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Company Overview

Kalytera Therapeutics (TSXV: KALY) is a clinical-stage pharmaceutical company developing cannabidiol (“CBD”), and next-generation cannabinoid therapeutics, for the treatment of serious and life threatening human disease, with an initial focus on graft versus host disease (“GVHD”).

 

In our lead program, we are evaluating CBD for the prevention and treatment of graft versus host disease (“GVHD”). Our GVHD program is in late-stage clinical testing. We have an ongoing Phase 2 clinical study in prevention of GVHD, and we expect to initiate a seamless Phase 2-3 pivotal registration study in treatment of acute GVHD later this year. We have two issued U.S. patents covering the use of CBD in the prevention treatment of GVHD, as well as four orphan drug designations for the treatment and prevention of GVHD in the U.S. and Europe.

In addition to our lead program in GVHD, we have also initiated a preclinical program to develop a novel, proprietary cannabinoid compound for the treatment of acute and chronic pain. Our compound consists of a next-generation cannabinoid compound conjugated with naproxen, a generic, non-steroidal, anti-inflammatory drug that is already approved for treatment of pain. This cannabinoid/naproxen conjugate has potential to become a next generation pain medication, without the risks of addiction or respiratory suppression that exist with opioid analgesics. We have found a way to make this compound water soluble, which will allow for treatment of acute pain in in-patient settings, such as childbirth, short surgical procedures, and post-operative pain care. We have applied for patent coverage in the U.S, Europe and other jurisdictions for this novel cannabinoid compound for the treatment of pain.

 

Q Graft versus Host Disease (

Kalytera is developing a clinical-stage cannabidiol (“CBD”) medicine to prevent and treat graft versus host disease (“GVHD”). GVHD is a multisystem disorder that is a life-threatening complication commonly occurring after bone marrow transplant procedures. GVHD occurs when the transplanted donor cells attack the patient’s organs, including the skin, gastrointestinal tract, liver, lungs, and eyes. GVHD is associated with acute and chronic illness, infections, disability, reduced quality of life, and death. Learn more >>

The commercial opportunity for our CBD therapeutic in the prevention and treatment of GVHD is large. According to the 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) is estimated to be more than USD $408 million in 2018, and could grow to approximately USD $1.3 billion by 2027.

Q Acute and Chronic Pain Program

Kalytera has initiated a novel program for the treatment of acute and chronic pain through the development of a compound that consists of a cannabinoid conjugated with naproxen, a generic, non-steroidal, anti-inflammatory drug that is already approved for treatment of pain. The objective of Kalytera’s new program is to develop a potent, non-psychotropic, oral analgesic for intractable pain that will be safe and well tolerated.

By combining both molecules into a single drug, Kalytera has designed a next generation pain medication that may maximize the activation of the alpha3 glycine receptor pathway for treatment of intractable pain. To our knowledge, no company has introduced into the market an agent specifically targeting this receptor. The initial route of administration will be oral, Kalytera will also seek to develop an intravenous formulation

Q Additional Preclinical Programs

Kalytera seeks to advance a portfolio of synthetic, non-psychoactive cannabis-like molecules. By modifying cannabinoid molecules, and molecules which regulate the endogenous cannabinoid signaling system, Kalytera seeks to improve pharmacokinetics and increase potency, potentially allowing for the development of drug candidates with improved activity.

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