Cone Dystrophy

Enrollment Ongoing with FT819 1XX CAR T-cell Product Candidate in Phase 1 Autoimmunity Study; Single-agent Cyclophosphamide Included as Alternative Conditioning Regimen First Patient Treated with FT522 CAR NK Cell Product Candidate in Conditioning-free Arm of Phase 1 B Cell Lymphoma Study FT522 Multi-indication IND Application for Conditioning-free Treatment of Autoimmune Diseases to be Submitted in 3Q24 Enrollment Ongoing with FT825 / ONO-8250 CAR T-cell Product Candidate as Monotherapy in Phase 1 Solid Tumor Study; Dosing in Combination with Monoclonal Antibody Therapy Expected to Initiate in 3Q24 $352 Million in Cash, Cash Equivalents, and Investments with Projected Operating Runway through YE26 SAN DIEGO, Aug. 13, 2024 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases, today reported business highlights and financial results for the second quarter ended June 30, 2024. “We are pleased with the initial clinical and translational observations from our three ongoing Phase 1 studies and look forward to sharing data from each program in the second half of 2024,” said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. “We remain keenly focused on achieving therapeutic differentiation in autoimmunity with our off-the-shelf FT819 CAR T-cell and FT522 CAR NK cell product candidates. Our ongoing FT819 study for systemic lupus erythematosus now includes single-agent cyclophosphamide as an alternative conditioning regimen for patients, and we are working to expand clinical investigation of FT819 to treat additional B cell-mediated diseases. We are also finalizing our FT522 IND submission for the treatment of a basket of autoimmune diseases without administration of conditioning chemotherapy to patients, having now treated the first patient without conditioning chemotherapy in our ongoing FT522 study for B cell lymphoma. In addition, under our solid tumor collaboration with Ono Pharmaceutical, we have now treated the first three patients as monotherapy with our multiplexed-engineered FT825 CAR T-cell collaboration candidate, and we are poised to initiate dosing in combination with monoclonal antibody therapy to explore the potential of dual-antigen targeting in advanced solid tumors.” FT819 iPSC-derived 1XX CAR T-cell Program Enrollment Ongoing in FT819 Phase 1 Autoimmunity Study. The multi-center, Phase 1 clinical trial for patients with systemic lupus erythematosus (SLE) is designed to evaluate the safety, pharmacokinetics, and anti-B cell activity of FT819, the Company’s off-the-shelf CD8αβ+ T-cell product candidate that incorporates a CD19-targeted chimeric antigen receptor (CAR) with a novel 1XX costimulatory domain into the T-cell receptor alpha constant (TRAC) locus (NCT06308978). The first patient treated in the study, a 27 year-old woman diagnosed with lupus nephritis over ten years ago who has refractory disease despite having been treated with multiple standard-of-care therapies, received conditioning chemotherapy followed by a single dose of FT819 at 360 million cells. The patient remains on-study, and there have been no Grade ≥3 adverse events and no events of any grade of cytokine release syndrome (CRS), immune effector-cell associated neurotoxicity syndrome (ICANS), or graft-versus-host disease (GvHD). The Company plans to present clinical and translational data from the Phase 1 study at a medical conference in the second half of 2024.Single-agent Cyclophosphamide Included as Alternative Conditioning Regimen. In addition to conditioning of patients with either cyclophosphamide and fludarabine (Cy / Flu) or bendamustine, the Company amended the clinical protocol of its FT819 Phase 1 autoimmunity study to include single-agent cyclophosphamide (Cy) as a third conditioning regimen. Cy is a commonly-used agent with an established safety profile for the treatment of patients with B cell-mediated autoimmune diseases.Favorable Safety Profile and Proof-of-Concept for Autoimmune Disease Established in FT819 Phase 1 BCM Study. At the American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting in May, the Company presented clinical and translational data from its FT819 Phase 1 study in relapsed / refractory B cell malignancies (BCM) (NCT04629729). 43 heavily pre-treated patients were treated with conditioning chemotherapy and a single dose of FT819 across five dose levels. The safety and tolerability profile of FT819 was favorable, with no dose-limiting toxicities, no events of any grade of ICANS or GvHD, and low incidence (14%) of low-grade CRS. In addition, a single dose of FT819 exhibited multiple mechanisms implicated in generating an immune reset in patients with B cell-mediated autoimmune diseases, including rapid, deep, and sustained CD19+ B-cell depletion in the periphery throughout the one-month treatment cycle as well as primary, secondary, and tertiary tissue trafficking, infiltration, and activity with CD19+ B cell elimination in tissue. The Company successfully completed dose escalation in its FT819 Phase 1 BCM study, and has focused further clinical development of FT819 exclusively in autoimmunity. FT825 / ONO-8250 iPSC-derived CAR T-cell