Fate Therapeutics(FATE)

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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 - 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]
Fate Therapeutics(FATE) - 2019 Q1 - Quarterly Report
2019-05-07 20:23
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 March 31, 2019 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) (IRS Employer Identification No.) 92121 Delaware 65-13115 ...
Fate Therapeutics(FATE) - 2018 Q4 - Earnings Call Transcript
2019-03-06 03:58
Fate Therapeutics, Inc. (NASDAQ:FATE) Q4 2018 Results Conference Call March 5, 2019 5:00 PM ET Company Participants Scott Wolchko - President and CEO Dr. Dan Shoemaker - Chief Scientific Officer Conference Call Participants Ted Tenthoff - Piper Jaffary Kripa Devarakonda - Citi Yanan Zhu - Wells Fargo Biren Amin - Jefferies Matt Biegler - Oppenheimer Reni Benjamin - Raymond James Operator Welcome to the Fate Therapeutics Fourth Quarter 2018 Financial Results Conference Call. At this time, all participants ar ...
Fate Therapeutics(FATE) - 2018 Q4 - Annual Report
2019-03-05 21:04
Part I [Business](index=5&type=section&id=Item%201.%20Business) Fate Therapeutics is a clinical-stage biopharmaceutical company developing programmed cellular immunotherapies for cancer and immune disorders [General Description and Strategy](index=5&type=section&id=General%20Description%20and%20Strategy) The company develops first-in-class cellular immunotherapies using cell programming and iPSC technology, focusing on allogeneic therapies and strategic collaborations - Fate Therapeutics is a clinical-stage biopharmaceutical company developing programmed cellular immunotherapies for cancer and immune disorders[9](index=9&type=chunk) - The company's therapeutic approach involves 'cell programming' using either pharmacologic modulators on donor cells or generating therapies from clonal master induced pluripotent stem cell (iPSC) lines[9](index=9&type=chunk)[13](index=13&type=chunk) - The business strategy focuses on developing allogeneic therapies to improve consistency and reduce costs, leveraging its **iPSC platform** for off-the-shelf products, and forming strategic partnerships to accelerate clinical translation[15](index=15&type=chunk) [Product Pipeline & Partnerships](index=6&type=section&id=Product%20Pipeline%20%26%20Partnerships) The company's pipeline includes Immuno-Oncology and Immuno-Regulation programs, featuring donor and iPSC-derived cell therapies, supported by strategic partnerships Development Pipeline Summary | Product Candidate | Cell Type | Stage of Development | Therapeutic Area | Commercial Rights | | :--- | :--- | :--- | :--- | :--- | | **Immuno-Oncology** | | | | | | FATE-NK100 | Donor NK | Phase 1 | AML, Ovarian Cancer, Solid Tumors | Worldwide | | FT500 | iPSC-NK | IND Allowed | Advanced Solid Tumors | Worldwide | | FT516 | iPSC-NK | IND Allowed | Hematologic Malignancies | Worldwide | | FT596 | iPSC-NK | Preclinical | Hematologic Malignancies | Worldwide | | FT538 | iPSC NK | Preclinical | Hematologic Malignancies | Worldwide | | FT819 | iPSC-T | Preclinical | Hematologic Malignancies | Worldwide | | **Immuno-Regulation** | | | | | | ProTmune™ | Donor cell graft | Phase 2 | Prevention of Acute GvHD | Worldwide | | FT301 | iPSC-MDSC | Preclinical | Immune Disorders | Worldwide | - **FATE-NK100** is in three Phase 1 trials for AML, ovarian cancer, and advanced solid tumors, showing some anti-leukemic activity and disease control[23](index=23&type=chunk)[26](index=26&type=chunk)[27](index=27&type=chunk) - The FDA cleared IND applications for **FT500** and **FT516**, the first iPSC-derived cell therapies to enter clinical investigation in the U.S., for solid tumors and hematologic malignancies respectively[17](index=17&type=chunk)[30](index=30&type=chunk)[34](index=34&type=chunk) - **ProTmune™** is in a randomized, controlled Phase 2 trial (PROTECT study) for preventing acute GvHD in HCT patients, with Phase 1 data showing good tolerability and no graft failure or cancer relapse[41](index=41&type=chunk)[44](index=44&type=chunk) - A key partnership with **Ono Pharmaceutical** for iPSC-derived CAR T-cell candidates involved a **$10 million** upfront payment and up to **$20 million** in R&D fees[46](index=46&type=chunk)[48](index=48&type=chunk) [Intellectual Property and License Agreements](index=18&type=section&id=Intellectual%20Property%20and%20License%20Agreements) The company's extensive IP portfolio, comprising over 300 patents and applications, is bolstered by key exclusive license agreements with academic institutions - The company's intellectual property portfolio consists of over **200 licensed** and over **100 owned** issued patents or pending applications, covering its product candidates and platform technologies[53](index=53&type=chunk) - Key IP relates to programming hematopoietic and immune cells (patents expiring **2027-2039**) and iPSC technology, including generation, engineering, and differentiation (patents expiring **2024-2038**)[56](index=56&type=chunk)[57](index=57&type=chunk)[59](index=59&type=chunk) - The