Latest news with #Novocure
Business Wire
24-07-2025
- Business
- Business Wire
Novocure Reports Second Quarter 2025 Financial Results
BAAR, Switzerland--(BUSINESS WIRE)--Novocure (NASDAQ: NVCR) today reported financial results for the second quarter that ended June 30, 2025. Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercializing its innovative therapy, Tumor Treating Fields (TTFields). 'With the first half of 2025 complete, I am pleased to report continued progress towards our clinical, regulatory and commercial milestones. In Q2, we grew our glioblastoma and non-small cell lung cancer businesses and advanced our efforts to bring Tumor Treating Fields therapy to new patient populations,' said Ashley Cordova, CEO, Novocure. 'With one launch ongoing and two more on the horizon, we are well-positioned in both the near and long term. This is a pivotal period for Novocure.' Financial updates for the second quarter ended June 30, 2025: Total net revenues for the quarter were $158.8 million, an increase of 6% compared to the same period in 2024. This increase is primarily driven by active patient growth across our major markets. The U.S., Germany, France and Japan contributed $94.3 million, $19.1 million, $18.4 million and $9.5 million, respectively, with other active markets contributing $13.0 million. Revenue in Greater China from Novocure's partnership with Zai Lab totaled $4.6 million. Recognized revenue from Optune Lua ® in the quarter was $2.4 million, including $1.1 million from non-small cell lung cancer (NSCLC) and $1.3 million from malignant pleural mesothelioma (MPM). Gross margin for the quarter was 74% compared to 77% in the prior year. The reduction of gross margin was primarily driven by the roll out of our Head Flexible Electrode (HFE) transducer array for use with Optune Gio ®, the NSCLC launch where we are treating on-label patients at risk prior to establishing broad reimbursement, and increased tariffs. Research, development and clinical studies expenses for the quarter were $55.8 million, an increase of 2% from the same period in 2024. This was primarily driven by increased direct clinical trial expenses related to the ramp of the LUNAR-2 and KEYNOTE D58 trials. Sales and marketing expenses for the quarter were $57.1 million, an increase of 1% compared to the same period in 2024. This primarily reflects higher costs associated with the expansion of our NSCLC sales force. General and administrative expenses for the quarter were $44.0 million, an increase of 17% compared to the same period in 2024. This increase was primarily driven by higher share-based compensation expenses and higher personnel and professional service expenses to support the NSCLC launch and general company build-out, particularly on the enterprise technology side. Net loss for the quarter was $40.1 million with loss per share of $0.36. Adjusted EBITDA* for the quarter was $(9.9) million. Cash, cash equivalents and short-term investments were $911.5 million as of June 30, 2025. Operational updates for the second quarter ended June 30, 2025: As of June 30, 2025, there were 4,331 total active patients on TTFields therapy globally. Optune Gio 1,598 prescriptions for Optune Gio for the treatment of glioblastoma were received in the quarter, a decrease of 1% from the same period in 2024. The U.S., Germany, France and Japan contributed 963; 199; 179 and 101 prescriptions, respectively, with the remaining 156 prescriptions contributed by other active markets. As of June 30, 2025, there were 4,194 Optune Gio active patients on therapy, an increase of 7% from the same period in 2024. The U.S., Germany, France and Japan contributed 2,177; 581; 453 and 451 Optune Gio active patients, respectively, with the remaining 532 active patients contributed by other active markets. Optune Lua 143 total prescriptions for Optune Lua were received in the quarter. 121 Optune Lua prescriptions were received for the treatment of NSCLC and 22 prescriptions were received for the treatment of MPM. As of June 30, 2025, there were 137 active Optune Lua patients on therapy, including 94 patients treated for metastatic NSCLC and 43 patients treated for MPM. Quarterly updates and achievements: In May 2025, Novocure presented the results of the Phase 3 PANOVA-3 clinical trial at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. PANOVA-3 met its primary endpoint, demonstrating a statistically significant extension in overall survival in patients treated with TTFields therapy together with gemcitabine and nab-paclitaxel compared to gemcitabine and nab-paclitaxel alone. Patients treated with TTFields therapy also exhibited a statistically significant extension in pain-free survival (secondary endpoint) and distant progression-free survival (post hoc analysis). The presentation was selected for inclusion in 'Best of ASCO' program and the data were simultaneously published in the Journal of Clinical Oncology. In July 2025, Novocure presented final quality of life data from the PANOVA-3 trial at the European Society for Medical Oncology (ESMO) Gastrointestinal Cancers Congress 2025. Patients treated with TTFields therapy demonstrated a statistically significant and clinically