<?xml version='1.0' encoding='ASCII'?>
<!-- DFIN New ActiveDisclosure (SM) Inline XBRL Document - http://www.dfinsolutions.com/ -->
<!-- Creation Date :2024-05-08T06:22:41.0722+00:00 -->
<!-- Copyright (c) 2024 Donnelly Financial Solutions, Inc. All Rights Reserved. -->
<html xmlns="http://www.w3.org/1999/xhtml" xmlns:xbrldi="http://xbrl.org/2006/xbrldi" xmlns:xbrldt="http://xbrl.org/2005/xbrldt" xmlns:xbrli="http://www.xbrl.org/2003/instance" xmlns:link="http://www.xbrl.org/2003/linkbase" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:ix="http://www.xbrl.org/2013/inlineXBRL" xmlns:nonNumeric="http://www.xbrl.org/dtr/type/non-numeric" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns:dei="http://xbrl.sec.gov/dei/2023" xmlns:cytk="http://cytokinetics.com/20240508" xmlns:ixt-sec="http://www.sec.gov/inlineXBRL/transformation/2015-08-31" xmlns:ixt="http://www.xbrl.org/inlineXBRL/transformation/2022-02-16">
 <head>
  <title>8-K</title>
  <meta http-equiv="Content-Type" content="text/html"/>
 </head>
 <body style="margin: auto!important;padding: 8px;">
  <div style="display:none;"><ix:header><ix:hidden><ix:nonNumeric id="F_7377b7e5-b769-453d-a721-ee3667b0189c" name="dei:EntityCentralIndexKey" contextRef="C_ac528e54-b1f6-46be-a7f5-86b50c79500c">0001061983</ix:nonNumeric><ix:nonNumeric id="F_0749de45-ef16-46d6-b29f-0da1937c96b9" name="dei:AmendmentFlag" contextRef="C_ac528e54-b1f6-46be-a7f5-86b50c79500c">false</ix:nonNumeric></ix:hidden><ix:references><link:schemaRef xlink:type="simple" xlink:href="cytk-20240508.xsd"/></ix:references><ix:resources><xbrli:context id="C_ac528e54-b1f6-46be-a7f5-86b50c79500c"><xbrli:entity><xbrli:identifier scheme="http://www.sec.gov/CIK">0001061983</xbrli:identifier></xbrli:entity><xbrli:period><xbrli:startDate>2024-05-08</xbrli:startDate><xbrli:endDate>2024-05-08</xbrli:endDate></xbrli:period></xbrli:context></ix:resources></ix:header></div>
  <div style="min-height:0.5in;"></div>
  <p style="border-top:2.25pt double #000000;font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">&#160;</span></p>
  <p style="font-size:10pt;margin-top:5.75pt;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:18pt;font-family:Times New Roman;min-width:fit-content;">UNITED STATES<br/>SECURITIES AND EXCHANGE COMMISSION<br/></span><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:12pt;font-family:Times New Roman;min-width:fit-content;">WASHINGTON, D.C. 20549</span></p>
  <p style="margin-left:40%;font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;border-bottom:0.75pt solid #000000;margin-right:40%;text-align:left;"><span style="white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">&#160;</span></p>
  <p style="font-size:10pt;margin-top:10pt;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:18pt;font-family:Times New Roman;min-width:fit-content;">FORM </span><span style="font-size:18pt;font-family:Times New Roman;"><ix:nonNumeric id="F_42101e0d-15e3-4d6c-9414-08b38bd80edd" contextRef="C_ac528e54-b1f6-46be-a7f5-86b50c79500c" name="dei:DocumentType"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:18pt;font-family:Times New Roman;min-width:fit-content;">8-K</span></ix:nonNumeric></span></p>
  <p style="margin-left:40%;font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;border-bottom:0.75pt solid #000000;margin-right:40%;text-align:left;"><span style="white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">&#160;</span></p>
  <p style="font-size:10pt;margin-top:9pt;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:12pt;font-family:Times New Roman;min-width:fit-content;">CURRENT REPORT</span></p>
  <p style="font-size:10pt;margin-top:9pt;font-family:Times New Roman;margin-bottom:6pt;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:12pt;font-family:Times New Roman;min-width:fit-content;">Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934</span></p>
  <table style="border-spacing:0;table-layout:fixed;width:100.0%;border-collapse:separate;">
   <tr style="visibility:collapse;">
    <td style="width:100%;"/>
   </tr>
   <tr style="height:10pt;word-break:break-word;white-space:pre-wrap;text-align:left;">
