On March 12, 2026 Cbio A/S reported that it has received regulatory clearance to begin a first-in-human Phase I/IIa clinical trial of novoleucel, the company’s next-generation T-cell therapy designed to improve immune cell function in cancer patients potentially leading to a more effective treatment.

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The study will enroll up to 20 patients with persistent or recurrent cervical cancer at Karolinska University Hospital in Stockholm, with the first patients expected to be treated within the coming months. Initial safety and translational data are expected by the end of 2026.

The milestone marks Cbio’s transition into clinical development and represents a key value inflection point for the company as it advances its strategy to improve the effectiveness of cell-based therapies in solid tumors.

"The regulatory clearance marks a defining milestone for Cbio," said Ulrik Cordes, Founder and CEO of Cbio. "Patients with recurrent cervical cancer have very limited treatment options once standard therapies fail. We believe that novoleucel has the potential to significantly transform the treatment landscape and are excited to begin evaluating this novel approach in patients."

Cervical cancer remains a major global health challenge, with more than 660,000 new cases diagnosed and 349,000 dying annually worldwide. The new cell-based therapy addresses a high unmet medical need for more effective treatment options.

Novoleucel is a first-in-class therapy designed to address the central challenge in cancer immunotherapy: oxidative stress within the tumor microenvironment that disables immune cells and limits therapeutic efficacy. The T-cells are armored to cope with this stress, increasing resistance to reactive oxygen species and helping preserve their cancer-killing activity inside tumors.

The therapy is based on discoveries from Professor Rolf Kiessling and Stina Wickström’s research group at Karolinska Institute, pioneers in adoptive cell therapy.

"For many years we have studied how oxidative stress suppresses immune cells in tumors," said Rolf Kiessling. "By protecting tumor-reactive T-cells through activation of the Nrf-2 pathway, we aim to improve their persistence and anti-tumor activity. It is very gratifying to see this concept now entering clinical testing."

The therapy will be manufactured at Cbio’s in-house GMP-certified cell therapy production facility in Copenhagen, Denmark, a 1,000 m² production facility dedicated to clinical-grade cell therapy manufacturing.

Cbio is supported by a syndicate of Nordic and international investors and is raising additional capital to support the expansion of the Phase I/IIa clinical program and to further develop its broader cell therapy platform.

"Seeing the program now enter clinical testing is both a proud moment and an important step forward for patients," said Cecilia Hultén, Co-Founder and CFO in Cbio. "The start of the clinical program represents an important value inflection point for the company," said Christian Leroy, board member and investor in Cbio. "We believe Cbio is advancing a compelling approach to improving cell therapies for solid tumors and look forward to following the development of novoleucel."

The ongoing financing will support expansion of the clinical program and the generation of initial safety and translational data expected by the end of 2026.

About the Clinical Trial (EUCT 2024-517594-24)

The Phase I/IIa study will evaluate novoleucel in patients with persistent or recurrent cervical cancer who have progressed after platinum-based chemotherapy and checkpoint inhibitors. The trial will assess safety, feasibility of manufacturing and delivery, persistence of infused T-cells, and early signals of clinical activity.

(Press release, CBio, MAR 12, 2026, View Source [SID1234663526])

On March 12, 2026 Champions Oncology, Inc. (Nasdaq: CSBR), a leading translational oncology research organization, reported its financial results for its third quarter of fiscal 2026, ended January 31, 2026.

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Third Quarter and Recent Highlights:

•Record study service revenue of $16.6 million, up approximately 32% year over year
•Total revenue of $16.6 million, compared to $17.0 million in the prior-year period
•Adjusted EBITDA of $574,000; GAAP loss from operations of approximately $276,000

The Company’s third quarter reflected record service revenue driven by strong study execution and the conversion of previously booked work. As is typical in the Company’s business, quarterly revenue can fluctuate depending on study timing and completion milestones. The strong third quarter reflects, in part, the conversion of backlog that had been delayed earlier in the year and may normalize somewhat in the near term before continuing to grow as bookings expand.

Robert Brainin, CEO of Champions, commented, "We delivered strong operational performance in the third quarter, including another quarter of record study services revenue and our third consecutive quarter of positive adjusted EBITDA. While quarterly results can fluctuate in our business, we remain on track for annual growth and full-year positive adjusted EBIDTA while continuing to invest in our data platform and discovery therapeutics initiatives. We are also encouraged by the early momentum we are beginning to see in our data business and remain confident that our differentiated tumor bank, expanding capabilities, and growing customer engagement position Champions well for long-term growth."

David Miller, CFO of Champions, added, "Study service revenue grew 32% year over year, benefiting in part from the conversion of previously booked work during the quarter. Total revenue declined modestly compared to the prior-year period due to the absence of the $4.5 million data license transaction recognized in the third quarter of last year."