meaningful benefit across multiple quality of life measures of pain (secondary endpoint) and significantly delayed the need for opioid pain medication (post hoc analysis) for patients with unresectable, locally advanced pancreatic adenocarcinoma. A significant delay in deterioration across measures of health status was observed, preserving quality of life longer in patients treated with TTFields therapy. Anticipated clinical and regulatory milestones: Novocure plans the submission of a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the treatment of unresectable, locally advanced pancreatic cancer based on results of the Phase 3 PANOVA-3 clinical trial in Q3 2025. Novocure plans the submission of a PMA application to the FDA for the treatment of brain metastases from NSCLC based on results of the Phase 3 METIS clinical trial in H2 2025. The topline data readout from the Phase 2 PANOVA-4 clinical trial in metastatic pancreatic cancer is expected in H1 2026. The topline data readout from the Phase 3 TRIDENT clinical trial in newly diagnosed glioblastoma is expected in H1 2026. Conference call details Novocure will host a conference call and webcast to discuss second quarter 2025 financial results at 8:00 a.m. EDT today, Thursday, July 24, 2025. To access the conference call by phone, use the following conference call registration link and dial-in details will be provided. To access the webcast, use the following webcast registration link. The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure's website, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD. 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, non-small cell lung cancer, malignant pleural mesothelioma and pleural mesothelioma. Novocure has several additional ongoing or completed clinical trials exploring the use of Tumor Treating Fields therapy in the treatment of glioblastoma, non-small cell lung cancer and pancreatic cancer. Novocure's global headquarters is located in Baar, Switzerland, with U.S. headquarters located in Portsmouth, New Hampshire and research and development facilities located in Haifa, Israel. For additional information about the company, please visit and follow @Novocure on LinkedIn and X (Twitter). *Non-GAAP Financial Measurements We measure our performance based upon a non-U.S. GAAP measurement of earnings before interest, taxes, depreciation, amortization and shared-based compensation ("Adjusted EBITDA"). We believe Adjusted EBITDA is useful to investors in evaluating our operating performance because it helps investors compare the results of our operations from period to period by removing the impact of earnings attributable to our capital structure, tax rate and material non-cash items, specifically share-based compensation. 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 trial 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 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 27, 2025, and subsequent filings 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. Consolidated Balance Sheets USD in thousands (except share data) NOVOCURE LIMITED AND SUBSIDIARIES U.S. dollars in thousands (except share data) June 30, 2025 December 31, 2024 Unaudited Audited ASSETS CURRENT ASSETS: Cash and cash equivalents $ 149,624 $ 163,767 Short-term investments 761,901 796,106 Restricted cash 2,509 2,327 Trade receivables, net 89,915 74,226 Receivables and prepaid expenses 39,139 35,063 Inventories 40,211 35,086 Total current assets 1,083,299 1,106,575 LONG-TERM ASSETS: Property and equipment, net 80,333 77,660 Field equipment, net 18,591 14,811 Right-of-use assets 48,089 27,120 Other long-term assets 15,563 14,618 Total long-term assets 162,576 134,209 TOTAL ASSETS $ 1,245,875 $ 1,240,784 Expand Consolidated Balance Sheets USD in thousands (except share data) Non-U.S. GAAP Financial Measures Reconciliation USD in thousands Active Patients on Therapy June 30, 2025 2024 Optune Gio Optune Lua Total Optune Gio Optune Lua Total Active patients at period end (1) United States 2,177 98 2,275 2,163 12 2,175 International markets: Germany 581 33 614 527 11 538 France 453 — 453 369 — 369 Japan 451 — 451 403 — 403 Other international 532 6 538 475 3 478 International markets - Total 2,017 39 2,056 1,774 14 1,788 4,194 137 4,331 3,937 26 3,963 Expand (1) Optune Lua includes both active patients in NSCLC and MPM. Worldwide, there were 43 and 25 active MPM patients on therapy as of June 30, 2025 and 2024 and 94 and 1 active NSCLC patient(s) on therapy as of June 30, 2025 and 2024. Expand Important Safety Information What is Optune Gio ® approved to treat? Optune Gio is a wearable, portable, FDA-approved device indicated to treat a type of brain cancer called glioblastoma multiforme (GBM) in adult patients 22 years of age or older. Newly diagnosed GBM If you have newly diagnosed GBM, Optune Gio is used together with a chemotherapy called temozolomide (TMZ) if: Your cancer is confirmed by your healthcare professional AND You have had surgery to remove as much of the tumor as possible Recurrent GBM If your tumor has come back, Optune Gio can be used alone as an alternative to standard medical therapy if: You have tried surgery and radiation