On March 10, 2026 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on non-invasive diagnostics and early cancer detection, reported initiation of the Company’s planned large-scale, longitudinal clinical study for CyPath Lung, its noninvasive diagnostic test for the detection of early-stage lung cancer.

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The 2,000-patient longitudinal study is designed to evaluate the clinical performance of the CyPath Lung flow cytometry test as a noninvasive diagnostic that uses sputum samples to detect the presence of lung cancer in high-risk individuals with existing lung nodules six millimeters (mm) to less than 30 mm in diameter identified by lung cancer screening. In an earlier clinical trial, CyPath Lung showed 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients with small pulmonary nodules less than 20mm. Several recent patient case studies demonstrate the test’s ability to detect lung cancer at its curative Stage 1A.

bioAffinity Technologies expects up to 20 clinical study sites, including a dozen Department of Veterans Affairs (VA) medical centers and two of the nation’s largest military hospitals, will participate in the study. Michael J. Morris, MD, pulmonology and critical care physician at Brooke Army Medical Center, is the national Principal Investigator for the study (NCT07168993). 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.

Physicians currently order CyPath Lung, a laboratory developed test (LDT) offered by bioAffinity Technologies’ subsidiary Precision Pathology Laboratory Services, for their patients with indeterminate lung nodules to determine next steps in patient care.

The longitudinal clinical trial announced today will evaluate FlowPath Lung, a research-use test that uses the same technology and follows the same procedures as CyPath Lung. The different name is simply used to distinguish the investigational assay from the commercially available test.

"As more indeterminate pulmonary nodules are found either incidentally or by routine lung cancer screening, CyPath Lung can fill the diagnostic gap between ‘watchful waiting’ and invasive procedures that carry risk," said Gordon Downie, MD, PhD, Chief Medical Officer of bioAffinity Technologies. "As a result, we see growing adoption and use of CyPath Lung by physicians and expect this longitudinal trial to provide additional evidence to support inclusion of our noninvasive test as part of the standard of care for lung cancer screening and diagnosis."

"Initiating this study represents an important milestone for CyPath Lung," said Maria Zannes, President and CEO of bioAffinity Technologies. "By following patients longitudinally across multiple sites, we expect to acquire robust, real-world data that reflects how CyPath Lung may be used to support risk assessment and clinical decision-making aligned with our objective to establish CyPath Lung as a standard of care for evaluating patients at high-risk for early-stage lung cancer."

The study includes participation from several federal facilities to examine the test’s performance in diverse patient populations, including military service members and veterans. Patient enrollment is expected to take up to 18 months with patients followed for up to 24 months or until a definitive diagnosis of cancer or no cancer is determined.

About CyPath Lung

CyPath Lung is a non-invasive 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 10, 2026, View Source [SID1234663409])

On March 10, 2026 Jacobio Pharma(HKEX: 1167) reported its annual results for the year ended Dec. 31, 2025, and provided updates on its key pipeline programs.

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During 2025, the company achieved several key advancements in KRAS-targeted therapy and innovative ADC platforms, including the approval and inclusion of the KRAS G12C inhibitor glecirasib in China into the National Reimbursement Drug List, a collaboration agreement with AstraZeneca for the pan-KRAS inhibitor JAB-23E73 worth a total of US$2.015 billion (including an upfront payment of US$100 million), and the entry of EGFR-KRAS G12Di tADC and HER2-STINGa iADC into the IND preparation stage.

Dr. Yinxiang Wang, Chairman and Co-Chief Executive Officer of Jacobio, said:
"2025 marked the tenth anniversary of Jacobio and a milestone year of value for the Company. The approval of glecirasib and its reimbursement inclusion in China marked Jacobio’s entry into commercialization. At the same time, JAB-23E73 achieved steady progress over the past year, including completion of the Phase I dose escalation phase of daily dosing in China, generation of preliminary promising clinical data, and the IND approval of its first-line pancreatic cancer combination study. Looking ahead, we will continue to focus on KRAS-targeted therapies and innovative functional-payload ADC platforms, including tADC and iADC, with the goal of bringing more treatment options to patients worldwide."

