes previously due to Veru. As the promissory notes are now settled, no additional gain is expected in future periods. During the prior fiscal year, the company entered into a settlement agreement with Onconetix, Inc., which included payment of Series D preferred stock and warrants. During the current period, the increase in the fair value of the equity securities received was $546,000 due to the realized gain from the conversion of the preferred stock and the sale of the underlying common stock, and the change in the fair value of the remaining warrants. Favorable antidilution provisions triggered by the Onconetix reverse stock split during the period contributed to the increase in the fair value.

Speaker #2: As the promissory notes are now settled, no additional gain is expected in future periods. During the prior fiscal year, the company entered into a settlement agreement with OnKinetics, Inc., which included payment of Series D preferred stock and warrants.

Speaker #2: During the current period, the increase in the fair value of the equity securities received was $546,000, due to the realized gain from the conversion of the preferred stock and the sale of the underlying common stock, and a change in the fair value of the remaining warrants.

Speaker #2: Favorable antidilution provisions triggered by the Onkinetics reverse stock split during the period contributed to the increase in the fair value. The net loss was $7.0 million, or $0.30 per diluted common share, compared to a net loss of $7.3 million, or $0.50 per diluted common share in the prior period.

Michele Greco: The net loss was $7 million for $0.30 per diluted common share, compared to a net loss of $7.3 million or $0.50 per diluted common share in the prior period. Turning to the nine months ended 30 June 2026. Research and development costs decreased to $8.8 million from $12.7 million in the prior period. The decrease is primarily due to wind down of the Phase 2b QUALITY clinical study for enobosarm, which was completed during fiscal 2025. Personnel costs also decreased due primarily to the reduced share-based compensation expense. General administrative expenses decreased to $11.5 million from $15.4 million in the prior period. The decrease is primarily due to a decrease in share-based compensation for corporate personnel and a reduction in third-party consulting expenses.

Michele Greco: The net loss was $7 million for $0.30 per diluted common share, compared to a net loss of $7.3 million or $0.50 per diluted common share in the prior period. Turning to the nine months ended 30 June 2026. Research and development costs decreased to $8.8 million from $12.7 million in the prior period. The decrease is primarily due to wind down of the Phase 2b QUALITY clinical study for enobosarm, which was completed during fiscal 2025. Personnel costs also decreased due primarily to the reduced share-based compensation expense. General administrative expenses decreased to $11.5 million from $15.4 million in the prior period. The decrease is primarily due to a decrease in share-based compensation for corporate personnel and a reduction in third-party consulting expenses.

Speaker #2: Now, turning to the nine months ended June 30, 2026. Research and development costs decreased to $8.8 million from $12.7 million in the prior period.

Speaker #2: The decrease is primarily due to the wind-down of the Phase 2b quality clinical study for the Novus arm, which was completed during fiscal 2025. Personnel costs also decreased, due primarily to the reduced share-based compensation expense.

Speaker #2: General administrative expenses decreased to $11.5 million from $15.4 million in the prior period. The decrease is primarily due to a reduction in share-based compensation for corporate personnel and a reduction in third-party consulting expenses.

Speaker #2: We recognized the gain on the sale of enthalpy assets of $2.2 million in the prior period. In conjunction with the sale of the FC2 Female Condom business during the prior fiscal year, we recorded a gain on extinguishment of debt of $8.6 million related to the termination of the SWK Holdings residual royalty agreement.

Michele Greco: We recognized a gain on the sale of ENTADFI assets of $2.2 million in the prior period. In conjunction with the sale of the FC2 Female Condom business during the prior fiscal year, we recorded a gain on extinguishment of debt of $8.6 million related to the termination of the SWK Holdings residual royalty agreement. During the period, the company recorded a gain of $4.4 million from the increase in the fair value of Onconetix equity securities compared to a loss from the decrease in fair value of Onconetix equity securities of $0.3 million in the prior period.

Michele Greco: We recognized a gain on the sale of ENTADFI assets of $2.2 million in the prior period. In conjunction with the sale of the FC2 Female Condom business during the prior fiscal year, we recorded a gain on extinguishment of debt of $8.6 million related to the termination of the SWK Holdings residual royalty agreement. During the period, the company recorded a gain of $4.4 million from the increase in the fair value of Onconetix equity securities compared to a loss from the decrease in fair value of Onconetix equity securities of $0.3 million in the prior period.

