Categories Earnings Call Transcripts, Health Care

BeyondSpring Inc. (BYSI) Q2 2020 Earnings Call Transcript

BYSI Earnings Call - Final Transcript

BeyondSpring Inc. (NASDAQ: BYSI) Q2 2020 earnings call dated Sep. 03, 2020

Corporate Participants:

Scott Eckstein — Vice President

Lan Huang — Co-Founder, Chairman & Chief Executive Officer

Richard J. Daly — Chief Operating Officer

Edward Dongheng Liu — Chief Financial Officer

Ramon Mohanlal — Executive Vice President, Research and Development and Chief Medical Officer


Maury Raycroft — Jefferies — Analyst

Joe Pantginis — HC Wainwright — Analyst

Andy Hsieh — William Blair — Analyst



Good morning, and welcome to BeyondSpring’s Second Quarter 2020 Financial Results Conference Call. My name is Kevin, and I will be your operator for today’s conversation. [Operator Instructions].

At this time, I would like to turn the call over to Scott Eckstein, Vice President at KCSA Strategic Communications. Scott, please go ahead.

Scott Eckstein — Vice President

Thank you for joining today’s call.

I would like to advise listeners that comments made during today’s call may reflect forward-looking statements that are related to such matters as BeyondSpring’s clinical and preclinical research and development activities and results, regulatory and commercial plans, industry trends, market potential, collaborative initiatives, and financial projections, among others. While management believes that its assumptions, expectations and projections are reasonable in view of the currently available information, you are cautioned not to place undue reliance on these forward-looking statements. The company’s actual results may differ materially from those discussed during this call for a variety of reasons, including those described in the forward-looking statements and Risk Factors sections of the company’s 20-F and in other filings with the SEC, which are available on the Investors section of BeyondSpring’s website.

Joining us on today’s call is Dr. Lan Huang, BeyondSpring Co-Founder, Chairman and Chief Executive Officer; Dr. Ramon Mohanlal, Executive Vice President, Research and Development and Chief Medical Officer; Richard Daly, Chief Operating Officer; and Edward Liu, Chief Financial Officer.

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

Lan Huang — Co-Founder, Chairman & Chief Executive Officer

Yeah. Thank you so much, Scott. Good morning, ladies and gentlemen, thank you for joining today’s call.

BeyondSpring’s mission has been to develop innovative, transformative medicines that improve clinical outcomes in high unmet medical needs for the global market. With our lead asset, first-in-class agent Plinabulin in late stage developments in two large oncology market opportunities for chemotherapy-induced neutropenia or CIN prevention and non-small cell lung cancer treatment, we believe that we are at a significant inflection point that will potentially result in helping many patients in need and realizing tremendous value for our shareholders. This is the combination of 10 years of hard work at BeyondSpring with our dedicated and experienced team and our partners, globally.

In addition, we have a developing clinical and preclinical pipeline with plinabulin in multiple I/O combo cancer indications, three preclinical I/O agents and world leading targeted protein degradation, TPD platform to fuel future growth. Dr. Hershko, Nobel prize winner in the field is our scientific advisor.

Finally, we have developed global capabilities through strong clinical and regulatory network and developing commercial infrastructure to drive ongoing innovation. For Plinabulin’s first indication, CIN, we expect to file NDA to the US FDA by the end of 2020. We have initiated rolling NDA submission for China NMPA in quarter one, 2020. CIN indication has only one drug G-CSF approved in the last 30 years. G-CSF class, which has annual revenue of over $9 billion globally and over $7 billion in the US alone.

Even with the use of G-CSF, cancer patients undergoing chemo still experiencing over 80% of Grade 4 neutropenia or very low white blood cells, which will cause severe infections leading to death and the need to reduce or delay chemo dose or downgrade chemo regimes in later cycles. All of this affect chemo’s anticancer benefit. Therefore, CIN is still a severely unmet medical need.

Since our first IND meeting with the US FDA in September 2016 and the first patient enrolled in the US in April 2017, we had enrolled around 500 patients in the CIN study to arrive at this significant NDA filing by the end of the year.

Along the four year journey, Dr. Blayney and Dr. Crawford, US CIN, NCCN guideline founding member and former Chairman have been guiding us for the trial design and trial quality. Plinabulin and G-CSF combination has been shown to be superior in CIN prevention in our clinical studies, which would potentially translate to reduce infection and hospitalization after chemotherapy, and enable doctors to provide chemotherapy to their patients without compromise. This means, stable doses, sustained cycles, and the strongest regimes possible so that patients can stay the course with their treatment for potential survival benefit.

Now, let me share with you some detailed clinical and preclinical achievement in the second quarter of 2020. First, the positive top line prespecified interim Phase III data from our PROTECTIVE-2 or Study 106 continues to support the superior profile of using Plinabulin in combination with Neulasta, versus using Neulasta alone for protection against CIN and demonstrate the potential of the Plinabulin and G-CSF combination to become the first superior therapy and significant enhancement to G-CSF in preventing neutropenia in all chemo and/or non-myeloid cancer in the last 30 years.

