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Fate Therapeutics(FATE) - 2021 Q4 - Earnings Call Transcript
2022-03-01 04:01
Fate Therapeutics, Inc. (NASDAQ:FATE) Q4 2021 Earnings Conference Call February 28, 2022 5:00 PM ET Company Participants Scott Wolchko - President and Chief Executive Officer Wayne Chu - Chief Medical Officer Ed Dulac - Chief Financial Officer Bob Valamehr - Chief Research and Development Officer Conference Call Participants Michael Yee - Jefferies Ashiq Mubarack - Citi Daina Graybosch - SVB Leerink Kelsey Goodwin - Guggenheim Nick Abbott - Wells Fargo Matt Biegler - Oppenheimer Robyn Karnauskas - Truist Se ...
Fate Therapeutics(FATE) - 2021 Q4 - Annual Report
2022-02-27 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, 2021 ☐ 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) - 2021 Q3 - Earnings Call Transcript
2021-11-05 04:29
Fate Therapeutics, Inc. (NASDAQ:FATE) Q3 2021 Earnings Conference Call November 4, 2021 5:00 PM ET Company Participants Scott Wolchko - President and CEO Ed Dulac - CFO Wayne Chu - SVP, Clinical development Conference Call Participants Michael Yee - Jefferies Mike Ulz - Morgan Stanley Alethia Young - Cantor Peter Lawson - Barclays Daina Graybosch - SVB Srikripa Devarakonda - Truist Securities Matt Biegler - Oppenheimer Mara Goldstein - Mizuho Nick Abbott - Wells Fargo Ted Tenthoff - Piper Sandler Rob Burns ...
Fate Therapeutics(FATE) - 2021 Q3 - Quarterly Report
2021-11-03 16:00
[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Condensed Consolidated Financial Statements (unaudited)](index=4&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) The unaudited financial statements for Q3 2021 show increased assets and collaboration revenue, but also a wider net loss due to higher operating expenses [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets increased to **$984.6 million** by September 30, 2021, driven by financing activities, nearly doubling stockholders' equity Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | Sep 30, 2021 (unaudited) | Dec 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $129,180 | $167,347 | | Short-term & Long-term investments | $674,398 | $315,569 | | Total assets | $984,571 | $622,457 | | **Liabilities & Equity** | | | | Total liabilities | $254,239 | $238,012 | | Total stockholders' equity | $730,332 | $384,445 | | Total liabilities and stockholders' equity | $984,571 | $622,457 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Q3 2021 saw collaboration revenue rise to **$14.2 million** and a reduced net loss, while the nine-month period showed higher revenue but a wider net loss of **$143.5 million** Statement of Operations Summary (in thousands, except per share data) | Metric | Q3 2021 | Q3 2020 | Nine Months 2021 | Nine Months 2020 | | :--- | :--- | :--- | :--- | :--- | | Collaboration revenue | $14,225 | $7,558 | $38,777 | $15,538 | | Research and development | $53,130 | $30,694 | $146,004 | $86,641 | | General and administrative | $15,718 | $8,351 | $40,385 | $23,583 | | Loss from operations | ($54,623) | ($31,487) | ($147,612) | ($94,686) | | Net loss | ($43,308) | ($58,684) | ($143,530) | ($120,276) | | Net loss per common share | ($0.45) | ($0.68) | ($1.52) | ($1.49) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations significantly increased to **$92.6 million** for the nine months, offset by **$449.7 million** from financing activities, primarily a public offering Cash Flow Summary for the Nine Months Ended Sep 30 (in thousands) | Cash Flow Activity | 2021 (unaudited) | 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | ($92,577) | ($18,565) | | Net cash provided by (used in) investing activities | ($395,301) | $4,953 | | Net cash provided by financing activities | $449,711 | $277,928 | | **Net change in cash, cash equivalents and restricted cash** | **($38,167)** | **$264,316** | [Notes to Condensed Consolidated Financial Statements (unaudited)](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) Notes detail accounting policies, collaboration revenues, MSK license terms with stock-price-contingent payments, and **$432.4 million** net proceeds from a January 2021 public offering - The company is a clinical-stage biopharmaceutical firm focused on developing off-the-shelf natural killer (NK) and T-cell product candidates from clonal master engineered induced pluripotent stem cell (iPSC) lines[22](index=22&type=chunk) - The company's revenues to date have been derived from collaboration agreements and government grants, with no revenue from therapeutic product sales[23](index=23&type=chunk) - In January 2021, the company