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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 has enrolled its first patients in a Phase 1 clinical study for PF614-MPAR, designed to provide safety and pharmacokinetics data. This product combines PF614, a trypsin-activated oxycodone prodrug, with nafamostat to offer abuse and overdose protection. Dr. Lynn Kirkpatrick highlighted the urgent need to address opioid abuse and overdose deaths, aiming for safer pain management solutions. The clinical trial is seen as a crucial step toward the development of this innovative product, potentially paving the way for future trials.
Ensysce Biosciences has completed a positive safety review for its PF614 opioid study, advancing to the highest dose cohort. The Phase 1b study will evaluate dosing safety and pharmacokinetics compared to OxyContin, with results expected in early 2022. PF614 aims to provide enhanced pain relief while minimizing abuse potential through its Trypsin Activated Abuse Protection technology. The company has bolstered its management team, achieved significant milestones, and secured funding for further clinical initiatives, positioning itself for continued success in the opioid market.
Ensysce Biosciences (NASDAQ: ENSC) reported its Q3 2021 financial results on November 15, 2021. The company completed a $15 million convertible note financing, enhancing its cash position to $6.8 million pre-financing. Key highlights include an increase in federal grants to $1.2 million and a rise in R&D expenses to $1.7 million due to clinical activities related to PF614. However, the company reported a net loss of $17.2 million, contrasting with a net income of $1.6 million in Q3 2020. Ensysce continues to develop opioid abuse deterrents and appointed Dr. Linda Pestano as Chief Development Officer.
Ensysce Biosciences has successfully completed a private placement for $15 million through senior secured convertible notes and warrants. The latest funding round closed on November 5, 2021, with $10 million raised. The convertible notes have a conversion price of $5.87, and the accompanying warrants allow for the purchase of common stock at $7.63. Funds will support the advancement of clinical trial programs, including critical studies related to opioid abuse prevention. This financing strengthens Ensysce's commitment to developing safer prescription drugs.
Ensysce Biosciences has appointed Linda Pestano, PhD, as Chief Development Officer effective October 15, 2021. Dr. Pestano brings over 20 years of experience in drug development and has worked on therapies for various indications. CEO Dr. Lynn Kirkpatrick highlighted her expertise as a boon for advancing their opioid products and addressing concerns in the opioid crisis. Ensysce is focused on developing safer prescription drugs through its proprietary platforms aimed at reducing abuse and overdose.
Ensysce Biosciences has secured a $15 million investment through a securities purchase agreement involving senior secured convertible notes and warrants. The initial $5 million was funded on September 24, 2021. The notes, convertible at $5.87, mature in 21 months, bearing 5% interest. Proceeds will support clinical programs, including studies on opioid treatment. CEO Dr. Lynn Kirkpatrick highlighted this financing as essential for combating the opioid crisis.
Ensysce Biosciences has commenced a second clinical study of PF614, a trypsin-activated opioid designed to deter abuse, with the first cohort enrolled on September 7, 2021. This Phase 1b trial will evaluate PF614's pharmacokinetics and safety, comparing it to OxyContin. The study aims to advance understanding of PF614's potential as a safer pain management option, contributing to solutions for the opioid crisis. Ensysce's innovative approach aligns with pressing healthcare needs, focusing on effective treatments for chronic pain while minimizing abuse risks.
Ensysce Biosciences (NASDAQ:ENSC) has scheduled participation in multiple key industry conferences throughout September 2021. CEO Dr. Lynn Kirkpatrick will present at the 10th Annual Gateway Conference on September 8. Additionally, Ensysce will sponsor a symposium at PAINWeek 2021 on September 9, focusing on next-generation opioids with abuse protection. The company will also engage in one-on-one meetings during Lake Street's Best Ideas Growth Conference on September 14. Ensysce aims to utilize its proprietary technologies to reduce prescription drug abuse and overdose risks.
Ensysce Biosciences (NASDAQ: ENSC, OTC: ENSCW) is sponsoring a symposium at PAINWeek 2021 on September 9, focusing on innovative opioid solutions with built-in abuse and overdose protection. Chaired by Dr. Jeffrey Gudin, the event will showcase advancements in pain management amid the ongoing opioid crisis. Dr. Lynn Kirkpatrick, CEO, emphasizes the company's mission to transform pain treatment and combat prescription drug abuse through proprietary platforms. Ensysce aims to offer safer opioid alternatives to improve patient care and reduce societal impacts.
Ensysce Biosciences reported Q2 2021 financial results, highlighting a successful merger with Leisure Acquisition Corp., providing access to $60 million in capital. Cash reserves reached $8 million. Key programs include PF614 entering Phase 1b and PF614-MPAR™ receiving IND from the FDA. Federal grant funding dropped to $0.4 million from $1.8 million YoY. Net loss increased to $1 million from $0.7 million. The company aims to address opioid use and pain management through its innovative drug platforms.
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