1stOncology™: Cancer Intelligence Service – Page 59 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Takeda Reports First Half FY2025 Results, with Business Fundamentals Tracking as Planned. Updates Full Year Outlook to Reflect FX Impact and Pipeline Impairment. On Track for Multiple Regulatory Filings This Fiscal Year

On October 30, 2025 Takeda (TOKYO:4502/NYSE:TAK) reported earnings results for the first half of fiscal year 2025 (six months ended Sep 30, 2025) and updated its full-year outlook.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

Takeda chief executive officer, Christophe Weber, commented:
"Takeda’s fiscal year 2025 first half results are consistent with our expectations for core business progress in this year of transition to a new phase focusing on new product launches. Our updated full-year outlook reflects impairment charges associated with strategic pipeline decisions taken in Q2, as well as transactional FX.

"Looking ahead, our current Growth and Launch Products portfolio will continue to generate moderate growth, which will accelerate in the future with new launches. We see FY2025 as a pivotal year for Takeda with regulatory filings for rusfertide and oveporexton expected in the second half of the year, as well as Phase 3 results for zasocitinib. We continue to expand our external partnerships to enhance the depth and breadth of our R&D pipeline and recently announced a global strategic partnership with Innovent Biologics to further strengthen our position in oncology.

"With this momentum in our pipeline, we’re confident in Takeda’s ability to deliver life-transforming treatments and long-term value for patients and shareholders, and we’re excited for the future."

Takeda chief financial officer, Milano Furuta, commented:
"Our financial results for the first half of FY2025 were driven by year-over-year impact from generic erosion of VYVANSE, as anticipated. In the second half, we expect this generic erosion impact to moderate and Growth and Launch Product growth to increase. Our updated outlook for the full year reflects the effects of transactional FX fluctuations and impairment losses on intangible assets associated with the gamma delta T-cell therapy platform—with strong OPEX management offsetting changes in product mix.

"We are confident in our business fundamentals as we look to the second half of this transitional year for Takeda."

FINANCIAL HIGHLIGHTS for FY2025 H1 Ended September 30, 2025

(Billion yen, except percentages and per share amounts)

FY2025 H1

FY2024 H1

vs. PRIOR YEAR

(Actual % change)

Revenue

2,219.5

2,384.0

-6.9%

Operating Profit

253.6

350.6

-27.7%

Net Profit

112.4

187.3

-40.0%

EPS (Yen)

119

-39.8%

Operating Cash Flow

593.7

451.3

+31.6%

Adjusted Free Cash Flow (Non-IFRS)

525.4

247.5

+112.3%

Core (Non-IFRS)

(Billion yen, except percentages and per share amounts)

FY2025 H1

FY2024 H1

vs. PRIOR YEAR

(Actual % change)

vs. PRIOR YEAR

(CER % change)

Revenue

2,219.5

2,384.0

-6.9%

-3.9%

Operating Profit

639.2

719.9

-11.2 %

-8.8%

Margin

28.8%

30.2%

-1.4 pp

―

Net Profit

438.6

489.1

-10.3%

-11.1%

EPS (Yen)

279

310

-10.0%

-10.8%

FY2025 Outlook

Updating Full Year Management Guidance, and Reported and Core Forecasts

Takeda has updated its full year outlook to reflect foreign exchange impacts and impairment charges related to the cell therapy platform.

FY2025 Management Guidance Core Change at CER (Non-IFRS)

FY2025 ORIGINAL MANAGEMENT GUIDANCE
(May 2025)

FY2025 REVISED MANAGEMENT GUIDANCE
(October 2025)

Core Revenue

Broadly flat

Core Operating Profit

Broadly flat

Low-single-digit % decline

Core EPS (Yen)

Broadly flat

Low-single-digit % decline

FY2025 Reported and Core Forecasts

(Billion yen, except percentages and per share amounts)

FY2025
ORIGINAL FORECAST

(May 2025)

FY2025

REVISED FORECAST

(October 2025)

Revenue

4,530.0

4,500.0

Core Revenue (Non-IFRS)

4,530.0

4,500.0

Operating Profit

475.0

400.0

Core Operating Profit (Non-IFRS)

1,140.0

1,130.0

Net Profit

228.0

153.0

EPS (Yen)

145

Core EPS (Yen) (Non-IFRS)

485

479

Adjusted Free Cash Flow (Non-IFRS)

750.0-850.0

600.0-700.0

Annual Dividend per Share (Yen)

200

Additional Information About Takeda’s FY2025 H1 Results
For more details about Takeda’s FY2025 H1 results, commercial progress, pipeline updates and other financial information, including key assumptions in the FY2025 forecast and management guidance as well as definitions of non-IFRS measures, please refer to Takeda’s FY2025 H1 investor presentation (available at View Source).

(Press release, Takeda, OCT 30, 2025, View Source [SID1234657185])

Tubulis Announces Second Closing of Series C Bringing Total Raised to €344M (US $401M)

On October 30, 2025 Tubulis reported a second and final closing of its Series C round totaling €344M (US $401M). The second closing brought in additional new investors Fidelity Management & Research Company, Janus Henderson Investors and Blackstone Multi-Asset Investing to a syndicate led by Venrock Healthcare Capital Partners with participation from additional new investors Wellington Management and Ascenta Capital. Existing investors who supported the Series C include Nextech Invest, EQT Life Sciences, Frazier Life Sciences, Andera Partners, Deep Track Capital, Bayern Kapital, Fund+, High-Tech Gründerfonds (HTGF), OCCIDENT, and Seventure Partners.

