<?xml version='1.0' encoding='UTF-8'?>

      <!-- iXBRL document created with: Toppan Merrill Bridge iXBRL 9.6.8042.36810 -->
      <!-- Based on: iXBRL 1.1 -->
      <!-- Created on: 1/25/2022 10:17:34 AM -->
      <!-- iXBRL Library version: 1.0.8042.36816 -->
      <!-- iXBRL Service Job ID: f0439d18-0cf2-437d-987b-697153cb27a5 -->

  <html xmlns:dei="http://xbrl.sec.gov/dei/2020-01-31" xmlns="http://www.w3.org/1999/xhtml" xmlns:link="http://www.xbrl.org/2003/linkbase" xmlns:capr="http://capricor.com/20220124" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xbrldt="http://xbrl.org/2005/xbrldt" xmlns:xs="http://www.w3.org/2001/XMLSchema-instance" xmlns:ixt-sec="http://www.sec.gov/inlineXBRL/transformation/2015-08-31" xmlns:ixt="http://www.xbrl.org/inlineXBRL/transformation/2015-02-26" xmlns:ix="http://www.xbrl.org/2013/inlineXBRL" xmlns:ref="http://www.xbrl.org/2006/ref" xmlns:xbrli="http://www.xbrl.org/2003/instance"><head><meta http-equiv="content-type" content="text/html" /><title></title></head><body><div style="margin-top:30pt;"></div><div style="display:none;"><ix:header><ix:hidden><ix:nonNumeric contextRef="Duration_1_24_2022_To_1_24_2022_P3L-cmD3wUmJzWnjpHR7jg" name="dei:EntityCentralIndexKey" id="Tc_95d_5GzFF0y-FYUT6xY_yg_1_1">0001133869</ix:nonNumeric><ix:nonNumeric contextRef="Duration_1_24_2022_To_1_24_2022_P3L-cmD3wUmJzWnjpHR7jg" name="dei:AmendmentFlag" id="Tc_0SA6hvv4Z0-0_w8yQUY57Q_2_1">false</ix:nonNumeric></ix:hidden><ix:references><link:schemaRef xlink:href="capr-20220124.xsd" xlink:type="simple"></link:schemaRef></ix:references><ix:resources><xbrli:context id="Duration_1_24_2022_To_1_24_2022_P3L-cmD3wUmJzWnjpHR7jg"><xbrli:entity><xbrli:identifier scheme="http://www.sec.gov/CIK">0001133869</xbrli:identifier></xbrli:entity><xbrli:period><xbrli:startDate>2022-01-24</xbrli:startDate><xbrli:endDate>2022-01-24</xbrli:endDate></xbrli:period></xbrli:context></ix:resources></ix:header></div><div style="max-width:100%;padding-left:8.82%;padding-right:8.82%;position:relative;"><div style="clear:both;max-width:100%;position:relative;min-height:11.5pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;padding-bottom:1pt;padding-top:1pt;text-align:center;border-bottom:1.0pt solid #000000;border-top:3.0pt solid #000000;margin:0pt;"><span style="font-size:1pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><span style="font-size:7pt;visibility:hidden;">&#8203;</span></p><a id="_e4dba696_8f19_46d6_b33b_fd82b6a13fcc"></a><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><b style="font-size:18pt;font-weight:bold;">UNITED STATES</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><b style="font-size:18pt;font-weight:bold;">SECURITIES AND EXCHANGE COMMISSION</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><b style="font-weight:bold;">Washington, D.C. 20549</b></p><div style="font-family:'Times New Roman','Times','serif';font-size:10.0pt;margin-bottom:0pt;margin-top:0pt;min-height:1.19em;position:relative;width:100%;"><div style="background-color:#000000;height:1pt;position:relative;top:0.6em;width:25.0%;border:none;margin:0 auto;"></div></div><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><span style="font-size:7pt;margin-bottom:5pt;margin-top:5pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:18pt;text-align:center;margin:0pt;"><b style="font-weight:bold;">FORM </b><ix:nonNumeric contextRef="Duration_1_24_2022_To_1_24_2022_P3L-cmD3wUmJzWnjpHR7jg" name="dei:DocumentType" id="Narr_UKRYiF7lfUyy64m1DAwZwQ"><b style="font-weight:bold;">8-K</b></ix:nonNumeric></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><span style="font-size:7pt;margin-bottom:5pt;margin-top:5pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><b style="font-weight:bold;">CURRENT REPORT</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><b style="font-weight:bold;">Pursuant to Section 13 or 15(d) of</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><b style="font-weight:bold;">The Securities Exchange Act of 1934</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><span style="font-size:7pt;margin-bottom:5pt;margin-top:5pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;">Date of Report (Date of earliest event reported)</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><span style="font-size:7pt;margin-bottom:5pt;margin-top:5pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><ix:nonNumeric