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MINNEAPOLIS, MINNESOTA – (Marketwired) – May 1, 2017 – DiaMedica Therapeutics Inc. (TSX-V: DMA) (OTCQB: DMCAF), today announced that the U.S. Patent and Trademark Office has issued U.S. Patent No. 9,616,015, entitiled “Formulation of Human Tissue Kallikrein-1 for Parenteral Delivery and Related Methods” for DM199. The patent protects the methods of parenterally administrating DM199 to patients in need where absorption into the circulation via methods such as intravenous (“IV”) or subcutaneous administration improves systemic pharmacokinetics (“PK”), bioavailability, safety, and/or convenience related to IV or other forms of administration. The patent has an expiration date of 2035, which does not include any potential patent term extension. “We are very excited to have received additional patent protection covering parenteral delivery, including subcutaneous and IV administration and related methods. We believe these methods of delivery could more completely address the needs of patients by offering better options for acute and chronic therapy.” - Rick Pauls, President and CEO. In a recent clinical trial, a dose of DM199 administered via IV infusion mimicked the anticipated drug profile of IV-administered urinary KLK1 (Kailikang®). This study also identified a dose of DM199 via subcutaneous injection having a superior PK profile that maintains KLK1 levels throughout day. The Company believes this profile could improve the efficacy of DM199. About DiaMedica Therapeutics Inc. DiaMedica Therapeutics is a clinical stage biopharmaceutical company focused on developing novel treatments for neurological and kidney diseases. DiaMedica's shares are listed on the TSX Venture Exchange under the trading symbol "DMA" and on the OTCQB under the trading symbol "DMCAF". For more information, please vist www.diamedica.com.
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MINNEAPOLIS, MINNESOTA--(Marketwired - April 25, 2017) - DiaMedica Therapeutics Inc. (the "Company") (TSX VENTURE:DMA)(OTCQB:DMCAF) is pleased to announce the addition of Dr. Nancy Chang to its Strategic Advisory Board to support the Company's development of its lead product, DM199. Dr. Chang brings more than 30 years of experience in the biopharmaceutical industry, successfully developing and commercializing therapeutic and diagnostic products. She is the co-founder of Tanox, Inc., a biotechnology company known for the development of Xolairâ, the breakthrough drug which changed the treatment model for allergy-induced asthma. Dr. Chang served as President and CEO of Tanox until its acquisition in 2007 by Genentech for US$919 million. "We are delighted to have attracted such an accomplished research scientist, businesswoman, and philanthropist as Dr. Chang to add to the quality and depth as a Strategic Advisory Board member. We believe the combination of Dr. Chang's scientific experience in developing best-in-breed products for significant unmet medical needs in treating major human neurological and endocrine diseases and her business acumen in the U.S., European, and Asian biopharmaceutical industry will bring a unique perspective to our clinical development program, as well as licensing and partnership opportunities." - Rick Pauls, President and CEO of DiaMedica Therapeutics  Dr. Nancy Chang is the co-founder of Tanox, Inc., a Houston-based biopharmaceutical company focused on the development of therapeutics to address major unmet medical needs in the areas of asthma, allergy, inflammation, aged macular degeneration and other diseases affecting the human immune system. She served the roles of President, CEO, and Chairman until its acquisition in 2007 by Genentech. Prior to Tanox, Dr. Chang held several leadership positions at Centocor, now a division of Johnson & Johnson, where she conducted pioneering work in the field of HIV/AIDS research and was instrumental in developing the first diagnostic assay to detect HIV infection. Dr. Chang received her PH.D. in biological chemistry from Harvard University and conducted her post-doctoral research at the Roche Institute of Molecular Biology.
