On October 30, 2025 Forlong Biotechnology, a clinical-stage biotech company focusing on developing transformative cytokine therapies for patients with severe unmet needs, reported that a late-breaking abstract featuring interim safety and efficacy data from a Phase 1 study evaluating the Company’s novel IL-15 superagonist, FL115, has been selected for poster presentation at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2025) being held November 5-9, 2025, in National Harbour, Maryland.

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FL115 is an engineered IL-15/IL15Rα-Fbody fusion protein, aiming to enhance anti-tumor immunity via IL-15-mediated signaling on NK and CD8+ T cells while minimizing complexity from Fc. Fbody is a single-chain Fc designed to eliminate classical Fc effects including ADCC/CDC/ADCP while retaining FcRn engagement. Multiple Phase 1 clinical studies for FL115 as a monotherapy are being completed. FL115 is currently being investigated in combination with Bacillus Calmette-Guérin (BCG) in a Phase 2 clinical trial to evaluate safety and preliminary efficacy in patients with nonmuscle invasive bladder cancer (NMIBC) and in combination with an anti-PD1 monoclonal antibody in a Phase 1b/2 clinical trial to evaluate safety and preliminary efficacy in patients with advanced solid tumors.

"Our mission is to leverage our synthetic immunology platforms to engineer cytokines to fine tune the immune system, providing cancer patients with novel treatment options," said Dong Wei, Ph.D., Chief Executive Officer of Forlong Biotechnology, "IL-15 has long been believed to be an attractive cytokine for cancer immunotherapy, and fusing Fbody to IL-15/IL15Rα complex presents a differentiated IL-15 superagonist profile for the treatment of solid tumors. We appreciate the opportunity to present initial data from our Phase 1 study of FL115 to leading immuno-oncology experts in this prestigious late-breaking forum."

Poster Details:

Program: FL115
Poster Title: Preliminary safety, pharmacokinetics, pharmacodynamics and efficacy of FL115, a novel IL-15 superagonist, from a Phase 1 study in patients with advanced solid tumors
Abstract Number: 1334
Presenter: Dong Wei, Ph.D., CEO, Forlong Biotechnology
Date & Time: Saturday, November 8, 2025

About FL115

FL115 is an engineered IL-15/IL15Rα-Fbody fusion protein, aiming to enhance anti-tumor immunity via IL-15-mediated signaling on NK and CD8+ T cells while minimizing complexity from Fc. FL115 has demonstrated significant anti-tumor activities as a monotherapy or as part of combination therapy in vivo, and can be manufactured by a robust and efficient process with excellent product stability. Clinically, FL115 has demonstrated favorable safety profile and preliminary clinical responses as a monotherapy, and has the best-in-class potential to synergize with current and emerging T cell-targeting immunotherapies through combination therapy to significantly improve the treatment outcome for patients. It is currently being investigated in combination with Bacillus Calmette-Guérin (BCG) in a Phase 2 clinical trial to evaluate safety and preliminary efficacy in patients with nonmuscle invasive bladder cancer (NMIBC) and in combination with an anti-PD1 monoclonal antibody in a Phase 1b/2 clinical trial to evaluate safety and preliminary efficacy in patients with advanced solid tumors.

(Press release, Forlong Biotechnology, OCT 30, 2025, View Source [SID1234657182])

On October 30, 2025 Sandoz (SIX: SDZ / OTCQX: SDZNY), the global leader in affordable medicines, reported its net-sales performance for the nine months and third quarter ended September 30, 2025.

