Veru Inc.VERUNASDAQ
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Operator: Good morning, ladies and gentlemen, and welcome to Veru Inc. Investors Conference Call. All participants will be in listen-only mode. Please note this event is being recorded. I would now like to turn the conference call over to Mr. Sam Fisch, Veru Inc. Executive Director, Investor Relations and Corporate Communications. Please go ahead. 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 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 Doctor Mitchell Steiner, Veru Inc.'s Chairman, CEO, and President. Good morning. With me on this morning's call are Doctor Gary Barnett, our Chief Scientific Officer, Michele Greco, our Chief Financial Officer and Chief Administrative Officer, Phil Greenberg, General Counsel, and Sam Fisch, Executive Director of Investor Relations and Corporate Communications. Thank you for joining our first quarter fiscal year 2026 earnings call. Veru Inc. is a late clinical-stage biopharmaceutical company focused on developing novel medicines for the treatment of cardiometabolic and inflammatory diseases. Our drug development program consists of two new chemical entities, small molecules, Novosarm and sabizabulin. The first one, Novosarm, is an oral selective androgen receptor and is being developed as a next-generation drug that, when combined with a GLP-1 receptor agonist, as demonstrated in our company's recently completed Phase 2 quality study, makes weight reduction more tissue selective, focusing on fat loss and preservation of lean mass and physical function, which is intended to lead to greater weight loss compared to GLP-1 receptor agonist treatment alone, with a focus on older patients with obesity. Our second asset, cabozantinib, a microtubule disruptor, is being developed as a broad anti-inflammatory agent to reduce vascular plaque inflammation to slow the progression of and promote the regression of atherosclerotic cardiovascular disease. This morning, we will focus on the update of our obesity program and we will also provide financial highlights for fiscal 2026 first quarter ended December 31, 2025. 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 indiscriminate significant loss of both lean mass and fat. Of the total weight loss, up to 50% is attributable to lean mass. Although the GLP-1 receptor agonist treatment has resulted in profound 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 for patients to lose fat only while preserving lean mass and physical function and bone mineral density for the highest quality weight reduction. Veru Inc. has completed a positive Phase 2b quality clinical trial conducted on 168 older patients with obesity, providing a proof of concept that Novosarm could be that next-generation drug in combination with the GLP-1 receptor agonist to make the weight loss journey more selective for only fat loss while preserving lean mass and physical function during the active weight loss period, but also notably after semaglutide was discontinued and those on monotherapy significantly prevented the regain of both body weight and fat mass such that by the end of the 28-week study, there was greater loss of fat mass while preserving lean mass for higher quality weight reduction compared to the placebo group. In September 2025, we announced a successful FDA meeting providing regulatory clarity for the development of Novosarm in combination with GLP-1 receptor agonist for greater quality weight loss in the treatment of obesity. According to FDA feedback, there are at least two possible regulatory pathways for the development of the Novosarm in combination with GLP-1 receptor agonist treatment for obesity with preservation of lean mass, which are based on incremental weight loss. First, incremental weight loss with at least a 5% placebo-corrected weight loss difference at 52 weeks of maintenance treatment with Novosarm in combination with GLP-1 receptor agonist treatment compared to GLP-1 receptor agonist treatment alone may be an acceptable primary endpoint to support efficacy for approval. Second, if the incremental weight loss is less than 5% corrected weight loss, including similar weight loss at 52 weeks maintenance treatment with Novosarm in combination with GLP-1 receptor agonist treatment compared to GLP-1 receptor agonist treatment alone, but the Novosarm treatment group demonstrates a clinically significant positive benefit such as a statistically significant and clinically meaningful benefit in the preservation of physical function, this may also be acceptable to support efficacy for approval. FDA also confirmed