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Immunocore reports third quarter financial results and provides a business update

On November 6, 2025 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, reported its financial results for the third quarter ended September 30, 2025, and provided a business update.

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"Our commercial momentum continues with over $100 million in sales this quarter and enables sustained investment in innovation. We are executing to plan – advancing three Phase 3 melanoma trials and multiple mid-stage programs – to deliver transformative outcomes for patients and sustained value for shareholders," said Bahija Jallal, Chief Executive Officer of Immunocore.

Third Quarter 2025 Highlights (including post-period)

KIMMTRAK
The Company’s lead product, KIMMTRAK (tebentafusp), is approved in 39 countries and has been launched in 28 countries globally to date for HLA-A*02:01 positive people with unresectable or metastatic uveal melanoma (mUM). KIMMTRAK continues to be the standard of care in most markets where it is launched.

The Company sees three key growth areas as it plans to expand patient reach for KIMMTRAK, including continued global expansion in mUM, the potential expansion into 2L+ advanced cutaneous melanoma (CM), and the potential expansion into adjuvant uveal melanoma.

Metastatic uveal melanoma

KIMMTRAK net product sales were $103.7 million and $295.5 million for the three and nine months ended September 30, 2025, respectively, representing increases of 29% and 31% respectively, as compared to the same periods in 2024.
18% year-over-year quarterly sales growth in the United States with mean duration of treatment increasing to 14 months.
58% year-over-year quarterly sales growth in Europe and in international regions combined, driven by increased demand and launches in additional markets.
2L+ advanced cutaneous melanoma

The Company is currently enrolling patients in the TEBE-AM registrational Phase 3 trial and expects to complete enrollment in the first half of 2026.
The Phase 3 trial is enrolling three arms: tebentafusp monotherapy, tebentafusp in combination with pembrolizumab, and a control (investigator’s choice of therapy including clinical trials, chemotherapy, or retreatment with anti-PD1 or BRAF therapy). The primary endpoint of the randomized Phase 3 trial is Overall Survival (OS).
There is great unmet need in second- and later-line cutaneous melanoma, with no therapy having shown, to date, an OS improvement post checkpoint inhibitors in a randomized clinical trial. The Company estimates that there is a potential to address up to 4,000 previously treated advanced CM patients.

Adjuvant uveal (or ocular) melanoma

The European Organisation for Research and Treatment of Cancer (EORTC) continues to expand the site footprint of the Phase 3 Adjuvant Trial in Ocular Melanoma (ATOM).
The Company estimates that the HLA-A*02:01 positive, high-risk adjuvant uveal melanoma patient population could be up to 1,200 patients in the US and Europe.
PRAME portfolio
Brenetafusp is the Company’s lead PRAME-A02 ImmTAC bispecific candidate. Brenetafusp is being evaluated in combination with nivolumab in a Phase 3 registrational trial (PRISM-MEL-301) in patients with first-line, advanced cutaneous melanoma, and in a Phase 1/2 clinical trial as monotherapy and in combination across multiple tumor types, including ovarian cancer and non-small cell lung cancer (NSCLC).

PRISM-MEL-301 – First PRAME Phase 3 clinical trial with brenetafusp in first-line advanced cutaneous melanoma

The Independent Data Monitoring Committee (IDMC) has recommended the dose of 160 mcg as the go-forward dose in PRISM-MEL-301, the Company’s registrational Phase 3 trial in first-line, advanced cutaneous melanoma.
The IDMC made the decision following a pre-planned review of safety for all three arms and of efficacy for the two brenetafusp regimens (40 mcg and 160 mcg) in the first 90 patients randomized in the Phase 3 trial. (In 1Q 2025, the IDMC reviewed the safety of the first 30 patients randomized and recommended to continue the study with no changes.)
Patients treated with the dose of 160 mcg will be included in the intent-to-treat analysis for the primary endpoint.
Patients who are receiving 40 mcg have the option to dose-escalate to 160 mcg but will not be included in the intent-to-treat analysis for the primary endpoint.
The Company will now continue with a 1:1 randomization of HLA-A*02:01 positive patients with first-line, advanced or metastatic cutaneous melanoma to brenetafusp 160 mcg + nivolumab or a control arm of either nivolumab or nivolumab + relatlimab.
Despite approved therapies, there remains a need for improved progression-free survival and OS, and there is the potential to address an estimated 10,000 HLA-A*02:01 positive patients in the US and Europe.
Phase 1/2 clinical trial of brenetafusp in multiple solid tumors

The Company continues to evaluate brenetafusp in a Phase 1/2 trial in combination with non-platinum chemotherapies in platinum-resistant ovarian cancer (PROC) and with bevacizumab or with platinum chemotherapy in earlier lines of platinum-sensitive ovarian cancer (PSOC). In the same trial, the Company continues signal detection in metastatic non-small cell lung cancer (NSCLC) cohorts, including brenetafusp in combination with docetaxel and with osimertinib in earlier-line NSCLC.