I’m also excited to report to you that the enrollment of a total of 221 patients involved in Phase III study has been completed in July, ahead of schedule. And we expect top line Phase III data will be available in quarter four, 2020.

Second, our DUBLIN-3 Trial or 103 Study achieved another major milestone, the second interim analysis for non-small cell lung cancer treatment with Plinabulin. As you may recall, DUBLIN-3 is a global Phase III trial for Plinabulin in combination with docetaxel versus docetaxel alone, for the treatment of second and third line EGFR wild-type non-small cell lung cancer and Plinabulin’s mechanism based measurable lung lesion targeted patients. This is a highly unmet medical need indication as only four therapies have been approved with limited survival benefits and come with the ability to fight it back, such as over 40% severe neutropenia.

Upon reviewing the efficacy and safety data of more than 500 patients and at around 300 patient death events, the DSMB recommended that the trial continue without any modification based on favorable benefit risk ratio. We think that the positive trend seen in two interim analysis is expected, justified by Plinabulin’s I/O mechanism in activating immune defense protein GEF-H1 and positive Phase II subset analysis based on mechanism targeted patients. We look forward to the final top line data for first half of 2021 at 439 test events.

Third, at the AACR meeting in June, we presented data on triple I/O and Plinabulin combo, demonstrating 100% complete response rate in PD-1 nonresponsive tumor models conducted at MD Anderson. We plan to start triple I/O and Plinabulin combo study at MD Anderson in second half 2020 with the intention to reverse progressive disease of previous PD-1 antibody failed patients. This potential success of the study will showcase Plinabulin’s potent activity in antigen presenting cell or APC induction, serving as a potential cornerstone therapy in cancer treatment. This study will set the stage for Plinabulin as a pipeline in the drug for multiple cancer indications.

Finally, we believe the foundation for an innovative company is patents and talents. For Plinabulin, the composition matter patent and the multiple usage patent are protected through the year 2036 in 36 jurisdictions, including 17 granted patents in the US. This gives substantial runway for Plinabulin to realize its commercial potential as a pipeline in a drug. And while company — we made some significant additions to our world class management and our Board of Directors in this quarter.

In August, BeyondSpring announced the appointment of Paul Friel to the role of Chief Commercial Officer. Paul has nearly 30 years of experience in the pharmaceutical and biotech industry and successfully launched over 12 drugs. He has held positions as General Manager and President at Takeda Canada and Vice President of Sales for Vyaire. Paul was also instrumental in building TAP Pharmaceuticals and Takeda, North America to more than 5,000 employees and $10 billion in sales in less than 10 years during the merger of these companies. We’re very excited about this appointment and look forward to pose continued contribution in his new role to help our company transform from R&D to R&D and C.

Also in August, Dr. Ravi Majeti, Co-Founder and former Board member of Forty Seven, and Chief of Division of Hematology at Stanford University joined our Board of Directors. Dr. Majeti co-founded Forty Seven in 2014 and was a major contributor to the research and technology that led to Forty Seven’s $4.9 billion acquisition by Gilead Sciences this past March. With his extensive background and experience, Dr. Majeti can help guide us to translate [Indecipherable] clinical data to medicine for patients and well deserved shareholder value. We look forward to his contributions as an invaluable new member of our Board.

In summary, after 10 years of hard work of researching Plinabulin’s unique mechanism and enrolling over 1,000 patients, we have a clearer understanding of Plinabulin’s clinical profile and development trajectory. In the next six to 18 months we expect significant clinical and NDA catalyst, which will drive BeyondSpring’s transformation into a commercial stage company.

