BYSI 万春医药 2019年第2季度财报电话会议文字稿中英文

Operator

各位好，欢迎参加BeyondSpring Inc 2019年第二季度财务业绩电话会议。我是Melissa，今天会议的操作员。请注意，今天的通话正在录音。现在，我将电话转交给今天的主持人，投资者关系部Stephen Kilmer。请开始。

Stephen Kilmer

谢谢主持人，也感谢各位参加今天的电话会议。我想提醒听众，今天通话中的发言可能包含前瞻性陈述，涉及BeyondSpring的临床和临床前研发活动及结果、监管和商业计划、行业趋势、市场潜力、合作倡议和财务预测等方面。这些陈述基于当前可获得的信息以及管理层对未来事件的当前假设、预期和预测。虽然管理层认为其假设、预期和预测在当前可获得信息的基础上是合理的，但提醒您不要过度依赖这些前瞻性陈述。公司的实际结果可能与本次通话中讨论的内容存在重大差异，原因包括公司20-F文件及其他向SEC提交文件中前瞻性陈述和风险因素部分描述的各种因素，这些文件可在BeyondSpring网站投资者关系部分获取。今天参加电话会议的有：董事长兼首席执行官黄岚博士，她将开始会议并提供简要概述；研发执行副总裁兼首席医疗官Ramon Mohanlal博士，他将提供临床更新；首席运营官Richard Daly，他将讨论BeyondSpring的市场营销和合作战略；以及首席财务官Edward Liu，他将提供财务更新。现在我很高兴将电话转交给黄博士。Lan？

Lan Huang

感谢Steve。感谢各位女士们、先生们今天参加电话会议。对于初次了解我们公司故事的朋友，BeyondSpring是一家全球临床阶段的生物制药公司，专注于开发和转化免疫肿瘤癌症疗法，以解决严重未满足的医疗需求。我们的核心资产、首创药物Plinabulin正在进行两项全球三期临床试验项目，一项作为直接抗癌药物治疗非小细胞肺癌，另一项用于预防化疗引起的中性粒细胞减少症（CIN）。自上次电话会议以来，我们持续生成新数据，这些数据展示了Plinabulin独特的研究设计和差异化特征，进一步支持其显著改善癌症治疗的潜力。在EGFR野生型二线和三线非小细胞肺癌治疗中（占西方患者的70%至85%），目前仅有四种获批疗法可用，中位总生存期获益有限，约为8至10个月，且存在严重中性粒细胞减少等特定严重不良事件。即使是PD-1抗体，其应答率也仅为20%左右，与标准治疗多西他赛相比，仅提供2.8个月的中位生存获益。在CIN方面，目前的预防标准是G-CSF，如Neulasta。然而，绝大多数接受高风险化疗的患者仍会出现3级或4级中性粒细胞减少，部分患者在使用Neulasta后发生率超过90%。3级或4级中性粒细胞减少需要降低化疗剂量、延迟下一周期治疗、降级化疗方案或完全停止治疗。我们称之为"4D"。所有这些都导致患者的生存结果显著恶化。因此，这两个适应症都存在显著的未满足医疗需求。Plinabulin有潜力改变当前的治疗格局，并极大改善患者的总体预后。今年早些时候，我们完成了Plinabulin在EGFR野生型二线和三线非小细胞肺癌治疗中的103研究的首次预设中期分析。在与数据和安全监测委员会（DSMB）审查安全性和有效性数据后，他们建议试验继续进行。去年，我们生成了大量数据，表明Plinabulin与G-CSF联合使用时，有潜力显著改善CIN患者的预后。在105和106研究中，生成的数据表明Plinabulin显著减轻骨痛、预防血小板减少症，并逆转Neulasta潜在的免疫抑制作用。此外，我们还生成了描述Plinabulin独特作用机制的数据，支持其在预防CIN方面的差异化产品特征，这似乎与G-CSF具有互补的治疗效果。我们将Plinabulin视为药物中的管线。迄今为止，Plinabulin已治疗超过560名患者，耐受性良好。基础阶段是确立Plinabulin作为抗癌和CIN药物。我们已有四项临床研究证实Plinabulin的CIN获益，以及两项临床研究显示Plinabulin在非小细胞肺癌中的抗癌获益。下一阶段是转化阶段，通过将Plinabulin与其他化疗药物联合治疗更多癌症类型。转型阶段是实现Plinabulin加检查点抑制剂和化疗的三联组合。这种三联组合完成了完美的免疫肿瘤循环：化疗产生肿瘤抗原，Plinabulin诱导树突状细胞成熟并激活肿瘤抗原特异性T细胞，检查点抑制剂让T细胞杀死癌细胞。我们设想这种三联组合可能像HIV鸡尾酒疗法一样强大。我们的监管策略包括在2020年第一季度在中国提交非小细胞肺癌和CIN的新药申请，并在2020年在美国提交。今年6月，我们为CIN适应症举行了二期结束会议，并与FDA达成一致，认为105和106研究支持广泛的CIN标签，适用于所有癌症和所有化疗方案。我们还继续加强我们强大的知识产权组合。Plinabulin的一水合物组合物现已在中国获得批准，此前已在美国获批。最近还发布了Plinabulin治疗脑肿瘤的新使用方法专利。这两项专利的保护期均至2036年。该专利的发布进一步扩展了我们的专有权，并加强了Plinabulin的全球知识产权地位。我们现在在36个司法管辖区拥有总共77项授权专利组合，包括21项美国专利，保护期至2036年。最近几个月，我们通过多次股权融资加强了资产负债表。这些融资所得将支持我们的临床和临床前开发，并使我们能够顺利实现计划的监管里程碑。此外，我们在推进三种临床前免疫药物BPI-002、BPI-003和BPI-004以及使用泛素介导降解途径的研究平台方面也进展顺利。现在我将电话转给Ramon，他将更详细地讨论我们最近的临床发展。Ramon？

