Q1 2022 Athenex Inc Earnings Call
[music].
Good day, ladies and gentlemen, and welcome to the first quarter 2022 our Phoenix earnings Conference call.
After the presentation, there will be an opportunity to ask questions.
To join the question queue you May Press Star then one on your telephone keypad.
Should you need assistance during the conference call you may signal, an operator by pressing star and zero.
And as a reminder, this conference is being recorded.
I would now like to hand, the conference over to Kelly Dougherty.
The Investor Relations you may begin.
Good morning, and thank you for joining our conference call today, we will provide an update on our Phoenix those business as well as a review of financial results for the first quarter of 2022.
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 website.
During 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 2022 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 you can find our SEC filings in the Edgar database at Www Dot FCC dot Gov or in the industrial relations.
Section at our website at Www Dot a Phoenix Dot com.
Speaking on the call. This morning will be Dr. Johnson Lau, Chief Executive Officer, Dr. Dan Lang President of Athene Excel therapy, Mr. Jeff Gordon Chief operating Officer, and Mr. Joe and Tony <unk>, Chief Financial Officer. In addition to the management team Dr. Curt Gunter Chief Medical Officer for cell therapy will also be avail.
Well to answer questions. After the prepared remarks, I will now turn the call over to Johnson for introductory comments.
Thank you Katie and thank you everyone joining our call to this call. This morning.
Eight weeks ago, well now you're in coal, we announced our strategic pivot to a focus set up could it be better at Phoenix.
Differentiated NK T cell therapy platform with first in class potential.
I'm pleased by our team's rapid progress and execution towards building the foundation for what we envision to be an industry leading franchise.
Promising early clinical data demonstrating the potential for our NK T cell therapy platform to be highly competitive.
Disruptive to both the current and emerging cell therapy landscape.
There is significant potential long term value of our <unk> ownership puffball compels us to make this a phoenix pop parkey.
And all clinical team yourself answering both allogeneic and autologous treatments for solid and Hematological malignancies.
Our two lead programs.
Cool fossil one and cool fossil two are progressing well in phase one dose escalation studies.
You won't hear much more about this.
Sorry.
On a corporate level, we continue to work to strength, our balance sheet and streamlined our organization by repaying debt with proceeds from monetizing non core assets.
Our global footprint.
We're implementing several cost saving initiatives.
As an example last quarter, we raised $40 million from the sale of our Dunkirk facility.
We deployed towards debt repayment and reinvestment in our cell therapy platform.
But we are not done.
It's part of our strategy, we built several hardy attractive assets and rapidly growing businesses that can help you monetize to extract maximum shareholder value.
We have a significant progress and will make an announcement at the appropriate point.
We still pocketing, a 50% reduction in operating expenses and expect to see the impact of our actions, resulting in tangible cost savings throughout the year as we reduced headcount and wind down non core operations.
I'm also pleased to report that we have continued to grow our E. P D and E. T. S divisions full expanded partnership agreements with EMCORE.
Global Biopharmaceutical company.
Janus and emerging generic pharmaceutical company.
Mr. Jeff Yogurt, we will pull whiteboard details later.
In fact, the Apd and Aps business has been gaining so much momentum.
Demonstrated in the first quarter.
We are now raising our pocket so sky this from 15% to 10% in 'twenty to 'twenty two to 22, 5%.
We previously reported on our business decision to discontinue further investment in our own coffee platform.
However, there's still two ongoing oral paclitaxel trials, they could bring potential value.
Requiring limited incremental investment.
We continue to follow their progress.
I would highlight these things too I spy two trial, which is expected to read out in the second half of 'twenty to 'twenty two.
This study is being conducted by the quantum leap health care collaboration using oral paclitaxel in combination with dose sorry about plus or minus cobbled packet in breast cancer patients you did new adjuvant setting.
Meanwhile, we also had ongoing regulatory interactions with image I E.
Switching responses to questions. We received regarding use of oral paclitaxel in metastatic breast cancer in the United Kingdom.
Well look for opportunities to advance this program for potential partnerships or other means.
Lastly, our first approved a proprietary product considerably for the treatment of actinic keratosis continues to perform well in 2022.
Yesterday, our partner Admiral reported that they are making steady gains are chipping a three 6% market share in a hardening generic market and recording over 32000 prescriptions generated since launch.
