On January 12, 2026 Vir Biotechnology, Inc. (Nasdaq: VIR) reported key program updates, including new positive data from the ongoing SOLSTICE Phase 2 trial in chronic hepatitis delta (CHD). Participants receiving the combination therapy of tobevibart, an investigational neutralizing monoclonal antibody (mAb), and elebsiran, an investigational small interfering RNA (siRNA), showed increased and sustained viral suppression of HDV RNA versus treatment with the antibody alone in participants who have reached Week 96 of treatment.

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The Company also announced that safety and efficacy data from the Phase 1 trial of VIR-5500, its PSMA-targeted PRO-XTEN dual-masked T-cell engager (TCE) being evaluated in prostate cancer, will be shared in an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium in February.

"We are poised for a year of significant clinical progress where we will report initial topline data from our Phase 3 program in CHD, present substantive Phase 1 safety and efficacy data from our PSMA-targeted VIR-5500 TCE program and continue to advance our broader portfolio of PRO-XTEN masked TCEs through dose escalation," said Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, Vir Biotechnology. "The latest data from our SOLSTICE Phase 2 trial evaluating tobevibart and elebsiran combination therapy in CHD are very promising, showing that monthly treatment with this combination therapy has the potential to achieve an undetectable viral load in a large number of patients, which could redefine the standard of care in CHD."

Vir Biotechnology will present at the 44ᵗʰ Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026, at 3:45 p.m. PT. The webcast and presentation will be accessible from the Company’s website under Events & Presentations.

Recent Updates and 2026 Clinical Milestones

Tobevibart and elebsiran combination therapy for CHD

Data from the Phase 2 SOLSTICE trial to be presented at the 44ᵗʰ Annual J.P. Morgan Healthcare Conference demonstrate that undetectable hepatitis delta virus RNA (HDV RNA Target Not Detected, TND) was achieved and maintained by 77% (24/31) of participants receiving the combination of tobevibart and elebsiran at Week 72, and this rate increased to 88% (21/24) in the subset of participants evaluated through Week 96. By contrast, HDV RNA TND was achieved by 53% (17/32) of participants receiving tobevibart antibody monotherapy at Week 72 and 46% (11/24) in the subset of participants evaluated through Week 96. There were no grade 3 or higher treatment-related adverse events in the combination arm, and treatment emergent adverse events were generally mild to moderate and transient. Complete results at Week 96 will be presented at a future medical meeting. Previous positive Phase 2 SOLSTICE data at Week 48 were published in the New England Journal of Medicine.2

The registrational ECLIPSE program in CHD is ongoing, with ECLIPSE 1 and ECLIPSE 3 fully enrolled. Topline data from the ECLIPSE 1 trial is expected in the fourth quarter of 2026. Topline data from the ECLIPSE 2 and ECLIPSE 3 trials are expected in the first quarter of 2027.

Last month, Vir Biotechnology granted Norgine Pharma UK Limited, an affiliate of Norgine, an exclusive license for the commercial rights to the combination of tobevibart and elebsiran for the treatment of CHD in Europe, Australia and New Zealand. Vir Biotechnology has retained all commercialization rights for tobevibart and elebsiran in the United States and other markets outside of the Greater China Territory.3

PRO-XTEN dual-masked TCE immunotherapy portfolio

PSMA-targeted PRO-XTEN dual-masked TCE VIR-5500 is currently being evaluated as monotherapy and in combination with androgen receptor pathway inhibitors (ARPIs) for the first-line treatment of metastatic castration-resistant prostate cancer (mCRPC). Vir Biotechnology will share updated Phase 1 data at the 2026 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium in February. The Company previously shared preliminary data from the ongoing trial in January 2025 and will provide an update that includes safety and efficacy data of VIR-5500 monotherapy in the later-line mCRPC patients, including RECIST and PSA responses, durability and dose-response relationship.

Vir Biotechnology is also currently enrolling patients in its Phase 1 dose escalation trials for VIR-5818 in HER2-expressing solid tumors and VIR-5525 in EGFR-expressing solid tumors. Phase 1 dose escalation response data for VIR-5818 are expected in the second half of 2026.

