Relmada Therapeutics Q1 2026 Earnings Report

Relmada Therapeutics EPS Results

• Actual EPS: -$0.22
• Consensus EPS: -$0.18
• Beat/Miss: Missed by -$0.04
• One Year Ago EPS: N/A

Relmada Therapeutics Revenue Results

• Actual Revenue: N/A
• Expected Revenue: N/A
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

Relmada Therapeutics Announcement Details

• Quarter: Q1 2026
• Date: 5/12/2026
• Time: After Market Closes
• Conference Call Date: Tuesday, May 12, 2026
• Conference Call Time: 4:30PM ET

Relmada Therapeutics (NASDAQ:RLMD) is a clinical-stage biopharmaceutical company focused on the development of novel therapies for pain and other central nervous system (CNS) disorders. The company applies a proprietary stereochemical approach to optimized drug candidates, aiming to improve safety, tolerability and efficacy profiles compared with existing treatments. Relmada’s research efforts center on modulation of NMDA receptors to address unmet needs in depression, neuropathic pain and related indications.

Relmada’s lead product candidate, REL-1017 (d-methadone), is being evaluated as a potential rapid-acting and maintenance treatment for major depressive disorder, with clinical studies underway to assess its utility in both acute and long-term settings. In parallel, the company is advancing additional pipeline programs targeting neuropathic pain, including diabetic neuropathy and chemotherapy-induced peripheral neuropathy. Relmada collaborates with academic centers and contract research organizations to conduct multi-center trials across North America and Europe.

Headquartered in New York, Relmada Therapeutics was incorporated in Delaware and maintains its research operations in the United States. The company is led by a management team with extensive experience in biopharmaceutical development, regulatory strategy and commercial planning. Relmada’s common stock is listed on the NASDAQ under the symbol RLMD.

Relmada Therapeutics Q1 2026 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Relmada said it remains on track to initiate the phase III RESCUE program for NDV-01 in mid-2026, supported by FDA alignment and a newly completed $160 million private placement.
• Positive Sentiment: The company highlighted strong 12-month phase II NDV-01 data in high-risk NMIBC, including a 95% complete response rate at any time and durable 76% CR at 12 months, with no progression to muscle-invasive disease or radical cystectomy.
• Positive Sentiment: Management emphasized NDV-01’s favorable safety profile and office-friendly delivery, saying it can be administered in under five minutes without a specialized pharmacy, which they believe could support real-world adoption.
• Positive Sentiment: Relmada filed a provisional U.S. patent application for NDV-01 formulations and methods of treatment that, if granted and expanded globally, could extend coverage into 2047 and strengthen commercial exclusivity.
• Neutral Sentiment: The company ended Q1 with $234 million in cash and said it expects that runway to fund operations through 2029, including completion of the NDV-01 phase III program, while also preparing a mid-2026 proof-of-concept study for sepranolone in Prader-Willi syndrome.

Presentation

[Operator]

Good afternoon, and welcome to Relmada Therapeutics first quarter earnings conference call. I would now like to turn the call over to Brian Ritchie from LifeSci Advisors. Please go ahead, Mr. Ritchie.

[Brian Ritchie, Managing Director at LifeSci Advisors]

Thank you. 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 ended 31st March 2026. 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 today's 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 10-Q filing for the quarter ended 31st March 2026, filed after the close today.

[Brian Ritchie, Managing Director at LifeSci Advisors]

This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast on 12th May 2026. 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, Dr. Raj Pruthi, Relmada's CMO, Urology, who will provide an NDV-01 program update, and Relmada's CFO, Maged Shenouda, who will provide an update on sepranolone and a review of the company's Q1 financial results. After that, we will open the line for a brief Q&A session. I would like to hand the call over to Sergio Traversa. Sergio.

