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 that this event is being recorded. I would now like to turn the conference over to Mr. Sam Fisch, Veru 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 of 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 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, our Chief Scientific Officer; Michele Greco, Chief Financial Officer and Chief Administrative Officer; Michael Purvis, our 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 Phase IIb QUALITY clinical trial top-line results call. Veru is a late clinical-stage biopharmaceutical company focused on developing innovative medicines for high-quality weight loss, oncology, and acute respiratory distress syndrome. This morning, we announced positive top-line results for our Phase IIb QUALITY clinical study. About two to three years ago, GLP-1 receptor agonist came on the scene as a very effective drug for weight reduction. About 18 months ago, new concerns were raised about the non-selective tissue composition of the total weight loss caused by these GLP-1 receptor agonists. Based on a STEP 1 semaglutide study, 40% of the total weight that's lost at 68 weeks was discovered to be lean mass loss. This is particularly worrisome for older patients who are overweight or have obesity and who may already have low muscle reserves. As a call to action a little more than a year ago, and based on our extensive clinical experience with enobosarm in improving body composition in older patients with age-related and cancer-related muscle loss conditions, Veru redirected the development of enobosarm, an oral selective androgen receptor modulator, as a treatment to preserve and to augment fat loss in older patients who are receiving a GLP-1 receptor agonist for weight reduction in the Phase IIb QUALITY clinical study. We have now completed the QUALITY study. It's also timely that the FDA has just released this month the new FDA guidance for industry entitled "Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction." This updated FDA guidance, plus our own previous two interactions with FDA, provides clarity on how we view the development program for enobosarm as an adjunctive therapy to improve body composition by preserving muscle and augmenting fat loss in older patients who are overweight or have obesity receiving a GLP-1 receptor agonist for weight reduction. In this new guidance, FDA defines obesity as a chronic disease characterized by excess adiposity or body fat. So again, excess adiposity or body fat. They also provide their current thinking on the definition of weight reduction. FDA has stated, "Weight reduction is defined herein as the long-term reduction in excess adiposity (body fat) with a goal of reduced morbidity and mortality." FDA also has further advised in its new guidance that "To ensure that a drug-induced or biologic-induced weight reduction is caused primarily by reduction in fat content and not lean body mass, a representative sample trial subject should have a baseline and follow-up measurement of body composition by DEXA or a suitable alternative." The conclusion that we believe is to be drawn by this FDA guidance is that there appears a company's weight reduction program is disadvantaged in FDA's analysis if its drug has adverse effects on body composition, notably loss of lean mass. To avoid confusion between the regulatory development pathway for weight reduction drugs and for drugs to improve body composition, FDA states that sponsors seeking an efficacy claim related to changes in body composition would need to consult the FDA early in development to align on the clinical condition being treated, trial design including appropriate choice of population, and selection of endpoints that measure how a patient feels, functions, or survives. So the indication that we're focusing on are older patients who have obesity or overweight and already may have low muscle reserves, who are receiving a GLP-1 receptor agonist for weight loss and who can benefit from a drug to improve body composition by preserving muscle and physical function while enhancing the loss of adiposity or body fat. We believe the market for this indication is quite large. Based on Medicare statistics, 22% of the U.S. Population is over 60 years of age, and according to the CDC, 42% of these older adults have obesity in the United States and could benefit from weight loss medicine. Up to 34% of patients with obesity over the age of 60 have sarcopenic obesity, which means sarcopenia being age-related muscle loss. This large subpopulation of sarcopenic obese patients is especially at risk when taking GLP-1 receptor agonist drugs for weight reduction 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 a GLP-1 receptor agonist therapy for weight loss, GLP-1 receptor agonist drugs may accelerate the development of frailty and muscle weakness in elderly patients who have obesity or are overweight. Fortunately, muscle weakness may lead to poor balance, decreased gait speed, mobility disability, functional limitations, loss of independence, and a high risk of falls and fractures. In fact, the safety section of the package insert for Wegovy has been updated based on a recently reported SELECT cardiovascular outcomes clinical trial, which now highlights a 400% increase in pelvic and hip fractures that were observed in patients greater than the age of 75 receiving Wegovy compared to placebo. That's 2.4% versus 0.6%. Fractures of the hip and pelvis typically occur because of falls, which increase with decreased muscle mass. Based on this updated FDA guidance, our interactions with the FDA, enobosarm is being developed