<SEC-DOCUMENT>0001171843-19-008007.txt : 20191209
<SEC-HEADER>0001171843-19-008007.hdr.sgml : 20191209
<ACCEPTANCE-DATETIME>20191209063015
ACCESSION NUMBER:		0001171843-19-008007
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20191209
FILED AS OF DATE:		20191209
DATE AS OF CHANGE:		20191209

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Innate Pharma SA
		CENTRAL INDEX KEY:			0001598599
		STANDARD INDUSTRIAL CLASSIFICATION:	BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			I0
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-39084
		FILM NUMBER:		191274262

	BUSINESS ADDRESS:	
		STREET 1:		117 AVENUE DE LUMINY
		STREET 2:		BP 30191
		CITY:			MARSEILLE
		STATE:			I0
		ZIP:			13009
		BUSINESS PHONE:		33430303030

	MAIL ADDRESS:	
		STREET 1:		117 AVENUE DE LUMINY
		STREET 2:		BP 30191
		CITY:			MARSEILLE
		STATE:			I0
		ZIP:			13009

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	Innate Pharma, SA
		DATE OF NAME CHANGE:	20140129
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<TYPE>6-K
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<FILENAME>f6k_120919.htm
<DESCRIPTION>FORM 6-K
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<P STYLE="font-size: 18pt; text-align: center; margin: 0pt 0"><B>UNITED STATES</B></P>

<P STYLE="font-size: 18pt; text-align: center; margin: 0pt 0"><B>SECURITIES AND EXCHANGE COMMISSION</B></P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0"><B>Washington, D.C. 20549</B></P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 18pt; text-align: center; margin: 0pt 0"><B>FORM&nbsp;6-K</B></P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0"><B>REPORT OF FOREIGN PRIVATE ISSUER </B></P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0"><B>PURSUANT TO RULE 13a-16 OR 15d-16 </B></P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0"><B>UNDER THE SECURITIES EXCHANGE ACT OF 1934</B></P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0"><B>Date of report: December 9, 2019</B></P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0"><B>&nbsp;</B></P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0"><B>Commission File Number: 001-39084</B></P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 18pt; text-align: center; margin: 0pt 0"><B>Innate Pharma S.A.</B></P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0">(Translation of registrant&rsquo;s name into English)</P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0"><B>Innate Pharma S.A. </B></P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0"><B>117 Avenue de Luminy&mdash;BP 30191 </B></P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0"><B>13009 Marseille, France </B></P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0"><B>+ 33 (0) 4 30 30 30 30 </B></P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0">(Address of principal executive office)</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; text-indent: 0.25in; margin: 0pt 0">Indicate by check mark whether the registrant files or will file
annual reports under cover of Form&nbsp;20-F or Form&nbsp;40-F:</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; text-indent: 0.25in; margin: 0pt 0">Form&nbsp;20-F &#9746;&nbsp;&nbsp;&nbsp;&nbsp;Form&nbsp;40-F &#9744;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; text-indent: 0.25in; margin: 0pt 0">Indicate by check mark if the registrant is submitting the Form&nbsp;6-K
on paper as permitted by Regulation S-T Rule&nbsp;101(b)(1): &#9744;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; text-indent: 0.25in; margin: 0pt 0">Indicate by check mark if the registrant is submitting the Form&nbsp;6-K
on paper as permitted by Regulation S-T Rule&nbsp;101(b)(7): &#9744;</P>

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<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0"><B>EXHIBIT LIST </B></P>

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        <P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0; border-bottom: black 1pt solid"><B>Description</B></P></TD></TR>
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    <TD STYLE="vertical-align: top; font-size: 10pt"><A HREF="exh_991.htm"><FONT STYLE="font-size: 10pt">99.1</FONT></A></TD>
    <TD STYLE="vertical-align: bottom; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="vertical-align: top; font-size: 10pt"><A HREF="exh_991.htm"><FONT STYLE="font-size: 10pt">Press Release dated December 8, 2019.</FONT></A></TD></TR>
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<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0"><B>SIGNATURES</B></P>

