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Cannabinoid Therapeutics
Pharmaceutical CBD and Proprietary Cannabinoids for the Treatment of Serious and Life-Threatening Disease TSXV: KALY | August 2018
Disclaimers
Forward-Looking Statements: This investor presentation contains forward-looking statements. Forward-looking statements provide Kalytera’s current expectations or forecasts of future events. You can identify these statements by the fact that they do not relate strictly to historical or current facts. You can find many (but not all) of these statements by looking for words such as “approximates,” “believes,” “hopes,” “expects,” “anticipates,” “estimates,” “projects,” “intends,” “plans,” “would,” “should,” “could,” “may,” “will” or other similar expressions. In particular, these include statements relating to future actions; Kalytera’s prospective products, applications and customers; and information about future performance or results of prospective products. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from Kalytera’s historical experience and its present expectations or projections. Factors that could cause actual results to differ from those discussed in the forward-looking statements include, but are not limited to, whether:
— the results of research conducted on animals may be reflected in human trials; — Kalytera can ultimately develop products for use by humans; — products developed by Kalytera will receive approval by appropriate governing agencies for marketing; — demand can be created for the products Kalytera develops; — Kalytera’s products will be adversely affected by competitive or alternative products, technologies and pricing; — Kalytera will have the ability, assuming it receives approval to market its products, to manufacture or have manufactured any products it develops; — Kalytera will be able to protect its intellectual property; — Kalytera will be successful at managing the risks involved in the foregoing.
• The forward-looking statements are based upon management’s beliefs and assumptions and are made as of the date of this presentation. Kalytera undertakes no obligation to update or revise any forward-looking statements included in this presentation. You should not place undue reliance on these forward-looking statements.
• Development Status: We do not have approval from the U.S. Food and Drug Administration (“FDA”) or any other governmental agency, whether in the U.S. or abroad, to sell or market any product to treat or cure any disease or condition, including our drug candidates that we hypothesize may, following further study, clinical trials and all required approvals, be used to treat graft versus host disease, or acute or chronic pain. Our drug candidates have not completed the approval process (including, but not limited to clinical trials) that is required by the FDA. Our drug candidates have not been proven safe and effective and may not receive FDA approval. We do not currently sell any drug products or other treatments.
About Kalytera
• Canadian Corporation: (TSXV: KALY and OTCQB: KALTF)
• Executive Office: San Francisco, CA
• R&D Center: Tel Aviv, Israel
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CBD and Proprietary Cannabinoids
• Developing Pharmaceutical CBD
• Developing Proprietary Cannabinoids
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How to “Pharmaceuticalize” CBD
• CBD is available everywhere (online, dispensaries) • Limited IP protection for CBD
• No composition of matter IP • Method of use IP is available
• Keys to successful commercialization of CBD • Method of use IP – market exclusivity for specific use • Orphan drug exclusivity • Most importantly – an indication where non-prescription CBD can’t compete
• GVHD (Kalytera) • Juvenile epilepsy (GW Pharmaceuticals)
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Product Pipeline
PROGRAM PRECLINICAL PHASE 1 PHASE 2 / PHASE 3
Lead Programs with CBD
Prevention of aGVHD
Treatment of aGVHD
Proprietary Cannabinoid Programs
Acute / Chronic Pain
Psoriasis
Concussions
Sepsis Associated Renal Failure
Colitis / Crohn’s Disease
Acute Respiratory Distress Syndrome
CBD for Prevention and Treatment of Graft Versus Host Disease (“GVHD”) • GVHD: a serious and life-threatening complication commonly occurring after bone marrow transplant procedures
• GVHD: acute and chronic illness, infections, disability, reduced quality of life, and death
Our Lead Program CBD for GVHD
Our Lead Program CBD for GVHD
Symptoms
Immune system disorder – transplanted donor cells attack the patient’s organs: • Skin • Liver • Lungs • Eyes
• GI tract - epithelial cell damage – loss of sight junction integrity
Number of bone marrow transplants increasing in major markets:
GVHD – A Growing Market
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Our Lead Program CBD for GVHD
Market Projections
January 2018 Market Forecast Report by DelveInsight Perspective: • Projected annual sales in the 7 major markets (the U.S., Germany, France, Italy, Spain, the U.K. and Japan)
• Projected 2018: more than USD $408 million • Projected 2027: approximately USD $1.3 billion
Our Lead Program CBD for GVHD GVHD – A Growing Market
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• No FDA approved drugs for either prevention or treatment of GVHD
• Current standard of care: high dose steroids (with limited efficacy)
• Cyclosporine
• Methotrexate
Our Lead Program CBD for GVHD Limited Competition
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Our Lead Program CBD for GVHD Strong IP
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2 issued U.S. patents:
• Use of CBD in prevention of GVHD – through 2034
• Use of CBD in treatment of GVHD – through 2034
• Additional patent applications in EU and other jurisdictions
• 4 orphan drug designations for the prevention and treatment of GVHD in the U.S. and Europe.
