Relmada Therapeutics at Small-Cap Virtual Conference: Strategic Insights on Cancer Treatment

On Thursday, 18 September 2025, Relmada Therapeutics (NASDAQ:RLMD) presented at the Small-Cap Virtual Conference, focusing on its novel treatment strategies for non-muscle invasive bladder cancer (NMIBC) and compulsivity disorders. The company’s management highlighted promising clinical data and financial stability, while acknowledging future financing needs. The discussion also addressed competitive pressures and potential market opportunities.

Key Takeaways

• Relmada’s NDB-01 treatment showed a 90% six-month cancer-free rate in Phase 2 trials.
• The company plans to start a registration study for NDB-01 in Q2 of next year, aiming for 2027 approval.
• Sopranolol’s Phase 2 study for Prader-Willi syndrome is set to begin in the first half of next year.
• Financially, Relmada reported $20.6 million in cash and a clean, unlevered balance sheet.
• Insider buying by executives signals confidence in the company’s future prospects.

Financial Results

• Cash and Cash Equivalents: $20.6 million as of Q2 end
• Shares Outstanding: 33.2 million
• Balance Sheet: Described as "very clean" and unlevered
• Financing Needs: Expected but not immediate

Operational Updates

NDB-01 (Gemcitabine/Docetaxel Gel for NMIBC):

• Phase 2 Study: Achieved a 90% cancer-free rate at six months
• FDA Discussion: Planned for Q4 to finalize the registration study plan
• Registration Study: Expected to start in Q2 next year, with completion targeted for 2027

Sopranolol (Subcutaneous Injection for Compulsivity Disorders):

• Initial Indication: Prader-Willi syndrome
• Phase 2 Study: Planned to start in the first half of next year, with a small cohort of 12-15 patients

Future Outlook

• NDB-01: Registration study planned for next year, potential approval in 2027
• Sopranolol: Phase 2 study to begin next year, focusing on Prader-Willi Syndrome

Q&A Highlights

• Competitive Landscape: NDB-01 compared to Johnson & Johnson’s and UroGen’s therapies
• Treatment Costs: Competing therapies priced at $69,000 and $21,000 per treatment
• Urologist Incentives: Economic benefits of using chemotherapy over surgery discussed
• Insider Buying: Recent purchases by executives seen as a positive signal

Readers are encouraged to refer to the full transcript for a comprehensive understanding of Relmada Therapeutics’ strategic plans and insights.

Full transcript - Small-Cap Virtual Conference:

Alex, Host: During the presentation, please feel welcome to submit questions using the Zoom Q&A interface at the bottom of your screen. After the presentation, we’ll open to your questions. With that, Sergio, I’ll turn it over to you.

Sergio Traversa, Co-Founder and CEO, Relmada Therapeutics: Thank you very much, Alex, and thanks for inviting us to your conference. I am Sergio Traversa. I’m the Co-Founder and CEO of Relmada Therapeutics, and I have the pleasure to have with me today Maged Shenouda, who is our long-time Chief Financial Officer. It is a privilege, actually, to have the opportunity to introduce and to update on the Relmada progress, as this year is a very, very important year for the company. Ticker symbol is RLMD. We have been on NASDAQ since 2019, and we have been a public company since 2014. As always, since this is a public company, I invite everybody to carefully read our statement before making an investment decision. Always have to do this. Let’s go with the Relmada update and story. We have been public for a long time, and we had traditionally worked in the central nervous system.

At the end of last year, we decided to move with a different strategy and with the objective of lowering the risk of leaving the upside intact. We did acquire two programs based on the strategy that we are following now. We want to do more animal studies, safety studies, phase one. That’s more for large pharmaceutical companies with different kinds of resources and different overall risk profiles. A company of our size, we decided to go for lower risk programs, and we acquired two this year. That is a pretty nice result in a few months. Today, I would love to focus more on NDB-01. The only reason is that it is the most advanced. It is really what we drive or is driving the value of Relmada over the next year or two.

I also will mention and spend a few minutes on Sopranolol because it is a very, very interesting program. It’s just early stage. It will take some more time to develop and to show the value, but it’s definitely something to keep an eye on. NDB-01. We acquired NDB-01 at the beginning of this year, and it is a technology that has been invented at Tel Aviv University in Israel. It was acquired by a small company in Israel called Trigon that we licensed the program, and we brought the two people, the key people of Trigon on board with us. They have the expertise. We are addressing a disease that is bladder cancer that is very frequent, and it is a particular kind of cancer. We focus on a subset of the largest subset of the bladder cancer. That is the non-muscle invasive bladder cancer.

