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Item 1. Business

2026-02-26 compared with 2025-02-27 · 128 added, 138 removed, 368 unchanged (42% of the section changed)

We are a global oncology company with a proprietary platform technology called Tumor Treating Fields ("TTFields"), which are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms.

Our key priorities are to drive commercial adoption of Optune Gio ® and Optune Lua ® , our commercial TTFields therapy devices, and to advance clinical and product development programs intended to extend overall survival in some of the most aggressive forms of cancer.

Our therapy is delivered through a medical device and we continue to advance our Products with the intention to extend survival and maintain quality of life for patients.

We are a global oncology company with a proprietary platform technology called Tumor Treating Fields ("TTFields"), which are electric fields that exert physical forces to kill cancer cells.

Our therapy is delivered through a medical device.

Our key priorities are to drive commercial adoption of Optune Gio ® , Optune Lua ® , and Optune Pax ® , our commercial TTFields therapy devices, obtain regulatory approval to market TTFields therapy devices in new indications, such as brain metastases from non-small cell lung cancer ("NSCLC"), and to advance clinical and product development programs intended to extend overall survival in some of the most aggressive forms of cancer.

Optune Gio is approved by the U.S.

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We also have a CE certificate to market Optune Gio for the treatment of GBM in the European Union ("EU"), as well as approval or local registration in the United Kingdom ("UK"), Japan, Canada and certain other countries.

Optune Lua is approved by the FDA under the PMA pathway for the treatment of adult patients with metastatic non-small cell lung cancer ("NSCLC") concurrent with PD-1/PD-L1 inhibitors or docetaxel following progression on or after a platinum-based regimen.

Optune Lua is also approved under the Humanitarian Device Exemption ("HDE") pathway for the treatment of adult patients with malignant pleural mesothelioma or pleural mesothelioma (together, "MPM") together with standard chemotherapies.

We have also received CE certification in the EU and approval or local registration to market Optune Lua in certain other countries for the treatment of MPM.

We market Optune Gio and Optune Lua in multiple countries around the globe with the majority of our revenues coming from the use of Optune Gio in the U.S., Germany, France and Japan.

We are actively evaluating opportunities to expand our international footprint.

In June 2024, we presented results from the Phase 3 METIS clinical trial evaluating the use of TTFields therapy and best supportive care for the treatment of adult patients with 1-10 brain metastases from NSCLC following stereotactic radiosurgery ("METIS").

The METIS trial met its primary endpoint, demonstrating a statistically significant improvement in time to intracranial progression for patients treated with TTFields therapy and supportive care compared to patients treated with supportive care alone.

In December 2024, we announced the top-line results from the Phase 3 PANOVA-3 clinical trial evaluating the use of TTFields therapy together with gemcitabine and nab-paclitaxel for the treatment of adult patients with unresectable, locally advanced pancreatic cancer ("PANOVA-3").

The PANOVA-3 trial met its primary endpoint, demonstrating a statistically significant improvement in overall survival for patients treated with TTFields therapy, gemcitabine and nab-paclitaxel compared to patients treated with gemcitabine and nab-paclitaxel alone.

We intend to submit marketing applications to regulators in our key markets based on the results of the METIS and PANOVA-3 trials.

We believe the physical mechanisms of action behind TTFields therapy may be broadly applicable to solid tumor cancers.

We have several ongoing clinical trials which further explore the use of TTFields therapy in these solid tumor cancers, including the Phase 3 TRIDENT and KEYNOTE D58 trials in GBM, Phase 3 LUNAR-2 and Phase 2 LUNAR-4 trials in NSCLC, and Phase 2 PANOVA-4 trial in pancreatic cancer.

We anticipate expanding our clinical pipeline over time to study the safety and efficacy of TTFields therapy for additional solid tumor indications and for use together with other cancer treatment modalities.

Optune Lua is approved by the FDA under the PMA pathway for the treatment of adult patients with metastatic NSCLC concurrent with PD-1/PD-L1 inhibitors or docetaxel following progression on or after a platinum-based regimen.

We also have a CE certificate to market Optune Lua concurrent with PD-1/PD-L1 inhibitors or docetaxel following progression on or after a platinum-based regimen for the treatment of metastatic NSCLC in the EU.

In addition, we received regulatory approval for Optune Lua for the treatment of adult patients with unresectable advanced/recurrent NSCLC concurrent with PD-1/PD-L1 inhibitors following progression on or after a platinum-based regimen in Japan.

Optune Lua is also approved by the FDA under the Humanitarian Device Exemption ("HDE") pathway for the treatment of adult patients with malignant pleural mesothelioma or pleural mesothelioma (together, "MPM") together with standard chemotherapies.

We have also have a CE certificate in the EU and approval or local registration to market Optune Lua for the treatment of MPM in certain other countries.

Optune Pax is approved by the FDA under the PMA pathway for the treatment of adult patients with locally advanced pancreatic cancer concurrent with gemcitabine and nab-paclitaxel.

We are pursuing regulatory approval to market Optune Pax in other countries.

We market our Products in multiple countries around the globe with the majority of our revenues coming from the use of Optune Gio in the U.S., Germany, France and Japan.

We are actively evaluating opportunities to expand access to Optune Gio, Optune Lua and Optune Pax in additional international markets.

We have established coverage policies with both public and private payers for the use of Optune Gio in our active markets.

We are actively pursuing coverage policies with payers to expand access to Optune Lua and Optune Pax and in the meantime we will bill and seek reimbursement from payers on an individual case basis, as applicable.

In September 2025, we presented final data from the Phase 3 METIS clinical trial evaluating the use of TTFields therapy and best supportive care (BSC) for the treatment of adult patients (n=298) with 1-10 brain metastases from NSCLC following stereotactic radiosurgery at the 2025 American Society for Radiation Oncology Annual Meeting.

The primary endpoint of the METIS trial was defined as the time to intracranial progression (TTIP), as measured from the date of first SRS treatment to intracranial progression or neurological death, whichever occurred first.