Speaker #2: During the period, the company recorded a gain of $4.4 million from the increase in the fair value of Onkinetics equity securities, compared to a loss from the decrease in fair value of Onkinetics equity securities of $0.3 million in the prior period.

Speaker #2: The increase in fair value of the equity securities during the current period is the result of a realized gain from the conversion of the Onkinetics preferred stock and the sale of the underlying common stock, as well as a change in the fair value of the remaining warrants.

Michele Greco: The increase in fair value of the equity securities during the current period is the result of a realized gain from the conversion of the Onconetix preferred stock and the sale of the underlying common stock, and a change in the fair value of the remaining warrants. Favorable antidilution provisions triggered by the Onconetix reverse stock split during the period contributed to the increase in fair value. During the period, the company recognized an additional gain on sale of the FC2 business of $351,000 for the net proceeds received from Clear Future in the settlement of a dispute related to a pre-closing tax receivable and liability, which resulted in income from discontinued operations.

Michele Greco: The increase in fair value of the equity securities during the current period is the result of a realized gain from the conversion of the Onconetix preferred stock and the sale of the underlying common stock, and a change in the fair value of the remaining warrants. Favorable antidilution provisions triggered by the Onconetix reverse stock split during the period contributed to the increase in fair value. During the period, the company recognized an additional gain on sale of the FC2 business of $351,000 for the net proceeds received from Clear Future in the settlement of a dispute related to a pre-closing tax receivable and liability, which resulted in income from discontinued operations.

Speaker #2: Favorable antidilution provisions triggered by the Onkinetics reverse stock split during the period contributed to the increase in fair value. During the period, the company recognized an additional gain on sale of the FC2 business of $351,000 for the net proceeds received from Clear Future in the settlement of a dispute related to a pre-closing tax receivable and liability, which resulted in income from discontinued operations.

Speaker #2: In the prior period, there was a net loss from discontinued operations of $7.2 million, which relates to the operations of the FC2 business during the period and the loss on the sale of the business.

Michele Greco: In the prior period, there was a net loss from discontinued operations of $7.2 million, which relates to the operations of the FC2 business during the period and the loss on the sale of the business. The net loss was $15.1 million, or $0.68 per diluted common share, compared to a net loss of $24.2 million or $1.65 per diluted common share in the prior period. Looking at the balance sheet. As of 30 June 2026, our cash equivalents, and restricted cash balance was $23.9 million compared to $15.8 million as of 30 September 2025. On both 30 June 2026 and 30 September 2025, there was $54,000 of restricted cash related to the sale of the FC2 Female Condom business.

Michele Greco: In the prior period, there was a net loss from discontinued operations of $7.2 million, which relates to the operations of the FC2 business during the period and the loss on the sale of the business. The net loss was $15.1 million, or $0.68 per diluted common share, compared to a net loss of $24.2 million or $1.65 per diluted common share in the prior period. Looking at the balance sheet. As of 30 June 2026, our cash equivalents, and restricted cash balance was $23.9 million compared to $15.8 million as of 30 September 2025. On both 30 June 2026 and 30 September 2025, there was $54,000 of restricted cash related to the sale of the FC2 Female Condom business.

Speaker #2: The net loss was 15.1 million dollars or 68 cents per diluted common share, compared to a net loss of 24.2 million dollars or 1 dollar and 65 cents per diluted common share in the prior period.

Speaker #2: Looking at the balance sheet, as of June 30, 2026, our cash, cash equivalents, and restricted cash balance was $23.9 million, compared to $15.8 million as of September 30, 2025.

Speaker #2: On both June 30, 2026, and September 30, 2025, there was $54,000 of restricted cash related to the sale of the FC2 female condom business.

Speaker #2: Our net working capital was $21.1 million as of June 30, 2026, compared to $11.1 million as of September 30, 2025. The company has not been profitable and has had negative cash flow from operations.

