Q1 2021 Athenex Inc Earnings Call
Welcome to the Q1 2021 at the next incorporated earnings Conference call. My name is Richard and I'll be your operator for today's call. At this time all participants are in a listen only mode. Later, we will conduct a question and answer session.
During the question and answer session. If you have a question. Please press Star then one on your Touchtone phone.
I will now turn the call over to Mr. Steven Rubis Senior director of Investor Relations. Mr. Lewis you may begin.
Good morning, and thank you for joining our conference call today, we will provide an update on the Phoenix business as well as the review of financial results for the first quarter of 2021.
The news release detailing the results crossed the wire earlier this morning and is available on the Companys website.
A replay of this call will also be archived on the company website.
During the conference call the company will make projections or forward looking statements regarding future events, including statements about financial.
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 in the forward looking statements.
Can find our SEC filings in the Edgar database at Www Dot <unk> dot Gov or in the Investor Relations section at our website at Www Dot a Phoenix Dot com.
This morning, we are joined by Dr. Johnson Lau, Chief Executive Officer, Mr. Jeff Jordan, Chief Operating Officer, Dr. Rudolf Kwan, Chief Medical Officer.
Mr. Randall C Chief Financial Officer, and Dr. Dan Wang President of Athene ex cell therapy, who will be available to answer questions. After the prepared remarks, I will now turn the call over to Johnson for introductory comments.
Thank you Steve.
I will provide an overview regarding our efforts to address the complete response letter of for oral Paclitaxel.
And updates on two series of performance and do cool Therapeutics acquisition.
Before turning the call over to our Chief Medical Officer, Dr. Rudolf Kwan.
The top priority remains addressing the complete response letter we received from the FDA for oral Paclitaxel and.
All of February.
Oh for the past several weeks the.
Organization was it diligently to collect additional data and performed additional analysis to support our risk assessment.
Of the Texel.
We plan to request the type a meeting before and for me Andy.
Expect the FDA the scheduled the meeting within 30 days.
And the type a meeting we hope to better understand the agencies' concerns expressed in the complete response letter.
As well as to align with the agency all of the optimal pathway for the required to obtain for approval.
We continue to believe.
Both debt oral paclitaxel demonstrate the a very strong clinical profile and that it offers superior efficacy and safety compared with IV paclitaxel.
If approved we intend to position it as the chemotherapy of choice you make.
So the breast cancer.
This theory on.
The first in class microtubule inhibitor for the treatment of actinic keratosis or 8-K of the face of Scott.
The launch in the U S in February.
Led by our partner Emerald.
The simple approval and subsequent launch Oscar theory represent important milestones for you of Phoenix.
The series with the same Steve first pulp price is the next product <unk>.
Company successfully progressed from discovery through FDA approval.
Considering.
With the sense of a significant step forward in the treatment of AK steel to shop phosphate shipment protocol off on that.
Efficacy and safety profile.
H index returns attractive economics around the company's partnership with the MRO focus city.
In addition to the $50 million in upfront and additional milestone payments already received prior to the first quarter of 2021.
Our Phoenix, we see.
The 20 million milestone payment in the first quarter chicken of by U S launch of cash series.
Eligible to receive up to an additional $45 million in aggregate milestone payments associated with the consumer launch and expansion into additional indications.
Additionally, the.
Company is eligible to receive sales milestone payments and is eligible to receive tiered royalty payments starting at 15% of annual net sales.
On may 4th.
Not for the acquisition of pure of Therapeutics in the primary all stock transaction totaling $70 million, what's the additional consideration of up to $115 million in milestone payments.
Sure has developed and even the way to allogeneic NK T cell therapy platform.
Based on technology licensed from the Bader College of Medicine.
Do you cure platform complements <unk> existing cell therapy program.
Is evaluating an autologous.
Autologous high affinity T cell receptor or TCR T cell therapy, pocketing solid tumors expressing NY ESO one.
Sure.
Due to the acquisition, but what's the opportunity to apply an allogeneic approach to our T cell program in solid tumors.
I have also talks of 10 Lang, our president of the Phoenix cell therapy to join us on the call today day.
David will provide additional details on true ups and the associated opportunity in a few minutes.
Our specialty pharma business Apd and Aps.
Continue to perform well.
We now believe is a compelling opportunity to grow this business further.
Our cgmp facility in Dunkirk, New York is nearly completion and once this becomes online it will expand our capacity.
