BeyondSpring Inc.
Q3 2019 Earnings Call Transcript

Published: 18 Dec 2019

[Operator:]

Good day everyone and welcome to BeyondSpring’s Third Quarter 2019 Conference Call. My name is Rob and I’ll be your operator on 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 David Schemelia, Senior Vice President at KCSA Strategic Communications.

[David Schemelia:]

Thank you, operator and thank you everyone for joining today's call. I would like to advise listeners 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 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 current 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 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's 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. Huang. Lan?

[Lan Huang:]

Thank you for joining today’s call. Thank you, David. For those of you who are just now starting to follow our story, BeyondSpring is a global biopharmaceutical company focused on the development of transforming immunooncology cancer therapies for unmet medical needs. The last quarter had been very exciting with a few significant milestones achieved.First, our lead asset, first-in-class agent, Plinabulin is on-track to file an NDA for non-small cell lung cancer and the prevention of chemotherapy induced neutropenia or CIN indications in China and in the U.S. in the next 6 to 18 months. Leading with the filing in China for CIN around Quarter 1, 2020.Second, with Plinabulin validated as a potent inducer for Antigen Presenting Cells or APC inducer was recent publications in Cell Journals, Plinabulin has the potential to future indications with triple combo combining with PD1 or PDL1 antibodies and chemo or radiation for multiple cancer indications.Last, but not the least, Plinabulin’s recent U.S. patent granted in brain tumors as to its robust patent portfolio of 75 granted patents in 36 jurisdictions with protection to 2036, including composition for matter patent. Thus, we have a very long patent runway to realize Plinabulin’s clinical and commercial potential.Since our last update, we continue to progress in our clinical studies. In October, we reported that the first patient was enrolled in the company’s Study 106, a global Phase 3 clinical trial with Plinabulin in combination with G-CSF to prevent CIN, designed to show superiority in CIN and bone pain control compared to G-CSF alone.As you know, G-CSF is the standard-of-care for CIN for the last 30 years with annual sales over $7 billion globally. In addition, I’m very pleased to report that after 5 years of effort collaborating with leading scientists at University of Basel and Massachusetts General, we have uncovered Plinabulin’s unique mechanism in cancer treatments and in CIN control.Plinabulin’s anti-cancer in new mechanism as a potent agent to induce dendritic cell maturation and T-cell activations were published in the prestigious peer-reviewed Cell publications, Chem and cell reports in September.Recently, Plinabulin’s mechanisms in CIN control by reversing chemo-induced bone marrow suppression, and its effects in reducing CIN of multiple chemo was different mechanism was published in cancer chemotherapy and pharmacology this month. This paper further validates what we have observed in human studies in Plinabulin’s durable anti-cancer benefit and in CIN control with multiple chemo and synergizes with G-CSF.On the financing side, in late October, we completed a public offering significantly expanding our institutional shareholder base and strengthening our balance sheet as we advance our clinical pipeline towards NDA submissions in the U.S. and China. So, as you see it has been a very busy few months for BeyondSpring. All in all, we view Plinabulin as a pipeline in a drug.To date, Plinabulin has treated more than 580 patients with good tolerability. The fundamental indications of Plinabulin are