Q1 2025 Relmada Therapeutics Inc Earnings Call
Speaker Change: Good afternoon, welcome to Relmada Therapeutics, 1st quarter 2025 earnings call. At this time, all participants are in a listen-only mode.
Speaker Change: After the prepare remarks, we will conduct a question and answer session to ask a question. Please press star one. As a reminder, this conference is being recorded and will be available for replay on the location website. I would like to turn the call over to Brian Ritchie from the light side of Iyer. Please go ahead, Mr. Ritchie. Please go ahead, Mr. Ritchie.
Good day, and thank you everyone for joining us today.
Speaker Change: This afternoon, Romada issued a press release providing a business update and notlining its financial results for the three months ended March 31st, 2025.
Speaker Change: Please note that certain information discussed on the call today is covered under the safe harbor provision of the Private Security's Litigation Reform Act. We caution listeners that during this call, Ramada's management team will be making forward looking statements.
Speaker Change: 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.
Speaker Change: These forward-looking statements are qualified by the cautionary statements contained in Relmada's press release, issued today, and the company's SEC filings.
Speaker Change: including in the annual report on Form 10K and today's Form 10Q for the quarter ended March 31st, 2025, 2025, filed after the close today.
Speaker Change: This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, May 12, 2025.
Speaker Change: Relmada undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call.
Speaker Change: With me on today's call, our Relmada 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 Q1 financial results.
Speaker Change: After that, we will open the line for a brief Q&A session. Now, I would like to turn the call over to Sergio Traversa. Sergio?
Speaker Change: Thank you Brian as always, and good afternoon and welcome everyone to the Relmada First
1225 is after good start for a month.
Speaker Change: We add the true unique product candidates with very encouraged and face-to-date-up and large addressable markets to our portfolio, N-D-V-O-1 for bladder cancer and soprano for a Prada Wheelies Syndrome to Red Syndrome and Potentially other CNS invications.
Speaker Change: reported an initial proof of constant face-to-date for our lead product candidate, NVIDIA-1, at the American Urology Association, and we made progress towards our objective of bringing each program to patients as soon as possible.
Speaker Change: With Preparation and their way to begin, the next set of studies for N.D.V.O.1 and CEPROM.
Speaker Change: We two innovative product candidates that have shown proper promise in proof of concept data, 27 million cash balance, clean balance sheet and discipline the approach to development plan. We are in a good position to advance our pipeline to important clinical milestones.
Speaker Change: During today's talk, we'll provide the snapshot or our two programs, including a review of the initial face-to-date for N.D.V.O.D.1 at the A.U.I meeting two weeks ago.
After that, Maged will review our financial results.
Speaker Change: I will make a few closing remarks and then we will take your questions.
Speaker Change: We also invited on the call today, Dr. Yeiro Lotham, chief of Urola Udo Oncology at the University of Texas Southwest America Center in Dallas, who can answer your clinical question regarding
Speaker Change: We are encouraged by the potential of the diversified pipeline that we are building at Belmada. Starting with NDB01, we believe the program is an excellent fit with our strategic plan.
Speaker Change: and has the potential to meaningful improve the care of patients with bladder cancer.
Speaker Change: Our decision to incline since the end of your one was based on strong science, strong field data, and the anticipation of positive face to data at the upcoming American Erology Association meeting or AUA 2025.
Speaker Change: I am pleased to report that positive top-line proof of constant data presented at the U.A. 2025 supported our initial end-to-the-aza.
Speaker Change: for NDBO1's potential to be the class leading blood-serying chemotherapy for non-massal
During today's call, I will touch on the Market Opportunity.
The mechanism of action, the data and the next steps.
Speaker Change: Starting with the market, sources indicated that there are about 75,000 new cases of bladder cancer diagnosed each year in the US.
Speaker Change: About half for 50% of those cases have eye-grade disease that has a high risk of recurrence.
Speaker Change: It is a very high recurrence rate for the 600,000 people approximately in the US living with
Thank you.
Speaker Change: Moving to mechanism of action, NDV01 is a novel, sustained-release, intravesical formulation of two chemotherapy agents, gencitabine and docetaxel, or GEMDOS.
