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

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

bioAffinity Technologies expects up to 20 clinical study sites, including a dozen Department of Veterans Affairs (VA) medical centers and two of the nation’s largest military hospitals, will participate in the study. Michael J. Morris, MD, pulmonology and critical care physician at Brooke Army Medical Center, is the national Principal Investigator for the study (NCT07168993). The John P. Murtha Cancer Center Research Program (MCCRP), a research program within the Department of Surgery at the Uniformed Services University of the Health Sciences in Bethesda, Maryland, is providing support and funding associated with the trial at several federal facilities.

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

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

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

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

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

About CyPath Lung

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

(Press release, BioAffinity Technologies, MAR 10, 2026, View Source [SID1234663409])

On March 10, 2026 Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, reported that the United States Patent and Trademark Office (USPTO) has granted a patent covering Alligator’s proprietary bispecific antibody format. The granted patent provides protection for the structural design of tetravalent bispecific antibodies capable of dual antigen binding.

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The patent covers a versatile antibody architecture designed to enable stable and efficient assembly of bispecific antibodies, including configurations targeting immune modulators and tumor-associated antigens. This platform is intended to support the development of next-generation immunotherapies across a range of oncology indications and combination strategies.

The bispecific antibody format covered by the patent underpins multiple programs within Alligator’s research platform and has already demonstrated external validation. In September 2025, Alligator entered into an evaluation and option agreement covering the RUBY antibody format, highlighting the commercial and strategic interest in Alligator’s antibody engineering capabilities.

"This patent grant strengthens the intellectual property foundation around our bispecific antibody platform and highlights the value of our technology beyond mitazalimab," said Søren Bregenholt, CEO of Alligator Bioscience. "It supports our strategy to build long-term value through our innovative antibody formats, both within our own pipeline and through partnerships, as exemplified by the RUBY agreement."

(Press release, Alligator Bioscience, MAR 10, 2026, View Source [SID1234663408])

On March 10, 2026 Alkermes plc (Nasdaq: ALKS) reported that management will participate in a fireside chat at the Stifel 2026 Virtual CNS Forum on Tuesday, March 17, 2026 at 8:30 a.m. ET (12:30 p.m. GMT). The live webcast may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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(Press release, Alkermes, MAR 10, 2026, View Source [SID1234663407])

On March 10, 2026 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), reported financial results for the fourth quarter and full year ended December 31, 2025, and provided recent operational updates.

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"Building off the meaningful progress achieved across our ZYNLONTA clinical program in DLBCL and through investigator-initiated trials in indolent lymphomas this past year, we believe we have laid the foundation for multiple anticipated value-creating catalysts," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "We expect topline LOTIS-5 results in the second quarter, followed by full LOTIS-5 and LOTIS-7 results in 2L+ DLBCL by the end of 2026 and, assuming positive data, potential compendia inclusions in first half of 2027 with LOTIS-5 regulatory approval to follow. Supported by an expected cash runway at least into 2028, we are confident we will drive significant potential long-term growth beginning in 2027."

Fourth Quarter 2025 Operational Updates and Upcoming Milestones

LOTIS-5 topline results anticipated in 2Q 2026. The Company expects to provide topline data in 2Q 2026 from the LOTIS-5 Phase 3 confirmatory trial of ZYNLONTA (loncastuximab tesirine-lpyl) in combination with rituximab in patients with 2L+ diffuse large B-cell lymphoma (DLBCL) once the pre-specified number of approximately 262 progression-free survival events is reached and data are available. Full results are anticipated to be published by the end of 2026. Assuming positive results, the Company will file a supplemental Biologics License Application (sBLA) submission with the U.S. Food and Drug Administration (FDA), with potential compendia inclusion in the first half of 2027 and confirmatory approval in 2L+ DLBCL to follow in mid-2027.

LOTIS-7 trial ongoing with data anticipated by year-end. In December 2025, the Company reported updated data from the LOTIS-7 Phase 1b trial evaluating ZYNLONTA in combination with the bispecific antibody glofitamab (COLUMVI) in patients with relapsed or refractory (r/r) DLBCL. The data demonstrated an 89.8% best overall response rate and a 77.6% complete response rate across 49 efficacy evaluable patients with a minimum of six months follow-up. The LOTIS-7 trial is ongoing at the selected 150 µg/kg dose and the Company plans to share full data at a medical meeting and through publication by the end of 2026. The Company plans to assess regulatory and compendia strategies.

