Veru Inc. (VERU) Q3 2024 Earnings Report, Transcript and Summary

Good morning, ladies and gentlemen, and welcome to Veru Inc.'s Investors Conference Call. [Operator Instructions] Please note, this event is being recorded. I would now like to turn the conference over to Mr. Sam Fisch, Berrinks, 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 Dr. Mitchell Steiner, Veru Inc's Chairman, CEO and President.

Good morning. With me on this morning's call are Dr. Gary Barnette, Chief Scientific Officer; Michele Greco, Chief Financial Officer and Chief Administrative Officer; Michael Purvis, the General Counsel and Executive Vice President of Corporate Strategy; and Sam Fisch, Executive Director of Investor Relations and Corporate Communications. Thank you for joining our Q3 fiscal year 2024 earnings call. Veru is a late clinical stage biopharmaceutical company focused on developing innovative medicines for high-quality wave loss, oncology and acute respiratory distress syndrome. The company's drug development pipeline includes 2 late-stage novel oral small molecules in enobosarm and sepisabululin. In our weight loss pipeline, we have Enobosarm, also known as Austria-MK-2866 GTX-024 and VR-024, which is an oral selective angio-receptor modulator, SARM for short. Enobosarm being developed as a treatment in combination with a weight loss drug like glucagon-like peptide-1 receptor agonist, also known as a GLP-1 receptor agonist to augment that loss and to avoid muscle locks and overweight or obese patients for chronic weight management. In our oncology pipeline and pending additional external funding or pharmaceutical partnership, we have a Enobosarm combination with abemaciclib as a second line treatment of angel receptor positive, estrogen receptor positive and human epidermal growth factor II negative metastatic breast cancer in our infectious and inflammatory disease pipeline and similarly pending additional external funding of pharmaceutical partnership, we have sabizabulin, a microtubule disruptor, which is a planned Phase III clinical trial for the treatment of hospitalized patients with viral-induced ARDS. The company also has an FDA-approved commercial product, the FC2 female condom internal condom for dual protection against unplanned pregnancy and sexually transmitted infections. This morning, we'll provide an update on the current focus of our company, which is the development of Enobosarm, an oral SARM in combination with Wegovy , which is semaglutide, a GLP-1 receptor agonist to preserve muscle glass and to augment fat loss for a potentially higher quality weight loss. We'll also provide financial highlights for our third quarter fiscal year 2024. Lipid receptor agonist, which included Ozempic, , Sefone and Mounjaro, were very effective drugs that cause significant weight loss. Unfortunately, up to 50% of the total weight loss comes from muscle, which is problematic as muscle is necessary not only for strength and physical function, but also muscle with a metabolic tissue that may play a role in allowing a higher-quality wave-loss. To clarify this point, nose preservation may assist in high-quality weight loss in 3 ways. First, we need a drug that given in combination with GLP-1 receptor agonist will prevent the loss of muscle caused by GLP1 receptor agonist to preserve physical function in older adults who had risk for muscle loss and who overweight and obese. According to the CDC, 42% of older adults have obesity in the United States and could benefit from Waveband medication. Up to 34% of obese patients over the age of 60 have sarcopenic obesity. Sarcopenia being age late loss of muscle. This large subpopulation of sarcopenic-obese patients is especially at risk when taking a Glucagon receptor drug for weight loss as they may already have critically low amounts of muscle due to age-related muscle loss. Because of the magnitude and speed of muscle loss, while on glucagon-receptor agonist therapy for weight loss, glucagon receptor agonist drugs may accelerate the development of frailty and muscle weakness in Obese overweight elderly patients. Muscle weakness may lead to poor balance, decreased gate speed, mobility, disability, loss of independence and high-risk for falls and fractures. In fact, the safety section of the package insert for wegovy has been updated based on the recently reported select cardiovascular outcome clinical trial, which now highlights a 400% increase in pelvic and hip fractures that were observed in patients greater than the age of 75 years receiving VEGOVI compared to placebo patients, and that was 2.4% versus 0.6%. Practice of the hip and pelvis typically occur because of falls, which increased would decrease muscle mass. Second, for all patients who are overweight or obese, muscle preservation may prevent the GLP-1 receptor agonist weight loss plateau. Significant depletion of muscle mass may be one of the may also be one of the reasons where patients with GLP-1 receptor agonist drugs retailors plateau, meaning the rate of well slows or stops while taking the GLP-1 receptor agonist drug. The hypothesis is that loss of muscle creates a muscle deficit that causes low energy balance and triggers in the brain to signal to increase appetite that counters the inhibition of appetite. GLP-1 receptor agonist drugs thus leading to the weight loss plateau. Without a muscle deficit clip-on drugs may maintain the loss of appetite and reduction of calorie consumption, which may potentially be moved more fat mass with greater weight loss. Third, for all patients who overweight obese, muscle depletion may trigger the overeating that occurs when the patient discontinues glucagon receptor agonist, resulting in a rebound weight gain that is that we gained their original weight. But now the regained way is composed almost all of that. Having a drug that maintains adequate muscle reserve when the Glucagon receptor drug is discontinued and prevent this rebound weight gain and help with the maintenance of weight loss. We believe that a Enobosarm, or novel oral selective and receptor modulator may be the best drug candidate to address this urgent unmet medical need to preserve muscle in patients receiving a glucagon receptor agonist for weight loss. Data from our clinical trials and preclinical support studies Enobosarm's potential. Enobosarm is given as a once a day oral dose and Enobosarm works through the androgen receptor in a well-established mechanism. Enobosarm demonstrates tissue selectivity as it improves and preserves lean body mass, muscle mass and physical function. In addition, Enobosarm