Q3 2022 Fate Therapeutics Inc Earnings Call
The conference will begin shortly to raise your hand during Q&A you can dial star one one.
[music].
Uh huh.
Welcome to welcome to the fate Therapeutics third quarter 2022 financial results Conference call.
At this time, all participants are in listen only mode.
Call is being webcast live on the investors section of states' website at fate Therapeutics Dot Com as a reminder, today's call is being recorded.
I would now like to introduce Scott Walsh co President and CEO of fate Therapeutics.
Thank you good afternoon, and thanks, everyone for joining us for the fate Therapeutics third quarter 2022 financial results call. Shortly after four P. M. Eastern time today, we issued a press release with these results, which can be found on the investors section of our website under press releases.
In addition, our Form 10-Q for the third quarter ended September 32022 was filed shortly thereafter and can be found on the investors section of our website under financial information.
Before we begin I would like to remind everyone that except for statements of historical facts. The statements made by management and responses to questions. On this conference call are forward looking statements under the Safe Harbor provisions of the private Securities Litigation Reform Act of 90 to 95.
These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward looking statements. Please see the forward looking statement disclaimer on the company's earnings press release issued after the close of market today as.
As well as the risk factors included in our Form 10-Q for the quarter ended September 32022 that was filed with the SEC today.
Undue reliance should not be placed on forward looking statements, which speak only as of the date. They are made as the facts and circumstances underlying these forward looking statements may change.
Except as required by law.
<unk> therapeutics disclaims any obligation to update these forward looking statements to reflect future information events or circumstances.
Joining me on today's call are Dr. Wayne Chu, our Chief Medical Officer.
<unk>, our Chief Financial Officer, and Dr. Bob <unk>, our Chief Research and development Officer.
We will focus today's discussion on upcoming clinical and preclinical data presentations for our off the shelf Ips derived car NK and T cell programs for the treatment of cancer and.
And how we expect our first inclined pipeline to advance and evolve in the coming months, including through our collaboration with Janssen and Ona.
At the society for immunotherapy of cancer annual meeting being held next week in Boston, We will present clinical and preclinical data for Ft, 536, which is our first car NK cell program for the treatment of solid tumors to reach clinical.
<unk>.
The multiplexed engineered product candidate incorporates four functional elements, including a car targeting the alpha three domain of the Mickey Mickey proteins high.
High expression of <unk> proteins, which is induced by cellular stress damage or transformation has been reported on many solid tumors.
And while the Alpha one and alpha two domains of MC game fee are prone to protolithic shut in and can lead to tumor escape.
Alpha three domain in particular is resistant and provides a promising targeting strategy for re engaging tumor cells.
Ft 536 also incorporates our proprietary high affinity non cleavable <unk> FC receptor to enhanced antibody dependent cellular cytotechs cytotoxicity.
And enable multi antigen targeting in combination with monoclonal antibody therapy.
We believe the novel multi antigen targeting strategy of Ft, 536 can drive significantly improved outcomes for patients with solid tumors.
The phase one study of FTE 536 is designed to assess the safety and activity of a three dose treatment schedule as mono therapy.
And in combination with monoclonal antibody.
At <unk>, we plan to report clinical data.
The first three patients treated with <unk> hundred six as monotherapy in the first dose escalation cohort at 100 million cells per dose.
This study is currently enrolling patients as monotherapy in the second dose escalation cohort at 300 million cells per dose.
In addition to leverage the mechanism of action of our high affinity non cleavable CD 16 receptor, which is incorporated into ft 536.
We have also initiated enrollment with the Egfr targeted monoclonal antibody cetuximab.
In the first dose escalation cohort at 100 million cells per dose.
As this study advances we intend to also investigate combinations with Trastuzumab <unk> and premarin lose a mab to promote multi antigen targeting of solid tumors.
At <unk>, we also plan to unveil and present preclinical data for three new multiplexed engineered Ips derived car T cell product candidates for solid tumors that are advancing toward IND, enabling studies.
Our first car T cell product candidate Ft 873.
<unk> targets the antigen <unk>, three which is an immuno regulatory protein over expressed in cancer.
Promotes tumor growth.
Tasked assist and drug resistance.
Newly disclosed product candidate incorporates three functional elements into the trac locus.
Our novel Camelid nano body car targeting <unk> three.
And IL seven receptor fusion protein.
And our CD 16 FC receptor.
Ft $8 73, as a wholly owned program.
The second car T cell product candidate FTE 862.
Is partnered with Janssen.
Targets <unk> and.
An antigen with prostate restricted expression that is maintained during prostate cancer progression.
