Q1 2024 Fate Therapeutics Inc Earnings Call & Business Update

May 9, 2024

Operator: Welcome to the Fate Therapeutics first quarter 2024 financial results conference. At this time, all participants are in listening mode. This call is being webcast live on the Investor Sections of FATE's website at www.fatetherapeutics.com. As a reminder, today's call is also being webcast on the Investor Sections of FATE's website at www.fatetherapeutics.com. Now, I would now like to turn the

Welcome to the fate Therapeutics first quarter 2024 financial results conference call. At this time all participants are in listen only mode. This call is being webcast live on the investors section of fates website at fate Therapeutics dotcom.

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

Operator: I would now like to turn I would now like to introduce Scott Wasco, President and CEO of fate Therapeutics. Please go ahead.

Scott Walshco: Scott Walshco, President and CEO of Fate Therapeutics, please go ahead. Thank you. Good afternoon, and thanks, everyone, for joining us for the Fate Therapeutics first quarter 2024 financial results call. Shortly after 4 p.m.

Speaker Change: Thank you.

Speaker Change: Good afternoon, and thanks, everyone for joining us for the fate Therapeutics first quarter 2024 financial results call. Shortly after four PM eastern time today.

Scott Walshco: ET 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, 2024, was filed shortly thereafter, and can be found on the Investors section of our website under Financial Information. Before we begin, I would like to remind everyone that, except for statements of historical fact, statements made by management and responses to questions on this conference call are forward-looking statements under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements.

Scott Walshco: We issued a press release with these results, which can be found on the investors section of our website under press releases.

Scott Walshco: In addition, our Form 10-Q for the quarter ended March 31, 2024 was filed shortly thereafter and can be found on the investors section of our website under financial information.

Scott Walshco: 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 1095.

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

Scott Walshco: Please see the forward-looking statement disclaimer in the company's earnings press release issued after the close of market today, as well as the risk factors included in our Form 10-Q for the quarter ended March 31, 2024 that was filed with the SEC. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, as facts and circumstances underlying these forward-looking statements may change. Except as required by law, Fate Therapeutics disclaims any obligation to update these forward-looking statements to reflect future information, events, or circumstances.

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

Scott Walshco: As well as the risk factors included in our Form 10-Q for the quarter ended March 31, 2024 that was filed with the SEC today.

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

Scott Walshco: Except as required by law fate therapeutics disclaims any obligation to update these forward looking statements to reflect future information.

Scott Walshco: Where circumstances.

Scott Walshco: Joining me on today's call are Ed Dulac, our Chief Financial Officer, and Dr. Bob Valamehr, our Chief Research and Development Officer. We will focus today's remarks on the data presented today at the American Society of Gene and Cell Therapy annual meeting for our off-the-shelf FT819 CAR T-cell and FT522 CAR NK cell programs and discuss key program initiatives that we are pursuing to achieve therapeutic differentiation and In addition, we will highlight clinical readouts that we are projecting to achieve in 2024 across our IPSC product pipeline for the treatment of cancer and autoimmune disease. Finally, we will review our financial position, where our first quarter capital raise and strong cash balance have created operating runway into the second half of 2026.

Scott Walshco: Joining me on todays call are Ed do Lark, our Chief Financial Officer, and Dr. Bob <unk>, Our Chief Research and development Officer.

Scott Walshco: We will focus today's remarks on the data presented today at the American Society of gene and cell therapy annual meeting.

Scott Walshco: For our off the shelf FTA 19 car T cell and <unk> car NK cell programs.

Scott Walshco: And discuss key program initiatives that we're pursuing to achieve therapeutic differentiation and improve patient outcomes in.

Scott Walshco: In addition, we will highlight clinical readouts that we are projecting to achieve in 2024 across our Ips C product pipeline for the treatment of cancer and autoimmune diseases.

Scott Walshco: Finally, we will review, our financial position, where our first quarter capital raise and strong cash balance have created operating runway into the second half of 2026.

Scott Walshco: Beginning with FT-819, our off-the-shelf CD19-targeted CAR T-cell program. Today, at the ASGCT annual meeting, we presented translational data from our FT-819 Phase 1 study in relapsed refractory B-cell malignancies, which show that a single dose of FTA-19 exhibited multiple mechanisms of action implicated in generating an immune reset in patients with B-cell The translational data supporting these mechanisms included rapid, deep, and sustained CD19-positive B-cell depletion in the peripheral blood; patient case studies of primary, secondary, and tertiary tissue trafficking, infiltration, and activity with CD19 positive B cell elimination in tissue; and patient case studies of plasma cell depletion and B-cell reconstitution, with recovery of naive B-cells and little to no recovery of activated memory B Notably, we also presented patient case studies demonstrating rapid, deep, and sustained B-cell depletion, accompanied by clinical response, without the use of flu therapy as a conditioning agent.

Scott Walshco: Beginning with the FTA 19 are off the shelf CD 19 targeted car T cell program.

Scott Walshco: Today at the <unk> annual meeting, we presented translational data.

Scott Walshco: From our F. T 819 phase one study in relapsed refractory B cell malignancies, which show that a single dose of F. T 19 exhibited multiple mechanisms of action implicated in generating an immune reset in patients.

Scott Walshco: With B cell mediated autoimmune diseases with.

Scott Walshco: Translational data supporting these mechanisms included rapid deep and sustained CD 19 positive b cell depletion in the peripheral blood.

Scott Walshco: Patient case studies of primary secondary and tertiary tissue trafficking infiltration and activity with CD 19 positive diesel elimination in tissue.

Scott Walshco: And patient case studies of plasma cell depletion and B cell reconstitution.

Scott Walshco: With recovery of naive b cells, and little to no recovery of activated memory b cells or plasma blasts.

Scott Walshco: Notably, we also presented patient patient case studies, demonstrating rapid deep and sustained b cell depletion occur.

Scott Walshco: Accompanied by clinical responses without the use of Fludarabine as a conditioning agent.

Scott Walshco: Collectively, we believe these data support the disease-modifying potential of FT-819 for patients with B-cell-mediated autoimmune disease. To that end, I am pleased to announce that the first lupus patient has been treated in our Phase 1 autoimmunity study of FDA-19. This first patient, a 27-year-old woman with refractory disease, despite having previously been treated with multiple standard-of-care therapies, received conditioning chemotherapy, followed by a single dose of FT-819 at 360 million cells. The patient was discharged after a three-day hospitalization stay without any notable adverse events.

Scott Walshco: Collectively we believe these data support the disease modifying potential of FTA 19 for patients with B cell mediated autoimmune diseases.

Scott Walshco: To that end I am pleased to announce that the first lupus patients has been treated in our phase one autoimmune disease study of FTA 19.

Scott Walshco: This first patient with <unk>.

Scott Walshco: 27 year old woman with refractory disease, despite having previously been treated with multiple standard of care therapy.

Scott Walshco: Received conditioning chemotherapy.

Scott Walshco: Followed by a single dose of FTE 819 at 360 million cells.

Scott Walshco: The patient was discharged after a three day hospitalization stay.

Scott Walshco: Without any notable adverse events.

Scott Walshco: At ASGCT today, we also presented promising data from a first-of-kind translational app, using a sample of the patient's blood obtained prior to the administration of conditioning chemotherapy, where we observed rapid and potent depletion of the patient's CD19-positive B cells in an ex vivo cytotoxicity assay with the FT-819. It is worthwhile to note that treatment of this first patient occurred within weeks of site activation. We believe this patient experience exemplifies the potential of an off-the-shelf cell therapy to overcome challenges that may hinder autologous cell therapies in reaching patients with autoimmune diseases, including the need for a theresa, Complex Manufacturing and Treatment Logistics, and Extended Patient Hospitalization.

Scott Walshco: <unk> today, we also presented promising data from a first of calling translational assay.

Scott Walshco: Using a sample of the patients blood obtained prior to administration of conditioning chemotherapy.

Scott Walshco: Where we observed a rapid and potent depletion of the patients CD 19 positive b cells in an ex vivo cytotoxicity assay with the FTA 19.

Scott Walshco: It is worthwhile to note that treatment of this first patient occurred within weeks of site activation.

Scott Walshco: We believe this patient experienced exemplifies the potential of an off the shelf cell therapy to overcome challenges that may hinder autologous cell therapies in reaching patients with autoimmune diseases.

Scott Walshco: <unk> the need for a freezer.

Scott Walshco: Complex manufacturing and treatment logistics and extended patient hospitalization.

Scott Walshco: Furthermore, since we have observed deep B-cell depletion and clinical response without the use of fludarabine as a conditioning agent in our phase one study of FT819 for B-cell malignancy, we believe FT819 may have disease-modifying potential in autoimmunity using alternative conditioning regimens. We plan to amend the current clinical protocol for our Phase I autoimmunity study in the second quarter of 2024 to enable FT-819 administration with single-agent Cytoxan at the same dose used by rheumatologists for treatment of patients with autoimmune disease.

Scott Walshco: Furthermore, since we have observed deep b cell depletion and clinical responses without the use of fludarabine as a conditioning agent in our phase one study of <unk> for B cell malignancies.

Scott Walshco: We believe the FCA 19 may have disease modifying potential in autoimmunity using alternative conditioning regimens.

Scott Walshco: We plan to amend the current clinical protocol for our phase one autoimmunity study in the second quarter of 2024.

Scott Walshco: To enable FTA 19 administration with single agent site toxin.

Scott Walshco: At the same dose used by Rheumatologists for treatment of patients with autoimmune diseases.

Scott Walshco: We believe that an off-the-shelf add-on of FT-819 to commonly used treatment regimens may contribute to a highly differentiating patient experience. Dose escalation in our FT-819 Phase 1 study in relapsed refractory B-cell malignancies has now completed, where 43 patients were treated with a single dose of FT-819 at up to 1 billion cells without HLA max. We observed clinical responses, including complete responses, in heavily pre-treated patients with aggressive disease, including in relapsed refractory large B-cell lymphoma patients that were previously treated with autologous DD19-targeted CAR T-cell therapy.

Scott Walshco: We believe that an off the shelf add on of FTA 19, two commonly used treatment regimens may contribute to a highly differentiating patient experience.

Scott Walshco: Dose escalation and our FTA 19 phase one study in relapsed refractory B cell malignancies has now completed.

Scott Walshco: We're 43 patients were treated with a single dose of FTE 19 at up to 1 billion cells without HLA matching.

Scott Walshco: We observed clinical responses, including complete responses in heavily pre treated patients with aggressive disease <unk>.

Scott Walshco: Including in relapsed refractory large b cell lymphoma patients that were previously treated with autologous <unk> 19 targeted car T cell therapy.

Scott Walshco: The safety and tolerability profile of FT-819 was favorable, with no dose-limiting toxicities, no events of any grade of ICANs, or graft-versus-host disease, and a low incidence of only low-grade CRS. We believe the established clinical safety and tolerability profile of FT-819 is differentiated, and may also be of significant importance for treatment of patients with autoimmune disease. At this time, we intend to focus all further clinical development of FT-819 exclusively on autoimmune diseases. Today, at the ASGCT annual meeting, we also presented data from our FT522 off-the-shelf CD19-targeted CAR and K-cell programs, the first product candidate emerging from our IPSC product platform that incorporates our own immune defense receptor technology.

Scott Walshco: The safety and Tolerability profile of FTA 19 was favorable.

Scott Walshco: With no dose limiting toxicities.

Scott Walshco: No events of any grade of cans or graft versus host disease.

Scott Walshco: And low incidents of only low grade Crs.

Scott Walshco: We believe the established clinical safety and Tolerability profile of FTA 19 is differentiated.

Scott Walshco: And may also be of significant import for treatment of patients with autoimmune diseases.

Scott Walshco: At this time, we intend to focus all further clinical development of FTA 19 exclusively in autoimmunity.

Scott Walshco: Today at the <unk> annual meeting, we also presented data from our ft. Five two to off the shelf CD 19 targeted car NK cell program.

Scott Walshco: Which is the first product candidate emerging from our <unk> product platform that incorporates our own immune defense receptor technology.

Scott Walshco: Today, the Treatment Course for Administration of Cell-Based Immunotherapy, including both autologous and allogeneic cell therapies, requires conditioning patients with chemotherapy. However, conditioning chemotherapy can induce toxicities, prevent combination with standard of care treatments widely used in community-based settings, and limit patient access and reach.

Scott Walshco: Today, the treatment course for administration of cell based Immunotherapies.

Scott Walshco: <unk>, both autologous and allogeneic cell therapies requires conditioning patients with chemotherapy.

Scott Walshco: Conditioning chemotherapy can induce toxicities.

Scott Walshco: In combination with standard of care treatments widely used in the community based settings.

Scott Walshco: And limit patient access and reach.

Scott Walshco: ADR technology incorporated into <unk>, two is designed to enable effective treatment without administration of conditioning chemotherapy to patients.

Scott Walshco: Which we believe has the potential to redefine the cell therapy treatment paradigm.

Scott Walshco: We have previously presented preclinical data using cancer cell lines, demonstrating that the co culture of ADR armed car NK cells with allo reactive T cells.

Scott Walshco: Promotes NK cell proliferation.

Scott Walshco: Enhances NK cell persistence and increases anti-tumor activity, indicating that arming with ADR technology has the potential to enable effector cell function in the presence of an alloreactive system. Today, at the ASGCT annual meeting, we reported preclinical data using SLE-diseased cells in a novel rechallenge assay using peripheral blood mononuclear cells from an unmatched SLE donor. FT522 uniquely drove rapid and deep depletion of CD19-positive donor B cells, eliminated alloreactive donor T cells, and maintained Functional Persistence, with the ability to kill additional CD19-positive donor B cells upon reach-out.

Scott Walshco: Enhances NK cell persistence.

Scott Walshco: And increases anti tumor activity.

Scott Walshco: Indicating that our roaming with ADR technology has the potential to enable effector cell function in the presence of an allo reactive system.

Scott Walshco: In addition, we also presented initial translational data from the first two patients treated in our ongoing phase one study of FT522 in relapsed refractory B-cell lymphoma. These data show enhanced persistence of 5-2-2 in the periphery, compared to clinical data observed with FT-596, a prior-generation CD19-targeted CAR and K-cell without ADR technology.

Scott Walshco: Today at the <unk> annual meeting, we reported preclinical data using <unk> diseased cells.

Scott Walshco: In a novel re challenge assay using peripheral blood mononuclear cells from an unmatched SLE donor.

Scott Walshco: <unk> two uniquely drove rapid and deep depletion of CD 19 positive donor b cells are eliminated allo reactive donor T cells and maintained functional persistence with the ability to kill additional.

Scott Walshco: <unk> CD 19 positive donor b cells upon re challenge.

Scott Walshco: In addition, we also presented initial translational data from the first two patients treated in our ongoing phase one study of FG 522 in relapsed refractory b cell lymphoma.

Scott Walshco: These data show enhanced persistence of $5 two two in the periphery.

Scott Walshco: Paired to clinical data observed with Ft 596, our prior generation CD 19 targeted car NK cell without ADR technology.

Scott Walshco: Importantly, these data also show rapid, deep, and sustained B-cell depletion in the periphery throughout the one-month treatment cycle. We intend to submit an IND application to the FDA in the middle of 2024 to expand our clinical investigation of FD522 for treatment of various B-cell mediated autoimmune diseases, including without the administration of conditioning chemotherapy to patients. I'm also pleased to report that the first three patients in the conditioning arm of our Phase 1 study of FT5224 relapsed refractory B-cell lymphoma have now completed safety assessment without any dose-limiting toxicity, and there were no events of any grade of CRS, ICANNs, or GVHD. Dose escalation is now ongoing at 900 million cells per dose.

Scott Walshco: Importantly, these data also show rapid deep and sustained b cell depletion in the periphery throughout the one month treatment cycle.

Scott Walshco: We intend to submit an IND application to the FDA in the middle of 2024 to expand our clinical investigation of <unk> <unk> two for treatment of various b cell mediated autoimmune diseases, including without administration of conditioning chemotherapy.

Scott Walshco: <unk> to patients.

Scott Walshco: I'm also pleased to report that the first three patients in the conditioning arm of our phase one study of Ft, 500, <unk> for relapsed refractory B cell lymphoma.

Scott Walshco: Now completed safety assessment without any dose limiting toxicities.

Scott Walshco: There were no events of any grade of Crs I cans or gvhd.

Scott Walshco: Dose escalation is now ongoing at 900 million cells per dose.

Scott Walshco: In addition, patient enrollment has now been initiated in the no conditioning arm at 300 million cells per dose, and we are poised to clinically assess the safety and activity of our ADR-armed FT522 CAR and K-Cell program without the administration of conditioning chemotherapy. Turning to our solid tumor initiatives, I'm also pleased to announce that, in collaboration with Ono Pharmaceutical, we recently treated the first patient in our phase one study of FT825.

Scott Walshco: In addition, patient enrollment has now been initiated in the no conditioning arm at 300 million cells per dose.

Scott Walshco: And we are poised to clinically assess the safety and activity of our ADR armed F. <unk> two car NK cell program without administration of conditioning chemotherapy to patients.

Scott Walshco: Turning to our solid tumor initiatives I'm also pleased to announce that under our collaboration with Ono pharmaceutical we have recently treated the first patient in our phase one study of FTA two five.

Scott Walshco: Designed using the company's IPSC product platform, we believe FTA-25 represents an exciting new frontier in the field of cell-based cancer immunotherapy. The multiplex-engineered, IPS-derived CAR T-cell program incorporates a constellation of synthetic anti-tumor mechanisms, that are designed to harness the potential of both innate and adaptive immunity, and to overcome unique challenges in treating solitude. These mechanisms include a CXCR2 receptor to promote cell trafficking, a chimeric TGF-beta receptor to redirect immunosuppressive signals in the tumor microenvironment, a high-affinity non-cleavable CD16A receptor to promote antibody-dependent cellular cytotoxicity, and a novel cancer-specific HER2-targeted antigen binding donor, which has shown differentiated activity from that of trastuzumab in preclinical studies, including against HER2 low-expressing tumors.

Scott Walshco: Designed using the company's Ips C product platform, we believe FTA two five represents an exciting new frontier in the field of cell based cancer immunotherapy.

Scott Walshco: But multiplexed engineered Ips derived car T cell program.

Scott Walshco: Incorporates a constellation of synthetic anti tumor mechanisms that are designed to harness the potential of both innate and adaptive immunity and.

Scott Walshco: And to overcome unique challenges in treating solid tumors.

Scott Walshco: These mechanisms include a CX <unk> two receptor to promote cell trafficking.

Scott Walshco: Chimeric TGF beta receptor to redirect immuno suppressive signals in the tumor microenvironment.

Scott Walshco: A high affinity non cleavable <unk> receptor to promote antibody dependent cellular cytotoxicity cytotoxicity.

Scott Walshco: And a novel cancer specific her two targeted antigen binding domains.

Scott Walshco: Each has shown differentiated activity from that of Trastuzumab in preclinical studies, including against her two low expressing tumor cells.

Scott Walshco: The first patient in the phase one study was diagnosed with HER2 positive gastroesophageal junction adenocarcinoma, had progressed after receiving multiple lines of treatment, including HER2-targeted therapy, and was administered standard conditioning chemotherapy followed by a single dose of FTA-2-5 as monotherapy at 100 million cells. As we consider our strategic direction, we believe there is a strong value proposition for our IPSC product platform and off-the-shelf cell therapies in autoimmunity where patient safety, convenience, and accessibility, as well as cost and scale, may be key differentiating factors.

Scott Walshco: The first patient in the phase one study was diagnosed with her two positive gastroesophageal junction adenocarcinoma had.

Scott Walshco: Had progressed after receiving multiple lines of treatment, including her to targeted therapies.

Scott Walshco: And was administered standard conditioning chemotherapy, followed by a single dose of FCA two five as monotherapy at 100 million cells.

Scott Walshco: As we consider our strategic direction. We believe there is a strong value proposition for our <unk> product platform and off the shelf cell therapies and auto immunity.

Scott Walshco: Patient safety convenience and accessibility as well as cost and scale.

Scott Walshco: Key differentiating factors.

Scott Walshco: We believe our ADR technology can enable effective treatment with cell therapy without requiring the administration of conditioning chemotherapy to patients, which has the potential to redefine the self-therapy treatment paradigm and patient experience for cancer and autoimmune diseases. And we believe our multiplexed engineered IPFC-derived CAR T-cell platform can deliver multiple synthetic mechanisms of antitumor activity, with the potential to overcome unique challenges in treating solid tumors.

