Good day, everyone, and thank you for joining us today. This afternoon, Romada issued a press release providing a business update and outlining its financial results for the three months ended September 30th, 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, Romada'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 Romada's press release issued today and the company's SEC filings, including in the annual report on Form 10-Q for the quarter ended September 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 November 13th, 2025. Romada 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 Romada CEO Dr. Sergio Traversa, who will briefly provide a summary of recent business highlights, Dr.

Raj Pruthi, Romada's CMO, who will provide an NDB-01 program update, and Romada CFO Maged Shenouda, who will provide an update on sepranolone and a review of the company's Q3 financial results. After that, we will open the line for a brief Q&A session.

Now, I would like to hand the call over to Sergio. Sergio, please go ahead.

Thank you, Brian, as always. Good afternoon and welcome, everyone, to the Romada Third Quarter 2025 Conference Call.

2025 is shaping up to be a standout year for Romada, with excellent product development progress driven by the effort of our outstanding team and strengthened by our recent successful capital raise. We are developing one late-stage and one mid-stage clinical program that we believe could be life-changing for patients.

Each program has the potential to be the best-in-class treatment. Our lead program is NDB-01, a sustained-release formulation of gemcitabine docetaxel, or Gem/Doce, in development for non-muscle-invasive bladder cancer, or NMIBC, which affects about 60- 68,000 new patients each year in the US and has a prevalence of approximately 744,000 patients in the US only.

Our second program is sepranolone, that is intended to normalize GABAA receptor activity in compulsive disorder. Sepranolone is in development for Prader-Willi syndrome, which has a US prevalence of approximately 20,000 patients.

Here are the three key messages that we will cover today. Number one, we report the nine months follow-up data from the Phase 2 study of NDB-01 in patients with NMIBC.

In brief, the study showed a 92% overall response rate at any time, with favorable overall safety. We are very pleased by these encouraging and consistent data.

Number two, we are pleased to have secured FDA alignment on the key elements of the Phase 3 program for NDB-01 that is intended to enable two distinct and independent registrational tracks for NDB-01 in NMIBC. This is an important key derisking milestones for the program that opens the door to a broad market opportunity in NMIBC.

Number three, with the recently completed $100 million underwritten financing, we are well-capitalized. The recent offering provides the resources to support our planned operations into 2028 and drive forward the planned registration studies for NDB-01 and the Phase 2 study for sepranolone in PWS.

We are preparing to initiate these studies in 2026. For NDB-01, we expect to begin two separate registrational studies for NMIBC start in the first half of 2026.

For sepranolone, we anticipate starting a Phase 2 study in PWS, also in the first half of 2026. We are well-positioned to advance our pipeline thanks to our expanding clinical team.

Earlier this year, we appointed Dr. Raj Pruthi as Chief Medical Officer, Uro-Oncology.

Dr. Pruthi is a highly respected expert in bladder cancer and urologic oncology who brings vast experience advancing novel therapies for NMIBC.

We have also established a Clinical Advisory Board to provide additional guidance for the pivotal program for NDB-01. The board is comprised of prominent leaders in NMIBC and chaired by Dr.

Yair Lotan, a renowned urologic oncologist. In October, we were pleased to welcome Dr.

Max Kates to our Clinical Advisory Board. Dr.

Kates bring a wealth of experience from chairing the landmark Phase 3 BRIDGE study and leading several other practice-changing studies. I am very pleased with Romada work this year to derisk our pipeline and advance two potentially life-changing therapies.

We are looking ahead to 2026 with enthusiasm, with several value-inflection catalysts ahead. Next, Raj is going to provide an update on the NDB-01 development program, including the nine months follow-up data from the Phase 2 and a summary of the key highlights from the recent type B pre-IND meeting with the FDA.

Raj?

Thank you, Sergio, and good afternoon, everyone. I believe this is a very exciting time for our patients based on our excellent progress with the NDB-01 development program.

