Q2 2021 BeyondSpring Inc Earnings Call
Good morning, welcome to be on spring second quarter 2021 financial results Conference call.
At this time, all participants are in listen only mode.
Following managements prepared remarks, well 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 Mani coffee of lifestyle 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 beyond springs, clinical and preclinical research and development activities and results regulatory and commercial plans industry trends market potential collaborative initiatives and financial project.
<unk> 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 that.
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 beyond Springs website.
Joining us on today's call is Doctor Flaunt long beyond spring co founder Chairman and Chief Executive Officer, Dr. Ramon Mahalo Executive Vice President Research and development and Chief Medical Officer, Richard Daly, Chief operating Officer, and Elizabeth surpass Chi.
<unk> financial officer.
It is now my pleasure to turn the call over to Dr. Lon long long.
Hello, everyone and thank you for joining today's call.
We're very pleased to be here today reporting our second quarter results.
And providing an update on the many meaningful event in the recent weeks.
Everyone here at the company is very excited as we have accomplished so much but most importantly, we're most excited for patient, who Oh and Northstar, who can be helped by our lead asset <unk>.
And that is a first in class selective immuno modulating microtubule binding agent or seen.
With clinical evidence from Dublin Street, and Oh, Yeah, and studies, we have revealed that dual benefit they'll cannabinoid in the direct anti cancer benefit of significantly extending or survivor, while also significantly reducing the V. A.
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 six to 12 months.
Including first.
But you have a date.
On November 30th this year, well Canavalin and you say, it's a combination.
See I am prevention and upcoming commercial launch in first quarter next year.
Second our planned NDA filing for <unk> in non small cell lung cancer in the first half of 'twenty 'twenty two.
And third.
Continued development, our rich and deep pipeline, including Pineapple and Triple I O 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 a mall and rich to provide more detail all of scientific and clinical accomplishments and commercialization plans.
Again, the past few weeks have truly being transformational for us at beyond spring.
Most importantly, we were thrilled to announce positive data from our Registrational trial of doubling straight in Panera blend in second and third line non small cell lung cancer, which showed significant improvement in gold bar survivor, especially in doubling the.
Two year and three year survivor in the pillar <unk> and Docetaxel combination arm versus Docetaxel alone.
This underscores Netherlands immune durable anticancer benefit and makes us optimistic for its potential in other cancer combination like Triple I O combos.
We have always believed phenomenon to be a pipeline in a drug with the potential for approval in several indications.
With a direct anti cancer data in non small cell lung cancer, well, well I'll wait to realizing our vision for kannapolis.
Our luck Ramon provide more color on the study and some high level data.
We are presenting additional data in 10 days at the late breaking oral presentation at ESMO in September 20th we're planning to hold the call. After the ethanol presented a chef.
Another meaningful recent announcement, what's our strategy partnership.
<unk> been troubling, our 58% owned China subsidiary and highway a leading R&D and commercial like they shouldn't company with top expertise in oncology in China for the commercialization and co development at Panera.
In greater China.
This landmark partnership serves as a validation for from a well respected leading pharma bullpen islands as a pipeline in the drug.
Over the past 40 years, Hi, Ray has successfully grown to become the largest oncology drug sales company in China was the top selling PD, one inhibitor and Docetaxel product and one of the top Street G CSF products.
And that has potential for use in combination with this agent represents significant synergies and facilitates the development of Panera blanking additional indications, thereby accelerating and increasing the achievement of peak sales in greater China.
Important to note.
Not only have we partner with the most respected company with the widest and deepest rich in the oncology space in China.
We have done so at favorable terms for us.
Weird tank manufacturing rights and they have the right to receive 100% sales proceeds.
Paying a reasonable percentage of.
If the net cells to her right and having all the commercialization costs covered by highway.
Additionally, we will receive significant off round and 50% cost sharing of development cost.
Of note, we will retain 100% of our cannabinoid rights in all other global markets outside of China.
Finally, the deal has attractive financial terms, which gave us a small cash runway. This includes an upfront payment of around 30 million and the milestones of up to around 870 million plus the $15 million investment.
England trembling at a pre money valuation of around $560 million.
As you all were O M D H for preventing shelves, yeah and had been accepted by China and M. P E and the U S FDA, which proud sugar view.
Rich will provide more details on our plans for commercialization and launch in the U S. In early 'twenty kind of chew assuming approval by the FDA on November 30th put two five date.
Looking forward I mentioned, the most important date, but do first date of November 30th 2021 will pan out, but let me see I am prevention. Additionally.
