BeyondSpring Inc. (BYSI) Q1 2017 Earnings Report, Transcript and Summary

Good day, everyone, and welcome to the BeyondSpring Quarterly Investor Conference Call. Today's call is being recorded. At this time, I'd like to turn the conference over to Mr. Garth Russell of KCSA Strategic Communications, BeyondSpring's Investor Relations firm. Please go ahead, sir.

Thank you, operator. Before turning the call over to management, during today's call, management may make forward-looking statements relating to such matters as its clinical and preclinical research, research and development, industry trends and collaborative initiatives. These statements are based on currently available information and management's current assumptions, expectations and projections about the future events. While management believes that its assumptions, expectations and projections are reasonable in view of 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 section of the company's 20-F and other filings with the SEC, to which your attention is directed on the company's Investor Relations website. With those comments complete, it's my pleasure to turn the call over to Dr. Lan Huang, Co-Founder and Chairman and Chief Executive Officer of BeyondSpring. Lan, the floor is yours.

Thank you, Garth, and thank you, everyone, for joining our call today. On the call with me today are Dr. Ramon Mohanlal, our Chief Medical Officer; and Richard Brand, our Chief Financial Officer. I'm delighted to welcome everyone to our first investor communications being successfully completing our initial public offering on March 9. As this is our first quarterly conference call, I want to take this opportunity to provide a broad overview of BeyondSpring. BeyondSpring is a late-stage global clinical development company with a robust immuno-oncology pipeline. Our lead asset, plinabulin, is currently in global registrational trials for 2 large cancer indications with near-term catalysts over the next 6 to 12 months. We also have several preclinical IO drug candidates and a research platform targeting ubiquitination degradation pathway in collaboration with University of Washington. BeyondSpring is committed to developing drugs in a manner that benefits both the patient and the medical community. We are confident that our disrupted U.S.-China drug development model has the potential to result in a more efficient and cost-effective drug trial process, which in turn should reduce time to market and may ultimately reduce cost to the patient, solving the pricing problem of innovative medicine. Finally, I'm gratified to have been able to assemble a world-class internal team who collectively have brought to market more than 30 innovative drugs. And I am appreciative of the support we have received from the Fred Hutchinson Cancer Research Center and the University of Washington through our significant collaboration. Our lead asset, plinabulin, is a synthetic analog of a marine-derived small molecule, which alters the tumor microenvironment and may provide multiple therapeutic opportunity. Through our 3-year collaborative effort with the University of Basel and Massachusetts General Hospital, now we understand that plinabulin is a GEF-H1 activator. Plinabulin destabilizes microtubule network in the cell's cytoskeleton and releases the guanine nucleotide exchange factor, GEF-H1. This activates downstream signal transduction pathways, leading to dendritic cell, DC, maturation, T-cell activation and neutropenia prevention. Plinabulin is differentiated from other microtubule depolymerization agents such as the CA4P class, which cannot induce DC maturation or neutropenia prevention. BeyondSpring acquired the rights to plinabulin from San Diego-based Nereus Pharmaceuticals for the Hong Kong and China rights in 2010 and expanded our reach by acquiring the global rights in 2013 in exchange for 10% of our pre-IPO shares and no royalty payment. Nereus conducted the Phase I/II trial with Quintiles as the CRO in the U.S. and other Western countries. This is the data from which is the basis of our current Phase III trial. BeyondSpring is grounded on a novel, highly scalable business model for drug development that aims to leverage integrated clinical resources in the United States and China to develop innovative cancer therapy. We are confident that conducting trials in China provides BeyondSpring with a competitive advantage, including accelerated clinical enrollment, reduced trial costs and faster regulatory approval process, and very importantly, access to the country's large and growing cancer patient population. No different than other industries, drug development has become a global process. In fact, more than half of our clinical trial sites today are held outside of the U.S., which means that 80% of applications to the U.S. FDA for drugs and biologics include data from ex-U.S. clinical sites. This also includes China, which has developed a world-class clinical drug trial infrastructure, adhering to the most stringent and U.S. FDA-accepted clinical and regulatory standards. BeyondSpring is not alone in integrating China into its clinical trials process and data submissions to the U.S. FDA. Examples of these efforts include afatinib, a first-line non-small cell lung cancer drug that was approved by the U.S. FDA in July 2013, which had 72% of patient data from China in Stage 3 trials. Another example is AstraZeneca's IRESSA, which received EMA approval for first-line non-small cell lung cancer, with 99% of pivotal trial data coming from China. China also had participated in Phase III trials for the approval of AstraZeneca's Tagrisso, Bayer's NEXAVAR and Pfizer's crizotinib. To support our robust pipeline, innovative business model and objective, BeyondSpring has assembled very tremendously talented senior leadership team, which is comprised of individuals, each at the top of their game, with decades of experience in drug development. I'm a scientist turned entrepreneur with over a decade experience in the U.S. and China. I was trained at UC Berkeley and Memorial Sloan Kettering Cancer Center. And BeyondSpring is my fourth company. In 2009, I was very honored to be the recipient of China's Thousand Talent Innovator Award, an important distinction in China. Dr. Ramon Mohanlal, our Chief Medical Officer, has over 20 years of global experience in strategic drug development at big pharma and biotech start-up. He has played a crucial role in bringing 5 drugs to the market. Shortly before joining us, Dr. Mohanlal was the clinical head of established oncology products for Novartis. Dr. Ken Lloyd, our Chief Scientific Officer, has more than 45 years of experience in the pharmaceutical industry, with a focus on novel drug discovery and development, working in large pharmas such as Hoffman LaRoche and Wyeth. He was integral in bringing 6 drugs to the market, including Ambien. And finally, Dr. Gordon Schooley, our Chief Regulatory Officer, has 35 years of experience in the pharmaceutical industry, with a focus on clinical and regulatory affairs. Dr. Schooley has been associated with product development and approvals of 19 marketed drugs in the U.S., EU and Pacific Rim countries. Switching gears, allow me to provide greater detail surrounding our work in the clinic. For today's discussion, I'm going to center my discussion around BeyondSpring's most advanced drug indication. Although it is worth expressing the excitement, we have a number of our preclinical trial candidates, which activate T-cell and are producing new antigens, turning cold tumor into hot. Plinabulin is our lead asset. In combination with docetaxel, a leading chemotherapy, has delivered encouraging data in the Phase II portion of the Phase I/II clinical trial in the U.S. and other Western countries in the reduction of docetaxel-induced severe neutropenia and as an anticancer agent in increasing overall survival in a subset of patients with advanced non-small cell lung cancer who have measurable lung lesion. As a consequence of this clinical result, our current efforts are focused on 3 indications: number one, chemotherapy-induced severe neutropenia across several types of cancer; number two, in combination with docetaxel for advanced non-small cell lung cancer; and number three, in combination with nivolumab for advanced non-small cell lung cancer. We believe