as a body composition drug. Enobosarm is being developed as a body composition drug to preserve lean body mass, augment loss of fat in older patients who have obesity or are overweight and are receiving a GLP-1 receptor agonist containing the drug for chronic weight management. Now, we met with the FDA in designing our Phase IIb QUALITY clinical trial to gain agreement on a regulatory path with potential marketing approval for enobosarm to treat changes in body composition. The primary endpoint of lean body mass measured by DEXA was acceptable for a Phase II. If enobosarm preserves lean mass in patients receiving a GLP-1 receptor agonist for weight reduction, then a measurement of physical function by stair climb test power may be an acceptable performance study endpoint that captures the clinical benefit or the meaningfulness of muscle preservation. Today, we are pleased to announce the positive top-line clinical results of the Phase IIb QUALITY clinical trial. The Phase IIb QUALITY clinical trial is a multicenter double-blind placebo-controlled randomized dose-finding study to evaluate the safety and efficacy of enobosarm 3 mg and enobosarm 6 mg compared to placebo in 168 older patients greater than 60 years of age who are overweight or have obesity and who are receiving Wegovy semaglutide, a GLP-1 receptor agonist for weight reduction. The purpose of Phase IIb QUALITY clinical trial is to SELECT the optimal dose of enobosarm in combination with a GLP-1 receptor agonist that best preserves muscle and augments reduction of fat mass for better body composition, and this is with an endpoint of 16 weeks of treatment. The primary endpoint for the Phase IIb clinical trial is a change in total lean body mass from baseline to 16 weeks, and key secondary endpoints are the change from baseline to 16 weeks in total fat mass, total body weight, and physical function as measured by stair climb tests. So now turning to these exciting top-line results for the Phase IIb QUALITY clinical trial. Let's talk about the baseline characteristics. 14 clinical sites in the United States participated in the study. 168 patients were randomized to oral doses of enobosarm 3 mg, enobosarm 6 mg, or placebo at the time they initiate Wegovy or semaglutide for weight reduction. The study population baseline characteristics include 31% males and 69% females. For age, 80% were between 60 and 70 years of age, 13% between 71 and 75 years of age, and 7% greater than 75 years of age. For BMI, 14% was less than 30, 46% between 30 and 34.9, and 40% greater than 35. For race, 48% were non-whites and 52% whites. The dropout rate for the clinical study was 13%. In the press release, we have a table, top-line results table, that goes through the top-line results. Focusing on the top-line results, it's important to note that this Phase IIb QUALITY study is the first human study to report the effects of muscle preservation agent on body composition in older patients who have obesity or overweight and are receiving a GLP-1 receptor agonist first time. In the top-line efficacy analysis, the Phase IIb QUALITY clinical study met its pre-specified primary endpoint with statistically significant benefits in the preservation of total lean mass, with a 71% reduction in lean mass loss in all patients receiving enobosarm plus semaglutide versus placebo plus semaglutide at 16 weeks. The mean total lean mass percent change from baseline for all enobosarm plus semaglutide treated patients was minus 1.2% with an N of 100 versus placebo plus semaglutide alone subjects of minus 4.1%, N is 47. The p-value is 0.002, least squares means analysis. Secondary endpoint showed that the enobosarm plus semaglutide treatment resulted in a greater reduction in total fat mass compared to placebo plus semaglutide at 16 weeks. There was a 27% greater fat mass loss in all of the enobosarm treated patients compared to placebo plus semaglutide alone. And the mean total fat mass percent change from baseline for all of enobosarm plus semaglutide was minus 10.9%, N of 99, versus the placebo plus semaglutide minus 8.6%, N equals 48, p-value equals 0.096. Now, using absolute total body weight, this means all enobosarm plus semaglutide was 4.4 kilograms of weight loss and that's 100, and placebo plus semaglutide was minus 4.7 kilograms, N of 48. To provide context, the difference in absolute weight between all enobosarm plus semaglutide subjects versus placebo plus semaglutide subjects was just 0.3 kilograms in total body weight loss. As there were only minor changes in total body weight between the enobosarm plus semaglutide group and placebo plus semaglutide group at 16 weeks, this means that the enobosarm semaglutide treatment group compared to placebo semaglutide improved changes in body composition by preserving lean mass made up by the greater fat mass loss. In fact, the median percentage of total weight loss that is due to lean mass is 32% in the placebo plus semaglutide group versus 9.4% in the all enobosarm semaglutide group. In other words, of the total weight loss at 16 weeks, 30% of it contained lean mass for the placebo semaglutide group, and 9.4% was in the enobosarm plus semaglutide group. Therefore, enobosarm plus semaglutide improved changes in body composition, resulting in a more selective and greater loss of adiposity, that's fat, than subjects receiving placebo semaglutide. Another way of saying that is that you were able to spare lean mass and focus on removing the adiposity, which is what's the definition of weight reduction, getting rid of the adiposity and leaving the muscle of lean mass alone. Interestingly, we decided to use the loaded stair climb