Q4 2023 Fate Therapeutics Inc Earnings Call
Participants
Edward Dulac; Chief Financial Officer; Fate Therapeutics Inc
Michael Yee; Analyst; Jefferies
Yigal Nochomovitz; Analyst; Citi
Tara Bancroft; Analyst; TD Cowen
Tazeen Ahmad; Analyst; Bank of America
Daina Graybosch; Analyst; Leerink Partners LLC
Mike Olsen; Analyst; Morgan Stanley
Peter Lawson; Analyst; Barclays
Yanan Zhu; Analyst; Wells Fargo Securities, LLC
Gil Blum; Analyst; Needham & Company Inc.
Presentation
Operator
Welcome to the Fate Therapeutics Fourth Quarter 2023 financial results conference call (Operator Instructions) This call is being webcast live on the Investors section of today's Web website at Fate Therapeutics.com. As a reminder, today's call is being recorded. I would now like to introduce Scott Watsco, President and CEO of Fate Therapeutics.
Thank you. Good afternoon, and thanks, everyone, for joining us for the Fate Therapeutics Fourth Quarter 2023 financial results call shortly after 4 PM 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. And in addition, our Form 10-K for the year ended December 31, 2023 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 1995.
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 well as the risk factors included in our Form 10-K for the year ended December 31, 2023 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, Fate Therapeutics disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.
Joining me on today's call are Edward Dulac, our Chief Financial Officer, and Dr. Bob Valameher, our Chief Research and Development Officer. During today's discussion, we will highlight clinical milestones that we are poised to achieve in 2024 across our off-the-shelf IPSC. derived CAR NK cell and CAR T cell program. In addition, we will discuss our ongoing initiatives to continue the clinical expansion of our IPSC. product platform into autoimmunity.
Finally, we will review our financial position where our operating discipline and strong cash balance have created the opportunity to continue our investments in developing a deep pipeline of highly differentiated pre-clinical and clinical product candidates with the potential to bring significant therapeutic benefit to patients with cancer and autoimmune diseases, beginning with FT. eight 19, our off-the-shelf CD19 targeted CAR T cell programs.
I am pleased to announce that the company has been awarded $7.9 million by the California Institute of Regenerative Medicine to support the conduct of our FT.819 Phase 1 clinical trial for the treatment of patients with moderate to severe SLE in its review of our application service scientific working group unanimously scored our application as having exceptional merits. Notably, FTA. 19 was recognized as offering a novel therapeutic approach for the treatment of SLE with its ready-to-use supply, which can be administered to patients without a recess and without premature discontinuation of immunosuppressive therapy.
We are currently conducting study start-up activities at multiple U.S. clinical sites with patient enrollment set to commence at the first dose level of 316 million cells. The Phase 1 study for the treatment of SLE is designed to evaluate safety, pharmacokinetics and anti B-cell activity of a single dose of FT819 administered following a standard three day chemotherapy conditioning regimen. And we plan to share initial clinical data from the study in 2024. We also continue to enroll patients in our FTA.
19 Phase 1 clinical trial for the treatment of relapsed refractory B-cell lymphoma. This landmark study is the first ever clinical investigation of a T cell product candidate manufactured from a clonal master IPSC. line. We are currently enrolling patients in single dose treatment cohorts at 540 million cells and at 1 billion cells using a standard three-day chemotherapy conditioning regimen, clinical data previously presented by the company from the FTA.
19 Phase 1 study in relapsed refractory B-cell lymphoma showed a favorable safety profile and antitumor activity of the first 11 patients treated with a single dose of FT. eight 19 at up to 360 million cells. We observed no dose-limiting toxicities, no events of any grade of immune effector cell associated neurotoxicity syndrome and mild cytokine release syndrome. In only two patients. We observed antitumor activity in heavily pretreated patients, including three complete responses.
And we observed translational data consistent with known T cell biology with CAR T cell expansion that peaked in the peripheral blood between days eight and 11 and deep suppression of CD19 positive B-cells in the peripheral blood through day 30 at the American Society of Gene and Cell Therapy Conference to be held in May. We expect to share new data from our FT819 Phase 1 clinical trial for the treatment of relapse refractory B-cell lymphoma at these higher dose cohorts as well as new clinical translational data that support the potential clinical benefit of FT819 for the treatment of B-cell mediated autoimmune diseases.
Turning to our solid tumor clinical initiatives, I am pleased to announce that under our collaboration with Ono Pharmaceutical, we have now initiated our Phase 1 clinical trial of FT. eight two five for the treatment of advanced solid tumors. Patient enrollment is currently ongoing at multiple clinical sites at the first dose level of 100 million cells.
