DiaMedica operates in a highly regulated and competitive environment. The development, manufacturing and marketing of pharmaceutical products require approval from, and are subject to ongoing oversight by, the Food and Drug Administration (FDA) in the United States, the European Medicines Agency in the European Union and comparable agencies in other countries. We are in the clinical stage of development of our initial product candidate, for the treatment of AIS and CKD. The Company has completed the development of any product candidate and, accordingly, has begun to commercialize any product candidate or generate any revenues from the commercial sale of any product candidate. requires significant additional clinical testing and investment prior to seeking marketing approval and is expected to be commercially available for at least to years, if at all. The Company's future success is dependent upon the success of its development efforts, its ability to demonstrate clinical progress for its product candidate in the United States or other markets, its ability to obtain required governmental approvals of its product candidate, its ability to license or market and sell its product candidate and its ability to obtain additional financing to fund these efforts.

 

As of we have incurred losses of million since our inception in For the year ended we incurred a net loss of  million and negative cash flows from operating activities of million. We expect to continue to incur operating losses until such time as any future product sales, royalty payments, licensing fees and/or milestone payments are sufficient to generate revenue to fund our continuing operations. Further, we expect our operating losses to continue as we pursue the research, development and clinical trials of, and to seek regulatory approval for, our product candidate. In addition, we expect our operating expenses to increase in compared to to support our ongoing clinical and organizational development. As of we had cash, cash equivalents and short-term investments of million, working capital of million and shareholders' equity of million.

 

Our principal sources of cash have included net proceeds from the issuance of equity securities. See Note titled “Shareholders' Equity” for additional information. Although the Company has previously been successful in obtaining financing through equity securities offerings, there is assurance that we will be able to do so in the future. This is particularly true if our clinical data is positive or economic and market conditions deteriorate.

 

We expect that we will need substantial additional capital to further our research and development activities, complete the required clinical trials, regulatory activities and otherwise develop our product candidate or any future product candidates, to a point where they be commercially sold. We expect our current cash, cash equivalents and marketable securities, to be sufficient to allow us to complete our currently ongoing Phase study in patients with CKD and to otherwise fund our planned operations for at least the next months from the date of issuance of these financial statements. However, the amount and timing of our future funding requirements will depend on many factors, including the timing and results of ongoing development efforts, the potential expansion of current development programs, potential new development programs and related general and administrative support. We require significant additional funds earlier than we currently expect and there is assurance that we will need or seek additional funding prior to such time, especially if market conditions for raising additional capital are favorable.