<SEC-DOCUMENT>0001437749-21-007186.txt : 20210325
<SEC-HEADER>0001437749-21-007186.hdr.sgml : 20210325
<ACCEPTANCE-DATETIME>20210325172056
ACCESSION NUMBER:		0001437749-21-007186
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20210325
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20210325
DATE AS OF CHANGE:		20210325

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:		21773578

	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>dffn20210325_8k.htm
<DESCRIPTION>FORM 8-K
<TEXT>
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<p style="font-family:Times New Roman;font-size:12pt;font-variant:normal;text-align:center;margin:0pt;"><b>UNITED STATES</b></p>

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

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

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<p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;">&nbsp;</p>

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

<p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;">&nbsp;</p>

<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:center;margin:0pt;"><b>CURRENT REPORT</b></p>

<p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;">&nbsp;</p>

<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:center;margin:0pt;"><b>Pursuant to Section 13 or 15(d) of</b></p>

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

<p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;">&nbsp;</p>

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<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:center;margin:0pt;"><b>Date of Report (Date of earliest event reported): March 25, 2021</b></p>

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<p style="font-family:Times New Roman;font-size:18pt;font-variant:normal;text-align:center;margin:0pt;"><b>DIFFUSION PHARMACEUTICALS INC.</b></p>

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

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			<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:center;margin:0pt;"><b>Delaware</b></p>
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			<td style="vertical-align:top;width:33.7%;">
			<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:center;margin:0pt;"><b>000-24477</b></p>
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			<td style="vertical-align:top;width:33.7%;">
			<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:center;margin:0pt;"><b>30-0645032</b></p>
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			<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:center;margin:0pt;">(State or other jurisdiction of incorporation)</p>
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			<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:center;margin:0pt;">(Commission File</p>

			<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:center;margin:0pt;">Number)</p>
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			<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:center;margin:0pt;">(I.R.S. Employer</p>

			<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:center;margin:0pt;">Identification No.)</p>
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<p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;">&nbsp;</p>

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			<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:center;margin:0pt;"><b>1317 Carlton Avenue, Suite 200</b></p>

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

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

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

<p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;">&nbsp;</p>

<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:center;margin:0pt;"><b>Not applicable</b></p>

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

<p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;">&nbsp;</p>

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

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			<p style="margin: 0pt; text-align: justify; font-family: Times New Roman; font-size: 10pt;">&#9744;</p>
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			<td style="font-family: Times New Roman; font-size: 10pt;">
			<p style="margin: 0pt; text-align: justify; font-family: Times New Roman; font-size: 10pt;">Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)</p>
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			<p style="margin: 0pt; text-align: justify; font-family: Times New Roman; font-size: 10pt;">&#9744;</p>
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			<td style="font-family: Times New Roman; font-size: 10pt;">
			<p style="margin: 0pt; text-align: justify; font-family: Times New Roman; font-size: 10pt;">Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)</p>
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			<td style="width: 18pt; font-family: Times New Roman; font-size: 10pt;">
			<p style="margin: 0pt; text-align: justify; font-family: Times New Roman; font-size: 10pt;">&#9744;</p>
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			<td style="font-family: Times New Roman; font-size: 10pt;">
			<p style="margin: 0pt; text-align: justify; font-family: Times New Roman; font-size: 10pt;">Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))</p>
			</td>
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<table border="0" cellpadding="0" cellspacing="0" style="width: 100%; text-indent: 0px; font-family: Times New Roman; font-size: 10pt;">

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			<td style="width: 18pt; font-family: Times New Roman; font-size: 10pt;">
			<p style="margin: 0pt; text-align: justify; font-family: Times New Roman; font-size: 10pt;">&#9744;</p>
			</td>
			<td style="font-family: Times New Roman; font-size: 10pt;">
			<p style="margin: 0pt; text-align: justify; font-family: Times New Roman; font-size: 10pt;">Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))</p>
			</td>
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<p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;">&nbsp;</p>