Given the complete response letter, we're ticking industrial actions to manage our resources efficiently.
The cash.
Once we have sort of clarity from the F. D. All of the regulatory pathway through the actions will be kicked in to prioritize and invest.
Our resources effectively and efficiently to create value for shareholders.
S. Investors may appreciate we are in experience and pragmatic cheap and are actively evaluating multiple scenarios for our business to maximize shareholder value. During this uncertain period.
Given what we know to date our cash.
Current parties to bring oral paclitaxel towards successful regulatory outcome and to advance our cell therapy programs.
While supporting our Ats Slash Apd business.
We are balancing this powerhouse of kings prudent cash stewardship.
We seek to extend our cash runway.
The rental will provide more details in his discussion of the financials.
I will now turn the call over to Dr. Rudolf Kwan.
Thank you Jonathan.
Despite the whole of disappointment regarding the CRM.
We are working diligently to address the CRM and to fund.
Oh it for.
Oral paclitaxel.
Let me begin by providing some detail on how we plan to respond to the CRM.
For the past several weeks.
The team and I have been working to develop our response to the FDA.
Our preparation include developing additional analysis.
And collecting additional data to address the agency's questions and concerns in the CRM.
Additionally, as part of our preparation.
With engaged several advisors and consultants Inc.
Including record <unk> and both statistic of advisors to assist us.
We are finalizing our meeting request submission package.
And our plan is to submit the type a meeting request by the end of May and.
And expect to have had the type a meeting.
At the end of the second quarter.
We continue to be hopeful that we can reach an agreement on the path forward that addresses the FDA consent outlined in the CRM.
We will provide an update regarding the outcome of all the FDA meeting.
Upon the next steps to the list of commodity when available.
We continue to advance oral paclitaxel programs.
Including cutaneous angiosarcoma and oral paclitaxel in combination with Penn bullish on that.
And the I spy two program, where oral Paclitaxel is being studied in combination with gsk's they'll stand of map for new adjuvant treatment in breast cancer.
On a program in cutaneous angiosarcoma continues to progress well oral paclitaxel as the received orphan drug designation for this indication.
And we plan to request the meeting with the FDA to discuss the regulatory path forward.
We will provide an update on the discussion when regulatory clarity becomes available.
The dose finding portion of a phase one combination trial of oral paclitaxel in combination of 10 bolus of map is complete.
The clinical trial of <unk> oral paclitaxel plus penalties of met in the advanced solid tumors.
We expect the please send a dose finding data later this year.
We are currently proceeding into the expansion phase of the study for the cohorts of the lung cancer patients.
With plans to expand into the second cohort of gastric cancer patients.
In terms of clinical trial presentations.
We are presenting three apps.
ESCO in Q1.
The first abstract pertains to of Phase one study of oral docetaxel in metastatic prostate cancer.
The second set is on PK interaction of and second of all on dike appetite.
And the set upset on the analysis of tumor response.
The molecule type from the phase III study of oral paclitaxel in metastatic breast cancer.
I will now turn the call over to Dan.
Thank you Rudolf.
Fourth we announced the acquisition of the Qunar therapeutics, the leading developer of Allogeneic car T cell therapy the.
The acquisition of true bolsters authentic existing cell therapy program.
We have been looking for a potentially disruptive technology for almost a year.
And we have spent significant time evaluating the second technologies and cell therapy that could be synergistic with our TCR technology.
I would like to walk you through what U S to this innovative platform technology.
While the current first generation of autologous car T approach has generated compelling clinical safety and efficacy.
That remains several of limitations, including extended manufacturing time patient.
The patient to patient variability.
Costs and relative mixed data on solid tumors.
We've been on each one of the key elements of success for of leaving some kind of the company in the future.
We acquired an off the shelf allogeneic approach.
We believe course NTT cell technology could be a transformative platform.
That could lead for current first generation cell therapies.
We believe NK T cell is an ideal cell type to be developed as an allogeneic cell therapy.
NK T cell attack low graft versus host disease from risk because they don't have the classical tcr's.
NTT south of two important anti tumor effects.
They have direct type of tactical effects on sales like NK cells.
In addition through their interactions with dendritic cells and T cells can recruit and activate NK cells and T cells through the will meet the of cytokines.
The Capex gaming the Cascade of immune response.
Our goal is the first demonstrate that NK T cells by safe by utilizing a panel of this approach.