Scott Walshco: We believe our ADR technology can enable effective treatment with cell therapy without requiring administration of conditioning chemotherapy to patients.

Scott Walshco: Each has the potential to redefine the cell therapy treatment paradigm and patient experience for cancer and autoimmunity.

Scott Walshco: And we believe our multiplexed engineered Ips derived car T cell platform can deliver multiple synthetic mechanisms of anti tumor activity with.

Scott Walshco: With the potential to overcome unique challenges in treating solid tumors.

Scott Walshco: As we look ahead into the second half of 2024, we are well-positioned to reach and report on five key clinical milestones across our IPFC product pipeline for cancer and autoimmune disease. Number one, we seek to demonstrate the disease-transforming potential of FT-819 in B-cell-mediated autoimmune disease. Specifically, we expect to read out initial Phase I clinical data for the first three to five patients treated with FT-819 for moderate to severe SOH. Number two, we seek to administer FT-819 without fluid therapy and instead with commonly used treatment regimens for autoimmune diseases.

Scott Walshco: As we look ahead into the second half of 2024, we are well positioned to reach and report on five key clinical milestones across our IP FC product pipeline for cancer and autoimmune diseases.

Scott Walshco: Specifically, we intend to amend the current IND for our FT-819 Phase I autoimmunity study to include administration with single-agent cytoxin and expect to read out initial patient clinical data. Number three, we seek to demonstrate the potential of our proprietary ADR technology to enable effective treatment of patients without the administration of conditioning chemotherapy. Specifically, we expect to read out the first five.

Scott Walshco: Number one we seek to demonstrate the disease transforming potential other FTA 19 in b cell mediated autoimmune diseases.

Scott Walshco: Specifically, we expect to readout initial phase one clinical data for the first three to five patients treated with FCA 19 for moderate to severe SLE.

Scott Walshco: Number two we seek to administer FTA 19 without fludarabine.

Scott Walshco: And instead with commonly used treatment regimens for autoimmune diseases.

Scott Walshco: Specifically, we intend to amend the current IND for our FTA 19 phase one autoimmunity study to.

Scott Walshco: To include administration with single agents by toxin.

Scott Walshco: And expect to readout initial patient clinical data.

Scott Walshco: Number three we seek to demonstrate the potential of our proprietary ADR technology to.

Scott Walshco: To enable effective treatment of patients without administration of conditioning chemotherapy.

Scott Walshco: Specifically, we expect to read out the first five no conditioning patients treated with <unk> and our phase one study for B cell lymphoma.

Edward J. Dulac: No conditioning patients, treated with 5-2-2 in our Phase 1 study for B-solum foam. Number four, we seek to broadly investigate 522 without conditioning chemotherapy for treatment of various B-cell-mediated autoimmune diseases. Specifically, we expect to submit an IND application and, subject to IND allowance by the FDA, initiate patient enrollment in a Phase I multi-indication study of 522 for autoimmunity. And finally, we seek to establish an initial clinical proof of concept for our multiplexed-engineered, IPS-derived CAR T-cell platform in treating solid tumors.

Edward J. Dulac: Number four we seek to broadly investigate five two without conditioning chemotherapy for treatment of various b cell mediated autoimmune diseases.

Edward J. Dulac: Specifically, we expect to submit an IND application and subject to the IMD allowance by the FDA.

Edward J. Dulac: Initiate patient enrollment in our phase one multi indication study of 502 for autoimmunity.

Edward J. Dulac: And finally, we seek to establish a new to show clinical proof of concept for our multiplexed engineered Ips derived car T cell platform in treating solid tumors spa.

Edward J. Dulac: Specifically, we expect to read out the first three to five patients treated with FTA-2-5 in our phase one study for advanced solid tumors. I would now like to turn the call over to Ed to review our financial results for the first quarter. Thank you, Scott, and good afternoon. Fate Therapeutics is in a strong financial position to advance our pipeline of IPSC-derived CAR-T and CAR-NK cell programs for autoimmune diseases and cancer. With the addition of net proceeds from the company's $80 million underwritten offering of common stock and $20 million concurrent private placement of pre-funded warrants in March, our cash, cash equivalents, and investments at the end of the first quarter were approximately $391 million.

Edward J. Dulac: Specifically, we expect to read out the first three years to five patients treated with FTA, two five and our phase one study for advanced solid tumors.

Edward J. Dulac: I would now like to turn the call over to Ed to review our financial results for the first quarter.

Edward J. Dulac: In the first quarter, our reported revenue of $1.9 million was consistent with the prior two quarters and reflects research funding associated with the development of a second product candidate against an undisclosed target in solid tumors under our collaboration with Ono Pharmaceutical. As a reminder, after opting into a U.S. and European co-development and co-commercialization arrangement with ONO for FT825 in the fourth quarter of 2022, we account for that program's reimbursable expenses as an offset within our research and development costs.

Ed: Thank you Scott and good afternoon.

Edward J. Dulac: We recognized $800,000 of Contra R&D expense in the quarter. Research and development expenses for the first quarter were $32.1 million, essentially flat versus the fourth quarter of last year. Our expenditures in R&D were driven primarily by salaries and benefits, including share-based compensation, and from clinical trial costs and demand for R&D materials. General and administrative expenses for the first quarter increased sequentially by 16% to $20.9 million. The increase in our G&A expenses was attributable primarily to increases in legal-related fees.

Edward J. Dulac: Fate Therapeutics is in a strong financial position to advance our pipeline of high PSC derived car T and car NK cell programs for autoimmune diseases and cancer.

Edward J. Dulac: With the addition of net proceeds from the Companys $80 million underwritten offering of common stock and $20 million concurrent private placement of pre funded warrants in March our cash cash equivalents and investments at the end of the first quarter were approximately 391 million.

Edward J. Dulac: <unk>.

Edward J. Dulac: In the first quarter, our reported revenue of $1 9 million.

Edward J. Dulac: It was consistent with the prior two quarters and reflects the research funding associated with the development of a second product candidates against an undisclosed target and solid tumors under our collaboration with Ono pharmaceutical.

Edward J. Dulac: As a reminder, after opting into a U S and European co development and co commercialization arrangement with Ono for FTE two five in the fourth quarter of 2022.

Edward J. Dulac: We account for that program's reimbursable expenses as an offset within our research and development costs.

Edward J. Dulac: We recognized $800000 of Contra R&D expense in the quarter.

Edward J. Dulac: Research and development expenses for the first quarter were $32 $1 million.

Edward J. Dulac: Flat versus the fourth quarter of last year.

Edward J. Dulac: Our expenditures in R&D were driven primarily by salaries and benefits including share based compensation.

Edward J. Dulac: From clinical trial costs and demand for R&D materials.

Edward J. Dulac: General and administrative expenses for the first quarter increased sequentially by 16% to $29 million the.

Edward J. Dulac: The increase in our G&A expenses was attributable primarily to increases in legal related fees.

Edward J. Dulac: Total operating expenses for the first quarter increased by 7% relative to the fourth quarter of 2023 to $53 million, which included $11 million in non-cash, share-based compensation expense. Note that in connection with the development of our off-the-shelf, iPSC-derived CAR T-cell product candidate, FT-819, we previously achieved the clinical milestone set forth in our amended license agreement with Memorial Sloan-Kettering Cancer Center Up to two additional milestone payments may be owed to MSK based on the subsequent trading values of a company's common stock, ranging from $100 to $150 per share.

Edward J. Dulac: Total operating expenses for the first quarter increased by 7% relative to the fourth quarter of 2000 $23 million to $53 million.

Edward J. Dulac: Which included $11 million and noncash share based compensation expense.

Edward J. Dulac: Note that in connection with the development of our off the shelf Ips derived car T cell product candidate FTA 19, we previously achieved to clinical milestones set forth in our amended license agreement with Memorial Sloan Kettering Cancer Center, which.

Edward J. Dulac: Which triggered a first milestone payment to <unk> in 2021.

Edward J. Dulac: Up to two additional milestone payments may be owed to <unk> K based on subsequent trading values of the company's common stock ranging from 100 to $150 per share.

Edward J. Dulac: We assess the fair value of these contingent milestone payments, currently valued at $2.7 million, on a quarterly basis. In the first quarter, we recorded a non-cash, $1.4 million non-operating loss associated with the change in fare value. Our net loss for the quarter was $48 million, or $0.47 per share.

Edward J. Dulac: We assessed the fair value of these contingent milestone payments currently valued at $2 7 million on a quarterly basis.

Edward J. Dulac: In the first quarter, we recorded a noncash $1 4 million non operating loss associated with the change in fair value.

Edward J. Dulac: Our net loss for the quarter was $48 million or <unk> 47 per share.

Operator: Finally, as we consider the investments we plan to make this year, we expect our GAP operating expenses, which includes non-cash items such as stock compensation expense and depreciation, for the full year to be between $215 and $230 million, and that we will end the year with more than $270 million in cash. Cash Equivalents and Investments. I would now like to open the call for questions. We will now begin the question and answer session. To ask, you may press the star, then one on your touch screen.

Edward J. Dulac: Finally, as we consider the investments we plan to make this year, we expect our GAAP operating expenses.

Operator: Which include noncash items, such as stock compensation expense and depreciation for the full year to be between 215 and $230 million.

Operator: And that we will end the year with more than $270 million in cash and cash equivalents and investments.

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

Operator: We will now begin the question and answer session to ask a question you May Press Star then one on your Touchtone phone if youre using a speakerphone. Please pick up your handset before pressing the keys.

Operator: If you are using a speakerphone, please pick up your handset before pressing the button. If, at any time, your question has been addressed, or if you would like to withdraw your... Prastar. At this time, we'll pause momentarily to assemble our. [inaudible] Michael Yee with Jeffrey's, please go ahead.

Michael Jonathan Yee: If at any time. Your question has been addressed and you would like to withdraw. Your question. Please press Star then two at this time, we will pause momentarily to assemble our roster.

Michael Jonathan Yee: The first question comes from Michael <unk> with Jefferies. Please go ahead.

Michael Jonathan Yee: Thank you. We had a two-part question. Congrats on all the progress, Scott. On the autoimmune study that is enrolling, I know that was a bit slow to get off, but it sounds like you're going to have some good momentum and patient patience. Can you just talk a little bit about how the plan to also allow single-agent cytoxin would impact things and how you think about what that would show and how that would impact the design of the study? And then the second question is related to 522.

Michael Jonathan Yee: Thank you we added two part question congrats on all the progress Scott Paul on the autoimmune study that is enrolling I know that was a bit slow to get off but it sounds like youre going to have some good momentum and reported patient can you just talk a little bit about how the plan to also allow us single agents I toxin.

Michael Jonathan Yee: What impact teams and how you think about what that would show and how that would impact the design of the study and then the second question is related to <unk> I think it's exciting youre now in the second cohort without them for depletion can you just talk about the results that you might see there and how you would read through into what you see there into the idea for auto.

Scott Walshco: I think it's exciting you're now in the second cohort without lymphodepletion. Can you just talk about the results that you might see there and how you would read through what you see there into the idea for autoimmune as well? Thank you.

Scott Walshco: Immune as well thank you.

Scott Walshco: So in the autoimmunity study with FDA 19, the current study as designed has two different alternatives for conditioning. There is a standard three-day conditioning cycle of Psi-Flu, which is commonly used in the oncology setting. So I believe it's 500 milligrams per meter squared times three days for cyclothalcimide and 30 milligrams per meter squared times three days for fluid arabine.

Scott Walshco: Sure so with autoimmune in the autoimmune any study with FCA to 19.

Scott Walshco: The current study as designed.

Scott Walshco: <unk> has two different alternatives for conditioning.

Scott Walshco: There is a standard three day conditioning cycle of Si flu, which is commonly used in the oncology setting. So I believe it's 500 milligrams per meter squared times three days for cyclophosphamide and 30 milligrams per meter square.

Scott Walshco: Times three days.

Scott Walshco: Fludarabine.

Scott Walshco: We also have a second in the current study. We also have a second conditioning regimen that is permitted the second conditioning regimen is of Bendamustine based conditioning regimen.

Scott Walshco: And that is at Schuh day treatment regimen, what's been the Boston.

Scott Walshco: Well, we're contemplating doing, and this is based on data we presented today. We believe we have good proof of concept in our FT-819 oncology study. So this is the study in cell malignancies, where several of our patients in that study received bend the muscle as a conditioning agent. So they did not receive CyFlu.

Scott Walshco: While contemplating doing and this is based on data we presented today.

Scott Walshco: We believe we have good proof of concept.

Scott Walshco: In our FCA 19 oncology study.

Scott Walshco: So these witnesses this study in B cell malignancies, where.

Scott Walshco: Where several of our patients in that study received bendamustine as a conditioning agents that they did not receive <unk>. They received have been debased conditioning regimen.

Scott Walshco: They received a Benda-based conditioning regimen in the oncology study. We presented the data on those patients specifically today. We saw very deep B-cell depletion in the periphery, which was maintained through the 30-day treatment cycle. And importantly, we saw clinical response to the Benda and Mustine Treatment, conditioning cycle or conditioning regimen. So we did not use Flutabar, so in that regimen, we're not using Flutarabine

Scott Walshco: The oncology study.

Scott Walshco: We presented the data on those patients specifically today we.

Scott Walshco: Saul very deep B cell depletion in the periphery, which was maintained through the 30 day treatment cycle and importantly, we saw clinical responses.

Scott Walshco: With the Bendamustine treatment.

Scott Walshco: Conditioning cycle or conditioning regimen. So we did not use <unk>. So in that regimen, we're not using fludarabine.

Scott Walshco: So we saw activity with FTA-19 without flu therapy, and that gives us confidence that we can amend the IND to add on to a Cytoxan-only regimen. We believe we can accomplish that efficiently through an amendment to the IND, essentially adding a third, quote-unquote, conditioning regimen for patients. Thus, the study would provide physicians with their choice of Psi-flu conditioning. Vendamustine Conditioning, or Single-Agent Cytoxan Conditioning. And again, since Cytoxan and bust bendamustine are in the same class of molecule and given the activity we've seen in the oncology study, we feel confident in FT-819's ability to perform in a Cytoxan-only regimen without Sluderic. Long answer, but I hope that was clear. Yeah, very nice.

Scott Walshco: So we saw activity with FTA 19 without Fludarabine.

Scott Walshco: And so that gives us confidence that we can amend the IMD.

Scott Walshco: To add on to a site toxin only regimen. We believe we can accomplish that efficiently through a amendment to the IMD.

Scott Walshco: Essentially adding a third quote unquote conditioning regimen.

Scott Walshco: For patients.

Scott Walshco: And so the study will provide physicians choice of Psi fluid conditioning then.

Scott Walshco: The muscatine conditioning or single agents like toxin conditioning and.

Scott Walshco: And again since cytotoxin and bust Bendamustine are in the same class of molecule and given the activity. We've seen in the oncology study, we feel confident in FTE 19 ability to perform in a site toxin only regimen without severity.

Scott Walshco: Long answer, but I hope that was clear.

Scott Walshco: And then the read-through from Oncology, because you're in Cohort D without... Yeah, so with respect to 522... So with 522, obviously, we have a long history with NK cells. We have started the study with CyFlu conditioning, which provides us the opportunity to do some direct comparisons with 522 based on historical data sets that we have generated with FT-596, our prior generation product.

Speaker Change: Very nice and then the read through from oncology because you are in the cohort D without.

Scott Walshco: Conditioning.

Scott Walshco: Yeah, so with respect to $5 two two.

Scott Walshco: So we're thoughtful with $5. Two obviously, we have a long history with NK cells. We have started this study with psi fluid conditioning.

Scott Walshco: It provides us the opportunity to do some direct comparison with $5. Two two based on historical datasets that we have generated with ft 596, our prior generation product with.

Scott Walshco: We presented data today where we believe in early, small numbers of patients, obviously. We think we're seeing some differentiated activity with respect to persistence, which we're excited about. And so, we are very excited now to... essentially begin our clinical experiment with 5-2-2 or clinical experience with 5-2-2 with no conditioning.

Scott Walshco: We presented data today, where we believe in early small numbers of patients. Obviously, we think we're seeing some differentiated activity with respect to persistence, which we're excited about.

Scott Walshco: And so we are very excited now too.

Scott Walshco: Essentially the DNR clinical experiment.

Scott Walshco: With $5 two to her clinical experience with $5 two with no conditioning.

Scott Walshco: Preclinically, and I'll let Bob talk about it, we've done a tremendous amount of work with 522 preclinically in our genetic system, both using cancer cell lines as well as now using donor SLE cells. And we presented the donor SLE preclinical data today. I'll let Bob talk about that because I think it does demonstrate the potential of 522 to essentially thrive in an allogeneic disease. Thanks, Scott.

Scott Walshco: Pre clinically and I'll, let Bob talk about it we've done a tremendous amount of work with $5 two two pre clinically in our generic systems.

Scott Walshco: Both using cancer cell lines as well as now using donor cell Lee sells and we presented the donor cell lead preclinical data today I'll, let Bob talk about that because I think it does demonstrate the potential of $5 two to.

Speaker Change: <unk> thrive in an allogeneic disease system.

Bahram Valamehr: So just to talk about pre-clinical and also answer some of your questions about how the clinical data will play out for autoimmune. So in pre-clinical, as Scott mentioned, having the ADR technology in 5-2-2 allows us to actually show activity and persistence even when there is an intact PBMC compartment. So in a petri dish, we try to mimic what's happening in the patient setting by having the PBMCs, and there are all different types of cells from PBMCs, and we showed that with 5-2-2, you can actually show functional persistence, and this is very unique to the ADR technology because if you have NK cells without ADR or autologous CAR-T, you won't get this observation.

Bob: Thanks, Scott So just to talk about preclinical and also answer some of your questions about how the.

Bahram Valamehr: The clinical data will play out for autoimmune.

Bahram Valamehr: So in the pre clinically as Scott mentioned, having to ACR technology, and <unk> allows us to actually show activity and persistence.

Bahram Valamehr: When there is a PVA and tech pvm's compartment. So in a petri dish, we try to mimic what's happening in that patient setting by having the <unk> and theyre all different types of cells from P&C and we showed that with <unk> you can actually show functional persistence and and this is very unique to the <unk>.

Bahram Valamehr: Technology, because if you have.

Bahram Valamehr: NK cells without ADR or autologous car T. You won't give this observation in this observation is very specific because we can co culture at <unk> with <unk>.

Bahram Valamehr: And this observation is very specific because we can co-culture 522 with PBMC and show that we can target, because there's a CAR-19 in 522, the B cells in PBMC. However, we don't see an allo reaction that's induced by the T cell compartment. Even though these cells have an intact HLA expression on their surface, our product, we are able to hold off the allo reaction because we target the 4-MDB positive population, which is the final stage of an activated cell. So we are able to hold off on that.

Bahram Valamehr: And show that we can target because the car $19 52 to <unk>. However, we don't see in our reaction that's induced by the T cell compartment, even though the cells have an intact HLA expression on the surface. Our product we are able to hold off to allo reaction because we target.

Bahram Valamehr: What form the positive.

Bahram Valamehr: Population, which is the final stage of an activated so so we are able to hold off on that and we can maintain activity through functional persistence because when we re challenge.

Bahram Valamehr: And we can maintain activity through functional persistence because when we re-challenge the 522 co-culture with additional PBMC, we can continue targeting the B cell compartment and maintain functional persistence. This is not seen with autocar T cells. Moving to the clinical experience, I think one of the things that we're very excited about with our ability to translate on the 5-2-2 no-fly flu arm is that we're going to be able to look at ctDNA and see how the disease is modulated with each dose of 5-2-2 in an intact patient immune compartment and also look at the entire disease decrease over the treatment cycle. That will give us a hint of 5-2-2 activity without fly flu conditioning.

Bahram Valamehr: The $5 two co culture with additional <unk>, we can't continue targeting the T cell compartment and maintain functional persistence. This is not seen with Autocar T. This is not seen with NK cell.

Bahram Valamehr: Moving to the clinical experience I think one of the things that we're very excited about within with our ability translational under $5 due to the slight flu arm.

Bahram Valamehr: Going to be able to look at Cte DNA.

Bahram Valamehr: And see how the disease is modulator with each dose of <unk> and an intact patient immune compartments and also look at the entire disease.

Bahram Valamehr: Decrease over the treatment cycle, that's going to give us a hint of 5% to activity without buy through conditioning. We'll also look at the endogenous immune compartment and see how <unk> modulator and also look at the PK and an intact immune component with very sensitive assay. So we will hopefully see a lot of activity there and be able to.