Preclinical data generated under our collaboration with Janssen demonstrated that multiplexed engineered Ips derived car T cells targeting <unk> have the potential to effectively infiltrate tumor mass and.
Eliminate tumor cells, and a highly selective manner and to prolong survival in xenograft models of prostate cancer.
As a reminder, janssen funds all preclinical development of the FTA six two program and has the right to exercise an exclusive option to conduct worldwide clinical development and commercialization and we maintain the right to co commercialize and share equally in profits and losses.
FTE six two in the U S.
The third car T cell product candidate FTA two five.
Is partnered with Ono and targets, an undisclosed tumor associated antigen with a novel binding domain developed by Ono.
<unk> hundred 62 incorporates multiple innovative elements, including synthetic receptors designed to promote cell trafficking.
And prevent immunosuppression in the tumor microenvironment.
Preclinical data generated under our collaboration with Ono demonstrate its potential to overcome several unique challenges in treating solid tumors with cell based cancer Immunotherapies.
We have now initiated the generation of the Master cell bank for the multiplexed engineered Ips derived car T cell collaboration candidates.
In addition, we are positioned to achieve our specified preclinical milestone and initiate IND, enabling activities later this year for FTA two five.
Upon achievement of this specified preclinical milestone Ono has the right to exercise an exclusive option to conduct clinical development and commercialization and.
And we maintain the right to co develop and co commercialize FTA eight five in the U S and Europe .
We believe we have one of the most novel diverse and deep cell based cancer immunotherapy pipelines for solid tumors, which is a uniquely enabled by our proprietary Ips C product platform and in particular, our ability to multiplex engineered Ips CS with synthetic modalities.
<unk> to achieve target specificity overcome tumor heterogeneity promote cell trafficking and induce cell activation in response to repressive signaling in the microenvironment.
At the American Society of Hematology annual meeting and Exposition being held next month in New Orleans, We will present initial clinical data for FCA 19, our CD 19 targeted car T cell product candidate for B cell lymphoma.
And for Ft, 576, our <unk> targeted car NK cell product candidate for multiple myeloma.
As a reminder, FTA 19 incorporates a bio <unk> insertion of an anti CD 19 car transgene into the T cell receptor alpha constant Lucas with complete disruption of T cell receptor expression.
And its car construct is comprised of a novel <unk> co stimulatory domain that is designed to balance T cell activation and exhaustion.
To our knowledge FTA 19 is the first ever T cell product candidate manufactured from a clonal Ips C line to undergo clinical investigation.
The phase one study for B cell lymphoma is assessing both a single dose.
And a three dose treatment schedule and dose escalation is currently ongoing in the third single dose escalation cohort of 360 million cells and.
And in the second three dose escalation cohort of 60 million cells per dose.
At this early stage of dose escalation with the FTA 19 enrollment is primarily ongoing at U S. Academic medical centers, where we continue to see investigator enthusiasm for off the shelf Ips derived car T cell program.
While there are three FDA approved CD 19 targeted autologous car T cell therapies, there remains a significant unmet need for patients at these medical centers that are unfit for or have already received autologous car T cell therapy and require.
Effective treatment.
At Ash the initial clinical data presentation for FCA 19 will include nine patients in single dose escalation cohorts of 90 million cells and 180 million cells.
As well as three patients in the three dose escalation cohort of 30 million cells per dose.
Consistent with the high unmet need the majority of patients administered FTA 19 have aggressive disease and are heavily pretreated, having received at least four lines of prior therapy with approximately half of patients having received prior CD 19.
<unk> targeted autologous car T cell therapy.
At Ash, we will also present initial clinical data for FTE 576, or be CMA targeted car NK cell product candidate for multiple myeloma.
Despite the recent launch of two FDA approved the CMA targeted autologous car T cell therapies. We believe there is tremendous opportunity for <unk> hundred 76, as an off the shelf car NK cell therapy, with a differentiated product configuration and mechanism of action.
<unk> hundred 76 incorporates a novel <unk> binding domain that triggers target cell license at low levels of <unk> expression.
But multiplexed engineered product candidates also incorporates our proprietary high affinity non cleavable CD 16 receptor to promote antibody dependent cellular cytotoxicity.
And enable multi antigen targeting of myeloma cells in combination with Dara to Matt.
Importantly combination with Dara to Matt is enabled uniquely by knockout of CD 38.
Which eliminates the possibility of CD 38 mediated fracture side.
The phase one study for multiple myeloma is designed to assess single dose and multi dose treatment schedules as monotherapy and in combination with Dara tune them.
