Relmada Therapeutics, Inc.

Good afternoon, and welcome to the Roll Mata Therapeutics second quarter 2025 earnings conference call. At this time, all participants are in a listen-only mode. After the prepared remarks, we will conduct a question and answer session. To ask a question, please press star 1. As a reminder, this conference call is being recorded and will be available for replay on the Roll Mata website. I would now like to turn the call over to Brian Ritchie from LifeSci Advisors. Please go ahead, Mr. Ritchie.

Thank you. Good day, everyone, and thank you for joining us today. This afternoon, Ramada issued a press release providing a business update and outlining its financial results for the three months ended June 30, 2025. 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, Ramada'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 Ramada's press release issued today and the company's SEC filings, including in the annual report on forms 10K, excuse me, in the quarterly report on Form 10Q for the quarter ended June 30th, 2025, 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 on August 7th, 2025. Realmada 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 Roamata's CEO, Dr. Sergio Traversa, who will briefly provide a summary of recent business highlights, Dr. Raj Pruthi, Roamata's CMO, who will provide an overview of NDB01, and Roamata's CFO, Megan Chinowda, who will provide an update on the separate loan and a review of the company's Q2 financial results. After that, we will open the call for a brief Q&A session. Now, I would like to turn the call over to Sergio Traversa.

Sergio?

Thank you, Brian. Good afternoon and welcome everyone to the Real Mada Second Quarter 2025 Conference Call. During today's call, I will provide an overview of our recent progress and upcoming milestones. After that, Raj Pruthi will review the updated six-month Phase 2 data for NDV01 that we announced today. Magad will provide an update on Sopranolon and review our financial results. Then we'll make a few closing remarks and we'll take your questions. Raman is making good progress this year. To get started, I would like to highlight four points. We are excited about the two product candidates that we added to the company, NDVO1 for non-muscle invasive bladder cancer, or NMIBC, and Cepranolone for compulsivity disorders, starting with Prader-Willi syndrome, or PWS. NDVO1 and Cepranolone are well aligned with our product acquisition criteria. They have demonstrated proof-of-concept data and good overall safety in their initial studies, and they have the potential to be first-in-class programs. In addition, they each address significant and underserved markets with potential to expand beyond the first indication. Second, we are pleased to report that the six-month follow-up from the Phase II study of NDB01 produced impressive response rates. with 91% of patients achieving high-grade disease-free status at any time point following NDVO1 treatment. As a reminder, NDVO1 is a sustained release formulation of gencytabine and doxetaxel, or gem dosing. Third, we have expanded our team with the addition of two highly respected experts in bladder cancer and urologic oncology. Dr. Raj Pruthi as Chief Medical Officer, Oncology, and Dr. Jay Lothan as Chair of our Clinical Advisory Board. We believe their contribution will be instrumental to our success. And fourth, we have made significant progress toward our objective of bringing each program to patients as soon as possible, with preparation underway to begin the next set of studies for NDBO1 and Cepranolone in 2026. With two promising product candidates, an extended management team, and clinical advisory board, a $20.6 million cash balance, and a clean balance sheet, I believe Ramada is well-positioned to take the next value-creating steps for each program. Next, I would like to ask Dr. Pruthi to update you on NDVO-1 and the new six-month follow-up data. Raj? He's an accomplished urology expert with vast clinical experience in the development of novel therapy for non-muscle invasive bladder cancer. Raj, how are you?

Thank you, Sergio, and good afternoon, everyone.