Bahram Valamehr: We'll also look at the endogenous immune compartment and see how that's modulated, and also look at the PK in an intact immune compartment with a very sensitive assay. So we'll hopefully see a lot of activity there and be able to parlay that into an autoimmune disease. Yeah. Perfect. Thank you, guys. Thanks. What's the next question? Yigal Nochomovitz, Please go ahead.

Yigal Dov Nochomovitz: Parlay that into autoimmune disease.

Yigal Dov Nochomovitz: Yeah perfect. Thank you guys.

Bahram Valamehr: Thanks.

Yigal Dov Nochomovitz: The next question comes from Yigal <unk> with Citi. Please go ahead.

Yigal Dov Nochomovitz: Hi Tim, this is Amin Ansari Yigal. Thank you for taking our questions. We had a couple.

Yigal Dov Nochomovitz: Hi Tech initiatives on for Yigal. Thank you for taking our questions. You had a couple first on FTE <unk> emission patient cases studies have shown.

Scott Walshco: First, on FT819, you mentioned patient case studies have shown secondary and tertiary tissue trafficking and infiltration. Are you doing tissue biopsies here? Sure.

Amin Ansari: I've shown secondary and tertiary tissue trafficking infiltration.

Amin Ansari: Are you doing tissue biopsy here.

Bahram Valamehr: So we do show primary, secondary, and tertiary activity. For primary activity, we show that we have persistence in the bone marrow, and that correlates with reduction and elimination of CLL-positive cells. And this is based on full cytometry. So we show persistence and infiltration in the bone marrow and clearance of the disease. In our secondary, for the lymphoid, we have biopsies of the lymphoid tissues, and we can show that the population is reduced.

Amin Ansari: Sure. So so we do show a primary secondary and tertiary activity for the primary.

Bahram Valamehr: We showed that we have persist.

Bahram Valamehr: Persistence in the bone marrow and that correlates with reduction and elimination of CLO positive cells and this is based on flow cytometry. So we show.

Bahram Valamehr: Persistence and infiltration in the bone marrow and clearance of disease.

Bahram Valamehr: And our and our secondary for the limit for the lymphoid we have biopsy.

Bahram Valamehr: Lymphoid tissues, we have biopsies, there and we can show that the population is reduced and for tertiary. The example, we used in our presentation as lever and pets pet score, which correlates to PK. So we're able to through different methods, where there is direct detection of cell or.

Bahram Valamehr: And for tertiary, the example we use in our presentation is liver and PET score, which correlates to PK. So we're able to, through different methods, whether it's direct detection of cells or proxy detection of cells, be able to show that we are able to have activity in both primary, secondary, and tertiary tissues. Okay, great. That makes sense.

Bahram Valamehr: Proxy detection of cells to be able to show that we are able to have activity and with primary secondary and tertiary tissues.

Speaker Change: Okay, great that makes sense.

Scott Walshco: And then the second question, it's more of a general question, given you're planning to file an IMD-IV, FK522 for autoimmune, how should we think about the expectations for efficacy here? Are you hoping to see efficacy on par with CAR Ts, or is the main focus more like? Removing or lowering the preconditioning burden may be a little bit of a cost for efficacy.

Speaker Change: The second question one of the General question given you are planning to file an IND for ft 502 for octane yield.

Scott Walshco: How should we think about expectations on the efficacy here are you, hoping to see efficacy on par with car Ts or is it the main focuses more legs.

Scott Walshco: Removing or lowering the precondition embedded maybe.

Scott Walshco: Maybe a.

Scott Walshco: A little bit of a cost on efficacy.

Scott Walshco: Yeah, I think as we go into this study, we acknowledge efficacy is really important. I think at the end of the day, what's really exciting about cell therapy here in autoimmunity is the fact that, again, this is coming out of a German study. A single dose of CAR-T cell therapy has been able to generate an immune reset in patients that have had disease and refractory disease for a significant period of time, and that's been quite remarkable, and I think folks are very excited about that, and I think with respect to autoimmunity, efficacy is certainly going to be important, and we need to acknowledge that at some basic level, we need to be able to compete on eff

Speaker Change: Yes, I think as we're going into this study we acknowledge up because he is really important I think at the end of the day, which had been really exciting about cell therapy here in autoimmunity is the fact that again is.

Scott Walshco: Coming out of the German study.

Scott Walshco: Sure.

Scott Walshco: We have a single dose of car T cell therapy has been able to generate an immune reset in patients that have had have had disease in refractory disease for a significant period of time.

Scott Walshco: And thats been quite remarkable and I think folks were very excited about that and I think.

Scott Walshco: With respect to autoimmunity efficacy is certainly going to be important and we need to acknowledge that at some basic level, we need to be able to compete on efficacy that said.

Scott Walshco: That said... Autoimmunity is a very different setting than oncology, and I think safety is certainly going to be at a premium with respect to autoimmunity. I think one of the challenges that have already confronted the field is that PSY flu conditioning may not be well accepted by patients in the field of autoimmunity. And so I think safety is going to be critical.

Scott Walshco: Auto immunity is a very different settings in oncology.

Scott Walshco: And I think safety is certainly going to be at a premium.

Scott Walshco: With respect to autoimmunity.

Scott Walshco: I think one of the challenges that has already confronted the field is that psi fluid conditioning may not be well accepted by patients in the field of autoimmunity and so I think safety is going to be critical I think alternative regimens, where you can add on to standard of care treatments is going to be critical I think.

Daina Michelle Graybosch: I think alternative regimens where you can add on to standard of care treatments are going to be critical. I think reaching patients where they live and breathe, which is not at the academic CAR T cell centers, is going to be critical. And so I think there are a multitude of elements here that are going to be important in autoimmunity that are different than oncology. And I do think an off-the-shelf cell therapy has significant sort of attributes that can be very appealing for these people. Okay, I got it. Great. Daina Graybosch with Leering Partners.

Daina Michelle Graybosch: Reaching patients where they live and breathe, which is not at the academic car T cell centers is going to be critical.

Daina Michelle Graybosch: And so I think there are a multitude of elements here.

Daina Michelle Graybosch: That are going to be important in autoimmunity that are different than oncology and I do think an off the shelf cell therapy has significant sort of.

Daina Michelle Graybosch: Attributes that Ken.

Daina Michelle Graybosch: Very appealing for these patients.

Daina Michelle Graybosch: Okay got it great. Thank you very much for taking our questions.

Daina Michelle Graybosch: The next question comes from Diana <unk> with Leerink partners. Please go ahead.

Scott Walshco: Please go ahead. All right, so this is Jeff on behalf of Daina Graybosch. So we have two questions, and the first was... around the competitive landscape.

Daina Michelle Graybosch: So this is Jeff on for Dana.

Jeff: So you got two questions. The first was.

Jeff: Around competitive landscape Theres. Some recently published encouraging data with the firsthand in 2019.

Scott Walshco: There were some recently published encouraging data with the first gen CD19 by Blenatumumab. What was your view of that data, and what are you thinking about? T-cell engager competition overall for autoimmune disease given that the modality addresses many of the same challenges of AutoCard T that your off-the-shelf programs do. And then, looking at BCMA and your plans for a next-gen program there, do you expect to use the ADR modality there? And is that sufficient? Or are you looking at other edits?

Scott Walshco: Bayou blend Timna Nab what was your view of that data and how you're thinking about T cell engagement competition overall for auto immune disease, given that the modality addressed.

Scott Walshco: Addresses many of the same challenges of auto car T that you're off the shelf program soon and then.

Scott Walshco: Kind of <unk> and your plans for <unk>.

Scott Walshco: Nextgen program there.

Scott Walshco: We expect to use the ADR modality Darrin is that decision are you looking at.

Scott Walshco: And what do you think BCMA adds? Thank you. Thank you. Thank you.

Scott Walshco: Other edits and when do you think these he may add that you wouldn't already achieved but youre CD 19 program. Thank you.

Scott Walshco: Yeah, so on your sort of general question around CB19 engagers, I think we're approaching the autoimmunity space with eyes wide open with respect to the disruptive potential of CD19 engagers. And ultimately, as we're thinking about the development of the autoimmunity space, we recognize the benefits that can be brought to patients potentially through the differentiating potential of the CD19 engager. We've obviously seen that play out in oncology. And as we think about it, we're thinking about, essentially, our target product profile.

Speaker Change: Yes, so on your sort of general question around CD 19.

Scott Walshco: <unk>.

Scott Walshco: I think we're approaching the autoimmune space.

Scott Walshco: Eyes wide open with respect to the disruptive potential of CD 19 engages and ultimately as we're thinking about the development of the autoimmune disease space.

Scott Walshco: Recognize.

Scott Walshco: The benefits that can be brought to patients potentially in differentiating potential of the CD 19, gauger, we've obviously seen that play out in oncology.

Scott Walshco: And as we think about it we were thinking about essentially our target product profile.

Scott Walshco: <unk> directly up against.

Scott Walshco: I'm going directly up again, what the value proposition of a T-cell engager is, and hence, that's how you will hear us obviously talk about, we talked about on the call today, how important we think it is to move away from side effects, to add on to standard of care treatments, to reach patients in the community setting, to minimize hospitalization, and to prioritize safety and efficacy. So I think we're going into this recognizing that T cell engagers will play an important role in treating patients with autoimmunity and developing target product profiles directly head-to-head again.

Scott Walshco: What the value proposition of the T cell engagement and that's how you will hear us obviously talk about and we've talked about on the call today. How important we think it is to move away from Cy flew to add on to standard of care treatments to reach patients in the community setting to minimize hospitalization.

Scott Walshco: And to prioritize.

Scott Walshco: Safety and efficacy.

Scott Walshco: So I think we're going into this recognizing that T cell engages will play an important role in treating patients with autoimmune and developing target product profiles directly head to head against those.

Scott Walshco: As it relates to <unk> I think just generally and this is not a comment specifically to <unk>, but I think we're very excited about the ADR technology, both with respect to its first assessment with 5% to two clinically, but I think.

Scott Walshco: And I'll, let Bob talk to it and correct me, if I'm wrong, but I think any product candidate youre going to see emerge from fate therapeutics from this point forward will incorporate ADR technology.

Scott Walshco: We absolutely believe that Conditioning Chemotherapy, Intense Conditioning Chemotherapy is, um... Ahead of the field of cell therapy, and we need to move beyond that. And we're excited to do that.

Speaker Change: We absolutely believe that.

Scott Walshco: Conditioning chemotherapy intense chemotherapy conditioning chemotherapy is.

Scott Walshco: A headwind for the field of cell therapy, and we need to move beyond that.

Scott Walshco: And we're excited to do that we're excited to pioneer that and we think we've put a tremendous amount of work both respect to research and innovation on how to achieve a new cell therapy treatment paradigm.

Scott Walshco: We're excited to pioneer that, and we think we've put a tremendous amount of work, both respect to research and innovation, on how to achieve a new cell therapy treatment paradigm with off the shelf. Great, thank you. Actually, just a quick follow-up on mitigating lymphodepletion. How does Bend and Mustine only compare to psychophosphamide only in terms of relative potency? And would you expect the same degree of, you know, CAR T, FTE 819 expansion in vivo and the same level of potency? As you kind of saw with the Benden-Mustaine examples.

Scott Walshco: With off the shelf cell phone.

Speaker Change: Great. Thank you.

Scott Walshco: Actually just a quick a quick follow up and the mitigating LIFO depletion.

Scott Walshco: Bendamustine only compare to cyclophosphamide only in terms of relative potency.

Scott Walshco: And would you expect the same degree of.

Scott Walshco: Car T. SD 809 expansion in vivo in the same level of potency as you kind of saw with Bendamustine examples.

Scott Walshco: Yeah, I think it's... There's some data on this, right? There's some data out there that certainly combine in the field of oncology and CAR T cell therapy that has done work. Comparing Thigh Flu Conditioning to Ben DeMonte. And I think, generally speaking, it's been demonstrated that bendamustine can be an effective alternative treatment conditioning regimen for CAR T cell therapy. Bendamustine is in the same chemical class as cyclophosisphamide.

Speaker Change: Yes, I think.

Scott Walshco: I think it is.

Scott Walshco: There is some data on that right. There is some data out there that certainly combines in the field of oncology and car T cell therapy that has done.

Scott Walshco: Work.

Scott Walshco: Comparing by flu conditioning.

Scott Walshco: <unk> Bendamustine.

Scott Walshco: And I think generally speaking.

Scott Walshco: It's being demonstrated that Bendamustine hendi.

Scott Walshco: Specter of alternative treatment conditioning regimen for car T cell therapy.

Scott Walshco: Bendamustine is in the same chemical class as cyclophosphamide.

Michael Eric Ulz: We do have experience, as I mentioned, with Bendamustine as a stand-alone conditioning agent without flu therapy. And so, we're fairly confident that our programs can, FJ19 can perform with cyclophosisphamide. Great, thanks for taking our questions. The next question comes from Mike Ulz with Morgan Stanley. Please go ahead.

Scott Walshco: We do have experience as I mentioned with Bendamustine as a stand alone conditioning agent without fludarabine.

Michael Eric Ulz: So we're fairly confident.

Michael Eric Ulz: <unk>.

Michael Eric Ulz: Programs can <unk> can perform with cyclophosphamide.

Michael Eric Ulz: Okay.

Michael Eric Ulz: Great. Thanks for taking my questions.

Michael Eric Ulz: Okay.

Michael Eric Ulz: The next question comes from Michael <unk> with Morgan Stanley. Please go ahead.

Scott Walshco: Hi, this is Roy on behalf of the company. Can you just talk about what you, the first lupus patient treated with FT-819, and how safety compares to what's been seen in the autologous ED-19 therapies, and then can you also talk about what other autoimmune diseases you would consider expanding to? Yeah, I think I'll limit my comments to what we have disclosed to date. The patient is still in, and the person is this patient. It is still in the 30 day DLT assessment window.

Michael Eric Ulz: Hi, This is Robert on for Mike. Thanks for taking our questions can you just talk about what you've seen with the first lupus patients treated with <unk> hundred nine.

Scott Walshco: And how safety compares to what's been seen in the autologous <unk> thousand 19 therapies.

Scott Walshco: And then can you also talk about what other autoimmune diseases.

Scott Walshco: If you would consider expanding too thank you.

Speaker Change: Yeah, I think I'll limit my comments to what we disclosed to date the patient is still in the first lupus patients.

Scott Walshco: Still is in the 30 day DLT assessment window.

Scott Walshco: I can absolutely say that the patient was discharged after three days of hospitalization. So it was a three-day hospitalization stay. It was uneventful, and there were no notable adverse events.

Speaker Change: Can absolutely say that patience.

Scott Walshco: <unk> was discharged after three days of hospitalization. So was a three day hospitalization stay it was an eventful and there were no notable adverse events.

Scott Walshco: The patient does still remain, though, in the 30-day DLT assessment. With respect to expansion into other indications in autoimmunity, you know, we are doing a fair bit of work assessing that opportunity. Obviously, one of the elements of assessment is looking where others have established themselves, and this is primarily coming out of the German study, but also the field of allogeneic stem cell transplantation, looking at where there's been success with other B cell mediated diseases with either transplant or from the German group in the early seminal data. I'll leave it at that.

Scott Walshco: The patient does still remain though in these 30 day DLT assessment pointed out.

Scott Walshco: With respect to expansion into other indications in autoimmunity.

Scott Walshco: We are doing.

Scott Walshco: A fair bit of work assessing that opportunity obviously one of the <unk>.

Scott Walshco: Elements of assessment is looking.

Scott Walshco: Our others have established and this is primarily coming out of the German study, but also the field of allogeneic stem cell transplant.

Scott Walshco: Looking at where other b cell, there's been success with other b cell mediated diseases with either transplant or out of the German group.

Scott Walshco: The early.

Scott Walshco: Seminal datasets.

Scott Walshco: Ill leave it at that.

Speaker Change: Thank you.

Scott Walshco: The next question comes from Lee <unk> with Cantor Fitzgerald. Please go ahead.

Operator: Thank you. The next question is Lee Watsik with Cantor Fitzgerald, please go ahead. Hey, good afternoon.

Lee Watsik: Thanks for taking the questions. Let me just follow up on what other indications you might go into, and this is Spec 4-522. I know, Scott, you mentioned that you're looking at multiple autoimmune diseases, so just wondering, since it's quite crowded in the room today, what are other, you know, indications that you might be considering, such as RA? And how do you think about 522 fitting with 819 in terms of which patients, which types of patients to go after? Sure. At this point, you know, we are doing a lot of work. I am not going to disclose our strategy at this point in time.

Lee Watsik: Hey, good afternoon, thanks for taking the question.

Lee Watsik: Follow up on.

Lee Watsik: One other indication going.

Lee Watsik: <unk> chemical.

Lee Watsik: Four two.

Lee Watsik: Finally, amongst some annual unlocking.

Lee Watsik: Multiple orphan lung diseases.

Speaker Change: Just wondering.

Lee Watsik: Quite crowded.

Lee Watsik: So just wondering what.

Lee Watsik: Sure.

Lee Watsik: <unk> you might be considering the Morningstar, Inc.

Lee Watsik: Yeah.

Lee Watsik: Kapow too.

Lee Watsik: <unk> eight <unk> nine in terms of which.

Lee Watsik: Which patients.

Lee Watsik: Which types of patients to go after.

Lee Watsik: Sure at this point, we are doing a lot of work not going to disclose our strategy at this point in time.

Scott Walshco: We are obviously doing a lot of work in thinking about our expansion strategy in autoimmunity. We are looking at areas where there has been clinical precedent for cell therapies, whether that be in transplantation or out of the first, datasets that are being generated, both in Germany as well as the initial sort of company initiatives or company programs. So not prepared to disclose today how we think about expanding our FT-819 IND into additional indications or the initial multi-indication study that we plan to submit four or five. Okay.

Lee Watsik: Obviously doing a lot of work in thinking about our expansion strategy in autoimmunity, we are looking at areas, where there has been clinical precedent.

Scott Walshco: <unk> cell therapies, whether that be in transplant or out of the first datasets that are being generated.

Scott Walshco: Both out of Germany as well as.

Scott Walshco: The initial sort of company.

Scott Walshco: Initiatives, our company program, so not prepared to disclose today, how we think about expanding our FTA 19, IND into additional indications or the initial multi indication study that we plan to submit for five years.

Scott Walshco: And then maybe just wondering if you can just comment on your expectation for patient enrollment in the A1-9 study. It seems like you can dose the patient fairly quickly. And then it seems like you are going to, you know, amend the protocol to allow some alternative conditioning regimens. So do you think that might drive some of the traction with the site investigators?

Scott Walshco: Okay.

Speaker Change: And then maybe just wondering if you can just comment on your expectation for the patient enrollment in a one nine that it seems like you.

Scott Walshco: You can count the patient Sally quickly.

Scott Walshco: And then as things like you are going to amend the protocol to allow some are trying to conditioning regimen. So do you think that might drive that.

Scott Walshco: That traction with the site investigators.

Scott Walshco: Yeah, specifically, we have guided to three to five patients, an update on three to five patients in the 819 study by the end of this year. We've also guided to, and we discussed it on the call, that we are looking to utilize Cytoxan only as a third potential regimen for treating patients, so CyFlu or Benda or Cytoxan only. We do think that, and I think there's been discussion about this, that PsyFlu potentially is a barrier to treating patients with autoimmunity. These patients aren't cancer patients. They don't deserve to be treated like cancer patients.

Scott Walshco: Yeah.

Scott Walshco: Specifically, we have guided to 3% to five patient an update on three to five patients in the <unk> hundred 19 study.

Scott Walshco: By the end of this year, we've also guided to when we discussed it on the call that we are looking to.

Scott Walshco: Utilized by Thomson only as a third potential regimen for treating patients So XI flu.

Scott Walshco: <unk> or bend or site talks and only.

Scott Walshco: We do think that.

Scott Walshco: And I think there's been discussion about this that Si flu potentially is a barrier to treating patients with autoimmune disease.

Scott Walshco: These patients arent oncology patients they don't deserve to be treated like oncology patients and so I do think moving away from Si flu as a conditioning regimen is going to be critical to really capturing the potential of cell therapy in autoimmunity, and we look to pioneer in that.

Scott Walshco: And so I do think moving away from PSY-Flu as a conditioning regimen is going to be critical to really capturing the potential of cell therapy and autoimmunity, and we look to pioneer that. Thank you. The next question comes from Kara Bancroft. Please go ahead.

Tara A. Bancroft: Thank you.

Scott Walshco: The next question comes from Tara Bancroft with TD Cowen. Please go ahead.

