On March 2, 2026 Egle Therapeutics SAS (Egle), a clinical-stage biotechnology company pioneering precision medicines that modulate regulatory T cells (Tregs) to rebalance immune function in patients with autoimmune diseases and cancer, reported it was awarded approximately €8 million in grant funding by Horizon Europe, the European Commission’s key funding program for research and innovation. This funding from the European Union will support an Egle-led initiative in partnership with a consortium of four leading European scientific institutions to advance the clinical development of EGL-001, a novel anti-CTLA-4 x IL-2m fusion protein, and to facilitate a comprehensive translational research program to de-risk later-stage clinical development.

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"This Horizon Europe funding strengthens our ability to advance EGL-001’s clinical development and significantly expand the translational research needed to guide patient selection alongside several leading European partners. The grant enables the evaluation of EGL-001 by studying therapy-naïve patients in the neoadjuvant setting and focusing on head and neck squamous cell carcinoma as a single, well-defined indication," said John Celebi, CEO of Egle Therapeutics. "In parallel, we are advancing our ongoing Phase 1/2 study of EGL-001, where it has been well tolerated with early signs of single-agent activity in PD-(L)1-resistant disease. We remain on track to report top-line data from this study in the second half of this year and look forward to bringing our Treg-focused product candidates closer to patients in need."

As part of this initiative, Egle will collaborate with University College London (United Kingdom), Vall d’Hebron Institute of Oncology (VHIO) (Spain), Gustave Roussy (France), and Technical University of Dresden (Germany) to conduct a multicenter, randomized, open-label Phase 1/2 neoadjuvant clinical trial in patients with head and neck squamous cell carcinoma (HNSCC), a high-incidence, high-mortality cancer with limited benefit from current immunotherapies. This trial will evaluate the safety, tolerability, and early efficacy of EGL-001 in combination with pembrolizumab in these patients.

This initiative also integrates a comprehensive translational research program, including multi-omics profiling, immune monitoring, and AI-driven pathomics modeling, to deliver predictive biomarkers for patient stratification, ultimately supporting regulatory alignment and de-risking later-stage development. The consortium also provides cutting-edge expertise in immunology, genomics, pathology, and computational biology, alongside established clinical trial capacity across EU member states.

"EGL-001 represents a highly differentiated, Treg-based approach to cancer treatment that is designed to selectively disarm and remove regulatory T cells inside tumors, making tumor types with prominent Treg-driven immune suppression, including HNSCC, compelling settings for clinical evaluation," said Prof. Aurélien Marabelle, M.D., Ph.D., Gustave Roussy Cancer Center. "In addition, this project incorporates a rigorous, clinically actionable framework to evaluate a novel approach to tumor-driven immune suppression and to rapidly generate translational insights that can inform future development and patient selection. On behalf of the consortium partners, we are excited to partner with Egle to advance this work and generate the clinical and translational evidence needed to bring new options like EGL-001 to patients."

About EGL-001
EGL-001 is an investigational anti-CTLA-4-IL-2m fusion protein designed to selectively disarm and remove regulatory T cells (Tregs) in the tumor microenvironment and to block CTLA-4 to help restore effector T-cell priming and function. This dual-target approach is intended to induce tumor-selective Treg apoptosis through an Fc receptor-independent mechanism, with the goal of strengthening anti-tumor immunity while supporting tolerability and use in combination regimens, including with PD-(L)1 inhibitors. EGL-001 is currently being evaluated in an ongoing multicenter, open-label, first-in-human Phase 1/2 clinical trial (NCT06622486) in patients with selected advanced and/or metastatic solid tumors, with dose escalation underway both as a single agent and in combination with an anti-PD-(L)1 therapy to assess safety, tolerability, and preliminary anti-tumor activity and to identify recommended doses for expansion.

(Press release, Egle Therapeutics, MAR 2, 2026, View Source [SID1234663202])

On March 2, 2026 Cerus Corporation (Nasdaq: CERS) reported financial results for its full year and fourth quarter ended December 31, 2025.

