RLMD - NASDAQ

Greetings, and welcome to the Relmada Therapeutics, Incorporated Quarter 4 2024 Financial Results Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation [Operator Instructions]. As a reminder, this conference is being recorded. It is now my pleasure to introduce Brian Ritchie. Thank you, Brian. You may begin.

Good day, everyone. And thank you for joining us today. This afternoon Relmada issued a press release providing a business update and outlining its financial results for the three months and year ended December 31, 2024. Please note that certain information discussed on the call today is covered under the safe harbor provision of the Private Securities Litigation Reform Act. We caution listeners that during this call, Relmada's management team will be making forward-looking statements. Actual results could differ materially from those stated or implied by these forward looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are qualified by the cautionary statements contained in Relmada's press release issued today and the company's SEC filings, including in the annual report on Form 10-K for the year ended December 31, 2024, filed after the close today. This conference call also contains time sensitive information that is accurate only as of the date of this live broadcast, March 27, 2025. Relmada undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call. With me on today's call are Relmada's CEO, Dr. Sergio Traversa, who will briefly provide a summary of recent business highlights and Relmada's CFO, Maged Shenouda, who will provide a review of the company's Q4 financial results. After that, we will open the line for a brief Q&A session. Now, I will hand the call over to Sergio Traversa. Sergio?

