Q2 2026 Relmada Therapeutics Inc Earnings Call

August 6, 2026

Speaker #1: 1, good afternoon, and welcome to RELMADA THERAPEUTICS, second 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.

Operator: Good afternoon, and welcome to Relmada Therapeutics' Q2 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 Joyce Lonergan. Please go ahead.

Speaker #1: 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 RELMADA website.

Speaker #1: I would now like to turn the call over to Joyce Longham. Please go ahead.

Speaker #2: Thank you, operator. 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 six months ended June 30, 2026.

Joyce Lonergan: Thank you, operator. 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 six months ended 30 June 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 Q2 ended 30 June 2026, filed after the close today.

Speaker #2: 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.

Speaker #2: Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and 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.

Speaker #2: 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.

Joyce Lonergan: This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast on 06 August 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.

Speaker #2: 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 is RELMADA's Chief Executive Officer, Sergio Traversa, who will provide a business update.

Speaker #2: Vipin 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.

Joyce Lonergan: 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 Q2 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 Traversa. Sergio?

Speaker #2: After that, we will open the line for a brief Q&A session. Now, I would like to hand the call over to Sergio Traversa. Sergio?

Speaker #3: Thank you, Joyce. Good afternoon, everyone, and 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.

Sergio Traversa: Thank you, Joyce. Good afternoon, everyone, and welcome to the Relmada Q2 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 GemDoce, that builds on the well-established safety and efficacy profile of conventional GemDoce. 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 United States alone. Our clinical and regulatory foundation is strong.

Speaker #3: 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.

Speaker #3: NDV-01 is a novel sustained release intravesical formulation of Gencitabine and Dosetaxel, or Gendosi, that builds on the well-established safety and efficacy profile of conventional Gendosi.

Speaker #3: We believe NDV-01 has the potential to be a best-in-class

Speaker #1: Stared at me . For patients with non-muscle invasive bladder cancer , or nmibc , a disease affecting more than 744,000 people in the United States alone Our clinical and regulatory foundation is strong The 12 month phase two data are compelling .

Sergio Traversa: The 12-month 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 a scalable and registrational standards is demanding work. It requires a specialized capability, coordination across several supply chain partners, and a 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.

Speaker #1: 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 , and we continue to see strong interest from the Uro oncology community .

Speaker #1: Let me go directly to manufacturing because it is our immediate priority , Nbia one is a novel , sustained release therapy that combines two chemotherapies in a single delivery system Manufacturing a product like this to a scalable and registrational standards is demanding work .

Speaker #1: It requires a specialized capability, coordination across several supply chain partners, and scaling up from a laboratory prototype to full Good Manufacturing Practice, or GMP, production.

Speaker #1: We have done the to understand what that requires . We also have planned the remaining activities needed to support the end , and we are executing against a clear plan to complete them work driven to quality and we are dedicated to getting it done right Importantly , all the components around manufacturing are ready .

Sergio Traversa: 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.

Speaker #1: We have hefty 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.

Speaker #1: We plan to file the IND for Nvo-1 by year-end 2026 and to initiate the Phase 3 Rescue Registrational program upon IND clearance. The same discipline applies to Sepranolone.

Speaker #1: Our program in Prader-Willi syndrome or . P.w.s . A rare and underserved condition estimated to affect 350 zero zero 0 to 400 000 people worldwide Here , the formulation development is complete and the one remaining step is finalizing the prefilled syringe delivery system .

Sergio Traversa: Here, the formulation development is complete, the one remaining step is finalizing the prefilled syringe delivery system. We expect to file the sepranolone IND by year-end 2026 as well, 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 US 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.

Speaker #1: We expect to file a soprano IND by year end 2026 , as well , and to initiate phase two proof of concept study upon an IND clearance .

Speaker #1: So 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 Vipin Dalmia , our new Chief Business Officer .

