Q1 2022 Fate Therapeutics Inc Earnings Call

We will begin the conference momentarily please standby.

Operator: We will begin the conference momentarily, please stand by. Welcome to the Fate Therapeutics first quarter 2022 financial results conference. At this time, all participants are in listen only. Call it being webcasted live, website at fatetherapeutics.com. After the speaker presentations, there will be a question and answer, To ask a question during the session, you will need to press star 1. As a reminder, Paul Puth, I would now.

[music].

Welcome to the fate Therapeutics first quarter 2022 financial results conference call.

This time all participants are in listen only mode. This call is being webcast live on the investors section of <unk> website.

<unk> Therapeutics dotcom after the speaker presentation, there will be a question and answer session to ask a question. During this session you will need to press star one on your telephone.

A reminder, today's call is being recorded I would now like to introduce Scott Walsh co President and CEO of fate therapeutics.

Scott Walsh: Scott Walsh Co. [inaudible] Thank you. Good afternoon, and thanks everyone for joining us for the Fate Therapeutics first quarter 2022 financial results call. 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 Release. In addition, our Form 10-Q for the quarter ended March 31, 22, was filed shortly thereafter and can be found on the Investors section of our website under Financial Information.

Thank you good afternoon, and thanks, everyone for joining us for the fate Therapeutics first 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 Form 10-Q for the quarter ended March 31, 22 was filed shortly thereafter and can be found on the investors section of our website under financial information.

Scott Walsh: Before we begin, I would like to remind everyone that except for statements of historical fact, 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.

Before we begin I would like to remind everyone that except for statements of historical facts. The statements made by management and responses to questions. On this conference call are forward looking statements under the Safe Harbor provisions of the private Securities Litigation Reform Act of 1995.

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

Scott Walsh: Please see the forward-looking statement disclaimer on the company's earnings press release issued after the close of the market today, as well as the risk factors included in our Form 10-Q for the quarter ended March 31, 2022. That was filed with the FCC. 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.

As well as the risk factors included in our Form 10-Q for the quarter ended March 31, 2022 that was filed with the SEC today.

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

Scott Walsh: Except as required by law, Fate Therapeutics disclaims any obligation to update these forward-looking statements, to reflect future information, events, or circumstances. Joining me on today's call are Dr. Wayne Chu, our Chief Medical Officer, Ed Dulac, our Chief Financial Officer, and Dr. Bob Valamehr, our Chief Research and Development, Today, we will highlight the clinical progress we have made during the first few months of 2022 with our off-the-shelf, IPSC-derived NK and T-cell programs for the treatment of cancer, as well as note several key milestones that we are striving to achieve over the next several months across our four disease franchises.

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

Joining me on today's call, our Doctor Wayne Chu, our Chief Medical Officer, and Lark, Our Chief Financial Officer, and Dr. Bob <unk>, Our Chief Research and development Officer.

Scott Walsh: In addition, we continue to advance our collaborations with Janssen and Ono with strong momentum, and we will discuss the upcoming milestones that we have the potential to achieve during 2022 under these collaborations. And finally, we will touch on our continued leadership in innovation and highlight certain preclinical programs and data that we featured at the American Association for Cancer Research in April and that we plan to unveil at the American Society of Gene and Cell Therapy in May.

Today, we will highlight the clinical progress we have made during the first few months of 2022 with our off the shelf Ips derived NK and T cell programs for the treatment of cancer.

Well as note several key milestones that we are striving to achieve over the next several months across our four disease franchises.

In addition, we continue to advance our collaboration with Janssen and Ono with strong momentum and we will discuss the upcoming milestones that we have the potential to achieve during 2022 under these collaborations.

And finally, we will touch on our continued leadership in innovation and highlight certain preclinical programs and data that we featured at the American Association for cancer Research in April and that we plan to unveil at the American Society of gene and cell therapy in May.

I would like to begin today by highlighting our recent progress in advancing our off the shelf Ips derived NK and T cell programs for patients with hematologic malignancies and solid tumors.

Scott Walsh: I would like to begin today by highlighting our recent progress in advancing our off-the-shelf iPSC-derived NK and T-cell programs for patients with hematologic malignancies and solid tumor, In the setting of B-cell lymphoma, we continue to enroll patients with relapsed refractory disease in our FT516 and FT596 phase one studies. With respect to our FT516 program in combination with rituximab, multiple disease-specific expansion cohorts are currently ongoing as we continue to assess a multi-dose, multi-cycle treatment schedule of three once-weekly doses at 900 million cells per dose, with respect to our FT-596 program in combination with rituximab.

In the setting of B cell lymphoma, we continue to enroll patients with relapsed refractory disease, and our F. T 516, and F. T 596 phase one studies.

With respect to our Ft 516 program in combination with Rituximab multiple disease specific expansion cohorts are currently ongoing as we continue to assess a multi dose multi cycle treatment schedule of three once weekly doses at 900 million cells.

Per dose.

With respect to our F. T 596 program in combination with Rituximab.

Scott Walsh: Based on the favorable safety profile we have observed in the single-dose multi-cycle cohort, I am pleased to announce that we have now dose escalated this single-dose multi-cycle cohort to 1.8 billion cells. In addition, we continue to enroll a two-dose multi-cycle cohort at 900 million cells per dose, with FT-596 administered on days 1 and 15, and intend to dose-escalate this two-dose multi-cycle cohort to 1.8 billion cells per day. In addition, we are seeing investigator enthusiasm for our FT-819 program, the first ever T-cell therapy manufactured from a clonal IPSC line to undergo clinical investigation.

Based on the favorable safety profile, we have observed in the single dose multi cycle cohort.

I am pleased to announce that we have now dose escalated this single dose multi cycle cohort to 1.8 billion cells.

In addition, we continue to enroll a two dose multi cycle cohort at 900 million cells per dose with ft 596 administered on days, one and 15.

And intend to dose escalate this two dose multi cycle cohort 218 billion cells per dose.

In addition, we are seeing investigator enthusiasm for our F. T 819 program. The first ever T cell therapy manufactured from a clonal Ips seen line to undergo clinical investigation.

Scott Walsh: The Clonal Master IPSC line for FT819 is created from a single IPSC that has a novel CD19-targeted 1XX car contract, integrated into the T-cell receptor alpha constant locus, ensuring complete biallelic disruption of T-cell receptor expression and promoting uniform CARs. We are pleased to announce that we have now dose-escalated the single-dose cohort to 180 million cells. From $90M.

The clonal Master I P. S. C line for F. T 819 is created from a single I P. S. C that has a novel CD 19 targeted one Xx car construct.

Integrated into the T cell receptor alpha constant logos, ensuring complete biallelic disruption of T cell receptor expression and promoting uniform car expression.

We are pleased to announce that we have now dose escalated the single dose cohort two 180 million cells.

From 90 million cells, we are continuing to backfill the single dose cohort at 90 million cells, which cleared with no dose limiting toxicities and no F. T 819 related grade three or greater adverse events.

Scott Walsh: We are continuing to backfill this single-dose cohort at 90 million cells, which cleared with no dose-limiting toxicities and no FT819-related grade three or greater adverse events. In addition to the single dose. We are also enrolling a multi-dose coach, with FT819 administered on days one, three, and five, and the first patients have been treated in this multi-dose cohort at 30 million cells per dose, as we consider registrational pathways in relapse refractory B-cell lymphoma.

In addition to the single dose cohort, we are also enrolling a multi dose cohort.

With F. T 819 administered on days, one three and five.

And the first patients have been treated in this multi dose cohort at 30 million cells per dose.

As we consider registrational pathways in relapsed refractory B cell lymphoma, we continue to believe a critical unmet need exists for patients who have progressed on multiple lines of therapy, especially CD 19 targeted car T cell therapy.

Scott Walsh: We continue to believe a critical unmet need exists, for patients who have progressed on multiple lines of therapy, especially CD19-targeted CAR T-cell therapy. While autologous CD19-targeted CAR T-cell therapy has led to remarkable improvements in outcomes for relapsed refractory patients, It is important to remember that about 30% of patients are primary refractory to CAR T-cell therapy, and the majority of responding, will ultimately experience disease pressure. Under our FT516RMAT designation... We plan to engage the FDA in the coming weeks, and hold a multidisciplinary meeting to discuss our proposed pivotal study design in patients who have progressed or relapsed following prior treatment with FDA-approved CD19-targeted CAR T-cell therapy. Importantly, no standard therapies are available for these.

While autologous CD 19 targeting car T cell therapy has led to remarkable improvements in outcomes for relapsed refractory patients. It is important to remember that about 30% of patients our primary refractory to car T cell therapy.

And the majority of responding patients will ultimately experience disease progression.

Under our FTE 516, Ormat designation, we plan to engage the FDA in the coming weeks and hold a multi disciplinary meeting to discuss our proposed pivotal study design in patients who have progressed or relapsed following prior treatment with F. D. A approved C D.

19 targeted car T cell therapy.

Importantly, no standard therapies are available for these patients and recent retrospective analysis of real World data presented at the 2021 annual meeting of the American Society of Hematology demonstrate extremely poor treatment outcomes with complete response rates of admin.

