NORTHPOINTE BANCSHARES INC Q4 FY2022 earnings call

• Faced challenges like geopolitical issues, macroeconomic factors, and COVID-19 in 2022. Responded with strategic efforts to reposition business and prioritize pipeline, leading to streamlined structure and workforce.
• PCAOB report in December 2022 vacated previous determination, removing delisting risk related to HFCAA.
• Achieved 13 key clinical milestones in 2022 for five key assets: eftansomatropin alfa (Phase 3 trial enrollment completed, data readout expected H2 2023), felzartamab (Phase 3 study on track), lemzoparlimab (Phase 3 stage, favorable safety and efficacy), uliledlimab (Phase 2 trial in NSCLC with positive data, biomarker-guided pivotal trial planned), givastomig (Phase 1 trial ongoing, single agent efficacy signals observed).
• Expected catalysts in near future: Phase 3 data readout for eftansomatropin in H2 2023, initiation of Phase 3 trial for lemzoparlimab as first line MDS treatment, data readout for uliledlimab Phase 2 in 2023, and sharing of Phase 1 data for givastomig in H2 2023.

In 2022, total revenue was RMB-221.6 million (US$32.1 million) compared to RMB88 million in 2021. Research and development expenses were RMB904.9 million (US$131 million) in 2022 versus RMB1.2 billion in 2021. Administrative expenses in 2022 were RMB720 million (US$104.4 million) compared to RMB899 million in 2021. Net other expenses in 2022 were RMB126.6 million (US$18.4 million) compared to net other income of RMB83.2 million in 2021. The strong cash position at the end of 2022 was US$514 million, expected to support operations over the next three years.

• Expect Phase 3 data readout on eftansomatropin alfa in the second half of 2023 followed by BLA submission.
• Initiate Phase 3 clinical trial for lemzoparlimab as first line MDS treatment, with goal of first-to-market and first-in-class in China.
• Expect additional data readout for uliledlimab Phase 2 non-small cell lung cancer trial in 2023, including ORR and PFS, and plan biomarker-guided pivotal study.
• Share Phase 1 data of givastomig in the second half of 2023.

• Geopolitical issues such as ADR delisting risks (now mitigated but still potential residual risks).
• Macroeconomic factors including interest rate hikes.
• Uncertainties related to clinical trial outcomes and regulatory approvals for pipeline assets.

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

A: Jingwu Zang stated 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, details on patient baseline characteristics like PD-L1 expression and prior PD-1 treatment?

A: Andrew Zhu mentioned the trial targets treatment naive Stage 4 non-small cell lung cancer patients, naive to all treatments including PD-1.

Q: Concerns regarding 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 associated with 4-1BB, with ongoing Phase 1 trial showing mild adverse events and efficacy signals.

Q: Expected cash burn rate in 2023 and thoughts on bringing in additional assets?

A: Richard Yeh said expected net burn rate in 2023 is US$130 million to US$140 million. Andrew Zhu mentioned focusing on key internal assets but will critically assess licensing efforts for external assets to generate cash flow