company has material exclusive license agreements with several institutions, including Children's Medical Center, University of Minnesota, Memorial Sloan Kettering, Whitehead Institute, and The Scripps Research Institute, crucial for product development[61](index=61&type=chunk)[64](index=64&type=chunk)[65](index=65&type=chunk) - These license agreements obligate the company to pay annual maintenance fees, development and commercial milestones (e.g., up to **$5.0 million** per product to CMCC, **$12.5 million** per product to MSK), and royalties on net sales[61](index=61&type=chunk)[66](index=66&type=chunk) [Manufacturing, Competition, and Regulation](index=23&type=section&id=Manufacturing%2C%20Competition%2C%20and%20Regulation) The company manages manufacturing through third parties and its own GMP facility, faces intense competition, and navigates complex FDA regulations for its cell therapies - Manufacturing for **ProTmune** and **FATE-NK100** is performed at clinical cell processing facilities affiliated with trial sites[73](index=73&type=chunk)[74](index=74&type=chunk) - The manufacturing of iPSC-derived products is a three-stage process, utilizing CMOs and the company's own developing GMP facility[76](index=76&type=chunk) - The company faces significant competition from numerous large and small biopharmaceutical companies in the cellular immunotherapy space, including Allogene, Atara, bluebird bio, Celgene, Gilead, and Novartis[96](index=96&type=chunk) - Biological products are regulated by the FDA under the FDCA and PHS Act, requiring rigorous nonclinical testing, an effective IND, well-controlled clinical trials, and an approved Biologics License Application (BLA)[78](index=78&type=chunk)[80](index=80&type=chunk)[81](index=81&type=chunk) - The FDA offers expedited programs such as Fast Track, priority review, accelerated approval, and breakthrough therapy designation, with **ProTmune** having received Fast Track designation[88](index=88&type=chunk)[44](index=44&type=chunk) [Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks including clinical trial failures, manufacturing complexities, funding needs, intense competition, and intellectual property and commercialization challenges - **Development & Regulatory Risks:** The company may face delays or failures in clinical trials due to difficulties in patient enrollment, unexpected safety issues, or regulatory hurdles for its novel cell therapies, potentially requiring additional unanticipated studies[105](index=105&type=chunk)[108](index=108&type=chunk)[113](index=113&type=chunk) - **Manufacturing & Supply Risks:** Manufacturing of cell therapies, particularly iPSC-derived products, is complex, costly, and subject to risks of failure or inconsistency, with reliance on third-party manufacturers and suppliers for critical materials[117](index=117&type=chunk)[120](index=120&type=chunk)[140](index=140&type=chunk) - **Financial & Operational Risks:** The company has a history of losses and will require substantial additional funding to complete development and commercialization, facing intense competition from better-funded companies and reliance on key personnel[109](index=109&type=chunk)[178](index=178&type=chunk)[191](index=191&type=chunk) - **Third-Party & IP Risks:** The business depends on strategic collaborations (e.g., Ono, Juno), and their failure could harm product development; the company must also obtain, maintain, and defend its intellectual property rights and could face infringement claims[136](index=136&type=chunk)[147](index=147&type=chunk)[152](index=152&type=chunk) - **Commercialization Risks:** The commercial success of its products depends on market acceptance by physicians and payers, favorable pricing, and adequate reimbursement, all of which are uncertain for novel cell therapies[164](index=164&type=chunk)[165](index=165&type=chunk)[167](index=167&type=chunk) [Properties](index=55&type=section&id=Item%202.%20Properties) The company leases approximately **48,000 square feet** of office and laboratory space in San Diego, California, with an additional **24,000 square feet** leased in January 2019 - The company leases approximately **48,000 square feet** of office and laboratory space in San Diego, CA under a lease through December 2028[207](index=207&type=chunk) - In January 2019, the company expanded its leased space by an additional **24,000 square feet**[207](index=207&type=chunk) [Legal Proceedings](index=56&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings and does not anticipate any significant adverse effects from potential future claims - As of the report date, the company is not a party to any material legal proceedings[209](index=209&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=57&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on NASDAQ under 'FATE', has never paid dividends, and made no share repurchases in 2018 - The company's common stock is traded on The NASDAQ Global Market under the ticker symbol "**FATE**"[213](index=213&type=chunk) - The company has never paid dividends and does not plan to in the foreseeable future[217](index=217&type=chunk) - No equity securities were repurchased by the company in the year ended December 31, 2018[220](index=220&type=chunk) [Selected Financial Data](index=58&type=section&id=Item%206.