When accounting for competing risks using the Fine–Gray method, patients treated with TTFields therapy and BSC experienced a 28% lower risk of intracranial progression compared to those receiving BSC alone (HR=0.72, p=0.044).

The median time to intracranial progression was 15.0 months in patients treated with TTFields therapy and BSC compared to 7.5 months in patients treated with BSC alone.

In December 2025 we submitted the final module of the PMA, seeking approval under the proposed brand name Optune Mya ® .

The PMA has been accepted as filed by the FDA, and is under substantive review.

We believe the physical mode of action behind TTFields therapy and resulting downstream cellular processes initiated by the damaged cells may be broadly applicable to solid tumor cancers.

We have several ongoing and recently concluded clinical trials which further explore the use of TTFields therapy, including the Phase 3 TRIDENT

and KEYNOTE D58 trials in GBM, Phase 3 LUNAR-2 trial in NSCLC, and Phase 2 PANOVA-4 trial in pancreatic cancer.

We have several product development programs underway that are designed to optimize the delivery of TTFields to the target tumor and enhance patient ease of use.

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Daily management and control of the Company are located in Switzerland, with additional operating centers located around the world.

When cancer develops, rapid and uncontrolled division of unhealthy cells occurs.

When cancer develops, rapid and uncontrolled division of cancerous cells occurs.

Electrically charged proteins within the cell are critical for cell division, making the rapidly dividing cancer cells vulnerable to electrical interference.

TTFields therapy is a treatment that uses electric fields which exert physical forces to kill cancer via a variety of mechanisms.

TTFields therapy uses electric fields to exert physical forces to kill cancer.

All cells are surrounded by a bilipid membrane, which separates the interior of the cell, or cytoplasm, from the space around it.

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TTFields, however, have a unique frequency range, between 100 to 500 kHz, enabling the electric fields to penetrate the cancer cell membrane.

As healthy cells differ from cancer cells in their division rate, geometry and electric properties, the frequency of TTFields can be tuned to specifically affect the cancer cells while leaving healthy cells mostly unaffected.

Whether cells are healthy or cancerous, cell division, or mitosis, is the same.

The frequency of TTFields can be tuned to specifically affect cancer cells while leaving healthy cells mostly unaffected, as healthy cells differ from cancer cells in their division rate, geometry and electric properties.

Whether cells are healthy or cancerous, the process of cell division, or mitosis, is the same.

When mitosis starts, charged proteins within the cell, or microtubules, form the mitotic spindle.

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Interfering with these key processes disrupts mitosis and can lead to cell death.

Our track record of fundamental scientific research extends across more than two decades and, in all of our preclinical research to date, the application of TTFields has demonstrated a consistent anti-mitotic effect.

Preclinical work suggests that the well-established impairment created by the physical effect of TTFields to tumor cells results in a series of changes to cell processes that downregulate DNA damage response, interfere with cell movement and migration, and increase anti-tumor immunity.

Research is ongoing to further refine and build upon our understanding of TTFields' several mechanisms of action.

Our track record of fundamental scientific research extends across more than two decades and, in all of our preclinical research conducted to date, the application of TTFields has demonstrated a consistent anti-mitotic effect.

Preclinical work suggests that the well-established impairment created by the physical effect of TTFields to cancer cells results in a series of changes to cell processes that downregulate DNA damage response, and increase anti-tumor immunity.

Research is ongoing to further refine and build upon our understanding of these downstream mechanisms.

Beyond our internal research efforts, we provide independent researchers with preclinical laboratory bench systems, known as inovitro™ and inovivo™, and we grant funding to support basic and translational research on TTFields therapy.

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TTFields therapy is delivered through a portable medical device.

The complete devices, called Optune Gio and Optune Lua (for head and thoracic treatment, respectively), include a portable electric field generator, arrays, rechargeable batteries and accessories.

Single-use arrays are placed directly on the skin in the region surrounding the tumor and connected to the electric field generator to deliver therapy.

The complete device, called Optune Gio (for the treatment of GBM), Optune Lua (for the treatment of NSCLC and MPM) and Optune Pax (for the treatment of pancreatic cancer), includes a portable electric field generator, arrays, rechargeable batteries and accessories.

Single-use arrays are placed directly on the skin in the region surrounding the tumor and connected to the electric field generator to deliver TTFields therapy.

Arrays are changed when hair growth or skin moisture reduces array adhesion to the skin.

The therapy is designed to be delivered continuously throughout the day and night, and efficacy is strongly correlated to time on therapy.

TTFields therapy is designed to be delivered continuously throughout the day and night.

When the device is turned on, TTFields are continuously generated within the specific region of the body covered by the arrays.

Healthy tissues located outside of this region remain unaffected by the therapy.

The electric field generator can be run from a standard power outlet or carried with a battery in a specially designed bag that we provide to patients.

We plan to use the same field generator technology across all indications for which our Products are approved.

Healthy tissue remain unaffected by the therapy.

The electric field generator can be powered by a battery or standard power outlet.

We plan to use similar field generator technology across all indications for which our Products are approved.

We plan to specifically target individual solid tumor types by optimizing field generator parameters such as frequency and power output.

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Optune Lua is approved for use in multiple countries for the treatment of MPM.

Optune Lua is also approved for use in the U.S.

for the treatment of NSCLC.

Optune Lua is also approved for use in the U.S., EU and Japan for the treatment of NSCLC.

Optune Pax is approved for use in the U.S.

for the treatment of pancreatic cancer.

Treatment of newly diagnosed GBM

In 2015, we received FDA approval to market Optune Gio (then known as Optune) for the treatment of adult patients with newly diagnosed supratentorial GBM in combination with temozolomide based on the randomized Phase 3 EF-14 trial ("EF-14"), which compared Optune Gio plus temozolomide versus temozolomide alone for the treatment of newly diagnosed GBM post radiation.