We believe the FTA. two five represents an exciting new frontier in the field of cell-based cancer immunotherapy for multiplexed engineered IPS derived CAR T cell program incorporates a constellation of antitumor mechanisms that are designed to harness the potential of both innate and adaptive immunity and to overcome the unique challenges in treating solid tumors.
These novel synthetic controls include a CXCR2 receptor to promote cell trafficking, a Chimera TGF beta receptor to redirect immunosuppressive signals in the tumor microenvironment, a high-affinity non-cleavable CD16 receptor to promote antibody dependent cellular cytotoxicity and a novel cancer specific HER2 targeted antigen binding domain, which has exhibited unique and differentiated activity from that of trastuzumab.
In preclinical models, STA. to five has exhibited similar potency with greater specificity toward HER2 expressing malignant cells compared to trastuzumab and has shown robust antitumor activity in vitro against HER2 low expressing tumor cells. The FTHU. five Phase 1 study is designed to assess the safety, pharmacokinetics and activity as monotherapy and in combination with monoclonal antibody therapy in patients with advanced solid tumors, including cancers work, HER2 targeted therapies are approved as well as cancers where HER2 targeting has recently shown promising clinical activity such as endometrial, ovarian and cervical cancers.
The dose escalation schema for the Phase 1 study includes two treatment regimens, regimen, A. for the monotherapy arm consists of a standard three day preconditioning regimen and a single dose of FTL. two five as monotherapy.
Eligibility includes patients with advanced HER2 expressing solid tumors regimen B or the combination arm consists of a standard three day preconditioning regimen and a single dose of FTA. two five in combination with cetuximab where we seek to additionally exploit innate immunity by leveraging the product candidates, high-affinity non-cleavable CD16 receptor to target EGFR expressed on solid tumor cells. Enrollment into regimen B will commence at the first dose level of 100 million cells upon clearance of dose limiting toxicities at this first dose level of regimen.
Turning to our NK cell programs, FT. five two two is our off-the-shelf CD19 targeted CAR NK cell program and is the first product candidate emerging from our IPSC. product platform that incorporates our proprietary allo immune defense receptor technology, which is designed to reduce or eliminate the need for administration of intense chemotherapy conditioning to patients receiving cell therapies.
Today, conditioning patients with intense chemotherapy is a necessary component of the treatment course, for cell-based cancer immunotherapy, including for both autologous and allogeneic cell therapies, conditioning chemotherapy, induces toxicities limits, patient access and prevents combination with standard of care immunotherapies widely used in the community-based settings.
FT. five two two incorporates a synthetic engineered receptor targeting 4-1BB expressed on allo reactive immune cells. In preclinical studies, we have shown that the engagement of 80, our armed CAR-NK cells with allo reactive immune cells, mitigated rejection, promoted NK cell proliferation and increased anti-tumor activity. These preclinical data suggests that five to two has the potential to drive clinical responses without administration of intense conditioning chemotherapy to patients.
Our ongoing multi-center Phase 1 clinical trial of FT. five two two in patients with relapsed refractory B-cell lymphoma includes two regimens regimen A. for the conditioning arm, which consists of three days of standard conditioning chemotherapy, one dose of rituximab and three doses of FT. five to two regimen D for the no conditioning arm consists of one dose of rituximab and three doses of FT. five to two without conditioning chemotherapy.
Enrollment into regimen A. is ongoing at the first dose level of 300 million cells per dose and upon clearance of dose-limiting toxicities at this first dose level, enrollment into regimen D or the no conditioning arm will commence at this first dose level of 300 million. Each regimen may proceed with dose escalation independently. We believe we have the opportunity to establish clinical proof of concept for our ADR technology and for our FT. five two two program without conditioning chemotherapy.
Early in dose escalation, we will look to provide initial clinical data from our FT. five to two program in the second half of 2024. We also continue to enroll patients in our multi-center Phase 1 clinical trial of FT. five seven six, our BCMA targeted CAR NK cell product candidate for the treatment of relapse refractory multiple myeloma.
The study is currently accruing patients in three dose treatment cohorts as monotherapy as well as in combination with CD38 targeted monoclonal antibody using a standard three day chemotherapy conditioning regimen. The company has treated six patients at 1 billion cells per dose with no dose-limiting toxicities and no reports of any grade of CRS or I can't. The study is currently enrolling patients at 2.5 billion cells per dose and the further clinical development of FT. five seven six for the treatment of multiple myeloma will be determined by the company based on safety and activity at these higher dose levels.