With that, I will now turn the call over to Dr. Ramon Mohanlal, who will discuss our recent clinical developments in more detail. Ramon? Thank you, Lan. Firstly, I will talk about the CIN program. In the past five years, we have brought the CIN program to fruition. And as Lan indicated, we are very proud to announce that even as we speak, we are preparing the CIN NDA. The [Indecipherable] trial PROTECTIVE-2, which is now fully enrolled is nearing its completion. This is a transformational time for us with the company’s first NDA filing. We had a number of discussions with the FDA, who proactively contributed to our study designs and reviewed all our protocols prior to enrollment. We have had in-depth discussions with the FDA regarding changing the primary endpoint from DSN to the more meaningful endpoint of rate of Grade 4 neutropenia prevention. At the pre-planned interim analysis of PROTECTIVE-2, we have met not only the new primary endpoint of Grade 4 neutropenia prevention, but also met the criteria for the old endpoint of DSN. In anticipation of the final data set of PROTECTIVE-2 we now have started the preparation of the CIN NDA, which will also include data from PROTECTIVE-1 and other trials with neutropenia data with Plinabulin to include studies 101, 103 and 105. With the combined data set we believe we have the data points needed to satisfy the efficacy and safety requirements, as well as other sections as required by the NDA. The collective data set provides very strong support for adding Plinabulin to pegfilgrastim. Due to different mechanisms of action, the two drugs are complementary to each other, wherein Plinabulin predominantly provides protection in the first week of the cycle and pegfilgrastim predominantly in the second week of the cycle. Combining these two agents provide superior CIN protection compared to each of them alone. Together, these two agents also come with a more favorable safety profile. Hence, it will make sense that every time an oncologist prescribes pegfilgrastim or G-CSF they should consider adding Plinabulin to that. The indication we are targeting is very broad to include all chemo therapies and all non-myeloid cancers. As mentioned earlier, we believe our collective clinical trial data set has all the data points required to support the CIN NDA submission, which is planned around December of this year. Combined, we have collected data in more than 1,200 patients, of which, more than 700 patients had been dosed with Plinabulin. Now, I will move to the non-small cell lung cancer update. We recently had our DSMB for the second pre-planned interim analysis. We are in the DSMB not only to review the safety data in an open session, but also the efficacy data in a closed session to determine benefit risk of the Plinabulin docetaxel combination. Based on the review, the DSMB recommended the trial to continue without modification. We feel that as very positive and are currently moving ahead with completing patient enrollment, which we expect will occur this year. Just as with all pharmaceutical companies, COVID-19 did impact and continues to impact our timelines. However, we believe the impact will be minimal, since we are at the tail end of the trial. The final data analysis will be triggered by reaching the target event number of 439 death cases achieved that we expect in the first half of 2021. I would like to further remind you of the following. First, Plinabulin’s unique anticancer mechanism of lead in GEF-H1 as we validated in the Cell Reports paper. Second, in our Phase II study we showed an OS benefit of 4.6 months and HR for OS at 0.76 in our target population of having a measurable lung lesion RECIST criteria in the lung. Three, in the first pre-planned interim analysis of the Phase III trial 103 in around 150 patients death events, we showed a positive trend of an OS of HR less than 0.75. Four, the target product profile of the Plinabulin, docetaxel combination is — demonstrates superior efficacy, superior safety and superior quality of life of standard of care in second and third line, which is now dominated by those cell regimens. With the current standard of care in second and third line, we achieved improved survival. However, at the expense of safety, this more toxicity and at expensive quality of life. With the Plinabulin, docetaxel combination, not only do we expect superior efficacy over docetaxel alone, we also have reduced toxicity and have improved quality of life. We believe the Plinabulin, docetaxel combination has the potential to become the market leader in second and third line non-small cell lung cancer. As a reminder, approximately 50% of non-small cell lung cancer patients will have to see progression with a checkpoint inhibitor regimen in first-line and this will be a need of a second-line treatment option. The Plinabulin, docetaxel combination will be an ideal treatment option for these patients. Now, I will provide a R&D update. I will start with CIN. The current focus is on non-myeloid cancers as Plinabulin, pegfilgrastim combination strategy, and we envision that Plinabulin will be added to pegfilgrastim or G-CSF every time these agents will be used. From a medical perspective, we see only upside and no downside. Superior CIN protection and without added toxicity and likely with less toxicity. We estimate this combination product will target approximately 75% of the CIN market. There are significant market segments where currently G-CSF is not indicated for use or is listed in the warnings and precautions section of the product label. These segments include hematological malignancies and conditions such as sickle cell disorder. These are market segments that we will now start to address. Next, I’ll move to oncology. Our future direction will focus on triple combination strategies in first-line, wherein we will have an agent that can generate immunogens. This could be a chemo or radiotherapy, Plinabulin as a dendritic cell enhancer and a PD-1, PD-L1 inhibitors. Proof of concept of this triple combination strategy with Plinabulin has presented at the AACR 2020. Currently preparations are underway to initiate a number of these trials. Regarding our pipeline, we continue to advance our preclinical programs BPI-002 and BPI-004. I will now take the opportunity to update you on our medical affairs activities in support of the commercial effort. In response to the COVID-19 pandemic, the National Comprehensive Cancer Network, NCCN, recently updated its guidelines to maximize CIN prevention. This is intended to minimize patients’ potential exposure. We recently initiated an Expanded Access Program, EAP, which allows doctors across the US to use Plinabulin for CIN prevention. We are proud to do our part in helping others during the Pandemic and believe that initiating this program will assist patients and healthcare systems to meet the challenges that have been imposed on them by the current COVID-19 environment. We have initiated a broad outreach and awareness efforts with Plinabulin in CIN. CME [Phonetic] programs have been initiated. KOL Advisory Board meetings have commenced. We have initiated discussions with the NCCN. We have increased our presence and sponsoring at influential scientific meetings. We are initiating a number of IIT studies for CIN and cancer indications with leading cancer centers in the United States. Publication strategy. Our Plinabulin Phase II CIN data has recently been accepted for publication in a major journal, which we view as an important external validation. Additional manifests are in preparation, targeted at major journals. We had clinical abstracts accepted at ASCO, ISSCR and ESMO. In summary, during the second quarter of this year, we continued to advance our CIN and non-small cell lung cancer program. And as discussed, we are now getting ready to bring these programs to fruition with the CIN NDA application this year and the non-small cell lung cancer NDA application next year. In support of our commercial preparation, we have initiated broad medical affairs driven outreach and awareness efforts and have continued advancing our pipeline program. With that, I will now turn the call over to Rich who will discuss our commercial and partnership strategy. Rich?

