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
For the month of November 2024
Commission File Number: 001-37384
GALAPAGOS NV
(Translation of registrant's name into English)
Generaal De Wittelaan L11 A3 2800 Mechelen, Belgium
(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 [ ]
The information contained in this Report on Form 6-K, including Exhibit 99.1, except for the quote of Jeevan Shetty, MD, included in Exhibit 99.1, is hereby incorporated by reference into the Company's Registration Statements on Form S-8 (File Nos. 333-204567, 333-208697, 333-211834, 333-215783, 333- 218160, 333-225263, 333-231765, 333-249416, 333-260500, 333-268756, and 333-275886).
On November 5, 2024, the Registrant issued a press release, a copy of which is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
(c) Exhibit 99.1. Press release dated November 5, 2024
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.
GALAPAGOS NV | ||
(Registrant) | ||
Date: November 6, 2024 | /s/ Annelies Denecker | |
Annelies Denecker | ||
Company Secretary | ||
EXHIBIT 99.1
Galapagos to Present Results of Pioneering Innovation in Cancer Cell Therapy at ASH 2024
Mechelen, Belgium; November 5, 2024, 22:01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) today announced that it will present new data from its CAR T- and TCR T-cell therapy pipeline at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, CA, 7-10 December 2024.
Three abstracts, including one oral presentation, will feature new data from our proprietary cell therapy programs in relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL), and R/R chronic lymphocytic leukemia (CLL) and Richter transformation (RT), in addition to preclinical data in head & neck (H&N) cancer, developed in partnership with Adaptimmune. Galapagos will also host a company showcase, titled: Fresh, Fit, and Fast: Pioneering the Future of Cell Therapy through Decentralized Manufacturing.
“We are committed to advancing breakthrough innovations to expand the reach of cell therapies for patients with rapidly progressing cancers,” said Jeevan Shetty, MD, Head of Clinical Development Oncology at Galapagos. “We are excited to present promising new clinical data for our CD19 CAR T-cell therapy candidates, which continue to support the hypothesis that delivering fresh, fit cells quickly could improve outcomes for patients. Additionally, the preclinical proof-of-concept data we will present with our partner Adaptimmune highlight the potential of our innovative approach in treating solid tumors, expanding our reach to critically-ill patients beyond hematological cancers.”
The data to be presented are summarized below:
The dates and times for accepted abstracts, presentations and our company showcase are as follows:
Abstract title | Authors (Presenter) | Presentation date/time |
Galapagos-driven original abstracts | ||
ATALANTA-1: A Phase 1/2 Trial of GLPG5101, a Fresh, Stem-Like, Early Memory CD19 CAR T-Cell Therapy with a 7-Day Vein-to-Vein Time, for the Treatment of Relapsed/Refractory Non-Hodgkin Lymphoma | Marie José Kersten, Kirsten
Saevels, Evelyne Willems, Marte C. Liefaard, Stavros Milatos, Margot J. Pont, Claire Vennin, Eva Santermans, Anna D.D. Van Muyden, Jeevan
Shetty, Esmée P. Hoefsmit, Omotayo Fasan, Maria T. Kuipers, Sébastien Anguille, Joost S.P. Vermaat |
Oral presentation
number: 93 Date: Saturday, December 7, 2024 Time: 10:00 PT (session 09:30-11:00 PT) Session: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: CAR-T Cell Therapies for Lymphomas and ALL: New Strategies and Toxicities Location: Marriott Marquis San Diego Marina, Marriott Grand Ballroom 11-13 |
EUPLAGIA-1: A Phase 1/2 Trial of GLPG5201, a Fresh Stem-Like Early Memory CD19 CAR T-Cell Therapy with a 7-Day Vein-to-Vein Time, in Patients
with Relapsed/Refractory CLL and RT |
Valentin Ortiz-Maldonado, Nuria Martínez-Cibrián, Leticia Alserawan, Sergi Betriu, Ana Triguero, Sandra Blum, Margaux Faes, Marte C. Liefaard, Margot J. Pont, Maike Spoon, Kirsten Van Hoorde, Anna D. D. van Muyden, Julio Delgado, Natalia Tovar | Poster presentation
number: 3452 Date: Sunday, December 8, 2024 Time: 18:00-20:00 PT Session: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster II Location: San Diego Convention Center, Halls G-H |
Galapagos company showcase | ||
Fresh, Fit, and Fast: Pioneering the Future of Cell Therapy through Decentralized Manufacturing | Dr. Jeevan Shetty, M.D., Head of Clinical Development Oncology, Galapagos, Ms. Jacqueline Vink-Korndorffer, Head of Global Cell Therapy Operations, Galapagos | Date: Saturday,
December 7, 2024 Time: 13:45-14:00 PT Location: Room 3, Upper Level, San Diego Convention Center |
Adaptimmune-driven abstracts | ||
Preclinical Proof of Concept for Decentralized Manufacturing of a MAGE-A4/CD8α–Expressing Autologous T-Cell Therapy for Solid Tumors |
Melissa Herman, Stefania Gobessi, Laurens Sand, Karolin Wagner, Ryan Yuan, Sterenn Davis, Ian Donaldson, Megan Butler, Natalie Bath, Robert Harris, Nathaniel Golden, Alex Tipping, Joseph Sanderson, John Mellors, Phillip Debnam | Poster presentation
number: 2100 Date: Saturday, December 7, 2024 Time: 17:30-19:30 PT Session: 711. Cell Collection and Manufacturing of HSPCs, CAR-T Cells, and Other Cellular Therapy Products: Poster I Location: San Diego Convention Center, Halls G-H |
About Galapagos’ cell therapy manufacturing platform
Galapagos’ innovative decentralized
cell therapy manufacturing platform has the potential for the administration of fresh, fit cells within a median vein-to-vein time of
seven days, greater physician visibility, and improved patient experience. The platform consists of an end-to-end xCellit® workflow
management and monitoring software system, a decentralized, functionally closed, automated manufacturing platform for cell therapies (using
Lonza’s Cocoon®) and a proprietary quality control testing and release strategy.
