On August 10, 2026 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, reported financial results and business highlights for the second quarter 2026.

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"Our team is executing on our goals of beginning clinical studies soon for both SC451 in type 1 diabetes and SG293 in non-Hodgkin lymphoma," said Steve Harr, President and Chief Executive Officer. "Proof of concept data for these programs, including the recent update for UP421 in The New England Journal of Medicine and for an SG293 surrogate at the ASGCT (Free ASGCT Whitepaper) meeting, are encouraging. If all goes as we anticipate, we expect to gain valuable insight into the clinical profiles and potential of both SC451 and SG293 over the next 6-9 months, and we look forward to sharing our progress."

Corporate Highlights

Continued progress toward beginning clinical trials for SC451 and SG293

SC451, an O-negative, hypoimmune (HIP)-modified, iPSC-derived pancreatic islet cell therapy which uses the same HIP technology as UP421, is being developed as a one-time treatment for patients with type 1 diabetes with a goal of long-term normal blood glucose without the need for any insulin therapy or immunosuppression. Sana is conducting activities to prepare for SC451 investigational new drug application (IND) submission and Phase 1/2 trial start, including near-term completion of GLP toxicology studies, advancement of SC451 technology transfer to the contract manufacturer, and clinical trial readiness. Sana expects to file an IND and begin a Phase 1/2 clinical trial for SC451 as early as this year.
SG293 is a CD8-targeted fusosome that delivers the genetic material to make CD19-directed CAR T cells. SG293 has been designed to minimize potential toxicities related to in vivo CAR T cells, including peri-infusion reactions and off-target delivery to tissues such as the liver. Preclinical data presented at the ASGCT (Free ASGCT Whitepaper) 2026 Annual Meeting demonstrate that a SG293 surrogate, which is active in non-human primates, achieves cell-specific delivery and deep B cell depletion – as measured by depletion in circulating and lymph node B cells as well as a phenotypic reset when B cells return – in non-human primates without the use of any lymphodepleting chemotherapy. Sana expects to generate first-in-human data for SG293 in non-Hodgkin lymphoma as early as this year. If successful, the company intends to expand clinical development into B cell-mediated autoimmune diseases as well.

Shared updated, positive results from an investigator-sponsored, first-in-human study transplanting UP421, an allogeneic primary islet cell therapy engineered with HIP technology, into a patient with type 1 diabetes without the use of any immunosuppression.

UP421 is a primary human HIP-modified pancreatic islet cell therapy for patients with type 1 diabetes. The goal of this investigator-sponsored trial (IST) is to understand safety, immune evasion, islet cell survival, and beta cell function, as measured by C-peptide production, of HIP-modified pancreatic islet cells transplanted into a type 1 diabetes patient without the use of any immunosuppression. The trial is being conducted under a clinical trial authorization at Uppsala University Hospital with Dr. Per-Ola Carlsson as the principal investigator.
Results of the study through 14 months after cell transplantation demonstrated the survival and function of pancreatic beta cells in a patient as measured by the presence of circulating C-peptide, a biomarker indicating that transplanted beta cells are producing insulin. C-peptide levels also increased with mixed meal tolerance tests (MMTT) performed over the course of the study, consistent with insulin secretion in response to a meal. Fasting and MMTT-stimulated C-peptide levels at month 14 were comparable to those observed in the first six months of the study. PET-MRI scanning performed at week 12 and again at week 52 demonstrated islet cells at the transplant site in the forearm. The study has identified no safety issues, and the HIP-modified islet cells have evaded immune detection.
Announced that The New England Journal of Medicine published a peer-reviewed Letter to the Editor titled "Long-Term Survival of Hypoimmune Allogeneic Islets without Immunosuppression" (DOI: 10.1056/NEJMc2604408), which discusses 14-month results from this study.
14-month data from the study were presented at the International Society for Stem Cell Research (ISSCR) 2026 Annual Meeting in July 2026, and additional data from the IST will be presented at the European Association for the Study of Diabetes (EASD) Annual Meeting 2026 on October 2.

Announced strategic collaboration with Mayo Clinic to advance development of SC451, a HIP-modified, induced pluripotent stem cell (iPSC)-derived pancreatic islet cell therapy for type 1 diabetes.

The purpose of the collaboration is to draw on Mayo Clinic’s multidisciplinary expertise to accelerate the development, validation, and standardization of protocols and processes for SC451, supporting safe, scalable, and consistent delivery across diverse clinical environments.
In connection with the collaboration, Mayo Clinic made a $25.0 million equity investment in the company, reflecting a shared commitment to advancing innovative approaches aimed at improving care for patients with type 1 diabetes.