Richard J. Daly — Chief Operating Officer

Thanks, Ramon. As we’ve discussed, our clinical program is robust and continues to generate both strong and compelling data for the potential role that [Indecipherable] cancer care. I’d like to add my congratulations to our clinical team. We are incredibly excited about the opportunity to improve cancer care for patients. Equally encouraging, our extensive market research has shown oncologists are excited about Plinabulin’s potential, clinical benefits to their patients.

Today, I’ll discuss three elements that drive our excitement. First, the unmet clinical need; second, the changing market forces in oncology; and third, Plinabulin’s commercial strategy for a successful launch. During our discussion, I’ll be referencing our ongoing market research that supports our strategy.

First, the unmet need in CIN is significant and recognized. With more than 1.3 million cycles of G-CSF given each year, the CIN market remains an unserved market. CIN is the number one reason for changes in chemotherapy regimens. These changes take the form of decreased doses, delayed cycles and discontinuation of chemotherapy. Even modest changes in chemotherapy regimens have potentially devastating effects on patient treatment outcomes. In our market research, oncologists were crystal clear as to the importance of preventing CIN. Three quarters of oncologists said it was very to extremely important to prevent CIN.

Monotherapy G-CSFs are current standard of care, but they are simply not enough to prevent and manage CIN. This is where Plinabulin can become a game changer. In our market research, more than 100 practicing oncologists told us the three most important characteristics of CIN therapy were: one, keep absolute neutrophil count, or ANC as high as possible; two, reduce or minimize bone pain; three, improve compliance and persistency with chemotherapy. In other words, avoid the four Ds. As you heard earlier, this is the clinical profile of Plinabulin.

Oncologists want a therapy that can help them provide more consistent, sustained chemotherapy. Our goal is to provide them with the tools to flip the four Ds to the four Ss through improved management and control of CIN, a therapy that will help them provide stable doses, sustained cycles, the strongest regimen possible and help them to stay the course.

The vast majority of oncologists, 74% are enthusiastic about a combination therapy approach with Plinabulin. When we asked the same 100 oncologists how likely they are to use Plinabulin in combination with the G-CSF, nearly two-thirds or 64% stated they were highly likely to use the combination therapy. Clearly oncologists are looking for an improvement in the standard of care.

Our second topic, the changing market forces in oncology. The CIN market is undergoing significant changes, which strongly favored Plinabulin’s introduction and long-term prospects. The pandemic is driving a desire for more effective therapies beyond monotherapy G-CSF.

Next, the addressable market expansion. As Ramon mentioned, earlier we referenced the NCCN guidelines and their update in CIN. The guidelines expanded prophylaxis from high-risk patients, which accounts for 32% of chemotherapy patients to both high and intermediate-risk patients, which now accounts for 69% of all chemotherapy patients. This is an increase in the addressable market of more than 100%.

The next change in oncology is the clinical pathway. Oncology practices use Clinical pathways to standardize care while adhering to evidence based guidelines. Clinical pathways have the potential to improve the effectiveness and efficiency of care. The majority of practices base their clinical pathways on NCCN guidelines.

Next, CIN use concentration. G-CSFs are highly concentrated, 360 oncology accounts represent more than 80% of G-CSF use. This is among the most highly concentrated businesses in oncology. So, how does these factors help us build the Plinabulin strategy? Based on the clinical data we generated, our market research and current oncology market trends, we believe that Plinabulin, a medication that improves therapy by combining with the standard of care is well positioned to improve patient care and for successful commercialization.

A recent ZS study found that 70% of companies similar to BeyondSpring, those that are oncology focused, launching their first product are likely to launch on their own in the US. This is due to the relative strength that oncology products have on their P&L statements. That is favorable pricing, low cost of goods, and focused cost of sales. We have already initiated our pre-launch activities to prepare us for success in the market. Importantly, this will enable us to optimize shareholder return as we explore partnership opportunities.

So our commercial strategy involves five core components. First, we will be driving awareness over the next 12 months with top payers, key opinion leaders and physicians through educational outreach. Second, as Ramon mentioned, we’ll be building the case for guideline adoption. We believe that Plinabulin data presented earlier by Lan and Ramon, represents a significant advancement in the standard of care in preventing CIN. Based on this, we believe we are well positioned for inclusion in updated NCCN guideline. NCCN submission is being prepared and we will be ready prior to FDA approval per NCCN submission recommendations.

