On January 12, 2026 Bristol-Myers Squibb presented its corporate presentation.

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(Presentation, Bristol-Myers Squibb, JAN 12, 2026, View Source [SID1234661941])

On January 12, 2026 BioNTech SE (Nasdaq: BNTX, "BioNTech") and OncoC4, Inc. ("OncoC4") reported that the U.S. Food and Drug Administration ("FDA") has granted Orphan Drug Designation to gotistobart (also known as BNT316 or ONC-392) for the treatment of squamous NSCLC, an aggressive subtype of lung cancer with limited therapeutic options in the advanced stage. The FDA grants Orphan Drug Designation to potential new medicines for prevention, diagnosis, or treatment of patients with either a rare disease, or a specific patient population with a non-rare disease. This designation underscores the urgent medical need for new therapeutic options for patients living with this condition.

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Gotistobart is a novel tumor microenvironment-selective regulatory T cell ("Treg") depletion candidate targeting CTLA-4. With its unique mode of action, gotistobart has the potential to address the high unmet medical need in patients with squamous NSCLC, which accounts for around 25% of all lung cancer cases1 and high disease-related mortality2. Squamous NSCLC is a devastating disease with a 5-year relative survival rate of 15%, a median survival time of 11 months in the United States (2000-2017)3, and with limited treatment options in the advanced stage. For advanced or metastatic squamous NSCLC patients, the treatment options for second-line therapy after first-line immunotherapy and chemotherapy are usually limited to chemotherapy or palliative therapy.4

The pivotal Phase 3 clinical trial PRESERVE-003 (NCT05671510; EUCT:2023-505311-20-01) is ongoing, evaluating gotistobart in patients with metastatic squamous NSCLC at 160 sites globally. In a data readout from the non-pivotal dose-confirmation stage of the trial, gotistobart demonstrated a clinically meaningful overall survival ("OS") benefit, compared to standard-of-care chemotherapy and a manageable safety profile in squamous NSCLC patients whose disease had progressed following anti-PD-(L)1 therapy and platinum-based chemotherapy. These data were previously announced and presented in an oral presentation at the IASLC ASCO (Free ASCO Whitepaper) 2025 North America Conference on Lung Cancer. In addition to the recently granted Orphan Drug Designation, the FDA granted Fast Track Designation to gotistobart in 2022 for the treatment of patients with metastatic NSCLC whose disease progressed on prior anti-PD-(L)1 therapy.

About gotistobart (BNT316/ONC-392)
Gotistobart (BNT316/ONC-392) is a tumor microenvironment-selective Treg depletion candidate developed jointly by BioNTech and OncoC4. As a pH-sensitive monoclonal antibody, gotistobart is designed to enable CTLA-4 protein recycling. After binding to the CTLA-4 receptor on the cell surface, the complex is internalized, and the pH change causes the antibody to unbind, allowing CTLA-4 to return to the surface to preserve the immune checkpoint function at peripheral organs and to enhance anti-tumor immunity in the tumor microenvironment5. Gotistobart is currently in late-stage clinical development as monotherapy and as a component of combination therapy in various cancer indications. Gotistobart received Fast Track Designation from the U.S. Food and Drug Administration ("FDA") in 2022 for the treatment of patients with metastatic NSCLC whose disease progressed on prior anti-PD-(L)1 therapy and Breakthrough Therapy Designation from China’s National Medical Products Administration ("NMPA") in 2025.

About PRESERVE-003 Trial
PRESERVE-003 (NCT05671510; EUCT:2023-505311-20-01) is a two-stage, open-label Phase 3 trial evaluating the efficacy and safety of gotistobart as monotherapy compared to the standard-of-care chemotherapy (docetaxel) in sqNSCLC patients, who have progressed on PD-(L)1 inhibitors and platinum-based chemotherapy. The non-pivotal stage of the trial originally included all NSCLC patients. The ongoing pivotal stage is currently enrolling patients with squamous NSCLC. During the ongoing pivotal stage, patients are planned to be enrolled at 160 clinical sites in various countries and regions, including Australia, Belgium, Canada, China, Germany, Italy, the Netherlands, Spain, South Korea, Türkiye, the United Kingdom and the United States. The primary endpoint is overall survival. Secondary endpoints include overall response rate, progression-free survival and safety profile.

(Press release, BioNTech, JAN 12, 2026, View Source [SID1234661940])

On January 12, 2026 Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported 2025 accomplishments and strategic priorities for 2026.

