<SEC-DOCUMENT>0001193125-20-119137.txt : 20200601
<SEC-HEADER>0001193125-20-119137.hdr.sgml : 20200601
<ACCEPTANCE-DATETIME>20200424163056
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0001193125-20-119137
CONFORMED SUBMISSION TYPE:	CORRESP
PUBLIC DOCUMENT COUNT:		2
FILED AS OF DATE:		20200424

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:		CORRESP

	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>
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<IMG SRC="g921560g68i60.jpg" ALT="LOGO">
 </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Brian F. Leaf </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">(703) <FONT
STYLE="white-space:nowrap">456-8053</FONT> </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">bleaf@cooley.com </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="right">VIA EDGAR </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">April&nbsp;24, 2020 </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">U.S. Securities and Exchange Commission </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Division of Corporation
Finance </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Office of Life Sciences </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">100 F Street, N.E. </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Washington, DC 20549 </P>
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<TD WIDTH="5%" VALIGN="top" ALIGN="left">Attn:</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Tracey McKoy </P></TD></TR></TABLE>
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<TR style = "page-break-inside:avoid">
<TD WIDTH="5%" VALIGN="top" ALIGN="left">&nbsp;&nbsp;&nbsp;&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Terence O&#146;Brien </P></TD></TR></TABLE>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TR style = "page-break-inside:avoid">
<TD WIDTH="5%" VALIGN="top" ALIGN="left">Re:</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Inovio Pharmaceuticals, Inc. </P></TD></TR></TABLE>
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<TR style = "page-break-inside:avoid">
<TD WIDTH="5%" VALIGN="top" ALIGN="left">&nbsp;&nbsp;&nbsp;&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Form <FONT STYLE="white-space:nowrap">10-K</FONT> for the Fiscal Year Ended December&nbsp;31, 2019
</P></TD></TR></TABLE>
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<TD WIDTH="5%" VALIGN="top" ALIGN="left">&nbsp;&nbsp;&nbsp;&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">File <FONT STYLE="white-space:nowrap">No.&nbsp;001-14888</FONT> </P></TD></TR></TABLE>
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<TR style = "page-break-inside:avoid">
<TD WIDTH="5%" VALIGN="top" ALIGN="left">&nbsp;&nbsp;&nbsp;&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Filed March&nbsp;12, 2020 </P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Ladies and Gentlemen: </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">On behalf of our client, Inovio
Pharmaceuticals, Inc. (the &#147;<B>Company</B>&#148;), we are responding to the comments of the staff (the &#147;<B>Staff</B>&#148;) of the Securities and Exchange Commission (the &#147;<B>Commission</B>&#148;) contained in its letter dated
April&nbsp;14, 2020 (the &#147;<B>Comment Letter</B>&#148;), relating to the above referenced Form <FONT STYLE="white-space:nowrap">10-K</FONT> for the Fiscal Year Ended December&nbsp;31, 2019 (the &#147;<B>Form</B>
<B><FONT STYLE="white-space:nowrap">10-K</FONT></B>&#148;). In response to the comments set forth in the Comment Letter (the &#147;<B>Comments</B>&#148;), the Company has submitted this response letter. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Set forth below are the Company&#146;s responses to the Comments. The numbering of the paragraphs below corresponds to the numbering of the Comments, which
for your convenience we have incorporated into this response letter. Page references in the text of this response letter correspond to page numbers of the <FONT STYLE="white-space:nowrap">10-K.</FONT> </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><U>Item 15. Exhibits, Financial Statements Schedules, page 81 </U></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="5%" VALIGN="top" ALIGN="left"><I>1.</I></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><I>You disclose that you are collaborating with Beijing Advaccine Biotechnology Co. to advance the development
of <FONT STYLE="white-space:nowrap">INO-4800,</FONT> your new coronavirus vaccine candidate, and your goal is to produce up to one million doses of a potential vaccine by the end of 2020. If this agreement represents a material contract pursuant to
