CORAL GABLES, Fla., August 11, 2022 /PRNewswire/ — Relmada Therapeutics, Inc. (Nasdaq: RLMD) (“Relmada,” the “Company,” “we,” “us,” “our”), an early-stage biotechnology company treating diseases of the central nervous system (CNS), today provided a corporate update and has announced preliminary, unaudited updated 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 ET/1:30 PM Pacific Time.
Latest corporate aspects
The FDA granted Fast Track designation to REL-1017 as monotherapy for the treatment of major depressive disorder (MDD) John Hixona veteran of biopharmaceutical marketing and commercial planning, to serve as the newly created position of head of commercial published REL-1017 preclinical data on lack of reinforcing behavior, physical dependence, and withdrawal signs in the peer-reviewed journal , Scientific reports and preclinical data suggesting that noncompetitive NMDAR blockers with a preference for the GluN1-2D subtype may have particular therapeutic relevance in the peer-reviewed journal, Pharmaceuticals.
“We are rapidly approaching several key catalysts in Reliance’s ongoing Phase 3 clinical development program for REL-1017 as a novel, paradigm-shifting treatment for people living with MDD,” he said. Sergio Traversa, CEO of Relmada. “We expect to complete enrollment of Reliance III, the monotherapy trial, shortly, followed shortly by a top-line readout from the study. We also continue to await top-line results from Reliance I and Reliance II, the two sisters ongoing two-arm, placebo-controlled, pivotal studies evaluating REL-1017 as a possible adjunctive treatment in this second half of the year.
“In addition to receiving Fast Track designation for REL-1017 as a monotherapy for the treatment of MDD, we made significant progress with our commercial readiness activities for REL-1017,” he continued. Sergio Traversa. “For this purpose, we have recently appointed ourselves John Hixonwho has over 36 years of sales and marketing experience within the biopharmaceutical industry, including direct marketing experience in the CNS and depression space as Chief Commercial Officer.”
Next planned milestones for REL-1017
Results from the RELIANCE III monotherapy MDD trials in the second half of 2022 with the last patient enrolled before the end of August 2022. open study) in MDD in the first half of 2023
Financial results for the second quarter of 2022
Research and development expenses for the three months ended June 30, 2022added up 24.6 million dollarscompared to 17.3 million dollars during the past three months June 30, 2021. The increase was primarily driven by increased costs associated with the preparation and execution of Reliance, the company’s Phase 3 program for REL-1017. General and administrative expenses for the three months ended June 30, 2022added up 14.6 million dollars compared to 9.1 million dollars during the past three months June 30, 2021an increase of approx 5.5 million dollars. The increase was primarily driven by an increase in stock-based compensation. The net loss of the three months ended June 30, 2022was 39.9 million dollarsor $1.33 per diluted share, compared to a net loss of 26.6 million dollarsor $1.56 per diluted share, during the three months ended June 30, 2021.
Six months over June 30, 2022 Financial results
Research and development expenses for the six months ended June 30, 2022added up 49.6 million dollarscompared to 31.4 million dollars during the last six months June 30, 2021. The increase was primarily driven by increased costs associated with the preparation and execution of Reliance, the company’s Phase 3 program for REL-1017. General and administrative expenses for the last six months June 30, 2022added up 27.9 million dollarscompared to 17.5 million dollars during the last six months 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 in 2021 it was 79.7 million dollars i 48.8 million dollars, respectively. The company had a net loss of $2.73 i $2.90 per share during the six months ended June 30, 2022 and 2021, respectively. How of June 30, 2022the company had cash, cash equivalents and short-term investments of approx $212.0 millioncompared to cash, cash equivalents and short-term investments of approx. 211.9 million dollars at December 31, 2021.
Conference call and webcast details
REL-1017, a novel chemical entity (NCE) and novel NMDA receptor (NMDAR) channel blocker that preferentially targets overactive channels while maintaining physiological glutamatergic neurotransmission, is currently in development for the treatment of the disorder major depressive disorder (MDD). Reliance’s ongoing clinical research program is designed to evaluate the potential of REL-1017 as a rapid-acting, once-daily oral 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 the results observed in previously conducted Phase 1 studies.
About Relmada Therapeutics, Inc.
Relmada Therapeutics is a late-stage biotechnology company addressing diseases of the central nervous system (CNS), with a 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 a novel NMDA receptor (NMDAR) channel blocker that preferentially targets overactive channels while maintaining physiological glutamatergic neurotransmission. REL-1017 has entered an advanced phase of development as a novel treatment for MDD in adults. In addition, Relmada is advancing a clinical phase program in neurodegenerative diseases based on psilocybin and selected derivative molecules. More information at www.relmada.com.
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by us or on our behalf. This press release contains statements that constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including, without limitation, statements about the Relmada’s plans to develop REL-1017. , and expectations related to trials evaluating REL-1017 and potential regulatory approval of REL-1017. Any statement that is not historical in nature is a forward-looking statement and can be identified by the use of words and phrases such as “expects”, “anticipates”, “believes”, “will”, “will likely result”, “will continue” , “plans”, “potential”, “promising” and similar expressions. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including the risk factors described in heading “Risk”. Factors” set forth in the Company’s reports filed with the SEC from time to time. No forward-looking statements can be guaranteed and actual results may differ materially from those anticipated. Relmada undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.Readers are cautioned that it is not possible to predict or identify all risks, uncertainties and other factors that may affect future results and that the risks described herein should not to be a complete list.
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SOURCE Relmada Therapeutics, Inc.