VERU

Image source: The Motley Fool. Monday, Aug. 10, 2026 at 8:00 a.m. ET Chairman, CEO and President - Mitchell Steiner Chief Financial Officer and Chief Administrative Officer - Michele Greco Chief Scientific Officer - Gary Barnette General Counsel - Phil Greenberg Executive Director, Investor Relations and Corporate Communications - Samuel Fisch Operator: Good morning, ladies and gentlemen, and welcome to Veru Inc.'s Investors Conference Call. [Operator Instructions] 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. Samuel 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. 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 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. Our drug development program consists of two novel small molecules: enobosarm and sabizabulin. 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 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 of fiscal 2026 third quarter ended June 30, 2026. GLP-1s have been known 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 drug should be a combination therapy with GLP-1 receptor agonists to cause patients who only lose fat while preserving lean mass and 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. 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. In muscle, mass loss -- as muscle mass loss alone does not define sarcopenia, we chose to objectively evaluate and measure physical function by stair climb test, which is a common activity of daily living. Veru completed the Phase IIb quality clinical study, which was a multicenter, 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. As we noted, that the Phase IIb QUALITY clinical trial was the first human study to demonstrate that weight reduction in the 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 have 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 IIb 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 and at risk older patients with sarcopenic obesity receiving a GLP-1 receptor agonist for weight reduction. Now a common and serious clinical and therapeutic challenge with GLP-1 receptor agonist treatments is that 88% of patients after 1 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 & Company, 62.6% of these patients unfortunately still had clinical obesity at the time they reach this weight loss plateau of 1 year. One explanation might be that the non-selective loss of muscle caused by weight loss may have reached a point that now stimulates appetite in patients receiving a GLP-1 receptor agonist where they consume more calories, which in turn may cause patients to stop losing weight and hit their weight loss plateau. 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 should burn even more calories thus retaining muscle, and appetite stays suppressed while more calories are burned, which could help to break through the weight loss plateau, leading to incremental weight reduction. 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 3 milligrams on total body weight, fat mass, lean mass, physical function, bone mineral density and safety in approximately 200 older patients age greater or equal to 65 who have obesity with a BMI greater or equal to 35 and are initiating semaglutide, Wegovy, GLP-1 receptor agonist treatment for weight reduction. The primary efficacy endpoint of the study is the percent change from baseline in total body weight at 68 weeks, and interim analysis will be conducted at 32 weeks to assess the percent change in baseline lean body mass and total fat mass as measured by DEXA scan. 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 questionnaire on physical function, HbA1c and insulin resistance. The objective of the Phase IIb PLATEAU clinical trial is a 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 GLP-1 receptor agonist treatment to achieve a clinically meaningful incremental weight reduction as well as reserve 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. This puts us on track for a near-term milestone, which is reporting the results of the 32-week inter-analysis which is expected in Q1 calendar year 2027. Semaglutide was selected as a GLP-1 receptor agonist for the Phase IIb PLATEAU study to build on Veru's previous clinical experience using enobosarm in combination with semaglutide in the positive Phase IIb QUALITY clinical study. Further, the clinical data from the Phase IIb 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 June 2, 2026, Veru entered into a supply agreement with Novo Nordisk for this Phase IIb PLATEAU clinical trial. In this agreement, Veru is solely responsible for conducting and sponsoring the Phase IIb plateau clinical study. 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's 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 June 4, 2026. As for developments regarding enobosarm's intellectual property, the company recently announced they have received from the United States Patent and Trademark Office a notice of allowance for key methods of use U.S. patent application title, compositions comprising selective androgen receptor modulator compounds in combination with weight loss drugs and use thereof for quality of 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 said co-therapy continuing; and three, enobosarm continues to be initiated after semaglutide therapies discontinue. 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 and intramuscular fat accumulation to improve body composition and lower body fat content and lower fat mass; 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 and 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; and nine, treatment to prevent or restore lean mass loss during the rebound after discontinuing semaglutide. When issued, the U.S. 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. These allowed claims after the company's worldwide portfolio of patent applications directed to the method of use of enobosarm in combination of weight loss drugs for higher-quality weight loss and incremental weight loss including already issued in enobosarm-specific polymorph competition of matter patents as well as a number of other patent users of selective androgen receptor modulator compounds alone or in combination with weight loss drugs for quality weight loss in chronic weight management patent applications. The company continues to prosecute a number of 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 enobosarm formulation which if such a patent were to issue will provide patent protection until at least May of 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% and among the 47.4 million patients enrolled in Medicare Part D clients, which is about 20 million potential patients. Reimbursement for weight loss drugs continues to improve with patients over 65 years of age. And according to medicare.gov starting July 1, 2026, Medicare coverage of these GLP drugs, Foundayo tablet, Wegovy injection or tablet and Zepbound to QuickPen only. I will now turn the call over to Michele Greco, CFO and CAO, to discuss the financial highlights. Michele? Michele Greco: Thank you, Dr. Steiner. Let's review the results for the 3 months ended June 30, 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. We recognized a gain on the sale of ENTADFI assets of $485,000 in the prior year's quarter, which is based on nonrefundable 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. The net loss was $7 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. Now turning to the 9 months ended June 30, 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 IIb 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 and 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. 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. 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 the dispute related to a pre-closing tax receivable and liability, which resulted in income from discontinued operations. 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 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. 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. Our net working capital was $21.1 million on June 30, 2026 compared to $11.1 million on September 30, 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 stated in 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 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. We generated cash from investing activities of $5.3 million for the 9 months ended June 30, 2026 compared to $18.9 million in the prior year period. 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 for the 9 months ended June 30, 2026, was $23.3 million which was the proceeds from the underwritten public offering, net of commissions and costs. We used cash and financing activities for the 9 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. Now I'd like to turn the call back to Dr. Steiner. Dr. Steiner? Mitchell Steiner: Thank you. With that, I'll now open the call to questions. Operator? Operator: [Operator Instructions] Our first question comes from Leland Gershell with Oppenheimer. Leland Gershell: Glad to hear all the progress with the PLATEAU study and so forth. Just question from us on the IP, the new patent on the use of enobosarm -- in combination with enobosarm. I'm 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 mentioned, Foundayo 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. Mitchell Steiner: Yes. So first of all, it's a great question. So the first question is why is this patent so significant for our company, and then second, what does it mean for the other things that we're prosecuting at this point. So the first part is enobosarm in combination with semaglutide is a brand new -- the combination with a weight loss drug is a brand-new concept. The weight loss drugs took us by storm, and we immediately found out that weight loss drugs, you end up with a situation, where you lost lean and lost physical function, in comes enobosarm. 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 the enobosarm or with enobosarm being given after a patient stops a GLP-1 because they want to be [ rescued ]. And so we're 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. 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. We've 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 whatever form and whatever related to body composition and whether you give it with semaglutide or before, or somebody is 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. And it's no surprise that we have patent applications pending for the weight loss class beyond GLP-1s, and so it's not just GLP-1. So 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. And the patent office clearly sees this is as novel and not obvious. 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 were able to pick up this whole area. And from a commercial standpoint, now you have a patent in a major market just waiting for the additional patents to make their way through the system. So yes, the idea is to be broadly used. But with that said, our -- as you said, our clinical development is with semaglutide at this point, and to have that all covered initially is important for the company. And that's why I'm happy the semaglutide one came first because we're doing semaglutide in our clinical development program at this point. Does that make sense? Leland Gershell: Yes, that's great. Mitchell Steiner: In fact, and as I think about it, I think the patent is one of many things that happened this 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. And remember, we were the company with our previous experience in frailty and cancer wasting saying that the older patients will be more at risk, and that's what's happening. The field is moving in our direction where people are saying younger patients, we're not quite sure what it means, but it's non-selective weight loss, but everybody agrees that older patients is a problem. And of course, we have data that we've presented that shows that they have a 45% decline and greater than 10% stair climb power in patients on a GLP-1 alone if you're over the age of 60, so it's a real problem. And so we're seeing the fuel kind of move near 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, so you can almost see what the label will 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. The FDA wants you to pick a patient population, that's where we're spending a lot of time defining. Now with that said, not only is the indication coming our direction, but also we have a near-term milestones now by having the trial completely enrolled with 239 patients. Our first milestone coming up is Q1 2027. 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. 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. And as you know, there's two big players, it's Lilly and Novo, and everybody else is trying to get into the space and by now Novo and Lilly have staked out 15% weight loss to all way to 28% weight loss with their pills or their injectables. And anybody else coming in, the 80 companies or so that are developing have to do -- if they do less than 15% weight loss, they're dead in the water, and in between -- if they're greater than 28%, that's great, but if it's 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 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 could be interesting. Finally, as we mentioned in this call previously in the 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 enobosarm where the patent office considered it novel and non-obvious and it allows our patent portfolio to go to 2044 of just this asset with this patent. So 2044 is a long time, and again, we're very, very excited about that development. The market is still massive. People said, "Why are you slicing the market?" It's a massive market, as I said in my comments, prepared comments, 41.5% of the 47.4 million people in Part D of Medicare, part D is the oral part, and if you buy the drug in the pharmacy, and I guess injectables to fall in that same category if you buy it from the pharmacy, and that's 20 million-plus people. And Medicare is moving in a direction now that 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 enobosarm can do, we would be in the same category, and it should be something that Medicare would want to pay for, 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 to take notice, and we're ahead of the pack at this point. And we're highly focused on what is that commercial population that we need to understand the best benefit initially for enobosarm in combination with the GLP-1. 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. 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 on our next investors call. Thank you again. Operator: The digital replay of the conference call will be available beginning approximately 12 p.m. Eastern Time today, August 10, by dialing 1 (855) 669-9658 in the U.S. 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. Before you buy stock in Veru, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Veru wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. 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-- Phase 2b PLATEAU clinical trial of enobosarm and semaglutide combination for high quality weight loss is fully enrolled with 239 patients – -- Phase 2b PLATEAU clinical trial interim analysis and results on track for calendar Q1 2027-- -- In June 2026 Company announced a clinical supply agreement with Novo Nordisk for its Phase 2b PLATEAU clinical trial -- -- In August 2026 Company announced USPTO notice of allowance for key U.S. patent for enobosarm and semaglutide; when issued, U.S. patent protection until at least October 2044 -- -- Company to host conference call and webcast today at 8:00 a.m. ET – MIAMI, FL, Aug. 10, 2026 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, today announced financial results for its fiscal 2026 third quarter ended June 30, 2026, and provided an update on progress of its clinical development programs. “We are extremely pleased with the continued enobosarm progress during this past quarter,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru Inc. “We reached full enrollment of the Phase 2b PLATEAU clinical trial and entered into a clinical supply agreement with Novo Nordisk for the Phase 2b PLATEAU clinical trial.* In addition, we received from the USPTO a notice of allowance for a key U.S. patent for enobosarm with semaglutide for high quality weight loss which when issued, will provide U.S. patent protection until at least October 2044.” Dr. Steiner added: “We believe these accomplishments mark important milestones in advancing enobosarm as a potential important combination therapy with GLP-1 receptor agonists. There is a significant unmet medical need to make weight reduction more tissue selective by maximizing fat loss while preserving lean mass, physical function, and bone mineral density for the highest quality weight reduction especially in older patients who have low muscle reserves and obesity. I want to thank both the patients and the investigators for their enthusiasm to expeditiously reach full enrollment for this very important study. We remain on track to achieve the near-term milestone of reporting the interim analysis results from the Phase 2b PLATEAU clinical trial in the first quarter of calendar year 2027.” Obesity ProgramEvaluating enobosarm in combination with GLP-1 RA for higher quality weight reduction in older patients with obesity Fully Enrolled Phase 2b PLATEAU Clinical StudyThe Phase 2b PLATEAU clinical trial is a double-blind, placebo-controlled study to evaluate the effect of enobosarm 3mg on total body weight, fat mass, lean mass, physical function, bone mineral density and safety in older patients (age ≥ 65 years) who have obesity (BMI ≥ 35) and are initiating semaglutide treatment for weight reduction. During the past quarter, the Company exceeded its Phase 2b PLATEAU clinical trial targeted full enrollment of 200 patients by enrolling 239 patients. The Phase 2b PLATEAU study is designed to assess the ability of enobosarm treatment to break through the weight loss plateau observed in patients with obesity receiving GLP-1 RA treatment by preserving muscle mass and physical function to achieve clinically meaningful incremental weight reduction by 68 weeks. The primary efficacy endpoint of the study is the percent change from baseline in total body weight at 68 weeks. The key secondary endpoints are total fat mass, total lean mass, physical function (stair climb test), mobility disability assessment, bone mineral density, and patient reported outcome questionnaires for physical function, HbA1c, and insulin resistance. Results of an interim analysis assessing lean body mass and fat mass as measured by DXA after patients have completed 32 weeks is expected in the first quarter of calendar year 2027. Final topline clinical data is expected in the fourth quarter of calendar year 2027. The Principal Investigator for the Phase 2b PLATEAU clinical trial is Steven Heymsfield, MD, a Professor and the Director of the Body Composition-Metabolism Laboratory at the Pennington Biomedical Research Center in Baton Rouge, Louisiana. Dr. Heymsfield was also the Principal Investigator of Veru’s Phase 2 QUALITY clinical study. Completed Positive Phase 2b QUALITY Clinical StudyThe Phase 2b QUALITY clinical study was a positive multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial that evaluated the safety and efficacy of enobosarm 3 mg, enobosarm 6 mg, or placebo as a treatment to augment fat loss and to prevent muscle loss in 168 older patients (≥60 years of age) receiving semaglutide (Wegovy®**) for weight reduction. After the efficacy dose-finding portion of the Phase 2b QUALITY clinical trial was completed at 16 weeks, participants continued into a Phase 2b maintenance extension study where all patients discontinued semaglutide treatment, but continued receiving placebo, enobosarm 3 mg, or enobosarm 6 mg as monotherapy in a double-blind fashion for 12 weeks. The Phase 2b QUALITY and Maintenance Extension clinical trial was a positive study that demonstrated that enobosarm plus semaglutide preserved lean mass and physical function and led to greater fat loss during the 16 week active weight loss period and enobosarm monotherapy prevented the regain of weight lost when the GLP-1 RA was discontinued. Recent Developments Regarding Enobosarm Intellectual PropertyRecently the Company received from the United States Patent and Trademark Office (USPTO) a Notice of Allowance for U.S. Patent Application titled “Compositions Comprising Selective Androgen Receptor Modulator Compounds in Combination with Weight Loss Drugs and Uses Thereof for Quality Weight Loss.” The Notice of Allowance indicates that the USPTO has determined that the patent application meets the requirements for patentability and is expected to issue as a U.S. patent. The Notice of Allowance encompasses treatment regimens where: (i) enobosarm is concurrently given with semaglutide; (ii) enobosarm is added to initial semaglutide monotherapy with said co-therapy continuing; and (iii) enobosarm continues or is initiated as monotherapy after semaglutide therapy is discontinued. The allowed claims are directed to the: (i) preservation, restoration, or gaining of lean body mass; (ii) preservation, restoration, or gaining of muscle mass; (iii) enhancement of fat mass loss, including reducing abdominal, subcutaneous, or intramuscular fat accumulation, improving body composition, lowering body fat content, and lowering fat mass; (iv) preservation, restoration, or improvement of physical function and the corresponding prevention or treatment of a number of conditions that can result from decreased physical function such as reducing or treating muscle weakness, 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; (v) preservation, restoration, or gaining of bone, and the corresponding prevention or treatment of bone fractures; (vi) overcoming or improving of insulin resistance; (vii) improving of HbA1c; (viii) reduction of or treatment to prevent total body weight gain rebound after discontinuing semaglutide; (ix) reduction of or treatment to prevent fat mass gain rebound after discontinuing semaglutide; and (x) treatment to prevent or restore lean mass loss during rebound after discontinuing semaglutide. When issued, this U.S. 