Third, account and customer outreach. As a combination therapy that builds on the standard of care, Plinabulin is unique in the field. No other product on the market or in development has the potential to make this claim. We want to be sure that customers are aware of our clinical program.

To give you a sense of the concentration and magnitude of the opportunity and why we are confident we can execute this plan, let’s look at the value of the top accounts. As noted earlier, 80% of all G-CSF use comes from 360 accounts. This is a highly concentrated opportunity, one that a company like ours can focus on and win. Further, the top 50 accounts represent $1.2 billion of G-CSF use and the top 100 accounts represent $1.8 billion of G-CSF use.

Recall that in market research, oncologists had a very favorable response; Plinabulin combined with G-CSF. High users of G-CSF had an even more favorable response to using Plinabulin and were more inclined to use the combination. Since Plinabulin is used in combination with G-CSF, the perfect target list for us is the G-CSF use. Our outreach has already begun.

Fourth, ensuring insurance coverage and access. In our market research, more than 90% of payers told that they plan to include Plinabulin in their formularies per NCCN guidelines due to its ability to improve the standard of care. Payers understand Plinabulin is a unique molecule, one that creates value in combination with G-CSF, and payers indicate that they were treated as such in contracting and formulary discussions. To ensure appropriate reimbursement, we plan to launch a field reimbursement liaison team from day one.

Finally, healthcare practitioners and patient commercial support. Over the next year, leading up to and through launch we will deliver a fully integrated market preparation and launch program to support the successful launch of Plinabulin. Elements include, our seasoned commercial launch team and leadership team who are experienced in building and scaling organizations, as well as launching products and leading partnerships. We are prepared for all alternatives.

We will execute a well defined and targeted pre-launch market shaping program to prepare the market for the launch of Plinabulin. Some of the key elements include, large account outreach, NCCN guideline outreach, as mentioned earlier, disease awareness, key opinion leader development, speaker mobilization, physician education, both CME and non-CME, Congress support, medical symposia, publications, as Ramon mentioned, and targeted advisory boards. Once approved, we’ll deliver launch support to drive rapid appropriate uptake of Plinabulin. And this would include, 60 to 80 sales representatives to drive pull-through and broad oncologist and payer coverage, a field reimbursement team to ensure effective reimbursement, as I mentioned earlier, and that would be from day one, and patient support services to ensure ease of use, broad access, and improved care with patient education and copay support programs.

In summary, only Plinabulin has demonstrated the ability to clinically complement the standard of care and improve ANC, reduce Grade 4 neutropenia, reduce bone pain, and give oncologists the tools they need to enhance treatment outcomes. Plinabulin’s clinical performance, along with the evolving medical needs to the oncology community bode well for the successful launch and long-term commercial success of our drug. In summary, Plinabulin is delivering on the promise of elevating chemotherapy.

With that, I’d like to turn it over to Edward, who’ll provide a financial update. Edward?

Edward Dongheng Liu — Chief Financial Officer

Thank you, Rich. I’ll now briefly discuss our second quarter 2020 financial results. For greater detail related to these results, I’ll refer you to our press release issued this morning and to our 6-K filing, both of which can be accessed under the Investors section of our website. With that said, I will now highlight some of the key numbers.

R&D expenses in the second quarter of 2020 were $11 million, compared to $5.2 million in the same period last year. The $5.8 million increase was largely attributable to a $4.9 million increase in clinical trial expenses.

SG&A expenses were $2.6 million in the second quarter of 2020, compared to $2.1 million for the same quarter of last year. The $0.5 million increase was mainly due to the increase in cost related to pre-launch preparation of Plinabulin.

Net loss attributable to BeyondSpring in the second quarter of 2020 was $12.8 million, compared to $7.4 million for the same period last year. Our cash and cash equivalents at the end of Q2 was $38.1 million. We are confident that our current cash resources are sufficient to support our clinical trials and NDA submission in the US for Plinabulin for the CIN indication, as well as to advance our immuno-oncology pipeline and protein degradation research platform.

As Lan noted earlier, in June and July we closed a public offering and a private placement at $13 per share and raised gross proceeds of $33.9 million. These transactions have continued to strengthen our balance sheet and diversified our shareholder base. We intend to use the net proceeds to support the commercialization of Plinabulin, continue clinical and preclinical development, and for general corporate purposes.

With that, I’ll now turn the call back over to Lan for closing remarks. Lan?

Lan Huang — Co-Founder, Chairman & Chief Executive Officer

Thanks, Edward. In closing, I would like to thank the patients, our dedicated team, our shareholders and our partners for your strong support in helping us to deliver innovative medicines that can potentially provide superior results than the current standard of care to patients across the world with severely unmet medical needs. This is especially important during the COVID-19 era as our healthcare system is experiencing unprecedented challenges.

Looking ahead, in the next six to 18 months, BeyondSpring will be transforming into a commercial stage company through multiple significant clinical and NDA catalysts. We welcome you to embark on this exciting and meaningful journey with us as we help many patients in need.

