Ensysce Biosciences Announces Partnership to Scale and Manufacture New Drug Candidate

~ Collaboration with Purisys Positions Ensysce to Expedite Lead OUD Candidate, PF9001, to IND Studies ~

SAN DIEGO, June 25, 2024 – Ensysce Biosciences, Inc. (NASDAQ: ENSC) (“Ensysce” or the “Company”), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today announced an agreement with Purisys LLC (“Purisys”) to scale the manufacture of the Company’s lead opioid use disorder (OUD) drug candidate. PF9001, as recently announced, is a novel agent developed with Ensysce’s unique TAAP technology to treat OUD that will potentially decrease the cardiovascular side effects associated with methadone. Purisys brings experience with established manufacturing expertise specializing in commercial scale supply of complex synthetic compounds specifically in controlled substance chemistry.  

Dr. Lynn Kirkpatrick, CEO of Ensysce, said, “As we continue to progress to Phase 3 with our lead candidate to treat severe pain, PF614, we are simultaneously making significant strides advancing our OUD program. We recognize the advantage of being able to expand our pipeline of drug candidates using our TAAP technology and are looking forward to bringing PF9001 into clinical trials in the coming year. We are especially pleased to partner with manufacturing leader Purisys and its skilled team of scientists and engineers who have also made great strides with improving the manufacture of lead product PF614. We appreciate Purisys’ expertise, and we look forward to advancing toward larger non-clinical and clinical studies with PF9001.”

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 (TAAPTM) 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.

About Purisys

Headquartered in Athens Georgia, Purisys is a leading supplier of API CDMO services and pharmaceutical reference standards. Its 17,000-square-foot manufacturing facility and innovation center is staffed by scientists, engineers, and other professionals who have decades of experience in complex high-barrier custom synthetic chemistry. Purisys’ CDMO services are designed to support the development of custom APIs for a wide range of clinical and niche commercial applications. Purisys has specialized capabilities in controlled substance APIs, possessing 6 DEA registrations encompassing 48 drug codes. Purisys stocks a catalog of more than 250 commercial reference standards that support pharmaceutical drug product development and manufacturing.

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:
MZ Group North America
Shannon Devine

Source: Ensysce Biosciences Inc.