Additionally, the Company is currently progressing a number of PRO-XTEN masked TCEs in preclinical studies directed at clinically validated targets with potential applications across a variety of solid tumors, including lung, colorectal and bladder. All candidates have been discovered and optimized by leveraging Vir Biotechnology’s antibody and TCE discovery and engineering platform, which includes dAIsY (data AI structure and antibodY), a proprietary artificial intelligence engine, and the universal PRO-XTEN masking technology.

2025 ending cash position (unaudited) and runway projection

Cash, cash equivalents and investments were approximately $781 million as of December 31, 2025.1 As a result of the anticipated net cash benefits from the Norgine licensing agreement, and through continued financial discipline, the Company expects cash, cash equivalents and investments to fund operations into the fourth quarter of 2027.

About the ECLIPSE Registrational Program

ECLIPSE is a registrational program to evaluate the safety and efficacy of tobevibart in combination with elebsiran in patients with chronic hepatitis delta (CHD). ECLIPSE includes three randomized, controlled trials designed to evaluate the combination therapy in comparison to deferred treatment or bulevirtide. ECLIPSE 1 (NCT06903338) is a Phase 3 trial evaluating the safety and efficacy of tobevibart in combination with elebsiran compared to deferred treatment in the U.S. or other regions where bulevirtide use is limited. ECLIPSE 2 (NCT07128550) is a Phase 3 trial evaluating the efficacy and safety of switching to tobevibart and elebsiran in people with CHD who have not achieved viral suppression with bulevirtide therapy. ECLIPSE 1 and 2 are designed to provide the registrational efficacy and safety data needed for potential submission to global regulatory agencies. ECLIPSE 3 (NCT07142811) is a Phase 2b head-to-head trial evaluating combination tobevibart and elebsiran compared with bulevirtide in bulevirtide-naïve patients, and it is designed to provide important supportive data to help establish access and reimbursement in key markets.

About Tobevibart and Elebsiran

Tobevibart is an investigational broadly neutralizing monoclonal antibody (mAb) targeting the hepatitis B surface antigen (HBsAg). It is designed to inhibit the entry of hepatitis B and hepatitis delta viruses into hepatocytes and to reduce the level of circulating viral and subviral particles in the blood. Tobevibart was identified using Vir Biotechnology’s proprietary mAb discovery platform. The Fc domain has been engineered to increase immune engagement and clearance of HBsAg immune complexes and incorporates Xencor’s Xtend technology to extend half-life. Tobevibart is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis delta.

Elebsiran is an investigational hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) licensed from Alnylam Pharmaceuticals, Inc. It is designed to degrade hepatitis B virus RNA transcripts and limit the production of HBsAg. Current data indicate that it has the potential to have direct antiviral activity against hepatitis B virus and hepatitis delta virus. Elebsiran is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis delta.

About Chronic Hepatitis Delta (CHD)

CHD is the most severe form of chronic viral hepatitis4 and was recently classified as carcinogenic by the International Agency for Research on Cancer.5 People living with the disease rapidly progress to cirrhosis, liver failure6 and liver-related death.4 There are currently no approved treatments in the U.S., and options are limited in the European Union and globally.

About VIR-5500, VIR-5818, VIR-5525

VIR-5500, VIR-5818 and VIR-5525 are investigational, clinical candidates currently being evaluated for the treatment of solid tumors. These assets leverage the universal PRO-XTEN masking technology and target PSMA, HER2 and EGFR, respectively.

TCEs are powerful anti-tumor agents that can direct the immune system, specifically T-cells, to destroy cancer cells. The universal PRO-XTEN masking technology is designed to keep the TCEs inactive (or masked) until they reach the tumor microenvironment, where tumor-specific proteases cleave off the mask and activate the TCEs, leading to killing of cancer cells. By driving the activity exclusively to the tumor microenvironment, we aim to circumvent the traditionally high toxicity associated with TCEs and increase their efficacy and tolerability. Additionally, the mask is designed to help drug candidates stay in the bloodstream longer in their inactive form, allowing them to better reach the site of action and potentially allowing less frequent dosing regimens for patients and clinicians.