Michele Greco: Our net working capital was $21.1 million on 30 June 2026 compared to $11.1 million on 30 September 2025. The company is not profitable and has had negative cash flow from operations. Based upon the company's current operating plan, our cash, as of the issuance date of these financial statements, is expected to be sufficient for the company to fund operations beyond the interim analysis in the Phase IIb PLATEAU clinical study. During the 9 months ended 30 June 2026, we used cash of $20.6 million for operating activities, compared with $24.6 million used for operating activities in the prior period. We generated cash from investing activities of $5.3 million for the 9 months ended 30 June 2026 compared to $18.9 million in the prior period.

Michele Greco: Our net working capital was $21.1 million on 30 June 2026 compared to $11.1 million on 30 September 2025. The company is not profitable and has had negative cash flow from operations. Based upon the company's current operating plan, our cash, as of the issuance date of these financial statements, is expected to be sufficient for the company to fund operations beyond the interim analysis in the Phase IIb PLATEAU clinical study. During the 9 months ended 30 June 2026, we used cash of $20.6 million for operating activities, compared with $24.6 million used for operating activities in the prior period. We generated cash from investing activities of $5.3 million for the 9 months ended 30 June 2026 compared to $18.9 million in the prior period.

Speaker #2: Based upon the company's current operating plan, our cash, as of the issuance date of these financial statements, is expected to be sufficient for the company to fund operations beyond the interim analysis in the Phase 2b Plateau clinical study.

Speaker #2: During the nine months ended June 30, 2026, we used cash of $20.6 million for operating activities, compared with $24.6 million used for operating activities in the prior period.

Speaker #2: We generated cash from investing activities of $5.3 million for the nine months ended June 30, 2026, compared to $18.9 million in the prior period.

Speaker #2: The cash generated in the current period represents proceeds from the sale of Onkinetics equity securities of $5 million and $0.4 million for the settlement of a dispute related to pre-closing tax matters related to the sale of the FC2 business.

Michele Greco: The cash generated in the current period represents proceeds from the sale of Onconetix equity securities of $5 million and $0.4 million for the settlement of a dispute related to pre-closing tax matters related to the sale of the FC2 business. The cash generated in the prior period relates to proceeds from the sale of the FC2 Female Condom business of $16.3 million, proceeds of $2.2 million from the sale of the ENTADFI assets, and proceeds of $0.4 million from the sale of equity securities. Net cash provided by financing activities through the 9 months ended 30 June 2026 was $23.3 million, which was the proceeds from the underwritten public offering net of commissions and costs.

Michele Greco: The cash generated in the current period represents proceeds from the sale of Onconetix equity securities of $5 million and $0.4 million for the settlement of a dispute related to pre-closing tax matters related to the sale of the FC2 business. The cash generated in the prior period relates to proceeds from the sale of the FC2 Female Condom business of $16.3 million, proceeds of $2.2 million from the sale of the ENTADFI assets, and proceeds of $0.4 million from the sale of equity securities. Net cash provided by financing activities through the 9 months ended 30 June 2026 was $23.3 million, which was the proceeds from the underwritten public offering net of commissions and costs.

Speaker #2: The cash generated in the prior period relates to proceeds from the sale of the FC2 female condom business of $16.3 million, proceeds of $2.2 million from the sale of the enthalpy assets, and proceeds of $0.4 million from the sale of equity securities.

Speaker #2: Net cash provided by financing activities for the nine months ended June 30, 2026, was $23.3 million, which was the proceeds from the underwritten public offering, net of commissions and costs.

Speaker #2: We used cash in financing activities for the nine months ended June 30, 2025, of $4.2 million related to the change of control payment to SWK pursuant to the residual royalty agreement, which terminated in conjunction with the sale of the FC2 female condom business.

Michele Greco: We used cash and financing activities for the 9 months ended 30 June 2025 of $4.2 million related to the change-of-control payment to SWK pursuant to the residual royalty agreement, which terminated in conjunction with the sale of the FC2 Female Condom business. I'd like to turn the call back to Dr. Steiner. Dr. Steiner?

Michele Greco: We used cash and financing activities for the 9 months ended 30 June 2025 of $4.2 million related to the change-of-control payment to SWK pursuant to the residual royalty agreement, which terminated in conjunction with the sale of the FC2 Female Condom business. 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 Dr. Steiner. Dr. Steiner?

Speaker #3: Thank you. With that, I'll now open the call to questions. Operator?

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

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

Speaker #4: 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.

Operator 2: 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

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

Speaker #4: 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.

Speaker #4: 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.