in non-small cell lung cancer and in CIN with multiple clinical studies confirming Plinabulin’s benefit some with high statistical significance. Both of the second and third-line non-small-cell lung cancer and the CIN indications are severely unmet medical needs indications.First, in patients with second and third line non-small cell lung cancer who are EGFR wild type, which accounts to 85% of Western patient, there are very few approved therapies available, and current treatment options have a modest medium OS or overall survival rate of 8 to 10 months, but as expense of severe adverse events such as severe neutropenia and quality of life. Even response rate with PD1 inhibitor mono-therapy is around 20% with a median survival benefit of only 2.8 months, compared to Docetaxel, the standard-of-care in this patient population.Secondly, in CIN, the current standard-of-care is G-CSF monotherapy with a long-lasting version Neulasta being the market leader. However, after using Neulasta, about 90% of patients with high-risk chemotherapies still develop grade 3 or 4 neutropenia. Grade 3 or 4 neutropenia requires the chemotherapy dose to be reduced, the next cycle be delayed, the regime to be downgraded or be discontinued altogether. So, we call this the four d’s, all of which result in significantly reduced survival outcomes for patients.Thus, we're very confident Plinabulin has the potential to disrupt the current treatment landscape and greatly improve overall patient outcomes and quality-of-life. Our regulatory strategy is submitting NDAs in China for CIN in the first quarter of 2020 and for non-small cell lung cancer in the second half of 2020. We also plan to submit NDAs in the U.S. for CIN in the second half of 2020 and for non-small cell lung cancer in the first half of 2021.This staggered NDA filing strategies for both China and the U.S. allows agencies in both countries to sufficiently review the Plinabulin’s pre-clinical safety and CMC sections while we submit for the NDA for the CIN indication. And when it comes to the submission for the non-small cell lung cancer indications since the same pre-clinical and the CMC sections of Plinabulin submissions have being reviewed, we expect the review and approval process will be much accelerated.Such an approach has been adopted by FibroGen with its innovative first-in-class asset, which successfully obtained regulatory approval in China first with a speedy timeline ahead of the U.S. approval. In November of this year, we had a successful pre-NDA meeting with the U.S. FDA and reached alignment that our current safety data needs requirements for the NDA filings for both indications of Plinabulin.We believe Plinabulin’s transforming potential in triple combo of combining Plinabulin, PD1 or PDL1 antibodies and radiation or chemotherapy for the treatment of multiple cancer types. This triple combination approach optimizes utility of immunotherapy as radiation or chemotherapy generates tumor antigen Plinabulin’s DC maturation in fact optimizes presentation of this tumor antigen to cytotoxic T-cells and checkpoint inhibitors enabled activated T-cells to kill cancer cells.In other words, Plinabulin steps on the gas, PD1 releases the break. So, this triple combination approach could be a powerful cocktail that resembles the powerful HIV cocktail therapy, which transformed HIV from a [death] disease to a chronic disease with patients having normal life expectancy.In addition, we remain on track to advance three pre-clinical immune agents, BPI-002, BPI-003, and BPI-004 and a research platform using ubiquitin-mediated degradation pathways to Nobel Prize winning technology, which can target 70% of [indiscernible] target, as we have award-leading team working on this.Now, I'm turning the call over to Dr. Ramon Mohanlal who will discuss our recent clinical development in more detail.