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"Our strong 2025 results reflect our disciplined execution, as we continued to deliver on our mission of safeguarding the world’s blood supply. This past year, we achieved our highest annual kit shipments, enabling an estimated 600,000 patients worldwide to receive INTERCEPT-treated blood components," said William "Obi" Greenman, Cerus’ president and chief executive officer. "This translated into record product revenue of over $206 million, a narrowing of our GAAP net loss, and positive non-GAAP adjusted EBITDA for the second consecutive year. Looking ahead to 2026, we remain focused on improving global access to our INTERCEPT technologies, advancing our product development programs and building upon the solid financial foundation we have established."

Additional highlights include:

Full-year 2025 and fourth-quarter 2025 total revenue comprised of (in millions, except percentages):
Three Months Ended

Twelve Months Ended

December 31,

Change

December 31,

Change

2025

2024

$

%

2025

2024

$

%

Product Revenue

$

57.8

$

50.8

$

7.0

14%

$

206.1

$

180.3

$

25.8

14%

Government Contract Revenue

6.8

5.9

0.9

15%

27.7

21.1

6.6

31%

Total Revenue

$

64.6

$

56.8

$

7.8

14%

$

233.8

$

201.3

$

32.5

16%

Numbers may not sum due to rounding. Percentages calculated from unrounded figures.

INTERCEPT Fibrinogen Complex (IFC) demand increased during the fourth quarter, with fourth quarter volumes – including kits and finished therapeutic doses (measured in FC15* equivalent units) – up over 50% compared to the prior year period. Fourth quarter U.S. IFC sales totaled $4.2 million, up from $3.0 million in the prior year period. For full year 2025, IFC demand more than doubled compared to 2024, while revenue increased approximately 80% to $16.7 million.
Entered into a group purchasing agreement with Blood Centers of America (BCA) during the fourth quarter, covering the Company’s licensed product portfolio. BCA is the largest blood supply cooperative in the U.S., with its member centers collecting and distributing approximately 50% of the nation’s blood supply.
Recently announced the start of the INITIATE study by the German Red Cross Blood Donation Service Baden-Württemberg – Hessen. INITIATE is a Phase 4 study evaluating the routine clinical use in Germany of pathogen-inactivated platelets utilizing the INTERCEPT Blood System.
Not including government grant revenue, the Company expects full-year 2026 product revenue to grow 9% to 11% year over year.
Cash, cash equivalents, and short-term investments were $82.9 million at December 31, 2025.
Revenue

Product revenue for the fourth quarter of 2025 was $57.8 million, compared to $50.8 million for the prior year period, representing year-over-year growth of 14%. Fourth quarter growth was primarily driven by strength in EMEA across the platelets franchise and continued rollout of INT200, as well as increased U.S. IFC sales. Product revenue for the full year 2025 was $206.1 million, compared to $180.3 million for the prior year, representing 14% growth. Full-year growth was driven by continued expansion of the Company’s global platelet products, increased U.S. IFC sales, and the launch of INT200 in EMEA.

Government contract revenue for the fourth quarter of 2025 was $6.8 million, compared to $5.9 million during the prior year period. Full year 2025 government contract revenue was $27.7 million, compared to $21.1 million during the prior year period. The increase in fourth quarter and full year government contract revenue was largely driven by BARDA-related projects.

Product Gross Profit and Margin

Product gross profit for the fourth quarter of 2025 was $29.7 million, increasing by 9% over the prior year period. Product gross margin for the fourth quarter of 2025 was 51.5% compared to 53.9% in the same period last year. Full-year 2025 product gross profit was $112.3 million, representing 13% growth compared to 2024. Full-year product gross margin was 54.5%, compared to 55.2% in the prior year. Higher IFC therapeutic production costs, ongoing trade regulation and inflationary pressures, as well as foreign exchange rates contributed to the change in product gross margin percentage compared to the prior year for both periods.

Operating Expenses

Total operating expenses for the fourth quarter of 2025 were $37.2 million, compared to $34.8 million in the same period of the prior year, representing a 7% year-over-year increase. For the full year 2025, total operating expenses were $148.6 million, compared to $134.8 million in 2024.