Operator, let’s open for question-and-answers. Thank you.

Questions and Answers:


Thank you. We will now be conducting a question-and-answer session. [Operator Instructions] Our first question today is coming from Maury Raycroft from Jefferies. Your line is now live.

Maury Raycroft — Jefferies — Analyst

Hi, good morning, everyone, and congrats on the progress. And thanks for taking my questions. I guess first question is just on the — if you could talk more about the NCCN guidelines submission prep for CIN? Any thoughts on timing and when you might submit? And when the guidelines could get updated? And once updated, I was wondering if you plan on pursuing named-patient use in reimbursement?

Lan Huang — Co-Founder, Chairman & Chief Executive Officer

Yeah. Thank you so much Maury for this great question. I think I’ll let Rich to start and Ramon probably add a few more insights. Rich, please.

Richard J. Daly — Chief Operating Officer

Sure, thanks. Thanks for the question, Maury. So the guidelines are pretty clear and they are posted on the NCCN website. You can — it’s basically a simple process, it’s a two page application, so very straightforward. And you can apply up to six weeks prior to your approval and the meetings for each Advisory Committee are scheduled in advance. However, they will, if necessary, as they did with COVID-19 call an emergency meeting and if they deem that the opportunity represents a significant advancement. So for instance, the next meeting is at middle of October — next scheduled meeting is in the middle of October.

So as Ramon talked about, we’ve begun our preparation and we understand the process and we are fully prepared for the opportunity to get on those guidelines.

So with that, I’ll turn it over to Ramon, obviously, for any type of named-patient program or further commentary on the NCCN guidelines.

Ramon Mohanlal — Executive Vice President, Research and Development and Chief Medical Officer

Yes. Thanks, Rich. As we speak, we have started discussions with the NCCN leadership. And as Rich pointed out, those are the timelines that we will follow. Thank you.

Maury Raycroft — Jefferies — Analyst

Got it. And is it possible to potentially get reimbursement for use ahead of an official approval?

Richard J. Daly — Chief Operating Officer

That’s a really good question. So that’s a payer question more than a NCCN question. But payers will follow, obviously, the label. They’ll look at the label. NCCN, again, on their website is very clear that they will actually go outside of label. They’ll do what they think is in the best interest of the patient. And then the payers have told us and we’ve done extensive research with payers. We’ve talked to more than 40 regional and national payers and they told us that NCCN is the thing that they will — that will drive their policy and their priorities for what they will reimburse. So they’ll look at the label first and then they will look at NCCN. And cancer, obviously, is one of those areas where they’re really interested in making sure they’re not seen as blocking therapy, they want to be sure that they are seen as very patient friendly, especially if something is devastating as cancer.

So it’s obviously a very sensitive situation with cancer side. We can’t really address each payer or the payer space in total prior to approval. So that’s just a difficult question. I think that’s a payer-by-payer question. And we really haven’t addressed that at this point in time.

Maury Raycroft — Jefferies — Analyst

Got it. Okay. And then for non-small cell lung cancer, can you provide more granularity into how much the timeline shifts are related to COVID versus that event rate or other contributing variables?

Lan Huang — Co-Founder, Chairman & Chief Executive Officer

Yeah. So, probably I can start and then Ramon can add additional insight. So, yeah, actually COVID-19 does impact the timeline because everybody gets affected. But I think it is minimal since we are doing global enrollment. And also just for China, I think after March everything seemed back to normal, not like in the US. So it’s not really much impacted.

As you see from Ramon’s presentation, the 439 patient death event, which is the full event is going to be expected for the first half of next year. And we are closing almost at the end of the — finishing off the enrollment, the full enrollment, this year.

Maury Raycroft — Jefferies — Analyst

Got it. Okay. And then last question is just — if you can talk more about the CIN label expectations. I guess have you had any discussions with FDA to see if they will accept the use of Plinabulin in combination with all other G-CSFs broadly? And do you see any potential boundaries for what Plinabulin can be combined with?

Lan Huang — Co-Founder, Chairman & Chief Executive Officer

Yeah. So, probably I can start and then Ramon can add additional insights. So, for the label discussion, of course, this has to wait until the pre-NDA meeting, which we are planning in the coming months. And from where we are seeing from the Plinabulin profile and also what’s the missing link for the G-CSF, we do project a broad label for Plinabulin and G-CSF combination in all myeloid cancer and with all chemo and also can be combined with the G-CSF class. The reason being that no matter what chemo, what cancer it is — and CIN is a bone marrow problem, right? So — and from all the literature, if you look at it, even with the use of G-CSFs, no matter what cancer, what chemo, they always have ANC model between day six and day eight. Because it takes eight days to mature neutrophil and G-CSF is given on day two. So all of the new neutrophils coming out, mature ones is after day eight or day nine, right? And Plinabulin’s mechanism is protecting the first week and it has been shown in multiple cancer and multiple chemo.