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"In 2025, we remained steadfast in our goal of helping patients live longer and live well, making meaningful advancements to our pipeline and strengthening the operational capabilities that support our strategic priorities. In addition to the progress we continue to make with zelenectide pevedotin and BT5528, our recently announced collaborations with the United Kingdom Nuclear Decommissioning Authority, United Kingdom National Nuclear Laboratory and SpectronRx provide us with the potential for an end-to-end supply chain for 212Pb, building on the existing supply chains we have established for 177Lu and 68Ga. In summary, by combining these supply collaborations with our proprietary Bicycle technology we have established a unique radiopharmaceutical capability from the identification of Bicycle targeting agents to the potential commercial supply of the radiotherapeutic across multiple radioisotopes," said Bicycle Therapeutics CEO Kevin Lee, Ph.D. "We look forward to providing updates on the potential approval pathway for zelenectide pevedotin and dose selection from the Phase 2/3 Durvelo-2 trial in the first quarter of 2026."

2025 Key Accomplishments

Reported updated topline Phase 1 Duravelo-1 combination data for zelenectide pevedotin plus pembrolizumab in first-line cisplatin-ineligible patients with metastatic urothelial cancer (mUC). The data continue to show zelenectide pevedotin’s promising anti-tumor activity and differentiated safety profile.
Initiated Phase 1/2 Duravelo-3 trial for zelenectide pevedotin in NECTIN4-amplified breast cancer.
Initiated Phase 1/2 Duravelo-4 trial for zelenectide pevedotin in NECTIN4-amplified non-small cell lung cancer.
Reported first human imaging data for an early Bicycle Radioconjugate (BRC) molecule targeting EphA2 at the Targeted Radiopharmaceuticals Summit Europe. The data supports the potential of EphA2 as a novel cancer target and demonstrates the positive properties of BRC molecules for radiopharmaceutical use.
Presented additional human imaging data for an early Bicycle Radioconjugate (BRC) molecule targeting MT1-MMP at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025. The company believes this data further supports the potential of MT1-MMP as a novel target in the treatment of cancer, demonstrates the translatability of BRC preclinical data and highlights the potential of Bicycle molecules for targeted radionuclide therapies and radiopharmaceutical imaging.
2026 Strategic Priorities and Anticipated Milestones

Nectin-4 Pipeline (zelenectide, BT7480)

Provide an update on dose selection for Phase 2/3 Duravelo-2 pivotal trial and zelenectide pevedotin’s potential approval pathway in mUC following meetings with multiple regulatory agencies in the first quarter of 2026.
Report dose selection data from Phase 2/3 Duravelo-2 pivotal trial evaluating zelenectide pevedotin in combination with pembrolizumab in patients with mUC at a scientific conference in the first half of 2026.
Report additional Phase 1 Duravelo-1 combination data with pembrolizumab in first-line cisplatin-ineligible mUC at a scientific conference in the first half of 2026.
Report longer-term follow-up Phase 1 Duravelo-1 monotherapy data in late-line mUC at a scientific conference in the first half of 2026.
Report initial data for Phase 1/2 Duravelo-3 trial for zelenectide pevedotin in NECTIN4-amplified breast cancer at a scientific conference in the second half of 2026.
Report Phase 1 BT7480 combination data with nivolumab at a scientific conference in the first half of 2026.
EphA2 Pipeline (BT5528, EphA2 imaging)

Report Phase 1 BT5528 combination data with nivolumab in mUC patients at a scientific conference in the first half of 2026.
Provide an update on future clinical development plans for BT5528 in the first half of 2026.
Report additional EphA2 human imaging data in the first half of 2026.

(Press release, Bicycle Therapeutics, JAN 12, 2026, View Source [SID1234661939])

On January 12, 2026 Autolus Therapeutics plc (Nasdaq: AUTL), a commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, reported preliminary unaudited net product revenue from sales of AUCATZYL (obecabtagene autoleucel; obe-cel) for the fourth quarter and full year of 2025. The Company also announced pipeline advancement updates and anticipated future milestones.

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AUCATZYL 2025 Preliminary Unaudited Net Product Revenues, Commercial Updates and 2026 Revenue Guidance

Dr. Christian Itin, Chief Executive Officer of Autolus, said: "We had a successful launch of AUCATZYL in the US with full year sales well above expectations and more than 60 centers offering treatment. We established reliable, high-quality product delivery with short and consistent turn-around time. Parallel to the launch and independent from the Company, the ROCCA consortium collected real-world data for AUCATZYL in adult r/r B-ALL patients and presented initial data at ASH (Free ASH Whitepaper) 2025. The real-world data confirmed a high level of clinical activity and a favorable safety profile for AUCATZYL consistent with prior clinical trial results, and we believe this positive customer experience will be a key driver for the future growth of AUCATZYL in 2026.

