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.
The SPV will now focus on filing an IND, initiating Phase 1 trials, and pursuing Orphan Drug status.
Zelira's Executive Chairman of the SPV, Osagie Imasogie, highlighted the role of ThirdGate Capital and earlier investors, noting their contributions were crucial in reaching this "inflection point" and enabling the next phase of the HOPE FDA clinical program.
The SPV, managed by Zelira, will conduct Phase 1–3 trials with iNGENū CRO.
At the time of reporting, Zelira Therapeutics’ share price was $0.85.