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BeyondSpring Inc. (BYSI 8.53%)
Q3Â 2019 Earnings Call
Dec 18, 2019, 8:00 a.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
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 -- Senior Vice President
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 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 Investor Section of BeyondSpring's website.
Joining us on today's call is Dr. Lan Huang, BeyondSpring Chairman and Chief Executive Officer; Dr. Ramon Mohanlal, Executive Vice President of Research, 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. Lan?
Lan Huang -- Co-founder, Chairman and Chief Executive Officer
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 immuno-oncology 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 US in the next six to 18 months, leading with the filing in China with CIN around quarter one 2020.
Second, with Plinabulin validated as a potent inducers for Antigen Presenting Cells or APC inducer with recent publications in Cell Journals, Plinabulin has the potential future indications with triple combo combining with PD-1 or PD-L1 antibodies and chemo or radiation for multiple cancer indications.
Last but not the least, Plinabulin's recent US patent granted in brain tumors as to its robust patent portfolio of 75 granted patents in 36 jurisdictions with protection to 2036, including composition of 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 Study 106, a global Phase III clinical Trial with Plinabulin in combination with GCSF to prevent CIN, designed to show superiority in CIN and bone pain control compared to GCSF alone. As you know, GCSF 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 five years of efforts, collaborating with leading scientists at University of Basel and Mass General, we have uncovered Plinabulin's unique mechanism in cancer treatment and in CIN control. Plinabulin's anticancer immune mechanisms work as a potent agent to induce dendritic cell maturation and T-cell activation were published in the prestigious peer-reviewed Cell publications, Chem and Cell Reports in September. Recently, Plinabulin's mechanism in CIN controlled by reversing chemo-induced bone marrow suppression and its effects in reducing CIN of multiple chemo with different mechanism was published in Cancer Chemotherapy & Pharmacology this month. These papers further validates what we have observed in human studies in Plinabulin's durable anti-cancer benefits and CIN control with multiple chemo and synergizes with GCSF.
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 toward NDA submissions in the US and China. So as you see, there has been a very busy few months for BeyondSpring.
Owing 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.
Most of the second and third-line non-small cell lung cancer and CIN indications are severely unmet medical needs indications. First, in patients with second and third line non-small cell lung cancer with EGFR wild type, which accounts to 85% of Western patients, there are very few approved therapies available. And current treatment options have a modest medium OS or overall survival rate of eight to 10 months, but as expense of severe adverse events such as severe neutropenia and quality of life. Even response rate with PD-1 inhibitor monotherapy 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 GCSF monotherapy with a long-lasting version Neulasta being the market leader. However, after using Neulasta, about 90% of patients with high-risk chemotherapy still develop grade 3 of 4 neutropenia. Grade 3 or 4 neutropenia requires the chemotherapy dose to be reduced. The next cycle to be delayed, the regimen to be downgraded or be discontinued altogether. So record is 4 Ds, all of which result in significantly reduced survival outcomes for patients. Thus we are 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 US 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 US allows agencies in both countries to sufficiently review the Plinabulin pre-clinical safety and CMC sections while we submit for the NDA -- for the CIN indications.
And when it comes to the submission for the non-small cell lung cancer indications, it's the same pre-clinical and the CMC sections of Plinabulin submissions have been reviewed, we expect to review and approval process will be much accelerated. Such a 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 US approval.
In November of this year, we had a successful pre-NDA meeting with the US FDA and reached alignment that our current safety data needs requirement for the NDA filings for both Indications of Plinabulin. We believe Plinabulin's transforming potential in triple combo of combining Plinabulin, PD-1 or PD-L1 antibodies and radiation of 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 effect optimizes presentation of this tumor antigens to cytotoxic T-cells and checkpoint inhibitors enabled activated T-cells to kill cancer cells. In other words, Plinabulin steps on the gas, PD-1 releases the brake. So this triple combination approach could be a powerful cocktail that resembles a powerful HIV cocktail therapy, which transformed HIV from a deadly 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, the Nobel Prize winning technology which can target 70% of [Indecipherable] target as we have a world-leading team working on this.
Now, I'm turn the call over to Dr. Ramon Mohanlal who will discuss our recent clinical developments in more detail.
Ramon Mohanlal -- Executive Vice President, Research and Development, Chief Medical Officer
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 III registrational study, evaluating the anticancer 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 US, Australia, and China. The study has two pre-specified interim analysis. The first, when one-third of the patients death is reached and the second, 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, Study 105 and Study 106 evaluates Plinabulin's effect in the prevention of chemotherapy-induced neutropenia. We have aligned with US and China FDA that 105 and 106 studies would support the broad CIN label for all cancers, all chemos and to be combined with the GCSF. Study 105 is a Phase II/III registrational trial of Plinabulin after the standard regimen of docetaxel in advanced breast cancer, hormone refractory prostate cancer, and advanced non-small cell lung cancer patients in the US, China, Russia, and the Ukraine. Previous data from the Phase II 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-GCSF based unique mechanism of action potentially makes it complementary to Neulasta in preventing 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 topline data from the Phase II portion of this trial suggests; firstly, the 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 GCSF 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 has 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. Research surmise that the open label design of Javelin, first, the single blinded Study 103 trial attribute it to Javelin failure, as patients dropped out of the study prior to receiving their first dose. The second poster evaluated in Study 106, the effects of Neulasta combined with Plinabulin on absolute neutrophil and platelet counts and measure the frequency of thrombocytopenia. Our data show that the combination appears to have a superior product profile, often Neulasta in CIN control, platelet count 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 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.