that pursuing this prospect provides BeyondSpring with the opportunity to seek regulatory approval for plinabulin for multiple indications. For the first indication of prevention of chemotherapy-induced neutropenia, let me share with you its background and market potential. Neutropenia is an abnormally low concentration of neutrophils. Neutrophil is a type of white blood cell, which may result from an abnormal rate of destruction or low rate of synthesis of white blood cells in the bone marrow. Specifically, patients with low neutrophil counts are more prone to bacterial infection, which are a significant cause of mortality in cancer patients. Every year, more than 60,000 patients in the U.S. are hospitalized for neutropenia associated with fever and infection, resulting in a mortality rate of between 9% and 18%. The current standard of care for neutropenia is biologic drugs based on G-CSF, a human growth factor that stimulates the level of white blood cells, also known as neutrophils. While annual worldwide sales of G-CSF drugs such as Amgen's Neulasta exceed $7.3 billion, they are limited by safety concerns and are required to be administered the day after chemotherapy use, which represents a significant inconvenience and a potential danger to patients. In contrast, plinabulin is administered on the same day 1 hour after chemo, which we believe is a more effective and tolerable cost of treatment. Data from the Phase II study was extremely encouraging, where plinabulin reduced severe neutropenia induced by docetaxel from 26% to less than 5% with a p-value of 0.0003, with 3 0s in the middle. So this is highly statistically significant. This data was generated in around 20 patients, which underscores plinabulin's material effect. This data was later presented at December 2016 ASH meeting. Now based on the clinical profile of plinabulin and our communication with FDA, we are starting enrolling patients in 2 Phase II/III trials of plinabulin for the prevention of neutropenia across several types of cancer. The first trial is a Phase II/III trial in around 200 patients in the United States, other Western countries and China of plinabulin in combination with docetaxel in patients with solid tumor consists of breast cancer, prostate cancer and non-small cell lung cancer. The primary endpoint for this trial is noninferiority in duration of severe neutropenia in the first cycle compared to pegfilgrastim or Neulasta. Each cycle is only 21 days, so the trial is very short. And I'm very excited to report to you all that we have enrolled the first patients in this trial and expect to obtain initial result for the Phase II portion in the second half of 2017 and interim data for the Phase III portion in the first half of 2018. The second trial will be a Phase II/III trial in around 200 patients in the United States, other Western countries and China of plinabulin in combination with a myelosuppressive chemo regimen consisting of 3 agents, TAC, in patients with breast cancer. The design of this trial will be substantially similar to the ongoing trial of plinabulin with docetaxel. However, this trial will be powered to measure superiority in duration of severe neutropenia in the first cycle. We expect to commence this trial in the first half of 2017 and to obtain final results from this trial in the first half of 2019. Dr. Douglas Blayney of Stanford, a board member of the National Comprehensive Cancer Network, NCCN, and a contributor to the NCCN Guidelines for neutropenia management, is our principal investigator for both trials. If our Phase II/III plinabulin trials are successful, we intend to submit an NDA for a broad indication for prevention of severe neutropenia induced by all myelosuppressive agents. Our second indication for plinabulin is in combination with docetaxel for advanced non-small cell lung cancer, which accounts for around 87% of lung cancer cases, and it is where BeyondSpring is directing its efforts. Despite availability of multiple drugs to treat non-small cell lung cancer, we believe there remains a great need for novel therapies in this field. Data from the Phase II portion of the Phase I/II trial in non-small cell lung cancer suggests that the addition of plinabulin to docetaxel may increase antitumor activity compared to docetaxel alone. Specifically, a subset of 38 patients with measurable lung lesions given a combination of docetaxel plus 30 milligrams per liter square plinabulin had a median survival of 11.3 months compared to 6.7 months in docetaxel alone. In addition, the plinabulin plus docetaxel cohort had an objective response rate, a measure of the proportion of patients with tumor size reduction of at least 30%, of 18.4% compared to 10.5% for the docetaxel monotherapy arm. While the number of patients in the subset was not large enough to demonstrate statistical significance, we and our clinical collaborators believe this data suggest the addition of plinabulin to a standard regimen of docetaxel may provide a clinically meaningful increase in antitumor activity compared to docetaxel alone. In summary, the result of this randomized trial was given as an oral presentation at the 2017 ASCO-SITC Clinical Immuno-Oncology Symposium by Dr. Alain Mita of Cedars-Sinai Medical Center, Los Angeles. The Phase III trial is actively enrolling in the U.S., China and Australia. This trial is expected to enroll 550 patients, 80% of whom will be in China and 20% at sites in the United States and Australia. The primary endpoint is overall survival. We'll utilize this data from this trial to submit approval applications in the U.S. and China, which represent the 2 of the largest pharmaceutical markets in the world. With the fastest-growing cancer market in the world, around 700,000 cases of lung cancer diagnosed in China in 2015, the treatment of lung cancer is a health care priority in China. In addition, as I am a recipient of China's Thousand Talent Innovator Award, BeyondSpring is eligible for an accelerated review track for approval by the CFDA. Our lead clinical investigator in the United States is Dr. Luda (sic) [ Lyudmila ] Bazhenova from University of California, San Diego. Dr. Bazhenova was a principal investigator for the Phase II portion of the Phase I/II trial of plinabulin and has been an investigator of over a dozen lung cancer trials. Our lead clinical investigator in China is Dr. Yan Sun, the Director of National Academy of Science Cancer Hospital in Beijing, a hospital that treats 320,000 patients a year. Dr. Sun was also the lead clinical investigator for the Phase III trials of other lung cancer drugs that received approval from the CFDA. He was trained at MD Anderson and is a National Academy of Science member in China. We anticipate interim data for this trial to be available in the first quarter of 2018 and the final data available in first quarter of 2019. Multiple U.S.-based Phase I/II trials of plinabulin, in combination with nivolumab, have received regulatory approval. In September 2016, the University of California, San Diego, enrolled the first patient in the investigator-sponsored Phase I/II trial. In addition, the Fred Hutchinson Cancer Center and the University of Washington are planning to launch another investigator-initiated Phase I/II trial. We expect to initiate a global pivotal trial of plinabulin in combination with PD-1 in 2018. The work we are doing with plinabulin and the talented team we have assembled has attracted exciting collaborations for R&D and preclinical and clinical research. We are collaborating with Dr. Ning Zheng, a Howard Hughes Medical Institute Investigator, and his group at the University of Washington on a unique molecular group to selectively target certain oncogene proteins with E3 ligase, which is one of the ubiquitin ligase enzymes. Dr. Zheng and I were the first to solve the crystal structure of 2 classes of E3 ligases and this discovery formed the structural basis in selecting the small molecules to be studied as a potential molecular glue agent. With the capital we raised through the IPO and the concurrent private placement, we have a clear path forward to the clinical programs I have discussed, as well as some of our earlier-stage clinical trials. We look forward to providing additional updates in the quarters and years to come. With that, I will turn the call over to Richard.

