Q2 2021 Athenex Inc Earnings Call
Good day, ladies and gentlemen, and welcome to the second quarter 2021 of Phoenix Earnings Conference call.
And now I'd like to turn the conference over to Tim Mccarthy of lifestyle advisors.
You may begin.
Good morning, and thank you for joining our conference call today, we will provide an update on the Phoenix This business as well as the review of financial results for the second quarter of 2 of 2021and.
The news release detailing the results crossed the wire earlier this morning and is available on the company's website.
A replay of this call will also be archived on the company's website.
The conference call the company will make projections or forward looking statements regarding future events, including statements about financial business and clinical milestones anticipated in fiscal year, 2021 and beyond.
We encourage you to review the company's past and future filings with the SEC, which identify specific factors that may cause the actual results or events to differ materially from those described and the forward looking statements.
You can find our SEC filings and the Edgar database at Www SEC Gov G. L. P R and the Investor Relations section at our website at Www Dot of Phoenix Dot Com.
This morning, we are joined by Dr. Johnson Lau, Chief Executive Officer, Mr. Jeff Gordon Chief Operating Officer, Dr. Rudolf Kwan, Chief Medical Officer, Mr of rentals, Dietz, Chief Financial Officer, and Dr. Dan Lang President of the Phoenix cell therapy the.
The management team will be available to answer questions. After the prepared remarks, I will now turn the call over to Johnson for introductory comments Johnson.
Thank you Jim.
There were several important developments and the feeling and the second quarter and I would like to come out of it this morning.
I wanted to discuss the progress we have made towards the.
F T 8 on order.
And the Paclitaxel plus and the second of all.
The ongoing commercialization of considering.
And as well as the recent Gol's Therapeutics acquisition.
Which is part of an ongoing plan to peal of persons in the cell therapy.
During the second quarter.
The.
The FDA to discuss the deficiencies and have been racing and the complete response letter we'd be sitting in February.
The F D a and encourage us to.
The development of oral paclitaxel for the treatment of the subject breast.
Breast cancer.
The key topic of Dmitry, what how we can potentially address the deficiencies racer in the C O L.
We are now evaluating the option of crude.
A new clinical study and working on the optimal design for such a study that we plan to present to the FDA later this year.
We are very conscious of course of all.
All of the capital and time requirements.
Ultimately, we hope days of patch that we can agree on debt is liable and.
And definitely the something very creation for all stakeholders.
Okay, well the plant our chief Medical Officer.
We'll provide more details later.
We continue to believe the oral Paclitaxel has demonstrated a very strong and compelling clinical profile.
And that it offers superior efficacy and safety compared with IV Paclitaxel.
If approved we intend to position <unk> as the chemotherapy of choice in mass.
Breast cancer.
And so we can send the our strategy for the metastatic breast cancer indication.
And it's important to remember that we have all the programs evaluating oral paclitaxel and additional indications and in combination with all of the centerpiece.
This increased our and 2 sarcoma study.
The combination with Pemble Lisabet study.
And the I spy 2 trial.
Again of the Quad will provide more details later.
History.
All the trip and the pollen O&M and.
Our first in class microtubule inhibitor for the treatment of the character of the face or Scott.
And launch it in the U S. In February led by our partner and morale.
And Roe per watt and updates on it.
And the launch progress on the.
The most recent earnings call.
The main focus at this point and the launch.
He is on gaming pay your culture and G. The U S to drive sales Wally.
We have the liked it you'll see that the series continues to gain market share and the a key market.
And that feedback from patients and the but.
Colleges Hudson and positive.
And Darryl highlighted the need for new therapies like ours different debt existing topical therapies are associated with significant side effects.
We are also pleased to report the Enbrel and recently received approval from the European Commission to market the theory and Europe.
This is another important milestone that will bring a new and in the lead treatment option to more AK patients.
And morale is preparing for the launch in Europe expected in the second half of this year.
We announced in July that we have signed the additional license agreements to commercialize the theory.
The Paris is the.
3 of C. S L will market the product in Australia, and New Zealand.
And the V of pharma is our partner in Canada.
These agreements are part of the game plan to develop a global presence for consideration and to expand access to more patients around the world.
And our Phoenix none of us.
Strategic partnerships for tip of the plan in place and.
The major market Inc.
Including North America.
Europe.
Australia, Japan and China.
In May we are quite a few of your computing.
Sure and develop a potential first in class NK and T cell therapy treatment for neuroblastoma, and slow and I know, what you need platform for hematologic and solid medical disease.
