BeyondSpring Inc. (NASDAQ:BYSI) Q2 2019 Earnings Conference Call Transcript
Sep 18, 2019 • 08:00 am ET
majority of patients with high risk chemotherapy still develop grade three or four neutropenia, some over 90% after using Neulasta. Grade three or four neutropenia requires the chemotherapy dose be reduced, the next cycle be delayed, the chemo regime be downgraded or discontinued altogether. We call them the 4Ds. All of this results in significantly worse survival outcomes for patients. As a result, both indications present significant unmet medical need. Plinabulin has the potential to disrupt the current treatment landscape and greatly improve the overall patient outcome. Earlier this year, we reached the first pre-specified interim analysis of Study 103 for Plinabulin in the second and third line treatment for non-small cell lung cancer with EGFR wild type. After reviewing with the Data and the Safety Monitoring Board or DSMB on the safety and efficacy data, they recommend the trial to continue.
Last year, we generated extensive data suggesting Plinabulin's potential to meaningfully improve patient outcomes in CIN when combined with G-CSF. In Study 105 and 106, data generated indicates that Plinabulin significantly reduces bone pain, prevents thrombocytopenia, and reverses potential immune suppression of Neulasta. In addition, we generated data characterizing Plinabulin's unique mechanism action, supporting a differentiated product profile in the prevention of CIN, which appears to have a complementary therapeutic effect with G-CSF. We view Plinabulin as a pipeline in the drug. So far, Plinabulin had treated over 560 patients with good tolerability. The foundation stage is to the established Plinabulin as an anticancer and a CIN drug. We already had four clinical studies to confirm Plinabulin-CIN benefit and two clinical studies to show Plinabulin's anticancer benefit in non-small cell lung cancer.
The next stage is translation stage by combining Plinabulin with other chemo to treat additional cancer types. The transformation stage is to have triple combo of Plinabulin plus checkpoint inhibitors and chemo. This triple combo completes a perfect I/O cycle as chemo generates tumor antigen, Plinabulin induces DC maturation and activates tumor antigen specific T-cells and checkpoint inhibitors let T-cells kill cancer cells. We envision this triple combo could be as powerful as that of cocktail therapy for HIV.
Our regulatory strategy includes filing of NDAs for both non-small cell lung cancer and CIN in China in the first quarter of 2020 and in the US in 2020. In June this year, we had an End of Phase 2 meetings for CIN indication and aligned with the FDA that Study 105 and the 106 support a broad CIN label for all cancer and all chemo. We also continued to strengthen our robust intellectual property portfolio. Plinabulin's monohydrate composition is now allowed in China, in addition to the US. A new method of used patents for Plinabulin in treating brain tumor is recently issued, both patents are protected through 2036. The issuance of this patent further extends our proprietary rights and strengthens Plinabulin's global intellectual property position. We now have a total granted patent portfolio of 77 patents in 36 jurisdictions including 21 issued US patents with