IMC-P115C (PRAME-A02 Half-Life Extended) & IMC-T119C (PRAME-A24)

The Company is enrolling patients in the Phase 1 dose escalation trial evaluating IMC-P115C in patients with multiple solid tumors.

IMC-R117C (PIWIL1) for colorectal and other gastrointestinal cancers

The Company is enrolling patients in the Phase 1/2 dose escalation trial evaluating IMC-R117C in HLA-A*02:01 positive patients with advanced solid tumors, including colorectal cancer, as a single agent and in combination with standards of care.

ImmTAV candidates for a functional cure in infectious diseases
The Company’s bispecific TCR technology platform has the potential to offer a new approach for the treatment of certain chronic infections and aims to eliminate evidence of remaining virus in circulation after the patient stops taking medication – known as a ‘functional cure’. Two investigational candidates are in Phase 1 or Phase 1/2 trials for people living with human immunodeficiency virus (HIV) and people with chronic hepatitis B infection (HBV).

Phase 1/2 trial of IMC-M113V (Gag-A02) for people living with HIV

Patient enrollment continues at higher doses in the multiple ascending dose part of the Phase 1/2 clinical trial to identify a safe and tolerable dose.

Phase 1 trial of IMC-I109V (Envelope-A02) for people living with HBV or HBV-positive hepatocellular carcinoma

The Company will present the following poster at the 2025 American Association for the Study of Liver Diseases’ Meeting on November 7, 2025:
Title: IMC-I109V, a soluble T cell receptor (TCR) bispecific targeting HBsAg (ENVxCD3), is tolerable and active against hepatitis B in a first-in-human (FIH) single ascending dose (SAD) study (Poster 1185)
Presenting author: Man-Fung Yuen, MD, PhD, DSc
Session: Poster Session Hepatitis B ("1118-1367")
Date and time: Friday November 7, 2025; 8:00 a.m.-5 p.m. ET

Tissue-specific down modulation of the immune system for autoimmune diseases
The key differentiator of the ImmTAAI platform is tissue-specific, down modulation of the immune system, as the candidates suppress pathogenic T cells via PD1 receptor agonism only when tethered to the target tissue.

IMC-S118AI (PPI-A02) for type 1 diabetes

The Company is on track to file a clinical trial application (CTA) or investigational new drug application (IND) for IMC-S118AI (PPI x PD1) in the second half of 2025.

IMC-U120AI (CD1a) for atopic dermatitis as the initial indication – first universal program

The Company plans to file a CTA/IND for IMC-U120AI (CD1a x PD1) in 2026.

Financial Results
For the third quarter ended September 30, 2025, the Company generated net product sales of $103.7 million compared to $80.2 million for the same period in 2024. Sales of KIMMTRAK were $67.3 million in the United States, $33.5 million in Europe, and $2.9 million in the international regions. The increase in net product sales was due to increased volumes in the United States and Europe as well as global country expansion.

For the quarter ended September 30, 2025, research and development (R&D) expenses were $70.6 million compared to $52.8 million for the same period in 2024. The increase was due to preclinical expenses related to the advancement of the Company’s autoimmune programs, including clinical material manufacturing for anticipated Phase 1 initiations, and clinical expenses related to the progression of the Company’s Phase 3 trials, primarily TEBE-AM and PRISM-MEL-301.

For the quarter ended September 30, 2025, SG&A expenses were $39.8 million compared to $35.5 million for the same period in 2024. The increase was primarily due to costs related to business support functions to support the Company’s growing pipeline and global commercial expansion.

Net (loss) for the quarter ended September 30, 2025, was ($0.2) million, as compared to a net profit of $8.7 million for the same period in 2024. Basic and diluted net loss per share was ($0.00) for the quarter ended September 30, 2025, as compared to a basic and diluted net income per share of $0.17 for the same period in 2024.

Cash, cash equivalents and marketable securities were $892.4 million as of September 30, 2025, as compared to $820.4 million as of December 31, 2024. The Company expects to pay approximately $65 million in sales-related rebate accruals in the fourth quarter of 2025.

(Press release, Immunocore, NOV 6, 2025, View Source [SID1234659572])

Genmab Announces Financial Results for the Nine Months of 2025

On November 6, 2025 Genmab reported Interim results for the Nine Months ended September 30, 2025

Highlights

Announcement of Genmab’s proposed acquisition of Merus N.V. (Merus)
Genmab revenue increased 21% compared to the first nine months of 2024, to $2,662 million
FDA granted BTD to Rina-S in advanced endometrial cancer
Epcoritamab Phase 3 EPCORE FL-1 trial met dual primary endpoints of ORR and PFS, demonstrating statistically significant and clinically meaningful differences in both endpoints
FDA granted priority review of the sBLA for epcoritamab plus R2 in patients with relapsed or refractory FL

