Good afternoon, and welcome to the Relmada Therapeutics Third Quarter 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 one. As a reminder, this conference call is being recorded and will be available for replay on the Relmada website. I would now like to turn the call over to Brian Ritchie from LifeSci Advisors. Please go ahead, Mr. Ritchie.
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 and nine months ended September 30th, 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 September 30th, 2026, filed after the close today.
This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast on November 12th, 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 today on today's call are Relmada CEO, Dr. Sergio Traversa, Dr. Bipin Dalmia, Relmada's Chief Business Officer, and Relmada CFO, Maged Shenouda. After the prepared remarks, we will open the call for a brief Q&A session. Now, I would like to hand the call over to Sergio Traversa. Sergio?
Thank you, Brian. Good afternoon, everyone, and welcome to the Relmada Third Quarter 2026 Conference Call. We have made significant progress with the NDV-01 program in the third quarter, and during today's call, I will provide the business overview, including an update on manufacturing. Bipin will review the 18-month Phase II results, which continue to demonstrate durability of response and a favorable safety profile, as well as the Phase III registrational program, now renamed SPECTRUM, to reflect NDV-01's potential across the full spectrum of non-muscle invasive bladder cancer, NMIBC. Maged will then review the third quarter financial results, and then I will come back to make a few concluding remarks. Let's start with NDV-01. NDV-01 is a novel sustained-release intravesical formulation that combines gemcitabine and docetaxel with the potential for quick and convenient administration in the urology office.
In the quarter, we have made significant progress in the manufacturing process, and we are on track to submit the IND by year-end 2026. The IND clearance will allow us to begin our registrational trials, marking an important step forward in the approval process for NDV-01. Beyond the IND filings, we have established a manufacturing plan to provide uninterrupted clinical supply through Phase III and support commercial readiness. Turning to sepranolone, our program for Prader-Willi syndrome, we are finalizing the stability testing of our prefilled syringe to enable IND submission, which is anticipated by year-end 2026. We expect to begin the Phase II proof-of-concept study upon IND clearance. We will now give Bipin the privilege to take through the 18-month data and the Phase III program for NDV-01. Bipin.
Thank you, Sergio, and good afternoon, everyone. For bladder-sparing therapies in non-muscle invasive bladder cancer, or NMIBC, patients and physicians are still forced to trade off efficacy, durability, tolerability, and convenience. We believe NDV-01 has the potential to deliver on all those dimensions simultaneously, and importantly, with a ready-to-use product that is designed for ease of market adoption and broad utilization. The data we are reporting today reinforce that view. Let me start with the initial 18-month Phase II results for NDV-01. In NMIBC, durability of response is a key question, and our long-term extension is where it gets answered. 23 high-risk NMIBC patients who are in complete response, or CR, at 12 months continued into a long-term extension study. Of the 14 evaluable patients at 18 months, 12, or 86%, remain in CR.
In the BCG unresponsive subgroup, seven of eight patients, or 88%, remain in CR at 18 months. Two patients progressed to muscle-invasive disease at month 15, one BCG-naive T1 patient and a second BCG-naive CIS with T1 patient. No patients in the study have undergone a radical cystectomy to date. We also updated our 12-month results, which now include 51 high-risk NMIBC patients. As the dataset has grown, the results have remained consistent, with anytime CR rate of 94% and a 12-month CR rate of 77%. In the BCG unresponsive subgroup, where the need for effective bladder-sparing options is the greatest, the anytime CR rate was 96% and the 12-month CR rate was 73%. Just as important, these efficacy results come with a consistently favorable safety and tolerability profile.
In the Phase II study to date, there have been no Grade 3 or higher treatment-related adverse events, no treatment-related serious adverse events, and no treatment-related discontinuations. Our market research shows that for a therapy designed for repeated in-office administration, including in the community setting where most patients are treated, such a clean safety and tolerability profile matters. Turning to our registrational Phase III program. As Sergio noted, we have renamed it SPECTRUM to reflect the potential breadth of NDV-01 across the entire NMIBC disease spectrum. Importantly, the program itself remains unchanged, with two FDA-aligned, independent registrational pathways. The first is a single-arm registrational study in second-line, high-risk BCG unresponsive NMIBC patients with carcinoma in situ, or CIS, with or without papillary disease. In addition, we have a separate exploratory cohort in second-line, high-risk BCG unresponsive papillary-only disease.
The second is a randomized study of NDV-01 as adjuvant therapy following TURBT versus observation in low-grade, intermediate-risk NMIBC, a setting with no approved therapies currently. To sum up, we believe the larger and more mature Phase II data continue to support NDV-01's potential to uniquely combine high and durable responses, a favorable safety and tolerability profile, with a simple in-office administration of a ready-to-use, sustained-release, biodegradable product, the combination physicians tell us they need. We look forward to initiating the Phase III SPECTRUM program upon IND clearance. With that, I will turn the call over to Maged. Maged?