About Galapagos
We are a biotechnology company with operations in Europe and the U.S. dedicated
to transforming patient outcomes through life-changing science and innovation for more years of life and quality of life. Focusing on
high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class
small molecules and cell therapies in oncology and immunology. With capabilities from lab to patient, including a decentralized cell therapy
manufacturing platform, and the financial strength to invest strategically for the near- and long-term, we are committed to challenging
the status quo and delivering results for our patients, employees, and shareholders. Our goal is not just to meet current medical needs
but to anticipate and shape the future of healthcare, ensuring that our innovations reach those who need them most. For additional information,
please visit www.glpg.com or follow us on LinkedIn or X.
For further information, please contact:
Media inquiries: Srikant Ramaswami +1 412 699 0359 Marieke Vermeersch +32 479 490 603 Jennifer Wilson + 44 7539 359 676 media@glpg.com |
Investor inquiries: Sofie Van Gijsel +1 781 296 1143 Sandra Cauwenberghs +32 495 58 46 63 ir@glpg.com |
Forward-looking statements
This press release includes forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These statements are often, but are not always, made
through the use of words or phrases such as “anticipate,” “expect,” “plan,” “estimate,”
“will,” “continue,” “aim,” “intend,” “future,” “potential,” “could,”
“indicate,” “forward,” “may,” as well as similar expressions. Forward-looking statements contained
in this press release include, but are not limited to, statements regarding preliminary, interim and topline data from the ATALANTA-1
and EUPLAGIA-1 studies and other analyses related to Galapagos’ CD19 CAR-T programs, statements related to Galapagos’ plans,
expectations and strategy with respect to the ATALANTA-1 and EUPLAGIA-1 studies, and statements regarding the expected timing, design
and readouts of the ATALANTA-1 and EUPLAGIA-1 studies, including the expected recruitment for such trials, and the potential benefits
of Galapagos’ product candidates, including GLPG5101, GLPG5201, and partnered programs, including uza-cel. Forward-looking statements
involve known and unknown risks, uncertainties and other factors which might cause Galapagos’ actual results to be materially different
from those expressed or implied by such forward-looking statements. These risks, uncertainties and other factors include, without limitation,
the risk that preliminary or interim clinical results may not be replicated in ongoing or subsequent clinical trials, the risk that ongoing
and future clinical studies with Galapagos’ product candidates, including GLPG5101 and GLPG5201, may not be completed in the currently
envisaged timelines or at all, the inherent uncertainties associated with competitive developments, clinical trial and product development
activities and regulatory approval requirements (including that data from the ongoing and planned clinical research programs may not support
registration or further development of GLPG5101 and GLPG5201 due to safety, efficacy or other reasons), Galapagos' reliance on collaborations
with third parties (including its collaboration partners Lonza and Adaptimmune), and that Galapagos’ estimations regarding its GLPG5101
and GLPG5201 development programs and regarding the commercial potential of GLPG5101 and GLPG5201 may be incorrect, as well as those risks
and uncertainties identified in Galapagos’ Annual Report on Form 20-F for the year ended 31 December 2023 filed with the U.S. Securities
and Exchange Commission (SEC) and its subsequent filings with the SEC. All statements other than statements of historical fact are statements
that could be deemed forward-looking statements. The forward-looking statements contained herein are based on management’s current
expectations and beliefs and speak only as of the date hereof, and Galapagos makes no commitment to update or publicly release any revisions
to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations.