Morning. Welcome to BeyondSpring's Q2 2021 Financial Results Conference Call. At this time, all participants are in listen only mode. Following management's prepared remarks, we'll hold a brief question and answer session. As a reminder, this call is being recorded today, September 10th, 2021. I will now turn the call over to Monique Koyfman of LifeSci Advisors.
Thank you everyone for joining today's call. I would like to advise listeners that comments made on today's call may reflect forward-looking statements that are related to such matters as BeyondSpring's clinical and pre-clinical 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 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 Elizabeth Czerepak , Chief Financial Officer. It is now my pleasure to turn the call over to Dr. Lan Huang. Lan?
Hello everyone, thank you for joining today's call. We're very pleased to be here today reporting our Q2 results and providing an update on the many meaningful events in the recent weeks. Everyone here at company is very excited, as we have accomplished so much, but most importantly, we're most excited for patients who are our north star, who can be helped by our lead asset, plinabulin. Plinabulin is a first-in-class selective immunomodulating microtubule binding agent, or SIMBA. With clinical evidence from DUBLIN-3 and our CIN studies, we have revealed the dual benefit of plinabulin in the direct anti-cancer benefit of significantly extending overall survival, while also significantly reducing severe neutropenia induced by chemotherapy, which would be beneficial to patients in need.
From the execution point, we have much more to look forward to in the next 6- 12 months, including, first, our PDUFA date is on November 30th this year for plinabulin and docetaxel combination in CIN prevention, and upcoming commercial launch in Q1 next year. Second, a planned NDA filing for plinabulin in non-small cell lung cancer in the H1 of 2022. Third, continued development our rich and deep pipeline, including plinabulin in triple IO combo in various cancers. Each of our upcoming milestones has the potential to provide significant shareholder value. Let me begin today by recapping the very meaningful events and data from the recent few months.
I will then provide a few highlights of what to expect for us in the coming weeks and months before handing over to Ramon and Rich to provide more detail on our scientific and clinical accomplishments and commercialization plans. The past few weeks have truly been transformational for us at BeyondSpring. Most importantly, we were thrilled to announce positive data from our registrational trial of DUBLIN-3 in plinabulin in second and third line non-small cell lung cancer, which showed significant improvement in overall survival, especially in doubling the two-year and three-year survival in the plinabulin and docetaxel combination arm versus docetaxel alone. This underscores plinabulin's immune durable anti-cancer benefit and makes us optimistic for its potential in other cancer combinations like triple IO combos. We have always believed plinabulin to be a pipeline in the drug with the potential for approval in several indications.
With the direct anti-cancer data in non-small cell lung cancer, we're well on our way to realizing our vision for plinabulin. I will let Ramon provide more color on the study and some high-level data. We are presenting additional data in 10 days at a late-breaking oral presentation at ESMO on September 20th. We are planning to host the call after the ESMO presentation. Another meaningful recent announcement was our strategic partnership between Wanchunbulin, our 58%-owned China subsidiary, and Hengrui, a leading R&D and commercialization company with top expertise in oncology in China, for the commercialization and co-development of plinabulin in Greater China. This landmark partnership serves as a validation from a well-respected leading pharma for plinabulin as a pipeline drug.
Over the past 40 years, Hengrui has successfully grown to become the largest oncology drug sales company in China, with the top-selling PD-1 inhibitor and docetaxel product, and one of the top three G-CSF products. plinabulin's potential for use in combination with these agents represents significant synergies and facilitates the development of plinabulin in additional indications, thereby accelerating and increasing the achievement of peak sales in Greater China. Important to note, not only have we partnered with the most respected company with the widest and deepest reach in the oncology space in China, we have done so at favorable terms for us. We retain manufacturing rights and have the right to receive 100% sales proceeds while paying a reasonable percentage of the net sales to Hengrui and having all the commercialization costs covered by Hengrui. Additionally, we will receive significant upfront and 50% cost-sharing of development costs.
Of note, we will retain 100% of our plinabulin rights in all other global markets outside of China. The deal has attractive financial terms, which gives us more cash runway. This includes an upfront payment of around $30 million and milestones of up to around $170 million, plus a $15 million investment in Wanchunbulin at a pre-money valuation of around $560 million. As you are aware, our NDA for prevention of CIN has been accepted by China NMPA and the U.S. FDA with priority review, which will provide more details on our plans for commercialization and launch in the U.S. in early 2022, assuming approval by the FDA on our November 30th PDUFA date. Looking forward, I mentioned the most important date, PDUFA date of November 30th, 2021, for plinabulin in CIN prevention.