Pipeline Highlights

Glecirasib (KRAS G12C inhibitor)

In 2025, glecirasib was approved in China for the treatment of patients with KRAS G12C-mutated non-small cell lung cancer who had received at least one prior systemic therapy, and was subsequently included in the National Reimbursement Drug List. From June to December 2025, Jacobio recognized revenue of RMB 8.55 million.

A registrational Phase III trial evaluating glecirasib in combination with the SHP2 inhibitor sitneprotafib for the first-line treatment of non-small cell lung cancer is ongoing in China. Results from the Phase I/II study of this combination were published in The Lancet Respiratory Medicine, demonstrating a 71% objective response rate and a median progression-free survival of 12.2 months in the first-line setting.

Over the past year, multiple clinical studies of glecirasib were published in leading international journals, including Nature Medicine, The Lancet Respiratory Medicine, The Lancet Gastroenterology & Hepatology, and Cancer Communication.

pan-KRAS inhibitor JAB-23E73

JAB-23E73 is an oral small-molecule pan-KRAS inhibitor currently undergoing clinical development in China and the United States.

As of Jan. 15, 2026, a total of 42 patients had been enrolled in the Phase I study in China. Grade 3 treatment-related adverse events were reported in 11.9% of patients, and no Grade 4 or Grade 5 treatment-related adverse events were observed. Among 13 pancreatic cancer patients treated within the predicted efficacious dose range — including two second-line and eleven third-line or later patients — the objective response rate (ORR), including both confirmed and unconfirmed responses, was 38.5%, and the disease control rate (DCR) was 84.6%.

In February 2026, China’s Center for Drug Evaluation approved a Phase I/III clinical trial evaluating JAB-23E73 in combination with nab-paclitaxel and gemcitabine as a first-line treatment for KRAS-mutant pancreatic ductal adenocarcinoma.

ADC Programs

Jacobio continues to advance its xADC platform built around functional payloads.

JAB-BX600 (EGFR-KRAS G12D tADC) combines an EGFR-targeting antibody with a KRAS G12D inhibitor payload, enabling targeted delivery and a dual-mechanism approach that may overcome feedback resistance associated with KRAS inhibitor monotherapy. An IND submission is expected in the second half of 2026.

JAB-BX467 (HER2-STING iADC) uses a HER2-targeting antibody linked to a STING agonist payload designed to recruit lymphocytes in the tumor microenvironment and potentially convert "cold" tumors into "hot" tumors. An IND submission is expected in the second half of 2026.

Financial Update

As of the end of 2025, the Company had approximately RMB1.53 billion in cash, cash equivalents and available bank credit facilities. This balance is expected to exceed RMB2.0 billion in the first quarter of 2026, and the Company anticipates achieving profitability in 2026.

(Press release, Jacobio Pharmaceuticals, MAR 10, 2026, View Source [SID1234663426])

On March 10, 2026 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported plans for an independent company to be established and led by BioNTech co-founders Prof. Ugur Sahin, M.D., and Prof. Özlem Türeci, M.D. The new company with distinct resources, operations and funding options, will advance next-generation mRNA innovations. BioNTech plans to contribute related rights and mRNA technologies to the new company to enable and support the prioritized development of next-generation mRNA innovations with disruptive potential. With both companies focusing on their respective strategic priorities, BioNTech expects to maximize value for patients and shareholders alike.

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BioNTech is sharpening its strategic focus on the development and commercialization of its growing late-stage pipeline spanning innovative immunomodulator, antibody-drug conjugate ("ADC") and mRNA candidates. Its current clinical pipeline, including previously announced milestones and the COVID-19 vaccine franchise, remains unaffected by the plans for the new company: BioNTech expects to have 15 ongoing Phase 3 clinical trials in oncology by year end. 2026 will also be the first year in which the Company expects multiple late-stage data readouts across major cancer types. The clinical trials and resulting data will inform regulatory and launch plans.

Ugur Sahin and Özlem Türeci will transition into the management of their new company by the end of 2026 after their current service agreements end. BioNTech’s Supervisory Board has initiated an executive search to identify successors for the positions to ensure a smooth transition and seamless execution of BioNTech’s strategy.

