<SEC-DOCUMENT>0001437749-17-021316.txt : 20171229
<SEC-HEADER>0001437749-17-021316.hdr.sgml : 20171229
<ACCEPTANCE-DATETIME>20171229160116
ACCESSION NUMBER:		0001437749-17-021316
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20171227
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20171229
DATE AS OF CHANGE:		20171229

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Diffusion Pharmaceuticals Inc.
		CENTRAL INDEX KEY:			0001053691
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				300645032
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-37942
		FILM NUMBER:		171281975

	BUSINESS ADDRESS:	
		STREET 1:		2020 AVON COURT
		STREET 2:		SUITE 4
		CITY:			CHARLOTTESVILLE
		STATE:			VA
		ZIP:			22902
		BUSINESS PHONE:		(434) 220-0718

	MAIL ADDRESS:	
		STREET 1:		2020 AVON COURT
		STREET 2:		SUITE 4
		CITY:			CHARLOTTESVILLE
		STATE:			VA
		ZIP:			22902

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	RestorGenex Corp
		DATE OF NAME CHANGE:	20140307

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	Stratus Media Group, Inc
		DATE OF NAME CHANGE:	20080722

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	FERIS INTERNATIONAL, INC.
		DATE OF NAME CHANGE:	20080228
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>dffn20171228_8k.htm
<DESCRIPTION>FORM 8-K
<TEXT>
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<p style="font-family: Times New Roman; font-size: 16pt; margin: 0pt; text-align: center; text-transform: uppercase;"><b>UNITED STATES</b></p>

<p style="font-family: Times New Roman; font-size: 16pt; margin: 0pt; text-align: center; text-transform: uppercase;"><b>SECURITIES AND EXCHANGE COMMISSION</b></p>

<p style="font-family: Times New Roman; font-size: 12pt; margin: 0pt; text-align: center;"><b>Washington, D.C. 20549</b></p>

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

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

<p style="font-family: Times New Roman; font-size: 12pt; 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></p>

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:center;"><b>the Securities Exchange Act of 1934</b></p>

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

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:center;"><b>Date of Report (Date of earliest event reported): </b><font style="font-family:Times New Roman, Times, serif;font-size:10pt;"><b>December 27</b><b>, 2017</b></font></p>

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:center;text-transform:uppercase;">___________________</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:18pt;margin:0pt;text-align:center;"><b>DIFFUSION PHARMACEUTICALS 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>

<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="vertical-align: top; width: 33%;">
			<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:center;"><b>000-24477</b></p>
			</td>
			<td style="vertical-align: top; width: 33%;">
			<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:center;"><b>30-0645032</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</p>

			<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:center;">incorporation)</p>
			</td>
			<td style="vertical-align: top; width: 33%;">
			<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:center;">(Commission File</p>

			<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:center;">Number)</p>
			</td>
			<td style="vertical-align: top; width: 33%;">
			<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:center;">(I.R.S. Employer</p>

			<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:center;">Identification No.)</p>
			</td>
		</tr>

</table>

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:center;text-indent:42.5pt;">&nbsp;</p>

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			<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:center;"><b>1317 Carlton Avenue, Suite 400</b></p>

			<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:center;"><b>Charlottesville, Virginia</b></p>
			</td>
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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>22902</b></p>
			</td>
		</tr>
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			<td style="vertical-align:top;width:50%;">
			<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:center;">(Address of principal executive offices)</p>
			</td>
			<td style="vertical-align:top;width:50%;">
			<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;">&nbsp;</p>

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:center;"><b>(434) 220-0718</b></p>

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:center;">(Registrant<font style="font-family:Times New Roman, Times, serif;font-size:10pt;">&rsquo;s telephone number, including area code)</font></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>N/A</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-top: 0pt; margin-bottom: 0pt;">&nbsp;</p>

