Q2 2025 Relmada Therapeutics Inc Earnings Call
After the prepared remarks, we will conduct a question and answer session to ask a question. Please press star one as.
As a reminder, this conference call is being recorded and will be available for replay on the Romano website.
I would now like to turn the call over to Brian Ritchie from buy side Advisors. Please go ahead Mr. Ritchie.
Thank you.
Good day, everyone and thank you for joining us today.
Afternoon Romano issued a press release, providing a business update and outlining its financial results for the three months ended June 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 for a modest management team will be making forward looking statements actual results could differ materially from those stated or implied by these forward looking statements.
Speaker #5: Good afternoon, and welcome to the Relmada Therapeutics second quarter 2025 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.
Risks and uncertainties associated with the company's business.
These forward looking statements are qualified by the cautionary statements contained in real modest press release issued today and the company's SEC filings, including in the annual report on Form 10-K, excuse me in the quarterly report on Form 10-Q for the quarter ended June 30th 2025 filed after the close.
Speaker #5: 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.
Speaker #5: I would now like to turn the call over to Brian Ritchie from Lifeside Advisors. Please go ahead, Mr. Ritchie.
Today.
This conference call also contains time sensitive information that is accurate only as of the date of this live broadcast on August seven 2025.
Speaker #6: Thank you. Good day, everyone, and thank you joining us today. This afternoon, Relmada issued a press release providing a business update and outlining its financial results with a three-month ended June 30th, 2025.
Romano 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 I'll read them out at Romano's CEO, Dr. Sergio traversing who will briefly provide a summary of recent business highlights Dr.
Speaker #6: Please note that certain information discussed on the call today is covered under the Safe bor provision of the Private Securities Litigation Reform Act. We caution listeners that during this call, Relmada's management team will be making forward-looking statements.
<unk>.
Romano CMO, who will provide an overview of M. D. B O. One enroll modest CFO magazine out of who will provide an update on the separate alone and a review of the company's Q2 financial results. After that we will open the call.
Speaker #6: 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 in the annual report on Form 10-K, and in the quarterly report on Form 10-Q for the quarter ended June 30, 2025, filed after the close today.
For a brief Q&A session now I would like to turn the call over to Sergio Traverse Sergio.
Thank you Brian Good afternoon, and welcome everyone to their real mother second quarter 'twenty to 'twenty five conference call.
Speaker #6: This conference call also contains timed sensitive information that is accurate only as of the date of this live broadcast on August 7th, 2025. Relmada undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call.
During today's call I will provide an overview of our recent progress and upcoming milestones.
After that <unk> will review the updated six month phase II data for <unk>, one that we announced today.
Maggie will prevent provide an update on say a prominent and review our financial results that will then make a few closing remarks, we will take your questions.
Speaker #6: With me on today's call, are Relmada's CEO, Dr. Sergio Traversa, who will briefly provide a summary of recent business highlights. Dr. Raj Puthi, Relmada's CMO, who will provide an overview of NDV01 and Relmada's CFO, Maged Shenouda, who will provide an update on separalonin.
<unk> is making good progress this year to get started I would like to highlight four points.
First.
We are excited about the two product candidates that we added to the company and give you one for non muscle invasive bladder cancer or N M. I V.
Speaker #6: And a review of the company's Q2 financial results. After that, we will open the call for a brief Q&A session. Now, I would like to turn the call over to Sergio Traversa.
C and sit Brian alone for compulsive disorders, starting with prouder Willi syndrome or <unk> W. S.
And have you won and to Brian around are well aligned with our product acquisition criteria.
Speaker #6: Sergio?
Speaker #7: Thank you, Brian. Good afternoon and welcome everyone to the Relmada second quarter 2025 conference call. During today's call, I will provide an overview of our recent progress and upcoming milestones.
They have demonstrated proof of concept data and good overall safety in their initial studies and they have the potential to be first in class programs.
In addition, they each address significant and underserved markets with potential to expand beyond the first indication.
Speaker #7: After that, Raj Puthi will review the updated six-month phase two data for NDV01 that we announced today. Maged will provide an update on separalonin and review our financial results.
Second.
We are pleased to report that the six months follow up from the Phase II study or <unk> are used impressive response rates with 91% of patients achieving high grade disease status Danny.
