BeyondSpring(US:BYSI)2022-04-14 17:06Financial Data and Key Metrics Changes - R&D expenses in Q4 2021 were $5.8 million, down from $8.4 million in the same period last year, a decrease of $2.6 million primarily due to lower clinical development expenses and personnel costs [14] - G&A expenses were $5.0 million in Q4 2021, compared to $10.4 million for the prior year, driven by lower share-based compensation expenses [14] - The net loss attributable to the company in Q4 2021 was $9.5 million, compared to $17.6 million for the same period last year [15] - For the full year 2021, R&D expenses were $36.9 million, down from $41.8 million in the prior year [15] - The net loss attributable to the company for the full year was $64.2 million, compared to $61.0 million for the prior year [16] - Cash balance at December 31, 2021, was $41.6 million, with short-term investments of $30.7 million, totaling $72.4 million [17] Business Line Data and Key Metrics Changes - The company is focused on the Plinabulin program, with ongoing discussions with the China NMPA regarding the review of Plinabulin NDA in combination with G-CSF for the prevention of chemotherapy-induced neutropenia (CIN) [4][5] - Positive top-line data from the Phase 3 DUBLIN-3 study for non-small cell lung cancer (NSCLC) was announced, showing significant improvement in overall survival rates [5][11] - The company is developing Plinabulin in immuno-oncology combinations for various cancers, targeting unmet medical needs [6] Market Data and Key Metrics Changes - The G-CSF market in China was valued at $1.2 billion in 2020, with around 30% annual growth since 2017 [4] - Hengrui Pharmaceuticals, a strategic partner, had $4.2 billion in sales in 2020, with $2.4 billion from oncology drug sales [7] Company Strategy and Development Direction - The company aims to bring Plinabulin to market, with patent protection extending to 2037 in 40 jurisdictions [8] - A strategic partnership with Hengrui Pharmaceuticals for the development and commercialization of Plinabulin in Greater China has been established [6][7] - The company is committed to continuing clinical and regulatory discussions in the U.S. while prioritizing NDA filing in China for NSCLC [12][13] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the potential approval of Plinabulin in China based on strong clinical data [20] - Discussions with the U.S. FDA regarding additional studies for CIN and NSCLC are ongoing, with a focus on the relevance of clinical data derived from Chinese populations [25][32] - The company remains committed to addressing unmet medical needs in cancer treatment through its innovative therapies [10][11] Other Important Information - The company is making progress in its subsidiary Seed Therapeutics, focusing on differentiated molecular glue technology [8] Q&A Session Summary Question: Update on China approval for CIN - The CIN NDA application is under independent review with the China NMPA, with positive meetings held [20] Question: Additional study for CIN in the U.S. - Active discussions with the U.S. FDA are ongoing regarding the design of the additional study [23] Question: Path forward for non-small cell lung cancer in the U.S. - Discussions with the U.S. FDA are ongoing, focusing on the relevance of the data derived from the Chinese population [25] Question: Role of Hengrui in regulatory filing in China - Hengrui is assisting in preparing answers for the NMPA review questions and attending meetings [45]