Lyell Immunopharma Reports Business Highlights and Financial Results for the First Quarter 2026

On May 6, 2026 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, reported financial results and business highlights for the first quarter ended March 31, 2026.

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First Quarter Updates and Recent Business Highlights

Ronde-cel: A next-generation dual-targeting CD19/CD20 CAR T-cell product candidate designed to increase complete response rates and prolong the duration of response as compared to approved CD19‑targeted CAR T-cell therapies for the treatment of large B-cell lymphoma (LBCL)

Ronde-cel is an autologous CAR T-cell product candidate with a true ‘OR’ logic gate to target B cells that express either CD19 or CD20 with full potency and is manufactured with a process that enriches for CD62L-positive cells to generate more naïve and central memory CAR T cells with enhanced stemlike features and antitumor activity. The U.S. Food and Drug Administration (FDA) has granted ronde-cel Regenerative Medicine Advanced Therapy (RMAT) designation in the third- and later-line (3L+) and second-line (2L) settings, as well as Fast Track designation for the treatment of adults with relapsed/refractory large B-cell lymphoma (R/R LBCL). Two pivotal trials for ronde-cel in LBCL are underway.

The ongoing PiNACLE pivotal single-arm trial, a seamless expansion of the 3L+ cohort in the Phase 1/2 multi‑cohort trial, is ongoing. Additional data from this trial are expected in the second half of 2026, and pivotal data are expected in mid-2027 with submission of a Biologics License Application (BLA) to the FDA expected to follow in 2027. The primary endpoint of the trial is the overall response rate, including an evaluation of duration of response.
In February 2026, patient dosing commenced in PiNACLE-H2H, the first-of-its-kind Phase 3 randomized controlled trial evaluating ronde-cel versus investigator’s choice of axicabtagene ciloleucel or lisocabtagene maraleucel in patients with R/R LBCL in the 2L setting. The trial’s primary endpoint is event-free survival.

LYL273: A next-generation guanylyl cyclase C (GCC)-targeted CAR T-cell product candidate for the treatment of metastatic colorectal cancer (mCRC) and other GCC-expressing cancers

LYL273 is a GCC-targeted CAR T-cell product candidate enhanced with CD19 CAR expression and controlled cytokine release, designed to improve CAR T-cell expansion, immune cell infiltration and cancer cell killing in the hostile solid tumor microenvironment. In November 2025, Lyell acquired global rights (excluding mainland China, Hong Kong, Macau and Taiwan) to LYL273, which has shown promising dose-dependent clinical activity in patients with advanced mCRC in a Phase 1 trial conducted in the U.S. following proof of concept in 15 patients in China. The FDA granted LYL273 Fast Track designation for the treatment of mCRC.

The U.S. Phase 1 clinical trial is continuing to enroll patients to determine the recommended Phase 2 dose. In March 2026, dosing commenced at Dose Level 3 (3 x 106 CAR T cells/kg). A data update focused on safety from this trial is expected in the first half of 2026, with a second data update including clinical outcomes expected in the second half of 2026.

Additional Business Highlights

In March 2026, Lyell closed the second $50 million tranche of its July 2025 equity private placement, following the successful achievement of a clinical milestone in PiNACLE. In the second tranche of the financing, which completed the total $100 million private placement, shares of common stock were sold at a purchase price of $25.61 per share.
In March 2026, Smital Shah was appointed Chief Financial and Business Officer.

First Quarter 2026 Financial Results

Lyell reported a net loss of $24.2 million for the first quarter ended March 31, 2026, compared to a net loss of $52.2 million for the same period in 2025. The $28.0 million decrease in net loss was primarily due to a $17.6 million gain on our Securities Purchase Agreement put/call asset relating to our July 2025 equity private placement. Non‑GAAP net loss, which excludes non-cash stock-based compensation, non-cash expenses related to the change in the estimated fair value of the Securities Purchase Agreement put/call asset and success payment liabilities, decreased by $8.5 million to $37.8 million for the first quarter ended March 31, 2026, compared to $46.3 million for the same period in 2025 primarily due to the decreased headcount from the successful technology transfer of ronde-cel to the Company’s LyFE Manufacturing CenterTM (LyFE) in 2025.

