Relmada Therapeutics(RLMD) - 2022 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For Q1 2022, total research and development expenses were approximately $25 million, up from $14 million in Q1 2021, primarily due to increased costs associated with the broader clinical program for REL-1017 [24] - General and administrative expenses for Q1 2022 were approximately $13.3 million, compared to $8.4 million in Q1 2021, reflecting an increase of about $4.9 million mainly due to higher stock-based compensation [25] - The net loss for Q1 2022 was $39.7 million, or $1.40 per share, compared to a net loss of $22.2 million, or $1.34 per share, in the same period of 2021 [26] - As of March 31, 2022, cash, cash equivalents, and short-term investments totaled $220.6 million, compared to approximately $211.9 million at December 31, 2021 [26] Business Line Data and Key Metrics Changes - The ongoing RELIANCE Phase 3 trials for REL-1017 are expected to yield clinical data readouts beginning mid-year 2022, with enrollment completion anticipated for RELIANCE III [8][13] - RELIANCE I and RELIANCE II are designed to evaluate REL-1017 as an adjunctive treatment for major depressive disorder (MDD), with both studies including two arms: placebo and 25 milligrams of REL-1017 [15][17] Market Data and Key Metrics Changes - The company is focusing on the potential market for REL-1017, particularly in the adjunctive treatment space where it would be the only antidepressant available, thus allowing for greater pricing power and reduced competition [50] - In the monotherapy market, competition includes generic drugs, which poses challenges in terms of pricing and market share [51] Company Strategy and Development Direction - The company aims to position REL-1017 as a potential Schedule IV drug, with the possibility of it becoming a non-scheduled drug after one to two years of marketing experience [12] - The strategic focus includes maximizing the success of the Phase 3 studies by controlling the placebo effect through careful site and rater selection [34] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the efficacy of REL-1017 based on previous Phase 2 data and the expected outcomes of the ongoing Phase 3 trials [30][33] - The management team is optimistic about the potential for REL-1017 to improve treatment outcomes for patients with MDD, particularly in light of the anticipated clinical data [54] Other Important Information - The company appointed Gino Santini as Corporate Development Strategic Advisor to enhance its strategic capabilities in the biopharmaceutical industry [19] - REL-1017 data were presented at the Ketamine & Related Compounds International Hybrid Conference 2022, highlighting its safety profile [21] Q&A Session Summary Question: What are the expectations for the kinetics of the Phase 3 monotherapy data? - Management indicated that they do not expect any loss of efficacy over time based on strong adjunctive treatment data and experiences with similar compounds [30] Question: What measures have been taken to maximize the success of the Phase 3 study? - The company has implemented strategies to control the placebo effect, including careful site selection and training for raters [34] Question: What is the expected placebo effect in the outpatient setting? - Management expects a placebo delta of 12 points from baseline to day 28, which would indicate a successful trial if REL-1017 performs as anticipated [65] Question: What is the current status of the psilocybin compound? - The psilocybin compound is progressing well, with the company finishing up the manufacturing process [129]