The additional funds will enable the company to further accelerate its plans to initiate pivotal trials with lead antibody-drug conjugate (ADC) candidate TUB-040, explore earlier lines of treatment in ovarian cancer, and expand into combination regimens and new solid tumor indications. The combined capital will advance Tubulis’ pipeline, including the clinical-stage ADC candidate TUB-030, and several preclinical programs. In addition, it will allow Tubulis to stay at the forefront of innovation with its proprietary ADC platform technologies to access novel applications and further optimize the ADC modality.

"We are expanding our syndicate with prestigious investors who all have significant track-records and a strategic long-term focus. The combined group of funds enables us to accelerate our clinical development plans and further expand our global footprint," said Dr. Dominik Schumacher, Chief Executive Officer and Co-founder of Tubulis. "We are now in a strong position to deliver on our goal – realizing the full potential of the ADC drug class for more patients."

Tubulis recently provided first positive early clinical data from its NAPISTAR1-01 Phase I/IIa study (NCT06303505) in a late-breaking oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 in Berlin, Germany. The results from the company’s lead ADC, TUB-040, in platinum-resistant high-grade serous ovarian cancer (PROC-HGSOC) validated Tubulis’ proprietary Tubutecan technology and established clear proof of concept for the company’s most advanced ADC targeting NaPi2b. TUB-040 showed a highly differentiated clinical profile in the ADC field, with anti-tumor activity beginning at low doses with a broad therapeutic window and a good safety and tolerability profile.

(Press release, Tubulis, OCT 30, 2025, View Source [SID1234657184])

Novocure Reports Third Quarter 2025 Financial Results

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).

"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])

Forlong Biotechology to Present Clinical Data from FL115, a novel interleukin-15 (IL-15) superagonist, in Late-breaking Session at 40th SITC Annual Meeting

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.

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])

Debiopharm Forges AI-powered Alliance With NetTargets to Pioneer Dual-payload ADCs Against Drug-resistant Cancers

On October 30, 2025 Debiopharm (www.debiopharm.com), a privately-owned, Swiss-based, biopharmaceutical company dedicated to developing innovative therapies that respond to high unmet medical needs, reported a strategic research collaboration with NetTargets (www.net-targets.com), a South Korean biotech company specializing in AI-enhanced systems biology for drug discovery, to rationally design and advance the discovery of novel, synergistic drug combinations for Debiopharm’s next-generation Antibody-Drug Conjugates (ADCs). This alliance unites NetTargets’ sophisticated artificial intelligence (AI) platform with Debiopharm’s proprietary MLINK technology to create a new paradigm in cancer treatment, aiming to deliver a decisive, dual-action blow against treatment-resistant tumors.

This collaboration achieves this multi-pronged strategy by uniting two cutting-edge technologies: NetTargets’ AI-Powered Discovery Engine and Debiopharm’s MLINK Duo Technology. NetTargets’ proprietary AI platform integrates multi-omics data with deep neural network modeling to uncover synergistic mechanisms and accelerate drug discovery. It sifts through millions of potential compound combinations to identify synergistic pairings—"one-two punches"—that are significantly more potent together than the sum of their individual effects. These AI-identified payloads will then be integrated into Debiopharm’s innovative ADC technologies using MLINK Duo, a proprietary linker engineered specifically to carry two distinct payloads on a single antibody. This precision bio-engineering ensures the coordinated delivery and release of both warheads directly inside the cancer cell, maximizing their synergistic impact while minimizing systemic toxicity. This combination of AI-driven discovery and precision bio-engineering promises to produce a pipeline of dual-payload ADCs with a higher probability of clinical success against the most challenging cancers.

"To address the fundamental challenge of therapeutic resistance, we are moving beyond single-agent attacks," explained Frédéric Lévy, Chief Scientific Officer at Debiopharm. "Our collaboration with NetTargets is about creating smarter and more precise therapies. We are using their powerful AI to find synergistic drug combinations for our ADC platforms, which allows us to rationally design therapies that are more effective. By attacking cancer on multiple fronts simultaneously, we not only increase the immediate efficacy of the treatment but also strategically minimize the cancer’s chances to adapt and develop resistance."

Debiopharm is advancing its ADC platform with a focus on proprietary bispecific ADCs and innovative payloads. By leveraging its proven drug development expertise, the company aims to accelerate next-generation ADC therapies to patients, addressing critical unmet medical needs.

"Our AI models are built to understand the complex biological networks that drive cancer," commented Dr. Je-Hoon Song, CEO of NetTargets. "By simulating how different drug mechanisms interact, we can pinpoint unique vulnerabilities that would be impossible to find through traditional screening. Partnering with Debiopharm, a leader in ADC technology, allows us to translate these digital discoveries into tangible, life-saving therapies."

MLINK Duo

MLINK Duo is a cleavable linker (part of the proprietary MultiLINK ADC Technology Suite – a modular, peptide-based, cathepsin B-cleavable linker platform) tailored for simultaneous attachment of two distinct payloads on a single antibody. MLINK Duo supports the production of ADCs with a high drug-to-antibody ratio (DAR) up to DAR8+8 and is compatible with various conjugation technologies. This unique and innovative technology ensures the coordinated delivery and release of both warheads directly inside the cancer cell, maximizing their synergistic impact while minimizing systemic toxicity, making it ideally suited for the AI-identified synergistic combinations.

(Press release, Debiopharm, OCT 30, 2025, View Source [SID1234657181])