Tara A. Bancroft: Hi there, this is Greg speaking on behalf of Tara. I'm wondering if you can give us any timeline for when we can expect clinical data in lupus for 899. Sure. In the prepared remarks, we guided to an update on the first three to five patients with FTA-19 in SLE by the end of this year. Okay, great. The next question comes from Ben Burnett with Stiefel. Please go ahead. Hi, this is Carolina Ibanez-Bentoso on behalf of BEMfornet.

Scott Walshco: Hi, there. This is Greg speaking on behalf of Tyra Im wondering if you can give us any timeline for when we can expect clinical data in lupus for 2019.

Carolina Ibanez: Sure in the prepared remarks, we've guided to an update on the first three to five patients with FCA 19 in SLE by the end of this year.

Carolina Ibanez: Okay, great. Thank you.

Tara A. Bancroft: Sure.

Carolina Ibanez: The next question comes from Ben Burnett with Stifel. Please go ahead.

Carolina Ibanez: Hi, This is currently nine venue.

Carolina Ibanez: On for Ben Bernanke. Thank you for taking our question.

Scott Walshco: Thank you for taking our question and congratulations on all your progress. On the ex vivo data for ST819 on the pre-treatment sample from the SLE patient, what do the E.T. ratios mean?

Scott Walshco: Good evolution from an ongoing progress.

Carolina Ibanez: On the ex vivo data.

Scott Walshco: Sure.

Carolina Ibanez: 1819 on Dave Friedman sample from the SLE patients.

Speaker Change: Key ratios shown imply about beneficiary.

Carolina Ibanez: And expansion, thank you need to achieve to get that data.

Scott Walshco: <unk>.

Ben Burnett: [inaudible] Visceral Depletion at the End of the Carve in Vivo in DSLV. I'm happy to answer that question, and I'll use some math here, so please forgive me if I start getting a little hypothetical. But what we show in the data is that at 2 to 1 ET ratio, we effectively eliminated all B cells that were in the PBMC compartment from the patient. If you were to think about the disease burden in autoimmune and specifically SLE, we anticipate somewhere around 100 to 300 million disease B cells residing within a patient.

Carolina Ibanez: B cell depletion at the end of the cars in in vivo in the SMA patients.

Speaker Change: I'm happy to answer that question and I'll use some math here. So please forgive me if I start getting a little hypothetical but.

Ben Burnett: So what we show and the data is that at 2% <unk> ratio, we effectively eliminated all b cells that were in the <unk> compartment from the patient.

Ben Burnett: If you were to think about the disease burden and other units, specifically <unk>, we anticipate somewhere around $100 million to $300 million disease, b cells residing within a patient.

Ben Burnett: So, if we're effectively clearing around almost all cells at 2 to 1, but pretty much over 95% at 1 to 1, our current dose of 260 million falls right smack in the middle of an effective dose that we see in vitro. So, to answer your question specifically, we're eliminating all B cells at 2 to 1, over 90% at 1 to 1, and that should give us confidence that the current dose is basically on par to match that in the patient setting at 360 million. Okay. Pretty helpful. Thank you. What's the next question?

Ben Burnett: So for effectively clearing around.

Speaker Change: Almost all cells at two to one but pretty much over 95% at one to one hour.

Ben Burnett: Our current dose of $260 million falls right smack in the middle of an effective dose that we see in vitro. So.

Ben Burnett: To answer your question, specifically, we are eliminating all T cells at two to one and over 90% at one to one and that should give us confidence that the current dose.

Speaker Change: It's basically on par to match that in the patient setting at $360 million.

Speaker Change: Okay great.

Speaker Change: Thank you.

Ben Burnett: Sure.

Ben Burnett: The next question comes from Peter Lawson with Barclays. Please go ahead.

Bahram Valamehr: This is Peter Lawson with Barclays. Please go ahead. Hi, this is Alex on behalf of Peter.

Peter Richard Lawson: Thank you for taking the question. Just wondering if, if you cap the data a little bit, the ASGCT data, when you're looking at preclinical and translational data for 819. NK-Cell Program, any notable differences you see?

Bahram Valamehr: Hi, This is Alex on for Peter Thank you for taking the question just wondering if you could maybe just recap the data a little bit.

Peter Richard Lawson: <unk> data when you look at the the.

Alex: Preclinical and translational data for 809 versus 52 so.

Speaker Change: <unk> program.

Alex: Just the NK cell program.

Alex: Notable differences you see in terms of.

Bahram Valamehr: tissue distribution, and B-cell depletion. Sure, I can answer that question. So, FT-819 and FT-522 obviously are very different. FT-522 not only has the ADR technology but also has the IL-15 receptor fusion. So, preclinically, we see very good biodistribution with FT-522 because it very much doesn't need antigen for expansion and doesn't need cytokine for expansion. So, we see very good biodistribution. Obviously, it has the ability to be combined with a monoclonal antibody, and so we see that as well.

Alex: Tissue distribution, b cell depletion or b cell reconstitution.

Speaker Change: Sure I can answer that question.

Bahram Valamehr: <unk> hundred nine ft, 52, obviously, a very different ft 500, <unk> not only has the ADR technology, but also have the IL 15 receptor fusion. So pre clinically we see a very good bio distribution with ft 500 to two because it's very much doesn't need antigen for expansion doesn't need cytokine for expansion.

Bahram Valamehr: Either we enhance activity against a specific cell, like, for example, targeting CD19 and CD20 at the same time, or going after other cell types that have eliminated the CD19 expression and are only expressing, for example, CD38. So, that multi-antigen perspective also comes through with FT-522. And with FT-819, having a 1XX car in the track locus is a very potent car product.

Bahram Valamehr: So we see very good bio distribution, obviously it has the ability to be combined with a monoclonal antibody. So we see that as well either we enhanced activity against the specific cell like for example, targeting CD 19, and CD 20 at the same time, we're going after other cell types that have eliminated the Citi 19 expression in our own.

Bahram Valamehr: Expressing for example, CD 38, so that multi antigen perspective also content through with Ft 502.

Scott Walshco: And so, we see that when we go head-to-head against AutoCard T in preclinical studies. And so, we see very potent activity with FT-819, as I mentioned earlier as well. So, those are the main differences in terms of the behavior of these cells.

Scott Walshco: With FTE 819, having a <unk> car in the Trac locus is a very potent.

Scott Walshco: Car product and so we see that when we go head to head against auto car T. In preclinical studies, so we see very potent activity.

Scott Walshco: <unk> hundred nine as I mentioned earlier as well. So those are the main differences in terms of behavior of the cells we have.

Scott Walshco: We have a product that's ADR, that does not need conditioning, and can go multi-antigen targeting, and another product that's very potent against CD19. And I think one of the comments I would just add on to that is FT819, with respect to its manufactured phenotype, has a high expression of CXCR4. And so we've seen very good sort of homing and trafficking and infiltration of secondary and tertiary tissue in preclinical studies. Okay, thank you. And I guess does that have a target in the auto? Yeah, yeah.

Scott Walshco: A product that's ADR that design, a conditioning and can go multi antigen targeting and another product is very potent against CD 19.

Scott Walshco: And I think one of the comments I would just add on to that is F 2019 with respect to what's manufactured phenotype has high expression of <unk> four.

Scott Walshco: And so we've seen very good steward.

Scott Walshco: Homing in trafficking and infiltration of secondary and tertiary tissue in preclinical studies.

Speaker Change: Good point.

Scott Walshco: Okay. Thank you and I guess does that have.

Scott Walshco: Any implications for which type of indications you could target Cindy autoimmune autoimmune setting.

Yanan Zhu: I mean, we're looking at it. We are still doing work on thinking about exactly how to expand and what indications are going to be prioritized with 819 and 522. We are ready, and we are preparing to expand the 819 IND to consider additional indications, and obviously, we've discussed filing a multi-indication IND for 522. So, a lot of work is going on. Stay tuned there for that. The next question. Yanan Zhu with Wells Fargo Securities.

Scott Walshco: Yeah Yeah.

Scott Walshco: It's something we're looking at I mean, we're still doing work on thinking about.

Yanan Zhu: Exactly how to expand and what indications are going to be prioritized with <unk> 19, and <unk> two.

Yanan Zhu: We are prepared and now we are preparing to expand the <unk> 19 IND.

Yanan Zhu: To consider additional indications and obviously, we've discussed filing a multi indication.

Yanan Zhu: And for <unk>, So a lot of work and going on stay tuned there on that front.

Yanan Zhu: The next question comes from your non Jew with Wells Fargo Securities. Please go ahead.

Scott Walshco: Please go ahead. Great. Thanks for taking our questions. You know, to follow up on a prior question about the bispecific literature, recent literature, just wondering, do you have an opinion on the depth of B cell depletion a bispecific antibody can achieve compared with cellular therapy? And, you know, do you foresee for the bispec, if it becomes a modality, would it be a repeat administration at a certain time interval? Could that be, you know, viable or competitive with cellular therapy?

Yanan Zhu: Great. Thanks for taking our questions.

Scott Walshco: Following up on a prior question about the Bispecific literature recent literature.

Scott Walshco: Just wondering do you have a view on the depth of B cell depletion a bi specific antibody can achieve.

Scott Walshco: Apparently the cellular therapy and.

Scott Walshco: Do you foresee for the bi spec if it becomes a modality would it be.

Scott Walshco: Repeat administration at certain time interval.

Scott Walshco: Could that be.

Scott Walshco: A viable competitive with that of a therapy and lastly, four eight.

Scott Walshco: And lastly, for 819, do you foresee the potential possibility of additional doses at a certain time interval and whether that could be part of the product profile and whether you might even be considering looking at that in a current study? Sure.

Scott Walshco: <unk> hundred nine.

Scott Walshco: Do you foresee.

Scott Walshco: Potential possibility.

Scott Walshco: Additional doses.

Scott Walshco: At a certain time interval.

Scott Walshco: And weather.

Scott Walshco: That could be part of the product profile.

Scott Walshco: You might even be considering and looking at.

Scott Walshco: At current study thanks.

Scott Walshco: So, forgive me, I am not an expert on the bispecific engagers, and so I can't talk in an informative way about the depth of B-cell depletion that's been seen or achieved with the B-cell engagers. Obviously, in the setting of oncology, the T-cell engagers have generated complete responses. So again, we are going into the field of autoimmunity, recognizing that T-cell engagers can be an attractive modality and have the potential to drive an immune reset. Whether that's achievable, what the duration of that looks like, what the side effect profile of that looks like, how many doses, all that's TBD. We're very early, I think, just generally in the field of autoimmunity. That said, I think one of the problems is.

Speaker Change: Sure so.

Speaker Change: Forgive me I am not an expert on.

Scott Walshco: On the bi specific engages and so I can't talk in an informative way about the depth of B cell depletion. That's been seen are achieved with the b cell engages obviously in the setting of oncology.

Scott Walshco: The.

Scott Walshco: T cell engagements have generated complete responses.

Scott Walshco: Again, we are going into the field of autoimmunity, recognizing that T cell engaging <unk>.

Scott Walshco: NDAA attractive modality and have the potential to drive an immune reset.

Scott Walshco: Whether that's achievable.

Scott Walshco: What the duration of that looks like with the side effect profile that looks like how many doses all of that's TBD. We're very early I think just generally in the field of autoimmunity.

Scott Walshco: That said I think one of the.

Scott Walshco: Potential strengths of an engager are that it can be multi-dosed. And I do think from our standpoint as a company, we've always discussed the fact that in off-the-shelf cell therapy, we do think it has multi-dosing potential. I think multi-dosing potential can be hindered by side effects. Hence, as we discussed, we think it's important to think about both 819 and 522 being developed as add-on strategies to standard regimens that are used today to treat patients in a community setting with autoimmune disease. And I think you will see us continue to move in that direction where we are thinking about delivering and dosing cell therapies as if they were monoclonal antibodies.

Scott Walshco: Potential strength of and engage or is that it can be multi dosed and I do think from our standpoint as a company. We've always discussed the fact that an off the shelf cell therapy, we do think has multi dosing potential.

Operator: Very helpful. Here's the next question. Please go ahead.

Operator: I think multi dosing potential can be hindered by size fleet conditioning, hence.

Operator: Hence as we discussed we think it's important to think about both 2019 and $5 two two.

Operator: <unk> being developed as an add on strategies to standard regimens that are used today to treat patients in the community setting with autoimmune disease.

Operator: And I think you will see us continue to move in that direction, where we are thinking about delivering and dosing cell therapies as if they were a monoclonal antibody.

Speaker Change: Got it very helpful. Thank you.

Operator: The next question comes from Bill Maughan with Canaccord Genuity. Please go ahead.

Operator: Hi, thanks for taking the question. So... Let's follow up on this morning's 819 data. All the PK, obviously, was positive, but thinking about translating that from an oncology patient to an autoimmune patient when antigen-dependent expansion is a key part of the PK of a CAR-T cell therapy, I'm just wondering how you think about translating from one population to another. Yeah, I think, you know, there's a lot we don't know with respect to how the two diseases are going to translate.

Speaker Change: Hi, Thanks for taking the question so.

Operator: To follow up on this mornings 819 data all of the PK, obviously was positive but thinking about translating that from.

Operator: From an oncology patient two in autoimmune patients when antigen dependent expansion is a key part of the PK of our car T cell therapy.

Operator: Just wondering how you think.

Operator: About being able to translate.

Operator: From that from one population to the next.

Speaker Change: Yes, I think.

Operator: A lot we don't know with respect to how the two diseases are going to translate I think.

Speaker Change: What we have certainly seen with the PK is that we had seen CD 19 mediated expansion that is dose dependent.

Operator: Certainly the mechanism of action or one of the Mec in key mechanisms of action in autoimmunity is being able to recognize and target and eliminate CD 19 positive T cells.

Operator: I don't necessarily presume that.

Operator: Actually the PK profiles are necessarily going to be the same in oncology versus auto immunity I think at the end of the day, what's obviously critical as <unk>.

Operator: The kinetics and depth of B cell depletion.

Speaker Change: Okay. Thank you.

Scott Walshco: I think what we have certainly seen with the PK is that we have seen CD19-mediated expansion that is dose-dependent. Certainly, the mechanism of action, or one of the key mechanisms of action in autoimmunity, is being able to recognize and target and eliminate CD19 positive B cells. So I don't necessarily presume that the PK profiles are necessarily going to be the same in oncology versus autoimmunity. I think at the end of the day, what's obviously critical is the kinetics and depth of B cell depletion. Thank you. The next question comes from Ethan Markowski with Needham and Company. Please go ahead. Hi, this is Ethan on behalf of Gill Bloom.

Operator: The next question comes from Eastern Mark Calfskin with Needham and company. Please go ahead.

Ethan Markowski: Thank you for taking our question. So I'm just looking at the charts and the ASTCT data, and I think you guys clearly show that FT522, exhibits deeper B-cell depletion than FT, F9, and 6. But it looks like FT819's graph, at least the bar graph in depletion, is very similar to FT596 with some cells coming back up in the mid-to-end of the cycle. I was wondering first. [inaudible] www.kenhub.com And then also, just from a cost savings perspective, I know you're no longer.

Ethan Markowski: Yes, Hi, this is Ethan on for Joel Blum. Thank you for taking our question.

Ethan Markowski: So I'm just looking at.

Ethan Markowski: The chart familiar GCT data.

Ethan Markowski: You guys clearly show that.

Ethan Markowski: <unk> to.

Ethan Markowski: Demonstrates deeper B cell depletion then FTE at nine six.

Ethan Markowski: But it looks like ft, nine graph at least a bar graph in depletion is very similar to ft 506 with themselves.

Ethan Markowski: Coming back up in the mid teens and of the cycle I was wondering first.

Ethan Markowski: How important.

Ethan Markowski: This complete responses.

Ethan Markowski: From cells coming back at the end is clinically relevant.

Ethan Markowski: And then also just from a cost savings perspective, I know you are no longer.

Scott Walshco: Thank you for taking our time. Yeah, so on the last question with respect to clinical development and multiple myeloma, obviously, there are patient costs associated with clinical development. We are, while we are not advancing 5, 7, 6 into dose expansion, we are in multiple myeloma. We are certainly expanding the development of autoimmunity. And so, you know, in terms of changing cash burn, I don't think we're thinking about that as much.

Ethan Markowski: Planning to move forward in multiple myeloma and do cell lymphoma. So wondering if that has any impact in a positive way on near term R&D spend.

Speaker Change: Thank you for taking my question.

Scott Walshco: Yes.

Scott Walshco: On the last question with respect to clinical development of multiple myeloma, obviously, there are patient costs associated with clinical development.

Scott Walshco: While we are not advancing $5 76 in two dose expansion. We are in multiple myeloma, we're certainly expanding development in autoimmunity and so in terms of changing cash burn I don't think we're thinking about that.

Scott Walshco: That as.

Scott Walshco: Enhancing or Saving or Reducing BUM or certainly investing in it. As it relates to B-cell depletion, I think, you know, keep in mind with both 819 as well as 522, we're seeing very, very low levels of cells in many instances, and I'll let Bob talk about it, you know, below the lower limit of sort of detection. And so when we start getting into very, very low levels, you start to And I don't believe, at least we think, that we're seeing different levels of depletion with 819 versus 522. I'll let Bob comment on that.

Scott Walshco: Enhancing our <unk>.

Scott Walshco: Savings are reducing bump or certainly investing in oil.

Scott Walshco: Sure.

Scott Walshco: As it relates to B cell depletion I think keeping keep in mind with both 819 as well as $5 two two.

Bob: We are seeing very very low levels.

Speaker Change: <unk> sells.

Scott Walshco: In many instances and I'll, let Bob talk about it below lower than the limit of.

Scott Walshco: Detection and so when we start getting into very very low levels, you start to get into sort of.

Scott Walshco: Discussion about whether it is a significant significant or not and I don't believe at least we think that we're seeing different levels of depletion with a 19 versus $5. Two I'll, let Bob comment on that I will say just to be really clear <unk>.

Scott Walshco: I will say, just to be really clear, the 819 data set is over a much larger data set of patients. I think we used 23 patients with B-cell lymphoma for that data set. Some of those patients had, you know, relatively high B-cell counts going into the study. In fact, we noted that there were certain patients that had super physiological levels of B-cell counts that we were able to deplete with FTA-19. The 522 data set is, I think, only on two patients, and their B-cell counts generally were lower at baseline compared to the totality of the, I think, I'll let Bob talk on that, but I think generally speaking, what we've seen with respect to B-cell reconstitution from the SHET data is B-cell reconstitution actually can happen as, for instance, as early as the third or fourth week and can happen as late as four months, but I'll let Bob sort of finish up on that if I missed anything.

Scott Walshco: 819 dataset is over a much larger data set of patients.

Speaker Change: I think we used 23 patients with B cell and T cell lymphoma for that data set some of those patients had <unk>.

Scott Walshco: Relatively high B cell counts going into the study in fact, we noted that there were certain patients that had super physiological levels of B cell counts that we were able to deplete with FCA 19 decides to two dataset is.

Bob: We are only on two patients.

Bob: And they are B cell counts generally were lower at.

Scott Walshco: At baseline compared to the totality of the 19 patients.

Scott Walshco: Jeff I'll, let Bob talk but yet on that but I think generally.

Scott Walshco: Generally speaking what we're seeing with respect to B cell reconstitution from the shirt data is b cell reconstitution actually can happen as for instance, as early as the third or fourth week and can happen as late as four months.

Scott Walshco: But I'll, let Bob sort of finish up on that if I missed anything no I think you will cover that when.

Scott Walshco: No, I think you covered it well when discussing 819. As Scott mentioned, that was a large number of patients, but it fell pretty much in line with showing very good B-cell depletion over the treatment cycle, and B-cell recovery was seen in some of the patients. Now, keep in mind, this is oncology, so what's coming back up could be a, you know, lymphoma cell or something. So we're in a much more aggressive stage than what SHED shows, but as Scott mentioned, what SHED shows is that B-cells do come back from 30 days to 180 days.

Scott Walshco: When discussing a 109 as Scott mentioned of the large number of patients, but it felt pretty much in line with showing very good b cell depletion over the treatment cycle and B cell recovery was seen in some of the patients now keep in mind. This is oncology, so what's coming back up could be a lymphoma cell or something.

Scott Walshco: So we're in a much more aggressive stage then what's sheds showed but as Scott mentioned.

Scott Walshco: What <unk> shown is that T cells do come back from 30 days to 180 days. So every patient treated all 15 and shed data had I believe day 180.