that Novosarm three milligrams is an acceptable dosage for future Veru Inc. clinical development. Now coincidentally, on December 19, 2025, the FDA announced that total hip bone mineral density, that's BMD, assessed by DEXA scan qualifies as a validated surrogate endpoint for drug development in postmenopausal women with osteoporosis at risk for fracture instead of the current standard that requires Phase 3 clinical studies must use bone fractures as a primary endpoint. This is relevant for our Novosarm Obesity program as it's been reported in the scientific literature that GLP-1 receptor agonist therapy affects body composition by also reducing hip BMD. In fact, the semaglutide Wegovy FDA label has recently been updated to include the safety concern of increased risk of hip and pelvic fractures based on the SELECT cardiovascular trial, which is sponsored by Novo Nordisk in over 17,000 subjects. In the SELECT trial, four to five times more hip fractures of the hip and pelvis were reported on Wegovy than in placebo in female patients and in all patients aged 75 and older. The good news for our Novosarm obesity program is that in previously published preclinical studies and rat models of postmenopausal female osteoporosis, Novosarm has been shown to have both anabolic and anti-resorptive activities that resulted in increased bone mineral density. Consequently, this means that distinct from incremental weight loss, or muscle preservation and physical function as primary endpoints, improving BMD in postmenopausal women with obesity receiving a GLP-1 receptor agonist who also have osteoporosis could be another primary endpoint going forward for Novosarm to seek regulatory approval for improving body composition. Now let's turn to the current status of our planned Phase 2b PLATO clinical study. A common and serious clinical and therapeutic challenge of GLP-1 receptor agonist treatments is that 88% of patients with obesity after one year on GLP-1 receptor agonist drug hit a weight loss plateau with a stop losing additional weight. This is based on the Cervant 1 study conducted by Eli Lilly and Company. Unfortunately, 62.6% of these patients still have clinical obesity at the time they reach the weight loss plateau. One explanation might be that the loss of muscle stimulates appetite in patients receiving a GLP-1 receptor agonist to consume more calories, which may be an important reason why patients hit that weight loss plateau. Novosarm has been shown in clinical studies to directly burn fat, preserve muscle, increase physical function, and burn more calories, which would help break through the weight loss plateau leading to incremental weight reduction. Veru Inc.'s planned Phase 2b PLATO clinical study is a double-blind placebo-controlled study to evaluate the effect of Novosarm three milligrams on total body weight, fat mass, lean mass, physical function, bone mineral density, and safety in approximately 200 older patients aged greater than or equal to 65 years of age who have obesity with a BMI of greater or equal to 35 and are initiating semaglutide treatment for 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 34 weeks to assess the percent change of baseline in lean body mass and fat mass as measured by DEXA scan. The key secondary endpoints of total fat mass, total lean mass, physical function using the Stair Climb test, bone mineral density, and a patient-recorded outcome questionnaires for physical function, HbA1c, and insulin resistance. Semaglutide was selected as a GLP-1 receptor agonist for the Phase 2b PLATO study to build on Veru Inc.'s previous clinical experience using Novosarm in combination with semaglutide in the Phase 2 quality clinical study. Further, there's now an oral form of semaglutide which may be used in combination with oral Novosarm in future Phase 3 clinical studies, making the potential bridging of the future Phase 3 clinical studies data to the Phase 2b PLATO Novosarm plus injectable semaglutide data possible. In contrast, tirzepatide injectable does not have an oral formulation. The principal investigator for the Phase 2b PLATO clinical trial will be again Steven Heimsfield, MD, Professor and the Director of the Body Composition Metabolism Laboratory at the Pennington Biomedical Research Center in Baton Rouge, Louisiana. The clinical study is expected to begin this quarter. An interim analysis to assess change in lean body mass and fat mass measured by DEXA will be conducted at 34 weeks, which is anticipated to be in 2027. I will now turn the call over to Michele Greco, CFO and CEO, to discuss the financial highlights. Michele?
