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Edited Transcript of BYSI.OQ earnings conference call or presentation 18-Sep-19 12:00pm GMT

Q2 2019 BeyondSpring Inc Earnings Call

NEW YORK Sep 23, 2019 (Thomson StreetEvents) -- Edited Transcript of BeyondSpring Inc earnings conference call or presentation Wednesday, September 18, 2019 at 12:00:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Dongheng Liu

BeyondSpring Inc. - CFO

* Lan Huang

BeyondSpring Inc. - Co-Founder, Chairman & CEO

* Ramon W. Mohanlal

BeyondSpring Inc. - Executive VP of Research & Development and Chief Medical Officer

* Richard J. Daly

BeyondSpring Inc. - COO

* Stephen Kilmer

BeyondSpring Inc. - Head of IR

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Conference Call Participants

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* Joseph Pantginis

H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst

* Tsan-Yu Hsieh

William Blair & Company L.L.C., Research Division - Senior Research Analyst

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Presentation

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Operator [1]

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Good day, everyone, and welcome to BeyondSpring Inc.'s Second Quarter 2019 Financial Results Conference Call. My name is Melissa, and I will be the operator on today's call. Please be advised that today's call is being recorded.

At this time, I would like to turn the call over to your host for today, Stephen Kilmer, Investor Relations. Please go ahead.

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Stephen Kilmer, BeyondSpring Inc. - Head of IR [2]

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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, market potential, collaborative initiatives and financial projections, among others. These statements are based on currently available information and management's current assumptions, expectations and projections about future events. While management believes that its assumptions, expectations and projections are reasonable in view of the currently available information, you 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 from the Investors section of BeyondSpring's website.

Joining us on today's call is Dr. Lan Huang, Chairman and Chief Executive Officer, who will begin the call and provide a brief overview; Dr. Ramon Mohanlal, Executive Vice President of Research and Development and Chief Medical Officer, who will provide a clinical update; Richard Daly, Chief Operating Officer, who will discuss BeyondSpring's marketing and partnership strategy; and Edward Liu, Chief Financial Officer, who will provide a financial update.

And it is now my pleasure to turn over the call to Dr. Huang. Lan?

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Lan Huang, BeyondSpring Inc. - Co-Founder, Chairman & CEO [3]

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Thank you, Steve. Thank you for joining the call today, ladies and gentlemen. For those of you who are new to our story, BeyondSpring is a global, clinical-stage biopharmaceutical company focused on developing transforming immuno-oncology cancer therapies to address severely unmet medical needs.

Our lead asset, a first-in-class asset, Plinabulin is in 2 Phase III global clinical programs; one as a direct anticancer agent in the treatment of non-small cell lung cancer and the other in the prevention of chemotherapy-induced neutropenia or CIN.

Since our last call, we continue to generate new data that characterize Plinabulin's unique study design and differentiated profile that further supports its potential to significantly improve cancer care. In second and third line non-small cell lung cancer with EGFR wild type, which accounts for 70% to 85% of Western patients, there are currently only 4 approved therapies available with limited survival benefit at around 8 to 10 months median overall survival and certain SAEs such as severe neutropenia. Even PD-1 antibody's response rate is around 20% and only has 2.8 months median survival benefit compared to docetaxel, the standard care in this patient population.

In CIN, the current standard of prevention care is G-CSF, such as Neulasta. However, the vast majority of patients with high-risk chemotherapy still develop grade 3 or 4 neutropenia, some over 90% after using Neulasta. Grade 3 or 4 neutropenia requires the chemotherapy dose be reduced, the next cycle be delayed, the chemo regime be downgraded or discontinued altogether. We call them the 4 Ds.

All of this results in significantly worse survival outcomes for patients. As a result, both indications present significant unmet medical need. Plinabulin has the potential to disrupt the current treatment landscape and greatly improve the overall patient outcome.

Earlier this year, we reached the first prespecified interim analysis of Study 103 for Plinabulin in the second and third line treatment for non-small cell lung cancer with EGFR wild type. After reviewing with the Data and Safety Monitoring Board, or DSMB, on the safety and efficacy data, they recommend the trial to continue.