Speaker #7: And I will then make a few closing remarks, and we'll take our questions. Relmada is making good progress this year. To get started, I would like to highlight four points.
Any time points following <unk> treatment.
Speaker #7: First, we are excited about the two product candidates that we added to the company. NDV01 for non-muscle invasive bladder cancer, or NMIBC, and separalonin for compulsivity disorder, starting with Prader-Willi syndrome, or PWS.
As a reminder.
And Dave you want is a sustained release formulation of gen side, they've been inbox attacks or Jim dosing.
Third.
We have expanded our team with the addition of two highly respected expert in bladder cancer and urology Urologic oncology.
Speaker #7: NDV01 and separalonin are well aligned with our product acquisition criteria. They have demonstrated proof of concept data and good overall safety in their initial studies.
Dr Raj prudent as Chief Medical Officer oncology and Dr. Jay Luton is chair of our clinical Advisory Board.
We believe the contribution will be instrumental to our success.
Speaker #7: And they have the potential to be first-in-class programs. In addition, they each address significant and underserved markets with potential to expand beyond the first indication.
And fourth.
We have made significant progress toward our objective of bringing each program to patients as soon as possible with preparation underway to begin the next set of studies for <unk> and <unk> alone in 2026.
Speaker #7: Second, we are pleased to report that the six-month follow-up from the phase two study, or NDV01, produced impressive response rates. With 91% of patients achieving high-grade disease-free status at any time point, following NDV01 treatment.
We have two promising product candidates and expanded men's and team and clinical advisory board, a $26 million cash balance and a clean balance sheet.
I believe <unk> is well positioned to take the next value creating steps for each program.
Speaker #7: As a reminder, NDV01 is a sustained-release formulation of Gencitabine and Doxytaxel, or Gemdosi. Third, we have expanded our team with the addition of two highly respected expert in bladder cancer and urologic oncology.
Next I would like to ask Dr. <unk> to update you.
You on end of year, one and the new six months follow up data.
Reg is an accomplished urology expert robust clinical experience in the development of novel therapy for non muscle invasive bladder cancer.
Speaker #7: Dr. Raj Puthi, Chief Medical Officer, Oncology, and Dr. Jay Lothan, Chair of our Clinical Advisory Board. We believe their contributions will be instrumental to our success.
Rod how are you.
Thank you Sergio and good afternoon, everyone IMAX.
I'm excited to be part of the <unk> team.
This afternoon I'm pleased to provide a brief overview of <unk> and chair of the positive six months follow up data from our phase two open label study in patients with high grade non muscle invasive bladder cancer.
Speaker #7: And fourth, we have made significant progress toward our objective of bringing each program to patients as soon as possible with preparation underway to begin the next set of studies for NDV01 and separalonin in 2026.
There are about 85000, new cases of bladder cancer diagnosed each year in the United States and 600000 people in the U S who are living with bladder cancer.
Speaker #7: With two promising product candidates, an expanded management team and clinical advisory board, a 20.6 million cash balance, and a lean balance sheet, I believe Relmada is well-positioned to take the next value-creating steps for each program.
About 50% of new cases of bladder cancer have high grade disease that is a high risk of recurrence and potentially progression.
Speaker #7: Next, I would like to ask Dr. Puthi to update you on NDV01 and the new six-month follow-up data. Raj, he's an accomplished urology expert with clinical experience at Bass in the development of novel therapy for non-muscle invasive bladder cancer.
I joined <unk>, because I believe that <unk>, one has the unique potential that become a class leading bladder sparing therapy for <unk>.
This is an exciting time for our patients.
<unk> hundred one is a novel sustained release intra vesicle formulation to chemotherapy agent Gemcitabine and Docetaxel or Jim don't see Enrique.
Speaker #7: Raj, how are you?
Speaker #8: Thank you, Sergio, and good noon, everyone. I'm excited to be part of the Relmada team. This afternoon, I'm pleased to provide a brief overview of NDV01 and share the positive six-month follow-up data from our phase two open-label study in patients with high-grade non-muscle invasive bladder cancer.
It was designed to build on data from over the past decade from academic centers showing that combination use of these two agents achieved response rates and recurrence free survival that were comparable to or better than their historical standard of care BCG.
Speaker #8: There are about 85,000 new cases of bladder cancer diagnosed each year in the United States. And 600,000 people in the US living bladder cancer.