[Sergio Traversa, CEO at Relmada Therapeutics]

Thank you, Brian. Good afternoon, and welcome everyone to the Relmada first quarter 2026 conference call. Relmada continues to make excellent progress this year, and we are excited about where we stand. The robust 12-month data for NDV-01 in non-muscle invasive bladder cancer, or NMIBC, and the successful completion of a $160 million private placement financing, meaningful milestones that reflect the strengths of our progress. Importantly, we remain on track to initiation the phase III RESCUE program in mid-2026, which we believe will be a transformational moment for Relmada. Let me briefly describe what makes NDV-01 distinct. NDV-01 is a ready-to-use, sustained-release, intravesical formulation of gemcitabine and docetaxel, or Gem/Doce. It's designed to build on a well-established safety and efficacy profile of conventional Gem/Doce and deliver a best-in-class therapy for patients living with NMIBC.

[Sergio Traversa, CEO at Relmada Therapeutics]

We remain focused on maximizing its potential for success for patients, the urology community, and our investors. Let me walk you through four milestones that speak to the momentum we have built this year. Number one, we have continued to de-risk the development of NDV-01 with the report of solid and durable 12-month efficacy data from the ongoing phase II study of NDV-01. We will be presenting this data and an overview of the phase III RESCUE program at the American Urological Association 2026 annual meeting later this week. High response rates, a favorable safety profile, and ease of use continue to strengthen our conviction that NDV-01 has the potential to provide what urologists and patients with NMIBC need, a simple, durably effective treatment that readily fits into real-world practice setting.

[Sergio Traversa, CEO at Relmada Therapeutics]

Number one, we achieved FDA alignment for our planned registration of phase III RESCUE programs. Number three, in April, we filed a provisional patent application in the U.S. directed to formulations and methods of treatment for NDV-01. This application, if issued, could form the basis for worldwide patent filings and have a term into 2047. Lastly, we have fortified our balance sheet. With the private financing that was completed in March, we have the resources to support completion of the phase III RESCUE program. Before I hand the call to Raj, I want to underscore the significance of the patent filing. The provisional application is directed to both the formulations and method of treatment, reflecting the breadth and novelty of the NDV-01 platform. If granted, it could form the basis for worldwide patent filings, significantly expanding our global IP protection.

[Sergio Traversa, CEO at Relmada Therapeutics]

Most importantly, it would meaningfully extend the coverage, covered claims of NDV-01 into 2047, providing a nine year extension of commercial exclusivity and strengthening our competitive positions as we advance toward registration. Looking ahead, as we enter the second half of 2026, our focus is on execution. We remain on track to initiate the registration of phase III RESCUE program for NDV-01 in mid-2026. We are also preparing to initiate approval concept study for sepranolone in Prader-Willi syndrome, targeted for mid-2026. Maged will speak about it in more detail shortly. Next, I'll turn the call over to Dr. Raj Pruthi, who will provide a review of the NDV program, including 12 months follow-up data from the ongoing phase II study and the summary of our phase III plans. Raj?

[Raj Pruthi, CMO, Urology at Relmada Therapeutics]

Thank you, Sergio. Good afternoon, everyone. I'm delighted to provide an update of NDV-01 and our upcoming presentations at the AUA meeting this coming weekend. The AUA is an important platform for us as we look forward to introducing NDV-01 to the broader urology community, building awareness of NDV-01 as a differentiated sustained release Gem/Doce, and generating investigator interest in the phase III RESCUE program. Bladder cancer is one of the most common cancers we see, and its impact on the patients is significant. Most are diagnosed in their mid-seventies. The disease often comes with high recurrence rates and intensive treatments that can greatly affect quality of life during a stage of life when preserving it is especially important. I want to touch on three topics during today's call. First, a recap of the NDV-01 12-month data. Second, a summary of our planned phase III program.

[Raj Pruthi, CMO, Urology at Relmada Therapeutics]

Third, a discussion of how NDV-01 might fit in the real-world practice of a urologist. As Sergio Traversa noted, NDV-01 is a novel sustained release intravesical formulation of gemcitabine and docetaxel. It builds on physicians' established familiarity with conventional Gem/Doce. This is particularly meaningful for patients who are unresponsive to BCG, where bladder-sparing options that avoid radical cystectomy can be life-changing. Turning to the 12-month data, NDV-01 has demonstrated high response rates and durable efficacy in our ongoing phase II study. We believe these results compare favorably to other programs in this space and support NDV-01's potential as a best-in-class treatment for patients with bladder cancer if approved. The phase II study is an open-label single-arm trial in patients with high-risk NMIBC. Patients receive six biweekly doses, that is every other week, followed by monthly maintenance for up to one year. Regular assessments include cystoscopy, cytology, and biopsy if needed.