[Ramon Mohanlal:]

Thank you, Lan. First, I would like to provide an update to our registrational trials for our lead asset Plinabulin. First, non-small cell lung cancer Study 103, is a 554 patient Phase 3 registrational study, evaluating the anti-cancer effects of Plinabulin in combination with Docetaxel, compared to Docetaxel alone in second and third-line non-small-cell lung cancer, with its primary endpoint of median overall survival.To date, we have enrolled approximately 480 patients in the U.S., Australia, and China. The study has two pre-specified interim analysis. The first, when one-third of the patient’s [death] is reached; and the second when two-thirds of the patient [death] are reached. Earlier this year, we reached the first interim analysis and the Data and Safety Monitoring Board or DSMB recommended the trial to continue with no change to the protocol specified number of patients.Final results of the trial at a [death rate] of 439 patients are expected to be available in the second half of 2020. Second, studies 105 and 106 evaluates Plinabulin’s effect in the prevention of chemotherapy induced neutropenia. We have aligned with U.S. and China FDA that 105 and 106 studies would support a broad CIN label for all cancers, all chemo’s, and to be combined with G-CSF.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 U.S., China, Russia, and the Ukraine. 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, improved quality of life, offering a superior immune profile compared with Neulasta, and having the potential to mitigate thrombocytopenia.Plinabulin’s non-G-CSF based unique mechanism of actions potentially makes it complimentary to Neulasta in presenting CIN. In December last year, we announced in the pre-specified interim analysis, the Phase III portion of Study 105, met its primary endpoint of non-inferiority with Plinabulin at a 40-milligram fixed dose versus Neulasta at 6-milligram for DSN in the first cycle.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 a triple combination of taxotere, doxorubicin and cyclophosphamide in breast cancer patients.Previous top line data from the Phase II portion of this trial suggests; firstly, a significant improvement in efficacy in treating CIN; secondly, a significant decrease in the percentage of patients experiencing Grade 3 or 4 CIN; thirdly, more than 90% reduction in patients experiencing bone pain; and lastly, a reduced potential immune suppressive phenotype, when adding Plinabulin to the standard of care.The Phase III portion of Study 106 will compare Plinabulin at the 40-milligram fixed dose, combined with 6-milligram Neulasta versus 6-milligram of Neulasta alone in a double-blind study. The intent of the study is to show superiority in DSN in the first cycle, as a primary endpoint. We have already enrolled the first patient in this study in October. The data generated to-date suggest that Plinabulin offers a novel approach to preventing CIN and bone pain in patients receiving chemotherapy.Minimizing neutropenia and bone pain would allow more patients to receive a full dose of chemotherapy and complete their chemotherapy treatment implying that the addition of Plinabulin to G-CSF has the potential to significantly improve the current CIN standard of care, resulting in better anti-cancer outcomes and patient's quality of life.Positive clinical results of Plinabulin have been accepted for presentation at world-leading conferences. In late September and early October, we presented two posters at ESMO. The first poster focus on the Novel Trial Design for Study 103 and its success compared with the failed Javelin Lung 200 trial.Researchers surmise that the open label design of Javelin, first, the single blinded Study 103 trial attributed it to Javelin failure, as patients dropped out of the study prior to receiving the first dose. The second poster evaluated in Study 106, the effects of Neulasta combined with Plinabulin on absolute neutrophil and platelet counts and measured the frequency of thrombocytopenia.Our data show that the combination appears to have a superior product profile, often Neulasta in CIN control, platelet counts, and bone pain. Additionally, we recently presented two e-publications on Study 105 at ASH, highlighting Plinabulin's ability to protect hematopoietic stem cells, which differentiates into neutrophils and all the white blood cell types. The mechanism of action pre-clinical [paper] is consistent with this message.Lastly, BeyondSpring presented the poster at ASH on Study 106, which provides rationale for the addition of Plinabulin to Neulasta, due to their complementary mechanism of action for the Prevention against chemotherapy, to achieve synergy.With that, I'll now turn the call over to Rich, who will discuss our commercial and partnership strategy.

[Richard Daly:]