Additionally, our regulatory team I am heikki are preparing for our NDA filing for non small cell lung cancer indication, which we anticipate in the first half of 'twenty two.
Finally.
With Canavalin unique immune mechanism is the same box and it's doable anti cancer clinical evidence shown in the Dublin Street study will have a well planned paths of development for Panera, Blaine I O combos, embarrassed, Kansas to target unmet medical needs, which T D.
One P D O I could not help.
First in PD, one PD L. One failed patient SEC.
The yeah and issue in P. Do you want and chemo combination Serge.
Immune related SAE for I O combos force, the cold tumors, and Sips first line, Kansas, which needs better efficacy I O combos.
We have undergone a few investigator initiated studies to help to assess.
<unk> role in addressing unmet medical needs Ramon will talk more about this in his presentation.
So to summarize.
We'd 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'll all look forward to advancing canavalin and realizing upon our many opportunities to succeed.
I would now turn the call over to Dr. Ramon Mahalo for a brief review of our recent clinical developments.
Ramon.
Thank you Lana.
Islam indication.
We are eagerly awaiting the paducah date for the Cin application later this year.
Okay.
Be there nationally amazing the salt from Dublin three two.
To obtain confirmation.
Oftentimes anti cancer T C.
Which we have now.
It's also exciting to see that diplomat and do so combination involved in three.
Hadn't met both.
The primary endpoint for overall survival and the.
The key secondary endpoint for O R. R N PFS.
The significant reduction in grade four neutropenia by fivefold.
The combination cirrhosis docetaxel alone.
Support for Avon and Cin prevention benefit.
Before your OSB.
At 10, 6% for the combination that from happening.
Zero Okay.
With those hotels alone.
On the scores the durable anticancer benefit for from happening.
And it's consistent with its immune mechanism of action.
I also would like to mention that he conducted golden tree.
It's high quality centers.
The U S D C T.
We use quality Seattle for the conduct of Goldentree.
IPhone.
Our global Seattle for site selection patient enrolled and monitoring.
All blocks off the fence to Covance Central laboratory.
Poor pharmacokinetics, and hematology assessments, including neutrophil counts.
IPhone pharmacovigilance.
Ah well shoes for safety processing.
As Tom mentioned for Nash.
Our next focus in all clinical development program.
We used to develop Io combination in multiple cancer indications.
Earlier this year, we presented phase one clinical data have been phenomenal.
In combination with known him up and if you live in that.
Small cell lung cancer.
Demonstrating a doubling of the anticancer the salt normally seen with all of that and if you live in methanol.
Is that sort of D V also demonstrated.
That's another good reverse resistance to <unk>.
Prior checkpoint inhibition therapy.
Specifically in the small cell lung cancer phase, one data, which were off the census at ESMO earlier this year.
Patients from Europe sites.
Had an O R or a 46% in <unk>.
Second actually that line.
And.
Or or or 43%.
For PD L. One inhibitor for patients with.
<unk> also had a long duration of response.
As long as 18 months.
And.
Awesome.
We are conducting an investigator initiated trial.
In seven different Kansas evaluating the safety and Tolerability of Netherlands.
People I O combination therapy with both PD, one PDL, one antibodies and radiotherapy.
And PD, one PD L. One field patients.
The first patient enrolled in this phase won't be two trial in June of this year.
That's what I mentioned before.
Resistance to immunotherapy is fear on that medical need and it.
Beliefs, 11 may have a potential synergistic anticancer effect right.
When combined with checkpoint inhibitors and radiotherapy.
Based off of that and its unique mechanism of action and early clinical data.
We believe that adding to that and to checkpoint inhibitor therapy with or without chemotherapy.
Has the potential to improve anticancer efficacy, while reducing toxicity with io and or chemotherapy.
We believe that these early trials are providing collective evidence.
<unk> role in addressing the unmet medical need in immuno oncology therapy.
On the organizational side, we are rapidly building, our medical affairs capabilities.
It's the core of the upcoming commercial launch effort.
With that I will now turn the call over to rich who will discuss our commercial preparations.
Rich.
Thank you Ramon.
Our prelaunch activities and preparations for commercial launch in the Cin market are building with our Paducah date set for November 30th.
For 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 for that one in early 2022.
Complete with elements, such as driving awareness of the unmet medical need or we call. It the neutropenia vulnerability GAAP.
Our large account outreach.
Caring for N P C N guidelines submission.