"In the third quarter we made advances that underscore the potential of our late-stage portfolio; Epcoritamab moved closer to being available to patients in earlier lines of therapy for follicular lymphoma and Rina-S was granted Breakthrough Therapy Designation (BTD) in advanced endometrial cancer. With robust development plans for both epcoritamab and Rina-S and with Tivdak (tisotumab vedotin) now available for prescribing in Germany – our first commercial entry into a European market – we continue to execute on our strategic imperatives to accelerate our late-stage pipeline and maximize our approved medicines to reach more patients," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "In addition, our proposed acquisition of Merus provides us with the potential to add petosemtamab, a late-stage asset with two BTDs, to our late-stage portfolio. This proposed transaction is expected to meaningfully accelerate our shift to a wholly owned model, driving sustained growth into the next decade and contributing to our evolution into a global biotechnology leader."

Financial Performance First Nine Months of 2025

Revenue was $2,662 million for the first nine months of 2025 compared to $2,198 million for the first nine months of 2024. The increase of $464 million, or 21%, was primarily driven by higher DARZALEX and Kesimpta royalties achieved under our collaborations with Johnson & Johnson (J&J) and Novartis Pharma AG (Novartis), respectively, and higher EPKINLY net product sales.
Royalty revenue was $2,219 million in the first nine months of 2025 compared to $1,802 million in the first nine months of 2024, an increase of $417 million, or 23%. The increase in royalties was driven by higher net sales of DARZALEX and Kesimpta.
Net sales of DARZALEX (daratumumab), including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO in the U.S.) by J&J were $10,448 million in the first nine months of 2025 compared to $8,586 million in the first nine months of 2024, an increase of $1,862 million or 22%.
Total costs and operating expenses were $1,655 million in the first nine months of 2025 compared to $1,536 million in the first nine months of 2024. The increase of $119 million, or 8%, was driven by the expansion of our product pipeline, including advancement of Rina-S, the continued development of Genmab’s broader organizational capabilities as well as profit-sharing amounts payable to AbbVie Inc. (AbbVie) related to EPKINLY sales.
Operating profit was $1,007 million in the first nine months of 2025 compared to $662 million in the first nine months of 2024.

Outlook
Genmab is maintaining its 2025 financial guidance published August 7, 2025.

Other Matters
Both the functional currency of the Genmab A/S legal entity and the presentation currency of the condensed consolidated financial statements have been changed from DKK to USD effective January 1, 2025. The change in functional currency has been implemented with prospective effect. The change in presentation currency has been implemented with retrospective effect. Comparative figures for prior periods have been restated accordingly.

As disclosed in Company Announcement No. 46, Genmab and Merus announced that the companies entered into a transaction agreement pursuant to which Genmab intends to acquire all the shares of Merus, a clinical-stage biotechnology company with its late-stage breakthrough therapy asset petosemtamab, which is in Phase 3 development, for USD 97.00 per share in an all-cash transaction representing a transaction value of approximately USD 8.0 billion. The transaction is not subject to a financing condition. Consideration is expected to be funded through a combination of cash on hand and approximately $5.5 billion of non-convertible debt financing. Genmab has obtained a funding commitment from Morgan Stanley Senior Funding, Inc. for this amount. The financing package includes a meaningful portion of prepayable debt, in line with Genmab’s commitment to deleveraging with a target of gross leverage <3x within two years after the closing of the proposed transaction. On October 21, 2025, a wholly owned subsidiary of Genmab commenced a tender offer for 100% of Merus’ common shares. The proposed transaction is anticipated to close by early in the first quarter of 2026, subject to the satisfaction of customary closing conditions for similar transactions. In addition to the Company Announcement, further information may be found in Notes 1 and 2, below.

Conference Call
Genmab will hold a conference call to discuss the results for the first nine months of 2025 today, Thursday, November 6, at 6:00 pm CET, 5:00 pm GMT or 12:00 pm EST. To join the call please use the below registration link. Registered participants will receive an email with a link to access dial-in information as well as a unique personal PIN: View Source A live and archived webcast of the call and relevant slides will be available at View Source

(Press release, Genmab, NOV 6, 2025, View Source [SID1234659571])

Galapagos Reports Nine Months 2025 Financial Results and Provides Business Update

On November 6, 2025 Galapagos NV (Euronext & Nasdaq: GLPG) reported its financial results for the first nine months of 2025, and provided a third quarter and recent business update.

"We successfully delivered on our commitment to define a clear path forward for Galapagos following the completion of the strategic review of our cell therapy business," said Henry Gosebruch, CEO of Galapagos. "We have built a team with world-class strategy and business development capabilities as we focus on disciplined capital stewardship and transformative business development, supporting a stronger and sustainable future for Galapagos."