Thanks, Ramon. As you heard, our clinical data continues to support our belief that Plinabulin can improve the standard-of-care and positively affect the lives of cancer patients. Those who require the prevention of chemo-induced neutropenia and those seeking innovative new options in the treatment of non-small cell lung cancer. To that end, we are working diligently to advance our organization toward commercialization on both fronts.As we await additional clinical readouts in 2020, the upcoming year holds immense promise for the company and potentially for the patients and providers we hope to serve. First, will address CIN. Recently published data and Lancet forecast continued growth of chemotherapy from 9.8 to 15 million cycles between now and 2040, a 53% increase.We share this growth-oriented view of the opportunity in CIN. As mentioned earlier, CIN continues to persist despite the use of G-CSF and cause clinicians to change or reduce dose of patients through the regimens, which can have devastating effects on anti-cancer outcome.In fact, CIN is the most frequent cause of change for chemotherapy regimens. Our clinical program and recently completed proprietary market research tells us that Plinabulin used together with G-CSF has the potential to play a major role in both improving the standard of care and benefiting the patient's quality of life.Even small changes in chemotherapy doses or brief delays in chemotherapy infusion can have detrimental effects on overall survival. Just a 15% reduction in chemotherapy doses can result in a 50% reduction in overall survival. This fact is not lost on oncologists. In fact, upon learning about the benefits of Plinabulin, plus G-CSF combination therapy in blinded market research, 65% of doctors and KOLs we interviewed were excited of the prospect of treating patients with Plinabulin.It's clear doctors are receptive to new treatment options for CIN and understand there is a high unmet medical need in the market. Our market research and clinical research continues to build the case for Plinabulin, as a therapy that can improve the standard of care in cancer therapy. By developing Plinabulin to work with and to enhance G-CSF therapy, the goal is to allow [HCP's] to avoid the four D’s mentioned earlier, and provide stable chemotherapy doses, sustained chemotherapy cycles, and the strongest chemotherapy regimens.Moreover, our proprietary market research continues to indicate that oncologists are favorable towards the Plinabulin product profile and physicians quickly grasp the logic of the complementary mechanisms of action of both Plinabulin and G-CSF. This means the speed of Plinabulin’s onset versus the delayed onset of G-CSF, the superior absolute neutrophil count and the reduction of bone pain.The Plinabulin plus G-CSF combination shows tremendous promise in enabling oncologist and their patients to adhere unabated to the individualized treatment plan and avoid the four Ds. Additionally, our goals go beyond preventing neutropenia and bone pain. We see Plinabulin's clinical benefits, as a way for providers to potentially generate better chemotherapeutic outcomes, empower oncologists to choose the most appropriate, most aggressive therapy for patients, and have confidence that neutropenia can be significantly reduced and patients can remain on their targeted chemotherapy.Our ongoing data generation both clinical and market research continues to give us confidence that combination therapy that is Plinabulin plus G-CSF can offer an improved standard of care. Additionally, we believe that market dynamics such as the growth of chemotherapy and the success of the combination approach highlights CIN the growth opportunity.In short, the combination approach is proving to provide a number of benefits for clinicians, patients and payers, including significantly reduced neutropenia, with the goal of avoiding the 4 Ds, and driving a stable, sustained cycle with the strongest doses of chemo, and improved bone pain profile to ensure enhanced therapeutic experience, and the potential for greater persistency, and clinical data that suggests anti-cancer activity.Our clinical data validates a clearly differentiated product profile and our market research indicates a clear and compelling market need for new therapies to improve the standard of care in CIN.Now transitioning to non-small cell lung cancer. Non-small cell lung cancer is one of the most exciting therapeutic areas in all of medicine today and continues to evolve rapidly. Advances in the care with the approval of IO therapies for first line creates a need for new options in second and third-line therapy, the advancement of IO therapy presents a great opportunity for BeyondSpring, Plinabulin, and patients.Plinabulin’s clinical data to-date in our non-small cell therapy lung cancer program demonstrates the promise as an effective agent in second and third-line therapy. Given a [dose of] effective options for patients at this advanced stage, we are excited about the prospects of delivering clinically meaningful data and results for patients with Plinabulin for non-small cell lung cancer.As we consider lifecycle management for Plinabulin, we look to our early work in combination with IO compounds. It is our hope that we may demonstrate benefits over and above that which is currently seen with IO alone. This may represent an additional significant growth opportunity to help patients and providers struggling to address this devastating disease.Now, moving onto business development. We believe Plinabulin has tremendous potential as a CIN and non-small cell lung cancer – anti-cancer therapy. As mentioned earlier, our most recent market research with over 100 HCPs, as well as payers, gives us confidence that the data we have generated to-date demonstrate a differentiated product profile.Additionally, receptivity of these oncologists and payers, the profile is indicative of an unmet market need. We see these responses echoed in our business development efforts with great interest coming from potential partners, as we prepare for upcoming data inflection points, we are well positioned to maximize the value Plinabulin both here in the U.S. and abroad, through our go-to-market strategies.A recent ZS study showed that 7 out of 10 companies launching their first oncology product in U.S. went to market on their own, due to the potential strength of the U.S. P&L. While 70% partnered in Europe for both CIN and non-small cell lung cancer, the U.S. represents more than 75% of the global value, and we are prepared to optimize this value through our business development and commercialization efforts. We look forward to updating you on our progress as we go forward.In closing, our clinical profile is excellent and fills a clear unmet need in the market. We have the potential to set a new standard of care. Our market research indicates HCP's recognize that Plinabulin is a differentiated product with significant clinical potential. HCP's are also excited about the opportunity to use Plinabulin in the prevention and treatment of CIN, to keep patients on the most appropriate, most aggressive came up every regimen.As we prepare to file NDAs for Plinabulin in China and the U.S. for CIN and non-small cell lung cancer, our U.S. and global commercialization plans are aligned with our development and regulatory timelines. We are taking steps to ensure BeyondSpring can bring Plinabulin to market, so that we optimize the benefits for patients, providers, and shareholders.With that, I'll now turn the call over to Edward, who'll provide a financial update. Edward?

