Ensysce Biosciences Inc Stock Price, News & Analysis

Ensysce Biosciences (NASDAQ:ENSC), a clinical-stage pharmaceutical company focused on developing innovative severe pain relief solutions while minimizing opioid abuse and overdose risks, has announced its participation in the 37th Annual ROTH Conference.

The conference will take place from March 16-18, 2025, at the Laguna Cliffs Marriott Resort in Dana Point, CA. The company's leadership team, including CEO Dr. Lynn Kirkpatrick, CFO Dave Humphrey, and CCO Geoff Birkett, will be available for one-on-one investor meetings throughout the event.

Additionally, management will participate in a fireside chat on Tuesday, March 18th at 11:30am PT. Investors interested in scheduling meetings can contact Investor Relations at ENSC@mzgroup.us or their ROTH representative.

Ensysce Biosciences (NASDAQ: ENSC) CEO Dr. Lynn Kirkpatrick and Creighton University's Dr. Neel Pathak discussed innovative solutions to the opioid crisis in a Today's Marketplace interview. The company is developing next-generation opioids using 'clever chemistry' to address the needs of approximately 3 million annual patients requiring opioid pain management.

The company's approach involves chemically modifying oxycodone to make it inactive unless taken orally, reducing abuse potential. The medication includes built-in safeguards against overdose, preventing release if more than prescribed dosage is ingested, while maintaining pain relief efficacy.

The modified oxycodone has received both FDA Fast Track and Breakthrough Therapy designations, recognizing the medical need and improvement over existing therapies. This development addresses the dual challenges of providing necessary pain treatment while meeting regulatory requirements to restrict opioid use.

Ensysce Biosciences (NASDAQ:ENSC) reported positive progress in its clinical trial evaluating PF614-MPAR for overdose protection. The study demonstrated that a 100mg dosage provides overdose protection when consumed above prescribed amounts, with successful enrollment in the highest dosing cohort of 5x the 100mg dose unit.

The trial has shown adverse events, confirming the favorable safety profile of PF614 and PF614-MPAR as novel opioids for severe pain treatment. The FDA granted Breakthrough Therapy designation to PF614-MPAR in 2024, recognizing its unique position as an opioid with oral overdose protection.

The company believes its products will address an unmet need in severe and chronic pain management, particularly following recent FDA approval of NaV1.8 inhibitors for moderate pain treatment.

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.