Veru Inc.

Good morning, ladies and gentlemen, and welcome to Veru Inc.' 's 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.' 's Executive Director, Investors 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 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, VeriRinks Chairman, CEO, and President.

Mitchell Steiner 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. Vero 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 species

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. With 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 a nose arm in our obesity program. We'll 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 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, Bureau has focused the clinical development of the Novosarm 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 stair climb tests in the Phase II quality clinical study. Vero's completed the Phase II B quality clinical trial with a multi-center, double-blind, placebo-controlled, randomized, dose-finding clinical trial designed to evaluate safety and efficacy of a Novosarm 3 mg, Novosarm 6 mg, or placebo as a treatment to augment fat loss and prevent muscle loss in 168 older patients that's greater than or equal to 60 years of age receiving semaglutide Rigovy for weight reduction. After 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, the Novosarm 3mg, the Novosarm 6mg as monotherapy in a double-blind fashion for 12 weeks. The Phase IIb quality clinical trial was a positive study that demonstrated that preserving lean mass and physical function with the Novosarm plus semaglutide led to greater fat loss. As I mentioned, Viru 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 SteriCLIMB test, which is a common activity of daily living. Declines in physical function, as measured by the SteriCLIMB test, may predict in older patients a higher risk of mobility disabilities gait difficulties, falls and bone fractures, hospitalizations, and mortality. It has been reported that serocline 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 but accelerated loss of lean mass with physical function decline. A pre-specified respondent analysis was conducted using a greater than 10% decline in sterocline power as a cutoff at 16 weeks, which is a significant loss as it represents loss of sterocline power that would naturally occur with aging over a 7- to 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-closomaglutide group had at least a 10% decline in sterocline-powered physical function at 16 weeks. And what happened to the study group that received inovosarm in combination with a GLP-1 receptor agonist? In the Phase IIb quality clinical study, inovosarm treatment preserved lean mass, which translated into a reduction in the proportion of patients The inovosome 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% sterocline power compared to the placebo plus semaglutide group, and that peak value is 0.0006. In the inovosome 6-mg group plus semaglutide, There was a 44.1% relative reduction in the proportion of patients with at least a 10% decline in serocline 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 IIb 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 a novus arm 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 IIb 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 Surmont 1 study conducted by... 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, no results have 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 a nose on 3 milligrams on total body weight, fat mass, lean mass, and physical function, bone mineral density, and safety, and approximately 200 older patients, age greater than or equal to 65, who have obesity, BMI greater than 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 percent change from baseline and total body weight at 68 weeks. The interim analysis will be conducted at 36 weeks to assess the percent change from baseline and 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 the steroid climate 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 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 the noxon to break through the weight loss plateau observed in patients receiving 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 II B plateau study to build on Viru's previous clinical experience using a noxon in combination with semaglutide in the positive Phase II quality clinical study. Further, the clinical data from the Phase II B plateau clinical study using injectable semaglutide may support the use of oral semaglutide and oral Anobisarm fixed-dose combination in future Phase III clinical studies. In contrast, there are no approved oral formulations, which is epitite. On March 9, 2026, we announced the enrollment of the first patient 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-inch of analysis, which is expected in Q1 calendar year 2027. Now, VIRU 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 2.5 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 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 Novosarmin in combination with 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?

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 Inovacerm 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 Intapi 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 VIRU. 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 on-kinetics 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 13 cents per diluted common share, compared to a net loss of $7.9 million, or 54 cents 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 ClearFuture in the settlement of a dispute related to a pre-closing tax receivable and liability, which is included as income from discontinued operations. In the prior year period, viewers sold the FC2 female condom business to ClearFuture. In our financial statements, all direct revenues, costs, and expenses related to the FC2 female condom business are classified within loss from discontinued operations net of tax in the statement of operations. Net loss was $2.7 million or 12 cents 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 IIb quality clinical study for 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 a gain on the sale of the entire fee 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 39 cents per diluted common share compared to a net loss of $9.6 million or 66 cents per diluted common share in the prior period. The net loss was $8.1 million or 38 cents 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 2B 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 six 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 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 Entafi 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 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 now would like to turn the call back to Dr. Steiner. Dr. Steiner?

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

Ladies and gentlemen, at this time, we will begin the question and answer session. To ask a question, you may press star, then 1 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 2. 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 1 to rejoin the question queue. We will pause momentarily to assemble our roster. The first question today comes from Leland Gershaw with Oppenheimer. Please go ahead.

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 supportives? And also wanted to ask, in further studies, with another zone. Given the development of evolving agents for obesity, you know, some orals are coming through. Others want to know if the design would factor those agents as well. Would the ultimate label be agnostic to the primary weight loss agent? Would you need to study So, thank you, Leland.

So, the first question is basically, if we're successful, you know, 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. 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 at least you're moving forward with incrementally lost. 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 that 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. And 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. And so that can be very interesting. As 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.

It's a perfect trial because it's measuring all these things in body composition that can inform us on whether they face

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. And 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 II 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 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, the 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, you know, 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, it certainly initially is 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 you probably 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-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?

Yeah, it's a great question. I think that at some point, I can envision, remember, the consequence that we're treating with an ovus arm is weight loss. And weight loss occurs with all of the glyphs 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 studies. I think that I can see a world where we include multiple different incretins 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 three programs.

Thank you.

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, and I look forward to updating all of you on our progress on our next investors call. Have a great day.

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