Relmada Therapeutics(RLMD) - 2021 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For Q1 2021, total research and development expenses were approximately $14 million, up from $4.5 million in Q1 2020, primarily due to increased costs associated with the broader clinical program for REL-1017 [14] - General and administrative expenses for Q1 2021 were approximately $8.4 million, compared to $5.5 million in the same period of 2020, mainly due to an increase in stock-based compensation [15] - The net loss for Q1 2021 was approximately $22.2 million, or $1.34 per share, compared to a net loss of $10.7 million, or $0.72 per share, in Q1 2020 [16] - As of March 31, 2021, the company had cash, cash equivalents, and short-term investments of approximately $102.7 million, down from $117.1 million on December 31, 2020 [17] Business Line Data and Key Metrics Changes - The ongoing RELIANCE program for REL-1017 is designed to evaluate its efficacy as an adjunctive treatment for major depressive disorder (MDD) [6][9] - The first phase 3 trial, RELIANCE I, continues to enroll participants as expected, with additional sites coming online [9] - The second phase 3 trial, RELIANCE II, has also begun enrolling participants, with top-line data expected in the first half of the following year [9] Market Data and Key Metrics Changes - The company is experiencing an increase in patient enrollment due to the rise in depression cases following the COVID-19 pandemic [70] - The REL-1017 development program remains active, with multiple key data results anticipated over the next 12 months [21] Company Strategy and Development Direction - The company plans to initiate a study evaluating REL-1017 as a monotherapy for MDD within the current quarter, with completion anticipated by year-end 2021 [11] - The management emphasizes the importance of differentiating REL-1017 from traditional antidepressants by highlighting its unique mechanism of action and safety profile [60][64] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong cash position supporting the company through multiple anticipated data readouts in the first half of 2022 [17] - The management team remains optimistic about the clinical development of REL-1017 and its potential to address unmet needs in the treatment of depression [21] Other Important Information - The company has presented nine posters across three different scientific congresses, showcasing data that supports the safety and efficacy of REL-1017 [14][18] - The management is actively working on studies to assess the human abuse potential of REL-1017, with plans to complete these studies by the end of 2021 [12][13] Q&A Session Summary Question: Can you describe how similar s-methadone should be to placebo on the likability score? - Management indicated that while oxycodone is expected to be liked by participants, they do not anticipate s-methadone to be significantly different from placebo [25] Question: If the data is positive, would it be fair for investors to assume the second abuse level study will yield similar results? - Management believes that the drug's mechanism of action suggests it is unlikely to show dissociative or hallucination effects, supporting a positive outlook for the second study [27] Question: What is the basis for the DEA's claim regarding dextromethadone's addiction liability? - Management stated that the DEA based its claim on available literature and previous studies conducted by the company [32] Question: How do the studies help from a scheduling perspective? - Management explained that if the data shows a statistically significant difference from oxycodone, it is unlikely to be classified as a Schedule II drug [44] Question: Can you provide details on the monotherapy study and FDA feedback? - Management indicated that the monotherapy protocol is similar to the RELIANCE I and II studies, with a larger patient population expected for recruitment [48] Question: Will the findings from the APA influence the design of the monotherapy trial? - Management confirmed that the findings would not influence the trial design, as they aim to mimic a standard population without pre-selection [53]