NORTHPOINTE BANCSHARES INC
NORTHPOINTE BANCSHARES INC Q2 FY2020 earnings call
August 31, 2020 · fiscal period ended 2020-06
EPS · actual vs est
Revenue · actual vs est
Summary
Generated 2020-08-31
Management highlights
- Pipeline Development: Lemzoparlimab (TJC4) completed Phase 1 dose escalation in U.S. with positive safety and PK profile; TJD5 in Phase 1 dose escalating trial in U.S. and China; TJM2 evaluated for COVID-19 cytokine release syndrome; TJ202 in registrational studies in China; TJ301 in Phase 2 for ulcerative colitis; early stage pipelines advancing. - Corporate Development: Appointed Ivan Yifei Zhu as Chief Commercial Officer; opened Hong Kong office; plans to build R&D center in San Diego.
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) in 2020 H1 versus RMB 265.1 million in 2019 H1. Administrative expenses were RMB 171.4 million (US$24.3 million) in 2020 H1 versus RMB 574.6 million in 2019 H1. Net loss was RMB 582.9 million (US$82.5 million) in 2020 H1 compared to RMB 857.3 million in 2019 H1. Non-GAAP net loss, excluding share based compensation, was RMB 353.1 million (approx. $50 million) in 2020 H1 vs RMB 491 million in 2019 H1.
Guidance
- Forward-looking on pipeline milestones like filing BLA for TJ202 in mid-2021, IND approval for TJ101, initiation of Phase 2 for TJ107, etc. - Confidence in science and ability to deliver value to patients and shareholders.
Risks
- Risks related to clinical trial outcomes, market competition, regulatory uncertainties, and potential differences between actual results and forward-looking statements.
Q&A highlights
Q: About CD47 antibody lemzoparlimab, future R&D plans and bi-specific products.
A: Two CD47 related bi-specific programs at CMC preclinical stage; clinical development plan for TJC4 focusing on AML/MDS registration and solid tumor combo studies.
Q: Regarding TJM2 Phase 2 study for CRS, potential as registrational trial and FDA attitude.
A: Advanced from Phase 1 to Phase 2, communicating with FDA to prioritize clinical protocol for potential registrational trial.
Q: How healthcare reforms create opportunities for China biotechs; potential of Chinese market; role of TJD5 in treatment paradigm.
A: Regulatory reforms, funding, talent, and reimbursement support growth; Chinese market likely to become leading for innovative therapies; TJD5 works synergistically with PD-1/PD-L1 therapies to enhance efficacy.
Q: Competition in CD47 market, TTI-621 toxicity, and commercialization plan.
A: TJC4 differentiated with minimal RBC binding and favorable PK; TTI-621's thrombocytopenia due to ITT function; commercialization plan to form core sales team for hematology market.
Q: Updates on TJC4 potential partners and TJ-CD40 bi-specific antibody.
A: Ongoing discussions with potential partners for TJC4; TJ-CD40 bi-specific for gastric and pancreatic cancers, at preclinical stage with IND filing planned.
Q: Use of TJM2 as substitute for steroids in severe COVID-19 patients.
A: TJM2 targets cytokine release specifically, avoiding immune system suppression unlike steroids, with unique advantage in treating COVID-19 related CRS.
Key numbers
Reported versus consensus
Earnings calendar feed
| Metric | Reported | Consensus | Delta | Prior year |
|---|---|---|---|---|
| EPS | $-0.34 | $-0.53 | +36.1% | — |
| Revenue | — | — | — | — |
Transcript
August 31, 2020Full transcript unavailable for redistribution
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