GAAP and Non-GAAP Operating Expenses

Research and development (R&D) expenses were $36.6 million for the first quarter ended March 31, 2026, compared to $43.4 million for the same period in 2025. The $6.8 million decrease was primarily due to a $7.5 million reduction in personnel expenses, partially offset by a $3.4 million increase in clinical trials activity and outside services. Non‑GAAP R&D expenses, which exclude non-cash stock-based compensation, for the first quarter ended March 31, 2026 were $34.4 million compared to $41.1 million for the same period in 2025.
General and administrative (G&A) expenses were $9.6 million for the first quarter ended March 31, 2026 compared to $14.0 million for the same period in 2025. The $4.5 million decrease was primarily due to a $4.0 million reduction in personnel‑related expenses, including a $1.5 million decrease in stock-based compensation expense. Non‑GAAP G&A expenses, which exclude non-cash stock‑based compensation, for the first quarter ended March 31, 2026 were $7.5 million compared to $10.4 million for the same period in 2025.

A discussion of non-GAAP financial measures, including reconciliations of the most comparable U.S. generally accepted accounting principles (GAAP) measures to non‑GAAP financial measures, is presented below under "Non-GAAP Financial Measures."

Cash, cash equivalents and marketable securities

Cash, cash equivalents and marketable securities as of March 31, 2026 were $261.0 million compared to $247.2 million as of December 31, 2025. Lyell believes that its current cash, cash equivalents and marketable securities balances will be sufficient to meet working capital and capital expenditure needs into the third quarter of 2027.

(Press release, Lyell Immunopharma, MAY 6, 2026, View Source [SID1234665191])

Kura Oncology to Participate in Bank of America Securities Healthcare Conference

On May 6, 2026 Kura Oncology, Inc. (Nasdaq: KURA), a biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported its participation in the Bank of America Securities 2026 Healthcare Conference. Kura management is scheduled to participate in a fireside chat at 6:00 p.m. ET / 3:00 p.m. PT on May 13, 2026.

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The live webcast and archived replay of the event may be accessed on the Investors section of the Company’s website at www.kuraoncology.com.

(Press release, Kura Oncology, MAY 6, 2026, View Source [SID1234665190])

IN8bio to Showcase Next-Generation T Cell Engager Platform and New Clinical Data at Upcoming R&D Day and Medical Conferences

On May 6, 2026 IN8bio, Inc. (Nasdaq: INAB) ("IN8bio" or the "Company"), a clinical-stage biopharmaceutical company developing innovative gamma-delta ("γδ") T cell therapies for cancer and autoimmune diseases, reported a series of presentations at leading medical and scientific conferences in May and June 2026, including new clinical data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. IN8bio will also host a Research and Development (R&D) Day on May 21, 2026, showcasing advances across its γδ T cell pipeline, including its novel T cell engager (TCE) and clinical γδ T cell therapy programs.

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"We look forward to sharing progress across our γδ T cell platforms at our R&D Day and several key meetings this quarter," said William Ho, Chief Executive Officer and Co-Founder of IN8bio. "These presentations highlight the progress we are making with our novel TCE program, complemented by translational advances in our clinical program supporting the observed survival benefits in DeltEx DRI treated glioblastoma (GBM) patients. The unique properties of γδ T cells enable them to address key challenges in TCE development and to meaningfully improve outcomes in difficult-to-treat cancers."