contextRef="Duration_1_24_2022_To_1_24_2022_P3L-cmD3wUmJzWnjpHR7jg" format="ixt:datemonthdayyearen" name="dei:DocumentPeriodEndDate" id="Narr_Jx7J49kISEyQBv7oSDXSVQ"><b style="font-weight:bold;">January 24, 2022</b></ix:nonNumeric></p><div style="font-family:'Times New Roman','Times','serif';font-size:6.0pt;margin-bottom:0pt;margin-top:0pt;min-height:1.19em;position:relative;width:100%;"><div style="background-color:#000000;height:1pt;position:relative;top:0.6em;width:25.0%;border:none;margin:0 auto;"></div></div><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><span style="font-size:7pt;margin-bottom:5pt;margin-top:5pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:24pt;text-align:center;margin:0pt;"><ix:nonNumeric contextRef="Duration_1_24_2022_To_1_24_2022_P3L-cmD3wUmJzWnjpHR7jg" name="dei:EntityRegistrantName" id="Narr_LgKpUUymtki5VcUpUYm_ZQ"><b style="font-weight:bold;">CAPRICOR THERAPEUTICS, INC.</b></ix:nonNumeric><b style="font-weight:bold;"> </b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><b style="font-weight:bold;">(Exact name of Registrant as Specified in its Charter) </b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;text-indent:0pt;margin:0pt;"><span style="font-size:7pt;visibility:hidden;">&#8203;</span></p><a id="_1f2dae61_4096_42f8_b63f_50791ccc1987"></a><a id="Tc_WTGGTX2GCEaKFX9gpLUk0w_2_0"></a><a id="Tc_sroFJHbSXU6vFYRp75WU4A_2_2"></a><a id="Tc_v6dysB2z1kqma-uhdPAlFA_2_4"></a><table style="border-collapse:collapse;font-size:16pt;height:max-content;padding-left:0pt;padding-right:0pt;width:100%;"><tr style="height:1pt;"><td style="vertical-align:bottom;width:31.99%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:8pt;margin:0pt;"><b style="font-weight:bold;">&#160;&#160;&#160;&#160;</b></p></div></div></td><td style="vertical-align:bottom;width:1.99%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:1pt;visibility:hidden;">&#8203;</span></p></div></div></td><td style="vertical-align:bottom;width:32%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;width:2%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:1pt;visibility:hidden;">&#8203;</span></p></div></div></td><td style="vertical-align:bottom;width:32%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td></tr><tr><td style="vertical-align:bottom;width:31.99%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><ix:nonNumeric contextRef="Duration_1_24_2022_To_1_24_2022_P3L-cmD3wUmJzWnjpHR7jg" format="ixt-sec:stateprovnameen" name="dei:EntityIncorporationStateCountryCode" id="Tc_5HM26kT2zUSgqPfmp-9QuA_1_0"><b style="font-weight:bold;">Delaware</b></ix:nonNumeric></p></td><td style="vertical-align:bottom;width:1.99%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:8pt;text-align:justify;margin:0pt;"><b style="font-weight:bold;">&#160;&#160;&#160;&#160;</b></p></td><td style="vertical-align:bottom;width:32%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><ix:nonNumeric contextRef="Duration_1_24_2022_To_1_24_2022_P3L-cmD3wUmJzWnjpHR7jg" name="dei:EntityFileNumber" id="Tc_-zSMsTXWFEa_DiipT9-q8A_1_2"><b style="font-weight:bold;">001-34058</b></ix:nonNumeric></p></td><td style="vertical-align:bottom;width:2%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:8pt;text-align:center;margin:0pt;"><b style="font-weight:bold;">&#160;&#160;&#160;&#160;</b></p></td><td style="vertical-align:bottom;width:32%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><ix:nonNumeric contextRef="Duration_1_24_2022_To_1_24_2022_P3L-cmD3wUmJzWnjpHR7jg" name="dei:EntityTaxIdentificationNumber" id="Tc_xlRxe1940EO1EeHnRlh4Qw_1_4"><b style="font-weight:bold;">88-0363465</b></ix:nonNumeric></p></td></tr><tr><td style="vertical-align:bottom;width:31.99%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><b style="font-weight:bold;">(State or other jurisdiction</b><b style="font-weight:bold;"><br /></b><b style="font-weight:bold;">of incorporation)</b></p></td><td style="vertical-align:bottom;width:1.99%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt;"><span style="font-weight:bold;visibility:hidden;">&#8203;</span></p></td><td style="vertical-align:bottom;width:32%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><b style="font-weight:bold;">(Commission</b><b style="font-weight:bold;"><br /></b><b style="font-weight:bold;">File Number)</b></p></td><td style="vertical-align:bottom;width:2%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><span style="font-weight:bold;visibility:hidden;">&#8203;</span></p></td><td style="vertical-align:bottom;width:32%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><b style="font-weight:bold;">(I.R.S. Employer</b><b style="font-weight:bold;"><br /></b><b style="font-weight:bold;">Identification No.)