Scott Walsh: And recent retrospective analyses of real-world data presented at the 2021 Annual Meeting of the American Society of Hematology demonstrate extremely poor treatment outcomes, with complete response rates of administered therapies ranging from 5% to 25% and overall survival ranging from 5% to 7%. Under our FT-516 RMAT designation, we also plan to discuss with the FDA key CMC topics applicable to our first-of-kind iPSC product, With the operational launch of our second GMP manufacturing facility scheduled for mid-2022, we believe we are well-equipped with the in-house expertise and capabilities to fulfill CMC requirements that are necessary for pivotal trial conduct, VLA submission, and initial commercial launch.

Mr therapies, ranging from 5% to 25%.

And overall survival ranging from five to seven months.

Under our F. T 516 arm at designation, we also plan to discuss with the F. D. A key CMC topics applicable to our first of kind I PSE product platform.

With the operational launch of our second GMP manufacturing facility scheduled for mid 2022, we believe we are well equipped with the in house expertise and capabilities to fulfill CMC requirements that are necessary for pivotal trial conduct BLA submission.

And initial commercial launch.

Scott Walsh: We continue to believe that the post-CAR T-cell setting represents a potential fast market development pathway based on the critical unmet need, and we are working to launch a pivotal study, whether that be with FT516 or FT596, by the end of 2022 for patients with aggressive lymphomas previously treated with autologous CD19-targeted CAR T-cell heroin, 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.

We continue to believe that the post car T cell setting represents a potential fast to market development pathway based on the critical unmet need.

And we are working to launch a pivotal study whether that be with ft, 516, or F. T 596 by the end of 2022 for patients with aggressive lymphomas previously treated with autologous CD 19 targeted car T cell therapy.

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.

Scott Walsh: We believe the delivery of off-the-shelf cell therapies in the community setting.., with outside flu chemotherapy condition, as an add-on to frontline immunochemotherapy regimens, has the potential to transform outcomes for many patients with cancer. To that end, over the past several months, we have worked with investigators and key opinion leaders on a clinical protocol that brings FT-596 into the community setting as an add-on to our treatment. The Standard First Line Immunochemotherapy for Patients with Aggressive Lymphoma.

We believe the delivery of off the shelf cell therapies in the community setting.

Without side fluke chemotherapy conditioning.

As an add on to frontline immuno chemotherapy regimens has the potential to trends out form outcomes for many patients with cancer.

To that end over the past several months, we have worked with investigators and key opinion leaders on our clinical protocol that brings F. T 596 into the community setting as an add on to our shop.

Standard first line chemotherapy for patients with aggressive lymphoma.

Scott Walsh: The proposed treatment schema in patients with newly-diagnosed aggressive lymphomas includes administering up to six doses of FT-597, without PSY-Flu chemotherapy conditions, with one dose of FT-596 administered with each of six standard cycles of ART. In the second quarter of 2022, we plan to submit the FT596 plus RCHOP protocol to the FT596IND and expect to begin treating patients in the second half of 2022 subject to its allowance by the FDA. In the setting of multiple myeloma, we continue to enroll patients with relapsed refractory disease in the dose escalation stage of our FT538 and FT576 phase one studies. With respect to our FT-538 program in combination with DAR2MAB.

Proposed treatment schema in patients with newly diagnosed aggressive lymphomas includes administering up to six doses of F. T 596, without Cy flew chemotherapy conditioning.

With one dose of F. T 596 administered with each of six standard cycles of Archrock.

In the second quarter of 2022, we plan to submit the F. T 596, plus R. Chop protocol to the F. T 596, I M D and expect to begin treating patients in the second half of 2022 subject to its allowance by the FDA.

In the setting of multiple myeloma, we continue to enroll patients with relapsed refractory disease in the dose escalation stage of our F. T 538, and F. T 5768 phase one studies.

With respect to our F. T 538 program in combination with Dara two mab.

Scott Walsh: The multi-dose treatment schedule of three once-weekly doses at 100 million cells per dose, cleared with no dose-limiting toxicities, and enrollment is now ongoing at 300 million cells. In addition, with respect to our FT-576 program, the single-dose cohort as monotherapy at 100 million cells cleared with no dose. And we have now treated the first patients in the single-dose cohort in combination with DARTumab at 100 million cells. We are preparing to initiate multi-dose escalation cohorts with FT576 administered on days one and 15 as monotherapy and in combination with dark, in the setting of AML.

The multi dose treatment schedule of three once weekly doses at 100 million cells per dose cleared with no dose limiting toxicities.

And enrollment is now ongoing at 300 million cells per dose.

In addition, with respect to our F. T 576 program the single dose cohort as mono therapy at 100 million cells cleared with no dose.

And we have now treated the first patients in the single dose cohort in combination with Dara to map at 100 million cells.

We are preparing to initiate multi dose escalation cohorts with ft, five seven and six administered on days, one and 15 as monotherapy and in combination went dark.

In the setting of AML the.

Scott Walsh: The company's Phase I study of FT538, which is designed to assess three once-weekly doses of FT538 as monotherapy in relapsed refractory patients, is currently enrolling patients at 1 billion cells per dose. In addition, an investigator-initiated study of FT538 in combination with the CD38-targeted monoclonal antibody Daratumab, which is designed to assess the therapeutic potential of targeting CD38 positive leukemic blast, is also enrolling patients at one billion cells per dose. Both studies include the potential for further dose escalation.

The company's phase one study of F. T $5 38, which is designed to assess three once weekly doses of up to $5 38, as mono therapy in relapsed refractory patients is currently enrolling patients at 1 billion cells per dose.

In addition, an investigator initiated study of F. T 538 in combination with the CD 38 targeted monoclonal anybody Dara two mab.

Which is designed to assess the therapeutic potential of targeting CD 38 positive leukemic blasts is also enrolling patients at 1 billion cells per dose.

Both studies include the potential for further dose escalation.

Scott Walsh: In the setting of solid tumors, I'm pleased to announce that we are poised to initiate a multi-center phase one clinical trial of FT536, the company's first IPSC-derived CAR and K-Cell program for solid- FT-536 incorporates the company's high-affinity, non-cleavable CD16FC receptor to maximize antibody-dependent cellular cytotoxicity, as well as a CAR targeting the major histocompatibility complex class one related proteins, MYC-A and MYC-B. High expression of MIC-A and MIC-B proteins, which is induced by cellular stress, damage, or transformation, has been reported on many solid tumors, although the protolytic shedding of the alpha-1 and alpha-2 domains of these proteins is recognized as a common tumor escape mechanism.

In the setting of solid tumors I am pleased to announce that we are poised to initiate a multi center phase one clinical trial of F. T 536, the company's first Ips C derived car NK cell program for solid tumors.

F T $5 36 incorporates the company's high affinity non cleavable CD 16 FC receptor to maximize antibody dependent cellular side cytotoxicity.

As well as a car targeting the major histocompatibility complex class one related proteins make a and b.

Hi expression of Makena and make the proteins, which is induced by cellular stress damage. Our transformation has been reported on many solid tumors although.

Although the Proto lytic shedding of the Alpha one and Alpha two domains of these proteins is recognized as a common tumor escape mechanism.

Scott Walsh: The Clonal Master iPSC Bank for FT536 was created from a single iPSC engineered with four functional elements, including the novel CAR, which uniquely targets the alpha-3 domain of McGay-McBee, and is designed to overcome tumor escape mechanisms mediated by loss of MHC class 1 expression and protolytic shedding. We believe the product candidate's novel mechanisms of attack and ability to synergize with monoclonal antibody therapy can drive significantly improved outcomes for patients with solid tumors.

The clonal Master Ips He bank for F. T 536 was created from a single Ips C engineered with four functional elements, including the novel car, which uniquely targets. The alpha three domain of Mackay Mcbee and is designed to overcome tumor escape.

Mechanisms mediated by loss of MHC class, one expression and Proto lytic shedding.

We believe the product candidates novel mechanisms of attack and ability to synergize with monoclonal antibody therapy can drive significantly improved outcomes for patients with solid tumors.

Scott Walsh: We have successfully completed manufacturing, and are conducting final release testing of FT536, and we are working with the study's first clinical site, to initiate first patient enrollment by the end of May. The six-arm clinical study is designed to assess a multi-dose, multi-cycle treatment schedule of FT536 as monotherapy and in combination with monoclonal antibody therapy for advanced solitude.

We have successfully completed manufacturer and are conducting final release testing of F. T 536, and we are working with the studies first clinical sites to initiate first patient enrollment by the end of May.

The six arm clinical study is designed to assess a multi dose multi cycle treatment schedule of F. T 536, as monotherapy and in combination with monoclonal antibody therapy for advanced solid tumors.

Scott Walsh: We look forward to providing clinical updates for our multiplexed-engineered, IPSC-derived NK and T-cell product candidates across our disease franchises in the second half of 2022. 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 product candidates to patients for the treatment of hematologic malignancies and solid tumors, under our collaboration with Janssen. We have now initiated IND-enabling activities for two IPS-derived CAR and K-cell collaboration.

We look forward to providing clinical updates for our multiplexed engineered Ips derived NK and T cell product candidates across our disease franchises in the second half of 2022.

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 product candidates to patients for the treatment of <unk> malignancies and solid tumors.

Under our collaboration with Janssen.

We have now initiated IND, enabling activities for two Ips derived car NK cell collaboration candidates.

Scott Walsh: And we are actively working together with Janssen to prepare and submit IND applications for both of these candidates. For each of these collaboration cabinets, Janssen maintains the option, subject to its payment of an option fee prior to IND submission, to initiate worldwide clinical development. We maintain the right in the U.S. alongside JANET, to co-commercialize and share equally in profits and losses of each collaboration. As a reminder, under our collaboration, Janssen has the right to designate and contribute novel binding domains targeting up to four tumor-associated antibodies. Janssen has now designated and contributed novel binding domains targeting three antigens.