We are pleased to announce that the single dose escalation cohort at 300 million cells as mono therapy has cleared dose limiting toxicity.
We are now currently enrolled patients in two dose escalation cohorts at 300 million cells per dose as monotherapy.
And in combination with Dara to map.
And upon clearance of these cohorts, we plan to initiate enrollment in three dose cohorts at 300 million cells per dose, both as monotherapy and in combination with our tumor.
At Ash the initial clinical data presentation for Ft 576 will include approximately nine patients.
Six patients in the single dose escalation cohorts of 100 million cells.
The 300 million cells as monotherapy.
And three patients in the single dose escalation cohort of 100 million cells in combination with Dara.
At this early stage of dose escalation the majority of patients administered <unk> hundred 76 are triple class refractory, including refractory to last prior therapy.
Having received at least four prior lines of therapy.
As we seek to build a highly differentiated myeloma franchise, we're excited to unveil our development of Ft 555 under our collaboration with Janssen.
Ft 555 is a multiplexed engineered Ips derived car NK cell product candidate targeting <unk>.
An orphan G protein coupled receptor found to be highly expressed on myeloma cells.
Importantly, <unk> expression is independent of <unk> expression.
Suggesting that it is a target of unique therapeutic value for patients with relapsed refractory myeloma, regardless of treatment with prior P. CMA targeted therapy.
In May Janssen exercised its commercial option to ft, 505 for which we received a milestone payment of $10 million.
We are currently conducting IND, enabling activities with Janssen to support first in human clinical investigation in 2023 of Ft 555 <unk>.
Including in combination with Dara <unk> to simultaneously target <unk> and CD 38 antigens.
At Ash the companies will jointly present preclinical data of <unk> hundred 55, demonstrating its activity profile.
As a reminder, under the collaboration Janssen has the right to worldwide clinical development and commercialization and we maintain an opt in right to co commercialize and share equally in profits and losses in the U S.
At Ash, we will also highlight novel multiplex engineering strategies to eliminate the need for intense lymphoma conditioning chemotherapy.
Which is currently required throughout the field of cell based cancer immunotherapy.
These traditional chemo therapeutic regimens are believed to create a favorable slate of client environment.
Including by depleting host immune cells, so that adaptively transferred cells may arrive.
However, these conditioning regimens are often associated with significant hematologic toxicities and as such creates significant barriers to cell therapy adoption utilization and patient access.
And while much has been made of engineering cell towards they'd post immune cell rejection. It is important to recognize that invasion strategies do not obviate the need for chemotherapy conditioning total allows for.
Cytokine induced activation and persistence of Adaptively transferred cells.
Clinical applications, which we believe extend beyond cell based cancer immunotherapy.
For example, recent publications have highlighted the potential of autologous CD 19 targeted car T cell therapy to reduced drug free remission in patients with certain life threatening autoimmune disease.
We believe the incorporation of ADR technology into our IPSA product platform provides an opportunity to bring novel cell therapies designed to target multiple this regulated sell pipes and achieve a deep reset the immune system for patients with severe.
<unk> auto immune disease.
Turning to the first quarter of next year we.
We plan to hold a research and development day to highlight are industry, leading Ips derived and K and T cell product pipeline with a focus on our clinical stage programs for <unk> malignancies.
We plan to cover our franchises inland former myeloma.
Ml with clinical data updates across our programs.
And key milestones that we seek to achieve in 2023.
In particular with respect to our F. T 596 program in combination with Rituxan AD for the treatment of relapse refractory B cell lymphoma, we.
We plan to review clinical data of approximately 35 patients treated in single dose escalation cohorts ranging from 90 million cells to 1.8 billion cells <unk>.
Recall that despite our request at the time of IMD submission to initiate clinical investigation of the F. T. At 596 program with a three dose treatment schedule based on activity assessments observed in our preclinical studies.
The FDA required us to complete scene.
Escalation.
<unk> two initiating both <unk> treatment schedules.
We are now currently enrolling three.
Two and three dose cohorts at 900 million cells per dose and at 1.8 billion cells produce.
And we plan to review clinical data of approximately 25 patients treated in these multi dose cohorts.
Given that we have observed a highly favorable safety profile with R. F. T 596 program and given the Fda's focus on optimization of dose and dose schedule to maximize therapeutic index. We do believe the assessment of both two and three dose treatment schedules.
These two dose levels is prudent.
Additionally, with respect to our F. T 538 program for the treatment of relapse refractory am now we are currently enrolling patients in the fourth three dose escalation cohort at 1.5 billion cells per dose and expect to complete phase one dose escalation.
By the end of this year <unk>.
