Q2 2022 Fate Therapeutics Inc Earnings Call

[music].

Welcome to the Fate Therapeutics Second Quarter 2022 Financial Results Conference Call.

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

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

This call is being webcast live on the Investors section of the Fate website at fatetherapeutics.com.

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

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

Remind you today's call is being recorded I would now like to introduce Scott <unk>, President and CEO of fate therapeutics.

I would now like to introduce Scott Walshco, President and CEO of Fate Therapeutics.

Thank you.

Thank you good afternoon, and thanks, everyone for joining us for the fate Therapeutics second quarter 2022 financial results call. Shortly after four P. M. Eastern time today, we issued a press release with these results, which can be found on the investors section of our website under press releases. In addition, our.

Good afternoon, and thanks, everyone, for joining us for the Fate Therapeutics Second Quarter 2022 Financial Results Call.

Form 10-Q for the quarter ended June 32022 was filed shortly thereafter and can be found on the investors section of our website under financial information.

Shortly after 4 p.m. Eastern time today, we issued a press release with these results, which can be found on the Investors section of our website under Press Releases.

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.

In addition, our Form 10-Q for the quarter ending June 30, 2022, was filed shortly thereafter, and can be found on the Investors section of our website under Financial Information.

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. These statements involve risks and uncertainties that can cause actual results to differ materially, from those in such forward-looking statements. Please see the forward-looking statement disclaimer on the company's earnings press release issued, after the close of market today, as well as the risk factors included in our Form 10-Q for the quarter ending June 30, 2022, that was filed with the SEC today.

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

Please see the forward looking statement disclaimer on the company's earnings press release issued after the close of market today as well as the risk factors included in our Form 10-Q for the quarter ended June 32022 that was filed with the SEC today.

Any new reliance should not be placed on forward-looking statements, which speak only as of the date they are made, as the facts and circumstances underlying these forward-looking statements may change.

Undue reliance should not be placed on forward looking statements, which speak only as of the date. They are made as the facts and circumstances underlying these forward looking statements may change.

Except as required by law, SAIT Therapeutics disclaims any obligation to update, these forward-looking statements to reflect future information, events, or circumstances.

Sept as required by law fate therapeutics disclaims any obligation to update these forward looking statements to reflect future information events or circumstances.

Joining me on today's call are Dr. Wayne Chu, our Chief Medical Officer, Ed Dulac, our Chief Financial Officer, and Dr. Bob Ballamer, our Chief Research and Development Officer.

Joining me on today's call our Doctor Wayne Chu, our Chief Medical Officer, and do Lark, Our Chief Financial Officer, and Dr. Bob Ballmer, Our Chief Research and development Officer today, we will highlight key objectives, we are striving to achieve during the next six months with our off the shelf Ips derived NK and <unk>.

Today, we will highlight key objectives we are striving to achieve during the next six months, with our off-the-shelf, IPFC-derived NK and T-cell programs for the treatment of cancer.

So programs for the treatment of cancer.

Our top near-term focus remains our B-cell malignancy franchise, where we are seeking to advance into late-stage development for relapsed refractory aggressive lymphoma and to assess the feasibility of treating newly-diagnosed patients in a community setting with FT-596-plus ART-SHOP without PSY-Flu conditioning chemotherapy.

Our top near term focus remains our b cell malignancy franchise, where we are seeking to advance into late stage development for relapsed refractory aggressive lymphoma and to assess the feasibility of treating newly diagnosed patients in the community setting without T 596, plus art shop without <unk>.

I flew conditioning chemotherapy, we're also approaching key inflection points under our Ips derived car NK and car T cell collaboration with Janssen and Ono, where multiple programs are poised to advance toward IND submission.

We are also approaching key inflection points under our IPS-derived CAR NK, and CAR T-cell collaborations with Janssen and Ono, where multiple programs are poised to advance toward IND submission.

And with numerous hurdles continuing to challenge the manufacture and development, of patient and donor-derived engineered cell therapies, we continue to believe IPFC technology is the winning platform for mass production of off-the-shelf multiplex engineered cell products.

And with numerous hurdles continuing to challenge the manufacturing development of patient and donor derived engineered cell therapies. We continue to believe Ips cell technology with the winning platform for mass production of off the shelf multiplex engineered cell products, we look forward to sharing <unk>.

We look forward to sharing first-in-human clinical data from our engineered NK and T-cell, cancer immunotherapy programs and to unveiling new multiplexed engineered IND candidates that further incorporate novel synthetic functionality for the treatment of cancer during the next six months.

And human clinical data from our engineered NK and T cell cancer immunotherapy programs and to unveiling new multiplexed engineered IND candidates that further incorporate novel synthetic functionality for the treatment of cancer.

In our pursuit of pivotal readiness with our iPS-derived NK cell programs for relapse refractory aggressive B-cell lymphoma, we continue to make great strides across our clinical, regulatory, and manufacturing operations. Under our Phase 1 study of FT596 in combination with rituximab, we observed a favorable safety profile in our single-dose and two-dose escalation cohorts at up to 900 million cells per dose. And we are continuing to further evaluate dose and schedule to maximize therapeutic index.

We're in the next six months.

And our pursuit of pivotal readiness with our Ips derived NK cell programs for relapsed refractory aggressive b cell lymphoma, we continue to make great strides across our clinical regulatory and manufacturing operations.

For our phase one study of the FTE 596 in combination with Rituximab, we observed a favorable safety profile in our single dose and two dose escalation cohorts at up to 900 million cells per dose.

And we are continuing to further evaluate dose and schedule to maximize therapeutic index.

To that end, we have initiated enrollment in a single-dose and two-dose cohorts at 1.8 billion cells per dose. And upon clearance of dose-limiting toxicities, we are set to open a three-dose cohort at 1.8 billion cells per dose to evaluate a further increase in cell load. Eligible patients are permitted to receive additional cycles of treatment and the clinical protocol allows for further dose escalation and for the initiation of multiple expansion cohorts at any cleared dose and schedule.

To that end, we have initiated enrollment in a single dose and two dose cohorts at $1 8 billion cells per dose and upon clearance of dose limiting toxicities. We are set to open a three dose cohort at $1 8 billion cells per dose to evaluate a further increase.

In cell Logan.

Eligible patients were permitted to receive additional cycles of treatment and the clinical protocol allows for further dose escalation and for the initiation of multiple expansion cohorts at any clear dose and schedule.

On the regulatory front, our FT516 RMAT Type B multidisciplinary meeting with the FDA is scheduled for the third quarter. The agenda includes a discussion of multiple registrational pathways that may be available, for our off-the-shelf IPS-derived NK cell programs for relapse refractory aggressive B-cell lymphoma, including in patients whose disease is refractory to or have relapsed following prior treatment with FDA-approved CD19-targeted CAR T-cell therapy.

On the regulatory front, our FTE $5 16, Ormat type B multidisciplinary meeting with the FDA is scheduled for the third quarter. The agenda includes a discussion of multiple registrational pathways that may be available for off the shelf Ips derived NK cell programs for <unk>.

Lapsed refractory aggressive b cell lymphoma, including patients, whose disease is refractory to or have relapsed. Following prior treatment with FDA approved CD 19 targeted car T cell therapy.

Importantly, no standard therapies are available, to these patients and real-world data continue to indicate that these patients have extremely poor treatment outcomes.

Importantly, no standard therapies are available to these patients and real world data continue to indicate that these patients have extremely poor treatment outcomes.

With respect to manufacturing, our state-of-the-art multi-drug product manufacturing facility located in Poway, California has opened and is poised for GMP production with aseptic process validation now successfully completed and engineering runs ongoing. The facility is designed to supply drug product for the conduct of pivotal studies and initial commercial launch and is located on the campus of the company's corporate headquarters, allowing for full operational integration among the technical operations, regulatory equality, research and development, and corporate teams.

With respect to manufacturing our state of the art multi drug product manufacturing facility located in Poway, California has opened and is poised for GMP production with a septic process validation now successfully completed an engineering runs ongoing.

The facility is designed to supply drug product for the conduct of pivotal studies and initial commercial launch and is located on the campus of the Companys corporate headquarters, allowing for full operational integration among the technical operations regulatory and quality.

Research and development and corporate teams.

Across our clinical regulatory and manufacturing operations, we remained well positioned to optimize dosing schedule of FTE fog nine six to chart, a regulatory pathway toward approval with input from the FDA.

Across our clinical, regulatory, and manufacturing operations, we remain well positioned to optimize dose and schedule of FT-596 to chart a regulatory pathway toward approval with input from the FDA and to mass-produce drug product for pivotal study execution from our state-of-the-art GMP facility.

And to mass produce drug product for pivotal study execution from our state of the art GMP facility.

We look forward to providing a comprehensive update for, IPS derived NK cell programs in relapsed refractory B cell lymphoma as we continue to progress these three key franchise pillars over the coming months.

We look forward to providing a comprehensive update for our Ips derived NK cell programs in relapsed refractory b cell lymphoma, as we continue to progress. These three key franchise pillars over the coming months.

In addition to delivering transformative outcomes to heavily pre-treated patients, with relapsed refractory B cell lymphoma, we are also seeking to reach patients in the community setting who might benefit from earlier treatment with cell-based cancer immunotherapy.

In addition to delivering transformative outcomes to heavily pretreated patients with relapsed refractory B cell lymphoma. We are also seeking to reach patients in the community setting who might benefit from earlier treatment with cell based cancer immunotherapy, we believe the use of intense.