and they did not work or are no longer working AND You have tried chemotherapy and your GBM has been confirmed by your healthcare professional Who should not use Optune Gio? Optune Gio is not for everyone. Talk to your doctor if you have: An implanted medical device (programmable shunt), skull defect (missing bone with no replacement), or bullet fragment. Optune Gio has not been tested in people with implanted electronic devices, which may cause the devices not to work properly, and Optune Gio has not been tested in people with skull defects or bullet fragments, which may cause Optune Gio not to work properly A known sensitivity to conductive hydrogels (the gel on the arrays placed on the scalp like the ones used on EKGs). When Optune Gio comes into contact with the skin, it may cause more redness and itching or may rarely cause a life-threatening allergic reaction Do not use Optune Gio if you are pregnant or are planning to become pregnant. It is not known if Optune Gio is safe or effective during pregnancy. What should I know before using Optune Gio? Optune Gio should only be used after receiving training from qualified personnel, such as your doctor, a nurse, or other medical staff who have completed a training course given by Novocure ®, the maker of Optune Gio. Do not use any parts that did not come with the Optune Gio Treatment Kit sent to you by Novocure or given to you by your doctor Do not get the device or transducer arrays wet If you have an underlying serious skin condition on the scalp, discuss with your doctor whether this may prevent or temporarily interfere with Optune Gio treatment What are the possible side effects of Optune Gio? Most common side effects of Optune Gio when used together with chemotherapy (temozolomide, or TMZ) were low blood platelet count, nausea, constipation, vomiting, tiredness, scalp irritation from the device, headache, seizure, and depression. The most common side effects when using Optune Gio alone were scalp irritation (redness and itchiness) and headache. Other side effects were malaise, muscle twitching, fall and skin ulcers. Talk to your doctor if you have any of these side effects or questions. Please visit for Instructions For Use (IFU) for complete information regarding the device's indications, contraindications, warnings, and precautions. Important Safety Information What is Optune Lua ® approved to treat? Optune Lua is a wearable, portable, FDA-approved device used together with PD-1/PD-L1 inhibitors (immunotherapy) or docetaxel. It is indicated for adult patients with metastatic non-small cell lung cancer (mNSCLC) who have progressed on or after a platinum-based regimen. Who should not use Optune Lua? Optune Lua for mNSCLC is not for everyone. Talk to your doctor if you have: An electrical implant. Use of Optune Lua together with electrical implants has not been tested and may cause the implanted device not to work properly A known sensitivity to gels like the gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes. In this case, skin contact with the gel used with Optune Lua may commonly cause increased redness and itching, and rarely may even lead to severe allergies such as a fall in blood pressure and difficulty breathing Do not use Optune Lua if you are pregnant or are planning to become pregnant. It is not known if Optune Lua is safe or effective during pregnancy. What should I know before using Optune Lua? Optune Lua should only be used after receiving training from qualified personnel, such as your doctor, a nurse, or other medical staff who have completed a training course given by Novocure ®, the maker of Optune Lua. Do not use any parts that did not come with Optune Lua Treatment Kit sent to you by Novocure or given to you by your doctor Do not get the device or transducer arrays wet Please be aware that Optune Lua has a cord that plugs into an electrical socket. Be careful of tripping when it's connected If you have an underlying serious skin condition where the transducer arrays are placed, discuss with your doctor whether this may prevent or temporarily interfere with Optune Lua treatment. What are the possible side effects of Optune Lua? The most common side effects of Optune Lua when used together with certain immunotherapy and chemotherapy drugs were dermatitis, pain in the muscles, bones, or joints, fatigue, anemia, alopecia (hair loss), dyspnea, nausea, cough, diarrhea, anorexia, pruritus (itching), leukopenia, pneumonia, respiratory tract infection, localized edema (swelling), rash, pain, constipation, skin ulcers, hypokalemia (low potassium levels), hypoalbuminemia (low albumin levels), hyponatremia (low sodium levels), and dysphagia (difficulty swallowing). Other potential adverse effects associated with the use of Optune Lua include treatment related skin irritation, allergic reaction to the adhesive or to the gel, overheating of the array leading to pain and/or local skin burns, infections at site where the arrays make contact with the skin, local warmth and tingling sensation beneath the arrays, medical device site reaction, muscle twitching, and skin breakdown/skin ulcer. Talk to your doctor if you have any of these side effects or questions.