Ongoing investigator-Initiated trials (IITs) evaluating ZYNLONTA in additional B-cell malignancies. The Company anticipates publication of data from the University of Miami Sylvester Comprehensive Cancer Center-led multi-center trials of ZYNLONTA in combination with rituximab to treat r/r follicular lymphoma (FL) and as a monotherapy to treat marginal zone lymphoma (MZL) between the end of 2026 and mid-2027. Assuming positive data, the Company intends to assess potential regulatory and compendia pathways.

Fourth Quarter and Full Year 2025 Financial Results

Product Revenues: Net product revenues were $22.3 million and $73.6 million for the fourth quarter and full year ended December 31, 2025, as compared to $16.4 million and $69.3 million for the same periods in 2024. The quarter-over-quarter increase in revenue primarily reflected variability in customer ordering, with underlying demand broadly stable. The increase for the full year was driven by higher selling price and relatively flat volume year-over-year.

Research and Development (R&D) Expense: R&D expense was $18.2 million and $104.0 million for the fourth quarter and full year ended December 31, 2025, respectively. This compares to R&D expense of $27.1 million and $109.6 million for the same periods in 2024. The decrease in R&D costs quarter-over quarter was primarily driven by a reduction in spending on discontinued programs and completion of the IND-enabling activities for our PSMA-targeting ADC. The decrease in R&D costs for the full year was driven by a reduction in spending on discontinued programs, partially offset by expenditure associated with completion of the IND-enabling activities for our PSMA-targeting ADC and our ongoing ZYNLONTA clinical trials.

Selling and Marketing (S&M) Expense: S&M expense was $12.0 million and $43.4 million for the fourth quarter and full year ended December 31, 2025, respectively. This compares to S&M expense of $11.3 million and $44.0 million for the same periods in 2024. S&M expense remained relatively flat period-over-period.

General & Administrative (G&A) Expense: G&A expense was $9.5 million and $36.6 million for the fourth quarter and full year ended December 31, 2025, respectively. This compares to G&A expense of $9.6 million and $41.9 million for the same periods in 2024. G&A expense remained relatively flat quarter-over-quarter. The reduction in G&A expense for the full year was primarily due to lower external professional fees.

Restructuring, impairment and other related costs: In connection with the strategic reprioritization and restructuring plan announced in June 2025, the Company incurred $0.3 million in income for the fourth quarter and $13.1 million in restructuring, impairment and other related costs for the full year ended December 31, 2025, which consisted of $6.0 million in employee severance and related benefit costs, $5.8 million in non-cash impairment of assets and $1.3 million in dilapidations, lease termination, legal fees, and other related costs in connection with the closure of the UK facility.

Total operating expenses and adjusted total operating expenses: Total operating expenses were $41.0 million and $202.9 million for the fourth quarter and full year ended December 31, 2025, respectively, as compared to $49.3 million and $201.5 million for the fourth quarter and full year ended December 31, 2025, respectively. On a non-GAAP basis, total adjusted operating expenses were $39.4 million and $181.3 million for the quarter and full year ended December 31, 2025, respectively, as compared to $46.6 million and $193.8 million for the quarter and full year ended December 31, 2024, respectively. The reduction in total adjusted operating expenses for the fourth quarter was primarily driven by lower R&D expenses. The decrease in total adjusted operating expenses for the full year was a result of lower R&D, G&A and S&M expenses.

Net Loss: Net loss for the quarter ended December 31, 2025, was $6.4 million, or a net loss of $0.04 per basic and diluted share, as compared to net loss of $30.7 million, or a net loss of $0.29 per basic and diluted share for the same period in 2024. Net loss for the full year ended December 31, 2025, was $142.6 million, or a net loss of $1.12 per basic and diluted share, as compared to net loss of $157.8 million, or a net loss of $1.62 per basic and diluted share for the full year ended December 31, 2024. The lower net loss over both periods was primarily due to a higher cumulative catch-up adjustment gain associated with our deferred royalty obligation and reduced R&D expense, partially offset by the restructuring, impairment and related costs incurred in connection with the strategic reprioritization and restructuring plan.