Speaker #1: Bipin joined us this quarter and brings nearly three decades of experience in neuro oncology business development and manufacturing oversight , including leading the US launch of the first FDA approved Intravesical gene therapy for Nmibc .

Speaker #1: BP also brings strong industry relationships and an outstanding track record of value creation BP toll on you

Speaker #2: Thank you Sergio , and good afternoon everyone . As Sergio mentioned , I've spent nearly three decades in biopharmaceuticals , including many years focused on neuro oncology and non-muscle invasive bladder cancer , or nmibc During my first two weeks with the company , I've spent considerable time reviewing and v once clinical , regulatory and manufacturing plans , as well as our patent strategy .

Bipin Dalmia: 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 2 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.

Speaker #2: That work has only strengthened my belief that Nvo one 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 .

Speaker #2: The primary goal of treatment . And 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 .

Speaker #2: Our market research and 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 .

Bipin Dalmia: 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.

Speaker #2: And 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 .

Speaker #2: Naive settings . And that is where we believe Nvo one has the potential to differentiate itself . What I find particularly about Nvo one is that we're building on a strong clinical foundation , rather than starting from scratch .

Speaker #2: 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 .

Bipin Dalmia: 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.

Speaker #2: In summary , the combination of a well-established therapeutic foundation encouraging efficacy and durability results from our phase two study , favorable safety and tolerability , practical ease of use , and applicability across most nabs Nmibc patient populations differentiates MTV oh one from many current and emerging approaches in the field .

Speaker #2: Combined with a clear FDA agreed regulatory path and strong patent protection Taken together , these attributes support our belief that Nvo one . 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 .

Speaker #2: While important work remains ahead The path forward is well defined . We have an experienced team and strong external partners focus on executing against a clear plan and well-defined near-term milestones I'm excited to be part of this important stage and look forward to helping advance Nvo one for patients who need new treatment options .

Bipin Dalmia: 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?

Speaker #2: With that , I'll turn the call over to Majid . Majid

Speaker #3: Thank you Vipin , and good afternoon , everyone . I'll walk you through our second quarter 2020 financial results . Our press release and 10-q filings provide the full details .

Maged Shenouda: Thank you, Bipin, and good afternoon, everyone. I'll walk you through our Q2 2026 financial results. Our press release and 10-Q filings provide the full details. Relmada closed the Q2 2026 with cash equivalents, and short-term investments of $217.7 million, compared to $93 million on 31 December 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 Q2 financial results. Research and development expense for the three months ended 30 June 2026 totaled $8.4 million, compared to $2.8 million for the three months ended 30 June 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.

Speaker #3: Relative . Close . The second quarter of 2026 with cash , cash equivalents and short term investments of $217.7 million , compared to $93 million on December 31st , 2025 .

Speaker #3: Our current cash resources are expected to fund company operations through 2029 , including completion of the phase three rescue program for Nvo one .

Speaker #3: Moving briefly through our second quarter financial results Research and development expense for the three months ended June 30th , 2026 totaled $8.4 million , compared to $2.8 million for the three months ended June 30th , 2025 .

Speaker #3: The increase was primarily attributable to higher novel and sepranolone study costs and increased manufacturing and drug storage costs , partially offset by lower employee compensation General and administrative expense for the same period totaled $6.6 million , compared to $7.4 million for the same period last year .

Maged Shenouda: General and administrative expense for the same period totaled $6.6 million, compared to $7.4 million for the same period last year. The decrease was primarily driven by lower stock-based compensation and lower employee compensation, partially offset by higher stock appreciation rights expense and consulting services. Net cash used in operating activities for the three months ended June 30, 2026 totaled $9.6 million, compared to $6.4 million for the same period in 2025. The net loss for the quarter was $12.9 million or $0.11 per basic and diluted share, compared with a net loss of $9.9 million or $0.30 per basic and diluted share for Q2 2025. Before we open the call for questions, I'll turn back to Sergio for some closing comments. Sergio?