Speaker Change: Andrea I forms a spherical soft matrix within the bladder that sequesteres gem dosi and relieves
Speaker Change: The formulation was specifically designed to maximize local gem dose concentration and also provide prolonged exposure while minimizing systemic toxicity.
Speaker Change: Published clinical studies have shown that gencides have been endocetoxyl, acidose response rate, and recurrence-free survival that are comparable to or better than the historical standard care, but still let's come at get-in or BCG.
Thank you.
However, the administration of conventional chemotherapies comes
Speaker Change: The two chemotherapy agents require special handing in preparation in a control hospital
Speaker Change: In addition, the two chemotherapies are administer sequences over three to five hours with limited
Speaker Change: In contrast, N-D-V-O-1, sustained release formulation is intended to be those in office as a ready-to-use therapy that is administered in less than 10 minutes, without the need for anesthesia or new or dedicated equipment.
Thank you.
Speaker Change: What is really exciting about the interview data is the data.
presented at the AUA 2025 two weeks ago.
Speaker Change: The presentation was based on data from an ongoing single-arm, single-center, XUS Phase 2 study, evaluating NDBO1 in patients with migrates and MIBC.
Speaker Change: 26th patient have been enrolled as of the date of the last date of the course.
Speaker Change: The AOA presentation was based on the results for the first 20 patients.
Speaker Change: The group included two patients with carcinoma in CIDO, CIS, and 18 patients with papular
TANT1
Speaker Change: Of the popularity of these patients, eight were BCG naive and 12 were BCG unresponsive.
Speaker Change: The efficacy data were presented based on three and six months of session.
Speaker Change: In addition, the highest response rate at any time point was also reported.
Speaker Change: Based on the three months of assessment, dosing of NDBO1 results in overall response rate of 85%, or 17 out of 20 patients.
Thank you.
High-grade recurrence-free survival in patients with papillary disease of 83 percent.
for 15 out of 18 patients.
Speaker Change: A complete response in calcium homincy to patients, recognizing that the number is small, was 100% or two out of two patients.
for data report at any time point.
Speaker Change: The overall response rate was 90% or 18 out of 20 patients.
Speaker Change: High-grade recurrence facial bival in papillary disease was 89% or 16 out of 18 patients.
Speaker Change: Complete response in carcinoma in situ patients remains 100% for two out of two patients.
Importantly, seven patients were valued at six months.
100% of this patient achieved disease-based status.
Speaker Change: This group includes one patient with CIS and six patients with papillary disease, characterizes TA or T1.
Speaker Change: One of these patients was re-treated at three months and responded to the second treatment.
Speaker Change: From a safety perspective, NDU1 was well tolerated with no treatment related verse events greater than great ones.
Speaker Change: We were very pleased with the reception of the data received at AUI.
Speaker Change: We believe that the result suggests that N-D-V-O-1 has the potential to significantly improve the care of patients with N-M-I-B-C.
Speaker Change: And even one is currently in continues the phase two single-arm study to assess safety and efficacy in patient with high-grade non-massive-invested bloodlockings.
Speaker Change: Our goal is to bring NDBO1 to patients as soon as possible.
Speaker Change: Look ahead to the second half for 225. Our effort will focus on securing a U.S. I.N.
Speaker Change: Turning briefly to Cipranolon. In February , we are quite the right to Cipranolon from
Speaker Change: Our decision was based on Sopranolon's broad safety database and promises face-to-results
Speaker Change: I would like to touch on four topics for Supreme Law, the market of opportunity, the mechanism of action, the data in the next steps.
Speaker Change: 30 in the market, we believe Cephanolon is well suited to treat disorder marked by compulsive behavior and excessive activity of the GABA Nuretos-Meter pathway, including Prada-Willis syndrome and Tourette syndrome.
Speaker Change: The Sue Neurobehavioral Disorder can manifest through repetitive behavior and inclusivity and represent sizable underserved markets.
Speaker Change: Prada Willi is our first candidate indication for soprano. Prada Willi is a complex genetic disorder often defined by persistent anger and overeating hyperfagia.
Speaker Change: Colin treatment is focused on improving obsessive compulsive behavior and other medical complications.
