DiaMedica Therapeutics Announces Formation of Scientific Advisory Board for Kidney Disease

MINNEAPOLIS, May 21, 2019 (GLOBE NEWSWIRE) -- DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for kidney diseases and neurological disorders, today announced the formation of a Scientific Advisory Board (“SAB”) for chronic kidney disease (“CKD”). The members of the SAB are world-leading experts in CKD and hypertension. The SAB will work closely with DiaMedica’s senior management team to advance the company’s lead product candidate, DM199, in the treatment of chronic kidney disease.

The members of DiaMedica Therapeutics’ Kidney Scientific Advisory Board include:

• George Bakris, M.D. is the Professor of Medicine and Director of the American Heart Association Comprehensive Hypertension Center at the University of Chicago Medical Center. Dr. Bakris was previously Vice-Chairman of Preventive Medicine and Director of the Rush University Hypertension Center in Chicago. He has published over 800 articles and more than 100 book chapters in the areas of hypertension, diabetic kidney disease and progression of nephropathy. He also served as an expert member on the Cardio-Renal Advisory Board of the FDA and was a special government expert to the FDA and CMS. He has served on many national guideline committees including: the Joint National Committee (“JNC”) Writing Groups VI & 7, the JNC 7 executive committee, the American Diabetes Association Clinical Practice Guideline Committee, the National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (“KDOQI”) Blood Pressure Guideline committee and the KDOQI Diabetes Guideline committee. Dr. Bakris is also the past president of the American College of Clinical Pharmacology and the American Society of Hypertension (“ASH”).
   
• Rajiv Agarwal M.D., MBBS, FASN is a tenured Professor of Medicine at Indiana University School of Medicine at Indianapolis, IN. Dr. Agarwal is an internationally recognized leader in the area of clinical and translational research in nephrology. He was amongst the first to demonstrate the effect of add-on angiotensin receptor blockade on cytokine production and oxidative stress, but none on proteinuria in patients with chronic kidney disease. He currently serves on Board of Directors of Kidney Disease: Improving Global Outcomes (“KDIGO”), the Editorial Board of Kidney International, Clinical Journal of American Society of Nephrology (“CJASN”), Hypertension and Seminars in Dialysis, and serves as an Editor for Nephrology Dialysis Transplantation, American Journal of Nephrology and the Journal of the American Society of Hypertension.
   
• Glenn M. Chertow, M.D., MPH, is the Chief of the Division of Nephrology at Stanford University School of Medicine, Norman S. Coplon Satellite Healthcare Professor of Medicine and (by courtesy) of Health Research and Policy. Dr. Chertow completed his medical education at Harvard, residency and fellowship in nephrology at Brigham and Women’s Hospital before joining the Harvard faculty. He then moved to the University of California San Francisco where he served as Director in the Division of Nephrology until he joined Stanford University. In addition to an active clinical practice, he has a robust clinical research program and served in key leadership roles for multiple National Institute of Diabetes and Digestive and Kidney Diseases (“NIDDK”), National Heart, Lung, and Blood Institute (“NHLBI”), Veterans Administration (“VA”) clinical trials and for several industry clinical trials. He has served as Associate Editor for the Journal American Society Nephrology (JASN) and is currently Co-Editor of Brenner and Rector’s The Kidney. Dr. Chertow was honored by the American Kidney Fund in 2007 with the National Torchbearer Award and in 2011 with the Nephrologist of the Year Award. Dr. Chertow was elected to the American Society of Clinical Investigation in 2004, and in 2015, received the Belding H. Scribner Award from American Society of Nephrology and was elected to the Association of American Physicians and the National Academy of Medicine. In 2018, Dr. Chertow received the David M. Hume Memorial Award from the National Kidney Foundation.
   
• Aldo Peixoto M.D. is a Professor of Medicine in the Section of Nephrology at the Yale University School of Medicine. He is also Associate Chair for Ambulatory Services Operations and Quality (Department of Internal Medicine) and Clinical Chief of the Section of Nephrology. He has published more than 100 peer-reviewed articles and book chapters in nephrology and hypertension, and is the author of a book on bedside diagnosis. He is an associate editor of Blood Pressure Monitoring and is on the editorial board of the American Journal of Nephrology and the Brazilian Journal of Nephrology. Dr. Peixoto also serves as reviewer for many internal medicine, nephrology and hypertension journals.
   
