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NBP

NovaBridge Biosciences

NovaBridge Biosciences Q2 FY2020 earnings call

August 31, 2020 · fiscal period ended 2020-06

EPS · actual vs est

$-0.34 / $-0.53Beat +36.1%

Revenue · actual vs est

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Summary

Generated 2020-08-31

Management highlights

Pipeline Development - Lemzoparlimab (TJC4): Completed Phase 1 dose escalation clinical trial in US, validated safety and PK profile; ongoing Phase 1/2 studies in US and China. - TJD5 (anti-CD73 antibody): Phase 1 dose escalating clinical trial in US, parallel trials in China; expected safety and PK/PD results in Q4 2020. - TJM2 (anti-GM-CSF antibody): Evaluated for COVID-19 cytokine release syndrome; Phase 2 study ongoing in US, initiated Phase 1b study in China for rheumatoid arthritis. - TJ202 (anti-CD38 antibody): Two parallel registrational studies in China for multiple myeloma, on track for patient recruitment in 2020, expected BLA filing in mid-2021 to Q3 2021. - Early stage pipeline: TJ210, TJ-CD4B, etc., advancing towards clinical development. ### Corporate Development - Appointed Ivan Yifei Zhu as Chief Commercial Officer; focus on building commercialization infrastructure. - Opened Hong Kong office in May 2020; plan to build R&D center in San Diego starting late 2020 for translational medicine, etc.

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Segment performance

For the six months ended June 30, 2020, net revenues were nil compared to RMB 15 million for the same period in 2019. R&D expenses were RMB 442.3 million (US$62.6 million) vs. RMB 265.1 million in 2019. Administrative expenses were RMB 171.4 million (US$24.3 million) vs. RMB 574.6 million in 2019. Net loss was RMB 582.9 million (US$82.5 million) vs. RMB 857.3 million in 2019. Non-GAAP net loss (excluding share based compensation) was RMB 353.1 million (approx. $50 million) vs. RMB 491 million in 2019.

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Guidance

Forward-Looking Statements - Expect IND submissions for early stage pipeline assets like TJ210. - Plan to initiate Phase 2 clinical trial for TJ107 in glioblastoma patients with lymphopenia. - Expect to obtain IND approval for TJ101's registrational trial. - Progress ongoing Phase 2 clinical trial for TJ301 in ulcerative colitis towards completion.

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Risks

Risks - Clinical trial risks: Uncertainties in clinical trial outcomes, safety profiles, and regulatory approvals. - Market competition: Competition from other biotech companies in immuno-oncology and related areas. - Regulatory risks: Changes in regulatory requirements that could impact clinical development and approval timelines.

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Q&A highlights

Q: About CD47 antibody (lemzoparlimab), future R&D plans on bi-specific products?

A: Two CD47 related bi-specific programs (CD47 GM-CSF, CD47 PD-L1) at CMC preclinical stage, expect IND filing next year.

Q: Regarding TJM2 Phase 2 study for Cytokine Release Syndrome, potential FDA attitude?

A: Successfully advanced from Phase 1 to Phase 2, communicating with FDA to finalize endpoint and population for potential registrational trial.

Q: How healthcare reforms create opportunity for China biotechs?

A: Regulatory reforms, funding growth, talent return, and reimbursement efforts support Chinese biotechs.

Q: Where TJD5 fits in treatment paradigm if approved?

A: Works synergistically with PD-1/PD-L1 therapies to create favorable tumor microenvironment, positioned to combine with them to increase response rate.

Q: Competition in CD47 market, TTI-621 toxicity cause?

A: TJC4 is highly differentiated, rapidly advancing clinical development; TTI-621's thrombocytopenia due to ITT function of the molecule.

Q: Commercialization plan, sales team headcount?

A: Aim to form core immuno-oncology sales team of 150-200 people, focusing on hematological malignancies.

Q: TJM2 as substitute for steroids in COVID-19 treatment?

A: GM-CSF targets cytokine release associated with COVID-19 without compromising immune system like steroids do.

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Key numbers

Reported versus consensus

Earnings calendar feed

MetricReportedConsensusDeltaPrior year
EPS$-0.34$-0.53+36.1%
Revenue

Transcript

August 31, 2020

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