They have also made progress on it.
Increasing the commercial coverage to over 60%.
And Medicare coverage was granted it has already increased to over 33% coverage.
The guidelines for the management of Actinic Keratosis were recently published in the journal of the American Academy of Dermatology.
And cause serious receptor E. These guidelines committees strongest recommendation.
I'm extremely proud of our team's focus is executing on our strategic pivot and I'm highly optimistic about Phoenix ability to transform into a lean and focus. It just says that is competitively positioned in a growing immuno oncology sector.
With that I will turn the call over to Dr. Tang leg to discuss our increased T cell platform.
Please go ahead.
Thank you Jonathan and good morning, everyone.
This quarter, we continued to build upon our foundational cell therapy platform.
Politically advancing our lead candidates toward the goal of creating a differentiated franchise with a particular focus in the allogeneic NK T cell treatments.
Recently, the American Society for transplantation, and cellular therapy featured our cooler five Oh tier program in their online magazine nucleus.
The potential for allogeneic car NK T cells could be the goldilocks cellular therapies offering, but that's a T cells in terms of manufacturing and cryopreservation and the best of NK cells in terms of no risk of graft versus host disease.
As the Goldilocks I'll cellular therapies and get T cells are the ideal cell types.
I don't think that that's a both innate and adaptive immunity to achieve a highly effective off the shelf treatment that is lower and toxicity and more accessible to a broader patient population.
Ultimately NK T cells offer significant therapeutic potential.
Major challenges are a proof.
Car T therapies and other cell therapies in development.
For our phase one anchor study a purified go too.
Our allogeneic car NK T treatment targeting relapsed refractory lymphoma leukemia, we recently presented an interim phase one dose escalation data update at a S. T C T.
The data demonstrated strong efficacy and excellent tolerability in heavily pretreated patients at early low dose escalation levels.
We have so far provided response data from seven evaluable patients with five patients in the lymphoma cohort.
Update includes two additional patients one with non Hodgkin lymphoma, the other with acute lymphoblastic leukemia.
In the lymphoma cohort data show to see ours at one P. R.
60% overall response rate, including two responses in patients who have failed previous autologous car T therapy.
A six month complete response rate of 40% was reported.
Clothing, one ongoing complete responses at 34 weeks.
Importantly, we're seeing these results at the low doses of $10 million and 30 million cells per meter square.
The safety profile was favorable.
No infusion related reactions, no graft versus host disease.
I can't and.
And three cases of mild grade one cytokine release syndrome or Crs.
Importantly, data demonstrating car NK T cells homing.
Going to the tumors and expanding in peripheral blood are encouraging.
Or potential for Marvell bust and durable response as we dose escalate.
Clinical data from our pure fiber one program and relapsed refractory high risk neuroblastoma will be discussed in an oral presentation at the upcoming a S. G. C. T conference in Washington D. C on may 16th.
We will report an interim update demonstrating responses in NK T cell expansion in trial in pediatric patients infused at four dose levels explored in a phase one dose escalation study generic it too.
The abstract issue last week reports on overall response rate of 25% or three out of 12 with sponsors.
Two out of three responses were seen at dose level, four or 100 million cells per meter square, suggesting a dose response and we observed a durable complete response persistence for 12 months.
Data also support a highly encouraging safety profile with no dose limiting toxicities or grade three or higher side effects related to car NK cheese.
So far there was only one case of grade two Crs that was easily managed.
Purified World one car NK T cells expanded in all patients peak in two to four weeks post infusion.
Collectively these data will provide supporting evidence that our autologous car NK T cells directed against <unk> are safe.
Can expand post transfer home to German sites and produce objective responses in high risk neuroblastoma patients.
Importantly, the analysis found that responses correlated with car NK T area under the curve in the blood as well as a percentage of <unk> 16 to a positive expression, which are markers for NK T cells that have central memory or stem like attributes such as longer part.
Systems.
I hope it is clear to you as it is to us that the emerging data are supportive of the key differences between NK T cells and other cell types being explored for oncology therapies.
Additionally, as an evolving world leader in NK T cell therapies.
Excited that our pipeline has first in class potential offering the promise of meaningful therapeutic benefits to indications with significant unmet need.