raised net proceeds of **$432.4 million** from a public offering of common stock and pre-funded warrants[24](index=24&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses iPSC platform development, increased collaboration revenue and operating expenses, and strong liquidity of **$803.6 million** from a public offering - The company is a clinical-stage biopharmaceutical company developing off-the-shelf NK and T-cell product candidates derived from clonal master iPSC lines for cancer treatment[129](index=129&type=chunk)[130](index=130&type=chunk) - Key strategic collaborations for developing and commercializing iPSC-derived CAR NK- and CAR T-cell product candidates are in place with Janssen and Ono Pharmaceutical[132](index=132&type=chunk)[133](index=133&type=chunk) - The company expects expenses to increase substantially due to ongoing and planned clinical trials, GMP production activities, and establishing operations at its new corporate headquarters[135](index=135&type=chunk)[137](index=137&type=chunk) - The COVID-19 pandemic has caused some delays and disruptions in clinical trials and research activities, with the ultimate impact remaining unknown[139](index=139&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) Q3 2021 saw collaboration revenue increase to **$14.2 million**, with R&D and G&A expenses rising significantly, leading to a wider operating loss for the nine-month period Comparison of Operating Results (in millions) | Period | Metric | 2021 | 2020 | Change | | :--- | :--- | :--- | :--- | :--- | | **Q3** | Collaboration Revenue | $14.2 | $7.6 | +$6.6 | | | R&D Expense | $53.1 | $30.7 | +$22.4 | | | G&A Expense | $15.7 | $8.4 | +$7.3 | | **Nine Months** | Collaboration Revenue | $38.8 | $15.5 | +$23.3 | | | R&D Expense | $146.0 | $86.6 | +$59.4 | | | G&A Expense | $40.4 | $23.6 | +$16.8 | - The primary drivers for increased R&D expenses were higher employee compensation (including stock-based compensation), increased third-party consultant and clinical trial costs, and greater expenditures for laboratory materials and supplies[163](index=163&type=chunk)[164](index=164&type=chunk)[165](index=165&type=chunk) - Other income for Q3 2021 was **$11.3 million**, compared to an expense of **($27.2) million** in Q3 2020, primarily due to a positive change in the fair value of stock price appreciation milestones related to the Amended MSK License[166](index=166&type=chunk) [Liquidity and Capital Resources](index=32&type=section&id=Liquidity%20and%20Capital%20Resources) The company maintains strong liquidity with **$803.6 million** in cash and investments, bolstered by **$449.7 million** from financing activities, including a public offering - The company held **$803.6 million** in cash, cash equivalents, and investments as of September 30, 2021[184](index=184&type=chunk) - Financing activities in the first nine months of 2021 provided **$449.7 million**, mainly from the January 2021 public offering which yielded net proceeds of **$432.4 million**[181](index=181&type=chunk)[186](index=186&type=chunk) - In July 2021, the company achieved a clinical milestone under the Amended MSK License, triggering a **$20.0 million** payment obligation to MSK, which was recorded as a current liability[179](index=179&type=chunk)[198](index=198&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=37&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Primary market risks include low interest rate risk and significant stock price sensitivity due to MSK license milestone payments contingent on stock performance - Interest rate risk is low due to the low-risk profile of the company's investment portfolio[201](index=201&type=chunk) - The company has significant market risk related to its own stock price due to the MSK license agreement, which has milestone payments contingent on stock price appreciation. As of September 30, 2021, the estimated fair value of the remaining milestone liability was **$24.6 million**, in addition to a **$20.0 million** payment already triggered[202](index=202&type=chunk) [Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of September 30, 2021, with no material changes in internal control - The Principal Executive Officer and Principal Financial Officer concluded that the company's disclosure controls and procedures were effective as of September 30, 2021[205](index=205&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, these controls[206](index=206&type=chunk) [PART II. OTHER INFORMATION](index=39&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=39&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings, with no expected material adverse effects from ordinary course claims - As of the filing date, the company is not a party to any material legal proceedings[208](index=208&type=chunk) [Risk Factors](index=39&type=section&id=Item%201A.