[Raj Pruthi, CMO, Urology at Relmada Therapeutics]

The study was designed to enroll up to 70 patients. Primary endpoints are safety and complete response rate at 12 months. The data demonstrated a 95% complete response rate at any time and a durable 76% CR at 12 months in the high-risk NMIBC patients, and a 94% CR at any time and a durable 80% CR rate at 12 months in the difficult-to-treat BCG unresponsive subpopulation, reinforcing its best-in-class potential in NMIBC. No patients had progression to muscle-invasive disease, and no patients underwent a radical cystectomy. On the strength of these findings, we are advancing NDV-01 into a phase III RESCUE registrational program. The program will evaluate NDV-01 in both second-line BCG unresponsive disease and in intermediate-risk bladder cancer as an adjuvant therapy following transurethral resection or TURBT. We will be presenting the 12-month data set at the AUA annual meeting this Friday.

[Raj Pruthi, CMO, Urology at Relmada Therapeutics]

We believe these data are compelling and look forward to the discussion they will generate in the urology community. Given the burdensome nature of the existing bladder cancer therapies, safety remains a critical aspect of the therapy's overall profile. We continue to be encouraged by the favorable safety profile observed for NDV-01 in our clinical program. In the 12-month data set, no patients experienced a grade three or higher treatment-related adverse event. There were no dose interruptions or discontinuations due to adverse events, and most treatment-related adverse events were grade one. Now turning to the phase III RESCUE program. We designed the program with two separate approval pathways to increase the likelihood of success while creating the most streamlined route to regulatory approval.

[Raj Pruthi, CMO, Urology at Relmada Therapeutics]

We expect to file the U.S. IND and initiate RESCUE program across an estimated 80 sites in North America in mid-2026. The RESCUE program will also be highlighted in the Trials in Progress session at the AUA Annual Meeting on Sunday, May 17th, providing an important opportunity to engage the urology community. Let me now walk you through each of the two studies that form the RESCUE program. Registrational Pathway one focuses on patients in the 2nd-line setting, patients who are BCG unresponsive with carcinoma in situ, or CIS, and refractory to 1st-line therapies that are approved or in development. We estimate approximately 5,000 patients per year in the U.S. fall into this setting. With few effective alternatives to radical cystectomy, this study is designed as a single-arm trial. The primary endpoint is complete response rate at any time.

[Raj Pruthi, CMO, Urology at Relmada Therapeutics]

Secondary endpoints include duration of response, progression-free survival, and recurrence-free survival. We expect to report the first three month response data around year-end. This pathway could offer a rapid route to approval. Registrational Pathway number evaluates NDV-01 as an adjuvant therapy following TURBT in patients with intermediate-risk NMIBC. We estimate approximately 75,000 patients per year in the U.S. fall into this setting. Since no approved treatments exist in this setting, the study is designed as an open-label, randomized controlled trial comparing NDV-01 versus observation. The primary endpoint is disease-free survival. Secondary endpoints include high-grade recurrence-free survival, progression-free survival, and quality-of-life endpoints. We see this as a very attractive opportunity to incorporate NDV-01 into patient care after TURBT and pave the way for broader adoption. Let me share our thinking on how NDV-01 might work in the real-world practice of a urologist.