Thank you, Brian. And good afternoon, and welcome everyone to the Relmada fourth quarter and year end 2024 conference call. Relmada is focused on three priorities, progressing our product pipeline, including NDV-01 and Sepranolone and exploring product acquisition opportunities to maximize shareholder value. And third, maintaining careful resource priorities -- prioritization. During today's call, I will spend a moment on our strategic product acquisition efforts and provide a pipeline update. After that, Maged will review our financial results. I will make a few closing remarks and then we will take your questions. At the end of last year, we initiated a process to transform the company through strategic product acquisition efforts to maximize shareholder value. I am pleased to report that the process is going well. We have always maintained an active surveillance to consider programs that have the potential to be high value assets and meet our key target criteria of innovation, established proof of concept points, near term value creation drivers and the potential address well defined underserved markets. With the discontinuation of the Phase 3 studies of REL-1017 in major depression disorder, we made the exploration of strategic product acquisition our primary focus. We have been following the progress of several programs and our recent efforts identified an additional number of attractive opportunities. After in depth reviews of several compelling candidates, we recently announced the acquisition of [indiscernible] to two product candidates, NDV-01 in development for non-muscle invasive bladder cancer and sepranolol for compulsion related disorders. While we maintain a deep understanding of diseases of the central nervous system as we evaluate strategic opportunities, the drug development expertise of our team provides flexibility to be opportunistic and consider innovative programs that meet our target criteria regardless of the therapeutic area. Moving on to our product pipeline, I would like to provide a brief overview for NDV-01 and Sepranolone and also provide an update on our plan for REL-P11. Let's start with NDV-01. On March 25th, we announced an exclusive licensing agreement with Trigone Pharma Limited for NDV-01, a novel sustained release intravascular chemotherapy for the treatment of high grade non-muscle invasive bladder cancer, NMIBC and potentially other subtype of bladder cancers. The program is currently in a Phase 2 study. We believe that NDV-01 is an excellent fit with our four key target criteria. Number one, innovation. Trigone intravesical sustained release formulation of gemcitabine and docetaxel could represent the true innovation in the care of high grade non-muscle invasive bladder cancer. Number two, proof of concept data. Previous studies support the efficacy of gemcitabine and docetaxel dosing in the treatment of NMIBC. Number three, near term value drivers. We expect the top line safety and efficacy data for NDV-01 to be reported at the American Urological Association Meeting, AUA, that will be held on April 26 to 29, 2025 in Las Vegas. And number four, the potential to address well defined underserved markets. Sources indicate that there are about 75,000 new cases of bladder cancers diagnosed. About fifty of those cases have high grade disease that has a high risk of recurrence. There is a very high recurrence rate for the 450,000 people in the US that are living with bladder cancer. NDV-01 is currently evaluated in a Phase 2 single arm study to assess safety and efficacy in patients with high grade non-muscle invasive bladder cancer. The study was designed to evaluate safety and efficacy subject with localized non-metastatic high grade non-muscle invasive bladder cancer. Top line data from the first approximately 20 patients in the study are expected to be presented at the American Urological Association Meeting in Las Vegas on April 26 to April 29 this year. Our goal is to bring NDV-01 to patients as soon as possible. With positive results, we believe that NDV-01 could become the treatment of choice for high grade non-muscle invasive bladder cancer, both as first line therapy for new patients and salvage therapy for existing patients whose disease has progressed. Let's spend a moment on the treatment of high grade non-muscle invasive bladder cancer. Intravesical therapy is a mainstay of treatment intended to reduce the risk of recurrence following surgery. Previously, the immunotherapy, Bacillus Calmette-Guerin, BCG, was the cornerstone of treatment. However, significant supply constraint prompted the evaluation of intravesical chemotherapy. The medical community evaluated a number of chemotherapy agents and published study suggested that the use of intravesical gemcitabine and docetaxel known as GEMDOCE is to be the preferred combination with improved response rate and promising tolerability. Still, frequent GEMDOCE dosing is required and the chemotherapy agents have a short bladder retention time, which limits the exposure to the chemotherapy. Together, this factor increased the risk of treatment failure and discontinuation and prompted the development of NDV-01. NDV-01 is administered in a simple two step process in the urologist office. It is designed for intravesical dosing and intended to be an in office ready to use therapy that is administered rapidly within 10 minutes and requires no anesthesia or new or dedicated equipment to employ. NDV-01 forms a spherical soft matrix within the bladder that sequester drugs and releases it as a matrix gradually dissolve over 10 days period. NDV-01 formulation is specifically designed to maximize local drug concentration and prolong exposure to GEMDOCE while minimizing systemic toxicity. Unlike the conventional intravesical installation, NDV-01 is designed to avoid peaks and tops in drug concentration, ensuring a greater gradual and sustained release of GEMDOCE over a 10 day period. This approach may improve overall efficacy, reduce side effects and reduce the frequency of dosing to improve patient compliance and outcomes. We believe that NDV-01 has the potential to improve on the published GEMDOCE results with less frequent dosing, easy of administration and improved treatment compliance, which could lead to improved clinical outcome in high grade non-muscle invasive bladder cancer. Our positive perspective is supported by primary field research with our care providers. The next step include to present top line Phase 2 results in four weeks, meeting with the FDA to align on a regulatory path to approval, completing the production of the next batch of material and finalizing the design of registration study intended to begin in late 2025 or early 2026. Moving on to Sepranolone. On February 6th, we acquired Sepranolone as a potential therapy for Tourette syndrome and other compulsion related condition from Asarina Pharma. We believe that Sepranolone is also an excellent fit with our four key target criteria. Number one, innovation. Sepranolone or Isoallopregnanolone is a first class compound from a new subgroup of neurosteroids known as GAMSAs or GABA-A modulating steroid antagonist. GAMSAs act selectively on the GABA-A pathway to alleviate the symptoms for compulsive disorder. Number two, proof of constant data. Phase 2a results from Asarina signal improvement in Tourette's syndrome, quality of life and robust overall safety. These data supports Sepranolone as a new potential first line treatment option for Tourette syndrome and open the door to evaluation in other compulsion related disorder. Number three, near term value drivers. With promising Phase 2a data and safe information from more than 350 subjects, Sepranolone is a Phase 2b ready program. Number four, the potential to address well defined underserved markets. Tourette's syndrome impact more than 350,000 children in the US -- impact more than 350,000 patients in the US have Tourette syndrome. Existing treatment include dopamine B2 blockers as typical antipsychotics are often limited by significant side effects. Stepping back for a moment, Sepranolone is a neurosteroid and the first in class GAMSA or GABA-A modulating steroid antagonist that acts by selectively inhibiting GABA neurotransmitter included allopregnanolone, a neurosteroid implicated in Tourette syndrome and other compulsive disorder. Our evaluation of Sepranolone has also included a review of other prominent compulsion related disorder and we identified Prader-Willi syndrome or PWS as another potential indication as it is often defined by persistent hunger and overeating apophagia that may have a strong compulsion related element. The estimated global prevalence is approximately 350,000 to 400,000 and current treatment is focused on improving obsessive compulsive behavior and other medical condition. Sepranolone might be ideally suited for Prader-Willi syndrome given its good overall tolerability and unique impact on compulsivity disorder, which could enable it to be incorporated into existing comprehensive treatment regimen for Prader-Willi syndrome. Next step include meeting with the FDA to align on the regulatory path to approval, further development of the product supply plans and finalizing the design of a Phase 2b study intended to begin late 2025 or early 2026. Now I would like to turn the call over to our CFO, Maged Shenouda to talk about our portfolio prioritization efforts and financial results. Maged?