We are doing in the genome to face when neuroblastoma trial.
This is the car NK T targeting <unk>, two which is providing the expressed in neuroblastoma.
In January of 2021.
For this goes back 10, Evaluable patients one complete response and one partial response have been observed.
Got it back from a well tolerated.
Additional data from the <unk> phase one trial will be presented at the American Society of gene and cell therapy conference on May 14th.
The second clinical program car NK T targeting CD 19 is being studied in the anchor trial.
This is an allogeneic program and that the sales came from of healthy donor.
The anchor trial of Phase one study in adult patients with relapsed and refractory lymphoma and leukemia.
Oh, the two evaluable patients.
One CR and one PR happening of observed at the lowest dose level of one times 10 from the seven sales per meter square.
Yes, the Phoenix cell therapy program began two years ago with a joint venture with ex-wife sciences to evaluate an autologous affinity of enhanced TCR T targeting NY ESO in solid tumors.
The future of exciting opportunity room revolves around the ability to transduce tcr's onto the NK cell platform to address the unmet medical need of solid tumors.
The only does get the acquisitions bolster the Phoenix cell therapy platform.
Also allows us to leverage the preclinical clinical and manufacturing resources already presence within the obtained thanks to further advance curious pipeline of assets.
While our company continues to work on advancing oral paclitaxel to the finish line.
The acquisition of cure illustrates our commitment to the Phoenix cell therapy program and to unlock value for our shareholders.
I will now turn the call over to Jeff.
Thank you Dan.
I will provide an update on current developments within our infrastructure and supply chain.
And the existing commercial business.
The Phoenix specialty pharmaceutical business generated product sales of $20 million in the first quarter.
The COVID-19 spike in the fourth quarter.
Had a negative impact on our first quarter results.
The impact was manifested by hospitals ordering excess inventory in Q4 2020 to.
To be better prepared for the pandemic.
The significant spike in COVID-19 cases in <unk>.
India.
Causing long delays in receiving inventory from our partners.
The biggest contributors to the sales growth recently have been products such as the extra time again.
The zip through myosin.
The Brazil, and Tesla back for them.
And Levothyroxine.
We also recently launched a room temperature stable cyclophosphamide.
Which has significant advantages over competitive products.
The <unk> pharmaceutical division currently markets 30 for products with 61 Skus.
And the Phoenix pharma solution markets six products and 19 Skus.
Construction of our facility in Dunkirk New York.
Is nearly complete.
The facility will serve the commercial needs for our specialty pharmaceutical business.
Beginning in the fourth quarter of this year.
We plan to commence manufacturing of $5 three D products and a portion of that facility.
The equipment for this expansion of our Aps business is already in the Dunkirk.
We are now working to hire a team to operate the equipment.
In Chongqing, our manufacturing facility.
We will complete all validation activities in the second quarter.
The plant should be ready to commence manufacturing Inc.
Q3 of 2021.
We continue to take a hard look at the opportunities available to grow these businesses.
Our analysis identified a range of products of particular interest.
And we are acting on these products.
Currently.
The Phoenix specialty pharmaceuticals relied on partnerships as a source of new products.
The next logical step is to develop our own products.
That we own the andas, allowing us to launch products at market formation and substantially increasing our margins.
We will also be adding to our product line oral oncor of it.
Which allows us to take advantage of the existing relationships, we have ecology market.
Developing and launching proprietary products.
We'll continue to be the cornerstone of the Phoenix of strategy.
Our manufacturing facilities.
The technical Knowhow as well as deep relationships provide of scale advantage to our specialty pharma business.
We continue to look for opportunities to leverage these competitive advantages in a way that will unlock value for our stakeholders.
I will now turn the call over to Randall.
Thank you Chad.
Go through a few key financial updates for the first quarter.
Revenue from product sales in Q1 increased to 24 million of year over year increase of 10%.
Primarily attributable to an increase of sales of $5 to be part of it.
API part of sales increased.
Europe on $8 million.
These increases were offset by decreased $2 3 million APB sales.
For the first quarter, we recorded $20 million of license revenue.
Pursuant to the 2017 annual license agreement.
Upon the launch of the theory, and the U S and half of million related to the upfront pursuant to the second amendment.
The 2011 from essentially license agreement.
Cost of sales for the first quarter total of 16 4 million.
Down from $19 6 million a year ago.
The decrease was primarily due to the $2 million royalty payment to hunt.
