<SEC-DOCUMENT>0001564590-20-057156.txt : 20201215
<SEC-HEADER>0001564590-20-057156.hdr.sgml : 20201215
<ACCEPTANCE-DATETIME>20201215161524
ACCESSION NUMBER:		0001564590-20-057156
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20201215
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20201215
DATE AS OF CHANGE:		20201215

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			ARCA biopharma, Inc.
		CENTRAL INDEX KEY:			0000907654
		STANDARD INDUSTRIAL CLASSIFICATION:	IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835]
		IRS NUMBER:				363855489
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	000-22873
		FILM NUMBER:		201389765

	BUSINESS ADDRESS:	
		STREET 1:		11080 CIRCLEPOINT ROAD
		STREET 2:		SUITE 140
		CITY:			WESTMINSTER
		STATE:			CO
		ZIP:			80020
		BUSINESS PHONE:		720-940-2200

	MAIL ADDRESS:	
		STREET 1:		11080 CIRCLEPOINT ROAD
		STREET 2:		SUITE 140
		CITY:			WESTMINSTER
		STATE:			CO
		ZIP:			80020

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	NUVELO INC
		DATE OF NAME CHANGE:	20030203

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	HYSEQ INC
		DATE OF NAME CHANGE:	19970610
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>abio-8k_20201215.htm
<DESCRIPTION>8-K
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<p style="text-align:center;margin-top:9pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-size:18pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">FORM 8-K </p>
<p style="text-align:center;margin-top:9pt;line-height:4pt;border-bottom:Solid 1pt;padding-bottom:1pt;margin-bottom:0pt;margin-left:40%;margin-right:40%;text-indent:0%;font-size:6pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#160;</p>
<p style="text-align:center;margin-top:9pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-size:12pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">CURRENT REPORT </p>
<p style="text-align:center;margin-top:9pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-size:12pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 </p>
<p style="text-align:center;margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;">Date of Report (Date of earliest event reported):<font style="color:#000000;font-size:12pt;"> </font><font style="color:#000000;">December 15, 2020</font></p>
<p style="text-align:center;border-bottom:Solid 0.75pt;padding-bottom:1pt;margin-bottom:0pt;margin-top:0pt;margin-left:40%;margin-right:40%;text-indent:0%;font-weight:bold;;font-size:12pt;">&nbsp;</p>
<p style="text-align:center;margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-size:24pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">ARCA biopharma, Inc.</p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:7.5pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">(Exact name of Registrant as Specified in Its Charter)</p>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;font-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;">36-3855489</p></td>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;font-size:7.5pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">of Incorporation)</p></td>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;font-size:7.5pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">(Commission File Number)</p></td>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;font-size:7.5pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">(IRS Employer</p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;font-size:7.5pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Identification No.)</p></td>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;;font-size:8pt;">&nbsp;</p></td>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;;font-size:8pt;">&nbsp;</p></td>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;font-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;">10170 Church Ranch Way, Suite 100, Westminster, CO</p></td>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;font-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;">80021</p></td>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;font-size:7.5pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">(Address of Principal Executive Offices)</p></td>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;font-size:7.5pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">(Zip Code)</p></td>
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<p style="text-align:center;margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;">Registrant&#8217;s Telephone Number, Including Area Code: (720) 940-2200</p>
<p style="text-align:center;margin-top:9pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;">Not Applicable </p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:7.5pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;"> (Former Name or Former Address, if Changed Since Last Report) </p>
<p style="text-align:center;border-bottom:Solid 0.75pt;padding-bottom:1pt;margin-bottom:0pt;margin-top:0pt;margin-left:40%;margin-right:40%;text-indent:0%;font-weight:bold;;font-size:12pt;">&nbsp;</p>
<p style="margin-top:9pt;margin-bottom:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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 (see General Instructions A.2. below): </p>
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<p style="margin-top:9pt;margin-bottom:0pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-family:Times New Roman;font-size:10pt;">Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) </p></td></tr></table></div>
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<p style="margin-top:9pt;margin-bottom:0pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;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></td></tr></table></div>
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<p style="margin-top:9pt;margin-bottom:0pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;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></tr></table></div>