Additionally, our regulatory team are in high gear preparing for our NDA filing for non-small cell lung cancer indication, which we anticipate in the H1 of 2022. With plinabulin's unique immune mechanism as a SIMBA and its durable anti-cancer clinical evidence shown in the DUBLIN-3 study, we have a well-planned path of development for plinabulin in IO combos in various cancers to target unmet medical needs, which PD-1, PD-L1 could not help. First, in PD-1, PD-L1 failed patient. Second, the CIN issue in PD-1 and chemo combination. Third, immune-related SAE for IO combos. Fourth, the cold tumors. Fifth, first-line cancers which need better efficacy in IO combos. We have undergone a few investigator-initiated studies to help to assess plinabulin's role in addressing these unmet medical needs. Ramon will talk more about this in his presentation.
To summarize, I would like to thank our team for their commitment and tireless efforts. Everyone here believes in our mission, and their passion has been driving us forward towards raising the standard of care for cancer patients in the largest global markets of our first-in-class treatment. We're closer than ever now to achieving this mission, and we all look forward to advancing plinabulin and realizing upon our many opportunities to succeed. I will now turn the call over to Dr. Ramon Mohanlal for a brief review of our recent clinical developments. Ramon.
Thank you, Lan. As Lan indicated, we are eagerly awaiting the PDUFA date for the CIN application later this year. We were naturally awaiting the results from DUBLIN-3 to obtain confirmation of plinabulin's anti-cancer activity, which we have now. It was exciting to see that the plinabulin dose-escalation combination in DUBLIN-3 had met both the primary endpoint for overall survival and the key secondary endpoint for ORR and PFS. The significant reduction in Grade 4 neutropenia by fivefold with the combination versus docetaxel alone supports plinabulin's CIN prevention benefit. The four-year OS rate at 10.6% for the combination with plinabulin versus 0% with docetaxel alone underscores the durable anti-cancer benefit for plinabulin and is consistent with its immune mechanism of action. I also would like to mention that we conducted DUBLIN-3 at high-quality centers on the U.S. GCP. We used quality CROs for the conduct of DUBLIN-3.
ICON was our global CRO for site selection, patient enrollment, and monitoring. All blood samples were sent to Covance Central Laboratory for pharmacokinetic and hematology assessments, including neutrophil count. ICON Pharmacovigilance was used for safety processing. As Lan mentioned, plinabulin's next focus in our clinical development program is to develop IO combinations in multiple cancer indications. Earlier this year, we presented phase I clinical data with plinabulin in combination with nivolumab and ipilimumab in small cell lung cancer, demonstrating a doubling of the anti-cancer results normally seen with nivolumab and ipilimumab alone. In that study, we also demonstrated that plinabulin could reverse resistance to prior checkpoint inhibition therapy. Specifically, in this small cell lung cancer phase I data, which was presented at ASCO earlier this year, patients from U.S.
sites had an ORR of 46% in second and third line, and an ORR of 43% for PD-L1 inhibitor-failed patients, which also had a long duration of response, as long as 18 months. At MD Anderson, we are conducting an Investigator-Initiated Trial in seven different cancers evaluating the safety and tolerability of plinabulin in triple IO combination therapy with both PD-1, PD-L1 antibodies and radiotherapy in PD-1, PD-L1 failed patients. The first patient was enrolled in this Phase I-B/II trial in June of this year. As was mentioned before, resistance to immunotherapy is a severe unmet medical need, and we believe plinabulin may have a potential synergistic anti-cancer effect when combined with checkpoint inhibitors and radiotherapy.
Based on plinabulin's unique mechanism of action and early clinical data, we believe that adding plinabulin to checkpoint inhibitor therapy with or without chemotherapy has the potential to improve anti-cancer efficacy while reducing toxicity with IO and/or chemotherapy. We believe that these early trials are providing collective evidence of plinabulin's role in addressing the unmet medical need in immuno-oncology therapy. On the organizational side, we are rapidly building our medical affairs capabilities in support of the upcoming commercial launch efforts. With that, I will now turn the call over to Rich, who will discuss our commercial preparations. Rich?