Thank you, Lan. I would also like to thank everyone for your participating on today's call. In March of this year, we successfully completed our IPO, selling 174,286 ordinary shares of BeyondSpring at $20 per share. Concurrently, we completed a private placement transaction for 2,541,048 ordinary shares, also at $20 per share. Total net proceeds to BeyondSpring were approximately $48.17 million after deducting underwriting fees and other expenses. Admittedly, completing an outside private placement concurrent with our IPO is atypical. That said, a number of our existing strategic investors, including HuaRong, the largest asset management company in China with AUM of $150 billion globally, wanted to invest at significant levels that only the private placement structure would allow. At the end of the day, BeyondSpring was able to satisfy the needs of those investors while at the same time creating a public market for its shares, which we consider a win-win. Turning to our financials. For the full year 2016, research and development expenses were $10.4 million compared to $6.3 million in 2015. The increase in R&D expenses in 2016 was primarily due to increased costs related to the ongoing Phase III trial in advanced non-small cell lung cancer, including a higher number of patients, additional investigator sites and additional drug cost, as well as our planning for the Phase II/III trial for docetaxel-induced severe neutropenia. Our general and administered expenses for 2016 were 1.7 -- $1.9 million, excuse me, compared to $1.2 million in 2015. The increase in G&A expenses was primarily due to an increase in personnel costs and outside professional service expenses incurred preparing for the IPO. We reported a net loss attributable to BeyondSpring Inc. of $12.0 million for 2016 compared to $8.0 million for 2015. As of December 31, 2016, we reported cash and cash equivalents totaling $11.7 million, which does not take into account the capital raised from our IPO and the concurrent private placement. The net proceeds we received from our IPO and concurrent private placement were $48.17 million after deducting underwriting fees and other expenses. We plan to invest approximately $20 million to $23 million to conduct 2 Phase II/III clinical trials, enabling us to submit to the FDA for chemotherapy-induced severe neutropenia. We also plan -- from the March financing proceeds, we plan to invest $5 million to $7 million to pay certain expenses in connection with a Phase II trial of plinabulin in combination with nivolumab for the treatment of non-small cell lung cancer. Most of our Phase III non-small cell lung cancer trial of plinabulin in combination with docetaxel, those costs are recovered by our cash on hand prior to the March financing. Based on these and other investments in R&D as well as our current operating plan, BeyondSpring believes it has sufficient cash resources necessary to file the NDA for plinabulin for the prevention of neutropenia and the NDA for non-small cell lung cancer for measurable lung tumors in combination with docetaxel. In addition, our approach can minimize dilution for the shareholders. With that, allow me to turn the call back over to Lan.

