On February 5, 2026 Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, reported new clinical data presented at the 2026 Tandem Meetings of ASTCT and CIBMTR from February 4-7 in Salt Lake City.

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Orca-T with Reduced Intensity Conditioning

"Patients undergoing reduced intensity conditioning allogeneic stem cell transplantation often face a tradeoff between tolerability and long-term disease control," said Caspian Oliai, MD, medical director of the UCLA Bone Marrow Transplantation Stem Cell Processing Center, and primary investigator on the SERENE-T Phase 2 study. "The clinical evidence being generated today, which suggests Orca-T may improve key outcomes by reducing GVHD without increasing infection risk or relapse rate, provides a strong foundation for our ongoing evaluation of Orca-T in this setting. The dosing of the first patients in the Phase 2 SERENE‑T study further strengthens this initial momentum, representing a meaningful step forward in expanding the investigation of Orca‑T for patients undergoing reduced intensity conditioning."

SERENE-T (NCT07216443) is a new multicenter, open-label Phase 2 trial evaluating the safety, tolerability and efficacy of Orca-T, Orca Bio’s lead investigational allogeneic T-cell immunotherapy, in patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) undergoing reduced intensity conditioning (RIC) or non-myeloablative conditioning (NMA). The first patients were treated this year at Vanderbilt University, UCLA and Oregon Health & Science University (OHSU) – Knight Cancer Institute. The study continues to enroll patients with plans to open at additional transplant centers across the U.S.

A new analysis compared outcomes from the single-center, open-label Phase 1 investigator-sponsored trial evaluating Orca-T versus a historical cohort of patients from the CIBMTR registry who received a conventional allogeneic hematopoietic stem cell transplant (alloHSCT) with post-transplant cyclophosphamide (PTCy). All patients were aged 60-75 (median 68 years), had a 7/8 or 8/8 human leukocyte antigen (HLA)-matched donor, and were given a RIC for the treatment of AML, acute lymphoblastic leukemia (ALL), MDS or myeloproliferative neoplasm (MPN).

Patients receiving Orca-T (n=53) compared with PTCy (n=587) demonstrated improved:

Overall survival at one year (OS; 88% vs 72%) and two years (84% vs 61%)
Relapse-free survival at one year (RFS; 82% vs 61%) and two years (79% vs 53%)
Graft-versus-host-disease relapse-free survival at one year (GRFS; 72% vs 54%) and two years (72% vs 45%)
Relapse rates at one and two years (9.7% vs 23%, 9.7% vs 30%) and non-relapse mortality at one and two years (NRM; 8% vs 16%, 12% vs 17%).
At one year, rates of Grade 3-4 acute and moderate-to-severe chronic graft versus host disease (aGVHD, cGVHD) were 0% and 10% with Orca-T, respectively, compared to 6% and 10% with PTCy. At two years, rates of cGVHD were 10% with Orca-T and 12% with PTCy.

Orca-T Versus PTCy in Patients with Myelodysplastic Syndromes

A post-hoc analysis of patients aged 18-65 with MDS compared pooled results from the Phase 3 Precision-T study and the Phase 1b study of Orca-T to a historical cohort from the CIBMTR registry of patients who received a conventional alloHSCT and PTCy in the myeloablative conditioning (MAC) HLA-matched setting. Patients with MDS who were treated with Orca-T (n=25) demonstrated higher one-, two- and three-year OS of 100% compared to the PTCy cohort (n=95) with 80%, 70% and 62%, respectively. At one year, the Orca-T arm showed RFS of 95% versus 64% with PTCy and NRM of 0% versus 9.9%, respectively. Notably, these trends were observed across subgroups including age and donor type.

A similar analysis was conducted across multiple hematologic malignancies, including MDS, AML and ALL with consistent results. In this post-hoc analysis, Orca-T (n=164) demonstrated higher OS compared to PTCy (n=380) at one, two and three years (94% vs 82%, 85% vs 73% and 82% vs 65%, respectively). At one year, RFS was 78% with Orca-T compared with 70% with PTCy, while NRM was 2.7% versus 7.7%, respectively. These findings were consistent with the results observed in a subgroup of patients over 50 years of age.