• Charles Herzog M.D. is a professor of medicine at the University of Minnesota, and cardiologist at Hennepin County Medical Center (“HCMC”) for 34 years. He founded the program in interventional cardiology at HCMC and served as cardiac catheterization laboratory director from 1985-1991, and cardiac ultrasound laboratory director from 1997-2012. He was director of the United States Renal Data System (“USRDS”) Cardiovascular Special Studies Center from 1999-2014. He participated in the development of the KDOQI Guidelines for Cardiovascular Disease in Dialysis Patients and KDIGO Clinical Practice Guidelines on Acute Kidney Injury, and the KDIGO 2017 Clinical Practice Guidelines Update for CKD-Mineral and Bone Disorder. He co-chaired the 2010 KDIGO Controversies Conference, “Cardiovascular Disease in CKD: What is it and What Can We Do About It?” and is a co-chair of the KDIGO Kidney, Heart, and Vascular Conference Series. He was an Executive Committee member of the EVOLVE Trial. He chairs the Renal Committee of the ISCHEMIA-CKD Trial and Critical Event Committee of the CARSK Trial, and was Co-PI of the WED-HED (Wearable Cardioverter Defibrillator in Hemodialysis Patients) Study. He currently co-chairs the workgroup, “Understanding and Overcoming the Exclusion of Patients with Kidney Disease from Cardiovascular Trials”, for the Kidney Health Initiative (“KHI”). Dr. Herzog has over 250 published papers. His special interests include cardiac disease and CKD, and echocardiography.

“We are honored for the opportunity to work with leading experts as we develop our lead product candidate, DM199, as a groundbreaking advancement for the treatment of patients with CKD," commented Dr. Alcorn, Chief Medical Officer. “Importantly, the formation of our Kidney SAB demonstrates the scientific and clinical enthusiasm for DM199’s potential to improve the lives of CKD patients. We look forward to working with our advisors to assist us in the clinical development of DM199 for patients with CKD.”

About DM199

DM199 is a recombinant (synthetic) form of the human serine protease, KLK1. The KLK1 protein plays an important role in the regulation of diverse physiological processes including blood flow, inflammation, fibrosis, oxidative stress and neurogenesis via a molecular mechanism that increases production of nitric oxide, prostacyclin and other anti-inflammatory mediators. KLK1 deficiency may play a role in multiple vascular and fibrotic diseases such as chronic kidney disease, retinopathy, stroke, vascular dementia, and resistant hypertension where current treatment options are limited or ineffective. DiaMedica is the first company to have developed a pharmaceutically active recombinant form of the KLK1 protein for human study. The KLK1 protein, produced from porcine pancreas and human urine, has been used to treat patients in Japan, China and Korea for decades. DM199 is currently being studied in patients with acute ischemic stroke and patients with chronic kidney disease.

About DiaMedica Therapeutics

DiaMedica Therapeutics Inc. is a clinical stage biopharmaceutical company focused on developing novel treatments for chronic kidney diseases and neurological disorders. DiaMedica’s shares are listed on The Nasdaq Capital Market under the trading symbol “DMAC.”

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and forward-looking information that are based on the beliefs of management and reflect management’s current expectations. When used in this press release, the words “estimate”, “believe”, “anticipate”, “intend”, “expect”, “plan”, “will,” “may” or “should”, the negative of these words or such variations thereon or comparable terminology and the use of future dates are intended to identify forward-looking statements and information. The forward-looking statements and information in this press release include statements regarding the anticipated clinical success of DM199, the timing of its clinical programs, groundbreaking advancement for the treatment of patients with CKD and potential to improve the lives of CKD patients. Such statements and information reflect management’s current view and DiaMedica undertakes no obligation to update or revise any of these statements or information. By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements, or other future events, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Applicable risks and uncertainties include, among others, DiaMedica’s plans to develop, obtain regulatory approval for and commercialize its DM199 product candidate for the treatment of CKD and acute ischemic stroke (“AIS”) and its expectations regarding the benefits of DM199; DiaMedica’s ability to conduct successful clinical testing of DM199; the perceived benefits of DM199 over existing treatment options; ability to obtain required regulatory approvals; the potential size of the markets for DM199 and its ability to serve those markets; the success, cost and timing of planned clinical trials, as well as reliance on collaboration with third parties to conduct clinical trials; its ability to obtain funding for its operations, including funding necessary to complete planned clinical trials and obtain regulatory approvals for DM199 for CKD and AIS, and the risks identified under the heading “Risk Factors” in DiaMedica’s annual report on Form 10-K for the fiscal year ended December 31, 2018, and subsequent SEC filings by DiaMedica. The forward-looking information contained in this press release represents the expectations of DiaMedica as of the date of this press release and, accordingly, is subject to change after such date. Readers should not place undue importance on forward-looking information and should not rely upon this information as of any other date. While DiaMedica may elect to, it does not undertake to update this information at any particular time except as required in accordance with applicable laws.

Contact:
Scott Kellen
Chief Financial Officer
Phone: (763) 496-5118
skellen@diamedica.com

Paul Papi
Vice President of Business Development
Phone: (617) 899-5941
info@diamedica.com

Released May 21, 2019