Program Enrollment Ongoing in Phase 1 Study with HER2-targeted CAR T-cell for Advanced Solid Tumors. Under its collaboration with Ono Pharmaceutical Co., Ltd. (Ono), the Company is conducting a multi-center, Phase 1 study to assess the safety, pharmacokinetics, and activity of FT825 / ONO-8250 as monotherapy and in combination with monoclonal antibody therapy in patients with advanced solid tumors (NCT06241456). Designed using the Company’s iPSC product platform, FT825 / ONO-8250 incorporates seven synthetic controls of cell function including a novel cancer-specific H2CasMab-2 CAR, which has exhibited similar potency with greater specificity for cancer cells expressing HER2 compared to trastuzumab in preclinical studies. Three patients have been treated in the Phase 1 study with a single dose of FT825 / ONO-8250 as monotherapy at the first dose level of 100 million cells and, during the third quarter of 2024, the Company plans to initiate enrollment as monotherapy at the second dose level of 300 million cells and in combination with epidermal growth factor receptor (EGFR)-targeted monoclonal antibody therapy at the first dose level of 100 million cells. The Company plans to present clinical and translational data from the Phase 1 study at a medical conference in the second half of 2024. FT522 iPSC-derived CAR NK Cell Program First Patient Treated without Conditioning in Phase 1 BCL Study. FT522 is the Company’s off-the-shelf, CD19-targeted CAR NK cell product candidate and its first to incorporate Alloimmune Defense Receptor (ADR) technology, which is designed to reduce or eliminate the need for administration of conditioning chemotherapy to patients receiving cell therapies. In its ongoing multi-center, Phase 1 clinical trial of FT522 in patients with relapsed / refractory B-cell lymphoma (BCL) (NCT05950334), the first patient has now been treated in the first three-dose cohort at 300 million cells per dose without conditioning chemotherapy (Regimen B). In addition, the first patient has now been treated in the second three-dose cohort at 900 million cells per dose with conditioning chemotherapy (Regimen A). No dose-limiting toxicities and no events of any grade of CRS, ICANS, or GvHD, have been reported in the Phase 1 study. The Company plans to present clinical and translational data from the Phase 1 study at a medical conference in the second half of 2024.IND Application for Phase 1 Basket Study in Autoimmunity to be Submitted in 3Q24. The Company intends to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in the third quarter of 2024 for the treatment of a basket of B cell-mediated autoimmune diseases with FT522, including without administration of conditioning chemotherapy to patients. At the ASGCT conference, the Company presented preclinical data from a novel re-challenge assay using peripheral blood mononuclear cells (PBMCs) from unmatched SLE donors, showing that FT522 uniquely drove rapid and deep CD19+ B cell depletion, eliminated alloreactive T cells, and maintained functional persistence, indicating that FT522 can function effectively in the presence of an unmatched host immune system. The Company also shared initial clinical observations from the first two patients treated with FT522 at 100 million cells per dose in Regimen A of its ongoing Phase 1 BCL study, which showed rapid, deep, and sustained B-cell depletion in the periphery throughout the one-month treatment cycle. In addition, both patients showed enhanced persistence of FT522 in the periphery compared to clinical data observed with FT596, a prior-generation CD19-targeted CAR NK cell without ADR technology. Second Quarter 2024 Financial Results Cash & Investment Position: Cash, cash equivalents and investments as of June 30, 2024 were $352.0 million.Total Revenue: Revenue was $6.8 million for the second quarter of 2024, which was derived from the achievement of a $5 million milestone in connection with the clinical development of FT825 / ONO-8250 and the conduct of preclinical development activities for a second collaboration candidate targeting an undisclosed solid tumor antigen under its collaboration with Ono.Total Operating Expenses: For the second quarter of 2024, GAAP operating expenses were $51.9 million, including research and development expenses of $34.6 million and general and administrative expenses of $17.3 million. Such amounts included $9.6 million of non-cash stock-based compensation expense.Shares Outstanding: Common shares outstanding were 113.8 million, pre-funded warrants outstanding were 3.9 million, and preferred shares outstanding were 2.8 million, as of June 30, 2024. Each preferred share is convertible into five common shares. About Fate Therapeutics’ iPSC Product PlatformHuman induced pluripotent stem cells (iPSCs) possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s proprietary iPSC product platform combines multiplexed-engineering of human iPSCs with single-cell selection to create clonal master iPSC lines. Analogous to master cell lines used to mass produce biopharmaceutical drug products such as monoclonal antibodies, the Company utilizes its clonal master iPSC lines as a starting cell source to manufacture engineered cell products which are well-defined and uniform in composition, can be stored in inventory for off-the-shelf availability, can be combined and administered with other therapies, and can potentially reach a broad patient population. As a result, the Company’s platform is uniquely designed to overcome numerous limitations associated with the manufacture of cell therapies using patient- or donor-sourced cells. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 500 issued patents and 500 pending patent applications. About Fate Therapeutics, Inc.Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered master iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s pipeline includes iPSC-derived natural killer (NK) cell and T-cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com. Forward-Looking StatementsThis release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the Company’s results of operations, financial condition, anticipated operating expenses and cash runway, and sufficiency of its cash and cash equivalents to fund its operations, as well as statements regarding the advancement of and plans related to the Company's product candidates, clinical studies and preclinical research and development programs, the Company’s progress, plans and timelines for the clinical investigation of its product candidates, including the initiation and continuation of enrollment in the Company’s clinical trials, the initiation of additional clinical trials and additional dose cohorts in ongoing clinical trials of the Company’s product candidates, the availability of data from the Company’s clinical trials, the Company’s plans to submit additional IND applications for its product candidates and the timing thereof, the therapeutic and market potential of the Company’s research and development programs and product candidates, the Company’s clinical and product development strategy, and the Company’s expectations regarding progress and timelines, and the objectives, plans and goals of its collaboration with Ono. These and any other forward-looking statements in this release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the Company’s research and development programs and product candidates, including those product candidates in clinical investigation, may not demonstrate the requisite safety, efficacy, or other attributes to warrant further development or to achieve regulatory approval, the risk that results observed in prior studies of the Company’s product candidates, including preclinical studies and clinical trials, will not be observed in ongoing or future studies involving these product candidates, the risk of a delay or difficulties in the manufacturing of the Company’s product candidates or in the initiation and conduct of, or enrollment of patients in, any clinical trials, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials, changes in the therapeutic, regulatory, or competitive landscape for which the Company’s product candidates are being developed, the amount and type of data to be generated or otherwise to support regulatory approval, difficulties or delays in patient enrollment and continuation in the Company’s ongoing and planned clinical trials, difficulties in manufacturing or supplying the Company’s product candidates for clinical testing, failure to demonstrate that a product candidate has the requisite safety, efficacy, or other attributes to warrant further development, and any adverse events or other negative results that may be observed during preclinical or clinical development), the risk that its product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects, the risk that the Company may not comply with its obligations under and otherwise maintain its collaboration agreement with Ono, the risk that research funding and milestone payments received by the Company under its collaboration may be less than expected, and the risk that the Company may incur operating expenses in amounts greater than anticipated. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Company’s periodic filings with the Securities and Exchange Commission, including but not limited to the Company’s most recently filed periodic report, and from time to time in the Company’s press releases and other investor communications. Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise. Condensed Consolidated Statements of Operations and Comprehensive Loss(in thousands, except share and per share data)(unaudited) Three Months Ended Six Months Ended June 30, June 30, 2024 2023 2024 2023 Collaboration revenue$6,772 $933 $8,697 $59,913 Operating expenses: Research and development 34,604 40,876 66,742 106,505 General and administrative 17,251 22,622 38,106 44,565 Total operating expenses 51,855 63,498 104,848 151,070 Loss from operations (45,083) (62,565) (96,151) (91,157)Other income (expense): Interest income 4,827 4,381 8,976 8,075 Change in fair value of stock price appreciation milestones 1,556 393 162 2,111 Other Income 273 5,036 582 9,335 Total other income (expense), net 6,656 9,810 9,720 19,521 Net loss$(38,427) $(52,755) $(86,431) $(71,636)Other