Thank you, Ramon. Our pre-launch activities and preparations for a commercial launch in the CIN market are building, with our PDUFA date set for November 30th. Over the next several months, our seasoned commercial leadership team is preparing to deliver a fully integrated market preparation and launch program to support a successful launch of plinabulin in early 2022, complete with elements such as driving awareness of the unmet medical need, or what we call the Neutropenia Vulnerability Gap, continuing our large account outreach, preparing for NCCN guidelines submission, KOL development, speaker mobilization, key stakeholder outreach, including patient groups and federal, state, and local legislative initiatives, educational symposium, targeted advisory boards, and finalizing our patient support services to ensure broad access at launch. Specifically, we plan for a dedicated and focused team for the U.S. market.
Importantly, we will have a field reimbursement liaison team supported by a patient services hub in place to ensure effective reimbursement from day one to provide support for both providers and patients. We believe this extensive commercial strategy will position us well to successfully launch plinabulin combination therapy to capture long-term commercial success. We look forward to updating you on our progress with our pre-launch activities in the coming months. Now I'll turn over to Elizabeth to take you through the financial results. Elizabeth?
Thanks, Rich. I will now briefly discuss our Q2 2021 financial results. For greater detail 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, I will now highlight some of the key financial results. R&D expenses in the Q2 of 2021 were $11.3 million, compared to $11.0 million in the same quarter last year. The increase of $0.3 million was primarily due to an increase in personnel cost and non-cash stock-based compensation expense, partially offset by lower clinical trial expense. G&A expenses were $9.0 million in the Q2 of 2021, compared to $2.6 million for the same quarter of 2020.
The $6.4 million increase was primarily due to higher personnel cost, non-cash stock-based compensation expense, and higher costs associated with pre-commercialization activities for plinabulin. Net loss in the Q2 of 2021 was $19.3 million, compared to $12.8 million for the same period last year. Our cash balance at the end of Q2 was $51.3 million, and we had short-term investments of $25.0 million, which we believe will be sufficient to support our ongoing clinical programs over the next year, including our immune oncology pipeline, and to prepare for the potential launch of plinabulin in CIN in early 2022. In addition to reported available cash, we will also receive from Hengrui approximately $45 million for a $30 million upfront payment, plus an equity investment into the China subsidiary related to the plinabulin partnership in China, which Lan described.
I do also want to mention that in the U.S., Rich has updated on our efforts to prepare for our own launch of plinabulin in CIN, and we are also evaluating potential partnership opportunities in the U.S., Europe, and other parts of Asia outside of Greater China. We are only considering the very top companies who could bring great synergies and help us optimize the value of plinabulin globally. With that, I will now turn the call back over to Lan for closing remarks. Lan?
Thank you, Elizabeth. We're very proud of our accomplishments thus far. We have had extremely busy and productive period recently, but we're just starting. Everyone feels the momentum building, and our excitement grows as our vision of commercializing plinabulin and expanding on our indications comes closer, with the potential to help many patients in need. We invite everyone to watch for us at ESMO on September 20th, where we will make a late-breaking presentation on our DUBLIN-3 phase III data in non-small cell lung cancer, and our partners for their continued support as we work towards improving the current standard care for cancer patients worldwide. This concludes our prepared remarks today. I will now ask the operator to begin our Q&A session. Operator?
Thank you. At this time, we'll be conducting a question and answer session. If you'd like to ask a question today, please press star one from your telephone keypad, and a confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants that are using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please while we poll for questions. Once again, that is star one to ask a question. Thank you. Our first question is coming from the line of Josh Schimmer with Evercore ISI. Please proceed with your question.
Great. Thanks for taking the questions. First, what type of information should we be looking for from the DUBLIN-3 trial at ESMO, and specifically, are we going to be getting the subset analysis which investors have been very focused on? Second, investors are clearly concerned that the DUBLIN-3 trial may not suffice for FDA approval, given that the trial was run mostly outside the U.S. and in PD-1 naive patients. As you're discussing the program with partners, do you expect that you're going to need to wait for full approval by the FDA to capture the full value of the program in some kind of a partnership deal? Thank you.
Well, thank you so much, Josh, for your continued support, and thanks for this great question. Let me just touch on both questions. Number one is for the ESMO presentation. We are going to show the whole data, the ITT population, with all the specific numbers with it. And in addition, we're also going to show the subset analysis everyone is so eagerly waiting to see, including the PD-1/PD-L1 exposed patients and also the Western patient subset. That's the number one question. Number two is regarding your question on the relevance of the study with limited patients from the U.S., how it relates to the U.S. population, right? We think that currently our patient population does capture the current landscape of treatment to the biggest extent because we do have patients who have been exposed to PD-1/PD-L1.