And we are actively working together with Janssen to prepare and submit an A&D applications for both of these candidates.

For each of these collaborations tenets Janssen maintains the option.

Subject to its payment of an option fee prior to IND submission to initiate worldwide clinical development.

We maintain the right in the U S alongside Janssen to co commercialize and share equally in profits and losses of each collaboration candidate.

As a reminder, under our collaboration Janssen has the right to designate and contribute novel binding domains targeting up to four tumor associated antigens.

Janssen has now designated and contributed novel binding domains targeting three antigens.

And we have now successfully achieved preclinical milestones for collaboration candidates targeting all three antigens.

Scott Walsh: And we have now successfully achieved pre-clinical milestones for collaboration candidates targeting all three answers, under our collaboration with Ono. Ono has contributed a novel binding domain targeting a solid tumor-associated antigen, and we have now initiated the generation of the master cell bank for a multiplexed engineered IPS-derived CAR-T cell collaboration candidate targeting the solid tumor-associated antigen. We are poised to initiate IND-enabling activities for this solid-tumor CAR T-cell collaboration candidate during the third quarter of 2022, at which time Ono has the option, subject to its payment of an option fee, to exercise its rights for worldwide clinical development and commercialization, while we maintain the right to co-develop and co-commercialize the CAR T-cell collaboration candidate in the U.S. and Europe alongside us.

Under our collaboration with Ono.

<unk> has contributed a novel binding domain targeting a solid tumor associated antigen and we have now initiated the generation of the master cell bank for a multiplex multiplexed engineered Ips derived car T cell collaboration candidate targeting the solid tumor associated antigen.

We are poised to initiate IND, enabling activities for this solid tumor car T cell collaboration candidate during the third quarter of 2022.

At which time <unk> has the option.

Subject to its payment of an option fee to exercise its rights for worldwide clinical development and commercialization.

While we maintain the right to co develop <unk>.

And co commercialize the car T cell collaboration candidate in the U S and Europe alongside Ono.

Scott Walsh: We are very pleased with the success we have achieved with Janssen and Ono in developing multiplex engineered IPS-derived CAR-NK and CAR-T cell product candidates for both liquid and solid tumors. And we are now poised to achieve significant milestones in connection with option exercise by Janssen and Ono over the course of the next three to six months. Turning to our continued leadership in innovation. We continue to invest in building a first-in-class pipeline of multiplexed engineered product candidates for solid tumors, including through the development and incorporation of new functional elements designed to overcome critical barriers that limit cell therapy, such as the requirement for patient lymphoconditioning. Tumor Antigen Escape, and the Immunosuppressive Tumor Micronvirus.

We are very pleased with the success, we have achieved with Janssen and Ono in developing multiplex engineered Ips derived car NK and car T cell product candidates for both liquid and solid tumors and we are now poised to achieve significant milestones in connection with option exercised by Janssen and Ono.

Over the course of the next three to six months.

Turning to our continued leadership in the innovation.

We continue to invest in building a first in class pipeline of multiplexed engineered product candidates for solid tumors, including through the development and incorporation of new functional elements designed to overcome critical barriers that limit cell therapy <unk>.

Such as the requirement for patient lymphoma conditioning.

Tumor antigen escape and the immuno suppressive tumor microenvironment.

Scott Walsh: At the American Association for Cancer Research in April, we presented our Synthetic Alloimmune Defense Receptor, or ADR, which targets 4-1BB upregulated on host alloreactive immune and is designed to eliminate the need for patient conditioning in administering off-the-shelf cell-based cancer immunotherapy. In preclinical models, we showed that ADR-armed IPS-derived NK cells demonstrate enhanced functional persistence in vitro in the presence of alloreactive NK and T-cells, and exhibit durable anti-tumor activity in vivo in the presence of alloreactive T-cells.

At the American Association for cancer Research in April .

We presented our synthetic allo immune defense receptor or ADR.

Which targets for one be be up regulated on host allo reactive immune cells and is designed to eliminate the need for patient conditioning. It administer an off the shelf cell based cancer immunotherapy.

In preclinical models, we showed that ADR armed Ips derived NK cells demonstrate enhanced functional persistence in vitro in the presence of allo reactive NK and T cells and exhibit durable anti tumor activity in vivo.

In the presence of allo reactive T cells.

Scott Walsh: These preclinical data provide proof of concept that ADR armed cell therapies have the potential to persist, and induce potent anti-tumor activity without requiring a patient to undergo chemotherapy conditioning to deplete the host immune system. In addition, we showcased our novel chimeric CD3 fusion receptor, or CD3FR, which is designed to enable off-the-shelf cell-based cancer immunotherapies to combine and synergize with CD3 by specific engagement. In developing off-the-shelf CAR T-cell therapies, TCR expression must be eliminated to prevent graft-versus-host disease. However, the absence of TCR expression leads to loss of surface CD3 expression. Similarly, NK cells naturally lack TCR expression and have no surface CD3 expression.

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

In addition, we showcased our novel Chimeric CD three fusion receptor or CD three fr.

Which is designed to enable off the shelf cell based cancer immunotherapies to combine and synergize with CD three by specific engages.

In developing off the shelf car T cell therapies, TCR expression must be eliminated to prevent graft versus host disease. However, the absence of TCR expression leads to loss of surface CD three expression.

Similarly, NK cells naturally lack TCR expression and have no surface CD three expression.

Scott Walsh: In preclinical models, we showed that CD3FR-armed IPS-derived CAR T-cells, in combination with a bispecific engager, demonstrate target-specific cytotoxicity in vitro, through CD3FR engagement and enabled dual antigen target. These preclinical data provide proof of concept that, much like our HNCD16FC receptor that enables synergy with monoclonal antibody therapy, our CD3FR enables armed, IPS-derived CAR-NK and CAR-T cells to effectively combine and synergize with CD3 bispecific engagers for a multi-pronged attack on heterogeneous solitude. Later this month... At the American Society of Gene and Cell Therapy, we plan to present nine abstracts, covering our proprietary IPSC product platform, including the unveiling of our most sophisticated multiplexed engineered IPS derived cell product to date.

In preclinical models, we showed that CD three fr armed Ips derived car T cells in combination with a buy specific engage or demonstrate target specific cytotoxicity in vitro.

Through CD three F. Our engagement and enabled dual antigen targeting.

These preclinical data provide proof of concept that much like our H N. CD 16 FC receptor that enables synergy with monoclonal antibody therapy or CD three fr enables armed Ips derived car NK and car T cells to effectively combine and synergize with <unk>.

<unk> three by specific engages for a multipronged attack one heterogeneous solid tumors.

Later this month at.

At the American Society of Gene and cell therapy, we plan to present nine abstracts, covering our proprietary Ips C product platform, including the unveiling of our most sophisticated multiplexed engineered Ips derived cell product to date.

Scott Walsh: We are currently developing an off-the-shelf, IPS-derived CAR T-cell product candidate for solid tumors. That incorporates seven functional modalities, including three modes of tumor targeting to overcome tumor heterogeneity, as well as a novel synthetic CXCR2 homing receptor to promote trafficking to solid tumors, and a novel synthetic TGF-β redirector receptor to promote activation in response to repressive signaling in the tumor microenvironment.

We are currently developing an off the shelf Ips derived car T cell product candidate for solid tumors that incorporates seven functional modalities.

Including three modes of tumor targeting to overcome tumor heterogeneity as well as a novel synthetic <unk> homing receptor to promote traffic into solid tumors.

And a novel synthetic TGF beta redirect or receptor to promote activation in response to repressive signaling in the tumor microenvironment.

Ed Dulac: While we will not yet disclose the CAR constructs solid tumor target. Preclinical data will show that the novel binding domain exhibits unique antigen recognition and tumor selectivity with the ability to discriminate between antigen expressed on tumor cells versus normal tissue. We look forward to advancing our first off-the-shelf, IPS-derived CAR T-cell product candidate for solid tumors into IND-enabling activities later this year. I would now like to turn the call over to Ed to highlight our first quarter financial report.

While we will not yet disclosed the car construct solid tumor targets.

Preclinical data will show that the novel binding domain exhibits unique antigen recognition and tumor selectivity with the ability to discriminate between antigen expressed on tumor cells versus normal tissue.

We look forward to advancing our first off the shelf Ips derived car T cell product candidate for solid tumors into IND, enabling activities later this year.

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

Ed Dulac: Thank you, Scott, and good afternoon. Fate Therapeutics is in a strong financial position to advance our platform and pipeline. Our cash, cash equivalents, and investments at the end of the first quarter of 2022 were approximately $642 million. In the first quarter of this year, our collaboration revenue, derived from our partnerships with Janssen and Ono Pharmaceutical, increased by $7.3 million to $18.4 million, compared to $11.1 million for the same period last year. Research and development expenses for the first quarter increased by $27.3 million to $72.1 million, compared to $44.9 million for the same period last year.

Thank you Scott and good afternoon.

Fate Therapeutics is in a strong financial position to advance our platform and pipeline, our cash cash equivalents and investments at the end of the first quarter of 2022 for approximately $642 million.

