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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 Purple Biotech Ltd. ("Purple Biotech" or the "Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing a next-generation immunotherapy platform designed to maximize anti-cancer potency while minimizing toxicity, reported financial results for the three and twelve months ended December 31, 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In 2025, we focused on the CAPTN-3 platform and the value it can generate for patients and shareholders, naming a second tri-specific antibody from the platform, IM1305, and strengthening the preclinical data package for the first tri-specific antibody, IM1240. In addition, the capital we raised in 2025 is expected to provide runway into 2027, covering preparations for IM1240 Phase 1 study initiation," said Gil Efron, Purple Biotech CEO. "During the past year, we made efforts to partner both CM24 and NT219 and, as previously reported, we will not be able to continue developing these assets until we obtain a strategic investment or a partner."

"We are excited by the increasing interest in modalities such as T cell engagers (TCEs) and masked antibodies, both features of the CAPTN-3 tri-specific platform. With a cash position of $9.5 million at the end of 2025, and with data demonstrating that tri-specific antibodies from the CAPTN-3 platform deliver in vivo efficacy, a favorable therapeutic window, and scalable manufacturability, we look forward to sharing additional data and advancing the program over the course of this year," Gil concluded.

Q4 2025 and Recent Clinical & Corporate Highlights:

New data on the CAPTN-3 platform were presented at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2025, with CAPTN-3’s two lead tri-specific antibodies:

● Demonstrated significant and sustained tumor regression with two distinct tri-specific antibodies from the CAPTN-3 platform, IM1240 and IM1305, targeting different tumor antigens

● Transcriptomic analysis across ~11,000 TCGA samples showed that NKG2A expression is strongly associated with tumor expression of 5T4 or TROP2, supporting the inclusion of the NKG2A arm in CAPTN-3 designs

● NKG2A arm significantly contributes to IM1240 anti-cancer immune activity in PD1-resistant patient-derived explants

Toxicology study demonstrated an expanded therapeutic window for IM1240 (capped-CD3x5T4xNKG2A)

● IM1240 demonstrated improved tolerability in a toxicology study at doses up to 300-fold higher than a non-capped comparator, with significantly reduced immune-related toxicity, including minimal cytokine release. These results highlight the unique safety profile of this approach, which may address a key limitation of certain current T-cell engagers, where cytokine release syndrome can restrict dosing

● IM1240’s pharmacokinetic profile showed increased systemic exposure and a prolonged circulating half-life, enabled by its human serum albumin moiety and capping design

Achieved manufacturing milestone for IM1240

● Achieved commercially viable yield for IM1240, positioning the program competitively for anticipated future development

● Validates the potential scalability of the CAPTN-3 tri-specific antibody platform

Financial Results for the Three Months Ended December 31, 2025

Research and Development Expenses were $1.8 million, an increase of $1.4 million, compared to $0.5 million in the same period of 2024, primarily due to CAPTN-3 platform CMC (chemistry, manufacturing, and controls) development activities.

General and Administrative Expenses were $1.1 million, compared to $0.6 million in the same period of 2024, an increase of $0.6 million, primarily attributable to increased professional services fees and higher cash and non-cash compensation expenses.

Impairment Loss Expenses were $20.5 million for the period, in connection with the impairment of in-process research and development assets related to CM24 and NT219 as of December 31, 2025. Following the Company’s determination that the continued development of CM24 and NT219 is contingent upon partnering or the availability of additional financing under the circumstances, and in light of the Company’s focus of its development efforts on CAPTN-3, the Company determined that the recoverable value of the CM24 and NT219 assets was less than their carrying value, resulting in the recognition of $20.5 million of impairment charges related to these programs.

Operating Loss was $23.4 million, an increase of $22.4 million, compared to $1.0 million in the same period of 2024, primarily reflecting the $20.5 million non-cash impairment expenses recognized during the period.

Adjusted Operating Loss (as reconciled below) was $2.9 million, compared to $1.0 million in the same period of 2024 primarily reflecting the increase in CAPTN-3 platform development activities.

Financial Expenses, Net, were $0.2 million, compared to financial income of $0.6 million in the same period of 2024, primarily due to fair value adjustments of warrants and foreign exchange rate fluctuation

Net Loss was $23.6 million, an increase of $23.1 million, compared to $0.4 million in the same period of 2024, primarily reflecting the $20.5 million non-cash impairment expenses recognized during the period.

As of December 31, 2025, Purple Biotech had cash and cash equivalents and short-term deposits of $9.5 million, which is expected to provide the Company with a cash runway into 2027.