    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;margin-right:0.02986111111111111in;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">Date of Report (Date of earliest event reported): </span><span><ix:nonNumeric id="F_f633f213-7840-4215-9ccf-c9d4a9fe3d95" contextRef="C_ac528e54-b1f6-46be-a7f5-86b50c79500c" name="dei:DocumentPeriodEndDate" format="ixt:date-monthname-day-year-en"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">May 08, 2024</span></ix:nonNumeric></span></p></td>
   </tr>
  </table>
  <p style="margin-left:40%;font-size:10pt;margin-top:5pt;font-family:Times New Roman;margin-bottom:0;border-bottom:0.75pt solid #000000;margin-right:40%;text-align:left;"><span style="white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">&#160;</span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">&#160;</span></p>
  <p style="font-size:10pt;margin-top:5pt;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="font-size:24pt;font-family:Times New Roman;"><ix:nonNumeric id="F_f09b9a0a-5957-40dd-b726-1bfff3c424d5" contextRef="C_ac528e54-b1f6-46be-a7f5-86b50c79500c" name="dei:EntityRegistrantName"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:24pt;font-family:Times New Roman;min-width:fit-content;">Cytokinetics, Incorporated</span></ix:nonNumeric></span></p>
  <p style="font-size:10pt;margin-top:3pt;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:7.5pt;font-family:Times New Roman;min-width:fit-content;">(Exact name of Registrant as Specified in Its Charter)</span></p>
  <p style="margin-left:40%;font-size:10pt;margin-top:9pt;font-family:Times New Roman;margin-bottom:0;border-bottom:0.75pt solid #000000;margin-right:40%;text-align:left;"><span style="white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">&#160;</span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">&#160;</span></p>
  <table style="border-spacing:0;table-layout:fixed;width:100.0%;border-collapse:separate;">
   <tr style="visibility:collapse;">
    <td style="width:20%;"/>
    <td style="width:1%;"/>
    <td style="width:20%;"/>
    <td style="width:18%;"/>
    <td style="width:41%;"/>
   </tr>
   <tr style="height:10pt;word-break:break-word;white-space:pre-wrap;text-align:left;">
    <td colspan="3" style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span><ix:nonNumeric id="F_309eb438-8bc2-4d66-a286-51b60f50867c" contextRef="C_ac528e54-b1f6-46be-a7f5-86b50c79500c" name="dei:EntityIncorporationStateCountryCode" format="ixt-sec:stateprovnameen"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">Delaware</span></ix:nonNumeric></span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span><ix:nonNumeric id="F_0aa0a95b-52b0-4355-a508-d04f565c31d9" contextRef="C_ac528e54-b1f6-46be-a7f5-86b50c79500c" name="dei:EntityFileNumber"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">000-50633</span></ix:nonNumeric></span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span><ix:nonNumeric id="F_801fd5e0-6736-4f03-b4b4-cd2b545c8e0a" contextRef="C_ac528e54-b1f6-46be-a7f5-86b50c79500c" name="dei:EntityTaxIdentificationNumber"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">94-3291317</span></ix:nonNumeric></span></p></td>
   </tr>
   <tr style="height:7pt;word-break:break-word;white-space:pre-wrap;text-align:left;">
    <td colspan="3" style="padding-top:0.01in;vertical-align:top;"><p style="font-size:7.5pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">(State or Other Jurisdiction<br/>of Incorporation)</span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:7.5pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">(Commission File Number)</span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:7.5pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">(IRS Employer<br/>Identification No.)</span></p></td>
   </tr>
   <tr style="word-break:break-word;white-space:pre-wrap;text-align:left;">
    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="white-space:pre-wrap;min-width:fit-content;">&#160;</span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="white-space:pre-wrap;min-width:fit-content;">&#160;</span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="white-space:pre-wrap;min-width:fit-content;">&#160;</span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="white-space:pre-wrap;min-width:fit-content;">&#160;</span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="white-space:pre-wrap;min-width:fit-content;">&#160;</span></p></td>
   </tr>
   <tr style="height:10pt;word-break:break-word;white-space:pre-wrap;text-align:left;">