[Raj Pruthi, CMO, Urology at Relmada Therapeutics]

NDV-01 is formulated to create a soft matrix in the bladder, enhancing local urothelial exposure while minimizing systemic toxicity. It can be delivered in the office by a nurse or LPN in under 5 minutes and does not require a specialized pharmacy or hub. This streamlined administration model offers a level of convenience and time savings that differentiates NDV-01 from other agents. As I hand the call over to our CFO, Maged Shenouda, I want to emphasize why we're so excited about NDV-01. Our phase II data gives us high confidence in the RESCUE. We believe NDV-01 addresses a clear unmet need with a unique sustained delivery platform and has the potential to redefine the standard of care in bladder cancer. Maged?

[Maged Shenouda, CFO at Relmada Therapeutics]

Sure. Thanks, Raj, and good afternoon, everyone. Today, I'll spend a few minutes on sepranolone and then provide you with an overview of our first quarter 2026 financial results. Sepranolone is a novel neurosteroid that modulates GABA, one of the most important neurotransmitters. Sepranolone is intended to act on the GABA neurotransmitter pathway to normalize the activity of the GABA A receptor and alleviate the repetitive symptoms in compulsivity disorders. These disorders affect millions of people around the world and include obsessive-compulsive disorder, Tourette syndrome, and Prader-Willi syndrome. We plan to initiate a proof-of-concept study in Prader-Willi syndrome in mid 2026. Our immediate preparations are focused on engaging with the FDA regarding our proposed trial design and putting a robust supply chain in place. Moving now to our financial results.

[Maged Shenouda, CFO at Relmada Therapeutics]

As noted earlier by Brian, this afternoon, Relmada issued a press release announcing our business and financial results for the 1st quarter ended 31st March 2026. During this call, I will provide a high-level review of our financial results and refer you to our press release and 10-Q filing issued this afternoon with more detailed information. Starting with our cash balance, Relmada closed the 1st quarter of 2026 with a cash balance of $234 million compared to $94 million at 31st December 2025. Our 1st quarter cash balance includes net proceeds of approximately $150 million from a private financing announced March 9, 2026. We expect our current cash resources to provide sufficient runway to fund company operations through 2029, including completion of the phase III RESCUE program for NDV-01.

[Maged Shenouda, CFO at Relmada Therapeutics]

Moving briefly through our first quarter financial results. Research and development expense for the three months ended 31st March 2026 totaled $8.1 million, compared to $12 million for the three months ended 31st March 2025, a decrease of $3.9 million. The decrease was primarily attributable to non-recurrent costs associated with the acquisition of sepranolone and the license agreement of NDV-01 in 2025. This 2026 decrease was partially offset by increased costs related to the startup of the phase III NDV-01 trials and phase II-B sepranolone study and additional R&D personnel.

[Maged Shenouda, CFO at Relmada Therapeutics]

General and administrative expense for the three months ended 31st March 2026, was $11.4 million compared to $6.3 million for the three months ended 31st March 2025, an increase of approximately $5.1 million. The increase was primarily driven by an increase in compensation costs, partially offset by a decrease in stock-based compensation costs. Net cash used in operating activities for the three months ended 31st March 2026, totaled $15.1 million compared to $18.1 million for the same period in 2025.

[Maged Shenouda, CFO at Relmada Therapeutics]

The net loss for the three months ended 31st March 2026, was $19.1 million, or $0.22 per basic and diluted share, compared with a net loss of $17.6 million or $0.58 per basic and diluted share for the three months ended 31st March 2025. Before we open the call for questions, I'll turn back to Sergio for some closing comments. Sergio.

[Sergio Traversa, CEO at Relmada Therapeutics]

Thank you, Maged. In closing, I'm very confident and optimistic about our clinical programs and the long-term prospects for Relmada. As we are getting ready to initiate the RESCUE registrational program for NDV-01 in mid-2026, we are focused on execution and look forward to updating you on our progress in the coming quarters. Operator, I would like now to open the call for questions.

[Operator]

Yes, sir. Thank you. As a reminder, if you would like to ask a question, please press star one on your telephone keypad. Please stand by while we compile the Q&A roster. Thank you for waiting. We now have our first question, and this comes from Kelsey Gold from Piper Sandler. Your line is now open. Please go ahead.

