Ensysce Biosciences(US:ENSC)2022-04-06 17:57Ensysce Biosciences, Inc. Corporate Update Conference Call Summary Company Overview - Company: Ensysce Biosciences, Inc. (NASDAQ: ENSC) - Industry: Biotech, focusing on opioid drug development - Key Technologies: - TAAP (Trypsin-Activated Abuse Protection): Aims to reduce abuse and overdose of opioids - MPAR (Multi-Pill Abuse Resistance): Designed to prevent overdose when more than the prescribed dose is taken - Investment: Over $100 million since inception, with more than 100 patents issued in 25 countries [5][6] Core Points and Arguments - Focus on Opioid Crisis: Ensysce aims to address the opioid crisis through innovative drug safety technologies [5] - FDA Approval: Received FDA allowance for Investigational New Drug Application (IND) for PF614-MPAR, a combination product for abuse deterrence and overdose protection [8] - Funding: Received $2.8 million from the National Institute on Drug Abuse (NIDA) for Phase 1 study of PF614-MPAR, totaling $8 million in support from NIDA [9] - Public Market Debut: Listing on NASDAQ has provided opportunities for clinical program progression [10] - Management Team Expansion: Appointment of Dr. Linda Pestano as Chief Development Officer to enhance drug development efforts [11] Clinical Program Updates - Phase 1 Study Enrollment: First patients enrolled in the Phase 1 study of PF614-MPAR, which combines abuse and overdose protection [12] - Multi-Ascending Dose Study: Completed first part of clinical study PF614-102, with data expected by the end of Q2 2022 [14] - Bioequivalence Study: Initiated in January 2022, comparing PF614 to OxyContin, with data expected by the end of Q2 2022 [14] - Human Abuse Liability Studies: Two studies planned to evaluate abuse deterrent labeling, with data expected in Q3 2022 and Q1 2023 [15][24] Financial Highlights - Revenue Growth: Federal grant funding increased to $1.6 million in Q4 2021 from $0.4 million in Q4 2020; total funding for 2021 was $3.5 million [17] - Operating Expenses: R&D expenses rose to $2.2 million in Q4 2021 from $1.3 million in Q4 2020; G&A expenses increased significantly due to public company costs [18] - Net Loss: Total net loss for 2021 was $29.1 million, with significant non-cash expenses related to fair value adjustments [20] - Cash Position: Ended 2021 with $12.3 million in cash, up from $0.2 million at the end of 2020 [21] Future Outlook - Upcoming Milestones: Anticipated reporting on three major data milestones by the end of 2022, including clinical study results and safety data [24] - Market Positioning: Ensysce believes it is well-positioned to create long-term shareholder value by addressing prescription drug abuse and expanding its technology platforms [23] Additional Considerations - Supply Chain Issues: Acknowledgment of prevalent supply chain issues affecting drug development timelines [25] - Regulatory Pathway: Ongoing discussions with the FDA regarding the 505(b)(2) regulatory pathway for PF614 [33] This summary encapsulates the key points from the Ensysce Biosciences conference call, highlighting the company's focus on innovative opioid solutions, financial performance, and future milestones.