Relmada Therapeutics Q3 2024 Earnings Report

Relmada Therapeutics EPS Results

• Actual EPS: -$0.72
• Consensus EPS: -$0.65
• Beat/Miss: Missed by -$0.07
• One Year Ago EPS: -$0.73

Relmada Therapeutics Revenue Results

• Actual Revenue: N/A
• Expected Revenue: N/A
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

Relmada Therapeutics Announcement Details

• Quarter: Q3 2024
• Date: 11/7/2024
• Time: After Market Closes
• Conference Call Date: Thursday, November 7, 2024
• Conference Call Time: 4:30PM ET

Relmada Therapeutics (NASDAQ:RLMD) is a clinical-stage biopharmaceutical company focused on the development of novel therapies for pain and other central nervous system (CNS) disorders. The company applies a proprietary stereochemical approach to optimized drug candidates, aiming to improve safety, tolerability and efficacy profiles compared with existing treatments. Relmada’s research efforts center on modulation of NMDA receptors to address unmet needs in depression, neuropathic pain and related indications.

Relmada’s lead product candidate, REL-1017 (d-methadone), is being evaluated as a potential rapid-acting and maintenance treatment for major depressive disorder, with clinical studies underway to assess its utility in both acute and long-term settings. In parallel, the company is advancing additional pipeline programs targeting neuropathic pain, including diabetic neuropathy and chemotherapy-induced peripheral neuropathy. Relmada collaborates with academic centers and contract research organizations to conduct multi-center trials across North America and Europe.

Headquartered in New York, Relmada Therapeutics was incorporated in Delaware and maintains its research operations in the United States. The company is led by a management team with extensive experience in biopharmaceutical development, regulatory strategy and commercial planning. Relmada’s common stock is listed on the NASDAQ under the symbol RLMD.

Relmada Therapeutics Q3 2024 Earnings Call Transcript

Key Takeaways

• REL1017 Phase III interim analysis is expected by year-end 2024, representing a potential major de-risking event for the program.
• The RELIANCE 2 study has three possible outcomes—continue as planned, add patients to boost power, or stop for futility (below ~2-point drug-placebo delta)—with no alpha penalty on interim testing.
• The psilocybin-based metabolic disease candidate RALP11 is now in Phase 1 safety screening in Canada, with Phase 2a proof-of-concept dosing slated to begin in 2025.
• Cash reserves declined to $54.1 M at September 30, 2024 (from $96.3 M at year-end 2023), with a Q3 operating cash burn of $16.7 M, funding operations into 2025.

Presentation

[Operator]

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 company's website. I would now like to turn the call over to Tim McCarthy from LifeSci Advisors. Please go ahead, Mr. McCarthy.

[Tim McCarthy, Managing Director of Relationship Management at LifeSci Advisors]

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 harbor 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. 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 for the year ended December 31, 2023, and subsequent filings, including the third quarter 2024 10-Q filed after the close today.

[Tim McCarthy, Managing Director of Relationship Management at LifeSci Advisors]

This conference call also contains time-sensitive information and is accurate only as of the date of this live broadcast, November 7th, 2024. 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 CEO, Dr. Sergio Traversa, who will briefly provide a summary of recent business highlights, and Relmada CFO, Maged Shenouda, 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?

[Sergio Traversa, CEO at Relmada Therapeutics]

Thank you, Tim, and good afternoon, and welcome everyone to the Relmada Third Quarter 2024 Conference Call. Relmada's number one priority is to advance the development of new treatments for CNS disorder, including major depressive disorder, MDD. Our number one objective is to successfully complete the phase III program and the NDA package for Relmada 1017, or esmethadone, with a laser focus on de-risking 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 Relmada 1017 program and the company. As a reminder, with Relmada 1017, we aim to provide patients with MDD a new adjunctive treatment option to be used in combination with their current regimen.

[Sergio Traversa, CEO at Relmada Therapeutics]

Approximately 10 million people were treated for a major depressive episode in the last year, and 40% of these patients, that is about 4 million people, required combination therapy. This is U.S. only. Our phase III registration program has been designed to build on key learnings from our previously conducted phase III and phase II programs. In today's call, I will focus on Relmada 1017 and also provide a brief update on our psilocybin-based metabolic disease program. After that, Maged will review our financial results, and then we will take your questions. The clinical program for Relmada 1017 is comprised of two studies: Reliance II and Relight. As a reminder, each study was designed as a double-blinded, placebo-controlled, randomized phase III registration or clinical trial to evaluate Relmada 1017 in patients with clinical depression.

[Sergio Traversa, CEO at Relmada Therapeutics]

We are on track to provide the outcome of the planned sample size re-estimation interim analysis for the Reliance II study by year-end 2024. There are three potential outcomes based on the DMC Data Monitoring Committee recommendations from the unblinded interim analysis. The first potential outcome is that the study can continue with the pre-planned 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 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. We would view this as an encouraging signal from the study and worth the time and cost to extend enrollment.

[Sergio Traversa, CEO at Relmada Therapeutics]

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 two 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 de-risky event for Relmada 1017. Before I ask Maged to review the financial results, I will provide a brief update on the psilocybin program for metabolic disease. The phase I safety study from our investigational candidate, Relmada P11, is screening subjects, and we expect the first randomization very soon.

