Ensysce Biosciences Bolsters Management Team with Regulatory Expert

Rhea-AI Summary

Ensysce Biosciences (NASDAQ:ENSC) has appointed Tracy Hysong, CCRA as Senior Director of Regulatory Affairs. Hysong, a Certified Clinical Research Associate, brings extensive regulatory experience from UC Davis, where she helped establish the Clinical Trials Office. This strategic hire comes as Ensysce prepares for multiple clinical milestones:

- Initiating Phase 3 pivotal study for PF614 with planned NDA submission in 2026 - Ongoing clinical studies for overdose-protected pain medicine PF614-MPAR - Preparing IND Application and Phase 1 study for novel PF9001 opioid use disorder (OUD) treatment

The appointment strengthens Ensysce's regulatory capabilities as it manages three current INDs and prepares for a fourth IND submission for its OUD treatment.

Positive

• Strategic hire of experienced regulatory expert to strengthen management team
• Company advancing multiple clinical programs simultaneously (PF614, PF614-MPAR, PF9001)
• Clear regulatory timeline with NDA submission planned for 2026

Negative

• None.

Insights

Biotechnology Regulatory Expert

ENSC's hiring of regulatory affairs director strengthens pipeline execution capabilities ahead of critical clinical and regulatory milestones.

This management addition represents a strategic reinforcement of Ensysce's regulatory capabilities at a pivotal moment in their drug development timeline. Tracy Hysong's CCRA certification and experience establishing clinical trial infrastructure at UC Davis directly addresses Ensysce's immediate needs as they advance three parallel development programs.

The company is juggling significant regulatory challenges with their lead asset PF614 entering Phase 3 clinical trials and targeting a New Drug Application (NDA) in 2026. Simultaneously, they're advancing PF614-MPAR (their overdose-protected formulation) through clinical studies and preparing an IND for PF9001, their novel opioid use disorder treatment.

This hire reflects proper resource allocation toward regulatory strategy as Ensysce transitions from early-stage development to late-stage clinical trials. Establishing strong regulatory expertise in-house is critical for navigating the complex FDA approval pathway for novel analgesics, especially those with abuse-deterrent claims which require specialized regulatory approaches. The timing of this addition suggests the company is executing on its development timeline as previously communicated.

The simultaneous advancement of multiple candidates demonstrates pipeline diversification while maximizing their core technology platform. Their focus on both pain treatment (PF614) and opioid use disorder (PF9001) shows commitment to addressing multiple aspects of the opioid crisis with their technology. The regulatory expertise being added should help maintain momentum across these parallel programs while preparing for the critical NDA submission for their lead asset.

~ Advanced Preparation for New Drug Application ~

SAN DIEGO, CA / ACCESS Newswire / May 12, 2025 / 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 abuse and overdose, today announced it has added Tracy Hysong, CCRA as Senior Director of Regulatory Affairs to its management team.

Ms. Hysong is a Certified Clinical Research Associate (CCRA) through the Association of Clinical Research Professionals with years of experience undertaking regulatory activity at the University of California Davis (UC Davis). She helped establish the UC Davis Clinical Trials Office as part of the Clinical and Translational Science Center (CTSC) at UC Davis Health. Her expertise will bolster the regulatory team at Ensysce as the Company focuses on the execution of multiple clinical trials. Over the next year, Ensysce will be initiating its Phase 3 pivotal study to evaluate the efficacy of PF614 and develop its New Drug Application (NDA) for submission in 2026. Additionally, Ensysce has ongoing clinical studies to evaluate a groundbreaking overdose-protected pain medicine, PF614-MPAR, and is preparing for an Investigational New Drug (IND) Application and Phase 1 study of its novel treatment for opioid use disorder (OUD).

Dr. Lynn Kirkpatrick, CEO of Ensysce, added, "The ability to bring Tracy on board at this time is crucial for the Company as it handles three current INDs, prepares to submit a fourth IND for PF9001 for OUD, and plans the regulatory submission of an NDA for PF614. Tracy's experience with clinical trial support and regulatory affairs is perfectly timed to meet the Company's needs going forward. As recently reported, we believe our highly novel treatment of OUD, with both abuse deterrence and overdose protection built in, will be moving through IND-enabling studies and IND submission in the coming year, in addition to the parallel regulatory activities associated with PF614 and PF614-MPAR. We welcome this addition of Tracy to our team."

About Ensysce Biosciences

Ensysce Biosciences is a clinical stage company with a goal of disrupting the analgesic landscape by introducing a new class of highly novel opioids for the treatment of severe pain. 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. 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-K 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
ENSC@mzgroup.us

SOURCE: Ensysce Biosciences Inc.

View the original press release on ACCESS Newswire

FAQ

Who is Tracy Hysong and what is her role at Ensysce Biosciences (ENSC)?

Tracy Hysong, CCRA is the newly appointed Senior Director of Regulatory Affairs at Ensysce Biosciences. She is a Certified Clinical Research Associate with extensive experience from UC Davis's Clinical Trials Office.

What are the main drug candidates in Ensysce Biosciences' (ENSC) pipeline?

Ensysce's main drug candidates include PF614 (entering Phase 3), PF614-MPAR (overdose-protected pain medicine in clinical studies), and PF9001 (novel treatment for opioid use disorder preparing for IND and Phase 1).

When is Ensysce Biosciences (ENSC) planning to submit its NDA for PF614?

Ensysce Biosciences plans to submit its New Drug Application (NDA) for PF614 in 2026, following the completion of its Phase 3 pivotal study.

How many INDs does Ensysce Biosciences (ENSC) currently manage?

Ensysce Biosciences currently manages three INDs and is preparing to submit a fourth IND for PF9001, their opioid use disorder treatment.