New York, NY, Aug. 29, 2024 (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 here.

Ensysce August 2024 Note

Highlights from the note include:

• NIH and NIDA Award $14 Million Grant to Ensysce Biosciences for Opioid Development with Overdose Protection: Ensysce Biosciences has received a $14 million grant from the National Institutes of Health (NIH) and the National Institute on Drug Abuse (NIDA) to support the clinical development of PF614-MPAR, an innovative opioid designed to reduce the potential for abuse and prevent overdose. This grant, part of a three-year funding initiative, will facilitate the Phase 1b clinical trial, PF614-MPAR-102, which aims to further develop the product based on outcomes from the initial PF614-MPAR-101 study that confirmed its overdose protection capabilities. The funding, which brings the total federal support for this project to $40 million, follows the FDA’s Breakthrough Therapy designation received in January 2024. This designation facilitates frequent interactions with the FDA, ensuring a streamlined path to a potential approval. PF614-MPAR (Multi-Pill Abuse Resistance) is engineered to potentially deliver effective pain relief at therapeutic doses while automatically limiting opioid release when excessive amounts are consumed, thereby addressing severe pain management needs without the common risks associated with traditional opioids. Importantly, the MPAR® technology also holds the potential for broadening safety applications beyond opioids, suggesting possible enhancements in drug safety for various pharmaceuticals. This grant emphasizes a significant federal commitment to combating the public health crisis of opioid overdose, which claims nearly two lives per hour, according to the Centers for Disease Control (CDC).
• Secures IRB Approval to Advance MPAR Study with Federal Support: Ensysce Biosciences, Inc. has received Investigational Review Board (IRB) approval for its next critical study of PF614-MPAR, a novel opioid designed to combat abuse and prevent overdose. The approved protocol, PF614-MPAR-102, involves a detailed pharmacokinetic evaluation of oxycodone and PF614 when co-administered with Nafamostat in both immediate-release solutions and extended-release capsule formulations. This study, conducted in collaboration with Quotient Sciences using their Translational Pharmaceutics® platform, is a continuation of Ensysce's efforts to develop safer opioid alternatives, supported by a $14 million federal grant from the National Institutes of Health (NIH) and the National Institute on Drug Abuse (NIDA). The trial is scheduled to commence immediately, with initial data expected by mid-2025. The federal backing signifies strong government support for Ensysce’s innovative approach, reflecting confidence in the company's potential to bring safer therapeutic solutions to 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™).

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 08/29/2024, the issuer had paid us $70,000 for our research services, which commenced 10/10/2022 and is billed annually as $35,000 fee. 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 08/29/2024. 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 potential loss of their investment. Investors can find various risk factors in the initiation report and in the respective financial filings for Ensysce Biosciences, Inc. Investors can find full disclosures in the update note.

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