HomeHealthcareZelira Therapeutics (ASX:ZLD)

Zelira’s R&D Refund Repayment Signals Funding Stability Amid Clinical Risks

Healthcare By Ada Torres 3 min read

Zelira Therapeutics has received a $1.07 million cash refund under Australia’s R&D Tax Incentive Scheme, reinforcing its funding for ongoing clinical trials and product development. The company has also repaid a prior loan advanced against this claim, positioning it for continued growth in cannabinoid-based medicines.

  • Received $1.07 million R&D tax refund from Australian government
  • Repaid $650,000 loan advanced against FY25 R&D claim, netting $374,000
  • Funds to support clinical trials, product development, and pipeline initiatives
  • Advancing HOPE® 1 clinical trials via a special purpose vehicle with $35 million funding
  • Expanding commercialization of cannabinoid medicines including ZENIVOL® in Germany

Zelira’s R&D Refund Strengthens Financial Position

Zelira Therapeutics Ltd (ASX – ZLD) has announced receipt of a $1.07 million cash refund under the Australian Federal Government’s Research and Development Tax Incentive Scheme. This refund follows the company’s earlier loan agreement with Rocking Horse Capital, where $650,000 was advanced against its FY25 R&D claim. The loan, along with associated fees and interest, has now been fully repaid, resulting in net proceeds of $374,000 for Zelira.

Funding Clinical and Product Development

The influx of funds will be directed towards Zelira’s ongoing clinical and product development programs. This includes advancing pipeline product initiatives and supporting essential business operations critical to maintaining momentum in their research and commercialization efforts. Zelira’s focus remains on clinically validated cannabinoid-based medicines targeting conditions such as insomnia, autism, and chronic non-cancer pain.

Progress on HOPE® 1 Clinical Trials

A key highlight for Zelira is its proprietary HOPE® 1 product, which is undergoing FDA Phase 1 to Phase 3 clinical trials through a special purpose vehicle (SPV). Zelira holds a 55% equity stake in this SPV, with cash investors contributing approximately US$35 million to fund the trials. The SPV has engaged iNGENū CRO Pty Ltd to manage clinical validation and regulatory submissions, including the Investigational New Drug application with the US FDA.

Expanding Market Reach and Product Portfolio

Beyond clinical trials, Zelira is actively commercializing its cannabinoid medicines. The company’s HOPE® formulations generate revenue in Australia and select US states, while ZENIVOL®, the world’s first clinically validated cannabinoid drug for chronic insomnia, is set to enter the German market through a partnership with Adjupharm GmbH. Additionally, Zelira’s over-the-counter products, including oral care and dermatology lines, continue to gain traction, particularly in the US market.

Innovative Technologies and Future Opportunities

Zelira is also developing proprietary technologies such as the Enhanced Distillate Capture and Dissolution Matrix (EDCDM) under the Zyraydi™ brand. This technology addresses challenges in pharmaceutical-grade cannabinoid formulations, potentially opening new avenues for solid oral dosage forms like capsules and tablets. The company is evaluating commercialization opportunities for this innovation, which could further diversify its product offerings.

Bottom Line?

Zelira’s latest R&D refund and loan repayment clear the way for sustained clinical progress and market expansion in cannabinoid therapeutics.

Questions in the middle?

  • When will key clinical trial results for HOPE® 1 be announced, and how might they impact regulatory approvals?
  • What is the expected commercial impact of ZENIVOL®’s launch in Germany on Zelira’s revenue streams?
  • How will Zelira leverage its proprietary Zyraydi™ technology to differentiate its product pipeline?