%20Risk%20Factors) Significant risks include unproven iPSC/gene-editing technologies, manufacturing complexities, clinical trial delays, reliance on third parties, IP protection, and commercialization uncertainties [Risks Related to Discovery, Development, and Regulation](index=40&type=section&id=Risks%20Related%20to%20the%20Discovery%2C%20Development%20and%20Regulation%20of%20Our%20Product%20Candidates) Risks include the unproven nature of iPSC/gene-editing technologies, manufacturing complexities, clinical trial delays, and an uncertain regulatory pathway for novel therapies - Product candidates represent a novel therapeutic approach using iPSC and gene-editing technologies, which are unproven and make it difficult to predict development time, cost, and regulatory approval success[212](index=212&type=chunk)[213](index=213&type=chunk)[257](index=257&type=chunk) - The company may face delays in initiating or completing clinical trials due to challenges in patient enrollment, which could be exacerbated by the COVID-19 pandemic[214](index=214&type=chunk)[236](index=236&type=chunk) - The manufacture and distribution of iPSC-derived cell product candidates are complex, subject to a multitude of risks, and could be delayed or restricted by additional FDA requirements[216](index=216&type=chunk)[242](index=242&type=chunk) [Risks Related to Reliance on Third Parties](index=54&type=section&id=Risks%20Related%20to%20Our%20Reliance%20on%20Third%20Parties) High dependence on third-party CMOs, sole-source suppliers, and strategic partners like Janssen and Ono poses risks of delays and financial harm - Reliance on third-party CMOs for manufacturing entails risks related to regulatory compliance, quality assurance, and potential termination of services, which could disrupt supply for clinical trials[298](index=298&type=chunk)[300](index=300&type=chunk) - The company relies on third-party suppliers, including sole-source suppliers, for essential reagents, materials, and equipment, making it vulnerable to supply chain disruptions[302](index=302&type=chunk)[309](index=309&type=chunk) - The company depends on strategic partnerships, such as those with Janssen and Ono, for the development and commercialization of certain product candidates. Unsuccessful collaborations could materially harm results[221](index=221&type=chunk)[303](index=303&type=chunk) [Risks Related to Intellectual Property](index=57&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) Success hinges on obtaining and maintaining patent protection, facing risks of uncertain patent scope, infringement, and loss of rights under license agreements - The company's commercial success depends on obtaining and maintaining patent protection for its technology and product candidates, which is uncertain in the complex and evolving field of biotechnology[223](index=223&type=chunk)[323](index=323&type=chunk) - Failure to comply with obligations under license agreements, such as the one with MSK which includes significant stock-price contingent payments, could result in the loss of rights to key technologies[223](index=223&type=chunk)[327](index=327&type=chunk) - The company may face litigation for infringing on the intellectual property rights of others, which could be costly and prevent or delay product development and commercialization[333](index=333&type=chunk) [Risks Related to Commercialization](index=63&type=section&id=Risks%20Related%20to%20the%20Commercialization%20of%20Our%20Product%20Candidates) Commercialization risks include lack of marketing experience, uncertain market acceptance, challenges in pricing and reimbursement, and potential negative impacts from healthcare reform - The company has no experience in marketing, sales, or distribution, and its ability to successfully commercialize approved products is unproven[224](index=224&type=chunk)[357](index=357&type=chunk) - Commercial success is dependent on market acceptance by physicians, patients, and third-party payers, which is uncertain for novel cell therapies[225](index=225&type=chunk)[359](index=359&type=chunk) - Failure to obtain or maintain adequate insurance coverage and reimbursement for product candidates from government and private payors could severely limit product revenues[363](index=363&type=chunk)[364](index=364&type=chunk) [Risks Related to Business and Industry](index=65&type=section&id=Risks%20Related%20to%20Our%20Business%20and%20Industry) Business