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<p style="font-family:'Times New Roman', Times, serif;font-size:12pt;margin:0pt;text-align:center;text-transform:uppercase;"><b>UNITED STATES</b></p>

<p style="font-family:'Times New Roman', Times, serif;font-size:12pt;margin:0pt;text-align:center;text-transform:uppercase;"><b>SECURITIES AND EXCHANGE COMMISSION</b></p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><b>Washington, D.C. 20549</b></p>

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<p style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:18pt;margin:0pt;text-align:center;text-transform:uppercase;"><b>FORM 8-K</b></p>

<p style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;text-transform:uppercase;"><b>CURRENT REPORT</b></p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><b>Pursuant to Section 13 or 15(d) of </b><b>T</b><b>he Securities Exchange Act of 1934</b></p>

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<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;">Date of Report (Date of earliest event reported): <b>June </b><b>19</b><b>, 2019</b></p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;text-transform:uppercase;">&nbsp;</p>

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<p style="font-family:'Times New Roman', Times, serif;font-size:18pt;margin:0pt;text-align:center;text-transform:uppercase;"><b>diamedica therapeutics inc.</b></p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;">(Exact name of registrant as specified in its charter)</p>

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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><b>British Columbia</b></p>
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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><b>001-36291</b></p>
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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><b>Not Applicable</b></p>
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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;">(State or other jurisdiction of incorporation)</p>
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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;">(Commission File Number)</p>
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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;">(IRS Employer</p>

			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;">Identification No.)</p>
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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><b>2 Carlson Parkway, Suite 260</b></p>

			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><b>Minneapolis, Minnesota </b></p>
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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><b>&nbsp;</b></p>

			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><b>55447</b></p>
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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;">(Address of principal executive offices)</p>
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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;">(Zip Code)</p>
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<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;text-transform:uppercase;"><b>&nbsp;</b><b>(763) 496-5454</b></p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;">(Registrant&#8217;s telephone number, including area code)</p>

<p style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><b>Not Applicable</b></p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;">(Former name or former address, if changed since last report)</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin-bottom:0pt;margin-left:0pt;margin-top:0pt;text-align:center;">&nbsp;</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin-bottom:0pt;margin-left:0pt;margin-top:0pt;text-align:justify;">Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin-bottom:0pt;margin-left:0pt;margin-top:0pt;text-align:justify;">&nbsp;</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin-bottom:0pt;margin-left:0pt;margin-top:0pt;text-align:justify;">&#9744;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)</p>

<p style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin-bottom:0pt;margin-left:0pt;margin-top:0pt;text-align:justify;">&#9744;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)</p>

<p style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin-bottom:0pt;margin-left:0pt;margin-top:0pt;text-align:justify;">&#9744;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))</p>

<p style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin-bottom:0pt;margin-left:0pt;margin-top:0pt;text-align:justify;">&#9744;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))</p>

<p style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Securities registered pursuant to Section 12(b) of the Act:</p>

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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><b>&nbsp;</b></p>

			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><b>Title of each class</b></p>
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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><b>&nbsp;</b></p>

			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><b>Trading Symbol(s)</b></p>
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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><b>Name of each exchange on </b></p>

			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><b>which registered</b></p>
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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;">Voting common shares, no par value per share</p>
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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;">DMAC</p>
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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;">The Nasdaq Stock Market LLC</p>
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<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin-bottom:0pt;margin-left:0pt;margin-top:0pt;text-align:justify;">&nbsp;</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin-bottom:0pt;margin-left:0pt;margin-top:0pt;text-align:justify;">Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (&#167;230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (&#167;240.12b-2 of this chapter).</p>

<p style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt; text-align: right;">Emerging growth company &#9746;</p>

<p style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin-bottom:0pt;margin-left:0pt;margin-top:0pt;text-align:left;">If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. &#9746;</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;"><b>&nbsp;</b></p>

