NovaBridge Biosciences SEC Filings

NovaBridge Biosciences reports that the FDA has confirmed givastomig’s potential eligibility for an accelerated approval pathway in first-line Her2-, CLDN 18.2+, PD-L1+ gastroesophageal cancer. This decision follows positive Phase 1b data from a combination trial in gastric cancer.

The company plans a registrational Phase 3 trial in combination with immunochemotherapy, targeted to start as early as Q4 2026, using objective response rate as the primary endpoint for accelerated approval. In Phase 1b, givastomig produced a 75% objective response rate across 52 evaluable patients, with 77% at 8 mg/kg and 73% at 12 mg/kg.

Median progression-free survival reached 16.9 months, with an 82% 6‑month landmark PFS rate in 53 evaluable patients, and overall tolerability was described as good without dose-dependent toxicity. Givastomig, a bispecific Claudin 18.2 x 4‑1BB antibody, is positioned as a potential first-in-class and best-in-class therapy in this setting.

NovaBridge Biosciences reported positive Phase 2a results for VIS-101, a dual VEGF-A and ANG-2 inhibitor being developed for wet age-related macular degeneration and other retinal vascular diseases. In 38 patients treated with 3 mg or 6 mg doses, VIS-101 delivered rapid, robust and durable responses.

Patients showed mean best corrected visual acuity gains of more than 10 ETDRS letters and median central subfield thickness reductions of 100–150 µm after three loading injections. Around two thirds of patients were retreatment-free at four months and about half remained retreatment-free at six months, with a favorable safety profile and no dose-limiting toxicity.

The company plans to start a dose-determining Phase 2b study in the second half of 2026 and a global Phase 3 program in 2027. NovaBridge also highlighted a cash balance of $228 million, which it expects will fund operations through 2028 to reach key clinical milestones for VIS-101 and other pipeline assets.

NovaBridge Biosciences furnished a press release announcing a virtual business update call to review Phase 2a clinical data for its ophthalmology candidate VIS-101 in wet age-related macular degeneration. The webcast is scheduled for Monday, March 9, 2026, at 9:00 AM ET and will be accessible live and as a replay via the company’s website.

VIS-101 is described as a purpose-designed, bispecific, tetravalent dual VEGF-A/ANG-2 inhibitor, intended to offer more potent and durable treatment for wet AMD, diabetic macular edema, and retinal vein occlusion. It is currently completing a randomized, dose-ranging Phase 2a study in wet AMD, with global rights (outside Greater China and certain Asian territories) held by NovaBridge’s majority-owned subsidiary Visara.

The release also highlights NovaBridge’s broader pipeline, led by givastomig, a Claudin 18.2 x 4-1BB bispecific antibody in a global Phase 2 study for Claudin 18.2-positive gastric and other gastrointestinal cancers, along with collaborations on ragistomig and ownership of rights outside China to uliledlimab, an anti-CD73 antibody targeting adenosine-driven immunosuppression in cancer.

NovaBridge Biosciences furnished an investor presentation detailing its transition into a global platform biotech with four clinical-stage assets in oncology and ophthalmology. Lead asset givastomig, a CLDN18.2 x 4-1BB bispecific for first-line gastric and related cancers, showed objective response rates of 75% across 8 mg/kg and 12 mg/kg cohorts and median progression-free survival of 16.9 months at 8 mg/kg in a Phase 1b study, with responses seen even in patients with low CLDN18.2 and low PD-L1 expression.

Ophthalmology candidate VIS-101, a VEGF x Ang-2 bispecific, delivered rapid vision gains sustained beyond 16 weeks in a Phase 2 wet AMD trial after three loading doses, supporting potential best-in-class durability, with topline Phase 2 data expected in Q1 2026 and Phase 3 readiness targeted by the end of 2026. The company also highlighted encouraging early data and differentiation claims for immuno-oncology programs ragistomig (PD-L1 x 4-1BB) and uliledlimab (CD73 mAb) in solid tumors and NSCLC.

Financially, NovaBridge reported $228.3 million in cash, cash equivalents and short-term investments as of September 30, 2025, no outstanding debt, and an anticipated cash runway extending to the fourth quarter of 2028, intended to support its planned clinical development and business development activities.