Thanks, Bipin, and good afternoon, everyone. I'd like to build on Sergio and Bipin's comments by highlighting the substantial progress in manufacturing that should enable us to file the INDs for NDV-01 and sepranolone by year-end. We're also encouraged by the continued durability of response of the 18-month data that positions NDV-01 competitively and has the potential to make a meaningful difference in patient lives. I'll now walk you through our third quarter 2026 financial results.
Our press release and 10-Q filing provide the full details, including the nine-month results. Relmada closed the third quarter of 2026 with cash equivalents, and short-term investments of $202.1 million, compared to $93 million at December 31, 2025. Our current cash position is expected to fund company operations through 2029, including completion of the registrational Phase III NDV-01 SPECTRUM studies. Moving briefly through our third quarter financial results.
Research and development expense for the three months ended September 30, 2026, totaled $9.2 million, compared to $4 million for the three months ended September 30, 2025. The increase was primarily attributable to higher NDV-01 and sepranolone study preparation costs, increased manufacturing and drug storage costs, and higher employee compensation, partially offset by lower stock-based compensation. General and administrative expense for the same period totaled $3.9 million, compared to $6.3 million for the same period last year. The decrease was primarily driven by lower stock-based compensation and lower stock appreciation rights expense, partially offset by higher employee compensation and consulting services. Net cash used in operating activities for the three months ended September 30, 2026, totaled $12.6 million, compared to $6.7 million for the three months ended September 30, 2025.
The net loss for the quarter was $13.9 million, or $0.12 per basic and diluted share, compared with a net loss of $10.1 million, or $0.30 per basic and diluted share for the third quarter of 2025. Before we open the call for questions, I'll turn back to Sergio for some closing comments. Sergio?
Thank you, Maged. Before we open to the Q&A, I would like to summarize the significant process Relmada made in the third quarter with NDV-01 and sepranolone. We made important advancement with NDV-01 manufacturing, and we continue to expect to submit the IND for NDV-01 by year-end 2026 and initiate the P hase III SPECTRUM program upon IND clearance. The 18-month Phase II results provide further evidence of durable responses with NDV-01. We believe these findings strengthen NDV-01's potential to make a meaningful difference for patients with NMIBC. For sepranolone, we also continue to expect to file the IND by year-end 2026. Importantly, our cash resources are expected to fund operations through 2029, including the completion of the registration of Phase III SPECTRUM studies. I want to thank our team and the manufacturing partners for their dedication.
I am also grateful to the patients and investigators who made the NDV-01 Phase II study possible, and to our shareholders for their continued support. We look forward to keeping you updated as we work to bring NDV-01 and sepranolone closer to patients. Operator, we can now open to the call for questions.
Thank you. As a reminder, if you would like to ask a question, please press star one on your telephone keypad. Our first question comes from Kelsey Goodwin with Piper Sandler. Please go ahead.
Hey, guys. Congrats on the update. That is great to see. In terms of that dataset, maybe could you just remind us the split of CIS and papillary here? I know we get a lot of questions on this from investors, and maybe how to compare this dataset to competitors, given the CIS and papillary split. Then second, in terms of the IND for NDV-01, maybe just remind us what still needs to be done before we get that fully filed by the end of the year. Thanks so much.
Hi, Kelsey. Sergio here. I let Bipin to answer the CIS question, then maybe I'll take the manufacturing question. Bipin, would you mind?
Thank you, Sergio. Hi, Kelsey. We had a mix of CIS with pure CIS+Ta, and CIS with T1 patients. We look forward to sharing additional results as the dataset mature, and believe a future medical meeting may be a more appropriate forum to provide further details on the CIS subgroup.
Thank you, Bipin. Look, for the manufacturing, I wouldn't like to go too much in details because it gets very complicated, but we are writing the IND as we are speaking, and definitely planning to complete the all write-up and/or the filing before year-end. We are waiting for stability data. We have significant stability data already, and they look good. We have the two efforts, the U.S. effort with Piramal and the Israeli effort with Sinai, and so far, both set of stability data look good. We haven't decided how we will move forward, but I would say it's a nice problem to have, and it looks like we'll have both product that will meet the FDA requirement for the IND. So, it's a work in progress. Hope I answer your question.
Yeah, perfect. Thanks so much. Congrats again.
Thank you, Kelsey.
Your next question comes from Andres Maldonado with H.C. Wainwright. Please go ahead.
Hey, guys. Thanks for hosting this call, and thanks for taking my questions. Obviously, congrats on the progress. Couple quick ones from me. Just reading into the press release, the first one is, both patients who progressed to muscle-invasive disease, since they entered with T1 disease, the question is, were there earlier warning signs, and does that change how you would select or monitor for these T1 patients coming up? And if you can remind us, or if you can just give us a little bit more color on how many patients in the Phase II actually match the second-line SPECTRUM population, having failed another treatment after BCG, and kind of if you can give us additional color on what that efficacy in that subset looks like. Thank you.
