Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 10, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2022 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | ELDN | |
Entity Registrant Name | ELEDON PHARMACEUTICALS, INC. | |
Entity Central Index Key | 0001404281 | |
Entity Current Reporting Status | Yes | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Shell Company | false | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding | 13,756,788 | |
Entity File Number | 001-36620 | |
Entity Tax Identification Number | 20-1000967 | |
Entity Address, Address Line One | 19900 MacArthur Blvd | |
Entity Address, Address Line Two | Suite 550 | |
Entity Address, City or Town | Irvine | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 92612 | |
City Area Code | (949) | |
Local Phone Number | 238-8090 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Incorporation, State or Country Code | DE | |
Title of 12(b) Security | Common Stock, $0.001 par value | |
Security Exchange Name | NASDAQ | |
Entity Interactive Data Current | Yes |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 65,889 | $ 84,833 |
Prepaid expenses and other current assets | 1,676 | 3,513 |
Total current assets | 67,565 | 88,346 |
Operating lease asset, net | 832 | 768 |
Goodwill | 48,648 | 48,648 |
In-process research and development | 32,386 | 32,386 |
Other assets | 155 | 400 |
Total assets | 149,586 | 170,548 |
Current liabilities: | ||
Accounts payable | 3,859 | 1,813 |
Current operating lease liability | 378 | 369 |
Accrued expenses and other liabilities | 2,043 | 2,219 |
Total current liabilities | 6,280 | 4,401 |
Deferred tax liability | 1,752 | 1,752 |
Non-current operating lease liability | 461 | 400 |
Total liabilities | 8,493 | 6,553 |
Commitments and contingencies (Note 5) | ||
Stockholders’ equity: | ||
Common stock, $0.001 par value, 200,000,000 shares authorized at March 31, 2022 and December 31, 2021; 13,756,788 and 14,306,788 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively | 14 | 14 |
Additional paid-in capital | 285,560 | 278,880 |
Accumulated deficit | (144,481) | (114,899) |
Total stockholders’ equity | 141,093 | 163,995 |
Total liabilities and stockholders’ equity | 149,586 | 170,548 |
Series X1 Non-voting Convertible Preferred Stock [Member] | ||
Stockholders’ equity: | ||
Preferred stock, value | ||
Series X Non-voting Convertible Preferred Stock [Member] | ||
Stockholders’ equity: | ||
Preferred stock, value |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 13,756,788 | 14,306,788 |
Common stock, shares outstanding | 13,756,788 | 14,306,788 |
Series X1 Non-voting Convertible Preferred Stock [Member] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 515,000 | 515,000 |
Preferred stock, shares issued | 117,970 | 108,070 |
Preferred stock, shares outstanding | 117,970 | 108,070 |
Series X Non-voting Convertible Preferred Stock [Member] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000 | 10,000 |
Preferred stock, shares issued | 6,204 | 6,204 |
Preferred stock, shares outstanding | 6,204 | 6,204 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Operating expenses | ||||
Research and development | $ 7,452 | $ 7,658 | $ 19,830 | $ 17,553 |
General and administrative | 3,146 | 2,848 | 9,910 | 9,929 |
Total operating expenses | 10,598 | 10,506 | 29,740 | 27,482 |
Loss from operations | (10,598) | (10,506) | (29,740) | (27,482) |
Other income/(expense), net | 127 | 3 | 158 | 7 |
Loss before income tax benefit | (10,471) | (10,503) | (29,582) | (27,475) |
Income tax benefit | 686 | 1,775 | ||
Net loss and comprehensive loss | $ (10,471) | $ (9,817) | $ (29,582) | $ (25,700) |
Net loss per share, basic | $ (0.73) | $ (0.66) | $ (2.07) | $ (1.73) |
Net loss per share, diluted | $ (0.73) | $ (0.66) | $ (2.07) | $ (1.73) |
Weighted Average Number of Shares Outstanding, Basic | 14,265,905 | 14,815,852 | 14,289,729 | 14,820,822 |
Weighted Average Number of Shares Outstanding, Diluted | 14,265,905 | 14,815,852 | 14,289,729 | 14,820,822 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-In Capital [Member] | Accumulated Deficit [Member] | Series X1 Non-voting Convertible Preferred Stock [Member] | Series X Non Voting Convertible Preferred Stock [Member] |
Beginning Balance at Dec. 31, 2020 | $ 190,596 | $ 15 | $ 270,974 | $ (80,393) | ||
Beginning Balance, Shares at Dec. 31, 2020 | 15,160,397 | 108,070 | ||||
Cancellation of common stock in connection with exchange for preferred stock, Shares | (344,666) | 6,204 | ||||
Cancellation of common stock in connection with exchange for warrants | $ (1) | 1 | ||||
Cancellation of common stock in connection with exchange for warrants, Shares | (509,117) | |||||
Stock-based compensation | 5,851 | 5,851 | ||||
Stock options exercised | 1 | 1 | ||||
Stock options exercised, Shares | 174 | |||||
Net loss and other comprehensive loss | (25,700) | (25,700) | ||||
Ending Balance at Sep. 30, 2021 | 170,748 | $ 14 | 276,827 | (106,093) | ||
Ending Balance, Shares at Sep. 30, 2021 | 14,306,788 | 108,070 | 6,204 | |||
Beginning Balance at Jun. 30, 2021 | 178,521 | $ 14 | 274,783 | (96,276) | ||
Beginning Balance, Shares at Jun. 30, 2021 | 14,306,614 | 108,070 | 6,204 | |||
Stock-based compensation | 2,043 | 2,043 | ||||
Stock options exercised | 1 | 1 | ||||
Stock options exercised, Shares | 174 | |||||
Net loss and other comprehensive loss | (9,817) | (9,817) | ||||
Ending Balance at Sep. 30, 2021 | 170,748 | $ 14 | 276,827 | (106,093) | ||