Paywall 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 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 that happened in combination therapy to capture long term commercial success.
We look forward to updating you on our progress with our prelaunch activities in the coming months.
And now I will turn it over to Elizabeth to take you through the financial results.
Elizabeth.
Thanks Rich.
I will now briefly discuss our second quarter 2021 financial results were.
For greater detail related to these results I refer you to our press release issued this morning and to our 6K 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 second quarter of 2021 were $11.3 million compared to 11.0 million in the same quarter last year.
The increase of <unk> 3 million was primarily due to an increase in personnel costs and noncash stock based compensation expense, partially offset by lower clinical trial expense.
G&A expenses were 9.0 million in the second quarter of 2021.
Compared to $8.0 million for the same quarter of 2020.
The $10.0 million dollar increase was primarily due to higher personnel cost noncash stock based compensation expense.
And higher costs associated with pre commercialization activities for Poland and Ireland.
Net loss in the second quarter of 2021 was $22.0 million compared to $20.0 million for the same periods last year.
Our cash balance at the end of second quarter 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 Plum, Avalon and Cin and early 'twenty 'twenty two.
In addition to reported available cash we will also receive from Andre approximately $45 million for a $30 million upfront payment plus an equity investment into the China subsidiary related to the Plum Ambulant partnership in China.
Which one 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 pulling abiel and in Cin and we're 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 upon that'd be one globally.
With that I will now turn the call back over to Lon for closing remarks.
Lon.
Thank you Elizabeth.
We're very proud of our accomplishments thus far we.
We have had extremely busy and productive period recently.
I was just starting.
Everyone feels the momentum building and our excitement grows as our vision of commercialization canavalin and expanding our indications comes closer with the potential to help many patients in need.
Well you might everyone to watch for us at ESMO September 20th well, we will make a late breaking presentation at Dublin, three phase III data in non small cell lung cancer.
And our partners for their continued support as we work towards improving the current standard of care for cancer patients worldwide.
This concludes our prepared remarks today.
I would now ask the operator to begin our Q&A session.
Operator.
Thank you.
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 he would like to remove your question from the queue.
So physicians 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 and once again that is star one to ask a question.
Thank you. Our first question is coming from the line of Josh Schwimmer with Evercore ISI. Please proceed with your question.
Great. Thanks for taking the questions first what type of information should we be booking for from the Dublin three trial at ESMO and specifically how are we going to be getting the subset analysis, which should investors have been very focused on it and then second investors are clearly concerned that the Dublin three trial may not suffice for FDA approval.
Given that the trial was run mostly outside the U S. And then PD one naive patients as you're discussing the program with partners do you expect that youre 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 well your continuous support and things like this so great question. So let me just touch on both those questions number one is what it has more presentation.
We are going to show the whole day that the ITT population whats called the specific numbers what is that.
In addition, we're also going to show a subset analysis have you why he's so eagerly waiting to see including the PD, one PD L and expose patients and also the western patient subset.
So that's number one question number two is regarding your question on the.
Relevance of the study was limited patience from you is how it relate to the U S population right. So when you think that you know currently our patient population does capture.
You know the current landscape for treatment to the biggest spend because we do have.
Patients, who has exposed to PD, one PDL, one and up from the previous experiencing FDA approvals for oncology drugs that were incidents of approval using limited patient data from the U S.
According to that you'll be able to report 27% of the U S. FDA I'm kind of struck a pool that you use less than 10% either from the U S. So of course. This is a review issue. So we will be equally discussing this with FDA in our plan.
The pre NDA meeting.
We're planning for quarter four of this year regarding the partnership discussion I think you know this of course is a very important topic to discuss but we cannot give any details.
But.
Yeah.
Okay Super Thanks, very much looking forward to the ESMO presentation.
Yeah. Thank you.
Yeah.
The next question is from the line of Jason <unk> with Bank of America. Please proceed with your question.
Hey, guys. Thanks for taking my questions.
Two for me on and Dublin are probably not a big surprise, but just could you.
Maybe walk us through the history of the trial the interim analyses in and whether median OS or Kaplan Meier O S, where the pre specified primary endpoint.
And whether there were any protocol changes that occurred during the trial and then my second question is just there isn't much debate the Kaplan Meier OS is the gold standard for measuring our west, but I think investors believe that you support of median OS as needed to ensure that the clinical benefit is meaningful so just love to get your thoughts on the regulatory.
<unk> of supportive median OS, particularly if it falls in the in a more gray area or even a negative P value. Thanks.