In 2015, we received FDA approval to market Optune Gio (then known as Optune) for the treatment of adult patients with newly diagnosed supratentorial GBM with temozolomide based on the randomized Phase 3 EF-14 trial ("EF-14"), which compared Optune Gio plus temozolomide versus temozolomide alone for the treatment of newly diagnosed GBM post radiation.

The trial met its primary endpoint of progression-free survival and a powered secondary endpoint was overall survival.

Patients treated with Optune Gio and temozolomide exhibited 6.7 and 20.9 months of median progression-free and overall survival, respectively, compared to 4.0 and and 16.0 months in patients treated with temozolomide alone.

Patients treated with Optune Gio and temozolomide exhibited 6.7 and 20.9 months of median progression-free and overall survival, respectively, compared to 4.0 and 16.0 months in patients treated with temozolomide alone.

The extension of overall survival and progression-free survival in patients receiving Optune Gio with temozolomide was not specific to any prognostic subgroup or tumor genetic marker and was consistent regardless of MGMT methylation status, extent of resection, age, performance status or gender.

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Patients treated with Optune Gio and temozolomide also demonstrated stable and comparable quality of life compared to patients treated with temozolomide alone, when evaluating physical, role, social, emotional and cognitive functioning, Post-hoc analyses of EF-14 have shown that increased time on therapy and higher TTFields intensity at the tumor bed are associated with increased survival.

The National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology ® (NCCN Guidelines ® ) for Central Nervous Systems Cancers were updated to include alternating electric fields therapy (Optune Gio) in combination with temozolomide following standard brain radiation therapy with concurrent temozolomide as a Category 1 recommended postoperative adjuvant treatment option for patients with newly diagnosed supratentorial GBM.

The National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology ® (NCCN Guidelines ® ) for Central Nervous Systems Cancers were updated to include alternating electric fields therapy (Optune Gio) with temozolomide following standard brain radiation therapy with concurrent temozolomide as a Category 1 recommended postoperative adjuvant treatment option for patients with newly diagnosed supratentorial GBM.

Treatment of recurrent GBM

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Patients randomized to receive Optune Gio monotherapy demonstrated 6.6 months of median overall survival, compared to 6.0 months in patients treated with physician's choice chemotherapy.

Chemotherapies chosen for the active control arm included mainly bevacizumab, nitrosoureas and temozolomide.

Chemotherapies chosen for the

active control arm included mainly bevacizumab, nitrosoureas and temozolomide.

The study demonstrated that Optune Gio provided clinically comparable survival with an overall better quality of life.

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Three patients in the Optune Gio alone arm had a complete response versus no patients in the active chemotherapy arm.

Final data from the EF-11 trial were published in the European Journal of Cancer in 2012.

In 2020, the EF-19 post-approval registry, which was a post-approval study required as a condition of FDA approval, confirmed the effectiveness and safety of Optune Gio as monotherapy and further strengthened Optune Gio's clinical profile in recurrent GBM.

The EF-19 study studied Optune Gio as a monotherapy for the treatment of recurrent GBM in 192 patients compared to the 117 recurrent GBM patients who received best standard of care chemotherapy in Novocure’s EF-11 registration study.

Optune Gio as monotherapy reduced the risk of death with

fewer adverse events compared to best standard of care chemotherapy.

Optune Gio as monotherapy reduced the risk of death with fewer adverse events compared to best standard of care chemotherapy.

For patients who received at least one course of therapy, Optune Gio prolonged survival by a median 1.7 months.

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LUNAR evaluated the safety and efficacy of TTFields therapy when used together with immune checkpoint inhibitors or docetaxel (collectively, "standard therapies") versus standard therapies alone for patients with stage 4 NSCLC who progressed during or after platinum-based therapy.

The LUNAR trial met its primary endpoint Patients treated with TTFields therapy and standard therapies demonstrated median overall survival of 13.2 months (95% CI, 10.3-15.5 months) compared to 9.9 months (95% CI, 8.2-12.2 months) in patients treated with standard therapies alone (p=0.042, HR=0.76).

The LUNAR trial met its primary endpoint.

Patients treated with TTFields therapy and standard therapies demonstrated median overall survival of 13.2 months (95% CI, 10.3-15.5 months) compared to 9.9 months (95% CI, 8.2-12.2 months) in patients treated with standard therapies alone (p=0.042, HR=0.76).

The one-year survival rate for patients treated with TTFields therapy and standard therapies was 53% (95% CI, 44%-61%) compared to 42% (95% CI, 34%-50%) in patients treated with standard therapies alone.

TTFields therapy was well-tolerated with no added systemic toxicities and few grade 3 device-related adverse events (no grade 4 or 5).

In 2023, the data from the LUNAR study were published in The Lancet Oncology , and additional data detailing the LUNAR study have since been presented at multiple medical congresses.

In 2023, the data from the LUNAR trial were published in The Lancet Oncology , and additional data detailing the LUNAR study have since been presented at multiple medical congresses.

Treatment of MPM

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The STELLAR data were published in The Lancet Oncology in 2019.

Treatment of Pancreatic Cancer

In 2026, we received FDA approval to market Optune Pax for the treatment of adult patients with locally advanced pancreatic cancer concurrent with gemcitabine and nab-paclitaxel based on the results from the randomized Phase

3 PANOVA-3 clinical trial ("PANOVA-3").

PANOVA-3 evaluated the safety and efficacy of TTFields therapy when used together with gemcitabine and nab-paclitaxel versus gemcitabine and nab-paclitaxel alone for patients with unresectable, locally advanced pancreatic cancer.

The PANOVA-3 trial met its primary endpoint.

Patients treated with TTFields therapy and gemcitabine and nab-paclitaxel demonstrated median overall survival of 16.2 months (95% CI, 15.0-18.0) compared to 14.2 months (95% CI, 12.8-15.4) in patients treated with gemcitabine and nab-paclitaxel alone (p=0.039, HR=0.82).

TTFields therapy was well-tolerated with no added systemic toxicities and few grade 3 device-related adverse events (no grade 4 or 5).

