Annexon(ANNX) - 2021 Q3 - Quarterly Report

PART I—FINANCIAL INFORMATION Item 1. Financial Statements The company's unaudited financial statements show a significant increase in net loss and operating expenses Condensed Consolidated Balance Sheets Condensed Consolidated Balance Sheets (in thousands) | Metric | September 30, 2021 (Unaudited) | December 31, 2020 | |:---|:---|:---| | Total Assets | $310,156 | $355,946 | | Total Liabilities | $45,679 | $11,668 | | Total Stockholders' Equity | $264,477 | $344,278 | | Cash and Cash Equivalents | $68,519 | $268,565 | | Short-term Investments | $202,848 | $82,641 | - Total assets decreased by $45.79 million (12.86%) from December 31, 2020, to September 30, 2021, primarily driven by a significant reduction in cash and cash equivalents, partially offset by an increase in short-term investments and property and equipment[5] - Total liabilities increased substantially by $34.01 million (291.47%) due to the recognition of operating lease liabilities, non-current, which were $33.76 million as of September 30, 2021[5] Condensed Consolidated Statements of Operations Condensed Consolidated Statements of Operations (in thousands, except per share amounts) | Metric | Three Months Ended Sep 30, 2021 | Three Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | |:---|:---|:---|:---|:---| | Research and development | $27,581 | $11,775 | $72,849 | $31,279 | | General and administrative | $8,099 | $3,810 | $20,406 | $8,999 | | Total operating expenses | $35,680 | $15,585 | $93,255 | $40,278 | | Net loss | $(35,598) | $(15,638) | $(92,952) | $(40,219) | | Net loss per share (basic and diluted) | $(0.93) | $(0.77) | $(2.43) | $(4.79) | - Net loss for the three months ended September 30, 2021, increased by 127.6% to $35.6 million compared to $15.6 million in the same period of 2020, driven by higher operating expenses[8] - Net loss for the nine months ended September 30, 2021, increased by 131.1% to $93.0 million compared to $40.2 million in the same period of 2020[8] - Research and development expenses increased by 134.2% for the three months and 133.0% for the nine months ended September 30, 2021, reflecting increased clinical trial activities and manufacturing costs[8] Condensed Consolidated Statements of Comprehensive Loss Condensed Consolidated Statements of Comprehensive Loss (in thousands) | Metric | Three Months Ended Sep 30, 2021 | Three Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | |:---|:---|:---|:---|:---| | Net loss | $(35,598) | $(15,638) | $(92,952) | $(40,219) | | Other comprehensive gain (loss): | | | | | | Foreign currency translation adjustment | $(3) | $4 | $(5) | $2 | | Unrealized gain (loss) on available for sale securities | $(7) | — | $7 | — | | Comprehensive loss | $(35,608) | $(15,634) | $(92,950) | $(40,217) | - Comprehensive loss for the three months ended September 30, 2021, was $35.61 million, an increase from $15.63 million in the prior year, primarily due to the higher net loss[11] Condensed Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit) Stockholders' Equity Changes (in thousands, except share amounts) | Metric | December 31, 2020 | September 30, 2021 | |:---|:---|:---| | Common Stock Shares | 38,157,618 | 38,370,098 | | Common Stock Cost | $38 | $38 | | Additional Paid-In Capital | $510,309 | $523,458 | | Accumulated Other Comprehensive Loss | $(77) | $(75) | | Accumulated Deficit | $(165,992) | $(258,944) | | Total Stockholders' Equity | $344,278 | $264,477 | - Total stockholders' equity decreased by $79.8 million from December 31, 2020, to September 30, 2021, primarily due to an increase in accumulated deficit, partially offset by an increase in additional paid-in capital from stock-based compensation and option exercises[14] Condensed Consolidated Statements of Cash Flows Condensed Consolidated Statements of Cash Flows (in thousands) | Activity | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | |:---|:---|:---| | Net cash used in operating activities | $(77,789) | $(33,831) | | Net cash used in investing activities | $(121,933) | $(292) | | Net cash provided by financing activities | $847 | $360,876 | | (Decrease) increase in cash, cash equivalents, and restricted cash | $(198,875) | $326,753 | | Cash, cash equivalents and restricted cash, End of period | $69,685 | $370,686 | - Net cash used in operating activities increased by 129.9% to $77.8 million for the nine months ended September 30, 2021, compared to $33.8 million in the prior year, driven by higher net loss[21] - Net cash used in investing activities significantly increased to $121.9 million for the nine months ended September 30, 2021, primarily due to purchases of available-for-sale securities[21] - Net cash provided by financing activities decreased substantially to $0.8 million for the nine months ended September 30, 2021, from $360.9 million in the prior year, which included significant proceeds from the IPO and preferred stock issuance[21] Notes to Condensed Consolidated Financial Statements 1. Organization - Annexon, Inc. is a clinical-stage biopharmaceutical company focused on developing complement medicines for classical complement-mediated disorders of the body, brain, and eye[23] - The company completed its Initial Public Offering (IPO) on July 28, 2020, issuing 14,750,000 shares of common stock at $17.00 per share, generating net proceeds of approximately $262.4 million[24] - As of September 30, 2021, the company had an accumulated deficit of $258.9 million and cash, cash equivalents, and short-term investments of $271.4 million, projecting sufficient liquidity for at least the next 12 months[26] 2. Basis of Presentation and Significant Accounting Policies - The unaudited condensed consolidated financial statements are prepared in accordance with GAAP and SEC rules for interim reporting, reflecting normal recurring adjustments[27][29] - The company adopted ASU No. 2016-02, Leases (Topic 842), on January 1, 2021, using the modified retrospective approach, resulting in the recognition of ROU assets of $461,000 and corresponding lease liabilities of $605,000[49] - Research and development expenses are expensed as incurred, with advance payments deferred as prepaid expenses and expensed as services are performed[40] - Stock-based compensation is recognized using a fair value method (Black-Scholes model) over the vesting period, with performance-based awards recognized when probable of being met[42][43] 3. Fair Value Measurements - The company measures financial assets and liabilities at fair value using a three-level hierarchy based on observable inputs[53] Fair Value of Financial Assets (in thousands) | Asset Category | Valuation Hierarchy | September 30, 2021 Aggregate Fair Value | |:---|:---|:---| | Money market funds | Level 1 | $67,937 | | Commercial paper | Level 2 | $115,867 | | Corporate debt | Level 2 | $53,104 | | Government bonds | Level 2 | $33,877 | | Total assets | | $270,785 | 4. Balance Sheet Components Prepaid Expenses and Other Current Assets (in thousands) | Category | September 30, 2021 | December 31, 2020 | |:---|:---|:---| | Prepaid research and development costs | $1,805 | $1,039 | | Prepaid insurance | $1,845 | $1,236 | | Total prepaid expenses and other current assets | $4,131 | $2,805 | Property and Equipment, Net (in thousands) | Category | September 30, 2021 | December 31, 2020 | |:---|:---|:---| | Total property and equipment, gross | $15,826 | $3,906 | | Less: accumulated depreciation | $(3,607) | $(1,971) | | Total property and equipment, net | $12,219 | $1,935 | - Construction-in-progress significantly increased to $11.39 million as of September 30, 2021, from zero at December 31, 2020, indicating substantial capital expenditures[61] Accrued Liabilities (in thousands) | Category | September 30, 2021 | December 31, 2020 | |:---|:---|:---| | Accrued research and development expenses | $3,165 | $3,260 | | Accrued compensation | $2,781 | $2,543 | | Total accrued liabilities | $7,059 | $6,497 | 5. Commitments and Contingencies - The company entered into a new Brisbane Lease in December 2020, which commenced in May 2021, leading to the recognition of operating lease ROU assets of $21.0 million and lease liabilities of $22.2 million[64][65] - Operating lease cost for the three and nine months ended September 30, 2021, was $1.1 million and $2.0 million, respectively, a significant increase from $0.1 million and $0.3 million in the prior year periods[66] Future Minimum Lease Payments (in thousands) | Period | Total Undiscounted Lease Payments | |:---|:---| | 2021 (remaining three months) | $63 | | 2022 | $4,203 | | 2023 | $4,742 | | 2024 | $4,907 | | 2025 | $5,079 | | Thereafter | $32,833 | | Total undiscounted lease payments | $51,827 | - The company has an exclusive licensing agreement with Stanford, requiring annual license maintenance fees, potential future milestone payments up to $500,000, and low single-digit royalty payments on net sales[69] - Received $135,000 in funding during the nine months ended September 30, 2021, under a Sponsored Research Agreement for multiple sclerosis research, recorded as other income[70] 6. Stockholders' Equity Common Stock Reserved for Issuance | Category | September 30, 2021 | December 31, 2020 | |:---|:---|:---| | Options issued and outstanding | 5,918,981 | 3,909,873 | | Options available for future grant | 2,019,422 | 2,707,947 | | Common stock reserved for 2021 ATM program | 5,265,929 | — | | Reserved for employee stock purchase plan | 734,903 | 360,086 | | Total common stock reserved | 13,939,235 | 6,977,906 | - In August 2021, the company entered into a sales agreement for an at-the-market (ATM) offering program to sell up to $100.0 million of common stock, with no shares sold as of September 30, 2021[75] 7. Equity Incentive Plan - The 2020 Incentive Award