Advanced preclinical pipeline

SG227, a CD8-targeted fusosome that delivers the genetic material to make BCMA-directed CAR T cells, is being developed as a potential treatment for patients with multiple myeloma. SG227 delivers a BCMA CAR that has been validated in the autologous CAR T setting for patients with multiple myeloma in a product that is currently approved in China. Sana is preparing to begin clinical testing as early as mid-2027, contingent upon the early clinical profile of SG293.

Raised aggregate net proceeds of $93.3 million from sales of common stock through Sana’s at-the-market offering facility (ATM) and Mayo Clinic investment in the second quarter; expected cash runway into mid-2027.

Raised net proceeds of $93.3 million in the second quarter from sales of common stock through Sana’s ATM and equity financing.

Second Quarter 2026 Financial Results

GAAP Results

Cash Position: Cash, cash equivalents, and marketable securities as of June 30, 2026 were $160.5 million compared to $138.4 million as of December 31, 2025. The increase of $22.1 million was primarily due to net proceeds from equity financings of $93.3 million, partially offset by cash used in operations of $70.2 million and cash used for the purchase of property and equipment of $1.9 million.
Research and Development Expenses: For the three and six months ended June 30, 2026, research and development expenses, inclusive of non-cash expenses, were $30.7 million and $59.4 million, respectively, compared to $29.8 million and $67.0 million for the same periods in 2025. The increase of $0.9 million for the three months ended June 30, 2026 compared to the same period in 2025 was primarily due to increased research, laboratory, and clinical development costs for our SC451 and SG293 programs and increased third-party manufacturing costs at contract development and manufacturing organizations (CDMOs) for our SC451 and SG293 programs, partially offset by lower personnel and other facility and allocated costs. The decrease of $7.6 million for the six months ended June 30, 2026 compared to the same period in 2025 was primarily due to lower personnel-related expenses, including non-cash stock-based compensation, lower facility and other allocated costs, and decreased third-party manufacturing costs at CDMOs due to costs incurred in the first half of 2025 for the suspended allogeneic CAR T programs that did not recur in 2026. These decreases were partially offset by increased third-party manufacturing costs at CDMOs for our SC451 and SG293 programs. Research and development expenses include non-cash stock-based compensation of $3.2 million and $6.3 million for the three and six months ended June 30, 2026, respectively, compared to $4.2 million and $8.8 million for the same periods in 2025.
Research and Development Related Success Payments and Contingent Consideration: For the three and six months ended June 30, 2026, Sana recognized non-cash expenses of $23.9 million and $32.3 million, respectively, compared to $10.3 million and $12.2 million for the same periods in 2025, in connection with the change in the estimated fair value of the success payment liabilities and contingent consideration in aggregate. The value of these potential liabilities may fluctuate significantly with changes to the probabilities of achieving clinical development or regulatory milestones with respect to a fusosome product candidate, and Sana’s market capitalization and stock price.
General and Administrative Expenses: General and administrative expenses for the three and six months ended June 30, 2026, inclusive of non-cash expenses, were $10.8 million and $22.2 million, respectively, compared to $10.3 million and $21.8 million for the same periods in 2025. The increases for each of the three and six months ended June 30, 2026 and 2025 were primarily due to increases in facility and other allocated costs. General and administrative expenses include non-cash stock-based compensation of $2.2 million and $4.7 million for the three and six months ended June 30, 2026, respectively, compared to $2.4 million and $4.8 million for the same periods in 2025.
Impairment of Long-Lived Assets: For each of the three and six months ended June 30, 2025, non-cash impairment of long-lived assets was $44.6 million. There was no impairment of long-lived assets for the three and six months ended June 30, 2026. The non-cash impairment in 2025 was primarily related to Sana’s manufacturing facility in Bothell, Washington and certain laboratory and office space in Seattle, Washington. In the second quarter of 2025, because of increased availability of manufacturing capacity at third-party CDMOs for cell and gene therapy products, together with progress in understanding our near-term manufacturing needs, we determined that CDMOs could meet our manufacturing requirements. Accordingly, we suspended further build-out of our internal manufacturing capabilities and continue to rely on CDMOs to meet our manufacturing needs at present.
Net Loss: Net loss for the three and six months ended June 30, 2026 was $63.6 million, or $0.22 per share, and $110.8 million, or $0.39 per share, respectively, compared to $93.8 million, or $0.39 per share, and $143.2 million, or $0.60 per share, for the same periods in 2025.

