Q4 2023 Fate Therapeutics Inc Earnings Call

Operator: Welcome to the Fate Therapeutics 4th Quarter 2023 Financial Results Conference Call. At this time, all participants are in a listen-only mode.

Welcome to the fate therapeutics fourth quarter 'twenty to 'twenty three financial results conference call. At this time, all participants are in a listen only mode.

Operator: This call is being webcast live on the Investors Section of Fate's website at fatetherapeutics.com. As a reminder, today's call is being recorded. I would now like to introduce Scott Washko, President and CEO of Fate Therapeutics. Thank you. Good afternoon, and thank you everyone for joining us for the Fate Therapeutics fourth quarter 2023 financial results. Shortly after 4 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-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.

This call is being webcast live on the investors section of States web website at fate Therapeutics dotcom.

As a reminder, today's call is being recorded.

Now I'd like to introduce Scott Washco, President and CEO of fate therapeutics.

Scott Washco: Thank you.

Scott Washco: Good afternoon, and thanks, everyone for joining us for the fate Therapeutics fourth quarter 2023 financial results call.

Scott Washco: 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.

Scott Washco: In addition, our Form 10-K for the year ended December 31, 2023 was filed shortly thereafter and.

Scott Washco: It can be found on the investors section of our website under financial information.

Scott Washko: 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 in 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.

Speaker Change: 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.

Speaker Change: These statements involve risks and uncertainties that can cause the actual results to differ materially from those in such forward looking statements.

Speaker Change: Please see the forward looking statement disclaimer on the company's earnings press release issued after the close of market today.

Speaker Change: 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.

Speaker Change: Except as required by law fate.

Speaker Change: Therapeutics disclaims any obligation to update these forward looking statements to reflect future information.

Speaker Change: <unk> or circumstances.

Scott Washko: Joining me on today's call are Ed Dulock, our Chief Financial Officer, and Dr. Bob Valimer, our Chief Research and Development Officer. During today's discussion, we will highlight the clinical milestones that we are poised to achieve in 2024 across our off-the-shelf, IPFC-derived CAR-NK cell and CAR-T cell programs. 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 investment in developing a deep pipeline of highly differentiated preclinical and clinical product candidates with the potential to bring significant therapeutic benefit to patients with cancer and autoimmune disease. Beginning with FT819, our off-the-shelf CD19-targeted CAR T-cell program, 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, CIRM's scientific working group unanimously scored our application as having exceptional merit.

Speaker Change: Joining me on todays call are Ed do Lark, our Chief Financial Officer, and Dr. Bob Palmer, Our Chief Research and development Officer.

Speaker Change: During today's discussion we will highlight clinical milestones that we are poised to achieve in 2024 across our off the shelf Ips derived car NK cell and car T cell programs.

Speaker Change: In addition, we will discuss our ongoing initiatives to continue the clinical expansion of our Ips C product platform into autoimmunity.

Speaker Change: Finally, we will review our financial position.

Speaker Change: Our operating discipline and strong cash balance have created the opportunity to continue our investment in developing a deep pipeline of highly differentiated preclinical and clinical product candidates with the potential to bring significant therapeutic benefit to patients with cancer and autoimmune diseases.

Speaker Change: Yes.

Speaker Change: Beginning with F T 819.

Our off the shelf CD 19 targeted car T cell program.

Speaker Change: 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 F. T 819 phase one clinical trial for the treatment of patients with moderate to.

Speaker Change: A severe SLE.

And its review of our application serves scientific working group unanimously score application as having exceptional merit.

Scott Washko: Notably, FT819 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 apheresis and without premature discontinuation of immunosuppressive therapy. We are currently conducting study startup activities at multiple U.S. clinical sites, with patient enrollment set to commence at the first dose level of 360 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 FT-819 administered following a standard three-day chemotherapy conditioning regimen. We plan to share initial clinical data from the study in 2024. We also continue to enroll patients in our FT-819 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.

Speaker Change: Notably F. T 819 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 pheresis and without premature discontinuation of immunosuppressive therapy.

Speaker Change: 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.

Speaker Change: Phase one study for the treatment of SLE is designed to evaluate safety.

Speaker Change: <unk> kinetics, and anti B cell activity of a single dose of FTA 19 administered following a standard three day chemotherapy conditioning regimen.

Speaker Change: And we plan to share initial clinical data from the study in 2024.

Speaker Change: We also continue to enroll patients in our F. T 19 phase one clinical trial for the treatment of relapsed refractory b cell lymphoma.

Speaker Change: This landmark study is the first ever clinical investigation of a T cell product candidates manufactured from a clonal master Ips cell line.

Scott Washko: 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 FT-819 Phase I 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-819 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 anti-tumor activity in heavily pre-treated 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 8 and 11, and deep suppression of CD19-positive B cells in the peripheral blood through day 30.

Speaker Change: We are currently enrolling patients in single dose treatment cohorts at 540 million cells and that 1 billion cells using a standard three day chemotherapy conditioning regimen.

Speaker Change: Clinical data previously presented by the company from the FTA 19 Phase one study in relapsed refractory B cell lymphoma showed a favorable safety profile and anti tumor activity.

Speaker Change: Of the first 11 patients treated with a single dose of FTA 19 add up to 360 million cells, we observed no dose limiting toxicities.

Speaker Change: No events of any grade of immune effector cell associated neurotoxicity syndrome, and mild cytokine release syndrome in only two patients.

Speaker Change: We observed anti tumor activity in heavily pretreated patients.

Speaker Change: <unk> three complete responses and.

Speaker Change: 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 CD 19 positive b cells in the peripheral blood through day.

Speaker Change: <unk> 30.

Speaker Change: At the American Society of Gene and cell therapy conference to be held in May we expect to share new data from our F. T 819 phase one clinical trial for the treatment of relapsed refractory B cell lymphoma at these higher dose cohorts as well as new clinical <unk>.

Scott Washko: We expect to share new data from our FT-819 Phase I clinical trial for the treatment of relapsed refractory B-cell lymphoma at these higher-dose cohorts, as well as new clinical translational data that support the potential clinical benefit of FT-819 for the treatment of B-cell mediated autoimmune disease, turning to our Solid Tumor Clinical Initiative. I am pleased to announce that under our collaboration with Ono Pharmaceutical, we have now initiated our phase one clinical trial of FT825 for the treatment of advanced solid tumor. Patient enrollment is currently ongoing at multiple clinical sites at the first dose level of 100 million cells. We believe FTA-25 represents an exciting new frontier in the field of cell-based cancer immunotherapy. The 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 tumor. These novel synthetic controls include a CXCR2 receptor to promote self-trafficking, a chimeric 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 trustees.

Speaker Change: Translational data that support the potential clinical benefit of.

Speaker Change: F T 819 for the treatment of B cell mediated autoimmune diseases.

Speaker Change: Turning to our solid tumor clinical initiatives.

Speaker Change: I am pleased to announce that under our collaboration with Ono pharmaceutical we have now initiated our phase one clinical trial of <unk> <unk> five for the treatment of advanced solid tumors.

Speaker Change: Patient enrollment is currently ongoing at multiple clinical sites at the first dose level of 100 million cells.

Speaker Change: We believe the FTA two five represents an exciting new frontier in the field of cell based cancer immunotherapy.

Speaker Change: The multiplexed engineered Ips derived car T cell program incorporates a constellation of anti tumor mechanisms that are designed to harness the potential of both our knee and adaptive immunity.

Speaker Change: And to overcome the unique challenges in treating solid tumors.

Speaker Change: These novel synthetic controls include a CX <unk> two receptor to promote cell trafficking.

Speaker Change: <unk> TGF beta receptor to redirect immuno suppressive signal in the tumor micro environment.

Speaker Change: A high affinity non cleavable CD 16 receptor to promote antibody dependent cellular cytotoxicity.

Speaker Change: And a novel cancer specific her two targeted antigen binding domain, which has exhibited unique and differentiated activity from that of Trastuzumab.