(Press release, Vir Biotechnology, JAN 12, 2026, View Source [SID1234661998])

On January 12, 2026 Kivu Bioscience, a clinical-stage biotechnology company developing next-generation antibody-drug conjugates (ADCs) for difficult-to-treat cancers, reported that the first patient has been dosed in its Phase 1 clinical trial of KIVU-107, a next-generation PTK7-targeting ADC for patients with advanced solid tumors.

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"Dosing the first patient with KIVU-107 marks an important milestone for Kivu and for patients with advanced solid tumors who urgently need better treatment options," said Mohit Trikha, Ph.D., President and Chief Operating Officer, Kivu Bioscience. "Advancing KIVU-107 from preclinical development to first-in-human dosing in under 12 months underscores the efficiency of our platform and our commitment to developing a new generation of ADCs designed to expand the therapeutic window and deliver meaningful benefit to patients."

The first-in-human Phase 1 study (NCT07229313) is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of KIVU-107 in patients with advanced solid malignancies. KIVU-107 is built using GlycoConnect and HydraSpace site-specific conjugation technologies, enabling precise and stable drug-to-antibody ratios and optimized pharmacokinetics to improve the therapeutic window. KIVU-107 is designed to deliver potent, targeted cytotoxic activity in PTK7-expressing tumors while improving safety and tolerability compared to earlier-generation ADCs. The study has received regulatory approval in the United States and Australia.

(Press release, Kivu Bioscience, JAN 12, 2026, View Source [SID1234661997])

On January 12, 2026 Tempus, a leader in artificial intelligence and precision medicine, and NYU Langone Health, one of the nation’s premier academic medical centers, reported a multi-year strategic collaboration aimed at transforming cancer care through advanced molecular profiling and data-driven insights. The collaboration will support NYU Langone Health’s Center for Molecular Oncology at the Laura and Isaac Perlmutter Cancer Center, a comprehensive, pan-cancer initiative to more deeply understand disease biology over time.

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The research seeks to enhance genomic diagnostics to improve patient outcomes, inform future clinical practice, and accelerate the development and validation of novel assays and algorithmic diagnostics. As part of this work, the two organizations are launching a prospective observational study titled, "Serial Molecular Profiling and Monitoring of Human Cancer," in which patients enrolled in the study will be sequenced throughout their treatment journey in an effort to collect the longitudinal data critical to this research. The collaboration, which evolved independently from Tempus’ relationship as a trusted provider of NGS testing services, also includes a series of subsequent studies focused on assay validation, biomarker discovery, biological modeling, real-world data analysis, and the development of AI-powered predictive algorithms.

"Through the integration of advanced genomic technologies and data science, we are deepening our understanding of cancer’s complexity and pioneering transformative approaches for patient monitoring and treatment," said Ezra Cohen, MD, Chief Medical Officer, Oncology at Tempus. "Our research is focused on generating actionable insights through better understanding of cancer response, resistance, and trajectory that will not only refine and enhance current assays, but also drive the creation of innovative diagnostic tools and algorithms that can empower clinicians to deliver truly individualized care to their patients."

"This strategic collaboration will further our ability to analyze cutting-edge serial molecular profiling technology in the routine care of patients at the Perlmutter Cancer Center at NYU Langone Health," said Shridar Ganesan, MD, PhD, Director of the Center for Molecular Oncology at Perlmutter Cancer Center. "This approach will enable us to better understand the biology of individual cancers, inform our ability to implement and develop targeted therapies, and assess response and emerging resistance."

(Press release, Tempus, JAN 12, 2026, View Source [SID1234661996])

On January 12, 2026 Schrödinger, Inc. (Nasdaq: SDGR) reported an update on its progress across the business in 2025 and announced its strategic priorities for 2026. The company is continuing to focus on advancing its physics+AI computational platform and serving as a global leader in computational molecular discovery.