In 2025, the data from the PANOVA-3 trial were published in the Journal of Clinical Oncology .

Our commercial markets

We have built a commercial organization and market Optune Gio for the treatment of GBM in multiple countries and Optune Lua for the treatment of NSCLC in the U.S..

We have built a commercial organization and market Optune Gio for the treatment of GBM in multiple countries, Optune Lua for the treatment of NSCLC and MPM in the U.S., and Optune Pax for the treatment of pancreatic cancer in the U.S.

In 2026, we estimate that annually approximately:

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Of this population, approximately 8,200 patients are candidates for treatment with Optune Gio and will actively seek treatment.

• 4,600 people will be diagnosed with GBM or tumors that typically progress to GBM in Germany.

Of this population, approximately 2,500 patients are candidates for treatment with Optune Gio and will actively seek treatment.

Annual diagnoses rates per capita are similar in our other European active markets.

• 2,200 people will be diagnosed with GBM or tumors that typically progress to GBM in Japan.

Of this population, approximately 1,200 patients are candidates for treatment with Optune Gio and will actively seek treatment.

• 114,000 people will be diagnosed with metastatic NSCLC in the U.S.

We estimate that approximately 30,000 patients are candidates for second-line treatment with Optune Lua and will actively seek therapy.

We believe there are many more patients who could benefit from treatment with Optune Gio or Optune Lua and we continue to focus on increasing penetration for GBM and NSCLC.

• 60,000 people will be diagnosed with pancreatic ductal adenocarcinoma in the U.S.

We estimate that approximately 15,000 patients are candidates for first-line treatment with Optune Pax and will actively seek therapy.

We believe there are many more patients who could benefit from treatment with Optune Gio, Optune Lua and Optune Pax and we continue to focus on increasing penetration in our active markets.

In the future, we anticipate strategically expanding into additional geographic markets and additional indications, pending regulatory approval.

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As of December 31, 2025, we had 217 sales force colleagues globally.

Healthcare providers must undergo a certification training in order to prescribe our Products.

Our sales and marketing efforts are principally focused on driving adoption of Optune Gio and Optune Lua among medical oncologists, specialty oncologists focused on treatment of the brain and thorax, and radiation oncologists.

We continue to focus on driving key academic center engagement across all indications.

We currently operate as a direct-to-patient distributor of our Products, except in Japan.

In Japan, we distribute our Products through hospitals and provide patient support services under a contractual arrangement with the hospital.

Our sales and marketing efforts are principally focused on driving adoption of our Products among medical oncologists, specialty oncologists focused on treatment of the brain, thorax or abdomen, and radiation oncologists.

All healthcare providers must undergo a certification training in order to prescribe our Products.

We currently operate as a direct-to-patient distributor of our Products, except in certain countries, including Japan.

In those countries, we distribute our Products through hospitals and provide patient support services under a contractual arrangement with the hospital.

Once an eligible patient is identified by a certified prescriber, the healthcare provider’s office submits a prescription order form and supporting documentation to us.

We employ a team of Device Support Specialists who provide technical training to the patient and any caregivers.

Once treatment is initiated, we provide 24/7 technical support for patients and caregivers as well as assistance with insurance reimbursement.

Once treatment is initiated, we provide technical support for patients and caregivers as well as assistance with commercial insurance reimbursement, when applicable.

We also provide the healthcare provider and the patient with a usage report for monitoring patient time on therapy.

We believe we have the experience and expertise to scale our sales and marketing efforts.

Billing and reimbursement

We provide our Products directly to patients following receipt of a prescription order and a signed patient service agreement (except in Japan as described above).

We provide our Products directly to patients following receipt of a prescription order and a signed patient agreement (except in countries where we contract with hospitals as described above).

The number of active patients on therapy and the amount of net revenue recognized per active patient are our principal revenue drivers.

An active patient is a patient who is receiving treatment under a commercial prescription order as of the measurement date, including patients who may be on a temporary break from treatment and who plan to resume treatment in less than 60 days.

Growth in the number of active patients is a factor of both new patient starts and treatment duration.

We bill payers a single monthly fee for a month of therapy and we bear the financial risk of securing payment from third-party payers and patients in all markets except for Japan.

We distribute our Products through hospitals in Japan with the hospitals receiving reimbursement from the government-mandated insurance program and in turn contracting with us for the equipment, supplies and services necessary to treat patients with our Product.

Growth in the number of active patients is a function of both new patient starts and treatment duration.

We bill payers a single monthly fee for a month of therapy and we bear the financial risk of securing payment from third-party payers and patients in all markets except for countries where we contract with hospitals.

We distribute

our Products through hospitals in those other markets, with the hospitals receiving reimbursement from the government-mandated insurance program and in turn contracting with us for the equipment, supplies and services necessary to treat patients with our Product.

We maintain a monthly list price for our therapy.

We typically negotiate discounts from our list price with healthcare payers, and in certain cases we accept government-mandated discounts from our list prices in order to secure reimbursement for our Products.

We continue to work with payers to expand access to Optune Gio for patients with GBM.

As of December 31, 2024, we have received national reimbursement for Optune Gio in Austria, France, Germany, Israel, Japan, Sweden and Switzerland.

As of December 31, 2024 we have not yet received national reimbursement for Optune Lua for NSCLC in any of our active markets, however, we are seeking to obtain national reimbursement (and private insurance coverage, where available) in multiple countries.

We continue to work with payers to expand access to Optune Gio for patients with newly diagnosed GBM.

As of December 31, 2025, we have received national reimbursement for Optune Gio in Austria, Czechia, France, Germany, Israel, Japan, Spain, Sweden and Switzerland.

As of December 31, 2025 we have not yet received national reimbursement for Optune Lua for NSCLC or MPM or Optune Pax for pancreatic cancer in any of our active markets, however, we are seeking to obtain national reimbursement (and private insurance coverage, where available) in multiple countries.