It is about 75% of the total population affected by bladder cancer. Now, in two seconds, why bladder cancer is different from most of the other cancers, right? First of all, it is rather frequent, right? One out of 25 cancers in the United States is bladder cancer. Fortunately, it is not a lethal cancer if it is treated, right? It’s a cancer that affects mostly men in advanced age, 60, 65, up to like 80, 90, 90 years old, and they have an average duration of the disease that is around 10 years. If treated, bladder cancer is not lethal. The worst consequence of a bladder cancer when it’s treated is to take the bladder off. That’s the objective of the treatment, not to avoid the radical cystectomy because living without bladder, the quality of life is very, very low.

There’s one more feature that is typical of bladder cancer. It keeps on coming back. Half of the patients, the cancer is recurrent after one, up to like 70% to 80% after two years. It needs to be treated, and it’s becoming like a chronic treatment. A few numbers. There are about 70,000 to 80,000 new cancer patients every year in the United States. Because of the long duration of the cancer, the total number of people that are living with bladder cancer, non-muscle invasive, is 700,000 to 800,000. It is a very, very, very sizable number. There are different treatment options for bladder cancer. One thing that I would like to share is that because of the long duration of the cancer, that is an average of 10 years, most of the patients, they kind of go through all these different options.

That goes from surgery to immunotherapy to chemotherapy. When it becomes muscle invasive, then it needs systemic treatment, but that’s a totally different kind of disease. What the patient that is affected by bladder cancer, the journey is, what does it do? The patients find some cells with some blood in the urine, goes to the urologist. The urologist does like a small sample, and unfortunately, the patient sometimes is affected by bladder cancer. The first treatment that everybody goes through is surgery. It’s called TURBT, transurethral resection of bladder tumor. The doctor puts a cystoscope in the bladder and kind of cut away the cancer or the cancers because it can be not unique, but it can be many different small cancers in the bladder wall. After the first surgery, usually the patient takes adjunctive treatment that normally these days is still BCG. That is the tuberculosis vaccine.

That is an immunotherapy. It generates an immune response in the bladder and is supposed to prevent, in some way, the new cancer cell to proliferate. Now, BCG is not very well tolerated. It is a live vaccine. Doctors don’t like to have it in the doctor office. Nurses don’t like to manage live bacteria, and it’s not a preferred treatment. It’s also pretty difficult to find these days, and there is a shortage. There’s been a shortage since the last seven, eight years. It does, it somewhat does work. It prevents the recurrence of the tumor in half of the cases. Even with BCG, still half of the patients, after one or two years, they have to go through the same, mostly through surgery again. These days, the use of chemotherapy inserted in solution in the bladder is becoming more popular for a variety of reasons.

It’s usually better tolerated than BCG, and somewhat it is equally, if not more, effective than the vaccine. The goal of the current treatment, what the urologists are looking at, is to reduce this number of surgeries and to use more immunotherapy. There are a few products in development, not us, in immunotherapy, and to increase the use of chemotherapy. I don’t want to spend a lot of time. I’m not a surgeon on the surgery. Even if it’s not a massive surgery, it still lasts half an hour to an hour. It requires anesthesia and has all the complications of surgery, with some risk of mortality as well, especially if there are patients that do like five surgeries in three years, and that becomes a big burden, especially for patients that are higher risk with the age. They take anticoagulants.

The goal is to reduce as much as possible the number of surgeries. Now, this is a survey. It’s not a proprietary survey. We took it from the Urology Journal. These are what the urologists like to do these days. Intravesical chemotherapy, that’s the preferred treatment for recurrent bladder cancer. Among all the chemotherapies, there is one combination. That is gemcitabine and plus docetaxel. These are two old, widely used chemotherapies that are used for many other kinds of cancers, and they generate the best results. They’ve been published. There are several data published, and they generate the best results in preventing the recurrence of bladder cancer. That’s what we do. Gemcitabine plus docetaxel. The chemotherapy is used on label or off label for many, many, many different ways, from after BCG to BCG naive to patients that cannot tolerate BCG and so on. It is widely used.

It is chemotherapy, so it is supposed to work in most of the cancer cases. The big question is why it is not widely used since it is effective. There are especially the combination that is considered the most effective. There are a couple of issues that affect the combination or the use of this Gendoza, which is the short name for gemcitabine plus docetaxel. One limitation, which is why the use is limited, is the preparation. These are toxic substances. This chemotherapy cannot just be mixed in a glass of water in the doctor’s office because it cannot be handled if they get in touch with the skin. These are toxic substances. They are usually prepared by a specialist pharmacy. Most of the urologists work in a doctor’s office. There is no specialist pharmacy.

