On March 13, 2026 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for noninvasive, accurate tests for the detection of early-stage lung cancer and other lung diseases, reported financial results for the year ended December 31, 2025.

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2025 Highlights

● Record CyPath Lung Revenue and Unit Sales. Revenue from our noninvasive diagnostic for lung cancer increased 87% over 2024 with the number of tests performed rising 99% year over year, reflecting growing clinical utilization and validating the first phase of our commercialization strategy. The Company’s strategic decision to discontinue unprofitable pathology services and reallocate resources to the commercialization of CyPath Lung led to a 34% decrease in total revenue and a 9% decrease in operating expenses compared to 2024, respectively.

● Expanded Physician Network. The number of physician offices and clinics ordering CyPath Lung for their patients increased 67% over 2024. We expect the trend to accelerate in 2026 as we expand our sales force into new markets. Peer-to-peer physician engagement remains a key driver of growth. Compelling patient case studies and key opinion leaders (KOLs) who are sharing their clinical experience are building awareness and clinical adoption of CyPath Lung.

● Leadership Appointments. Gordon Downie, MD, PhD, joined bioAffinity Technologies as Chief Medical Officer, bringing more than three decades of experience in pulmonary medicine, clinical research, medical innovation, and interventional pulmonology to the role. Roberto Rios, CPA, and John J. Oppenheimer, MD, were appointed to the Board of Directors in 2025. Mr. Rios has more than four decades of executive leadership experience in corporate finance and governance across industries including biotechnology and medical devices. Dr. Oppenheimer is a recognized leader in the diagnosis and treatment of asthma and COPD and directs clinical research in lung health while also teaching at the University of Medicine and Dentistry of New Jersey-Rutgers.

● Successful Financings. The Company raised approximately $16.9 million in gross proceeds during 2025 from equity transactions to fund CyPath Lung clinical development, commercialization, and operational expansion.

● CyPath Lung-Centered Performance. Through targeted operational streamlining and the discontinuation of certain unprofitable pathology services at our laboratory, Precision Pathology Laboratory Services (PPLS), we positioned CyPath Lung as the core driver of long-term shareholder value. While these actions contributed to lower consolidated revenue in the short term, they improved operating focus and cost structure and are intended to position our noninvasive lung cancer diagnostic for scalable growth and improved long-term margin potential.

● Innovation Pipeline Progress. Research and development continued on diagnostic tests for chronic obstructive pulmonary disease (COPD) and asthma that build on our expertise in using sputum as a sample for flow cytometric analysis. Research is focused on detecting specific receptors in sputum to guide personalized treatment and identify patients likely to benefit from emerging targeted therapies. Asthma and COPD impact approximately 650 million children and adults globally.1 We expect to begin patient studies in 2026.

● Expanded Global Intellectual Property Portfolio. During 2025, we strengthened our intellectual property portfolio supporting CyPath Lung and our broader flow cytometry platform through multiple patent allowances and acceptances. These included notification of allowance from the U.S. Patent and Trademark Office for our diagnostic algorithm and test method, patent allowances in Canada and China covering flow cytometry-based lung cancer detection methods, and acceptance of patent applications in Australia related to early-stage lung cancer detection and multi-disease lung health assessment. These developments further expand international protection of our diagnostic technology and support our long-term commercialization strategy.

Management Commentary

"2025 was a transformational year for bioAffinity Technologies. We took deliberate actions to streamline operations at PPLS and align our resources behind the national expansion of CyPath Lung," said Maria Zannes, bioAffinity President and Chief Executive Officer. "While these actions contributed to a decrease in consolidated revenue, we believe that the Company is now better positioned to leverage revenue generated from the profitable testing services performed in our lab. Importantly, revenue for our core value driver, CyPath Lung, increased 87% year over year, reflecting continued physician adoption and growing clinical utilization.

"The work we accomplished in 2025 was intentional and strategic. We strengthened our capital base, removed unprofitable legacy services from PPLS services and concentrated on high-value diagnostics. The launch of our longitudinal trial and our ongoing integration into the military healthcare system are both significant milestones that support our strategy of establishing CyPath Lung as a standard of care for indeterminate pulmonary nodules and a tool for surveillance after cancer treatment.

