Zelira Therapeutics Ltd (ASX:ZLD, OTCQB:ZLDAF) has secured a major funding milestone after its HOPE® 1 special purpose vehicle (SPV) signed definitive agreements to raise US$32.98 million (AU$49.21m), strengthening the company’s balance sheet and accelerating its lead autism drug candidate toward US FDA approval.
The fundraising values the HOPE® 1 SPV at a post-money valuation of US$65.96 million and assigns Zelira’s retained interest in the vehicle a post-money value of US$26.19 million, underlining growing institutional confidence in the program’s clinical and regulatory pathway.
ThirdGate Capital emerges as cornerstone investor
Under the transaction, TGC Biotechnology Fund, P.S. (ThirdGate Capital) will hold a 50.00% fully diluted interest in the HOPE® 1 SPV at close. Zelira will retain a 39.70% interest, with existing investors holding 5.42% and a management incentive pool accounting for 4.88%.
The capital raise brings total equity issued by the SPV to US$36.56 million and provides funding to execute a comprehensive FDA development program, including Phase 1/2 and Phase 3 clinical trials.
Zelira said the funding represents a significant step forward for HOPE® 1, a proprietary cannabinoid-based medicine being developed for autism spectrum disorder, beginning with the rare genetic condition Phelan-McDermid Syndrome.
CEO highlights endorsement of science and strategy
Zelira CEO Dr Oludare Odumosu said the transaction validated both the company’s scientific approach and its regulatory strategy.
“This transformative Fundraising directly into the HOPE® 1 SPV represents a compelling endorsement of our vision, our science, and the significant potential of HOPE® 1. We welcome ThirdGate Capital as our partner and its recognition of what we have always believed: that HOPE® 1 stands to revolutionise the treatment landscape for individuals living with autism, including rare and underserved forms, starting with Phelan-McDermid Syndrome.
"The fundraising provides the SPV with sufficient capital to complete its accelerated regulatory pathway strategy utilising the United States’ FDA 505(b)(2) pathway.
"We are energised by the path forward and remain committed to delivering real solutions for autism patients, families and physicians/healthcare professionals who treat autism, while ensuring value for our shareholders.”
Funding aligned with accelerated FDA pathway
The HOPE® 1 SPV plans to deploy the capital toward a staged FDA program, with US$17.69 million allocated to Phase 1/2 clinical trials and US$14.07 million earmarked for Phase 3 studies. All trials will be conducted exclusively with iNGENū CRO.
Zelira has already completed a Pre-IND meeting with the US FDA, which confirmed that the initial target indication—Phelan-McDermid Syndrome with comorbid autism—is appropriate for the proposed clinical plan. The FDA also agreed that Phelan-McDermid Syndrome qualifies as a rare disease, positioning the program to seek Orphan Drug Designation.
If granted, Orphan Drug status would provide regulatory incentives and seven years of data exclusivity, running concurrently with HOPE® 1’s patent protection.
ThirdGate cites confidence in regulatory clarity and data
ThirdGate Capital senior partner Cynthia Parrish said the investment was underpinned by strong clinical and regulatory fundamentals.
“We are excited to partner with Zelira on this transformative journey to bring HOPE® 1 through the FDA approval process. The compelling real-world patient data, combined with the clear regulatory pathway established through the Pre-IND meeting, gives us confidence in HOPE® 1’s potential to address a significant unmet need for patients with Phelan-McDermid Syndrome and autism spectrum disorder.”
Next steps: IND submission and first-in-human dosing
With funding secured, the SPV is now focused on submitting an Investigational New Drug application to the FDA, initiating its Phase 1 clinical trial and filing for Orphan Drug Designation.
Zelira chairman Osagie Imasogie, who has been appointed executive chairman of the SPV, said the funding marked a critical inflection point for the program.
“I am thrilled to build on our relationship with the ThirdGate Capital Team to get HOPE® through the FDA process in the most efficient and expeditious manner. We are grateful for ThirdGate Capital’s funding and investment and that of The 2011 Forman Investment Trust and Mr. Malik Majeed, who were our first institutional/Family Office investors into the SPV. Their initial funding was crucial in getting the SPV to the inflection point at which we were able to attract ThirdGate Capital’s interest and transformative funding investment. With this funding secured, we are now laser focused on progressing our HOPE® FDA clinical program.”
SPV structure preserves long-term value
Zelira established the HOPE® 1 SPV in 2023 to fund US clinical development and commercialisation while retaining significant equity exposure. The company has contributed intellectual property and real-world data in exchange for its 39.70% stake, and Zelira and ThirdGate have confirmed there is no current intention to spin out or list the SPV.
The transaction positions Zelira to advance HOPE® 1 through a clearly defined FDA pathway while maintaining meaningful upside for shareholders as the program progresses.