(Press release, Sana Biotechnology, AUG 10, 2026, View Source [SID1234669911])

On August 10, 2026 Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, reported financial results for the second quarter ended June 30, 2026, and provided a review of recent accomplishments and anticipated upcoming developments.

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Vlad Coric, M.D., Chairman and Chief Executive Officer of Biohaven, commented, "What excites me most about Biohaven today is that we’re no longer talking about scientific promise—we’re watching new therapeutic approaches begin to work in patients. This year we’ve crossed important milestones across our portfolio, including advancing BHV-1300 into pivotal development for Graves’ disease and generating compelling patient data from both our Graves’ disease and IgA nephropathy programs. We believe our MoDE and TRAP platforms are doing something fundamentally different: selectively removing the proteins that drive disease while preserving normal immune function. If these data continue to translate into larger studies, extracellular protein degradation has the potential to reshape how autoimmune diseases are treated."

Dr. Coric continued, "Opakalim represents another example of our commitment to solving difficult biological problems with precision. For decades, patients with epilepsy have often had to choose between seizure control and living with burdensome central nervous system side effects like somnolence, dizziness, and cognitive impairment. Our goal is to change that equation. Across studies to date, opakalim has consistently demonstrated the potential to deliver meaningful seizure reduction with a differentiated tolerability profile from existing therapies. As we approach our pivotal readout later this year, we believe we have the opportunity to introduce an important new treatment option for patients who deserve both seizure control and the ability to fully participate in their everyday lives."