I'm excited to be part of the ROMADA team. This afternoon, I'm pleased to provide a brief overview of NDV-01 and share the positive six-month follow-up data from our Phase II open-label study in patients with high-grade non-muscle-invasive bladder cancer. There are about 85,000 new cases of bladder cancer diagnosed each year in the United States, and 600,000 people in the U.S. living with bladder cancer. About 50% of new cases of bladder cancer have high-grade disease, that is, a high risk of recurrence and potentially progression. I joined Ramada because I believe that NDV-01 has the unique potential to become a class-leading bladder sparing therapy for NMIVC. This is an exciting time for our patients. NDV-01 is a novel, sustained-release, intravesical formulation of two chemotherapy agents, gemcitabine and docetaxel, or gemdose, as we say. It was designed to build on data from over the past decade from academic centers showing that combination use of these two agents achieved response rates and recurrence-free survival that were comparable to or better than the historical standard of care, BCG. And for those who are unresponsive to BCG, it can provide an effective second-line option to avoid susceptibility. The sustained release formulation of NDV-01 is intended to accomplish four objectives. First, prolonged bladder exposure to gem dosing. Second, to minimize systemic toxicity. Third, to overcome cumbersome handling and preparation. And fourth, to simplify administration, decreasing the burden to patients and providers. NDV-01 is provided to study sites in a ready-to-use dose that can be administered in the office in less than 10 minutes without the need for a specialized pharmacy, biocontainment hood, or newer dedicated equipment. Moving to the Phase II study, NDV-01 is being evaluated in a single-arm, single-center XUS clinical trial in patients with high-risk NMIBCs. Patients are treated with NDV-01 in a bi-weekly induction phase, followed by a monthly maintenance for up to one year, with regular assessments done with cystoscopy, cytology, and, if needed, biopsy. The Phase II study was designed to enroll up to 70 subjects with localized non-metastatic high-risk NMIBCs. The primary endpoints are safety and complete response, or CRR, at 12 months. Secondary efficacy endpoints are duration of response and event-free survival. Efficacy assessments for the six-month follow-up included analysis of the data at six months and at any time point. These are the same safety and efficacy parameters that were applied to the three-month data that were presented at the American Neural Object Association meeting in April. For the six-month efficacy assessment, we observed a complete response rate of 90% based on 21 patients at six months. Looking at the data at any time point, we observed a complete response rate of 91% for 23 patients at any time. Of patients with BCG unresponsive disease, we see an 88% CR any time. And in carcinoma in situ or CIS patients, we see 100% CR any time. The assessment of disease-free status at six months showed that, again, 90% of the 21 evaluable patients achieved disease-free status at the six-month assessment. This is based on the 29 patients enrolled, which include seven with concomitant CIS, 22 with papillary disease, that is TA or T1. In the study, five of these patients have been re-induced, four at three months, and one at six months. NDV-01 continues to demonstrate favorable safety. At the six-month follow-up, there were no treatment-related adverse events greater than grade three. The most common treatment-related adverse events were urinary dysuria, and hematuria, with hematuria only seen in 4% of the patients. The majority of the patients with dysuria were grade 1 and resolved within 24 hours. No patients had treatment discontinuations related to adverse events. These durable six-month follow-up data are consistent with our expectations and with the known efficacy of GEM doses. The results reported today raise our confidence in the potential for NDB-01 as a promising, effective, safe, and durable treatment for non-muscle invasive bladder cancer. Our goal is to bring NDB-01 to patients as soon as possible. We intend to initiate a phase three study for NDB-01 in the first half of 2026. Our efforts in the coming months will be focused on completing study preparations, including plans to interact with the Food and Drug Administration on our proposed trial design, and transfer production to a contract manufacturer to complete scale-up and production of clinical batches. Now, I'd like to turn the call over to our Chief Financial Officer, Magid Shenouda, to talk more about Soprano Loan and our financial results. Magid?