Gosebruch added, "Looking ahead, we will seek to strategically deploy our capital in a disciplined manner by pursuing value-accretive transactions. Our business development team is actively evaluating a broader array of opportunities with priority given to promising small molecule and biologics programs with proof-of-concept in immunology and oncology and potential to deliver meaningful patient impact. We believe our partnership with Gilead can be a strategic advantage as we pursue these opportunities. We expect to focus on transactions that can deliver meaningful value to patients and shareholders while ensuring effective risk diversification."

"We ended the third quarter with a strong balance sheet that provides us with the flexibility to allocate capital strategically and invest in future business development opportunities," said Aaron Cox, CFO of Galapagos. "We expect to end the year with approximately €2.975 billion to €3.025 billion in cash and financial investments, excluding any business development activities and currency fluctuations. If the intention to wind down the cell therapy business is implemented and the process is completed, we would expect to be cash flow neutral to positive by the end of 2026, excluding any business development activities and currency fluctuations."

Third quarter 2025 and recent business update

Outcome of the Strategic Alternatives Process for Galapagos’ Cell Therapy Business

On October 21, 2025, Galapagos announced its intention to wind down its cell therapy business as part of the Company’s ongoing transformation. This intention is subject to the conclusion of consultations with works councils in Belgium and the Netherlands, during which Galapagos will continue to operate the business. Galapagos would consider any viable proposal to acquire all, or part of the cell therapy business, if such a proposal were to emerge during the wind down process.
If ultimately implemented, the wind down would impact approximately 365 employees across Europe, the U.S., and China, and would include the closure of sites in Leiden (the Netherlands), Basel (Switzerland), Princeton and Pittsburgh (U.S.), and Shanghai (China).
The remaining Galapagos organization is expected to be a lean organization of approximately 35-40 employees by the end of 2026, repositioned for long-term growth through transformational business development, while maintaining a dedicated presence at its headquarters in Mechelen, Belgium and its hub in Chicago, IL (U.S.).
Corporate

Senior leadership has been further strengthened with the appointment of Fred Blakeslee as Executive Vice President and General Counsel on October 16, and Sooin Kwon as Chief Business Officer and Dan Grossman as Chief Strategy Officer, effective August 4. These appointments have added strong corporate, business development and strategic assessment capabilities to the leadership team.
As part of the Company’s ongoing commitment to long-term governance and strategic continuity, several changes to the Board of Directors were announced:
Dawn Svoronos and Jane Griffiths were appointed by way of co-optation as Non-Executive Independent Directors, replacing Peter Guenter and Simon Sturge, effective July 28.
Dr. Neil Johnston has been appointed to the Board of Directors by way of co-optation as Non-Executive Independent Director, effective November 1. In addition, Devang Bhuva, current Senior Vice President of Corporate Development and Alliance Management at Gilead, has been appointed by way of co-optation as Non-Executive Non-Independent Director, effective November 1. In connection with these co-optations, Non-Executive Independent Directors Dr. Elisabeth Svanberg and Dr. Susanne Schaffert, and Non-Executive Non-Independent Director and current CFO of Gilead, Andrew Dickinson, stepped down, effective November 1. An additional Non-Executive Independent Director is expected to be appointed in the near future as part of the Board’s commitment to maintain a balanced, diversified Board composition with appropriate capabilities and profiles.
Clinical Pipeline
GLPG5101, a CD19 CAR-T candidate in Phase 1/2 across eight hematological malignancies

Two abstracts have been accepted for an oral and poster presentation at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, to be held in Orlando, from December 6-9.
In August, the FDA granted RMAT designation to GLPG5101 for the treatment of relapsed/refractory mantle cell lymphoma.
GLPG3667, a small molecule TYK2 inhibitor in two Phase 3-enabling studies in systemic lupus erythematosus (SLE) and dermatomyositis (DM)

Both the SLE and DM studies have progressed well, and topline data from both studies are expected in early 2026.
On October 26, Galapagos presented in vitro pharmacology data at the American College of Rheumatology (ACR) Convergence 2025, suggesting differentiation of GLPG3667 from other TYK2 inhibitors at their clinical dose regimens.
Financial performance

Key figures for the first nine months of 2025 (consolidated)
(€ millions, except basic & diluted earnings/loss (-) per share)