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<p style="margin-top:9pt;margin-bottom:0pt;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-family:'Times New Roman';"><font style="font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-family:'Times New Roman';"></font><font style="font-size:10pt;font-family:'Times New Roman'">&#9744;</font></p></td>
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<p style="margin-top:9pt;margin-bottom:0pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;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></tr></table></div>
<p style="margin-top:6pt;margin-bottom:12pt;text-indent:0%;font-size:9pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Securities registered pursuant to Section 12(b) of the Act:</p>
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<p style="text-align:center;margin-bottom:12pt;margin-top:0pt;margin-left:0pt;;text-indent:36pt;;font-size:9pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Title of each class</p></td>
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<p style="text-align:center;margin-bottom:12pt;margin-top:0pt;margin-left:0pt;;text-indent:36pt;;font-size:9pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Name of each exchange on which registered</p></td>
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<p style="text-align:center;margin-bottom:12pt;margin-top:0pt;margin-left:0pt;;text-indent:36pt;;font-size:9pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Common</p></td>
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<p style="text-align:center;margin-bottom:12pt;margin-top:0pt;margin-left:0pt;;text-indent:36pt;;font-size:9pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">ABIO</p></td>
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<p style="text-align:center;margin-bottom:12pt;margin-top:0pt;margin-left:0pt;;text-indent:36pt;;font-size:9pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Nasdaq Capital Market</p></td>
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<p style="margin-top:9pt;margin-bottom:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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).</p>
<p style="margin-top:9pt;margin-bottom:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Emerging growth company&#160;<font style="font-family:'Times New Roman';"><font style="font-size:10pt;font-family:'Times New Roman'">&#9744;</font></font></p>
<p style="margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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.&#160;<font style="font-family:'Times New Roman';"><font style="font-size:10pt;font-family:'Times New Roman'">&#9744;</font></font></p>
<p style="text-align:justify;margin-top:4pt;border-top:Solid 0.75pt #000000;padding-top:0pt;line-height:1pt;margin-bottom:0pt;text-indent:0%;font-size:4pt;font-family:Times New Roman;">&nbsp;</p>
<p style="text-align:justify;border-top:Solid 1pt;padding-top:1pt;margin-top:1pt;line-height:1pt;margin-bottom:0pt;text-indent:0%;font-size:4pt;font-family:Times New Roman;">&nbsp;</p>
<p style="margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&nbsp;</p>
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<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;">Section&#160;8 &#8212; Other Events</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:4.5pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#160;</p>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;font-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;">Item&#160;8.01.</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;font-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;"> Other Events. </p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:12pt;font-family:Times New Roman;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">On December 15, 2020, ARCA biopharma, Inc., or the Company, announced that the first patients have been enrolled in<font style="font-size:12pt;"> </font>ASPEN&#8209;COVID&#8209;19, the Phase 2b clinical trial evaluating rNAPc2 (AB201) as a potential treatment for patients hospitalized with COVID-19.&nbsp;&nbsp;The first patient was enrolled at the University of Colorado Hospital on December 10, 2020, with a total of 5 patients randomized to date. The Company currently anticipates topline trial data from this Phase 2b clinical trial in the second quarter of 2021. The press release related to these items is filed as Exhibit&#160;99.1 hereto, the contents of which are incorporated herein by reference<font style="font-size:12pt;">.</font></p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:12pt;font-family:Times New Roman;">&nbsp;</p>
<p style="margin-top:13pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;">Section 9 &#8212; Financial Statements and Exhibits </p>
<p style="margin-top:4pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;">Item 9.01. Financial Statements and Exhibits. </p>
<p style="margin-top:4pt;margin-bottom:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">(d) Exhibits. </p>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">99.1</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-size:12pt;">&nbsp;</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><a href="abio-ex991_6.htm"><font style="text-decoration:underline;">Press Release titled &#8220;ARCA biopharma Announces First Patients Enrolled in ASPEN&#8209;COVID&#8209;19 Phase&#160;2b Clinical Trial Evaluating rNAPc2 (AB201) as a Potential Treatment for COVID-19&#8221; dated December&#160;15,&#160;2020</font></a><font style="font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">.</font></p></td>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;">SIGNATURES</p>
