Fate Therapeutics(FATE) - 2019 Q1 - Quarterly Report

PART I. FINANCIAL INFORMATION Condensed Consolidated Financial Statements (unaudited) This section presents the company's unaudited condensed consolidated financial statements, including balance sheets, statements of operations, cash flows, and detailed notes on accounting policies, agreements, debt, and equity Condensed Consolidated Balance Sheets The balance sheets show increased total assets and liabilities, with decreased stockholders' equity due to an accumulated deficit Condensed Consolidated Balance Sheets (in thousands) | Metric | March 31, 2019 (in thousands) | December 31, 2018 (in thousands) | | :---------------------------------- | :------------------------------ | :------------------------------- | | Total Assets | $220,865 | $213,032 | | Total Current Assets | $186,430 | $205,196 | | Cash and Cash Equivalents | $183,033 | $190,514 | | Total Current Liabilities | $29,140 | $27,263 | | Total Stockholders' Equity | $145,837 | $160,469 | | Accumulated Deficit | $(305,156) | $(285,396) | Condensed Consolidated Statements of Operations and Comprehensive Loss Increased collaboration revenue was offset by higher R&D and G&A expenses, resulting in an increased net loss for the period Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands) | Metric | Three Months Ended March 31, 2019 (in thousands) | Three Months Ended March 31, 2018 (in thousands) | Change (YoY) (in thousands) | | :-------------------------------------------------- | :----------------------------------------------- | :----------------------------------------------- | :-------------------------- | | Collaboration Revenue | $2,632 | $1,026 | $1,606 | | Research and Development Expenses | $17,728 | $11,476 | $6,252 | | General and Administrative Expenses | $5,350 | $3,604 | $1,746 | | Loss from Operations | $(20,446) | $(14,054) | $(6,392) | | Net Loss | $(19,760) | $(14,135) | $(5,625) | | Net Loss per Common Share, Basic and Diluted | $(0.30) | $(0.27) | $(0.03) | Condensed Consolidated Statements of Cash Flows Operating cash usage increased due to higher net loss, but investing activities provided cash, leading to a smaller net decrease in cash and equivalents Condensed Consolidated Statements of Cash Flows (in thousands) | Metric | Three Months Ended March 31, 2019 (in thousands) | Three Months Ended March 31, 2018 (in thousands) | | :-------------------------------------- | :----------------------------------------------- | :----------------------------------------------- | | Net Cash Used in Operating Activities | $(17,493) | $(12,551) | | Net Cash Provided by (Used in) Investing Activities | $8,754 | $(43,844) | | Net Cash Provided by Financing Activities | $1,258 | $355 | | Net Change in Cash, Cash Equivalents and Restricted Cash | $(7,481) | $(56,040) | | Cash, Cash Equivalents and Restricted Cash at End of Period | $183,260 | $33,034 | Notes to Condensed Consolidated Financial Statements These notes detail the company's financial statements, covering organization, accounting policies, collaboration agreements, debt, equity, and recent accounting pronouncements 1. Organization and Summary of Significant Accounting Policies Fate Therapeutics is a clinical-stage biopharmaceutical company focused on cellular immunotherapies, with revenue from collaborations and grants, and key accounting policies including lease accounting adoption - Fate Therapeutics, Inc. is a clinical-stage biopharmaceutical company dedicated to developing programmed cellular immunotherapies for cancer and immune disorders, with principal operations in San Diego, California[21] - The company has not generated any revenues from sales of its therapeutic products to date; revenues are derived from collaboration agreements and government grants[21] - The company adopted ASU 2016-02 (Leases) effective January 1, 2019, resulting in a $16.6 million increase in operating right-of-use assets and an $18.2 million increase in total liabilities on the unaudited condensed consolidated balance sheet[43] 2. Collaboration and License Agreements Significant collaboration and license agreements include the Ono Agreement for iPSC-derived CAR T-cell candidates, the concluded Juno Agreement, and intellectual property deals with MSK and Gladstone - Ono Agreement: Received an upfront, non-refundable payment of $10.0 million and expects $20.0 million in aggregate R&D fees over four years for joint development of two off-the-shelf iPSC-derived CAR T-cell product candidates[47] - Ono Agreement: Eligible to receive up to $285.0 million in milestone payments for Candidate 1 and up to $895.0 million for Candidate 2, plus tiered royalties[47] - Juno Agreement: The four-year initial research term concluded on May 4, 2019, with $1.0 million in collaboration revenue recognized for both the three months ended March 31, 2019 and 2018[50] - Amended MSK License: Granted additional licenses for CAR constructs and off-the-shelf CAR T cells, issued 500,000 common shares (valued at $4.8 million), and paid an upfront fee of $0.5 million[52][54] - Gladstone License Agreement: Granted exclusive licenses for iPSC-derived