Research and development (R&D) expenses for the fourth quarter of 2025 were $16.4 million, compared to $15.4 million in the prior year period. For the full year 2025, R&D expenses totaled $67.7 million, compared to $58.9 million in 2024. Higher government contract costs and workforce-related costs contributed to the increase in R&D expenses for the fourth quarter. For the full year, the increase was driven by the same factors as well as increased development costs associated with the Company’s red blood cell and INT200 programs.

Selling, general, and administrative (SG&A) expenses for the fourth quarter of 2025 were $20.8 million, compared to $19.3 million in the prior year period. For the full year 2025, SG&A expenses totaled $80.9 million, compared to $75.9 million for the full year 2024.

Net Loss Attributable to Cerus Corporation

Net loss attributable to Cerus Corporation narrowed for the fourth quarter of 2025 and was $2.2 million, or $0.01 per basic and diluted share, compared to $2.5 million, or $0.01 per basic and diluted share, for the fourth quarter of 2024.

For the full year 2025, net loss attributable to Cerus Corporation was $15.6 million, or $0.08 per basic and diluted share, compared to $20.9 million, or $0.11 per basic and diluted share, in 2024.

Non-GAAP Adjusted EBITDA

Non-GAAP adjusted EBITDA for the fourth quarter of 2025 was $3.4 million, compared to $3.3 million for the fourth quarter of 2024. Full-year 2025 non-GAAP adjusted EBITDA was $9.5 million, compared to $5.7 million in 2024. For additional information, please see definitions and the reconciliation of this non-GAAP measure to net loss attributable to Cerus Corporation accompanying this release.

Balance Sheet and Cash Flows

At December 31, 2025, the Company had $82.9 million in cash, cash equivalents and short-term investments, compared to $80.5 million at December 31, 2024.

As of December 31, 2025, the Company had $65.0 million outstanding on its term loan and $19.0 million drawn on its revolving credit facility. The Company’s revolving line of credit allows for an additional $16.0 million as of December 31, 2025, which is dependent on eligible assets supporting the borrowing base.

For the fourth quarter of 2025, the Company generated $6.2 million in operating cash flow, compared to $4.9 million in the prior year period. The Company generated $8.1 million of operating cash flow in the second half of 2025 offsetting operating cash used during the first half of 2025. As a result, for the full year 2025, the Company generated $4.8 million in operating cash flow, compared to $11.4 million generated during 2024. These results were consistent with the Company’s previously communicated expectations which anticipated first-half cash use related to inventory investment, followed by stronger operating cash flow in the second half of 2025.

Reaffirming 2026 Product Revenue Guidance

The Company expects full-year 2026 product revenue to be in the range of $224 million to $228 million, representing year-over-year growth of 9% to 11% compared to 2025 product revenue. Included in the 2026 guidance range is expected full-year 2026 IFC revenue of $20 million to $22 million, representing year-over-year growth of approximately 20% to 30% from 2025.

Quarterly Conference Call

The Company will host a conference call at 4:30 P.M. ET this afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook. To listen to the live webcast, please visit the Investor Relations page of the Cerus website at View Source

A replay will be available on Cerus’ website approximately three hours after the call through March 23, 2026.

*FC15 equivalent to a therapeutic dose of a cryoAHF pool.

(Press release, Cerus, MAR 2, 2026, View Source [SID1234663171])

On March 2, 2026 Xoma Royalty presented its corporate presentation.

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(Presentation, Xoma, MAR 2, 2026, View Source [SID1234663187])

On March 2, 2026 Gyre Therapeutics, Inc. (Gyre or the Company) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic diseases, reported its agreement to acquire Cullgen Inc. (Cullgen), a privately-held, clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein degrader (TPD) and degrader antibody conjugate (DAC) therapies, in an all-stock transaction valued at approximately $300 million. Following the closure of the acquisition, the new combined entity will be a fully integrated biopharmaceutical company with U.S.- and China-based capabilities spanning from discovery to manufacturing and commercialization and covering multiple therapeutic areas including inflammatory diseases, cancers, and pain.