Reliable Manufacturing and Nationwide Distribution of Orca-T

A manufacturing and distribution analysis from the Phase 3 and Phase 1b Orca-T studies conducted between December 2019 and September 2024 reported on the production of 243 clinical cell therapies, including 215 from single-day and 28 from two-day collections. Overall, 100% of products were delivered to transplant centers across the U.S. within 70 hours, with 99% infused within 72 hours. Product quality was consistent across all three Orca-T components: hematopoietic stem cells, regulatory T-cells and conventional T-cells.

These results demonstrate the feasibility of reliably manufacturing and distributing Orca-T at scale while maintaining high product purity within a controlled logistics framework, supporting multicenter clinical studies and potential future commercial application.

"These data continue to reinforce the strength of Orca-T across both clinical outcomes and operational execution," said Nate Fernhoff, Ph.D., co-founder and chief executive officer at Orca Bio. "The consistency of these results, along with our ability to reliably manufacture and deliver Orca-T across the U.S., highlights the potential of this therapy to make a meaningful difference for patients with hematologic malignancies. As we move toward a potential launch later this year, we remain focused on executing with the same level of commitment and rigor to support patients, clinicians and transplant centers."

Orca-Q for Patients with Haploidentical Donors

New findings from the ongoing Phase 1 study of Orca-Q, Orca Bio’s second-generation investigational allogeneic T-cell immunotherapy, evaluated 39 patients with AML, ALL or MDS and a haploidentical donor who received MAC with Bu/Flu/Thiotepa (BFT), TBI/Flu/Thio (TFT) or TBI/Flu. All patients engrafted by Day +19 (median 11 days) and demonstrated encouraging rates of OS at one, two and three years (80%, 77% and 77%, respectively). Patients demonstrated RFS of 77% and GRFS of 72%, with low incidences of Grade 3-4 aGVHD at Day +180 and moderate-to-severe cGVHD at one year (8.1% and 0%, respectively). Outcomes were further improved in the TFT subgroup (n=14) across OS (85%), RFS (85%), GRFS (85%), aGVHD (0%) and cGVHD (0%).

About Orca-T
Orca-T is an investigational allogeneic T-cell immunotherapy under evaluation for the treatment of multiple hematologic malignancies including acute leukemias and myelodysplastic syndromes. Orca-T is composed of highly purified regulatory T-cells, hematopoietic stem cells and conventional T-cells derived from either related or unrelated matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation for the prevention of graft versus host disease or death in patients eligible for hematopoietic stem cell transplant from the U.S. Food and Drug Administration (FDA). The Biologics License Application (BLA) for Orca-T is currently under Priority Review with the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of April 6, 2026.

About Orca-Q
Orca-Q is Orca Bio’s second-generation investigational allogeneic T-cell immunotherapy being evaluated in clinical trials for the treatment of multiple hematologic malignancies, including in patients with haploidentical and mismatched donors. Orca-Q is a proprietary composition of stem cells combined with specific T-cell subsets derived from healthy donors and engineered by Orca Bio’s high-precision platform.

(Press release, Orca Bio, FEB 5, 2026, View Source;utm_medium=rss&utm_campaign=orca-bio-presents-new-data-at-the-2026-tandem-meetings-of-astct-and-cibmtr-reinforcing-orca-t-as-a-durable-high-precision-cell-therapy-for-hematological-malignancies [SID1234662509])

On February 5, 2026 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported data demonstrating a best-in-class profile for commercial Amtagvi (lifileucel) with unprecedented response rates in a real-world clinical, retrospective study in patients with advanced (unresectable or metastatic) melanoma. Amtagvi is the first one-time T cell therapy for a solid tumor cancer as well as the only FDA-approved treatment for advanced melanoma patients previously treated with anti-PD-1 and targeted therapy, where applicable.

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The real-world results were highlighted in an oral presentation at the 2026 Tandem Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood and Marrow Transplant Research (CIBMTR) in Salt Lake City, UT.

