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 0. 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 call over to Mr. Samuel Fisch, Veru, Inc's Executive Director of 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, 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 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 Michele Greco, CFO and CAO, Dr. Gary Barnette, Chief Scientific Officer, Dr. Domingo Rodriguez, EVP, Global Clinical Operations, Dr. Gary Bird, EVP, Quality and Regulatory Affairs, Dr. Harry Fisch, Vice Chairman and Chief Corporate Officer, Michael Purvis, EVP, General Counsel and Corporate Strategy, and Sam Fisch, Executive Director of Investor Relations and Corporate Communications. Thank you for joining our call. Veru is dedicated to the development of novel medicines for the management of the two most prevalent cancers, breast cancer and prostate cancer. One of our anticancer drugs, sabizabulin, has dual antiviral and anti-inflammatory effects, so is also being developed for the treatment of hospitalized moderate to severe COVID-19 patients at high risk for acute respiratory distress syndrome and death, which remains a global dire unmet medical need.
This morning, we announced that the Independent Data Monitoring Committee has conducted a planned interim analysis of our phase III COVID-19 clinical trial and unanimously recommended early stopping of the study because of evidence of overwhelming positive efficacy. Sabizabulin disrupts intracellular transport of the coronavirus along microtubules. This is a highly conserved biological process that is required by all variants of COVID-19, including Omicron, to cause infection.
While there have been recent developments evaluating, including the Merck drug molnupiravir and the Pfizer drug PAXLOVID for the treatment of unhospitalized patients with COVID-19 who are at a relatively lower risk of dying, sabizabulin, in contrast, is being developed for hospitalized moderate to severe COVID-19 patients who are at high risk for ARDS and death, patients for whom there are currently no clearly effective treatment in a population in which the Merck drug molnupiravir did not demonstrate efficacy.
Based on our positive phase II clinical study in hospitalized moderate to severe COVID-19 patients at high risk for acute respiratory distress syndrome that showed that sabizabulin treatment resulted in a significant reduction in deaths compared to placebo, we conducted a phase III COVID-19 clinical trial, which is a double-blind, multicenter, multinational randomized 2: 1 placebo-controlled study evaluating daily oral 9 mg doses of sabizabulin for up to 21 days versus placebo in approximately 210 hospitalized moderate to severe COVID-19 patients who had high risk for acute respiratory distress syndrome and death. Both the placebo and sabizabulin-treated groups were allowed to receive standard of care, which could include dexamethasone, remdesivir, anti-IL-6 receptor antibodies, and JAK inhibitors.
Moderate to severe COVID-19 symptoms means patients that are hospitalized, which means WHO criteria greater than or equal to four, and require supplemental oxygen up to mechanical ventilation or ECMO. Furthermore, one of the inclusion criteria is the patient must have a peripheral capillary oxygen saturation of less than or equal to 94% on room air. This is a very sick patient population at high risk for ARDS and death. The pre-specified primary efficacy endpoint is the proportion of patients who die on study up to day 60. Secondary endpoints include the proportion of patients without respiratory failure, days in the ICU, WHO ordinal scale for clinical improvement change from baseline, days on mechanical ventilation, days in the hospital, and viral load. The study was conducted in the U.S., Brazil, Argentina, Mexico, Colombia, Bulgaria, and COVID-19 infections in the study included the Delta and Omicron variants.
In January, the FDA granted Fast Track designation to the phase III COVID-19 registration program. Fast Track designation aims to expedite the development and review of new drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to fill unmet medical needs. Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may potentially be better than available therapy. Thus, having Fast Track designation is a distinction that underscores the urgent need for new, novel, and effective therapies to use along with vaccinations to combat this COVID-19 pandemic. On April 8th, 2022, the independent data monitoring committee conducted a planned interim efficacy analysis in the first 150 subjects enrolled in the phase III COVID-19 study.
After reviewing the unblinded clinical data, the independent data safety monitoring committee unanimously recommended that the phase III study be halted early due to overwhelmingly positive efficacy. They also remarked that no safety concerns were identified. The pre-specified primary endpoint was death at or before day 60. Sabizabulin treatment resulted in a clinically and statistically meaningful 55% relative reduction in death with a p-value of 0.0029 in the intent-to-treat population. The placebo group with n=52 had a 45% mortality rate compared to a 20% mortality rate in the sabizabulin treated group, n=98. The placebo group rate of 45% underscores how sick these patients really are.