test, which is an eight-step stair climb test. It was conducted at baseline and at 16 weeks of study, and this is for us to measure function. Climbing stairs is an activity of daily living, and the stair climb test measures functional muscle strength, balance, and agility. The improvement in body composition and preservation of lean mass may be captured by measuring changes in physical function using the stair climb test. So the stair climb test had a responders analysis with a portion of subjects that lost at least 10% stair climb power at 16 weeks. So in other words, decline in function was the cutoff to decide how the patient's doing with stair climb. Interestingly, and this is the first study to show this, no other study has done a functional study with a muscle-preserving drug and semaglutide, but just semaglutide alone. In the older patients, this study showed that 42.6% of the patients experienced at least a 10% reduction in stair climb power from baseline, demonstrating that for the first time the loss of physical function has been tested and observed with a GLP-1 receptor agonist treatment. Now, interestingly, in the enobosarm plus semaglutide group, there was a 54% reduction in the proportion of patients with at least a 10% loss of stair climb power from baseline versus placebo plus semaglutide, and that p-value is 0.0049, so therefore, in the responders analysis, the proportion of subjects who lost greater than 10% stair climb power was statistically significant and clinically meaningfully reduced in the enobosarm plus semaglutide groups compared to placebo plus semaglutide. Now, what does this mean? The Phase IIb QUALITY study is the first human study to demonstrate that older patients who are overweight or have obesity receiving Wegovy semaglutide with GLP-1 receptor agonist were at higher risk for accelerated frailty and functional decline. Lean mass loss was significant. It's 32% of the total weight loss at 16 weeks with lean mass. Loss of lean mass also matters. It's 42.6% of patients on placebo plus semaglutide had at least a 10% decline in stair climb power. Our Phase IIb QUALITY study is also the first study to measure and to show the impact of lean mass on a common activity of daily living performance stair climb test. The potential for further reduction in physical function because of ongoing lean mass with chronic GLP-1 receptor agonist therapy is worrisome and must be evaluated. The expectation is that all GLP-1 receptor-containing drugs will cause significant loss of lean mass in older patients, raising concerns about declines in physical function, mobility, disability, functional limitations, loss of balance, with a higher risk of falls and fractures. The Phase IIb QUALITY study is also the first human study to report the effects of a muscle preservation agent on body composition in older patients who are obese or overweight and receiving a GLP-1 receptor agonist. In the intent-to-treat group analysis, the Phase IIb QUALITY clinical study met its primary endpoint with statistically significant benefit in preservation of total lean mass in all patients receiving enobosarm plus semaglutide versus placebo plus semaglutide at 16 weeks. Secondary endpoint showed that enobosarm plus semaglutide treatment resulted in reduction in total fat mass compared to placebo plus semaglutide measured by DEXA at 16 weeks. There appears to be minor differences in total body weight between the enobosarm group and placebo at 16 weeks. Therefore, the enobosarm in combination with semaglutide resulted in a better, higher quality weight loss defined as selective and greater loss of adiposity in subjects receiving placebo versus subjects receiving placebo and semaglutide. Further, the proportion of subjects that lost at least 10% of stair climb power was statistically significant and clinically meaningfully reduced in the enobosarm plus semaglutide groups compared to placebo plus semaglutide groups. Conclusion: We believe older patients who have obesity or overweight and are receiving a GLP-1 receptor agonist are an ideal patient population that has demonstrated in the Phase 2b QUALITY clinical study clinical benefit with enobosarm treatment to provide a greater quality weight loss as lean mass and physical function may be preserved with greater and selective loss of adiposity. That is, better body composition and weight reduction may be possible. Further, the expectation is that when patients are treated longer with enobosarm which we hypothesize would result in greater loss of adiposity, there would be also greater weight reduction than semaglutide alone. Safety: Well, as you know, the study is continuing as an extension study and it's blinded, so the safety data remains blinded in the ongoing study, and the unblinded safety data set will be available when the phase 2b extension study is done in April of 2025. However, the aggregate blinded data has not shown significant differences compared to previous studies of enobosarm. Further, the Independent Data Monitoring Committee met in October of 2024 to evaluate the unblinded safety data, and they made the recommendation to continue the study as planned. As a reminder, enobosarm has a large safety database which includes 27 clinical trials involving 1,581 mostly older men and women, some of which included patients dosed for three years. In this large safety database, enobosarm was generally well tolerated with no increases in gastrointestinal side effects. This is important as there are already significant and frequent gastrointestinal side effects with a GLP-1 receptor agonist alone. The company plans to present the full clinical efficacy and