Forty-one evaluable patients with previously treated advanced melanoma received commercial Amtagvi according to the U.S. prescribing information at four authorized treatment centers. The physician-assessed confirmed objective response rate (ORR) was 44% (18/41) and the disease control rate was 73% (30/41). Response rates were higher with earlier Amtagvi treatment. The ORR was 52% (12/23) following two or fewer lines of therapy compared to an ORR of 33% (6/18) after three or more lines of therapy. The unprecedented real-world response rates also improved upon the 31% ORR in the C-144-01 clinical trial that supported the U.S. FDA accelerated approval of Amtagvi.

Lilit Karapetyan, MD, MS of H. Lee Moffitt Cancer Center & Research Institute stated, "The real-world response rate builds on existing clinical data and supports consideration of lifileucel as soon as possible after immune checkpoint inhibitor treatment. An overall response rate of 44% was observed in the full cohort, with a 52% response rate among patients treated in earlier lines of therapy. I am encouraged by the potential for an increasing number of patients to benefit as adoption of TIL therapy continues."

Daniel Kirby, Chief Commercial Officer of Iovance, stated, "The real world Amtagvi data with impressive response rates, paired with unprecedented five-year durability and survival data, demonstrate a best-in-class profile and better outcomes in patients treated earlier."

Previously treated advanced melanoma represents an unmet medical need with more than 8,000 annual U.S. deaths.1 More than half of patients treated with first line standard of care will progress within 12 months.2 The U.S. FDA granted accelerated approval for Amtagvi in February 2024 based on ORR and duration of response (DOR) from the C-144-01 clinical trial. The published final five-year analysis demonstrated unprecedented durability and follow-up in previously treated advanced melanoma patients, with ~31% ORR, median DOR of 36+ months, and a 20% five-year overall survival.3 Iovance is conducting TILVANCE-301, a Phase 3 clinical trial in frontline advanced melanoma, to confirm clinical benefit.

1. National Cancer Institute Surveillance, Epidemiology and End Results (SEER) Program. 2025 Estimates. View Source (accessed February 2026)
2. Larkin J, et al. NEJM; Robert C, et al. Lancet; Tawbi HA, et al. NEJM
3. Medina T, et al. JCO

About Amtagvi

Amtagvi is a prescription medicine used to treat adults with a type of skin cancer that cannot be removed surgically or has spread to other parts of the body called unresectable or metastatic melanoma.

Amtagvi is used when your melanoma has not responded or stopped responding to a PD-1 blocking drug either by itself or in a combination, and if your cancer is BRAF mutation positive, a BRAF inhibitor drug with or without a MEK inhibitor drug that has also stopped working.

The approval of Amtagvi is based on a study that measured response rate. Continued approval for this use may depend on the results of an ongoing study to confirm benefit.

Important Safety Information

What is the most important information that I should know about Amtagvi?

You will likely be in a hospital prior to and after receiving Amtagvi.

Before taking Amtagvi, tell your healthcare provider about all of your medical conditions, including if you:

Have any lung, heart, liver or kidney problems
Have low blood pressure
Have a recent or active infection or other inflammatory conditions including cytomegalovirus (CMV) infection, hepatitis B or C or human immunodeficiency virus (HIV) infection
Are pregnant, think you may be pregnant, or plan to become pregnant
Are breastfeeding
Notice the symptoms of your cancer are getting worse
Have had a vaccination in the past 28 days or plan to have one in the next few months
Have been taking a blood thinner
Tell your doctor about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive Amtagvi?

Amtagvi is made from your surgically removed tumor. Tumor derived T cells are grown in a manufacturing center at the end of which they number in the billions of cells.
Your tumor tissue is sent to a manufacturing center to make Amtagvi. It takes about 34 days from the time your tumor tissue is received at the manufacturing center until Amtagvi is available to be shipped back to your healthcare provider, but the time may vary. Your Amtagvi will be provided in 1-4 patient-specific infusion bag(s) containing 100 mL to 125 mL of viable (alive) cells per bag.
After your Amtagvi arrives at your treating institution, your healthcare provider will give you lymphodepleting chemotherapy to prepare your body.
Approximately 30 to 60 minutes before you are given Amtagvi, you may be given other medicines including:
Medicines for an allergic reaction (anti-histamines)
Medicines for fever (such as acetaminophen)
Your Amtagvi will be provided in 1 to 4 infusion bag(s) containing 100 mL to 125 mL of viable cells per bag. When your body is ready for Amtagvi infusion, your healthcare provider will give Amtagvi to you by intravenous infusion. This usually takes less than 90 minutes.
After getting Amtagvi

Beginning 3 to 24 hours after Amtagvi is given, you may be given up to 6 doses of IL-2 (aldesleukin) every 8 to 12 hours via intravenous infusion. Your doctor may discontinue IL-2 (aldesleukin) infusion any time if you have severe side effects.