Maged Shenouda: General and administrative expense for the same period totaled $6.6 million, compared to $7.4 million for the same period last year. The decrease was primarily driven by lower stock-based compensation and lower employee compensation, partially offset by higher stock appreciation rights expense and consulting services. Net cash used in operating activities for the three months ended June 30th, 2026 totaled $9.6 million, compared to $6.4 million for the same period in 2025. The net loss for the quarter was $12.9 million or $0.11 per basic and diluted share, compared with a net loss of $9.9 million or $0.30 per basic and diluted share for Q2 2025. Before we open the call for questions, I'll turn back to Sergio for some closing comments. Sergio?

Speaker #3: The decrease was primarily driven by lower stock based compensation and lower employee compensation , partially offset by higher stock appreciation rates , expense and consulting services .

Speaker #3: Net cash used in operating activities for the three months ended June 30th , 2026 totaled $9.6 million , compared to $6.4 million for the same period in 2025 .

Speaker #3: The net loss for the quarter was $12.9 million , or $0.11 per basic and diluted share , compared with a net loss of $9.9 million , or $0.30 per basic and diluted share .

Speaker #3: For the second quarter of 2025. Before we open the call for questions, I'll turn back to Sergio for some closing comments.

Speaker #3: Sergio

Speaker #1: Thank you maggot I believe we can open the call for questions , but before we do that , let me close on this .

Sergio Traversa: Thank you, Maged. I believe we can open the call for questions, before we do that, let me close on this. Relmada is in a position of strength

Speaker #1: Ramada is in a position of strength We have a differentiated , clinically validated acid in N d v of one with FDA alignment on our path to registration .

Sergio Traversa: We have a differentiated, clinically validated asset in NDV01 with FDA alignment on our path to registration, a phase III program that is ready to enroll, and the capital to see this work through. Our focus now is execution, completing the manufacturing work to the highest standard and filing both the NDV01 and sepranolone INDs by year-end. We know what is front of us, we have a clear plan, and we have the team and the resources to deliver. I'm very confident in this program and optimistic about Relmada's future. I look forward to keeping you close to our progress along the way. Operator, I would like now to open the call for questions. Thank you.

Speaker #1: A phase three program that is ready to enroll and the capital to see this work through . Our focus now is execution Completing the manufacturing work to the highest standard and filing both the N , D , V oh one and INDs by year end .

Speaker #1: We know what is front of us . We have a clear plan and we have the team and the resources to deliver I'm very confident in this program and optimistic about the future .

Speaker #1: I look forward to keeping you close to our progress along the way Operator . I would like now to open the call for questions .

Speaker #1: Thank you

Operator: 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 the line of Uy Ear of Mizuho. Please go ahead.

Speaker #4: As a reminder , if you would like to ask a question , please press star one on your telephone keypad Our first question comes from the line of we year of Mizuho Please go ahead .

Speaker #5: Hi guys . I'm Yeah . Thanks for holding this call . And I guess we just have a couple of questions from reading your press release Before I ask the questions .

Uy Ear: Hi, guys. Thanks for holding this call. I guess, we just have a couple of questions from reading your press release. Before I ask the questions, I also want to welcome Bipin to Relmada and hope to work with you in the future. Maybe, a general question for Bipin first. Maybe just help us understand what your role at Relmada and how do you envision bringing NDV-01, essentially from this stage up to commercialization. The second question is, based on your press release, it seems that you indicated manufacturing as well as CMC activities. Maybe just help us get some more color on the gating factors for both of these items. Is there issues with the release of the chemo from the gel? Is it scaling? Is it just consistency, stability? Maybe just help us get a flavor. Thank you.

Speaker #5: I also want to welcome Vivien to Ramada . Hope to work with you in the future . So maybe a general question for Vivian first , maybe just help us understand what your role at role Malta and what your .

