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SAN DIEGO - Ensysce Biosciences Inc. (NASDAQ:ENSC), currently trading at $1.96 and showing signs of being undervalued according to InvestingPro Fair Value metrics, has concluded Part 1 of its second clinical trial for PF614-MPAR, a novel opioid medication designed to provide severe pain relief with built-in overdose protection, the company announced today. The study reportedly showed that PF614-MPAR, which combines Ensysce’s TAAP™ and MPAR® technologies, could deliver effective pain relief while reducing the risk of overdose, even when higher-than-prescribed doses are consumed.
The clinical trial, named PF614-MPAR-102, tested a 100 mg dosage of PF614-MPAR against the same dosage of unprotected PF614. The results indicated that the maximum concentration of oxycodone released from the protected PF614-MPAR was lower than its unprotected counterpart, suggesting overdose protection. The safety data collected during the trial did not reveal any unexpected adverse events.
According to Dr. Bill Schmidt, Chief Medical Officer of Ensysce, these results demonstrate the importance of MPAR® technology in preventing overdoses from prescription medications. Dr. Lynn Kirkpatrick, CEO of Ensysce, expressed optimism about the potential of PF614-MPAR to offer safer pain treatment options and the company’s ongoing discussions with the FDA regarding the drug’s development path. The company maintains a strong liquidity position with a current ratio of 2.42 and more cash than debt on its balance sheet, according to InvestingPro data.
The trial will progress with Part 2 to investigate the potential effects of food on the drug’s absorption and Part 3 to evaluate repeated dosing. The aggregate data from these trials will guide the finalization of the drug product for commercialization.
Ensysce Biosciences is a clinical-stage pharmaceutical company focused on creating opioids for severe pain treatment that minimize the risk of abuse and overdose. PF614-MPAR has been granted the FDA’s Breakthrough Therapy designation, highlighting its unique overdose protection feature.
The company’s forward-looking statements caution that the product candidates are still in clinical trials and not yet approved. As such, there is no guarantee of successful safety and efficacy outcomes, regulatory approval, or commercial success. While Ensysce’s revenue grew by 133% in the last twelve months, analysts don’t expect profitability this year, according to InvestingPro, which offers 12 additional investment insights for this stock. Ensysce is continuing its clinical development efforts and preparing for potential commercialization.
This news is based on a press release statement from Ensysce Biosciences.
In other recent news, Ensysce Biosciences announced a correction to its Annual Report filing with the Securities and Exchange Commission (SEC). The correction involved the inclusion of references to two Registration Statements on Form S-3, which were omitted in the original document. Ensysce confirmed that this procedural update does not impact any financial results or disclosures previously reported for the fiscal year ended December 31, 2024. Additionally, Ensysce Biosciences has raised approximately $1.1 million through a stock sale, consisting of a registered direct offering and a concurrent private placement. The company plans to use the net proceeds to further develop its TAAP™ and MPAR® programs and for working capital.
The fundraising was facilitated by H.C. Wainwright & Co., serving as the exclusive placement agent. In another development, Ensysce reported positive interim data from a clinical trial of its drug candidate PF614-MPAR, which showed significant overdose protection when subjects consumed more than the prescribed dose. This trial, supported by a $14 million award from the National Institute on Drug Abuse, will continue to assess potential food effects and repeat dosing. The FDA has previously granted PF614-MPAR Breakthrough Therapy designation, recognizing its unique overdose protection.
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