As we advance these clinical programs, we remain committed to pursuing new therapeutic opportunities in autoimmunity or early clinical data with autologous CD19 targeted CAR T cell therapy has shown profound clinical benefit. We believe there is very strong value proposition for our IPSC. product platform and off the shelf IPSC. derived cellular immunotherapies in autoimmunity were relatively short-lived.
Cell can deeply eradicate an aberrant B-cell population and enable rapid reconstitution of a healthy immune system, and we're safety, patient, convenience and ease of accessibility. Cost and scale will be key differentiating factors.
We believe our FTA. 19 CAR T cell program and our FT. five to two CAR NK cell program have the potential to durably deplete a patient's pathogenic immune cells, drive immune reset and meaningfully improved quality of life across a wide spectrum of autoimmune diseases. As we look forward into 2024, we expect to expand our clinical investigation of FT. eight, 19 and autoimmunity to include treatment of additional diseases beyond SLE.
Additionally, we also plan to submit an investigational new drug application for FT. five two two in autoimmunity, where we think the potential to reduce chemotherapy conditioning and to target and deplete B-cells plasma cells and autoreactive T cells offers a highly differentiated therapeutic profile across a broad range of autoimmune diseases.
I would now like to turn the call over to Ed to review our financial results for the fourth quarter.
Edward Dulac
Thank you, Scott, and good afternoon. Fate Therapeutics is in a solid financial position to advance our pipeline. Our cash, cash equivalents and investments at the end of the fourth quarter were approximately $316 million. In the fourth quarter, our revenue declined to $1.7 million compared to $44.4 million for the same period last year.
As described previously, our revenue is now derived exclusively from our collaboration with Ono Pharmaceutical and specifically reflects research funding associated with the development of a second product candidate against an undisclosed target in solid tumors.
Research and development expenses for the quarter decreased more than 60% from the same period last year to $31.8 million. The decline in our R&D expenses was attributable primarily to a decrease in salaries and benefits, including share-based compensation expense following the company's restructuring in the first quarter of 2023 and from lower clinical trial costs and lower demand for R&D materials and equipment.
We also benefited from $2 million of contra R&D expense in the quarter in connection with our clinical development of FTA. two five with Ono. As a reminder, after opting into a co-development and co-commercialization arrangement for FT. eight to five in the US and Europe with ONO in the first fourth quarter of 2022.
We account for that PROGRAMS reimbursable expenses as an offset within our research and development costs. General and administrative expenses for the fourth quarter decreased by 17% from the same period last year to $17.9 million. The decline in our G&A expenses was attributable primarily to a decrease in salaries and benefits, including share-based compensation expense.
Total operating expenses for the fourth quarter declined 54% from the same period last year to $49.8 million, which includes $9.5 million in non-cash share-based compensation expense. Note that in connection with the development of our off-the-shelf IPSC. derived CAR T cell product candidate, FT. eight 19.
We previously achieved the clinical milestones set forth in our amended license agreement with Memorial Sloan Kettering Cancer Center, which triggered a first milestone payment to MSK in 2021, up to two additional milestone payments may be owed to MSK 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 $700,000 on a quarterly basis. In the fourth quarter, we recorded a noncash $645,000 non operating loss associated with the change in fair value. Our net loss for the fourth quarter was $44.1 million or $0.45 per share.
Finally, in what could be considered a challenging year in 2023 for the Company, I wanted to recognize the resilience and collective efforts of our employees. Our cross-functional teams are able to respond to challenges advanced key clinical programs and discover next-generation technologies and did so with efficiency. Our full year GAAP operating expenses of $254 million compared favorably to our guidance range of 265 to $285 million enabling us to finish the year with more than $300 million on our balance sheet.
I would now like to open the call for questions.
Question and Answer Session
Operator
Thank you (Operator Instructions) question comes from the line of Michael Yee of Jefferies.
Your question, please, Michael.
Michael Yee
Hey, guys, good afternoon and thank you for all the update. I'm in your backyard in San Diego. A quick question for you on eight one nine in your ongoing lupus program, can you confirm whether you're about to treat a patient will treat a patient and whether you would have data on some of those patients by the end of the year or around there? And is there any doubt in your mind start that those results should basically replicate autologous and how you expect or what you would expect there to differentiate.
Thank you, sir. On the first on the first point with respect to where exactly are we in this study, so we are working today with FT. eight, 19 and the lupus study with multiple different sites on start study start-up. And I think we are well positioned to treat the first patient in the coming weeks based on interactions that we've had with multiple sites as a company. We are committed to providing a clinical update with a with FDA 19 in lupus.
