Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2021 | Oct. 29, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2021 | |
Document Transition Report | false | |
Entity File Number | 001-36201 | |
Entity Registrant Name | Immunic, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 56-2358443 | |
Entity Address, Address Line One | 1200 Avenue of the Americas | |
Entity Address, Address Line Two | Suite 200 | |
Entity Address, City or Town | New York, | |
Entity Address, State or Province | NY | |
Entity Address, Postal Zip Code | 10036 | |
City Area Code | 332 | |
Local Phone Number | 255-9818 | |
Title of 12(b) Security | Common Stock, $0.0001 par value | |
Trading Symbol | IMUX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 26,249,439 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Central Index Key | 0001280776 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 110,444 | $ 127,452 |
Other current assets and prepaid expenses | 12,051 | 6,293 |
Total current assets | 122,495 | 133,745 |
Property and equipment, net | 196 | 203 |
Goodwill | 32,970 | 32,970 |
Right-of-use assets, net | 1,054 | 901 |
Other long-term assets | 42 | 42 |
Total assets | 156,757 | 167,861 |
Current liabilities: | ||
Accounts payable | 3,241 | 3,700 |
Accrued expenses | 6,771 | 4,318 |
Other current liabilities | 579 | 379 |
Total current liabilities | 10,591 | 8,397 |
Long term liabilities | ||
Operating lease liabilities | 701 | 679 |
Total long-term liabilities | 701 | 679 |
Total liabilities | 11,292 | 9,076 |
Commitments and contingencies (Note 4) | ||
Stockholders’ equity: | ||
Preferred stock, $0.0001 par value; 20,000,000 authorized and no shares issued or outstanding at September 30, 2021 and December 31, 2020 | 0 | 0 |
Common stock, $0.0001 par value; 130,000,000 shares authorized and 26,249,439 and 21,168,240 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively | 3 | 2 |
Additional paid-in capital | 321,950 | 266,823 |
Accumulated other comprehensive loss | (800) | (4,112) |
Accumulated deficit | (175,688) | (103,928) |
Total stockholders’ equity | 145,465 | 158,785 |
Total liabilities and stockholders’ equity | $ 156,757 | $ 167,861 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in USD per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 20,000,000 | 20,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in USD per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 130,000,000 | 130,000,000 |
Common stock, shares issued (in shares) | 26,249,439 | 21,168,240 |
Common stock, shares outstanding (in shares) | 26,249,439 | 21,168,240 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Operating expenses: | ||||
Research and development | $ 15,480 | $ 11,040 | $ 42,737 | $ 27,461 |
General and administrative | 2,907 | 2,505 | 9,957 | 7,320 |
4SC Royalty Settlement (see Note 4) | 0 | 0 | 17,250 | 0 |
Total operating expenses | 18,387 | 13,545 | 69,944 | 34,781 |
Loss from operations | (18,387) | (13,545) | (69,944) | (34,781) |
Other income (expense): | ||||
Interest income | 10 | 20 | 51 | 48 |
Other income (expense), net | (915) | 612 | (1,867) | 1,875 |
Total other income (expense) | (905) | 632 | (1,816) | 1,923 |
Net loss | $ (19,292) | $ (12,913) | $ (71,760) | $ (32,858) |
Net loss per share, basic and diluted (in USD per share) | $ (0.76) | $ (0.70) | $ (3.33) | $ (2.35) |
Weighted-average common shares outstanding, basic and diluted (in shares) | 25,320,091 | 18,405,840 | 21,559,964 | 13,966,690 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (19,292) | $ (12,913) | $ (71,760) | $ (32,858) |
Other comprehensive income (loss): | ||||
Foreign currency translation | 598 | (144) | 3,312 | (379) |
Total comprehensive loss | $ (18,694) | $ (13,057) | $ (68,448) | $ (33,237) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders’ Equity - USD ($) $ in Thousands | Total | July 2021 Equity Issuance | April 2020 Equity Issuances | June 2020 Equity Issuances | At the Market Sales Agreement | August 2020 Equity Issuances | Common Stock | Common StockJuly 2021 Equity Issuance | Common StockApril 2020 Equity Issuances | Common StockJune 2020 Equity Issuances | Common StockAt the Market Sales Agreement | Common StockAugust 2020 Equity Issuances | Additional Paid-In Capital | Additional Paid-In CapitalJuly 2021 Equity Issuance | Additional Paid-In CapitalApril 2020 Equity Issuances | Additional Paid-In CapitalJune 2020 Equity Issuances | Additional Paid-In CapitalAt the Market Sales Agreement | Additional Paid-In CapitalAugust 2020 Equity Issuances | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2019 | 10,744,806 | |||||||||||||||||||
Beginning balance at Dec. 31, 2019 | $ 58,363 | $ 1 | $ 119,646 | $ (1,373) | $ (59,911) | |||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||||||||
Net loss | (8,487) | (8,487) | ||||||||||||||||||
Stock-based compensation | 353 | 353 | ||||||||||||||||||
Foreign exchange translation adjustment | (309) | (309) | ||||||||||||||||||
Issuance of common stock (in shares) | 78,745 | |||||||||||||||||||
Issuance of common stock | 568 | 568 | ||||||||||||||||||
Ending balance (in shares) at Mar. 31, 2020 | 10,823,551 | |||||||||||||||||||
Ending balance at Mar. 31, 2020 | 50,488 | $ 1 | 120,567 | (1,682) | (68,398) | |||||||||||||||
Beginning balance (in shares) at Dec. 31, 2019 | 10,744,806 | |||||||||||||||||||
Beginning balance at Dec. 31, 2019 | 58,363 | $ 1 | 119,646 | (1,373) | (59,911) | |||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||||||||
Net loss | (32,858) | |||||||||||||||||||
Issuance of common stock (in shares) | 283,828 | |||||||||||||||||||
Issuance of common stock | $ 2,900 | |||||||||||||||||||
Ending balance (in shares) at Sep. 30, 2020 | 20,718,340 | |||||||||||||||||||
Ending balance at Sep. 30, 2020 | 162,875 | $ 2 | 257,394 | (1,752) | (92,769) | |||||||||||||||
Beginning balance (in shares) at Mar. 31, 2020 | 10,823,551 | |||||||||||||||||||
Beginning balance at Mar. 31, 2020 | 50,488 | $ 1 | 120,567 | (1,682) | (68,398) | |||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||||||||
Net loss | (11,458) | (11,458) | ||||||||||||||||||
Stock-based compensation | 369 | 369 | ||||||||||||||||||
Foreign exchange translation adjustment | 74 | 74 | ||||||||||||||||||
Issuance of common stock (in shares) | 1,764,706 | 2,175,000 | 205,083 | |||||||||||||||||
Issuance of common stock | $ 13,918 | $ 23,048 | $ 2,246 | $ 13,918 | $ 23,048 | $ 2,246 | ||||||||||||||
Ending balance (in shares) at Jun. 30, 2020 | 14,968,340 | |||||||||||||||||||
Ending balance at Jun. 30, 2020 | 78,685 | $ 1 | 160,148 | (1,608) | (79,856) | |||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||||||||
Net loss | (12,913) | (12,913) | ||||||||||||||||||
Stock-based compensation | 707 | 707 | ||||||||||||||||||
Foreign exchange translation adjustment | (144) | (144) | ||||||||||||||||||
Issuance of common stock (in shares) | 5,750,000 | |||||||||||||||||||
Issuance of common stock | $ 96,540 | $ 1 | $ 96,539 | |||||||||||||||||
Ending balance (in shares) at Sep. 30, 2020 | 20,718,340 | |||||||||||||||||||
Ending balance at Sep. 30, 2020 | 162,875 | $ 2 | 257,394 | (1,752) | (92,769) | |||||||||||||||
Beginning balance (in shares) at Dec. 31, 2020 | 21,168,240 | |||||||||||||||||||
Beginning balance at Dec. 31, 2020 | 158,785 | $ 2 | 266,823 | (4,112) | (103,928) | |||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||||||||
Net loss | (34,534) | (34,534) | ||||||||||||||||||
Stock-based compensation | 1,579 | 1,579 | ||||||||||||||||||
Foreign exchange translation adjustment | 2,991 | 2,991 | ||||||||||||||||||
Issuance of common stock (in shares) | 581,199 | |||||||||||||||||||
Issuance of common stock | 8,625 | 8,625 | ||||||||||||||||||
Ending balance (in shares) at Mar. 31, 2021 | 21,749,439 | |||||||||||||||||||
Ending balance at Mar. 31, 2021 | 137,446 | $ 2 | 277,027 | (1,121) | (138,462) | |||||||||||||||
Beginning balance (in shares) at Dec. 31, 2020 | 21,168,240 | |||||||||||||||||||
Beginning balance at Dec. 31, 2020 | 158,785 | $ 2 | 266,823 | (4,112) | (103,928) | |||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||||||||
Net loss | (71,760) | |||||||||||||||||||
Ending balance (in shares) at Sep. 30, 2021 | 26,249,439 | |||||||||||||||||||
Ending balance at Sep. 30, 2021 | 145,465 | $ 3 | 321,950 | (800) | (175,688) | |||||||||||||||
Beginning balance (in shares) at Mar. 31, 2021 | 21,749,439 | |||||||||||||||||||
Beginning balance at Mar. 31, 2021 | 137,446 | $ 2 | 277,027 | (1,121) | (138,462) | |||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||||||||
Net loss | (17,934) | (17,934) | ||||||||||||||||||
Stock-based compensation | 1,507 | 1,507 | ||||||||||||||||||
Foreign exchange translation adjustment | (277) | (277) | ||||||||||||||||||
Ending balance (in shares) at Jun. 30, 2021 | 21,749,439 | |||||||||||||||||||
Ending balance at Jun. 30, 2021 | 120,742 | $ 2 | 278,534 | (1,398) | (156,396) | |||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||||||||
Net loss | (19,292) | (19,292) | ||||||||||||||||||
Stock-based compensation | 1,397 | 1,397 | ||||||||||||||||||
Foreign exchange translation adjustment | 598 | 598 | ||||||||||||||||||
Issuance of common stock (in shares) | 4,500,000 | |||||||||||||||||||
Issuance of common stock | $ 42,020 | $ 1 | $ 42,019 | |||||||||||||||||
Ending balance (in shares) at Sep. 30, 2021 | 26,249,439 | |||||||||||||||||||
Ending balance at Sep. 30, 2021 | $ 145,465 | $ 3 | $ 321,950 | $ (800) | $ (175,688) |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Stockholders’ Equity (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | |
Issuance costs | $ 37 | |||
July 2021 Equity Issuance | ||||
Issuance costs | $ 2,980 | |||
April 2020 Equity Issuances | ||||
Issuance costs | $ 1,082 | |||
June 2020 Equity Issuances | ||||
Issuance costs | 1,752 | |||
At the Market Sales Agreement | ||||
Issuance costs | $ 75 | |||
August 2020 Equity Issuances | ||||
Issuance costs | $ 6,960 |
Condensed Consolidated Statem_5
Condensed Consolidated Statement of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Cash flows from operating activities: | ||
Net loss | $ (71,760) | $ (32,858) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 45 | 63 |
Unrealized foreign currency loss | 3,202 | 0 |
Stock-based compensation | 4,483 | 1,429 |
Common Stock issued in connection with the 4SC royalty settlement (see Note 4) | 8,625 | 0 |
Changes in operating assets and liabilities: | ||
Other current assets and prepaid expenses | (6,305) | (1,234) |
Accounts payable | (261) | 875 |
Accrued expenses | 2,760 | 772 |
Other liabilities | (341) | (1,208) |
Net cash used in operating activities | (59,552) | (32,161) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (48) | (122) |
Net cash used in investing activities | (48) | (122) |
Cash flows from financing activities: | ||
Net cash provided by financing activities | 42,020 | 136,320 |
Effect of exchange rate changes on cash and cash equivalents | 572 | (223) |
Net change in cash and cash equivalents | (17,008) | 103,814 |
Cash and cash equivalents, beginning of period | 127,452 | 29,369 |
Cash and cash equivalents, end of period | 110,444 | 133,183 |
Supplemental disclosure of noncash investing and financing activities: | ||
Common Stock issued in connection with the 4SC royalty settlement (see Note 4) | 8,625 | 0 |
Operating lease right-of use asset obtained in exchange for lease obligation | 435 | 0 |
Offering costs in accrued expenses | 0 | 25 |
Public Offering | ||
Cash flows from financing activities: | ||
Proceeds from issuance of common stock | 0 | 2,814 |
April 2020 Equity Issuances | ||
Cash flows from financing activities: | ||
Proceeds from issuance of common stock | 0 | 13,918 |
June 2020 Equity Issuances | ||
Cash flows from financing activities: | ||
Proceeds from issuance of common stock | 0 | 23,048 |
August 2020 Public Equity Offering | ||
Cash flows from financing activities: | ||
Proceeds from issuance of common stock | 0 | 96,540 |
July 2021 Public Equity Offering | ||
Cash flows from financing activities: | ||
Proceeds from issuance of common stock | $ 42,020 | $ 0 |
Condensed Consolidated Statem_6
Condensed Consolidated Statements of Cash Flows (Parenthetical) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Public Offering | ||
Issuance costs | $ 112 | |
April 2020 Equity Issuances | ||
Issuance costs | 1,082 | |
June 2020 Equity Issuances | ||
Issuance costs | 1,752 | |
August 2020 Public Equity Offering | ||
Issuance costs | $ 6,960 | |
July 2021 Public Equity Offering | ||
Issuance costs | $ 2,980 |
Description of Business and Bas
Description of Business and Basis of Financial Statements | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Description of Business and Basis of Financial Statements | Description of Business and Basis of Financial Statements Description of Business Immunic, Inc. ("Immunic" or the "Company") is a clinical-stage biopharmaceutical company with a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases, including relapsing-remitting multiple sclerosis (“RRMS”), ulcerative colitis (“UC”), Crohn’s disease (“CD”) and psoriasis. The Company’s main operations are in Gräfelfing near Munich, Germany. Immunic currently has approximately 52 employees. Immunic is currently pursuing three development programs. These include the IMU-838 program, which is focused on the development of oral formulations of a small molecule inhibitor of the enzyme dihydroorotate dehydrogenase (“DHODH”); the IMU-935 program, which is focused on an inverse agonist of retinoic acid receptor-related orphan nuclear receptor gamma truncated (“RORγt”), an immune cell-specific isoform of RORγ; and the IMU-856 program, which involves the development of a drug targeting the restoration of intestinal barrier function and regeneration of bowel epithelium. In addition to these large markets, these products are also being developed to address certain rare diseases with high unmet medical needs, such as primary sclerosing cholangitis (“PSC”) and Guillain-Barré syndrome (“GBS”), as well as metastatic castration-resistant prostate cancer (“mCRPC”). The Company’s business, operating results, financial condition and growth prospects are subject to significant risks and uncertainties, including the failure of its clinical trials to meet their endpoints, failure to obtain regulatory approval and needing additional funding to complete the development and commercialization of the Company's three development programs. Liquidity and Financial Condition Immunic has no products approved for commercial sale and has not generated any revenue from product sales. It has never been profitable and has incurred operating losses in each year since inception in 2016. The Company has an accumulated deficit of approximately $175.7 million as of September 30, 2021 and $103.9 million as of December 31, 2020. Substantially all of Immunic's operating losses resulted from expenses incurred in connection with its research and development programs and from general and administrative costs associated with its operations. Immunic expects to incur significant expenses and increasing operating losses for the foreseeable future as it initiates and continues the preclinical and clinical development of its product candidates and adds personnel necessary to advance its clinical pipeline of product candidates. Immunic expects that its operating losses will fluctuate significantly from quarter-to-quarter and year-to-year due to timing of clinical development programs. From inception through September 30, 2021, Immunic has raised net cash of approximately $258.8 million from private and public offerings of preferred and common stock. As of September 30, 2021, Immunic had cash and cash equivalents of approximately $110.4 million. With these funds, Immunic expects to be able to fund its operations beyond twelve months from the date of the issuance of the accompanying condensed consolidated financial statements. Basis of Presentation and Consolidation The accompanying condensed consolidated financial statements have been prepared in conformity with United States generally accepted accounting principles, ("U.S. GAAP") and include the accounts of Immunic and its wholly-owned subsidiaries, Immunic AG and Immunic Research GmbH (which both began operations in 2016) and Immunic Australia Pty Ltd. (which began operations in 2018). All intercompany accounts and transactions have been eliminated in consolidation. Immunic manages its operations as a single reportable segment for the purposes of assessing performance and making operating decisions. Certain prior period amounts have been reclassified to conform to the current basis of presentation. Unaudited Interim Financial Information Immunic has prepared the accompanying interim unaudited condensed consolidated financial statements in accordance with United States generally accepted accounting principles, (“US GAAP”), for interim financial information and with the instructions to Form 10-Q and Regulation S-X of the SEC. Accordingly, they do not include all of the information and |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires the Company to make certain estimates and assumptions that affect the reported amounts of assets, liabilities, expenses and the disclosure of contingent assets and liabilities in the Company’s consolidated financial statements. The most significant estimates in the Company’s financial statements and accompanying notes relate to clinical trial expenses and share-based compensation. Management believes its estimates to be reasonable under the circumstances. Actual results could differ materially from those estimates and assumptions. Foreign Currency Translation and Presentation The Company’s reporting currency is United States (“U.S.”) dollars. Immunic AG and Immunic Research GmbH’s operations are located in Germany with the euro being their functional currency. Immunic Australia Pty Ltd.’s functional currency is the Australian dollar. All amounts in the financial statements where the functional currency is not the U.S. dollar are translated into U.S. dollar equivalents at exchange rates as follows: • assets and liabilities at reporting period-end rates; • income statement accounts at average exchange rates for the reporting period; and • components of equity at historical rates. Gains and losses from translation of the financial statements into U.S. dollars are recorded in stockholders’ equity as a component of accumulated other comprehensive income (loss). Realized and unrealized gains and losses resulting from foreign currency transactions denominated in currencies other than the functional currency are reflected as general and administrative expenses in the Consolidated Statements of Operations. Foreign currency transaction gains and losses related to long-term intercompany loans that are payable in the foreseeable future are recorded in Other Income (Expense). The Consolidated Statements of Cash Flows were prepared by using the average exchange rate in effect during the reporting period which reasonably approximates the timing of the cash flows. Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents. Cash and cash equivalents consist of cash on hand and deposits in banks located in the U.S., Germany and Australia. The Company maintains cash and cash equivalent balances denominated in Euro and U.S. dollars with major financial institutions in the U.S. and Germany in excess of the deposit limits insured by the government. Management periodically reviews the credit standing of these financial institutions and believes that the Company is not exposed to any significant credit risk. The Company currently deposits its cash and cash equivalents with two large financial institutions. Fair Value Measurement Fair value is defined as the price that would be received to sell an asset or be paid to transfer a liability in an orderly transaction between market participants on the measurement date. Accounting guidance establishes a fair value hierarchy that requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The standard describes three levels of inputs that may be used to measure fair value: Level 1—Quoted prices in active markets for identical assets or liabilities. Level 1 assets consisted of money market funds for the periods presented. The Company had no Level 1 liabilities for the periods presented. Level 2— Inputs other than observable quoted prices for the asset or liability, either directly or indirectly; these include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active. The Company had no Level 2 assets or liabilities for the periods presented. Level 3—Unobservable inputs to the valuation methodology that are significant to the measurement of the fair value of assets or liabilities. The Company had no Level 3 assets or liabilities for the periods presented. The carrying value of cash and cash equivalents, other current assets and prepaid expenses, accounts payable, accrued expenses, and other current liabilities approximates fair value due to the short period of time to maturity. Property and Equipment Property and equipment is stated at cost. Depreciation is computed using the straight-line method based on the estimated service lives of the assets, which range from three Impairment of Long-Lived Assets The Company records impairment losses on long-lived assets used in operations when indicators of impairment are present and the undiscounted cash flows estimated to be generated by those assets are less than the assets’ carrying amount. Impaired assets are then recorded at their estimated fair value. There were no impairment losses during the three and nine months ended September 30, 2021 and 2020. Goodwill Business combinations are accounted for under the acquisition method. The total purchase price of an acquisition is allocated to the underlying identifiable net assets, based on their respective estimated fair values as of the acquisition date. Determining the fair value of assets acquired and liabilities assumed requires management’s judgment and often involves the use of significant estimates and assumptions, including assumptions with respect to future cash inflows and outflows, probabilities of success, discount rates, and asset lives, among other items. Assets acquired and liabilities assumed are recorded at their estimated fair values. The excess of the purchase price over the estimated fair values of the net assets acquired is recorded as goodwill. Goodwill is tested for impairment at the reporting unit level annually in the fourth quarter, or more frequently when events or changes in circumstances indicate that the asset might be impaired. Examples of such events or circumstances include, but are not limited to, a significant adverse change in legal or business climate, an adverse regulatory action or unanticipated competition. The Company assesses qualitative factors to determine whether the existence of events or circumstances would indicate that it is more likely than not that the fair value of the reporting unit is less than its carrying amount. If after assessing the totality of events or circumstances, the Company were to determine that it is more likely than not that the fair value of the reporting unit is less than its carrying amount, then the Company would perform a quantitative test that compares the fair value to its carrying value to determine the amount of any impairment. Impairment testing for goodwill is done at the reporting unit level. The Company has determined that it operates in a single operating segment and has a single reporting unit. The Company has determined there was no goodwill impairment as of September 30, 2021. Research and Development Expenses These costs primarily include external development expenses and internal personnel expenses for the three development programs, IMU-838, IMU-935 and IMU-856. Immunic has spent the majority of its research and development resources on IMU-838, the Company's lead development program for clinical trials in RRMS, UC, COVID-19, and PSC. Research and development expenses consist of expenses incurred in research and development activities, which include clinical trials, contract research