Our NK and T cell therapy platform has also demonstrated a unique ability of NK T cells to expand after dosing with persistence and blood.
Timber and tissue a key characteristic that separate NK T cells from other cell types, such as NK cells.
The potent anti tumor activity of our car NK T cells is occurring at doses orders of magnitude lower than the doses needed to achieve clinical efficacy with car NK cell therapies.
Coupled with a favorable safety profile, we believe that's why therapeutic window of car NK T cells will enable us to dose escalate and repeat dose to drive deeper and more durable responses.
Lastly.
Inherent NK T stop properties paid represents a key advantage in the treatment of solid tumors.
Including their natural tropism to home towards tissue in tumors.
And a differentiated ability to kill terms tumor associated macrophages, and Mds see myeloid derived suppressor cells that suppress endogenous anti tumor immune responses that lead to cold tumor in microenvironment.
And K T cell, killing of chance in Mds.
Through interactions with CD, one b has the potential to help turn a cold tumor into an inflamed immunogenic tumor.
Looking ahead to the remainder of the year, our digital abstract accepted by Azgul for care of $5 three our allogeneic G. P. C. III car NK T treatment for liver cancer.
The highlights preclinical data on a new.
New transcription factor supporting our clinical development of a car NK T cell treatment for liver cancer.
We plan to file an NDA for <unk> in 2023 for our bonds had paddock cellular carcinoma.
We are executing on expanding CD 19 car NK T anchor study into a multi center multi center study to establish a recommended phase II dosing.
Well, that's exploring a multi dose regimen.
We are also looking forward to additional updates later this year for cure a cycle too.
She didn't get too is currently enrolling patients at dose level five.
We're hoping to make a go no go decision about pivotal study and to meet with the FDA regulatory path in early 2023 for the indication of high risk pediatric neuroblastoma.
Collectively our NK T platform continues to support the idea that NK T cells are the goldilocks of cell therapy.
The best of both innate and adaptive immunity and demonstrating excellent safety promising efficacy and robust tissue and tumor persistence following treatments.
We remain highly encouraged by the promise of our NK T cell platform.
I will now turn the call over to Jeff to discuss operations.
Yes.
Thank you Dan and good morning, everyone.
Before getting into the strong quarterly results I'd.
I'd like to provide some broad comments regarding the positioning of the franchise for those less familiar with this business segment.
Over the past five years, the Phoenix a P D.
P. S has grown this business revenues by leveraging managements capabilities.
Industry experience and long standing relationships that continue to bring new opportunities to the pipeline that adds scale and expand margins.
As an example of those relationships we.
We are excited to announce that the Phoenix and MTR.
Through their U S injectable company Avnet.
Have agreed to a comprehensive collaboration in the United States.
The Phoenix will market certain other products in the U S.
And the first product was agreed upon recently.
Avid has an extensive portfolio of approved and pipeline products, which will be manufactured in a new FDA inspected facility in India.
The first products should launch no later than Q4 of this year.
The recent strategic decision to sell our manufacturing facility in Dunkirk has contributed to a significant reduction in overhead which will continue to improve operating margins.
I am also pleased to report that the state of New York has just allowed immunity bio.
Our new <unk> contract manufacturer to utilize the fenix five Oaks III B license for Dunkirk without requiring a six month registration process.
We can now begin to file for the licenses for other states, which is estimated to take between four to 12 months.
From our vantage point the business has added important and promising inflection point.
And this first quarter's update exemplifies the opportunity ahead.
Now for the quarter.
For our E. P S. In a P D businesses sales for the first quarter 2022.
Or $29 million up 42% year over year, compared with $20 4 million for the first quarter in 2021.
We attribute the strong performance in the first quarter to three drivers.
The first being resolution of prior supply chain issues that had been impacting our ability to access API.
Additionally, one of the four new launches is an injectable product that is currently on the FCA at American Society of Health system pharmacists shortage list.
And we were able to take advantage of favorable pricing dynamics, when we stepped in to supply the market.
Our partner has already manufactured additional inventory.
We will be well supplied to sell that product.
Lastly revenue from our Covid products, Inc.
Increased significantly.
As a result of the spike in Covid cases during the first quarter.
In addition to the four products launched in Q1.
