Good afternoon and welcome to the Ramada 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 1. As a reminder, this conference call is being recorded and will be available for replay on the Ramada 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, Realmada 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. Ramada'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 Ramada's press release issued today and the company's SEC filings, including the company's 10-Q filing for the quarter-ended September 30, 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 12, 2026. 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 today on today's call are Romada's CEO, Dr. Sergio Traversa, Dr. Bipin Dalmia, Romada's Chief Business Officer, and Romada's 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 RealMada Third Quarter 2026 conference call. We have made significant progress with the NWO1 program in the third quarter, and during today's call, I will provide a 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 3 registrational program, now renamed Spectrum, to reflect NDVO1's potential across the full spectrum of non-muscle invasive bladder cancer, NMIBC. Maged will then review the third quarter financial result, and then I will come back to make a few concluding remarks. Let's start with NDVO-1. NDVO-1 is a novel, sustain-release intravesical formulation that combines ZEN-cytokine and dosepaso 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 A&D clearance will allow us to begin our registrational trials, making, marking, and important steps forward in the approval process for any view. Beyond the A&D filings, we have established a manufacturing plan to provide uninterrupted clinical supply through Phase III and support commercial readiness. According to Cephronalon, our program for Trader-Williams Syndrome, we are finalizing the stability testing of our pre-field syringe to enable IND suppression, which is anticipated by your end 2026. And we expect to begin the Phase II proof-of-concept study upon IND clearance. We now give Bipin the privilege to take through the 18-month data and the Phase III program for NDVO-1.

Bipin. Thank you, Sergio, and good afternoon, everyone. For bladder sparing therapies in non-muscle invasive bladder cancer, or in MIBC, patients and physicians are still forced to trade off efficacy, durability, tolerability, and convenience. We believe NDVO-1 has the potential to deliver on all those dimensions, The data we are reporting today reinforce that need. Let me start with the initial 18-month Phase II results for NDVI-1. 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 to do a long-term extension study. Of the 14 evaluable patients at 18 months, 12 or 86% remain in CR. Bipin Dalmia and a second BCG naive CIS with T1 patients. No patients in the study have undergone a radical cystectomy to date. We also updated our 12-month results, which now includes 51 high-risk NMIPC patients. The data sets have shown the results have remained consistent with any time CR rate of 94% and a 12-month CR rate of 77% in the BTGN responsive subgroup, but the need for effective plant spraying options is greater. The any time CR rate was 96%. In the case to study today, there have been no rate 3 or higher treatment-related adverse Our market research shows that for a therapy designed for repeated inoperative intubation, including in the community setting where most patients are treated, such a clean safety ensures quality of life. Turning to our registration-based research, as Sergio noted, we have renamed its structure to reflect the potential threat of NBVO1 across the entire Importantly, the program itself remains unchanged, with two FDA lines, independent, that is, is a single-arm registration study in second-line, high-risk, BCGN-responsive NMIVC patients with carcinoma in situ or CIS with or without papillary disease. In addition, we have a separate Explorer Glory cohort in second-line, high-risk, BCGN-responsive, papillary-only patients. The second is a randomized study of NMIVC. as the actual therapy following QRPD versus observation in low-grade intermediate-rest NMID, a study with no approved therapy score data. The larger and more mature Phase II data continue to support NDVO-1's potential to uniquely combine high endurable responses, a favorable safety and tolerability profile, with a simple and accurate administration of a ready-to-use, sustained release by degradable products. The combination positions tell us that

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 IMDs for NDVO1 and superanilone by year-end. We're also encouraged by the continued durability of response to the instrument data that physicians and for our third quarter 2026 financial results. provide the full details, including my own results. Dalmada closed the third quarter of 2025 with cash, cash for a short-term investment of $202.1 million, compared to $93 million at December 31, 2025. Our current cash division is expected to fund company operations through 2029, including substitution of the registration Research and Development Expense for the three months into September 30, 2026 totaled $9.2 million compared to $4 million for the three months into September 30, 2025. The increase was primarily attributable to higher NDVA-1 and Cranolone study preparation costs, increased manufacturing and drug storage costs, and higher employee compensation, partially offset by lower stock and compensation. Thank you for joining us. Thank you for joining us.