Ed Dulac: 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 professional consulting. General and administrative expenses for the first quarter of 2022 increased by $8.2 million to $20.7 million, compared to $12.5 million for the same period last year. The increase in our G&A expenses was attributable primarily to an increase in employee headcount and compensation, including share-based compensation and talent acquisition and facility-related fees. Total operating expenses for the first quarter were $92.9 million, which includes $19.2 million of non-cash, share-based compensation expense.

In the first quarter of this year, our collaboration revenue derived from our partnerships with Janssen and Ono pharmaceutical increased by $7 $3 million to $18 4 million compared to $11 1 million for the same period last year.

Research and development expenses for the first quarter increased by $27 $3 million to $72 1 million compared to $44 9 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 inexpensive associated with R&D fees and third party professional consultants.

General and administrative expenses for the first quarter of 2022 increased by $8 2 million to $20 7 million compared.

Compared to $12 $5 million for the same period last year.

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

Total operating expenses for the first quarter were $92 $9 million, which includes $19 2 million of noncash share based compensation expense.

Ed Dulac: Note that, in connection with the development of our off-the-shelf, IPSC-derived CAR T-cell product candidate, FT819, we previously achieved the clinical milestone set forth in our amended license agreement with Memorial Sloan Kettering Cancer Center, which triggered a first milestone payment to MSK in 2021. Up to two additional milestone payments may be owed to MSK based on subsequent trading values of the company's common stock ranging from $100 to $150 per share. We assess the fair value of these contingent milestone payments currently valued at $15.8 million on a quarterly basis. In the first quarter, we recorded a non-cash $8.4 million non-operating benefit associated with the change in fair value. Our net loss for the first quarter of the year was $65.7 million, or 68 cents per share.

Note that in connection with the development of our off the shelf Ips derived car T cell product candidate S. T 819, we previously achieved the clinical milestone set forth in our amended license agreement with Memorial Sloan Kettering Cancer Center, which triggered a first milestone payment.

To M S K in 2021.

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

We assessed the fair value of these contingent milestone payments currently valued at $15 $8 million on a quarterly basis.

In the first quarter, we recorded a non cash $8 4 million dollar non operating benefit associated with the change in fair value.

Our net loss for the first quarter of the year was $65 7 million or <unk> 68 per share.

Operator: 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 investment. This does not include potential success-based milestone payments from our collaborations with Janssen and Ono Pharmaceutical. I would now like to open the call up to questions. As a reminder, to ask a question, you will need to press star 1. Withdraw your- Stand by while, Our first question comes from Tyler Van Buren with Cowen. Tyler.

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.

I would now like to open the call up to questions.

As a reminder to ask a question you will need to press star one on your telephone.

Your all your question press the pound key.

Please standby.

The Q&A compile the Q&A roster.

Okay.

Our first question comes from Tyler Van Buren with Cowen Tyler Your line is now open.

Tara Bancroft: Hi guys, this is Tara. Um, I was just wondering... You can get an update on when we.., https://centerforautism.com from the Solid Tumor Clinical Program. I think in our prepared remarks, we made a statement that we plan on providing clinical updates across our four disease franchises in the second half of 2022. Okay, well, can I actually ask one more?

Hi, guys. This is tara on for Tyler.

Wondering if we can get an update on when we might expect initial data from the AML multiple myeloma and potentially from the solid tumor clinical programs. This year.

Yes, I think in our prepared remarks, we made a statement that we plan on providing clinical updates across our four.

<unk> disease franchises in the second half of 2022.

Operator: So one thing that you mentioned last, that you, for FT516, you were doing this R-bendo. Combination, and I didn't hear you mention it here, so I was wondering if that was still in the plan, and for the FTE-509, are top. Well, those patients that are now being treated, will they be included potentially in the August update or at? So, I mentioned with respect to the FT-516 study, there are multiple dose expansion cohorts ongoing in the FT-516 study, which would include Arbenda.

Okay, well can I actually ask one more so one thing that you mentioned last quarter was that.

That you for FTE 516, you were doing this our benda.

Combination and I didn't hear you mention it here. So I was wondering if that was still in the plan and for the FTE 5596, plus R. Chop.

Well those patients that are now being treated well will they be included potentially in the August update or at ash.

Operator: With the FT-596 study, we are, Preparing the print clinical protocol for FT-596 plus R-CHOP, to submit to the FDA. And I mentioned, I believe, that we plan on beginning, subject to its clearance, we plan on beginning treating patients in the second half of 2022 with respect to FT596 plus ARCHA. Okay, thanks, from Michael Yee of Jeff. Michael, your line is now.

So I mentioned with respect to the Ft 516 study there are multiple dose expansion cohorts ongoing in the Ft 516 study, which would include our Bender with.

With the Ft 596 study.

We are preparing the clinical protocol for F. T 596, plus our shop to submit to the FDA and I mentioned I believe with that we plan on beginning subject to its clearance we plan on beginning treating patients in the second half of 2022.

With respect to F T 596, plus R chop.

Okay. Thanks.

Our next question comes from Michael <unk> of Jefferies. Your.

Your line is now open.

Michael Yee: Hey Scott, thank you for the update. Any other questions for us? I thought your comments around 819... IPSC CAR-T were pretty interesting, and I guess you've started dosing patients, so maybe you could talk a little bit about how we should expect the bar for you, given other peers out there. I know you'll have, maybe have some data at the end of this year, so how should we think about that data in comparison to others in the bar set there, considering you're probably a low-dose patient?

Hey, Scott Thank you for the update.

Two questions for Us I thought your comments around eight or nine.

S. C car T were pretty interesting and I guess you started dosing patients. So maybe you could talk a little bit about how we should expect.

The bar for you given that other peers out there I know youll have maybe have some data at the end of this year. So how should we think about that data in comparison to others in the bar set there considering you're probably at low doses.

Michael Yee: And then second question is similar, in myeloma as well, there's obviously a bar out there for some pretty compelling drugs, particularly CAR-T. You have a drug, I think, obviously with CD38 and DCMA, so maybe just talk a little bit about how we would expect that efficacy bar and whether patients would or would not have lost some DCMA and would that still work, et cetera, et cetera. Sure.

And then second question is similar.

In myeloma as well, there's obviously a bar out there for some pretty compelling drugs.

Particularly with car T. You have by drug I think obviously with CD 38 M. D. CMA. So maybe just talk a little bit about how we would expect that our.

Efficacy bar and whether patients would or would not have Washington D. C. M. A and would that still work et cetera et cetera. Thank you.

Scott Walsh: So let me start with the myeloma, and then I can move to 819. So with myeloma, I think, again, it's early, but I'm not going to be – I think I've said this before – I'm not going to be surprised if the strategy plays out similarly to how we're pursuing lymphoma, meaning that with FT576, we think, obviously, with its dual antigen targeting potential, it could potentially be used downline of patients who have received, for instance, CAR-T-targeted BCs, BCMA therapy.

Sure. So let me let me start with the myeloma and then I can move to.

<unk> 19, so with myeloma I think again, it's early but I'm not going to be I think I've said this before I'm not going to be surprised if the strategy plays out similarly to how we're pursuing lymphoma, meaning that with ft 576, we think obviously with its dual antigen targeting potential it could potentially be.

Used down line of patients who have received for instance car T targeted D CMA therapy and in fact.

Scott Walsh: And, in fact, in our studies, both with respect to 538 as well as 576, I believe we are – we have treated patients that are, in fact, have previous experience with the CAR-BC – approved CAR-BCMA cell therapy. So, you know, obviously I have to look at the data.

In our studies, both with respect to $5 38, as well as 507 six I believe we are true we have treated patients that are in fact have previous experience with the car Bcf approved carb D. CMA cell therapies. So you know.

We obviously have to look at the data were earlier on inland in myeloma compared to lymphoma, but I do think there potentially in myeloma will be a similar fast to market strategy that may emerge initially down line of the F. D. A approved car be CMA therapies does not mean.

Scott Walsh: We're earlier on in myeloma compared to lymphoma, but I do think there potentially in myeloma will be a similar fast-to-market strategy that may emerge initially down the line of the FDA-approved CAR-BCMA therapies. Does not mean that's the totality of our development path. Obviously, we've developed product candidates that we believe can synergize with DAR2MAP and DAR2MAP is used early and often throughout multiple lines of therapy, but I do think there will potentially be a fast-to-market strategy that evolves in myeloma much like lymphoma. And we're excited about those opportunities as a first opportunity, as a first chance to put a stake in the ground for our product candidates and begin to develop around.

That's the totality of our development path, obviously, we've developed product candidates that we believe can synergize with Dar to mob and Dar to Mab is used early and often throughout multiple lines of therapy, but I do think there will potentially be a fast to market strategy that evolves in myeloma much like lymphoma, and we're excited about those opportunities.

As a first opportunity as our first chance to put a stake in the ground for our product candidates and begin to develop around that.

Scott Walsh: With respect to 819, look, this is our first experience with an IPS-derived CAR T-cell therapy. I mean, this has been long in development over the past, I think we entered into the collaboration with Memorial Sloan Kettering back in 2016 to develop the first ever IPS-derived CAR T-cell therapy. We're here, we're treating patients. Interestingly enough, we started at 90 million cells per dose. And I think if you look at the approved CAR T-cell therapies in DLBCL patients, aggressive lymphomas, the dose that is often given to those patients is probably in the 100 to 200 million cell range.

With respect to 819 I look the start this is our first experience with an Ips derived car T cell therapy I mean this is Ben.

Long in development over the past I think we are.

Entered into the collaboration with Memorial Sloan Kettering back in 2016 to develop the first ever Ips derived car T cell therapy, where here, we're treating patients interestingly enough. We started at a 90 million cells per dose.