The poor outcomes demonstrate the inadequacy of the current standard of care, which could have included dexamethasone, remdesivir, and anti-IL-6 receptor antibodies, and JAK inhibitors. Again, the addition of sabizabulin reduced death by 55% in this critically ill population. The secondary efficacy endpoints are still being analyzed at this time. Sabizabulin treatment was well tolerated in this patient population with no clinically relevant safety observations in the sabizabulin treated group compared to placebo. The company plans to meet with FDA to discuss next steps, including the submission of the emergency use authorization application. We will also begin to plan for regulatory submissions outside the United States. The company has scaled up manufacturing processes to produce commercial drug supply to address anticipated drug needs following any potential FDA authorization.
We have been in discussions with BARDA and other U.S. government agencies in an effort to secure an advanced purchase agreement of drug product for the U.S. COVID-19 global cases, hospitalizations, and deaths continue to be high. New variants of COVID-19 are brewing. COVID-19 surges will happen. New York and Washington, D.C. have seen a doubling of new cases of COVID-19. Vaccines are not enough. Some of the antibody drugs are not effective against the Omicron variant BA.1 and BA.2. COVID-19 is surpassing two years as a pandemic and does not appear to be going away. It is clear that an effective and safe oral therapeutic that prevents deaths in hospitalized patients with moderate to severe COVID-19 infection, who are at high risk for ARDS and death, is desperately needed.
We strongly believe that sabizabulin, with its dual antiviral and anti-inflammatory properties, and with these phase III efficacy and safety results, can be that greatly needed oral therapy for hospitalized patients with moderate to severe COVID-19 as a new standard of care. We will continue to update you on the regulatory progress towards the emergency use authorization, manufacturing, additional clinical data releases and publications, BARDA discussions, our U.S. and global distribution plans, and our partnership discussions. We're committed to driving shareholder value by developing and commercializing novel medicines addressing significant unmet medical needs. With a positive phase III study, we will advance and seek regulatory approvals and the commercialization of sabizabulin 9 mg for hospitalized moderate to severe COVID-19 patients with high risk for acute respiratory distress syndrome and death.
Sabizabulin has the potential to satisfy an important unmet medical need and to become a new tool against moderate to severe COVID-19, and potentially for other serious viruses that utilize microtubules to cause infection and death, including influenza virus, Ebola virus, and many others. Finally, I would like to say I'm so proud of our team that has stepped up to the challenge. We were duty-bound, we fought, and we succeeded. I would like to thank Dr. K. Gary Barnette, Chief Scientific Officer, Dr. Domingo Rodriguez, the EVP of Global Clinical Operations, Dr. Gary Bird, EVP of Quality and Regulatory Affairs, Amy O'Brien, the Senior Manager of Clinical Operations responsible for the phase III clinical study, Chris Hitchens, Denise Pattavina, Johanna Sanchez-Adams, Sandria Elrod Iqbal, Adam Mann, Worldwide Clinical Trials, August Research, CoreRx, and Olon Ricerca Bioscience.
I would also like to thank all those folks at Veru that supported the effort. With that, I'll now open the call to questions. Operator?
Thank you. Ladies and gentlemen, at this time, we'll begin the question and answer session. To ask a question, you may press star then one on your telephone keypad. If you're 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 reenter the question queue. Once again, that is star then one to rejoin the question queue. We will pause momentarily to assemble our roster. Our first question comes from Leland Gerschel from Oppenheimer. Please go ahead.
Hi, good morning. My congratulations on this terrific data and much needed. Wanted to ask a couple questions. First, Mitch, could you comment on how long on average patients were on sabizabulin? And also wanted to ask if you could just kind of walk us through
The emergency use timelines, you know, FDA meeting and thereafter, when could we see the availability of this drug? Thank you.
Sure. As you know, we just got the data on Friday, so we're still capturing it all. I can tell you in the phase II study, it was about 10 days on average, and we think it's gonna be similar in this study. It shows you how potent this agent is, that even though the patients could be on it for 21 days, you know, with 10 days on average, we were able to see this dramatic effect. As it relates to your second question, again, I will tell you, since we have Fast Track designation, we have been in constant dialogue with FDA. What we're doing now is we're pulling together the documentation that we need to have the first interaction, formal interaction with the FDA.
