Relmada Therapeutics(US:RLMD)2022-05-05 20:05Drug Development - Relmada Therapeutics is developing esmethadone (REL-1017) as a rapidly acting oral agent for the treatment of major depressive disorder (MDD) and other CNS diseases[106]. - In the Phase 2 clinical trial (REL-1017-202), subjects receiving 25 mg and 50 mg doses of REL-1017 showed statistically significant improvements in MADRS scores compared to placebo, with P values < 0.03[109][110]. - The Phase 3 program for REL-1017 includes two placebo-controlled trials with a planned enrollment of 364 MDD patients, focusing on the change from baseline on the MADRS score at day 28 as the primary endpoint[114]. - The FDA confirmed that Relmada is not required to conduct a two-year carcinogenicity study for REL-1017, as sufficient clinical data have been generated[117]. - In a Human Abuse Potential study, REL-1017 demonstrated a highly statistically significant difference in likability compared to oxycodone, with P values < 0.001 across all tested doses[118][119]. - Esmethadone's mechanism of action as a low affinity, non-competitive NMDA channel blocker differentiates it from currently FDA-approved antidepressants, potentially reducing adverse side effects[126]. - The Phase 2a study confirmed the tolerability profile of REL-1017, with only mild and moderate adverse events reported, and no serious adverse events observed[113]. - The average age of subjects in the REL-1017-202 study was 49.2 years, with an average Hamilton Depression Rating Scale score of 25.3, indicating severe depression[108]. - The company plans to continue developing esmethadone as a priority program, with ongoing Phase 3 trials for the treatment of major depressive disorder (MDD)[141]. Financial Performance - For the three months ended March 31, 2022, the company reported a net loss of approximately $39,745,800, compared to a net loss of $22,215,200 for the same period in 2021, representing an increase in loss of approximately 79.3%[146]. - Research and development expenses for the three months ended March 31, 2022, were approximately $25,012,900, an increase of approximately 78.3% from $14,022,200 for the same period in 2021[142]. - General and administrative expenses for the three months ended March 31, 2022, were approximately $13,284,600, up approximately 58.5% from $8,383,000 for the same period in 2021[142]. - The company incurred negative operating cash flows of $19,429,743 for the three months ended March 31, 2022, compared to negative cash flows of $16,085,475 for the same period in 2021[151]. - The company raised net proceeds of $29,583,542 from the sale of common stock through its ATM equity offering during the three months ended March 31, 2022[148]. - The company has an accumulated deficit of $344,812,895 as of March 31, 2022[147]. - The company does not anticipate generating revenues for the foreseeable future as none of its product candidates have been approved for sale[132]. Market Context - Approximately 15.7 million adults in the U.S. experienced at least one major depressive episode in the past year, highlighting the urgent need for effective treatments[124][125]. - The market for CNS diseases is estimated to affect nearly 2 billion people globally, representing approximately 40% of the total disease burden[136]. - The company has over 50 issued patents and pending patent applications related to its product REL-1017, which may provide market exclusivity for up to 10 years in the European Union[138]. Accounting and Risk Management - The unaudited condensed consolidated financial statements are prepared in accordance with U.S. GAAP, considering all applicable accounting standards effective as of March 31, 2022[158]. - Management's estimates and assumptions are based on historical experience and reasonable assumptions, which may affect reported amounts of assets and liabilities[158]. - There have been no material changes to the company's exposures to market risks as disclosed in the annual MD&A for the year ended December 31, 2021[159].