Q4 2022 Fate Therapeutics Inc Earnings Call
Given this positive momentum under the Janssen collaboration we were disappointed to first learn in December that Janssen desire to significantly reduce its 2023 spending under the collaboration.
As well as modify certain key financial <unk>.
And intellectual property terms of our agreements.
Unfortunately, we were not able to align with Janssen for continuation of our collaboration on revised terms and Janssen exercised its right to terminate the agreement in early January .
As a result, all research and development of collaboration candidates are being discontinued and we expect to complete the wind down of the collaboration in early April at Champs is expense.
As a consequence of the termination we were required to significantly reduce our workforce and operating expenses.
We also completed a strategic review of our product candidate pipeline and elected to prioritize the company's most innovative and differentiated product candidates, having the potential to address large unmet clinical needs. This.
This strategic review resulted in most notably the discontinuation of our first generation FTE 596 car NK cell product candidate for the treatment of B cell lymphoma.
While our clinical experience with a three dose treatments scheduled for Ft 596 was in its early stages.
We made the strategic decision to prioritize the advancement of our second generation CD 19 targeted car NK cell program referred to as FTE five Q2.
Ft. Five Q2 incorporates five novel synthetic controls of cell function designed to increase NK cell potency.
Hence functional persistence.
And reduce or eliminate the need to administer conditioning chemotherapy patients.
Taken together, we believe <unk> has the potential to improve safety and clinical benefit.
Patients earlier in care, including in the community setting.
And seamlessly combined with standard of care regimen.
Including those that contain CD 20, as well as CD 38 targeted monoclonal antibody therapies.
Importantly, we also believe that novel synthetic controls integrated into <unk>.
Rod Hema programs potential therapeutic application.
To include both hematologic malignancies and autoimmune disorders.
In the first quarter of 2023, we reduced our workforce to approximately 220 employees in order to provide the necessary cash runway to achieve key clinical milestones.
Cros are prioritized Ips derived car NK and car T cell programs.
This was an exceptionally difficult and painful steps and.
And we're greatly saddened to have had to move in this direction.
Our employees continually demonstrated the highest level of dedication and commitment to our mission and.
And we want to extend our deepest appreciation and wish them great success in the future.
We are thankful that many of our employees have already found their next home within a thriving biotechnology communities at San Diego and San Francisco.
Before I highlight the key program initiatives that we're focused on for 2023 I would like to turn the call over to Ed to discuss our financial results for 2022.
And our expectations for the first quarter of 2023.
Thank you Scott and good afternoon.
<unk> therapeutics is in a strong financial position to advance our prioritized Ips derived car NK and car T cell pipeline.
Our cash cash equivalents and investments at the end of the year, including net receivables from success based milestones achieved in the fourth quarter were approximately $475 million.
In the fourth quarter of 2022.
Our revenue derived from our partnerships with Janssen and Ono pharmaceutical increased significantly to $44 4 million.
Compared to $17 1 million for the same period last year.
We achieved multiple success based milestones within our collaborations which resulted in nonrecurring revenue in the amount of $25 $5 million in the quarter.
Research and development expenses for the fourth quarter increased by $17 7 million to $87 2 million compared to $69 5 million for the same period last year.
The increase in our R&D expenses was attributable primarily to increases in employee head count and compensation.
Including share based compensation and expenses associated with sub license fees and the use of third party consultants.
General and administrative expenses for the fourth quarter increased by $4 7 million to $21 $6 million.
Compared to $16 9 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 fees.
Total operating expenses for the fourth quarter were $108 $8 million, which includes $19 $4 million and noncash share based compensation expense.
Note that in connection with the development of our off the shelf Ips derived car T cell product candidate <unk> hundred nine 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 <unk> in 2021.
Up to two additional milestone payments may be owed to MSA based on subsequent trading values of the company's common stock ranging from 100 to $150 per share.
We assessed the fair value of these contingent milestone payments currently valued at $3 $9 million on a quarterly basis.
In the fourth quarter, we recorded a non cash $5 $2 million non operating benefit associated with the change in fair value.
Our net loss for the fourth quarter was $56 4 million or <unk> 58 per share.