human therapeutics using the CRISPRa system, issued 100,000 common shares (valued at $1.3 million), and paid an upfront fee of $0.1 million[56] 3. California Institute for Regenerative Medicine Award A $4.0 million CIRM award for FT516 is suspended pending IND submission, with options for loan repayment or grant with royalties - CIRM awarded $4.0 million to advance the FT516 product candidate into a first-in-human clinical trial; $3.5 million has been received as of March 31, 2019[57] - The award is suspended until the company submits an IND application for FT516 in advanced solid tumors, with $0.5 million still available for funding[57] - The company has the option to treat the award as a loan (repayment rates from 60% to 100% plus interest) or a grant (royalty payments up to nine times the total awarded amount)[57] 4. Investments The company invests excess cash in short-term U.S. treasuries, but held no investments as of March 31, 2019, a change from prior year - The company did not have any investments as of March 31, 2019[60] Investments (in thousands) | Investment Type | Maturity (in years) | Amortized Cost (in thousands) | Unrealized Losses (in thousands) | Unrealized Gains (in thousands) | Estimated Fair Value (in thousands) | | :---------------------- | :------------------ | :---------------------------- | :------------------------------- | :------------------------------ | :---------------------------------- | | U.S. Treasury debt securities | 1 or less | $10,495 | $(2) | $0 | $10,493 | 5. Fair Value Measurements Financial assets are measured at fair value using a three-tier hierarchy, with all cash equivalents classified as Level 1 as of March 31, 2019 Fair Value Measurements (in thousands) | Asset Type | March 31, 2019 (in thousands) | December 31, 2018 (in thousands) | Fair Value Hierarchy Level | | :---------------------- | :---------------------------- | :------------------------------- | :------------------------- | | Cash equivalents | $183,033 | $190,514 | Level 1 | | U.S. Treasury debt securities | $0 | $10,493 | Level 1 | 6. Accrued Expenses and Long-Term Debt Long-term debt primarily consists of a term loan from Silicon Valley Bank, maturing in 2022, alongside various current accrued expenses including payroll and clinical trial costs Long-term Debt (in thousands) | Metric | March 31, 2019 (in thousands) | December 31, 2018 (in thousands) | | :-------------------------------------------------- | :------------------------------ | :------------------------------- | | Long-term debt (gross) | $15,000 | $15,000 | | Long-term debt, net of current portion | $10,958 | $12,446 | | Current portion of long-term debt, net | $3,941 | $2,438 | Accrued Expenses (in thousands) | Accrued Expense Type | March 31, 2019 (in thousands) | December 31, 2018 (in thousands) | | :---------------------------------- | :------------------------------ | :------------------------------- | | Accrued payroll and other employee benefits | $1,901 | $2,938 | | Accrued clinical trial related costs | $4,462 | $4,729 | | Accrued other | $3,587 | $3,259 | | Total Current Accrued Expenses | $9,950 | $10,926 | - The $15.0 million 2017 Term Loan from Silicon Valley Bank matures on January 1, 2022, and bears interest at 8.25% as of March 31, 2019[74] - The interest-only period for the 2017 Term Loan was extended from January 1, 2019, through July 31, 2019, following the achievement of a product development milestone[74] 7. Leases The company leases office and laboratory space under an operating lease extended through 2028, with ASC 842 adoption increasing right-of-use assets and lease liabilities - The operating lease for office and laboratory space was amended in May 2018, extending the term through 2028 and adding additional space, resulting in a $7.7 million increase in operating right-of-use assets and a $9.6 million increase in aggregate lease liability in Q1 2019[76] - Future minimum payments under the non-cancelable operating lease total $40.6 million over a remaining term of 9.8 years, with a discount rate of 8.0%[78] Operating Lease Payments (in thousands) | Year | Operating Lease Payments (in thousands) | | :---------------------- | :------------------------------------ | | Remaining in 2019 | $2,422 | | 2020 | $3,761 | | 2021 | $3,873 | | 2022 | $3,989 | | 2023 | $4,109 | | 2024 | $4,232 | | Thereafter | $18,238 | | Total Undiscounted Lease Payments | $40,624 | | Less imputed interest | $(12,907) | | Total Lease Liability | $27,717 | 8. Convertible Preferred Stock and Stockholders' Equity This section details Class A Convertible Preferred Stock terms, stock option and RSU activity, and stock-based compensation expense allocation - In November 2016, the company issued 2,819,549 shares of non-voting Class A Convertible Preferred Stock, each convertible into five shares of common stock[79] - Stockholders approved the issuance of up to 14,097,745 shares of common stock upon conversion of outstanding Class A Preferred Stock in May 2017, allowing Redmile to increase its ownership percentage[79] Stock Option Activity | Metric | Number of Options | Weighted Average Price ($) | | :------------------------- | :---------------- | :------------------------- | | Balance at December 31, 2018 | 6,980,581 | $5.58 | | Granted | 2,693,160 | $16.32 | | Cancelled | (228,528) | $10.25 | | Exercised | (420,920) | $3.02 | | Balance at March 31, 2019 | 9,024,293 | $8.79 | Stock-Based Compensation Expense (in thousands) | Expense Type | Three Months Ended March 31, 2019 (in thousands) | Three Months Ended March 31, 2018 (in thousands) | | :------------------------- | :----------------------------------------------- | :----------------------------------------------- | | Research and development | $2,183 | $1,382 | | General and administrative | $1,685 | $0 | | Total | $3,868 | $1,382 | Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses financial performance, liquidity, and capital resources, emphasizing the company's cellular immunotherapy focus and R&D investments driving continued net losses Overview Fate Therapeutics is a clinical-stage biopharmaceutical company developing cellular immunotherapies, incurring significant net losses since inception due to extensive R&D - Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing programmed cellular immunotherapies for cancer and immune disorders, utilizing cell programming and iPSC technology[88] - The company has never been profitable and has incurred net losses in each year since inception, with an accumulated deficit of $305.2 million as of March 31, 2019[89][109] - The company expects to continue incurring operating losses for the foreseeable future due to ongoing and planned clinical trials (ProTmune, FATE-NK100, FT500, FT516), GMP manufacturing, preclinical research, and intellectual property maintenance[89][91] Financial Operations Overview This section outlines revenue from collaborations and grants, details increased R&D and G&A expenses, and discusses critical accounting policies and estimates Collaboration Revenue Revenue is solely from collaboration agreements and government grants, with specific amounts recognized from the Ono and Juno Agreements in Q1 2019 - Revenues are derived from collaboration agreements and government grants, with no therapeutic product sales to date[93] - Recognized $1.6 million of collaboration revenue under the Ono Agreement and $1.0 million under the Juno Agreement for the three months ended March 31, 2019[95][98] - The initial transaction price under the Ono Agreement is $30.0 million (upfront payment + estimated R&D fees), recognized over an estimated four-year period[95] Research and Development Expenses R&D expenses increased in Q1 2019, driven by higher compensation, consultant fees, equipment, and lease expenses, with further increases anticipated as product candidates advance Research and Development Expenses (in thousands) | Metric | Three Months Ended March 31, 2019 (in thousands) | Three Months Ended March 31, 2018 (in thousands) | | :------------------------- | :----------------------------------------------- | :----------------------------------------------- | | R&D Expenses | $17,728 | $11,476 | - The increase in R&D expenses primarily includes a $2.7 million increase in employee compensation, $1.5 million in third-party professional consultant expenses, $1.3 million in laboratory equipment/supplies, and $0.6 million in facility lease expense[106] General and Administrative Expenses G&A expenses increased in Q1 2019, primarily due to a rise in employee compensation and benefits expense, including stock-based compensation General and Administrative Expenses (in thousands) | Metric | Three Months Ended March 31, 2019 (in thousands) | Three Months Ended March 31, 2018 (in thousands) | | :------------------------- | :----------------------------------------------- | :----------------------------------------------- | | G&A Expenses | $5,350 | $3,604 | - The increase in G&A expenses primarily relates to a $1.4 million increase in employee compensation and benefits expense, including employee stock-based compensation expense[108] Other Income (Expense) Other income (expense), net, improved in Q1 2019, primarily due to increased interest income from cash and short-term investments, partially offset by interest expense Other Income (Expense), Net (in thousands) | Metric | Three Months Ended March 31, 2019 (in thousands) | Three Months Ended March 31, 2018 (in thousands) | | :---------------------------------- | :----------------------------------------------- | :----------------------------------------------- | | Other Income (Expense), Net | $686 | $(81) | Critical Accounting Policies and Significant Judgments and Estimates Financial statements rely on management's estimates, with the adoption of new lease guidance (ASC 842) being the only material change in Q1 2019 - Management's financial analysis relies on estimates and judgments, with the most significant relating to accrued expenses and stock-based compensation[103] - The adoption of new lease guidance (ASC 842) effective January 1, 2019, was the only material change to critical accounting policies during the three months ended March 31, 2019[103] Results of Operations This section compares financial performance for Q1 2019 and 2018, detailing