You will have to stay in the hospital until you have completed the IL-2 (aldesleukin) treatment and you have recovered from any serious side effects associated with the Amtagvi treatment.

You should plan to stay within 2 hours of the location where you received your treatment for several weeks after getting Amtagvi. Your healthcare provider will check to see if your treatment is working and help you with any side effects that occur.

What are the possible side effects of Amtagvi?

The most common side effects of the Amtagvi treatment include chills, fever, low white blood cell count (may increase risk of infections), fatigue, low red blood cell count (may cause you to feel tired or weak), fast or irregular heartbeat, rash, low blood pressure, and diarrhea.

These are not all the possible side effects of the Amtagvi treatment. Talk with your healthcare provider for more information about Amtagvi. You can ask your healthcare provider for information about Amtagvi that is written for healthcare professionals.

You may report side effects to Iovance at 1-833-400-4682, or to the FDA, at 1-800-FDA-1088 or at View Source

Please see Full Prescribing Information and Patient Information, including Boxed Warning, for additional Important Safety Information.

(Press release, Iovance Biotherapeutics, FEB 5, 2026, View Source [SID1234662508])

On February 5, 2026 IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, reported a strategic reorganization that will eliminate headcount not essential to the Phase 3 trial and redefine the job descriptions for additional employees to reduce operating expenses while supporting the company’s focused strategy to rapidly advance the pivotal OVATION 3 Phase 3 clinical trial in women with newly diagnosed advanced ovarian cancer. The company also announced that Khursheed Anwer, Ph.D., MBA, Executive Vice President and Chief Scientific Officer, who has been at IMUNON for nearly 12 years and who led the initial development of the company’s proprietary TheraPlas platform technology, will retire effective February 20, 2026.

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"We have made significant progress and built strong momentum in 2025 with our lead IMNN-001 program, including reporting unprecedented Phase 2 clinical data at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting and in the peer-reviewed journal Gynecologic Oncology that showed a median 13-month increase in overall survival in combination with standard of care chemotherapy," said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. "Our highest priority now is to continue enrollment ahead of projections and to activate a full complement of clinical sites to complete this landmark research as quickly as possible. To support this, as we have always done, we have taken steps to improve our efficient use of resources. The flexibility of our workforce, a hallmark of Imunon’s ability to achieve its objectives, will ensure that we have the resources in place to build new levels of momentum in our Phase 3 trial in the months ahead."

"Dr. Khursheed Anwer’s decision to retire comes at a time of transition for the Company as we move to focus on the commercial potential of his career research, DNA-mediated immunotherapy. His scientific leadership, many contributions to advancing our business strategy, and lifelong commitment to patients have played a central role in our success and our goal to transform the broader cancer treatment landscape. On behalf of IMUNON and our Board of Directors, I would like to express our deep gratitude to Khursheed for his extraordinary contributions to cancer research, the medical community, and IMUNON over the last decade," added Dr. Lindborg.

"It has been a privilege for us to use the scientific knowledge to develop the TheraPlas platform and I am very proud of the achievements and groundbreaking innovations we have advanced since joining IMUNON in 2014," said Dr. Anwer. "Building on this work, the IMUNON team has the clear potential to deliver a novel and highly effective IL-12 immunotherapy to the thousands of women with advanced ovarian cancer who desperately need new treatment options."