Speaker #5: How do you envision bringing . NDV01A essentially from this stage up to commercialization ? And the second question is based on your press release , it seems that , you know , you indicated manufacturing as well as CMC activities , maybe just help us get some more color on the gating factors for both of these items .

Speaker #5: Is it , you know , is , is , is there issues with the release of the , the , the chemo from the gel ?

Speaker #5: Is it scaling up ? Is it just consistency , stability , just maybe just help us get a flavor . Thank you

Speaker #1: Sure . Thank you . Maybe maybe you want to take the first one . Then we can . All of us can take the second one .

Sergio Traversa: Sure. Thank you, Oi. Maybe, Bipin, you want to take the first one. All of us can take the second one.

Speaker #2: Yeah . Sergio . So thank you . I also look forward to working with you So my role as Chief Business Officer and primarily responsible for the NDVO1 program will be corporate strategy , commercial planning , which includes new product planning , making sure our program maximizes the potential of NDVO1 business development .

Bipin Dalmia: Sergio. Thank you, Oi. I also look forward to working with you. My role, as Chief Business Officer, and primarily responsible for the NDV-01 program, will be corporate strategy, commercial planning, which includes new product planning, making sure our program maximize the potential of NDV-01, and business development, if and when that becomes relevant. I also bring a lot of development in manufacturing experience, in addition to commercial. I will be very closely involved in all aspects of NDV-01.

Speaker #2: If and when that becomes relevant . But I also bring a lot of development in manufacturing experience in addition commercial . So I will be very closely involved in all aspects of NDVO1 .

Speaker #1: Thanks . Weeping . I hope . Yeah , I hope I this answer your first question . The second we can take , I mean , I can , I can start right .

Sergio Traversa: Thanks, Bipin.

Bipin Dalmia: Thank you.

Sergio Traversa: Yeah. I hope, Oi, this answers your first question. The second one we can take. I can start, right? Look, manufacturing is always like, you can go as much as in detail as we want to. The top-down is that the formulation has been locked, the process has been locked. Now is the question of getting into the, would I say, the schedule of the manufacturer. Our manufacturer is Piramal. It is pretty large company. To get on their schedule and make the product and then that would be made at the scalable quantity. That's where we are with manufacturing. That's where we are. Maybe, Bipin, you want to add something to the topic, the subject?

Speaker #1: Look , manufacturing is always like you can go as much as in , in detail as , as we want to , but the , the top down is that the formulation has been locked .

Speaker #1: The process has been locked . So now it's a question of getting into the . I would would I say the the schedule of the manufacturing , you know , you know , how manufacturers paramount .

Speaker #1: It is a pretty large company. And so the idea is to get on their schedule, schedule, and make the product. And then that would be made at the scalable quantity.

Speaker #1: So that's , that's where we are with manufacturing . So it's , that's where we are . You want to add something to the topic , the .

Speaker #2: Subject . No , absolutely . I think Sergio , we have the formulation , which is the same as the formulation we used in phase two .

Bipin Dalmia: Yeah, no. Absolutely, I think, Sergio. We have the formulation, which is the same as the formulation we used in phase II. We of course have a new scalable process, and that is locked now. We have analytics in place, so the analytical program is complete. Now it's just a matter of blocking and tackling, and producing the GMP batches and putting them on stability, needed for R&D filing. That's where we are. It's just a matter of execution now.

Speaker #2: We of course have a new scalable process . And that is locked now . So the remaining active we have analytics in place .

Speaker #2: So the program is complete . So now it's just a matter of blocking and tackling and producing the GMP batches and putting them on stability needed for R&D filing .

Speaker #2: And that's where we are . We it's just a matter of execution . Now .

Speaker #5: So you're kind of saying that it's primarily an engineering issue that you can resolve relatively quickly . Is that a way of summarizing it Yeah .

Uy Ear: You're kind of saying that it's primarily an engineering issue that you can resolve relatively quickly. Is that a way of summarizing it?

Sergio Traversa: Yeah.