"Cost of sales during the quarter included more than $2 million of outsourced radiolabeling work. As this work transitions in-house over time, we expect these costs to decline and margins to improve. We also continue to invest in both our commercial organization and our data platform capabilities to expand our pipeline of opportunities and support future growth."

Third Fiscal Quarter Financial Results

Total oncology revenue for the third quarter of fiscal 2026 was $16.6 million compared to $17.0 million for the same period last year, a decrease of 2.8%. The decline was primarily attributable to the absence of the $4.5 million data license revenue recognized in the third quarter of fiscal 2025. Excluding data, revenue increased 32% reflecting strong study execution and the conversion of bookings from earlier quarters into revenue during the third quarter.

Total costs and operating expenses for the third quarter of fiscal 2026 were $16.8 million compared to $12.5 million for the third quarter of fiscal 2025, an increase of $4.3 million or 34.3%.

For the third quarter of fiscal 2026, Champions reported a net loss of $279,000, including $423,000 in stock-based compensation, $341,000 in depreciation and amortization expenses, and a loss on equipment sale and disposal of $89,000 . This compares to net income of $4.5 million in the third quarter of fiscal 2025, which included $256,000 in stock-based compensation and $398,000 in depreciation and amortization expenses. Adjusted EBITDA, which is defined as net income excluding stock-based compensation, depreciation and amortization expenses, and a loss on the sale and / or disposal of lab equipment was $574,000 for the third quarter of fiscal 2026 compared to adjusted EBITDA of $5.1 million in the third quarter of fiscal 2025.

Cost of oncology revenue was $8.8 million, for the three months ended January 31, 2026, an increase of $2.2 million, or 33.5%, compared to $6.6 million in the same quarter of fiscal 2025. The increase was primarily driven by higher outsourced lab service costs. As the Company transitions more of this work in-house, management expects margins to improve. Oncology services margin for the quarter was 47%, compared to 61% for three months ended January 31, 2025. The margin decline reflects outsourced radiolabeling work as well as the contribution of high-margin data revenue recognized in the prior-year period. Oncology services margin and profit are defined below in our Non-GAAP financial information discussion.

Research and development expense for the three months ended January 31, 2026 was $2.3 million, an increase of $552,000 or 32.1%, compared to $1.7 million for the three months ended January 31, 2025. The increase reflected greater investment in sequencing and related activities to advance the Company’s data licensing platform. Sales and marketing expense for the quarter was $2.7 million, an increase of $860,000, or 47.6%, compared to $1.8 million in the prior year period, driven primarily by higher compensation expense to support the growth of both the data and commercial businesses. General and administrative expense for the three months ended January 31, 2026 was $3.0 million, an increase of $0.6 million, or 24.1%, compared to $2.4 million for the three months ended January 31, 2025. The increase was primarily due to higher compensation expense, including stock-based compensation, and increased IT-related costs.Net cash used in operating activities was approximately $1.4 million for the three months ended January 31, 2026, primarily driven by an increase in accounts receivable and a decline in deferred revenue partially offset by an increase in accounts payable. Net cash used in financing and investing activities totaled approximately $30,000, reflecting purchases of lab and computer equipment, repayment of financing leases, and a stock options exercise.

The Company ended the quarter with cash on hand of approximately $7.1 million and no debt.

Year-to-date Financial Results

Total revenue for the nine months ending January 31, 2026 was $45.6 million, compared to $44.6 million for the same period last year, an increase of 2.2%. Total costs and operating expenses for the nine months ending January 31, 2026 were $46.2 million, compared to $38.0 million for the nine months ending January 31, 2025, an increase of $8.2 million, or 21.5%.

For the nine months ending January 31, 2026, Champions reported a net loss of $508,000, including $880,000 in stock-based compensation, $1.1 million in depreciation and amortization expenses, and a loss on the sales and disposal of equipment of $110,000. This compares to net income of $6.6 million in the nine months ending January 31, 2025, which included $523,000 in stock-based compensation and $1.2 million in depreciation and amortization expenses. Excluding stock-based compensation, depreciation and amortization, and an equipment disposal and sale losses, adjusted EBITDA was $1.5 million for the nine months ending January 31, 2026, compared to $8.3 million in the nine months ending January 31, 2025.

Cost of oncology services was $24.1 million for the nine months ended January 31, 2026, an increase of $3.0 million, or 14.1%, compared to $21.1 million for the same period in 2025. The increase was primarily driven from higher mice costs and outsourced lab services. Oncology services margin for current year period was 47% compared to 52.6% for the prior year period.