We believe the use of intense conditioning chemotherapy that accompanies the administration of both autologous and allogeneic cell-based cancer immunotherapies is a significant barrier to broader patient access and that the delivery of off-the-shelf cell therapies in the community setting as an add-on to frontline immunotherapy regimens without side fluid conditioning chemotherapy may hold significant therapeutic value for many patients. To that end, we have worked with key opinion leaders and investigators to finalize a clinical protocol that brings FT-596 to newly diagnosed patients with aggressive lymphomas in the community setting in combination with RCHOP, the standard first-line treatment regimen.

Conditioning chemotherapy that accompanies the administration of both autologous and allogeneic cell based cancer Immunotherapies is a significant barrier to broader patient access and that the delivery of off the shelf cell therapies in the community setting as an add on too.

<unk> line of chemotherapy.

<unk> regimens with outsized flu conditioning chemotherapy.

They hold significant therapeutic value for many patients.

To that end, we have worked with key opinion leaders and investigators to finalize a clinical protocol that brings FTE $5 96 to newly diagnosed patients with aggressive lymphomas in the community setting in combination with R. Chop.

The clinical protocol assessing FT-596 plus RCHOP in patients with newly diagnosed aggressive lymphoma has been submitted to the FT-596 IND. The treatment schema allows for the administration of up to six doses of FT-596 without side fluid conditioning chemotherapy, each one dose of FT-596 administered with each of six standard cycles of RCHOP.

Standard first line treatment regimen.

The clinical protocol assessing FTE 596, plus R. Chop in patients with newly diagnosed aggressive lymphoma has been submitted to the FTE 596.

<unk>.

The treatment schema allows for the administration of up to six doses of FTE 596, without psi fluid conditioning chemotherapy.

Each one dose of FTE $5 96 administered with each of six standard cycles workshop.

Study startup activities are ongoing at multiple sites and we expect to begin treating patients with FT-596 plus RCHOP in the second half of 2022.

Study startup activities are ongoing at multiple sites and we expect to begin treating patients with FTE five six plus R. Chop in the second half of 2022.

In addition, as part of our quest to substantially reduce or eliminate the, requirement for conditioning chemotherapy in the field of cell-based cancer immunotherapy and reach patients earlier in care, we continue to research new synthetic functional elements for integration into our product candidates that can harness a patient's intact immune system to potentiate the activity and persistence of adoptively transferred cells. At the American Association for Cancer Research in April, we unveiled our proprietary, Alloimmune Defense Receptor, or ADR, which selectively targets 4-1BB expressing activated immune cells.

In addition, as part of our quest to substantially reduce or eliminate the requirement for conditioning chemotherapy in the field of cell based cancer immunotherapy and reach patients earlier and care. We continue to research new synthetic functional elements for integration into our product.

Candidates.

That can harness a patient intact immune system.

Potentiate, the activity and persistence of Adaptively transferred cells.

At the American Association for Cancer Research in April we unveiled our proprietary allo immune defense receptor, where ADR, which selectively targets for <unk> expressing activated immune cells.

In preclinical models, we showed that ADR- armed, IPFC-derived NK cells uniquely expand, persist, and maintain anti-tumor activity in vitro in the presence of alloreactive T-cells. These preclinical data provide proof of concept that ADR arm cell therapies have the potential, to persist and induce potent anti-tumor activity without requiring a patient to undergo conditioning chemotherapy.

In preclinical models, we showed that ADR armed Ips derived NK cells uniquely expand persist and maintain anti tumor activity in vitro in the presence of the allo reactive T cells. These.

These preclinical data provide proof of concept that ADR arm cell therapies have the potential to persist and induce potent anti tumor activity without requiring a patient undergo conditioning chemotherapy.

During the second half of 2022, we expect to present new preclinical data for our ADR, therapy and highlight its integration into a next-generation NK cell product candidate.

During the second half of 2022, we expect to present, new preclinical data for our ADR technology and highlight its integration into a next generation NK cell product candidate.

Turning to our collaborations with Janssen and Ono, we continue to show strong momentum, in bringing multiplexed-engineered, IPS-derived CAR-NK and CAR-T cell collaboration programs to patients for the treatment of hematologic malignancies and solid tumors, and we are reaching key inflection points where multiple candidates are poised to advance toward IND submission. Under our collaboration with Janssen, entered into in April 2020, Janssen designated and, contributed novel binding domains targeting four tumor-associated antigen programs, two of which are directed to hematologic malignancies and two of which are directed to solid tumors.

Turning to our collaborations with Janssen and Ono, we continued to show strong momentum in bringing multiplexed engineered Ips derived car NK and car T cell collaboration programs to patients for the treatment of hematologic malignancies and solid tumors.

We are reaching key inflection points, where multiple candidates are poised to advance towards IND submission.

Under our collaboration with Janssen entered into in April 2020.

Janssen designated and contributed novel binding domains targeting for tumor associated antigen programs.

Two of which are directed to hematologic malignancies, and two of which are directed to solid tumors.

Janssen maintains the option, subject to its payment of an option exercise fee prior, to IND submission, to initiate worldwide clinical development of and to commercialize collaboration products under each antigen program.

Janssen maintains the option subject to its payment of an option exercise fee prior to IND submission.

To initiate worldwide clinical development of and to commercialize collaboration products under each antigen program.

We maintain an opt-in right to co-commercialize and share equally in profits and losses of, collaboration products in the U.S. under each antigen program. In May, Janssen exercised its option on a first antigen program, triggering a $10 million, payment fee, and we have now advanced a second antigen program to the stage of option exercise decision.

We maintain an opt in right to co commercialize and share equally in profits and losses of collaboration products in the U S under each and antigen program.

In May Janssen exercised its option on a first antigen program.

We're hearing a $10 million payment to fate.

And we have now advanced a second antigen program to the stage of option exercise decision.

We are currently working with Janssen to prepare and submit two IND applications, one for each, of these two antigen programs, for off-the-shelf, IPS-derived, CAR-NK cell collaboration products.

We are currently working with Janssen to prepare and submit two R&D applications.

One for each of these two antigen programs for off the shelf Ips derived car NK cell collaboration products.

Under our collaboration with Ono, entered into in September 2018, Ono has contributed, novel binding domains targeting one solid tumor-associated antigen for development of off-the-shelf, IPS-derived, CAR-T cell therapy. Upon the achievement of a specified preclinical milestone, Ono maintains the option, subject, to its payment of an option exercise fee, to conduct worldwide clinical development and commercialization, and we maintain the right to co-develop and co-commercialize collaboration products in the U.S. and Europe. We have now initiated the generation of the master cell bank for a multiplexed-engineered, IPS-derived, CAR-T cell collaboration candidate, and are positioned to achieve the specified preclinical milestone and initiate IND-enabling activities later this year, at which time Ono has the right to exercise its option subject to its payment of the option exercise fee.

Under our collaboration with Ono entered into in September 2018.

<unk> has contributed novel binding domains targeting one solid tumor associated antigen for development of off the shelf Ips derived car T cell therapy.

Upon the achievement of a specified preclinical milestone Ono retains the option subject to its payment of an option exercise fee to conduct worldwide clinical development and commercialization and we maintain the right to co develop and co commercialize collaboration products in the U S and Europe .

We have now initiated the generation of the Master cell bank for a multiplexed engineered Ips derived car T cell collaboration candid.

And our position to achieve the specified preclinical milestone and initiate IND, enabling activities later this year.

At which time <unk> has the right to exercise its option subject to its payment of the option exercise fee.

Given the success, we have achieved working together on our first solid tumor antigen program, we expanded our collaboration with Ono in the second quarter to add a second solid tumor antigen program and to include the development of both car NK and car T cell collaboration.

Given the success we have achieved working together on a first solid tumor antigen program, we expanded our collaboration with Ono in the second quarter to add a second solid tumor antigen program and to include the development of both CAR-NK and CAR-T cell collaboration candidates. We are very pleased with the success we've achieved with Janssen and Ono in developing multiplexed engineered IPS derived CAR-NK and CAR-T cell, product candidates for both liquid and solid tumors.

Candidates.

We are very pleased with the success, we've achieved with Janssen and Ono in developing multiplexed engineered Ips derived car NK and car T cell product candidates for both liquid and solid tumors. We are poised to achieve significant milestones in connection with option exercises by chance and an owner and advance.

We are poised to achieve significant milestones in connection with option exercises by Janssen and Ono and advance multiple collaboration products toward IND submission over the next six months.

Multiple collaboration products toward an IND submission over the next six months.

During the second half of 2022, we will take the opportunity to showcase our leadership in the development of IPS derived NK and T cell cancer immunotherapies including for solid tumors at the Society for Immunotherapy of Cancer annual meeting in November and for hematologic, malignancies at the American Society of Hematology annual meeting in December.

During the second half of 2022, we.

We will take the opportunity to showcase our leadership in the development of Ips derived NK and T cell cancer immunotherapies, including for solid tumors at the society for immunotherapy of cancer annual meeting in November .

And for hematologic malignancies at the American Society of Hematology annual meeting in December .

At CITSI, we look forward to highlighting our clinical progress and innovation, under our solid tumor franchise where we continue to invest in building a deep pipeline of multiplexed engineered IPS derived CAR-NK and T cell product candidates including through the development and incorporation of new synthetic elements designed to overcome critical barriers that limit the effectiveness of cell therapy such as cell homing, tumor escape, and the immunosuppressive tumor microenvironment.

At <unk>, we look forward to highlighting our clinical progress and innovation under our solid tumor franchise, while we continued to invest in building a deep pipeline of multiplexed engineered Ips derived car NK and T cell product candidates, including through the development and incorporation of new <unk>.

Thetic elements designed to overcome critical barriers that limit the effectiveness of cell therapy, such as cell homing tumor escape.