safety data set for the Phase 2b QUALITY clinical study in future scientific conferences and publications after the phase 2b extension portion of the study is completed and unblinded. Now, how about our next regulatory steps? Well, as a reminder, the phase 2b extension clinical study where all patients have stopped receiving a GLP-1 receptor agonist but continue to take placebo, enobosarm 3, or enobosarm 6 for an additional 12 weeks is ongoing. The blinded phase 2b extension clinical study is asking a different question than the Phase 2b QUALITY clinical study which evaluated the ability of enobosarm to improve body composition changes associated with GLP-1 receptor agonist weight reduction and loss induction. The phase 2b extension study will evaluate the maintenance of weight loss, meaning whether enobosarm can maintain lean mass and prevent the fat weight gain that occurs after discontinuing a GLP-1 receptor agonist. Successful, this would provide another important obesity-related indication for which enobosarm could be considered. The top-line results of the separate blinded phase 2b extension clinical study are expected in April of 2025. As the phase 2b QUALITY study has positive clinical top-line results, we're planning to move forward to request an end-of-phase 2 meeting with the FDA. In the new weight reduction FDA guidance, the FDA makes a regulatory path distinction between weight reduction drugs and drugs for body composition changes, and based on this guidance, enobosarm is being developed as a body composition drug to selectively preserve lean body mass and physical function and augment fat loss in older obese overweight patients receiving a GLP-1 receptor-containing drug for chronic weight management. We previously have met with the FDA to discuss our regulatory path forward as an improvement in the body composition drug, and the FDA has provided general advice on the phase 3 design. Based on the phase 2b clinical trial, the proposed phase 3 clinical trial design is currently expected to be a double-blind placebo-controlled study in patients older than 60 years of age, patients who have obesity or overweight, and who are eligible for treatment of a GLP-1 receptor agonist. The GLP-1 receptor agonist may be either Wegovy, which is semaglutide, and/or Zepbound, which is tirzepatide. Patients will be randomized to oral daily doses of enobosarm or matching placebo. The proposed primary objective will be the effect of enobosarm on stair climb power is measured by the proportion of subjects that lose greater than 10% stair climb power from baseline. The proposed key secondary objectives will be to assess the effect of enobosarm on total lean mass, total body weight, total fat mass, bone mineral density, HOMA-IR, which is insulin resistance, and hemoglobin A1c. The duration of the trial is expected to be 52 weeks, which allows us to also capture the benefits of enobosarm improvement on body composition for greater loss of adiposity and weight reduction. Based on responders analysis of stair climb power observed in the phase 2b clinical study, the predicted trial sample size is expected to be approximately 470 total subjects with 90% power and two-sided alpha of 0.05. The estimated cost is approximately $40 million over an expected 18-month period for a single phase 3 study of this design. We expect the end-of-phase 2 meeting with the FDA will occur within 90 days. Our financial position as of September 30th. Veru had $24.9 million of cash on hand, and the company sold the FC2 business in December of 2024, which netted approximately $12.5 million. We have sufficient resources to get beyond April 2025 top-line results, as well as the FDA end-of-phase 2 meeting, which is expected in the second calendar quarter of 2025 and beyond. For more clarity, please call your attention that we'll be having an earnings call in February of 2025. With that, I 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 please pick up your handset before pressing the keys to ensure the best sound quality. To withdraw your question, please press star then two. Please limit yourself to one question and one follow-up. If you have further questions, you may re-enter the question queue. Once again, that is star then one to rejoin the question queue. We will pause momentarily to assemble our roster. The first question comes from Gary Nachman with Raymond James. Please go ahead. Hi, good morning, and congrats on the readout. Mitch, can you provide any color on the two doses, the 3 milligram and 6 milligram, and how they trended in terms of lean mass, fat mass, and function with the stair climb? Which dose or doses would you pursue in the phase 3? Are you contemplating just one dose with your proposed N of 470 patients? And then also on the total body weight loss, that was roughly the same in the two groups. With enobosarm, it was slightly less. Just how do you explain that? Was it because muscle weighs more than fat? Yeah, so I'll take your second question first. Again, you're talking about 300 grams and 168 patients difference. So I would say they're the same, and I would also say, well, that's pretty interesting because that means 38% in the semaglutide alone, 38% was muscle, and I guess the rest is fat and bone or something like that. And whereas the enobosarm group, it's 9%. So you had to make up for that difference to get to the same weight by losing fat. So that's great because you want to lose fat. That's the word quality. So quality is what's important. And so we hit our mark, right? I mean, we've been saying all along that the only way you can get to the same weight at 16 weeks when you're free-falling, remember the