Research and development expense for the nine months ended January 31, 2026 was $7.0 million, an increase of $2.1 million, or 43.3%, compared to $4.9 million for the same period in 2025. The increase was primarily driven by greater investment in sequencing and related costs to support the development of our data platform, as well as an increase in investment in Corellia. Sales and marketing expense for the nine months ended January 31, 2026 was $6.5 million, an increase of $1.3 million, or 24.5%, compared to the prior-year period. General and administrative expense was $8.5 million, an increase of $1.7 million, or 25.0%, compared to $6.8 million for the nine months ended January 31, 2025.

Conference Call Information:
The Company will host a conference call today at 4:30 p.m. EDT (1:30 p.m. PDT) to discuss its third quarter financial results. To participate in the call, please call 888-506-0062 (Domestic) or 973-528-0011 (International) and enter the access code 957548, or provide the verbal reference "Champions Oncology".
Full details of the Company’s financial results will be available on or before March 16, 2026 in the Company’s Form 10-Q at www.championsoncology.com.

(Press release, Champions Oncology, MAR 12, 2026, View Source [SID1234663492])

On March 12, 2026 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a novel class of custom-built protein drugs known as DARPin therapeutics ("Molecular Partners" or the "Company"), reported its corporate highlights and audited financial results for the full year 2025, as well as the publication of its 2025 Annual Report.

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"We are making significant progress in targeted alpha radiotherapy, as our first Radio-DARPin candidate, MP0712 targeting DLL3, enters clinical development. Early imaging and dosimetry results support the ongoing Phase 1/2a study for MP0712, which aims to address critical needs in lung cancer treatment," said Patrick Amstutz, Ph.D., CEO of Molecular Partners. He added: "We are strengthening our expertise with a strong scientific advisory board, chaired by Prof. Ken Herrmann, to support our growing Radio-DARPin pipeline, with MP0726 moving towards imaging and new candidates being selected. Our solid finances position us well for future growth."

Research & Development Highlights

MP0712 & Radio-DARPin Pipeline

The MP0712 Phase 1/2a trial has started (ClinicalTrials.gov: NCT07278479) and recruitment is open. MP0712 is the Company’s lead Radio-DARPin Therapy (RDT) targeting the tumor-associated protein delta-like ligand 3 (DLL3) and carrying the therapeutic payload 212Pb. It is being developed with Molecular Partners’ strategic partner Orano Med, a pioneer in targeted alpha therapy, for the treatment of patients with small cell lung cancer (SCLC) and other neuroendocrine cancers. The Phase 1/2a study is a multi-center study in the US, with the objectives to assess safety and determine a recommended Phase 2 dose for MP0712. The study contains a pre-treatment imaging and dosimetry step with 203Pb-labeled MP0712. The Company expects initial clinical data from this study in 2026.

Molecular Partners and the NuMeRI team presented first patient imaging and dosimetry data on MP0712 at the 8th Theranostics World Congress (TWC) in January 2026. The data from five evaluable patients with various DLL3-expressing cancers, including small cell lung, urothelial, and other neuroendocrine cancers, were generated with MP0712 carrying the diagnostic isotope 203Pb under the leadership of Dr. Mike Sathekge as part of a Named Patient Access Program under the legal framework for compassionate care in South Africa (also referred to as Section 21 of the Medicines and Related Substances Act). The images show specific uptake as well as robust accumulation of MP0712 in tumor lesions, with limited uptake in healthy tissues, as intended, confirming the initial data on MP0712 presented at the Targeted Radiopharmaceuticals (TRP) Summit Europe 2025. MP0712 is half-life engineered to promote tumor uptake over time via the DLL3 internalization and replenishment mechanism. The biodistribution and dosimetry extrapolations are supportive of the Phase 1/2a study design and of the clinical development plans of MP0712 carrying the therapeutic isotope 212Pb for patients with small cell lung cancer (SCLC) and other DLL3-expressing neuroendocrine cancers.

The Company’s second RDT program MP0726, co-developed with Orano Med, targets mesothelin (MSLN), a tumor target overexpressed across several cancers with high unmet need, such as ovarian cancer. Molecular Partners has developed Radio-DARPins able to selectively bind to membrane-bound MSLN without being impacted by shed MSLN – a mechanism which has hampered the development of other MSLN-targeting therapeutics. The Company presented preclinical data on MP0726 at the 2025 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI). The Company is planning to progress several Radio-DARPin programs towards first-in-human imaging, including MP0726.