[Edward Liu:]

Thanks, Rich. I'll now briefly discuss our third quarter and 2019 financial results. For greater details related to these 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'll now highlight some key numbers. R&D expenses in the third quarter of 2019 was $7.2 million, compared to $14.1 million in the same period last year. The decrease of $6.9 million was largely attributable to a $3.9 million decrease in CRO expenses and other service fees related to clinical trials, a $0.5 million decrease in pre-clinical trials and a $0.5 million decrease in non-cash share-based compensation.G&A expenses were $2.5 million in the third quarter of 2019, compared to a $1.5 million for the same quarter of 2018. The $1 million increase was mainly due to a $0.7 million market research expense incurred during the quarter. Net loss attributable to BeyondSpring in the third quarter of 2019 was $9.4 million, compared to $14.9 million for the same period of last year.Our cash balance at the end of Q3 was $24.7 million. Subsequent to the third quarter, on October 24, we successfully completed a $25.8 million follow-on equity offering. The transaction was led by Decheng Capital, and attracted strong demand from high quality U.S.-based institutional investors.This transaction together with the financing in July continue through significantly improve the liquidity of our stock. With our strength in balance sheet, we are confident that our current cash resources are sufficient to support our clinical trials and submit NDAs for Plinabulin for the treatment of CIN and non-small cell lung cancer in both the U.S. and China, and to advance our immuno-oncology pipeline, as well as our ubiquitination protein degradation research platform.With that, I will now turn the call back over to Lan for the conclusion. Lan?

[Lan Huang:]

Thank you, Edward. As you can tell, 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 which combines anti-cancer and the CRM prevention potential.Looking ahead, we expect many important data and the 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 the patients in severely unmet medical needs, all over the world. I look forward to keeping you updated on our progress towards that goal in the coming months.We have integrated U.S. and China resources to achieve time and cost efficiency in the two largest pharmaceutical markets in the world. We believe that this unique and scalable business model will maximize the return for our shareholders. To those of you, who have been on this journey with us, we want to thank you for your trust and your support, to those new to our mission 2020 promises to be an exciting year, as we anticipate NDA filings for Plinabulin in both the U.S. and China in the near future. We look forward to continue this journey with you.Thank you for your attention, and now I'm turning this back to the operator.

[Operator:]

Thank you. [Operator Instructions] Our first question is coming from the line of Joe Pantginis with H.C. Wainwright. Please proceed with your questions.

[Joe Pantginis:]

Hi, good morning everyone, thanks for taking the question. Lan, since you guys have such unique inroads into the Chinese market, based on your relationships there, and things like the 1000 Talent Award, 1000 Talent Innovator Award et cetera. I was just curious, your status of your discussions with both the CFDA and the Chinese government with regard to both things like pricing and reimbursement and manufacturing. And as part of that question, what remains outstanding other than data for you to deliver the NDA?

[Lan Huang:]

Thank you so much, Joe, and thank you for your continued support and belief in our company, and also in Plinabulin. So, yes, thanks for this great question. So, as you see, that not only I do have the – 1000 Talent Award from the government, but also, we – Plinabulin also has [indiscernible] from the Chinese government, and that basically is the most important innovation grant from the State government. And that does give us the regulatory speed and in the expedited review and also later to be potentially included in the national insurance.One example for the speedy review is, for our CIN indication, we received the CTA for Phase III initiation from CFDA within one month, after package submission, which is really a historical record because most of those approval takes one year to two years. So, as you see that, we do have continued discussion with the CFDA regarding the submission readiness of our package, and as you see from the – our target, we are on track to submit quarter one of 2020, and currently for the manufacturing, we do use CMOs in China to manufacture for the China domestic, NDA filing.And so that's check and a clinical trial data [actually] current details, as always, I said is, 105 Phase 3 interim plus the 106 Phase II data is supporting submission. And so those are set. And for the safety database, that's set because we have already had 580 patients treated was Plinabulin's. The safety database is only 300. And also, the quality for the trials has been checked. So, those actually have all the data ready to be submitted. And, but then you had a question regarding the pricing, and then potentially getting to the insurance system. So, we probably can use FibroGen as a significant example, right?So, FibroGen does have this innovative first-in-class anemia drug, and – got China FDA approval first, recently in the beginning of the year, and then you ahead of the U.S. approval and that was a speedy approval after all data is two months, afterwards, it was approved. And then secondly, it just recently got into the national insurance, it was a very good pricing, because it is the only drug in the category. So, you can see that Plinabulin potentially could also follow similar steps like FibroGen, which has set very, very good example for us. And as you know, actually Dr. Peony Yu, who is the Chief Medical Officer of FibroGen, she is our SAB Board.

