Q4 2021 Fate Therapeutics Inc Earnings Call

Welcome to defeat Therapeutics, Fourthquarter 2021 financial results Conference call.

Operator: to the Fate Therapeutics fourth quarter 2021 financial results conference call. At this time, all participants, journalists, and... This event is being webcast live.

At this time all participants are in a listen only mode.

This call is being webcast live.

Do investors section of feats website at fleet Therapeutics Dot com.

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

I would like to introduce caught Washco, President and C E O of feed therapeutics.

Thank you good afternoon, and thanks, everyone for joining us for the fate Therapeutics fourth quarter of 2021 financial results call <unk>.

Clark Walchko: Investor section of Fate's website at fatetherapeutics.com. As a reminder, today's call is being recorded. I would like to introduce Clark Walchko, President and CEO of... Thank you. Good afternoon, and thank you everyone for joining us for the Fate Therapeutics fourth quarter 2021 financial results call. Shortly after 4 pm Eastern Time today, we issued a press release with these results, which can be found on the investor section of our website under press release. In addition, our Form 10-K for the year ended December 31, 2021, was filed shortly thereafter and can be found on the Investors section of our website under Financial Information.

Shortly after four P M. Eastern time today, we issued a press release with these results, which can be found on the investors section of our website under press releases. In addition are Form 10-K for the year ended December 31, 2021 was filed shortly thereafter and can be found on the investors section.

Of our website under financial information.

Clark Walchko: Before we begin, I'd like to remind everyone that, except for statements of historical fact, 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.

Before we begin I'd 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 the.

These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward looking statements. Please see the forward looking statement disclaimer on the company's earnings press release issued after the close of market today.

Clark Walchko: 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, 2021, that was filed with the SEC. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, as 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.

As well as the risk factors included in our Form 10-K for the year ended December 31, 2021 that was filed with the SEC today.

Undue reliance should not be placed on forward looking statements, which speak only as of the date there made as facts and circumstances underlying these forward looking statements may change, except as required by law date therapeutics disclaims any obligation to update these forward looking statements to reflect future information events.

Or circumstances.

Joining me on today's call our Doctor Wayne Chew, our Chief Medical Officer, and do lock, our Chief Financial Officer, and Bob Ballmer, Our Chief Research and development Officer.

Clark Walchko: Joining me on today's call are Dr. Wayne Chu, our Chief Medical Officer, Ed Dulac, our Chief Financial Officer, and Bob Valamehr, our Chief Research and Development Officer. Today, we will highlight key clinical development initiatives that we are pursuing for our four disease franchises and certain milestones that we are seeking to achieve in 2022 with our off-the-shelf, IPSC-derived NK and T-cell programs for the treatment of cancer I would like to begin today by highlighting several development opportunities that we are aggressively pursuing with our off-the-shelf IPS-derived NK cell programs for patients with B-cell lymphoma.

Today, we will highlight key clinical development initiatives that we are pursuing for our for disease franchises and certain milestones that we are seeking to cheese in 2022 with our off the shelf Ips C derived N K and T cell programs for the treatment of cancer.

I would like to begin today by highlighting several development opportunities that we are aggressively pursuing with our off the shelf Ips arrived and K sell programs for patients with B cell lymphoma.

Clark Walchko: We are seeking to reach patients across the continuum of care and deliver transformative outcomes to heavily pre-treated patients being treated at specialized centers who have progressed on multiple lines of therapy, as well as to patients in the community who might benefit from earlier treatment with cell-based cancer immunotherapy. In particular, for those patients who have progressed on multiple lines of therapy, including autologous CD19-targeted CAR T-cell therapy, we believe our off-the-shelf IPS-derived and K-Cell programs have shown unique potential in addressing this area of critical unmet medical need.

We are seeking to reach patients across the continuum of care.

And deliver transformative the outcomes to heavily pre treated patients being treated at specialized centers, who have progressed on multiple lines of therapy.

As well as to patients in the community who might benefit from earlier treatment with cell based cancer immunotherapy.

In particular for those patients who have progressed on multiple lines of therapy, including autologous C. D 19 targeted car T cell therapy. We believe are off the shelf Ips derived in case of programs have shown unique potential in addressing this area of critical unmet.

Medical need.

Clark Walchko: While autologous CD19-targeted CAR T-cell therapy has led to remarkable improvements in patient outcomes, it is important to remember that about 30% of patients are primary refractory to CAR T-cell therapy, and the majority of responding patients will ultimately experience disease progression. There is no established standard of care for these patients, and unfortunately, outcomes with currently available therapies are dismal.

While autologous C. D 19 targeted car T cell therapy has led to remarkable improvements and patient outcomes. It is important to remember that about 30% of patients are primary refractory to car T cell therapy, and the majority of responding patients will hold.

<unk> experience disease progression.

There is no established standard of care for these patients and unfortunately outcomes with currently available therapies are dismal.

Clark Walchko: For example, according to a publication from the U.S. Lymphoma CAR T-Cell Consortium published in Blood in April of 2021, an analysis of physicians' choice of first-salvage therapy following CD19-targeted CAR T-cell therapy showed complete response rates ranging from only 12 to 20 percent, median progression-free survival ranging from 48 to 88 days, and median overall survival ranging from 3.5 to 11 months. Similar outcomes from additional retrospective studies were reported at the 2021 ASH Annual Meeting in December.

For example.

According to a publication from the U S lymphoma car T self consortium published in blood in April of 2021.

An analysis of physicians choice of first salvaged therapy. Following C. D 19 targeted car T cell therapy showed complete response rates ranging from only 12% to 20% <unk>.

A median progression free survival ranging from 48 to 88 days.

And median overall survival ranging from three five to 11 months.

Similar outcomes from additional retrospective studies were reported at the 2021 Ash annual meeting in December .

Clark Walchko: At ASH, we reported clinical responses from our FT-516 and FT-596 programs in patients previously treated with autologous CD19-targeted CAR T-cell therapy. 3 of 8 patients treated with FT516 and 5 of 8 patients treated with FT596 achieved a complete response at a minimum dose level of 90 million cells in combination with rituximab. In addition, we announced that our FT-516 program was granted Regenerative Medicine Advanced Therapy, or RMAT, designation by the FDA for relapsed refractory diffuse large B-cell lymphoma. RMAT designation is an FDA program designed to expedite the development and review of therapies that have demonstrated the potential to address an unmet medical need based on preliminary clinical evidence.

Add ash, we reported clinical responses from our F. T 516 in F. T 596 programs in patients previously treated with autologous C. D 19 targeted car T cell therapy.

Three of eight patients treated with F. T 516, and five of eight patients treated with F. T 596 achieved a complete response at a minimum dose level of 90 million cells in combination with Rituxan lab.

In addition, we announced that R. F. T 516 program was granted regenerative medicine advanced therapy or <unk> designation by the FDA for relapsed refractory diffuse large b cell lymphoma.

Aamac designation is an F. D. A program designed to expedite the development and reveal therapies that have demonstrated the potential to address and unmet medical need based on preliminary clinical evidence.

Clark Walchko: We believe we are well positioned to launch a pivotal study, whether that be with FT-516 or FT-596, by the end of 2022 for patients with aggressive lymphomas previously treated with autologous CD19-targeted CAR T-cell therapy, and that this development pathway represents a potential fast-to-market strategy. During the first half of 2022, we plan to engage the FDA to discuss CMC, manufacturing, and This timeline also coincides with the operational launch of our second GMP manufacturing facility, which is designed for pivotal and commercial production.

We believe we are well positioned to launch a pivotal study whether that be with FTE 516 or F. T 596 by the end of 2022 for patients with aggressive lymphomas previously treated with autologous CD 19 targeted car T cell therapy.

And that this development pathway represents a potential fast to market strategy.

During the first half of 2022, we planned to engage the FDA to discuss CMC manufacturing and pivotal study design in pursuit of this significant unmet medical need.

This timeline also coincides with the operational launch of our second GMP manufacturing facility, which is designed for pivotal in commercial production.

Clark Walchko: Recall that about 18 months ago, we began investing in the building of our second GMP manufacturing facility as we believe in-house manufacturing expertise and capabilities are critical to the successful development and commercialization of complex cell therapy. This 50,000 square foot facility remains on schedule to be operational by mid-2022.

Recall that about 18 months ago, we began investment in the building of our second GMP manufacturing facility as we believe in house manufacturing expertise and capabilities are critical to the successful development and commercialization of complex cell therapies.

This 50000 square foot facility remains on scheduled to be operational by mid 2022, we've.

Clark Walchko: We believe production of the pivotal and commercial drug product from this facility will allow us to most effectively fulfill CMC requirements that are necessary for pivotal trial conduct and BLA submission and to reduce the possibility of delays that other cell therapy companies have encountered in preparation for commercial launch. In addition to improving outcomes for heavily pre-treated patients who have progressed on multiple lines of therapy, we are also seeking to reach patients in the community setting who might benefit from earlier treatment with cell-based cancer immunotherapy.

We believe production of pivotal in commercial drug product from this facility will allow us to most effectively fulfilled CMC requirements that are necessary for pivotal trial conduct and BLA submission and to reduce the possibility of delays that other cell therapy companies have confronted in.

Preparation for commercial launch.

In addition to improving outcomes for heavily pre treated patients who have progressed on multiple lines of therapy. We're also seeking to reach patients in the community setting who might benefit from earlier treatment with cell based cancer immunotherapy.

Clark Walchko: To this end, we are actively working to bring FT-596 without Psi-flu conditioning chemotherapy into the community setting as an add-on to early-line standard-of-care rituximab-containing treatment regimens, based on the promising therapeutic profile that we observed with FT-596, including its substantially differentiated safety profile, supporting administration in the outpatient setting. And given that FT596 is specifically designed to synergize with monoclonal antibody therapy, it is an essential component of early line regimens for the treatment of B cell lymphoma. We are aggressively pursuing the addition of F-T-5962 R-Chomp as a dual antigen-targeting treatment approach in patients with newly diagnosed aggressive lymphoma.