Scott Walsh: So in starting at 90 million cells per dose, I'm not suggesting by any means, it's the most efficacious dose, but we are starting at a dose that if we truly do make essentially alpha beta T-cells, you know, we may be starting at dose levels that have the potential to show activity. Yep.

And I think if you look at the approved car T cell therapies in a D L bcl patients aggressive lymphomas.

The dose that is often given to those patients is probably in the 100 to 200 million cell range.

So in starting at 90 million cells per dose.

I'm not suggesting by any means it's the.

F N b.

Most efficacious dose, but we are we are starting at a dose that if we truly do make essentially alpha beta T cells.

We may be starting at dose levels that have the potential to show activity.

Okay.

Yeah.

Sure.

Operator: Thank you. Sure. Our next call. Our next question... Yow, Nochomovitz, with City Cl... Yigal, you're live.

Our next call.

Our next question is from Al <unk> with Citigroup.

Your line is now open.

Yigal Nochomovitz: Yeah. Hi, Scott and team. Thanks for taking the question. I'm just wondering, with regard to the RMAC meeting that's coming up... Please clarify as to why, 8596 does not appear to be part of that discussion, I would have thought that.

Yeah, Hi, Scott and team thanks for taking the question.

Just wondering with regards to the R. Mat meeting that's coming up.

Could you just clarify as to why.

Ft 596 is it does not appear to be part of that discussion I would've thought that.

Scott Walsh: You know, XE-596 would also be a... You know, a useful option in the post-CD19 CAR-T setting for B-cell lymphoma. Sure, so to be clear and clear up any confusion, I absolutely believe that FT596 is applicable down the line of CAR T cell therapy, without a doubt. The RMAT designation is very specific for FT516, so the meeting that we're planning is specific to FT516, it was granted, the RMAT designation was granted to FT516. That said...

<unk> hundred 96 would also be.

Useful option in the post CD 19 car T setting for B cell lymphoma.

Sure so to be clear and clear up any confusion I absolutely believe ft 596 is applicable down line of car T cell therapy without a doubt the arm that designation is very specific for F. T. $5 16. So the meeting that we're planning is specific to ft 516. It was grant the army designate.

<unk> was granted to ft 516 that said.

Scott Walsh: Many of the topics we will be covering, whether it relates to clinical study design, endpoints, CMC, are applicable to FT5-9. And so, what we plan on discussing with respect to the RMAT discussion with the upcoming RMAT discussion really is more agnostic to product chemistry. What is the clinical study design? What are endpoints?

Many of the topics, we will be covering.

Whether it relates to clinical study design endpoints CMC.

Our.

Applicable to F T 596.

And so what we plan on discussing with respect to the arm at discussion with that too.

With the upcoming or Matt discussion really is more agnostic to product candidate what is the clinical study design. What are end points. We have a proposed study design that we would like to review with the FDA. There are CMC issues that are unique to Ips derived cell therapies that we also plan on discussing with the FDA. So we while.

Scott Walsh: We have a proposed study design that we would like to review with the FDA. There are CMC issues that are unique to iPS-derived cell therapies that we also plan on discussing with the FDA. So while this meeting is specific for 516, we do believe the output of that meeting will be highly applicable to FT596. And ultimately, as we progress into the second half of 2022, we will make a decision with respect to FT-516 or FT-596 for conduct of the pivotal. Got it.

This meeting is specific for $5 16, we do believe the output of that meeting will be highly applicable to ft 596, and ultimately as we progress into the second half of 2022, we will make a decision with respect to ft 516 or F. T five nine.

Six for conduct of the pivotal study.

Scott Walsh: Okay, that's that's super helpful. And then I just had a question on on FT-596 plus rituximab and the new dosing regimens that you're rolling out. So just curious, you know, based on everything, you know about 596, NK cell biology and NK cell, I'm just wondering, asking you to speculate, which do you think would be more effective, the single dose 1.8 billion or the multi-dose 900 million given twice? which do you believe is likely to be superior or do you think they could just end up being very similar?

Got it Okay. That's super helpful.

And then I just had a question on Ft, 596, plus rituximab and the new dosing regimens that you're rolling out.

So just curious based on everything you know about 596, NK cell biology, and NK cell persistence, just wondering asking you to speculate which do you think would be more effective the single dose $1 8 billion or the multi dose $900 million given twice.

Which do you believe this is likely to be superior or do you think they can just end up being very similar.

Scott Walsh: So I think I've always been on record saying that I think the right schedule for treating patients with NK cells very likely includes multiple doses, and I still believe that, today. So I do believe when delivering an NK cell, given their relatively short persistence compared to a T cell, And given they are significantly less prone to expand and proliferate as compared to a T-cell, I fundamentally believe a multi-dose schedule for an NK cell is going to be the most efficacious bet.

So I think I've always been on record, saying that I think the right.

Schedule for treating patients with NK cells, very likely includes multiple doses and I still believe that.

Today, So I do believe when delivering an NK cell given their relatively short persistence compared to a T cell.

And given there they are less significantly less prone to expand and proliferate as compared to a T cell I fundamentally believe a multi dose schedule for an NK cell is going to be the most efficacious pass that and to be clear.

Scott Walsh: And to be clear, we are delivering multiple doses at 900 million cells per dose. We're also delivering a single dose at 1.8 billion. Both pathways enable us, the clearance of those pathways enable us to get to 1.8 billion times two, day one and day 15, and that's where we're headed.

Here, we are delivering multiple doses at 900 million cells per dose.

We're also delivering a single dose at 1.8 million sorry billion both pathways provide.

<unk> enable us the clearance of those pathways enable us to get to one 8 billion times two day, one and day 15, and that's where we're headed.

Scott Walsh: And then if I could just throw in one more on myeloma. Sure. So obviously you've done a lot of great work building a cell therapy. How much consideration have you given to potential combinations with other standard of care agents in myeloma, for instance Imbeds or proteasome inhibitors? We've done some pre we've done some pre clinical work in assessing other combinations. But you are correct. I mean, the driver with respect to the therapeutic design, of both FT538 or 576 was really about creating a cell type that could uniquely synergize with Daratumumab, given the concern with respect to fratricide.

Gotcha Okay.

And then if I could just throw in one more on myeloma. So obviously you've done a lot of great work.

Building on building a cell therapy that can function in combination with <unk> given that the CD 38 knockout just wondering how much consideration have you guys given to <unk>.

Central combinations with other standard of care agents myeloma for instance, embeds or Proteasome inhibitors.

So we've done some pre we've done some preclinical work in assessing other combinations.

But you are correct I mean, the driver with respect to the therapeutic design.

Oh, both at 538 or $5 76 was really about creating a cell type that could uniquely synergize with Dara two mab given the concern with respect to fratricide obviously.

Scott Walsh: Obviously activated NK cells, activated T cells, expressed CD38, and so there was the potential for fratricide. We always thought there would be significant opportunity to synergize with Darzalex. We've certainly done doing preclinical experiment to understand how our product candidate could plug into existing regimens that include Darzalex, which, as you've alluded to, includes some of these IMIDs as an example. And so we don't think, we haven't seen anything to suggest that those other agents that are part of combination therapies would be detrimental to cells in any way. Understood. Thanks, Scott. Sure. Daina Graybosch, Daina, you have- Hi, thank you for the questions. I think a couple for me.

Activated NK cells activated T cells Express CD 38, and so there was the potential for fratricide.

Always thought there would be significant opportunity to synergize with doors lax, which certainly are done doing preclinical experiments to understand how our product candidate could plug into existing regimens.

That include doors, Lex, which as you've alluded to include some of these <unk> as an example, and so we don't think we haven't seen anything to suggest that those other agents that are part of combination therapies would be detrimental to solve in any way.

Understood. Thanks, Scott.

Sure.

Our next question is from Dana.

SBB securities gain or you have to play.

Hi, Thank you for the questions a couple for me one what talking so much about.

Daina Graybosch: One, you know, we're talking so much about dose, you know, 900 million, 1.8 billion cells. I wonder whether you could help put that into context. How many NK cells are circulating in an average patient or healthy human, and how does that compare to, let's say, 900 or 1.8 billion cells? Sure. Bob or Wayne, do you want to address that question if you're, we're not in the same room, but either one of you? Sure, I could start. We typically have somewhere between $1 to $2 billion.

900 million $1 8 billion pounds.

Or whether you could help put that into context.

How many NK cells are circulating in the average patient unhealthy human.

And how does that compare to let's say 900, or a $1 8 billion.

<unk>.

Sure.

Bob or when do you want to address that question.

We're not in the same room, but are either one of you.

Sure I can start we typically have somewhere between $1 billion to $2 billion. So we're here with each dose at those high doses are reconstituted and to that.

Wayne Chu: So we're here with each dose at those high doses are reconstituting the NK compartment of a normal patient. Okay, that's an easy answer. Thank you very much. The second one for multiple myeloma, I wonder if you could talk a bit more about your binder for BCNA. I think you've called it avidity-like, and I wonder if you could talk about what gives you confidence that your binder will give the same effect as avidity that's been used successfully. B.C.M.A.K.

The NK compartment.

And normal patient.

Okay. That's an easy answer thank you very much.

The second one for multiple myeloma myeloma I Wonder if you could talk a bit more about your binder for BCS. Thank you called it as they did the like and I Wonder if you could talk about what gives you confidence that youre binder will get the same effect as well.