[Kelsey Gold, Analyst at Piper Sandler]

Hey. Thanks for taking my questions. Looking forward to seeing the data this weekend at AUA. I guess a couple from me, if you don't mind. First, for AUA this weekend, it seems like there's some gemcitabine presentations. I guess how should we think about the growing literature on gemcitabine and the degree of read-through to NDV-01? Secondly, maybe just updated thoughts on how we should think about this first look at the BCG unresponsive second-line data later in the year. Maybe how many patients we might see or how to benchmark that. I'll leave it at that. Thank you so much.

[Sergio Traversa, CEO at Relmada Therapeutics]

Thank you, Kelsey. Sergio here, good afternoon. Well, maybe I can take, like, a little point on the first question. I see the, you know, gemcitabine, conventional gemcitabine data always as a positive because it just consolidate how urology, the urology community, believes that this is a very effective and way to treat bladder cancer. With that said, I let Raj to expand and answer you the second question. Raj.

[Raj Pruthi, CMO, Urology at Relmada Therapeutics]

Yeah. Thanks for the question, Kelsey. You know, I'm excited as a urologic oncologist to see the number of non-muscle invasive bladder cancers in general in the hundreds at the AUA this year. You're right, there's a significant number of gemcitabine papers being presented more and more on the efficacy of gemcitabine, especially in the high-risk patient population. The other that I think is notable is that of time toxicity with gemcitabine. There's two papers being presented on the burden of conventional sequential gemcitabine time toxicity, the burden to the patient and to the provider. I think that provides really tees us up to address that time toxicity with our sustained-release formulation. Regarding I think your second question was on our cohort two way for the second-line BCG unresponsive.

[Raj Pruthi, CMO, Urology at Relmada Therapeutics]

You know, my hope in that is that by, you know, as we get this study going, that we'll have a handful of patients maybe by the end of this calendar year that will be able to share three month data. You know, this is an open label study, so a three month response and safety rate data by the end of this year or early next year. We anticipate at a cadence of every three months sharing that data into 2027. I think I got both of your questions.

[Kelsey Gold, Analyst at Piper Sandler]

Perfect. Thank you so much.

[Sergio Traversa, CEO at Relmada Therapeutics]

Thank you, Kelsey.

[Operator]

Thank you. The next question comes from Christopher Lui from Lucid Capital Markets. Your line is now open. Please go ahead.

[Christopher Lui, Managing Director at Lucid Capital Markets]

Thank you. Congrats on the progress you guys have been making so far. For my question, I was just wondering what your updated thoughts are going into this AUA update in terms of what would be a positive readout for you guys at this 12-month mark, in your opinion.

[Sergio Traversa, CEO at Relmada Therapeutics]

Thank you, Chris. Sergio here. I would let Raj, the AUA expert, to answer this one. Raj.

[Raj Pruthi, CMO, Urology at Relmada Therapeutics]

Yeah. I think, you know, I really kind of hone in on the BCG unresponsive population. I think that's the most difficult to treat at failing BCG. I think for our BCG unresponsive, we see numbers of 80% landmark and 84% KM at the 12-month standpoint, which I think is best in class. I think you see approved agents, the best in-class approved agents for BCG unresponsive with CIS are around 45%. I think others have seen numbers up towards 70%. I think the numbers of 80% and 85% that we have are really best in class at that point, and along with a good safety profile.

[Raj Pruthi, CMO, Urology at Relmada Therapeutics]

I think, Chris, I think that's the number that I would kinda look at is that 80% number.

[Christopher Lui, Managing Director at Lucid Capital Markets]

Got it. I appreciate the color. Thank you.

[Raj Pruthi, CMO, Urology at Relmada Therapeutics]

You bet.

[Operator]

Thank you. The next question comes from Uy Ear from Mizuho. Your line is now open. Please go ahead.

