<SEC-DOCUMENT>0001437749-20-008768.txt : 20200429
<SEC-HEADER>0001437749-20-008768.hdr.sgml : 20200429
<ACCEPTANCE-DATETIME>20200429084453
ACCESSION NUMBER:		0001437749-20-008768
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20200427
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20200429
DATE AS OF CHANGE:		20200429

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:		20827581

	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>dffn20200428_8k.htm
<DESCRIPTION>FORM 8-K
<TEXT>
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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:0pt;text-align:center;text-transform:uppercase;">________________</p>

<p style="font-family: Times New Roman; font-size: 10pt; margin: 0pt; text-align: center; text-transform: uppercase;">&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: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;">&nbsp;</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:10pt;margin:0pt;text-align:center;"><b>Date of Report (Date of earliest event reported): </b><b>April 27</b><b>, 2020</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-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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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><b>Delaware</b></p>
			</td>
			<td style="vertical-align: top; width: 34%; 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:center;"><b>000-24477</b></p>
			</td>
			<td style="vertical-align: top; width: 33%; 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:center;"><b>30-0645032</b></p>
			</td>
		</tr>
		<tr style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">
			<td style="vertical-align: top; width: 33%; 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: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: 34%; 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: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%; 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: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>
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<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 200</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>
			<td style="vertical-align: top; width: 50%; 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: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%; 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:center;">(Address of principal executive offices)</p>
			</td>
			<td style="vertical-align: top; width: 50%; 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:center;">(Zip Code)</p>
			</td>
		</tr>

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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&#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-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>

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

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

<table border="0" cellpadding="0" cellspacing="0" style="margin-left:0.1%;width:99.9%;text-indent:0;font-family:'Times New Roman', Times, serif;font-size:10pt;">

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			<td style="border-color: black black rgb(0, 0, 0); border-style: solid; border-width: 1px; vertical-align: top; width: 33.3%;">
			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Title of each class</p>
			</td>
			<td style="border-bottom: 1px solid rgb(0, 0, 0); vertical-align: top; width: 33.3%; border-top: 1px solid black; border-right: 1px solid black;">
			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Trading Symbol(s)</p>
			</td>
			<td style="border-bottom: 1px solid rgb(0, 0, 0); vertical-align: top; width: 33.3%; border-right: 1px solid black; border-top: 1px solid black;">
			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Name of each exchange on which registered</p>
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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Common Stock, par value $0.001 per share</p>
			</td>
			<td style="border-bottom: 1px solid rgb(0, 0, 0); vertical-align: top; width: 33.3%; border-right: 1px solid black;">
			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">DFFN</p>
			</td>
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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Nasdaq Capital Market</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;"><b>Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (&#167;&#8201;230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (&#167;&#8201;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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</b>&#9744;</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.&nbsp;</b>&#9744;</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="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;"><b>Item </b><b>8</b><b>.01 </b><b>Other Events</b></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:justify;">On April 27, 2020, Diffusion Pharmaceuticals Inc. (the &#8220;Company&#8221;) issued a press release announcing the pre-IND submission to the U.S. Food and Drug Administration (FDA) of a planned clinical program using trans sodium crocetinate (TSC) in COVID-19 patients displaying severe respiratory symptoms and low oxygen levels. A copy of the press release is attached hereto as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.</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>Item&nbsp;9.01 &#8211; Financial Statements and Exhibits</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>(d) Exhibits </b></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-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">99.1</p>
			</td>
			<td>
			<p style="margin: 0pt; text-align: justify; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;"><a href="ex_183291.htm" style="-sec-extract:exhibit;">Press release issued April 27, 2020</a></p>
			</td>
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<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: left">&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: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>

<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>

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			<td style="width: 50%;">Dated: April 29, 2020&nbsp;</td>
			<td colspan="3" style="width: 35%;"><b>DIFFUSION PHARMACEUTICALS INC.</b></td>
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			<td style="width: 50%;">&nbsp;</td>
			<td colspan="3" style="width: 35%;">&nbsp;</td>
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			<td style="width: 50%;">&nbsp;</td>
			<td colspan="3" style="width: 35%;">&nbsp;</td>
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			<td style="width: 50%;">&nbsp;</td>
			<td style="width: 5%;">By:</td>
			<td style="width: 30%; border-bottom: 1px solid black;">/s/ David G. Kalergis&nbsp;</td>
			<td style="width: 15%;">&nbsp;</td>
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		<tr>
			<td style="width: 50%;">&nbsp;</td>
			<td style="width: 5%;">Name:</td>
			<td colspan="2" style="width: 30%;">David G. Kalergis</td>
		</tr>
		<tr>
			<td style="width: 50%;">&nbsp;</td>
			<td style="width: 5%;">Title:</td>
			<td colspan="2" style="width: 30%;">Chief Executive Officer</td>
		</tr>

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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>ex_183291.htm
<DESCRIPTION>EXHIBIT 99.1
<TEXT>
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	<title>ex_183291.htm</title>