Operator 2: 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 one to rejoin the question queue. We will pause momentarily to assemble our roster. Our first question comes from Leland Gershell with Oppenheimer. Please go ahead.

Operator: 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 one to rejoin the question queue. We will pause momentarily to assemble our roster. Our first question comes from Leland Gershell with Oppenheimer. Please go ahead.

Speaker #4: Once again, that is star one to rejoin the question queue. We will pause momentarily to assemble our roster. Our first question comes from Leland Gershall with Oppenheimer.

Speaker #4: Please go ahead.

Speaker #5: Thanks. Great. Good morning, Mitch and team. Glad to hear all the progress with the plateau study and so forth. Just a question from us on the IP: the new patent on the use of an Opus ARM in combination with an Opus ARM.

Leland Gershell: Thanks. Great. Good morning, Mitch and team, glad to hear all the progress with the PLATEAU study and so forth. Just a question from us on the IP, the new patent on the use of enobosarm in combination with semaglutide. As the GLP-1 class broadens and delivery modes expand with the orals, as you'd mentioned, Fontnio, and other GLP-1 plus other mechanisms being incorporated in the same medication, just wondering about the ability for you to broaden that patent or have additional IP that could cover other agents as they come along, given that people will likely look to use enobosarm should it be approved with those other agents. Thank you.

Leland Gershell: Thanks. Great. Good morning, Mitch and team, glad to hear all the progress with the PLATEAU study and so forth. Just a question from us on the IP, the new patent on the use of enobosarm in combination with semaglutide. As the GLP-1 class broadens and delivery modes expand with the orals, as you'd mentioned, Fontnio, and other GLP-1 plus other mechanisms being incorporated in the same medication, just wondering about the ability for you to broaden that patent or have additional IP that could cover other agents as they come along, given that people will likely look to use enobosarm should it be approved with those other agents. Thank you.

Speaker #5: Just wondering—obviously, that reflects, of course, your development of the compound in the trials. But as the GLP-1 class broadens and delivery modes expand, with now the orals, as you had mentioned, Vandeo, and other GLP-1 plus other mechanisms being incorporated into the same medication.

Speaker #5: Just wondering about the ability for you to broaden that patent or have additional IP that could cover other agents as they come along, given that people will likely look to use an Opus arm, should it be approved, with those other agents.

Speaker #5: Thank you.

Speaker #3: Yeah. So, first of all, great question. So the first question is: why is this patent so significant for our company? And then the second, what does it mean for the other things that we're prosecuting at this point?

Mitchell Steiner: Yeah. First of all, it's a great question. The first question is, why is this patent so significant for our company? The second, what does it mean for the other things that we're prosecuting at this point? The first part is, enobosarm in combination with semaglutide is a brand new combination of a weight loss drug. It was a brand new concept. The weight loss drugs took us by storm, and we immediately found out that with the weight loss drugs, we had to have a situation where you lost lean and lost physical function. In comes enobosarm. The first part was to elbow our way in to make sure that we had a method of use path going forward, in combination with enobosarm, or with enobosarm being given after a patient stops their GLP-1 because they want to be rescued.

Mitchell Steiner: Yeah. First of all, it's a great question. The first question is, why is this patent so significant for our company? The second, what does it mean for the other things that we're prosecuting at this point? The first part is, enobosarm in combination with semaglutide is a brand new combination of a weight loss drug. It was a brand new concept. The weight loss drugs took us by storm, and we immediately found out that with the weight loss drugs, we had to have a situation where you lost lean and lost physical function. In comes enobosarm. The first part was to elbow our way in to make sure that we had a method of use path going forward, in combination with enobosarm, or with enobosarm being given after a patient stops their GLP-1 because they want to be rescued.

Speaker #3: So the first part is, an Opustarm in combination with semaglutide is a brand new combination with a weight loss drug. It was a brand new concept.

Speaker #3: The weight loss drugs took us by storm, and we immediately found out that with the weight loss drugs, we ended up in a situation where you lost lean and lost physical function, and comes an opus arm.

Speaker #3: So the first part was to elbow our way in to make sure that we had a method-of-use path going forward, in combination with an Opus arm, or with an Opus arm being given after a patient stops the GLP-1 because they want to be rescued.