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

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			<p style="margin: 0pt; text-align: justify; font-size: 10pt; font-family: Times New Roman, Times, serif;">&#9744;<font style="font-family:Times New Roman, Times, serif;font-size:10pt;"> </font></p>
			</td>
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			<p style="margin: 0pt; text-align: justify; font-size: 10pt; font-family: Times New Roman, Times, serif;"><font style="font-family:Times New Roman, Times, serif;font-size:10pt;">Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)</font></p>
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			<p style="margin: 0pt; text-align: justify; font-size: 10pt; font-family: Times New Roman, Times, serif;">&#9744;<font style="font-family:Times New Roman, Times, serif;font-size:10pt;"> </font></p>
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			<p style="margin: 0pt; text-align: justify; font-size: 10pt; font-family: Times New Roman, Times, serif;"><font style="font-family:Times New Roman, Times, serif;font-size:10pt;">Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)</font></p>
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			<p style="margin: 0pt; text-align: justify; font-size: 10pt; font-family: Times New Roman, Times, serif;">&#9744;<font style="font-family:Times New Roman, Times, serif;font-size:10pt;"> </font></p>
			</td>
			<td>
			<p style="margin: 0pt; text-align: justify; font-size: 10pt; font-family: Times New Roman, Times, serif;"><font style="font-family:Times New Roman, Times, serif;font-size:10pt;">Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))</font></p>
			</td>
		</tr>

</table>

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			<td style="width: 18pt;">
			<p style="margin: 0pt; text-align: justify; font-size: 10pt; font-family: Times New Roman, Times, serif;">&#9744;<font style="font-family:Times New Roman, Times, serif;font-size:10pt;"> </font></p>
			</td>
			<td>
			<p style="margin: 0pt; text-align: justify; font-size: 10pt; font-family: Times New Roman, Times, serif;"><font style="font-family:Times New Roman, Times, serif;font-size:10pt;">Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))</font></p>
			</td>
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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;"><b>Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (&sect;&thinsp;230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (&sect;&thinsp;240.12b-2 of this chapter).</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:justify;"><b>Emerging growth company<font style="font-family:Times New Roman, Times, serif;font-size:10pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</font></b><font style="font-family:Times New Roman, Times, serif;font-size:10pt;">&#9744;</font></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;"><b>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.<font style="font-family:Times New Roman, Times, serif;font-size:10pt;">&nbsp;</font></b><font style="font-family:Times New Roman, Times, serif;font-size:10pt;">&#9744;</font></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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<div id="PGNUM" style="text-align: center; width: 100%">&nbsp;</div>

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

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			<p style="margin: 0pt; text-align: justify; font-size: 10pt; font-family: Times New Roman, Times, serif;"><b>Item 8</b><font style="font-family:Times New Roman, Times, serif;font-size:10pt;"><b>.0</b><b>1</b><b>. </b></font></p>
			</td>
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			<p style="margin: 0pt; text-align: justify; font-size: 10pt; font-family: Times New Roman, Times, serif;"><font style="font-family:Times New Roman, Times, serif;font-size:10pt;"><b>Other Events</b><b>.</b></font></p>
			</td>
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<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><b>&nbsp;</b></p>

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;">On December 27<font style="font-family:Times New Roman, Times, serif;font-size:10pt;">, 2017, Diffusion Pharmaceuticals Inc. issued a press release announcing that its Phase 3 clinical trial using its lead small molecule trans sodium crocetinate in patients with newly-diagnosed inoperable glioblastoma multiforme brain cancer is now open for enrollment. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.</font></p>

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

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			<p style="margin: 0pt; text-align: justify; font-size: 10pt; font-family: Times New Roman, Times, serif;"><b>Item 9.01<font style="font-family:Times New Roman, Times, serif;font-size:10pt;"> </font></b></p>
			</td>
			<td>
			<p style="margin: 0pt; text-align: justify; font-size: 10pt; font-family: Times New Roman, Times, serif;"><b><font style="font-family:Times New Roman, Times, serif;font-size:10pt;">Financial Statements and Exhibits. </font></b></p>
			</td>
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</table>

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

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;">&nbsp;<font style="font-family:Times New Roman, Times, serif;font-size:10pt;">&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;Exhibits. </font></p>

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

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			<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><u>Exhibit Number</u></p>
			</td>
			<td style="vertical-align: top; width: 80%;">
			<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><u>Description</u></p>
			</td>
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			<td style="vertical-align: top; width: 20%;">&nbsp;</td>
			<td style="vertical-align: top; width: 80%;">&nbsp;</td>
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			<td style="vertical-align: top; width: 20%;">
			<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;">99.1</p>
			</td>
			<td style="vertical-align: top; width: 80%;">
			<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><a href="ex_102537.htm" style="-sec-extract:exhibit;">Press Release dated December 27, 2017</a></p>
			</td>
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<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><i>&nbsp;</i></p>