Lan Huang

Thank you, Steve. Thank you for joining the call today, ladies and gentlemen. For those of you who are new to our story, BeyondSpring is a global, clinical-stage biopharmaceutical company focused on developing and transforming immunooncology cancer therapies to address severely unmet medical needs. Our lead asset, a first-in-class asset, Plinabulin is in two Phase 3 global clinical programs, one as a direct anticancer agent in the treatment of non-small cell lung cancer and the other in the prevention of chemotherapy-induced neutropenia or CIN. Since our last call, we continued to generate new data that characterize Plinabulin's unique study design and differentiated profile that further supports its potential to significantly improve cancer care. In second and third line non-small cell lung cancer with EGFR wild type, which accounts for 70% to 85% of Western patients, there are currently only four approved therapies available with limited survival benefit at around 8 to 10 months median overall survival, and certain SAEs such as severe neutropenia. Even PD-1 antibody’s response rate is around 20% and only has 2.8 months median survival benefit compared to docetaxel, the standard of care in this patient population. In CIN, the current standard of prevention care is G-CSF, such as Neulasta. However, the vast majority of patients with high-risk chemotherapy still develop grade 3 or 4 neutropenia, some over 90% after using Neulasta. Grade 3 or 4 neutropenia requires the chemotherapy dose be reduced, the next cycle be delayed, the chemo regime be downgraded, or discontinued altogether. We call them the 4 Ds. 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 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 of 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 established Plinabulin as an anticancer and CIN drug. We already had four clinical studies to confirm Plinabulin’s 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 antigens, 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 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 protection until 2036. In recent months, we strengthened our balance sheet through a number of equity financings. The proceeds from these financing are to support our clinical and pre-clinical development, and well position us to achieve the planned regulatory milestones. In addition, we are also well on track in advancing three preclinical immune agents, BPI-002, BPI-003, and BPI-004 and a research platform using ubiquitin-mediated degradation pathway. I will now turn the call to Ramon, who will discuss our recent clinical development in more detail. Ramon?

Ramon Mohanlal

谢谢，Lan。首先，我想提供我们主要资产Plinabulin注册试验的最新进展。研究103是一项554名患者的3期注册研究，评估Plinabulin联合多西他赛对比单用多西他赛在二线及三线非小细胞肺癌中的抗癌效果，主要终点为中位总生存期。截至目前，我们已在美国、澳大利亚和中国招募了约450名患者。该研究设有两个预设的中期分析：第一个在三分之一患者死亡事件时进行；第二个在三分之二患者死亡事件时进行。今年早些时候，我们达到了第一个中期分析点，数据安全监测委员会建议试验继续。第二次中期分析预计在2019年第四季度或2020年第一季度进行。如果中位总生存期的p值在第二次中期分析中小于或等于0.012，试验可能提前终止。如果p值大于0.012，试验将继续进行，预计在439名患者死亡事件时的最终结果将于2020年公布。如果最终结果的中位总生存期p值小于或等于0.046，该研究可被认定为成功。该研究在靶向人群选择方面的创新设计已于上周在国际肺癌研究协会世界肺癌大会上展示。研究105和研究106评估Plinabulin在预防化疗诱导的中性粒细胞减少症方面的效果。研究105是一项2/3期注册试验，在美国、中国、俄罗斯和乌克兰评估Plinabulin在晚期乳腺癌、激素难治性前列腺癌和晚期非小细胞肺癌患者中，在标准多西他赛方案后的应用。该试验的主要终点是与标准治疗Neulasta相比，第一个化疗周期中严重中性粒细胞减少症持续时间。该试验2期部分的前期数据已表明，在化疗当天单次给药的Plinabulin与Neulasta同样有效，且具有显著减少骨痛的益处，提供优于Neulasta的免疫特征，有潜力减轻血小板减少症，同时其独特的作用机制可能使其与Neulasta在预防CIN方面具有互补性。2018年12月，我们在预设的中期分析中宣布，研究105的3期部分达到了其主要终点，即Plinabulin 40毫克固定剂量与Neulasta 6毫克在第一个周期严重中性粒细胞减少症持续时间方面的非劣效性。这一结果在美国国家综合癌症网络中性粒细胞减少症管理指南主席Crawford博士主持的DSMB会议上得到确认。这些数据结合2期数据表明，Plinabulin具有优越的产品特征，使我们能够在2020年第一季度在中国提交Plinabulin用于CIN的新药申请，随后于2020年在美国提交，并辅以研究1063期部分的额外数据。研究106评估Plinabulin联合Neulasta对比单用Neulasta在预防接受TAC化疗（即乳腺癌患者中多西他赛、多柔比星和环磷酰胺的三联组合）患者CIN和骨痛方面的效果。该试验2期部分的先前顶线数据表明，在治疗CIN方面有显著疗效改善，经历3级或4级CIN的患者比例显著降低，经历骨痛的患者减少90%以上，并且在标准治疗基础上加用Plinabulin可降低免疫抑制表型的可能性。研究106的3期部分旨在双盲研究中比较Plinabulin 40毫克固定剂量联合Neulasta 6毫克与单用Neulasta 6毫克。该研究的主要终点是显示第一个周期严重中性粒细胞减少症持续时间的优效性。综合来看，这些数据表明Plinabulin为预防接受化疗患者的CIN和骨痛提供了一种新方法。更少的中性粒细胞减少和骨痛将使更多患者能够接受全剂量化疗并完成整个化疗疗程，这意味着加用Plinabulin可能显著改善当前的CIN标准治疗并产生更好的患者结局。自我们上次电话会议以来，我们报告了支持Plinabulin有利药物特征的额外数据。2019年5月，BeyondSpring宣布基于研究1062期部分数据的两篇摘要被2019年ASCO年会议程收录发表。第一篇摘要得出结论，在标准剂量Neulasta基础上加用Plinabulin在整个高风险TAC周期中提供了更优的CIN保护。这种程度的CIN保护不仅在使用这两种药物之一时无法实现，而且加用Plinabulin还能消除骨痛，而单用Neulasta则不能。第二篇摘要得出结论，半剂量Neulasta联合Plinabulin对CIN的疗效与全剂量Neulasta单药相当，显示出强大的中性粒细胞减少益处。联合治疗还为患者提供了显著更低的骨痛水平以及与单用Neulasta相比更有利的免疫特征。这些数据表明，Plinabulin-Neulasta联合方案带来了单用Neulasta所没有的额外益处，为使用这种联合方案更有效地治疗CIN提供了额外依据。同样在5月，在国际药物经济学与结果研究学会2019年会议上，BeyondSpring CIN开发项目的全球主要研究者、斯坦福大学医学中心医学教授Douglas Blayney博士展示了基于研究1052期部分的数据。数据表明，Plinabulin在减少多西他赛诱导的中性粒细胞减少方面与Neulasta具有相似的疗效特征，但Plinabulin显著减少了患者报告的骨痛。最近，我们宣布了一项头对头临床试验的结果，该试验评估了在研究105中接受多西他赛治疗并使用Plinabulin或Neulasta预防中性粒细胞减少的晚期非小细胞肺癌患者的生活质量。结果表明，在四个治疗周期中，Plinabulin显著改善了生活质量。此外，在疲劳、疼痛和失眠方面，患者的生活质量有显著改善。这强化了Plinabulin作为与Neulasta在预防CIN方面同样有效但具有更优副作用特征的药物形象，部分归因于其显著减少骨痛，从而改善患者生活质量。在此，我将把电话转给Rich，他将讨论我们的营销和合作策略。Rich？

