Zelira Therapeutics (ASX:ZLD) has taken a significant step forward in its mission to deliver clinically validated cannabinoid-based medicines, announcing a US$32.98 million capital raise into its HOPE 1 special purpose vehicle (SPV).
The fundraising, completed through definitive agreements with TGC Biotechnology Fund, P.S. (ThirdGate Capital), positions the HOPE 1 program for accelerated progress through the United States regulatory pathway and underscores growing confidence in its potential to address unmet needs in autism spectrum disorder.
At close, ThirdGate Capital will hold a 50 per cent fully diluted interest in the HOPE 1 SPV, with Zelira retaining a substantial 39.7 per cent stake. Existing investors and a management incentive pool account for the balance.
The transaction values the SPV at approximately US$66 million and places Zelira’s post-money interest at more than US$26.1 million. In total, the SPV has now issued US$36.6 million in equity, providing the financial foundation required to advance clinical development.
Zelira’s Managing Director and Chief Executive Officer, Dr Oludare Odumosu, described the fundraising as a strong endorsement of both the company’s scientific approach and the promise of HOPE 1. He noted that the investment validates Zelira’s long-held belief that HOPE 1 could reshape the treatment landscape for individuals living with autism, particularly rare and underserved populations. The initial focus will be on Phelan-McDermid Syndrome, a genetically defined and rare condition that falls within the autism spectrum.
The newly secured capital enables the HOPE 1 SPV to pursue an accelerated regulatory strategy in the United States using the FDA’s 505(b)(2) pathway. This approach is designed to streamline development timelines while maintaining rigorous regulatory standards.
In 2024, Zelira successfully completed a Pre-IND meeting with the U.S. Food and Drug Administration, during which the agency confirmed that Phelan-McDermid Syndrome with comorbid autism is an appropriate initial target indication. The FDA also agreed that the condition qualifies as a rare disease, opening the door for Orphan Drug Designation and its associated incentives, including seven years of data exclusivity.
ThirdGate Capital echoed this confidence in the program’s prospects. Senior Partner Cynthia Parrish highlighted the strength of the real-world patient data generated to date and the clarity the FDA has provided on the regulatory pathway. She emphasised that these factors support HOPE 1’s potential to address a significant unmet need for patients with Phelan-McDermid Syndrome and broader autism spectrum disorder.
Zelira’s Chairman, Osagie Imasogie, who has been appointed Executive Chairman of the SPV, noted that the investment builds on early support from institutional and family office investors whose initial funding was instrumental in reaching this inflection point. He said the company is now firmly focused on advancing the HOPE 1 clinical program through the FDA process in the most effective and expeditious manner possible.
Established in 2023, the HOPE 1 SPV was created to finance U.S. clinical trials and the commercialisation of HOPE 1. Zelira has contributed intellectual property and real-world clinical data in exchange for its equity stake, while cash investors have provided the capital required to fund development. The company added that there is currently no intention to spin out or list the SPV separately.