Yeah, well. Thank you so much Jason for your great questions regarding the more details in the history also had that been three and also the primary endpoint questions. So first is the issue has been ongoing for almost six years. So it has been a long trial because it is oh.
550 on patient enrollment globally U S, China, and Australia, So along the way, though treatment landscape has also changed right and you know there are PD one PD L. One cheap that's approved during this study. So we did you know doing the study would you update the protocol to include.
Hum that allow launch to have no PD, one PDL one cell patients in the study and Scott if I jump. So that's why we are confident with the balancing of two arms was that PD, one PD one PDL one exposed patients in a second.
Lee regarding the primary end point, so the primary endpoint has always being overall sub forever.
I've never been changed it's just the analysis of the data you know my sense right. So why is using a log rank P value looking at Oh, yeah, the whole pepto, Alaska, including in there. It would be you know medium Oh at Shaw.
In addition, we're also putting the restrict you mean survival time, which is looking at me I'll ask because that is a new agent the mi potentially captures more of the Oh watch benefits well benevolent arms, but those are going to be shown in the ESMO and also with the NDA.
So everything is transparent.
You can see our you know what is the.
Profile will kind of happen. So in the end. It's a drug is the profile from the G boss glass and that's the key so along the way we did have two interim analysis right.
So and so there is a little history.
Hum P value hit statistical hedge for the final P value, which wouldn't you meet with a log rank P value, which is clinical four six and what we have set in popular is a walk rank P value floor, but that being straight in the novel numbers plus docetaxel.
So is that some point all sorts with that it does meet this statistic, Wisconsin in extending overall survivor in the in the primary endpoint. So of course, everybody wants to see what do you tell us in the in the ethanol.
Thank you.
Thank you.
Our next question is from the line of Maury Raycroft with Jefferies. Please proceed with your questions.
Hi, good morning, and thanks for taking my questions.
To tie the subset analysis together for a PK bridging data between western and Chinese 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.
Quick question because this is very important for us to be able to combine our western and H M patient data for the NDA submission not only for <unk>, but also for China FDA. So we have done extensive population PK.
The body English, Yeah, and studies and also in lung cancer study everybody has a population PK. So we'll have rich data for almost.
Oh, the like several hundred patients.
Although stay that still kind of June we have.
Submitted those data to the regulatory agency and that this is not the PK comparisons there that usually is not in the you know presentation, Oh, you'll sort of registration study are in the probably patients of course everyone's very interested in the future.
Sure you'll have some kind of.
Public.
I'll review. This later, but this is not it's not going to be discussing.
Discussing the asthma, but it is conscious.
We're very confident with.
Got it so you're you're confident in that consistency that you're seeing between the patient population, yes, yes, yeah, yeah, a comparable or similar in that population PK in Asia versus western patients.
Got it who have shown that in many studies and all of the PK data that came from coal guidance right, we use called that Joe or South Central lab.
Okay and then 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 got a mid cycle review communications and any label discussions yet.
Oh, yes, absolutely. It's a great question, otherwise you're going to be waiting for the final.
Uh huh.
Final dates which is November 30th yes, So I urge FDA has been you know communicated with us.
In food can matter and they were supportive of our submission because we did have a meeting before the document has been successfully received by FDA. We also had a mid cycle review them and we haven't got to that label discussion yet because it usually is.
Wanted to moms before does that does that take and it'll 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 say with William Blair. Please proceed with your questions.
Oh, great. Thanks for taking my questions and again congratulations to team on it.
As you said churn for transformative for.
First half.
We start 2021.
So two questions really related.
Related to Jason's questions before one is really.
One maybe you can comment on just how Dublin is conducted from a quality control standpoint.
Data integrity standpoint.
I think theres a lot of the questions.
Questions regarding that.
And also since you talked a little bit about the P values.
On it too.
Kind of get your clarification in terms of the P values.
Listed in the presentation.
Back several weeks ago.
Following the Dublin three topline results.
It is that there were a lot of the P values that basically provided a range and not at not not basically like a like.
Like a single number I just want to clarify that that is due to the fact that.
Analysis is still ongoing and that was kind of like the topline results and we'll basically get <unk>.
Detailed.
Is that P values at the ESMO conference.
That's what I'm all just related to you. So our global she Oh Ah is a I call which are not in.
Charge offs on site selection and patient enrollment and also monitoring and.
Secondly, we're also using Covance central labs to look at all of our blood samples out to evaluate that.
The PK and also.
