Brian Ritchie; Managing Director, LifeSci Advisors, LLC; Relmada Therapeutics Inc
Sergio Traversa; Chief Executive Officer, Director; Relmada Therapeutics Inc
Maged Shenouda; Chief Financial Officer; Relmada Therapeutics Inc
Uy Ear; Analyst; Mizuho Securities USA
Basma Radwan; Analyst; Leerink Partners
Andrew Tsai; Analyst; Jefferies
Operator
Greetings and welcome to the Relmada Therapeutics Incorporated quarter four 2024 financial results call.
(Operator Instructions)
It is now my pleasure to introduce Brian Ritchie.
Thank you. Brian, you may be good.
Brian Ritchie
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 year 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, 2024, 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 our Relmada's CEO, Dr. Sergio Traversa, who will briefly provide a summary of recent business highlights; and Relmada 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?
Sergio Traversa
Thank you, Brian, and good afternoon and welcome everyone to the Relmada fourth quarter and year-end 2024 conference hall.
Well, Relmada is focused on three priorities, progressing our product pipeline including NDB01 and Sopranoon. And exploring product acquisition opportunities to maximize shareholder value. And three, maintaining careful resource 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 are 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.
Establish 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 around 1,017 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 indepth reviews of several compelling candidates, we recently announced the acquisition of rights to two candidates, NDVA1 in development for non-muscle invasive bladder cancer, and ranol 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 NDVO1 and Soprano and also provide an update on our plan for well P 11.
Let's start with NDDO1. On March 25, we announced an exclusive licensing agreement with Trigon Parma Limited for NDBO1, a novel sustain relief, intravesical chemotherapy for the treatment of high grade non-muscle invasive bladder cancer, NMIBC and potentially other subtype of bladder cancer.
The program is currently in a Phase 2 study. We believe that NDO1 is an excellent fit with our 4 key target criteria. Number one, innovation. Trigon intravesical sustained release formulation of genocide in endoscetaxel could represent the true innovation in the care of high grade non-muscle invasive bladder cancer.
Number two, proof of constant data. Prost, studies support the efficacy of genocitabine endocetaxel dosing in the treatment of NMIBC. Number three, near term value drivers. We expect the top line safety and efficacy data for NDVO1.
To be reported at the American Neurological Association meeting, AUA, it will be held on April 26 to 29, 2025 in Las Vegas. And number four, the potential to address well-defined and deserved markets. Sources indicate that there are about 75,000 new cases of bladder cancer diagnosed.
About 50 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 they are living with bladder cancer. NDVO1 is currently evaluated in a Phase 2 single armed 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 subjects with localized, non-metastatic, high grade, non-muscle muscle invasive bladder cancer. Top line data from the first approximately 20 patients in the study are expected to be presented at the American Neurological Association meeting in Las Vegas on April 26 to April 29 this year.
Our goal is to bring NDVO1 to patients as soon as possible. With positive results, we believe that NDVO one could become the treatment of choice for high grade non-muscle invasive bladder cancer. Both as first line therapy for new patients and salva 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 calmetarin BCG causes the cornerstone of treatment.
However, significant supply constraint prompted the evaluation of intravesical chemotherapy.
The medical evaluated a number of chemotherapy agents and published studies suggested that the use of intravesical citabine and docetaxel, known as gemsy, is to be the preferred combination with improved response rates and promising tolerability.
Still, frequentgenos 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 NDVO1.
And the one is administered in a simple two-step process in the urologist's 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 to employ.
NVA1 forms a spherical soft matrix within the bladder that sequester drugs and releases it is in a matrix gradually dissolved over 10-day period. MDVO one formulation is specifically designed to maximize local drug concentration and prolonged exposure to geosy while minimizing systemic toxicity.
Unlike a conventional intravertical installation, NDO1 is designed to avoid peaks and toughs in drug concentration, ensuring a gradual and sustained release of genosic 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 NDVO1 has the potential to improve on the published geosy results with less frequent dossing, e of administration, and improved treatment compliance, which could lead to improved clinical outcome in high grade non-muscle invasive bladder cancer.
Our positive per perspective is supported by primary field research with their care providers. The next step includes to present the 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 sopranolol. On February 6, we acquired sopranolon as a potential therapy for Tourette syndrome and other compulsion-related conditions from Azarina. We believe that is an excellent fit with our key criteria. Number one, innovation.pranolol is a compound from a new subgroup of neuros known as gas or gaba modulating steroid antagonists.