Speaker #3: And so, we were very, very broad in the patent applications to include all weight loss drugs. If you look at the title of the application, the title of the application says 'weight loss drugs.'

Mitchell Steiner: We're very broad in the patent applications to include all weight loss drugs. If you look at the title of the application, the title of the application says weight loss drugs. This is a one-two punch. The first punch is to get out there and show we can put a stake in the ground and get it, and that's why this is so significant. We got a wonderful notice of allowance with semaglutide, with all of the features that you would want to protect enobosarm in combination with semaglutide, whether it's oral or not, in whatever form and whatever relates to body composition, and whether you give it with semaglutide or before, or if somebody's already on semaglutide, somebody stops semaglutide. These are all things that we just didn't know from a patent protection standpoint we would get. We did.

Mitchell Steiner: We're very broad in the patent applications to include all weight loss drugs. If you look at the title of the application, the title of the application says weight loss drugs. This is a one-two punch. The first punch is to get out there and show we can put a stake in the ground and get it, and that's why this is so significant. We got a wonderful notice of allowance with semaglutide, with all of the features that you would want to protect enobosarm in combination with semaglutide, whether it's oral or not, in whatever form and whatever relates to body composition, and whether you give it with semaglutide or before, or if somebody's already on semaglutide, somebody stops semaglutide. These are all things that we just didn't know from a patent protection standpoint we would get. We did.

Speaker #3: But this is a one-two punch. The first punch is to get out there and show we can put a stake in the ground and get it, and that's why this is so significant.

Speaker #3: We got a wonderful notice of allowance with semaglutide, with all of the features that you would want to protect an Opus arm in combination with semaglutide—its oral allowance, whatever form, and whatever related to body composition—and whether you give it with semaglutide, to, or before, or with somebody who's already on semaglutide, and somebody stopped semaglutide.

Speaker #3: These are all things that we just didn't know, from a patent protection standpoint, we would get. We did. And there's no surprise that we have patent applications pending for the whole weight loss class beyond GLP-1s.

Mitchell Steiner: It's no surprise that we have patent applications pending for the whole weight loss class, and beyond GLP-1s. It's not just GLP-1. It takes time to prosecute patents, but this is the first major break to show that, who thought that enobosarm in combination with a weight loss drug would have these kinds of effects? The patent office clearly sees this as novel and not obvious. That's a big breakthrough for us. Stay tuned as we get our patent portfolio more mature. This is a big break because this is the first time we were able to pick up this whole area. From a commercial standpoint, now you have a patent in a major market, and you're just waiting for the additional patent to make their way through the system. Yes, the idea is to broadly use.

Mitchell Steiner: It's no surprise that we have patent applications pending for the whole weight loss class, and beyond GLP-1s. It's not just GLP-1. It takes time to prosecute patents, but this is the first major break to show that, who thought that enobosarm in combination with a weight loss drug would have these kinds of effects? The patent office clearly sees this as novel and not obvious. That's a big breakthrough for us. Stay tuned as we get our patent portfolio more mature. This is a big break because this is the first time we were able to pick up this whole area. From a commercial standpoint, now you have a patent in a major market, and you're just waiting for the additional patent to make their way through the system. Yes, the idea is to broadly use.

Speaker #3: And so it's not just GLP-1s. It takes time to prosecute patents, but this is the first major break to show that, who thought that an Opus arm in combination with a weight loss drug would have these kinds of effects? And the patent office clearly sees this as novel and not obvious.

Speaker #3: And so, that's a big breakthrough for us. So, stay tuned as we get our patent portfolio more mature. But this is a big, big break, because this is the first time we're able to pick up this whole area, and from a commercial standpoint, now you have a patent in a major market and you're just waiting for the additional patents to make their way through the system.

Speaker #3: So, yes, the idea is to broadly use it, but with that said, as you mentioned, our clinical developments with semaglutide at this point—and to have that all covered initially—is important for the company.

Mitchell Steiner: With that said, as you said, our clinical development of semaglutide at this point and to have that all covered initially is important for the company, and that's why I'm happy semaglutide one came first, because we're doing semaglutide in our clinical development program at this point. Does that make sense?

Mitchell Steiner: With that said, as you said, our clinical development of semaglutide at this point and to have that all covered initially is important for the company, and that's why I'm happy semaglutide one came first, because we're doing semaglutide in our clinical development program at this point. Does that make sense?