    <td colspan="3" style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span><ix:nonNumeric id="F_07b08a86-36ed-4898-b07d-ca4d48210688" contextRef="C_ac528e54-b1f6-46be-a7f5-86b50c79500c" name="dei:EntityAddressAddressLine1"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">350 Oyster Point Boulevard</span></ix:nonNumeric></span></p></td>
    <td colspan="2" style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="white-space:pre-wrap;min-width:fit-content;">&#160;</span></p></td>
   </tr>
   <tr style="height:10pt;word-break:break-word;white-space:pre-wrap;">
    <td colspan="3" style="padding-top:0.01in;vertical-align:top;text-align:left;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span><ix:nonNumeric id="F_9449796d-d1b9-4a77-ad2d-12a84af03fe4" contextRef="C_ac528e54-b1f6-46be-a7f5-86b50c79500c" name="dei:EntityAddressCityOrTown"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">South San Francisco</span></ix:nonNumeric></span><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">, </span><span><ix:nonNumeric id="F_7738089d-07c7-4351-a512-7dfbc158b7a9" contextRef="C_ac528e54-b1f6-46be-a7f5-86b50c79500c" name="dei:EntityAddressStateOrProvince" format="ixt-sec:stateprovnameen"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">California</span></ix:nonNumeric></span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;min-width:fit-content;">&#160;</span></p></td>
    <td style="padding-top:0.01in;vertical-align:bottom;text-align:left;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span><ix:nonNumeric id="F_cfe10129-7a7a-4b8f-b58d-e93e835612ee" contextRef="C_ac528e54-b1f6-46be-a7f5-86b50c79500c" name="dei:EntityAddressPostalZipCode"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">94080</span></ix:nonNumeric></span></p></td>
   </tr>
   <tr style="height:7pt;word-break:break-word;white-space:pre-wrap;text-align:left;">
    <td colspan="3" style="padding-top:0.01in;vertical-align:top;"><p style="font-size:7.5pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">(Address of Principal Executive Offices)</span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="white-space:pre-wrap;min-width:fit-content;">&#160;</span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:7.5pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">(Zip Code)</span></p></td>
   </tr>
  </table>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">&#160;</span></p>
  <table style="border-spacing:0;table-layout:fixed;width:100.0%;border-collapse:separate;">
   <tr style="visibility:collapse;">
    <td style="width:100%;"/>
   </tr>
   <tr style="height:10pt;word-break:break-word;white-space:pre-wrap;text-align:left;">
    <td style="padding-top:0.125in;vertical-align:top;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;margin-right:0.02986111111111111in;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">Registrant&#8217;s Telephone Number, Including Area Code:</span><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;"> </span><span><ix:nonNumeric id="F_4d3f410d-9906-4ea4-a95d-b7125aba5799" contextRef="C_ac528e54-b1f6-46be-a7f5-86b50c79500c" name="dei:CityAreaCode"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">(650)</span></ix:nonNumeric></span><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;"> </span><span><ix:nonNumeric id="F_f0cea029-8d0e-4163-b75d-98b10e7342ee" contextRef="C_ac528e54-b1f6-46be-a7f5-86b50c79500c" name="dei:LocalPhoneNumber"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">624-3000</span></ix:nonNumeric></span></p></td>
   </tr>
  </table>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">&#160;</span></p>
  <table style="border-spacing:0;table-layout:fixed;width:100.0%;border-collapse:separate;">
   <tr style="visibility:collapse;">
    <td style="width:100%;"/>
   </tr>
   <tr style="height:10pt;word-break:break-word;white-space:pre-wrap;text-align:left;">
    <td style="padding-top:0.125in;vertical-align:top;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span><ix:nonNumeric id="F_0b610d2d-3a73-4803-bb48-ba0bbfa9858b" contextRef="C_ac528e54-b1f6-46be-a7f5-86b50c79500c" name="dei:EntityInformationFormerLegalOrRegisteredName"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">N/A</span></ix:nonNumeric></span></p></td>
   </tr>
