Good morning and welcome to BeyondSpring's Fourth Quarter and Full Year 2019 Financial Results Conference Call. My name is Ariel, and I will be the operator for today's call. Please be advised that this call is being recorded. At this time, I would like to turn the call over to the host, Caitlin Kasunich, Senior Vice President at KCSA Strategic Communications. Please go ahead.

Thank you, everyone for joining today's call. I would like to advise listeners that comments made on today's call may reflect forward-looking statements that are related to such matters as BeyondSpring's clinical and preclinical research and development activities and results, regulatory and commercial plans, industry trends, marketing potentials, collaborative initiatives, and financial projections among others. While management believes that its assumptions, expectations and projections are reasonable in view of the currently available information, you are cautioned not to place undue reliance on these forward-looking statements. The company's actual results may differ materially from those discussed during this call for a variety of reasons, including those described in the forward-looking statements and risk factors sections of the company's 20-F and other filings with the SEC, which are available on the Investors section of BeyondSpring's website. Joining us on today's call is Dr. Lan Huang, BeyondSpring, Co-Founder, Chairman and Chief Executive Officer, Dr. Ramon Mohanlal, Executive Vice President of Research and Development and Chief Medical Officer; Richard Daly, Chief Operating Officer; and Edward Liu, Chief Financial Officer. It is now my pleasure to turn the call over to Dr. Lan Huang. Lan?

Thank you. Thank you for joining today's call. BeyondSpring is a global biopharmaceutical company focused on the development of transformative, immunology, cancer therapies for patients with high unmet medical need. As you will hear throughout today's discussion, 2019 was a pivotal year for BeyondSpring. Paving a clear pathway to registration in two significant underserved patient population. In 2019, we have made significant advancements in two lead indications for Plinabulin, CIN and non-small cell lung cancer. Plinabulin is a potent antigen presenting cell APC inducer and we consider it a pipeline in a drug. With around 1,000 patients enrolled globally for Plinabulin, we have a clear vision of indications that Plinabulin can be applied in. It starts with the foundational indication in CIN, followed by non-small cell lung cancer and the future potential is in the triple combination with PD-1, PDL-1 antibodies and radiation or chemotherapy. Besides Plinabulin, we are developing three preclinical immune agents and R&D platform in the targeted protein degradation build. In the COVID-19 pandemic environment to reduce cancer patients' infection and hospitalization rates after chemotherapy is of heightened importance to physicians, patients and health care systems. With Plinabulin's benefit in the CIN indication, we believe that it has the potential to raise cancer patients' neutrophil count after chemotherapy use and prevent infections and hospitalization. This will enable Plinabulin to emerge as a transformative new therapy for the millions of cancer patients in dire need of a superior CIN treatment option and an improved quality of life. Let me share with you our three areas of accomplishments, namely in clinical studies, in scientific mechanism discoveries, and in regulatory filings. First, we have multiple clinical studies to prove Plinabulin's clinical benefit. Our first Phase 3 indication is the CIN indication. To date, five clinical studies have demonstrated Plinabulin's benefit…

Thank you Lan. First I would like to provide an update to our registrational trials for Plinabulin. I will start with Studies 105 and 106 which evaluate Plinabulin's efficacy in preventing CIN. We reached alignment with both the U.S. FDA and China's National Medical Products Administration, NMPA on the fact that these studies would support a broad CIN label for all cancers, all chemotherapies combined with G-CSF. Recent data from Studies 105 Phase II portion demonstrated that Plinabulin given as a single dose cycle on the same day of chemotherapy is not only as effective as Neulasta, but also causes much less bone pain and improved quality of life and offers a superior immune profile compared with Neulasta. It also has a benefit regarding thrombocytopenia. As such Plinabulin's non-G-CSF based unique mechanism of action potentially makes it complementary to Neulasta in preventing CIN. Additionally, previous top line data from Study 106 Phase II portion of this trial suggests a significant improvement in efficacy when treating CIN. The significant decrease in the percentage of patients, who are experiencing Grade three or four CIN a more than 90% reduction in patients experiencing bone pain and a reduced potential immune suppressive phenotype when adding Plinabulin to the standard of care. As Lan mentioned on Wednesday, we announced that we discussed with the U.S. FDA our proposed primary endpoint change for the Study 106 Phase III superiority clinical trial. The new primary endpoint is measured by the percentage of patients who did not experience Grade four neutropenia. We believe this new primary endpoint is more clinically relevant and sets a new standard to evaluate superiority in CIN. With the Plinabulin and Neulasta combination 52.5% of patients we have protected from Grade four neutropenia versus 40.9% in G-CSF, a 53% increase in protection compared to…