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<P STYLE="font-size: 10pt; text-indent: 0.25in; margin: 0pt 0">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, thereunto duly authorized.</P>

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    <TD COLSPAN="2"><FONT STYLE="font-size: 10pt"><B>INNATE PHARMA S.A.</B></FONT></TD></TR>
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    <TD STYLE="width: 51%">&nbsp;</TD>
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    <TD><FONT STYLE="font-size: 10pt">Date: December 9, 2019</FONT></TD>
    <TD><FONT STYLE="font-size: 10pt">By:</FONT></TD>
    <TD STYLE="border-bottom: black 1pt solid"><FONT STYLE="font-size: 10pt">/s/ Laure-H&eacute;l&egrave;ne Mercier</FONT></TD></TR>
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    <TD>&nbsp;</TD>
    <TD><FONT STYLE="font-size: 10pt">Name:&nbsp;&nbsp;</FONT></TD>
    <TD><FONT STYLE="font-size: 10pt">Laure-H&eacute;l&egrave;ne Mercier</FONT></TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD><FONT STYLE="font-size: 10pt">Title:</FONT></TD>
    <TD><FONT STYLE="font-size: 10pt">Chief Financial Officer</FONT></TD></TR>
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<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>exh_991.htm
<DESCRIPTION>PRESS RELEASE
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<!DOCTYPE HTML PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN"><html lang="en-US"><head><title>EdgarFiling</title><meta content="text/html; charset=windows-1252" ><meta name="GENERATOR" content="MSHTML 8.00.7601.18094" ></head><body bgcolor="#ffffff"><p style="text-align: right;"><strong>EXHIBIT 99.1</strong></p><p style="text-align: center;"><font style="font-size: 14pt;"><strong>Innate Pharma Highlights FDA-Approved Lumoxiti&#174; at ASH 2019</strong></font></p><p style="text-align: center;"><strong>Final analysis expands on efficacy results from pivotal Phase III trial of Lumoxiti in hairy cell leukemia; durable, complete responses maintained in long-term follow-up data</strong></p><p>
 <p>MARSEILLE, France, Dec.  08, 2019  (GLOBE NEWSWIRE) -- Innate Pharma SA (Euronext Paris: IPH &#8211; ISIN: FR0010331421; Nasdaq: IPHA) (&#8220;<strong>Innate</strong>&#8221; or the &#8220;<strong>Company</strong>&#8221;) shared new, long-term data from the pivotal Phase III trial of Lumoxiti (moxetumomab pasudotox-tdfk) today at the 61st American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, USA, which expands on the efficacy results and affirms the manageable safety profile of the medicine.&#160;</p>  <p align="justify">The final analysis showed that 36 percent (29/80) of the relapsed or refractory hairy cell leukemia patients achieved durable complete response (CR) with Lumoxiti at Day 181 of patients&#8217; respective evaluation, compared to the primary analysis in which 30 percent durable CR rate was reported. In addition, there was a 61 percent probability that patients who achieved a CR would maintain it after five years.&#160;</p>  <p align="justify"><em>&#8220;Lumoxiti is a first-in-class medicine and the only treatment&#160;approved in the US&#160;for&#160;relapsed or refractory&#160;hairy cell leukemia in more than twenty years; therefore, it is important for the hematology-oncology community to receive additional analysis of its long-term efficacy,&#8221;</em>&#160;<strong>commented Pierre Dodion, MD, Executive Vice President and Chief Medical Officer of Innate Pharma.&#160;</strong><em>&#8220;We are grateful to the patients and health care professionals who participated in the clinical development of Lumoxiti and we are passionate about continuing to address&#160;the&#160;unmet need in this rare form of cancer.&#8221;&#160;</em></p>  <p align="justify">The single-arm, multi-center, open-label Phase III &#8216;1053&#8217; clinical trial assessed the efficacy, safety, immunogenicity and pharmacokinetics of Lumoxiti monotherapy in 80 patients with relapsed or refractory hairy cell leukemia who had received at least two prior therapies, including one purine nucleoside analog. The primary endpoint of durable CR was defined as CR with hematologic remission (HR) for &gt;180 days.