Speaker #3: And that's why I'm happy semaglutide one came first because we're doing semaglutide in our clinical development program at this point. Does that make sense?

Speaker #5: Yeah, that's great. Thanks so much. It's very helpful.

Leland Gershell: Yeah, that's great. Thanks so much. That's very helpful.

Leland Gershell: Yeah, that's great. Thanks so much. That's very helpful.

Speaker #3: Okay. In fact, as I think about it, I think the patents one quarter that we should pay attention to and take notice. So for example, when we first started out, the idea was you would try to preserve muscle and burn more fat for all patients.

Mitchell Steiner: Yeah. In fact, as I think about it, I think the patent's one of many things that happened this quarter that we should pay attention to and take notice. For example, when we first started out, the idea was you would try to preserve muscle and burn more fat for all patients. Remember, we were the company with our previous experience in frailty and cancer wasting, saying that the older patients would be more at risk. That's what's happening. The field is moving in our direction with people saying, younger patients, we're not quite sure what it means with its non-selective weight loss, but everybody agrees that in older patients it's a problem.

Mitchell Steiner: Yeah. In fact, as I think about it, I think the patent's one of many things that happened this quarter that we should pay attention to and take notice. For example, when we first started out, the idea was you would try to preserve muscle and burn more fat for all patients. Remember, we were the company with our previous experience in frailty and cancer wasting, saying that the older patients would be more at risk. That's what's happening. The field is moving in our direction with people saying, younger patients, we're not quite sure what it means with its non-selective weight loss, but everybody agrees that in older patients it's a problem.

Speaker #3: And remember, we were the company with our previous experience in frailty and cancer wasting, saying that the older patients would be more at risk.

Speaker #3: And that's what's happening. The field is moving in our direction, but people are saying, 'Younger patients—we're not quite sure what it means.' But it's non-selective weight loss, but everybody agrees that in older patients it's a problem.

Speaker #3: And of course we have data that we presented that shows that you have a 45% decline in greater than 10% stair climb power in patients on a GLP-1 alone if you're over the age of 60.

Mitchell Steiner: Of course, we have data that we've presented that shows that you have a 45% decline in greater than 10% stair climb power in patients on a GLP-1 alone if you're over the age of 60. It's a real problem. We're seeing the field kind of move in our direction, which is important because, at the end of the day, when you have a commercial product, you have to have a commercial product for a specific population. The specific population is now being defined by the clinical trials that we're doing. You can almost see what a label will look like. You're not going to have a situation where you're going to give a drug like this to everybody all the time.

Mitchell Steiner: Of course, we have data that we've presented that shows that you have a 45% decline in greater than 10% stair climb power in patients on a GLP-1 alone if you're over the age of 60. It's a real problem. We're seeing the field kind of move in our direction, which is important because, at the end of the day, when you have a commercial product, you have to have a commercial product for a specific population. The specific population is now being defined by the clinical trials that we're doing. You can almost see what a label will look like. You're not going to have a situation where you're going to give a drug like this to everybody all the time.

Speaker #3: So it's a real problem. And so we're seeing the field kind of move in our direction which is important. Because at the end of the day when you have a commercial product, you have to have a commercial product for a specific population and so the specific population is now being defined by the clinical trials that we're doing.

Speaker #3: So you can almost see what a label would look like. I mean, you're not going to have a situation where you're going to give a drug like this to everybody all the time.

Speaker #3: The FDA wants you to pick a patient population and that's what we're spending a lot of time defining. Now with that said, not only is the indication coming in our direction but also we have a near-term milestones now by having the trial completed enrolled at 239 patients in our first milestone coming up is Q1, 2027.

Mitchell Steiner: The FDA wants you to pick a patient population, that's what we're spending a lot of time defining. Now, with that said, not only is the indication coming our direction, but also we have near-term milestones now. By having the trial completely enrolled with 239 patients, our first milestone coming up is Q1 2027. We'll have the interim look. By the way, by Q4 2027, we'll have the final data. This has gone from, Oh, we're not going to have news, to, We've got news coming up pretty soon. This is important. Another thing that you have to take notice is we now have a clinical supply agreement with Novo Nordisk, which is a direct channel into the Novo Nordisk conglomerate, I guess, is the best way to say it. As you know, there's two big players.

