Good day everyone and welcome to the BeyondSpring's Inc. Fourth Quarter and Full-Year 2017 Financial Results Conference Call. My name is Brian and I will be the operator on today’s call. Please be advised that today’s call is being recorded. At this time, I'd like to turn the call over for today's host for today's call, Susie Kim with Argot Partners.

Thank you. Before we begin, I'd like advise that remarks made on today's call may reflect forward-looking statements relating to such matters as BeyondSpring's clinical and preclinical research and development activities, regulatory plans, industry trends, market potential, collaborative initiatives and financial projections, among others. These statements are based on currently available information and management's current assumptions, expectations and projections about future events. While management believes that its assumptions, expectations and projections are reasonable in view of the currently available information, you’re cautioned not to place undue reliance on these forward-looking statements. The company's actual results may differ materially from those discussed during the call for a variety of reasons, including those described in the Forward-looking Statements and Risk Factors section of the company's 20-F and other filings with the SEC, which are available from the Investor section of the BeyondSpring's Web site. It is now my pleasure to turn the call over to Dr. Lan Huang, Co-Founder, Chairman and CEO of BeyondSpring. Lan?

Thank you. Ladies and gentlemen, thank you for joining today's call. I'll be giving the main presentation of our update of our pipeline and corporate development and 2017 year-end financials. With me today are Amy Yang, our Controller; and Dr. Ramon Mohanlal, our Chief Medical Officer, who will be available to answer questions during the Q&A portion of today's call. Our newly appointed CFO, Mr. Edward Liu, is still in transition period. Edward had over a decade experience in capital markets, equity financing, merge and acquisitions, global management and investments in healthcare companies. He worked as a Senior Banker at J.P. Morgan and Jeffries and was a partner in a cross-border healthcare focused firm, which is an early investor in BeyondSpring. We are honored to have Edward on board to elevate our company to a new level. 2017 was a remarkable year for BeyondSpring. We're marked by a succession of developments and operational achievements that have put us in position for a number of truly significant clinical and regulatory events in 2018. Just a year following our IPO in the U.S., BeyondSpring is poised for multiple major milestones over the next 12 months that include late stage clinical trial data readout and China regulatory submissions. Specifically, first, for chemotherapy induced neutropenia or CIN, we plan to announce Phase 3 interim analysis data for study 105, evaluating Plinabulin and docetaxel for prevention of CIN in the fourth quarter of 2018, and announce Phase 2 data for the primary endpoint of study 106, evaluating Plinabulin plus TAC which is Taxotere, Adriamycin and cyclophosphamide, also in the fourth quarter of 2018. Pending positive results from these two studies, we expect to submit a new drug application to the China FDA in late 2018 or early 2019 for Plinabulin for a broad target indication…

Thank you, ma'am. [Operator Instructions] And our first question will come from the line of Joe Pantginis with H.C. Wainwright. Your line is now open.

Hi. Good morning, Lan. Thanks for taking the question. Wanted to ask about some of the background activities going on right now. Ahead of the interim data that you are expecting from a couple of the studies later this year, I wanted to see if you could discuss the filing efforts that are ongoing right now ahead of these data? And then part of that question is also, what are you doing now and what needs to still be done with regard to manufacturing in China for Plinabulin? Thanks.

Thank you so much, Joe, and thank you for your support over all these years. So as you know the NDA package is a very large package, and it's an ambitious plan. So as we’re going toward for filing to the end of this year, we are already putting everything together. So NDA package includes a few components. Number one, it includes all the preclinical portion, including the GLP tox study, which were early completed in our package planning. And then, number two is the CMC package, and we’ve already manufactured Plinabulin three batches of API and also three batches of drug product with registration quality in the U.S. and also in China. So those documents are being prepared at this moment and they already past 1-year stability timeline, which is enough for submission for the NDA. And number three, as you know, is the clinical data package for safety. So as I mentioned in my talk, we’ve already had over 300 cancer patients who have used Plinabulin as a cancer treatment drug. So that’s already completes, all the clinical -- after the safety package. So now basically for the CIN indication, we’re just waiting for the data of the Phase 3 interim of the 105 study, which we plan to enroll 150 patients, but the interim data at a 100 patient enrollment, we should complete that portion. And then also, for the 106 study, and the Phase 2 portion should also complete for the clinical efficacy trend for China. So those are basically currently ongoing and when we’ve those data ready, we can plug into the NDA package. And then for the non-small-cell lung cancer study, for the 103 study, as I mentioned, we basically have enrolled over 230 patients already. And then for our interim analysis, we’re waiting for 146 patient test events, and that could be at the end of this year. So those are also in the waiting and then to be plugged into the whole NDA package. So as you see, it's a -- our team is working diligently to put the portions which we already have together and then just to plug into the clinical section. As what you just asked about the manufacturing, so we’re taking the outsourcing way of doing it for the U.S. We’ve two CMOs manufacturing the API and another one manufacturing the drug product. And same thing for China, we also employed two CMOs to do one for API, one is for the drug product. As I just mentioned, we’ve already finished all of the NDA quality three batches, and then those are ready to be put into the writing and submit for the CFDA NDA.