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			<p style="font-family:'Times New Roman', Times, serif;margin-right:0pt;margin-top:0pt;text-align:left;margin-bottom:0pt;font-size:10pt;"><b>Item 7.01.</b></p>
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			<p style="font-family:'Times New Roman', Times, serif;margin-right:0pt;margin-top:0pt;text-align:left;margin-bottom:0pt;font-size:10pt;"><b>Regulation FD Disclosure.</b></p>
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<p style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">On June 19, 2019, DiaMedica Therapeutics Inc. (the &#8220;Company&#8221;) announced interim results of the Phase 1b study from 28 evaluable participants with moderate and severe chronic kidney disease (&#8220;CKD&#8221;) as described in more detail under Item 8.01 of this Current Report on Form 8-K. A copy of the press release announcing the interim results is filed as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.</p>

<p style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Also on June 19, 2019, the Company made available an investor presentation in connection with its announcement of the interim results of the Phase 1b study from 28 evaluable participants with moderate and severe CKD. A copy of the investor presentation is furnished as Exhibit 99.2 to this Current Report on Form 8-K and incorporated herein by reference.</p>

<p style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">The information furnished under this Item 7.01 shall not be deemed &#8220;filed&#8221; for the purposes of Section 18 of the United States Securities Exchange Act of 1934, as amended (the &#8220;Exchange Act&#8221;), or otherwise subject to the liabilities of that section, and shall not be deemed incorporated by reference into any other filing by the Company under the Exchange Act or the United States Securities Act of 1933, as amended, except as otherwise expressly stated in such filing.</p>

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			<p style="font-family:'Times New Roman', Times, serif;margin-right:0pt;margin-top:0pt;text-align:left;margin-bottom:0pt;font-size:10pt;"><b>Item 8.01.</b></p>
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			<p style="font-family:'Times New Roman', Times, serif;margin-right:0pt;margin-top:0pt;text-align:left;margin-bottom:0pt;font-size:10pt;"><b>Other Events.</b></p>
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<p style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">On June 19, 2019, the Company announced interim results of the Phase 1b study from 28 evaluable participants with moderate and severe CKD. DM199 (recombinant KLK1) was observed in the study to be safe and well tolerated with no drug-related serious adverse events, consistent with earlier DM199 studies in healthy volunteers. The study also demonstrated a dose range which the Company believes will restore normal KLK1 levels in CKD patients. It is noteworthy that the pharmacokinetic (&#8220;PK&#8221;) profile in CKD subjects after dosing was similar to the PK profile in healthy volunteers. Encouraging early signals in estimated glomerular filtration rate, urinary albumin to creatinine ratio and other biomarkers were also observed in the study, which the Company believes show drug activity, consistent with the DM199 mechanism of action, and may represent initial proof-of-mechanism. The favorable interim safety, tolerability and PK data, complemented by pharmacodynamic observations, support the advancement of DM199 development to a Phase II clinical trial in patients with CKD.</p>

<p style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">A copy of the press release announcing the interim results is filed as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.</p>

<p style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</p>

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			<td style="width: 9%;"><b>Item 9.01&nbsp;</b></td>
			<td style="width: 91%;"><b>Financial Statements and Exhibits.</b></td>
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<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;text-indent:36pt;">(d)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<i>Exhibits</i>.</p>

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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><b>Exhibit No.</b></p>
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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><b>Description</b></p>
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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;">99.1</p>
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			<td style="vertical-align: top; width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td>
			<td style="vertical-align: top; width: 84%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">
			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;"><a href="ex_147963.htm" style="-sec-extract:exhibit;">Press Release dated June 19, 2019 announcing interim results of the Phase 1b trial of DM199 in chronic kidney disease participants (filed herewith)</a></p>
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			<td style="vertical-align: top; width: 15%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td>
			<td style="vertical-align: top; width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td>
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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;">99.2</p>
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			<td style="vertical-align: top; width: 1%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</td>
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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;"><a href="ex_147964.htm" style="-sec-extract:exhibit;">Investor Presentation issued by DiaMedica Therapeutics Inc. on June 19, 2019 (furnished herewith)</a></p>
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<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;"><b>&nbsp;</b></p>