And for those who are unresponsive to BCG. It can provide an effective second line option to avoid detected.
Speaker #8: About 50% of new cases of bladder cancer have high-grade disease. That is a high risk of recurrence and potentially progression. I joined Relmada because I believe that NDV01 has the unique potential to become a class-leading bladder-sparing therapy for NMIBC.
The sustained release formulation of N D V O. One is intended to accomplish our objectives.
Prolonged bladder exposure to Jim Darsey.
Second to minimize systemic toxicity.
Third to overcome cumbersome handling and preparation.
Speaker #8: This is an exciting time for our patients. NDV01 is a novel sustained-release intravesical formulation of two chemotherapy agents, Docetaxel, or Gemdosi as we say.
And fourth to simplify administration decreasing the burden to patients and providers.
<unk> has provided to study sites and are ready to use dose that can be administered in the office and less than 10 minutes without the need for a specialized pharmacy biocontainment hood, our newer dedicated equipment.
Speaker #8: It was designed to build on data from over the past decade from academic centers showing that combination use of these two agents achieved response rates and recurrence-free survival that were comparable to or better than the historical standard care BCG.
Moving to the Phase III study and <unk> is being evaluated in a single arm single Center ex U S clinical trial in patients with high risk and B C.
Speaker #8: And for those who are unresponsive to BCG, it can provide an effective second-line option to avoid cystectomy. The sustained-release formulation of NDV01 is intended to accomplish four objectives.
Patients are treated with <unk> and a biweekly induction phase.
Led by a monthly maintenance for up to one year with regular assessments done with cystoscopy cytology.
And if needed biopsies.
Speaker #8: First, prolonged bladder exposure to Gemdosi. Second, to minimize systemic toxicity. Third, to overcome cumbersome handling and preparation. And fourth, to simplify administration, decreasing the burden to patients and providers.
The phase III study was designed to enroll up to 70 subjects with localized non metastatic high risk <unk>.
The primary endpoints are safety and complete response or CR at 12 months secondary efficacy endpoints or duration of response and event free survival.
Speaker #8: NDV01 is provided to study sites in a ready-to-use dose that can be administered in the office in less than 10 minutes. Without the need for a specialized pharmacy biocontainment hood or newer dedicated equipment.
Efficacy assessments for the six month follow up included analysis of the data at six months and at any time point.
These are the same safety and efficacy parameters that were applied to the three month data that were presented at the American Urology Association meeting in April.
Speaker #8: Moving to the phase two study, NDV01 is being evaluated in a single-arm, single-center XUS clinical trial in patients with high-risk NMIBC. Patients are treated with NDV01 in a bi-weekly induction phase followed by a monthly maintenance for up to one year with regular assessments done with cystoscopy, cytology, and if needed, biopsy.
For the six month efficacy assessment, we observed.
A complete response rate of 90%.
Based on 21 patients at six months.
Looking at the data at any time point, we observed a complete response rate of 91% or two.
Our 23 patients at any time.
Ah patients with BCG unresponsive disease, we see an 88% T or any time.
Speaker #8: The phase two study was designed to enroll up to 70 subjects with localized non-metastatic high-risk NMIBC. The primary endpoints are safety and complete response or CRR at 12 months.
And in carcinoma in situ or CIS patients, we see 100% CR anytime.
The assessment of disease free status at six months showed that again, 90% of the 21 evaluable patients achieved disease free status at the six month assessment.
Speaker #8: Secondary efficacy endpoints are duration of response and event-free survival. Efficacy assessments for the six-month follow-up included analysis of the data at six months and at any time point.
This is based on the 29 patients enrolled which include Kevin with concomitant T I S.
Speaker #8: These are the same safety and efficacy parameters that were applied to the three-month data that were presented at the American Urologic Association meeting in April.
Two with papillary disease that is T. A R. A T. One.
In this study five of these patients have been re induced cohort.
At three months and one at six months.
Speaker #8: For the six-month efficacy assessment, we observed a complete response rate of 90% based on 21 patients at six months. Looking at the data at any time point, we observed a complete response rate of 91% or 23 patients at any time.
<unk> continues to demonstrate favorable safety.
At the six month follow up there were no treatment related adverse events greater than grade three.
The most common treatment related adverse events were urinary this area.