So with that profile, the complementarity of the two agent is going to protect the full cycle, no matter what cancer — no matter what chemo it’s going to use. And in addition, G-CSF class is all the same, right? And they will approve the biosimilar G-CSF based on DSN of those — Neulasta or Neupogen. So we don’t see much differences in the G-CSF class versus Neulasta, which is what we’re using in the clinical study. So that’s a long answer. So I don’t know if I answered your question.

Maury Raycroft — Jefferies — Analyst

Yeah. That’s helpful perspective. Okay. Thanks for taking my questions.

Lan Huang — Co-Founder, Chairman & Chief Executive Officer

Yeah. Thank you.


Your next question today is coming from Joe Pantginis from HC Wainwright. Your line is now live.

Joe Pantginis — HC Wainwright — Analyst

Good morning, everyone. Thanks for taking the question and thanks for all the color thus far, especially coming up ahead of very nice catalyst for the company. I really have a logistical question that I think is targeted more towards Edward, and that’s looking at the burn and potential offsets that we should consider. So obviously, some of these Phase IIIs are — the Phase IIIs are winding down, so you’re going to have a significant drop in clinical trial costs there. But then are we anticipating any significant boost in, say, personnel costs or how should we view the burn going forward and potential offsets?

Edward Dongheng Liu — Chief Financial Officer

Right. Thanks, Joe for this question. So, as you know, we had about $38.1 million at the end of June 30. As we said in the press release, that’s sufficient for CIN submission in the US and we currently project the CIN submission by the end of this year. So I think our current cash will last for the next three quarters or so. As you will see, the clinical expenses will be largely reduced compared to the previous quarters. As you correctly pointed out, the clinical trials are coming down to an end. However, the commercial cost will start to increase over the next several quarters. And as well as headcount as we prepare the organization ready for a commercial launch.

So I guess we are projecting about a burn of around $15 million — $15 million every quarter going forward. However, we will need additional cash for the commercialization towards the end of next year in preparation for commercial launches towards the end of next year.

Joe Pantginis — HC Wainwright — Analyst

Perfect. Thanks for that color.

Edward Dongheng Liu — Chief Financial Officer

Thank you.


Thank you. [Operator Instructions] Our next question today is coming from Andy Hsieh from William Blair. Your line is now live.

Andy Hsieh — William Blair — Analyst

Excellent. Thanks for taking my questions. So I have a couple. One is more just kind of housekeeping. Any update on PROTECTIVE-1. I think you — on the call you talked extensively about PROTECTIVE-2 and it’s excellent data from — looking from a clinical profile — efficacy clinical profile perspective. So, any update on that?

And second, I think it’s really interesting that you are allowing expanded access to Plinabulin just given the fact that it’s probably closest thing to real world experience prior to approval. Maybe some commentary on that, motivation behind that and maybe early feedback from participated physicians or institutions? And maybe kind of a related question for Rich. How do you think about potential revenues from the expanded access program? And I have a follow-up after these.

Lan Huang — Co-Founder, Chairman & Chief Executive Officer

Yeah. Thank you so much, Andy, for the great questions, and thank you for your support all along. If I can just answer — the quick answer for the PROTECTIVE-1 and then Ramon will answer on the EAP, and then Rich will answer for your revenue question. So for the PROTECTIVE-1, our interim analysis for the first 105 patients has completed, I think last year, right. And we had a press release at the end of 2018 showing that we did meet the statistical significance for the primary endpoint in showing the DSN non-inferiority for Plinabulin versus Neulasta alone. So these things were going forward with the combination label for G-CSF and Plinabulin. So for the PROTECTIVE-1 as a monotherapy it’s a supportive study for this label. So — and it has also shown the first week early onset mechanism of Plinabulin in multiple cancer types. So that study is basically complete to be the supportive trials. So we are not doing anything for that. Does this answer your question?

Andy Hsieh — William Blair — Analyst

Yeah. Any sort of publication strategies or presenting strategies for that trial? Or the focus is going to be on PROTECTIVE-2 going forward?

Lan Huang — Co-Founder, Chairman & Chief Executive Officer

Okay. So for the label, actually the pivotal trial is the PROTECTIVE-2, right? And then PROTECTIVE-1 is the supportive trial. And that’s what Ramon just mentioned, the PROTECTIVE-1, the Phase II portion has been accepted in the major journals for publication in the coming months. And of course, for this Phase III study we will also be planning for the publication as well. So you will see the data.

Andy Hsieh — William Blair — Analyst

I see. Excellent. All right, that’s helpful. Thank you.

Lan Huang — Co-Founder, Chairman & Chief Executive Officer

Okay. So Ramon can comment on the EAP, which is really very instrumental for Ramon to set this up, really just help cancer patients. Ramon.