Thank you, Richard. I'm extremely proud of the entire BeyondSpring team and wish to express my sincere gratitude for their ongoing effort. I also want to recognize the contributions to our success, including our investors, employees and Board of Directors as well as our investment bankers and other professional service providers. Each of these groups played an integral role in helping BeyondSpring achieve its milestones to date. And the last, but not the least, I would like to thank the patients who participated in our trial. We also believe we have exciting catalysts over the next 24 to 30 months. First, within the next 6 months, we expect to have Phase II data from our neutropenia study. Second, over the next 12 to 18 months, we expect interim Phase III data from both our neutropenia and the lung cancer study and data from our PD-1 combo study. In addition, we expect to submit IND for BPI-002 for T-cell activation. Number three, which is, finally, over the next 24 to 30 months, we expect final Phase III data from both our neutropenia and non-small cell lung cancer study and several R&D submissions, including Phase III PD-1 combo, BPI-004 in Phase I and a molecular glue agent from our collaboration with the University of Washington on a research platform. As you can see, there's a lot of movement and excitement surrounding BeyondSpring's activities and I look forward to sharing updates as they occur. With those comments complete, operator, we are now ready to open the call for questions.

[Operator Instructions] Our first question is from Joe Pantginis of Rodman & Renshaw.

A couple of questions, if you don't mind. First, I'd love for you to provide a little more color from some of your prepared comments about how plinabulin might be differentiated from other microtubule destabilizing agents.

