New York, NY, March 13, 2025 (GLOBE NEWSWIRE) -- Diamond Equity Research, a leading equity research firm with a focus on small capitalization public companies has released an Update Note on Ensysce Biosciences, Inc. (NASDAQ: ENSC). The update note includes information on Ensysce Biosciences’ business model, services, industry, financial results, valuation, and risks.

The update note is available below.

Ensysce March 2025 Update Note

 Highlights from the note include:                                              

• Ensysce Biosciences Advances Strategic Initiatives and Clinical Programs: Ensysce Biosciences reported robust operational advancements for the fiscal year ended December 31, 2024. The company made substantial progress across several critical strategic and clinical fronts during the year:

• • Strategic Partnership for Manufacturing and Commercialization: During the fourth quarter of FY 2024, Ensysce secured a pivotal strategic partnership with a leading specialty drug manufacturer. This partnership will aim to expedite the manufacturing and commercial launch of Ensysce's primary drug candidates, PF614 and PF614-MPAR. This collaboration emphasizes a joint commitment toward efficient regulatory approval and establishes readiness for commercial supply upon FDA approval, positioning Ensysce effectively in the highly competitive analgesic market.

• • PF614 Clinical Program Update (TAAP™): Ensysce's lead product candidate PF614, an extended-release oxycodone featuring the proprietary Trypsin-Activated Abuse Protection (TAAP™) technology, continued to achieve significant milestones. The TAAP™ technology ensures the opioid is inactive until orally ingested and activated by trypsin enzymes in the small intestine, thereby reducing the potential for abuse. Following constructive feedback from the FDA, Ensysce is actively preparing to initiate its pivotal Phase 3 clinical trial in the second quarter of 2025. This trial is expected to support a New Drug Application (NDA) submission targeted for 2026. Site selection and clinical team appointments are in the final stages, underscoring the company's dedication to swift and successful execution.

• • PF614-MPAR Clinical Program Update (MPAR®): The company also reported notable interim results from the ongoing PF614-MPAR-102 clinical trial. PF614-MPAR combines the TAAP™ prodrug PF614 with a trypsin inhibitor through its Multi-Pill Abuse Resistance (MPAR®) technology. Interim data revealed that the 100 mg dosage form of PF614-MPAR provided effective overdose protection when excessive doses were consumed. Supported by the National Institute on Drug Abuse, the study continues with higher dosage levels and additional safety evaluations. This innovative combination recently earned the FDA’s Breakthrough Therapy designation in January 2024, reflecting its potential to significantly enhance opioid safety profiles. The study is advancing through parts two and three, examining food interactions and conducting ascending dose evaluations.

• • Opioid Use Disorder (OUD) Pipeline Expansion: Ensysce expanded its pipeline through its Opioid Use Disorder (OUD) program, selecting PF9001, a methadone analogue designed using TAAP™ technology. PF9001 aims to mitigate traditional methadone treatments' cardiovascular risks and abuse potential, facilitating safer and broader accessibility to effective OUD therapies. The program, funded through a multi-year Helping to End Addiction Long-Term (HEAL) award, is progressing through preclinical studies intended to pave the way for IND-enabling activities.

Ensysce concluded 2024 well-positioned, having demonstrated substantial advancements in clinical development, strategic partnerships, and pipeline expansion, positioning itself as a potential disruptor in the opioid analgesic and OUD treatment markets.

About Ensysce Biosciences, Inc.

Ensysce Biosciences, Inc., a clinical-stage pharmaceutical company, engages in developing various prescription drugs for severe pain relief. The company’s pipeline of drug candidates is developed on the back of its innovative technology platforms Trypsin Activated Abuse Protection (TAAP™), an abuse-resistant opioid prodrug technology; and Multi-Pill Abuse Resistance (MPAR™).

For more information, visit https://ensysce.com/

About Diamond Equity Research

Diamond Equity Research is a leading equity research and corporate access firm focused on small capitalization companies. Diamond Equity Research is an approved sell-side provider on major institutional investor platforms.

For more information, visit https://www.diamondequityresearch.com.

Disclosures:

Diamond Equity Research LLC is being compensated by Ensysce Biosciences, Inc. for producing research materials regarding Ensysce Biosciences Inc., and its securities, which is meant to subsidize the high cost of creating the report and monitoring the security, however, the views in the report reflect that of Diamond Equity Research. All payments are received upfront and are billed for an annual or semi-annual research engagement. As of 03/13/2025, the issuer paid us $87,500 for our services, which commenced 10/10/2022 and includes an annual fee of $35,000 for the first two years, upfront during each term and quarterly upfront payments of $8,750 for the following year. Diamond Equity Research LLC may be compensated for non-research related services, including presenting at Diamond Equity Research investment conferences, press releases and other additional services. The non-research related service cost is dependent on the company, but usually do not exceed $5,000. The issuer has not paid us for non-research related services as of 03/13/2025. Issuers are not required to engage us for these additional services. Additional fees may have accrued since then. Although Diamond Equity Research company sponsored reports are based on publicly available information and although no investment recommendations are made within our company sponsored research reports, given the small capitalization nature of the companies we cover we have adopted an internal trading procedure around the public companies by whom we are engaged, with investors able to find such policy on our website public disclosures page. This report and press release do not consider individual circumstances and does not take into consideration individual investor preferences. Statements within this report may constitute forward-looking statements, these statements involve many risk factors and general uncertainties around the business, industry, and macroeconomic environment. Investors need to be aware of the high degree of risk in small capitalization equities, including the complete loss of their investment. Investors can find various risk factors in the initiation report and in the respective financial filings for Ensysce Biosciences, Inc. Please review the update report attached for the full disclosure page.

Contact:

Diamond Equity Research
research@diamondequityresearch.com

Attachment

• Ensysce March 2025 Update Note