Plan and Employee Stock Purchase Plan (ESPP) became effective with the IPO in July 2020[76] Stock Option Activity (as of September 30, 2021) | Metric | Number of Shares | Weighted-Average Exercise Price Per Share | |:---|:---|:---| | Balances as of December 31, 2020 | 3,909,873 | $10.78 | | Stock options granted | 2,688,600 | $26.32 | | Stock options exercised | (205,721) | $5.46 | | Stock options forfeited | (473,771) | $24.00 | | Balances as of September 30, 2021 | 5,918,981 | $16.97 | | Exercisable as of September 30, 2021 | 1,963,823 | $9.57 | - Total stock-based compensation expense recognized was $4.4 million for the three months and $11.9 million for the nine months ended September 30, 2021, significantly higher than the prior year[83] - As of September 30, 2021, unrecognized stock-based compensation cost was $58.0 million, to be recognized over an estimated weighted-average period of 3.23 years[84] 8. Income Taxes - The company incurred insignificant income tax provisions for the periods presented, with U.S. federal and California deferred tax assets from net operating losses fully reserved[91] 9. Net Loss Per Share Attributable to Common Stockholders Potentially Dilutive Shares Excluded from Diluted EPS Calculation | Category | Three Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2021 | |:---|:---|:---| | Stock options to purchase common stock | 5,918,981 | 5,918,981 | | Shares subject to employee stock purchase plan | 9,538 | 9,538 | | Total | 5,928,519 | 5,928,519 | - Potentially dilutive shares, including stock options and ESPP shares, were excluded from diluted net loss per share calculations due to their anti-dilutive effect, as the company was in a net loss position[93][44] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses increased net losses from expanded R&D, COVID-19 impacts, and the company's liquidity position Overview - Annexon is a clinical-stage biopharmaceutical company developing new complement medicines for classical complement-mediated disorders, targeting C1q to block the classical complement pathway[98] - The company's pipeline includes ANX005 (IV), ANX007 (intravitreal), ANX009 (subcutaneous), and preclinical candidates ANX105 and ANX1502, with ongoing clinical trials in GBS, warm autoimmune hemolytic anemia, Huntington's Disease, ALS, and geographic atrophy[99][100] - Net losses were $35.6 million and $93.0 million for the three and nine months ended September 30, 2021, respectively, with an accumulated deficit of $258.9 million as of September 30, 2021[103] Initial Public Offering - The company completed its IPO on July 28, 2020, selling 14,750,000 shares and an additional 2,139,403 shares to underwriters, generating net proceeds of approximately $262.4 million[104] Impact of COVID-19 Pandemic - The COVID-19 pandemic has caused interruptions in clinical trial activities, shortages in clinical site staff, longer timelines for site initiation, and temporary shortages in lab supplies[105] - The extent of the pandemic's impact on clinical trials, business, financial condition, and development timelines remains uncertain and depends on various factors including outbreak duration, variants, and governmental restrictions[105] Components of Operating Results - The company has not generated revenue from product sales and does not expect to in the foreseeable future[106] - Research and development expenses, a significant portion of operating expenses, include direct costs (preclinical/clinical services, manufacturing, supplies) and indirect costs (personnel, facilities, depreciation)[107] - General and administrative expenses primarily consist of compensation, professional fees, and allocated facilities costs, expected to increase with business growth and public company operations[110][111] Results of Operations Comparison of the Three Months Ended September 30, 2021 and 2020 Operating Results (Three Months Ended September 30, in thousands) | Metric | 2021 | 2020 | Dollar Change | % Change | |:---|:---|:---|:---|:---| | Research and development | $27,581 | $11,775 | $15,806 | 134% | | General and administrative | $8,099 | $3,810 | $4,289 | 113% | | Total operating expenses | $35,680 | $15,585 | $20,095 | 129% | | Net loss | $(35,598) | $(15,638) | $(19,961) | 128% | - Research and development expenses increased by $15.8 million (134%) due to increased clinical outside services, contract manufacturing, compensation, and facilities costs related to ongoing and planned clinical trials[116] - General and administrative expenses increased by $4.3 million (113%) due to higher compensation, professional services (accounting, legal, insurance), and facilities costs[119] Comparison of the Nine Months Ended September 30, 2021 and 2020 Operating Results (Nine Months Ended September 30, in thousands) | Metric | 2021 | 2020 | Dollar Change | % Change | |:---|:---|:---|:---|:---| | Research and development | $72,849 | $31,279 | $41,570 | 133% | | General and administrative | $20,406 | $8,999 | $11,407 | 127% | | Total operating expenses | $93,255 | $40,278 | $52,977 | 132% | | Net loss | $(92,952) | $(40,219) | $(52,738) | 131% | - Research and development expenses increased by $41.6 million (133%) due to expanded clinical and nonclinical outside services, contract manufacturing for product candidates, increased compensation, and facilities costs[124] - General and administrative expenses increased by $11.4 million (127%) due to higher compensation (including stock-based compensation), professional services, and facilities costs[125] Liquidity and Capital Resources - The company has funded operations primarily through equity sales, raising $233.9 million from preferred stock and $262.4 million from its IPO[126] - As of September 30, 2021, cash, cash equivalents, and short-term investments totaled $271.4 million, with an accumulated deficit of $258.9 million[126] Historical Cash Flows (Nine Months Ended September 30, in thousands) | Activity | 2021 | 2020 | |:---|:---|:---| | Net cash used in operating activities | $(77,789) | $(33,831) | | Net cash used in investing activities | $(121,933) | $(292) | | Net cash provided by financing activities | $847 | $360,876 | - Cash used in operating activities increased to $77.8 million in 2021 from $33.8 million in 2020, primarily due to increased net loss[129] - Cash used in investing activities significantly increased to $121.9 million in 2021, mainly due to purchases of available-for-sale securities[130] - Cash provided by financing activities decreased to $0.8 million in 2021 from $360.9 million in 2020, as the prior year included IPO proceeds[131] - The company expects existing capital to fund operations into 2024 but anticipates needing additional funding through equity offerings, debt financings, or collaborations to support increasing R&D and potential commercialization efforts[132][134] Off-Balance Sheet Arrangements - The company has not engaged in any off-balance sheet arrangements since its inception[135] Emerging Growth Company and Smaller Reporting Company Status - The company is an 'emerging growth company' and 'smaller reporting company,' allowing it to delay adopting new accounting standards and utilize reduced disclosure requirements[136][137] - As of June 30, 2021, the company's public float exceeded $700 million, meaning it will qualify as a 'large accelerated filer' by the end of the current fiscal year and will no longer be an emerging growth company[138] Critical Accounting Policies and Estimates - No material changes to critical accounting policies were identified, except for the adoption of ASU No. 2016-02, Leases (Topic 842), on January 1, 2021[141] - The adoption of Topic 842 requires recognition of operating lease right-of-use (ROU) assets and lease liabilities on the balance sheet for leases with terms greater than 12 months[142] Recent Accounting Pronouncements Not Yet Adopted - The company is assessing the impact of ASU No. 2016-13, Financial Instruments-Credit Losses (Topic 326), which will be effective when it no longer qualifies as an emerging growth or smaller reporting company[52][144] Item 3. Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, Annexon, Inc. is not required to provide these disclosures - The company is not required to provide quantitative and qualitative disclosures about market risk as it qualifies as a smaller reporting company[146] Item 4. Controls and Procedures Management concluded disclosure controls were effective, noting changes from a new ERP system implementation Evaluation of Disclosure Controls and Procedures - Management, with CEO and CFO participation, concluded that disclosure controls and procedures were effective as of September 30, 2021, providing reasonable assurance for timely and accurate reporting[147] Changes in Internal Control over Financial Reporting - During the quarter ended March 31, 2021, the company launched the NetSuite ERP system, leading to modifications in internal control processes and procedures[148] - No other changes in internal control over financial reporting materially affected, or are reasonably likely to materially affect, the company's internal control during the quarter ended September 30, 2021[149] PART II—OTHER INFORMATION Item 1. Legal Proceedings The company is not currently a party to any material legal proceedings - The company is not a party to any material legal proceedings at this time[151] Item 1A. Risk Factors The company faces significant risks related to its limited operating history, financing needs, and product development Risk Factor Summary - The company is a clinical-stage biopharmaceutical company with a limited operating history and no approved products, incurring significant losses and anticipating continued losses[153] - Substantial additional financing is required, and failure to obtain it