  </table>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:7.5pt;font-family:Times New Roman;min-width:fit-content;">(Former Name or Former Address, if Changed Since Last Report)</span></p>
  <p style="margin-left:40%;font-size:10pt;margin-top:9.35pt;font-family:Times New Roman;margin-bottom:0;border-bottom:0.75pt solid #000000;margin-right:40%;text-align:left;"><span style="white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">&#160;</span></p>
  <p style="font-size:10pt;margin-top:9.35pt;font-family:Times New Roman;margin-bottom:6pt;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">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:</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p>
  <div style="text-indent:-24.5pt;padding-left:24.5pt;margin-top:9pt;margin-bottom:0;text-align:left;"><span style="margin-right:1em;margin-right:1em;"><span style="font-size:10pt;font-family:Times New Roman;"><ix:nonNumeric id="F_341f8168-5fc2-4f33-859d-b99634f62ecc" contextRef="C_ac528e54-b1f6-46be-a7f5-86b50c79500c" name="dei:WrittenCommunications" format="ixt-sec:boolballotbox"><span style="font-size:10pt;font-family:Times New Roman;">&#9744;</span></ix:nonNumeric></span></span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)</span></div>
  <div style="text-indent:-24.5pt;padding-left:24.5pt;margin-top:6pt;margin-bottom:0;text-align:left;"><span style="margin-right:1em;margin-right:1em;"><span style="font-size:10pt;font-family:Times New Roman;"><ix:nonNumeric id="F_98a7b178-7a97-46ab-8186-0f113c648423" contextRef="C_ac528e54-b1f6-46be-a7f5-86b50c79500c" name="dei:SolicitingMaterial" format="ixt-sec:boolballotbox"><span style="font-size:10pt;font-family:Times New Roman;">&#9744;</span></ix:nonNumeric></span></span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)</span></div>
  <div style="text-indent:-24.5pt;padding-left:24.5pt;margin-top:6pt;margin-bottom:0;text-align:left;"><span style="margin-right:1em;margin-right:1em;"><span style="font-size:10pt;font-family:Times New Roman;"><ix:nonNumeric id="F_fdbc07cc-a435-43f2-b1fa-917f09b3349a" contextRef="C_ac528e54-b1f6-46be-a7f5-86b50c79500c" name="dei:PreCommencementTenderOffer" format="ixt-sec:boolballotbox"><span style="font-size:10pt;font-family:Times New Roman;">&#9744;</span></ix:nonNumeric></span></span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))</span></div>
  <div style="text-indent:-24.5pt;padding-left:24.5pt;margin-top:6pt;margin-bottom:0;text-align:left;"><span style="margin-right:1em;margin-right:1em;"><span style="font-size:10pt;font-family:Times New Roman;"><ix:nonNumeric id="F_b7b13be4-f2a8-41bd-8fed-b80f900ab36d" contextRef="C_ac528e54-b1f6-46be-a7f5-86b50c79500c" name="dei:PreCommencementIssuerTenderOffer" format="ixt-sec:boolballotbox"><span style="font-size:10pt;font-family:Times New Roman;">&#9744;</span></ix:nonNumeric></span></span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))</span></div>
  <p style="font-size:10pt;margin-top:9pt;font-family:Times New Roman;margin-bottom:9pt;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Securities registered pursuant to Section 12(b) of the Act:</span></p>
  <table style="border-spacing:0;table-layout:fixed;width:100.0%;border-collapse:separate;">
   <tr style="visibility:collapse;">
    <td style="width:38%;"/>
    <td style="width:1%;"/>
    <td style="width:15%;"/>
    <td style="width:1%;"/>
    <td style="width:45%;"/>
   </tr>
   <tr style="height:10pt;word-break:break-word;white-space:pre-wrap;">
    <td style="padding-top:0.01in;vertical-align:top;border-bottom:0.25pt solid;text-align:left;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;"><br/>Title of each class</span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;border-bottom:0.25pt solid #ffffff03;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;min-width:fit-content;">&#160;</span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;border-bottom:0.25pt solid;text-align:left;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;">Trading<br/>Symbol(s)</span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;border-bottom:0.25pt solid #ffffff03;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;min-width:fit-content;">&#160;</span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;border-bottom:0.25pt solid;text-align:left;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;min-width:fit-content;"><br/>Name of each exchange on which registered</span></p></td>