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9M net sales of USD 8,057 million
up by 5% at constant currencies (CC1) and in USD; up by 6% at comparable growth rates (CGR2). Volume growth of 8%
ten largest-selling medicines grew by combined 9% at CC and represented 34% of net sales
Q3 net sales of USD 2,825 million
up by 6% at CC and by 9% in USD, respectively; up by 7% at CGR. Volume growth of 8%
biosimilars represented more than 30% of net sales for first time
All regions in growth at CC in both periods. Europe 9M net sales grew by 6% at CC, while International was up by 4% at CC (by 6% when adjusted2 for 2024 China divestment). North America grew by 1% at CC (by 7% when adjusted2 for Cimerli acquisition)
Successful launches so far this year, in line with roadmap: primarily in US, including Wyost & Jubbonti(denosumab) and Pyzchiva (ustekinumab)
Anticipated biosimilar launches in fourth quarter include European rollouts of Wyost & Jubbontiand Afqlir (aflibercept), as well as Tyruko (natalizumab) in US
Full-year 2025 guidance: mid-single-digit net-sales growth at CC (unchanged); a core EBITDA margin of 21-22% (prior guidance: around 21%)
Doctor and patient with child
Richard Saynor, Chief Executive Officer of Sandoz, commented: "The third quarter once again demonstrated the ability of Sandoz to deliver on its commitments and execute against the strategic roadmap. Our comprehensive launch program is helping us expand access to affordable medicines for more patients.

Looking ahead, Sandoz is well-positioned to capitalize on significant growth opportunities, and we control our ability to seize them. We are making strong progress in building our biosimilar infrastructure, advancing our pipeline, and strengthening our capabilities, all supported by consistent financial performance. These are the reasons I am so confident in a Sandoz future reflected in compelling growth that underpins our Purpose to pioneer access for patients."

FULL-YEAR 2025 GUIDANCE

The Company has updated its 2025 financial guidance today:

FY 2025 net sales to grow by a mid-single-digit percentage at CC (unchanged)
a core EBITDA margin in FY 2025 of 21-22% (prior guidance: around 21%)
This guidance excludes any impacts of unforeseen events or unconfirmed developments, such as significant further potential trade tariffs emanating from the US government.

Remco Steenbergen, Chief Financial Officer of Sandoz, commented: "The upgrade in our guidance for the year particularly reflects the success of our biosimilars and the excellence in execution by colleagues around the world. Our ambition is unrelenting; we aim to fully exploit the many opportunities ahead which we believe will deliver sustained strong results over the long term."

US SETTLEMENT: AFLIBERCEPT

Sandoz recently announced that it has reached an agreement with Regeneron Pharmaceuticals, Inc., to resolve all patent disputes between the two companies relating to the US FDA-approved Sandoz aflibercept biosimilar. Under the terms of the agreement, Sandoz may enter the US market with a biosimilar version of Eylea in the fourth quarter of 2026, or earlier in certain circumstances.

PENICILLINS: TRADE DISTORTION

As part of its vertically integrated penicillins production, the Company sells certain amounts of active pharmaceutical ingredients (APIs) to other businesses. Recently, the imposition of tariffs by the US government has led to reduced exports from China to the US, prompting Chinese suppliers to significantly lower prices for key penicillin APIs, including 6-APA, the foundational compound for all penicillins. This price drop has coincided with an increase in market supply.

As the last remaining fully vertically integrated penicillins producer in Europe, Sandoz is pleased to see growing recognition by policymakers of the need for sustainable European supply, but more action is required. The Company calls on the European Union and national governments to implement measures that reduce geopolitical exposure and safeguard long-term sustainability of European-produced penicillins.

KEY LINKS

A conference call and webcast for investors and analysts will begin today at 9am CET. Details can be found here, with the accompanying presentation here.

CALENDAR

The Company intends to publish its full-year results on February 25, 2026.

9M AND Q3 2025 NET SALES

By business

9M

9M 2025 %
net sales 9M 2024 change
USD m USD m USD % CC % CGR %

Net sales 8,057 7,642 5% 5% 6%
Generics 5,699 71% 5,558 3% 2% 2%
Biosimilars 2,358 29% 2,084 13% 12% 17%
9M net sales were USD 8,057 million, up by 5% at CC and by 6% at CGR. Volumes grew by 8%, partly offset by price erosion of 3%; this decline was in line with a full-year assumption of low to mid-single-digit erosion. Net-sales growth was primarily driven by the performance of biosimilars, which continue to benefit from an extensive pipeline and launch program.

Generics overview

Net sales of generics in the first nine months were USD 5,699 million, reflecting growth of 2% at CC and CGR. Generics represented 71% of net sales (9M 2024: 73%, Q3 2025: 69%).