services, certain milestone payments, salaries and related employee benefits, allocated facility costs and other outsourced services. Research and development expenses are charged to operations as incurred. The Company enters into agreements with contract research organizations (“CROs”) to provide clinical trial services for individual studies and projects by executing individual work orders governed by a Master Service Arrangement (“MSA”). The MSAs and associated work orders provide for regular recurrent payments and payments upon the completion of certain milestones. The Company regularly assesses the timing of payments against actual costs incurred to ensure a proper accrual of related expenses in the appropriate accounting period. Collaboration Arrangements Certain collaboration and license agreements may include payments to or from the Company of one or more of the following: non-refundable or partially refundable upfront or license fees; development, regulatory and commercial milestone payments; payment for manufacturing supply services; partial or complete reimbursement of research and development costs; and royalties on net sales of licensed products. The Company assesses whether such contracts are within the scope of Financial Accounting Standards Board (FASB) Accounting Standards Update (“ASU”) 2014-09 “ Revenue from Contracts with Customers ” and ASU No. 2018-18, “ Collaborative Arrangements”, ("ASU 2018-18"). ASU 2018-18, clarifies that certain elements of collaborative arrangements could qualify as transactions with customers in the scope of ASC 606. In October 2018, the Company entered into an option and license agreement (the "Daiichi Sankyo Agreement") with Daiichi Sankyo Co., Ltd. ("Daiichi Sankyo") which granted the Company the right to license a group of compounds, designated by the Company as IMU-856, as a potential new oral treatment option for diseases such as inflammatory bowel disease, irritable bowel syndrome with diarrhea, immune checkpoint inhibitor induced colitis and other barrier function associated diseases. During the option period, the Company performed agreed upon research and development activities for which it was reimbursed by Daiichi Sankyo up to a maximum agreed-upon limit. Such reimbursement was recorded as other income. There are no more research and development reimbursements expected under this agreement. General and Administrative Expenses General and administrative expenses consist primarily of salaries and related costs for personnel in executive, finance, business development and other support functions. Other general and administrative expenses include, but are not limited to, stock-based compensation, insurance costs, professional fees for legal, accounting and tax services, consulting, related facility costs and travel. Stock-Based Compensation The Company measures the cost of employee and non-employee services received in exchange for equity awards based on the grant-date fair value of the award recognized generally as an expense (i) on a straight-line basis over the requisite service period for those awards whose vesting is based upon a service condition, and (ii) on an accelerated method for awards whose vesting is based upon a performance condition, but only to the extent it is probable that the performance condition will be met. Stock-based compensation is (i) estimated at the date of grant based on the award’s fair value for equity classified awards and (ii) final measurement date for liability classified awards. Forfeitures are recorded in the period in which they occur. The Company estimates the fair value of stock options using the Black-Scholes-Merton option-pricing model ("BSM"), which requires the use of estimates and subjective assumptions, including the risk-free interest rate, the fair value of the underlying common stock, the expected dividend yield of the Company’s common stock, the expected volatility of the price of the Company’s common stock, and the expected term of the option. These estimates involve inherent uncertainties and the application of management’s judgment. If factors change and different assumptions are used, the Company’s stock-based compensation expense could be materially different in the future. Leases The Company leases office space and office equipment. The underlying lease agreements have lease terms of less than 12 months and up to 60 months. Leases with terms of 12 months or less at inception are not included in the operating lease right of use asset and operating lease liability. The Company has two existing leases for office space. At inception of a lease agreement, the Company determines whether an agreement represents a lease and at commencement each lease agreement is assessed as to classification as an operating or financing lease. The Company's two leases have been classified as operating leases and an operating lease right-of-use asset and an operating lease liability have been recorded on the Company’s balance sheet. A right-of-use lease asset represents the Company’s right to use the underlying asset for the lease term and the lease obligation represents its commitment to make the lease payments arising from the lease. Right-of-use lease assets and obligations are recognized at the commencement date based on the present value of remaining lease payments over the lease term. As the Company’s leases do not provide an implicit rate, the Company has used an estimated incremental borrowing rate based on the information available at the commencement date in determining the present value of lease payments. The right-of-use lease asset includes any lease payments made prior to commencement and excludes any lease incentives. The lease term used in estimating future lease payments may include options to extend when it is reasonably certain that the Company will exercise that option. Operating lease expense is recognized on a straight-line basis over the lease term, subject to any changes in the lease or changes in expectations regarding the lease term. Variable lease costs such as common area costs and property taxes are expensed as incurred. Leases with an initial term of twelve months or less are not recorded on the balance sheet. Comprehensive Income (Loss) Comprehensive income (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. Accumulated other comprehensive income (loss) has been reflected as a separate component of stockholders’ equity in the accompanying Consolidated Balance Sheets and consists of foreign currency translation adjustments (net of tax). Income Taxes The Company is subject to corporate income tax laws and regulations in the U.S., Germany and Australia. Tax regulations within each jurisdiction are subject to the interpretation of the related tax laws and regulations and require significant judgment in their application. The Company utilizes the asset and liability method of accounting for income taxes which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the consolidated financial statements. Deferred income tax assets and liabilities are determined based on the differences between the financial statement and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of changes in tax rates on deferred tax assets and liabilities is recognized in operations in the period that includes the enactment date. Deferred taxes are reduced by a valuation allowance when, in the opinion of management, it is more likely than not some portion or the entire deferred tax asset will not be realized. As of September 30, 2021 and 2020, respectively, the Company maintained a full valuation allowance against the balance of deferred tax assets. It is the Company’s policy to provide for uncertain tax positions and the related interest and penalties based upon management’s assessment of whether a tax benefit is more likely than not to be sustained upon examination by tax authorities. The Company recognizes interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense. The Company is subject to U.S. federal, New York, California, Texas, German and Australian income taxes. The Company is subject to U.S. federal or state income tax examination by tax authorities for tax returns filed for the years 2003 and forward due to the carryforward of NOLs. Tax years 2016 through 2020 are subject to audit by German and Australian tax authorities. The Company is not currently under examination by any tax jurisdictions. Net Loss Per Share Basic net loss per share attributable to common stockholders is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share attributable to common stockholders is computed by dividing the net loss by the weighted-average number of common shares and, if dilutive, common stock equivalents outstanding for the period determined using the treasury-stock method. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Company’s net loss position. Potentially dilutive securities, not included in the calculation of diluted net loss per share attributable to common stockholders because to do so would be anti-dilutive, are as follows: As of September 30, 2021 2020 Options to purchase common stock 2,045,960 969,822 Recently Issued and/or Adopted Accounting Standards There are no recently issued accounting standards that would have a significant impact on the company's consolidated financial statements. |
Balance Sheet Details
Balance Sheet Details | 9 Months Ended |
Sep. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Balance Sheet Details | Balance Sheet Details Other Current Assets and Prepaid Expenses Other Current Assets and Prepaid Expenses consist of (in thousands): September 30, 2021 December 31, 2020 Prepaid clinical and related costs $ 7,872 $ 3,416 VAT receivable 310 295 Australian research and development tax incentive 2,594 1,348 Other 1,275 1,234 Total $ 12,051 $ 6,293 Accounts Payable Accounts Payable consist of (in thousands): September 30, 2021 December 31, 2020 Clinical costs $ 2,867 $ 3,408 Legal and audit costs 101 139 Other 273 153 Total $ 3,241 $ 3,700 Accrued Expenses Accrued expenses consist of (in thousands): September 30, 2021 December 31, 2020 Accrued clinical and related costs $ 6,012 $ 3,301 Accrued legal and audit costs 67 114 Accrued compensation 528 658 Accrued other 164 245 Total $ 6,771 $ 4,318 Other Current Liabilities Other Current Liabilities consist of (in thousands): September 30, 2021 December 31, 2020 Lease liabilities $ 406 $ 297 Other 173 82 Total 579 379 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Operating Leases The Company leases certain office space under non-cancelable operating leases. The leases terminate on April 30, 2023 for the New York City office and June 30, 2025 for the Gräfelfing, Germany office. The Company formerly leased office space in Planegg-Martinsried, Germany pursuant to a modified lease that terminated on August 31, 2020. These leases include both lease (e.g., fixed rent) and non-lease components (e.g., common-area and other maintenance costs). The non-lease components are deemed to be executory costs and are therefore excluded from the minimum lease payments used to determine the present value of the operating lease obligation and related right-of-use asset. The New York City lease has renewal options, but they were not included in calculating the right of use asset and liabilities. On April 7, 2020, the Company signed a five year lease for its facility in Gräfelfing, Germany. On March 1, 2021 the Company added additional lease space at the Gräfelfing, Germany office. Renewal options were not included in calculating the right of use asset and liabilities for this facility. The leases do not have concessions, leasehold improvement incentives or other build-out clauses. Further, the leases do not contain contingent rent provisions. The New York City lease had a six month rent holiday at the beginning of the lease. There were net additions to right of use assets of $427,000 as a result of signing the Gräfelfing, Germany lease and shortening the term of the Planegg-Martinsried, Germany lease during the year ended December 31, 2020 and net additions of $435,000 with the signing of additional