Second Quarter 2026 and Recent Business Highlights

Presented new patient data from the MoDE platform in Graves’ disease; initiated pivotal study: In May 2026, the Company presented new clinical data from an ongoing Phase 1b study of BHV-1300 in patients with Graves’ disease. In the study, weekly administration of BHV-1300 1000 mg subcutaneously achieved mean reductions of pathogenic TSHR-IgG1 autoantibodies of greater than 80% by week 12 in patients with Graves’ hyperthyroidism. Among participants with elevated thyroid hormones despite concurrent anti-thyroid drug therapy, normalization of free T4 occurred at a median of 3 weeks, and normalization of free T3 occurred at a median of 5 weeks after the first administration of BHV-1300. To date, BHV-1300 has been safe and well-tolerated through 12 weeks of dosing, with most AEs mild and self-resolving, no SAEs, no clinically significant increases in cholesterol or ALT/AST/bilirubin, no clinically significant reductions in albumin, and no clinically significant reductions in IgG3, IgA, IgE, or IgM relative to baseline. Based upon these Phase 1b results, we have initiated a pivotal trial of BHV-1300 in Graves’ disease and expect to pursue additional follow-on studies in other autoimmune diseases. The Phase 3 study is designed to evaluate the ability of BHV-1300 to rapidly and selectively eliminate disease-causing autoantibodies while preserving the remainder of the immune system.
Presented additional patient data supporting the TRAP degrader platform in IgA nephropathy: In May 2026, the Company reported updated Phase 1b data from our ongoing study of BHV-1400 in patients with IgAN. BHV-1400 administered subcutaneously achieved mean reductions of pathogenic Gd-IgA1 of greater than 60% within 48 hours and approximately 70% within the first month of dosing. These reductions were deeper than those reported for BAFF/APRIL inhibitors, APRIL inhibitors, and CD38 inhibitors at comparable early time points. Reductions in Gd-IgA1 were associated with increases in eGFR, decreases in spot UPCR, and resolution of hematuria. Effects were selective, with no clinically significant reductions in other immunoglobulins (IgA, IgG, IgE, or IgM). To date, BHV-1400 has been safe and well-tolerated throughout one month of dosing, with most AEs mild and self-resolving, no SAEs, and no clinically significant increases in ALT, AST, or bilirubin. A pivotal study is expected to initiate in 2H 2026.
Continued advancement of Biohaven’s extracellular degrader pipeline: Biohaven continues to expand its leadership in extracellular targeted protein degradation with multiple MoDE and TRAP programs advancing across autoimmune diseases. In addition to ongoing development of BHV-1300 in Graves’ disease and BHV-1400 in IgA nephropathy, the Company continues advancing additional degrader candidates targeting IgG4-mediated disease, PLA2R autoantibodies, pro-insulin autoantibodies and other pathogenic extracellular proteins, broadening the potential impact of its proprietary platform.
Presented clinical data update with opakalim (BHV-7000) across multiple epilepsy types: In May 2026 at the Company’s annual R&D Day, the Company reported new clinical data for opakalim, a selective Kv7 activator, demonstrating durable seizure control and a differentiated tolerability profile across multiple epilepsy populations. In a proof-of-concept study in idiopathic generalized epilepsy (IGE), with a time-to-event design, the median time to the second generalized tonic-clonic seizure was 141 days with opakalim versus 47 days with placebo, with 33% of treated participants completing the 24-week double-blind period without a second seizure. Updated data from the ongoing open-label extension study in focal epilepsy showed that 54% of participants achieved a ≥50% reduction in seizure frequency over any consecutive six-month treatment period (n>100), while opakalim continued to demonstrate a favorable safety profile with a low incidence of CNS adverse events. Topline results from the Phase 2/3 RISE3 trial in focal epilepsy are expected during 2H 2026.
Continued advancement of Biohaven’s oncology portfolio: In July 2026, the Company announced that new data on BHV-1530, its FGFR3-directed antibody-drug conjugate (ADC) using a novel topoisomerase I (TopoIx) payload, will be presented at the ESMO (Free ESMO Whitepaper) Congress 2026. The new Phase 1 data will provide a clinically meaningful update to the early Phase 1 data initially disclosed at Biohaven’s R&D Day in May 2026 and will include signals of clinical activity demonstrated in the ongoing Phase 1, open-label, dose-escalation study of BHV-1530 in patients with advanced solid tumors. The data from May 27, 2026, showed early signs of antitumor activity in patients with both FGFR3-altered and wild-type overexpressing tumors, and across multiple tumor types. The Company also announced a new clinical supply agreement with Regeneron to evaluate BHV-1530 in combination with Libtayo. This agreement builds upon the existing clinical supply agreement between Biohaven and Regeneron for BHV-1510, a next-generation TROP2-directed ADC, further deepening the collaborative relationship between the two companies across Biohaven’s oncology pipeline.
Completed enrollment in Phase 2 obesity study with taldefgrobep alfa: Taldefgrobep alfa targets the myostatin/activin pathway with the goal of producing high-quality weight loss while preserving lean muscle mass. Unlike therapies designed primarily to maximize weight reduction, Biohaven believes preservation of skeletal muscle may translate into greater metabolic health, improved physical function, and more durable long-term treatment outcomes.
Reported first-in-human (FIH) dosing of oral PKM2 modulator, BHV-8100, targeting metabolic restoration and immunomodulation: In June 2026, the Company announced the initiation of FIH dosing for BHV-8100, its oral, brain-penetrant pyruvate kinase M2 isoform (PKM2) modulator. PKM2 modulation offers a potential new paradigm for treating large, underserved, and high-value indications in neurology, ophthalmology, and immunology and exhibits robust beneficial effects across a spectrum of preclinical models of Alzheimer’s, and multiple sclerosis, specifically by restoring metabolic deficits, reducing inflammation and neurodegeneration, and enhancing remyelination.
Advanced Parkinson’s disease program with BHV-8000: Enrollment continues in the Company’s global pivotal Phase 2/3 study evaluating BHV-8000, its orally administered, brain-penetrant, highly selective TYK2/JAK1 inhibitor for early Parkinson’s disease. BHV-8000 is designed to modulate neuroinflammation, a central driver of disease progression, and peripheral immune dysregulation.
Expected Upcoming Milestones:

We believe Biohaven is well positioned to achieve significant milestones in the second half of 2026 across numerous programs:

Selective Kv7 Ion Channel Activator (Opakalim):

Continue two Phase 2/3 studies in focal epilepsy; topline results for the first study expected in 2H 2026.
Myostatin-Activin Pathway Inhibitor (Taldefgrobep alfa):

Completed enrollment in Phase 2 study in obesity in 1Q 2026.
Lead TRAP and MoDE Extracellular Protein Degraders (BHV-1400 and BHV-1300)

BHV-1300: Continue enrolling patients in ongoing Phase 3 study in Graves’ disease following June 2026 study initiation. The study is a randomized, double-blind, placebo-controlled study in approximately 300 adults with Graves’ hyperthyroidism evaluating normalization of T3, T4, and TSH at 26 weeks absent an antithyroid drug.
BHV-1400: Pivotal study initiation in IgAN study targeted for 2H 2026.
Capital Position:

Cash, cash equivalents, marketable securities and restricted cash as of June 30, 2026, totaled approximately $270.5 million.