As we turn our focus to 2023 I want to share a few thoughts regarding the restructuring we announced on January 5th and how this will impact our GAAP financial results. This year.
In connection with the termination of the Janssen collaboration in the first quarter of 2023, we expect to recognize as revenue $41 $2 million that currently sits on our balance sheet as deferred revenue.
Additionally expenses associated with closeout activities are expected to be reimbursed and will be recognized as revenue in the first quarter of 2023 as well.
As previously announced we have discontinued a number of earlier generation Ips derived NK cell program.
While we expect a more focused pipeline to generate significant cost savings and operating leverage.
The anticipated cost savings from a reduction in force are not likely to be realized until the second quarter of this year.
We expect to incur charges of approximately 12 million to $16 million for severance and other employee termination related costs in the first quarter of this year.
Additionally, we have many patients that remain on study for programs that have been discontinued.
This includes patients who were enrolled in our ft, 516, and Ft 596 clinical studies and continue to maintain an objective response.
And we have elected to follow these patients for up to one year to assess durability of response.
As a result costs and support for these studies will dissipate over the course of the year.
I would now like to turn the call back to Scott to discuss our key program initiatives for 2023.
Thanks, Ed as we look ahead to 2023, we have focused our operations on advancing our most innovative and differentiated Ips derived car NK and car T cell product candidates for patients with cancer and autoimmune disorders, and we have substantially reduced our expenses with the intent of providing the necessary cash runway.
To achieve key clinical milestones across our programs.
We are now enrolling multi dose treatment cohorts with ft 576, our multiplexed engineered car NK cell product candidate for multiple myeloma.
In addition to its novel B CMA Binder Ft 576 also incorporates our proprietary high affinity non cleavable <unk> FC receptor, which is designed to augment antibody dependent cellular cytotoxicity and enable combination with CD 38 targeted Monaco.
Antibody therapy for dual antigen targeting of plasma cells.
Importantly, the potential for enhanced clinical activity in combination with a CD 38 targeted monoclonal antibody therapy is enabled through the knockout of <unk> 38, which eliminates the possibility of CD 38 mediated fracture side.
Despite the recent launch of two FDA approved the CMA targeted autologous car T cell therapies, we believe an off the shelf multi antigen targeted product candidate that is uniquely designed to synergize with CD 38 targeted monoclonal antibody therapy may offer an attractive and differentiated value.
<unk> proposition at.
At the 2022 Ash annual meeting in December we presented interim phase one clinical data from the first nine patients treated with a single dose of <unk> 576, as monotherapy and in combination with CD 38 targeted monoclonal antibody.
Clinical data from the single dose treatment cohorts in heavily pretreated patients showed encouraging clinical evidence of <unk> targeted activity.
And a favorable safety profile, indicating the potential for administration in the outpatient setting.
In particular of the three patients treated with a single dose of Ft 507, six in combination with CD 38 targeted monoclonal antibody.
The first dose level of 100 million cells, one patient achieved a partial response, notably translational data from this combination cohort showed rapid and selective depletions.
The activated host immune cells through the first month of therapy.
This suggests that CD 38 targeted monoclonal antibody may also serve as a conditioning agent to mitigate the risk of rejection of ft, 507, six and potentially reduce the need for administration of intense conditioning chemotherapy.
We are currently enrolling two dose cohorts as monotherapy and in combination with CD 38 targeted monoclonal antibody therapy.
At 300 million cells per dose.
And upon clearance, we plan to open and assess three dose treatment cohorts, starting at 1 billion cells per dose.
In keeping with our commitment to develop highly differentiated product candidates with the potential to address large unmet clinical needs. We are advancing our second generation CD 19 targeted car NK cell program referred to as FTE $5 <unk>.
Leveraging our unique ability to create multiplexed engineered Ips fee lines FTE five to incorporate five novels that it controls of cell function.
Designed to increase NK cell potency enhanced functional persistence and reduce or eliminate the need to administer intense conditioning chemotherapy to patients.
Notably <unk> is the first product candidate to incorporate our proprietary alloimmune defense receptor or ADR technology.
Our synthetic ADR receptor is designed to target or one DB expressing activated host immune cells and.