The use is somewhat restricted to clinics and universities where there is a specialist pharmacy that can prepare the solution. That is one limitation. The second limitation is the administration. Since these are two components and the volume of the solution is rather big, they cannot be inserted in the bladder together. They have to be done one by one. To make it short, the overall treatment with Gendoza requires four, five, to six hours of the patients in the office. That is a very long time, especially for patients that do not live close to the clinic and that keep the space in the clinic. In university, they are less affected, but in a doctor’s office, this becomes a significant limitation.

The consequence is that despite many urologists who like to use Gendoza, the chemotherapy to treat their patients, they cannot do it because of these two limitations. That is why we come on board. The NDB-01 is an extended release. It is a gel that is formed within the bladder, and it forms a little matrix like the size of a golf ball, very soft, that stays in the bladder and moves around. It delivers over time, in one week to 10 days, the chemotherapy Gendoza. It is an extended release chemotherapy treatment for non-muscle invasive bladder cancer. These are two different graphics of how the products are delivered. You can see that after a couple of hours, that is seven, eight days, the majority of the two chemotherapies are excreted in the bladder. Two things. One, the components, the chemotherapy is widely used.

It’s very well known, and the FDA knows it. Not a lot of questions about that. The efficacy is well proven. We are not reinventing a new treatment. We are just helping the current treatment that is the most wanted by the urologists to be used more frequently and in an easier way. The second one is that we use exactly the same dose they already use. We are not changing really how the doctor is treating, is using this chemotherapy. We are just making it a lot easier and allowing it to use. What are the advantages? One, it is ready to use. It comes in a package. There are two plastic syringes pre-filled. The doctor or the nurse, this treatment can be done by everybody with some experience in urology. They just open the case with the package, and there are the two syringes, the simple catheter.

They put the two gels in, the two solutions in that they form the gel, and that’s it. This treatment can be done, we say, in less than 10 minutes. In reality, we have seen it done. We have done well over 200 administrations now. It takes literally less than five minutes. Ready to use, and it takes really very little time. The patient goes home, and that’s it. The gel dissolves over time in a week to 10 days, and it’s safely excreted with the urine. There is no need to take it off. It’s convenient. It’s sustained release, and it’s already based on a treatment that is considered safe and effective by itself.

The conclusion, the bottom line of this new therapy is that we’ll bring a therapy that is wanted, that urologists want to do from the clinic, the university, to the doctor’s office that will be able to use it easily. That would make a big, big difference for patients and for doctors. One thing that we have to demonstrate, and I believe we did, or we are doing that, is support all this nice technology, elegant, simple, easy to understand, easy to use with data. We are in the middle of toward the end of a phase 2 study. This is an open label. This is cancer. There is no placebo or no comparison. It’s open label, and the patients are treated every two weeks for three months with Gendoza or with NDB-01. Then they do once a month instillation as a maintenance.

It’s a standard treatment protocol for bladder cancer. The patient population reflects the high-risk bladder cancer patient population. No surprises there. It’s a regular patient population with the majority of men and with ages like 65 and above. This is what we have observed, and whoever is experienced in bladder cancer, these numbers are stunning. Just one number that tells you everything: at six months, 90% of the patients are cancer-free. We have one patient at nine months who is doing very well. We will update on the nine and 12 months. The study usually lasts about 12 months. The key number would be the cancer-free at 12 months. These numbers don’t change dramatically over time. We see that 90% at six months are cancer-free.

I do believe, Maged, correct me if I’m wrong, but this is the highest number ever seen in the treatment of prevention of the recurrence of bladder cancer. This is another way to represent the same data. Each line or horizontal is a patient that you can see the same results, right? If you see that at six months, the response or the cancer-free rate is higher than three months, it’s just because the patient that did not, well, like four patients that did not respond at six months have been retreated, and one hasn’t finished that. I believe one or two that have responded at the second treatment. The key number is 90% cancer-free at six months. The market, there are three players. One is us, that we are still in development. One is Johnson & Johnson that just got approval last week.