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<p style="margin-bottom: 0px; text-align: right; margin-top: 0px"><font style="font-family: 'Times New Roman', Times, serif; font-size: 10pt"><b>Exhibit 99.1</b></font></p>

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<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><b>Diffusion Pharmaceuticals</b><b> Announces </b><b>Pre-IND </b><b>Submission to the FDA </b><b>of </b><b>Design</b><b> </b><b>for </b><b>TSC </b><b>Trials to Treat Acute Respiratory Distress Syndrome in COVID-19</b></p>

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<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><i>&#9679;&nbsp;&nbsp;&nbsp; Program to focus on enhanced</i><i> blood oxygenation and </i><i>reduction in </i><i>patient </i><i>progression to Intensive Care Units</i></p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><i>&#9679;&nbsp;&nbsp;&nbsp;&nbsp; Patient enrollment planned for </i><i>both the U.S. and Eastern Europe </i></p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin-bottom:0pt;margin-left:18pt;margin-right:0pt;margin-top:0pt;text-align:center;"><i><b>&nbsp;</b></i></p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><b>CHARLOTTESVILLE, Va. (</b><b>April </b><b>27</b><b>, 2020</b><b>) &#8211; Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN)</b> (&#8220;Diffusion&#8221; or &#8220;the Company&#8221;), a cutting-edge biotechnology company developing new treatments for life-threatening medical conditions by improving the body&#8217;s ability to deliver oxygen to the areas where it is needed most, today announced the pre-IND submission to the U.S. Food and Drug Administration (FDA) of a planned clinical program using trans sodium crocetinate (TSC) in COVID-19 patients displaying severe respiratory symptoms and low oxygen levels. Under federal regulations, the FDA has up to 60 days to hold an advisory meeting with the Company, but for COVID-19-related submissions, the FDA has announced its intention to significantly shorten this period under its Coronavirus Treatment Acceleration Program. Clinical trial start-up preparations are continuing as the Company awaits the FDA&#8217;s response.</p>

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<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">To aid in timely trial enrollment, Diffusion is conducting expedited discussions with institutions located in areas of severe COVID-19 incidence, both in the U.S. and in Eastern Europe, to determine their possible participation.</p>

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<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Acute Respiratory Distress Syndrome (ARDS) develops in nearly all patients hospitalized with COVID-19, triggered by lack of sufficient oxygen to vital organs as a consequence of damage to the lungs. In severe cases, patients need to receive life support through mechanical ventilation. In general, ARDS carries a high mortality rate (up to 40% in those on a breathing machine, and likely higher in COVID-19-related ARDS). Diffusion believes that through successful implementation of its TSC/COVID-19 clinical program, TSC&#8217;s oxygen-enhancing mechanism of action could provide an important new treatment option for this life-threatening unmet medical need. Further, the Company believes that TSC&#8217;s novel mechanism of action would be compatible with many of the COVID-19 treatment modalities currently used or under development.</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;">Although the number, design and projected enrollment of the clinical trials are subject to change, Diffusion&#8217;s pre-IND submission for TSC envisions three studies to be conducted in rapid succession. The first is an open-label study that will examine the basic safety of the TSC dosing paradigm in up to 12 COVID-19 patients who have been admitted to Intensive Care Units (ICUs.) In addition to the primary endpoint of safety, blood gas and pulse oximetry data also will be collected to observe TSC&#8217;s possible effect on increasing oxygenation in these oxygen-starved patients.</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 second trial is planned as a larger, double-blinded, randomized, placebo-controlled study to confirm safety in the ICU patient population and determine the statistical significance of any effect on the patient&#8217;s oxygenation status from TSC, again using blood gas analysis and pulse oximetry. The number of patients enrolled will be determined by statistical considerations. Data also will be collected for other endpoints including mortality.</p>

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<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Assuming results from the second study warrant program continuation, the third study, also double-blinded, randomized and placebo controlled, would enroll a statistically determined number of hospitalized COVID-19 patients who have not yet been admitted to an ICU, and therefore may not have arterial blood lines in place. While pulse oximetry readouts and other parameters will be monitored for possible improvements in patient status, the primary goal of this third study, intended to be a registration trial, will be to show that TSC lowers the probability of COVID-19 patient admittance to the ICU. Diffusion believes that achieving this goal would provide an important new tool for healthcare professionals as they fight to prevent the cascade of negative effects from oxygen deficiency in hospitalized COVID-19 patients, which too often lead to disease progression and mortality. Meeting this goal could also provide significant cost savings to the health care system, lessening the use of critical resources associated with ICU admittance and fostering TSC&#8217;s more widespread use.</p>

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<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Diffusion&#8217;s COVID-19 program is a cooperative research effort with the University of Virginia Health System (UVA) and the Integrated Translational Research Institute of Virginia (iTHRIV.) iTHRIV is a National Institutes of Health (NIH)-funded Clinical and Translational Awards (CTSA) program. Dr. Andrew Southerland, Associate Professor of Neurology and Public Health Sciences at UVA, serves as lead Principal Investigator, working with co-investigator Dr. Alex Kadl, Assistant Professor of Medicine and Pharmacology in the UVA Division of Pulmonary &amp; Critical Care Medicine.</p>

