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contextRef="Duration_12_17_2021_To_12_17_2021_UsM8k82-dUKAvH1w8QEIZg" name="dei:AmendmentFlag" id="Tc_o-1ixljXsUaZG1avjGcfZw_3_1">false</ix:nonNumeric></ix:hidden><ix:references><link:schemaRef xlink:href="pasg-20211217.xsd" xlink:type="simple"></link:schemaRef></ix:references><ix:resources><xbrli:context id="Duration_12_17_2021_To_12_17_2021_UsM8k82-dUKAvH1w8QEIZg"><xbrli:entity><xbrli:identifier scheme="http://www.sec.gov/CIK">0001787297</xbrli:identifier></xbrli:entity><xbrli:period><xbrli:startDate>2021-12-17</xbrli:startDate><xbrli:endDate>2021-12-17</xbrli:endDate></xbrli:period></xbrli:context></ix:resources></ix:header></div><div style="max-width:100%;padding-left:5.88%;padding-right:5.88%;position:relative;"><div style="clear:both;max-width:100%;position:relative;min-height:11.5pt;"><div style="padding-top:1.0px;border-top:3.0pt solid #000000;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;padding-top:1pt;text-align:center;border-top:1.0pt solid #000000;margin:0pt;"><span style="font-size:5pt;font-weight:bold;visibility:hidden;">&#8203;</span></p><a id="_e4a40f0c_69e0_418b_a95d_122ca0531fde"></a></div><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><b style="font-size:17pt;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:17pt;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 0pt 5pt 0pt;"><b style="font-size:12pt;font-weight:bold;">Washington, D.C. 20549</b></p><div style="font-family:'Times New Roman','Times','serif';font-size:10.0pt;margin-bottom:5pt;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:17pt;text-align:center;margin:0pt 0pt 5pt 0pt;"><b style="font-weight:bold;text-transform:uppercase;">FORM </b><ix:nonNumeric contextRef="Duration_12_17_2021_To_12_17_2021_UsM8k82-dUKAvH1w8QEIZg" name="dei:DocumentType" id="Narr_55Mf9AcxlE-yYSdz034JXQ"><b style="font-weight:bold;text-transform:uppercase;">8-K</b></ix:nonNumeric></p><div style="font-family:'Times New Roman','Times','serif';font-size:10.0pt;margin-bottom:5pt;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;"><b style="font-size:12pt;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-size:12pt;font-weight:bold;">Pursuant to Section 13 or 15(d)</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt 0pt 5pt 0pt;"><b style="font-size:12pt;font-weight:bold;">of the Securities Exchange Act of 1934</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:12pt;text-align:center;margin:0pt 0pt 5pt 0pt;"><b style="font-weight:bold;">Date of Report (Date of earliest event reported): </b><ix:nonNumeric contextRef="Duration_12_17_2021_To_12_17_2021_UsM8k82-dUKAvH1w8QEIZg" format="ixt:datemonthdayyearen" name="dei:DocumentPeriodEndDate" id="Narr_MBVRCXL_M06tSHLep5pbYA"><b style="font-weight:bold;">December 17, 2021</b></ix:nonNumeric></p><div style="font-family:'Times New Roman','Times','serif';font-size:10.0pt;margin-bottom:5pt;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 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style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><ix:nonNumeric contextRef="Duration_12_17_2021_To_12_17_2021_UsM8k82-dUKAvH1w8QEIZg" name="dei:EntityAddressAddressLine1" id="Narr_pEhorfbSbUilwLS98iqiPg"><b style="font-weight:bold;">One Commerce Square</b></ix:nonNumeric><b style="font-weight:bold;"><br /></b><ix:nonNumeric contextRef="Duration_12_17_2021_To_12_17_2021_UsM8k82-dUKAvH1w8QEIZg" name="dei:EntityAddressAddressLine2" id="Narr_SVuK8KCIsEmgiDgCMmjx8w"><b style="font-weight:bold;">2005 Market Street, 39</b><sup style="font-size:7.5pt;font-weight:bold;line-height:100%;top:0pt;vertical-align:top;">th</sup><b style="font-weight:bold;"> Floor</b></ix:nonNumeric> <br /><ix:nonNumeric contextRef="Duration_12_17_2021_To_12_17_2021_UsM8k82-dUKAvH1w8QEIZg" name="dei:EntityAddressCityOrTown" id="Narr_qqSgA637j0CPchOMpyQ4Yg"><b style="font-weight:bold;">Philadelphia</b></ix:nonNumeric><b style="font-weight:bold;">, </b><ix:nonNumeric 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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;"><b style="font-weight:bold;">N/A</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt 0pt 5pt 0pt;"><b style="font-weight:bold;">(Former name or former address, if changed since last report)</b></p><div style="font-family:'Times New Roman','Times','serif';font-size:10.0pt;margin-bottom:5pt;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;margin:0pt 0pt 5pt 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><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:5pt;margin-top:0pt;"><ix:nonNumeric contextRef="Duration_12_17_2021_To_12_17_2021_UsM8k82-dUKAvH1w8QEIZg" format="ixt-sec:boolballotbox" name="dei:WrittenCommunications" id="Narr_PuXJqSazHkOGt35dq_VHvA"><span style="font-family:'Segoe UI Symbol';">&#9744;</span></ix:nonNumeric></p></td><td