DiaMedica Therapeutics Inc. (NASDAQ: DMAC)

DiaMedica Therapeutics Inc., a clinical-stage biopharmaceutical company that trades on the NASDAQ under the ticker symbol DM, is dedicated to improving the lives of individuals suffering from serious diseases. The company's primary focus is on the treatment of acute ischemic stroke (AIS) and cardio-renal disease (CRD) using its proprietary recombinant KLK1 technology. DiaMedica's lead candidate, DM199, is a recombinant form of the human tissue kallikrein-1 (KLK1) protein, which is the first pharmaceutically active form of KLK1 to be clinically studied in patients. KLK1 is an established therapeutic modality in Asia, with human urinary KLK1 being approved for the treatment of AIS and CRD, including hypertension.

DiaMedica's main business activities revolve around the development of DM199 for the treatment of AIS and CRD. The company's strategy is to develop a novel treatment that can fill the significant unmet medical need for patients who cannot receive tissue plasminogen activator (tPA) or mechanical thrombectomy. DM199 has the potential to provide a new treatment option for patients with AIS, particularly those who have a large vessel occlusion or are not eligible for tPA or mechanical thrombectomy. Additionally, DiaMedica is developing DM199 for the treatment of CRD, which is a complex interplay between cardiac and renal dysfunction. The company believes that DM199 has the potential to provide a new treatment option for patients with CRD, particularly those with hypertension.

The company generates revenue through the development and clinical testing of DM199. DiaMedica's primary products and services are DM199 for the treatment of AIS and CRD. The company's primary customer base includes patients with AIS and CRD who have limited treatment options. DiaMedica's competitive advantages include its proprietary recombinant KLK1 technology, which has the potential to overcome the regulatory and commercial drawbacks associated with KLK1 derived from human urine or porcine pancreas. Additionally, DiaMedica's DM199 has the potential to provide a new treatment option for patients with AIS and CRD, particularly those who have limited treatment options.

DiaMedica's customers include Techpool Bio-Pharma Inc., a company controlled by Shanghai Pharmaceuticals Holding Co. Ltd., which has approved and marketed Kailikang, a form of KLK1 derived from human urine, for the treatment of AIS in China. DiaMedica believes that over 600,000 stroke patients in China were treated with Kailikang in 2022.

In the context of AIS, the company's Phase 2 ReMEDy1 trial demonstrated a statistically significant reduction in the number of participants with recurrent ischemic stroke, and a 22% absolute improvement in excellent outcomes in patients not receiving mechanical thrombectomy prior to enrollment. The trial also showed a significant reduction in the number of participants with severe stroke recurrence, with 0 (0%) participants treated with DM199 experiencing severe stroke recurrence compared to 6 (13%) on placebo. In the context of CRD, the company's REDUX trial demonstrated clinically meaningful improvements in kidney function, as measured by simultaneously stabilizing estimated glomerular filtration rate (eGFR) and decreasing the urinary albumin-to-creatinine ratio (UACR). The trial also showed a significant reduction in blood pressure in hypertensive participants.

The company's DM199 has been generally safe and well-tolerated in clinical trials, with the most frequently reported treatment-emergent adverse events being constipation, oral candidiasis, and nausea. The side effect observed to limit participant tolerability was orthostatic hypotension, which has been primarily seen at doses 10 to 20 times higher than the anticipated therapeutic dose levels.

In the United States, the FDA is responsible for the drug approval process. The FDA's mission is to ensure that all medications on the market are safe and effective. The FDA's approval process examines and thoroughly reviews potential new drugs; only those that are in compliance with the Code of Regulations, 21 CFR 312 and 21 CFR 314 are approved. The company's DM199 may qualify for 12 years of data exclusivity under the Biologics Price Competition and Innovation Act of 2009 (BPCIA), as amended by the Health Care and Education Reconciliation Act of 2010. Under the BPCIA, an application for a biosimilar product (BLA) cannot be submitted to the FDA until four years, or if approved by the FDA, until 12 years, after the original brand product identified as the reference product is approved under a BLA.

The company's research and development expenses include expenses incurred with third-party service providers such as contract research organizations and other study support services, expenses incurred under agreements with clinical trial sites that conduct research activities on behalf of the company, laboratory and vendor expenses related to the execution of clinical trials and non-clinical studies, the cost of acquiring, developing, manufacturing, and distributing clinical trial materials, employee and consultant-related expenses, and facilities and other expenses. The company does not own or operate manufacturing facilities for the production of DM199 nor does it have plans to develop its own manufacturing operations in the foreseeable future. The company relies on Catalent Pharma Solutions, LLC (Catalent), a contract development and manufacturing organization (CDMO) with proven GMP experience in the manufacturing of recombinant proteins for clinical trials, for procuring all of its required raw materials and producing active pharmaceutical ingredient for its clinical trials.

The company's sales and marketing strategy has not yet been defined, but it is expected to partner with a large pharmaceutical company for sales execution. The company's intellectual property portfolio includes four granted U.S. patents, a granted European patent, a granted Canadian patent, and pending applications in Australia, Canada, China, Europe, India, Japan, South Korea, Hong Kong, and the United States. The granted or pending claims offer various forms of protection for DM199, including claims to compositions of matter, pharmaceutical compositions, specific formulations and dosing levels, and methods for treating a variety of diseases, including stroke, chronic kidney disease, and related disorders.