Good morning, ladies and gentlemen, and welcome to Veru, Inc.'s Investors Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After this morning's discussion, there will be an opportunity to ask questions. Please note this event is being recorded. I would now like to turn the conference call over to Mr. Sam Fish. Various Inc.'s 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 in 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 that 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, Barry Wings Chairman, CEO, and President. Good morning. With me on this morning's call are Dr. Gary Barnett, our Chief Scientific Officer, Michelle Greco, our Chief Financial Officer and Chief Administrative Officer, Phil Greenberg, General Counsel, and Sam Fish, Executive Director of Investor Relations and Corporate Communications. Thank you for joining our first quarter fiscal year 2026 earnings call. Vera 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 Cibizabulin. The first one, Novosarm, is an oral selective antireceptor modulator, SARM, and is being developed as a next-generation drug that when combined with a GLP-1 receptor agonist, and as demonstrated in our company's recently completed Phase II quality study, makes weight reduction more tissue-selective of 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. A second asset, serbizibulin, 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 our obesity program, and we will also provide financial highlights. The 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 non-selective 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 the 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. Viro's completed positive phase 2B quality clinical trial conducted in 168 older patients with obesity provided the proof of concept that a nose arm could be that next generation drug in combination with a 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 semaglotype 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 of 2025, we announced a successful FDA meeting providing regulatory clarity for the development of the Novus Arm in combination with GLP-1 receptor agonists 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 Novus Arm in combination with GLP-1 receptor agonists 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 a nervous arm 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 of maintenance treatment with Inovus Arm in combination with GLP-1 receptor agonist treatment compared to GLP-1 receptor agonist treatment alone. But the Inovus Arm 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. The FDA also confirmed that an opus arm 3 milligrams is an accessible dosage for future viral 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 Instead of the current standard, it requires Phase III clinical studies must use bone fractures as a primary endpoint. This is relevant for our Inovus Arm 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 semiaclutide-Wagobi FDA label has recently been updated to include the safety concerned increased risk of hip and pelvic fractures based on the SELECT cardiovascular trial, which was sponsored by Novo Nordis and over 17,000 subjects. In the SELECT trial, four to five times more hip fractures of the hip and pelvis were reported on Wigobi than in placebo in female patients and in all patients aged 75 and older. The good news for our Novosom obesity program is that in previously published preclinical studies and rat models of postmenopausal female osteoporosis, and Novus Arm has been shown to have both anabolic and anti-resorptive activities that result 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 can be another primary end point going forward for a no-osome-to-seek regulatory approval for improving body composition. Now, let's turn to the current status of our planned phase 2b plateau clinical study. A common and serious clinical and therapeutic challenge for GLP-1 receptor agonist treatments is that 88% of patients with obesity after one year on a GLP-1 receptor agonist drug hit a weight loss plateau where they stopped losing additional weight. This is based on the CERMONS-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 may stimulate 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. Inovosarm has been shown in clinical studies to directly burn fat to preserve muscle to increase physical function and to burn more calories, which would help break through the weight loss plateau, leading to incremental weight reduction. Vero's plan phase 2B plateau clinical study is a double-blind, placebo-controlled study to evaluate the effect of Inovosarm 3 mg 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 years of age who have obesity with a BMI of greater or equal of 35 and are initiating semacritide treatment for weight reduction. The primary efficacy endpoint of this study is the percent change from baseline and 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 are total fat mass, total lean mass, physical function using a stair climb test, bone mineral density, and a patient-reported outcome in questionnaires for physical function, HbA1c, and insulin resistance. Simaglitide was selected as a GLP-1 receptor agonist for the Phase 2B Plateau study to build on Viru's previous clinical experience using Anobosarm in combination with Simaglitide in the Phase 2B quality clinical study. Further, there's now an oral form of Simaglitide, which may be used in combination with oral Anobosarm in future Phase 3 clinical studies, making the potential bridging of the future Phase III clinical studies data to the Phase IIb Plateau and Novosarm plus injectable semaglutide data possible. In contrast, terzepatide injectable does not have an oral formulation. The principal investigator for the Phase IIb Plateau clinical trial will be, again, Stephen Himesfield, 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, and interim analysis to assess change in lean body mass and fat mass, as measured by DEXA, will be conducted in 34 weeks, which is anticipated to be in the first quarter of calendar year 2027. I will now turn the call over to Michelle Greco, CFO, CAO, to discuss the financial highlights.

