<SEC-DOCUMENT>0001193125-20-159486.txt : 20200603
<SEC-HEADER>0001193125-20-159486.hdr.sgml : 20200603
<ACCEPTANCE-DATETIME>20200603160155
ACCESSION NUMBER:		0001193125-20-159486
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20200603
ITEM INFORMATION:		Other Events
FILED AS OF DATE:		20200603
DATE AS OF CHANGE:		20200603

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			INOVIO PHARMACEUTICALS, INC.
		CENTRAL INDEX KEY:			0001055726
		STANDARD INDUSTRIAL CLASSIFICATION:	SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
		IRS NUMBER:				330969592
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-14888
		FILM NUMBER:		20939950

	BUSINESS ADDRESS:	
		STREET 1:		6769 MESA RIDGE RD.
		CITY:			SAN DIEGO
		STATE:			CA
		ZIP:			92121
		BUSINESS PHONE:		8584103134

	MAIL ADDRESS:	
		STREET 1:		6769 MESA RIDGE RD.
		CITY:			SAN DIEGO
		STATE:			CA
		ZIP:			92121

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	INOVIO BIOMEDICAL CORP
		DATE OF NAME CHANGE:	20050404

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	GENETRONICS BIOMEDICAL CORP
		DATE OF NAME CHANGE:	20011116

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	GENETRONICS BIOMEDICAL LTD
		DATE OF NAME CHANGE:	19980213
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>d937207d8k.htm
<DESCRIPTION>8-K
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 <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P>
<P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P> <P STYLE="margin-top:4pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>UNITED STATES </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>SECURITIES AND EXCHANGE COMMISSION </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Washington, DC 20549 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>FORM <FONT
STYLE="white-space:nowrap">8-K</FONT> </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>CURRENT
REPORT </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Pursuant to Section&nbsp;13 or 15(d) </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>of the Securities Exchange Act of 1934 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Date of Report (Date of earliest event reported): June&nbsp;3, 2020 </B></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center> <P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:24pt; font-family:Times New Roman" ALIGN="center"><B>Inovio Pharmaceuticals, Inc. </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>(Exact name of registrant as specified in its charter) </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top" ALIGN="center"><B><FONT STYLE="white-space:nowrap">001-14888</FONT></B></TD>
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<TD VALIGN="top" ALIGN="center"><B><FONT STYLE="white-space:nowrap">33-0969592</FONT></B></TD></TR>
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<TD VALIGN="top" ALIGN="center"><B>(State or other jurisdiction<BR>of incorporation)</B></TD>
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<TD VALIGN="top" ALIGN="center"><B>(Commission<BR>File Number)</B></TD>
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<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(IRS Employer</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>Identification No.)</B></P></TD></TR>
</TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>660 W. Germantown Pike, Suite 110 </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Plymouth Meeting, PA 19462 </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Address of principal executive offices, including zip code) </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>(267) <FONT STYLE="white-space:nowrap">440-4200</FONT> </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Registrant&#146;s telephone number, including area code) </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>N/A </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Former name or
former address, if changed since last report) </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Check the appropriate box below
if the Form <FONT STYLE="white-space:nowrap">8-K</FONT> filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: </P>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) </P></TD></TR></TABLE>
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<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Soliciting material pursuant to Rule <FONT STYLE="white-space:nowrap">14a-12</FONT> under the Exchange Act (17
CFR <FONT STYLE="white-space:nowrap">240.14a-12)</FONT> </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><FONT STYLE="white-space:nowrap">Pre-commencement</FONT> communications pursuant to Rule <FONT
STYLE="white-space:nowrap">14d-2(b)</FONT> under the Exchange Act (17 CFR <FONT STYLE="white-space:nowrap">240.14d-2(b))</FONT> </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><FONT STYLE="white-space:nowrap">Pre-commencement</FONT> communications pursuant to Rule <FONT