Just on technology license up on the Beta College of Medicine.
And the near term the acquisition of wisely Phoenix with true attractive assets with solid clinical data and potential additional data readouts over the next 12 to 18 months.
Importantly, there's also an opportunity to combine allogeneic NK and T cells with our T. C. L T cell therapy in solid tumors.
Acquiring 2 on ease of strategically you'd put at boot barn and Phoenix.
And consistent with our mission to bring in the wake of cancer treatments to patients.
It's becoming increasingly recognized in the medical and scientific communities and so far.
And if he holds the promise of being a game changer in the treatment of cancer.
Okay and then.
I'll start perhaps at the end of 18 of cell therapy.
And for what and updates on tour and discuss the progress mixes we make this acquisition.
There's also manage the update I want to discuss.
We have announced that Mr. Randall C.
Our Chief Financial Officer.
And it's given us notice and he will be leaving the Phoenix.
Randall and should make the decision to return to the financial sector.
We'll be initiating a formal search full replacement and CFO.
In the meantime, Mr. Steven Adams, our corporate controller will take on the role of interim Chief Accounting Officer.
Steve has been with the Phoenix since 2009.
And he is very familiar with all aspects of our business.
The financial function, you see and very capable hands.
Randall has to be a variable member of the team and I want to thank him for his contributions and wish him well it is the position.
Cash at the end of second quarter was $146.7 million.
And as stated previously we continue to assess very carefully about how to utilize and manage our resources efficiently and conserve cash.
Our current priorities are to maximize the growth potential for all of this country and cell therapy programs, while supporting our E. P. S. Slash a P D business.
Coupled with prudent cash management.
We continue to review our financing options and Opportunistically.
You will learn more from rental and the discussion on our financials.
We will evaluate all the scenarios for our business and remain focused on maximizing value for all shareholders.
With that I'll turn the call over to Dr. Rudolf Kwan.
Thank you Jonathan.
Let me provide some more detail on the type a meeting we held with FDA on oral paclitaxel.
We prepare the extensively ahead of this meeting and use all the time to discuss that the efficiencies race in the E. R. L.
Yes, the was supportive.
And I encourage us to continuously develop oral paclitaxel in metastatic breast cancer.
Daily at the rate, that's a well conduct the trial may adequately address the deficiencies.
And as Johnson mentioned, we are thinking carefully about the design of the nail trial and once the call that additional overall survival data this year.
We expect that we will be ready to share of our proposed trial design with the agency in the fourth quarter.
We plan to provide a third the uptake around that time.
As Jonathan indicated.
We are also power of pricing, how oral Paclitaxel program and the angiosarcoma and intend to discuss the registration pathway with the F D. A.
We have completed enrollment of 43 patients and our ongoing phase 2 trial.
As a reminder, we previously reported interim data at ESMO last year that showed the complete and parcel response rate of 27% and 23% respectively. In the 22 evaluable patients at the time.
Angiosarcoma is the disease with limited treatment options.
And for which all oral Paclitaxel has received orphan drug designation.
We will provide an update once we have clarity from the FDA on next steps.
And that's to our phase 1 study of oral Paclitaxel in combination with Pembroke Lakes of map study in solid tumor debt.
Those fighting the south from the study will be presented at the ESMO Virtual conference taking place in September.
Our abstract has been accepted for poster presentation.
We are currently proceeding into the expansion phase of the study for the cohort of lung cancer patients with plans to extend into a second cohort of guests of cancer patients.
Lastly, on the I spy 2 trial and.
And which oral Paclitaxel is being studied in combination with Glaxo Smith cries, the thorough method and carboplatin for neo adjuvant treatment and breast cancer. This trial is ongoing and progressing well.
I would now let's talk the 10 land and provide an update on all of cell therapy programs.
Thank you and rebel.
The acquisition of cure of Therapeutics was part of a major strategic initiative, that's on the nice to build world class capabilities and cell therapy.
We are excited about the potential of NK and T spot technology to improve clinical outcomes beyond what has been achieved by the first generation car T therapy.
We believe our NK and T cell technology is well positioned and the south of our IP landscape, because NK and T cells per thousand properties and attributes that may prove to be better than T cells or NK cells.
Unlike conventional T cells that could cause gvhd and K T cells don't have the classical of T C ours, which ran to the risk of gvhd and minimal.
NK cells typically have limited expansion potential following activation and it can be difficult to cloud reserve.
Conversely, the NK and T cells have the tremendous expansion potential both in vitro and in vivo.