Presentation details are outlined below:

IN8bio 2026 R&D Day (New York, New York)
In-person and Virtual

Featuring presentations on our T cell engager (TCE) platform for autoimmune diseases and our clinical program in GBM, with a clinical perspective from renowned neuro-oncologist Dr. David Reardon, Director of the Center for Neuro-Oncology at the Dana-Farber Cancer Institute and Professor of Medicine at Harvard Medical School.
Date and Time: May 21, 2026, 9:00 AM to 11:30 AM EDT
Register Online: View Source

International Society for Cell & Gene Therapy (ISCT) 2026 Annual Meeting (Dublin, Ireland)
Poster Presentations

Title: Unraveling Complexity: The Impact, Interactions and Outcomes of a γδ T Cell Therapy in Glioblastoma
Poster Details: 1253
Presenter: Mariska ter Haak
Date/Time: May 7, 2026, 18:00 to 19:30 GMT (1:00 PM to 2:30 PM EDT)
Title: Lean Infrastructure for CGT Early-Stage Companies: Leveraging Integrated Digital Platforms to Achieve Sustainable Operation Efficiency and Scalable Compliance
Poster Details: 801
Presenter: Guoling Chen
Date/Time: May 7, 2026, 18:00 to 19:30 GMT (1:00 PM to 2:30 PM EDT)
American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2026 Annual Meeting (Boston, MA)
Oral Presentation

Title: Challenging the Glioblastoma Status Quo: Could γδ T Cells Shift the Balance?
Abstract: 328
Presenter: Mariska ter Haak
Date and Time: May 14, 2026, 11:00 AM to 11:15 AM EDT
2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Chicago, IL)
Poster Presentation

Title: INB-200: Phase I study and characterization of gene-modified autologous gamma delta (γδ) T cells in newly diagnosed glioblastoma multiforme (GBM)
Poster Details: 442 (Abstract 552638)
Presenter: Louis B. Nabors, MD
Date/Time: June 1, 2026, 1:30 PM to 4:30 PM CT (2:30 PM to 5:30 PM EDT)
Following each conference, posters and presentation materials will be available in the Events and Presentations section of the Company’s investor website.

(Press release, In8bio, MAY 6, 2026, View Source [SID1234665189])

Immunocore reports first quarter financial results and provides a business update

On May 6, 2026 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 first quarter ended March 31, 2026, and provided a business update.

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"We are proud to report another quarter of strong commercial performance, with KIMMTRAK generating $107 million in net revenues in Q1 2026," said Bahija Jallal, CEO of Immunocore. "The five-year overall survival (OS) data from our Phase 3 trial presented at AACR (Free AACR Whitepaper) is a landmark moment. It is the longest OS follow-up ever reported in a randomized trial in metastatic uveal melanoma and underscores the long-term benefit KIMMTRAK delivers to patients. In parallel, we are executing with discipline across our pipeline."

First Quarter Highlights (including post-period)

Financial Results

For the first quarter of 2026 (Q1 2026), total net product revenue (or ‘net sales’) arising from the sales of KIMMTRAK was $106.7 million, compared to $93.9 million for the same period in 2025. Q1 2026 sales were $67.4 million in the United States, $34.4 million in Europe, and $4.8 million in 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.

Research & development (R&D) expenses for Q1 2026 were $61.1 million, compared to $56.5 million for Q1 2025. This increase was primarily due to clinical expenses related to the progression of our Phase 3 trials, primarily PRISM-MEL-301.

Selling, general and administrative (SG&A) expenses for Q1 2026 were $37.9 million, compared to $40.2 million for Q1 2025. This decrease was primarily due to increases in forfeitures of share-based compensation.

Net income for Q1 2026 was $13.0 million compared to $5.0 million for Q1 2025.

The Q1 2026 diluted income per share was $0.25 compared to $0.10 for Q1 2025.

Cash, cash equivalents and marketable securities were $844.9 million as of March 31, 2026.