I want to touch on three items today: an overview of the patient care journey in non-muscle-invasive bladder cancer, or NMIBC; a review of the nine-month data; and a summary of the FDA meeting highlights. Let's start with the NMIBC and the patient journey.

There are about 85,000 new cases of bladder cancer diagnosed each year in the United States and 744,000 people living with bladder cancer. About 80% of bladder cancer patients have NMIBC, and recurrence rates over five years are about 60% to 80%.

Romada is focused on high-risk NMIBC and on intermediate-risk NMIBC, representing about 80% of NMIBC cases, or 54,000 people per year. In brief, the patient care journey most commonly begins when a patient presents with blood in the urine, or hematuria.

Suspected bladder cancer cases are diagnosed using cystoscopy and cytology. Treatment begins with a surgical procedure called transurethral resection of the bladder tumor, or TURBT.

This procedure allows surgeons to classify the patient's disease stage and risk category and define the treatment plan. After surgery, patients with high-risk disease receive intravesical adjuvant therapy with standard-of-care immunotherapy known as Bacillus Calmette-Guérin, or BCG.

Patients are then monitored with regular cystoscopies and urine cytology every three months to assess for recurrence. Patients with recurrent disease are treated with repeat surgery alternating with intravesical treatments.

NDB-01 is a novel, sustained-release intravesical formulation of two chemotherapy agents, gemcitabine and docetaxel, or Gem/Doce, as we say. It was designed to build on data from numerous studies conducted over the past decade showing that combination use of these two agents achieves response rates and recurrence-free survival that are comparable to or better than historical standard-of-care BCG.

For those who are unresponsive to BCG, it can provide a second-line bladder-sparing option to avoid radical cystectomy. The sustained-release formulation of NDB-01 will be provided to study sites in a ready-to-use format that does not require a specialized pharmacy or biocontainment hood to formulate the Gem/Doce combination.

NDB-01 is intended to be instilled into the bladder through a regular catheter in the office in a less than five-minute intravesical instillation. Upon administration, the formulation creates a soft matrix that is intended to enhance local exposure and minimize systemic toxicity.

Moving to the nine-month data, we're pleased to report that NDB-01's continued positive Phase 2 performance, strongly supporting its potential to transform the treatment of NMIBC. The study is a single-arm, single-center, ex-US trial in patients with high-risk NMIBC.

Patients are treated with NDB-01 in a six bi-weekly induction phase followed by monthly maintenance for up to one year. Patients received regular assessments with cystoscopy, cytology, and if needed, biopsy.

The study is designed to enroll up to 70 patients with localized high-risk NMIBC. The primary endpoints are safety and complete response at 12 months.

Secondary efficacy endpoints are duration of response and event-free survival. Efficacy assessments for the nine-month follow-up included analysis of data at nine months and at any time point.

These are the same safety and efficacy parameters that were applied to the six-month data reviewed during our Q2 call in August and the three-month data presented at the American Urological Association meeting in April. Looking at the data, we observed a complete response rate of 92% at any time based on 25 patients.

Amongst patients with BCG-unresponsive disease, we see a 91% CR anytime. At the nine-month assessment, we observed a complete response rate of 85%.

No patients had progression to muscle-invasive disease, and no patients underwent a radical cystectomy. Patients who have been re-induced had a 60% complete response rate.

The study also includes certain defined subpopulations. For example, patients with BCG-unresponsive disease, we saw 91% CR anytime and a nine-month CR rate of 88%.

NDB-01 continues to demonstrate favorable safety, consistent with our expectations and known efficacy and safety of Gem/Doce. There were no reported new safety signals, no patients who had treatment-related adverse events that were grade three or higher, and no patients discontinued treatment due to adverse events.

The most common treatment-related adverse events were transient dysuria and hematuria and asymptomatic positive urine cultures, an incidental finding observed in 9% of patients, with hematuria only seen in 7%. All patients with dysuria were grade one and resolved within 24 hours.