And they exhibit excellent stability and functionality following cloud preservation.
And K T cells can also home to tumors and solid tissue, making them an ideal platform to a top of the solid tumors.
Lastly, and K T cells, playing an important role and propagating and amplifying the immune response by bridging the innate and adaptive immune systems.
Since announcing the acquisition and there has been smooth integration of the team and operations, which has benefited from synergies with the existing authentic south Hadley and infrastructure.
We have been actively working to converts the cure of academic and DS at Baylor to meet all regulatory requirements of an industry I and D.
Which will allow us to scale up and expands the current single center trial across multiple studies sites and accelerate patient enrollment.
The construction of our assortment of fashion on facility and Buffalo is complete.
We expect to begin running validation batches and the second half of the year with the aim of having the capability to support our phase 1 studies.
Pure of fossil 1 yourself how of that South puppy product currently in the phase 1 study and patients with relapsed or refractory neuroblastoma loans.
As the agenda get to trial.
We have now dosed up to cohort level for all of them like total of 6 cohorts.
We recently presented data at a S. D C. T Y we disclose 1 complete response, 1 partial response and 4 patients with stable disease out.
Of the 11, evaluable and heavily pre treated pediatric neuroblastoma patients.
Zero 5 O 2 hour of allogeneic product is being evaluated and the phase 1 trial in patients with Citi and 19 positive relapsed or refractory lymphoma and leukemia.
The 1 that's the anchor trial.
And sort of disclose at the time of the cure acquisition, we observed 1 partial response and 1 complete response and the first 2 patients treated at the lowest dose level.
We will be submitting an abstract on the study.
Which will include new safety and efficacy data at the Ash annual.
Eating.
The next cell therapy candidate to enter the clinic will likely be cure 5 or 3 and.
The other allergen day part of targeting G. P C..3 and have had on cellular carcinoma.
Plan to submit and R&D in 2022.
And our TCR T program, we have initiated a phase 1 and why he sort of trial and are expected to begin enrollment this quarter.
The study is testing and autologous hi, I've seen on T TCR T cell therapy and.
We are screening of patients with the NY ESO, 1 antigen, which is expressed on a variety of solid tumors.
Because NK T cells can express and kill tumors through engineered TCR Trans genes. We are excited about the opportunity to merge our TCE ours, and NK and T platforms and anticipate providing more news on this in the future.
In summary, there are significant and cell therapy clinical activities ongoing at the Phoenix.
And 2 studies with NK and T cells and why.
All of the hottest and achieve TCR T.
Well look forward to generating important clinical data and sharing that transformative potential about south at the platform with the medical community.
I would now turn a whole bunch of Jeff.
Thank you Dan.
We generated product sales of $21.4 million and the second quarter compared with $40.2 million and Q2 of 2020.
As we called out previously.
There was 14 million and now.
Non reoccurring revenues sold to other countries and 2 to 2020 and.
And that is the major reason for the difference and the sales results between the 2 quarters.
In addition, and the first half of this year there have been significant COVID-19 related challenges and on.
Our Indian supply chain and to a lesser extent and triangle.
As a result, we were not able to receive inventory from these regions for a certain period of time.
Other issues that are relevant and include the fact that the company experienced a higher amount of product sales and 2000 and 'twenty as we started fulfilling demand for certain drugs used to treat patients hospitalized with COVID-19 and demand for F. D. A shortage of products.
The product revenues and the second quarter of last year were particularly high given the Covid pandemic had just started.
We anticipate the there'll be several factors that will increase product sales and the second half of 2021.
These factors include new product introductions.
Better inventory positions as the Covid pandemic improves and India and try and and.
The improvement in shipping options from India and China.
Potential sales of shortage products.
New wave of Covid related cases will increase sales of both Apd and Aps and <unk>.
<unk> capacity in Q4 for Aps and continued sales improvements and a few key a P D products.
The Phoenix Pharmaceutical Division currently markets 34 of products with 61 Skus.
And if the mix pharma solutions markets for products.
With 16 Skus.
Construction of our facility and Dunkirk, New York is essentially complete.
We have built 8 dedicated base for the expanded 5 of <unk> business and plan to commence manufacturing there and Q4.2021.
Our current capacity at our clearance facility is fully utilized.
And these new base will substantially increase our capacity.
I will now turn the call over to Randall to discuss the financials.
Thank you Jeff.
Go through a few key financial updates for the second quarter.
Revenues from product sales in Q2 were $21.4 million compared with $40.2 million for the same here of last year.