Business Wire
01-07-2025
- Business
- Business Wire
Novocure to Present Final Secondary Endpoint Data from the Phase 3 PANOVA-3 Trial of Tumor Treating Fields (TTFields) in Pancreatic Cancer at the ESMO Gastrointestinal Cancers Congress 2025
BAAR, Switzerland--(BUSINESS WIRE)--Novocure (NASDAQ: NVCR) announced today that it will present the final secondary endpoint results from the Phase 3 PANOVA-3 trial of its Tumor Treating Fields (TTFields) therapy for unresectable, locally advanced pancreatic cancer. These data from PANOVA-3 were accepted as a late-breaking abstract for oral presentation at the European Society for Medical Oncology (ESMO) Gastrointestinal Cancers Congress 2025, taking place July 2 to July 5 in Barcelona, Spain. 'In the PANOVA-3 trial, there was a significant improvement in overall survival and a significant delay in the progression of pain as well as delayed opioid medication use in patients treated with Tumor Treating Fields and chemotherapy compared to chemotherapy alone. Pancreatic cancer is associated with debilitating pain. Delaying these symptoms can preserve a patient's overall quality of life, a promising outcome we observed in this trial,' said Teresa Macarulla, MD, PhD, Medical Oncologist at Hospital Universitari Vall d'Hebron and Head of the Gastrointestinal and Endocrine Tumors Group at the Vall d'Hebron Institute of Oncology (VHIO). 'The overall survival and quality of life results in PANOVA-3 support Tumor Treating Fields therapy with gemcitabine and nab-paclitaxel as a potential standard of care for unresectable, locally advanced pancreatic cancer.' The PANOVA-3 trial evaluated the use of TTFields therapy concomitantly with gemcitabine and nab-paclitaxel (GnP) as a first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma, compared to GnP alone. The trial met its primary endpoint, demonstrating a statistically significant improvement in median overall survival for patients treated with TTFields. 'The PANOVA-3 results illustrate that Tumor Treating Fields therapy can significantly improve clinical outcomes for patients, including overall survival, in unresectable, locally advanced pancreatic cancer,' said Nicolas Leupin, MD, PhD, Chief Medical Officer, Novocure. 'These new data show that Tumor Treating Fields therapy can also have a meaningful impact preserving patients' quality of life by delaying worsening symptoms of pancreatic cancer. We look forward to submitting a premarket application for Tumor Treating Fields therapy to the FDA in the second half of 2025.' Results from PANOVA-3 The primary endpoint of overall survival and several secondary endpoints, including pain-free survival, from PANOVA-3 were previously reported at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The additional secondary endpoint data to be presented at the ESMO Gastrointestinal Cancers Congress 2025 are the full quality of life outcomes as well as a post-hoc analysis of the time to first opioid use. The quality of life outcomes were measured using the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) with the pancreatic cancer specific PAN26 addendum scales. The EORTC QLQ-C30 and the PAN26 measure global health status and function as well as symptoms including pain (irrespective of cause), pancreatic pain, and gastrointestinal symptoms. There was a statistically significant delay in the time to deterioration in global health status for patients treated with TTFields concomitant with GnP compared to patients treated with GnP alone, with a median of 7.1 months compared to 5.7 months, respectively, p=0.023. The delay in time to deterioration due to pain (irrespective of cause) was statistically significant in patients treated with TTFields concomitant with GnP compared to patients treated with GnP alone, with a median 10.1 months compared to 7.4 months, respectively, p=0.003. Similarly, the delay in time to deterioration due to pancreatic pain was statistically significant in patients treated with TTFields concomitant with GnP compared to patients treated with GnP alone, with a median of 14.7 months compared to 10.2 months, respectively, p=0.006. These results complement the statistically significant extension in pain-free survival reported at the 2025 ASCO Annual Meeting, which was defined as the time between randomization until a ≥20-point increase of pain using a visual analog scale (VAS) from baseline or death. Patients treated with TTFields concomitant with GnP had a median pain-free survival of 15.2 months compared to a median 9.1 months in the group treated with GnP alone; HR 0.74 (95% CI: 0.56–0.97) p=0.027. All gastrointestinal symptom scales included in the EORTC QLQ-C30 and PAN26, except for indigestion and altered bowel habit, significantly favored patients treated with TTFields concomitant with GnP. In a post-hoc