KIMMTRAK
The Company’s lead product, KIMMTRAK (tebentafusp), is approved in 39 countries and has been launched in over 30 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 US community and global market penetration 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 $106.7 million for the first quarter ended March 31, 2026, representing an increase of 13.6%, as compared to the same period in 2025.
19.1% year-over-year sales growth in the United States with mean duration of treatment of 14 months.
4.9% year-over-year sales growth in Europe, driven by increased demand and launches in European markets.
Five-year overall survival (OS) data from the landmark Phase 3 trial of KIMMTRAK in patients with unresectable or mUM were presented in an oral session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2026 meeting, representing the longest follow-up reported for any T cell engager in a solid tumor. In this study of 378 patients, KIMMTRAK doubled the likelihood of being alive at five years with an OS rate of 16% versus 8% in the control arm (HR 0.67), while demonstrating a median OS of 21.6 months compared to 16.9 months for investigator’s choice.
The OS benefit with KIMMTRAK was observed regardless of known poor prognostic factors at baseline (high tumor burden [≥10cm]; elevated lactate dehydrogenase [LDH]) or tumor location (hepatic only; hepatic and extra-hepatic). OS benefit was also observed in patients with a best response of progressive disease, including those with >20% tumor growth as best change on treatment.
The data also confirmed that the OS benefit was primarily driven by KIMMTRAK rather than subsequent therapies. Among patients treated with KIMMTRAK who were alive at five years, nearly half (44%) received only KIMMTRAK, while among patients in the control arm alive at the same time point, 86% subsequently received KIMMTRAK.
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 with topline data expected as early as the second 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 HLA-A*02:01 positive 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 Company is enrolling 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 trials of brenetafusp and IMC-P115C (PRAME-A02 Half-Life Extended) in multiple solid tumors

The Company continues to evaluate brenetafusp in a Phase 1/2 trial in combination in platinum-resistant ovarian cancer (PROC) and in earlier lines of platinum-sensitive ovarian cancer (PSOC). In the same trial, the Company continues signal detection in metastatic NSCLC cohorts, including combination in earlier-line NSCLC.
The Company is enrolling patients in the Phase 1 dose escalation trial evaluating IMC-P115C in patients with multiple solid tumors.
The Company expects to present Phase 1/2 data from both trials in the second half of 2026.

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.
The Company expects to present initial data in 2027.
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’. The Company is studying an investigational candidate for people living with human immunodeficiency virus (HIV).

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 (MAD) part of the Phase 1/2 clinical trial to identify a safe and tolerable dose.
Additional Phase 1 MAD data is expected to be presented in the second half of 2026.
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.

The Company filed a clinical trial application (CTA) for IMC-S118AI (PPI x PD1) in December 2025 and expects to begin the Phase 1 trial in the first half of 2026.
The Company plans to file a CTA or investigational new drug (IND) application for IMC-U120AI (CD1a x PD1) in the second half of 2026.
Corporate update

The Company will present the following two posters at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Meeting:

Title: Phase 1 evaluation of the PRAME-targeted ImmTAC brenetafusp in advanced melanoma (Mel). (Abstract number: 9527)
Session: Melanoma/Skin Cancers (Poster Board: 243)
Date and Time: May 31, 2026, 9:00 AM-12:00 PM CDT

Title: Effect of IL7 on ImmTAC-mediated killing by T cells in vitro and T-cell fitness in patients. (Abstract number: 2662)
Session: Developmental Therapeutics – Immunotherapy (Poster Board: 452)
Date and Time: May 30, 2026, 1:30 PM-4:30 PM CDT

(Press release, Immunocore, MAY 6, 2026, View Source [SID1234665188])

Galapagos Reports First Quarter 2026 Financial Results and Provides Business Update

On May 6, 2026 Galapagos NV (Euronext & NASDAQ: GLPG) reported its financial results for the first quarter of 2026 and provided a business update.

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"Having joined the company just one year ago, I’m thrilled with our progress. I am looking forward to consummating our partnership with Gilead and adding Ouro Medicines’ talented team and its portfolio of programs to our Company, including the potential first and best in class T cell engager in autoimmune diseases, gamgertamig (OM336). We are excited that our Company is rebranding as Lakefront Biotherapeutics as this name reflects our Company’s strategic evolution," said Henry Gosebruch, Chief Executive Officer of Galapagos.

Aaron Cox, Chief Financial Officer of Galapagos, added, "Following the anticipated use of cash to fund our collaboration with Gilead concerning its acquisition of Ouro Medicines, the Company will remain robustly capitalized and will have increased flexibility, including the ability to spend up to $500 million for business development independent of Gilead and not subject to our 2019 Option, License, and Collaboration Agreement with Gilead. This would also include the potential to use up to $150 million of that $500 million for share repurchases to the extent that we have available distributable reserves. In addition to the upfront consideration of $837.5 million, we anticipate additional 2026 Ouro-related cash expenditures to be in the range of €60-75 million, inclusive of R&D costs, one-time transaction costs and assuming a mid-year closing of the transaction."