Last year, we generated extensive data suggesting Plinabulin's potential to meaningfully improve patient outcomes in CIN when combined with G-CSF. In Study 105 and 106, data generated indicates that Plinabulin significantly reduces bone pain, prevent thrombocytopenia and reverses potential immune suppression of Neulasta.

In addition, we generated data characterizing Plinabulin's unique mechanism of action, supporting a differentiated product profile in the prevention of CIN, which appears to have a complementary therapeutic effect with G-CSF.

We view Plinabulin as a pipeline in a drug. So far, Plinabulin has treated over 560 patients with good tolerability. The foundation stage is to establish Plinabulin as an anticancer and CIN drug. We already had 4 clinical studies to confirm Plinabulin's CIN benefit and 2 clinical studies to show Plinabulin's anticancer benefit in non-small cell lung cancer.

The next stage is translation stage by combining Plinabulin with other chemo to treat additional cancer types. The transformation stage is to have triple combo of Plinabulin plus checkpoint inhibitors and chemo. This triple combo completes a perfect I/O cycle as chemo generates tumor antigens, Plinabulin induces DC maturation and activates tumor antigen specific T cells and checkpoint inhibitors let T cells kill cancer cells. We envision this triple combo could be as powerful as that of cocktail therapy for HIV.

Our regulatory strategy includes filing of NDAs for both non-small cell lung cancer and CIN in China in the first quarter of 2020 and in the U.S. in 2020. In June this year, we had an end of Phase II meeting for CIN indication and aligned with the FDA that Study 105 and 106 support a broad CIN label for all cancer and all chemo.

We also continued to strengthen our robust intellectual property portfolio. Plinabulin's monohydrate composition is now allowed in China in addition to the U.S.

A new method of use patent for Plinabulin in treating brain tumor is recently issued. Both patents are protected through 2036. The issuance of these patents further extends our proprietary rights and strengthens Plinabulin's global intellectual property position. We now have a total granted patent portfolio of 77 patents in 36 jurisdictions, including 21 issued U.S. patents with protection until 2036.

In recent months, we strengthened our balance sheet through a number of equity financings. The proceeds from these financing are to support our clinical and preclinical development and well position us to achieve the planned regulatory milestones. In addition, we are also well on track in advancing 3 preclinical immune agents BPI-002, 003 and 004 and a research platform using ubiquitin-mediated degradation pathway.

I will now turn the call to Ramon, who will discuss our recent clinical development in more detail. Ramon?

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Ramon W. Mohanlal, BeyondSpring Inc. - Executive VP of Research & Development and Chief Medical Officer [4]

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Thanks, Lan. First, I would like to provide an update on our registrational trials for our lead asset Plinabulin. 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 the second and third line non-small cell lung cancer with its primary endpoint of median overall survival. To date, we have enrolled approximately 450 patients in the U.S., Australia and China.

The study has 2 prespecified interim analysis: the first at 1/3 of patient death events and the second at 2/3 of patient death events. Earlier this year, we reached the first interim analysis and the DSMB recommended the trial to continue. The second interim analysis is expected in the fourth quarter of 2019 or the first quarter of 2020.

If the P value for the median overall survival at the second interim analysis is less or equal to 0.012, the trial may stop early. If the P value is greater than 0.012, the trial will continue and final results of the trial at a death event of 439 patients are expected to be available in 2020.

If the P value for median overall survival for final results is less than or equal to 0.046, the study can be claimed successful. The study's novel design in targeted population selection was presented at the IASLC World Conference on Lung Cancer last week.

Study 105 and Study 106 evaluate Plinabulin's effect in the prevention of chemo-induced neutropenia. 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 U.S., China, Russia and Ukraine. The primary endpoint of this trial is duration of severe neutropenia or DSN in the first cycle of chemotherapy compared to the standard of care Neulasta.

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, offering superior immune profile compared with Neulasta, having the potential to mitigate thrombocytopenia, while its unique mechanism of action potentially makes it complementary to Neulasta in preventing CIN.

