MINNEAPOLIS--(BUSINESS WIRE)--DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, announced today the appointment of Dominic Cundari as Chief Commercial Officer. In this role, Mr. Cundari will be focused primarily on the commercial planning, positioning and launch preparations for DM199 in acute ischemic stroke.
“Dom has extensive experience in successfully launching specialty biopharmaceuticals and was instrumental in building the Activase® (tPA) franchise at Genentech and changing the standard of care for ischemic stroke patients,” said Rick Pauls, CEO of DiaMedica. “With his deep knowledge and passion for the acute ischemic stroke space, extensive key opinion leader relationships and strategic acumen, he is a welcome addition to our senior leadership team at this critical time in our development.”
“The majority of people who suffer from an acute ischemic stroke today miss the treatment window and are left without treatment options,” said Mr. Cundari. “When I saw the data for the KLK1 mechanism and DM199 specifically, I wanted to be a part of the team bringing this potentially life changing drug to stroke patients.”
Prior to joining DiaMedica, Mr. Cundari spent over twenty years launching innovative products and building and managing commercial organizations in multiple therapeutic areas at Genentech. He was most recently Senior Director of Genentech’s vascular franchise, where he managed the existing thrombolytic business, built the sales and marketing organizations for the launch of the blockbuster product Lucentis® and partnered with Actelion on launch readiness for Veletri®. Prior to this role, Mr. Cundari was Senior Director of Genentech’s cardiovascular franchise and Director of Cardiovascular sales. Earlier in his career, Mr. Cundari held multiple senior sales leadership roles in diverse therapeutic areas for Genentech and Ciba-Geigy. Mr. Cundari earned his B.S. and MS. Degrees in psychology from Villanova University.
Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)
In connection with Mr. Cundari’s appointment, the Company granted him two inducement stock options to purchase a total of 165,000 shares of DiaMedica’s common stock pursuant to the DiaMedica Therapeutics, Inc. 2021 Employment Inducement Incentive Plan. The inducement grants were approved by the Company’s compensation committee of the board of directors and were effective as of Mr. Cundari’s first date of employment, February 1, 2022, and were a material inducement to his acceptance of employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4) as a component of his compensation.
The stock options have an exercise price of $2.90 per share, which is equal to the closing price of DiaMedica’s common stock on the grant date and a 10-year term. The first option for 125,000 shares will vest over four years, with 25% of the shares underlying the option vesting on the one-year anniversary of the grant date, and the remaining shares vesting in equal amounts monthly over the remaining three years. The second option for 40,000 shares will vest quarterly over one year. These inducement grants are subject to the terms and conditions of award agreements and the plan under which they were granted.
About DM199
DM199 is a recombinant (synthetic) form of KLK1. KLK1 is a serine protease (protein) that 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 and prostaglandin. KLK1 deficiency may play a role in multiple vascular and fibrotic diseases such as stroke, chronic kidney disease, retinopathy, vascular dementia, and resistant hypertension where current treatment options are limited or ineffective. DiaMedica is the first company to have developed a recombinant form of the KLK1 protein. The KLK1 protein, produced from porcine pancreas and human urine, has been used to treat patients in Japan, China and South Korea for decades. DM199 is currently being studied in patients with acute ischemic stroke (AIS) and patients with chronic kidney disease. In September 2021, the FDA granted Fast Track Designation to DM199 for the treatment of AIS.
About DiaMedica Therapeutics Inc.
DiaMedica Therapeutics Inc. is a clinical stage biopharmaceutical company committed to improving the lives of people suffering from serious diseases. DiaMedica’s lead candidate DM199 is the first pharmaceutically active recombinant (synthetic) form of the KLK1 protein, an established therapeutic modality for the treatment of acute ischemic stroke and chronic kidney disease. For more information visit our website at www.diamedica.com.
Cautionary Note 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,” “continue,” “potential,” “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 benefits and success of DM199, including being a potentially life changing drug to stroke 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, the possibility of unfavorable results from DiaMedica’s ongoing or future clinical trials of DM199; the risk that existing preclinical and clinical data may not be predictive of the results of ongoing or later clinical trials; DiaMedica’s plans to develop, obtain regulatory approval for and commercialize its DM199 product candidate for the treatment of acute ischemic stroke and chronic kidney disease and its expectations regarding the benefits of DM199; DiaMedica’s ability to conduct successful clinical testing of DM199 and within its anticipated parameters, costs and timeframes; the perceived benefits of DM199 over existing treatment options; the potential direct or indirect impact of the COVID-19 pandemic on DiaMedica’s business; DiaMedica’s reliance on collaboration with third parties to conduct clinical trials; DiaMedica’s ability to continue to obtain funding for its operations, including funding necessary to complete planned clinical trials and obtain regulatory approvals for DM199 for acute ischemic stroke and chronic kidney disease, 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, 2020 and subsequent reports filed with the U.S. Securities and Exchange Commission. 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.