First Quarter 2026 Business Update

On March 31, 2026, the Company announced that it has entered into a binding agreement (the "Framework Agreement") with Gilead Sciences, Inc. ("Gilead") (the "Transaction") in connection with Gilead’s definitive agreement to acquire all of the outstanding equity interests of US-based Ouro Medicines, LLC ("Ouro"), a privately held biotechnology company focused on developing T cell engager therapies for autoimmune diseases.

Gamgertamig (OM336) is a clinical stage BCMAxCD3 T cell engager designed to enable rapid and deep plasma and B cell depletion following a short duration, subcutaneously administered treatment course. In ongoing Phase 1/2 clinical studies, gamgertamig has demonstrated transformative efficacy and a differentiated safety profile after a single treatment cycle in severe antibody-mediated orphan diseases, including autoimmune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP).

Gamgertamig has been granted both Fast Track and Orphan Drug Designation by the U.S. FDA for the treatment of AIHA and ITP and is expected to enter registrational studies as early as 2027.

BCMA-targeted T cell engagers are being investigated as a precision approach for severe inflammatory and autoimmune diseases by eliminating pathogenic B cells and plasma cells. By redirecting a patient’s own T cells toward BCMA-expressing plasma cells, clinical data suggest these agents can reduce inflammation, improve organ-level disease, and in some cases enable durable, drug-free remission without ongoing immunosuppression.

Update on Binding Agreement with Gilead

The Company expects the Transaction to close in the second quarter of 2026, subject to the fulfillment of the closing conditions.
Galapagos expects to assume substantially all of Ouro’s operating assets and personnel (approximately 20 employees), such that the Company would obtain an operating business.
Galapagos and Gilead will equally split the upfront payment of $1.675 billion (~€1.425 billion1), subject to customary adjustments, and contingent milestone payments of up to $500 million (~€425 million1).
Galapagos and Gilead will collaborate on the development of gamgertamig, with Galapagos responsible for the development costs through initiation of registrational studies, after which the development costs will be shared equally. Galapagos is eligible for up to $100 million in development milestones payments for gamgertamig in certain other indications.
Galapagos will fund its share of payments owed to KeyMed Biosciences Chengdu Co., Ltd. ("KeyMed"), comprising 25% of the milestone payments and 50% of the royalty payments that become due to KeyMed with respect to gamgertamig products. Based on Ouro’s original transaction with Keymed, Keymed is entitled to total development and commercial milestones of up to $610 million and tiered royalties of 7%-14% of net sales for gamgertamig.
Gilead will retain sole worldwide commercialization rights, including all related costs, globally outside of Keymed’s territories, and Galapagos will receive tiered royalties of 20%–23% on net sales of gamgertamig from Gilead.
Galapagos will gain a preclinical portfolio of three additional autoimmune focused programs originally from Ouro, with an opt-in for Gilead for a 50/50 profit split post clinical proof-of-concept for $75 million (~€64 million1) per program.
The proposed arrangements will amend the existing collaboration terms with Gilead to designate $500 million (~€425 million1) of Galapagos’ cash available for R&D or strategic transactions outside of Gilead partnerships, including up to $150 million (~€128 million1) of this $500 million (~€425 million1) for potential return of capital, subject to certain limitations.
In addition to the upfront payment of $837.5 million (~€713 million1), the range of spending expected (including transaction expenses, operating expenses, milestones, and royalties) in 2026 is €60-€75 million.
Following this transaction, including estimated associated R&D spend until first approval, the Company will continue to have a majority of its current cash of approximately €3B remaining for additional strategic transactions and other capital allocation priorities.