   </tr>
   <tr style="height:10pt;word-break:break-word;white-space:pre-wrap;">
    <td style="padding-top:0.01in;vertical-align:top;text-align:left;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span><ix:nonNumeric id="F_88248c3c-08fa-4d3e-a969-47c0bd4592d9" contextRef="C_ac528e54-b1f6-46be-a7f5-86b50c79500c" name="dei:Security12bTitle"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;">Common Stock, $0.001 par value</span></ix:nonNumeric></span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;min-width:fit-content;">&#160;</span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;text-align:left;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span><ix:nonNumeric id="F_217d44de-0c0d-4a45-9361-cb30d0d4350d" contextRef="C_ac528e54-b1f6-46be-a7f5-86b50c79500c" name="dei:TradingSymbol"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;">CYTK</span></ix:nonNumeric></span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;min-width:fit-content;">&#160;</span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;text-align:left;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:center;"><span><ix:nonNumeric id="F_322d7d69-f422-4708-9ca9-2fd41ad94dfc" contextRef="C_ac528e54-b1f6-46be-a7f5-86b50c79500c" name="dei:SecurityExchangeName" format="ixt-sec:exchnameen"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;">The Nasdaq Global Select Market</span></ix:nonNumeric></span></p></td>
   </tr>
  </table>
  <p style="font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (&#167;&#8239;230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (&#167;&#8239;240.12b-2 of this chapter).</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p>
  <p style="font-size:10pt;margin-top:9pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Emerging growth company </span><span style="font-size:10pt;"><ix:nonNumeric id="F_0e97287d-79eb-47bd-8115-e395a3d07af2" contextRef="C_ac528e54-b1f6-46be-a7f5-86b50c79500c" name="dei:EntityEmergingGrowthCompany" format="ixt-sec:boolballotbox"><span style="font-size:10pt;font-family:Times New Roman;">&#9744;</span></ix:nonNumeric></span></p>
  <p style="font-size:10pt;margin-top:9pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">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><span style="font-size:10pt;font-family:Times New Roman;">&#9744;</span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;border-bottom:2.25pt double #000000;text-align:left;"><span style="white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">&#160;</span></p>
  <div style="flex-direction:column;display:flex;min-height:0.5in;justify-content:flex-end;"></div>
  <hr style="page-break-after:always;"/>
  <div style="min-height:0.5in;"></div>
  <p style="font-size:10pt;margin-top:18pt;font-family:Times New Roman;margin-bottom:6pt;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Item 8.01 Other Events.</span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-size:12pt;font-family:Times New Roman;min-width:fit-content;">On May 8, 2024, Cytokinetics, Incorporated (the "Company") announced topline data from the Phase 1 study of CK-4021586 (CK-586). The study met its primary and secondary objectives to assess the safety, tolerability and pharmacokinetics (PK) of single and multiple oral doses of CK-586. The data support the advancement of CK-586 to a Phase 2 clinical trial in patients with heart failure with preserved ejection fraction (HFpEF) which is expected to begin in Q4 2024. CK-586 is a cardiac myosin inhibitor in development for the potential treatment of a subgroup of patients with HFpEF.</span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:justify;"><span style="white-space:pre-wrap;font-size:12pt;font-family:Times New Roman;min-width:fit-content;">&#160;</span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Phase 1 Design and Key Findings</span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:12pt;font-family:Times New Roman;min-width:fit-content;"> </span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-size:12pt;font-family:Times New Roman;min-width:fit-content;">The primary objective of this Phase 1 double-blind randomized, placebo-controlled, multi-part single and multiple ascending dose clinical study was to evaluate