</b></p></td></tr></table><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:5pt;visibility:hidden;">&#8203;</span></p><table style="border-collapse:collapse;font-size:16pt;height:max-content;padding-left:0pt;padding-right:0pt;width:100%;"><tr style="height:1pt;"><td style="vertical-align:bottom;width:48.99%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:8pt;margin:0pt;"><b style="font-weight:bold;">&#160;&#160;&#160;&#160;</b></p></div></div></td><td style="vertical-align:bottom;width:2%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;width:48.99%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td></tr><tr><td style="vertical-align:bottom;width:48.99%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><ix:nonNumeric contextRef="Duration_1_24_2022_To_1_24_2022_P3L-cmD3wUmJzWnjpHR7jg" name="dei:EntityAddressAddressLine1" id="Narr_eGcEeendekWXctRFkzzblg"><b style="font-weight:bold;">8840 Wilshire Blvd.</b></ix:nonNumeric><b style="font-weight:bold;">, </b><ix:nonNumeric contextRef="Duration_1_24_2022_To_1_24_2022_P3L-cmD3wUmJzWnjpHR7jg" name="dei:EntityAddressAddressLine2" id="Narr_1YDP_vnT_Uu2w5ucbjQjpg"><b style="font-weight:bold;">2nd Floor</b></ix:nonNumeric><b style="font-weight:bold;">, </b><ix:nonNumeric contextRef="Duration_1_24_2022_To_1_24_2022_P3L-cmD3wUmJzWnjpHR7jg" name="dei:EntityAddressCityOrTown" id="Narr_dq-YzgxwnEe9j0bqVhflkA"><b style="font-weight:bold;">Beverly Hills</b></ix:nonNumeric><b style="font-weight:bold;">, </b><ix:nonNumeric contextRef="Duration_1_24_2022_To_1_24_2022_P3L-cmD3wUmJzWnjpHR7jg" name="dei:EntityAddressStateOrProvince" id="Narr_fwXFpoC_rECDkuSdOIIPGg"><b style="font-weight:bold;">CA</b></ix:nonNumeric><b style="font-weight:bold;"><br /></b><b style="font-weight:bold;">(Address of principal executive offices)</b></p></td><td style="vertical-align:bottom;width:2%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:8pt;text-align:justify;margin:0pt;"><b style="font-weight:bold;">&#160;&#160;&#160;&#160;</b></p></td><td style="vertical-align:bottom;width:48.99%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><ix:nonNumeric contextRef="Duration_1_24_2022_To_1_24_2022_P3L-cmD3wUmJzWnjpHR7jg" name="dei:EntityAddressPostalZipCode" id="Narr_h0s1nGqyN0iwQoyDNH2Q2g"><b style="font-weight:bold;">90211</b></ix:nonNumeric><b style="font-weight:bold;"><br /></b><b style="font-weight:bold;">(Zip Code)</b></p></td></tr></table><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><b style="font-weight:bold;">(</b><ix:nonNumeric contextRef="Duration_1_24_2022_To_1_24_2022_P3L-cmD3wUmJzWnjpHR7jg" name="dei:CityAreaCode" id="Narr_s9nJiq27x0qDljbt8_cu0g"><b style="font-weight:bold;">310</b></ix:nonNumeric><b style="font-weight:bold;">) </b><ix:nonNumeric contextRef="Duration_1_24_2022_To_1_24_2022_P3L-cmD3wUmJzWnjpHR7jg" name="dei:LocalPhoneNumber" id="Narr_5bQfmMHnr0qkLWLgFp9dAQ"><b style="font-weight:bold;">358-3200</b></ix:nonNumeric></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><b style="font-weight:bold;">(Registrant&#8217;s telephone number, including area code) </b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><span style="font-size:7pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><b style="font-weight:bold;">Not Applicable</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><b style="font-weight:bold;">(Former name or former address, if changed since last report) </b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:7pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:7pt;margin-bottom:5pt;margin-top:5pt;visibility:hidden;">&#8203;</span></p><table style="border-collapse:collapse;border:0;"><tr><td style="vertical-align:text-top;white-space:nowrap;width:18pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin-bottom:0pt;margin-top:0pt;"><ix:nonNumeric contextRef="Duration_1_24_2022_To_1_24_2022_P3L-cmD3wUmJzWnjpHR7jg" format="ixt-sec:boolballotbox" name="dei:WrittenCommunications" id="Narr_NvurOl8gpEGTBYI44MxU9g"><span style="font-family:'Wingdings';">&#9744;</span></ix:nonNumeric></p></td><td