"Over the past 18 years, we have built BioNTech from a start-up into a global biopharmaceutical company with a strong and diversified pipeline. During the COVID-19 pandemic, we expanded beyond oncology to develop the first approved mRNA vaccine, helping to protect people worldwide. Today, the company is well positioned to advance its mission and evolve into a commercial multi-product company. None of this would have been possible without the extraordinary dedication of our teams, the trust of our shareholders and Supervisory Board, and the commitment of the partners who have supported us along the way. For us, this is the right time to prepare to hand over the baton," said Prof. Ugur Sahin, M.D., Chief Executive Officer and Co-Founder of BioNTech. "At the same time, Özlem and I are ready to become pioneers once again. Our vision has always been to translate our science into meaningful advances for patients, and we see extraordinary opportunities to unlock the next generation of transformative innovations."

"Over the course of their careers, Ugur and Özlem have established an outstanding track record of innovation. As BioNTech advances multiple late-stage product candidates towards commercialization, we support them in taking the opportunity to apply their strengths and undivided attention to a new venture, dedicated to enabling mRNA-based technologies to reach their full potential," said Helmut Jeggle, Chairman of the BioNTech Supervisory Board. "We believe that this plan will be additive for both, BioNTech and the new company, as it aims to allow each organization to drive meaningful impact for patients. We look forward to working together with their new company on potential combination therapy approaches, setting the stage for continued success."

BioNTech co-founders and mRNA technology pioneers Prof. Ugur Sahin, M.D., and Prof. Özlem Türeci, M.D., will establish their third biotechnology company following the foundation of Ganymed Pharmaceuticals in 2001 and BioNTech in 2008. As a next-generation mRNA company, it is aimed at pioneering cutting-edge platform technologies and advancing the research and development of mRNA-based innovations with disruptive potential. To this end, BioNTech plans to contribute related rights and mRNA technologies to the new company on an arm’s length basis in exchange for a minority stake and other forms of consideration such as milestones and royalties. It aims to benefit both companies by providing them with opportunities to collaborate on combination approaches involving their respective product candidates, with the potential to create new complementary or synergistic treatment strategies. A binding agreement is expected to be signed by the end of the first half of 2026 after which further details will be communicated by BioNTech.

(Press release, BioNTech, MAR 10, 2026, View Source [SID1234663410])

On March 10, 2026 C-Further, an international consortium committed to creating new therapeutics for childhood cancers, reported the first early-stage therapeutic programmes for its pipeline, dedicated to paediatric oncology indications. Through its collaborative model, C-Further has partnered with investigators at UVA Comprehensive Cancer Center, Dana-Farber Cancer Institute and Mass General Brigham to advance CF-012 for the potential treatment of Ewing sarcoma. In parallel, the consortium has partnered with investigators at MiNK Therapeutics (Nasdaq: INKT) to advance CF-033, leveraging MiNK’s proprietary platform with translational support by investigators at the University of Southampton, for the potential treatment of multiple children’s cancers, including bone sarcoma, medulloblastoma and acute myeloid leukaemia.

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Enabled by C-Further’s core partners, Cancer Research Horizons, LifeArc and Great Ormond Street Hospital Charity (GOSH Charity), the consortium will support the progression of CF-012 and CF-033 up to preclinical candidate nomination, subject to completion of scientific milestones. Together, these projects form the foundation of C-Further’s expanding pipeline which is supported by an initial $40m (£30m) budget.

Lone Friis, PhD, C-Further Programme Co-lead said: "By combining the pioneering approaches of our scientific collaborators with industry-standard drug discovery capabilities, expertise of our core partners and reach into critical paediatric-focused networks, C-Further is advancing a pipeline of potential first-in-class therapies for childhood cancers. Guided by an indication-agnostic but child-first approach, we believe the initial CF-012 and CF-033 programmes have the potential to address a profound unmet need across multiple children’s cancers."

The selected research partners represent top academic and industry investigators from across the globe, underscoring the international reach and ambition of C-Further.