The increase in 9M net sales of generics in Europe was driven by the impact of launches in 2024 and 2025. International net sales of generics grew, after adjusting for the 2024 divestment of the Sandoz business in China. In North America, generics net-sales growth benefited from the successful Q4 2024 launch of paclitaxel.

Biosimilars overview

Net sales of biosimilars of USD 2,358 million in the first nine months reflected growth of 12% at CC and 17% at CGR. Biosimilars represented 29% of total net sales (9M 2024: 27%, Q3 2025: 31%).

Strong Europe biosimilars 9M net-sales growth at CC benefited from several good performances, including Pyzchiva and Tyruko, while excellent International biosimilar net-sales growth reflected the strong contribution from Omnitrope (somatropin) and Hyrimoz (adalimumab). Wyost and Jubbonti were launched in Q3 2025 in the International region.

North America biosimilar net sales declined at CC, reflecting the withdrawal of Cimerli in Q1 2025 and the impact of private-label adalimumab pricing dynamics; excluding the effect of the withdrawal, North America biosimilar net sales grew by a double-digit percentage at CC, partly a result of the strong launch of Wyost and Jubbonti.

Q3

Q3 2025 %
net sales Q3 2024 change
USD m USD m USD % CC % CGR %

Net sales 2,825 2,595 9% 6% 7%
Generics 1,963 69% 1,854 6% 3% 3%
Biosimilars 862 31% 741 16% 13% 17%
Net sales for the third quarter were USD 2,825 million, up by 6% at CC and by 7% at CGR. Volumes grew by 8%, partly offset by price erosion of 2%.

By region

9M

9M 2025 %
net sales 9M 2024 change
USD m USD m USD % CC % CGR %

Net sales 8,057 7,642 5% 5% 6%
Europe 4,362 54% 3,996 9% 6% 6%
International 1,943 24% 1,904 2% 4% 6%
North America 1,752 22% 1,742 1% 1% 7%

Europe overview

9M net sales in Europe were USD 4,362 million, reflecting growth of 6% at CC and CGR. Europe 9M net sales of generics grew at CC, strongly surpassed by the performance of biosimilars. Notable growth included that from Pyzchiva and Tyruko.

International overview

9M net sales in International amounted to USD 1,943 million, with good growth of 4% at CC and 6% at CGR. International net sales of generics declined at CC but grew at CGR, with an exceptional biosimilars result driven by the strong performances of Omnitrope and Hyrimoz.

North America overview

9M net sales in North America were USD 1,752 million, reflecting an increase of 1% at CC. Growth at CGR however, namely excluding the impact of the acquisition of Cimerli, amounted to 7%. The increase in North America net sales of generics was driven by the successful Q4 2024 launch of paclitaxel, as well as continued strong growth in Canada, while the region delivered strong biosimilar net-sales growth at CGR.

Q3

Q3 2025 %
net sales Q3 2024 change
USD m USD m USD % CC % CGR %

Net sales 2,825 2,595 9% 6% 7%
Europe 1,530 54% 1,362 12% 6% 6%
International 659 23% 635 4% 4% 4%
North America 636 23% 598 6% 7% 12%

APPENDIX

HISTORIC NET SALES

The Company intends to provide the net-sales performance by region by generics/biosimilars at each half-year and full-year results.

2025

By business

Q1 2025 change Q2 2025 change H1 2025 change
USD m USD % CC % USD m USD % CC % USD m USD % CC %
Net sales 2,480 0% 3% 2,752 8% 5% 5,232 4% 4%
Generics 1,809 -3% 0% 1,927 5% 2% 3,736 1% 1%
Biosimilars 671 8% 11% 825 15% 12% 1,496 11% 12%
Q3 2025 change 9M 2025 change
USD m USD % CC % USD m USD % CC %
Net sales 2,825 9% 6% 8,057 5% 5%
Generics 1,963 6% 3% 5,699 3% 2%
Biosimilars 862 16% 13% 2,358 13% 12%