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. These allowed claims add to the Company’s growing intellectual property portfolio for enobosarm for quality weight loss, including already issued enobosarm specific polymorph composition of matter patents, as well as a number of other pending uses of selective androgen receptor modulator compounds alone or in combination with weight loss drugs for quality weight loss and chronic weight management patent applications.  In addition, 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. The Company owns a worldwide portfolio of patent applications directed to the methods of use of enobosarm in combination with weight loss drugs for higher quality weight loss and incremental weight loss. These claims encompass weight loss drugs including incretin containing drugs such as GLP-1 RA drugs. The Company continues to prosecute a number of pending patent applications worldwide covering a number of different weight loss drugs beyond semaglutide. Third Quarter Financial Summary: Fiscal 2026 vs Fiscal 2025 Research and development expenses increased to $4.4 million from $3.0 million General and administrative expenses decreased to $3.4 million from $5.0 million Operating loss from continuing operations increased to $7.7 million from $7.5 million Net loss decreased to $7.0 million, or $0.30 per share, compared to $7.3 million, or $0.50 per share Year-to-Date Financial Summary: Fiscal 2026 vs Fiscal 2025 Research and development expenses decreased to $8.8 million from $12.7 million General and administrative expenses decreased to $11.5 million from $15.4 million Operating loss from continuing operations decreased to $20.4 million from $25.9 million Net loss decreased to $15.1 million, or $0.68 per share, compared to $24.2 million, or $1.65 per share Balance Sheet Information ​​​​​Cash, cash equivalents and restricted cash were $23.9 million as of June 30, 2026 versus $15.8 million as of September 30, 2025 Event DetailsThe audio webcast will be accessible under the Home page and Investors page of the Company’s website at www.verupharma.com. To join the conference call via telephone, please dial 1-800-341-1602 (domestic) or 1-412-902-6706 (international) and ask to join the Veru Inc. call. An archived version of the audio webcast will be available for replay on the Company’s website for approximately three months. A telephonic replay will be available at approximately 12:00 p.m. ET by dialing 1-855-669-9658 (domestic) or 1-412-317-0088 (international), passcode 2565519, for one week. About Veru Inc.Veru is a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases. The Company’s drug development program includes two late-stage novel small molecules, enobosarm and sabizabulin. Enobosarm, an oral selective androgen receptor modulator (SARM), is being developed as a next generation drug that makes weight reduction by GLP-1 RA drugs more tissue selective for loss of fat and preservation of lean mass to improve body composition and physical function which is expected to result in clinically meaningful incremental weight reduction versus GLP-1 RA therapy alone. Sabizabulin, a microtubule disruptor, is being developed for the treatment of chronic inflammation related to atherosclerotic cardiovascular disease. Forward-Looking StatementsThis press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, express or implied statements related to the planned design, enrollment, timing, commencement, interim, topline and full data readout timing, scope and regulatory pathways for the continued development of enobosarm in patients with obesity, including the PLATEAU Phase 2b study; express or implied statements related to the issuance and scope of coverage, including allowed claims and treatment regimens, of a method of use patent from the Notice of Allowance for US Patent Application titled “Compositions Comprising Selective Androgen Receptor Modulator Compounds in Combination with Weight Loss Drugs and Uses Thereof for Quality Weight Loss”, as well as other pending methods of use and formulation patents; whether the patent application meets requirements of patentability and, if and when the patent is issued, will provide patent protection until at least October 2044; whether new indications will be discovered or granted and whether the allowed claims under said Notice of Allowance, if and when issued, will add additional coverage and protection to new indications and the Company’s growing intellectual property portfolio for enobosarm for quality weight loss, and other pending uses of selective androgen receptor modulator compounds alone or in combination with weight loss drugs; whether the pending patent applications will be approved for claims that encompass a novel, oral, modified-release enobosarm formulation and if issued, will provide patent protection until at least May 2046; the planned design, number of sites, timing, endpoints, patient population and patient size of such trial and whether the PLATEAU trial will successfully meet any of its primary or secondary endpoints; whether the results of the Phase 2b QUALITY study and the extension maintenance study of enobosarm, including weight loss, preservation of lean mass and physical function and loss of fat mass and the prevention of the regain of fat mass and total body weight loss, will be replicated to the same or any degree in the PLATEAU Phase 2b study or in any future Phase 3 studies; whether and when the PLATEAU Phase 2b study of enobosarm will produce an interim analysis and/or topline data; whether enobosarm in combination with a GLP-1 RA drug will provide a higher quality and/or greater quantity weight loss in patients and whether enobosarm will be the next generation combination therapy with GLP-1 receptor agonists for older patients with obesity that makes weight reduction more tissue selective for loss of fat, preservation of lean mass, physical function, improved body composition and maintaining or increasing bone mineral density, and demonstrating favorable HbA1c and insulin resistance results, all while maintaining a favorable safety profile; whether patients treated with enobosarm in the PLATEAU Phase 2B study will break through the weight loss plateau and achieve clinically meaningful incremental weight reduction by preserving muscle mass and physical function whether enobosarm will enhance or achieve a higher quality weight loss or the preservation of muscle in, or meet any unmet need for, obesity patients, including whether it will provide important insights into quality weight loss therapy and the design of a Phase 3 clinical development program; and whether the Company will be successful in its transformation into a late stage biopharmaceutical company focused on obesity and inflammatory disease. The words "anticipate," "believe," "could," "expect," "intend," "may," "opportunity," "plan," "predict," "potential," "estimate," "should," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based upon current plans and strategies of the Company and reflect the Company's current assessment of the risks and uncertainties related to its business and are made as of the date of this press release. The Company assumes no obligation to update any forward-looking statements contained in this press release because of new information or future events, developments, or circumstances. Such forward-looking statements are subject to known and unknown risks, uncertainties and assumptions, and if any such risks or uncertainties materialize or if any of the assumptions prove incorrect, our actual results could differ materially from those expressed or implied by such statements. Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to: the development of the Company’s product portfolio and the results of clinical studies, including any interim or topline analysis, possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; although the Company has sought and received feedback from the FDA on the designs of its clinical trials and intends to continue to do so, the FDA may ultimately disagree that the Company’s clinical trials support approval; the Company’s ability to reach agreement with FDA on study design requirements for the Company’s planned clinical studies, including for the Phase 2b program for enobosarm as a weight loss or body composition drug and the number of future Phase 3 studies to be required and the cost thereof; potential delays in the timing of and results from clinical trials and studies, including as a result of an inability to enroll sufficient numbers of patients in clinical studies or an inability to enroll patients in accordance with planned schedules; the ability to fund planned clinical development as well as other operations of the Company; the Company plans to prioritize the use of its current internal cash to the development of enobosarm, with a primary near-term focus on funding its PLATEAU Phase 2b clinical trial, and as a result advancement of sabizabulin as a treatment for slowing progression of or promoting regression of atherosclerosis disease will depend upon the Company securing additional funding; whether the Company will be able to partner with another company in the development of enobosarm or sabizabulin; the timing of any submission to the FDA or any other regulatory authority and any determinations made by the FDA or any other regulatory authority; the potential for disruptions at the FDA or other government agencies to negatively affect our business, including as a result of a future shutdown of the U.S. government; any products of the Company, if approved, possibly not being commercially successful; the risk that the Supply Agreement with Novo Nordisk could be terminated prior to the completion of the Company’s PLATEAU Phase 2b clinical trial, including pursuant to a provision that permits Novo Nordisk to terminate for convenience upon 60 days’ prior notice; the ability of the Company to obtain sufficient financing, including any partnership or collaboration agreements, on acceptable terms when needed to fund development and operations and to enable us to continue as a going concern; the effect of the SEC’s “baby shelf” rules on the Company’s ability to raise sufficient capital when needed; demand for, market acceptance of, and competition against any of the Company’s products or product candidates; new or existing competitors with greater resources and capabilities and new competitive product approvals and/or introductions; changes in regulatory practices or policies or government-driven healthcare reform efforts, including pricing pressures and insurance coverage and reimbursement changes; the Company’s ability to obtain, protect and enforce its data, intellectual property and other proprietary rights; costs and other effects of litigation, including regulatory challenges, product liability claims, intellectual property claims and challenges, securities litigation and litigation with the purchaser of the Company’s FC2 business; the Company’s ability to identify, successfully negotiate and complete suitable acquisitions or other strategic initiatives; the Company’s ability to successfully integrate acquired businesses, technologies or products; and other risks detailed from time to time in the Company’s press releases, shareholder communications and Securities and Exchange Commission filings, including the Company's Form 10-K for the year ended September 30, 2025, and subsequent quarterly reports on Form 10-Q. These documents are available on the “SEC Filings” section of our website at www.verupharma.com/investors. *During the past quarter the Company announced a clinical supply agreement with Novo Nordisk for its Phase 2b PLATEAU clinical study. Please see the Company’s SEC Form 8-K dated June 2, 2026 for further details. **Wegovy® is a registered trademark of Novo Nordisk A/S. FINANCIAL SCHEDULES FOLLOW Investor and Media Contact: Samuel FischExecutive Director, Investor Relations and Corporate CommunicationsEmail: [email protected]

MIAMI, FL, Aug. 03, 2026 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, today announced it will host a conference call and audio webcast on Monday, August 10, 2026, at 8:00 a.m. ET to discuss its fiscal 2026 third quarter financial results and to provide a business update. The audio webcast will be accessible under the Home page and Investors page of the Company’s website at www.verupharma.com. To join the conference call via telephone, please dial 1-800-341-1602 (domestic) or 1-412-902-6706 (international) and ask to join the Veru Inc. call. An archived version of the audio webcast will be available for replay on the Company’s website for approximately three months. A telephonic replay will be available at approximately 12:00 p.m. ET by dialing 1-855-669-9658 (domestic) or 1-412-317-0088 (international), passcode 2565519, for one week. Veru Obesity Program: Evaluating enobosarm in combination with GLP-1 RA for higher quality weight reduction in older patients with obesity Fully Enrolled Phase 2b PLATEAU Clinical StudyPhase 2b PLATEAU clinical trial is a double-blind, placebo-controlled study to evaluate the effect of enobosarm 3mg on total body weight, fat mass, lean mass, physical function, bone mineral density and safety in approximately 200 older patients (age ≥ 65 years) who have obesity (BMI ≥ 35) and are initiating semaglutide treatment for weight reduction. The Phase 2b PLATEAU study is designed to assess the ability of enobosarm treatment to break through the weight loss plateau observed in patients with obesity receiving GLP-1 RA treatment by preserving muscle mass and physical function to achieve clinically meaningful incremental weight reduction by 68 weeks. The primary efficacy endpoint of the study is the percent change from baseline in total body weight at 68 weeks. The key secondary endpoints are total fat mass, total lean mass, physical function (stair climb test), mobility disability assessment, bone mineral density, and patient reported outcome questionnaires for physical function, HbA1c, and insulin resistance. Results of an interim analysis assessing lean body mass and fat mass as measured by DXA after subjects have completed 32 weeks is expected in the first quarter of calendar year 2027. Final topline clinical data is expected in the fourth quarter of calendar year 2027. In June 2026 Veru announced a clinical supply agreement with Novo Nordisk for its Phase 2b PLATEAU clinical study*. Please see the Company’s SEC Form 8-K dated June 2, 2026 for further details. Completed Phase 2b QUALITY Clinical StudyThe Phase 2b QUALITY clinical study is a positive multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial that evaluated the safety and efficacy of enobosarm 3 mg, enobosarm 6 mg, or placebo as a treatment to augment fat loss and to prevent muscle loss in 168 older patients (≥60 years of age) receiving semaglutide (Wegovy®**) for weight reduction. After the efficacy dose-finding portion of the Phase 2b QUALITY clinical trial was completed at 16 weeks, participants continued into a Phase 2b maintenance extension study where all patients discontinued semaglutide treatment, but continued receiving placebo, enobosarm 3 mg, or enobosarm 6 mg as monotherapy in a double-blind fashion for 12 weeks. The Phase 2b QUALITY and Maintenance Extension clinical trial was a positive study that demonstrated that enobosarm plus semaglutide preserved lean mass and physical function, and led to greater fat loss during the 16 week active weight loss period and enobosarm monotherapy prevented the regain of weight lost when the GLP-1 RA was discontinued. About Veru Inc.Veru is a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases. The Company’s drug development program includes two late-stage novel small molecules, enobosarm and sabizabulin. Enobosarm, an oral selective androgen receptor modulator (SARM), is being developed as a next generation drug that makes weight reduction by GLP-1 RA drugs more tissue selective for loss of fat and preservation of lean mass to improve body composition and physical function which is expected to result in clinically meaningful incremental weight reduction versus GLP-1 RA therapy alone. Sabizabulin, a microtubule disruptor, is being developed for the treatment of chronic inflammation related to atherosclerotic cardiovascular disease. Forward-Looking StatementsThis press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, express or implied statements related to the planned design, enrollment, timing, commencement, interim, topline and full data readout timing, scope and regulatory pathways for the continued development of enobosarm in patients with obesity, including the PLATEAU Phase 2b study; the planned design, number of sites, timing, endpoints, patient population and patient size of such trial and whether the PLATEAU trial will successfully meet any of its primary or secondary endpoints; whether the results of the Phase 2b QUALITY study and the extension maintenance study of enobosarm, including weight loss, preservation of lean mass and physical function and loss of fat mass, will be replicated to the same or any degree in the PLATEAU Phase 2b study or in any future Phase 3 studies; whether and when the PLATEAU Phase 2b study of enobosarm will produce an interim analysis and/or topline data; whether enobosarm in combination with a GLP-1 RA drug will provide a higher quality and/or greater quantity weight loss in patients and whether enobosarm will be the next generation combination therapy with GLP-1 receptor agonists for older patients with obesity drug that makes weight reduction more tissue selective for loss of fat, preservation of lean mass, physical function, improved body composition and maintaining or increasing bone mineral density, and demonstrating favorable HbA1c and insulin resistance results, all while maintaining a favorable safety profile; whether patients treated with enobosarm in the PLATEAU Phase 2B study will break through the weight loss plateau and achieve clinically meaningful incremental weight reduction by preserving muscle mass and physical function; whether enobosarm will enhance or achieve a higher quality weight loss or the preservation of muscle in, or meet any unmet need for, obesity patients, including whether it will enable patients to break through the weight loss plateau or provide important insights into quality weight loss therapy and the design of a Phase 3 clinical development program; and whether the Company will be successful in its transformation into a late stage biopharmaceutical company focused on obesity and inflammatory disease. The words "anticipate," "believe," "could," "expect," "intend," "may," "opportunity," "plan," "predict," "potential," "estimate," "should," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based upon current plans and strategies of the Company and reflect the Company's current assessment of the risks and uncertainties related to its business and are made as of the date of this press release. The Company assumes no obligation to update any forward-looking statements contained in this press release because of new information or future events, developments, or circumstances. Such forward-looking statements are subject to known and unknown risks, uncertainties and assumptions, and if any such risks or uncertainties materialize or if any of the assumptions prove incorrect, our actual results could differ materially from those expressed or implied by such statements. Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to: the development of the Company’s product portfolio and the results of clinical studies, including any interim or topline analysis, possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; although the Company has sought and received feedback from the FDA on the designs of its clinical trials and intends to continue to do so, the FDA may ultimately disagree that the Company’s clinical trials support approval; the Company’s ability to reach agreement with FDA on study design requirements for the Company’s planned clinical studies, including for the Phase 2b program for enobosarm as a weight loss or body composition drug and the number of future Phase 3 studies to be required and the cost thereof; potential delays in the timing of and results from clinical trials and studies, including as a result of an inability to enroll sufficient numbers of subjects in clinical studies or an inability to enroll subjects in accordance with planned schedules; the ability to fund planned clinical development as well as other operations of the Company; the Company plans to prioritize the use of its current internal cash to the development of enobosarm, with a primary near-term focus on funding its PLATEAU Phase 2b clinical trial, and as a result advancement of sabizabulin as a treatment for slowing progression of or promoting regression of atherosclerosis disease will depend upon the Company securing additional funding; whether the Company will be able to partner with another company in the development of enobosarm or sabizabulin; the timing of any submission to the FDA or any other regulatory authority and any determinations made by the FDA or any other regulatory authority; the potential for disruptions at the FDA or other government agencies to negatively affect our business, including as a result of a future shutdown of the U.S. government; any products of the Company, if approved, possibly not being commercially successful; the risk that the Supply Agreement with Novo Nordisk could be terminated prior to the completion of the Company’s PLATEAU Phase 2b clinical trial, including pursuant to a provision that permits Novo Nordisk to terminate for convenience upon 60 days’ prior notice; the ability of the Company to obtain sufficient financing, including any partnership or collaboration agreements, on acceptable terms when needed to fund development and operations and to enable us to continue as a going concern; the effect of the SEC’s “baby shelf” rules on the Company’s ability to raise sufficient capital when needed; demand for, market acceptance of, and competition against any of the Company’s products or product candidates; new or existing competitors with greater resources and capabilities and new competitive product approvals and/or introductions; changes in regulatory practices or policies or government-driven healthcare reform efforts, including pricing pressures and insurance coverage and reimbursement changes; the Company’s ability to obtain, protect and enforce its data, intellectual property and other proprietary rights; costs and other effects of litigation, including regulatory challenges, product liability claims, intellectual property claims and challenges, securities litigation and litigation with the purchaser of the Company’s FC2 business; the Company’s ability to identify, successfully negotiate and complete suitable acquisitions or other strategic initiatives; the Company’s ability to successfully integrate acquired businesses, technologies or products; and other risks detailed from time to time in the Company’s press releases, shareholder communications and Securities and Exchange Commission filings, including the Company's Form 10-K for the year ended September 30, 2025, and subsequent quarterly reports on Form 10-Q. These documents are available on the “SEC Filings” section of our website at www.verupharma.com/investors.*Novo Nordisk’s participation in the PLATEAU study does not constitute endorsement of enobosarm or the combination approach tested in the study and Novo Nordisk’s supply of Wegovy® for the study does not constitute any representation regarding Wegovy’s requirement for adjunctive therapy. **Wegovy® is a registered trademark of Novo Nordisk A/S. Investor and Media Contact: Samuel FischExecutive Director, Investor Relations and Corporate CommunicationsEmail: [email protected]

Veru Inc. reported a substantial improvement in its Q2 fiscal year 2026 financial performance, marked by a significant reduction in net loss and operating expenses. The company’s stock saw a premarket rise of 3.52%, reflecting investor optimism. With a focus on its lead asset, enobosarm, Veru continues to drive innovation in obesity treatment. Key Takeaways See what 10M+ investors are talking about. Get the Stocktwits Daily Rip for what retail is watching right now, free to your inbox Veru’s net loss improved by 75.9% from the previous year’s quarter. R&D and SG&A expenses were significantly reduced, contributing to improved financial metrics. The company’s cash position increased by 74.7% to $27.6 million. Enobosarm shows promise in addressing weight loss plateaus in obesity treatment. Veru Inc. demonstrated a marked improvement in its financial health during Q2 FY2026. The company reduced its net loss from continuing operations to $3.1 million, a significant improvement from the $7.9 million loss reported in the same quarter the previous year. This performance reflects the company’s effective cost management and strategic focus on its core assets. With a market capitalization of $36.43 million, the biotech firm continues navigating its development phase. Net Loss from Continuing Operations: $3.1 million, a 75.9% improvement year-over-year. Total Net Loss: $2.7 million, compared to $7.9 million in the prior year quarter. R&D Costs: Decreased by 20.5% to $3.1 million. SG&A Expenses: Reduced by 21.2% to $4.1 million. Cash Position: Increased to $27.6 million from $15.8 million as of September 2025. Net Working Capital: Increased by 152.3% to $28.0 million. Veru’s stock price rose by 3.52% in premarket trading, reaching $2.35. This positive movement reflects investor confidence in the company’s strategic direction and financial improvements. The stock’s rise comes in the context of a challenging market environment, highlighting Veru’s resilience and potential growth prospects. Veru’s future guidance includes projected EPS losses for the upcoming quarters and fiscal years, with expectations of a -$0.44 EPS for Q3 FY2026 and a -$0.49 EPS for Q4 FY2026. Despite these projections, the company is optimistic about its ongoing clinical trials and product development initiatives, particularly with enobosarm.For investors seeking comprehensive analysis, Veru is one of 1,400+ US equities covered by InvestingPro’s detailed Pro Research Reports, which transform complex Wall Street data into clear, actionable intelligence through intuitive visuals and expert analysis. Dr. Mitchell Steiner, Chairman, CEO, and President, emphasized, "Our strategic focus on enobosarm positions us uniquely in the obesity treatment market, addressing critical challenges faced by current therapies." This statement underscores the company’s commitment to innovation and its potential impact on market dynamics. Regulatory Approvals: The success of enobosarm depends on favorable regulatory outcomes. Market Competition: Intense competition in the obesity treatment market could impact market share. Clinical Trial Outcomes: The ongoing Phase IIb PLATEAU trial’s results are crucial for future product development. Economic Conditions: Broader economic pressures could affect consumer spending and healthcare funding. This comprehensive analysis of Veru Inc.’s Q2 FY2026 performance highlights the company’s financial improvements and strategic focus on innovative treatments, positioning it for potential future growth in the competitive healthcare sector. Full transcript - Veru Inc (VERU) Q2 2026: Operator: Good morning, ladies and gentlemen, and welcome to Veru Inc.’s Investors Conference Call. I would now like to turn the conference over to Mr. Samuel Fisch, Veru Inc.’s Executive Director, Investor Relations and Corporate Communications. Please go ahead. Samuel Fisch, Executive Director of Investor Relations and Corporate Communications, Veru Inc.: Good morning. 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 Form 10-Q and Form 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. Dr. Mitchell Steiner, Chairman, Chief Executive Officer, and President, Veru Inc.: Good morning. With me on this morning’s call are Dr. K. Gary Barnette, the Chief Scientific Officer; Michele Greco, the Chief Financial Officer and Chief Administrative Officer; Philip Greenberg, General Counsel; and Samuel Fisch, the Executive Director of Investor Relations and Corporate Communications. Thank you for joining our second 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 disease. Our drug development program consists of two novel small molecules, enobosarm and sabizabulin. The first one, enobosarm, is an oral selective androgen receptor modulator, SARM, and it’s 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 it’s 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’ll focus on an update of the clinical development progress of enobosarm in our obesity program. We’ll also provide financial highlights for fiscal 2026 second quarter ended March 31st, 2026. GLP-1 receptor agonists 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 the significant indiscriminate loss of both lean mass and fat mass. Of the total weight loss, up to 50% is attributable to lean mass. Although GLP-1 receptor agonist treatments have resulted in substantial weight loss for many patients, the strategy for the next generation of obesity drugs should be a combination therapy with a GLP-1 receptor agonist to cause patients to only lose fat while preserving lean mass and physical function and bone mineral density for the highest quality weight reduction. Now, Veru has focused the clinical development of enobosarm for weight loss on older patients who have obesity. More specifically, the focus has been on older patients who have sarcopenic obesity, which means they have both obesity and low muscle mass and are potentially at the greatest risk for reaching a critically low muscle mass, which may lead to physical function decline when taking the currently approved GLP-1 receptor agonist. According to the European Working Group on Sarcopenia in Older People 2, sarcopenia is defined by reduced muscle strength and function as the primary diagnostic criterion, confirmed by low muscle quantity and quality, while the impaired physical performance reflects disease severity. As you can see, the working group emphasis is on physical strength and function, thus muscle loss alone does not define sarcopenia. As a consequence, we have chosen to also objectively evaluate and measure physical function by a stair climb test in the Phase II QUALITY clinical study. Now, Veru has completed the Phase 2b QUALITY clinical trial with a multicenter, double-blind, placebo-controlled, randomized dose finding clinical trial designed to evaluate safety and efficacy of enobosarm 3 milligrams, enobosarm 6 milligrams or placebo as a treatment to augment fat loss and prevent muscle loss. The efficacy dose finding active weight loss portion of the phase IIb clinical trial was completed at 16 weeks. Participants continued into a phase IIb maintenance extension study where all patients discontinued semaglutide treatment but continued receiving either placebo. As I mentioned, Veru focused on the impact of weight loss on physical function, not just lean mass in older patients with obesity in the Phase 2b QUALITY clinical study. Physical function was measured by the stair climb test, which is a common activity of daily living. Decline to physical function as measured by the stair climb test may predict in older patients a higher risk for mobility disabilities, gait difficulties, falls and bone fractures, hospitalizations, and mortality. It has been reported that stair climb power declines by 1.38% annually with aging. Now, it should be noted that the Phase IIb QUALITY clinical study is the first human study to demonstrate that the weight reduction in older patients who have obesity receiving a GLP-1 receptor agonist puts them at a higher risk for accelerated loss of lean mass with physical function decline. A pre loss as it represents loss of stair climb power that would naturally occur with aging over a 7-8-year period in older patients. In a phase IIb QUALITY study, the loss of lean mass mattered as 44.3% of patients on placebo plus semaglutide group had at least a 10% decline in stair climb power physical function at 16 weeks. What happened to the study group that received enobosarm in combination with a GLP-1 receptor agonist? In the phase IIb QUALITY clinical study, enobosarm treatment preserved lean mass, 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 alone. More specifically, the enobosarm 3 mg plus semaglutide group had a statistically significant and clinically meaningful 59.8% relative reduction in proportion of patients that lost at least 10% stair climb power compared to the placebo plus semaglutide group, and that P value is 0.0006. In the enobosarm 6 mg group, plus semaglutide, there was a 44.1% relative reduction in the proportion of patients with at least a 10% decline in stair climb 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. The next important question is can you potentially have greater weight loss by adding enobosarm to a GLP-1 receptor agonist treatment? First of all, as the Phase IIb QUALITY clinical studies demonstrated, patients receiving enobosarm had greater fat loss. Plus, if you’re able to preserve muscle and physical function with enobosarm while taking a GLP-1 receptor agonist, we would expect that more calories will be burned, which is expected to result in greater weight loss compared to a GLP-1 receptor agonist alone, especially in a longer study. Let’s turn to the current progress of our Phase IIb plateau clinical study. A common clinical and therapeutic challenge with GLP-1 receptor agonist treatments is that 88% of patients after 1 year on a GLP-1 receptor agonist hit 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 1 year. One explanation might be that the loss of muscle caused by non-selective tissue 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 that weight loss plateau. enobosarm has been shown in clinical studies to directly burn fat and to preserve muscle to increase physical function and burn more calories. By preserving muscle, appetite stays suppressed while more calories are burned, which can help to break through the weight loss plateau, leading to incremental weight reduction. Now let’s turn to the design of the Phase IIb QUALITY clinical study, which is a double-blind, placebo-controlled study to evaluate the effect of enobosarm 3 milligrams on total body weight, fat mass, lean mass, and physical function, bone mineral density, and safety in approximately 200 older patients aged greater than or equal to 65 who have obesity, BMI greater than or equal to 35, and are initiating semaglutide Wegovy GLP-1 receptor agonist treatment for weight reduction. The primary efficacy endpoint of the study is percent change from baseline in total body weight at 68 weeks. An interim analysis will be conducted at 36 weeks to assess the percent change from baseline in lean body mass and total fat mass as measured by DEXA scan. The key secondary endpoints for the overall study are total fat, total lean mass, physical function, again measured by stair climb test, mobility disability assessment, bone mineral density, and 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 to break through the weight loss plateau observed in patients receiving a GLP-1 receptor agonist treatment. To achieve clinically meaningful incremental weight reduction, as well as to preserve muscle mass and physical function by 68 weeks. The interim analysis of the clinical study will occur when all patients have been treated for 36 weeks. Now, semaglutide was selected as a GLP-1 receptor agonist for the phase IIb plateau study to build on Veru’s previous clinical experience using enobosarm in combination with semaglutide in the positive phase II QUALITY clinical study. Further, the clinical data from the phase IIb plateau clinical study using injectable semaglutide may support the use of oral semaglutide and oral enobosarm fixed dose combination in future phase III clinical studies. Contrast, there are no approved oral formulations for tirzepatide. On the March 9, 2026, we announced the enrollment of the first patients in the phase IIb plateau clinical study. I’m very pleased with the current enrollment