lease space in March 2021. The leases do not provide an implicit rate and, due to the lack of a commercially salable product, the Company is generally considered unable to obtain commercial credit. Therefore, the Company estimated its incremental interest rate to be 6%, considering the quoted rates for the lowest investment-grade debt and the interest rates implicit in recent financing leases. Immunic used its estimated incremental borrowing rate and other information available at the lease commencement date in determining the present value of the lease payments. Immunic’s operating lease costs and variable lease costs were $133,000 and 108,000 for the three months ended September 30, 2021 and 2020, respectively and $372,000 and $267,000 for the nine months ended September 30, 2021 and 2020, respectively. Variable lease costs consist primarily of common area maintenance costs, insurance and taxes which are paid based upon actual costs incurred by the lessor. Maturities of the operating lease obligation are as follows as of September 30, 2021 (in thousands): 2021 115 2022 461 2023 312 2024 238 2025 119 Total 1,245 Interest 105 PV of obligation 1,140 Contractual Obligations As of September 30, 2021, the Company has non-cancelable contractual obligations under certain agreements related to its development programs IMU-838, IMU-935 and IMU-856 totaling approximately $2.2 million, which is expected to be paid through 2023. Other Commitments and Obligations In May 2016, the Company entered into a purchase agreement (the “Agreement”) with 4SC AG, whereby the Company acquired certain assets, including the rights to patents and patent applications, trademarks and know-how. This transaction has been accounted for as an asset acquisition under Accounting Standards Update 2017-01 - Business Combinations (Topic 805): Clarifying the Definition of a Business. The Agreement included payments (Tranches III and IV) that were contingent upon the occurrence of certain events and required the Company to pay royalties equal to 4.4% of the aggregated net sales for a certain period as defined in the Agreement (Tranche III) upon commercialization of the acquired assets. Effective April 12, 2019, the parties agreed to settle Tranche IV by issuing 120,070 shares of the Company’s common stock, immediately following the Transaction, to 4SC AG while keeping Tranche III in effect. Approximately $1.5 million of expense was recorded as a result of the issuance of these shares on April 12, 2019. On March 31, 2021, Immunic AG, a wholly-owned subsidiary of the Company, and 4SC AG entered into a Settlement Agreement, pursuant to which Immunic AG settled its remaining obligation of the 4.4% royalty on net sales for $17.25 million (Tranche III of the Agreement). The payment was made 50% in cash and 50% in shares of Immunic’s common stock (the “Shares”). Pursuant to the Agreement, the Company filed a resale shelf registration statement on Form S-3 covering the resale of the Shares. With the execution of the Agreement, no further payment obligations remain between Immunic AG and 4SC AG. Legal Proceedings The Company is not currently a party to any litigation, nor is it aware of any pending or threatened litigation, that it believes would materially affect its business, operating results, financial condition or cash flows. However, its industry is characterized by frequent claims and litigation including securities litigation, claims regarding patent and other intellectual property rights and claims for product liability. As a result, in the future, the Company may be involved in various legal proceedings from time to time. |
Fair Value
Fair Value | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value | Fair Value The following fair value hierarchy tables present information about each major category of the Company’s financial assets and liabilities measured at fair value on a recurring basis (in thousands): Fair Value Measurement at September 30, 2021 Fair Value Level 1 Level 2 Level 3 Assets Money market funds $ 72,626 $ 72,626 $ — $ — Total assets at fair value $ 72,626 $ 72,626 $ — $ — Fair Value Measurement at Fair Value Measurement at December 31, 2020 Fair Value Level 1 Level 2 Level 3 Assets Money market funds $ 39,615 $ 39,615 $ — $ — Total assets $ 39,615 $ 39,615 $ — $ — There were no transfers between Level 1, Level 2 or Level 3 assets during the periods presented. For the Company’s money market funds, which are included as a component of cash and cash equivalents on the consolidated balance sheet, realized gains and losses are included in interest income (expense) on the consolidated statements of operations. |
Common Stock
Common Stock | 9 Months Ended |
Sep. 30, 2021 | |
Equity [Abstract] | |
Common Stock | Common Stock Shelf Registration Statement In May 2018, Vital Therapies filed a shelf registration statement on Form S-3 (the “2018 Shelf Registration Statement”), which became effective in June 2018. The 2018 Shelf Registration Statement permitted the offering, issuance and sale of up to $200.0 million of common stock, preferred stock, warrants, debt securities, and/or units in one or more offerings and in any combination. This registration statement expired in June 2021 and is no longer effective. In November 2020, Immunic filed a shelf registration statement on Form S-3. The 2020 Shelf Registration Statement permits the offering, issuance and sale of up to $250.0 million of common stock, preferred stock, warrants, debt securities, and/or units in one or more offerings and in any combination of the foregoing. In July 2019, the Company filed a Prospectus Supplement for the offering, issuance and sale of up to a maximum aggregate offering price of $40.0 million of common stock that may be issued and sold under an at-the-market sales agreement ("July 2019 ATM") with SVB Leerink LLC (“SVB Leerink”) as agent. The Company used the net proceeds from the offering to continue to fund the ongoing clinical development of its product candidates and for other general corporate purposes, including funding existing and potential new clinical programs and product candidates. The July 2019 ATM was effectively terminated in June 2021 when the 2018 Shelf Registration Statement expired. In December 2020, the Company filed another Prospectus Supplement for the offering, issuance and sale of up to a maximum aggregate offering price of $50.0 million of common stock that may be issued and sold under another at-the-market sales agreement ("December 2020 ATM") with SVB Leerink as agent. The Company intends to use the net proceeds from the offering to continue to fund the ongoing clinical development of its product candidates and for other general corporate purposes, including funding existing and potential new clinical programs and product candidates. The December 2020 ATM will terminate upon the earlier of (i) the issuance and sale of all of the shares through SVB Leerink on the terms and subject to the conditions set forth in the December 2020 ATM or (ii) termination of the December 2020 ATM as otherwise permitted thereby. The December 2020 ATM may be terminated at any time by either party upon ten days’ prior notice, or by SVB Leerink at any time in certain circumstances, including the occurrence of a material adverse effect on the Company. As of September 30, 2021, $50.0 million in capacity remains under the December 2020 ATM. The Company has agreed to pay SVB Leerink a commission equal to 3.0% of the gross proceeds from the sales of common shares pursuant to the ATM and has agreed to provide SVB Leerink with customary indemnification and contribution rights. The Company did not have any ATM activity during the three and nine months ended September 30, 2021. The Company did not use the ATM in the three months ended September 30, 2020. In the nine months ended September 30, 2020, the Company raised gross proceeds of $2.9 million pursuant to the ATM through the sale of 283,828 shares of common stock at a weighted average price of $10.31 per share. The net proceeds from the ATM were $2.8 million after deducting agent commissions of $87,766 and estimated offering expenses of $23,996. Public Equity Offerings July 2021 Public Equity Offering On July 15, 2021, the Company entered into an underwriting agreement with Piper Sandler & Co., in connection with the Company’s public offering of 4,500,000 shares of the Company’s common stock, $0.0001 par value per share, at a public offering price of $10.00 per share. On July 19, 2021, the Company closed the Offering. The net proceeds to the Company from the Offering was approximately $42.0 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. August 2020 Offering On August 4, 2020, the Company entered into an underwriting agreement with SVB Leerink LLC, as representative of the several underwriters in connection with the Company’s public offering of 5,000,000 shares of common stock, at a public offering price of $18.00 per share. Under the terms of the Underwriting Agreement, the Company granted the Underwriters an option, exercisable for 30 days, to purchase up to an additional 750,000 shares of Common Stock at the public offering price, less underwriting discounts and commissions, which was exercised in full on August 6, 2020. On August 7, 2020, the Company closed the Offering. The net proceeds to the Company from the Offering, after giving effect to the exercise in full by the Underwriters of their option to purchase the Option Shares, was approximately $96.5 million, after deducting underwriting discounts and commissions and offering expenses payable by the Company. June 2020 Offering On June 10, 2020, the Company entered into a placement agency agreement with RCP and Ladenburg Thalmann & Co. Inc. relating to the Company’s public offering of 2,175,000 shares of common stock. Pursuant to this agreement, the Company agreed to pay the placement agents a cash fee of 6.5% of the gross proceeds from the offering raised from investors and to reimburse the placement agents for certain costs incurred in connection therewith. In addition, on June 10, 2020, the Company and certain institutional investors entered into securities purchase agreements relating to the issuance and sale of an aggregate of 2,175,000 shares of the Company’s common stock. The purchase price per share in the Offering was $11.40 for aggregate gross proceeds to the Company of approximately $25.0 million. The net proceeds to the Company from this offering, after deducting the Company’s offering expenses, were approximately $23.0 million. April 2020 Registered Direct Offering On April 23, 2020, the Company entered into an engagement letter with ROTH Capital Partners, LLC ("RCP") relating to the Company’s registered direct offering of common stock to select institutional investors. Pursuant to this agreement, the Company agreed to pay RCP a cash fee of 6.5% of the gross proceeds from the offering raised from investors and to reimburse RCP for certain costs incurred in connection therewith. In addition, on April 23, 2020, the Company and the investors entered into a securities purchase agreement relating to the issuance and sale of an aggregate of 1,764,706 shares of the Company’s common stock. The purchase price per share was $8.50 for aggregate gross proceeds to the Company of approximately $15.0 million. This securities purchase agreement restricted the Company from issuing additional common stock for a period of 75 days from April 27, 2020, subject to certain exceptions. The net proceeds to the Company from this offering, after deducting the Company’s offering expenses, were approximately $13.9 million. Common Stock As of September 30, 2021, the Company’s certificate of incorporation, as amended and restated, authorized the Company to issue 130,000,000 shares of common stock, par value of $0.0001 per share. The voting, dividend and liquidation rights of the holders of the Company’s common stock are subject to and qualified by the rights, powers and preferences of any holders of preferred stock. Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. Common stockholders are entitled to receive dividends, as may be declared by the Board of Directors, if any. Through September 30, 2021, no cash dividends had been declared or paid. Preferred Stock The Company’s certificate of incorporation, as amended and restated, authorizes the Company to issue 20 million shares of $0.0001 par value preferred stock, rights and preferences to be set by the Board of Directors. No preferred shares were outstanding as of September 30, 2021. Stock Reserved for Future Issuance Shares reserved for future issuance at September 30, 2021 are as follows: Number of Common stock reserved for issuance for: 2021 Employee stock Purchase Plan 200,000 Outstanding stock options 2,045,960 Common stock options available for future grant: 2014 Equity Incentive Plan 43,311 2017 Inducement Equity Incentive Plan 46,250 2019 Omnibus Equity Incentive Plan 794,090 Total common shares reserved for future issuance 3,129,611 |