Adjusted Net Loss: Adjusted net loss, which is a non-GAAP financial measure, was $13.5 million, or an adjusted net loss of $0.09 per basic and diluted share for the quarter ended December 31, 2025, as compared to an adjusted net loss of $26.5 million, or $0.25 per basic and diluted share, for the same period in 2024. Adjusted net loss for the full year ended December 31, 2025, was $91.7 million, or an adjusted net loss of $0.72 per basic and diluted share, as compared to net loss of $111.4 million, or an adjusted net loss of $1.15 per basic and diluted share for the full year ended December 31, 2024. The decrease in adjusted net loss over both periods was due to lower operating expenses and a higher number of weighted average shares outstanding.

Cash and cash equivalents: As of December 31, 2025, cash and cash equivalents were $261.3 million, compared to $250.9 million as of December 31, 2024, providing expected cash runway at least into 2028. The Company significantly strengthened its cash and cash equivalents position by entering into a $100 million PIPE financing in June 2025 and a $60.0 million PIPE financing in October 2025 with certain institutional investors, which raised $150.8 million in total after deducting placement agent fees and offering expenses.

Subsequent event

Amended HealthCare Royalty Financing Agreement.

In February 2026, ADC Therapeutics entered into an amendment to its royalty purchase agreement with entities managed by HealthCare Royalty, offering greater strategic flexibility to the Company. The new agreement reduces the change of control payment from $750 million to $150 million through the end of 2027, and to $200 million thereafter. In the event of a change of control, HealthCare Royalty will continue to receive royalties on sales by the acquirer until the original royalty cap is reached. In return, HealthCare Royalty has been granted warrants to purchase approximately 9.8 million common shares, with an exercise price of $3.81 per share. These warrants are exercisable until December 31, 2030, and are subject to a lock-up through the end of 2027.

Conference Call Details

ADC Therapeutics management will host a conference call and live audio webcast to discuss fourth quarter and full year 2025 financial results and provide a company update today at 8:30 a.m. EDT. To access the conference call, please register here. Registrants will receive the dial-in number and unique PIN. It is recommended that you join 10 minutes before the event, though you may pre-register at any time. A live webcast of the call will be available under "Events & Presentations" in the Investors section of the ADC Therapeutics website at ir.adctherapeutics.com. The archived webcast will be available for 30 days following the call.

(Press release, ADC Therapeutics, MAR 10, 2026, View Source [SID1234663406])

On March 10, 2026 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, reported that the Phase III AMPLIFY trial (NCT06970847) has now consented in excess of the planned number of participants following strong demand for study participation at sites in the United States (US) and Australia. Consenting of new patients has stopped at all sites pending completion of remaining screening assessments and confirmation of final enrolment numbers.

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AMPLIFY (64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants with Biochemical Recurrence of Prostate Cancer) is a non-randomised, single-arm, open-label, multi-centre, diagnostic clinical trial of 64Cu-SAR-bisPSMA positron emission tomography (PET) in participants with rising or detectable prostate-specific antigen (PSA) after initial definitive treatment at clinical sites across the US and Australia.

The aim of this registrational study is to investigate the diagnostic ability of 64Cu-SAR-bisPSMA PET/computed tomography (CT) to detect recurrence of prostate cancer in men with PSA levels above 0.2 ng/mL. Evaluation will be across two imaging timepoints: Day 1 (1-4 hours post-administration, same-day imaging) and Day 2 (approximately 24 hours post administration, next-day imaging).

AMPLIFY commenced in May 2025, seeking to enrol approximately 220 participants, and the first trial participant was imaged in the same month at XCancer with Dr Luke Nordquist (Omaha, NE). The data from this study will complement the Phase I/II COBRA2 and Phase II Co-PSMA3 trials. Both studies have demonstrated enhanced imaging capabilities of 64Cu-SAR-bisPSMA over standard-of-care (SOC) prostate-specific membrane antigen (PSMA) PET imaging in patients with biochemical recurrence (BCR) of prostate cancer. As a pivotal trial, the final study results from AMPLIFY are intended to provide evidence to support an application to the US Food and Drug Administration (FDA) for approval of 64Cu-SAR-bisPSMA as a new diagnostic imaging agent in BCR of prostate cancer.

