Leading the Way in CBD Pharmaceuticals
This profile is part of a paid investor education campaign.*
Kalytera Therapeutics, Inc. (TSXV:KALY, OTCQB:KALTF) is a clinical-stage biotechnology company focused on the development of next generation cannabidiol (CBD) pharmaceutical products. The company is pioneering the use of CBD in the prevention and treatment of Graft versus Host Disease (GvHD), a disorder suffered by as much as 50 percent of bone marrow transplant patients. Clinical trials have shown CBD to be potentially efficacious in suppressing the immune-response of the graft cells while simultaneously improving the patient’s ability to fight off infections, both essential for the prevention and treatment of GvHD.
Kalytera is poised to reach a number of key value drivers in 2018 and 2019. The company initiated Phase 2 studies for the evaluation of CBD in the prevention of GvHD in December 2017 and results are expected in Q3 2018. Pending the outcome of those results, Phase 3 studies can begin shortly after with results anticipated for mid-2019.
“We expect to have a very nice inflection point in the company’s market valuation when Phase 2 is complete and we can begin preparing for Phase 3,” said President and CEO Robert Farrell. “At that point we will only be one step from applying for FDA approval as well as approval from other regulatory bodies.”
Kalytera will apply for both Fast Track and Breakthrough Status for the product with Fast Track approval anticipated by the end of 2020. According to research and consulting firm GlobalData, the GvHD market was valued at $295 million across the six major markets in 2013, and is expected to grow to $544 million by 2023.
In an effort to establish itself as a leader in the development of novel CBD pharmaceuticals, Kalytera plans to expand into larger markets addressing a range of important unmet medical needs. Investors can expect near-term catalysts as it expands its product development portfolio to include pantentable CBD pharma compounds for other disease indications.
The company is well managed by an of experienced team of financial and pharmaceutical industry professionals including President and CEO Robert Farrell with 25 years in the life science markets; Dr. Sari Prutchi-Sagiv who has lead scientific operations in multiple cannabis-based drug companies and raised capital via strategic partnerships for early stage technologies; and Director Gary Leong, the former Chief Scientific Officer at Jamieson Laboratories Limited, and the current Chief Scientific Officer of Aphria Inc., a Health Canada licensed producer of medical cannabis products.
- Phase 2 testing underway for the development of a CBD product for the prevention of GvHD
- Phase 3 clinical trials anticipated to begin in early 2019 pending Phase 2 results
- Orphan Drug Designation granted in the US and Europe
- No FDA approved therapies for the prevention or treatment of GvHD
- 2 patents issued covering the use of CBD for the prevention and treatment of GvHD in US
- Plans to expand the product development portfolio to CBD products for larger commercial marketplaces
- Management and Board stacked with experienced life science professionals
Primary Product: CBD Therapeutic for Graft versus Host Disease
Bone marrow transplantation is a lifesaving procedure for patients suffering from blood and bone marrow diseases including leukemia, Hodgkin and Non-Hodgkin lymphoma, multiple myeloma, sickle cell anemia, and thalassemia. About 50 percent of the 20,000+ patients that undergo such procedures each year will develop Graft versus Host Disease. The number of bone marrow transplants is expected to rise annually across the six major global markets.
GvHD is a life-threatening immune system reaction that occurs when the transplanted donor cells (graft) attack the patient’s (host) cells, causing nausea, vomiting, diarrhea and jaundice, and worst of all rashes and lesion on the skin, gastrointestinal (GI) tract, liver, lungs and eyes. The radiation therapy these patients have undergone prior to their transplant operation has already damaged the protective epithelial cells in the skin and GI tract, exposing the patient to the risk of infection. The onset of GvHD dramatically increases the patient’s vulnerability to infection and ultimately death by sepsis.
There are no FDA-approved therapies for the prevention or treatment of GvHD. The current standard of care, generic immuno-suppressants (steroids), have been ineffectual in the prevention and treatment of GvHD. The goal is to suppress the immune response that is causing the GvHD symptoms, however further suppression of the immune system ultimately increase the risk of a life-threatening infection.
In the face of mounting evidence, the mainstream medical establishment has begun to accept that cannabidiol is safe and has the potential to treat a broad range of medical conditions.
The key to preventing and treating GvHD is the immunosuppression of the graft cells while simultaneously improving the patient’s ability to fight off infections. Clinical trials have shown CBD can do both.
One of CBD’s most medically important attributes is its anti-inflammatory and immunosuppressive properties. Preliminary clinical trials of CBD in the prevention and treatment of GvHD show that CBD suppresses this immune response in the graft cells while promoting the production of occludin, an integral plasma-membrane protein that plays a critical role in the integrity of epithelial cells and their ability to maintain a natural barrier against infection.
The U.S. Patent and Trademark Office (“USPTO”) recently issued the company two patents covering the use of CBD for the treatment of GvHD. This grants Kalytera exclusive worldwide rights to this issued patent. The issuance of the 2nd patent in May 2018 completes the final step in the application process and provides patent coverage to the company for the use of CBD for the treatment of GvHD through May 2034 under the Exclusive License Agreement with Mor.