Bipin Dalmia: Yeah. Sergio, I can say it.

Speaker #2: I can yeah , yeah .

Sergio Traversa: Yeah, take it. Go ahead, Bipin.

Speaker #1: Take it . Go ahead . Meetings .

Speaker #2: Yeah . So in manufacturing , you have to develop a formulation . You have to develop a process . That's the development activities .

Speaker #2: And then you have the mini facturing activities . So there is the development activities are complete . The manufacturing activities are our next focus .

Bipin Dalmia: The manufacturing activities are our next focus, and that takes some time because you have to get on the schedule of the GMP clean room, and we're working with an external partner for that. Once we've manufactured the GMP batch, we need some degree of stability data needed to file in the IND. I wouldn't call it an engineering or a non-engineering platform. The way to think about it is development is complete, and now manufacturing is what we will do in the coming months.

Speaker #2: And that takes it some time because you have to get on the schedule of the GMP kind of clean room and we're working with an external partner for that .

Speaker #2: And then once we manufactured the GMP batch , you need some degree of stability data needed to file in the IND . So I wouldn't call it an engineering or a non engineering problem .

Speaker #2: The way to think about it is development is complete . And now manufacturing is what we will do in the next in the coming months

Speaker #1: Thank you .

Sergio Traversa: Thank you, Bipin.

Speaker #5: Super helpful . Thanks

Uy Ear: Super helpful. Thanks.

Speaker #4: Okay . Our next question comes from Farhan Haq of Jefferies . Please go ahead .

Operator: Okay. Our next question comes from Farhan Khan of Jefferies. Please go ahead.

Speaker #6: Hi . Thank you for taking my question . Just to follow up on the last one , do you need FDA input on the GMT ?

Farhan Khan: Hi. Thank you for taking my question. Just to follow up on the last one, do you need FDA input on the CMC once you have the manufacturing batch GMP ready prior to filing?

Speaker #6: Once you have the manufacturing batch GMP ready prior to filing

Sergio Traversa: Yeah. Thank you, Farhan. Bipin, do you want to take this? I don't believe so. I mean, we already had the minutes from the meetings we had with the FDA on the development. We'll just file the IND, but Bipin, you are more expert, so you can.

Speaker #1: Yeah , thank you for do you want to take this ? I don't believe so . I mean , the we already had the minutes from the meetings we had with the FDA on the development .

Speaker #1: So we'll just file the IND . But you are more expert . So you can

Bipin Dalmia: No, I don't believe we need any FDA input before filing the IND.

Speaker #2: Know I don't believe we need any FDA input before filing the IND .

Farhan Khan: Got it. Then how many sites are being planned, and basically, how quickly can you go from the IND clearance to the first patient dosed?

Speaker #6: Got it . And then how many sites are being planned and how much . Basically , how quickly can you go from the IND clearance to the first patient dosed ?

Sergio Traversa: Oh, thank you for that. That's a great question. It's also easy to answer. We have around, I believe, 80 sites enrolled, of which 60 are primary and 20 are more backup, and to speed up the enrollment. I believe as soon as the IND is clear, that would be 30 days after we file it. Technically, we can start to enroll patients at any time. Everything else is pretty much good to go. We are waiting for the product to be delivered and the data on the product to be delivered, to file the IND. 30 days later, hopefully, we'll be okay for clearing, and then we can start to enroll pretty much right after the IND is cleared.

Speaker #1: Oh , thank you for that . That's a great question . It's also easy to To to answer . We have around , I believe , 80 sites enrolled , of which 60 are primary and 20 are more backup .

Speaker #1: And to speed up the the enrollment . And I believe as soon as the IND is clear , there will be 30 days after we filed .

Speaker #1: Technically , we can start to enroll patients at any time . So everything else much good to go . We , you know , we are waiting for the product to be delivered and the data on the product to be delivered to file the I , N , D and 30 days later , hopefully will be okay for clearing .