Scott Washko: In preclinical models, FTA-25 has shown similar potency with greater specificity toward HER2-expressing malignant cells compared to trastuzumab and has shown robust anti-tumor activity in vitro against HER2-low-expressing tumor cells. The FTA-25 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 where HER2-targeted therapies are approved as well as those where HER2-targeting has recently shown promising clinical activity, such as endometrial, ovarian, and cervical. The dose escalation scheme for the Phase 1 study includes two treatment regimens. Regimen A, or the monotherapy arm, consists of a standard three-day preconditioning regimen and a single dose of FTA-25 as monotherapy. Eligibility includes patients with advanced HER2-expressing somatemia.

Speaker Change: In preclinical models FTA two five has exhibited similar potency with greater specificity toward her two expressing malignant cells compared to Trastuzumab and has shown robust anti tumor activity in vitro against her two low expressing tumor.

Speaker Change: <unk> sells.

Speaker Change: The <unk> five phase one 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, where <unk> targeted therapies are approved as well as cancers, where.

Speaker Change: Her two targeting has recently shown promising clinical activity, such as endometrial ovarian and cervical cancers.

Speaker Change: The dose escalation schema for the Phase. One study includes two treatment regimens regimen, a or the monotherapy arm consists of a standard three day pre conditioning regimen and a single dose of <unk> hundred five as monotherapy.

Speaker Change: Eligibility includes patients with advanced her two expressing solid tumors.

Scott Washko: Regimen B, or the combination arm, consists of a standard three-day preconditioning regimen and a single dose of FTA-2-5 in combination with cetuximab, where we seek to additionally exploit innate immunity by leveraging the product candidate's 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 the regimen, turning to our NKCEL program. FT522 is our off-the-shelf CD19-targeted CAR-MS K-Cell program and is the first product candidate emerging from our IPFC product platform that incorporates our proprietary alloimmune defense receptor technology, which is designed to reduce or eliminate the need for the administration of intense chemotherapy conditioning to patients receiving cell therapy.

Speaker Change: Regimen D or the combination arm consists of a standard three day pre conditioning regimen and a single dose of <unk> five in combination with Cetuximab.

Speaker Change: We seek to additionally, exploit innate immunity by leveraging the product candidates high affinity non cleavable CD 16 receptor to target Egfr expressed on solid tumor cells.

Speaker Change: Roland <unk> regimen D will commence at the first dose level of 100 million cells upon clearance of dose limiting toxicities at this first dose level of regimen.

Speaker Change: Turning to our NK cell programs <unk> is our off the shelf CD 19 targeted car NK cell program and is the first product candidate emerging from our <unk> product platform that incorporates our proprietary allo immune defense receptor technology.

Speaker Change: <unk>.

Speaker Change: Which is designed to reduce or eliminate the need for administration of intense chemotherapy conditioning to patients receiving cell therapies.

Scott Washko: 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 therapy. However, conditioning chemotherapy induces toxicities, limits patient access, and prevents combinations with standard-of-care immunotherapies widely used in the community. FT522 incorporates a synthetic engineered receptor targeting 4-1BB expressed on allo-reactive immune cells. In preclinical studies, we have shown that the engagement of ADR-armed CAR-NK cells with alloreactive immune cells mitigated rejection, promoted NK cell proliferation, and increased anti-tumor activity.

Speaker Change: 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 induced toxicities limits patient.

Access and prevents combination with standard of care immunotherapy is widely used in the community based settings.

Speaker Change: F T. Five Q2 incorporates a synthetic engineered receptor targeting for one BB expressed on allo reactive immune cells.

Speaker Change: In preclinical studies, we have shown that the engagement of ADR armed car NK cells with allo reactive immune cells mitigated rejection.

Speaker Change: Promoted NK cell proliferation and increased anti tumor activity.

Scott Washko: These preclinical data suggest that 5-2-2 has the potential to drive clinical responses without the administration of intense conditioning chemotherapy to patients. Our ongoing multi-center phase one clinical trial of FT522 in patients with relapsed refractory B-cell lymphoma includes two regimens. Regimen A, or the conditioning arm, which consists of three days of standard conditioning chemotherapy, one dose of rituximab, and three doses of

Speaker Change: These preclinical data suggest that <unk> has the potential to drive clinical responses without administration of intense conditioning chemotherapy to patients.

Speaker Change: Our ongoing multi center phase one clinical trial of <unk> in patients with relapsed refractory B cell lymphoma includes two regimens regimen, a or the conditioning arm, which consists of three days of standard conditioning chemotherapy one dose of Rituxan.

Speaker Change: And three doses of <unk> two too.

Scott Washko: Regimen B, or the no conditioning arm, consists of one dose of rituximab and three doses of FT-5-2-2 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 B, or the no-conditioning arm, will commence at this first dose level of 300 million. Then, each regimen may proceed with dose escalation independently.

Speaker Change: Regimen D or the no conditioning arm consists of one dose of Rituximab.

Speaker Change: And three doses of <unk>, two too without conditioning chemotherapy.

Speaker Change: Enrollment into regimen, Ed is ongoing at the first dose level of 300 million cells per dose.

Speaker Change: And upon clearance of dose limiting toxicities at this first dose level and.

Speaker Change: Enrolment into regimen D or the no conditioning arm will commence at this first dose level of 300 million tons.

Speaker Change: Each regimen may proceed with dose escalation independently.

Scott Washko: We believe we have the opportunity to establish clinical proof of concept for our ADR technology and for our FT522 program without conditioning chemotherapy early in dose escalation. We will look to provide initial clinical data from our FT522 program in the second half of 2025. We also continue to enroll patients in our multi-center phase one clinical trial of FT576, our BCMA-targeted CAR and K-cell product candidate for the treatment of relapsed refractory multiple myeloma. The study is currently enrolling patients in three-dose treatment cohorts as monotherapy, as well as in combination with CD38-targeted monoclonal antibodies. Using a standard three-day chemotherapy conditioning regimen, the company has treated six patients at one billion cells per dose with no dose-limiting toxicities and no reports of any grade of CRS or IT.

Speaker Change: We believe we have the opportunity to establish clinical proof of concept for our ADR technology and for our Ft 502 program without conditioning chemotherapy.

Speaker Change: Early in dose escalation.

Speaker Change: We will look to provide initial clinical data from our ft. Five Q2 program in the second half of 2024.

Speaker Change: We also continue to enroll patients in our multi center phase one clinical trial of <unk> hundred 76.

Speaker Change: <unk> targeted car NK cell product candidate for the treatment of relapsed refractory multiple myeloma.

Speaker Change: The study is currently accruing patients in three dose treatment cohorts as monotherapy as well as in combination with CD 38 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.

Scott Washko: The study is currently enrolling patients at 2.5 billion cells per dose. Any further clinical development of FT576 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, where early clinical data with autologous CD19-targeted CAR T-cell therapy has shown profound clinical benefit. We believe there is a very strong value proposition for our iPSC product platform and off-the-shelf iPSC-derived cellular immunotherapies in autoimmunity. Where a relatively short-lived cell can deeply eradicate an aberrant B-cell population and enable rapid reconstitution of a healthy immune system, and where safety, patient convenience, and accessibility, cost, and scale will be key differentiating factors.

Speaker Change: This study is currently enrolling patients at 2.5 billion cells per dose.

Speaker Change: Any further clinical development of <unk> $5 76 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 <unk> targeted car T cell therapy has shown profound clinical benefit. We believe there is a very strong value.

Speaker Change: <unk> for our <unk> product platform and off the shelf Ips derived cellular immunotherapies in autoimmunity.

We're a relatively short lived sell can deeply eradicate an aberrant b cell population and enable rapid reconstitution of a healthy immune system and where safety patient convenience.

Speaker Change: And accessibility cost and scale will be key differentiating factors.

