Eledon Pharmaceuticals, Inc. 10-Q

Item 1. Financial Statements ELEDON PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except share data) (Unaudited) September 30, 2021 December 31, 2020 ASSETS Current assets: Cash and cash equivalents $ 94,041 $ 114,195 Prepaid expenses and other current assets 1,517 1,435 Total current assets 95,558 115,630 Operating lease asset, net 222 138 Goodwill 48,648 48,648 In-process research and development 32,386 32,386 Other assets 356 383 Total assets $ 177,170 $ 197,185 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $ 1,598 $ 1,366 Current operating lease liability 177 144 Accrued expenses and other liabilities 2,271 973 Total current liabilities 4,046 2,483 Deferred tax liabilities 2,331 4,106 Non-current operating lease liability 45 — Total liabilities 6,422 6,589 Commitments and contingencies (Note 5) Stockholders’ equity: Series X 1 non-voting convertible preferred stock, $ 0.001 par value, 515,000 shares authorized; 108,070 shares issued and outstanding at September 30, 2021 and December 31, 2020 — — Series X preferred stock, $ 0.001 par value, 10,000 shares authorized; 6,204 and no shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively — — Common stock, $ 0.001 par value, 200,000,000 shares authorized at September 30, 2021 and December 31, 2020; 14,306,788 and 15,160,397 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively 14 15 Additional paid-in capital 276,827 270,974 Accumulated deficit ( 106,093 ) ( 80,393 ) Total stockholders’ equity 170,748 190,596 Total liabilities and stockholders’ equity $ 177,170 $ 197,185 See accompanying notes to unaudited condensed consolidated financial statements. 7 ELEDON PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands, except share and per share data) (Unaudited) For the Three Months Ended September 30, For the Nine Months Ended September 30, 2021 2020 2021 2020 Operating expenses Research and development $ 7,658 $ 615 $ 17,553 $ 3,095 General and administrative 2,848 3,731 9,929 6,730 Restructuring expense — 1,802 — 2,292 Total operating expenses 10,506 6,148 27,482 12,117 Loss from operations ( 10,506 ) ( 6,148 ) ( 27,482 ) ( 12,117 ) Other income, net 3 4 7 39 Warrant inducement expense — — — ( 4,829 ) Loss before income tax benefit ( 10,503 ) ( 6,144 ) ( 27,475 ) ( 16,907 ) Income tax benefit 686 — 1,775 — Net loss and comprehensive loss $ ( 9,817 ) $ ( 6,144 ) $ ( 25,700 ) $ ( 16,907 ) Net loss per share, basic and diluted $ ( 0.66 ) $ ( 5.51 ) $ ( 1.73 ) $ ( 16.81 ) Weighted-average common shares outstanding, basic and diluted 14,815,852 1,114,133 14,820,822 1,006,008 See accompanying notes to unaudited condensed consolidated financial statements. 8 ELEDON PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (In thousands, except share data) (Unaudited) Series X 1 Non-Voting Convertible Preferred Stock Series X 1 Non-Voting Convertible Preferred Stock Series X Preferred Stock Common Stock Additional Paid-In Accumulated Shares Amount Shares Amount Shares Amount Shares Amount Capital Deficit Total Balance as of December 31, 2020 — $ — 108,070 $ — — $ — 15,160,397 $ 15 $ 270,974 $ ( 80,393 ) $ 190,596 Cancellation of common stock in connection with exchange for preferred stock — — — — 6,204 — ( 344,666 ) — — — — Cancellation of common stock in connection with exchange for warrants — — — — — — ( 509,117 ) ( 1 ) 1 — — Stock-based compensation — — — — — — — — 5,851 — 5,851 Stock options exercised — — — — — — 174 — 1 — 1 Net loss and other comprehensive loss — — — — — — — — — ( 25,700 ) ( 25,700 ) Balance as of September 30, 2021 — $ — 108,070 $ — 6,204 $ — 14,306,788 $ 14 $ 276,827 $ ( 106,093 ) $ 170,748 Balance as of June 30, 2021 — $ — 108,070 $ — 6,204 $ — 14,306,614 $ 14 $ 274,783 $ ( 96,276 ) $ 178,521 Stock-based compensation — — — — — — — — 2,043 — 2,043 Stock options exercised — — — — — — 174 — 1 — 1 Net loss and other comprehensive loss — — — — — — — — — ( 9,817 ) ( 9,817 ) Balance as of September 30, 2021 — $ — 108,070 $ — 6,204 $ — 14,306,788 $ 14 $ 276,827 $ ( 106,093 ) $ 170,748 Balance as of December 31, 2019 — $ — — $ — — $ — 720,408 $ 1 $ 67,046 $ ( 57,582 ) $ 9,465 Issuance of common stock in connection with exercise of warrants, net of issuance costs — — — — — — 404,068 — 5,191 — 5,191 Issuance of common stock in connection with conversion of preferred stock — — — — ( 3,285 ) — 182,500 — — — — Issuance of common stock in connection with vesting of restricted stock units — — — — — — 3,056 — — — — Issuance of common stock in connection with acquisition — — — — — — 175,488 — 1,194 — 1,194 Cancellation of common stock in connection with exchange for preferred stock — — — — 3,796 — ( 210,889 ) — — — — Issuance of preferred stock in connection with acquisition 140,026 69,723 — — — — — — — — — Issuance of preferred stock in connection with PIPE transaction, net of issuance costs 199,112 95,226 — — — — — — — — — Fair value of options assumed in acquisition — — — — — — — — 3,278 — 3,278 Fair value of warrants assumed in acquisition — — — — — — — — 12,944 — 12,944 Warrant inducement expense — — — — — — — — 4,829 — 4,829 Stock-based compensation — — — — — — — — 1,512 — 1,512 Net loss and other comprehensive loss — — — — — — — — — ( 16,907 ) ( 16,907 ) Balance as of September 30, 2020 339,138 $ 164,949 — $ — 511 $ — 1,274,631 $ 1 $ 95,994 $ ( 74,489 ) $ 21,506 Balance as of June 30, 2020 — $ — — $ — 511 $ — 1,076,642 $ 1 $ 77,700 $ ( 68,345 ) $ 9,356 Issuance of common stock in connection with cashless exercise of warrants — — — — — — 20,834 — — — — Issuance of common stock in connection with vesting of restricted stock units — — — — — — 1,667 — — — — Issuance of common stock in connection with acquisition — — — — — — 175,488 — 1,194 — 1,194 Issuance of preferred stock in connection with acquisition 140,026 69,723 — — — — — — — — — Issuance of preferred stock in connection with PIPE transaction, net of issuance costs 199,112 95,226 — — — — — — — — — Fair value of options assumed in acquisition — — — — — — — — 3,278 — 3,278 Fair value of warrants assumed in acquisition — — — — — — 12,944 — 12,944 Stock-based compensation — — — — — — — — 878 — 878 Net loss and other comprehensive loss — — — — — — — — — ( 6,144 ) ( 6,144 ) Balance as of September 30, 2020 339,138 $ 164,949 — $ — 511 $ — 1,274,631 $ 1 $ 95,994 $ ( 74,489 ) $ 21,506 See accompanying notes to unaudited condensed consolidated financial statements. 