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Kalytera Announces Pre-IND Meeting Date with FDA

V.CLAS.H | July 5, 2018

SAN FRANCISCO and TEL AVIV, Israel, July 05, 2018 (GLOBE NEWSWIRE) -- Kalytera Therapeutics, Inc. (TSX VENTURE:KALY) (OTCQB:KALTF) (the "Company" or "Kalytera") today announced that it will meet with the Center for Drug Evaluation and Research (“CDER”) of the U.S. Food and Drug Administration (“FDA”) on Tuesday, July 31, 2018. The meeting is to discuss numerous aspects of Kalytera’s planned registration study evaluating cannabidiol (“CBD”) for the treatment of acute graft versus host disease (“GVHD”).

Kalytera’s President and CEO, Robert Farrell, commenting on the meeting said, “The meeting with CDER is an important next step in the advancement of our program in treatment of acute GVHD. We recently submitted questions to the FDA as part of our pre-IND submission package. With answers to these questions and any additional information provided by CDER during the meeting, we will be in position to address any open issues or requests of CDER before submitting our IND. Once the IND is submitted and found to be acceptable to the FDA, we will initiate our planned registration study in treatment of acute GVHD.”

Kalytera’s program is designed to meet a clear unmet medical need in patients with acute GVHD.
GVHD 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, GI tract, liver, lungs, and eyes. GVHD is associated with acute and chronic illness, infections, disability, reduced quality of life, and death. There is currently no FDA approved therapy for the treatment of acute GVHD.

Kalytera is the exclusive licensee of two issued U.S. patents covering the use of CBD in the prevention and treatment of GVHD, and is also the exclusive licensee of pending patent applications in other jurisdictions for the use of CBD in the prevention and treatment of GVHD.

The U.S. FDA has recommended that Kalytera apply for both Breakthrough Therapy and Fast Track Designations for our CBD products for prevention and treatment of acute GVHD, each of which could accelerate the approval process for these products.

Data Presented at 28^th Annual Symposium of the International Cannabinoid Research Society

Data from Kalytera’s previous clinical studies in both prevention and treatment of GVHD were discussed this week in an oral presentation at the 28^th Symposium of the International Cannabinoid Research Society held in Leiden, Netherlands. These data included previously announced results from Phase 2a clinical studies in both the prevention and treatment of acute GVHD, including data previously published in Biology of Blood and Marrow Transplantation (Cannabidiol for the Prevention of Graft-versus-Host-Disease after Allogeneic Hematopoietic Cell Transplantation: Results of a Phase II Study, M. Yeshurun et al. / Biology Blood Marrow Transplant 21 (2015) 1770 - 1775).

Kalytera’s Program Evaluating CBD in the Treatment of Acute GVHD

Kalytera is planning to initiate a seamless Phase 2-3 pivotal registration study in the treatment of acute GVHD later this year. This Phase 2-3 study will enroll approximately 135 patients and will assess the safety and efficacy of multiple doses of CBD for the treatment of acute GVHD. The study will be a multicenter, multinational, placebo controlled, randomized clinical trial, for the evaluation of the safety and efficacy of CBD for the treatment of grade 3-4 acute GVHD. The study will be conducted in up to 25 sites in Australia, Israel, The United Kingdom and the U.S. The Principal Investigator of the study is Edmund Waller, M.D., PhD., Professor, Hematology and Medical Oncology, Medicine, and Pathology at Emory University School of Medicine, and Director, Division of Stem Cell Transplantation and Immunotherapy at Winship Cancer Institute of Emory University.

Kalytera previously completed a Phase 2a clinical study in the treatment of acute GVHD entitled, Cannabidiol for the Treatment of Severe (Grades 3-4) Acute Graft versus-Host Disease. Dr. Moshe Yeshurun, Kalytera’s Chief Medical Officer, was the Principal Investigator for this study, which was conducted at the Institute of Hematology, Davidoff Center, Rabin Medical Center, Petah Tikva, Israel.

The results of this Phase 2a study were positive and highly encouraging. Nine of the ten patients responded to treatment, with seven achieving complete remissions, and with two achieving near-complete responses. Six patients are still alive with a median follow-up period of 13 months (range 5-30 months). These results compare favorably with the results of the historical control group of 29 patients with steroid-refractory grades 3-4 GVHD who were treated at the same institution in Israel (the Institute of Hematology, Davidoff Center, Rabin Medical Center), among which 26 patients died from GVHD and its complications.

About Kalytera Therapeutics
Kalytera Therapeutics, Inc. is pioneering the development of CBD therapeutics. Through its proven leadership, drug development expertise, and intellectual property portfolio, Kalytera seeks to establish a leading position in the development of CBD medicines for a range of important unmet medical needs, with an initial focus on GVHD and treatment of acute and chronic pain.

Website Home: https://kalytera.co/
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Cautionary Statements
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

This press release may contain certain forward-looking information and statements ("forward-looking information") within the meaning of applicable Canadian securities legislation, that are not based on historical fact, including without limitation in respect of its product candidate pipeline, planned clinical trials, regulatory approval prospects, intellectual property objectives and other statements containing the words "believes", "anticipates", "plans", "intends", "will", "should", "expects", "continue", "estimate", "forecasts" and other similar expressions. Readers are cautioned to not place undue reliance on forward-looking information. Actual results and developments may differ materially from those contemplated by these statements depending on, among other things, the risk that future clinical studies may not proceed as expected or may produce unfavourable results. Kalytera undertakes no obligation to comment on analyses, expectations or statements made by third parties, its securities, or financial or operating results (as applicable). Although Kalytera believes that the expectations reflected in forward-looking information in this press release are reasonable, such forward-looking information has been based on expectations, factors and assumptions concerning future events which may prove to be inaccurate and are subject to numerous risks and uncertainties, certain of which are beyond Kalytera's control. The forward-looking information contained in this press release is expressly qualified by this cautionary statement and is made as of the date hereof. Kalytera disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking information, whether as a result of new information, future events or otherwise.

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