could delay or terminate product development and commercialization efforts[153] - Business heavily depends on successful development, regulatory approval, and commercialization of early-stage product candidates[153] - Public health crises, such as the COVID-19 pandemic, could materially and adversely affect preclinical and clinical trials, business, financial condition, and results of operations[153] Risks Related to Our Limited Operating History, Financial Condition and Capital Requirements - The company has incurred significant operating losses since inception, with a net loss of $93.0 million for the nine months ended September 30, 2021, and an accumulated deficit of $258.9 million[156] - Substantial additional financing is required to fund ongoing R&D, clinical trials, and potential commercialization, with existing capital expected to fund operations into 2024[157][158] - Decisions on prioritizing product candidates and therapeutic areas may divert resources from more profitable opportunities or those with a higher likelihood of success[164][166] - Quarterly and annual operating results may fluctuate significantly due to factors like R&D investment, clinical trial timing, manufacturing costs, and regulatory approvals, making future results difficult to predict[168] Risks Related to Our Business - The business is heavily dependent on the successful development, regulatory approval, and commercialization of product candidates, which are in early clinical stages and may take many years to achieve[170][171] - Clinical trials may face substantial delays or termination due to factors such as the COVID-19 pandemic, regulatory disagreements, patient enrollment difficulties, or unforeseen safety issues[188][192] - Adverse events or undesirable side effects from product candidates could halt clinical development, delay regulatory approval, limit commercial potential, or result in significant negative consequences, including product liability claims[200][202] - Interim 'top-line' and preliminary data from studies are subject to change as more data become available and may differ from final results, potentially harming business prospects[204][205] - The company relies on third-party suppliers for manufacturing product candidates and commercial supplies, and their failure to comply with regulations or provide sufficient quantities could materially affect the business[234][237] - Significant competition exists in the biopharmaceutical industry from companies with greater resources, potentially hindering market penetration and success[245] - Failure to obtain or maintain adequate coverage and reimbursement for product candidates, if approved, could limit marketability and revenue generation[246][248] - The company previously identified and remediated a material weakness in internal control over financial reporting, but future weaknesses could lead to financial misstatements or reporting failures[254][255] Risks Related to Intellectual Property - Product candidates could infringe third-party patent rights, leading to costly litigation, substantial damages, or limitations on commercialization[274] - Inability to obtain, maintain, and enforce intellectual property protection could allow competitors to market similar products, harming the company's competitive position[278] - Failure to prevent disclosure of trade secrets or confidential information to third parties could impair the company's competitive position[292] - Licenses for third-party intellectual property may be subject to early termination if the company fails to comply with obligations, resulting in loss of material rights[293][294] - Joint ownership of patent rights with third parties may limit the company's ability to out-license or prevent others from out-licensing these rights in certain countries[300] - Challenges to inventorship or ownership of patents and other intellectual property could result in loss of valuable rights and litigation costs[301][303] - Inadequate protection of trademarks and trade names could hinder name recognition and adversely affect the business[305] - Protecting intellectual property rights globally is expensive and challenging, as foreign laws may not offer the same extent of protection as in the United States[306] Risks Related to Government Regulation - Approved products will remain subject to ongoing regulatory scrutiny, including manufacturing, labeling, promotion, and post-marketing study requirements, with non-compliance leading to significant penalties[308][311] - Disruptions at the FDA and other government agencies, such as funding shortages or global health concerns, could delay product development, approval, or commercialization[226][227] - Data from clinical trials conducted outside the United States may not be accepted by the FDA or comparable foreign regulatory authorities, requiring additional costly and time-consuming trials[229] - Failure to