As Jeff mentioned part of South of this quarter were affected by a decrease and demand for COVID-19 related drugs compared to last year.
And the second quarter of 2020, the Covid pandemic just started and we also recorded some significant non recurring orders of approximately $14.1 million.
And the first half of 2021 we also experienced COVID-19 related challenges and our Indian and China supply chain affecting the amount of inventories we can receive from our partners and these regions.
For the second quarter, we recorded approximately 500000 of license fees and other revenues, which included royalties received from an ROE on cash theory himself and the U S.
Cost of sales for the second quarter totaled $19.7 million.
Down from $33.3 million a year ago the.
The decrease was primarily due to the decrease and cost of product sales.
Generally in line with the decrease in revenue.
R&D expenses for the second quarter totaled 21 per 1 million compared to $22 million a year ago.
This was primarily due to the decrease in regulatory costs and cooperations and quickly cooperations.
The decrease and beef items was partially offset by increases and our of Paclitaxel and and stuck with our API costs and <unk>.
Preparation per part of loans.
The other with increases and truck licensing costs R&D of related compensation expenses.
Related to 5 O 3 D and cell therapy development.
SG&A expenses for the second quarter totaled $21.2 million and.
And increased from $17.5 million a year ago.
This was primarily due to increases and professional fees and all the expenses related to the current activation.
And as well as an increase and compensation related costs and operating costs.
These increases were partially offset by a decrease in costs for preparing to commercialize our of Paclitaxel as the.
And the second prelaunch activity occurred in 2020 and.
It slowed down upon receipt of the the are out in February of 2021.
Yeah.
And Q2, we recorded an income tax benefit of $11 million richness and income tax expense upon 1 million of sustained period of last year the.
Tax benefit and connection with the per acquisition that took place in may.
Net loss attributable to Phoenix for the second quarter was $34.3 million of 33 cents per diluted share and compression net loss of 45 million of 50 cents per diluted share for the same period and 2020.
In.
The part of South guidance.
Before we are limiting financial guidance to the existing athene ex part of portfolio only.
And 2020.
We recorded and this will come on and revenue from international customers as the result of the global pins on the.
With the Nazi these revenue is recurring in nature.
At the same time, we continued to expand our product portfolio.
We are now affirming the guidance we provided on May 6.2021, and currently expect that product sales in 2021, excluding any royalties from Kai series that he'd be in line with 2022 levels.
As of June 32021.
Phoenix had cash cash equivalents restricted cash and short term investments of $146.7 million.
Since the receipt of the CR out earlier.
Earlier this year.
We have started putting cash preservation measures in place, which include deferring commercialization related expenses and slowing down certain clinical programs the app.
And we have more car T from the F D a.
That's the result, we believe our cash will get us into the fourth quarter of 2020.2.
Finally, as Johnson mentioned.
Tendered my resignation as CFO.
And the passport year happier tremendously exciting period of Phoenix and it has been great to see the company ball and achieve a number of major milestones.
And that's been especially the awarded to have played a role and helping to advance and bring to market of innovative types of treatments.
I'm very grateful for the opportunity to work with the Athene ex board and management team as well as all of our investors and corporate partners. During my tenure.
For further details on our financials, including results for the 6 months and at June 32021.
I would refer you to our form 10-Q.
To be filed with SEC.
I will now turn the call back to the Johnson for closing comments.
Thank you Randall.
And as you have heard from the other members of the team.
A lot of developments and a few.
The extra day and multiple opportunities to create value.
We're thinking carefully about our overall strategy.
And the running scenarios across all of our divisions to determine how best to manage resources.
This would be in tandem with careful evaluation of returns on our scientific and business activities.
Regarding oral paclitaxel in metastatic breast cancer. We're certainly pleased that the FDA is supportive of a continued development.
And at the same time, we want to be realistic and recognized debt conducting either the large multiyear study in breast cancer may not be the best use of capital.
We will continue to work on the signing and optimal trial the dresses deficiencies in the C O L and explore additional pathways.
We firmly believe the oral paclitaxel and sometimes are compelling.
Compelling clinical profile and can potentially address significant medical needs in multiple indications.
We look forward to providing further updates.
We will now open the call for questions.
Thank you at this time of the conducting a question and answer session. If you'd like to ask a question. Please press star 1 on your telephone keypad, a confirmation tone will indicate your line is and the question. Kim you May press star 2 if you'd like to remove your question from the queue.
And for participants using speaker equipment and may be necessary to pick up your handset before pressing the star keys.