Our goal is to bring NDB-01 to patients as soon as possible. We intend to initiate the Phase 3 program for NDB-01 in the first half of 2026.

The recent positive Type B FDA meeting is a key milestone that reinforces our confidence in the path forward for NDB-01. I'd like to summarize the key outcomes from the FDA meeting, a very positive, constructive, and pragmatic discussion with them.

Romada secured FDA alignment on certain key elements of the planned Phase 3 pivotal program for NDB-01, incorporating two separate and distinct registrational paths: number one, high-risk, second-line, BCG-unresponsive NMIBC patients; and number two, intermediate-risk NMIBC in the adjuvant setting. In the setting of high-risk, second-line, BCG-unresponsive disease, the FDA stated that a single-arm trial might be acceptable in a more refractory patient population.

We're excited about this approach because it could offer a rapid route to approval. In the indication of intermediate risk in the adjuvant setting, the FDA agreed that a proposal to randomize patients post-TURBT to adjuvant NDB-01 versus observation evaluating a time-to-event endpoint is generally acceptable.

We feel that the opportunity to incorporate NDB-01 into patient care after TURBT is very attractive. It could pave the way for an additional indication and broader clinical adoption.

Importantly, the FDA indicated that no further non-clinical studies are required to support a 505(b)(2) NDA. This is very good news.

We look forward to working with the FDA to complete the study design and initiate the registrational program in the first half of 2026. Our efforts in the coming months will also focus on transferring production to contract manufacturers to complete scale-up and production of clinical batches.

As I hand the call over to our CFO, Maged Shenouda, I am optimistic about the NDB-01 clinical development program based on the excellent nine-month results, positive outcomes with the FDA meeting, and our ongoing Phase 3 preparations. Maged?

Thanks, Raj, and good afternoon, everyone. Today, I'll spend a few minutes on sepranolone and then provide you with an overview of our third-quarter 2025 financials.

Sepranolone is a member of a new subgroup of neurosteroids called GAMSA's, or GABA-modulating steroid antagonists. We believe sepranolone's novel action on the GABA neurotransmitter pathway gives it unique potential to normalize GABAA receptor activity and alleviate the repetitive symptoms in disorders where compulsive behaviors are a common feature.

These disorders affect millions of people in the US 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 for sepranolone.

It affects approximately 350,000 people worldwide, including approximately 20,000 people in the US. 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 the disorder. Phase 2 data from a study in patients with Tourette syndrome established sepranolone's initial efficacy in a compulsivity disorder with good overall tolerability.

We intend to initiate a proof-of-concept study in PWS in the first half of 2026. Our immediate efforts are dedicated to completing study preparations, including engaging with the FDA on our proposed trial design and establishing a robust supply chain.

Moving now to our financial results. As noted earlier by Brian, this afternoon Romada issued a press release announcing our business and financial results for the third quarter and nine months ended September 30th, 2025.

As of September 30th, 2025, Romada had cash, cash equivalents, and short-term investments of approximately $13.9 million, compared to $44.9 million as of December 31st, 2024. Notably, this excludes net proceeds of approximately $94 million from our $100 million underwritten offering of common stock and pre-funded warrants, which the company closed on November 5th, 2025.

Based on current plans, the company believes that its current cash balance, including net proceeds from the offering, is sufficient to support planned expenses into 2028. Cash used in operations in the third quarter ended September 30th, 2025, was $6.7 million, compared to $16.7 million for the same period in 2024.

During today's call, I'll review our third-quarter 2025 financial results. Information regarding the nine-month results are included in our press release and 10-Q filing issued this afternoon.

Research and development expense for the third quarter 2025 totaled $4 million, compared to $11.1 million for the third quarter of 2024, a decrease of $7.1 million. The lower spend was primarily driven by lower study costs with the wind-down of clinical trials for REL-1017, partially offset by an increase in manufacturing and drug storage costs associated with the ramp-up of NDB-01 and sepranolone studies and an increase in R&D employees.