And we have an additional eight planned for 2022.
Two of the planned new introductions Pemetrexed and Bortezomib R.
A very significant products with tentative approvals.
Will be launched at market formation this months.
This time, he should allow them to capture significant market share.
The sales of Pemetrexed and participant.
I expect them to contribute to increased revenues and margins of the overall business significantly.
Our Phoenix pharmaceutical division.
Currently markets 29 products.
With 54 Skus.
And the Phoenix pharma solution markets six products and.
And 16 Skus.
We launched <unk> gamma Dax pre filled syringes at Aps and <unk>.
Q1.
And added three new private label codes for Paclitaxel.
The result of the recent progress is that our business is now stronger than ever.
With these new products, leading to an enhanced product mix with improved margins.
We have visibility into persistence and robust growth.
And our overall company margins continue to improve.
Further product launches by Aps.
And the recent receipt of licenses to ship 500, <unk> products are expected to result in stronger 2022 sales.
Significantly increased growth in 2023.
I will now turn the call over to Joe <unk> to discuss the financials.
Thank you Jeff good morning.
Everyone on our fourth quarter 2021 call I indicated that we are in a season of breaking down and building up.
Along with that I outlined two overarching strategies that we have undertaken to strengthen our balance sheet.
Pivot the business towards our cell therapy platform.
First the divestiture of noncore assets and second the cost reduction opportunities.
We continue executing on both fronts as exemplified by the Dunkirk sale into first quarter and we anticipate announcing more result soon on each of these threats, which we can use to extend our cash runway for at least 18 months.
Before discussing our standard financial results, let me first highlight a figure that you could think of as a proxy for evaluating cash burn.
This figure is our cash flows from operating activities and continuing operations and excludes results from the Dunkirk itself.
For the first quarter of 2022 the cash use was $18 $5 million. This compares to the cash used in the first quarter of 2021 of $29 $7 million and the cash used in the fourth quarter of 2021 of $35.8 million.
So from the fourth quarter 2021 to the first quarter 'twenty 'twenty. Two this represents a quarter over quarter decrease of 48%.
Now, let's discuss the first quarter financials.
I would ask that you. Please refer to our press release that was issued earlier today for a full summary of our results, but I will highlight the following.
Total revenues for the first quarter, 2022, or $29 $7 million compared to $41 million for the same period in 2021.
Which included a $20 million milestone payment from all Merle.
Excluding the one time payment product sales revenue increased by $8.6 million or 42% over first quarter 'twenty one.
R&D expense totaled $14 million for the first quarter, a decrease of $9 $1 million or a 39% year over year decrease attributed primarily to a reduction in oral paclitaxel development costs.
SG&A expenses totaled $14 9 million for the first quarter and this represents a year over year decrease of $5 8 million or 28%, which was primarily related to decreased oral paclitaxel commercialization expenses.
That loss is attributable to our Phoenix for the first quarter, 2022, or $17.4 million or 16 cents per diluted share versus $25 $1 million or 27 cents per diluted share in the first quarter of 2021.
As of March 31, 2022, where we had debt of $125 million under our senior credit agreement with Oaktree, which we'll continue to repay with the proceeds from our asset monetization activities.
As of March 31, 2022, I think Nick's had cash cash equivalents and restricted cash of $51.2 million.
Finally, we are raising our guidance on our specialty pharma business to a growth of 20% to 25% from the previous 15% to 20% growth.
The strong performance of this unit in the first quarter the earlier than expected near state license and the attractive pipeline of expected launches have contributed to this decision.
I'll now turn the call back to Johnson for closing remarks.
Thank you Joe.
And thank you everyone for joining us today.
Our focus for 2022 continues to be on transforming <unk> into a streamlined pure play so far if you're a company with a solid balance sheet to provide good runway to continue to deliver exciting data.
We are proud of the progress we have mixed since we announced our strategic pivot and remain committed to delivering on those plans with additional monetization of non core assets and cutting of operating expenses.
We believe that our cell therapy programs will be the main two hypo all future growth and position us to be a leader in this space.
These initiatives continue to set us up for a successful value creation and allow us to further execute on our ultimate mission.
Even though we did treatments to cancer patients.
I will now open the call for questions.
Operator.
Thank you we will now begin the question answer session.