Dr. Chang currently serves as President and CEO of Apex Enterprises, an investment management company focusing on healthcare, education and socially responsible ventures. Previously, she served as the Chairperson and Senior Managing Director of Caduceus Asia Partners Fund at OrbiMed Advisors L.L.C., one of the largest healthcare-focused investment firms. Dr. Chang has served on the board of directors of several organizations, including: The Federal Reserve Bank of Dallas' Houston Branch, BioHouston, and Charles River Laboratories International, Inc. About DiaMedica Therapeutics Inc. DiaMedica Therapeutics is a clinical stage biopharmaceutical company focused on developing novel treatments for neurological and kidney diseases. DiaMedica's shares are listed on the TSX Venture Exchange under the trading symbol "DMA" and on the OTCQB under the trading symbol "DMCAF". For more information, please visit www.diamedica.com. Follow DiaMedica on social media - Twitter, LinkedIn.  MINNEAPOLIS, MINNESOTA--(Marketwired - April 18, 2017) - DiaMedica Therapeutics Inc. (the "Company") (TSX VENTURE:DMA)(OTCQB:DMCAF), a biopharmaceutical company focused on the development of DM199 (recombinant human KLK1), is pleased to announce it has completed a non-brokered private placement with a prominent U.S. investor (the "Offering") with the issuance of 10,526,315 units (the "Units") at an issue price of USD$0.19 (CAD$0.25) per Unit for gross proceeds of approximately USD$2,000,000. The proceeds will be used by the Company to advance its research and development program, including DM199 for the treatment of neurological and kidney diseases, and for general corporate purposes. "The U.S. based life science investor has numerous academic, national, and international awards for leadership and contributions to the biopharmaceutical industry. The investor's deep understanding of recombinant proteins, as well as her experience and understanding of the biopharmaceutical industry in the U.S., Europe, and Asia, makes the investment in DiaMedica an excellent strategic combination." - Rick Pauls, President and CEO of DiaMedica Therapeutics Each Unit consisted of one common share and one-half of one common share purchase warrant, with each whole warrant entitling the holder thereof to acquire one additional common share at an exercise price of USD$0.23 (CAD$0.31) per share until 5:00 p.m. (Central Time) on the date that is: (i) twenty-four months after the date of issuance, or (ii) if on any date (the "Accelerated Exercised Date") (a) the volume-weighted average closing trading price of the common shares on any recognized Canadian stock exchange equals or exceeds USD$0.30 for a period of 10 consecutive trading days, then, at the Company's sole discretion and upon the Company sending the holder written notice of such Accelerated Exercise Date (the "Notice") and issuing a news release announcing such Accelerated Exercise Date (the "News Release"), the day that is 21 days following the later of: (i) the date on which such Notice is sent to the holder; and (ii) the date on which the News Release is issued. The common shares and warrants issued by the Company under the Offering are subject to restrictions on resale in accordance with applicable securities laws and the policies of the TSX Venture Exchange. These restrictions will expire four months and a day following the issuance of the Units. The Offering is subject to final acceptance by the TSX Venture Exchange. About DiaMedica Therapeutics DiaMedica Therapeutics is a clinical stage biopharmaceutical company focused on developing novel treatments for neurological and kidney diseases. DiaMedica's shares are listed on the TSX Venture Exchange under the trading symbol "DMA" and on the OTCQB under the trading symbol "DMCAF". Follow @DiaMedica on Twitter. MINNEAPOLIS, Minnesota--(Marketwired) - DiaMedica Therapeutics Inc. (TSX VENTURE:DMA)(DMCAF), today announced that the European Patent Office has issued European Patent No. 2854841, entitled "Human Tissue Kallikrein 1 Glycosylation Isoforms". This patent contains claims that cover the composition of matter of DiaMedica's product candidate, DM199, and pharmaceutical compositions comprising DM199. The patent protects key composition of matter of DM199's proprietary recombinant kallikrien protein. The patent has an expiration date of 2033, which does not include any potential patent term extension. The expanded patent protection adds European protection to DiaMedica's intellectual property portfolio related to DM199 that includes U.S. Patent No. 9364521 which provides expanded composition of matter protection for DM199. DiaMedica also recently filed new worldwide patent coverage, including in the U.S., Europe, China and Japan for dosing, route of administration, formulation and for numerous indications that