Thank you, Raj. I'll spend a few minutes on Sopranolone and then provide you with an overview of our second quarter financial results. Sopranolone is a member of a new subgroup of neurosteroids called GAMSAs, or GABA-modulating steroid antagonists. We believe Sopranolone's novel action on the GABA neurotransmitter pathway gives it unique potential to alleviate the repetitive symptoms and disorders where compulsive behaviors are a common feature. These disorders affect millions of people in the U.S. and around the world and include indications such as Prader-Willi syndrome and Tourette syndrome. We have selected Prader-Willi syndrome, or PWS, as the first clinical indication that we will evaluate with Sopranolol. It affects approximately 350,000 people worldwide, including approximately 20,000 people in the U.S. PWS is a complex genetic disorder, often defined by persistent hunger and overeating. Current treatment is focused on improving the obsessive-compulsive behaviors and other medical complications that characterize this disorder. Phase II data from a study in patients with Tourette syndrome provided proof of concept for sopranolone's mechanism of action in compulsivity disorders and demonstrated that the compound has good overall tolerability. We intend to initiate a proof-of-concept study in PWS in the first half of 2026. Our efforts in the coming months will be focused on completing study preparations, including plans to interact with the FDA on our proposed trial design, and setting up our product supply chain, including contract manufacturing. Moving now to our financials. We believe our discipline development strategy and two promising innovative product candidates have significantly enhanced RealModest pipeline and long-term value proposition. We think we are poised to make excellent progress in our upcoming milestones through the end of this year and beyond. As noted by Brian, this afternoon we issued a press release announcing our business and financial results for the second quarter into June 30, 2025. As of June 30, 2025, Elmada had cash, cash equivalents, and short-term investments of approximately $20.6 million, compared to $44.9 million as of December 31, 2024. Cash used in operations in the second quarter into June 30, 2025 was $6.4 million, compared to $13.3 million for the same period in 2024. Looking ahead, we're prioritizing the advancement of NDV01. As we advance our clinical and regulatory strategy for each program, we expect to have a line of sight to our cash requirements and runway. During today's call, I will review the second quarter 2025 financial results. Information regarding the six-month results are included in our press release and 10Q issued this afternoon. Research and development expense for the second quarter of 2025 totaled $2.8 million, compared to $10.7 million for the second quarter of 2024, a decrease of $7.9 million. The lower spend was primarily driven by lower study costs, with a wind-down of clinical trials for REL 1017 partially offset by an increase in costs associated with a ramp-up of NDVO1 and soprano loan activities, and an increase in R&D employee compensation. General and administrative expense for the second quarter of 2025 totaled $7.4 million, compared to $8.1 million for the second quarter of 2024, a decrease of approximately $696,000. The decrease was primarily driven by a decrease in stock-based compensation expense partially offset by an increase in employee and consulting service costs. The net loss for the second quarter of 2025 was $9.9 million, or 30 cents per basic and diluted share, compared with a net loss of $17.8 million, or 59 cents per basic and diluted share, for the second quarter of 2024. Before we open the call for questions, I will turn back to Sergio for some closing comments. Sergio?

Thank you, Maggie. I'd like to leave you with these key messages from today's call. 2025 is off to a strong start for Almada. First, we are excited about our innovative new programs, NDBO1 for non-muscle-invasive bladder cancer, or NMIBC, and Sopranolol for compulsivity disorders. They are well aligned with our strategic objectives. And second, We are pleased to report that the six months follow up from the phase two study of NDV01 produced impressive response rate with 91% of high risk patients achieving disease free status at any time point following NDV01 treatment. Third, we have expanded our team with the addition of two highly respected experts in bladder cancer and urologic oncology. Dr. Raj Pruthi, Chief Medical Officer, Oncology, and Dr. Yair Lotan as chair of clinical advisory board. We believe that their contribution will be instrumental to our success. And fourth, we are preparing to begin a phase three study for NDBO1 in the first half of 2026. In addition, we expect to initiate a phase two study with sopranoid in Prader-Willi syndrome also in 2026. With two promising product candidates, an expanded management team and clinical advisory board, 20.6 million in cash balance, and a clean balance sheet, we believe RealMod is well positioned to take the next value-creating steps for each program. With our progress comes our gratitude for your support and for taking time to join the call today. We look forward to updating you on our continued progress throughout the year. Operator, I would now like to open the call for discussion, for questions.

Thank you. Ladies and gentlemen, as a reminder, if you would like to ask a question, please press star 1 on your telephone keypad at this time. Our first question is coming from the line of Oiir with Mizuho Securities. Please proceed with your question.