9 ELEDON PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (In thousands) (Unaudited) For the Nine Months Ended September 30, 2021 2020 Operating activities Net loss $ ( 25,700 ) $ ( 16,907 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization — 5 Amortization of operating lease asset 134 133 Warrant inducement expense — 4,829 Stock-based compensation 5,851 1,512 Deferred tax liabilities ( 1,775 ) — Changes in operating assets and liabilities: Prepaid expenses and other assets ( 55 ) 771 Accounts payable and accrued expenses 1,980 4,011 Operating lease liability ( 140 ) ( 133 ) Net cash used in operating activities ( 19,705 ) ( 5,779 ) Investing activities Cash and cash equivalents received from acquisition — 11,035 Net cash provided by investing activities — 11,035 Financing activities Proceeds from issuances of non-voting preferred stock, net — 95,226 Proceeds from exercise of warrants, net — 5,191 Proceeds from exercise of stock options 1 — Offering costs in connection with PIPE transaction ( 450 ) — Net cash (used in) provided by financing activities ( 449 ) 100,417 Net change in cash and cash equivalents ( 20,154 ) 105,673 Cash and cash equivalents at beginning of period 114,195 8,791 Cash and cash equivalents at end of period $ 94,041 $ 114,464 Supplemental disclosure of non-cash investing and financing activities Common stock exchanged for warrants $ 1 $ — Increase in operating lease asset and liability due to lease modification $ 219 $ — Issuance of common stock in acquisition $ — $ 1,194 Issuance of non-voting convertible preferred stock in acquisition $ — $ 69,723 Fair value of options assumed in acquisition $ — $ 3,278 Fair value of warrants assumed in acquisition $ — $ 12,944 See accompanying notes to unaudited condensed consolidated financial statements. 10 ELEDON PHARMACEUTICALS, INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) Note 1. Description of Business Eledon Pharmaceuticals, Inc. (formerly Novus Therapeutics, Inc.) is a clinical stage biopharmaceutical company focused on discovering or acquiring, and then developing life-changing, targeted medicines for persons requiring an organ or cell-based transplant, living with autoimmune disease, or living with amyotrophic lateral sclerosis (“ALS”). We believe that this approach has the potential to allow us to: develop more precise therapies with a resulting potential for both increased efficacy and safety; identify patients and indications more likely to respond to our treatment approaches; and pursue multiple indications for product candidates. The Company’s lead compound in development is AT-1501, an IgG1, anti-CD40L antibody with high affinity for CD40 ligand (CD40L, also called CD154), a well-validated biological target with broad therapeutic potential. AT-1501 is engineered to potentially both improve safety and provide pharmacokinetic, pharmacodynamic, and dosing advantages compared to other anti-CD40 approaches. The central role of CD40/CD40L signaling in generating pro-inflammatory responses makes it an attractive candidate for therapeutic intervention in autoimmune disease, induction and maintenance of transplant tolerance, and neuroinflammation. Blocking the activation of the CD40L pathway prevents acute and long-term allograft transplant rejection in multiple animal species and ameliorates disease progression and pathology in preclinical models of autoimmunity and ALS. Unless otherwise indicated, references to the terms “Eledon,” “our,” “us,” “we”, or the “Company” refer to Eledon Pharmaceuticals, Inc. and its wholly-owned subsidiaries, on a consolidated basis. On September 14, 2020 , we acquired Anelixis Therapeutics, Inc. (“Anelixis”), a privately held clinical stage biotechnology company developing a next generation anti-CD40L antibody as a potential treatment for organ and cellular transplantation, autoimmune diseases, and neurodegenerative diseases (see Note 7). Following the acquisition of Anelixis, we changed our name to Eledon Pharmaceuticals, Inc. The Company has continued to maintain its corporate headquarters in Irvine, California and has research and development facilities in the Boston, Massachusetts area. Note 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) and Article 8 of Regulation S-X requirements as set forth by the Securities and Exchange Commission (“SEC”) for interim financial information and reflect all adjustments and disclosures, which are, in the opinion of management, of a normal and recurring nature, and considered necessary for a fair presentation of the financial information contained herein. Pursuant to these rules and regulations, the unaudited condensed consolidated financial statements do not include all information and notes necessary for a complete presentation of results of operations and comprehensive loss, financial position, and cash flows in conformity with GAAP. The accompanying unaudited condensed consolidated financial statements and notes should be read in conjunction with the audited financial statements and accompanying notes of Eledon for the year ended December 31, 2020 included in the Annual Report on Form 10-K filed by the Company with the SEC on March 31, 2021. The results of operations and comprehensive loss for the three and nine months ended September 30, 2021 are not necessarily indicative of results expected for the full fiscal year or any other future period. Principles of Consolidation Eledon, a Delaware corporation, owns 100 % of the issued and outstanding common stock or other ownership interest in Anelixis Therapeutics, LLC, a Delaware corporation, and Otic Pharma, Ltd., a private limited company organized under the laws of the State of Israel (“Otic”). Otic owns 100 % of the issued and outstanding common stock or other ownership interest in its U.S. subsidiary, Otic Pharma, Inc. The functional currency of the Company’s foreign subsidiary is the U.S. Dollar; however, certain expenses, assets and liabilities are transacted at the local currency. These transactions are translated from the local currency into U.S. Dollars at exchange rates during or at the end of the reporting period. The activities of the Company’s foreign subsidiary are not significant to the condensed consolidated financial statements. All significant intercompany accounts and transactions among the entities have been eliminated from the condensed consolidated financial statements. 