MAIA Biotechnology, Inc. 10-K

Item 5 . Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market Information and Holders Our common stock is traded on NYSE American under the symbol “MAIA”. As of March 22, 2023, 10,996,404 shares of the Company’s common stock were issued and outstanding and were owned by approximately 136 holders of record. The actual number of stockholders is greater than this number of record holders and includes stockholders who are beneficial owners but whose shares are held in street name by brokers and other nominees. Dividend Policy We have never declared or paid any cash dividends on our common stock or any other securities. We anticipate that we will retain all available funds and any future earnings, if any, for use in the operation of our business and do not anticipate paying cash dividends in the foreseeable future. In addition, future debt instruments may materially restrict our ability to pay dividends on our common stock. Payment of future cash dividends, if any, will be at the discretion of the board of directors after taking into account various factors, including our financial condition, operating results, current and anticipated cash needs, the requirements of current or then-existing debt instruments and other factors the board of directors deems relevant Recent Sales of Unregistered Securities During January and February 2022, we issued and sold 263,729 shares of our common stock with an aggregate principal amount of approximately $2.4 million. Between April 22, 2022 and May 3, 2022, warrant holders exercised warrants, resulting in the issuance of 153,000 shares of common stock for proceeds of approximately $275,400. In May 2022, we issued and sold 11,111 shares of our common stock with an aggregate principal amount of approximately $0.1 million. On December 18, 2022, we entered into an agreement with FORCE Family Office, LLC (“Force”) for the provision of investor relations services from January 16, 2023 through July 16, 2023, pursuant to which we issued 18,000 shares of common stock on January 16, 2023. Pursuant to the agreement, we also agreed to issue an additional 18,000 shares of common stock on April 16, 2023 unless the agreement is terminated beforehand. On March 8, 2023, we entered into an agreement with The Money Channel NYC Inc. for media services, pursuant to which we agreed to issue 22,500 shares of common stock on March 8, 2023 and an additional 22,500 shares of common stock every ninety days after the execution date of the contract until termination of the agreement. The term of the agreement extends for 180 days, and renews automatically until we provide written notice prior to the end of the term. Between January 1, 2021 and August 1, 2022, we granted to our employees, officers, directors and other persons who provide services to us options to purchase up to 2,634,513 shares of common stock under the 2018 Stock Option Plan and the Amended and Restated 2020 Stock Option Plan, at a weighted average exercise price of $3.21 per share. In addition, we issued to certain persons who provided services to us and in conjunction with convertible notes, warrants to purchase up to 769,865 shares of our common stock at a weighted average exercise price of $6.04 per share, which expire at various dates through September 2028 and vested upon issuance. No underwriters were involved in the foregoing issuances of securities. The securities described above were issued to investors in reliance upon the exemption from the registration requirements of the Securities Act, as set forth in Section 4(a)(2) under the Securities Act relative to transactions by an issuer not involving any public offering, to the extent an exemption from such registration was required. The recipient of securities in the transactions described above represented that it was an accredited investor and was acquiring the securities for their own account for investment purposes only, and not with a view to, or for sale in connection with, any distribution thereof and that they could bear the risks of the investment and could hold the securities for an indefinite period of time and appropriate legends were affixed to the instruments representing such securities issued in such transactions. Item 6 . [Reserved] 80 Item 7 . Management’s Discussion and Analysis of Financial Condition and Results of Operations. You should read the following discussion together with our financial statements and the related notes included elsewhere in this Annual Report on Form 10-K. This discussion contains forward-looking statements that are based on our current expectations, estimates and projections about our business and operations. Our actual results may differ materially from those currently anticipated and expressed in such forward-looking statements as a result of a number of factors, including those which we discuss under “Risk Factors” and elsewhere in this Annual Report on Form 10-K. See “Cautionary Note Regarding Forward-Looking Statements.” Overview We are a clinical stage biotechnology company engaged in the