Ramon Mohanlal

Thanks, Lan. First, I would like to provide an update on our registrational trials for our lead asset, Plinabulin. Study 103 is a 554-patient, Phase 3 registrational study evaluating the anticancer effects of Plinabulin in combination with docetaxel compared to docetaxel alone in the second and third line non-small cell lung cancer with its primary endpoint of median overall survival. To date, we have enrolled approximately 450 patients in the US, Australia, and China. The study has two pre-specified interim analysis; the first, at one-third of patient death events; and the second, at two-thirds of patient death event. Earlier this year, we reached the first interim analysis, and DSMB recommended the trial to continue. The second interim analysis is expected in the fourth quarter of 2019 or the first quarter of 2020. If the p-value for the median overall survival and the second interim analysis is less or equal to 0.012, the trial may stop early. If the p-value is greater than 0.012, the trial will continue and final results of the trial at a death event of 439 patients are expected to be available in 2020. If the p-value for median overall survival for the final result is less than or equal to 0.046, the study can be claimed successful. The study's novel design in targeted population selection was presented at the IASLC World Conference on Lung Cancer last week. Study 105 and Study 106 evaluate Plinabulin's effect in the prevention of chemo-induced neutropenia. Study 105 is a Phase 2, 3 registrational trial of Plinabulin, after the standard regimen of docetaxel in advanced breast cancer, hormone refractory prostate cancer and advanced non-small cell lung cancer patients in the US, China, Russia and the Ukraine. The primary endpoint of this trial is duration of severe neutropenia or DSM in the first cycle of chemotherapy compared to the standard of care, Neulasta. Previous data from the Phase 2 portion of this trial already demonstrated that Plinabulin given as a single dose cycle on the same day of chemotherapy would be as effective as Neulasta with the benefit of causing much less bone pain, offering a superior immune profile compared with Neulasta, having the potential to mitigate thrombocytopenia while its unique mechanism of action potentially makes it complementary to Neulasta in preventing CIN. In December 2018, we announced in a pre-specified interim analysis the Phase 3 portion of Study 105 met its primary endpoint of non-inferiority of Plinabulin 40 milligram fixed dose versus Neulasta 6 milligram for DSM of the first cycle. This was confirmed at the DSMB meeting chaired by Dr. Crawford, Chairman of the NCCN, Guidelines for Neutropenia Management in the US. This data combined with Phase 2 data suggests that Plinabulin has a superior product profile and well positions us to file NDAs for Plinabulin for CIN in China in the first quarter of 2020 followed by the US in 2020 with additional data from the Phase 3 portion of Study 106. Study 106 evaluates the combination of Plinabulin with Neulasta versus Neulasta alone to prevent CIN and bone pain in patients receiving TAC chemotherapy, which is the triple combination of taxotere, doxorubicin and cyclophosphamide in breast cancer patients. Previous topline data from the Phase 2 portion of this trial suggests a significant improvement in efficacy in treating CIN, a significant decrease in the percentage of patients experiencing grade 3 or 4 CIN, more than 90% reduction in patients experiencing bone pain and reduced potential for immune-suppressive phenotype when adding Plinabulin to the standard of care. The Phase 3 portion of Study 106 is to compare Plinabulin at 40 milligram fixed dose combined with 6 milligram Neulasta versus 6 milligram Neulasta alone in a double-blind study. The aim of the study is to show superiority in DSM in the first cycle as a primary endpoint. Together, this data suggest that Plinabulin offers a new approach to preventing CIN and bone pain in patients receiving chemotherapy. Less neutropenia and bone pain would enable more patients to receive a full dose of chemotherapy and complete their full chemo course, meaning that the addition of Plinabulin may meaningfully improve the current CIN standard of care and generate better patient outcomes. Since our last call, we reported additional data supporting Plinabulin favorable drug profile. In May 2019, BeyondSpring announced the two abstracts based on data derived from the Phase 2 portion of Study 106 were accepted for publications in the proceedings of the 2019 ASCO Annual Meeting. The first abstract concluded that adding Plinabulin to the standard dose of Neulasta offered superior CIN protection throughout the entire high risk TAC cycle. Not only is this degree of CIN protection unachievable when using just one of these two agents, with the addition of Plinabulin also eradicated bone pain compared to Neulasta alone. The second abstract concluded that a half dose of Neulasta combined with Plinabulin is equally effective against CIN as a full dose of Neulasta alone demonstrating a strong neutropenia benefit. The combination therapy also offered significantly lower levels of bone pain for patients as well as favorable immune profile compared to Neulasta alone. This data suggest that the Plinabulin-Neulasta combination creates added benefits that are not seen with Neulasta alone, providing additional rationale for the use of this combination to more effectively treat CIN. Also in May, at the International Society for Pharmacoeconomics and Outcomes Research 2019 Conference, Dr. Douglas Blayney, global Principal Investigator for BeyondSpring's CIN development program and Professor of Medicine at Stanford University Medical Center presented data derived from the Phase 2 portion of Study 105. The data demonstrated that Plinabulin has a similar efficacy profile as Neulasta in reducing docetaxel induced neutropenia, however Plinabulin significantly reduced patients report to bone pain. More recently, we announced results of a head to head clinical trial assessing quality of life in advanced non-small cell lung cancer patients being treated with docetaxel and either Plinabulin or Neulasta for the prevention of neutropenia in Study 105. It demonstrated that Plinabulin significantly improved quality of life over four cycles of treatment. Moreover, there were significant improvements in patients quality of life in terms of fatigue, pain and insomnia. This strengthens Plinabulin's profile as an agent that is as effective as Neulasta at preventing CIN between the superior side-effect profile that improves patient quality of life, in part because of its significant reduction in bone pain. With that, I'll turn the call to Rich, who will discuss our marketing and partnering strategy. Rich?