Ending Balance, Shares at Sep. 30, 2021 | 14,306,788 | 108,070 | 6,204 | |||
Beginning Balance at Dec. 31, 2021 | 163,995 | $ 14 | 278,880 | (114,899) | ||
Beginning Balance, Shares at Dec. 31, 2021 | 14,306,788 | 108,070 | 6,204 | |||
Cancellation of common stock in connection with exchange for warrants | 1 | 1 | ||||
Cancellation of common stock in connection with exchange for preferred stock, Shares | (550,000) | 9,900 | ||||
Stock-based compensation | 6,679 | 6,679 | ||||
Net loss and other comprehensive loss | (29,582) | (29,582) | ||||
Ending Balance at Sep. 30, 2022 | 141,093 | $ 14 | 285,560 | (144,481) | ||
Ending Balance, Shares at Sep. 30, 2022 | 13,756,788 | 117,970 | 6,204 | |||
Beginning Balance at Jun. 30, 2022 | 149,379 | $ 14 | 283,375 | (134,010) | ||
Beginning Balance, Shares at Jun. 30, 2022 | 13,756,788 | 117,970 | 6,204 | |||
Stock-based compensation | 2,185 | 2,185 | ||||
Net loss and other comprehensive loss | (10,471) | (10,471) | ||||
Ending Balance at Sep. 30, 2022 | $ 141,093 | $ 14 | $ 285,560 | $ (144,481) | ||
Ending Balance, Shares at Sep. 30, 2022 | 13,756,788 | 117,970 | 6,204 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Operating activities | ||
Net loss | $ (29,582) | $ (25,700) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Amortization of operating lease asset | 280 | 134 |
Stock-based compensation | 6,679 | 5,851 |
Deferred tax liabilities | (1,775) | |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | 2,082 | (55) |
Accounts payable and accrued expenses | 1,871 | 1,980 |
Operating lease liability | (274) | (140) |
Net cash used in operating activities | (18,944) | (19,705) |
Financing activities | ||
Proceeds from exercise of stock options | 1 | |
Offering costs in connection with PIPE transaction | (450) | |
Net cash used in financing activities | (449) | |
Net change in cash and cash equivalents | (18,944) | (20,154) |
Cash and cash equivalents at beginning of period | 84,833 | 114,195 |
Cash and cash equivalents at end of period | 65,889 | 94,041 |
Supplemental disclosure of non-cash investing and financing activities | ||
Common stock exchanged for X1 non-voting convertible preferred stock | 1 | |
Common stock exchanged for warrants | 1 | |
Increase in operating lease asset and liability due to lease modification | $ 344 | $ 219 |
Description of Business
Description of Business | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Description of Business | Note 1. Description of Business Eledon Pharmaceuticals, Inc. (formerly Novus Therapeutics, Inc.) is a clinical stage biopharmaceutical company focused on developing life-changing, targeted medicines for persons living with an autoimmune disease, requiring an organ or cell-based transplant, or living with amyotrophic lateral sclerosis (“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. The Company’s lead compound in development is tegoprubart, an anti-CD40L antibody with high affinity for CD40 ligand, a well-validated biological target with broad therapeutic potential. On September 14, 2020 , Eledon 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. The Company has continued to maintain its corporate headquarters in Southern California and has research and development facilities in Burlington, Massachusetts. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 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, 2021 included in the Annual Report on Form 10-K filed by the Company with the SEC on March 24, 2022. The results of operations and comprehensive loss for the three and nine months ended September 30, 2022 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. 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 $ 10.5 million and $ 29.6 million for the three and nine months ended September 30, 2022, respectively. As of September 30, 2022, the Company had cash and cash equivalents of $ 65.9 million, working capital of $ 61.3 million and an accumulated deficit of $ 144.5 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, 2022 , 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 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 consolidated financial statements and accompanying notes. The most significant estimates in the Company’s consolidated financial statements relate to stock-based compensation, accruals for liabilities, impairment of long-lived assets, including goodwill, and other matters that affect the 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 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. The carrying value of cash equivalents approximates their fair value due to the short-term maturities of these instruments. 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, 2022 and December 31, 2021 . Concentration of Credit Risk and Other Risks and Uncertainties As of September 30, 2022 and December 31, 2021, 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 its 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 the approval by the FDA, there is still an ongoing risk of adverse events that did not appear during the product approval process. 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 our research and development facility is based in Burlington, Massachusetts. We primarily manage 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, or other future health crises, 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 during the three and nine months ended September 30, 2022 . 