Thank you, Maged. Before we open to the Q&A, I would like to summarize the significant process RealMada made in the third quarter with NDVO-1 and SEPRANO. We made important advancement with NDVO-1 manufacturing and we continue to expect to submit the IND for NDVO-1 by year-end 2026 and initiate the Phase III spectrum program upon IND clearance. The 18-month phase 2 results provide further evidence of durable responses with NDVO1. We believe this finding strengthens NDVO1's potential to make a meaningful difference for patients with NMIBC. For Sopranolone, 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'm also grateful to the patients and investigators who made the NDBO-1 Phase III study possible and to our shareholders for their continuous support. We look forward to keeping you updated as we work to bring NDVO-1 and Cepranolone 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 1 on your telephone keypad. Our first question comes from Kelsey Goodwin with Piper Sandler. Please go ahead.

Hey, guys. Congrats on the update. That's great. Great to see. In terms of that data set, 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 data set to competitors, you know, given the CIS and papillary split. And then... Hi, Kelsey and Sergio here. I'll let Bipin to answer the CIS question and maybe I'll take the manufacturing question. Bipin, would you mind?

Yeah, thank you Sergio. Hi Kelsey. We had a mix of CIS with pure CIS, CIS-PA and CIS with T1 patients. We look forward to sharing additional results as the data set matures and I believe a future medical meeting may be a more appropriate forum to provide further details on the CIS.

Thank you, Bipin. And 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 We have significant stability data already and they look good. We have the two efforts, the U.S. effort with Pyramal 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 products that will meet the FDA requirement for the IND. So it's a work in progress. Hope I answered your question.

Yeah, perfect. Thanks so much. Congrats again.

Thank you, Kelsey.

Your next question comes from Andres Maldonado with HC Wainwright. Please go ahead.

Hey, guys. Thanks for hosting this call and answering my questions. Obviously, congrats on the progress. A couple quick ones from me. Just reading into the test release, the first one is, you know, both patients who progressed to muscle invasive disease, you know, since they entered the T1 disease, The question is, you know, were there earlier warning signs, and does that change how you would select and 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 the patients you actually match the second-line spectrum population, you know, having failed another treatment after BCG, and kind of give us additional color on what that has to see Thank you, Raj.

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 ended and was a responder who, I believe, through 12 months and then continued into the study and the recurrence with the T2A disease happened at 15 months. So there were no early warning signs to answer the question. And kind of 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 through into the extension portion of the study, and then recurred once again with the T2A disease at 15 months. Importantly, these patients after the 12-month CR did not comply fully with their There was a second question. I'm sorry, Andrew, can you please remind me of the second question?

Thanks again for circling back to it.

Thank you for the question. So we have not conducted that analysis. I would like to note that the phase two study is being conducted in Israel where Most of the first-line treatments were not available until very recently. I think one of the doctors was lost very recently. So the only thing they could have achieved other than BCG would have been off-label chemo, and we have not conducted that yet.

Your next question comes from Farzin Haque with Jeff Rees. Please go ahead.

Hi, everyone. Congrats on the progress, and thank you for taking my question. Just to get back on the CNC, can you clarify if the issues have been completely resolved?

Yeah, sure. Thank you. Thank you for asking. 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 transfer to a different plant. This was the original product that was used in Phase 2. It's literally a prototype made in the pharmacy of the hospital and used in a very short amount of time. And it's sterilized with autoclave that it's heating up. The 120 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. And as you may imagine, manufacturing is... Thank you for joining us. The process and now we have two processes different to sterilize the product in place and all the steps have been optimized and now the production is GMP batches and it looks like at least from the Initial, not really initial, I believe we have about nine weeks, but it looks like it's well within the FDA requirements, the stability of the product. So, nobody answered, right? There was no real particular issue that needed to be resolved, but the process needed to be optimized, and it looks like now it's in the right direction.

Okay, so we've provided some induction information in order to appropriate that in the overall population. We have six patients who were induced at three months in the overall population and three of them converted from a non-CR at three months to a CR and the study allowed for a re-induction at any time during the first 12 months. So there was some additional re-induction and that data we can provide at a future medical conference. But the more important point is, in our case, going forward, we will allow re-induction only at the beginning of the year.

Hi, this is Troy on for Andy.

Thanks for taking our question. With the IND filing expected by year end, how quickly do you think you can get some IND clearance to first patient dose?

Thanks, Troy, for the question. We ran it quickly because we had several months where we involved the value side and they are all like significant properties. They signed the contract and clearly we need an AMD clear before the IRB can actually approve the product. But we want to really... Great, thank you. Thank you and a big thank you to everyone for the interest in our story and looking forward for an update at the next presentation.