BeyondSpring(US:BYSI)2020-09-03 18:29Financial Data and Key Metrics Changes - R&D expenses in Q2 2020 were $11 million, up from $5.2 million in the same period last year, primarily due to a $4.9 million increase in clinical trial expenses [40] - SG&A expenses were $2.6 million in Q2 2020, compared to $2.1 million for the same quarter last year, mainly due to pre-launch preparation costs for Plinabulin [40] - Net loss attributable to BeyondSpring in Q2 2020 was $12.8 million, compared to $7.4 million for the same period last year [40] - Cash and cash equivalents at the end of Q2 were $38.1 million, sufficient to support clinical trials and NDA submissions [41] Business Line Data and Key Metrics Changes - The company is preparing for the NDA filing for Plinabulin for chemotherapy-induced neutropenia (CIN) by the end of 2020, with significant clinical data supporting its efficacy [8][10] - The PROTECTIVE-2 trial for CIN has completed enrollment ahead of schedule, with top-line data expected in Q4 2020 [10] - The DUBLIN-3 trial for non-small cell lung cancer (NSCLC) continues without modification based on favorable benefit-risk ratios [11][20] Market Data and Key Metrics Changes - The CIN market is significant, with over 1.3 million cycles of G-CSF administered annually, indicating a strong unmet need [29] - The NCCN guidelines have expanded prophylaxis to include both high and intermediate-risk patients, increasing the addressable market by over 100% [31] Company Strategy and Development Direction - BeyondSpring aims to transform into a commercial-stage company within the next 6 to 18 months through significant clinical and NDA catalysts [42] - The company is focusing on a triple combination strategy in oncology, which includes Plinabulin as a dendritic cell enhancer [24] - The company has initiated an Expanded Access Program (EAP) for Plinabulin to assist patients during the COVID-19 pandemic [25] Management's Comments on Operating Environment and Future Outlook - Management acknowledges that while COVID-19 has impacted timelines, the effect on ongoing trials is minimal, with expectations for data analysis in early 2021 [20][53] - The company is optimistic about the potential for Plinabulin to improve patient outcomes in oncology, particularly in combination with existing therapies [39] Other Important Information - The company has appointed Paul Friel as Chief Commercial Officer and Dr. Ravi Majeti to the Board of Directors, enhancing its leadership team [14][15] - Plinabulin's patent protections extend until 2036 in multiple jurisdictions, providing a substantial runway for commercialization [13] Q&A Session Summary Question: Can you discuss the NCCN guidelines submission prep for CIN? - The guidelines submission process is straightforward, and the next meeting is scheduled for mid-October [46][48] Question: Is it possible to get reimbursement for use ahead of official approval? - Payers will follow the label and NCCN guidelines, which will influence their reimbursement policies [50][51] Question: Can you provide more granularity on the timeline shifts related to COVID for non-small cell lung cancer? - COVID-19 has had minimal impact on timelines, with enrollment expected to finish this year [53] Question: What are the expectations for the CIN label? - Discussions with the FDA suggest a broad label for Plinabulin in combination with G-CSF across various cancers [55][56] Question: Any update on PROTECTIVE-1? - PROTECTIVE-1 has completed its interim analysis and is a supportive study for the combination label [64]