To this and we are actively working to bring F. T 596, without Si flew conditioning chemotherapy.

Into the community setting as an add on to early line standard of care rituxan containing treatment regimens.

Based on the promising therapeutic profile that we observed with F. T 596 <unk>.

Including it substantially differentiated safety profile supporting administration in the outpatient setting and given that FTE 596 is specifically designed to synergize with monoclonal antibody therapy that is an essential component of early line regimens for the treatment of B cell lymphoma.

We are aggressively pursuing the addition of F T 5962 art shop.

A dual antigen targeting treatment approach and patients with newly diagnosed aggressive lymphomas.

Clark Walchko: In the coming weeks, we plan to submit a clinical protocol to the FDA that adds FT-596 to R-CHOP and expect to begin treating patients in the second half of 2022. We believe that demonstrating the ability to deliver off-the-shelf cell therapies in the community setting without CyFlu chemotherapy conditions, as an add-on to Frontline Immunotherapy Regimen, has the potential to transform outcomes for many patients with aggressive life-threatening At this time, we continue to enroll patients with relapsed refractory B-cell lymphoma in the dose escalation stage of our FT516 Phase 1 study and in the dose escalation stage of our FT596 Phase 1 study.

In the coming weeks, we plan to submit a clinical protocol to the FDA that adds F. T 596 to art shop, and expect to begin treating patients in the second half of 2022.

We believe that demonstrating the ability to deliver off the shelf cell therapies in the community setting without sigh flew chemotherapy conditioning.

As an add on to frontline immunotherapy regiments has the potential to trans form outcomes for many patients with aggressive life threatening disease.

At this time, we continue to enroll patients with relapsed refractory b cell lymphoma in the dose escalation stage of our FTE 516 phase one study and and the dose escalation stage of our F. T 596 phase one study.

Clark Walchko: With respect to FT516, we are enrolling patients into three disease-specific expansion cohorts, including patients with relapsed refractory B-cell lymphoma whose disease has progressed following autologous CD19-targeted CAR T-cell therapy. Third-line diffuse large B-cell lymphoma in patients that are naive to autologous CD19-targeted CAR T-cell therapy and third-line follicular lymphoma.

With respect to FTE 516, we are enrolling patients into three disease specific expansion cohorts, including patients with relapsed refractory b cell lymphoma, whose disease has progressed following autologous CD 19 targeted car T cell therapy.

Third line diffuse large b cell lymphoma in patients that are naive to autologous seating 19 targeted car T cell therapy.

<unk> third line Follicular lymphoma.

Clark Walchko: We're also enrolling patients into a fourth expansion cohort without PSY-Flu Conditioning Chemotherapy, adding FT-516 to the immunochemotherapy regimen of rituximab plus bendamustine. Importantly, in enrolling patients into these four-dose expansion cohorts, we are including sites that serve patients in the community setting. With respect to FT-596, having observed that a single-dose treatment schedule of FT-596 at 900 million cells was well-tolerated with no dose-limiting toxicities, we have increased the frequency of FT-596 dosing and initiated enrollment in a two-dose treatment schedule, with FT-596 administered on day 1 and day 15 at 900 million cells per dose, and with the potential to dose escalate to 1.8 billion cells per

We are also enrolling patients into a fourth expansion cohort without Si flew conditioning chemotherapy.

Adding FTE 516 to the immuno chemotherapy regimen of Rituxan Mab plus bendamustine.

Importantly, and enrolling patients to these four dose expansion cohorts, we are including sites that serve patients in the community setting.

With respect to FTE 596, having observed that a single dose treatment schedule of FTE 596 at 900 million cells was well tolerated with no dose limiting toxicities, we have increased the frequency of F. T 596, dosing and initiated enrollment of a two dose treat.

<unk> scheduled with F. T 596 administered on day, one and day 15 at 900 million cells per dose and with the potential to dose escalate to 1.8 billion cells per dose.

Clark Walchko: Similar to FT-516, we plan to initiate multiple disease-specific dose expansion cohorts for FT-596. We expect to provide a clinical and regulatory update from our FT-516 and FT-596 programs in the second half of 2022. I'd also like to take a moment to reiterate our excitement in conducting the first ever clinical trial of an iPSC-derived T cell therapy. FT-819 is the first-ever T-cell therapy manufactured from a clonal iPSC line to undergo clinical investigation.

Similar to FTE 516, we planned to initiate multiple disease specific dose expansion cohorts for <unk> 596, we expect to provide a clinical and regulatory update from our F. T 516 ft 596 programs in the second half of 2022.

I'd also like to take a moment to reiterate our excitement and conducting the first ever clinical trial of an IPSA derive T cell therapy.

FTA 19 is the first ever T cell therapy manufactured from a clonal IPSA line to undergo clinical investigation.

Clark Walchko: The Clonal Master IPSC Line 4F-T-819 is created from a single IPSC that has a novel CD19-targeted 1XX CAR construct integrated into the T-cell receptor alpha constant locus, ensuring complete biallelic disruption of T-cell receptor expression and promoting uniform CAR expression. We believe FT819 is highly differentiated from patient and donor-derived CAR T-cell therapy, both of which require the sourcing and engineering of large populations of immune cells and are fraught with batch-to-batch and cell-to-cell variability that can affect product quality, safety, efficacy, and patient reach. Instead, FT-819 is mass-produced, uniformly engineered, and homogeneous in composition.

The clonal Master IPSA line for FTA 19 is created from a single IPSA.

That has a novel CD 19 targeted one Xx car construct integrated into the T cell receptor alpha constant Lucas, ensuring complete biallelic disruption of T cell receptor expression and promoting uniform car expression.

We believe FTE 819 is highly differentiated from patient and donor derived car T cell therapies, both of which require the sourcing in engineering of large populations of immune cells and are fraught with batch to batch and sell to sell variability that can affect product quality.

Safety efficacy and patient reach.

Instead, FTA 19 is mass produced uniformly engineered and homogeneous and composition.

Clark Walchko: At ASH, we presented a poster demonstrating our capabilities relating to CGMP manufacturing of iPS-derived CAR T-cells, including our ability to produce up to 1 x 1013 FT819 cells in a single manufacturing campaign, with over 50% of FT819 cells exhibiting a memory T-cell phenotype. Today we are pleased to announce that the initial FT-819 dose escalation cohort at a single dose of 90 million cells cleared with no dose-limiting toxicities and no FT-819-related grade 3 or greater adverse events in patients with relapsed refractory DLDCL.

At Ash, we presented a poster demonstrating our capabilities relating to cgmp manufacturing of Ips drive car T cells, including our ability to produce up to one times 10 to the 13th FTA 19 cells and a single manufacturing campaign with over.

50% of FTE 819 cells exhibiting a memory T cell phenotype.

Today, we are pleased to announce that the initial FTA 19 dose escalation cohort at a single dose of 90 million cells cleared with no dose limiting toxicities and no FTA 19 related grade three or greater adverse events.

In patients with relapsed refractory D. L D C L.

Enrollment is now ongoing at five clinical sites in the U S. In three treatment regimens single dose cohort at 180 million cells single dose cohort at 90 million cells administered with low dose IL two sided coin support and three dose cohort at 30 million cells per dose.

Clark Walchko: Enrollment is now ongoing at five clinical sites in the U.S. in three treatment regimens, a single-dose cohort at 180 million cells, a single-dose cohort at 90 million cells administered with low-dose IL-2 cytokine support, and a three-dose cohort at 30 million cells per dose. In addition, enrollment is ongoing in the first single-dose escalation cohorts at 90 million cells for relapsed refractory chronic lymphocytic leukemia and for relapsed refractory acute lymphoblastic leukemia.

In addition, enrollment is ongoing and the first single dose escalation cohorts at 90 million cells firmly relapsed refractory chronic lymphocytic leukemia.

And for relapsed refractory acute lymphoblastic leukemia.

Turning to our multiple myeloma disease franchise.

Clark Walchko: Turning to our multiple myeloma disease franchise, I'm pleased to announce that the initial F-T-538 dose escalation cohort at three once-weekly doses of 100 million cells per dose in combination with the CD-38 targeted monoclonal antibody dark tube map has cleared with no dose limiting toxicity. Our FT538 product candidate is engineered with three functional components to optimize innate immunity, and preclinical studies have shown that FT538 exhibits enhanced serial killing, Antibody Dependent Cellular Cytotoxicity, and Functional Persistence. Compared to peripheral blooding,

I am pleased to announce that the initial FTE 538 dose escalation cohort at three once weekly doses of 100 million cells per dose in combination with the C. D 38 targeted monoclonal antibody dark <unk> has cleared with no dose limiting toxicities R. F T 530 <unk>.

Kennedy's engineered with three functional components to optimize innate immunity.

In the preclinical studies have shown that FTE 530 exhibits enhanced serial killing.

Antibody dependent cellular cytotoxicity and functional persistence compared to peripheral blood NK cells.

Clark Walchko: Enrollment in the FT538 Phase I study is now ongoing in the second multi-dose escalation cohort of 300 million cells per dose at eight U.S. sites. Similar to our approach in lymphoma, where we are developing FT-516 and FT-596. We have further modified our FT538 product candidate to create FT576, our off-the-shelf, iPSC-derived car and K-cell product candidate designed to target multiple antigens both through its high-avidity BCMA-targeted CAR and its high-affinity, non-cleavable CD16 FC receptor.

Enrollment in the FTE 538 Phase one study is now ongoing in the second multi dose escalation cohort of 300 million cells per dose at eight use sites.

Similar to our approach and lymphoma, where we are developing FTE $516 50 596.

We have further modified R. F. T 530 product candidate to create five F. T 576 hour off the shelf IPSA derived <unk> product candidate designed to target multiple antigens, both through its high avidity B CMA targeted car and it's high affinity non cleaver.