analysis, time to first opioid use was significantly longer with TTFields and GnP compared to patients treated with GnP alone, with a median of 7.1 months compared to 5.4 months, respectively, p=0.046. TTFields therapy was well-tolerated, no new safety signals were observed, and device related safety outcomes were consistent with prior clinical studies using TTFields. Mild to moderate skin adverse events (AEs) were the most common device-related AEs. The company will also present two posters of preclinical data from its pancreatic cancer development program. Data Presentation Details Oral Presentation: Late Breaking Abstract #LBA3: PANOVA-3: Pain and quality of life (QoL) outcomes with Tumor Treating Fields (TTFields) therapy in patients with locally advanced pancreatic adenocarcinoma (LAPC) Presenting Author: Teresa Macarulla, MD, PhD, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO), Spain Time and Location: July 3, 2:10 PM CEST / 8:10 AM EDT, Barcelona Room Poster #311P: Effectiveness of tumor treating fields (TTFields) together with gemcitabine and nab-paclitaxel in pancreatic ductal adenocarcinoma (PDAC) preclinical models Time and Location: July 3, 3:30 – 4:30 PM CEST / 9:30 – 10:30 AM EDT, Exhibition Area Poster #316P: Pancreatic cancer cells are sensitized to FOLFIRINOX treatment by co-application with tumor treating fields (TTFields) Time and Location: July 3, 3:30 – 4:30 PM CEST / 9:30 – 10:30 AM EDT, Exhibition Area About PANOVA-3 PANOVA-3 is an international, prospective, randomized, open-label, controlled Phase 3 clinical trial designed to test the efficacy and safety of Tumor Treating Fields (TTFields) therapy used concomitantly with gemcitabine and nab-paclitaxel, as a first-line treatment for locally advanced pancreatic adenocarcinoma. Patients were randomized to receive either TTFields therapy concomitant with gemcitabine and nab-paclitaxel or gemcitabine and nab-paclitaxel alone. The primary endpoint is overall survival. Secondary endpoints include progression-free survival, local progression-free survival, objective response rate, one-year survival rate, quality of life, pain-free survival, puncture-free survival, resectability rate, and toxicity. The PANOVA-3 trial enrolled 571 patients who were randomized 1:1 and followed for a minimum of 18 months. About Pancreatic Cancer Pancreatic cancer is one of the most lethal cancers and is the third most frequent cause of death from cancer in the U.S. i and the fifth most frequent cause in Europe. ii While overall cancer incidence and death rates are remaining stable or declining, the incidence and death rates for pancreatic cancer are increasing. iii It is estimated that approximately 67,000 patients are diagnosed with pancreatic cancer each year in the U.S. iv and the global incidence is more than 500,000. v Pancreatic cancer has a five-year relative survival rate of just 13%. vi 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. Unfortunately, most locally advanced cases are diagnosed when the cancer is no longer operable, generally leaving chemotherapy with or without radiation as the only treatment option. About Tumor Treating Fields 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. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these 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 targeted therapies 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 TTFields therapy and its multifaceted effect on cancer cells, visit 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, non-small cell lung cancer, malignant pleural mesothelioma and pleural mesothelioma. Novocure has several additional ongoing or completed clinical trials exploring the use of Tumor Treating Fields therapy in the treatment of glioblastoma, non-small cell lung cancer and pancreatic cancer. Novocure's global headquarters is located in Baar, Switzerland, with U.S. headquarters located in Portsmouth, New Hampshire and research and development facilities located in Haifa, Israel. For additional information about the company, please visit 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 trial 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 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 27, 2025, and subsequent filings 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. ii International Agency for Research on Cancer. Cancer TODAY 2024. Data version: Globocan 2022. Accessed June 24, 2025. v International Agency for Research on Cancer. Cancer TODAY 2024. Data version: Globocan 2022. Accessed June 24, 2025. vi American Cancer Society. Cancer Facts & Figures 2025. Atlanta: American Cancer Society; 2025
Business Wire
30-06-2025
- Business
- Business Wire
Novocure to Report Second Quarter 2025 Financial Results