By region

Q1 2025 change Q2 2025 change H1 2025 change
USD m USD % CC % USD m USD % CC % USD m USD % CC %
Net sales 2,480 0% 3% 2,752 8% 5% 5,232 4% 4%
Europe 1,372 3% 7% 1,460 12% 6% 2,832 8% 6%
International 590 -8% -2% 694 11% 11% 1,284 1% 5%
North America 518 -1% 1% 598 -4% -3% 1,116 -2% -1%

Q3 2025 change 9M 2025 change
USD m USD % CC % USD m USD % CC %
Net sales 2,825 9% 6% 8,057 5% 5%
Europe 1,530 12% 6% 4,362 9% 6%
International 659 4% 4% 1,943 2% 4%
North America 636 6% 7% 1,752 1% 1%

2024

Q1 2024 % change Q2 2024 % change Q3 2024 % change Q4 2024 % change
USD m USD CC USD m USD CC USD m USD CC USD m USD CC
Net sales 2,492 5% 6% 2,555 7% 9% 2,595 11% 12% 2,715 7% 9%
Generics 1,869 0% 1% 1,835 -1% 1% 1,854 3% 4% 1,946 1% 4%
Biosimilars 623 21% 21% 720 35% 37% 741 36% 37% 769 23% 25%

Q1 2024 % change Q2 2024 % change Q3 2024 % change Q4 2024 % change
USD m USD CC USD m USD CC USD m USD CC USD m USD CC
Net sales 2,492 5% 6% 2,555 7% 9% 2,595 11% 12% 2,715 7% 9%
Europe 1,326 4% 2% 1,308 2% 3% 1,362 13% 12% 1,367 7% 8%
International 642 4% 12% 627 5% 9% 635 2% 8% 653 0% 6%
North America 524 6% 6% 620 22% 23% 598 17% 18% 695 13% 14%

(Press release, Sandoz, OCT 30, 2025, View Source [SID1234657117])

On October 30, 2025 Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported to have strengthened its financial position through different capital markets activities. As a result, Evaxion now has cash on hand to fund its operations and R&D programs into the second half of 2027, extended from first half of 2027.

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In total, Evaxion has raised $7.2 million in recent weeks, with $4.5 million coming from sale of shares in an at-the-market (ATM) offering and $2.7 million coming from exercise of investor warrants.

The proceeds strengthens both Evaxion’s cash position and equity and follows the influx of $7.5 million paid by MSD (tradename of Merck & Co., Inc., Rahway, NJ, USA) when licensing vaccine candidate EVX-B3 in September 2025.

"We are pleased to have bolstered our cash position thereby extending our runway into the second half of 2027, allowing us to fully focus on executing on our strategy and plans," says Thomas Schmidt, CFO of Evaxion.

The recent exercises of investor warrants have reduced the number of outstanding warrants to purchase Evaxion ADSs by 1.0 million. The total number of outstanding warrants is now 2.8 million, including employee warrants, with a weighted average exercise price of $10.94.

Evaxion expects to accumulate an operational cash spend of $14 million in 2025. By the end of the second quarter 2025, Evaxion had cash at hand of $14.7 million. We have since had a gross inflow of cash of $14.7 million as mentioned above.

Evaxion had debt of $9.2 million by the end of the second quarter 2025. The debt was reduced by $4.1 million through a debt-to-equity conversion agreement with the European Investment Bank in July 2025, also bolstering Evaxion’s equity.

(Press release, Evaxion Biotech, OCT 30, 2025, View Source [SID1234657148])

On October 30, 2025 REGiMMUNE Limited ("REGiMMUNE" or "the Company"), a clinical stage biopharma company developing novel immune therapeutics targeting regulatory T cells (Treg), reported preclinical data of its antibody program at the meeting of Antibody Engineering & Therapeutics Asia 2025 in Kyoto, Japan from Oct. 20 – 22.

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REGiMMUNE, while pursuing RGI-2001 in advanced clinical development for (Graft vs Host Disease (GvHD), armed with our long-time expertise in human immunology and Treg cells, has been actively developing its therapeutic antibody program. This pipeline currently includes RGI-6004 and AB01, both targeting tumor infiltrating Treg cells, reflecting the two strategies of therapeutic modulation of Treg cells, namely, depleting vs silencing, and AB08-H1 targeting a surface marker shared by blood-borne and solid malignancies.

