Zelira Therapeutics Secures US$33M Fundraising to Propel HOPE® 1 FDA Trials

Transformative Fundraising Boosts HOPE® 1 Development

Zelira Therapeutics (ASX:ZLD) has secured a significant capital injection of US$32.98 million into its HOPE® 1 special purpose vehicle (SPV), valuing the SPV at a post-money US$65.96 million. This fundraising round leaves Zelira with a 39.7% stake in the SPV, translating to a US$26.19 million interest. The injection is earmarked to accelerate the regulatory and clinical development of HOPE® 1, a proprietary cannabinoid-based medicine targeting autism spectrum disorder.

The funds will underpin key upcoming milestones, including the Investigational New Drug (IND) submission to the US FDA and the initiation of the Phase 1 clinical trial; the first formal dosing of HOPE® 1 in humans under the FDA process. Zelira’s Executive Chairman of the SPV, Osagie Imasogie, emphasised the company’s focus on efficiently navigating the FDA pathway to bring HOPE® 1 closer to market.

Fundraising Delay and Commitment to Close

Despite the size and strategic importance of the capital raise, the closing of the fundraising has been delayed due to complications outside the control of Zelira and its funding partner, ThirdGate Capital. Both parties remain committed to finalising the transaction and advancing the clinical program. The SPV will also use proceeds to pay licence fees for Zelira’s Zyraydi technology, which reformulates HOPE® 1 into a cost-effective capsule form, enhancing manufacturing competitiveness.

Operational Cash Flow and Director Loans

Operationally, Zelira reported a net cash outflow of $154,000 in Q4 FY2026, with a closing cash balance of $62,000. The quarter saw increased research and development expenses of $69,000, reflecting trial preparations, alongside steady staff and administrative costs. The company received $356,000 from an insurance claim related to inventory damage, which was subsequently written off.

To support ongoing operations, several directors have extended unsecured loans totaling approximately US$1.7 million, with some loans convertible into shares pending shareholder approval. These loans carry a 20% annual interest rate, paid monthly, highlighting the directors’ financial backing amid the company’s tight cash position.

Regulatory Status and ASX Suspension

Zelira remains suspended from ASX quotation since March 2026 for not lodging interim financial reports on time. The company intends to lodge its December 2025 interim financial statements shortly after the fundraising closes and will seek reinstatement of its securities to quotation. This suspension underscores the importance of the fundraising closure to restore market confidence and liquidity.

Broader Clinical Pipeline and Commercial Focus

Beyond HOPE® 1, Zelira is advancing its diabetic nerve pain drug ZLT-L-007, which recently demonstrated superior efficacy over Pfizer’s Lyrica® in an IRB-approved trial. The company is evaluating progression of ZLT-L-007 into formal FDA clinical trials, signalling a broader clinical validation strategy. Zelira’s commercial footprint includes cannabinoid medicines marketed in select US states and plans to launch ZENIVOL®, a cannabinoid insomnia drug, in Germany.

With clinical validation and product development at the core of its growth strategy, Zelira is positioning itself to capitalise on the expanding market for cannabinoid-based prescription medicines, leveraging its proprietary formulations and patent-protected technologies.