style="padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin-bottom:0pt;margin-top:0pt;">Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)</p></td></tr></table><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;padding-left:18pt;text-indent:-18pt;margin:0pt;"><span style="font-size:7pt;visibility:hidden;">&#8203;</span></p><table style="border-collapse:collapse;border:0;"><tr><td style="vertical-align:text-top;white-space:nowrap;width:18pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin-bottom:0pt;margin-top:0pt;"><ix:nonNumeric contextRef="Duration_1_24_2022_To_1_24_2022_P3L-cmD3wUmJzWnjpHR7jg" format="ixt-sec:boolballotbox" name="dei:SolicitingMaterial" id="Narr_WbNGwToVWE-NnJyM-s7GKg"><span style="font-family:'Wingdings';">&#9744;</span></ix:nonNumeric></p></td><td style="padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin-bottom:0pt;margin-top:0pt;">Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)</p></td></tr></table><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;padding-left:18pt;text-indent:-18pt;margin:0pt;"><span style="font-size:7pt;visibility:hidden;">&#8203;</span></p><table style="border-collapse:collapse;border:0;"><tr><td style="vertical-align:text-top;white-space:nowrap;width:18pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin-bottom:0pt;margin-top:0pt;"><ix:nonNumeric contextRef="Duration_1_24_2022_To_1_24_2022_P3L-cmD3wUmJzWnjpHR7jg" format="ixt-sec:boolballotbox" name="dei:PreCommencementTenderOffer" id="Narr_XiqehS1Zz0qlEqWgE5NbXA"><span style="font-family:'Wingdings';">&#9744;</span></ix:nonNumeric></p></td><td style="padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin-bottom:0pt;margin-top:0pt;">Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))</p></td></tr></table><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;padding-left:18pt;text-indent:-18pt;margin:0pt;"><span style="font-size:7pt;visibility:hidden;">&#8203;</span></p><table style="border-collapse:collapse;border:0;"><tr><td style="vertical-align:text-top;white-space:nowrap;width:18pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin-bottom:0pt;margin-top:0pt;"><ix:nonNumeric contextRef="Duration_1_24_2022_To_1_24_2022_P3L-cmD3wUmJzWnjpHR7jg" format="ixt-sec:boolballotbox" name="dei:PreCommencementIssuerTenderOffer" id="Narr_SOYoMrKh1EqHfCsyuppl2w"><span style="font-family:'Wingdings';">&#9744;</span></ix:nonNumeric></p></td><td style="padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin-bottom:0pt;margin-top:0pt;">Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))</p></td></tr></table><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:7pt;margin-bottom:5pt;margin-top:5pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR &#167;230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR &#167;240.12b-2).</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:7pt;margin-bottom:5pt;margin-top:5pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:right;text-indent:324pt;margin:0pt;">Emerging growth company <ix:nonNumeric contextRef="Duration_1_24_2022_To_1_24_2022_P3L-cmD3wUmJzWnjpHR7jg" format="ixt-sec:boolballotbox" name="dei:EntityEmergingGrowthCompany" id="Narr_KgxUgJSwG0693G0nAKel9w"><span style="font-family:'Wingdings';">&#9744;</span></ix:nonNumeric></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt;"><span style="font-size:7pt;margin-bottom:5pt;margin-top:5pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt;">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. <span style="font-family:'Times New Roman';">&#9723;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:7pt;margin-bottom:5pt;margin-top:5pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">Securities registered pursuant to Section&#160;12(b) of the Act:</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:7pt;margin-bottom:5pt;margin-top:5pt;visibility:hidden;">&#8203;</span></p><a id="_1c0baf23_d0e6_4cdb_9993_8a8836d58abc"></a><a id="Tc_n9wX8sI_80KalSl-_rPURQ_1_0"></a><a id="Tc_rdMUfKg4_EepmVe5-qelqg_1_2"></a><a id="Tc_-1mlrYugvE2HGUXhAhmcuA_1_4"></a><a id="Tc_6Hhv2QGQfE-AY51gx-XvRw_2_4"></a><table style="border-collapse:collapse;font-size:16pt;height:max-content;padding-left:0pt;padding-right:0pt;width:100%;"><tr style="height:1pt;"><td style="vertical-align:bottom;width:31.99%;margin:0pt;padding:0pt 0pt 1pt 0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:7pt;margin:0pt;">&#160;&#160;&#160;</p></div></div></td><td style="vertical-align:bottom;width:1.99%;margin:0pt;padding:0pt 0pt 1pt 