Ensysce Biosciences, Inc. (NASDAQ:ENSC), a clinical-stage pharmaceutical company, has recently addressed inquiries from its stockholders and interested parties with an update from its Chief Executive Officer, Dr. Lynn Kirkpatrick. The update covers several key areas including compliance with Nasdaq listing requirements, financial status, and progress in clinical trials for its pain relief solutions.
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Nasdaq Listing Compliance: As of September 30, 2024, Ensysce believes it is in compliance with Nasdaq's stockholders' equity requirements and is preparing for an upcoming hearing to discuss maintaining compliance with both the stockholders' equity and the $1.00 bid price requirements.
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Financial Health: In August, the company completed a financing transaction raising $5 million in gross proceeds and was awarded a $14 million multi-year grant from the NIH to support its initiatives.
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Clinical Trials Progress: Ensysce submitted its PF614-301 Phase 3 Protocol to the FDA on September 19, 2024, for a study designed to evaluate the efficacy and safety of PF614 in treating moderate to severe pain following abdominoplasty. Results are expected by late 2025. The company is also advancing its PF614-MPAR studies, with a kickoff meeting held to prepare for subject enrollment anticipated to begin later this quarter.
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Future Plans: Ensysce is on track to submit its PF614 New Drug Application by 2026, with commercialization expected by the end of that year. The company is also in discussions with potential strategic partners to expand the commercial success of its products.
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Enhancing Shareholder Value: Ensysce continues to execute its clinical and development strategy, achieving significant milestones such as Breakthrough Therapy designation from the FDA and the successful completion of a bioequivalence clinical study for PF614-MPAR.
Ensysce Biosciences is committed to developing safer prescription drugs using its proprietary technology platforms, aiming to minimize the risk of drug abuse and overdose. For more information, visit www.ensysce.com.