style="padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin-bottom:5pt;margin-top:0pt;">Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)</p></td></tr></table><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:5pt;margin-top:0pt;"><ix:nonNumeric 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style="padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin-bottom:5pt;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><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_12_17_2021_To_12_17_2021_UsM8k82-dUKAvH1w8QEIZg" format="ixt-sec:boolballotbox" name="dei:PreCommencementIssuerTenderOffer" id="Narr_nfbWe8q-d0qreC-nV0Olyg"><span style="font-family:'Segoe UI Symbol';">&#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 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style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="position:absolute;top:0pt;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:top;width:19.99%;margin:0pt;padding:0pt 0.5pt 0pt 0.5pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="position:absolute;top:0pt;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:top;width:39.99%;margin:0pt;padding:0pt 0.5pt 0pt 0.5pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="position:absolute;top:0pt;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></tr><tr><td style="vertical-align:top;width:40%;border-bottom:1px solid #000000;border-left:1px solid #000000;border-right:1px solid #000000;border-top:1px solid #000000;margin:0pt;padding:0pt 0.25pt 0pt 0.25pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:2pt 0pt 2pt 0pt;"><b style="font-weight:bold;">Title of each class</b></p></td><td style="vertical-align:top;width:19.99%;border-bottom:1px solid #000000;border-left:1px solid #000000;border-right:1px solid #000000;border-top:1px solid #000000;margin:0pt;padding:0pt 0.25pt 0pt 0.25pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:2pt 0pt 2pt 0pt;"><b style="font-weight:bold;">Trading symbol(s)</b></p></td><td style="vertical-align:top;width:39.99%;border-bottom:1px solid #000000;border-left:1px solid #000000;border-right:1px solid #000000;border-top:1px solid #000000;margin:0pt;padding:0pt 0.25pt 0pt 0.25pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:2pt 0pt 2pt 0pt;"><b style="font-weight:bold;">Name of each exchange on which registered</b></p></td></tr><tr><td style="vertical-align:top;width:40%;border-bottom:1px solid #000000;border-left:1px solid #000000;border-right:1px solid #000000;border-top:1px solid #000000;margin:0pt;padding:0pt 0.25pt 0pt 0.25pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:2pt 0pt 2pt 0pt;"><ix:nonNumeric contextRef="Duration_12_17_2021_To_12_17_2021_UsM8k82-dUKAvH1w8QEIZg" name="dei:Security12bTitle" id="Tc_mzpE5bChik6I6EB1EIQ9jg_2_0">Common Stock, $0.0001 Par Value Per Share</ix:nonNumeric></p></td><td style="vertical-align:top;width:19.99%;border-bottom:1px solid #000000;border-left:1px solid #000000;border-right:1px solid #000000;border-top:1px solid #000000;margin:0pt;padding:0pt 0.25pt 0pt 0.25pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:2pt 0pt 2pt 0pt;"><ix:nonNumeric contextRef="Duration_12_17_2021_To_12_17_2021_UsM8k82-dUKAvH1w8QEIZg" name="dei:TradingSymbol" id="Tc_LJvuYzeE602aOsNBIVMNAw_2_1">PASG</ix:nonNumeric></p></td><td style="vertical-align:top;width:39.99%;border-bottom:1px solid #000000;border-left:1px solid #000000;border-right:1px solid #000000;border-top:1px solid #000000;margin:0pt;padding:0pt 0.25pt 0pt 0.25pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:2pt 0pt 2pt 0pt;"><ix:nonNumeric contextRef="Duration_12_17_2021_To_12_17_2021_UsM8k82-dUKAvH1w8QEIZg" format="ixt-sec:exchnameen" name="dei:SecurityExchangeName" id="Narr_jmjLfqDrGEetTUb5E6H8FA">The Nasdaq Stock Market LLC</ix:nonNumeric><br />(Nasdaq Global Select Market)</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 0pt 5pt 0pt;"><span style="color:#211d1e;">Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (&#167;230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (&#167;240.12b-2 of this chapter).</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:right;margin:0pt 0pt 5pt 0pt;"><span style="color:#211d1e;">Emerging growth company </span><ix:nonNumeric contextRef="Duration_12_17_2021_To_12_17_2021_UsM8k82-dUKAvH1w8QEIZg" format="ixt-sec:boolballotbox" name="dei:EntityEmergingGrowthCompany" id="Narr_Ha237-UcI0CA2HiVmmoGbQ"><span style="font-family:'Segoe UI Symbol';">&#9746;</span></ix:nonNumeric></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="color:#211d1e;">If an emerging 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Roman','Times','serif';line-height:0pt;margin:0pt;"><span style="font-size:0pt;visibility:hidden;">&#8203;</span></p></div></div>