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<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;text-transform:uppercase;"><b>SIGNATURE</b></p>

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<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;text-indent:36pt;">Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.</p>

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			<p style="margin-top: 0; margin-bottom: 0;"><b>DIAMEDICA THERAPEUTICS INC.</b></p>
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			<p style="margin-top: 0; margin-bottom: 0;"><font style="font-family: 'Times New Roman', Times, serif; font-size: 10pt">By: </font></p>
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			<p style="margin-top: 0; margin-bottom: 0;"><font style="font-family: 'Times New Roman', Times, serif; font-size: 10pt">/s/&nbsp;</font>Scott Kellen</p>
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			<p style="margin-top: 0; margin-bottom: 0;">Scott Kellen</p>
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			<p style="margin-top: 0; margin-bottom: 0;">Chief Financial Officer and Secretary</p>
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<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Dated: <b> </b>June 19, 2019</p>

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dmtp20190619_8k.htm
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
T
he Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
June
19
, 2019
diamedica therapeutics inc.
(Exact name of registrant as specified in its charter)
British Columbia
001-36291
Not Applicable
(State or other jurisdiction of incorporation)
(Commission File Number)
(IRS Employer
Identification No.)
2 Carlson Parkway, Suite 260
Minneapolis, Minnesota
55447
(Address of principal executive offices)
(Zip Code)
(763) 496-5454
(Registrant's telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐     Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐     Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐     Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐     Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on
which registered
Voting common shares, no par value per share
DMAC
The Nasdaq Stock Market LLC
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
Item 7.01.
Regulation FD Disclosure.
On June 19, 2019, DiaMedica Therapeutics Inc. (the "Company") announced interim results of the Phase 1b study from 28 evaluable participants with moderate and severe chronic kidney disease ("CKD") as described in more detail under Item 8.01 of this Current Report on Form 8-K. A copy of the press release announcing the interim results is filed as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.
Also on June 19, 2019, the Company made available an investor presentation in connection with its announcement of the interim results of the Phase 1b study from 28 evaluable participants with moderate and severe CKD. A copy of the investor presentation is furnished as Exhibit 99.2 to this Current Report on Form 8-K and incorporated herein by reference.
The information furnished under this Item 7.01 shall not be deemed "filed" for the purposes of Section 18 of the United States Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, and shall not be deemed incorporated by reference into any other filing by the Company under the Exchange Act or the United States Securities Act of 1933, as amended, except as otherwise expressly stated in such filing.
Item 8.01.
Other Events.
On June 19, 2019, the Company announced interim results of the Phase 1b study from 28 evaluable participants with moderate and severe CKD. DM199 (recombinant KLK1) was observed in the study to be safe and well tolerated with no drug-related serious adverse events, consistent with earlier DM199 studies in healthy volunteers. The study also demonstrated a dose range which the Company believes will restore normal KLK1 levels in CKD patients. It is noteworthy that the pharmacokinetic ("PK") profile in CKD subjects after dosing was similar to the PK profile in healthy volunteers. Encouraging early signals in estimated glomerular filtration rate, urinary albumin to creatinine ratio and other biomarkers were also observed in the study, which the Company believes show drug activity, consistent with the DM199 mechanism of action, and may represent initial proof-of-mechanism. The favorable interim safety, tolerability and PK data, complemented by pharmacodynamic observations, support the advancement of DM199 development to a Phase II clinical trial in patients with CKD.
A copy of the press release announcing the interim results is filed as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.
Item 9.01
Financial Statements and Exhibits.
(d)
Exhibits
.
Exhibit No.
Description
99.1
Press Release dated June 19, 2019 announcing interim results of the Phase 1b trial of DM199 in chronic kidney disease participants (filed herewith)
99.2
Investor Presentation issued by DiaMedica Therapeutics Inc. on June 19, 2019 (furnished herewith)
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
DIAMEDICA THERAPEUTICS INC.
By:
/s/
Scott Kellen
Scott Kellen
Chief Financial Officer and Secretary
Dated:
June 19, 2019