During our R&D day, we plan to review clinical data of approximately 30 patients with relapse refractory AML treated in three dose escalation cohorts ranging from 100 million cells to 1.5 billion cells per dose.
In addition to our program reviews, we also plan to share feedback from the FDA under R. F T 516, or Matt designation.
Where our interactions to date have spanned the entirety of our IPSA product platform from IPC generation engineering, and sell banking routine GNP production and drug control strategy clinical development considerations, including optimize dose and dose.
Schedule.
And pathways to approval for patients with aggressive b cell lymphoma.
In September we received positive feedback from the FDA regarding our production characterization and release of <unk> Master IPSA bank for use in the routine manufacturer of drug product.
As well as potential registrational pathways for the treatment of patients with relapse refractory aggressive lymphomas.
Including for patients, who have relapsed or refractory to F. D. A approved at <unk> 19 targeted car T cell therapy.
We were also branded a follow up meeting scheduled for December to review with the FDA key CMC components of our IPSA product platform, including drug product release specification.
We believe we have made great strides through our interactions with the FDA toward our pursuit of pivotal readiness for Ips C derived product platform.
We also plan to highlight are state of the art Multidrug product manufacturing facility located in Poway, California, which is designed to support all phases of clinical development as well as initial commercial launch I am pleased to announce that the facility is now open for G&P production.
And we are well positioned to mass produce multiplexed engineered Ips deriving <unk> and T sell products for the benefit of patients.
I would now like to turn the call over to Ed to highlight our third quarter financial results.
Thank you Scott I'm good afternoon.
Faith Therapeutics, and a solid financial position to advance our pipeline and collaborations.
Cash cash equivalents and investments at the end of the third quarter of 2022, four o'clock approximately $519 million.
And the third quarter of this year or collaboration revenue derived from our partnerships with Jansen and owner of pharmaceutical increased modestly to $15 million compared to $14.2 million for the same period last year.
Research and development expenses for the third quarter increased by $26.7 million to 79 $8 million compared to $53 $1 million for the same period last year.
The increase in our R&D expenses was attributable primarily to increases in an employee head count and compensation, including share based compensation <unk>.
Expenses associated with R&D fees, and third party consultants and and investments made in equipment and materials.
General and administrative expenses for the third quarter increased by five $8 million to $21.6 million compared to $15.7 million for the same period last year.
The increase in our G&A expenses was attributable primarily to an increase in employee head count and compensation, including share based compensation and legal related fees.
Total operating expenses for the third quarter for $101.4 million, which includes $19.5 million in non-cash sure based compensation expense.
Note that in connection with the development of our off the shelf Ips C derived carty sell product candidate 50 819, we previously achieved the clinical milestone set forth in our amended license agreement with Memorial Sloan Kettering Cancer Center.
Which triggered a first milestone payment to Mfk in 2021.
Up to two additional bilestone payments may be owed to Mfk based on subsequent trading values of the company's common stock ranging from 100 to $150 per share.
We assess the fair value of these contingent milestone payments currently valued at $9 million on a quarterly basis.
And the third quarter re recorded a non-cash $900000 non operating benefit associated with the change in fair value.
Our net loss for the third quarter was $83.6 million or 86 cents per share.
Finally, we update our year end guidance for cash cash equivalents and investments.
We had previously guided two year and amounts of at least $400 million and we now expect to end this year with at least $440 million in cash cash equivalents and investments.
Note that in the fourth quarter of this year, we are poised to achieve significant milestones under our collaboration with chance and Ono.
And the achievement of these milestones, including the receipt of associated cash payments is not included in our year end cash guidance.
I would now like to open the call to questions.
Thank you at this time, we will conduct a question and answer session to ask a question. Please press star one one on your phone and wait for your name to be announced could you stand by while we compile the Q&A roster.
Our first question comes from Tennessee Ahmad of Bank of America. Your line is open.
Hi, guys. Good afternoon. Thanks, so much for taking my question.
Up on the the feedback that you've got on the our map meeting with F. D. A.
What kind of commitments do you think any agency when asking for an attorney.
Requirements for registration going forward.
I think that we've been getting that questions on that already.
Recently have this meeting I was just curious.
A little bit more on that thanks.
Sure.
The feedback that we have gotten so far and keep in mind. These are active discussions we're having with the FDA.
Are clinical development strategy in these discussions has focused mostly on.
On the opportunity that exists in the post court T self that setting.
Which we believe is representative essentially the new salvage setting in patients with aggressive stolen.
As such we believe that for instance, it is quite possible to conduct a single arm study in a relatively small number of patients.
That <unk>.
