Zelira Therapeutics (ASX: ZLD) has secured US$32.98 million in new funding after its HOPE 1 special purpose vehicle (SPV) signed definitive agreements with US-based life sciences investor ThirdGate Capital's TGC Biotechnology Fund.
The fundraising values the HOPE 1 SPV at US$65.96m and provides sufficient capital to progress the program through an accelerated US regulatory pathway.
At completion, ThirdGate Capital will hold a 50% fully diluted interest in the SPV, with Zelira retaining a 39.7% stake following its contribution of intellectual property and real-world clinical data.
Zelira expects to close the transaction by the end of January and believes it represents a significant step in the company’s strategy to advance HOPE 1 through late-stage clinical development in the United States.
Funding of Clinical Development
Zelira has structured the SPV to allow external capital to fund clinical development in a way that strengthens its balance sheet while allowing HOPE 1 to be advanced independently under a dedicated development and governance structure.
Funds from the raise will be used to progress HOPE 1 under the US Food and Drug Administration’s 505(b)(2) regulatory pathway, which is designed to reduce development timelines by leveraging existing clinical and regulatory data.
Zelira has already completed a Pre-Investigational New Drug (IND) meeting with the FDA, which confirmed that the proposed clinical plan and initial target indication are appropriate for advancement.
The company said this regulatory clarity provides a defined pathway toward filing an IND application and initiating formal first-in-human clinical trials in the US.
Autism Spectrum Disorder Focus
HOPE 1 is being developed for the treatment of autism, with an initial focus on Phelan-McDermid Syndrome, a genetically defined and rare subset of autism spectrum disorder.
The FDA has confirmed that Phelan-McDermid Syndrome qualifies as a rare disease, positioning the program to seek Orphan Drug Designation and access associated regulatory incentives and potential data exclusivity.
Zelira chief executive officer Oludare Odumosu said the fundraising marked a pivotal milestone for the company and its lead clinical asset.
“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,” Dr Odumosu said.
The SPV is now focused on progressing regulatory submissions and initiating clinical trials as it moves HOPE 1 toward late-stage development and potential commercialisation.