And upon target engagement to potentiate, the cell product <unk> III data signals.
Unlike cell engineering approaches that are designed to passively.
The host immune system, which do not obviate the need for intensive chemotherapy conditioning to induce cell activation and functional persistence.
Our proprietary ADR technology is instead designed to feed off of the host immune system to promote its activity.
We believe the design of <unk>, two has the potential to improve safety and benefit reach patients earlier and care, including in the community setting.
And seamlessly combined with standard of care regimens, including those that contain targeted monoclonal antibody therapies.
Importantly, we also believe the novel synthetic controls integrated into 5% to broaden the program's potential therapeutic application to include both hematologic malignancies and autoimmune disorders.
At the 2022 Ash annual meeting in December we presented preclinical data demonstrating that ADR armed Ips derived car NK cells resist host mediated rejection.
And in fact expand persist and maintain anti tumor activity in the presence of the allo reactive T cells.
These preclinical data provide proof of concept that ADR arms.
ADR arm cell therapies have the potential to persist and induce potent anti tumor activity without requiring intense conditioning chemotherapy.
We intend to submit an investigational new drug application to the FDA in mid 2023 to.
To commence a phase one study of <unk> in combination with Rituximab for the treatment of B cell lymphoma.
Including without administration of intense conditioning chemotherapy to patients.
We are also particularly interested in expanding our clinical investigation of <unk> to be on the oncology two auto immunity.
Where recent publications have highlighted the potential of autologous CD 19 targeted car T cell therapy to induce drug free remission in patients with certain severe autoimmune diseases.
Believe the specific functional elements integrated in two five to two <unk>.
They have the potential to engage and suppress the broad array of destructive drivers of autoimmune disease pathology.
Including auto antibody secreting b cell expressing CD 19 auto antibody secreting plasma cells.
Pressing CD 38, and auto reactive and helper T cells expressing <unk>.
We are also excited with the progress of our Ips derived car T cell pipeline for the treatment of hematologic malignancies and solid tumors.
Dose escalation is continuing and our landmark phase one study of our FTA 19, CD 19, <unk> targeted car T cell product candidate, which to our knowledge is the first ever T cell product candidates manufactured from a clonal master <unk> line to undergo clinical investigation.
FTA 19 incorporate several first of kind features including the integration of a novel <unk> car construct into the Trac locus, which is intended to promote uniform car expression.
<unk> T cell activation and exhaustion and prevent graft versus host disease.
We continue to believe a meaningful portion of the B cell malignancy patient population will be unfit for autologous car T cell therapy for numerous reasons, whether that be due to logistical barriers prior therapy or disease aggressiveness and these patients will require in effect.
<unk> off the shelf therapeutic alternatives.
At the 2022 Ash annual meeting in December we presented interim clinical data from our ongoing phase one study of <unk> 19, which showed a favorable safety profile and demonstrated objective responses in heavily pre treated patients including in patients who were not eligible for.
Or had previously failed autologous CD 19 targeted car T cell therapy.
VA patients with aggressive large b cell lymphoma treated with a single dose of FTE 19, ranging from 90 million cells to 360 million cells too.
Two patients were naive to car T cell therapy.
One of whom achieved a complete response and six patients were previously treated with car T cell therapy to whom achieved an objective response, including a complete response in a patient with <unk> previously treated with seven prior lines of therapy, and who did not.
Response to autologous CD 19 targeted car T cell therapy.
Dose escalation is currently ongoing in single dose treatment cohorts at 540 million cells and T cell lymphoma.
And that 180 million cells and chronic lymphocytic leukemia.
Although autologous car T cell therapy has shown significant efficacy in treating hematologic malignancies. It's application to solid tumors has been hampered by several factors, including tumor associated antigen heterogeneous heterogeneity inefficient car T cell trafficking to the tumor.
And an immunosuppressive tumor tumor microenvironment.
Our multiplexed engineered Ips derived car T cell product platform is designed to specifically address these challenges and enable the safe and effective treatment of solid tumors.
Under our collaboration with Ono, we are conducting IND, enabling activities for <unk> five.
Multiplexed engineered.
<unk> derived car T cell product candidate targeting targeting her to express in solid tumors.
