Emyria Ltd (ASX:EMD) has completed an oversubscribed $1.2 million placement to new strategic investors with the aim to accelerate the company’s drug development programs.
A total of 14.12 million new ordinary shares will be issued at 8.5 cents per share with a 1 for 3 free attaching unlisted option exercisable at 20 cents expiring two years from the date of issue.
The placement is cornerstoned by the lead manager Sixty Two Capital, which contributed $500,000 of the $1.2 million raised.
“Accelerating drug development”
The investment increases the company’s cash position to around $5 million.
Emyria managing director Dr Michael Winlo said: “We’re very pleased with the significant interest we received in this placement, largely supported by new shareholders who share our vision for the unique opportunities ahead as we launch independent drug development programs backed by deep analysis and discoveries made from within our own real-world evidence and clinical data.
“It is pleasing to see this vision shared by our new shareholders who have a long-term view of Emyria’s value proposition.
“We now have a strengthened register, wider representation and a strong balance sheet which will help accelerate our first two, data-backed drug development programs focussed on obtaining TGA registration.”
Schedule 3 decision
Emyria’s drug development programs are set to benefit from the final decision from the TGA to allow low dose CBD to become a Schedule 3 medicine on the Australian Register of Therapeutic Goods (ARTG).
The TGA made its final ruling on Tuesday, December 15, 2020, and clarified that ‘applications to register a Schedule 3 low-dose CBD preparation on the ARTG would involve assessment of safety and efficacy data to support the proposed dose and indication’.
This decision could allow patients to purchase formally registered low-dose CBD products as Pharmacist Only medications, for specific indications.
Higher doses of CBD and other cannabinoid medicines would still require a prescription from a medical practitioner.
The company’s first two independent drug programs - EMD-003 (mental health) and EMD-004 (irritable bowel syndrome) - target widespread unmet needs and are targeting registration with the TGA.
Emyria data clinical evidence
As per the final decision, all applications to register a Schedule 3 low dose CBD preparation on the ARTG require supporting clinical evidence of safety and efficacy to support a proposed dose and indication.
Emyria Data covers patient demographics, clinical diagnoses, concomitant medications, adverse event monitoring, vital signs, validated clinical assessments, patient-reported outcomes and more.
Dr Winlo said: “Regulators play an important role ensuring medicines are safe and effective before they are available to patients which is why they require high-quality clinical evidence for all new product registrations.
“Since founding, Emyria has carefully gathered and curated one of the largest and most comprehensive, ethically sourced, clinical data sets covering a wide range of CBD doses, clinical indications, validated clinical changes and safety data.
“This data is a source of unique insights and IP and strategically informs Emyria’s own drug development programs.”
“Funds support clinical trials”
The placement funds will support the acceleration of pivotal clinical trials required as an important first step towards the registration of EMD-003 and EMD-004 with the TGA as Scheduled medicines.
Dr Winlo said: “The company is currently well-funded to achieve registration milestones related to our first two drug development programs addressing major unmet needs EMD-003, focused on mental health and EMD-004, focused on irritable bowel syndrome (IBS).
“The TGA decision supports our strategy to pursue high quality, data-backed registration for our products.”
“Potential for tremendous growth”
Sixty Two Capital director Sufian Ahmad said “Sixty Two Capital takes pride in generating value for its clients through investments in companies it believes has the potential to achieve tremendous growth.
“We believe that Emyria’s real-world data assets are key to establishing multiple cannabinoid drug registrations with major regulatory bodies, which very few other companies have been able to accomplish to date.”