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

<p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;">&nbsp;</p>

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			<p style="font-family: Times New Roman; font-size: 10pt; font-variant: normal; text-align: justify; margin: 0pt 0pt 0pt 9pt;">Title of each class</p>
			</td>
			<td style="border-bottom: 1px solid rgb(0, 0, 0); vertical-align: top; width: 24.6%; border-top: 1px solid black; border-right: 1px solid black;">
			<p style="font-family: Times New Roman; font-size: 10pt; font-variant: normal; text-align: justify; margin: 0pt 0pt 0pt 9pt;">Trading Symbol(s)</p>
			</td>
			<td style="border-bottom: 1px solid rgb(0, 0, 0); vertical-align: top; width: 33.7%; border-top: 1px solid black; border-right: 1px solid black;">
			<p style="font-family: Times New Roman; font-size: 10pt; font-variant: normal; text-align: justify; margin: 0pt 0pt 0pt 9pt;">Name of each exchange on which registered</p>
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			<td style="border-bottom: 1px solid rgb(0, 0, 0); vertical-align: top; width: 42.8%; border-left: 1px solid black; border-right: 1px solid black;">
			<p style="font-family: Times New Roman; font-size: 10pt; font-variant: normal; text-align: justify; margin: 0pt 0pt 0pt 9pt;">Common Stock, par value $0.001 per share</p>
			</td>
			<td style="border-bottom: 1px solid rgb(0, 0, 0); vertical-align: top; width: 24.6%; border-right: 1px solid black;">
			<p style="font-family: Times New Roman; font-size: 10pt; font-variant: normal; text-align: justify; margin: 0pt 0pt 0pt 9pt;">DFFN</p>
			</td>
			<td style="border-bottom: 1px solid rgb(0, 0, 0); vertical-align: top; width: 33.7%; border-right: 1px solid black;">
			<p style="font-family: Times New Roman; font-size: 10pt; font-variant: normal; text-align: justify; margin: 0pt 0pt 0pt 9pt;">NASDAQ Capital Market</p>
			</td>
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<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:justify;margin:0pt;">&nbsp;</p>

<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:justify;margin:0pt;"><b>Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (</b>&#167;&#8201;<b>230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (</b>&#167;&#8201;<b>240.12b-2 of this chapter).</b></p>

<p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;">&nbsp;</p>

<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:justify;margin:0pt;"><b>Emerging growth company</b>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<b>&#9744;</b>&nbsp;&nbsp;&nbsp;</p>

<p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;">&nbsp;</p>

<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:justify;margin:0pt;"><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. </b>&nbsp;&nbsp;&nbsp;&nbsp;<b>&nbsp;&#9744;</b></p>

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

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<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;font-size:10pt;font-variant:normal;text-align:justify;margin:0pt;"><b>Item 8.01</b>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<b>Other Events</b></p>

<p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;">&nbsp;</p>

<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:justify;margin:0pt;">On March 25, 2021, Diffusion Pharmaceuticals Inc. (the &#8220;Company&#8221;) issued a press release announcing the completion of enrollment and dosing in the Company&#8217;s Phase 1 trial of its novel, oxygen enhancing therapeutic, trans sodium crocetinate (&#8220;TSC&#8221;), utilizing a transcutaneous oxygen monitoring device to evaluate the effects of TSC on peripheral tissue oxygenation. A copy of the press release is attached hereto as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.</p>

<p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;">&nbsp;</p>

<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:justify;margin:0pt;"><b>Item</b>&nbsp;<b>9.01 </b>&#8211;<b> Financial Statements and Exhibits</b></p>

<p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;">&nbsp;</p>

<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:justify;margin:0pt;"><b>(d) Exhibits </b></p>

<p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;">&nbsp;</p>

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			<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:justify;margin:0pt;"><b>Exhibit </b></p>

			<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:justify;margin:0pt;"><b>Number</b></p>
			</td>
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			<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:center;margin:0pt;"><b>Description</b></p>
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			<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:justify;margin:0pt;">99.1</p>
			</td>
			<td>
			<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:justify;margin:0pt;"><a href="ex_236819.htm" style="-sec-extract:exhibit;">Press Release, issued March 25, 2021</a></p>
			</td>
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<p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;">&nbsp;</p>

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<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:center;margin:0pt;"><b>SIGNATURES</b></p>