Our first question comes from the line of Robert <unk> with true Securities. Please proceed with your question.
Hey, guys. This is coupon on the line for Robyn. Thank you. So much for taking my question can you I know you mentioned that if it's the if it and.
The large controlling of the trial you you will have to think about it but.
Can you maybe provide some more clarity on what the book and are now in terms of how big of a trial would you go forward with them and.
What what additional color did you get from the FDA that can help you decide what sort of of trial and you would need to design and.
And as part of the timelines of contango is the 4 Q suburb of is there any any additional communication you might have with the FDA and between now and before you submit the design.
So the FDA. Thank you.
What's up.
Yeah. Thank you for your questions.
It is premature to discuss the timing of all of the scope of the study.
And Peel with the chance to agreed with the FDA I think that will become and what it is.
I would say.
Say that the F D a.
Basically reiterate the requests.
The proposal for a well conduct the study and.
And the focus is on safety.
So before between now and the fourth quarter, we intend to submit a proposal and have the FDA input. So once we have that input we will disclose the debt.
The Si does that at all.
And for your question.
Yeah, Yeah. Thank you and then 1 follow up question to what how many patients of data and what do we see and ethanol and what sort of duration.
They would be on can.
Can you maybe provide any color on what the expected ethanol.
Yeah.
We completed 40 and Roman of 43 patients and of course and not all of them would have.
Complete the study at the time of the ethanol so youll expect to see.
Uh huh.
A lot more than the 22 patients who at least on and that's cool, but not quite the full of 43 patient subset.
Great. Thank you.
Certainly we are looking at all options.
What we do.
Iterate that the FDA is very encouraging and supportive of development in the.
Breast cancer indication.
They also reiterate the.
The.
Pope.
And that the request for a new study in the U S. So we take all of those in the consideration and certainly aggressive the filing.
Yes.
Steel 1 thing that we will consider but it's.
We have to consult with the FDA as to whether that will be acceptable to them.
So I think that's all I can say at this time point.
Regarding the timing of the second quarter Youre, absolutely correct that the.
Both series Febrile neutropenia, thus of early and we believe we have.
The address.
The address that issue.
In the pivotal study, although the FDA would like.
Please specify.
Study in the U S and Thats, what we will be carefully looking at so tiny.
The timing it will depends on the ultimate design, but certainly that important safety signal is correct and occurring and the in the in the early part of the study.
Regarding the commercial aspect.
Certainly having a study in the U S. As the FDA indicate the 1 is certainly would have in the eventual commercialization.
That's the.
I guess would you have data from this study you have in mind and second half of 'twenty 2.
I think it's too early to define the study.
It depends on the defined that upset the boat with the FDA and certainly depending on the scope and the design there could be interim readout, but I cannot really go more and do that until we have an agreement with the FDA.
I guess, maybe asked a different way.
The complete response was back on March 1 and it was very clear that it is heading towards some sort of a trial for submission and what I'm trying to figure out is.
Have we lost time, how should we not have initiated the mid sized randomized trial in second quarter and.
Net of having to wait for FDA to tells whether the thing alarms et cetera, and I say that because that type of mid sized randomized trial was likely very relevant not just for regulatory but also of commercial and I would've answered all of these questions.
I think I think it's easy to.
Consider different alternatives.
And I think the.
Question is where to go to an agreement with the FDA what is required on the 1 hand, we.
The explore a more aggressive refining with a new study on the other extreme 1 could interpret the FPA 1 a repeat of the phase III program. So it is a dialogue that we we.
We are.
Ongoing with the FDA.
Efficient to say that I think we have a bit more clarity as to what the FDA and focus on which is safety and they have not and.
They have focused on repeating is the well conduct the study in the U S and that is why we are working towards with them. So I would not speculate whether we lost time of game time of whether we have the.
And what way to go retrospectively.
That's the.
Yes.
On color here.
And so very good with regard to all of our strategy is always important to remember that we we are working very closely with FDA.
With respect to Rick we shall authorities on working closely with them is actually a very important.
Approach that we are talking we respect the opinions and we're working with them together to resolve the differences in the interpretation of the data and such.
I mean, a range of studies that we can per watt and then for some of the best case scenario certainly we will have some of safety signal of already by the second half of next year.
Is the case in case.
Our our Sop most ideal subsidies on alright. Thank the hopefully answer your question. Okay. That's very helpful and lots of variables and there is a path of our second half of next year data.
Thank you surpassed per day of accusing right. Now you said I think we as you know we are always very conservative.