Our Lead Program CBD for GVHD Data from Prior Studies
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• 4 Phase 2a clinical studies complete
• Study 1: 48 patient study in prevention of GVHD
• Study 2: 12 patient study in prevention of GVHD
• Study 3: 10 patient study in treatment of acute GVHD
• Study 4: 18 patient study in chronic GVHD • Exceptional, unprecedented results
Our Lead Program CBD for GVHD Study 1
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• 48-patient study evaluating CBD in prevention of GVHD
• All patients received standard treatment (generic immuno-suppressants)
• All patients received CBD for7 days prior to bone marrow transplant and for 30 days after
• Published study: Biology of Blood and Marrow Transplantation
Our Lead Program CBD for GVHD Study 1: Results
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• No patients developed acute GVHD while being treated with CBD
• The rates of grades 2-4 acute GVHD by day 100 were 12.1%, compared with 46% in 101 historical control
subjects
• CBD was found to be safe and well tolerated
Our Lead Program CBD for GVHD Study 2
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• 12-patient study evaluating CBD in prevention of GVHD
• All patients received standard treatment (generic immuno-suppressants)
• All patients received CBD for 7 days prior to bone marrow transplant and for up to 100
days after
Our Lead Program CBD for GVHD Study 2: Results
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• No safety issues observed
• Significant reductions in incidence of GVHD
• 17% of patients in the CBD treatment group developed grades 2-4 acute GVHD, compared to a
46% incidence predicted by historical data
Our Lead Program CBD for GVHD Study 3
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• 10-patient study evaluating CBD in treatment of acute GVHD
• All patients with steroid refractory grades 3-4 GVHD
• Grade 3: n = 5
• Grade 4: n = 5
• Expected 12-month mortality rates in patients with steroid refractory grades 3-4 GVHD
• Grade 3 GVHD: 60% - 70%
• Grade 4 GVHD: 80% - 100%
Our Lead Program CBD for GVHD Study 3: Results
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• 9 of 10 patients responded to treatment
• 7 complete remissions
• 2 very good partial remissions
• 1 patient death (within 3 days of study initiation)
• 6 patients are still alive with a median follow-up period of 23 months (range 15-30 months)
• In historical control group: 26 of 29 patients died from GVHD and its complications within 12 months
Our Lead Program CBD for GVHD Study 3: Results
31 year-old patient with acute Grade 4 GVHD (refractory to steroid treatment):
Grade 4 Acute GVHD of the skin before treatment Same patient after treatment with CBD
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Our Lead Program CBD for GVHD CBD Mechanisms of Action in GVHD
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Two Methods of Action:
• Repair of damage to epithelial cells and loss of tight junction integrity
• CBD up regulates expression of occludin
• CBD decreases immune response by diminishing Th17 cells, resulting in
reduction of immune attack on tissues
• In treatment of acute GVHD: Phase 2 study to begin later this year
• 45 patient, multinational, placebo controlled, randomized clinical trial in up to 25 sites in Australia, Israel, The United Kingdom and the U.S.
• Phase 3 study to begin late 2019
• Breakthrough Therapy and Fast Track Designations
Our Lead Program CBD for GVHD
• In prevention of GVHD: Ongoing 36-patient Phase 2b clinical study
• Patients enrolled at clinical sites in Israel
• Expanding study to include 2 additional sites in Australia
• Expected to be completed early next year (2019)
• Phase 3 study to begin Q3 2019
Development Plan Next Steps
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Proprietary Cannabinoid for Pain
• Patent pending cannabinoid / naproxen conjugate • 2 active agents, cannabinoid and naproxen • Potential for effective pain reduction
• Potentially superior safety profile: • No risk of addiction or respiratory suppression • Water soluble, allowing for treatment of acute pain in in-patient settings, such as childbirth, short surgical procedures, and post-operative pain care
• Strategy: • Advance compound through Phase 1 and Phase 2, then seek to out-license or sell to multinational pharmaceutical company • Commercial opportunity for this program could be very significant
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Other Proprietary Cannabinoids
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August2018
Kalytera Therapeutics, Inc. TSXV: KALY
41 Thunderbird Drive Novato, CA 94949 Telephone: (888) 861-2008 Email: [email protected]