While I certainly am not in the business of predicting patient outcomes for novel therapies, especially, I think we are encouraged based on what we've seen with respect to eight 19, and it's a resemblance to autologous CAR T cell therapy at least with respect to how the product performs in patients from a translational perspective, as we've sort of highlighted in the past with FTA. 19.
We've seen a really clean safety profile through multiple dose levels. We have seen what you would consider to be our traditional CAR T cell expansion, where we've seen ourselves peak in the peripheral blood between days eight and 11. We have seen persistence of a single dose of FTHE. 19, stretching out on into the second and third week at day 15.
And we've seen our B-cell depression suppression depression suppression that has extended out throughout throughout the first 30 day cycle. So with respect to how eight nineteen's behaving in patients in vivo are really excited about that. And I think we have the potential to replicate what's been seen in a relatively small number of patients with autologous CAR T cell therapy.
Michael Yee
Thank you, guys.
Operator
Thank you.
Yigal Nochomovitz of Citigroup.
Yigal Nochomovitz
Oh, yes, hi, Scott and team. Thank you for taking the question on what evidence do you have so far with respect to eight 19 and not only clearing the plasma cells, but also getting into the tissue component, specifically the germinal centers where there are tissue resident B-cells that are they need to be wiped out as well on how to be how well do the IPSC.s they're there in terms of traffic trafficking into that component?
Yes. I think while we can't necessarily speak to all on secondary and tertiary tissues, I think it's important at this point to note that FT. eight, 19 clearly has reached based on the responses that we've generated in the hematologic malignancy setting, specifically B-cell lymphoma. We certainly have been able to reach tissues that are harboring, can't CD19 positive cancer cells.
So we've absolutely seen on just based on responses and CT scans, we've seen FTA. 19 traffic out of the blood reach tumor cells that are outside of the blood and clears pockets of CD19 positive tumors. And so based on that, while we can't be certain that based on clinical data to date in oncology, that FTA. 19 is reaching some of these tests on all of the tissues that may be harboring that acting B-cells.
We are enthused by what we've seen in the oncology, starting with FT. eight nineteen's ability to traffic outside of the blood and reach secondary and tertiary tissue where tumor cells have been located.
Yigal Nochomovitz
Okay, thanks. And then the other question is just sort of more strategic. I believe the I&D for lupus has been open for about half a year, maybe maybe six or seven months. And as you know, it's obviously a super competitive space. In fact, there was there was one other company that decided to not pursue their CD19 in SLE.
I'm just wondering just sticking with it, I'm just wondering what to what extent you're going to look at other indications for freight, 19 and weather and you would accelerate those those plans given given the competitive nature of this lupus space?
Yes, totally fair question totally committed to FGF19 in autoimmunity. I think one of the advantages that we have on compared to others is that keep in mind we did have we do have a study up and running, obviously with FT. 19 in oncology. So we've been able to work successfully with several different oncology centers that are running FT. eight, 19 and partner essentially the oncologists with the rheumatologist to gain momentum in studies in starting the study.
So we do think we are in a unique position given that we have a tremendous amount of oncology experience with FT. eight 19. We have relationships with key PI.s on the oncology side, and that has enabled us to, I think, successfully partner with rheumatologists. We also keep in mind, I mean, the one of the great things about our off-the-shelf cell therapy is that we have product in inventory.
And so we are once we get these studies up and running. We don't have manufacturing risk. We have product that's already been manufactured and can rapidly begin to intervene and treat patients, which we're super excited about. I think thirdly, absolutely acknowledging very competitive space. And as I said in my prepared remarks, I'm absolutely looking to expand the I&D of eight 19 into additional indications in autoimmunity.
Yigal Nochomovitz
And just one more super quick on the dose for autoimmune, is it how did you pick the dose? Is it going with the same as the oncology? Or did you make any adjustments?
So we start, we've gone through dose escalation and which one of the reasons we continue to do a dose escalation on the oncology side is because we do think in the autoimmunity space on safety is absolutely going to be at a premium. At the time that we had submitted the IND to the FDA. We had cleared 360 million cells at that dose level in oncology.
We have seen throughout the study in B-cell lymphoma, what appears to be dose-dependent expansion of the AFTA. 19, including reaching peaks of expansion that continue to increase with dose level based on the safety profile that we've seen to date, which has been very clean. And we're comfortable starting at 360 million cells. We clearly have the ability to continue to dose escalate in the autoimmunity, I mean, the autoimmunity study as well as dose de-escalate if that were necessary.
Yigal Nochomovitz
Thanks, Scott.
Sure.
Operator
Thank you. Tara Bancroft, TD Cowen.