<p style="text-align:justify;margin-top:12pt;margin-bottom:0pt;text-indent:4.54%;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. </p>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">By:</p></td>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">/s/ Brian L. Selby</p></td>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:1pt;">&nbsp;</p>
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<p style="text-align:left;margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-size:12pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;"><img src="gr2au4neejg2000001.jpg" title="" alt="" style="width:204px;height:70px;"></p>
<p style="text-align:left;margin-top:12pt;margin-bottom:0pt;font-weight:bold;font-size:12pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;text-indent:48.89%;"><br />&nbsp;</p>
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<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>
<p style="text-align:center;margin-bottom:12pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:12pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">ARCA biopharma Announces First Patients Enrolled in ASPEN-COVID-19 Phase 2b Clinical Trial Evaluating rNAPc2 (AB201) as a Potential Treatment for COVID&#8209;19</p>
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<p style="text-align:left;margin-bottom:4pt;margin-top:0pt;font-weight:normal;font-style:normal;color:#auto;font-size:12pt;font-family:Times New Roman;text-transform:none;font-variant: normal;letter-spacing:0pt;"><font style="font-weight:normal;font-style:normal;text-decoration:none;Background-color:#auto;color:#auto;font-size:12pt;font-family:Times New Roman;text-transform:none;font-variant: normal;letter-spacing:0pt;">-</font></p></td>
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<p style="text-align:left;margin-bottom:4pt;margin-top:0pt;font-weight:normal;font-style:normal;color:#auto;text-transform:none;font-variant: normal;letter-spacing:0pt;font-family:Times New Roman;font-size:12pt;"><font style="Background-color:#auto;text-decoration:none;"></font><font style="color:#000000;">rNAPc2 development focused on unmet need for treatments in hospitalized COVID-19 patients, including after availability of vaccines</font></p></td></tr></table></div>
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<p style="text-align:left;margin-bottom:4pt;margin-top:0pt;font-weight:normal;font-style:normal;color:#auto;font-size:12pt;font-family:Times New Roman;text-transform:none;font-variant: normal;letter-spacing:0pt;"><font style="font-weight:normal;font-style:normal;text-decoration:none;Background-color:#auto;color:#auto;font-size:12pt;font-family:Times New Roman;text-transform:none;font-variant: normal;letter-spacing:0pt;">-</font></p></td>
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<p style="text-align:left;margin-bottom:4pt;margin-top:0pt;font-weight:normal;font-style:normal;color:#auto;text-transform:none;font-variant: normal;letter-spacing:0pt;font-family:Times New Roman;font-size:12pt;"><font style="Background-color:#auto;text-decoration:none;"></font><font style="color:#000000;">rNAPc2 is the only novel compound being developed for COVID&#8209;19 Associated Coagulopathy </font></p></td></tr></table></div>
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<p style="text-align:left;margin-bottom:4pt;margin-top:0pt;font-weight:normal;font-style:normal;color:#auto;font-size:12pt;font-family:Times New Roman;text-transform:none;font-variant: normal;letter-spacing:0pt;"><font style="font-weight:normal;font-style:normal;text-decoration:none;Background-color:#auto;color:#auto;font-size:12pt;font-family:Times New Roman;text-transform:none;font-variant: normal;letter-spacing:0pt;">-</font></p></td>
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<p style="text-align:left;margin-bottom:4pt;margin-top:0pt;font-weight:normal;font-style:normal;color:#auto;text-transform:none;font-variant: normal;letter-spacing:0pt;font-family:Times New Roman;font-size:12pt;"><font style="Background-color:#auto;text-decoration:none;"></font><font style="color:#000000;">Topline trial data anticipated in the second quarter of 2021</font></p></td></tr></table></div>
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<p style="text-align:left;margin-bottom:4pt;margin-top:0pt;font-weight:normal;font-style:normal;color:#auto;font-size:12pt;font-family:Times New Roman;text-transform:none;font-variant: normal;letter-spacing:0pt;"><font style="font-weight:normal;font-style:normal;text-decoration:none;Background-color:#auto;color:#auto;font-size:12pt;font-family:Times New Roman;text-transform:none;font-variant: normal;letter-spacing:0pt;">-</font></p></td>
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<p style="text-align:left;margin-bottom:4pt;margin-top:0pt;font-weight:normal;font-style:normal;color:#auto;text-transform:none;font-variant: normal;letter-spacing:0pt;font-family:Times New Roman;font-size:12pt;"><font style="Background-color:#auto;text-decoration:none;"></font><font style="color:#000000;">Data from this development program will also inform potential development in additional RNA virus-associated diseases</font></p></td></tr></table></div>
<p style="margin-bottom:16pt;text-align:justify;margin-top:0pt;text-indent:0%;font-style:italic;font-size:12pt;font-family:Times New Roman;font-weight:normal;text-transform:none;font-variant: normal;">Westminster, CO, December 15, 2020<font style="font-style:normal;"> &#8211; ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, today announced that the first patients have been enrolled in ASPEN-COVID-19, the Phase 2b clinical trial evaluating rNAPc2 (AB201) as a potential treatment for patients hospitalized with COVID-19.&nbsp;&nbsp;The first patient was enrolled at the University of Colorado Hospital on December 10, 2020, with a total of 5 patients randomized to date.&nbsp;&nbsp;The Company currently anticipates topline trial data from this Phase 2b clinical trial in the second quarter of 2021.</font></p>
