NEW YORK, Dec. 14, 2022 (GLOBE NEWSWIRE) -- Diamond Equity Research, a leading equity research firm with a focus on small capitalization public companies has initiated coverage of Ensysce Biosciences, Inc. (NASDAQ: ENSC). The in-depth 21-page initiation report includes detailed information on the Ensysce Biosciences’ business model, services, industry, valuation, management, and risks.

The full research report is available here. Highlights from the report include:

• Unique and Extensible Technology Platform - Focusing on chemistry and innovation, Ensysce Biosciences has developed a differentiated technology platform that can potentially enhance the delivery mechanism of drugs that are susceptible to abuse and overdose. Trypsin Activated Abuse Protection (TAAP™) platform allows the creation of a prodrug that remains chemically inert until exposed to Trypsin, an enzyme only present in the small intestine, thus preventing abuse. Multi-Pill Abuse Resistance (MPAR™) platform complements the TAAP™ by providing an extra layer of protection by inhibiting overdose. The platform allows the creation of a combination product (TAAP prodrug + Nafamostat) that leverages the TAAPs mechanism of action to reduce the potential of any overdose. Nafamostat is an enzyme inhibitor that has the potential to suppress the trypsin activation process. Both these platform technologies are controllable (aids in the creation of both IR and ER formulations) with vast applicability that can be applied to numerous drug classes to create much safer and more efficient alternatives.
• Addressing the Opioid Crisis - The opioid crisis continues to remain a public health emergency in the United States, with an increasing number of overdose-related deaths. More than half a million people died due to opioid overdose in the United States during the past decades involving both prescription and illicit opioids. A total of 142.8 million opioid prescriptions were written in 2020, and an estimated 20% of those were accounted for by oxycodone. The addictive and easily manipulative nature of these drugs remains one of the key reasons for this crisis. Opioid analgesics with abuse-deterrent formulations (ADFs) have gained interest in the past five to six years, with FDA encouraging its development to combat the opioid crisis. This has given rise to abuse-deterrent opioids that cannot be manipulated or abused through other means of administration that are not recommended for use. Many of these drug products have either been discontinued or had modest success due to their inability to be fully abuse resistant. There remains a larger unmet need in the treatment of chronic or acute pain, given the lack of safer alternatives. Ensysce, with its innovative and novel approach, can potentially address this high unmet need. In 2021 2.2 million prescriptions of Oxycodone ER were written, leading to sales of approximately $1.3 billion.
• Favorable Clinical Results and Long Patent Life - The primary focus remains to advance its lead pipeline candidate, PF614, and follow-on candidate PF614 MPAR™ through clinical development and towards FDA approval. PF614, A TAAP™ prodrug of oxycodone, is currently in the final stages of the Phase 2 clinical trial. Developed on the back of the TAAP™ platform, PF614 has exhibited slower onset, longer half-life, and a good safety profile in the clinical trial results announced to date. Furthermore, the recently announced topline results of the Human Abuse Potential (intranasal) study indicated the favorable abuse-deterrent ability of the drug. PF614-MPAR™ is currently being evaluated in phase 1 clinical trials in healthy patients. The topline results from the MPAR™ trial indicated that nafamostat reduced the trypsin activation at higher dosages, thus inhibiting oxycodone release and absorption even at higher than prescribed dosage levels. Both these drugs carry a long patent life that is expected to last until 2032 and can be extended by up to five years under the provision of the Hatch-Waxman Act.
• Valuation – Using a risk-adjusted DCF with a discount rate of 15%, we have incorporated the company’s two lead drug candidates, PF614 and PF614-MPAR™, in our valuation estimates, thus yielding a valuation of $29.89 million or $5.70 per share contingent on successful execution by the company.

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 global 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 12/14/2022, the issuer had paid us $35,000 for our services, which commenced 12/14/2022 and is billed annually. 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 12/14/2022. 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 principal. Investors can find various risk factors in the initiation report and in the respective financial filings for Ensysce Biosciences, Inc.

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