<SEC-DOCUMENT>0001193125-17-186271.txt : 20170530
<SEC-HEADER>0001193125-17-186271.hdr.sgml : 20170530
<ACCEPTANCE-DATETIME>20170530070856
ACCESSION NUMBER:		0001193125-17-186271
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20170526
ITEM INFORMATION:		Entry into a Material Definitive Agreement
FILED AS OF DATE:		20170530
DATE AS OF CHANGE:		20170530

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Protagonist Therapeutics, Inc
		CENTRAL INDEX KEY:			0001377121
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				980505495
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-37852
		FILM NUMBER:		17875596

	BUSINESS ADDRESS:	
		STREET 1:		7707 GATEWAY BLVD., SUITE 140
		CITY:			NEWARK
		STATE:			CA
		ZIP:			94560-1160
		BUSINESS PHONE:		(510) 474-0170

	MAIL ADDRESS:	
		STREET 1:		7707 GATEWAY BLVD., SUITE 140
		CITY:			NEWARK
		STATE:			CA
		ZIP:			94560-1160

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	Protagonist Therapeutics Inc
		DATE OF NAME CHANGE:	20130605

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	Protagonist Inc
		DATE OF NAME CHANGE:	20061002
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>d406513d8k.htm
<DESCRIPTION>FORM 8-K
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<TITLE>Form 8-K</TITLE>
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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, D.C. 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): May&nbsp;26, 2017 </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>PROTAGONIST THERAPEUTICS, 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>Delaware</B></TD>
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<TD VALIGN="top" ALIGN="center"><B><FONT STYLE="white-space:nowrap">001-37852</FONT></B></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"><B><FONT STYLE="white-space:nowrap">98-0505495</FONT></B></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:8pt">
<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(State or other jurisdiction</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>of incorporation)</B></P></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Commission</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>File Number)</B></P></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<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>Protagonist Therapeutics, Inc. </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>7707 Gateway Blvd., Suite 140 </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Newark, California 94560-1160 </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>(510) <FONT STYLE="white-space:nowrap">474-0170</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>Not Applicable </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; text-indent:4%; 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 WIDTH="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top">Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) </TD></TR></TABLE> <P STYLE="font-size:6pt;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="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top">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> </TD></TR></TABLE>
<P STYLE="font-size:6pt;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="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top"><FONT STYLE="white-space:nowrap">Pre-commencement</FONT> communications pursuant to <FONT STYLE="white-space:nowrap">Rule&nbsp;14d-2(b)</FONT> under the Exchange Act (17 CFR
<FONT STYLE="white-space:nowrap">240.14d-2(b))</FONT> </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="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top"><FONT STYLE="white-space:nowrap">Pre-commencement</FONT> communications pursuant to <FONT STYLE="white-space:nowrap">Rule&nbsp;13e-4(c)</FONT> under the Exchange Act (17 CFR
<FONT STYLE="white-space:nowrap">240.13e-4(c))</FONT> </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" ALIGN="right">Emerging growth company&nbsp;&nbsp;&#9746; </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 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> <P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P>