[Sergio Traversa, CEO at Relmada Therapeutics]

The study will be conducted in Canada with obese individuals and will allow us to define the pharmacokinetic safety and tolerability profile for a single dose of Relmada P11 and select the optimal dose or doses for evaluation in a phase IIA proof-of-concept study. We do expect to begin the phase II-A study in 2025. Now we'll turn the call to our CFO, Maged Shenouda. Maged?

[Maged Shenouda, CFO at Relmada Therapeutics]

Sure.

[Maged Shenouda, CFO at Relmada Therapeutics]

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 10-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, Relmada 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.

[Maged Shenouda, CFO at Relmada Therapeutics]

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 a 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 totaled $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. The non-cash charge related to stock-based compensation expense for G&A totaled $6.2 million in the third quarter of 2024.

[Maged Shenouda, CFO at Relmada Therapeutics]

The net loss for the third quarter of 2024 was $21.7 million, or $0.72 per basic and diluted share, compared with a net loss of $22 million, or $0.73 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 4, 2024. Before we open the call for questions, I'll turn back to Sergio for some closing comments. Sergio?

[Sergio Traversa, CEO at Relmada Therapeutics]

Thank you, Maged. I would like to leave you with these key messages from today's call. Relmada's number one objective is to complete the phase III program and the NDA package for Relmada 1017. We expect to report the results of the pre-planned interim analysis for the Reliance II phase III study by year-end 2024, and we do believe that this could be an important de-risking event for the study and the REL-1017 program. We plan to enroll the first subject in the phase I single-agent dosing study for P11 in development for metabolic disease very soon. With that said, we can open the question, Operator.

[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 Jefferies. Please go ahead.

[Andrew Tsai, Senior VP at Jefferies]

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?

[Sergio Traversa, CEO at Relmada Therapeutics]

Yeah, hi, Andrew. Thanks for the question. It's Sergio here. Well, yeah, it's difficult to decide in advance. Really, 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 outcomes.

[Andrew Tsai, Senior VP at Jefferies]

Got it.

[Sergio Traversa, CEO at Relmada Therapeutics]

So you will know what the DMC will tell us.

[Andrew Tsai, Senior VP at Jefferies]

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

[Sergio Traversa, CEO at Relmada Therapeutics]

Yes. Thanks, Andrew. No, it was 2.0. I read two twice. So it's around 2 points delta. And we say approximately because it depends, of course, from the standard deviation. So it can be slightly higher, slightly lower than two.

[Andrew Tsai, Senior VP at Jefferies]

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

[Sergio Traversa, CEO at Relmada Therapeutics]

Yeah, it's the same number, Andrew. It's about two points. So two 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 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 futile.

[Andrew Tsai, Senior VP at Jefferies]

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

[Sergio Traversa, CEO at Relmada Therapeutics]

Thank you, Andrew. I appreciate it.

[Operator]

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

[Basma Radwan, VP at Leerink Partners]

Hi, good afternoon. This is Basma on for Marc. 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 unblinding data of MADRS changes, for instance? Or is it mainly going to be the information related to the futility or not? Thank you.

[Sergio Traversa, CEO at Relmada Therapeutics]

Yeah, thanks for the question. No, we will only know what the Data Monitoring Committee will share with us. That is pretty much like the three outcomes. They won't provide any additional color or details. The DMC and we want to maintain the integrity of the data. So we will only know if it is futile, if we can continue as planned, or if we need to add patients to increase the power. That's it.

[Basma Radwan, VP at Leerink Partners]

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

[Operator]

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

[Charles Ence, Chief Accounting and Compliance Officer at Relmada Therapeutics]

Hi. Thanks for taking my question. It's Charles Ence for Uy Ear. So I was curious, if the DMC recommends no change, would you continue to enroll to 300, or would that be that 440 number mentioned? Yeah. Thank you.

[Sergio Traversa, CEO at Relmada Therapeutics]

Yeah. Hi, 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 plan number, like maybe a few % more, just to be sure to account for the dropouts. But the plan number is north of 300, between 300 and 340. So it's going to be around that number.

[Charles Ence, Chief Accounting and Compliance Officer at Relmada Therapeutics]

Okay. Thanks for taking my question.

[Operator]

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

[Tolani Uthman, Associate of Global Investment Research at Goldman Sachs]

Hi, team. This is Tolani 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 % screen failure rates in Reliance II compared to those from the prior studies? Thanks.

[Sergio Traversa, CEO at Relmada Therapeutics]

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 interim analysis. So there is no plan to stop the trial early. 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, and it is lower than in the previous trial. But I would be cautious of everyone to read anything into that. It just means that there is compliance and the adherence of the patient in the trial is good. So I would not translate anything from that in terms of efficacy or something like that. It's about mid-single digit.

[Tolani Uthman, Associate of Global Investment Research at Goldman Sachs]

That's helpful. Thank you.

[Sergio Traversa, CEO at Relmada Therapeutics]

Thank you.

[Operator]

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

[Sergio Traversa, CEO at Relmada Therapeutics]

Thank you, and in closing, as we get ready to read out on a very important upcoming clinical milestone for Relmada 1017 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.

Participants

Executives

• Maged Shenouda, CFO
• Charles Ence, Chief Accounting and Compliance Officer
• Sergio Traversa, CEO

Analysts

• Andrew Tsai, Senior VP at Jefferies
• Tim McCarthy, Managing Director of Relationship Management at LifeSci Advisors
• Basma Radwan, VP at Leerink Partners
• Tolani Uthman, Associate of Global Investment Research at Goldman Sachs