11 Liquidity and Financial Condition The Company has experienced recurring net losses and negative cash flows from operating activities since its inception. The Company recorded a net loss of $ 9.8 million and $ 25.7 million for the three and nine months ended September 30, 2021, respectively. As of September 30, 2021, the Company had cash and cash equivalents of $ 94.0 million, working capital of $ 91.5 million and an accumulated deficit of $ 106.1 million. Due to continuing research and development activities, the Company expects to continue to incur net losses into the foreseeable future. In order to continue these activities, the Company will need to raise additional funds through public or private debt and equity financings or strategic collaboration and licensing arrangements. The Company’s ability to raise additional capital in the equity and debt markets is dependent on a number of factors, including, but not limited to, the market demand for the Company’s common stock, which itself is subject to a number of development and business risks and uncertainties, as well as the uncertainty that the Company would be able to raise such additional capital at a price or on terms that are favorable to the Company. If the Company issues equity or convertible debt securities to raise additional funding, its existing stockholders may experience dilution, it may incur significant financing costs, and the new equity or convertible debt securities may have rights, preferences and privileges senior to those of its existing stockholders. If the Company issues debt securities to raise additional funding, it would incur additional debt service obligations, it could become subject to additional restrictions limiting its ability to operate its business, and it may be required to further encumber its assets. At the time of issuance of the condensed consolidated financial statements for the three and nine months ended September 30, 2021, the Company’s management performed an analysis and concluded that the Company had sufficient cash resources to meet its anticipated cash needs through at least the next 12 months from the date of issuance of the accompanying condensed consolidated financial statements. Use of Estimates The preparation of the Company’s condensed consolidated financial statements in conformity with GAAP requires management to make informed estimates and assumptions that affect the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in the Company’s unaudited condensed consolidated financial statements and accompanying notes. The most significant estimates in the Company’s consolidated financial statements relate to stock-based transactions, accruals for liabilities, fair value of assets acquired and liabilities assumed in a business combination, impairment of long lived assets, including goodwill, and other matters that affect the condensed consolidated financial statements and related disclosures. Actual results could differ materially from those estimates under different assumptions or conditions and the differences may be material to the condensed consolidated financial statements. Cash and Cash Equivalents Cash represents cash deposits held at financial institutions. The Company considers all liquid investments purchased with an original maturity of three months or less and that can be liquidated without prior notice or penalty to be cash equivalents. Cash equivalents are held for the purpose of meeting short-term liquidity requirements, rather than for investment purposes. The Company had $ 9.2 million of cash equivalents at September 30, 2021 and December 31, 2020. Concentration of Credit Risk and Other Risks and Uncertainties As of September 30, 2021 and December 31, 2020, all of the Company’s long-lived assets were located in the United States. Financial instruments that are subject to concentration of credit risk consist primarily of cash equivalents. The Company’s policy is to invest cash in institutional money market funds to limit the amount of credit exposure. At times, the Company maintains cash equivalents in short‑term money market funds and it has not experienced any losses on its cash equivalents. The Company’s products will require approval from the U.S. Food and Drug Administration (“FDA”) and foreign regulatory agencies before commercial sales can commence. There can be no assurance that the Company’s products will receive any of these required approvals. The denial or delay of such approvals may impact the Company’s business in the future. In addition, after approval by the FDA, there is still an ongoing risk of adverse events that did not appear during the product approval process. 12 The Company is subject to risks common to companies in the pharmaceutical industry, including, but not limited to, new technological innovations, clinical development risk, establishment of appropriate commercial partnerships, protection of proprietary technology, compliance with government and environmental regulations, uncertainty of market acceptance of products, product liability, the volatility of its stock price and the need to obtain additional financing. Our facilities and equipment, including those of our suppliers and vendors, may be affected by natural or man-made disasters. Our administrative office is based in Irvine, California and we manage all our research and development activities through third parties that are located throughout the world. We have taken precautions to safeguard our facilities, equipment and systems, including insurance, health and safety protocols, and off-site storage of computer data. However, our facilities and systems, as well as those of our third-party suppliers and vendors, may be vulnerable to earthquakes, fire, storm, health emergencies, including the ongoing COVID-19 pandemic, power loss, telecommunications failures, physical and software break-ins, software viruses and similar events which could cause substantial delays in our operations, damage or destroy our equipment or inventory, and cause us to incur additional expenses and delay research and development activities. In addition, the insurance coverage we maintain may not be adequate to cover our losses in any circumstance and may not continue to be available to use on acceptable terms, or at all. Reportable Segments Operating segments under GAAP are defined as components of an enterprise about which separate financial information is available that is evaluated regularly by the Chief Operating Decision Maker (“CODM”), or decision-making group, in deciding how to allocate resources and in assessing performance. The CODM is the Company’s Chief Executive Officer and the Company has determined that it operates in one business segment, which is the development of products for therapeutic medicines selectively targeting critical pathways associated with the underlying molecular pathogenesis for patients with severe inflammation and autoimmune diseases. Research and Development Expenses Research and development expenses include personnel and facility-related expenses, outside contracted services including clinical trial costs, manufacturing and process development costs, research costs and other consulting services and non-cash stock-based compensation. Research and development costs are expensed as incurred. Amounts due under contracts with third parties may be either fixed fee or fee for service, and may include upfront payments, monthly payments and payments upon the completion of milestones or receipt of deliverables. Non-refundable advance payments under agreements are capitalized and expensed as the related goods are delivered or services are performed. The Company contracts with third parties to perform various clinical trial activities in the on-going development of potential products. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows to its vendors. Payments under the contracts depend on factors such as the achievement of certain events, successful enrollment of patients, and completion of portions of the clinical trial or similar conditions. The Company’s accrual for clinical trials is based on estimates of the services received and efforts expended pursuant to contracts with clinical trial centers and clinical research organizations. These contracts may be terminated by the Company upon written notice and the Company is generally only liable for actual effort expended by the organizations to the date of termination, although in certain instances the Company may be further responsible for termination fees and penalties, as well as reasonable shutdown costs. The Company estimates its research and development expenses and the related accrual as of each balance sheet date based on the facts and circumstances known to the Company at that time. There have been no material adjustments to the Company’s prior‑period accrued estimates for clinical trial activities through September 30, 2021. Net Loss Per Share Basic net loss per common share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares and potentially dilutive securities outstanding for the period determined using the treasury-stock and if-converted methods. For purposes of the diluted net loss per share calculation, preferred stock, convertible notes and accrued interest, stock options, warrants and restricted stock units are considered to be potentially dilutive securities and are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive. Therefore, basic and diluted net loss per share was the same for the periods presented due to the Company’s net loss position. Basic weighted average shares outstanding for the three and nine months ended September 30, 2021, include 509,117 shares underlying warrants to purchase common shares. As the shares underlying these warrants can be issued for 13 little consideration (an exercise price per share equal to $ 0.001 per share), these shares are deemed to be issued for purposes of basic earnings per share. For the Three Months Ended September 30, For the Nine Months Ended September 30, 2021 2020 2021 2020 (In thousands, except share and per share data) Net loss used in the calculation of basic and diluted loss per share $ ( 9,817 ) $ ( 6,144 ) $ ( 25,700 ) $ ( 16,907 ) Net loss per share, basic and diluted $ ( 0.66 ) $ ( 5.51 ) $ ( 1.73 ) $ ( 16.81 ) Weighted-average number of common shares, basic and diluted 14,815,852 1,114,133 14,820,822 1,006,008 The computation of diluted earnings per share excludes stock options, warrants, and restricted stock units that are anti-dilutive. As of September 30, 2021 and 2020, common share equivalents of 674,295 shares and 1,828,531 shares were anti-dilutive, respectively. Stock-based Compensation The Company recognizes compensation expense for all stock-based awards based on the grant-date estimated fair value. The fair value of stock options is determined using the Black-Scholes option pricing model, using assumptions that are subjective and require significant judgment and estimation by management. The risk-free rate assumption was based on observed yields from governmental zero-coupon bonds with an equivalent term. The expected volatility assumption was based on historical volatilities of a group of comparable industry companies whose share prices are publicly available. The peer group was developed based on companies in the pharmaceutical industry. The expected term of stock options represents the weighted-average period that the stock options are expected to be outstanding. Because the Company does not have historical exercise behavior, it determined the expected life assumption using the simplified method for options granted to employees, which is an average of the options ordinary vesting period and the contractual term. For stock options granted to the board of directors, the Company determined the expected life assumption using the simplified method as the starting point with an average period of twelve (12) months added to take into account for the extended range of time of 12 to 18 months vested stock options granted to board of directors may be exercised upon termination. The expected dividend assumption was based on the Company’s history and expectation of dividend payouts. The Company has not paid and does not expect to pay dividends at any time in the foreseeable future. The Company recognizes forfeitures on an actual basis and as such did not estimate forfeitures to calculate stock-based compensation. Restricted Stock Units (“RSU”) and Performance-Based Restricted Stock Units (“PRSU”) are measured and recognized based on the quoted market price of our common stock on the date of grant. In March 2020, the Board of Directors approved an increase of 28,816 shares issuable under the 2014 Stock Incentive Plan (the “2014 Plan”) and 7,204 shares issuable under the 2014 Employee Stock Purchase Plan (the “ESPP”). On December 18, 2020, the Company held the Special Meeting, whereby the Company’s stockholders approved the 2020 Long Term Incentive Plan (the “2020 Plan”). The aggregate number of shares of stock available for issuance under the 2020 Plan will initially be 4,860,000 shares of Common Stock, which represents approximately 15 % of the total issued and outstanding shares of the Company’s common stock as of the record date of the Special Meeting (calculated on an as-converted basis and without regard to the potential application of beneficial ownership conversion limitations on the Preferred Stock) and may be increased by the number of shares under the 2014 Plan that expire, terminate or are otherwise surrendered, cancelled, forfeited or repurchased by the Company . Based on projected utilization rates, the Board of Directors currently intends that the initial shares under the 2020 Plan will be sufficient to fund the Company’s equity compensation needs for approximately 3 years. The 2014 Plan was closed to new grants following the approval of the 2020 plan, and therefore, there were no longer any shares reserved for issuance under the 2014 Plan as of December 31, 2020. The number of shares reserved for issuance under the 2020 Plan and ESPP was 4,082,708 and 24,077 shares, respectively, as of September 30, 2021. 14 Reclassifications Certain reclassifications of prior period amounts have been made to conform to the current period presentation. Recently Adopted Accounting Pronouncements No new accounting pronouncement issued or effective during the fiscal period had or is expected to have a material impact on the Company’s condensed consolidated financial statements or disclosures. Note 3. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following (in thousands): September 30, December 31, 2021 2020 Prepaid insurance $ 359 $ 1,157 Prepaid clinical 1,097 89 Prepaid other 50 41 Insurance receivable — 110 Other current assets 11 38 Total prepaid expenses and other current assets $ 1,517 $ 1,435 Note 4. Accrued Expenses and Other Liabilities Accrued expenses and other liabilities consisted of the following (in thousands): September 30, December 31, 2021 2020 Accrued compensation and related expenses $ 783 $ 31 Accrued severance 337 12 Accrued clinical 912 258 Accrued professional services 52 9 Accrued vacation 148 67 Accrued costs associated with PIPE financing — 450 Accrued other 39 146 Total accrued expenses and other liabilities $ 2,271 $ 973 Note 5. Commitments and Contingencies Operating Leases The Company leases office space under various operating leases. Total rental expense for all operating leases in the accompanying condensed consolidated statements of operations and comprehensive loss was $ 63,000 and $ 50,000 for the three months ended September 30, 2021 and 2020, respectively, and $ 189,000 and $ 143,000 for the nine months ended September 30, 2021 and 2020, respectively. The Company has an operating lease for 5,197 square feet of office space in Irvine, California, which was set to expire on September 30, 2021 . On May 3, 2021, the Company extended the term of the lease through December 31, 2022 , by amending the office lease effective October 1, 2021 . Additionally, the Company had operating leases for four serviced office spaces in Burlington, Massachusetts that expired on June 30, 2021 , which have been converted to monthly leases . The Burlington, Massachusetts office leases are considered short-term leases and are not recorded on the condensed consolidated balance sheet. The Company determines if a contract contains a lease at inception. Our office leases have a remaining term ranging from one month to eighteen months and do not include options to extend the leases for additional periods. 15 Operating lease assets and liabilities are recognized at the lease commencement date. Operating lease liabilities represent the present value of lease payments not yet paid. Operating lease assets represent our right to use an underlying asset and are based upon the operating lease liabilities as adjusted for prepayments or accrued lease payments, initial direct costs, lease incentives, and impairment of operating lease assets . To determine the present value of lease payments not yet paid, we estimate incremental secured borrowing rates corresponding to the maturities of the leases. As we have no outstanding debt nor committed credit facilities, secured or otherwise, we estimate this rate based on prevailing financial market conditions, comparable company and credit analysis, and management ’s judgment. Our Irvine lease contains rent escalations over the lease term. We recognize expense for these leases on a straight-line basis over the lease term. Additionally , tenant incentives used to fund leasehold improvements are recognized when earned and reduce our right-of-use asset related to the lease. These are amortized through the right-of-use asset as reductions of expense over the lease term. Our lease agreement does not contain any material residual value guarantees or material restrictive covenants. While we do not currently have any lease agreement with lease and non-lease components, we elected to account for lease and non-lease components as separate components. We have elected the short-term lease recognition exemption for all applicable classes of underlying assets. Short-term disclosures include only those leases with a term greater than one month and 12 months or less, and expense is recognized on a straight-line basis over the lease term. Leases with an initial term of 12 months or less, that do not include an option to purchase the underlying asset that we are reasonably certain to exercise, are not recorded on the condensed consolidated balance sheet. The components of lease expense were as follows: Nine Months Ended September 30, 2021 Operating lease cost (a) $ 145 (a) Includes variable operating lease expenses, which are immaterial Other information related to leases was as follows (in thousands, except lease term and discount rate): Nine Months Ended September 30, 2021 Supplemental Cash Flows Information Cash paid for amounts included in the measurement of lease liability: Operating cash flows from operating lease $ 146 Remaining lease term Operating lease 1.25 Discount rate Operating lease 3.18 % Future payments under noncancelable operating leases having initial or remaining terms of one year or more are as follows for the remaining fiscal year and thereafter (in thousands): Years ending 2021 (remainder of) $ 45 2022 181 Total minimum lease payments 226 Less imputed interest ( 4 ) Present value of lease liabilities 222 Less current portion of operating lease liability ( 177 ) Non-current operating lease liability $ 45 16 Grants and Licenses ALS Therapy Development Foundation, Inc. License Agreement In May 2015, Anelixis executed a License Agreement (the “Agreement”), which is an exclusive patent rights agreement with ALS Therapy Development Foundation, Inc. (“ ALSTDI”) for certain patents and “know-how” of ALSTDI. This agreement continues until the licensee terminates the agreement with ninety days written notice. The Agreement requires license fees payable to ALSTDI, subject to the achievement of certain milestones and other conditions. The first and second milestones of the Agreement are the dosing of the first subjects in a first toxicity study in non-human primates and the dosing of the first patient in a Phase I Clinical Trial, respectively. Both of these milestones were achieved as of December 31, 2018 and 2017. The fee due for the achievement of these milestones was $ 1.0 million each. During 2018 and 2017, Anelixis issued $ 1.0 million worth of its common stock in lieu of making a cash payment. There were no milestones achieved during the nine months ended September 30, 2021 and the year ended December 31, 2020. The Agreement was amended and restated in February 2020, and a first amendment to the restated license agreement was executed in September 2020. As amended in September 2020, the remaining milestone payments for a first licensed product total $ 6.0 million. In the event that the Company develops a second licensed product, the Company is obligated to pay up to $ 2.5 million in additional milestone payments. In addition to the milestone payments, the Company is required to pay ALSTDI an amended annual license maintenance fee of $ 0.1 million beginning on the earlier of January 1, 2022, the Company’s first sublicense, or change in control, as defined in the Agreement. Furthermore, the Company shall pay ALSTDI fees based on reaching certain levels of annual net sales of any product produced with the patent rights. A royalty in the low single digits will be due on aggregate net sales. Upon the first calendar year of reaching $ 500.0 million in aggregate net sales, the Company shall pay ALS TDI a one-time milestone payment of $ 15.0 million. Upon the first calendar