Got it. No, thank you, that’s very helpful. And then one quick clinical question, if you don't mind. With regard to Study 106, can you remind us what you are looking for as the hurdle for superiority? Obviously, statistical significance, but do you have -- you -- can you just remind us what the actual hurdle is?

Okay. So for the 106 study, this is a high risk chemo study. So the chemo is TAC, so basically Taxotere, Adriamycin and cyclophosphamide. So for the TAC, without any use of G-CSF, the duration of severe neutropenia or how many days a patient is in the hospital is around 7 to 10 days. With the use of Neulasta or G-CSF, basically, that DSN reduce to 1.5 to 2 days. So -- and when we calculated for the Phase 3 statistics, as we basically use our previous data of Plinabulin versus the published data of G-CSF, we basically calculate Plinabulin's treatment program to be 0.6 days, and then for the Neulasta arm, it's 1.2 days. So with that, we will only need to use 60 pair of patients to demonstrate the superiority for the DSN as the primary endpoint. Of course, the secondary endpoint includes the bone pain and that Plinabulin should show -- we believe it's going to show superiority as well because G-CSF by its mechanism truly makes the neutrophil -- pushing the neutrophil out of bone marrow, that’s why it has this debilitating bone pain side effect. And Plinabulin is preserving the neutrophil from breakdown, so it does not have those bone pain side effects.

Got it. Great. Thanks for the added info, Lan, and good luck with all of the very busy times ahead.

Oh, thank you so much, Joe.

Thank you. And our next question will come from the line of Jason McCarthy with Maxim Group. Your line is now open.

Good morning, Lan. Thanks for taking the questions. I have a question related to commercialization. As you are approaching filing in China, which should be quickly followed by the U.S., how do you position or see Plinabulin in the landscape of Neulasta, particularly as Neulasta is going biosimilar in the U.S., we expect, maybe later this year? Can you give us some color on the market dynamics of the Neulasta space in China and the U.S. and how you are going to position Plinabulin to take market share?

Well, thank you so much, Jason. That’s a great question. As you know, that G-CSF has dominated the market for the last 30 years, and as you know, G-CSF is a growth factor. So basically, we’re using growth factor to treat cancer patients, so that’s really counterintuitive. And Plinabulin, as you know, is an anticancer drug, so it preserves the neutrophil from breakdown. So from a mechanism point of view, it's definitely superior to G-CSF. And then just from the value proposition of Plinabulin versus the Neulasta or biosimilar G-CSF, I think we can use the four Ps, as below, to explain. So, number one, for the patients, so the first P, so we think Plinabulin has higher quality of life against Neulasta or any biosimilar G-CSF because that’s still G-CSF, right, the same mechanism. So first is, it has high quality of life because we’ve much less bone pain as from the mechanism difference. Number two is Plinabulin is much easier to use because it could be used the first day after chemo dosing. From our Phase 2 study, we can only use -- we basically use Plinabulin 30 minutes right after docetaxel use in one cycle, in one dose, and that’s how we showed its benefit. And Neulasta taking most of the market share is because it can be used one dose, but on the second day of the cycle, right? So number two is we say it also benefits the physicians, the second P, plus Plinabulin is anticancer drug it shows a durable response in combination with docetaxel, and we hope it can also show those with other chemotherapies. So that’s basically the immune effect, so that will be potential high efficient efficacy from a physician point of view to treat the patient. Number two is, it…

Thank you so much, Lan.

Thank you for the questions.