Stock-Based Compensation Plans
Stock-Based Compensation Plans | 9 Months Ended |
Sep. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Compensation Plans | Stock-Based Compensation Plans 2021 Employee Stock Purchase Plan On April 25, 2021, the Company adopted the 2021 Employee Stock Purchase Plan, which was approved by stockholder vote at the 2021 Annual Meeting of Stockholders held on June 10, 2021. The plan provides eligible employees of the Company with an opportunity to purchase common stock of the Company through accumulated payroll deductions, which are included in other current liabilities until they are used to purchase Company shares. Eligible employees participating in the bi-annual offering period can choose to have up to the lesser of 15% of their annual base earnings or the IRS annual share purchase limit of $25,000 in aggregate market value to purchase shares of the Company’s common stock. The purchase price of the stock is the lesser of (i) 85% of the closing market price on the date of purchase and (ii) the closing market price at the beginning of the bi-annual offering period. The maximum number of shares reserved for delivery under the plan is 200,000 shares. The first enrollment period under the plan commenced on August 1, 2021 and the Company recognized $18,000 of expense related to the plan in the three and nine months ended September 30, 2021. Stock Option Programs In July 2019, the Company’s stockholders approved the 2019 Omnibus Equity Incentive Plan (the “2019 Plan”) which was adopted by the Board with an effective date of June 14, 2019. The 2019 Plan allows for the grant of equity awards to employees, consultants and non-employee directors. An initial maximum of 1,500,000 shares of the Company’s common stock are available for grant under the 2019 Plan. The 2019 Plan includes an evergreen provision that allows for the annual addition of up to 4% of the Company’s fully-diluted outstanding stock, with a maximum allowable increase of 4,900,000 shares over the term of the 2019 Plan. In accordance with this provision, the shares available for grant were increased in 2020 and 2021 by a total of 1,340,050 shares. The 2019 Plan is currently administered by the Board, or, at the discretion of the Board, by a committee of the Board, which determines the exercise prices, vesting schedules and other restrictions of awards under the 2019 Plan at its discretion. Options to purchase stock may not have an exercise price that is less than the fair market value of underlying shares on the date of grant, and may not have a term greater than ten years. Incentive stock options granted to employees typically vest over four years. Non-statutory options granted to employees, officers, members of the Board, advisors, and consultants of the Company typically vest over three Shares that are expired, terminated, surrendered or canceled under the 2019 Plan without having been fully exercised will be available for future awards. Movements during the year The following table summarizes stock option activity for the nine months ended September 30, 2021 and 2020, respectively, for the 2019 Plan: Options Weighted- Weighted- Aggregate Outstanding as of January 1, 2021 1,117,160 $ 12.96 Granted 1,033,809 $ 14.95 Exercised — $ — — Forfeited or expired (105,009) $ 14.32 Outstanding as of September 30, 2021 2,045,960 $ 13.90 8.91 $ 74,460 Options vested and expected to vest as of September 30, 2021 2,045,960 $ 13.90 8.91 $ 74,460 Options exercisable as of September 30, 2021 665,168 $ 13.39 8.33 $ 43,121 Options Weighted- Weighted- Aggregate Outstanding as of January 1, 2020 456,645 $ 12.57 Granted 597,068 $ 12.24 Exercised — $ — Forfeited or expired (83,891) $ 13.32 Outstanding as of September 30, 2020 969,822 $ 12.31 9.41 $ 6,075,771 Options vested and expected to vest as of September 30, 2020 969,822 $ 12.31 9.41 $ 6,075,771 Options exercisable as of September 30, 2020 167,515 $ 12.51 8.90 $ 1,015,048 Measurement The weighted-average assumptions used in the BSM option pricing model to determine the fair value of the employee and non-employee stock option grants relating to the 2019 Plan were as follows: Risk-Free Interest Rate The risk-free rate assumption is based on U.S. Treasury instruments with maturities similar to the expected term of the stock options. Expected Dividend Yield The Company has not issued any dividends and does not expect to issue dividends over the life of the options. As a result, the Company has estimated the dividend yield to be zero. Expected Volatility Due to the Company’s limited operating history and a lack of company specific historical and implied volatility data, the Company estimates expected volatility based on the historical volatility of a group of comparable companies that are publicly traded. The historical volatility data was computed using the daily closing prices for the selected companies’ shares during the equivalent period of the calculated expected term of the stock-based awards. Expected Term The expected term of options is estimated considering the vesting period at the grant date, the life of the option and the average length of time similar grants have remained outstanding in the past. The weighted-average grant date fair value of stock options granted under the 2019 Plan during the nine months ended September 30, 2021 and 2020 was $11.14 and $8.75, respectively. The following are the underlying assumptions used in the Black-Scholes option pricing model to determine the fair value of stock options granted to employees and to non-employees under this stock plan: Nine Months Ended September 30, 2021 2020 Risk-free interest rate 0.88% 0.43% Expected dividend yield 0% 0% Expected volatility 92.4% 87.1% Expected term of options (years) 5.95 5.93 Stock-Based Compensation Expense Total stock-based compensation expense for all stock awards recognized in the accompanying unaudited condensed consolidated statements of operations is as follows: Three Months Nine Months 2021 2020 2021 2020 Research and development $ 456,000 $ 254,000 $ 1,279,000 $ 450,000 General and administrative 941,000 453,000 3,204,000 979,000 Total $ 1,397,000 $ 707,000 $ 4,483,000 $ 1,429,000 As of September 30, 2021, there was $13.0 million in total unrecognized compensation expense relating to the 2019 Plan to be recognized over a weighted average period of 2.93 years. Summary of Equity Incentive Plans Assumed from Vital Upon completion of the Transaction with Vital on April 12, 2019, Vital’s 2012 Stock Option Plan (the “2012 Plan”), Vital’s 2014 Equity Incentive Plan (the “2014 Plan”) and Vital’s 2017 Inducement Equity Incentive Plan (the “Inducement Plan”), were assumed by the Company. All awards granted under these plans have either been forfeited or expired. There remain 43,311 shares available for grant under the 2014 Plan as of September 30, 2021. In September 2017, Vital’s Board of Directors approved the Inducement Plan, which was amended and restated in November 2017. Under the Inducement Plan 46,250 shares of Vital’s common stock were reserved to be used exclusively for non-qualified grants to individuals who were not previously employees or directors as an inducement material to a grantee's entry into employment within the meaning of Rule 5635(c)(4) of the Nasdaq Listing Rules. No expense was recorded for the plans assumed from Vital during the three and nine months ended September 30, 2021 and 2020, respectively. |
EIB Loan
EIB Loan | 9 Months Ended |
Sep. 30, 2021 | |
Debt Disclosure [Abstract] | |
EIB Loan | EIB LoanOn October 19, 2020, the Company and Immunic AG, its wholly-owned subsidiary, entered into a Finance Contract (the “Loan Agreement”) with the European Investment Bank (“EIB”), pursuant to which EIB agreed to provide Immunic AG with a term loan in an aggregate amount of up to €24.5 million to support the development of Immunic’s lead asset, IMU-838, in moderate coronavirus disease 2019 (“COVID-19”), to be made available to be drawn in three tranches, with the second and third tranches subject to the completion of certain pre-defined milestones. Effective October 20, 2021 the Company terminated this agreement with the EIB and no funds were drawn under this arrangement. |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2021 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Related Party Transactions Executive Chairman Agreement with Duane Nash On April 15, 2020, the compensation committee of the Board of Directors of the Company independently reviewed and approved entering into an employment agreement with the current Chairman of the Board, Duane Nash, MD, JD, MBA (the “Executive Chairman Agreement”) and pursuant to such approval, on April 17, 2020, the Company and Dr. Nash entered into the Executive Chairman Agreement. The Executive Chairman Agreement establishes an “at will” employment relationship pursuant to which Dr. Nash serves as Executive Chairman and contemplated a term that ends on October 15, 2020, which was subsequently extended to April 15, 2021. On April 15, 2021, the Company and Dr. Nash entered into an addendum (the “Agreement”) to extend the term of the Executive Chairman Agreement to April 15, 2022. In connection with the Agreement, the Company made a one-time award to Dr. Nash of an option to purchase 90,000 shares of Company common stock, which will vest monthly commencing on May 15, 2021, and to increase Dr. Nash’s monthly base salary to $27,960 from $25,417. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Consolidation | Basis of Presentation and Consolidation The accompanying condensed consolidated financial statements have been prepared in conformity with United States generally accepted accounting principles, ("U.S. GAAP") and include the accounts of Immunic and its wholly-owned subsidiaries, Immunic AG and Immunic Research GmbH (which both began operations in 2016) and Immunic Australia Pty Ltd. (which began operations in 2018). All intercompany accounts and transactions have been eliminated in consolidation. Immunic manages its operations as a single reportable segment for the purposes of assessing performance and making operating decisions. Certain prior period amounts have been reclassified to conform to the current basis of presentation. Unaudited Interim Financial Information Immunic has prepared the accompanying interim unaudited condensed consolidated financial statements in accordance with United States generally accepted accounting principles, (“US GAAP”), for interim financial information and with the instructions to Form 10-Q and Regulation S-X of the SEC. Accordingly, they do not include all of the information and |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires the Company to make certain estimates and assumptions that affect the reported amounts of assets, liabilities, expenses and the disclosure of contingent assets and liabilities in the Company’s consolidated financial statements. The most significant estimates in the Company’s financial statements and accompanying notes relate to clinical trial expenses and share-based compensation. Management believes its estimates to be reasonable under the circumstances. Actual results could differ materially from those estimates and assumptions. |