<p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;">&nbsp;</p>

<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:justify;margin:0pt;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;font-size:10pt;font-variant:normal;text-align:justify;margin:0pt;text-indent:36pt;">&nbsp;</p>

<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:justify;margin:0pt;text-indent:36pt;">&nbsp;</p>

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			<p style="margin-top: 0; margin-bottom: 0; font-family: &quot;Times New Roman&quot;; font-size: 10pt">Dated: March 25, 2021</p>
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			<td rowspan="1" style="width: 55%;" valign="top" width="38%">
			<p style="margin-top: 0; margin-bottom: 0; font-family: &quot;Times New Roman&quot;; font-size: 10pt"><b>DIFFUSION PHARMACEUTICALS INC.</b></p>
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<p style="margin: 0; font-family: &quot;Times New Roman&quot;; font-size: 10pt">&nbsp;</p>

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			<p style="margin-top: 0; margin-bottom: 0; font-family: &quot;Times New Roman&quot;; font-size: 10pt"><font style="font-family: 'Times New Roman', Times, serif; font-size: 10pt">&nbsp;</font></p>
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			<p style="margin-top: 0; margin-bottom: 0; font-family: &quot;Times New Roman&quot;; font-size: 10pt"><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-family: &quot;Times New Roman&quot;; font-size: 10pt"><font style="font-family: 'Times New Roman', Times, serif; font-size: 10pt">/s/&nbsp;</font>William Elder</p>
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			<td style="width: 10%;" valign="top" width="12%">
			<p style="margin-top: 0; margin-bottom: 0; font-family: &quot;Times New Roman&quot;; font-size: 10pt"><font style="font-family: 'Times New Roman', Times, serif; font-size: 10pt">&nbsp;</font></p>
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			<p style="margin-top: 0; margin-bottom: 0; font-family: &quot;Times New Roman&quot;; font-size: 10pt"><font style="font-family: 'Times New Roman', Times, serif; font-size: 10pt">&nbsp;</font></p>
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			<p style="margin-top: 0; margin-bottom: 0; font-family: &quot;Times New Roman&quot;; font-size: 10pt">Name:</p>
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			<p style="margin-top: 0; margin-bottom: 0; font-family: &quot;Times New Roman&quot;; font-size: 10pt">William Elder</p>
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			<td style="width: 10%;" valign="top" width="12%">
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			<p style="margin-top: 0; margin-bottom: 0; font-family: &quot;Times New Roman&quot;; font-size: 10pt">Title:</p>
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<FILENAME>ex_236819.htm
<DESCRIPTION>EXHIBIT 99.1
<TEXT>
<html><head><meta charset="utf-8"><meta name="format-detection" content="telephone=no"><!--Created on 3/25/2021 10:14:37 AM --><meta name="generator" content="RDG HTML Converter 3.4.3.0">
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<p style="margin-bottom: 0; text-align: right; margin-top: 0; font-family: &quot;Times New Roman&quot;; font-size: 10pt"><font style="font-family: 'Times New Roman', Times, serif; font-size: 10pt"><b>Exhibit 99.1</b></font></p>

<p style="margin: 0; text-align: left; font-family: &quot;Times New Roman&quot;; font-size: 10pt"><font style="font-family: 'Times New Roman', Times, serif; font-size: 10pt">&nbsp;</font><img alt="logo.jpg" src="logo.jpg"></p>

<p style="font-family:Times New Roman;font-size:12pt;font-variant:normal;text-align:center;margin:0pt;"><b>Diffusion Pharmaceuticals Completes Enrollment and Dosing in TCOM Study </b></p>

<p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;">&nbsp;</p>

<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;margin:0pt;">CHARLOTTESVILLE, Va., March 25, 2021 --&nbsp;<b>Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN)</b>&nbsp;(&#8220;Diffusion&#8221; or the &#8220;Company&#8221;), an innovative biopharmaceutical company developing novel therapies that enhance the body&#8217;s ability to deliver oxygen to areas where it is needed most, today announced it has completed enrollment and dosing of all participants in the Company&#8217;s Phase 1 trial of its novel, oxygen enhancing therapeutic, trans sodium crocetinate (&#8220;TSC&#8221;), utilizing a transcutaneous oxygen monitoring (TCOM) device to evaluate the pharmacodynamic effects of TSC on peripheral tissue oxygenation.</p>