From the previous experience in FDA approvals for oncology drugs, there were incidents of approval using limited patient data from the U.S. According to the IQVIA report, 27% of the U.S. FDA oncology drug approval actually used less than 10% data from the U.S. Of course, this is a review issue, so we will be eagerly discussing this with FDA in our planned pre-NDA meeting. We're planning for Q4 of this year. Regarding the partnership discussion, I think this of course, is a very important topic to discuss, but we cannot give any details at this moment.
Okay, super. Thanks very much. Looking forward to the ESMO presentation.
Yeah, thank you.
The next question is from the line of Jason Gerberry with Bank of America. Please proceed with your question.
Hey, guys. Thanks for taking my questions. Two for me on DUBLIN-3. Probably not a big surprise, just can you, Lan, maybe walk us through the history of the trial, the interim analyses, and whether median OS or Kaplan-Meier OS were the pre-specified primary endpoint, and whether there were any protocol changes that occurred during the trial? My second question is just, there isn't much debate that Kaplan-Meier OS is a gold standard for measuring OS, but I think investors believe that supportive median OS is needed to ensure that the clinical benefit is meaningful. Just love to get your thoughts on the regulatory implications of supportive median OS, particularly if it falls in a more gray area or even a negative P value. Thanks.
Well said. Thank you so much, Jason, for your great questions regarding the more details in the history of DUBLIN-3 and also the primary endpoint questions. First is, DUBLIN-3 has been ongoing for almost six years, it has been a long trial because it is 551 patient enrollment globally in U.S., China, and Australia. Along the way, the treatment landscape has also changed, right? There are PD-1, PD-L1 treatments approved during the study. During the study, we did update the protocol to include the allow lines to have PD-1, PD-L1 failed patients in the study and stratified them. That's why we are confident with the balancing of two arms with PD-1, PD-L1 exposed patients. Secondly, regarding the primary endpoint. The primary endpoint has always been overall survival. It has never been changed.
It's just the analysis of the data methods, right? One is using the log-rank P value, looking at the whole Kaplan-Meier OS curve, including in there will be median OS shown. In addition, we're also putting the restricted mean survival time, which is looking at the mean OS, because plinabulin is an immune agent. The mean potentially captures more of the OS benefit for plinabulin arm, but both are going to be shown in the ESMO and also with the NDA filing. Everything is transparent, and everybody can see what is the profile for plinabulin. In the end, the drug is the profile from the KM OS graph, and that's the key. Along the way, we did have the two interim analysis.
There is a little historical P value hit, statistical hit for the final P value, which we need to meet for the log-rank P value, which is 0.046. What we have said in top line is log-rank P value for the DUBLIN-3 in the plinabulin versus plus docetaxel versus docetaxel is less than 0.04. That does meet this statistical significance in extending overall survival in the primary endpoint. Of course, everybody will see more details in the ESMO. Thank you.
Thank you. Our next question is from the line of Maury Raycroft with Jefferies. Please proceed with your question.
Hi, good morning. Thanks for taking my questions. To tie this subset analysis together for PK bridging data between Western and China patients, is it possible you could disclose some of the PK bridging data at ESMO or at some other point prior to filing the NDA?
Yeah, thanks for this great question, because this is very important for us to be able to combine the Western and Asian patient data for the NDA submission, not only for the U.S., but also for China FDA. We have done extensive population PK and everybody in our CIN studies and also in lung cancer study, everybody has a population PK. We have rich data for almost over several hundred patients on those data. Currently, we have submitted those data to the regulatory agency, and the PK comparison data usually is not in the presentation or for the registration study or in the publications. Of course, if everyone's very interested, probably in the future, we should have some kind of a public review on this later. It's not going to be discussed in the ESMO, but it is consistent. We're very confident with.
Got it. You're confident in the consistency that you're seeing between the patient populations?
Yes. They are comparable. They're similar in the population PK in Asian versus Western patients.
Got it.
We have shown that in many studies. All the PK data came from Covance, right? We use Covance as our central lab.
Okay. One other question just for the CIN NDA that's under priority review, can you talk more about the regulatory interactions and feedback, and whether you've had a mid-cycle review communications and any label discussions yet?
Yeah. Thanks for this great question. Everyone's eagerly waiting for the final date, which is November 30th. Yes, FDA has been communicating with us in frequent manner and is very supportive of our submission because we did have AOM meeting before the document had been successfully received by FDA. We also had mid-cycle review, and we haven't got to the label discussion yet because it usually is one to two months before the PDUFA date, then there will be label discussion.