way the curve goes, you free-fall for 16 weeks and hit a plateau, and then you lose the other half of your weight over the next year. So the free-fall was not interrupted, and you ended up with what? 9% muscle loss in the fat and in the weight, total weight loss as opposed to 38%? And the other thing it teaches you is that muscle loss tracks with weight with semaglutide. No one's really looked at what happens early on. All we know is that if you have a 40% loss of muscle, 40% of your total weight loss contains muscle at 68 weeks. Well, what happened along the way? We now know that. It happens early. So to answer your question, I feel pretty good that we've got a real body composition drug. And this goes on the heels of the fact that you talk about dose. Now, this is top-line data, so I'm going to try to give you some clarity on dose so that you can have a feel for it. As you know, when we designed this study, the goal was to modify body composition. We know from the 1,000 patients of data and five clinical studies that the 3 milligram dose works. It works. It does a great job. We also know from our previous studies, like the MAD study, that if we keep going up on dose, you can hit a plateau, right? It makes sense because at 3 milligrams, you're really oversaturating the androgen receptor in muscle. So why, Mitch, did you go to six? Well, you've heard me say this before. We went to 6 milligrams because it turns out the androgen receptor sits in fat. And if it sits in fat, then you need a higher concentration of drug to saturate those receptors in fat because the fat compartment is so much larger. So that was the working hypothesis. And it turns out that's exactly what we saw. So without kind of giving you the exact numbers, I want to have some things to share with you later. The three milligrams did beautifully. The p-value was less than 0.001, and so the three milligrams didn't disappoint. It worked. And the six milligrams was not better than the three. So it's not a surprise I said that. And interestingly, for fat, there was a dose-dependent reduction in fat, and the dose-dependent reduction in fat at six milligrams was better than three, that played out. So what was that p-value? That p-value was 0.014. So in fact, you went from 27% to almost 48% reduction of fat at the six milligram dose. So it played out exactly as we set up the trial. So it gives you some flexibility as you think about the right dose. I won't be able to comment on what dose is the right dose yet until we get the full data set. But at this point now, three didn't disappoint in muscle, and boy, it was a nice surprise to see more fat loss with the six milligram. As it relates to stair climb function, we showed you the data based on the cutoff. As you notice, as responders analysis, you pick a point that you think describes what you want to measure the individual patients can achieve. So if you think a minus 10% reduction in power and function is meaningful, which minus 10% is pretty meaningful, then how many people fell in that bucket? That answer is 42 point, whatever number I gave you is 42.6% of the semaglutide alone hit that. That's almost half your patients are having a 10% decline at 16 weeks. I mean, there's some criticism at 16 weeks long enough to see physical function. We saw it. It's there. Stair climb is a pretty sensitive, valid, and reliable way to measure this, and it played out. The question is, how did it look for the doses? Well, for all of them, it was about a 50% reduction. And it turns out for the 6 milligram and for the 3 milligram, there were also statistically significant reductions in the number of patients in the enobosarm group compared to the placebo group, meaning that 50%, sometimes much higher% of patients in the enobosarm group did not hit 20%, excuse me, 10% loss of function, meaning that you had a reduction in the number of patients that were in that category by 50%- 60%. That number was highly statistically significant with p-values of 0.00, whatever. So they're not officially exact. So I'm saving the actual details for future publications, but I wanted to give you some color. Okay, great. If I could just ask one quick follow-up. So you expect the phase 3 trial to be 52 weeks. How do you think that the drug will trend when you just go farther out from the 16 weeks on the key endpoints? So were you seeing continued improvement as you got to the 16 weeks? We obviously don't have the benefit of seeing the charts and the trend over the 16 weeks, but your confidence that you would see continued improvement when you go farther out. Thank you. Yeah, yeah, yes, and so let's take it in pieces. So lean mass, the idea is to maintain lean mass. Remember, I keep saying I'm not trying to make bodybuilders. So can we maintain lean mass? The answer is it looks like you can maintain lean mass. That trajectory looks like it's going to be fine. The next question is, can you lose more fat over time? Well, the trajectory is now pointing down, meaning you're losing fat. And if you're losing fat and you keep doing that for another eight months, call it, for 52 weeks, so if it goes for another eight months, then the expectation is the weight loss that you're losing, if it's 9% lean mass and 91% fat, you're going to be burning a lot of fat. Remember, the goal is to break through that plateau. So I'm feeling pretty good that the fact that we're seeing the fat is responding so nicely to the direct effects. It could be direct effects of the GLP-1 being able to work a signal for muscle. It could be direct effects of enobosarm directly on the fat itself. It can be, in fact, you have more muscle, you burn more energy. All