"Every day, we hear from practitioners who confirm the need for noninvasive, accurate lung cancer diagnostics, particularly when imaging and risk models are inconclusive or turn out to be wrong. CyPath Lung remains our first priority. It is a gamechanger that provides clinical confidence for physicians and better outcomes for patients. We believe our focus on improving care for patients at risk for lung cancer and other pulmonary diseases will create long-term value for our shareholders."

2026 Outlook

● Financial Outlook. bioAffinity entered 2026 with strong momentum, building on a year of increased sales and revenue growth and positioning the Company for continued expansion in the lung cancer diagnostics market. Our forecast for unit sales of CyPath Lung reflects an increase of greater than 100% over 2025, with a corresponding increase in revenues for our noninvasive lung cancer diagnostic. We will continue to expand our market both geographically and by the number of physicians and medical facilities adding CyPath Lung to the diagnostic pathway for patients with indeterminate pulmonary nodules and to post-treatment care for surveillance of lung cancer survivors.

● Market Opportunity. Consistent with estimates from the US Preventive Services Task Force, the number of indeterminate pulmonary nodules detected in the U.S. through lung cancer screening and incidental imaging is projected to grow 62% from 2.9 million in 2025 to 4.7 million in 2030, representing an estimated market opportunity exceeding $4.7 billion for CyPath Lung. The forecast assumes 10% compound annual growth from 2024–2030, driven by increased lung cancer screening adoption, improved adherence to screening guidelines, and enhanced detection through AI-enabled imaging tools. Another market opportunity opening up for CyPath Lung is its potential to improve post-treatment surveillance for lung cancer survivors. The number of Americans living with lung cancer is projected to increase 28% from 680,450 in 2025 to 871,580 in 20352, representing an estimated $870 million market opportunity over the next decade.

● CyPath Lung Longitudinal Trial. In March 2026, we enrolled the first patient in our longitudinal study evaluating CyPath Lung as a noninvasive diagnostic for high-risk patients with indeterminate pulmonary nodules. The trial plans to enroll up to 2,000 patients across 17 Veterans Administration (VA), military, academic, and private medical centers and will assess the sensitivity and specificity of the test over a follow-up period of up to two years. The John P. Murtha Cancer Center Research Program (MCCRP), a research program within the Department of Surgery at the Uniformed Services University of the Health Sciences in Bethesda, Maryland, is providing support and funding associated with the trial at several federal facilities. This study is intended to provide additional clinical validation to support broader adoption in federal and commercial markets.

● Military Research Collaboration to Expand Sample Collection Options for CyPath Lung. In February 2026, we announced a collaboration with Brooke Army Medical Center (BAMC) to evaluate the use of CyPath Lung on sputum samples obtained via tracheal and bronchial suctioning during bronchoscopy. This study is designed to assess the clinical utility of CyPath Lung for earlier detection of lung cancer in patients undergoing standard bronchoscopy procedures, potentially expanding the test’s applicability to a larger patient population and increasing integration into pulmonology workflows.

● Real-World Case Studies Validate CyPath Lung. The Company released 10 patient case studies in 2025 including multiple cases in which CyPath Lung detected curative Stage 1A lung cancer. In February 2026, we released two new real-world clinical cases in which a negative CyPath Lung test result supported the physician’s decision to continue monitoring high-risk patients with indeterminate nodules through noninvasive surveillance. CyPath Lung guided physician decision-making and reduced the burden on the patients by easing anxiety and helping them avoid additional invasive, costly and often risky procedures. The body of clinical evidence behind CyPath Lung and real-world case studies continues to grow.

● Positive Findings Presented at AAAAI on Expansion of Platform Technology to Asthma. In February 2026, the Company presented research on the ability of our innovative diagnostic platform to identify antibody drug receptors in sputum, including receptors for dupilumab, a leading therapy for asthma and chronic obstructive pulmonary disease (COPD), and benralizumab, another asthma therapy. The research supports advancement of the Company’s pipeline tests aimed at guiding personalized treatment decisions and improving disease monitoring for asthma and COPD sufferers.

