Savara(US:SVRA)2021-03-10 14:35PART I Business Overview Savara Inc. is a biopharmaceutical company focused on rare lung diseases, with inhaled molgramostim for aPAP in Phase III development Business Overview - Savara Inc. is a company focused on rare lung diseases, with its main project, molgramostim inhaled solution (formerly Molgradex), an inhaled granulocyte-macrophage colony-stimulating factor (GM-CSF), currently in Phase III development for autoimmune pulmonary alveolar proteinosis (aPAP)12 Corporate Strategy - The company aims to be a leader in rare lung disease treatment by developing and commercializing innovative, best-in-class drugs to address unmet medical needs13 - Key strategic elements include: * Advancing the molgramostim aPAP program and the Phase III IMPALA 2 clinical trial, expected to launch by the end of Q2 2021 * Ensuring all manufacturing processes are validated for commercial scale and seeking a second molgramostim manufacturer to mitigate risk * Outsourcing capital-intensive operations to achieve efficient, capital-saving pipeline development through high-quality specialized vendors and consultants16 Molgramostim – aPAP - Autoimmune pulmonary alveolar proteinosis (aPAP) is a rare lung disease, accounting for approximately 90% of all PAP patients, characterized by surfactant accumulation in the alveoli, stemming from an autoimmune response against GM-CSF27 - Current standard treatment for aPAP is whole lung lavage (WLL), an invasive procedure that may only provide temporary symptom relief, with no approved drug therapies currently available2930 - Molgramostim, an inhaled formulation of non-glycosylated recombinant human GM-CSF, has received FDA Orphan Drug, Fast Track, and Breakthrough Therapy designations, and is used in some European countries for designated patients3436 - Key advantages of molgramostim include: * A solid product foundation combining an approved active drug class with drug delivery technology * Direct pulmonary delivery of GM-CSF, potentially achieving high clinical efficacy with limited systemic side effects * An efficient nebulizer providing rapid and convenient administration suitable for long-term treatment of chronic aPAP * Market protection through Orphan Drug status, potential biologics exclusivity, and Fast Track and Breakthrough Therapy designations * Proprietary cell banks for drug substance manufacturing and exclusive device agreements for optimized molgramostim inhaled solution delivery42 - The Phase III IMPALA trial did not meet its primary endpoint (improvement in alveolar-arterial oxygen gradient (A-a)DO2), but data showed molgramostim exhibited statistically significant or favorable trends in secondary and exploratory endpoints, including significant improvements in SGRQ and DLCO, and sustained treatment effects during the open-label period141741434649 - IMPALA 2 is a new 48-week, randomized, double-blind, placebo-controlled Phase III clinical trial comparing the efficacy and safety of molgramostim 300 µg once daily inhalation versus placebo, with the primary endpoint being change in DLCO percent predicted from baseline, expected to launch by Q2 2021 and yield top-line data in Q2 20245253 Molgramostim – NTM - Molgramostim was previously studied for non-tuberculous mycobacteria (NTM) lung infections in cystic fibrosis (CF) and non-CF patients; the OPTIMA trial did not meet its primary endpoint, and the ENCORE trial was discontinued due to COVID-19 and new CFTR modulator availability181920 - Based on OPTIMA and ENCORE trial results, the company decided to discontinue further development of molgramostim for NTM-related indications, focusing resources on aPAP as its primary indication21 Vancomycin hydrochloride inhalation powder - Vancomycin hydrochloride inhalation powder (AeroVanc) was the first inhaled antibiotic developed for persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infections in CF patients, but its Phase III AVAIL clinical trial did not meet its primary endpoint (absolute change from baseline in FEV1 percent predicted)2223 - Based on AVAIL trial results, the company has discontinued further development of the vancomycin program24 Inhaled liposomal ciprofloxacin ("Apulmiq") - The company previously entered into an exclusive license and collaboration agreement with Grifols, S.A. for global development and commercialization rights to Apulmiq (inhaled liposomal ciprofloxacin) for non-cystic fibrosis bronchiectasis (NCFB)25 - As part of its December 2020 pipeline rationalization strategy, the company has discontinued the clinical development program for Apulmiq, concentrating resources on molgramostim development for aPAP and the IMPALA 2 trial2675 Manufacturing and Supply - The company does not own or operate manufacturing facilities, instead outsourcing molgramostim production and supply through contracts with GEMA Biotech S.A. (drug substance), Patheon UK Limited (drug