comprehensive income (loss): Unrealized (loss) gain on available-for-sale securities, net (228) 59 (437) 1,267 Comprehensive loss$(38,655) $(52,696) $(86,868) $(70,369)Net loss per common share, basic and diluted$(0.33) $(0.54) $(0.79) $(0.73)Weighted–average common shares used to compute basic and diluted net loss per share 117,468,124 98,400,355 109,286,235 98,228,476 Condensed Consolidated Balance Sheets(in thousands)(unaudited) June 30, December 31, 2024 2023 Assets Current assets: Cash and cash equivalents$36,917 $41,870 Accounts receivable 1,048 1,826 Short-term investments 267,962 273,305 Prepaid expenses and other current assets 13,461 14,539 Total current assets 319,388 331,540 Long-term investments 47,162 980 Operating lease right-of-use asset 59,547 61,675 Other long-term assets 102,720 112,022 Total assets$528,817 $506,217 Liabilities and stockholders’ equity Current liabilities: Accounts payable and accrued expenses$28,149 $32,233 Deferred revenue --- 685 Operating lease liability, current portion 6,644 6,176 Total current liabilities 34,793 39,094 CIRM award liability 1,940 --- Operating lease liability, net of current portion 93,918 97,360 Stock price appreciation milestones 1,184 1,346 Stockholders’ equity 396,982 368,417 Total liabilities and stockholders’ equity$528,817 $506,217 Contact:Christina Tartaglia Precision AQ 212.362.1200 christina.tartaglia@precisionaq.com

Challenges to inclusive design often stem from viewing disability as a binary status. However, disabilities vary widely in severity and permanency, with symptoms existing on a spectrum. One in 4 adults in the U.S. has a temporary or permanent disability, including visual, auditory, cognitive and mobility impairments—a number that will climb as the population ages. Nearly half (46%) of Americans aged 75 and older report having a disability compared to just 24% of those 65 to 74 and 12% of those 35 to 46. The prevalence of disability is why the health IT developer community must prioritize electronic health record (EHR) designs that advance disability inclusion across healthcare, allowing patients, providers and other healthcare workers requiring accommodation to fully and effectively participate in both the provision and receipt of healthcare. What disability exclusion looks like   Technology has been the solution to so many daily challenges that it can be difficult to view it as anything but helpful. Often, however, the features that make technology user-friendly for most can block some healthcare professionals with disabilities from performing their core responsibilities. Spending a day observing EHR users lays bare the accessibility issues with health IT tools for users with specific disabilities: Drop-down menus make it difficult for someone whose severe rheumatoid arthritis or hand injury affects their ability to use a mouse for electronic charting. Using color alone, like red for critical alerts and blue or green for notifications, may not have the desired effect on someone with a color vision deficiency, which could in turn create patient safety issues. Patients with low vision struggle to message providers without an option to zoom in on text. Drag and drop design elements are challenging for those with hand injuries or other issues that make gripping or maneuvering a mouse problematic. In some cases, design or coding choices can hinder the accessibility solution. A clinician with low vision shared a story with the EHR Association User Experience Workgroup about how she was stopped in her tracks during a patient exam by an unlabeled button on an EHR screen. The missing label caused her screen reader to just repeat the word “button,” forcing her to stop what she was doing until a colleague could help—a disruption that could have been avoided by properly labeling the button with the required input.  The clinician was frustrated at both the disruption to her care process and the need to rely on a colleague to successfully perform such a basic task because of a missing label. Understanding the disability spectrum   Challenges to inclusive design often stem from viewing disability as a binary status. However, disabilities vary widely in severity and permanency, with symptoms existing on a spectrum. For instance, blindness can mean low vision rather than total vision loss. Similarly, a wheelchair user may have some ability to stand or walk. Temporary disabilities can result from injuries or illness, while conditions like multiple sclerosis, Parkinson's and diabetes can cause fluctuations between “abled” and “disabled.” Thus, disability should be defined as: Temporary, affecting an individual for a short time. These are typically illnesses or injuries that keep someone from fully participating in routine activities until they recover. Permanent, affecting the individual for life. This could be an illness or injury from which there is no recovery, or it could be present from birth.  