For its growing Radio-DARPin pipeline and based on the first-in-human Radio-DARPin data presented at TWC 2026 indicating that Radio-DARPins may be suitable vectors for alpha-emitting isotopes, including 212Pb and also the longer-lived 225Ac, Molecular Partners is evaluating various radio-nuclides moving forward to tailor Radio-DARPin candidates to patient needs – matching vector and isotope properties with target and disease biology. Molecular Partners entered a non-exclusive development agreement with Eckert & Ziegler for targeted alpha radio-therapeutics, thereby enabling the potential of Radio-DARPins for a range of therapeutic isotopes, including 225Ac, and advancing the Company’s wholly owned pipeline. The Company plans to present pre-clinical data on Radio-DARPins suitability with multiple isotopes at the 3rd Global Radiopharmaceuticals Development Summit in March 2026 in Shanghai, China.

In December 2025 Molecular Partners announced the formation of a scientific advisory board (SAB) to accelerate the development of its targeted radiotherapeutics. The SAB, chaired by well-known nuclear medicine expert Prof. Ken Herrmann, will be instrumental in guiding Molecular Partners strategic direction as it transitions and evolves from early clinical validation to full clinical development of its targeted alpha radiotherapies.

Molecular Partners’ Radio-DARPins are designed as ideal vectors for precise delivery of potent alpha-emitting isotopes to tumor lesions with the potential to unlock a broad range of solid tumor targets for radiopharmaceuticals.

MP0317 (tumor-localized CD40 agonist)

An investigator-initiated, proof-of-concept Phase 2 study of MP0317 combined with standard-of-care (SoC) for the treatment of patients with advanced cholangiocarcinoma is now open with two sites activated (NCT07036380) and patient dosing ongoing. The study is a randomized, multicenter study in France and aims to recruit 75 patients (with a 2to1 design, including 50 patients in the experimental arm, and 25 in the control arm). The objective of the study is to assess the clinical benefit of MP0317 combined with SoC comprising the immunotherapy durvalumab, an anti-PD-L1 checkpoint inhibitor, plus gemcitabine-cisplatin-based chemotherapy, compared to SoC alone. The tumor microenvironment (TME) is known to play a crucial role in cholangiocarcinoma development and treatment resistance. MP0317 is hypothesized to lead to immune-mediated reshaping of the TME, thereby improving the 12-month progression-free survival rate of patients compared to those treated with SoC only.

MP0317 is designed to activate immune cells specifically within the TME by anchoring to fibroblast activation protein (FAP), which is expressed in high amounts in the stroma of various solid tumors, including cholangiocarcinoma. The Company completed a Phase 1 dose-escalation study of MP0317 in patients with advanced solid tumors in 2024 (NCT05098405; 46 patients treated across 9 dose levels). Comprehensive biomarker analyses from this trial showed tumor-localized CD40 activation and remodeling of the TME. CD40 is an attractive target for cancer immunotherapy due to its strong immune-stimulatory activity. Molecular Partners believes that MP0317’s tumor-localized approach has the potential to deliver superior efficacy with fewer side effects compared to systemic CD40 agonists.

MP0533 (multispecific T cell engager)

MP0533 is currently being evaluated in a Phase 1/2a clinical trial for relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome/AML (NCT05673057).

Data presented at the 2025 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting showed that densified dosing appears tolerable, and leads to markedly improved serum exposure in cycle 1, along with antitumor activity, in particular in patients with low bone marrow blast count at baseline. Cohort 10 is currently dosing patients and an update on this study is expected in H1 2026.

Molecular Partners plans to support the exploration of MP0533 in combination, both in patients with relapsed/refractory disease as well as in front-line, and has been approached by several consortia expressing interest in conducting such studies. The Company is actively engaging with key opinion leaders and regulators to shape the next phase of development, and anticipates updating the clinical plan for MP0533 in H1 2026.

MP0533 is a novel tetra-specific T cell-engaging DARPin designed for selective and broad killing of AML cells in a mutation-agnostic manner. MP0533’s mode of action enables T cell-mediated killing of AML cells – which commonly co-express at least two of the three targeted antigens (CD33, CD123, CD70) – while preserving a therapeutic window that minimizes damage to healthy cells, which normally express one or none of the targets.

Switch-DARPin Platform (next-generation immune cell engagers)

Molecular Partners designed a logic-gated Switch-DARPin T-cell engager (TCE) to achieve conditional tumor-localized immune activation targeting MSLN and epithelial cell adhesion molecule (EpCAM), which are highly co-expressed in ovarian cancer and other solid tumors. The Switch-DARPin TCE is designed to unmask the CD3-engaging DARPin ("Switch" on) and to activate T cells only upon binding to both MSLN and EpCAM. Co-engagement of CD2 leads to sustained T-cell activation and cytotoxic capacity, enabling the development of potent TCEs with an improved therapeutic window. This Switch-DARPin is half-life extended through a Fc domain, which broadens the Company’s capabilities in half-life engineering modalities.

