Zelira Therapeutics (ASX:ZLD) has secured US$33 million (before costs) through a strategic fundraising with TGC Biotechnology Fund, into its HOPE 1 special purpose vehicle, bringing total equity raised to US$36.6 million.
The fundraising values Zelira’s 39.7% interest in the SPV at US$26.2 million.
Zelira CEO Dr Oludare Odumosu described the funding as "a compelling endorsement of our vision, science, and the potential of HOPE 1," which targets Phelan-McDermid Syndrome and other forms of autism.
The SPV is now capitalised to advance an accelerated regulatory strategy through the US FDA 505(b)(2) pathway, positioning HOPE 1 to pursue Orphan Drug Designation with associated data exclusivity and incentives.
The HOPE 1 program recently achieved a successful Pre-IND meeting with the FDA, confirming PMS as an appropriate rare disease target and endorsing Zelira’s plans for a first-in-human clinical trial.