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Associated Press
15-04-2025
- Health
- Associated Press
Ensysce Biosciences Announces Positive Data from Opioid Overdose Protection Study
~ Additional Evidence of PF614-MPAR Overdose Protection after Completion of Part 1 of Clinical Study ~ SAN DIEGO, CA / ACCESS Newswire / April 15, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ('Ensysce' or the 'Company'), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today announced completion of Part 1 of its second clinical trial to evaluate PF614-MPAR for overdose protection. PF614-MPAR-102 demonstrated that the combined Ensysce TAAPTM and MPAR® technologies can deliver strong relief for severe pain yet protect from the risk of excessive doses when consumed accidentally or deliberately. Part 1 of this second study of PF614-MPAR overdose protection confirmed that a 100 mg dosage of PF614-MPAR delivers oxycodone to treat severe pain and provides overdose protection when a greater-than-prescribed dose is consumed. Subjects were studied as their own control and received up to five 100 mg doses of the overdose-protected PF614-MPAR versus the unprotected PF614. The data showed that the maximum amount of oxycodone released from PF614-MPAR, when three or more doses were taken at one time (Cmax) was reduced compared to that released following the consumption of same amount of PF614 alone, evidence of overdose protection. When five doses of PF614-MPAR were administered, overdose protection was appropriately greater than that observed from three dose units. Additionally, safety data from the trial showed that there were no unexpected adverse events from either PF614 or PF614-MPAR. We believe this data, combined with that from a previous study, PF614-MPAR-101, demonstrates overdose protection across the full dosage range of PF614-MPAR planned for commercialization. This complete analysis will be discussed with the FDA in an upcoming meeting focusing on the full development plans for PF614-MPAR. The trial will now continue to enroll Part 2 to examine potential food effect and Part 3 to evaluate repeat dosing of PF614 vs. PF614-MPAR. The aggregate data will allow the Company to focus on perfecting a final drug product to move into commercialization. Dr. Bill Schmidt, Chief Medical Officer of Ensysce, commented, 'These clinical data demonstrate that MPAR® is a vital tool to limit overdoses from prescription medications. Our initial study demonstrated the unique overdose protection built into PF614-MPAR, which is the only opioid product to have been granted FDA's Breakthrough Therapy designation. Our goal of bringing PF614-MPAR and a new generation of safer analgesics to the market to alleviate suffering from severe pain is now closer to the finish line.' Dr. Lynn Kirkpatrick, CEO of Ensysce, added, 'Each phase of our MPAR related clinical studies thus far have provided highly encouraging data supporting the safety features of PF614 and PF614-MPAR that other opioids don't have. We are continuing to quickly execute the final stages of this study with Quotient Sciences and their Translational Pharmaceutics® platform, and we are working with a commercial manufacturing partner to prepare this unique product for the market. We look forward to productive discussions with the FDA to establish our path to registration for the first overdose-protected opioid.' PF614-MPAR 102 Clinical Study Description Clinical study PF614-MPAR-102, 'A Single and Multiple Dose Study to Evaluate the Pharmacokinetics of Oxycodone and PF614 when PF614 Capsule is Co‑Administered with Nafamostat as a Combination of Immediate Release Solution and Extended Release Capsule Formulations (PF614-MPAR) in Healthy Subjects,' was designed to evaluate the full dosage range of PF614-MPAR, study potential food effects, and to conduct a multiple ascending dose study with the final PF614-MPAR combination. About Ensysce Biosciences Ensysce Biosciences is a clinical stage company with a goal of disrupting the analgesic landscape by introducing a new class of highly novel opioids for the treatment of severe pain. Leveraging its Trypsin-Activated Abuse Protection (TAAPTM) and Multi-Pill Abuse Resistance (MPAR®) platforms, the Company is developing unique, tamper-proof treatment options for pain that minimize the risk of both drug abuse and overdose. Ensysce's products are anticipated to provide safer options to treat patients suffering from severe pain and assist in preventing deaths caused by medication abuse. For more information, please visit Forward-Looking Statements Statements contained in this press release that are not purely historical may be deemed to be forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. Without limiting the foregoing, the use of words such as 'may,' 'intends,' 'can,' 'might,' 'will,' 'expect,' 'plan,' 'possible,' 'believe' and other similar expressions are intended to identify forward-looking statements. The product candidates discussed are in clinic and not approved and there can be no assurance that the clinical programs will be successful in demonstrating safety and/or efficacy, that Ensysce will not encounter problems or delays in clinical development, or that any product candidate will ever receive regulatory approval or be successfully commercialized. All forward-looking statements are based on estimates and assumptions by Ensysce's management that, although Ensysce believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Ensysce expected. In addition, Ensysce's business is subject to additional risks and uncertainties, including among others, the initiation and conduct of preclinical studies and clinical trials; the timing and availability of data from preclinical studies and clinical trials; expectations for regulatory submissions and approvals; potential safety concerns related to, or efficacy of, Ensysce's product candidates; the availability or commercial potential of product candidates; the ability of Ensysce to fund its continued operations, including its planned clinical trials; the dilutive effect of stock issuances from our fundraising; and Ensysce's and its partners' ability to perform under their license, collaboration and manufacturing arrangements. These statements are also subject to a number of material risks and uncertainties that are described in Ensysce's most recent quarterly report on Form 10-K and current reports on Form 8-K, which are available, free of charge, at the SEC's website at Any forward-looking statement speaks only as of the date on which it was made. Ensysce undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required under applicable law. Ensysce Biosciences Company Contact: Lynn Kirkpatrick, Ph.D. Chief Executive Officer (858) 263-4196 Ensysce Biosciences Investor Relations Contact: Shannon Devine MZ North America Main: 203-741-8811 [email protected] SOURCE: Ensysce Biosciences press release
