BeyondSpring(US:BYSI)2021-12-29 16:00Clinical Development - Positive Phase 3 data for plinabulin/docetaxel combination showed superior efficacy in overall survival, progression-free survival (PFS), and overall response rate (ORR) compared to docetaxel alone in NSCLC patients[1] - NDA for plinabulin-G-CSF combination in CIN prevention is under review in China, with a complete response letter received from the U.S. FDA[7] - The Company anticipates submitting its NDA for plinabulin in NSCLC in the second half of 2022[3] - Phase 2 data from the Big Ten Cancer Research Consortium study on plinabulin combined with nivolumab and ipilimumab is expected in the second half of 2022[9] - The combination of plinabulin and docetaxel demonstrated an 18.4% relative improvement in Quality of Life benefit[5] Financial Performance - Net loss attributable to the Company was $18.4 million for Q3 2021, compared to $14.5 million for Q3 2020[10] - Year-to-date net loss for 2021 was $54.7 million, up from $43.4 million in the same period of 2020[11] - Total revenue for the three months ended September 30, 2021, was $337,000, compared to $0 for the same period in 2020[23] - Net loss attributable to BeyondSpring Inc. for the three months ended September 30, 2021, was $18,370,000, compared to a net loss of $14,540,000 for the same period in 2020[23] - Comprehensive loss attributable to BeyondSpring Inc. for the nine months ended September 30, 2021, was $54,767,000, compared to $43,564,000 for the same period in 2020[23] - The net loss attributable to BeyondSpring Inc. for the nine months ended September 30, 2021, was $54,666, with a basic and diluted net loss per share of $(1.40)[104] Cash and Investments - As of September 30, 2021, the Company had cash, cash equivalents, and short-term investments totaling $91.6 million, sufficient to support ongoing clinical programs for the next year[10] - Cash and cash equivalents decreased from $109,537,000 at the beginning of the period to $63,434,000 by September 30, 2021[18] - As of September 30, 2021, the Company had $76,111 in net current assets and $91,600 in cash, cash equivalents, and short-term investments[36] - The fair value of the Series A-2 Preferred Shares was determined to be $5,267 at closing, with the fair value of the forward liability at $278[76] Expenses - R&D expenses for Q3 2021 were $8.5 million, slightly down from $8.6 million in Q3 2020, while G&A expenses increased to $10.2 million from $6.7 million in the same period[10] - Research and development expenses for the nine months ended September 30, 2021, were $31,102,000, compared to $33,369,000 for the same period in 2020[23] - Share-based compensation expenses for the nine months ended September 30, 2021, totaled $5,290, compared to $6,082 for the same period in 2020[110] - The total amounts for employee benefits expensed for the nine months ended September 30, 2021, were $212, up from $81 for the same period in 2020[102] Assets and Liabilities - Total current assets decreased from $113,400,000 as of December 31, 2020, to $94,668,000 as of September 30, 2021[18] - Total liabilities increased significantly from $25,217,000 as of December 31, 2020, to $59,208,000 as of September 30, 2021[18] - Total current liabilities increased from $3,806 as of December 31, 2020, to $5,768 as of September 30, 2021[108] - Total equity for BeyondSpring Inc. decreased from $88,340,000 as of December 31, 2020, to $38,331,000 as of September 30, 2021[19] Collaboration Agreements - Wanchunbulin received an upfront payment of approximately $30 million and could earn up to $170 million in milestone payments from Hengrui for plinabulin commercialization in Greater China[7] - Under the Hengrui Collaboration Agreement, Wanchunbulin received an upfront non-refundable fee of $31,039 (RMB200,000) in September 2021, with potential milestone payments of up to $108,638 (RMB700,000) and $62,079 (RMB400,000)[79] - The Company recognized collaboration revenue of $337 and $1,013 related to the Lilly Collaboration Agreement for the three and nine months ended September 30, 2021, respectively[77] Legal and Regulatory - The Company is not currently involved in any legal proceedings that would materially affect its business or financial condition[117] - Management does not believe there is substantial doubt about the Company's ability to continue as a going concern within one year after the date these financial statements are issued[37] Miscellaneous - The Company has primarily engaged in clinical stage biopharmaceutical activities focusing on the development of innovative cancer therapies[30] - The Company’s financial statements have been prepared in accordance with U.S. generally accepted accounting principles (U.S. GAAP) for interim financial information[33] - The Company has incurred operating losses and negative cash flows from operations since inception[36]