0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;width:32%;margin:0pt;padding:0pt 0pt 1pt 0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;width:2%;margin:0pt;padding:0pt 0pt 1pt 0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;width:32%;margin:0pt;padding:0pt 0pt 1pt 0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td></tr><tr><td style="vertical-align:bottom;width:31.99%;border-bottom:1.0pt solid #000000;margin:0pt;padding:0pt 0pt 1pt 0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:8pt;text-align:center;margin:0pt;"><b style="font-weight:bold;">Title of Each Class</b></p></td><td style="vertical-align:bottom;width:1.99%;border-bottom:1.0pt solid transparent;margin:0pt;padding:0pt 0pt 1pt 0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:8pt;margin:0pt;"><b style="font-weight:bold;">&#160;&#160;&#160;&#160;</b></p></td><td style="vertical-align:bottom;width:32%;border-bottom:1.0pt solid #000000;margin:0pt;padding:0pt 0pt 1pt 0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:8pt;text-align:center;margin:0pt;"><b style="font-weight:bold;">Trading Symbol(s)</b></p></td><td style="vertical-align:bottom;width:2%;border-bottom:1.0pt solid transparent;margin:0pt;padding:0pt 0pt 1pt 0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:8pt;margin:0pt;"><b style="font-weight:bold;">&#160;&#160;&#160;&#160;</b></p></td><td style="vertical-align:bottom;width:32%;border-bottom:1.0pt solid #000000;margin:0pt;padding:0pt 0pt 1pt 0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:8pt;text-align:center;margin:0pt;"><b style="font-weight:bold;">Name of Each Exchange on Which</b><b style="font-weight:bold;"><br /></b><b style="font-weight:bold;">Registered</b></p></td></tr><tr><td style="vertical-align:bottom;width:31.99%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><ix:nonNumeric contextRef="Duration_1_24_2022_To_1_24_2022_P3L-cmD3wUmJzWnjpHR7jg" name="dei:Security12bTitle" id="Tc_LJZ-tCB3KESZs9NstTzbqQ_2_0">Common Stock, par value $0.001 per share</ix:nonNumeric></p></td><td style="vertical-align:bottom;width:1.99%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;width:32%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><ix:nonNumeric contextRef="Duration_1_24_2022_To_1_24_2022_P3L-cmD3wUmJzWnjpHR7jg" name="dei:TradingSymbol" id="Tc_TOKxGypnmkmvDWFNUambZQ_2_2">CAPR</ix:nonNumeric></p></td><td style="vertical-align:bottom;width:2%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;width:32%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;">The <ix:nonNumeric contextRef="Duration_1_24_2022_To_1_24_2022_P3L-cmD3wUmJzWnjpHR7jg" format="ixt-sec:exchnameen" name="dei:SecurityExchangeName" id="Narr_CUigrwuwDUik_Ww1YcTV-A">Nasdaq</ix:nonNumeric> Capital Market</p></td></tr></table><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:1pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:5pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;line-height:1pt;padding-bottom:1pt;padding-top:1pt;border-bottom:3.0pt solid #000000;border-top:1.0pt solid #000000;margin:0pt;"><span style="font-size:1pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:3pt;visibility:hidden;">&#8203;</span></p><p style="display:none;line-height:0pt;text-align:center;margin:0pt;"><span style="font-family:'Times New Roman','Times','serif';font-size:0pt;margin-bottom:5pt;margin-top:5pt;visibility:hidden;">&#8203;</span></p></div></div>
<div style="background-color:#000000;clear:both;height:2pt;page-break-after:always;width:82.35%;border:0;margin:30pt 8.82% 30pt 8.82%;"></div><div style="max-width:100%;padding-left:8.82%;padding-right:8.82%;position:relative;"><div style="clear:both;max-width:100%;position:relative;"><table style="border-collapse:collapse;border:0;"><tr><td style="vertical-align:text-top;white-space:nowrap;width:50.25pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin-bottom:0pt;margin-top:0pt;"><b style="font-weight:bold;">Item 1.01</b></p></td><td style="padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin-bottom:0pt;margin-top:0pt;"><b style="font-weight:bold;white-space:pre-wrap;">Entry into a Material Definitive Agreement.  </b></p></td></tr></table><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:14pt 0pt 0pt 0pt;"><i style="font-style:italic;">Commercialization and Distribution Agreement</i></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:14pt 0pt 0pt 0pt;">On January 24, 2022, Capricor Therapeutics, Inc. (the &#8220;Company&#8221; or &#8220;Capricor&#8221;) entered into an Exclusive Commercialization and Distribution Agreement (the &#8220;Agreement&#8221;) with Nippon Shinyaku, Co., Ltd., a Japanese corporation, (&#8220;Nippon Shinyaku&#8221;). Under the terms of the Agreement, Capricor appointed Nippon Shinyaku as its exclusive distributor in the United States, of CAP-1002, the Company&#8217;s lead product candidate, for the treatment of Duchenne muscular dystrophy.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:14pt 0pt 0pt 0pt;">Under the terms of the agreement, Capricor will be responsible for the conduct of HOPE-3 as well as the manufacturing of CAP-1002. Nippon Shinyaku will be responsible for the distribution of CAP-1002 in the United States. Capricor will sell commercial product to Nippon Shinyaku and in addition will receive a meaningful, double-digit share of product revenue and additional development and sales-based milestone payments. Capricor will receive an upfront payment of $30.0 million with potential additional milestone payments of up to $705.0 million. </p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:14pt 0pt 0pt 0pt;">The Company expects to file the Agreement as an exhibit to its Annual Report on Form 10-K for the year ended December 31, 2021 and intends to seek confidential treatment for certain terms and provisions of the Agreement. The foregoing description is a summary of the material terms of the Agreement, does not purport to be complete, and is qualified in its entirety by reference to the text of the Agreement when filed. </p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:14pt 0pt 0pt 0pt;">A copy of the press release is attached hereto as Exhibit 99.1.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="margin-bottom:5pt;margin-top:5pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="display:inline-block;text-indent:0pt;width:50.4pt;"><b style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-style:normal;font-weight:bold;">Item 9.01</b></span><b style="font-weight:bold;">Financial Statements and Exhibits. &#160;</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="margin-bottom:5pt;margin-top:5pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><b style="font-weight:bold;">(d) Exhibits</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="margin-bottom:5pt;margin-top:5pt;visibility:hidden;">&#8203;</span></p><table style="border-collapse:collapse;font-size:16pt;height:max-content;padding-left:0pt;padding-right:0pt;width:100%;"><tr><td style="vertical-align:top;width:5%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">99.1</p></td><td style="vertical-align:bottom;width:2%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;width:92.99%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt;"><a style="-sec-extract:exhibit;font-family:&quot;'Times New Roman','Times','serif'&quot;;" href="capr-20220124xex99d1.htm"><span style="font-family:'Times New Roman','Times','serif';font-style:normal;font-weight:normal;">Press Release, titled &#8220;Capricor Therapeutics and Nippon Shinyaku Enter Partnership for Exclusive Commercialization and Distribution of CAP-1002 for the Treatment of Duchenne Muscular Dystrophy in the U.S.&#8221;, dated January 25, 2022</span></a>.</p></td></tr><tr><td style="vertical-align:top;width:5%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></td><td style="vertical-align:bottom;width:2%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></td><td style="vertical-align:bottom;width:92.99%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></td></tr><tr><td style="vertical-align:top;width:5%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">104</p></td><td style="vertical-align:bottom;width:2%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></td><td style="vertical-align:bottom;width:92.99%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt;">Cover Page Interactive Data File (formatted as Inline XBRL)</p></td></tr></table><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></div><div style="clear:both;display:table;margin-bottom:30pt;min-height:18pt;width:100%;"><div style="display:table-cell;vertical-align:bottom;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:24pt 0pt 0pt 0pt;">2</p></div></div></div>