About the OVATION 3 Study

OVATION 3 is IMUNON’s pivotal Phase 3 study of IMMN-001, an IL-12 gene-mediated immunotherapy, in women with advanced stage epithelial ovarian cancer. The study is supported with unprecedented overall survival (OS) data from a large, 112-patient, randomized Phase 2 study (OVATION 2) showing the following:

Median 13-month increase in OS (HR 0.70) and median 3-month increase in PFS (HR 0.79) in IMNN-001 treatment arm compared to standard of care alone.
Better therapeutic effect observed with IMNN-001 treatment compared to the control arm (p=0.0375), as shown by mean 6.5-month extension of time free of progression or death (PFS + OS) captured in totality of treatment effect.
Use of poly ADP-ribose polymerase (PARP) inhibitors as part of maintenance therapy, which further enhanced outcomes, with median OS not yet reached in the IMNN-001 treatment arm as patients surpass 5 years since randomization in the trial compared to median OS of 37 months on standard of care (HR 0.42).

The results from the OVATION 2 Study have led to invitations to present data from the Phase 2 Study at both the ASCO (Free ASCO Whitepaper) and ESMO (Free ESMO Whitepaper) annual meetings and in the peer-reviewed journal Gynecologic Oncology.

The OVATION 3 trial is a robustly designed clinical study with at least 95% statistical power on the primary endpoint of overall survival. The trial design includes two planned interim analyses of the primary endpoint, designed to allow for an accelerated timeline for FDA submission of an IMNN-001 BLA if the primary endpoint reaches statistical significance. OVATION 3 is currently enrolling patients at five clinical sites with up to 46 additional sites being considered for activation.

About IMNN-001 Immunotherapy

Designed using IMUNON’s proprietary TheraPlas platform technology, IMNN-001 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. IMUNON previously reported positive safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel neoadjuvantly in patients with newly diagnosed ovarian cancer. IMUNON previously reported positive results from the recently completed Phase 2 OVATION 2 Study, which assessed IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin compared to standard-of-care N/ACT alone in 112 patients with newly diagnosed advanced ovarian cancer.

About Epithelial Ovarian Cancer

Epithelial ovarian cancer is the sixth deadliest malignancy among women in the U.S. There are approximately 20,000 new cases of ovarian cancer every year and approximately 70% are diagnosed in advanced stage III/IV. Epithelial ovarian cancer is characterized by dissemination of tumors in the peritoneal cavity with a high risk of recurrence (75%, stage III/IV) after surgery and chemotherapy. Since the five-year survival rates of patients with stage III/IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for a regional approach to immune modulation.

(Press release, IMUNON, FEB 5, 2026, View Source [SID1234662507])

On February 5, 2026 Illumina, Inc. (Nasdaq: ILMN) ("Illumina" or the "company") reported its financial results for the fourth quarter and fiscal year 2025.

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"The Illumina team delivered a strong finish to 2025, marking a return to growth through disciplined execution against our strategy," said Jacob Thaysen, Chief Executive Officer of Illumina. "Momentum built in the second half of the year – especially in clinical markets, where adoption of NGS-based testing is expanding – reinforces our confidence as we enter 2026."

Fourth quarter results

GAAP Non-GAAP (a)
Dollars in millions, except per share amounts
Q4 2025
Q4 2024
Q4 2025
Q4 2024
Revenue
$ 1,159 $ 1,104 $ 1,159 $ 1,104
Gross margin
65.5 % 65.9 % 67.0 % 67.4 %
Research and development (R&D) expense $ 239 $ 256 $ 238 $ 255
Selling, general and administrative (SG&A) expense $ 310 $ 279 $ 264 $ 271
Legal contingency and settlement $ 8 $ 18 $ — $ —
Operating profit
$ 202 $ 175 $ 275 $ 218
Operating margin 17.4 % 15.8 % 23.7 % 19.7 %
Tax provision $ 44 $ 70 $ 50 $ 47
Tax rate 11.6 % 37.9 % 19.5 % 23.7 %
Net income $ 334 $ 117 $ 208 $ 152
Diluted EPS $ 2.16 $ 0.73 $ 1.35 $ 0.95

(a)See tables in "Results of Operations – Non-GAAP" section below for GAAP and non-GAAP reconciliations.

