Zelira Raises $681K Fourth Tranche, Totaling $3.25M for FDA Clinical Trials
Zelira Therapeutics has received a fourth funding tranche, bringing total investment to US$3.25 million to support FDA clinical trials of its HOPE® 1 cannabinoid medicine targeting irritability in autism spectrum disorder and Phelan-McDermid Syndrome.
- Fourth funding tranche of US$681,000 received from 2011 Forman Trust
- Total SPV funding for HOPE® 1 FDA trials now US$3.25 million
- Positive FDA feedback on Phase 1 trial design targeting irritability in PMS with ASD
- Zelira manages SPV and plans further fundraising rounds
- HOPE® 1 is a proprietary, patent-protected cannabinoid medicine
Funding Milestone for HOPE® 1 Clinical Program
Zelira Therapeutics (ASX:ZLD) has announced the receipt of the fourth tranche of funding amounting to US$681,000 from the 2011 Forman Trust, bringing the total capital raised through its special purpose vehicle (SPV) to US$3.25 million. This funding is earmarked to support the clinical development of Zelira's proprietary HOPE® 1 product, a cannabinoid-based medicine undergoing FDA-regulated trials.
The SPV structure, managed by Zelira, is designed to facilitate the progression of HOPE® 1 through Phase 1, 2, and 3 clinical trials in the United States. Zelira holds a majority 55% equity stake in the SPV, with cash investors contributing the remainder, targeting a total funding pool of approximately US$35 million to complete the FDA trial program.
FDA Engagement and Clinical Trial Design
In July 2024, Zelira engaged in a Pre-IND meeting with the U.S. Food and Drug Administration, receiving constructive feedback that has helped shape the design of the upcoming Phase 1 study. The FDA's guidance confirmed support for the clinical program and clarified key parameters, including the target population and endpoints. The trial will focus on treating irritability symptoms in patients diagnosed with Phelan-McDermid Syndrome (PMS) who also have comorbid Autism Spectrum Disorder (ASD), a niche with significant unmet medical needs.
This regulatory endorsement represents a critical step toward submitting the Investigational New Drug (IND) application and initiating clinical trials, underscoring the potential of HOPE® 1 to address challenging neurodevelopmental conditions.
Strategic Positioning and Future Outlook
Zelira's broader portfolio includes revenue-generating proprietary cannabinoid medicines marketed in Australia and select U.S. states, alongside over-the-counter products and innovative pharmaceutical technologies like the Enhanced Distillate Capture and Dissolution Matrix (EDCDM) under the Zyraydi™ brand. The company is also expanding its commercial footprint in Europe with the launch of ZENIVOL®, a cannabinoid drug for chronic insomnia, in Germany.
With the HOPE® 1 FDA clinical program advancing, Zelira anticipates further fundraising rounds to fully capitalize on the development pathway. The company’s ability to secure ongoing investment will be pivotal in maintaining momentum toward regulatory approvals and eventual market entry.
As Zelira navigates this complex clinical and regulatory landscape, its progress will be closely watched by investors seeking exposure to the emerging cannabinoid pharmaceutical sector.
Bottom Line?
Zelira’s successful funding rounds and FDA collaboration set the stage for a potentially transformative clinical program in autism-related disorders.
Questions in the middle?
- What is the timeline for completing the Phase 1 trial and submitting the IND application?
- How will Zelira secure the remaining US$31.75 million needed to fully fund the SPV?
- What are the commercial prospects and market size for HOPE® 1 if FDA approval is achieved?