Double CD 16 FC receptor.

Clark Walchko: We have now treated the first patients in our Phase I study of FT576, which is designed to assess both single-dose and multi-dose treatment regimens as monotherapy, as well as in combination with Dar2Meb, an approach that uniquely enables targeting of both BCMA and CD38 antigens. We expect to provide a clinical update from our FT538 and FT576 programs in the second half of 2022. Turning to our AML disease franchise, enrollment is currently ongoing in two phase one studies of FT538 for patients with relapsed refractory AML.

We have now treated the first patients in our phase one study of FTE 576, which is designed to assess both single dose and multi dose treatment regimens as mono therapy as well as in combination with Dar two men.

An approach that uniquely enables targeting of both be CMA and CD 30 antigens, we expect to provide a clinical update from our FTE 538, and 55 706 programs in the second half of 2022.

Turning to our AML disease franchise enrollment is currently ongoing in two phase one studies of FTE 538 for patients with relapsed refractory AML.

Clark Walchko: The company's phase one study of FT538 as monotherapy is preparing to initiate enrollment in the third multi-dose escalation cohort of one billion cells per dose as monotherapy. This is noteworthy as it represents the highest dose of IPS-derived NK cell therapy tested to date with any of our products.

The companies Phase one study of F. T 538, as mono therapy is preparing to initiate enrollment in the third multi dose escalation cohort of 1 billion cells per dose as mono therapy.

This is noteworthy as it represents the highest dose of Ips derived NK cell therapy tested to date with any of our product continents. In addition in investigator initiated study of FTE 538 in combination with Dara <unk>, which is designed to enable recognition binding and killing of C. D 30.

Clark Walchko: In addition, an investigator-initiated study of FT538 in combination with daratumab, which is designed to enable recognition, binding, and killing of CD38 leukemic blasts through ADCC, is currently enrolling patients in the second multi-dose escalation cohort at 300 million cells per dose. We will look to provide an update on our AML franchise as we generate additional dose escalation data with FT538, including So we're able to fully compare the safety, anti-leukemic activity, and durability response of our FT516 and FT538 phase one studies.

Leukemic blasts through ADC is currently enrolling patients in the second multi dose escalation cohort at 300 million cells produce.

We will look to provide an update on our AML franchise as we generate additional dose escalation data with FTE 538, including in combination with Dar to map.

So are you able to fully compare the safety anti leukemic activity and durability response of RFT 516, and FTE 538 phase one studies.

Turning to our solid tumor franchise in November we shared phase one data from our FTE 500, and FTE 516 pilot programs and heavily pre treated patients who had received multiple lines of prior systemic therapy, including at least one line of checkpoint inhibitor therapy we.

Clark Walchko: Turning to our Solage Tumor franchise, in November, we shared phase one data from our FT 500 and FT 516 pilot programs in heavily pretreated patients who had received multiple lines of prior systemic therapy, including at least one line of checkpoint inhibitor therapy. We are very pleased with our clinical observations from these pilot programs, both of which demonstrated a favorable safety profile and feasibility of a multi-dose, multi-cycle treatment schedule with outpatient administration. In addition, both pilot programs showed clinical evidence of anti-tumor activity.

We're very pleased with are clinical observations from these pilot programs, both of which demonstrated a favorable safety profile and feasibility of a multi dose multi cycle treatment schedule with outpatient administration.

In both in addition, both pilot programs showed clinical evidence of the anti tumor activity.

Clark Walchko: With respect to FT500... Three of four non-small cell lung cancer patients treated in combination with checkpoint inhibitor therapy had a reduction in target lesion burden from baseline, including one partial response in a heavily pretreated patient who was refractory to two prior lines of checkpoint inhibitor therapy. And with respect to FT516, five of nine solid tumor patients treated in combination with anti-PD-L1, checkpoint inhibitor therapy, had a reduction in target lesion burden from baseline, including one partial response in a heavily pretreated patient with advanced melanoma who was refractory to two prior lines of checkpoint inhibitor therapy, on the heels of these pilot programs.

With respect to <unk> 500.

Three of four non small cell lung cancer patients treated in combination with checkpoint inhibitor therapy had reduction in target lesion burden from baseline, including one partial response and a heavily pre treated patient who was refractory to two prior lines of checkpoint inhibitor therapy.

And with respect to FTE 516, five of nine solid tumor patients treated in combination with anti PDL, one checkpoint inhibitor therapy had reduction in target lesion burden from baseline, including one partial response and a heavily pre treated patient with advanced melanoma, who was refractory to.

Two prior lines of checkpoint inhibitor therapy.

On the heels of these pilot programs, we are advancing a robust pipeline of five multiplex engineered Ips C derived and K and T cell product candidates for solid tumors.

Clark Walchko: We are advancing a robust pipeline of five multiplexed engineered, IPSC-derived, NK and T-cell product candidates for solid tumors. We believe our product candidates' novel mechanisms of attack and ability to synergize with therapies that are used early and often in care can drive significantly improved outcomes for patients with solid tumors. For example, with FT538, we are leveraging the ability of NK cells to recognize, bind, and kill antibody-coded tumor cells and the potential to deliver a fully optimized NK cell compartment to patients to maximize ADC. Building off of FT-538 as a foundation, we have created two additional wholly-owned product panels.

We believe our product candidates novel mechanisms of attack and ability to synergize with therapies that are used early and often and care can drive significantly improved outcomes for patients with solid tumors.

For example, with FTE 538, we are leveraging the ability of NK cells to recognise binding kill antibody coated tumor cells and the potential to deliver a fully optimized NK cell compartment to patients to maximize ADC.

Building also that T 538 is a foundation we have created two additional wholly owned product candidates.

Clark Walchko: FT536, which incorporates a CAR targeting the stress-induced proteins McA and McB and is designed to overcome prominent mechanisms of immune cell evasion, and FT573, which incorporates a CAR-targeting B7H3 and is designed to uniquely target the metabolic profile and metastasis of cancer. In addition, we are also developing multiplexed engineered CAR-NK and CAR-T cell product candidates for solid tumor I am pleased to announce that the first patients have been treated in our Phase I study to assess three once-weekly doses of FT538 in combination with monoclonal antibody therapy for advanced solid tumors.

<unk> 536, which incorporates a car targeting the stress induced proteins became mcbee and is designed to overcome prominent mechanisms of immune celebration.

<unk> F T 573, which incorporates a car targeting b 783, and is designed to uniquely target the medic varlet profile and metastasis of cancer.

In addition, we are also developing multiplexed engineered caryn K and car T cell product candidates for solid tumors alongside our two partners Jansen and Ono.

I am pleased to announce that the first patients have been treated in our phase one study to assess three once weekly doses of FTE 538 in combination with monoclonal antibody therapy for advanced solid tumors the clinical.

Clark Walchko: The clinical protocol includes combination with each of four monoclonal antibodies, EGFR targeted cetuximab, HER2 targeted trastuzumab, PD-1 targeted pembrolizumab, and PD-L1 targeted valium. Each patient is eligible to receive up to two FT538 treatment cycles, and additional FT538 treatment cycles may be administered to patients that achieve an initial clinical response. While the eligibility criteria enable the assessment of FT538 antibody combinations in a broad array of solid tumor indications, we are particularly interested in assessing various combinations in non-small cell lung cancer, given its immunological features, including that many tumor subsets express targets of interest for NK cell-based therapy.

Protocol includes combination with each of four monoclonal antibodies egfr targeted to talk some add her to targeted trastuzumab PD, one targeted pember lose ma'am and PDL one target avelumab each.

Each patient is eligible to receive up to two ft, $5 38 treatment cycles and additional FTE 538 treatment cycles may be administered to patients that achieve initial clinical response.

While the eligibility criteria enable the assessment of FTE 538 antibody combinations in a broad array of solid tumor indications, we are particularly interested in assessing various combinations in non small cell lung cancer, given its immunological features including that many tumor subsets express targets of.

<unk> for NK cell based therapy.

Clark Walchko: We're also preparing to initiate a multi-center phase one clinical trial to assess a multi-dose, multi-cycle treatment schedule of FT536, as monotherapy and in combination with Monoclonal Antibody Therapy for Advanced Solid Tumor. FT536 is the company's off-the-shelf, multiplexed-engineered, IPS-derived NK cell product candidate, which incorporates a novel CAR targeting the High expression of Mick A and Mick B Protein, which is induced by cellular stress, damage, or transformation, has been reported in many solid tumors.

We're also preparing to initiate a multi center phase one clinical trial to assess a multi dose multi cycle treatment schedule of FTE 536, as mono therapy and in combination with monoclonal antibody therapy for advanced solid tumors FTE 536 is the companies off the shelf.

Multiplexed engineered.

Yes derived encased sell product candidate, which incorporates a novel car targeting the proteins MC gay and mcbee.

Hi expression of mid game make the proteins, which is induced by cellular stress damage or transformation has been reported on many solid tumors, although the proto lytic shedding of the Alpha one in Alpha two domains of these proteins is recognized as a common.

Clark Walchko: Although the protolytic shedding of the alpha-1 and alpha-2 domains of these proteins is recognized as a common tumor escape mechanism, the Clonal Master iPSC Bank for FT536 was created from a single iPSC engineered with four functional elements, including the novel CAR which uniquely targets the alpha-3 domain of MYC-A-MYC-B and is designed to overcome tumor escape mechanisms mediated by loss of M We look forward to providing an initial update on our FT538 and FT536 solid tumor programs as we advance through dose escalation.

<unk> escape mechanism the.

The clonal Master IPSA Bank for FTE 536 was created from a single Itse engineered with four functional elements, including the novel car, which uniquely targets. The alpha three domain of MC a mcbee and is designed to overcome tumor escaped <unk>.

Isms mediated by loss of the MHC class, one expression and Proto lytic shedding we look forward to providing an initial update on our FTE 538, and FTE 536 solid tumor programs as we advance through dose escalation.

