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

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!

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

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

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

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

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

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

On March 10, 2026 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.

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!

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.

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!

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.

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!

(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.

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!

"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])