Thank you, Joe. This is Lan. Yes, this is a great question. As you know, from our current poster presentation at the Keystone meeting in March 23 with Dr. Zippelius and Dr. Reinecker from Harvard, we have seen that other microtubule depolymerization agents, such as the CA4P class, do not activate the DC maturation. So it does not actually induce the neutrophil protection or the neutropenia prevention. The mechanism behind that is mostly due to the molecular structure because the plinabulin actually binding to a different amino acid in the beta tubulin of these alpha-beta tubulin compacts. So the binding to this alpha-beta tubulin can release the GEF-H1. And meanwhile potentially CA4P class, but they don't bind to the same amino acid so couldn't release this GEF-H1, which is the key activator for the DC maturation. And from the clinical data of the effect is we have seen that CA4P in combination with carboplatin and paclitaxel in lung cancer, they show Grade III and IV neutropenia at the 75%. Another microtubule depolymerizing agent also in the same class of CA4P is ombrabulin and that compound, also in combination with cisplatin and paclitaxel, showing Grade III and IV neutropenia at 67.6%. So you can see that's a differentiated agent which binds the right target of beta tubulin and which can release this GEF-H1 and the key factor for DC maturation. Thank you.

That's actually very helpful. If I could just follow up with an additional question. If you look at the data that you already have in hand with regard to neutropenia, you are looking to generate a drug profile that has potential superiority to the G-CSF compounds that are out there. And I guess I want to address my question regarding the current macroscopic or political environments with regard to drug pricing. If you are even able to, which it appears you might be able to, get superior drug profile with regard to the G-CSF, with regard to, say, Grade IV neutropenias in DSN, can you comment about how you might be able to address drug pricing since that's a very sensitive issue right now, especially in the United States?

Thank you so much, Joe, for this great question. As you can see, it's a small molecule so actually we have a very low cost in manufacturing. And also, for this neutropenia prevention indication, we're only giving on day 1 out of a 21-day cycle, so very minimum dosing. So it's around 20 milligram per meter square around there. So that's probably like 40 milligrams the maximum. From that sense, our cost is very low. And then for biologics, as you know, it is seeing the very high cost arena to manufacture. So -- and in addition, plinabulin, with our very innovative and efficient drug development clinical model, so the cost for development is very low. So this way, we could give a pretty nice [indiscernible] also and a superior profile to G-CSF.

The next question is from Gabrielle Zhou of Maxim Group.

So can you -- for the 106 study design, can you walk us through and help us understand what the expected duration of neutropenia would be with Neulasta and what the delta would need to be with plinabulin to show a significant difference? What was the expected change in overall survival?

Okay. Great question. So probably I should turn this question to our Chief Medical Officer, Ramon, to answer.

Yes. Thank you. So this question relates to study 106. That's correct, yes?

Yes.

Okay. So with study 106, we will use the chemo combination of TAC. That combination was used successfully by Novartis and Sandoz to obtain regulatory approval for their G-CSF biosimilar last year. So a lot of the data and assumptions in our 106 study, they are derived from the results from that study. We also, therefore, also have the confidence that the FDA will accept this study design because they basically accepted this same design to approve the Novartis product. So from that study, we see that the DSN is around 1.5 days for the chemo combination with G-CSF. We expect to be shorter than 1.5 days. And we made several scenarios and assumptions. We made calculations based on a 50% reduction, a 40% reduction, et cetera. And based on those numbers and the -- also the assumed difference, our sample size calculations are that with only -- and 60 patients in each arm, we should have enough power to demonstrate superiority.

Great, appreciate the insights. So I have a follow-up question. And can you discuss the duration of neutropenia associated with the chemotherapy and the rates of opportunistic infection with bacteria, yeast and mold?

Yes. So the chemotherapy, of course, we have the, as we know, the important clinical consequence that we have low numbers of neutrophils. Typically, when in patients we reach the critical threshold of Grade IV neutropenia, and that's a number of around 0.5 times 10 to the 9th per liter cells. When we reach that critical threshold, from thereon, patients are very susceptible to infection. And that could be a host of infections that could lead to bacterial infections, fungal. It could be gram-positive, gram-negative. So neutropenia, as we know -- neutrophils, as we know, they are what we call our first line of defense against all microorganisms, irrespective of what type of microorganism. And it's also part of what we call the innate immune system. It means that it's there all the time and it's there to defend your body against the invasion of all these microorganisms. That's the importance of neutrophils and neutropenia, and we know that in particular in cancer patients, especially in cycle 1, we have a fairly large number of cancer patients that develop Grade IV neutropenia. And therefore, we still see a large percentage of mortality in cycle 1, also using today's standard of care. So this remains to be an important need for the medical community, and as mentioned, to maintain the right numbers of neutrophils is our prime responsibility in treating cancer patients.