Based on the encouraging pre-clinical data presented at the 2025 Annual Meetings of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) and the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), the Company intends to nominate a lead Switch-DARPin candidate for development in H1 2026 and will provide an update on the program at AACR (Free AACR Whitepaper) 2026.

Corporate Governance & Leadership Highlights

Molecular Partners appointed Martin Steegmaier, Ph.D., as Chief Scientific Officer (CSO) and member of its Executive Committee, effective October 1, 2025. Martin brings a wealth of experience in oncology drug development, having previously contributed to the advancement of several innovative cancer therapies at major biotech and pharmaceutical companies.

In 2025 Molecular Partners performed a strategic review of its operations and headcount, with the objectives of increased efficiency in the organization and to sharpen the focus on advancing its clinical assets.

In April 2025, all motions proposed by the Board of Directors at the Annual General Meeting were approved by the shareholders of the Company by a wide majority.

2025 Financial Highlights

In the financial year ended December 31, 2025, Molecular Partners recognized no revenue (2024: CHF 5.0 million) and incurred total operating expenses of CHF 58.1 million (2024: CHF 66.2 million). This led to an operating loss of CHF 58.1 million for 2025 (2024: Operating loss of CHF 61.2 million).

The net financial loss recorded in 2025 was CHF 3.5 million, compared to a net financial gain of CHF 7.2 million in 2024. This resulted in a 2025 net loss of CHF 61.7 million (2024: Net result of CHF 54.0 million).

The net cash used in operating activities in 2025 was CHF 51.3 million (2024: Net cash used in operating activities CHF 59.2 million). Including short-term time deposits, the cash and cash equivalents position decreased by CHF 56.3 million as compared to year-end 2024, to CHF 93.1 million as of December 31, 2025 (December 31, 2024: CHF 149.4 million). Total shareholders’ equity stood at CHF 80.3 million as of December 31, 2025, a decrease of CHF 61.3 million (December 31, 2024: CHF 141.6 million).

The Company’s cash and cash equivalents and short-term time deposits were CHF 93.1 million as of December 31, 2025, and based on current operating assumptions, will be sufficient to fund its operating expenses and capital expenditure requirements until 2028.

The Company’s balance sheet remained debt-free as of December 31, 2025. As of December 31, 2025, the Company employed 134.0 FTE (full-time equivalents). About 81% of the employees are employed in R&D-related functions.

Key figures as of December 31, 2025

Key Financials (CHF million, except per share, FTE data) FY 2025 FY 2024 Change
Total revenues and other income — 5.0 (5.0 )
R&D expenses (40.2 ) (48.6 ) 8.4
SG&A expenses (15.2 ) (17.6 ) 2.4
Restructuring expenses (2.7 ) — (2.7 )
Total operating expenses (incl depr. & amort.) (58.1 ) (66.2 ) 7.9
Operating result (58.1 ) (61.2 ) 3.1
Net finance result (3.5 ) 7.2 (10.7 )
Net result (61.7 ) (54.0 ) (7.6 )
Basic net result per share (in CHF) (1.65 ) (1.59 ) 0.30
Net cash (used in) from operating activities (51.3 ) (59.2 ) 7.9
Cash & cash equivalents (incl. short-term time deposits) 93.1 149.4 (56.3 )
Total shareholders’ equity 80.3 141.6 (61.3 )
Number of total FTE 134.0 158.5 (24.5 )

Financial outlook 2026

For the full year 2026, at constant exchange rates, the Company expects total operating expenses of CHF 45-55 million, of which around CHF 6 million will be non-cash effective costs for share-based payments, IFRS pension accounting and depreciation.

Documentation

This press release, the Company’s Annual Report on Form 20-F for the year ended December 31, 2025 to be filed with the U.S. Securities and Exchange Commission (SEC), and the Company’s annual report 2025 will be made available through www.molecularpartners.com under the investor section after 10.00 pm CET (4.00 pm EST) on March 12, 2026.

Financial calendar

April 14, 2026 Annual General Meeting
May 12, 2026 Interim Management Statement Q1 2026
August 25, 2026 Half-year results 2026 (unaudited)
October 29, 2026 Interim Management Statement Q3 2026

The latest timing of the above events can always be viewed on the investor section of the website.

(Press release, Molecular Partners, MAR 12, 2026, View Source [SID1234663511])

On March 12, 2026 Gyre Therapeutics (Gyre or the Company) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic disease, reported financial results for the fourth quarter and full year ended December 31, 2025 and provided a business update.