Hopefully, that'll happen, you know, this month. It will happen this month. Then at that point, we're gonna get to work to get this EUA application in. You know, the timing is depending on the FDA. As you know, an EUA application is not the same thing as an NDA, where you have, you know, PDUFA dates and all that stuff. They can, you know, be pretty short about it. They can take their time. You know, again, in a patient population where for the last two years nothing has really stepped up for a disease like COVID-19, that's probably the number one threat in the world.
The threat is the people that are dying. This is the space that we're in. If you look at the CDC guidelines, it's remdesivir and dexamethasone. That's it, for two years. This really represents a big step forward, and I'm hoping that will be reflected in the speed in which the FDA evaluates the EUA.
Thank you.
The next question comes from Brandon Folkes from Cantor Fitzgerald. Please go ahead.
Hi, thanks for taking my questions, and congratulations on the data. Maybe just curiously, at this stage, can you elaborate potentially on any difference in the two treatment arms and placebo arms on potentially different standard of care used in those arms? Was it pretty balanced across the arms? Just trying to parse out if there's sort of any difference-
Yeah, yeah.
In standard of care there.
Yeah. To answer your question, we did get that data. Even though it was the first look, there are no imbalances with males and females, and with standard of care, it's exactly. I mean, the system worked. The randomization worked, so there are no imbalances.
Oh, fantastic. Maybe just to follow up on your comment on the manufacturing capacity. You talked about, you know, that you have scaled up. Are you looking to partner this just given how big it could be? You know, I guess-
Yeah. It's a great question.
Getting up and manufacturing, what does that address? Maybe just given how large the potential could be.
Again, we're very fortunate that unlike some of these other agents, it's a 9 mg dose once a day. That's it. You're not talking about a handful of pills every day and taking pills to knock out P-glycoprotein and all that stuff. It's one pill a day. It's actually a capsule. The capsule can be opened up and put through an NG tube for somebody that's in the ICU, or they can take it orally if they can. It doesn't require cold storage, and it's not an IV. I'm going through this because part of manufacturing is all of the controls and the ways that you have to treat the material to get it from point A to point B.
Without the cold storage, I mean, you know, I mean, I exaggerate the point to make the point. You can put it on backpacks and get it to areas of the world that can't get it. It's a pill, so you don't have to give an IV, and it doesn't require cold storage and the whole bit. From that standpoint, it's really a simple small molecule. Since it's a simple small molecule, the manufacturing process is pretty straightforward. I believe it takes about five steps or four steps to make the drug. We have been incredibly robust in our manufacturing practices, and so we, you know, are in place to scale up to meet the world's demand.
As I mentioned, Olon Ricerca Bioscience is helping us with the U.S. Excuse me, helping us with the API, and CoreRx is helping us with the capsules. Both Olon Ricerca Bioscience and CoreRx will be U.S.-based, so that we can control the U.S. manufacturing of our products, so we're not looking for API coming from China or India. It'll be U.S. From that standpoint, it is not as overwhelming as you think. I think the manufacturing part of it is the easiest part. We can do that, and we've done that, and it's in place. The next part is distribution.
I think the most important thing about distribution is that this is hospital-based. This is not getting a doctor in a practice to write a prescription and sending a patient to a pharmacy. This is a patient that's hospitalized, on oxygen, going down the slippery slope to the hospital formularies is where this drug will be. As you know, hospital formulary distribution is pretty standard. Once you've plugged into the GPOs and all that stuff and you're on their formularies, you know, they just order it from the chart. The patients in the ICU, and this is part of a standard of care algorithm, then it'll be part of the standard care algorithm filled automatically in each of the hospitals.
Hospital fulfillment and distribution is very different than trying to get every pharmacy to have it stocked. It's a much smaller number, much more manageable number, doesn't require a sales force, and a few account managers follow up. Now, with that said, yes, it is big. What we... I mean, again, this is the biggest threat in the world right now. It's COVID-19. It's not only a threat to life, but it's crippling economies. It's been kinda. I mean, as much as we want, as much as we wanna wish it to go away, it just feels like it's not going away.