Got it. Okay. Thank you very much for taking my questions.
Thank you.
Next question is coming from the line of Andy Hsieh with William Blair. Please proceed with your questions.
Great. Thanks for taking my questions and, again, congratulations to the team on a, as you said, transformative H1 and a great start to 2021. I have two questions really, kind of related to Jason's questions before. One is really, Lan, maybe you can comment on just how DUBLIN-3 is conducted from a quality control standpoint, data integrity standpoint. I think there's a lot of questions regarding that. Also since, Lon, you talked a little bit about the P values, I wanted to kind of get your clarification in terms of the P values listed in the presentation back several weeks ago following the DUBLIN-3 top-line results. I noticed that there were a lot of the P values that basically provided a range and not basically a single number.
I just want to clarify that is due to the fact that analysis was still ongoing and that was kind of the top-line results and we'll basically get detailed exact P values at the ESMO conference.
Yes. Thank you so much, Andy, for your great questions and also always your great support. Let me answer your three questions in sequence. Number one is, we are very confident with our quality of the data because we are using the quality CROs to conduct the study, as what Ramon just related to you. Our global CRO is ICON, which in charge of site selection and patient enrollment and also the monitoring. Secondly, we're also using Covance Central Labs to look at all of our blood samples to evaluate the PK and also the blood chemistry, including the ANC numbers. Because you know the ANC actually is important for our secondary endpoint, looking into the grade for neutropenia reduction in plinabulin arm versus the docetaxel arm.
Thirdly, we also use ICON PV to actually do the SAE reporting and also collect all the AE data for all the studies, including DUBLIN-3 and also CIN studies and all the ITT studies. The last but not least, I also want to mention we also use ERT, which is a central lab company and they actually send all the ECG machine to all the sites to take triplets for the ECG to look at the cardio safety for the drug. All of this is well validated CROs. Also, our conduct is under U.S. GCP. So that answers your first question. Number two is the data integrity. Actually, we do use independent statistical company to do the analysis of the data. Also, it's also a single-blinded study to the patients.
Patients, when you look at the quality of life data, it will be very trustworthy because patients do not know which arms they are on. That's the second question. The third question is a great question, a clarification for the P value in all the sum of the primary and also the secondary endpoint, which we actually had released in the top line, because this is a top line, right? Really, we cannot disclose much because we are saving it for a big major medical conference, which is coming up in ESMO. That's why it was just only showing a range.
Okay, great. Thanks for all the detailed explanations, Lan. Maybe just one more. Kind of heading into the ESMO conference, I wanted to get your perspective on how you would view the PFS data. Obviously, whenever you look at OS, it's always kind of confounded by subsequent therapy. Maybe kind of a two-parter. One is, maybe can you comment on, based on the geography, what are some of the subsequent therapies that patients could get on DUBLIN-3? Also, how would you kind of interpret and look at the PFS results, in the context of the positive OS?
Yeah, that's really a brilliant question. For all the clinical studies, I think the gold standard is OS, right? In the end, we want to provide the lifetime survivor for patients. That is what all the patients and the FDA and also physicians are looking for. OS is the gold standard. In addition, we also want to use PFS and ORR also to look at the drug effect, right? There's no noise from the later treatment. That is what you are getting at. Do we see a drug effect adding to the benefit of docetaxel in the PFS? As you see, the P value is less than 0.01 from the directional P value, which we shared in the top line.
We are seeing better improvement in plinabulin adding to docetaxel, not only in the PFS benefit and also in the ORR, which will also show statistical significance. Your last question also asked about what's the later treatment after the patients out of the study. As you know, both it is a randomized study, so both arms are balanced. Patient after they get out, of course, they do have a desire to live, so have a good therapy to be treated. Afterwards, they usually use TKIs, and also they do have PD-1 or PD-L1 exposures, but limited. Also, they are balanced.
Got it. Okay.
Thank you.
That's helpful. Thank you very much.
Yeah. Thank you.
The next question is coming from the line of Joel Beatty with Baird. Please proceed with your question.
Hi. Congrats on the progress. For the CIN indication, there's been recent attention among investors that most of the patients in the trials were from outside the U.S. Could you discuss if FDA is okay with the number of U.S. patients in the CIN studies? Could you discuss how closely the chemotherapy regimens used in those CIN studies resemble what's currently used in the U.S.?
