Relmada Therapeutics(US:RLMD)2022-11-10 21:06Drug Development and Clinical Trials - 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[115]. - 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 and effect sizes ranging from 0.7 to 1.0[118][119]. - The Phase 3 program for REL-1017 includes two placebo-controlled trials across 55 clinical sites in the U.S., with the primary endpoint being the change in MADRS score at Day 28[123]. - The FDA granted Fast Track designation to REL-1017 as a monotherapy for MDD, indicating potential expedited review[124]. - The RELIANCE III study did not achieve its primary endpoint, showing a MADRS reduction of 14.8 points for REL-1017 compared to 13.9 points for placebo at Day 28[125]. - Esmethadone is currently in Phase 3 trials for the adjunctive treatment of major depressive disorder (MDD), with robust efficacy demonstrated in a randomized Phase 2 trial[148]. - In a Human Abuse Potential study, all doses of REL-1017 showed a statistically significant difference in abuse potential compared to oxycodone, supporting the lack of opioid effects[128]. - Esmethadone's mechanism of action as a non-competitive NMDA antagonist differentiates it from currently approved antidepressants, potentially offering rapid effects without adverse side effects[133]. - The urgent need for faster-acting antidepressant treatments is highlighted by the fact that severe depression can be life-threatening, with a significant portion of patients not achieving adequate therapeutic benefits[132]. Financial Performance - For the nine months ended September 30, 2022, the net loss was approximately $119,099,500, compared to a net loss of $91,373,300 for the same period in 2021, representing an increase of approximately 30.3%[161]. - Research and development expenses for the nine months ended September 30, 2022, were approximately $86,454,600, an increase of approximately $21,106,900 from $65,347,700 for the same period in 2021, reflecting a 32.3% increase[157]. - The total operating expenses for the nine months ended September 30, 2022, were approximately $122,546,656, compared to $91,520,718 for the same period in 2021, marking an increase of approximately 35.9%[156]. - The company incurred negative operating cash flows of $67,918,717 for the nine months ended September 30, 2022[162]. - The company has not generated revenues and does not anticipate generating revenues for the foreseeable future[142]. - For the nine months ended September 30, 2022, cash used in operating activities was $67,918,717, an increase of 24.9% compared to $54,213,231 for the same period in 2021[166]. - The net loss for the nine months ended September 30, 2022, was $119,099,458, compared to a net loss of $91,373,316 for the same period in 2021, reflecting a year-over-year increase of 30.3%[167]. - Cash provided by investing activities for the nine months ended September 30, 2022, was $21,389,056, a decrease of 42.3% from $37,064,696 in 2021[168]. - Net cash provided by financing activities for the nine months ended September 30, 2022, was $44,610,591, an increase of 70.9% compared to $26,102,432 in 2021[169]. - Sales of common stock contributed $42,728,599 to financing activities for the nine months ended September 30, 2022, compared to $23,416,036 in 2021, indicating an increase of 82.5%[170]. - The company experienced a net decrease in cash and cash equivalents of $1,919,070 for the nine months ended September 30, 2022, contrasting with an increase of $8,953,897 in the same period of 2021[166]. Market and Patent Information - The market for CNS diseases is estimated to affect nearly 2 billion people globally, representing approximately 40% of the total disease burden, indicating a significant revenue opportunity[145]. - The company has over 50 issued patents and pending patent applications related to REL-1017, potentially providing coverage beyond 2033[147]. Risk Factors and Financial Reporting - Inflation affects the company's expenses, particularly in employee compensation and contract services, which could increase the level of expenses[171]. - There have been no material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2021[172]. - The company’s financial statements are prepared in accordance with U.S. GAAP, requiring management to make estimates and assumptions that affect reported amounts[174]. - There have been no material changes to the company's exposures to market risks as disclosed in the annual MD&A contained in the Form 10-K for the year ended December 31, 2021[175].