Episodic, permanent conditions (e.g., diabetes and multiple sclerosis) for which there are no cures and severity changes from one day to the next. People with episodic disabilities like vertigo, migraines and some forms of mental illness experience random periods of fluctuating good health and ill health. Situational, affected by someone’s environment or circumstances (e.g., difficulty hearing information in noisy or crowded rooms). Dynamic, randomly shifting in severity or fluctuating over time (e.g., a flair-up of a chronic illness or pain). Basing accessibility designs on a binary definition of disability can lead to EHR features that make technology user-friendly for some healthcare professionals with disabilities but create obstacles for others. A better approach   The better approach to accessible EHRs is to consider all the challenges design elements create for individuals with a range of issues and then build functionality that allows for multiple options. For example, keystrokes, mouse clicks and voice commands can all be used to achieve the same outcome regardless of the type or severity of dexterity issues. Design elements can also leverage the multitude of assistive technologies already available—such as subtitles and/or transcripts on video content to assist those with hearing impairments—and adjust them to meet specific disability needs. For example, ensuring touch targets are sized large enough in mobile applications to be easily activated by users with low vision or dexterity limitations. Inclusion benefits all   By moving away from a binary definition of disability and taking time to observe how users access and interact with health IT in the real world, we can identify design elements that overcome obstacles at any point along the disability spectrum. When that understanding is incorporated into the design and tested by people with a range of disability types to ensure efficacy, it brings us closer to truly inclusive EHRs and other health IT—which benefits all. Tammy Coutts is the lead software designer for user experience and usability at EHR vendor MEDITECH as well as the vice chair of the EHR Association's User Experience Workgroup. Also contributing to this piece were fellow workgroup members Libby Eddings, senior inclusion and accessibility user experience designer at Oracle Health; Mike Shonty, lead software designer at MEDITECH; and Jennifer Sagerian, manager of user experience and design system as well as accessibility program lead at MEDITECH.

First Lupus Patient Treated with FT819 CAR T-cell Product Candidate in Phase 1 Autoimmunity Study; Future Clinical Development of FT819 to Focus Exclusively on Autoimmune Disease Enrollment Initiated with FT522 CAR NK Cell Product Candidate in Conditioning-free Treatment Arm of Phase 1 B Cell Lymphoma Study First Patient Treated with FT825 / ONO-8250 CAR T-cell Product Candidate in Phase 1 Solid Tumor Study $391 Million in Cash, Cash Equivalents, and Investments SAN DIEGO, May 09, 2024 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases, today reported business highlights and financial results for the first quarter ended March 31, 2024. “We made great progress across three key areas of clinical focus – we treated the first patient with our off-the-shelf FT819 CAR T-cell therapy for autoimmunity, we initiated patient enrollment without conditioning chemotherapy for our ADR-armed FT522 CAR NK cell therapy, and we treated the first patient with our multiplexed-engineered FT825 CAR T-cell therapy for solid tumors,” said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. “As we look toward the middle of the year, we plan to expand clinical development in autoimmunity with our off-the-shelf FT819 and FT522 programs, where we believe our iPSC product platform is highly differentiated and has the potential to overcome numerous challenges that hinder treatment of patients with cell therapies, such as the requirement for apheresis and Cy / Flu conditioning, extended hospitalization, risk of secondary malignancies, and limited access. In addition, while we continue with the preclinical assessment of our next-generation, BCMA-targeted cell product candidates, we do not intend to further advance FT576 into Phase 1 dose expansion in relapsed / refractory multiple myeloma.” FT819 iPSC-derived CAR T-cell Program First SLE Patient Treated in Phase 1 Autoimmunity Study. The multi-center, Phase 1 clinical trial for patients with systemic lupus erythematosus (SLE) is designed to evaluate the safety, pharmacokinetics, and anti-B cell activity of FT819, the Company’s off-the-shelf CD8αβ+ T-cell product candidate that incorporates a novel CD19-targeted 1XX chimeric antigen receptor (CAR) construct into the T-cell receptor alpha constant (TRAC) locus (NCT06308978). The first patient, a 27 year-old woman diagnosed with SLE over ten years ago who has refractory disease despite having been treated with multiple standard-of-care therapies, received conditioning chemotherapy followed by a single dose of FT819 at 360 million cells. The patient was discharged after a three-day hospital stay without any notable adverse events. In a "first-of-kind" translational assessment using a sample of the patient’s blood obtained prior to administration of conditioning chemotherapy, FT819 induced rapid and potent depletion of the patient’s CD19+ B cells in an