UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
December 20, 2023
Commission File Number: 001-39084
Innate Pharma S.A.
(Translation of registrant's name into English)
Innate Pharma S.A.
117 Avenue de Luminy—BP 30191
13009 Marseille, France
+ 33 (0) 4 30 30 30
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F [ X ] Form 40-F [ ]
INCORPORATION BY REFERENCE
This Report on Form 6-K shall be deemed to be incorporated by reference in the registration statement on Form F-3 of Innate Pharma S.A. (the “Company” or “Innate Pharma”) filed with the Securities and Exchange Commission on the date hereof and to be part thereof from the date on which this Report is furnished, to the extent not superseded by documents or reports subsequently filed or furnished by the Company.
CAUTIONARY STATEMENT ABOUT FORWARD-LOOKING STATEMENTS
This Report on Form 6-K including its exhibits contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are based on the management’s beliefs and assumptions and on information currently available to the management. All statements other than present and historical facts and conditions contained in this Report on Form 6-K including its exhibits, including statements regarding the future results of operations and financial position, business strategy, plans and the Company's objectives for future operations, are forward-looking statements. When used in this Report on Form 6-K including its exhibits, the words “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “intend,” “continues,” “target,” “is designed to,” “may,” “might,” “plan,” “potential,” “predict,” “objective,” “should,” or the negative of these and similar expressions identify forward-looking statements. Forward-looking statements include, but are not limited to, statements about:
•the prospects of attaining, maintaining and expanding marketing authorization for monalizumab, lacutamab and other product candidates;
•the initiation, timing, progress and results of the Company’s preclinical studies and clinical trials and those conducted by third parties, including the Company’s collaborators, AstraZeneca and Sanofi;
•the Company’s ability to successfully develop and advance its pipeline of product candidates;
•the timing or likelihood of regulatory filings and approvals;
•the Company’s ability to contract with third-party suppliers and manufacturers and their ability to perform adequately;
•future agreements with third parties in connection with the late-stage development and commercialization of the Company’s product candidates and any other approved product;
•the Company’s ability to develop sales and marketing capabilities and transition into a commercial-stage company;
•the pricing and reimbursement of the Company's product candidates, if approved;
•the effects of increased competition as well as innovations by new and existing competitors in the Company’s industry;
•the Company’s ability to obtain funding for its operations;
•the Company’s ability to obtain, maintain, protect and enforce its intellectual property rights and propriety technologies and to operate its business without infringing the intellectual property rights and proprietary technology of third parties;
•regulatory developments in the United States, Europe and other countries;
•costs of compliance and failure to comply with new and existing governmental regulations including, but not limited to, tax regulations;
•statements regarding future revenue, hiring plans, expenses, capital expenditures, capital requirements and stock performance;
•the impact of the current state of the world financial market and economic conditions as well as recent health and geopolitical events; and
•other risks and uncertainties, including those listed in the section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2022 (the “Annual Report”) titled “Item 3.D – Risk Factors.”
You should refer to the section of the Annual Report titled “Item 3.D – Risk Factors” for a discussion of important factors that may cause actual results to differ materially from those expressed or implied by the forward-looking statements. As a result of these factors, the Company cannot assure you that the forward-looking statements in this Report on Form 6-K will prove to be accurate. Furthermore, if the forward-looking
statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by the Company or any other person that the Company will achieve its objectives and plans in any specified time frame or at all. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
In addition, statements that “Innate believes” and similar statements reflect its beliefs and opinions on the relevant subject. These statements are based upon information available to the Company as of the date of this Report on Form 6-K, and while the Company believes such information forms a reasonable basis for such statements, such information may be limited or incomplete, and the statements should not be read to indicate that the Company has conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements.
This Report on Form 6-K and its exhibits contain summaries of certain provisions contained in documents described herein or therein, but reference is made to the actual documents for complete information. All of the summaries are qualified in their entirety by the actual documents.
You should read this Report on Form 6-K including its exhibits and the documents that the Company references in this A Report on Form 6-K completely and with the understanding that the Company’s actual future results, levels of activity, performance and events and circumstances may be materially different from what the Company expects. The Company qualifies all of its forward-looking statements by these cautionary statements.
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| EXHIBIT INDEX |
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| Exhibit | Description |
| 99.1 | |
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SIGNATURES
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.
