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Ensysce Biosciences, Inc. (NASDAQ: ENSC) is a San Diego-based clinical-stage biotech company specializing in the development of safer prescription drugs using its proprietary technology platforms. The company focuses on creating new, tamper-proof opioids that aim to reduce drug abuse and prevent overdoses. Ensysce leverages its Trypsin-Activated Abuse Protection (TAAP™) and Multi-Pill Abuse Resistance (MPAR®) platforms to develop innovative pain relief options with a lower risk of misuse.
The company’s core projects include two key drug platforms: the TAAP technology, which activates upon ingestion to release pain medication, and the MPAR technology, designed to prevent overdose by inhibiting further release of the drug when excess doses are consumed. These platforms are supported by global intellectual property protection, ensuring a wide array of prescription drug compositions.
Recent milestones include the FDA’s Breakthrough Therapy designation for PF614-MPAR, a combination product designed to provide overdose protection alongside effective pain relief. This designation accelerates the drug’s development and review process, highlighting its potential to offer substantial improvements over existing therapies. Ensysce’s lead candidate, PF614, is currently in Phase 3 clinical development, having demonstrated efficacy and safety in previous trials.
In terms of financial health, Ensysce has shown stability, with recent funding from federal grants and warrant exercises supporting ongoing research and development. The company's collaboration with Quotient Sciences aims to further optimize their PF614-MPAR drug product, enhancing its effectiveness and safety profile.
Ensysce is also expanding its product pipeline to address opioid use disorder (OUD) with PF9001, a TAAP-based candidate that has shown promise in reducing cardiovascular side effects compared to traditional treatments. Supported by a multi-year HEAL grant from the NIH and NIDA, this candidate is poised to enter human clinical studies within the next 12 to 18 months.
For more detailed information about Ensysce Biosciences, Inc. and its innovative projects, please visit www.ensysce.com.
Ensysce Biosciences (NASDAQ:ENSC) announced positive interim data from its Phase 1b clinical trial (PF614-MPAR-102) evaluating PF614-MPAR for overdose protection. The study demonstrated that the 100 mg dosage form provides significant overdose protection when taken in greater-than-prescribed doses.
The trial showed subjects receiving the MPAR product had a significantly lower (p=0.0019) total maximum blood concentration of oxycodone compared to PF614 alone. At single 100 mg doses, both formulations showed no difference in Cmax values (p=0.523), with no unexpected adverse events reported.
The study follows PF614-MPAR's FDA Breakthrough Therapy designation in 2024 and a $14 million multi-year NIDA award. The trial will continue with final cohorts in Part 1, followed by food effect studies in Part 2, and repeat dosing evaluation in Part 3.
Ensysce Biosciences (NASDAQ:ENSC) reported significant progress in 2024 for its innovative pain relief solutions. Key achievements include receiving FDA Breakthrough Therapy designation for PF614-MPAR, an opioid with overdose protection, and advancing their lead product PF614, a tamper-resistant extended-release oxycodone.
The company completed an End of Phase 2 FDA meeting for PF614 and plans to commence Phase 3 trials in Q2 2025. They also initiated a Phase 1b study for PF614-MPAR and selected PF9001 as their lead candidate for Opioid Use Disorder treatment.
Financial highlights include securing $4.7 million through a warrant inducement in February, $5 million in August, and receiving a $14 million NIH grant for PF614-MPAR development. The company aims to submit a New Drug Application for PF614 in 2026.
Ensysce Biosciences (NASDAQ:ENSC) has regained full compliance with Nasdaq listing requirements. The company received notice on December 20, 2024, confirming its compliance with the minimum bid price requirement (Rule 5550(a)(2)). This follows their previous compliance with the stockholders' equity requirement (Rule 5550(b)(1)). Having met all requirements outlined in the Nasdaq Hearings Panel decision from November 5, 2024, ENSC will continue trading on The Nasdaq Capital Market.
