Zelira Therapeutics has secured a fourth funding tranche of US$681,000, advancing its HOPE® Autism Spectrum Disorder FDA trial process and bringing total funding to US$3.25 million. The company is progressing clinical validation and product development, including the transformation of Zenivol® into a capsule formulation.
- Fourth funding tranche of US$681,000 secured for HOPE® FDA trials
- Total HOPE® SPV funding now US$3.25 million
- FDA Phase 1 trial targeting irritability in Phelan McDermid Syndrome with ASD
- Zenivol® capsule formulation development on track for early 2025 completion
- Company cash position low; ongoing fundraising critical for operations
Funding Milestone for HOPE® Autism Program
Zelira Therapeutics Ltd (ASX:ZLD) has announced the receipt of a fourth funding tranche amounting to US$681,000 for its HOPE® Special Purpose Vehicle (SPV), dedicated to advancing FDA clinical trials for its proprietary HOPE® 1 product. This latest tranche brings the total funding secured through the SPV to US$3.25 million, a significant step in the company’s strategy to validate and commercialise cannabinoid-based medicines targeting Autism Spectrum Disorder (ASD).
The funding is managed via the HOPE® SPV, which Zelira controls with a 55% equity stake, while external investors contribute capital to support the clinical trial phases. The company’s CEO, Dr Oludare Odumosu, highlighted that this tranche follows constructive feedback from the FDA during a pre-IND meeting in July 2024, which helped refine the Phase 1 study design focusing on irritability symptoms in patients with Phelan McDermid Syndrome (PMS) comorbid with ASD.
Clinical Progress and Strategic Focus
The FDA Phase 1 trial represents a pivotal milestone for Zelira’s HOPE® program, marking the transition from special access scheme data to formal clinical validation. The company has appointed INGENŪ CRO Pty Ltd as the contract research organisation to lead the clinical trial process, with the target product profile already completed. This trial is expected to lay the groundwork for subsequent phases and regulatory submissions.
Alongside HOPE®, Zelira is advancing the development of Zenivol®, a cannabinoid-based treatment for chronic insomnia. The transformation of Zenivol® into Zelira’s proprietary Zyraydi™ capsule formulation remains on track for completion in early 2025, leveraging the company’s Enhanced Distillate Capture and Dissolution Matrix (EDCDM) technology. This innovation addresses pharmaceutical-grade solid oral dosage challenges, potentially broadening commercial opportunities.
Financial Position and Outlook
Despite the successful funding tranche, Zelira’s cash position at the end of December 2024 was critically low at A$38,000, with net operating cash outflows of A$1.077 million for the quarter. The company holds unused financing facilities of approximately A$1.1 million, providing just over one quarter of runway at current burn rates. Management confirms ongoing fundraising efforts to close the remaining US$32 million capital raise for the HOPE® 1 trials, which will be essential to sustain operations and meet clinical milestones.
Operational expenses reflect increased clinical trial spending, with research and development costs rising to A$292,000 in Q2 FY2025. Staff and administrative costs decreased due to timing of payments, but the overall cash burn underscores the importance of successful capital raises ahead.
Broader Pipeline and Market Potential
Beyond HOPE® and Zenivol®, Zelira is evaluating the progression of its diabetic nerve pain drug candidate ZLT-L-007 into formal FDA trials, following positive top-line results that showed superior efficacy to the pharmaceutical standard Lyrica®. The company’s portfolio also includes revenue-generating proprietary cannabinoid medicines marketed in Australia and select US states, alongside over-the-counter products in oral care and dermatology sectors.
Zelira’s strategic focus on clinical validation and regulatory approval aims to position it as a leader in cannabinoid-based prescription medicines globally. The successful advancement of the HOPE® program through FDA trials will be a critical inflection point, potentially unlocking significant market opportunities in neurodevelopmental disorders with unmet medical needs.
Bottom Line?
Zelira’s latest funding tranche propels its HOPE® autism trials forward, but sustained capital raises remain vital to navigate the costly path ahead.
Questions in the middle?
- Will Zelira secure the remaining US$32 million needed to complete HOPE® FDA trials?
- How will the FDA Phase 1 trial results impact investor confidence and share price?
- What commercial partnerships might Zelira pursue to accelerate Zenivol® capsule rollout?