Foreign Currency Translation and Presentation | Foreign Currency Translation and Presentation The Company’s reporting currency is United States (“U.S.”) dollars. Immunic AG and Immunic Research GmbH’s operations are located in Germany with the euro being their functional currency. Immunic Australia Pty Ltd.’s functional currency is the Australian dollar. All amounts in the financial statements where the functional currency is not the U.S. dollar are translated into U.S. dollar equivalents at exchange rates as follows: • assets and liabilities at reporting period-end rates; • income statement accounts at average exchange rates for the reporting period; and • components of equity at historical rates. Gains and losses from translation of the financial statements into U.S. dollars are recorded in stockholders’ equity as a component of accumulated other comprehensive income (loss). Realized and unrealized gains and losses resulting from foreign currency transactions denominated in currencies other than the functional currency are reflected as general and administrative expenses in the Consolidated Statements of Operations. Foreign currency transaction gains and losses related to long-term intercompany loans that are payable in the foreseeable future are recorded in Other Income (Expense). The Consolidated Statements of Cash Flows were prepared by using the average exchange rate in effect during the reporting period which reasonably approximates the timing of the cash flows. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents. |
Fair Value Measurement | Fair Value Measurement Fair value is defined as the price that would be received to sell an asset or be paid to transfer a liability in an orderly transaction between market participants on the measurement date. Accounting guidance establishes a fair value hierarchy that requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The standard describes three levels of inputs that may be used to measure fair value: Level 1—Quoted prices in active markets for identical assets or liabilities. Level 1 assets consisted of money market funds for the periods presented. The Company had no Level 1 liabilities for the periods presented. Level 2— Inputs other than observable quoted prices for the asset or liability, either directly or indirectly; these include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active. The Company had no Level 2 assets or liabilities for the periods presented. Level 3—Unobservable inputs to the valuation methodology that are significant to the measurement of the fair value of assets or liabilities. The Company had no Level 3 assets or liabilities for the periods presented. The carrying value of cash and cash equivalents, other current assets and prepaid expenses, accounts payable, accrued expenses, and other current liabilities approximates fair value due to the short period of time to maturity. |
Property and Equipment | Property and EquipmentProperty and equipment is stated at cost. Depreciation is computed using the straight-line method based on the estimated service lives of the assets, which range from three |
Impairment of Long-Lived Assets | Impairment of Long-Lived AssetsThe Company records impairment losses on long-lived assets used in operations when indicators of impairment are present and the undiscounted cash flows estimated to be generated by those assets are less than the assets’ carrying amount. Impaired assets are then recorded at their estimated fair value. |
Goodwill | Goodwill Business combinations are accounted for under the acquisition method. The total purchase price of an acquisition is allocated to the underlying identifiable net assets, based on their respective estimated fair values as of the acquisition date. Determining the fair value of assets acquired and liabilities assumed requires management’s judgment and often involves the use of significant estimates and assumptions, including assumptions with respect to future cash inflows and outflows, probabilities of success, discount rates, and asset lives, among other items. Assets acquired and liabilities assumed are recorded at their estimated fair values. The excess of the purchase price over the estimated fair values of the net assets acquired is recorded as goodwill. Goodwill is tested for impairment at the reporting unit level annually in the fourth quarter, or more frequently when events or changes in circumstances indicate that the asset might be impaired. Examples of such events or circumstances include, but are not limited to, a significant adverse change in legal or business climate, an adverse regulatory action or unanticipated competition. The Company assesses qualitative factors to determine whether the existence of events or circumstances would indicate that it is more likely than not that the fair value of the reporting unit is less than its carrying amount. If after assessing the totality of events or circumstances, the Company were to determine that it is more likely than not that the fair value of the reporting unit is less than its carrying amount, then the Company would perform a quantitative test that compares the fair value to its carrying value to determine the amount of any impairment. Impairment testing for goodwill is done at the reporting unit level. The Company has determined that it operates in a single operating segment and has a single reporting unit. The Company has determined there was no goodwill impairment as of September 30, 2021. |
Research and Development Expenses | Research and Development Expenses These costs primarily include external development expenses and internal personnel expenses for the three development programs, IMU-838, IMU-935 and IMU-856. Immunic has spent the majority of its research and development resources on IMU-838, the Company's lead development program for clinical trials in RRMS, UC, COVID-19, and PSC. Research and development expenses consist of expenses incurred in research and development activities, which include clinical trials, contract research services, certain milestone payments, salaries and related employee benefits, allocated facility costs and other outsourced services. Research and development expenses are charged to operations as incurred. The Company enters into agreements with contract research organizations (“CROs”) to provide clinical trial services for individual studies and projects by executing individual work orders governed by a Master Service Arrangement (“MSA”). The MSAs and associated work orders provide for regular recurrent payments and payments upon the completion of certain milestones. The Company regularly assesses the timing of payments against actual costs incurred to ensure a proper accrual of related expenses in the appropriate accounting period. |
Collaboration Arrangements | Collaboration Arrangements Certain collaboration and license agreements may include payments to or from the Company of one or more of the following: non-refundable or partially refundable upfront or license fees; development, regulatory and commercial milestone payments; payment for manufacturing supply services; partial or complete reimbursement of research and development costs; and royalties on net sales of licensed products. The Company assesses whether such contracts are within the scope of Financial Accounting Standards Board (FASB) Accounting Standards Update (“ASU”) 2014-09 “ Revenue from Contracts with Customers ” and ASU No. 2018-18, “ Collaborative Arrangements”, ("ASU 2018-18"). ASU 2018-18, clarifies that certain elements of collaborative arrangements could qualify as transactions with customers in the scope of ASC 606. In October 2018, the Company entered into an option and license agreement (the "Daiichi Sankyo Agreement") with Daiichi Sankyo Co., Ltd. ("Daiichi Sankyo") which granted the Company the right to license a group of compounds, designated by the Company as IMU-856, as a potential new oral treatment option for diseases such as inflammatory bowel disease, irritable bowel syndrome with diarrhea, immune checkpoint inhibitor induced colitis and other barrier function associated diseases. During the option period, the Company performed agreed upon research and development activities for which it was reimbursed by Daiichi Sankyo up to a maximum agreed-upon limit. Such reimbursement was recorded as other income. There are no more research and development reimbursements expected under this agreement. |
General and Administrative Expenses | General and Administrative Expenses General and administrative expenses consist primarily of salaries and related costs for personnel in executive, finance, business development and other support functions. Other general and administrative expenses include, but are not limited to, stock-based compensation, insurance costs, professional fees for legal, accounting and tax services, consulting, related facility costs and travel. |
Stock-Based Compensation | Stock-Based Compensation The Company measures the cost of employee and non-employee services received in exchange for equity awards based on the grant-date fair value of the award recognized generally as an expense (i) on a straight-line basis over the requisite service period for those awards whose vesting is based upon a service condition, and (ii) on an accelerated method for awards whose vesting is based upon a performance condition, but only to the extent it is probable that the performance condition will be met. Stock-based compensation is (i) estimated at the date of grant based on the award’s fair value for equity classified awards and (ii) final measurement date for liability classified awards. Forfeitures are recorded in the period in which they occur. The Company estimates the fair value of stock options using the Black-Scholes-Merton option-pricing model ("BSM"), which requires the use of estimates and subjective assumptions, including the risk-free interest rate, the fair value of the underlying common stock, the expected dividend yield of the Company’s common stock, the expected volatility of the price of the Company’s common stock, and the expected term of the option. These estimates involve inherent uncertainties and the application of management’s judgment. If factors change and different assumptions are used, the Company’s stock-based compensation expense could be materially different in the future. |
Leases | Leases The Company leases office space and office equipment. The underlying lease agreements have lease terms of less than 12 months and up to 60 months. Leases with terms of 12 months or less at inception are not included in the operating lease right of use asset and operating lease liability. |
Comprehensive Income (Loss) | Comprehensive Income (Loss) Comprehensive income (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. Accumulated other comprehensive income (loss) has been reflected as a separate component of stockholders’ equity in the accompanying Consolidated Balance Sheets and consists of foreign currency translation adjustments (net of tax). |
Income Taxes | Income Taxes The Company is subject to corporate income tax laws and regulations in the U.S., Germany and Australia. Tax regulations within each jurisdiction are subject to the interpretation of the related tax laws and regulations and require significant judgment in their application. The Company utilizes the asset and liability method of accounting for income taxes which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the consolidated financial statements. Deferred income tax assets and liabilities are determined based on the differences between the financial statement and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of changes in tax rates on deferred tax assets and liabilities is recognized in operations in the period that includes the enactment date. Deferred taxes are reduced by a valuation allowance when, in the opinion of management, it is more likely than not some portion or the entire deferred tax asset will not be realized. As of September 30, 2021 and 2020, respectively, the Company maintained a full valuation allowance against the balance of deferred tax assets. It is the Company’s policy to provide for uncertain tax positions and the related interest and penalties based upon management’s assessment of whether a tax benefit is more likely than not to be sustained upon examination by tax authorities. The Company recognizes interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense. The Company is subject to U.S. federal, New York, California, Texas, German and Australian income taxes. The Company is subject to U.S. federal or state income tax examination by tax authorities for tax returns filed for the years 2003 and forward due to the carryforward of NOLs. Tax years 2016 through 2020 are subject to audit by German and Australian tax authorities. The Company is not currently under examination by any tax jurisdictions. |