Tara Bancroft
Hi, good afternoon, guys. I was wondering if you could tell us more about what it would take for you to at T. eight or nine versus five to two for autoimmune disorders going forward or if you are planning on pursuing both for the long term, thanks.
As best we sit here today. And as much as I can sort of speculate on the long term. I think we plan on pursuing both. I think one of the things we're really excited about with respect to five to two is the fact that that cell has been engineered and includes ADR technology. I think while we're all excited about autoimmunity. The reality that is that patients today in autoimmunity, at least to date, to my knowledge, have all been treated with intense chemotherapy conditioning.
I think we might all agree that that's probably not the right way to maximize reach and treatment of patients with autoimmune diseases. And so one of the things we're really excited about is five to two is understanding whether or not we can deliver, for instance, a cell therapy without chemotherapy conditioning.
I think that would be a significant breakthrough in the field, especially in thinking about treating patients with autoimmunity, essentially being able to decouple the requirement to administer intense chemotherapy conditioning to a patient and being able to deliver a cell therapy that could be delivered off the shelf and could achieve the same level or similar levels of B-cell reset and without the conditioning. So five to two, we're super excited about that.
And the ADR technology, I think the other element that we're excited about with respect to five to two, it's obviously an NK cell on there are regimens on throughout autoimmunity where a monoclonal antibodies are utilized. It's a CD19 targeted program.
We have the potential to combine with monoclonal antibody therapy, including monoclonal antibodies that have the ability to target more of a plasma cell, more of a plasma cell so reaching into the early B cells through CD19 as well as stretching into the plasma cell compartment, potentially in combination with a monoclonal antibody, I think is potentially very differentiating profile too. So we're excited about both product candidates.
Tara Bancroft
Okay, great. Thank you. And I agree five to two is very exciting. Thanks, Scott.
Operator
Tazeen Ahmad, Bank of America.
Tazeen Ahmad
Again, since we're taking my questions on just some simple ones on timing and maybe just a little bit on bar for efficacy. So for five, seven, six and multiple myeloma. What level of data are you expecting to generate and what level of efficacy should we be looking for there? And then I have a follow-up.
Sure. So obviously, while the multiple myeloma space is very crowded and we've seen remarkable results with the autologous programs, I think from our perspective, as we think about five seven six, I think five seven six needs to have a therapeutic profile, which is similar to what's been achieved with T-cell engagers. So we are talking about high response rates and certainly complete response rates on that are significant.
And so for us to continue the program with five seven six, I think it's really important that we see relatively high response rates and including complete response rates. The durability will profile will obviously take time to play out, but that's how we're thinking about five seven, six currently today.
Tazeen Ahmad
Okay. And just to give a little bit more of a bracket, what type of response rate should we be thinking of in a range?
Yes. I think what we've seen with the T cell engagers is the T cell engagers response rates are probably north of 60% with respect to ORR and CR rates that are in the 40% range.
Tazeen Ahmad
Okay. Got it.
And then durability, obviously, is important. Durability is obviously important to add T cell engagers like cell therapies have seen longer-term progression-free survival. That's certainly over a year.
Tazeen Ahmad
And then quickly, when should we expect to see data for STCT. two in relapsing MS?
I'm sorry, did you say FT. five to two?
Tazeen Ahmad
Yeah.
Yes, FT. five to two. I think we have the potential with five to two to show early proof of concept with the monotherapy arm or starting sorry, in the arm without conditioning chemotherapy. So the way the study works is the first three patients are treated with Zyflo in the five to two study. This is at a dose of 3 times 300 million cells.
As soon as we clear that dose that dose level two things can happen. We can dose escalate the site flu arm two to three times 900 million cells. Importantly, though, we also opened the no conditioning arm. And so patient four, for example, could be in the no conditioning arm that would open at three times 300 million cells. So we do believe that in short, order we have the potential to show proof of concept with five to two early clinical proof of concept with five to two without conditioning chemotherapy. And we're looking to provide a data update in the second half of '24.
Tazeen Ahmad
And will you say that you've confirmed no DLTs at a regimen, a low dose before you give us the update?
I think we'll probably give an update as we progress the study.
Tazeen Ahmad
Okay. Thank you.
Operator
Daina Graybosch of Leerink Partners.
Daina Graybosch
Thanks for the question. And the intent of understanding when you and probably others will have a more substantial number of Lucentis treated patients. Wonder if you can talk through the challenges you faced in this last six months specifically getting these sites up and running, you already spoke about rheumatologists, collaborating with oncologists.
And are there any challenges that you expect to continue that will make enrolling these lupus studies difficult or any challenges that you think are more of a study start-up challenge and you're already see them overcoming? And then maybe to sort of sum it up, like when can we see a cohorts and say of 8, 19 or five, Q2 have something like 15 or 20 patients?
