Business
Ensysce Biosciences Provides Business Update and Reports Fourth Quarter and Full Year 2021 Financial Results
~ Corporate Update Call to be Held Wednesday, April 6, 2022 ~ SAN DIEGO, March 31, 2022 (GLOBE NEWSWIRE) -- Ensysce Biosciences, Inc. (“Ensysce” or the
About this update from Ensysce Biosciences, Inc.
[{"type":"text","content":"~ Corporate Update Call to be Held Wednesday, April 6, 2022 ~\nSAN DIEGO, March 31, 2022 (GLOBE NEWSWIRE) -- Ensysce Biosciences, Inc. (“Ensysce” or the “Company”) (NASDAQ: ENSC, OTC: ENSCW), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety and performance with a current focus on reducing abuse and overdose, today reported financial results for the fourth quarter and full year 2021. Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, commented, “Following the successful completion of our convertible note financing of $15 million, providing the necessary funds to advance our clinical trials, the year concluded with an exceptional Company milestone as the first patients were enrolled in the Phase 1 study of PF614-MPAR™, the first product utilizing our MPAR™ platform designed to reduce drug overdose. “Subsequently, we initiated and recently concluded, the final dosing in the Bioequivalence (BE) trial of our TAAP™ opioid, PF614. We believe that the BE study data, expected to be available in the second quarter, will position PF614 as our first commercial candidate, fueling our ability to bring a unique pipeline of products to the market aligned with our mission of helping millions suffering with severe pain.” Dr. Kirkpatrick concluded, “Regarding our financial results, it’s important to note that our net loss for the full year consisted of significant non-cash expenses, including $17.9 million related to fair value accounting for warrants and convertible notes. Cash used in operating activities during 2021 totaled $8.2 million.” TAAP™ (Opioid Abuse Deterrent Program) Updates On March 21, 2022, the Company concluded the clinical treatment of the Bioequivalence (BE) portion of the PF614-102 trial, which is studying the novel TAAP™ opioid, PF614. This followed the successful completion of the multi-ascending twice daily dosing part of the study in December 2021.BE data from the PF614-102 study is expected to be available by the end of the second quarter 2022. The Company believes that the data will support the 505(b)(2) regulatory path for clinical development of PF614, an abbreviated pathway to FDA approval.Human abuse liability (HAL) studies to determine labeling claims for PF614 are scheduled to initiate in the second quarter of 2022.PF614 is designed using the abuse protect...