Ensysce Biosciences CEO says 2024 ‘will be a pivotal year’ for the company

Ensysce Biosciences issued a letter to shareholders from Chief Executive Officer, Dr. Lynn Kirkpatrick, which read in part, “I am very pleased to provide you with an update on the outstanding progress we made over the last year and to extend sincere thanks from the Ensysce team for your ongoing support. During 2023, our focus was to demonstrate that our innovative approaches to severe pain could be delivered safely and effectively, and with the unique benefit of overdose protection. I believe we achieved that, and we are continuing to move our lead analgesic through to commercialization, as we also add to our pipeline of products to treat pain…Operationally and financially, we took several important steps allowing us to advance the clinical development of our highly unique programs. During 2023, we completed three financing transactions for total gross proceeds of $12 million before fees and expenses, which provided us with necessary funds to continue the advancement of our lead clinical trial programs. As we enter 2024, we are focused on our near-term discussions with the FDA on our Phase 3 protocol design for PF614. Our End of Phase 2 discussions are scheduled with the FDA on January 30, 2024, and will solidify our Phase 3 program that we intend to initiate in the second half of the year. Likewise, we are continuing regulatory discussions with the FDA in February 2024 to aid our future clinical development plans for PF614-MPAR. Ultimately our focus is seeking to move each program through regulatory approval in an expedient fashion through the shortened 505(B)(2) pathway and to expand the use cases of our TAAPTM and MPAR(R) technology platforms. The accomplishments we’ve achieved in 2023, and our tangible forward goals, are a result of the hard work and commitment of our entire team. We are passionate about our mission to deliver new and improved forms of analgesia both in the U.S. and globally and are exploring ways to broaden our pipeline. From presenting our programs at key industry events, to successfully conducting clinical trials, each step has contributed to our long-term success. We are entering 2024 with real excitement for what we believe will be a pivotal year for Ensysce. We thank you, our shareholders, for your support and we thank our employees for fueling the direction of our clinical, operational, and financial execution. We look forward to sharing our accomplishments in the coming year as we strive to create value for our shareholders, employees, and communities, and we thank all of you for your dedication to our mission.”