Kalytera’s GvHD Program
Kalytera acquired its GvHD Program from Israeli-based Talent Biotechs in early 2017 based on the stellar results of Talents’ four Phase 2a clinical studies in the prevention and treatment of GvHD using CBD. The studies were conducted under the scientific leadership of Dr. Moshe Yeshurun, whose primary field of research is GvHD following allogeneic hematopoietic cell transplantation. Dr. Yeshurun began researching the use of CBD for the prevention of GvHD following anecdotal evidence of symptom relief from patients who used marijuana.
Dr. Yeshurun is now Kalytera’s Chief Medical Officer and the Head of the Bone Marrow Transplantation Department at the Rabin Medical Centre in Tel Aviv.
The results of these four clinical studies were published in the Biology of Blood and Marrow Transplantation.
Phase 2a Clinical Study Highlights
- No patients developed acute GvHD while being treated with CBD
- The risk of developing acute GvHD by day 100 was decreased
- Among those that did develop GvHD after HCT, the time to onset was significantly longer (60 days in the CBD group versus 20 days in the historical control group)
- Patients treated with CBD had fewer skin and gastrointestinal issues compared to the control group
- CBD treatment was safe and well tolerated
These preliminary results support the continued investigation of CBD for the prevention and treatment of GvHD. Both the US FDA and the European Medicines Evaluation Agency (EMEA) have granted the product an Orphan Drug Designation. The FDA has encouraged Breakthrough Therapy and Fast Track Designations, which have the potential to accelerate the approval process.
Kalytera’s Phase 2 GvHD Prevention Study
Kalytera’s Phase 2 study currently underway is evaluating the pharmacokinetic and safety profile of multiple doses of CBD for the prevention of GvHD in 36 patients who have undergone bone marrow transplantation. The study is taking place at two major medical centers in Israel. The clinical study team is led by Dr. Daniel Couriel, Director of the Bone Marrow Transplant Program at the University of Utah Health Sciences, School of Medicine.
Kalytera expects to bring results to market in September 2018.
Robert Farrell—President and CEO
Robert Farrell has more than 25 years of experience in the pharmaceutical, biotechnology, and medical device sectors. Prior to joining Kalytera, Mr. Farrell worked as an executive officer with the Institute for OneWorld Health, an affiliate of the Bill and Melinda Gates Foundation. Mr. Farrell has held senior positions with publicly listed companies in the pharmaceutical and biotechnology industries, including Titan Pharmaceuticals, where he served as President and CEO from 2008 to 2009, and as Chief Financial Officer from 1996 to 2008. Mr. Farrell raised over $390M while at Titan via public equity and non-dilutive financings, including seven corporate partnerships. Prior to working with Titan, Mr. Farrell served as CFO, Corporate Group Vice President and General Counsel at Fresenius USA and Fresenius Medical Care, where he completed six corporate partnerships and M&A transactions totaling over $4B. Mr. Farrell received a law degree (J.D.) from the University of California, and his undergraduate degree (B.A.) from the University of Notre Dame.
Sari Prutchi-Sagiv—Chief Scientific Officer
Dr. Sari Prutchi-Sagiv has over 15 years of experience in various aspects of pharmaceutical development including discovery, regulatory affairs, intellectual property, business development, clinical trials, and marketing. Dr. Prutchi-Sagiv has lead scientific operations in multiple cannabis-based drug companies including Talent Biotechs and BOL Pharma. She serves as Director of Tech Transfer at Mor Research Applications (Clalit Health Services commercializing arm), where she is responsible for raising capital via strategic partnerships for early stage technologies. Dr. Prutchi-Sagiv holds an M.Sc. in Human Genetics and a Ph.D. in Cell Biology and Immunology from Tel Aviv University. In addition, she studied Business Administration at the Recanati School of Business at Tel Aviv University.
Moshe Yeshurun—Chief Medical Officer
Dr. Moshe Yeshurun is Head of the Bone Marrow Transplantation Unit at the Rabin Medical Center in Petah-Tikva Israel. Dr. Yeshurun’s primary field of interest and research is GvHD following allogeneic hematopoietic cell transplantation (“HCT”). Dr. Yeshurun has conducted several innovative clinical studies aiming to explore the role of CBD in the prevention and treatment of GvHD. Dr. Yeshurun received his M.D. degree from Tel Aviv University Sackler School of Medicine with distinction in 1990 and his board certification in Internal Medicine and Hematology in 1996 and 2002, respectively. Dr. Yeshurun completed a fellowship in bone marrow transplantation at Saint-Antoine and Saint-Louis hospitals in Paris, France. In 2007, he established the Bone Marrow Transplantation Unit at the Davidoff Cancer Center, Rabin Medical Center and has headed it since. Between the 2014 and 2017, Dr. Yeshurun was a committee member of the Israeli Society of Hematology and Transfusion Medicine.
