SAN DIEGO - Ensysce Biosciences Inc. (NASDAQ:ENSC) has submitted a protocol for a Phase 3 clinical trial to the FDA, aiming to evaluate the efficacy and safety of its drug candidate PF614 for treating moderate to severe pain after abdominoplasty. The study will compare the analgesic efficacy of PF614 against a placebo and an active comparator at several clinical sites in the United States.
The trial, which is expected to yield results in late 2025, is part of the company's efforts to introduce PF614 as a potential improvement over existing oxycodone products. Ensysce's Chief Medical Officer, Dr. Bill Schmidt, expressed optimism that the trial will reinforce PF614's positive attributes. CEO Dr. Lynn Kirkpatrick highlighted the drug's extended duration, which could address the issue of breakthrough pain between doses, and its reduced potential for abuse.
Ensysce Biosciences focuses on developing prescription drugs with enhanced safety profiles, leveraging its proprietary Trypsin-Activated Abuse Protection (TAAP™) and Multi-Pill Abuse Resistance (MPAR®) platforms. The company aims to offer safer treatment options for severe pain and contribute to reducing medication abuse-related deaths.
The forward-looking statements in the original press release underscore the uncertainties inherent in the drug development process, including the possibility of encountering delays or failing to demonstrate safety and efficacy. The company acknowledges the risks and emphasizes that its product candidates are still in clinical stages and not yet approved for commercialization.
This news is based on a press release statement from Ensysce Biosciences.
In other recent news, Ensysce Biosciences has secured approximately $5 million from stock sales, managed by H.C. Wainwright & Co. The funds are anticipated to be allocated towards the continued development of its TAAP™ and MPAR® programs. Concurrently, the company has received a $14 million grant from the National Institutes of Health for the further development of its opioid product, PF614-MPAR. The funding will support the Phase 1b clinical trial of this opioid, designed to deter abuse and prevent overdose.
The company has also formed a partnership with Purisys LLC to streamline the production process for its opioid use disorder drug candidate, PF9001. This collaboration aims to bring PF9001 into clinical trials within the next year. Despite facing a potential delisting from Nasdaq due to non-compliance with the stockholders' equity requirement, Ensysce Biosciences has successfully regained compliance, ensuring its continued listing on the Nasdaq Capital Market. These recent developments reflect the company's commitment to meeting regulatory standards and advancing its clinical trials.
InvestingPro Insights
As Ensysce Biosciences Inc. (NASDAQ:ENSC) advances its clinical trials for PF614, a closer look at the company's financial health and market performance may offer additional insights. According to InvestingPro data, Ensysce holds a market capitalization of $3.62 million, indicating a relatively small player in the biotech industry. The company's stock is trading near its 52-week low, with a price of $0.33 at the previous close, reflecting a challenging period for the stock.
InvestingPro Tips highlight that Ensysce carries more cash than debt on its balance sheet, which could provide some financial stability as it continues to fund its clinical trials. However, analysts are concerned about the company's future, anticipating a sales decline in the current year and expecting net income to drop. These concerns are underscored by a significant decrease in revenue, with a year-over-year decline of 51.96% in the last twelve months as of Q2 2024. The company's gross profit margin during the same period was deeply negative at -308.49%, indicating cost management challenges.
It's also worth noting that Ensysce does not pay a dividend to shareholders, which is common for companies in their growth phase, especially in the biotech sector where resources are typically reinvested into research and development. Investors interested in a deeper dive into the financial metrics and future outlook for Ensysce can find a wealth of additional InvestingPro Tips at https://www.investing.com/pro/ENSC, including analysis on the company's profitability projections and stock performance history.
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