Thank you, Sergio. Portfolio prioritization and resource alignment are important elements for our strategic value creation process. As part of our prioritization, I want to provide an update on REL-P11 or P11, a novel low dose modified release formulation of psilocybin in development for the treatment of metabolic disorders such as obesity. We advanced P11 into a first in human study in Canada based on promising preclinical data showing that P11 improved metabolic parameters in animal models with no detrimental psychedelic like side effects at doses tested. Results of the Phase 1 study indicate that REL-P11 is well tolerated. However, we are reevaluating further development of P11 given our emphasis on focused patient populations and the increasingly competitive clinical development landscape in metabolic disease. While there has been a significant resurgence of effort to bring psychedelics into approved clinical use, we also recognize caution among regulators and clinicians that may complicate development. As a result of these factors, we are reevaluating our resources for P11 as we devote substantial portion of our internal resources to the development of NDV-01 and Sepranolone. Turning to our financial results. As noted by Brian, this afternoon, we issued a press release announcing our business and financial results for the fourth quarter and year ended December 31, 2024. Full details are available in our press release and the 10-K filing we completed today. These documents are available on our Web site and the news and SEC filings tabs are on our Investor Relations page. As of December 31, 2024, Relmada had cash, cash equivalents and short term investments for approximately $44.9 million compared to $96.3 million as of December 31, 2023. Cash used in operations in the fourth quarter ended December 31, 2024 was approximately $8.8 million compared to $10.2 million for this same period in 2023. Looking ahead, we expect to devote a substantial portion of our internal resources to the development of NDV- 01 and Sepranolone. We will have a greater sense for our spend and cash runway following the planned FDA interactions intended to be completed later this year. Moving through our fourth quarter 2024 financial results. Research and development expense for the fourth quarter 2024 totaled $11 million compared to $14.7 million for the fourth quarter 2023, a decrease of $3.7 million. The decrease was primarily driven by a decrease in study costs associated with the completion of clinical trials for REL-1017 for major depressive disorder. General and administrative expense for the fourth quarter of 2024 totaled $8.1 million compared to $12.1 million for the fourth quarter of 2023, a decrease of approximately $4 million. The decrease was primarily driven by a decrease in stock based compensation expense. Net cash used in operating activities for the fourth quarter of 2024 totaled $8.8 million compared to $10.2 million for the fourth quarter of 2023. The net loss for the fourth quarter of 2024 was $18.6 million or $0.62 per basic and diluted share compared with a net loss of $25.1 million or $0.84 per basic and diluted share for the fourth quarter of 2023. Before we open the call for questions, I'll turn the call back to Sergio for some closing comments. Sergio?

Thank you, Maged. I would like to leave you with these key messages from today's call. Relmada is focused on three priorities, exploring strategic product acquisition to maximize shareholder value, progressing of our product pipeline and maintaining careful resource allocation. Our evaluation of strategic product opportunities is focused on key target criteria, innovation, proof of constant data, near term value creation drivers and potential to address underserved markets with flexibility to be opportunistic given our drug development expertise. Our plans for this program is centered around interacting with the FDA to align on regulatory strategy, complete production of the next batches of material and finalize the design of the next studies expected to begin around year end this year or early 2026. For NDV-01 in development for high grade non-muscle invasive bladder cancer, we expect initial proof of concept data to be reported at the American Urological Association Meeting AUA held in April 26, 2025 in Las Vegas. Our next study is expected to be a registrational trial. For Sepranolone, our next study is expected to be a signal finding study in Prader-Willi syndrome and the Phase 2b study in Tourette syndrome. In closing, as we prepare to advance our two clinical programs, we want to thank our investor for support and for taking time to join today's call. We look forward to updating you on our progress throughout the year. Operator, I would like now to open the call for questions. Thank you.

