Press Releases

Ensysce Biosciences Announces Strategic Partnership for the Development and Commercial Launch of PF614 and PF614-MPAR

~ $10 Million Commitment from Specialty Drug Manufacturer to Support Commercialization Efforts ~

SAN DIEGO, CA / ACCESSWIRE / December 4, 2024 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or "Company"), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today announced the initiation of a strategic partnership with a leading specialty drug manufacturer for the development and commercial launch of PF614 and PF614-MPAR drug products.

This collaboration underscores a shared commitment to achieving swift regulatory approval and efficient development of the Company's innovative drug products. The strategic partnership will provide Ensysce with the clinical trial material, drug products for regulatory submissions, and initial commercial batches of PF614 and PF614-MPAR. The partner's services will also encompass the complete manufacturing process, including packaging, labeling, and shipment of the products, ensuring a seamless transition from regulatory approval to market entry.

As part of this partnership, the specialty drug manufacturer will take an equity position in Ensysce, facilitating resource allocation to clinical trials and commercialization activities. The agreement also secures key Chemistry Manufacturing and Control (CMC) elements of the New Drug Application (NDA) submission.

Dr. Lynn Kirkpatrick, CEO of Ensysce Biosciences, stated, "This partnership strengthens our ability to deliver quality drug products for clinical and commercial purposes starting with PF614 and PF614-MPAR. It ensures that all aspects of manufacturing, packaging, and distribution are handled efficiently, enabling us to focus on helping patients suffering from severe pain with innovative and safer solutions."

About Ensysce Biosciences

Ensysce Biosciences is a clinical-stage pharmaceutical 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:
MZ Group North America
Shannon Devine
203-741-8811
ENSC@mzgroup.us

SOURCE: Ensysce Biosciences Inc.

Released December 4, 2024