<SEC-DOCUMENT>0001564590-20-044129.txt : 20200921
<SEC-HEADER>0001564590-20-044129.hdr.sgml : 20200921
<ACCEPTANCE-DATETIME>20200921163629
ACCESSION NUMBER:		0001564590-20-044129
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20200921
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20200921
DATE AS OF CHANGE:		20200921

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:		201186877

	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_20200921.htm
<DESCRIPTION>8-K
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:18pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">SECURITIES AND EXCHANGE COMMISSION</p>
<p style="text-align:center;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;">WASHINGTON, D.C. 20549 </p>
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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;">September 21, 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;">(State or Other Jurisdiction</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;">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;">11080 CirclePoint Road, Suite 140, 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;">80020</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:0pt;;font-size:9pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Trading Symbol(s)</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="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<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-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;">On September 21, 2020, ARCA biopharma, Inc., or the Company, announced it has submitted an Investigational New Drug, or IND, application with the U.S. Food and Drug Administration, or FDA, under the Coronavirus Treatment Acceleration Program for AB201 as a potential treatment for patients with COVID-19. Pending FDA feedback, the Company anticipates initiating the Phase 2b portion of a sequential Phase 2b/3 clinical evaluation of AB201 as early as the fourth quarter of this year. The press release related to these items is filed as Exhibit&#160;99.1 hereto, the contents of which are incorporated herein by reference. </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;">&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;">&nbsp;</p></td>
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<p style="text-align:center;border-bottom:Solid 0.75pt #000000;padding-bottom:0pt;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;">Exhibit Number</p></td>
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<p style="border-bottom:Solid 0.75pt #000000;padding-bottom:0pt;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;">Description</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;">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 Submission of IND Application to U.S. FDA for AB201 as a Potential Treatment for COVID-19&#8221; dated September 21, 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="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;"><br /></p>
<p style="margin-top:12pt;line-height:10pt;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>
<p style="line-height:10pt;margin-bottom:0pt;margin-top: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="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;"><a name="_AEIOULastRenderedPageBreakAEIOU2"></a><font style="font-weight:bold;font-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;">SIGNATURES</font></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;">Dated: September 21, 2020</p></td>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;;font-size:12pt;">&nbsp;</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;">&nbsp;</p></td>
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<p style="text-align:justify;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;">ARCA biopharma, Inc.</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;">&nbsp;</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;">(Registrant)</p></td>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-size:12pt;">&nbsp;</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;">&nbsp;</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;">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;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:10pt;">&nbsp;</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;">Name:</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;">Brian L. Selby</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;">&nbsp;</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;">&nbsp;</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;">Title:</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;">Vice President, Finance and Chief Accounting Officer</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>
<p style="text-align:right;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;">Exhibit 99.1</p>
<p style="text-align:right;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>
<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="geqaz1ntd5f2000001.jpg" title="" alt="" style="width:203px;height:69px;"></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>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</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:center;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;">ARCA biopharma Announces Submission of IND Application to U.S. FDA for AB201 as a Potential Treatment for <font style="text-transform:uppercase;">covid-19</font></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-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, September 21, 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 it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) under the Coronavirus Treatment Acceleration Program (CTAP) to evaluate AB201 for the treatment of patients hospitalized with COVID-19.&nbsp;&nbsp;Pending FDA feedback, ARCA anticipates initiating the Phase 2b portion of a sequential Phase 2b/3 clinical evaluation of AB201 as early as the fourth quarter of this year.</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;">Dr. Michael Bristow, ARCA&#8217;s President and Chief Executive Officer, commented, &#8220;This IND submission is a key milestone in the clinical development of AB201.&nbsp;&nbsp;With what we believe to be a strong scientific rationale, safety data from prior human clinical trials in over 700 patients, and a well-defined regulatory pathway, we believe AB201 has potential as a therapeutic treatment for COVID-19, as well as other RNA virus associated diseases.&#8221; </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 AB201 (rNAPc2)<font style="font-weight:normal;"> </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;">AB201 is a small recombinant protein being developed as a potential treatment for RNA virus- associated disease, initially focusing on COVID-19.&nbsp;&nbsp;AB201 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 AB210 a combination of anti-coagulant, immuno-modulation and anti-viral properties, and therefore the potential to be effective in addressing the pathologies caused by viral infections from multiple aspects.&nbsp;&nbsp;AB201 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 AB201 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 AB201 as a treatment for COVID-19 and other RNA virus associated diseases.</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;text-indent:0%;font-weight:bold;font-size:12pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;"><a name="_AEIOULastRenderedPageBreakAEIOU2"></a><font style="font-weight:bold;font-size:12pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">About ARCA biopharma</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;">ARCA biopharma is dedicated to developing genetically targeted therapies for cardiovascular diseases through a precision medicine approach to drug development. ARCA is developing AB201 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 treatment for atrial fibrillation in heart failure patients. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically targeted atrial fibrillation (AF) prevention treatment. The U.S. FDA has granted the Gencaro development program Fast Track designation and a Special Protocol Assessment (SPA) agreement. 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-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 AB201 and Gencaro, the expected features and characteristics of AB201 and Gencaro, including the potential for genetic variations to predict individual patient response to Gencaro, Gencaro&#8217;s potential to treat atrial fibrillation, AB201&#8217;s potential to treat COVID-19 or any other RNA virus associated disease, future treatment options for patients with COVID-19, and the potential for Gencaro to be the first genetically targeted AF prevention treatment<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 AB201 or Gencaro 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>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