Thanks, Ramon. It's clear that there's a need to address the treatment gap surrounding CIN. Today I'd like to emphasize a number of points that support our case as well as the impact that COVID-19 is having on cancer care and the potential role that Plinabulin can play. First, I want to applaud Ramon and his team for their leadership and vision in the design and conduct of the Plinabulin CIN clinical program. BeyondSpring's approach to addressing CIN has been to move beyond supportive care and to pivot to improving cancer care. The data generated to date demonstrates that Plinabulin has the potential to deliver on this promise. As discussed previously, CIN remains the number one reason for modifications in chemotherapy care. When white blood cells drop to dangerous levels oncologists are forced to alter care. As mentioned before, we call this the 4Ds patients are forced to decrease their dose or even delay downgrade or discontinue therapy. The results can be devastating for patients. Relatively minor changes in care can result in significant changes in outcomes. For instance, a 15% reduction in Relative Dose Intensity or RDI could reduce overall survival by 50%. Additionally, just 15 days of delay in delivering chemotherapy over six cycles in breast cancer patients can result in a statistically significant reduction in overall survival. We believe that Plinabulin has the potential to go beyond supportive care. And we believe that Plinabulin when used in combination with G-CSF can improve compliance and persistency with chemotherapy, and potentially improve cancer care outcomes. Next, I'd like to address the environmental changes that we've experienced in the recent weeks due to COVID-19 that have expanded the CIN market. According to IQVIA, patient visits to oncologists are down 20% nationwide since the pandemic hit, due to social distancing guidelines.…

Thanks Rich. I'll now briefly discuss our fourth quarter 2019 financial results. For greater details related to these results and our full year 2019 financial results, I refer you to our press release issued this morning and to our 6-K filing both of which can be accessed under the Investors section of our website. With that said, I will now highlight some of the key numbers. R&D expenses in the fourth quarter of 2019 were $12.6 million, compared to $13.3 million in the same period of last year. The decrease of $0.7 million was largely attributable to a $0.5 million decrease in clinical trial expenses and a $0.2 million decrease in non-cash share-based compensation. G&A expenses were $2.7 million in the fourth quarter of 2019, compared to $2.3 million for the same quarter of 2018. The $0.4 million increase was mainly due to an increase in employee salaries and welfare. Net loss attributable to BeyondSpring in the fourth quarter of 2019 was $14.1 million, compared to $14.7 million for the same period of last year. Our cash balance at the end of Q4 was $35.9 million. We are confident that our current cash resources are sufficient to support our clinical trials and NDA submissions in China and the U.S. for Plinabulin for both CIN and non-small cell lung cancer indications, as well as to advance our immuno-oncology pipeline and protein degradation research platform. With that, I will now turn the call back over to Lan to conclude. Lan?

Thanks Edward. As I'm sure you will agree, we are extremely proud of our clinical development efforts and the flow of data that further validates Plinabulin's favorable drug profile to improve cancer care. Plinabulin is the only novel agent in development that combines both anticancer and CIN prevention potential due to its very unique mode of action. Looking ahead, we expect many important data and regulatory milestones in 2020, which will transform us from a clinical-stage company to a commercial-stage company. Together with our shareholders, investors and partners we are working hard to continue to create value and deliver innovative medicines to patients with severely unmatched medical need all over the world especially during COVID-19. I look forward to keeping you updated on our progress towards that goal in the coming months. Now, we are open to questions. Thank you.

Thank you. We will now begin the question-and-answer session. [Operator Instructions] Our first question comes from Maury Raycroft of Jefferies. Please go ahead.