In December 2018, we announced in the prespecified interim analysis the Phase III portion of Study 105 met its primary endpoint of noninferiority of Plinabulin 40 milligram fixed dose versus Neulasta 6 milligram for DSN of the first cycle. This was confirmed at the DSMB meeting chaired by Dr. Crawford, Chairman of the NCCN Guidelines for neutropenia management in the U.S. This data combined with Phase II data suggests that Plinabulin has a superior product profile and well positions us to file NDAs for Plinabulin for CIN in China in the first quarter of 2020 followed by the U.S. in 2020 with additional data from the Phase III portion of Study 106.

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 the triple combination of Taxotere, doxorubicin and cyclophosphamide in breast cancer patients. Previous top line data from the Phase II portion of this trial suggests a significant improvement in efficacy in treating CIN, a significant decrease in the percentage of patients experiencing Grade 3 or 4 CIN, more than 90% reduction in patients experiencing bone pain and reduced potential for immune suppressive phenotype when adding Plinabulin to the standard of care.

The Phase III portion of Study 106 is to compare Plinabulin at 40-milligram fixed dose combined with 6-milligram Neulasta. First, the 6-milligram Neulasta alone in the double blind study. The aim of the study is to show superiority in DSN in the first cycle as the primary endpoint. Together, this data suggests that Plinabulin offers a new approach to preventing CIN and bone pain in patients receiving chemotherapy. Less neutropenia and bone pain would enable more patients to receive a full dose of chemotherapy and complete their full chemo course, meaning that the addition of Plinabulin may meaningfully improve the current CIN standard of care and generate better patient outcomes.

Since our last call, we reported additional data supporting Plinabulin's favorable drug profile. In May 2019, BeyondSpring announced that 2 abstracts based on data derived from the Phase II portion of Study 106 were accepted for publication in the proceedings of the 2019 ASCO Annual Meeting. The first abstract concluded that adding Plinabulin to the standard dose of Neulasta offers superior CIN protection throughout the entire high-risk TAC cycle. Not only is this degree of CIN protection unachievable when using just one of these 2 agents, but the addition of Plinabulin also eradicated bone pain compared to Neulasta alone. The second abstract concluded that half dose of Neulasta combined with Plinabulin is equally effective against CIN as a full dose of Neulasta alone, demonstrating strong neutropenia benefit.

The combination therapy also offered significantly lower levels of bone pain for patients as well as favorable immune profile compared to Neulasta alone. This data suggests that the Plinabulin-Neulasta combination creates added benefits that are not seen with Neulasta alone, providing additional rationale for the use of this combination to more effectively treat CIN.

Also in May, at the International Society for Pharmacoeconomics and Outcomes Research 2019 Conference, Dr. Douglas Blayney, Global Principal Investigator for BeyondSpring's CIN development program and Professor of Medicine at Stanford University Medical Center, presented data derived from the Phase II portion of Study 105. The data demonstrated that Plinabulin has a similar efficacy profile as Neulasta in reducing docetaxel-induced neutropenia. However, Plinabulin significantly reduced patients' reported bone pain.

More recently, we announced results of a head-to-head clinical trial assessing quality of life in advanced non-small cell lung cancer patients being treated with docetaxel and either Plinabulin or Neulasta for the prevention of neutropenia in Study 105. It demonstrated that Plinabulin significantly improved quality of life over 4 cycles of treatment. Moreover, there is significant improvement in patients' quality of life in terms of fatigue, pain and insomnia. This strengthens Plinabulin's profile as an agent that is as effective as Neulasta at preventing CIN with a superior side effect profile that improves patient quality of life, in part because of its significant reduction in bone pain.

With that, I'll turn the call to Rich, who will discuss our marketing and partnering strategy. Rich?

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Richard J. Daly, BeyondSpring Inc. - COO [5]

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Thanks, Ramon. Our most recent data releases continue to support a differentiated product profile, and we believe that Plinabulin can improve the standard of care and positively affect the lives of patients with cancer, those who require prevention of neutropenia and those seeking options for the treatment of non-small lung cancer. And we continue to advance the organization toward commercialization.