General and administrative expense for the third quarter 2025 totaled $6.3 million, compared to $11.9 million for the third quarter of 2024, a decrease of approximately $5.6 million. The decrease was primarily driven by a decrease in stock-based compensation expense, as well as direct employee and administrative expense.

The net loss for the third quarter of 2025 was $10.1 million, or 30 cents per basic and diluted share, compared with a net loss of $21.7 million, or 72 cents per basic and diluted share, for the third quarter of 2024. Before we open the call for questions, I'll turn back to Sergio for some closing comments.

Sergio?

Thank you, Maged. Before we go to the Q&A session, I would like to share that I'm very pleased with Romada work this year to advance and derisk our portfolio of potentially life-changing therapy for patients.

With our progress comes our gratitude for your support and for taking time to join today's call. 2026 is shaping up to be another very important year for the company, and we look forward to updating you on our continued progress.

Operator, I would like now to open the call for questions.

Hey, guys. Congrats on all the progress that you've made over the last nine months.

Yeah. Takes a lot of doing.

Maybe the first question we have is maybe just help us understand a little bit about the different potential market opportunity for the two, I guess, indications that you are kind of going after. Maybe also, help us understand the sequence of it.

Will you start the study at the same time? When you think that one study will finish before the other and if you can maybe provide some guidance on when each of the study could complete.

Maybe talk about the potential number of patients in the refractory, second-line setting versus the potential number of patients in low-grade, intermediate risk who could benefit from the adjuvant combination of NDB-01 first question. Thanks.

Thank you, Yuye, for the question. I believe Raj, that runs the clinical program, can answer your question appropriately.

Raj, you want to try?

Of course. As I mentioned, there's two proposed indications.

One is in BCG-unresponsive, refractory to first-line therapy. Let me talk a little bit about this population, then the intermediate risk, and then we'll talk about timelines.

This is a relatively smaller population. They're about 8,000 patients per year.

Now with current therapies, 55% to 80% of those patients will recur after first-line therapy. There's a growing number of patients that are needed in this second-line indication.

From 8,000, you can take that down to 55% to 80% that'll each year, that'll be BCG-unresponsive that fail primary therapy. Now, the intermediate-risk population, and this is high-grade and low-grade intermediate risk, is a much larger patient population estimated about 80,000 incident and prevalent patients each year in the United States with intermediate-risk NMIBC.

Significant number of them, probably over half, will receive an adjuvant therapy. That's about 40,000, so that represents a significant market for us to address.

I think if you look at surveys of urologists, chemotherapy and Gem/Doce chemotherapy is the preferred choice. Now regarding your question on timings, our plan is to initiate both of these trials, although they're separate indications, both trials at about the same time in the second quarter of 2026.

I think this'll provide for operational efficiencies in contracting and addressing sites. I think for the sites will be easier as they kind of know how to do a clinical trial one set or the other.

In the unresponsive patient population, well, the first patient in being Q2 '26, we likely have clinical data, three-month data, by Q4 '26 to provide internally and externally, and then the endpoint is going to be a 12-month CR, so that'll be Q2 '27 with top-line data in Q2 '28. In the intermediate-risk study also initiating in Q2 '26, that's an open-label, but randomized study, that'll take probably about 15 months to complete enrollment.

With that completed enrollment, we'll need probably about 18 to 24 months of follow-up. I think it's a little bit tricky.

We plan to do a interim analysis at 70% events. Regarding the ability to provide data before then, I think that's a conversation we'll have to have with the FDA.

Although it's an open-label study, we certainly wouldn't want to expend alpha along the way. I hope that gives you an idea of the sizes of populations and the timelines.

That was super helpful. Maybe just help us with the other element.

With J&J and inlexo, I think the price is $69,000 per dose or per one of those pretzel tubes. If the induction phase is, I think it's what you need eight of those.

That sort of rounds up to about $550,000 a year. Does that sort of make sense?

I know it's probably too early to sort of speak about pricing, just wanted to maybe get your view on what potential pricing could look like.