<unk>, that's being used successfully.

Be CMA car T.

Scott Walsh: Sure, I think, again, either Bob or Wayne, Bob, you want to address that question as I think you're most familiar with the unique characteristics of our particular binder. Sure. So the binder was well characterized in a molecular therapy article back in 2018 by Armand Rem. And so there he shows that the affinity of the binder allows the preclinical studies to target cells that had less than 1,000 BCMA per cell. So he was able to target BCMA per cell in the 100 range. But that gave us confidence that this binder is going to be unique.

Sure I think God again, either Bob or waned, Bob do you want to address that question is I think youre most familiar with the unique characteristics of our particular binder.

Sure. So the binder was well characterized in molecular therapy article back in 2018 by arm and ramp and so there he shows that the affinity of the binder allows the.

The preclinical studies to target cells that had less than a thousand CMA per cell. So he was able to target.

The CMA per sell into 100 range, but that gave us confidence that this binder is gonna be unique we've compared it to two.

Bob Valamehr: We've compared to the competitors where we have access to the sequence, and it does outperform. So Armand's initial work and some of our preclinical work suggests that this binder is going to be of higher quality, higher affinity, and hopefully gives us better results. Great, thank you very much. Our next question is from Nick Abbott with Wells Fargo. Nick, your line is open.

Our competitors, where we have access to the sequence and it does outperform so.

Arm is initial work in some of our preclinical work suggest that this fine there it's going to be.

Of higher quality higher avidity, and hopefully gives us better results and outcome.

Great. Thank you very much.

Our next question is from Nick Abbott with Wells Fargo. Your line is now open.

Nick Abbott: Trivik, thank you very much for taking my questions. I'd really like to apologize if maybe you addressed this, but maybe starting off with 516 and R-Met. You know, that IND was approved several years ago, and notwithstanding the fact you've had several INDs approved since, things like FDA getting more focused on safety. So do you think there could be any weaknesses in the manufacture of 516, and any weaknesses you think might be there that can maybe be addressed without affecting the... So it's a great question and your points well taken.

Thank you very much for taking my.

Questions.

Apologies, if maybe you addressed it but maybe starting off kind of $5 six and hold that now that <unk>.

It's proved several years boylan notwithstanding the fact, you've had several indeed approved since it seems like FDA getting more focused on safety.

So if you think there could be any weaknesses in the manufacturer.

Hi, Glenn.

Any weakness or do you think might be that it could maybe address that affecting the timeline.

Scott Walsh: Yes, we did make the FT-516. The FT-516 IND was cleared, gosh, I think back in 2019, if I'm remembering correctly. Look, I think certainly while it is an early generation product, I think, as you probably will appreciate... Our manufacturing process, is agnostic, to the Master Salon. So the methods we're using, for instance, to create FT-597, or FT57, are really the same exact methods that we use to create FT5.

Sure. So it's a great question and in your Point's well taken yes, we did make the ft. Five six to the Ft 516, I N. D was cleared gosh I think back in 2019, if I'm remembering correctly.

<unk>.

Look I think certainly while it is an early generation product candidate.

Yeah, I think as you probably will appreciate.

Our manufacturing process.

Is agnostic.

Two the master cell line.

So the the methods we're using for instance to create ft, 596, or F. T five seven and so on.

Really the same exact methods that we use to create ft 516.

Scott Walsh: So the manufacturing processes that we use today in taking a master cell bank, and creating large quantities of NK cells, really transcends the product. And that's, you know, back to Yigal's question. This is why I think, you know, certainly while we're having a discussion around FT516 with respect to RMAT, I think many of the questions that we are intending to ask speak to the platform. Thanks Scott. And then on 516, I'm looking at the press release.

So the manufacturing processes that we use today in taking a master cell bank.

And creating large quantities of NK cells.

Really transcends the product tended and that's you know back to your Gal's question. This is why I think you know certainly while we're having a discussion around ft 516 with respect to our mat.

I think many of the questions that we are intending to ask speak to the platform.

Scott Walsh: I'm trying to pass the terms progressed or elapsed following prior, Prickarty, They almost seem synonyms to me, but I'm sure you've poured over this person. What is the difference between some of those progressive or lapsed followings?

Thanks Kelvin.

One six I'm looking at the press release I'm trying to parse the terms progressed to relax Halloween program.

FDA approved car T.

Senior citizens to me, but I'm sure you get pulled over this press release.

What is the difference between somebody has progressed well matched by quality.

Scott Walsh: I don't have a press release in front of me. I can go back and look at it, but the idea in patients, these are in patients that have been previously treated that have progressed and they may not have had a response or have relapsed following a response. That's the patient population we're targeting down the line of CAR-T, but not Alicia. So does that include patients then who are primary refractory? It could include patients that are primary refractory, that is correct. Okay, okay, perfect. That's what I wanted.

I can't I don't have the press release in front of me I can go back and look at it but the idea in patients. These are patients that have been previously treated that have progressed and they may not have had a response.

Or have relapsed following a response that's the that's the patient population, where we're targeting down line of car T.

No.

Sure.

So does that include patients then climber and everything.

<unk>.

It could include patients that are primary refractory that is correct.

Scott Walsh: And then just in terms of the RCHOP combo, these patients are going to be treated in the community. That's where they're being treated today. So is this a study that you can do in a sort of true community setting as opposed to a kind of outpatient setting of NGH for example? Yes, I think we're pretty confident in that. I mean, I'll turn it over to Wayne, and he can talk about this a little bit more because he's done a lot of work here working with the investigators and the KOLs that helped us develop the protocol.

Okay. Okay, perfect and then just in terms of the onshore combine these patients who are going to be treated in the community.

That's the way to being treated today, but is this the study that you can do in a true community setting as opposed to kind.

Outpatient setting of MGH for example.

Yes, I think we're pretty confident in that I mean, I will turn it over to Wayne and he could talk about this a little bit more because he's done a lot of work here working with the investigators and kols that helped us.

<unk> developed a protocol.

Scott Walsh: Sure. So yeah, we've spoken quite a lot to investigators, https://www.youtube.com.uk and then administration of FT5, https://www.yigalnochomovitz.com that from a safety perspective. FD596 at the doses we've treated to date, quite safe in the sense that, you know, very little in the way of cytokine release syndrome. No, I can't.

Sure. So yeah, we've spoken quite a lot to investigators and key opinion leaders around the concept of a switch.

At its most basic form is essentially standard dose and schedule of R. Chop.

And then administration of Ft, five six a certain period of time after each cycle R. Chop and you know and we've demonstrated with our phase one data of ft, five 6% from a safety perspective.

Ft 596 at the doses, we treated to date is quite safe in the sense that you know very little in the way of.

Cytokine release syndrome, no I can't no gvhd and so when we developed a protocol.

Wayne Chu: And so when we developed the protocol, in partnership with investigators. They were quite comfortable with the idea that, one, from a safety perspective, there doesn't seem to be anything that would be disqualifying in terms of starting the study, and then secondly, there was a quite a degree of comfort that not only would they be able to get patients to be treated with this, but also, Patients in a way that's, you know, reasonably convenient, i.e., you know, giving, administering FU596 in an outpatient setting.

You know what's been partnership with investigators.

We're quite comfortable with the idea that one from a safety perspective, there doesn't seem to be anything that would be disqualifying in terms of starting this study and then secondly, there was a quite a degree of comfort that not only would they be able to get patients to be treated with this but also treat these patients in a way that's.

Reasonably convenient E, giving administering ft 509, six in an outpatient setting. So we're very confident that we will be able to have quite robust enrollment into this trial.

Wayne Chu: So we're very confident that we will be able to have quite robust. If I can just follow up on that, I mean, I can envision a situation where the patient gets the art shop in the community oncology office, but it sounds like then you might be sending the patient.., to the local car to the tree. No, that's that's not what's contemplated here. Okay, okay, that's not what's complicated. That's not what's complicated.

Sorry, if I can just follow up on that I mean, I can envisage a situation where the patient gets the I'll jump in the community oncology all of it. It sounds like then you might be sending their patients to the local car T treatment.

No.

That's not what's contemplated here.

Okay. Good.

Yeah, No no that's not what that's not what's complicated this is community setting outpatient treatment.

Scott Walsh: This is community setting outpatient treatment. Well, thank you. Thank you very much. Our next question is from Michael Schmidt with Guggenheim. Michael, your line is now open.

Perfect. Thank you very much.

Sure.

Our next question is from Michael Schmidt with Guggenheim Michael Your line is now open.

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

Operator: Um, for five, nine, Up to how many dose cycles can be administered? And can you just remind us what patients are eligible to receive additional cycles now that the protocol amendment, I think, is in place? And then just a quick follow-up on that.

For 96 plus Rituximab.

How many of those cycles can be administered in can you just remind us what patients are eligible to receive additional cycles now.

Protocol Amendment I think is in place and then just a quick follow up on that I guess, there was some competitor car NK cell data last week and I think for them at least.

Scott Walsh: I guess there was some competitor CAR and K cell data last week, and I think for them, at least, The data suggested that three doses per cycle was better than two doses. I guess, is this something.., that you guys would consider looking at in your treatment schedules, or are you pretty set on two doses per cycle for 596 at this time? Thank you.

The data suggested that three doses per cycle was better than two doses I guess is there something.

That you guys would consider looking at your treatment schedules are you pretty set on two doses per cycle fir for 596 at this time. Thank you.

