Kalytera Therapeutics, Inc. (TSXV: KALY) (OTCQB: KALTF), a clinical-stage pharmaceutical company developing cannabinoid therapeutics for Graft versus Host Disease (“GvHD”), today announced that Andrew L. Salzman, M.D., who previously served as Kalytera’s Chief Executive Officer and Chief Medical Officer, and as a member of Kalytera’s Board of Directors, will be leaving the Company, effective June 21, 2017. Robert Farrell, J.D., President and CFO of Kalytera, will assume the role of interim Chief Executive Officer (“CEO”). Concurrent with Mr. Farrell’s appointment as interim CEO, the Company has expanded its senior management team with three new appointments.
Joining Mr. Farrell as members of Kalytera’s leadership are David Bassa, Chief Operating Officer, Moshe Yeshurun, M.D., Chief Medical Officer, and Sari Prutchi-Sagiv, Ph.D., Chief Scientific Officer, each of whom previously held senior management positions at Talent Biotechs. As part of the Talent Biotechs team, Mr. Bassa, Dr. Yeshurun, and Dr. Prutchi-Sagiv, were instrumental in the development and advancement of the GvHD program, helping to conduct clinical studies in Israel that demonstrated exceptional results in the prevention and treatment of GvHD. Talent Biotechs was acquired by Kalytera in February 2017.
“I would like to thank Dr. Salzman for his many contributions to Kalytera, including his expert guidance during the acquisition of Talent Biotechs and its clinical-stage GvHD Program,” said Mr. Farrell. “In addition, Dr. Salzman has been instrumental in building Kalytera’s preclinical pipeline of cannabidiol (“CBD”) prodrugs, which have been designed to overcome certain limitations of CBD, including its ability to target specific disease sites within the body. We remain on track to advance our GvHD Program into clinical testing this year, supported by a highly capable leadership team with intimate knowledge of the program.”
Kalytera is seeking to establish a leading position in the development of cannabinoid medicines for a range of unmet medical needs. The Company is making preparations to advance its GvHD program into the next stage of clinical testing, and anticipates that it will begin patient enrollment in a Phase 2 clinical study evaluating CBD for the prevention of GvHD in the second half of 2017.
“It has been my honor to help lead Kalytera through an exciting period of growth and accomplishment,” said Dr. Salzman. “I am particularly proud of our work in GvHD, and in developing Kalytera’s portfolio of novel CBD prodrugs, which have potential to treat a number of conditions of important unmet need. I look forward to continuing to support Kalytera’s leadership to help effect a smooth transition.”
About Robert Farrell, J.D., President, CEO, and CFO
Mr. 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.
About David Bassa, Chief Operating Officer
Mr. Bassa is a leading Israeli entrepreneur operating in the biotech and high-tech industries. In 2000, Mr. Bassa founded Bio-Gal, a biopharmaceutical company that subsequently merged into XTL Biopharma (NASDAQ: XTLB) for the purpose of developing Erythropoietin (“EPO”) for the treatment of multiple myeloma. Mr. Bassa was the co-founder of Sela Software Systems Ltd., a leading knowledge center and software house for the high-tech and IT industry. Mr. Bassa graduated from Bar-Ilan University with a B.A. in Economics and an M.Sc. in Computer Science. Mr. Bassa was twice awarded the President Excellency Award (1981, 2002) and managed the Israeli branch of the international AIESEC organization, of which he is a Hall of Fame member.
About Sari Prutchi-Sagiv, Ph.D., Chief Scientific Officer
Dr. 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.
About Moshe Yeshurun, M.D., Chief Medical Officer
Dr. 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.
Kalytera Therapeutics is a clinical-stage pharmaceutical company developing 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 proprietary cannabidiol (“CBD”) prodrugs intended for commercialization as FDA and EMEA-approved prescription medications. CBD has shown activity against a number of pharmacological targets. However, there are limitations associated with CBD, including its poor oral bioavailability. Kalytera’s CBD prodrugs have been designed to overcome these limitations. In addition to licensed IP rights, Kalytera has filed composition of matter and method of use patents covering its inventions to reinforce its position in the market.
This news release contains “forward-looking information” within the meaning of applicable securities laws, including in respect of its product candidate pipeline, planned clinical trials, regulatory approval prospects, intellectual property objectives, management goals, capital raising abilities and other statements included in this news release of a forward-looking nature. 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.
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