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Relmada Therapeutics Provides Corporate Update and Reports Third Quarter 2021 Financial Results
CORAL GABLES, Fla., Nov. 11, 2021 /PRNewswire/ -- Relmada Therapeutics, Inc. (Nasdaq: RLMD), a late-stage biotechnology company addressing diseases of the
About this update from Relmada Therapeutics, Inc.
[{"type":"text","content":"CORAL GABLES, Fla., Nov. 11, 2021 /PRNewswire/ -- 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 financial results for the three and nine months ended September 30, 2021.\n\n \n \n \n \n \n \n\n \n\"Our REL-1017 development program for the treatment of major depressive disorder remains on track, and we expect key data catalysts in each quarter of next year,\" said Dr. Sergio Traversa, Relmada's Chief Executive Officer. \"We anticipate top-line results from our second human abuse potential study, this one assessing REL-1017 versus intravenous ketamine, in the first quarter, followed by top-line data from RELIANCE III, our ongoing monotherapy registrational Phase 3 study in the second quarter. We expect top-line results from RELIANCE I and RELIANCE II, our Phase 3 pivotal studies for adjunctive treatment, in the third and fourth quarters of 2022, respectively. Importantly, our robust R&D initiatives are supported by a strong balance sheet.\" \nRecent Corporate Highlights\nRELIANCE III, the ongoing monotherapy study for major depressive disorder, being conducted as a registrational Phase 3 trial. The US Food and Drug Administration (FDA) confirmed that Relmada will not be required to conduct a two-year carcinogenicity study or a TQT cardiac study in humans to support regulatory approval submissions for REL-1017, as the data provided to date and the additional data to be generated by the Phase 3 program will be adequate to evaluate the cardiac safety profile of REL-1017. Presented eight posters on REL-1017 at the Neuroscience Education Institute (NEI) Congress, including three posters with new data from post-hoc analyses related to the REL-1017 Phase 2 program.Third Quarter 2021 Financial Results\nResearch and development expenses for the three months ended September 30, 2021, totaled $34.0 million, compared to $11.2 million in the third quarter ended September 30, 2020. 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 expenses for the third quarter ended September 30, 2021, totaled $8.7 million, up from $5.9 million in the third quarter ended September 30, 2020, an increase ...