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Under the terms of the definitive agreement, Cullgen will become a wholly owned subsidiary of Gyre. Upon the completion of the acquisition, the interim Chief Executive Officer and Executive Chairman of Gyre, Ping Zhang, will remain as the Executive Chairman. The current Chief Executive Officer of Cullgen, Dr. Ying Luo, is expected to become the President and Chief Executive Officer and a member of the board of directors of Gyre.

Dr. Luo, the expected President and Chief Executive Officer of Gyre, commented, "We are thrilled about the synergistic coalescing of our companies. Cullgen brings strong drug discovery capabilities and a solid preclinical and clinical pipeline to complement Gyre’s existing and highly efficient China-based manufacturing capabilities and sales team. Gyre is already a commercial-stage company with ETUARY on the market in China for the treatment of lung fibrosis and a second product for liver fibrosis, Hydronidone (F351), nearing New Drug Application (NDA), submission in China. Gyre is also exploring the expansion of F351’s development in ex-China territories. Following the acquisition, we will have a fully integrated biopharmaceutical company that will be capable of leveraging emerging drug discovery capabilities in China and strong clinical development in the United States to address unmet medical needs worldwide. I am excited for the potential of TPDs and DACs to drive this Company’s future growth globally."

Mr. Zhang, Chairman of Gyre, commented, "Recently, Gyre, through its majority owned subsidiary, Gyre Pharmaceuticals, had a pre-NDA meeting with the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) which supported a conditional approval and priority review eligibility filing for Gyre Pharmaceuticals’ first-in-class anti-liver fibrosis candidate, Hydronidone, subject to formal approval. As a result, Gyre Pharmaceuticals plans to submit an NDA for Hydronidone for conditional approval in the first half of 2026 and conduct a Phase 3c confirmatory trial to support full approval in China. The addition of Cullgen’s TPD/DAC platform and pipeline is expected to enhance our long-term growth prospects. We are excited to have Cullgen colleagues join our team in both the United States and China."

The transaction is expected to close early in the second quarter of 2026, subject to customary closing conditions, including necessary regulatory approvals in the United States.

Prior to entering into this transaction, Cullgen’s proposed merger with Pulmatrix was terminated.

(Press release, Gyre Therapeutics, MAR 2, 2026, View Source [SID1234663203])

On March 2, 2026 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery powered by AI/ML, reported financial results for the fourth quarter and full year 2025 and provided a corporate update.

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"We delivered important progress in 2025, highlighted by the extension of our cash runway into 2029 through a non-dilutive monetization agreement with AstraZeneca for rilvegostomig," said Eran Ophir, Ph.D., President and CEO of Compugen. "This strategic transaction strengthens our cash position while preserving the potential for significant long-term value of a multi-billion-dollar asset being advanced by AstraZeneca across 10 Phase 3 clinical trials in lung, gastrointestinal and endometrial cancers with further clinical data anticipated from Phase 1/2 clinical trials in 2026."

Dr. Ophir continued, "Across our pipeline, we continue to execute with discipline. In 2025, we initiated dosing in new clinical trials of COM701 MAIA-ovarian and of GS-0321 Phase 1 and expanded our clinical footprint across the U.S., Israel and France in the MAIA-ovarian clinical trial. At ESMO (Free ESMO Whitepaper) 2025, we presented pooled COM701 data from 3 platinum resistant ovarian cancer trials that we believe support the rationale for our MAIA-ovarian trial, evaluating COM701 as maintenance therapy in platinum sensitive ovarian cancer in a setting of significant unmet medical need with no current standard of care. We are on track to have interim analysis in Q1 2027. In parallel, we are advancing our Phase 1 trial of GS-0321, an anti-IL18BP antibody licensed to Gilead which utilizes a differentiated cytokine-based approach. Additionally, we continue to invest in multiple early-stage discovery programs, advancing potential breakthrough drug candidates against undisclosed drug targets."