This morning, I'll be addressing 3 components of our commercialization prospects: the CIN opportunity, the evolving non-small cell lung cancer market and our business development strategy that supports the excellent work of our clinical team.

First, the CIN opportunity. 4 million cycles of monotherapy G-CSF are used worldwide each year to prevent CIN today. In May of this year, Wilson and colleagues published a study in The Lancet forecasting the growth of oncology and chemotherapy regimen through 2040. Wilson stated that they expected cancer diagnoses to grow from 17 million cases worldwide to over 26 million. Additionally, the number of first course chemotherapy cycles will grow by 53% over this time from 9.8 million to over 15 million. As a result, we expect the use of supported care therapies like Plinabulin to participate in this growth.

As Lan noted earlier, there is an opportunity to improve on the standard of care and improve the outcome for patients. The clinical profile that both Lan and Ramon referred to presents a clear case for superiority in the prevention of CIN and the potential for increasing compliance and persistency with chemotherapeutic regimens with the hope that outcomes will be improved.

Our market research demonstrates the opportunity to build the case for Plinabulin as a therapy that can improve the standard of care through maintaining dose intensity and keeping patients on their scheduled dose intervals. These are critical success factors in the treatment of cancer. Even small changes in dosing or brief delays in infusions can have detrimental effects on overall survival. In fact, a 15% reduction in chemo doses can result in a 50% reduction in long-term overall survival, a devastating result.

Our proprietary market research indicates that oncologists have a very favorable response to Plinabulin's product profile. Also, physicians quickly grasp the logic of the complementary MOAs of both Plinabulin and G-CSF. The speed of onset of Plinabulin versus delayed onset of G-CSF is critical. Additionally, the superior absolute neutrophil count is also a benefit when combined with G-CSF and then the reduction in bone pain is also a benefit.

As a result, the oncologists understood the rationale for the Plinabulin plus G-CSF combination for the immediate clinical as well as the potential long-term benefits of keeping patients on planned chemotherapy regimen, dosing and cycle timing. Neutropenia is the #1 cause of changes in chemotherapy regimens. And the combination of Plinabulin plus G-CSF shows great promise in enabling the oncologist and the patient to stick to the individualized treatment plan and avoid the 4 Ds that Lan mentioned earlier.

Our goals go beyond preventing neutropenia and bone pain. We see Plinabulin's clinical benefit as a tool for providers to potentially generate better chemotherapeutic outcomes, that is provide the clinician with the opportunity to choose the most appropriate, most aggressive therapy for the patient and have the confidence that prophylaxis with Plinabulin plus G-CSF, neutropenia can be significantly reduced and patients can remain on their targeted chemotherapy.

The data generated to date by the BeyondSpring clinical team under Dr. Mohanlal's leadership has produced data that supports not only this view, but also provides intriguing insight into the potential life cycle management opportunities for the use of Plinabulin beyond non-small cell lung cancer and the prevention of CIN in chemotherapy only regimens.

Our ongoing data generation continues to give us confidence that combination therapy, that is Plinabulin plus GCSF, can become the new standard of care for prophylaxis of neutropenia. Additionally, we believe that market dynamics such as the growth of chemotherapy and the success of the combination approach, Plinabulin plus G-CSF, that CIN is a growth opportunity.

Finally, the recent success of biosimilars in the CIN space fully supports our strategy with increased choice and improved cost profile due to the biosimilar G-CSF success, the combination approach has the potential to become even more attractive to providers and payers. Plinabulin's position is straightforward. Plinabulin combined with G-CSF builds on and improves the standard of care for the prevention of CIN.

Our second topic is non-small cell lung cancer. This therapeutic area continues to evolve rapidly. The recent advancements in care with the approval of PD-1s and PD-L1s in combination with chemotherapy are indicative of the long-term importance of chemotherapy in the treatment of cancer. The advancement of I/O therapy represents a number of opportunities for BeyondSpring and Plinabulin. First, as I/O moves to first line therapy, we expect to see greater opportunities for products like Plinabulin. As Lan mentioned in her earlier remarks, the options for second and third line non-small cell lung cancer are not ideal and Plinabulin could represent a significant advancement for these patients.