<div style="background-color:#000000;clear:both;height:2pt;page-break-after:always;width:82.35%;border:0;margin:30pt 8.82% 30pt 8.82%;"></div><div style="max-width:100%;padding-left:8.82%;padding-right:8.82%;position:relative;"><div style="margin-top:30pt;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:right;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></div><div style="clear:both;max-width:100%;position:relative;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><b style="font-weight:bold;">SIGNATURES</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><span style="margin-bottom:5pt;margin-top:5pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">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:0pt;"><span style="margin-bottom:5pt;margin-top:5pt;visibility:hidden;">&#8203;</span></p><table style="border-collapse:collapse;font-size:16pt;height:max-content;padding-left:0pt;padding-right:0pt;width:100%;"><tr style="height:1pt;"><td style="vertical-align:top;width:50%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="position:absolute;top:0pt;width:100%;"></div></div></td><td style="vertical-align:top;width:2.99%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="position:absolute;top:0pt;width:100%;"></div></div></td><td style="vertical-align:top;width:47%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="position:absolute;top:0pt;width:100%;"></div></div></td></tr><tr><td style="vertical-align:top;width:50%;margin:0pt;padding:0pt;"></td><td colspan="2" style="vertical-align:top;width:50%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><b style="font-weight:bold;">CAPRICOR THERAPEUTICS, INC.</b></p></td></tr><tr><td style="vertical-align:top;width:50%;margin:0pt;padding:0pt;"></td><td style="vertical-align:top;width:2.99%;margin:0pt;padding:0pt;"></td><td style="vertical-align:top;width:47%;margin:0pt;padding:0pt;"></td></tr><tr><td style="vertical-align:top;width:50%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">Date:&#160;&#160;January 25, 2022</p></td><td style="vertical-align:top;width:2.99%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">By:</p></td><td style="vertical-align:top;width:47%;border-bottom:1.0pt solid #000000;margin:0pt;padding:0pt 0pt 0pt 9pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">/s/ Linda Marb&#225;n, Ph.D.</p></td></tr><tr><td style="vertical-align:top;width:50%;margin:0pt;padding:0pt;"></td><td style="vertical-align:top;width:2.99%;margin:0pt;padding:0pt;"></td><td style="vertical-align:top;width:47%;margin:0pt;padding:0pt 0pt 0pt 9pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">Linda Marb&#225;n, Ph.D.</p></td></tr><tr><td style="vertical-align:top;width:50%;margin:0pt;padding:0pt;"></td><td style="vertical-align:top;width:2.99%;margin:0pt;padding:0pt;"></td><td style="vertical-align:top;width:47%;margin:0pt;padding:0pt 0pt 0pt 9pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">Chief Executive Officer</p></td></tr></table><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></div><div style="clear:both;display:table;margin-bottom:30pt;min-height:18pt;width:100%;"><div style="display:table-cell;vertical-align:bottom;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:24pt 0pt 0pt 0pt;">3</p></div></div></div>
<div style="background-color:#000000;clear:both;height:2pt;margin-left:8.82%;margin-right:8.82%;margin-top:30pt;page-break-after:avoid;width:82.35%;border:0;"></div></body></html>
[{"type": "8-K", "sequence": "1", "filename": "capr-20220124x8k.htm", "description": "8-K", "secsgml_size_bytes": 39567}]
{"company-data": {"conformed-name": "CAPRICOR THERAPEUTICS, INC.", "cik": "0001133869", "assigned-sic": "2834", "irs-number": "000000000", "state-of-incorporation": "DE", "fiscal-year-end": "1231"}, "filing-values": {"form-type": "8-K", "act": "34", "file-number": "001-34058", "film-number": "22551007"}, "business-address": {"street1": "8840 WILSHIRE BLVD", "street2": "2ND FLOOR", "city": "BEVERLY HILLS", "state": "CA", "zip": "90211", "phone": "(310) 358-3200"}, "mail-address": {"street1": "8840 WILSHIRE BLVD", "street2": "2ND FLOOR", "city": "BEVERLY HILLS", "state": "CA", "zip": "90211"}, "former-company": [{"former-conformed-name": "Nile Therapeutics, Inc.", "date-changed": "20070920"}, {"former-conformed-name": "SMI PRODUCTS INC", "date-changed": "20010206"}]}
​
​
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
​
FORM
8-K
​
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
​
Date of Report (Date of earliest event reported)
​
January 24, 2022
​
CAPRICOR THERAPEUTICS, INC.