Yes. So look, I think all of us need to take a step back and recognize, right. So most autoimmunity patients and most physicians that treat patients in the autoimmunity field or are not familiar with cell therapies. So as I mentioned, I think an advantage for us in study start-up has been, although certainly there are challenges in our pioneering a brand new field. And I mean, that's just generally for the community here. That's advancing cell therapies. We're all pioneering a brand new field in autoimmunity.
And yes, there's going to be challenges in study start-up on that. We're all going to face a need to overcome. I think one of the advantages for us has been the fact that we are an oncology company. We do have good relationships with multiple centers and PI.s that on the oncology side that have been conducting the A. 19 study and they have been advocates and ambassadors for us in partnering with their rheumatologist cohorts.
I think you know, while it's always prudent to be cautious. We are dealing with CAR T cell therapies. There are patient staggers that are mandated by the FDA. So all of us, the reality is are only going to be able to go so fast and in enrolling patients. And that includes based on the way, I think most of the protocols are structured in autoimmunity that involve 28 day patient staggers oftentimes. So I think, you know, we're all excited about the potential in autoimmunity. We're all moving forward at a brisk pace.
There are certainly at least with respect to autologous CAR T cell therapies, some safety concerns that have been raised generally in the field by the FDA. You're well aware of what's occurred recently with respect to the concerns specifically around T cell malignancies. We don't think on the IPS derived cell therapy side, we have that same risk profile that would come from an autologous program, given the fact that we engineer a single IPSC. fully characterize it and can understand exactly a character.
I fully characterize all the integrity of engineering. So look, we're committed to providing an update on the 19 study in autoimmunity this year. But I think we're all going to have to be patient as the field begins to take off oral pioneering a brand we feel.
Daina Graybosch
Can everyone follow up once you get a center up and running and have rheumatologists onboard and ready to enroll patients to the enrollment criteria? Do they set a new barrier for finding the right patients or how to and having them have to pay during?
I think the enrollment looked or unfortunately, I mean, we're talking about in many instances where these autoimmune diseases are pretty severe and have some have had devastating consequences on patients' lives. And so I do think there is the enrollment criteria. And once up and running, I think the enrollment criteria is supportive of enrolling patients, the risk of it, the sort of the pace of enrollment, though, to be clear, you know, is governed a bit by the 28 day staggers that are often mandated by the FDA.
Daina Graybosch
Got it. Okay. Thanks, Scott.
Operator
Mike Olsen of Morgan Stanley.
Mike Olsen
Your question, please, Mike, again, thanks for taking the question. But maybe just to follow-up on five to two, Scott. So you mentioned sharing that data potentially in the second half of this year. Just curious if you would expect to have Cohort B data at that time as well, which is without conditioning.
Then maybe just secondly, assuming your ADR technology is validated. Is that something you could easily add to eight 19? Are there notable challenges there? Thank you.
Sure. Yes, the data update that we're looking to provide in the second half of 2024 would certainly include a cohort of patients or cohorts of patients with no CyClean condition conditioning. Obviously, we think that is a significant milestone for the field of cell therapy, being able to deliver a cell therapy and allow it to thrive without conditioning chemotherapy.
So super excited about that. I'm pushing on that very hard and favoring actually regimen B in terms of thinking about enrollment and the implications for that as we think about our platform and how to reach patients without conditioning.
I think as we look at five to two building ADR technology into our platform. We have not spent a lot of time talking about it publicly. We add a DR. technology embedded into multiple different IPS cell lines, including on the T-cell side.
Mike Olsen
Got it. Thank you.
Yeah.
Operator
Peter Lawson, Barclays.
Peter Lawson
Great. Thank you so much. And just a follow-up on five to two in autoimmune disorders. Firstly, what autoimmune disorders are you thinking about, but that could also include SLE and would you start without conditioning five, two?
So with 5G two not going to get into the specific strategy that we're pursuing for the IND. But with respect to five to two, we do think and are excited about on a broader, a broader set of B cell-mediated autoimmune diseases that certainly could include SLE or not will not by any means rolling SLE out, but there's certainly a whole host of autoimmune diseases that are B-cell mediated, including autoimmune diseases, where the plasma cell compartment may play a more significant role and that we could potentially reach in combination with monoclonal antibody therapy.
I suspect sitting here today, we are absolutely going to be very excited about exploring FT. five G. two in its in a in a sort of a broad set of potential indications. And I think from what I said, I think we will learn quite a bit from the oncology study. It won't surprise me if we file the initial IND., where there is have multiple different conditioning regimens that we could look at.