Scott Walshco: So every patient treated, all 15 in SHED's data, had, I believe, day 180 full recovery of B-cells. So 819 is very much in line with what SHED showed. Now, with 522, you're bringing up a very good point, and I think part of that has to do with the fact that it's being combined with a toxin. So this is a kind of a one-two punch that we're seeing. Again, two patients; I'm not going to sit here and speculate too much on it, but you are seeing the power of CAR plus HNCD-16 in these settings, and I think both programs' data has been very encouraging so far.

Scott Walshco: A full recovery of B cell. So 809 is very much in line with what shirt show now with 532, you're bringing up at very good point and I think part of that has to do with the fact that it's being combined with Rituxan. So that this is a.

Scott Walshco: Kind of.

Scott Walshco: <unk> punched ever seen again, two patients I'm not going to sit here and.

Scott Walshco: Speculate too much on it but you are seeing the power of car plus agent CD 16 in these settings and <unk>.

Scott Walshco: And I think both programs are data has been so far very encouraging.

Scott Walshco: And, Ethan, I'll just pick up on Scott's comments qualitatively. I agree the mix of the business will change through the course of the year, but if you look at the first quarter, we had, you know, roughly $52, $53 million in GAAP operating expenses and about $37 million in cash burn. That's been pretty consistent for the last couple of quarters.

Scott Walshco: And even I'll just pick up on Scott's comments qualitatively I agree the mix of the business will change through the course of the year, but if you look at the first quarter, we had roughly 50 $253 million in GAAP operating expenses and about $37 million in cash burn that's been pretty consistent for the last couple of quarters. So even though we have one or two programs winding down. The hope is that now that we have first patient.

Scott Walshco: So, even though we have one or two programs winding down, the hope is that now that we have the first patient dose and we're beginning to clear dose levels in certain programs, that will pick up throughout the year. So, I expect that those numbers I just quoted, you know, the $53 million in GAAP operating expense and the $37, $38 million in cash burn, effective cash burn for the quarter, to remain fairly consistent.

Scott Walshco: Dose can we're beginning a clear dose levels in certain programs, that's going to pick up throughout the year. So I expect that those numbers I just quoted was $53 million on the GAAP operating expense from 3700 $38 million on the cash burn effective cash burn for the quarter to remain fairly consistent I'm more than happy to invest find these clinical programs. So if that picks up too.

Scott Walshco: Call It circa 40 million on a cash burn basis, but we feel pretty good about where we are just the mix of businesses will evolve, but that's a pretty good number to work with for the rest of the year.

Speaker Change: Thank you very helpful.

Scott Walshco: This concludes our question and answer session I would now like to turn the conference back over to Scott <unk> for any closing remarks.

Scott Walshco: Thank you. Thank you for everyone today for all your good questions on the <unk> data I appreciate all the input and thought and.

Scott Walshco: Speak too soon thank you.

Speaker Change: The conference has now concluded. Thank you for attending today's presentation you may now disconnect.

Scott Walshco: Yeah.

Scott Walshco: [music].

Scott Walshco: Okay.

Scott Walshco: [music].

Speaker Change: Welcome to the fate Therapeutics first quarter 2024 financial results conference call. At this time all participants are in listen only mode. This call is being webcast live on the investors section of fates website at fate Therapeutics dotcom.

Scott Walshco: As a reminder, today's call is also being recorded.

Scott Walshco: I would now like to turn I would now like to introduce Scott Wasco, President and CEO of fate Therapeutics. Please go ahead.

Scott Walshco: I'm more than happy to invest in these clinical programs. So, if that picks up to, you know, call it circa $40 million on a cash burn basis, but we feel pretty good about where we are, just the mix of the businesses will evolve, but that's a pretty good number to work with for the rest of the year. Thank you. Very helpful. This concludes our question and answer session. I would like to turn the conference back over to Scott Walshko for any closing remarks.

Scott Walshco: Thank you. Thank you to everyone today, for all your good questions on the ASGCT data. I appreciate all the input and thought.

Scott Walshko: Thank you.

Scott Walshko: Good afternoon, and thanks, everyone for joining us for the fate Therapeutics first quarter 2024 financial results call. Shortly after four P M eastern time today.

Scott Walshko: We issued a press release with these results, which can be found on the investors section of our website under press releases.

Scott Walshko: In addition, our Form 10-Q for the quarter ended March 31, 2024 was filed shortly thereafter and can be found on the investors section of our website under financial information.

Operator: Speak to you soon, thank you. The conference is now concluded. Thank you for attending today's presentation. [inaudible] ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? Fate Therapeutics First Quarter 2024 Financial Results Conference. At this time, all participants are enlisted. This call is being webcast live on the Investor Sections of FATE's website at www.fatetherapeutics.com, As a reminder, today's call is also. I would now like to turn, I would now like to.

Scott Walshko: 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 1095.

Scott Walshco: Scott Walshko, President and CEO of Fate Therapeutics, please go ahead. Thank you. Good afternoon, and thanks, everyone, for joining us for the Fate Therapeutics first quarter 2024 financial results call. Shortly after 4 p.m.

Scott Walshco: ET 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, 2024, was filed shortly thereafter, and can be found on the Investors section of our website under Financial Information. Before we begin, I would like to remind everyone that, except for statements of historical 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.

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

Scott Walshco: Please see the forward-looking statement disclaimer in the company's earnings press release issued after the close of market today, as well as the risk factors included in our Form 10-Q for the quarter ended March 31, 2025, that was filed with the SEC. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, as facts and circumstances underlying these forward-looking statements may change. Except as required by law, Fate Therapeutics disclaims any obligation to update these forward-looking statements to reflect future information, events, or circumstances.

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

Scott Walshco: As well as the risk factors included in our Form 10-Q for the quarter ended March 31, 2024 that was filed with the SEC today.

Scott Walshco: Except as required by law fate therapeutics disclaims any obligation to update these forward looking statements to reflect future information.

Scott Walshco: Or circumstances.

Scott Walshco: Joining me on today's call are Ed Dulac, our Chief Financial Officer, and Dr. Bob Valamehr, our Chief Research and Development Officer. We will focus today's remarks on the data presented today at the American Society of Gene and Cell Therapy Annual Meeting for our off-the-shelf FT819 CAR T-cell and FT522 CAR NK cell programs and discuss key program initiatives that we are pursuing to achieve therapeutic differentiation and In addition, we will highlight clinical readouts that we are projecting to achieve in 2024 across our IPSC product pipeline for the treatment of cancer and autoimmune disease. Finally, we will review our financial position, where our first quarter capital raise and strong cash balance have created operating runway into the second half of 2026.

Scott Walshco: Joining me on todays call are Ed do Lark, our Chief Financial Officer, and Dr. Bob <unk>, Our Chief Research and development Officer.

Scott Walshco: We will focus today's remarks on the data presented today at the American Society of gene and cell therapy annual meeting.

Scott Walshco: For our off the shelf FTA 19 car T cell and <unk> two car NK cell programs.

Scott Walshco: And discuss key program initiatives that we're pursuing to achieve therapeutic differentiation and improve patient outcomes in.

Scott Walshco: In addition, we will highlight clinical readouts that we're projecting to achieve in 2024 across our Ips C product pipeline for the treatment of cancer and autoimmune diseases.

Scott Walshco: Finally, we will review our financial position or.

Scott Walshco: For our first quarter capital raise and strong cash balance have created operating runway into the second half of 2026.

Scott Walshco: Beginning with FT-819, our off-the-shelf CD19-targeted CAR T-cell program, today, at the ASGCT annual meeting, we presented translational data from our FTA-19 Phase I study in relapsed refractory B-cell malignancies, which show that a single dose of FTA-19 exhibited multiple mechanisms of action implicated in generating an immune reset in patients with B-cell mediated The translational data supporting these mechanisms included rapid, deep, and sustained CD19-positive B-cell depletion in the peripheral blood; patient case studies of primary, secondary, and tertiary tissue trafficking, infiltration, and activity with CD19 positive B cell elimination in tissue; and patient case studies of plasma cell depletion and B-cell reconstitution, with recovery of naive B-cells and little to no recovery of activated memory B Notably, we also presented patient case studies demonstrating rapid, deep, and sustained B-cell depletion, although accompanied by clinical response, without the use of fluderabine as a conditioning agent.

Scott Walshco: Beginning with the FTA 19 are off the shelf CD 19 targeted car T cell program.

Scott Walshco: Today at the <unk> annual meeting, we presented translational data from.

Scott Walshco: From our FTA.

Scott Walshco: <unk> phase one study in relapsed refractory b cell malignancies, which show that a single dose of FCA 19 exhibited multiple mechanisms of action implicated in generating an immune reset in patients with b cell mediated.

Scott Walshco: Autoimmune diseases with.

Scott Walshco: Translational data supporting these mechanisms included rapid deep and sustained CD 19 positive b cell depletion in the peripheral blood.

Scott Walshco: Patient case studies of primary secondary and tertiary tissue trafficking infiltration and activity with CD 19 positive diesel elimination in tissue.

Scott Walshco: And patient case studies of plasma cell depletion and B cell reconstitution.

Scott Walshco: With recovery of naive b cells, and little to no recovery of activated memory b cells or plasma blasts.

Scott Walshco: Notably, we also presented patient patient case studies, demonstrating rapid deep and sustained b cell depletion occur.

Scott Walshco: Accompanied by clinical responses without the use of Fludarabine as a conditioning agent.

Scott Walshco: Collectively we believe these data support the disease modifying potential of FCA 19 for patients with B cell mediated autoimmune diseases.

Scott Walshco: To that end I am pleased to announce that the first lupus patient has been treated in our phase one autoimmune disease study of FDA 19.

Scott Walshco: This first patient.

Scott Walshco: 27 year old woman with refractory disease, despite having previously been treated with multiple standard of care therapies risk.

Scott Walshco: <unk> received conditioning chemotherapy.

Scott Walshco: <unk> by a single dose of FTA 19 at 360 million cells.

Scott Walshco: The patient was discharged after a three day hospitalization stay.

Scott Walshco: Without any notable adverse events.

Scott Walshco: At ASGCT today, we also presented promising data from a first-of-kind translational app, using a sample of the patient's blood obtained prior to the administration of conditioning chemotherapy, where we observed rapid and potent depletion of the patient's CD19 positive B cells in an ex vivo cytotoxicity assay with the FT819. It is worthwhile to note that treatment of this first patient occurred within weeks of site activation. We believe this patient experience exemplifies the potential of an off-the-shelf cell therapy to overcome challenges that may hinder autologous cell therapies in reaching patients with autoimmune diseases, including the need for Inflorescence, Complex Manufacturing and Treatment Logistics, and Extended Patient Hospitalization.

Scott Walshco: At <unk> today, we also presented promising data from a first of kind translational assay.

Scott Walshco: Using a sample of the patient's blood.

Scott Walshco: Pain prior to administration of conditioning chemotherapy.

Scott Walshco: Where we observed a rapid and potent depletion of.

Scott Walshco: The patients CD 19 positive b cells in an ex vivo cytotoxicity assay with FTA 19.

Scott Walshco: It is worthwhile to note that treatment of this first patient occurred within weeks of site activation.

Scott Walshco: Including the need for <unk>.

Scott Walshco: Complex manufacturing and treatment logistics and extended patient hospitalization.

Scott Walshco: Furthermore, since we have observed deep B-cell depletion, any clinical response, Without the use of fludarabine as a conditioning agent in our phase one study of FT-819 for B-cell malignancy, we believe FT-819 may have disease-modifying potential in autoimmunity using alternative conditioning regimens. We plan to amend the current clinical protocol for our Phase I autoimmunity study in the second quarter of 2024 to enable FT-819 administration with single-agent Cytoxan at the same dose used by rheumatologists for treatment of patients with autoimmune disease.

Scott Walshco: Furthermore, since we have observed deep b cell depletion and clinical responses without the use of fludarabine as a.

Scott Walshco: Conditioning agent in our phase one study of FCA 19 for B cell malignancies.

Scott Walshco: We believe the FCA 19 may have disease modifying potential in autoimmunity using alternative conditioning regimens.

Scott Walshco: We plan to amend the current clinical protocol for our phase one autoimmunity study.

Scott Walshco: In the second quarter of 2024.

Scott Walshco: To enable FCA 19 administration with single agent site toxin.

Scott Walshco: At the same dose used by Rheumatologists for treatment of patients with autoimmune disease.

Scott Walshco: We believe that an off-the-shelf add-on of FT-819 to commonly used treatment regimens may contribute to a highly differentiating patient experience. Dose escalation in our FT-819 Phase 1 study in relapsed refractory B-cell malignancies has now completed, where 43 patients were treated with a single dose of FT-819 at up to 1 billion cells without HLA matching. We observed clinical responses, including complete responses, in heavily pre-treated patients with aggressive disease, including in relapsed refractory large B-cell lymphoma patients that were previously treated with autologous CD19-targeted CAR T-cell therapy.

Scott Walshco: We believe that an off the shelf add on of FTA 19, two commonly used treatment regimens may contribute to a highly differentiating patient experience.

Scott Walshco: Dose escalation and our FTA 19 phase one study in relapsed refractory B cell malignancies has now completed.

Scott Walshco: We're 43 patients were treated with a single dose of FTE 19 at up to 1 billion cell without HLA matching.

Scott Walshco: We observed clinical responses, including complete responses in heavily pretreated patients with aggressive disease, including.

Scott Walshco: Including in relapsed refractory large b cell lymphoma patients that were previously treated with autologous <unk> thousand 19 targeted car T cell therapy.

Scott Walshco: The safety and tolerability profile of FT-819 was favorable, with no dose-limiting toxicities, no events of any grade of ICANs, or graft-versus-host disease, and a low incidence of only low-grade CRS. We believe the established clinical safety and tolerability profile of FT-819 is differentiated, and may also be of significant importance for treatment of patients with autoimmune disease. At this time, we intend to focus all further clinical development of FT819 exclusively on autoimmune diseases. Today, at the ASGCT annual meeting, we also presented data from our FT522 off-the-shelf CD19-targeted CAR and K-cell program, which is the first product candidate emerging from our IPSC product platform that incorporates our own immune defense receptor technology.

Scott Walshco: The safety and Tolerability profile of FTA 19 was favorable.

Scott Walshco: With no dose limiting toxicities.

Scott Walshco: No events of any grade of icons.

Scott Walshco: Graft versus host disease.

Scott Walshco: And low incidents of only low grade Crs.

Scott Walshco: We believe the established clinical safety and Tolerability profile of FTA 19 is differentiated.

Scott Walshco: And may also be a significant import for treatment of patients with autoimmune diseases.

Scott Walshco: At this time, we intend to focus all further clinical development of FTA 19 exclusively in autoimmunity.

Scott Walshco: Today at the <unk> annual meeting, we also presented data from our ft. Five two to off the shelf <unk> targeted car NK cell program.

Scott Walshco: Which is the first product candidate emerging from our Ips C product platform that incorporates our own immune defense receptor technology.

Scott Walshco: Today, the treatment course for administration of cell based Immunotherapies.

Scott Walshco: <unk>, both autologous and allogeneic cell therapies requires conditioning patients with chemotherapy.

Scott Walshco: Conditioning chemotherapy can induce toxicities.

Scott Walshco: In combination with standard of care treatments widely used in the community based settings.

Scott Walshco: And limit patient access and reach.

Scott Walshco: ADR technology incorporated into 522 is designed to enable effective treatment without the administration of conditioning chemotherapy to patients, which we believe has the potential to redefine the cell therapy treatment paradigm. We have previously presented preclinical data using cancer cell law, demonstrating that the co-culture of ADR-armed Corin K-cells with alloreactive T-cells promotes NK cell proliferation, enhances NK cell persistence, and increases anti-tumor activity, indicating that arming with AVR technology has the potential to enable effector cell function in the presence of an alloreactive system.

Scott Walshco: ADR technology incorporated into <unk>, two is designed to enable effective treatment without administration of conditioning chemotherapy to patients.

Scott Walshco: Which we believe has the potential to redefine the cell therapy treatment paradigm.

Scott Walshco: We have previously presented preclinical data using cancer cell lines, demonstrating that the co culture of ADR armed car NK cells with allo reactive T cells.

Scott Walshco: Promotes NK cell proliferation.

Scott Walshco: Enhances NK cell persistence.

Scott Walshco: <unk> increases anti tumor activity.

Scott Walshco: Indicating that our roaming with ADR technology has the potential to enable effector cell function in the presence of an allo reactive system.

Scott Walshco: Today, at the ASGCT annual meeting, we reported preclinical data using SLE-diseased cells, in a novel rechallenge assay using peripheral blood mononuclear cells from an unmatched SLE donor. FT522 uniquely drove rapid and deep depletion of CD19-positive donor B cells, eliminated alloreactive donor T-cells, and maintained Functional Persistence, with the ability to kill additional CD19- In addition, we also presented initial translational data from the first two patients treated in our ongoing phase one study of FT522 in relapsed refractory B-cell lymphoma.

Scott Walshco: Today at the <unk> annual meeting, we reported preclinical data using <unk> diseased cells.

Scott Walshco: In a novel re challenge assay using peripheral blood mononuclear cells from an unmatched SLE donor.

Scott Walshco: <unk> uniquely drove rapid and deep depletion of CD 19 positive donor b cells are eliminated allo reactive donor T cells and maintained functional persistence with the ability to kill additional.

Scott Walshco: <unk> CV 19 positive donor b cells upon re challenge.

Scott Walshco: In addition, we also presented initial translational data from the first two patients treated in our ongoing phase one study of FG 522 in relapsed refractory b cell lymphoma.

Scott Walshco: These data show enhanced persistence of 522 in the periphery, compared to clinical data observed with FT-596, a prior-generation CD19-targeted CAR and K-cell without ADR technology. Importantly, these data also show rapid, deep, and sustained B-cell depletion in the periphery throughout the one-month treatment cycle. We intend to submit an IMD application to the FDA in the middle of 2024 to expand our clinical investigation of FD522 for treatment of various B-cell mediated autoimmune diseases, including without the administration of conditioning chemotherapy to patients.

Scott Walshco: These data show enhanced persistence of $5 two two in the periphery.

Scott Walshco: <unk> two clinical data observed with Ft 596, our prior generation CD 19 targeted car NK cell without ADR technology.

Scott Walshco: Importantly, these data also show rapid deep and sustained b cell depletion in the periphery throughout the one month treatment cycle.

Scott Walshco: We intend to submit an IND application to the FDA in the middle of 2024 to expand our clinical investigation of <unk> to two for treatment of various b cell mediated autoimmune diseases, including without administration of conditioning chemotherapy.

Scott Walshco: <unk> to patients.

Scott Walshco: I'm also pleased to report that the first three patients in the conditioning arm of our Phase 1 study of FT5224 for relapsed refractory B-cell lymphoma have now completed safety assessment without any dose-limiting toxicity, and there were no events of any grade of CRS, ICANNs, or GVHD.

Scott Walshco: I'm also pleased to report that the first three patients in the conditioning arm of our phase one study of Ft 502 for relapsed refractory B cell lymphoma have now completed safety assessment without any dose limiting toxicities and there were no events of any grade.

Scott Walshco: Up Crs I cans or gvhd.

Scott Walshco: Dose escalation is now ongoing at 900 million cells per dose. In addition, patient enrollment has now been initiated in the no-conditioning arm at 300 million cells per dose. And we are poised to clinically assess the safety and activity of our ADR-armed FT522 CAR and K-Cell program without the administration of conditioning chemotherapy. Turning to our solid tumor initiatives, I'm also pleased to announce that, in collaboration with Ono Pharmaceutical, we recently treated the first patient in our phase one study of FT825.

Scott Walshco: Dose escalation is now ongoing at 900 million cells per dose.

Scott Walshco: In addition, patient enrollment has now been initiated in the no conditioning arm at 300 million cells per dose.

Scott Walshco: And we are poised to clinically assess the safety and activity of our ADR armed ft. Five two car NK cell program without administration of conditioning chemotherapy to patients.

Scott Walshco: Designed using the company's iPSC product platform, we believe FTA-25 represents an exciting new frontier in the field of cell-based cancer immunotherapy. The multiplex-engineered, IPS-derived CAR T-cell program incorporates a constellation of synthetic anti-tumor mechanisms, that are designed to harness the potential of both innate and adaptive immunity, and to overcome unique challenges in treating solitude. These mechanisms include a CXCR2 receptor to promote cell trafficking, a chimeric TGF-beta receptor to redirect immunosuppressive signals in the tumor microenvironment, a high-affinity, non-cleavable CD16A receptor to promote antibody-dependent cellular cytotoxicity, and a novel cancer-specific HER2-targeted antigen binding donor, which has shown differentiated activity from that of trastuzumab in preclinical studies, including against HER2 low-expressing tumors.