Speaker Change: Pradal Wily is estimated to affect approximately 350,000 people worldwide, including approximately 20,000 people in the U.S.
Speaker Change: Turning to the mechanism of action. The problem is, first in class, endogenne New York
Speaker Change: It's a member of a new subgroup of neurosuride called Gamdas, or GAFA modulating steroid antagonism.
Speaker Change: Gamsa's selectively act on Gaba to alleviate the repetitive symptom of compulsive disorder.
Speaker Change: We were attracted to Cephanolone because of its unique mechanism of action and promise in
Speaker Change: The Phase II, the results from the originator, Azarina, showed that soprano demonstrated the competitiveness
Speaker Change: Dick's reduction of 28% with a p-value of 0.051 in its primary clinical point, as measured by the YGTSS Standardized Thread Scale.
Speaker Change: The data also showed that the front-run treatment produced an improved quality of life without any off-target CNS.
Infects
Speaker Change: These data provide a strong foundation to study the Prano-incompulsion related disorders such as PWS, or Prado-Willian Syndrome.
Speaker Change: However, to progress the plan alone are expected to include planned FDA interaction and further development of product supply, with plans to advance inter-clinical development in early 2026.
Speaker Change: Now, I would like to turn the call over to our Chief Financial Officer, Maged Shenouda, to talk about our financial results.
Megan.
Maged Shenouda: Thanks, Sergio. With two innovative product candidates that have shown promising proof of concept data, a $27.1 million cash balance, a clean balance sheet, and a discipline development plan, where in a good position to advance our pipeline to important clinical milestones.
Turning to our financial results.
Maged Shenouda: As noted by Brian , this afternoon we issued a press release announcing our business and financial results for the first quarter ended March 31, 2025.
Maged Shenouda: As of March 31, 2025, Relmada had cash, cash equivalents, and short-term investments of approximately $27.1 million, compared to $44.9 million as of December 31, 2024.
Maged Shenouda: Cashers and Operations in the first quarter ended March 31, 2025, with $18.1 million compared to $13 million for the same period in 2024.
Maged Shenouda: Our efforts in 2025 are dedicated to advancing NDV01 and soprano through key development milestones.
Maged Shenouda: Over the coming months, as we finalize our clinical and regulatory strategy for each program, we expect to have better visibility into our requirements and runway.
Moving through our first quarter, 2025 financial results.
Maged Shenouda: Research and Development extends for the first quarter of 2025, total $12 million compared to $13.3 million for the first quarter of 2024, a decrease of $1.3 million.
Maged Shenouda: The lower spend was primarily driven by lower study costs, with a completion of clinical trials for rail 1017 for major depressive disorder, offset by payments for this panel and acquisition and the NDBO1 in licensing.
Maged Shenouda: General and administrative expense for the first quarter of 2025 totaled $6.3 million, compared to $9.7 million for the first quarter of 2024, a decrease of approximately $3.4 million. The decrease was primarily driven by a decrease in stock-based compensation experience.
Maged Shenouda: The net laws for the first quarter of 2025 were $17.6 million or 58 cents per basic and eluded share, compared with the net laws of $21.8 million or 72 cents per basic and eluded share for the first quarter of 2024.
Sergio Traversa: Before we open the call for questions, I'll turn back to Sergio for some closing comments,
Thank you, Maged
Sergio Traversa: I would like to leave you with these key messages from today's call before we enter in the Q&A section.
Sergio Traversa: 2025 is off to a strong start with the addition of two unique product candidates with proven constant face-to-date and large-addressable market to our performance.
Sergio Traversa: N-D-V-O-1 for bladder cancer and soprano known for Prader-Willis Inderman to read it.
Sergio Traversa: Reported positive initial proof of constant phase two data for our lead product candidates NDV1 at AUA, and we made progress toward our objective of bringing each program to patient as soon as possible.
Sergio Traversa: with Preparation underway to begin the next set of studies for NVO1 and CEPRONO.
Sergio Traversa: We tune over the product candidates that have shown promise in group of concert dates, 27 million.
Sergio Traversa: Cash Balance, a clean balance sheet, and a disciplined approach to development plan, we are in a good position to advance our pipeline to important clinical management.