And hematuria with hematuria only seen in 4% of the patients the.
Speaker #8: Of patients with BCG unresponsive disease, we see an 88% CR any time. And in carcinoma in situ or CIS patients, we see a 100% CR any time.
The majority of the patients with this area were grade one and resolved within 24 hours.
No patients had treatment discontinuation is related to adverse events.
Speaker #8: The assessment of disease-free status at six months showed that, again, 90% of the 21 evaluable patients achieved disease-free status at the six-month assessment. This is based on the 29 patients enrolled which include seven with concomitant CIS, 22 with papillary disease, that is TA or T1, in the study, five of these patients have been reinduced four at three months and one at six months.
These durable six month follow up data are consistent with our expectations and with the known efficacy of Gen doses.
The results reported today raise our confidence and the potential for <unk>.
A promising effective safe and durable treatment for non muscle invasive bladder cancer.
Our goal is to bring <unk> to patients as soon as possible.
We intend to initiate a phase III study for <unk> in the first half of 2020.
Speaker #8: NDV01 continues to demonstrate favorable safety. At the six-month follow-up, there were no treatment-related adverse events greater than grade three. The most common treatment-related adverse events were urinary dysuria, and hematuria, with hematuria only seen in 4% of the patients.
Our efforts in the coming months will be focused on completing study preparations, including plans to interact with their food and drug administration on our proposed trial design and transfer of production to a contract manufacturer to complete scale up in production of clinical batches.
Speaker #8: The majority of the patients with dysuria were grade one and resolved within 24 hours. No patients had treatment discontinuations related to adverse events. These durable six-month follow-up data are consistent with our expectations and with the known efficacy of Gemdosi.
Now I'd like to turn the call over to our Chief Financial Officer Mac in Trinidad to talk more about subprime alone in our financial results.
Thank you Raj.
Spend a few minutes on Japan alone and then provide you with an overview of our second quarter financial results.
So <unk> is a member of the new subgroup of newer sterns comp Gam says, we're again gambro modulating steroid impact.
Speaker #8: The results reported today raise our confidence in the potential for NDV01 as a promising, effective, safe, and durable treatment for non-muscle invasive bladder cancer.
We believe soprano loans novel action on the Gaba neurotransmitter pathways gives me a unique potential to alleviate the repetitive symptoms and disorders, where compulsive behaviors are common feature.
Speaker #8: Our goal is to bring NDV01 to patients as soon as possible. We intend to initiate a phase three study for NDV01 in the first half of 2026.
These disorders affect millions of people in the U S and around the world and.
And include indications, such as <unk>, Willi syndrome, and Tourettes syndrome.
Speaker #8: Our efforts in the coming months will be focused on completing study preparations including plans to interact with the Food and Drug Administration on our proposed trial design and transfer production to a contract manufacturer to complete scale-up and production of clinical batches.
We have selected <unk> Willi syndrome, or <unk> is the first clinical indication that we will evaluate with super analog.
It affects approximately 350000 people worldwide.
Inclusive, including approximately 20000 people in the U S.
Speaker #8: Now, I'd like to turn the call over to our chief financial officer, Maged Shenouda, to talk more about separalonin and our financial results. Maged?
<unk> is a complex genetic disorder, often defined by persistent hunger and overeating.
Current treatment is focused on improving the obsessive compulsive.
Speaker #9: Thank you, Raj. I'll end a few minutes on separalonin and then provide you with an overview of our second quarter financial results. Separalonin is a member of a new subgroup of newer steroids called Gamsus, or GABA modulating steroid antagonists.
<unk> and other medical complications that characterize this disorder.
Phase III data from a phase from a study in patients with Tourette's syndrome provided proof of concept for <unk> mechanism of action and compulsive disorders and demonstrated that the compound is good overall tolerability.
Speaker #9: We believe separalonin's novel action on the GABA neurotransmitter pathway gives it unique potential to alleviate the repetitive symptoms and disorders where compulsive behaviors are a common feature.
We intend to initiate a proof of concept or proof of concept study and PWM and the first half of 2026.
Speaker #9: These disorders affect millions of people in the US, and around the world, and include indications such as Prader-Willi syndrome and Tourette's ndrome. We have selected Prader-Willi syndrome, or PWS, as a first clinical indication that we will evaluate with separalonin.