ex vivo cytotoxicity assay.Phase 1 BCM Study Data Establish Proof-of-Concept for Autoimmune Disease. At the American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting, the Company today presented preclinical and translational data from its FT819 Phase 1 study in relapsed / refractory B cell malignancies (BCM), which showed that a single dose of FT819 exhibits multiple mechanisms implicated in generating an immune reset in patients with B cell-mediated autoimmune diseases. Clinical observations included: dose-dependent pharmacokinetics, reaching Cmax at Day 8 with persistence through the first two weeks in the periphery; rapid, deep, and sustained CD19+ B cell depletion in the peripheral blood using standard Cy / Flu and alternative conditioning chemotherapy regimens; patient case studies of secondary and tertiary tissue trafficking, infiltration, and activity with CD19+ B cell elimination in tissue; and patient case studies of plasma cell depletion and B cell reconstitution, which showed recovery of naïve B cells with little to no recovery of activated memory B cells or plasmablasts.Dose-escalation Completed in Phase 1 BCM Study with Further Clinical Development to Focus Exclusively on Autoimmunity. The Company has successfully completed dose escalation in its Phase 1 BCM study, demonstrating safety and tolerability of FT819 at a single dose up to 1.08 billion cells (NCT04629729), and intends to pursue further clinical development exclusively in autoimmunity. 43 heavily pre-treated patients (B cell lymphoma, n=25; chronic lymphocytic leukemia, n=12; and acute lymphocytic leukemia, n=6) were treated with conditioning chemotherapy and a single dose of FT819 across five dose levels. The safety and tolerability profile of FT819 was favorable, with no dose-limiting toxicities, no events of any grade of immune effector-cell associated neurotoxicity syndrome (ICANS) or graft-versus-host disease (GvHD), and low incidence (14%) of only low-grade cytokine release syndrome (CRS). There were no study discontinuations or deaths related to FT819. Clinical responses were observed across all three histologies. In 17 patients with aggressive large B cell lymphoma, 12 (71%) of whom had previously received autologous CD19-targeted CAR T-cell therapy, the overall response and complete response rates were 47% and 24%, respectively. FT825 / ONO-8250 iPSC-derived CAR T-cell Program First Patient Treated in Phase 1 Study with HER2-targeted CAR T-cell for Advanced Solid Tumors. Under its collaboration with Ono Pharmaceutical Co., Ltd. (Ono), the Company is conducting a multi-center, Phase 1 study to assess the safety, pharmacokinetics, and activity of FT825 / ONO-8250 as monotherapy and in combination with monoclonal antibody therapy in patients with advanced solid tumors (NCT06241456). The first patient was diagnosed with HER2-positive gastroesophageal junction (GEJ) adenocarcinoma, had progressed after receiving multiple lines of treatment including HER2-targeted therapies, and was administered standard conditioning chemotherapy followed by a single dose of FT825 / ONO-8250 as monotherapy at 100 million cells. Designed using the Company’s iPSC product platform, FT825 / ONO-8250 incorporates seven synthetic controls of cell function including a novel cancer-specific H2CasMab-2 CAR, which has exhibited similar potency with greater specificity for cancer cells expressing HER2 compared to trastuzumab in preclinical studies. FT522 iPSC-derived CAR NK Cell Program Conditioning-free Treatment Arm of Phase 1 BCL Study Open for Enrollment. FT522 is the Company’s off-the-shelf, CD19-targeted CAR NK cell product candidate and its first to incorporate Alloimmune Defense Receptor (ADR) technology, which is designed to reduce or eliminate the need for administration of conditioning chemotherapy to patients receiving cell therapies. In its ongoing multi-center, Phase 1 clinical trial of FT522 in patients with relapsed / refractory B-cell lymphoma (BCL) (NCT05950334), patient enrollment has now been initiated in the first three-dose cohort at 300 million cells per dose without conditioning chemotherapy (Regimen B). Three patients have been treated with conditioning chemotherapy in the first three-dose cohort at 300 million cells per dose (Regimen A). There were no dose-limiting toxicities and no events of any grade of CRS, ICANS, or GvHD, and dose escalation is ongoing at 900 million cells per dose.ASGCT Presentation Data Show ADR Differentiation and Proof-of-Concept for Autoimmunity. At the ASGCT conference, the Company today presented preclinical data as well as early translational data from its ongoing Phase 1 BCL study. In a novel re-challenge assay using peripheral blood mononuclear cells (PBMCs) from unmatched SLE donors, FT522 uniquely drove rapid and deep CD19+ B cell depletion, eliminated alloreactive T cells, and maintained functional persistence, indicating that FT522 can function effectively in the presence of an unmatched host immune system. The Company also shared initial clinical observations from the first two patients treated with FT522 in Regimen A, which showed rapid, deep, and sustained B-cell