Early share data and <unk> and once we've agreed with the FDA is premature for us to make any comments here will have a good communication and certainly to be respectful to the regulatory authorities opinion and work together with the is always the most important component in terms of between short and the truck that we have your safety.
The population and you just helpful to patients. So I think we need to really be respectful.
Thanks, Dan. Thank you very much Jeff, Yes, I also want to add 1 more component and you set up on the last question by Robin about the asphalt and I think that Robyn was also asking with regard to the combination study or in terms of extra in the.
The <unk> said that you saw in terms of the combination of the companies just study I think that we will not mention the study on angiosarcoma.
Do you want to highlight with regard to the other study on the combination study that Robin probably was asking about.
Alright, Thank you Johnson and sorry for really.
Thinking about on the Lf study so the study for the Pembroke study the presentation in.
ESMO will include all of the initial dose expansion cohort and.
That is up around 20 odd patients altogether. So you ex expect to see all of the safety and activity data from that initial cohort and as we indicate the.
The study we have.
Gone into the expansion cohort of the first indication of.
Lung cancer and we are currently planning for the second cohort of the gastric cancer. So all of those initial cohort.
The initial safety escalation data on safety and activity will be presented in the ESMO.
And that will be to add some more color Ultra C..1 quick quick question will be whether we're going to put white data with regard to whether any of these patients were previously anti PD 1 non responders so to the dos Santos will be over the lifecycle of 80% of India.
External reaching as well with regards to you whether the combination of oral paclitaxel with anti PD 1.
And the efficacy in those patients who previously failed to respond to anti PD 1 monotherapy.
I hope.
We also had the question is the bulk of our OMA and Robin.
Thank you.
Thank you. Our next question comes from the line of Kennan Mackay with RBC capital markets. Please proceed with your question.
Alright, thanks for taking the question and.
Really.
Very very sorry to hear about the the resignation.
Maybe Ken.
Just help me understand what the goal of your second phase III trial or is it some sort of simple on the surface, but I'd love to understand your impression.
Hum.
And on whether the Fda's request for an additional study to understand racks of neutropenia profile. When it's managed U S supportive care.
Essentially the requesting you to run the same trial, but in the us with the U S support of care in line with U S guidelines or whether the goal is to determine whether a better risk reward profile.
And be achieved versus that which was achieved and the Latin American phase 3 trial, which I think and results from sort of a narrowed.
The patient population or entry criteria.
Obviously, those the spectrum of patient sensitivities and and risk of severe neutropenia. So.
Potentially.
Utilizing some biomarkers for recruitment or.
On label age of Comorbidities of medical history.
Which could delineate the patient population that might be at lower risk for severe neutropenia febrile neutropenia and can you maybe just.
Sort of help on which of those 2 scenarios.
Your understanding of the Fda's request, there is or if it's something else altogether.
With that.
Kevin the.
Beth.
And.
Income rotation, we have from the Cri laughter and from.
The type a meeting and set the focus of the FDA is in safety data.
The U S population.
From a study that is well conducted so I think that is where we are.
January of 40 January of optimal design to address that.
Does that help.
Okay, and maybe more like the.
And the sort of former that they're asking for.
Just on understanding of.
What what the safety looks like when it's managed.
The U S standard of care and rigorous supportive care.
I think would be my interpretation of the intent and the.
The U S population, which basically means using the U S.
Medical.
Practice, which day.
Because of the study did not include and the U S.
And if the study I guess that is the kind of the sub pockets safety data. They are looking for and that is what we are trying to design the study to help them to understood.
And those data.
Understood and would it be possible to include either as the.
Subgroup or.
The stratification of the enrolment of portion of patients who would be anticipated to be at lower risk of of severe neutropenia or are there any.
<unk> upfront debt.
Could enable enrollment of those patients.
Only asked and took that could provide sort of the hubs.
Back up.
Chart on on goal if there is still febrile neutropenia and patients at high risk of neutropenia.
Then that could potentially provide a path to market and patients who are potentially and lower risk again.
If the risk reward is advantageous for those patients and again, obviously, we know the efficacy of <unk> to support and some of that.
Yes.
What are the.
Oh, sorry.
Canada is a very good question and this is what we are looking at.
And that.
And with additional and analysis subgroup analysis and that will all be putting into the planning of our proposal to the FDA. So we certainly are.
Take all of those considerations and our current.
Additional and analysis.
Got it and then maybe just 1 final question.