In 2020 on the license revenue from some share.
R&D expenses for the first quarter totaled 23 for 1 million up for.
From $17 2 million a year ago.
Increase was primarily due to an increase on prelaunch of product development costs.
The clinical operations cost.
This was partially offset by a decrease in clinical study.
In patient cost on the oral paclitaxel off the completion of the phase III study.
And as well as increases in regulatory and price development and five years through the development cost.
SG&A expenses for the first quarter 2021 total of $22 1 million.
Down from 25 7 million a year ago.
This was primarily due to a decrease in cost of preparing to commercialize or of Paclitaxel.
And if it's on prelaunch activities occurred from 2020.
On slowed upon receipt.
In 2021.
This was partially offset by an increase of general and administrative costs related to increased hiring quick question on.
It costs and other operational costs.
Net loss attributable to Phoenix for the three months ended March 31st 2021 was <unk> 25 per 1 million or <unk> 27 per diluted share.
Net loss of $19 4 million of 24 per diluted share for the same period from 2020.
As of March 31, 2021.
The company had cash and cash equivalents of 48 million restricted cash of $16 5 million.
And short term investments of $123 2 million.
At the result that we have taken initial steps to conserve cash and we identified several opportunities for cost savings.
One opportunity of Phoenix oncology.
The launch expenses can be pushed out until we have greater clarity on possible approval and path forward.
In addition, the opportunity exist to reduce capex expenditures as well as certain non core R&D and CMP call.
Considering the various adjustments and based on our current operating plan.
Not that our cash and cash equivalents can fund our current operations into the second half of 2020.
In terms of product sales guidance. The company is limiting financial guidance, the only the existing product portfolio, which excludes any proprietary products on two meaningful sales data from the <unk> product could become.
Become available.
In 2020 the.
The company recorded a significant amount of Robinson from.
International customers as a result, the global pandemic.
However, the company does not heating revenue recurring in nature.
The company continues to expand its part of portfolio.
The company the affirming the guidance provided on March for 2021.
It currently expect quota sales in 2021.
<unk> and royalties from <unk>.
The in line with the 2020 levels.
I will now turn the call back of the Johnson.
Thank you Randall.
I'll now open the call for questions.
Thank you you will now begin the question and answer session. If you have of questions. Please press Star then one on your Touchtone phone if you wish to be removed from the queue. Please press the pound sign or the husky.
If youre using a speakerphone you may need to pick up the handset first before pressing the numbers. Once again if you have a question. Please press Star then one on your Touchtone phone and we're standing by for questions.
And our first question on line comes from the robot from Evercore ISI. Please go ahead.
Hi, This is Paul Thank you for taking our questions.
One for <unk>.
And Jonathan could you elaborate on what additional data collection and analysis of going.
For the oral Paclitaxel regulatory.
Pathway for the additional data does that.
And some more data from the phase III.
Cancer trial or from other trials that half of U S sites.
And for the additional analysis does that include the sub analysis that youre going to present at <unk>.
Or some kind of population PK analysis. Thank you.
Thank you.
Yes. Thanks.
For the question.
Additional data collection and analysis.
To address the FDA concerns in the CRM and these include.
Data related neutropenia related <unk>.
The primary endpoint of objective response rate.
The price of <unk>, ICL and additional risk mitigation strategies to improve toxicity.
Regarding to the ESCO question in the <unk> will be providing molecular subtypes of.
Data regarding to the who on one study and that data.
I am not new to the FDA. So that is not part of the analysis and the submission.
Sure.
Okay.
Thank you. Our next question on line comes from Mccann <unk> Mackay from RBC capital markets.
Hi, Thanks for taking.
Taking the question.
Just wondering if you could help us have you had any.
The conversations or exchanges with the FDA since the.
Relative to clarify some of the.
Feedback from the SEDAR all I know that was certainly a question last time.
We have spoke and then secondarily the bad.
We have seen obviously the walk away from their oral paclitaxel, paclitaxel or oral taxane sort of type of.
So after.
The FDA had asked for an additional trial, though additional guided there.
Just wondering if that something that could even be on on the table here or.
What differences you see between.
The trial that they ran on their FDA feedback perhaps versus.
The situation that Youre, Inc. Thank you very much.
Thank you Kevin on without.
Yes, Kevin.
First question Lee.
Waiting to talk with the ft on the CRA all based on the meeting request.