September 30, 2025 September 30, 2024 % Change
Supply revenues 29.3 19.1 +53%
Collaboration revenues 182.1 181.0 +1%
Total net revenues 211.4 200.1 +6%
Cost of sales (29.3) (19.1) +53%
R&D expenses (351.9) (238.2) +48%
G&Aiand S&Miiexpenses (109.0) (93.2) +17%
Impairment of the cell therapy business (204.8) -
Other operating result 21.4 24.8 -14%
Operatingloss (462.2) (125.6) +368%
Fair value adjustments and net exchange differences (50.5) 31.8
Net other financial result 30.4 71.7
Income taxes 19.3 1.7
Net loss from continuing operations (463.0) (20.4)
Net profit from discontinued operations, net of tax 1.7 69.2
Net profit/loss (-) of the period (461.3) 48.8
Basic and diluted earnings/loss (-) per share (€) (7.0) 0.7
Financial investments, cash & cash equivalents 3,050.1 3,338.8
Details of the financial results for the first nine months of 2025
Total operating loss from continuing operations for the first nine months of 2025, amounted to €462.2 million, compared to an operating loss of €125.6 million for the first nine months of 2024. This operating loss was negatively impacted by an impairment on the cell therapy business of €204.8 million as a result of the Company’s previously announced strategic alternatives process for the cell therapy business, and the executed strategic reorganization announced in January 2025, for €135.5 million. The latter is reflected in severance costs of €47.5 million, costs for early termination of collaborations of €45.5 million, impairment on fixed assets related to small molecules activities of €9.5 million, deal costs of €21.4 million, €9.8 million accelerated non-cash cost recognition for subscription right plans related to good leavers and €1.8 million other operating expenses.

Total net revenues amounted to €211.4 million for the first nine months of 2025, compared to €200.1 million for the first nine months of 2024. The revenue recognition related to the exclusive access rights granted to Gilead for Galapagos’ drug discovery platform amounted to €172.6 million for the first nine months, for both 2025 and 2024. The deferred income balance at September 30, 2025, includes €896.4 million allocated to the Company’s drug discovery platform. Royalties on Jyseleca from Gilead amounted to €8.3 million for the first nine months of 2025 (€8.4 million for the same period last year).
Cost of sales amounted to €29.3 million for the first nine months of 2025, compared to €19.1 million for the first nine months of 2024, and related to the supply of Jyseleca to Alfasigma under the transition agreement. The related revenues are reported in total net revenues.
R&D expenses amounted to €351.9 million for the first nine months of 2025, compared to €238.2 million for the first nine months of 2024. Increased personnel expenses (mainly related to severance costs), impairment on fixed assets (related to small molecules programs) and costs for early termination of collaboration agreements lead to this increase in R&D expenses.
S&M and G&A expenses amounted to €109.0 million for the first nine months of 2025, compared to €93.2 million for the first nine months of 2024. This increase was mainly due to higher personnel costs (primarily severance costs) and higher legal and professional fees (deal costs).
Impairment of cell therapy business is a result of the Company’s previously announced strategic alternatives process for the cell therapy business whereby the Company assessed the cell therapy business associated assets’ recoverable amount in accordance with IAS 36. The recoverable amount was estimated lower than the assets’ carrying value. As a result, the Company recognized an impairment loss of €204.8 million, thereby aligning the cell therapy assets’ book value with the Company’s strategic intention to wind down the cell therapy business, which resulted in a full impairment of both the associated goodwill and intangible assets and a partial impairment of property, plant and equipment.
Other operating result amounted to €21.4 million for the first nine months of 2025, compared to €24.8 million for the first nine months of 2024, mainly driven by lower grant and R&D incentives income and no recharges to Alfasigma.
Net financial loss amounted to €20.1 million for the first nine months of 2025, compared to net financial income of €103.5 million for the first nine months of 2024.

Fair value adjustments and net currency exchange results amounted to a negative amount of €50.5 million for the first nine months of 2025, compared to positive fair value adjustments and net currency exchange gains of €31.8 million for the first nine months of 2024, and were primarily attributable to €29.1 million of negative changes in fair value of financial investments, €44.0 million of unrealized currency exchange losses on our cash and cash equivalents and financial investments at amortized cost in U.S. dollars, partly offset by a positive effect of €22.7 million as consequence of the settlement of a hedging instrument.
Net other financial income amounted to €30.4 million for the first nine months of 2025, compared to net other financial income of €71.7 million for the first nine months of 2024. Interest income amounted to €31.4 million for the first nine months of 2025, compared to €70.6 million of interest income for the first nine months of 2024, due to a decrease in the interest rates and a shift from investments in term deposits generating financial income to investments in money market funds generating fair value changes. Fair value gains and interest income derived from cash, cash equivalents and financial investments excluding any currency exchange results amounted to €77.2 million for the first nine months of 2025 (compared to €108.9 million for the same period last year).
Income taxes amounted to €19.3 million for the first nine months of 2025. The increase is mainly explained by the reversal of the deferred tax liabilities linked to capitalized intangible assets related to the cell therapy business, as the Company recorded an impairment on these intangible assets.

The Company reported a net loss from continuing operations of €463.0 million for the first nine months of 2025, compared to a net loss from its continuing operations of €20.4 million for the first nine months of 2024.

Net profit from discontinued operations related to Jyseleca amounted to €1.7 million for the first nine months of 2025, compared to net profit amounting to €69.2 million for the first nine months of 2024. The net result for discontinued operations included €10.4 million of R&D expenses primarily related to the final settlement of disputed expenses with Alfasigma, and €11.4 million of other operating income related to a fair value adjustment of the contingent consideration receivable from Alfasigma as a consequence of an adjusted sales forecast. The operating profit from discontinued operations for the first nine months of 2024, was mainly related to the gain on the sale of the Jyseleca business to Alfasigma of €52.3 million.

