SAN DIEGO - Ensysce Biosciences Inc. (NASDAQ:ENSC), a clinical-stage pharmaceutical company, has been granted a $14 million award from the National Institutes of Health (NIH) and the National Institute on Drug Abuse (NIDA) to further develop its drug candidate PF614-MPAR. The funding, announced today, will support the Phase 1b clinical trial of PF614-MPAR, an opioid designed to deter abuse and prevent overdose.
The grant will be distributed over approximately three years, enabling the completion of the PF614-MPAR-102 trial. This study aims to build upon the findings of the initial PF614-MPAR-101 trial, which was the first to verify overdose protection offered by the Multi-Pill Abuse Resistance (MPAR®) platform. The continued research is expected to establish PF614-MPAR as the first opioid product to provide oral overdose protection.
PF614-MPAR received Breakthrough Therapy designation from the FDA in January 2024, a status granted to expedite the development of drugs that show potential to improve treatment for serious conditions significantly. Ensysce's CEO, Dr. Lynn Kirkpatrick, remarked on the non-dilutive nature of the award and its validation of the company's work on a novel class of opioids. She emphasized the urgency to address the high unmet need in the market for safer pain medications.
Ensysce's PF614-MPAR is designed to release the optimal amount of medication for pain relief when taken as prescribed. However, it is engineered to limit the release of the active drug in cases of excessive consumption, potentially reducing the risk of accidental or intentional overdose. The opioid crisis remains a critical public health issue, with nearly two overdose deaths per hour, according to the Centers for Disease Control.
The MPAR® technology extends beyond opioids and may improve drug safety across a range of medications. This grant brings the total federal funding awarded to Ensysce for its MPAR and opioid use disorder programs to $40 million.
This information is based on a press release statement from Ensysce Biosciences. The company and its product candidates are subject to risks and uncertainties, including the success of clinical trials, regulatory approval processes, and the commercial potential of the products. Ensysce's forward-looking statements reflect estimates and assumptions that may change over time.
In other recent news, Ensysce Biosciences Inc. has been in the spotlight due to its risk of delisting from the Nasdaq due to non-compliance with the stockholders' equity requirement. However, the company has since regained compliance, ensuring its continued listing on the Nasdaq Capital Market. This development is a significant step for Ensysce Biosciences, reflecting its commitment to meeting regulatory standards.
In addition to this financial news, Ensysce Biosciences has also 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. The company's management is aware of the inherent uncertainties in the clinical development process and the risks associated with potential Nasdaq delisting.
InvestingPro Insights
As Ensysce Biosciences Inc. (NASDAQ:ENSC) continues to progress with its PF614-MPAR opioid candidate, the company's financial metrics and market performance provide a broader context for investors interested in its journey. An InvestingPro Tip highlights that Ensysce holds more cash than debt on its balance sheet, which is a positive sign for investors looking for companies with a solid financial footing to weather research and development phases.
Furthermore, despite the challenges faced by the company, there has been a significant return over the last week, with a 7.53% price total return, indicating some investor optimism in the short term. However, it's important to note that analysts anticipate a sales decline in the current year, which is crucial for investors to consider when evaluating the company's growth prospects.
InvestingPro Data shows a market capitalization of 3.71M USD, reflecting the current valuation of the company in the market. The revenue over the last twelve months as of Q2 2024 stands at 1.44M USD, but with a notable decline of -51.96%, signaling challenges in generating sales growth. Additionally, the gross profit margin for the same period is at a concerning -308.49%, underscoring the difficulties Ensysce faces in maintaining profitability.
For investors seeking a deeper dive into Ensysce's performance and future outlook, InvestingPro offers additional tips, with a total of 12 listed on the platform. These insights could be pivotal in making informed investment decisions about the company.
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