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<TD WIDTH="10%" VALIGN="top" ALIGN="left"><B>Item&nbsp;1.01.</B></TD>
<TD ALIGN="left" VALIGN="top"><B>Entry into a Material Definitive Agreement. </B></TD></TR></TABLE> <P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:8%; font-size:10pt; font-family:Times New Roman">On May&nbsp;26, 2017, Protagonist
Therapeutics, Inc. (&#147;Protagonist&#148; or &#147;the Company&#148;) and Janssen Biotech, Inc., a Pennsylvania corporation (&#147;Janssen&#148;), entered into an exclusive license and collaboration agreement (the &#147;Collaboration
Agreement&#148;) for the development, manufacture and commercialization of <FONT STYLE="white-space:nowrap">PTG-200</FONT> worldwide for the treatment of Crohn&#146;s disease (&#147;CD&#148;) and ulcerative colitis (&#147;UC&#148;). <FONT
STYLE="white-space:nowrap">PTG-200</FONT> is the Company&#146;s oral Interleukin <FONT STYLE="white-space:nowrap">(&#147;IL&#148;)-23</FONT> receptor antagonist drug candidate currently in <FONT STYLE="white-space:nowrap">pre-clinical</FONT>
development. The effectiveness of the Collaboration Agreement is subject to the expiration or termination of all applicable waiting periods under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:8%; font-size:10pt; font-family:Times New Roman">Under the Collaboration Agreement, Protagonist would grant to Janssen an exclusive worldwide license to develop, manufacture and commercialize
<FONT STYLE="white-space:nowrap">PTG-200</FONT> and related <FONT STYLE="white-space:nowrap">IL-23</FONT> receptor inhibitor compounds for all indications, including CD and UC. The Company will be responsible, at its own expense, for the conduct of
the Phase 1 clinical trial for <FONT STYLE="white-space:nowrap">PTG-200,</FONT> and Janssen will be responsible for the conduct of a Phase 2 clinical trial for <FONT STYLE="white-space:nowrap">PTG-200</FONT> in CD. All such clinical trials would be
conducted in accordance with a mutually agreed upon clinical development plan and budget. Development costs for the Phase 2 clinical trial would be shared between the parties on an 80% Janssen and 20% Protagonist basis. Should Janssen elect to
retain its license following completion of the Phase 2 clinical trial, it would be responsible for the manufacture, continued development of, seeking regulatory approval for, and commercialization of <FONT STYLE="white-space:nowrap">PTG-200</FONT>
worldwide. The parties&#146; development activities under the Collaboration Agreement through the Phase 2 clinical trial will be overseen by a joint governance structure which will have equal representation by both parties. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:8%; font-size:10pt; font-family:Times New Roman">Upon the effectiveness of the Collaboration Agreement, Janssen would pay Protagonist $50&nbsp;million as an initial payment. Following the
conclusion of the planned Phase 2A portion of the Phase 2 clinical trial, if Janssen elects to maintain its license rights and continue the development of <FONT STYLE="white-space:nowrap">PTG-200</FONT> in the Phase 2B portion of such clinical trial
(the &#147;First Opt-in&#148;), Protagonist would receive a $125&nbsp;million payment. Following the conclusion of the planned Phase 2B portion of the Phase 2 clinical trial, if Janssen elects again to maintain its license rights (the &#147;Second
Opt-in&#148;), Protagonist would receive a $200&nbsp;million payment. Protagonist is eligible to receive additional potential regulatory and sales milestone payments of up to an aggregate of $615&nbsp;million and tiered royalties paid as a
percentage of Janssen&#146;s worldwide net sales at rates ranging from ten to the <FONT STYLE="white-space:nowrap">mid-teens,</FONT> with certain customary reductions in certain circumstances. If Janssen does not make either the First Opt-in or the
Second Opt-in election, the Collaboration Agreement would terminate. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:8%; font-size:10pt; font-family:Times New Roman">Protagonist would also have an option to provide up to 30% of the
required U.S. details for <FONT STYLE="white-space:nowrap">PTG-200</FONT> to prescribers, using its own sales force personnel, upon commercial launch in the United States. If such right is exercised, the Company&#146;s detailing costs would be
reimbursed by Janssen. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:8%; font-size:10pt; font-family:Times New Roman">The Collaboration Agreement contains customary representations, warranties and covenants by Protagonist and
Janssen and includes an obligation by Protagonist not to develop or commercialize other compounds which also target the <FONT STYLE="white-space:nowrap">IL-23</FONT> receptor outside of the Collaboration Agreement until completion of the Phase 2B
portion of the Phase 2 clinical trial. Each of Protagonist and Janssen is required to indemnify the other party against all losses and expenses relating to breaches of its representations, warranties and covenants. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:8%; font-size:10pt; font-family:Times New Roman">The Collaboration Agreement would remain in effect until the royalty obligations cease following patent and regulatory expiry, unless
terminated earlier. Either Protagonist or Janssen may terminate the Collaboration Agreement for uncured material breach. Janssen retains the right to terminate the Collaboration Agreement for convenience and without cause on written notice of a
certain period. Upon a termination of the Collaboration Agreement, all rights revert back to Protagonist, and in certain circumstances, if such termination occurs during ongoing clinical trials, Janssen would, if requested, provide certain financial
and operational support to Protagonist for the completion of such trials. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:8%; font-size:10pt; font-family:Times New Roman">The foregoing description of the Collaboration Agreement and
the transactions contemplated thereby does not purport to be complete and is subject to, and qualified in its entirety by reference to, the complete text of the Collaboration Agreement, which will be filed with the Securities and Exchange Commission
(the &#147;SEC&#148;). </P>

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 <P STYLE="margin-top:0pt; margin-bottom:0pt; text-indent:8%; font-size:10pt; font-family:Times New Roman">With the additional funding from this collaboration, Protagonist believes it has the financial
resources to fund all ongoing and planned research and development activities until the middle of 2019. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Forward-Looking Statements </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:8%; font-size:10pt; font-family:Times New Roman">This Current Report on Form <FONT STYLE="white-space:nowrap">8-K</FONT> contains forward-looking statements for purposes of the &#147;safe
harbor&#148; provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding Protagonist&#146;s intentions or current expectations concerning, among other things, the potential for
its programs, the timing of its clinical trials, the potential for eventual regulatory approval and commercialization of its product candidates, its potential receipt of milestone payments and royalties under its collaboration agreement with Janssen
and the adequacy of its financial resources. In some cases you can identify these statements by forward-looking words such as &#147;may,&#148; &#147;will,&#148; &#147;continues,&#148; &#147;expects,&#148; &#147;believes,&#148; &#147;potential,&#148;
or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from
those anticipated, including, but not limited to, Protagonist&#146;s history of net operating losses, its reliance on third parties and uncertainty regarding its ability to achieve profitability, its ability to develop and commercialize its product
candidates, its ability to use and expand its programs to build a pipeline of product candidates, its ability to obtain and maintain regulatory approval of its product candidates, its ability to operate in a competitive industry and compete
successfully against competitors that have greater resources, and its ability to obtain and adequately protect intellectual property rights for its product candidates. The Company discusses many of these risks in greater detail under the heading
&#147;Risk Factors&#148; contained in its Quarterly Report on Form <FONT STYLE="white-space:nowrap">10-Q</FONT> for the quarter ended March&nbsp;31, 2017, filed with the SEC on May&nbsp;10, 2017. Undue reliance should not be placed on
forward-looking statements, which speak only as of the date they are made, and the facts and assumptions underlying the forward-looking statements may change. Except as required by law, Protagonist disclaims any obligation to update these
forward-looking statements to reflect future information, events or circumstances. </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; text-indent:4%; 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>Protagonist Therapeutics, Inc.</B></TD></TR>
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<TD VALIGN="top">Dated: May&nbsp;30, 2017</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/ Dinesh V. Patel, Ph.D.</P></TD></TR>
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<TD VALIGN="top">Dinesh V. Patel, Ph.D.</TD></TR>
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<TD VALIGN="top">President and Chief Executive Officer</TD></TR>
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