Mitchell Steiner: The FDA wants you to pick a patient population, that's what we're spending a lot of time defining. Now, with that said, not only is the indication coming our direction, but also we have near-term milestones now. By having the trial completely enrolled with 239 patients, our first milestone coming up is Q1 2027. We'll have the interim look. By the way, by Q4 2027, we'll have the final data. This has gone from, Oh, we're not going to have news, to, We've got news coming up pretty soon. This is important. Another thing that you have to take notice is we now have a clinical supply agreement with Novo Nordisk, which is a direct channel into the Novo Nordisk conglomerate, I guess, is the best way to say it. As you know, there's two big players.

Speaker #3: We will have the interim look and, by the way, by Q4 2027, we'll have the final data. So this has gone from, "Oh, they're not going to have news" to "We've got news coming up pretty soon, and this is important."

Speaker #3: Another thing that you have to take note of—you just have to take notice—is we now have a clinical supply agreement with Novo Nordisk, which is a direct channel into the Novo Nordisk conglomerate, I guess is the best way to say it.

Speaker #3: And as you know, there's two big players. There's Lilly and Novo and everybody else is trying to get into the space and right now Novo and Lilly have staked out 15% weight loss to all weight to 28% weight loss with their pills or their injectables.

Mitchell Steiner: There's Lilly and Novo, everybody else is trying to get into the space. Right now, Novo and Lilly have staked out 15% weight loss all the way to 28% weight loss with their pills or their injectables. Anybody else coming in, the 80 companies or so that are developing, if they do less than 15% weight loss, they're dead in the water. If they're greater than 28%, that's great. If they're between 15% and 28%, they're not adding anything to what's already available commercially by Novo and Lilly. You have to have something else. Something else is where enobosarm comes in, because if you can make the weight loss between 15% and 28%, 100% fat and preserve muscle and improve physical function, then that can be interesting.

Mitchell Steiner: There's Lilly and Novo, everybody else is trying to get into the space. Right now, Novo and Lilly have staked out 15% weight loss all the way to 28% weight loss with their pills or their injectables. Anybody else coming in, the 80 companies or so that are developing, if they do less than 15% weight loss, they're dead in the water. If they're greater than 28%, that's great. If they're between 15% and 28%, they're not adding anything to what's already available commercially by Novo and Lilly. You have to have something else. Something else is where enobosarm comes in, because if you can make the weight loss between 15% and 28%, 100% fat and preserve muscle and improve physical function, then that can be interesting.

Speaker #3: And anybody else coming in, the 80 companies or so, that are developing have to do they do less than 15% weight loss. They're dead in the water and they're between if they're greater than 28%, that's great.

Speaker #3: But if they're between 15 and 28%, they're not adding anything to what's already available commercially by Novo and Lilly. So you have to have something else and something else is where an opus arm comes in because if you can make the weight loss between 15% and 28% fat 100% fat and preserve muscle and improve physical function, then that could be interesting.

Speaker #3: And finally, as we mentioned next as we mentioned in this previously in this answer to your question, it's a big deal that we picked up a patent method of use patent in this space and it allows us to put a stake in the ground for an opus arm where the patent office considers it novel and non-obvious and it allows our patent portfolio to go to 2044 just this asset.

Mitchell Steiner: Finally, as we mentioned previously in this answer to your question, it's a big deal that we picked up a method of use patent in this space and it allows to put a stake in the ground for enobosarm, where the patent office considers it novel and non-obvious and allows our patent portfolio to go to 2044 with just this asset, with this patent. 2044 is a long time, and again, we're very excited about that development. The market's still massive. People said, "Why are you slicing the market?" It's a massive market. As I said in my prepared comments, 41.5% of the 47.4 million people on Part D of Medicare. Part D is the oral part, and if you buy the drug in a pharmacy. I guess injectables will fall in that same category if you buy it from a pharmacy. That's 20 million+ people.