Scott Washko: We believe our FT-819 CAR T-cell program and our FT-522 CAR NK cell program have the potential to durably deplete a patient's pathogenic immune cells, drive immune reset, and meaningfully improve 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-819 and autoimmunity to include treatment of additional diseases beyond SLE. Additionally, we also plan to submit an investigational new drug application for FT522 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 autoimmunity. I would now like to turn the call over to Ed to review our financial results for the fourth quarter. Thank you, Fate Therapeutics is in a solid financial position to advance its 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.

Speaker Change: We believe our FTA 19 car T cell program.

<unk> two car NK cell program has the potential to durably deplete, our patients pathogenic immune cells drive immune reset.

Speaker Change: Meaningfully improve quality of life across a wide spectrum of autoimmune diseases.

Speaker Change: As we look forward into 2024, we expect to expand our clinical investigation of the FTA 19 in autoimmunity.

Speaker Change: To include treatment of additional diseases beyond SLE.

Speaker Change: Additionally, we also plan to submit an investigational new drug application for <unk> two in auto immunity, where we think the potential to reduce chemotherapy conditioning and to target and deplete b cells plasma cells and auto reactive T cells offers a highly differentiate.

Speaker Change: Good therapeutic profile across a broad range of autoimmune diseases.

Speaker Change: I would now like to turn the call over to Ed to review, our financial results for the fourth quarter.

Ed Lark: Thank you Scott and good afternoon.

Ed Lark: <unk> therapeutics is in a solid financial position to advance our pipeline our.

Ed Lark: Our cash cash equivalents and investments at the end of the fourth quarter were approximately $316 million.

Ed Lark: In the fourth quarter, our revenue declined to $1 7 million compared.

Ed Lark: Compared to $44 4 million for the same period last year.

Ed Dulock: 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, 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 expenses in the quarter in connection with our clinical development of FT825 with Ono. As a reminder, after opting into a co-development and co-commercialization arrangement for FT-825 in the U.S. and Europe with ONO in the fourth quarter of 2022, we account for that program's 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.

Ed Lark: 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 and solid tumors.

Ed Lark: Research and development expenses for the quarter decreased more than 60% from the same period last year to $31 8 million.

Ed Lark: The decline in our R&D expenses was attributable primarily to a decrease in salaries and benefits, including share based compensation expense following the companys restructuring in the first quarter of 2023.

Ed Lark: And from lower clinical trial costs, and lower demand for R&D materials and equipment.

Ed Lark: We also benefited from $2 million of Contra R&D expense in the quarter in connection with our clinical development of FTE <unk> five with Ono.

Ed Lark: As a reminder, after opting into a co development and co commercialization arrangement for FTA two five in the U S and Europe with Ono and the FERC fourth quarter of 2022, we account for that program's reimbursable expenses has been offset within our research and development costs.

Ed Lark: General and administrative expenses for the fourth quarter decreased by 17% from the same period last year to $17 9 million.

Ed Dulock: 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-819, we previously achieved the clinical milestone set forth in our amended license agreement with Memorial Sloan Kettering Cancer, 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 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 non-cash $645,000 non-operating loss associated with the change in fare value. Our net loss for the fourth quarter was $44.1 million, or $0.45 per share.

Ed Lark: The decline in our G&A expenses was attributable primarily to a decrease in salaries and benefits including share based compensation expense.

Ed Lark: Total operating expenses for the fourth quarter declined 54% from the same period last year to $49 $8 million, which.

Which includes $9 5 million in noncash share based compensation expense.

Ed Lark: Note that in connection with the development of our off the shelf Ips derived car T cell product candidate <unk> thousand 19, we previously achieved clinical milestone set forth in our amended license agreement with Memorial Sloan Kettering Cancer Center.

Ed Lark: Which triggered a first milestone payment to <unk> in 2021.

Ed Lark: Up to two additional milestone payments may be owed to Ms. Kay based on subsequent trading values of the company's common stock ranging from 100 to $150 per share.

Ed Lark: We assessed the fair value of these contingent milestone payments currently valued at $700000 on a quarterly basis.

In the fourth quarter, we recorded a non cash $645000 non operating loss associated with the change in fair value.

Ed Lark: Our net loss for the fourth quarter was $44 1 million or <unk> 45 per share.

Ed Dulock: 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 were able to respond to challenges. Advanced Key Clinical Programs, and Discover Next Generation Technology, and did so with efficiency; our full year gap 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.

Finally, and what could be considered a challenging year in 2023 for the company I wanted to recognize the resilience and collective efforts of our employees.

Ed Lark: Our cross functional teams were able to respond to challenges.

Ed Lark: Advanced key clinical programs and discover next generation technologies and did so with efficiency.

Ed Lark: Our full year GAAP operating expenses of $254 million compared favorably to our guidance range of $265 million to $285 million, enabling us to finish the year with more than $300 million on our balance sheet.

Operator: I would now like to open the call for questions. Thank you. As a reminder, to ask a question, you will need to press star 11 on your telephone if you've not already done so. To remove yourself from the queue, you may press star one one again.

Speaker Change: I would now like to open the call for questions.

Speaker Change: Thank you as a reminder to ask a question you will need to press star one on your telephone if you've not already to remove yourself from the queue. You May press Star. One again, we ask that you. Please limit yourself to one question and then re queue. Please.

Operator: We ask that you please limit yourself to one. Stand by while we compile the Q&A. Our first question comes from the line of Michael Yee of Jeff. Question, please, Mike. Hey guys, Good afternoon, and thank you for all the updates. I'm in your backyard in San Diego.

Speaker Change: By while we compile the Q&A roster.

Speaker Change: Okay.

Speaker Change: Our first question.

Speaker Change: From the line of Michael <unk>.

Jefferies. Your question please Michael.

Michael: Hey, guys. Good afternoon, and thank you for all the update.

Michael: I'm in your backyard in San Diego a quick question for you on 809 in your ongoing Lupus program can you.

Scott Washko: A quick question for you. With 819 and your ongoing lupus program, can you affirm 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, Scott, that those results should basically replicate autologous and how you expect or what you would expect there to differentiate? Thank you. So,

Michael: A firm whether youre 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.

Michael: Doubt in your mind start that those results showed a basically replicate autologous.

How you expect or what you would expect there to differentiate thank you.

Scott Washko: On the first point with respect to where exactly we are in this study, so we're working today with FT-819 in the loop of study with multiple different sites on Study Startup, 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 FT-819 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 819 and its 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 FT-819, we've seen a really clean safety profile We have seen what you would consider to be a traditional CAR T-cell expansion, where cells peak in the peripheral blood between days 8 and 11.

Michael: Sure.

Speaker Change: On the first on the first point with respect to where exactly are we in this study. So we are working today with <unk> 19 in 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.

Speaker Change: Just on interactions that we've had with multiple sites.

Speaker Change: As a company we are committed to providing a clinical update.

Speaker Change: With a with FCA 19 in lupus.

Speaker Change: While I certainly am not in the business of <unk>.

Predicting patient outcomes.

Before novel therapies, especially I think we are encouraged based on what we've seen with respect to <unk> hundred 19 and it's.

Speaker Change: Resemblance to autologous car T cell therapy at least with respect to how the product performs in patients from a translational perspective.

Speaker Change: As we've sort of highlighted in the past with FTA 19, we've seen a really clean safety profile.

Speaker Change: Through multiple dose levels we.

Speaker Change: We have seen what you would consider to be traditional <unk>.

Speaker Change: Car T cell expansion, where we've seen sales peak in the peripheral blood between days eight and 11, we have seen persistence of a single dose of FTA 19 stretching out.

Scott Washko: We have seen persistence of a single dose of FT-819 stretching out into the second and third week, day 15. And we've seen B-cell suppression that has extended out throughout the first 30-day cycle. So, with respect to how 819 is behaving in patients in vivo, we're really excited about that, and think we have the potential to replicate what's been seen in a relatively small number of patients with autologous CAR T-cell therapy. Thank you. Our next question comes from the line of, Any other questions, please? Oh, yeah.