2025 Financial Results

● Revenue was $6.2 million, compared with $9.4 million for 2024. The decrease reflects targeted strategic actions to discontinue certain unprofitable services and reallocate resources toward CyPath Lung. Testing revenue for CyPath Lung increased 87% year-over-year, driven by increased adoption by physicians and clinics, including the VA.

● Operating expenses decreased 9% to $16.7 million in 2025, primarily due to strategic actions aimed at streamlining and reducing lab operation costs.

● Research and development expenses were $1.4 million in 2025, slightly lower than the prior year, reflecting ongoing investment in lab operations and preclinical development.

● Selling, general and administrative expenses remained flat at $9.9 million.

● Net loss for the year ended December 31, 2025, was $14.9 million, compared to $9.0 million for 2024. The increase was primarily attributable to changes in the fair value of warrants, expanded sales activities and increased clinical development.

● Cash and cash equivalents as of December 31, 2025, were $6.5 million, compared with $1.1 million at the end of 2024. The Company raised $16.9 million in multiple financings in 2025 to support ongoing operations.

About CyPath Lung

CyPath Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters.

(Press release, BioAffinity Technologies, MAR 13, 2026, View Source [SID1234663537])

On March 13, 2026 AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision therapeutics for neurodegenerative diseases, reported results for the full year ended December 31, 2025, and provided a corporate update.

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Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: "We made significant progress towards delivering precision prevention of neurodegenerative diseases in 2025, exemplified by the exceptional interim data from the VacSYn trial of ACI-7104, our wholly-owned active immunotherapy targeting α-synuclein. Evidence that ACI-7104 appears to slow the rate of progression in early Parkinson’s disease (PD) further demonstrates the potential for active immunotherapies as disease-modifying treatments with the potential to slow or prevent neuronal damage."

"Our novel Morphomer small-molecule therapeutics complement these programs by targeting intracellular mechanisms, enabling intervention at the earliest stages of disease. ACI-19764, a brain-penetrant NLRP3 inhibitor with potential to treat numerous diseases both within and beyond neurodegeneration, is now in a Phase 1 trial."

Full Year 2025 and Subsequent Highlights:

ACI-7104 anti-α-synuclein active immunotherapy

● Reported positive interim safety and efficacy results from Part 1 of the Phase 2 VacSYn trial of our wholly-owned anti-α-synuclein active immunotherapy ACI-7104 in early PD.
● Results suggest, for the first time, that targeting underlying α-synuclein pathology with an active immunotherapy may slow the rate of progression of Parkinson’s disease.
● These results could translate into a shift from treating symptoms toward true disease modification in PD
● Clear safety profile with no clinically relevant safety issues reported to date
● Targets met for immunogenicity (100% responder rate), pharmacodynamic effect, target engagement and clinical assessments
● Final data from Part 1 of the study expected in mid-2026.

● Progressed the Morphomer small molecule Tau aggregation inhibitors for the potential treatment of Alzheimer’s disease (AD) and other neurodegenerative diseases.
● Investigational New Drug (IND)-enabling studies are expected to begin in H1 2026.
NLRP3 inhibitor, ACI-19764, small molecule program

● Dosed the first participants in a Phase 1 clinical trial of ACI-19764, a brain-penetrant small molecule targeting the NLRP3 inflammasome (NCT07463196).
● Our NLRP3 inhibitors have potential to intervene at the earliest stages of disease in neurodegenerative conditions, including AD, PD, amyotrophic lateral sclerosis (ALS) and frontotemporal dementia.
● Potential additional indications include inflammatory disorders (e.g., multiple sclerosis, inflammatory bowel disease, gout), cancer, cardiovascular disease, metabolic disorders (e.g., Type 2 diabetes, obesity), skin inflammatory diseases (e.g. hidradenitis suppurativa) and rare genetic syndromes of autoimmunity such as Cryopyrin-associated periodic syndromes (CAPS).
● ACI-19764, an orally available, brain-penetrant NLRP3 inhibitor is a major addition to AC Immune’s growing intracellular targeting pipeline.
Sharpened Pipeline Focus with Operational Efficiencies Extending Cash Runway