discovery, development and commercialization of therapies targeting cancer. Our initial disease target is lung cancer, a serious medical condition with an incidence of over 235,000 new cases in the US in 2021, representing 12.4% of all cancers, and over 131,000 deaths, or 21.7% of all cancers. Worldwide, lung cancer incidence is over 2,200,000 per year (ranking second only after breast cancer), and mortality over 1,800,000 (ranking first). Specifically, we are targeting Non-Small Cell Lung Cancer (NSCLC), which represents 85% of all lung cancers. We accomplished the following key milestones: • In November 2018, we in-licensed THIO from University of Texas Southwestern, in Dallas. The patent license is global and exclusive for the duration of the patients’ lives. • In 2019, we completed a common stock seed round in the amount of $2 million. • In 2019, we generated the first data for THIO demonstrating complete regression with no recurrence when administered in advance of atezolizumab (TecentriQ®; Genentech), in colorectal and lung cancer preclinical models. • In the First Quarter 2020, we filed a provisional patent application for THIO in sequential combination with checkpoint inhibitors, covering all tumor types. The patent was allowed in the US in the First Quarter 2021 and expires in 2041. • In the First Quarter 2021, we entered into a Drug Supply Agreement with Regeneron Pharmaceuticals, Inc. Under this agreement, Regeneron will provide cemiplimab (LIBTAYO; anti-PD-1 checkpoint inhibitor) at no charge for the THIO-101 trials, testing THIO administration for immune activation followed by cemiplimab in NSCLC. This drug supply agreement replaces direct drug purchase expense that we would be otherwise required to incur. In exchange, Regeneron received development exclusivity in NSCLC for the duration of the trial which is expected to be two years, meaning we cannot conduct trials in NSCLC with another checkpoint inhibitor during the time of the trial. All other areas of study and development in any other tumor types remain open. • In the First Quarter 2021, we initiated our clinical supply manufacturing (CMC) under Good Manufacturing Practices (GMP) conditions to provide clinical supply for THIO-101 and other development needs. • In the Second Quarter 2021, we completed a convertible note funding round in the amount of approximately $8 million. • In the Third Quarter 2021 and Fourth Quarter 2021, we sold common shares of MAIA for total proceeds of approximately $6.2 million. • In the First Quarter 2022, we completed the Crossover Round for total proceeds of approximately $2.4 million. • In the First Quarter 2022, THIO received approval by the Bellberry Human Research Ethics Committee (HREC) in Australia to initiate the THIO-101 Phase 2 clinical study. • In March 2022, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to THIO for the treatment of hepatocellular carcinoma, and in May 2022, the FDA granted ODD to THIO for the treatment of small-cell lung cancer. The FDA’s Office of Orphan Products Development may grant orphan designation status to drugs and biologics that are intended for the treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the U.S. Orphan Drug Designation provides certain benefits, including financial incentives, to support clinical development and the potential for up to seven years of market exclusivity for the drug for the designated orphan indication in the U.S. if the drug is ultimately approved for its designated indication. 81 • In May 2022, we completed the Additional Round for total proceeds of approximately $99,999. • In May 2022, we entered into a research and collaboration agreement with the Nationwide Children’s Hospital to evaluate the potential of THIO in combination with current standard-of-care therapies for brain cancer. The organizations is conducting preclinical studies to assess the efficacy and safety of THIO in combination with radiotherapy and immune checkpoint inhibitors in vitro and in vivo models. • In July 2022, we completed our selection process for the clinical sites for our Phase 2 study in Australia and Europe and our application to start the Phase 2 study in Australia has been approved. In July 2022, the first patient was administered with THIO in our Phase 2 human trial (THIO-101) in Australia. We have also submitted a similar application to conduct the same Phase 2 study in Europe. • On July 28, 2022, the Company’s shares of common stock began trading on the NYSE American under the symbol MAIA. On August 1, 2022, the Company sold 2,000,000 shares of common stock at $5.00 per share for net proceeds of $10,000,000 in an initial public offering prior to deducting underwriting discounts, commissions, and other offering expenses. On August 3, 2022, the Company sold an additional 300,000 shares of common stock at $5.00 per share when the underwriter exercised the overallotment for net proceeds of $1,500,000 prior to deducting underwriting discounts, commissions, and other offering expenses. We believe we have raised sufficient capital to fund the THIO-101 lead-in and