And you May Press Star then one on your telephone keypad.
You'll hear a tone acknowledging your request.
Youre using a speakerphone please pick up your handset before pressing any piece.
Try your question. Please press Star then.
Q.
Well pause for a moment as callers join the queue.
The first question comes from Jon Miller with Evercore.
Please go ahead.
Hi, This is Jessica on for John Miller, and do you have any more clarity on what the bar for our current fiber line and as a go or no go. This year you spoken about a rapid possible path to approval for this program do you have any more clarity on what would be required.
Required thank you.
Dan.
Sure if I could just one other question.
As you know the you know Judy to antibodies. They generally have a response rate of about 30%.
And they're a pathway for approval is through a single arm.
Pivotal study of about 70 to about 100 patients because this is a pediatric orphan indication, but very terrible prognosis.
We believe by similar bar.
Something you know with a 30 plus percent response rate that's durable.
A regulatory pathway, we are hoping it will be similar to the June two antibody a single arm.
Pivotal study with about 70 to 100 patients might.
Might get stabbed a approval obviously F D a.
The final.
The decision maker on the regulatory pathway. That's why we are looking forward to.
I have discussed with the FDA in terms of our pathway in terms of a bar on go no go decision.
Since we already saw two out of three responses that dose level, four which is 100 million cells per meter square, if we maintain that kind of a response rate at higher doses I think that will give us confidence and conviction that.
This well.
<unk> be successful in a pivotal study and benefit patients in the long run.
Thank you.
Yeah.
The next question comes from Kevin <unk> with Oppenheimer.
Please go ahead hey.
Thanks for taking our questions.
Dan at five O. Three can you can you just walk us through what the rate limiting steps to T V. I N D. R and perhaps you know what if it's not too early some color as to whether we should think about that as being a potential first half 'twenty three or more likely the second half of 'twenty three.
Yeah, So Kevin and thanks for the question so the.
Digital abstract there'll be submitted we'll describe they do transcription factors.
After three P. A T F to be that we're going to incorporate into the final III construct.
This transcription factor makes the NK T cells very potent and also they persist.
Longer as a result of this discovery.
We actually file our patents around it and once that's done.
We're now currently doing deep the IND, enabling studies.
The I N D. Currently we're guiding to 2023.
As the year progresses, we'll have more precision as to whether it's gonna be excuse me first half or second half.
You know provide update when we have a better color in terms of the specific timing.
And your second follow up question relates to sorry remind me.
So actually you can draw.
Jumping out of me here, but I guess a follow up question really is on a S. T. A C T and just sort of a reminder of.
You know sort of when the cutoff for abstract submission it was sort of some perspective as to the scope of our additions.
Additional data that might be available in the presentation next week.
Yeah, Yeah. So all the data is in the abstract will have data on 12 patients.
Again three responses.
Two of the three responses were in deal for one PR and once you are the last for over a year.
We don't expect to have additional data by the time of S. GCT, which is only a couple of weeks congratulate him next week may 16th So that's all the data we have.
Kevin.
Great and if I can ask you just slip in one more.
And then maybe for Johnson <unk> Johnson.
If theres a positive feedback from MH alright.
Kind of kind of what happens after that you know strategically I mean, it's.
Yeah It was it.
Do you do then you take that feedback and you know potential path to market in.
Good of regional partners I mean, I'm, just trying to kind of appreciated in the absence of a clear pathway for larger markets how to think about the strategic value of that feedback.
Right, Kevin we in general as you know do not comment on our regulatory communications, but suffice to say, let me emphasize two ut procedure in Wolf with regard to discussion with <unk>.
Directly to authorities like the UK Army Charlie.
We announced that we filed two MH out a I think in fourth quarter like November last year, and then usually after some period of time till provided feedback and then do.
Do you feel that you should will consists of a number of questions and then we'll tend to have communications with them and.
And we'll take questions and requests Luton.
So Ah Mendy application and answer questions and we meet for them to evaluate gang.
We are in active and constructive discussion with Amazon right now and certainly we would not be able to comment to you we have a more definitive timeline with the.
The discussion and I hope you got them.
<unk> regulatory discussions engine general one should not comment on out it could discussion would be image Howie.
Thanks for taking my questions.
Thank you.