Rich Daly -- Chief Operating Officer
Thanks, Ramon. As you heard, our clinical data continues to support our belief that Plinabulin can improve the standard of care 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, let me address CIN. Recently published data and Lancet forecast continued growth of chemotherapy from 9.8 to 15 million cycles between now in 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 GCSF and caused 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 GCSF 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 GCSF combination therapy in blinded market research, 65% of doctors and KOLs we interviewed were excited at 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 GCSF therapy, the goal is to allow HCPs to avoid 4Ds mentioned earlier and provide stable chemotherapy doses, the same chemotherapy cycles and the strongest chemotherapy regimens. Moreover, our proprietary market research continues to indicate that oncologists are favorable toward the Plinabulin product profile and physicians quickly grasp the logic of the complementary mechanisms of action of both Plinabulin and GCSF. This means the speed of Plinabulin's onset versus the delayed onset of GCSF, the superior absolute neutrophil count and the reduction of bone pain, the Plinabulin plus GCSF combination shows tremendous promise in enabling oncologist and their patients to hear unabated to the individualized treatment plan and avoid the 4Ds.
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 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 GCSF 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 as 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 4Ds, 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 promise as an effective agent in second and third-line therapy. Given our 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 life-cycle 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 seeing 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 needs. 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 US 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 US went to market on their ow due to the potential strength of the US P&L. While 70% partnered in Europe for both CIN and non-small cell lung cancer, the US represents more than 75% of the global value, and we are prepared to optimize 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 HCPs recognize that Plinabulin a differentiated product with significant clinical potential. HCPs 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 chemotherapy regimen. As we prepare to file NDAs for Plinabulin in China and the US for CIN and non-small cell lung cancer, our US 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 Dongheng Liu -- Chief Financial Officer
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 done, 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 24th, we've successfully completed a $25.8 million follow-on equity offering. The transaction was led by Decheng Capital and attracted strong demand from high quality US-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 US 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 -- Co-founder, Chairman and Chief Executive Officer
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 toward that goal in the coming months.
We have integrated US 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 US 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.
Questions and Answers:
Operator
Thank you. At this time, we will be conducting a question-and-answer session. [Operator Instructions] Our first question is coming from the line of Joe Pantginis with H.C. Wainwright. Please proceed with your questions.
Joseph Pantginis -- H.C. Wainwright & Co, LLC -- Analyst
Hi, good morning everyone, thanks for taking the question. Lan, since you guys have such a unique inroads into the Chinese market, based on your relationships there, and things like the 1000 Talent Award, 1000 Talent Innovator Award etc. 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 -- Co-founder, Chairman and Chief Executive Officer
Thank you so much, Joe and thank you for your continued support and belief in our company and also in Plinabulin. So yeah, thanks for this great question.
So as you see, that not only I do have the 1000 Talent Award from the government, but also Plinabulin also has this 13th five-year grant 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 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 are -- 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 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 data current details, our -- as always, I said it wild Phase III interim plus the wild 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 with Plinabulin's, the safety database is only 300. And also the quality -- for the trials has been check. So those are -- actually have all the data ready to be submitted. And by then you will have a question regarding the pricing, and then potentially getting insurance system. So we probably can use FibroGen as the significant example, right. So FibroGen does have this innovative first-in-class anemia drug. And in regard to China, FDA approval first, recently in the beginning of the year and then ahead of the US 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 a very, very good example for us. And as you know, actually Dr. Peony Yu, who is the Chief Medical Officer of FibroGen, she is on our SAB Board.
Joseph Pantginis -- H.C. Wainwright & Co, LLC -- Analyst
Great. Now, thank you very much for that. Very helpful and happy holidays, everyone.
Lan Huang -- Co-founder, Chairman and Chief Executive Officer
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 -- William Blair & Company L.L.C. -- Analyst
Great. Thanks for taking my questions and congratulations on all the progress. So I have a question on the Phase III 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 -- Co-founder, Chairman and Chief Executive Officer
Yeah. 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 -- Executive Vice President, Research and Development, Chief Medical Officer
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 -- William Blair & Company L.L.C. -- Analyst
Got it, OK. And there is really no visibility to which arm is really having the delay?
Lan Huang -- Co-founder, Chairman and Chief Executive Officer
We don't know, it's blinded to -- we cannot do any analysis until the interim, right So but also in a way is -- if our arm -- slowly, slower than it's better, but this is -- we cannot see the data, as you see, but this is a great question.
Andy Hsieh -- William Blair & Company L.L.C. -- Analyst
Yes, OK. 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 -- Co-founder, Chairman and Chief Executive Officer
Yeah. 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 compulsory for a 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 or the other rules with US FDA, 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 even give us more runway for Plinabulin.
Andy Hsieh -- William Blair & Company L.L.C. -- Analyst
Great.
Lan Huang -- Co-founder, Chairman and Chief Executive Officer
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 US 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 -- William Blair & Company L.L.C. -- Analyst
I see. Got it, OK. Yeah, that's great news. And thanks for the explanation. And that's all I have. Congratulations again.
Lan Huang -- Co-founder, Chairman and Chief Executive Officer
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 -- Co-founder, Chairman and Chief Executive Officer
Well, thank you so much for your valuable time and your continued support. Please have a nice day and happy holidays.
Operator
[Operator Closing Remarks]
Duration: 42 minutes
Call participants:
David Schemelia -- Senior Vice President
Lan Huang -- Co-founder, Chairman and Chief Executive Officer
Ramon Mohanlal -- Executive Vice President, Research and Development, Chief Medical Officer
Rich Daly -- Chief Operating Officer
Edward Dongheng Liu -- Chief Financial Officer
Joseph Pantginis -- H.C. Wainwright & Co, LLC -- Analyst
Andy Hsieh -- William Blair & Company L.L.C. -- Analyst