Richard Daly

谢谢Ramon。我们最新的数据发布继续支持差异化的产品特性，我们相信Plinabulin能够改善标准治疗，并对癌症患者、需要预防中性粒细胞减少症的患者以及寻求非小细胞肺癌治疗选择的患者的生活产生积极影响，我们继续推动组织向商业化迈进。今天上午，我将阐述我们商业化前景的三个组成部分：CIN机会、不断演变的非小细胞肺癌市场以及支持我们临床团队出色工作的业务发展战略。首先，CIN机会。目前全球每年使用400万周期的单药G-CSF来预防CIN。今年5月，Wilson及其同事在《柳叶刀》上发表了一项研究，预测到2040年肿瘤学和化疗方案的增长。Wilson表示，他们预计全球癌症诊断将从1700万例增长到超过2600万例。此外，首次化疗周期数在此期间将增长53%，从980万增加到超过1500万。因此，我们预计像Plinabulin这样的支持性治疗药物将参与这一增长。正如Lan早些时候指出的，有机会改善标准治疗并改善患者预后。Lan和Ramon都提到的临床特征清楚地表明了在预防CIN方面的优越性，以及提高化疗方案依从性和持续性的潜力，希望预后能得到改善。我们的市场研究表明，有机会将Plinabulin打造成一种能够通过维持剂量强度和保持患者按计划剂量间隔治疗来改善标准治疗的疗法。这些是癌症治疗的关键成功因素。即使是剂量的微小变化或输注的短暂延迟，都可能对总生存期产生不利影响。事实上，化疗剂量减少15%可能导致长期总生存期减少50%，这是一个毁灭性的结果。我们的专有市场研究表明，肿瘤学家对Plinabulin的产品特性反应非常积极。此外，医生们很快理解了Plinabulin和G-CSF互补作用机制的逻辑。Plinabulin的起效速度与G-CSF的延迟起效相比至关重要。此外，与G-CSF联合使用时，优越的绝对中性粒细胞计数也是一个优势，而骨痛的减轻也是一个好处。因此，肿瘤学家理解了Plinabulin加G-CSF组合的合理性，既为了即时的临床效果，也为了保持患者按计划的化疗方案、剂量和周期时间的潜在长期益处。中性粒细胞减少症是化疗方案改变的首要原因，而Plinabulin加G-CSF的组合显示出巨大前景，并[听不清]肿瘤学家和患者坚持个体化治疗计划，避免Lan早些时候提到的4D。我们的目标不仅仅是预防中性粒细胞减少症和骨痛。我们将Plinabulin的临床益处视为医疗提供者可能产生更好化疗结果的工具，即为临床医生提供机会为患者选择最合适、最积极的治疗，并相信Plinabulin加G-CSF的预防性治疗可以显著减少中性粒细胞减少症，患者可以继续接受靶向化疗。迄今为止，由Mohanlal博士领导的BeyondSpring临床团队生成的数据不仅支持这一观点，还为Plinabulin在非小细胞肺癌和仅化疗方案中预防CIN之外的潜在生命周期管理机会提供了引人入胜的见解。我们持续的数据生成继续给我们信心，即Plinabulin加G-CSF的联合治疗可以成为预防中性粒细胞减少症的新标准治疗。此外，我们认为市场动态，如化疗的增长和联合方法的成功，Plinabulin加G-CSF，使CIN成为一个增长机会。最后，最近生物类似物在CIN领域的成功完全支持我们的策略，由于生物类似物G-CSF的成功增加了选择并改善了成本状况，联合方法有可能对提供者和支付方更具吸引力。Plinabulin的定位很明确。Plinabulin与G-CSF联合使用，建立并改善了预防CIN的标准治疗。我们的第二个主题是非小细胞肺癌。这一治疗领域继续快速发展。最近PD1和PDL1与化疗联合治疗的批准表明了化疗在癌症治疗中的长期重要性。I/O治疗的进展为BeyondSpring和Plinabulin带来了许多机会。首先，正如我之前提到的一线治疗，我们预计像Plinabulin这样的产品将有更多机会。正如Lan在她早先的评论中提到的，非小细胞肺癌的二线和三线治疗选择并不理想，Plinabulin可能为这些患者带来重大进展。其次，我们与I/O化合物联合的早期工作可能显示出超越目前单独使用I/O所见的益处。这可能代表一个额外的重大增长机会，帮助患者和提供者应对这种毁灭性疾病。第三，如前所述，研究表明，作为癌症治疗支柱的化疗预计将在中长期内增长。这种增长的大部分是由与新型I/O疗法的联合使用推动的。如前所述，这些化疗很可能导致CIN。迄今为止生成的Plinabulin免疫学数据表明，与G-CSF不同，Plinabulin不会引起免疫抑制。在这种治疗范式中，Plinabulin可能是I/O疗法的理想伙伴。最后，随着检查点抑制剂的持久反应，我们预计I/O化疗周期将显著扩大，从而增加了对像Plinabulin这样的产品的需求，以保护患者免受CIN影响。最后，我们的第三个主题，业务发展。我们相信Plinabulin作为CIN和非小细胞肺癌直接抗癌疗法都具有巨大潜力。迄今为止从我们的临床项目中生成的数据支持这一观点。Plinabulin提供了一种差异化的作用机制，得到临床数据的支持，并有可能对癌症患者的护理产生积极影响。当前CIN和非小细胞肺癌的市场规模、这两个市场中未满足的医疗需求以及Plinabulin的特性，使Plinabulin成为与成熟制药合作伙伴感兴趣的资产。我们的业务发展战略是利用Plinabulin为患者、提供者、支付方和股东创造最大价值。虽然美国境外的癌症病例数超过境内，但大部分商业价值在美国境内。因此，我们寻求能够使BeyondSpring在美国保留最大价值的合作伙伴，同时使我们能够利用合作伙伴的基础设施在海外推出。我们寻求能够在美国以外自行商业化Plinabulin的合作伙伴，同时我们保留在美国的CIN和非小细胞肺癌的重要权利。我们正在积极与多个潜在合作伙伴进行后期讨论，这些合作伙伴与我们的战略一致。我们期待在未来向您更新我们的进展。说到这里，我将把电话转给Edward，他将提供财务更新。Edward？