The next question comes from Robyn, Karnataka with Truest Securities.
Please go ahead.
Hi, guys. Thanks for taking my question.
Just starting with the fact that you can you just walk me through like what what are your plans for them.
How how you really when it goes up and then as Youre seeing a lot of the players in this space are really thinking about trying to do therapy that gets around Lindsay depletion do you think with NK T cells that's possible.
Yes.
Thank you Robyn.
So currently we're at the second dose level of at 30 million cells per meter square and you know we're already seeing very robust response rate that compares very favorably against the approved car Ts.
Because these cells are very potent we end up.
Have a very favorable safety profile and again, that's why we believe that we have to watch our imputed window that allows us to dose escalate and drive.
A deeper and more durable responses so it's.
We're going to follow the data.
Next level at dose level, three would be 100 million cells per meter square so.
So we'll decide I will follow the data and that data inform us as to what's the best dose going forward. The other thing I'd like to mention is that.
Because these are allogeneic cells, we have the benefit of pulling the lever on repeat dosing.
Which you can and you saw from other competitors in the space that are.
They are able to drive deeper on durable response with repeat dosing, so something like giving two or three doses. After the first Audi is potentially something that we would like to explore.
So the second question relates to a L D.
Can you repeat that again, please robin yeah, I mean, you're sort of going along the lines for repeat dosing, which is where the field was going a lot of people are talking about how you ultimately don't want to have went through depletion or you want to reduce the burden for depletion.
Thinking about.
You know, what's the strategy if you're gonna do repeat dosing how quickly can you get in front of the FDA to request that cause that takes time and then.
And for Lindsay depletion what are your thoughts in higher Ed.
Exploring alternatives to flu side, if you're going to go for that approach.
Yeah, Great question Robin.
Because the intrinsic biology of Banca T cells, we believe part of the mechanism of action is for the NK T cells to activate and propagate the host immune response.
If you know when we do more quantitative studies and when we see that as a very important contributing factor for the you know how we can anchor T cell, killing tumors, we will consider and we actually have five recommendations from a S. B that we may want to take away. The Fludarabine. As you know is very toxic to T cells and then.
We believe that.
The host immune response is actually paying very integral parts and killing the tumor you know we may want to explore the idea of taking away that food Arab you know just having a cyclophosphamide for L. D that would really differentiate us from other competitors in that space. The only are they using L. D. There using enhanced or in.
Intensive al do you are they adding an additional chemotherapy to really wipe out the host immune response.
So we have an interest and desire to simplify the regimen L. D. If the data supports that and also this really make this therapy are very.
Easily tolerate it.
Hopefully, we can expand access to the community hospitals because this is in the outpatient a 10 minute infusion therapy, and we will have a simplified L. D regimen, they will make it even more competitive.
Okay great.
The next question comes from Jonathan Chang with SBB Securities.
Please go ahead.
Hi, good morning, Thanks for taking my questions.
First question on care five O one.
The autologous car NK T program, what are your longer term plans for this.
It's a focus for the platform on the allogeneic efforts or are the autologous efforts also part of your long term plans.
Yeah.
Dan. Thank you Jonathan for the question because this was a first in human.
Study 10.
Testing NK T cells as a cell therapy for cancer, we started out.
Taking baby steps.
Testing the NK T cells in the autologous setting once we know that it's safe and efficacious then we'd take more took more risk and study NK T cells and in the allogeneic setting for five O two going back to the 501, because this is a pediatric you know orphan indication they're only up.
About 1500 cases, a year and we're seeing robust responses in autologous setting. We believe that this will be a competitive product by itself in the pediatric neuroblastoma landscape.
That's all autologous cell therapy.
Treatment for these patients that really have no alternatives.
Longer term.
You know as a potential label expansion strategy.
Gee, they too you know.
Car NK teach proves to be.
Vacation and say, we can consider putting into G. D. Two car onto the NK T cell platform as an allogeneic approach from donors.
Because there are other cancers to also express Judy too for example in small cell lung cancer.
Just curious you know relatively a large market compared to the pediatric neuroblastoma market.
We can put that you'd be to answer car NK T and.
Produce allogeneic approach because you know small cell lung cancer, it's really hard to treat solid tumor.
