NovaBridge Biosciences Q2 FY2021 earnings call

• Corporate focus: Twofold goal to advance clinical pipeline towards product portfolio and transform from clinical stage biotech to global biopharma. Focus on team execution to advance pre-BLA and late-stage assets, and developing next-generation immuno-oncology assets through second and third wave innovation.
• Pipeline progress: Achieved 13 pipeline milestones since the start of 2021, including BLA submission for felzartamab in Q4 2021, ongoing registrational trials for felzartamab, TJ101, etc., and multiple Phase 1/2 clinical trials. Lemzoparlimab, uliledlimab, and other assets have significant clinical progress.
• Manufacturing and commercialization: Progress in building manufacturing facility in Hangzhou, with pilot plant ready by mid-2022 and commercial production by end-2023. Initial commercialization capability built for product launch in China.
• Awards and governance: Received awards for innovation and growth, and focused on strengthening corporate governance and social responsibilities, including forming ESG committee and making donations.

As of June 30, 2021, total cash (including cash equivalents, restricted cash, and short-term investments) was RMB 4.8 billion (US$739.2 million), consistent with the amount as of December 31, 2020. Net revenues for the six months ended June 30, 2021 were RMB 17.8 million (US$2.8 million), compared to nil in the same period of 2020. R&D expenses for the first half of 2021 were RMB 593 million (US$91.8 million), an increase from RMB 442.3 million in the same period of 2020, primarily due to increased CRO service fees for advancing the pipeline. Administrative expenses for the first half of 2021 were RMB 451.5 million (US$69.9 million), up from RMB 171.4 million in 2020, driven by higher share-based compensation, professional service expenses, and increased headcount. GAAP net loss for the six months ended June 30, 2021 was RMB 8 billion (US$166.7 million), compared to RMB 582.9 million in the same period of 2020. Non-GAAP net loss, excluding share-based compensation expenses, was RMB 729.4 million (US$113 million) in 2021, up from RMB 353.1 million in 2020.

• Dual listings: Expect dual listings on STAR Market in Shanghai and Hong Kong's Chapter 18A Market to be completed by the end of 2022, aiming to broaden shareholder base and lower cost of capital.
• Pipeline milestones: Aim to start registrational studies for lemzoparlimab and meet pre-BLA milestones for TJ101 and felzartamab second-line treatment by end of 2021.
• Partnerships: Expect additional milestone payments from AbbVie in the next 12-18 months, with total potential payments up to $175 million, and ongoing discussions for BD partnerships on other assets.

• Geopolitical concerns: Potential uncertainties related to geopolitical factors, but biotech industry in China is seen as receiving government support.
• Regulatory uncertainties: Uncertainties around regulations in China, but biotech industry is considered to be relatively insulated due to highly differentiated pipeline assets and less crowded competition in certain segments.

Q: Kelly Shi asked about the level of detail for lemzoparlimab's early China trial topline readout at ASH and efficacy bar for the program, and about AbbVie partnership milestone payments.

A: Jingwu Zang stated lemzoparlimab's U.S. trial showed excellent clinical results with good safety and efficacy signals, with data to be released at ASH. Jielun Zhu mentioned expecting $50 million milestone payment in second half of 2021 and additional $125 million in next year for AbbVie partnership.

Q: Jennifer Kim asked about navigating regulatory uncertainty in China and fundamental value as an innovative biotech.

A: Jielun Zhu stated biotech industry in China is supported by government, our assets are highly differentiated and insulated from some NRDL issues, and we are diversifying listings to manage geopolitical risk.

Q: Joseph Catanzaro asked about BD deals in 2021, partner terms for uliledlimab, and early stage pipeline programs.

A: Jingwu Zang mentioned active BD discussions for uliledlimab and other assets, similar to AbbVie partnership, and early stage assets like TJ107 and Enoblituzumab have significant value creation potential with upcoming proof-of-concept data.