Even China, where COVID-19 originated, is, you know, shutting down again in big blocks and because, you know, even with the most drastic public health policies, they can't get it under control. With that said, we, you know, we're gonna do everything in our power to keep moving things. It's doable for us to move it, but it makes a lot of sense to, you know, to partner where it makes sense, or more so that we can make sure that this drug, you know, gets to every place in the world it can get to, and that we get through the regulatory processes of the U.S. and outside the U.S., as efficiently and quickly as possible.
You know, this is where hopefully government will step in and you know, for every one of these drugs that have come out, the Merck drug, the Pfizer drug, the vaccines, BARDA and other government agencies have stepped up with an advanced purchase order agreement. We you know, we're looking forward to the same thing because you know, this is the one that actually is its endpoint is death, not hospitalizations, days in the hospital, ICU days. It's death. You can't fake a death. It's a. It's you know, the efficacy is highly effective and more effective than what appears to be out there now today.
I, you know, we're up for the challenge, and we're gonna push hard. Yes, you know, partnerships along the way, whether it's regional or global, is just another way to get this important drug to patients.
Great. Thanks so much, Mitch, and congratulations to you and the team.
Thank you.
Our next question comes from Chris Howerton from Jefferies. Please go ahead.
Great. I will also offer my congratulations, really much needed, absolutely. I guess, in addition to what's already been asked, Mitch, can you help us understand what the kind of revenue stream would look like? I think, at the beginning of the call, you mentioned that you're in negotiations with BARDA around a supply agreement. Would that be the primary avenue for revenues, or would there be opportunities to negotiate directly with hospitals and providers? Just a little more understanding on what that opportunity would look like would be helpful. Thank you.
Yeah. The way to think of it is, you know, the government pre-orders and but that's not that. That's just scratching the surface. You know, the revenue stream will be coming directly from hospitals and ICUs across the country and across the world. When you think of the government, the way I would think of governments right now is two things. One is they're gonna prime the pump, and so maybe $2.5 billion or more, because, you know, you're dealing with different pharmacoeconomics here. This is not, you know, treating somebody who's got some symptoms of COVID-19 and treating thousands of patients to go from 14% to 7% reduction in deaths and hospitalizations.
This is reduction of deaths in patients in the ICUs and in hospitals that are requiring tremendous resources to keep them alive, and unfortunately, half of them will go on to die anyway. That's what's overwhelming the system, and that's what's costing the most money, and that's where we're going. If we can reduce that by 55%, then you can see that the revenue should be significant and, you know, $2.5 billion, you're really just scratching the surface in terms of that.
Now, with that said, the expectation is that governments will, in addition to priming the pump, so to speak, to get into hospitals and to start dealing with the pandemic, the most important part, which is the part that's missing, which is to save people from dying, is that have already you know gone down that path of slippery slope, is stockpiling. Our expectation is that you know we don't wanna be caught when COVID -23 and COVID -24 and COVID -25 come along. We know there are at least two additional strains that are brewing out there right now that we're trying to understand. We're still trying to get our arms around BA.2. I heard this morning, 29 states have already reported an increase in COVID-19, so it's coming back, another surge.
With that said, stockpiling so that they're ready for the, you know, the next epidemic is probably gonna be another piece of the revenue that, you know, we can count on for our company. This is just, you know, as I mentioned in my opening comments, this is the singularly biggest threat to the world right now. We've come up with an agent that's an antiviral, anti-inflammatory that deals with patients that have a viral issue and the concomitant triggered inflammatory issue that leads to their demise.
Yeah, absolutely. I think to that point, Mitch, maybe just to put a bow on that, what level of long-term stability do you have on sabizabulin right now? I know you said you want me to hop back in the queue, but I'll just ask it anyway, which is, does this change any of your plans in terms of sabizabulin development in oncology? I'm just trying to think if there's any sequelae for pricing or exposure, anything else that we should consider down the line. Thank you.
Yeah, good question. Where we are with stability right now is we're at 12 months. I think that'll get you a two-year expiry or something like that. Usually, that's typically what you have to provide. We'll be good with that. I can tell you the stability of sabizabulin is such that, you know, we'd be very surprised ultimately we can't get five years. Right now, I would think the launch with it, of the product would be around two. As it relates to your question about affecting the other programs, you know, fortunately, we have a really you know we've done a great job pulling together a great team to stay on top of the clinical trials in oncology. As you know, we have robust prostate cancer and robust breast cancer programs.
Those are gonna continue as planned. We're not expecting any changes there. There's no question that this is a big, monumental next step for our company. Again, as I said in my comments, we're up for the task. We will do what we need to do. We are very fortunate that we're still incredibly well capitalized. As I mentioned in previous calls, that last call, the last public information from our last quarter ending, the money on hand is about $116 million in the bank, and we've got, you know, a product and soon products that are generating revenue. We're fine.
A lot of what we're gonna be doing right now is the resources are gonna be regulatory resources and, you know, manufacturing resources, and you know, that's not expensive. We're not running clinical trials for, you know, additional clinical trials, you know, large clinical trials in cancer, I think we're set. All that's in the budget. With that said, I think we're in good shape. The impact is, yes, we're gonna be highly focused in getting sabizabulin to market, but we're not gonna take our eye off the ball on the oncology products that are in late-stage clinical development.
Okay. That's very clear, and I appreciate your time, and congratulations again.
Thank you, Chris.
Our next question comes from Kumar Raja from Brookline Capital Markets. Please go ahead.
Thanks for taking my questions, and also congratulations on the data. With regard to the age of the patients, what can you share, in regards to patients who are 65 and older? With regard to the stratification data, on Delta with Omicron, and age and country, when do you think that would be available?
I said I'm gonna ask Dr. K. Gary Barnette to answer that question.
Yeah. We just have some analyses. We haven't obviously gotten all the data yet. However, the age is equally distributed across the two treatment groups. The mean and standard deviation are identical. The average age in the study was in the low sixties. As far as stratification, we have equal balance of all the WHO scores, four, five, six, et cetera. We also have an equal balance, as Mitch mentioned, in standard of care across the treatment groups. As far as Omicron and Delta and what variant, we know that patients in both groups in the study had Omicron and Delta.
We have not, we've not done any analysis on how those two broke out between the two treatment groups. However, in this type of study, you would expect it to be fairly similar between the treatment groups.
Right. As I mentioned in my comment, no imbalances. Also, the p -value that we announced in the interim takes into account all of the information you just asked about.
That's right.
That's great. And also, what are your thoughts on, you know, potentially exploring the drug in early infections so as to prevent hospitalization? Are you guys thinking about it, or you think this should be good enough?
Just make sure I understand the question. You're using it in other patient populations?
Earlier.
Earlier. Yes. I'm gonna answer it two ways. The first thing is we've got a plateful getting this thing out in the area that has the greatest need, which is, you know, patients that are dying in the hospital. That's the part that scares everybody 'cause that's gonna lag the incidences. You know, the incidence goes up, and then you get your hospitalizations, then you get your deaths, and it just keeps happening. When you look at the number of deaths, you know, approaching 500,000 and 600,000 in the U.S., it scares you, okay? 'Cause, you know, that's unbelievable.
We're sitting around saying, "Well, maybe we should just drop our masks because that's okay." Anyway, I would say to you that if we can get into the hospitalized space, moderate, severe COVID-19, we'd make a major change in the battle that's ahead of us. Now, with that said, you know, the science, the mechanism of the drug is that it's both an antiviral and anti-inflammatory agent, and it, you know, it's, you know, we're using it in cancer patients at very high doses, and I can tell you that the safety looks very good. In this patient population, you'll see the safety data eventually, and I think you're gonna be incredibly surprised how well it's tolerated.
With that said, because it's so well tolerated, you can go earlier and, you know, and could this be a standard of care for, you know, prevention or something of that nature when somebody thinks they've been exposed? You're not having to take 40 pills with, you know, P-glycoprotein inhibitors like ritonavir and all that stuff. One pill a day or even maybe a lower dose is possible. But again, our focus is, you know, our primary focus is to get this indication across the finish line.
Great. Thanks so much.
Thank you.
Our next question comes from Roni Rabin from The New York Times. Please go ahead.
Hi. Thank you. Some of my questions were answered, just to clarify, these results are from a randomized double-blinded placebo-controlled trial. If you could say anything more about the mechanism of the drug, how it works.