Speaker #1: And then we can start to enroll pretty much right , right after we IND is clear .

Farhan Khan: Got it. A quick follow-up. Do you have any plans to disclose the 18 months cut from the phase II data later this year?

Speaker #6: Got it . And then a quick follow up . Do you need do you have any plans to disclose the 18 months cut from the phase two data later this year

Sergio Traversa: It's a great question. Well, yes. To be honest, we haven't focused on the phase II. The site in Israel has continued to enroll patients, but we have been totally focused on the phase III preparation. We'll probably, yes, we'll publish the 18 data at some point, but we don't have specific plan to do it. We have not seen the data after the 12 months, so at some point we'll probably publish that. The focus has been the registration more than anything else.

Speaker #1: It's a great question . Well , yes . We haven't looked to be honest . We haven't focused on the phase two . I the the the the site in Israel is continue to enroll patients .

Speaker #1: And but we have been totally focused on the on the phase three preparation , we'll probably yes , we'll publish the . 18 data at some point , but we don't have specific plan to do it .

Speaker #1: We have not seen the data after the 12 months. So at some point, they will probably publish that. But the focus has been the registration more than anything else.

Farhan Khan: Thank you so much.

Speaker #6: Thank you so much .

Sergio Traversa: Thank you, Farhan.

Speaker #1: Thank you for the

Operator: Your next question comes from Kelsey Goodwin of Piper Sandler. Please go ahead.

Speaker #4: Your next question comes from Kelcie Goodwin of Piper Sandler . Please go ahead

Kelsey Goodwin: Oh, great. Hey, thanks for taking our questions. First, just to circle back, on the NDV-01 IND, I guess, what steps or tasks required took longer than you were expecting when you had initially guided to mid 2026? Secondly, I know you had initially guided to some clinical data later this year, that three-month CR look. Should we expect that in H1 now, or are you maybe reevaluating what the initial disclosure is going to look like? That's it for me. Thank you.

Speaker #7: Oh , great . Hey , thanks for taking our questions . First , just to circle back on the Nvo one ind , I guess what steps or tasks required took longer than you were expecting when you had initially guided to mid 26 .

Speaker #7: And then secondly , I know you had initially guided to some clinical data later this year that three months CR look , should we expect that in the first half now , or are you maybe reevaluating what the initial disclosure is going to look like ?

Speaker #7: That's it for me . Thank you .

Sergio Traversa: Hey, Kelsey. Good afternoon. Great to hear from you. These are actually two different questions, right? Require two different answers. One, what was unexpected? Well, when we made the initial projection, it's like we kind of listened to the manufacturer and was the best educated guess, to give a timeline. I don't think, and Bipin and Maged, you have been involved too in the manufacture. There was really nothing unexpected. It's just everything in manufacturing until you're done and you are to the final, you never know. It's trial and error. There was just a question. I would say probably the biggest hurdle is always to get into the manufacturing schedule, because it's not that you call and they put the product in manufacturing right away. Usually there is at least one or two or three months where they give you a slot.

Speaker #1: Hey , Cassie . Good afternoon . Great to hear from you . The there's actually two different questions , right ? The and require two different answers .

Speaker #1: One , what was unexpected ? Well , you know , when we made the initial projection , it's like we kind of listen to the manufacturer and , you know , what's the best educated guess to give a timeline , but like , if I don't think and BP and Magadi , you have been involved to in the manufacturer , there was really nothing unexpected .

Speaker #1: It's just , you know , everything in manufacturing until you have done and you have to the final , you never know . So it's a , it's a trial and error .

Speaker #1: And there was just a question , I would say probably the most the biggest hurdle is always to get into the manufacturing schedule because not that you call .

Speaker #1: And they put the product in , in manufacturing right away . Usually there is at least one or 2 or 3 months where they give you a slot to make the product .

