Kalytera Therapeutics, Inc. (TSXV: KALY), a clinical stage biopharmaceutical company developing next generation cannabinoid-derived therapeutics, today announced it has applied for a $5 million grant from the Israel Innovation Authority (“IIA”) to fund development of its portfolio of novel cannabidiol (“CBD”) prodrugs.
IIA, formerly known as the Office of the Chief Scientist of the Ministry of Economy (or “MATIMOP”), which is responsible for the country’s innovation policy, is an independent and impartial public entity that operates for the benefit of the Israeli innovation ecosystem and Israeli economy as a whole.
Many of the world’s top-tier biopharmaceutical scientists, CROs and expert research facilities specializing in cannabis are located in Israel, including several of Kalytera’s senior scientific staff and advisors. Accordingly, Israel is widely acknowledged as the global center for FDA and EMEA-compliant pharmaceutical research on cannabis and its molecular constituents such as CBD. It is the ideal location for Kalytera, whose business model is to develop cannabidiol-derived, FDA-approved medicines for global distribution.
Kalytera has applied for the grant to support further development of its portfolio of novel cannabidiol prodrugs, all of which were invented by Kalytera,. Kalytera’s CBD prodrugs are listed below:
- K-1012, indicated for Acute Respiratory Distress Syndrome (“ARDS”), with an estimated 280,000 patients just in the US and a $700 million addressable market.
- K-1022, indicated for Ulcerative Colitis (also known as Irritable Bowel Syndrome, or “IBS”), with an estimated 800,000 US patients and a $10 billion addressable market.
- K-1032, indicated for Acne Vulgaris, with an estimated 45 million patients in the US and the five other major markets with a $4 billion addressable market.
- K-1052, being studied as an Inducible Nitric Oxide Synthase Inhibitor, indicated for Sepsis Associated Renal Failure & Severe Traumatic Brain Injury (“TBI”) with an estimated 216,000 patients in the US and the five other major markets with a $2.4 billion addressable market.
In addition to its portfolio of prodrugs, the Company is developing a portfolio of CBD analogue or synthetic derivative drugs for the treatment of bone disease or disorders:
- KAL436 and KAL439, two compounds Kalytera is investigating to assess their potential ability to improve bone fracture healing. KAL436 and KAL439 are both synthetic derivative compounds of CBD that have been structurally modified to enhance solubility in water to improve potency. In the U.S., bone fractures account for an estimated 10.2 million visits to hospitals and physician offices. Worldwide, more than 50 million fractures occur every year. Osteoporosis is the most common cause of fractures and the prevalence of it and low bone mass is expected to increase in coming years due primarily to the aging of the population.
- KAL671, a unique synthetic fatty acid amide and an endocannabinoid-like molecule that may restore bone in persons suffering from osteoporosis, the most common bone disease. The global osteoporosis drugs market was valued at $8.4 billion in 2013 and is projected to reach $8.9 billion by 2020.
The Company anticipates receiving a decision from the IIA on its grant application in the third quarter of this year. The grant, if approved, will be non-dilutive to shareholders in the form of a conditional, non-recourse loan to be paid back from future royalties.
Commenting on its recent IIA grant application, Dr. Andrew L. Salzman, CEO of Kalytera, said, “Kalytera is developing an entirely new generation of CBD-derived medicines — for FDA and EMEA pathways to commercialization — offering increased efficacy and far less side effects (improved safety profile) to treat serious and chronic disease. Our science is viewed favorably by the biotechnology industry and is a strong candidate for grants such as those offered by the IIA.
“We have a world-class management team, and Boards of Directors and Advisors, composed of cannabis biotech industry leaders in Israel and the US enabling Kalytera to capitalize on opportunities worldwide to bring our proprietary pipeline of drugs to clinical stage and commercialization,” he added. “Concurrently with our research on the prodrugs and synthetic compounds, we are advancing our clinical research on CBD to treat GvHD, whose data from a recent Phase 2a study announced February 22, were encouraging.”
Kalytera (TSXV: KALY) is a clinical-stage pharmaceutical company pioneering the development of a next generation of cannabinoid therapeutics. Through its proven leadership, drug development expertise, and growing 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 (“GvHD”).
Kalytera is also developing a new class of proprietary cannabidiol (“CBD”) therapeutics. CBD is a remarkable compound that has shown activity against a number of pharmacological targets. However, there are limitations associated with CBD, including its poor oral bioavailability which greatly limits the efficacy of medical marijuana edible products that contain a high level of CBD.
Kalytera is developing innovative CBD formulations and prodrugs intended for commercialization as FDA and EMEA-approved prescription medications in an effort to overcome these limitations, and to target specific disease sites within the body. Kalytera has filed composition of matter and method of use patents covering its novel inventions to reinforce its barriers to entry.
This news release may contain “forward-looking information” within the meaning of applicable securities laws. Although Kalytera believes in light of the experience of its officers and directors, current conditions and expected future developments and other factors that have been considered appropriate, that the expectations reflected in this forward-looking information are reasonable, undue reliance should not be placed on them because Kalytera can give no assurance that they will prove to be correct. 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. The statements in this press release are made as of the date of this release. Kalytera undertakes no obligation to comment on analyses, expectations or statements made by third-parties in respect of Kalytera, its securities, or its respective financial or operating results (as applicable). Kalytera disclaims any intent or obligation to update publicly any forward-looking information, whether as a result of new information, future events or results or otherwise, other than as required by applicable securities laws.