In the second quarter, I am pleased to announce that we treated the first patient in our multi-center phase one study of FT536, the company's first ever IPSC derived CAR-NK cell program for solid tumors. FT536 incorporates a novel CAR targeting the major histocompatibility complex class one related proteins A and B. High expression of McA and McB proteins which is induced by cellular stress damager transformation has been reported on many solid tumors.

The immunosuppressive tumor microenvironment.

In the second quarter I am pleased to announce that we treated the first patient in our multicenter phase one study of FTE $5 36, the company's first ever Ips derived car NK cell program for solid tumors.

536, incorporating novel car targeting the major histocompatibility complex class one related proteins, a and b.

High expression of <unk>, and <unk> proteins, which is induced by cellular stress damage. Our transformation has been reported on many solid tumors.

However, protolytic shedding of the alpha-1 and alpha-2 domains of these proteins is a common mechanism of tumor escape.

However, proto lytic shedding of the Alpha one and Alpha two domains of these proteins is a common mechanism of tumor escape.

FT536 uniquely targets the alpha-3 domain of McA and McB which is resistant to shedding and therefore represents a promising, strategy to overcome tumor escape.

<unk> hundred six uniquely targets the alpha three domain of nickname of Covid, which is resistant to shedding and therefore represents a promising strategy to overcome tumor escape.

We believe the product candidates novel mechanism of action, including its ability to target other antigens in combination with monoclonal antibody therapy.

We believe the product candidates novel mechanism of action including its ability to target other antigens in combination with monoclonal antibody therapy can be used in a variety of ways. For example, we have a number of, standardized and layered IPS derived CAR T-cell product candidates for solid tumors that are advancing toward IND enabling studies which include an IPS derived CAR T-cell product candidate that incorporates seven synthetic modalities to overcome tumor heterogeneity, promote trafficking, and induce activation in response to repressive signaling in the tumor microenvironment.

Feared Ips derived car T cell product candidates for solid tumors that are advancing toward IND, enabling studies, which include in <unk>.

<unk> derived car T cell product candidate that incorporates seven synthetic modalities to overcome tumor heterogeneity promote trafficking and induce activation in response to repressive signaling in the tumor microenvironment. We believe we have one of the most novel <unk>.

We believe we have one of the most novel, diverse, and sophisticated cell-based cancer, immunotherapy pipelines for solid tumors, which is uniquely enabled by our proprietary, IPFC product platform.

Worse and sophisticated cell based cancer immunotherapy pipelines for solid tumors, which is uniquely enabled by our proprietary IP FC product platform.

At ASH, we are also excited to share clinical data across our hematologic malignancy franchises.

At Ash, we are also excited to share clinical data across our hematologic malignancy franchises. In addition to our NK cell franchising lymphoma, we continued to see investigator enthusiasm for our off the shelf Ips derived car T cell program FTE 819.

In addition to our NK cell franchise and lymphoma, we continue to see investigator, enthusiasm for our off-the-shelf, IPS-derived, hard T-cell program, FT-819. On multiple fronts, FT-819 is truly a unique first-in-class product candidate. Not only is it the first-ever IPS-derived T-cell therapy to undergo clinical investigation, FT-819 incorporates a bioallelic insertion of an anti-CD19 CAR transgene into the T-cell receptor alpha constant locus, with complete disruption of T-cell receptor expression.

On multiple fronts FTE 19 is truly a unique first in class product candidate <unk>.

Not only is it the first ever Ips derived T cell therapy to undergo clinical investigation FTE 19 incorporates a bio <unk> insertion of an anti CD 19 car transgene into the T cell receptor alpha constant locus with complete disruption of tea.

Cell receptor expression.

And its CAR construct is comprised of a novel 1XX co-stimulatory domain that is designed, to balance T-cell activation and exhaustion.

And its car construct is comprised of a novel <unk> co stimulatory domain that is designed to balance T cell activation and exhaustion.

In the setting of relapsed refractory AML, we look forward to sharing clinical data with, FT-538, both as a monotherapy and in combination with daratumumab in the high-dose, multi-dose cohorts, where we are now treating the first patients in three-dose cohorts at 1.5 billion cells per dose.

In the setting of relapsed refractory AML, we look forward to sharing clinical data with FTE <unk> three eight both as a monotherapy and in combination with Dara tuna.

The high dose multi dose cohorts, where we are now treating the first patients in three dose cohorts at one 5 billion cells per dose.

And finally, in the setting of relapsed refractory multiple myeloma, while dose escalation with, FT-576 is ongoing in the low-dose cohorts and with single-dose treatment schedules, we look forward to seeing the initial activity profile of our novel BCMA binder and to assess the multiple potential benefits conferred in combining FT-576 with daratumumab, including enabling multi-antigen targeting of BCMA and CD38, as well as reducing competition from endogenous immune cells for cytokines to further potentiate the functional persistence of FT-576.

And finally in the setting of relapsed refractory multiple myeloma, while dose escalation with ft 576 is ongoing in the low dose cohorts and with single dose treatment schedules. We look forward to seeing the initial activity profile of our novel <unk> CMA binder.

To assess the multiple potential benefits conferred in combining FTE $5 76 with Dar tuna.

Including enabling multi antigen targeting of the CMA and CD 38, as well as reducing competition from endogenous immune cells for cytokines to further potentiate the functional persistence of up to $5 76.

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

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

Thank you, Scott, and good afternoon.

Thank you Scott and good afternoon.

State Therapeutics is in a strong financial position to advance our pipeline. Our cash, cash equivalents, and investments at the end of the second quarter of 2022 were, approximately $581 million. In the second quarter of this year, our collaboration revenue derived from our partnerships with, Janssen and Ono Pharmaceutical increased by $5.1 million to $18.5 million, compared to $13.4 million for the same period last year. Research and development expenses for the second quarter increased by $33.3 million, to $81.3 million, compared to $48 million for the same period last year. The increase in our R&D expenses was attributable primarily to increases in employee headcount and compensation, including share-based compensation, investments made in equipment and materials, and in expenses associated with R&D fees and third-party consultants.

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

General and administrative expenses for the second quarter increased by $8.2 million to $20.4 million, compared to $12.2 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 legal expenses. Total operating expenses for the second quarter were $101.7 million, which includes $20.5 million in non-cash, share-based compensation expense.

Our cash cash equivalents and investments at the end of the second quarter of 2022 for approximately $581 million.

In the second quarter of this year, our collaboration revenue derived from our partnerships with Janssen and Ono pharmaceutical increased by $5 1 million.

To $18 5 million.

Compared to $13 4 million for the same period last year.

Research and development expenses for the second quarter increased by $33 3 million to $81 3 million.

Compared to $48 million for the same period last year.

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

General and administrative expenses for the second quarter increased by $8 2 million to $20 4 million compared to $12 2 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 legal expenses.

Total operating expenses for the second quarter of $101 7 million.

Which includes $20 5 million in noncash share based compensation expense.

Please note that in connection with the development of our off-the-shelf, iPSC-derived CAR T-cell product candidate FT-819, we previously achieved the first clinical milestone set forth in our amended license agreement with Memorial Sloan Kettering Cancer Center, thereby triggering a first milestone payment to MSK in 2021. Up to two additional milestone payments may be owed to MSK based on subsequent trading values of the company's common stock, ranging from $100 to $150 per share.

Please note that in connection with the development of our off the shelf Ips derived car T cell product candidate FTE 819, we previously achieved the first critical milestone set forth in our amended license agreement with Memorial Sloan Kettering Cancer Center, thereby triggering a first miles.

Stone payment to <unk> in 2021.

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

We assess the fair value of these contingent milestone payments, currently valued at $9.9 million on a quarterly basis. In the second quarter, we recorded a non-cash $5.9 million non-operating benefit associated with the change in fair value.

We assessed the fair value of these contingent milestone payments currently valued at $9 $9 million on a quarterly basis.

In the second quarter, we recorded a noncash $5 $9 million non operating benefit associated with the change in fair value.

Our net loss for the second quarter of 2022 was $76.1 million, or $0.79 per share.

Our net loss for the second quarter of 2022 was $76 1 million or 79 per share.

Finally, our year-end cash guidance remains unchanged, and 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 Pharmaceutical.

Finally, our year end cash guidance remains unchanged and 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.

I would now like to open the call to questions.

I would now like to open the call to questions.

Thank you.

Thank you ladies and gentlemen, the floor is now open for questions. If you have any questions or comments. Please press star one on your phone at this time, we ask that while posing your question you. Please pickup your handset if they stay on it.

Ladies and gentlemen, the floor is now open for questions.

To provide optimum sound quantity. Please hold while we poll for questions.

If you have any questions or comments, please press star 1 on your phone at this time.

We ask that while posing your question, you please pick up your handset if listening on a speakerphone to provide optimum sound quality.

Thank you. Your first question is coming from Amit <unk> of Bank of America.

Please ask your question.

Please hold whilst we poll for questions.

Hi, good afternoon, and thanks for taking my questions.

Thank you.

Maybe a point of clarification.

Meaning that you sketch Alex this corner for $5 six.

Your first question is coming from Tazeen Ahmed of Bank of America.

Can you just give us a little bit more visibility on what you'll be discussing at the meeting.

When should we expect to hear back how that meeting one thanks.

Im going to have a follow up after that.

Tazeen, please ask your question.

Sure so I'm not going to get into the details of the regulatory discussion, but suffice it to say we are going to discuss multiple different registrational pathways for our Ips derived cell product candidates. We think those registrational pathways are applicable to both FTE.

Hi.

<unk> 16, as well as FTE 596 in particular, while we will focus on some development pathways that are more broadly applicable specifically I think we will drill down on the patient population that is post car T cell therapy, as we believe that as a potential fast to market strategy.

