Diamond Equity Research Releases Update Note on Ensysce Biosciences, Inc. (NASDAQ: ENSC)
New York, Aug. 15, 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 updates, management commentary, financial results, valuation, and risks.
The update note is available below.
Ensysce August 2025 Update Note
Highlights from the note include:
- Ensysce Achieves Major Pipeline Milestones in Q2 2025 with PF614 Phase 3 Launch, PF614-MPAR® Overdose Protection Program Advances, and New OUD Patent: In the quarter ended June 30, 2025, Ensysce Biosciences advanced multiple clinical and strategic initiatives that solidify its position in next-generation opioid therapeutics. The period was defined by the launch of the pivotal Phase 3 PF614 trial, full enrollment in Part 2 of the PF614-MPAR-102 study, continued momentum in the OUD pipeline, and a $5.3 million NIDA installment that reinforces financial backing for the company's overdose protection platform.
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- PF614 Phase 3 Trial Initiation: Ensysce commenced its pivotal PF614-301 Phase 3 study in July, evaluating the use of PF614 in managing severe post-surgical pain following abdominoplasty. The trial aims to confirm PF614's ability to provide effective pain relief while reducing abuse risk through its Trypsin-Activated Abuse Protection (TAAP™) technology, which renders oxycodone inactive until enzymatically activated in the small intestine. Conducted in collaboration with Rho, Inc. (a clinical research organization with deep expertise in central nervous system (CNS) disorders and pain studies), the study represents a key milestone toward NDA submission and the introduction of a potentially safer opioid class into the pain management market.
- PF614-MPAR® Overdose Protection Program: During the quarter, the company achieved full enrollment in Part 2 of the PF614-MPAR-102 study, assessing food effects on its MPAR® overdose prevention technology. With FDA Breakthrough Therapy designation and sustained NIDA funding, PF614-MPAR continues to progress toward targeted commercialization as a dual-action therapy offering both pain relief and built-in overdose resistance. The program is expected to move into Part 3 by year-end, with data informing final formulation and regulatory strategy.
- Opioid Use Disorder (OUD) Program Advancement: The company continued developing PF9001, its TAAP™/MPAR®-enabled methadone analogue for OUD, designed to reduce cardiotoxicity and provide overdose protection. During the quarter, Ensysce received a Notice of Allowance from the USPTO covering the composition and use of PF9001, strengthening its patent estate and future competitive position. Supported by a multi-year HEAL grant from NIDA, PF9001 is advancing toward IND-enabling studies.
- Valuation: Ensysce Biosciences maintained steady progress in Q2 2025, launching its pivotal PF614 Phase 3 trial, completing enrollment for PF614-MPAR-102 Part 2, and reporting positive interim results that support the program's potential to address opioid overdose risk. The company also strengthened its intellectual property position with a Notice of Allowance for PF9001, its next-generation OUD candidate, and secured a $5.3M installment from its ongoing $15M NIDA grant, providing non-dilutive funding into 2026. While R&D expenses increased to $1.9M on increased PF614-MPAR research costs, higher federal grant revenue ($1.4M) contributed to a narrower net loss of $1.7M, down from $2.0M a year earlier. Incorporating these results, the updated share count, and a refreshed comparable company analysis, we reiterate our $22.00 per share valuation, contingent on successful execution of the company's clinical and strategic plans.
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 08/15/2025, the issuer paid us $105,000 for our research services, which commenced 10/10/2022 and includes an annual fee of $35,000 for the first two years 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 08/15/2025. 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 update report attached for full disclosures.
Contact:
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