also directly causes a breakdown of fat and prevents storage of fat, resulting in a decrease in fat mass. This represents a different nonoverlapping mechanism of drug action to reduce fab that's distinct from a GLP-1 receptor agonist, which suppress suppresses appetite, resulting in a low caloric state. Therefore, if Enobosarm is given with the GLP-1 receptor agonist, the combination utilizes 2 different mechanisms to increase the loss of fat. Also Enobosarm builds and heals bone, providing another potential benefit to treat bone loss, which is also known as osteoporosis to prevent fractures. The Enobosarm has been previously studied in 5 clinical studies that measure muscle as an endpoint, involving 960 day older men and post-menopausal women as well as older patients who have muscle wasting because of advanced cancer. An advanced cancer population is relevant as advanced cancer causes a loss of appetite, resulting in significant unintentional loss or wasting of both muscle and fat mass similar to what's observed with the GLP-1 receptor agonist treatment. The totality of the clinical data from these 5 clinical trials demonstrate that Enobosarm treatment leads to increases in muscle glass with improvement in physical function as well as significant reduction in fat mass. The expectation is that Enobosarm in combination with glucagon receptor agonist with both preserved muscle and augment fat reduction, resulting in a higher quality total weight loss. Furthermore, Enobosarm has a large safety database, which includes 27 clinical trials solving 1,581 men and women dosed with Enobosarm with some patients dosed for over 2 years. In this large safety database, Enobosarm is generally well tolerated without masculinizing effects in women. Reversible mild liver enzyme elevations have been reported, which are mostly Grade 1 adverse events, there were no grade 3 or grade 4 adverse events. To be clear, no drug-induced liver injury has been observed for any of the 27 clinical studies evaluating Enobosarm. Furthermore, there were no increases in gastrointestinal side effects compared to placebo. This is important as there is already significant and frequent gastrointestinal side effects with a GLP-1 receptor agonist treatment alone. Now turning to our Enobosarm clinical program for high-quality weight loss. We're conducting the Phase IIb quality clinical trials of Qualtiname the trial, which is a multicenter, double-blind, placebo-controlled, randomized dose-finding study to evaluate the safety and efficacy of Enobosarm 3 milligrams Enobosarm 6 milligrams compared to placebo in combination with the wegovy with is semaglutide cliff receptor agonist and approximately 150 older patients greater than the age of 60 who are overweight or obese. Purpose of the Phase IIb clinical trial is to select the optimal dose of Enobosarm in combination with equipment receptor agonist that best preserves muscle and augments a reduction in fat mass for a better body composition at 16 weeks of treatment. The primary endpoint of the Phase IIb clinical trial will be the change in total lean body mass from baseline to 16 weeks and key secondary endpoints will be the change in baseline to 16 weeks in total fat mass, total body weight and physical function as measured by the serocime test. After completing the 16-week efficacy dose-finding portion of the Phase IIb clinical trial, participants will then continue into a blinded Phase IIb extension clinical trial, while all patients will stop receiving equip receptor agonist, but we'll continue taking placebo, Enobosarm 3 milligrams or Enobosarm 6 milligrams for an additional 12 weeks. The blinded Phase IIb extension clinical trial will evaluate the maintenance of weight loss, meaning whether Enobosarm can maintain muscle and prevent the fats and weight gain that occurs after discontinuing the lion receptor agonist. We believe that assessing the effects of Enobosarm in lean body mass and fat master 16 weeks' time point should be adequate to demonstrate significant loss of muscle in the semaglutide and placebo cohort. Support comes from the STEP-1 study reported by Wilding at all in the New England Journal of Medicine. The step 1 study that evaluated semaglutide for weight loss and overweight and obese patients showed that 49% of the total weight loss that's lost in that 68-week study occurred by week 16. Approximately 40% of the total weight loss was attributed to muscle loss. As Novosarm a muscle drug that also burns fat, our current Phase IIb clinical program is designed to provide body composition clinical data to support the Phase III clinical development of novosarm for precision high-quality weight loss by answering the following clinical questions related to muscle. For risk older adults who are overweight or obese, can novosarm prevent loss of muscle to preserve physical function. For all patients who are overweight obese can a novosarm or preserve muscle to prevent the Glucagon receptor agonist, weight loss plateau. And for all patients who overweight obese can novosarm maintain adequate muscle reserve when GLP-1 receptor agonists are discontinued to prevent the rebound weight gain, which is almost all fat. I'm proud of our team as they have expeditiously executed the novosarm Phase IIb quality clinical program. We prioritized the company's clinical development activities to address this new important unmet need in November of 2023. We filed the IND with the FDA in January of 2024. We received FDA clearance on the IND in February of 2024. We made a strategic decision to upsize the size of the trial to 150 patients to increase the power of the study. We initiated this Phase IIb quality study in April of 2024. Clinical studies being conducted in 14 clinical sites in the United States. This morning, I'm pleased to report that we have completed the greater than 150 patient enrollment for the Phase IIb quality study. can now anticipate that the last patient to complete the Phase IIb quality study will be in December of 2024 with top line clinical results of the Phase IIb clinical study expected in January of 2025. Furthermore, the top line results of the separate blinded Phase IIb extension clinical study may now be expected in the second calendar quarter of 2025. We believe we have sufficient financial resources on hand with cash of $29.2 million at the end of June 2024 to complete and provide results on both the Phase IIb quality clinical trial and the Phase IIb extension clinical trial. I will now turn the call over to Michele Greco, CFO, COO, to discuss the financial highlights. Michele?