Speaker Change: Into the second and third week day, 15, and we've seen.

Speaker Change: T cell depression suppression suppression suppression that has extended out throughout throughout the first 30 days cycle. So with respect to how 819th behaving in patients in vivo. We're really excited about that and think we have the potential to replicate what's been seen in a relatively.

Speaker Change: Small number of patients with autologous car T cell therapy.

Speaker Change: Thank you guys.

Speaker Change: Thank you.

Speaker Change: Our next question.

Speaker Change: Comes from the line of.

Citigroup: <unk> <unk> of Citigroup.

Citigroup: Question. Please you go.

Scott Washko: Hi Scott and team. Thank you for taking the question. What evidence do you have so far with respect to 819, not only clearing the plasma cells but also getting into the tissue component? www.

Citigroup: Oh, Yeah, Hi, Scott and team. Thank you for taking the question.

Citigroup: What evidence do you have so far with respect to 819.

unknown: Not only clearing the plasma cells, but also getting into the tissue component specifically the germinal centers, where there are tissue resident T cells that perhaps they need to be wiped out as well how did the how well do the ipsa's share there in terms of traffic trafficking into that component.

Scott Washko: Fatetherapeutics.com, They're there in terms of trafficking into that component. Yeah, I think, you know, while we can't necessarily speak to all secondary and tertiary tissues, I think it's important on this point to note that FT819 clearly has reached, based on responses that we've generated in the hematologic malignancy setting, specifically B cell lymphoma, we certainly have been So we've absolutely seen, just based on responses and CT scans, we've seen FT819 traffic out of the blood, reach tumor cells that are outside of the blood, and clear 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 FT819 is reaching all of the tissues that may be harboring bad-acting B Okay, thanks. And then the other question is sort of more strategic.

Speaker Change: Yes, I think while we can't necessarily speak to all secondary and tertiary tissues. I think it's important on this point to note that FTA 19.

Speaker Change: 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 CD 19 positive cancer cells. So we've absolutely seen just based on responses and <unk>.

Speaker Change: <unk>, we've seen FTA 19 traffic out of the blood reach tumor cells that are outside of the blood and clear pockets of CD 19 positive tumors and so based on that while we can't be certain that.

Speaker Change: Just on clinical data to date in oncology that FTA 19 is reaching some of these tissue. Some all of the tissues that may be harboring bad acting b cells, we are.

Speaker Change: Enthused by what we've seen any oncology, starting with <unk> ability to traffic outside of La blood annual reach secondary and tertiary tissue, where tumor cells have been located.

Speaker Change: Okay. Thanks, and then the other question is just sort of more strategic I believe the IMD for lupus has been open for about half a year, maybe maybe six or seven months.

Scott Washko: I believe the IND for Lupus has been open for about half a year, maybe six or seven months. And, as you know, it's obviously a highly competitive space. In fact, there was one other company that decided not to pursue their CD19 in SLE. I'm just wondering, you know, whether you're sticking with it. I'm just wondering to what extent you're going to look at other indications for 819 and whether you would accelerate those plans given the competitive nature of this Lupus space. Yeah, fair question.

Speaker Change: 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 CD 19.

Speaker Change: Sally.

Speaker Change: I'm just wondering.

Speaker Change: Picking with it I'm, just wondering to what extent youre going to look at other indications for <unk>.

Speaker Change: 19 and weather.

You would accelerate those those plans given given the competitive nature of this lupus space.

Scott Washko: I think one of the advantages that we have, compared to others, is that, keep in mind, we do have a study up and running, obviously, with FT-819 in oncology. So, we've been able to work successfully with several different oncology centers that are running FT-819 and partner, essentially, the oncologist with the rheumatologist to gain momentum for starting the study. So, we do think we're in a unique position, given that we have a tremendous amount of oncology experience with FT-819. We have relationships with key PIs on the oncology side, and that has enabled us to, I think, successfully partner with the rheumatologist.

Speaker Change: Yes.

Speaker Change: Fair question totally committed to <unk> 19 in autoimmunity I think one of the advantages that we have compared to others is that keep in mind. We did have we do have a study up and running obviously with FTA 19 in oncology. So we've been able to work successfully with <unk>.

Speaker Change: All different oncology centers that are running FTA 19, and partner essentially the oncologist with the rheumatologists to gain momentum in.

Speaker Change: 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 FTA 19, we have relationships with key pis on the oncology side and that has enabled us to I think successfully partner.

Speaker Change: With the Rheumatologists, we also keep in mind I mean, the one of the great things about an 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 thats already been manufactured.

Scott Washko: We also keep in mind, I mean, one of the great things about an off-the-shelf cell therapy is that we have product and inventory. And so 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 a very competitive space.

Speaker Change: And Ken rapidly begin to intervene and treat patients, which we're super excited about I think thirdly, absolutely acknowledging very competitive space.

Scott Washko: And as I said in my prepared remarks, I'm absolutely looking to expand the IND of 819 into additional indications in our. And just one more super quick on the dose for autoimmune disease. Is it, how did you pick the dose?

Speaker Change: And as I said in my prepared remarks.

Speaker Change: Absolutely looking to expand the <unk> 1982 additional indications in autoimmunity.

Speaker Change: And just one more super quick on the dose for autoimmune is it or how did you pick the dose is it where you're going with the same as the oncology or did you make any adjustments.

Scott Washko: Is it, are you going with the same as in oncology, or have you made any adjustments? So we start, we've gone through dose escalation, and one of the reasons we continue to do dose escalation on the oncology side is because we do think in the autoimmunity space, safety is absolutely going to be at a premium. At the time that we 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 FT-819, including reaching peaks of expansion that continue to increase with dose levels based on the safety profile that we've seen to date, which has been very clean. We're comfortable starting at 360 million cells. We clearly have the ability to continue to dose escalate in the autoimmunity study, as well as dose de-escalate, if that were necessary. Okay, thanks, Scott.

Speaker Change: So we start we've gone through dose escalation, which is one of the reasons. We continue to do a dose escalation on the oncology side is because we do think in the autoimmune space on safety is absolutely going to be at a premium.

Speaker Change: At the time that we had submitted the IND to the FDA, we had cleared 360 million cells.

Speaker Change: At that dose level in oncology.

Speaker Change: We have seen throughout the study in B cell lymphoma.

Speaker Change: Here's to be dose dependent expansion all of the <unk> FTA 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 we're comfortable starting at 360 million cells.

Speaker Change: We clearly have the ability to continue to dose escalate in the autoimmune in the autoimmune any study as well as dose escalate if that were necessary.

Speaker Change: Okay. Thanks, Scott.

Scott Washko: Sure. Thank you. Our next question comes from the line of Tara Bancroft of TD Comics. Go ahead. Hi, good afternoon guys. So I was wondering if you could tell us more about what it would take for you to choose.

Speaker Change: Sure.

Speaker Change: Thank you.

Speaker Change: Our next question.

Speaker Change: Comes from the line of.

Speaker Change: Tara Bancroft of TD Cowen. Please go ahead Tara.

Tara Bancroft: Hi, Good afternoon, guys. So I was wondering if you could tell us more about what it would take for you to choose.

Scott Washko: 819-522 for autoimmune disorders going forward or if you are planning on pursuing both, 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 522 is the fact that that cell has been engineered and includes ADR technology. I think while we're all excited about autoimmunity, the reality is that patients today in autoimmunity, at least to date, have all been treated with intense chemotherapy conditioning. I think we might all agree that that's probably not the right way to maximize the reach and treatment of patients with autoimmune diseases. And so one of the things we're really excited about 522 is understanding whether or not we can deliver, for instance, cell therapy without chemotherapy conditioning.

Tara Bancroft: One nine versus $5 <unk> for autoimmune disorder going forward or if you are planning on pursuing.

For the long term thanks.

Speaker Change: 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 $5. Two two is the fact that that cell has been engineered and includes ADR technology I think while we're all excited about autoimmunity.