<p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;">&nbsp;</p>

<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;margin:0pt;">The TCOM trial is the first in a series of three short-term Oxygenation Trials that Diffusion plans to conduct in the United States in 2021. Together, these Oxygenation Trials will serve as a prospective exploration of the relationship between the level of TSC exposure (dose) and response (change in oxygenation) and the Company expects positive data from any of the three Oxygenation Trials, if obtained, will guide the next phases of TSC&#8217;s clinical development and commercialization plans. The Company intends to fund these three studies with cash-on-hand.</p>

<p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;">&nbsp;</p>

<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;margin:0pt;">The TCOM trial was a randomized, double blind, placebo controlled, pharmacokinetic and pharmacodynamic study of TSC that enrolled and dosed 30 healthy volunteers. Trial participants were randomized into one of six subgroups and each received a single intravenous dose of placebo or one of five different doses of TSC ranging from 0.5-2.5 mg/kg. All trial participants received supplemental oxygen during equivalent monitoring periods before and after TSC or placebo was administered while being continuously monitored with TCOM sensors applied to the lower extremity. The primary endpoint evaluates the relative change in TCOM readings from baseline after TSC administration. Diffusion anticipates that the ongoing collection and analyses of the TCOM trial data will be completed and announced in the second quarter of 2021.</p>

<p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;">&nbsp;</p>

<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;margin:0pt;">&#8220;We expect the results of the TCOM trial to provide important information about TSC&#8217;s ability to enhance oxygen delivery to tissues, while further clarifying dose and duration of effects&#8221; said Christopher Galloway, M.D., Chief Medical Officer of Diffusion. &#8220;I am ever grateful to the volunteers and thrilled that the trial was able to fully enroll so quickly. We now eagerly await the objective analysis of the trial, recognizing we have two other Oxygenation Trials yet to be conducted this year.&#8221;</p>

<p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;">&nbsp;</p>

<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;margin:0pt;"><b>Near-term Clinical Strategy</b></p>

<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;margin:0pt;">In addition to the TCOM trial, the Company plans to initiate the following two, additional Oxygenation Trials in the third quarter of 2021:</p>

<p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;">&nbsp;</p>

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			<p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;">&#9679;</p>
			</td>
			<td style="vertical-align:top;">
			<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;margin:0pt;"><b>Hypoxia Trial: </b>This is expected to be a double-blind, randomized, placebo-controlled study which will evaluate the effects of TSC on maximal oxygen consumption, or VO2, and partial pressure of blood oxygen, or PaO2, in normal healthy volunteers subjected to incremental levels of physical exertion while exposed to hypoxic and hypobaric conditions.</p>
			</td>
		</tr>

</table>

<p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;">&nbsp;</p>

<table border="0" cellpadding="0" cellspacing="0" style="width:100%;font-family:Times New Roman;font-size:10pt;">

		<tr>
			<td style="vertical-align:top;width:18pt;">
			<p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;">&#9679;</p>
			</td>
			<td style="vertical-align:top;">
			<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;margin:0pt;"><b>DLCO Trial: </b>This is expected to be a double-blind, randomized, placebo-controlled study which will evaluate the effects of TSC on the diffusion of carbon monoxide through the lungs, also known as DLCO, in patients with previously diagnosed interstitial lung disease who have a baseline DLCO test result that is abnormal. DLCO will act as a surrogate measure of oxygen transfer efficiency, or uptake, from the alveoli of the lungs, through the plasma, and onto hemoglobin within red blood cells.</p>
			</td>
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<p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;">&nbsp;</p>