The product candidate incorporates seven novel synthetic controls designed to enhance effector cell function and overcome unique challenges in treating solid tumors.
The <unk> 37th annual meeting held in November we presented preclinical data of FCA, two five which highlighted the differentiated targeting profile of the product candidates novel or two targeted binding domain as well as the functional activity of the product candidates novel synthetic control.
Including to promote cell trafficking.
Redirect immunosuppressive signals in the tumor microenvironment and induce T cell activation.
We expect to submit an IND application to the FDA in 2023 to commence a phase one study of <unk> for patients with her two positive solid tumors under our collaboration.
While it certainly has been a difficult two months and these continue to be challenging time for the biotechnology sector.
I'd like to conclude by thanking the employees of fate therapeutics we.
We are pioneers the first to develop off the shelf Ips derived cellular immunotherapy.
We are resilient embracing uncertainty and forging ahead.
And we remain passionate and committed to leveraging our proprietary <unk> product platform and bringing highly differentiated product candidates for patients with the potential to transform outcomes and change lives.
Thank you I would like to now open the call to any questions.
Thank you ladies and gentlemen, thank you I have a question or a comment at this time. Please press star one on your telephone. If your question has been answered with the withdraw yourself from the queue. Please press star one again in the interest of time, we ask that you limit yourself to one question and if you have further questions feel free to get back in the queue. One moment for our first question.
Our first question comes from Tyler Van Buren with Cowen Your line is open.
Hi, guys. This is this is sarah on for Tyler.
I'm just wondering if you guys can.
Tell us when do you plan to present, the next data set for 507, six and 819 with that.
B at Ash or are you thinking and investor events. Thanks.
Thanks for the question I think it's a little too early for us to commit to the data update around both of those programs. We're currently working with the modified team at fate therapeutics to target and focus of our enrollment on the dose cohorts that I, specifically mentioned during our call I think in a couple of months, we'll be able to give.
Specific update with respect to the timeline for a data disclosure whether that be at ash or an investor event.
Thank you one of them before our next question.
Our next question comes from Eagle Ghansham, just with Stifel. Your line is sorry with Citi. Your line is open my apologies.
Hi, This is carly on for Yigal, Thanks for taking our question.
We wanted to ask about slide.
Slide seven six as well.
I wanted to get your updated thoughts on the competitive positioning I guess should we be thinking about with HMA hospitals.
From an efficacy perspective.
And you mentioned you started.
Multi dose cohort.
Totally early but just curious when you think you may have enough data to really understand the profiling.
I will now subject again.
Registrational pathway. Thanks, very much sure sure I think as we've seen with NK cells with our other programs I think a three dose schedule of NK cells is going to be important to create the right area under the curve. If you will with respect to sell load to most effectively attack the tumor.
And so we are completing a two dose schedule right now with ft 576, as a monotherapy and in combination with CD 38 at 300 million cells.
Once that dose those dose cohorts clear, we will move to the three dose schedule at 1 billion cells per dose.
This year, we certainly believe we will be dosing at a more optimized NK cell number optimized treatment schedule for NK cell using three doses and at higher doses and importantly, we are assessing the potential to combine with Dara <unk>, which we've seen at.
At least in the early translational data that we have seen sort of the dampening. If you will of the allo reactive T cell compartment.
When delivered in combination with a monoclonal antibody.
I think in terms of the competitive landscape look I think what we've seen so far is that unfortunately in multiple myeloma. There are no curative therapies. There will continue to be patients that will progress through multiple lines of therapy.
I think <unk>.
CMA is emerging it appears to be a more durable target. So I do think there'll be multiple lines of the CMA targeting therapy.
That said I think with an off the shelf platform. The full promise of an off the shelf platform is to be able to reach patients earlier and care in the community setting where most myeloma patients are treated.
And ideally too.
Deliver and plug into a standard monoclonal antibody regimen with CD 38 without intense chemotherapy conditioning until ultimately our objective with 576 is to develop a highly differentiated product candidates.
It Synergizes with CD 38 targeted map.
It can be delivered early and often to patients as part of the standard chemotherapy regimen.
Thank you one moment for our next question.