Sergio Traversa: To make the product, it takes technically two days. It's not a lot of time, but you have to get in their schedule and they have other clients. That was not unexpected, but it's still something that we have to get done. That's where we are. The second question was, remind me.

Speaker #1: It takes technically two days . It's not very it's not a lot of a lot of time , but you have to get in their schedule and they have other clients and , and so that was not unexpected , but it's still something that we have to get done .

Speaker #1: And so that's , that's , that's where we are . So , and the second question was , remind me was the .

Kelsey Goodwin: Yeah, the initial clinical data that was guided for the end of the year, the three-month CR data. Will that be pushed into H1 2027, or are you thinking about maybe just doing a different disclosure altogether?

Speaker #7: The yeah , the initial clinical data that was guided for the end of the year , the three month CR data just , you know , will that be pushed into the first half of 27 or are you thinking about maybe just doing a different disclosure altogether ?

Sergio Traversa: Yeah, look, we haven't decided yet. We've been hearing a different opinion from all the people that are helping us on doing this. The current tendency, yes, it would be, I would say, H1, but the current trend or what we think is that We would like to have a certain number of patients, not to publish data on five patients, right? To have a certain number of patients and make it relevant. I don't know what the number is, but it's probably 15, 20 patients so that it's significant. Four or five patients don't really mean anything, or not much. The second one, the three months, they may not be that representative, for the retreatment is allowed after three months. If the patient doesn't respond after three months can be retreated.

Speaker #1: Yeah . Look , we haven't decided yet . We've been hearing different opinion from all the people that are helping us on doing this .

Speaker #1: The current tendency , yes , it would be , I would say first half , but the current trend or what we think is that we would like to have a certain number of patients not to publish data on five patients , right .

Speaker #1: To have a certain number of patients and make it relevant . I don't know what the number is , but it's probably 15 , 20 patients .

Speaker #1: So it's significant , you know , 4 or 5 patients don't really mean anything or not much . And the second one , you know , the the three months , they may not be that representative for like the retreatment is allowed after three months .

Speaker #1: So the patient doesn't respond after three months can be retreated . So probably the six months is a lot more meaningful in terms of showing what the real results are .

Sergio Traversa: Probably the six months is a lot more meaningful in terms of showing what the real results are. We haven't decided yet. The focus is really to file the IND to get the trial started, then we can think about the data. It's an open label, one arm, so we can see the data. Hope I answered your question.

Speaker #1: But we haven't decided yet. So the focus is really to find the A and D to get the trial started. Then we can think about the data.

Speaker #1: It's an open label , one arm . So we can see the data right . Hope I answer your question .

Kelsey Goodwin: Yeah, that's perfect. Thank you so much.

Speaker #7: Yeah that's perfect . Thank you so much .

Sergio Traversa: Thank you, Kelsey.

Speaker #1: Thank you . Kelsey

Operator: As a reminder, if you would like to ask a question, please press star one. All right, we have another question from Farhan Khan of Jefferies. Please go ahead.

Speaker #4: As a reminder , if you would like to ask a question , please press star one . All right . We have another question from Farhan Haq of Jefferies .

Speaker #4: Please go ahead .

Farhan Khan: Thank you for taking the follow-up. Just to clarify in your last comment, ClinicalTrials.gov allows one reinduction after disease recurrence.

Speaker #6: Thank you for taking the follow up . Just to clarify , in your last comment , the clinical trials.gov allows one re-induction after disease recurrence .

Sergio Traversa: Correct.

Farhan Khan: Does the reinduction count towards the primary CR endpoint, or is it captured as a secondary?

Speaker #6: So, does that re-induction count towards the primary CR endpoint, or is it captured as a secondary?

Sergio Traversa: Thanks for the question. Give me a chance to clarify. The primary endpoint is a response at any time. The 6 months is any time there's a high response during the trial.

Speaker #1: Well , the thanks for the question . Sorry . Give me a chance to clarify the primary endpoint is response . At any time So that's the six months is any there's a high response during the trial .

