SAN DIEGO - Ensysce Biosciences Inc. (NASDAQ:ENSC), a clinical-stage pharmaceutical company, has announced the receipt of a $14 million federal grant to support the next clinical trial of its opioid product PF614-MPAR, which aims to offer severe pain relief with reduced abuse and overdose potential. The Investigational Review Board approved the study protocol, titled "A Single and Multiple Dose Study to Evaluate the Pharmacokinetics of Oxycodone and PF614 when PF614 capsule is Co-Administered with Nafamostat."
The company's collaboration with Quotient (OTC:QTNTQ) Sciences, utilizing their Translational Pharmaceutics platform, will continue in this second clinical study of MPAR. Dr. Bill Schmidt, Chief Medical Officer at Ensysce, stated that the protocol's approval is a significant step in completing the clinical development of PF614-MPAR. He highlighted that this opioid is the only one to be designated as Breakthrough Therapy by the FDA, a status given to less than 300 drugs since 2012.
Ensysce's CEO, Dr. Lynn Kirkpatrick, expressed satisfaction with the IRB's approval, which allows the commencement of the second clinical study of PF614-MPAR. The National Institute on Drug Abuse supports the program, and the grant will enable the completion of this trial and necessary non-clinical studies. The Breakthrough Therapy designation also allows for frequent interactions with the FDA, which is expected to smooth the path to product registration. The first data from the three-part trial is anticipated in mid-2025.
Ensysce Biosciences is focused on developing safer prescription drugs through its proprietary TAAP™ and MPAR® platforms, aiming to provide tamper-proof pain treatment options that minimize the risk of drug abuse and overdose. The company's products are intended to offer safer solutions for patients with severe pain and contribute to reducing medication abuse-related deaths.
The forward-looking statements in the press release reflect the company's expectations and are subject to risks and uncertainties that may cause actual results to differ. These statements are based on current estimates and assumptions and are not guarantees of future performance. This news is based on a press release statement.
In other recent news, Ensysce Biosciences has made significant strides in its operations. The company has received a substantial $14 million grant from the National Institutes of Health (NIH) for the development of its opioid research drug, PF614-MPAR. The funding will support the Phase 1b clinical trial of PF614-MPAR, an opioid designed to deter abuse and prevent overdose. This research is expected to establish PF614-MPAR as the first opioid product to provide oral overdose protection.
Ensysce Biosciences has also regained compliance with Nasdaq's equity listing requirements, ensuring its continued listing on the Nasdaq Capital Market. This development is a significant step for the company, reflecting its commitment to meeting regulatory standards.
Moreover, the company has announced a collaboration with Purisys LLC to advance its opioid use disorder (OUD) drug candidate, PF9001, towards Investigational New Drug (IND) studies. The partnership is focused on streamlining the production process for PF9001, a drug developed using Ensysce's proprietary TAAP technology. These are the latest developments in Ensysce Biosciences' ongoing efforts to create safer prescription drugs and address the challenges of OUD. Despite these advancements, it's important to note that the company's product candidates are still in clinical stages and have not yet received regulatory approval.
InvestingPro Insights
Amidst the clinical advancements of Ensysce Biosciences Inc. (NASDAQ:ENSC), investors and stakeholders are closely monitoring its financial health and market performance. According to InvestingPro, Ensysce holds a stronger liquidity position with more cash than debt on its balance sheet, which can be crucial for funding ongoing clinical trials and operations. Additionally, despite the challenges faced in the pharmaceutical industry, Ensysce has seen a significant return over the last week, indicating a potential uptick in investor confidence following recent developments.
However, the company's financial metrics reflect some concerns. The market capitalization of Ensysce stands at a modest $5.24 million, and the company has witnessed a sharp revenue decline of nearly 52% in the last twelve months as of Q2 2024. This contraction is mirrored in the quarterly figures, with revenue growth plummeting by approximately 63% in Q2 2024. Moreover, the gross profit margin has been deeply negative at -308.49%, underscoring the cost challenges the company faces.
InvestingPro Tips also highlight that analysts are not optimistic about the company's profitability in the near term, with expectations of a sales decline in the current year and an anticipated drop in net income. These factors, combined with the absence of dividend payments to shareholders, paint a cautious picture for potential investors.
For those considering an investment in Ensysce, further detailed analysis and additional InvestingPro Tips are available. There are 12 more tips listed on InvestingPro's platform, providing a comprehensive view of the company's financials and market performance.
For more in-depth insights and additional InvestingPro Tips on Ensysce Biosciences, interested parties can visit https://www.investing.com/pro/ENSC.
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