Blood chemistry, including the agency numbers, because you know the ANC actually it's important for all of secondary endpoint looking into the grade four neutropenia reduction in Annapolis verses, the Docetaxel arm and certainly I will also use I come TV to actually do that.
I say eat reporting and also compound also collect all the data for all the studies, including dumping story and also yeah and studies and all of the I T. T studies and the last time at least I also want to mention we also use our chi which is a.
Central.
Lab company and that you said that you.
C G machine to other sites too little Cat Churchill take Triple that's what you see G to look at the cardio safety you know for the for the drug so all of this as well validated.
And then also all conduct is under U S. T. C. P. So that answers. Your first question and number two is the data integrity. So actually would you use independent statistical company to do the analysis of the data and so and also just you know it's also a single blinded.
To the patients right. So the patient whether you look at the quality of life data you know it'll be very touch what types of patients do not know which arms. They are.
So that's the second question. The third question is you know great question, a clarification and before that she values in order so I'm most proud.
Pardon me and also the secondary endpoint, which we actually had released in the top line. Because this is a top line right.
We cannot disclose much because we're saving it for a big major medical conference, which is coming up in asthma. So that's why it was just only showing the ranch.
Yeah.
Okay, great. Thanks for.
For all the detailed explanations, but maybe just one more.
Kind of heading into the ESMO conflict I wanted to get your perspective on how you would view the PFS data obviously.
You look at OS, it's always kind of confounded by subsequent therapy, So maybe kind of a two parter one is.
Maybe can you comment on that.
Just on the geography, what are some of the subsequent therapies that patients could get on Dublin three and.
Also how would you kind of.
Interpreted and look at the PFS result.
In the context of the the positive okay.
Yeah that that's really a brilliant question.
Cause you know for the clinical studies I think the goal standards.
Because in the end, we want to provide a long term survivor what patients.
And that is you know what all the patients and the FDA and also physicians I'm looking for it. So <unk> is the gold standard but in the end but in addition, we also wanted to use them. Jeff as you know are no soldier to look how disruptive fact, right blood and Theres no noise from the later.
She threatened so so so that is what you are getting so do we see a jockey SEC, adding.
Adding to the guidance that the docetaxel in the fashion and I should say that P value is less than one restaurant that directional stops, Nevada, which we shared in the top line. So we're seeing better a improvement in the Netherlands, adding to them.
Docetaxel and not only in the PFS as that balance that's right and also in the whole lot, which also showed statistical significance in Europe last place you also asked about what's the later treatment after the.
The patients out of the study as you know it is a randomized studies so both arms that balance and patient after they get out but of course, they all do have a desire to live so you'll have a good.
Therapy to be cheaper so after what they usually use teekay is oh, so they do have PD, one PD L y exposures.
That's it.
And also about that got it.
Got it okay. That's helpful. Thank you very much.
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 theres been recent attention among investors that most of the patients in the trials were from outside the U S could.
Could you discuss with FDA is okay with the number of U S patients in the Cin Studies and then also can you discuss how closely the chemotherapy regimens used in most cin studies resembled what's currently used in the U S.
Well. Thank you so much Joe and thanks, well in Asia when they report.
So I recently, yeah. So this is a great question. So for the Cin indication as you know we're going after a broad label for Canavalin combined with just asked us Oh, preventing loss yeah Angie.
<unk> chemotherapy and all solid tumor right. So so it is a broad label and a steady while six phase III protect too is a pivotal study which supports this this label and you know additional also has five other clinical studies to support.
This label restaurant about safety point of view and also from cannabinoid pharmacology in itself walking Eagle.
Protecting neutrophil in week one after chemotherapy, that's what rich said is neutropenia vulnerability gods and that requires that she sees it as you said, Jeff couldn't protect but also represents over 75% of the clinical consequences, such as it's an authorization and.
As hard as fast.
And that's what Snapple and sports so coming back to the study design.
While six phase three study. This is FDA always wants to use a very harsh chemo such as T. A C in breast cancer to be a surrogate.
Chemo study to show the benefits Oh truck effect of any drug.
Which is in development. So if you look at all the Biosimilar G CSF.
Such as social yeah, Yeah, I'll use T. A C in the breast cancer, how to look at <unk> Pac why because even with the use of G. CSF J C. Do you have.
They are four neutropenia at around 83% to 93% and was true school, he's three or four neutropenia or 96% to 100%.
According to literature I suppose if there's a lot of room to improve there.
So, but then so.
