Illumina Announces Preliminary Unaudited Financial Results for Fourth Quarter and Fiscal Year 2025

On January 13, 2026 Illumina, Inc. (Nasdaq: ILMN) ("Illumina" or the "company") reported unaudited preliminary financial results for the fourth quarter and fiscal year 2025 ahead of its presentation at the 44th Annual J.P. Morgan Healthcare Conference on January 13, 2026 at 7:30 a.m. Pacific Time (10:30 a.m. Eastern Time). The webcast can be accessed through Illumina’s website at investor.illumina.com.

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Preliminary fourth quarter 2025 results:
•Revenue of approximately $1.155 billion, up 5% from Q4 2024 (up 4% on a constant currency basis)
•Ex-China revenue of approximately $1.100 billion, up 7% from Q4 2024 (and on a constant currency basis)
•GAAP diluted EPS of $2.14 to $2.17 and non-GAAP diluted EPS of $1.27 to $1.30

Preliminary fiscal year 2025 results:
•Revenue of approximately $4.34 billion, flat compared to 2024 (and on a constant currency basis)
•Ex-China revenue of approximately $4.10 billion, up 2% from 2024 (and on a constant currency basis)
•GAAP diluted EPS of $5.42 to $5.45 and non-GAAP diluted EPS of $4.76 to $4.79

As previously announced, the company expects to report its full fourth quarter and fiscal year 2025 results following the close of market on Thursday, February 5, 2026. The unaudited results in this press release are preliminary and subject to the completion of accounting and annual audit procedures and are therefore subject to adjustment.

Statement regarding use of non-GAAP financial measures
The company reports non-GAAP results for diluted earnings per share, net income, gross margin, operating expenses, including research and development expense, selling general and administrative expense, legal contingency and settlement, and goodwill and intangible impairment, operating income, operating margin, gross profit, other income (expense), tax provision, constant currency revenue and growth, and free cash flow (on a consolidated and, as applicable, segment basis) in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The company’s financial measures under GAAP include substantial charges such as amortization of acquired intangible assets among others that are listed in the reconciliations of GAAP and non-GAAP financial measures included in this press release, as well as the effects of currency translation. Management has excluded the effects of these items in non-GAAP measures to assist investors in analyzing and assessing past and future operating performance. Non-GAAP net income, diluted earnings per share and operating margin are key components of the financial metrics utilized by the company’s board of directors to measure, in part, management’s performance and determine significant elements of management’s compensation.

The company encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP information and the reconciliation between these presentations, to more fully understand its business. Reconciliations between GAAP and non-GAAP results are presented in the tables of this release.

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.

(Press release, Illumina, JAN 13, 2026, View Source [SID1234662012])

Evaxion expands AI-Immunology™ platform into autoimmune diseases

On January 13, 2026 Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported it will expand the use of its proprietary AI-Immunology platform to also discover and develop new treatments for autoimmune diseases. Thus, Evaxion will in the future work within cancers, infectious and autoimmune diseases as its core disease areas.

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The expansion leverages the unique scalability of AI-Immunology and will increase the pool of diseases for which we can decode the immune system and potentially discover and develop new treatments. In turn, this will improve the quantity and quality of new programs within our pipeline, potentially available for partnership. Autoimmune diseases are characterized by high unmet medical need and offer significant partnership potential across all stages of drug development.

"Autoimmune diseases can be severely debilitating and even lethal, placing a substantial burden on patients, their families and on society across all stages of life. With AI-Immunology we have a unique technology and a platform that we know can deliver new treatment opportunities. By expanding the platform into autoimmune diseases, we have the potential to meaningfully improve the outcome for patients and unlock significant partnership value from the platform," says Helen Tayton-Martin, CEO at Evaxion.

We plan to expand and train AI-Immunology to be applicable to autoimmune diseases during the second half of 2026. Specifically, the AI-Immunology platform potentially allows for development of precision treatments targeting underlying disease mechanisms, in contrast to current treatment approaches that primarily address symptoms. The related work on the autoimmune disease application development is already included in Evaxion’s cashflow outlook and does not impact our cash runway, which still extends to the second half of 2027.

2026 company milestones
The expansion to autoimmune diseases represents a new strategic milestone for Evaxion in addition to other milestones for 2026 as outlined below. These reflect continued execution of our strategy of creating value from both our platform and pipeline assets through partnerships.

Milestone Target
EVX-01 Additional biomarker and immunogenicity data H1
AI-Immunology New application for autoimmune diseases H2
EVX-01 Three-year phase 2 clinical efficacy data H2
EVX-04 Regulatory filing for phase 1 trial H2
EVX-B4 Design and preclinical validation of antigens H2

(Press release, Evaxion, JAN 13, 2026, View Source [SID1234662011])

Coherus Oncology value proposition

On January 13, 2026 Coherus oncology presented its corporate presentation.

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(Presentation, Coherus Oncology, JAN 13, 2026, View Source [SID1234662010])

Applied Cells and Immuneel Therapeutics announce strategic collaboration to advance affordable CAR-T therapies

On January 13, 2026 Applied Cells Inc. reported a strategic collaboration framework with Immuneel Therapeutics Private Limited to jointly evaluate the application of Applied Cells’ MARS Atlas platform and GoFast CAR-T workflow for future CAR-T therapy development and manufacturing.