Hey, guys. Yeah, congrats on the six-month data. It looks very, very encouraging. So... maybe just help us understand, you know, with the data at hand and also the recent approval that Urogen got for their product. Just help us out, you know, how do these factors, these events factor into your thinkings with respect to NDV01 going forward? Are you more focused on high grade or you're moving sort of away from that to maybe a larger market and less competitive market in non-I grade, non-invasive bladder cancer. So that's the first question. And the second question is, I guess, when you are meeting with the FDA, maybe they're related, what are you hoping to accomplish there and what sort of data will you present? I'll just stay with these two questions for now. Thanks.

Sergio here. Thank you all for the questions. I believe Raj is the right person to answer your questions. Raj? Yes. Thank you.

And I think your first question is, you know, what is the best approach? Is it high risk, which I shared with you, the very exciting data? or is it a Eurogen type of approach with low-grade intermediate risk? I think was the question. And I'll address that first. I think the second was regarding the FDA. I think you bring up a great question as far as the go-forward strategy. I think you outlined it perfectly, that there's a great opportunity in low-grade intermediate risk. The incident and prevalent population is very large. These are patients who don't just develop new tumors each year but they recur, they recur at about a rate of 50%, so the prevalent population increases and the burden of TURB3 or transurethral resection of bladder tumor is what the patient bears. I think UroGEN with their approval earlier this year set an excellent precedent of a single arm open label study in this space getting approval. And this will lead into a conversation FDA. So I think that is an excellent opportunity for any chemo ablative agent. And I think we're seeing chemo ablation become a much more in replacing TRBT, which there are about 100,000 performed each year, become a much more attractive alternatives for clinicians and desired by patients. So I think that is an excellent opportunity. However, with the data we share with you, the efficacy in high-grade disease is also significant and one that will continue to generate clinical evidence for urologists to have in hand and perhaps for guidelines inclusion. The FDA pathway for that is also clear. That is what TAR200 or Edstiladrine with Bering or Antiva, Keytruda, others are pursuing in CG or have achieved. It's a tougher group of patients. It's a smaller group of patients. And it's a little bit tougher to enroll because these are often BCG unresponsive with CIS. So again, much smaller patient population. But I think we have the clinical data to show that we're effective in high-risk disease. So I think there's two opportunities that you outlined, both which fit very well with NDV-01. Your second question is, what will we ask the FDA? I think one of the main questions will be, a conversation of, you know, is the urogen path that there's precedent for, which they did earlier this year, a viable path for us forward for a single-arm open-label study in chemoablation? That'll be our main question with them. I hope I addressed your question.

Yes, and maybe I can ask a follow-up if it's possible. So if you have to sort of look between, you know, the data that you have in hand and which is in high grade and what you would like to move in or, you know, potentially a better opportunity, which is the low to intermediate grade, where do you sort of see more risks? Maybe just help us understand, like, what would give you confidence to move into the low to intermediate grade?

Great question. I think that conversation with the FDA will be very important to do that. I think another attractive, why that's another attractive option is I think we think that that is a faster opportunity to FDA approval. I think you accrue to those trials much more rapidly in the low-grade intermediate patients. There's much more of them, so I think that's a faster path to FDA approval and to get this into urologist's hands. The risk comes in, we have one study before, and that's with Urogen. The positive of that is it was approved and it was this year.

I think the FDA will help us make that decision.

Okay. Another question, if I may. You know, how should we kind of sort of think about R&D going forward? You know, the R&D has dropped meaningfully. Understandably, I guess you're trying to conserve cash to prioritize NDV01.

Yeah, maybe I should answer that. Well, the R&D expense went down because we are not enrolling patients. The big cost of R&D is enrolling patients. And we're planning to do that as soon as we start both the phase two in Sopranolone and the phase three in NDVO1 in the first half of next year. So until then, the cost is reduced because it's manufacturing. getting ready, dialogue with the FDA that these are not expensive activities. Don't think that because the cost of R&D went down, the activity also slowed down. We have well enough resources, financial, to do what is needed to do now. And, you know, the expense will go up when we start to enroll patients.

Okay. Thank you.

Thank you, Oye.

Thank you. Ladies and gentlemen, this does conclude our question and answer session and our call for today. We thank you for your participation and you may disconnect your lines at this time.