One of them may be safely given the precedent that exists. But there are certainly other regimens that we can think about adding on to that existing autoimmunity. I think the real opportunity at the end of the day is to reach autoimmunity patients on think about what regimens they're receiving today in their daily lives and whether or not adding a cell therapy with outside flu could substantially change their lives by promoting an immune reset,.
Peter Lawson
Thank you. And a quick question, just on kind of any guidance around SG&A and R&D just considering declined significantly year over year, curious what the run rate is for the '24?
Edward Dulac
Yes. Peter, we're not providing guidance today, but I think if you look back at the last few quarters and I tend to want to look at this on a cash operating expense basis. But if you look at cash operating expenses in the third quarter, I think they were about $37 million, a very similar number, about $35 million in the fourth quarter. I think that's a reasonable baseline to carry into at least the first half of 2024.
And as the prepared remarks have indicated, we obviously have essentially five ongoing programs, eight, 19 in oncology, 19, emerging and autoimmunity five two two eight, two five across a couple of different indications. So the second half burn rate, I think is a good indicator of what at least the first half of 2024.
But as we have indicated, we are at the higher dose levels, both at two five, seven six and myeloma and FY19 in oncology, and we'll have a go no-go decision sometime later this year. So there may be some puts and takes on to extend our data allows us to continue related development will provide the appropriate guidance at that time. But for the time being that $35 million to $40 million per quarter is a reasonable run rate to assume in the first half of 2024.
Peter Lawson
Thanks much.
Operator
Thank you. Our next question comes from the line of Ben Burnett of Stifel. Your question please, Ben.
Hi, good afternoon. This is Caroline. I Vanessa on for Ben Burnett. Thank you for taking our question of our eight one nine in autoimmune disease. They do suspect that autoimmune disease patients have a stronger immune system than cancer patients, which may drive a more energetic rejection of the allogeneic CAR T cells. What's your perspective on this?
And do you think a more intense lymphodepletion regimen may end up being require at least for eight one nine to ensure that sufficient B-cell depletion can occur?
Yes. Based on the data that we've seen on the oncologist's office side, I think we're very comfortable. And as you probably are aware, we've continued with the standard side flu conditioning regimen that's been used in treating patients with autoimmunity as well as a conditioning regimen that's used with autologous CAR T cell therapy.
And like I mentioned, based on the translational data that we have seen, we've seen FTA. 19 behave similarly to their autologous counterparts, we've seen dose-dependent expansion. We've seen peaks and expansion that are similar to the autologous counterparts. We've seen persistence that's lasted for several weeks with respect to the product candidate, and we've seen B-cell suppression that extends out to at least 30 days.
So given all that, I think we're really comfortable with the profile that we've seen with FTA. 19 on oncology. And I'm very excited about its potential in autoimmunity, where it at least the data that exists in patients treated to date on primarily out of the Group in Germany has suggested that a short live cell in their case, an autologous program, but that an autologous cell is acting very rapidly.
The kinetics of depletion are co-occurring quickly. And that is actually important at some level for the cell to ultimately clear the patient as opposed to being long lived so that the B-cell compartment can come back and trigger the immune reset.
So in the setting of autoimmunity, we believe based on the autologous data that's been generated to date that are not that a short-lived cell can have profound impact on generate the necessary depletion, unable a relatively rapid immune reset, and we're very excited about that.
Understood. Thank you.
Operator
Andrea Tan, Goldman Sachs.
Hi, this is [Talani Smith] on for Andrew accounting for taking our questions. Firstly, could you please walk us through the considerations for FT. 19 in B-cell malignancies and then for five 76 and multiple myeloma and the profile you're looking to see at the higher doses to warrant further development relative to the autologous and allogeneic CAR-T therapies?
Yes, I think I touched on that for multiple myeloma already. I think that the profile for an allogeneic cell therapy where products are approved, needs to be similar to the value proposition, therapeutic value proposition that's provide that's us provided by engagers. So in lymphoma side, and as well as in the myeloma side, I think the appropriate benchmark is looking at the T cell engagers that are approved and being developed.
Thank you. And then secondly, for FY22, just how are you thinking about the development and efficacy that you'd be willing to give up to achieve better safety and tolerability through the exclusion of the chemotherapy conditioning?
I think I think that's something we're absolutely going to look at. I mean, I think the reality of this is as we look at the autoimmunity space, people can have an opinion on this, but I don't think the vast majority of autoimmunity patients are going to be treated or reach it specialized academic centers that treat oncology patients.
So I think it's going to be absolutely critical in the field of autoimmunity that we reach patients where they live and breathe in the community and that these patients are treated without intense chemotherapy conditioning, and I think that's going to be critical for the autoimmunity space.