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 (“RSUs”) 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, 2022 include 509,117 shares underlying warrants to purchase common shares. As the shares underlying these warrants can be issued for 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 For the Nine Months 2022 2021 2022 2021 (In thousands, except share and per share data) Net loss used in the calculation of basic and diluted $ ( 10,471 ) $ ( 9,817 ) $ ( 29,582 ) $ ( 25,700 ) Net loss per share, basic and diluted $ ( 0.73 ) $ ( 0.66 ) $ ( 2.07 ) $ ( 1.73 ) Weighted-average number of common shares, basic 14,265,905 14,815,852 14,289,729 14,820,822 The computation of diluted earnings per share excludes stock options, warrants, and RSUs that are anti-dilutive. As of September 30, 2022 and 2021 , common share equivalents of 8,223,206 shares and 674,295 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 stock options granted to employees, which is an average of the options ordinary vesting period and the contractual term. For stock options granted to the members of the Company’s board of directors (the “Board”), 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 members 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. RSUs and performance-based RSUs (“PRSUs”) are measured and recognized based on the quoted market price of our common stock on the date of grant. In March 2020, the Board 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 a special meeting of its stockholders (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 initially available for issuance under the 2020 Plan was 4,860,000 shares of Common Stock, which represented 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 currently intends that the initial shares under the 2020 Plan will be sufficient to fund the Company’s equity compensation needs for approximately three years from the date of the Special Meeting. The 2014 Plan was closed to new grants following the approval of the 2020 Plan, and therefore, there were no shares reserved for issuance under the 2014 Plan as of September 30, 2022 . The number of shares reserved for issuance under the 2020 Plan and ESPP was 3,167,608 and 24,077 shares, respectively, as of September 30, 2022 . 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. |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 9 Months Ended |
Sep. 30, 2022 | |
Prepaid Expense and Other Assets, Current [Abstract] | |
Prepaid Expenses and Other Current Assets | Note 3. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following (in thousands): September 30, December 31, 2022 2021 Prepaid insurance $ 299 $ 1,344 Prepaid clinical 1,141 2,039 Prepaid other 179 96 Other current assets 57 34 Total prepaid expenses and other current assets $ 1,676 $ 3,513 |
Accrued Expenses and Other Liab
Accrued Expenses and Other Liabilities | 9 Months Ended |
Sep. 30, 2022 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Liabilities | Note 4. Accrued Expenses and Other Liabilities Accrued expenses and other liabilities consisted of the following (in thousands): September 30, December 31, 2022 2021 Accrued compensation and related expenses $ 1,281 $ 1,411 Accrued severance — 104 Accrued clinical 611 454 Accrued professional services 102 167 Accrued other 49 83 Total accrued expenses and other liabilities $ 2,043 $ 2,219 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 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 $ 0.1 million for each of the three months ended September 30, 2022 and 2021 , and $ 0.3 million and $ 0.2 million for the nine months ended September 30, 2022 and 2021, respectively. The Company has an operating lease for 5,197 square feet of office space in Irvine, California, which was set to expire on December 31, 2022 . On August 12, 2022, the Company extended the term of the lease through December 31, 2024, by amending the office lease effective January 1, 2023 . On November 4, 2021, the Company entered into an operating lease for approximately 6,138 square feet of office space in Burlington, Massachusetts, that expires on November 20, 2024 . The Company determines if a contract contains a lease at inception. Our office leases have a remaining term of approximately twenty-seven months and do not include options to extend the leases for additional periods. 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 leases contain 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 agreements do 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: For the Nine Months 2022 2021 Operating lease cost (a) $ 303 $ 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): For the Nine Months 2022 2021 Supplemental Cash Flows Information Cash paid for amounts included in the measurement of lease liability: Operating cash flows from operating lease $ 290 $ 146 Remaining lease term Operating lease 2.20 years 1.25 years Discount rate Operating lease 2.49 % 3.18 % Future payments under noncancelable operating leases having initial or remaining terms of one year or more are as follows for the succeeding fiscal year and thereafter (in thousands): September 30, 2022 2022 (remainder of) $ 97 2023 378 2024 389 Total minimum lease payments 864 Less imputed interest ( 25 ) Present value of lease liabilities 839 Less current portion of operating lease liability ( 378 ) Non-current operating lease liability $ 461 Grants and Licenses ALS Therapy Development