Our next question comes from David <unk> with SBB Securities. Your line is open.
Yeah, I Wonder if you could talk a little bit more about D for MTBE targeted ADR for FY <unk>.
U shape through several conferences last year published a lot of other interesting stuff.
Fantastic some active and I Wonder why go and prioritize the first clinical program with just ADR versus some of the other assets are a combination of that.
Sure I mean, I can talk to at a high level I mean, there's three different programs that we've looked at primarily with respect to let's just call. It sort of an ADR platform. There is the potential to target for <unk> expressing allo reactive.
Hi.
Immune cells, which happens to include both key and NK cells importantly, and so with <unk>. We certainly think we are.
Has the potential to address the complement of host immune cells that may mitigate rejection and importantly, with that specific ADR technology.
The potentiation signal to the cell as well, which we also think is important and differentiated from the passive approaches the.
The other approaches we've looked at are certainly CD 38 on developing a car against CD 38, we think that's a very interesting approach again similar to the 401 BB strategy CD 38 will take out or to be able to defend the sell against.
Activated allo allo activated cells, whether they be NK cells or T cell expressing CD 38, So we think thats a similar type of strategy that we also like and obviously in the format of a car can activate and potentiate the sell a differentiated approach the third strategy I'll, let Bob talk about but is this CD 54.
<unk> <unk> 58 knockout and we think Thats an interesting approach, but we think it's primarily interested in the context of the cell defending itself against an NK cell therapy attack, which.
Which we do not think is sort of a prevalent mechanism of rejection and importantly, it doesn't provide an activating signal in this current 112.
That's right Scott.
Just a follow up what Scott is mentioning $54 58 knockout comes into play when youre not cannot be to them and that was an experiment that we worked with our collaborator <unk> malburg as a solution for RP to have knockout strategy, where we fit it feel strategies such as <unk> 47 of our expression of our HLA E come up short.
So in this perspective $54 58 does play a role, but just to echo what Scott said earlier about ADR and our current focus.
As I really really believe as Scott outlined ADR is a true replacement cycle. It helps protect against an allo rejection. It helps potentiate and also create space and these are the steps that we believe <unk> brings to the table and so we feel that ADR is the focus but.
The strategies are there and we will continue to pursue our stealth program such a manner.
Thank you one moment for our next question.
Our next question comes from Michael Yee with Jefferies. Your line is open.
Hey, good afternoon hit hard on for Mike.
Two questions one on the actual pipeline and second on financials.
On the pipeline can you kind of let us know what the bar is and what the expectations are on efficacy for both.
Seven six and 819 like what are you looking for in terms of.
The bar and then secondly on the financials as of $12 million to $16 million going to be just a one time incurring expense for Q1 and we expect.
Im expenses overall to drop.
Talk a little bit about that and the potential for combination of sequencing of therapies.
Yeah with respect to the 576 program and the bar, we're looking for obviously, it's a competitive landscape and we're trying to develop a differentiated therapy part of the differentiation that we're.
We're looking to see is it is essentially a cellular therapy that can be given in combination with monoclonal antibody therapy, which is used across multiple lines in treating patients with multiple myeloma.
This is the monoclonal <unk> targeted monoclonal antibody antibody therapy may serve as a conditioning agent as well.
So we do believe that we can number one develop a cell therapy that can plug into standard of care regimen number too because it is an off the shelf cell therapy potentially reach patients earlier and in an outpatient setting and number three potentially reduce the intensity of chemotherapy conditioning that is delivered to patients.
So we do think we can have a very differentiated safety safety profile and deliver significant clinical benefit to patients and again I think thats relevant across lines of therapy as there are no curative therapies for myeloma.
With respect to financials I'll turn it over to Ed.
Yes, the majority of the $12 million to $16 million as outlined in the prepared remarks, we will occur in the first quarter with related with respect to severance and other employee termination related costs. Some of that will be covered by the wind down of the Janssen collaboration as well. So that will also be occurring in the first quarter, what remains that as sort of the rhythm of the business.
Afterwards, and as sort of we indicated while we have discontinued a number of programs earlier generation of Ibs C drive NK cell programs. We do have follow up particularly for patients that are ongoing in response to both ft 506 in ft 596, and so we will follow those patients for up to an additional year that will require <unk>.