CF-012 targets ETV6, a newly identified and critical transcriptional dependency that is essential for tumour growth and metastasis. The aim is to develop a potential first-in-class inhibitor with a precise mechanism to disrupt tumour growth and metastasis in young patients.

John Bushweller, PhD, Professor at the University of Virginia School of Medicine and a member of UVA Comprehensive Cancer Center, investigator for CF-012, said: "We’re excited to partner with C-Further to progress CF-012. Children and young people have historically lacked effective, targeted cancer treatments and CF-012 has the potential to address an urgent unmet need in relapsed and metastatic Ewing sarcoma – a rare, aggressive bone tumour that most commonly occurs in young people. With C-Further’s collaborative, child-first drug discovery model, we believe we have the power to bring these medicines to market."

Other key investigators for the CF-012 therapeutic programme include Kimberly Stegmaier, MD, Chair of the Department of Pediatric Oncology at Dana-Farber Cancer Institute, and Miguel Rivera, MD, Assistant Molecular Pathologist at Massachusetts General Hospital.
CF-033 is a potential first-in-class allogeneic iNKT cell therapy engineered with a specific T-cell receptor targeting PRAME, which bridges innate and adaptive immunity and is designed to enable both direct tumour cell killing and broader immune activation within the tumour microenvironment. As an allogeneic, off-the-shelf approach without the need for toxic lymphodepletion, CF-033 has the potential to support more timely treatment delivery and improved tolerability, which are important considerations in paediatric oncology, where new therapeutic approaches are urgently needed.

Marco Purbhoo, PhD, Head of Translational Medicine at MiNK Therapeutics, investigator for CF-033, said: "CF-033 is a PRAME-targeted invariant NKT (iNKT) cell therapy developed to address the urgent needs of children with high-risk cancers, which are often marked by treatment resistance and a weakened immune response that cannot sustain tumour control. Unlike conventional CAR-T or TCR-T therapies, CF-033 harnesses the unique biology of iNKT cells — immune cells that can both directly kill cancer and help coordinate a broader, longer-lasting anti-tumour response. Importantly, this approach is designed to be delivered without the need for HLA matching or toxic lymphodepletion, which is particularly meaningful for this vulnerable paediatric population."

Ali Roghanian, PhD, Associate Professor at the University of Southampton, is the other key investigator leading the CF-033 therapeutic programme.
C‑Further welcomes expressions of interest from researchers, innovators and partners who share its mission to accelerate new tailored and well-tolerated treatments for children and young people with cancer. The deadline to be considered for the next round of submissions is 13 March 2026.

C-Further has also commenced preliminary research on a third, undisclosed project. Additional programmes are expected to be announced in 2026.

(Press release, C-Further, MAR 10, 2026, View Source [SID1234663427])

On March 10, 2026 Artiva Biotherapeutics, Inc. (Nasdaq: ARTV) (Artiva), a clinical-stage biotechnology company whose mission is to develop effective, safe and accessible cell therapies for patients with devastating autoimmune diseases and cancers, reported financial results for the full year ended December 31, 2025, and highlighted recent progress.

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"2025 was a year of strong execution as we advanced our AlloNK program, successfully enrolling patients in community settings across autoimmune indications and prioritizing refractory RA as our lead indication," said Fred Aslan, M.D., president and chief executive officer of Artiva Biotherapeutics. "AlloNK has the potential to redefine the treatment paradigm for refractory RA by combining the durable efficacy of deep B-cell depletion with an outpatient-ready profile suitable for community rheumatology practices."

Dr. Aslan continued, "In 2026, our focus is to advance AlloNK from an early clinical program in the deep B-cell depletion space to what could become the first therapy in this class to initiate a registrational trial in RA, the autoimmune disease with the largest refractory population. We look forward to sharing initial clinical response data and engaging with the FDA on a potential pivotal trial design in refractory RA in the first half of 2026."