The other one is UroGen, that is also a company that has developed and they got approval in May of a thermal gel that is used for bladder cancer. There are a few differences. Johnson & Johnson uses a plastic device. They call it a pretzel because of the shape of the pretzels. It’s very effective. They only use gemcitabine, while UroGen only uses mitomycin. It’s an older chemotherapy. We use a combination. It’s what the urology would like to be able to use today. There are some differences, right? Johnson & Johnson, it’s very effective and based on their data. It needs a small surgery. It’s a small, I don’t know how to call it, like an operation to put it in and with anesthesia. After three weeks, the patient has to come back and they have to redo the same thing, take it off, and put another one.

It is not something that can be done easily in a doctor’s office. That most likely, they just got approved. There is no experience on the marketplace, but it usually should be done in a clinic. It is effective. While the UroGen gel can be done in the doctor’s office, it works well. The data are very good. The duration is not much longer than the immediate release. While the regular solution lasts a couple of hours, the UroGen product, according to the label, lasts like four, five, to six hours. It is effective. We think, we hope, and we think that it will be used by the urologists. One thing that I would like to emphasize, I was surprised about the price when UroGen announced their price. It’s $21,000 for each of the treatment. That’s only the gel. It’s done 10 times a year. The annual cost is $120,000.

I was even more surprised when Johnson & Johnson last week announced their price. That is $69,000 for each treatment. Again, done 10 times a year. The total annual cost of using the Johnson & Johnson is $690,000. We don’t have a price, and yet we are still in development. These are big numbers. If you consider there are 100,000 surgeries every year in the United States to treat non-muscle invasive bladder cancer, and the number of patients, number of procedures is pretty high. This is the price. You can imagine that the revenues generated by this product can be significant. Our progress, we’ll discuss with the FDA in the fourth quarter, the plan. We give updates nine months in Q4 and 12 months in Q1 2026 about the phase 2 study when it will be finished.

The goal is to start the registration study in the second quarter of next year and to complete in 2027. We are not that far away from a potential approval. A couple of words before we take your question on Sopranolol. Very interesting program. It’s a subcutaneous injection. The treatment is an effective treatment. There are phase 2 data in Tourette’s syndrome to control compulsive disorder. You may imagine in compulsive disorder there are many, many manifestations of that. There are certain patients that have a neurotransmitter, GABA, system that is overreacting, and they cannot control their impulse. Tourette’s syndrome, Prader-Willi, essential tremors, these are all manifestations of compulsivity. Based on the mechanism and data that’s shown in Tourette’s syndrome, Sopranolol potentially can control the compulsion of these patients. It can be used or can be developed in different indications.

Clearly, we cannot do all of them at the same time. We decided to go for the first one, to Prader-Willi, because it’s a very serious genetic disease. There are 350,000, 400,000 people, they start in their kids. They have this syndrome. There is a big, big unmet need. The compulsion is shown in many different ways, especially eating. These people cannot stop eating. It’s not because they’re hungry. It’s just a compulsion. We hope that Sopranolol will be able to help these patients. We are manufacturing the product, talking with the FDA. The goal is to start phase 2 sometime in the first half, toward the end of the first half of next year. With data, it’s a small study. It’s an orphan indication. 12, 15 patients, we should be able, as a proof of concept, to see if there is efficacy there.

With that said, I would let Maged, our Chief Financial Officer, comment on the situation with the financials. Maged, you’re on the floor.

Alex, Host: Thank you, Sergio, and thank you, Alex, for hosting us. Right. With regard to our financial overview, as of the end of the second quarter, we had $20.6 million in cash and cash equivalents and short-term investments on our books. We have 33.2 million shares outstanding. It’s really a modest number of shares for a biotech company, I would say. We have, which is quite important, what we consider to be a very clean balance sheet. It is unlevered. I think that gives you a good overview of our financials and our capital structure as well. Sergio?

Sergio Traversa, Co-Founder and CEO, Relmada Therapeutics: Thank you, Maged. I think we did well with the time, so we have some time for questions. Alex, you’re on the floor.

Alex, Host: Perfect. Thank you both. You know, a lot of exciting information. Maybe we could turn back to that slide or at least touch on, you had a nice slide about the standard of care in the space, the emerging standard of care and the treatment costs and how expensive it could be versus Johnson & Johnson, UroGen announcements. Could we touch a little bit maybe on outcomes? You know, where does Relmada fit into that? The question from the audience is, how do the treatment outcomes for these compare?

Sergio Traversa, Co-Founder and CEO, Relmada Therapeutics: Yeah, sure. That’s a great question, right? There are significant amounts of data on how chemotherapy, especially the combination that we are developing, is already used. There is no one single way to use it, and it’s an effective treatment. Urologists tend to use their technology or their drugs or their devices where they believe they can be effective. It can be used in many different kinds of patient populations. One thing that I would like to share is that these patients can live an average of 10 years. Already, when they get the cancer, they’re in their 60s and 70s, so it’s kind of a chronic treatment. They usually go through everything with the goal of avoiding taking the bladder off. Clearly, they have to go through one initial surgery to see what kind of cancer they have.