So far the approved car Ts or other car Ts have had mixed results in.
Generally they are meaningful efficacy because so you know a lot of the autologous approach cannot we cannot give more than one dose, but with the allogeneic approach, where you can pull a lever on giving multiple doses.
That's gonna be potentially.
Potentially important in generating meaningful efficacy for a solid tumor life small cell lung cancer, but that's you know down a row and we yeah, we would be.
Prioritizing getting the autologous firewall one approved first about pediatric neuroblastoma, and then explore taking the gd to into allogeneic setting I hope that answers the question Jonathan.
Yeah. That's helpful. Thank you.
Second question what are the other noncore assets that you could monetize to support the cell therapy pipeline and beyond monetization of these noncore assets and and cost cutting.
Are there other avenues being considered to extend your cash runway.
Right now remember that when we build.
This is to support the launch of oral Paclitaxel.
<unk> deep beauty API do supply chain and also from a supply chain, especially to a farmer.
And also we have other assets with regard to the product.
The market, including the series D or so being developed together to support the growth of Phoenix right now the focus of the company is to focus on cell therapy, and therefore, the non cell therapy related asset can obi.
Consider as non core assets and we are in the process of addressing all these to other non coal area south of our S. S and Symphony I mean, our our approach is to try to be.
<unk>.
So so far I've tried to be non dilutive for the shareholders at the same time to reduce that debt and and cutting costs and by doing it. This way, we will be able to extend the cash runway and to allocate resources to support the main focus of the company and Thats what were doing right now.
Yeah.
Got it thanks for taking my questions.
Thank you.
Once again, if you have a question. Please press Star then one.
The next question comes from Yale Jen with Laidlaw and co.
Please go ahead.
Good morning, and thanks for taking the questions.
In terms of Kurt five O to O. What should we anticipate for the update and future update at ash regarding potentially the size of the patients.
And any other aspects.
<unk>.
Sure Yeah. So just to level set the current five O. Two study is a single center study conducted.
Conducted at Baylor College of Medicine.
We got out of India approved a company sponsored R&D improve back in March and we're working currently very hard to stand up.
Other sites to expand and accelerate clinical enrollment, we're not providing guidance as to how many patients we're going to have by year end, but you know.
Be assured that this is out in a high priority to enroll more patients from different centers to hopefully replicate the very promising data that we have shared with all of them so far.
Okay. That's helpful and maybe two quick ones. The first one is the in terms of the close Sarah giving the the growth of it in terms of the growth in the market penetration.
Do we anticipate any revenue a tour or Athena.
The Phoenix later this year and maybe one more quick follow up.
Hopefully this.
Yes, we do.
Start receiving royalty after the initial sales from Opana Ambarella every quarter.
And then the indicate already because sui product is penetrating into a market, where you can really well and according and it's a little bit exceeding all expectations. So right now the product is already endorsed by the AAP.
Highest recommendation for actinic keratosis and he's also covered by Medicare part D as well.
Okay last one is it's similar to the earlier question, which is that the if the spy too I spy two outcome is positive.
What could be the next step in terms of the leveraged C&I inflammation and thanks.
Thank you for this question I think the obviously the eisai to <unk>.
So very positive.
Oh the wheel.
Right.
And the good part you set out for the I spy two I swell.
Other studies going on in.
In conjunction anti PD, one day, they do not require significant capital input from our Phoenix at this point, which is very good for us auto seat there will be a push.
This potential value to be unlocked from I spy two is positive and obviously, we would like to see data before deciding on the next steps what we can commit to you said, we will not invest in a big way on the phase III trial to get this on our own done on our own. We are we will certainly be working closely with our partners.
In both the anti PD one collaboration.
For the non small cell lung cancer as far as I spy two to look for opportunities to unlock value and this can include partnerships or collaboration and ultra C. We could explore other ways to realize the value of fortis asset for our shareholders.
Okay, great. Thanks, a lot I appreciate it and to the best of luck.
Thank you. Thank you yeah.
This concludes our question and answer session and would like to turn the conference back over to Dr. Johnson Lau for any closing remarks.
Thank you everyone for joining us today and this is a conclude our call today. Thank you.
Ladies and gentlemen, this concludes today's presentation.
Thank you once again for your participation you may now disconnect.
Yeah.
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