of that leads to loss of, and we're seeing that. We're seeing that in this study. So the expectation is with longer follow-up that we're going to get a higher quality weight loss, and you could have potentially greater weight reduction at 52 weeks. But again, think about what we're doing. As a body composition drug, we're not asking the drug to hit some magic number of how much more additional weight loss you need to hit it a year because the FDA doesn't even know what that number is or if there is a number. However, we hit our functional endpoint for every one of our two doses plus all enobosarm. So for physical function, we were able to measure the lean body mass benefit. So that's your primary endpoint. Remember, the FDA wants to know how a patient feels, functions, and survives. Function, function, function. We hit function. We measure function. That's going to be the primary endpoint. And then you can measure fat and lean mass and weight. And so then that becomes supportive of your primary endpoint as opposed to turning everything upside down, saying, "Oh, we got to hit a certain amount of weight loss." I think the fact that we're able to make semaglutide a better weight loss drug means that potentially with any GLP-1 containing drug, we could do the same. And so we're not trying to develop enobosarm as a standalone drug. It's a drug that can be used in any of these GLP-1s. I don't know, 70 are in development now. All right, great. Thanks for all that color. Appreciate it, Mitch. Thank you. The next question comes from Dennis Ding from Jefferies. Please go ahead. Hi, this is, sorry, Anthea on for Dennis. Thanks for taking our questions. Just one on the stair climb power. Did you see any improvements from baseline as you saw in the phase 2? And then a question on the phase 3 design. I noticed that you're narrowing it now down to 60 years old and older. Is the all-comer population still on the table, or are you focusing more on the narrower, older population? Thank you. Great questions. Thank you. So for the first question, remember we did a responders analysis, and so you have to pre-specify. You don't look for cutoffs. You pre-specify your cutoffs, and our thinking was that we were going to maintain lean mass and have slight loss potentially of lean mass. The important thing was to see if we can stop the decline, and so that was the thinking behind picking the 20%. I do not have any information that was given to me in top-line about what happens with improvement. We picked detriment because the thought was that if you lost lean mass, you'll see detriment. If we had a situation where we did a 10% cutoff with decrease and nobody hit that, then we would have been in trouble. The fact that we had a 10% reduction in power, 43% of the semaglutide group hit that, that tells you that's a problem. To me, fixing a problem in decline in physical health is critically important in these older patients. And it would be nice to see in future studies whether or not over longer periods of time beyond 16 weeks that by maintaining muscle, that you may see an improvement in function, not just stopping the decline, which in itself is clinically meaningful. As it relates to your second question, which is it appears that the phase 3 design is focusing on older patients. Look, we had a very successful trial, and we picked older patients for all kinds of reasons. And the reason we picked it most is because if you want to find a problem with muscle, go after patients that may have a problem with muscle already, and then you add the GLP-1 and you make it worse. Well, that played out. In our database of the five clinical studies in almost 900-1,000 patients, they were mostly patients over the age of 60 and older men and women. And we hit, I mean, three milligrams did great. I mean, that's why we bridged with three. And guess what? It hit again in different patient populations and older patients. So we have a drug that's shown not only in this trial, but in previous trials, it's the right drug to change body composition. So the other thinking is that if this is the experiment that worked, and this is a patient population of need, and you can have a very nice clinical benefit versus risk ratio because you're going after something in patients that are already in trouble or getting into trouble, that feels better for a phase 3 program. Furthermore, the phase 3 program, you're trying not to change the experiment. So if you were successful in your phase 2b, then let's replicate that because that's a clinically meaningful group. It's a subpopulation that's large, and they're already more likely to get into trouble in the time span that we're testing them. Now, the all-comers is off the table from a standpoint of efficacy because our feeling is with limited resources, let's get this indication to the marketplace, and then in the future, we can always expand. Got it. That's helpful. Thank you. And if I could also ask a follow-up, in your prior interactions with the FDA, is one phase 3 sufficient for approval? We don't have that. We don't have that clarity at this point. Okay. Got it. Thank you so much. Great. Thank you. The next question comes from William Wood with B. Riley Securities. Please go ahead. Thank you, and congratulations, and I appreciate you taking our questions today. We know that the study remains blinded, but I was curious if there was any extra color you could provide on safety, specifically GI tolerability since the concern with GLP-1s, and then also in terms of liver enzymes that may have been reported thus far, whether they've been in line or if you have any granularity on if they're in line for both