Foundation, Inc. License Agreement In May 2015, Anelixis executed a License Agreement (the “ALS Agreement”), which is an exclusive patent rights agreement with ALS Therapy Development Foundation, Inc. (“ALS TDI”) for certain patents and “know-how” of ALS TDI. This ALS Agreement continues until the licensee terminates the agreement with ninety days written notice. The ALS Agreement requires license fees payable to ALS TDI, subject to the achievement of certain milestones and other conditions. The first and second milestones of the ALS 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 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. No milestones were achieved during either the nine months ended September 30, 2022 or the year ended December 31, 2021. The ALS 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 ALS TDI 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 ALS Agreement. Furthermore, the Company shall pay ALS TDI 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 ALS TDI a one-time milestone payment of $ 30.0 million. Lonza Sales AG Inc. License Agreement In September 2018, Anelixis executed a License Agreement (the “Lonza Agreement”), which is a manufacturing know-how rights agreement with Lonza Sales AG Inc. (“Lonza”) for the use of certain processes and know-how related to the manufacture of tegoprubart. The Lonza Agreement continues until the later of the last Valid Claim (as defined therein) or ten years from the First Commercial Sale of tegoprubart, as defined and subject to the conditions therein. A royalty in the low single digits will be due on aggregate net sales of tegoprubart that is manufactured by Lonza or any other third-party or licensee. 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, 2022; therefore, no liability was recorded for the repayment in the accompanying condensed consolidated financial statements. Legal Matters The Company is 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 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. Indemnifications 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, 2022. |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2022 | |
Equity [Abstract] | |
Stockholders' Equity | Note 6. Stockholders’ Equity Equity Distribution Agreement On March 31, 2021, the Company filed a registration statement on Form S-3 containing a prospectus and prospectus supplement under which the Company may offer and sell up to $ 75 million in shares of its common stock, from time to time, pursuant to an open market sale agreement with Jeffries LLC and by any method deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933 (the “ATM Program”). Pursuant to the “baby shelf rules” promulgated by the SEC, if the Company’s public float is less than $ 75.0 million as of specified measurement periods, the number of shares of common stock that may be offered and sold by the Company under a Form S-3 registration statement, including pursuant to the ATM Program, in any twelve-month period is limited to an aggregate amount that does not exceed one-third of the Company’s public float. As of September 30, 2022 , due to the SEC’s “baby shelf rules,” the Company was permitted to sell up to $ 14.8 million of shares of common stock pursuant to the ATM Program. The Company will remain subject to the “baby shelf rules” under the Form S-3 registration statement until such time as its public float exceeds $ 75.0 million. Through September 30, 2022 , no shares of common stock have been sold under the ATM program. Common Stock Warrants As of September 30, 2022 , there were 1,145,631 warrants exercisable into common stock (after rounding for fractional shares and subject to beneficial ownership blockers). Roll Forward of Warrant Activity Registered direct Private placement warrants Private placement warrants, placement agent Warrants exchanged for common stock Warrants exchanged for Series X 1 preferred stock Total Balance as of December 31, 2021 9,581 319,064 9,177 509,117 298,692 1,145,631 Issued — — — — — — Exercised — — — — — — Cancelled/Expired — — — — — — Balance as of September 30, 2022 9,581 319,064 9,177 509,117 298,692 1,145,631 Exchange Agreement On January 11, 2022, the Company entered into an exchange agreement (the “Series X 1 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”), pursuant to which the Series X 1 Exchanging Stockholders exchanged (the “Series X 1 Exchange”) 550,000 shares of the Company’s common stock for 9,899.99 shares of Series X 1 Non-Voting Convertible Preferred Stock. Preferred Stock Warrants As of September 30, 2022 , there were 50,207.419 warrants exercisable into Series X 1 Preferred Stock, which are convertible into 2,789,301 shares of common stock (after rounding for fractional shares and subject to beneficial ownership conversion blockers). Roll Forward of 1 Convertible Total Balance as of December 31, 2021 50,207.419 Assumed and replaced — Exercised — Cancelled/Expired — Balance as of September 30, 2022 50,207.419 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 For the Nine Months 2022 2021 2022 2021 Research and development $ 873 $ 872 $ 2,677 $ 2,342 General and administrative 1,312 1,171 4,002 3,509 Total stock-based compensation $ 2,185 $ 2,043 $ 6,679 $ 5,851 |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 7. Subsequent Events The Company has evaluated events subsequent to September 30, 2022 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. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | 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, 2021 included in the Annual Report on Form 10-K filed by the Company with the SEC on March 24, 2022. The results of operations and comprehensive loss for the three and nine months ended September 30, 2022 are not necessarily indicative of results expected for the full fiscal year or any other future period. |