[Uy Ear, Analyst at Mizuho]

Hey, guys. Yeah, thanks for taking our questions, and congrats on all the progress you've made. Maybe just help us to understand a little bit more about your patent estate. You filed the provisional patent, and I'm not sure I quite understand the phrase, if approved, patents claiming priority to the provisional patent would have extended patent life, I guess, into 2047. Could you maybe just help clarify that, what that means exactly? Also, with the extended patent term, you know, which is quite extensive, how are you perhaps thinking about doing additional clinical trials? Like, does it give you greater chance of, you know, or are you thinking about, you know, perhaps doing combination studies in addition after the RESCUE programs are done? Thanks.

[Sergio Traversa, CEO at Relmada Therapeutics]

Good afternoon, Uy Ear. Sergio here. I'll take the first one on the IP and then let Raj to handle the one on the development. Look, the we just filed a patent a few weeks ago, so allow me to be not too specific on what the claims are. In general, these are new patents and reflect the work that has been done in the U.S. in the formulation and manufacturing. These are new patent we filed in the U.S., and then we'll have the opportunity, we have some time, I believe it's one year, to file outside of the U.S. These are new patents, so they will provide coverage, if granted, of course, until sometime in 2047. I hope I kind of answer your question.

[Uy Ear, Analyst at Mizuho]

When do you expect the prosecution to end, or when do you expect the patent to be issued?

[Sergio Traversa, CEO at Relmada Therapeutics]

Yeah. It's always a guess. Look, we just filed, so from my experience, I would not expect anything, at least for the first 12 months, the first year. It looks like the patent office is very, very busy, with a lot of filing and applications, so I would not, I would not focus on any response before at least one year.

[Uy Ear, Analyst at Mizuho]

Okay.

[Raj Pruthi, CMO, Urology at Relmada Therapeutics]

Uy Ear, I can jump in on your other question about now we have the opportunities to look at NDV-01 in where else in lower track or upper track disease. I think there are a lot of opportunities, we can just follow the path of where has gemcitabine been effective. I think we started with BCG unresponsive and discussed that with those results. I think the extension into intermediate risk disease is a significant opportunity and market opportunity for Relmada. I think also another opportunity that we're considering is in the high-risk BCG naive population, another large patient population. I think on the heels of the BRIDGE study, which completed enrollment, I believe, in August 2025. It's an event-driven study, will take a couple years to read out.

[Raj Pruthi, CMO, Urology at Relmada Therapeutics]

I think that's also another place where we, you know, if BRIDGE does read out as gemcitabine is non-inferior to BCG and becomes an alternative, I think NDV-01 can nicely step in there as a, as an, yeah, easier-to-use, less burdensome approach for gemcitabine in the BCG naive high-risk population. Great question. Thank you.

[Uy Ear, Analyst at Mizuho]

Thanks.

[Sergio Traversa, CEO at Relmada Therapeutics]

Thank you, Uy Ear.

[Operator]

Thank you. Once again, for those who want to ask a question, please press star and one on your telephone keypad and wait for your name to be announced. Star and one if you wish to ask a question. The next question comes from Farzin Haque from Jefferies. Your line is now open. Please go ahead.

[Farzin Haque, Analyst at Jefferies]

Good afternoon. Thank you for taking my question. Following up on an earlier question, like you have a broad inclusion criteria for phase III, the BCG unresponsive setting, and you're allowing up to two prior lines, including a wide range, TAR-200, Anktiva, etc. How are you modeling the potential for variability or dilution of efficacy, and could you adjust to one prior line as the trial progresses?

[Sergio Traversa, CEO at Relmada Therapeutics]

Thank you, Farzin.

[Raj Pruthi, CMO, Urology at Relmada Therapeutics]

Yeah.

[Sergio Traversa, CEO at Relmada Therapeutics]

Raj, I think, would you mind to take this?

[Raj Pruthi, CMO, Urology at Relmada Therapeutics]

My pleasure. Thanks for the question, Farzin. It's a very thoughtful question. I think we've built in kind of guardrails to that study of up to two prior first-line therapies, with the idea that, you know, beyond that there may be some resistance mechanisms. We'll evaluate, we'll break that down by one or two lines of prior therapy. We're looking at that. Within the therapy too, another area we're looking at, and remember, these are open-label studies, so we can see how these patients are doing. We're also going to look at patients who've had prior intravesical chemotherapy as part of their BCG-unresponsive disease. Particularly Anktiva, we are excluding prior gemcitabine in those patients because we're giving a gemcitabine treatment.