Second, our early work in combination with I/O compounds may demonstrate benefits over and above that which currently is seen with I/O alone. This may represent an additional significant growth opportunity to help patients and providers struggling to address this devastating disease.

Third, as mentioned earlier, studies indicate that chemotherapy, a mainstay of cancer treatment, is expected to grow in the mid- to long term. Much of this increase in volume has been driven by the combination with newer I/O therapies. As discussed earlier, these as chemotherapy will likely give rise to CIN. Plinabulin's immunologic data generated to date demonstrates that Plinabulin unlike G-CSF does not cause immune suppression. In this therapeutic paradigm, Plinabulin could be the ideal partner for I/O therapies.

Finally, with the durable response of checkpoint inhibitors, we expect I/O chemotherapy cycles to be significantly expanded, thus creating an increased need for products like Plinabulin to be used to protect patients from CIN.

Finally, our third topic, business development. We believe Plinabulin has tremendous potential, both as a CIN and non-small cell cancer direct anticancer therapy. The data generated from our clinical programs to date support this view. Plinabulin offers a differentiated mechanism of action that's supported by clinical data and has the potential to positively affect the care of patients suffering with cancer.

The current market size for both CIN and non-small cell lung cancer, the unmet medical needs in both of these markets and the Plinabulin profile have positioned Plinabulin as an asset of interest with well-established pharma partners. Our business development strategy is to leverage Plinabulin to create the greatest value for patients, providers, payers and shareholders.

While a number of cancer cases outside the U.S. exceeds those within the borders, the majority of commercial value resides within the U.S. Consequently, we seek partners that will enable BeyondSpring to retain the greatest value here in the U.S., while enabling us to leverage partner infrastructure to launch abroad. We seek partners who can commercialize Plinabulin outside the U.S. on their own, while we retain significant rights to CIN and non-small cell lung cancer in the U.S. We are actively engaged in multiple late-stage discussions with potential partners who are aligned with our strategy. We look forward to updating you in the future on our progress.

With that, I'll turn the call over to Edward, who'll provide a financial update. Edward?

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Dongheng Liu, BeyondSpring Inc. - CFO [6]

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Thanks, Rich. I'll now briefly discuss our second quarter 2019 financial results. For greater details related to these results, I refer you to our press release issued this morning and our 6-K filing, both of which can be accessed on our website.

With that said, I'll just highlight some key numbers. R&D expenses in the second quarter of 2019 were $5.2 million compared to $11 million in the same period last year. The decrease of $5.8 million was largely attributable to a $3.9 million decrease in expenses incurred by CROs and other service fees related to clinical trials, a $1.1 million decrease in manufacturing expenses and a $0.8 million decrease in noncash share-based compensation.

G&A expenses were $2.1 million in the second quarter of 2019 compared to $1.4 million for the same quarter of 2018. The increase was mainly due to noncash share-based compensation.

Net loss attributable to BeyondSpring in the second quarter of 2019 was $7.4 million compared to $12.2 million for the same period last year.

Cash balance at June 30, 2019, were $0.7 million.

In recent months, we have strengthened our balance sheet through a number of equity financing transactions. On July 19, we closed a $35 million public offering led by Decheng Capital. The transaction attracted strong demand from high-quality U.S.-based investors and was highly oversubscribed.

In June and July, our China subsidiary entered into a series of equity purchase agreements with certain investors led by Efung Capital to acquire a 4.76% stake in the China subsidiary for approximately CNY 100 million or $14.5 million. We have so far received approximately $10 million.

In May, we put in place an ATM facility and raised approximately $30 million before it was suspended in July in anticipation of the aforementioned public offering. We believe our cash resources including the net proceeds from these financings are sufficient to support our clinical trials and submit NDAs in China for Plinabulin for the treatment of CIN and non-small cell lung cancer 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 to Lan. Lan?

