Fate Therapeutics(FATE)

Search documents
Fate Therapeutics(FATE) - 2020 Q4 - Earnings Call Transcript
2021-02-25 05:18
Financial Data and Key Metrics Changes - Revenue for Q4 2020 was $15.9 million, a significant increase from $2.8 million in the same period last year, primarily driven by collaborations with Janssen and ONO Pharmaceutical [40][41] - Research and development expenses rose to $39 million from $25.2 million year-over-year, attributed to increased employee headcount and compensation [43] - General and administrative expenses increased to $10.3 million from $6.7 million, also due to higher headcount and compensation [44] - The company ended Q4 2020 with $483 million in cash, cash equivalents, and investments, excluding approximately $432 million from a January 2021 public equity offering [47] Business Line Data and Key Metrics Changes - The FT516 program for B cell malignancies showed promising interim data, with patients achieving objective responses, including complete responses in a Phase 1 study [12][14] - FT596 demonstrated a partial response in a heavily pretreated patient with diffuse large B cell lymphoma, indicating its potential effectiveness [16][18] - The company is advancing FT538, the first CRISPR-edited iPSC-derived cell product, with ongoing dose escalation for relapsed refractory AML [24][25] Market Data and Key Metrics Changes - The company is focusing on the AML market, where there is a significant opportunity for off-the-shelf NK cell therapy, particularly for relapsed refractory patients [23] - The multiple myeloma market is also a key focus, with the company developing FT576, which incorporates multiple functional components for enhanced efficacy [28][30] Company Strategy and Development Direction - The company aims to pioneer cell therapy using iPSC technology, focusing on engineered NK cells and CAR T cells to address unmet medical needs in various cancers [8][21] - There is a strategic emphasis on multi-antigen targeting and combination therapies to enhance treatment efficacy in hematologic malignancies [65][74] - The company plans to expand clinical investigations into solid tumors, leveraging the unique properties of NK cells [32][33] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the clinical progress made and the potential for engineered iPSC-derived NK cells to provide significant therapeutic benefits [11][32] - The company is encouraged by the safety profiles observed in clinical trials, particularly the absence of severe adverse events associated with NK cell therapies [90] - Management highlighted the importance of data-driven decisions in advancing their pipeline and exploring new treatment regimens [60][64] Other Important Information - The company is preparing to submit IND applications for new CAR NK cell programs targeting various solid tumors [37] - Data from the Phase 2 PROTECT trial for ProTmune is expected in Q2 2021, focusing on preventing acute GvHD in transplant patients [38] Q&A Session Summary Question: Strategy for additional partnerships - The company has the bandwidth to pursue additional partnerships and expand existing collaborations [49] Question: AML program initiation and strategy - The long-term vision for AML includes targeted strategies, with a focus on combining FT538 with daratumumab [50][51] Question: Viability of conditioning regimens - The company is exploring the tolerability of conditioning regimens and considering alternatives to fludarabine and cyclophosphamide [52][56] Question: NK cell pipeline evolution - The company is committed to developing both NK cell and CAR T cell therapies, with a focus on advancing both pipelines [58][60] Question: Dosing paradigm for FT516 expansion cohort - The expansion cohort will likely continue with the existing treatment paradigm while also experimenting with new dosing regimens [61][62] Question: Myeloma franchise strategy - The company is open to advancing both FT538 and FT576 based on clinical data, with a focus on multi-antigen targeting [64] Question: CD38 screening in AML trials - The company will not screen for CD38 in advance but will assess it through bone marrow biopsies during the trial [66] Question: Status update on FT819 - The first manufacturing run for FT819 has been completed, and the company is working on product release testing, aiming to enroll the first patient by mid-2021 [96]
Fate Therapeutics(FATE) - 2020 Q4 - Annual Report
2021-02-23 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission file number 001-36076 FATE THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 65-1311552 (State or o ...
Fate Therapeutics(FATE) - 2020 Q3 - Earnings Call Transcript
2020-11-06 21:13
Fate Therapeutics, Inc. (NASDAQ:FATE) Q3 2020 Earnings Conference Call November 5, 2020 5:00 PM ET Company Participants Scott Wolchko - President and Chief Executive Officer Edward Dulac - Chief Financial Officer Dan Shoemaker - Chief Scientific Officer Bob Valamehr - Chief Development Officer Wayne Chu - Senior Vice President, Clinical Development Conference Call Participants Matt Biegler - Oppenheimer Kelsey Goodwin - Guggenheim Securities Ben Burnett - Stifel Biren Amin - Jefferies Daina Graybosch - SVB ...
Fate Therapeutics(FATE) - 2020 Q3 - Quarterly Report
2020-11-05 21:07
I think UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2020 OR ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE ACT OF 1934 From the transition period from to . Commission File Number 001-36076 FATE THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 65-1311552 (State or other jurisdict ...
Fate Therapeutics(FATE) - 2020 Q2 - Earnings Call Transcript
2020-08-06 02:41
Fate Therapeutics, Inc. (NASDAQ:FATE) Q2 2020 Earnings Conference Call August 5, 2020 5:30 PM ET Company Participants Scott Wolchko - President & Chief Executive Officer Dan Shoemaker - Chief Scientific Officer Bob Valamehr - Chief Development Officer Wayne Chu - Senior Vice President, Clinical Development Conference Call Participants Robyn Karnauskas - Truist Securities Kelsey Goodwin - Guggenheim Securities Daina Graybosch - SVB Leerink Mara Goldstein - Mizuho Peter Lawson - Barclays Matt Biegler - Oppenh ...