STYLE="white-space:nowrap">13e-4(c)</FONT> under the Exchange Act (17 CFR <FONT STYLE="white-space:nowrap">240.13e-4(c))</FONT> </P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Securities registered pursuant to Section&nbsp;12(b) of the Act: </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="bottom">&nbsp;</TD>
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<TD VALIGN="top" ALIGN="center"><B>Common Stock, $0.001 par value</B></TD>
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<TD VALIGN="top" ALIGN="center"><B>INO</B></TD>
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<TD VALIGN="top" ALIGN="center"><B>The Nasdaq Stock Market LLC</B></TD></TR>
</TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">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 <FONT STYLE="white-space:nowrap">12b-2</FONT> of the Securities Exchange Act of 1934 <FONT STYLE="white-space:nowrap">(&#167;240.12b-2</FONT> of this chapter). </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Emerging growth company&nbsp;&nbsp;&#9744; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">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&nbsp;13(a) of the Exchange
Act.&nbsp;&nbsp;&#9744; </P> <P STYLE="font-size:10pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P> <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Item 8.01. Other Events. </U></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">On June&nbsp;3, 2020, Inovio Pharmaceuticals, Inc. (the &#147;<B><I>Company</I></B>&#148;) filed a complaint in the Court of Common Pleas of Montgomery County,
Pennsylvania seeking, among other requests for emergency relief, to compel VGXI, Inc. and GeneOne Life Science, Inc. (together, &#147;<B><I>VGXI</I></B>&#148;) to facilitate the transfer of manufacturing methods, using VGXI&#146;s technology, under
the parties&#146; existing supply agreement (the &#147;<B><I>Supply Agreement</I></B>&#148;). The technology transfer, which the Company has requested as permitted under the Supply Agreement, will allow for the large-scale manufacture of the
Company&#146;s product candidate <FONT STYLE="white-space:nowrap">INO-4800,</FONT> a new vaccine candidate against the disease, known as <FONT STYLE="white-space:nowrap">COVID-19,</FONT> caused by the outbreak strain of the coronavirus <FONT
STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">SARS-CoV-2.</FONT></FONT> The Company believes that widespread availability of its potential <FONT STYLE="white-space:nowrap">COVID-19</FONT> vaccine, which can only be achieved through
accelerated large-scale manufacture following clinical trials and regulatory approval, is essential to combat the ongoing global coronavirus pandemic. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">As
described in the Company&#146;s Annual Report on Form <FONT STYLE="white-space:nowrap">10-K</FONT> for the year ended December&nbsp;31, 2019, filed with the U.S. Securities and Exchange Commission on March&nbsp;12, 2020, the Company and VGXI entered
into the Supply Agreement in 2008. Under the Supply Agreement, VGXI produces and supplies the DNA plasmids for the Company&#146;s research and early clinical trials for its product candidates. There are no purchase commitments by the Company under
the Supply Agreement; rather, terms of purchase are determined on an individual purchase order basis. Under the Supply Agreement, the Company has agreed to treat VGXI as its most favored supplier for DNA plasmids, and VGXI has agreed to treat the
Company as its most favored customer. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In January 2020, the Company began preclinical studies of <FONT STYLE="white-space:nowrap">INO-4800</FONT> in an
effort to develop a potential vaccine for an urgent public health need. In April 2020, the Company received approval from the U.S. Food and Drug Administration (the &#147;<B><I>FDA</I></B>&#148;) to begin a Phase 1 clinical trial of <FONT
STYLE="white-space:nowrap">INO-4800.</FONT> If the initial safety and immunogenicity data from the Phase 1 trial are acceptable, the Company plans to advance the development of <FONT STYLE="white-space:nowrap">INO-4800</FONT> into later-stage
efficacy trials in the second half of 2020, subject to further regulatory guidance from the FDA. The Company has a goal of producing one million doses of <FONT STYLE="white-space:nowrap">INO-4800</FONT> by the end of 2020, with its existing capacity
and contract resources, for further clinical trials or emergency use. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">VGXI informed the Company that it did not have the capacity to manufacture the