rate, and we’re on track for results of the 36 interim analysis, which is expected in Q1 calendar year 2027. Now Veru is targeting the at-risk older patients with sarcopenic obesity. How large is that market? How about the total market for obesity? The Wall Street Journal reported last week that there are more than 1 billion people in the world with obesity. The World Health Organization estimates that there are 2.5 billion adults globally who are either overweight or obese, with the rate of adult obesity more than doubling since 1990. Right now, there are only two companies, Lilly and Novo Nordisk, that together are treating less than 2% of them. How about the total market for sarcopenic obesity? The overall prevalence of obesity and low muscle mass is almost 30 million adults in the U.S. How about the total market of patients who are 65 years and older with obesity? The prevalence of obesity in patients who are 65 years and older is 41.5% among the 47.4 million patients enrolled in Medicare Part D plans. That’s about 20 million potential patients. As you can see, taken together, the market opportunity for enobosarm in combination with GLP-1 receptor agonist in older patients with sarcopenic obesity is very large. I will now turn the call over to Michele Greco, CFO, CAO, to discuss the financial highlights. Michele. Michele Greco, Chief Financial Officer and Chief Administrative Officer, Veru Inc.: Thank you, Dr. Steiner. Let’s review the results for the 3 months ended March 31st, 2026. Research and development costs decreased to $3.1 million from $3.9 million in the prior quarter. The decrease is primarily due to wind down of the Phase IIb QUALITY clinical study for enobosarm as a treatment to augment fat loss and prevent muscle loss, which was completed during fiscal 2025. Personnel costs also decreased primarily due to the reduced share-based compensation expense. Selling, general, and administrative expenses were $4.1 million compared to $5.2 million in the prior quarter. The decrease is primarily due to a decrease in the share-based compensation expense. We recognized a gain on the sale of Antahi assets of $974,000 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 OnKinetics, which included payment of Series D preferred stock and warrants. During the current period, the increase in fair value of the equity securities received was $3.9 million as a result of the realized gain from the conversion of the preferred stock and then sale of the underlying common stock and change in the fair value of the remaining preferred stock and warrants. Favorable anti-dilution provisions triggered by the OnKinetics reverse stock split during the period contributed to the increase in the fair value. The bottom line result for continuing operations was a net loss of $3.1 million, or $0.13 per diluted common share, compared to a net loss of $7.9 million, or $0.54 per diluted common share in the prior year’s quarter. During the quarter, 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. 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. Net loss was $2.7 million or $0.12 per diluted common share, compared to a net loss of $7.9 million or $0.54 per diluted common share in the prior quarter. Turning to the results for the 6 months ended March 31st, 2026. Research and development costs decreased to $4.5 million from $9.6 million in the prior period. The decrease is primarily due to a wind down of the Phase IIb QUALITY clinical study for enobosarm as a treatment to augment fat loss and prevent muscle loss, which was completed during fiscal 2025. Personnel costs also decreased primarily due to the reduced share-based compensation expense. Selling general administrative expenses were $8.2 million compared to $10.4 million in the prior period. The decrease is primarily due to a decrease in the share-based compensation expense. We recognized a gain on the sale of the ENTADFI assets of $1.7 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 current period, the company recorded a gain of $3.8 million from the increase in the fair value of equity securities compared to a loss from the decrease in fair value of equity securities of $0.3 million in the prior period. The increase in fair value of the equity securities during the current year period is the result of a realized gain from the conversion of the OnKinetics preferred stock and sale of the underlying common stock and change in fair value of the remaining preferred stock and warrants. Favorable anti-dilution provisions triggered by the OnKinetics reverse stock split during the period contributed to the increase in fair value. The bottom line results for continuing operations was a net loss of $8.4 million or $0.39 per diluted common share, compared to a net loss of $9.6 million or $0.66 per diluted common share in the prior period. The net loss was $8.1 million or $0.38 per diluted common share, compared to a net loss of $16.8 million or $1.15 per diluted common share in the prior period. Looking at the balance sheet. As of March 31, 2026, our cash equivalents, and restricted cash balance was $27.6 million compared to $15.8 million as of September 30, 2025. On both March 31, 2026 and September 30, 2025, there was $0.1 million of restricted cash related to the sale of the FC2 Female Condom business. Our net working capital was $28 million on March 31, 2026, compared to $11.1 million on September 30, 2025. On October 31, 2025, Veru 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 share of common stock and the accompanying Series A and Series 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. The company is not profitable and has had negative cash flows from operations. Based on 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 clinical study that would be performed to assess percent change from baseline in lean body mass and fat mass as measured by DEXA scans. During the 6 months ended March 31st, 2026, we used cash of $15.1 million for operating activities, compared with $19.1 million used for operating activities in the prior period. We generated cash from investing activities of $3.5 million for the 6 months ended March 31st, 2026, compared to $18.4 million in the prior period. The cash generated during the current period represents proceeds from the sale of the OnKinetics equity securities of $3.2 million and $0.3 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 $1.7 million from the sale of Antahi assets, and proceeds of $393,000 from the sale of equity securities. Net proceeds provided by financing activities for the six months ended March 31, 2026 was $23.4 million, which were the proceeds from the sale of common stock and warrants in an underwritten public offering, net of commissions and costs. We used cash and financing activities for the 6 months ended March 31st, 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 now like to turn the call back to Dr. Steiner. Dr. Steiner? Dr. Mitchell Steiner, Chairman, Chief Executive Officer, and President, Veru Inc.: Thank you, Michele. 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’s star then one to rejoin the question queue. We will pause momentarily to assemble our roster. The first question today comes from Leland Gershell with Oppenheimer. Please go ahead. Leland Gershell, Analyst, Oppenheimer: Hey, good morning. A couple of questions from us. Assuming success in the Plateau study, would you expect to need two phase IIIs, or could you perhaps get by with one pivotal and perhaps use Plateau as supportive? Also wanted to ask in further studies with enobosarm Given the development of evolving agents for obesity, you know, some orals are coming through. Others want to know if the design would capture those agents as well. Would the ultimate label be agnostic to the primary weight loss agent? Would you need to study the specific weight loss agents to have those reflected in the indication label for an enobosarm? Thank you. Dr. Mitchell Steiner, Chairman, Chief Executive Officer, and President, Veru Inc.: Thank you, Leland Gershell. The first question is basically, if we’re successful, you know, what is the next step? Do you go to a phase III? Let’s be very clear what that means. As you know, the FDA has come back and told us that incremental weight loss of greater than 5% for the efficacy portion of the study is sort of the anchor. Okay. If you have greater than 5%, that stands on its own. If you wanna add the function benefits and the bone benefits, then you have to show those separately. You at least you’re moving forward with incremental weight loss. If your incremental weight loss is less than 5%, then you have two ways to move forward. One is physical function as a primary endpoint. The reason the phase IIb is so important is because we’re doing a lot of work on physical function to make sure that we have a very clear understanding of the phase III endpoint for physical function as a claim. Furthermore, if we’re collecting bone mineral density information, as you know, the FDA has recently reported back in December of 2025 that BMD alone can be a surrogate endpoint in place of fractures. That could be very interesting, as we know GLP-1s can cause bone loss. 5%, then that’ll be the primary endpoint with function and BMD as secondary endpoints. If incremental weight loss is less than 5%, you have 2 ways forward. 1 is a functional endpoint, and BMD or BMD alone. That’s why this trial is so critical. It’s a perfect trial because it’s measuring all these things and body composition that can inform us on what the phase III programs would look like. If you notice, all the competitors are still in phase II, working out dose, working out safety, working out, you know, which direction they’re gonna take. This is not just for enobosarm. Myostatin inhibitors, if you wanna have incremental weight loss and function and BMD, you have to measure those all separately, and they have to be separate claims. You have to make sure you have the data to do that. We’re the only company that really is focused on function with a very objective measurement. That’s why this trial will be interesting. As you know, we’ve de-risked a lot of it with the Phase II QUALITY study that we’ve done. The problem with the QUALITY study is 16 weeks, and you need more than that time to see weight loss, incremental weight loss. So we’re doing the definitive study to answer that question. To answer your second question, yes. The field is Which, just to refresh everybody’s memory, second question is, you know, if we do move forward, and we’ve got all these co-companies coming out with weight loss agents, orals and non-orals, you know, is the claim gonna be an enobosarm with any GLP-1 receptor agonist, or the studies have to be specific to the GLP-1 receptor agonist in the form or the formulation of that agonist? The answer is, my understanding is that certainly initially it’s gonna be based on the specific GLP-1 receptor agonist. That’s why it’s important for us to focus on, you know, semaglutide or initially. I think since each of these GLP-1 receptor agonists have different effects on weight loss, that you’re probably going to have to do, whether it’s us or anybody else, you’re probably going to have to combine it with the specific weight loss agent initially, and then we’ll see what happens to the field later. It may get to a point that, you know, GLP-1 alone or GLP-1 GIP alone. Initially it’s my opinion it’s going to be specific to the GLP-1 receptor agonist. K. Gary Barnette is on the call. He’s our Chief Scientific Officer. What do you think about that question, Gary? Dr. K. Gary Barnette, Chief Scientific Officer, Veru Inc.: Yeah, it’s a great question. I think that, at some point I can envision Remember, the consequence that we’re treating with enobosarm, is weight loss. Weight loss occurs with all of the GLPs and all of the incretins, and all of them will have a similar issue with the loss of lean mass and the plateau that we’re addressing in the plateau study. I think that I can see a world where we include multiple different incretins as in our phase III. Mitch is exactly correct. You know, the FDA’s longtime mantra is you get in your label what you study in your phase III. Right now, our plan is to really focus on one or two incretins in the phase III program. Leland Gershell, Analyst, Oppenheimer: Okay. Thank you. 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. Thank you, operator. I appreciate everyone who joined us on today’s call. I look forward to updating all of you on our progress on our next investor’s call. Have a great day. The digital replay of the conference call will be available beginning approximately 12:00 P.M. Eastern Time today, May 13th, by dialing 18556699658 in the U.S. and 14123170088 internationally. You will be prompted to enter the replay access code, which will be 8826955. Please record your name and company when joining. The conference call has now concluded. Thank you for attending today’s discussion. See the trade on VERU, but can't pull the trigger? Most traders can read a chart. 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© Reuters. In this article: See what 10M+ investors are talking about. Get the Stocktwits Daily Rip for what retail is watching right now, free to your inbox VERU0.00% Veru Inc. reported a substantial improvement in its Q2 fiscal year 2026 financial performance, marked by a significant reduction in net loss and operating expenses. The company’s stock saw a premarket rise of 3.52%, reflecting investor optimism. With a focus on its lead asset, enobosarm, Veru continues to drive innovation in obesity treatment. Veru’s net loss improved by 75.9% from the previous year’s quarter. R&D and SG&A expenses were significantly reduced, contributing to improved financial metrics. The company’s cash position increased by 74.7% to $27.6 million. Enobosarm shows promise in addressing weight loss plateaus in obesity treatment. Veru Inc. demonstrated a marked improvement in its financial health during Q2 FY2026. The company reduced its net loss from continuing operations to $3.1 million, a significant improvement from the $7.9 million loss reported in the same quarter the previous year. This performance reflects the company’s effective cost management and strategic focus on its core assets. With a market capitalization of $36.43 million, the biotech firm continues navigating its development phase. Net Loss from Continuing Operations: $3.1 million, a 75.9% improvement year-over-year. Total Net Loss: $2.7 million, compared to $7.9 million in the prior year quarter. R&D Costs: Decreased by 20.5% to $3.1 million. SG&A Expenses: Reduced by 21.2% to $4.1 million. Cash Position: Increased to $27.6 million from $15.8 million as of September 2025. Net Working Capital: Increased by 152.3% to $28.0 million. Veru’s stock price rose by 3.52% in premarket trading, reaching $2.35. This positive movement reflects investor confidence in the company’s strategic direction and financial improvements. The stock’s rise comes in the context of a challenging market environment, highlighting Veru’s resilience and potential growth prospects. Veru Follow Analyze VERU 2.32 0.000(0.00%) Real-time Data·09:34:29·USD 1D 1W 1M 6M 1Y 5Y Max Veru’s future guidance includes projected EPS losses for the upcoming quarters and fiscal years, with expectations of a -$0.44 EPS for Q3 FY2026 and a -$0.49 EPS for Q4 FY2026. Despite these projections, the company is optimistic about its ongoing clinical trials and product development initiatives, particularly with enobosarm.For investors seeking comprehensive analysis, Veru is one of 1,400+ US equities covered by InvestingPro’s detailed Pro Research Reports, which transform complex Wall Street data into clear, actionable intelligence through intuitive visuals and expert analysis. Dr. Mitchell Steiner, Chairman, CEO, and President, emphasized, "Our strategic focus on enobosarm positions us uniquely in the obesity treatment market, addressing critical challenges faced by current therapies." This statement underscores the company’s commitment to innovation and its potential impact on market dynamics. Regulatory Approvals: The success of enobosarm depends on favorable regulatory outcomes. Market Competition: Intense competition in the obesity treatment market could impact market share. Clinical Trial Outcomes: The ongoing Phase IIb PLATEAU trial’s results are crucial for future product development. Economic Conditions: Broader economic pressures could affect consumer spending and healthcare funding. This comprehensive analysis of Veru Inc.’s Q2 FY2026 performance highlights the company’s financial improvements and strategic focus on innovative treatments, positioning it for potential future growth in the competitive healthcare sector. Operator: Good morning, ladies and gentlemen, and welcome to Veru Inc.’s Investors Conference Call. I would now like to turn the conference over to Mr. Samuel Fisch, Veru Inc.’s Executive Director, Investor Relations and Corporate Communications. Please go ahead. Samuel Fisch, Executive Director of Investor Relations and Corporate Communications, Veru Inc.: Good morning. 