Would likely be the primary endpoint.
And that certainly we would have to follow patients.
Ask a response that said keep in mind that in this patient population based on data from consortiums in the car T cell therapy space.
The response rates are in fact quite low in this patient population postcard T cell therapy.
Often in the teens.
<unk> free survival, which certainly is a benchmark that can be used to follow patients is in the two to three months range.
An overall survival is six months.
So certainly we believe like most therapy as you would have to follow patients but in this particular.
Patient population follow up by its very nature I completely relatively short.
Okay and does that answer your question.
Yeah, maybe just to follow up at do you plan on doing a 516 anyway.
And.
What do you think that you would need to have.
And her and her arm.
Yeah. So I don't I don't want to comment as to whether or not we will be doing 516 or 596, we are actively making that decision asthma have these conversations and of course the end of the year. Obviously 596 is on the table and many of the discussions we're having the FDA or agnostic to product cabinet.
And we certainly believe 596 is a second generation of 516, if you will.
<unk>.
Question is a fair question do we think we would have to have a comparator arm against for instance, we're talking about our view on that is is no rituxan add is certainly not what you would consider a new molecular entity by any stretch of the imagination. We are only for instance, remember, giving a single dose.
<unk> of Rituxan, Mab rituxan might as well so we're not even delivering rituxan lab on by any means it's standard dosing schedule. So we are confident that there are.
Mechanisms, we can use including pointing to historical datasets.
All rituxan in late lying patients that can be used to address the contribution of Rituxan lab, which quite honestly, we think is quite low.
Especially given the this.
This patient population that is progress through multiple lines over <unk>.
And is only receiving a single dose of botox on them.
Okay got it thank you.
Thank you one moment please.
Our next question comes from Michael E of Geoffrey's. Your line is open.
Hey, Scott Ah Congrats on the progress looking forward to these updates.
Alright, two part question one on.
You'll give an update on both of these programs, but they appear to be fairly low doses.
Do you expect that one would see activity here and how do you how should investors attempt to compare this to other things that are out there are given somewhat low doses and secondly on the car T. A bit of the same question, obviously, there's a proof of concept.
Here, but just kind of explain what is the value or.
Strategy, I guess with adding a car T into the mix. Thank you.
Sure.
So the first question actually five 760 update in multiple myeloma.
Keep in mind and hopefully we are clear about this the 576 dose scheduled is currently and we were asked to start by the FDA with a single dose schedule.
So by no means like we've gone through in the past with 596 do we believe a single dose of Nnk cell is the right therapeutic paradigm.
All are preclinical data data from others as well.
Suggests that a single dose of an end queso cannot in fact out compete a single dose of <unk>.
They are very different by our biology T cells expand proliferate much more aggressively than for instance in any case, though.
And so we think again, whether it be 596 or 576, when we're talking about and in case L. Paradigm. The right framework for assessment. These a multi dose framework and so Fortunately with F. T. Five 676, we are transitioning to multi dose much sooner than we did with up to $5.
Where I think I alluded to essentially had to go through 35 patients in full dose escalation.
Before beginning a multi those permanent.
So I think it's important I think this early datasets from from that standpoint, just in terms of just demonstrating safety clearing the safety hurdles. So that we can begin the multi dose experience is important for 576, obviously any early signs of activity would be encouraging, especially since if they were in the mono therapy arm and.
The fact that we're using a novel car so any signs of activity I think in the mono therapy arm.
And the first couple of patients.
Encouraging.
I think with khaki cell therapy again think it's very important for US. This is the first Ips derived car T cell therapy.
Obviously I think it's the first Ips derived car T cell therapy in the world to go into clinical investigation and as we've alluded to certainly on this call.
While most folks I think associate fade therapeutics solely as in Kaesong company our pipeline is.
Expanding and evolving to certainly include T cells, whether they would those be wholly owned programs or programs under our collaborations with Jansen and Ono. So I think continuing to pioneer Ips derive car key cell therapy, including starting with CD 19, where profiles are well understood I think is.
Is is an important experience for us to continue to do as it relates to the specific data again. These are these are early early and dose escalation early doses and I think based on the data that we've looked at in terms of patient profile. I think these patients are not your typical yes, Carter patients I think I even mentioned that.
Probably 50% of our patients are postcard T cell phone therapy in fact.
Got it perfect. Thank you sure.
Thank you one moment please.
Our next question comes from Tyler Van Buren F. Cowan Your line is open.
Hey, guys. Thanks, very much for all the updates regarding the B cell lymphoma data in late January is it more cells or the 1.8 billion <unk> in this case better given the short half life. So basically just comes down to ensuring the strong safety profile has maintained a higher dose and then the second.