Principles of Consolidation | 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. |
Liquidity and Financial Condition | 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 $ 10.5 million and $ 29.6 million for the three and nine months ended September 30, 2022, respectively. As of September 30, 2022, the Company had cash and cash equivalents of $ 65.9 million, working capital of $ 61.3 million and an accumulated deficit of $ 144.5 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, 2022 , 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 | Use of Estimates The preparation of the Company’s 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 consolidated financial statements and accompanying notes. The most significant estimates in the Company’s consolidated financial statements relate to stock-based compensation, accruals for liabilities, impairment of long-lived assets, including goodwill, and other matters that affect the 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 consolidated financial statements. |
Cash and Cash Equivalents | 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. The carrying value of cash equivalents approximates their fair value due to the short-term maturities of these instruments. 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, 2022 and December 31, 2021 . |
Concentration of Credit Risk and Other Risks and Uncertainties | Concentration of Credit Risk and Other Risks and Uncertainties As of September 30, 2022 and December 31, 2021, 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 its 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 the approval by the FDA, there is still an ongoing risk of adverse events that did not appear during the product approval process. 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 our research and development facility is based in Burlington, Massachusetts. We primarily manage 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, or other future health crises, 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 | 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 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 during the three and nine months ended September 30, 2022 . |
Net Loss Per Share | 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 (“RSUs”) 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, 2022 include 509,117 shares underlying warrants to purchase common shares. As the shares underlying these warrants can be issued for 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 For the Nine Months 2022 2021 2022 2021 (In thousands, except share and per share data) Net loss used in the calculation of basic and diluted $ ( 10,471 ) $ ( 9,817 ) $ ( 29,582 ) $ ( 25,700 ) Net loss per share, basic and diluted $ ( 0.73 ) $ ( 0.66 ) $ ( 2.07 ) $ ( 1.73 ) Weighted-average number of common shares, basic 14,265,905 14,815,852 14,289,729 14,820,822 The computation of diluted earnings per share excludes stock options, warrants, and RSUs that are anti-dilutive. As of September 30, 2022 and 2021 , common share equivalents of 8,223,206 shares and 674,295 shares were anti-dilutive, respectively. |
Stock-based Compensation | 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 stock options granted to employees, which is an average of the options ordinary vesting period and the contractual term. For stock options granted to the members of the Company’s board of directors (the “Board”), 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 members 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. RSUs and performance-based RSUs (“PRSUs”) are measured and recognized based on the quoted market price of our common stock on the date of grant. In March 2020, the Board 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 a special meeting of its stockholders (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 initially available for issuance under the 2020 Plan was 4,860,000 shares of Common Stock, which represented 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 currently intends that the initial shares under the 2020 Plan will be sufficient to fund the Company’s equity compensation needs for approximately three years from the date of the Special Meeting. The 2014 Plan was closed to new grants following the approval of the 2020 Plan, and therefore, there were no shares reserved for issuance under the 2014 Plan as of September 30, 2022 . The number of shares reserved for issuance under the 2020 Plan and ESPP was 3,167,608 and 24,077 shares, respectively, as of September 30, 2022 . |
Recently Issued or Adopted Accounting Pronouncements | 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. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Schedule of Common Share Equivalents Included from Computation of Net Loss Per Share | As the shares underlying these warrants can be issued for 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 For the Nine Months 2022 2021 2022 2021 (In thousands, except share and per share data) Net loss used in the calculation of basic and diluted $ ( 10,471 ) $ ( 9,817 ) $ ( 29,582 ) $ ( 25,700 ) Net loss per share, basic and diluted $ ( 0.73 ) $ ( 0.66 ) $ ( 2.07 ) $ ( 1.73 ) Weighted-average number of common shares, basic 14,265,905 14,815,852 14,289,729 14,820,822 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Prepaid Expense and Other Assets, Current [Abstract] | |
Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consisted of the following (in thousands): September 30, December 31, 2022 2021 Prepaid insurance $ 299 $ 1,344 Prepaid clinical 1,141 2,039 Prepaid other 179 96 Other current assets 57 34 Total prepaid expenses and other current assets $ 1,676 $ 3,513 |
Accrued Expenses and Other Li_2
Accrued Expenses and Other Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses and Other Liabilities | Accrued expenses and other liabilities consisted of the following (in thousands): September 30, December 31, 2022 2021 Accrued compensation and related expenses $ 1,281 $ 1,411 Accrued severance — 104 Accrued clinical 611 454 Accrued professional services 102 167 Accrued other 49 83 Total accrued expenses and other liabilities $ 2,043 $ 2,219 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Components of Lease Expense | The components of lease expense were as follows: For the Nine Months 2022 2021 Operating lease cost (a) $ 303 $ 145 (a) Includes variable operating lease expenses, which are immaterial |
Schedule of Other Information Related to Leases | Other information related to leases was as follows (in thousands, except lease term and discount rate): For the Nine Months 2022 2021 Supplemental Cash Flows Information Cash paid for amounts included in the measurement of lease liability: Operating cash flows from operating lease $ 290 $ 146 Remaining lease term Operating lease 2.20 years 1.25 years Discount rate Operating lease 2.49 % 3.18 % |
Schedule of Future Payments Under Noncancelable Operating Leases | Future payments under noncancelable operating leases having initial or remaining terms of one year or more are as follows for the succeeding fiscal year and thereafter (in thousands): September 30, 2022 2022 (remainder of) $ 97 2023 378 2024 389 Total minimum lease payments 864 Less imputed interest ( 25 ) Present value of lease liabilities 839 Less current portion of operating lease liability ( 378 ) Non-current operating lease liability $ 461 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Class Of Stock [Line Items] | |
Schedule of Stock-Based Compensation Expense Recognized | 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 For the Nine Months 2022 2021 2022 2021 Research and development $ 873 $ 872 $ 2,677 $ 2,342 General and administrative 1,312 1,171 4,002 3,509 Total stock-based compensation $ 2,185 $ 2,043 $ 6,679 $ 5,851 |
Common Stock Warrants [Member] | |
Class Of Stock [Line Items] | |
Schedule of Warrant Activity | As of September 30, 2022 , there were 1,145,631 warrants exercisable into common stock (after rounding for fractional shares and subject to beneficial ownership blockers). Roll Forward of Warrant Activity Registered direct Private placement warrants Private placement warrants, placement agent Warrants exchanged for common stock Warrants exchanged for Series X 1 preferred stock Total Balance as of December 31, 2021 9,581 319,064 9,177 509,117 298,692 1,145,631 Issued — — — — — — Exercised — — — — — — Cancelled/Expired — — — — — — Balance as of September 30, 2022 9,581 319,064 9,177 509,117 298,692 1,145,631 |
Preferred Stock Warrants [Member] | |
Class Of Stock [Line Items] | |
Schedule of Warrant Activity | As of September 30, 2022 , there were 50,207.419 warrants exercisable into Series X 1 Preferred Stock, which are convertible into 2,789,301 shares of common stock (after rounding for fractional shares and subject to beneficial ownership conversion blockers). Roll Forward of 1 Convertible Total Balance as of December 31, 2021 50,207.419 Assumed and replaced — Exercised — Cancelled/Expired — Balance as of September 30, 2022 50,207.419 |
Description of Business - Addit
Description of Business - Additional Information (Detail) | Sep. 14, 2020 |
Anelixis [Member] | |
Description Of Business [Line Items] | |
Date of acquisition | Sep. 14, 2020 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) | 3 Months Ended | 9 Months Ended | ||||||
Dec. 18, 2020 shares | Sep. 30, 2022 USD ($) $ / shares shares | Sep. 30, 2021 USD ($) shares | Sep. 30, 2022 USD ($) Segment $ / shares shares | Sep. 30, 2021 USD ($) shares | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | Mar. 31, 2020 shares | |
Summary Of Significant Accounting Policies [Line Items] | ||||||||
Net loss | $ | $ (10,471,000) | $ (9,817,000) | $ (29,582,000) | $ (25,700,000) | ||||
Cash and cash equivalents | $ | 65,889,000 | $ 94,041,000 | 65,889,000 | $ 94,041,000 | $ 84,833,000 | $ 114,195,000 | ||
Working capital | $ | 61,300,000 | 61,300,000 | ||||||
Accumulated deficit | $ | (144,481,000) | $ (144,481,000) | (114,899,000) | |||||
Cash, cash equivalents and restricted cash, maturity period | three months or less | |||||||
Cash equivalents | $ | $ 9,200,000 | $ 9,200,000 | $ 9,200,000 | |||||
Number of operating business segments | Segment | 1 | |||||||
Basic weighted average shares outstanding | 14,265,905 | 14,815,852 | 14,289,729 | 14,820,822 | ||||
Warrants exercise price | $ / shares | $ 0.001 | $ 0.001 | ||||||