The goal is to preserve the bladder, not to take it off, but also to reduce the number of surgeries because they are heavy. If you have to have like five surgeries in three years, it’s a big burden. You have five anesthesia, and it is a debilitating treatment. BCG is very difficult to place, difficult to find. There are other immunotherapies that are in development that also work well. Ideally, with the urologists, it would be to go through one surgery and then to use immunotherapy, first to use chemotherapy to clean if there are residual cancer cells in the bladder. Chemotherapy would come first, and then to use immunotherapy to boost the immune system, to prevent the insertion of new cancer cells. Usually, it is a rotation of these therapies.

Because the cancer, no matter what, tends to come back, most of the patients tend to use all of this with their goal to reduce the surgery. Chemotherapy and immunotherapy actually go very well together. They are synergistic. About the cost, one thing that I didn’t know, I just learned from urologists, is that the reimbursement for an average surgery for a surgeon or urologist these days is $277. The urologist has to go to the operating room. The operation lasts half an hour to one hour, and then has to go back to his office for $277. Clearly, they do it for the patients, but the income related to surgery is not very attractive for urologists.

On the other side, if we take the, let’s say, the Johnson & Johnson or the UroGen, let’s say the Johnson & Johnson that is the most expensive of this treatment, the urologists, they use the buy and bill. They buy the Johnson & Johnson, the pretzel from the specialized pharmacy, and they use it, and then they bill the insurance. Legally, they can have a markup of 5% to 6%. $69,000 for each treatment, 5% of that is more than $3,000 versus $277. That is not what the decision-making process of the urologist is because the patient comes first. Clearly, there is an incentive also to use this kind of product. The immunotherapy also is relatively expensive. I believe the Ferring product that they’re lasting, it is on the market, it’s done every three months, but it’s $65,000 each. It is a big number. It is a big number.

There is also an economic incentive for the urology community to use more of chemotherapy and immunotherapy versus surgery.

Alex, Host: Great.

Sergio Traversa, Co-Founder and CEO, Relmada Therapeutics: I hope I answered your question.

Alex, Host: Yes, absolutely. Thank you for the context. Let’s do one more quick one. There’s a question that, you know, the financial overview was very helpful. Could we maybe connect it to how that positions you to sort of hit some of the milestones?

Sergio Traversa, Co-Founder and CEO, Relmada Therapeutics: Sure.

Alex, Host: Basically, how your capitalization aligns with your roadmap.

Sergio Traversa, Co-Founder and CEO, Relmada Therapeutics: Yeah, sure. Happy to answer that. Right. You know, it’s no secret that it’s expensive to run clinical trials. We will have to bolster our balance sheet at some point. We’re also very mindful of the share price right now. We feel that, you know, we leave it up to you, to investors, but we feel that there’s a lot of value to be unlocked. Suffice it to say, we will have to address our financing needs at some point, but I don’t think it’s going to be in the immediate future.

Alex, Host: Great.

Sergio Traversa, Co-Founder and CEO, Relmada Therapeutics: Without making big numbers, there is a gap on the value of Relmada today to, let’s say, forget Johnson & Johnson. They have a lot of other things. UroGen, its market cap is about $1 billion. There is a big gap. We do believe, we may have a little bias, but also, according to urologists, NDB-01 potentially can be best in class.

Alex, Host: Right. I would just point to the fact that we had some insider buying recently for what it’s worth. Our CEO bought a significant number of shares, and so did our Chief Medical Officer who oversees the urology program. He also purchased shares.

Sergio Traversa, Co-Founder and CEO, Relmada Therapeutics: It’s part of the document. We had to file the 404.

Alex, Host: You can see that on our 404.

Sergio Traversa, Co-Founder and CEO, Relmada Therapeutics: That’s right.

Alex, Host: Absolutely. This is great. A lot of helpful context for folks new to the name and, you know, a great presentation. With that, we are at time. I’d like to thank you, Sergio and Maged, for sharing the Relmada story with us. I also thank everybody listening for spending time with us today.

Sergio Traversa, Co-Founder and CEO, Relmada Therapeutics: Thank you, Alex. Thank you, everyone that is listening to our call. Thanks a lot. We are easy to reach for any update or any further questions. Thanks again.

Alex, Host: Take care.

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