&#160;</p>  <p align="justify">Findings from the final analysis of the Lumoxiti Phase III trial include:</p> <table style="width:100%; border-collapse:collapse !important;;border-collapse: collapse; "><tr><td style="border-top: solid black 1pt ; border-right: solid black 1pt ; border-bottom: solid black 1pt ; border-left: solid black 1pt ; text-align: justify ;  vertical-align: middle; vertical-align: top ; "><strong>Efficacy measure</strong></td><td style="border-top: solid black 1pt ; border-right: solid black 1pt ; border-bottom: solid black 1pt ; text-align: justify ;  vertical-align: middle; vertical-align: top ; "><strong>Result* (n=80, 95% Confidence Interval)</strong></td></tr><tr><td style="border-right: solid black 1pt ; border-bottom: solid black 1pt ; border-left: solid black 1pt ; text-align: justify ;  vertical-align: middle; vertical-align: top ; ">Durable CR (CR with HR &gt; 180 days)</td><td style="border-right: solid black 1pt ; border-bottom: solid black 1pt ; text-align: justify ;  vertical-align: middle; vertical-align: top ; ">36.3% (25.8 to 47.8)</td></tr><tr><td style="border-right: solid black 1pt ; border-bottom: solid black 1pt ; border-left: solid black 1pt ; text-align: justify ;  vertical-align: middle; vertical-align: top ; ">CR with HR &#8805; 360 days</td><td style="border-right: solid black 1pt ; border-bottom: solid black 1pt ; text-align: justify ;  vertical-align: middle; vertical-align: top ; ">32.5% (22.4 to 43.9)</td></tr><tr><td style="border-right: solid black 1pt ; border-bottom: solid black 1pt ; border-left: solid black 1pt ; text-align: justify ;  vertical-align: middle; vertical-align: top ; ">CR rate</td><td style="border-right: solid black 1pt ; border-bottom: solid black 1pt ; text-align: justify ;  vertical-align: middle; vertical-align: top ; ">41.3% (30.4 to 52.8)</td></tr><tr><td style="border-right: solid black 1pt ; border-bottom: solid black 1pt ; border-left: solid black 1pt ; text-align: justify ;  vertical-align: middle; vertical-align: top ; ">CR with MRD-negative status</td><td style="border-right: solid black 1pt ; border-bottom: solid black 1pt ; text-align: justify ;  vertical-align: middle; vertical-align: top ; ">33.8% (23.6 to 45.2)</td></tr><tr><td style="border-right: solid black 1pt ; border-bottom: solid black 1pt ; border-left: solid black 1pt ; text-align: justify ;  vertical-align: middle; vertical-align: top ; ">Partial Response Rate</td><td style="border-right: solid black 1pt ; border-bottom: solid black 1pt ; text-align: justify ;  vertical-align: middle; vertical-align: top ; ">33.8%</td></tr><tr><td style="border-right: solid black 1pt ; border-bottom: solid black 1pt ; border-left: solid black 1pt ; text-align: justify ;  vertical-align: middle; vertical-align: top ; ">Hematologic Remission Rate</td><td style="border-right: solid black 1pt ; border-bottom: solid black 1pt ; text-align: justify ;  vertical-align: middle; vertical-align: top ; ">80.0%</td></tr><tr><td style="border-right: solid black 1pt ; border-bottom: solid black 1pt ; border-left: solid black 1pt ; text-align: justify ;  vertical-align: middle; vertical-align: top ; ">Median duration of CR</td><td style="border-right: solid black 1pt ; border-bottom: solid black 1pt ; text-align: justify ;  vertical-align: middle; vertical-align: top ; ">62.8 months (0.0+ to 62.8)</td></tr><tr><td style="border-right: solid black 1pt ; border-bottom: solid black 1pt ; border-left: solid black 1pt ; text-align: justify ;  vertical-align: middle; vertical-align: top ; ">Median Progression-Free Survival&#160;</td><td style="border-right: solid black 1pt ; border-bottom: solid black 1pt ; text-align: justify ;  vertical-align: middle; vertical-align: top ; ">41.5 months (range 0.0+ to 71.7)</td></tr></table> <p align="justify">* BICR = blinded independent central review</p>  <p align="justify"><em>&#8220;A key treatment goal for patients with relapsed or refractory hairy cell leukemia is to achieve sustained remission, which can be particularly challenging in patients in whom prior therapies have failed. This long-term analysis demonstrates that Lumoxiti achieved a high rate of durable efficacy, while maintaining the benefit risk profile we saw in the primary analysis,&#8221;</em> <strong>said Robert J. Kreitman, MD, Senior Investigator, Head of Clinical Immunotherapy Section, Laboratory of Molecular Biology, Center for Cancer Research, National Cancer Institute, and Principal Investigator of the Phase III clinical trial.&#160;</strong></p>  <p align="justify">The final analysis shows that the risk-benefit profile of Lumoxiti is maintained. There were no new serious adverse events and no change in hemolytic uremic syndrome or capillary leak syndrome. Per the primary analysis on the 1053 study, the most frequent treatment-related adverse events (AEs) were peripheral edema (39%), nausea (35%), fatigue (34%), headache (33%), and pyrexia (31%). Treatment-related grade 3/4 AEs were reported in 24 patients (30%) and treatment-related serious AEs in 14 patients (18%). Grade 3/4 CLS events occurred in two patients (2.5%) and any grade of HUS occurred in six patients (7.5%). CLS and HUS events were manageable and reversible with appropriate supportive care and monitoring.</p>  <p align="justify">Treatment-emergent AEs led to study drug discontinuation in eight patients (10.0%): hemolytic uremic syndrome (HUS), n = 4 (5.0%); capillary leak syndrome (CLS), n = 2 (2.5%); increased blood creatinine, n = 2 (2.5%); renal failure, n =1 (1.3%); vomiting, n =1 (1.3%); and chills, n =1 (1.3%). There were four deaths reported (including the three reported during the primary analysis): two due to disease progression and two due to an AE (1 each of pneumonia and septic shock). No death was considered treatment related.&#160;</p>  <p align="justify"><strong>About Lumoxiti (moxetumomab pasudotox-tdfk):</strong></p>  <p align="justify">Lumoxiti&#160;is a CD22-directed immunotoxin and a first-in-class treatment in the US for adult patients with relapsed or refractory (r/r) hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog. Lumoxiti&#160;is not recommended in patients with severe renal impairment (CrCl &#8804; 29 mL/min).&#160; It comprises the CD22 binding portion of an antibody fused to a truncated pseudomonas exotoxin. The toxin inhibits protein synthesis and ultimately triggers apoptotic cell death.&#160;Lumoxiti&#160;received U.S. FDA approval in September 2018 and has been granted Orphan Drug Designation by the FDA and the European Medicines Agency for the treatment of r/r HCL. AstraZeneca is the current Biologics License Application (BLA) holder for Lumoxiti.</p>  <p align="justify"><strong>About the &#8216;1053&#8217; Phase III trial:</strong></p>  <p align="justify">The approval of Lumoxiti was based on data from the AstraZeneca-sponsored, open-label &#8216;1053&#8217; trial, which was a single-arm, multi-center Phase III clinical trial assessing the efficacy, safety, immunogenicity and pharmacokinetics of Lumoxiti monotherapy in patients with r/r HCL who have received at least two prior therapies, including one purine nucleoside analog. The trial enrolled 80 patients and was conducted across 34 sites in 14 countries.&#160;The primary endpoint was durable complete response (CR), defined as CR with hematologic remission (blood count normalization) for more than 180 days. Secondary endpoints included overall response rate, relapse-free survival, progression-free survival, time to response, safety, pharmacokinetics and immunogenic potential.</p>  <p align="justify"><strong>About Innate Pharma:</strong></p>  <p align="justify">Innate Pharma S.A. is a commercial stage oncology-focused biotech company dedicated to improving treatment and clinical outcomes for patients through therapeutic antibodies that harness the immune system to fight cancer.