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 Form 10-Q and Form 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. Dr. Mitchell Steiner, Chairman, Chief Executive Officer, and President, Veru Inc.: Good morning. With me on this morning’s call are Dr. K. Gary Barnette, the Chief Scientific Officer; Michele Greco, the Chief Financial Officer and Chief Administrative Officer; Philip Greenberg, General Counsel; and Samuel Fisch, the Executive Director of Investor Relations and Corporate Communications. Thank you for joining our second 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 disease. Our drug development program consists of two novel small molecules, enobosarm and sabizabulin. The first one, enobosarm, is an oral selective androgen receptor modulator, SARM, and it’s 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 it’s 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’ll focus on an update of the clinical development progress of enobosarm in our obesity program. We’ll also provide financial highlights for fiscal 2026 second quarter ended March 31st, 2026. GLP-1 receptor agonists 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 the significant indiscriminate loss of both lean mass and fat mass. Of the total weight loss, up to 50% is attributable to lean mass. Although GLP-1 receptor agonist treatments have resulted in substantial weight loss for many patients, the strategy for the next generation of obesity drugs should be a combination therapy with a GLP-1 receptor agonist to cause patients to only lose fat while preserving lean mass and physical function and bone mineral density for the highest quality weight reduction. Now, Veru has focused the clinical development of enobosarm for weight loss on older patients who have obesity. More specifically, the focus has been on older patients who have sarcopenic obesity, which means they have both obesity and low muscle mass and are potentially at the greatest risk for reaching a critically low muscle mass, which may lead to physical function decline when taking the currently approved GLP-1 receptor agonist. According to the European Working Group on Sarcopenia in Older People 2, sarcopenia is defined by reduced muscle strength and function as the primary diagnostic criterion, confirmed by low muscle quantity and quality, while the impaired physical performance reflects disease severity. As you can see, the working group emphasis is on physical strength and function, thus muscle loss alone does not define sarcopenia. As a consequence, we have chosen to also objectively evaluate and measure physical function by a stair climb test in the Phase II QUALITY clinical study. Now, Veru has completed the Phase 2b QUALITY clinical trial with a multicenter, double-blind, placebo-controlled, randomized dose finding clinical trial designed to evaluate safety and efficacy of enobosarm 3 milligrams, enobosarm 6 milligrams or placebo as a treatment to augment fat loss and prevent muscle loss. The efficacy dose finding active weight loss portion of the phase IIb clinical trial was completed at 16 weeks. Participants continued into a phase IIb maintenance extension study where all patients discontinued semaglutide treatment but continued receiving either placebo. As I mentioned, Veru focused on the impact of weight loss on physical function, not just lean mass in older patients with obesity in the Phase 2b QUALITY clinical study. Physical function was measured by the stair climb test, which is a common activity of daily living. Decline to physical function as measured by the stair climb test may predict in older patients a higher risk for mobility disabilities, gait difficulties, falls and bone fractures, hospitalizations, and mortality. It has been reported that stair climb power declines by 1.38% annually with aging. Now, it should be noted that the Phase IIb QUALITY clinical study is the first human study to demonstrate that the weight reduction in older patients who have obesity receiving a GLP-1 receptor agonist puts them at a higher risk for accelerated loss of lean mass with physical function decline. A pre loss as it represents loss of stair climb power that would naturally occur with aging over a 7-8-year period in older patients. In a phase IIb QUALITY study, the loss of lean mass mattered as 44.3% of patients on placebo plus semaglutide group had at least a 10% decline in stair climb power physical function at 16 weeks. What happened to the study group that received enobosarm in combination with a GLP-1 receptor agonist? In the phase IIb QUALITY clinical study, enobosarm treatment preserved lean mass, 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 alone. More specifically, the enobosarm 3 mg plus semaglutide group had a statistically significant and clinically meaningful 59.8% relative reduction in proportion of patients that lost at least 10% stair climb power compared to the placebo plus semaglutide group, and that P value is 0.0006. In the enobosarm 6 mg group, plus semaglutide, there was a 44.1% relative reduction in the proportion of patients with at least a 10% decline in stair climb 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. The next important question is can you potentially have greater weight loss by adding enobosarm to a GLP-1 receptor agonist treatment? First of all, as the Phase IIb QUALITY clinical studies demonstrated, patients receiving enobosarm had greater fat loss. Plus, if you’re able to preserve muscle and physical function with enobosarm while taking a GLP-1 receptor agonist, we would expect that more calories will be burned, which is expected to result in greater weight loss compared to a GLP-1 receptor agonist alone, especially in a longer study. Let’s turn to the current progress of our Phase IIb plateau clinical study. A common clinical and therapeutic challenge with GLP-1 receptor agonist treatments is that 88% of patients after 1 year on a GLP-1 receptor agonist hit 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 1 year. One explanation might be that the loss of muscle caused by non-selective tissue 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 that weight loss plateau. enobosarm has been shown in clinical studies to directly burn fat and to preserve muscle to increase physical function and burn more calories. By preserving muscle, appetite stays suppressed while more calories are burned, which can help to break through the weight loss plateau, leading to incremental weight reduction. Now let’s turn to the design of the Phase IIb QUALITY clinical study, which is a double-blind, placebo-controlled study to evaluate the effect of enobosarm 3 milligrams on total body weight, fat mass, lean mass, and physical function, bone mineral density, and safety in approximately 200 older patients aged greater than or equal to 65 who have obesity, BMI greater than or equal to 35, and are initiating semaglutide Wegovy GLP-1 receptor agonist treatment for weight reduction. The primary efficacy endpoint of the study is percent change from baseline in total body weight at 68 weeks. An interim analysis will be conducted at 36 weeks to assess the percent change from baseline in lean body mass and total fat mass as measured by DEXA scan. The key secondary endpoints for the overall study are total fat, total lean mass, physical function, again measured by stair climb test, mobility disability assessment, bone mineral density, and 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 to break through the weight loss plateau observed in patients receiving a GLP-1 receptor agonist treatment. To achieve clinically meaningful incremental weight reduction, as well as to preserve muscle mass and physical function by 68 weeks. The interim analysis of the clinical study will occur when all patients have been treated for 36 weeks. Now, semaglutide was selected as a GLP-1 receptor agonist for the phase IIb plateau study to build on Veru’s previous clinical experience using enobosarm in combination with semaglutide in the positive phase II QUALITY clinical study. Further, the clinical data from the phase IIb plateau clinical study using injectable semaglutide may support the use of oral semaglutide and oral enobosarm fixed dose combination in future phase III clinical studies. Contrast, there are no approved oral formulations for tirzepatide. On the March 9, 2026, we announced the enrollment of the first patients in the phase IIb plateau clinical study. I’m very pleased with the current enrollment rate, and we’re on track for results of the 36 interim analysis, which is expected in Q1 calendar year 2027. Now Veru is targeting the at-risk older patients with sarcopenic obesity. How large is that market? How about the total market for obesity? The Wall Street Journal reported last week that there are more than 1 billion people in the world with obesity. The World Health Organization estimates that there are 2.5 billion adults globally who are either overweight or obese, with the rate of adult obesity more than doubling since 1990. Right now, there are only two companies, Lilly and Novo Nordisk, that together are treating less than 2% of them. How about the total market for sarcopenic obesity? The overall prevalence of obesity and low muscle mass is almost 30 million adults in the U.S. How about the total market of patients who are 65 years and older with obesity? The prevalence of obesity in patients who are 65 years and older is 41.5% among the 47.4 million patients enrolled in Medicare Part D plans. That’s about 20 million potential patients. As you can see, taken together, the market opportunity for enobosarm in combination with GLP-1 receptor agonist in older patients with sarcopenic obesity is very large. I will now turn the call over to Michele Greco, CFO, CAO, to discuss the financial highlights. Michele. Michele Greco, Chief Financial Officer and Chief Administrative Officer, Veru Inc.: Thank you, Dr. Steiner. Let’s review the results for the 3 months ended March 31st, 2026. Research and development costs decreased to $3.1 million from $3.9 million in the prior quarter. The decrease is primarily due to wind down of the Phase IIb QUALITY clinical study for enobosarm as a treatment to augment fat loss and prevent muscle loss, which was completed during fiscal 2025. Personnel costs also decreased primarily due to the reduced share-based compensation expense. Selling, general, and administrative expenses were $4.1 million compared to $5.2 million in the prior quarter. The decrease is primarily due to a decrease in the share-based compensation expense. We recognized a gain on the sale of Antahi assets of $974,000 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 OnKinetics, which included payment of Series D preferred stock and warrants. During the current period, the increase in fair value of the equity securities received was $3.9 million as a result of the realized gain from the conversion of the preferred stock and then sale of the underlying common stock and change in the fair value of the remaining preferred stock and warrants. Favorable anti-dilution provisions triggered by the OnKinetics reverse stock split during the period contributed to the increase in the fair value. The bottom line result for continuing operations was a net loss of $3.1 million, or $0.13 per diluted common share, compared to a net loss of $7.9 million, or $0.54 per diluted common share in the prior year’s quarter. During the quarter, 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. 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. Net loss was $2.7 million or $0.12 per diluted common share, compared to a net loss of $7.9 million or $0.54 per diluted common share in the prior quarter. Turning to the results for the 6 months ended March 31st, 2026. Research and development costs decreased to $4.5 million from $9.6 million in the prior period. The decrease is primarily due to a wind down of the Phase IIb QUALITY clinical study for enobosarm as a treatment to augment fat loss and prevent muscle loss, which was completed during fiscal 2025. Personnel costs also decreased primarily due to the reduced share-based compensation expense. Selling general administrative expenses were $8.2 million compared to $10.4 million in the prior period. The decrease is primarily due to a decrease in the share-based compensation expense. We recognized a gain on the sale of the ENTADFI assets of $1.7 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 current period, the company recorded a gain of $3.8 million from the increase in the fair value of equity securities compared to a loss from the decrease in fair value of equity securities of $0.3 million in the prior period. The increase in fair value of the equity securities during the current year period is the result of a realized gain from the conversion of the OnKinetics preferred stock and sale of the underlying common stock and change in fair value of the remaining preferred stock and warrants. Favorable anti-dilution provisions triggered by the OnKinetics reverse stock split during the period contributed to the increase in fair value. The bottom line results for continuing operations was a net loss of $8.4 million or $0.39 per diluted common share, compared to a net loss of $9.6 million or $0.66 per diluted common share in the prior period. The net loss was $8.1 million or $0.38 per diluted common share, compared to a net loss of $16.8 million or $1.15 per diluted common share in the prior period. Looking at the balance sheet. As of March 31, 2026, our cash equivalents, and restricted cash balance was $27.6 million compared to $15.8 million as of September 30, 2025. On both March 31, 2026 and September 30, 2025, there was $0.1 million of restricted cash related to the sale of the FC2 Female Condom business. Our net working capital was $28 million on March 31, 2026, compared to $11.1 million on September 30, 2025. On October 31, 2025, Veru 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 share of common stock and the accompanying Series A and Series 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. The company is not profitable and has had negative cash flows from operations. Based on 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 clinical study that would be performed to assess percent change from baseline in lean body mass and fat mass as measured by DEXA scans. During the 6 months ended March 31st, 2026, we used cash of $15.1 million for operating activities, compared with $19.1 million used for operating activities in the prior period. We generated cash from investing activities of $3.5 million for the 6 months ended March 31st, 2026, compared to $18.4 million in the prior period. The cash generated during the current period represents proceeds from the sale of the OnKinetics equity securities of $3.2 million and $0.3 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 $1.7 million from the sale of Antahi assets, and proceeds of $393,000 from the sale of equity securities. Net proceeds provided by financing activities for the six months ended March 31, 2026 was $23.4 million, which were the proceeds from the sale of common stock and warrants in an underwritten public offering, net of commissions and costs. We used cash and financing activities for the 6 months ended March 31st, 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 now like to turn the call back to Dr. Steiner. Dr. Steiner? Dr. Mitchell Steiner, Chairman, Chief Executive Officer, and President, Veru Inc.: Thank you, Michele. 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’s star then one to rejoin the question queue. We will pause momentarily to assemble our roster. The first question today comes from Leland Gershell with Oppenheimer. Please go ahead. Leland Gershell, Analyst, Oppenheimer: Hey, good morning. A couple of questions from us. Assuming success in the Plateau study, would you expect to need two phase IIIs, or could you perhaps get by with one pivotal and perhaps use Plateau as supportive? Also wanted to ask in further studies with enobosarm Given the development of evolving agents for obesity, you know, some orals are coming through. Others want to know if the design would capture those agents as well. Would the ultimate label be agnostic to the primary weight loss agent? Would you need to study the specific weight loss agents to have those reflected in the indication label for an enobosarm? Thank you. Dr. Mitchell Steiner, Chairman, Chief Executive Officer, and President, Veru Inc.: Thank you, Leland Gershell. The first question is basically, if we’re successful, you know, what is the next step? Do you go to a phase III? Let’s be very clear what that means. As you know, the FDA has come back and told us that incremental weight loss of greater than 5% for the efficacy portion of the study is sort of the anchor. Okay. If you have greater than 5%, that stands on its own. If you wanna add the function benefits and the bone benefits, then you have to show those separately. You at least you’re moving forward with incremental weight loss. If your incremental weight loss is less than 5%, then you have two ways to move forward. One is physical function as a primary endpoint. The reason the phase IIb is so important is because we’re doing a lot of work on physical function to make sure that we have a very clear understanding of the phase III endpoint for physical function as a claim. Furthermore, if we’re collecting bone mineral density information, as you know, the FDA has recently reported back in December of 2025 that BMD alone can be a surrogate endpoint in place of fractures. That could be very interesting, as we know GLP-1s can cause bone loss. 5%, then that’ll be the primary endpoint with function and BMD as secondary endpoints. If incremental weight loss is less than 5%, you have 2 ways forward. 1 is a functional endpoint, and BMD or BMD alone. That’s why this trial is so critical. It’s a perfect trial because it’s measuring all these things and body composition that can inform us on what the phase III programs would look like. If you notice, all the competitors are still in phase II, working out dose, working out safety, working out, you know, which direction they’re gonna take. This is not just for enobosarm. Myostatin inhibitors, if you wanna have incremental weight loss and function and BMD, you have to measure those all separately, and they have to be separate claims. You have to make sure you have the data to do that. We’re the only company that really is focused on function with a very objective measurement. That’s why this trial will be interesting. As you know, we’ve de-risked a lot of it with the Phase II QUALITY study that we’ve done. The problem with the QUALITY study is 16 weeks, and you need more than that time to see weight loss, incremental weight loss. So we’re doing the definitive study to answer that question. To answer your second question, yes. The field is Which, just to refresh everybody’s memory, second question is, you know, if we do move forward, and we’ve got all these co-companies coming out with weight loss agents, orals and non-orals, you know, is the claim gonna be an enobosarm with any GLP-1 receptor agonist, or the studies have to be specific to the GLP-1 receptor agonist in the form or the formulation of that agonist? The answer is, my understanding is that certainly initially it’s gonna be based on the specific GLP-1 receptor agonist. That’s why it’s important for us to focus on, you know, semaglutide or initially. I think since each of these GLP-1 receptor agonists have different effects on weight loss, that you’re probably going to have to do, whether it’s us or anybody else, you’re probably going to have to combine it with the specific weight loss agent initially, and then we’ll see what happens to the field later. It may get to a point that, you know, GLP-1 alone or GLP-1 GIP alone. Initially it’s my opinion it’s going to be specific to the GLP-1 receptor agonist. K. Gary Barnette is on the call. He’s our Chief Scientific Officer. What do you think about that question, Gary? Dr. K. Gary Barnette, Chief Scientific Officer, Veru Inc.: Yeah, it’s a great question. I think that, at some point I can envision Remember, the consequence that we’re treating with enobosarm, is weight loss. Weight loss occurs with all of the GLPs and all of the incretins, and all of them will have a similar issue with the loss of lean mass and the plateau that we’re addressing in the plateau study. I think that I can see a world where we include multiple different incretins as in our phase III. Mitch is exactly correct. You know, the FDA’s longtime mantra is you get in your label what you study in your phase III. Right now, our plan is to really focus on one or two incretins in the phase III program. Leland Gershell, Analyst, Oppenheimer: Okay. Thank you. 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. Thank you, operator. I appreciate everyone who joined us on today’s call. I look forward to updating all of you on our progress on our next investor’s call. Have a great day. The digital replay of the conference call will be available beginning approximately 12:00 P.M. Eastern Time today, May 13th, by dialing 18556699658 in the U.S. and 14123170088 internationally. You will be prompted to enter the replay access code, which will be 8826955. Please record your name and company when joining. The conference call has now concluded. Thank you for attending today’s discussion. This article was generated with the support of AI and reviewed by an editor. For more information see our T&C. Stocktwits PR Desk has no position in any of the stocks mentioned in this article. StockTwits' news team content is for informational purposes only and is not intended as investment advice. For more, see our editorial policy. This article was originally published on StockTwits. Related: COIN, HOOD Stocks Jump After US Regulator Greenlights Crypto Perpetual Futures Boeing Secures New Contracts Worth Over $700M From Air Force, Defense Logistics Agency SpaceX Lands $4.16B Deal From US Space Force For Satellite Threat-Tracking System