Recent Business Highlights

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Prioritized refractory RA as lead indication: Received FDA Fast Track designation for AlloNK in refractory RA and prioritized RA as the program’s lead autoimmune indication.
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Despite multiple approved biologic and targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs), there are more than 150,000 RA patients in the U.S. who have failed at least two prior therapies. Real-world data suggest ACR50 response rates at six months are typically in the 10 – 20% range, underscoring the significant unmet need and opportunity for AlloNK plus rituximab to drive deeper and more durable responses with a single treatment cycle.
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Artiva has successfully enrolled refractory RA patients across dose levels and will provide initial clinical response data from at least 15 patients, most of whom are expected to have six or more months of follow-up, in the first half of 2026.
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Demonstrated deep and consistent B-cell depletion supporting intended mechanism of action: Across patients analyzed, AlloNK plus rituximab resulted in non-quantifiable peripheral CD19+ B-cell levels by Day 13. These findings were confirmed using a high-sensitivity assay with 10- to 50-fold greater sensitivity than standard assays. Early reconstitution data demonstrated predominantly naïve and transitional B cells, consistent with immune reconstitution patterns observed with CD19-directed autologous CAR-T therapies.
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Established favorable safety and outpatient feasibility profile in autoimmune disease, leading to strong enrollment: As of the Oct. 1, 2025 data cutoff, 32 patients were treated with AlloNK plus rituximab across refractory RA, Sjögren’s disease, systemic lupus erythematosus (SLE), lupus nephritis and systemic sclerosis, entirely in the outpatient setting, with the majority treated in community rheumatology clinics. The regimen was well tolerated, with no reported cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), graft-versus-host disease or hypogammaglobulinemia.
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Reported continued durability in Phase 1/2 oncology trial: Presented longer-term data from the completed Phase 1/2 trial of AlloNK plus rituximab in relapsed/refractory B-cell non-Hodgkin lymphoma demonstrating a 64% complete response rate and a median duration of response not yet reached, exceeding 19.4 months at data cutoff, in line with commercially approved auto-CAR-T results in a comparable patient population.

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Enhanced executive leadership to support late-stage development and capital strategy: Appointed Subhashis Banerjee, M.D. as chief medical officer and Thad Huston as chief financial officer, adding deep rheumatology development expertise, regulatory experience and global financial leadership as AlloNK advances toward potential registrational development.
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Strengthened board leadership with deep immunology and commercial expertise: Appointed Dan Baker, M.D. and Elaine Sorg to the board of directors, adding extensive experience in autoimmune drug development, regulatory strategy and large-scale immunology commercialization, including leadership roles supporting major therapies for rheumatoid arthritis and other immune-mediated diseases in multibillion dollar franchises.
Upcoming Milestones

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Initial clinical response data in refractory RA expected in the first half of 2026: Artiva expects to report initial clinical response data in at least 15 patients, most of whom are expected to have six or more months of follow-up.
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Planned FDA interaction in the first half of 2026 to discuss potential pivotal trial design in refractory RA: Subject to feedback and alignment with the FDA, AlloNK has the potential to become the first deep B-cell depleting therapy to initiate a pivotal trial in patients with refractory RA.
Full Year 2025 Financial Results

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Cash, Cash Equivalents and Investments. As of December 31, 2025, Artiva had cash, cash equivalents, and investments of $108.0 million, which is expected to fund operations into Q2 2027.
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License and Development Support Revenue. License and development support revenue was zero for the year ended December 31, 2025, compared to $0.3 million for the year ended December 31, 2024.
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Research and Development Expenses. Research and development expenses were $69.5 million for the year ended December 31, 2025, compared to $50.3 million for the year ended December 31, 2024.
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General and Administrative Expenses. General and administrative expenses were $20.3 million for the year ended December 31, 2025, compared to $17.2 million for the year ended December 31, 2024.
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Other Income, net. Other income, net, was $5.9 million for the year ended December 31, 2025, compared to other income, net, of $1.9 million for the year ended December 31, 2024.
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Net Loss. Net loss totaled $83.9 million for the year ended December 31, 2025, as compared to net loss of $65.4 million for the year ended December 31, 2024, with non-cash stock-based compensation expense of $6.8 million and $7.0 million for the years ended December 31, 2025 and 2024, respectively.

(Press release, Artiva Biotherapeutics, MAR 10, 2026, View Source [SID1234663452])