With human resources as well as financial resources to do that so a lot of that benefit from a financial leverage perspective cost savings perspective will come in the second half of the year and work its way through with the remainder of 2023.
Thank you one moment for our next question.
Our next question comes from Cristina <unk> with Bank of America. Your line is open.
Hi, good afternoon. Thanks, so much for taking my question.
One for me.
Any clinical update to.
To be presented at medical conferences, this year and if so.
Which of the program that you've spoken about could be up for updated data from here. Thanks.
Sure I think the guidance that we'll give with respect to data disclosures, we'll probably give that guidance.
You may call.
We obviously are just getting our feet under us with respect to executing on our $576 19 studies.
And so I think in the May call, we'll be in a better position to outline the cadence.
With respect to the data updates for those clinical programs.
Thank you one of them for next question.
Our next question comes from Michael Schmidt with Guggenheim. Your line is open.
Yes.
Hey, good afternoon. This is ebay on for Michael Thanks for taking our questions.
What clinical learnings did you gain from Youre experiencing solid tumors with $5 38, and $5 36.
Type of enhancements do you think will be necessary to be successful in solid tumors and do you have more confidence in T cell based therapies in solid tumors or NK cells. After your initial experience. Thank you.
So unfortunately, our experience with NK cells in solid tumors is fairly limited we have dosed patients with both ft $5 38 at low dose levels.
We also in combination with monoclonal antibody, we also dose patients with ft 536, a car NK cell product at very low dose levels and we have limited patient experience.
I do believe NK cells will play a very important role in solid tumors. We have in the solid tumor experience with our car NK cell programs, we have seen anti tumor activity in the clinic.
But as we've noted if you look at for instance, the product candidate FTA, two five which is a T cell product candidates that product candidate in addition to being a T cell.
Additional synthetic controls built into that which are specifically designed to overcome some of the challenges with solid tumors, namely for instance, homing and resisting the immunosuppressive signals in the tumor microenvironment.
Those features were not built into ft 538, they were not built into ft 536. They are built into FTA, a two five and we do think they are important features.
As I mentioned I do think that.
Cell therapy can synergize with monoclonal antibodies.
In packing solid tumors and I would also note that our FCA two five product.
These include one of the first product candidates that I can think of does actually include while being a T cell. It also includes our high affinity non cleavable CD 16 receptor. So we do have the potential with our <unk> product candidate to actually through the car target her too but.
Also leverage monoclonal antibody content to achieve dual antigen targeting with our T cell product candidates, so and making some of the hard decisions that we were confronted with we felt like advancing FTA two five in solid tumors.
Was the right approach given the specific and additional functionality built into ft. At two five it wasn't necessarily a decision about NK cells versus T cells. It was about.
What we think is a multitude of functionality that is going to be required to successfully have profound impacts in solid tumor.
Thank you one moment for our next question.
Our next question comes from Peter Lawson with Barclays. Your line is open.
Hey, Good afternoon. This is Alex on for Peter Thanks for taking my question.
Just one on the 576 program here do you plan to go to higher than a three dose treatment regimen and I'm just trying to get a sense for.
How youre thinking about the dosing schedule and if you feel that.
Schedule has been explored sufficiently here in this indication in multiple myeloma.
Well certainly some of the dosing.
Some of the learnings, we're taking from our lymphoma programs, where we have dosed.
And typically dosed three doses upon patient one starting with 570, <unk> sorry with 516 in lymphoma.
And obviously with 596, we progressed from one to two to three doses I think given just sort of the biological sort of properties of NK cells and how they different from T cell, including their relatively short half life and their inability to expand like a T cell would I think a multi dose treatment.
<unk> schedule is important.
And I think we're in multiple myeloma, we are excited to start the three dose treatment schedule where.
We're starting at 1 billion cell the protocols certainly allows us to continue to dose escalate beyond 1 billion cells.
Thank you one moment for our next question.
Our next question comes from Andrew <unk> with Goldman Sachs. Your line is open.
Good afternoon. Thanks for taking my question Scott maybe just.