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| INNATE PHARMA S.A. |
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Date: December 20, 2023 | By: /s/ Mondher Mahjoubi |
| Name: Mondher Mahjoubi |
| Title: Chairman of the Executive Board and Chief Executive Officer |
Recent Developments Since June 30, 2023
On September 22, 2023, Innate Pharma announced interim efficacy results from the TELLOMAK Phase 2 study in advanced mycosis fungoides according to updated guidelines at the EORTC Cutaneous Lymphoma Tumour Group Annual Meeting 2023, that was held September 21-23, 2023 in Leiden, the Netherlands. The data provided clinical activity and favorable safety profile of lacutamab, an anti-KIR3DL2 antibody. The data were previously presented at the 17th International Conference on Malignant Lymphoma, in Lugano, Switzerland, in June 2023.
On November 14, 2023, Innate Pharma announced its revenues for the first nine months of 2023 and its cash position as of September 30, 2023. Cash, cash equivalents, short-term investments and financial assets of the Company and its consolidated subsidiaries amounted to €121.9 million as of September 30, 2023. At the same date, financial liabilities amounted to €40.3 million. Revenues for the first nine months of 2023 amounted to €36.5 million (€44.3 million for the same period in 2022). For the nine-month period ended September 30, 2023, revenue from collaboration and licensing agreements mainly results from the partial or entire recognition of the proceeds received pursuant to the agreements with AstraZeneca, Sanofi and Takeda.
In addition, Innate Pharma announced that Dr. Sonia Quaratino, MD, PhD, had been appointed as Executive Vice President and Chief Medical Officer of Innate Pharma, effective October 2023. Dr. Quaratino brings over 25 years of experience in basic research, clinical development, and translational medicine, having worked in academia, global large pharmaceuticals, and biotechs. Recently, Dr. Quaratino was Chief Medical Officer at Georgiamune INC.(USA) and prior to that she was Chief Medical Officer at Kymab (UK), a clinical-stage biopharmaceutical company with a focus on immune-mediated diseases and immuno-oncology, acquired by Sanofi in 2021. Previously, she held roles at Novartis (Switzerland) and Merck Serono (Germany) and was Professor of Immunology in UK at the University of Southampton. Her research has been published in high impact scientific journals.
Innate Pharma also provided an update on pipeline highlights, including:
•In October 2023, the U.S. Food and Drug Administration (“FDA”) placed a partial clinical hold on the lacutamab IND leading to a pause in new patient enrollment to the Company’s ongoing lacutamab trials IPH4102-201 (Phase 2 TELLOMAK) and 102 (Phase 1b PTCL). The partial clinical hold follows one fatal case of hemophagocytic lymphohistiocytosis, a rare hematologic disorder. Patients already on study treatment who are deriving clinical benefit may continue treatment after being reconsented. The Company is currently undertaking efforts to address the FDA requests, which include incorporation of risk mitigation and management strategies for hemophagocytic lymphohistiocytosis in ongoing lacutamab studies.
•TELLOMAK, the ongoing Phase 2 trial of lacutamab in cutaneous T-cell lymphoma, completed enrollment in Q2 2023 (n=170 patients). On December 10, 2023, the Company announced that it presented final results from the Phase 2 TELLOMAK study in Sézary Syndrome at the American Society of Hematology (“ASH”) Annual Meeting in December 2023. As of May 1, 2023, the study’s data cutoff, patients in the Sézary Syndrome cohort (cohort 1, n=56) received a median of five prior systemic therapies, including mogamulizumab, and had a median follow-up of 14.4 months. The data demonstrated that lacutamab showed robust clinical activity and an overall favorable safety profile. The global confirmed objective response rate (“ORR”) was 37.5% (21 out of 56), including two complete responses and 19 partial responses. ORR in the skin was 46.4% (26 out of 56), including five complete responses and 21 partial responses and ORR in the blood was 48.2% (27 out of 56) with 15 CR and 12 PR. Median progression-free survival was 8.0 months (95% confidence interval 4.7-21.2). In patients who achieved a global response, the median duration of response is 12.3 months (95% confidence interval 5.1-NE). The Company plans to share the results with the regulatory authorities. The Company expects final data from the mycosis fungoides cohort in the second half of 2023.
Efficacy results in Sézary Syndrome patients (n=56)
•Following approval of the FDA Investigational New Drug filing with the FDA in July 2023, IPH6501, Innate’s proprietary tumor antigen, CD20, targeted tetra-specific ANKET® (Antibody-based NK Cell Engager Therapeutics), continues toward a targeted Phase 1 clinical trial in 2023.