Thank you, Dr. Steiner. Let's start our highlights with the third quarter results for the 3 months ended June 30, 2024. Overall, net revenues were $4 million compared to $3.3 million in the prior year's third quarter. The company's quarterly sales for its U.S. prescription business were $552,000 compared to $863,000 in the prior year's third quarter. Net revenue from the Global Public Sector business for the quarter was $3.4 million compared to $2.5 million in the prior year's quarter. The increase in the public sector business is for increased shipments under our contracts with UNFPA and USAID. Overall, gross profit was $1.3 million or 34% of net revenues compared to $1.2 million or 37% of net revenues in the prior year quarter. Gross profit increased due to an increase in units sold. The decrease in gross margin is due to the change in sales mix with the U.S. prescription business, which has a higher profit margin, comprising a smaller percentage of total net revenues. Operating expenses for the quarter decreased to $12.4 million compared to the prior year's quarter of $19.7 million. The decrease is primarily due to research and development costs, which decreased to $4.9 million compared to $8.8 million in the prior year quarter and the decrease in selling, general and administrative expenses of $3.4 million from $10.9 million in the prior year quarter to $7.5 million in the current quarter. The decrease in research and development costs is due to our drug development strategy to focus development efforts on those drug candidates with the best opportunity for long-term success and shareholder value creation while matching available funding. During the quarter, we initiated the Phase IIb quality clinical study. The decrease in selling, general and administrative expenses is primarily due to significant costs incurred in the prior year related to preparation for the potential commercialization of sabizabulin for COVID-19 prior to the FDA's declination of the company's EUA application and an increase in personnel costs in the prior year due to increased headcount for the potential commercialization. These additional costs and incremental headcount have now been reduced post the EUA declination. On April 19, 2023, we sold our entified product to an kinetics for $20 million. We received $6 million at closing and promissory notes of $14 million, which are recognized as additional gain on the sale when nonrefundable consideration is received. During the current quarter, we recognized an additional gain on sale of $110,000 compared to the gain on sale of $4.7 million in the prior period. The operating loss for the quarter was $10.9 million compared to $13.7 million in the prior quarter. Nonoperating income was $132,000 compared to $1.3 million in the prior year's quarter. The reduction is primarily due to the change in the fair value of the derivative liabilities related to the FC2 synthetic royalty financing. For the quarter, we recorded a tax expense of $162,000 compared to $58,000 in the prior year's quarter. The bottom line results for the third quarter was a net loss of $11 million or $0.07 per diluted common share compared to a net loss of $12.5 million or $0.14 per diluted common share in the prior year's quarter. During the third quarter, we used cash of $5.6 million for operating activities. Now turning to the results for the 9 months ended June 30, 2024. For the first 9 months of fiscal 2024, total net revenues were $10.2 million compared to $12.4 million in the prior year period. Net revenues from the U.S. prescription business were $1.8 million compared to $5.2 million in the prior year period. Included in the net revenues for the prior period were $3.9 million for sales to the Pico. The reduction of prescription business net revenues is due to not having any revenues from the Pill Club in the current period due to the fact the Pill Club's Chapter 11 bankruptcy filing in the prior year. Net revenues from the Global Public Sector business for the period were $8.4 million compared to $7.2 million in the prior year's period. Overall, gross profit was $3.2 million or 31% of net revenues compared to $6 million or 48% of net revenues in the prior year period. The decrease in gross profit and gross margin is due to the change in the sales mix with the U.S. prescription business, which has a higher profit margin, comprising a smaller percentage of total net revenues and an increase in our cost of sales due to a charge of $1.2 million for an obsolete stock reserve related to inventory in the U.S. prescription channel. Operating expenses decreased by $63.4 million to $32.9 million compared to the prior year of $96.4 million. The decrease is driven by a reduction in research and development costs of $37.7 million to $9.5 million from $47.3 million in the prior year and a reduction in selling, general and administrative expenses of $17.9 million from $41.3 million in the prior year to $23.4 million. The factors contributing to the decrease in research and development costs and selling, general and administrative expenses are the same as those described for the quarter. During the prior year, we also recorded an impairment charge of $3.9 million related to in-process research and development costs and a provision for credit losses of $3.9 million related to the receivables from the Pico. During the 9 months, we recorded a gain on the sale of entity of $1 million compared to $4.7 million in the prior year period. Operating loss for the period was $28.7 million compared to $85.6 million in the prior year, a decrease of $56.9 million, which is primarily due to the reduction in operating expenses. Nonoperating expenses were $289,000 compared to operating income of $508,000. For the 9 months, we recorded a tax expense of $272,000 compared to a tax benefit of $77,000 in the prior year. The bottom line results for the first 9 months of fiscal 2024 was a net loss of $29.3 million or $0.22 per diluted common share compared to a net loss of $85 million or $0.012 per diluted common share in the prior year. The net loss for the company decreased by $55.7 million for the 9-month period. The main reason for the decrease in the net loss relates to the company's focus on drug candidates with the best opportunity for long-term success and shareholder value creation while matching available funding and elimination of the commercial team and related commercialization expenses for the potential launch of sabizabulin for COVID-19. Now looking at the balance sheet. As of June 30, 2024, our cash balance was $29.2 million and accounts receivable were $1.6 million compared to a cash balance of $9.6 million and accounts receivable balance of $4.5 million as of September 30, 2023. Our net working capital was $27.9 million on June 30, 2024, compared to $5.1 million on September 30, 2023. During the 9 months ended June 30, 2024, we used cash of $17.3 million for operating activities compared with $78.5 million used for operating activities in the prior period. We generated cash from financing activities for the 9 months ended June 30, 2024, of $36.8 million compared to $9 million in the prior period. On December 18, 2023, we completed an underwritten public offering of our common stock, which included the exercise in full of the underwriter's option to purchase additional shares. Net proceeds to the company from this offering were approximately $35.2 million after deducting underwriting discounts and commissions and costs incurred by the company. All the shares sold were offered by the company. We are working to increase the future FC2 net revenues in the U.S. prescription channel by growing awareness and driving demand of FC2 through increased marketing efforts for our own telehealth platform. We're starting to see increases in our global public sector business from efforts to increase FC2 market awareness in developing countries. Now I'd like to turn the call back to Dr. Steiner. Dr. Steiner.