Ramon Mohanlal — Executive Vice President, Research and Development and Chief Medical Officer

Yes. So the EAP program is up, we already have one investigator who approached us. And as you may be aware, we already have the first patient who was dosed with Plinabulin in the context of this EAP program. They have — we continue to see interest and we will assess as we go accommodate other investigators who have an interest in adding Plinabulin to G-CSF. The COVID19 environment, as you know, has impacted the healthcare dynamics, which tends to be different from state to state. So we continue to have interest in this program, we continue to build this program to the benefit of the patient and medical community.

Lan Huang — Co-Founder, Chairman & Chief Executive Officer

Okay, great. So, Rich, you want to answer the revenue question?

Richard J. Daly — Chief Operating Officer

Yeah. So I think this is a really interesting question. So thanks for posing it. Andy, I think it’s really timely. So we see this as an opportunity to, as Ramon alluded to, to help address the concerns. Our market research — we’re in the midst of doing market research right now. So all the market research I referenced on the — on my comments on the call were pre-COVID. And so, we’re doing market research right now to get a sense of how things might change in this environment. And actually the concern has ramped up considerably. We see in the first three months of the pandemic the number or the percentage of chemotherapy cycles has dropped by 20% to 40% depending on where you are in the country. And on average about 20% overall. Then that has recovered to a great deal, almost back to normal across the board, but that was really driven by the concern over exposing patients and putting them in an immunocompromised state.

So, our thought here was let’s get out there, and let’s be the good corporate citizen, and let’s help physicians and help patients who are concerned. So, it’s not our intention to use this as a revenue driver. We don’t see it as being that broad-based. And so it’s really more or less to just say, hey, here’s a helping hand, should you need it, and we think, there’s going to be some opportunity here.

We also understand that if we do this from a revenue perspective, we’re going to have to justify the cost based on — what we charge based on the cost of goods and I don’t think there’s any value in that for us in covering our costs, because, obviously, the exposure that’s there, so we really just have no interest in doing that. I think it’s not good for us in the long run. Hope, that’s helpful.

Andy Hsieh — William Blair — Analyst

Yeah, yeah. That’s super helpful. And yeah, that’s great from a visibility and potentially political standpoint. So, maybe last question for Rich. There appears to be a price war going on in the biosimilar G-CSF field, as new products come online, just curious about your thoughts on that implication to the commercial launch of Plinabulin?

Richard J. Daly — Chief Operating Officer

So this is one of the tailwinds that Lan alluded to in her commentary. When we talk to payers and it gets back to one of the questions I was asked earlier about the label, payers are excited about the opportunity to have multiple G-CSFs on the market, as you would expect, I mean, that’s not a surprise for anybody. And it’s really important for all of us to realize that payers do see us as — do see Plinabulin as unique and will treat it as such. They see the value that’s created, because it is the only product that can do what we said it can do, raise the standard of care, the only product in — on the market or in development. And so they say, well, we’re going to treat it as such. So we’re going to treat that way for formulary consideration and for contracting consideration, which is very favorable for us, first and foremost.

Secondly, it creates this opportunity. You see the first two biosimilars launched at a list price of a 33% discount. Third one launched at 37% discount. And we all know that these drugs are reimbursed on average selling price, or ASP. And we’ve seen the ASP drop considerably for the first two prices, not enough data for the third one yet, ASP is reported two quarters in arrears. So there’s not enough data yet to see exactly what’s happening, what the trend is with the third product, but the first two products, the lead product, its average selling price — the first product that was launched rather, its average selling price has dropped by 22%. And the second product, which is actually the market leader, its average selling price has dropped by 18%. That’s the latest data we have. So that’s more indicative of what’s actually happening in the contracting space. And as that average selling price drops, the reimbursement for physicians and oncologists make their living based on ASP plus 4.5%. This is hurting the physician.

So, you know, we’re looking at this opportunity as creating headspace for pricing. And when we talk about this with payers, payers are favorably inclined to that approach. We don’t bring it up, we say what you think is an appropriate place on the pricing continuum for it, and the payers come back and say, this looks like an appropriate place filling its headspace. So, we’re pretty excited about that, because as you get more and more of these, the biosimilars have two choices, they can try and tranche the market and you go for smaller and smaller slices, which doesn’t seem very appealing or they can play a price game, which to us were agnostic, we want to play with everybody. So this is all favorable for us. So, we’re pretty excited about it. And we see payers taking greater and greater control over the biosimilars, which will again cause them to contract on a much more rigorous basis, which again will drive prices down creating greater headspace. So, we’re excited about that. We think it’s good for us. Does that help?

Andy Hsieh — William Blair — Analyst

Yes, yes. That’s very helpful. Thank you.

Richard J. Daly — Chief Operating Officer

Sure. Thank you.


Thank you. We’ve reached the end of our question-and-answer session. I like to turn the floor back over to management for any further or closing comments.

Lan Huang — Co-Founder, Chairman & Chief Executive Officer

Thank you, operator. This concludes our call today and thank you everyone for your valuable time. Have a nice day.


[Operator Closing Remarks]


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