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<div class="hf-cell TOCLink">&nbsp;</div>
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<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"><img alt="logo.jpg" src="logo.jpg"></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;font-size:10pt;font-variant:normal;margin:0pt;">The Company expects positive data from any of the three Oxygenation Trials will drive the next steps in the TSC clinical development strategy, which is focused on demonstrating the therapeutic value of TSC in a applicable patient population affected by hypoxia. Assuming success in any one or more of the Oxygenation Trials, Diffusion expects to identify and announce the specific, hypoxia-related indication(s) on which it will focus further clinical development in the fourth quarter of 2021. The Company then plans to initiate a Phase 2 clinical outcome study evaluating TSC in the announced indication(s) during the first quarter of 2022.</p>

<p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;">&nbsp;</p>

<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;margin:0pt;"><b>About Diffusion Pharmaceuticals Inc.</b></p>

<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:justify;margin:0pt;">Diffusion Pharmaceuticals Inc. is an innovative biopharmaceutical company developing novel therapies that enhance the body&#8217;s ability to deliver oxygen to areas where it is needed most. Diffusion&#8217;s lead product candidate, TSC, is being developed to enhance the diffusion of oxygen to tissues with low oxygen levels, also known as hypoxia, a serious complication of many of medicine&#8217;s most intractable and difficult-to-treat conditions. In addition to TSC, Diffusion&#8217;s product candidate DFN-529, a novel, allosteric PI3K/Akt/mTOR Pathway inhibitor, is in early-stage development. For more information, please visit us at <u>www.diffusionpharma.com</u>.</p>

<p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;">&nbsp;</p>

<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;margin:0pt;"><b>Forward-Looking Statements</b></p>

<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;text-align:justify;margin:0pt;">This press release includes express and implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding the Company&#8217;s anticipated cash runway, its near-term strategic priorities, and anticipated timelines for the initiation, completion, and announcement of data from the Company&#8217;s ongoing and planned oxygenation trials. The Company may, in some cases, use terms such as &#8220;believes,&#8221; &#8220;estimates,&#8221; &#8220;anticipates,&#8221; &#8220;expects,&#8221; &#8220;plans,&#8221; &#8220;intends,&#8221; &#8220;may,&#8221; &#8220;could,&#8221; &#8220;might,&#8221; &#8220;will,&#8221; &#8220;should,&#8221; &#8220;approximately,&#8221; or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Although the Company believes that it has a reasonable basis for each forward-looking statement contained herein, forward-looking statements by their nature involve risks and uncertainties, known and unknown, many of which are beyond the Company&#8217;s control, and as a result the Company&#8217;s actual results could differ materially from those expressed or implied in any forward-looking statement. Particular risk and uncertainties include, among other things, those related to: the Company&#8217;s ability to design, initiate, enroll, execute, and complete its ongoing and planned studies evaluating TSC; general economic, political, business, industry, and market conditions, including the ongoing COVID-19 pandemic; and the other factors discussed under the heading &#8220;Risk Factors&#8221; in the Company&#8217;s filings most recent Annual Report on Form 10-K and other filings with the U.S. Securities and Exchange Commission. Any forward-looking statements in this press release speak only as of the date hereof (or such earlier date as may be identified) and, except as required by applicable law, rule, or regulation, the Company undertakes no obligation to update any such statements after the date hereof.</p>

<p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;">&nbsp;</p>

<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;margin:0pt;"><b>Contacts</b></p>

<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;margin:0pt;"><b>Investors:</b>&nbsp;&nbsp;<br>
<u>Tiberend Strategic Advisors, Inc.</u>&nbsp;<br>
Maureen McEnroe, CFA/Miriam Weber Miller&nbsp;<br>
(212)&nbsp;375-2664 / (212) 375-2694&nbsp;&nbsp;<br>
<u>mmcenroe@tiberend.com</u>&nbsp;/&nbsp;<u>mmiller@tiberend.com</u></p>

<p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;">&nbsp;</p>

<p style="font-family:Times New Roman;font-size:10pt;font-variant:normal;margin:0pt;"><b>Media:</b>&nbsp;&nbsp;<br>
Jeffrey Freedman&nbsp;<br>
RooneyPartners&nbsp;&nbsp;<br>
(646) 432-0191&nbsp;<br>
<u>jfreedman@rooneyco.com</u></p>

<p style="font-family:'Times New Roman';font-size:10pt;font-variant:normal;margin:0pt;">&nbsp;</p>

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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
