Annual report pursuant to Section 13 and 15(d)

Note 2 - Risks and Uncertainties

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Note 2 - Risks and Uncertainties
12 Months Ended
Dec. 31, 2018
Notes to Financial Statements  
Risks and Uncertainties [Text Block]
2.
 
Risks and Uncertainties
 
DiaMedica is subject to many risks and uncertainties. We are in the clinical stage of development of our initial product candidate,
DM199,
for the treatment of chronic kidney disease and acute ischemic stroke. The Company has
not
completed the development of any product candidate and, accordingly, has
not
begun to commercialize any product candidate or generate any revenues from the sale of any product candidate.
DM199
requires significant additional clinical testing and investment prior to seeking marketing approval and is
not
expected to be commercially available for several 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
DM199
product candidate in the United States or other markets, its ability to obtain required governmental approvals of its product candidate and ultimately its ability to license or market and sell its
DM199
product candidate, and its ability to obtain additional financing to fund these efforts.
 
As of
December 31, 2018,
we have incurred losses of
$46.0
million since our inception in
2000.
For the year ended
December 31, 2018,
we incurred a net loss of
$5.7
 million and negative cash flows from operating activities of
$5.7
 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 increase in the near term as we continue 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
2019
compared to
2018
as a result of our recently obtained Nasdaq-listed U.S. public reporting company status. As of
December 31, 2018,
DiaMedica had cash of
$16.8
million, working capital of
$16.7
million and shareholders’ equity of
$17.0
million. Our principal sources of cash have included net proceeds from the issuance of equity securities, including most recently an initial public offering of our common shares in the United States in
December 2018.
See Note
8
titled “Shareholders’ Equity” for additional information. Although the Company has previously been successful in obtaining financing through equity securities offerings, there is
no
assurance that we will be able to do so in the future. This is particularly true if our clinical data is
not
positive or economic and market conditions deteriorate.
 
Despite our recent initial public offering in the United States, 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,
DM199,
or any future product candidates, to a point where they
may
be commercially sold. We expect our current cash, which includes the net proceeds of our recent initial public offering, to be sufficient to allow us to complete our currently ongoing Phase II Remedy trial in patients with AIS, our Phase Ib trial in patients with CKD and a planned Phase II study in patients with CKD caused by rare diseases and to otherwise fund our planned operations through
2020.
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
may
require significant additional funds earlier than we currently expect and there is
no
assurance that we will
not
need or seek additional funding prior to such time.