Galapagos reported a net loss of €461.3 million for the first nine months of 2025, compared to a net profit of €48.8 million for the first nine months of 2024.

Cash position

Financial investments and cash and cash equivalents totaled €3,050.1 million on September 30, 2025, as compared to €3,317.8 million on December 31, 2024. The cash and cash equivalents and financial investments included $2,161.1 million held in U.S. dollars ($726.9 million on December 31, 2024) which could generate foreign exchange gains or losses in the financial results in accordance with the fluctuation of the EUR/U.S. dollar exchange rate as the Company’s functional currency is EUR (translated at a rate of 1.1741 €/$ at September 30, 2025).

Total net decrease in cash and cash equivalents and financial investments amounted to €267.7 million during the first nine months of 2025, compared to a net decrease of €345.7 million during the first nine months of 2024. This net decrease was composed of (i) €145.1 million of operational cash burn, which includes cash in of €77.7 million related to the return on financial investments) (ii) €118.6 million of negative exchange rate differences, positive changes in fair value of current financial investments, variation in accrued interest income, (iii) €20.0 million convertible loan issued to a third party, and (iv) €16.0 million of net cash is related to the sale of subsidiaries.

Financial guidance

Galapagos anticipates ending 2025 with approximately €2.975 billion to €3.025 billion in cash, cash equivalents and financial investments, excluding any business development activities and currency fluctuations. In the event that the Board would effectively proceed with a full wind down decision of the cell therapy business (i.e., if the intention is confirmed after works council processes), the Company would expect to incur the following spend related to the cell therapy business: €100 million to €125 million of operating cash impact from Q4 2025 through 2026 and €150 million to €200 million of one-time restructuring cash impact in 2026. If the intention to wind down is implemented and the process is completed, the Company would expect to be cash flow neutral to positive by the end of 2026, excluding any business development activities and currency fluctuations.

Conference call for investors and analysts

Galapagos will host a conference call on November 6, 2025, at 14:00 CET / 08:00 AM ET, during which the company will also share further details on its business development strategy. To participate, please register using this link. Dial-in details will be provided upon registration. Participants can join the call 10 minutes before the start time using the access information received by email or via the "call me" feature. The live call and presentation will be available on glpg.com or via the following link. A replay and related materials will be available shortly after the call in the investors section of the website.

(Press release, Galapagos, NOV 6, 2025, View Source [SID1234659570])

Exelixis to Webcast Fireside Chats as Part of Upcoming Investor Conferences in November

On November 6, 2025 Exelixis, Inc. (Nasdaq: EXEL) reported that company management will participate in fireside chats at the following investor conferences in November:

Guggenheim 2nd Annual Healthcare Innovation Conference: Exelixis is scheduled to present at 10:30 a.m. ET / 7:30 a.m. PT on Monday, November 10 in Boston.
Stifel 2025 Healthcare Conference: Exelixis is scheduled to present at 8:40 a.m. ET / 5:40 a.m. PT on Tuesday, November 11 in New York City.

To access the webcast links, log onto www.exelixis.com and proceed to the Event Calendar page under the Investors & News heading. Replays will also be available at the same location for at least 30 days.

(Press release, Exelixis, NOV 6, 2025, View Source [SID1234659569])

Evaxion announces business update and third quarter 2025 financial results

On November 6, 2025 Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported business update and announces third quarter 2025 financial results.

Business highlights (since last quarterly update)
Evaxion has seen tremendous progress in recent months with several massive achievements. We maintain a high activity level and continue to execute our plans. Highlights include:

Evaxion’s Board of Directors has appointed Dr Helen Tayton-Martin as new CEO, effective November 24, 2025. Dr Tayton-Martin brings more than 30 years of experience, including biotech M&A, business development and operations.
Unprecedented data from the phase 2 trial with personalized cancer vaccine EVX-01 in advanced melanoma patients presented on stage at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, one of the most prestigious medical oncology conferences in the world.
We continue to enhance and expand our AI-Immunology platform, most recently with the addition of an automated vaccine design module replacing previous manual vaccine design processes.
EVX-B3, the bacterial vaccine candidate now out-licensed to MSD (tradename of Merck & Co., Inc., Rahway, NJ, USA), was discovered with AI-Immunology, making it the first AI-designed vaccine candidate ever to be licensed by a pharmaceutical company. We have received $7.5 million in option exercise fee and will be eligible for future payments of up to $592 million.
Evaxion’s cash runway has been extended to the second half of 2027 from previously first half of 2027 following the payment from MSD and cash raised from capital market activities in September and October totaling $7.2 million.