Our efforts in the coming months will be focused on completing study preparations, including plans to interact with the FDA proposed trial design.
And setting up our product supply chain, including contract manufacturers.
Speaker #9: It affects approximately 350 thousand people worldwide. It includes approximately 20 thousand people in the US. PWS is a complex genetic disorder often defined by persistent hunger and overeating.
Moving now to our financials.
We believe our disciplined development strategy and two promising innovative product candidates have significantly enhanced real modest pipeline and long term value proposition.
We think we're poised to make excellent progress in our upcoming milestones through the end of this year and beyond.
Speaker #9: Current treatment is focused on improving the obsessive-compulsive behaviors and other medical complications that characterize this disorder. Phase two data from a phase from a study in patients with Tourette's ndrome provided proof of concept for separalonin's mechanism of action in compulsivity disorders and demonstrated that the compound has good overall tolerability.
As noted by Brian. This afternoon, we issued a press release announcing our business and financial results for the second quarter ended June 32025.
As of June 32025, real Mato had cash cash equivalents and short term investments of approximately $26 million.
Compared to $44 $9 million as of December 31, 2024.
Speaker #9: We intend to initiate proof of concept or proof of concept study in PWS in the first half of 2026. Our efforts in the coming months will be focused on completing study preparations including plans to interact with the FDA on our proposed trial design.
Cash used in operations in the second quarter ended June 32025 was $6 4 million compared.
Compared to $13 3 million for the same period in 2024.
Speaker #9: And setting up our product supply chain including contract manufacturers. Moving now to our financials. We believe our discipline, development strategy, and two promising innovative product candidates have significantly enhanced Relmada's pipeline and long-term value proposition.
Looking ahead we.
We are prioritizing the advancement of <unk>.
As we advance our clinical and regulatory strategy for each program, we expect to have a line of sight to our cash requirements and runway.
During today's call I will review the second quarter 2025 financial results information regarding the six month results are included in our press release and 10-Q issued this afternoon.
Speaker #9: We think we are poised make excellent progress in our upcoming milestones through the end of this year and beyond. As noted by Brian, this afternoon we issued a press release announcing our business and financial results for the second quarter ended June 30, 2025.
Research and development expense for the second quarter, 2025 totaled $2 $8 million compared to $10 7 million for the second quarter of 2024, a decrease of $7 $9 million.
Speaker #9: As of June 30, 2025, Relmada had cash, cash equivalents, and short-term investments of approximately $20.6 million, compared to $44.9 million as of December 31, 2024.
The lower spend was primarily.
Driven by lower study cost with the wind down of clinical trials for <unk> 17, partially offset by an increase in costs associated with the ramp up of <unk> and soprano loan activities and an increase in R&D employee compensation.
Speaker #9: Cash use and operations in the second quarter ended June 30, 2025, was 6.4 million dollars compared to 13.3 million dollars for the same period in 2024.
General and administrative expense for the second quarter 2025 totaled $7 4 million.
Speaker #9: Looking ahead, we are prioritizing the advancement of NDV01. As we advance our clinical and regulatory strategy for each program, we expect to have a line of sight to our cash requirements and runway.
Compared to $8 $1 million for the second quarter of 2024 a.
A decrease of approximately $696000.
The decrease was primarily driven by a decrease in stock based compensation expense, partially offset by an increase in employee and consulting service costs.
Speaker #9: During today's call, I will review the second quarter 2025 financial results. Information regarding the six-month results are included in our press release and 10Q issued this afternoon.
The net loss for the second quarter of 2025 was $9 9 million or <unk> 30 per basic and diluted share compared with a net loss of $17 8 million or <unk> 59 per basic and diluted share for the second quarter of 2024.
Speaker #9: Research and development expense for second quarter 2025 totaled 2.8 million dollars compared to 10.7 million dollars for the second quarter of 2024. A decrease of 7.9 million dollars.
Before we open the call for questions I will turn back to Sergio for some closing comments Sergio.
Speaker #9: The lower spend was primarily driven by lower study costs, with a wind-down of clinical trials for REL1017, partially offset by an rease in costs associated with the ramp-up of NDV01 and separalonin activities and an increase in R&D employee compensation.
Thank you Maggie.
I'd like to leave you with these key messages from today's call.
