CDI(US:CODX)2020-03-30 21:30PART I Business Overview Co-Diagnostics, Inc. develops molecular diagnostic tools using proprietary Co-Primer PCR technology for rapid, accurate, and low-cost testing - Co-Diagnostics, Inc. develops, manufactures, and sells reagents and diagnostic equipment for molecular diagnostic tests, covering infectious diseases, liquid biopsy for cancer screening, and agricultural applications1781 - The company's proprietary Co-Primer PCR test design eliminates primer-dimer pairs, enabling rapid, low-cost, and accurate molecular testing, protected by seven granted or pending US and foreign patents182124828589 - In January 2020, the company completed the design for a COVID-19 PCR screening test and obtained CE-marking regulatory clearance by February 24, 2020, enabling sales in Europe and other markets2829319293 - CDI has obtained regulatory approval in Europe and India for PCR diagnostic tests covering COVID-19, tuberculosis, hepatitis B and C, human papilloma virus, Malaria, chikungunya, dengue, and Zika virus26303990 - The company formed an Indian joint venture, CoSara Diagnostics, Pvt., to manufacture and sell diagnostic tests in India, receiving a license for five tests in December 2019 and submitting for COVID-19 approval363794969798 - In June 2019, the company introduced diagnostics tests for mosquito DNA, including triplex tests for West Nile/Western Equine/St. Louis encephalitis and Zika/chikungunya/dengue, offering rapid results at competitive costs of $10-$15 per triplex test4546 Estimated Global Annual Demand for Diagnostic Tests | Disease | Estimated Annual Tests | | :-------------------------------- | :------------------- | | Tuberculosis | 10,400,000 | | Multi-drug resistant Tuberculosis | 580,000 | | Zika | 324,000,000 | | Hepatitis B | 240,000,000 | | Hepatitis C | 130,000,000 | | HIV | 36,700,000 | | Malaria | 214,000,000 | | Sexually Transmitted Illnesses | 357,000,000 | | Human papilloma virus | 291,000,000 | | Dengue | 390,000,000 | | Total Annual Tests | 1,993,680,000 | - Key competitive advantages include affordability, flexibility, speed (e.g., 30 days for COVID-19 assay design), accuracy, intellectual property exclusivity, and multiplexing capabilities4849505152535455 - The company is developing liquid biopsy tests for cancer screening, expected in 2020, and holds an exclusive worldwide licensing arrangement for CoPrimers in agriculture, generating royalties56575859 - Co-Diagnostics is an 'emerging growth company' and 'smaller reporting company,' benefiting from exemptions from certain SEC disclosure requirements and an extended transition period for new accounting standards626465 Risk Factors As a smaller reporting company, the registrant is exempt from providing specific risk factor disclosures in this annual report section - This section is not applicable to smaller reporting companies66 Unresolved Staff Comments The company has no unresolved staff comments from the Securities and Exchange Commission - There are no unresolved staff comments67 Properties The company's primary operational facilities in Salt Lake City, Utah, are under a month-to-month lease, with longer-term negotiations underway - Executive offices and lab facilities are located at 2401 S. Foothill Drive, Salt Lake City, Utah 8410969 - The company occupies approximately 10,273 square feet under a month-to-month lease at $14,831 per month, with negotiations for a longer-term lease underway69 - The company has no other properties69 Legal Proceedings The company is defending a libel lawsuit in Florida and has responded to FINRA and NASDAQ inquiries regarding stock price fluctuations - One lawsuit alleging libel is pending in Florida, which the company believes is groundless and will be vigorously defended70 - The company has received and responded to inquiries from FINRA and NASDAQ concerning a sudden rise in its stock price70 - To management's knowledge, no governmental authority is contemplating any proceeding likely to have a material adverse effect on the company70 Mine Safety Disclosures This item is not applicable to the company's operations - This item is not applicable71 PART II Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities The company's common stock trades on NASDAQ under 'CODX', experienced significant volatility, with 27 million shares outstanding as of March 2020, and no dividends paid or equity repurchases made - The company's common stock has been quoted on the NASDAQ market under the symbol 'CODX' since July 12, 201773 Common Stock High and Low Prices | Period | High ($) | Low ($) | | :-------------------------------- | :------- | :------ | | 2020 (through March 15) | 21.75 | 0.88 | | 