product), and PARI Pharma GmbH (eFlow® nebulizer system)55565758 - The company plans to seek a second drug substance manufacturer to mitigate production risks and ensure drug substance supply55 Commercialization - Savara holds exclusive rights to molgramostim in the U.S. and all other major markets, planning independent commercialization in the U.S. while potentially seeking strategic partners in the EU and other regions59 Key License and Other Agreements - A Master Services Agreement (MSA) with Parexel International (IRL) Limited stipulates Parexel will provide contract research services for the IMPALA 2 clinical trial, with estimated costs of approximately $31 million60 - A license and collaboration agreement with PARI Pharma GmbH grants exclusive global rights to the eFlow nebulizer system for pulmonary delivery of hGM-CSF in aPAP, with milestone and sales royalty payment obligations616364 - A manufacturing and supply agreement with GEMA Biotech S.A. designates GEMA as the exclusive supplier of molgramostim's active pharmaceutical ingredient (API), transferring master and working cell banks, with the company obligated to pay milestones and sales royalties6769 - A Master Manufacturing Services Agreement with Patheon UK Limited assigns Patheon responsibility for producing molgramostim clinical trial materials and future commercial supply7172 Government Regulation - Drug development and commercialization are subject to strict regulation by the FDA and international regulatory bodies, encompassing preclinical and clinical trials, BLA submission and review, and post-market requirements7677 - Expedited approval pathways include: * Fast Track Designation: For new drugs treating serious or life-threatening conditions that address unmet medical needs * Accelerated Approval: Based on surrogate or intermediate clinical endpoints for BLA approval * Breakthrough Therapy Designation: For drugs treating serious or life-threatening conditions with preliminary clinical evidence suggesting substantial improvement over existing therapies; molgramostim has received this designation878896 - Orphan Drug Designation grants drugs for rare diseases 7 years (U.S.) and 10 years (EU) of market exclusivity, tax credits, and BLA application fee waivers, but carries the risk of a competing product gaining prior approval909294 - Post-market products must continuously comply with FDA regulations for record-keeping, adverse event reporting, cGMP, and advertising, with violations potentially leading to product recalls, approval withdrawal, or fines9799100 - Molgramostim, as a drug-device combination product, will be primarily regulated by the FDA's Center for Drug Evaluation and Research (CDER)101 - The company must also comply with healthcare laws and compliance requirements such as the Federal Anti-Kickback Statute, False Claims Act, HIPAA privacy laws, Sunshine Act (Open Payments), and the Foreign Corrupt Practices Act (FCPA)102103104105107110 - Drug sales coverage and reimbursement are significantly influenced by third-party payers (government healthcare programs, managed care, private insurance), who increasingly challenge drug prices and cost-effectiveness, potentially limiting product market acceptance and revenue111 - The Affordable Care Act and subsequent legislation (e.g., the Budget Control Act of 2011) have significantly impacted the healthcare system, including increased drug rebates and Medicare payment cuts, with future reforms potentially further affecting company profitability113114115116 Intellectual Property - The company protects its technology through patents, trade secrets, and proprietary know-how; molgramostim lacks patent protection for aPAP treatment, relying primarily on Orphan Drug exclusivity, proprietary delivery devices, and proprietary cell banks118228 - The company previously held patents for a proprietary vancomycin formulation, but with the discontinuation of that project, it may abandon related patent applications in the future119233 - The patent application and maintenance process is complex and expensive, with risks of patents being challenged, invalidated, or circumvented; trade secret protection also faces risks of disclosure or independent discovery231232234 Competition - The pharmaceutical industry is highly competitive, with the company facing rivals such as large pharmaceutical and biotechnology companies, specialty pharmaceutical companies, and academic institutions, which often possess greater resources and experience124249 - Currently, no other companies are developing inhaled GM-CSF, but the injectable GM-CSF product sargramostim (Leukine®) is used off-label for aPAP, and its manufacturer has obtained aPAP Orphan Drug designation, potentially posing a competitive threat in Japan125208 Employees and Human Capital - As of March 8, 2021, the company had 27 employees, with 14 in Denmark and 13 in the U.S. The company is committed to attracting