Relmada Therapeutics, Inc. (NASDAQ:RLMD) Q1 2024 Earnings Call Transcript

Relmada Therapeutics, Inc. (NASDAQ:RLMD) Q1 2024 Earnings Call Transcript May 10, 2024

Relmada Therapeutics, Inc. isn't one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).

LifeSci Advisors: Sergio Traversa - Chief Executive Officer Maged Shenouda - Chief Financial Officer Andrew Cutler - Senior Clinical Development Advisor

Operator: Good afternoon, ladies and gentlemen, and welcome to the Relmada Therapeutics Inc. First Quarter 2024 Financial Results Conference Call. At this time, all lines are in a listen-only mode. Following the presentation, we will conduct a question-and-answer session. [Operator Instructions] This call is being recorded on Wednesday, May 8, 2024.

LifeSci Advisors:

Tim McCarthy: Thank you, Colin and thank you all for joining us this afternoon. With me on today's call are Chief Executive Officer, Sergio Traversa and Chief Financial Officer, Maged Shenouda. This afternoon, Relmada issued a press release, providing a business update, announcing financial results for the three months ended March 31, 2024. Please note that certain information discussed on the call today, is covered under the Safe Harbor provisions 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. This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast, May 8, 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. Now, I would like to turn the call over to Sergio. Sergio?

Sergio Traversa: Thank you, Tim, as always and good afternoon to everyone, and welcome to the Relmada first quarter 2024 conference call. We continue to achieve meaningful progress in the advancement of our ongoing Phase 3 program for REL-1017 in major depressive disorder, MDD as well as in the promising preclinical novel psilocybin program, all of which I will briefly cover today. Following this, Maged will review our first quarter 2024 financial results, and then we will take your questions. Let's begin with an update on the late-stage Phase 3 program for REL-1017. As a reminder, Relmada is focused on developing REL-1017 as an adjunctive treatment for MDD. We previously executed important revision to Reliance II, the ongoing study 302, which is a Phase 3, two-arm, placebo-controlled pivotal study evaluating REL-1017 25 mg for adjunctive MDD.

These modifications were aimed at controlling placebo response and improving the profile of patients enrolled. The amended study 302 protocol has been implemented across all of our clinical sites. Enrollment continues to advance and our ability to leverage our close relationship with the study sites continue to play a critical role. Moreover, the ongoing initiative we put in place to drive trial awareness with prospective patients are also generating positive results. As we said on our last call, we are evaluating the quality and productivity of sites on a real-time basis and making tweaks as appropriate. As a reminder, we plan to enroll approximately 300 patients into Reliance II. Based on our current projection, we continue to expect Reliance II to be completed with top-line data anticipated in the second half of this year.

We are also continuing to enroll and dose patients in our second Phase 3 trial for REL-1017 Relight or study 304, that also has a planned enrollment of approximately 300 patients. Like Reliance II Relight is a randomized, double-blind, placebo-controlled four weeks trial evaluating the efficacy and safety of REL-1017 as an adjunctive treatment of MDD in patients experiencing inadequate response to ongoing background antidepressant treatment. The primary endpoint of both studies is the same, the change in the MADRS total score from baseline to day 28 for REL-1017 as compared to placebo. I would like to emphasize again that we have made meaningful revision to our screening and enrollment processes in order to ensure that we have patients that meet all of the qualifying criteria within our desired patient profile.

To this end, we are now executing on a comprehensive adjudication process through which we require medical and pharmacy records for all patients enrolled in Reliance II and Relight. Given this the screen failure rate in this study has increased to approximately 80% versus approximately 50% in Reliance I and Reliance III, our previously completed Phase 3 trial REL-1017. However, we are highly confident that these changes will substantially enhance the probability of success of the current studies. I would also like to highlight that we have completed all of the necessary preclinical manufacturing and Phase 1 studies required for a potential REL-1017 NDA filing and our current focus is on executing the remaining two Phase 3 studies, 302 and 304.

Moving on now to the promising novel modified release psilocybin program, we continue to anticipate the initiation of a single ascending dose Phase 1 trial in obese patients in the first half of this year to define the pharmacokinetic safety and tolerability profile of our modified release psilocybin formulation in this population, followed by the Phase 2A trial to establish clinical proof-of-concept. Data from the plan and to a study is anticipated in the first half of 2025. These blended studies will build on the compelling preclinical data that were presented in a poster presentation at last November's AASLD meeting, the Liver Conference. These results showed the beneficial effect of low chronic dose psilocybin on multiple metabolic parameters in a rodent model of metabolic dysfunction associated steatotic liver disease or MASLD.

Based on these data low dose psilocybin could improve lipids and glucose with potential for fewer side effects over other investigative treatment approaches such as GLP-1, glucagon, and GIP. So to summarize our multiple upcoming key milestones over the next 12, 18 months, we anticipate the ongoing Reliance II study to be completed with top-line data in the second half of this year. In addition, we anticipate initiating a Phase i clinical trial for our modified release formulation of psilocybin before the end of the current quarter. Lastly, while Maged will provide a detailed review of our financials, I would like to highlight, that we continue to advance our pipeline for a position of significant financial strength with cash on hand to take us comfortably into 2025.

I will now turn the call over to Maged to review our first quarter financial results. Maged?

Maged Shenouda: Thank you, Sergio. Today we issued a press release announcing our business and financial results for the three months ended March 31, 2024, which I will now review. For the first quarter ended March 31, 2024, total research and development expense was approximately $13.3 million, as compared to $15.9 million for the comparable period of 2023, a decrease of approximately $2.6 million. The decrease was primarily associated with the completion of the long-term open-label study, Study 310 in the third quarter of 2023, as well as Reliance I and III. The non-cash charge related to stock-based compensation for R&D totaled $1.7 million in the most recently completed first quarter. Total general and administrative expense for the first quarter ended March 31, 2024, was approximately $9.7 million as compared to $12.3 million for the comparable period of 2022, a decrease of approximately $2.6 million.

The decrease was primarily driven by a decrease in stock-based compensation expense. A non-cash charge related to stock-based compensation for G&A totaled $6.6 million in the most recently completed first quarter. For the first quarter ended March 31, 2024, the net loss was $21.8 million or $0.72 per basic and diluted share compared with a net loss of $26.3 million or $0.87 per basic and diluted share in the comparable period of 2023. As of March 31, 2024, we had cash, cash equivalents and short-term investments of approximately $83.6 million compared to $96.3 million as of December 31, 2023. Cash used in operations in the first quarter of 2023 was $13 million. Based on our clinical development plan, our current cash position provides us with comfortable runway into 2025.

I will now ask the operator to please open up the call for questions. Operator?

See also

25 Best All-Inclusive Resorts in Cancun and

15 Best Places in Maryland For A Couple To Live On Only Social Security.

To continue reading the Q&A session, please click here.