enobosarm and placebo groups. Yeah. So GI tolerability, first of all, thanks for the question. First of all, it's blinded. So as you know, by definition, the GLP-1s have GI toxicity or side effects. So our placebo group is not placebo. It's placebo plus GLP-1. And our treated groups all have GLP-1. So we're not going to be able to tease out the GI tolerability piece until we unblind the study. As it relates to liver enzymes, as I said in my comments, we're just not seeing anything different in the current study in the aggregate blinded data versus what we've seen before. But I have Dr. Gary Barnette, who's our Chief Scientific Officer, make a comment. Yeah. Thank you. Yeah. As Mitch mentioned, we're not really seeing anything in the blinded aggregate. As you know, in the Wegovy PI, about 3% of the patients in Wegovy alone had significant ALT increases. And of course, we've seen transient increases in the past. We continue to have no drug-induced liver injury by Hy's Law that's been observed in the study. So it's really not different than what we have expected and observed in the past studies. Okay. I appreciate that. That's very helpful. Then additionally, I know for your phase 3 trial, you SELECTed stair climb power as measured by greater than 10% power from baseline. With the updated FDA guidance, as you mentioned, but also just in terms of what we've seen from, I'll call it, improvements in six-minute walk tests, specifically from just Wegovy-treated patients by themselves with nothing else. Could you maybe discuss what the FDA has said about stair climb power endpoint versus, say, a six-minute walk test and what that means in terms of functional benefits for a given patient? Yeah. It's a good question. And so when you look at anabolic agents like testosterone, it's very hard to show benefit in a six-minute walk test. Six-minute walk test is typically used for cardiovascular outcomes. And so if you look at, for example, pulmonary artery hypertension and all the cardiovascular drugs that use a six-minute walk test, it is an improvement. A six-minute walk test really is looking at more endurance than the short burst that you would take to get out of a chair, get out of a tub, or go up the stairs. And so if you want to measure that, the stair climb power is a much better test because, I mean, you can have somebody who's an endurance runner with not much ability to lift weights. And so we're trying to find the patients that can lift weights, use their legs to go upstairs. That's a different kind of stress. The FDA has not opined on that, but I will tell you that they did tell us that grip strength, leg press, chest press, having nominal changes in that, they don't view those as functional tests. And so stair climb test, we've actually, in my previous company, used it as a co-primary in the phase 2, phase 3 programs, and the FDA was fine with that. And stair climb test is a couple of muscular dystrophy drugs have been approved on stair climb. So it does have a regulatory acceptance pathway. And the FDA did comment that if we showed meaningful changes in stair climb power, then that could be clinically meaningful versus looking at additional weight loss because the concern was that people were saying, "Oh, you need to show more weight loss, more weight loss, more weight loss." The world's turning. It's not all about weight loss now. It's about losing weight in a healthy way. The journey has to have more quality. If you can lose the same weight or more, we hold on to muscle and make it mostly fat, which by definition is what obesity is about. It's about the excess adiposity. Then that would be a great thing, and so the fact that we're coming in with an endpoint for physical function and show that we lost more adiposity and the adiposity with time because usually you have to look at the year, you'll see even more weight loss, then it takes us out of that bucket of how much more weight loss do you need. Now the question is, you stopped the decline, you lost more adiposity, you held on to lean mass, which has its own benefits. Oh, by the way, and you lost a lot more weight versus, oh, you haven't hit some critical cutoff point for weight loss, which the FDA has not even defined because they still can't understand what's the difference between 10% and 5% and 15% and 20%. It's something we're doing in industry. But from an FDA standpoint, they don't understand the clinical meaningfulness of adding 5 more% to improve drug that's already at 10 or 15 or 20%. So I would say that the six-minute walk test should be better in these patients because you are making them cardiovascular better. But that's the same patients we have in our study, and we were able to tease out that stair climb test is not better in the GLP-1 alone. Got it. Appreciate that, Mitch. And actually, just one quick last one. Will the phase 3 have a maintenance portion or a follow-up after the 52 weeks? And then I'll hop back into queue. I love your questions. I think we should keep the phase 3 simple. And so I'm never going to say never, but I think initially, the goal is to kind of treat these as separate programs, meaning the induction program, which is the phase 2b that we just did, where we're trying to show that when you start a GLP-1, you can make a better weight loss journey by better body composition, and that will see better function. It's really a separate question, separate phase 3. And then the maintenance one is asking the question, well, gosh, if the hypothesis is true that you lose muscle and you have your muscle depleted, so when you stop the GLP-1, you have that rebound weight gain and you overeat, trying to put muscle on, you