NEW YORK, Aug. 23, 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. Highlights from the note include:
- Pivotal Developments in Clinical Trials, Manufacturing Partnerships, and Regulatory Approvals in the First Half of 2024: Ensysce Biosciences, Inc. has made notable advancements in the first half of 2024. The company provided a comprehensive mid-year update, highlighting significant progress in its key clinical programs. These advancements include preparations for the PF614 Phase 3 clinical trial, the receipt of Breakthrough Therapy designation for the PF614-MPAR program, and the identification of a lead clinical candidate for the opioid use disorder (OUD) program. Additionally, strategic manufacturing partnerships and non-dilutive funding applications underscore Ensysce's commitment to addressing the critical issues of opioid safety and access to pain care:
- PF614 Phase 3 Clinical Trial: Ensysce Biosciences successfully completed an End of Phase 2 meeting with the FDA, receiving valuable guidance on the strategy and design of the upcoming Phase 3 clinical program. This pivotal meeting set the stage for the final phase of clinical trials, crucial for the approval and commercialization of PF614. Furthermore, the company published the bioequivalence results of PF614 to OxyContin, a significant milestone indicating that PF614 can potentially follow the shortened FDA 505(b)(2) regulatory pathway, expediting its development and market entry. To ensure readiness for commercial-scale production, Ensysce has established strategic manufacturing partnerships with Societal CDMO, Porton Pharma Solutions, and Purisys LLC, strengthening its manufacturing capabilities.
- Opioid Use Disorder (OUD) Program: In its OUD program, Ensysce has identified PF9001, a TAAP methadone analogue, as the lead drug candidate. PF9001 demonstrates a lower potential for cardiovascular side effects compared to traditional methadone treatment, addressing a critical need in opioid use disorder therapies. This program continues to receive support from a $15 million multi-year NIDA HEAL award, underscoring the importance and potential impact of Ensysce's work in this area. Additionally, Ensysce has announced an agreement with Purisys LLC to scale the manufacture of PF9001.
- PF614 Phase 3 Clinical Trial: Ensysce Biosciences successfully completed an End of Phase 2 meeting with the FDA, receiving valuable guidance on the strategy and design of the upcoming Phase 3 clinical program. This pivotal meeting set the stage for the final phase of clinical trials, crucial for the approval and commercialization of PF614. Furthermore, the company published the bioequivalence results of PF614 to OxyContin, a significant milestone indicating that PF614 can potentially follow the shortened FDA 505(b)(2) regulatory pathway, expediting its development and market entry. To ensure readiness for commercial-scale production, Ensysce has established strategic manufacturing partnerships with Societal CDMO, Porton Pharma Solutions, and Purisys LLC, strengthening its manufacturing capabilities.
- Valuation: Ensysce is progressively moving towards potential approval and commercialization of PF614. Additionally, the company has made advancements and achieved milestones across other pipeline candidates, including the recent progress and the breakthrough designation of PF614-MPAR, as well as the promising development of its opioid use disorder (OUD) program with the lead candidate PF9001. These achievements underscore Ensysce's commitment to innovation in pain management and opioid safety, potentially positioning it favorably for future growth and profitability. We have updated our financial model to reflect the latest quarterly results and updated share count. Re-assessing the comparable company analysis and accounting for these changes, we reiterate our valuation of $8.00 per share, contingent on successful execution by the company.
- Q2 and H1 2024 Financial Results Update: The company ended H1 of 2024 with cash reserves of $1.04 million compared to $1.1 million at the end of 2023. Total operating cash burn for the first half of 2024 was $5.7 million compared to $6.7 million for the same period in the previous year. In line with the decline in operating burn, total operating expenses decreased to $2.14 million in Q2 2024 compared to $2.78 million in Q2 2023. This decline has been majorly attributed to a decrease in research and development expenditure offset by a slight increase in general and administrative expenses. Net losses for Q2 2024 decreased to $1.97 million compared to $2.23 million for Q2 2023.
- PF614-MPAR Breakthrough Therapy Designation: The PF614-MPAR program achieved a significant milestone by receiving Breakthrough Therapy designation from the FDA, recognizing the innovative potential of the MPAR® overdose protection technology. This elite designation will expedite the development and review process, highlighting the substantial improvement PF614-MPAR could offer over existing therapies. Ensysce has applied for $15 million in non-dilutive grant funding from NIH and NIDA to support three years of continued development, with a potential start date in Q3 2024. The company presented compelling clinical data at the NIH annual HEAL meeting and the AAPM annual meeting, where the PF614-MPAR platform was acknowledged in the Trailblazer Session. Additionally, Ensysce received FDA guidance aimed at potentially reducing the costs associated with the non-clinical program. The company is advancing its collaboration with Quotient Sciences to undertake the second clinical trial, PF614-MPAR-102, expected to commence in Q4 2024.
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 08/23/2024, 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 08/23/2024. 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 loss of their investment. Investors can find various risk factors in the initiation report and in the respective financial filings for Ensysce Biosciences, Inc.
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