and retaining highly skilled talent through competitive compensation, training, and a focus on diversity and inclusion126127128130 - During the COVID-19 pandemic, the company prioritized employee health and safety, implemented remote work, and enhanced internal communication131 Merger and Corporate Information - Savara completed its business combination on April 27, 2017, through a reverse merger with Mast Therapeutics, Inc. The company's website provides SEC filings132133 Risk Factors The company faces multiple risks in financing, product development, intellectual property, market competition, and regulatory compliance Summary Risk Factors - Key risks include: * Ongoing losses and future financing needs * Reliance on molgramostim's clinical, regulatory, and commercial success * Dependence on third-party manufacturers and CROs * Potential for adverse side effects from products * Challenges in intellectual property protection * Intense market competition * Uncertainties in healthcare reform and reimbursement policies * Product liability risks and stock price volatility137139140141142 Risks Relating to Our Capital Requirements and Financial Condition - The company has incurred continuous losses since inception, with a net loss of $49.6 million in 2020 and an accumulated deficit of $257.5 million; significant operating losses are expected in the coming years, requiring additional financing for molgramostim's clinical development and commercialization143144145146 Key Financial Data for 2020 and 2019 | Metric | 2020 (Million USD) | 2019 (Million USD) | | :--- | :--- | :--- | | Net Loss | (49.6) | (78.2) | | Cash Used in Operating Activities | (39.8) | (45.1) | | Cash, Cash Equivalents, and Short-Term Investments (Period End) | 82.2 | 121.8 | | Accumulated Deficit (Period End) | (257.5) | (207.9) | - The company's loan agreement contains restrictive covenants, where failure to meet specific milestones (e.g., first patient dosed in the IMPALA 2 trial) could trigger immediate debt maturity or accelerated principal payments149317318 - The company holds significant in-process research and development (IPR&D) intangible assets, which may be impaired in the future due to poor clinical trial results, unfavorable regulatory outcomes, or increased development costs, materially impacting financial condition; goodwill was fully impaired in 2019153154 Risks Related to Our Business Strategy and Operations - The company's business is highly dependent on molgramostim's clinical, regulatory, and commercial success; the IMPALA trial did not meet its primary endpoint, and the FDA previously indicated insufficient data, though the new IMPALA 2 trial design has regulatory acceptance, clinical trial outcomes remain inherently uncertain156158159160162 - The company's success relies on attracting and retaining senior management and key scientific personnel; the loss of key employees could delay product development and commercialization165166167 - The company is entirely dependent on third parties for the manufacturing and supply of clinical trial drugs and delivery devices; loss of a supplier or failure to provide adequate supply in a timely manner could severely harm the business; the company is seeking a second molgramostim manufacturer170172 - The company heavily relies on third parties (e.g., CRO Parexel) for non-clinical testing and clinical trials; failure of third parties to satisfactorily perform contractual obligations or meet expected timelines could adversely affect molgramostim's development177178180186 - Molgramostim may cause adverse side effects or events, potentially interrupting, delaying, or halting clinical development, regulatory approval, or commercialization181 - The company may fail to achieve anticipated development goals within announced timeframes, potentially leading to increased development costs or project termination183184 - Third-party computer system failures, cyberattacks, or cybersecurity flaws could lead to business interruptions, data loss, or breaches, adversely affecting company operations and financial results; remote work during the COVID-19 pandemic increased cybersecurity risks188189 - Failure to comply with data protection laws and regulations (e.g., GDPR and CCPA) could result in government enforcement actions, significant fines, and negative publicity192 - Natural disasters, war, system failures, terrorism, telecommunications and power outages, or other catastrophic events, as well as public health crises like COVID-19, could disrupt company operations and adversely affect financial results193194195 - The company currently has limited marketing capabilities and no sales organization; inability to establish sales and marketing capabilities independently or through third parties will prevent successful product commercialization or revenue generation196 - To establish sales and marketing infrastructure and expand manufacturing