preliminary efficacy of the phase 2 THIO-101 trial. • In December 2022, regulatory authorities in three European countries, Hungary, Poland, and Bulgaria, approved the implementation of THIO-101, MAIA’s Phase 2 clinical trial. THIO-101 is a critical component of THIO’s clinical development process and it is of the utmost importance that we collaborate with leading cancer institutes in Australia and now in Europe, for a target total of 30 clinical trial sites in six countries. • In December 2022, we completed a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) for the planned U.S. expansion of the THIO-101 Phase 2 trial evaluating THIO, an investigational telomere-targeting agent, in patients with advanced non-small cell lung cancer (NSCLC). • In the first week of March 2023, the first two patients were dosed in Europe in MAIA’s Phase 2 clinical trial, THIO-101 evaluating THIO in patients with advanced Non-Small Cell Lung Cancer (NSCLC). Following regulatory clearances in Hungary, Poland, and Bulgaria, five clinical sites have been activated in these three European countries. Impact of the COVID-19 Pandemic on Our Operations On January 30, 2020, the World Health Organization (“WHO”) announced a global health emergency because of a new strain of coronavirus originating in Wuhan, China (the “COVID-19 Outbreak”) and the risks to the international community as the virus spreads globally beyond its point of origin. In March 2020, the WHO classified the COVID-19 Outbreak as a pandemic, based on the rapid increase in exposure globally. The full impact of the COVID-19 Outbreak continues to evolve as of the date of this report. As a result, we cannot estimate the full magnitude that the pandemic will have on our business. If the COVID-19 Outbreak continues, it may have a material adverse effect on our financial condition, liquidity, and future results of operations for the future. We are actively monitoring the impact of the global pandemic on our financial condition, liquidity, operations, industry, and workforce. Given the daily evolution of the COVID-19 Outbreak and the global responses to curb its spread, we are not able to estimate the effects of the COVID-19 Outbreak on our results of operations, financial condition, or liquidity for the future. One of our initial clinical studies is taking place in Australia, which initially imposed one of the strictest COVID-19-related measures, including lock-downs. While we are not currently experiencing any delays or increased costs as a result of these measures, we may do so in the future. Impact of the War in Ukraine on Our Operations The short and long-term implications of Russia’s invasion of Ukraine are difficult to predict at this time. The imposition of sanctions and counter sanctions may have an adverse effect on the economic markets generally and could impact our business, financial condition, and results of operations. Because of the highly uncertain and dynamic nature of these events, the Company terminated any planned research activities in Russia. 82 Financial Operations Overview and Analysis For the Years Ended December 31, 2022 and 2021 Comparison of the Years Ended December 31, 2022 and 2021 Year Ended December 31, Change 2022 2021 Dollars Percentage Operating expenses: Research and development expenses $ 8,933,314 $ 3,496,796 $ 5,436,518 155% General and administrative expenses 6,143,527 4,289,831 1,853,696 43% Ratchet share expense 1,099,360 — 1,099,360 100% Total operating costs and expenses 16,176,201 7,786,627 8,389,574 108% Loss from operations (16,176,201 ) (7,786,627 ) (8,389,574 ) 108% Other income (expense): Interest expense (6,967 ) (827,539 ) 820,572 (99)% Interest income 1,870 2,012 (142 ) (7)% Australian research and development incentives 313,625 43,666 269,959 618% Paycheck protection program loan forgiveness — 62,500 (62,500 ) (100)% Change in fair value of embedded features — (203,000 ) 203,000 (100)% Change in fair value of warrant liability 98,394 (1,546,280 ) 1,644,674 (106)% Loss on extinguishment of convertible notes and convertible notes, related parties — (2,322,943 ) 2,322,943 (100)% Other income (expense), net 406,922 (4,791,584 ) 5,198,506 (108)% Net loss (15,769,279 ) (12,578,211 ) (3,191,068 ) 25% Net loss attributable to noncontrolling interests — (74,331 ) 74,331 (100)% Deemed dividend on warrant modifications (450,578 ) — (450,578 ) 100% Net loss attributable to MAIA Biotechnology, Inc. shareholders $ (16,219,857 ) $ (12,503,880 ) $ (3,715,977 ) 30% Operating Expenses Research and development expenses Research and development expenses increased by approximately $5,437,000 or 155%, from approximately $3,497,000 for the year ended December 31, 2021 to approximately $8,933,000 for the year ended December 31, 2022. The increase was primarily related to an increase in payroll and bonus expense of approximately $2,244,000 related to increased headcount of nine additional employees during the fiscal year 2022, the increase in clinical expenses related to the clinical trial startup of THIO of approximately $1,979,000, an increase in