Hi. Good morning everyone and thank you for taking my question. Congrats on the endpoint change, it seems to make sense and could be an important update for the program. I'm wondering if you can talk more about the background of how the endpoint change came about. I guess for example was it based on feedback from advisers, FDA advice or from the broader market research that you did?

Yes. Probably, Maury I can start answering your questions. So as you see that G-CSF is only standard of care currently for the last 30 years. Even with G-CSF, it's primary endpoint has been evolving in the last 30 years starts with severe neutropenia rate, right? And Neupogen compared to no therapy and later in 2000 when Neulasta has to be approved, an NDA actually spend a lot of energy also to get the new primary endpoint which is the duration of severe neutropenia, as the primary endpoint because it's a very good biomarker. And also you can have fewer patients to do the clinical trials and they also have to spend time to correlate DSN with rate. So currently as you see the DSN is a very good primary endpoint for the non-inferiority trials but it does have ceiling effect. With the TAC plus G-CSF it's – currently the DSN is around 1.2 days. So there is a pretty high ceiling and it's very hard to – it is good we can make it better than 1.2 day but the gap is pretty small. So with our discussion with our key opinion leaders and also probably also from our market research from the physicians we had a discussion with FDA. Because as you know G-CSF still did not meet the anemical needs of Grade four neutropenia. And Grade four neutropenia through literature research it is directly correlated to infection, FN, hospitalization and you can also test. And for G-CSF the current – is still at 83% to 93%. So that gives us a big range of reduction for our combination achievable. So if we can achieve that then you have a very good ANC number like what the physicians are saying which is going to maintain the defense for the immune system. And then also can enable the chemo dose for the optimum survivor benefit. So that was for the history and also our thinking. And then also we have aligned with the FDA currently. So probably I can also ask Ramon to add a few words to this.

Yes. Thank you, Lan. First of all I would like to state that we are very confident that we will also see a benefit with DSN with the combination over monotherapy alone. But secondly probably more important is that the concept of DSN not only has been poorly understood by the scientific and medical community but also by the commercial community. DSN is a concept. It's very difficult to understand. The concept of having no Grade four neutropenia at all avoidance, total avoidance of Grade four neutropenia and that you have more patients with total avoidance of Grade four neutropenia with the combination of Plinabulin and Pactamycin that is so much clearer for clinicians, scientific community but also from a commercial perspective. It is not only clearer but also more impactful. So those are very arguments that we are able to convey successfully to the FDA and hence their willingness to discuss with us this change in primary endpoints. Thank you.

Got it. That was very helpful. And then the second question I had was – I just wanted to clarify in the press release yesterday, it said a robust plan will be submitted to the FDA to prospectively validate this new primary endpoint I guess is that plan finalized? When will it be submitted? And will it be validated before you eventually file for approval just to clarify on that?

Yes. So if I can just quickly answer this. This plan has been submitted actually. So, yes. So it's to validate that Phase I neutropenia or no Phase I neutropenia how it's related to the clinical consequences of such as infection or FN or hospitalization and that those kinds of consequences. And we will be able to locate it from our prospective from our 106 Study. And also we will do the integrated efficacy summary to also look at this.

Got it. So in the 106 results that will basically validate the plan then?

Yes.

Okay. Okay. And then the last question I had was just – we're looking forward to the 106 update. And in your 3Q 2019 press release you stated the study 106 readout would be a final readout in the first half of 2020. But in the press release today it says the 106 update this quarter will be an interim. And so I was just wondering, if you could explain the change and talk about what specifics we could see in the interim update this quarter?

Yes. So probably, I can answer this quickly. Yes, thanks so much for the great questions. So currently, I think, our time line is for the -- because of all of those very important time point to get to this interim analysis. As you also see there is the primary endpoint change. So currently the time line is 106 Phase 6 interim of like 120 patients will be done this quarter, which is quarter two. And then the final will be done in the second half of this year.

Okay. And then the update this quarter what should we expect -- what kind of specific measures should we expect in that update to be recorded?

So well at least you will see the -- the new primary endpoint the avoidance and prevention of Phase 1 neutropenia in the primary endpoint with certain p-value right? So we probably will save all the detailed data for a scientific conference.

Got it. Okay. Thank you very much for answering my question. Congrats, again.

