Kalytera Therapeutics, Inc. (TSX VENTURE: KALY and OTCQB: KALTF) (the “Company” or “Kalytera”) today announced that it has begun development of a novel cannabinoid-based compound for the treatment of acute and chronic pain. Patents for this compound have been filed in the U.S. and other jurisdictions, and Kalytera has obtained an exclusive, worldwide license for this compound from Beetlebung Pharma, Ltd., an Israeli-based pharmaceutical discovery company focused on cannabinoid-based therapeutics for the treatment of human disease (“BPL”).

Use of cannabinoids in the treatment of pain is supported by data from many studies. According to results of a systemic review of randomized controlled trials published in the Journal of Neuroimmune Pharmacology,cannabinoids have demonstrated significant analgesic effects and were well tolerated.

Kalytera’s compound consists of a cannabinoid 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, and, based on the potentially complementary methods of action of the cannabinoid and naproxen, there is reason to believe these molecules may have a synergistic effect in treatment of pain, as well as a superior safety profile compared with opioid analgesics.

“We are pleased and excited to announce this new program in treatment of pain,” said Robert Farrell, President and CEO of Kalytera. “The promise of this novel compound is that the two active agents, the cannabinoid and naproxen, may provide effective pain reduction, without the risks of addiction or respiratory suppression that exist with opioid analgesics. We have also 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.”

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. The cannabinoid component will act as a cannabinoid receptor agonist, targeting the alpha3 glycine pain receptor in the spinal cord, and the naproxen component will block the synthesis of the pain-inducing molecule PGE2. Although the initial route of administration will be oral, Kalytera will also seek to develop an intravenous formulation.

The commercial opportunity for Kalytera’s cannabinoid/naproxen conjugate is large. According to a 2016 report by Transparency Market Research, the global pain management therapeutics market is projected to reach $83 billion by 2024. Current treatments for pain mainly include non-steroidal anti-inflammatory drugs (“NSAIDs”), such as naproxen, for mild to moderate pain, and opioids, such as morphine, for moderate to severe and chronic pain. Kalytera believes that its product will be suitable for mild to severe pain, without the risks of respiratory suppression and dependence associated with opioid analgesics.

“The potential synergy between this unique cannabinoid and naproxen in the treatment of pain holds great promise,” said Queensland Brain Institute Professor Joseph Lynch, Ph.D., a world authority on the biology of pain. “The cannabinoid analog that Kalytera is developing is designed to block pain by a dual action. First, their cannabinoid triggers the activation of a specialized protein in the spinal cord known as the alpha3 glycine receptor. To date, no company has introduced into the market an agent specifically targeting this receptor. When activated, the alpha3 glycine receptor potently blocks pain signals from being sent to the brain. Second, Kalytera has engineered its compound to insure the alpha3 glycine receptor is activated by a second mechanism. This is achieved by attaching naproxen to the cannabinoid in a manner that allows it to detach in the spinal cord and block the synthesis of the pain-inducing prostaglandin molecule PGE2. The combination of naproxen with the cannabinoid is crucial because PGE2 is known to shut down the alpha3 glycine receptor pathway. By combining both molecules into a single drug, Kalytera has designed a next generation pain medication that should maximize the activation of the alpha3 glycine receptor pathway for treatment of intractable pain.”

The program for treatment of pain that the Company has announced today is a first step in the expansion and diversification of its cannabinoid-based product development portfolio.
“The initiation of this program is an important first step in our overall strategy to expand and diversify,” stated Ron Erickson, Kalytera’s Chairman. “We have a late-stage clinical program with cannabidiol (“CBD”) in the prevention and treatment of graft versus host disease, and today we have added a program in the treatment of pain. The pain market is demanding safer and effective treatments, and we believe our novel cannabinoid/naproxen conjugate may meet that need. In addition, we are evaluating a number of other unique and novel cannabinoid conjugates with potential to address unmet medical needs in other markets.”

About Kalytera Therapeutics

Kalytera Therapeutics, Inc. (“Kalytera”) is pioneering the development of a next generation of cannabinoid therapeutics. Through its proven leadership, drug development expertise, and intellectual property portfolio, Kalytera seeks to establish a leading position in the development of novel cannabinoid medicines for a range of important unmet medical needs, with an initial focus on graft versus host disease and the treatment of acute and chronic pain.

About Beetlebung Pharma

Beetlebung Pharma Limited (BPL), an Israeli affiliate of SG International, focuses on the discovery and development of novel cannabis-related pharmaceutical therapeutics. SG International (the “Salzman Group”) provides clinical management and other services to Kalytera in connection with Kalytera’s programs evaluating CBD in the prevention and treatment of graft versus host disease. BPL has invented a broad range of cannabinoid new chemical entities in therapeutic areas encompassing pain, inflammation, autoimmunity, ischemia-reperfusion injury, and central nervous system injury. BPL is also active in the development of novel formulations of existing cannabinoids, terpenes, and sesquiterpenes that may contribute to the entourage effect. To provide scientific support for its pharmaceutical programs, BPL carries out biological research on terpenoid cell signaling and pharmacology in its basic research laboratories. In an effort to lower cost of goods of complex cannabinoid molecules intended for pharmaceutical use, BPL has invented a series of more efficient synthetic routes for manufacture of cannabidiol and related cannabinoids and is conducting process scale-up research in its pilot plant facilities to advance these products to the stage of commercial manufacturing. BPL is a private, closely held corporation.

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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. 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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