2025 is off to a strong start for in our model.
First.
We are excited about our innovative new programs <unk> hundred one for non muscle invasive bladder cancer or <unk> four combo CVT disorder.
Speaker #9: General and administrative expense for the second quarter 2025 totaled 7.4 million dollars. Compared to 8.1 million dollars for the second quarter of 2024. A decrease of approximately 696 thousand dollars.
Yeah, well aligned with our strategic objectives and second.
We are pleased to report that the six months follow up from the Phase two study of our <unk> produce impressive response rate with 91% of high risk patients achieving disease free status anytime point following <unk> treatment.
Speaker #9: The decrease was primarily driven by a decrease in stock-based compensation expense partially offset by an increase in loyee and consulting service costs. The net loss for the second quarter of 2025 was 9.9 million dollars or 30 cents per basic and diluted share.
Third we have expanded our team we get additional two highly respected expert in bladder cancer and Urologic oncology the rush prudent as Chief Medical Officer oncology and both Toyota is chair of advisors clinical Advisory Board.
Speaker #9: Compared with a net loss of 17.8 million dollars or 59 cents per basic and diluted share for the second quarter of 2024. Before we open the call for questions, I will turn back to Sergio for some closing comments.
Speaker #9: Sergio?
I believe that their contribution would be instrumental to our success.
Speaker #10: Thank you, Maged. I'd like to leave you with these key messages from today's call. 2025 is off to a strong start for Relmada. First, we are excited about our innovative new programs NDV01 for non-muscle invasive bladder cancer or NMIBC and separalonin for compulsivity disorder.
And fourth.
We are preparing to begin a phase III study for <unk> one in the first half of 2026 in addition.
We expect to initiate the phase two study with <unk> in <unk> Willi syndrome also in 2026.
With two promising product candidates and expanded management team and clinical advisory board $26 million in cash balance and a clean balance sheet, we believe it or not as well positioned to take the next value creating steps for each program.
Speaker #10: They are well aligned with our strategic objectives. And second, we are pleased to report that the six-month follow-up from the phase two study of NDV01 produced impressive response rates.
With our progress in terms of our gratitude for your support and for taking time to join the call today.
Speaker #10: With 91% of high-risk patients achieving disease-free status at any time point following NDV01 treatment. Third, we have expanded our team with the addition of two highly respected expert in bladder cancer and urologic oncology.
We look forward to updating you on our continued progress throughout the year.
Operator.
Now I would like to open the call for a discussion.
Questions.
Speaker #10: Dr. Raj Puthi, as chief medical officer oncology, and Dr. Jay Lothan, as chair of advisor clinical advisory board. We believe that their contribution will be instrumental to our success.
Thank you, ladies and gentlemen, as a reminder, if you would like to ask a question. Please press star one on your telephone keypad at this time.
Our first question is coming from the line of all year with Mizuho Securities. Please proceed with your question.
Speaker #10: And fourth, we are preparing to begin a phase three study for NDV01 in the first half of 2026. In addition, we expect to initiate a phase two study with separalonin in Prader-Willi syndrome, also in 2026.
Hey, guys.
Congrats on the six months data it looks very very encouraging.
So.
Maybe just help us understand what the data at hand, and also the recent approval.
Speaker #10: With two promising product candidates and expanded management team and clinical advisory board, 20.6 million in cash balance and a clean balance sheet we believe Relmada is well-positioned to take the next value-creating steps for each program.
That your origin got for their product just help us.
Hum how do these factors.
These events factor into your thinking is with respect to in D. V. Zero one going forward are you see more focus on high grade ore.
Speaker #10: With our progress, comes our gratitude for your support and for taking time to join the calls today. We look forward to updating you on our continued progress throughout the year.
Moving sort of away from that to maybe a larger market in Alaska backup market.
Great.
Non invasive bladder cancer.
Speaker #10: Operator, I will now like to open the call for discussion. For questions.
So that's the first question and the second question is I guess, when you're meeting with the FDA like what maybe they're related.
Speaker #5: Thank you. Ladies and gentlemen, as a reminder, if you would like to ask a question, please press star one on your telephone keypad at this time.
What are you what are you hoping to accomplish.
Speaker #5: Our first question is coming from the line of Oier with Mizuho Securities. Please proceed with your estion.
There and like what sort of data will you present.
