Relmada Therapeutics, Inc. (Nasdaq: RLMD), a late-stage biotechnology company addressing diseases of the central nervous system (CNS), today provided a corporate update and announced preliminary and unaudited financial results for the three and six months ended June 30, 2022. The Company will host a conference call today, Thursday, August 11, at 4:30 PM Eastern Time/1:30 PM Pacific Time.

Recent Corporate Highlights

  • FDA granted Fast Track designation to REL-1017 as a monotherapy for the treatment of major depressive disorder (MDD)
  • Appointed John Hixon, a biopharmaceutical marketing and commercial planning veteran, to serve as the newly created position of Head of Commercial
  • Published REL-1017 preclinical data on the lack of reinforcement behavior, physical dependence, and withdrawal signs in the peer-reviewed journal, Scientific Reports, and preclinical data suggesting that uncompetitive NMDAR blockers with a preference for the GluN1-2D subtype may be of particular therapeutic relevance in the peer-reviewed journal, Pharmaceuticals

“We are rapidly approaching multiple key catalysts from Reliance, the ongoing Phase 3 clinical development program for REL-1017 as a paradigm shifting novel treatment for individuals living with MDD,” “We anticipate completing the enrollment of Reliance III, the monotherapy trial, shortly, followed soon thereafter by a top-line readout of the study. We also continue to expect top-line results from Reliance I and Reliance II, the two ongoing sister, two-arm, placebo-controlled, pivotal studies evaluating REL-1017 as a potential adjunctive treatment, in this second half of the year.

Sergio Traversa, Relmada’s Chief Executive Officer

“In addition to receiving Fast Track designation for REL-1017 as a monotherapy for the treatment of MDD, we achieved important progress with our commercial preparation activities for REL-1017,” continued Sergio Traversa. “To this end, we recently appointed John Hixon, who has over 36 years of sales and marketing experience within the biopharmaceutical industry, including direct marketing expertise in the CNS and depression space, as Head of Commercial.”

Upcoming Anticipated Milestones for REL-1017

  • Results of RELIANCE III monotherapy MDD trials in the second half of 2022 with last patient enrolled before the end of August, 2022
  • Results of RELIANCE I and RELIANCE II adjunctive MDD trials in the second half of 2022
  • Results of RELIANCE – OLS (Long-term, Open-label) study in MDD in the first half of 2023

Second Quarter 2022 Financial Results

  • Research and development expense for the three months ended June 30, 2022, totaled $24.6 million, compared to $17.3 million for the three months ended June 30, 2021. The increase was primarily driven by increased costs associated with preparing and conducting Reliance, the Company’s Phase 3 program for REL-1017.
  • General and administrative expense for the three months ended June 30, 2022, totaled $14.6 million compared to $9.1 million for the three months ended June 30, 2021, an increase of approximately $5.5 million. The increase was primarily driven by an increase in stock-based compensation.
  • The net loss for the three months ended June 30, 2022, was $39.9 million, or $1.33 per diluted share, compared with a net loss of $26.6 million, or $1.56 per diluted share, for the three months ended June 30, 2021.

Six Months Ended June 30, 2022 Financial Results

  • Research and development expense for the six months ended June 30, 2022, totaled $49.6 million, compared to $31.4 million for the six months ended June 30, 2021. The increase was primarily driven by increased costs associated with preparing and conducting Reliance, the Company’s Phase 3 program for REL-1017.
  • General and administrative expense for the six months ended June 30, 2022, totaled $27.9 million, compared to $17.5 million for the six months ended June 30, 2021. The increase was primarily driven by an increase in stock-based compensation.
  • Net loss for the six months ended June 30, 2022 and 2021 was $79.7 million and $48.8 million, respectively. The Company had a net loss of $2.73 and $2.90 per share for the six months ended June 30, 2022 and 2021, respectively.
  • As of June 30, 2022, the Company had cash, cash equivalents, and short-term investments of approximately $212.0 million, compared to cash, cash equivalents, and short-term investments of approximately $211.9 million at December 31, 2021.

About REL-1017

REL-1017, a new chemical entity (NCE) and novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission, is currently in late-stage development for the treatment of major depressive disorder (MDD). The ongoing Reliance Clinical Research Program is designed to evaluate the potential for REL-1017 as a rapid-acting, oral, once-daily antidepressant treatment. In a Phase 2 trial, REL-1017 demonstrated rapid, robust, and sustained antidepressant effects with statistically significant improvements compared to placebo. The Phase 2 study also showed a favorable pharmacokinetic, safety, and tolerability profile of REL-1017 consistent with results observed in previously completed Phase 1 studies.

About Relmada Therapeutics, Inc.

Relmada Therapeutics is a late-stage biotechnology company addressing diseases of the central nervous system (CNS), with focus on major depressive disorder (MDD). Relmada’s experienced and dedicated team is committed to making a difference in the lives of patients and their families. Relmada’s lead program, REL-1017, is a new chemical entity (NCE) and novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission. REL-1017 has entered late-stage development as  a novel treatment for MDD in adults. In addition, Relmada is advancing a clinical-stage program in neurodegenerative diseases based on psilocybin and select derivative molecules. Learn more at www.relmada.com.