Clark Walchko: I would now like to turn the call over to Ed to highlight our fourth quarter financial results. Thank you, Scott, and good afternoon. Fate Therapeutics is in a strong financial position to advance our pipeline. Our cash, cash equivalents, and investments at the end of 2021 were approximately $717 million.

I would now like to turn the call over to Ed to highlight our fourth quarter financial results.

Thank you Scott and good afternoon.

Fate Therapeutics is in a strong financial position to advance our pipeline.

Our cash cash equivalents and investments at the end of 2021 for approximately $717 million.

Ed Dulac: In the fourth quarter of 2021, our collaboration revenue derived from our partnerships with Johnson and Ono Pharmaceutical increased by $1.2 million to $17.1 million, compared to $15.9 million for the same period last year. Research and development expenses for the fourth quarter increased by $30.5 million to $69.5 million, compared to $39 million for the same period last year. The increase in our R&D expenses was attributable primarily to investments made in equipment and materials.

In the fourth quarter of 2021, our collaboration revenue derived from our partnerships with Janssen pharmaceutical increased by $1.2 million to $17 $1 million compared to $15.9 million for the same period last year.

Research and development expenses for the fourth quarter increased by $35 million to $69.5 million compared to $39 million for the same period last year.

The increase in our R&D expenses was attributable primarily to investments made in equipment and materials increases an employee head count and compensation, including share based compensation and inexpensive associated with R&D fees and third party professional consultants.

Ed Dulac: In addition, increases in employee headcount and compensation, including share-based compensation, and in expenses associated with R&D fees and third-party professional consulting. General and administrative expenses for the fourth quarter of 2021 increased by $6.6 million to $16.9 million, compared to $10.3 million for the same period last year. The increase in our G&A expenses was attributable primarily to an increase in employee headcount and compensation, including share-based compensation, and Talent Acquisition and Facility-Related Fees. Total operating expenses for the fourth quarter were $86.4 million, which included $14.6 million in non-cash, share-based compensation expenses.

General and administrative expenses for the fourth quarter of 2021 increased by $6.6 million to $16 $9 million compared to $10.3 million for the same period last year.

The increase in our G&A expenses was attributable primarily to an increase in employee head count and compensation, including share based compensation and talent acquisition and facility related fees.

Total operating expenses for the fourth quarter for $86.4 million, which includes $14.6 million in non-cash share base compensation expense.

Note that in connection with the treatment of the first patient with our off the shelf hi, PFC derived car T cell product candidate FTE 819 in the third quarter of 2021, we achieved the clinical milestone set forth and are amended license agreement with Memorial Sloan Kettering Cancer Center.

Ed Dulac: Note that, in connection with the treatment of the first patient with our off-the-shelf, iPSC-derived CAR T-cell product candidate FT819 in the third quarter of 2021, we achieved the clinical milestone set forth in our amended license agreement with Memorial Sloan Kettering Cancer Center. This clinical milestone triggered a first milestone payment of $20 million to MSK, which we paid in the fourth quarter. Up to two additional milestone payments may be owed to MSK based on the subsequent trading values of the company's common stock, ranging from $100 to $150 per share.

<unk>.

This clinical milestone triggered a first milestone payment in the amount of $20 million to M. S K, which we paid in the fourth quarter.

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

Ed Dulac: We assess the fair value of these contingent milestone payments, currently valued at $24.2 million, on a quarterly basis. In the fourth quarter, we recorded a non-cash, $0.5 million non-operating benefit associated with the change in fair value. Our net loss for the fourth quarter of 2021 was $69.3 million, or $0.72 per share.

We assess the fair value of these contingent milestone payments currently valued at $24.2 million on a quarterly basis.

In the fourth quarter, we recorded a non-cash zero point $5 million non operating benefit associated with the change in fair value.

Our net loss for the fourth quarter of 2021 was $69.3 million or 72 cents per share.

Ed Dulac: And finally, we expect to end this year with at least $400 million in cash, cash equivalents, and investments. This does not include potential success-based milestone payments from our collaborations with Janssen and Ono Pharmaceuticals. With that, I would now like to open the call to questions. Thank you. At this time, to ask a question, please press star 1. Again, that is star one, SASAC. To withdraw your question, just press the pound key. Please stand by while we compile the case.

Finally, we expect to end this year with at least $400 million in cash cash equivalents and investments.

This does not include potential success based milestone payments from our collaborations with Jansen and Ono pharmaceutical.

And with that I would now like to open the call to questions.

Thank you at this time so that's a question. Please press star one on your telephone again that is star one to ask that question.

To a giant question just press the pound key.

Please stand that will be compiled a kidney roster.

Your first question comes from the line of Michael E from Jeffries Alliance and open.

Michael Yee: The first question comes from the line of Michael Yee from Jeff. Hey, Scott, thank you for the update. I appreciate that. We think that solid tumor updates later this year could obviously be pretty important as you expand the power of the platform. Could you just maybe comment on how to think about the ongoing 538 study in combination with antibodies and how to think about what that could show in terms of efficacy? And since you did comment that you're obviously now about to start the 536 MYC-AB study, would you have enough data later this year to talk about that in a solid tumor update? Thank you.

Hey, Scott. Thank you for the update I appreciate that.

We think that solid tumor updates ladies insured could obviously be pretty important as you expand the power of the platform could you just maybe comment on how to think about the ongoing.

38 studied in combination with antibodies and how to think about what that could show in terms of efficacy and since you did comment that you, but obviously now about to start the 536 <unk> study would you have enough data later this year to talk about that in a solid tumor okay. Thank you.

Sure. So I mean early in the 538 study, but obviously there are four different.

Clark Walchko: Sure, so, I mean, we're early in the 538 study, but obviously, there are four different escalation cohorts that are enrolling concurrently and independently. So we do believe we're gonna get a very good early look here with respect to FT538's potential in combination with four different monoclonal antibodies across several different solid tumors, but with an emphasis on non-small cell lung cancer. We can talk a little bit more about when we think that update will be, but we're striving to continue to work through dose escalation in the 538 study and then provide an update, which we think can be in the second half of this year.

Escalation cohorts that are enrolling concurrently and independently. So we do believe we're getting get a very good early look here with respect to FTE 538 potential in combination with four different monoclonal antibodies again across several different solid tumors, but with an emphasis on non small cell lung.

Cancer.

We thought we can talk a little bit more about when we think that updated will be but we're striving to continue to work through dose escalation in the 538 study and then provide an update which we think can be in the second half of this year. That's we're targeting currently with with dose escalation with F. T 536, the <unk>.

Clark Walchko: That's what we're targeting currently with dose escalation. With FT-536, the IND has obviously cleared with the FDA, and we're super excited about that. Another multiplexed engineered product that's pretty sophisticated. We cleared the IND in 30 days, and we expect to begin dosing the first patients in that study probably in the middle of this year. I think what's important about the 536 study is that, in addition to combination with monoclonal antibody, it includes a monotherapy arm.

He has obviously cleared with the FDA Super excited about that another multiplexed engineered product that's pretty sophisticated that we cleared the Indy in 30 days and we expect to begin dosing the first patients in that study in.

In the come in probably in the middle of this year I think what's important about the 536 study is it all in addition to combination with monoclonal antibody. It includes a mono therapy or.

Clark Walchko: And so the monotherapy arm will kick off first. We'll start with 100 million cells. We'll start at multiple doses of that monotherapy arm. So we think this will be an interesting first look at the CAR-MIC-A and MIC-B construct and its ability to target certain solid cells.

And so the mono therapy arm will kick off first.

We will start at 100 million cells will start up multiple doses of that mono therapy arm. So we think this will be an interesting first look at the car MC a Nick B.

Construct and its ability to target certain solid tumors.

Clark Walchko: So, you know, we're relatively early with respect to the development of the solid tumor franchise, but we look to provide an update as we work through dose escalation. Thank you. Your next question comes to the line of Yigal Nochomovitz. Hi, this is Ashiq Mubarak. I'm from Yigal.

So.

We're we're relatively early with respect to the development of a solid tumor franchise, but look for look to provide an update as we work through dose escalation.

Thank you.

Your next question comes from the line a few golf a trauma fits from city your lifestyle open.

Oh, Hi, this is the Arctic Mubarak on for your golf. Thanks for taking my questions and the for the post City 19, Carty expansion study the chair initiating in visa lymphomas. Later this year I guess what are some of the key factors, you're considering and choosing between 516 and five.

Ashiq Mubarak: Thanks for taking my questions. For the post-CD19 CAR-T expansion study that you're initiating in B-cell lymphomas later this year, what are some of the key factors you're considering in choosing between 516 and 596? Yeah, there's a multitude of factors that will come into play. I think the two that I would highlight are, number one, we're obviously continuing to generate data with both FT-516 as well as FT-596. So we'll certainly make a data-driven decision.

<unk>.

Yes, there is a multitude of factors that will come into play I think the two that I would highlight is number one more obviously continuing to generate data with both the F. T 516, as well as FTE 596. So we'll make we will certainly make a data driven decision. We're also having conversations with the FDA with respect to clinical study.

Ashiq Mubarak: We're also having conversations with the FDA with respect to clinical study design for that. So, you know, input from the FDA will also impact our decision with respect to which product candidate we'll ultimately select. I think the one thing to note is certainly FT-596; we're doing a little bit more work with respect to its dose and schedule. And we've indicated that we potentially will do a little bit of dose escalation work still with FT-596 and go to 1.8 billion cells. We think that's prudent and makes absolute sense.

Design for that so input from the FDA will also impact our decision with respect to what product candidate will ultimately select I think the one thing to note is certainly FTE 596, we're doing a little bit more work with respect to its dose and schedule.

And we've indicated that we potentially will even do a little bit of dose escalation work still with FTE 596, and go to 1.8 billion cells. We think that's prudent makes absolute sense.