● Following a strategic review by executive management, sharpened investment on our most important assets.
● These include the three clinical-stage active immunotherapy programs ACI-7104, ACI-24 and ACI-35, the latter two of which are in ongoing pharma collaborations, and promising small molecule programs targeting NLRP3, Tau and α-synuclein.
● The Company reduced its workforce by around 30% and extended its cash for operations to the end of Q3 2027.
AC Immune research results published in peer-reviewed journals and presented at conferences:

● Clinical results from the completed Phase 1b/2a trial of active immunotherapy ACI-35 (JNJ-2056) partnered with Janssen Pharmaceuticals, Inc., a Johnson & Johnson company, in eBioMedicine.
●Preclinical research demonstrating the in vivo activity of a vectorized (AAV9) anti-TDP-43 monoclonal antibody in a model of ALS/FTD, in Molecular Therapy.
●First-in-class positron emission tomography (PET) tracers for imaging TDP-43 pathology in the brain, including ACI-19626, that could enable a precision medicine approach to neurodegenerative diseases which are currently difficult to diagnose, in Nature Communications.
●Featured the company’s therapeutic and diagnostic programs in presentations at AD/PD 2025 where we also hosted an industry symposium highlighting the company’s leading pipeline of active immunotherapies for precision prevention of neurodegenerative diseases.

Anticipated 2026 Milestones

Program

Milestone

Expected in

ACI-7104
anti-α-synuclein active immunotherapy

Final data from Part 1 of the Phase 2 VacSYn trial in PD expected in mid-2026

H2 2026

ACI-24
anti-Abeta active immunotherapy

Interim results from ABATE Phase 2 trial after reaching 12-month treatment timepoint in the AD3 cohort

H1 2026

ACI-19764
NLRP3 inhibitor

Results from Phase 1 trial in healthy volunteers

H2 2026

Morphomer-Tau aggregation inhibitors

Lead declaration and initiation of IND-enabling studies

H1 2026

Morphomer α-synuclein aggregation inhibitor

Lead declaration

H1 2026

Analysis of Financial Statements for the Full Year Ended December 31, 2025

● Cash Position: The Company had total cash resources of CHF 91.4 million as of December 31, 2025, compared to total cash resources of CHF 165.5 million as of December 31, 2024. The Company’s cash balance provides sufficient capital resources into Q3 2027, assuming no other milestones.
● Contract Revenues: The Company recorded CHF 3.6 million in contract revenues for the year ended December 31, 2025, compared with CHF 27.3 million in the prior year. For the year ended December 31, 2025, our contract revenues of CHF 3.6 million were related to the efforts made under the agreement with Takeda for development, CMC, and regulatory activities. The decrease compared to the prior year relates to the recognition of the second ReTain-related milestone payment of CHF 24.6 million under the agreement with Janssen in 2024.
● R&D Expenditures: R&D expense decreased by CHF 6.1 million for the year ended December 31, 2025 to CHF 56.4 million, predominantly due to:
o Discovery and preclinical expenses: Decrease of CHF 1.6 million, primarily due to the completion of certain pre-clinical studies and our strategic focus on advancing clinical-stage programs.
o Clinical expenses: Decrease of CHF 4.4 million, primarily due to lower costs related to manufacturing activities for our Phase 2 VacSYn study evaluating ACI-7104 in early PD and certain non-recurring manufacturing costs in 2024. These changes were offset by increased costs associated with our NLRP3 inhibitor program, which entered clinical development in 2026, and higher costs associated with our PET Tracer programs.
o Salary- and benefit-related costs: Decrease of CHF 0.7 million, primarily due to decreased share-based compensation in the current year.
● G&A Expenditures: G&A expenses decreased by CHF 1.1 million for the year ended December 31, 2025, to CHF 16.1 million. This decrease is primarily due to legal fees in 2024 which did not recur.
● Restructuring Expenditures: Expenses recognized as a result of the restructuring were CHF 0.5 million compared to nil for the year ended 2024. These expenses include CHF 2.1 million of termination benefits, offset by a CHF 1.8
million gain on curtailment in the defined benefit pension liability. The remaining balance pertains to other non-cash activities within share-based compensation.
● Financial Result: Net finance result was a CHF 1.1 million loss for the year ended December 31, 2025, compared with a CHF 1.5 million gain in 2024. This was due to lower interest received on net investments in short-term financial assets and foreign exchange differences caused by foreign currencies depreciating against CHF, predominantly the U.S. Dollar.
● IFRS Loss for the Period: The Company reported a net loss after taxes of CHF 70.5 million for the year ended December 31, 2025, compared with a net loss of CHF 50.9 million for the prior year.
2026 Financial Guidance

● For the full year 2026, the Company expects its total cash expenditure to be in the range of CHF 55-65 million. The Company defines total cash expenditure as operating expenditure adjusted to include capital expenditure and offset by significant non-cash items (including share-based compensation and depreciation expenses).