risks include reliance on evolving cellular immunotherapy, intense competition, loss of key personnel, growth management challenges, COVID-19 disruptions, and operational liabilities - The success of the company's product candidates is highly dependent on developments in the novel field of cellular immunotherapy, particularly those using pluripotent or genome-edited cells[225](index=225&type=chunk)[378](index=378&type=chunk) - The company faces intense competition from other biotechnology and pharmaceutical companies that may have greater financial and operational resources[225](index=225&type=chunk)[381](index=381&type=chunk) - The ongoing COVID-19 pandemic could adversely impact business operations, including research, manufacturing, clinical trial conduct, and financial condition[219](index=219&type=chunk)[386](index=386&type=chunk) [Risks Related to Financial Condition and Stock Ownership](index=71&type=section&id=Risks%20Related%20to%20Our%20Financial%20Condition%20and%20the%20Ownership%20of%20Our%20Common%20Stock) Financial risks include a history of losses, need for additional funding, stock price volatility, significant control by principal stockholders, and potential future dilution - The company has a limited operating history with significant losses (**$700.5 million** accumulated deficit as of Sep 30, 2021) and anticipates continued losses, requiring substantial additional funding for development[232](index=232&type=chunk)[414](index=414&type=chunk)[421](index=421&type=chunk) - The company's stock price is subject to high volatility and may trigger financial obligations, such as the milestone payments to MSK which are contingent on stock price increases[424](index=424&type=chunk)[426](index=426&type=chunk) - Executive officers, directors, and 5% stockholders beneficially own approximately **42.0%** of the company's voting stock, enabling them to exercise significant control over corporate matters[226](index=226&type=chunk)[427](index=427&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=78&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities were reported during the period - There were no unregistered sales of equity securities in the reported period[460](index=460&type=chunk) [Defaults Upon Senior Securities](index=78&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities were reported - None[461](index=461&type=chunk) [Mine Safety Disclosures](index=78&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[462](index=462&type=chunk) [Other Information](index=78&type=section&id=Item%205.%20Other%20Information) No other information was reported for this item - None[463](index=463&type=chunk) [Exhibits](index=79&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with Form 10-Q, including corporate documents and officer certifications - Lists various corporate documents and certifications filed as exhibits, including CEO and CFO certifications pursuant to the Sarbanes-Oxley Act[465](index=465&type=chunk)
Fate Therapeutics(FATE) - 2021 Q2 - Earnings Call Transcript
2021-08-05 03:25
Fate Therapeutics, Inc. (NASDAQ:FATE) Q2 2021 Earnings Conference Call August 4, 2021 5:00 PM ET Company Participants Scott Wolchko - President and CEO Ed Dulac - CFO Conference Call Participants Yigal Nochomovitz - Citi Michael Schmidt - Guggenheim Alethia Young - Cantor Fitzgerald Michael Yee - Jefferies Daina Graybosch - SVB Leerink Ben Burnett - Stifel Peter Lawson - Barclays Matt Biegler - Oppenheimer Mara Goldstein - Mizuho Srikripa Devarakonda - Truist Securities Nick Abbott - Wells Fargo Operator We ...
Fate Therapeutics(FATE) - 2021 Q2 - Quarterly Report
2021-08-03 16:00
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, 2021 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 nam ...
Fate Therapeutics(FATE) - 2021 Q1 - Earnings Call Transcript
2021-05-06 03:39
Fate Therapeutics, Inc. (NASDAQ:FATE) Q1 2021 Earnings Conference Call May 5, 2021 5:00 PM ET Company Participants Scott Wolchko - President and Chief Executive Officer Wayne Chu - Senior Vice President, Clinical development Ed Dulac - Chief Financial Officer Bob Valamehr - Chief Research and Development Officer Conference Call Participants Robyn Karnauskas - Truist Securities Ted Tenthoff - Piper Sandler Alethia Young - Cantor Yigal Nochomovitz - Citi Michael Yee - Jefferies Peter Lawson - Barclays Tazeen ...
Fate Therapeutics(FATE) - 2021 Q1 - Quarterly Report
2021-05-04 16:00
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 March 31, 2021 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 na ...
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 ...