BAAR, Switzerland--(BUSINESS WIRE)--Novocure (NASDAQ: NVCR) will report financial results for the second quarter 2025 on July 24, 2025, before the U.S. financial markets open. Novocure management will host a conference call and webcast at 8:00 a.m. EDT, July 24, to discuss the company's financial results for the three- and six-month periods that ended June 30, 2025. To access the conference call by phone, use the following conference call registration link and dial-in details will be provided. To access the webcast, use the following webcast registration link. The slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure's website, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD. 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, non-small cell lung cancer, malignant pleural mesothelioma and pleural mesothelioma. Novocure has several additional ongoing or completed clinical trials exploring the use of Tumor Treating Fields therapy in the treatment of glioblastoma, non-small cell lung cancer and pancreatic cancer. Novocure's global headquarters is located in Baar, Switzerland, with U.S. headquarters located in Portsmouth, New Hampshire and research and development facilities located in Haifa, Israel. For additional information about the company, please visit 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 'could' '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 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 27, 2025, and subsequent filings 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.
Business Insider
02-06-2025
- Health
- Business Insider
Novocure announces results from Phase 3 PANOVA-3 trial
Novocure (NVCR) announced that results from the Phase 3 PANOVA-3 trial of Tumor Treating Fields therapy for pancreatic cancer will be presented at the 2025 American Society of Clinical Oncology, ASCO, Annual Meeting in Chicago and simultaneously published in the Journal of Clinical Oncology. The trial met its primary endpoint, demonstrating a statistically significant improvement in median overall survival for patients treated with TTFields. TTFields therapy concomitant with gemcitabine and nab-paclitaxel demonstrated improvement in several secondary endpoints including the one-year survival rate and pain-free survival. The one-year survival rate showed a statistically significant improvement in the TTFields concomitant with gemcitabine and nab-paclitaxel treated group with compared to those who received gemcitabine and nab-paclitaxel alone. Patients treated with TTFields concomitant with gemcitabine and nab-paclitaxel had a median pain-free survival of 15.2 months compared to a median 9.1 months in the group treated with gemcitabine and nab-paclitaxel alone. This is a statistically significant 6.1-month extension in pain-free survival. Pain-free survival was defined as the time from baseline until an increase of 20 or more points was reported by patients on a visual scale for pain or until death.
Associated Press
01-06-2025
- Business
- Associated Press
Zai Lab and Novocure Announce Results From the Phase 3 PANOVA-3 Trial of Tumor Treating Fields (TTFields) Therapy for Pancreatic Cancer to be Presented at 2025 ASCO Annual Meeting
SHANGHAI & CAMBRIDGE, Mass. & BAAR, Switzerland--(BUSINESS WIRE)--May 31, 2025-- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) and Novocure (NASDAQ: NVCR) announced that results from the Phase 3 PANOVA-3 trial of Tumor Treating Fields (TTFields) therapy for pancreatic cancer will be presented today at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago and simultaneously published in the Journal of Clinical Oncology. 'The data presented today from the PANOVA-3 trial of Tumor Treating Fields show a clinically meaningful and statistically significant improvement in overall survival for people with locally advanced pancreatic cancer,' said Vincent Picozzi, MD, MMM, medical oncologist and investigator in the PANOVA-3 trial. 'Importantly, we also saw an extension in the duration of time before pain progressed. Pain is a hallmark of this disease, and as a clinician, the potential of this therapy to address this aspect of pancreatic cancer is very encouraging. These results illustrate the potential of Tumor Treating Fields therapy concomitant with gemcitabine and nab-paclitaxel to become a standard of care for unresectable, locally advanced pancreatic cancer.' The Phase 3 PANOVA-3 trial evaluated the use of TTFields therapy concomitantly with gemcitabine and nab-paclitaxel as a first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma compared to gemcitabine and nab-paclitaxel alone. The trial met its primary endpoint, demonstrating a statistically significant improvement in median overall survival (mOS) for patients treated with TTFields. 