Financial Results for the Twelve Months Ended December 31, 2025

Research and Development Expenses were $3.7 million, a decrease of $3.9 million, compared to $7.6 million in the same period of 2024. The decrease was primarily due to lower clinical trial expenses, partially offset by CMC development activities related to the CAPTN-3 platform.

General and Administrative Expenses were $3.2 million, consistent with the same period of 2024.

Impairment Loss Expenses were $20.5 million for the year ended December 31, 2025. The Company determined that the recoverable value of the CM24 and NT219 assets was less than their carrying value as of December 31, 2025, resulting in the recognition of $20.5 million of impairment charges related to these programs. No impairment loss expenses were recognized in 2024.

Operating Loss was $27.5 million, an increase of $16.5 million, compared to $11 million in the same period of 2024, primarily reflecting the $20.5 million non-cash impairment expenses recognized during the period, partially offset by lower clinical trial expenses.

Adjusted Operating Loss (as reconciled below) was $6.7 million, compared to $10.4 million in the same period of 2024 primarily reflecting the decrease in clinical trial expenses.

Net Loss for the year ended December 31, 2025 was $26.4 million, or $54.9 loss per basic ADS, compared to a net loss of $7.2 million, or $44.4 loss per basic and diluted ADS, in the same period of 2024. The increase in net loss was primarily due to the $20.5 million non-cash impairment expenses recognized during the period.

(Press release, Purple Biotech, MAR 13, 2026, View Source [SID1234663538])

On March 12, 2026 IMPACT-AML reported that it has entered into an agreement with SELLAS Life Sciences Group, a late-stage clinical biopharmaceutical company focused on developing novel therapies for a broad range of cancer indications. Under the agreement, the IMPACT-AML network will conduct a clinical study evaluating SLS009, a highly selective CDK9 inhibitor, enabling access to multiple European clinical sites and patients.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

IMPACT-AML is a pan-European project that builds an inclusive clinical network, the STREAM platform, connecting patients, clinicians and researchers to test novel AML therapies and improve patient outcomes. It is part of the EU Mission on Cancer programme and represents a high-level scientific collaboration. The project is led by a consortium of major European research and clinical institutions, including IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" (IRST), the University of Bologna, IIS La Fe (Health Research Institute Hospital La Fe), several European AML collaborative groups, and supranational organisations under the umbrella of the European LeukemiaNet (ELN), as well as multiple university hospitals across Europe. By leveraging IMPACT-AML’s existing infrastructure and expertise, SELLAS expects to expand European patient access to SLS009 in a cost-efficient manner while supporting broader participation across the clinical programme.

"This is a highly meaningful milestone for SELLAS and for the SLS009 programme," said Angelos Stergiou, M.D., Sc.D., President and Chief Executive Officer of SELLAS. "Gaining access to the IMPACT-AML framework represents strong external validation of SLS009 and reflects growing recognition of its potential to address critical unmet needs in AML. Importantly, this collaboration allows us to expand our clinical programme into Europe efficiently by leveraging an established infrastructure, improving capital efficiency while supporting broader and faster patient enrolment as we advance into frontline AML".

The collaboration is expected to support continued execution of the SLS009 clinical programme as SELLAS advances into frontline AML. The European study is planned to enrol approximately 40 patients to evaluate SLS009 in combination with azacitidine and venetoclax (AZA/VEN) in patients with newly diagnosed AML with high-risk features. Enrolment in the first part of the trial for newly diagnosed patients is expected to begin at US sites in Q1 2026, followed by initiation at European sites in Q2 2026, subject to regulatory approval and site readiness.

"IMPACT-AML is committed to accelerating access to promising new therapeutic approaches for patients with AML who face limited treatment options," said IMPACT-AML Scientific Coordinator Dr Giovanni Martinelli. "We are pleased to collaborate with SELLAS and support the evaluation of SLS009 within our European network, in line with our mission to facilitate efficient, high-quality clinical research in AML."

(Press release, IMPACT-AML, MAR 12, 2026, View Source [SID1234663497])

On March 12, 2026 Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved antibody drug conjugate (ADC) cancer treatments, reported financial results for the fourth quarter and full-year ended December 31, 2025, and provided recent corporate highlights.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Last year marked our evolution into Whitehawk Therapeutics, a boldly pragmatic company developing the next generation of ADC cancer treatments. We progressed three programs through IND-enabling work in tandem, while building the capabilities required to execute efficiently in the clinic as we enter 2026," said Dave Lennon, PhD, President and CEO of Whitehawk Therapeutics. "Whitehawk combines established but underexploited tumor targets with a differentiated ADC platform. With two active Phase 1 studies for HWK-007 and HWK-016, and a third IND submission for HWK-206 planned mid-year, we are energized by the opportunity to translate our strategy into clinical data with the potential to have a meaningful impact for patients."