CORPORATE

At the Company’s Annual and Extraordinary Shareholders’ Meeting held on April 28, 2026 (the "AGM" and "EGM") all proposed resolutions were approved (see: press release of April 28, 2026), among other items:
the name change to Lakefront Biotherapeutics, with effect as of May 8, 2026. Our ticker on Euronext and NASDAQ (ADRs) will change to LKFT;
Gino Santini’s appointment as a member of our Board of Directors, and pursuant to a vote of our Board of Directors, Gino became the new Chair of our Board of Directors. Gino replaces Jérôme Contamine, whose four-year mandate as a member of the Board of Directors ended upon the conclusions of the AGM;
the authorization to acquire the Company’s own shares.
In April 2026, Coultreon Biopharma BV ("Coultreon"), previously named Onco3R Therapeutics BV, announced the closing of an oversubscribed $125 million Series A financing round. The financing will support the clinical development of Coultreon’s lead immunology program, COL-5671 (formerly O3R-5671), a highly selective SIK3 inhibitor in Phase 1, with potential to demonstrate clinical proof-of-concept in 2027. COL-5671 was initially developed by Galapagos and ownership was fully transferred to Coultreon in April 2025, when Galapagos provided seed financing to the company with a convertible note investment that converted into equity ownership in Coultreon in connection with Series A financing.
IMMUNOLOGY SMALL MOLECULE PIPELINE

As part of our ongoing efforts to maximize the value of the GLPG3667 program for both patients and Galapagos, we are evaluating all strategic options. The GALACELA SLE study with GLPG3667 is currently ongoing, and the final Week 48 data are expected in the second quarter of 2026.
ONCOLOGY CAR-T CELL THERAPY UPDATE

The Company announced in January 2026 the start of the wind-down of its cell therapy activities. The wind-down remains on schedule and is expected to be substantially completed by the end of the third quarter of 2026.
The Company continues to expect 2026 one-time cash costs related to the wind-down to be in the range of €125 million to €175 million.
Financial Guidance
Galapagos currently estimates 2026 cash spend related to Ouro of approximately €775 million to €790 million, inclusive of the upfront payment, transaction costs, and operating costs assuming a mid-year transaction closing. The Company expects its year end 2026 cash and financial investments balance to be in the range of €1.975 billion to €2.050 billion, which reflects a reduction in prior guidance due to expected cash usage related to the Ouro investment and a corresponding reduction in interest income. Galapagos continues to expect one-time cash restructuring costs of €125 million to €175 million related to the ongoing wind-down of the cell therapy activities. All figures assume a EUR/USD exchange rate of 1.175, consistent with year-end 2025. These estimates are subject to change and depend on the timing of closing, final transaction scope, integration activities, exchange rate fluctuations, and remaining cell therapy wind-down costs.

Financial Performance

Key figures for the first quarter of 2026 (consolidated)
(€ millions, except basic & diluted earnings/loss (-) per share)

March 31, 2026 March 31, 2025 % Change
Supply revenues 4.9 13.8 -64%
Collaboration revenues 1.6 61.2 -97%
Total net revenues 6.5 75.0 -91%
Cost of sales (4.8) (13.8) -65%
R&D expenses (31.0) (182.7) -83%

G&A1 and S&M2 expenses (35.5) (43.8) -19%
Other operating income 1.1 6.6 -83%
Operating loss (63.7) (158.7)

Fair value adjustments and net exch­ange differences 64.3 (9.4)
Net other financial result 13.4 11.8
Income taxes (0.1) 1.8
Net profit/loss (-) from continuing operations 13.9 (154.5)
Net profit from discontinued operations, net of tax 0.6 1.1
Net profit/loss (-) of the period 14.5 (153.4)
Basic and diluted earnings/loss (-) per share (€) 0.2 (2.3)
Financial investments, cash & cash equivalents 2,982.2 3,297.3

Details of the financial results for the first quarter of 2026

Total operating loss from continuing operations for the first three months of 2026 amounted to €63.7 million, compared to an operating loss of €158.7 million for the first three months of 2025. The operating loss in 2025 was negatively impacted by the executed strategic reorganization announced in January 2025, for €111.0 million. This was mainly reflected in severance costs of €47.5 million, costs for early termination of collaborations of €42.1 million and impairment on fixed assets related to small molecules activities of €10.2 million, professional services costs of €6.6 million and €4.2 million accelerated non-cash cost recognition for subscription right plans.