Richard Daly

Thanks Ramon. Our most recent data releases continue to support a differentiated product profile and we believe that Plinabulin can improve the standard of care and positively affect the lives of patients with cancer, those who require prevention of neutropenia and those seeking options for the treatment of non-small cell lung cancer and we continue to advance the organization toward commercialization. This morning, I'll be addressing three components of our commercialization prospects; the CIN opportunity, the evolving non-small cell lung cancer market and our business development strategy that supports the excellent work of our clinical team. First, the CIN opportunity. 4 million cycles of monotherapy G-CSF are used worldwide each year to prevent CIN today. In May of this year, Wilson and colleagues published a study in the Lancet forecasting the growth of oncology and chemotherapy regimens through 2040. Wilson stated that they expected cancer diagnoses to grow from 17 million cases worldwide to over 26 million. Additionally, the number of first course chemotherapy cycles will grow by 53% over this time from 9.8 million to over 15 million. As a result, we expect the use of supportive care therapies like Plinabulin to participate in this growth. As Lan noted earlier, there is an opportunity to improve on the standard of care and improve the outcome for patients. The clinical profile that both Lan and Ramon referred to presents a clear case for superiority in the prevention of CIN and the potential for increasing compliance and persistency with chemotherapeutic regimens with the hope that outcomes will be improved. Our market research demonstrates the opportunity to build the case for Plinabulin as a therapy that can improve the standard of care through maintaining dose intensity and keeping patients on their scheduled dose intervals. These are critical success factors in the treatment of cancer. Even small changes in dosing or brief delays in infusions can add detrimental effects on overall survival. In fact, a 15% reduction in chemo doses can result in a 50% reduction in long-term overall survival, a devastating result. Our proprietary market research indicates that oncologists have a very favorable response to Plinabulin's product profile. Also, physicians quickly grasp the logic of the complementary MOAs of both Plinabulin and G-CSF. The speed of onset of Plinabulin versus the delayed onset of G-CSF is critical. Additionally, the superior absolute neutrophil count is also a benefit when combined with G-CSF and then the reduction in bone pain is also a benefit. As a result, the oncologists understood the rationale for the Plinabulin plus G-CSF combination for the immediate clinical as well as the potential long-term benefits of keeping patients on planned chemotherapy regimen, dosing and cycle timing. Neutropenia is the number one cause of changes in chemotherapy regimens and the combination of Plinabulin Plus G-CSF shows great promise and [indiscernible] oncologist and the patient to stick to the individualized treatment plan and avoid the 4Ds that Lan mentioned earlier. Our goals go beyond preventing neutropenia and bone pain. We see Plinabulin's clinical benefit as a tool for providers to potentially generate better chemotherapeutic outcomes, that is, provide the clinician with the opportunity to choose the most appropriate, most aggressive therapy for the patients and have the confidence that prophylaxis with Plinabulin plus G-CSF, neutropenia can be significantly reduced and patients can remain on their targeted chemotherapy. The data generated to-date by the BeyondSpring clinical team under Dr.Mohanlal's leadership has produced data that supports not only this view, but also provides intriguing insight into the potential life-cycle management opportunities for the use of Plinabulin beyond non-small cell lung cancer and the prevention of CIN in chemotherapy only regimens. Our ongoing data generation continues to give us confidence that combination therapy that is Plinabulin plus G-CSF can become the new standard of care for prophylaxis of neutropenia. Additionally, we believe that market dynamics such as the growth of chemotherapy and success of the combination approach, Plinabulin plus G-CSF that CIN is a growth opportunity. Finally, the recent success of biosimilars in the CIN space fully supports our strategy with increased choice and improved cost profile due to the biosimilar G-CSF success, the combination approach has the potential to become even more attractive to providers and payers. Plinabulin's position is straightforward. Plinabulin combined with G-CSF builds on and improves standard of care for the prevention of CIN. Our second topic is non-small cell lung cancer. This therapeutic area continues to evolve rapidly. The recent advancements in care with the approval of PD1s and PDL1s in combination with chemotherapy are indicative as the long-term importance of chemotherapy in the treatment of cancer. The advancement of I/O therapy represents a number of opportunities for BeyondSpring and Plinabulin. First, as I alluded first line therapy, we expect to see greater opportunities for products like Plinabulin. As Lan mentioned in her early remarks, the options were second and third line non-small cell lung cancer are not ideal and Plinabulin could represent a significant advancement for these patients. Second, our early work in combination with I/O compounds may demonstrate benefits over and above that, which currently you have seen with I/O alone. This may represent an additional significant growth opportunity to help patients and providers struggling to address this devastating disease. Third, as mentioned earlier, studies indicate that chemotherapy, a mainstay of cancer treatment is expected to grow in the mid to long-term. Much of this increase in volume has been driven by the combination with newer I/O therapies. As discussed earlier, these chemotherapy will likely give rise to CIN. Plinabulin's immunologic data generated to-date demonstrates that Plinabulin unlike G-CSF does not cause immune suppression. In this therapeutic paradigm, Plinabulin could be the ideal partner for I/O therapies. Finally, with a durable response of checkpoint inhibitors, we expect I/O chemotherapy cycles to be significantly expanded, thus creating an increased need for products like Plinabulin to be used to protect patients from CIN. Finally, our third topic, business development. We believe Plinabulin has tremendous potential, both as a CIN and non-small cell cancer direct anticancer therapy. The data generated from our clinical programs to-date support this view. Plinabulin offers a differentiated mechanism of action, it is supported by clinical data and has the potential to positively affect the care of patients suffering with cancer. The current market size for both CIN and non-small cell lung cancer, the unmet medical needs in both of these markets and the Plinabulin profile have positioned Plinabulin as an asset of interest with well-established pharma partners. Our business development strategy is to leverage Plinabulin to create the greatest value for patients, providers, payers and shareholders. While the number of cancer cases outside the US exceeds those within the borders, the majority of commercial value resides within the US. Consequently, we seek partners that will enable BeyondSpring to retain the greatest value here in the US, while enabling us to leverage partner infrastructure to launch abroad. We seek partners who can commercialize Plinabulin outside the US on their own, while we retain significant rights to CIN and non-small cell lung cancer in US. We are actively engaged in multiple late stage discussions with potential partners who are aligned with our strategy. We look forward to updating you in the future on our progress. With that, I'll turn the call over to Edward, who will provide a financial update. Edward?