Thank you, Michele. All of the GLP-1 receptor agonist was mainly by creating a low caloric starvation state by reducing appetite that results in the nonselective loss in both muscle and fat tissues to cause weight loss. Using a muscle preserving drug that can also decrease fat mass like enobosarm in combination with the glucagon receptor agonists may allow for the enhanced reduction of fat mass higher-quality precision weight loss in not only older patients who are overweight or obese, but also for all patients who overweight Orbis. This is truly an unmet medical need. We believe that enobosarm the best investigational drug candidate to address the muscle loss caused by glucagon receptor agonist drugs. Enobosarm the first in class arm has a once a day oral dosing has demonstrated tissue selectivity, utilizes a well-known mechanism of action to antigen receptor to favorably change by the composition. Activation of the ante receptor increases muscle mass, improves physical function and decreases fat mass to potentially achieve a higher quality of weight loss. enobosarm has a favorable safety profile and would not add to the gastrointestinal side effects that are already observed with a glucagon-receptor agonist treatment alone. The global obesity and overweight drug market is projected by many research analysts to be $100 billion annually by 2030. The combination of enobosarm with glucagon receptor agonist potentially represents a multibillion-dollar opportunity. I should note that we also have new clinical data that we generated from reexamination of the clinical data from some of the previous 5 clinical muscle studies evaluating enobosarm that further support the potential of enobosarm for the preservation of total lean body mass and the reduction of fat mass to improve body composition for higher-quality weight loss in patients who obese overweight. The company will be presenting an abstract of the obesity week 2024, and that's in November 2 through 6 in San Antonio, Texas. Furthermore, we've been invited to present keynote lectures at the fourth edition of the World Obesity and Wake Management Congress being held October 24 to 26 in Baltimore, Maryland, in the 17th International Conference of the Society of sarcopenia, cachexia-wasting disorders being held December 6, 8 in Washington, D.C. I've also been invited to co-chair a session entitled body composition changes induced by glycine receptor agonist and obesity therapy at the International Conference of the society and sarcopenia cachexia and wasting disorders. We are very excited about the prospects of enobosarm to address this new and important unmet medical need, and we are looking forward to the top line results of this important and timely Phase IIb quality clinical study. With that, I'll now open the call to questions. Operator?