Fate Therapeutics(FATE) - 2020 Q2 - Quarterly Report
2020-08-05 20:09
I think UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading symbol(s) Name of each exchange on which registered Common Stock FATE Nasdaq Global Market FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2020 OR ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE ACT OF 1934 From the transition period from to . Commission File Number 001-36076 FATE THERA ...
Fate Therapeutics(FATE) - 2020 Q1 - Earnings Call Transcript
2020-05-12 04:38
Fate Therapeutics, Inc. (NASDAQ:FATE) Q1 2020 Earnings Conference Call May 11, 2020 5:00 PM ET Company Participants Scott Wolchko - President & Chief Executive Officer Wayne Chu - Senior Vice President, Clinical Development Conference Call Participants Ted Tenthoff - Piper Sandler Robyn Karnauskas - SunTrust Robinson Jim Birchenough - Wells Fargo Alethia Young - Cantor Daina Graybosch - SVB Leerink David Nierengarten - Wedbush Securities Biren Amin - Jefferies Mara Goldstein - Mizuho Ben Burnett - Stifel ...
Fate Therapeutics(FATE) - 2020 Q1 - Quarterly Report
2020-05-11 20:17
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading symbol(s) Name of each exchange on which registered Common Stock FATE Nasdaq Global Market FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2020 OR ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE ACT OF 1934 From the transition period from to . Commission File Number 001-36076 (Exact name of re ...
Fate Therapeutics(FATE) - 2019 Q4 - Annual Report
2020-03-02 21:04
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission file number 001-36076 FATE THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) | --- | |-------| | | | | | | | ...
Fate Therapeutics(FATE) - 2019 Q3 - Earnings Call Transcript
2019-11-06 04:17
Financial Data and Key Metrics Changes - Revenue for Q3 2019 was $2.4 million, an increase from $1 million in the same period last year, primarily derived from the iPSC-derived CAR-T cell collaboration with Ono Pharmaceutical [40] - Research and development expenses rose to $23.2 million from $13.6 million year-over-year, attributed to increased employee compensation and clinical development costs [40] - General and administrative expenses increased to $6.3 million from $4.1 million, mainly due to higher employee compensation [41] - Total operating expenses were $25 million for Q3 2019, net of approximately $4.6 million in non-cash stock-based compensation [41] - The company ended Q3 2019 with $303 million in cash, cash equivalents, and short-term investments following a $173 million common stock offering [42] Business Line Data and Key Metrics Changes - The company achieved significant milestones, including the treatment of the first patient with FT516 and FDA clearance for FT596, marking advancements in their iPSC product platform [6][7][8] - FT516 is being investigated as a monotherapy for relapsed refractory acute myeloid leukemia and in combination with CD20 directed monoclonal antibodies for B-cell lymphoma [13][15] - FT596 is designed to engage multiple tumor-associated antigens and is the first cell therapy cleared by the FDA for clinical investigation with three active anti-tumor modalities [19][20] Market Data and Key Metrics Changes - The company is positioned as a leader in the development of off-the-shelf engineered NK cell and T-cell cancer immunotherapy, with a focus on generating clinical data across multiple product candidates [6][10] - The competitive landscape includes other companies like Allogene, which are also pursuing iPSC technologies, but the company believes its platform offers unique advantages in engineering and manufacturing [45][46] Company Strategy and Development Direction - The company aims to leverage its iPSC product platform to deliver disruptive cellular immunotherapies to cancer patients, focusing on operational capabilities for consistent and cost-effective manufacturing [10][43] - There is a commitment to both NK and T-cell therapies, with ongoing exploration of combining both cell types for enhanced therapeutic effects [75][76] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the operational progress and expanding leadership position in the cellular immunotherapy space, anticipating significant clinical data generation from their product pipeline [43] - The company is optimistic about the potential of FT500 to re-sensitize patients to checkpoint inhibitor therapy and overcome disease resistance [28][27] Other Important Information - The company completed patient enrollment for the ProTmune clinical trial, which aims to prevent acute graft versus host disease, a significant achievement in their operational timeline [38][39] - The company plans to present at major conferences, including the Society for Immunotherapy of Cancer and the American Society of Hematology, showcasing their advancements and clinical data [36][37] Q&A Session Summary Question: Differentiation from Allogene's iPSC technology - Management discussed the differences in technology, emphasizing their expertise in iPSC culture and the unique aspects of their platform compared to Allogene's focus on T-cell maturation [45][46] Question: Safety and implications of FT500 - Management highlighted the positive safety profile observed in FT500 trials, noting that patients tolerated the treatment well without dose-limiting toxicities [49][50] Question: Regulatory response to increased complexity in edits - Management indicated that their platform's unique approach to gene editing provides a significant advantage in regulatory discussions, allowing for more complex edits without the challenges faced by batch-engineered therapies [52][54] Question: Updates on FT596 and ProTmune trial endpoints - Management confirmed that the primary endpoint for the ProTmune trial is the cumulative incidence of grade two through four GvHD at day 100, with discussions ongoing about secondary endpoints [63][64] Question: Efficacy expectations for FT596 - Management anticipates that FT596 will achieve efficacy levels comparable to other adoptive cell therapies while maintaining a manageable safety profile [71][72]