Net Loss Per Share | Net Loss Per Share Basic net loss per share attributable to common stockholders is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share attributable to common stockholders is computed by dividing the net loss by the weighted-average number of common shares and, if dilutive, common stock equivalents outstanding for the period determined using the treasury-stock method. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Company’s net loss position. |
Recently Issued and/or Adopted Accounting Standards | Recently Issued and/or Adopted Accounting Standards There are no recently issued accounting standards that would have a significant impact on the company's consolidated financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Schedule of Potentially Dilutive Securities Not Included in Calculation of Diluted Net Loss per Share | Potentially dilutive securities, not included in the calculation of diluted net loss per share attributable to common stockholders because to do so would be anti-dilutive, are as follows: As of September 30, 2021 2020 Options to purchase common stock 2,045,960 969,822 |
Balance Sheet Details (Tables)
Balance Sheet Details (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Other Current Assets and Prepaid Expenses | Other Current Assets and Prepaid Expenses consist of (in thousands): September 30, 2021 December 31, 2020 Prepaid clinical and related costs $ 7,872 $ 3,416 VAT receivable 310 295 Australian research and development tax incentive 2,594 1,348 Other 1,275 1,234 Total $ 12,051 $ 6,293 |
Schedule of Accounts Payable and Accrued Expenses | Accounts Payable consist of (in thousands): September 30, 2021 December 31, 2020 Clinical costs $ 2,867 $ 3,408 Legal and audit costs 101 139 Other 273 153 Total $ 3,241 $ 3,700 Accrued expenses consist of (in thousands): September 30, 2021 December 31, 2020 Accrued clinical and related costs $ 6,012 $ 3,301 Accrued legal and audit costs 67 114 Accrued compensation 528 658 Accrued other 164 245 Total $ 6,771 $ 4,318 |
Schedule of Other Current Liabilities | Other Current Liabilities consist of (in thousands): September 30, 2021 December 31, 2020 Lease liabilities $ 406 $ 297 Other 173 82 Total 579 379 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Maturities of Operating Lease Obligation | Maturities of the operating lease obligation are as follows as of September 30, 2021 (in thousands): 2021 115 2022 461 2023 312 2024 238 2025 119 Total 1,245 Interest 105 PV of obligation 1,140 |
Fair Value (Tables)
Fair Value (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Schedule of Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis | The following fair value hierarchy tables present information about each major category of the Company’s financial assets and liabilities measured at fair value on a recurring basis (in thousands): Fair Value Measurement at September 30, 2021 Fair Value Level 1 Level 2 Level 3 Assets Money market funds $ 72,626 $ 72,626 $ — $ — Total assets at fair value $ 72,626 $ 72,626 $ — $ — Fair Value Measurement at Fair Value Measurement at December 31, 2020 Fair Value Level 1 Level 2 Level 3 Assets Money market funds $ 39,615 $ 39,615 $ — $ — Total assets $ 39,615 $ 39,615 $ — $ — |
Common Stock (Tables)
Common Stock (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Equity [Abstract] | |
Shares Reserved for Future Issuance | Shares reserved for future issuance at September 30, 2021 are as follows: Number of Common stock reserved for issuance for: 2021 Employee stock Purchase Plan 200,000 Outstanding stock options 2,045,960 Common stock options available for future grant: 2014 Equity Incentive Plan 43,311 2017 Inducement Equity Incentive Plan 46,250 2019 Omnibus Equity Incentive Plan 794,090 Total common shares reserved for future issuance 3,129,611 |
Stock-Based Compensation Plans
Stock-Based Compensation Plans (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Summary of Stock Option Activity | The following table summarizes stock option activity for the nine months ended September 30, 2021 and 2020, respectively, for the 2019 Plan: Options Weighted- Weighted- Aggregate Outstanding as of January 1, 2021 1,117,160 $ 12.96 Granted 1,033,809 $ 14.95 Exercised — $ — — Forfeited or expired (105,009) $ 14.32 Outstanding as of September 30, 2021 2,045,960 $ 13.90 8.91 $ 74,460 Options vested and expected to vest as of September 30, 2021 2,045,960 $ 13.90 8.91 $ 74,460 Options exercisable as of September 30, 2021 665,168 $ 13.39 8.33 $ 43,121 Options Weighted- Weighted- Aggregate Outstanding as of January 1, 2020 456,645 $ 12.57 Granted 597,068 $ 12.24 Exercised — $ — Forfeited or expired (83,891) $ 13.32 Outstanding as of September 30, 2020 969,822 $ 12.31 9.41 $ 6,075,771 Options vested and expected to vest as of September 30, 2020 969,822 $ 12.31 9.41 $ 6,075,771 Options exercisable as of September 30, 2020 167,515 $ 12.51 8.90 $ 1,015,048 |
Schedule of Valuation Assumptions Used | The following are the underlying assumptions used in the Black-Scholes option pricing model to determine the fair value of stock options granted to employees and to non-employees under this stock plan: Nine Months Ended September 30, 2021 2020 Risk-free interest rate 0.88% 0.43% Expected dividend yield 0% 0% Expected volatility 92.4% 87.1% Expected term of options (years) 5.95 5.93 |
Schedule of Stock-based Compensation Expense for Stock Awards Recognized | Total stock-based compensation expense for all stock awards recognized in the accompanying unaudited condensed consolidated statements of operations is as follows: Three Months Nine Months 2021 2020 2021 2020 Research and development $ 456,000 $ 254,000 $ 1,279,000 $ 450,000 General and administrative 941,000 453,000 3,204,000 979,000 Total $ 1,397,000 $ 707,000 $ 4,483,000 $ 1,429,000 |
Description of Business and B_2
Description of Business and Basis of Financial Statements (Details) $ in Thousands | 9 Months Ended | 30 Months Ended | |
Sep. 30, 2021USD ($)employeedevelopmentProgram | Sep. 30, 2021USD ($)employee | Dec. 31, 2020USD ($) | |
Accounting Policies [Abstract] | |||
Number of employees | employee | 52 | 52 | |
Number of development programs | developmentProgram | 3 | ||
Accumulated deficit | $ 175,688 | $ 175,688 | $ 103,928 |
Proceeds from issuance of private placement | 258,800 | ||
Cash and cash equivalents | $ 110,444 | $ 110,444 | $ 127,452 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Details) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021USD ($)leasefinancialInstitution | Sep. 30, 2020USD ($) | Sep. 30, 2021USD ($)leasefinancialInstitution | Sep. 30, 2020USD ($) | |
Property, Plant and Equipment [Line Items] | ||||
Number of financial institutions used for cash deposits | financialInstitution | 2 | 2 | ||
Depreciation expense | $ 16,000 | $ 43,000 | $ 45,000 | $ 63,000 |
Impairment losses | $ 0 | $ 0 | $ 0 | $ 0 |
Number of existing leases | lease | 2 | 2 | ||
Minimum | ||||
Property, Plant and Equipment [Line Items] | ||||
Estimated useful life | 3 years | |||
Lease term | 12 months | 12 months | ||
Maximum | ||||
Property, Plant and Equipment [Line Items] | ||||
Estimated useful life | 13 years | |||
Lease term | 60 months | 60 months |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Potentially Dilutive Securities Not Included in Calculation of Diluted Net Loss per Share (Details) - shares | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Options to purchase common stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Options to purchase common stock (shares) | 2,045,960 | 969,822 |
Balance Sheet Details - Schedul
Balance Sheet Details - Schedule of Other Current Assets and Prepaid Expenses (Detail) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Prepaid clinical and related costs | $ 7,872 | $ 3,416 |
VAT receivable | 310 | 295 |
Australian research and development tax incentive | 2,594 | 1,348 |
Other | 1,275 | 1,234 |
Total | $ 12,051 | $ 6,293 |
Balance Sheet Details - Sched_2
Balance Sheet Details - Schedule of Accounts Payable (Detail) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Clinical costs | $ 2,867 | $ 3,408 |
Legal and audit costs | 101 | 139 |
Other | 273 | 153 |
Total | $ 3,241 | $ 3,700 |
Balance Sheet Details - Sched_3
Balance Sheet Details - Schedule of Accrued Expenses (Detail) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Accrued clinical and related costs | $ 6,012 | $ 3,301 |
Accrued legal and audit costs | 67 | 114 |
Accrued compensation | 528 | 658 |
Accrued other | 164 | 245 |
Total | $ 6,771 | $ 4,318 |
Balance Sheet Details - Sched_4
Balance Sheet Details - Schedule of Other Current Liabilities (Detail) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Lease liabilities | $ 406 | $ 297 |
Other | 173 | 82 |
Total | $ 579 | $ 379 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Mar. 31, 2021 | May 31, 2016 | Sep. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | Apr. 07, 2020 | Apr. 12, 2019 |
Loss Contingencies [Line Items] | |||||||||||
Incremental borrowing rate on operating leases | 6.00% | 6.00% | |||||||||
Operating and variable lease costs | $ 133 | $ 108 | $ 372 | $ 267 | |||||||
Contractual obligation | $ 2,200 | $ 2,200 | |||||||||
Asset purchase agreement, royalties as percent of aggregated net sales | 4.40% | ||||||||||
Common stock, shares issued (in shares) | 26,249,439 | 26,249,439 | 21,168,240 | 120,070 | |||||||
Common stock issued | $ 3 | $ 3 | $ 2 | $ 1,500 | |||||||
4SC Royalty Settlement (see Note 4) | $ 0 | $ 0 | $ 17,250 | $ 0 | |||||||
Grafelfing, Germany | |||||||||||
Loss Contingencies [Line Items] | |||||||||||
Lease term | 5 years | ||||||||||
Additions to right-of-use assets | $ 435 | $ 427 | |||||||||
New York City | |||||||||||
Loss Contingencies [Line Items] | |||||||||||
Rent holiday period | 6 months | ||||||||||
Immunic AG | |||||||||||
Loss Contingencies [Line Items] | |||||||||||
Asset purchase agreement, royalties as percent of aggregated net sales | 4.40% | ||||||||||
4SC Royalty Settlement (see Note 4) | $ 17,250 | ||||||||||
Royalty settlement agreement, cash payment, percent | 50.00% | 50.00% | 50.00% | ||||||||
Royalty settlement agreement, shares payment, percent | 50.00% | 50.00% | 50.00% |
Commitments and Contingencies_2
Commitments and Contingencies - Maturities of Operating Lease Obligation (Details) $ in Thousands | Sep. 30, 2021USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2021 | $ 115 |
2022 | 461 |
2023 | 312 |
2024 | 238 |
2025 | 119 |
Total | 1,245 |
Interest | 105 |
PV of obligation | $ 1,140 |
Fair Value - Schedule of Financ
Fair Value - Schedule of Financial Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - Fair Value, Measurements, Recurring - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Assets | ||
Total assets at fair value | $ 72,626 | $ 39,615 |
Money market funds | ||
Assets | ||
Total assets at fair value | 72,626 | 39,615 |
Level 1 | ||
Assets | ||
Total assets at fair value | 72,626 | 39,615 |
Level 1 | Money market funds | ||
Assets | ||
Total assets at fair value | 72,626 | 39,615 |
Level 2 | ||
Assets | ||
Total assets at fair value | 0 | 0 |
Level 2 | Money market funds | ||
Assets | ||
Total assets at fair value | 0 | 0 |
Level 3 | ||
Assets | ||
Total assets at fair value | 0 | 0 |