<div style="background-color:#000000;clear:both;height:2pt;page-break-after:always;width:88.24%;border:0;margin:30pt 5.88% 30pt 5.88%;"></div><div style="max-width:100%;padding-left:10.35%;padding-right:10.35%;position:relative;"><div style="clear:both;max-width:100%;position:relative;"><a id="_ca212a1d_a0f8_4118_a5c9_546d35ae4700"></a><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt;"><b style="font-weight:bold;">Item 7.01 Regulation FD Disclosure.</b></p><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><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt;">On December 17, 2021, Passage Bio, Inc. (the &#8220;<span style="font-style:italic;font-weight:bold;">Company</span>&#8221;), issued a press release announcing positive interim safety and 30-day biomarker data for cohort 1 of its global Phase 1/2 clinical trial for PBGM01 (&#8220;<span style="font-style:italic;font-weight:bold;">Imagine-1</span><span style="white-space:pre-wrap;">&#8221;) for the treatment of early and late  infantile GM1 Gangliosidosis (&#8220;</span><span style="font-style:italic;font-weight:bold;">GM1</span>&#8221;). A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K, which is incorporated herein by reference.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt;">On December 17, 2021, the Company will also give a presentation describing its positive interim safety and 30-day biomarker data for cohort 1 of Imagine-1. A copy of this presentation is attached as Exhibit&#160;99.2 to this Current Report on Form 8-K, which is incorporated herein by reference.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;text-indent:18pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt;">The information in this Item 7.01, including Exhibits 99.1 and 99.2 to this report, shall not be deemed to be &#8220;filed&#8221; for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act. The information contained in this Item 7.01 and in the accompanying Exhibits 99.1 and 99.2 shall not be incorporated by reference into any other filing under the Exchange Act or under the Securities Act, except as shall be expressly set forth by specific reference in such filing.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;text-indent:18pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt;"><b style="font-weight:bold;">Item 8.01&#160;Other Events.</b></p><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;"><i style="font-style:italic;">PBGM01 Program Updates</i></p><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:justify;text-indent:18pt;margin:0pt;">The Company announced the following updates with respect to Imagine-1 for the treatment of early and late infantile GM1:</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p><table style="border-collapse:collapse;border:0;"><tr><td style="width:36pt;padding:0pt;"></td><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;"><span style="font-family:'Symbol';">&#183;</span></p></td><td style="padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin-bottom:0pt;margin-top:0pt;">The Independent Data Monitoring Committee (the <span style="font-family:'Symbol';">&#8220;</span><span style="font-style:italic;font-weight:bold;">IDMC</span>&#8221;) recommended proceeding with two additional planned cohorts in the Imagine-1 clinical study.</p></td></tr></table><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 0pt 54pt;"><span style="margin-left:0pt;visibility:hidden;">&#8203;</span></p><table style="border-collapse:collapse;border:0;"><tr><td style="width:36pt;padding:0pt;"></td><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;"><span style="font-family:'Symbol';">&#183;</span></p></td><td style="padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin-bottom:0pt;margin-top:0pt;">Based on the IDMC recommendation, the Company has initiated recruitment in parallel for both a high-dose cohort of patients with late infantile GM1 (cohort 2) and a low-dose cohort of patients with early infantile GM1 (cohort 3).</p></td></tr></table><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 0pt 54pt;"><span style="margin-left:0pt;visibility:hidden;">&#8203;</span></p><table style="border-collapse:collapse;border:0;"><tr><td style="width:36pt;padding:0pt;"></td><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;"><span style="font-family:'Symbol';">&#183;</span></p></td><td style="padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin-bottom:0pt;margin-top:0pt;">Topline interim results from the Imagine-1 cohort 1, consisting of two patients (patient 1 data through eight months and patient 2 data through two months), showed:</p></td></tr></table><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 0pt 54pt;"><span style="margin-left:0pt;visibility:hidden;">&#8203;</span></p><table style="border-collapse:collapse;border:0;"><tr><td style="width:72pt;padding:0pt;"></td><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;">o</p></td><td style="padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin-bottom:0pt;margin-top:0pt;">With respect to safety, no serious adverse events were reported, and the reported adverse events were all mild to moderate. All moderate adverse events resolved without intervention and were deemed not to be treatment related. No complications related to intra cisterna magna injection were observed, and there was no evidence of dorsal root ganglion toxicity in nerve conduction studies.