Yeah. Thank you so much, Maurice. Thank you for your support.

Our next question comes from Andy Hsieh of William Blair. Please go ahead.

Excellent. Thanks for taking my question. Hope everybody at BeyondSpring is well and staying healthy. And congratulations on a great year in 2019. So I have a couple probably more related to the non-small cell lung cancer. So I think, Ramon kind of talked about the first interim look and then the final analysis timing. Just wondering where you are in the second interim analysis? I think last quarter you mentioned that the number of events actually trigger the second analysis. So any sort of information that you can provide would be much appreciated.

Yes. So probably I can start and Ramon can add to this. So we have reached our second interim analysis for the non-small cell lung cancer at the past event. So we will have a DSMB meeting soon. And with that then the DSMB of -- as a company, we really cannot it's blinded to us on the efficacy data. So with the meeting they will advise us to go forward or not based on the efficacy and also the safety data. So that's all we can say. So Ramon, you have anything to add?

Yes. Thank you, Lan. I have nothing to add. Thank you.

Okay. So I also have a related question and I don't know if this has been discussed before, but in the enrollment for Dublin-3 EGFR mutant patients are excluded and that's a little bit different from other second-line studies that we have seen given the fact that they could have already received drugs that specifically address these driver mutations. So just curious about the decision to exclude these patients?

Yes. So probably, I can start on this. So as you know that currently TKI -- the Tarceva the Tagrisso they are very good for the EGFR mutant population right? So they are -- in our mind they're really not -- the more severely unmet medical need. With the EGFR wild-type patients if you look at the TAILOR study Tarceva actually was worse in the overall survivor versus docetaxel in the EGFR wild-type patients. And meanwhile, EGFR wild patients -- wild-type patients is considering around 85% of the Western population. So in our judgment we do think the lung cancer with EGFR wild-type are the more severely unmet medical need population. Those are the patients we need to develop the agent to help. So that's one of the rationale why we only focus on EGFR wild-type. And secondly, also this is a global trial. There is a difference in the percentage of EGFR mutant or wild-type in the different solicity. So for the western patients EGFR wild-type is around 85%. But in the Asian population it's around 70%. And the patient with biomutant actually live much longer than the EGFR wild-type patients. So it's largely a global trial if we do not get -- if we do not include -- if we do include the EGFR mutant patients then -- so the data will be very hard to analyze. And also EGFR mutant they are living much longer. So the study is going to be very long to conduct. So that's our reasoning why we are only targeting the EGFR wild-type patients. I don't know if I answered your question.

Okay. Yes. No that's actually a perfect answer. Thanks for that. So last question I have, has to do with the endpoint change. So, Lan, I think you kind of talked about the goal of kind of positioning Plinabulin as all cancers, it's broad label. And so, help us understand the endpoint change for 106. Is that going to impact 105 as well, as you're waiting for the final analysis? I'm just curious, because ultimately you have to put all the data package together as one. So just curious, if you're planning on continuing the duration for -- duration endpoint for 105 and then a new endpoint for 106, or are you going to combine them together into one?

So that's a great question. So as you see that the 105 primary endpoint is not going to change, because 105 is a non-inferiority trial, right? So DSN is a good endpoint for non-inferiority trial. So it's not going to change. Only is going to be changed in the 106, because that is the superiority trial with a new regime, which has potential to improve care as in we need more a clinical relevant and more robust endpoint to measure the superiority. So it's only going to be changed in the 106.

I see. Okay. Yes, that makes sense.

All together. Yes. 225. Yes.

Okay, great. Thanks for taking all my questions and congratulations again.

Thank you for you great questions. Thanks, Andy.

Our next question comes from Christopher Marai of Nomura. Please go ahead.

Hey. Good morning and thank you for taking my questions and congratulation on your updates, its great progress. So number one, just to clarify the change in the primary endpoint on Study 106, was that based on an FDA request, or did you initiate this request?

Okay. Yes, we did initiate this discussion with FDA. Because this is also --

You did.

Yes, it does. But we did discuss with them extensively.

