NovoCure Limited filed SEC Form 8-K: Regulation FD Disclosure, Financial Statements and Exhibits
$NVCR
Medical/Dental Instruments
Health Care
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
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Item 7.01 Regulation FD Disclosure
On May 31, 2025, NovoCure Limited (the "Company" or "Novocure"), issued a press release announcing that on that day it presented positive results from the phase 3 PANOVA-3 clinical trial ("PANOVA-3") evaluating the use of Tumor Treating Fields (TTFields) therapy with gemcitabine and nab-paclitaxel (GnP) for locally advanced pancreatic adenocarcinoma (LA-PAC) at the 2025 American Society of Clinical Oncology Annual Meeting ("ASCO 2025") and that the results will be simultaneously published in the Journal of Clinical Oncology. The press release is attached hereto as Exhibit 99.1 and incorporated by reference herein. The data provided at the presentation is attached hereto as Exhibit 99.2 and incorporated by reference herein. This data is available on the Company's investor relations page at www.novocure.com.
Also on May 31, 2025, the Company hosted an investor event that included a presentation and discussion of the results from PANOVA-3 that were presented at ASCO 2025. The data provided at the investor event is attached hereto as Exhibit 99.3 and incorporated by reference herein. This data is also available on the Company's investor relations page at www.novocure.com.
The PANOVA-3 data are expected to serve as the basis for a Premarket Approval (PMA) submission to the U.S. Food and Drug Administration in the second half of 2025.
The information contained in this Item 7.01 of this Current Report shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
| Exhibit No. | Description | ||||
| 99.1 | |||||
| 99.2 | |||||
| 99.3 | |||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | ||||
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 hereunto duly authorized.
NovoCure Limited
(Registrant)
Date: June 2, 2025
By: /s/ Christoph Brackmann
Name: Christoph Brackmann
Title: Chief Financial Officer