[Operator Instructions] And our first question comes from Uy Ear with Mizuho Securities.

A question that we've been getting is maybe just help us understand the process that was involved in the deal, why the -- were there other competitive bidders for particularly for NDV-01 and why these companies chose to go with you if there are other bidders over the other bidders? That's first question. And I guess the second question we have is, at the upcoming AUA meeting, what should we kind of expect in terms of potential data? And I think the abstract will be out on April 11 or something. Will there be data in the abstract or sort of the key data will be at the conference?

I'll start with the first one, why partners decided to come with Relmada instead of other companies. The first acquisition of Sepranolone was a little bit more simple and was a straight acquisition of an asset that we knew we have known for a long time. And to be very direct, that acquisition was planned in advance regardless of what the outcome of the REL-1017 would have been. So that was -- it's been a long time in our rather [indiscernible] we've been talking with Asarina. So that was a little bit more simple. NDV-01, it was a lot more competitive and the reasons -- well, we should ask Trigone the real reason or what the reason -- specific reason he decided to come with us. But our impression what we can offer and we can put on the table is clearly a strong development capability. And we have done four Phase 3 trials, probably 10 Phase 1, additional Phase 2 abuse deterrent studies. So we do have quite a bit of expertise that can be applied to other therapeutic categories and that clearly has a value. The infrastructure is intact. And so that was clearly one component. The other components are a little bit like softer and more customized to the relation we have with Trigone. It also has been a long term relation. NDV-01 is one of the two products that Relmada has now. So clearly, we put a lot of focus on these two products. So there is no risk that NDV-01 will be one of the 10, 20 project development that larger companies they have. So focus on the program that's clearly one of the reasons. And the second one is that when we do this kind of transaction for both companies, Asarina and Trigone, we work together. So both management of Asarina and Trigone, they were very close with us, it's really a partnership. And we don't want to lose the knowhows, the expertise of people that have been working on these plans and this program for years and years. So I mean, being part of the program, being part of the team, they will try to bring this product to the market together with the focus and the development capability made the Relmada the company of choice at least for Asarina and for [Multiple Speakers] yes, you can.

Can I add one thing? The other, I think, important factor is now Trigone or Trigone shareholders are also shareholders of Relmada and will participate significantly in the upside related to NDV-01.

I hope we answered like -- your answer, the first question. And the second one, I have to be a little bit more cautious because in the abstract, there's not going to be any particular data, reason being that the data will be collected in real time. And so they will be ready to be presented when they will be available, this is right before the AUA conference. So they won't be ready to be included in the abstract because the patient are still in treatment and they are still being evaluated. And in terms of expectations, look, it is a very competitive market. There is several product in development for the treatment of bladder cancer. We do have the data published available on the combination GEMDOCE used as a immediate release that has been used for years and extensively used by urologists. So that would be the starting point. We do expect the data to be at least as good as what is the media release formulation and -- as of today and the data are available and published in the literature. So you find different numbers. But like the kind of rule of thumb that we heard from urologists is that, right, when you have a complete response of month three or four somewhere in the range of 75%, you definitely are in the competition. And this is a good number, right? This is just based on historical and then from urologist. We'll see what NDV-01 will deliver.

So is the expected data, is that primarily from the three months of induction and any particular…

Maybe I can step in here. We really -- you know, we want to be respectful of the meeting, we want to be respectful of whatever restrictions there are about data release. So just to be mindful of that we'd rather not delve into the expected data release. We'll get -- we'll learn a lot more when the abstracts are presented and then when the data are released.

Few more week of patience wait.

And our next question comes from Marc Goodman with Leerink Partners.

