Ekso Bionics(EKSO) - 2022 Q4 - Annual Report

PART I Business Overview Ekso Bionics develops and markets exoskeleton products for medical rehabilitation (EksoHealth) and industrial applications (EksoWorks), expanding its medical portfolio with the HMC Acquisition - Ekso Bionics designs, develops, and markets exoskeleton products for medical (EksoHealth) and industrial (EksoWorks) applications, augmenting human strength, endurance, and mobility[15] - The company acquired the Human Motion and Control (HMC) Business Unit from Parker Hannifin Corporation on December 5, 2022, adding FDA-cleared lower-limb powered exoskeletons (Ekso Indego Therapy and Ekso Indego Personal) to its medical portfolio[17][332] - Medical Products (EksoHealth): - EksoNR: Robotic exoskeleton specifically designed for neurorehabilitation patients (ABI, stroke, MS, SCI), FDA-cleared for multiple conditions, offers natural gait retraining - Ekso Indego Therapy: Modular, adjustable, lightweight, lower-limb powered exoskeleton for rehabilitation and wellness applications (stroke, SCI patients) - Ekso Indego Personal: Lightweight powered lower limb orthosis for independent walking in home and community settings (SCI patients T3-L5) - Industrial Products (EksoWorks): - Ekso EVO: Wearable upper body exoskeleton for overhead work, designed to reduce worker fatigue and injuries while boosting productivity, targeted at aerospace, automotive, manufacturing, and specific construction trades - EksoVest & EksoZeroG: Predecessor products to EVO and a mobile tool support arm, respectively, both discontinued in 2022 - As of December 31, 2022, approximately 620 EksoNR and EksoGT units combined were shipped to over 400 rehabilitation facilities worldwide, and more than 300 Ekso Indego Therapy and Personal devices to over 220 clinical centers or personal end users[23] U.S. Patent Portfolio Summary (as of December 31, 2022) | Issuing Status | Patents | Applications | | :------------- | :------ | :----------- | | Licensed to the Company | 9 | 3 | | Exclusively licensed to the Company | 10 | — | | Co-owned with a third party, exclusively licensed to the Company | 5 | — | | Co-owned with a third party | 3 | — | | Sole ownership by the Company | 61 | 11 | | Total | 88 | 14 | Risk Factors The company faces significant business, financial, intellectual property, regulatory, product liability, and common stock ownership risks - Business and Operational Risks: - The ongoing COVID-19 pandemic has adversely affected financial condition and future certainty[128][129] - The markets in which products are sold are highly competitive and continue to develop[130][131] - Inability to reduce manufacturing or service costs as planned[132] - Production and supply chain disruptions (e.g., semiconductor shortages, increased lead times) could negatively impact the business[133][134] - Coverage policies and reimbursement levels of third-party payers may impact sales of products[136][137] - Long and variable sales cycles for products (EksoNR and Ekso Indego)[138][139] - International sales are subject to factors outside of the company's control[140] - Inability to enhance product offerings through research and development efforts or successfully integrate acquisitions[141][142] - Reliance on sales of EksoNR, Ekso Indego Therapy, and Ekso Indego Personal for a significant portion of revenue[143][144] - Dependence on independent distributors for sales and marketing in certain geographies[145][146] - Success depends on the management team and ability to hire, train, retain, and motivate employees[147][148] - Financial & Accounting Risks: - Significant accumulated losses ($223.9 million as of Dec 31, 2022) and anticipated future losses; may not achieve or maintain profitability[153][154] - Loan agreement imposes certain financial and operational restrictions[155] - May be unable to generate sufficient cash flow to service debt obligations (PWB Loan due Aug 2023, Promissory Note payments begin Dec 2023)[156][157] - May not have sufficient funds to meet future capital requirements, relying on external financing[158][159] - May not be able to leverage cost structure or achieve better margins[160] - Could fail to maintain effective internal control over financial reporting[161] - Intellectual