capacity, the company will need to expand its organizational size, potentially facing difficulties in managing growth197198 Risks Related to Drug Development and Commercialization - The company relies on the successful completion of clinical trials for its molgramostim product candidate, but positive past clinical trial results do not guarantee future success; clinical trials are expensive, time-consuming, and uncertain, potentially delayed or failed by various factors199200203205211212213214 - Molgramostim has received FDA and European Orphan Drug designations; if a competitor obtains Orphan Drug exclusivity for a product with the same active ingredient and delivery route, the company may be unable to sell its product until the competitor's exclusivity expires204 - The regulatory approval process involves significant uncertainty, potentially requiring further testing and validation, and approvals may be subject to conditions, delays, or rejections, severely harming the company's business215216217218219220 - Even if a product receives regulatory approval, if it fails to gain widespread market acceptance by the medical community, patients, or third-party payers, sales revenue will be limited, and the company may not achieve profitability222223224 - Even with regulatory approval in the U.S., the company may be unable to obtain approval or commercialize products in other countries, which would limit the full commercial potential of its products226 - The company must comply with the U.S. Foreign Corrupt Practices Act and similar foreign anti-corruption laws, with violations potentially leading to business disruptions227 Risks Related to Our Intellectual Property - The company's success depends on obtaining and maintaining effective intellectual property protection for its main product candidates and proprietary technology; molgramostim lacks patent protection for aPAP treatment, relying primarily on Orphan Drug exclusivity228 - Patent protection may be difficult to obtain, granted claims may be limited in scope, and patents may be challenged, invalidated, or circumvented by competitors231237239240 - Obtaining and maintaining patent protection relies on compliance with various procedural, filing, and fee payment requirements of government patent agencies; non-compliance could lead to reduced or lost patent rights242 - Third parties may claim the company's products infringe their proprietary rights and may challenge product use or patent rights through litigation or administrative proceedings; defending such actions can be costly, time-consuming, and divert management's attention243244246 Risks Related to Our Industry - The biopharmaceutical industry in which the company operates is highly competitive and rapidly changing; even if approved, molgramostim will face competition and may be unable to successfully compete with larger pharmaceutical companies possessing greater resources248249 - Healthcare reform measures and reimbursement policy uncertainties could hinder or prevent the commercial success of the company's products; third-party payer challenges to drug prices and cost-effectiveness, along with government cost control measures, could limit company revenue and profitability250251252253 - The company faces potential product liability risks; successful claims could result in substantial liability and may require limiting product commercialization; obtaining additional or increased product liability insurance in the future is uncertain254255256 Risks Related to our Common Stock - The company's common stock price is expected to remain volatile, influenced by factors such as clinical trial results, regulatory approvals, commercial success, financing capabilities, competition, intellectual property disputes, key personnel changes, and macroeconomic conditions257259260 - If the company fails to meet all applicable Nasdaq continued listing requirements (including the minimum $1.00 closing bid price requirement), its common stock may be delisted, adversely affecting stock liquidity and market price262263 - As a public company, the company will continue to incur compliance costs and administrative requirements, and does not anticipate paying cash dividends in the foreseeable future264266 - Certain transactions completed by the company may result in an ownership change under Section 382 of the Internal Revenue Code, limiting the use of net operating loss carryforwards and other tax attributes267 Unresolved Staff Comments The company currently has no unresolved comments from SEC staff - The company currently has no unresolved comments from SEC staff268 Properties The company's headquarters are in Austin, Texas, with leased office space in Copenhagen, Denmark, and existing facilities are deemed adequate - The company's headquarters are in Austin, Texas, leasing approximately 6,151 square feet of office space with a lease expiring in July 2021; additionally, the company