[Operator Instructions] And the first question comes from Yi Chen with H.C. Wainwright.

Assuming positive results coming out of the Phase IIb quality study, how soon can you advance the candidate to the next step and whether you plan to find a partnership for a potential registration study.

Thank you,. So assuming we have a positive study, which means that now that we have complete enrollment, we can now have a little bit more certainty, have a lot more certainty in terms of how the trial will progress in terms of information. So the expectation is the last patient will complete the study, the 16-week portion of the study in December give us some time here to clean up the data and look at the data and get the top line results, call it, January. So in January of 2025, we will have the Phase IIb quality clinical trial data. The reason I say that way is the extension trial is not required for us to move forward with talking to the FDA on potentially talking to partners. So really, it's the data that we get in January that will start to borrow rolling from a standpoint of moving forward. So moving forward, means collect the information, go back to the FDA and start having further discussions now with real data in hand. I mean this data really represents the first muscle drug, and we have competition with, for example, myostatin inhibitors, but this data will be the first muscle drug to be given in combination of GLP1 to see what the results look like. I mean all these other drugs pretty much have no clinical data in combination with GLP1 and the data that they use to move forward to the Phase IIs just like us is data showing muscle preservation reduction in fat and other conditions, not in combination with GLP1 so with that said, we have a real opportunity to meet with the FDA and understand what the Phase III clinical program will look like. With that said, also, this is also an ideal time with data on hand to begin to have discussions for potential partnerships. As I mentioned in previous calls, we have talked to the major players. As you would expect, the expectation is for us to get this study done so we'll have real data, so we can have real discussions. And so that's the way to think of it is after January, it gives the company an opportunity to begin moving on the regulatory front and moving on the partnership front.