end up putting mostly fat. Well, that's a whole different group. Then in that case, you can go after patients that have been on GLP-1s, a much bigger patient population, and maybe a different kind of trial. So we're going to keep them separate for now. Got it. Thanks. And congratulations again, and thank you for taking our questions. Thank you. Appreciate it. The next question comes from Leland Gershell with Oppenheimer. Please go ahead. Hey. Morning, Mitch. Thanks for the availability and for taking our question. Just wondering, in terms of the safety data not being released yet, obviously a bit atypical from an investor's perspective, is that something that was required for you to maintain a blind for the second part in terms of the protocol? Was there any option for you to have disclosed the safety data from the first portion? Remember, this is a good question, so remember, this is an atypical study, right? Because we have a phase 2b, and then you roll everybody over to an extension study, do you want to keep blinded? So most studies will say, okay, here's your study, and then you do an open-label extension study or something like that, in which case you get all your safety data. But we didn't want to do that. I mean, if you start undoing the blind in this study, I mean, you're going to have investigators and patients, and the quality of the study will be impaired. And we don't want that. We want the best study we can run. And so we've been very, very, very careful. So with that said, the safety data stays blinded. And I think we've given you a good representation of what we're seeing in the aggregate. But in fairness, we can't separate out the GLP-1 by itself versus the enobosarm. All we can tell you is that we're not seeing things that we haven't seen before with enobosarm. And so there's nothing surprising. I know one company ends up seeing things in the combination of the GLP-1 plus their drug that caused concern. We're not seeing again, we don't know who's on the bus, but we're just not seeing that. So we just have to wait till we get it unblinded. I mean, looking at what, April, May, right? So you're talking two, three months. We'll have the full data set. And that's why I'm not talking about which exact dose we're going to go forward with, the three or the six, because we need to look at safety, we need to look at efficacy, and we need to look at the full data set on an individual basis. And because you can choose one or the other. I mean, there's some qualities I like about both. But as you know, the FDA typically likes the lower efficacious dose. So in that case, the FDA would probably gravitate towards the three. And three does fine. Yeah. No, and that's useful for my follow-up, which is you're seeing preservation of lean mass with the three. It doesn't seem like it's much incremental with the six, but you do see, obviously, much better fat mass loss with the six. Would it be fair to say that I think at 16 weeks, right? Would it be fair to say that sort of the, I don't know, the view would be kind of the default view would be that if it's 3 milligram, go forward. Yeah. 6 milligram, less likely or unlikely. Yeah. Yeah. Yeah. So again, no answer except that you're thinking about, right, get more information. Because I would argue that with greater fat loss with the 3 milligram happening just by the nature that you go from 38% lean mass loss in the semaglutide alone to 9% lean mass loss with the aggregate. And the three, I told you, looks great. So it's going to be in that range of less. Then that means that what's left is fat, and you're losing a lot more fat for your buck. So do that over time. That should be interesting. Great. Thanks for taking the question. Thank you. Again, if you have a question, please press star, then one. To withdraw your questions, press star, then two. The next question comes from Yi Chen with H.C. Wainwright. Please go ahead. Yi? Excuse me. Yi Chen, your line is open. I guess it must have fallen out. Okay. Then what we'll do at this time is, 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. Very, very excited about our Phase IIb QUALITY clinical study. The results of the study are very consistent with the hypothesized outcomes that we expected. And they have a body composition drug that allows you to be more selective in your tissue loss so you can lose fat and leave muscle alone, is what we were trying to do. And that's what enobosarm accomplished. And so we feel pretty good that we now have shown, for the first time, in patients who are on semaglutide that there's a problem. And we're now showing that semaglutide versus enobosarm addresses that problem and allows us, in a way, from a regulatory standpoint, to go forward in a different way that gets us to market, ultimately, to be a drug that's used in all patients that are on GLP-1 for weight reduction. So with that, I appreciate everybody who joined us on today's call. I look forward to updating you on our progress. In the next investor call, we'll give you more information along the way as we unblind this study and get more data, and then, of course, in April, we have the phase 2b extension study that we'll be reporting out, so thank you again for being on today's call. The digital replay of the conference call will be available beginning approximately 10:30 A.M. Eastern Time today, January 27th, by dialing 1-877-344-5729 in the U.S. and 1-412-317-0088 internationally. You will be prompted to enter the replay access code, which will be 963-7754. Please record your name and company when joining. The conference has now concluded. Thank you for attending today's discussion. You may now disconnect.