BeyondSpring Inc. Q1 FY2021 earnings call

• Dr. Lan Huang highlighted that in the past quarter, the U.S. FDA filed the NDA for plinabulin with an anticipated PDUFA date of November 30, 2021, and received priority review. Progressed in the DUBLIN-3 Phase 3 non-small-cell lung cancer study and checkpoint inhibitor combination studies. Presented Phase 1 data at ASCO on plinabulin combination with nivolumab and ipilimumab. Initiated a Phase 1b/2 trial with plinabulin, PD-1/PD-L1 antibody, and radiation therapy.
• Dr. Ramon Mohanlal announced an R&D Day on June 25 to discuss the anti-cancer development strategy for plinabulin, focusing on reversal of resistance to I/O therapy, converting cold tumors to hot tumors, and preventing immune-related adverse events.
• Richard Daly discussed prelaunch activities for commercial launch in the U.S., including market preparation, account outreach, NCCN guideline submission, and patient support services. Mentioned parallel path in China with commercial team build-out and partnership discussions.
• Elizabeth Czerepak provided financial update, highlighting R&D, G&A, net loss figures, and cash balance.

In the first quarter of 2021, R&D expenses were $11.3 million compared to $13.7 million in the same period last year, a decrease of $2.4 million primarily due to lower clinical trial expenses and noncash stock-based compensation, offset by increased manufacturing costs and regulatory filing costs. G&A expenses were $6.4 million in Q1 2021 vs. $2.9 million in Q1 2020, an increase of $3.5 million due to higher personnel costs, noncash stock-based compensation, and pre-commercialization activities for plinabulin. Net loss in Q1 2021 was $17.0 million vs. $16.1 million in Q1 2020. Cash balance at the end of Q1 was $90.6 million.

• U.S. FDA NDA filing for plinabulin with PDUFA date of November 30, 2021, and priority review received. - Anticipated top line overall survival data from DUBLIN-3 Phase 3 study midyear. - Planning to launch plinabulin in early 2022 in the U.S.

Q: Two questions: confidence level that plinabulin won't have an FDA advisory committee and thoughts on using triple plinabulin plus I/O in non-small-cell lung cancer.

A: Dr. Lan Huang stated FDA has no AdCom plan due to positive elements like no 483 after inspection and large AOM meeting. Ramon Mohanlal mentioned moving triple plinabulin plus I/O combinations into first line non-small-cell lung cancer as next steps.

Q: Specifics on Phase 3 DUBLIN study progress and patient baseline characteristics.

A: Dr. Lan Huang said reached at least 439 death events for final analysis, still cleaning data, guiding midyear. Baseline characteristics are balanced with measurable lung lesion patients and EGFR wild-type, with R&D Day to detail study designs.

Q: Regulatory sentiment and NCCN guideline impact on plinabulin.

A: Dr. Lan Huang mentioned FDA independence from NCCN but gratitude for breakthrough and priority review. Richard Daly discussed NCCN guideline change increasing addressable market, physicians and payers comfortable with updated guidelines, and SG&A ramp for launch