NORTHPOINTE BANCSHARES INC Q4 FY2021 earnings call

• 2021 was dynamic for I-Mab with 20 key clinical milestones achieved, including completing registrational trial for felzartamab. Pipeline advanced with 3 of 4 registrational trials, 11 phase 2, and 3 phase 1 trials expected by end of 2022.
• Entered partnership deals in 2021, including $350 million strategic commercial partnership with Jumpcan for eftansomatropin alfa and partnership with Roche Diagnostics. Maintained strong cash position with $671 million cash on hand, sufficient to fund operations through 2025.
• Addressed regulatory concerns by working towards switch to U.S.-based auditors recognized by U.S. PCAOB and pursuing dual listing on Hong Kong Stock Exchange. Pipeline approaching near term commercialization with expectation to file 4 BLAs and launch products between 2022 and 2025.

In the full year ended December 31, 2021, net revenues were RMB88 million (US$13.8 million) compared to RMB1.543 billion in 2020. R&D expenses for 2021 were RMB1.213 billion (US$190 million) compared to RMB985 million in 2020. Administrative expenses for 2021 were RMB899 million (US$141 million) compared to RMB402 million in 2020. Cash and cash equivalents and short term investments amounted to total RMB4.3 billion (US$671 million) as of December 31, 2021, compared with RMB4.8 billion as of December 31, 2020.

• Expect to advance pipeline to include 3 of 4 registrational trials, 11 phase 2 clinical trials and 3 phase 1 clinical trials by end of 2022.
• Cash is sufficient to fund business operations through 2025 for about 3 years.
• Aim to achieve 20 key clinical milestones in 2022, including initiation of one or two registrational trials for lemzoparlimab and set of five clinical data readout events.

• Regulatory risks related to U.S. HFCAA and ADR audit inspection requirements. Efforts underway to mitigate by engaging PCAOB-inspectable accounting firm and pursuing dual listing on Hong Kong Stock Exchange.

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

A: Preliminary data on lemzoparlimab in combination with azacitidine in MDS shows ORR and CR rates comparable to magrolimab, with better safety profile. MTD not reached in any dose regimens. Plan to initiate Phase 3 registration trial in first-line MDS in China this year.

Q: How to deal with regulatory risks associated with HFCAA?

A: Taking actions like engaging PCAOB-inspectable auditor and pursuing dual listing on Hong Kong Stock Exchange. Positive signals from regulators working towards a solution.

Q: Details on Phase 2 uliledlimab data expected at ASCO?

A: Phase 2 trial with uliledlimab in combination with toripalimab in advanced solid tumors has safety analysis for over 90 patients and efficacy data in over 40 evaluable patients. Plan to analyze biomarker correlation. Continuing clinical development for global licensing.

Q: Latest update on TJ202's BLA submission in China?

A: Slight delay in submitting BLA package due to discussion with CDE on new policy and embedding localized manufacturing plan. Expect to submit new BLA package soon in 2022