US ▾
NBP
Earnings call · Jun 2026 (H1 FY26)

NovaBridge Biosciences H1 FY26 earnings call NBP

Aug 20, 2026 Source

Executive summary

NovaBridge Biosciences H1 FY26 — Strategic Focus on Oncology and Ophthalmology Pipeline Advancement

NovaBridge Biosciences, under new CEO Srishti Gupta, presented its H1 FY26 results, emphasizing a differentiated strategy to advance promising medicines. The company is focused on its lead oncology program, givastomig, which is progressing towards Phase III, and its ophthalmology program, VIS-101, through its majority-owned subsidiary Visara. The strategy involves disciplined capital allocation and leveraging BD and clinical development expertise to bring innovative therapies to market, with a particular focus on European market gaps and women's health.

Highlights

5
  • Reported $216 million in cash and investments as of June 30, 2026, providing meaningful financial flexibility.

  • Givastomig granted Fast Track designation by the FDA in June 2026, increasing confidence in its development pathway.

  • Givastomig Phase Ib data showed a 75% overall response rate (ORR) and a preliminary median progression-free survival (PFS) of 16.9 months in first-line gastric cancer.

  • VIS-101 positive Phase IIa top-line results demonstrated improvements in visual acuity, reductions in retinal thickness, and durable treatment responses.

  • Maintained a debt-free balance sheet.

Concerns

2
  • Competitive landscape in first-line gastric cancer (CLDN18.2 directed approaches)

  • Financing for givastomig Phase III study

Guidance & targets

CategoryTargetConfidence
Givastomig Phase III study initiation
As early as Q4 2026
high materiality
High
Givastomig Phase III interim data readout
2028
high materiality
High
VIS-101 Phase IIb study initiation
Second half of 2026
medium materiality
High
VIS-101 Phase III initiation
Planned
medium materiality
Medium

Segment performance

SegmentRevenueYoYQoQMargin
Oncology (Givastomig)
Phase Ib data showed strong activity across a broad range of CLDN18.2 expression levels. Regulatory progress includes Fast Track designation and eligibility for accelerated approval pathway.
ORR: 75%Median PFS: 16.9 monthsFDA Fast Track designation: Granted June 2026Accelerated approval pathway eligibility: Confirmed by FDA Type B meeting
————
Ophthalmology (VIS-101 via Visara)
VIS-101 is a tetravalent VEGF-A and ANG-2 peptibody designed for robust inhibition and extended durability. Positive Phase IIa results support advancement to Phase IIb.
Phase IIa results: Positive (improvements in visual acuity, reductions in retinal thickness, durable treatment responses, favorable safety profile)
————

Deals & partnerships

AffaMed Originator and partner in Visara, NovaBridge's majority-owned ophthalmology subsidiary.

AffaMed is the originator of VIS-101 and a partner in Visara, which is advancing the ophthalmology program.

Everest Partner conducting the Phase IIb study for VIS-101.

Everest is the partner conducting the Phase IIb study for VIS-101.

Risks & headwinds

Competitive landscape in first-line gastric cancer (CLDN18.2 directed approaches) Current and future

increasingly competitive

Mitigation:Givastomig's differentiation through broader patient population applicability (1+ staining, 1% cells), ease of integration with standard of care (simple infusion, no dose titration, no mandated observation), strong early efficacy (75% ORR, 16.9 months median PFS), and deep regulatory input for lean study design.

Financing for givastomig Phase III study Q4 2026

subject to ongoing planning and financing activities

Mitigation:Strong balance sheet with $216 million in cash and investments, disciplined capital allocation strategy, and flexibility to pursue various financing or partnering options.

What to watch next

Givastomig Phase Ib dose expansion data

October 2026 (ESMO)
Current Encouraging response rates, disease control, PFS (75% ORR, 16.9 months median PFS)
Target Presentation of updated data

Why it matters

Provides further validation of givastomig's efficacy and safety profile, informing registrational development.

Looking ahead, we expect to present the updated Phase Ib dose expansion data at ESMO in October

Q&A highlights

Can you elaborate on your future growth platforms, particularly your differentiation in addressing European market gaps and your focus on women's health, given their difference from current assets?

Srishti Gupta and Mark Hagler explained that their European strategy involves combining NovaBridge's BD and clinical development capabilities with European commercial organizations. They aim to leverage data from outside Europe and low-cost manufacturing to introduce innovative therapies that are differentiated against the reimbursed standard of care. For women's health, they are exploring areas like endometriosis, menopause, injectable fertility, PMOS, osteoporosis, osteopenia, and sarcopenia, which represent high unmet needs.

“differentiation in the European market is really differentiated compared to the standard of care that's reimbursed within the system.”

asked by Daina Graybosch · answered by Srishti Gupta

2 min read 6 chapters

Detailed narrative

New CEO Vision and Strategy

Srishti Gupta, in her first earnings call as CEO, outlined NovaBridge's vision to bridge the gap between exceptional science and patient impact. The company aims to identify promising new medicines, advance them efficiently, and pursue optimal development, financing, or partnering strategies. This approach positions NovaBridge at the intersection of innovation and translation, particularly leveraging opportunities from Asia and focusing on disciplined capital allocation.

Givastomig Oncology Program Progress

The lead oncology program, givastomig, for HER2-negative CLDN18.2 positive PD-L1-positive gastroesophageal cancer, has shown rapid progress. During H1 2026, NovaBridge reported updated Phase Ib results, initiated a global randomized Phase II study, and achieved significant regulatory milestones. The FDA confirmed eligibility for an accelerated approval pathway and granted Fast Track designation in June, increasing confidence in the program's registrational path. Updated Phase Ib dose expansion data is expected at ESMO in October, with Phase III initiation targeted as early as Q4 2026.

VIS-101 Ophthalmology Program Development

VIS-101, advanced through Visara, NovaBridge's majority-owned ophthalmology subsidiary, is designed to address unmet needs in retinal vascular disease by improving durability and reducing treatment burden. Positive Phase IIa top-line results earlier this year demonstrated improvements in visual acuity, reductions in retinal thickness, durable treatment responses, and a favorable safety profile. The company is preparing to initiate a Phase IIb study in H2 2026 to define the optimal dose and advance towards global Phase III development.

Financial Strength and Capital Allocation

NovaBridge reported a strong financial position with approximately $216 million in cash and investments as of June 30, 2026, and a debt-free balance sheet. This financial flexibility is expected to support the company through critical clinical and strategic inflection points, including the anticipated Phase III interim data readout for givastomig in 2028. The company emphasizes disciplined capital allocation, deploying capital thoughtfully while maintaining flexibility for financing, partnering, or corporate structures best suited for each asset.

Future Growth Platforms and European Market Strategy

The company is exploring future growth platforms, including addressing 'European gaps' and women's health. For Europe, the strategy involves combining NovaBridge's business development and clinical development expertise with European commercial organizations. The goal is to bring innovative assets to market by leveraging data generated outside Europe, utilizing efficient regulatory pathways, and potentially low-cost manufacturing to fit national health systems, focusing on unmet needs where current standards of care are less advanced.

Asset Screening and Commercialization Focus

NovaBridge's asset screening process has evolved to prioritize clinical development programs and commercial viability. The company now rigorously evaluates what is required to reach the next value inflection point and achieve registration, alongside a clear pathway for getting therapies to patients. This includes assessing differentiation for physicians and payers, navigating health systems, and understanding prior authorization barriers, reflecting a strong focus on commercialization potential from early stages.

AI-generated summary of the company's earnings call. Not investment advice.