the safety, tolerability and PK of CK-586 when administered orally as single or multiple doses to healthy participants. The study design included seven single ascending dose cohorts (10 mg to 600 mg) comprised of 10 participants each, and two multiple-dose ascending cohorts (100 and 200 mg once daily) comprised of 10 participants each. The study met the primary objective, demonstrating that CK-586 was safe and well tolerated in healthy participants with linear PK. Pharmacodynamics were evaluated using echocardiography and consistent with expectations. No serious adverse events were observed, and the stopping criteria were not met in the study.</span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:justify;"><span style="white-space:pre-wrap;font-size:12pt;font-family:Times New Roman;min-width:fit-content;">&#160;</span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">About CK-4021586 (CK-586)</span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:12pt;font-family:Times New Roman;min-width:fit-content;"> </span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-size:12pt;font-family:Times New Roman;min-width:fit-content;">CK-4021586 (CK-586) is a novel, selective, oral, small molecule cardiac myosin inhibitor designed to reduce the hypercontractility associated with heart failure with preserved ejection fraction (HFpEF). In preclinical models, CK-586 reduced cardiac hypercontractility by decreasing the number of active myosin cross-bridges during cardiac contraction thereby reducing the contractile force, without effect on calcium transients. In some patients, HFpEF is a condition that resembles non-obstructive hypertrophic cardiomyopathy (HCM) in that the patients have higher ejection fractions, thickened walls of their heart, elevated biomarkers, and symptoms of heart failure. In a Phase 2 clinical trial in patients with non-obstructive HCM, </span><span style="color:#000000;white-space:pre-wrap;font-size:12pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">aficamten</span><span style="color:#000000;white-space:pre-wrap;font-size:12pt;font-family:Times New Roman;min-width:fit-content;">, a cardiac myosin inhibitor also developed by the Company, was well tolerated, improved patient reported outcomes (Kansas City Cardiomyopathy Questionnaire (KCCQ) and New York Heart Association (NYHA) Functional Class) and biomarkers, measures that are also relevant to HFpEF, lending support for this mechanism of action in HFpEF.</span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:justify;"><span style="white-space:pre-wrap;font-size:12pt;font-family:Times New Roman;min-width:fit-content;">&#160;</span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Forward-Looking Statements</span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:12pt;font-family:Times New Roman;min-width:fit-content;"> </span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-size:12pt;font-family:Times New Roman;min-width:fit-content;">This filing contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act's Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements, express or implied, relating to the potential benefits of CK-586 for patients with heart failure with preserved ejection fraction (HFpEF) and our ability to commence a Phase 2 clinical trial of CK-586 in the fourth quarter of 2024, if ever. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing, or production of Cytokinetics' drug candidates that could slow or prevent clinical development or product approval; Cytokinetics' drug candidates may have adverse side effects or inadequate therapeutic efficacy; the FDA or foreign regulatory agencies may delay or limit Cytokinetics' ability to conduct clinical trials; Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; standards of care may change, rendering Cytokinetics' drug candidates obsolete; and competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics' drug candidates and potential drug candidates may target. For further information regarding these and other risks related to Cytokinetics' business, investors should consult Cytokinetics' filings with the Securities and Exchange Commission.</span></p>
  <div style="flex-direction:column;display:flex;min-height:0.5in;justify-content:flex-end;"></div>
  <hr style="page-break-after:always;"/>