Clark Walchko: I think, you know, we will make the decision ultimately probably in the second half of the year based on a multitude of factors. We are prepared to move forward with either product. Okay, thank you very much. Sure. Thank you very much. Our next question comes on the line from Tyler Van Buren from Cowen. Hi guys, this is Tara on behalf of Tyler.

As I.

I think we will make.

Make the decision ultimately probably in the second half of the year based on a multitude of factors will be pripet, we are prepared to move forward with either product Canada.

Okay. Thank you very much.

Sure.

Your next question comes from the lamp, Tyler Vanburen from talent and your lifestyle.

Hi, guys. This is tara on for Tyler.

Tara Bancroft: So I want to focus on the Benda-Muskin combo that you're currently enrolling in for 5.1.6 and the RCHOP course for 5.9.6, which haven't been talked about too much yet. So first, What proportion of patients are being treated in the community, sending at least Ashiq Mubarak, Tara Bancroft, Edward Dulac, Ashiq Mubarak, Tazeen Ahmad, Yanan Zhu, Mara? So how many patients and where can we set expectations? Yeah, so I think in future updates, we'll provide clarity on when we might be able to provide data on both 516 and Benda, as well as 596, obviously in combination with our shop, but I'll let Wayne talk about our strategy a little bit with 516 and 596 and our outreach into the community.

Wanted to focus on the Uhm Bendamustine combo that you're currently enrolling for 516 and and the Orange shop cards for 596, which hasn't been talked about two months yet so first.

What proportion of patients are being treated in the community sending at least.

Setting at least for that Bender cohort and uhm when can we expect data from that set it come along with the longer term phase one data in August or at Ash and.

So how many patients and where can we set expectations. Thanks.

Yeah. So I think it in future updates will provide clarity on when we might be able to provide data on both 516 are bender.

As well as 596, obviously in combining with our shop, but I'll I'll, let Wayne talk about our strategy, a little bit with 516, and 596 and our outreach into the community.

So.

Tara Bancroft: Sure, so when we think about these combinations of 516 and 596, you know, as Scott mentioned, we're highly interested in the ability to use these cell products without flu-sized conditioning. And so the rationale for combinations with R-BENDA and then R-CHOP is essentially twofold.

When we think about these.

These combinations of $505 six as.

Scott mentioned were highly interested in the ability to.

To use the cell products.

Without flew side conditioning, and so the rationale for combinations with our bend and then our chop are essentially twofold. One is just to take a standard.

Clark Walchko: One is to take a standard immunochemotherapy regimen that's used for the treatment of lymphoma and see whether or not having complementary mechanisms of action can translate into greater clinical benefit. The second question is really about the ability of regimens such as R-BENDA or R-CHOP to also serve themselves as conditioning regimens that can facilitate 516 or 596 pharmacokinetics. And so the purpose of doing both of these investigations is really to hone in on those two different concepts.

You mean, a chemotherapy regimen, that's used for the treatment of lymphoma, and see whether or not by having complimentary mechanisms of action. We can that can translate into greater clinical benefit. The second question is really about the ability of regiments, such as our bend or chop to also serve themselves as conditioning regimens that can.

Facilitate $5 six or 596 pharmacokinetics and so the purpose of doing both of these investigations is really hold on those two different concepts.

Wayne Chu: You know, and with respect to Rituximab plus Vendamustine, you know, R-Venda is a standard therapy that's used in a broad array of B-cell malignancies, both aggressive lymphomas as well as indolent lymphomas. And, you know, data from the University of Pennsylvania have demonstrated that single-agent bendamustine could actually serve also as conditioning therapy for autologous CD19 C So our intention to combine FD516 with ARP Benda is really to extend that.

And with respect specifically with respect to <unk> plus then the Mustang.

Our Venda is a standard therapy, that's used in a broad array of b cell of malignancies, both aggressive lymphomas as well as indolent lymphomas.

Data from the University of Pennsylvania has demonstrated that single agent Bendamustine could actually serve also as conditioning therapy for our targets CD 19, Carty. So our intention to combine FTE $5 six with our Bender is really to extend that concept and then certainly the same principles hold true when.

Wayne Chu: And then certainly, you know, the same principles hold true when looking at combinations of FT596 with RCHOP, right? And the implication there, of course, is that if you can demonstrate additive activity as well as the ability of RCHOP to serve as a conditioning regimen for cells, then that has significant implications with respect to how we treat patients who have been newly diagnosed. Next question comes from the line of Daina Graybosch from SVB

Looking at combinations of 50, 596, with our chop right and the implication there of course is that if you can demonstrate.

Additive activity as well as the ability of our chop to serve as a conditioning regimen for cells than that has significant implications with respect to how we treat patients with newly diagnosed disease.

Your next question comes to Atlanta being agree Bosch from SBB theory, Lance now open.

Yeah, I I wanted to ask a follow up to lean what you just said under our top in particular and can you talk about how you might design the trial to understand both of those goals over conditioning and is there any other data and the community or in academic settings that talks about our shows how the top.

Wayne Chu: Yeah, I want to ask a follow-up question to what Wayne said about RCHOP in particular. Can you talk about how you might design the trial to understand both of those goals over conditioning? And is there any other data in the community or in academic settings that talks about or shows how the CHOP part of RCHOP could be a conditioning regimen for self-therapy?

Part of our top can be a conditioning regimen first I'll therapy.

So I'll I'll take the first part of the question then I'll turn it to win so Dana I think it's a little bit early for us to talk about what our development strategy is with respect to our shop, obviously, we do have one.

Daina Graybosch: So I'll take the first part of the question, then I'll turn it to Wayne. So, Daina, I think it's a little bit early for us to talk about what our development strategy is with respect to RCHOP. Obviously, we do have one, and we're thinking it through very carefully. I think the one thing that we're interested in demonstrating off the bat is, do we see in the first couple patients anything that is disqualifying?

We're thinking it through very carefully.

The one thing that we're interested in demonstrating off the bat is there do we see in the first couple of patients anything that as disqualifying and so for instance, we obviously this has not been done before almost all cell therapy has been delivered in conjunction with Si flu and so we will be looking carefully at the translational data both safety and.

Daina Graybosch: And so, for instance, obviously, this has not been done before. However, almost all cell therapy has been delivered in conjunction with CyFlu. And so we will be looking carefully at the translational data, both safety and translational data, that would suggest or support the ability to deliver FT596 without CyFlu in combination with RCHOP, where RCHOP can provide the necessary sort of background for the cells to flourish and have potent activity. I think I'll turn it over to Wayne to answer the second part of that question.

Daina Graybosch: And I apologize; could you just repeat that second part of the question so that I'm clear? I just wondered if, like Benda Mustang, there's anything combined in self-therapy with CHOP that you can lean on or gives you confidence in your strategy.

<unk> data.

That would suggest or support the ability to deliver FTE 596, without sigh flu in combination with art shop, where our chop can provide the necessary sort of background for the cells too.

Flourish and have potent activity I think I'll turn it over to Wayne to answer the second part of that question.

Colleges could you just repeat that second part of the question so that clear.

I just wondered if like Bender masking, there's anything combine itself therapies, a chop that you can lean on it gives me confidence in your strategy.

Clark Walchko: Yeah, so as Scott mentioned, this is the first time that we're kind of embarking on this with respect specifically to CHOP. So I think the question is still, you know, a very valid one until we start generating clinical data. I would say that, conceptually, it's similar to that of ARBENDA, and I think the key question is whether or not CHOP, when you give it to patients, especially when you give it multiple cycles over, you know, over six cycles, whether or not that can achieve the same conditioning effect as what we typically see with FUSAI.

Yeah. So.

Scott mentioned this is the first time that we're we're kind of embarking on this with respect specifically to chop. So I think the question is still a very valid one until we start generating clinical data I would say that conceptually, it's similar to that of our vendor and I think the key question is whether or not.

Chop when you give it especially when you give it multiple cycles over over six cycles, whether or not that can achieve the same conditioning effect as what we typically see with food sigh it may be very different.

Clark Walchko: It may be very different, and that's what the intention of this study is, to really start, you know, interrogating those questions. I mean, I think I'll pick up on that. I mean, it's a very different paradigm than, for instance, the PSY-FLU paradigm, right? So obviously, standard of care R-CHOP and standard of care R-BENDA are given in multiple cycles. And for instance, with R-CHOP, the cycles are literally, I think, wait, don't correct me, 21 days apart.

And that's what the intention of this study is to really start.

And targeting those questions.

I think I'll I'll pick up on that I mean think of it as a very different idea of combining with our chopper. Our vendors are very different paradigm. Then for instance, the sigh flew paradigm right. So obviously standard of care or chopped standard of care or Bender are given in multiple cycles.

For instance, with our shop the cycles are literally I think wino correct me 21 days apart. So we're talking about being able to add 5962, each cycle of art shop, and B and assess obviously the cells performance.

Clark Walchko: So we're talking about being able to add 596 to each cycle of R-CHOP and assess, obviously, the cells. So a very, very different paradigm than what's currently... Utilize for Self-Help

So very very different paradigm than what's currently.

Utilized for cell therapy.

Alright, thank you.

Operator: Great, thank you. Question comes from the line of Michael Schmidt. Hey, this is Kelsey on behalf of Michael.

Your next question comes from the line of Michael Schmidt from Guggenheim Alliance and open.

Hey, this is kelsey on for Michael Thanks for taking our questions.

Kelsey Goodwin: Thanks for taking our questions. On SP596, I guess you've noted you're treating patients in multi-dose, multi-cycle. I wonder how many cycles are you planning to give there?

And an S. P 596, Uhm I guess, you've noted you're treating patients in multi dose multi cycle I guess, how many cycles are you planning to give their and then regarding the decision in the second half of the year for pursuing either 516 or 596, I guess is that specifically for the post.