Speaker Change: That is that patients today in autoimmunity at least to date to my knowledge have all been treated with intense chemotherapy conditioning.

Speaker Change: Get all agree that that's probably not the right way to maximize reach and treatment of patients with autoimmune diseases.

Speaker Change: And so one of the things we're really excited about is <unk> two is understanding whether or not we can deliver for instance in cell therapy without chemotherapy conditioning, I think that would be a significant.

Scott Washko: 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 without the conditioning. So 522; we're super excited about that and the ADR technology.

Speaker Change: Breakthrough in the field, especially in thinking about treating patients with autoimmune disease, essentially being able to decouple the requirement to administer intense chemotherapy conditioning to a patient.

Speaker Change: And being able to deliver a cell therapy that can be delivered off the shelf and could achieve the same level or similar levels of b cell reset.

Speaker Change: Without that conditioning, so $5 two were super excited about that and the ADR technology I think the other element that we're excited about with respect to <unk>. It's obviously, an NK cell on there are regimens.

Scott Washko: I think the other element that we're excited about with respect to 522, it's obviously an NK cell; there are regimens throughout autoimmunity where monoclonal antibodies are utilized. It's a CD19 targeted program. We have the potential to combine it with monoclonal antibody therapy, including monoclonal antibodies that have the ability to target 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 it's potentially very differentiating for 522. So we're excited about both products. All right, great.

Speaker Change: Our autoimmunity, where.

Speaker Change: A monoclonal antibodies are utilized.

Speaker Change: CD 19 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 more of a plasma cell so reaching into the early b cells through CD 19, as well as stretching into the plasma cell compartment potentially in <unk>.

Speaker Change: Nomination with a monoclonal antibody I think is potentially very differentiating for $5. Two two so we're excited about both product candidates.

Speaker Change: Alright, great. Thank you I agree Q2, Im sorry, thanks, guys. Thanks.

Scott Washko: Thank you. I agree. Thanks, guys.

Speaker Change: Thank you.

Speaker Change: Our next question.

Operator: Our next question... comes from the line of Tazeen Ahmad of Bank of America. Hi guys, thanks for taking my.., um, for more information. Thank you. Bye. For more information, visit www.fema.gov. What level of data are you there?

It comes from the line of <unk> Ahmad of Bank of America.

Ahmad: Hey, guys. Thanks for taking my questions.

Ahmad: Just some simple ones on timing.

Ahmad: And maybe just a little bit on bar for efficacy for 576 in multiple myeloma.

Ahmad: 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.

Scott Washko: Sure. Obviously, the multiple myeloma space is very crowded, and we've seen remarkable results with autologous programs. From our perspective, as we think about 576, I think 576 needs to have a therapeutic profile similar to what's been achieved with T cell engagers. So, we are talking about high response rates and certainly complete response rates that are significant. So, for us to continue the program with 576, I think it's really important that we see relatively high response rates, including complete response rates. The durability profile will obviously take time to play out, but that's how we're thinking about 576 currently.

Speaker Change: Sure. So obviously 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 576, I think 576 needs to have a therapeutic profile.

Speaker Change: Which is similar to what's been achieved with T cell engagement. So we are talking about high response rates.

Speaker Change: And certainly complete response rates.

That are significant so for us to continue the program with 576.

Speaker Change: I think it's really important that we see a relatively high response rates, including complete response rates durability will profile, we'll obviously take time to play out, but that's how we're thinking about 576 currently today.

Scott Washko: Just to give a little bit more of a bracket, what... Yeah, I think what we've seen with the T cell engagers is that the T cell engager response rates are probably north of 60% with respect to ORR and CR rates that are in the 40% Durability is obviously important too as T-cell engagers, like cell therapies, have seen longer-term progression for your survival that's certainly over a year. Thank you. I'm sorry. Did you see FG522?

Speaker Change: Okay, and just to give a little bit more of a bracket what type of response rates should we be thinking of in a range.

Speaker Change: Yeah, I think what we've seen with the T cell engagement is the T cell engages response rates are probably north of 60% with respect to <unk> and CR rates that are in the 40% range.

Speaker Change: Got it and then your ability obviously is important durability is obviously important to add T cell engaging <unk> like cell therapies have seen longer term progression free survival that certainly over a year.

Speaker Change: Okay, and then quickly when should we expect to see data for <unk> and.

Scott Washko: Yeah, FT522, I think we have the potential with 522 to show early proof of concept with the monotherapy arm, or, sorry, sorry, in the arm without conditioning chemotherapy. So the way the study works is the first three patients are treated with CyFlu. In the 522 study, this is at a dose of three times 300 million cells.

Speaker Change: In relapsed refractory <unk>.

Speaker Change: Okay.

Speaker Change: I'm, sorry did you say ft 522.

Speaker Change: Yeah.

Speaker Change: Yeah, <unk> I think we have the potential with $5 two to show early proof of concept with the.

Speaker Change: Monotherapy arm or sorry, sorry in the arm with our conditioning chemotherapy. So the way the study works as the first three patients are treated with Cy flew.

Speaker Change: In the <unk> study. This is at a dose of three times 300 million cells.

Scott Washko: As soon as we clear that dose, that dose level, two things can happen. We can dose escalate the CyFlu arm to three times 900 million cells. Importantly, though, we also opened the no conditioning arm.

Speaker Change: As soon as we clear that dose that dose level two things can happen, we can dose escalate the cy flew arm to three times 900 million cells.

Speaker Change: Importantly, though we also opened the no conditioning arm and so patient for 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 $5. Two two early clinical proof of concept with $5 two.

Scott Washko: And so patient four, for example, could be in the no conditioning arm, which would open it three times to 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 twenty. Will you say that we'll probably give an update as we progress with the study? Sure. Our next question comes from the line of Dinah Graybosh of LeRink Park.

Speaker Change: Without conditioning chemotherapy.

Speaker Change: We're looking to provide a data update in the second half of 'twenty four.

Speaker Change: And will you say that you've confirmed no DLT.

Speaker Change: The regimen a loader.

Speaker Change: You gave us the update.

Speaker Change: I think we'll probably give an update as we progress the study.

Speaker Change: Okay. Thank you.

Speaker Change: Sure.

Speaker Change: Thank you.

Speaker Change: Our next question comes from the line of China, Gray boss of Leerink partners.

Scott Washko: Hi, thanks for the question. I wanted, in the intent of understanding when you and probably others will have a more substantial number of lupus patients treated, one of you could talk through the challenges you faced in the 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 just enrolling these groups of studies difficult, or any challenges that you think are more of a study startup challenge that you already see them overcoming? And then maybe to sort of sum it up, like, when can we see a cohort of, say, 819 or 522 of something like 15 or 20 people?

China Gray: Hi, Thanks for the question.

China Gray: Yeah.

China Gray: And then kind of understanding when that new and probably others will have a more substantial number of treated patients what.

Wonder if you can talk through the challenges you faced in the last six months, specifically getting these sites up and running you already spoke about rheumatologists collaborating with oncologists.

China Gray: And are there any challenges that you expect to continue that will make its enrolling these lipid studies difficult or any challenges that you think are more of a steady startup challenging you already see them overcoming and then maybe to furniture summed it up like when can we see a cohort.

China Gray: 819, or 52 of something like 15 or 20 patients.

Scott Washko: Yeah, so look, I think all of us need to take a step back and recognize that most autoimmunity patients and most physicians that treat patients in the autoimmunity field are not familiar with self-therapy. So, as I mentioned, I think an advantage for us in study startup has been, although, you know, certainly there are challenges in, Bye, pioneering a brand-new field, and I mean that just generally for the community here that's advancing cell therapies. We're all pioneering a brand-new field in autoimmunity, and yeah, there will be challenges in study startup that we're all going to face and need to overcome. I think one of the advantages for us has been the fact that we are an oncology company.

Speaker Change: Yeah. So.