Michele Greco: Thank you, Doctor Steiner. On October 31, 2025, Veru Inc. completed an underwritten public offering of 1,400,000 shares of our common stock, pre-funded warrants to purchase up to 7,000,000 shares of our common stock, accompanying Series A warrants to purchase up to 8,400,000 shares of our common stock, and accompanying Series B warrants to purchase up to 8,400,000 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 $23,400,000 after deducting underwriting costs and discounts paid by the company. In the prior year period, on December 30, 2024, Veru Inc. sold the FC2 female condom business to Clear Future Inc. In our financial statements, all direct revenues, costs, and expenses related to the FC2 Female Condom business are classified within loss from discontinued operations net of tax in the statements of operations. Now let's review the results for the three months ended December 31, 2025. Research and development costs decreased to $1,300,000 from $5,700,000 in the three months ended December 31, 2024. The decrease is primarily due to a 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. General and administrative expenses were $4,100,000 compared to $5,200,000 in the prior quarter. The decrease is primarily due to a decrease in share-based compensation. We recognized a gain on the sale of NTAPI assets of $695,000 in the prior quarter, which is based on nonrefundable consideration related to promissory notes previously due to Veru Inc. As the promissory notes are now settled, no additional gain is expected in future periods. In conjunction with the sale of the FC2 Female Condom business, we recorded a gain on extinguishment of debt of $8,600,000 in the prior year's quarter related to the termination of the residual royalty agreement. During the prior fiscal year, the company entered into a settlement agreement with On Kinetic Inc., whereby the company received a cash payment of $6,300,000 in Series D preferred stock and a warrant, which had a combined fair value of $2,500,000. The loss associated with the change in fair value of securities held related to On Kinetics was $100,000 compared with $300,000 for the prior period. The bottom line result was a net loss of $5,300,000 or $0.26 per diluted common share, compared to a net loss of $8,900,000 or $0.61 per diluted common share in the prior year's quarter. For the prior period's quarter, the net loss included a net loss of $7,100,000 from discontinued operations. Now looking at the balance sheet. As of December 31, 2025, our cash, cash equivalents, and restricted cash balance was $33,000,000 compared to $15,800,000 as of September 30, 2025. On both December 31, 2025, and September 30, 2025, there was $100,000 of restricted cash related to the sale of the FC2 female condom business. Our net working capital was $29,700,000 as of December 31, 2025, compared to $11,100,000 as of September 30, 2025. The company is not profitable and has had negative cash flow 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 through the interim analysis in the Phase 2b PLATO clinical study to assess percent change from baseline in lean body mass and fat mass as measured by DEXA scan. During the three months ended December 31, 2025, we used cash of $6,200,000 for operating activities, compared with $11,300,000 used for operating activities in the prior period. There was no cash generated from investing activities in the current period. For the three months ended December 31, 2024, we generated cash from investing activities of $17,200,000, primarily from proceeds from the sale of the FC2 female condom business of $16,200,000. Net cash provided by financing activities for the three months ended December 31, 2025, was $23,400,000, 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 in financing activities for the three months ended December 31, 2024, of $4,200,000 related to the change of control payment to SWK pursuant to the residual royalty agreement terminated in conjunction with the sale of the FC2 female condom business. Now I'd like to turn the call back to Doctor Mitchell Steiner. Doctor Steiner?