So in that way, it's not so relevant to show.
Is she still used in the U S. It's more like it's using as a template to evaluate the drug effect, what canavalin combination when she says that any new current.
Any new agent in development for the Cin prevention, so coming back to the wild 16th Street location population.
It is.
Mainly coming from it sounds like two countries right around 50% in China, 50% round in Ukraine. So your clarification I, we're presenting the western patient and FDA agrees with that you know China of course, it's Asia a patients because you asked its just really use T. A C because T H E.
What did you catch that still have such harsh your question for neutropenia as high as 100%, so, but it's not really a U S very much in a lot of talk to your search that use for breast cancer and then.
But the western I suppose what you say Europe and China still Chi. It's just that's why you're carrying all patients to really evaluate up to happen that's a drug effect.
And so far FDA has long had any issues with this.
Tom because they have seen raw data. It also looks at all were on chemical combat.
And and Oh, So you look at the but you can imagine everything and this has not be an issue and they have successively.
<unk> accepted our filing was perhaps review and also it was no DAC.
Got it thanks for all those helpful details, maybe one more question related to discussions with potential partners for the U S and other countries.
Much of a focus on those potential partners is on marketing versus clinical development of additional indications.
Hmm.
Well, so I think there's probably.
Ongoing with potential partners for the U S global market potential cut to measure and this is of course, it's a combination of all of that right. Because it is very importantly forbade them. It's Sean S. Potentially now have just two of benefits.
Anti cancer benefiting extending survivor and also in reduction of chemotherapy.
Opinion was that profile. It really is a gateway into multiple indications and we believe in the I O combination therapy. So so of course part to that would be very interested in the in those additional development, which will give us a lot of potential for cannabinoid, Indiana is to help.
Many patients of course commercialization is near term right. So that's also in the discussion points, but as you'll see from our recent partnership deal with the highway which is a well respected company in China.
Oncologist phase I would do think that synergy is also giving us a one plus one with it too.
Theres discussion as you see from the times right. So you know commercialization, we are very much I'm grateful to Dara I support because they have top sellers of PD, one and also top sellers.
Docetaxel and Pops reseller of pets, the classroom, but also they have a lot of other.
Agents in the pipeline actually looks which could potentially also in combination with Nab. The cusp in Ireland is a very interesting and multi talented child being all away. So I'm going to have more indications and more differentiated therapy regime potentially for.
For patients in need.
Thank you.
Thank you for the great questions.
Has there been interest rate to ask a question you May press Star one. The next question is from the line of Joe Pesci. This with H C. Wainwright. Please proceed with your questions.
Good morning. Thank you for all the details and I think you've done a good job really addressing a lot of potential concerns that are out there. So thanks for that so.
So I actually have a couple of logistical questions first with regard to Hungary I'm just wanted to see you know what are some of the rate limiting steps right. Now I mean, you have got some tech transfer to do you know what are the things are outstanding to make sure that they could officially launch planning Abbie Laine officially.
Yeah, that's a that's a great question and that's what we're trying to actively doing anything with our China team is working with them starting from the second day from.
From the signing.
August 26, we'll have seen walking baby was.
Our partner at that time.
Right and they're very eager to get all of their medical science liaison team onboard.
Standing and also make him the you know the.
Messaging right understanding, but also the program of combat blend or the clinical benefit and also already designing stages for future indications.
And of course their commercial organization is very established and Oh, there's support of course the.
Pricing discussions as you know and the other insurance related matters with us.
That was very important for us.
Getting it ready to you know for the next time in commercialization potentially after approval.
Sure No I appreciate that and then my next question a relatively short maybe for Elizabeth is just regarding like the milestone payments. How are you looking to account for these you know and amortize or you know are recognized all upfront or what have you.
Yeah. Thank you for that question, Joe and we are very actively discussing that with the one who's our global auditor and.
You know, we we for sure will be booking all of the monies that come in we've not given up booking of revenue and yes. We will have to go through the dance with them on deciding how to book the revenue.
Understood and thanks for all the neat looking forward to ESMO sorry go ahead, yeah, and I was going to say on as far as the milestones go of course, you know those 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 and I will now turn the call over to Dr. Wang for closing remarks.
Thank you operator, I think you'll get if you want for joining us for the call today at what time is pressure and I. Thank you for being on this meaningful journey with us to support us and together you all parts of industrial how many patients in need. Thank you and have a nice day and a half nicely.
Kent.
This concludes today's conference you may disconnect your lines at this time and thank you for your participation.