Farhan Khan: The patients can have one reinduction if needed?

Speaker #6: So the patients can have one re-induction if needed.

Sergio Traversa: Correct.

Farhan Khan: Okay. Got it. Thank you.

Speaker #1: Correct .

Speaker #6: Okay . Got it . Thank you .

Sergio Traversa: If they don't respond at 3 months, they can be renewed, and they may respond at 6 months. For the primary endpoints, the highest response rate is the one that matters. Thanks for the question. It was important.

Speaker #1: So, if they don't respond, they can be renewed, and they may respond to six months. So, for the primary endpoints, the highest response rate is the one that matters. Thanks for the question; it was important.

Operator: All right, looks like we have another question from Wei Ear of Mizuho. Please go ahead.

Speaker #4: All right. Looks like we have another question from We Ear of Mizuho. Please go ahead.

Uy Ear: Hey, guys. Yeah, thanks for taking the follow-up. I just wanted to ask, I don't know if you guys or Raj has watched the FDA AdCom on the Replimune product. I just wanted to see if you think that there's any read-through to your second line development for NDV-01 plus. Yeah, just wanted to see if you think there's any read-through considering that I guess the FDA was looking for a large response rate and, in their opinion, it wasn't really the case. The AdCom looked at it sort of differently and saw a signal and I think took into consideration.

Uy Ear: Hey, guys. Yeah, thanks for taking the follow-up. I just wanted to ask, I don't know if you guys or Raj has watched the FDA AdCom on the Replimune product. I just wanted to see if you think that there's any read-through to your second line development for NDV-01+. Yeah, just wanted to see if you think there's any read-through considering that I guess the FDA was looking for a large response rate and, in their opinion, it wasn't really the case. The AdCom looked at it sort of differently and saw a signal and I think took into consideration.

Speaker #5: Hey guys . Yeah . Thanks for taking the follow up . I just wanted to ask , I don't know if you if if you guys are Raj has watched the FDA adcom on the Replimune product and I just wanted to see if you think that there's any read through to your second line , your second line development , you know , for in oh one as and yeah , just wanted to see if you think there's any read through , considering that , you know , the , I guess the FDA was looking for a large response rate and , and in their opinion , it wasn't really the case , but the Adcom looked at the sort of differently and saw a signal .

Speaker #5: And I think took into significant into consideration .

Maged Shenouda: Maybe I can step in here. I think it's imprudent for us to comment on other companies' AdComs and different disease areas as well. I don't know that it would be, again, prudent for us to comment here. Thank you for the question, Wei.

Speaker #3: Maybe I can . Maybe I can step in here . You know , it's I think it's important for us to comment on , you know , other companies Adcoms and different disease areas as well .

Speaker #3: So I don't , you know , I don't know that it would be , again , prudent for us to comment here . But thank you for the question .

Sergio Traversa: Yeah, there are different indications and what we can share is that with the meeting with the FDA, there is no fixed number about what kind of response rate the FDA expects to approve NDV-01, and I believe they stated that they want to see the overall data in terms of response rate and durability. It's really different from any other comparison.

Speaker #1: Yeah , there are different indications and what what we can share is that with a meeting with the FDA , there is no fixed number about what kind of response rate the FDA expects to approve Nvo one , and I believe they stated that they want to see the overall data in terms of response rate and durability .

Speaker #1: So it's really different from like any other comparison

Uy Ear: Okay. Thanks.

Speaker #5: Okay . Thanks .

Sergio Traversa: Thank you.

Speaker #1: Thank you

Operator: This concludes our question and answer session and call for today. Thank you, everyone. You may now disconnect.

Speaker #4: This question and answer session and call for today . Thank you everyone . You may now disconnect .

Sergio Traversa: Thank you. Thank you all.

Speaker #1: Thank you . Thank you all

Maged Shenouda: Thanks.

Q2 2026 Relmada Therapeutics Inc Earnings Call

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