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Lan Huang, BeyondSpring Inc. - Co-Founder, Chairman & CEO [7]

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Thank you, Edward. We are very pleased with the progress at our clinical development and the consistent data generated so far that further supports Plinabulin's favorable drug profile to improve cancer care.

Looking forward, we expect many important data and regulatory milestones over the next 12 to 18 months, 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 to deliver innovative medicines to the patients in need.

I look forward to keeping you updated on our progress towards this goal in the coming months. We name our company BeyondSpring with 2 meanings. First is beyond borders. We integrate U.S. and China resources together to achieve time and cost efficiencies and to target the 2 largest pharmaceutical markets in the world. This unique and scalable business model will maximize the return for our shareholders.

Second is beyond season. We like to go from the sowing and hope season of spring directly to the harvest season of NDA. As you are all aware, the harvest season or autumn is just around the corner.

This concludes our call today. Thank you, everyone, for joining.

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Questions and Answers

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Operator [1]

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(Operator Instructions) Our first question comes from the line of Andy Hsieh with William Blair.

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Tsan-Yu Hsieh, William Blair & Company L.L.C., Research Division - Senior Research Analyst [2]

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Congratulations on all the progress, Lan and the BeyondSpring team. So I have a couple. I think, Lan, you mentioned some preclinical assets, basically 002, 3 and 4. Can you provide a little bit more information about is that from the ubiquitin class or it's more similar to the Plinabulin follow-on asset?

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Lan Huang, BeyondSpring Inc. - Co-Founder, Chairman & CEO [3]

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Okay. Thank you, Andy, for the questions on our pipeline. So actually, 002, 3 and 4, they are the immune-related preclinical assets. I would like Ramon to tell you a little bit more in detail. But in addition to that, we do have ubiquitination degradation platform and that's in very advanced stage of development. And our first target is the KRAS and that's the Holy Grail target. So probably I can turn to Ramon to answer your questions on the preclinical assets.

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Ramon W. Mohanlal, BeyondSpring Inc. - Executive VP of Research & Development and Chief Medical Officer [4]

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Yes. The 002, 003 and 004 assets are immune enhancing agents. They are small molecule agents. So this is a small molecule play as opposed to biologics. 002 is a CTLA-4 like costimulator. 003 is a signaling pathway modulator. And 004 is a drug that can induce neoantigens in cancers that typically do not express enough antigen to stimulate immune system.

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Tsan-Yu Hsieh, William Blair & Company L.L.C., Research Division - Senior Research Analyst [5]

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Great. Okay. Yes, I just wanted to clarify that fact. So I also wanted to check my understanding. So you talked about the first interim look. And if I believe I -- the first interim look basically asked the question about a threshold, a hazard ratio threshold of 0.75. If it's above, then the enrollment was designed to increase to capture the full powering of the study. So is it correct to assume that at least in the first 33% of the population, you are seeing a hazard ratio of 0.75 or less? Is that a correct assumption for [ratio]?

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Lan Huang, BeyondSpring Inc. - Co-Founder, Chairman & CEO [6]

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Yes. So because -- yes, so there's no change in the design, no increase in sample size. So this is an estimate of hazard ratio equal or less than 0.75.

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Tsan-Yu Hsieh, William Blair & Company L.L.C., Research Division - Senior Research Analyst [7]

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Okay. Got it. And then about the national reimbursement review in China, I believe that happens every other year. So this year it's going to be a little bit later. So when submitting for national reimbursement review next year, is that going to be for the 2021 cycle or the 2020 cycle? I just want to get a sense of the kind of review seasonality.

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Lan Huang, BeyondSpring Inc. - Co-Founder, Chairman & CEO [8]

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Yes. So actually -- so in China, the previous years, every 8 years, they are going to do this national insurance evaluation, but now actually it's increasing the frequency of reviewing of the assets for national insurance and it will probably even be more than just every other year.

So we see agents like Tagrisso and other, actually national like China developed assets, also getting to the national insurance right after the approval. So I'm expecting that if we are so lucky to get this drug approved by 2020 or 2021, we should be able to start negotiating with the government probably right after the approval.