Capital expenditures for free cash flow purposes were $54 million for Q4 2025. Cash flow provided by operations was $321 million, compared to $364 million in the prior year period. Free cash flow (cash flow provided by operations less capital expenditures) was $267 million for the quarter, compared to $322 million in the prior year period. Depreciation and amortization expense was $67 million for Q4 2025. At the close of the quarter, the company held $1.63 billion in cash, cash equivalents and short-term investments.
Fiscal year results
GAAP Non-GAAP (a)
Dollars in millions, except per share amounts
2025 2024 2025 2024
Revenue (b) $ 4,343 $ 4,332 $ 4,343 $ 4,332
Gross margin
66.1 % 67.1 % 68.2 % 68.6 %
R&D expense
$ 967 $ 988 $ 950 $ 982
SG&A expense
$ 1,086 $ 900 $ 1,009 $ 1,069
Goodwill and intangible impairment $ — $ 3 $ — $ —
Legal contingency and settlement $ 10 $ (456) $ — $ —
Operating profit
$ 807 $ 1,473 $ 1,004 $ 922
Operating margin 18.6 % 34.0 % 23.1 % 21.3 %
Tax provision $ 236 $ 229 $ 194 $ 204
Tax rate 21.7 % 20.4 % 20.5 % 23.6 %
Net income $ 850 $ 894 $ 756 $ 663
Diluted EPS $ 5.45 $ 5.61 $ 4.84 $ 4.16

(a)See tables in "Results of Operations – Non-GAAP" section below for GAAP and non-GAAP reconciliations.
(b)Core Illumina revenue for 2024 included intercompany revenue of $15 million, which, prior to the spin-off of GRAIL in Q2 2024, was eliminated in consolidation.

Capital expenditures for free cash flow purposes were $148 million for fiscal year 2025. Cash flow provided by operations was $1.1 billion and free cash flow was $931 million. Depreciation and amortization was $270 million.

Key announcements since our last earnings release
•Completed the acquisition of SomaLogic, expanding Illumina’s multiomics portfolio and strengthening its position in scalable, NGS-enabled proteomics
•Introduced the Billion Cell Atlas, the first data product of the BioInsight business, to support AI-enabled drug discovery; AstraZeneca, Merck, and Eli Lilly are the first pharmaceutical partners
•Announced appointment of veteran genomics leader Eric Green, MD, PhD, as Chief Medical Officer to advance clinical genomics and expand access to precision medicine
•Achieved progress in China, where the Chinese Ministry of Commerce (MOFCOM) lifted the export ban on Illumina sequencers; the company remains on the Unreliable Entities List (UEL) in China, requiring approvals for instrument purchases

A full list of recent announcements can be found in the company’s News Center.

Financial outlook and guidance
The company provides forward-looking guidance on a non-GAAP basis, including on a constant currency basis for revenue and revenue growth rates. The company is unable to provide a reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP reported financial measures because it is unable to predict with reasonable certainty the impact of items such as acquisition-related expenses, fair value adjustments to contingent consideration, gains and losses from strategic investments, potential future asset impairments, restructuring activities, the ultimate outcome of pending litigation, and currency exchange rate fluctuations without unreasonable effort. These items are uncertain, inherently difficult to predict, depend on various factors, and could have a material impact on GAAP reported results for the guidance period. For the same reasons, the company is unable to address the significance of the unavailable information, which could be material to future results.

Conference call information
The conference call will begin at 1:30 pm Pacific Time (4:30 pm Eastern Time) on Thursday, February 5, 2026. Interested parties may access the live webcast via the Investor Info section of Illumina’s website or directly through the following link – View Source To ensure timely connection, please join at least ten minutes before the scheduled start of the call. A replay of the conference call will be posted on Illumina’s website after the event and will be available for at least 30 days following.

(Press release, Illumina, FEB 5, 2026, View Source [SID1234662506])

On February 5, 2026 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Shanghai Henlius Biotech, Inc. (Headquarters: Shanghai, China, CEO: Jason Zhu, "Henlius") reported the conclusion of an exclusive commercialization and co-exclusive development and manufacturing license agreement for the anti-PD-1 antibody serplulimab (generic name, marketed as HANSIZHUANG in China and Hetronifly in the EU) in Japan.