And the next question comes from Leland Gershell with Oppenheimer. Mitch.

Just a question actually on safety. In the trials that you referenced in the 5 studies that you referenced with the enobosarm, I think the high dose was 3 milligrams. I know you're testing up to 6 in the current quality study. Just wanted to ask kind of what gives you confidence that you'll be okay to expect to liver at 6? And are there any considerations with respect to the types of patients in the study, i.e., overlay obese, therefore, may have bad accumulation in the liver could that put them in for the risk of having tiering? And also, is there any provision for our alcohol cessation during the study, which also could be affected.

So the answer to the first, I'm going to answer a couple of those questions and then I'm going to ask Dr. Gary Barnette, our Chief Scientific Officer, to answer some of those questions. So as it relates to the database, you're absolutely right, the database that we have for muscle as an end point goes up to 3 milligrams. Of course, we have a single ascending dose and multiple ascending dose studies that were done at much higher doses as high as 100 milligrams. But I need to remind everybody that we also have done almost 250 patients at 9 milligrams or 18 milligrams in our breast cancer program. And some patients have been taking those doses for as high as long as 2-year loss. So we do have data for safety above the 6 milligram and again, with no evidence of liver toxicity defined as drug-induced liver injury. As it relates to triglycerides, one of the things that we did see in a different patient population, the older patients, men over the age of 60 and women postmenopausal is we did see about a 30% reduction in triglyceride. So one of the mechanisms for if you worry about overweight patients or these patients that may have fatty liver, we may be able to reduce the triglycelides, which is the source of the fatty liver. As it relates to alcohol, I'm going to have to ask Dr. Gary Barnette what we're doing in a clinical protocol.

Yes. We are not excluding alcohol. We do monitor the alcohol history in the alcohol intake as we go forward. Of course, we're excluding patients with alcohol-associated cirrhosis, alcohol associated hepatitis, alcohol-associated sodaliver. If we know those things, they're excluded from the study. But we don't exclude the intake of alcohol during the study, but we do monitor that.

And the next question comes from Gary Nachman with Raymond James.

Pages on for Gary. Congrats on the quarter. So my first question is, can you just talk about how you're expecting the Phase IIb to progress now that you're fully enrolled? And if we should expect any incremental updates before you report top line in January? And on that safety question, are you pleased with everything you're seeing with the safety committee thus far in that current trial? And then I also have a follow-up.

Yes. So as it relates to the Phase 2 and what to expect. So as I promised, we would announce when we fully enrolled the study. And so that's probably the last announcement in terms of progress because the last patient out will be December. And so the next report will be the actual top line data. As it relates to safety, we're pleased with what we're seeing so far. But we enrolled 150 patients in 3 months. And so many of these patients are still just starting their part of their first month. So it's still early times. But again, the 3-milligram dose we've used in 5 clinical trials and other trials, and we've used 9 milligrams and 18 milligram. So we're not expecting anything strange, but that's why we run the study, and that's where we're going to follow. And so it's hard to say much more about safety at this point, except there's no surprises. And then as it relates to I think we're going to ask you another question after that, you said.

Yes. I just wanted to ask a little bit more about some of the secondary endpoints in the Phase IIb? And then how do you take them to trend? And specifically on the home IR. Can you talk a bit more about the significance of that and what you're hoping to show?

