• PF614-MPAR recognized as potential medical breakthrough

SAN DIEGO, CA / ACCESSWIRE / February 6, 2024 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or "Company"), a clinical-stage company applying transformative chemistry to improve prescription drug safety, today announced they have been selected to present one of the top 12 best Flash Talks in the Trailblazer Session at the 2024 American Association of Pain Medicine (AAPM) Meeting on March 9^th. Dr. William Schmidt, Chief Medical Officer of Ensysce, will present "Preventing Prescription Drug Overdoses: Clinical development of Trypsin-Activated Abuse Deterrent (TAAP) Opioids with Overdose Protection".

The American Association of Pain Medicine is a leading organization in the country for pain experts and practitioners, with the mission to advance education, advocacy and research to improve the quality of life for people in pain. The flash talk designation is awarded to a small number of programs that convey novel information with great potential and are of interest to pain specialists. Ensysce's novel PF614-MPAR is designed to provide optimal pain relief at prescribed doses yet limit accidental or intentional overdose by ‘shutting down' opioid release if too much active drug is consumed. PF614-MPAR could herald a new class of treatment for the most severe forms of pain and could save lives if approved, as each capsule contains built-in protection against both abuse and overdose which plague traditional opioids. In late January, the Company's PF614-MPAR was granted Breakthrough Therapy designation by the FDA, recognizing its innovative approach to preventing prescription opioid overdoses.

Dr. Lynn Kirkpatrick, PhD, Chief Executive Officer of Ensysce Biosciences, commented, "We are delighted to be recognized by AAPM, an organization which we hold in very high regard. We believe PF614-MPAR is a true game-changer but it's always encouraging to learn that leading external experts share our enthusiasm. Following our constructive End of Phase 2 meeting with the FDA informing the strategic design of the upcoming Phase 3 studies, and recent Breakthrough Therapy Designation of PF614-MPAR, we are encouraged by the AAPM's interest as we accelerate the development of the ‘Next Generation' opioid to treat severe pain layered with overdose protective properties."

Dr. William Schmidt, Chief Medical Officer, added, "Recognition by the AAPM of our unique PF614-MPAR platform is particularly notable, and to be selected as one of the top twelve best topics in the flash talk category is highly encouraging. I look forward to presenting our extremely innovative data to experts and professionals in the pain field. As PF614, our lead opioid with novel abuse protection, continues to move toward approval, we believe the second layer of safety from our MPAR technology will disrupt the opioid market and mitigate the risk of overdose."

About Ensysce Biosciences

Ensysce Biosciences is a clinical-stage company using its proprietary technology platforms to develop safer prescription drugs. Leveraging its Trypsin-Activated Abuse Protection (TAAP^TM) and Multi-Pill Abuse Resistance (MPAR^®) platforms, the Company is developing unique, tamper-proof treatment options for pain that minimize the risk of both drug abuse and overdose. Ensysce's products are anticipated to provide safer options to treat patients suffering from severe pain and assist in preventing deaths caused by medication abuse. The platforms are covered by an extensive worldwide intellectual property portfolio for a wide array of prescription drug compositions. For more information, please visit www.ensysce.com.

Forward-Looking Statements

Statements contained in this press release that are not purely historical may be deemed to be forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. Without limiting the foregoing, the use of words such as "may," "intends," "can," "might," "will," "expect," "plan," "possible," "believe" and other similar expressions are intended to identify forward-looking statements. The product candidates discussed are in clinic and not approved and there can be no assurance that the clinical programs will be successful in demonstrating safety and/or efficacy, that Ensysce will not encounter problems or delays in clinical development, or that any product candidate will ever receive regulatory approval or be successfully commercialized. All forward-looking statements are based on estimates and assumptions by Ensysce's management that, although Ensysce believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Ensysce expected. In addition, Ensysce's business is subject to additional risks and uncertainties, including among others, the initiation and conduct of preclinical studies and clinical trials; the timing and availability of data from preclinical studies and clinical trials; expectations for regulatory submissions and approvals; potential safety concerns related to, or efficacy of, Ensysce's product candidates; the availability or commercial potential of product candidates; the ability of Ensysce to fund its continued operations, including its planned clinical trials; the dilutive effect of stock issuances from our fundraising; and Ensysce's and its partners' ability to perform under their license, collaboration and manufacturing arrangements. These statements are also subject to a number of material risks and uncertainties that are described in Ensysce's most recent quarterly report on Form 10-Q and current reports on Form 8-K, which are available, free of charge, at the SEC's website at www.sec.gov. Any forward-looking statement speaks only as of the date on which it was made. Ensysce undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required under applicable law.

Ensysce Biosciences Company Contact:

Lynn Kirkpatrick, Ph.D.
Chief Executive Officer
(858) 263-4196

Ensysce Biosciences Investor Relations Contact:

Shannon Devine
MZ North America
Main: 203-741-8811
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