Q4 2025 and Recent Operational Highlights:

Advanced development of PTK7-targeted HWK-007 and MUC16-targeted HWK-016 into Phase 1. In January, Whitehawk announced regulatory progress for these programs, which are both now actively recruiting Phase 1 trials.
The HWK-007 Phase 1 trial will initially evaluate activity in lung and ovarian cancers, two PTK7-expressing tumor types with established precedent data, as well as endometrial cancer, one of the highest PTK7-expressing tumor types.
The HWK-016 Phase 1 trial will initially evaluate activity in two high MUC16-expressing gynecologic cancers, ovarian and endometrial.

Strengthened management with new CMO. In December 2025, Whitehawk appointed Margaret Dugan, MD, as Chief Medical Officer (CMO). Dr. Dugan brings more than 30 years of global oncology drug development experience, with extensive expertise in early-stage clinical development and regulatory strategy.

Presented real-world analysis confirming PTK7 as a broadly expressed, clinically relevant target across solid tumors. Whitehawk presented data at the AACR (Free AACR Whitepaper)-NCI-EORTC meeting that established PTK7 as the third most highly expressed tumor marker among clinically validated and emerging ADC targets, present in ~70% of tumors. We believe these findings support the potential of PTK7 as a pan-tumor target.
Fourth Quarter and Full Year 2025 Financial Results:

Cash, cash equivalents and short-term investments as of December 31, 2025, were $145.7 million as compared to $47.2 million as of December 31, 2024. Cash is anticipated to fund operations into 2028 based on current plans.

Net loss for the three months ended December 31, 2025, was $23.3 million as compared to $18.3 million for the three months ended December 31, 2024. Net loss for the full-year ended December 31, 2025, was $20.6 million, as compared to $63.7 million for the same period in 2024. The full-year net loss includes an $87.3 million gain on the divestiture of AADI Subsidiary.
Anticipated Milestones:

Preclinical data – expect to present preclinical data across the portfolio at an upcoming medical congress in Spring 2026.

HWK-206 – plan to submit an Investigational New Drug application to the U.S. Food and Drug Administration in mid-2026 for HWK-206 in small-cell lung cancer and neuroendocrine tumors; Phase 1 recruitment planned to start in Q3 2026.

HWK-007 and HWK-016 – ongoing recruitment into Phase 1 trials, with initial results expected in 1H 2027.

(Press release, Whitehawk Therapeutics, MAR 12, 2026, View Source [SID1234663516])

On March 12, 2026 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta ("γδ") T cell therapies and γδ T cell engagers for cancer and autoimmune diseases, reported financial results and business highlights for the fourth quarter and full-year ended December 31, 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In 2025, we delivered meaningful progress financially and across our clinical γδ T cell therapy programs and our next-generation T cell engager platform," said William Ho, co-founder and Chief Executive Officer of IN8bio. "Our deep knowledge of γδ T cell biology and their powerful immune properties enables us to create potential first-in-class or best-in-class programs to address significant unmet medical needs. Last year, we reported updated survival data from our INB-200 and 400 Phase 1 and 2 programs in GBM, along with data from a contemporaneously enrolled standard-of-care ("SOC") control group. Patients treated with our DeltEx DRI γδ T cells nearly doubled the mPFS, compared to the SOC group, despite a higher number of patients receiving only partial resections. These findings underscore the aggressive nature of GBM, even with SOC treatment, and highlight the significant need for new treatment options. Importantly, our recent financing strengthens our balance sheet and is expected to extend our cash runway to allow us to advance multiple high-value programs. With differentiated science, advancing clinical programs, and a novel TCE platform, we believe IN8bio is well positioned to achieve key milestones and deliver value to shareholders and patients in 2026."

Key Highlights

Strengthened Balance Sheet with up to $40.2 Million Private Placement

In December 2025, IN8bio announced a private placement of up to $40.2 million in gross proceeds, including $20.1 million in an initial closing and the potential for an additional milestone-based $20.1 million.