Property Risks: - Protecting intellectual proprietary rights can be costly and success is not certain; patents may not provide meaningful protection or prevent competitors[163][164] - Intellectual property litigation and infringement claims could cause significant expenses or prevent product sales[165][166] - Some patents and patent applications are not within complete control (e.g., co-owned with UC Berkeley, licensed from Vanderbilt University), potentially reducing their value[167][168] - Legal and Regulatory Compliance Risks: - Failure to obtain or maintain necessary FDA/foreign regulatory clearances or approvals for medical device products, or delays in approvals, would harm commercial operations[176][177] - Modifications to products may require new 510(k) clearances or premarket approvals, or require cessation of marketing/recall[178][179] - Failure to meet strict post-market regulatory requirements (e.g., QSR) could result in fines, costs, or facility closures[180][181] - Fines, penalties, or injunctions if determined to be promoting unapproved or 'off-label' uses[182][183] - Adverse medical device reporting obligations, voluntary corrective actions, or agency enforcement actions[184][185] - Failure to comply with anti-kickback and fraud regulations could result in substantial penalties and changes in business operations[186][187] - Changes in law or regulation could make it more difficult and costly to manufacture, market, and distribute products or obtain/maintain regulatory approval[188][189] - Healthcare changes in the U.S. and other countries (e.g., ACA, cost containment programs) could negatively impact future operating results[190][191] - Failure to comply with HIPAA, HITECH Act, and implementing regulations could result in significant penalties[192][193] - Evolving laws, regulations, and obligations related to privacy, data protection, and information security (e.g., CCPA, CPRA, GDPR) pose compliance challenges and risks[194][195] - Cybersecurity risks to systems, infrastructure, and technology, and data processed by the company or third-party vendors[196][197] - Product Liability Risks: - Products may become subject to voluntary or involuntary recall due to deficiencies or defects, potentially causing severe injury or death[226][227] - Product liability insurance may not adequately cover potential claims or recalls[228][229] - Warranty claims and accelerated maintenance programs result in additional operating costs[230][231] - Risks Related to Ownership of Common Stock: - Future issuances of equity securities (compensatory equity awards, exercise of outstanding warrants, or financing transactions) may dilute stockholders and depress the market price of common stock[233][234] - The Board of Directors' ability to issue additional preferred stock may prevent difficult transactions, including a sale or merger[235][236] - The company has never paid and does not intend to pay cash dividends, meaning return on investment will only occur if the stock price appreciates[237][238] - The market price of common stock has been, and may continue to be, highly volatile, and trading is limited[239] Unresolved Staff Comments The company reported no unresolved staff comments from the SEC - No unresolved staff comments were reported[240] Properties Ekso Bionics operates principal offices and manufacturing in California, with additional facilities in Ohio and European headquarters in Germany, owning no real property - Principal executive offices and manufacturing: 101 Glacier Point, Suite A, San Rafael, California (approximately 17,000 square feet leased)[241] - Additional manufacturing: Macedonia, Ohio (leased from Parker Hannifin Corporation to support Ekso Indego product lines)[242] - European headquarters: Friesenweg 4, House 13, 4th floor, 22763 Hamburg, Germany (approximately 3,000 square feet leased)[242] - The company does not own any real property[242] Legal Proceedings The company is involved in ordinary course legal proceedings, with management believing no material adverse effect, despite inherent litigation uncertainties - The company is subject to various legal proceedings and claims arising in the ordinary course of business[243] - Management believes that the amount or