<unk> once we get this dose escalation data will you be able to make a decision as to whether you move 51656 am for the first pivotal.
Yeah, Great Great question. So I think the way, we think about it at some basic level, especially given the biology, then K cells, where they do not expand our proliferate like T cells I think there's certainly getting down to sell load right and so if you think about historically, what we've seen in the autologous car T cell space in B cell lymphoma responses.
Happens fairly rapidly and so they tend to happen I think based on what we've seen to date I have an understanding of the autologous world responses often happened in the first two to three weeks and so for US yes, given your purse be given what you brought up certainly in case also have a very short half life NK cells do not behave with respect.
With respect to expansion and proliferation like T cells.
The idea is though I think ultimately comes down to affect our target ratio and maximizing sell load against the target I think there's different ways to try and achieve that with NK cells are certainly different it's schedules that you could potentially look at and so we are looking at for instance, a two and a three dose schedule and I think it's worthwhile.
Confident the FDA is going to inquire given we have such a clean safety profile don't want to understand I think the differences between potentially two different doses.
I think as we get into the first quarter and we do get more experience in greater numbers of patients at the 901.8 billion level using these multi dose schedules, we will be able to make a decision with respect to 516 596.
<unk> and the dose dose schedules.
Great. Thank you.
Yep.
Thank you one moment.
Our next question comes from Nicole <unk> Citigroup. Your line is open.
Hi, Scott Thanks, very much for taking the question just to follow up on the feedback from the FDA with regarding five F. T 516, I just want to get a better understanding of the extent to which the.
The FDA commented specifically on Etsy 596, I understand of course that there.
<unk> finance fixes the next generation version, but they are different products. After also with regard to the specific feedback on the postcard setting and you mentioned.
The primary endpoint following patients for response.
Respect to 516.
How much those comments apply specifically to FG 596.
Or those discussions more going to happen with this follow up meeting the outline and.
December thank you.
Sure and I want to be really clear and you're right. The banner of the discussions is under F. T five <unk>.
Absolutely, we do need to potentially assume that the feedback given relates specifically to F. T 516.
That said.
Questions that we asked in the discussions we're having I do believe can be interpreted more broadly they certainly relate at some level tuna itse product platform as it relates to for instance, making master cell banks or even our manufacturing or product release and I do think the discussions we've been having about the unmet.
Need post car T cell therapy.
How you would design a trial essentially did demonstrate benefit in a postcard T cell therapy.
Posted carty cell therapy, setting could be interpreted reasonably to apply either to 516 or 596.
Okay I got it that makes sense.
And then just a few other little questions here regarding a two five.
The expectation regarding disclosing that target with Ono.
And then I was also wondering with B K O K two product. If you did if Jenson did any work in combo with some of the approved and my leg and prostate cancer.
Thank you.
Yeah, so with respect to you.
Five.
[noise].
We are <unk>, we are in a position where I believe we will very very shortly achieved the preclinical milestone.
That will trigger an option decision by Ono.
I suspect that when one L.
Does your does not exercise their option, but assume for the sake of this discussion that does in fact exercise their option I believe the target will become public at that point in time.
With respect to Janson, Bob if you want to comment on.
Most part the preclinical data that we generated with jansen without getting into all the detail did focus on its potential as a mono therapy.
Okay and then it's usually just holen was really.
Really focused on the unique contribution of the car.
Okay got it and then just one final one on on the F. T 596 doses relation with the multi doses I think if I heard correctly said two doses at 900, and then three at $1.8 billion I was just quite intrigued by the choice of three at $1.8 billion as opposed at.
Two at $1.8 billion, sorry to clarify the kudos schedule includes both 900.
And 1.8.
And the <unk> and the <unk> schedules currently at 1.8.
Ah got it okay. Thank you.
You should think about at some level of sequentially moving through dose dose escalation, Hey, you clear to a one dose level now you can open to dose level. Okay is cleared to dose level you can begin three dose level.
Very sort of.
Systematic way of moving through dose escalation here under the F. T 596 umbrella.
Got it okay. Thank you.
Sure.
Thank you one moment please.
Our next question comes from.
Michael Schmidt is Guggenheim Security your line is open.
Hey, Thanks for taking my questions I had one on your multiple myeloma strategy, perhaps specifically about F. T five seven sex in it.
Right. This initial updated ashworth early but Scott I'm just curious.
What are you looking for in terms of.
The efficacy profile for this program.
Are we looking for a car T. Like efficacy are we looking for something else and then how do you see this profession.
Longer term.
The registration.