Speaker Change: 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 autoimmune field. There are not familiar with cell therapies. So I mentioned I think an advantage for us in study startup has been although certainly there are challenges.

Speaker Change: <unk>.

Speaker Change: Pioneering a brand new field and I mean that just generally for the community here, that's advancing cell therapies, where all pioneering a brand new field in autoimmunity and yes, there's going to be challenges and study startup that we're all going to face the need to overcome I think one of the advantages for US has been the fact that we are in encore.

Scott Washko: We do have good relationships with multiple centers and PIs that, on the oncology side, that have been conducting the 819 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.

<unk> company, we do have good relationships with multiple centers and pis that.

Speaker Change: On the oncology side that have been conducting the study and they have been advocates and ambassadors for us and partnering with their rheumatologist cohorts I think.

Speaker Change: Wow.

Speaker Change: 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 our only going to be able to go so fast in.

Scott Washko: So all of us, the reality is, are only going to be able to go so fast 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.

Speaker Change: In enrolling patients and that includes based on the way I think most of the protocols our structure in autoimmunity that involve 28 day patient staggers oftentimes so I think.

Speaker Change: 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 are well aware of.

Scott Washko: 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 concern 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, fully characterize all the integrity of the engineering. So, look, we're committed to providing an update on the 819 study in autoimmunity this year, but I think we're all going to have to We're all pioneering a brand new field. Maybe there will be one follow-up. Once you get a center up and running and have rheumatologists on board and ready to enroll patients, do the enrollment criteria set a new barrier for finding the right patient? Or how do you anticipate doing that?

Speaker Change: What's occurred recently with respect to the concern specifically around T cell malignancies.

Speaker Change: 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 Ips C fully characterize it and can understand exactly characterize fully characterize all the integrity of engineering, so look where can.

Speaker Change: Committed to providing an update on the 819 study in autoimmunity this year, but I think we're all going have to be patient as.

The field begins to take off where all pioneering a brand new field.

Speaker Change: Yeah, maybe one follow up once you get a center up and running and have rheumatology onboard and ready to enroll patients to the enrollment criteria do they set a new barrier for finding the right patients.

Speaker Change: And how do you anticipate doing that.

Scott Washko: I think the enrollment, look, unfortunately, I mean, we're talking about in many instances where these autoimmune diseases are pretty severe and have, you know, had devastating consequences on patients' lives. And so I do think there will be enrollment criteria once up and running. I think the enrollment criteria is supportive of enrolling patients. The brisk of it, sort of the pace of enrollment, though, to be clear, you know, is governed a bit by these 28-day staggers that are often mandated by the FDA. Okay, thanks, Scott. True.

Speaker Change: I think the enrollment look there are unfortunately, I mean, we're talking about in many instances, where these autoimmune diseases are pretty severe.

Speaker Change: And have.

Speaker Change: Have had devastating consequences on patients' lives and so I do think there is the enrollment criteria once up and running I think the enrollment criteria is supportive of enrolling patients.

Speaker Change: The brisk.

Speaker Change: The pace of enrollment, though to be clear is is governed a bit by these 28 day staggers that are often mandated by the FDA.

Speaker Change: Got it got it okay. Thanks Scott.

Speaker Change: Sure.

Scott Washko: Thank you. Our next question comes from the line of Mike Oles of Morgan Stanley. Your question, Mike.

Speaker Change: Thank you.

Speaker Change: Our next question.

Speaker Change: Our next question comes from the line of Michael <unk> of Morgan Stanley. Your question. Please Mike.

Scott Washko: Hey guys, thanks for taking the question. Maybe just to follow up on 522, Scott. You mentioned sharing the data potentially in the second half of this year. Curious if, All right, data at that time, and then maybe just secondly... Assuming ADR technology is validated, is that something you could easily add to 819, or... Yeah.

Michael: Hey, guys. Thanks for taking the question, maybe just a follow up on five to Scott. So you mentioned sharing the 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.

Speaker Change: And then maybe just secondly.

Speaker Change: Assuming no ADR technology is validated is that something you could easily add to $8 19 or are there notable challenges there. Thank you.

Scott Washko: Yeah, 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 side effects from flu 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.

Speaker Change: Sure Yes.

Scott Washco: Yes, the data update that we're looking to provide in the second half of 2024 would certainly include cohort of patients where cohorts of patients with <unk> conditioning.

Obviously, we think that is a significant milestone for the field of cell therapy being able to deliver a cell therapy and allow us to thrive without conditioning chemotherapy. So super excited about that pushing.

Scott Washko: 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 conditions. I think as we look at 522 and build ADR technology into our platform. While we have not spent a lot of time talking about it publicly, we have ADR technology embedded into multiple different IPS cell lines, including on the T-Cell. Thank you. Yeah. Thank you. Our next question... comes from the line of Peter Lawson of Barton.

Scott Washco: Pushing on that very hard and favoring app.

Scott Washco: Actually regimen D in terms of thinking about enrollment and the implications for that.

Scott Washco: As we think about our platform and how to reach patients without conditioning.

Scott Washco: I think as we look at $5 two two.

Scott Washco: Building ADR technology into our platform, while we have not spent a lot of time talking about it publicly we have ADR technology embedded into multiple different ips cell lines, including on the T cell side.

Speaker Change: Got it thank you.

Speaker Change: Yes.

Speaker Change: Thank you.

Speaker Change: Our next question.

Speaker Change: Comes from the line of Peter Lawson of Barclays.

Scott Washko: Thank you so much for the follow-up, www. Fatetherapeutics.com So with 5-2-2, I'm not going to get into the specific strategy that we're pursuing for the IND, but with respect to 5-2-2, we do think and are excited about a broader set of B-cell mediated autoimmune diseases that certainly could include SLE. We are not, by any means, ruling SLE out, but there's certainly a whole host of autoimmune diseases that are B-cell I suspect sitting here today that we're absolutely going to be very excited about exploring FT522 in a sort of broad set of potential indications. And I think, while 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 are multiple different conditioning regimens that we could look at. One of them may be CyFlu, given the precedent that exists, but there are certainly other regimens that we can think about adding on to that exist in autoimmunity.

Peter Lawson: Great. Thanks, so much just to follow up on Q2.

Peter Lawson: And autoimmune disorders.

Peter Lawson: His first deepwater autoimmune disorders that you're thinking about.

Speaker Change: Kudos include SME.

Speaker Change: And.

Speaker Change: Would you stop without conditioning with 52.

Speaker Change: So with 502 to not going to get into the specific strategy that we're pursuing for the IMD, but with respect to $5. Two two we do think and are excited about.

Speaker Change: A broader set of B cell mediated autoimmune diseases that certainly could include SLE are not we're not by any means ruling SLE out, but theres 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 in that we could potentially reaching cod.

Speaker Change: Nation with monoclonal antibody therapy.

Speaker Change: I suspect sitting here today.

Speaker Change: We are absolutely going to be very excited about exploring <unk> in its in a in a sort of a.

Speaker Change: Broad set of potential indications and I think.

Speaker Change: Well I think we will learn quite a bit from the oncology study. It won't surprise me if we filed the initial IMD where there is.

Speaker Change: Multiple different conditioning regimens that we could look at one of them may be psi fluid given the precedent that exist, but there are certainly other regimens that we can think about adding on to that existing auto immunity I think the real opportunity at the end of the day is to reach autoimmunity patients.

Scott Washko: I think the real opportunity, at the end of the day, is to reach autoimmunity patients, think about what regimens they're receiving today in their daily lives, and whether or not adding a cell therapy without CyFlu could substantially change their lives by promoting an immune response. Thank you. Thank you. Thank you, and I. I did. Yeah, Peter, we're not providing guidance today, but I think if you look back at the last two 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.

Speaker Change: Think about what regimens that are receiving today in their daily lives and whether or not adding a cell therapy without some flu could substantially changed their lives by promoting and immune reset.