•The Company had previously announced that, with respect to the Phase 1/2 clinical trial from a joint research collaboration between the Company and Sanofi, evaluating SAR443579 / IPH6101, a trifunctional anti-CD123 NKp46×CD16 Natural Killer (“NK”) Cell Engager (“NKCE”) and ANKET® platform lead asset, in patients with refractory acute myeloid leukemia (“R/R AML”), B-cell acute lymphoblastic leukemia (“B-ALL”) and high-risk myelodysplasia syndrome (“HR-MDS”):
◦Phase 1/2 dose escalation safety and preliminary efficacy of SAR443579 / IPH6101 in R/R AML, B-ALL and HR-MDS were presented during an oral presentation at the American Society for Clinical Oncology (“ASCO”) 2023 Annual Meeting in June 2023. Preliminary data showed SAR443579 / IPH6101 was well tolerated and induced three complete responses in the eight patients at 1 mg/kg as the highest dose.
◦Preclinical data showing the control of acute myeloid leukemia (“AML”) cells by a trifunctional NKp46-CD16a-NK cell engager targeting CD123 were published in Nature Biotechnology in January 2023.
In addition, on December 11, 2023, the Company announced that the updated efficacy and safety results from an open-label, first-in-human, Phase 1/2 dose-escalation study of SAR443579 / IPH6101, were shared in a poster presentation at the ASH Annual Meeting. Abstract details included:
◦The study, run by Sanofi, tests SAR443579 as a monotherapy for the treatment of blood cancers with high unmet needs, including relapsed or R/R AM), B-ALL and HR-MDS. SAR443579 has U.S. Food and Drug Administration (“FDA”) Fast Track Designation for the treatment of acute myeloid leukemia.
◦As of July 5, 2023, 43 patients (42 R/R AML and one HR-MDS) across eight dose levels at 10 – 6000 μg/kg/dose were included. Patients had received a median of 2.0 (1.0 – 10.0) prior lines of treatment with 13 patients (30.2%) reporting prior hematopoiectic stem cell transplantation and 36 patients (83.7%) with prior exposure to venetoclax. In dose levels with a highest dose of 1000 μg/kg QW, 5 out of 15 (33.3%) AML patients achieved a complete remission (“CR”) (4 CRs and 1 CR with incomplete hematological recovery) as of the cut-off date. Data from preliminary pharmacokinetics / pharmacodynamic and in vitro mechanistic analyses studying dose-response relations were also presented. SAR443579 was well tolerated up to doses of 6000 μg/kg QW with observed clinical benefit in patients with R/R AML. The results are consistent with the predicted favorable safety profile.
On December 18, 2023, Innate Pharma announced that Mondher Mahjoubi resigned from his position as Chief Executive Officer (“CEO”) and Chairman of the Executive Board of the Company (the “Executive Board”), effective as of January 1, 2024, in order to pursue a senior level opportunity at a large pharmaceutical company. Hervé Brailly, Innate Pharma’s current Chairman of the Supervisory Board of the Company (the “Supervisory Board”), former CEO and co-founder, has been appointed as interim CEO and Chairman of the Executive Board while a permanent successor to Mr. Mahjoubi is sought. The Company aims to strengthen its Executive Board in 2024. Irina Staatz-Granzer, who has been Vice-Chairwoman of the Supervisory Board for several years, was appointed Chairwoman of the Supervisory Board, replacing Mr. Brailly in this role.
On December 19, 2023, the Company announced that Sanofi exercised its option to license a NKCE program in solid tumors from Innate’s ANKET® platform, pursuant to the Research Collaboration and Licensing Agreement (the “License Agreement”) between the Company and Genzyme Corporation, a wholly owned subsidiary of Sanofi, previously announced on December 22, 2022. Innate will receive a €15 million payment for the exercise of this option. Under the License Agreement, the Company granted Sanofi an exclusive license to the Company’s B7H3 ANKET® program and options for two additional targets. Once the development candidate is selected, Sanofi is responsible for all development, manufacturing and commercialization. Under the terms of the License Agreement, the Company was eligible for an initial payment of €25 million, which it received in March 2023. Sanofi has now exercised the option for one additional ANKET® program and retains the option for one additional target. Under the terms of the License Agreement, Innate Pharma is eligible to up to €1.35 billion total in preclinical, clinical, regulatory and commercial milestones plus royalties on potential net sales (including all amounts received to date under the License Agreement including the €15 million payment described above).
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