Thank you. And our next question will come from the line of Matthew Cross with JonesTrading. Your line is now open.

Hey, Lan. Congrats on a productive year and thanks for taking my questions. So first off, I was wondering if you could give us just a quick status update on the investigator sponsored combination trials with nivolumab that you presented early data from at the end of January? Could you discuss your expectations for timing of additional data from these and what kind of findings might be presented next? Thanks.

Thank you so much, Matt. Thank you for your support. So for Plinabulin in combo with nivolumab, we’ve conducted investigator initiated study with UCSD and the Fred Hutch. So currently, Fred Hutch has already moved into the Phase 2 portion of the study, so basically, enrolling patients mostly for efficacy whether they’re only for the safety. So out of the 10 patients who we treated with nivolumab and Plinabulin, very significantly, we don't see any Grades 3 and 4 immune-related SAE. As you see from the PD-1, PD-L1 alone, which you see probably 10% to 15% of the immune-related SAE. So this is truly encouraging to show that Plinabulin potentially could even reduce the immune-related SAE. And that would be really helpful because now the PD-1 agent, I think it's very effective, but now taming its use -- its immune-related SAE, some patients have to stop use of drug for life. So as what you talk about, for the additional studies, as you see, we’re progressing nicely into the Phase 2 portion. So hopefully, we should have efficacy data to be shown probably the end of this year, early next year. We are also looking into some biomarkers -- immune biomarkers in the study. So hopefully, that will also further elucidate Plinabulin's immune mechanisms during the clinical study. Thank you.

Great. That’s very helpful, and I will look forward to that data update in 2018 or early 2019. And then I know it's been discussed that given Plinabulin's safety profile and the potential for earlier administration, the drug could be given to intermediate as well as high risk chemo patients. But to my understanding, the gauging of patients' risk of febrile neutropenia from a given chemotherapy regimen is pretty subjective or not particularly consistent from one physician to another. So I was wondering if there was anything you could speak to from your discussions with physicians, through IMS or otherwise, about how potential label differentiation there on the risk here might be implemented in actual practice. Thanks.

Okay. So probably I should give this question to Ramon, our Chief Medical Officer. This very much is a clinical question. Ramon, can you make some comments here?

Yes, thank you. So regarding the intermediate risk, that is fairly well defined by NCCN Guidelines for the use of anti-neutropenia therapies. So the definition of the intermediate risk is based on having an FN risk between 10% and 20%, whereas, for a high risk, that risk would represent 20% or higher risk. There's a long list of chemotherapies that falls within the intermediate segment risk, so there is fairly good guidance what patients will be subjected to intermediate risk for FN. Nevertheless, as you pointed out rightly, is that between physicians, there are different practices in the sense that different physicians, they may make their own decisions regarding when to prescribe G-CSF in these intermediate-risk patients. I would like to point out is that a lot of the behavior for prescription in the intermediate risk also takes into account the cost component that comes with these G-CSF agents, which typically is high. Combined with the cost component also, another consideration is the safety of these agents, and these agents, they do come with serious safety concerns. So we believe that Plinabulin is well positioned in this intermediate segment risk for the reason that it can be offered as cost effective alternative, and it's also a long-acting one-dose cycle alternative. And it comes with a more favorable safety profile, in particular as it pertains to bone pain. We will work very closely with key decision makers to influence the guidelines for NCCN, which typically carries a lot of weight among physicians to influence their prescription decisions. So collectively, we believe we are well-positioned for the intermediate risk segment because we address important limitations for G-CSF products which limits the uptake of these G-CSF products for this intermediate segment risk. And we will work very closely with NCCN members to influence the uptake of Plinabulin in this segment. I also would like to remind you that we have several NCCN members for myeloid growth factors on our development team because they see the tremendous potential that comes with the use of Plinabulin for the CIN indication. Thank you.

Perfect. Appreciate the clarity. I think that does it for me. Thanks, guys.

Thank you.

Thank you. And I’m showing no further questions in the queue. So it's my pleasure to hand the conference back over to Ms. Dr. Lan Huang for some closing comments or remarks.

Okay. Thank you. Thank you for your participation on today’s call and also your insightful questions. You have a good day.

Ladies and gentlemen, thank you for your participation on today's conference. This does conclude our program and you may all disconnect. Everybody have a wonderful day.