Jeremy thinking about.
Something that is going to be applied in combinations are we looking at.
Something more monotherapy nine a late stage setting initially.
Yeah sure.
And my comments.
Keep in mind are relatively early with respect to our evolution of the myeloma franchise.
But certainly I think it's reasonable to believe that a similar strategy can evolve that we believe is playing out and lymphoma. We're certainly patients will receive autologous b CMA targeted therapy.
I think patients will either relapse were fail that therapy and I, certainly think there will be an opportunity to come in with a off the shelf cell therapy in combination with Dara <unk> in.
In patients that have progressed or failed carty cell therapy. So that's one very similar to what's playing out with for instance by 60 596, I do think that will be considered sort of the the post khaki self that upsetting I think will be sort of considered the new salvage and it provides I think lots of interesting opportunity for rapid development.
I also think of labor designing our product candidates. Obviously have features and functionality that are designed in fact to synergize with the monoclonal antibodies better used early and often and care and so are I would say other strategy for development is not necessarily to go compete head to head.
At a memorial Sloan Kettering your MD Anderson of the world's with an autologous product, but use the fact that these monoclonal antibody regimens are given it early and care use play to our advantage that we have an off the shelf cell therapy.
Obviously to the extent, we continue to have a differentiated safety profile, we think thats cell therapy could be delivered in the community setting and therefore reach into earlier line settings and reach patients earlier and care in the community setting with them off the shelf product.
Okay that makes sense.
To follow up on your <unk> strategy Chthonophagia nearing a a decision point here and one Q about 5165.
Is this going to be an either or decision Scott or is there a scenario where you could move both programs into a registration studies next year.
I think it's I think it's very likely we would consider a single product, Canada, either one or the other I think at the end of the day.
Well you know again, having acted conversations with the FDA I think a reasonable assumption to work on.
That if you do run for instance, a late lines study postcard T <unk>.
A reasonable assumption is that that might be accelerated versus full approval and that a confirmatory studies might be required. That's all TVD, we're having active discussions, but certainly if that were the scenario that would play out it would behoove us to sort of consolidate the franchise around a single product I, obviously think 596.
Second generation product candidate if you will.
Thank you.
Sure.
There's certain assumptions in there too certainly that 515 500 600, similar safety profile that would allow for that as well.
Thank you.
Moment please.
Our next question comes from the <unk> ship asking P. P security. Your line is now okay.
Hi, Thank you for the question you have a lot of programs here both your own internal programs in multiple that you could opt in the next couple of years and I Wonder if you could talk about how you're thinking about portfolio prioritization.
Then related that with that do you have any guidance and R&D burned for 2023.
Start to take these programs for it.
Yeah, I mean add can address the latter one.
I don't think today, we expect that burn will actually go up substantially while there.
As you rightly pointed out some are emerging programs, including clinical programs.
In mind that as it relates to the Jansen programs early development actually preclinical development as well as early clinical development is fully paid for by Janson.
The program that we announced today for instance, F T 555, and my Loma as well as the preclinical development of the cocktail K two T cell program. All of that is funded by Jansen until we fate decided to make an opt in decision and that often decision.
You should think of occurs essentially when dos and don'ts schedule has been selected for registration study.
So those programs I don't tend to think of all or part of states burn certainly in 2003 and and maybe into late 24 Ono is very similar half the programs funded by owner.
And half is funded by state and we do think that there are early milestones under the <unk> program, including option exercise as well as early phase.
Phase one milestones that essentially make the program cost neutral to feed therapeutics from that perspective.
I do expect say therapeutics and will discuss this more at.
Our R&D I, certainly think we are going to prioritize and rationalize our program or programs in our pipeline as you know we have first and second generation product candidates certainly we just talked about that in lymphoma. It's also true in in my room as well would actually 53576.
Alright, thank you.
Sure.
Thank you one moment please.
Our next question comes from Peter and lasting a sparkly. Your line is now open.
Great. Thank you I apologize.
During the call late but the updated data for <unk>.
Should we expect that has that kind of more of a January event is it unless they thing in January or targeted medical okay. Sorry, Yeah, sorry will do will do a analysts will do in a R&D day in the first quarter of next year.
And at that R&D day, certainly the lymphoma data.
With respect to 516, and 596 will be in focus during that R&D day will also update our other disease franchises and he not a large malignancies, including my Loma and AML, we will.
Provide I think a meaningful update with respect to our discussions with the FDA under Armandt as it relates to our product platform.
As well as development strategies, and I think we'll focus a bit on our new new manufacturing facility that we're launching in the capabilities and unique value of.