Just given the profile you have seen to date with your NK cell programs and what's been going on with your competitors and can you help us understand your level of confidence in this modality do you see a scenario, where you would be constantly an ips derived T cell company instead.
Yes, I think I think honestly with respect to NK cells I think what we have learned is that if you again I do think NK cells have significant activity, we've certainly seen that.
Across multiple NK cell program.
I think if you really want to develop a highly differentiated product though.
Especially in the context of competitive landscapes like lymphoma like myeloma.
Need a unique product offering and a unique product offering I think will require sophisticated and multiplex to engineering I think he will have to include multiple functional elements.
You will have to potentially develop deliver multiple mechanisms of action.
And I think you potentially will <unk>.
Ideally with an off the shelf cell therapy will need to begin to differentiate one of the modes of differentiation as well as moving away from intense chemotherapy conditioning.
With an off the shelf cell therapy, the promise of an off the shelf cell therapy is to reach patients early and often in care with an NK cell therapy I do think it has a unique and differentiated safety profile, which allows you to reach into the community setting.
But I do think you need to that will requiring multiplexed engineered solution.
It will require the delivery of multiple mechanisms of action and the highest level. There are some of the decisions that we made to favor our multiplexed engineered product candidates that can synergize and combined with monoclonal antibody that can be given earlier and care and that potentially do not require intensive chemotherapy <unk>.
Additionally, as part of the treatment regimen.
Thank you one moment for our next question.
Yes.
Our next question comes from Ben Burnett with Stifel. Your line is open.
Hi, Good afternoon. This is currently an island, Florida Denver <unk>. Thank you for taking our question.
With regard to your next Gen. TV 19 car NK cells Pelikan <unk>, what gives you confidence on the level of transformation of the enhanced anti tumor activity in prestige 10, you've observed.
With your ADR technology in preclinical studies.
Yes, I mean, the benefit one of the benefits that we have and again, it's preclinical data, but one of the benefits. We have is that an Ips C platform allows you to create very homogeneous key system product and so we are able to raise multi generation.
Product candidates against each other for instance, $5 16 596, five Q2, we can do literally head to head studies.
Of of multiple different product tenants against each other and I think part of the confidence as I mentioned, when we had to make the difficult decision with respect to 596, we had very limited clinical data with a three dose schedule at higher dose levels.
I think one of the essentially what gave us confidence though in addition to we think we need obviously to compete in the competitive landscape you need a highly differentiated product candidate and we think <unk> has some very unique features that allow for that differentiation, but certainly all of the preclinical experimentation we've done over the past 18.
<unk> racing $5 16 against 596 against 522 in some very difficult and stringent models, including models that are designed to promote allo reactivity.
Really gave us the confidence to make the decision in advancing five future.
I don't know Bob do you have anything to add to that.
That's right Scott.
Credit between potency and avoided rejection.
On the potency of <unk> 52, Leverages, a five three APAC zone, which at 509 six did not and then on the and the survival factor of <unk>.
Our our allo environment that Scott mentioned ADR gives you it a unique ability that other NK cell phone app.
Thank you one moment for our next question.
Our next question comes from Robyn <unk> with Jefferies. Your line is open.
Hi, This is bill on for Robyn.
Do you envision the possibility of bolstering our competitive edge in multiple myeloma in the near term.
Both $5 76, and 890 to clear out plasma cells and easy to maintain positive progenitor cells, while harnessing designate worlds.
So we absolutely have preclinical models, where we've combined the NK cells and T cells.
We're not prepared to discuss publicly our strategy for first launching combination with NK cells and T cells I do think there's significant value.
Being able to.
Let's just say unite.
Uneaten adaptive immunity.
And it is a strategy for instance that we've embedded into for example, FTA two five where we've combined where we've engineered the highest entity CD 16 receptor into the backbone of a T cell.
So I would say based on our experimentation pre clinically.
We certainly are excited about the potential to unite and indeed and maintenance DAP immunity, we think theres multiple ways to accomplish that but certainly given the off the shelf nature of our product candidates creating.
Our defined composition of both cell types or.
We're delivering for instance, a T cell followed by an NK cell or vice versa.