Associated Press
31-03-2025
- Business
- Associated Press
Ensysce Biosciences, Inc. Announces $1.1 Million Registered Direct Offering Priced At-The-Market Under Nasdaq Rules
SAN DIEGO, CA / ACCESS Newswire / March 31, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ('Ensysce' or the 'Company'), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today announced that it has entered into definitive agreements, providing the Company with an aggregate gross proceeds of approximately $1.1 million, for the issuance and sale of an aggregate of 315,188 of its shares of common stock (or common stock equivalents in lieu thereof) at a purchase price of $3.49 per share (or common stock equivalent in lieu thereof) in a registered direct offering priced at-the-market under Nasdaq rules. In a concurrent private placement, the Company has also agreed to issue and sell unregistered Series A-5 warrants to purchase up to an aggregate of 315,188 shares of common stock and unregistered Series A-6 warrants to purchase up to an aggregate of 315,188 shares of common stock. The Series A-5 warrants and the Series A-6 warrants will have an exercise price of $3.24 per share and will be exercisable immediately upon issuance. The Series A-5 warrants will have a term of eighteen months from the date of issuance and the Series A-6 warrants will have a term of five years from the date of issuance. The offering is expected to close on or about March 31, 2025, subject to the satisfaction of customary closing conditions. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering. The gross proceeds to the Company from the offering are expected to be approximately $1.1 million, before deducting the placement agent's fees and other offering expenses payable by the Company. The Company currently intends to use the net proceeds from the offering for continued development of its TAAPTM and MPAR® programs and for working capital. The securities offered in the registered direct offering (but excluding the unregistered warrants offered in the concurrent private placement and the shares of common stock underlying such unregistered warrants) are being offered and sold by the Company pursuant to a 'shelf' registration statement on Form S-3 (Registration No. 333-269157), including a base prospectus, previously filed with the Securities and Exchange Commission (SEC) on January 9, 2023 and declared effective by the SEC on January 17, 2023. The offering of the securities to be issued in the registered direct offering are being made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and an accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC's website located at Electronic copies of the final prospectus supplement and accompanying base prospectus may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected]. The offer and sale of the unregistered warrants described above are being made in a transaction not involving a public offering and have not been registered under Section 4(a)(2) of the Securities Act of 1933, as amended (the 'Securities Act') and/or Rule 506(b) of Regulation D promulgated thereunder and, along with the shares of common stock underlying such unregistered warrants, have not been registered under the Securities Act or applicable state securities laws. Accordingly, the unregistered warrants and underlying shares of common stock may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. About Ensysce Biosciences, Inc. Ensysce Biosciences is a clinical-stage company with a goal of disrupting the analgesic landscape by introducing a new class of highly novel opioids for the treatment of severe pain. Leveraging its Trypsin-Activated Abuse Protection (TAAPTM) and Multi-Pill Abuse Resistance (MPAR®) platforms, the Company is developing unique, tamper-proof treatment options for pain that minimize the risk of both drug abuse and overdose. Ensysce's products are anticipated to provide safer options to treat patients suffering from severe pain and assist in preventing deaths caused by medication abuse. For more information, please visit Forward-Looking Statements This release includes 'forward-looking statements,' including statements relating to the registered direct offering, the concurrent private placement and the use of proceeds therefrom. Such forward-looking statements are subject to a number of risks and uncertainties, many of which are not under the Company's control, such as market and other conditions. All statements, except for statements of historical fact, made in this release regarding activities, events or developments the Company expects, believes or anticipates will or may occur in the future, such as statements regarding the consummation of the offering, the satisfaction of closing conditions and the use of proceeds from the offering, are forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934. All forward-looking statements speak only as of the date of this release. Although the Company believes that the plans, intentions and expectations reflected in or suggested by the forward-looking statements are reasonable, there is no assurance that these plans, intentions or expectations will be achieved. Therefore, actual outcomes and results could materially differ from what is expressed, implied or forecasted in such statements. Except as required by law, the Company expressly disclaims any obligation to and does not intend to publicly update or revise any forward-looking statements. The Company cautions you that these forward-looking statements are inherently subject to certain risks and uncertainties, most of which are difficult to predict and many of which are beyond the Company's control. These risks include the risks described under the heading 'Item 1A. Risk Factors' in the Company's Annual Report on Form 10-K for the year ended December 31, 2024. Investor Contact Ensysce Biosciences Company Contact: Lynn Kirkpatrick, Ph.D. Chief Executive Officer (858) 263-4196 Ensysce Biosciences Investor Relations Contact: MZ Group North America Shannon Devine 203-741-8811