The presentation in Kyoto included RGI-6004 and AB08-H1. RGI-6004 was developed to highly selectively target tumor infiltrating Treg cells while maintaining all other immune effector cells intact to alleviate the immune suppression in the tumor microenvironment, and consequently enhance anti-cancer immunity. AB08-H1 is an antibody developed to kill malignant cells of Hodgkin & Non-Hodgkin diseases and solid cancer cells via a unique target.

RGI-6004, an Afucosylated Antibody to Target GARP/LAP-TGFβ1 for Selective Depletion of Activated Tregs. RGI-6004, a fully human IgG1 against GARP/Latent-TGFb1 complex, designed to deplete tumor infiltrating activated Treg cells. The antibody specifically binds to activated human Treg cells with high affinity, but none to non-activated Treg cells, and CD4+ and CD8+ T effector cells. The antibody recognizes tumor infiltrating Treg cells in clinical solid tumor tissues. Its afucosylated version highly selectively depletes activated Treg cells with a significantly enhanced efficacy of ~10 pM, but none of CD4+ and CD8+ effector T cells, while granzyme B induction & proliferation of CD4+ and CD8+ effector T cells are not affected. RGI-6004 has minimal impact on platelets (counts and degranulation), minimal binding to major immune cells, nor observable impact on hematological profile of normal human blood. In cynomolgus monkey, its t1/2 is shown to be ~10 days, while its clinical hematology, coagulation, blood chemistry, immunophenotyping in peripheral blood, serum cytokine analysis, and pathology, does not demonstrate safety alarms. In sum, the behavior of RGI-6004 highlights the potential as a next-generation Treg-depleting agent in cancer immunotherapy.

AB08-H1, A humanized antibody that directly kills cancer target cells without ADCC and CDC. AB08-H1 is a humanized IgG that specifically targets pan MHC II (synonym for HLA II, human leukocyte antigen). Upon binding to the cell surface MHC class II molecule, the antibody induces homotypic aggregation, lysosomal membrane permeabilization, and ultimately cell lysis of the target malignant cells directly without the involvement of ADCC and CDC. REGiMMUNE overcame the original bottleneck of protein production of the humanized IgG, developed a high yield method to manufacture it in mammalian cells. As MHC Class II molecules are found highly expressed on lymphoid malignant cells, and have been increasingly recognized to express highly in major solid cancer cells, AB08-H1 is expected to treat various types of lymphoid malignancies (Hodgkin and Non-Hodgkin lymphomas), and solid cancers.

REGiMMUNE is encouraged by the recent news of Nobel Prize in Physiology granted to Dr. Shimon Sakaguchi and others, for their works on Treg cells. We are pleased to see that the fundamental roles of Treg cells in autoimmune disease, GvHD, cancer, and infectious disease are recognized in highest profile. REGiMMUNE is committed to developing therapeutics with, as Dr. Shimon Sakaguchi well put it, Treg-up strategies vs Treg-down strategies.

(Press release, REGimmune, OCT 30, 2025, View Source [SID1234657165])

On October 30, 2025 Novocure (NASDAQ: NVCR) reported financial results for the third quarter that ended September 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).

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"Q3 was a solid quarter with steady commercial execution in glioblastoma, geographic expansion, and material progress for our clinical and product development pipelines," said Ashley Cordova, CEO, Novocure. "With four indications expected in market by year-end 2026, we are well on our way to becoming a platform therapy company — and we remain sharply focused on reaching profitability and expanding patient impact."