Scott Walshco: Designed using the company's Ips C product platform, we believe the FTA two five represents an exciting new frontier in the field of cell based cancer immunotherapy.

Scott Walshco: But multiplexed engineered Ips derived car T cell program incorporates a constellation of synthetic anti tumor mechanisms that are designed to harness the potential of both innate and adaptive immunity and.

Scott Walshco: And to overcome unique challenges in treating solid tumors.

Scott Walshco: These mechanisms include a CX <unk> two receptor to promote cell trafficking.

Scott Walshco: Chimeric TGF beta receptor to redirect immuno suppressive signals in the tumor microenvironment.

Scott Walshco: High affinity non cleavable <unk> receptor to promote antibody dependent cellular cytotoxicity cytotoxicity.

Scott Walshco: And a novel cancer specific her two targeted antigen binding domains.

Scott Walshco: Which has shown differentiated activity from that of Trastuzumab in preclinical studies, including against her two low expressing tumor cells.

Scott Walshco: The first patient in the Phase 1 study was diagnosed with HER2 positive gastroesophageal junction adenocarcinoma, had progressed after receiving multiple lines of treatment, including HER2-targeted therapy, and was administered standard conditioning chemotherapy, followed by a single dose of FTA-2-5 as monotherapy at 100 million cells. As we consider our strategic direction, we believe there is a strong value proposition for our IPFC product platform and off-the-shelf cell therapies in autoimmunity where patient safety, convenience, and accessibility, as well as cost and scale, may be key differentiating factors.

Scott Walshco: The first patient in the phase one study was diagnosed with her two positive gastroesophageal junction Dino carcinoma had.

Scott Walshco: Had progressed after receiving multiple lines of treatment, including her to targeted therapies.

Scott Walshco: <unk> was administered standard conditioning chemotherapy, followed by a single dose of <unk> five as monotherapy at 100 million cells.

Scott Walshco: As we consider our strategic direction. We believe there is a strong value proposition for our <unk> product platform and off the shelf cell therapies and auto immunity.

Scott Walshco: Patient safety convenience and accessibility as well as cost and scale.

Scott Walshco: Key differentiating factors.

Scott Walshco: We believe our ADR technology can enable effective treatment with cell therapy without requiring the administration of conditioning chemotherapy to patients, which has the potential to redefine the cell therapy treatment paradigm and patient experience for cancer and autoimmunity. And we believe our multiplexed-engineered, IPFC-derived CAR T-cell platform can deliver multiple synthetic mechanisms of anti-tumor activity, with the potential to overcome unique challenges in treating solid tumors.

Scott Walshco: We believe our ADR technology can enable effective treatment with cell therapy without requiring administration of conditioning chemotherapy to patients.

Scott Walshco: Each has the potential to redefine the cell therapy treatment paradigm and patient experience for cancer and autoimmunity.

Scott Walshco: And we believe our multiplexed engineered Ips derived car T cell platform can deliver multiple synthetic mechanisms of anti tumor activity with.

Scott Walshco: With the potential to overcome unique challenges in treating solid tumors.

Scott Walshco: As we look ahead into the second half of 2024, we are well-positioned to reach and report on five key clinical milestones across our IPFC product pipeline for cancer and autoimmune diseases. Number one, we seek to demonstrate the disease-transforming potential of FT-819 in B-cell mediated autoimmune disease. Specifically, we expect to read out initial Phase I clinical data for the first three to five patients treated with FT-819 for moderate to severe SLAs

Scott Walshco: As we look ahead into the second half of 2024, we are well positioned to reach and report on five key clinical milestones across our Ips C product pipeline for cancer and autoimmune diseases.

Scott Walshco: Number two, we seek to administer FT-819 without fluidarabine and instead with commonly used treatment regimens for autoimmune diseases. Specifically, we intend to amend the current IND for our FT-819 Phase I autoimmunity study to include administration with single-agent cytoxin and expect to read out initial patient clinical data. Number three, we seek to demonstrate the potential of our proprietary ADR technology to enable effective treatment of patients without the administration of conditioning chemotherapy. Specifically, we expect to read out the first five.

Scott Walshco: Number one we.

Scott Walshco: We seek to demonstrate the disease transforming potential other FTA 19 in b cell mediated autoimmune diseases.

Scott Walshco: Specifically, we expect to readout initial phase one clinical data for the first three to five patients treated with FCA 19 for moderate to severe SLE.

Scott Walshco: Number two we seek to administer FTA 19 without fludarabine.

Scott Walshco: And instead with commonly used treatment regimens for autoimmune diseases.

Scott Walshco: Specifically, we intend to amend the current IND for our FTA 19 phase one auto immunity study to.

Scott Walshco: To include administration with single agents I toxin.

Scott Walshco: And expect to readout initial patient clinical data.

Scott Walshco: Number three we seek to demonstrate the potential of our proprietary ADR technology to.

Scott Walshco: To enable effective treatment of patients without administration of conditioning chemotherapy.

Scott Walshco: Specifically, we expect to read out the first five no conditioning patients treated with <unk> <unk>, two and our phase one study for B cell lymphoma.

Scott Walshco: No conditioning patients were treated with 5-2-2 in our Phase I study for B-cell lymphoma. Number four, we seek to broadly investigate 522 without conditioning chemotherapy for treatment of various B-cell-mediated autoimmune diseases. Specifically, we expect to submit an IND application and, subject to IND allowance by the FDA, initiate patient enrollment in a Phase I multi-indication study of 522 for autoimmunity. And finally, we seek to establish initial clinical proof of concept for our multiplexed engineered IPS-derived CAR T cell platform in treating solid tumors.

Scott Walshco: Number four we seek to broadly investigate five two without conditioning chemotherapy for treatment of various b cell mediated autoimmune diseases.

Scott Walshco: Specifically, we expect to submit an IND application and subject to the IMD allowance by the FDA.

Scott Walshco: Initiate patient enrollment in our phase one multi indication study of $5 two two for autoimmunity.

Scott Walshco: And finally, we seek to establish a new to show clinical proof of concept for our multiplexed engineered Ips derived car T cell platform in treating solid tumors spa.

Scott Walshco: Specifically, we expect to read out the first 3-5 patients treated with FTA-25 in our Phase 1 Study for Advanced Solid Tumors. I would now like to turn the call over to Ed to review our financial results for the first quarter.

Scott Walshco: Specifically, we expect to read out the first three years to five patients treated with FTA, two five and our phase one study for advanced solid tumors.

Scott Walshco: I would now like to turn the call over to Ed to review our financial results for the first quarter.

Edward J. Dulac: Thank you, Scott, and good afternoon. Fate Therapeutics is in a strong financial position to advance our pipeline of IPSC-derived CAR-T and CAR-NK cell programs for autoimmune diseases and cancer. With the addition of net proceeds from the company's $80 million underwritten offering of common stock and $20 million concurrent private placement of pre-funded warrants in March, our cash, cash equivalents, and investments at the end of the first quarter were approximately $391 million.

Ed: Thank you Scott and good afternoon.

Edward J. Dulac: Fate Therapeutics is in a strong financial position to advance our pipeline of high PSC derived car T and car NK cell programs for autoimmune diseases and cancer.

Edward J. Dulac: Yeah.

Edward J. Dulac: In the first quarter, our reported revenue of $1.9 million was consistent with the prior two quarters and reflects research funding associated with the development of a second product candidate against an undisclosed target in solid tumors under our collaboration with Ono Pharmaceuticals. As a reminder, after opting into a U.S. and European co-development and co-commercialization arrangement with ONO for FT825 in the fourth quarter of 2022, we account for that program's reimbursable expenses as an offset within our research and development costs.

Edward J. Dulac: In the first quarter, our reported revenue of $1 9 million was.

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

Edward J. Dulac: We recognized $800,000 of Contra R&D expense in the quarter. Research and development expenses for the first quarter were $32.1 million, essentially flat versus the fourth quarter of last year. Our expenditures on R&D were driven primarily by salaries and benefits, including share-based compensation, and from clinical trial costs and demand for R&D materials. General and administrative expenses for the first quarter increased sequentially by 16% to $20.9 million.

Edward J. Dulac: We recognized $800000 of Contra R&D expense in the quarter.

Edward J. Dulac: Research and development expenses for the first quarter were $32 $1 million essentially flat versus the fourth quarter of last year.

Edward J. Dulac: Our expenditures in R&D were driven primarily by salaries and benefits, including share based compensation and from clinical trial costs and demand for R&D materials.

Edward J. Dulac: General and administrative expenses for the first quarter increased sequentially by 16% to $20 9 million.

Edward J. Dulac: The increase in our G&A expenses was attributable primarily to increases in legal related fees.

Edward J. Dulac: The increase in our G&A expenses was attributable primarily to increases in legal-related fees. Total operating expenses for the first quarter increased by 7% relative to the fourth quarter of 2023 to $53 million, which included $11 million in non-cash, share-based compensation expense. Note that in connection with the development of our off-the-shelf IPFC-derived CAR T-cell product candidate, FT-819, we previously achieved the clinical milestone set forth in our amended license agreement with Memorial Sloan Kettering Cancer Center, which triggered a first milestone payment to MSK in 2021.

Edward J. Dulac: Total operating expenses for the first quarter increased by 7% relative to the fourth quarter of 2023 to <unk> $53 million, which included $11 million and noncash share based compensation expense.

Edward J. Dulac: Note that in connection with the development of our off the shelf Ips derived car T cell product candidate FTA 19, we previously achieved to clinical milestone set forth in our amended license agreement with Memorial Sloan Kettering Cancer Center, which.

Edward J. Dulac: Which triggered a first milestone payment to <unk> in 2021.

Edward J. Dulac: 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 $2.7 million, on a quarterly basis. In the first quarter, we recorded a non-cash, $1.4 million non-operating loss associated with the change in fare value. Our net loss for the quarter was $48 million, or 47 cents per share.

Edward J. Dulac: Up to two additional milestone payments may be owed to <unk> based on subsequent trading values of the company's common stock ranging from 100 to $150 per share.

Edward J. Dulac: We assessed the fair value of these contingent milestone payments currently valued at $2 7 million on a quarterly basis.

Edward J. Dulac: In the first quarter, we recorded a noncash $1 4 million non operating loss associated with the change in fair value.

Edward J. Dulac: Our net loss for the quarter was $48 million or <unk> 47 per share.

Edward J. Dulac: Finally, as we consider the investments we plan to make this year, we expect our GAP operating expenses, which includes non-cash items such as stock compensation expense and depreciation, for the full year to be between $215 and $230 million, and that we will end the year with more than $270 million in cash. Cash Equivalents and Investments. I would now like to open the call for questions. We will now begin the question and answer session. To ask, you may press the star then 1 on your touch screen.

Edward J. Dulac: Finally, as we consider the investments we plan to make this year, we expect our GAAP operating expenses.

Edward J. Dulac: Which includes noncash items, such as stock compensation expense and depreciation for the full year to be between 215 and $230 million.

Edward J. Dulac: And that we will end the year with more than $270 million in cash and cash equivalents and investments.

Edward J. Dulac: I would now like to open the call for questions.

Edward J. Dulac: We will now begin the question and answer session to ask a question you May Press Star then one on your Touchtone phone if youre using a speakerphone. Please pick up your handset before pressing the keys.

Operator: If you are using a speakerphone, please pick up your handset before pressing the button. If at any time your question has been addressed, I would like to withdraw it, Prastar. At this time, we will pause momentarily to assemble our... What was your first question? Michael Yee with Jeffrey's, please go ahead.

Speaker Change: If at any time. Your question has been addressed and you would like to withdraw. Your question. Please press Star then two at this time, we will pause momentarily to assemble our roster.

Michael Jonathan Yee: The first question comes from Michael <unk> with Jefferies. Please go ahead.

Michael Jonathan Yee: Thank you we had a two part question congrats on all the progress Scott Paul on the autoimmune study that is enrolling I know that was a bit slow to get off but it sounds like youre going to have some good momentum in report patient can you just talk a little bit about how the plan to also allow us single agents I toxin.

Michael Jonathan Yee: What impact teams and how you think about what that would show and how that would impact the design of the study and then the second question is related to <unk> I think it's exciting youre now in the second cohort without an input depletion can you just talk about the results that you might see there and how you would read through into what you see there into the idea for auto.

Scott Walshco: Immune as well thank you.

Scott Walshco: Sure, so in the autoimmunity study with FD-819, the current study as designed has two different alternatives for conditioning. There is a standard three-day conditioning cycle of PsyFlu, which is commonly used in the oncology setting. So I believe it's 500 milligrams per meter squared times three days for cyclophosisphamide and 30 milligrams per meter squared times three days for fluid aerobin.

Scott Walshco: Sure so with auto in the autoimmune and he started with FCA to 19.

Scott Walshco: The current study as designed.

Scott Walshco: <unk> has two different alternatives for conditioning.

Scott Walshco: Times three days.

Scott Walshco: Fludarabine.

Scott Walshco: In the current study, we also have a second conditioning regimen that is permitted. The second conditioning regimen is a bendamustine-based conditioning regimen. And that is a two-day treatment regimen with Bend the Muscle. Well, we're contemplating doing this, and this is based on data we presented today. We believe we have good proof of concept in our FT-819 oncology study, so this is the study in cell malignancies where several of our patients in that study received Fendomus as a conditioning agent.

Scott Walshco: We also have a second in the current study. We also had a second conditioning regimen that is permitted the second conditioning regimen is bendamustine based conditioning regimen.

Scott Walshco: And that is that shoe day treatment regimen with Bendamustine.

Scott Walshco: While contemplating doing and this is based on data we presented today.

Scott Walshco: We believe we have good proof of concept.

Scott Walshco: In our FCA 19 oncology study.

Scott Walshco: So these this is this study in B cell malignancies.

Scott Walshco: Where several of our patients in that study received bendamustine as a conditioning agents that they did not receive side flow. They received have been debased conditioning regimen.

Scott Walshco: So they did not receive CyFlo. Instead, they received a Benda-based conditioning regimen in the oncology study. We presented the data on those patients specifically today. We saw very deep B-cell depletion in the periphery, which was maintained through the 30-day treatment cycle. And importantly, we saw a clinical response with the Bend and Musteem Treatment, conditioning cycle or conditioning regimen. So we did not use fludabar, and in that regimen, we're not using fludarabine.

Scott Walshco: <unk> oncology study.

Scott Walshco: We presented the data on those patients specifically today, we saw very deep b cell depletion.

Scott Walshco: In the periphery, which was maintained through the 30 day treatment cycle and importantly, we saw clinical responses.

Scott Walshco: With the Bendamustine treatment.

Scott Walshco: Conditioning cycle or conditioning regimen.

Scott Walshco: So we did not use <unk>, so with that regimen, we're not using fludarabine.

Scott Walshco: So we saw activity with FT-819 without fluidarabin, and that gives us confidence that we can amend the IND to add on to a Cytoxan-only regimen. We believe we can accomplish that efficiently through an amendment to the IND, essentially adding a third, quote-unquote, conditioning regimen for patients. And so the study would provide physicians with their choice of PSY flu conditioning rather than the mustine conditioning or single-agent cytoxan condition. And again, since Cytoxan and Bust-Bendamustine are in the same class of molecule, and given the activity we've seen in the oncology study, we feel confident in FT-819's ability to perform in a Cytoxan-only regimen without Fluderic. A long answer, but I hope that was clear. Yeah, it's very nice.

Scott Walshco: So we saw activity with FTA 19 without Fludarabine.

Scott Walshco: And so that gives us confidence that we can amend the IMD.

Scott Walshco: To add on to a site toxin only regimen. We believe we can accomplish that efficiently through a amendment to the IMD.

Scott Walshco: Essentially adding a third quote unquote conditioning regimen.

Scott Walshco: For patients.

Scott Walshco: And so the study will provide physicians choice of Psi fluid conditioning.

Scott Walshco: Bendamustine conditioning or single agents site toxin conditioning.

Scott Walshco: This site toxin only regimen without the Derrick.

Scott Walshco: Long answer, but I hope that was clear.

Scott Walshco: And then the read through from oncology because you are in the cohort D without.

Scott Walshco: Conditioning.

Scott Walshco: Yeah, so with respect to $5 two two.

Scott Walshco: So we're thoughtful with $5. Two obviously, we have a long history with NK cells. We have started the study with psi fluid conditioning.

Scott Walshco: It provides us the opportunity to do some direct comparison with $5. Two two based on historical datasets that we have generated with ft 596, our prior generation product.

Scott Walshco: We presented data today where we believe in early small numbers of patients, obviously. We think we're seeing some differentiated activity with respect to persistence, which we're excited about. And so, we are very excited now to... essentially begin our clinical experiment with 5-2-2 or clinical experience with 5-2-2 with no conditioning.

Scott Walshco: And so we are very excited now too.

Scott Walshco: Essentially the DNR clinical experiment.

Scott Walshco: With $5 two to her clinical experience with $5 two with no conditioning.

Bahram Valamehr: Preclinically, and I'll let Bob talk about it, we've done a tremendous amount of work with 522 preclinically in our genetic system, both using cancer cell lines as well as now using donor SLE cells. And we presented the donor SLE preclinical data today. I'll let Bob talk about that because I think it does demonstrate the potential of 522 to essentially thrive in an allogeneic disease. Thanks, Scott.

Scott Walshco: Pre clinically and I'll, let Bob talk about it we've done a tremendous amount of work with $5 two two pre clinically in our G&A access systems.

Bahram Valamehr: Both using cancer cell lines as well as now using donor cell cells and we presented the donor cell lead preclinical data today I'll, let Bob talk about that because I think it does demonstrate the potential of five Q2 to.

Bahram Valamehr: <unk>.

Bob: Rise in an allogeneic disease system.

Bahram Valamehr: So just to talk about preclinical and also answer some of your questions about how the clinical data will play out for autoimmune. So in preclinical, as Scott mentioned, having the ADR technology in 5-2-2 allows us to actually show activity and persistence even when there is an intact PBMC compartment. So in a Petri dish, we try to mimic what's happening in the patient setting by having the PBMCs, and there are all different types of cells from PBMCs, and we showed that with 5-2-2, you can actually show functional persistence, and this is very unique to the ADR technology because if you have NK cells without ADR or autologous CAR-T, you won't get this observation.

Bob: Thanks, Scott So just to talk about preclinical and also answer some of your questions about how the.

Bahram Valamehr: The clinical data will play out for autoimmune so in the pre clinically as Scott mentioned, having to ADR technology, and <unk> allows us to actually show activity and persistence.

Bahram Valamehr: When there is a PVA and tech pbms compartment. So in a petri dish, we try to mimic what's happening in that patient setting by having the <unk> and theyre all different types of cells from <unk> and we showed that with <unk> you can actually show functional persistence and and this is very unique to the <unk>.

Bahram Valamehr: Technology, because if you have.

Bahram Valamehr: NK cells without ADR or autologous car T. You won't give this observation in this observation is very specific because we can co culture at <unk> with <unk>.

Bahram Valamehr: And this observation is very specific because we can co-culture 522 with PBMC and show that we can target, because there's a CAR-19 in 522, the B cells in PBMC. However, we don't see an alloreaction that's induced by the T cell compartment. Even though these cells have an intact HLA expression on their surface, our product, we are able to hold off the alloreaction because we target the form B positive population, which is the final stage of an activated cell. So we are able to hold off on that.

Bahram Valamehr: And show that we can target because the car 19, 5%.

Bahram Valamehr: <unk>. However, we don't see in our reaction that's induced by the T cell compartment, even though these cells have an intact HLA expression on the surface. Our product we are able to hold off to our reaction because we target from the positive.

Bahram Valamehr: And we can maintain activity through functional persistence because when we re-challenge the 522 co-culture with additional PBMC, we can continue targeting the B cell compartment and maintain functional persistence. This is not seen with autocar T. This is not seen with any K cell. Moving to the clinical experience, I think one of the things that we're very excited about with our ability to translate on the 5-2-2, no, 5-flu arm, we're going to be able to look at ctDNA and see how the disease is modulated with each dose of 5-2-2 in an intact patient immune compartment and also look at the entire disease decrease over the treatment cycle.

Bahram Valamehr: The $5 two two co culture with additional <unk>, we can't continue targeting the T cell compartment and maintain functional persistence. This is not seen with Autocar T. This is not seen with NK cell.

Bahram Valamehr: Moving to the clinical experience I think one of the things that we're very excited about with the with our ability translational under $5 to the site to arm.

