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 (“EMA”) in the European Union, and comparable agencies in other countries. As a result, DiaMedica is subject to many risks and uncertainties, including those described in the Company’s annual report on Form -K for the fiscal year ended under “.” We are in the clinical stage of development of our initial product candidate, for the treatment of CKD and AIS. 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 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 months 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 generate revenue sufficient to fund our continuing operations. For the foreseeable future, we expect to incur significant operating losses as we continue the research, development and clinical trials of, and to seek regulatory approval for, our product candidate. As of DiaMedica had cash and cash equivalents of million, marketable securities of million, working capital of million and shareholders’ equity of million. Our principal source of cash has been net proceeds from the issuance of equity securities. 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 anticipate that we will need substantial additional capital to further our research and development activities, complete the required clinical trials, fund our 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 resources to be sufficient to allow us to complete our current ongoing Phase II REMEDY trial in patients with AIS and the cohorts in the Phase II study in patients with CKD and to otherwise fund our planned operations into the quarter of However, the amount and timing of our future funding requirements will depend on many factors, including the timing and results of our ongoing development efforts, including enrollment in our clinical trials, 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.

 

The accompanying interim condensed consolidated financial statements have been prepared assuming that we will continue as a going concern which contemplates the realization of assets and liquidation of liabilities in the normal course of business and do include any adjustments relating to the recoverability or classification of assets or the amounts of liabilities that might result from the outcome of these uncertainties. Our ability to continue as a going concern, realize the carrying value of our assets and discharge our liabilities in the ordinary course of business is dependent upon a number of factors, including our ability to obtain additional financing, the success of our development efforts, our ability to obtain marketing approval for our initial product candidate, in the United States, the European Union or other markets, and ultimately our ability to license and/or market and sell our initial product candidate. These factors, among others, raise substantial doubt about our ability to continue operations as a going concern. See Note titled “Liquidity and Management’s Plans.”