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Tsan-Yu Hsieh, William Blair & Company L.L.C., Research Division - Senior Research Analyst [9]

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I see. Okay. And I think I have a question for Rich about the biosimilar impact. So Amgen has this Onpro, which improves on the convenience. So with the biosimilar entry back to the market, do you see the convenience factor getting worse because patients receiving the biosimilar probably have to come back and get that shot? And do you think that's an opening for BeyondSpring to offer a more convenient product on the market?

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Richard J. Daly, BeyondSpring Inc. - COO [10]

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So I think that's a really good question. I think that this is becoming from a biosimilar and innovator, on the G-CSF side, it's becoming a pretty price sensitive market because there is no incremental innovation. The value that Plinabulin brings is incremental innovation in combination with G-CSF. So back to your point, we see Coherus having great success. They predict in their most recent announcement that they're going to end up with a 20% volume share. We see share coming down slightly for Amgen, price coming down significantly, obviously, as you see the biosimilars take share.

For us, because we are a 30-minute infusion, 30 minutes after chemotherapy on the day of chemotherapy, we think this is a pretty significant advancement and convenience, but the market research that we've done, Andy, the doctors are incredibly excited about the standard of care improvement for the patient. So we see even with Onpro, if you look at some of the data that Amgen has generated with -- they did some work with IQVIA, 200,000 cycles they did. Even with that, there's significant amount of dose delays. So patients are experiencing challenges with their chemotherapy and 25% of the patients have dose delays because of neutropenia or other issues, even with Onpro.

So we are seeing the opportunity to go in here and say we can actually improve on the standard of care and work with biosimilars or work with the innovator, the brand. So our convenience, I think, is good. The physicians in our market research respond very favorably to the convenience and for the clinic flow because obviously, the patient is there and they're in the chair already. And so we think we can have a really good story all the way around from convenience to working with biosimilars or with the innovator and then improving on the standard of care. We think we can really work all the way through the entire story.

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Tsan-Yu Hsieh, William Blair & Company L.L.C., Research Division - Senior Research Analyst [11]

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Great. And last question for me, I promise. So Edward, I think you mentioned several subsequent fundraising events. Would you mind providing us with like a rough cash balance at this moment?

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Dongheng Liu, BeyondSpring Inc. - CFO [12]

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Well, as you know, and also as we disclosed, we raised $13 million from the ATM, we raised $35 million from the follow-on offering in July and also we raised approximately $10 million from the China subsidiary offering. So that gave us approximately close to $60 million. And I think so far, we are a little bit down from there due to some payments to the vendors over the last 2 months, but this cash we think is sufficient to support both lead indications to complete the NDA both for China and U.S. So yes, I hope that answers your question.

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Operator [13]

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(Operator Instructions) Our next question comes from the line of Joe Pantginis with H.C. Wainwright.

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Joseph Pantginis, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [14]

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I have 2 questions, if you don't mind. First, regarding the upcoming interim, just a logistical question for Study 103. If you don't hit the interim P value of 0.012, as Ramon mentioned, would we expect to see a press release that's the typical continuous planned press release or would you look to provide any additional information?

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Lan Huang, BeyondSpring Inc. - Co-Founder, Chairman & CEO [15]

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Yes. Thank you so much. Joe, thanks for the question. Yes. So if we're so lucky to hit that, of course, we have to go to the DSMB and FDA and announce the good news. But if we don't, then as you know that we will just issue noticing the study is going to continue as planned.

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Joseph Pantginis, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [16]

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Okay. No. That's helpful. I just wanted to make sure. And then my second question is really wanting to -- focusing on the background activities at the companies with regard to the upcoming or expected CFDA filing in China for Plinabulin. What can you be doing ahead of data or what are you doing ahead of data with regard to the filing? Have you been able to submit anything yet? Do you have to submit it all at the same time? And then also concomitantly, what are you doing in the background with regard to potential commercialization preparations?