Item 601(b)(10) of Regulation <FONT STYLE="white-space:nowrap">S-K,</FONT> please file such contract as an exhibit or provide an analysis supporting your determination that you are not required to provide the contract. </I></P></TD></TR></TABLE>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TR style = "page-break-inside:avoid">
<TD WIDTH="5%" VALIGN="top" ALIGN="left"><B>&nbsp;&nbsp;&nbsp;&nbsp;</B></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><B>Response: </B>The Company respectfully advises the Staff that it does not believe that its license and
collaboration agreement (the &#147;<B>BAB</B> <B>Agreement</B>&#148;) with Beijing Advaccine Biotechnology Co. and its affiliated entities (collectively, &#147;<B>Advaccine</B>&#148;) is required to be filed as an exhibit pursuant to Item 601(b)(10)
of Regulation <FONT STYLE="white-space:nowrap">S-K.</FONT> In accordance with Item 601(b)(10)(ii)(B) of Regulation <FONT STYLE="white-space:nowrap">S-K,</FONT> an agreement that was entered into in the ordinary course of business is not required to
be filed as an exhibit unless it is a &#147;contract upon which the registrant&#146;s business is <I>substantially dependent</I>, as in the case of continuing contracts to sell the major part of registrant&#146;s products or services or to purchase
the major part of registrant&#146;s requirements of goods, services or raw materials or any franchise or license or other agreement to use a patent, formula, trade secret, process or trade name upon which registrant&#146;s business depends to a
material extent&#148; (emphasis added). </P></TD></TR></TABLE> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="5%" VALIGN="top" ALIGN="left">&nbsp;&nbsp;&nbsp;&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">The Company submits that the BAB Agreement is of the type that ordinarily accompanies the Company&#146;s
business of developing pharmaceutical product candidates and should therefore be deemed, pursuant to Item 601(b)(ii) of Regulation <FONT STYLE="white-space:nowrap">S-K,</FONT> to have been made in the ordinary course of business. As described in
detail in the Form <FONT STYLE="white-space:nowrap">10-K,</FONT> the Company&#146;s corporate strategy is to advance, protect, and once approved, commercialize its novel DNA medicines to meet urgent and emerging global health needs. The Company is
advancing an array of DNA medicine candidates that target <FONT STYLE="white-space:nowrap">HPV-related</FONT> diseases, cancer and infectious diseases, including the disease known as Coronavirus Disease 2019, or
<FONT STYLE="white-space:nowrap">COVID-19,</FONT> caused by the <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">SARS-CoV-2</FONT></FONT> virus. As shown on pages 2 and 67 of the Form <FONT STYLE="white-space:nowrap">10-K,</FONT>
the Company has entered into collaborations with nearly 20 third parties to conduct clinical trials of the Company&#146;s product candidates. </P></TD></TR></TABLE>
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<TD WIDTH="5%" VALIGN="top" ALIGN="left">&nbsp;&nbsp;&nbsp;&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">With respect to the clinical development of its coronavirus vaccine candidate,
<FONT STYLE="white-space:nowrap">INO-4800,</FONT> the Company intends to pursue the development of this candidate in the United States as well as in China and South Korea. The Company&#146;s collaboration with Advaccine relates only to the conduct
of clinical trials in China. As noted in the Company&#146;s Current Report on Form <FONT STYLE="white-space:nowrap">8-K</FONT> filed on April&nbsp;6, 2020, the Company has begun a Phase 1 clinical trial of
<FONT STYLE="white-space:nowrap">INO-4800</FONT> in healthy volunteers at two sites in the United States. The clinical trial being conducted in the United States is being funded by grants from Coalition for Epidemic Preparedness Innovations (CEPI)
and the Bill and Melinda Gates Foundation and is not being conducted in collaboration with Advaccine. By press release issued on April&nbsp;16, 2020, the Company announced that it has received additional grant funding from CEPI to conduct a Phase
1/2 clinical trial of <FONT STYLE="white-space:nowrap">INO-4800</FONT> in South Korea. The planned clinical trial in South Korea is also not the subject of the Company&#146;s collaboration with Advaccine. </P></TD></TR></TABLE>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TR style = "page-break-inside:avoid">