Sergio Traversa: As we prepare to advance our true clinical program, we want to thank our investor for your support and for taking time to join today call.
Sergio Traversa: A greater would like now to open the call for its four questions.
Speaker Change: Thank you. If you would like to ask a question, please press star one on your telephone keypad. A confirmation number indicate your line is in the question queue. One moment will we pull for questions?
Oyer: Ibrahim. Our first question is from Oye Ear, Whitman, Zooho Securities. Please proceed.
Hey guys, yeah, thanks for taking your questions and comments on there.
Oyer: You know, you indicate you'll be approaching the FDA to speak with them to an order to move forward.
Speaker Change: I guess what gives you confidence that the current data from the Phase II study would be sufficient for the FDA to agree, for MD-V01 to move into registration of studies.
from...
and I guess...
Speaker Change: The second question maybe is, you indicate that you're going to...
Speaker Change: Can you sort of elaborate what you mean by data? Is this are they commercial products? Are they scaling up for clinical study only?
Thanks.
Thank you. Thank you. Thank you.
Thank you, I...
for the question. Let me answer the first one and...
Speaker Change: The beginning of the start of registration of a program, but a couple of things. One is the combination of drug itself, right? Genocide has been used, has been currently used and has been used for some time by many, many urologists everywhere, and everybody is convinced about the...
Speaker Change: The efficacy and the safety of the local administration of the outer two drives.
Speaker Change: The reason that has not been more widely used is the limitation in the practicality.
The very few doctor office can prepare the...
Speaker Change: The solutions are, that's to be prepared by pharmacy, self-provide, used to handle chemotherapy, most of the cases in clinics. So, and the administration that requires a sequential.
Speaker Change: Jaisai Tabin, and Dosetak, so one after the other, and it takes time. So you have to keep by the doctor office of the clinic occupied for three, four, five hours, and for the patient through because you have to see it in the...
Speaker Change: in the clinic holding for one or two hours each of the two preparations.
Speaker Change: That even if a patient affected a bladder cancer is willing to go through a lot to avoid to take the bladder off is still a convoluted process.
Speaker Change: And so that's one of the reasons that we feel confident that the combination of chemotherapy is not new, as well known as being easy news and is recognized as one of the most effective and not the most effective pharmacological treatment of whole bladder cancer.
Side Effect
and all the side of the fact registered, all great one.
So, it seems it's very, very well tolerated.
Speaker Change: and so you put the two things together and the advantage also of the administration in the doctor office, non-Esthesia, less than 10 minutes, is it prefil the syringe that doesn't need any handling, so all the things together should maybe have the like willing to let us go into a larger registration study, of course there is always like until we get the direct the minutes from the FDA you cannot be
Speaker Change: Never be sure, but we believe that this is a very good thing.
A very good chance.
Speaker Change: They will be okay with that. And I know if Dr. Olasana has been able to join the call. It was in the surgery stuff.
Yeah, good afternoon.
Can you hear me okay?
Speaker Change: Yes, absolutely, very well. So I think you're going to address the issue to some degree. First of all, Inter-Vesco Chema Therapy has been...
Speaker Change: Routinely used for treating both intermediate risk and high risk bladder cancer.
for decades now.
Speaker Change: It's interesting because the therapies that are currently used might amize in gyms side of being that the tax hole.
Speaker Change: are all being used as off-label use, but there are reimbursed and commonly utilized. The biggest challenge for you to draw this though is that you need a hood to mix the bead formulation, then unless you have a cancer center for pharmacy.
You can't give it in your office.
Speaker Change: Immune Therapies like BCG come in a vial and a powder that you can reformulate, but the interracal chemotherapy you can't.
Medical oncologist who give IV doses of the chemotherapy.
Speaker Change: are not typically giving inter-vegial therapies in their offices. They're not familiar with place in catheters, there's little reimbursement.
Speaker Change: and so you have a bit of a catch-win, too, if you're a patient, you can't really get it in your urologist's office and you can't get it in your medical oncologist's office.