Great. In terms of also, obviously, Study 105, there's been an interim analysis of additional data. Have you been able to look at that with respect to the new endpoint? I know it's a different study, it's not in combination, but in terms of prevention of Grade 4 neutropenia, have you any data from that 105 Phase 3 study that might be relevant here?

Yes. So we do look at -- well, so the 105 Phase 3, if we look at the Grade 4 neutropenia rate in the first week, which is the -- we want to show the early onset of action we do see a benefit there as well. We have less Grade 4 neutropenia percentage in the first week in the 105 study, versus the Neulasta by itself. So you see a rapid offset as well. So that's like a better result. But for the primary endpoint, we're not changing, it's still DSN.

Got it. Okay. And then, do you anticipate to also, in your U.S. NDA filing, include data from -- the interim data from 106, as well as obviously the 105, you'd I think previously planned to submit for approval?

Yes. So that's a great question. So it's always has for the U.S. FDA approval for broad label, we always have planned to submit 105 and 106 data together, because it takes two studies to validate. So they'll both be combined to submit.

Okay. And then just with respect to that then, on the 106 interim will you report the DSN endpoint as well as your new primary?

Well, I don't know if we can at this moment, because usually the interim, I think, well, I cannot -- I have liberty to say, because this is going to be in discussion with the independent -- the decision. But we are confident that the Grade 4 neutropenia avoidance actually is more robust. And what, if it needs, yes, it should meet as well.

Got it. Okay. And then, any progress with EU regulators on the path? And how does this endpoint perhaps work with that process?

Yes. So EU, I think, our strategy is to first file for U.S. and China. For that EU -- is we are planning to have meetings with EMA. And then talking to them about our studies. But of course now with COVID-19, it's a little bit hard to meet with anyone. So -- but it's in the planning to discuss with the EMA.

Okay. Excellent. And then I guess you recently presented some new data that highlights Plinabulin's ability to prevent tissue iron overload. So is there any plan to initiate a clinical study around that observation? It's obviously helpful in several diseases and probably also relatively low-hanging fruit like CIN. Maybe walk us through how you might look to explore that data set more clinically?

Yes. So probably I can let Ramon to comment on this. Ramon has the most experience in this indication. Yes, Ramon?

Yes, thank you. Yes, we certainly have plans as you indicate this is low-hanging fruit for us. This is an additional benefit that Plinabulin offers in the chemotherapy setting. So with chemotherapy as we know a common side effect is neutropenia. And that's where the Plinabulin indication in CIN comes in. But equally important as you know, a common side effect with chemotherapy is myelosuppression that often leads to anemia, so not only neutropenia but also anemia. The anemia then typically in chemotherapy patients is addressed by blood transfusion. And most cancer patients they have numerous and chronic blood transfusions over time. With blood transfusions patients get iron overload because then the block in the patient degrades and the iron becomes freely available. Iron that sits in tissue then creates iron overload and tissue damage. So Plinabulin has a very broad benefit in patients receiving chemotherapy. We -- the emphasis currently is on neutropenia prevention. But then, we have all these additional benefits, so with chemotherapy and anemia and the iron overload Plinabulin then also will have that major benefit. This is very relevant. This is a very relevant finding with Plinabulin because we see increasingly that the trend is that cancer patients live longer. Now cancer patients also -- in cancer patients, we also combine chemotherapy with immunotherapy. Therefore paces increasingly live longer. The trend now become for cancer patients to live longer. If then the patient had suffered had been exposed to iron overload due to blood transfusions that will impact the quality of life over time. So with cancer patients increasingly living longer, our attention will switch to how then can they live longer at a high quality of life with the lowest morbidity over time. Iron overload reduces morbidity over time and we see here a benefit that Plinabulin also will address that. And therefore it's a very big advantage looking forward.

Excellent. Thank you for the comprehensive reply. Appreciate that and congratulations on all the progress.

Thank you very much Chris. Thank you for your support and your brilliant question.

This concludes the question-and-answer session. I would like to turn the conference back over to Dr. Huang for any closing remarks.

Thank you so much for all your brilliant and insightful questions. And also thank you for all the listeners to our call and I hope everyone has a nice day and a nice week forward. Thank you.

This concludes today's conference call. You may disconnect your lines. Thank you for participating and have a pleasant day.