Antidilutive securities excluded from computation of earnings per share, amount | 8,223,206 | 674,295 | ||||||
2014 Stock Incentive Plan [Member] | ||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||
Increase in number of shares of common stock authorized for issuance | 28,816 | |||||||
Common stock, number of shares initially reserved for issuance | 0 | 0 | ||||||
2014 Employee Stock Purchase Plan [Member] | ||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||
Increase in number of shares of common stock authorized for issuance | 7,204 | |||||||
Common stock, number of shares initially reserved for issuance | 24,077 | 24,077 | ||||||
2020 Plan [Member] | ||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||
Common stock, number of shares initially reserved for issuance | 4,860,000 | 3,167,608 | 3,167,608 | |||||
Percentage of issued and outstanding shares of common stock | 15% | |||||||
Equity compensation period | 3 years | |||||||
Stock Options [Member] | Board of Directors [Member] | ||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||
Expected life assumption using simplified method, description | For stock options granted to the members of the Company’s board of directors (the “Board”), 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 members may be exercised upon termination. | |||||||
Expected life assumption using simplified method | 12 months | |||||||
Stock Options [Member] | Minimum [Member] | Board of Directors [Member] | ||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||
Vesting period of stock options granted | 12 months | |||||||
Stock Options [Member] | Maximum [Member] | Board of Directors [Member] | ||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||
Vesting period of stock options granted | 18 months | |||||||
Warrants [Member] | ||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||
Basic weighted average shares outstanding | 509,117 | |||||||
Anelixis Therapeutics, LLC and Otic Pharma, Ltd. | ||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||
Ownership interest percentage | 100% | |||||||
Otic Pharma, Inc. [Member] | ||||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||||
Ownership interest percentage | 100% |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Common Share Equivalents Included from Computation of Net Loss Per Share (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Earnings Per Share [Abstract] | ||||
Net loss | $ (10,471) | $ (9,817) | $ (29,582) | $ (25,700) |
Net loss per share, basic | $ (0.73) | $ (0.66) | $ (2.07) | $ (1.73) |
Net loss per share, diluted | $ (0.73) | $ (0.66) | $ (2.07) | $ (1.73) |
Weighted-average number of common shares, basic | 14,265,905 | 14,815,852 | 14,289,729 | 14,820,822 |
Weighted-average number of common shares, diluted | 14,265,905 | 14,815,852 | 14,289,729 | 14,820,822 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets - Prepaid Expenses and Other Current Assets (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Prepaid Expense and Other Assets, Current [Abstract] | ||
Prepaid insurance | $ 299 | $ 1,344 |
Prepaid clinical | 1,141 | 2,039 |
Prepaid other | 179 | 96 |
Other current assets | 57 | 34 |
Total prepaid expenses and other current assets | $ 1,676 | $ 3,513 |
Accrued Expenses and Other Li_3
Accrued Expenses and Other Liabilities - Schedule of Accrued Expenses and Other Liabilities (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Accrued Liabilities and Other Liabilities [Abstract] | ||
Accrued compensation and related expenses | $ 1,281 | $ 1,411 |
Accrued severance | 104 | |
Accrued clinical | 611 | 454 |
Accrued professional services | 102 | 167 |
Accrued other | 49 | 83 |
Total accrued expenses and other liabilities | $ 2,043 | $ 2,219 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||
Aug. 12, 2022 | Nov. 04, 2021 ft² | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) ft² Milestone | Sep. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) Milestone | Dec. 31, 2018 USD ($) | Dec. 31, 2017 USD ($) | Dec. 31, 2015 USD ($) | |
Other Commitments [Line Items] | ||||||||||
Rental expense | $ 100,000 | $ 100,000 | $ 300,000 | $ 200,000 | ||||||
Effective date of lease amendment | Jan. 01, 2023 | |||||||||
Remaining term of office lease | 27 months | |||||||||
Indemnification obligations amount | 0 | $ 0 | ||||||||
Contingent Liabilities | 0 | $ 0 | ||||||||
Office of Chief Scientist of Israeli Ministry of Economy and Industry [Member] | ||||||||||
Other Commitments [Line Items] | ||||||||||
Grants received | $ 500,000 | |||||||||
ALS Therapy Development Foundation, Inc. License Agreement [Member] | ||||||||||
Other Commitments [Line Items] | ||||||||||
Fee due for milestones achieved | $ 1,000,000 | $ 1,000,000 | ||||||||
Common stock issued in lieu of making a cash payment | $ 1,000,000 | $ 1,000,000 | ||||||||
Number of Milestones Achieved | Milestone | 0 | 0 | ||||||||
Remaining milestone payments for first licensed product | 6,000,000 | $ 6,000,000 | ||||||||
Annual License Maintenance Fee | $ 100,000 | |||||||||
ALS Therapy Development Foundation, Inc. License Agreement [Member] | Achievement of 500 Million Aggregate Sales [Member] | ||||||||||
Other Commitments [Line Items] | ||||||||||
Reaching of aggregate net sales | 500,000,000 | |||||||||
Amount of one-time milestone payment | 15,000,000 | 15,000,000 | ||||||||
ALS Therapy Development Foundation, Inc. License Agreement [Member] | Achievement of 1 Billion Aggregate Sales [Member] | ||||||||||