Good afternoon, and thanks for taking my questions.

Maybe a point of clarification, for this RMAP meeting that you scheduled this quarter for 5.16, can you just give us a little bit more visibility on what you'll be discussing at the meeting, and when should we expect to hear back how that meeting went?

And we would like to confirm specifically.

The study design with the FDA in that patient population.

Thanks.

Okay. Thanks for the color and then Lisa and sorry with respect to timing usually.

I would have a follow-up after that.

You will receive minutes from the FDA.

Documenting the conversation and the findings within about 30 days of.

Sure.

Okay, and then I guess you wait for the minutes to advisors.

I mean, so I'm not going to get into the details of the regulatory discussion, but suffice it to say, we are going to discuss multiple different registrational pathways for our IPS-derived cell product candidates. We think those registrational pathways are applicable to both FT516 as well as FT596.

Next.

Correct.

I certainly don't want to jump the gun on the FDA discussion.

In particular, while we will focus on some development pathways that are more broadly applicable, specifically, I think we will drill down on the patient population that is post-CAR-T cell therapy, as we believe that is a potential fast-to-market strategy.

Understood.

And we would like to confirm specifically a study design with the FDA in that patient population.

And then as it relates to the 596 and Rituximab protect from that study.

The $1 8 billion.

All dose cohort.

When do you think we could start to see data from that.

Okay.

And what type of data should we expect it to be good data based on what Youre looking for.

Thanks for the color.

Sure I'll turn it over to Wayne to comment on it with respect to a little bit.

In terms of what do we think would be good data I think again feasibility that we can give the ft 596 in combination with R chop and with outside fluid would be interesting and again many of those.

Validation sets of data will be based on translational. So for instance, we can continue to look at ft, $5 six and how it performed in the first cycle versus the six cycle of R. Chop and certainly we can compare that to how FTE 596.

<unk> from a translational perspective versus site flu given the number of patients we've treated I'll, let Wayne talk about the study a little bit yes.

I'm sorry.

With respect to timing, usually you will receive minutes from the FDA documenting the conversation and the findings within about 30 days of...

Yes, so with respect to the study.

As was mentioned the Ft 596 protocol allows for a lot of different options with respect to the.

Dosing schedule right. So.

Okay.

So currently we're initiating a dose cohort, where we are administering FTE $5 96 at $1 8 billion cells per dose administered twice in the cycle.

And then I guess you'll wait for the minutes to advise us of what's next.

And once we clear that then the plan will be to further.

Go in different directions, with respect to dosing schedule optimization, including the possibility of further dose escalation as well as giving more doses I E. Three doses in a given treatment cycle. So that's in the relapsed refractory setting that's in the relapsed refractory setting and the rest in the frontline setting in the frontline setting, it's a little bit different.

Because we are giving a single dose of <unk> 596, following a standard cycle of R. Chop so as.

As far as like data availability, if it all depends on how quickly we can enroll just knowing the fact that I'm getting.

Getting initial responses will take some time just based on what we have for protocol. So as soon as we have that data we will obviously be sharing that with you.

Okay. Thank you very much.

Thank you. Your next question is coming from Michael Schmidt of Guggenheim Securities. Michael Please ask your question.

Correct.

I certainly don't want to jump the gun on an FDA discussion.

Yes, of course.

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

Understood.

And then as it relates to the 596 and Rituximab study, the 1.8 billion cell dose cohort, when do you think we can start to see data from that?

I guess first how do you think about the evolving post car T landscape now that.

And what type of data should we expect to be good data based on what you're looking for?

We're starting to see filings for the Bispecific antibodies, which have shown pretty compelling post car T activity.

Sure.

I'll turn it over to Lane to comment on it.

And then maybe building upon that last question I guess as you continue evaluating the higher cell dose as well as multiple cycles for 596, I guess, what gives you confidence that you'll have enough data with enough follow up by year end to determine if this is the go forward asset. Thank you.

With respect to a little bit in terms of what do we think would be good data, I think, again, feasibility that we can give FT596 in combination with RCHOP and with outside fluid would be interesting.

Yeah, absolutely I think your first question I think it is directly on point.

And, again, many of those validation sets of data will be based on translational.

So, for instance, we can continue to look at FT596 and how it performs in the first cycle versus the sixth cycle of RCHOP.

<unk> I think the.

And certainly we can compare that to how FT596 performs from a translational perspective versus side flow, given the number of patients we've treated.

Certainly public around the T cell engages its very encouraging, especially to what is out there today, where there really is no standard of care and.

I'll let Lane talk about the study a little bit.

Yeah.

Response rates are probably in the teens progression free survival and a couple of months is measured in a couple of months. So I do think that T cell engages our potentially absolutely a step forward there in that setting.

We think about target product profile, we're certainly keeping the T cell engages in mind, whether that be in late line patients or actually in earlier line patients, where we also expect the T cell engages to make inroads.

I think given this patient population to be clear I think the durability of response.

Given what is.

I don't want to <unk> standard of care today, what is used today as I mentioned most patients you can see you can measure progression free survival in two to three months and overall survival in five to six months. So I don't necessarily think we need.

A tremendous amount of long term durability data to understand whether we're having an impact with respect to durability of response in these late line patients post car T.

Great. Thanks, and then maybe the second one.

Sorry, what was your second question I apologize yes.

So, with respect to the study, as was mentioned, the FT596 protocol allows for a lot of different options with respect to the dosing schedule, right?

That's okay I had a long question.

I guess, just kind of you know as five nine continues to progress and you're evaluating the higher cell dose and the multiple cycles I guess, what kind of gives you the confidence that you'll have enough data with enough follow up by year end to kind of make that go forward decision with one way or the other.

So, currently we're initiating a dose cohort where we are administering FT596 at 1.8 billion cells per dose administered twice in the cycle.

And once we clear that, then the plan will be to further go in different directions with respect to dose and schedule optimization, including the possibility of further dose escalation, as well as giving more doses, i.e., three doses in a given treatment cycle.

I mean, I think was continuing to subscribe to the fact that especially in aggressive lymphoma that responses happen quickly.

That's in the relapsed refractory setting.

And that's in the relapsed refractory setting.

There is lot of datasets.

Obviously to document that.

In the car T in autologous car T cell land.

In the frontline setting.

We certainly have.

Data from our investigators and we have obviously our own datasets to suggests and continue to reinforce that responses happen quickly. So I think we don't necessarily have to have long term durability to determine whether or not we think the assets are meeting the appropriate target.

The product profile to ultimately be highly competitive.

Got it okay. Thank you so much Scott.

Sure.

Thank you. Your next question is coming from Tyler Van Buren of Cowen Tyler Please ask a.

Question.

Hey, guys. Good afternoon, and thanks very much for the update.

As we think about the update for the year and with $55 six and 596 can you give us a sense of how many patients will have 12 months of follow up.

<unk> cut off and when we think about potential denominator for assessing 12 months CR rate and what do you believe is the minimum bar to be competitive with autologous car T and bi specifics.

And do you think this will be a relatively definitive observation of long term durability for your platform, which I guess you just answered to some extent.

Yeah, I mean, there's.

Five questions in there I mean at some basic level, we do not necessarily expect that we're going to have long term durability data on the high dose cohort given that we're just initiating.

At $1 8 billion cells, whether that be one dose to dose or three doses. So relatively speaking at the high dose cohorts. We think the data will still be emerging at those at those higher doses.

How we compete with T cell engages our car T cell therapy, I think it really depends on the setting.

I don't think patient derived car T cell therapy is a line of therapy post car T. So I don't think that is something you are competing with post car T. T cell engages absolutely I think T cell engagement will be used post car T. So I think that is a force of competition in terms of earlier line usage I do not believe that.

Autologous car T cell therapy or.

Even cell therapies that significantly rely on site flu will be broadly utilized in early line therapy in that community. Although I again once again I do think T cell engagement will be used there. So I think in the earlier line settings, I think T cell engagement are a competitive force.

At Memorial Sloan Kettering as an MD Anderson's absolutely autologous car T cell therapy as a bar.

That said I believe there still continues to be.

At for instance, those specialized centers.

Significant number of patients that do not pursue autologous car T cell therapies for a number of reasons.

And that I do think provides an opportunity even at those specialized centers for folks developing allogeneic off the shelf solutions.

Okay, I assume it might be tie this question's answer okay.

Yes, great question. Please.

Thank you.

Your next question is coming from Yigal.

<unk> from Citigroup.

T.

This was also a embarks on for Yigal. Thanks for taking my questions I guess, maybe thinking about the slow slightly broader perspective.

Brian So let me just start and I'm moving into the second line in Bcl.

Given the success of the Transformers Zuma trials does that change your thinking in terms of the commercial strategy.

In the frontline setting, it's a little bit different because we're giving a single dose of FT596 following a standard cycle of RCHOP.

As far as data availability, it all depends on how quickly we can enroll, just knowing, the fact that getting initial responses will take some time, just based on what we have for protocol.

As soon as we have that data, we will obviously be sharing that with you.

Of course, we know Youre, starting with the post COVID-19 car T setting but.

Thank you very much.

Thank you.

Your next question is coming from Michael Schmidt of Guggenheim Securities.

As youre thinking about the frontline setting.

So maybe you think at some point as a cartoon with higher Youll have to do some type of head to head.

Studying with the card fees with either <unk> or five months.

I think longer term certainly that's a possibility although I do think quite honestly, while there was a study certainly run in a second line setting I continue to believe that post car T cell therapy will have substantial challenges moving into the second line in the community setting and.

So as we think about the landscape we tend to think about it in three buckets. We tend to think about the community setting we tend to think about the specialized centers and we tend to think about patients that are very late line post car T cell therapy, I think as I sort of just discussed I think post car T cells post CD 19 car T cell therapy.

