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Diamond Equity Research Releases Update Note on Ensysce Biosciences, Inc. (NASDAQ: ENSC)
Globe Newswire 12-Dec-2025 8:00 AM
New York, Dec. 12, 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 research summary below is from a report commissioned by Ensysce Biosciences, Inc. and produced by Diamond Equity Research. The update note includes information on Ensysce Biosciences' business updates, management commentary, financial results, valuation, and risks.
Initiation of PF614 Phase 3 Enrollment Marks a Major Late-Stage Milestone as Ensysce Advances Its Next-Generation Opioid Toward Potential Commercialization: Ensysce Biosciences announced a significant clinical milestone with the enrollment of the first patient in PF614-301, the company's pivotal Phase 3 study evaluating PF614 in moderate to severe post-surgical pain following abdominoplasty. As a next-generation extended-release oxycodone prodrug built on the company's proprietary TAAP™ (Trypsin-Activated Abuse Protection) platform, PF614 is engineered to target delivering strong, consistent analgesia while incorporating a unique enzymatic activation mechanism intended to reduce abuse potential. The Phase 3 trial, a multicenter, randomized, double-blind, placebo- and active-controlled design, will assess PF614's efficacy, safety, and pharmacologic stability under twice-daily dosing, which may offer smoother plasma exposure and improved tolerability relative to traditional opioids. Enrollment has begun at leading clinical research sites, including CenExel JBR (Salt Lake City) and CenExel Atlanta, reflecting strong operational execution as the program progresses. We note that the initiation of Phase 3 enrollment represents a critical inflection point for Ensysce, formally transitioning PF614 into registrational testing and significantly advancing the company's effort to potentially commercialize a safer opioid alternative. Successful execution and Phase 3 outcomes will be pivotal to validating PF614's differentiated profile and unlocking potential value creation as the company moves toward an NDA pathway.
New U.S. Patent Significantly Expands Long-Term Protection for Ensysce's MPAR® Overdose-Prevention Platform, Strengthening Competitive Moat Ahead of Late-Stage Advancement: Ensysce Biosciences announced a notable expansion of its intellectual property portfolio with a new U.S. Patent and Trademark Office Notice of Allowance covering key composition-of-matter and method-of-use claims for the company's MPAR® (Multi-Pill Abuse Resistance) overdose-protection technology. The newly allowed patent, extending exclusivity through 2042, fortifies the core platform supporting PF614-MPAR and broadens protection for enzyme-cleavable prodrug compositions paired with controlled-release nafamostat. MPAR®, which received FDA Breakthrough Therapy designation earlier in 2025, is engineered to automatically limit opioid exposure when doses exceed prescribed levels, while maintaining therapeutic pain relief under normal use. Clinical data from PF614-MPAR have demonstrated this dual effect, validating the platform's potential to materially reduce opioid overdose risk. Beyond opioids, Ensysce is now applying MPAR® to other high-risk drug classes, including amphetamines and methadone, to target safer treatments in pain, ADHD, and opioid use disorder. This patent allowance materially strengthens Ensysce's intellectual property moat, extending long-dated protection around a core technology that could differentiate the company in the evolving landscape of safety-engineered therapeutics. As PF614-MPAR advances toward potential late-stage regulatory interactions, expanded IP coverage enhances both commercial optionality and long-term viability.
FDA Alignment on PF614 Manufacturing Strategy Provides Clear Pathway to Commercial-Scale Production and De-Risks CMC Requirements Ahead of Phase 3 Progress: Ensysce Biosciences reported an important regulatory milestone with the FDA issuing written confirmation agreeing to all elements of the company's proposed Chemistry, Manufacturing, and Controls (CMC) strategy for PF614, its next-generation TAAP™-enabled oxycodone prodrug. The FDA's concurrence on Ensysce's selection of regulatory starting materials and drug-substance specifications establishes a streamlined and predictable path toward commercial manufacturing, an essential requirement as PF614 advances through its pivotal Phase 3 program. The decision enables Ensysce and its commercial manufacturing partner, Purisys, LLC (a Noramco subsidiary), to proceed confidently with scale-up activities in preparation for potential NDA submission. This regulatory clarity significantly de-risks a critical component of PF614's development, particularly given the operational and compliance scrutiny typically associated with opioid manufacturing. FDA alignment on CMC strategy is a meaningful de-risking event, reducing regulatory uncertainty, accelerating readiness for targeted commercial production, and strengthening the chance of a successful approval. For a late-stage opioid candidate differentiated by built-in abuse-deterrent technology, this milestone enhances Ensysce's positioning as it approaches key clinical and regulatory inflection points.
$4 Million Preferred Equity Financing Strengthens Ensysce's Capital Position and Provides Up to $20 Million to Advance PF614 Toward Late-Stage Milestones: Ensysce Biosciences announced the closing of a $4 million convertible preferred stock financing, with the potential to access an additional $16 million over the next 24 months, materially enhancing the company's financial flexibility as it advances multiple late-stage programs. The structure, featuring a fixed conversion price of $2.50 per share, alternative conversion mechanics tied to market pricing, and 50% warrant coverage on each tranche, is an encouraging development that signals strong investor support for the company's long-term strategy. Proceeds from the financing will support the pivotal Phase 3 development of PF614, Ensysce's lead TAAP™-enabled analgesic candidate, as well as general corporate initiatives related to its broader platform of abuse and overdose-resistant pain therapeutics. With PF614 progressing toward anticipated Phase 3 readouts within 18–24 months and the MPAR® program funded through multi-year federal grants, the financing provides critical runway through key value-creating clinical milestones. We note that the capital raise meaningfully strengthens Ensysce's balance sheet during a pivotal period of late-stage execution. Access to up to $20 million in total financing significantly reduces near-term funding risk and supports uninterrupted progress across programs that represent differentiated, safety-driven solutions in the opioid therapeutics market.
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™).
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.
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 12/12/2025, the issuer paid us $113,750 for our research services, which commenced 10/10/2022 and includes an annual fee of $35,000 upfront for the first two years and quarterly upfront payments of $8,750 for the following years. 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 12/12/2025. Issuers are not required to engage us for these additional services. Additional fees may have accrued since then. This report does not explicitly or implicitly affirm that the information contained within this document is accurate and/or comprehensive, and as such should not be relied on in such a capacity. All information contained within this report is subject to change without any formal or other notice provided. 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. This report is based on information we consider reliable, including the subject of the report. This report does not explicitly or implicitly affirm that the information contained in this document is accurate and/or comprehensive, and as such should not be relied on in such capacity. All information contained within this report is subject to change without any formal or other notice provided. 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.