'The encouraging data from the Phase 3 PANOVA-3 study demonstrate a meaningful improvement in outcomes for patients with unresectable, locally advanced pancreatic cancer—including pain reduction and a statistically significant improvement in overall survival,' said Rafael Amado, M.D., President, Head of Global Research and Development at Zai Lab. 'Pancreatic cancer remains one of the most challenging cancers to treat globally, with approximately 134,000 new cases diagnosed annually in China alone. Zai Lab participated in this trial and looks forward to continuing our collaboration with Novocure to bring this innovative therapy to patients in China as quickly as possible.' 'Most people with pancreatic cancer are diagnosed with advanced disease, which is very difficult to treat and only about 1 in 10 people are alive five years after diagnosis,' said Nicolas Leupin, MD, PhD, Chief Medical Officer, Novocure. 'The results shared today at ASCO and in the Journal of Clinical Oncology demonstrate that Tumor Treating Fields therapy improved overall survival and pain-free survival in unresectable, locally advanced pancreatic cancer. We plan to submit these data to the FDA in the second half of 2025 to support a premarket approval for Tumor Treating Fields therapy.' Results from PANOVA-3 In the intent-to-treat population, patients treated with TTFields therapy concomitantly with gemcitabine and nab-paclitaxel had an mOS of 16.2 months compared to 14.2 months for patients treated with gemcitabine and nab-paclitaxel alone, a statistically significant 2.0-month improvement [hazard ratio (HR) 0.82; p=0.039 (N=571)]. TTFields therapy concomitant with gemcitabine and nab-paclitaxel demonstrated improvement in several secondary endpoints including the one-year survival rate and pain-free survival. Pancreatic cancer can cause significant pain as the disease progresses and managing pain is a key clinical challenge. Quality of life was also measured as a secondary endpoint. Analyses were performed for all patients using the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) with the pancreatic cancer specific PAN26 addendum. Deterioration-free survival in global health status, pain and digestive problems were significantly improved in patients receiving TTFields therapy concomitant with gemcitabine and nab-paclitaxel compared to the gemcitabine and nab-paclitaxel alone group. Full analysis of the quality of life results in PANOVA-3 will be shared at a future scientific conference. There was no statistically significant difference in additional secondary outcome measures of progression-free survival, local progression-free survival, objective response rate, puncture-free survival or tumor resectability rate between the TTFields with gemcitabine and nab-paclitaxel and the gemcitabine and nab-paclitaxel arms. TTFields therapy was well-tolerated, no new safety signals were observed, and safety was consistent with prior clinical studies. Mild to moderate skin adverse events (AEs) were the most common device-related AEs. Data Presentation & Publication Details The PANOVA-3 data, (LBA 3500) Phase 3 study of Tumor Treating Fields (TTFields) with gemcitabine and nab-paclitaxel for locally advanced pancreatic ductal adenocarcinoma (LA-PAC), will be presented today by Dr. Picozzi in Hall D1 during the 3:00 – 6:00 p.m. Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary oral session. The Phase 3 PANOVA-3 publication in the Journal of Clinical Oncology, Tumor Treating Fields with gemcitabine and nab-paclitaxel for locally advanced pancreatic adenocarcinoma: randomized, open-label, pivotal phase 3 PANOVA-3 study , will be available online at Novocure Investor Event Novocure will host an investor event featuring Dr. Picozzi and Novocure leadership after the oral presentation. Event details and a link to a live webcast of the event are available on the investor relations page of For more information or to request in-person attendance, please contact Novocure investor relations at [email protected]. Regulatory & Ongoing Clinical Study of TTFields for Pancreatic Cancer Novocure plans to file for regulatory approval for use of TTFields therapy in unresectable, locally advanced pancreatic adenocarcinoma based on PANOVA-3 in the U.S. in the second half of 2025. The company also plans to file for regulatory approval in EU, Japan and other key markets. Novocure continues to follow patients in its Phase 2 PANOVA-4 trial exploring the use of TTFields therapy together with atezolizumab, gemcitabine and nab-paclitaxel for the treatment of metastatic pancreatic cancer. PANOVA-4 has completed enrollment with data anticipated in the first half of 2026. About PANOVA-3 PANOVA-3 is an international prospective, randomized, open-label, controlled Phase 3 clinical trial designed to test the efficacy and safety of Tumor Treating Fields (TTFields) therapy used concomitantly with gemcitabine and nab-paclitaxel, as a first-line treatment for