NovaBridge Biosciences appointed Dr. Emmett T. Cunningham Jr., MD, PhD, MPH, as Vice Chairman of its board of directors and as a member of the Research and Development Committee, effective immediately. He is Executive Chairman and co-founder of NovaBridge subsidiary Visara and previously held senior roles at Blackstone, Clarus Ventures, Eyetech, and Pfizer.

As Vice Chairman and R&D Committee member, Dr. Cunningham will receive a $50,000 annual cash retainer, an initial stock option grant with a grant date fair value of $300,000, and ongoing equity grants under the non-executive director compensation policy. The report also highlights NovaBridge’s pipeline, including givastomig for Claudin 18.2-positive cancers, ragistomig and uliledlimab in oncology, and VIS-101 in Phase 2a for wet AMD.

NovaBridge Biosciences has enrolled the first patient in its global, randomized Phase 2 study of givastomig for first-line metastatic gastric cancer. Givastomig is a Claudin 18.2 x 4-1BB bispecific antibody given with nivolumab and mFOLFOX6 immunochemotherapy.

The company highlights prior Phase 1b combination data in HER2-negative gastric cancer, where givastomig achieved a 75% objective response rate, a 16.9-month median progression-free survival and an 82% six-month landmark PFS, with good overall tolerability. These results support the move into Phase 2.

The Phase 2 trial plans to enroll about 180 patients with CLDN18.2-positive, PD-L1–positive gastric and related cancers, randomized between two givastomig doses and control. Top-line results are expected in 2027, while detailed Phase 1b expansion data are planned for a major medical conference in the second half of 2026.

NovaBridge Biosciences filed an amended Form 6-K to furnish an updated investor presentation detailing its strategy, pipeline and finances. The company positions itself as a hub-and-spoke platform sourcing early-stage assets and driving them to clinical proof-of-concept, especially in oncology and ophthalmology.

The pipeline centers on four clinical-stage programs: givastomig (CLDN18.2 x 4-1BB bispecific) for first-line gastric and other CLDN18.2-positive cancers, ragistomig (PD-L1 x 4-1BB bispecific) for solid tumors, uliledlimab (CD73 antibody) for non-small cell lung cancer, and VIS-101 (VEGF x Ang-2 bispecific) for wet AMD and DME.

In a Phase 1b study in first-line gastroesophageal cancer, givastomig plus nivolumab and chemotherapy showed an objective response rate of 75% across 52 efficacy-evaluable patients and median progression-free survival of 16.9 months, with manageable safety. VIS-101 Phase 2 interim data in wet AMD suggest vision gains sustained beyond 16 weeks.

The presentation notes no outstanding debt and cash, cash equivalents and short-term investments of $228.3 million as of September 30, 2025, with an expected cash runway into the fourth quarter of 2028. Key upcoming events include Phase 2 VIS-101 topline data in wet AMD in the first quarter of 2026 and multiple planned studies and readouts for givastomig, ragistomig and uliledlimab through 2027.

NovaBridge Biosciences furnished an investor presentation outlining its evolving “hub-and-spoke” biotech platform, four clinical-stage assets and a strong balance sheet. Lead oncology candidate givastomig showed objective response rates around 75% and median progression-free survival of 16.9 months in first-line gastric cancer combinations.

The company is also advancing ophthalmology bispecific VIS-101, CD73 antibody uliledlimab and PD-L1×4‑1BB bispecific ragistomig, with multiple Phase 1/2 milestones in 2026–2027. NovaBridge reports no debt and cash, cash equivalents and short‑term investments of $228.3 million, guiding an operational runway to the fourth quarter of 2028.

NovaBridge Biosciences large shareholder affiliates of CBC Group, including multiple C‑Bridge and I‑Bridge funds and vehicles, filed Amendment No. 2 to Schedule 13D for the company’s ordinary shares and ADSs.

The filing shows that Wei Fu may be deemed to beneficially own 30,499,709 ordinary shares, or 11.5% of NovaBridge’s outstanding ordinary shares, based on 265,169,373 ordinary shares outstanding following an underwritten offering described in a Form 6‑K. Other reporting entities, such as C‑Bridge Healthcare Fund II, L.P. and C‑Bridge Capital GP, Ltd., report beneficial ownership stakes ranging from 0.9% to 8.8%.

The filing also explains that each ten (10) ADSs represents twenty‑three (23) ordinary shares, and notes that Nova Aqua Limited recently purchased ADSs in open‑market broker transactions, detailed in a referenced Schedule I.