  <div style="min-height:0.5in;"></div>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:9.35pt;text-align:center;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">SIGNATURES</span></p>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:9.35pt;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">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.</span></p>
  <table style="border-spacing:0;table-layout:fixed;width:100.0%;border-collapse:separate;">
   <tr style="visibility:collapse;">
    <td style="width:6%;"/>
    <td style="width:44%;"/>
    <td style="width:4%;"/>
    <td style="width:46%;"/>
   </tr>
   <tr style="height:10pt;word-break:break-word;white-space:pre-wrap;">
    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;min-width:fit-content;">&#160;</span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;min-width:fit-content;">&#160;</span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;min-width:fit-content;">&#160;</span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:4.3pt;font-family:Times New Roman;margin-bottom:4.3pt;text-align:left;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;">CYTOKINETICS, INCORPORATED</span></p></td>
   </tr>
   <tr style="word-break:break-word;white-space:pre-wrap;">
    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;min-width:fit-content;">&#160;</span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;min-width:fit-content;">&#160;</span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;min-width:fit-content;">&#160;</span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;min-width:fit-content;">&#160;</span></p></td>
   </tr>
   <tr style="height:10pt;word-break:break-word;white-space:pre-wrap;">
    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:4.3pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;">Date:</span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:4.3pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;">May 08, 2024</span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:4.3pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;">By:</span><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;"> </span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;border-bottom:0.25pt solid;"><p style="font-size:10pt;margin-top:4.3pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;">/s/ John O. Faurescu</span></p></td>
   </tr>
   <tr style="height:10pt;word-break:break-word;white-space:pre-wrap;">
    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;min-width:fit-content;">&#160;</span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;min-width:fit-content;">&#160;</span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;min-width:fit-content;">&#160;</span></p></td>
    <td style="padding-top:0.01in;vertical-align:top;"><p style="font-size:10pt;margin-top:0.7pt;font-family:Times New Roman;margin-bottom:9.35pt;text-align:left;"><span style="color:#000000;white-space:pre-wrap;min-width:fit-content;">John O. Faurescu, Associate General Counsel &amp; Secretary</span></p></td>
   </tr>
  </table>
  <p style="font-size:10pt;margin-top:0;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">&#160;</span></p>
  <div style="flex-direction:column;display:flex;min-height:0.5in;justify-content:flex-end;"></div>
  <hr style="page-break-after:always;"/>
 </body>
</html>
[{"type": "8-K", "sequence": "1", "filename": "cytk-20240508.htm", "description": "8-K", "secsgml_size_bytes": 41474}]
{"company-data": {"conformed-name": "CYTOKINETICS INC", "cik": "0001061983", "assigned-sic": "2834", "organization-name": "03 Life Sciences", "irs-number": "943291317", "fiscal-year-end": "1231"}, "filing-values": {"form-type": "8-K", "act": "34", "file-number": "000-50633", "film-number": "24924161"}, "business-address": {"street1": "350 OYSTER POINT BOULEVARD", "street2": ".", "city": "SOUTH SAN FRANCISCO", "state": "CA", "zip": "94080", "phone": "(650) 624-3000"}, "mail-address": {"street1": "350 OYSTER POINT BOULEVARD", "city": "SOUTH SAN FRANCISCO", "state": "CA", "zip": "94080"}}
8-K
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):
May 08, 2024
Cytokinetics, Incorporated
(Exact name of Registrant as Specified in Its Charter)
Delaware
000-50633
94-3291317
(State or Other Jurisdiction
of Incorporation)
(Commission File Number)
(IRS Employer
Identification No.)