2019 | | | | First Quarter | 3.77 | 0.90 | | Second Quarter | 1.20 | 0.69 | | Third Quarter | 2.00 | 0.79 | | Fourth Quarter | 1.20 | 0.85 | | 2018 | | | | First Quarter | 3.27 | 1.45 | | Second Quarter | 6.66 | 1.57 | | Third Quarter | 4.30 | 2.60 | | Fourth Quarter | 3.10 | 1.15 | - As of March 22, 2020, 27,438,701 shares of common stock were outstanding, held by approximately 336 record holders as of March 13, 2020675 - The company has never declared or paid cash dividends and plans to retain all available funds for future business development and expansion76 - The company relied on the exemption from registration under Section 4(2) of the Securities Act for recent issuances of unregistered securities78 - There were no purchases of equity securities by the issuer or affiliated purchasers79 Selected Financial Data As a smaller reporting company, Co-Diagnostics is not required to provide selected financial data in this annual report - Selected financial data is not required for the company80 Management's Discussion and Analysis of Financial Condition and Results of Operations This section analyzes Co-Diagnostics' 2019 and 2018 financial condition and operations, highlighting molecular diagnostics, recent product developments, market expansions, and liquidity maintained through significant early 2020 capital raises Overview This overview details Co-Diagnostics' molecular diagnostic business, proprietary Co-Primer PCR technology, recent COVID-19 test development, Indian joint venture, intellectual property, competitive landscape, and regulatory compliance - Co-Diagnostics, Inc. develops and sells molecular tools for infectious disease detection, cancer screening, and agricultural applications, utilizing proprietary Co-Primer PCR technology to automate and simplify testing81828384858688899091 - The company completed the design for a COVID-19 PCR screening test on January 23, 2020, and obtained CE-marking regulatory clearance by February 24, 2020, for sales in Europe and other markets9293 - The Indian joint venture, CoSara Diagnostics, obtained regulatory clearance for five IVD tests in December 2019, with additional tests (including COVID-19) submitted or planned for 20209496979899 - The company's intellectual property includes four granted U.S. patents (including CoPrimer technology) and three additional pending patents, along with copyrighted development software100101102 - The molecular diagnostics industry is highly competitive, with larger firms posing a challenge due to greater financial resources and established customer bases104106 - The company employs 23 full-time personnel in Utah and two outside, supplemented by independent contractors and sales representatives107 - Co-Diagnostics is regulated by the U.S. FDA, holds CE Marks for several tests (including COVID-19), and its Indian joint venture is regulated by the CDSCO108 - The company's executive offices and lab facilities in Salt Lake City, Utah, are leased month-to-month, covering approximately 10,273 square feet at $14,831 per month109 - A libel lawsuit is pending in Florida, which the company believes is groundless, and inquiries from FINRA and NASDAQ regarding stock price fluctuations have been addressed110 RESULTS OF OPERATIONS This section analyzes Co-Diagnostics' 2019 versus 2018 financial performance, detailing increased net sales and gross profit, decreased operating expenses, and a slight reduction in net loss Consolidated Statements of Operations (2019 vs. 2018) | Metric | 2019 ($) | 2018 ($) | Change ($) | Change (%) | | :-------------------------------- | :--------- | :--------- | :--------- | :--------- | | Net sales | 214,974 | 39,911 | 175,063 | 438.6% | | Cost of sales | 112,431 | 9,391 | 103,040 | 1097.2% | | Gross profit | 102,543 | 30,520 | 72,023 | 236.0% | | Total operating expenses | 5,996,284 | 6,148,336 | (152,052) | (2.5%) | | Total operating loss | (5,893,741) | (6,117,816) | 224,075 | (3.7%) | | Total other expense | (301,816) | (153,907) | (147,909) | 96.1% | | Loss before income taxes | (6,195,557) | (6,271,723) | 76,166 | (1.2%) | | Net loss | (6,195,557) | (6,271,723) | 76,166 | (1.2%) | | Net loss per share – basic and diluted | (0.36) | (0.50) | 0.14 | (28.0%) | | Weighted average shares – basic and diluted | 16,756,912 | 12,484,617 | 4,272,295 | 34.2% | Revenue Breakdown (2019 vs. 2018) | Revenue Source | 2019 ($) | 2018 ($) | | :----------------------- | :--------- | :--------- | | Testing equipment sales | 128,124 | 10,123 | | Agriculture license sales | 50,000 | 29,088 | | Diagnostic test sales | 36,850 | 700 | | Total Net Sales | 214,974 | 39,911 | - Cost of sales increased by $103,040 in 2019, primarily due to