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"2026 is expected to be a pivotal regulatory year for Gyre as we advance Hydronidone toward conditional approval in China following our alignment with China’s CDE," said Ping Zhang, Executive Chairman and Interim Chief Executive Officer of Gyre Therapeutics. "Our planned NDA submission in the first half of 2026 underscores the strength of our Phase 3 data and the constructive progress achieved through regulatory engagement. In addition, we have completed enrollment in our 52-week Phase 3 pirfenidone trial in pneumoconiosis, further strengthening our late-stage respiratory portfolio. We have also incorporated the complete Phase 2 and Phase 3 clinical data from our CHB-associated liver fibrosis program into our U.S. development strategy and expect to submit an IND application in 2026 for MASH-associated liver fibrosis. Finally, we recently announced an agreement to acquire Cullgen, a company with a robust pipeline of degraders, targeting inflammatory diseases and cancers, as well as U.S.-based drug discovery and development capabilities. Collectively, these achievements support the continued advancement of our differentiated pipeline across both China and the United States."

Fourth Quarter 2025 Business Highlights and Upcoming Milestones

Commercial Portfolio

ETUARY (pirfenidone): Generated $106.1 million in sales of ETUARY for the full year ended December 31, 2025, compared to $105.0 million for the same period in 2024.
Etorel (nintedanib ethanesulfonate soft capsules): Launched in June 2025 and generated $4.6 million in sales for the full year ended December 31, 2025.
Contiva (avatrombopag maleate tablets): Launched in March 2025 and generated $5.5 million in sales for the full year ended December 31, 2025.
Pipeline Development Updates

Hydronidone:

In November 2025, Gyre Pharmaceuticals Co., Ltd. (Gyre Pharmaceuticals) presented positive Phase 3 trial results evaluating Hydronidone for the treatment of liver fibrosis in chronic hepatitis B (CHB)-associated liver fibrosis at The Liver Meeting 2025, the annual meeting of the American Association of the Study of Liver Diseases. The abstract was selected as a Poster of Distinction.
Following the Phase 3 trial results, Gyre Pharmaceuticals completed a Pre-NDA meeting with China’s CDE. Based on the discussions, the CDE indicated that the existing Phase 3 clinical data support a conditional approval filing and potential priority review eligibility, subject to formal acceptance and approval. The Company plans to submit an NDA for conditional approval in the first half of 2026.
In the United States, Gyre Therapeutics plans to conduct a hepatic impairment study under its active U.S. IND application to inform dose selection and enrollment criteria in patients with reduced hepatic function, supporting the Company’s broader U.S. development strategy.
Gyre Therapeutics remains on track to submit an IND application in 2026 with the U.S. Food & Drug Administration for Hydronidone in MASH-associated liver fibrosis, and, subject to IND clearance, initiate a Phase 2 clinical trial.
Pirfenidone:

In the third quarter of 2025, Gyre Pharmaceuticals completed patient enrollment in its 52-week Phase 3 clinical trial evaluating pirfenidone for the treatment of PD. The multicenter, randomized, double-blind, placebo-controlled trial enrolled 272 patients across 18 clinical research centers in China and is designed to assess the efficacy and safety of 52 weeks of pirfenidone treatment in patients with this chronic occupational lung disease characterized by progressive pulmonary fibrosis. The final patient is expected to complete the trial in the third quarter of 2026.
Following approval in March 2025 from China’s National Medical Products Association’s (NMPA) for a clinical trial evaluating pirfenidone in oncology-related pulmonary complications, Gyre Pharmaceuticals plans to initiate an adaptive Phase 2/3 trial in the first half of 2026 in China. This trial will evaluate pirfenidone for radiation-induced lung injury (RILI), including cases complicated by immune-related pneumonitis, at leading oncology centers.
Corporate Updates:

In March 2026, Gyre announced an agreement to acquire Cullgen Inc. (Cullgen), a privately-held, clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein degrader and degrader antibody conjugate therapies, in an all-stock transaction valued at approximately $300 million. Following the closing of the acquisition, expected in the second quarter of 2026, the new combined entity is expected to 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.
Financial Results

Cash Position

As of December 31, 2025, Gyre had cash, cash equivalents, short-term and long-term bank deposits of $75.9 million.