Obviously, you talked a little bit about sort of backup shots on goal as I mentioned.
Without him on what are sort of the next steps for the angiosarcoma.
The program cannot drop the 2 trial be expanded into a potentially registrational trial and have you talked to the FDA yet about the path forward and angiosarcoma.
That's exactly what we intend to seek.
Input from the FDA on the path forward bear in mind and your stock.
As a.
The treatment is the <unk>.
And that has no approved treatment as we speak and ease of very aggressive.
Therapy, and it has not come and it's a rare disease orphan drug indication. So 43 patients is not a small number so we intend to part with the FDA, what will represent and approvable package for an indication. So we will be talking with them.
Got it.
Apologize go ahead.
And then I just wanted to ask some kind of here obviously you have hurt what we'll do.
I was trying to communicate.
Everybody with regard to the effect that the current discussion with FDA was positive FDA was encouraging us to further develop they see the value and the propane I'd like the profile of what we have but certainly we have to address the concerns now if the concern is safety and the sort of you saw is only focused on safety.
So therefore to embark on 2 of study with our hedging of good communication of FDA will not be and ideal situation is always face to half of the brewery.
Some of these I hopefully not a big 1 and then that actually it will allow us to of a salaries of the path going forward with FDA together now in relation to debt with.
I'll also mention that the use of alternative path with regard to angiosarcoma. So how to balance is true in such a way that we can satisfy fda's concern and the same time, giving the product the best path forward for approval I think debt we are.
In the very interesting position, we have more than 1 path and then we have multiple opportunities and were trying to sell and make the right decision. So as to use of capital and time efficiently too for this product to be available to patients I think that summarize actually the different way rooftop solar comments.
Kevin.
Absolutely totally understand.
Maybe just a follow up on the sort of the the origin platform several years ago you're on.
R&D day.
You talked a little bit about some next generation.
PGP pump inhibitors that the cause.
And then improve on what we've seen with <unk> plus oral paclitaxel and could you maybe talk about sort of where those are and in.
The development in terms of again sort of the next generation <unk>.
<unk> potentially.
Moving into the clinic.
And looking forward to hearing more thanks.
Okay, and then let me address the question so with regard to the oral Paclitaxel and the next generation is deal with EBITDA exhibiting both of the peak of proteins as well as the testing the 384 and the science. So therefore is more sort of you signed for oral Docetaxel English docetaxel is of 3.
A full substrate they sort of come 3.8 for substrate with regard to our oral paclitaxel and we do have a tablet formulation, which we can load more of the paclitaxel in the ongoing or the.
Public what kind of studies already completed and the data will be presented at the appropriate time, where do we stand right now and you said we have a.
The capsule formulation ready and is doing very well and we did it.
The profile looks really really good and then just sort of the development of oral Paclitaxel and we'll get more in line with the tablet formulation.
So for oral Docetaxel, which we are showing very good phase 1 data that 1 will be a perfect substrates and when we.
The city, our second generation, which were kind of extension up to <unk> <unk> or so of 2035, I mean, I think that is the.
And the path forward in terms of the but I think this first and second Gen generations P GP pump inhibitor.
The question Kenneth.
Yes, thanks, very much on sort of Rudolph. Thank you. Thank.
Thank you Kevin.
Thank you, ladies and gentlemen, and as a reminder, if you'd like to join the question queue. Please press star 1.
And on your telephone keypad.
We ask that you please limit yourselves to 1 question and 1 follow up so that we may allow for as many as possible.
Our next question comes from the line of Kevin <unk> with Oppenheimer. Please proceed with your question.
Hey, Thanks for taking my question, Yeah, I'll try to keep the surface.
Maybe 1 for Dan can you talk a little bit of out the curve or.
I guess, the 5 of our free the HCC program and for moving forward.
How youre thinking about target product profile on there.
And.
And just a little bit more on with regard to.
From.
Structure on the profile standpoint.
How simple.
And similar of the contract as soon as the 2 clinical stage programs. This year and license as part of our growth you acquired the part of the acquisition.
Okay.
Sure Hey, Kevin Thanks for the question so far.
GTC 3 car NK and T. We are planning to submit the IND sometime in 2022.
And the target profile of the drug that we're looking for is.
Hopefully that will serve a balance must be more benefit.
All of these patients to have been a little.
Options on 8 months.
And some of the first line and second line treatments on really desirable and the clinical efficacy and she can go on and stuff.
And the optimal.
And liver cancer and he's a very large indication primarily outside the U class. So.
And once we have more information on the.