</p></td></tr></table><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 0pt 72pt;"><span style="margin-left:0pt;visibility:hidden;">&#8203;</span></p><table style="border-collapse:collapse;border:0;"><tr><td style="width:72pt;padding:0pt;"></td><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;">o</p></td><td style="padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin-bottom:0pt;margin-top:0pt;">With respect to beta-galactosidase enzyme activity levels, following PBGM01 administration, beta-galactosidase activity in cerebrospinal fluid (&#8220;<span style="font-style:italic;font-weight:bold;">CSF</span>&#8221;) and serum increased in both patients.</p></td></tr></table><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 0pt 36pt;"><span style="margin-left:0pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 0pt 90pt;">In CSF, for patient 1, enzyme activity at 30 days was 1.5-fold over baseline and the increase was maintained at six months. For patient 2, enzyme activity at 30 days was 4.8-fold over baseline.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 0pt 90pt;"><span style="margin-left:0pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 0pt 90pt;">In serum, for patient 1, enzyme activity was slightly above baseline at 30 days, 1.7-fold over baseline at three months and the increase was maintained at six months. For patient 2, enzyme activity at 30 days was 1.2-fold over baseline.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 0pt 144pt;"><span style="margin-left:0pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 0pt 144pt;"><span style="margin-left:0pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 0pt 144pt;"><span style="margin-left:0pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 0pt 144pt;"><span style="margin-left:0pt;visibility:hidden;">&#8203;</span></p></div><div style="clear:both;margin-bottom:30pt;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 style="background-color:#000000;clear:both;height:2pt;page-break-after:always;width:79.3%;border:0;margin:30pt 10.35% 30pt 10.35%;"></div><div style="max-width:100%;padding-left:10.35%;padding-right:10.35%;position:relative;"><div style="clear:both;max-width:100%;position:relative;"><table style="border-collapse:collapse;border:0;"><tr><td style="width:72pt;padding:0pt;"></td><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;">o</p></td><td style="padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin-bottom:0pt;margin-top:0pt;">With respect to GM1 gangliosides in CSF, large differences were observed at baseline, with patient 2 showing baseline values four times higher than patient 1. For patient 1, levels increased approximately 85 percent at 30 days and remained stable at that level at six months. For patient 2, levels decreased approximately 46 percent at 30 days consistent with high increases in CSF enzyme activity.</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;"><i style="font-style:italic;">Other Updates</i></p><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-indent:18pt;margin:0pt;"><span style="white-space:pre-wrap;">On December 8, 2021, the Company announced that it had exercised two additional options under the research, collaboration and licensing agreement with the Trustees of the University of Pennsylvania for programs in Huntington&#8217;s disease and Canavan disease.  The Company also announced that it expects to dose the first patients in global Phase 1/2 trials for frontotemporal dementia with granulin mutations and Krabbe disease in early 2022, and to provide updated guidance on the timing of data readouts for these two studies after the first patients have been dosed.</span></p><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="display:inline-block;text-indent:0pt;width:48.55pt;"><b style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-style:normal;font-weight:bold;">Item&#160;9.01</b></span><b style="font-weight:bold;">Financial Statements and Exhibits.</b></p><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;">(d)&#160;Exhibits</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p><table style="border-collapse:collapse;font-size:16pt;height:max-content;margin-left:auto;margin-right:auto;padding-left:0pt;padding-right:0pt;width:100%;"><tr><td style="vertical-align:bottom;white-space:nowrap;width:10.52%;border-bottom:1px solid #000000;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:8pt;margin:0pt;"><b style="font-weight:bold;">Exhibit&#160;No.