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BB Relmada THERAPEUTICS Relmada Therapeutics Provides Corporate Update and Reports Third Quarter 2021 Financial Results -- CORAL GABLES , Fla . , November 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 . " 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 . ” Recent Corporate Highlights • RELIANCE 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 • • Research 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 of approximately $ 2.8 million . The increase was primarily driven by increases in personnel costs , stock - based compensation , and consulting services .