Relmada Therapeutics Inc (RLMD) 2024 Q3 法說會逐字稿

Hello and welcome to the Relmada Therapeutics third quarter, 2024 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 location website.

I would now like to turn the call over to Tim mccarthy from lifesci advisors. Please go ahead Mr mccarthy.

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 months ended, September 30th 2024.

Please note that certain information discussed on the call today is covered under the safe harbour provision of the private securities Litigation Reform Act.

We caution listeners that during this call, Relmadas 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 real modes press release issued today and the company's sec filings including in the annual report on form 10-K for the year ended December 31st 2023 and the subsequent filings including the third quarter, 2024 10-Q 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. November 7th 2024.

Ramada 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 Relmadas CEO Dr Sergio Traversa, who will briefly provide a summary of recent business highlights and Relmadas CFO Maggie Shea who will provide 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 Traversa, Sergio.

Thank you Tim and good afternoon and welcome everyone to the Ramada third quarter, 2024 conference call.

Another number one priority is to advance the development of new treatments for CNS disorder including major depressive disorder MD.

Our number one objective is to successfully complete the phase three program and the ND A package for route 1,017 or met with laser focus on derisking the study design and execution.

We expect to report the outcome of the interim analysis for the reliance to phase three study by year end 2024 and believe that this could potentially be an important de risking event for the study and the real 1,017 program. And the company, as a reminder with Red 17, we aim to provide patients with MD D A new adjunctive treatment option to be used in combination with their current regimen.

Approximately 10 million people were treated for a major depressive episode in the last year and 40% of this patient that is about 4 million people require combination therapy. This is us only.

Our phase three registrational program has been designed to build on key learnings from our previously conducted phase three and phase two programs in today's call. I will focus on well 1,017 and also provide a brief update on our silo cybin based metabolic disease program.

After that maggot will review our financial results and then we will take your questions.

The clinical program for E 1,017 is comprised of two studies. Reliance to Andrei as a reminder. Each study was designed as a double blinded placebo control randomized phase three registration or clinical trial to evaluate R 1,017 inpatient with clinical depression.

We are on track to provide the outcome of the planet sample size reestimation. Interim analysis for the reliance to study. By your end of 2024 there are three potential outcomes based on the D MC Data Management Committee. Recommendations from the Unblind and Interim analysis.

The first potential outcome is that the study can continue with the preplanned number of patients.

This is of course our preferred outcome and the basis of a top line data readout in the first half of 2025.

The second potential outcome would be a recommendation to continue the study with the addition of more patients.

This would indicate that the promising efficacy signal was observed with the interim data and that an increased sample size is required to improve the power of the final analysis.

We would view this as an encouraging signal from the study and worth the time and cost to attend enrolment.

The third potential outcome is that the study is deemed to be futile.

It is important to note that we set the futility level such that a clinically meaningful result in the final analysis would be highly unlikely. Specifically, it translates to a drug placebo delta below approximately 2.2 points.

The outcome of these scenarios will provide a clear indication of how the study is going and we do believe that this will be an important the risky event for around 1,017.

Before I ask NGG to review the financial results, I will provide a brief update on the silo tying program for metabolic disease.

The phase one safety study from our investigational candidate RP 11 is screening subject and we expect the first randomization basin.

The study will be conducted in Canada with obese individuals and will allow us to define the pharmacokinetics safety and tolerability profile. For a single dose of 11 and select the optimal dose or doses for evaluation in a phase two, a proof-of-concept study.

We do expect to begin the phase two a study in 2025.

Now we turn the call to our CFO Maged.

Sure. Thank you, Sergio. As noted by Tim this afternoon, we issued a press release announcing our business and financial results for the third quarter ended September 30 2024 during today's call. I'll provide a brief overview of the financials. Full details are available in our press release and the one Q filing we completed today. These documents are available on our website in the news and SEC filings tabs on the investor relations page.

As of September 30 2024 Ramada had cash, cash equivalents and short-term investments of approximately $54.1 million compared to $96.3 million. As of December 31 2023 cash use in operations in the third quarter ended September 30 2024 was $16.7 million compared to $11.6 million for the same period in 2023.

Based on our current plan for clinical development, we expect our current cash position to support operations through key near term milestones into 2025.

Moving through the rest of the financial results, total research and development expense was approximately $11.1 million as compared to $10.5 million for the comparable period of 2023 an increase of approximately $0.6 million.

The increase was primarily associated with the ramp up of expenses related to the 302 and 304 studies. In 2024 the non-cash charge related to stock-based compensation for R&D totalled $1.7 million in the third quarter of 2024.

Total general and administrative expense for the third quarter was approximately $11.9 million as compared to $12.2 million for the comparable period of 2023. A decrease of approximately $0.3 million. The decrease was primarily driven by a decrease in stock based compensation expense.

An on cash charge related to stock based compensation expense four G&A totalled $6.2 million in the third quarter of 2024.

The net loss for the third quarter of 2024 was $21.7 million or 72¢ per basic and diluted share compared with a net loss of $22 million or 73¢ per basic and diluted share in the comparable period of 2023.