Speaker Change: Catruda and Tartu-Hunter and Krita Stimaging, and Antifa, there's a lot of drugs being developed in this space, and yet, many people are still using gyms, try to be in dose attacks all because the other drugs, well some of them are not approved yet, some of them are more problematic to give in the clinic.
Speaker Change: But many patients are kind of out in the cold. They're not able to get access to these drugs, either the newer drugs or drugs like Gymscybing does the tax on. Now in terms of efficacy
Speaker Change: And I think that this combination, which has advantage of both being easy to deliver, and a sustainable release in the bladder over two weeks, will be superior.
Speaker Change: potentially over agents that stain your bladder for just one hour. So there are several potential advantages for this, both in terms of ease of use and the potential increased efficacy.
Thank you Dr. Lawton.
We didn't answer your question.
Speaker Change: Yeah, so maybe just some follow-up on, you know, what you guys said in response to...
Speaker Change: You have BCG, you have CGM College and other potential competitors who could be ahead. Thanks.
Right, you know, I think I'm happy to respond. First of all,
You know...
Speaker Change: to keep their bladder. And in the BCG on Responsive Space, which I completely agree, there's probably three or four potential treatments.
Speaker Change: You know, TAR-200 and Creative Symmagine both will likely be accepted by the FDA.
Speaker Change: But nonetheless, patients are frequently going to want two or three lines of therapy and they're going to want to try to sort of the most efficient effective treatments.
Speaker Change: I don't necessarily think that that's going to be the best first place to go with with this drug mainly because as you say it's going to be a bit of a busy space even though I suspect that since many people are already using Gempside have been those attacks all as their main treatment
Speaker Change: Off Label if they actually have an approved compound that they're familiar with.
Speaker Change: with durable excretion of drug and an easier mechanism of delivery, then they'll be very open to giving that drug that they're familiar with over some of the other agents.
Speaker Change: But another hand in the intermediate risk phase, which has a higher prevalence by far than the
The Really Aren't Drugs
Speaker Change: that are commonly used. Interversal Gypsy to be is, you know, is available, not approved, but available, but as I said it's hard to get access to. So an academic center is we give Interversal chemotherapy, but many community sites don't. And so it would be a very natural fit to give Interversal chemotherapy such as this formulation from intermediate risk patients.
Speaker Change: It has potential in the chemo-bladed space as well, which even though that's not sort of a place that we commonly use drugs but...
Speaker Change: UGN102 is doing, did a chemoblation trial and it's going to FDA and it's a single drug, mydomycin, this is actually a combination which I think could potentially compete nicely if it had a good performance.
Speaker Change: And there's a bridge trial comparing Jim Dosey to BCG that's being enrolled right now. And if it shows equivalence or superiority, then this drug can fit in the BCG naive space. And the other drugs that you're mentioning, Tartu-Hunter, Criticimaging, are not competing in that space.
Speaker Change: and the trials that have been completed with BCG and checkpoint inhibitors have shown, Christ has been reported how about a 7% increase reduction in recurrence at 18 months, but [inaudible]
Great Three S.A.E.s.
Speaker Change: and no improvement in progression, no improvement in survival, so I don't think any of the checkpoint inhibitors are going to compete in the BCG NAV space.
Speaker Change: But if the bridge trial shows equivalence of efficacy, this drug could actually fit in the BCG knife space without much competition from some of these newer agents. So I see many potential uses right now.
Okay, thank you.
Thank you Dr. Lawton.
Speaker Change: And your second question was regarding the manufacturing and sorry, it was for the Prano or for N.D.V.01, for N.D.V.01.
Speaker Change: But yeah, clearly the quantity needed for commercial will be large so we always want to have two manufacturers at minimum so we are looking for capacity and a second manufacturer for like the Reese Management.
Speaker Change: It's not a complicated product to make, it's gel and so the all known components.
Okay. Thank you.
Thank you, Lee.
Speaker Change: Our next question is from Andrew Tai with Jeffries, please proceed.
Speaker Change: Good afternoon. This is Matt Barcus on for Andrew. Thanks for taking our questions.
Speaker Change: I guess regarding the latest dataset for NDV01 presented at the AUA meeting earlier, when should we look forward to you sharing the complete response rate for the entire population and how do you anticipate sharing the future updates from the program, like what more can we look forward to in those datasets throughout the year and what are your expectations for success?