Kelsey Goodwin: And then regarding the decision in the second half of the year about pursuing either 516 or 596, I guess, is that specifically for the post-CAR T patient cohort, or are you choosing the go-forward product, you know, more broadly? And then will early 819 data inform that decision at all? Thanks. Wow, there's a lot in there. Sorry about that.

Car T patient cohort or are you choosing to go for a product.

Suddenly and then we'll early 819 data inform that decision at all thanks.

Thanks.

While there is a lot in there [laughter].

Clark Walchko: That's okay. I know. I'm sorry.

Okay.

That's okay [laughter].

Clark Walchko: That's okay. It's okay. Look, the decision around the development of the lymphoma strategy is obviously multifactorial. There are lots of obvious considerations, but we are very comfortable that, at the end of the day, there may in fact be a multiproduct franchise in lymphoma. There are plenty of targets, plenty of opportunities, and patients to serve in lots of different settings. We're very comfortable with the fact that there may be a multiproduct franchise in lymphoma. How we make that decision, I'm not necessarily going to get into it necessarily on the call, but it's certainly multifactorial, um, I don't know, Wayne, if you want to add anything to that.

Looked at the decision around the development of the lymphoma strategies, obviously multifactorial there are lots of obviously considerations, but we are very comfortable that at the end of the day. There may in fact be a mole pie product franchise and lymphoma, there are plenty of targets plenty of opportunities patient.

To serve and lots of different settings. So we're very comfortable with the fact that there may be a multi product franchising lymphoma.

How we make that decision I'm not going to get into it necessarily on the call, but it's certainly multifactorial.

I don't know Wayne if you want to add anything to that you already thing I would add to that and it's just to emphasize the fact that while we are we are aggressively pursuing a potential fast to market strategy and a specific population of patients who progressed through on prior carty are clinical investigations for all of these products expect.

Clark Walchko: The only thing I would add to that is, and this is just to emphasize the fact that while, you know, we are aggressively pursuing a potential fast-to-market strategy in a specific population of patients who have progressively left prior CAR-T, our clinical investigations for all of these products extend well beyond that. We are looking at other patient populations in parallel with this potential fast-to-market approach, and so I would imagine, I would, I think it's safe to assume that the broad development strategy will be reflected in, you know, what data we get from these other patient populations for all of our products. So you have not only multiple product candidates, but you also have a multitude of B-cell indications in which these products can operate optimally. Now, with all that said...

Our extended well beyond that we are looking at other patient populations in parallel with this potential fast market approach and so I would imagine I would I think it's safe to assume that the broad development strategy will be reflected on what data we get from these other patient populations for all of our products. So you have not only.

Multiple product candidates.

But you have a multitude of b cell indications.

And which of these product can operate optimally.

Now with all of that said.

Clark Walchko: I will continue to maintain that we are big believers in multi-antigen targets. We think that will add significant value to patients. And so, I will continue to maintain that at the end of the day, we believe FT-596 is a best-in-class NK cell product candidate, and that includes with respect to FT-566. We gotta generate more data.

I will continue to maintain that we are big believers in multi antigen targeting.

We think that will add significant value to patients and so I.

I will continue to maintain that at the end of the day.

We believe FTE 596, as a best in class NK sell product candidate and that includes with respect to FTE 516, we're got to generate more data. We're certainly now looking at the first multi dos multi cycle experience with FTE 596.

Clark Walchko: We're certainly now looking at the first multi-dose, multi-cycle experience with FT-596. But today, we'll continue to maintain FT-596 as a best-in-class product candidate. And if that becomes, you know, for instance, our lead CD19, CD20 targeted strategy in lymphoma and our best-in-class way to engage rituximab, I'm not gonna apologize for that at the end of the day. Got it, okay. Thank you. Your next question comes from the line of Nick Abbott. All right, thanks, everyone. We'll start in just a moment.

But today, we continue to maintain FTE 596 of the best in class product candidate and if that becomes.

For instance, our lead CD 19, CD 20 targeted strategy and lymphoma.

And and our best in class way to engage we're <unk> I'm not.

Not going to apologize for that at the end of the day [laughter].

Got it okay. Thank you.

Your next question comes from the Lion a snake habits.

From Wells Fargo and lines now open.

Nick Abbott: So good afternoon, Scott and Co., and thanks for a terrific update, as always. Maybe just starting on this postcard theme, you know, clearly, from the data you've shown to date, the activity in patients who are primary failures is less durable than that in those who are not primary failures. And I acknowledge these are still relatively low doses, but as you go forward here, do you look at both of these populations as one population or as discrete populations? And I have a follow-up question. Yeah, so I think that's a fair question.

How can I help you <unk> and co and thanks for insurance company. It is always.

Maybe just starting on this postcard T.

Clearly the data you have shown today.

Uhm.

Activity in patients who primary failures.

His last gerbil then those humans.

I'm not primary failures and acknowledged visa still relatively low doses, but as you as you go forward here do you do look at both of these populations as one population or because.

Discrete populations and then I have a follow up thanks.

Yeah. So I think that's a fair question I think it's one of the reasons I T.

Clark Walchko: I think it's one of the reasons why, you know, I talked about continuing to generate data with both FT516 and 596. We certainly are looking at patients down the line for CAR T cell therapy that have previously responded to CAR T, and we're certainly looking at patients that are refractory to CAR T. And so as we think about crafting our registration strategy and the pivotal trial design, we will continue to be guided by data. And then there's been a couple of publications recently of patients who have failed CD19 CAR-T following a CD19 bispecific. And it's pretty clear that that sort of epitope coating is preventing that.

Talked about continuing to generate data with both FTE 516 and 596.

We certainly are looking at patient down line of car T cell therapy that.

Have previously responded to Karachi, and we are certainly looking at patients that are refractory to carty and so as we think about crafting alternately our registration strategy and the pivotal trial design, we will continue to be guided by data.

Okay.

And then it has been a couple of publications recently all.

Patients who failed CD 19 coffee following a C D 19 by specific.

It is pretty clear that that sounds <unk>.

Mm coaching that's preventing that so yeah.

Clark Walchko: So given the likely uptake of CD19 bispecifics, is that a population that you think you can access with the Rituximab combo while CD19 washes off? Yeah, I mean, I'll let Wayne talk too, but I think that's one of the value propositions that we bring to the table with either 516 or 596.

Given likely uptake of C. D 19, Bispecifics is is that a population.

That you think you can access with the Rituxan that combo Walnut hold C. D 19, most yourself.

Yeah, I mean, I'll, let <unk> talk to but I think that's one of the value propositions that we bring to the table with either $5 16, or 596, CD 20 seems to be a very durable target throughout the lines of treatment. We certainly have seen terrific synergy between our HN CD 16 receptor and <unk>.

Clark Walchko: CD20 seems to be a very durable target throughout the lines of treatment. We certainly have seen terrific synergy between our HN-CD16 receptor and rituximab, including, as you mentioned, demonstrating complete responses down the line of CD19-targeted therapy. So yes, I continue to think the CD20-targeting strategy in combination with rituximab is definitely differentiated. The only thing that I would add is, you know, specific to your question around T cell engagers, we know where the target is CD19, and the CD19 target P cell engagers have relatively short half-lives because they're not of an antibody format that the militia has. In that context, there's still a possibility, you know, for the use of a CD19-targeted self-therapy with a relatively short washout from prior CD19 engagement. Great, thanks. And then, you know, just a last one.

And so including as you mentioned demonstrating complete responses down line of C. D 19 targeted therapies. So yes, I continue to think the <unk> CD 20 targeting strategy in combination with Rituxan map.

Is definitely differentiated.

Only thing that I would add is specific to your question around T cell engages that we know where the target is exceeding 19.

Just keep in mind that most of these I've seen 19 targeting T. So engages have relatively short halfway because they are not.

Antibody format.

Similar to from the CD 20, Engagers, which are more full length.

Antibodies structured.

So.

In that in that context, there is still a possibility for the use of a CD 19 targeted itself therapy with a relatively short washout from prior 19 engaging antibodies.

Alright, Thanks, and then.

<unk>.

The last one.

Clark Walchko: For me, Annette, just going back to AML, that was kind of the first therapeutic franchise update you gave last year, Scott, around mid-year. And so do we take it from your comments that you've sort of completed the 516 dose escalation now, perhaps some expansion, but the data there are not compelling enough to move forward. And then have you considered looking at this in high-risk MDS being, is that sort of considered less aggressive refractory AML? Thanks. Yeah, I think our strategy has not changed at all.

For me and that is just going back to the email that was kind of the first therapeutic franchise until you gave losses called around maybe and so do we take it from your comments that you sort of completed the 516000 installation now.

Perhaps some expansion, but is the date of their not compelling enough.

To move forward and then have you considered looking at this in high risk Nbsp is that so that's considered a mess aggressive and refractory AML. Thanks.

Yeah, I think our all our strategy has not changed at all at the end of the day, we don't plan on advancing or then one product candidate in their relapsed refractory AML setting we are making development decisions and that's on what we think are our best in class product candidates and we were.

Clark Walchko: At the end of the day, we don't plan on advancing more than one product candidate in the relapsed refractory AML setting. Instead, we are making development decisions and bets on what we think are our best-in-class product candidates. And we were always in the development mode, if you will, where we said we wanted to complete dose escalation with FT538, including up to 1.5 billion cells, and then make a further development decision. And nothing has changed. Your next question comes from Matt Biegler from Oppenheimer. Oh, hey guys, perfect timing.

Always in the development mode. If you will where we said we wanted to complete dose escalation with F. T 538, including up to 1.5 billion cells, and then make a further development decision and.

And nothing has changed there.

Thank you.

Your next question comes from line of math Bickner from Oppenheimer Lance and open.

Oh, Hey, guys perfect timing I actually wanted to ask a follow up on the prior ammo question.