Second Quarter 2026 Financial Highlights:

Research and Development (R&D) Expenses: R&D expenses, including non-cash share-based compensation costs, were $100.8 million for the three months ended June 30, 2026, compared to $184.4 million for the three months ended June 30, 2025. The decrease of $83.6 million was primarily due to decreases in direct program spend and preclinical spend in 2026 as compared to the same period in the prior year. The decrease in direct program spend was largely due to our strategic reprioritization of programs, which was implemented in the fourth quarter of 2025, as well as one-time developmental milestones recorded during the three months ended June 30, 2025 of $15.0 million and $10.0 million for our BHV-8000 and BHV-1530 programs, respectively. Non-cash share-based compensation expense was $12.0 million for the three months ended June 30, 2026, a decrease of $1.1 million as compared to the same period in 2025.

General and Administrative (G&A) Expenses: G&A expenses, including non-cash share-based compensation costs, were $24.1 million for the three months ended June 30, 2026, compared to $27.3 million for the three months ended June 30, 2025. The decrease of $3.2 million was primarily due to decreased legal costs and employee costs, including non-cash share based compensation expense. Non-cash share-based compensation expense was $7.2 million for the three months ended June 30, 2026, a decrease of $0.5 million as compared to the same period in 2025.

Other (Expense) Income, Net: Other (expense) income, net was other expense, net of $12.0 million for the three months ended June 30, 2026, compared to other income, net of $13.8 million for the three months ended June 30, 2025. The decrease of $25.8 million was primarily due to increased non-cash losses during the three months ended June 30, 2026 related to changes in fair value of our notes payable liability under the Note Purchase Agreement with Beetlejuice SA LLC, an affiliate of Oberland Capital Management LLC, entered into during the second quarter of 2025 (the NPA), and gains recorded during the three months ended June 30, 2025 for the non-cash changes in fair value of our forward contracts and derivative liabilities recorded in connection with the amendment to our Membership Interest Purchase Agreement with Knopp Biosciences LLC in May 2024 (the Knopp Amendment).

Net Loss: Biohaven reported a net loss for the three months ended June 30, 2026 of $137.3 million, or $0.91 per share, compared to $198.1 million, or $1.94 per share, for the same period in 2025. Non-GAAP adjusted net loss for the three months ended June 30, 2026 was $118.1 million, or $0.78 per share, compared to $166.4 million, or $1.63 per share, for the same period in 2025. These non-GAAP adjusted net loss and non-GAAP adjusted net loss per share measures, more fully described below under "Non-GAAP Financial Measures," exclude non-cash share-based compensation charges and losses from the change in fair value of derivatives. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the tables below.

(Press release, Biohaven Pharmaceutical, AUG 10, 2026, View Source [SID1234669912])

On August 9, 2026 Innovent Biologics, Inc. (01801.HK) and Daiichi Sankyo (TSE: 4568), reported to have entered into an exclusive agreement for the commercialization of Vanflyta (quizartinib) in China.

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Under the terms of the agreement, Daiichi Sankyo will be responsible for the development, manufacturing and supply of Vanflyta while Innovent Biologics holds sole commercialization rights for Vanflyta in China, leading market promotion.

VANFLYTA was approved in China in June 2026 for use in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive as detected by an adequate validated diagnostic test, based on the results from the QuANTUM-First trial1.

"This collaboration with Daiichi Sankyo represents an exciting milestone for our hematology franchise. Innovent has continued to expand its product footprint in this field, building a diversified portfolio and strong market presence including TYVYT (sintilimab injection), HALPRYZA (rituximab injection), olverembatinib, FUCASO (Equecabtagene Autoleucel Injection), Jaypirca (pirtobrutinib), and the addition of VANFLYTA will further enhance our synergistic offerings," said Vivian Zhang, Executive Director, Chief Commercial Officer, Innovent Biologics. "Vanflyta (quizartinib) will be the 20th product in Innovent’s commercialized product portfolio. Through collaborative efforts, we aim to bring forward innovative medicines to benefit patients with cancer and further strengthen our leadership in oncology."

"The partnership with Innovent Biologics reflects our commitment to delivering innovation to patients in China," said Michio Hayashi, China President, Daiichi Sankyo. "By combining our research and development capabilities with Innovent’s commercial capabilities in China, we believe this collaboration can accelerate access to VANFLYTA for patients with newly diagnosed FLT3-ITD-positive AML and ultimately help improve outcomes in this high-risk patient population."