Thank you, Andres. I believe Bipin can answer this question. Bipin?
Yeah. For the two patients who progressed, both of them were BCG-naive patients, as noted in the press release. The first patient was a T1 patient that received repeat TURBT before study entry, and was a responder through, I believe, nine months, no, through 12 months, and then continued into the study, and the recurrence with the T2a disease happened at 15 months. There were no early warning signs, to answer your question. And a very similar situation with patient number two. That patient was also a T1 patient with CIS at study entry, was a responder through 12 months, continued into the extension portion of the study, and then recurred once again with a T2a disease at 15 months. Importantly, these patients, after the 12-month CR, did not comply fully with their maintenance dosing between months 12 and 15. That could have been one factor.
We don't know. But that's the level of detail we have on those two patients.
Great. Thank you.
There was a second question too, Bipin.
I'm sorry, Andres, can you please remind me of the second question?
Sure, absolutely. Thanks again for circling back to it. The question is, just looking at how many patients actually match the second-line SPECTRUM population, having failed another treatment after BCG, what does efficacy look like in that subset for the phase II patients? Just trying to reconcile patient subsets to see if we can get a little bit of further detail on efficacy over time here that match the SPECTRUM population.
Thank you for the question, Andres. We have not conducted that analysis. I would like to note that the Phase II study is being conducted in Israel, where most of the first-line treatments were not available until very recently. I think one of the products has been launched very recently. The only thing they could have received other than BCG would have been off-label chemo, and we have not conducted that analysis yet.
Great. Thank you.
Your next question comes from Farzin Haque with Jefferies. Please go ahead.
Hi, everyone. Congrats on the progress, and thank you for taking my question. Just checking back on the CMC. Can you clarify if the issues have been completely resolved and you are simply waiting for the batch stability data, and if the early spec releases were all in line with your expectations? Then I have a follow-up.
Yeah, sure. Thank you. Thank you, Farzin. Well, I would not define that there was really some specific issue that needed to be resolved. As I mentioned in other calls, this one was not a technology transfer, so with the product manufacturing in another country or location and transferred to a different plant. This was the original product that is used in Phase II, is literally a prototype made in the pharmacy of the hospital and used in a very short amount of time.
It is sterilized with the autoclave that it is heating up the 120 degrees Celsius, the product. Clearly, that process of manufacturing is not suitable for scaling up and for an IND filing. So we had to recreate from the starting point a brand-new process and to manufacture exactly the same product. As you may imagine, manufacturing is a process that takes time.
So, we had at least one attempt to design a process that worked, but was not ideal. So we modified the process, and now we have two processes different to sterilize the product in place. All the steps have been optimized, and now the production is, we did GMP batches. It looks like, at least from the initial, and not really initial, I believe we have a nine weeks stability. It looks like it is well within the FDA requirement for the stability of the product. So, I hope I answered. There was no real particular issue that needed to be resolved. It was the process that needed to be optimized, and it looks like now is in the right direction.
Thank you for the color. Then for Bipin, maybe for Phase II, do you have the updated swimmer plot for all patients? How many of them required re-induction since the last cut?
Hello?
Yes.
Your line is open.
Yeah, Bipin.
Okay. Sorry. We've provided some re-induction information in our updated corporate deck. So in the overall population, we had six patients who were re-induced at three months in the overall population, and three of them converted from a non-CR at three months to a CR at six months. The study allowed for a re-induction at any time during the first 12 months. There were some additional re-inductions, and that data we will provide at a future medical congress. The more important point is, in our phase III going forward, we will allow re-induction only at the three-month time point, as agreed with the FDA.
Got it. Thank you so much.
Thank you, Farzin, and looking forward to see you next week.
As a reminder, if you would like to ask a question, please press star one on your telephone keypad. Your next question comes from Andrew Berens with Leerink. Please go ahead.
Hi, this is Troy on for Andy. Thanks for taking our question. With the IND filing-
Hi, Troy.
Hi. With the IND filing expected by year-end, how quickly do you think you can get from IND clearance to first patient dosed? Thanks.
Thanks, Troy, for the question. We run it quickly because we had several months where we enrolled the value sites, and they all, like, there's been significant process in the signing the contract, and clearly we need an IND clear before the IRB can actually approve the product. If you want to really give a number, I would say if the IND get cleared in a reasonable amount of time, that can be 30, 45 days, including the holidays in between, we should be able to enroll the first patient within the first quarter of next year.
Great. Thank you.
There are no further questions at this time. I would like to turn the call back over to Dr. Sergio Traversa for closing remarks.
Thank you, and a big thank you to everyone for the interest in our story, and looking forward for an update at the next conference call next quarter. Thank you very much.
Ladies and gentlemen, this concludes today's conference call. We thank you for your participation. You may now disconnect.