Thank you, Dr. Steiner. On October 31, 2025, Vero 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 three dollars 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 dollars after deducting underwriting costs and discounts paid by the company in the prior year period on december 30th 2024 beer 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 discontinuing 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 $1.3 million from $5.7 million dollars in the three months ended December 31st, 2024. The decrease is primarily due to a wind down of the phase 2b quality clinical study for a Novus arm as a treatment to augment fat loss and prevent muscle loss, which was completed during fiscal 2025. General administrative expenses were 4.1 million dollars compared to 5.2 million dollars in the prior quarter. The decrease is primarily due to a decrease in share-based compensation. We recognize a gain on the sale of entity assets of $695,000 in the prior 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. In conjunction with the sale of the FC2 female condom business we recorded a gain on extinguishment of debt of 8.6 million dollars 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 kinetics inc whereby the company received a cash payment of 6.3 million dollars and series d preferred stock and a warrant, which had a combined fair value of $2.5 million. The loss associated with the change in fair value of securities held related to iKinetics was $0.1 million compared with $0.3 million for the prior period. The bottom line result was a net loss of $5.3 million or $0.26 per diluted common share compared to a net loss of $8.9 million 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 $7.1 million from discontinued operations. Now looking at the balance sheet. As of December 31, 2025, our cash, cash equivalents, and restricted cash balance was $33 million compared to $15.8 million as of September 30, 2025. On both December 31, 2025 and September 30, 2025, there was .1 million dollars of restricted cash related to the sale of the FC2 female condom business. Our net working capital was $29.7 million as of December 31, 2025, compared to 11.1 million dollars as of September 30th, 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 plateau clinical study to assess percent change from baseline and lean body mass and fat mass as measured by DEXA scans. During the three months ended December 31, 2025, we used cash of $6.2 million for operating activities compared with $11.3 million 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 $17.2 million, primarily from proceeds from the sale of the FC2 female condom business of $16.2 million. Net cash provided by financing activities for the three months ended December 31st, 2025, 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 three months ended December 31st, 2024 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?

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

Ladies and gentlemen, at this time we will begin the question and answer session. To ask a question, you may press star, then one on your telephone keypad. If you are using a speakerphone, we ask that you pick up your handset before pressing the keys to ensure the best sound quality. To withdraw your question, please press star and then two. Please limit yourself to one question and one follow-up. If you have further questions, you may re-enter the question queue. Once again, that is star one to rejoin the question queue. Our first question comes from Edward Nash with Kianakord. 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 somatolatide in this study as opposed to having the optionality in the phase three? Is it just because it's relatively new now, it's lack of real-world data?

I think the reason is that we're trying to minimize the potential difference between what we saw in the Phase 2B quality study and what we want to see in the Plateau study. And so, you know, the oral form is not exactly the same as the injectable. The injectable is a little bit better. So that means that, you know, we show what we need to show in the Phase 2B plateau study. Then we should see even a 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 to this hepatite now, in a sense you create a completely different study with different outcomes potentially? So we're trying to be safe as we move towards it. Now, with that said, it's, you know, somaticase 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 three. What you want to bridge is into all the safety, and you should be able to do that.

Got it. And just one follow-up is on the, with regards to the function aspect, In fact, functional aspect of the FDA allowing that as a potential approval pathway, preservation of function. Did you guys specifically discuss with the agency about stair climb tests and the specific questionnaires that you're looking to employ to determine whether or not they consider those to be sufficient for that endpoint?

So, yes, 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 the Novus Arm and done by our company here at Viru, with 1,000 patients using stair climb. So we have 20 years' experience with stair climb, and it's not just talking to the agency with this trial and other trials, but 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 comment that the FDA brought up was in the conduct of the study, they wanted to make sure that we did duplicate stair climb runs. So in other words, the patient goes up the stairs once, and then goes up a second, 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, unloaded means they just go up just as they are. Loaded means that you add a backpack with some weight. And the concept there, which is kind of clever, is that 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 for that final visit. And you do that with the plates. And so this way you're actually measuring and challenging the patient's muscles, and 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 helps to further define how a patient functions and feels. And so that's why the phase two makes more sense than jumping to a phase three, 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 Mather with Oppenheimer. Please go ahead.

Hey, this is Rohanan 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 alterations of the sample size that are part of the criteria there? Thank you.

So, I have Dr. Gary Barnett, our chief scientific officer. Gary?

Yeah, no, there's 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 instrument 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 at 34 weeks that should translate to 68 weeks of 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. If 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?

Yeah, so as I said in my public statements, that question has come up before. So greater than 5% alone, 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 alone, meaning that you didn't see an 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 Dr. Mitchell Steiner for any closing remarks.

Thank you. I appreciate everyone who joined us on today's call. I look forward to updating you all on our progress in our next investor call. Thank you again.

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