(Press release, AC Immune, MAR 13, 2026, View Source [SID1234663536])

On March 13, 2026 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), reported that the Independent Data Monitoring Committee (IDMC) for the TACTI-004 Phase III study evaluating eftilagimod alfa ("efti") in patients in 1st line non-small cell lung cancer has recommended the discontinuation of the trial following a planned interim futility analysis in accordance with the study protocol.

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Based on its review of the available safety and efficacy data, the IDMC recommended that the trial be discontinued for futility.

In response to the IDMC’s recommendation, enrolment in the study will be halted and the Company will implement an orderly wind down of the study, including appropriate patient follow up and site close out in accordance with regulatory and ethical obligations.

"We are very disappointed and surprised with the outcome of the futility analysis, in light of efti’s performance in every other clinical trial" said Marc Voigt, Chief Executive Officer. "We would like to thank the patients, investigators, and clinical teams who contributed to this important study. We are currently conducting a comprehensive review of the available data to better understand the results and determine the appropriate next steps for the program."

Immutep remains focused on advancing its pipeline of innovative therapies including efti. Following the discontinuation of TACTI-004, Immutep now anticipates its cash runway will be extended well beyond the previously guided timeframe of Q2 CY2027, which was set prior to the trial’s cessation. The Company will provide an updated outlook on its revised cash runway and will reassess capital allocation priorities once operational assessments and a full analysis of the study data have been finalised.

About TACTI-004
TACTI-004 (Two ACTive Immunotherapies) is a randomised, double-blind, controlled Phase III study evaluating eftilagimod alfa (efti), a first-in-class MHC Class II agonist, in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab), and chemotherapy as first line therapy for patients with advanced or metastatic non-small cell lung cancer with no EGFR, ALK or ROS1 genomic tumour aberrations. The global trial was to enrol approximately 756 patients regardless of PD-L1 expression and with non-squamous or squamous tumours at over 150 clinical sites in over 25 countries. Patients were being randomised 1:1 to receive either efti in combination with pembrolizumab and chemotherapy in the treatment arm or pembrolizumab in combination with chemotherapy and placebo in the control arm. The study’s dual primary endpoints were progression-free survival and overall survival.

About Eftilagimod Alfa (Efti)
Efti is a novel immunotherapy that directly activates antigen-presenting cells or APCs (e.g. dendritic cells, monocytes) via the MHC Class II pathway to fight cancer. As an MHC Class II agonist, its activation of APCs engages the adaptive and innate immune system to initiate a broad anti-cancer immune response. This includes priming and activating cytotoxic T cells as well as generating important co-stimulatory signals & cytokines that further boost the immune system’s ability to combat cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), as well as head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile has enabled various combinations like with anti-PD-[L]1 immunotherapy, radiotherapy, and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).

(Press release, Immutep, MAR 13, 2026, View Source [SID1234663513])

On March 12, 2026 20/20 BioLabs (Nasdaq: AIDX), an early market entrant in cutting-edge, AI powered laboratory-based blood tests for the early detection and prevention of cancers and chronic diseases, reported an update on its patented protein tumor marker (PTM) based, machine learning (ML) derived multi-cancer early detection (MCED) methodology in the wake of several recent studies suggesting the expected value of this approach for earlier stage detection compared to stand-alone circulating tumor DNA (ctDNA) based MCEDs.

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As population-scale cancer screening studies continue to generate trial data and real-world evidence, the medical community, consumers, investment community, and scientific experts are increasingly focused on which MCEDs and biomarker modalities are best suited to detect cancers early enough to meaningfully change patient outcomes. Results reported in February 2026 from a large-scale ctDNA-based MCED study conducted in the U.K. has prompted broader discussion about the biological limitations of circulating tumor DNA as first-line screening tests for early-stage disease.