range of reasonably possible losses will not, either individually or in the aggregate, have a material adverse effect on the company's business, results of operations, or financial condition[243] - The results of any litigation cannot be predicted with certainty, and an unfavorable resolution could materially affect future business, results of operations, or financial condition, regardless of defense and settlement costs and diversion of management resources[244] Mine Safety Disclosures This item is not applicable to the company - This item is not applicable[245] PART II Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Ekso Bionics' common stock trades on Nasdaq, with 13.3 million shares outstanding and no anticipated cash dividends, as future earnings will fund growth - Common stock (EKSO) has been traded on the Nasdaq Capital Market since August 9, 2016[247] Common Stock Information (as of March 23, 2023) | Metric | Value | | :----- | :---- | | Outstanding Shares | 13,341,505 | | Stockholders of Record | ~175 | | Closing Price | $1.47 | - The company has never declared or paid cash dividends on its common stock and does not anticipate such a declaration or payment for the foreseeable future, expecting to use future earnings, if any, to fund business growth[249] Reserved This item is reserved and contains no information - This item is reserved[253] Management's Discussion and Analysis of Financial Condition and Results of Operations This section reviews Ekso Bionics' 2022 financial performance, liquidity, and capital resources, highlighting revenue growth, declining gross profit, increased net loss, and critical accounting policies - Ekso Bionics designs, develops, and markets exoskeleton products that augment human strength, endurance, and mobility for medical (EksoHealth) and industrial (EksoWorks) applications[255] - EksoHealth: Focuses on medical applications, with EksoNR for neurorehabilitation and Ekso Indego Therapy/Personal (from HMC acquisition) for gait training and home use - EksoWorks: Focuses on industrial applications, with EVO for upper body support in overhead tasks, aiming to reduce fatigue and injuries. EksoVest and EksoZeroG were discontinued in 2022 - 2022 Operational and Financial Highlights: - Completed the HMC Acquisition, including the Indego product line - Booked a total of 100 EksoHealth device units in 2022 - Generated revenue of $12.9 million for the 2022 full year, an increase of 15% - Strong cash position of $20.5 million as of December 31, 2022 - Economic and industry trends, including growing supply chain issues, inflation, hospital financial pressures, and reimbursement levels, are impacting customers and could adversely affect the business[264][265] Consolidated Results of Operations (in thousands) | Metric | 2022 ($) | 2021 ($) | Change ($) | % Change | | :-------------------------- | :----- | :----- | :--------- | :------- | | Revenue | $12,912 | $11,246 | $1,666 | 15% | | Cost of revenue | 6,698 | 4,497 | 2,201 | 49% | | Gross profit | 6,214 | 6,749 | (535) | (8)% | | Gross profit % | 48% | 60% | | | | Sales and marketing | 7,157 | 7,305 | (148) | (2)% | | Research and development | 3,626 | 2,549 | 1,077 | 42% | | General and administrative | 10,987 | 10,723 | 264 | 2% | | Total operating expenses | 21,770 | 20,577 | 1,193 | 6% | | Loss from operations | (15,556) | (13,828) | (1,728) | 12% | | Total other income, net | 476 | 4,064 | (3,588) | (88)% | | Net loss | $(15,080) | $(9,764) | $(5,316) | 54% | - Revenue: Increased by $1.7 million (15%) in 2022, driven by a $2.1 million increase in EksoHealth revenue (due to higher device sales volume in Americas and EMEA, partially normalizing post-COVID-19), offset by a $0.4 million decrease in EksoWorks revenue (due to rescaling sales and marketing)[268][270] - Gross Profit & Margin: Gross profit decreased by $0.5 million (8%), and gross margin declined to 48% in 2022 (from 60% in 2021), primarily due to inflationary pressures, elevated labor costs, and lower average selling prices across both segments[271][273] - Operating Expenses: Sales and marketing decreased slightly (-2%) due to lower compensation. R&D increased significantly (+42%) due to product development and HMC acquisition headcount. G&A increased (+2%) due to compensation, severance, and relocation costs[274][275] - Other (Expense) Income, Net: Gain on revaluation of warrant liabilities decreased from $4.0 million in 2021 to $1.3 million in 2022. A $1.1 million gain on PPP loan forgiveness in 2021 had no comparable amount in 2022. Unrealized foreign exchange loss decreased from $0.9 million to $0.7 million[276][277][278] - Liquidity and Capital Resources: - Working capital decreased from $40.9 million (2021) to $21.8 million (2022) due to operating and investing cash outflows[279][280] - Cash on hand: $20.5 million (Dec 31, 2022), with $19.6 million domestic and $0.9 million foreign[281] - Accumulated deficit: $223.9 million (Dec 31, 2022)[283] - Net losses: $15.1 million (2022) and $9.8 million (2021)[285] - Net cash used in operating activities: $14.7 million (2022)[290] - $6.7 million available for future offerings under ATM Agreement (as of Dec 31, 2022)[291] - Secured term loan with Pacific Western Bank requires minimum cash on hand ($2.0 million restricted as of Dec 31, 2022) and matures August 2023[292] - Promissory Note to Parker Hannifin ($5.0 million) from HMC acquisition, with payments starting December 2023[292] Contractual Obligations and Commitments (in thousands, as of Dec 31, 2022) | Obligation | Total ($) | Less than one year ($) | 1-3 Years ($) | 3-5 Years ($) | | :---------------------- | :---- | :----------------- | :-------- | :-------- | | Term loan | $2,107 | $2,107 | $— | $— | | Promissory Note | 5,000 | 313 | 2,500 | 2,187 | | Facility operating leases | 1,578 | 408 | 821 | 349 | | Purchase obligations | 3,480 | 3,480 | — | — | | Total | $12,165 | $6,308 | $3,321 | $2,536 | - Critical Accounting Policies and Estimates: - Standalone Selling Prices: Estimates for allocating revenue in multi-element arrangements[296] - Warrant Liabilities: Valued using Black-Scholes and Lattice models, sensitive to stock price and volatility[297] - Inventory Valuation: Lower of cost or net realizable value, subject to assumptions about future demand[298] - Deferred Tax Asset: Valuation allowance based on likelihood of future taxable income[299][300] Quantitative and Qualitative Disclosures About Market Risk Ekso Bionics faces foreign currency risk, with 44% of 2022 sales in foreign currencies, and immaterial interest rate risk on its variable-rate term loan - Foreign Currency Risk: - Approximately 44% of total revenue for the year ended December 31, 2022, was denominated in foreign currencies (mainly U.S. dollars, Euros, and Singapore dollars)[304] - A hypothetical 10% increase in the United States dollar exchange rate would have resulted in a $0.6 million decrease to revenues for 2022[305] - The company has not hedged its exposures to foreign currencies or entered into any other derivative instruments[305] - Interest Rate Risk: - Primarily relates to the term loan with a variable interest rate (greater of 0.50% above prime rate or 4.50%)[306] - A hypothetical 10% change in the lender's prime rate would have an immaterial impact on annualized interest expense[306] Financial Statements and Supplementary Data This section presents Ekso Bionics' audited consolidated financial statements for 2022 and 2021, with an unqualified opinion, noting revenue recognition as a critical audit matter - The independent registered public accounting firm issued an unqualified opinion on the consolidated financial statements for 2022 and 2021[310] - Revenue recognition, specifically the identification of distinct performance obligations, allocation of the transaction price, and timing of revenue recognition for contracts with multiple elements, was identified as a critical audit matter[315][316] Consolidated Balance Sheets (in thousands) | Asset/Liability | Dec 31, 2022 ($) | Dec 31, 2021 ($) | | :------------------------------------------ | :----------- | :----------- | | Assets: | | | | Cash and restricted cash | $20,525 | $40,406 | | Accounts receivable, net | 4,625 | 4,662 | | Inventories | 5,187 | 2,242 | | Prepaid expenses and other current assets | 700 | 485 | | Total current assets | 31,037 | 47,795 | | Property and equipment, net | 2,680 | 991 | | Right-of-use assets | 1,307 | 216 | | Intangible assets, net | 5,217 | — | | Goodwill | 431 | — | | Other