"We are really pleased with our achievements in recent months which have validated both our technology and strategy as well as significantly strengthened our position for future value creation. The impressive EVX-01 data shows our capabilities in cancer vaccines and the out-licensing of EVX-B3 confirms them in infectious disease vaccines. This is very important as we maintain a number of partnership discussions across disease areas and our AI-Immunology platform," says Birgitte Rønø, CSO and interim CEO of Evaxion.

Conference call and webcast
Evaxion’s Executive Management will host a conference call and webcast at 8.30 ET/14.30 CET today, presenting the business update and financial results as well as taking questions. This event is free, open to the public and encouraged.

To join the conference call, listen to the presentation and ask verbal questions, please register in advance via this link to receive the dial-in telephone numbers and a unique PIN code. The call can be accessed 15 minutes prior to the start of the live event.

To join the webcast, please click on this link. The webcast recording will be available on our website shortly after the event.

Research & Development (R&D) update
Evaxion has a R&D pipeline of innovative vaccine candidates for both cancer and infectious diseases.

Our lead asset is the personalized cancer vaccine EVX-01. Developed with AI-Immunology, it is designed to target multiple neoantigens; cancer unique proteins arising from mutations. We have now completed the initially planned two-years of treatment in the phase 2 trial with EVX-01 in patients with advanced melanoma (skin cancer) with very encouraging results.

The two-year data demonstrated an Objective Response Rate (ORR) of 75% as 12 out of 16 patients had objective clinical responses, with four patients obtaining a complete response. The ORR is even higher than the 69% observed after one year of treatment. Additionally, a durable clinical benefit was observed as 92% of patients were still responding at two years follow-up and no relapses were observed.

54% of patients had a deepened response during treatment, improving from stable disease or partial response to partial or complete response. Tumor reduction (target lesions) was observed in 15 out of the 16 patients enrolled in the trial.

In the trial, EVX-01 induced an immune response in all patients, with 81% of the targeted neoantigens generating potent specific T-cell responses. This high immunogenicity rate stands out as highly encouraging compared to historical observations and compares very favorably to what is seen with other approaches. These results also underline and validate the precision of the AI-Immunology platform in accurately identifying neoantigens, which leads to detectable signals in patients.

Data also confirmed EVX-01 to be a well-tolerated treatment. All in all, the data clearly supports further clinical development of EVX-01, for which we are actively looking for a partner. The phase 2 trial goes on with a one-year extension for a subset of patients to further strengthen EVX-01’s already encouraging data package.

The data was presented in an oral presentation at the ESMO (Free ESMO Whitepaper) conference, a strong testament to the interest in EVX-01 and the field of personalized cancer vaccines in general. We were present throughout the conference to interact and discuss with all interested stakeholders, including potential business partners.

We have recently expanded our pipeline with EVX-04, a novel vaccine candidate targeting multiple non-conventional ERV tumor antigens, developed with AI-Immunology. We will pursue clinical development of EVX-04, currently in preclinical development, as a new therapeutic vaccine against acute myeloid leukemia (AML).

EVX-04 is designed to target non-conventional ERV (endogenous retrovirus) tumor antigens from the dark genome. These antigens are present in tumors but absent in normal tissue, making them highly attractive targets for cancer vaccines.

Leveraging our proprietary AI-Immunology platform, Evaxion has identified ERV antigens in patient tumor sequencing data. Uniquely, the platform then selects optimal fragments from these antigens based on their potential to be effective vaccine targets across a wide range of patients.

By including multiple of these fragments in EVX-04, the vaccine is designed to be effective in all patients regardless of immune and tumor ERV antigen differences. This makes EVX-04 a so-called off-the-shelf vaccine preproduced and ready for immediate administration after diagnosis.

Data generated in the EVX-02 program has actively informed the development of both EVX-04 and EVX-03. As a matter of portfolio management, the EVX-02 program is now inactivated and removed from our R&D pipeline.

Further to the advancement of our R&D pipeline, the continued development and improvement of AI-Immunology is also an important part of our R&D work. Most recently, we have developed an automated vaccine design module replacing previous manual vaccine design processes. Thus, AI-Immunology, already superior in vaccine target discovery, now also enables enhanced design applicable for both new vaccines and optimization of approved ones.

Automated design can both improve the quality of the vaccines and shorten the design time compared to manual methods from months to days, also carrying significant cost savings.
The new module offers solutions for common problems encountered with traditional manual design methods, namely ensuring that vaccine targets can be properly expressed and obtained in the correct conformations.

The new design module can be applied to new as well as existing vaccines thereby potentially enabling the development of new and improved generations of vaccines already in use.

Further to our clinical progress, we also maintain a high level of preclinical activity with a number of active preclinical programs. Following the out-licensing of EVX-B3, the further development of this vaccine candidate is now in the hands of MSD and therefore removed from our R&D pipeline.

We maintain the ambition of replenishing the pipeline with another infectious disease vaccine candidate, having already added EVX-B4 earlier this year. However, our priority will be to do this as part of a target discovery collaboration with an external partner.