leases office space in Copenhagen, Denmark, where approximately 50% of its employees are based269 - The company believes its existing facilities are adequate for short-term use and is confident that suitable alternative space can be obtained on commercially reasonable terms if needed in the future270 Legal Proceedings The company is not currently involved in any material pending litigation or other significant legal proceedings - The company is not currently involved in any material pending litigation or other significant legal proceedings; litigation could adversely affect the company due to defense and settlement costs and diversion of management resources271 Mine Safety Disclosures This item is not applicable - This item is not applicable272 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, with approximately 125 record holders as of March 8, 2021 - The company's common stock trades on the Nasdaq Global Select Market under the ticker symbol “SVRA”274 - As of March 8, 2021, the company had approximately 125 record holders of common stock, with the number of beneficial owners being significantly greater274 Management's Discussion and Analysis of Financial Condition and Results of Operations. The company reports continuous losses and a substantial accumulated deficit, requiring significant future capital for its clinical development Overview - Savara Inc. is a company focused on rare lung diseases, with its main project, molgramostim inhaled solution, in Phase III development for autoimmune pulmonary alveolar proteinosis (aPAP)278 - The company has been in a loss position since inception, with no product revenue; as of December 31, 2020, the accumulated deficit was $257.5 million279280 Net Loss for 2020 and 2019 | Metric | 2020 (Million USD) | 2019 (Million USD) | | :--- | :--- | :--- | | Net Loss | (49.6) | (78.2) | - The company anticipates incurring significant operating losses for the foreseeable future, requiring substantial additional capital to fund operations281282 Recent Events - On March 5, 2021, the company entered into a Master Services Agreement with Parexel, which will provide contract research services for the IMPALA 2 clinical trial, with estimated costs of approximately $31 million283 - On December 10, 2020, the company announced the Phase III trial for vancomycin hydrochloride inhalation powder did not meet its primary endpoint, and on January 7, 2021, issued a termination notice to GlaxoSmithKline Trading Services Limited (GSK), with termination costs less than $1 million284 - The COVID-19 pandemic has created uncertainty for aPAP patient populations and physicians, potentially delaying clinical trial enrollment and negatively impacting the company's supply chain and development timelines285287 Income Taxes - The CARES Act provided several tax relief measures in response to the COVID-19 pandemic, including removing the 80% taxable income limitation for net operating losses (NOLs) and allowing NOLs to be carried back five years, but the company believes these measures have no material impact on its tax reporting288290291 Critical Accounting Policies and Estimates - The company makes significant estimates and judgments in preparing its financial statements, including research and development expense accruals, business combinations, impairment of goodwill and acquired in-process research and development (IPR&D), stock-based compensation expense, product revenue, milestone revenue, and income taxes292 - Research and development expense accruals are based on estimated completion of services and agreed-upon fees from external service providers (e.g., CROs and CMOs); goodwill and IPR&D are tested for impairment annually, or more frequently if impairment indicators arise293294296299 - Stock-based compensation expense is estimated based on fair value at the grant date and recognized over the vesting period; product revenue is recognized using the five-step model under ASC 606, and milestone revenue is recognized as variable consideration upon satisfaction of performance obligations301302303304305 Financial Operations Overview - Research and development expenses are the largest component of the company's operating expenses, primarily comprising fees under agreements with CROs, consultants, and clinical trial sites, laboratory and vendor fees, contract manufacturing expenses, and internal R&D costs307 - General and administrative (G&A) expenses primarily include salaries and benefits for executive, finance, accounting, and legal personnel, as well as professional and consulting service fees309 - Other income (expense), net includes amortization of capitalized debt issuance costs and debt discounts, net interest income and expense, foreign currency transaction gains and losses, tax credit income, and gains and losses from changes in the fair value of financial instruments310 Results of Operations — Comparison of Years Ended December 