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SAN DIEGO - Ensysce Biosciences Inc. (NASDAQ:ENSC), a clinical-stage pharmaceutical company with a market capitalization of $3.8 million, has received the second installment of a $15 million grant from the National Institute on Drug Abuse (NIDA) to advance the development of its opioid product PF614-MPAR. According to InvestingPro data, the company’s stock has declined over 70% in the past year, though it maintains a strong balance sheet with more cash than debt. The $5.3 million funding is part of a three-year grant aimed at reducing the potential for opioid abuse and overdose.
PF614-MPAR, which has been granted Breakthrough Therapy designation by the FDA, employs Ensysce’s proprietary technologies TAAP™ and MPAR® to offer pain relief with a built-in overdose protection mechanism. This feature is designed to function even when doses are taken beyond prescribed amounts.
The first year of NIDA funding, complemented by external capital, supported clinical studies that demonstrated PF614-MPAR’s overdose prevention capabilities. The new phase of funding, starting June 1, 2025, will focus on finalizing the drug formulation, further clinical evaluation, and preparations for commercialization. With a current ratio of 2.5x, InvestingPro analysis shows the company maintains sufficient liquidity to fund its operations, though analysts project a 36% revenue decline for the current fiscal year. Ensysce plans to consult with the FDA in the near future to discuss full development plans based on the data collected so far.
Dr. Lynn Kirkpatrick, CEO of Ensysce, expressed confidence in PF614-MPAR’s potential to provide a safer opioid alternative and noted the significance of the FDA’s Breakthrough Therapy status. She stated that NIDA’s continued support is an endorsement of their mission to deliver innovative solutions for pain management.
Ensysce Biosciences is developing a new class of opioids designed to minimize the risk of drug abuse and overdose while treating severe pain. The company is leveraging its TAAP™ and MPAR® platforms to create tamper-proof treatment options.
The forward-looking statements in the press release describe the company’s expectations for its product candidates, clinical development, regulatory approval, and commercialization. These statements are based on management’s current estimates and assumptions and are subject to inherent uncertainties, risks, and changes in circumstances that may differ from the actual future events or results. InvestingPro subscribers have access to 12 additional key insights about Ensysce’s financial health, valuation metrics, and growth prospects, helping investors make more informed decisions about this volatile biotech stock.
This news is based on a press release statement from Ensysce Biosciences.
In other recent news, Ensysce Biosciences has made several notable announcements. The company plans to raise approximately $2.2 million through the exercise of outstanding warrants, with H.C. Wainwright & Co. serving as the exclusive placement agent. Additionally, Ensysce Biosciences has secured a patent for PF9001, a new treatment for opioid use disorder (OUD) that aims to mitigate the risks associated with traditional methadone therapy. This development highlights the company’s ongoing efforts to innovate in the field of opioid treatment.
Ensysce has also completed Part 1 of a clinical trial for PF614-MPAR, a novel opioid medication designed to provide pain relief with built-in overdose protection. The trial results suggest that PF614-MPAR could reduce overdose risks compared to unprotected opioids. Furthermore, Ensysce recently corrected an omission in its SEC filing, ensuring compliance with regulatory requirements without impacting previously reported financial results.
In another financial move, the company raised approximately $1.1 million through a stock sale, which includes a registered direct offering and a concurrent private placement. The proceeds from these transactions will be used to further develop Ensysce’s proprietary TAAP™ and MPAR® programs. These recent developments underscore Ensysce’s commitment to advancing its pipeline and addressing critical needs in pain management and opioid use disorder treatment.
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