year of reaching $ 1.0 billion in aggregate net sales, the Company is obligated to pay ALSTDI a one-time milestone payment of $ 30.0 million. Israeli Innovation Authority Grant From 2012 through 2015, the Company received grants in the amount of approximately $ 0.5 million from the Israeli Innovation Authority (previously the Office of Chief Scientist) of the Israeli Ministry of Economy and Industry designated for investments in research and development. The grants are linked to the U.S. Dollar and bear annual interest of LIBOR. The grants are to be repaid out of royalties from sales of the products developed by the Company from its investments in research and development. Because the Company has not yet earned revenues related to these investments and cannot estimate potential royalties, no liabilities related to these grants have been recorded as of each period presented. Repayment of the grant is contingent upon the successful completion of the Company’s research and development programs and generating sales. The Company has no obligation to repay these grants, if the research and development program fails, is unsuccessful or aborted or if no sales are generated. The Company has not yet generated sales as of September 30, 2021; therefore, no liability was recorded for the repayment in the accompanying condensed consolidated financial statements. Legal Matters The Company may be involved in various lawsuits and claims arising in the ordinary course of business, including actions with respect to intellectual property, employment, and contractual matters. In connection with these matters, the Company assesses, on a regular basis, the probability and range of possible loss based on the developments in these matters. A liability is recorded in the financial statements if it is believed to be probable that a loss has been incurred and the amount of the loss can be reasonably estimated. Because litigation is inherently unpredictable and unfavorable results could occur, assessing contingencies is highly subjective and requires judgments about future events. The Company regularly reviews outstanding legal matters to determine the adequacy of the liabilities accrued and related disclosures. The amount of ultimate loss may differ from these estimates. Each matter presents its own unique circumstances, and prior litigation does not necessarily provide a reliable basis on which to predict the outcome, or range of outcomes, in any individual proceeding. Because of the uncertainties related to the occurrence, amount, and range of loss on any pending litigation or claim, the Company does not consider a liability probable and is currently unable to predict their ultimate outcome, and, with respect to any pending litigation or claim where no liability has been accrued, to make a meaningful estimate of the reasonably possible 17 loss or range of loss that could result from an unfavorable outcome. In the event that opposing litigants in outstanding litigation proceedings or claims ultimately succeed at trial and any subsequent appeals on their claims, any potential loss or charges in excess of any established accruals, individually or in the aggregate, could have a material adverse effect on the Company’s business, financial condition, results of operations, and/or cash flows in the period in which the unfavorable outcome occurs or becomes probable, and potentially in future periods. Legal Proceedings We are not currently a party to any material legal proceedings. We may, however, in the ordinary course of business face various claims brought by third parties or government regulators and we may, from time to time, make claims or take legal actions to assert our rights, including claims relating to our directors, officers, stockholders, intellectual property rights, employment matters and the safety or efficacy of our products. Indemnification In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnification. The Company’s exposure under these agreements is unknown because it involves future claims that may be made against the Company but have not yet been made. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations. However, the Company may record charges in the future because of these indemnification obligations. No amounts associated with such indemnifications have been recorded to date. Contingencies From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of business activities. The Company accrues a liability for such matters when it is probable that future expenditures will be made, and such expenditures can be reasonably estimated. There have been no contingent liabilities requiring accrual at September 30, 2021. Note 6. Stockholders’ Equity Equity Distribution Agreement On March 31, 2021, the Company filed a prospectus and prospectus supplement (the “2021 Prospectus”) under which the Company may offer and sell, from time to time, pursuant to an equity distribution agreement with Jeffries LLC, up to $ 75.0 million in shares of its common stock. During the nine months ended September 30, 2021, no shares were sold under the 2021 Prospectus. Common Stock Warrants As of September 30, 2021, a total of 1,145,631 warrants were exercisable into common stock. The shares of common stock underlying the warrants are registered for offer and sale under the Securities Act of 1933, as amended (the “Securities Act”), pursuant to the Company’s effective registration statements on Form S-1. On September 21, 2021, the Company issued warrants exercisable for 298,692 shares of common stock in exchange for warrants exercisable for 5,376.456 shares of Series X 1 Non-Voting Convertible Preferred Stock (“Series X 1 Preferred Stock”) previously issued as part of the Anelixis merger. These Series X 1 Preferred Stock warrants were replaced by Eledon for the outstanding warrants issued by Anelixis that were not settled upon completion of the merger. 