Innate Pharma: Clarification Regarding SAR443579 Designation

Rhea-AI Summary

Innate Pharma, listed on Euronext Paris (IPH) and Nasdaq (IPHA), clarified that their molecule SAR443579/IPH6101 was incorrectly mentioned as having breakthrough designation in an abstract published for the European Hematology Association 2024 Congress. The correct status is that the molecule has received US FDA Fast Track Designation, as communicated in June 2023. This clarification aims to rectify the misinformation released on May 14, 2024, by Sanofi.

Positive

• SAR443579/IPH6101 has received US FDA Fast Track Designation, which can expedite the review process and potentially bring the treatment to market faster.
• The clarification helps maintain transparency and investor trust by correcting the misinformation.

Negative

• The incorrect mention of breakthrough designation could cause confusion among investors and stakeholders.
• Misinformation may affect investor sentiment and potentially lead to short-term stock volatility.

MARSEILLE, France--(BUSINESS WIRE)-- Regulatory News:

Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that in an abstract published on 14 May 2024 for the European Hematology Association 2024 Congress on SAR443579/IPH6101, submitted by Sanofi, it was mentioned that the molecule received breakthrough designation. This is an error. The molecule has US FDA Fast Track Designation, as communicated before in June 2023.

About ANKET^®

ANKET^® (Antibody-based NK cell Engager Therapeutics) is Innate's proprietary platform for developing next-generation, multi-specific natural killer (NK) cell engagers to treat certain types of cancer. This versatile, fit-for-purpose technology is creating an entirely new class of molecules to induce synthetic immunity against cancer.

About the Innate-Sanofi research collaboration and licensing agreements

The Company has a research collaboration and license agreement with Sanofi to apply Innate’s proprietary technology to the development of innovative multi-specific antibody formats engaging NK cells through the activating receptors NKp46 and CD16 to kill tumor cells.

Under the terms of the 2016 research collaboration and license agreement, Sanofi is responsible for the development, manufacturing and commercialization of products resulting from the research collaboration, which includes SAR443579/IPH6101 (Trifunctional anti-CD123 NKp46xCD16 NK cell engager) and SAR445514/IPH6401 (Trifunctional anti-BCMA NKp46xCD16 NK cell engager). As part of the 2016 agreement, Innate Pharma is eligible to up to €400m in development and commercial milestone payments as well as royalties on net sales.

As part of the license agreement entered in December 2022, Sanofi licensed IPH62 and IPH67 and has the option for one additional target. Under the terms of the 2022 agreement, Innate Pharma is eligible to up to €1.35bn in development and commercial milestone payments as well as royalties on net sales.

About Innate Pharma

Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Its innovative approach aims to harness the innate immune system through therapeutic antibodies and its ANKET^® (Antibody-based NK cell Engager Therapeutics) proprietary platform.

Innate’s portfolio includes lead proprietary program lacutamab, developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, monalizumab developed with AstraZeneca in non-small cell lung cancer, as well as ANKET^® multi-specific NK cell engagers to address multiple tumor types.

Innate Pharma is a trusted partner to biopharmaceutical companies such as Sanofi and AstraZeneca, as well as leading research institutions, to accelerate innovation, research and development for the benefit of patients.

Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US.

Learn more about Innate Pharma at www.innate-pharma.com and follow us on LinkedIn and X.

Information about Innate Pharma shares

ISIN code		FR0010331421
Ticker code		Euronext: IPH Nasdaq: IPHA
LEI		9695002Y8420ZB8HJE29

Disclaimer on forward-looking information and risk factors

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 “believe,” “potential,” “expect” and “will” and similar expressions, is intended to identify forward-looking statements. 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’s commercialization efforts and the Company’s continued ability to raise capital to fund its development. 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 (“Facteurs de Risque") section of the Universal Registration Document filed with the French Financial Markets Authority (“AMF”), which is available on the AMF website http://www.amf-france.org or on Innate Pharma’s website, and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 20-F for the year ended December 31, 2023, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public, by the Company.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240520624001/en/

Investors

Innate Pharma

Henry Wheeler

Tel.: +33 (0)4 84 90 32 88

Henry.wheeler@innate-pharma.fr

Media Relations

NewCap

Arthur Rouillé

Tel.: +33 (0)1 44 71 00 15

innate@newcap.eu

Source: Innate Pharma SA

FAQ

What is the correct designation for SAR443579/IPH6101 as of May 2024?

SAR443579/IPH6101 has received US FDA Fast Track Designation, not breakthrough designation.

When was the Fast Track Designation for SAR443579/IPH6101 communicated?

The Fast Track Designation was communicated in June 2023.

Which company published the incorrect information about SAR443579/IPH6101?

The incorrect information was published by Sanofi.

What event was the abstract concerning SAR443579/IPH6101 published for?

The abstract was published for the European Hematology Association 2024 Congress.

How might the incorrect mention of breakthrough designation affect IPHA stock?

The misinformation could cause confusion and short-term stock volatility.