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Serplulimab, a novel anti-PD-1 monoclonal antibody developed by Henlius, is reported to possess a unique binding mode that differs from existing anti-PD-1 antibodies.[1] In China, it has been approved for indications such as squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), non-squamous non-small cell lung cancer (nsNSCLC), and esophageal squamous cell carcinoma (ESCC). In the EU, it has been approved for ES-SCLC. It is the world’s first anti-PD-1 antibody to be used as a first-line treatment for ES-SCLC.

In Japan, Henlius is currently conducting a Phase II bridging clinical trial for ES-SCLC, and plans to submit an application for fiscal year 2026 based on the results of this trial as well as the Phase III clinical trial data that supported approvals for this indication in China and Europe. Furthermore, a Phase III multi-national clinical trial for non-high-frequency microsatellite instability (non-MSI-High) metastatic colorectal cancer is underway, with development for new indications also planned.

In Japan, it is estimated that there are approximately 13,000 patients diagnosed with ES-SCLC and about 28,000 patients diagnosed with non-MSI-High metastatic colorectal cancer, both of which are considered to have high unmet medical needs.[2],[3],[4],[5]

Under the terms of this agreement, Eisai will obtain exclusive rights to commercialize serplulimab in Japan. In addition to ES-SCLC and non-MSI-High metastatic colorectal cancer, Henlius plans to also conduct a clinical trial for perioperative gastric cancer in Japan, and will assume the responsibilities of the Marketing Authorization Holder.

Eisai will pay Henlius a contractual upfront payment of USD 75 million (approximately JPY 11.6 billion*), in addition to regulatory milestone payments of up to USD 80.01 million (approximately JPY 12.4 billion), and sales milestone payments of up to USD 233.3 million (approximately JPY 36.2 billion). Furthermore, Eisai will pay double-digit royalties based on sales of the product. Eisai anticipates no changes to its consolidated financial forecast for the period ending March 31, 2026.

"We are pleased to collaborate with Eisai in Japan to advance the development of serplulimab in this important market," said Dr. Jason Zhu, CEO of Henlius. "Serplulimab has demonstrated its potential across multiple tumor types through global clinical development and regulatory approvals, and Japan represents a critical step in its international journey. By combining Henlius’ innovation capabilities with Eisai’s deep local expertise, we aim to support the efficient development of serplulimab and address unmet medical needs for patients in Japan."

"Serplulimab is an anti-PD-1 monoclonal antibody that has been developed with high priority for indications with significant unmet medical needs, including ES-SCLC, and has already obtained approval for multiple indications in China and the EU. We anticipate that it will also become a promising treatment option in Japan for ES-SCLC and non-MSI-high metastatic colorectal cancer, for which development is underway, as well as for other intractable cancers," said Toshihiko Yusa, Executive Officer and Head of Japan Business at Eisai. "Eisai will make every effort, in cooperation with Henlius, to deliver serplulimab to patients as soon as possible."

* Converted at an exchange rate of USD 1 = JPY 155

About Serplulimab
Serplulimab (generic name, marketed as HANSIZHUANG in China and Hetronifly in the EU) is an anti-PD-1 monoclonal antibody first developed by Shanghai Henlius Biotech, Inc. ("Henlius"), and launched in China in 2022. It has been approved by the National Medical Products Administration of China for indications including squamous non-small cell lung cancer, extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma, and non-squamous non-small cell lung cancer, and is the world’s first anti-PD-1 antibody to be used as a first-line treatment for ES-SCLC. It has been approved for the treatment of ES-SCLC in over 40 markets, including the EU, Southeast Asia (Indonesia, Cambodia, Thailand, Singapore, Malaysia), and South America (Peru).

Henlius is actively promoting the broader use of serplulimab both as a standalone product and in combination with other innovative therapies, including those developed in-house and externally. Furthermore, the company is conducting numerous clinical trials worldwide on therapies for conditions where existing anti-PD-1 antibodies have not yet been used, focusing on indications such as lung cancer and gastrointestinal tumors.

(Press release, Eisai, FEB 5, 2026, View Source [SID1234662505])