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Johnson & Johnson highlights promising first-in-human Erda-iDRS (formerly TAR-210) results in intermediate-risk non-muscle-invasive bladder cancer

On March 13, 2026 Johnson & Johnson (NYSE:JNJ) reported results from an open-label, multicenter Phase 1 study evaluating an investigational intravesical drug-releasing system with erdafitinib (Erda-iDRS) in patients with intermediate-risk and high-risk non–muscle-invasive bladder cancer (NMIBC) whose tumors harbor select fibroblast growth factor receptor (FGFR) alterations. The study met its primary safety endpoint and demonstrated complete and durable responses in patients with recurrent intermediate-risk disease, along with encouraging recurrence-free outcomes in high-risk disease. These findings support continued development of this targeted approach with ongoing Phase 2 and Phase 3 studies evaluating Erda-iDRS across risk settings. Data were presented during a late-breaking oral session at the European Association of Urology (EAU) 2026 Annual Meeting (Abstract #LB26-0083).1

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FGFR alterations are common in early-stage bladder cancer, occurring in approximately 70 percent of intermediate-risk and 40 percent of high-risk non–muscle-invasive bladder cancer tumors.2,3 Because these changes may drive tumor growth, they represent an important therapeutic target in this setting. Erda-iDRS is designed to provide prolonged release of erdafitinib, an oral kinase inhibitor, directly into the bladder via intravesical administration over a three-month period, and may enable localized treatment while aiming to minimize systemic exposure and the risk of adverse events associated with oral administration.

"Intermediate-risk non–muscle-invasive bladder cancer is defined by recurrences, and many patients undergo repeated procedures as their tumors return," said Antoni Vilaseca Cabo,* M.D., adjunct physician of the Urology Service at Hospital Clínic de Barcelona in Spain, and presenting author. "In this study, treatment with Erda-iDRS led most patients with FGFR-altered disease to achieve a complete response by the end of the second treatment cycle, and many of those responses were sustained over time. Achieving and maintaining a complete response is particularly meaningful in this setting, where recurrence is common and requires repeated surgical intervention."

"For patients with FGFR-altered non–muscle-invasive bladder cancer, care has historically not been guided by precision-based approaches," said Christopher Cutie, M.D., Vice President, Disease Area Leader, Bladder Cancer, Johnson & Johnson. "The high and durable complete responses demonstrated with Erda-iDRS highlight the opportunity to deliver a targeted therapy to these patients. Bringing a biology-based approach into earlier stages of this disease has the potential to change how these patients are treated."

Detailed Study Results

In this Phase 1 study, Erda-iDRS was evaluated in patients with non–muscle-invasive bladder cancer harboring select FGFR alterations identified by urine and/or tissue testing. As of November 3, 2025, 62 patients with recurrent intermediate-risk non–muscle-invasive bladder cancer and 26 patients with recurrent, Bacillus Calmette-Guérin (BCG)-experienced, high-risk non–muscle-invasive bladder cancer had received treatment. The primary endpoint was safety, with the secondary endpoints assessing complete response rate and duration of CR in the intermediate-risk cohort and recurrence-free survival in the high-risk cohort.1

In the intermediate-risk cohort, Erda-iDRS was evaluated as a non-surgical treatment for visible tumors. The complete response rate was 89 percent (95 percent confidence interval [CI], 78-95), based on tumor assessments during the initial treatment period. Among responders, the median duration of complete response was 18 months (95 percent CI, 14-25), with a median follow-up of 18 months (range, 15-21), indicating prolonged responses over time. Forty-nine percent of patients remain in follow-up.1

In the high-risk cohort, patients treated with Erda-iDRS had a median recurrence-free survival of 20 months (95 percent CI, 15-30), with a 12-month recurrence-free survival rate of 83 percent (95 percent CI, 62-93). With a median recurrence-free survival follow-up of 24 months (range, 15-30), 31 percent of patients remain in follow-up.1

Treatment was generally well tolerated, as evidenced by the absence of dose-limiting toxicities and a safety profile characterized by predominantly local adverse events. In the combined cohorts, the most frequent treatment-related adverse events (TRAEs) were hematuria (32 percent) and dysuria (22 percent). Grade 3 or higher TRAEs occurred in four patients (5 percent). Eight patients (9 percent) discontinued treatment due to adverse events, and two patients (2 percent) experienced serious TRAEs. Pharmacokinetic analyses demonstrated prolonged drug levels in the urine, with limited systemic exposure and no observed hyperphosphatemia.1

Continued Development

Phase 2 and Phase 3 studies are ongoing to evaluate Erda-iDRS in intermediate- and high-risk non–muscle-invasive bladder cancer. The MoonRISe program includes the Phase 3 MoonRISe-1 study (NCT06319820) in intermediate-risk disease in the adjuvant setting (after tumor resection), the Phase 2 MoonRISe-2 study (NCT05316155) in intermediate-risk disease in the ablative setting (evaluating treatment of visible tumors without surgery), and the Phase 3 MoonRISe-3 study (NCT06919965) in patients with high-risk papillary non–muscle-invasive bladder cancer who received prior BCG therapy, including those with BCG-unresponsive disease, in the adjuvant setting.4,5,6

About Erdafitinib Intravesical Drug-Releasing System (Erda-iDRS)

Erda-iDRS is an investigational intravesical drug delivery system designed to deliver prolonged, localized erdafitinib, an oral kinase inhibitor, directly to the bladder. The safety and efficacy of Erda-iDRS are being evaluated in a Phase 1 study in patients with non–muscle-invasive bladder cancer (NMIBC), including those with high-risk, BCG-unresponsive disease and intermediate-risk disease with visible tumors. Additional Phase 2 and Phase 3 studies are ongoing to further assess Erda-iDRS across intermediate- and high-risk NMIBC.

