0001645113-23-000036.txt : 20230426 0001645113-23-000036.hdr.sgml : 20230426 20230426100324 ACCESSION NUMBER: 0001645113-23-000036 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 13 CONFORMED PERIOD OF REPORT: 20230426 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20230426 DATE AS OF CHANGE: 20230426 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NovoCure Ltd CENTRAL INDEX KEY: 0001645113 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 000000000 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-37565 FILM NUMBER: 23847200 BUSINESS ADDRESS: STREET 1: NO. 4 THE FORUM STREET 2: GRENVILLE STREET CITY: ST. HELIER STATE: Y9 ZIP: JE2 4UF BUSINESS PHONE: 44 (0)15 3475 6700 MAIL ADDRESS: STREET 1: NO. 4 THE FORUM STREET 2: GRENVILLE STREET CITY: ST. HELIER STATE: Y9 ZIP: JE2 4UF FORMER COMPANY: FORMER CONFORMED NAME: Novocure Ltd DATE OF NAME CHANGE: 20150615 8-K 1 nvcr-20230426.htm 8-K nvcr-20230426
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934

April 26, 2023
Date of Report (date of earliest event reported)

NovoCure Limited
(Exact name of registrant as specified in its charter)
Jersey
001-37565
98-1057807
(State or other jurisdiction of incorporation or organization)
(Commission File Number)
(I.R.S. Employer Identification No.)
No. 4 The Forum, Grenville Street
St. Helier
Jersey
JE2 4UF
(Address of Principal Executive Offices)
(Zip Code)
+44 (0) 15 3475 6700
Registrant's telephone number, including area code

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered
Ordinary Shares, no par valueNVCRThe Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
o



Item 7.01 Regulation FD Disclosure

On April 26, 2023, NovoCure Limited (the "Company" or "Novocure"), issued a press release announcing that the full results of the pivotal LUNAR study in non-small cell lung cancer (NSCLC) will be presented for the first time at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting at 11:09 a.m. CDT on June 6 in Chicago. A copy of the press release is attached as Exhibit 99.1 and incorporated by reference herein.

The information contained in 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
104Cover 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: April 26, 2023


By: /s/ Ashley Cordova
Name: Ashley Cordova
Title: Chief Financial Officer

 EX-99.1 2 ascoannouncementprapril262.htm EX-99.1 Document
Exhibit 99.1
Novocure Announces Presentation of Results of the LUNAR Phase 3 Clinical Trial in Non-Small Cell Lung Cancer at 2023 American Society of Clinical Oncology (ASCO) Annual Meeting

Root, Switzerland – Novocure (NASDAQ: NVCR) today announced the results of the LUNAR phase 3 clinical trial in metastatic, non-small cell lung cancer (NSCLC) will be presented for the first time at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, to be held from June 2 to June 6.
The LUNAR study is a phase 3, open-label, randomized study evaluating the safety and efficacy of Tumor Treating Fields (TTFields) therapy together with standard therapies including immunotherapies for metastatic NSCLC following progression while on or after treatment with platinum-based therapy.
“Novocure is pioneering an innovative therapeutic modality for the treatment of solid tumors targeting the electrical properties of cancer cells,” said William Doyle, Novocure’s Executive Chairman. “LUNAR is the first randomized, phase 3 clinical trial to evaluate the application of TTFields outside of the brain and the first phase 3 clinical trial to evaluate the use of TTFields with immunotherapy. LUNAR enrolled a patient population with metastatic disease that has not seen significant improvement in outcomes since 2016. We are eager to share our groundbreaking data at the 2023 ASCO Annual Meeting and look forward to the opportunity to extend the survival of many more patients with aggressive cancers in the years to come.”
Earlier this year, Novocure announced the LUNAR clinical trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in overall survival when TTFields therapy was added to standard pharmacological therapies compared to standard pharmacological therapies alone.
The LUNAR data will be presented on Tuesday, June 6 at 11:09 a.m. CDT in Hall D1 as a late-breaking abstract during ASCO’s metastatic, non-small cell lung cancer session. The presentation will be given by lead author Ticiana Leal, M.D., of Emory University.
The oral presentation of the LUNAR clinical trial data is one of 10 abstracts on TTFields therapy to be included at the 2023 ASCO Annual Meeting.