Yes. So home IR, we have mistakenly put on our slide that we will be measuring home IR in this patient population. We have measured homeware in previous patient populations and show the benefit of insulin resistance. For this Phase II, given how short it is, we've decided to move the home IR into the next study to the Phase III study. So that won't be one of the data points that you'll see. You will see, again, the body mass, fat mass, which will be the body composition endpoints. We'll have total weight, body weight, so we'll see that. And then from a functional endpoint, we'll be measuring physical function by Steroclime. The reason that's important is to sterling power Steroclime test is a sensitive measure of Quadriceps strength and sensitive to testosterone and androgen anabolic stimulation. And it's also a test that the FDA told us in writing is the acceptable function endpoint. To pause for a moment. As you know, there are many of you may have heard, like Grip strength and leg press and Chess press, the FDA told us those are not acceptable functional endpoints. So the functional endpoint that we've chosen in the study, Seraphim Power is accepted by FDA. In fact, TavoPharma with F had the muscular dystrophy drug approved. I guess about 6 months ago, and so I think that's key. The other thing that's key in those 5 clinical studies that we did in almost 968 patients, about 900 of those patients, we did sterclimb. So we know how to do stair-climb we've learned a lot on how to execute on that endpoint. Dr. Barnette, do you want to add to anything to that?

No, yes, that's exactly right. And we're looking for changes in lean mass. We're looking for maintenance of lean mass in our treated group versus a loss in mass in the placebo group, and we're looking to assess how much we can offer it to fat loss. That's the main focus of this study.

And the next question comes from William with B. Riley Securities.

Congratulations on the quarter. Just looking for a little extra color here on what we might expect in January for the top line data. Is this going to be like simply lean mass loss being reported? Or will you provide any extra details on the body weight loss and/or the fat loss war specifically the functional improvements?

Yes. Great question. So the question because you're a little garbled, but I think the basic question is that I heard is that when you report in January, what can we expect in terms of top line data and the kinds of top line data that we'll get. And the answer is, for sure, and I say it this way because the rock depends on or concern that if you report too much information, then all of a sudden now you can't get all the societies and stuff you don't want you to, I mean, you have to have a scientific meeting with new information. So with that said, the most important thing about the trial is reporting out on body composition. So certainly, the primary endpoint of lean body mass and total fat mass. So you have a clear understanding of our dose response or the right dose to pick for the right preservation of muscle and reduction of fat compared to placebo. So we'll have that for sure. And then we'll just we'll just have to see how the societies and additional scientific meetings and that kind of stuff, what we can report. But as you know, in the spring time in the winter time, there are a lot of meetings that will be going on. So it's not right on the top line data happening in January, it'd be shortly thereafter in one of the major meetings.

Got it. Very helpful. And maybe actually just a quick question. I believe you mentioned that you're going to have a presentation at obesity week. You mentioned the abstract. Is this going to be, I would say, unseen data from past clinical trials? Or is it going to be a little bit of what we've been seeing or potentially what we've seen already?

It will be additional data that you have not seen. It's another analysis looking at data. So it's not repeat data that we've already shown. So it will be new data from the old studies.

Okay. Helpful.

[Operator Instructions] And the next question comes from Dennis Ding with Jefferies.

This is Anthea on for Dennis. 2 from us. On Star claim Power, could you talk a little bit about what the MCID is for the measure and what would be a successful outcome in Phase II? And on the Phase III, you've spoken previously about moving forward in elderly patients only versus the broader obesity population. Can you just let us know your thinking there and how the Phase 2 informed that decision.

Great. So I'm going to take the second question first and then Dr. Barnette will talk about Star Claim Power in terms of what's deemed a success. So in terms of the study, so to be very clear, the FDA has told us that the Phase III program that they're looking forward to us having the opportunity to develop the drug in all patients that have obesity or overweight. So in other words, all comers. And their belief is that a muscle preservation drug will have benefit in older, it has benefited all the patients will have benefit in younger patients, too. And so that's a positive sign that the FDA is well aware of body composition and how they're thinking about it. The FDA also said that one way forward would be to look for incremental weight loss, and this is now to about Phase III programs now, incremental weight loss the combination versus the Glp alone. The incremental weight loss, the FDA did not commit to how much weight loss, incremental weight loss you should demonstrate because their position is that because you have a muscle preservation drug that may benefit in other ways such as physical function, home IR, Gary Nachman brought up. There are other things, other benefits of having a muscle preservation drug that's beyond just the adding muscle or preserving muscle just for the sake of doing it. So showing function is important. And so in a Phase III program, having those endpoints as key secondary endpoints and the primary endpoint wave loss allows the FDA to look at the totality of the data for clinical benefit and clinical meaningfulness, which is good because at one point it was a direct cutoff on weight, and that was it. But now it's much more totality of the data. So what will inform us in this study, the Phase II is not whether we're going to go after an older patient population. This study is meant to ask a question in an informative patient population, meaning doesn't it make sense that if you want to show a benefit in physical function, you pick patients that already have muscle loss and may already have functional limitations. And if you treat them with an anabolic agent, selective anabolic agent like enobosarm that you show a benefit in physical function. So you're going to more likely show that in older patient population, which, by the way, in the 950 some-odd patients, we've done 5 clinical studies, they were older patients. So we have experience with all the patients and older patients with at least certainly with the 3-milligram dose totality of the data shows that we hit function. So that would make sense. As you start thinking about a Phase III program, again, the totality of the whole approach would be to go for all comers. And so Gary, if you don't mind, can you comment on success, Gary Barnette, our Chief Scientific Officer. Can you comment on the success? What would be considered success with StarClient power? And then second, how we're thinking about the Phase III, the development program as it relates to all comers, but also having the subgroup for the older patients. Curious.