Veru (NASDAQ:VERU) held its second-quarter earnings conference call on Wednesday. Below is the complete transcript from the call. Benzinga APIs provide real-time access to earnings call transcripts and financial data. Visit https://www.benzinga.com/apis/ to learn more. Access the full call at https://event.choruscall.com/mediaframe/webcast.html?webcastid=ahV4ezuY Veru is focusing on developing innovative medicines for cardiometabolic and inflammatory diseases, specifically targeting older patients with obesity and sarcopenic obesity. The company completed a positive Phase 2b clinical trial showing that combining Anovasarm with GLP1 receptor agonists leads to greater fat loss and preserves lean mass and physical function. Financial highlights for the quarter included a decrease in R&D and administrative expenses, resulting in a net loss of $3.1 million compared to a $7.9 million loss in the previous year. The company completed a public offering, raising approximately $23.4 million, which provides sufficient funds to support operations beyond the interim analysis of the Phase IIb clinical study. Veru targets a large market opportunity with over 1 billion people globally having obesity and significant proportions of older adults at risk for sarcopenic obesity. 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 over to Mr. Sam Fish, Veru Inc. Executive Director, Investors Relations and Corporate Communications. Please go ahead. Sam Fish (Executive Director, Investor Relations and Corporate Communications) Good morning. 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 or 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 10Q and 10K 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's chairman, CEO and president. Good Morning. With me on this Morning's call are Dr. Gary Barnett, the Chief Scientific Officer, Michelle Greco, the Chief Financial Officer and Chief Administrative Officer Phil Greenberg, General Counsel and Sam Fish, the Executive Director of Investor Relations and Corporate Communications. Thank you for joining our second 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. Our drug development program consists of two novel 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 plaque inflammation to slow the progression or promote the regression of atherosclerotic cardiovascular disease. This morning we'll focus on an update of the clinical development progress of the NovoSarm and in our obesity program. We will also provide financial Highlights for Fiscal 2026 Second Quarter Ended March 31, 2026 GLP-1 receptor agonists have been shown to produce significant weight loss in patients who are overweight or have obesity. Unfortunately, this weight loss is tissue nonselective with the significant indiscriminate loss of both lean mass and fat mass. Of the total weight loss up to 50% is attributable to lean mass although GLP-1 receptor agonist treatments have resulted in substantial weight loss for many patients, the strategy for the next generation of obesity drugs should be a combination therapy with a GLP-1 receptor agonist to cause patients to only lose fat while preserving lean mass and physical function and bone mineral density for the highest quality weight reduction. Now Vero has focused the clinical development of the NovoSorm for weight loss on older patients who have obesity. More specifically, the focus has been on older patients who have sarcopenic obesity which means they have both obesity and low muscle mass and are potentially at the greatest risk for reaching a critically low muscle mass which which may lead to physical function decline when taking the currently approved GLP-1 receptor agonist. According to the European Working Group on Sarcopenia in Older People too, sarcopenia is defined by reduced muscle strength and function as the primary diagnostic criterion confirmed by low muscle quantity and quality, while the impaired physical performance reflects disease severity. As you can see, the working group emphasis is on physical strength and function. Thus muscle loss alone does not define sarcopenia. As a consequence, we have chosen to also objectively evaluate and measure physical function by stair climb test in the phase 2 quality clinical study. Vero's completed phase 2b quality clinical trial was a multicenter double blind placebo controlled randomized those finding clinical trial designed to evaluate safety and efficacy of anovosarm 3mg inovosarm 6mg or placebo as a treatment to augment fat loss and prevent muscle loss in 168 older patients as greater than or equal to 60 years of age receiving semaglutide wegovy for weight reduction after the efficacy dose finding active weight loss portion of the phase 2b clinical trial was completed at 16 weeks. Participants continued into a phase IIb maintenance extension study where all patients discontinued semaglutide treatment but continue receiving either placebo novosome 3mg inovosome 6mg as monotherapy in a double blind fashion for 12 weeks. Phase 2b quality clinical trial was a positive study that demonstrated that preserving lean mass and physical function with a Noble SERM plus semaclotide led to greater fat loss. As I mentioned, Veru focused on the impact of weight loss on physical function, not just lean mass in older patients with obesity. In the Phase IIb quality clinical study, physical function was measured by the stair climb test which is a common activity of daily living declines in physical function as measured by cessations and mortality. It has been reported that stereocline power declines by 1.38% annually with aging. Now it should be noted that the phase 2b quality clinical study is the first human study to demonstrate that the weight reduction in older patients who have obesity receiving a GLP-1 receptor agonist puts them at high risk for accelerated loss of lean mass with physical function decline. A prespecified responders analysis was conducted using a greater than 10% decline in stereocline power as a cutoff at 16 weeks, which is a significant loss as it represents loss of stair climb power that would naturally occur with aging over a seven to eight year period in older patients. In a phase IIb quality study, the loss of lean mass mattered as 44.3% of patients on placebo placemaglutide group had at least a 10% decline in stair climb power physical function at 16 weeks. And what happened to the study group that received anovasarm in combination with the GLP-1 receptor agonist? In the phase 2b quality clinical study, innovasarm treatment preserved lean mass which translated into a reduction in the proportion portion of patients. The Inovasarm 3 milligram plus somaglutide group had a statistically significant and clinically meaningful 59.8% relative reduction in proportion of patients that lost at least 10% stair climb power compared to the placebo plus semaglutide group and that P value is 0.0006. In the anovasome 6 milligram group plus semaglutide there was a 44.1% relative reduction in the port portion of patients with at least a 10% decline in stereocline power from baseline versus placebo plus semaglutide group and that P value is 0.051. Based on the results of this short term 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 and at risk older patients with sarcopenic obesity receiving a GLP-1 receptor agonist for weight reduction. The next important question is can you potentially have greater weight loss by adding a novus arm to a GLP-1 receptor agonist treatment? First of all, as the phase 2b quality clinical studies demonstrated, patients receiving a novus arm had greater fat loss plus if you're able to observe muscle and physical function with ANOVA SERM While taking a GLP-1 receptor agonist, we would expect that more calories will be burned which is expected to result in greater weight loss compared to GLP-1 receptor agonists alone, especially in a longer study. Now let's turn to the current progress of our phase 2b plateau clinical study. A common clinical and therapeutic challenge with GLP-1 receptor agonist treatments is that 88% of patients after one year on a GLP-1 receptor agonist hit a weight loss plateau where they stop losing additional weight. Based on the Sermont one study conducted by Eli Lilly, one explanation might be that the loss of muscle caused by non selective tissue 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 that weight loss plateau again. Novusart has been shown in clinical studies to directly burn fat and to preserve muscle to increase physical function and burn more calories. Thus, by preserving muscle, appetite stays suppressed while more calories are burned which can help to break through the weight loss plateau leading to incremental weight reduction. Now let's turn to the Design of the Phase 2b Plateau Clinical Study which is a double blind placebo controlled study to evaluate the effect of anovasome 3mg on total body mass, excuse me, 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, BMI greater or equal to 35 and are initiating semaglutide GOVI GLP-1 receptor agonist treatment for weight reduction. The primary efficacy endpoint of the study is a percent change of baseline in total body weight at 68 weeks. Interim analysis will be conducted at 36 weeks to assess the percent change in baseline lean body mass and total fat mass as measured by DEXA scale. The key secondary endpoints for the overall study are total fat, total lean mass, physical function again measured by stair climb test, mobility disability assessment, bone mineral density and patient reported outcome questionnaires for physical function, HbA1c and insulin resistance. 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. The phase 2b plateau clinical study will also assess the ability of inovasone to break through the weight loss plateau observed in patients receiving the GLP-1 receptor agonist treatment to achieve clinically meaningful incremental weight reduction as well as to preserve muscle mass and physical function by 68 weeks. The interim analysis of the clinical study study will occur when all patients have been treated for 36 weeks. Now, semaglutide was selected as a GLP-1 receptor agonist for the phase 2 but study to build on Viru's previous clinical experience using inovasarm in combination with semaglutide in the positive phase 2 quality clinical study. Further, the clinical data from the Phase IIb plateau clinical study using injectable semaglutide may support the use of oral semaglutide and oral Inovisarm fixed dose combination in future phase 3 clinical studies. Contrast, there are no approved oral formulations with tirzepatide. On March 9, 2026 we announced the enrollment of the first patient into Phase 2b plateau clinical study. I'm very pleased with the current enrollment rate and we're on track for results of the 36 interim analysis which is expected in Q1 calendar year 2027. Now Vero is targeting the at-risk older patients with sarcopenic obesity. So how large is that market? How about the total market for obesity? The Wall Street Journal reported last week that there are more than 1 billion people in the world with obesity. The World Health Organization estimates that there are two and a half billion adults globally who are either overweight or obese, with the rate of adult obesity more than doubling since 1990. And right now there are only two companies, Lilly and Novo Nordisk, that together are treating less than 2% of them. How about the total market for sarcopenic obesity? The overall prevalence of obesity and low muscle mass is almost 30 million adults in the US. How about the total market of patients who are 65 years and older with obesity? The prevalence of obesity in patients who are 65 years and older is 41.5% among the 47.4 million patients enrolled in Medicare Part D plans. That's about 20 million potential patients. As you can see. Taken together, the market opportunity for Inovus arm in combination of GLP-1 receptor agonists in older patients with sarcopenic obesity is very large. I will now turn the call over to Michelle Greco, CFO Cao, to discuss the financial highlights. Michelle Greco (Chief Financial Officer and Chief Administrative Officer) Michelle thank you, Dr. Steiner. Let's review the results for the three months ended March 31, 2026. Research and development costs decreased to $3.1 million from $3.9 million in the prior quarter. The decrease is primarily due to wind down of the phase 2b quality clinical study for NovoSarm as a treatment to augment fat loss and prevent muscle loss, which was completed during fiscal 2025. Personnel costs also decreased primarily due to the reduced share based compensation expense. Selling general and Administrative expenses were $4.1 million compared to $5.2 million in the prior quarter. The decrease is primarily due to a decrease in the share based compensation expense. We recognize the gain on the sale of enthe assets of $974,000 in the prior year's quarter which is based on non refundable consideration received related to promissory notes previously due to verus. 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 Oncogenetics which included payment of Series D preferred stock and warrants. During the current period, the increase in fair value of the equity securities received was $3.9 million as a result of the realized gain from the conversion of the preferred stock and then sale of the underlying common stock and change in the fair value of the remaining preferred stock and warrants. Favorable anti-dilution provisions triggered by the Oncogenetics reverse stock split during the period contributed to the increase in the fair value. The bottom line result for continuing operations was a Net loss of $3.1 million or $0.13 per diluted common share compared to a Net loss of $7.9 million or $0.54 per diluted common share in the prior year's quarter. During the quarter, 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 the dispute related to a pre closing tax receivable and liability which is included as income from discontinued operations in the prior year period. Veru sold the FC2 Female Condom business to Clear Future in our financial statements, all direct revenues, cost and expenses related to the FC2 Female Condom business are classified within Loss from Discontinued Operations Net of Tax in the Statement of Operations, net loss was $2.7 million or $0.12 per diluted common share compared to a Net loss of $7.9 million or $0.54 per diluted common share in the prior quarter. Now turning to the Results for the six months ended March 31, 2026, research and development costs decreased to $4.5 million from $9.6 million in the prior period. The decrease is primarily due to a wind down of the phase 2b quality clinical study for Novaserm as a treatment to augment fat loss and prevent muscle loss which was completed during fiscal 2025. Personnel costs also decreased primarily due to the reduced share based compensation expense. Selling general Administrative expenses were $8.2 million compared to $10.4 million in the prior period. The decrease is primarily due to a decrease in the share based compensation expense. We recognize the gain on the sale of the INDAF assets of $1.7 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 current period, the Company recorded a gain of $3.8 million from the increase in the fair value of equity securities compared to a loss from the decrease in fair value of Equity securities of $0.3 million in the prior period. The increase in fair value of the equity securities during the current year period is the result of a realized gain from the conversion of the Oncogenetics preferred stock stock and sale of the underlying common stock and change in fair value of the remaining preferred stock and warrants. Favorable anti-dilution provisions triggered by the Oncogenetics reverse stock split during the period contributed to the increase in fair value. The bottom line results for continuing operations was a Net loss of $8.4 million or $0.39 per diluted common share compared to a Net loss of $9.6 million or $0.66 per diluted common share in the prior period. The net loss was $8.1 million or $0.38 per diluted common share compared to a Net loss of $16.8 million or $1.15 per diluted common share in the prior period. Looking at the balance sheet as of March 31, 2026, our cash cash equivalents and restricted cash balance was $27.6 million compared to $15.8 million as of September 30, 2025. On both March 31, 2026 and September 30, 2025, there was $0.1 million of restricted cash related to the sale of the FC2 Female Condom business. Our net working capital was $28 million on March 31, 2026 compared to $11.1 million on September 30, 2025. On October 31, 2025, Veru 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 share of common stock and the accompanying Series A and Series 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. The Company is not profitable and has had negative cash flows from operations based on 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 clinical study that would be performed to assess percent change from baseline in lean body mass and fat mass as measured by DEXA Scan. During the 6 months ended March 31, 2026, we used cash of $15.1 million for operating activities compared with $19.1 million used for operating activities in the prior period. We generated cash from investing activities of $3.5 million for the six months ended March 31, 2026 compared to $18.4 million in the prior period. The cash generated during the current period represents proceeds from the sale of the onconnects equity securities of $3.2 million and $0.3 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 $1.7 million from the sale of enthe assets and proceeds of $393,000 from the sale of equity securities. Net proceeds provided by financing activities for the six months ended March 31, 2026 was $23.4 million which were the proceeds from the sale of common stock and warrants in an underwritten public offering net of commissions and costs. We used cash and financing activities for the six months ended March 31, 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 now like to turn the call back to Dr. Steiner. Dr. Steiner. Dr. Mitchell Steiner (Chairman, CEO and President) Thank you, Michelle. With that I'll now open the call to questions. Operator 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's star, then one to rejoin the question queue. We will pause momentarily to assemble our roster. The first question today comes from Leland Gershel with Oppenheimer. Please go ahead. Leland Gershel Hey, good morning. Couple questions from us. Assuming success in the plateau study, would you expect to need two phase 3s or could you perhaps get by with one pivotal and perhaps use plateau supporters and also wanted to ask in further studies with NovoSarm given the development of evolving agents for obesity as an orals are coming through, others want to know if the design would capture those agents as well. With the ultimate label diagnostic to the primary weight loss agent, would you need to study the specific weight loss agents to indication label for inovasone? Dr. Mitchell Steiner (Chairman, CEO and President) so thank you Leland. So the first question is basically if we're successful, what is the next step? And you go to phase three. So let's be very clear what that means. As you know, the FDA has come back