Total net revenues amounted to €6.5 million for the first three months of 2026, compared to €75.0 million for the first three months of 2025. The revenue recognition related to the exclusive access rights granted to Gilead for Galapagos’ drug discovery platform amounted to €57.6 million for the first three months of 2025. The deferred income related to the drug discovery platform was fully released in revenue at the end of 2025.
Cost of sales amounted to €4.8 million for the first three months of 2026, compared to €13.8 million for the first three months of 2025, 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 €31.0 million for the first three months of 2026, compared to €182.7 million for the first three months of 2025. In the first three months of 2025, the Company recorded increased personnel expenses (mainly related to severance costs), an impairment on fixed assets (related to small molecules programs) and a provision for early termination of collaboration agreements. On top, due to the wind-down of the cell therapy activities the spending in the CAR-T programs decreased in the first three months of 2026 as compared to the first three months of 2025.
S&M and G&A expenses amounted to €35.5 million for the first three months of 2026, compared to €43.8 million for the first three months of 2025. This decrease was mainly due to lower personnel costs (primarily severance costs).
Other operating income amounted to €1.1 million for the first three months of 2026, compared to €6.6 million for the first three months of 2025, mainly driven by lower grant and R&D incentives income.
Net financial income amounted to €77.7 million for the first three months of 2026, compared to net financial income of €2.4 million for the first three months of 2025.

Fair value adjustments and net currency exchange results amounted to a positive amount of €64.3 million for the first three months of 2026, compared to a negative amount of €9.4 million for the first three months of 2025, and were primarily attributable to €40.0 million of positive changes in fair value of financial investments and €23.8 million of unrealized currency exchange gains on our cash and cash equivalents and financial investments at amortized cost in U.S. dollars.
Net other financial income amounted to €13.4 million for the first three months of 2026, compared to net other financial income of €11.8 million for the first three months of 2025. Net interest income amounted to €12.9 million for the first three months of 2026, compared to €12.0 million of net interest income for the first three months of 2025. Fair value gains and interest income derived from cash, cash equivalents and financial investments excluding any currency exchange results amounted to €24.4 million for the first three months of 2026 (compared to €24.9 million for the same period last year).
The Company reported a net profit from continuing operations of €13.9 million for the first three months of 2026, compared to a net loss from its continuing operations of €154.5 million for the first three months of 2025.

Net profit from discontinued operations related to Jyseleca amounted to €0.6 million for the first three months of 2026, compared to net profit amounting to €1.1 million for the first three months of 2025.

Galapagos reported a net profit of €14.5 million for the first three months of 2026, compared to a net loss of €153.4 million for the first three months of 2025.

Cash position
Financial investments and cash and cash equivalents totaled €2,982.2 million on March 31, 2026, as compared to €2,998.0 million on December 31, 2025. The cash and cash equivalents and financial investments included $2,546.4 million held in U.S. dollars ($2,159.0 million on December 31, 2025) which could generate foreign exchange gains or losses in the financial results in accordance with the fluctuation of the EUR/U.S. dollar exchange rate as the Company’s functional currency is EUR (translated at a rate of 1.1498 €/$ at March 31, 2026).

Total net decrease in cash and cash equivalents and financial investments amounted to €15.8 million during the first three months of 2026, compared to a net decrease of €20.5 million during the first three months of 2025. This net decrease was composed of (i) €77.9 million of operational cash burn3, which includes cash in of €16.1 million related to the return on financial investments, (ii) €60.8 million of positive exchange rate differences, positive changes in fair value of current financial investments, variation in accrued interest income, (iii) €1.0 million acquisition of equity investments, and (iv) €2.3 million of net cash in related to the sale of subsidiaries.

Conference call and webcast presentation

Galapagos will host a conference call on May 7, 2026, at 14:00 CET / 08:00 AM ET. 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 www.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, MAY 6, 2026, View Source [SID1234665187])