This is [Bhavna] on for Marc. Our first question, could you please elaborate a little bit on the safety profile of Sepranolone? And also the -- we have the question on the second indication, which is Prader-Willi. Now given that this piece is a little bit crowded after the recent approval of the first agent in this indication, do you think that it's going to be a valuable second opportunity for the drug?

The safety profile of Sepranolone, we know it very well. It's very well known and there are safety data on over 350 patients. And the only side effect that was more frequent we are still talking about low single digit was is a sub-cu injection, so was injection site, redness and some irritation, temporarily. So that was it. So that can be read as a extremely well tolerated drug. And on the second question, the Prader-Willi. Well, the answer is yes. There is definitely space for other products and we are very happy about the approval that we have seen yesterday because it means that the FDA and the patients association and the outside world wants and needs new drug for the treatment of this pretty terrible syndrome or bad syndrome at least the Prader-Willi. In terms of the space for Sepranolone, Sepranolone acts on the GABA-A and it acts on the compulsatory component that is very different from what the other products are working on. So I would not only say that there is space I would say that there is some complementary, at least based on the mechanism of action, there is some complementarity between Sepranolone and what is available and what potentially will become available. I hope I answered your question.

[Operator Instructions] And our next question comes from Andrew Tsai with Jefferies.

Maybe for Sopranolone, what is the approvable endpoint for pivotal studies? And what did you see in the Phase 2a on that endpoint and how would that compare to the dopamine blockers and antipsychotics used for Tourette's?

So let me be sure that I understand the question, what the endpoints are. What will be for Prader-Willi, the endpoint, the FDA knows the path very well. And so you have seen the approval yesterday, so we do believe that, that is pretty much the endpoint that would define the process or the regulatory process. And we haven't spoken with the FDA yet so it's just -- trying to deduct to use the logic and to try to learn from what's happening out there. For the Tourette syndrome, usually, the endpoints, there is a scale, the Yale scale, that is the usual endpoints and measure like the number of tics. And based on the mechanism of action, we'll try to incorporate in the endpoints also the compulsive aspect of the Tourette syndrome. And you may know that about 40% of patients with Tourette, they also are affected by obsessive compulsive components. So we may probably have to use the scale but we may also try to focus on what the drug does best that is controlling compulsive behavior.

And then for the bladder cancer compound, after you report the data at the medical conference, does it make sense in your upcoming FDA meeting to discuss whether an accelerated approval pathway is possible?

Well, not right after the data but probably after we will discuss with the FDA what the path for approval is. And if you look at how other drugs have been developed or are in development and the drugs that have been approved and also considering that GEMDOCE, the combination of gemcitabine and docetaxel has been widely used over the last, I would say, 10 years by urologists, we have some hope -- we have a good hope and like the other companies that the FDA will require only one study open label with no placebo. That's what we have seen. But we'll be -- we'll talk with the FDA and then we will update you on what the regulatory process for NDV-01 is. It's a little bit too early to make like big statements.

And then my last question is, can we expect you to in license more compounds this year?

Well, we always keep our eyes open. We have done a lot of evaluation. There is a lot of product available for in licensing. There are great ideas. And there are small companies, private, they have issues in like capability of developing or doing Phase 2 and the availability of financing. And as a public company with development capability, I would say that other potential licensor, they come to us. And as of now, we don't know if we'll do anything anytime soon but we clearly keep our eyes open. And our goal is to build the pipeline and they were ready, we have two products now and two, right, try to bring in any assets, any development program that fit in our strategy. So I have to be vague, because, right, there is nothing that will happen like this week or next week, but in the future you never know. We keep an eye on everything. But we will only do -- we are selective, right, we don't want to in license something just to license something. We want to have something that has potential and exceeds our development criteria that we discussed during the call.

Thank you. And with that, there are no further questions at this time. I'd like to turn the floor back to Sergio Traversa for closing remarks.

Well, thank you very much. We can end the call. But I would like to end it with a big thank you for the support and for the people that have believed and believe in the company and in us that we can develop products and we can bring to the market help for patients and return for investment. Thank you very much.