Relmada Therapeutics Q3 2024 Earnings Call Transcript

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November 7, 2024

There are 7 speakers on the call.

Operator

Hello, and welcome to the Realmata 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. 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.

Operator

Please go ahead, Mr. McCarthy.

Speaker 1

Good day, everyone, and thank you for joining us today. This afternoon, Ramada issued a press release providing a business update and outlining its financial results for the 3 months ended September 30, 2024. 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, Remada's management team will be making forward looking statements. Actual results could differ materially from those stated or implied by these forward looking statements due to risks and uncertainties associated with the company's business.

Speaker 1

These forward looking statements are qualified by the cautionary statements contained in Ramada's press release issued today and the company's SEC filings, including in the annual report on Form 10 ks for the year ended December 31, 2023, and subsequent filings, including the Q3 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 7, 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 Ramada's CEO, Doctor. Sergio Traverza, who will briefly provide a summary of recent business highlights and Ramada's CFO, Magda Shanuta, who will provide a review of the company's Q3 financial results.

Speaker 1

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

Speaker 2

Thank you, Tim, and good afternoon, and welcome, everyone, to the Q3 2024 Conference Call. Renata's number one priority is to advance the development of new treatments for CNS disorders, including major depressive disorder, MDD. Our number one objective is to successfully complete the Phase III program and the NDA package for RAL1017 or S methadone with a laser focus on derisking the study design and execution. We expect to report the outcome of the interim analysis for the RELIANCE II Phase III study by year end 2024 and believe that this could potentially be an important de risking event for the study and the rel=ten seventeen program and the company. As a reminder, with rel=ten seventeen, we aim to provide patients with MDD a new adjunctive treatment option to be used in combination with their current regimen.

Speaker 2

Approximately 10,000,000 people were treated for a major depressive episode in the last year, and 40% of these patients, that is about 4,000,000 people, require combination therapy. This is U. S. Only. Our Phase III registrational program has been designed to build on key learnings from our conducted Phase III and Phase II programs.

Speaker 2

In today's call, I will focus on rel=ten seventeen and also provide a brief update on our psilocybin based metabolic disease program. After that, Magid will review our financial results, and then we will take your questions. The clinical program for RELS1017 is comprised of 2 studies, RELIANCE 2 and RELIGHT. As a reminder, each study was designed as a double blinded, placebo controlled, randomized, Phase 3 registrational clinical trial to evaluate rel1017 in patient with clinical depression. We are on track to provide the outcome of the planned sample size re estimation interim analysis for the RELIANCE 2 study by year end 2024.

Speaker 2

There are 3 potential outcomes based on the DMC Data Management Committee recommendations from the unblinded 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 twenty twenty five. The second potential outcome would be a recommendation to continue the study with the addition of more patients. This would indicate that a 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.

Speaker 2

We will view this as an encouraging signal from the study and worth the time and cost to extend enrollment. The 3rd 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 how the study is going, and we do believe that this will be an important derisking event for rel=ten seventeen.

Speaker 2

Before I ask Nager to review the financial results, I will provide a brief update on the psilocybin program for metabolic disease. The Phase 1 safety study from our investigational candidate, RALP11, is screening subject, and we expect the 1st randomization base soon. 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 RASB11 and select the optimal dose or doses for evaluation in a Phase 2a proof of concept study. We do expect to begin the Phase 2a study in 2025. Now we turn the call to our CFO, Maggot Sundar.

Speaker 2

Maggot?

Speaker 3

Sure. Thank you, Sergio. As noted by Tim, this afternoon we issued a press release announcing our business and financial results for the Q3 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 in the 1Q filing we completed today.

Speaker 3

These documents are available on our website in the News and SEC Filings tabs on the Investor Relations page. As of September 30, 2024, Raumata had cash, cash equivalents and short term investments of approximately $54,100,000 compared to $96,300,000 as of December 31, 2023. Cash used in operations in the Q3 ended September 30, 2024 was $16,700,000 compared to $11,600,000 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.

Speaker 3

Total research and development expense was approximately $11,100,000 as compared to $10,500,000 for the comparable period of 2023, an increase of approximately $600,000 The increase was primarily associated with a ramp up of expenses related to the 302 and 304 studies in 2024. Non cash charge related to stock based compensation for R and D totaled $1,700,000 in the Q3 of 2024. Total general and administrative expense for the Q3 was approximately $11,900,000 as compared to $12,200,000 for the comparable period of 2023, a decrease of approximately $300,000 The decrease was primarily driven by a decrease in stock based compensation expense. The non cash charge related to stock based compensation expense for G and A totaled $6,200,000 in the Q3 of 2024. The net loss for the Q3 of 2024 $21,700,000 or $0.72 per basic and diluted share, compared with a net loss of $22,000,000 or $0.73 per basic and diluted share in the comparable period of 2023.