Thank you.
Operator
Yanan Zhu, Wells Fargo Securities.
Yanan Zhu
Great. Thanks for taking our questions. The first, I was wondering, this is a follow-up to the earlier question about the tissue specificity. I was just wondering whether treating SLE. would require the CAR T cells to traffic to additional tissues compared with treating B-cell malignancies. Do you have any thoughts on that? And whether IPSC.s derived T cells could also traffic to those additional tissue if there is such tissue.
And my other question is about in low about the patient population. You plan to enroll in SLU. study of wondering whether this will these will be patients refractory to biologics and other treatments? Or could the milder patients be enrolled as well?
And lastly, I was just wondering if there are any competitive dynamic for patient enrollment, just given how many clinical trials will be ongoing at the same time, ASLE, do you think it could be there could be some competition for enrolling patients. Thank you.
Yes. So just let's start with patients. The patients to be treated. Yes. So these are patients with active SLE moderate to severe disease. It will have had to have multiple lines of therapy already. So I think the the criteria of patients that we're looking to enroll, I think, is similar to those that have been treated to date out of the Group in Germany with the autologous counterparts. So this moderate to severe activity are moderate to severe active disease.
I think certainly it's a competitive landscape and there are over 10 autologous CAR T cell programs that are beginning to move into autoimmunity, I think an off-the-shelf cell therapy program, even if at the same center as an autologous counterpart certainly has some unique and distinct advantages.
We don't have to Luca for each patient. Certainly we don't have to take a patient prematurely off immunosuppressive therapy. We have product that is in inventory and can rapidly sort of intervene and treat patients as we begin to show continuing to show safety and the activity. I think with our off-the-shelf program, there is the potential to reach patients outside of the academic medical centers more into the community.
You've certainly seen us do that with NK cells where our protocols do not require hospitalization can be patients can be treated as outpatient in an infusion center and we can reach into the community. I think ultimately, that will be a requirement to treat patients in autoimmunity and on serve those patients well.
And so we're excited about sort of the differentiation part, the differentiated profile of an off-the-shelf cell therapy, including in direct comparison to their autologous counterparts, which I think are some provide some there's some real constraints on how an autologous cell can be delivered to patients today with autoimmunity.
Yanan Zhu
Very helpful. And the question about whether SLE might involve additional tissue specificity?
Yes. So without a doubt, I think there are bad acting T-cells that are sitting within secondary and tertiary tissue I guess my comment on that and make comments about that earlier with respect to certainly we've seen from a clinical setting a 19 reach tumor cells that are in the secondary tertiary tissues and deplete CD19 positive tumor cells.
I'd also note that we've done a significant amount of work with CAR-NK versus CAR T cells preclinically, and we're very confident in essentially the homing and trafficking and infiltration potential of our T cell programs, IPS derived CAR T-cell programs. And again, that's based on some significant models we've done on the solid tumor side.
Yanan Zhu
Got it. Thanks for the answers. Thank you.
Operator
Our next question comes from the line of Gil Blum of Needham & Co. Please go ahead.
Gil Blum
Gil, thank you for taking our questions. I'm just wondering in your view, if there are any clinical results, let's say, in T-cell lymphoma that was potentially KFT. five, 22 from moving forward into autoimmune indications. And then for second question, I might have just missed this, but you still expecting to have data for FT. five 76 and multiple myeloma in the first half of this year? Thank you.
Yes, for five seven six, we'll give an update when we complete the dose cohort at 2.5 billion cell times three doses. And so we're looking at both regimen A. as a monotherapy and regimen B in combination with CD38 targeted mAb when we complete that cohorts with respect to responses we'll give an update on the 1 billion cell cohort as well as the 2.5 billion cell cohort.
I suspect that will be sometime in the middle of this year. And based on where we are currently in that study as it relates to NK cells moving into autoimmunity or FT. five to two specifically, certainly excited by the potential for NK cells in autoimmunity, as I sort of mentioned before, we've seen, including with multi-dose regimens, super clean safety profiles across our entire class of NK cell therapies, whether that be in hematologic malignancies or solid tumors.
We've been able to deliver NK cells in the outpatient setting in the community. And so I think that bodes very well for our potential to differentiate and reach patients with autoimmunity outside of the academic medicine.
Gil Blum
Thank you.
Operator
Thank you. I would now like to turn the conference back to Scott Wolcgko for closing remarks.
Thank you, and thank you, everyone, for all your great questions today and look forward to seeing you in the near future. You are.
Operator
And this concludes today's conference call. Thank you for participating.