would expire in 2037. The filings was based on recent clinical trial results and related matter. "We are delighted to announce the issuance of the composition of matter patent in Europe for DM199, which we believe affords broad, foundational composition of matter protection for our compound," commented Rick Pauls, President and CEO of DiaMedica. "We plan to continue to expand and fortify our intellectual property estate for DM199 via expanded worldwide patent coverage including in the U.S., Europe, Japan, and China. We also continue to maintain proprietary manufacturing know-how and trade secrets as we advance DM199 into Phase II clinical trials starting in the upcoming months." About DiaMedica Therapeutics Inc. DiaMedica Therapeutics is a clinical stage biopharmaceutical company focused on developing novel treatments for neurological and kidney diseases. DiaMedica's shares are listed on the TSX Venture Exchange under the trading symbol "DMA" and on the OTCQB under the trading symbol "DMCAF". For more information, please vist www.diamedica.com. MINNEAPOLIS, Minnesota, March 13, 2017 /Marketwired/ -- DiaMedica Therapeutics Inc. (the "Company") (TSX-V: DMA) (OTCQB: DMCAF), a clinical stage biopharmaceutical company developing synthetic protein treatments for neurological and kidney diseases, reported positive results from its Phase 1b bridging trial. The study was designed to compare the profile of DM199 to the approved urinary KLK1 product (trade name Kailikang®) on the market in Asia for acute ischemic stroke. The reference drug is administered intravenously and has a very short half-life. The DiaMedica study identified an intravenous dose of DM199 having a similar profile to urinary KLK1. Today the Company is reporting an improved subcutaneous dose of DM199 producing sustained plasma levels superior to the reference drug. The Company plans to use the results of this study to guide Phase II dosing in upcoming clinical trials. The DM199 subcutaneous delivery provides sustained levels of the KLK1 protein, offering a potentially superior profile to the reference drug, which has a very short exposure window. The dosing of DM199 will be significantly more convenient and potentially provide improved efficacy to the short half-life of the reference drug. DM199 has the same amino acid sequence as the reference drug, identical biochemical activity, and demonstrated similar physiological effects. "We are very pleased to have identified an intravenous dose of DM199 that mimics the currently approved version of the drug and a new subcutaneous delivery option that could provide sustained therapeutic levels of DM199 for acute ischemic stroke," said Dr. Todd Verdoorn, Chief Scientific Officer of DiaMedica. "This study identified what we believe is an optimal dosing of DM199, fully supporting upcoming Phase II trial in stroke patients." The Phase 1b controlled trial tested DM199 in 36 healthy volunteers, who received either one of four 30-minute intravenous infusions or a single subcutaneous injection. Plasma DM199 concentration, biomarker concentrations, and other safety and pharmacokinetic parameters were measured in the trial. No treatment-limiting adverse events were reported in any dose group. The Company plans to publish the full results of the study in a peer reviewed journal. About DM199 DM199 is a recombinant (synthetic) human tissue kallikrein ("KLK1") protein to treat neurological and kidney diseases. DiaMedica has completed five clinical trials with DM199, including single ascending and multiple ascending doses, studies in diabetic patients, and the current bridging study. In addition to a good safety and tolerability profile, DM199 showed the anticipated activity, lowering blood pressure over the course of treatment in multiple clinical studies. In a recent preclinical study, DM199 significantly increased cerebral blood flow. About KLK1 in Asia Two forms of the KLK1 protein are approved in Asia for the treatment of acute ischemic stroke and diabetic nephropathy (diabetic kidney disease). A human urinary KLK1 (Kailikang®) protein and a porcine KLK1 (Kallidinogenase) protein have been approved in Asia for acute ischemic stroke, diabetic nephropathy, hypertension, and retinopathy. DiaMedica estimates over 200,000 patients are treated each year with the two forms of the KLK1 protein in Asia with total estimated sales of over $200 million U.S. About DiaMedica Therapeutics Inc. DiaMedica Therapeutics is a clinical stage biopharmaceutical company focused on developing novel treatments for neurological and kidney diseases. DiaMedica's shares are listed on the TSX Venture Exchange under the trading symbol "DMA" and on the OTCQB under the trading symbol "DMCAF". For more information, please visit www.diamedica.com. |
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