<div id="PGBK" style="width: 100%; margin-left: 0pt; margin-right: 0pt">
<div id="PGNUM" style="text-align: center; width: 100%">&nbsp;</div>

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

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

<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, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.</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: 46%;" valign="top" width="50%">Dated: <font style="font-family:Times New Roman, Times, serif;font-size:10pt;">December 29, 2017</font></td>
			<td colspan="2" style="width: 3%;" valign="top" width="38%"><font style="font-family:Times New Roman, Times, serif;font-size:10pt;"><b>DIFFUSION PHARMACEUTICALS INC.</b></font></td>
			<td style="width: 16%;" valign="top" width="12%">
			<p style="margin-top: 0; margin-bottom: 0;"><font style="FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">&nbsp;</font></p>
			</td>
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			<p style="margin-top: 0; margin-bottom: 0;"><font style="FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">&nbsp;</font></p>
			</td>
			<td style="width: 3%;" valign="top" width="3%">
			<p style="margin-top: 0; margin-bottom: 0;"><font style="FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">&nbsp;</font></p>
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			<td style="width: 35%;" valign="top" width="35%">
			<p style="margin-top: 0; margin-bottom: 0;"><font style="FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">&nbsp;</font></p>
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			<td style="width: 16%;" valign="top" width="12%">
			<p style="margin-top: 0; margin-bottom: 0;"><font style="FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">&nbsp;</font></p>
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			<p style="margin-top: 0; margin-bottom: 0;"><font style="FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">&nbsp;</font></p>
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			<p style="margin-top: 0; margin-bottom: 0;"><font style="FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">&nbsp;</font></p>
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			<td align="left" nowrap="nowrap" style="width: 35%;" valign="bottom" width="35%">
			<p style="margin-top: 0; margin-bottom: 0;"><font style="FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">&nbsp;</font></p>
			</td>
			<td style="width: 16%;" valign="top" width="12%">
			<p style="margin-top: 0; margin-bottom: 0;"><font style="FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">&nbsp;</font></p>
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			<p style="margin-top: 0; margin-bottom: 0;"><font style="FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">&nbsp;</font></p>
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			<p style="margin-top: 0; margin-bottom: 0;"><font style="FONT-FAMILY: Times New Roman; 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; FONT-SIZE: 10pt">&nbsp;&nbsp;&nbsp; /s/&nbsp;</font><font style="font-family:Times New Roman, Times, serif;font-size:10pt;">David G. Kalergis</font></p>
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			<p style="margin-top: 0; margin-bottom: 0;"><font style="FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">&nbsp;</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;">Name: David G. Kalergis</font></p>
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			<p style="margin-top: 0; margin-bottom: 0;"><font style="FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">&nbsp;</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;">Title:&nbsp;&nbsp; Chief Executive Officer</font></p>
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<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>ex_102537.htm
<DESCRIPTION>EXHIBIT 99.1
<TEXT>
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<p style="margin-bottom: 0px; text-align: right; margin-top: 0px"><font style="font-size: 10pt; font-family: Times New Roman, Times, serif"><b>Exhibit 99.1</b></font></p>

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

<p style="font-family: Times New Roman, Times, serif; font-size: 10pt; margin: 0pt 0pt 0pt -9pt; text-align: left;"><img src="ex_102537img001.jpg" style="width: 133pt; height: 56pt;"></p>

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

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

<p style="font-family:Times New Roman, Times, serif;font-size:12pt;margin-bottom:0pt;margin-left:4.5pt;margin-right:0pt;margin-top:0pt;text-align:center;text-indent:4.5pt;"><b>Diffusion Pharmaceuticals </b><font style="font-family:Times New Roman, Times, serif;font-size:12pt;"><b>Begins</b><b> Phase 3 Clinical Trial </b><b>with </b><b>TSC </b><b>in Glioblastoma Multiforme</b></font></p>

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin-bottom:0pt;margin-left:4.5pt;margin-right:0pt;margin-top:0pt;text-align:center;text-indent:4.5pt;"><b>&nbsp;</b></p>

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin-bottom:0pt;margin-left:4.5pt;margin-right:0pt;margin-top:0pt;text-align:center;text-indent:4.5pt;"><i>Trial in n</i><font style="font-family:Times New Roman, Times, serif;font-size:10pt;"><i>ewly diagnosed inoperable p</i><i>atients </i><i>now </i><i>open</i><i> for enrollment</i></font></p>