Business development update
We were delighted by the out-licensing of EVX-B3, which validates Evaxion, the platform and our pipeline as well as our strategy for long-term value creation and monetization of our assets. We have received $7.5 million in option exercise fee and will be eligible for future payments of up to $592 million.

MSD also holds an option to license EVX-B2, our Gonorrhea vaccine candidate. In September 2025 it was agreed to extend the evaluation period for EVX-B2. The extension follows an expansion of the initial evaluation plan encompassing further experiments. Consequently, a decision on potential in-licensing of EVX-B2 by MSD is now expected in the first half of 2026.

Should MSD exercise the option on EVX-B2, we will receive a cash payment of $2.5 million and be eligible for future development, regulatory and sales milestone payments of up to $592 million as well as royalties on sales as for EVX-B3. The milestones are not additive per product to get to total deal value as some discount may occur if both programs progress successfully.

We remain active in several parallel partnership discussions based on external interest in both our platform and pipeline as we continue to pursue our strategy of monetizing value through multiple partnerships. As has been the case throughout 2025, turmoil in financial markets and regulatory uncertainty impacts the decision processes with some potential partners, prolonging some discussions. Having concluded the deal on EVX-B3, we maintain the ambition of entering at least one more partnership deal in the coming months, even if uncertainty of timing is increasing.

Cash runway extended
On October 30, 2025, we announced the successful completion of different capital market activities, raising a gross total of $7.2 million. As a result, we now have cash on hand to fund our operations and R&D programs into the second half of 2027, extended from first half of 2027.

The proceeds strengthened both Evaxion’s cash position and equity and followed the influx of $7.5 million paid by MSD when licensing EVX-B3.

Of the $7.2 million, $4.5 million came from sales of shares in an at-the-market (ATM) offering and $2.7 million came from exercise of investor warrants. The latter 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.

Third quarter 2025 financial results
The third quarter showed strong financial performance with net income of $4.6 million, driven by revenue income from MSD’s option exercise and financial income from an 89% share price premium of the European Investment Bank’s (EIB’s) debt-to-equity conversion. The third quarter net income is a significant improvement compared to a net loss of $1.9 million for the same period 2024.

Revenue of $7.5 million for the quarter ending September 30, 2025, primarily relates to MSD option exercise and also includes revenue recorded from Gates Foundation. With the out-licensing of EVX-B3 to MSD, all future development cost of the program will be carried by MSD, while the deal will provide Evaxion with future revenue income potential of up to $592 million through milestone payments.

Research and development (R&D) expenses were $3.1 million for the period ending September 30, 2025, compared to $2.6 million last year. Project costs are more back-end loaded in 2025 compared to 2024, and overall, our expenses are well managed and within targets for the year.

General and administrative expenses were $1.4 million for the third quarter 2025, compared to $2.1 million in 2024. The decrease is primarily driven by lower capital market transaction costs.

Net financial income of $1.3 million is driven by $2.7 million financial income mainly due to the 89% share price premium from the EIB debt-to-equity conversion in July 2025, and $1.4 million financial expense mainly due to remeasurement of the derivative liability from investor warrants from our January 2025 public offering.

During the third quarter of 2025 we continued strong execution of our financial strategy, resulting in improved equity, lower leverage and extended cash runway. Our cash runway has now been extended to second half of 2027, improved from earlier first half of 2027.

Cash and cash equivalents as of September 30, 2025, were $10.6 million, compared to $6.0 million as of December 31, 2024. January to October 2025, we have received proceeds from capital market activity and recorded income of total $31.8 million, providing a significant improvement in our cash position.

Total equity amounts to $16.6 million as of September 30, 2025, which is a significant improvement compared to a negative equity of $(1.7) million as of December 31, 2024.

The equity is negatively impacted by $1.5 million as of September 30, 2025, arising from the net effect of the derivative liability from investor warrants issued as part of our January 2025 public offering. According to IAS/IFRS, the investor warrants are seen as derivative instruments, as the exercise price is denominated in USD while our company’s functional currency is DKK. Part of the proceeds from capital raises are consequently recognized as derivative liabilities. Reassessments are disclosed as financial income/expense and reverted to equity when warrants are exercised or lapse. The derivative liability from investor warrants has no impact on other items in the financial statement, hence Evaxion discloses the impact as a separate equity item. With the investor warrants exercised during October 2025, the net impact is expected to be reduced to a nominal impact by year end 2025.

Evaxion’s equity and market capitalization remain well above Nasdaq’s requirements, with ample headroom expected to persist, as we continue to execute our financial strategy.

Further, we will continue to focus and maintain our strict cost control and diligently prioritize and optimize our resource allocation. This enables us to absorb the general cost increase and inflation within the same cash spend as in 2024, e.g. we expect an operational cash burn of approximately $14 million in 2025.

(Press release, Evaxion Biotech, NOV 6, 2025, View Source [SID1234659568])