higher equipment sales, resulting in a gross profit of $102,543, up from $30,520 in 2018114 - Total operating expenses decreased by $152,052 in 2019, driven by a $73,513 decrease in general and administrative expenses and a $103,955 decrease in sales and marketing expenses, partially offset by a $10,279 increase in research and development expenses115116117118 - Interest and other expense increased by $147,909 in 2019, mainly due to an increased loss from the India joint venture ($194,117) and a $78,241 loss on debt extinguishment119 - The net loss decreased by $76,166 to $6,195,557 in 2019, compared to $6,271,723 in 2018120 LIQUIDITY AND CAPITAL RESOURCES This section details Co-Diagnostics' liquidity and capital resources, highlighting cash flow changes, significant capital raises in 2019 and early 2020, and sufficient cash for the next twelve months Key Financial Position (December 31, 2019 vs. 2018) | Metric | 2019 ($) | 2018 ($) | Change ($) | | :-------------------------- | :--------- | :--------- | :--------- | | Cash and cash equivalents | 893,138 | 950,237 | (57,099) | | Total current assets | 1,584,254 | 1,051,913 | 532,341 | | Total current liabilities | 328,070 | 2,351,983 | (2,023,913) | | Total stockholders' equity (deficit) | 1,737,256 | (1,058,811) | 2,796,067 | - Net cash used in operating activities increased to $5,525,091 in 2019 from $4,080,036 in 2018124155 - In 2019, the company received net proceeds of $5,000,000 from a registered direct offering and approximately $1,000,000 from preferred stock sales, and converted $2,000,000 of debt to preferred stock124131132155 - In early 2020, the company raised approximately $19.2 million in gross proceeds from three registered direct offerings of common stock (January 23: $5.0 million; February 10: $10.2 million; February 28: $4.0 million)126127128232233235 - Additional financing in early 2020 included $50,000 from warrant exercises, the cashless exercise of 759,445 warrants for 694,492 common shares, and the conversion of all 25,600 preferred shares to 2,133,333 common shares129236 - At current operating expenditures (approximately $460,000 per month in 2019), the company has sufficient cash to fund operations for the next twelve months and does not expect to raise additional capital without significant acquisitions or capital expansion125133 - Long-term capital needs for commercialization and future development of diagnostic tests are estimated at approximately $1,350,000 annually134 - As of December 31, 2019, the company had no off-balance sheet arrangements135 Quantitative and Qualitative Disclosures About Market Risk This section is not required for Co-Diagnostics as it qualifies as a smaller reporting company under SEC regulations - This disclosure is not required for the company136 Financial Statements and Supplementary Data This section presents Co-Diagnostics' audited consolidated financial statements for 2019 and 2018, including balance sheets, statements of operations, equity changes, cash flows, and notes, with an unqualified audit opinion Report of Independent Registered Public Accounting Firm Haynie & Company issued an unqualified audit opinion on Co-Diagnostics' 2019 and 2018 consolidated financial statements, affirming fair presentation in accordance with GAAP - Haynie & Company issued an unqualified opinion on the consolidated financial statements for December 31, 2019 and 2018, affirming fair presentation of financial position, results of operations, and cash flows in conformity with GAAP141 - Haynie & Company is registered with the PCAOB and has served as the company's auditor since 2016142145 - The audit did not include an audit of internal control over financial reporting, as the company is not required to have one143 Consolidated Balance Sheets This section presents Co-Diagnostics' consolidated balance sheets for 2019 and 2018, highlighting a significant improvement from stockholders' deficit to positive equity and a dramatic decrease in current liabilities Consolidated Balance Sheet Highlights (December 31, 2019 vs. 2018) | Metric | 2019 ($) | 2018 ($) | Change ($) | Change (%) | | :-------------------------------- | :--------- | :--------- | :--------- | :--------- | | Cash and cash equivalents | 893,138 | 950,237 | (57,099) | (6.0%) | | Total current assets | 1,584,254 | 1,051,913 | 532,341 | 50.6% | | Total current liabilities | 328,070 | 2,351,983 | (2,023,913) | (86.1%) | | Total liabilities | 478,070 | 2,611,983 | (2,133,913) | (81.7%) | | Total stockholders' equity (deficit) | 1,737,256 | (1,058,811) | 2,796,067 | 264.1% | - The company transitioned from a stockholders' deficit of $(1,058,811) in 2018 to positive equity of $1,737,256 in 2019, a significant improvement of $2,796,067149 - Total current liabilities decreased dramatically by $2,023,913 (86.1%) in 2019, primarily due to the conversion of $1,908,572 in current notes payable to preferred stock149 Consolidated Statements of Operations This section presents Co-Diagnostics' consolidated statements of operations for 2019 and 2018, detailing significant increases in net sales and gross profit, alongside a slight improvement in net loss Consolidated Statements of Operations (2019 vs. 2018) | Metric | 2019 ($) | 2018 ($) | Change ($) | Change (%) | | :-------------------------------- | :--------- | :--------- | :--------- | :--------- | | Net sales | 214,974 | 39,911 | 175,063 | 438.6% | | Cost of sales | 112,431 | 9,391 | 103,040 | 1097.2% | | Gross profit | 102,543 | 30,520 | 72,023 | 236.0% | | Total operating expenses | 5,996,284 | 6,148,336 | (152,052) | (2.5%) | | Total operating loss | (5,893,741) | (6,117,816) | 224,075 | (3.7%) | | Net loss | (6,195,557) | (6,271,723) | 76,166 | (1.2%) | | Net loss per share – basic and diluted | (0.36) | (0.50) | 0.14 | (28.0%) | - Net sales increased significantly by 438.6% to $214,974 in 2019, up from $39,911 in 2018152 - The net loss improved slightly by 1.2%, decreasing from $(6,271,723) in 2018 to $(6,195,557) in 2019152 Consolidated Statement of Changes in Stockholders' Equity (Deficit) This section details changes in Co-Diagnostics' stockholders' equity, showing a transition from deficit in 2018 to positive equity in 2019, driven by public offerings and preferred stock issuances - Total stockholders' equity shifted from a deficit of $(1,058,811) at December 31, 2018, to positive equity of $1,737,256 at December 31, 2019153 - Key contributions to equity in 2019 included $4,903,238 net proceeds from a public offering of common stock and $3,000,000 from preferred stock issuance (including $2,000,000 from debt conversion)153 - Stock-based compensation recognized in 2019 amounted to $1,088,386153 Consolidated Statements of Cash Flows This section presents Co-Diagnostics' consolidated statements of cash flows for 2019 and 2018, detailing increased cash usage in operating activities offset by significant financing cash from stock sales Consolidated Statements of Cash Flows (2019 vs. 2018) | Metric | 2019 ($) | 2018 ($) | | :------------------------------------------------------------------------------------------------ | :--------- | :--------- | | Net cash used in operating activities | (5,525,091) | (4,080,036) | | Net cash used by investing activities | (435,246) | (380,336) | | Net cash provided by financing activities | 5,903,238 | 1,876,155 | | Net increase (decrease) in cash | (57,099) | (2,584,217) | | Cash and cash equivalents end of period | 893,138 | 950,237 | - Net cash used in operating activities increased to $(5,525,091) in 2019, while net cash provided by financing activities significantly increased to $5,903,238, primarily from common and preferred stock sales155 - Non-cash investing and financing activities in 2019 included $379,487 for warrants issued for services, $440,000 for conversion of preferred stock to common, and $2,000,000 for conversion of debt to preferred stock155 Notes to Consolidated Financial Statements This section provides detailed notes to the consolidated financial statements, covering joint venture investments, debt conversions, stock-based compensation, royalty payments, preferred stock, NOLs, and significant early 2020 subsequent events - The company invested $322,000 in 2019 and $339,000 in 2018 for its 50% interest in the Indian joint venture, CoSara Diagnostics, accounted for using the equity method158 - The $2,000,000 Robert Salna Promissory Note from August 2018 was converted to Series A Convertible Preferred Stock on January 30, 2019, resulting in no outstanding notes payable at year-end 2019193194196 - Stock-based compensation expense was $589,683 in 2019 and $468,240 in 2018, with 2,021,817 options and 983,535 warrants outstanding at December 31, 2019200201208209 - A down round feature on 313,779 warrants led to an exercise price adjustment from $2.59 to $1.20 in 2019, resulting in a $78,090 impact206 - The company paid Dr. Satterfield $110,000 in 2019 and $100,000 in 2018 for accrued technology royalties, with $270,000 in unpaid accrued royalties remaining at December 31, 2019216217 - In January 2019, 30,000 shares of Series A Convertible Preferred Stock were issued for $3,000,000 (including $2,000,000 from debt conversion), convertible to common stock at $1.20 per share219 - Net operating loss carry-forwards of approximately $19,735,000 at December 31, 2019, are fully offset by a valuation