Zelira Therapeutics Quarterly Report: Key Developments in HOPE® Program and New Funding
ZLD (ZLD) Share Update July 2024 Monday 29th
Zelira Therapeutics Advances HOPE® Program with New Funding and FDA Progress
Zelira Therapeutics Ltd (ASX:ZLD, OTCQB:ZLDAF), a global leader in cannabinoid-based medicines, has released its quarterly activities report for Q4 FY2024, highlighting significant progress in its HOPE® program and securing new funding to advance clinical trials.
Instant Summary:
- Receipt of US$681k from the third tranche of SPV funding.
- A$919k R&D Tax Incentive refund received.
- Patents secured for HOPE® 1 and HOPE® 2 in Australia and the US.
- Successful pre-IND meeting with the FDA for HOPE® 1.
- US$1.4 million unsecured loan received from the Company’s Chairman.
Funding and Financial Updates
In May, Zelira Therapeutics received the third tranche of funding totaling US$681k from the 2011 Forman Trust, bringing the total SPV funds to US$2.569 million out of a planned US$3.25 million. This funding is earmarked for FDA clinical trials of HOPE® 1.
Additionally, the company received an A$919k refund under the Australian Federal Government’s R&D Tax Incentive Scheme. These funds will support Zelira’s clinical development programs and business operations.
Post Quarter-End Achievements
In a significant milestone, Zelira secured patents for HOPE® 1 and HOPE® 2 formulations in both Australia and the US. This strengthens the company's position in developing treatments for Autism Spectrum Disorder (ASD).
In July, Zelira held a successful pre-Investigational New Drug (IND) meeting with the FDA for HOPE® 1. The FDA provided clear guidance on the study design for evaluating the safety and pharmacokinetics of the proposed doses of ZEL-HOP1, marking a significant step towards IND submission.
Additional Financial Support
Zelira received a US$1.4 million unsecured loan from the Company’s Chairman, Mr. Osagie Imasogie. The loan, on favorable terms, will support the advancement of the HOPE® SPV clinical trial and general working capital purposes. Subject to shareholder approval, the loan may convert to equity at a favorable conversion price.
Operational and Financial Performance
During Q4 FY2024, Zelira reported cash receipts from customers of $23k, driven mainly by sales of HOPE® in Australia. The company's net cash flow used in operations was $553k, with significant expenses in product manufacturing, research and development, and administrative costs.
Strategy and Outlook
Zelira remains focused on clinical validation and product development. The company is advancing FDA clinical trials for HOPE® 1 and evaluating further progression of its diabetic nerve drug treatment ZLT-L-007. Discussions with potential manufacturing partners for HOPE® 1 and Zenivol® are ongoing.
The receipt of additional funding and successful FDA interactions are positive developments for Zelira Therapeutics. These advancements are likely to boost investor confidence and positively impact the company's stock. Securing patents further strengthens Zelira's market position and potential for future revenue growth.
Investor Reaction:
Analysts are likely to react positively to the news of additional funding and successful FDA meetings. The secured patents and progress towards IND submission for HOPE® 1 are seen as significant milestones that could drive future growth.
Conclusion:
Investors should keep an eye on Zelira Therapeutics as it progresses with its HOPE® program and other clinical developments. The company's strategic advancements and financial support position it well for future growth. Subscribe to our newsletter for regular updates on Zelira and other stock market news.