Financial Results for the Three Months Ended December 31, 2025

Revenues: Revenues for the three months ended December 31, 2025 were $37.2 million, compared to $27.9 million for the same period in 2024, representing an increase of $9.3 million, or 33.3% year-over-year. The growth was driven by $1.5 million in Etorel sales and $2.5 million in Contiva sales, as well as a $5.5 million increase in ETUARY sales, partially offset by a $0.2 million decrease in generic drug revenue. The increase in ETUARY sales reflects strengthened commercial execution and the reallocation of marketing resources during the second half of 2025.
Cost of Revenues: For the three months ended December 31, 2025, cost of revenues was $1.7 million, compared to $1.2 million for the same period in 2024. The $0.5 million increase was primarily driven by a $0.4 million increase in stock-based compensation expense, and a $0.1 million increase in cost of sales of Etorel and Contiva.
Selling and Marketing Expense: Selling and marketing expense for the three months ended December 31, 2025 was $23.8 million, compared to $16.9 million for the same period in 2024, representing an increase of $6.9 million, or 40.8% year-over-year. The increase was primarily attributable to expanded commercial activities, including a $2.9 million increase in personnel costs driven by higher sales headcount and commissions, a $2.2 million increase in stock-based compensation expense, a $1.7 million increase in conference and promotional activities, and a $0.1 million increase in travel and other expenses.
Research and Development Expense: For the three months ended December 31, 2025, research and development expense was $4.8 million, compared to $3.7 million for the same period in 2024. The $1.1 million increase was primarily driven by a $0.6 million increase in facilities, depreciation and other expenses, attributable mainly to professional and consulting fees incurred in connection with research and development operations, a $0.3 million increase in pre-clinical research costs, a $0.2 million increase in clinical trial costs and a $0.3 million increase in staff costs which included $0.2 million in stock-based compensation expenses, partially offset by a $0.3 million decrease in materials and utilities expenses.
General and Administrative Expense: For the three months ended December 31, 2025, general and administrative expense was $6.7 million, compared to $5.5 million for the same period in 2024. The $1.2 million increase was primarily driven by a $1.2 million increase in stock-based compensation expense and a $0.8 million increase in functional and administrative department’s personnel expense, partially offset by a $0.6 million decrease in professional service expense, a $0.1 million decrease in depreciation and amortization expense and a $0.1 million decrease in miscellaneous expense.
Income from Operations: For the three months ended December 31, 2025, income from operations was $0.1 million, compared to $0.7 million income from operations for the same period in 2024. The $0.6 million decrease in income from operations was driven primarily by a $9.9 million increase in total operating expenses, partially offset by a $9.3 million increase in revenue.
Net (Loss) Income: For the three months ended December 31, 2025, net loss was $1.4 million, compared to $0.6 million net income for the same period in 2024. The $2.0 million decrease was driven primarily by an increase in income tax expense of $1.1 million, an increase in operating expenses of $9.9 million and a decrease in other income of $0.3 million, partially offset by an increase in revenue of $9.3 million.
Non-GAAP Adjusted Net Income: For the three months ended December 31, 2025, non-GAAP adjusted net income was $4.3 million, compared to $1.1 million for the same period in 2024. The $3.2 million increase was primarily driven by an increase in revenue of $9.3 million partially offset by the increase in operating expenses of $5.8 million and an decrease in other income of $0.3 million.
Financial Results for the Full Year Ended December 31, 2025

Revenues: Revenues for the full year ended December 31, 2025 were $116.6 million, compared to $105.8 million for the same period in 2024, representing an increase of $10.8 million, or 10.2% year-over-year. The growth was driven by $5.5 million in Contiva sales and $4.6 million in Etorel sales, along with a $1.1 million increase in ETUARY sales, partially offset by a $0.4 million decline in generic drug revenue.