changes in revenue, operating expenses, and other income/expense Comparison of the Three Months Ended March 31, 2019 and 2018 Collaboration revenue increased, while research and development and general and administrative expenses also rose, with other income (expense), net, showing a positive change Comparison of Financial Performance (in thousands) | Metric | Three Months Ended March 31, 2019 (in thousands) | Three Months Ended March 31, 2018 (in thousands) | Increase/(Decrease) (in thousands) | | :---------------------------------- | :----------------------------------------------- | :----------------------------------------------- | :--------------------------------- | | Collaboration revenue | $2,632 | $1,026 | $1,606 | | Research and development expense | $17,728 | $11,476 | $6,252 | | General and administrative expense | $5,350 | $3,604 | $1,746 | | Total other income (expense), net | $686 | $(81) | $767 | Liquidity and Capital Resources The company relies on financing and collaboration revenues due to losses and negative cash flows, with existing cash projected to fund operations for at least 12 months, but future capital needs are substantial and uncertain Operating Activities Cash used in operating activities increased in Q1 2019, primarily driven by the increase in net loss, partially offset by higher stock-based compensation expense Net Cash Used in Operating Activities (in thousands) | Metric | Three Months Ended March 31, 2019 (in thousands) | Three Months Ended March 31, 2018 (in thousands) | | :---------------------------------- | :----------------------------------------------- | :----------------------------------------------- | | Net Cash Used in Operating Activities | $(17,493) | $(12,551) | Investing Activities Investing activities provided cash in Q1 2019, a significant positive shift from prior year, mainly due to maturities of short-term investments offsetting purchases of property and equipment Net Cash Provided by (Used in) Investing Activities (in thousands) | Metric | Three Months Ended March 31, 2019 (in thousands) | Three Months Ended March 31, 2018 (in thousands) | | :---------------------------------- | :----------------------------------------------- | :----------------------------------------------- | | Net Cash Provided by (Used in) Investing Activities | $8,754 | $(43,844) | - Investing activities in Q1 2019 were primarily driven by $10.5 million in maturities of short-term investments, partially offset by $1.7 million in purchases of property and equipment[116] Financing Activities Financing activities provided cash in Q1 2019, mainly from common stock issuance, with the company historically funding operations via equity and debt sales Net Cash Provided by Financing Activities (in thousands) | Metric | Three Months Ended March 31, 2019 (in thousands) | Three Months Ended March 31, 2018 (in thousands) | | :---------------------------------- | :----------------------------------------------- | :----------------------------------------------- | | Net Cash Provided by Financing Activities | $1,258 | $355 | - As of March 31, 2019, the company had aggregate cash and cash equivalents of $183.0 million[117] - Public offerings in September 2018 and December 2017 generated net proceeds of $134.9 million and $43.0 million, respectively[118] - The $15.0 million 2017 Term Loan from Silicon Valley Bank had its interest-only period extended through July 31, 2019[122] Operating Capital Requirements The company anticipates continued losses and requires significant additional capital, with existing cash expected to fund operations for at least 12 months, but future needs are uncertain - The company anticipates continued losses and will require significant additional capital for research and development of product candidates and regulatory approvals[127] - Existing cash and cash equivalents ($183.0 million as of March 31, 2019) are believed to be sufficient to fund projected operating requirements for at least the next twelve months[127] - Future funding requirements are highly dependent on unpredictable factors such as the initiation, timing, progress, and costs of clinical trials, manufacturing, and regulatory approvals[127] Contractual Obligations and Commitments Material contractual obligations include a term loan with Silicon Valley Bank and a non-cancelable operating lease for office and laboratory space, with significant future minimum fixed payments - The company has a $15.0 million term loan with Silicon Valley Bank[130] - Future minimum fixed payments under the non-cancelable operating lease for office and laboratory space total $40.6 million through 2028[130] Off-Balance Sheet Arrangements The company did not have, and currently has no, material off-balance sheet arrangements - The company did not have, and does not currently have, any material off-balance sheet arrangements[131] Quantitative and Qualitative Disclosures About Market Risk The company faces interest rate risk primarily on cash and equivalents, but a change in market rates is not expected to materially impact financial results due to investment profile and debt terms Interest Rate