Edward Liu

谢谢，Rich。现在我将简要讨论我们2019年第二季度的财务业绩。有关这些业绩的更多详细信息，请参阅我们今天早上发布的新闻稿和我们的6-K文件，两者均可在我们的网站上查阅。接下来，我将重点介绍一些关键数字。2019年第二季度的研发费用为520万美元，而去年同期为1100万美元。减少的580万美元主要归因于：与临床试验相关的CRO费用及其他服务费减少390万美元，制造费用减少110万美元，以及非现金股份薪酬减少80万美元。2019年第二季度的行政及管理费用为210万美元，而2018年同期为140万美元。增加的主要原因是非现金股份薪酬。2019年第二季度归属于BeyondSpring的净亏损为740万美元，而去年同期为1220万美元。截至2019年6月30日的现金余额为70万美元。近几个月来，我们通过多项股权融资交易加强了资产负债表。7月19日，我们完成了由德诚资本领投的3500万美元公开发行。该交易吸引了来自美国高质量投资者的强劲需求，并获得超额认购。6月和7月，我们的中国子公司与以亿方资本为首的特定投资者签订了一系列股权购买协议，以约1亿元人民币（合1450万美元）收购中国子公司4.76%的股权。截至目前，我们已收到约1000万美元。5月，我们设立了ATM融资机制，并在7月因预期上述公开发行而暂停前筹集了约3000万美元。我们相信，包括这些融资净收益在内的现金资源足以支持我们的临床试验，在中国提交Plinabulin用于治疗CIN和非小细胞肺癌的新药申请，并推进我们的免疫肿瘤学管线以及泛素化蛋白降解研究平台。现在，我将把电话交还给Lan。Lan？

Edward Liu

Thanks, Rich. I'll now briefly discuss our second quarter 2019 financial results. For greater details related to these results, I'll refer you to our press release issued this morning and our 6-K filing, both of which can be accessed on our website. With that said, I'll just highlight some key numbers. R&D expenses in the second quarter of 2019 were $5.2 million compared to $11 million in the same period last year. The decrease of $5.8 million was largely attributable to a $3.9 million decrease in expenses incurred by CROs and other service fees related to clinical trials, a $1.1 million decrease in manufacturing expenses and a $0.8 million decrease in non-cash share-based compensation. G&A expenses were $2.1 million in the second quarter of 2019 compared to $1.4 million for the same quarter of 2018. The increase was mainly due to non-cash share-based compensation. Net loss attributable to BeyondSpring in the second quarter of 2019 was $7.4 million compared to $12.2 million for the same period last year. Cash balance on June 30th 2019 were $0.7 million. In recent months, we have strengthened our balance sheet through a number of equity financing transactions. On July the 19th, we closed a $35 million public offering led by Decheng Capital. The transaction attracted strong demand from high quality US-based investors and was highly oversubscribed [ph]. In June and July, our China subsidiary entered into a series of equity purchase agreements with certain investors led by Efung Capital to acquire a 4.76% stake in the China subsidiary for approximately RMB100 million or $14.5 million. We have so far received approximately $10 million. In May, we put in place an ATM facility and raised approximately $30 million before it was suspended in July in anticipation of the aforementioned public offering. We believe our cash resources, including the net proceeds from these financings are sufficient to support our clinical trials and submit NDA in China for Plinabulin for the treatment of CIN and non-small cell lung cancer and to advance our immuno-oncology pipeline as well as our ubiquitination protein degradation research platform. With that, I'll now turn the call back to Lan. Lan?

Lan Huang

谢谢，Edward。我们对临床开发进展以及迄今为止所展现的一致性感到非常满意，这进一步支持了Plinabulin改善癌症治疗的有利药物特性。展望未来，我们预计在未来12到18个月内将迎来许多重要的数据和监管里程碑，这将使我们从临床阶段公司转变为商业化阶段公司。与我们的股东、投资者和合作伙伴一起，我们正在努力继续创造价值，并为有需要的患者提供创新药物。我期待在未来几个月内就我们实现这一目标的进展向大家汇报。我们将公司命名为BeyondSpring有两层含义。首先是超越国界，我们整合美国和中国资源，以实现时间和成本效益，并瞄准这两个全球最大的医药市场。这种独特且可扩展的商业模式将为我们的股东带来最大回报。其次是超越季节。我们希望从播种整个春季直接进入NDA的收获季节。正如大家所知，收获季节或秋天即将到来。今天的电话会议到此结束。感谢大家的参与。

Operator

谢谢。现在我们将进行问答环节。[接线员指示] 我们的第一个问题来自William Blair的Andy Hsieh。请提问。

Andy Hsieh

谢谢您回答我的问题，祝贺Lan和BeyondSpring团队取得的所有进展。我有几个问题。Lan，您提到了一些临床前资产，基本上是002、003和004。您能否提供更多信息，这些是来自泛素化类别还是更类似于Plinabulin的后续资产？

Lan Huang

好的。谢谢Andy对我们管线的提问。实际上，002、003和004是免疫相关的临床前资产。我会让Ramon更详细地介绍一下，但除此之外，我们确实拥有泛素化和降解平台，该平台正处于非常先进的开发阶段，我们的第一个靶点是KRAS，这是圣杯靶点。所以，我让Ramon来回答关于临床前资产的问题。

Ramon Mohanlal

是的。002、003和004资产是免疫增强剂。它们是小分子药物。所以这是小分子药物而非生物制剂。002类似于CTLA-4共刺激剂，003是信号通路调节剂，004是一种能够在通常不表达足够抗原以刺激免疫系统的癌症中诱导新抗原的药物。

Andy Hsieh

好的。明白了。我只是想澄清这个事实。所以，我还想确认一下我的理解。您提到了第一次中期分析。我相信，第一次中期分析基本上是关于阈值的问题，即风险比阈值为0.75。如果高于这个阈值，那么研究设计就会增加入组人数以获取研究的完整统计功效。那么，是否可以正确假设，至少在33%的人群中，您观察到的风险比为0.75或更低？这是否是对研究[ph]的正确假设？