Mitchell Steiner: Thank you, Michele. With that, we'll now open the call to the question and answer session. Our first question comes from Edward Nash with Canaccord. Please go ahead. Hey, good morning, guys. Thanks so much for taking my question. I wanted to first just add just a couple of questions. One was why not use the oral semaglutide in this study as opposed to having the optionality in the Phase 3? Is it just because of its relatively new now, its lack of real-world data? I think the reason is that trying to minimize potential difference between what we saw in the Phase 2b quality study and what we want to see in the PLATO study. And so the oral form is not exactly the same as the injectable. The injectable is a little bit better. So that means that if we show what we need to show in the Phase 2b PLATO study, then we should see even better response with an oral semaglutide that doesn't do as well as the injectable. So really it's been calculated, took a step back and said, why do you want to change and add tirzepatide now? And since you created a completely different study with different outcomes potentially. We're trying to be safe as we move towards now. With that said, it's, you know, somatostatin is the active ingredient in both the injectable and the oral. And so that could be easily bridged and what you're trying to bridge is not the efficacy, because we're going to be testing the efficacy in the Phase 3, which you want to bridge is into all the safety. And you should be able to do that. Got it. Thank you. And just one follow-up is on the with regards to the function aspect, functional aspect of the FDA allowing that as a potential approval path preservation of function. Did you guys specifically discuss with the agency about stair climb test and the specific questionnaires that you're looking to employ to determine whether or not they consider those to be sufficient for that endpoint? Yeah. So we did speak to the agency specifically about stair climb. As you know, we've done five now with the quality studies, six studies previously done with Novosarm and done by our company here at Veru Inc. with 1,000 patients using StairClimb. So we have twenty years of experience with StairClimb. And it's not just talking to the agency with this trial and other trials, also every major scientific group. And stair climb still comes out as the best way to measure what's happening in this patient population. It's most sensitive to declines and it's very sensitive to anabolic intervention. With that said, the main comments that the FDA brought up was in the conduct of the study, they wanted to make sure that we did duplicate stair climb runs. In other words, the patient goes up the stairs once and goes up a second time and then you average that. And they also wanted to make sure that in addition to loaded that we did unloaded. What that means is that when a patient goes up the stairs, they unload it means they just go up just as they are. Loaded means that you add a backpack with some weight and the concept there is just kind of clever is we're trying to normalize weight. And the way you normalize weight is that you just add back the weight that they lost when they come back to that final visit. And you do that with the plates. And so this way, you're actually measuring and challenging the patient's muscle. So that's why it becomes such a sensitive measure of intervention. And so we had those kinds of discussions with the FDA. What's open is and what we're going to focus on in the PLATO study is also what happens with the patient-reported outcomes and how the patient-reported outcomes help to further define how patients function and feel. And so that's why the Phase 2 makes more sense than jumping into a Phase 3 because that will help with the clinical meaningfulness of what we're actually measuring objectively. Got it. Thank you very much. And the next question comes from Rohan Mathur with Oppenheimer. Please go ahead. This is Rohan on for Leland. Thanks for the question. I just wanted to ask on the interim analysis plans. Are there any pre-specified decision rules with respect to futility or alteration of the sample size that are part of the criteria there? Thank you. Sure. So I have Doctor Gary Barnett, our Chief Scientific Officer. And Gary? Yes. No, there is no futility analysis or sample size re-estimation associated with this interim analysis. And as you know, the primary endpoint is weight loss. And so the interim analysis is looking at lean mass and fat mass. And so the real purpose of it is to gain confirmation that we're heading in the right direction, meaning that you're seeing the lean mass preservation and the additional fat mass loss that would at 34 weeks, that should translate to 68 weeks, a weight loss benefit. And so from a statistical standpoint, by not looking at total weight loss, plus it's too early anyway, at 34 weeks, you're not taking a statistical penalty or an alpha hit at the interim, which will affect the amount of alpha spend you have at the end of the study. Got it. And just one more for me. You go down the route of assessing functional benefit and in the case that maybe less than 5% of weight loss is observed, is there any sense for what degree of weight loss needs to be seen and is that counterbalanced by the magnitude of functional benefit? Yes. So as I said in my public statements, that question has come up before. So greater than 5% alone is weight loss, incremental weight loss you're in. If it's less than 5% and the weight loss could be similar to the GLP-1 receptor agonist, meaning that you didn't see incremental weight loss difference at all. But to show the physical function benefit, then that can be a basis for approval going forward. Understood. Thank you. Ladies and gentlemen, this concludes our question and answer session. I would like to turn the conference back over to Doctor Mitchell Steiner for any closing remarks. Thank you. I appreciate everyone who joined us on today's call and we look forward to updating you all on our progress in our next investor call. Thank you again. The digital replay of the conference call will be available beginning 12 p.m. time today, February 11, by dialing +1 855-606-658 in the US and +1 (412) 317-0088 internationally. You'll be prompted to enter the replay access code which will be 7414536. Please record your name and company when joining. The conference call has now concluded. Thank you for attending today's discussion.