Scientific pre-clinical research of approximately $1,127,000, an increase in professional fees of approximately $18,000, and an increase in other expenses related to research and development of approximately $116,000 offset by a decrease in stock based compensation costs of approximately $47,000 related to employee options granted during fiscal year 2022. General and administrative expenses General and administrative expenses increased by approximately $1,854,000 or 43% from approximately $4,290,000 for the year ended December 31, 2021 to approximately $6,144,000 for the year ended December 31, 2022. The increase was primarily attributable to the increased costs to create additional infrastructure to support our operations as a public company. Increases included an increases in payroll and bonus expense of approximately $929,000 related to the increase in head count over the same period last 83 year, the approximate increase in other expenses of $896,000 and an increase of approximately $358,000 in professional fees offset by decrease in stock based compensation expense of approximately $329,000 primarily due to the 2021 expense related to founder's stock-based compensation expense. Ratchet Expense Ratchet expense increased by approximately $1,099,000 or 100% for the year ended December 31, 2022 due to the issuance of ratchet shares to certain private investors that purchased shares of our common stock prior to our initial public offering. Other income (expense), net Other income (expense), net increased approximately $5,199,000 from other expense of approximately $4,792,000 for the year ended December 31, 2021 to other income of approximately $407,000 for the year ended December 31, 2022. The increase in other income (expense), net was primarily the result of a loss on extinguishment of convertible notes and convertible notes of approximately $2,323,000 in 2021, approximately $1,645,000 of expense for the change in fair value of the warrant liability, the change in the fair value of bifurcated embedded feature of $203,000, expense related to approximately $828,000 of interest for convertible notes for the year ended December 31, 2021, and other income increased by approximately $270,000 of income related to the Australian research and development incentives for the year ended December 31, 2022 offset by a decrease in other income of approximated $63,000 for the paycheck protection loan forgiveness for the year ended December 31, 2021 and offset by the approximate $7,000 of interest expense for the year ended December 31, 2022. Liquidity and Capital Resources The following table presents selected financial information and statistics as of and for the years ended December 31, 2022 and 2021: Years Ended December 31, 2022 and 2021 As of December 31, 2022 2021 Balance Sheet Data: Cash 10,950,927 $ 10,574,592 Working capital (1) 8,539,131 8,526,499 Total assets 12,022,040 11,327,199 Accrued bonus 1,094,582 384,750 Deferred compensation — 111,271 Total stockholders' equity 8,507,793 9,181,203 (1) We define working capital as current assets less current liabilities. Capital Resources Our Ability to Continue as a Going Concern As of December 31, 2022, our available cash totaled approximately $10,951,000 which represented an increase of approximately $376,000 compared to December 31, 2021. As of December 31, 2022, we had working capital of approximately $8,539,000 which represents an increase of approximately $13,000 compared to December 31, 2021. We have generated no revenues as of December 31, 2022. The Company’s current operating plan indicates that it will continue to incur losses from operations and generate negative cash flows from operating activities given ongoing expenditures related to the completion of its ongoing clinical trials and the Company’s lack of revenue generating activities. Based on the Company’s cash reserves as December 31, 2022 of $10.95 million and current financial condition as of the date of the Annual Report on Form 10-K, the accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. To meet the Company’s future working capital needs, the Company will need to raise additional equity or enter into debt financing. While the Company has historically been able to raise additional capital through issuance of equity and/or debt financing, and while the Company has implemented a plan to control its expenses in order to satisfy its obligations due within one year from the date of issuance of these financial statements, the Company cannot guarantee that it will be able to raise additional equity, raise debt, or contain expenses. Accordingly, there is substantial doubt about the Company’s ability to continue as a going concern within one year after these financial statements are issued. Sale of Common Stock 84 During January and February 2022, the Company sold 263,729 shares of common stock at $9 per share for gross proceeds of $2,373,561 before transaction costs and expenses. Between April 22, 2022 and May 3, 2022, warrant holders exercised warrants, resulting in the issuance of 153,000 shares of common stock