I think the landscape.

Ah patient outcomes are fairly dismal, although again I think we've just recently seen T cell engaging show some promising responses post car T I.

In the early line settings, I continue to believe that the standard chemo immunotherapy regimens that are used and have been used over the course of the years will continue to be the backbone in treating patients early in the community setting and our strategy is to simply add.

Cell therapy without side flu onto those regimens and we believe that that is a winning strategy compared to psi fluid plus car T.

Okay got it and then maybe one follow up I know you'll be speaking with the FDA later this quarter, but but is there a sense that youre still.

Is there something that you will still need to conduct a single arm study in B cell lymphoma.

<unk> posted an unnamed car T setting where do you think.

There's still really open to debate.

Yes.

Well, we certainly know that with more more definitive view and the <unk>.

A couple of months I believe if I look at the landscape generally.

<unk>.

Late line cancer salvage setting I do believe that the FDA will be open, albeit it may be an accelerated approval I do believe the FDA will be open to a single arm study.

Okay got it thank you very much.

Sure.

Michael, please ask your question.

Thank you. Your next question is coming from Michael <unk> of Jeffries, Michael Please ask your question.

Hey, this is Kelsey on for Michael.

Thanks for taking our question.

Hey, Thanks, Good afternoon, Hey, Scott.

Pivoting away from lymphoma for a moment can.

I guess first, how do you think about the evolving post-CUR-T landscape now that, you, know, we're starting to see filings for the bispecific antibodies, which have shown, you know, pretty compelling post-CUR-T activity?

Can you just remind us.

It sounds like you will give an update on solid tumors.

Round 50.

Whether that would be mostly 538 with the ongoing three antibodies and how to put that into context.

536, Mega EPS just early so I presume nothing there. So maybe just talk a little bit about 538, or what we would get there and then with myeloma.

I understand that huge market and certainly.

Similar to push car.

In 19, Theres, a push the CMA market, so with five three and $5 76 ongoing how do you think about.

Whats man there given our PCM has a bar, but maybe also just push the CMA and what do we have data there to give us some picture at the end of the year.

And then maybe building upon that last question, I guess, as you continue evaluating the higher, cell dose, as well as multiple cycles for 596, I guess, what gives you confidence that you'll have enough data with enough follow-up by your end to determine if this, you know, is the go-forward asset?

Thank you.

Sure Yeah I think.

I'll take your last question first I think the multiple myeloma market and our strategy will be very similar to what has played out so far in lymphoma.

So with both $5 38, and $5 seven six I mean, certainly we are getting patients that have been previously treated with the CMA targeted therapies and I do believe there will be an opportunity to rapidly advance our product candidates.

Towards or in a registrational pathway, where you are treating patients that for instance, a post car T cell therapy, the CMA targeted therapy.

Very similar to for instance, the strategy in lymphoma post COVID-19, our T cell therapy.

So I think that opportunity will exist.

Again, I do think.

Our strategy again will be very similar we will look to take for instance, FTE $5 76, given that it can combine designed the combined with our two mab, which is used early and often we do believe there are some foundational synergies with dark and lab that we will be able to move this product candidate in to early lines.

Therapy and treat patients in the community where car T cell therapy understanding there's been studies run certainly may have difficult in actuality, reaching large numbers of patients. So I think the multiple myeloma strategy will play out very similarly to lymphoma, just in terms of how we're seeing the landscape today in terms.

<unk> I think we are going to take the opportunity to showcase the solid tumor franchise broadly.

That will certainly include clinical data with <unk> three eight, albeit early were still earlier in dose escalation with ft. Five six to the extent, we havent really clinical data I'm actually happy to talk about early clinical data with up to five to six it's a very novel car product novel targeting strategy.

We will certainly take the opportunity to discuss innovation as well as collaboration product candidates that are emerging so I expect us to give us a full update on our solid tumor franchise, which will include clinical as well as preclinical as well as collaboration candidates that are emerging.

Perfect and just to clarify your comment on myeloma.

<unk> does set a high bar in the later line. So if you do have patients post CMA similar to what we're talking about in lymphoma or <unk>.

That that would be a compelling deal.

Yeah, absolutely.

Yeah, absolutely and this is why I think FTE $5 76, like FTE five 960 as differentiated right at some basic level. We are we have built products in lymphoma, and myeloma that are designed to synergize with monoclonal antibody therapy, and they're designed to enable multi antigen targeting and with respect to $20.

I think your first question, I think, is directly on point.

Lymphoma, and certain CD 38 in myeloma, they tend to be more durably.

<unk> targets as well.

Absolutely.

I think the, whether it be lymphoma, post-CUR-T cell, or more broadly, obviously, it's a dynamic, landscape.

Thanks.

Okay.

And so, when we've looked at the data that's certainly public around the T cell engagers, it's very encouraging, especially to what is out there today, where there really is no standard of care, and response rates are probably in the teens, progression-free survival is in a couple months, is measured in a couple months. So, I do think the T cell engagers are potentially absolutely a step forward there in that setting.

Thank you very much. Our next question is coming from Peter Lawson of Barclays. Please ask your question.

And I think, you know, when we think about target product profile, we're certainly keeping, the T cell engagers in mind, whether that be in late-line patients or actually in earlier-line patients, where we also expect the T cell engagers to make inroads.

I think, given this patient population, to be clear, I think the durability of response, given what is, I don't want to say standard of care today, what is used today, as I mentioned, most patients, you can measure progression-free survival in two to three months, and overall survival in five to six months.

So, I don't necessarily think we need a tremendous amount of long-term durability data to understand, whether we're having an impact with respect to durability of response in these late-line patients, post-CUR-T.

Hi, This is Jay on for Peter Thanks for taking the question.

The ash update that you've mentioned should we still be thinking that there was an update around the summer time, such as August for 565 96.

And would you be including an update on the outcomes aren't that meeting at this time or would it be too soon and I just have a quick follow up after that.

So it would be very difficult for us to provide an arm that discussion in August .

Meeting I think is scheduled wells scheduled for the third quarter, we will certainly wait for minutes to come back from the FDA before having and fully digesting the update of that regulatory discussion I think our plans are to provide a comp at this point is to provide a comprehensive update on our.

Development strategy in lymphoma, with respect to our NK cells and to provide a comprehensive update we certainly would like the regulatory feedback we're expecting to get obviously data at higher dose levels and three dose cohorts and on.

On the manufacturing pillar be in a position to be in a position to have launched.

Production of clinical.

Pivotal product. So I think we're looking to do a comprehensive update we won't do it in the August .

But certainly looking to do that within the next six months.

Okay, and it's just a more comprehensive picture and maybe around.

<unk> timeframe.

And then right.

<unk> is an <unk>, how should we be thinking of whether that pivotal study in post car T patients potentially could start by year end or should we be thinking thats more likely a first half event and it's five six still on the table along with 516.

Yes, So I think we're going to continue and we'll have the discussion with the FDA with respect to the franchise will continue to generate more data with 516 596, we'll obviously be able to be in position to make a decision on a product candidate I suspect the product candidate, we will be advancing will be a multi antigen targeted prada.

Canada I E. Ft 596, as we think that has broad applicability throughout the lines of care in lymphoma.

Okay, Great. That's helpful color. Thank you and so I imagine this dialogue with the FDA around 596 beyond this.

To be fair most of the.

The conversation agenda discussion points are agnostic to product candidate.

Okay. That's great. Thank you I appreciate it sure.

Thank you. Your next question is coming from Nick Abbott of Wells Fargo. Nick Please ask your question.

Great.

Thanks.

And then maybe the second one.

Sorry, I was just having a question.

Hey, guys. This is James on for Nick just two quick ones from our end.

Will there be an update for 538 ml program on top of the solid tumor program by the end of this year and then.

Number two I'm not sure how much you can say about the short line losses, but is there any idea of when this could be resolved or when we could hear an update.

And the last question is easy I'm not going to comment on.

Intellectual property litigation other than to say, we believe we have foundational intellectual property related to Ips cell technology that can be broadly applied in the field and more specifically to NK cell and T cell cancer immunotherapy.

With respect to FTE 538 in AML.

We are dosing at the highest dose level at least currently allowed under the protocol at $1 5 billion cells multiple doses three doses in a cycle and yes. We believe it can be in a position to provide an update on FTE $5 38 in relapsed refractory AML ash.

Thank you guys.

I apologize.

Sure.

Thank you. Your next question is coming from Matt Biegler from Oppenheimer. Please ask your question.

Yeah.

Hey, Scott Thanks for the color on just a question on the car T failure treatment setting it sounds like youre defining it as both relapse <unk> refractory.

We've seen really good remissions induced in the relapsed setting, but can you just kind of remind us where we're at with refractory have we seen any efficacy there. Thanks.

So.

I think the data that we've reported to date in the patients that are more refractory we have seen less success than the patients that for instance have previously responded.

I think it's too.

Still relatively speaking smaller datasets, where we would make a clear distinction between relapse versus refractory.

Most of our datasets to date that we've disclosed publicly have been at lower doses and using only a single dose regimen. Obviously, we're now getting to the point, where we're at higher doses multi dose regimens and significantly increasing the sell load during the first two weeks.

Got it so at Ash I think it's I think it's I think it would be premature today for us too.

For instance solely select patients that are relapsed.

Gotcha, Okay makes sense. Thanks.

That's okay.

Thank you. Your next question is coming from Dana.

From SBB Securities. Please ask your question.

I had a long question.

I guess, just kind of, you know, as 596 continues to progress and you're evaluating the higher, cell dose and the multiple cycles, I guess, what kind of gives you the confidence that you'll have enough data with enough follow-up by your end to kind of make that go-forward decision with one or the other?