Level 3 | Money market funds | ||
Assets | ||
Total assets at fair value | $ 0 | $ 0 |
Common Stock - Shelf Registrati
Common Stock - Shelf Registration Statement (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||||||
Mar. 31, 2021 | Jun. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | Nov. 30, 2020 | Jul. 31, 2019 | May 31, 2018 | |
Class of Stock [Line Items] | |||||||||
Maximum aggregate offering price of common stock, preferred stock, warrants, debt securities, and/or units | $ 200,000,000 | ||||||||
Maximum common stock shares authorized (in shares) | 250,000,000 | ||||||||
Commission, percent of gross proceeds from sale of common stock | 3.00% | ||||||||
Issuance of common stock | $ 8,625,000 | $ 568,000 | |||||||
July 2019 Equity Issuances | |||||||||
Class of Stock [Line Items] | |||||||||
Maximum aggregate offering price of common stock, preferred stock, warrants, debt securities, and/or units | $ 40,000,000 | ||||||||
December 2020 Equity Issuances | |||||||||
Class of Stock [Line Items] | |||||||||
Maximum aggregate offering price of common stock, preferred stock, warrants, debt securities, and/or units | $ 50,000,000 | ||||||||
Maximum aggregate offering price of common stock under ATM agreement | $ 50,000,000 | ||||||||
At the Market Sales Agreement | |||||||||
Class of Stock [Line Items] | |||||||||
Issuance of common stock | $ 2,246,000 | $ 2,900,000 | |||||||
Issuance of common stock (in shares) | 283,828 | ||||||||
Issuance of stock (in USD per share) | $ 10.31 | ||||||||
Proceeds from issuance of common stock | $ 2,800,000 | ||||||||
Underwriter commissions | 87,766 | ||||||||
Estimated offering expenses | $ 23,996 |
Common Stock - Public Equity Of
Common Stock - Public Equity Offering (Details) - USD ($) $ / shares in Units, $ in Thousands | Jul. 19, 2021 | Jul. 15, 2021 | Aug. 07, 2020 | Aug. 04, 2020 | Jun. 12, 2020 | Jun. 10, 2020 | Apr. 23, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 |
Class of Stock [Line Items] | ||||||||||
Common stock, par value (in USD per share) | $ 0.0001 | $ 0.0001 | ||||||||
July 2021 Public Equity Offering | ||||||||||
Class of Stock [Line Items] | ||||||||||
Shares issued in private placement transaction (in shares) | 4,500,000 | |||||||||
Common stock, par value (in USD per share) | $ 0.0001 | |||||||||
Sale of stock, price per share (in dollars per share) | $ 10 | |||||||||
Proceeds from sale of stock | $ 42,000 | |||||||||
Proceeds from issuance of common stock | $ 42,020 | $ 0 | ||||||||
August 2020 Equity Issuances | ||||||||||
Class of Stock [Line Items] | ||||||||||
Shares issued in private placement transaction (in shares) | 5,000,000 | |||||||||
Sale of stock, price per share (in dollars per share) | $ 18 | |||||||||
Proceeds from issuance of common stock | $ 96,500 | |||||||||
Exercisable period on additional issuance of common stock | 30 days | |||||||||
Number of additional shares authorized (in shares) | 750,000 | |||||||||
Placement Agency Agreement | ||||||||||
Class of Stock [Line Items] | ||||||||||
Shares issued in private placement transaction (in shares) | 2,175,000 | |||||||||
Cash fee, percent of gross proceeds | 6.50% | |||||||||
Securities Purchase Agreement | ||||||||||
Class of Stock [Line Items] | ||||||||||
Shares issued in private placement transaction (in shares) | 2,175,000 | 1,764,706 | ||||||||
Sale of stock, price per share (in dollars per share) | $ 11.40 | $ 8.50 | ||||||||
Proceeds from issuance of common stock | $ 25,000 | $ 15,000 | ||||||||
Period in which company cannot issue additional common stock | 75 days | |||||||||
June 2020 Offering | ||||||||||
Class of Stock [Line Items] | ||||||||||
Proceeds from issuance of common stock | $ 23,000 |
Common Stock - Registered Direc
Common Stock - Registered Direct Offering (Details) - USD ($) $ / shares in Units, $ in Millions | Jun. 10, 2020 | Apr. 27, 2020 | Apr. 23, 2020 |
Letter Agreement | |||
Class of Stock [Line Items] | |||
Cash fee, percent of gross proceeds | 6.50% | ||
Securities Purchase Agreement | |||
Class of Stock [Line Items] | |||
Shares issued in private placement transaction (in shares) | 2,175,000 | 1,764,706 | |
Sale of stock, price per share (in dollars per share) | $ 11.40 | $ 8.50 | |
Proceeds from issuance of common stock | $ 25 | $ 15 | |
Period in which company cannot issue additional common stock | 75 days | ||
The Offering | |||
Class of Stock [Line Items] | |||
Proceeds from issuance of common stock | $ 13.9 |
Common Stock - Common Stock (De
Common Stock - Common Stock (Details) - $ / shares | 9 Months Ended | |
Sep. 30, 2021 | Dec. 31, 2020 | |
Equity [Abstract] | ||
Common stock, shares authorized (in shares) | 130,000,000 | 130,000,000 |
Common stock, par value (in USD per share) | $ 0.0001 | $ 0.0001 |
Common stock, cash dividends declared (in USD per share) | 0 | |
Common stock, cash dividends paid (in USD per share) | $ 0 |
Common Stock - Preferred Stock
Common Stock - Preferred Stock (Details) - $ / shares | Sep. 30, 2021 | Dec. 31, 2020 |
Equity [Abstract] | ||
Preferred stock, shares authorized (in shares) | 20,000,000 | 20,000,000 |
Preferred stock, par value (in USD per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common Stock - Shares Reserved
Common Stock - Shares Reserved for Future Issuance (Details) | Sep. 30, 2021shares |
Class of Stock [Line Items] | |
Total common shares reserved for future issuance (in shares) | 3,129,611 |
Outstanding stock options | |
Class of Stock [Line Items] | |
Total common shares reserved for future issuance (in shares) | 2,045,960 |
2021 Employee stock Purchase Plan | Outstanding stock options | |
Class of Stock [Line Items] | |
Total common shares reserved for future issuance (in shares) | 200,000 |
2014 Equity Incentive Plan | Common stock options available for future grant: | |
Class of Stock [Line Items] | |
Total common shares reserved for future issuance (in shares) | 43,311 |
2017 Inducement Equity Incentive Plan | Common stock options available for future grant: | |
Class of Stock [Line Items] | |
Total common shares reserved for future issuance (in shares) | 46,250 |
2019 Omnibus Equity Incentive Plan | Common stock options available for future grant: | |
Class of Stock [Line Items] | |
Total common shares reserved for future issuance (in shares) | 794,090 |
Stock-Based Compensation Plan_2
Stock-Based Compensation Plans - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 21 Months Ended | ||
Jul. 31, 2019 | Sep. 30, 2021 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Expected dividend yield | 0.00% | |||||
Total unrecognized compensation expense | $ 13,000 | $ 13,000 | $ 13,000 | |||
Period over which compensation cost will be recognized, in years | 2 years 11 months 4 days | |||||
2021 Employee stock Purchase Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Shares available for grant (in shares) | 200,000 | 200,000 | 200,000 | |||
Share-based compensation expense | $ 18 | $ 18 | ||||
2019 Omnibus Equity Incentive Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Shares available for grant (in shares) | 1,500,000 | |||||
Expected term of options (years) | 5 years 11 months 12 days | 5 years 11 months 4 days | ||||
Expected dividend yield | 0.00% | 0.00% | ||||
Options granted in period, weighted-average grant date fair value (in USD per share) | $ 11.14 | $ 8.75 | ||||
2019 Omnibus Equity Incentive Plan, Evergreen Provision | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Additional shares authorized, percent | 4.00% | |||||
Additional shares authorized (in shares) | 4,900,000 | 1,340,050 | ||||
2014 Equity Incentive Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Shares available for grant (in shares) | 43,311 | 43,311 | 43,311 | |||
2017 Inducement Equity Incentive Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Shares available for grant (in shares) | 46,250 | |||||
Incentive stock options | 2019 Omnibus Equity Incentive Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting period (in years) | 4 years | |||||
Minimum | Non-statutory options | 2019 Omnibus Equity Incentive Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting period (in years) | 3 years | |||||
Maximum | 2019 Omnibus Equity Incentive Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Expected term of options (years) | 10 years | |||||
Maximum | Non-statutory options | 2019 Omnibus Equity Incentive Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting period (in years) | 4 years |
Stock-Based Compensation Plan_3
Stock-Based Compensation Plans - Summary of Stock Option Activity (Details) - 2019 Omnibus Equity Incentive Plan - Outstanding stock options - USD ($) | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Options | ||
Outstanding, beginning balance (in shares) | 1,117,160 | 456,645 |
Granted (in shares) | 1,033,809 | 597,068 |
Exercised (in shares) | 0 | 0 |
Forfeited or expired (in shares) | (105,009) | (83,891) |
Outstanding, ending balance (in shares) | 2,045,960 | 969,822 |
Options vested and expected to vest, Ending balance (in shares) | 2,045,960 | 969,822 |
Options exercisable, Ending balance (in shares) | 665,168 | 167,515 |
Weighted- Average Exercise Price | ||
Outstanding, beginning balance (usd per share) | $ 12.96 | $ 12.57 |
Granted (usd per share) | 14.95 | 12.24 |
Exercised (usd per share) | 0 | 0 |
Forfeited or expired (usd per share) | 14.32 | 13.32 |
Outstanding, ending balance (usd per share) | 13.90 | 12.31 |
Options vested and expected to vest, Weighted-Average Exercise Price, Ending balance (usd per share) | 13.90 | 12.31 |
Options exercisable, Weighted-Average Exercise Price, Ending balance (usd per share) | $ 13.39 | $ 12.51 |
Other Disclosures | ||
Outstanding, Weighted-Average Remaining Contractual Term, Ending balance | 8 years 10 months 28 days | 9 years 4 months 28 days |
Options vested and expected to vest , Weighted-Average Remaining Contractual Term, Ending balance | 8 years 10 months 28 days | 9 years 4 months 28 days |
Options exercisable, Weighted-Average Remaining Contractual Term, Ending balance | 8 years 3 months 29 days | 8 years 10 months 24 days |
Outstanding, Aggregate Intrinsic Value, Ending balance | $ 74,460 | $ 6,075,771 |
Options vested and expected to vest , Aggregate Intrinsic Value, Ending balance | 74,460 | 6,075,771 |
Options exercisable, Aggregate Intrinsic Value, Ending balance | $ 43,121 | $ 1,015,048 |
Stock-Based Compensation Plan_4
Stock-Based Compensation Plans - Ranges of Underlying Assumptions Used in BSM Option Pricing Model to Determine Fair Value of Stock Options Granted to Employees and Nonemployees (Detail) | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected dividend yield | 0.00% | |
2019 Omnibus Equity Incentive Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 0.88% | 0.43% |
Expected dividend yield | 0.00% | 0.00% |
Expected volatility | 92.40% | 87.10% |
Expected term of options (years) | 5 years 11 months 12 days | 5 years 11 months 4 days |
Stock-Based Compensation Plan_5
Stock-Based Compensation Plans - Schedule of Stock-based Compensation Expense for Stock Awards Recognized (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | $ 4,483 | $ 1,429 | ||
Employees | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | $ 1,397,000 | $ 707,000 | 4,483,000 | 1,429,000 |
Employees | Research and Development | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | 456,000 | 254,000 | 1,279,000 | 450,000 |
Employees | General and Administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | $ 941,000 | $ 453,000 | $ 3,204,000 | $ 979,000 |
EIB Loan (Details)
EIB Loan (Details) | Oct. 19, 2020EUR (€)tranche |
Debt Instrument [Line Items] | |
Number of tranches | tranche | 3 |
Line of Credit | EIB Loan | |
Debt Instrument [Line Items] | |
Term loan, maximum borrowing capacity | € | € 24,500,000 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Details) - Executive Chairman Agreement - Affiliated Entity - Duane Nash, MD, JD, MBA - USD ($) | Apr. 15, 2021 | Jun. 30, 2021 | May 14, 2021 |
Related Party Transaction [Line Items] | |||
Granted (in shares) | 90,000 | ||
Monthly base salary | $ 27,960 | $ 25,417 |