Financial updates for the third quarter ended September 30, 2025:

Total net revenues for the quarter were $167.2 million, an increase of 8% compared to the same period in 2024. This increase was primarily driven by active patient growth, as well as $3.3 million in exchange rate benefits.
The U.S., Germany, France and Japan contributed $96.6 million, $20.3 million, $19.6 million and $9.4 million, respectively, with other active markets contributing $15.7 million.
Revenue in Greater China from Novocure’s partnership with Zai Lab totaled $5.6 million.
Recognized revenue from Optune Lua in the quarter was $3.1 million, including $1.6 million from non-small cell lung cancer (NSCLC) and $1.5 million from malignant pleural mesothelioma (MPM).
Gross margin for the quarter was 73% compared to 77% in the prior year. The reduction was primarily driven by the continued roll out of our Head Flexible Electrode (HFE) transducer array for use with Optune Gio, costs associated with treating NSCLC patients prior to establishing broad reimbursement, and increased tariffs. Additionally, this quarter Novocure recognized a $2.9 million expense related to an inventory obsolescence provision for Optune Lua arrays.
Research, development and clinical study expenses for the quarter were $54.0 million, an increase of 4% from the same period in 2024. This was primarily driven by increased product development costs and increased regulatory expenses related to the premarket approval (PMA) applications for the use of TTFields therapy in the treatment of locally advanced pancreatic cancer and brain metastases from NSCLC.
Sales and marketing expenses for the quarter were $58.5 million, a decrease of 2% compared to the same period in 2024. This was primarily driven by lower share-based compensation expenses.
General and administrative expenses for the quarter were $45.9 million, an increase of 15% compared to the same period in 2024. This increase was primarily driven by higher share-based compensation expenses and higher personnel and professional services expenses to support the greater company build-out, particularly in enterprise technology as we invest in our digital infrastructure to enable scale.
Net loss for the quarter was $37.3 million with loss per share of $0.33.
Adjusted EBITDA* for the quarter was $(3.0) million.
Cash, cash equivalents and short-term investments were $1,033.5 million as of September 30, 2025.
Operational updates for the third quarter ended September 30, 2025:

As of September 30, 2025, there were 4,416 total active patients on TTFields therapy globally.
Optune Gio
1,675 prescriptions for Optune Gio for the treatment of glioblastoma were received in the quarter, an increase of 7% from the same period in 2024. The U.S., Germany, France and Japan contributed 954; 227; 191 and 130 prescriptions, respectively, with the remaining 173 prescriptions contributed by other active markets.
As of September 30, 2025, there were 4,277 Optune Gio active patients on therapy, an increase of 5% from the same period in 2024. The U.S., Germany, France and Japan contributed 2,176; 595; 499 and 474 Optune Gio active patients, respectively, with the remaining 533 active patients contributed by other active markets.
Optune Lua
130 total prescriptions for Optune Lua were received in the quarter. 109 Optune Lua prescriptions were received for the treatment of NSCLC and 21 prescriptions were received for the treatment of MPM.
As of September 30, 2025, there were 139 active Optune Lua patients on therapy, including 100 patients treated for metastatic NSCLC and 39 patients treated for MPM.
Quarterly updates and achievements:

In August 2025, Novocure’s PMA application to the U.S. Food and Drug Administration (FDA) for the use of TTFields therapy for the treatment of locally advanced pancreatic cancer was accepted for filing. This submission is supported by data from the Phase 3 PANOVA-3 trial, which evaluated the use of TTFields therapy concomitantly with gemcitabine and nab-paclitaxel as a first-line treatment for adults with unresectable, locally advanced pancreatic cancer.
In August 2025, Novocure announced the coverage of Optune Gio through the Spanish National Health System for the treatment of adult patients with newly diagnosed glioblastoma
In September 2025, Novocure received approval for Optune Lua use concurrently with PD-1/PD-L1 inhibitors in adult patients with unresectable advanced/recurrent NSCLC who progressed on or after platinum-based chemotherapy from the Japanese Ministry of Health, Labour and Welfare.
Anticipated clinical and regulatory milestones:

Novocure intends to submit 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 Q4 2025.
The topline data readout from the Phase 2 PANOVA-4 clinical trial in metastatic pancreatic cancer is expected in Q1 2026.
The topline data readout from the Phase 3 TRIDENT clinical trial in newly diagnosed glioblastoma is expected in Q2 2026.
Conference call details
Novocure will host a conference call and webcast to discuss third quarter 2025 financial results at 8:00 a.m. EDT today, Thursday, October 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 webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, 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.

(Press release, NovoCure, OCT 30, 2025, View Source [SID1234657183])