Recent developments highlight regulatory progress and clinical advancements for NovaBridge's key drug candidates, along with financial and operational updates.

• NovaBridge won FDA Fast Track status for givastomig in first-line gastric cancer, enhancing regulatory pathway prospects [N1].
• The FDA also granted Fast Track designation to givastomig combination therapy for advanced gastric cancer [N2].
• The company plans a Phase 2b clinical program for VIS-101 in wet age-related macular degeneration in the second half of 2026; fiscal year 2025 net loss widened [N3].
• NovaBridge secured FDA alignment on an accelerated approval pathway for givastomig in gastric cancer [N4].
• Positive topline results were reported from a Phase 2a study of VIS-101 [N5].
• The first patient was dosed in a Phase 2 study of givastomig in gastric cancer, with data anticipated in 2027 [N6].
• Positive Phase 1b results were reported for givastomig in metastatic gastric cancer [N7].
• Promising Phase 1 results were announced for ragistomig, a 4-1BB x PD-L1 bispecific antibody [N8].

The company has achieved multiple regulatory milestones including FDA Fast Track designations for givastomig in gastric cancer, indicating regulatory recognition of its therapeutic potential. Positive clinical data from Phase 1b and Phase 2a studies for givastomig and VIS-101 demonstrate progress in its pipeline. Strategic partnerships, such as the collaboration with AbbVie, provide financial resources and development expertise. Strong liquidity and cash reserves support ongoing clinical programs and operational needs. The planned Phase 2b program for VIS-101 and ongoing Phase 2 studies for givastomig represent key steps in clinical advancement.

NovaBridge faces risks typical of clinical-stage biotechnology companies, including the inherent uncertainties of clinical trial outcomes, regulatory approvals, and market acceptance. The company reported widening net losses, reflecting high R&D expenses without significant product revenues. Dependence on milestone payments and collaborations may introduce variability in revenue streams. Changes in regulatory environments, competition from other innovative therapies, and potential delays in clinical development could impact progress. The transition to a new independent auditor may also present short-term operational adjustments.

NovaBridge's moat is anchored in its diversified clinical-stage pipeline of innovative biologics in oncology and ophthalmology, supported by strategic collaborations with established pharmaceutical companies such as AbbVie. Its focus on bispecific antibodies and novel immuno-oncology therapies, combined with regulatory designations like FDA Fast Track status, enhances its competitive positioning. The company's global biotechnology platform and capital-efficient development model contribute to its ability to advance multiple programs concurrently. However, as a clinical-stage biotech, its moat is contingent on successful clinical development, regulatory approvals, and commercialization execution.

• Clinical Development Risk: The success of NovaBridge depends on the outcomes of ongoing and future clinical trials for its drug candidates, which are subject to inherent uncertainties and regulatory scrutiny.
• Regulatory Risk: Obtaining and maintaining regulatory approvals such as FDA Fast Track designation and accelerated approval pathways involves complex processes that may not result in product commercialization.
• Financial Risk: The company has reported net losses and relies on cash reserves and milestone payments to fund operations, which may be insufficient if clinical programs are delayed or unsuccessful.
• Market and Competitive Risk: NovaBridge operates in highly competitive therapeutic areas with multiple companies developing similar or alternative treatments, which may affect market opportunities.
• Operational Risk: Changes in key personnel, including auditors, and the need to manage multiple clinical programs globally may impact operational efficiency and execution.

• NovaBridge Biosciences is a global biotechnology platform company focused on developing innovative medicines, with a recent name change from I-Mab to NovaBridge effective October 29, 2025.
• The company operates through subsidiaries including Visara Inc. (ophthalmology focus) and formerly TJ Biopharma (China operations divested in 2024).
• NovaBridge's pipeline includes oncology and ophthalmology drug candidates, notably givastomig (an immuno-oncology bispecific antibody) and VIS-101 (for wet age-related macular degeneration).
• Givastomig has received FDA Fast Track designation for first-line gastric cancer and for combination therapy in advanced gastric cancer.
• The company has secured FDA alignment on an accelerated approval pathway for givastomig in gastric cancer.
• Clinical development milestones include positive Phase 1b results for givastomig in metastatic gastric cancer, dosing of the first patient in a Phase 2 study with data expected in 2027, and positive Phase 2a topline results for VIS-101.
• NovaBridge plans a Phase 2b program for VIS-101 in wet-AMD in the second half of 2026.
• The company reported a net loss of $46.3 million for the fiscal year ended December 31, 2025, with revenues of $0.63 million for the same period.
• As of December 31, 2025, NovaBridge held $210.6 million in cash and cash equivalents and $0.21 million in short-term investments, with a current ratio of 8.09 and a cash ratio of 7.84, indicating strong liquidity.
• The company has experienced widening net losses in recent years, reflecting ongoing investment in R&D and clinical development.
• NovaBridge has implemented comprehensive cybersecurity risk management practices and has not experienced any material cybersecurity incidents as of the latest filings.
• The company changed its independent registered public accounting firm from PwC to Deloitte effective June 16, 2026, with no disagreements or reportable events noted during the transition.
• NovaBridge's financial statements are prepared under U.S. GAAP and include consolidated results of the company and its subsidiaries.
• The company recognizes revenue primarily from licensing and collaboration agreements, research and development services, and milestone payments, applying ASC 606 revenue recognition standards.
• NovaBridge's business model includes strategic partnerships, such as a global collaboration with AbbVie for the development and commercialization of lemzoparlimab, an anti-CD47 monoclonal antibody.
• The company has a diversified pipeline with multiple clinical-stage assets in oncology and ophthalmology, supported by ongoing clinical trials and regulatory interactions.
• NovaBridge's ADSs are traded in the U.S. with a depositary agreement managed by Citibank, with specified fees and charges for ADS holders.
• The company maintains a strong cash position to support its clinical development programs and operational needs through 2025 year-end.
• Recent news highlights include FDA Fast Track designations for givastomig, positive clinical trial results for VIS-101 and givastomig, and planned clinical programs advancing in 2026.
• The company reported a net loss per share of approximately $0.21 for continuing operations in 2025, reflecting ongoing investment in R&D and clinical development.