Lan Huang

是的。是的，因为——所以，研究设计没有变化，样本量没有增加，所以这是风险比等于或小于0.75的估计。

Andy Hsieh

好的。明白了。然后关于中国的国家医保目录评审，我相信这是每两年进行一次的。所以，今年会稍微晚一些。那么，明年提交国家医保目录评审申请时，是针对2021年的周期还是2020年的周期？我只是想了解一下评审的季节性规律？

Lan Huang

是的。实际上，在中国，以前是每八年进行一次国家医保评估。但现在，实际上他们增加了对国家医保资产评审的频率，甚至可能超过每两年一次。我们看到像泰瑞沙这样的药物以及其他实际上非常——国家像中国开发其资产，也在获批后很快进入国家医保。所以我预计，如果我们有幸在2020年或2021年获得该药物批准，我们应该能够在获批后立即开始与政府进行谈判。

Andy Hsieh

我明白了。好的。我想我还有一个关于生物类似药影响的问题要问Rich。安进有Onpro，它提高了便利性。那么随着生物类似药重新进入市场，您是否认为便利性因素会变得更差，因为接受生物类似药治疗的患者可能需要回来接受注射。您认为这是否为BeyondSpring提供了一个机会，在市场上提供更便利的产品？

Richard Daly

所以，我认为这是一个非常好的问题。我认为在G-CSF领域，无论是生物类似药还是创新药，这正在成为一个价格敏感的市场，因为没有增量创新。普那布林带来的价值是与G-CSF联合使用的增量创新。因此，回到你的观点，我们看到Coherus取得了巨大成功。他们在最近的公告中预测，最终将获得20%的市场份额。我们看到安进的份额略有下降，价格显著下降，显然是因为生物类似药正在抢占市场份额。但对我们来说，由于我们是30分钟输注，化疗后30分钟在化疗当天进行，我们认为这是一个相当显著的进步和便利。但我们所做的市场调研显示，Andy，医生们对患者护理标准的改善感到非常兴奋。所以，我们看到即使是使用Onpro，如果你看看安进与IQVIA合作生成的一些数据，他们进行了20万周期的研究。即便如此，仍然存在相当大比例的剂量延迟。因此，即使使用Onpro，患者在接受化疗时仍面临挑战，25%的患者因中性粒细胞减少症或其他问题而出现剂量延迟。所以，我们看到有机会进入这个领域，并说我们实际上可以改善护理标准，并与生物类似药或创新药、品牌药合作。因此，我认为我们的便利性很好。在我们的市场调研中，医生对便利性和诊所流程的反应非常积极，因为患者已经在场并且坐在椅子上。所以我们认为，从便利性到与生物类似药或创新药合作，再到改善护理标准，我们有一个非常好的全方位故事。我们认为我们可以真正贯穿整个故事。

Andy Hsieh

很好。谢谢你的回答。我的最后一个问题，我保证。Edward，我想你提到了几次后续的融资活动。你能否告诉我们目前的大致现金余额？

Edward Liu

嗯，如你所知，我们也已经披露过，我们从ATM融资中筹集了1300万美元。我们从7月的后续发行中筹集了3500万美元，并且我们还从中国子公司发行中筹集了大约1000万美元。这给了我们接近6000万美元的资金。我认为到目前为止，由于过去两个月向供应商支付了一些款项，我们的现金略有减少，但我们认为这些现金足以支持两个主要适应症在中国和美国完成新药申请。所以是的，我希望这回答了你的问题。

Andy Hsieh

是的，这非常有帮助。谢谢。非常感谢。好的，非常感谢你回答我所有的问题。

Lan Huang

谢谢你，Andy。

Operator

谢谢。[操作员指示]我们的下一个问题来自H.C. Wainwright的Joe Pantginis。请提出你的问题。

Joe Pantginis

大家好，早上好。感谢接受提问。我有两个问题，如果方便的话。首先，关于即将到来的中期分析，只是关于103号研究的后勤问题。如果像Ramon提到的，没有达到0.012的中期p值，我们是否会看到新闻稿，这是典型的连续性计划新闻稿，还是你们会提供任何额外信息？

Lan Huang

非常感谢，Joe。谢谢你的问题。是的。如果我们有幸达到这个标准，当然，我们必须经过DSMB和FDA的审核，然后宣布这个好消息。但如果我们没有达到，那么如你所知，我们只会发布声明表示研究将按计划继续进行。

Joe Pantginis

好的，这很有帮助。只是想确认一下。我的第二个问题主要想关注公司在即将或预期的中国CFDA提交Plinabulin申请方面的背景活动。在数据出来之前你们能做些什么？或者你们正在做什么准备工作？你们已经提交了任何材料吗？是否必须一次性提交所有材料？同时，关于潜在的商业化准备，你们在幕后正在做什么工作？

Lan Huang

谢谢。我先回答关于中国申报的第一个问题，然后Rich会回答您关于商业准备的问题。这些都是很好的问题。关于中国，我们有不同的规则。如您所知，2017年10月，中国政府发布政策以促进创新，并针对癌症——这是严重影响人口的适应症。他们表示，对于包括晚期癌症在内的危及生命的疾病，公司可以进行新药申请的滚动提交，并可以使用中期数据和疗效趋势进行申报。然后政府会根据疗效趋势给予有条件批准，当然之后公司必须完成整个研究并进行最终分析，如果结果仍然支持批准，政府将给予正式批准。这就是我们当前策略的遵循方式。正如您所见，对于CIN研究，我们在去年12月宣布的105期3期中期分析达到了统计学显著性。数据安全监测委员会也同意这一点，而且从顶线数据来看，我们拥有优越的数据。这两点都将使我们能够在中国提交CIN的有条件批准申请。对于非小细胞肺癌，我们在第一次中期分析中确实获得了相当积极的结果，对吧。[听不清]比值点非常显著，对吧。即使在这个严重受影响的[ph]人群中，nivolumab对比多西他赛的比值为0.73，而ramucirumab联合多西他赛的批准仅基于0.86的比值，对吧。所以这是一个非常令人鼓舞的疗效趋势，使我们也能通过滚动提交进行申报。目前我们尚未提交，这就是为什么在我们的新闻稿中我们提到在2020年第一季度，因为申报材料有很多工作要做。对于CMC部分，我们已经完成；临床前部分我们也已完成；但临床研究报告和其他事项确实需要时间。