Matt Biegler: I actually wanted to ask a follow-up on the prior AML question. It might be philosophical at this point, but do you think that NK cell therapy can be curative on its own, or is it always going to need to be combined with a standard of care stem cell transplant? And if it's the case where you do need a stem cell transplant, have you guys considered exploring 538 or one of the other products in an earlier treatment setting? This kind of gets to what the broader corporate strategy is, but maybe looking at AML in the MRD positive space post-induction but pre-transplant. Thanks.

And it might be philosophical at this point that do you think that N K cell therapy can be curative on its own or is it always going to need to be consolidated with our standard of care stem cell transplant.

And if it the case, where you do need a stem cell transplant have you guys considered exploring 538 or one of the other products and and earlier treatment setting I guess.

Kind of get to what the broader corporate strategy is but maybe I'm looking at a melon like the M. R D positive space.

Most induction, but pre transplant. Thanks.

Yeah. We are so we're doing a lot of work internally on a next step with respect to the development of the AML franchise. I think as you are alluding to there are multiple development opportunities that exist in treating patients earlier and care.

Clark Walchko: Yeah, so we are doing a lot of work internally on a next step with respect to the development of the AML franchise. I think, as you're alluding to, there are multiple development opportunities that exist in treating patients earlier in care. Treating multiply relapsed or refractory patients is obviously a difficult space given how sick these patients are, given the frailty that many of these patients are with respect to age and the lines of treatment that they've gone through, given the fact that, usually, in multiply relapsed refractory patients also, the bone marrow has been permanently damaged.

I'm treating multiply our relapsed refractory patients is obviously a difficult space given how sick. These patients are given the frailty.

Many of these patients are with respect to age and lines of treatment that they have gone through given the fact that usually multiply refract relapsed refractory patients also.

The bone marrow has been permanently damaged so I think the curative potential in AML. Yeah. I think you have to intervene earlier and I also mentally believe that most likely if you want to deliver cures and AML, you're probably best suited by a targeted strategy one of the challenges in it.

Clark Walchko: So I think the curative potential in AML, I think you have to intervene earlier. And I ultimately believe that, most likely, if you want to deliver cures in AML, you're probably best suited to a targeted strategy. One of the challenges in AML, obviously, is with targets.

Clark Walchko: We're obviously really interested in what we're going to see here with FT538 in combination with daratumumab. But certainly, I do think targeting leukemic blasts in the bone marrow and intervening earlier in care provides the best chance of a curative outcome. Flynn, do you want to add anything to that?

Well, obviously is with targets were were obviously really interested in what we're we're going to see here with FTE 538 in combination with Dar to mab, but certainly I do think targeting leukemic blasts in the bone marrow.

And intervening earlier and care provides the best chance of a curative outcome.

Oh I don't know if you want to add up on that note.

Clark Walchko: No, just exactly as Scott said, I think, you know, the value of going in early line is to try to provide some form of therapy where you can give it before the bone marrow gets totally obliterated by repeated rounds of treatment, so that we're always cognizant about opportunities to go into early line. And, you know, of course, that's not just AML, that's even B cell malignancies; you can make And obviously, in order to pursue that strategy, one of the concerns with AML is the frailty of patients. So you have to have a pretty exquisite safety profile to enable that.

Exactly as Scott said I think the value of going in early line is to try to provide some form of therapy, where you can give it before the bone marrow gets totally obliterated by repeated rounds of treatment. So that we're always cognizant about opportunities to go into earlier line and you know of course that that's not just the ammo that's.

Even be some malignancies, you can make a similar argument in that regard.

And obviously in order to pursue that strategy.

One of the concerns with AML as the reality of patients. So you'll have to have a pretty exquisite safety profile to enable them.

Yeah 4.6.

Clark Walchko: Yeah, fair point, thanks. Your next question calls to the line of Mara Goldstein from Mizzou. Hi, this is Sopoet from Mara.

Your next question comes from the line of Mara Goldstein from Mizuno Alliance Melbourne.

Hi, I'd be the support for my Aura Uhm. Thank you for taking the question my questions on F. T. A 19 can you expand a little bit on the rationale behind it.

Sopoet: Thank you for taking the questions. My question is on FT-819. Can you expand a little bit on the rationale behind different cohorts exploring lower IL-2 and split dosing? And related to that, with its unique design, perhaps the treatment regimen, do you expect FT-819 to be differentiated from other allogenic carotene developments, particularly in durability? Thank you.

Different cohorts exploring.

I am too and said dosing and and related to that <unk> beside you know.

Half the treatment regimen do you expect if in 19 819, three different shaded from other allergenic housing development, particularly on that they were Betty. Thank you.

Wayne Chu: So, thank you for the question. So, regarding FT819, you know, the way I would look at FT819 is that the nice thing about that study is that it is an opportunity to exploit a lot of the features of iPSC-derived CAR-T cells that, you know, with the end goal of having a better therapeutic index or better clinical activity than current-generation CD19-targeting CAR-T. And so, the reason for, you know, each of the different regimens in that study is to address specific components regarding the efficacy and safety of FT819.

So thank you for the question so regarding FTE 819.

The way I would look at FTE 819 is that correct.

The nice thing about that study is that it.

It is an opportunity to exploit a lot of the features of IPSA derived car T cells.

With the end goal.

Of having a better therapeutic index or better clinical activity, then current generation C. D 19 targeting carty and so the reason for the each of the different regimens in that study is to address specific components regarding the efficacy and safety of FTE 819. So for example, the addition.

Wayne Chu: So, for example, the addition of IL-2, you know, is to really explore the value of that cytokine to promote T-cell persistence and function. We know from multiple T-cell-based therapies of the importance of IL-2. So, we believe that assessing the addition of IL-2 is an important clinical experiment.

Of IL too.

Is to really explore the value of that cytokine to promote T cell persistence and function, we know from multiple T cell base there.

Therapies that of the importance of oil too. So we believe that assessing the the addition of IL two it's an important clinical experiment.

Equally as important as the ability to take advantage of the off the shelf on demand features of those cell product like FTE, 819, and see whether or not the flexibility around dos and schedule offers an opportunity to improve the clinical risk.

Wayne Chu: Equally important is the ability to take advantage of the off-the-shelf, on-demand features of a cell product like FT819 and see whether or not the flexibility around dose and schedule offers an opportunity to improve the clinical risk-benefit profile of the product. And so the purpose of the multiple dose regimen, you know, where FT819 is given on day one, day three, and day five of each treatment cycle, is not only to evaluate the ability of multiple doses to drive deeper responses but also to see whether or not flexibility with respect to individual day doses can lead to a better safety profile.

Benefit profile of the product and so the purpose of the multiple dose regimen, where FTE 819 is given on day, one day, three and day five of each treatment cycle is not only to evaluate the ability of multiple doses to drive deeper responses, but also to see whether or not flexibility with respect to.

Individual date dose can lead to a better safety profile.

Wayne Chu: And this is exemplified by the experience of the University of Pennsylvania, where they were able to use a multi-dose cycle of their autologous CD19 CAR-T product to actually improve the safety outcomes in patients with relapsed refractory ALL. So we are looking at that as an opportunity to do the same thing here with FTA-1. And I'd also say, just with respect to other programs, Look, this is pretty

This is exemplified by by the experienced from the University of Pennsylvania, where they were able to use a multiple dose cycle I'll start multi does cycle of a conga CD 19, carty product to actually improve the safety outcomes in patients with relapsed through factory Aol's. So we are.

Looking at that as an opportunity to do the same thing here.

One night.

I'd also say just respect with respect to other programs.

Okay.

This is pretty novel.

Clark Walchko: Sure, it's a CAR T-cell, and you can think of it that way. And you could say, gosh, it's going to look like an autologous CAR T-cell or a donor-derived T-cell. But there are some substantial differences here with respect to the targeted insertion of a CAR into the track locus and with respect to the CAR construct we're using, which is a novel C

Sure. It's a car T. Selling you can think about it that way and you could say gosh, it's going to look like an autologous car T cell or a donor derived T cell, but there are some substantial differences here with respect to the targeted insertion of a car into the track Lucas.

With respect to the car construct we're using which is a novel car construct one X X.

Clark Walchko: With the perspective that we are making a fairly homogeneous patient cell type, that is, the majority of cells are of a memory phenotype, and so we do think that the outcomes with FT-819 do have the potential to be very differentiated. I think one of the challenges associated with, let's call it, even patient-derived CAR T-cell therapy but certainly donor-derived CAR T-cell therapy is that the cells do go through an extensive period of manufacture and processing at the T-cell level.

With a perspective that we are making a fairly homogeneous patient cell type with.

That is.

Already have cells are of a memory phenotype.

And so we do think that the outcome's with a FTA 19 do have the potential to be very differentiated I think one of the challenges associated with let's call. It even patient derived car T cell therapy, but certainly donor drive car T cell therapy is the cells do go through.

An extensive period of manufacturing processing at the T cell level.

Clark Walchko: And that can cause T-cell exhaustion. I mean, even in the patient-derived car T-cell world, there was a desire, and there is a desire, to significantly reduce the manufacturing time. And that certainly has to do with vein-to-vein time to reach patients, but it also has to do with the potency of the cells, the T-cells themselves.

And that can cause T cell exhaustion, I mean, even in the patient derived car T cell world. There was a desire there is a desire to significantly reduce manufacture time and that certainly has to do with being to the time to to reach patients, but it also has to do with the potency of the cells the T cells themselves and so.

Clark Walchko: And so I think one of the unique features of our IPS-derived cell product is that we create significant numbers of T cells without actually, for any significant time, expanding the T cell population. And so we think we are creating a very potent T cell that has very low expression markers of exhaustion, and that can potentially be very different.

I think one of the unique features of our Ips derived sell sell product is we create significant numbers of T cells without actually for any significant time, expanding the T cell population and so we think we are creating a very potent T cell that.

Has very low.

Expression markers of exhaustion and that compete potentially be very differentiating.

Got it thank you.

Your next question counsel lineup robbing Carnous class from tourists Securities Alliance Nobody.