Generally, for MCED tests to be clinically meaningful, they must detect cancer early enough to change outcomes. Among other things, this requires biomarkers that are present and detectable before tumors shed sufficient DNA into the bloodstream. Circulating tumor DNA (ctDNA)-based tests, while valuable in detecting advanced disease, face a fundamental biological constraint: in early-stage cancers, where tumor burden is low, DNA shedding is often intermittent or absent. As a result, ctDNA signals may only become reliably detectable after disease has progressed beyond the window of greatest clinical impact.

"The U.K. trial confirms that MCED blood testing can meaningfully shift the stage of cancer diagnosis. However, it also underscores that detecting the earliest cancers remains a fundamental biological challenge for ctDNA-based tests, as cancer biology does not begin with DNA fragment release in the bloodstream," said Michael Lebowitz, Ph.D., Chief Scientific Officer of 20/20 BioLabs. "A scalable future for population screening will likely combine technologies, with sensitive protein biomarkers identifying risk earlier and genomic assays providing confirmatory precision."

Studies published by 20/20 Biolabs and several independent research groups in the U.S. and Asia over the past 10 months add to the growing body of evidence that our company’s patented multi-cancer testing approach may help overcome many of the limitations of ctDNA for earlier stage detection:

In May 2025 20/20 Biolabs presented data on the sensitivity of its OneTest for Cancer (Premium version) at the annual meeting of the U.S. National Cancer Institute’s (NCI) Early Detection Research Network (EDRN), demonstrating detection rates for early-stage cancers as high as 50% for some tumor types — including pancreatic and ovarian cancers — from a pre-diagnostic (asymptomatic) population using a blinded cohort supplied by the NCI. (EDRN Poster May 2025)
Additional support for using protein tumor markers comes from a large, multicenter validation study published in Nature’s Precision Oncology in October 2025, which evaluated an AI enhanced blood test integrating seven well established protein tumor markers (6 of which are part of OneTest) across more than 15,000 participants from seven centers in three countries (USA, China, and Brazil). The study demonstrated consistent cancer signal detection across diverse populations, with measurable sensitivity even in Stage I disease and progressively higher detection rates as cancers advanced.
In a blinded validation study published in November 2025, investigators at MD Anderson Cancer Center reported that a protein based multicancer test—with most of the same biomarkers measured in OneTest (Standard version)—identified nearly 90% of early stage lung cancers and flagged multiple other cancers a median of 12–21 months prior to diagnosis, supporting the sensitivity of protein tumor markers during early oncogenesis.

These recent reports build upon hundreds of studies over several decades showing the sensitivity of PTMs for early-stage detection of many different tumor types, especially following repeat (serial) testing. This evolving evidence reinforces the scientific and commercial rationale for large scale screening first with its protein biomarker-based OneTest for Cancer test prior to considering the more costly ctDNA tests or advanced imaging platforms.

"Given the higher sensitivity of protein-based tests for Stage I and II cancers, a tiered approach in which protein-based tests like OneTest serve as the initial screening step makes sense," suggests Dr. Lebowitz. "Individuals identified by protein-based tests to be at mild risk can then be directed into ctDNA-based testing within a 3–6-month window, when ctDNA signals are more likely to be present. We believe those deemed at higher risk by protein–based tests are likely better served by moving directly to imaging studies. This tiered, or multi-step, approach is likely to yield the best outcomes and the lowest costs."

Results from the ctDNA MCED trails in the U.K. come shortly after Congress passed legislation in February 2026 to create a pathway for Medicare coverage of MCEDs beginning in 2028.

"The reimbursement opportunity created by the new legislation is an important step forward for cancer screening access," said Jonathan Cohen, CEO of 20/20 BioLabs. "As coverage decisions are made, we believe the science supports a broader view of MCED — one that includes protein-based technologies that have demonstrated meaningful early-stage detection. We are committed to continuing to build the evidence base and to working with policymakers, regulators, and payers to ensure that the most meaningful and cost-effective screening tools are readily available to Americans."

(Press release, 20/20 GeneSystems, MAR 12, 2026, View Source [SID1234663528])

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])