Bahram Valamehr: That's going to give us a hint of 5-2-2 activity without 5-flu conditioning. We'll also look at the endogenous immune compartment and see how that's modulated, and also look at the PK in an intact immune compartment with very sensitive assays. So we'll hopefully see a lot of activity there and be able to parlay that into an autoimmune disease. Yes. Perfect. Thank you, guys. Thanks. The next question... Yigal Nochomovitz, please go ahead. Hi, Tim. This is Amin Ansari Yigal. Thank you for taking our questions. We had a couple.

Speaker Change: Going to be able to look at Cte DNA.

Speaker Change: And see how the disease is modulator with each dose of <unk> and an intact.

Speaker Change: And Ian compartment and also look at the entire disease.

Speaker Change: Decrease over the treatment cycle, that's going to give us a hint of 5% to activity without by fleet conditioning. We'll also look at the endogenous immune compartment and see how that modulate it and also look at the PK and an intact immune component with very sensitive assay. So we'll hopefully see a lot of activity there and Diego.

Speaker Change: To parlay that into autoimmune disease.

Speaker Change: Yes, perfect. Thank you guys.

Bahram Valamehr: Thanks.

Yigal Dov Nochomovitz: The next question comes from Yigal <unk> with Citi. Please go ahead.

Amin Ansari: Hi, Tim this is on for Yigal. Thank you for taking our questions you had a couple first on FTE.

Yigal Dov Nochomovitz: First, on FT819, you mentioned patient case studies showing secondary and tertiary tissue trafficking and infiltration. Are you doing tissue biopsies here? Sure. So we do show primary, secondary, and tertiary activity. For the primary, we show that we have persistence in the bone marrow, and that correlates with reduction and elimination of CLL-positive cells.

Speaker Change: <unk> emission patient cases studies have shown.

Yigal Dov Nochomovitz: I've shown secondary and tertiary tissue trafficking infiltration.

Speaker Change: Are you doing tissue biopsy here.

Yigal Dov Nochomovitz: Sure.

Yigal Dov Nochomovitz: So we do show a primary secondary and tertiary activity for the primary we showed that we have.

Bahram Valamehr: And this is based on full cytometry. So we show persistence and infiltration in the bone marrow and clearance of the disease. In our secondary, for the lymphoid, we have biopsies of the lymphoid tissues, we have biopsies there, and we can show that the population is reduced. And for the tertiary, the example we used in our presentation was the liver and PET score, which correlates to PK. So we're able to, through different methods, whether it's direct detection of cells or proxy detection of cells, be able to show that we have activity in both primary, secondary, and tertiary tissues. Okay, great. That makes sense.

Bahram Valamehr: Persistence in the bone marrow and that correlates with reduction and elimination of CLO positive cells and this is based on flow cytometry. So we show.

Bahram Valamehr: Persistence and infiltration in the bone marrow and clearance of disease.

Bahram Valamehr: And our and our secondary for the for the lymphoid we have biopsy.

Bahram Valamehr: The lymphoid tissues, we have biopsies, there and we can show that the population is reduced and for tertiary. The example, we used in our presentation as liver and pets pet score, which correlates to PK. So we're able to through different methods, where there is direct detection of cell.

Bahram Valamehr: Or.

Bahram Valamehr: Proxy detection of cells to be able to show that we are able to have activity and with primary secondary and tertiary tissues.

Speaker Change: Okay, great that makes sense.

Speaker Change: The second question one of the General question given you are planning to file an IND for FQ2 to four <unk>.

Scott Walshco: And then the second question is more of a general question. Given your planning to file an IMD-IV FDA 5224 autoimmune, how should we think about the expectations for efficacy here? Are you hoping to see efficacy on par with CAR T's, or is it the main focus more like? Removing or lowering the preconditioning burden may be a little bit of a cost for efficacy.

Scott Walshco: How should we think about expectations on the efficacy here are you, hoping to see efficacy on par with car Ts or is it the main focuses more like.

Scott Walshco: Removing or lowering the precondition embedded.

Scott Walshco: Maybe.

Scott Walshco: So it will be because of costs on efficacy.

Scott Walshco: Yeah, I think as we're going into this study, we acknowledge that because it's really important. I think at the end of the day, what's really exciting about cell therapy here in autoimmunity is the fact that, again, this is coming out of a German study. A single dose of CAR T-cell therapy has been able to generate an immune reset in patients that have had the disease and refractory disease for a significant period of time. And that's been quite remarkable, and I think folks are very excited about that.

Speaker Change: Yes, I think as we're going into this study we acknowledge up because he is really important I think at the end of the day, what's been really exciting about cell therapy here in autoimmunity is the fact that again.

Scott Walshco: Coming out of the German study.

Scott Walshco: Yes.

Scott Walshco: A single dose of car T cell therapy has been able to generate an immune reset in patients that have had have had disease in refractory disease for a significant period of time.

Scott Walshco: And that's been quite remarkable and I think folks were very excited about that and I think.

Scott Walshco: And I think, with respect to autoimmunity, efficacy is certainly going to be important, and we need to acknowledge that, at some basic level, we need to be able to compete on efficacy. Autoimmunity is a very different setting than oncology, and I think safety is certainly going to be at a premium with respect to autoimmunity. I think one of the challenges that have already confronted the field is that side fluid conditioning may not be well accepted by patients in the field of autoimmunity. And so I think safety is going to be critical.

Scott Walshco: With respect to autoimmunity efficacy is certainly going to be important and we need to acknowledge that at some basic level, we need to be able to compete on efficacy that said.

Scott Walshco: Auto immunity is a very different setting that oncology.

Scott Walshco: And I think safety is certainly going to be at a premium.

Scott Walshco: With respect to autoimmunity.

Scott Walshco: I think one of the challenges that has already confronted the field is that psi fluid conditioning.

Scott Walshco: Not be well accepted by patients in the field of autoimmunity and so I think safety is going to be critical I think alternative regimens, where you can add on to standard of care treatments is going to be critical I think reaching patients where they live and breathe, which is not at the academic car T cell centers.

Scott Walshco: I think alternative regimens where you can add on to standard of care treatments are going to be critical. I think reaching patients where they live and breathe, which is not at the academic CAR T cell centers, is going to be critical. And so I think there are a multitude of elements here that are going to be important in autoimmunity that are different than in oncology. And I do think an off-the-shelf cell therapy has a significant sort of a... Attributes that can be very appealing for these people.

Scott Walshco: He is going to be critical.

Scott Walshco: And so I think there are a multitude of elements here that.

Scott Walshco: That are going to be important in autoimmunity that are different than oncology and I do think it off the shelf cell therapy has significant sort of.

Scott Walshco: Attributes that Ken.

Scott Walshco: Very appealing for these patients.

Speaker Change: Okay got it great. Thank you very much for taking our questions.

Scott Walshco: The next question comes from Diana <unk> with Leerink partners. Please go ahead.

Daina Michelle Graybosch: Okay, got it. Great. Daina Graybosch with Leering Partners.

Scott Walshco: Please go ahead. All right, so this is Jeff on for... So we have two questions, and the first was about the competitive landscape.

Daina Michelle Graybosch: So this is Jeff on for Dana.

Daina Michelle Graybosch: So we have got two.

Daina Michelle Graybosch: Two questions. The first was.

Daina Michelle Graybosch: Around competitive landscape. There are some recently published encouraging data with the firsthand in 2019.

Scott Walshco: There were some recently published encouraging data with the first gen CD19 by Blenatumamab. What was your view of that data, and how are you thinking about it? T-cell engager competition overall for autoimmune disease, given that the modality addresses as many of the same challenges of AutoCard T that your off-the-shelf programs do. And then looking at BCMA and your plans for a next-gen program there. Do you expect to use the ADR modality there, and is that sufficient, or are you looking at other edits, and what do you think BC may add that you wouldn't already achieve with your CD19 program?

Scott Walshco: <unk> when it came to Nab bullish review that data and how you're thinking about <unk>.

Scott Walshco: Some gauge of competition overall for autoimmune disease, given that the modality.

Scott Walshco: The addresses many of the same challenges of auto car T that you are off the shelf program soon and then looking at kind of <unk> and your plans for our next Gen program there.

Scott Walshco: Do you expect to use the ADR modality, there and is that sufficient or are you looking at.

Scott Walshco: And what do you think do you see may add that you wouldn't already achieved but your CD 19 program. Thank you.

Scott Walshco: Thank you. Yeah, so on your sort of general question around CD19 engagers, I think we're approaching the autoimmunity space with eyes wide open with respect to the disruptive potential of CD19 engagers.

Scott Walshco: Yes, so on your sort of general question around CD 19.

Scott Walshco: <unk>.

Scott Walshco: I think we're approaching the autoimmunity space.

Scott Walshco: Eyes wide open with respect to the disruptive potential of CD 19, <unk> and ultimately as we're thinking about the development of the autoimmune space.

Scott Walshco: And ultimately, as we think about the development of the autoimmunity space, we recognize the benefits that can be brought to patients potentially through the differentiating potential of the CD19 engager. We've obviously seen that play out in oncology. And as we think about it, we're thinking about essentially our target product profile.

Scott Walshco: Recognize.

Scott Walshco: The benefits that can be brought to patients potentially in differentiating potential of CD 19, gauger, we've obviously seen that play out in oncology.

Scott Walshco: And as we think about it we were thinking about essentially our target product profile.

Scott Walshco: Going directly up against.

Scott Walshco: I'm going directly to the value proposition of a T-cell engager, and hence that's how you will hear us obviously talk about, and we talked about on the call today, how important we think it is to move away from side effects, to add on to standard of care treatments, to reach patients in the community setting, to minimize hospitalization, and to prioritize safety and efficacy. So I think we're going into this recognizing that T cell engagers will play an important role in treating patients with autoimmunity and developing target product profiles directly head-to-head again.

Scott Walshco: What the value proposition of the T cell engagement and <unk>.

Scott Walshco: That's how you will hear us obviously talk about and we've talked about on the call today, how important we think it is to move away from Cy flew to add on to standard of care treatments to reach patients in the community setting to minimize hospitalization.

Scott Walshco: And to prioritize.

Scott Walshco: Safety and efficacy. So I think we're going into this recognizing that T cell engages will play an important role in treating patients with autoimmune and developing target product profiles directly head to head against them.

Scott Walshco: As it relates to BCMA, I think just generally, and this is not a comment specifically to BCMA, but I think we're very excited about the ADR technology, both with respect to its first assessment with 522 clinically, but I think, And I'll let Bob talk about it, and correct me if I'm wrong, but I think any product candidate you're gonna see emerge from Fate Therapeutics from this point forward will incorporate We absolutely believe that Conditioning Chemotherapy, or intense conditioning Chemotherapy, is, um.., a headwind for the field of cell therapy, and we need to move beyond that. And we're excited to do that!

Scott Walshco: We absolutely believe that.

Scott Walshco: Conditioning chemotherapy intense chemotherapy conditioning chemotherapy is.

Scott Walshco: A headwind for the field of cell therapy, and we need to move beyond that.

Scott Walshco: We're excited to pioneer that, and we think we've put a tremendous amount of work, both with respect to research and innovation, on how to achieve a new cell therapy treatment paradigm with off the shelf. Great. Thank you. Um, actually just a quick, a quick follow-up in mitigating lymph depletion. Uh, how does Bend and Mustine only compare to cyclophosisphamide only in terms of relative potency? And would you expect the same degree of, you know, CAR T, FTE 819 expansion in vivo and the same level of potency as you kind of saw with the Benden-Mustaine examples?

Scott Walshco: With off the shelf cell phone.

Speaker Change: Great. Thank you.

Scott Walshco: Actually just a quick quick follow up and the mitigating LIFO depletion.

Scott Walshco: Bendamustine only compare to cyclophosphamide only in terms of relative potency.

Scott Walshco: And would you expect the same degree of.

Scott Walshco: Car T. SD 809 expansion in vivo in the same level of potency as you kind of saw with Bendamustine examples.

Scott Walshco: Yeah, I think it's... There's some data on this, right? There's some data out there that certainly combine in the field of oncology and CAR-T cell therapy that has done work. Comparing Thigh Flu Conditioning to Ben DeMoss. And I think, generally speaking, it's been demonstrated that bendamustine can be an effective alternative treatment conditioning regimen for CAR T cell therapy. Bendamustine is in the same chemical class as cyclophosisphamide.

Speaker Change: Yes, I think.

Scott Walshco: It is.

Scott Walshco: <unk>.

Scott Walshco: There is some data on that right. There is some data out there that certainly combines in the field of oncology and car T cell therapy that has done.

Scott Walshco: Work.

Scott Walshco: Comparing.

Scott Walshco: Flu conditioning.

Scott Walshco: Two bendamustine.

Scott Walshco: And I think generally speaking.

Scott Walshco: Being demonstrated that Bendamustine hendi.

Scott Walshco: <unk> alternative treatment conditioning regimen.

Scott Walshco: For car T cell therapy.

Scott Walshco: Bendamustine is in the same chemical class as cyclophosphamide.

Michael Eric Ulz: We do have experience, as I mentioned, with Bendamustine as a stand-alone conditioning agent without flu therapy, and so we're fairly confident that our programs, FJ-819, can perform with cyclophosisphamide. Great, thanks for taking our questions. The next question comes from Mike Ulz with Morgan Stanley. Please go ahead. Hi, this is Rohit on behalf of MedImmune. Thank you for taking our questions

Scott Walshco: We do have experience as I mentioned with Bendamustine as a stand alone conditioning agent without fludarabine.

Rohit: And so we're fairly confident.

Michael Eric Ulz: <unk>.

Rohit: Programs can <unk> can perform with cyclophosphamide.

Rohit: Great. Thanks for taking my questions.

Rohit: The next question comes from Michael <unk> with Morgan Stanley. Please go ahead.

Rohit: Hi, This is Robert on for Mike. Thanks for taking our questions can you just talk about what you've seen with the first lupus patients treated with <unk> hundred nine and.

Scott Walshco: Can you just talk about what you... the first lupus patient treated with FT-819, and how safety compares to what's been seen in the autologous ED-19 therapies, and then can you also talk about what other autoimmune diseases you would consider expanding to? Yeah, I think I'll limit my comments to what we have disclosed to date. The patient is still in the first participation phase, so it is still in the 30 day DLT assessment window. I can absolutely say that the patient was discharged after three days of hospitalization. So it was a three-day hospital stay. It was uneventful, and there were no notable adverse events.

Scott Walshco: And how safety compares to what's been seen in the autologous <unk> thousand 19 therapies.

Scott Walshco: And then can you also talk about what other auto immune diseases diseases, you would consider expanding too.

Speaker Change: Yes, I think I'll limit my comments to what we disclosed to date the patient is still in the first lease this patient.

Scott Walshco: Still is in the <unk>.

Scott Walshco: 30 day DLT assessment window.

Scott Walshco: Absolutely say that patience.

Scott Walshco: Was discharged after three days of hospitalization. So it was a three day hospitalization stay it was an eventful and there were no notable adverse events.

Scott Walshco: The patient does still remain though in the 30 day DLT assessment point, though.

Scott Walshco: The patient does still remain, though, in the 30-day DLT assessment. With respect to expansion and other indications in autoimmunity, you know, we are doing a fair bit of work assessing that opportunity. Obviously, one of the elements of assessment is looking where others have established themselves.

Scott Walshco: With respect to expansion into other indications in autoimmunity.

Scott Walshco: We are doing.

Scott Walshco: A fair bit of work assessing that opportunity obviously one of the <unk>.

Scott Walshco: Elements of assessment is looking.

Scott Walshco: Others have established and this is primarily coming out of the German study, but also the field of allogeneic stem cell transplant.

Scott Walshco: And this is primarily coming out of the German study, but also the field of allogeneic stem cell transplantation, looking at where there's been success with other B cell mediated diseases with either transplantation or from the German group in the early seminal data. I think I'll leave it at that. Thank you. The next question: Lee Watsik with Cantor Fitzgerald, please go ahead. Good afternoon.

Lee Watsik: Looking at where other b cell, there's been success with other b cell mediated diseases with either transplant or out of the German group.

Lee Watsik: The early.

Lee Watsik: Seminal datasets.

Lee Watsik: And I'll leave it at that.

Lee Watsik: Thank you.

Lee Watsik: The next question comes from Lee <unk> with Cantor Fitzgerald. Please go ahead.

Lee Watsik: Thanks for taking the questions. Let me just follow up on what other indications you might go into, and this is Spec 4-522. I know, Scott, you mentioned that you're looking at multiple autoimmune diseases. So just wondering, since it's quite crowded in the room today, what are other, you know, indications that you might be considering, such as RA? And how do you think about 522 fitting with 819 in terms of which patient, which types of patients to go after? Sure. At this point, you know, we are doing a lot of work. But I am not going to disclose our strategy at this point in time.

Lee Watsik: Hey, good afternoon, thanks for taking the question maybe.

Speaker Change: Maybe just follow up on one other indication.

Lee Watsik: Going into Q1.

Lee Watsik: Four two.

Lee Watsik: Findings from Danielle.

Speaker Change: Welcome Paul.

Speaker Change: So just wondering.

Lee Watsik: Quite crowded.

Lee Watsik: So just wondering what.

Lee Watsik: Sure.

Lee Watsik: You might be considering Morningstar, Inc.

Lee Watsik: Now how do you think.

Lee Watsik: Think about five two.

Lee Watsik: Okay.

Lee Watsik: <unk> nine <unk>.

Lee Watsik: <unk>, which patients.

Lee Watsik: Which types of patients to go after.

Lee Watsik: Sure at this point, we are doing a lot of work not going to disclose our strategy at this point in time, we are obviously doing a lot of work in thinking about our expansion strategy in autoimmunity.

Scott Walshco: We are looking at areas, where there have been clinical precedent with cell therapies, whether that be in transplant or out of the first data sets that are being generated.

Scott Walshco: Both out of Germany as well as.

Scott Walshco: The initial sort of company.

Scott Walshco: Okay.

Scott Walshco: And then maybe just wondering if you can just comment on your expectation for the patient enrollment.

Scott Walshco: One nine studies since like you.

Scott Walshco: You can dose the patient Sally quickly.

Scott Walshco: And then it seems like you are going to amend the protocol to allow some alternative conditioning regimen. So do you think that might drive that.

Scott Walshco: The traction with the site investigators.

Speaker Change: Yeah. So.

Scott Walshco: So specifically we have guided to three to five patient an update on three to five patients in the <unk> hundred 19 study.

Scott Walshco: By the end of this year, we've also guided to and we discuss it on the call that we are looking to.

Scott Walshco: Utilized by Thomson only as a third potential regimen for treating patients so XI flu than or bend.

Scott Walshco: <unk> only we.

Scott Walshco: We do think that, and I think there's been discussion about this, that CyFlu potentially is a barrier to treating patients with autoimmunity. These patients aren't oncology patients. They don't deserve to be treated like oncology patients.

Scott Walshco: We do think that.

Scott Walshco: And I think there's been discussion about this that Si flu potentially is a barrier to treating patients with autoimmune 80.

Scott Walshco: These patients arent oncology patients they don't deserve to be treated like oncology patients and so I do think moving away from Si fluids. The conditioning regimen is going to be critical to really capturing the potential of cell therapy in autoimmunity, and we look to pioneer that.

Greg: Thank you.

Greg: The next question comes from Tara Bancroft with TD Cowen. Please go ahead.

Scott Walshco: Hi, there. This is Greg speaking on behalf of <unk> Im wondering if you can give us any timeline for when we can expect clinical data in lupus for 2019.

Tara A. Bancroft: I'm wondering if you can give us any timeline for when we can expect clinical data in lupus for 899. Sure. In the prepared remarks, we guided to an update on the first three to five patients with FTA-19 in SLE by the end of this year. Okay, great. The next question comes from Ben Burnett with Stiefel. Please go ahead. Hi, this is Carolina Ibanez-Bentoso on behalf of

Carolina Ibanez: Sure in the prepared remarks, we've guided to an update on the first three to five patients with FCA 19 in SLE by the end of this year.

Speaker Change: Okay, great. Thank you.

Tara A. Bancroft: Sure.

Carolina Ibanez: The next question comes from Ben Burnett with Stifel. Please go ahead.

Carolina Ibanez: Hi. This is currently nine <unk> on for Ben Bernanke. Thank you for taking our question and Greg Congratulations on an ongoing progress.

Scott Walshco: Thank you for taking our question, and congratulations on all your progress. On the ex vivo data for FT819 on the pre-treatment sample from the SLE patient, what do the E.T. ratios mean?