Other Commitments [Line Items] | ||||||||||
Reaching of aggregate net sales | 1,000,000,000 | |||||||||
Amount of one-time milestone payment | 30,000,000 | 30,000,000 | ||||||||
Maximum [Member] | ALS Therapy Development Foundation, Inc. License Agreement [Member] | ||||||||||
Other Commitments [Line Items] | ||||||||||
Development and regulatory milestone payments | $ 2,500,000 | $ 2,500,000 | ||||||||
Irvine, California [Member] | ||||||||||
Other Commitments [Line Items] | ||||||||||
Area of office space | ft² | 5,197 | |||||||||
Lease expiration date | Dec. 31, 2022 | |||||||||
Burlington, Massachusetts [Member] | ||||||||||
Other Commitments [Line Items] | ||||||||||
Area of office space | ft² | 6,138 | |||||||||
Lease expiration date | Nov. 20, 2024 |
Commitments and Contingencies_2
Commitments and Contingencies - Components of Lease Expense (Detail) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating lease cost | $ 303 | $ 145 |
Commitments and Contingencies_3
Commitments and Contingencies - Schedule of Other Information Related to Leases (Detail) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Cash paid for amounts included in the measurement of lease liability: | ||
Operating cash flows from operating lease | $ 290 | $ 146 |
Remaining lease term | ||
Operating lease | 2 years 2 months 12 days | 1 year 3 months |
Discount rate | ||
Operating lease | 2.49% | 3.18% |
Commitments and Contingencies_4
Commitments and Contingencies - Schedule of Future Payments Under Noncancelable Operating Leases (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Commitments and Contingencies Disclosure [Abstract] | ||
2022 (remainder of) | $ 97 | |
2023 | 378 | |
2024 | 389 | |
Total minimum lease payments | 864 | |
Less imputed interest | (25) | |
Present value of lease liabilities | 839 | |
Less current portion of operating lease liability | (378) | $ (369) |
Non-current operating lease liability | $ 461 | $ 400 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) $ in Millions | 9 Months Ended | ||
Jan. 11, 2022 | Sep. 30, 2022 | Mar. 31, 2021 | |
Series X1 Preferred Stock [Member] | |||
Class Of Stock [Line Items] | |||
Warrants available for exercise | 50,207.419 | ||
Shares of common stock issued upon conversion of each share of preferred stock | 2,789,301 | ||
Common Stock [Member] | |||
Class Of Stock [Line Items] | |||
Warrants available for exercise | 1,145,631 | ||
BVF Exchanging Stockholders [Member] | Series X1 Exchange Agreement [Member] | Series X1 Non-voting Convertible Preferred Stock [Member] | |||
Class Of Stock [Line Items] | |||
Conversion of stock, shares issued | 9,899.99 | ||
BVF Exchanging Stockholders [Member] | Common Stock [Member] | Series X1 Exchange Agreement [Member] | |||
Class Of Stock [Line Items] | |||
Conversion of stock, shares converted | 550,000 | ||
ATM Program [Member] | Jeffries LLC [Member] | |||
Class Of Stock [Line Items] | |||
Equity distribution agreement maximum value of common shares issuable | $ 75 | ||
Public float minimum balance to be maintained | $ 75 | ||
Common stock number of shares issued | 0 | ||
ATM Program [Member] | Maximum [Member] | Jeffries LLC [Member] | |||
Class Of Stock [Line Items] | |||
Equity distribution agreement maximum value of common shares issuable | $ 14.8 |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Warrant Activity (Detail) - Common Stock Warrants [Member] | 9 Months Ended |
Sep. 30, 2022 shares | |
Class Of Warrant Or Right [Line Items] | |
Beginning Balance | 1,145,631 |
Issued | 0 |
Exercised | 0 |
Cancelled/Expired | 0 |
Ending Balance | 1,145,631 |
Registered Direct Warrants, Placement Agent [Member] | |
Class Of Warrant Or Right [Line Items] | |
Beginning Balance | 9,581 |
Issued | 0 |
Exercised | 0 |
Cancelled/Expired | 0 |
Ending Balance | 9,581 |
Private Placement Warrants [Member] | |
Class Of Warrant Or Right [Line Items] | |
Beginning Balance | 319,064 |
Issued | 0 |
Exercised | 0 |
Cancelled/Expired | 0 |
Ending Balance | 319,064 |
Private Placement Warrants, Placement Agent [Member] | |
Class Of Warrant Or Right [Line Items] | |
Beginning Balance | 9,177 |
Issued | 0 |
Exercised | 0 |
Cancelled/Expired | 0 |
Ending Balance | 9,177 |
Warrants Exchanged for Common Stock [Member] | |
Class Of Warrant Or Right [Line Items] | |
Beginning Balance | 509,117 |
Issued | 0 |
Exercised | 0 |
Cancelled/Expired | 0 |
Ending Balance | 509,117 |
Warrants Exchanged for Series X1 Preferred Stock [Member] | |
Class Of Warrant Or Right [Line Items] | |
Beginning Balance | 298,692 |
Issued | 0 |
Exercised | 0 |
Cancelled/Expired | 0 |
Ending Balance | 298,692 |
Stockholders' Equity - Schedu_2
Stockholders' Equity - Schedule of Series X1 Convertible Preferred Stock Warrant Activity (Detail) - Preferred Stock Warrants [Member] | 9 Months Ended |
Sep. 30, 2022 shares | |
Class Of Warrant Or Right [Line Items] | |
Beginning Balance | 50,207.419 |
Assumed and replaced | 0 |
Exercised | 0 |
Cancelled/Expired | 0 |
Ending Balance | 50,207.419 |
Stockholders' Equity - Schedu_3
Stockholders' Equity - Schedule of Stock-Based Compensation Expense Recognized (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation | $ 2,185 | $ 2,043 | $ 6,679 | $ 5,851 |
Research and Development [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation | 873 | 872 | 2,677 | 2,342 |
General and Administrative [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation | $ 1,312 | $ 1,171 | $ 4,002 | $ 3,509 |