Mitchell Steiner: Finally, as we mentioned previously in this answer to your question, it's a big deal that we picked up a method of use patent in this space and it allows to put a stake in the ground for enobosarm, where the patent office considers it novel and non-obvious and allows our patent portfolio to go to 2044 with just this asset, with this patent. 2044 is a long time, and again, we're very excited about that development. The market's still massive. People said, "Why are you slicing the market?" It's a massive market. As I said in my prepared comments, 41.5% of the 47.4 million people on Part D of Medicare. Part D is the oral part, and if you buy the drug in a pharmacy. I guess injectables will fall in that same category if you buy it from a pharmacy. That's 20 million+ people.

Speaker #3: With this patent, so 2044 is a long time and again, we're very, very excited about that development. The market's still massive. People say, "Why are you slicing the market?" It's a massive market.

Speaker #3: As I said in my prepared comments, 41.5% of the 47.4 million people in Medicare Part D is the oral part.

Speaker #3: And if you buy the drug in a pharmacy, and I guess injectables will fall in that same category if you buy it from a pharmacy.

Speaker #3: In that's 20 million plus people. And Medicare is moving in a direction now. They're paying for the weight loss drugs and so if we had a drug that preserves physical function and does the things that we're showing in the opus arm can do, we would be in the same category and it should be it should be something that Medicare would want to pay for.

Mitchell Steiner: Medicare is moving in a direction now. They're paying for the weight loss drugs. If we had a drug that preserves physical function and does the things that we're showing enobosarm can do, we would be in the same category, and it should be something that Medicare would want to pay for. The big move is they've now swung in a direction to pay for obesity drugs, which is a big deal. A lot of things happening and to take notice, and we're head of the pack at this point. We're highly focused on what is that commercial population that we need to understand the best benefit initially for enobosarm in combination with a GLP-1.

Mitchell Steiner: Medicare is moving in a direction now. They're paying for the weight loss drugs. If we had a drug that preserves physical function and does the things that we're showing enobosarm can do, we would be in the same category, and it should be something that Medicare would want to pay for. The big move is they've now swung in a direction to pay for obesity drugs, which is a big deal. A lot of things happening and to take notice, and we're head of the pack at this point. We're highly focused on what is that commercial population that we need to understand the best benefit initially for enobosarm in combination with a GLP-1.

Speaker #3: So the big move is they've now swung in a direction to pay for obesity drugs, which is a big deal. So a lot of things happening and to take notice, and we're headed to PAC at this point.

Speaker #3: And we're highly focused on understanding what that commercial population is that we need to best benefit initially for an Opus arm in combination with a GLP-1.

Speaker #1: Thank you.

[Analyst]: Thank you.

Leland Gershell: Thank you.

Speaker #2: Ladies and gentlemen, this concludes our question-and-answer session. I would like to turn the conference back over to Dr. Mitchell Steiner for any closing remarks.

Operator 2: Ladies and gentlemen, this concludes our question and answer session. I would like to turn the conference 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 conference back over to Dr. Mitchell Steiner for any closing remarks.

Speaker #3: Thank you, operator. I appreciate everybody who joined us on today's call and I look forward to updating all of you on our progress in our next investors call.

Mitchell Steiner: Thank you, operator. I appreciate everybody who joined us on today's call, and I look forward to updating all of you on our progress in our next investors call. Thank you again.

Mitchell Steiner: Thank you, operator. I appreciate everybody who joined us on today's call, and I look forward to updating all of you on our progress in our next investors call. Thank you again.

Speaker #3: Thank you again.

Speaker #2: The digital replay of the conference call will be available beginning at approximately 12:00 p.m. Eastern Time today, August 10th, by dialing 1-855-669-9658 in the U.S. and 1-412-317-0088 internationally.

Operator 2: The digital replay of the conference call will be available beginning approximately 12:00 PM Eastern Time today, 10 August, 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 2565519. Please record your name and company when joining. The conference call has now concluded. Thank you for attending today's discussion.

Operator: The digital replay of the conference call will be available beginning approximately 12:00 PM Eastern Time today, 10 August, 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 2565519. Please record your name and company when joining. The conference call has now concluded. Thank you for attending today's discussion.

Speaker #2: You will be prompted to enter the replay access code. Which will be 2565519. Please record your name and company when joining. The conference call has now concluded.

Q3 2026 Veru Inc Earnings Call

Demo
VERU

Veru

Earnings

Q3 2026 Veru Inc Earnings Call

VERU

Monday, August 10th, 2026 at 12:00 PM

Transcript

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