So in the Phase II study, I would believe the success really is being able to power and inform the design of the Phase III. That's the success. And success as far as numerically goes, I think any separation from between the placebo group and the Enobosarm Treaty Group would be a success meaning we can show an observational difference between the power exerted going up the steps between the 2 groups. I think that would be a success. Remember, we're looking at change from baseline. So we've got a baseline value. And then we have a value 16 weeks, and then we'll have another value at the end of the extension. And I really think that the definition of success would be that we could observationally see a difference. As far as the Phase III trial, I think we're going to propose to the FDA and what we're going to try to do is we're going to power the Phase III study on, with the overall, remember, the FDA basically has told us that they believe that weight, or excuse me, the muscle loss or a drug to preserve muscle or preserve lean mass would be beneficial regardless to age, but they certainly recognize that the most at-risk patients are the aged population, which were study in the Phase II. So we do want us to include the younger patients in the Phase III study. So I would probably propose at this point that we would have a body weight endpoint, total body weight endpoint as the primary in the overall population. And then I would power the subgroup, meaning the patients over the age of 60 for airtime power because that is the at-risk population. So we intend obviously, if these patient populations have already lost lean as just due to their advancing age, and then we accelerate that with a grip 1 or a diet like this, then I think that that's where the value of Enobosarm increasingly math, increasing physical function is going to be the most important from a patient outcome and quality of life.

And let me also add, Gary, that the Phase III program is going to be done like a typical Phase III program. As you know, we're looking at 16 weeks. And the reason we picked 16 weeks for Phase II is for 2 reasons. One is we know about half the total weight that's lost in a trial that goes on for 68 weeks happens in the first 16 weeks. And we also know from bariatric surgery data that in the first 3 months, the 55% of the muscle you lose in that whole year post surgery, it happens in the first 3 months. So we know there's a lot of activity going on in muscle in that first 16 weeks. And we've got between the STEP 1 data and now the bariatric surgery data that gives you clarity on what's happening earlier. So the Phase 2 will help us understand what we want to do Phase III. Time for the Phase III would be if we use semaglutide or tousepatide and probably use both. The first 16 weeks is what you need to titrate up and then you go on for another year. So it's about 68 weeks. So your Phase III program would be 68 weeks and your functional endpoint will be at the end of that 68 weeks. So you have a lot more time to maintain muscle and separate out the placebo group. And so the way to look at it is the Phase II is just the beginning. And the 1-year study will allow you to see the additional fat burning benefits of having a drug that directly reduces fat we're having a glucagon receptor agonist that it's not going to have a competing signal we clinched stop eating and the competing signal is going to be the muscle deprivation deficit tolling to bring to eat because that's self-preservation you get rid of that noise than the Glp one can work better. And finally, with more muscle, you lose more fat. So that's why we think weight losses and endpoint and particularly is a good endpoint. And particularly now the FDA is thinking about clinical benefit is not just weight loss. It's wage laws in our case, function. And so I think it puts us in a good position. Also, the label will reflect that because again, the FDA doesn't really see muscle loss for cosmetic reasons, they see muscle preservation for functional reasons. Long answer, but hopefully, I gave you some clarity.

Okay. Ladies and gentlemen, this concludes the 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 at our next investors call. Thank you again. Bye now.

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