</b></p></td><td style="vertical-align:bottom;width:2.01%;border-bottom:1px solid transparent;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:8pt;margin:0pt;">&#160;&#160;&#160;&#160;</p></td><td style="vertical-align:bottom;width:87.45%;border-bottom:1px solid #000000;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:8pt;text-align:center;margin:0pt 0pt 1pt 0pt;"><b style="font-weight:bold;">Description</b></p></td></tr><tr style="height:6pt;"><td style="vertical-align:middle;width:10.52%;border-top:1px solid #000000;margin:0pt;padding:0pt;"></td><td colspan="2" style="vertical-align:middle;width:89.46%;margin:0pt;padding:0pt;"></td></tr><tr><td style="vertical-align:top;white-space:nowrap;width:10.52%;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:2.01%;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:top;width:87.45%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><a style="-sec-extract:exhibit;font-family:&quot;'Times New Roman','Times','serif'&quot;;" href="pasg-20211217xex99d1.htm"><span style="font-family:'Times New Roman','Times','serif';font-style:normal;font-weight:normal;">Passage Bio, Inc. press release dated December 17, 2021.</span></a></p></td></tr><tr><td style="vertical-align:top;white-space:nowrap;width:10.52%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">99.2</p></td><td style="vertical-align:bottom;width:2.01%;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:top;width:87.45%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><a style="-sec-extract:exhibit;font-family:&quot;'Times New Roman','Times','serif'&quot;;" href="pasg-20211217xex99d2.htm"><span style="font-family:'Times New Roman','Times','serif';font-style:normal;font-weight:normal;">Corporate Presentation.</span></a></p></td></tr><tr><td style="vertical-align:top;white-space:nowrap;width:10.52%;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:2.01%;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:top;width:87.45%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;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;text-align:justify;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="visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 8pt 0pt;"><span style="visibility:hidden;">&#8203;</span></p></div><div style="clear:both;margin-bottom:30pt;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 style="background-color:#000000;clear:both;height:2pt;page-break-after:always;width:79.3%;border:0;margin:30pt 10.35% 30pt 10.35%;"></div><div style="max-width:100%;padding-left:10.35%;padding-right:10.35%;position:relative;"><div style="clear:both;max-width:100%;position:relative;"><a id="_ab6beffa_f7a1_4cc2_bb03_e6601a1cf34e"></a><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt 0pt 12pt 0pt;"><b style="font-weight:bold;">SIGNATURE</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt;">Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p><table style="border-collapse:collapse;font-size:16pt;height:max-content;margin-left:auto;margin-right:auto;padding-left:0pt;padding-right:0pt;width:100%;"><tr><td style="vertical-align:bottom;width:50%;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 colspan="2" style="vertical-align:bottom;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;">PASSAGE BIO, INC.</b></p></td></tr><tr><td style="vertical-align:bottom;width:50%;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:3.99%;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:46%;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></tr><tr><td style="vertical-align:bottom;width:50%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">Date: December 17, 2021</p></td><td style="vertical-align:bottom;width:3.99%;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:bottom;width:46%;border-bottom:1px solid #000000;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">/s/ Simona King</p></td></tr><tr><td style="vertical-align:bottom;width:50%;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:3.99%;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:46%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">Simona King</p></td></tr><tr><td style="vertical-align:bottom;width:50%;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:3.99%;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:46%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">Chief Financial Officer</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="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;margin-bottom:30pt;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:24pt 0pt 0pt 0pt;">4</p></div></div>
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​
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):
December 17, 2021
PASSAGE BIO, INC.