Preclinical data, which is still ongoing and will be able to pull by the more information about the.
Can you talk of the profile of this product sometime next year.
And then I think you highlighted.
Thanks, Joe.
And our submission of our Ash in December I, just want to clarify that balance that was for anchor.
And just more generally.
And we think about number of patients and and scope of that potential out there.
Sure. So yes, the abstract and then we have submitted to ash and it's for the anchor study as a reminder of weakness and say allergy and Nick sitting.
CD 19 car NK and T cell when we acquire a tier of our back in May we had and still on staff out of.
Communications.
And were enrolled so far at the lowest dose of 10 and.
700 of them per meter square all of them.
These 2 patients and we saw 1 PR and once you're on.
So Kevin and I expect to see and more patient data at Ash and website.
On a chip design.
The safety and spas and ethical seat of the.
The.
Ongoing.
Clinical experience and we have so far.
Thanks for taking my questions.
Thank you Kevin and thanks again.
Thank you. Our next question comes from the line of Yale Jen with Laidlaw and company. Please proceed with your question.
Good morning, and thanks for taking the questions.
I have 2 here the first of all of you mentioned that you will combine the TCR T and NK E.
Platform together I'd, just like to go live and more color in terms of what the specifics that you are thinking of.
Okay.
So thank you for the question. So as you know, we have and the high affinity TCR that targets the.
And why E antigen.
And that is expressed on the number of different cancers, including lung cancer, and head and neck cancer Triple negative breast cancer. So 1 scenario could be for us to combine the TCR debt, we have against NY ESO, 1 of the NK and T cell platform. So that we would have a <unk>.
Unique approach targeting NY ESO.
And that will be able to we can pass that and a solid tumor indication.
Well, we are already have some preclinical in vitro and in vivo data to show that these NK and T cells could.
Performed quite well.
When you and certainly Charles gene debt.
Hum.
That.
Has the TCR sequencing of them and we've been able to show that these NK and T cells and T cells are able to kill tumors and cell lines and also in vivo.
1 other thing going on to kind of remind everybody is the NK and T cells have a great ability to homes and the tissue.
Primarily tumors and particular lever.
In humans, it's SD.
Some of the up to about 10% of 50% of NK T cells on residents within the liver.
Okay great.
Very helpful. Maybe 1 more question here is debt.
Let's start the TCR T E zone 2.
The trials in this quarter.
Could you give us a little bit more color in terms of the study design and.
And any other color related.
Sure so.
This is the phase 1 study primarily looking for safety.
The visits a high affinity TCR and targeting against NY, ESO and they'd say autologous T cell approach.
Since we already have some clinical data from our partners, we actually starting at of our high dose and 1 billion cells.
And our first cohort and then I think the next dogs and <unk> billion and then go into the $10 billion.
And we are looking to enroll patients with the NY ESO antigen for which we have developed a proprietary IFC study on <unk>.
The test to and which for those pop those patients asphalt on those patients that are the happening HLA 18 subtypes.
There are 5 different solid tumor indications and we're going after and they include non cancer head and neck cancer.
Some of them and sarcoma triple negative breast cancer and basketball.
Yeah.
1 last 1 is the.
Net of a parcel.
Okay, Great and I assume you were looking for the signals as well.
And the 1 point of the study.
Is that correct, absolutely, yes there'll be.
Obviously correlated studies relating to PK of both on the blood and hopefully on the tissue as well as the traditional scans and the imaging that you would expect for a phase 1 study of this nature.
Okay, great. Thanks, a lot of really appreciate it.
Okay.
Thank you ladies and gentlemen, this concludes our question and answer session I'll turn the floor back to Dr. <unk> for any final comments.
Thank you everyone for joining us today.
We will continue to work with the FDA on the wide at the path forward for oral paclitaxel in metastatic breast cancer.
And the same time, we are working on additional paths of oral paclitaxel and orphan drug designation.
With the compelling clinical profile demonstrated by this drug candidate we are.
Also excited by the progress seen in ongoing study of oral Paclitaxel in combination with <unk>. This summer.
Our cell therapy programs are advancing nicely and we look forward to sharing more clinical data in upcoming scientific meetings.
On the commercial front cause series has already received regulatory approvals in both the U S and Europe.
We have established partnerships in all key geographic areas around the world, which will help bring this variable therapy to more patients in need.
We appreciate your attention and interest and look forward to providing more updates in the near future. Thank you.
Thank you. This concludes today's conference you may disconnect. Your lines at this time, thank you and your participation.