[Raj Pruthi, CMO, Urology at Relmada Therapeutics]

We'll look at Anktiva and gemcitabine, and we have heard, and in my own practice, having gemcitabine as a rescue for gemcitabine is appropriate. I think we wanna see, you know, our efficacy is what is the our approach is what is the appropriate second-line therapy, right? These therapies are gonna be sequenced by urologists 2, 3, 4, 5x before cystectomy. Right now, there's a lot of agents approved and in development for the first-line. There's none in second-line therapy, that gives us an opportunity to provide the highest levels of evidence and a label for the second-line approach. From there, once urologists use it there, as we do, they could use it before or after.

[Raj Pruthi, CMO, Urology at Relmada Therapeutics]

That you bring up a good point. We are looking at lines of therapy and also what that prior therapy was. Thanks for the question, Farzin.

[Farzin Haque, Analyst at Jefferies]

Then on your phase III primary endpoint, does FDA's acceptance of CR at any time imply any durable responses, for example, median duration response greater than six months?

[Raj Pruthi, CMO, Urology at Relmada Therapeutics]

Their phrase was, they want the primary endpoint to be CR, and they also want to see duration of response. The words that they use is they want to look at the, quote, "totality of the data," close quote. I think they're getting at what you are, is a strong CR, which could be at three months, is great, but they want to see some level of durability in that. They didn't give the number on that, but they want to see some durability. CR, together with durability in this, framed as duration of response is what they'll want to see. Given the fact that there is no agents that have been approved in this space, I think they'll put all that together, as they said, in the totality of the data.

[Raj Pruthi, CMO, Urology at Relmada Therapeutics]

Really the other alternative for the patients at this point in their journey is radical cystectomy.

[Farzin Haque, Analyst at Jefferies]

Right. Makes sense. Then a quick one is that what is your expectation for enrollment cadence across both your pivotals? Can the drug's in-office profile serve as a recruitment advantage potentially?

[Raj Pruthi, CMO, Urology at Relmada Therapeutics]

Yeah, that's a great question, Farzeen. I think, and having been on a number of calls of our site qualification visits, the enthusiasm by investigators is significant. A lot of the sites participated to address cohort one, which is intermediate risk, have participated in PIVOT-006, and they're excited for the next intermediate risk study. We've modeled out up to 15-18 months, but with that enthusiasm and given what CG has been able to do as far as recruitment and number of events, I feel confident that we'll be able to meet or exceed that timeline. Regarding the second-line therapy, we are anticipating 12 months, but that's again, Farzeen, another area where there's incredible enthusiasm because urologists have nothing else at this point in their armamentarium to treat these patients.

[Raj Pruthi, CMO, Urology at Relmada Therapeutics]

A lot of these urologists, even the best in case scenarios, are 45% 12-month CR. You see 19%-45%, meaning 55%-80% of patients are recurring within one year with the first-line therapy. There's a large population of patients out there with BCG unresponsive CIS who failed first-line therapy. We're not competing with any other study. I'm optimistic that we'll be able to reach that 12-month enrollment.

[Farzin Haque, Analyst at Jefferies]

Great. Super helpful. Thank you, Rich.

[Raj Pruthi, CMO, Urology at Relmada Therapeutics]

Thanks, Farzin.

[Operator]

Thank you. There are no further questions that came through. This concludes our question and answer session and the call for today. Thank you, everyone. You may now disconnect.

Participants

Executives

• Maged Shenouda, CFO
• Raj Pruthi, CMO, Urology
• Sergio Traversa, CEO

Analysts

• Brian Ritchie, Managing Director at LifeSci Advisors
• Christopher Lui, Managing Director at Lucid Capital Markets
• Farzin Haque, Analyst at Jefferies
• Kelsey Gold, Analyst at Piper Sandler
• Uy Ear, Analyst at Mizuho