350 Oyster Point Boulevard
South San Francisco
,
California
94080
(Address of Principal Executive Offices)
(Zip Code)
Registrant's Telephone Number, Including Area Code:
(650)
624-3000
N/A
(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))
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, $0.001 par value
CYTK
The Nasdaq Global Select Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
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.
☐
Item 8.01 Other Events.
On May 8, 2024, Cytokinetics, Incorporated (the "Company") announced topline data from the Phase 1 study of CK-4021586 (CK-586). The study met its primary and secondary objectives to assess the safety, tolerability and pharmacokinetics (PK) of single and multiple oral doses of CK-586. The data support the advancement of CK-586 to a Phase 2 clinical trial in patients with heart failure with preserved ejection fraction (HFpEF) which is expected to begin in Q4 2024. CK-586 is a cardiac myosin inhibitor in development for the potential treatment of a subgroup of patients with HFpEF.
Phase 1 Design and Key Findings
The primary objective of this Phase 1 double-blind randomized, placebo-controlled, multi-part single and multiple ascending dose clinical study was to evaluate the safety, tolerability and PK of CK-586 when administered orally as single or multiple doses to healthy participants. The study design included seven single ascending dose cohorts (10 mg to 600 mg) comprised of 10 participants each, and two multiple-dose ascending cohorts (100 and 200 mg once daily) comprised of 10 participants each. The study met the primary objective, demonstrating that CK-586 was safe and well tolerated in healthy participants with linear PK. Pharmacodynamics were evaluated using echocardiography and consistent with expectations. No serious adverse events were observed, and the stopping criteria were not met in the study.
About CK-4021586 (CK-586)
CK-4021586 (CK-586) is a novel, selective, oral, small molecule cardiac myosin inhibitor designed to reduce the hypercontractility associated with heart failure with preserved ejection fraction (HFpEF). In preclinical models, CK-586 reduced cardiac hypercontractility by decreasing the number of active myosin cross-bridges during cardiac contraction thereby reducing the contractile force, without effect on calcium transients. In some patients, HFpEF is a condition that resembles non-obstructive hypertrophic cardiomyopathy (HCM) in that the patients have higher ejection fractions, thickened walls of their heart, elevated biomarkers, and symptoms of heart failure. In a Phase 2 clinical trial in patients with non-obstructive HCM,
aficamten
, a cardiac myosin inhibitor also developed by the Company, was well tolerated, improved patient reported outcomes (Kansas City Cardiomyopathy Questionnaire (KCCQ) and New York Heart Association (NYHA) Functional Class) and biomarkers, measures that are also relevant to HFpEF, lending support for this mechanism of action in HFpEF.
Forward-Looking Statements
This filing contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act's Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements, express or implied, relating to the potential benefits of CK-586 for patients with heart failure with preserved ejection fraction (HFpEF) and our ability to commence a Phase 2 clinical trial of CK-586 in the fourth quarter of 2024, if ever. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing, or production of Cytokinetics' drug candidates that could slow or prevent clinical development or product approval; Cytokinetics' drug candidates may have adverse side effects or inadequate therapeutic efficacy; the FDA or foreign regulatory agencies may delay or limit Cytokinetics' ability to conduct clinical trials; Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; standards of care may change, rendering Cytokinetics' drug candidates obsolete; and competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics' drug candidates and potential drug candidates may target. For further information regarding these and other risks related to Cytokinetics' business, investors should consult Cytokinetics' filings with the Securities and Exchange Commission.
SIGNATURES
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.
CYTOKINETICS, INCORPORATED
Date:
May 08, 2024
By:
/s/ John O. Faurescu
John O. Faurescu, Associate General Counsel & Secretary