Both our strategies that I think we can pursue.
Thank you one moment for our next question.
Our next question comes from Mara Goldstein with Mizuho. Your line is open.
Great. Thanks, so much for taking the question.
Jeff.
A question on an FTE 819, and not so much on 819, but really kind of a state of the world right now and given what we're seeing from data and registration with respect to bi specifics and how you think about advancing 819 and then just on our next Q2 can you talk a little bit about.
Well what the.
No.
<unk>.
What are the rate limiting issues are that for getting fair initiating an autoimmune program.
Sure. So with 2019 to begin with look it's the first Ips derived car T cell period, I think it's really important for us to advance that product candidate and understand its potential are we truly making ips derived car T cells, what does the activity level look like obviously, we have.
Very nimble and versatile platform, which we can improve upon shortcomings whether that be for.
Hematologic malignancies or solid tumors. So understanding the activity level of 2019, I think is really important that said like I said I, absolutely believe that there will continue to be room for.
Efficacious CD 19 targeted therapies, absolutely even in the face of engages I mean, we don't know fully appreciate the sequence of events, where sequencing of treatments for instance that will exist in the lymphoma space. We may find there was early data coming out in the other areas that by specific engages when delivered aggressively.
And two progression cause for instance, and exhaustion of T cell compartment overtime.
That may not bode well for an autologous car T cell therapy, and a off the shelf T cell therapy may be required for those patients.
We also know for instance that and we have seen as you know I mean, most of the patients we treated in our phase. One study are actually post car T cell therapy and.
And we certainly have looked at those patients with baseline six CD 19 expression and we've seen responses down lineup down lineup.
Patients that have been previously treated with car T cell therapy. So I continue to believe that.
A safe and effective off the shelf CD 19 targeted therapy, we will absolutely have its place.
And we need to understand what the potential for FTE 19 is in that context as well as inform the development of our platform and other product candidates. So definitely committed 2019.
And that in that understanding.
As it relates to <unk>.
Look our first commitment with <unk> with <unk> is to file an IND.
In the space of B cell lymphoma, and combined with Rituximab.
I do not believe we will need to wait for significant clinical data in oncology.
Move into autoimmunity.
And so from our perspective.
May be.
A pathway, where we treat a couple of patients established safety of the novel ADR receptor and its ability to function.
And then move into autoimmune.
Thank you well I think yes, I think I think there is just to finish I think there's a unique opportunity in autoimmunity with at <unk>.
<unk> <unk> two could provide three axes of attack.
Sensually against the pathogenesis, we can absolutely target CD 19 so.
Keep in mind five two because it has the CD 38 knockout can be combined with our two months in order to.
Target plasma cell.
And then.
Before him DB ADR technology is actually really unique when it when it comes to the potential for autoimmunity, because they can target it will target and they can actually eliminate.
Auto reactive T helper cells.
So we think there is potentially a really unique three pronged attack with the <unk> two product in autoimmunity.
Thank you one moment for our next question.
Our next question comes from Matthew Biegler with Oppenheimer. Your line is open.
Hey, guys.
Scott any plan on disclosing the remaining $5 96, and our 501 six data because I think you mentioned in the past that you thought the data were either compelling or competitive. So just kind of wanted to get your thoughts on that.
Yes, I mean, we.
We are going to work with the investigators of the study I think Theres I think theres desire.
On the part of these investigators to complete the study and essentially published the results I think as Ed alluded to we did make the decision to keep following patients in the $5 16, and 596 studies because we do have patients that are continuing in response and so yes I do think we earned at we internally at <unk>.
<unk> are not going to prioritize essentially the 516 and 596 sort of data wind up and then presentation, but we will absolutely work with investigators to enable that.
I think.
I think we will wait until all patients have reached the one year follow ups since we've committed to follow patients for one year to get a sense of durability of response.
Thank you I'm not showing any further questions at this time I'd like to turn the call back over to Scott <unk> for any closing remarks.
Thank you all for your participation in today's call B well.
Hello, Ladies and gentlemen, this does conclude today's presentation. You may now disconnect and have a wonderful day.
The conference will begin shortly to raise and lower Johan during Q&A, you can dial star one one.
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