<p style="margin-bottom:16pt;text-align:justify;margin-top:0pt;text-indent:0%;font-size:12pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#8220;There is a critical need for safe, efficacious treatments in hospitalized COVID-19 patients, and we believe this need will continue even with potentially effective vaccines available,&#8221; said Dr. Michael Bristow, ARCA&#8217;s President and Chief Executive Officer, who is also an American Heart Association (AHA) funded COVID-19 investigator. "We believe rNAPc2&#8217;s combination of anticoagulant, anti-inflammatory and antiviral effects may favorably impact clinical recovery of patients hospitalized with COVID-19, and we look forward to completing the ASPEN-COVID-19 trial evaluating rNAPc2&#8217;s potential efficacy in this patient population."</p>
<p style="margin-bottom:16pt;text-align:justify;margin-top:0pt;text-indent:0%;font-size:12pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">ASPEN-COVID-19 Phase 2b is a randomized, multi-center, international clinical trial evaluating two dose regimens of rNAPc2 versus heparin prescribed per local standard of care in approximately 100 hospitalized SARS-CoV-2 positive patients that also have an elevated D-dimer level.&nbsp;&nbsp;The primary endpoint of the trial is safety and change in D-dimer level from baseline to Day 8 relative to standard of care heparin.&nbsp;&nbsp;D-dimer is a biomarker commonly used for assessing coagulation activation, which is elevated in approximately 50% of hospitalized COVID-19 patients and is directly associated with adverse clinical outcomes.</p>
<p style="margin-bottom:16pt;text-align:justify;margin-top:0pt;text-indent:0%;font-size:12pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Dr. Wolfram Ruf, Scientific Director of the Center for Thrombosis and Hemostasis at the Johannes Gutenberg University Medical Center Mainz, Germany, and Professor at Scripps Research, La Jolla, CA, commented, &#8220;The clinical course of some patients with COVID-19 is complicated by a virus-triggered coagulopathy that includes thrombotic events and inflammatory processes, thought to be mediated in part by tissue factor production.&nbsp;&nbsp;Because rNAPc2 is a potent tissue factor inhibitor, it has anticoagulant with anti-inflammatory and antiviral properties.&nbsp;&nbsp;With its properties in modulating the tissue factor pathway, rNAPc2 has the potential to be a uniquely beneficial therapy for patients hospitalized with COVID-19, and potentially other RNA virus associated diseases as well.&#8221;</p>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:1pt;">&nbsp;</p>
<p style="margin-bottom:16pt;text-align:justify;margin-top:0pt;text-indent:0%;font-size:12pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><font style="font-size:12pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Dr. Marc </font><font style="font-size:12pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Bonaca</font><font style="font-size:12pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> MD MPH, Executive Director of </font><font style="font-size:12pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">CPC Clinical Research</font><font style="font-size:12pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> and the Director of Vascular Research at the </font><font style="font-size:12pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">University of Colorado School of Medicine</font><font style="font-size:12pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">, Aurora, Colorado commented, &#8220;Coagulopathy has </font><font style="font-size:12pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">now </font><font style="font-size:12pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">been well described as a core malignant feature of COVID-19</font><font style="font-size:12pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">,</font><font style="font-size:12pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> as well as other severe viral infections, but we are learning that just simply increasing the intensity of anticoagulation using traditional therapies may not be the optimal approach both for efficacy and for bleeding risk. Targeted inhibition of tissue factor, which plays a key role in the complex interplay of coagulation, inflammation, and infection, holds promise to </font><font style="font-size:12pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">potentially </font><font style="font-size:12pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">improve outcomes. The ASPEN-COVID-19 study will provide critical data as to the role of </font><font style="font-size:12pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">rNAPc2</font><font style="font-size:12pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> in this setting as well as other viral and inflammatory conditions characterized by tissue factor mediated coagulopathy.</font><font style="font-size:12pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#8221;</font></p>
<p style="margin-bottom:16pt;text-align:justify;margin-top:0pt;text-indent:0%;font-size:12pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The U.S. Food and Drug Administration (FDA) has designated the investigation of rNAPc2 as a potential treatment for COVID-19 as a Fast Track development program.&nbsp;&nbsp;ARCA believes that rNAPc2 is the only anticoagulant class new chemical entity in development for COVID-19.</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:12pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">About rNAPc2 (AB201)</p>