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

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><b>CHARLOTTESVILLE</b><font style="font-family:Times New Roman, Times, serif;font-size:10pt;"><b>, </b><b>Va. </b><b>(</b><b>December</b><b> </b><b>27</b><b>,</b><b> 201</b><b>7</b><b>)</b> &ndash; <b>Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN)</b> (&ldquo;Diffusion&rdquo; or &ldquo;the Company&rdquo;), a clinical-stage biotechnology company focused on extending the life expectancy of cancer patients, today announced that a Phase 3 clinical trial using its lead small molecule trans sodium crocetinate (&ldquo;TSC&rdquo;) in patients with newly-diagnosed inoperable glioblastoma multiforme (&ldquo;GBM&rdquo;) brain cancer, is now open for enrollment. The trial, which has been named INTACT (<b>IN</b>vestigating <b>T</b>sc <b>A</b>gainst <b>C</b>ancerous <b>T</b>umors), follows a previous Phase 2 GBM study in which the inoperable patient subgroup showed a nearly four-fold increase in survival compared with historical controls when TSC was added to their treatment regimen (40% alive at two years vs. 10.4%). TSC&rsquo;s innovative mechanism of action affects the tumor micro-environment, making treatment-resistant cancer cells more susceptible to the tumor-killing power of conventional radiation therapy (&ldquo;RT&rdquo;) and chemotherapy (temozolomide) by re-oxygenation of the hypoxic portion of the tumor. The Company believes that a largely intact GBM tumor vasculature with limited surgical resection is conducive to TSC&rsquo;s tumor re-oxygenation properties, and that this contributed to the survival increase in the Phase 2 GBM inoperable patient subgroup.</font></p>

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

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;">T<font style="font-family:Times New Roman, Times, serif;font-size:10pt;">he trial will screen 300 patients and enroll 264 in an effort to ensure that results from 236 patients will be available for analysis. Enrolled patients will be randomized in a 1:1 ratio into treatment and control groups. Patients in the treatment group will receive standard of care (&ldquo;SOC&rdquo;) temozolomide and RT plus an intravenous bolus of TSC administered shortly before their SOC treatments. Patients in the control group will receive SOC alone. The study will compare overall survival at two years between patients in the two groups. Up to 100 clinical sites in the U.S. and Europe are expected to participate. The Company projects that enrollment will be completed by early 2019, with interim safety and efficacy data possible in 2020 and trial completion in 2021. Further site initiation is on-going, with first patient enrollment targeted for January 2018.</font></p>

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

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;">&ldquo;Given the dire prognosis of inoperable GBM brain cancer, we are especially gratified to <font style="font-family:Times New Roman, Times, serif;font-size:10pt;">have the INTACT clinical trial open for enrollment. We believe that TSC can provide new hope for these patients, whose treatment options are so limited,&rdquo; said David Kalergis, Chief Executive Officer of Diffusion Pharmaceuticals. &ldquo;The four-fold increase in inoperable GBM patients alive at two years in our Phase 2 trial is a particularly strong efficacy signal, and informs the design of our Phase 3 trial.&rdquo; </font></p>

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

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

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><b>About the </b><font style="font-family:Times New Roman, Times, serif;font-size:10pt;"><b>GBM </b><b>Phase 3 </b><b>INTACT </b><b>Trial</b></font></p>

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

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;">The INTACT <font style="font-family:Times New Roman, Times, serif;font-size:10pt;">clinical trial is an open-label, randomized, controlled, Phase 3 safety and efficacy registration trial. Subjects will be randomized at baseline to SOC for first-line treatment of GBM plus TSC, or to SOC alone. The SOC for GBM is temozolomide plus RT for 6 weeks followed by 28 days of rest, followed by 6 cycles of post-radiation temozolomide treatment.</font></p>

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

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

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;">TSC will be administered during both the RT and post-radiation temozolomide treatment periods to those subjects so randomized.</p>

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

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;">During the RT treatment period subjects will receive:</p>