In the U.S., a substantial majority of Americans with private health insurance had coverage of Optune Gio for newly diagnosed GBM and/or recurrent GBM as of December 31, 2025.

Americans who are beneficiaries of the Medicare fee-for-service program also have coverage of Optune Gio for newly diagnosed GBM.

We intend to pursue private

health insurance and Medicare coverage with CMS for Optune Lua for NSCLC.

We intend to pursue private health insurance and Medicare coverage with CMS for Optune Lua for NSCLC and Optune Pax for pancreatic cancer.

We cannot be certain when we will obtain such coverage or if we will be able to obtain such coverage at reasonable rates.

Our development pipeline

Based on the results of our preclinical and clinical research, we have developed a pipeline strategy to advance TTFields therapy through phase 2 and phase 3 studies across multiple solid tumor types where TTFields has shown efficacy, including GBM, NSCLC and pancreatic cancer.

Based on the results of our preclinical and clinical research, we have developed a pipeline strategy to advance TTFields therapy through Phase 2 and Phase 3 studies across multiple solid tumor types where TTFields has shown efficacy, including GBM, NSCLC, brain metastases from NSCLC and pancreatic cancer.

Current Development Pipeline

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Central Nervous System Indications

Brain metastases

Brain metastases from NSCLC

Metastatic cancer is cancer that has spread from the place where it first started to another place in the body.

In metastasis, cancer cells break away from where they first formed (the primary cancer), travel through the blood or lymph system, and form new tumors (the metastatic tumors) in other parts of the body.

The exact incidence of brain metastases is unknown because no national cancer registry documents brain metastases, and estimates from scientific literature vary greatly based on the study methodology applied.

Brain metastases are commonly treated with a combination of surgery and radiation.

The exact incidence of brain metastases from NSCLC is unknown because no national cancer registry documents brain metastases, and estimates from scientific literature vary greatly based on the study methodology applied.

Brain metastases from NSCLC are commonly treated with a combination of surgery and radiation.

Systemic therapies are often utilized to treat the primary tumor, but many systemic therapies do not cross the blood brain barrier and are thus ineffective in the treatment of brain metastases.

When brain metastases appear, they are either surgically removed or treated with radiation using stereotactic radiosurgery ("SRS") when possible.

Whole brain radiation therapy, although effective in delaying progression or recurrence of brain metastases when given either before or after SRS, is associated with neurotoxicity and a significant decline in cognitive functioning.

Thus, whole brain radiation therapy is often delayed until later in the disease course and is often used as a last resort.

This practice results in a window of unmet need after localized surgery and SRS are used and before whole brain radiation therapy is administered to delay or prevent the additional spread of brain metastases.

When brain metastases appear, they are either surgically removed or treated with stereotactic radiosurgery when possible.

Whole brain radiation therapy, although effective in delaying progression or recurrence of brain metastases when given either before or after stereotactic radiation, is associated with neurotoxicity and a significant decline in cognitive functioning and is thus reserved as a

salvage treatment.

This practice results in a window of unmet need after localized surgery and stereotactic radiation are used and before whole brain radiation therapy is administered to delay or prevent the additional spread of brain metastases.

METIS Phase 3 trial

In 2024, we presented data from the Phase 3 METIS trial, which evaluated the safety and efficacy of TTFields therapy and best supportive care ("BSC") compared to BSC alone in the treatment of adult patients with brain metastases resulting from NSCLC following stereotactic radiosurgery.

METIS met its primary endpoint, demonstrating a statistically significant improvement in time to intracranial progression in patients randomized to receive TTFields therapy.

Patients treated with TTFields therapy and BSC exhibited a median time to intracranial progression of 21.9 months compared to 11.3 months in patients treated with BSC alone (n=298;

Median TTFields therapy treatment duration was 16 weeks and median usage was 67%.

Consistent with previous studies, TTFields therapy was well-tolerated with sustained quality of life and neurocognitive function.

Baseline characteristics were well balanced between arms.

We estimate that approximately 16,000 patients meet the criteria of the METIS trial and actively seek treatment in the U.S.

We intend to submit the data from METIS to regulatory authorities and publish these findings in a peer-reviewed scientific journal.

In 2024, we received Breakthrough Device designation from the FDA for the use of TTFields therapy in the treatment of brain metastases from NSCLC and are currently in pre-submission discussions with the FDA in anticipation of filing a PMA application in 2025, with potential launch in 2026.

The median time to intracranial progression was 15.0 months in patients treated with TTFields therapy and BSC compared to 7.5 months in patients treated with BSC alone.

We estimate that approximately 16,000 patients meet the criteria of the METIS trial and will actively seek treatment in the U.S.

In December 2025 we submitted the final module of the PMA, seeking approval under the proposed brand name Optune Mya ® .

The PMA has been accepted as filed by the FDA, and is under substantive review .

GBM is the most common and aggressive form of primary brain cancer.

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TRIDENT Phase 3 trial

In January 2024, the final patient was enrolled in our TRIDENT trial ("TRIDENT"), a Phase 3 study testing the potential survival benefit of initiating Optune Gio concurrent with radiation therapy and maintenance temozolomide in patients with newly diagnosed GBM.

In 2024, the final patient was enrolled in our TRIDENT trial ("TRIDENT"), a Phase 3 study testing the potential survival benefit of initiating Optune Gio use concurrent with radiation therapy and maintenance temozolomide in adult patients diagnosed with newly diagnosed GBM.

The primary endpoint is overall survival.

Secondary endpoints include, but are not limited to, progression-free survival, survival rates at one and two years, overall radiological response, severity and frequency of adverse effects, pathological changes in resected GBM tumors post treatment, quality of life, and correlation of overall survival to TTFields dose.

TRIDENT was designed to accrue 950 patients with a 24-month minimum follow-up period after the last patient is enrolled.

Final data from the TRIDENT trial is anticipated in 2026.

981 patients were enrolled in TRIDENT with a 24-month minimum follow-up period after the last patient enrolled.

Topline data from the TRIDENT trial is anticipated in the second quarter of 2026.