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"In 2025, we witnessed the continued impact of scaling ‘physics+AI’ to solve the challenges of data scarcity and to accelerate the discovery of differentiated molecules. We are entering 2026 with a clear mandate: to further strengthen our position as the essential design engine for the industry," stated Ramy Farid, Ph.D., chief executive officer at Schrödinger. "Our priorities for 2026 are focused on scaling our impact, maintaining scientific leadership, expanding the reach of our platform, advancing our collaborative portfolio of drug discovery programs, and securing development partners for our clinical programs. We are entering 2026 with strong momentum, highlighted by new strategic agreements with Lilly and Manas AI."

Last week, Schrödinger announced that the Lilly TuneLab platform will be integrated into LiveDesign, Schrödinger’s widely used enterprise informatics solution. This allows users to combine Lilly’s federated learning models with Schrödinger’s physics-based simulations, solving the data scarcity problem that often hinders AI-driven discovery.

Today Manas AI announced that it entered into a strategic agreement with Schrödinger that grants Manas AI access to Schrödinger’s computational platform at an ultra-large scale and integrates Schrödinger’s physics-based modeling solutions with Manas AI’s algorithms to improve predictive accuracy and speed.

2025 Achievements

Today Schrödinger highlighted several 2025 achievements, including the following:

Computational Platform

Advanced its predictive toxicology initiative and made the beta version available to customers, which encompasses approximately 50 representative kinases in addition to multiple key anti-targets.
Launched a new AI-powered conversational interface in Schrödinger’s graphical interface, Maestro, providing context-aware help and enabling natural language commands for manipulation of the 3D workspace.
Published 20 peer-reviewed articles in life sciences and materials science journals, including research describing computational approaches to achieve kinome-wide selectivity in drug discovery campaigns, using the discovery of selective Wee1 kinase inhibitors as a case study, and research describing the development of an advanced Machine Learning Force Field (MPNICE) for liquid and materials properties.
Collaborative Portfolio and Co-Founded Companies

Expanded its research collaboration with Ajax Therapeutics, a company co-founded by Schrödinger. The expansion added a new Janus kinase (JAK) target to the collaboration. Also in 2025, Ajax reported positive preclinical data for AJ1-11095, a first-in-class Type II JAK2 inhibitor and that was granted FDA orphan drug designation for the treatment of myelofibrosis.
Expanded its research agreements with both Lilly and Otsuka Pharmaceutical Co., Ltd., adding additional undisclosed targets to the existing collaborations.
Takeda announced positive topline results for the two pivotal Phase 3 randomized, multicenter, double-blind, placebo- and active comparator-controlled studies of zasocitinib, a next-generation, highly selective oral TYK2 inhibitor, in adults with moderate-to-severe plaque psoriasis. Takeda acquired zasocitinib in 2023 from Nimbus, a company co-founded by Schrödinger. Zascocitinib was co-invented by Schrödinger and Nimbus by applying Schrödinger’s platform at scale and is one of the most advanced molecules in clinical development discovered using a predict-first paradigm.
Structure Therapeutics, a company co-founded by Schrödinger, announced the initiation of a first-in-human Phase 1 clinical study of ACCG-2671, an oral small molecule amylin receptor agonist for the treatment of obesity.
Copernic Catalysts announced the creation of a new, more efficient, ammonia synthesis catalyst. This new chemistry reduces energy consumption used in ammonia production by up to 47%, representing substantial cost savings and environmental benefits for industrial producers.
Proprietary Therapeutics Portfolio

Presented encouraging initial Phase 1 clinical data for SGR-1505, the company’s MALT1 inhibitor in patients with relapsed/refractory B-cell malignancies, at three medical conferences. SGR-1505 has been observed to have a favorable safety profile and demonstrated clinical activity, with responses observed in multiple histologies, including in patients with chronic lymphocytic leukemia (CLL) and Waldenström macroglobulinemia (WM). Additionally, SGR-1505 received Fast Track Designation from the FDA for the treatment of adult patients with WM that have failed at least two lines of therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor, as well as Orphan Drug Designation for the treatment of WM.
Advanced the Phase 1 study of SGR-3515, the company’s Wee1/Myt1 co-inhibitor, in patients with advanced solid tumors.
Progressed its portfolio of proprietary preclinical programs, including presenting data for SGR-5573, the company’s potent, selective, brain-penetrant inhibitor of osimertinib-resistant EGFR variants, presenting data for SGR-4174, the company’s SOS1 inhibitor, and selecting SGR-6016, a brain-penetrant NLRP3 inhibitor development candidate.
Advanced its portfolio of discovery-stage programs, including programs with first-in-class and best-in-class potential in the areas of inflammation and immunology, neurology and oncology.
2026 Strategic Priorities