GAAA act selectively on the gaba-A pathway to alleviate the symptoms or compulsive disorder. Number two, proof of constant data. Phase 2A results from Mazarina signal improvement in Tourette syndrome, quality of life, and over robust overall safety.
These data support cepranolol as a new potential first line treatment option for Tourette's syndrome and open the door to evaluation in other compulsion-related disorder. Number three, near term value drivers, with promising Phase 2A data and safety information from more than 350 subjects. The final one is a Phase 2 be ready.
Number four, the potential to address well-defined and deserved market. Tourette syndrome impact more than 350,000 children in the US. No sorry, no children, impact more than 350,000 patients in the US after RED syndrome.
Existing treatment includes dopamine, B blockers, an at typical antipsychotics are often limited by significant side effects.
Stepping back for a moment ran is a neurosteroid and the first in class or gaba modulating steroid antagonists by selectively inhibiting gaba neurotransmitter includedopan, a neurosteroid implicated in Tourette syndrome and other compulsive disorders.
Our evaluation of soprano 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.
The estimated global prevalence is approximately 350 to 400,000, and current treatment is focused on improving obsessive compulsive behavior and other medical conditions.
The Pradool 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 an existing comprehensive treatment regimen for Prader releases.
Next step into a meeting with the SDA to align on the regulatory path to approval, further development of the product supply plans, and finalizing the design of the 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?
Maged Shenouda
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 RP11 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 pre-clinical 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 LP11 is well tolerated.
However, we are re-evaluating further development of PL1 given. Our emphasis on focused patient populations and the increasingly competitive clinical development landscape and 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 re-evaluating our resources for PL11 as we devote a substantial portion of our internal resources to the development of NDVA1 and Soprano.
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 end, and the 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 website, and the news and SEC filings tabs are on our investor relations page.
As of December 31, 2024, Relmada had cash equivalents, and short-term investments of approximately $44.9 million compared to $96.3 million as of December 31, 2023. Cash uses and operations in the fourth quarter ended December 3,031, 2024 was approximately $8.8 million compared to $10.2 million for this same period in 2023.
Looking ahead, we expect to devote substantial a substantial portion of our internal, excuse me, of our internal resources to the development of NDVO1 and soprano soprano.
We will have a greater sense of our spending cash runway following the planned FDA interactions intended to be completed later this year.
Moving through our fourth quarter of 2024 financial results. Research and development expense for the fourth quarter of 2024 totaled $11 million compared to $14.7 million for the fourth quarter of 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 1,017 for major depressive disorder.
General and administrative administrative expense for the fourth quarter of 2024 totaled $8.1 million compared to $12.1 million for the fourth quarter of 2023, 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?
Sergio Traversa
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 a product pipeline and maintaining careful resource allocations. Our evaluation of strategic product opportunities is focused on key target criteria.
Innovation. Proof of comes to data. Near term value creation drivers and potential to address underserved markets with flexibility to be opportunistic, even our drug development expertise.
Our plans for each program center 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 become the game around the year end this year or early 2026.
For NDVO1 in development for high grade non-muscle invasive bladder cancer, we expect initial prooval concept data. To be reported that the American Neurological Association meeting AUA held in April 26, 29, 2025 in Las Vegas.
Our next study is expected to be a registration of trial. For sopranolon, our next study is expected to be a signal finding study in Prader-Willi syndrome, and the Phase to be study intoure syndrome.
In closing, as we prepare to advance our two clinical programs, we want to thank our investors 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.
Operator
(Operator Instructions)
Uy Ear, Mizuho Securities.
Uy Ear
First, congratulations on the two deals. Yeah, may, 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 NDV01.
And why these companies chose to go with you if there are other bidders over the other bidders, 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 the sort of the key data will will be at the conference?
Sergio Traversa
Well, thank you, Ear. Thanks for the question. I'll start with the first one. Why, partners decided to come with Relmada instead of other companies? Well, the first acquisition of Soprano loan 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. Plan in advance regardless of what the outcome of the 17 would have been.
So that was, it's been a long time in our other suite we've been talking with that Serena, so that was a little bit more simple. NDBO one, it was a lot more competitive and and the reasons, well, we should ask to try on the real reason or the specific reason they decide 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, 4 Phase 3 trials, probably 10 Phase one, additional Phase 2 abuse deterrent study.
So we do have quite a bit of expertise that can be applied. To other therapeutic categories and that's clearly has a value. The infrastructure is intact and so that it was clearly one component. The other components are a little bit like softer and more customized to the relation we have with Trigon. It also has been a long term. A relation.