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			<td style="width:18pt;">&nbsp;</td>
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			<p style="font-family:Times New Roman, Times, serif;margin-right:0pt;margin-top:0pt;text-align:justify;margin-bottom:0pt;font-size:10pt;">o</p>
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			<p style="font-family:Times New Roman, Times, serif;margin-right:0pt;margin-top:0pt;text-align:justify;margin-bottom:0pt;font-size:10pt;">Focal RT delivered as 60Gy/30 fractions scheduled at 2Gy/day for 5 days each week (Monday through Friday) for 6 weeks.</p>
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			<td style="width:18pt;">&nbsp;</td>
			<td style="width:18pt;vertical-align:top;">
			<p style="font-family:Times New Roman, Times, serif;margin-right:0pt;margin-top:0pt;text-align:justify;margin-bottom:0pt;font-size:10pt;">o</p>
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			<p style="font-family:Times New Roman, Times, serif;margin-right:0pt;margin-top:0pt;text-align:justify;margin-bottom:0pt;font-size:10pt;">Temozolomide 75 mg/m<font style="font-size:10pt;font-family:Times New Roman, Times, serif;"><sup>2 </sup>orally<sup> </sup>once daily (usually administered the night preceding each RT session) starting the evening before the first RT session over a period of 42 calendar days with a maximum of 49 days.</font></p>
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			<td style="width:18pt;">&nbsp;</td>
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			<p style="font-family:Times New Roman, Times, serif;margin-right:0pt;margin-top:0pt;text-align:justify;margin-bottom:0pt;font-size:10pt;">o</p>
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			<p style="font-family:Times New Roman, Times, serif;margin-right:0pt;margin-top:0pt;text-align:justify;margin-bottom:0pt;font-size:10pt;">TSC 0.25<font style="font-size:10pt;font-family:Times New Roman, Times, serif;"> mg/kg IV for 3 days each week (e.g., Monday, Wednesday, Friday, or other schedule that supplies a minimum 3 TSC doses per week) administered between 45 to 60 minutes prior to each RT session. </font></p>
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<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;">&nbsp;</p>

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;">During the 28-day rest period all subjects will receive no treatment.</p>

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

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;">During the post-radiation 6-cycle temozolomide treatment period:</p>

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			<p style="font-family:Times New Roman, Times, serif;margin-right:0pt;margin-top:0pt;text-align:justify;margin-bottom:0pt;font-size:10pt;">o</p>
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			<p style="font-family:Times New Roman, Times, serif;margin-right:0pt;margin-top:0pt;text-align:justify;margin-bottom:0pt;font-size:10pt;">All subjects will receive<font style="font-size:10pt;font-family:Times New Roman, Times, serif;"> 28-day oral temozolomide (150 mg/m<sup>2</sup> first cycle and 200 mg/m<sup>2</sup> all subsequent cycles as tolerated) administered on Day 1-5 (Monday through Friday) of each 28-day cycle.</font></p>
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			<td style="width:18pt;">&nbsp;</td>
			<td style="width:18pt;vertical-align:top;">
			<p style="font-family:Times New Roman, Times, serif;margin-right:0pt;margin-top:0pt;text-align:justify;margin-bottom:0pt;font-size:10pt;">o</p>
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			<p style="font-family:Times New Roman, Times, serif;margin-right:0pt;margin-top:0pt;text-align:justify;margin-bottom:0pt;font-size:10pt;">Controls<font style="font-size:10pt;font-family:Times New Roman, Times, serif;"> will receive oral temozolomide at night at home per the SOC and are not required to attend clinic visits during this period.</font></p>
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			<td style="width:18pt;">&nbsp;</td>
			<td style="width:18pt;vertical-align:top;">
			<p style="font-family:Times New Roman, Times, serif;margin-right:0pt;margin-top:0pt;text-align:justify;margin-bottom:0pt;font-size:10pt;">o</p>
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			<td style="vertical-align:top;">
			<p style="font-family:Times New Roman, Times, serif;margin-right:0pt;margin-top:0pt;text-align:justify;margin-bottom:0pt;font-size:10pt;">Subjects randomized to TSC will receive TSC 1.5 mg/kg (or another dose if recommended by the DSMB) 1.5 to 2 hours before their temozolomide dose during the daytime for 3 days during the first week of each 28-day cycle (Days 1, 3, <font style="font-size:10pt;font-family:Times New Roman, Times, serif;">and 5; e.g., Monday, Wednesday, Friday or other schedule that supplies at minimum 3 TSC doses per week).&nbsp; The Tuesday, Thursday doses will be given at night at home.&nbsp; Long-acting antiemetics may be administered prior to daytime temozolomide dosing on Days 1, 3, 5.</font></p>
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<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;">&nbsp;</p>