Hi, Thank you further questions first one two questions one on R. Chop.

Wonder if you can talk about the unique biological impact of chop chemotherapy versus <unk> and why you think it could be a good conditioning regimen for FG $5 96 in particular versus other cell therapy.

And the second question on that is why go with one dose.

<unk> hundred 90, <unk> with R. Chop before you get all the data for the multiple doses in the relapsed refractory setting.

Yeah.

Okay. So I'll, let <unk> chime in when I missed some stuff, which I will say that the last question. Let me just clear up any confusion. So as you know a shop cycle is 21 days right and so we are giving a single dose within each cycle.

So, I mean, I think we continue to subscribe to the fact that, especially in aggressive, lymphoma, that responses happen quickly.

There are a lot of data sets obviously to document that in autologous CAR T cell land.

We certainly have data from our investigators and we have obviously our own data sets to, suggest and continue to reinforce that responses happen quickly.

So I think we don't necessarily have to have long-term durability to determine whether, or not we think the assets are meeting the appropriate target product profile to ultimately be highly competitive.

And so for instance, chop as skirt is delivered over typically the first five days in a cycle.

Got it.

Okay.

And then we will add on FTE $5 96, probably three or four days after that so think about day to day 10.

Thank you so much, Scott.

We are moving into frontline patients and in all seriousness I think it is prudent for us in these frontline patients to start with a single dose for each cycle that does not mean that we can't increase cellular load either through dose escalation or multiple doses in <unk>.

Sure.

But given the frontline patients and given the history of these patients I think starting out with a single dose in a cycle does makes sense and keep in mind, we have historically seen to date, even at lower doses single dose a persistence profile of ft, 596 of approximately 14 days, which fits that.

Every night, we're so single dose would fit very nicely into a 21 day cycle as an example.

With respect to R chop.

I think that I think this is the interesting thing about this we don't know cell therapy has has historically relied on site flu as a conditioning regimen. The biological sort of mechanism of action of <unk> flu I think is probably multi factorial I tend to think it has to do with a slight decline spike.

That potentiate cells and reduces the competitive forces that come from the patients immune cells for those cytokines with respect to R. Chop I think the question is going to dig is that cytokine spike with art shop comparable to site flu.

And we will I think we will get to be able to get a very good sense of that very early on.

With respect to the translational data keep in mind, one benefit and unique benefit of FTE $5 six compared to any other cell therapies that have potentially try to do this in the past and I can't think of one off the top of my head FTE 596 has the benefit of twofold number one.

Is the IL 15 receptor fusion. So it has its own fueling mechanism such that it is less dependent on size level and number two it is designed to synergize with Rituximab, which obviously will act as a potential leading signal as well.

When do you have any comments on R chop versus no other than I.

I think it's an important question to address right and which is why we feel it's an important study to conduct right and even even with food side I would just point out that there is a lot of heterogeneity with respect to the doses of <unk>.

Die even in the multiply relapsed refractory setting so.

I think the bank question, we wanted to address is is <unk>.

Our other chemotherapy regimens, such as chop sufficient to support I N K functional persistence and that's what we aim to do in this study.

There is not necessarily with R. Chop do I think it's been demonstrated but I think with for instance, Bendamustine I think it's been clearly demonstrated that you can replace for instance, I flew with Bendamustine in lymphoma.

There's a lot of data out there.

And there's data that I'm aware of that I do believe it's published yet but it is going to reinforce that for instance, bendamustine can be used very effectively instead of site flu.

Thank you.

Your next question is coming from Tyler Van Buren of Cowen.

Yes.

Tyler, please ask your question.

Great. Thank you.

So I think I think the potential to plug in to standard chemotherapy regimens in early line in the community setting.

I think is where the field of cell therapy needs to drive.

Hey, guys.

Good afternoon and thanks very much for the update.

Thank you. Your next question is coming from Robin <unk> from <unk> Securities Robin. Please ask your question.

As we think about the update at the year-end with FT516 and 596, can you give us a sense, of how many patients will have 12 months of follow-up by the ASH cutoff and when we think about potential denominator for assessing a 12-month CR rate and what do you believe is the minimum bar to be competitive with autologous CAR T and by specifics?

And do you think this will be a relatively definitive observation of long-term durability, for your platform, which I guess you just answered to some extent?

Yeah.

Alright, Hi, Scott. Thanks for taking my question I just have a few and these are really simple clarification.

I mean, there's five questions in there.

Regarding data readout, you said you wanted to have a comprehensive data read out in the next six months, but I.

I think you also said we will have data at Ash can you just give more clarity or we for sure going to have data.

I think that 596% at least at higher doses like $900 million, even at the top dose at ash or are you thinking that essentially well some data and then a more comprehensive read out a little bit later I'm just trying to understand the cadence of data.

I'm going to provide really easy we're going to provide our goal is to provide a comprehensive update whether that takes place at ash as part of the formal Ash conference whether that takes place at an investor event at ash or whether that takes place for instance in January we want to provide a call.

I mean, at some basic level, we do not necessarily expect that we're going to have long-term, durability data on the high-dose cohorts given that we're just initiating at 1.8 billion cells, whether that be one dose, two dose, or three doses.

So relatively speaking, at the high-dose cohorts, we think the data will still be, emerging at those higher doses.

How we compete with T cell engagers or CAR T cell therapy, I think it really depends, on the setting.

I don't think patient-derived CAR T cell therapy is a line of therapy post-CAR T, so I don't, think that is something you're competing with post-CAR T. T cell engagers, absolutely.

Comprehensive update across the program and that one includes both the regulatory manufacturing and clinical pillars.

I think T cell engagers will be used post-CAR T, so I think that is a force of competition.

In terms of earlier line usage, I do not believe that autologous CAR T cell therapy or even, cell therapy that significantly rely on side-flu will be broadly utilized in early-line therapy in the community.

Although, again, once again, I do think T cell engagers will be used there.

Great and then my second question is I believe that I believe that will happen in the next six months.

Okay.

And then you are having your arm at meeting this quarter would you still be on track for starting a trial by the end of the year or could that be pushed out to early next year.

Certainly going to depend on an arm that discussion.

Okay, and then the last question and what kind of feedback we get from the FDA with respect to our proposed design of the study but.

But I do think at least from a manufacturing perspective, we'll be well positioned to produce pivotal material. The regulatory strategy will come into clarity within the next couple of months and obviously the clinical data will be further elucidated in the next couple of months.

Got it Thats really helpful. And then the last question. This is.

So I think in the earlier-line settings, I think T cell engagers are a competitive, force.

Brian So you said the preclinical data.

ACR in ADR with the trend for delivering a more potent birth of cell therapy to get around and getting around Si is ADR enough or do you have to do more things to create that super first dose height of or high response rate with first on first dose.

At Memorial Sloan-Kettering and MD Anderson, absolutely, autologous CAR T cell therapy, is a bar. That said, I believe there still continues to be at, for instance, those specialized, centers, a significant number of patients that do not receive autologous CAR T cell therapies for a number of reasons.

Cell therapy, I guess to your question as ADR I got from what else do you think we need to see or do to actually get yourself at that.

And that, I do think, provides an opportunity, even at those specialized centers, for folks, developing allogeneic and off-the-shelf solutions.

To be clear I mean, we're investing in innovation. So as an example, we just had a discussion around <unk> 596, plus R. Chop.

Okay, I think that might be Tyler's questions answered.

Is that okay?

Yes.

Again, we have to run the experiment art shop may be sufficient in potentiate FTE 596.

There are no questions.

Brilliant, thank you.

We have to run that experiment that said I mean, we want to continue investing innovation I do think with an NK cell.

Your next question is coming from Yigal Nochomovitz from Citigroup.

Yigal, over to you.

Hey, Sal the trick with NK cells are shown on the Michigan with NK cells is to continue to focus on the potentiation signals that essentially induce activity on the cells. I also think as we've been having a conversation obviously.

Hi, this is Ashiq Mubarack for Yigal.

Thanks, for taking my questions.

I guess maybe thinking about this from a slightly broader perspective, with Brianzi and Yaskarta now moving into the second line in BCL, given the success of the TRANSFORM and Zuma trials, does that change your thinking in terms of the commercial strategy?

Of course, we know you're starting with the post-CB19 CAR-T setting, but as you're thinking about the front line setting, do you maybe think at some point as the CAR-Ts move higher that you'll have to do some type of head-to-head study with the CAR-Ts with either 5.1.6 or 5.9.6?

I think longer term, certainly that's a possibility, although I do think, you know, quite honestly, while there was a study certainly run in a second-line setting, I continue to believe that post-CAR-T cell therapy will have substantial challenges moving into the second line in the community setting.

Continuing to reduce or eliminate the dependency on site flu is going to be absolutely critical to broad patient utilization, whether thats lymphoma myeloma.

And solid tumors.

And so as we think about the landscape, we tend to think about it in three buckets.

And so I think as we think about continuing to innovate.

We tend to think about the community setting.

We tend to think about the specialized centers.

And we tend to think about patients that are very late-line post-CAR-T cell therapy.

I think, you know, as I sort of just discussed, I think post-CAR-T cell, post-CB19 CAR-T cell therapy, I think the landscape, you know, patient outcomes are fairly dismal, although, again, I think we've just recently seen T cell engagers show some promising responses post-CAR-T.

I think in the early-line settings, I continue to believe that the standard chemo-immunotherapy regimens that are used and have been used over the course of years will continue to be the backbone in treating patients early in the community setting.

Technology for instance, or an approach like ADR, where we think the cells can be absolutely potentiate. It by leveraging an intact immune system is highly differentiating very unique and that technology. If successful would allow cell therapies to be used.