Scott Walsh: Sure, I guess I'll address the last question first. Yeah, I mean, we are giving two doses of FT-596 on day one and day 15. In addition, 576 being delivered on day one and 15.

Sure I guess I'll address the last question first yes, I mean, we are giving two doses of <unk> 596 on day, one and day 15. An addition, 507 six being delivered on day one in 15.

The reality is we've seen responses from single doses right. So I think and we've looked at a lot of translational data and feel very comfortable with the functional persistence profile extending.

For about two weeks, so we feel pretty comfortable with the two dose schedule given that what we've seen on the translational side and given the fact that we've seen responses at that.

Scott Walsh: The reality is we've seen responses from single doses, right? So I think and we've looked at a lot of translational data and feel very comfortable with the functional persistence profile extending for about two weeks. So we feel pretty comfortable with the two-dose schedule given that what we've seen on the translational side and given the fact that we've seen responses with a single dose. That said, our protocols have a tremendous amount of flexibility in them.

With a single dose.

That said our protocols have a tremendous amount of flexibility in them and we certainly have the opportunity to backfill patients into a three dose cohort.

Scott Walsh: And we certainly have the opportunity to backfill patients into a three-dose cohort if we chose to do that. So we have a lot of flexibility under the existing protocols. I would say similarly with respect to cycles, the protocols are set up essentially as a first cycle, a second cycle, and then I think under the existing protocols, and Wayne, you can correct me if I'm wrong, I believe under the existing protocols, patients do have the ability to go on to additional sites. I know, Wayne, you want to comment on that, Michael?

If we chose to do that so we have a lot of flexibility under the existing protocols I would say similarly with respect to cycles.

The protocols are set up.

Essentially adds.

Our first cycle.

A second cycle and then I think under the existing protocols and Wayne you can correct me if I'm wrong I believe under the existing protocols patients do have the ability to go into additional cycles.

And when you want to comment on that cycle.

Wayne Chu: Yeah, yeah, that's, that's, that's, now because FDA, Allowunga, Directly to a Second Cycle, we consider an initial treatment course with FT519, https://www.yigalnochomovitz.com we have the option for re-treatment of. Got it. Okay. Thank you so much. Our next question is from Mara Goldstein, we hope. Mara, your line is now.

Yes.

Absolutely correct right now because of that.

FDA, allowing us to proceed directly to a second cycle.

We consider it an initial treatment course with ft, 596%, consisting up to true cycle.

And then in addition to that specifically.

Specifically in patients who have an initial responses and subsequently progressed.

Have the option for re treatment of those patients as well.

Got it okay. Thank you so much.

Sure.

Our next question is from Mara Goldstein with Mizuho.

Your line is now.

Mara Goldstein: Great. Thanks so much for taking the questions. Scott, I want to be respectful, obviously, of trade secrets and the like, but maybe you can talk a little bit about the CMC and, you know, what would be considered from your viewpoint a positive outcome from FDA with respect to the upcoming meeting. And really, maybe if you could just give us something to think about in terms of what are the types of questions that you might be asking.

Great. Thanks, so much for taking my questions.

Scott I wanted to be respectful Avi.

Trade secrets, and the like but maybe you can talk a little bit about the.

The CMC and you know what would be considered from your viewpoint a positive outcome from from FDA with respect to the upcoming meeting and we may be if you could just give us something to think about in terms of what are the types of questions that you might be asking and then I just had a question on the phase <unk> trial.

Mara Goldstein: And then I just had a question on the 516 trial, and I'm curious if the protocol allows for the individual assessment of relapsed patients versus refractory patients. So, can you just clarify the second question first? What do you mean specifically?

If that protocol last Friday, individuals' statin Smith of relapsed patients versus refractory patients.

Uh huh.

Can you just clarify the second question first what do you mean, specifically do we try to call them.

Scott Walsh: Do we treat refractory patients, refractory to last therapy as opposed to relapse to last therapy? Is that the question? Last therapy? Right. And if you are able to look at the outcomes, you know, within those buckets of, you know, within those different subgroups or it's just a global subgroup relapse refractory. Currently, the cohorts are relapse, refractory in the same cohort, but that doesn't mean we can't segregate that on a go-forward basis, if we chose to do so, and treated them as unique populations. We would certainly be able to do that on a go-forward basis. But currently, the cohorts are relapsed for last therapy, as well as refractory to last therapy. CMC, gosh.

Do we treat refractory patients with relapsed or refractory to last therapy as opposed to relapse to last therapies at the question last therapy.

And if you are able to look at the outcomes you know within those buckets or.

Most different subgroups or it's just that global separately relapsed refractory.

Our current currently the cohorts are relapsed refractory and the same cohort, but that doesn't mean.

We can't segregate that on a go forward basis, if we chose to do so and treated them as unique populations. We would certainly be able to do that on a go forward basis, but currently the cohorts of relapsed relapsed or last therapy as well as refractory to last therapy. Okay.

Scott Walsh: I guess, and thank you for making a comment about respectful trade secrets. I think, you know, one of the elements that has hung up cell therapy companies in the past, as I think you're well aware, is oftentimes potency assays. So you may suspect that one of the things that we certainly want to get ahead of in conversation with the FDA are, for instance, some of the potency assays that we've developed. And now you could say, for instance, whether it be CAR-19 or CAR-BCMA, gosh, you know, there may not be a lot of trade secrets or a lot of innovation with respect to those potency assays. But CD16 is a powerful mechanism here.

CMC Gosh I got I guess.

And thank you for making the comment about respectful of trade secrets.

I think one of the elements that has hung up cell therapy companies in the past.

I think you're well aware.

Is there are oftentimes potency assays.

So you you may suspect that one of the things that we certainly want to get ahead of in conversation with the FDA.

For instance, some of the potency assays that we've developed and now you could say for instance, whether it be car 19 or car be CMA gosh, you know there may not be a lot of trade secrets or a lot of innovation with respect to those potency assays, but CD 16 has a powerful mechanism here and so we are suspecting don't know, but suspecting that we will require.

Scott Walsh: And so we are suspecting, don't know, but suspecting that we will require a potency assay for CD16. And so that's certainly something as an example that we would want to discuss with the FDA, given the prevalence of CD16, that feature, the high-affinity, non-cleavable CD16 receptor that we're using throughout our product. Again, sort of hearkening back to the comments that I made that, you know, many of the questions we're going to ask here are not just relevant for 516, but are relevant for 596 as well as our participants.

You're a potency assay for <unk> 16, and so that's certainly something as an example that we would want to discuss with the FDA given the prevalence of <unk> 16.

That features a high affinity non cleavable CD 16 receptor that were using throughout our product candidates again sort of harkening back to the comments that I made that many of the questions. We're gonna ask here are not just relevant for 516, but are relevant for 596 as well as our platform.

Scott Walsh: I think the other thing that we want to have a conversation with FDA about is obviously, you know, not necessarily potency assay, but there are a whole host of other release specifications that are relevant for cell therapies. And beginning to reach agreement on release specifications for the conduct of a pivotal study, I think, again, can apply universally to our program. Okay, and if I could just ask a question, I mean, clearly you have a lot of resources, you'll end this year with $400 million, I understand, not including any types of milestones or whatnot, but, you know, given the pipeline that you have and the plans to go into additional, you know, bigger and potentially more complex studies, I mean, how do you think about financing post, you know, 2022? Look, I think we have two terrific collaborations with Ono and J&J that can provide meaningful streams. Do I think they're going to offset the entire burn of the company? No, I don't.

The other thing that we want to have a conversation with the FDA about is obviously you know not necessarily potency assay, but there are a whole host of other release specifications that are relevant for cell therapies and <unk>.

Beginning to.

Reach agreement on release specifications for the conduct of a pivotal study I think again.

Can apply universally to our product candidates.

And if I could just ask a question I mean, clearly you have a lot of resources.

One last year with 400 million.

I understand not including any types of milestones or whatnot.

Kevin.

Given the pipeline that you have and the plans to go into additional bigger and potentially more complex studies I mean, how do you think about financing post.

2022.

Look I think we have two terrific collaboration with Ono and J&J that can provide meaningful streams do I think they're going to.

Offset the entire burn of the company no I don't but I do think the Ono and Janssen collaborations we have strong momentum. We're seeing success. It's publicly out there maybe not exactly with respect to timelines and milestones at each stage, but it's publicly out there what the milestones can reserve can represent with respect to each and every product.

Scott Walsh: But I do think the Ono and Janssen collaborations, we have strong momentum, we're seeing success. It's publicly out there, maybe not exactly with respect to timelines and milestones at each stage, but it's publicly out there. What the milestones can represent with respect to each and every product candidate. And currently, I alluded to the fact that we think we have three product candidates emerging from the two collaborations. And I do think there's the room for the company to do more collaborations. And I think, you know, we are actively in discussions to engage in more collaborations. All right, thanks, I appreciate it.

Candidate and currently I alluded to the fact that we think we have three product candidates emerging from the two collaborations and.

And I do think there is the room for the company to do more collaborations and I think you know we are.

We're actively in discussions to engage in more collaborations.

Alright, Thanks I appreciate it.

Sure.

Our next question is from Robert Robin <unk> from <unk> Securities.

Operator: Sure. Robin Karkinakis from Truistic Health. Hi, guys.

Robin Karkinakis: Thanks for taking my question. And I could spend the whole day on your new technology. But let me just ask a few.

Hi, guys. Thanks for taking my question and I could spend the whole day on your new technology.