Sure. Happy to. Thank you for calling in. The mechanism of the drug is that it is a small molecule that binds to microtubules. Microtubules are a structure in cells that are responsible for transporting whether they're viruses or receptors in the cell. A cell's not like a bag of soup with things just floating around where it wants to go. It's highly structured. The network, the trafficking that occurs in the cell and the highways that cause that trafficking to occur is the microtubules. When a virus infects a cell, it binds to the microtubule, and it's actually brought on that railroad track, if you wanna call it that, into the nucleus, where it divides into more viruses. Then the viruses can't just float out.
They have to get back on that track and get and make their way back to the outside of the cell, where it gets liberated to infect additional cells. The reason why we're not variant dependent is because that's such a critical process for a virus to get into a cell, get replicated, and go back out, that if they had a mutation that wouldn't let them stick onto the highway, they couldn't infect. Whether you know whether you have a blue bus, a red bus, your car, if you use the highway, you're gonna be affected. We see that. I mean, Omicron or the Delta variant, it just doesn't matter. That's why we, you know, we feel that we have almost like a broad-spectrum antibiotic concept.
It's a broad-spectrum antiviral 'cause it's just not so specific like an antibody where, you know, as soon as the virus mutates, the antibody doesn't work. This is pretty broad. The mechanism is it disrupts these highways and breaks them down so that the virus can't get from point A to point B. That same mechanism is how the cell causes the cytokine storm. The cytokine storm is, you know, a bunch of bags filled with inflammatory proteins that the cell has to push outside the cell. The way it does that is it puts these, you know, these vacuoles onto the highway, the microtubules, and releases them into the outside the cell to, you know, to create inflammation.
What our compound does by disrupting the microtubules, it also makes it such that the cytokines can't get liberated. That's why it's an anti-inflammatory antiviral. Same mechanism. Disrupts the microtubules, the highway, so things can't get in, things can't get out.
To follow up your first question, yes, this was a double-blind placebo-controlled study, conducted in accordance with current GCPs.
Thank you so much. Great explanation. Thanks.
The next question comes from Max Bayer from Fierce Biotech. Please go ahead.
Hey, good morning, all. Thank you for taking my question. You mentioned that some of this interim analysis covers both the Delta and Omicron periods. I'm wondering if you have any top-line efficacy differences based off of those variants. I was also wondering if, among the patient population, you had any data on the percent or the number of patients that were immunocompromised, and if there are any differences among those patients. Thank you.
Okay. Gary?
Yeah, this is Gary. We don't have the data right now, top-line data on anything related to the proportion of or what happened in the various variants. We just don't have that yet. We will analyze that as we go forward. As far as that is part of the analysis of the data that would be going forward. Right now, we know that Omicron and Delta both were included in the study.
Well, as it relates to immunocompromised patients, again, we're not seeing any groups of patients that are imbalanced between the treated and the untreated. We're not seeing that, not seeing males, females. It all is very, very balanced. The randomization process looked like it went well. All of those potential differences were, you know, accounted for and looked at in the top-line data. We feel pretty good. The independent data monitoring committee also, you know, voted unanimously that after they reviewed the data that, you know, moving forward, it's just unethical.
I mean, we saw, you know, overwhelming efficacy, so they stopped the study and they looked at that same kinds of data that you're mentioning now.
Thank you.
Thank you.
Ladies and gentlemen, this concludes our question-and-answer session. I would like to turn the conference call back over to Dr. Mitchell Steiner for any closing remarks.
Thank you. I appreciate all of you joining us on today's call. I look forward to updating you on all our progress. I will tell you that COVID-19 remains the biggest single threat to the world right now across the board. We're two years into the pandemic. Sabizabulin has emerged as a drug that can go right in, right into the hospitalized world, where patients are dying and make a difference. It's a new chemical entity. It's not a repurposed drug. We're looking forward to moving that across the finish line. This positive phase III data is a transforming event for Veru in our fight against the COVID-19 pandemic. Thank you for joining us today.
The digital replay of the conference call will be available beginning approximately noon Eastern Time today, April eleventh, by dialing 1-877-344-7529 in the U.S. and 1-412-317-0088 internationally. You will be prompted to enter the replay access code, which will be 582-0166. Please record your name and company when joining. The conference call has now concluded. Thank you for attending today's discussion.