And our strategy is to simply add a cell therapy without PSY-Flu onto those regimens.

And we believe that that is a winning strategy compared to PSY-Flu plus CAR-T.

Okay.

Got it.

Early and often in treating patients whether that be in lymphoma, myeloma or solid tumors.

Great. Thanks, Scott.

Sure.

And then maybe one follow-up.

Thank you. Your next question is coming from Mara Goldstein from Mizuho.

I know you'll be speaking with the FDA later, this quarter, but is your sense that you still – is your sense that you'll still need to just conduct a single-arm study in B-cell lymphoma for post-CB19 CAR-T setting, or do you think that is still really open to debate?

Your question.

Well, we'll certainly know that with more definitive view in the next couple months.

Hi, this is apart from IRA.

I believe if I look at the landscape generally of late-line cancer salvage setting, I do, believe that the FDA will be open – albeit it may be an accelerated approval – I do believe the FDA will be open to a single-arm study.

Okay.

Got it.

I have a question on Amit on the AMA meeting will you also discussed the CMC.

Thank you very much.

Sure.

Thank you.

Your next question is coming from Michael Yee of Jeffries.

Michael, please ask, your question.

Hey, thanks.

Good afternoon.

Hey, Scott.

Aspect of the product in addition to the clinical discussion and also obviously depending on the outcome.

I guess pivoting away from lymphoma for a moment, can you just remind us, since it sounds like you will give an update on solid tumors around CITSI, whether that would be mostly 538 with the ongoing three antibodies and how to put, that into context?

And it feels like 536 MIC-AB is just early, so I presume nothing there.

Ah the meeting and the possibility of the trials Scott does that do you.

Anticipate a change to that.

The thoughts about cash flow.

'twenty three.

And I have a follow up.

So the army discussion that we're having in the third quarter will include some CMC topics, but one of the benefits of our mat is that you can frequently engage the FDA.

So we may be in a position, where we would like to have a rapid follow on meeting with the FDA.

For instance, more delve more deeply into for instance, some of the CMC questions I would say generally speaking, yes. There are absolutely. Some some CMC questions that we get we want to delve into so for instance, potency assay is something that frequently comes up in the world of cell therapies.

That said keep in mind, we've been working with the FDA over the past three years on CMC manufacturer of Ips derived cell therapy, and so over the course of the past three years, we've had lots of interaction quite frankly with the FDA on CMC and we actually bill.

We've we're in a pretty good position with respect to CMC for Ips derived NK and T cell product candidates given the interaction over the past three years and the multiple <unk> that we have cleared ongoing and over that period of time.

With respect to burn our current burn and projections, obviously do assume we're advancing into pivotal studies.

Got it.

My second question is on.

Mario Myeloma study and it was touched on earlier.

Just curious for the study.

<unk> hundred 76, particularly the combo with <unk>, what studies of what agents should be used as a benchmark I should we think of that in terms of comparing it to.

The Bispecific for example, but can you add some clarity on that.

Yeah again.

As I said, it's a lot I think the the comparator depends on the setting.

So I think if I think that's what matters at the end of the day, it's what line of therapy, you're in what setting of.

Intervention Youre at an academic center are you in a patient DNA.

In community setting are you down line of therapy that has failed I think all of that matters.

Early in dose escalation.

Sure.

We're looking for activity and synergy with Dara tune them.

Activity the current synergy with Argentina.

Got it and lastly at Ash. This year do you anticipate to have like some kind of in person corporate meeting or is it just purely at the conference.

That's TBD.

Okay got it thank you so much.

Okay.

Okay. We don't appear to have any further questions in the queue I will now hand back.

Any for any closing remarks.

So maybe just talk a little bit about 538 or what we would get there.

Perfect.

And then with, myeloma, you could understand that huge market and certainly similar to post-CAR-CD19, there's a post-BCMA market.

So with 538 and 576 ongoing, how do you think about what's needed there given that BCMA is a bar, but maybe also just post-BCMA?

Thank you everyone for your participation today appreciate it to all the great questions be following up very soon.

And would we have data there to give us some picture at the end of the year?

Thanks.

Sure.

Yeah, I think I'll take your last question first.

Thank you very much.

I think the multiple myeloma market, and our strategy will be very similar to what has played out so far in lymphoma.

Your next question is coming from Peter Lawson of Barclays.

So with both 538 and 576, I mean, certainly we are getting patients that have been previously treated with BCMA-targeted therapies.

Peter, please ask your question.

And I do believe there will be an opportunity to rapidly advance a product candidate towards an interregistrational pathway where you are treating patients that, for instance, are post-CAR T-cell therapy, BCMA-targeted therapy. Very similar to, for instance, the strategy in lymphoma post-CD19 for T-cell therapy.

Hi, this is Cheyenne from Peter.

Well.

So I think that opportunity will exist.

Thanks for taking the question.

Again, I do think our strategy, again, will be very, similar.

Ahead of the ASH update that you've mentioned, should we still be thinking that there's an, update around the summertime, such as August, for 516 and 596?

Thank you ladies and gentlemen, this does conclude today's conference call.

Thank you ladies and gentlemen, this does conclude today's conference call. You may disconnect. Your phone lines at this time and have a wonderful day. Thank you for your participation.

We will look to take, for instance, FT576, given that it can combine, designed to combine with daratumab, which is used early and often.

And would you be including an update on the outcomes for the RMET meeting at this time, or would it be too soon?

We do believe there are some foundational synergies with daratumab that we will be able to move this product candidate into early Lyme therapy and treat patients in the community.

And, I just have a quick follow-up after that.

Where CAR T-cell therapy, understanding there's been studies run, certainly may have difficult, in actuality, reaching large numbers of patients.

It will be very difficult for us to provide an RMAT discussion in August.

You may disconnect your phone lines at this time and have a

So I think the multiple myeloma strategy will play out very similarly to lymphoma, just in terms of, how we're seeing the landscape today.

The meeting, I think, is scheduled for the third quarter.

In terms of CITSI, I think we are going to take the opportunity to showcase the solid tumors franchise broadly. That will certainly include clinical data with 538, albeit early.

We will certainly wait for minutes to come back from the FDA before having and fully, digesting the update of that regulatory discussion.

We're still at, you know, earlier in dose escalation with FT536 to the, extent, you know, we have early clinical data.

I think our plans are to provide, at this point, is to provide a comprehensive update, on our development strategy in lymphoma with respect to our NK cells.

I'm actually happy to talk about early clinical data with FT536. It's a very novel product, novel targeting strategy.

To provide a comprehensive update, we certainly would like the regulatory feedback.

And we will certainly take the opportunity to discuss innovation, as well as collaboration product candidates that are emerging.

We're expecting to get, obviously, data at higher dose levels in three-dose cohorts and, on the manufacturing pillar, be in a position to have launched production of a clinical product.

So I expect us at CITSI to give sort of a full update on our solid tumor franchise, which will include clinical, as well as preclinical, as well as collaboration candidates that are emerging.

So, I think we're looking to do a comprehensive update.

Perfect.

We won't do it in August, but certainly looking to do that within the next six months.

And just to clarify your comment on myeloma, you know, BCMA does set a high bar in the later line.

Okay.

So if you do have patients post-BCMA, similar to what we're talking about in lymphoma, if you see CRs there or PRs, that would be compelling to you?

Understood.

Yeah, absolutely.

So, a more comprehensive picture, maybe around a crash update time frame.

And this is why I think FT576, like FT596, is differentiated, right?

And then, given that the RMAT meeting is in 3Q, how should we be thinking of whether the, pivotal study and post-cardiac patient potentially could start by year-end, or should we be thinking that's more likely a first-half event, and is 596 still on the table along with 516?

At some, basic level, we have built products in lymphoma and myeloma that are designed to synergize with monoclonal antibody therapy.

Yeah.

And they're designed to enable multi-antigen targeting.

So, I think, you know, we're going to continue, we'll have the discussion with the FDA with, respect to the franchise.

And with respect to 20 in lymphoma, and certainly CD38 in myeloma, they tend to be more durably expressed targets, as well.

We'll continue to generate more data with 516 and 596.

Thanks.

We'll obviously be able to be in a position to make a decision on a product candidate.

I suspect the product candidate we will be advancing will be a multi-antigen targeted, product candidate, i.e., FT596, as we think that has broad applicability throughout the lines of care in lymphoma.

Okay.

Great.

That's helpful, Tyler.

Thank you.

And so, I imagine there's pan-dialogue with the FDA around 596, beyond this RMAT meeting, for 516.

Yeah.

To be fair, most of the conversation agenda discussion points are agnostic to product, candidates.

Okay.

That's great.

Thank you.

I appreciate it.

Sure.

Thank you.

Your next question is coming from Nick Abbott of Wells Fargo.

Nick, please ask your question.

Hey, guys.

This is James Chin on for Nick.

Just two quick ones from our end.

Will there be an update for 538 AML program on top of the solid tumor program by the end, of this year?

And then, number two, I'm not sure how much you can say about the Shoreline lawsuit, but, is there any idea when this could resolve or when we could hear an update?

The last question is easy.

I'm not going to comment on intellectual property litigation, other than to say we believe we, have foundational intellectual property related to iPS cell technology that can be broadly applied in the field, and more specifically to NK cell and T cell cancer immunotherapy.

With respect to FT538 and AML, we are dosing at the highest dose level, at least currently, allowed under the protocol, at 1.5 billion cells, multiple doses, three doses in a cycle, and yes, we believe we will be in a position to provide an update on FT538 in relapsed refractory AML ash.

Thank you, guys.

Sure.

Thank you.