Company&#146;s full order of DNA plasmids on the requested timeline, nor would it be able to manufacture plasmids for the commercial sale of <FONT STYLE="white-space:nowrap">INO-4800,</FONT> if it were to be approved for sale. The Company began
discussions with other third-party contract manufacturers, as permitted by the Supply Agreement. As previously announced, in March and April 2020, the Company engaged Ology Bioservices Inc. and Richter-Helm BioLogics GmbH&nbsp;&amp; Co. KG to
support large-scale manufacturing of <FONT STYLE="white-space:nowrap">INO-4800.</FONT> Richter-Helm BioLogics has manufactured the Company&#146;s DNA medicine candidate <FONT STYLE="white-space:nowrap">VGX-3100,</FONT> currently in Phase 3 trials as
a potential treatment for precancerous cervical dysplasia, since 2015 using a process technology that was transferred by VGXI at that time. The Company intends to engage additional contract manufacturers for the production of <FONT
STYLE="white-space:nowrap">INO-4800.</FONT> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Following notification of VGXI&#146;s insufficient capacity, the Company requested that VGXI provide the
necessary technology transfer materials in order to allow its engaged contract manufacturers to proceed with the manufacture of <FONT STYLE="white-space:nowrap">INO-4800,</FONT> as required by the Supply Agreement. In May 2020, following further
discussions between the parties, VGXI notified the Company of its refusal to undertake the Company&#146;s request, leading the Company to initiate legal proceedings as an emergency action to compel the technology transfer required of VGXI by the
Supply Agreement for the planned large-scale manufacture of the Company&#146;s <FONT STYLE="white-space:nowrap">COVID-19</FONT> vaccine candidate. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Forward-Looking Statements </U></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">This report contains certain
forward-looking statements relating to the Company&#146;s business that involve a number of risks and uncertainties, including statements related to expected development and manufacturing of its vaccine candidate
<FONT STYLE="white-space:nowrap">INO-4800.</FONT> These statements may be identified by introductory words such as &#147;may,&#148; &#147;expects,&#148; &#147;plan,&#148; &#147;believe,&#148; &#147;will,&#148; &#147;achieve,&#148;
&#147;anticipate,&#148; &#147;would,&#148; &#147;should,&#148; &#147;subject to&#148; or words of similar meaning, or by the fact that they do not relate strictly to historical or current facts. For such statements, the Company claims the protection
of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including, but not limited to, the risk that the Company may not be able to
procure the necessary contract manufacturing capacity in order to sufficiently produce <FONT STYLE="white-space:nowrap">INO-4800</FONT> on the planned timeline, as well as other factors discussed in the &#147;Risk Factors&#148; section of the
Company&#146;s most recently filed Annual Report on Form <FONT STYLE="white-space:nowrap">10-K</FONT> or Quarterly Report on Form <FONT STYLE="white-space:nowrap">10-Q,</FONT> as well as other filings that the Company makes with the SEC from time to
time. There can be no assurance that any of the forward-looking information provided herein will be proven accurate. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In addition, the forward-looking statements included in this report represent the Company&#146;s views as of
the date hereof. The Company anticipates that subsequent events and developments may cause its views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the company specifically
disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company&#146;s views as of any date subsequent to the date of this report. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>SIGNATURES </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">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-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top" COLSPAN="3"><B>INOVIO PHARMACEUTICALS, INC.</B></TD></TR>
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<TD VALIGN="top">Date: June&nbsp;3, 2020</TD>
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<TD VALIGN="top">By:</TD>
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<TD VALIGN="top"> <P STYLE="margin-top:0pt; margin-bottom:1pt; border-bottom:1px solid #000000; font-size:10pt; font-family:Times New Roman">/s/ Peter Kies</P></TD></TR>
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<TD VALIGN="top">Peter Kies</TD></TR>
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<TD VALIGN="bottom">&nbsp;</TD>
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<TD VALIGN="top">Chief Financial Officer</TD></TR>
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