So we have no additional exchange yet as we speak so the mix exchange will be at the meeting.
At the type a meeting, which we shall be requesting.
Regarding the both the Nate.
As a result.
All right.
I'm kind of company policy that we do not comment on other companies' products and certainly.
I believe we will have the only interpretation.
The interpretation that we have a company policy thats certain aspects of it will not be sort of <unk>.
Both of them became comments and the hope.
Hopefully you kind of just kind of.
And thank you.
Our next question on line comes from Jonathan Chang from SPP SVP Leerink. Please go ahead.
Hi, guys. Good morning, Thanks for taking the questions.
First question I guess just to follow up on the previous questions I mean, how do you of any.
On next steps for <unk>, how do you think about the different scenarios that could play out and whether or not you would proceed with the development of the program.
Thank you for the question Jonathan certainly.
We now have a complete response letter from FDA.
Essential for us to do Outback two per watt additional analysis for what additional data to try to address fda's concerns. So that we can now move forward with.
Uhm and I'm also curious to know how the correct position impacts for existing TCR sell therapy efforts. Thank you sure of the <unk> before I turned it to a Doctor day, and then to share that is the our philosophy and also what we have seen leave behind it to the fact that I mean, I think there were a lot of <unk>.
She is where if it got you all of the timing with regard of doing such a child section maybe emphasize of that the of the source of a Phoenix is trying to develop the best case of therapy for patients will have been developing.
And the strategies, where he got you.
Reading value for the out sick holders and Dan are the rationale behind.
And the timing of it if it got too of how we actually evaluate and also to of to take this opportunity. We've heard this to talk to the link to address the question.
Uh huh.
Thank you Johnson's hi, Jonathan.
So we actually.
And barked on evaluating different technologies that could really augment our current TCR T program.
When we did an analysis on one of the key elements of success for a future of leader in cell therapy, we believe the having the off the shelf allogeneic approach is a very critical elements.
Current generation of car T's have.
Interesting efficacy on safety data that are helping patients, but they also have the limitations considering the long manufacturing time, the costs patient of patient viability.
And the other limitations that I'm sure you're aware of so we over the past nine months, we've been spending a lot of time looking at different technologies and companies to.
Try to bring in to bolster and enhance our currency CRT program and we really believe correct therapeutics is one of those transformative technologies Tech help us leapfrog current first generation Carty therapies.
And when you ask the question on the harvest is complement of of currency CRT program.
One could put of TCR on to the N K T cell platform.
Could allow us to have an off the shelf allergy nag approach to to address the unmet medical need for solid tumors. So I hope that answer some questions on.
Two on Jonathan.
Be a little bit is that the.
Seven patients that have enrolled in the study.
We really cannot discuss further information on the data ahead of the <unk> confidence because of the embargo.
The longest duration of response that we have so far in the study it's about six months and then in terms of the cash question I would defer to you the Johnson the or Randall.
Do you want you of made a comment on the cash position and on and the confidence that we are going to be able to execute on all fronts based on our current projections random.
Yeah sure. Thank you Robin for the question.
So our latest cash flow and we guidance actually account of for expenses associated with the advancing ourselves 30 programs, including the care of platform.
And ever since.
The the C. R out we happening very cautious and we have been an income very carefully about how to manage all of the resources efficiently and effectively and.
And we've been trying to conserve cash until we have more clarity on the path forward for our pocketbooks of them.
So we've been actively violating multiple scenarios for our business to maximize not to maximize shareholder value. During this on certain period. So.
So our carbon power teeth are to maximize the growth potential for our Orange cuddly pie for an hour of south therapy programs and at the same time, we're continue to some proud of Aps an apd business.
Well where be bought anything these parties against pud in caps of allocation as we speak to expand out for predicts then I would cash flow with you on your term Catholic.
The hopefully that addresses your question on on the cash for all of it.
Yeah, and then on manufacturing I mean, obviously.
I know for alginate with the little cheaper, but even so these are expensive therapy. What is the current status of your manufacturing ability for the new car T N N.
And K T cells car N K T cells, and how if someone else manufacturing for you do you have it in the house.
Sure. Thank you Robin so.
For both of the face one clinical programs the genetic of two for neuroblastoma and the placement program the anchor city of for it's the the 19 positive with US refractory lymphoma. Both of those studies are supported by the GMP.
Baylor.
Manufacturing facility in Houston.
