Ensysce Biosciences Inc（ENSC）のニュースとイベントENSCEnsysce Biosciences Inc

Ensysce Biosciences Completes Enrollment in PF614-MPAR-102 Clinical Study

Ensysce Biosciences announced completion of enrollment in the final stage of the PF614-MPAR-102 clinical study. The study evaluated its novel MPAR overdose-protection technology. Unlike traditional abuse-deterrent technologies, PF614-MPAR is engineered to actively protect against oral overdose, addressing one of the most persistent risks in opioid therapy. Its proprietary chemical-control mechanism provides therapeutic opioid exposure when used as prescribed and automatically limits additional release when excessive doses are taken. This built-in "safety switch" establishes a new therapeutic paradigm: opioids designed not only for efficacy, but also for controlled exposure under misuse conditions. Part 3 of this second PF614-MPAR study, supported by the National Institute on Drug Abuse, was designed to further characterize the drug's protective profile against a full range of dosing scenarios. Clinical data published to date demonstrates PF614-MPAR maintains consistent therapeutic plasma levels at normal doses while significantly blunting exposure increases at supratherapeutic levels.

Ensysce Completes Acquisition of Cy Biopharma, Secures $43 Million Financing

Ensysce Biosciences has completed the acquisition of Cy Biopharma. Concurrent with the acquisition that brought in $17.1 million in cash from a pre-acquisition convertible note financing, Ensysce entered into a definitive agreement for the sale of Series C non-voting convertible preferred stock in a private placement financing, which is expected to result in gross proceeds to the Company of approximately $21.5 million at the initial close before deducting placement agent fees and other offering and transaction expenses, and includes up to a $38.6 million follow-on tranche that is expected to fund development of CY200 into 2028. The private placement financing was led by Ally Bridge Group and included participation from Perceptive Advisors, Dellora Investments, Ikarian Capital and Adage Capital Partners, L.P. The proceeds from the investment will support the advancement of CY200 as a novel approach to treating CRPS Type 1, which has received U.S. Food and Drug Administration Orphan Drug Designation. The funds are expected to carry CY200 through key clinical milestones, including topline data from a randomized Phase 2 clinical trial assessing the efficacy, safety and tolerability of CY200 for symptom alleviation in participants with CRPS Type 1, and to prepare for registrational development. Importantly, the Company believes the Orphan Drug Designation will provide critical regulatory and commercial advantages. Following completion of the transaction, James Morrison, Founder and CEO of Cy Biopharma, will serve as President of the Company and will join its Board of Directors. The acquisition is structured as a stock-for-stock merger, pursuant to which all outstanding equity interests of Cy Biopharma will be exchanged based on a fixed exchange ratio for an aggregate of 282,122 shares of Series C Preferred Stock. Concurrent with the acquisition, the Company entered into a definitive agreement for a private placement financing to raise an aggregate of approximately $43 million in gross proceeds over two tranches, in which the investors will be issued an aggregate of 120,260 shares of Series C Preferred Stock at a price of $321.79 per share for the initial tranche of 66,811 shares of Series C Preferred Stock, and a price of $402.24 per share for the second tranche of up to 53,449 shares of Series C Preferred Stock. The first tranche of the private placement is expected to close on August 7, 2026, and the Milestone Closing will close subject to achievement of a clinical trial milestone. Concurrently, the Company also resolved all existing contractual matters with a third party in exchange for the conversion of its outstanding Series B Preferred Stock and warrants into common stock and Series C Preferred Stock, subject to beneficial ownership limitations. Subject to Company stockholder approval in accordance with Nasdaq listing rules, each share of Series C Preferred Stock will automatically convert into 1,000 shares of common stock, subject to beneficial ownership limitations. Following stockholder approval, ownership of the Company, on a fully diluted basis not including any shares that may be issued in the Milestone Closing, will be approximately 74.94% for Cy Biopharma's former equityholders, approximately 7.57% for the Company and approximately 17.49% for new investors in the private placement with a combined fully diluted equity value of approximately $122.9 million. The acquisition was approved by the Board of Directors of the Company and the Board of Directors and stockholders of Cy Biopharma. The closings of the acquisition and the private placement are not subject to the approval of the Company's stockholders. The approval of the Company's stockholders is required, among other things, under Nasdaq listing rules in order for the Series C Preferred Stock to be converted into shares of Company common stock, and the Company is required under the terms of the financing to hold a stockholder meeting to obtain this vote.