About FLT3-ITD Positive Acute Myeloid Leukemia
More than 487,000 new cases of leukemia were reported globally in 2022, with more than 305,000 deaths.2 AML accounts for 23.1% of total leukemia cases worldwide and is most common in adults.3,4 In China, nearly 82,000 people were diagnosed with leukemia in 2022 and more than 50,000 people died from the disease, making it the tenth deadliest cancer.5 AML is a common and aggressive subtype, accounting for approximately 50% of leukemia cases in China.6

A number of gene mutations have been identified in AML and FLT3 (FMS-like tyrosine kinase 3) mutations are the most common.7 Approximately 80% of FLT3 mutations are FLT3-ITD mutations, which drive cancer growth and contribute to particularly unfavorable prognosis, including increased risk of relapse and shorter overall survival. 7,8 FLT3-ITD mutations occur in about 25% of all AML cases.9

About Vanflyta
Vanflyta (quizartinib) is an oral, highly potent type II FLT3 inhibitor that targets FLT3-ITD mutations.

(Press release, Innovent Biologics, AUG 9, 2026, https://www.prnewswire.com/news-releases/innovent-biologics-and-daiichi-sankyo-enter-exclusive-agreement-for-vanflyta-commercialization-in-china-302846648.html [SID1234669885])

On August 9, 2026 HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company developing next-generation immunotherapies for oncology and immune-mediated diseases, reported that its wholly owned Taiwan subsidiary has entered into a strategic collaboration with the research team led by Professor Sung-Liang Yu of National Taiwan University, a key participating team in the Taiwan Cancer Moonshot Program (TCMP). The collaboration has been formalized through a memorandum of understanding signed by HanchorBio Taiwan and Professor Yu’s team.

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HanchorBio Chairman Scott Liu (left) and Professor Sung-Liang Yu (right), Chair of the Department of Clinical Laboratory Sciences and Medical Biotechnology at National Taiwan University, signed a Memorandum of Understanding (MOU) today to establish a joint research and development collaboration.
HanchorBio Chairman Scott Liu (left) and Professor Sung-Liang Yu (right), Chair of the Department of Clinical Laboratory Sciences and Medical Biotechnology at National Taiwan University, signed a Memorandum of Understanding (MOU) today to establish a joint research and development collaboration.

This strategic collaboration represents an important step in HanchorBio’s evolution from a clinical-stage immunotherapy company toward a precision immunotherapy platform integrating patient-derived biological insights, biomarker strategies, proprietary therapeutic engineering, and global clinical development capabilities.

By combining TCMP’s internationally recognized cancer multi-omics and translational research capabilities with HanchorBio’s FBDB (Fc-Based Designer Biologics) platform and clinical-stage pipeline, the parties aim to accelerate the development of biomarker-driven immunotherapies and improve the precision of clinical development strategies.

Connecting Discovery, Biomarkers, and Clinical Development

The Taiwan Cancer Moonshot is an Academia Sinica-led precision-oncology research program that brings together investigators from Academia Sinica, National Taiwan University, and leading clinical institutions to characterize the molecular biology of cancers affecting Taiwanese and broader Asian populations.

The project has established capabilities in cancer genomics, proteomics, integrated multi-omics analysis, clinically annotated patient-derived datasets, and biomarker discovery. The project has also contributed to international cancer proteogenomics research involving the U.S. National Cancer Institute’s Clinical Proteomic Tumor Analysis Consortium (CPTAC) and the International Cancer Proteogenome Consortium. These efforts have generated important insights into cancer biology across different populations, including landmark studies of major cancers in Taiwan, lung adenocarcinoma published in Cell 2020, a cross-population analysis of lung adenocarcinoma across Asian, North American, and Eastern European cohorts, published in Cancer Cell 2025, gastric cancer published in Gut 2026 and breast cancer published in Molecular Cancer 2026.

Strengthening Clinical Development and Through Biological Precision

As immunotherapy advances beyond single checkpoint inhibition, understanding which patients are most likely to benefit and why has become increasingly important.

Through this collaboration, HanchorBio and Professor Yu’s team will explore how integrated molecular and immune profiling can support next-generation immunotherapy development, including:

Identification of potential biomarkers associated with treatment response, resistance, and patient selection;
Understanding how tumor biology influences innate and adaptive immune responses;
Evaluating the relationship between macrophage-mediated immune regulation, T-cell functional states, and therapeutic outcomes;
Integrating patient-derived molecular insights with clinical development strategies for HanchorBio’s pipeline.
These capabilities may help improve clinical trial design, enhance translational understanding, and support more precise development approaches for next-generation immunotherapies.