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Under this collaboration, the two companies will work together to integrate the MARS Atlas platform and GoFast workflow into selected Immuneel CAR-T programs. The shared objective is to significantly improve the affordability and accessibility of CAR-T therapies, beginning in India, with the potential for broader global adoption.

A key focus of the collaboration is achieving manufacturing costs that enable truly affordable CAR-T therapy for the majority of eligible patients in India, while maintaining therapeutic efficacy comparable to currently approved CAR-T treatments. ‘We are thrilled to partner with Immuneel, a pioneer in bringing cutting‑edge cell therapies to India,’ said Yuchen Zhou, CEO of Applied Cells. ‘The combination of MARS Atlas and the GoFast workflow with Immuneel’s clinical and regulatory capabilities has the potential to transform the CAR‑T landscape by making these life‑saving treatments accessible to millions who currently cannot afford them.’

‘At Immuneel, our mission is to make advanced cell therapies accessible and affordable for patients who need them the most,’ said Amit Mookim, CEO of Immuneel Therapeutics. ‘This collaboration represents an important step in evaluating innovative technologies that could strengthen our manufacturing capabilities and support development of scalable, cost‑effective CAR‑T solutions. We look forward to jointly exploring how platforms like MARS Atlas and the GoFast workflow could contribute to expanding access to high‑quality cell therapies in India and beyond.’

Both companies have commenced collaborative activities and will share updates as the programs progress.

(Press release, Applied Cells, JAN 13, 2026, https://appliedcells.com/immuneel-cart-collaboration/ [SID1234662008])

Immunofoco Presents Phase I/IIa Data of IMC002 at ASCO GI 2026, Highlighting a Durable Complete Response Beyond One Year and a 66.7% ORR in Advanced GC/GEJ

On January 13, 2026 Immunofoco, a clinical-stage biotechnology company advancing innovative CAR-T cell therapies for solid tumors, reported clinical data from its Phase I/IIa study of IMC002, a VHH-based anti-CLDN18.2 CAR-T therapy, in patients with advanced gastric cancer and gastroesophageal junction cancer (GC/GEJ). The data were presented as a poster (Abstract No. 398) at the 2026 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI 2026).

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The study is a multicenter, open-label, dose-escalation Phase I/IIa trial designed to evaluate the safety, tolerability, and preliminary efficacy of IMC002 in patients with CLDN18.2-positive, locally advanced or metastatic GC/GEJ who had failed at least two prior lines of systemic therapy. The results presented at ASCO (Free ASCO Whitepaper) GI 2026 focus on the GC/GEJ cohort.

As of the data cutoff on August 8, 2025, 16 patients had received a single infusion of IMC002 and were included in the safety analysis, with 15 patients evaluable for efficacy. IMC002 demonstrated a favorable and manageable safety profile, with no dose-limiting toxicities observed during the dose-escalation phase. Cytokine release syndrome (CRS) occurred in all patients but was limited to Grade 1 or 2, and no Grade ≥3 CRS, ICANS, or treatment-related deaths were reported.

In evaluable patients, IMC002 achieved an objective response rate (ORR) of 66.7% (10/15). Survival data were immature at the time of analysis, with a median progression-free survival (mPFS) of 7.0 months (95% CI: 3.9, NA) and a median overall survival (OS) of 10.3 months (95% CI: 6.1, NA).

Notably, one patient in the 2.5×10⁸ CAR-T cell dose cohort achieved a complete response (CR) and has remained tumor-free for 60 weeks, demonstrating antitumor activity following IMC002 treatment in a heavily pretreated setting.

Further analyses indicated that IMC002 provided clinically meaningful PFS benefits in third-line and later-line GC/GEJ patients, comparing favorably with historical outcomes reported for this population. Together with its well-tolerated safety profile, these findings support the continued clinical development of IMC002 and its potential evaluation in earlier-line treatment settings.

"IMC002 demonstrated a controllable safety profile and encouraging antitumor activity in patients with advanced gastric and gastroesophageal junction cancers, including those who had failed multiple prior lines of therapy," said Professor Jianming Xu, corresponding author of the study and Professor at the First Medical Center of the Chinese PLA General Hospital. "Of particular clinical significance, one patient achieved a complete response lasting for more than one year. These findings provide important clinical evidence supporting the application of CLDN18.2-targeted CAR-T therapy in solid tumors, and the favorable safety profile also opens the possibility for future exploration in earlier-line settings and strategies aimed at long-term clinical benefit."

IMC002 is a novel CLDN18.2-targeted CAR-T cell therapy incorporating a highly specific VHH domain, designed to enhance tumor targeting while maintaining a favorable safety profile in solid tumors. Based on the encouraging results from this Phase I/IIa study, a Phase III randomized controlled trial of IMC002 in late-line GC/GEJ patients has been initiated.

The presentation at ASCO (Free ASCO Whitepaper) GI 2026 highlights Immunofoco’s continued progress in advancing CAR-T cell therapies for solid tumors and underscores the therapeutic potential of CLDN18.2-targeted approaches in addressing significant unmet medical needs in advanced gastrointestinal cancers.

(Press release, Immunofoco, JAN 13, 2026, View Source;highlighting-a-durable-complete-response-beyond-one-year-and-a-66-7-orr-in-advanced-gcgej-302659498.html [SID1234661990])