Carolina Ibanez: On the ex vivo data.

Scott Walshco: Sure.

Carolina Ibanez: 1819 on Dave Friedman samples from from DSL lead patients.

Carolina Ibanez: Key ratios shown imply about beneficiary from sudden expansion. Thank you need to achieve to get that deep.

Ben Burnett: [inaudible] Visceral Depletion at the End of the Carves in Vivo, in the SLE. I'm happy to answer that question, and I'll use some math here, so please forgive me if I start getting a little hypothetical. So, what we show in the data is that at 2 to 1 ET ratio, we effectively eliminated all B cells that were in the PBMC compartment from the patient. If you were to think about the disease burden in autoimmune and specifically SLE, we anticipate somewhere around 100 to 300 million disease B cells residing within a patient.

Carolina Ibanez: B cell depletion at the end of the cars in in vivo in the SMA patients.

Speaker Change: I'm happy to answer that question and I'll use some math here. So please forgive me if I start getting a little hypothetical but.

Ben Burnett: What we show and the data is that at 201 <unk> ratio, we effectively eliminated all b cells that were in the <unk> compartment from the patient.

Ben Burnett: We are effectively clearing around.

Ben Burnett: Most all cells at two to one but pretty much over 95% at one to one hour.

Ben Burnett: Our current dose of $260 million falls right smack in the middle of an effective dose that we see in vitro. So.

Ben Burnett: To answer your question, specifically, we are eliminating all T cells at two to one and over 90% at one to one and that should give us confidence that the current dose.

Ben Burnett: It's basically on par to match that in the patient setting at $360 million.

Speaker Change: Okay great.

Speaker Change: Thank you.

Speaker Change: Good luck.

Ben Burnett: The next question comes from Peter Lawson with Barclays. Please go ahead.

Ben Burnett: So if we're effectively clearing around almost all cells at 2 to 1, but pretty much over 95% at 1 to 1, our current dose of 260 million falls right smack in the middle of an effective dose that we see in vitro. So to answer your question specifically, we're eliminating all B cells at 2 to 1 and over 90% at 1 to 1. And that should give us confidence that the current dose is basically on par to match that in the patient setting at 360 million. Pretty helpful. Thank you. The next question... This is Peter Lawson from Barclays. Please go ahead. Hi, this is Alex. I'm for Peter.

Ben Burnett: Hi, This is Alex on for Peter Thank you for taking the question just wondering if you could maybe just recap the data a little bit.

Peter Richard Lawson: Thank you for taking the question. Just wondering if you could cap the data a little bit, the ASGCT data when you're looking at... preclinical and translational data for 819. NK-Cell Program. Any notable differences you see in tissue distribution, or B-cell depletion. Sure, I can answer that question.

Alex: <unk> data when you look at the <unk>.

Alex: Preclinical and translational data for 809 versus $5 two so.

Alex: Our program.

Alex: Does the NK cell program.

Alex: Notable differences you see in terms of.

Alex: Tissue distribution, b cell depletion or b cell reconstitution.

Bahram Valamehr: So, FT-819 and FT-522 obviously are very different. FT-522 not only has the ADR technology but also has the IL-15 receptor fusion. So, preclinically, we see very good biodistribution with FT-522 because it very much doesn't need antigen for expansion and doesn't need cytokine for expansion. So, we see very good biodistribution. Obviously, it has the ability to be combined with a monoclonal antibody, and so we see that as well.

Alex: Sure I can answer that question.

Bahram Valamehr: <unk> hundred nine ft, 52, obviously, a very different ft 502 to not only has the ADR technology, but also have the IL 15 receptor fusion. So pre clinically we see as very good filed distribution with ft 500 to two because it's very much doesn't need antigen for expansion doesn't need cytokine for expansion.

Bahram Valamehr: Either we enhance activity against a specific cell, like, for example, targeting CD19 and CD20 at the same time, or going after other cell types that have eliminated the CD19 expression and are only expressing, for example, CD38. So, those are the main differences in terms of the behavior of these cells. We have a product that's ADR, that does not need conditioning, and can go multi-antigen targeting, and another product that's very potent against CD19.

Bahram Valamehr: So we see very good bio distribution, obviously it has the ability to become behind with the monoclonal antibody. So we see that as well either we enhance activity against the specific cell like for example, targeting CD 19, and CD 20 at the same time, we're going after other cell types that have eliminated the Citi 19 expression in our own.

Bahram Valamehr: Expressing for example, CD 38, so that multi antigen perspective also content through with ft five.

Bahram Valamehr: With Ft 819, having the one Xx car into Trac locus is very potent.

Bahram Valamehr: Car product and so we see that when we go head to head against auto car T. In preclinical studies, so we see very potent activity.

Bahram Valamehr: <unk> hundred nine as I mentioned earlier as well. So those are the main differences in terms of behavior of the cells we have.

Bahram Valamehr: The product Thats ADR that does any conditioning and can go multi antigen targeting and another product that's very potent against CD 19.

Bahram Valamehr: I think one of the comments I would just add to that is FT-819, with respect to its manufactured phenotype, has a high expression of CXCR4, and so we've seen very good homing and trafficking and infiltration of secondary and tertiary tissue in preclinical studies. Okay, thank you. And I guess does that have any implications for which type of Target, Indy Auto... Yeah, yeah. I mean, it's something we're looking at.

Bahram Valamehr: And I think one of the comments I would just add on to that is F 2019 with respect to what's manufactured phenotype has a high expression of <unk> four.

Bahram Valamehr: And so we've seen very good.

Bahram Valamehr: Homing in trafficking and infiltration of secondary and tertiary tissue in preclinical studies.

Speaker Change: Good point.

Bahram Valamehr: Okay. Thank you and I guess does that have.

Bahram Valamehr: Any applications for which type of indications you could target and the autoimmune autoimmune setting.

Scott Walshco: I mean, we are still doing work on thinking about exactly how to expand and what indications are going to be prioritized with 819 and 522. We are prepared, and we are preparing to expand the 819 IND to consider additional indications, and obviously, we've discussed filing a multi-indication IND for 522. So, a lot of work is going on. Stay tuned for that. The next question is Yanan Zhu with Wells Fargo Securities.

Speaker Change: Yeah Yeah.

Bahram Valamehr: It's something we're looking at I mean, we're still doing work on thinking about.

Yanan Zhu: Exactly how to expand and what indications are going to be prioritized within 19 and $5 two.

Scott Walshco: We are prepared and now we are preparing to expand the <unk> 19 IND.

Scott Walshco: To consider additional indications and obviously, we've discussed filing a multi indication.

Yanan Zhu: And for five years through two so a lot of work going on and stay tuned there on that front.

Yanan Zhu: The next question comes from your non Jew with Wells Fargo Securities. Please go ahead.

Yanan Zhu: Please go ahead. Great. Thanks for taking our questions. You know, to follow up on a prior question about the bi-specific literature, recent literature, just wondering, do you have an opinion on the depth of B-cell depletion a bi-specific antibody can achieve compared with cellular therapy? And, you know, do you foresee for the bi-spec, if it becomes a modality, would it be a repeat administration at a certain time interval? Could that be viable or competitive with cellular therapy?

Yanan Zhu: Great. Thanks for taking our questions.

Yanan Zhu: Following up on a prior question about the Bispecific literature recently for sure.

Yanan Zhu: Just wondering do you have a view on the depth of B cell depletion.

Yanan Zhu: Take antibody can achieve.

Yanan Zhu: Comparatively the cellular therapy and.

Yanan Zhu: Do you foresee for the bi spec if it becomes a modality would it be.

Yanan Zhu: Repeat administration at certain time interval.

Yanan Zhu: Could that be.

Yanan Zhu: No viable competitive with that of a therapy lastly, four eight.

Yanan Zhu: And lastly, for 819, do you foresee the, you know, potential possibility of additional doses at a certain time interval and whether that could be part of the product profile and whether you might even be considering looking at that in a current study? Sure.

Yanan Zhu: 809.

Yanan Zhu: Do you foresee.

Yanan Zhu: Potential possibility.

Yanan Zhu: Additional doses.

Yanan Zhu: At a certain time interval.

Yanan Zhu: And weather.

Yanan Zhu: That could be part of the product profile.

Yanan Zhu: You might even be considering looking at that current study. Thanks.

Speaker Change: Sure so.

Speaker Change: Forgive me I am not an expert.

Scott Walshco: The.

Scott Walshco: The T cell engages have generated complete responses.

Scott Walshco: Again, we are going into the field of autoimmunity, recognizing that T cell engages.

Scott Walshco: Ken DAA attractive modality and have the potential to drive an immune reset.

Scott Walshco: Whether that's achievable.

Scott Walshco: What the duration of that looks like what the side effect profile that looks like how many doses all of that's TBD or very early I think just generally in the field of autoimmunity that said I think one of the.

Scott Walshco: The potential strengths of an engager are that it can be multi-dosed. And I do think from our standpoint, as a company, we've always discussed the fact that an off-the-shelf cell therapy, we do think, has multi-dosing potential. I think multi-dosing potential can be hindered by side effects. Hence, as we've discussed, we think it's important to think about both 819 and 522 being developed as add-on strategies to standard regimens that are used today to treat patients in a community setting with autoimmune disease. And I think you will see us continue to move in that direction where we are thinking about delivering and dosing cell therapies as if they were monoclonal antibodies.

Scott Walshco: Potential strengths oven engage or is that it can be multi dosed and I do think from our standpoint as a company. We've always discussed the fact that an off the shelf cell therapy, we do think has multi dosing potential.

Scott Walshco: I think multi dosing potential can be hindered by size fleet conditioning, hence.

Scott Walshco: Hence as we've discussed we think it is important to think about both <unk> thousand 19 and $5 two two.

Scott Walshco: That being developed as an add on strategies to standard regimens that are used today to treat patients in the community setting with autoimmune disease.

Scott Walshco: And I think you will see us continue to move in that direction, where we are thinking about delivering and dosing cell therapies as if they were a monoclonal antibody.

Speaker Change: Got it very helpful. Thank you.

Scott Walshco: The next question comes from Bill Maughan with Canaccord Genuity. Please go ahead.

Operator: Very helpful. Thank you. [inaudible] Please go ahead.

Operator: Hi, thanks for taking the time to answer the question. So... Follow up on this morning's 819 data; all the PK was obviously positive, but thinking about translating that from an oncology patient to an autoimmune patient when antigen-dependent expansion is a key part of the PK of a CAR T-cell therapy, I'm just wondering how you think about translating from one population to another. Yeah, I think, you know, there's a lot we don't know with respect to how the two diseases are going to translate.

Speaker Change: Hi, Thanks for taking the question so.

Operator: To follow up on this mornings eight 109 data all of the PK, obviously, it was positive but thinking about translating that from.

Operator: From an oncology patient two in autoimmune patients when antigen dependent expansion is a key part of the PK of our car T cell therapy.

Operator: Just wondering how you think.

Operator: About being able to translate.

Operator: From that from one population to the next.

Speaker Change: Yes, I think.

Operator: There's a lot we don't know with respect to how the two diseases are going to translate I think.

Operator: I think what we have certainly seen with the PK is that we have seen CD19-mediated expansion that is dose-dependent. Certainly, the mechanism of action, or one of the key mechanisms of action in autoimmunity, is being able to recognize and target and eliminate CD19 positive B cells.

Speaker Change: What we have certainly seen with the PK is that we had seen CD 19 mediated expansion that is dose dependent.

Operator: Certainly the mechanism of action or one of the Mec in key mechanisms of action in autoimmunity is being able to recognize and target and eliminate CD 19 positive b cells. So I don't necessarily presume that.

Scott Walshco: So I don't necessarily presume that the PK profiles are necessarily going to be the same in oncology versus autoimmunity. I think at the end of the day, what's obviously critical is the kinetics and depth of B cell depletion. Thank you. The next question comes from Ethan Markowski with Needham and Company. Please go ahead. Hi, this is Ethan. I'm for Gil Bloom.

Ethan Thomas Markowski: Actually the PK profiles are necessarily going to be the same in oncology versus auto immunity I think at the end of the day, what's obviously critical as <unk>.

Ethan Thomas Markowski: The kinetics and depth of B cell depletion.

Ethan Thomas Markowski: Okay. Thank you.

Ethan Markowski: The next question comes from Eastern Mark Hausky with Needham and company. Please go ahead.

Ethan Thomas Markowski: Yes, Hi, this is Ethan on for Joe Bloom. Thank you for taking our question.

Ethan Markowski: Thank you for taking our question. So I'm just looking at the charts and the ASTCT data, and I think he has clearly shown that FT-522 demonstrates deeper B-cell depletion than FT-F9-6. But it looks like FT819's graph, at least the bar graph in depletion, is very similar to FT596 with some cells coming back up in the mid-to-end of the cycle. I was wondering first whether cells coming back at the end are clinically relevant. And then also just from a cost savings perspective, I know you're no longer.

Ethan Thomas Markowski: So I'm just looking at.

Ethan Thomas Markowski: The chart familiar GCT data.

Ethan Markowski: She is clearly show that.

Ethan Markowski: <unk> to.

Ethan Markowski: Demonstrated steeper b cell depletion then FTE at nine six.

Ethan Markowski: But it looks like ft, nine graph at least a bar graph in depletion is very similar to ft 506 with themselves.

Ethan Markowski: Kind of coming back up in the mid teens and of the cycle I was wondering first.

Ethan Markowski: How important.

Ethan Markowski: This complete responses.

Ethan Markowski: Some cells coming back at the end is clinically relevant.

Ethan Markowski: And then also just from a cost savings perspective, I know you are no longer.

Ethan Markowski: Planning to move forward in multiple myeloma and do cell lymphoma. So wondering if that has any impact in a positive way on near term R&D spend.

Speaker Change: Thank you for taking my question.

Scott Walshco: Yes.

Scott Walshco: On the last question with respect to clinical development of multiple myeloma, obviously, there are patient costs associated with clinical development.

Scott Walshco: That as.

Scott Walshco: Enhancing or saving or reducing BUM, or certainly investing in it. As it relates to B-cell depletion, I think, you know, keep in mind with both 819 as well as 522, we're seeing very, very low levels of cells in many instances, and I'll let Bob talk about it, you know, below the lower limit of sort of detection. And so when we start getting into very, very low levels, you start to And I don't believe, at least we think, that we're seeing different levels of depletion with 819 versus 522. I'll let Bob comment on that.

Scott Walshco: Enhancing our savings are reducing bumps are.

Scott Walshco: We're in that certainly investing in oil.

Scott Walshco: As it relates to B cell depletion I think keeping keep in mind with both 819 as well as $5 two two.

Bob: We are seeing very very low levels of cells.

Scott Walshco: In many instances and I'll, let Bob talk about it below lower limit of.

Scott Walshco: Detection and so when we start getting into very very low levels, you start to get into sort of.

Scott Walshco: Can you type discussion about whether it is a significant significant or not and I don't believe at least we think that we're seeing different levels of depletion with a 19 versus five two I'll, let Bob comment on that I will say just to be really clear 580, 819 dataset is over a much larger.

Bahram Valamehr: I will say, just to be really clear, the 819 data set is over a much larger data set of patients. I think we used 23 patients with B-cell lymphoma for that data set. Some of those patients had, you know, relatively high B-cell counts going into the study. In fact, we noted that there were certain patients that had supraphysiological levels of B-cell counts that we were able to deplete with FTA-19. The 522 data set is, I think, only on two patients, and their B-cell counts generally were lower at baseline compared to the totality of the, I think I'll let Bob talk about that, but I think, generally speaking, what we've seen with respect to B-cell reconstitution from the SHET data is B-cell reconstitution actually can happen as early as the third or fourth week and can happen as late as four months. But I' No, I think you have well covered it.

Bob: Data set of patients.

Bahram Valamehr: I think we used 23 patients with B cell b cell lymphoma for that data set some of those patients had relatively high b cell counts going into the study in fact, we noted that there were certain patients that had super physiological levels of B cell counts that we were able to deplete.

Bahram Valamehr: FTA 19.

Bahram Valamehr: Q2 dataset is.

Speaker Change: Only on two two patients.

Bahram Valamehr: And they are b cell counts generally were lower at baseline compared to the totality of the 19 patients.

Speaker Change: I think Jeff I'll, let Bob talk but yet on that but I think generally.

Bob: Generally speaking what we've seen with respect to B cell reconstitution from the shirt data is b cell reconstitution actually can happen as for instance, as early as the third or fourth week and can happen as late as four months.

Bahram Valamehr: But I'll, let Bob sort of finish up on that if I missed anything no I think you're well covered it well.

Bahram Valamehr: You know, when discussing A19, as Scott mentioned, that was a large number of patients, but it fell pretty much in line with showing very good B cell depletion over the treatment cycle. And B cell recovery was seen in some of the patients. Now, keep in mind, this is oncology. So what's coming back up could be a, you know, lymphoma cell or something. So we're in a much more aggressive stage than what SHED shows. But, as Scott mentioned, what SHED shows is that B cells do come back from 30 days to 180 days.

Bob: When discussing a 109 as Scott mentioned of the large number of patients, but it felt pretty much in line with showing very good b cell depletion over the treatment cycle and B cell recovery was seen in some of the patients now keep in mind. This is oncology, so what's coming back up could be.

Bahram Valamehr: Must sell or something so we are in a much more aggressive stage, then what shed showed but as Scott mentioned.

Bahram Valamehr: But shed showed is that b cell do come back from 30 days to 180 days. So every patient treated all 15 and share data had I believe day 180.

Bahram Valamehr: So every patient treated, all 15 in SHED's data, had, I believe, day 180 full recovery of B cells. So A19 is very much in line with what SHED showed. Now, with 522, you bring up a very good point. And I think part of that has to do with the fact that it's being combined with a toxin. So this is a kind of a one-two punch to every scene.

Bahram Valamehr: Full recovery of B cell. So 809 is very much in line with what shirt show now with $5 two to bring up at very good point and I think part of that has to do with the fact that it is being combined with rituxan. So that this is a.

Speaker Change: Kind of.

Bahram Valamehr: <unk> punched ever seen again, two patients I'm not going to sit here.

Bahram Valamehr: Again, two patients; I'm not going to sit here and speculate too much on it, but you are seeing the power of CAR plus HNCD 16 in these settings, and I think both programs' data has been very encouraging so far. And, Ethan, I'll just pick up on Scott's comments qualitatively. I agree the mix of the business will change through the course of the year, but if you look at the first quarter, we had, you know, roughly $52-$53 million in gap operating expenses and about $37 million in cash burn. That's been pretty consistent for the last couple of quarters.

Bahram Valamehr: Speculate too much on it but you are seeing the power of car plus agent CD 16 in these settings and <unk>.

Bahram Valamehr: And I think both programs are data has been so far very encouraging.

Ethan Thomas Markowski: And even I'll just pick up on Scott's comments qualitatively I agree the mix of the business will change through the course of the year, but if you look at the first quarter, we had roughly $52 $53 million in GAAP operating expenses and about $37 million in cash burn that's been pretty consistent for the last couple of quarters. So even though we have one or two programs winding down. The hope is that now that we have first patient.

Scott Walshco: So, even though we have one or two programs winding down, the hope is that now that we have the first patient dose and we're beginning to clear dose levels in certain programs, that will pick up throughout the year. So, I expect that those numbers I just quoted, you know, the $53 million on the gap operating expense and the $37-$38 million on the cash burn, the effective cash burn for the quarter, to remain fairly consistent.

Scott Walshco: Dose can we're beginning a clear dose levels in certain programs, that's going to pick up throughout the year. So I expect that those numbers I just quoted was $53 million on the GAAP operating expense in the 3700 $38 million on the cash burn effective cash burn for the quarter to remain fairly consistent I'm more than happy to invest find these clinical programs. So if that picks up to you.

Speaker Change: Thank you very helpful.

Scott Walshco: Thank you. This concludes our question and answer session. I would like to turn the conference back over to Scott Walshko for any closing remarks. Thank you. Thank you to everyone today, for all your good questions on the ASGCT data. Appreciate all the input and thought, and I'll speak to you soon. Thank you. This conference is now concluded. Thank you for attending today's presentation.

Scott Walshco: This concludes our question and answer session I would like to turn the conference back over to Scott Walsh for any closing remarks.

Scott Walshco: Thank you. Thank you for everyone today for all your good questions on the <unk> data I appreciate all the input and thought and.

Scott Walshco: Speak to you soon thank you.

Scott Walshco: The conference has now concluded. Thank you for attending today's presentation you may now disconnect.

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