Lan Huang

Thanks. I will take the first question on the China submission and then Rich will answer about the commercial readiness question from you. Those are all great questions. So for China, we have different rules there. As you know, October 2017, China government had to issue to really promote innovation, and also to target this cancer -- this is severely the indication for the population. So what they say is for those life-threatening diseases including late stage cancers, the companies can do rolling submission of the NDA and they can use interim data with the efficacy trend to submit. And then the government will give the conditional approval based on the efficacy trend and then later, of course, the company has to finish the whole study and get to the final look and then that if it still supports the approval, then the government will give the approval. So this is how we follow with the current strategy. So as you see that for the CIN study, for the 105 Phase 3 interim we did announce last December that meet the interim analysis to have statistical significance. DSMB has also agreed with that and also we have from topline I will have superior data. So both of them will enable us to submit with China conditional approval for the CIN. And then as you see for the non-small cell lung cancer, we do have a pretty positive interim analysis in the first look, right. [Indiscernible] ratio points is tremendous, right. Even with the nivolumab versus docetaxel in this severely affected [ph] population there has a ratio in 0.73 and then for ramucirumab plus Docetaxel, the approval was only based on ratio 0.86, right. So that's a very encouraging trend in efficacy that enable us to also through the rolling submission. So far we haven't submitted yet, but that's why in our press releases we say in the quarter one of 2020, because there's a lot of things going on for the submission package. For the CMC, we are done, for the pre-clinical we are also done, but also to the CSR and other things, it does take time.

Joe Pantginis

明白了。

Lan Huang

那么，好的。Rich会回答您关于商业方面的问题。

Richard Daly

谢谢，Joe。从理念上讲，我们在美国和中国之间是保持一致的。在这两个国家之间，全球G-CSF使用量的66%来自这两个市场。我们的价格显然比之前公司声明中的要好得多，全球价值的75%在美国，但中国以美元计算正以33%的速度增长。因此，我们相信中国存在巨大的价值和巨大的机遇，不仅因为癌症病例的数量，而且显然因为G-CSF的增长以及改善中国癌症患者护理的机会。所以我们的目标是在这两个关键市场中尽可能保留更多价值。话虽如此，我们希望明智地进入中国市场。我们希望对此非常审慎，因为这显然是一个非常复杂的市场。同时考虑到市场规模，但癌症护理的集中度。中国的癌症护理基本上集中在五个城市。因此，公司不需要覆盖整个国家就能覆盖癌症护理。我们目前正在业务拓展方面努力识别，并且正在与能够——实际上是能够覆盖这些市场的顶级公司进行深入讨论，以及我们在这些市场——特别是癌症市场的经验。但我在这里给您来回解释一下。我们最近在中国的融资让我们非常有信心，我们可以成为这些公司非常强大的谈判伙伴。因此，我们正在寻求通过尽可能多地保留资产的长期价值，为股东创造尽可能多的价值。我们不希望陷入中国持续增长而我们却以非常低的剩余价值获得许可的局面。因此，我们正在努力确保找到最佳合作伙伴。这很复杂。我想说清楚。基于单一分子在中国建立基础设施并不一定是首要任务。然而，我们相信损益表能够支持像Plinabulin这样的产品，因为我们相信价格将相对健康，商品成本稳固。这是一个非常好的商品成本，销售成本将比其他产品轻得多，特别是考虑到中国护理的集中度，我们认为这对我们或我们的合作伙伴来说是一个非常好的机会。因此，我们在中国的讨论已经进入高级阶段，我们相信我们也是一个非常强大的谈判对手或合作伙伴。因此，我们正在寻求最佳价值，并考虑到Lan过去讨论的时间表，寻求快速[听不清]。

Richard Daly

So thanks, Joe. So philosophically, we're aligned between the US and China. So between the two countries, the global amount of G-CSF unit is 66% of the global utilization of G-CSF. So our price is significantly better, obviously from previous statements we've made from the company, 75% of the global value is in the US but China is growing at a 33% clip on a dollar basis. So we believe there's tremendous value and tremendous opportunity in China, not only because of the volume of cancer cases, but obviously because of the G-CSF growth and the opportunity to improve care for patients who are suffering with cancer in China. So our goal is to hold onto as much value in these two critical markets as possible. With that said, we want to be smart about entering China. We want to be really thoughtful about it because obviously it's a very complex market. Also taking into consideration, the size of the market, but the concentration of cancer care. Cancer care in China is concentrated basically into five cities. So one does not have to cover, I should say companies does not have to cover the entire country to cover cancer care. So we're working right now on the BD front to identify and we are in deep discussions with companies who can -- top companies who can actually cover these markets and our experience in these markets -- cancer market, specifically. But I'm sort of giving you the back and the forth on it. The most recent capital raise we had in China gives us great confidence that we can be a very strong negotiation partner with these companies. So we're looking at creating, again, as much value as possible for our shareholders by holding on to as much of the long-term value for the asset as possible. What we don't want to do is get into a situation where China continues to grow and we've -- our license at a very low residual. So we're looking to make sure we get the best partner possible. It is complex. I want to be really clear. It's not necessarily first order priority to build an infrastructure in China on the back of one molecule. However, we believe that the P&L can support a product like Plinabulin because we believe price will be relatively healthy and cost of goods is solid. It's a very good cost of goods and cost of sales will be very light compared to other products and especially with the concentration of care in China, we think this is a really good opportunity for us or for our partner as we think about entering to China. So our discussions are advanced in China and we believe we are a very strong negotiation adversary or partner there as well. So we're looking for the best value possible and the quick [indiscernible] given the timelines that Lan has discussed in the past.

Joe Pantginis

明白了。非常有帮助，Lan和Rich。非常感谢。

Richard Daly

好的。

Lan Huang

谢谢，Joe。

Operator

谢谢。女士们先生们，我们的问答环节到此结束。我将把发言权交还给管理层进行最后总结。

Lan Huang

非常感谢您今天参加电话会议，感谢您对BeyondSpring的持续关注与支持。祝您有美好的一天。

Operator

谢谢。今天的电话会议到此结束。您现在可以挂断电话。感谢您的参与。