allowance, with no tax benefit reported227 - Subsequent events in early 2020 include the completion and regulatory clearance of the COVID-19 test, three registered direct offerings raising approximately $19.2 million in gross proceeds, and significant warrant and preferred stock conversions231232233234235236 Changes in and Disagreements with Accountants on Accounting and Financial Disclosure The company reported no changes in or disagreements with its independent accountants regarding accounting principles or financial disclosure - There were no changes in or disagreements with accountants on accounting and financial disclosure240 Controls and Procedures As of December 31, 2019, disclosure controls and internal control over financial reporting were ineffective due to a material weakness in technical expertise, with remediation efforts underway - As of December 31, 2019, the company's disclosure controls and procedures were not effective due to a material weakness in internal control over financial reporting242244 - The identified material weakness is insufficient technical expertise on complex accounting and tax requirements, potentially leading to undetected material misstatements245 - Despite the material weakness, management concluded that the Consolidated Financial Statements fairly present the company's financial position, results of operations, and cash flows in conformity with U.S. GAAP247 - Remediation efforts include implementing internal control recommendations and planning to increase consultant involvement or expand accounting staff246 - An attestation report by the independent registered public accounting firm regarding internal control over financial reporting is not included, as the company is an emerging growth company248 Other Information The company reported no other information required for disclosure under this item - No other information is required to be disclosed249 PART III Directors, Executive Officers and Corporate Governance This section outlines Co-Diagnostics' executive officers, directors, and corporate governance, including independent board committees, a financial expert, conflict of interest policies, a code of ethics, and Section 16(a) compliance - Key executive officers include Dwight H. Egan (CEO, President, Chairman), Reed L. Benson (CFO, Secretary), and Brent Satterfield (Chief Science Officer)252253254261 - The Board of Directors includes independent members Eugene Durenard, James Nelson, Richard S. Serbin, and Edward L. Murphy, bringing diverse expertise252255257258259263 - The company maintains an Audit Committee (chaired by Mr. Durenard, an 'audit committee financial expert'), a Compensation Committee (chaired by Mr. Serbin), and a Corporate Governance and Nominating Committee (chaired by Mr. Nelson), all composed of independent directors263266267268269 - The company has a code of ethics for its principal executive, financial, and accounting officers, and a policy requiring disclosure of conflicts of interest272275 - All directors, executive officers, and greater than 10% shareholders complied with Section 16(a) filing requirements for the year ended December 31, 2019274 Executive Compensation Co-Diagnostics' executive compensation aligns pay with company and individual performance, utilizing base salaries, bonuses, and equity awards from the 2015 Long-term Incentive Plan, with director compensation including fees and stock options - The company's compensation philosophy links total cash compensation to company, department, and individual performance, with increased variability and at-risk compensation for higher responsibility levels280 - Executive compensation integrates competitive annual base salaries with performance-based bonuses and equity awards through the 2015 Long-term Incentive Plan, aligning executive interests with shareholders281286287 - The Compensation Committee evaluates company progress and executive services against development, financial, and sales and marketing milestones, benchmarking compensation against a peer group of diagnostic testing companies279284 Summary Compensation Table for Named Executive Officers | Name | Year | Salary ($) | Bonus ($) | Awards ($) | Total ($) | | :-------------------------------- | :--- | :--------- | :-------- | :--------- | :-------- | | Dwight H. Egan | 2019 | 275,000 | 20,000 | 165,000 | 460,000 | | President & CEO | 2018 | 275,000 | 12,500 | 186,000 | 463,500 | | | 2017 | 195,000 | 15,000 | 0 | 210,000 | | Reed L Benson | 2019 | 200,000 | 15,000 | 137,500 | 352,500 | | CFO & Secretary | 2018 | 200,000 | 10,000 | 155,000 | 365,000 | | | 2017 | 195,000 | 10,000 | 0 | 205,000 | | Brent Satterfield | 2019 | 237,500 | 0 | 0 | 237,500 | | Chief Technology Officer | 2018 | 237,500 | 0 | 0 | 237,500 | | | 2017 | 159,300 | 0 | 0 | 159,300 | - Dr. Satterfield also received $110,000 in 2019, $100,000 in 2018, and $170,000 in 2017 for accrued royalties under a technology license agreement290 - Non-employee directors receive annual fees of $35,000, additional fees for committee roles, and initial/annual grants of 25,000 immediately exercisable stock options297 Director Summary Compensation Table (2019) | Name | Fees Paid in Cash ($) | Options/Awards ($) | Total ($) | | :-------------------- | :-------------------- | :----------------- | :-------- | | Frank Kiesner (resigned) | 27,500 | 0 | 27,500 | | Richard Serbin | 55,000 | 17,750 | 72,750 | | Edward J. Borkowski (resigned) | 27,500 | 0 | 27,500 | | James Nelson | 18,333 | 27,500 | 45,833 | | Edward Murphy | 12,000 | 17,750 | 29,750 | | Eugene Durenard | 27,500 | 17,750 | 45,250 | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters As of March 19, 2020, Co-Diagnostics had 27,438,701 common shares outstanding, with directors and executive officers collectively owning 1.4%, and Reagents, LLC holding 6.3% as a 5% stockholder - As of March 19, 2020, there were 27,438,701 shares of common stock outstanding303 Beneficial Ownership (March 19, 2020) | Name | Title | Beneficially Owned Shares | Percent of Class | | :-------------------------------- | :-------------------------------- | :------------------------ | :--------------- | | Dwight H. Egan | CEO, President, Chairman | 150,000 | * (<1%) | | Reed L. Benson | CFO, Secretary | 125,000 | * (<1%) | | Edward Murphy | Director | 25,000 | * (<1%) | | Eugene Durenard | Director | 25,000 | * (<1%) | | James Nelson | Director | 25,000 | * (<1%) | | Richard S. Serbin | Director | 45,455 | * (<1%) | | Officers and Directors as a Group | (total of 6 persons) | 395,455 | 1.4% | | 5% Stockholders: | | | | | Reagents, LLC (Seth Egan) | | 1,746,796 | 6.3% | - Beneficial ownership includes shares over which a person exercises sole or shared voting/investment power, or has a right to acquire within 60 days303 - There are no known voting trusts or similar agreements, and no arrangements that may result in a change in control of the company304 Certain Relationships and Related Transactions, and Director Independence The company engages in related party transactions, primarily involving royalty payments to Dr. Satterfield and consulting fees to a former and current director in 2019 - The company paid Dr. Satterfield $110,000 in 2019 and $100,000 in 2018 for accrued royalties under the exclusive license agreement for CoPrimer technology309 - The license agreement with Dr. Satterfield was amended in March 2017 to cease ongoing royalties and pay down $700,000 of accrued royalties at a rate of $10,000 per month309 - In 2019, the company paid a one-time consulting fee of $35,000 to former director Frank Keisner and $30,000 to current director Richard Serbin for consulting services310 Principal Accountant Fees and Services Co-Diagnostics paid its independent auditors, Haynie & Company, $72,000 in 2019 and $69,000 in 2018 for audit and tax services, all pre-approved by the audit committee or Board of Directors Principal Accountant Fees (2019 vs. 2018) | Category | 2019 ($) | 2018 ($) | | :----------------- | :--------- | :--------- | | Audit fees | 69,000 | 66,000 | | Audit-related fees | 0 | 0 | | Tax fees | 3,000 | 3,000 | | All other fees | 0 | 0 | | Total | 72,000 | 69,000 | - Audit fees covered the annual audit and reviews of annual and quarterly reports311 - Tax fees included services for tax compliance and consultations312 - All audit and tax fees incurred in 2019 were pre-approved by the audit committee, and in 2018 by the Board of Directors, with a policy requiring advance approval for services exceeding $15,000311312313 PART IV Exhibits and Financial Statement Schedules This section lists all exhibits and financial statement schedules in the Annual Report on Form 10-K, covering corporate governance, various agreements, and certifications, with many incorporated by reference - The exhibits include corporate documents such as Articles of Incorporation and Bylaws, legal opinions, and various agreements including Underwriting, Subscription, Exclusive License, and Securities Purchase317318 - Also included are the 2015 Long-Term Incentive Plan, Code of Ethics, Subsidiaries of Registrant, Consents of auditors and legal counsel, and certifications by the CEO and Principal Financial Officer under the Sarbanes-Oxley Act317318 - Many exhibits are incorporated by reference from previous SEC filings, including Draft Registration Statements and Form S-1/A filings318