assets | 231 | 164 | | Total assets | $40,903 | $49,166 | | Liabilities: | | | | Accounts payable | $3,151 | $3,107 | | Accrued liabilities | 2,278 | 2,299 | | Deferred revenues, current | 1,121 | 1,220 | | Notes payable, current | 2,310 | — | | Lease liabilities, current | 341 | 229 | | Total current liabilities | 9,201 | 6,855 | | Deferred revenues | 1,032 | 1,475 | | Notes payable, net | 3,767 | 1,993 | | Lease liabilities | 1,087 | — | | Warrant liabilities | 233 | 1,550 | | Other non-current liabilities | 141 | 74 | | Total liabilities | $15,461 | $11,947 | | Stockholders' Equity: | | | | Total stockholders' equity | 25,442 | 37,219 | | Total liabilities and stockholders' equity | $40,903 | $49,166 | Consolidated Statements of Operations and Comprehensive Loss (in thousands) | Metric | 2022 ($) | 2021 ($) | | :------------------------------------------ | :----- | :----- | | Revenue | $12,912 | $11,246 | | Cost of revenue | 6,698 | 4,497 | | Gross profit | 6,214 | 6,749 | | Operating expenses: | | | | Sales and marketing | 7,157 | 7,305 | | Research and development | 3,626 | 2,549 | | General and administrative | 10,987 | 10,723 | | Total operating expenses | 21,770 | 20,577 | | Loss from operations | (15,556) | (13,828) | | Other (expense) income, net: | | | | Interest expense | (156) | (113) | | Gain on revaluation of warrant liabilities | 1,317 | 3,962 | | Gain on forgiveness of note payable | — | 1,099 | | Unrealized loss on foreign exchange | (655) | (867) | | Other expense, net | (30) | (17) | | Total other income, net | 476 | 4,064 | | Net loss | $(15,080) | $(9,764) | | Foreign currency translation adjustments | 580 | 830 | | Comprehensive loss | $(14,500) | $(8,934) | | Basic net loss per share applicable to common shareholders | $(1.16) | $(0.80) | | Diluted net loss per share applicable to common shareholders | $(1.16) | $(0.88) | | Weighted average number of shares outstanding, basic | 12,962 | 12,193 | | Weighted average number of shares outstanding, diluted | 12,962 | 12,269 | Consolidated Statements of Cash Flows (in thousands) | Activity | 2022 ($) | 2021 ($) | | :------------------------------------------ | :----- | :----- | | Net cash used in operating activities | $(14,688) | $(11,156) | | Net cash used in investing activities | $(5,175) | $(59) | | Net cash provided by financing activities | $— | $38,712 | | Effect of exchange rate changes on cash | $(18) | $47 | | Net (decrease) increase in cash | $(19,881) | $27,544 | | Cash and restricted cash at beginning of the year | $40,406 | $12,862 | | Cash and restricted cash at end of the year | $20,525 | $40,406 | Report of Independent Registered Public Accounting Firm WithumSmith+Brown, PC issued an unqualified opinion on Ekso Bionics' 2022 and 2021 consolidated financial statements, identifying revenue recognition as a critical audit matter - WithumSmith+Brown, PC issued an unqualified opinion on the consolidated financial statements for the years ended December 31, 2022 and 2021[310] - Revenue recognition, particularly the identification and determination of distinct performance obligations, allocation of transaction price, and timing of revenue recognition for contracts with multiple performance obligations, was identified as a critical audit matter[315][316] Consolidated Balance Sheets Total assets decreased to $40.9 million in 2022, while total liabilities increased to $15.5 million, and stockholders' equity declined to $25.4 million Consolidated Statements of Operations and Comprehensive Loss Revenue increased to $12.9 million in 2022, but gross profit declined, operating expenses rose, leading to a $15.1 million net loss Consolidated Statements of Stockholders' Equity Total stockholders' equity decreased to $25.4 million in 2022, primarily due to a $15.1 million net loss, despite stock-based compensation and foreign currency adjustments Consolidated Statements of Stockholders' Equity (in thousands) | Metric | Dec 31, 2020 ($) | Dec 31, 2021 ($) | Dec 31, 2022 ($) | | :------------------------------------------ | :----------- | :----------- | :----------- | | Total Stockholders' Equity (beginning) | $4,434 | $37,219 | | Net loss | (9,764) | (15,080) | | Issuance of common stock (equity financing, net) | 35,360 | — | | Issuance of common stock (equity incentive plan) | — | — | | Exercise of warrants | 3,878 | — | | Matching contribution to 401(k) plan | 152 | 177 | | Stock-based compensation | 2,329 | 2,546 | | Foreign currency translation adjustments | 830 | 580 | | Total Stockholders' Equity (ending) | $37,219 | $25,442 | | Common Stock Shares Outstanding (ending) | 12,693 | 13,203 | Consolidated Statements of Cash Flows Operating cash flow used $14.7 million in 2022, investing activities used $5.2 million, and no financing cash was generated, resulting in a $19.9 million cash decrease - Net cash used in operating activities increased by $3.5 million in 2022, primarily due to business development expenses, higher headcount compensation, increased inventory purchases, and relocation costs[287] - Net cash used in investing activities increased by $5.1 million in 2022, mainly due to a $5.0 million payment for the HMC Acquisition and leasehold improvements[288] - No cash was provided by financing activities in 2022, compared to $38.7 million in 2021 from common stock and warrant sales and exercises[289] Notes to Consolidated Financial Statements These notes detail Ekso Bionics' financial position, operations, and cash flows, covering business, liquidity, accounting policies, acquisitions, fair value, revenue, assets, liabilities, equity, taxes, and commitments - 1. Organization: Describes business, HMC Acquisition, and liquidity/going concern (accumulated deficit of $223.9 million, $20.5 million cash on hand, reliance on future financing)[331][332] - 2. Summary of Significant Accounting Policies and Estimates: Covers principles of consolidation, use of estimates (e.g., revenue recognition, warrant valuation, inventory, deferred tax assets), foreign currency, credit risk, and recent accounting pronouncements[334][335] - 3. Net Loss Per Share of Common Stock: Reports basic and diluted net loss per share, and anti-dilutive common stock equivalents[336][337] - 4. Human Motion and Control Acquisition: Details the $9.055 million acquisition (cash and promissory note), preliminary fair values of acquired assets (intangibles, goodwill), and pro forma impact[340] - 5. Fair Value Measurement: Explains fair value hierarchy (Level 3 for warrant liabilities) and changes in warrant liability fair value[344][345] - 6. Revenue: Disaggregates revenue by source (device, service, subscriptions) and segment (EksoHealth, EksoWorks), details deferred revenue and backlog[349][350] - 7. Property and Equipment, net: Provides breakdown of property and equipment, depreciation expense, and impairment assessment[353] - 8. Accrued Liabilities: Details components of accrued liabilities, including warranty obligations and activity[356][357] - 9. Goodwill and Intangible Assets: Summarizes goodwill from HMC Acquisition and intangible assets (developed technology, trade name, IP, customer relationships), their amortization, and impairment assessments[358][359][360] - 10. Notes payable, net: Describes the PWB Term Loan (due Aug 2023), PPP loan forgiveness, and Parker Hannifin Promissory Note (payments start Dec 2023)[361][363] - 11. Lease Obligations: Details new operating leases for San Rafael headquarters and Hamburg office, future lease payments, and weighted-average lease terms/discount rates[364][365] - 12. Employee Benefit Plan: Explains the 401(k) plan and company matching contributions[366] - 13. Capitalization and Equity Structure: Summarizes authorized/outstanding common and preferred stock, details equity offerings (Feb 2021, ATM), and various outstanding warrants (2021, June 2020, Dec 2019, May 2019) classified as liabilities[368][370] - 14. Stock-based Compensation: Provides details on the 2014 Equity Incentive Plan, stock option and RSU/PSU activity, unrecognized compensation expense, and the Employee Stock Purchase Plan[371][372] - 15. Income Taxes: Discusses domestic and foreign pre-tax loss, deferred tax assets and liabilities, valuation allowance, NOL carryforwards, and impact of TCJA on R&D costs[373][374] - 16. Commitments and Contingencies: Outlines material contracts (license agreements), purchase obligations, operating lease commitments, and legal matters[375][376] - 17. Segment Disclosures: Presents revenue and gross profit