PharmAla to Supply MDMA for Clinical Trial in Exchange for Data License
Key Insights
PharmAla Biotech has reached an agreement in principle to supply its LaNeo™ MDMA to a research institution for use in a clinical trial.
In exchange for providing LaNeo™ MDMA, PharmAla will receive a full and perpetual license to the efficacy and safety data generated by the trial.
This agreement allows PharmAla to potentially gain valuable intellectual property and data related to MDMA's clinical applications.
PharmAla Biotech Holdings Inc. (search) has announced an agreement in principle to supply its LaNeo™ MDMA to a research institution for an upcoming clinical trial. In return, PharmAla will receive a full and perpetual license to the efficacy and safety data produced during the study.
Nicholas Kadysh, CEO of PharmAla Biotech, stated that this agreement represents a strategic opportunity to acquire valuable intellectual property related to their MDMA product. While PharmAla typically sells LaNeo™ MDMA on commercial terms, the company is open to offering discounts in exchange for data sharing agreements.
The company aims to finalize the license and data sharing agreement before the end of 2024. The identity of the trial's principal investigators and institution is currently being withheld until the agreement is fully executed.
Access to Drug Quality Information
PharmAla provides researchers with access to drug product quality information to facilitate clinical trial registrations and IRB approvals. The company is confident in its ability to provide rapid support for converting clinical trial registrations to the LaNeo™ MDMA Chemistry, Manufacturing, and Control (CMC) package.
Share Issuance for Debt Settlement
PharmAla also announced the settlement of $100,000 of debt with an arm's length creditor through the issuance of 459,770 common shares at a price of $0.2175 per share.
About PharmAla Biotech
PharmAla Biotech Holdings Inc. (search) is focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. The company aims to alleviate the global backlog of clinical-grade MDMA for clinical trials and commercial sales in selected jurisdictions and develop novel drugs in the same class. PharmAla is currently provisioning clinical-grade MDMA for patient treatments outside of clinical trials. The company's research and development unit has completed proof-of-concept research into several IP families, including ALA-002, its lead drug candidate.