Sopoet: Thank you. Your next question comes in on the line from Robin Karnaskas from TruVizion. Hi, thanks, guys, and thanks for the great update. So I guess one small one, probably a stupid question, and a bigger one.

Hi, Thank skies and thanks for the great update so I guess, one small one probably see the question in a bigger one.

Robin Karnaskas: So for the 596 dose exclusion to 1.8 billion, I know before you talked about 900 million times two and then maybe a third dose. Can you just clarify? When you're just up to 1.8 billion cells, would that be 1.8 at day one and day 15, or are you talking about another round of dosing? And then the second question, which is broad, is that I think last year in oncology in general, not just fate, we're all plagued by expectations being so high.

For the 596 Uhm Joseph question to 1.8 billion I know before you talked about 900 million times too and then maybe a third dose can you just clarify when you're just everything to 1.8 billion cells would that be.

Uhm 1.8 at the one in <unk> are you talking about like another round of dancing and then the second question, which is broad is that I think last year and oncology in general not just faint we're all plagued by.

Expectation thing so high up on what C very more complete in such with longer durability, and you've got you said, you're gonna get some updates and that that can help you here a couple of programs with I think a huge focus on your 536 programs.

Robin Karnaskas: Everyone wants to see very complete data sets with longer durability. And you've said you're gonna get some updates in the second half of the year on a couple of programs with, I think, a huge focus on your 536 program. Have you set any changes in your internal bar as far as what that is?

Have you set any changes in your internal bar as far as like what.

Clark Walchko: You will, https://www.kenhub.com. So the first one's pretty easy. So the first one, we're doing two doses of 900 million cells, day one and day 15. We have the ability, obviously, to do two cycles now of day one and day 15 at 900 million cells. And actually, we have the ability to do more than two cycles as well with FT596 under the protocol with the FDA. Certainly, with a couple of patients showing safety, we're able to expand that treatment schedule.

You will.

<unk>, Yeah, just clothes and just say at some point <unk>, we won't disclose data and left this mature given an environment, where any given last year's debacle I think with all of oncology.

Shifting how much standards required for investors to make an assessment, if something was real or not.

So the first one is pretty easy so the first one we're doing two doses of 900 million cells day, one and day 15, we have the ability obviously to do two cycles now of day, one and day 15 at 900 million cells and actually we have the ability to do more than two cycles as well with F. T 596 under.

The protocol with the FDA.

Certainly with a couple of patients showing safety were able to expand that.

Treatment schedule and while we're expanding we will very likely explore a higher dose where the dose to be clear is 1.8 at day, one and 1.8 at day 15, and again, we could give a second cycle of that or even more than two <unk>.

Clark Walchko: And while we're expanding, we will very likely explore a higher dose where the dose, to be clear, is 1.8 at day one and 1.8 at day 15. And again, we could give a second cycle of that or even more than two cycles of that. So yeah, we're going to do a little bit more dose escalation here and go to 1.8 billion cells delivered on day one and day 15.

It goes with that so yeah, we're going to do a little bit more dose escalation here and go to 1.8 billion cells delivered on day, one and day 15.

With respect to.

Clark Walchko: The sort of the broader environment Look, we're doing something at Fate Therapeutics that is incredibly novel, and I am going to continue, within all reason, to be as transparent as possible with respect to what we're doing and what we're saying. I, you know, I, I guess it's just my philosophical perspective.

The sort of the broader environment look I'm a I'm a.

We're doing something at fate therapeutics that is incredibly novel.

And I am going to continue within all reason to be as transparent as possible with respect to what we're doing and what we're seeing.

I.

Get a gist my philosophical perspective.

Thank you that's that's helpful to hear it. Thank you so much.

Clark Walchko: Thank you. That's helpful to hear it. Thanks so much.

Your next question comes from the line has to be a a dire from S. M B C.

David Dye: Your next question comes from David Dye from South Africa. Hi, thanks for taking my questions. So, my question is on the FT-516 plus Arbenda or R-CHOP without side-flow conditioning. So, we have been increasingly seeing, based on allogeneic CAR-T data, that we need intense influence depletion in order to see CAR-T expansion. Could you just provide some color as to what gives you the confidence that FT-516, Arbenda, or R-CHOP could expand in the absence of side-flow?

Hi, Thanks for taking my questions. So my question is on the F. T 516, plus our bender or or chop with those types of conditioning. So I've seen <unk> have increasing think based on all the genetic hard T data, we need intense influence depletion <unk> cardi expansion could you provide some color as to what people.

The confidence that S. T 516, our <unk>, our job could extending the absence of such thanks.

I think I'll I'll, let weighing talked to it but I think it's one of the reasons. We're doing the study I mean, certainly we've seen different environments that were cells can perform under I think if I speak specifically about Si flu or are shot or we don't we're not so sure with our chop, yet, but our Bender certainly.

Clark Walchko: I'll let Wayne talk about that, but I think it's one of the reasons we're doing the study. I mean, certainly we've seen different environments that cells can perform under. I think, you know, if I speak specifically about CyFlu or R-CHOP, or we don't, we're not so sure about R-CHOP yet, but R-BENDA, certainly when you start thinking about delivering cells in multi-dose cohorts, or sorry, multi-dose treatment schedules, the reality is that, for instance, when you look at R-CHOP or you look at R-BENDA, So, for instance, you give R-CHOP and then 21 days later, you give R-CHOP again, and then 21 days later, you give R-CHOP again.

When you start thinking about delivering cells in mall tied dose cohorts are sorry, multi dose treatment schedules.

The reality is that for instance, when you look at our shopper you look at our Bender those treatments schedules. The window for instance that might exist with respect to Lymphodepletion is only for instance, 20 days. So for instance, you give art shop, and then 21 days later, you give arch up again, and then 21 days later <unk>.

Shop again, so we are not looking actually to achieve long term persistence of a cell we're looking to plug into multi dose treatment schedules, including standard of care that exists for early lying patients.

Clark Walchko: So, we are not actually looking to achieve long-term persistence of a cell. We're looking to plug into multi-dose treatment schedules, including the standard of care that exists for early-line patients. The treatment paradigm we're pursuing is not, with an NK cell, necessarily a patient-derived CAR T-cell paradigm of one dose and persistence of one dose. And quite frankly, I'm not even sure the persistence of a CAR T-cell, a patient-derived CAR T-cell, is correlated with long-term outcomes. There's a tremendous amount of data to suggest that long-term durable responses have nothing to do with long-term persistence of cells. It's all about the killing capacity and potency during the first 14, 21, and 30 days.

That would be hard on him that the treatment paradigm. We're pursuing is not with an NK cell is not necessarily a patient derived car T cell paradigm of one dose persistence of one dose and quite frankly.

Even sure their persistence of a car T cell a patient drive car T cell is correlated with long term outcomes. There's a tremendous amount of data to suggest that longterm durable responses have nothing to do with long term persistence of cells.

It's all about the killing capacity and potency during the first 14 21 30 days.

Thank you very <unk>.

Your next question constant line of Peter Lawson from Barclays and last hoping.

Clark Walchko: Thank you for your help. Next question comes from Peter Lawson from Barclays. Hey, Scott, just a follow-on question from David's question, just about how many indications do you think you can use IPSCs where you can kind of skip the condition regimen? Should we be thinking about that as any indication that has things like ARCHOP or ARBENDER? I mean, we're going to get a first look.

Hey, Scott just a follow on question from David's question, just about how many indications do you think you can use <unk>, where you can kind of skip the condition regiment should we be thinking about is any indication that has things like Ah chop off <unk>.

I mean, we're gonna take we're good at first look I mean right now it's all it's speculation at some basic level. We're certainly encouraged by the fact that when we've looked at Novartis is data with respect to use of bendamustine with and not sigh flu.

Peter Lawson: I mean, right now, it's all speculation at some basic level. We're certainly encouraged by the fact that when we looked at Novartis' data with respect to the use of bendamustine and not CyFlu, certainly, I think, you know, we've seen sort of evidence that you can move away from CyFlu and use R-bendam. I'll also say, I mean, keep in mind, and this is really important, a big part of what CyFlu is about cytokine spiking within the patient. So if it was about, for instance, immunogenicity or alloreactivity.

Certainly I think we've seen sort of evidence that you can move away from site flu and use our bender.

I'll also say I mean keep in mind and this is really important a big part of what size flew does.

Is actually about cytokine spiking within the patient. So if it was about for instance, immunogenicity or aloe reaction reactivity.

Clark Walchko: The patient-derived CAR T-cell is delivered with CyFlux. It's delivered with CyFlu, or it's delivered with Bendamustine because the cells that are being adoptively transferred love to go into a cytokine-rich environment. Our cell therapies, starting with FT-596, have cytokine support engineered into them. So they are less reliant, we believe, and less dependent on the conditioning regimen, spiking cytokines, because our cell therapies have cytokine support engineered into them.

Patient derived car T cell is delivered with sigh flu.

It's delivered with Si flu or it's delivered with Bendamustine because the cells that are being adopted Lee transferred love to go into a cytokine rich environment.

Our cell therapy, starting with FTE 596 have cytokines support engineered into them. So they are less reliant, we believe and less dependent on the conditioning regimen spiking cytokines, because our cell therapies have.

Cytokines support engineered into them.

Great. Thank you so much.

Clark Walchko: Great, thank you so much. There are no further questions at this time. I would now like to turn the conference back to Scott.

Sure.

There are no further questions at this time I would not like to turn the conference back to Scott Washco.

Clark Walchko: Terrific. I want to thank everyone for their participation in today's call and all the great questions. I look forward to providing you with updates in the coming months. Be well. This concludes today's conference call. Thank you for participating and have a wonderful day. Email disconnects. [music]

Terrific.

Thank everyone for your participation in today's call and all the great questions look forward to providing you updates in the coming months.

Be well take care.

This concludes today's conference call. Thank you for participating and have a wonderful day email disconnect. Thanks.

Okay.

[music].