Speaker 3

Note that the company had 30,200,000 common shares outstanding as of November 4, 2024. Before we open the call for questions, I'll turn back to Sergio for some closing comments. Sergio?

Speaker 2

Thank you, Magath. I would like to leave you with these key messages from today's call. Ramada number one objective is to complete the Phase 3 program and the NDA package for rel=ten seventeen. We expect to report the results outcomes of the preplanned interim analysis for the RELIANCE 2 Phase 3 study by year end 2024, and we do believe that this could be an important derisking event for the study and the REL1017 program. We plan to enroll the 1st subject in the Phase 1 single adjunctive study dosing study for P11 in development for metabolic disease very soon.

Speaker 2

With that said, we can open to questions. Operator?

Operator

Thank you. Our first question comes from the line of Andrew Tsai from Jefferies. Please go ahead.

Speaker 4

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 be just a few sentences? Or could it be something more detailed than that?

Speaker 2

Yes. Hi, Andrew. Thanks for the question. It's Sergio here. Well, yes, it's difficult to do it to decide in advance.

Speaker 2

We will 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 outcomes.

Speaker 4

Got it.

Speaker 2

So you will know what the DMC will tell us.

Speaker 4

Okay. And I heard 2.2 points somewhere earlier in your prepared remarks, but is that for statistical significance? Just to be clarify.

Speaker 2

Yes. Thanks, Andrew. No, it was 2.0. I read 2 twice. So it's about around 2 points delta.

Speaker 2

And I we say approximately because it depends, of course, from the standard deviation. So it can be slightly higher, slightly lower than 2.

Speaker 4

Got it. And then what threshold are you setting for the futility? What kind of placebo adjusted delta below placebo adjusted delta will you hit fertility?

Speaker 2

Yes. It's the same number, Andrew, it's about 2 points. So 2 points is kind of the threshold between clinical and non clinical significance. So we would like if we have a product, we would like to be sure that is also clinically meaningful. So it's about 2 points.

Speaker 2

So below 2 points, plusminus, a little bit due to the standard deviation. If it is below 2 points, it's probably going to be futile.

Speaker 4

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

Speaker 2

Thank you, Andy. I'll proceed.

Operator

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

Speaker 5

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 underlying data of matters changes for instance or is it mainly going to be the information related to the facility or not? Thank you.

Speaker 2

Yes. Thanks for the question. No, the we will only know what the data management committee will share with us. That is pretty much like the 3 outcomes. They won't provide any additional color or details.

Speaker 2

The EDMC and we want to maintain 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.

Speaker 5

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

Operator

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

Speaker 3

Hi, thanks for taking my question. It's Charles on for Uyghur. So I was curious, if the DMC recommends no change, would you continue to enroll to 300 or would that be that 400 or 340 number mentions? Yes. Thank you.

Speaker 3

Yes. Hi,

Speaker 2

Charles. Well, that would be the best outcome. But it's difficult to give a straight answer. Technically, usually, you tend to enroll a little bit more than the like the plan number, like maybe a few percent more just to be sure to account for the dropouts. And but the plan number is north of 300, between 3 and 340.

Speaker 2

So it's going to be around that number.

Speaker 3

Okay. Thanks for taking my question.

Operator

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

Speaker 6

Hi, team. This is Talani on for Andrea. Thanks for taking our questions. 2 from us. First, from a statistical perspective, can you confirm you're not taking a hit to alpha by conducting the interim analysis?

Speaker 6

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.

Speaker 2

Yes, 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 interim analysis. So there is no plan to stop the trial early.

Speaker 2

The best case scenario is to continue as planned. And that's one. And the second one was the dropout rate. It is low, right? It is in the single digit, mid single digit.

Speaker 2

And it is lower than in the previous trial. But I would be cautious everyone to read anything into that. It just means that there is like compliance and the adherence of the patient in the trial is good. So I would not translate anything from that in term of efficacy or something like that. It's about like mid single digit.

Speaker 6

That's helpful. Thank you.

Speaker 2

Thank you.

Operator

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

Speaker 2

Thank you. And in closing, as we get ready to read out on a very important upcoming clinical milestones for RELATEL17 as a potential adjunct treatment for MDD, 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.

Operator

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

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Earnings Conference Call
Relmada Therapeutics Q3 2024
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