The next question is from Tony Butler of Guggenheim Securities.

Lan, a couple of questions related to the clinical trials, if I may. So the trial that is with nivolumab-plinabulin, one where the University of Washington is actually the sponsor and it's being collaborated with NCI, it appears, at least according to ClinTrials, that you could get a read out -- or that could read out in September of this year. A, is that true? And B, would we actually learn that data set in the second half? And then the second question is really around DUBLIN-3, the Phase III study. And it's -- if you're enrolling 550 patients that started last year, can you give us some idea of what enrollment is to date?

Okay. Thank you, Tony. Let me answer your first question, the nivolumab and plinabulin combo at University of Washington. Yes, so the trial just started. We had a little delay with the tubing. There is a tubing issue because their tubing -- we have a certain solid [indiscernible] in our excipient. So they need to do -- we need to do leachable studies. So -- but currently it's starting. And so their projection is 2 patients [indiscernible]. The second half of this year, we'll see some preliminary data of the Phase I portion of this Phase I/II study. The Phase I portion is looking at the dose escalation of [indiscernible]. This dosing is different from the dosing from UCSD. UCSD is doing the day 1, day 8, day 15 out of 28-day cycle. And then for University of Washington is doing day 1, day 15 out of a 28-day cycle. So potentially by the end of this year, we should see the Phase I portion data from the UW study. So did I answer your question?

Ma'am, you did.

Yes, okay. So the number two question is the 103 study, which is the DUBLIN study. It's the 550-patient enrollment [indiscernible]in second-line, third-line non-small cell lung cancer. Yes, we just started last year. But because we have this large patient population from China, which has 700,000 lung cancer patients each year and we have all the major centers helping. So we are confident that we can still meet our enrollment need of 550 patients by quarter 1 of next year. Because for this 550, 440 from China and then 110 from U.S. and Australia. So currently, we have enrolled around 75 [indiscernible].

The next question is from Bruce Jackson of Lake Street Capital.

Thanks for taking my questions, most of which have been answered. I had a follow-up question about the mechanism of action trial where you demonstrated that plinabulin can promote the maturation of dendritic cells and have other positive downstream effects. Can you just speculate on whether this could be useful in combination with other types of immunotherapies like CAR T or dendritic cell therapy?

Okay. So probably, Ramon, you want to take a stab on this first? Because Ramon has over 20 years experience in the IO field.

Yes. Thank you for the question. So as we saw from the checkpoint inhibitors that we currently have on the market, they are fairly effective. However, there are still limitations, in particular, we have the phenomenon that we started high response rates and then reduced response over time. So it is clear that the checkpoint inhibitors will have to be combined with something else. The other important point to make is that if you look at the immune system, the immune system is a cascade of events. And each of these steps within this cascade is very critical to lead to an adequate immune response. Checkpoint inhibitors, they cover only one part of the cascade without covering the other parts of the cascade. What they don't cover is the DC cell, dendritic cell maturation that's very important. What we know is that the dendritic cells, they are also called antigen-presenting cells. They present the antigen to activate these T-cells and they are very critical in getting to a very powerful overall immune response. So we see therapy for plinabulin with the checkpoint inhibitors, they're also -- it's clear that there are other components in the immune system that will be the target for the next wave of immunotherapies. DC cells, that certainly is one of them, but we have all this also. The interesting component with plinabulin is that in addition to its effect on dendritic cells, it also has the ability, as we see from our preclinical studies, it has the ability to generate antigens. They're also to direct the T-cells and other immune-competent cells to the right side of action. So dendritic cells, we believe, are vastly important and important additions to the overall landscape of immune therapies. And in particular, we see the synergy between this approach and checkpoint inhibitors.

There are no further questions at this time. I would like to turn the conference back over to Lan Huang for closing remarks.

Okay. Thank you, everybody, for participating in this call. We really enjoyed all your insightful questions, and it was an enjoyable discussion. So we would like to welcome everyone to come to our presentation at the Gunnar Conference at The Mandarin Oriental on May 2. Our presentation time is 10:30 to 11 a.m. Thank you all.

Thank you. Ladies and gentlemen, this does conclude today's teleconference. You may disconnect your lines at this time, and thank you for your participation.