Dr. Ophir concluded, "We enter 2026 uniquely positioned with a strengthened balance sheet, a validated computational AI/ML discovery engine, a clinical pipeline built on differentiated innovative biology, enhanced leadership and two validating partnerships with AstraZeneca and Gilead representing up to $1 billion in potential milestone payments in addition to future royalties. I am incredibly proud of what our team has delivered and excited for what lies ahead."

Fourth Quarter and Full Year 2025 Financial Highlights
Cash: As of December 31, 2025, Compugen had approximately $145.6 million in cash, cash equivalents, short-term bank deposits and investment in marketable securities. The cash balance at the end of 2025 includes the receipt of the upfront payment of $65 million from AstraZeneca for the monetization of a small portion of rilvegostomig royalties.

Key Highlights from Royalty Monetization Deal with AstraZeneca:

•
$65 million upfront payment and $25 million added to the next potential milestone payment upon BLA acceptance, for a small portion of Compugen’s existing royalty interest in rilvegostomig
•
Compugen retains the majority of its future royalties and remains eligible for tiered royalties of up to mid-single digits on future sales and potential future regulatory and commercial milestones of up to $195 million (amount includes the $25 million stated above)

Compugen currently expects that its current cash balances will be sufficient to fund its operating plans into 2029. The Company has no debt.

Revenues: Compugen reported approximately $67.3 million in revenues for the fourth quarter of 2025 and approximately $72.8 million in revenues for the year ended December 31, 2025, compared to approximately $1.5 million in revenues for the fourth quarter of 2024 and approximately $27.9 million in revenues for the year ended December 31, 2024. The revenues for 2025 include the upfront payment of $65 million from AstraZeneca and the portion of the upfront payment and the IND milestone payment from the license agreement with Gilead, while the revenues for 2024 reflect the portion of the upfront payment and the IND milestone payment from the license agreement with Gilead and the $5 million clinical milestone payment from AstraZeneca.

Cost of Revenues for the fourth quarter and year ended December 31, 2025, were approximately $3.5 million and $9.3 million, respectively, compared with approximately $0.7 million and $7.9 million for the respective comparable periods in 2024. Cost of revenues for 2025 represents the cost of Phase 1 activities related to the license agreement with Gilead and royalties to the Israeli Innovation Authority (IIA) in connection with Compugen’s revenues from AstraZeneca, while cost of revenues for 2024 represents the cost of IND and Phase 1 activities related to the license agreement with Gilead and royalties to the IIA in connection with Compugen’s revenues from AstraZeneca, offset by royalty reversal in 2024 due to exemption received from the Israeli Innovation Authority from the requirement to pay royalties on income derived from potential sales associated with products related to IL-18BP.

R&D expenses for the fourth quarter and year ended December 31, 2025, decreased to approximately $5.5 million and $22.8 million, respectively, compared with approximately $5.9 million and $24.8 million for the comparable periods in 2024, respectively. The decrease in 2025 was mainly due to lower clinical expenses resulting from winding down prior clinical trials, partially offset by an increase in clinical expenses related to MAIA-ovarian trial initiated in 2025.

G&A expenses for the fourth quarter ended December 31, 2025, were approximately $2.1 million compared with approximately $2.2 million for the comparable period in 2024, and the G&A expenses for the year ended December 31, 2025, were approximately $8.9 million compared with approximately $9.4 million for the comparable period in 2024.

Net Income / Loss: During the fourth quarter of 2025, Compugen reported a net profit of approximately $56.8 million, or approximately 60 cents per basic and diluted share, compared to a net loss of approximately $6.1 million, or approximately 7 cents per basic and diluted share in the comparable period of 2024. Net profit for the year ended December 31, 2025, was approximately $35.3 million, or approximately 38 cents per basic and diluted share, compared with a net loss of approximately $14.2 million, or approximately 16 cents per basic and diluted share in the comparable period in 2024.

Full financial tables are included below.

Conference Call and Webcast Information
The Company will hold a conference call today, March 2, 2026, at 8:30 AM ET to review its fourth quarter and full year 2025 results. To access the conference call by telephone, please dial 1-866-744-5399 from the United States, or +972-3-918-0644 internationally. The call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.

(Press release, Compugen, MAR 2, 2026, View Source [SID1234663172])