Risk Primary market risk is interest income sensitivity from cash and money market funds, with floating-rate debt's floor and ceiling limiting material impact from interest rate changes - The company's primary exposure to market risk is interest income sensitivity, affected by changes in U.S. interest rates, particularly for cash and money market mutual funds[132] - A 10% change in market interest rates would not have a material impact on the company's financial condition or results of operations, due to the low-risk profile of its investments and the interest rate floor/ceiling on its floating-rate debt[132] Controls and Procedures Disclosure controls and procedures were effective as of March 31, 2019, with internal control enhancements made due to ASC 842 lease accounting adoption Disclosure Controls and Procedures Disclosure controls and procedures were evaluated by management and deemed effective at a reasonable assurance level as of March 31, 2019 - Disclosure controls and procedures were evaluated and deemed effective at the reasonable assurance level as of March 31, 2019[134] Changes in Internal Control over Financial Reporting No material changes in internal controls over financial reporting occurred, except for enhancements due to ASC 842 lease guidance adoption effective January 1, 2019 - No material changes in internal controls over financial reporting occurred during the latest fiscal quarter, other than enhancements due to the adoption and implementation of new lease guidance under ASC 842, effective January 1, 2019[135] PART II. OTHER INFORMATION Legal Proceedings The company is not involved in any material legal proceedings and does not anticipate existing claims to have a material adverse effect - The company is not a party to any material legal proceedings at this time and does not believe any existing claims would have a material adverse effect on its business[137] Risk Factors This section details risks spanning product development, regulatory approval, third-party reliance, intellectual property, commercialization, financial health, and stock ownership Risks Related to the Discovery, Development and Regulation of Our Product Candidates Substantial risks exist in product candidate discovery, development, and regulation, including clinical trial delays, funding needs, and complex, unpredictable regulatory approval for novel cellular therapies - The company may face delays or failures in initiating, conducting, or completing clinical trials for its product candidates (ProTmune, FATE-NK100, FT500, FT516) due to difficulties in patient enrollment, unexpected safety issues, or regulatory hurdles[139][141] - Development of product candidates will require substantial additional funding, and the company expects its research and development expenses to increase significantly[145] - The regulatory approval process for novel cellular therapies, especially iPSC-derived products, is difficult to predict, expensive, and may take longer due to a lack of prior experience and evolving regulatory requirements[158][160] - The manufacture of cell product candidates is complex and subject to risks such as process scale-out, reproducibility, and regulatory compliance, which could increase costs, limit supply, and delay commercialization[152][153] Risks Related to Our Reliance on Third Parties Reliance on third parties for manufacturing, research, and clinical trials introduces risks of non-performance, regulatory non-compliance, supply chain issues, and collaborator conflicts - The company relies on third parties for manufacturing product candidates for clinical trials and commercial sale, which entails risks related to regulatory compliance, quality assurance, and potential failure to meet specifications[169] - Dependence on third-party cell processing facilities for ProTmune and FATE-NK100 manufacturing requires consistent quality and adherence to regulatory requirements, with potential for delays if these facilities fail to comply[171] - Strategic partnerships, such as the Ono Agreement, involve risks that collaborators may shift priorities, fail to commit sufficient resources, or develop competing products, potentially delaying or harming product development[172][174] - Manufacturing depends on the availability and quality of reagents, specialized materials, equipment, and human donor material (for ProTmune and FATE-NK100), which may be difficult to source or have inconsistent attributes[175][177] Risks Related to Our Intellectual Property Commercial success depends on intellectual property protection, facing risks like uncertain patent scope, reliance on licensors, potential infringement, and challenges to inventorship or trade secrets - Inability to obtain and maintain adequate intellectual property protection for product candidates and cell programming technology could allow competitors to develop similar products, reducing demand and harming the business[182] - Reliance on licensors to prosecute and maintain patents and patent applications material to the business means any failure by licensors could adversely affect the company's intellectual property rights[184] - The