Canurta Submits Pre-IND & Orphan Drug Applications, Advances AI Drug Development & Launches WSU Research

Canurta Therapeutics Secures Import License for Brazil

We are pleased to announce that Canurta Therapeutics, in collaboration with a recognized manufacturer and distributor of cannabis-based products—has received official authorization from ANVISA, Brazil’s National Health Surveillance Agency, to import our Novel Spectrum hemp extract, into Brazil.

This authorization enables:

• Patient-specific access to cannabis-based therapeutics for medical use under physician supervision

• Importation of prescribed quantities through 2026, supporting long-term treatment continuity

• Reinforcement of the regulatory framework for therapeutic cannabis access in Brazil’s evolving healthcare landscape

This milestone marks a pivotal step in expanding access to our novel therapeutics in one of Latin America's most dynamic healthcare markets. As part of our long-term growth strategy, we will continue to build strategic momentum in international markets.

U.S. Food and Drug Administration (FDA) Provides Written Feedback on Type B Pre-IND Submission

On March 1, 2025, Canurta Therapeutics received formal written feedback from the U.S. Food and Drug Administration (FDA) in response to our Type B Pre-Investigational New Drug (Pre-IND) submission. This regulatory milestone is significant in advancing CNR-401 for treating Amyotrophic Lateral Sclerosis (ALS).

The FDA’s feedback provides helpful clarification on our preclinical data requirements, proposed clinical trial design, and overall regulatory approach. Canurta’s clinical operations and R&D team are now incorporating and implementing the FDA’s recommendations into the CNR-401 drug development program and optimizing for future pipeline assets that will be presented to the FDA and other agencies around the world.

U.S. FDA Meeting Held in Response to Type C Pre-IND Submission

On March 25, 2025, Canurta held a Type C meeting with the FDA to discuss key regulatory considerations of the CMC development plan for CNR-401, including testing, manufacturing, and batch strategy.

The discussion was met with positive sentiment overall, reinforcing that our development strategy is aligned with regulatory expectations, while also providing helpful guidance to ensure full IND compliance. This reflects the emphasis we have placed on consistency, standardization, and scientific rigour throughout our program.

We are now integrating the FDA’s feedback to refine our approach and continue progressing toward clinical trials with confidence.

Update: Canurta Therapeutics Participates in First Canada-Chicago Mentoring Program (C2MP) Team Meeting

Canurta Therapeutics is pleased to share that we held our first team meeting with mentors from the Canada-Chicago Mentoring Program (C2MP) on March 19, 2025.

As one of only five Canadian companies selected for this highly competitive program, Canurta is honoured to collaborate with a distinguished mentor team whose combined expertise spans life sciences, legal strategy, and U.S. market development.

This mentorship engagement provides a valuable opportunity to refine our U.S. expansion strategy, strengthen positioning, and accelerate progress toward key milestones.

We look forward to a productive and high-impact partnership throughout the C2MP program.