And we're actually in addition to that we actually of building our own so manufacturing facility in Buffalo headquarter, which will be up and running and be able to support the face one program.
In the <unk>.
Probably in queue for this year.
So we have.
Current GMP out of Baylor to support the.
The additional patient on Woolman, which will continue to happen and then we'll have a backup facility and the Buffalo headquarter that will come on line in a few months.
Thank you. Our next question on mine comes from Kevin <unk> from Oppenheimer. Please go ahead.
Hey, great. Thanks for taking my questions. Yeah, one of follow up on the car as well you know really interesting transaction uhm, if I understand the the Judy to program at this point the scent autologous.
You know contract just any general thoughts you have in terms of.
Continued investment and then I'll targus or should we think about.
For that program for neuroblastoma transitioning into your potential a generic.
Generic and any.
Timeframe, you can provide with regard to when we might see.
Some updated day now from anchor thanks.
A day.
Sure in terms of the autologous approach for the <unk> to study. This was embarked upon a couple of years ago and the goal at the time was to show that it's safe and efficacious to use and K T cells as a cell type for adoptive sell transfer.
So whether we are going to invest into an allergy Nick program in the future.
We haven't made that determination, yet, but suffice to say because of the and K T cell.
Low graft versus host the C step positions itself as of very ideal allergy unique approach I would believe I was saying that we're going to be invest additional resources into the allergy <unk> approach in the future going back to the Gd too for neuroblastoma, because it's a.
Section in terms of upfront payment, we're basically stock base source of transaction. So therefore, it didn't impact our our balance sheet.
And then the we are delighted to.
We see the confidence confidence in us going forward, the royalty or debt.
Beta is such a small percentage or a small percentage and the overall economics remain to be very attractive.
Thank you. Our next question on line comes from Chad Messer from Needham. Please go ahead.
Great. Thanks, Good morning sure.
Appreciate you getting on to my questions.
Could you just start with.
Iraq Zone.
Talked about this a bit but if I remember correctly one of the FDA concerns on one that surprised me.
Then it was a bit worried about what.
On a concern over adjudication of the data that there was somehow of bias.
Just wondering.
Pacifically if that's something you think you can address with this additional data that's something you can comment on on and.
As a follow up to that of you guys have of really extensive.
Clinical program going on not just with the rack solved with other oral chemotherapies.
Just wondering if there are any sort of lesson learned from this incident about whether it's the collaborating raider network of trial design or anything of existing or future planned studies.
That you think needs to change to sort of stay out of the way of this sensitivity.
The FDA or at least this division of the FDA appears to have.
Thank you Rudolf.
Ted Thank you for the question.
We feel strong the ETE the TT.
The ICL and analysis the question the FTA recounting the primary endpoint.
Problematic from the FDA perspective in the sense that the ICL is the industry scientific stent that for open label study. So we believe we have a very strong case and the argument and we intend to to get external validation of the position in <unk>.
<unk> back to the FDA.
Regarding to the other indications for the oral discovery platform.
<unk>, we are a lot more strategic and we certainly have.
Ah.
The pick our experience from the Rx on metastatic breast cancer going forward. So for the Angiosarcoma program. For example, we will be consulting with the FDA early on using the orphan drug status for the.
Hi Spy two program is the collaboration with Drexel and also of quantum leap, which would require.
Very well.
Which we leverage the.
And then if the external.
Input in.
In the U S on debt and the company's of Pembroke <unk> conducting very much in large.
Interest in the Mayo clinic, so we hope that those programs will will take those of lessons we have the into those programs I hope that answered your question Chad.
Check Johnson here just to add before the.
It's the organization we firmly believed at Ft is a very good government agency.
And then it's just like when they are providing feedback we should take as them seriously and learn from them as well. So in this context. So I think that they have we late questions did not with the.
So sort of saying that we are doing the right. What we have to do is to show as much data as possible to convince the.
The government agency of very fair government agency debt, we have been doing it correctly.
With regard to your question, whether we have learned something from FDA on dislocation that will be able to avoid certain sensitivities going forward. The way that we look at it you said, we are always learning and then from for FDA to be able to share with you as their concern and for what is the guidance with regard to directions.
We're picking them very seriously in the all for planning for all our programs going forward to ensure debt whatever data we per watt is up to the highest end debt as requested by FDA. So either way we are.