Building a Differentiated Precision Immunotherapy Platform

"The Taiwan Cancer Moonshot has established internationally recognized excellence in cancer proteogenomics, multi-omics, and patient-derived translational research, particularly in Asian cancer populations," said Scott Liu, PhD, Founder and Chairman of HanchorBio. "The significance of this strategic collaboration is that it brings TCMP’s capabilities directly into the drug-development process. By connecting Professor Yu’s expertise and the TCMP’s resources with HanchorBio’s clinical-stage portfolio and FBDB platform, we aim to answer specific development questions: which patients are most likely to benefit, what biology drives response or resistance, and how biomarker strategies can make clinical development more precise. This includes understanding how tumor-intrinsic biology, macrophage-mediated immune regulation, and adaptive immune responses, including T-cell functional states, contribute to treatment response, resistance, and durability. Our goal is to translate patient-derived molecular insights into better development strategies and ultimately better therapies."

From Patient-Derived Discovery to Precision Immunotherapy

Chair and Professor Sung-Liang Yu of Department of Clinical Laboratory Sciences and Medical Biotechnology, National Taiwan University said:

"The Taiwan Cancer Moonshot has generated extensive molecular and clinical insights through the systematic study of cancers affecting Taiwanese and East Asian populations. Collaboration with a clinical-stage biotechnology company creates an important opportunity to evaluate these discoveries in the context of defined therapeutic mechanisms and active drug-development programs. By combining patient-derived research and multi-omics analysis with HanchorBio’s drug-development capabilities, we aim to shorten the path from scientific discovery to biomarkers, patient-selection strategies, and potential clinical applications."

Together, the parties aim to establish a translational model:

PATIENT-DERIVED DISCOVERY → MOLECULAR & IMMUNE INSIGHT → BIOMARKER-GUIDED CLINICAL DEVELOPMENT → PRECISION IMMUNOTHERAPY

Strategic Significance of HanchorBio

This collaboration strengthens three strategic pillars of HanchorBio’s long-term value creation:

Improving clinical development precision
By integrating patient-derived molecular data and immune profiling, HanchorBio aims to improve understanding of treatment response, resistance mechanisms, and patient selection strategies.
Expanding platform differentiation
The combination of discovery capabilities, biomarker strategies, FBDB therapeutic engineering, and clinical development creates a differentiated precision immunotherapy ecosystem beyond individual drug candidates.
Supporting global innovation from Taiwan
The collaboration connects Taiwan’s internationally recognized cancer research capabilities with a globally oriented clinical-stage biotechnology company, supporting the translation of Taiwan-originated scientific innovation into global therapeutic development.

(Press release, Hanchor Bio, AUG 9, 2026, View Source [SID1234669886])

On August 7, 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 and topically delivered therapeutics for squamous and basal cell skin cancers, reported financial results and business highlights for the quarter ended June 30, 2026.

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Q2 2026 Highlights and Recent Events

● CyPath Lung diagnostic test volume increased 216% during the second quarter of 2026 compared to the second quarter of 2025.

● CyPath Lung testing revenue for the first six months of 2026 increased 159% to approximately $835,000, compared with approximately $323,000 for the first six months of 2025.

● The Company delivered 1,097 CyPath Lung test reports during the first six months of 2026, compared with 390 during the same period of 2025.

● The number of physician offices and clinics ordering CyPath Lung for their patients increased 122% during the second quarter of 2026 compared to the same period in 2025.

● Existing clients as of June 30, 2025, increased their CyPath Lung orders by 71% year over year during the first six months of 2026.

● The longitudinal clinical trial designed to evaluate the clinical performance of the CyPath Lung test has begun patient enrollment at 11 clinical sites, including nine Department of Veterans Affairs (VA) and military medical centers. Financial support for the trial has been provided by 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.

● Positive preliminary therapeutic data support the development of topical treatments for squamous and basal cell skin cancers, with self-delivering stabilized siRNAs selectively killing melanoma, squamous and basal carcinoma cells while sparing healthy cutaneous cells.

● bioAffinity presented positive research results advancing its diagnostic platform designed to identify antibody drug receptors in sputum to match patients with the most appropriate biologic therapies, including receptors for dupilumab, a leading therapy for asthma and chronic obstructive pulmonary disease (COPD), and benralizumab, another asthma therapy.

● The Company published a comprehensive clinical review and white paper authored by Chief Medical Officer Gordon H. Downie, MD, PhD, that presents a practical clinical framework for incorporating CyPath Lung into pulmonary nodule evaluation and cancer surveillance.