company or its strategic partners may infringe the intellectual property rights of others, potentially leading to development delays, commercialization blocks, or substantial monetary damages[187][189] - Changes in U.S. patent law could diminish the value of patents in general, impairing the company's ability to protect its product candidates and technology[193][195] Risks Related to the Commercialization of Our Product Candidates Lack of marketing experience and uncertain commercial success due to market acceptance, pricing, and reimbursement risks, compounded by potential negative impacts from healthcare reforms - The company has no experience in marketing and selling therapeutic products, and commercial success depends on establishing internal capabilities or effectively partnering with third parties[197] - Commercial success depends on market acceptance by physicians, patients, and third-party payers, which is uncertain for novel therapies and could lead to insufficient product revenue[198][199] - Significant uncertainty exists regarding the pricing of novel cellular immunotherapy product candidates, and unfavorable pricing policies or reimbursement could impair commercial success[200][202] - Healthcare legislative or regulatory reform measures, such as the ACA and drug pricing scrutiny, may negatively impact the business by delaying approvals, restricting activities, or reducing reimbursement[204][208] Risks Related to Our Business and Industry Success depends on HSCT and cellular immunotherapy developments, facing intense competition, challenges in retaining personnel, and risks of misconduct or non-compliance with healthcare laws - The success of the company's product candidates is substantially dependent on developments within the field of HSCT and cellular immunotherapy; adverse developments could significantly harm business prospects[211] - The biotechnology and pharmaceutical industries are intensely competitive, and the company faces competition from entities with greater financial and other resources[212] - Inability to attract and retain qualified management, scientific, and clinical personnel and consultants could significantly impede the achievement of development objectives and business strategy[213] - The company is exposed to risks of employee fraud or other misconduct, including non-compliance with regulatory standards and healthcare fraud and abuse laws, which could result in significant fines or sanctions[223][225] Risks Related to Our Financial Condition and the Ownership of Our Common Stock Limited operating history, significant losses, fluctuating stock price, principal stockholder control, and potential dilution from future financings pose risks to financial condition and stock ownership - The company has a limited operating history, has incurred significant net losses since inception ($305.2 million accumulated deficit as of March 31, 2019), and anticipates continued significant losses for the foreseeable future[226] - The market price of the company's common stock is subject to wide fluctuations based on clinical trial results, regulatory developments, competitive announcements, and financing efforts[229][230] - Executive officers, directors, and affiliated entities beneficially own approximately 46.4% of outstanding voting stock, allowing them to influence management and matters submitted to stockholders for approval[232] - Future sales of additional equity or debt securities to fund operations may result in dilution to stockholders and could impose restrictions or limitations on the business[233] Unregistered Sales of Equity Securities and Use of Proceeds Information on unregistered equity sales and use of proceeds has been previously disclosed in the company's Form 8-K - All information regarding unregistered sales of equity securities and use of proceeds has been previously reported in the company's Current Report on Form 8-K[240] Defaults Upon Senior Securities The company reported no defaults upon senior securities during the period - There were no defaults upon senior securities[241] Mine Safety Disclosures This item is not applicable to the company's operations - Mine Safety Disclosures are not applicable to the company[242] Other Information No other information to report under this item - No other information to report[243] Exhibits This section lists all exhibits filed with Form 10-Q, including organizational documents, officer certifications, and XBRL taxonomy documents - Exhibits include the Amended and Restated Certificate of Incorporation, Bylaws, Specimen Common Stock Certificate, Certifications of Principal Executive and Financial Officers (pursuant to Rules 13a-14/15d-14 and 18 U.S.C. Section 1350), and XBRL Instance, Schema, Calculation, Definition, Label, and Presentation Documents[245] SIGNATURES The report is signed by J. Scott Wolchko, serving as President, CEO, Director, Principal Executive, Financial, and Accounting Officer - The report is signed by J. Scott Wolchko, President and Chief Executive Officer and Director, who also serves as Principal Executive Officer, Principal Financial Officer, and Principal Accounting Officer[250]