Relmada Therapeutics(RLMD) - 2021 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For Q3 2021, total research and development expense was approximately $34 million, up from $11.2 million in Q3 2020, primarily due to increased costs associated with the broader clinical program for REL-1017 [28] - General and administrative expenses for Q3 2021 were approximately $8.7 million, compared to $5.9 million in Q3 2020, driven by higher personnel costs, stock-based compensation, and consulting services [29] - The net loss for Q3 2021 was approximately $42.6 million or $2.44 per share, compared to a net loss of $16.9 million or $1.05 per share in Q3 2020 [30] - For the nine months ended September 30, 2021, total research and development expense was approximately $65.3 million, compared to $21.1 million for the same period in 2020 [31] - The net loss for the nine months ended September 30, 2021, was approximately $91.4 million or $5.36 per share, compared to a net loss of $38.7 million or $2.52 per share in the comparable period of 2020 [33] - As of September 30, 2021, the company had cash and cash equivalents of $88.1 million, down from $117.1 million on December 31, 2020 [34] Business Line Data and Key Metrics Changes - The ongoing RELIANCE I and RELIANCE II studies are designed to evaluate REL-1017 as an adjunctive treatment for major depressive disorder (MDD), with both studies including 364 participants across 55 sites [16] - The RELIANCE III study aims to randomize 364 patients and is expected to be completed in Q2 2022, which may reduce the time for potential approval of REL-1017 as a monotherapy for MDD [12][13] Company Strategy and Development Direction - The company is focused on advancing the clinical development program for REL-1017, with data readouts expected in each quarter of 2022 [10][39] - The FDA has confirmed that no two-year carcinogenicity study or TQT cardiac study is required for REL-1017, indicating a favorable regulatory environment for the drug [14][15] - The company aims to conduct a rolling NDA submission, filing the preclinical package and final studies for Phase 3 together to expedite the review process [76] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical program for REL-1017, highlighting the significant market opportunity for the treatment of MDD, which affects over 17 million individuals [24] - The management noted that current antidepressant options have significant side effects and long onset times, emphasizing the need for new treatment options like REL-1017 [25] - The company remains optimistic about the potential of REL-1017 to provide meaningful benefits to patients suffering from MDD [40] Other Important Information - The company presented eight posters at the NEI Congress, showcasing new data from the Phase 2 trial, including improvements in cognition, motivation, and anxiety among patients treated with REL-1017 [35][36] - The RELIANCE development program also includes a long-term open-label safety study, which is ongoing and enrolling participants as planned [18] Q&A Session Summary Question: Can you discuss the additional secondary endpoints for the oxycodone abuse liability study? - Management noted that there was a marginal difference between primary and secondary endpoints, confirming consistency with the primary endpoints [46] Question: What was the conversation with the FDA regarding the upgrade to Phase 3 for RELIANCE III? - The company indicated that they did not have a direct conversation but waited for the FDA's response, which was positive regarding the safety and tolerability of the drug [68][70] Question: Did you see any suicidal ideation in your trial? - Management confirmed that there were no reports of suicidal ideation in any of their studies, emphasizing the potential of NMDA antagonists to reduce such ideation [85][90] Question: What is the significance of the FDQ scale in your studies? - Management explained that patients often take longer to respond to self-administered questionnaires, which is why results may differ from clinician-administered scales [94][96] Question: Will results from RELIANCE III support approval for monotherapy use? - Management believes that if all three studies are positive, one monotherapy study would be sufficient for an indication, but if it is the only positive study, another trial may be needed [105]