Sales of Contiva and Etorel, which commenced commercialization in March 2025 and June 2025, respectively, were primarily driven by the targeted allocation of commercial and marketing resources to support their respective launches during the first half of 2025. The increase in ETUARY sales reflects a strategic realignment of marketing efforts in the third quarter of 2025 to optimize product mix and address evolving market dynamics.
Cost of Revenues: For the full year ended December 31, 2025, cost of revenues was $5.4 million, compared to $3.9 million for the same period in 2024. The $1.5 million increase was primarily driven by a $0.8 million increase in ETUARY’s cost, due to higher plant, property and equipment depreciation from a plant renovation completed in the second half of 2024, a $0.6 million increase in the cost of Contiva and Etorel, in line with the corresponding increase in their sales, and a $0.5 million increase in stock-based compensation expense. These factors were partially offset by a $0.4 million decrease in costs related to generic drugs due to the decrease in sales.
Selling and Marketing Expense: For the full year ended December 31, 2025, selling and marketing expense was $65.2 million, compared to $57.5 million for the same period in 2024. This $7.7 million increase was primarily driven by a $2.5 million increase in conference expenses and promotional expenses, attributable to the launch of additional promotional campaigns in the current year—particularly for the Company’s new products, a $2.6 million increase in staff costs, which was driven by expanded headcount and higher sales commissions, consistent with the corresponding growth in revenue, a $2.3 million increase in stock-based compensation expense and a $0.3 million increase in traveling and other expense.
Research and Development Expense: For the full year ended December 31, 2025, research and development expense was $13.7 million, compared to $12.0 million for the same period in 2024. The $1.7 million increase was attributable to a $1.0 million increase in clinical trial costs, primarily as a result of data analysis costs for Hydronidone, PD and RILI, a $0.4 million increase in staff costs, which included $0.2 million in stock-based compensation expense, a $0.5 million increase in facilities, depreciation and other expenses, attributable mainly to professional and consulting fees incurred in connection with research and development operations, and a $0.4 million increase in pre-clinical research expenses. These expense increases were partially offset by a $0.6 million decrease in materials and utilities expenses.
General and Administrative Expense: For the full year ended December 31, 2025, general and administrative expense was $20.8 million, compared to $16.1 million for the same period in 2024. This $4.7 million increase was primarily driven by a $3.3 million increase in stock-based compensation expense, a $1.3 million increase in functional and administrative department’s personnel expense, and a $0.9 million increase in miscellaneous expense. These cost increases were partially offset by a $0.8 million decrease in professional service expenses.
Income from Operations: For the full year ended December 31, 2025, income from operations was $11.5 million, compared to $16.2 million in income for the same period in 2024. The $4.7 million decrease in income from operations was driven primarily by a $15.5 million increase in total operating expenses, partially offset by a $10.8 million increase in revenue.
Net Income: For the full year ended December 31, 2025, net income was $9.9 million, compared to $17.9 million net income for the same period in 2024. This $8.0 million decrease was driven primarily by the increase in operating expenses of $15.5 million and decrease in change in fair value of warrant liability of $4.5 million, partially offset by an increase in revenue of $10.8 million, an increase in other income of $0.4 million, and a decrease in income tax expense of $0.8 million.
Non-GAAP Adjusted Net Income: For the full year ended December 31, 2025, non-GAAP adjusted net income was $18.9 million, compared to $16.9 million for the same period in 2024. The increase was primarily driven by an increase in revenue of $10.8 million and an increase in other income of $0.4 million partially offset by an increase in operating expenses of $9.2 million.
Full Year 2026 Financial Guidance

For the full year 2026, the Company expects to generate revenues of $100.5 million to $111.0 million, representing a decline of approximately 13.8% to 4.8% compared to 2025.

The Company anticipates that 2026 will be a transition period, during which it plans to prioritize regulatory activities, including preparation for the planned NDA submission of Hydronidone.

In addition, given uncertainties associated with the National Centralized Drug Procurement program and evolving market dynamics, the Company expects to moderate promotional activities for Contiva and Etorel.

Please note the following regarding the total revenue guidance:

Guidance assumes a constant foreign currency exchange rate.
Guidance assumes no significant economic disruption or downturn.

(Press release, Gyre Therapeutics, MAR 12, 2026, View Source [SID1234663527])

On March 12, 2026 Circle Pharma, Inc., a clinical-stage biopharmaceutical company pioneering next-generation targeted macrocycle therapeutics for cancer, reported publication of research in the Journal of Medicinal Chemistry titled, "Orally Bioavailable Cyclin A/B RxL Inhibitors: Optimization of a Novel Class of Macrocyclic Peptides That Target E2F-High and G1-S-Checkpoint-Compromised Cancers." The paper is included in the journal’s special issue on Peptide Therapeutics.

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The publication builds on the company’s August 2025 Journal of Medicinal Chemistry paper titled, "Discovery of Cell-Permeable Macrocyclic Cyclin A/B RxL Inhibitors that Demonstrate Antitumor Activity," which described the first cell-permeable macrocyclic cyclin A/B RxL inhibitors and provided initial in vivo proof-of-concept efficacy.

"This publication demonstrates the capability of our MXMO macrocycle platform to bring forward orally bioavailable macrocycles against therapeutic targets that have been refractory to small molecule chemistry," said James Aggen, Ph.D., vice president of medicinal chemistry at Circle Pharma. "Our earlier work established that the cyclin A/B hydrophobic patch was druggable with macrocycles. This new research demonstrates these molecules can be delivered orally with compelling in vivo activity."

Cyclins A and B regulate cell cycle progression by recruiting substrates through an RxL-mediated interaction. In cancers characterized by RB1 loss or elevated E2F activity – including nearly all small-cell lung cancers – this pathway becomes dysregulated, driving uncontrolled tumor growth. Rather than inhibiting CDK catalytic activity, Circle Pharma’s approach disrupts the protein-protein interactions between cyclins A and B and their RxL-containing substrates, selectively killing E2F-high tumor cells.

CID-078, Circle Pharma’s oral cyclin A/B RxL inhibitor is currently being evaluated in a multi-center Phase 1 clinical trial in patients with advanced solid tumors (NCT06577987).

(Press release, Circle Pharma, MAR 12, 2026, View Source [SID1234663493])