NovaBridge Biosciences Q4 FY2021 earnings call

Key Achievements in 2021 - Met 20 key clinical milestones, including completing registrational trial for felzartamab as third-line multiple myeloma therapy and submitting BLA package in China. - Achieved positive data readouts for lemzoparlimab and uliledlimab. - Entered strategic partnership deals, including $350 million with Jumpcan for eftansomatropin alfa and partnership with Roche Diagnostics. - Maintained strong cash position with $671 million cash on hand. ### Pipeline Progress - Pipeline advanced with 10 clinical assets, including lemzoparlimab in Phase 2/3, uliledlimab in Phase 2, felzartamab near BLA, and eftansomatropin alfa in Phase 3. - Lemzoparlimab showed favorable safety and efficacy in MDS and NHL trials. - Uliledlimab had preliminary encouraging results in solid tumor combination trials. ### Commercialization Strategy - Focus on near-term commercialization of products like felzartamab, lemzoparlimab, and eftansomatropin alfa. - Building commercial team and leveraging partnerships like Jumpcan for eftansomatropin alfa. - Planning BLA filings and product launches between 2022-2025. ### Financial Highlights - 2021 net revenues $13.8 million, R&D expenses $190 million, administrative expenses $141 million. - Strong cash position to fund operations through 2025.

For the full year ended December 31, 2021, net revenues were RMB88 million (US$13.8 million). R&D expenses were RMB1.213 billion (US$190 million) due to rapid pipeline advancement. Administrative expenses were RMB899 million (US$141 million) primarily due to higher share-based compensation and payroll expenses. Cash and cash equivalents and short-term investments amounted to RMB4.3 billion (US$671 million) as of December 31, 2021.

2022 Milestones - Aim to achieve 20 key clinical milestones, including initiating registrational trials for lemzoparlimab. - Expect pipeline to have 3-4 registrational trials, 11 Phase 2, and 3 Phase 1 trials by end of 2022. - Plan to file 4 BLAs and launch products between 2022-2025. - Cash position sufficient to support operations through 2025, with expected milestone payments from out-licensing deals.

Regulatory Risks - Concerns related to U.S. HFCAA and ADR audit inspections. - Proactive measures taken include engaging PCAOB-inspectable auditor for 2022 audit and pursuing dual listing on Hong Kong Stock Exchange. - Positive signals from U.S. and China regulators working towards a solution.

Q: Could you provide more on lemzoparlimab in combination with azacitidine data and safety differentiation?

A: Preliminary data in MDS is comparable to magrolimab, with better safety profile. Molecule designed to avoid red blood cell binding. Plan to initiate Phase 3 trial in China this year.

Q: How to deal with HFCAA regulatory risk?

A: Engaging PCAOB-inspectable auditor and accelerating dual listing on Hong Kong Exchange. Working towards resolution with regulators.

Q: Details on uliledlimab Phase 2 data at ASCO?

A: Phase 2 trial with uliledlimab and toripalimab in over 90 patients, evaluating efficacy in over 40 evaluable patients and biomarker correlation. Working on global licensing collaboration.

Q: Commercialization efforts and cash burn?

A: Near-term product portfolio includes felzartamab, lemzoparlimab, etc., with expected sales revenue. Cash burn for 2022-2023 expected to be $180 million to $220 million, with sufficient cash to support operations.

Q: Update on TJ202/BLA submission for felzartamab?

A: Slight delay due to CDE policy discussion and localized manufacturing plan. Expect to submit BLA soon with localized plan to reduce costs.