● The Company announced a collaboration with Pictor, Inc., a targeted proteomic platform company, to support development and commercialization of bioAffinity Technologies’ next-generation diagnostic tests designed to provide a more complete picture of lung inflammation in patients with asthma and COPD.

● The Society for Advanced Bronchoscopy (SAB) and National Association of Veterans Research Education Foundations (NAVREF) hosted webinars featuring multi-disciplinary panels of physicians who discussed CyPath Lung’s expanding role in the lung nodule care continuum.

● bioAffinity received notification of allowance from the Mexican Institute of Industrial Property for a patent application protecting the use of defined antibodies and the porphyrin TCPP to label cell populations in sputum and the use of flow cytometry to determine the presence of lung cancer cells in sputum.

● In June 2026, bioAffinity completed a public offering that generated approximately $3.2 million in gross proceeds to support commercialization activities, clinical development, and general corporate purposes.

Management Commentary

"Our commercial strategy continues to gain significant traction as physicians increasingly recognize the clinical value of CyPath Lung for evaluating patients at high risk for lung cancer and surveilling lung cancer survivors for recurrence," said Maria Zannes, President and Chief Executive Officer of bioAffinity Technologies. "During the second quarter, CyPath Lung test volume surged 216% year-over-year. This growth reflects accelerating physician adoption and clinical confidence in our technology. As more clinics integrate CyPath Lung into their standard of care workflows, peer-to-peer education is a powerful driving force behind building broader awareness of the test’s ability to provide objective data that complements traditional imaging and supports faster, more informed clinical decisions."

Ms. Zannes continued, "Alongside our commercial momentum, we achieved critical milestones across our strategic roadmap. In the second quarter, we expanded physician education initiatives, including scientific presentations, webinars, podcasts and real-world clinical case studies. We continued to make progress in our large-scale longitudinal study that includes VA and military medical centers, expanding our outreach to veterans. By leveraging our expertise in flow cytometry and AI and our work with siRNAs, we are building a robust pipeline of precision diagnostics for the large asthma and COPD markets and even larger therapeutic markets for topically delivered drugs that treat squamous and basal cell skin cancers."

Ms. Zannes concluded, "Looking ahead, our priorities for the second half of 2026 are expanding physician adoption, increasing utilization among existing customers, and introducing CyPath Lung to new healthcare systems and specialty practices, including oncology. The positive results we see from research and development of precision diagnostics and a therapeutic for skin cancers are exciting as we advance our pipeline. We believe this balanced approach positions bioAffinity to create lasting value for patients, healthcare providers and shareholders."

Second Quarter 2026 Financial Results

Revenue for the quarter ended June 30, 2026, was $1.5 million, a 19% increase from the $1.3 million reported for the same period in 2025. The increase is primarily due to an increase in sales of CyPath Lung.

Operating expenses for the second quarter of 2026 were $4.8 million, compared with $3.8 million in the second quarter of 2025.

● Direct costs and expenses for the second quarter of 2026 were $1.1 million, compared to $1 million in the prior-year period, primarily reflecting higher CyPath Lung test volume.

● Research and development expenses increased 16% year-over-year to $362,000, driven by laboratory supply purchases and costs associated with relocating the research and development lab from the University of Texas at San Antonio to the Precision Pathology Laboratory services campus.

● Clinical development expenses rose to $476,000 from $129,000 in the second quarter of 2025 due to costs associated with initiating the longitudinal clinical study.

● Selling, general and administrative expenses were $2.9 million for the second quarter of 2026, up from $2.2 million in the same period last year. The increase was primarily driven by higher employee compensation, reflecting the addition of sales and administrative personnel to support the expanding commercialization of CyPath Lung.

Net loss for the quarter ended June 30, 2026, was $3.4 million, compared with a net loss of $4.1 million for the second quarter of 2025.

Cash and cash equivalents as of June 30, 2026, were $2.4 million, compared with $6.4 million as of December 31, 2025.

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. In a published clinical trial of high-risk patients, CyPath Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value (NPV) in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. The high NPV gives physicians greater confidence that a negative result is truly negative, potentially sparing patients from unnecessary invasive and costly procedures. CyPath Lung is marketed as a Laboratory Developed Test (LDT) and is not intended for use as a sole diagnostic tool and should be considered alongside other clinical findings.

(Press release, BioAffinity Technologies, AUG 7, 2026, View Source [SID1234669870])