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<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">&#8220;Despite 50 years of research,&#8221; said Dr. Kadl, &#8220; there are no pharmaceutical therapies for ARDS. We further know that maintaining adequate blood oxygenation with needed mechanical ventilation can cause further harm and damage to the lungs. Improving oxygenation with TSC may prevent severe hypoxia and the need for mechanical ventilation, giving the lungs the time needed to recover from COVID-19 infection.&#8221;</p>

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<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">&#8220;We believe TSC&#8217;s novel oxygen-enhancing mechanism could have a direct effect on the systemic hypoxemia in COVID-19 patients, altering the downward spiral of disease progression and decreasing the necessity for ARDs-related admissions to the ICU,&#8221; said David Kalergis, chief executive officer of Diffusion. &#8220;We are committed to working with hospitals and regulatory authorities both in the U.S. and Eastern Europe to forge the fastest possible pathway to TSC&#8217;s approval, consistent with good clinical practices.&#8221;</p>

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

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<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Diffusion Pharmaceuticals Inc. is an innovative biotechnology company developing new treatments that improve the body&#8217;s ability to deliver oxygen to the areas where it is needed most, offering new hope for the treatment of life-threatening medical conditions. Diffusion&#8217;s lead drug trans sodium crocetinate (TSC) was originally developed in conjunction with the Office of Naval Research, which was seeking a way to treat multiple organ failure and its resulting mortality caused by the systemic hypoxemia from blood loss on the battlefield. Evolutions in research have led to Diffusion&#8217;s focus today: Fueling Life by taking on some of medicine&#8217;s most intractable and difficult-to-treat diseases, including multiple organ failure, stroke and glioblastoma multiforme (GBM) brain cancer. In each of these diseases, hypoxia &#8211; oxygen deprivation of essential tissue in the body &#8211; has proved to be a significant obstacle for medical providers and is the target for TSC&#8217;s novel mechanism.</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;">In July 2019 the Company reported favorable safety data in a 19-patient dose-escalation run-in study to its Phase 3 INTACT program, using TSC to target inoperable GBM. Further findings from the dose-escalation run-in study, released in December 2019, also showed possible signals of enhanced survival and patient performance. Diffusion&#8217;s in-ambulance PHAST-TSC trial for acute stroke began enrolling patients last year. Given the heightened responsibilities of the Company&#8217;s emergency medical services providers, enrollment in this trial is expected to be minimal until the COVID-19 pandemic abates. The Company is also currently partnering with the University of Virginia and iTHRIV in a research program to develop its novel small molecule TSC as a treatment for Acute Respiratory Distress Syndrome (ARDS) from COVID-19, specifically targeting the associated multiple organ failure.</p>

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<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Preclinical data supports the potential for TSC as a treatment for other conditions where hypoxia plays a major role, such as myocardial infarction, peripheral artery disease, and neurodegenerative conditions such as Alzheimer&#8217;s and Parkinson&#8217;s disease. In addition, RES-529, the Company&#8217;s PI3K/AKT/mTOR pathway inhibitor that dissociates the mTORC1 and mTORC2 complexes, is in preclinical testing for GBM.</p>

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<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">Diffusion is headquartered in Charlottesville, Virginia &#8211; a hub of advancement in the life science and biopharmaceutical industries &#8211; and is led by CEO David Kalergis, a 30-year industry veteran and company co-founder.</p>

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

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<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's plans, objectives, expectations and intentions with respect to future operations and products, the potential of the company's technology and product candidates, and other statements that are not historical in nature, particularly those that utilize terminology such as "would," "will," "plans," "possibility," "potential," "future," "expects," "anticipates," "believes," "intends," "continue," "expects," 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 Diffusion&#8217;s actual results to be materially different than those expressed in or implied by such forward-looking statements. Particular uncertainties and risks include: the uncertainty as to whether the protocol described above, which is a pre-IND submission, will be ultimately acceptable to the FDA for an IND submission or that the FDA will not require significant changes that might take significant time to implement, if at all, or that any such required changes will be financially feasible; moreover, if this or a revised protocol is acceptable to the FDA for an IND submission, there can be no assurance as to when the FDA might provide such guidance or when the program might be able to commence, if at all; the uncertainty that as of yet the FDA has no approved a trial evaluating TSC for the treatment of ARDS, or if approved, such a trial possibly entailing significant additional time, effort and expense, particularly in light of the difficulty of doing business during the COVID-19 pandemic; Diffusion&#8217;s ability to maintain its Nasdaq listing, market conditions, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; general business and economic conditions; the sufficiency of the company&#8217;s cash, the company's need for and ability to obtain additional financing or partnering arrangements; and the various risk factors (many of which are beyond Diffusion&#8217;s control) as described under the heading &#8220;Risk Factors&#8221; in Diffusion&#8217;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'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.</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:left;">Contacts:</p>

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

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

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">(434) 825-1834</p>

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

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

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

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

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

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

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