%20Selected%20Financial%20Data) In 2018, the company reported **$4.7 million** in revenue and a **$66.6 million** net loss, with total assets increasing to **$213.0 million** Selected Consolidated Financial Data (in thousands, except per share data) | Metric | 2018 | 2017 | | :--- | :--- | :--- | | Collaboration Revenue | $4,740 | $4,106 | | Research and development | $56,024 | $34,358 | | General and administrative | $15,808 | $11,873 | | Loss from operations | $(67,092) | $(42,125) | | Net loss | $(66,598) | $(42,952) | | Net loss per common share | $(1.19) | $(1.02) | | **Balance Sheet Data** | | | | Cash and cash equivalents | $190,514 | $88,952 | | Total assets | $213,032 | $105,292 | | Total stockholders' equity | $160,469 | $77,189 | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=59&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company's 2018 net loss increased to **$66.6 million** due to higher R&D and G&A expenses, while liquidity improved to **$201.0 million** from a public offering [Results of Operations](index=70&type=section&id=Results%20of%20Operations) In 2018, collaboration revenue slightly increased to **$4.7 million**, while R&D expenses surged by **$21.7 million** and G&A expenses by **$3.9 million** Comparison of Operations (Years Ended Dec 31, in thousands) | Item | 2018 | 2017 | Change | | :--- | :--- | :--- | :--- | | Collaboration revenue | $4,740 | $4,106 | $634 | | Research and development expenses | $56,024 | $34,358 | $21,666 | | General and administrative expenses | $15,808 | $11,873 | $3,935 | - The **$21.7 million** increase in R&D expenses in 2018 was driven by higher costs for third-party services (**$7.8 million**), licensing (**$6.7 million**), employee compensation (**$4.3 million**), and lab supplies (**$2.5 million**)[250](index=250&type=chunk) - The **$3.9 million** increase in G&A expenses in 2018 was mainly due to higher employee compensation (**$2.2 million**) and increased advisory and consulting fees (**$1.3 million**)[250](index=250&type=chunk) [Liquidity and Capital Resources](index=71&type=section&id=Liquidity%20and%20Capital%20Resources) As of December 31, 2018, the company held **$201.0 million** in cash and investments, significantly bolstered by **$140.8 million** from financing activities, primarily a public stock offering Summary of Cash Flow Activity (in thousands) | Activity | 2018 | 2017 | | :--- | :--- | :--- | | Net cash used in operating activities | $(38,650) | $(36,817) | | Net cash used in investing activities | $(463) | $(10,196) | | Net cash provided by financing activities | $140,780 | $47,356 | - As of December 31, 2018, the company had **$201.0 million** in cash, cash equivalents, and short-term investments[263](index=263&type=chunk) - In September 2018, the company raised net proceeds of **$134.9 million** from a public offering of common stock[265](index=265&type=chunk) - The company believes its existing cash and investments are sufficient to fund projected operating requirements for at least the next twelve months[275](index=275&type=chunk) [Contractual Obligations](index=72&type=section&id=Contractual%20Obligations) As of December 31, 2018, total contractual obligations were **$59.7 million**, comprising **$18.5 million** in debt and **$41.2 million** in operating lease obligations Contractual Obligations at December 31, 2018 (in thousands) | Obligation | Total | Less than 1 Year | 1 - 3 Years | 3 - 5 Years | More than 5 Years | | :--- | :--- | :--- | :--- | :--- | :--- | | Long-term debt (including interest and fees) | $18,480 | $3,720 | $13,131 | $1,629 | $— | | Operating lease obligations | $41,221 | $3,019 | $7,634 | $8,098 | $22,470 | | **Total** | **$59,701** | **$6,739** | **$20,765** | **$9,727** | **$22,470** | - The company has additional obligations for potential milestone payments and royalties under its license agreements, which are not quantified due to uncertainty of timing and occurrence[277](index=277&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=73&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate sensitivity on its cash and investments, with a **10%** rate change not expected to materially impact financial results - The company's primary market risk is interest rate sensitivity on its cash, cash equivalents, and short-term investments[281](index=281&type=chunk) - Due to the short-term nature of its investments and the capped interest rate on its debt, a **10%** change in market interest rates is not expected to materially impact financial results[281](index=281&type=chunk) [Financial Statements and Supplementary Data](index=74&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) The 2018 consolidated financial statements show total assets of **$213.0 million**, a net loss of **$66.6 million**, and **$190.5 million** in