(Exact name of registrant as specified in its charter)
​
​
​
​
Delaware
001-39231
82-2729751
(State or other jurisdiction
of incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)
​
​
​
One Commerce Square
2005 Market Street, 39
th
Floor
Philadelphia
,
PA
19103
(Address of principal executive offices)
(Zip Code)
​
(
267
)
866-0311
(Registrant's telephone number, including area code)
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, $0.0001 Par Value Per Share
PASG
The Nasdaq Stock Market LLC
(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 7.01 Regulation FD Disclosure.
​
On December 17, 2021, Passage Bio, Inc. (the "
Company
"), issued a press release announcing positive interim safety and 30-day biomarker data for cohort 1 of its global Phase 1/2 clinical trial for PBGM01 ("
Imagine-1
") for the treatment of early and late  infantile GM1 Gangliosidosis ("
GM1
"). A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K, which is incorporated herein by reference.
​
On December 17, 2021, the Company will also give a presentation describing its positive interim safety and 30-day biomarker data for cohort 1 of Imagine-1. A copy of this presentation is attached as Exhibit 99.2 to this Current Report on Form 8-K, which is incorporated herein by reference.
​
The information in this Item 7.01, including Exhibits 99.1 and 99.2 to this report, shall not be deemed to be "filed" for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act. The information contained in this Item 7.01 and in the accompanying Exhibits 99.1 and 99.2 shall not be incorporated by reference into any other filing under the Exchange Act or under the Securities Act, except as shall be expressly set forth by specific reference in such filing.
​
Item 8.01 Other Events.
​
PBGM01 Program Updates
​
The Company announced the following updates with respect to Imagine-1 for the treatment of early and late infantile GM1:
​
·
The Independent Data Monitoring Committee (the
"
IDMC
") recommended proceeding with two additional planned cohorts in the Imagine-1 clinical study.
​
·
Based on the IDMC recommendation, the Company has initiated recruitment in parallel for both a high-dose cohort of patients with late infantile GM1 (cohort 2) and a low-dose cohort of patients with early infantile GM1 (cohort 3).
​
·
Topline interim results from the Imagine-1 cohort 1, consisting of two patients (patient 1 data through eight months and patient 2 data through two months), showed:
​
o
With respect to safety, no serious adverse events were reported, and the reported adverse events were all mild to moderate. All moderate adverse events resolved without intervention and were deemed not to be treatment related. No complications related to intra cisterna magna injection were observed, and there was no evidence of dorsal root ganglion toxicity in nerve conduction studies.
​
o
With respect to beta-galactosidase enzyme activity levels, following PBGM01 administration, beta-galactosidase activity in cerebrospinal fluid ("
CSF
") and serum increased in both patients.
​
In CSF, for patient 1, enzyme activity at 30 days was 1.5-fold over baseline and the increase was maintained at six months. For patient 2, enzyme activity at 30 days was 4.8-fold over baseline.
​
In serum, for patient 1, enzyme activity was slightly above baseline at 30 days, 1.7-fold over baseline at three months and the increase was maintained at six months. For patient 2, enzyme activity at 30 days was 1.2-fold over baseline.
​
​
​
​
2
o
With respect to GM1 gangliosides in CSF, large differences were observed at baseline, with patient 2 showing baseline values four times higher than patient 1. For patient 1, levels increased approximately 85 percent at 30 days and remained stable at that level at six months. For patient 2, levels decreased approximately 46 percent at 30 days consistent with high increases in CSF enzyme activity.
​
Other Updates
​
On December 8, 2021, the Company announced that it had exercised two additional options under the research, collaboration and licensing agreement with the Trustees of the University of Pennsylvania for programs in Huntington's disease and Canavan disease.  The Company also announced that it expects to dose the first patients in global Phase 1/2 trials for frontotemporal dementia with granulin mutations and Krabbe disease in early 2022, and to provide updated guidance on the timing of data readouts for these two studies after the first patients have been dosed.
​
Item 9.01
Financial Statements and Exhibits.
​
(d) Exhibits
​
Exhibit No.
Description
99.1
​
Passage Bio, Inc. press release dated December 17, 2021.
99.2
​
Corporate Presentation.
104
​
Cover Page Interactive Data File (formatted as Inline XBRL).
​
​
​
3
SIGNATURE
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.
​
​
PASSAGE BIO, INC.
​
​
​
Date: December 17, 2021
By:
/s/ Simona King
​
​
Simona King
​
​
Chief Financial Officer
​
​
​
4