<TD WIDTH="5%" VALIGN="top" ALIGN="left">&nbsp;&nbsp;&nbsp;&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">As of the date hereof, the Company advises the Staff that the clinical trial of
<FONT STYLE="white-space:nowrap">INO-4800</FONT> in China has not commenced. The Company entered into the BAB Agreement in January 2020 to leverage Advaccine&#146;s clinical development expertise to run a Phase 1 trial in China in parallel with the
Company&#146;s clinical development efforts in the United States and South Korea. The Company and Advaccine will also collaborate to attract additional grant funding and further collaborations with larger vaccine companies in China. Under the BAB
Agreement, the Company&#146;s obligations are to, among other things, manufacture and supply <FONT STYLE="white-space:nowrap">INO-4800</FONT> for the planned clinical trial in China, while Advaccine is responsible for managing and conducting the
planned clinical trial in accordance with the agreed-upon development plan, with the trial funding to be provided by the Company up to a specified amount that is not material to the Company. If clinical development of
<FONT STYLE="white-space:nowrap">INO-4800</FONT> in China does progress beyond a Phase 1 clinical trial, pursuant to the terms of the Agreement the Company may, but is not obligated to, fund further clinical development or commercialization, if
approved, of <FONT STYLE="white-space:nowrap">INO-4800</FONT> in China. In addition, the Company would share with Advaccine, in certain circumstances, a specified portion of any royalties and milestone payments that the Company may receive in
consideration of licenses or other commercial rights granted to third parties specific to <FONT STYLE="white-space:nowrap">INO-4800</FONT> only in China. </P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The Company submits that its collaboration with Advaccine is of no more significance than any of the other collaborations for the Company&#146;s other product
candidates described in the Form <FONT STYLE="white-space:nowrap">10-K.</FONT> As the BAB Agreement (i)&nbsp;relates to development of <FONT STYLE="white-space:nowrap">INO-4800</FONT> only in China, (ii)&nbsp;does not involve any material financial
obligations of the Company or, in the near term, any potential payments to the Company, (iii)&nbsp;is one of many collaboration agreements that ordinarily accompanies the type of business conducted by the Company and (iv)&nbsp;relates to just one of
many product candidates being developed by the Company, the Company respectfully advises the Staff that it is not substantially dependent on the BAB Agreement and as a result does not consider it to a material contract within the meaning of Item
601(b)(10)(ii)(B) of Regulation <FONT STYLE="white-space:nowrap">S-K.</FONT> </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Please direct any questions or comments concerning the Form <FONT STYLE="white-space:nowrap">10-K</FONT> or
this response letter to either the undersigned at (703) <FONT STYLE="white-space:nowrap">456-8053</FONT> or Darah Protas at (202) <FONT STYLE="white-space:nowrap">962-8332.</FONT> </P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><DIV ALIGN="right">
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<TD VALIGN="top">Very truly yours,</TD></TR>
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<TD HEIGHT="16"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<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/ Brian F. Leaf</P></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top">Brian F. Leaf</TD></TR>
</TABLE></DIV> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TR style = "page-break-inside:avoid">
<TD WIDTH="5%" VALIGN="top" ALIGN="left">cc:</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">J. Joseph Kim, Inovio Pharmaceuticals, Inc. </P></TD></TR></TABLE>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="5%" VALIGN="top" ALIGN="left">&nbsp;&nbsp;&nbsp;&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Peter Kies, Inovio Pharmaceuticals, Inc </P></TD></TR></TABLE>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="5%" VALIGN="top" ALIGN="left">&nbsp;&nbsp;&nbsp;&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Jeffrey P. Libson, Cooley LLP </P></TD></TR></TABLE>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="5%" VALIGN="top" ALIGN="left">&nbsp;&nbsp;&nbsp;&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Darah G. Protas, Cooley LLP </P></TD></TR></TABLE>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