As well.
Speaker #11: Hey, guys. Yeah, congrats on the six-month data. It looks very, very encouraging. So maybe just help us understand, you know, what the data at hand and also the recent approval that EuroGen got for their product.
Just.
Yeah.
With these two questions for now thanks.
So thank you all for the questions I believe Rajiv the right person to answer your questions Raj.
Yes, Thank you and.
Speaker #11: Just help us out. You know, how do these factors or events factor into your thinking with respect to NDV01 going forward? Are you more focused on high grade, or are you moving sort of away from that to maybe a larger market and less competitive market?
I think your first question is what.
What is the best approach is at high risk.
Which I shared with you the very exciting data or is that at your gen type of approach with low grade intermediate risk cutting with the questions and I'll address that first I think the second one is regarding <unk>.
I think you bring up a great question as far as the.
Speaker #11: And non-high grade. Non-invasive bladder cancer. So that's the first question. And the second question is, I ess, when you are meeting with the FDA, like at maybe they're ated, what are you, you know, what are you hoping to accomplish there and what sort of data will you present as well?
Our go forward strategy I think you outlined it perfectly that theres, a great opportunity and low grade intermediate risk the incident and prevalent population is very large theater patients, who don't just develop new tumors each year, but they recur they recur at about a rate of 50% so that prevalent population increases.
And the burden of <unk> resection of bladder tumor.
Speaker #11: Yeah, I'll stay with these two questions for now. Thanks.
Ah patient bears.
Your Gen with there.
Approval earlier this year set a.
Speaker #12: Sergio here. Thank you all for the questions. I believe Raj is the right person to answer your questions. Raj?
An excellent precedent of a single arm open label study in this space.
Getting approval.
Speaker #8: Yes. Thank you. And I think your first question is what, you know, what is the best approach? Is it high risk, which I shared with you the very exciting data, or is it a Eurogen type of approach with low-grade intermediate risk?
And this will lead into a conversation. So I think that is an excellent opportunity for any chemo ablative agent and I think we're seeing chemo ablation become a much more.
Replacing Torb tea, which there are about $100 and performed each year become much more attractive alternative to support clinicians and desired by patients.
Speaker #8: I think was the question. And I'll address that first. I think the second was regarding the FDA. I think you bring up a great question as far as the go-forward strategy.
So I think that is an excellent opportunity however, with the data we shared with you the efficacy and high grade disease. It is also significant and one that we will continue to generate clinical evidence for for urologists have in hand, and perhaps for <unk> guidelines inclusion.
Speaker #8: I think you outlined it perfectly that there's a great opportunity in low-grade intermediate risk. The incident and prevalent population is very large. These are patients who don't just develop new tumors each year, but they recur, they recur at about a rate 50%.
The FDA pathway for that is is also clear that is what part 200 are Ed stelmach doing with Ferring <unk> Keytruda others have.
Speaker #8: So the prevalent population increases and the burden of TURBT or transurethral resection of bladder tumor is what the patient bears. I ink Eurogen with their approval earlier this year set a excellent precedent of a single-arm open-label study in this space getting approval.
Our pursuing her and C G or have achieved it.
It's a tougher group of patients, it's a smaller group of patients and it's a little bit tougher to enroll because these are often BCG unresponsive with Cif. So again much smaller patient population, but I think we have the clinical data to show that were effective and high risk disease. So I think there's two opportunities that you outlined.
Speaker #8: And this will lead into a versation FDA. So I think that is an excellent opportunity for any chemo ablative agent. And I think we're seeing chemo ablation become a much more replacing TURBT, which there are about 100,000 performed each year, become a much more attractive alternative for clinicians and desired by patients.
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To your second question is what are we what we ask the FDA is I think one of the main questions. It will be a conversation.
Speaker #8: So I think that that is an excellent opportunity. However, with the data we shared with you, the efficacy in high-grade disease is also significant.
Is that your Gen path.
There is precedent for it which they did earlier this year a viable path for us forward.
A single arm open label study in chemo ablation that'll be our main question with them.
Speaker #8: And one that we'll continue to generate clinical evidence for for urologists to have in hand and perhaps for guidelines inclusion. The FDA pathway for that is also clear.
I hope I addressed your questions, yes, maybe.
And as a follow up it's possible. So if you have to sort of.