Your next question is coming from Matt Biegler from Oppenheimer.

Matt, please, ask your question.

Hey, Scott.

Thanks for the color.

Just a question on the CAR-T failure treatment setting. It sounds like you're defining it as both relapse and or refractory.

I know we've seen really good remissions induced in the relapse setting, but can you just kind of remind us where we're at with refractory?

Have we seen any efficacy there?

Thanks.

So I think the data that we've reported to date, in the patients that are more refractory, we have seen less success than the patients that, for instance, have previously responded.

I think it's still relatively speaking smaller data sets where we would make a clear distinction, between relapse versus refractory.

Obviously, most of our data sets to date that we've disclosed publicly have been at lower doses and using only a single dose regimen.

Obviously, we're now getting to the point where we're at higher doses, multi-dose regimens, and significantly increasing the cell load during the first two weeks.

Got it.

So it actually probably...

I think it would be premature today for us to, for instance, solely select patients that, are relapsed.

Got you.

Okay.

Makes sense.

Thanks.

Thank you.

Your next question is coming from Dana Graybosh from SVB Securities.

Dana, please, ask your question.

Hi.

Thank you for the questions.

First one, two questions.

One on RCHOP.

I wonder if you, can talk about the unique biological impact of CHOP chemotherapy versus CyFlu and why you think it could be a good conditioning regimen for FT596 in particular versus other cell therapy.

And the second question on that is why go with one dose of FT596 with RCHOP before you get all the data for the multiple doses in the relapse refractory setting?

Okay.

So I'll let Wayne chime in when I miss some stuff, which I will.

So the last question, let me just clear up any confusion.

So as you know, a CHOP cycle is 21 days, right?

And so we are giving a single dose within each cycle.

And so, you know, for instance, CHOP is delivered over typically the first five days in a cycle.

And then we will add on FT596 probably three or four days after that.

So think about day eight to day ten.

We are moving into frontline patients.

And in all seriousness, I think it is prudent, for us in these frontline patients to start with a single dose for each cycle.

That does not mean that we can't increase cellular load either through dose escalation or multiple doses in RCHOP.

But given the frontline patients and given the history of these patients, I think starting out with a single dose in a cycle does make sense.

And keep in mind, we have historically seen to date even at lower doses, single dose, a persistence profile of FT596 of approximately 14 days, which fits very nicely. So a single dose would fit very nicely into a 21-day cycle as an example.

With respect to R-CHOP, I think this is the interesting thing about this.

We don't know.

Cell therapy has historically relied on CyFlu as a conditioning regimen. The biological sort of mechanism of action in CyFlu, I think, is probably multifactorial.

I tend to think it has to do with a cytokine spike that potentiates cells and reduces the, competitive forces that come from the patient's immune cells for those cytokines.

With respect to R-CHOP, I think the question is going to be, is that cytokine spike with, R-CHOP comparable to CyFlu?

And I think we'll be able to get a very good sense of that very early on with respect to, the translational data.

Keep in mind, one benefit, a unique benefit of FT596 compared to any other cell therapies, that have potentially tried to do this in the past, and I can't think of one off the top of my head, FT596 has the benefit of twofold.

Number one, it has IL-15 receptor fusion, so it has its own fueling mechanism such that, it is less dependent on CyFlu.

And number two, it's designed to synergize with rituximab, which obviously will act as, a potentiating signal as well.

I don't know, Wayne, do you have any comments on R-CHOP versus... No, other than, you know, I think it's an important question to address, right, which, is why we feel it's an important study to conduct, right?

And even, you know, even with flu-Cy, I would just point out that there's a lot of heterogeneity, with respect to the doses of flu and Cy, even in the multiply relapsed refractory setting.

So I think that the main question we want to address is, is our other chemotherapy regimens, such as CHOP sufficient, you know, to support INK function and persistence, and that's what we aim to do in this study.

And I think, you know, there is, not necessarily with R-CHOP do I think it's been demonstrated, but I think with, for instance, bendamustine, I think it's been clearly demonstrated that you can replace, for instance, CyFlu with bendamustine in lymphoma. There's a lot of data out there, and there's data that I'm aware of that I don't believe, is published yet, but it's going to reinforce that, for instance, bendamustine can be used very effectively instead of CyFlu.

Great.

Thank you.

So I think, I think the potential to plug in to standard immunochemotherapy regimens, in early line in the community setting, I think is where the field of cell therapy needs to drive.

Thank you.

Your next question is coming from Robin Karmouskas from Truist Securities.

Robin, please ask your question.

Hi.

Hi, Scott.

Thanks for taking my question.

I just have a few, and these are really simple clarifications.

So just regarding data readout, you said you want to have a comprehensive data readout, in the next six months, but I think you also said we'll have data at ASH.

Can you just give more clarity?

Are we for sure going to have data, I think, on 5, 9, 6, at least, at higher doses, like, 900 million, maybe not the top dose at ASH, or, you know, are you thinking that potentially we'll have some data and then a more comprehensive readout a little bit later?

I'm just trying to understand the cadence of data in the second half of the year.

We're going to provide, actually, that's really easy.

We're going to provide, our goal is to provide a comprehensive update, whether that takes, place at ASH as part of the formal ASH conference, whether that takes place at an investor event at ASH, or whether that takes place, for instance, in January. We want to provide a comprehensive update across the program, and that would include, both the regulatory, manufacturing, and clinical pillars.

I believe that will happen in the next six months.

And then you are having an RMAT meeting this quarter.

Would you still be on track for starting a trial by the end of the year or could that, be pushed out to early next year?

Certainly going to depend on an RMAT discussion.

And then the last question is what kind of feedback we get from the FDA with respect, to our proposed design of a study.

But I do think at least from a manufacturing perspective, we'll be well positioned to produce, pivotal material.

The regulatory strategy will come into clarity within the next couple months.

And obviously the clinical data will be further elucidated in the next couple months.

Got it.

That's really helpful.

And then the last question is more broad.

So you showed the preclinical data, ACR and ADR.

With the trend toward delivering a more potent burst of cell therapy to get around and getting, around flu-psy, is ADR enough or do you have to do more things to create that super first dose, high dose or high response rate on first dose with cell therapy?

So I guess the bigger question is ADR enough or what else do you think we need to see or, do to actually get your cells at that high potency level?

To be clear, I mean, we're investing in innovation.

So as an example, we just had a discussion around FT-596 plus R-CHOP.

Again, we have to run the experiment.

R-CHOP may be sufficient in potentiating FT-596.

We have to run that experiment.

That said, I mean, we want to continue investing in innovation.

I do think with an NK cell, NK cell, the trick with NK cells or sort of the mission with, NK cells is to continue to focus on the potentiation signals that essentially induce activity on these cells.

I also think as we've been having a conversation, obviously, continuing to reduce or eliminate, the dependency on CyFlu is going to be absolutely critical to broad patient utilization, whether that's lymphoma, myeloma, and solid tumors.

And so I think, you know, as we think about continuing to innovate a technology, for instance, or an approach like ADR, where we think that cells can be absolutely potentiated by leveraging an intact immune system, is highly differentiating, very unique, and that technology, if successful, would allow cell therapies to be used early and often in treating patients, whether that be lymphoma, myeloma, or solid tumors.

Great.

Thanks, Scott.

Sure.

Thank you.

Your next question is coming from Mara Goldstein from Mizzou.

Mara, please ask your question.

Hi.

Hi, Mara.

I have a question on AMET, on the AMET meeting.

Will you also discuss the CMC aspect of the product in this year?

to the clinical discussion.

And also, obviously, depending on the outcome of the meeting and the possibility of the trial start, do you anticipate a change to the thoughts about CASH for 2023?

And have a follow-up.

So, the RMAT discussion that we're having, in the third quarter will include some CMC topics, but one of the benefits of RMAT is that you can frequently engage the FDA. So, we may be in a position where we would like to have a rapid follow-on meeting with the FDA to, for instance, delve more deeply into, for instance, some of the CMC questions.

I would say, generally speaking, yes, there are absolutely some CMC questions that, we want to delve into.

So, for instance, potency assay is something that frequently comes up in the world of cell therapies.

That said, keep in mind, we've been working with the FDA over the past three years on CMC manufacture of iPS derived cell therapy.

And so, over the course of the past three years, we've had lots of interaction, quite frankly, with the FDA on CMC. And we actually believe we're in a pretty good position with respect to CMC for iPS derived NK and T cell product candidates, given the interaction over the past three years and the multiple INDs that we have cleared during and over that period of time.

With respect to burn, our current burn and projections obviously do assume we're advancing into pivotal studies.

Got it.

My second question is on the multiple myeloma study.

And it was touched on a little, bit earlier, but I'm just curious for the study of 576, particularly the combo with Zara, what studies or what agents should be used as a benchmark?

Like, should we think of that in terms of comparing it to the bispecific, for example?

Like, can you add some clarity on that?

Yeah, again, I say this a lot.

I think the comparator depends on the setting.

So, I think that's what matters at the end of the day.

It's what line of therapy you're in, what setting of intervention, are you in an academic center, are you in a patient, in a community setting, are you down line of a therapy that has failed?

I think all of that matters.

We're early in dose escalation.

We're looking for activity and synergy with Doratum.

Activity of the car and synergy with Doratum.

Got it.

And lastly, at Ashley's CA, do you, anticipate to have like some kind of in-person COVID meeting or is it just purely at the conference?

It's TBD.

TBD.

Okay, got it.

Thank you so much.

Sure.

Okay.

We don't appear to have any further, questions in the queue.

I will now hand back for any closing remarks.

Perfect.

Thank you everyone for your participation today, appreciate all the great questions, be following up very soon, be well.