[Joe Pantginis:]

Great. Thank you very much for that. Very helpful and happy holidays, everyone.

[Lan Huang:]

Thank you.

[Operator:]

Thank you. [Operator Instructions] The next question is from the line of Andy Hsieh with William Blair. Please proceed with your question.

[Andy Hsieh:]

Great, thanks for taking my questions and congratulations on all the progress. So, I have a question on the Phase 3, 103 trial, the Dublin-3 trial. So, it seems like that timing has been pushed back a little, is it due to the slower-than-expected event rate. I'm just curious about what you're seeing there?

[Lan Huang:]

Yes, probably I can start and then Ramon can add other details. So, as you see from Ramon's discussion, we have enrolled over 480 patients, out of the 554 patients. So, enrollment is as planned, but of course this is event-driven study, right? So, we have to wait until that event is reached. So, if the event is not reached then, the timeline gets pushed. So, that was the reason, nothing to do is the study conduct or anything, everything is going as planned.

[Ramon Mohanlal:]

Yes. This is Ramon. Thank you, Lan. I have nothing to add. This is an event-driven trial. So, we have to let the data play out and the events, they are collected as we go and that determines timelines.

[Andy Hsieh:]

Got it, okay. And there is really no visibility to which Arm is really causing the delay?

[Lan Huang:]

We don't know, it's blinded to us, right. We cannot do any analysis until the interim – right So, but also in a way is – if our [indiscernible] slowly, slower than it's better, but this is – we cannot see that data, as you see, but this is a great question.

[Andy Hsieh:]

Yes, okay. And so – for in terms of the patent you discussed, which is great. So, for the – I think it was one of the polymorph patents that goes out to 2036. Is that eligible for extension. I think there is a clause that allows for extension, given the regulatory review and also the R&D. So, basically the question is, is 2036, the worst-case scenario or that's with extension?

[Lan Huang:]

Yes. So, thanks for this great question, because the pattern runway is very important to realize Plinabulin's potential. So, this 2036 is the exact date of the expiration for that monohydrate patent, which it is – even though it's a polymorph, but is – we did get a [composition matter] patent, only this API can be used for the drug product manufacturing. So, this is a very strong pattern.So, actually what you related to, yes, there is a potential five-year extension on the pattern we choose right, and currently from the – or the other rules with U.S. FDA, we do – we are eligible for this maximum of five year extension because our patent lawyer did do all the calculations on this, how the delays in the clinical trial and also the review time. So, that could get us to 2041 potentially. So, this is – this even give us more runway for Plinabulin.

[Andy Hsieh:]

Oh, great. Well.

[Lan Huang:]

And then also for China, actually the same thing. Chinese government is also putting together patent linkage system, and also potentially can also extend for a few years, because in EU and Japan and the U.S. all have this patent extension. China is in the process implementing this. And in China, this monohydrate pattern has been granted, as well.

[Andy Hsieh:]

I see. Got it, okay. Yes, that's great news. And thanks for the explanation. And that's all I have. Congratulations again.

[Lan Huang:]

Thank you so much for your support.

[Operator:]

Thank you. At this time, we have come to the end of our question-and-answer session. I will turn the floor back to management for any final comments.

[Lan Huang:]

Well, thank you so much for your valuable time and your continued support. Please have a nice day and happy holidays.

[Operator:]

Thank you. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.