(Exact name of Registrant as Specified in its Charter)
​
​
​
Delaware
001-34058
88-0363465
(State or other jurisdiction
of incorporation)
​
(Commission
File Number)
​
(I.R.S. Employer
Identification No.)
​
8840 Wilshire Blvd.
,
2nd Floor
,
Beverly Hills
,
CA
(Address of principal executive offices)
90211
(Zip Code)
​
(
310
)
358-3200
(Registrant's telephone number, including area code)
​
Not Applicable
(Former name or former address, if changed since last report)
​
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:
​
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
​
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
​
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
​
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
​
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
​
Emerging growth company
☐
​
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.
◻
​
Securities registered pursuant to Section 12(b) of the Act:
​
Title of Each Class
Trading Symbol(s)
Name of Each Exchange on Which
Registered
Common Stock, par value $0.001 per share
CAPR
The
Nasdaq
Capital Market
​
​
​
​
Item 1.01
Entry into a Material Definitive Agreement.
Commercialization and Distribution Agreement
On January 24, 2022, Capricor Therapeutics, Inc. (the "Company" or "Capricor") entered into an Exclusive Commercialization and Distribution Agreement (the "Agreement") with Nippon Shinyaku, Co., Ltd., a Japanese corporation, ("Nippon Shinyaku"). Under the terms of the Agreement, Capricor appointed Nippon Shinyaku as its exclusive distributor in the United States, of CAP-1002, the Company's lead product candidate, for the treatment of Duchenne muscular dystrophy.
Under the terms of the agreement, Capricor will be responsible for the conduct of HOPE-3 as well as the manufacturing of CAP-1002. Nippon Shinyaku will be responsible for the distribution of CAP-1002 in the United States. Capricor will sell commercial product to Nippon Shinyaku and in addition will receive a meaningful, double-digit share of product revenue and additional development and sales-based milestone payments. Capricor will receive an upfront payment of $30.0 million with potential additional milestone payments of up to $705.0 million.
The Company expects to file the Agreement as an exhibit to its Annual Report on Form 10-K for the year ended December 31, 2021 and intends to seek confidential treatment for certain terms and provisions of the Agreement. The foregoing description is a summary of the material terms of the Agreement, does not purport to be complete, and is qualified in its entirety by reference to the text of the Agreement when filed.
A copy of the press release is attached hereto as Exhibit 99.1.
​
Item 9.01
Financial Statements and Exhibits.
​
(d) Exhibits
​
99.1
Press Release, titled "Capricor Therapeutics and Nippon Shinyaku Enter Partnership for Exclusive Commercialization and Distribution of CAP-1002 for the Treatment of Duchenne Muscular Dystrophy in the U.S.", dated January 25, 2022
.
​
​
​
104
​
Cover Page Interactive Data File (formatted as Inline XBRL)
​
​
2
​
SIGNATURES
​
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.
​
CAPRICOR THERAPEUTICS, INC.
Date:  January 25, 2022
By:
/s/ Linda Marbán, Ph.D.
Linda Marbán, Ph.D.
Chief Executive Officer
​
​
3