for proceeds of approximately $275,400. On May 19, 2022, the Company sold 11,111 shares of common stock at $9.00 per share for gross proceeds of $99,999 with no transaction costs. On August 1, 2022, the Company sold 2,000,000 shares of common stock at $5 per share for gross proceeds of $10,000,000 in an initial public offering. On August 3, 2022, the Company sold an additional 300,000 shares of common stock at $5 per share for gross proceeds of $1,500,000 per the overallotment option for the underwriter. We will need to raise additional capital to fund our operations, to develop and commercialize THIO, and to develop, acquire or in-license other products. We may seek to fund our operations through public equity, private equity, or debt financings, as well as other sources. We cannot make any assurances that additional financings will be available to us and, if available, on acceptable terms or at all. This could negatively impact our business and operations and could also lead to the reduction of our operations. Cash Flows Cash Flows years ended December 31, 2022 and 2021 Years Ended December 31, 2022 2021 Net cash flows used in operating activities $ (11,655,725 ) $ (4,122,896 ) Net cash flows provided by financing activities 12,036,790 14,033,731 Effect of foreign currency exchange rate changes on cash (4,430 ) — Net increase in cash and cash equivalents $ 376,635 $ 9,910,835 Operating Activities For the year ended December 31, 2022, net cash used in operating activities was approximately $11,657,000, which consisted of a consolidated net loss of approximately $15,769,000 offset by non-cash charges of approximately $3,320,000 which primarily includes approximately $2,319,000 in stock-based compensation, approximately $1,099,000 of expense related to the ratchet share issuance, offset by a gain of approximately $98,000 related to the changes in fair value of the warrant liability. Total changes in operating assets and liabilities of approximately $793,000 were primarily driven by an approximate $211,000 increase in accounts payable, and an approximate $1,027,000 increase in accrued expenses and an approximate $440,000 decrease in deferred offering costs offset by an approximate $111,000 decrease in deferred compensation, an approximate increase of $269,000 in Australian research and development incentives receivable and an approximate $505,000 increase in prepaid expenses and other current assets. For the year ended December 31, 2021, net cash used in operating activities was approximately $4,123,000, which consisted of a consolidated net loss of approximately $12,578,000 offset by non-cash charges of approximately $7,330,000 which primarily includes approximately $2,723,000 in stock-based compensation, a loss of approximately $203,000 related to the change in fair value of embedded features related to convertible notes, a loss of approximately $1,546,000 related to the changes in the fair value of the warrant liability, and amortization of debt discount on convertible notes of approximately $597,000, offset by a gain from forgiveness of Payroll Protection Plan loan of approximately $63,000. Total changes in operating assets and liabilities of approximately $1,126,000 were primarily driven by an approximate $806,000 increase in accounts payable, and an approximate $1,261,000 increase in accrued expenses, offset by an approximate $7,000 decrease in related party payables, an approximate $15,000 increase in prepaid expenses and other current assets, an approximate $264,000 increase in deferred compensation, and an approximate $652,000 increase in deferred offering costs. Financing Activities Net cash provided by financing activities for the year ended December 31, 2022 was approximately 12,037,000 consisted primarily of gross proceeds from the sale of common stock in the initial public offering of approximately $11,500,000, net proceeds from issuance of common stock of approximately of $2,474,000 in a crossover round, and proceeds from issuance of common stock upon exercise of warrants of approximately $385,000 and stock options of approximately $84,000 offset by approximately $2,406,000 of the offering costs paid in the year ended December 31, 2022. Net cash provided by financing activities for the year ended December 31, 2021 was approximately $14,034,000 which consisted primarily of proceeds from issuance of convertible notes totaling approximately $7,369,000, collections of subscriptions receivable of approximately $322,000 for MAIA, proceeds from issuance of common stock (net of transaction costs) of approximately $5,742,000, proceeds from the paycheck protection program loan totaling $63,000, proceeds from exercise of warrants of approximately $529,000 for MAIA, and proceeds from exercise of stock options of approximately $9,000 for MAIA. 85 Critical Accounting Policies and Significant Judgments and Estimates Management’s discussion and analysis of our financial condition and results of our operations is based on our consolidated financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The most significant estimates in the Company’s financial statements relate to the valuation of stock options and warrants and accruals for outsourced research and development activities. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected. We define our critical accounting policies as those accounting principles that require it to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles. While our significant accounting policies are more fully described in Note 1 to our financial statements, we believe the following are the critical accounting policies used in the preparation of its financial statements that require significant estimates and judgments. Stock-based compensation Our stock-based awards are classified as equity (restricted stock awards, and stock options, and warrants). We recognize related stock-based compensation expense based on the grant date fair value of the awards. The fair value of restricted stock awards is based on the trading value of the Company's common stock. We estimate the fair value of stock options and warrants using the Black-Scholes-Merton valuation model which requires the use of subjective assumptions that could materially impact the estimation of fair value and related compensation expense to be recognized. One of these assumptions include the expected volatility of our stock price. Developing this assumption requires the use of judgment. The Company lacks company-specific historical and implied volatility information. Therefore, we estimate our expected stock volatility based on the historical volatility of a publicly traded set of peer companies. Two of the assumptions used in the Black-Scholes-Merton valuation model are historical volatility and fair value of common stock. Historical volatility is subject to uncertainty due to changes in the market over time. The fair value of our common stock is subject to uncertainty due to the possibility of changes in the results of our clinical trials, which could impact the fair value of our common stock. The total expense related to stock options is material to our financial statements on an annual basis, and significant fluctuations in the volatility assumption or the fair value of our common stock could result in material changes in related compensation expense to be recognized. Prepaid and Accrued Research and Development Expenses As part of the process of preparing our consolidated financial statements, we are required to estimate our prepaid and accrued research and development expenses. This process involves reviewing open contracts and purchase orders, communicating with our personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of the actual cost. We make estimates of our prepaid and accrued research and development expenses as of each balance sheet date in our financial statements based on facts and circumstances known to us at the time. We confirm the accuracy of estimates with the service providers and make adjustments if necessary. Examples of estimated prepaid and accrued research and development expenses include expenses for: • Clinical Research Organizations (CROs) in connection with clinical studies; • Investigative sites in connection with clinical studies; • Vendors in connection with preclinical development activities; and • Vendors related to product manufacturing, development and distribution of clinical materials. We base our expenses related to clinical studies on our estimates of the services received and efforts expended pursuant to contracts with multiple CROs that conduct and manage clinical studies on our behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. The scope of services under these contracts can be modified and some of the agreements may be canceled by either party upon written notice. There may be instances in which 86 payments made to our vendors will exceed the level of services provided and result in a prepayment of the clinical expense. Payments under some of these contracts depend on factors such as the successful enrollment of subjects and the completion of clinical study milestones. In accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from our estimate, we adjust the accrual or prepaid accordingly. Although we do not expect our estimates to be materially different from amounts actually incurred, if our estimates of the status and timing of services performed differ from the actual status and timing of services performed we may report amounts that are too high or too low in any particular period. To date, there have been no material differences between our estimates and the amount actually incurred. Item 7A . Quantitative and Qualitative Disclosures About Market Risk. We are a smaller reporting company, as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required by this Item. Item 8 . Financial Statements and Supplementary Data. Beginning on page F-2 are the consolidated financial statements with applicable notes and the related Report of Independent Registered Public Accounting Firm. Item 9 . Changes in and Disagreements With Accountants on Accounting and Financial Disclosure. None.