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Lan Huang, BeyondSpring Inc. - Co-Founder, Chairman & CEO [17]

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Thanks. So I will take the first question on the China submission, and then Rich will answer about the commercial readiness question from you. Those are all great questions. So for China, we have different rules there. As you know, October 2017, China government actually issued this 36 rule to really promote innovation and also to target this cancer -- this severely unmet medical need indication for the population.

So what they say is for those life-threatening diseases, including late-stage cancers, the companies can do rolling submission of the NDA and they can use interim data with efficacy trend to submit and then the government will give conditional approval based on the efficacy trend. And then later, of course, the company has to finish the whole study and get to the final look. And then if it still supports the approval, then the government will give approval.

So this is how we follow with the current strategy. So as you see that for the CIN study, for the 105 Phase III interim, we did announce last December that we need the interim analysis to have statistical significance, DSMB has also agreed with that. And also, we have from the 106 Phase II top line, we have superior data.

So both of them will enable us to submit for the China conditional approval for the CIN. And then as you see for the non-small cell lung cancer, we do have a pretty positive interim analysis in the first look, right? Hazard ratio of 0.75 is tremendous, right? Even with nivolumab versus docetaxel in this severely unmet medical need population, there's hazard ratio of 0.73. And for ramucirumab plus docetaxel, the approval was only -- there's hazard ratio of 0.86, right? So that's a very encouraging trend in efficacy that enable us to also do the rolling submission. So far, we haven't submitted yet, but that's why in our press release as we say quarter 1 of 2020 because there's a lot of things going on for the submission package for the CMC, we're done. For the preclinical, we are also done. But also to write CSR and other things, it does take time. So -- okay. So Rich will answer the commercial readiness question.

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Richard J. Daly, BeyondSpring Inc. - COO [18]

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Thanks, Joe. So philosophically, we are aligned between the U.S. and China. So between the 2 countries, the global amount of G-CSF units is 66% of the global utilization of G-CSF. So while price is significantly better obviously from previous statements we've made from the company, 75% of the global value is in the U.S., but China is growing at a 33% clip on a dollar basis. So we believe there's tremendous value and tremendous opportunity in China not only because of the volume of cancer cases, but obviously because of the G-CSF growth and the opportunity to improve care for patients who are suffering with cancer in China. So our goal is to hold onto as much value in these 2 critical markets as possible.

With that said, we want to be smart about entering China. We want to be really thoughtful about it because obviously, it's a very complex market. Also taking into consideration the size of the market, but the concentration of cancer care. Cancer care in China is concentrated basically into 5 cities. So one does not have to cover -- I should say, a company does not have to cover the entire country to cover cancer care.

So we're working right now on the BD front to identify, and we are in deep discussions with companies who can -- top companies who can actually cover these markets and are experienced in these markets, cancer market specifically, but -- so giving you the back and forth on it, the most recent capital raise we had in China gives us great confidence that we can be a very strong negotiation partner with these companies.

So we are looking at creating again as much value as possible for our shareholders by holding onto as much of long-term value for the asset as possible. What we don't want to do is get into a situation where China continues to grow and we've outlicensed at a very low residual. So we are looking to make sure we get the best partner possible. It is complex. I want to be really clear, we -- not necessarily first order of priority to build an infrastructure in China on the back of one molecule. However, we believe that the P&L can support a product like Plinabulin because we believe price will be relatively healthy, and cost of goods is solid, it's a very good cost of goods. And cost of sales will be very light compared to other products. And especially with the concentration of care in China, we think this is a really good opportunity for us or for our partner as we think about entering to China. So our discussions are advanced in China, and we believe we are a very strong negotiation adversary or partner there as well. So we're looking for the best value possible and the quickest entry given the time lines that Lan has discussed in the past.

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Operator [19]

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Ladies and gentlemen, that concludes our question-and-answer session. I'll turn the floor back to management for final comments.

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Lan Huang, BeyondSpring Inc. - Co-Founder, Chairman & CEO [20]

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Well, thank you so much for joining the call today and your continued interest and support of BeyondSpring. Have a nice day.

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Operator [21]

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