</p>  <p align="justify">Innate Pharma&#8217;s commercial-stage product, Lumoxiti, in-licensed from AstraZeneca in the US, EU and Switzerland, was approved by the FDA in September 2018. Lumoxiti is a first-in class specialty oncology product for hairy cell leukemia. Innate Pharma&#8217;s broad pipeline of antibodies includes several potentially first-in-class clinical and preclinical candidates in cancers with high unmet medical need.</p>  <p align="justify">Innate has been a pioneer in the understanding of natural killer cell biology and has expanded its expertise in the tumor microenvironment and tumor-antigens, as well as antibody engineering. This innovative approach has resulted in a diversified proprietary portfolio and major alliances with leaders in the biopharmaceutical industry including Bristol-Myers Squibb, Novo Nordisk A/S, Sanofi, and a multi-products collaboration with AstraZeneca.</p>  <p align="justify">Based in Marseille, France, Innate Pharma is listed on Euronext Paris and Nasdaq in the US.</p>  <p align="justify">Learn more about Innate Pharma at <u>www.innate-pharma.com </u></p>  <p align="justify"><strong>Information about Innate Pharma shares:</strong></p> <table style="width:100%; border-collapse:collapse !important;;border-collapse: collapse; "><tr><td style="text-align: left ;  vertical-align: middle; vertical-align: top ; "><strong>ISIN code</strong><br ><strong>Ticker code</strong><br ><strong>LEI</strong></td><td style="text-align: left ;  vertical-align: middle; vertical-align: top ; ">FR0010331421<br >Euronext: IPH Nasdaq: IPHA<br >9695002Y8420ZB8HJE29</td></tr></table> <p align="justify"><strong>Disclaimer:</strong></p>  <p align="justify">This press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995.The use of certain words, including &#8220;believe,&#8221; &#8220;potential,&#8221; &#8220;expect&#8221; and &#8220;will&#8221; and similar expressions, is intended to identify forward-looking statements.&#160;Although the company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company&#8217;s commercialization efforts and the Company&#8217;s continued ability to raise capital to fund its development.&#160;For an additional discussion of risks and uncertainties which could cause the company's actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (&#8220;Facteurs de Risque") section of the Universal Registration Document filed with the French Financial Markets Authority (&#8220;AMF&#8221;), which is available on the AMF website http://www.amf-france.org or on Innate Pharma&#8217;s website, and public filings and reports filed with the U.S. Securities and Exchange Commission (&#8220;SEC&#8221;), including the Company&#8217;s final prospectus dated October 16, 2019, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public, by the Company.</p>  <p align="justify">This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.</p>  <p align="justify"><strong>For additional information, please contact:</strong></p> <table style="width:100%; border-collapse:collapse !important;;border-collapse: collapse; "><tr><td style="text-align: justify ;  vertical-align: middle; vertical-align: top ; "><strong><u>Investors</u></strong><br ><br ><strong>Innate Pharma&#160; </strong><br >Danielle Spangler / J&#233;r&#244;me Marino<br >Tel.: +33 (0)4 30 30 30 30<br ><u>investors@innate-pharma.com</u><br ><br > <strong>&#160;</strong></td><td style="text-align: justify ;  vertical-align: middle; vertical-align: top ; "><strong><u>Media</u></strong><br ><br ><strong>Innate Pharma&#160; </strong><br >Tracy Rossin (Global/US)<br >Tel.: +1 240 801 0076<br ><u>Tracy.Rossin@innate-pharma.com</u><br ><strong>&#160;</strong><br > <strong>ATCG Press </strong><br >Marie Puvieux (France)<br >Tel.: +33 (0)9 81 87 46 72<br ><u>innate-pharma@atcg-partners.com</u></td></tr></table> <p>&#160;<br ></p> </p><p ></p></body></html>
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