Financing led by Coastlands Capital, with participation from new and existing investors.
Net proceeds of $18.5 million expected to extend the Company’s cash runway into the first half of 2027.
Proceeds intended to support IND-enabling studies for INB-619 γδ TCE, further discussions with the FDA on potential clinical pathways for the GBM program, continued advancement of the Company’s γδ T cell therapy programs, and general corporate purposes.
Presented Updated Clinical Data Demonstrating Durable Survival Improvements in Newly Diagnosed Glioblastoma

In January 2026, IN8bio reported updated data from its INB-200 Phase 1 and INB-400 Phase 2 trials evaluating DeltEx DRI γδ T cells in newly diagnosed GBM. The data included a contemporaneous SOC control group from multiple clinical sites.

mPFS for repeat dose DeltEx DRI patients was 13.0 months vs. 6.6 months for SOC control cohort (+97% improvement).
Median overall survival ("mOS") in repeat dose patients had not yet been reached at 17.2+ months, surpassing the 13.2-month final mOS for SOC control arm.
Several patients remained progression-free beyond two years, and one grade 4 glioma patient remains progression-free for greater than 4.5 years, highlighting the long-term benefit of INB-200.
No dose-limiting toxicities ("DLTs"), cytokine release syndrome ("CRS"), neurotoxicity ("ICANS"), tumor inflammation-associated neurotoxicity ("TIAN") or other unexpected severe adverse events were observed.
Results reinforce the potential of repeat-dose γδ T cell therapy to meaningfully improve outcomes in newly diagnosed glioblastoma and support continued regulatory engagement regarding potential clinical pathways.
Continued Advancing Next-Generation Gamma-Delta T Cell Engager Platform

Continued advancing INB-600 platform, featuring novel γδ T cell engagers designed to potentially improve durability and safety compared with traditional CD3-targeting engagers.
Progressing INB-619, a CD19-targeting γδ T cell engager for potential use in oncology and autoimmune diseases into IND-enabling studies with initial animal data expected in 2026.
Presented encouraging preclinical data including complete B-cell depletion, robust γδ T cell expansion, and minimal CRS-associated cytokine release at The American College of Rheumatology ("ACR") Convergence 2025 meeting, supporting differentiation of the platform.
Leadership Update

In February 2026, IN8bio announced the promotion of Kate Rochlin, Ph.D., to President and Chief Operating Officer. Dr. Rochlin has played a central role in advancing the Company’s clinical and preclinical programs, manufacturing capabilities, and strategic execution, and will continue overseeing company operations as IN8bio advances its pipeline and prepares for its next phase of growth.

Anticipated Milestones

Guidance from the FDA on potential regulatory pathway by the second half of 2026
Additional clinical updates on our GBM programs, including final mOS data from the total data set, at medical meetings in mid- and late-2026
Initial preclinical animal data and additional IND-enabling data for INB-619 expected in the second half of 2026
Completion of patient dosing in INB-100 in early 2026 and report long-term follow-up results at a medical meeting in late 2026
Fourth Quarter and Full Year 2025 Financial Highlights

IN8bio significantly improved its financial profile in 2025, reducing its full-year net loss by 36% year-over-year and ending the year with more than double the cash on hand compared to the prior year.

Cash position: As of December 31, 2025, the Company had cash of $27.1 million, compared with $11.1 million as of December 31, 2024.
Research and Development (R&D) expenses: R&D expenses were $2.6 million for the three months ended December 31, 2025, compared with $3.6 million for the comparable prior year period. R&D expenses were $10.2 million for the year ended December 31, 2025, compared with $17.0 million in the prior year. Non-cash stock-based compensation expense included in R&D expense was $1.2 million for the full year 2025 and $0.3 million for the fourth quarter of 2025.
General and administrative (G&A) expenses: G&A expenses were $2.4 million for the three months ended December 31, 2025, compared with $2.6 million for the comparable prior year period. G&A expenses were $9.7 million for the year ended December 31, 2025, compared with $12.6 million in the prior year. Non-cash stock-based compensation expense included in G&A expense was $2.0 million for the full year 2025 and $0.4 million for the fourth quarter of 2025.
Severance and related charges: Severance and related charges were nil for the year ended December 31, 2025, compared with $1.1 million in the prior year.
Net loss: The Company reported a net loss of $4.9 million, or $0.45 per basic and diluted common share, for the three months ended December 31, 2025, compared with a net loss of $6.2 million, or $2.38 per basic and diluted common share, for the comparable prior year period. For the year ended December 31, 2025, net loss was $19.4 million, or $4.44 per basic and diluted common share, compared with a net loss of $30.4 million, or $17.05 per basic and diluted common share, for the prior year.
IN8bio enters 2026 with a strengthened balance sheet, advancing clinical programs, and multiple regulatory milestones ahead. The Company remains focused on generating meaningful clinical data, advancing its γδ T cell platforms toward key inflection points, and deploying capital efficiently across its highest-priority programs across oncology and autoimmune diseases.

(Press release, In8bio, MAR 12, 2026, View Source [SID1234663498])