NDVO1 is one of the two products that Remada has now, so clearly we put a lot of focus on these two products. So there is no risk that NDVO 1 will be one of the 1,020 projects in development that larger companies they have.
So focus on the program that's clearly what one of the reasons and then the second. One is that you know when we do this kind of transactions for both companies, Azarina and Trigon, we work together. So both management of Azarina and Trigon, they were very close with this real partnership.
And we don't want to lose the know-how with the expertise of people that have been working on these plans on this program for years and years. So I mean being part of the 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 Remada the company of choice at least for -- yes, you can.
Maged Shenouda
Can I add one thing? The other, I think, important factor is now Trigon or Trigon shareholders are also shareholders of Realmada and will participate significantly in the upside related to NDVO1.
Sergio Traversa
Thank you, Maged.
I hope we answer like the your answer the first question we and the second one I yeah, 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 would 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 patients are still in treatment and they're still being evaluated.
And in terms of expectations, look, it is a very competitive market. There is several products in development for the treatment of bladder cancer. The, we do have the data. Published available on the combination genozi, 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 like when you have a complete response of month 3 or 4, 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 the, from neurologist. We'll see what NDVO1 will will deliver.
Uy Ear
So is our is the expected data is that primarily from the 3 months of induction and any particular. Yeah maybe.
Maged Shenouda
Maybe I can step maybe I maybe I can step in here we really, we want to be respectful of the meeting we want to re be respectful of, whatever restrictions there are about data release so you know just to be mindful of that we'd rather not, delve into the expected data release.
We'll get to learn a lot more, when the abstracts are presented and then when the data are released, so.
Operator
Marc Goodman, Leerink Partners.
Basma Radwan
This is Basma on for Marc.
Our first question, could you please elaborate a little bit on the safety profile of soprano loan? And also the, we have a question on the second indication, which is better reallyli. Now, given that the space is a little bit crowded after the recent approval, of the first agent in this, indication, do you think, That's, it's going to be a valuable second opportunity for the drug.
Sergio Traversa
Well, thanks for the questions. The safety profile of soprano on it, 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're still talking about low single digit was, is a subQ injection, so was the injection site, redness and some irritation.
Temporary, so that was it. So that can be read as an extremely well tolerated drug.
And on the second question, the product really, 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 drugs for the treatment of this pre terrible syndrome or bad syndrome of this, the product really.
In terms of the space for soprano acts on the gaba A and it acts on the compository 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 mechans of action. There is some complementarity between soprano and what is available and what what potentially will become available.
I hope I answer your question.
Operator
(Operator Instructions)
Andrew Tsai, Jefferies.
Andrew Tsai
Congrats on in licensing these compounds pretty cool, maybe for soprano loan, 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?
Sergio Traversa
Well, thanks, thank you. Great hearing from you and thanks for the question. So the Let me be sure that I understand what the endpoints are. What will be for Prather really, the end points, the FDA knows the path very well and and so the you have seen the approval yesterday.
So we do believe that that is pretty much the endpoint that would define the process of the regulatory process, and we haven't spoken with the FDA yet, so it's, I'm 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 end points there is a scale, the scale, this is the usual end points and measure like the number of ticks.
And based on the mechanism of action, we'll try to incorporate in the endpoints also the compulsive aspect of the Tourette's syndrome, and you may know that about 40% of patients with They also are affected by obsessive compulsive components. So, the, 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.
Andrew Tsai
And then for the bladder cancer compound, after you 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?
Sergio Traversa
Well, not right after the data, but probably after we dis we 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 they've been approved. And also considering that genozi, the combination of gencitabine 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 at 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 NDBO one.
It's a little bit too early to make like big statements.
Andrew Tsai
And then my last question is can we expect you to license more compounds this year?
Sergio Traversa
Well, we always keep our eyes open. We have done a lot of evaluations. There is a lot of product available for foreign licensing the great ideas. And there are small companies, private, they have like issues in like the capability of developing or doing Phase 2 and the avail of, financing and as a public company with the right development capability, I would say that you know other other potential license or 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 the our goal is to, build the pipeline and they already we have two products now and to 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, in the future, you never know. We keep on keep an eye on everything. But we will only do, we are selective, right? We don't want to license something just to license something. We want to have something that has potentially defeat our development criteria that, we discussed during the call.
Operator
And with that, there are no further questions at this time. I'd like to turn the floor back to Sergio Traversa for closing my remarks.
Sergio Traversa
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 investors.
Thank you very much.
Operator
Thank you.
And with that does conclude today's teleconference. We thank you for your participation. You may disconnect your lines at this time.