Speaker #8: That is what TAR 200 or it's still adjourned with fairing or Antiva Keytruda others have are pursuing her and CG or have achieved. It's a tougher group of patients.
Between.
The data that you have in hand, and which is in high grade and what you would like to move in or potentially a better opportunity, which is the low to intermediate grade.
Speaker #8: 's a smaller group of patients. And it's a little tougher to enroll because these are often BCG unresponsive with CIS. again, much smaller patient population.
Where do you sort of see more risks, maybe just help us understand like what gives you confidence to move into the low to intermediate grade.
Speaker #8: But I think we have the clinical data to show that we're ective in high-risk disease. So I think there's two opportunities that you outlined.
Great question, I think that conversation with the FDA will be very important.
Speaker #8: Both which fit very well with NDV01. To your second question is what are we what will we ask the FDA? I think one of the main questions will be a conversation of, you ow, is the Eurogen path that there's precedent for it, it did earlier this year, a viable path for us forward?
To do that I think another attractive why that's another attractive option as I think we think that there that has a faster opportunity to FDA approval.
You accrue to those trials much more rapidly.
The low grade intermediate patients there is much more of them. So I think thats, a faster path to FDA approval and to get this into urologist hands.
Speaker #8: For a single-arm open-label study and chemo ablation. That'll be our main question with them. I hope I addressed your questions.
The the risks comes in.
One study before and Thats, what Youre adjourn the positive that as if it was approved and it was this year, but I think the FDA will help us make that decision.
Speaker #11: Yeah. So maybe I can ask a follow-up if it's possible. So if you have to sort of look between you know the data that you have in hand, and which is in high grade, and what you would like to move, and or you ow potentially a better opportunity which is the low to intermediate grade, where do you sort of see more risks?
Okay.
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That's another question if I may.
How should we kind of sort of think about R&D.
Going forward you know just the LNG has dropped.
Speaker #11: Maybe just help understand like at would give you confidence to move into the low to intermediate grade?
Meaningfully.
I understand why I guess, you were trying to conserve cash to prioritize and D V zero to one.
Speaker #8: Great question. I think that that conversation with the FDA will be very important. to do that. I think another attractive why that's another attractive option is I ink we think that there that is a faster opportunity to FDA approval.
Yeah, maybe maybe a.
So Joe maybe I should answer that well.
The R&D expense went down because we are not enrolling patients the because of R&D is is enrolling patients.
Speaker #8: I think you you accrue to those trials much more rapidly. In in the low-grade intermediate patients, there's much more of them. So I think that's a faster path to FDA approval and to get this into urologists' hands.
We are planning to do that as soon as we start the phase II is a problem on an end of phase III in India. One in the first half of next year. So until then the cost is is reduced because its manufacturing getting ready dialog with the FDA that these are not expensive.
Speaker #8: The risk comes in. We have one study before, and that's with Eurogen. The positive of that is it was approved, and it was this year.
Activities.
Speaker #8: But I ink the FDA will help us make that decision.
So the darn thing that because the cost of R&D went down the <unk>.
Speaker #11: Okay. Another question if I may. You know how should we kind of sort of think about R&D going forward? You know this the R&D has dropped meaningfully.
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We have well enough resources financial to do what is needed to do now and now the expense will go up when we start to enroll patients.
Okay. Thank you.
Thank you Lee.
Thank you ladies and gentlemen, this does conclude our question and answer session and our call for today. We thank you for your participation and you may disconnect. Your lines at this time.
Speaker #11: Understandably, I ess you're trying to conserve cash to prioritize NDV01.
Speaker #8: Yeah. Maybe Sergio, maybe I should answer that. Well, the R&D expense went down because we are not enrolling patients. The big cost of R&D is enrolling patients.
Yes.
Speaker #8: And we're planning to do that as soon as we start both the phase two and separalonin and the phase three in NDV01 in the first half of next year.
Speaker #8: So until then, the cost is is reduced because it's manufacturing, getting ready, dialogue with the FDA that these are not expensive activities. So don't think that because the cost of R&D went down, the activity also slowed down.
Speaker #8: We have well enough resources, financial, to do what is needed to do now. And you ow the expense will go up when we start to enroll patients.
Speaker #11: Okay. Thank you.
Speaker #8: Thank ou, Oi.