Zelira Therapeutics ASX:ZLD Stock Report

Zelira's Zenivol™, the First Clinically Validated Cannabinoid Medication for Insomnia, Achieves Regulatory Approval in Germany

Zelira Therapeutics Ltd. announced that its insomnia medication Zenivol™ has achieved formal approval from German regulatory authority BfArM to launch in the German medical cannabis market. Zenivol™ is the first and only clinically validated, pharmaceutical-grade, cannabis-based sleep medication. Zenivol™'s clinical research achieved the higher level of scientific review when it was peer reviewed in the Journal of Sleep. It is currently available by prescription in Australia under the country's legal cannabis regulations.

Zelira Therapeutics Ltd Publishes White Paper Detailing the Analysis of Longitudinal, Real-World Data Generated from Patients Using ZENIVOL

Zelira Therapeutics Ltd. announced that it has published a white paper detailing the analysis of longitudinal, real-world data (RWD) generated from patients using ZENIVOL®. The agreement between Zelira Therapeutics and Emyria Ltd. (ASX:EMD) was to collect longitudinal, real world data for patients diagnosed with chronic insomnia who were treated with Zelira's ZENIVOL® product including de-identified patient data relating to diagnosis and co-morbidities, concomitant medications, dosages prescribed to patients and the ef ectiveness of ZENIVOL® using various clinical and subjective endpoints including the Insomnia Severity Index (ISI) questionnaire. The longitudinal, real-world data (RWD) of 94 patients was generated from two data sources: Dispensing data obtained as part of Zelira's regulatory obligations and Zelira sponsored observational trial conducted by Emyria's Emerald Clinics (n = 42). The results published in a white paper are available on Zelira's website her e. A summary of the key findings include: Mean age of patients on ZENIVOL® was 54 years of age; the youngest and oldest patient were 6 and 78 years of age respectively. A substantial proportion of active ZENIVOL® patients were over the age of 65 suggesting that in the short to medium term, ZENIVOL® is safe and ef ective in this cohort. Mean time on ZENIVOL® was 4.3 months; maximum treatment time to-date was 10.8 months. The primary indications of patients receiving ZENIVOL® was Chronic non-cancer pain (44%), Insomnia (36%) and post-traumatic stress disorder (12%). The Emerald Clinics ZENIVOL® patients, most reported being on a concomitant medication for pain relief ranging from opioids (i.e., oxycodone, codeine, tramadol), to benzodiazepines (diazepam) to over-the-counter pain relief medications (i.e., paracetamol, ibuprofen). ZENIVOL® appears to be ef ective: Overall, patients had a mean baseline ISI score of 19.5 (Moderate clinical insomnia), however after taking ZENIVOL® the mean ISI score significantly reduced to 14.3 (Subthreshold insomnia levels) (p<0.001). At baseline, 15 patients were rated as having Severe clinical insomnia. After being on ZENIVOL®, 33% of these patients had reduced their ISI score to Moderate clinical insomnia levels, and 40% had reduced to Subthreshold insomnia levels. No improvement in the ISI score was seen in 27% of the Severe clinical insomnia patients. At baseline, nine (9) patients were rated as having Moderate clinical insomnia. After being on ZENIVOL®, a third saw no improvement in their insomnia, whilst 44% reduced their ISI score to Subthreshold insomnia levels and 22% achieved ISI scores that rated them as having No clinically significant insomnia. For those patients with Subthreshold insomnia at baseline, 20% were able to reduce their ISI scores to No clinically significant insomnia, with the remainder maintaining a Subthreshold insomnia rating.

Zelira Therapeutics Ltd Announces Resignation of Harry Karelis as Non-Executive Vice Chairman

Zelira Therapeutics Ltd. announced that Mr. Harry Karelis has resigned from the position of Non-Executive Vice Chairman effective 12 May 2022.

Zelira Therapeutics Limited Successfully Launches ITURA with CVSCM