Ensysce Biosciences (NASDAQ:ENSC) said it has completed its acquisition of Cy Biopharma and secured financing intended to advance CY200, a botanical psilocybin extract being developed for complex regional pain syndrome, or CRPS.
Chief Executive Officer Dr. Lynn Kirkpatrick said the company’s board reviewed strategic alternatives before determining that the Cy Biopharma acquisition offered the most significant value-creation opportunity considered. She cited the potential synergies between the companies and clinical data supporting CY200 as factors behind the decision.
Financing Supports Phase II Program
Ensysce said the transaction included financing of up to $77 million. The package includes a $21.5 million private placement through sales of Series C non-voting convertible preferred stock to institutional investors, $17.1 million of Cy Biopharma cash and cash equivalents from a pre-acquisition convertible note financing, and up to an additional $38.6 million tied to achievement of a clinical-trial milestone.
The financing was led by Ally Bridge Group, with participation from Perceptive Advisors, Dellora Investments, Ikarian Capital and Adage Capital Partners L.P.
In further details on the transaction structure, Kirkpatrick said Ensysce entered into a definitive agreement for the preferred-stock private placement concurrent with the acquisition closing. She said the private placement resulted in gross proceeds of about $38.6 million before transaction expenses.
The company expects its pro forma cash position to fund operations into late 2027. That funding is intended to support anticipated catalysts, including top-line Phase II data for CY200. Ensysce said the data could trigger a second investment of up to $38.6 million, which it expects could extend activities through 2028.
Kirkpatrick said proceeds are intended primarily to advance CY200 through key clinical milestones and prepare the program for registrational development. The company said it deliberately sized the private placement to support the immediate objective of running the Phase II trial while maintaining financial discipline.
CY200 Targets CRPS Type One
CY200 has received FDA Orphan Drug Designation for CRPS, according to Ensysce. The company said it believes the designation offers regulatory and commercial advantages, including opportunities for closer engagement with the FDA and, if approved, a period of U.S. market exclusivity.
Langford described CRPS as one of the most severe chronic pain conditions. Patients may experience pain disproportionate to an injury, as well as swelling, changes in skin temperature and color, and progressive loss of function in an affected limb, he said.
Current management can include opioids, nerve blocks, physical therapy and implanted neurostimulation devices, but Langford said relief is often inconsistent or short-lived. He added that the condition can begin during adolescence or early adulthood, potentially leaving patients to manage it for decades.
Rather than focusing solely on reducing pain signals, CY200 is designed as a neuroplastogenic therapy intended to address underlying neurobiology believed to drive and sustain CRPS, Langford said. The company’s goal is to improve both pain and functioning.
Morrison said the program’s next milestone is top-line data from a randomized Phase II trial evaluating CY200’s efficacy, safety and tolerability in participants with CRPS type one. The company said the new financing is intended to support that trial.
Existing Pipeline Remains in Development
Kirkpatrick said the acquisition and financing are not expected to come at the expense of Ensysce’s existing pipeline. The company plans to continue development of PF614 and PF614-MPAR, which it described as a new approach to opioid safety.
Ensysce said its updated corporate presentation, including further information on its combined strategy and pipeline, is available through the investor section of its website. The company did not take questions during the corporate update call.
About Ensysce Biosciences (NASDAQ:ENSC)
Ensysce Biosciences, Inc is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel prodrug therapies aimed at improving pain management and addressing opioid misuse. Leveraging its proprietary prodrug platform, the company designs drug candidates that convert into active pharmaceuticals through specific enzymatic action, providing controlled-release profiles and built-in abuse deterrence features.
The company’s lead product candidate, ENS100, is an investigational oral prodrug of hydrocodone engineered to reduce the potential for misuse and abuse compared to immediate-release opioid formulations.
