Zelira Raises US$33M, Values HOPE 1 SPV at US$66M Post-Money
Zelira Therapeutics has raised nearly US$33 million to fund clinical trials for its HOPE 1 cannabinoid-based medicine targeting autism, while also benefiting from a $1.07 million R&D tax refund.
- US$32.98 million raised for HOPE 1 SPV, valuing it at US$66 million post-money
- Zelira retains 39.7% equity in HOPE 1 SPV after fundraising
- FDA 505(b)(2) regulatory pathway targeted for accelerated approval
- Received $1.07 million Australian R&D tax incentive refund
- Operational cash flow positive at $529k for Q2 FY2026
Transformative Fundraising Boosts HOPE 1 Development
Zelira Therapeutics has announced a significant capital injection of nearly US$33 million into its HOPE 1 special purpose vehicle (SPV), marking a pivotal step in advancing its cannabinoid-based medicine aimed at autism treatment. This fundraising, led by ThirdGate Capital alongside other institutional investors, values the HOPE 1 SPV at approximately US$66 million post-money. Zelira retains a substantial 39.7% stake, underscoring its ongoing commitment to the project.
The funds will primarily support the accelerated regulatory pathway strategy through the US Food and Drug Administration’s (FDA) 505(b)(2) process, which allows for a streamlined approval leveraging existing data. This approach aims to bring HOPE 1 to market faster, addressing a critical need for autism therapies.
Operational Progress and Financial Health
Alongside the fundraising, Zelira reported positive operational cash flow of $529,000 for the quarter ending December 2025, reflecting disciplined cost management amid clinical trial preparations. The company also received a $1.07 million cash refund under the Australian Federal Government’s Research and Development Tax Incentive Scheme, providing additional financial support for its innovation efforts.
Despite a modest cash balance of $52,000 at quarter end, Zelira has repaid prior R&D loan facilities and secured director loans totaling US$150,000 on attractive terms, indicating confidence from its leadership in the company’s trajectory.
Clinical and Commercial Outlook
The immediate focus for the HOPE 1 SPV is submitting an Investigational New Drug (IND) application to the FDA, followed by initiating Phase 1 clinical trials, the first formal dosing of HOPE 1 in humans under FDA oversight. The company is also pursuing Orphan Drug Designation to leverage regulatory and commercial incentives linked to rare diseases.
Beyond HOPE 1, Zelira is advancing other pipeline candidates, including ZLT-L-007 for diabetic nerve pain, which recently demonstrated promising results outperforming existing treatments in clinical studies. The company’s commercial footprint extends internationally, with products generating revenue in US states and plans to launch the world’s first clinically validated cannabinoid drug for chronic insomnia in Germany.
Leadership and Strategic Partnerships
Zelira’s Chairman, Osagie Imasogie, now Executive Chairman of the HOPE 1 SPV, highlighted the importance of the partnership with ThirdGate Capital in securing transformative funding. CEO Dr Oludare Odumosu emphasised the company’s dedication to delivering meaningful solutions for autism patients and healthcare providers, while ensuring shareholder value.
With a robust clinical validation strategy and a growing portfolio of proprietary cannabinoid medicines, Zelira is positioning itself as a global leader in this emerging pharmaceutical sector.
Bottom Line?
Zelira’s substantial fundraising and regulatory progress set the stage for critical FDA milestones that could redefine autism treatment options.
Questions in the middle?
- How will the upcoming FDA Phase 1 trial results impact Zelira’s valuation and investor confidence?
- What are the timelines and likelihood of securing Orphan Drug Designation for HOPE 1?
- How will Zelira manage liquidity given the low cash balance despite recent fundraising?