KEYNOTE D58 Phase 3 trial

In 2024, the FDA accepted the investigational new drug application for the randomized, double blind, placebo controlled Phase 3 KEYNOTE D58 clinical trial ("KEYNOTE D58").

KEYNOTE D58 is evaluating the use of TTFields therapy together with temozolomide and pembrolizumab for the treatment of adult patients with newly diagnosed GBM.

KEYNOTE D58 is evaluating the use of TTFields therapy together with temozolomide and pembrolizumab for the treatment of adult patients diagnosed with newly diagnosed GBM.

KEYNOTE D58 was designed to accrue 741 patients with a 24-month minimum follow-up period after the last patient is enrolled.

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KEYNOTE D58 was designed and is being conducted as part of a clinical collaboration between Novocure and MSD, a tradename of Merck & Co., Inc.

KEYNOTE D58 is currently open and enrolling.

KEYNOTE D58 is currently open and enrolling, and we anticipate completing enrollment by the end of 2026.

Torso Indications

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While overall cancer incidence and death rates are remaining stable or declining, the incidence and death rates for pancreatic cancer are increasing.

We estimate that approximately 60,000 patients are diagnosed with pancreatic cancer each year in the U.S.

We estimate that approximately 60,000 patients are diagnosed with pancreatic ductal adenocarcinoma each year in the U.S.

Pancreatic cancer has a five-year relative survival rate of just 10 percent.

Physicians use different combinations of surgery, radiation and pharmacological therapies to treat pancreatic cancer, depending on the stage of the disease.

For patients with locally advanced pancreatic cancer involving encasement of arteries but no extra-pancreatic disease, the standard of care is surgery followed by chemotherapy

with or without radiation.

For patients with locally advanced pancreatic cancer involving

encasement of arteries but no extra-pancreatic disease, the standard of care is surgery followed by chemotherapy with or without radiation.

Unfortunately, the majority of locally advanced cases are diagnosed once the cancer is no longer operable, generally leaving chemotherapy with or without radiation as the only treatment option.

PANOVA-4 Phase 2 trial

In 2024, we announced top-line results from the Phase 3 PANOVA-3 trial, which evaluated the safety and efficacy of TTFields therapy together with gemcitabine and nab-paclitaxel compared to gemcitabine and nab-paclitaxel alone for the treatment of unresectable, locally advanced pancreatic cancer.

PANOVA-3 met its primary endpoint, demonstrating a statistically significant improvement in overall survival in patients randomized to receive TTFields therapy.

Patients treated with TTFields therapy together with gemcitabine and nab-paclitaxel demonstrated 16.20 median overall survival compared to 14.16 months in patients treated with gemcitabine and nab-paclitaxel alone (n=571, HR=0.819, p=0.039).

The survival rate benefit for patients treated with TTFields therapy increased over time with a 13% improve in the overall survival rate at 12 months and a 33% overall survival rate at 24month.

Consistent with previous studies, TTFields therapy was well-tolerated.

We estimate that approximately 15,000 patients meet the criteria of the PANOVA-3 trial and actively seek treatment in the U.S.

We intend to share the PANOVA-3 data at an upcoming scientific congress, to submit these data for publication in a peer-reviewed scientific journal and to submit the data to regulatory authorities.

In 2024, we received Breakthrough Device designation from the FDA for the use of TTFields therapy in the treatment unresectable, locally advanced pancreatic cancer together with gemcitabine and nab-paclitaxel and are currently in pre-submission discussions with the FDA in anticipation of filing a PMA application in 2025, with potential launch in 2026.

PANOVA-4 Phase 2 trial

In 2024, we completed enrollment in the Phase 2 PANOVA-4 trial ("PANOVA-4") evaluating the safety and efficacy of TTFields therapy together with atezolizumab, gemcitabine and nab-paclitaxel in the treatment of metastatic pancreatic cancer.

In 2024, we completed enrollment in the Phase 2 PANOVA-4 trial ("PANOVA-4") evaluating the safety and efficacy of TTFields therapy use together with atezolizumab, gemcitabine and nab-paclitaxel in the treatment of adult patients diagnosed with metastatic pancreatic cancer.

The primary endpoint of PANOVA-4 is disease control rate.

Secondary endpoints include, but are not limited to, overall survival, progression-free survival, one-year survival, objective response rate and frequency and severity of adverse events.

PANOVA-4 was designed to accrue 76 patients with a 12-month follow-up period following enrollment of the last patient.

84 patients were enrolled in PANOVA-4 with a 12-month minimum follow-up period after the last patient enrolled.

PANOVA-4 was designed and is being conducted as part of a clinical collaboration between Novocure and Roche.

Final data from the PANOVA-4 trial is anticipated in 2026.

Topline data from the PANOVA-4 trial is anticipated in the first quarter of 2026.

Non-small cell lung cancer

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LUNAR-2 Phase 3 trial

In July 2023, the FDA accepted the investigation device exemption for the LUNAR-2 clinical trial ("LUNAR-2"), a randomized, Phase 3 study evaluating the efficacy of TTFields therapy concomitant with pembrolizumab and platinum-based chemotherapy for the treatment of patients with metastatic NSCLC.

In July 2023, the FDA accepted the investigation device exemption for the LUNAR-2 clinical trial ("LUNAR-2"), a randomized, Phase 3 study evaluating the efficacy of TTFields therapy use concomitant with pembrolizumab and platinum-based chemotherapy as first-line treatment for adult patients diagnosed with metastatic NSCLC.

The two primary endpoints of LUNAR-2 are overall survival and progression-free survival.

Secondary endpoints include, but are not limited to, progression-free survival and overall survival according to patient histology, progression-free survival and overall survival according to patient tumor proportion score, one-, two-, and three-year survival rates, objective response rate, duration of response, disease control rate and severity and frequency of adverse effects.

LUNAR-2 is designed

to accrue 734 patients with a 21-month follow-up following the enrollment of the last patient.