depletion in the periphery throughout the one-month treatment cycle. In addition, both patients showed enhanced persistence of FT522 in the periphery compared to clinical data observed with FT596, a prior-generation CD19-targeted CAR NK cell without ADR technology. The Company intends to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in the middle of 2024 for the treatment of various autoimmune diseases with FT522, including without administration of conditioning chemotherapy to patients. FT576 iPSC-derived CAR NK Cell Program Dose Escalation Completed in Phase 1 Multiple Myeloma Study. The Company has completed dose escalation in its multi-center, Phase 1 clinical trial of FT576, its BCMA-targeted CAR NK cell product candidate, for relapsed / refractory multiple myeloma (NCT05182073). Using a standard conditioning chemotherapy regimen, 12 patients were treated with a three-dose treatment schedule at 1 billion cells per dose (n=6) or at 2.5 billion cells per dose (n=6) as monotherapy or in combination with CD38-targeted monoclonal antibody therapy. There were no dose-limiting toxicities and no events of any grade of CRS, ICANS or GvHD. Response assessment is ongoing at 2.5 billion cells per dose. Five of six (83%) heavily pre-treated patients achieved a clinical response at 1 billion cells per dose, including two penta-exposed patients treated with FT576 as monotherapy that achieved very good partial responses. The Company is continuing to assess the FT576 Phase 1 dose-escalation dataset and to preclinically evaluate the potential of its next-generation, BCMA-targeted cell product candidates, including for the treatment of multiple myeloma and autoimmune diseases, and does not intend to further advance FT576 into Phase 1 dose expansion in relapsed / refractory multiple myeloma. First Quarter 2024 Financial Results Cash & Investment Position: Cash, cash equivalents and investments as of March 31, 2024 were $391.1 million, which includes net proceeds from the closing of the Company’s approximately $80 million underwritten offering of common stock at $5.50 per share and approximately $20 million concurrent private placement of pre-funded warrants at $5.499 per pre-funded warrant in the first quarter of 2024.Total Revenue: Revenue was $1.9 million for the first quarter of 2024, which was derived from the Company’s conduct of preclinical development activities for a second collaboration candidate targeting an undisclosed solid tumor antigen under its collaboration with Ono.Total Operating Expenses: For the first quarter of 2024, GAAP operating expenses were $53.0 million, including research and development expenses of $32.1 million and general and administrative expenses of $20.9 million. Such amounts included $11.0 million of non-cash stock-based compensation expense.Shares Outstanding: Common shares outstanding were 113.8 million, pre-funded warrants outstanding were 3.9 million, and preferred shares outstanding were 2.8 million, as of March 31, 2024. Each preferred share is convertible into five common shares. Today's Conference Call and WebcastThe Company will conduct a conference call today, Thursday, May 9, 2024 at 5:00 p.m. ET to review financial and operating results for the quarter and full year ended March 31, 2024. In order to participate in the conference call, please dial (833) 630-1956 (domestic) and (412) 317-1837 (international). The live webcast can be accessed under "Events & Presentations" in the Investors section of the Company's website at www.fatetherapeutics.com. The archived webcast will be available on the Company's website beginning approximately two hours after the event. About Fate Therapeutics’ iPSC Product PlatformHuman induced pluripotent stem cells (iPSCs) possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s proprietary iPSC product platform combines multiplexed-engineering of human iPSCs with single-cell selection to create clonal master iPSC lines. Analogous to master cell lines used to mass produce biopharmaceutical drug products such as monoclonal antibodies, the Company utilizes its clonal master iPSC lines as a starting cell source to manufacture engineered cell products which are well-defined and uniform in composition, can be stored in inventory for off-the-shelf availability, can be combined and administered with other therapies, and can potentially reach a broad patient population. As a result, the Company’s platform is uniquely designed to overcome numerous limitations associated with the manufacture of cell therapies using patient- or donor-sourced cells. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 500 issued patents and 500 pending patent applications. About Fate Therapeutics, Inc.Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered master iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s pipeline includes iPSC-derived natural killer (NK) cell and T-cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com. Forward-Looking StatementsThis release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the Company’s results of operations, financial condition, anticipated operating expenses and cash runway, and sufficiency of its cash and cash equivalents to fund its operations, as well as statements regarding the advancement of and plans related to the Company's product candidates, clinical studies and preclinical research and development programs, the Company’s progress, plans and timelines for the clinical investigation of its product candidates, including the initiation and continuation of enrollment in the Company’s clinical trials, the initiation of additional clinical trials and additional dose cohorts in ongoing clinical trials of the Company’s product candidates, the availability of data from the Company’s clinical trials, the therapeutic and market potential of the Company’s research and development programs and product candidates, the Company’s clinical and product development strategy, and the Company’s expectations regarding progress and timelines, and the objectives, plans and goals of its collaboration with Ono. These and any other forward-looking statements in this release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the Company’s research and development programs and product candidates, including those product candidates in clinical investigation, may not demonstrate the requisite safety, efficacy, or other attributes to warrant further development or to achieve regulatory approval, the risk that results observed in prior studies of the Company’s product candidates, including preclinical studies and clinical trials, will not be observed in ongoing or future studies involving these product candidates, the risk of a delay or difficulties in the manufacturing of the Company’s product candidates or in the initiation and conduct of, or enrollment of patients in, any clinical trials, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials, changes in the therapeutic, regulatory, or competitive landscape for which the Company’s product candidates are being developed, the amount and type of data to be generated or otherwise to support regulatory approval, difficulties or delays in patient enrollment and continuation in the Company’s ongoing and planned clinical trials, difficulties in manufacturing or supplying the Company’s product candidates for clinical testing, failure to demonstrate that a product candidate has the requisite safety, efficacy, or other attributes to warrant further development, and any adverse events or other negative results that may be observed during preclinical or clinical development), the risk that its product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects, the risk that the Company may not comply with its obligations under and otherwise maintain its collaboration agreement with Ono, the risk that research funding and milestone payments received by the Company under its collaboration may be less than expected, and the risk that the Company may incur operating expenses in amounts greater than anticipated. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Company’s periodic filings with the Securities and Exchange Commission, including but not limited to the Company’s most recently filed periodic report, and from time to time in the Company’s press releases and other investor communications. Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise. Condensed Consolidated Statements of Operations and Comprehensive Loss(in thousands, except share and per share data)(unaudited) Three Months Ended March 31, 2024 2023 Collaboration revenue $1,925 $58,980 Operating expenses: Research and development 32,138 65,629 General and administrative 20,855 21,943 Total operating expenses 52,993 87,572 Loss from operations (51,068) (28,592)Other income (expense): Interest income 4,149 3,694 Change in fair value of stock price appreciation milestones (1,394) 1,718 Other income 309 4,299 Total other income (expense), net 3,064 9,711 Net loss $(48,004) $(18,881)Other comprehensive gain (loss): Unrealized gain (loss) on available-for-sale securities, net (209) 1,208 Comprehensive loss $(48,213) $(17,673)Net loss per common share, basic and diluted $(0.47) $(0.19)Weighted-average common shares used tocompute basic and diluted net loss per share 101,104,345 98,054,687 Condensed Consolidated Balance Sheets(in thousands)(unaudited) March 31, December 31, 2024 2023 Assets Current assets: Cash and cash equivalents $121,322 $41,870 Accounts receivable 858 1,826 Short-term investments 262,222 273,305 Prepaid expenses and other current assets 9,973 14,539 Total current assets 394,375 331,540 Long-term investments 7,595 980 Operating lease right-of-use asset 60,620 61,675 Other long-term assets 107,302 112,022 Total assets $569,892 $506,217 Liabilities and stockholders’ equity Current liabilities: Accounts payable and accrued expenses $38,808 $32,233 Deferred revenue 159 685 Operating lease liability, current portion 6,402 6,176 Total current liabilities 45,369 39,094 Operating lease liability, net of current portion 95,668 97,360 Stock price appreciation milestones 2,740 1,346 Stockholders’ equity 426,115 368,417 Total liabilities and stockholders’ equity $569,892 $506,217 Contact:Christina TartagliaStern Investor Relations, Inc.212.362.1200christina.tartaglia@sternir.com