cash, reflecting increased R&D and G&A spending [Consolidated Balance Sheets](index=75&type=section&id=Consolidated%20Balance%20Sheets) As of December 31, 2018, total assets reached **$213.0 million**, driven by increased cash to **$190.5 million**, with total liabilities at **$52.6 million** and equity at **$160.5 million** Consolidated Balance Sheet Highlights (in thousands) | Account | Dec 31, 2018 | Dec 31, 2017 | | :--- | :--- | :--- | | Cash and cash equivalents | $190,514 | $88,952 | | Total current assets | $205,196 | $102,596 | | Total assets | $213,032 | $105,292 | | Total current liabilities | $27,263 | $11,049 | | Total liabilities | $52,563 | $28,103 | | Total stockholders' equity | $160,469 | $77,189 | [Consolidated Statements of Operations](index=76&type=section&id=Consolidated%20Statements%20of%20Operations) For 2018, the company reported a net loss of **$66.6 million** on **$4.7 million** in revenue, an increased loss primarily due to higher operating expenses Consolidated Statement of Operations Highlights (in thousands) | Account | 2018 | 2017 | 2016 | | :--- | :--- | :--- | :--- | | Collaboration revenue | $4,740 | $4,106 | $4,402 | | Research and development | $56,024 | $34,358 | $26,452 | | General and administrative | $15,808 | $11,873 | $9,913 | | Loss from operations | $(67,092) | $(42,125) | $(31,963) | | Net loss | $(66,598) | $(42,952) | $(33,462) | | Net loss per share | $(1.19) | $(1.02) | $(1.05) | [Consolidated Statements of Cash Flows](index=78&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) In 2018, net cash used in operations was **$38.7 million**, offset by **$140.8 million** from financing activities, resulting in a **$101.7 million** increase in cash Consolidated Statement of Cash Flows Highlights (in thousands) | Cash Flow | 2018 | 2017 | | :--- | :--- | :--- | | Net cash used in operating activities | $(38,650) | $(36,817) | | Net cash used in investing activities | $(463) | $(10,196) | | Net cash provided by financing activities | $140,780 | $47,356 | | Net increase in cash, cash equivalents and restricted cash | $101,667 | $343 | [Controls and Procedures](index=102&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and internal control over financial reporting were effective as of December 31, 2018, affirmed by an unqualified audit opinion - Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2018[399](index=399&type=chunk) - Management concluded that the company's internal control over financial reporting was effective as of December 31, 2018, a conclusion audited and supported by an unqualified opinion from Ernst & Young LLP[399](index=399&type=chunk)[402](index=402&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=105&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information on directors, executive officers, and corporate governance is incorporated by reference from the company's definitive proxy statement - The information required by this item is incorporated by reference from the registrant's definitive proxy statement to be filed with the SEC[409](index=409&type=chunk) [Executive Compensation](index=105&type=section&id=Item%2011.%20Executive%20Compensation) Information regarding executive compensation is incorporated by reference from the company's definitive proxy statement - The information required by this item is incorporated by reference from the registrant's definitive proxy statement[410](index=410&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=105&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information regarding security ownership of certain beneficial owners and management is incorporated by reference from the company's definitive proxy statement - The information required by this item is incorporated by reference from the registrant's definitive proxy statement[411](index=411&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=105&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information regarding certain relationships, related party transactions, and director independence is incorporated by reference from the company's definitive proxy statement - The information required by this item is incorporated by reference from the registrant's definitive proxy statement[412](index=412&type=chunk) [Principal Accounting Fees and Services](index=105&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Information regarding principal accounting fees and services is incorporated by reference from the company's definitive proxy statement - The information required by this item is incorporated by reference from the registrant's definitive proxy statement[413](index=413&type=chunk) Part IV [Exhibits and Financial Statement Schedules](index=106&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists the financial statements, schedules, and exhibits filed as part of the Annual Report on Form 10-K, with financial statements starting on page 74 - This section contains the index to the company's financial statements and a list of all exhibits filed with the report[416](index=416&type=chunk)[417](index=417&type=chunk)