64Cu-SAR-bisPSMA is also currently being evaluated in another registrational Phase III trial, CLARIFY (NCT06056830)4, which is expected to close recruitment in CY2026. Building on the Phase I PROPELLER5 study, the objective of CLARIFY is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET across same-day and next-day imaging in detecting prostate cancer within the pelvic lymph nodes in patients who are scheduled to undergo radical prostatectomy and pelvic lymph node dissection. The CLARIFY results are intended to support an FDA approval application for 64Cu-SAR-bisPSMA in prostate cancer patients who are candidates for definitive therapy.

Dr Alan Taylor, Executive Chairperson of Clarity Pharmaceuticals, commented, "We are about to enter the realm of a select few Australian companies who have developed a drug at the benchtop of Australian science and completed an international Phase III clinical trial with that drug, taking us one step closer to commercialisation. Our team is excited to have reached this initial recruitment milestone in the AMPLIFY trial in just 9 months since we imaged our first participant in the study. This is no small feat, given we achieved this phenomenal pace of recruitment despite three SOC products already in the market, commercialised by four different companies.

"True to our commitment to the highest standards of clinical research, we recruited participants at numerous different sites across the US and Australia to ensure the trial reflected the broad patient population, real-world clinical settings and various PET cameras in which this product is intended to be used. This strategy required careful planning to allow for all participating sites to contribute to the recruitment, based on allocation of participant numbers to be enrolled per site, resulting in what we believe will be a robust and well-balanced dataset and supporting the integrity and quality of the AMPLIFY study.

"Despite the variations in the sites’ activation times, the speed of enrolment in this trial not only highlights the unmet need in the BCR space but also indicates the strong demand for 64Cu-SAR-bisPSMA from clinicians and patients seeking more effective and accurate prostate cancer detection diagnostics. With persistent outreach from participating sites to enrol more patients, clinicians and patients would rather use an unapproved product, undertaking additional demands of a clinical trial, than rely on the findings of the current SOC PSMA PET.

"To date, we have imaged approximately 600 patients with prostate cancer with 64Cu-SAR-bisPSMA, and just in the last year we scanned over 350 of them. The growing demand for better imaging is driven by so many men around the world with prostate cancer who seek accurate and timely identification of disease location and recurrence. We are committed to answering these needs of patients, clinicians and imaging facilities with a next-generation diagnostic imaging agent specifically designed to deliver significant benefits in efficacy, clinical management, quality of life and operational flexibility across the prostate cancer care pathway.

"The results on 64Cu-SAR-bisPSMA generated to date, from our initial discovery and pre-clinical work, to the recently announced Co-PSMA and the COBRA trials, constitute an extensive body of evidence against SOC, demonstrating that maximal clinical benefit of PSMA PET can be derived through the combination of the proprietary SAR-bisPSMA agent and optimised imaging timepoints facilitated by the half-life of copper-64. Achieving a two to three times improvement in lesion detection over SOC in BCR is an incredible achievement. We believe we can grow the blockbuster PSMA PET market even further with a product that has shown impressive efficacy in clinical trials coupled with many logistical and supply chain benefits. Our team will be working closely with our vendors and participating sites to advance the final data package and with regulatory authorities to get this product to patients in need as soon as possible.

"We also look forward to closing recruitment in the CLARIFY trial this year and progressing our theranostic Phase I/IIa SECuRE trial towards completion. Together with three Fast Track Designations we have for SAR-bisPSMA and positive interactions with the US FDA to date, these milestones place us closer than ever to commercialisation of this exciting agent through the entirety of the prostate cancer journey, from first detection to late-stage metastatic disease."

About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death in men worldwide6. Prostate cancer is the second-leading cause of cancer death in American men. The American Cancer Institute estimates there will be about 333,830 new cases of prostate cancer in the US in 2026 and around 36,320 deaths from the disease.

(Press release, Clarity Pharmaceuticals, MAR 10, 2026, View Source [SID1234663360])