Mass producing ips cells for patients with cancer.
<unk>, we will I think hold a fulsome R&D day in the first quarter to.
Discuss those topics.
Great. Thank you and then to the <unk>.
We do expect that will be a single study.
Kind of what drives the difference between the decision between flatulence. It is 596.
And would you potentially running.
C plus rituxan lift.
This is <unk>.
Yeah, No I think I think our our view is that the postcard T cell steady setting is could.
Could be considered a salvage setting I think in a salvage setting and cancer you could absolutely run a single arm study.
Rituxan Mab is not a new molecular entity.
And I think there are absolute we do not even give rituximab on standards schedule.
I think there are recent examples where folks have secured certainly accelerated approval in combining with therapies that are used that are not new molecular entities and.
I certainly think there are ways to keep in mind that folks have progressed or most patients on our study have gone through at least multiple lines of a standard Rituxan Lab regiment and so I think there are multiple different ways to demonstrate.
The unique value of the product without having to run a controlled study.
Perfect.
Photo question around the T C editing and TCR less might be S. C. Just curious if there's a stable if you're seeing kind of genomic rearrangement since we've kind of seen in some of the <unk>.
It it's it's ellenwood approaches.
Yeah, I'll I'll, let Bob talk about it but I think at a conference recently either <unk> we highlighted.
Tenure stability of Ips derived engineered master cell bank, but <unk> sure no. That's a great question Scott mentioned, we highlighted that at Ace GCT, but.
Given line, we select a corner line and that quote on buying gifts interrogated before the Bachelor Stopbank has made its interrogated after the master cell Bank has made it gets interrogated after engineering strategies as well. So we have a fall color of different genomic stability assays, and we're very confident in art and the stability of our product.
Which one just the final question just around the state.
They could we get a sense of your ability of responses from the lymphoma data.
Sure I think we're going to present their ability a response I think keep in mind that we've just recently moved.
To the multi dose schedules with two and three doses. So obviously those patients are going to be less mature with respect to follow up.
Great. Thank you so much.
Sure.
Thank you one moment please.
Our next question comes from Gil Plum of maiden Lane is that correct.
Hi, good afternoon, thanks for taking our questions.
Maybe a quick questions on S. T M 819, and kind of the data that.
Partially disclosed this morning on safety looks pretty safe I mean, when you compare it to its allergy next year, So I'd love to hear your thoughts on that.
Sure I mean.
It's early and jokes escalation, so I'm I'm not I wouldn't read too much into it one way or another the one thing I would keep in mind as we are using a novel car construct a <unk> car construct which you can consider to be sort of uniquely different than either <unk> eight four.
Mbd.
So whether or not that car construct is key.
Yielded different safety profile, I mean time will tell as we continue through dose escalation.
But so so so far so far we've seen a relatively clean safety profile with FTA 19, yes.
Okay.
And maybe a broader question solid tumors so.
Assuming you can use multiple different antibodies theoretically you could go after multiple Attica Jones, and a solid tumor, especially as the disease progresses.
Any thoughts on that.
Yeah, no absolutely absolutely I think I think that's one of the things we are potentially excited about is the potential to ultimately you could combine with an array of monoclonal antibodies over a period of time. In addition, I think one of the reasons were also really excited about potentially combining with <unk> for instance, actually 536 plus.
They have some Abby now achieving sort of you know.
Not just dual antigen targeting that you're hitting three antigens with respect to that combination. So yeah, absolutely I think the I think the that's I think that's one of the benefits of a cell therapy and FDA approved monoclonal antibody combinations.
Alright. Thank you for taking my questions then congrats on your progress.
Thank you.
Thank you one moment.
Our last question comes from Matthew Bigler Arco Your line is open.
Hey, guys, an extra squeeze them in.
Scott I thought it was interesting in your prepared remarks, you specifically mentioned 536 data at 15, but not 538.
Should we be reading into that.
Yeah Yeah.
Yeah don't we will have five two.
538, we do have data I think it will be eight to 10 patients.
First dose level three different monoclonal antibody combinations I believe.
It was simply for brevity [laughter] got it I think I think I think it went too long to begin with my comments were too long to begin with so not.
Not not everything makes it into the script, but yes, now we will be presenting F. T 538, <unk> I think I think the poster covers about eight to 10 patients at the first dose level three different monoclonal.
Understood looking forward to your thanks.
Sure.
Thank you I would now like to turn it back to Scott for closing remarks.
Great.
Thank you all for participating in today's call and look forward to seeing you know hopefully some of your next week at <unk>.
Take care be well.
Thank you.
Concludes the program you may know discount.
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