Ronen Raviv—Director of Finance
Ronen Raviv obtained his Bachelor degree in Business with concentration in accounting in 2006 from San Francisco State University. Upon graduating, he joined the EY San Francisco Office, where he carried out audits of private and public companies in the Silicon Valley, among them Oracle Corporation (Ticker: ORCL) and salesforce.com (Ticker: SFDC). In 2008 Mr. Raviv relocated to the Tel Aviv office of EY, where he worked primarily with clients in the technology and defense industries. Mr. Raviv’s main client at EY was Elbit Systems Ltd. (Ticker: ESLT), the largest publicly owned defense contractor in Israel, with subsidiaries operating in multiple countries under different governmental and private contracts, among them contracts with US government. Mr. Raviv led over 15 audit teams engaged in the global audit of Elbit Systems Ltd and its subsidiaries. In his last position, as Corporate Controller of DarioHealth Corp. (Nasdaq: DRIO), Mr. Raviv facilitated the company’s up-listing process to the Nasdaq in March 2016.Mr. Raviv joined as our Director of Finance in January of 2017 to oversee the company’s global finance organization. His deep understanding of multi-national global organizations and extensive experience with executive teams, provide him with the leadership and insight that make him an integral part of our team.
Ronald Erickson is a senior executive with more than 30 years of experience in the high technology, telecommunications, micro-computer, and digital media industries. Mr. Erickson was the founder of Visualant, a developer of unique spectral pattern matching technology. He is formerly Chairman, CEO and Co-Founder of Blue Frog Media, a mobile media and entertainment company; Chairman and CEO of eCharge Corporation, an Internet-based transaction procession company; Chairman, CEO and Co-founder of GlobalTel Resources, a provider of telecommunications services; Chairman, Interim President and CEO of Egghead Software, Inc., a software reseller where he was an original investor; Chairman and CEO of NBI, Inc.; and Co-founder of MicroRim, Inc., the database software developer. Earlier, Mr. Erickson practiced law in Seattle and worked in public policy in Washington, D.C. and New York City. Additionally, Mr. Erickson has been an angel investor and board member of a number of public and private technology companies. In addition to his business activities, Mr. Erickson serves on the Board of Trustees of Central Washington University where he received his BA degree. He also holds a MA from the University of Wyoming and a JD from the University of California, Davis. He is licensed to practice law in the State of Washington.
Gary Leong is the Chief Scientific Officer of Aphria Inc., a Health Canada licensed producer of medical cannabis products. Gary has a personal background in quality assurance, quality control, quality system audits, international and domestic regulatory affairs and product research and development. Gary currently is the president of Neautrical Solutions Inc. located in Surrey, British Columbia. Prior to that, he was the Chief Scientific Officer at Jamieson Laboratories Limited. He began at Jamieson in the year 2000 as the Vice President of Scientific and Technical Affairs. He also held the position of Quality Control Manager at Boehringer Ingelheim Consumer Products: Quest Vitamins and Development Officer at Atomic Energy of Canada: Radiochemical Company. Gary’s educational background began with a Bachelors of Science in Chemistry and has taken him most recently to an MBA in Quality Management from City University of Bellevue Washington. Gary is currently affiliated with The Life Sciences Working Team of Windsor-Essex Economic Development Corporation. In the past, he was a member of the Natural Health Products Directorate Program Advisory Committee and a board member of the Ontario Ginseng Innovation and Research Consortium.
Dr. Jeff Paley, has been an Active Clinician and Consultant in the healthcare industry for the past 22 years, during which time Dr. Paley has consulted for over 30 analysts and portfolio managers in the biotechnology, pharmaceutical, specialty pharmaceutical, and medical technology arenas, reviewing the clinical, preclinical and regulatory pedigrees of numerous therapeutics and devices. Dr. Paley founded Access Medical Associates, PC in 2003, after spending five years on the full-time academic faculty of Weill Cornell Medical College, where he served as a Director of Clinical Research at the Cornell Internal Medicine Associates. At Weill-Cornell, Dr. Paley was a Principal or Co-Principal Investigator on several studies of diabetes, hypertension, and cholesterol disorders, including the landmark ACCORD study of intensive hyperglycemia, hypertension and hyperlipidemia management. Additional clinical interests include, sleep disorders, weight loss, adult attention-deficit disorder, and cardiovascular disease prevention. He has served as a Director of Retrophin, Kellbenx Inc., and Remote Radiology, Inc. He trained at Harvard Medical School and completed a residency in Internal Medicine at Massachusetts General Hospital. He holds a Bachelor’s Degree in mathematics and Rabbinic Ordination from Yeshiva University.
Raphael Mechoulam—Scientific Advisor
Dr. Raphael Mechoulam isa Professor Emeritus at Hebrew University, a pioneer in the cannabinoid field and a discoverer of the endocannabinoid system.
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