Relmada Therapeutics(US:RLMD)2023-05-13 01:10Financial Data and Key Metrics Changes - For Q1 2023, total research and development expenses were approximately $15.9 million, down from $25 million in the same period of 2022, primarily due to the completion of Study 301 and Study 303 [29] - General and administrative expenses for Q1 2023 were approximately $12.3 million, compared to $13.3 million in Q1 2022, reflecting a decrease of about $1 million [30] - The net loss for Q1 2023 was $26.3 million or $0.87 per share, compared to a net loss of $39.7 million or $1.40 per share in Q1 2022 [32] - Cash, cash equivalents, and short-term investments as of March 31, 2023, totaled approximately $132.4 million, down from $148.3 million as of December 31, 2022 [34] Business Line Data and Key Metrics Changes - The ongoing Study 302 is expected to enroll approximately 300 patients, with over one-third already enrolled, and is anticipated to complete in the first half of 2024 [24] - The new Study 304 is planned to initiate in mid-2023, also with a target enrollment of approximately 300 patients, expected to complete in the second half of 2024 [24] Market Data and Key Metrics Changes - The company is focusing on optimizing the design of clinical trials to enhance signal detection and control placebo response, which has been a significant issue in previous studies [16][19] - The company has identified and is working with clinical sites that have demonstrated better control over placebo responses in past trials [50] Company Strategy and Development Direction - The company intends to primarily focus on REL-1017 as an adjunctive treatment for major depressive disorder (MDD) and has implemented changes to improve trial designs based on previous learnings [12][16] - The management emphasizes the importance of recruiting appropriately diagnosed subjects and controlling for placebo response in ongoing and upcoming studies [22][23] - The company is confident in its funding position to execute plans through the end of 2024, supported by the completion of certain studies [31] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about the approval of REL-1017 and believes that the right plans and team are in place to optimize chances for success [87] - The management acknowledges the challenges faced in previous studies but is focused on improving patient selection and trial design to ensure better outcomes [79] Other Important Information - The open-label one-year safety study for REL-1017 is concluding, with final safety follow-up visits occurring soon, and data is expected to be released later this year [25] - The company has had two late-breaking posters accepted for presentation at the upcoming 2023 American Society of Clinical Psychopharmacology meeting [26] Q&A Session Summary Question: Overlap between Study 302 and Study 304 sites - Management confirmed that there is no overlap between the sites for Study 302 and Study 304, with approximately 50 sites expected for each trial [45] Question: Duration of trials and quality of patient selection - Management emphasized that quality of patients and sites is prioritized over speed, with a focus on controlling placebo response [50] Question: Open-label safety study expectations - The open-label study is expected to provide insights into real-world effects of treatment, with various patient subsets being analyzed [62] Question: FDA interactions and protocol amendments - Management confirmed ongoing dialogue with the FDA regarding protocol amendments and emphasized adherence to regulatory approvals [73] Question: Onset of action and differences in study populations - Management acknowledged challenges in transitioning from controlled inpatient studies to outpatient populations, affecting the observed onset of action [76]