ASCO Investor Event
Novocure will host an investor event at 2 p.m. CDT on Tuesday, June 6, 2023. The event will include a presentation and discussion of the LUNAR clinical trial data, featuring leading thoracic oncologists, investigators, and Novocure leadership. A live webcast of the event will be available on the investor relations page of www.novocure.com. For more information or to request in-person attendance, please contact Novocure investor relations (investorinfo@novocure.com).

Industry Expert Theater
On June 3 at 9:30 a.m. CDT, Novocure’s Chief Science Officer Moshe Giladi will discuss future directions for TTFields in the meeting’s Industry Expert Theater.



Abstract Titles
Ten abstract titles from Novocure-sponsored and partner programs include:
•Tumor Treating Fields (TTFields; 150 kHz) with standard of care (SOC) systemic therapy in metastatic non-small cell lung cancer (mNSCLC) following platinum failure: Randomized, phase 3 LUNAR (EF-24) study.
•Real-world experience with Tumor Treating Fields (TTFields) in newly diagnosed glioblastoma: A survival meta-analysis with systematic review
•Post-marketing surveillance safety analysis of patients with CNS malignancies treated with Tumor Treating Fields (TTFields) therapy between 2011–2022
•Phase 3 PANOVA-3 study: Tumor Treating Fields (TTFields) therapy concomitant with gemcitabine and nab-paclitaxel (GnP) for front-line treatment of locally advanced pancreatic cancer
•Phase 3 TRIDENT study (EF-32): Tumor Treating Fields (TTFields; 200 kHz) concomitant with chemoradiation, and maintenance TTFields therapy/temozolomide in newly diagnosed glioblastoma
•Safety and efficacy of Tumor Treating Fields (TTFields) prior and concomitant to radiotherapy in patients with newly diagnosed glioblastoma: Results from PriCoTTF
•The association between body mass index and distribution intensity of Tumor Treating Fields (TTFields) in the lungs (online only)
•Management of Tumor Treating Fields (TTFields) therapy-related skin adverse events in pleural mesothelioma: A single center experience of TTFields therapy concomitant with chemotherapy (online only)
•Tumor Treating Fields (TTFields) therapy skin safety and prevention strategy: Fractionated schema protocol (3-day on/1-day off) improves usage and minimizes skin adverse events (online only)
•Outcomes of stage IV non-small cell lung cancer patients after failure of platinum-based chemotherapy in clinical trials and real-world settings: A literature review (online only)

About Tumor Treating Fields Therapy
Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. The multiple, distinct mechanisms of TTFields therapy work together to selectively target and kill cancer cells. Due to its multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or PARP inhibition in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors. To learn more about Tumor Treating Fields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com.




About Novocure
Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields. Novocure’s commercialized products are approved in certain countries for the treatment of adult patients with glioblastoma, malignant pleural mesothelioma and pleural mesothelioma. Novocure has ongoing or completed clinical studies investigating Tumor Treating Fields in brain metastases, gastric cancer, glioblastoma, liver cancer, non-small cell lung cancer, pancreatic cancer and ovarian cancer.
Headquartered in Root, Switzerland and with a growing global footprint, Novocure has regional operating centers in Portsmouth, New Hampshire and Tokyo, as well as a research center in Haifa, Israel. For additional information about the company, please visit Novocure.com and follow @Novocure on LinkedIn and Twitter.

Forward-Looking Statements
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, clinical study progress, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, environmental, regulatory and political conditions as well as issues arising from the COVID-19 pandemic and other more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 23, 2023, and subsequent flings with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.

Investors:
Ingrid Goldberg
investorinfo@novocure.com
610-723-7427

Media:


Leigh Labrie
media@novocure.com
610-723-7428

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