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;">The safety, tolerability and<font style="font-family:Times New Roman, Times, serif;font-size:10pt;"> pharmacokinetics (&ldquo;PK&rdquo;) of TSC at higher doses than 0.25 mg/kg with temozolomide will be assessed during adjuvant therapy. TSC at doses between 0.25 mg/kg and up to 1.5 mg/kg in combination with concomitant temozolomide will be assigned (not randomized) in the first 8 subjects enrolled in the INTACT trial. These patients will undergo RT plus temozolomide plus TSC treatment (0.25 mg/kg) for 6 weekly cycles followed by 4 weeks of rest in standard fashion. At the Week 10 clinic visit the same 8 subjects will be assigned to treatment, with 2 subjects each assigned to TSC at doses of 0.25, 0.50, 1.0, and 1.5 mg/kg.&nbsp; These subjects will be studied in parallel for 2 28-day cycles with inclusion of appropriate blood sampling collection for TSC and temozolomide PK. The Data Safety Monitoring Board (&ldquo;DSMB&rdquo;) will examine the resultant safety data after 2 cycles (Weeks 11 through 18 of post-radiation temozolomide treatment period; Days 1 to 56). The DSMB may recommend continued use of the 1.5 mg/kg TSC dose for the post-radiation temozolomide treatment period, or may prescribe another dose based on their observations. Subjects then entering into the INTACT trial will be randomized at baseline between TSC plus SOC, or SOC alone.</font></p>

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

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;">F<font style="font-family:Times New Roman, Times, serif;font-size:10pt;">urther details about the trial protocol will be available shortly at <u>www.clinicaltrials.gov</u>.</font></p>

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

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;">The baseline assessment for determining <font style="font-family:Times New Roman, Times, serif;font-size:10pt;">progression-free survival (&ldquo;PFS&rdquo;), overall response rate (&ldquo;ORR&rdquo;) and to rule out pseudo-progression, will be at 10 weeks via MRI using the &ldquo;modified Response Assessment in Neuro-Oncology&rdquo;&nbsp;(&ldquo;mRANO&rdquo;) scale. The hazard ratio for the trial will be 0.67, which corresponds to 22% two-year survival in the TSC arm, the lower limit of the 95% confidence interval for the biopsy-only subjects in Diffusion&rsquo;s Phase 2 trial, and 10% survival in the SOC arm. The estimated median survival is therefore 10 months for the SOC arm vs. 14.9 months for the TSC plus SOC arm. In order to achieve 80% power, the trial requires 118 subjects in each arm. </font></p>

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

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;">The study <font style="font-family:Times New Roman, Times, serif;font-size:10pt;">will achieve the designed 80% statistical power at 198 events, where an event is defined as death. The first analysis will occur at the earlier of two years follow-up for all subjects or 198 events. If the first analysis is at 198 events, the analysis will be a standard 2-sided stratified log-rank test at the </font><font style="font-family:Times New Roman, Times, serif;font-size:10pt;">&alpha;=0.05 significance level. If the first analysis is at two years, the Company will perform the analysis using the O&rsquo;Brien-Fleming Method. </font></p>

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

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

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><b>About Treatment-Resistant Cancers and TSC</b></p>

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

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Oxygen deprivation at the cellular level (hypoxia) is the result of rapid tumor growth, causing the tumor to outgrow its blood supply.<font style="font-family:Times New Roman, Times, serif;font-size:10pt;">&nbsp;Cancerous tumor cells thrive with hypoxia and the resultant changes in the tumor microenvironment cause the tumor to become resistant to RT and chemotherapy.&nbsp; Using a novel, proprietary mechanism of action, Diffusion&rsquo;s lead drug TSC appears to counteract tumor hypoxia &ndash; and therefore treatment resistance &ndash; by safely re-oxygenating tumor tissue, thus enhancing tumor kill and potentially prolonging patient life expectancy.&nbsp;Oxygen levels of normal tissue appear to remain unaffected upon administration of TSC.</font></p>

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

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><b>About Diffusion Pharmaceuticals Inc.</b></p>

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

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Diffusion Pharmaceuticals Inc. is a clinical<font style="font-family:Times New Roman, Times, serif;font-size:10pt;">-stage biotechnology company focused on extending the life expectancy of cancer patients by improving the effectiveness of current standard-of-care (SOC) treatments including radiation therapy and chemotherapy. Diffusion is developing its lead product candidate, trans sodium crocetinate (TSC), for use in cancers where tumor hypoxia (oxygen deprivation) diminishes the effectiveness of SOC treatments. TSC targets the cancer&#39;s hypoxic micro-environment, re-oxygenating treatment-resistant tissue and making the cancer cells more vulnerable to the therapeutic effects of SOC treatments without the apparent addition of any serious side effects.</font></p>