Well, thank you so much, Joel, and thanks for initiating the report for us recently. This is a great question. For the CIN indication, as you know, we're going after a broad label for plinabulin, combined with G-CSF, in preventing of CIN in all chemotherapy and all solid tumor. It is a broad label, and Study 106, phase III or PROTECTIVE-2 is a pivotal study which supports this label. In addition, we also have five other clinical studies to support this label from a safety point of view and also from plinabulin's pharmacology in its working in protecting neutrophil in week one after chemotherapy as what 96%-100%, according to literature, right? There's a lot of room to improve there. In a way, it's not so relevant to show, is TAC still used in the U.S.?
It's more like it's used as a template to evaluate the drug effect for plinabulin, combination with G-CSF or any new agent in development for the CIN prevention. Coming back to the 1,063 patient population, it's from two countries, right? Around 50% in China, 50% around in Ukraine. Ukraine patients are representing the Western patients, and FDA agrees with that. China, of course, is Asian patients, because U.S. just rarely use TAC, because TAC with G-CSF still have such harsh grade 4 neutropenia as high as 100%. It's not really used very much, a lot of toxicities are used for breast cancer. For the Eastern Europe and China, still TAC is used. That's why you can enroll patients to really evaluate plinabulin's drug effect. So far, FDA hasn't had any issues with this breakdown because they have seen our raw data.
They also look at our clinical conduct, also look at the eTMF and everything. This has not been an issue, they have successfully accepted our filing with priority review also with no ODAC.
Got it. Thanks for all those helpful details. One more question related to discussions with potential partners for the U.S. and other countries. How much of the focus on those potential partners is on marketing versus clinical development of additional indications?
Well, I think this probably, it's still ongoing with the potential partners, I think for the U.S. global market potential partnership. This is, of course, it's a combination of all of that, right? Because it is very important, plinabulin is shown as potentially now has this dual benefit in the anti-cancer benefit, in extending survival, and also in reduction of Chemotherapy-Induced Neutropenia. With that profile, it really is a gateway into multiple indications. We believe in the IO combination therapy. Of course, partners will be very interested in those additional development, which will give a lot of potential for plinabulin, and in the end, is to help many patients. Of course, commercialization is near term, right? That's also in the discussion points.
As you see from our recent partnership deal with Hengrui, which is a very respected company in China in the oncology space, we do think the synergy is also giving us a 1 plus 1 greater 2. In their discussion, as you see from the terms, right? Commercialization, we are very much grateful to their support because they have top sellers of PD-1 and also top sellers of docetaxel, and top three seller of paclitaxel, but also they have a lot of other agents in their pipeline actually, which could potentially also in combination with plinabulin, because plinabulin is a very interesting and multi-talented child in a way. Those are going to have more indications and more differentiated therapy regime, potentially, for patients in need.
Thank you.
Thank you for the great questions.
As a reminder, if you'd like to ask a question, you may press star one. The next question is from the line of Joe Pantginis with H.C. Wainwright & Co. Please proceed with your questions.
Hey, everyone. Good morning. Thank you for all the details. I think you've done a good job, really, in addressing a lot of potential concerns that are out there, so thanks for that. I actually have a couple logistical questions. First, with regard to Hengrui, just wanted to see what are some of the rate-limiting steps right now? You have some tech transfer to do. What other things are outstanding to make sure that they could efficiently launch plinabulin efficiently?
Yeah, that's a great question. That's what we're currently actively doing with Hengrui. Our China team is working with them starting from the second day from the signing. From August 26th, we have been working daily with our partner at Hengrui. They're very eager to get all of their medical science liaison team on board, in understanding and also making the messaging right.
Just regarding the milestone payments, how are you looking to account for these, and amortize or recognize upfront or what have you?
Yeah. Thank you for that question, Joe. We are very actively discussing that with EY, who's our global auditor. We for sure will be booking all of the monies that come in. We've not given up booking of revenue. Yes, we'll have to go through the dance with them on deciding how to book the revenue.
Understood, and thanks for all the details.
And-
I'm looking forward to ESMO. Sorry. Yeah, go ahead.
Yeah. I was going to say, and as far as the milestones go, of course, those will receive, I'm sure, very normal accounting treatments, and hopefully, some will be problems of booking that we'll have to deal with sooner rather than later. We expect that.
Sure. Thanks again.
Thank you. There are no further questions. I will now turn the call over to Dr. Huang for her closing remarks.
Thank you, operator. Thank you again, everyone, for joining us for the call today. Your time is precious. Thank you for being on this meaningful journey with us to support us. Together, you are our partners to help many patients in need. Thank you and have a nice day and have a nice weekend.
This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.