Ensysce Biosciences (NASDAQ:ENSC) has secured a commitment for future supply of GMP nafamostat from Aurore Life Sciences. This agreement is important for PF614-MPAR, the company's overdose protection drug product, as nafamostat is a vital component. The partnership allows Ensysce to reference Aurore's Drug Master File and fully secures the supply chain for PF614-MPAR, which is currently advancing through clinical development. Additionally, the company has initiated other programs using nafamostat as a single agent for various indications, which will also benefit from this supply agreement.
Ensysce Biosciences (NASDAQ:ENSC) has announced a strategic partnership with a leading specialty drug manufacturer for the development and commercial launch of PF614 and PF614-MPAR drug products. The partnership includes a $10 million commitment and involves the manufacturer taking an equity position in Ensysce.
The collaboration will provide Ensysce with clinical trial material, drug products for regulatory submissions, and initial commercial batches. The partner will handle the complete manufacturing process, including packaging, labeling, and shipment. This partnership secures key Chemistry Manufacturing and Control (CMC) elements for the New Drug Application (NDA) submission, supporting the company's goal of achieving regulatory approval for their innovative pain relief solutions.
Ensysce Biosciences (NASDAQ:ENSC) has announced a 1-for-15 reverse stock split effective December 6, 2024, at 12:01 a.m. Eastern Time. The company's stock will continue trading under the symbol 'ENSC' with a new CUSIP number 293602 504.
The primary purpose of this reverse split is to increase the bid price of the company's common stock to meet Nasdaq's minimum bid requirement of $1.00 per share for continued listing. Every 15 shares will be automatically combined into 1 share, with fractional shares rounded up to the nearest whole number. Stockholders' proportional ownership will remain unchanged, except for minor adjustments due to fractional share treatment.
Ensysce Biosciences (NASDAQ:ENSC) has initiated dosing in the PF614-MPAR-102 study, marking a significant milestone for its breakthrough therapy-designated opioid drug. The trial aims to evaluate the pharmacokinetics of oxycodone and PF614 when co-administered with nafamostat. The study received a $14 million multi-year award from NIDA and expects early interim data in Q1 2025. The three-part trial will assess the full dosage range, food effects, and conduct multi-ascending dose studies of PF614-MPAR, which is designed to reduce deliberate and accidental overdoses in severe pain treatment.
Ensysce Biosciences (NASDAQ:ENSC) reported Q3 2024 financial results, highlighting a $14 million NIH grant for PF614-MPAR development and the initiation of its second clinical trial. The company submitted a pivotal Phase 3 protocol for PF614 to FDA review. Cash position improved to $4.2 million from $1.1 million at 2023-end. Q3 showed net income of $0.7 million, compared to a $2.7 million loss year-over-year, primarily due to increased federal grant funding of $3.4 million. R&D expenses decreased to $1.7 million from $1.9 million, while G&A expenses slightly declined to $1.1 million.
Ensysce Biosciences (NASDAQ:ENSC) has received a positive determination from Nasdaq regarding its listing status. The company has been granted an extension until November 14, 2024, to demonstrate compliance with the equity requirement by filing its Form 10-Q. Additionally, Nasdaq extended the deadline to December 19, 2024, for meeting the Minimum Bid Price requirement and other applicable conditions to maintain its listing on The Nasdaq Capital Market.
Ensysce Biosciences (NASDAQ:ENSC) announced its leadership team's participation in the 18th Annual Pain Therapeutics Summit on October 28-29, 2024, in Boston. Dr. Lynn Kirkpatrick, CEO, will present "When All You Have is a Hammer ... A New Approach to Soften the Blow" on October 28th at 1:00 PM ET. She will discuss Ensysce's TAAP™ and MPAR® opioid classes, including PF614 and PF614-MPAR, which aim to provide effective pain relief with reduced abuse potential and overdose protection.
Dr. William Schmidt, CMO, will serve as Chairperson for the second consecutive year, providing opening remarks on both days. The summit brings together leaders in advanced medicine, science, academia, and government to discuss the latest advances in novel pain therapies development.
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