obtain regulatory approval in multiple jurisdictions would limit market opportunities and adversely affect the business[231] - If a small molecule product candidate obtains regulatory approval, it may face competition from generic versions sooner than anticipated, leading to a material decline in sales[323][326] - Business operations and relationships are subject to healthcare regulatory laws (e.g., Anti-Kickback Statute, False Claims Act, HIPAA), with non-compliance potentially leading to significant penalties[327][328] Risks Related to Our Common Stock - The company's stock price may be highly volatile due to clinical trial results, regulatory announcements, competition, and general market conditions, potentially leading to a decline in stock price[329][331] - An active, liquid, and orderly market for common stock may not develop or be sustained, impairing the ability to sell shares or raise capital[333] - As an 'emerging growth company' and 'smaller reporting company,' reduced disclosure requirements may make the common stock less attractive to investors, potentially increasing stock price volatility[334][338] - Operating as a public company incurs significant costs and requires substantial management time for compliance, with potential sanctions for failure to comply with rules like Section 404 of Sarbanes-Oxley Act[338][341] - Future sales of common stock, including through at-the-market offerings, could result in immediate dilution for stockholders and a decline in stock price[343] - Principal stockholders and management own a significant percentage of stock, allowing them to exert substantial control over matters subject to stockholder approval[345] - The ability to use net operating loss carryforwards and other tax attributes may be limited due to 'ownership changes' under Sections 382 and 383 of the Internal Revenue Code[347] - Provisions in charter documents and Delaware law could discourage takeovers and entrench management[348][350] - The company does not intend to pay dividends on common stock, meaning returns will depend on stock price appreciation[357] General Risk Factors - Changes in tax laws and regulations, or their interpretation, may have a material adverse effect on the business, financial condition, and results of operations[361] - Compliance with U.S. and foreign export/import controls, sanctions, anti-corruption, and anti-money laundering laws is critical, with violations leading to criminal liability and other serious consequences[362] - Significant disruptions of information technology systems, data security breaches, or other incidents could materially adversely affect the business, results of operations, and financial condition[363][366] - Failure to comply with health and data protection laws and regulations (e.g., HIPAA, GDPR, CCPA) could lead to government enforcement actions, penalties, private litigation, or adverse publicity[367][372] - If securities or industry analysts do not publish research or issue adverse opinions, the stock price and trading volume could decline[374] - The company may be subject to securities litigation, which is expensive and could divert management's attention[375] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds Net proceeds from the July 2020 IPO were invested in cash equivalents and marketable securities - No unregistered sales of equity securities were reported[377] - Net proceeds from the July 2020 IPO, approximately $262.4 million, were invested in cash equivalents and marketable securities as planned[377] Item 3. Defaults Upon Senior Securities The company reported no defaults upon senior securities - No defaults upon senior securities were reported[377] Item 4. Mine Safety Disclosures Mine safety disclosures are not applicable to the company - Mine safety disclosures are not applicable to the company[377] Item 5. Other Information The company reported no other information for this period - No other information was reported[377] Item 6. Exhibits This section lists exhibits filed, including corporate governance documents, agreements, and required certifications - Exhibits include Amended and Restated Certificate of Incorporation and Bylaws, Sales Agreement with Cowen and Company, LLC, and Employment Agreement with Larry Mattheakis, Ph.D[379] - Certifications from the Principal Executive Officer and Principal Financial Officer (pursuant to Rules 13a-14(a) and 15d-14(a)) and a certification pursuant to 18 U.S.C. Section 1350 are included[379] - Inline XBRL documents (Instance, Schema, Calculation, Definition, Label, Presentation Linkbase Documents) and the Cover Page Interactive Data File are also filed[379] SIGNATURES The report was duly signed by the CEO and CFO on November 9, 2021 - The report was signed by Douglas Love, Esq., President and Chief Executive Officer, and Jennifer Lew, Executive Vice President and Chief Financial Officer, on November 9, 2021[380][381]