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

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;">A Phase 3 randomized, controlled registration trial with TSC and SOC chemotherapy and radiation compared with SOC alone in 236 newly diagnosed and inoperable glioblastoma multiforme <font style="font-family:Times New Roman, Times, serif;font-size:10pt;">patients, is now open for enrollment. The trial, which has been named INTACT (<b>IN</b>vestigating <b>T</b>sc <b>A</b>gainst <b>C</b>ancerous <b>T</b>umors), was preceded by a Phase 2 clinical program completed in the fourth quarter of 2015 that evaluated 59 patients with newly-diagnosed glioblastoma multiforme, a type of brain cancer. This open-label, historically controlled study demonstrated a favorable safety and efficacy profile for TSC combined with SOC, including a 36% improvement in overall survival compared with the control group at two years. A strong efficacy signal was seen in the subset of inoperable patients where survival of TSC-treated patients at two years was nearly four-fold higher compared with the controls. </font></p>

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

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Due to its novel mechanism of action, TSC has safely re<font style="font-family:Times New Roman, Times, serif;font-size:10pt;">-oxygenated a range of tumor types in preclinical and clinical studies. Diffusion believes its therapeutic potential is not limited to one specific tumor type, thereby making it potentially useful to improve SOC treatments of other life-threatening cancers. Given TSC&#39;s safety profile and animal data, Diffusion believes that, with appropriate funding support, it can move directly into Phase 2 studies in other cancers. The Company also believes that TSC has potential application in other indications involving hypoxia, such as neurodegenerative diseases and emergency medicine. For example, a stroke program is now under discussion with doctors from the University of California in Los Angeles, the University of Southern California, and the University of Virginia, with whom Diffusion has established a joint team developing a program to test TSC, with an in-ambulance trial of TSC in ischemic and hemorrhagic stroke under consideration. Planning for such a trial is ongoing.</font></p>

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

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

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><b>Forward-Looking Statements</b></p>

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

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;">To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the company&#39;s plans, objectives, expectations and intentions with respect to future operations and products, the potential of the company&#39;s technology and product candidates, the anticipated timing of future clinical trials and protocol review, and other statements that are not historical in nature, particularly those that utilize terminology such as &quot;would,&quot; &quot;will,&quot; &quot;plans,&quot; &quot;possibility,&quot; &quot;potential,&quot; &quot;future,&quot; &quot;expects,&quot; &quot;anticipates,&quot; &quot;believes,&quot; &quot;intends,&quot; &quot;continue,&quot; &quot;expects,&quot; other words of similar meaning, derivations of such words and the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause the company&#39;s actual results to be materially different than those expressed in or implied by such forward-looking statements. Particular uncertainties and risks include: general business and economic conditions; <font style="font-family:Times New Roman, Times, serif;font-size:10pt;">the timing, success and results of the INTACT trial; the company&#39;s need for and ability to obtain additional financing; and the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance, and the various risk factors (many of which are beyond Diffusion&rsquo;s control) as described under the heading &ldquo;Risk Factors&rdquo; in Diffusion&rsquo;s filings with the United States Securities and Exchange Commission. All forward-looking statements in this news release speak only as of the date of this news release and are based on management&#39;s current beliefs and expectations. Diffusion undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.</font></p>

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

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><b>Contact</b><font style="font-family:Times New Roman, Times, serif;font-size:10pt;"><b>s</b><b>:</b></font></p>

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;">David Kalergis<font style="font-family:Times New Roman, Times, serif;font-size:10pt;">, CEO</font></p>

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Diffusion Pharmaceuticals Inc.</p>

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;">(434) 220-0718</p>

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><u>dkalergis@diffusionpharma.com</u></p>

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;text-indent:36pt;">or</p>

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;">LHA Investor Relations</p>

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Kim Sutton Golodetz</p>

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;">(<font style="font-family:Times New Roman, Times, serif;font-size:10pt;">212) 838-3777</font></p>

<p style="font-family:Times New Roman, Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><u>kgolodetz@lhai.com</u></p>

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

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