In 2008, Janssen Pharmaceuticals entered into an exclusive worldwide license and collaboration agreement with Astex Pharmaceuticals to develop and commercialize erdafitinib.

About Non–Muscle-Invasive Bladder Cancer

Non–muscle-invasive bladder cancer (NMIBC) is an early stage of bladder cancer confined to the lining of the bladder. It accounts for approximately 75 percent of newly diagnosed bladder cancer cases. NMIBC is categorized as low-, intermediate-, or high-risk based on tumor characteristics and likelihood of recurrence or progression.7

Patients with intermediate-risk NMIBC experience frequent tumor recurrences that often require repeated procedures and ongoing monitoring. High-risk NMIBC carries a greater likelihood of progression to muscle-invasive disease, which may require radical cystectomy.8,9,10 Despite available treatments, recurrence and progression remain common across intermediate- and high-risk disease, underscoring the need for durable bladder treatment options.

(Press release, Johnson & Johnson, MAR 13, 2026, View Source;johnson-highlights-promising-first-in-human-erda-idrs-formerly-tar-210-results-in-intermediate-risk-nonmuscle-invasive-bladder-cancer-302713590.html [SID1234663541])

Xenetic Biosciences, Inc. Reports Full Year 2025 Financial Results

On March 13, 2026 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing difficult to treat cancers, reported its financial results for the year ended December 31, 2025.

Recent Highlights

Expanded and presented preclinical and translational evidence supporting neutrophil extracellular traps (NETs) as drivers of cancer progression and highlighting the therapeutic potential of Deoxyribonuclease (DNase) -based interventions;

Progressed investigator-initiated exploratory studies in Israel evaluating DNase I in combination with standard-of-care and immunotherapy platforms, including:

Ongoing pancreatic ductal adenocarcinoma (PDAC) study;

Proposed large B-cell lymphoma (LBCL) study in combination with Chimeric Antigen Receptor (CAR) T cell therapy;

Advanced clinical manufacturing activities for DNase I toward Investigational New Drug (IND) application;

Current focus on mechanism-of-action and translational research studies supported by encouraging CAR-T proof-of-concept studies with Scripps Research; and

Pursuing strategic alternatives to maximize shareholder value.

"During 2025, we continued to advance our DNase-based technology toward Phase 1 clinical development while making steady progress across scientific, operational and strategic fronts," said James Parslow, Interim Chief Executive Officer and Chief Financial Officer of Xenetic. "We strengthened the evidence linking NETs to cancer progression and the therapeutic promise of DNase-based strategies, advanced multiple investigator-initiated studies and progressed toward IND-enabling activities. We believe these efforts position the Company well as we move through 2026, while remaining disciplined in our use of capital and focused on creating long-term shareholder value."

Xenetic continues to advance its DNase-based technology toward Phase 1 clinical development for the treatment of pancreatic carcinoma and other locally advanced or metastatic solid tumors. During 2025, the Company completed preclinical studies evaluating DNase I in combination with chemotherapy, immunotherapies and CAR-T approaches across both solid and hematologic cancer models. Data generated from these studies are informing ongoing translational work and manufacturing activities as the Company progresses toward U.S. IND submission.

Summary of Financial Results for Fiscal Year 2025
Net loss for the year ended December 31, 2025 was approximately $2.7 million, reflecting investment in the Company’s most promising scientific programs. Royalty revenue from the Company’s sublicense with Takeda Pharmaceuticals Co. Ltd increased approximately 19% to $3.0 million in the year ended December 31, 2025 from $2.5 million for the year ended December 31, 2024 primarily due to royalty payments received from certain countries. Research and development expenses for the year ended December 31, 2025 decreased by approximately $0.2 million, or 7%, to $3.1 million from $3.3 million in the prior year period. Research and development costs for the year ended December 31, 2024 included a $0.7 million impairment charge that did not reoccur in 2025. This decrease was substantially offset by increased spending in connection with the Company’s DNase process development efforts. General and administrative expenses for the year ended December 31, 2025 were $2.7 million, decreasing by approximately $0.7 million, or 20%, compared to the prior year. This decrease was primarily due to certain severance and benefits expensed during the year ended December 31, 2024 in connection with a separation agreement entered into during the second quarter of 2024 with our former Chief Executive Officer.

The Company ended the year with approximately $7.9 million of cash, representing an increase of approximately $1.7 million compared to the prior year-end, primarily due to net proceeds of approximately $4.0 million from an underwritten public offering completed in October 2025.

(Press release, Xenetic Biosciences, MAR 13, 2026, View Source [SID1234663539])

Purple Biotech Reports Fourth Quarter and Full Year 2025 Financial Results

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.

"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])

bioAffinity Technologies Announces Record 2025 Revenue and Unit Sales for Flagship Lung Cancer Diagnostic CyPath® Lung

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.

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])

AC Immune Reports Full Year 2025 Financial Results and Provides a Corporate Update

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

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

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

Full Year 2025 and Subsequent Highlights:

ACI-7104 anti-α-synuclein active immunotherapy

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

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

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

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

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

Anticipated 2026 Milestones

Program

Milestone

Expected in

ACI-7104
anti-α-synuclein active immunotherapy

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

H2 2026

ACI-24
anti-Abeta active immunotherapy

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

H1 2026

ACI-19764
NLRP3 inhibitor

Results from Phase 1 trial in healthy volunteers

H2 2026

Morphomer-Tau aggregation inhibitors

Lead declaration and initiation of IND-enabling studies

H1 2026

Morphomer α-synuclein aggregation inhibitor

Lead declaration

H1 2026

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

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

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

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