LUNAR-2 is currently open and enrolling.

LUNAR-4 Phase 2 trial

In 2024, the FDA accepted the investigation device exemption for the LUNAR-4 clinical trial ("LUNAR-4"), a Phase 2 trial evaluating the safety and efficacy of TTFields therapy concomitant with pembrolizumab for the treatment of patients with metastatic NSCLC following previous treatment with PD-1/PD-L1 inhibitor and platinum-based chemotherapy.

The primary endpoint of LUNAR-4 is overall survival.

Secondary endpoints include, but are not limited to, overall survival and progression-free survival according to patient histology and tumor proportion score, and safety.

LUNAR-4 is designed to accrue 69 patients with a 12-month follow-up following the enrollment of the last patient.

LUNAR-2 is designed to accrue 734 patients with a 21-month minimum follow-up period following the enrollment of the last patient.

LUNAR-2 is currently open and enrolling.

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EF-31 Phase 2 trial

In 2022, we announced the final results from our EF-31 Phase 2 study, a single-arm study evaluating the safety and efficacy of TTFields therapy together with XELOX chemotherapy (and trastuzumab for HER2-positive patients) as first-line treatment for patients with unresectable gastric adenocarcinoma or gastroesophageal junction adenocarcinoma in partnership with Zai.

In 26 evaluable patients, the primary endpoint, confirmed objective response rate, was 50%, median progression-free survival was 7.8 months, duration of response was 10.3 months and median overall survival had not yet been reached with a one-year survival rate of 72%.

In 2022, we announced the final results from our EF-31 Phase 2 study, a single-arm study evaluating the safety and efficacy of TTFields therapy use together with XELOX chemotherapy (and trastuzumab for HER2-positive patients) as first-line treatment for adult patients diagnosed with unresectable gastric adenocarcinoma or gastroesophageal junction adenocarcinoma in partnership with Zai.

In 26 evaluable patients, confirmed objective response rate, the primary endpoint, was 50%, median progression-free survival was 7.8 months, duration of response was 10.3 months and median overall survival had not yet been reached with a one-year survival rate of 72%.

HEPANOVA Phase 2 trial

In 2021, we announced the final results of our HEPANOVA Phase 2 trial, a single-arm study evaluating the safety and efficacy of TTFields therapy in combination with sorafenib for the treatment of advanced hepatocellular cancer.

In 21 evaluable patients, HEPANOVA showed a 9.5% objective response rate and 76% disease control rate, as well as 5.8 months of progression free survival, compared to historical control data showing a 4.5% objective response rate and 43% disease control rate for patients treated with sorafenib alone.

In 2021, we announced the final results of our HEPANOVA Phase 2 trial, a single-arm study evaluating the safety and efficacy of TTFields therapy use in combination with sorafenib for the treatment of adult patients diagnosed with advanced hepatocellular cancer.

In 21 evaluable patients, HEPANOVA showed a 9.5% objective response rate and

76% disease control rate, as well as 5.8 months of progression free survival, compared to historical control data showing a 4.5% objective response rate and 43% disease control rate for patients treated with sorafenib alone.

Ovarian cancer

INNOVATE-3 Phase 3 trial

In 2024 , we presented results from the Phase 3 INNOVATE-3 trial ("INNOVATE-3"), studying the effectiveness of TTFields therapy with paclitaxel in patients with platinum-resistant ovarian cancer.

In 2024 , we presented results from the Phase 3 INNOVATE-3 trial ("INNOVATE-3"), studying the effectiveness of TTFields therapy use with paclitaxel in adult patients diagnosed with platinum-resistant ovarian cancer.

INNOVATE-3 did not meet its primary endpoint of overall survival at the final analysis.

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The collaboration agreement grants Zai a license to commercialize our Products in Greater China and establishes a development partnership intended to accelerate the development of TTFields therapy in multiple solid tumor cancer indications.

Zai has launched Optune Gio for the

treatment of newly diagnosed GBM in Hong Kong and mainland China, is seeking marketing authorization for GBM in Taiwan.

Zai has launched Optune Gio for the treatment of newly diagnosed GBM in Hong Kong and mainland China, is seeking marketing authorization for GBM in Taiwan.

For additional information, see Note 12 to the Consolidated Financial Statements.

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These agreements also generally provide that we own, or the individual is required to assign to us, all inventions conceived by the individual in the course of rendering services to us.

Despite measures taken to protect our intellectual property, unauthorized parties may copy certain aspects of our products or obtain and use information that we believe is proprietary.

Despite measures taken to protect our intellectual

property, unauthorized parties may copy certain aspects of our products or obtain and use information that we believe is proprietary.

Pursuant to our strategic collaboration with Zai, we granted Zai a license to commercialize TTFields therapy in Greater China.

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Even after the expiration of our patents, we believe that potential market entrants applying low-intensity, alternating electric fields to solid tumors will have to undertake their own clinical studies and regulatory submissions to prove equivalence to our Products, a necessary step in receiving regulatory approvals for a competing product, all while avoiding infringing our unexpired patents.

Presently, the traditional biotechnology, pharmaceutical and medical technology industries expend significant resources in developing novel and proprietary therapies for the treatment of solid tumors, including GBM, MPM and other indications that we are currently investigating.

Presently, the traditional biotechnology, pharmaceutical and medical technology industries expend significant resources in developing novel and proprietary therapies for the treatment of solid tumors, including GBM, NSCLC, pancreatic cancer, MPM and other indications that we are currently investigating.

As we work to increase market acceptance of our Products, we compete with companies commercializing or investigating other anti-cancer therapies, some of which are in clinical studies for GBM, NSCLC or MPM that currently specifically exclude patients who have been or are being treated with our Products.

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In the UK, advertising and promotion is subject to the UK Regulations, general guidance and enforcement of the Medicines and Healthcare products Regulatory Agency (MHRA), and adherence to the Association of British HealthTech Industries (ABHI) Code of Ethical Business Practices.