by segment (EksoHealth, EksoWorks) and geographic region (Americas, EMEA, APAC)[378][379] - 18. Related Party Transactions: Details a settlement agreement with an entity affiliated with a board member[380] Changes in and Disagreements With Accountants on Accounting and Financial Disclosure The company reported no changes in or disagreements with accountants regarding accounting and financial disclosure - No changes in or disagreements with accountants on accounting and financial disclosure were reported[521] Controls and Procedures Management concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2022, without an attestation report - Disclosure controls and procedures were evaluated and deemed effective as of December 31, 2022[522] - Management assessed and concluded that internal control over financial reporting was effective as of December 31, 2022, based on the COSO framework[525] - No changes in internal control over financial reporting materially affected or are reasonably likely to materially affect internal control over financial reporting during the most recent fiscal quarter[527] Other Information This item contains no other information - No other information was reported[528] PART III Directors, Executive Officers and Corporate Governance Information on directors, executive officers, and corporate governance is incorporated by reference from the 2023 Proxy Statement - Information required by this Item is incorporated by reference from the company's Proxy Statement for the 2023 Annual Meeting of Stockholders[530] Executive Compensation Executive compensation information is incorporated by reference from the company's 2023 Proxy Statement - Information required by this Item is incorporated by reference from the company's Proxy Statement for the 2023 Annual Meeting of Stockholders[531] Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters Security ownership details for beneficial owners and management are incorporated by reference from the 2023 Proxy Statement - Information required by this Item is incorporated by reference from the company's Proxy Statement for the 2023 Annual Meeting of Stockholders[532] Certain Relationships and Related Transactions and Director Independence Information on related party transactions and director independence is incorporated by reference from the 2023 Proxy Statement - Information required by this Item is incorporated by reference from the company's Proxy Statement for the 2023 Annual Meeting of Stockholders[533] Principal Accountant Fees and Services Principal accountant fees and services information is incorporated by reference from the company's 2023 Proxy Statement - Information required by this Item is incorporated by reference from the company's Proxy Statement for the 2023 Annual Meeting of Stockholders[534] PART IV Exhibits, Financial Statements and Financial Statement Schedules This section lists financial statements from Item 8 and provides an index of exhibits, including the HMC Acquisition agreement and organizational documents - Financial statement documents included as part of Item 8: Report of Independent Registered Public Accounting Firm, Consolidated Balance Sheets, Consolidated Statements of Operations and Comprehensive Loss, Consolidated Statements of Stockholders' Equity, Consolidated Statements of Cash Flows, and Notes to the Consolidated Financial Statements[536] - All schedules are omitted because they are not applicable or the required information is shown in the financial statements or notes thereto[537] - The Exhibit Index details various documents filed, including the Asset Purchase Agreement for the HMC Acquisition, Articles of Incorporation, By-Laws, forms of Common Stock Purchase Warrants, Subordinated Promissory Note, and License Agreements with UC Berkeley and Vanderbilt University[540][541][542] 10-K Summary The company has elected not to include summary information for this item - The company has elected not to include summary information[544] Signatures The Annual Report on Form 10-K was signed on March 28, 2023, by key executives and Board members - The Annual Report was signed on March 28, 2023, by the President and Chief Executive Officer, Chief Financial Officer, and members of the Board of Directors[548][551]