<p style="margin-bottom:16pt;text-align:justify;margin-top:0pt;text-indent:0%;font-size:12pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">rNAPC2 is a small recombinant protein being developed as a potential treatment for RNA virus- associated diseases, initially focusing on COVID-19.&nbsp;&nbsp;rNAPC2 is a potent, selective inhibitor of tissue factor (TF), which has been identified as playing a central role in the inflammatory response to viral infections and in the process of viral dissemination. Its unique mechanism of action gives rNAPC2 a combination of anti-coagulant, anti-inflammatory and anti-viral properties, and therefore the potential to be effective in addressing the impact of viral infections from multiple pathways.&nbsp;&nbsp;rNAPc2 has previously undergone Phase 1 and Phase 2 testing in more than 700 patients, including in clinical studies for prevention of venous and arterial thrombosis, where it showed efficacy in inhibiting the TF pathway and was well tolerated at therapeutic doses. Recent research suggests that the disease syndrome caused by coronavirus may have much in common with other severe infections in which the infection process causes inappropriate activation of the coagulation system and other aspects of the immune response, resulting in serious complications.&nbsp;&nbsp;Recent mechanistic discoveries, as well as prior data from studies in non-human primates (NHPs) given lethal doses of Ebola or Marburg filoviruses demonstrating morbidity and mortality reductions, decreases in inflammatory biomarkers and reduction in viral load, indicate that rNAPC2 may have important antiviral and anti-inflammatory activity in addition to its anticoagulant effects. The Company believes that collectively these observations provide a strong rationale for investigating rNAPC2 as a treatment for COVID-19 and other RNA virus associated diseases. </p>
<p style="margin-bottom:16pt;text-align:justify;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:12pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">About ARCA biopharma</p>
<p style="margin-bottom:16pt;text-align:justify;margin-top:0pt;text-indent:0%;font-size:12pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">ARCA biopharma is dedicated to developing genetically targeted therapies for cardiovascular diseases through a precision medicine approach to drug development. ARCA is developing rNAPc2 as a potential treatment for diseases caused by RNA viruses, initially focusing on COVID-19. ARCA is also developing Gencaro<sup style="font-size:85%;line-height:120%;vertical-align:top">TM</sup> (bucindolol hydrochloride), an investigational, pharmacologically unique beta-blocker and mild vasodilator, as a potential pharmacogenetic treatment for atrial fibrillation in patients with heart failure.&nbsp;&nbsp;For more information, please visit <font style="text-decoration:underline;">www.arcabio.com</font> or follow the Company on <font style="text-decoration:underline;">LinkedIn</font>. </p>
<p style="margin-top:12pt;text-align:justify;margin-bottom:0pt;text-indent:0%;font-size:1pt;">&nbsp;</p>
<hr style="page-break-after:always;width:100%;">
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:1pt;">&nbsp;</p>
<p style="margin-bottom:16pt;text-align:justify;margin-top:0pt;font-size:12pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"></p>
<p style="margin-bottom:16pt;text-align:justify;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:12pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Safe Harbor Statement</p>
<p style="margin-bottom:16pt;text-align:justify;margin-top:0pt;text-indent:0%;font-style:italic;font-size:12pt;font-family:Times New Roman;font-weight:normal;text-transform:none;font-variant: normal;">This press release contains "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding potential future development plans for rNAPc2 (AB201), the expected features and characteristics of rNAPc2, the anticipated development timeline for rNAPc2, rNAPc2&#8217;s potential to treat COVID-19, or any other RNA virus associated disease, whether rNAPc2 is the only anticoagulant class new chemical entity in development for COVID-19 Associated Coagulopathy and the potential future treatment options and needs for patients with COVID-19<font style="font-size:11.5pt;">. </font>Such statements are based on management's current expectations and involve risks and uncertainties.&nbsp;&nbsp;Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: ARCA&#8217;s financial resources and whether they will be sufficient to meet its business objectives and operational requirements; ARCA may not be able to raise sufficient capital on acceptable terms, or at all, to continue development of rNAPc2 or to otherwise continue operations in the future; results of earlier clinical trials may not be confirmed in future trials; the protection and market exclusivity provided by ARCA&#8217;s intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes.&nbsp;&nbsp;These and other factors are identified and described in more detail in ARCA&#8217;s filings with the Securities and Exchange Commission, including without limitation ARCA&#8217;s annual report on Form 10-K for the year ended December&#160;31,&#160;2019, and subsequent filings. ARCA disclaims any intent or obligation to update these forward-looking statements.</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:12pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Investor &amp; Media Contact:</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:12pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Derek Cole</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:12pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">720.940.2163</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:12pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><font style="text-decoration:underline;">derek.cole@arcabio.com</font></p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;color:#000000;font-size:12pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">###</p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>
<p style="margin-top:12pt;text-align:justify;margin-bottom:0pt;text-indent:0%;font-size:1pt;">&nbsp;</p></body>
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