31, 2020 and 2019 Results of Operations for 2020 and 2019 | Metric (Thousand USD) | 2020 | 2019 | Change | | :--- | :--- | :--- | :--- | | Milestone Revenue | 257 | — | 257 | | Research and Development Expenses | 35,038 | 38,781 | (3,743) | | General and Administrative Expenses | 14,264 | 13,081 | 1,183 | | Goodwill Impairment | — | 26,852 | (26,852) | | Depreciation | 255 | 311 | (56) | | Total Operating Expenses | 49,557 | 79,025 | (29,468) | | Operating Loss | (49,300) | (79,025) | 29,725 | | Other Income (Expense), Net | (315) | 852 | (1,167) | | Net Loss | (49,615) | (78,173) | 28,558 | - Research and development expenses decreased by $3.7 million (9.7%), primarily due to the termination of non-aPAP trials (particularly the vancomycin program), partially offset by Apulmiq-related costs312 - General and administrative expenses increased by $1.2 million (9.0%), primarily due to higher stock-based compensation, increased insurance costs, and costs related to the resignation of the former CEO and CCO, partially offset by reduced commercial costs for molgramostim product candidates313 - Goodwill impairment expense of $26.9 million was recognized in 2019, with no such expense in 2020314 - Other income (expense), net, shifted from $0.9 million income in 2019 to $0.3 million expense in 2020, primarily due to a $1.4 million increase in net interest expense, resulting from decreased investment income due to lower interest rates315 Liquidity and Capital Resources - As of December 31, 2020, the company's cash, cash equivalents, and short-term investments totaled $82.2 million, with an accumulated deficit of $257.5 million; the company anticipates high future R&D expenses, requiring funding through additional equity issuance and potential borrowings316335 - Debt Financing: * A loan and security agreement (as third amended) with Silicon Valley Bank provides $25 million in term debt financing * The third amendment extends the interest-only period for the loan until June 30, 2022, with principal and interest repaid in 18 equal monthly installments thereafter * If the company fails to initiate the molgramostim aPAP Phase III clinical trial by the end of Q2 2021, the interest-only period will end early, and principal plus interest will be repaid in 24 equal monthly installments starting April 1, 2021 * The loan is secured by all company assets and includes restrictive covenants, requiring the company to receive at least $25 million in gross cash proceeds from warrant exercises or equity issuances by June 30, 2021317318319 - Equity Financing: * Through an at-the-market common stock sales agreement with H.C. Wainwright & Co., LLC, the company may periodically sell up to $60 million of common stock; net proceeds of $2.3 million and $29.6 million were received in 2020 and 2019, respectively, through this agreement * A public offering completed in July 2018 yielded net proceeds of approximately $45.8 million * A private placement (PIPE) completed in December 2019 issued common stock and pre-funded warrants, generating gross proceeds of approximately $26.8 million, and issued milestone warrants with potential gross proceeds up to $48.2 million323324325327 Cash Flows for 2020 and 2019 | Cash Flow Category (Thousand USD) | 2020 | 2019 | | :--- | :--- | :--- | | Cash Used in Operating Activities | (39,836) | (45,123) | | Cash Provided by Investing Activities | 9,053 | 15,740 | | Cash Provided by Financing Activities | 3,689 | 54,908 | | Effect of Exchange Rate Changes | 170 | (22) | | Net Increase (Decrease) in Cash | (26,924) | 25,503 | | Cash and Cash Equivalents, End of Period | 22,880 | 49,804 | - The company anticipates requiring substantial additional capital in the foreseeable future to support ongoing clinical development and potential commercialization activities; failure to obtain timely financing could lead to delays, limitations, or termination of product development or commercialization efforts334335336337 Manufacturing and Other Commitments and Contingencies - The company is obligated to pay milestone payments and sales royalties under agreements with molgramostim API and nebulizer manufacturers; as of December 31, 2020, total unmet or unoccurred milestone commitments amounted to $8.432 million338447448450 Other Contracts - The company enters into service contracts with third parties for research, clinical trials, and testing in the ordinary course of business; these contracts typically provide for termination upon notice, so non-cancelable obligations are not materially impactful339 Recent Accounting Pronouncements - The company has reviewed and adopted several recent accounting pronouncements, including ASU 2018-13 (Fair Value Measurement), ASU 2018-18 (Collaborative Arrangements), ASU 2019-01 (Leases), and ASU 2019-08 (Stock-Based Compensation); these pronouncements have no material impact on the company's consolidated financial statements340451452453455 