Today, Schrödinger outlined the following priorities to drive growth and innovation:

Platform Scaling and Evolution

Drive increased customer adoption of its computational technology and enterprise informatics platform
Complete beta testing for the Predictive Toxicology solution
Expand its offering into new customer segments, including biologics, formulation, and synthetic chemistry
Therapeutics Portfolio Execution

Complete the Phase 1 data packages for SGR-1505 and SGR-3515
Present initial data from the Phase 1 study of SGR-3515 in patients with advanced solid tumors in the first half of 2026
Explore strategic partnerships for the SGR-1505 and SGR-3515 programs to advance the development of these programs
Advance collaborative and proprietary discovery programs

(Press release, Schrodinger, JAN 12, 2026, View Source [SID1234661995])

On January 12, 2026 OSR Holdings, Inc. (NASDAQ: OSRH) reported that its Swiss biotechnology subsidiary, Vaximm AG, has received a binding term sheet from BCM Europe AG confirming BCM Europe’s interest in entering a global exclusive licensing transaction for VXM01, Vaximm’s lead immunotherapy candidate.

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Under the terms of the binding term sheet, BCM Europe intends to establish and manage a dedicated investment vehicle, anchored by a strategic investor, tentatively named BCM Decentralized Science Investors I, LP (the "Fund"), which would act as the Licensee under the contemplated definitive license agreement. The proposed transaction structure includes:

the grant of global exclusive rights to develop and commercialize VXM01 to the Fund;
an upfront payment of $30 million, an increase from the previously discussed non-binding proposal, structured as 50% cash and 50% digital assets;
aggregate milestone payments of up to $815 million, with the milestone structure weighted primarily toward clinical and development achievements, rather than operational milestones; and
a royalty pass-through structure, pursuant to which the Fund would pass through royalty revenues received from a future sublicensee or commercial partner (the "Ultimate Licensee") to Vaximm, subject to a reconciliation mechanism reflecting the difference, if any, between milestone payments received from the Ultimate Licensee and the aggregate milestone payments paid by the Fund to Vaximm.
Vaximm’s Board of Directors will conduct a comprehensive review of the binding term sheet and has determined to engage an independent third-party valuation firm with recognized expertise in life-science and biotechnology licensing transactions to provide a fairness opinion. The fairness opinion will evaluate whether the proposed transaction is fair and reasonable to Vaximm and OSR Holdings’ shareholders from a financial point of view, based on the fair market value of VXM01.

"VXM01 has demonstrated encouraging clinical and safety data across multiple indications. The receipt of this binding term sheet reflects the growing recognition of VXM01’s potential value as a differentiated immunotherapy asset and underscores BCM Europe’s genuine intent and capability to close the deal," said Andreas Niethammer, CEO of Vaximm AG. "If completed, this proposed licensing framework would provide a strong foundation to advance VXM01 into later-stage development while preserving long-term upside for Vaximm."

The parties currently target, on a best-efforts basis, to negotiate and execute a definitive global exclusive license agreement by the end of May 2026, subject to customary conditions, including the completion of Vaximm’s board review, receipt of an independent third-party fairness opinion, final documentation, and required approvals.

"This binding term sheet represents a meaningful progression from earlier discussions and reflects third-party confidence in the value of VXM01," said Tim Smith, Head of Investor Relations at OSR Holdings. "While we remain mindful that a definitive agreement has not yet been executed, we believe the proposed structure, together with an independent valuation review, demonstrates a disciplined approach to unlocking long-term value for OSR Holdings’ shareholders."

(Press release, Vaximm, JAN 12, 2026, View Source [SID1234661994])