Note that the company had 30.2 million common shares outstanding as of November for 2024.

Before we open the call for questions, I'll turn back to Sergio for some closing comments. Sergio.

Thank you, Megan.

I would like to leave you with these key messages from today's call Relmadas. Number one objective is to complete the phase three program and the ND A package for R 1,017, we expect to report the results outcomes of the pre-planned interim analysis for the reliance to face this study by year end 2024. And we do believe that this could be an important de risking event for the study. And the real 1,017 program, we plan to enroll the first subject in the phase one single agent study dosing study for P 11 in development for metabolic disease. Very soon.

With that said, we can open the question operator.

Thank you as a reminder. If you would like to ask a question, please press star one on your telephone keypad one moment please. For your first question.

Our first question comes from the line of Andrew Tsai from Jeffries. Please go ahead.

Hey, good afternoon and thanks for taking my questions. Thanks for the updates. First question is what exactly can we expect you to say in the interim release? Will it, will it be just a few sentences, or could it be something more detailed than that?

Yeah. Hi, Andrew. Thanks for the question. It's Sergio here. Well, yeah, the, it, it's difficult to do it to decide in advance it really. Now we'll, we'll see what the outcome will be and if there is any need for like go more in detail, we may have a call or if it is a straightforward message, then we may not, but we will have to wait. So what we can share is that we will give as many details as we can on the, on the outcomes.

Got it. You will know what the B MC will tell us.

Mm okay. And I heard 2.2 points somewhere earlier in your prepared remarks. But is that for statistical significance just be just to clarify?

Yes. Thanks Andrew. No, it was I it was 2.0.

I read two twice. So it's about around two points deltas. And I we say approximately because it depends, of course from the standard deviation.

So it can be slightly higher, slightly lower than two.

Got it. And then what threshold are you setting for the utility? What kind of placebo address at delta below what placebo address at delta? Will you hit futility?

Yeah. Is the, is the, is the same number and about two points. So two points is kind of the threshold between clinical and non-clinical significance. So we would like if we had a product, we would like to, to be sure that it is also clinically meaningful.

So it's about two points. So below two points plus minus a little bit due to the standard deviation. If it is below two points, it's probably going to be file.

Very clear. Okay. Thank you and good luck on everything.

Thank you. And I'll proceed.

Our next question comes from the line of Mark Goodman at Leerink Partners. Please go ahead.

Hi, good afternoon. This is Basma on for Mark. Thank you for taking our question regarding the interim readout. Are you going to be able to have access to any other information such as baseline characteristics of the patients or [unli] in data of matters, changes for instance, or is it mainly going to be the information related to the facility or not? Thank you.

Yeah, thanks for the question. No, we will only know what the, the data management committee will share with us that is pretty much like the three outcomes. They won't provide any additional any additional colour or you know, details. They, they, the A B MC and we want to maintain the, the integrity of the data. So we will only know like if it is futile, we can continue as planned or if we need to add patients to increase the power. That's it.

Thank you. That's very clear. Thank you.

Our next question comes from the line of Oe from Mizuho. Please go ahead.

Hi, thanks for taking my question. It's Charles on for oil.

So I was curious if the DFC recommends no change. Would you continue to enrol to 300 or would that be that 400 or 340 number. Men. Yeah, thank you.

Yeah. Hi. Hi Charles. Well, that would be the best outcome, but it, it's difficult to give a straight answer.

Technically. Usually you tend to enrol a little bit more than the, like the plan number, like maybe a few percent more just to be sure to account for the, the dropouts and, and, but, you know, the, the, the plan number is, you know, north of 300 between three and 340. So it's going to be around that number.

Okay. Thanks.

For taking my question.

Our next question comes from the line of Andrea Newark from Goldman Sachs. Please go ahead.

Hi team. This is Tala on for Andrea. Thanks for taking our questions. Two from us. First, from a statistical perspective, can you confirm you're not taking a hit to alpha by conducting the interim analysis? And then secondly, just wondering if you have any updates on the percent screen failure rates and reliance to compare to those from the prior studies. Thanks.

Yeah, sure. I can confirm that there is no alpha penalty paid in the interim analysis and the reason being that there is no early stop. So it's not an efficacy, an efficacy interim analysis. So we there is no plan to stop the trial early. The best-case scenario is to continue as planned.

And this one and the second one was the dropout rate, and it is it is low, right? It is in the single digit; mid-single digit and it is lower than in the previous trial. But, you know, I, I would be cautious everyone to read anything into that.

It just means that there is like compliance and that the, the idea of the, the, the patient in the trial is good. So I would not translate anything from that in, in term of efficacy or something like that. It's about like mid-single digit.

That's helpful. Thank you.

Thank you.

There are no further questions at this time. I'd now like to turn the call over to Sergio Traversa for final closing comments.

Thank you. And in closing, as we get ready to read out on a very important upcoming clinical milestones or relative 17 as a potential adjunct treatment for MD D.

We want to thank you everyone for your support and for taking time to join the call today. Thank you and have a wonderful rest of the day.

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