"In addition to our launch of AUCATZYL in the US, we obtained regulatory approvals in the UK and EU. We successfully navigated the challenging pricing and reimbursement process with NICE, establishing cost effectiveness of AUCATZYL for the NHS and initiating our commercial launch in the UK in December under routine commissioning – a first for a CAR T therapy in the UK."

Based on preliminary unaudited financial information, Autolus expects net product revenue from sales of AUCATZYL to be approximately $24 million1 for the fourth quarter of 2025. Net product revenues for the full year of 2025, the first year of commercial sales, are expected to be approximately $75 million1. The Company plans to report its fourth quarter and full year 2025 financial results in March 2026.

For 2026, the Company projects net product revenue for AUCATZYL of between $120 million to $135 million.

Pipeline Updates and Upcoming Clinical Milestones

Dr. Matthias Will, Chief Development Officer of Autolus, said: "In 2025 we reported strong initial clinical data for the Phase 1 CATULUS trial in pediatric r/r B-ALL patients and in the Phase 1 CARLYSLE trial in patients with severe lupus erythematosus. Both data sets form a compelling basis for progressing those studies in pediatric B-ALL and in lupus nephritis to Phase 2. With this strong foundation of clinical data, Phase 2 studies enrolling and demonstrated commercial and manufacturing capabilities, we believe Autolus is well positioned to drive growth with obe-cel in additional and significant indications."

Obe-cel data in pediatric r/r B-ALL

Preliminary data from the CATULUS Phase 1 trial of obe-cel in pediatric relapsed or refractory (r/r) B-ALL patients were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. Obe-cel demonstrated high remission rates in pediatric patients with high-risk r/r B-ALL with overall response rate (ORR) of 95.5%. Low rates of high-grade cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were observed, consistent with obe-cel’s adult safety profile. Autolus is now advancing obe-cel into the Phase 2 portion of the trial and expects to have the trial fully enrolled in the first half of 2027.
Obe-cel in lupus nephritis (LN)

Data from the ongoing Phase 1 CARLYSLE trial in patients with severe refractory systemic lupus erythematosus (srSLE) were reported at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. All patients show deep B-cell depletion after infusion, suggesting an immune reset. No ICANS or high-grade CRS were observed in the nine patients evaluable for safety.
Data support progressing obe-cel as a treatment for LN and 50 million cells was selected as the recommended Phase 2 dose. Autolus has previously aligned with the US Food and Drug Administration (FDA) on a Phase 2 trial design in LN and potential registrational path to approval. The LUMINA trial is now enrolling.
Obe-cel in progressive multiple sclerosis (MS)

Autolus is advancing obe-cel into initial clinical development to explore treatment in progressive MS. The first patient in the BOBCAT trial was dosed in October 2025. The Phase 1 trial, expected to include up to 18 adult patients, will determine the safety, tolerability, and preliminary efficacy of obe-cel in participants with refractory progressive forms of MS. Initial data from the trial are expected to be reported at the end of 2026.
AUTO8 in light-chain amyloidosis

The first patient was dosed in the Phase 1 ALARIC trial in AL amyloidosis and initial data is expected to be reported at the end of 2026.
Operational Updates & 2026 Outlook

Dr. Christian Itin concluded: "Our 2026 commercial focus for AUCATZYL is to build on the strong center presence and positive physician experience to drive top line growth, while improving margins by reducing our manufacturing costs per batch. Our development focus is on progressing our pivotal pediatric ALL CATLULUS and lupus nephritis LUMINA studies and the exploratory BOBCAT study in progressive multiple sclerosis. Our plans for innovation will focus on manufacturing technology and European market access."

Increasing patient numbers in 2026 will improve manufacturing plant utilization and together with operational efficiencies, Autolus expects a shift from previously reported negative gross margin to positive gross margin in 2026.

Autolus has initiated an overall manufacturing life cycle plan to facilitate additional cost reductions and gross margin improvements as the Company plans to expand obe-cel into new indications and pursue larger market opportunities. The initiatives are focused on: 1) optimizing the Company’s current manufacturing operating model; 2) enhancing automation opportunities for the Company’s existing manufacturing process; and 3) developing a next-generation manufacturing platform with a step change in the cost and capacity profile. The Company plans to provide a detailed update on these plans in mid-2026.

Based on current operating plans, including anticipated AUCATZYL net revenues, Autolus expects that its current and projected cash, cash equivalents and marketable securities will be sufficient to fund the Company’s operations into Q4 2027.

(Press release, Autolus, JAN 12, 2026, View Source [SID1234661938])

On January 12, 2026 Aim Immunotech presented its corporate presentation.

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(Presentation, AIM ImmunoTech, JAN 12, 2026, View Source [SID1234661937])