Relmada Therapeutics, Inc. Common Stock 2026 Q2 Earnings Call

Good day, everyone. 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 and six months ended June 30, 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. Relmada's management team will be making forward-looking statements during this call. 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 the company's 10-Q filing for the quarter ended June 30, 2026, 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 6, 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 Chief Executive Officer, Sergio Traversa, who will provide a business update. Bipin Dalmia, Relmada's Chief Business Officer, will offer his perspective on NDV-01 and the non-muscle invasive bladder cancer landscape. Relmada's Chief Financial Officer, Maged Shenouda, will review the second quarter 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? Thank you, Joyce. Good afternoon, everyone.

Welcome to the Relmada second quarter 2026 conference call. Relmada has entered a critical execution phase. We have a strong balance sheet, an experienced and strengthened leadership team, and a clear plan to move NDV-01 into registrational development. I would like to use this time today to tell you where we stand and why we are confident in the path ahead. Let me start with a brief recap. NDV-01 is a novel, sustained-release, intravesical formulation of gemcitabine and docetaxel, or Gem/Doce, that builds on the well-established safety and efficacy profile of conventional Gem/Doce. We believe NDV-01 has the potential to be a best-in-class therapy for patients with non-muscle invasive bladder cancer, or NMIBC, a disease affecting more than 744,000 people in the U.S. alone. Our clinical and regulatory foundation is strong. The 12 months phase II data are compelling.

95% of patients achieved a complete response at any time, 76% had a durable complete response at 12 months, and safety has been favorable throughout. We have FDA alignment on the two planned registrational pathways. We continue to see strong interest from the uro-oncology community. Let me go directly to manufacturing because it is our immediate priority. NDV-01 is a novel sustained-release therapy that combines two chemotherapies in a single delivery system. Manufacturing a product like this to scalable and registrational standards is demanding work. It requires a specialized capability, coordination across several supply chain partners, and scale-up from a laboratory prototype to a full good manufacturing practice, or GMP, production. We have done the work to understand what that requires. We also have planned the remaining activities needed to support the IND. We are executing against a clear plan to complete them.

This is work driven to quality, and we are dedicated to getting it done right. Importantly, all the components around manufacturing are ready. We have FDA alignment, a robust data set, and clinical trial sites that are engaged and prepared to begin enrolling patients as soon as the IND is cleared and clinical material is available. Manufacturing is the final piece, and we are confident in our plan and in our team. We plan to file the IND NDV-01 by year-end of 2026 and to initiate the Phase III rescue registrational program upon IND clearance. The same discipline applies to sepranolone, our program in Prader-Willi syndrome, or PWS, a rare and underserved condition estimated to affect 350,000 to 400,000 people worldwide. Here, the formulation development is complete, and the one remaining step is finalizing the prefilled syringe delivery system.

We expect to file the sepranolone IND by year-end 2026 as well, and to initiate phase II proof of concept study upon an IND clearance. On both programs, we have characterized what is required, we have a clear plan in place, and we are executing on it. Before we turn to our financial results, I would like to have the privilege to introduce Bipin Dalmia, our new Chief Business Officer. Bipin joined us this quarter and brings nearly 3 decades of experience in uro-oncology, business development, and manufacturing oversight, including leading the U.S. launch of the first FDA-approved intravesical gene therapy for NMIBC. Bipin also brings strong industry relationship and an outstanding track record of value creation. Bipin, it's all on you.

Thank you, Sergio. Good afternoon, everyone. As Sergio mentioned, I've spent nearly 3 decades in biopharmaceuticals, including many years focused on uro-oncology, and especially non-muscle invasive bladder cancer, or NMIBC. During my first two weeks with the company, I've spent considerable time reviewing NDV-01's clinical, regulatory, and manufacturing plans, as well as our patent strategy. That work has only strengthened my belief that NDV-01 represents one of the most compelling opportunities in NMIBC. Let me explain why. The NMIBC treatment landscape is evolving rapidly, particularly in BCG-unresponsive disease, where bladder preservation is increasingly the primary goal of treatment. Yet patients and physicians are still forced to make important trade-offs. The newer therapies available today may deliver on one dimension, either efficacy or durability or convenience, but in each case, at the expense of another important dimension.

Our market research and KOL discussions suggest that what physicians and patients continue to need is an intravesical therapy that delivers meaningful efficacy and durable responses without compromising safety, tolerability, convenience, or ease of use. These trade-offs will become even more important as the market moves into the community setting, where majority of the patients are, and into earlier stages of NMIBC, such as intermediate risk and BCG-naive settings. That is where we believe NDV-01 has the potential to differentiate itself. What I find particularly compelling about NDV-01 is that we're building on a strong clinical foundation rather than starting from scratch. We're leveraging decades of published clinical experience with gemcitabine and docetaxel, a combination that is deeply familiar to the urology community.

Our innovation is not in changing those therapies, but in finding a better way to deliver them through a sustained-release formulation that combines prolonged bladder exposure without the use of a physical device, with a simple office-based procedure that can be completed in approximately five minutes. In summary, the combination of a well-established therapeutic foundation, encouraging efficacy and durability results from our phase II study, favorable safety and tolerability, practical ease of use, and applicability across most NMIBC patient populations differentiates NDV-01 from many current and emerging approaches in the field, combined with a clear FDA-agreed regulatory path and strong patent protection. Taken together, these attributes support our belief that NDV-01, if approved, has the potential to become a foundational and best-in-class intravesical therapy across the NMIBC disease spectrum. I joined Relmada because I believe in that potential and in this team's ability to execute.

While important work remains ahead, the path forward is well-defined. We have an experienced team and strong external partners focused on executing against a clear plan and well-defined near-term milestones. I'm excited to be part of Relmada at this important stage and look forward to helping advance NDV-01 for patients who need new treatment options. With that, I'll turn the call over to Maged.

Maged? Thank you, Bipin, and good afternoon, everyone.

I'll walk you through our second quarter 2026 financial results. Our press release and 10-Q filings provide the full details. Relmada closed the second quarter of 2026 with cash equivalents, and short-term investments of $217.7 million, compared to $93 million on December 31, 2025. Our current cash resources are expected to fund company operations through 2029, including completion of the phase III rescue program for NDV-01. Moving briefly through our second quarter financial results. Research and development expense for the three months ended June 30, 2026, totaled $8.4 million, compared to $2.8 million for the three months ended June 30, 2025. The increase was primarily attributable to higher NDV-01 and sepranolone study costs and increased manufacturing and drug storage costs, partially offset by lower employee compensation.