SAN DIEGO - Ensysce Biosciences Inc. (NASDAQ:ENSC), a clinical-stage pharmaceutical company, has announced a collaboration with Purisys LLC to scale up manufacturing for its opioid use disorder (OUD) drug candidate, PF9001. This partnership is aimed at advancing the drug towards Investigational New Drug (IND) studies.
PF9001, developed using Ensysce's proprietary TAAP technology, is designed to treat OUD with the potential to reduce cardiovascular side effects commonly associated with methadone. With Purisys' expertise in controlled substance chemistry, the collaboration seeks to streamline the production process for PF9001.
Ensysce's CEO, Dr. Lynn Kirkpatrick, expressed optimism about the partnership, stating, "We are especially pleased to partner with manufacturing leader Purisys and its skilled team of scientists and engineers." The company is also progressing with another candidate, PF614, for treating severe pain, which is in Phase 3 development.
Ensysce is focused on creating safer prescription drugs leveraging its Trypsin-Activated Abuse Protection (TAAPTM) and Multi-Pill Abuse Resistance (MPAR®) platforms. These technologies aim to develop tamper-proof treatments that minimize the risk of drug abuse and overdose, providing safer options for patients suffering from severe pain.
Purisys, headquartered in Athens, Georgia, specializes in the development of custom Active Pharmaceutical Ingredients (APIs) for various clinical and niche commercial applications. The company is well-recognized for its capabilities in controlled substance APIs and stocks a catalog of over 250 commercial reference standards that support pharmaceutical drug product development and manufacturing.
This partnership signifies a step forward in Ensysce's efforts to address the challenges of OUD, with the goal of bringing PF9001 into clinical trials within the next year. The press release emphasizes the forward-looking nature of these statements, and there is no guarantee that the clinical programs will be successful or that any product candidate will receive regulatory approval or be commercialized. The information is based on a press release statement from Ensysce Biosciences Inc.
In other recent news, Ensysce Biosciences, a clinical-stage pharmaceutical company, has successfully regained compliance with Nasdaq's equity listing requirements. This development, confirmed by Nasdaq on May 24, 2024, ensures the continued listing of Ensysce's common stock on the Nasdaq Capital Market. The compliance was achieved following the amended Hearing Panel decision from February 26, 2024, which outlined the equity standard in Listing Rule 5550(b)(1).
This achievement marks a significant step for Ensysce Biosciences, highlighting its commitment to meeting regulatory standards. The company continues to advance its clinical trials and secure necessary funding for its operations. While its product candidates are still in clinical stages and have not yet received regulatory approval, the company is aware of the inherent uncertainties in the clinical development process and the risks associated with potential Nasdaq delisting.
These are recent developments in the company's ongoing efforts to create safer treatment alternatives for severe pain and prevent medication abuse-related deaths.
InvestingPro Insights
As Ensysce Biosciences Inc. (NASDAQ:ENSC) embarks on its collaboration with Purisys LLC to enhance the manufacturing capabilities for its drug candidate PF9001, it's important to consider the financial health and market performance of the company. With a market capitalization of just under $4 million, Ensysce is a small-cap company navigating the volatile biopharmaceutical industry. Despite the challenges, Ensysce maintains a stronger liquidity position, holding more cash than debt, which is crucial for funding its ongoing research and development activities, as highlighted by an InvestingPro Tip.
However, the company faces headwinds, with analysts anticipating a sales decline in the current year and expecting net income to drop. This is reflected in the company's significant gross profit margin decline, which stands at -276.18% for the last twelve months as of Q1 2024. Additionally, the stock price has experienced substantial downward pressure, with a year-to-date total return of -50.47% and a one-year price total return of -74.01%, indicating investor concerns about the company's profitability and future growth prospects.
For investors and stakeholders, these financial metrics and market performance indicators are essential for assessing the potential risks and rewards associated with Ensysce. With the company not expected to be profitable this year, according to an InvestingPro Tip, the focus is on the strategic moves Ensysce makes, such as the partnership with Purisys, to navigate its challenges. For those looking to delve deeper into Ensysce's financials and market performance, InvestingPro offers additional insights and tips. There are currently 12 more InvestingPro Tips available for Ensysce, which can be accessed at https://www.investing.com/pro/ENSC. Readers can use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, providing a more comprehensive analysis to make informed investment decisions.
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