Let me actually take a quick answer to that, and then I'd like to ask our CEO Sergio to comment. I think you're right.

If you actually add up the induction phase and maintenance phase in the first year for inlexo, it approaches $700,000. That certainly is now set the new benchmark above InTiva if you look at one year of therapy.

The other end of the spectrum to me is Zusduro, which is in low-grade intermediate chemoablation, which the yearly cost there is about $120,000. I think the numbers will fall somewhere between.

Sergio, do you mind if I ask you to comment on that?

No, sure. Thanks, Raj.

Yue, look, it's a bit early to talk about pricing because, right, it will be data driven, depending of the data will look like. We will price accordingly to the value added for patients.

We do have a luxury to watch what the uptake and the penetration of J&J and the other chemotherapy, UroGen, with their pricing, and we'll base our decision based on also how their pricing will be received by the urology community. I hope I answered your question the best way I can, but we don't really have any a specific pricing orientation for now.

Thanks for that. I know it's probably way too early, and you're right, you need to look at the data, but I guess it's kind of encouraging that the pricing is kind of interesting.

Maybe a last question. Maybe just help us to kind of understand a little better with respect to the differentiation from the conventional Gem/Doce.

I think on the call, you mentioned that you need a special biochemical hood, and you need a specialized pharmacist, I guess someone who maybe even licensed who needs to put the product into syringes to be used. Just help us understand, because of this hurdle, where the product is currently used, is it mostly an academic center?

If all of this goes away, how does it open up the market for you if it does? Thanks.

Raj, you want to give your view? That's a wonderful question.

I think has been the hurdle of Gem/Doce. You're right.

We know it works as urologists. We know it works well, like I mentioned, for a decade.

The obstacles for the community urologist, where 70% to 80% of these patients are taken care of in the community, is you need a specialized pharmacy. If you look at the overall procedural time of sequential gemcitabine followed by docetaxel, it's upwards of four hours.

That's easy to do in an academic center, and I think that's where most of the uptake has been, very difficult in the community. Lack of specialized pharmacy and room or chair time and the staff for that for four hours.

I think by having pre-filled syringes, avoiding the specialized pharmacy, and having a five-minute or so instillation through a catheter, removing the catheter, watching the patient, allowing them to go home, I think this is an opportunity for academic centers as well, but I think also to meet the patients where they're at and to meet the urologist where they're at as well. I think it opens up the market significantly.

Okay. Sorry, maybe just one additional question.

I know you're going after just the two indications, which is actually quite broad, particularly in the intermediate-risk section. There is an ongoing study in BCG-naive patients, called I guess the BRIDGE study.

If this study succeeds, what does that do to the potential opportunity for this product to be used off-label, even though you won't be promoting it? Cuz every doc will probably know about your product.

Raj, you want to give your view?

Yeah. Thank you, Sergio.

That's a very insightful question, Yuye. Actually Max Kates, who we know heads the BRIDGE trial.

The BRIDGE trial is a randomized study of BCG versus Gem/Doce in high-risk disease. It's a 800-patient trial, cooperative group trial that is near end of enrollment and will read out in two years, the timing's nice for us.

It's meant to look if Gem/Doce is non-inferior to BCG. We know that the obstacles with BCG now are supply issues, and that's been ongoing for 15 years in the US, globally.

Also, it does have toxicity to it. It's effective, but it does have toxicity.

If now you introduce the ability of Gem/Doce to substitute in for BCG, Yuye, I think that especially as you said, in an off-label use, an easier way to give it, I think that opens the market significantly. That's a tremendous opportunity for Romada.

Great question. Thank you.

Okay.

Thank you.

Thank you very much, and thank you, everyone. Just an extended thank you to investors, patients, and employees, collaborators, consultants that has helped us to get where we are now, and they will continue to help us to get where we want to be, that is to bring NDB-01 and sepranolone available for doctor and patients.

Thank you very much, and I wish everyone a great evening for the rest of the day. Thank you.