Thank you.
Speaker Change: Well, I can answer part of it and maybe Dr. Lotan can expand. So the next data point will be the six months. We have seven patients now at the AOA with the 100% complete response.
Speaker Change: We'll have six months date of the 20 patients somewhere around end of June , July , we'll present that and then date that and then we'll give 9 and 12 months of the 20 patients.
Speaker Change: We can only look at what we have now, that is like 90% at 3 months and 100% of the 7 patients at 6 months, but they look pretty good. And no surprising, because it's known that the combination in genos is very efficacious. And even if like with the duration of tour.
Speaker Change: A contact of a couple of hours, we use the same dose and the stays there for 10 days and there's done six times in three months. So the expectation that the results are good are definitely, definitely there. And you want to add something, Dr. Lutton?
Speaker Change: There's a lot of data about efficacy of gem-dosey formulations and...
Speaker Change: We know that, you know, you could look even at TAR-200 data and see what happens when you give Gempsi to be in over a sustained period of time.
Speaker Change: But the safety is actually a more important component because you worry whether or not to belong to exposure of the bladder to the chemotherapy.
Mike Caz, Eurotation, Frequency Urgency, Pain Eurotation,
Speaker Change: And so far we haven't seen that and that's probably if you had asked me at the beginning of this what would it be my biggest concern it would not have been an efficacy concern it would have been a safety concern and so that's probably the most reassuring aspect of it.
Speaker Change: At some point, obviously, after conversation that we can decide on which indication to actually do a larger cohort, but the safety profile is obviously quite reassuring.
Speaker Change: Thank you, thank you, Dr. Lawton. Did they answer your question? There was a first part that they didn't catch entirely.
Speaker Change: No, yeah, yeah, you caught it, thanks. Oh, thank you. And then I guess like as you're thinking about talking with FDA on with these data and the design of the Phase 3, I guess what would you want the Phase 3 to look like in terms of time points and points and the types of patients you're thinking about rolling?
Speaker Change: Dr. Lotten, here you can add a lot of value. Dr. Lotten is helping us very closely to design the Phase 3 program.
Do you want to answer that?
Sure. I think there is.
You know...
Speaker Change: There are easier routes and they're harder routes. I think somebody highlighted.
The Challenge with the BCG Unresponsive Route.
Speaker Change: The benefits of that route are that FDA has approved single arm phase 2 trials for approval in CIS alone to look at efficacy. The challenge is that these patients are relatively rare and it takes many sites and quite a bit of time to enroll.
Speaker Change: I think there's two easier routes. One route would be to go through a single-arm chemo ablation route, similar to what Yura Gen with the Envision Trial.
Speaker Change: I think we're going to learn a lot later on this month when it goes to ODAQ.
Speaker Change: and if the drug, their combination gets approved with a single agent, mydomycin, that stays in your bladder about four hours, and then a single arm trial and that setting with our formulation makes a lot of sense. It would be probably the quickest route to approval.
If that doesn't, if there's reasonable.
Speaker Change: Ration Al from the FDA that they want to prove such an approach.
Speaker Change: Then a randomized trial like Pivot 6 and then intermediate risk randomizing NDV01 to placebo or observation, which probably be the next quickest route. That trial actually enrolled extremely quickly in the US. I think that this formulation would actually be more attractive than an on-calytic virus.
Speaker Change: But that type of trial design was enrolling very rapidly, they're almost done with enrollment, and I think somewhere around 15 to 18 months.
Speaker Change: and I think that would be the next approach, especially since FDA approved a randomization against
Speaker Change: Placibo, which is easy to do a superiority trial against nothing in a population of patients who have a high risk for recurrence.
Speaker Change: There are no further questions at this time, so this will conclude today's conference. You may disconnect your lines at this time and thank you for your participation.
Speaker Change: Thank you all, thank you very much. Thank you, Dr. Leland.
Speaker Change: Stewart Hemlings Bock gus Tim McGehee James Joseph Stuart McCarthy http://www.youtube.com.action-circlelineartschool.com