Quantitative and Qualitative Disclosures About Market Risk. The company faces interest rate risk on cash and investments, and foreign exchange risk from Danish and Eurozone operations, mitigated by derivatives - The company faces interest rate risk related to cash, cash equivalents, and short-term investments, but does not expect a material impact; the investment portfolio primarily consists of short-term, highly-rated fixed-income instruments341 - The company has operations in Denmark and uses derivative instruments and short-term foreign currency forward contracts to limit the impact of foreign exchange fluctuations; no significant foreign exchange losses were recognized in 2020 and 2019342 - The company's loan agreement with Silicon Valley Bank carries interest rate risk, with the loan rate tied to the Wall Street Journal Prime Rate; a 10% change in interest rates is not expected to materially impact the investment portfolio value or interest expense343 - The company believes inflation did not have a material impact on its results of operations during the reported periods344 Financial Statements and Supplementary Data. The required consolidated financial statements and supplementary information are submitted as exhibits to this report - The consolidated financial statements and supplementary financial information required by this item are submitted as exhibits to this report345 Changes in and Disagreements with Accountants on Accounting and Financial Disclosure. The company has experienced no changes in accountants or disagreements with accountants on accounting and financial disclosure - The company has experienced no changes in accountants or disagreements with accountants on accounting and financial disclosure346 Controls and Procedures. Management assessed disclosure controls and internal control over financial reporting as effective, with no independent audit required - As of December 31, 2020, the company's Chief Executive Officer and Chief Financial Officer evaluated and concluded that its disclosure controls and procedures were effective347 - Management assessed and concluded that the company's internal control over financial reporting was effective as of December 31, 2020348 - As a smaller reporting company, the company is not required to have an independent audit of the effectiveness of its internal control over financial reporting349 - There were no material changes in the company's internal control over financial reporting during the fourth quarter of 2020350 Other Information. This item is not applicable - This item is not applicable351 PART III Directors, Executive Officers and Corporate Governance. The company has adopted a code of ethics, with other required information incorporated by reference from the proxy statement - The company has adopted a code of ethics applicable to all executive officers, directors, and employees, published on its website355 - The other information required by this item will be incorporated by reference from the proxy statement356 Executive Compensation. The information required by this item will be incorporated by reference from the proxy statement - The information required by this item will be incorporated by reference from the proxy statement357 Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters. The information required by this item will be incorporated by reference from the proxy statement - The information required by this item will be incorporated by reference from the proxy statement358 Certain Relationships and Related Transactions, and Director Independence. The information required by this item will be incorporated by reference from the proxy statement - The information required by this item will be incorporated by reference from the proxy statement359 Principal Accounting Fees and Services. The information required by this item will be incorporated by reference from the proxy statement - The information required by this item will be incorporated by reference from the proxy statement360 PART IV Exhibits, Financial Statement Schedules. This report's exhibits include the independent auditor's report and consolidated financial statements, with all schedules omitted as inapplicable - The following documents are included as exhibits to this report: * Report of Independent Registered Public Accounting Firm * Consolidated Balance Sheets as of December 31, 2020 and 2019 * Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 2020 and 2019 * Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2020 and 2019 * Consolidated Statements of Cash Flows for the years ended December 31, 2020 and 2019 * Notes to Consolidated Financial Statements363366 - All financial statement schedules have been omitted because they are not applicable or the required information is presented in the financial statements or notes thereto364 Form 10-K Summary. This item is not applicable - This item is not applicable365