and told us that incremental weight loss of greater than 5% for the efficacy portion of the study is sort of the anchor. Okay, so you have greater than 5% that stands on its own. If you want to add the function benefits and the bone benefits, then you have to show those separately. But you least you're moving forward with incremental weight loss. If your incremental weight loss is less than 5%, then you have two ways to move forward. One is physical function as a primary endpoint. And the reason the phase IIB is so important is because we're doing a lot of work on physical function to make sure that we have a very clear understanding of the Phase 3 endpoint for physical function as a claim. And furthermore, we're collecting bone mineral density information. As you know, the FDA has recently reported back in December of 2025 that BMD alone can be a surrogate endpoint in place of fractures. And so that could be very interesting is we know GLP-1s can cause bone loss in this patient population undergoing this accelerated weight loss. So if the incremental weight loss is greater than 5%, then that will be the primary endpoint with function and BMD secondary endpoints. If incremental weight loss is less than 5%. That's why this trial is so critical. Critical. It's a perfect trial because it's measuring all these things in body composition that can inform us on what if they working out which direction they're going to take. So this is not just for a NovoSarm Myostatin inhibitors. If you want to have incremental weight loss and function and bmd, you have to measure those all separately and they have to be separate claims and you have to make sure you have the data to do that. We're the only company that really is focused on function with a very objective measurement. So that's why this trial will be interesting. As you know, we've de risked a lot of it with the phase two quality study that we've done. But the problem with the quality study is 16 weeks and you need more than that time to see weight loss, incremental weight loss. And, and so we're doing the definitive study to answer that question. To answer your second question, yes, the field is just to refresh everybody's memory. Second question is if we do move forward and we've got all these companies coming out with weight loss agents, orals and non orals, is the claim going to be a Novus arm with any GLP-1 receptor agonist or. The studies have to be specific to the GLP-1 receptor agonist in the form of the formulation of that agonist. And the answer is, my understanding is certainly initially it's going to be based on the specific GLP-1 receptor agonist. So that's why it was important for us to focus on, you know, semaglutide initially. But I think since each of these have different, each of these GLP-1 receptor agonists have different effects on weight loss that you're probably going to have to do, whether it's us or anybody else is probably going to have to combine it with the specific weight loss agent initially and then we'll see what happens with the field later. It may get to a point that GLP-1 alone or GLP-1 GIP-1 alone, but initially my opinion is going to be specific to the GLP-1 receptor agonist. Now, Gary Barnett is on the call, he's our chief scientific officer. What do you think about that question, Gary? Gary Barnett Yeah, it's a great question. I think that at some point I can envision, remember the consequence that we're treat. Treating with NovoSarm is weight loss. And weight loss occurs with all of the GLP-1s and all of the incretins, and all of them will have a similar issue with the loss of lean mass and the plateau that we're addressing in the plateau study. I think that I can see a world where we include multiple different incretins, as in our phase three. But Mitch is exactly correct. You know, the FDA's longtime mantra is you get in your label what you study in your Phase three. So right now our plan is to really focus on one or two incretins, in the Phase 3 program. Okay, thank you, 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. Dr. Mitchell Steiner (Chairman, CEO and President) Thank you, operator. I appreciate everyone who joined us on today's call and I look forward to updating all of you on our progress on our next investors call. Have a great day. OPERATOR The digital replay of the conference call will be available beginning approximately 12:00pm Eastern Time today, May 13th by dialing 1-855-669-9658 in the U.S. and 1-412-317-0088 internationally. You will be prompted to enter the replay access code, which will be 882-6955. Please record your name and company when joining. Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company's SEC filings and official press releases. Corporate participants' and analysts' statements reflect their views as of the date of this call and are subject to change without notice. Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. This article Transcript: Veru Q2 2026 Earnings Conference Call originally appeared on Benzinga.com © 2026 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

This article first appeared on GuruFocus. Release Date: May 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Veru Inc (NASDAQ:VERU) has completed a positive Phase IIb clinical trial demonstrating that their drug, enovasarm, combined with a GLP-1 receptor agonist, preserves lean mass and enhances fat loss in older patients with obesity. The company is targeting a large market opportunity with over 1 billion people globally affected by obesity, and a significant portion of these are older adults with sarcopenic obesity. Research and development costs have decreased, indicating efficient management of resources as the Phase IIb clinical study winds down. Veru Inc (NASDAQ:VERU) has a strong cash position with $27.6 million in cash equivalents and restricted cash, providing a financial cushion for ongoing operations. The company successfully raised $23.4 million through a public offering, enhancing its financial stability and ability to fund future clinical studies. Veru Inc (NASDAQ:VERU) reported a net loss of $3.1 million for the quarter, indicating ongoing financial challenges. The company is not yet profitable and continues to experience negative cash flows from operations. There is uncertainty regarding the need for additional Phase III studies, which could delay the commercialization of their drug. The market for obesity treatments is competitive, with only two companies currently treating a small percentage of the global population, posing a challenge for Veru Inc (NASDAQ:VERU) to capture market share. The company's future success is heavily dependent on the outcomes of ongoing and future clinical trials, which carry inherent risks and uncertainties. Warning! GuruFocus has detected 2 Warning Signs with VERU. Is VERU fairly valued? Test your thesis with our free DCF calculator. Q: Assuming success in the PLATO study, would you expect to need two Phase III studies, or could you apply with one pivotal study and use PLATO as support? Also, would the ultimate label for Anobosarm be agnostic to the primary weight loss agent, or would you need to study specific agents to have them reflected in the indication label? A: Dr. Mitchell Steiner, CEO, explained that if the incremental weight loss is greater than 5%, it stands on its own for efficacy. If less than 5%, physical function or bone mineral density (BMD) could be primary endpoints. The FDA requires specific studies for each GLP-1 receptor agonist, so initially, the label would be specific to the studied agent, like semaglutide. Dr. Gary Barnett, Chief Scientific Officer, added that while multiple incretins could be included in Phase III, the FDA typically requires specific studies for label claims. Q: What is the significance of the Phase IIb quality clinical study results for Veru's obesity program? A: Dr. Mitchell Steiner highlighted that the Phase IIb study demonstrated that Enobosarm, combined with semaglutide, preserved lean mass and physical function, leading to greater fat loss. This is crucial for older patients with sarcopenic obesity, as it addresses the risk of accelerated lean mass loss and physical function decline when using GLP-1 receptor agonists. Q: Can you elaborate on the market opportunity for Enobosarm in combination with GLP-1 receptor agonists? A: Dr. Mitchell Steiner noted that the market for obesity treatment is vast, with over 1 billion people globally affected. The specific market for older patients with sarcopenic obesity is significant, with nearly 30 million adults in the U.S. alone. The combination of Enobosarm with GLP-1 receptor agonists targets a large unmet need in this demographic. Q: How does Veru plan to address the weight loss plateau observed with GLP-1 receptor agonists? A: Dr. Mitchell Steiner explained that Enobosarm has been shown to preserve muscle and increase physical function, which can help break through the weight loss plateau by burning more calories and maintaining appetite suppression. This approach aims to achieve incremental weight reduction beyond what GLP-1 receptor agonists alone can offer. Q: What are the financial highlights for Veru's second quarter of fiscal 2026? A: Michelle Greco, CFO, reported a decrease in research and development costs to $3.1 million and selling, general, and administrative expenses to $4.1 million. The net loss for continuing operations was $3.1 million, or $0.13 per diluted share, compared to a net loss of $7.9 million in the prior year's quarter. The company has a cash balance of $27.6 million, sufficient to fund operations beyond the interim analysis of the Phase IIb clinical study. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

--Phase 2b PLATEAU clinical study evaluating enobosarm + semaglutide is actively enrolling and on track for interim analysis first quarter calendar year 2027— --Company to host conference call and webcast today at 8:00 a.m. ET— MIAMI, FL, May 13, 2026 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, today announced financial results for its fiscal 2026 second quarter ended March 31, 2026, and provided a corporate update. "We are extremely pleased with the progress of the enrollment of the Phase 2b PLATEAU clinical trial to evaluate the effect of enobosarm 3mg on total body weight, fat mass, lean mass, physical function, bone mineral density and safety in older patients who have obesity and receiving a semaglutide GLP-1 RA treatment for weight reduction. We are on track for presenting the results of the interim analysis which is expected in Q1 calendar year 2027,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru Inc. Veru Obesity Program – Study of Enobosarm in combination with GLP-1 RA for higher quality weight reduction Phase 2b PLATEAU Clinical Study – Actively enrollingPhase 2b PLATEAU clinical trial is a double-blind, placebo-controlled study to evaluate the effect of enobosarm 3mg on total body weight, fat mass, lean mass, physical function, bone mineral density and safety in approximately 200 older patients (age ≥ 65 years) who have obesity (BMI ≥ 35) and are initiating semaglutide treatment for weight reduction. The Phase 2b PLATEAU study is designed to assess the ability of enobosarm treatment to break through the weight loss plateau observed in patients with obesity receiving GLP-1 RA treatment by preserving muscle mass and physical function to achieve clinically meaningful incremental weight reduction by 68 weeks. The primary efficacy endpoint of the study is the percent change from baseline in total body weight at 68 weeks. An interim analysis will be conducted at 36 weeks to assess the percent change from baseline in lean body mass and fat mass, as measured by DXA scan. The key secondary endpoints are total fat mass, total lean mass, physical function (stair climb test), mobility disability assessment, bone mineral density, and patient reported outcome questionnaires for physical function, HbA1c, and insulin resistance. Semaglutide was selected as the GLP-1 RA for the Phase 2b PLATEAU study to build on Veru’s previous clinical experience using enobosarm in combination with semaglutide in the positive Phase 2 QUALITY clinical study. Further, the clinical data from the Phase 2b PLATEAU clinical trial using injectable semaglutide may support the use of oral semaglutide in combination with oral enobosarm in future Phase 3 clinical studies. In contrast, there is no approved oral formulation for tirzepatide. The Principal Investigator for the Phase 2b PLATEAU clinical trial is Steven Heymsfield, MD, a Professor and the Director of the Body Composition-Metabolism Laboratory at the Pennington Biomedical Research Center in Baton Rouge, Louisiana. Dr. Heymsfield was also the Principal Investigator of Veru’s Phase 2 QUALITY clinical study. An interim analysis to assess change in lean body mass and fat mass as measured by DXA will be conducted at 36 weeks with data expected in the first quarter of calendar year 2027. Final topline clinical data is expected in the fourth quarter of calendar year 2027. Phase 2b QUALITY Clinical Study – Completed The Phase 2b QUALITY clinical study was a positive multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial designed to evaluate the safety and efficacy of enobosarm 3 mg, enobosarm 6 mg, or placebo as a treatment to augment fat loss and to prevent muscle loss in 168 older patients (≥60 years of age) receiving semaglutide (Wegovy®) for weight reduction. After the efficacy dose-finding portion of the Phase 2b QUALITY clinical trial was completed at 16 weeks, participants continued into a Phase 2b maintenance extension study where all patients discontinued semaglutide treatment, but continued receiving placebo, enobosarm 3 mg, or enobosarm 6 mg as monotherapy in a double-blind fashion for 12 weeks. The Phase 2b QUALITY and Maintenance Extension clinical trial was a positive study that demonstrated that preserving lean mass and physical function with enobosarm plus semaglutide led to greater fat loss during the 16 week active weight loss period. While weight loss was similar across treatment groups in this short 16 week study, we anticipate that preservation of lean mass and function will lead to increased energy expenditure, and this effect coupled with the direct effects of enobosarm on the additional selective reduction in fat mass will result in incremental weight reduction in a longer 68 week clinical study in patients who have obesity. Second Quarter Financial Summary: Fiscal 2026 vs Fiscal 2025 Research and development expenses decreased to $3.1 million from $3.9 million General and administrative expenses decreased to $4.1 million from $5.2 million Operating loss from continuing operations decreased to $7.2 million from $8.1 million Net loss decreased to $2.7 million, or $0.12 per share, compared to $7.9 million, or $0.54 per share Year-to-Date Financial Summary: Fiscal 2026 vs Fiscal 2025 Research and development expenses decreased to $4.5 million from $9.6 million General and administrative expenses decreased to $8.2 million from $10.4 million Operating loss from continuing operations decreased to $12.6 million from $18.4 million Net loss decreased to $8.1 million, or $0.37 per share, compared to $16.8 million, or $1.15 per share Balance Sheet Information ​​​​​Cash, cash equivalents and restricted cash were $27.6 million as of March 31, 2026 versus $15.8 million as of September 30, 2025 Event DetailsThe audio webcast will be accessible under the Home page and Investors page of the Company’s website at www.verupharma.com. To join the conference call via telephone, please dial 1-800-341-1602 (domestic) or 1-412-902-6706 (international) and ask to join the Veru Inc. call. An archived version of the audio webcast will be available for replay on the Company’s website for approximately three months. A telephonic replay will be available at approximately 12:00 p.m. ET by dialing 1-855-669-9658 (domestic) or 1-412-317-0088 (international), passcode 8826955, for one week. About Veru Inc.Veru is a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases. The Company’s drug development program includes two late-stage novel small molecules, enobosarm and sabizabulin. Enobosarm, an oral selective androgen receptor modulator (SARM), is being developed as a next generation drug that makes weight reduction by GLP-1 RA drugs more tissue selective for loss of fat and preservation of lean mass to improve body composition and physical function which is expected to result in clinically meaningful incremental weight reduction versus GLP-1 RA therapy alone. Sabizabulin, a microtubule disruptor, is being developed for the treatment of chronic inflammation related to atherosclerotic cardiovascular disease. Forward-Looking StatementsThis press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, express or implied statements related to the planned design, enrollment, timing, commencement, interim, topline and full data readout timing, scope and regulatory pathways for the continued development of enobosarm in patients with obesity, including the PLATEAU Phase 2b study; the planned design, number of sites, timing, endpoints, patient population and patient size of such trial and whether the PLATEAU trial will successfully meet any of its primary or secondary endpoints; whether the results of the Phase 2b QUALITY study and the extension maintenance study of enobosarm, including weight loss, preservation of lean mass and physical function and loss of fat mass, will be replicated to the same or any degree in the PLATEAU Phase 2b study or in any future Phase 3 studies; whether and when the PLATEAU Phase 2b study of enobosarm will produce an interim analysis and/or topline data; whether enobosarm in combination with a GLP-1 RA drug will provide a higher quality and/or greater quantity weight loss in patients and whether this combination therapy will be the next generation drug that makes weight reduction more tissue selective for loss of fat, preservation of lean mass and physical function, improved body composition and maintaining or increasing bone mineral density; whether patients treated with enobosarm in the PLATEAU Phase 2B study will preserve lean mass and physical function leading to an increased use of energy and whether such effects will result in incremental weight reduction; whether patients treated with enobosarm in the PLATEAU Phase 2B study will break through the weight loss plateau and achieve clinically meaningful incremental weight reduction by preserving muscle mass and physical function; and whether the oral form of semaglutide may be used in combination with enobosarm in future Phase 3 clinical studies and whether the injectable semaglutide used in the PLATEAU Phase 2B study data of enobosarm will support the use of oral semaglutide formulation in combination with oral enobosarm in future Phase 3 clinical studies; The words "anticipate," "believe," "could," "expect," "intend," "may," "opportunity," "plan," "predict," "potential," "estimate," "should," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based upon current plans and strategies of the Company and reflect the Company's current assessment of the risks and uncertainties related to its business and are made as of the date of this press release. The Company assumes no obligation to update any forward-looking statements contained in this press release because of new information or future events, developments, or circumstances. Such forward-looking statements are subject to known and unknown risks, uncertainties and assumptions, and if any such risks or uncertainties materialize or if any of the assumptions prove incorrect, our actual results could differ materially from those expressed or implied by such statements. Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to: the development of the Company’s product portfolio and the results of clinical studies, including any interim or topline analysis, possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; although the Company has sought and received feedback from the FDA on the designs of its clinical trials and intends to continue to do so, the FDA may ultimately disagree that the Company’s clinical trials support approval; the Company’s ability to reach agreement with FDA on study design requirements for the Company’s planned clinical studies, including for the Phase 2b program for enobosarm as a weight loss or body composition drug and the number of future Phase 3 studies to be required and the cost thereof; potential delays in the timing of and results from clinical trials and studies, including as a result of an inability to enroll sufficient numbers of subjects in clinical studies or an inability to enroll subjects in accordance with planned schedules; the ability to fund planned clinical development as well as other operations of the Company; the Company plans to prioritize the use of its current internal cash to the development of enobosarm, with a primary near-term focus on funding its PLATEAU Phase 2b clinical trial, and as a result advancement of sabizabulin as a treatment for slowing progression of or promoting regression of atherosclerosis disease will depend upon the Company securing additional funding; whether the Company will be able to partner with another company in the development of enobosarm or sabizabulin; the timing of any submission to the FDA or any other regulatory authority and any determinations made by the FDA or any other regulatory authority; the potential for disruptions at the FDA or other government agencies to negatively affect our business, including as a result of a future shutdown of the U.S. government; any products of the Company, if approved, possibly not being commercially successful; the ability of the Company to obtain sufficient financing, including any partnership or collaboration agreements, on acceptable terms when needed to fund development and operations and to enable us to continue as a going concern; the effect of the SEC’s “baby shelf” rules on the Company’s ability to raise sufficient capital when needed; demand for, market acceptance of, and competition against any of the Company’s products or product candidates; new or existing competitors with greater resources and capabilities and new competitive product approvals and/or introductions; changes in regulatory practices or policies or government-driven healthcare reform efforts, including pricing pressures and insurance coverage and reimbursement changes; the Company’s ability to protect and enforce its intellectual property; costs and other effects of litigation, including regulatory challenges, product liability claims, intellectual property, securities litigation and litigation with the purchaser of the Company’s FC2 business; the Company’s ability to identify, successfully negotiate and complete suitable acquisitions or other strategic initiatives; the Company’s ability to successfully integrate acquired businesses, technologies or products; and other risks detailed from time to time in the Company’s press releases, shareholder communications and Securities and Exchange Commission filings, including the Company's Form 10-K for the year ended September 30, 2025, and subsequent quarterly reports on Form 10-Q. These documents are available on the “SEC Filings” section of our website at www.verupharma.com/investors.Wegovy® is a registered trademark of Novo Nordisk A/S. Investor and Media Contact: Samuel FischExecutive Director, Investor Relations and Corporate CommunicationsEmail: [email protected]

MIAMI, FL, May 06, 2026 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, today announced it will host a conference call and audio webcast on Wednesday, May 13, 2026, at 8:00 a.m. ET to discuss its fiscal 2026 second quarter financial results and to provide a business update. The audio webcast will be accessible under the Home page and Investors page of the Company’s website at www.verupharma.com. To join the conference call via telephone, please dial 1-800-341-1602 (domestic) or 1-412-902-6706 (international) and ask to join the Veru Inc. call. An archived version of the audio webcast will be available for replay on the Company’s website for approximately three months. A telephonic replay will be available at approximately 12:00 p.m. ET by dialing 1-855-669-9658 (domestic) or 1-412-317-0088 (international), passcode 8826955, for one week. About Veru Inc. Veru is a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases. The Company’s drug development program includes two late-stage novel small molecules, enobosarm and sabizabulin. Enobosarm, an oral selective androgen receptor modulator (SARM), is being developed as a next generation drug that makes weight reduction by GLP-1 RA drugs more tissue selective for loss of fat and preservation of lean mass to improve body composition and physical function which is expected to result in clinically meaningful incremental weight reduction versus GLP-1 RA therapy alone. Sabizabulin, a microtubule disruptor, is being developed for the treatment of chronic inflammation related to atherosclerotic cardiovascular disease. Enobosarm Obesity Program - Enobosarm is a next generation drug that in combination with GLP-1 RA results in higher quality weight reduction Phase 2b PLATEAU Clinical Study – Enrolling Veru’s Phase 2b PLATEAU clinical trial is a double-blind, placebo-controlled study to evaluate the effect of enobosarm 3mg on total body weight, fat mass, lean mass, physical function, bone mineral density and safety in approximately 200 older patients (age ≥ 65 years) who have obesity (BMI ≥ 35) and are initiating semaglutide treatment for weight reduction. The Phase 2b PLATEAU study is designed to assess the ability of enobosarm treatment to break through the weight loss plateau observed in patients with obesity receiving semaglutide treatment by preserving muscle mass and physical function to achieve clinically meaningful incremental weight reduction. The primary efficacy endpoint of the study is the percent change from baseline in total body weight at 68 weeks. An interim analysis will be conducted at 36 weeks to assess the percent change from baseline in lean body mass and fat mass, as measured by DXA scan. The key secondary endpoints are total fat mass, total lean mass, physical function (stair climb test), mobility disability assessment, bone mineral density, and patient reported outcome questionnaires for physical function, HbA1c, and insulin resistance. Semaglutide was selected as the GLP-1 RA for the Phase 2b PLATEAU study to build on Veru’s previous clinical experience using enobosarm in combination with semaglutide in the positive Phase 2 QUALITY clinical study. Further, the clinical data from the Phase 2b PLATEAU clinical trial using injectable semaglutide may support the use of oral semaglutide in combination with oral enobosarm in future Phase 3 clinical studies. In contrast, there is no approved oral formulation for tirzepatide. The Principal Investigator for the Phase 2b PLATEAU clinical trial is Steven Heymsfield, MD, a Professor and the Director of the Body Composition-Metabolism Laboratory at the Pennington Biomedical Research Center in Baton Rouge, Louisiana. Dr. Heymsfield was also the Principal Investigator of Veru’s Phase 2 QUALITY clinical study. An interim analysis to assess change in lean body mass and fat mass as measured by DXA will be conducted at 36 weeks with data expected in the first quarter of calendar year 2027. Final topline clinical data is expected in the fourth quarter of calendar year 2027. Phase 2b QUALITY Clinical Study – Completed The Phase 2b QUALITY clinical study was a positive multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial designed to evaluate the safety and efficacy of enobosarm 3 mg, enobosarm 6 mg, or placebo as a treatment to augment fat loss and to prevent muscle loss in 168 older patients (≥60 years of age) receiving semaglutide (Wegovy®) for weight reduction. After the efficacy dose-finding portion of the Phase 2b QUALITY clinical trial was completed at 16 weeks, participants continued into a Phase 2b maintenance extension study where all patients discontinued semaglutide treatment, but continued receiving placebo, enobosarm 3 mg, or enobosarm 6 mg as monotherapy in a double-blind fashion for 12 weeks. The Phase 2b QUALITY and Maintenance Extension clinical trial was a positive study that demonstrated that preserving lean mass and physical function with enobosarm plus semaglutide led to greater fat loss during the 16 week active weight loss period. While weight loss was similar across treatment groups in this short 16 week study, we anticipate that preservation of lean mass and function will lead to increased energy expenditure, and this effect coupled with the direct effects of enobosarm on the additional selective reduction in fat mass will result in incremental weight reduction in a longer 68 week clinical study in patients who have obesity. Forward-Looking Statements This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, express or implied statements related to the planned design, enrollment, timing, commencement, interim, topline and full data readout timing, scope and regulatory pathways for the continued development of enobosarm in patients with obesity, including the PLATEAU Phase 2b study; the design, number of sites, timing, endpoints, patient population and patient size of such trial and whether the PLATEAU trial will successfully meet any of its primary or secondary endpoints; whether the results of the Phase 2b QUALITY study and the extension maintenance study of enobosarm, including weight loss, preservation of lean mass and physical function and loss of fat mass, will be replicated to the same or any degree in the PLATEAU Phase 2b study or in any future Phase 3 studies; whether and when the PLATEAU Phase 2b study of enobosarm will produce an interim analysis and/or topline data or full data report; whether enobosarm in combination with a GLP-1 RA drug will provide a higher quality and/or greater quantity weight loss in patients; whether patients treated with enobosarm in the PLATEAU Phase 2B study will preserve lean mass and function leading to an increased use of energy and whether such effects will result in incremental weight reduction; whether patients treated with enobosarm in the PLATEAU Phase 2B study will break through the weight loss plateau and achieve clinically meaningful incremental weight reduction by preserving muscle mass and physical function; and whether enobosarm will enhance or achieve a higher quality weight loss or the preservation of muscle in, or provide important insights into quality weight loss therapy and the design of a Phase 3 clinical development program; whether the oral form of semaglutide may be used in combination with enobosarm in future Phase 3 clinical studies and whether the injectable semaglutide used in the PLATEAU Phase 2B study data of enobosarm may support the use of oral semaglutide formulation in combination with oral enobosarm in future Phase 3 clinical studies; and whether the Company will be successful in its transformation into a late stage biopharmaceutical company focused on obesity and oncology;. The words "anticipate," "believe," "could," "expect," "intend," "may," "opportunity," "plan," "predict," "potential," "estimate," "should," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based upon current plans and strategies of the Company and reflect the Company's current assessment of the risks and uncertainties related to its business and are made as of the date of this press release. The Company assumes no obligation to update any forward-looking statements contained in this press release because of new information or future events, developments, or circumstances. Such forward-looking statements are subject to known and unknown risks, uncertainties and assumptions, and if any such risks or uncertainties materialize or if any of the assumptions prove incorrect, our actual results could differ materially from those expressed or implied by such statements. Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to: the development of the Company’s product portfolio and the results of clinical studies, including any interim or topline analysis, possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; although the Company has sought and received feedback from the FDA on the designs of its clinical trials and intends to continue to do so, the FDA may ultimately disagree that the Company’s clinical trials support approval; the Company’s ability to reach agreement with FDA on study design requirements for the Company’s existing and planned clinical studies, including for the Phase 2b program for enobosarm as a weight loss or body composition drug and the number of future Phase 3 studies to be required and the cost thereof; potential delays in the timing of and results from clinical trials and studies, including as a result of an inability to enroll sufficient numbers of subjects in clinical studies or an inability to enroll subjects in accordance with planned schedules; the ability to fund planned clinical development as well as other operations of the Company; whether the Company will be able to partner with another company in the development of enobosarm or sabizabulin; the timing of any submission to the FDA or any other regulatory authority and any determinations made by the FDA or any other regulatory authority; the potential for disruptions at the FDA or other government agencies to negatively affect our business, including as a result of a future shutdown of the U.S. government; any products of the Company, if approved, possibly not being commercially successful; the ability of the Company to obtain sufficient financing, including any partnership or collaboration agreements, on acceptable terms when needed to fund development and operations and to enable us to continue as a going concern; demand for, market acceptance of, and competition against any of the Company’s products or product candidates; new or existing competitors with greater resources and capabilities and new competitive product approvals and/or introductions; changes in regulatory practices or policies or government-driven healthcare reform efforts, including pricing pressures and insurance coverage and reimbursement changes; the Company’s ability to protect and enforce its intellectual property; costs and other effects of litigation, including regulatory challenges, product liability claims, intellectual property, securities litigation and litigation with the purchaser of the Company’s FC2 business; the Company’s ability to identify, successfully negotiate and complete suitable acquisitions or other strategic initiatives; the Company’s ability to successfully integrate acquired businesses, technologies or products; and other risks detailed from time to time in the Company’s press releases, shareholder communications and Securities and Exchange Commission filings, including the Company's Form 10-K for the year ended September 30, 2025, and subsequent quarterly reports on Form 10-Q. These documents are available on the “SEC Filings” section of our website at www.verupharma.com/investors. Wegovy® is a registered trademark of Novo Nordisk A/S. Investor and Media Contact: Samuel Fisch Executive Director, Investor Relations and Corporate Communications Email: [email protected]

This article first appeared on GuruFocus. Release Date: February 11, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Veru Inc (NASDAQ:VERU) successfully completed a Phase 2B clinical trial demonstrating that Enovosarm, in combination with GLP-1 receptor agonists, can lead to selective fat loss while preserving lean mass in older patients with obesity. The FDA has provided regulatory clarity for the development of Enovosarm, offering two potential pathways for approval based on weight loss and preservation of physical function. Veru Inc (NASDAQ:VERU) completed a public offering, raising approximately $23.4 million, which strengthens its financial position. Research and development costs decreased significantly, indicating a more efficient allocation of resources. The company's cash and cash equivalents increased to $33 million, providing a solid financial foundation for future operations. Veru Inc (NASDAQ:VERU) reported a net loss of $5.3 million for the quarter, indicating ongoing financial challenges. The company is not yet profitable and continues to experience negative cash flow from operations. There is uncertainty regarding the efficacy of Enovosarm in achieving more than 5% incremental weight loss, which could impact regulatory approval. The reliance on future clinical trials for Enovosarm introduces risks related to trial outcomes and regulatory hurdles. The sale of the FC-2 female condom business has resulted in discontinued operations, which may affect future revenue streams. Warning! GuruFocus has detected 2 Warning Signs with VERU. Is VERU fairly valued? Test your thesis with our free DCF calculator. Q: Why not use the oral semaglutide in the study instead of having the optionality in phase three? Is it due to its novelty and lack of real-world data? A: Dr. Mitchell Steiner, CEO: We aim to minimize differences between the phase 2B quality study and the plateau study. The injectable form is slightly better, so we expect a better response with the oral form in phase three. The active ingredient is the same in both forms, allowing us to bridge safety data effectively. Q: Did you discuss with the FDA about using the stair climb test and specific questionnaires for functional assessment? A: Dr. Mitchell Steiner, CEO: Yes, we discussed the stair climb test with the FDA, which is sensitive to declines and anabolic intervention. The FDA suggested duplicate runs and both loaded and unloaded tests to normalize weight and challenge muscles. We also focus on patient-reported outcomes to assess clinical meaningfulness. Q: Are there any pre-specified decision rules for futility or sample size alterations in the interim analysis? A: Dr. Gary Barnett, Chief Scientific Officer: No futility analysis or sample size re-estimation is planned. The interim analysis focuses on lean mass and fat mass to confirm the direction of the study without affecting statistical power. Q: If less than 5% weight loss is observed, what degree of weight loss is needed, and how is it counterbalanced by functional benefits? A: Dr. Mitchell Steiner, CEO: If weight loss is less than 5% but similar to GLP-1 receptor agonist alone, showing a physical function benefit could still support approval. Q: What are the financial highlights for the quarter? A: Michelle Greco, CFO: Veru completed a public offering raising $23.4 million. R&D costs decreased to $1.3 million due to the wind-down of a clinical study. The net loss was $5.3 million, improved from $8.9 million in the prior year. Cash balance increased to $33 million, expected to fund operations through the interim analysis of the phase 2B study. For the complete transcript of the earnings call, please refer to the full earnings call transcript.