locally advanced pancreatic adenocarcinoma. Patients were randomized to receive either TTFields therapy concomitant with gemcitabine and nab-paclitaxel or gemcitabine and nab-paclitaxel alone. The primary endpoint is overall survival. Secondary endpoints include progression-free survival, local progression-free survival, objective response rate, one-year survival rate, quality of life, pain-free survival, puncture-free survival, resectability rate, and toxicity. The PANOVA-3 trial enrolled 571 patients who were randomized 1:1 and followed for a minimum of 18 months. About PANOVA-4 PANOVA-4 is an international, multi-center, Phase 2 clinical trial designed to test the safety and efficacy of Tumor Treating Fields (TTFields) therapy together with atezolizumab, gemcitabine and nab-paclitaxel for the treatment of metastatic pancreatic cancer. The primary endpoint is disease control rate. Secondary endpoints include overall survival, progression-free survival, one-year survival rate, objective response rate, progression-free survival at six months, duration of response, and toxicity. The study is designed to enroll 76 patients and enrollment is complete. About Pancreatic Cancer in China Pancreatic cancer is one of the most common and deadliest cancers globally. In China, there were an estimated 134,374 new cases in 2022, and it is now the eighth most common cancer type 1. The current median survival of patients with locally advanced, unresectable pancreatic cancer is nine to twelve months, and the five-year survival rate was 7.2% 2, making it the malignancy with the lowest survival rate in China. 1 Xia C, Dong X, Li H et al. Cancer statistics in China and United States, 2022: profiles, trends, and determinants. Chin Med J (Engl) 2022; 135: 584-590. 2 Hu JX, Zhao CF, Chen WB et al. Pancreatic cancer: A review of epidemiology, trend, and risk factors. World J Gastroenterol 2021; 27: 4298-4321. About Tumor Treating Fields 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. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these 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 targeted therapies 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 TTFields therapy and its multifaceted effect on cancer cells, visit About Zai Lab Zai Lab is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health worldwide. For additional information about Zai Lab, please visit or follow us at , 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, non-small cell lung cancer, malignant pleural mesothelioma and pleural mesothelioma. Novocure has several additional ongoing or completed clinical trials exploring the use of Tumor Treating Fields therapy in the treatment of glioblastoma, non-small cell lung cancer and pancreatic cancer. Novocure's global headquarters is located in Baar, Switzerland, with U.S. headquarters located in Portsmouth, New Hampshire and research and development facilities located in Haifa, Israel. For additional information about the company, please visit and follow @Novocure on LinkedIn and Twitter. Zai Lab Forward-Looking Statements This press release contains forward-looking statements about future expectations, plans, and prospects for Zai Lab, including, without limitation, statements regarding the prospects of and plans for developing and commercializing TTFields therapy, the potential benefits of TTFields therapy, and the potential treatment of pancreatic cancer. These forward-looking statements may contain words such as 'aim,' 'anticipate,' 'believe,' 'could,' 'estimate,' 'expect,' 'forecast,' 'goal,' 'intend,' 'may,' 'plan,' 'possible,' 'potential,' 'will,' 'would,' and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact or guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business initiatives, (3) the results of clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) risks related to doing business in China, and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission (SEC). We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Our SEC filings can be found on our website at and the SEC's website at View source version on CONTACT: For more information, please contact: Zai Lab Investor Relations: Christine Chiou / Lina Zhang +1 (917) 886-6929 / +86 136 8257 6943 [email protected]/[email protected] Zai Lab Media: Shaun Maccoun / Xiaoyu Chen +1 (857) 270-8854 / +86 185 0015 5011 [email protected]/[email protected] Novocure Investors: Ingrid Goldberg [email protected] Novocure Media: Catherine Falcetti [email protected] KEYWORD: ILLINOIS MASSACHUSETTS SWITZERLAND CHINA UNITED STATES NORTH AMERICA ASIA PACIFIC EUROPE INDUSTRY KEYWORD: RESEARCH FDA CLINICAL TRIALS BIOTECHNOLOGY HEALTH PHARMACEUTICAL GENERAL HEALTH SCIENCE ONCOLOGY SOURCE: Zai Lab Limited Copyright Business Wire 2025. PUB: 05/31/2025 03:08 PM/DISC: 05/31/2025 03:07 PM