Speaker Change: Okay. Thank you and then quick question for Ed just on kind of any guidance around SG&A and R&D.

Speaker Change: <unk>.

Ed Lark: Clients significantly year over year, just curious what the run rate is for 'twenty.

Ed Lark: 24.

Ed Lark: Yes, Peter we are not providing guidance today, but I think if you look back at the last two 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.

Ed Dulock: 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, 819 in oncology, 819 emerging in autoimmunity, 522, 825, across a couple of different indications. So, you know, 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 of both FT576 in myeloma and FT819 in oncology, and we'll have a go-no-good decision sometime later this year. So there may be some puts and takes to the extent that our data allows us to continue with later development. You know, we'll provide the appropriate guidance at that time, but for the time being, that $35 to $40 million per quarter is a reasonable run rate to assume in the first half of 2024.

Ed Lark: <unk> 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 819 in oncology 2019 emerging in autoimmunity $5 two to two five across a couple of different indications so the.

Ed Lark: 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 of both $55 76 in myeloma and FTE 19 in oncology and will have a go no go decision sometime later this year. So there may be some puts and takes to the extent our data allows us to continue related development.

Ed Lark: We'll 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.

Speaker Change: Great. Thanks, so much.

Ed Dulock: Thank you. Our next question comes from the line of Ben Burnett of Stiefel. Your question, please, Ben. Hi, good afternoon. This is Carolina Alvarez. I'm on for Bamboo Net.

Speaker Change: Thank you.

Speaker Change: Our next question.

Speaker Change: Comes from the line of Ben Burnett of Stifel. Your question. Please Ben.

Ben Burnett: Hi, Good afternoon. This is currently nylon is on for Matt. Thank you for taking our question.

Scott Washko: Thank you for taking our question. For 819 in autoimmune disease, there is this aspect 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 influenza depletion regimen may end up being required at least for 819 to ensure that a sufficient B cell depletion can occur? Yeah, based on the data that we've seen on the oncology side, I think we're very comfortable. And as you probably are aware, we've continued with the standard PsyFlu conditioning regimen that's been used in treating patients with autoimmunity, as well as the conditioning regimen that's used with autologous CAR-T cell therapy. And as I mentioned, based on the translational data that we have seen, we've seen FT-819 behave similarly to its autologous counterparts. We've seen dose-dependent expansion, and we've seen peaks in expansion that are similar to the autologous counterparts. We've seen persistence that's lasted for several weeks with respect to the product candidate.

Ben Burnett: 81, nine in autoimmune disease.

Thanks, Tom.

Speaker Change: Autoimmune disease patients have a stronger immune system in cancer patients.

Speaker Change: We can make dry for modern <unk> rejection of the allogeneic car T cells.

Speaker Change: To your perspective on the biggest income Morgan pantry depletion regimen may adopt BNP acquire at least 4819 to ensure that the sufficient b cell depletion kind of car.

Speaker Change: Yes based on the data that we've seen on the oncology side I think we're very comfortable and as you probably are aware we have continued with the standard psi fluid conditioning regimen, that's been used in treating patients with autoimmune city as well as the conditioning regimen, that's used with autologous car T cell therapy.

Speaker Change: Like I mentioned based on the trends that <unk> data that we have seen we've seen FTA 19 behaved similarly to their autologous counterparts, we've seen.

Speaker Change: Dose dependent expansion, we've seen peak and expansion that are similar to the or 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.

Scott Washko: 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 FT-819 in oncology. And I'm very excited about its potential in autoimmunity, where at least the data that exists in patients treated to date, primarily from the group in Germany, have suggested that a short-lived cell, in their case, an autologous program, but that an autologous cell is acting very rapidly. The kinetics of depletion are occurring quickly.

Speaker Change: Given all that I think we're really comfortable with the profile that we've seen with the FTA 19 on oncology and I'm very excited about its potential in autoimmunity, where at least the data that exists in patients treated to date, primarily out of the group in Germany has suggested that a short lived.

Speaker Change: Sell in their case, an autologous program, but that an autologous cell is acting very rapidly the kinetics of depletion, our kirker and quickly and that it is actually important at some level for the cell to ultimately clear the patient as opposed to being long lived so.

Scott Washko: 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 response. So, in the setting of autoimmunity, we believe, based on the autologous data that's been generated to date, that a short-lived cell can have profound impact, generate the necessary depletion, and enable a relatively rapid immune reset, and we're very excited about that. Understood, thank you.

Speaker Change: 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 that a short lived sell can have profound impact.

Speaker Change: Generate the necessary depletion unable a relatively rapid.

Speaker Change: Immune reset and we're very excited about that.

Okay understood. Thank you.

Scott Washko: Thank you. Our next question, above for our next question. Our next question comes from the line of Andrea Tan of Goldman Sachs. Your question, please, Andrea. Hi, this is Talani Usman on behalf of Andrea Tan.

Speaker Change: Thank you.

Speaker Change: Our next question.

Speaker Change: Please standby for our next question. Our next question comes from the line of Andrea <unk> of.

Speaker Change: Goldman Sachs. Your question please Andrea.

Speaker Change: Hi, This is Tony it's Matt on for Andrea and Thank you for taking our questions.

Scott Washko: Thank you for taking our questions. Firstly, could you please go through the considerations for FT-19 and B-cell malignancies, and then for 576 and multiple myeloma and the profile you're looking to see at higher doses to warrant further development relative to the autologous and allogeneic CAR T therapies? Yeah, I think I touched on that for multiple myeloma already. I think the profile for an allogeneic cell therapy where products are approved needs to be similar to the value proposition, the therapeutic value proposition that's provided by engagers. So on the lymphoma side, and as well as on the myeloma side, I think the appropriate benchmark is looking at the T cell engagers that are approved and being developed.

Matt: Could you please.

Matt: After the considerations for FTE 19 in B cell malignancies, and then for 576 in multiple myeloma in the profile, you're looking to see at the higher doses to warrant further development relative to the autologous and allogeneic car T therapies.

Speaker Change: Yes, I think I touched on that for multiple myeloma already I think the profile for an allogeneic cell therapy, where products are approved needs to be similar to the value proposition.

Speaker Change: <unk> value proposition, that's that's us provided by <unk>, so in lymphoma side and as well as in the myeloma side I think the appropriate benchmark is looking at the T cell engagements that are approved and being developed.

Speaker Change: Okay.

Scott Washko: And secondly, for FE522, just how do you think the results of that can show what you'd be willing to give up to achieve better safety and tolerability through the exclusion of the chemotherapy condition? I think I think that's something we're absolutely going to look at.

Speaker Change: Okay. Thank you and then secondly for Etsy.

Speaker Change: Jeff how are you thinking about.

Speaker Change: Yeah.

Jeff: See that you'd be willing to give up to achieve better safety and tolerability to the exclusion of the chemotherapy conditioning.

Jeff: I think I think that's something we're absolutely going to look at it I mean, I think there are a reality.

Scott Washko: 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 reached at 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 treatment of autoimmunity. Thank you. Our next question comes from the line of Yan'an Zhu of Wells Fargo Security: question, please. Great, thanks for taking our questions. The first thing I was wondering was,

Jeff: This is as we look at the autoimmune space.

Jeff: People can have an opinion on this but I don't think the vast majority of autoimmunity patients are going to be treated or reached.

Jeff: At specialized academic centers that treat oncology patients. So I think it is going to be absolutely critical in the field of autoimmunity.

Jeff: We reach patients where they live and breathe in the community.

Jeff: And that these patients are treated without intense chemotherapy conditioning.

Jeff: That's going to be critical for the autoimmune space.

Speaker Change: Thank you.

Speaker Change: Thank you.

Speaker Change: Our next question.

Speaker Change: Come from the line of.

Speaker Change: Youre non Xu.

Xu: Wells Fargo Securities Your question please.

Speaker Change: Great. Thanks for taking our questions.

Xu: First I was wondering.