18 The following table shows the warrant activity: Rollforward of Warrant Activity Registered direct warrants, placement agent Private placement warrants Private placement warrants, placement agent Warrants exchanged for common stock Warrants exchanged for preferred stock warrants Total Balance as of December 31, 2020 9,581 319,064 9,177 — — 337,822 Issued — — — 509,117 298,692 807,809 Exercised — — — — — — Cancelled/Expired — — — — — — Balance as of September 30, 2021 9,581 319,064 9,177 509,117 298,692 1,145,631 Preferred Stock Warrants As of September 30, 2021, 50,207.419 warrants were exercisable into Series X 1 Preferred Stock. Each share of Series X 1 Preferred Stock is convertible into approximately 55.5556 shares of common stock. The following table shows the warrant activity: Rollforward of Warrant Activity Warrants assumed and replaced in acquisition Total Balance as of December 31, 2020 55,583.875 55,583.875 Assumed and replaced — — Exercised — — Cancelled/Exchanged ( 5,376.456 ) ( 5,376.456 ) Balance as of September 30, 2021 50,207.419 50,207.419 Exchange Agreements On December 31, 2020, the Company entered into an exchange agreement (the “Series X Exchange Agreement”) with Biotechnology Value Fund, L.P., Biotechnology Value Fund II, L.P., Biotechnology Value Trading Fund OS, L.P. , MSI BVF SPV, L.L.C. (collectively, the “BVF Exchanging Stockholders”) and Cormorant Global Healthcare Master Fund, LP (together with the BVF Exchanging Stockholders, the “Series X Exchanging Stockholders”), pursuant to which the Series X Exchanging Stockholders exchanged (the “Series X Exchange”) 344,666 shares of the Company’s common stock for 6,203.98 shares of Series X Convertible Preferred Stock. In addition, on December 31, 2020 the Company entered into an exchange agreement (the “Warrant Exchange Agreement,” and together with the Series X Exchange Agreement, the “Exchange Agreements”) with the BVF Exchanging Stockholders, pursuant to which the BVF Exchanging Stockholders exchanged (the “Warrant Exchange,” and together with the Series X Exchange, the “Exchanges”) 509,117 shares of the Common Stock for one or more pre-funded warrants to purchase an aggregate of 509,117 shares of the Common Stock at a nominal exercise price (the “Warrants”). The Company recorded the shares of Series X Convertible Preferred Stock and Warrants issuable as preferred stock and warrant subscriptions at December 31, 2020 since the physical settlement of the Exchanges was made on January 5, 2021, whereby the transfer agent recorded the exchange of common stock for the issuance of preferred stock and warrants. Following the Exchanges, the Company had 6,203.98 shares of Series X Preferred Stock outstanding, which are convertible into 344,663 shares of Common Stock (after rounding for fractional shares). 19 As of September 30, 2021, a total of 509,117 warrants were available for exercise. The shares of common stock underlying the registered direct placement agent warrants are registered for offer and sale under the Securities Act, pursuant to the Company’s effective registration statements on Form S-1. Stock-Based Compensation Total stock-based compensation expense was recognized in our condensed consolidated statements of operations and comprehensive loss as follows (in thousands): For the Three Months Ended September 30, For the Nine Months Ended September 30, 2021 2020 2021 2020 Research and development $ 872 $ 336 $ 2,342 $ 539 General and administrative 1,171 542 3,509 973 Total stock-based compensation $ 2,043 $ 878 $ 5,851 $ 1,512 Note 7. Business Acquisition On September 14, 2020 , the Company acquired Anelixis pursuant to that certain Agreement and Plan of Merger, dated September 14, 2020 (the “ Merger Agreement ”), by and among Eledon, Nautilus Merger Sub 1, Inc., a Delaware corporation and wholly owned subsidiary of Eledon (“ First Merger Sub ”), Nautilus Merger Sub 2, LLC, a Delaware limited liability company and wholly owned subsidiary of Eledon (“ Second Merger Sub ”), and Anelixis. Pursuant to the Merger Agreement, First Merger Sub merged with and into Anelixis, pursuant to which Anelixis was the surviving entity and became a wholly owned subsidiary of Eledon (the “ First Merger ”). Immediately following the First Merger, Anelixis merged with and into Second Merger Sub, pursuant to which Second Merger Sub was the surviving entity (the “ Second Merger, ” together with the First Merger, the “ Merger ”). The Merger is intended to qualify as a tax-free reorganization for U.S. federal income tax purposes . Following the acquisition of Anelixis, the Company has continued to maintain its corporate headquarters in Southern California and maintain research and development facilities in the Boston area. Under the terms of the Merger Agreement, at the closing of the Merger, Eledon issued to the stockholders of Anelixis 175,488 shares of the common stock of Eledon, par value $ 0.001 per share and 140,026 shares of newly designated Series X 1 Preferred Stock. Subject to stockholder approval, each share of Series X 1 Preferred Stock is convertible into approximately 55.5556 shares of common stock. The preferences, rights and limitations applicable to the Series X 1 Preferred Stock are set forth in the Certificate of Designation, as filed with the SEC. In addition to the common stock and preferred stock issued, certain outstanding warrants issued and equity awards granted by Anelixis were not settled upon completion of the merger, and instead were assumed and then replaced with Eledon warrants and equity awards. The amounts for the assumed and replaced warrants and equity awards attributed to pre-merger services are included in other consideration amounts transferred and added to goodwill. The Company determined that FASB Accounting Standards Codification Topic 805 (“ASC 805”), Business Combinations , is the authoritative guidance in accounting for this transaction and for determining whether Anelixis was a dormant, non-operating entity that would not meet the definition of a business under ASC 805. If Anelixis was not an operating entity, the acquisition would instead be considered a capital transaction and equivalent to the issuance of shares by Eledon for the net monetary assets of Anelixis accompanied by a recapitalization. Conversely, if Anelixis was determined to be a business, the acquisition method of accounting would apply and the difference between the acquisition date fair value of the total consideration transferred and the aggregate values assigned to the assets acquired and liabilities assumed would be recorded as goodwill. The Company evaluated the terms of the Merger Agreement and the transaction under the applicable accounting guidance and determined that Anelixis satisfied the definition of a business under ASC 805 and as further clarified by ASU 2017-01. Based on this analysis, the Company accounted for the acquisition of Anelixis as a business combination under the acquisition method of accounting as it had determined that Anelixis’ assets acquired in the transaction included an input and a substantive process that together significantly contributed to the ability to create outputs. Additionally, the Company was determined to be both the legal and accounting acquirer as it had issued equity interests to acquire all of Anelixis’ equity interests. Goodwill generated from the acquisition was primarily attributable to the expected synergies from combining 20 operations and expanding market potential, together with certain intangible assets that do not qualify for separate recognition. None of the approximately $ 48.6 million in goodwill is expected to be deductible for tax purposes. Concurrently and in connection with the execution of the Merger Agreement, the Company entered into the Purchase Agreement with certain institutional and accredited investors. Pursuant to the Stock Purchase Agreement, the Company agreed to sell an aggregate