Scott Walsh: So, on the dose, there's another question on the competitor data. That data used very high doses of 1 to 1.5 billion cells multiple times in AML and TLB-CL. I was just curious your thoughts on the read here to your whole program in dosing that high. Like, does the cell type matter, like IPC versus, you know, just either donor-derived or another form of an NK cell? Or does this tell you that high doses really might work the best and you may have to get up to that 1 to 1.5 billion dose? The second question is, how high per dose will you go? And then I'd follow up on the R-MATCH trial.

But let me just ask a few on the Jos.

And there was another question on the competitor data that data use it very high doses of one to $1 5 billion cells multiple times in AML until D. C. L. I was just curious your thoughts on the read here to fight to your whole program in dosing that high just to sell tightened matter like ITC versus you know just a either a donor.

Arrived or another form of an NK cell or does this tell you that high doses really might work the best and he may have to get up to that one to one 5 billion.

Hello.

The second question is how high or dose will you go and then I had a follow up on the <unk> trial.

Scott Walsh: So I guess a couple things and I will say with respect to dose, again, there's, a lot of literature and obviously clinical experience with NK cells versus T cells. And let's just stick in the lymphoma space because it's the easiest to compare and contrast. In the lymphoma space, right, obviously with CAR T cells, in the approved CAR T cells, we've seen doses that are fairly modest compared to an NK cell. I mean, we've seen doses in the 100 to 200 million range. Single dose, 100 to 200 million cells with Yescarta is the recommended dose, is the dose that's used today.

So I guess, a couple of things and I will say with respect to dose.

Again, there's.

A lot of a lot of literature, and obviously clinical experience with NK cells versus T cells, and let's just stick in the lymphoma space because its the easiest to compare and contrast.

In the lymphoma space right, obviously with car T cells in the approved car T cells, we've seen doses.

Fairly modest compared to an NK cell I mean, we've seen doses in the $100 million to $200 million range.

Single dose 100 to 200 million cells with yes. Carla is the recommended dose is the dose that's used today I mean, that's exceptionally low compared to NK cell and the history of donor derived NK cell. If you look at the history of donor derived NK cell therapy, and you go back and you look at the history.

Scott Walsh: I mean, that's exceptionally low compared to NK cell and the history of donor-derived NK cell. If you look at the history of donor-derived NK cell therapy and you go back and you look at the history, my gosh, people are giving, you know, not 900 million cells. They're giving like 5, 6, 7, 8 billion cells. So, you know, back to Daina's question, I mean, the history of donor-derived NK cell therapy, in order to try and drive even modest efficacy, folks have been delivering a multiple of the NK cell compartment that actually just exists within your body, which obviously now, and we've always said, and others in the industry will say the same thing, gosh, you know, if you really wanna make an NK cell efficacious, you're gonna have to engineer in functional elements.

My Gosh people are giving you know not 900 million cells, they're giving like 567 8 billion cells. So you know back to Dana's question I mean.

The history of donor derived NK cell therapy in <unk> in order to try and drive even modest efficacy.

Folks have been delivering a multiple of the NK cell compartment that actually just exists within your body, which.

Obviously now when we've always said and others in the industry will say the same thing gosh. If you really want to make an NK cell efficacious youre going to have to engineer in functional elements and I think with those engineering and functional elements, whether it be a car or a CD 16 receptor or what have you I do think youll see dose levels of NK.

Scott Walsh: And I think with those engineering in functional elements, whether it be a CAR or a CD16 receptor or what have you, I do think you'll see dose levels of NK cells, lower dose levels of NK cells be more efficacious, but clearly they are going to be at dose levels I think that are higher than T cells. And I think that gets back to a little bit of the nature of a T versus an NK.

<unk> sells lower dose levels of NK cells being more efficacious, but clearly they are going to be a dose level, but I think that are higher than T cells, and I think that gets back to a little bit of the nature of a T versus an NK when a T cell gets activated it is quite capable of undergoing significant expansion and proliferation and they do persist.

Scott Walsh: When a T cell gets activated, it is quite capable of undergoing significant expansion and proliferation, and they do persist longer compared to an NK cell, which is not going to significantly expand as a T cell would.

Longer compared to an NK cell, which is not going to significantly expand as a T cell wood and it's nowhere it is not going to functionally persist as long as a T cell. So I think we've always believed and I think it's playing out that the NK cell dosing doses and schedules will be different than what you have.

Scott Walsh: And it's nowhere, it is not going to functionally persist as long as a T cell. So I think we've always believed, and I think it's playing out, that the NK cell doses and schedules will be different than what you have typically seen with T cells. The good news I would say with respect to the NK cell community, while it may require higher doses, while it may require multiple doses, safety profile I still think is significantly differentiated compared to a T cell. And since you don't know how durable those funds are yet, would you just hire?

Typically seen with T cells the.

The good news I would say from with respect to the NK cell community. While it may require high doses, while it may require multiple doses safety profile I still think is significantly differentiated compared to a T cell.

And since you don't know how terrible chances are yet would you dose higher.

Scott Walsh: I think that's the feedback that we got at ASH at some basic level from our investigators. We don't know what the durability is of an NK cell versus a T cell. No one knows. I mean, really, that question has not been answered in the community yet.

And then where you are yeah, absolutely I mean.

Yeah, I mean, I think that's the feedback that we got it at ash at some basic level from our investigators we don't know what the durability is of an NK cell versus a T cell no. One knows I mean really that that question has not been answered in the community yet what's the durability of an NK cell and so given the safety profile, yes, we absolutely and we're at $1 eight.

Scott Walsh: What's the durability of an NK cell? And so given the safety profile, yes, we absolutely, and we're at 1.8 billion cells. So we will continue to dose escalate. We think we certainly have a platform that allows for the delivery of high doses, if that's necessary, and multiple doses. And then a follow-up question on the RMAT 516 meeting. Do you have a sense of, for your clinical trial, how far out you might have to follow patients?

Billion cells. So we will continue to.

Dose escalate, we think we certainly have a platform that allows for the delivery of high doses, if that's necessary and multiple doses.

And then a follow up question on the arm at 560, <unk> do you have a sense of.

For your clinical trial, how far out you might have to follow patients theres been a lot of discussion.

Scott Walsh: There's been a lot of discussion, versus the early CAR T studies that you kind of knew like within six months that there was durability or deep response, give any sense of that. And then I'm sorry, squeeze this one in for your ADR. How close to market are you?

Since the early car T studies that you kind of knew like within six months durability or deep response.

Any sense of that and then I'm sorry squeeze one in for your ADR, how close to market are you in there no more questions. Thanks.

Scott Walsh: And then no more questions. Okay, um... So we're gonna discuss the clinical trial design, obviously with the FDA and discuss potential endpoints. I think, you know, again, I think the one thing I would point out is, at least in the post-CAR T-cell patient population, you know, I had some remarks with respect to the benchmarks that are out there with respect to, you know, therapies that are being at least trying to be deployed by physicians today.

Okay.

So I'm going to discuss the clinical the clinical.

Clinical trial design, obviously with the FDA and discuss potential endpoints I think you know again I.

I think the one thing I would point out is at least in the post car T cell patient population.

You know I mean, I had some remarks with respect to the benchmarks that are out there with respect to you know.

Therapies that are being at least trying to be deployed by physicians today.

Scott Walsh: And I think, you know, we made a remark that the, you know, complete response rates are somewhere between five to 25% and overall survival, overall survival, you know, is around six months. So, I think you're potentially looking at a very difficult-to-treat patient populations where outcomes for better or for worse are determined very quickly. With respect to ADR, We, we, we, we have a lot of preclinical data with ADRs. We have not necessarily decided yet what product candidate to incorporate ADR technology into.

And I think you know we made a remark that the complete response rates are somewhere between 5% to 25% and overall survival overall survival.

Is around six months.

So I think you are potentially looking at a very very difficult to treat patient populations, where outcomes for better for worse are determined very quickly.

With respect to ADR.

We.

We have a lot of preclinical data with a D. R's, we have not necessarily decided yet what product candidate to incorporate ADR technology into that said, we think ADR technology and the idea of chemotherapy free cash.

Scott Walsh: That said, we think ADR technology and the idea of chemotherapy-free conditioning and delivery of cell therapy is the direction the field must go. We absolutely believe that PSY flu, long-term, is a barrier to cell therapy's ultimate potential, and technologies will need to be developed and utilized to reduce the dependency and requirement on PsyFlu.

Conditioning and delivery of cell therapy is the direction the field must go.

We absolutely believe that Si flu long term is the barrier to cell therapies ultimate potential.

And technologies will need to be developed and utilized to reduce the dependency and requirement on site flu and I do think we are targeting.

Scott Walsh: And I do think we are targeting a 2023 time period for the integration of ADR technology. Great, thank you. Sure. And at this time, I would, Conference, back to Scott.

'twenty 'twenty three time period for the integration of the ADR technology.

Great. Thank you.

Sure.

Right.

Operator: Thank you very much. I appreciate everyone's time this afternoon. Thank you all for participating. Be well and look forward to catching up soon. This concludes today's conference call. Thank you for participating. © BF-WATCH TV 2021

And at this time I would now like to turn the conference back to Scott Walsh.

Thank you very much I appreciate everyone's time. This afternoon. Thank you all for participating b, well and look forward to catching up soon.

This concludes today's conference call. Thank you for participating you may now disconnect.

Okay.

Okay.

Sure.

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