Scott Washko: This is a follow-up to the earlier question about 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-derived T-cells could also travel to those additional tissues if there is such tissue? And my other question is about the patient population you plan to enroll in the SLE study. I'm wondering whether these will be patients refractory to biologics and other treatments, or could milder patients be enrolled as well? And lastly, I was just wondering if there are any competitive dynamics for patient enrollment, just given how many clinical trials will be ongoing at the same time in SLE. Do you think there could be some competition for enrolling patients?

Speaker Change: This is a follow up to the earlier question about tissue specificity.

Speaker Change: Was just wondering whether treating <unk> E would require the car T cells to traffic to additional tissues comparable is treating b cell malignancies, or do you have any thoughts on that and whether Ips CS.

Speaker Change: Derived T cells could also traffic to those additional tissue if there is FX tissue.

Speaker Change: Sure.

Speaker Change: My other question is about <unk>.

Speaker Change: About the patient population you plan to enroll in the <unk> study of wondering whether these will these will be patients refractory to.

Speaker Change: Biologics and other treatments or could milder patients be erode as well and lastly, I was just wondering if there any.

Speaker Change: Competitive dynamic for patient enrollment.

Speaker Change: Given how many clinical trials will be ongoing at the same time <unk> do you think it could be there could be some competition for enrolling patients. Thank you.

Scott Washko: Thank you. Yeah, so just let's start with the patients to be treated.

Speaker Change: Yes, so let's start with patients the patients to be treated yes. So these are patients with active.

Scott Washko: So these are patients with active SLE, moderate to severe disease, will have had to have multiple lines of therapy already. So I think the criteria of the patient that we're looking to enroll are similar to those that have been treated to date out of the group in Germany with the autologous counterparts. So this moderate to severe active disease, moderate to severe active disease, I think it's a competitive landscape. 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. For example, we don't have to leukophoresis a patient.

Speaker Change: Active SLE moderate to severe disease.

Speaker Change: We will have had to have multiple lines of therapy already so I think the criteria of patient that we're looking to enroll I think is similar to those that have been treated to date.

Speaker Change: Out of the group in Germany, with the autologous counterparts.

Speaker Change: This is moderate to severe active moderate to severe active disease I think.

Speaker Change: Certainly it's a competitive landscape there are.

Speaker Change: Over 10.

Speaker Change: Autologous car T cell programs that are beginning to move into autoimmune 80, 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.

Speaker Change: Don't have the leukapheresis or patient.

Scott Washko: Certainly, we don't have to take a patient prematurely off immunosuppressive therapy. We have a product that is in inventory and can rapidly sort of intervene and treat patients. As we begin to show, and continue to show safety and 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. Patients can be treated outpatient in an infusion center, and we can reach into the community.

Speaker Change: 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.

Speaker Change: As we begin to show continue to show safety and activity I think with our off the shelf program. There is the potential to reach patients outside of the academic medical centers more each of the community you've certainly seen us do that with NK cells, where our protocols do not require haas.

Speaker Change: <unk> can.

Speaker Change: Can be patients can be treated to 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 serve those patients.

Scott Washko: I think ultimately that will be a requirement to treat patients with autoimmunity and serve those patients well. And so we're excited about sort of the differentiated profile of an off-the-shelf cell therapy, including in direct comparison to their autologous counterparts, which I think provides some, you know, there are some real constraints on how an autologous cell can be delivered to patients today with autoimmunity, which is very helpful, and the question about whether SLE might involve additional tissue specificity. Yeah, so without a doubt, I think there are bad acting B cells that are sitting within secondary and tertiary tissue.

Speaker Change: And so we're excited about sort of the differentiation the differentiated profile of an off the shelf cell therapy, including in direct comparison to their autologous counterparts, which I think.

Speaker Change: Provide some theres some real constraints on how an autologous cell can be delivered to patients today with autoimmunity.

Speaker Change: Very helpful and a question about whether <unk> might involve additional tissue.

Speaker Change: For the sufficiency.

Speaker Change: Yeah, so without a doubt I think there are bad acting b cells that are sitting within the secondary and tertiary tissue I guess my comment on that I made comments about that earlier with respect to certainly we've seen from a clinical setting 819 reach tumor cells that are in these secondary tertiary tissues and deplete CD 19 <unk>.

Scott Washko: I guess my comment on that, I made comments on that earlier with respect to, certainly we've seen in a clinical setting, 819 rich 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 solid tumors. I got it.

Speaker Change: Positive tumor cells.

Speaker Change: I'd also note that we have done a significant amount of work with car NK versus car T cell pre clinically and we're very confident in essentially the homing in trafficking and infiltration potential of our T cell programs Ips derived car T cell programs and again thats been.

Speaker Change: Just on some significant models, we've done on the solid tumor side.

Scott Washko: Thanks for the answer. Sure. Thank you. Thank you. Our next question comes from the line of Gil Blum of Needham. Please go ahead. Hi, this is Ethan for Gil.

Speaker Change: Got it thanks for the answers.

Speaker Change: Sure.

Thank you.

Speaker Change: Sure.

Speaker Change: Our next question.

Speaker Change: From a line of Gil Blum of Needham <unk> Company. Please go ahead.

Speaker Change: Yeah, Hi, this is Ethan on for Joe. Thank you for taking our questions. Just wondering in your view if there are any clinical resolved flips and b cell lymphoma that would potentially gate FTE $5 22 for moving forward into autoimmune indications and then for second question I might have just.

Scott Washko: Thank you for taking our questions. I'm just wondering, in your view, if there are any clinical results, let's say in B-cell lymphoma, that would potentially gate FT522 for moving forward into an autoimmune indication? And then, for a second question, I might have just missed this, but are you still expecting to have data for FP576 and multiple myeloma in the first half of this year? Yeah, for 5.7.6, we'll give an update when we complete the dose cohort at 2.5 billion cells times three doses. And so we're looking at both regimen A as monotherapy and regimen B in combination with CD38 targeted MAD. When we complete that cohort with respect to responses, we'll give an update on the 1 billion cell cohort as well as the 2.5 billion cell cohort.

Speaker Change: I missed this but.

Speaker Change: Are you still expecting to have data for ft 576 in multiple myeloma in the first half of this year. Thank you.

Speaker Change: Yes for 576, 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 <unk> in combination with CD 38 targeted mad when we complete that cohort with respect to <unk>.

Speaker Change: Responses, we will give an update on the 1 billion cell cohort as well as the $2 5 billion cell cohort I suspect that'll be sometime in the middle of this year.

Scott Washko: I suspect that'll be sometime in the middle of this year, based on where we are currently in that study. As it relates to NK cells moving into autoimmunity, or FT522 specifically, I'm certainly excited by the potential for NK cells in autoimmunity. As I sort of mentioned before, we've seen, including with multidose 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.

Speaker Change: Just on where we are currently in that study as it relates to NK cells moving into autoimmunity or ft. Five two specifically.

Speaker Change: Certainly excited by the potential for NK cells in autoimmunity as I sort of mentioned before.

Speaker Change: 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 have been able to deliver NK cells in the outpatient setting in the community.

Scott Washko: And so I think that bodes very well for our potential to differentiate and reach patients with autoimmunity outside of the academic medical setting. Thank you. Thank you. I would now like to turn the conference back to Scott Walshko for closing.

Speaker Change: And so I think that bodes very well for our potential to differentiate and reach patients with our auto immunity outside of the academic medical centers.

Speaker Change: Thank you.

Speaker Change: Sure.

Speaker Change: Thank you I would now like to turn the conference back to Scott <unk> for closing remarks, Sir.

Scott Washko: Thank you. And thank you, everyone, for all your great questions today. Look forward to seeing you in the near future. Be well. This concludes today's conference call. Thank you for participating. You may, Thank you for watching!

Thank you and thank you everyone for all your great questions today look forward to seeing you in the near future.

Speaker Change: Yes.

Speaker Change: This concludes today's conference call. Thank you for participating you may have.

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