Promotional activities for FDA-regulated products of other companies have been the subject of government enforcement actions brought under healthcare laws and consumer protection statutes.

Promotional activities for FDA-regulated products of other companies have been the subject of

government enforcement actions brought under healthcare laws and consumer protection statutes.

In addition, we are required to meet analogous regulatory requirements in countries outside the U.S., which can change rapidly with relatively short notice.

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Premarket approval (PMA) and Humanitarian Device Exemption (HDE) pathways

Optune Gio and Optune Lua are classified as Class III devices as they are deemed to be life-sustaining devices.

Optune Gio, Optune Lua and Optune Pax are classified as Class III devices as they are deemed to be life-sustaining devices.

Accordingly, we were required to obtain PMA approval for Optune Gio, which the FDA granted in April 2011 and October 2015 for the treatment of recurrent and newly diagnosed supratentorial GBM, respectively, in adult patients.

We were also required to obtain PMA approval for Optune Lua for use concurrent with PD-1/PD-L1 inhibitors or docetaxel in adult patients with metastatic NSCLC who have progressed on or after a platinum-based regimen, which the FDA granted in October 2024.

We were also required to obtain PMA approval for Optune Pax for use concurrent with gemcitabine and nab-paclitaxel in adult patients with locally advanced pancreatic cancer, which the FDA granted in February 2026.

In 2025, we submitted a PMA application to the FDA based on the results of the Phase 3 METIS clinical trial which evaluated TTFields therapy use for the treatment of brain metastases from NSCLC.

We expect that we will be required to obtain PMA approval for the use of our Products for future indications.

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The FDA may or may not accept the panel’s recommendation.

In addition, the FDA will generally conduct a pre-approval inspection of the manufacturing facility or facilities to ensure compliance with the QSR.

In addition, the FDA will generally conduct a pre-approval inspection of the manufacturing facility or facilities to ensure compliance with the QSR and BiMo audits of the sponsor and/or investigational sites.

Prior to approval of the Optune Gio PMA for the treatment of recurrent GBM, we and our critical component suppliers were each inspected by the FDA.

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As is typical with medical device companies, we have received approval for a number of post-approval PMA supplements for our approved Products, including for modifications to the electric field generator, arrays, software, manufacturing processes and labeling.

Future modifications may be considered by us as the need arises, some of

which we may deem to require a PMA supplement application and others to require reporting in our PMA Annual Report.

Future modifications may be considered by us as the need arises, some of which we may deem to require a PMA supplement application and others to require reporting in our PMA Annual Report.

For class III devices intended to treat disease affecting 8,000 individuals or less per year in the U.S., called Humanitarian Use Devices ("HUD"), the FDA has a separate marketing authorization pathway called the HDE.

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Following the issuance of this CE Certificate, we can draw up a declaration of conformity and affix the CE mark to the devices covered by this CE Certificate.

The time required to CE mark our

devices or to obtain approval from other non-U.S.

The time required to CE mark our devices or to obtain approval from other non-U.S.

authorities is not defined, and therefore may be longer or shorter than that required for FDA approval.

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Our devices could be subject to voluntary recall if we, the FDA or another applicable regulatory authority determine, for any reason, that our devices pose a risk of injury or are otherwise defective.

Moreover, the FDA and other

applicable regulatory authorities can order a mandatory recall if there is a reasonable probability that our device would cause serious adverse health consequences or death.

Moreover, the FDA and other applicable regulatory authorities can order a mandatory recall if there is a reasonable probability that our device would cause serious adverse health consequences or death.

The FDA has broad post-market and regulatory enforcement powers.

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Although there are a number of statutory exceptions and regulatory safe harbors that protect certain common activities from prosecution under the law, the exceptions and safe harbors are drawn narrowly and practices that involve the provision of remuneration intended to induce ordering, purchasing, leasing or recommending of a medical device may be subject to scrutiny if they do not qualify for an exception or safe harbor.

In some cases, our practices may not meet

all of the technical elements for protection under a federal Anti-Kickback Statute exception or safe harbor.

In some cases, our practices may not meet all of the technical elements for protection under a federal Anti-Kickback Statute exception or safe harbor.

Similarly, as a supplier, we are also subject to the federal beneficiary anti-inducement statute, which prohibits us from offering any remuneration to a beneficiary of Medicare or Medicaid that is likely to influence that beneficiary’s choice of therapy, unless an exception applies.

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The healthcare fraud provision prohibits knowingly and willfully executing a scheme to defraud any healthcare benefit program, including private third-party payers.

The false statements provision prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.

The false statements provision

prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.

Many states have similar healthcare fraud laws or insurance fraud laws that apply to claims for healthcare reimbursement.

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We have adopted policies and codes of conduct regarding our interactions with Covered Recipients and believe we are in material compliance with the Sunshine Act.

However, our failure to adhere to these requirements could materially adversely

impact our business and financial results.

However, our failure to adhere to these requirements could materially adversely impact our business and financial results.

Additionally, a number of states have transparency reporting requirements similar to (and in some cases broader than) the Sunshine Act, and regulations similar to the Sunshine Act have been adopted in foreign countries including a number of EU member states.

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We compete with other medical device, pharmaceutical and life sciences companies to recruit, hire, train and retain the personnel that we anticipate we will need.

Because our current Products require, and we anticipate our future Products will require, physician training and education, we expect that our sales and marketing and patient support teams will continue to grow substantially as we expand our approved indications and markets.

In November 2023, we announced a series of actions to strengthen and optimize our business operations to support near-term growth drivers and long-term value creation.

The plan included a reduction in headcount of approximately 200 employees or 13% of our then current workforce.

Field-based commercial and field-based medical employees were minimally affected.

We expect that the workforce reduction, along with other actions, will enable us to fund future growth priorities without an associated increase in expected forward operating cash burn.

We continue to focus resources on our global commercial infrastructure and launch preparation ahead of our anticipated indication in metastatic non-small cell lung cancer and on high-potential research and development programs.

Available information

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business