Slide 1: Efficacy of Zelira's Medicinal Cannabis Formulation for Treating Chronic Insomnia
For personal use only EFFICACY OF ZELIRA’S MEDICINAL CANNABIS FORMULATION FOR TREATING CHRONIC INSOMNIA FINAL REPORT FOR PHASE 1A/2B CLINICAL TRIAL ASX: ZLD OTCQB: ZLDAF WWW.ZELIRATX.COM
Slide 2: Disclaimer & Important Notice
DISCLAIMER & IMPORTANT NOTICE Disclaimer For personal use only This presentation has been prepared by Zelda Therapeutics Ltd ACN 103 782 378 (“Company”). It does not purport to contain all the information that a prospective investor may require in connection with any potential investment in the Comp
Slide 3: Key Insomnia Stats - USA Market
KEY INSOMNIA STATS-USA MARKET Insomnia is the most common sleep disorder in America For personal use only 30% 83% Of people who suffer from depression also experience symptoms of insomnia. Adults have ~60m symptoms of Affected by insomnia Nearly 50% insomnia Of adults > 60 suffer from symptoms of in
Slide 4: Unmet Need
UNMET NEED For personal use only Short Term Side-Effects of Approved Insomnia Medications • ‘Next Day’ effects: groggy, dizzy, tired, headaches, constipation and dry mouth Long Terms Side-Effects of Approved Insomnia Medications • Dependence and Tolerance • Withdrawal symptoms • Rebound insomnia • I
Slide 5: Zelira: Insomnia Phase 1a/2b Trial
ZELIRA: INSOMNIA PHASE 1A/2B TRIAL For personal use only A Study to Evaluate the Efficacy of Sublingual Cannabinoid Based Medicine Extract (ZTL-101) Compared with Placebo for the Treatment of Sleep Disorders Due to Insomnia Investigational Team: PI - Prof Peter Eastwood, Clinical Prof David Hillman,
Slide 6: Zelira: Insomnia Phase 1a/2b Trial Design
ZELIRA: INSOMNIA PHASE 1A/2B TRIAL DESIGN For personal use only Inclusion criteria: Exclusion criteria: •Chronic insomnia • Sleep apnea (self-reported difficulty initiating • Severe depression, and/or maintaining sleep on anxiety or stress three or more nights per week for at least 3 months) •ISI sc
Slide 7: Patient Comments
PATIENT COMMENTS * For personal use only Person Placebo ZTL-101 “Fell asleep and did not wake up in middle “Has zero effect on any insomnia.” of night…more than in past 22 years.” “Even with double doses for this “I haven't slept this well in a very long arm, still not sleeping.” time.” “Stayed awak
Slide 8: Met Primary and Secondary Endpoints
ZTL-101 MET PRIMARY AND SECONDARY ENDPOINTS Primary Endpoints Secondary Endpoints For personal use only Improved Objective and Subjective SAFE Measures of Insomnia • No serious adverse events Statistically significant improvement in: • Adverse events mild and transient • Time spent asleep • Maximal
Slide 9: Improves Insomnia Severity Index (ISI) Scores
ZTL-101 IMPROVES INSOMNIA SEVERITY INDEX (ISI) SCORES For personal use only 20 Moderate severity ISI Classifications for clinical insomnia 18 16 18.0 * 14 14.8 ** Sub clinical 12 mean ISI score 10 11.1 8 6 No insomnia 4 2 0 Placebo Low dose High dose (n=23) (n=11) (n=12) • ISI scores significantly i
Slide 10: Improved Objective Measures of Sleep (Actigraphy)
ZTL-101 IMPROVED OBJECTIVE MEASURES OF SLEEP (ACTIGRAPHY) For personal use only ZLT-101 vs Total Sleep Time Sleep Efficiency Wake After Sleep Onset Sleep Onset Latency Placebo (min) (%) (min) (min) Low dose ↑28* ↑2.61* ↓9.52 ↓0.25 (n=11) High dose ↑42** ↑3.57** ↓12.31* ↓1.19* (n=12) Average ↑33** ↑2
Slide 11: Improved Subjective Measures of Sleep (Patient Sleep Diaries)
ZTL-101 IMPROVED SUBJECTIVE MEASURES OF SLEEP (PATIENT SLEEP DIARIES) For personal use only ZLT-101 vs Total Sleep Time Quality of Sleep Rested on Waking Sleep Onset Latency Placebo (min) (score) (score) (min) Low dose ↑60* ↑0.53* ↑0.26 ↓10.2 (n=11) High dose ↑77** ↑0.98** ↑0.75** ↓10.5 (n=12) Avera
Slide 12: Improved People's Quality of Life Measured Using Subjective Questionnaires
ZTL-101 IMPROVED PEOPLE’S QUALITY OF LIFE MEASURED USING SUBJECTIVE QUESTIONNAIRES For personal use only Multidimensional Fatigue Inventory Work and Social Adjustment Scale Home ZLT-101 vs General Fatigue1 Mental Fatigue1 Total Fatigue1 Total WSAS2 Management2 Placebo Low dose ↓1.68* ↓2.0* ↓4.54 ↓0.
Slide 13: Comparable to Current Sleep Medications
ZTL-101 COMPARABLE TO CURRENT SLEEP MEDICATIONS For personal use only Criteria Temazepam Zolpidem Suvorexant Melatonin ZTL-101 (Temtabs®) (Stilnox®/Ambian®) (Belsomra®) Aspen Sanofi Merck Rapid Sleep Onset +/- ✓ ✓ X X Improved Sleep ✓ +/- X ✓ X Maintenance Increase Total Sleep ✓ ✓ ✓ ✓ X Improve ‘Qua
Slide 14: Summary for ZTL-101
SUMMARY FOR ZTL-101 For personal use only • First clinically validated medicinal cannabis drug targeting chronic insomnia • Phase 1b/2b clinical trial successfully achieved all primary and secondary endpoints • ZTL-101: safe and tolerable • ZLT-101 is efficacious: Patients slept longer, slept sooner
Slide 15: Next Steps: Launch, Learn & Develop
NEXT STEPS: LAUNCH, LEARN & DEVELOP For personal use only CHRONIC PAIN MENTAL DISORDERS (DEPRESSION/ ANXIETY) Global Markets 2020 INSOMNIA Launch, Learn… NEUROLOGICAL $ DISORDERS (PARKINSON'S) $$ CARDIOVASCULAR DISEASE ZTL-101 … & Develop CLINICAL Registration INSOMNIA DEVELOPMENT 15