Zelira’s HOPE® 1 Faces Clinical Trial Risks Despite Major US$33M Fundraise
Zelira Therapeutics has raised nearly US$33 million from ThirdGate Capital to advance its HOPE® 1 drug targeting autism-related Phelan-McDermid Syndrome through FDA clinical trials. This funding milestone sets the stage for pivotal regulatory progress in the US.
- US$32.98 million raised into HOPE® 1 SPV with ThirdGate Capital acquiring 50% stake
- SPV valued at approximately US$66 million post-money
- Funding to support FDA IND submission and Phase 1 clinical trial initiation
- Focus on rare disease Phelan-McDermid Syndrome with autism comorbidity
- Orphan Drug Designation pursuit to unlock regulatory and commercial benefits
A Transformative Capital Injection
Zelira Therapeutics Ltd (ASX, ZLD) has announced a significant fundraising round, securing US$32.98 million from ThirdGate Capital to fuel the clinical development of its HOPE® 1 drug candidate. This infusion of capital into the HOPE® 1 Special Purpose Vehicle (SPV) values the entity at nearly US$66 million post-money and marks a pivotal step in Zelira’s ambition to bring a novel cannabis-based treatment for autism spectrum disorders to the US market.
Targeting a Rare and Underserved Condition
The HOPE® 1 program is focused on Phelan-McDermid Syndrome (PMS), a rare genetic disorder often accompanied by autism spectrum disorder (ASD). Following a successful Pre-IND meeting with the US Food and Drug Administration (FDA) in 2024, Zelira received confirmation that PMS qualifies as a rare disease, enabling the company to seek Orphan Drug Designation. This status offers valuable incentives including seven years of data exclusivity, which could significantly enhance the commercial potential of HOPE® 1.
Clear Regulatory Pathway and Clinical Progress
The capital raised will fund the submission of an Investigational New Drug (IND) application and the initiation of Phase 1 clinical trials, marking the first formal dosing of HOPE® 1 under FDA oversight. The SPV has appointed iNGENū CRO to manage the clinical trial process, underscoring a structured and efficient approach to regulatory compliance. Zelira’s leadership, including Executive Chairman Osagie Imasogie, emphasises a laser focus on progressing the FDA clinical program swiftly and effectively.
Strategic Partnership with ThirdGate Capital
ThirdGate Capital’s investment, representing a 50% equity stake in the SPV, is a strong endorsement of Zelira’s science and vision. Senior Partner Cynthia Parrish highlighted the compelling real-world patient data and the clear regulatory pathway as key factors in their decision to back the project. This partnership not only brings substantial funding but also strategic oversight, with ThirdGate appointing three board members to the SPV alongside Zelira’s two directors.
Broader Implications for Zelira’s Pipeline
Beyond HOPE® 1, Zelira continues to build momentum with its portfolio of cannabinoid-based medicines, including products for insomnia and chronic pain, as well as over-the-counter offerings. The company’s innovative drug delivery technology, Zyraydi™, and ongoing commercial expansion into markets such as Germany, position Zelira as a notable player in the biopharmaceutical cannabis space. The successful advancement of HOPE® 1 through FDA trials could serve as a catalyst for further growth and validation of Zelira’s broader pipeline.
Bottom Line?
With US$33 million secured and a clear FDA pathway, Zelira is poised to redefine autism treatment; next comes the critical clinical trial milestones.
Questions in the middle?
- When will the FDA IND submission and Phase 1 trial initiation officially occur?
- How might the pursuit of Orphan Drug Designation impact Zelira’s commercial strategy?
- What are the potential risks if clinical trial outcomes do not meet expectations?
