BeyondSpring Inc.

For Q4 2021, R&D expense was $5.8 million versus $8.4 million a year ago, G&A expense was $5.0 million versus $10.4 million, and net loss attributable to the company was $9.5 million versus $17.6 million. For full-year 2021, R&D expense was $36.9 million versus $41.8 million, G&A expense was $30.7 million versus $22.6 million, and net loss attributable to the company was $64.2 million versus $61.0 million. Cash balance at Dec. 31, 2021 was $41.6 million and short-term investments were $30.7 million, for total liquidity of $72.4 million. Management said this should be sufficient to support ongoing operations and clinical programs over the next year. No revenue or EPS figures were reported on the call, and no formal next-quarter or full-year revenue guidance was given.

Lan Huang framed the quarter around operational streamlining after the FDA complete response letter and said the company is now focused on near-term value-creation opportunities. She emphasized China as the key near-term regulatory path for plinabulin in both CIN and NSCLC, while still continuing U.S. discussions. Her tone was cautiously optimistic, repeatedly citing positive data, strong partnerships, and long patent protection through 2037.

Elizabeth Czerepak said Q4 R&D fell to $5.8 million from $8.4 million due mainly to lower clinical development and personnel costs, while G&A fell to $5.0 million from $10.4 million, helped by lower share-based compensation and a $2.0 million non-cash credit. For the full year, R&D was $36.9 million and G&A was $30.7 million; she noted the $2.9 million FDA NDA fee is expected to be refunded in the second quarter of 2022, and said higher pre-commercialization spending drove the G&A increase but should not continue this year. She ended with $72.4 million in cash and short-term investments at year-end and said that should support operations over the next year.

Analysts pressed on the China approval timeline, the FDA’s requirements for a second CIN study, and whether U.S. NSCLC filing plans were slipping. Management said Chinese CIN review is ongoing with multiple positive meetings, but timing remains uncertain; for the U.S., they said the FDA wants more data and discussions are active on the design of a second CIN study. On NSCLC, management said no second study has been specifically discussed yet, but the FDA’s concern appears focused on the relevance of the mostly-China dataset to the U.S. population.