Working very closely with FDA and we intent to work for FDA to reserve when we solve all of the data the concerns as well as the differences in the opinions. So the going forward, we'll be able to enjoy a more smoothed path going forward.
Thank you.
And thank you. Our next question on line comes from Matt Kaplan Ladenburg Thalmann. Please go ahead.
Alright, good morning, and thanks for taking the question.
I just wanted to focus on the cure of therapeutics.
The acquisition.
Alright interesting transaction I guess more from the point of view of the safety and Tolerability of the car NTT and K T.
That form can you talk a little bit about the conditioning regimen, that's currently being utilized.
For for these patients and what are your thoughts I guess.
The kind of going forward and potentially the pre conditioning regimen.
Thank you Dan.
Sure. Thank you Matt for the question.
For the length of depletion pre conditioning regimen, it's the standard.
That is being used for the current cell therapy.
Yield, which includes cyclophosphamide cyclophosphamide and Fludarabine.
In terms of the safety and Tolerability.
Then we have seen so far we saw one grade two crs in the Q2.
The study, which is the neuroblastoma study.
Out of 11 patients. So obviously small numbers, but that's about 10% and I think that compares very well against the current first generation car T programs, which have a higher Crs rates. In addition to that in the.
The anchor study.
From old to patients so far and.
Reminding you that that's the allogeneic program and we currently have not seen any graft versus host.
Crs or neurotoxicity, so safety, so far appears to be pretty good and well tolerated and I think you asked an additional question.
Other we can.
Ameliorate or reduce the burden of LIFO depletion. That's certainly the question that we would like to explore at some point later in time, but currently we don't want to confound the phases with phase one of the side with too many questions that may make it very hard to interpret the data.
To be fair to Matt.
With the.
Our background and the effect will be my background was also on immunology I will be delighted to share debt based on our review of the data and the biology of NK and T cells.
We'll be planning to explore the option of reducing the ERP conditioning and days of possibility that we are going to be able to sort of circumstances to eliminate the majority of GP commissioning and debt is one of the of checkpoints of the program.
Which gets us very excited and just wanted to share with you of what we are currently thinking.
Net.
And thank you. Our final question comes from whom of robot from Evercore ISI. Please go ahead.
Thanks, a lot further follow up question.
One.
To clarify that the addition of data collection for the.
The tax of program does not include additional data from the other U S trials that youre running for.
The cure.
The acquisition could.
Could you maybe share some thoughts on the durability of the.
Generic.
19 program.
And is there any.
Technical barrier for re dosing. Thank you.
Thank you for the first part of the question with US do you want to address whether the additional data like angiosarcoma data that you are going to incorporate in our response.
The current planning.
Obviously collecting data as we speak in all of the studies, including safety data from all of the other studies and efficacy data on the angiosarcoma. Nevertheless, the meeting with the FDA focused on the complete response letter and we will definitely respond with additional data.
The asked the question, but right now the focus is on the complete response letter.
With regard to your second question on the allogeneic.
The approach of the data debt.
Sure Hi, Bill.
So for the anchor study.
The we had two patients enrolled and we have two responses the <unk>.
First patients with the PR. His duration of response was about three months and then the second patient with the CR. His response, so far it's about six months and I think you had another question related to the anchor city of which I forgot can you repeat that please.
Area for re dosing.
For the Allo generic Oh.
Yes, no that's a great question because.
The allogeneic approach, we dosing becomes more of a reality.
Which is certainly a limitation for the first generation car T.
Re dosing.
<unk> been done in the past.
On the autologous <unk> two study.
In fact, I think there are two patients that received <unk> dosing in the agenda to neuroblastoma study.
And we are planning to do the same thing with the re dosing or testing the hypothesis of the ability to re dosing patients in the anchor study.
And.
We are now going through our.
<unk>.
We want to gather more single dose data first.
So far we won't have to patients. So once we gather more single dose data will explore and maybe potentially.
The amend the trial so that we can that allow for dosing. So one idea could be for a patient to have stable disease can return debt SD into a PR with the re dosing. So these are all things that are on the drawing plans.
Hopefully, we'll be able to report more details once we have made the decision to.
Two extra of the bulk is that both from a scientific perspective the.
Feasibility and technicality.
And also the market potential.
Is it re dosing is certainly something days well within the scope of what we can do I hope that we addressed your question.
And thank you we have no further questions at this time I would like to turn the call over to Johnson Lau for closing comments.
Thank you all for joining US today, we continue to work for.
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