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NBP

NovaBridge Biosciences

NovaBridge Biosciences Q4 FY2022 earnings call

March 31, 2023 · fiscal period ended 2022-12

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Summary

Generated 2023-03-31

Management highlights

  • The company faced challenges like geopolitical issues, macroeconomic factors, and COVID-19 but repositioned business, streamlined structure and workforce, and prioritized 5 key assets, reducing cash burn rate. - Achieved 13 key clinical milestones in 2022, including positive results for lemzoparlimab, uliledlimab, and givastomig. - Highlighted assets: eftansomatropin alfa completed Phase 3 trial enrollment, expect data readout in H2 2023; felzartamab Phase 3 study on track; lemzoparlimab (CD47 antibody) has favorable safety and efficacy profiles, Phase 3 trial for first line MDS initiated; uliledlimab (CD73 antibody) shows robust efficacy in NSCLC, expect data readout and biomarker-guided pivotal trial in 2023; givastomig (Claudin18.2 4-1BB bispecific antibody) has ongoing Phase 1 trial with favorable safety and efficacy signals.
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Segment performance

Total revenue for the full year of 2022 was RMB-221.6 million (US$32.1 million) compared with RMB88 million in 2021. The decrease was primarily due to a one-off accounting treatment. R&D expenses for 2022 were RMB904.9 million (US$131 million) compared with RMB1.2 billion in 2021, mainly due to reduced demand for pipeline products and lower share-based compensation. Administrative expenses in 2022 were RMB720 million (US$104.4 million) compared with RMB899 million in 2021, due to lower share-based compensation and optimized expenses. Net other expenses in 2022 were RMB126.6 million (US$18.4 million) compared with net other income of RMB83.2 million in 2021, mainly due to unrealized exchange losses from RMB-USD exchange rate fluctuations.

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Guidance

  • Expect Phase 3 data readout on eftansomatropin in H2 2023 followed by BLA submission. - Initiate Phase 3 clinical trial for lemzoparlimab as first line MDS treatment. - Expect additional data readout for uliledlimab Phase 2 NSCLC trial in 2023 and plan biomarker-guided pivotal study. - Continue with givastomig Phase 1 trial and expect to initiate new INDs in 2023.
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Risks

  • Geopolitical issues such as ADR delisting risks. - Macroeconomic factors including interest rate hikes. - COVID-19 pandemic. - Risks related to forward-looking statements where actual results may differ materially from those mentioned.
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Q&A highlights

Q: Has I-Mab been able to resolve its delisting risks fully?

A: Jingwu Zang said most delisting risk has been mitigated by working with auditor through PCAOB new rules.

Q: Regarding the Phase 2 trial of CD73 antibody in Stage 4 non-small cell lung cancer, could you share more on patient baseline characteristics?

A: Andrew Zhu said the study targets treatment naive Stage 4 NSCLC patients, naive to all treatments including PD-1.

Q: How do you think about the data for zolbetuximab and implications for Claudin18.2 as a target, and how is givastomig positioned?

A: Andrew Zhu said zolbetuximab has validated Claudin18.2 as a target in gastric cancer, and givastomig has unique design covering wider Claudin18.2 expression, favorable safety profile with local T cell activation and less GI toxicity.

Q: Any concerns regarding the toxicity of 4-1BB agonists and more results from givastomig's dose escalation study?

A: Andrew Zhu said givastomig's bispecific design spares systemic toxicity, and the Phase 1 trial shows favorable safety with ongoing data.

Q: How to think about expected cash burn rate in 2023 and bringing in additional assets?

A: Richard Yeh said expected net burn rate in 2023 is US$130 million to US$140 million; Andrew Zhu said I-Mab focuses on key assets but will reassess licensing efforts for additional valuable assets.

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March 31, 2023

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