of approximately 199,112 shares of Series X 1 Preferred Stock for an aggregate purchase price of approximately $ 99.1 million in the Financing (collectively, the “Financing”). Eledon had commitments for an additional $ 9.0 million in equity financing that was contingent upon the satisfaction of certain incremental closing conditions, including stockholders’ approval of the issuance of the Company’s common stock upon the conversion of the Company’s Series X 1 Preferred Stock and the effective registration of its common stock. The merger was a pre-requisite in order for the Financing to transpire; without the merger, those certain institutional and accredited investors would not have purchased the Company’s Series X 1 convertible preferred stock. On December 18, 2020, the Company held the Special Meeting, whereby the Company’s stockholders approved the issuance of the Company’s common stock, upon conversion of the Company’s Series X 1 Preferred Stock, par value $ 0.001 per share, issued in September 2020. As a result, approximately 231,068 shares of Series X 1 Preferred Stock were converted into 12,837,056 shares of the Company’s common stock. As of September 30, 2021 and December 31, 2020, approximately 108,070 shares of Series X 1 Preferred Stock remain outstanding. On December 23, 2020, the Company sold 1,004,111 shares of its common stock for gross proceeds of $ 9.0 million that was contingent upon the satisfaction of certain incremental closing conditions, as described above. Acquisition Consideration The following table summarizes the fair value of purchase price consideration to acquire Anelixis (in thousands): Description Amount Fair value of purchase consideration: Common shares issued (1) $ 1,194 Preferred shares issued (2) 69,723 Options assumed (3) 2,950 Warrants assumed (3) 12,944 Total purchase consideration $ 86,811 (1) The fair value of common shares issued in the merger is based on 175,488 shares issued on the September 14, 2020 acquisition date at the closing price of the Company's common stock of $ 6.80 per share. (2) The fair value of preferred shares issued in the merger is based on the amount per share of Series X 1 preferred stock in the September 2020 Purchase Agreement. (3) The fair value of the options and warrants assumed and replaced in the merger is based on applying the Black-Scholes valuation method using appropriate inputs of volatility rates ranging from 82 % to 83 %, expected terms of 5.0 to 5.9 years and risk-free rates of 0.27 % to 0.45 %. 21 Purchase Price Allocation The following is an allocation of purchase price as of the September 14, 2020, acquisition closing date based upon an estimate of the fair value of the assets acquired and the liabilities assumed by the Company in the acquisition (in thousands): Description Amount Cash and cash equivalents $ 11,035 Prepaid expenses and other current assets 26 Other non-current assets 11 Accounts payable ( 580 ) Accrued expenses and other liabilities ( 205 ) Deferred tax liability ( 4,510 ) Net identifiable assets acquired 5,777 Goodwill 48,648 Identifiable intangible assets 32,386 Net assets acquired $ 86,811 Acquisition costs of approximately $ 2.9 million were included in general and administrative expenses in the Company’s consolidated statements of operations and comprehensive loss for the year ended December 31, 2020. Deferred Income Taxes The net deferred tax liability was based upon the difference between the estimated book basis and tax basis of net assets acquired and an estimate for the final pre-acquisition net operating losses of Anelixis. Identifiable Intangible Assets Through its acquisition of Anelixis, the Company acquired intangible assets that consisted of in-process research and development (“IPR&D”) with an estimated fair value of $ 32.4 million, related to its clinical development program of AT-1501. The estimated fair value of the IPR&D was determined by management based on external valuation specialists’ analysis of replacement costs to recreate AT-1501 in its current clinical stage. The replacement cost method contemplates the cost to recreate the utility of AT-1501 but in a form that is not a replica of AT-1501. In this method, the replacement cost is determined and reduced for depreciation of the asset. In this context, depreciation has three components: (i) physical deterioration, (ii) functional obsolescence, and (iii) economic obsolescence. Goodwill Under the acquisition method of accounting, goodwill of approximately $ 48.6 million would be generated after accounting for Anelixis’ assets acquired, liabilities assumed, and intangible assets identified and valued. Pro Forma Information (Unaudited) The following unaudited pro forma combined financial information is presented to illustrate the estimated effects of the Merger based on the historical financial statements and accounting records of Eledon and Anelixis after giving effect to the Merger and the Merger-related pro forma adjustments. Three Months Ended September 30, Nine Months Ended September 30, 2020 2020 Revenue $ 120 $ 120 Net loss and other comprehensive loss $ ( 5,375 ) $ ( 19,140 ) 22 The unaudited pro forma combined statements of operations for the three and nine months ended September 30, 2020 combine the historical statements of operations of Eledon and Anelixis, giving effect to the Merger as if it had occurred on January 1, 2020, the first day of the fiscal year ended December 31, 2020. The unaudited pro forma combined financial information has been presented for informational purposes only. The unaudited pro forma combined financial information does not purport to represent the actual results of operations that Eledon and Anelixis would have achieved had the companies been combined during the periods presented in the unaudited pro forma combined financial statements and is not intended to project the future results of operations that the combined company may achieve after the Merger. The unaudited pro forma combined financial information does not reflect any potential cost savings that may be realized as a result of the Merger and also does not reflect any restructuring or integration-related costs to achieve those potential cost savings. Additionally, the unaudited pro forma combined financial information does not reflect any merger-related expenses , which totaled approximately $ 2.7 million during the three and nine months ended September 30, 2020 . There were no merger related expenses during the periods ended September 30, 2021. Anelixis has not recognized any revenue since its acquisition by the Company. 8. Subsequent Events The Company has evaluated events subsequent to September 30, 2021 through the filing date of this Quarterly Report on Form 10-Q. Any material subsequent events that occurred during this time have been properly recognized or disclosed in the condensed consolidated financial statements and accompanying notes. 23