Cover Page
Cover Page - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Mar. 21, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2021 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-38473 | ||
Entity Registrant Name | Evelo Biosciences, Inc. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 46-5594527 | ||
Entity Address, Address Line One | 620 Memorial Drive | ||
Entity Address, City or Town | Cambridge | ||
Entity Address, State or Province | MA | ||
Entity Address, Postal Zip Code | 02139 | ||
City Area Code | 617 | ||
Local Phone Number | 577-0300 | ||
Title of 12(b) Security | Common Stock, par value $0.001 per share | ||
Trading Symbol | EVLO | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | false | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 413.7 | ||
Entity Common Stock, Shares Outstanding | 53,643,263 | ||
Documents Incorporated by Reference | Portions of the registrant’s definitive proxy statement for its 2022 annual meeting of stockholders, which the registrant intends to file pursuant to Regulation 14A with the Securities and Exchange Commission not later than 120 days after the registrant’s fiscal year ended December 31, 2021, are incorporated by reference into Part III of this Annual Report on Form 10-K. | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0001694665 |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2021 | |
Auditor Information [Abstract] | |
Auditor Name | Ernst & Young LLP |
Auditor Location | Boston, Massachusetts |
Auditor Firm ID | 42 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 68,441 | $ 68,857 |
Prepaid expenses and other current assets | 2,585 | 2,123 |
Total current assets | 71,026 | 70,980 |
Property and equipment, net | 6,622 | 7,478 |
Right of use asset - operating lease | 8,910 | 10,757 |
Other assets | 1,313 | 1,424 |
Total assets | 87,871 | 90,639 |
Current liabilities: | ||
Accounts payable | 1,601 | 1,442 |
Accrued expenses | 13,068 | 16,254 |
Operating lease liability, current portion | 1,951 | 1,674 |
Other current liabilities | 742 | 463 |
Total current liabilities | 17,362 | 19,833 |
Noncurrent liabilities: | ||
Long-term debt | 46,557 | 30,048 |
Operating lease liability, net of current portion | 7,785 | 9,989 |
Deferred revenue | 7,500 | 0 |
Other noncurrent liabilities | 0 | 284 |
Total liabilities | 79,204 | 60,154 |
Commitments and contingencies (Note 10) | ||
Stockholder’s equity: | ||
Preferred stock, $0.001 par value; 10,000,000 shares authorized; no shares issued and outstanding at December 31, 2021 and 2020, respectively | 0 | 0 |
Common stock, $0.001 par value; 200,000,000 shares authorized; 53,576,454 and 47,488,505 shares issued and 53,576,454 and 47,470,119 shares outstanding at December 31, 2021 and 2020, respectively | 54 | 47 |
Additional paid-in capital | 423,308 | 322,957 |
Accumulated deficit | (414,695) | (292,519) |
Total stockholders’ equity | 8,667 | 30,485 |
Total liabilities and stockholders’ equity | $ 87,871 | $ 90,639 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, issued (in shares) | 0 | 0 |
Preferred stock, outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 200,000,000 | 200,000,000 |
Common stock shares issued (in shares) | 53,576,454 | 47,488,505 |
Common stock, shares outstanding (in shares) | 53,576,454 | 47,470,119 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Operating expenses: | ||
Research and development | $ 83,643 | $ 69,616 |
General and administrative | 31,753 | 22,270 |
Total operating expenses | 115,396 | 91,886 |
Loss from operations | (115,396) | (91,886) |
Other (expense) income: | ||
Interest expense, net | (3,612) | (2,109) |
Loss on extinguishment of debt | (3,226) | 0 |
Other income, net | 486 | 738 |
Other expense, net | (6,352) | (1,371) |
Loss before income taxes | (121,748) | (93,257) |
Income tax expense | (428) | (409) |
Net loss | $ (122,176) | $ (93,666) |
Net loss per share attributable to common stockholders, basic (in dollars per share) | $ (2.31) | $ (2.37) |
Net loss per share attributable to common stockholders, diluted (in dollars per share) | $ (2.31) | $ (2.37) |
Weighted average number of common shares outstanding, basic (in shares) | 52,910,982 | 39,479,197 |
Weighted average number of common shares outstanding, diluted (in shares) | 52,910,982 | 39,479,197 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders’ Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2019 | 32,170,605 | |||
Beginning balance at Dec. 31, 2019 | $ 60,197 | $ 32 | $ 259,018 | $ (198,853) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Issuance of common stock, net (in shares) | 15,032,131 | |||
Issuance of common stock, net | 54,994 | $ 15 | 54,979 | |
Vesting of restricted common stock (in shares) | 43,267 | |||
Vesting of restricted common stock | 21 | 21 | ||
Issuance of common stock under ESPP (in shares) | 28,603 | |||
Issuance of common stock under ESPP | 92 | 92 | ||
Exercise of stock options (in shares) | 195,513 | |||
Exercise of stock options | 379 | 379 | ||
Stock-based compensation expense | 8,468 | 8,468 | ||
Net loss | (93,666) | (93,666) | ||
Ending balance (in shares) at Dec. 31, 2020 | 47,470,119 | |||
Ending balance at Dec. 31, 2020 | 30,485 | $ 47 | 322,957 | (292,519) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Issuance of common stock, net (in shares) | 5,814,734 | |||
Issuance of common stock, net | 81,751 | $ 6 | 81,745 | |
Vesting of restricted common stock (in shares) | 111,440 | |||
Issuance of common stock under ESPP (in shares) | 46,358 | |||
Issuance of common stock under ESPP | $ 237 | 237 | ||
Exercise of stock options (in shares) | 133,803 | 133,803 | ||
Exercise of stock options | $ 774 | $ 1 | 773 | |
Stock-based compensation expense | 15,846 | 15,846 | ||
Issuance of common stock warrants | 1,750 | 1,750 | ||
Net loss | (122,176) | (122,176) | ||
Ending balance (in shares) at Dec. 31, 2021 | 53,576,454 | |||
Ending balance at Dec. 31, 2021 | $ 8,667 | $ 54 | $ 423,308 | $ (414,695) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Operating activities | ||
Net loss | $ (122,176) | $ (93,666) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 15,846 | 8,468 |
Depreciation expense | 2,216 | 2,026 |
Non-cash interest expense | 255 | 374 |
Non-cash lease expense | 1,847 | 1,976 |
Loss on Extinguishment of Debt | 3,226 | 0 |
Gain on sale of fixed assets | (7) | (6) |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (622) | 1,503 |
Accounts payable | 159 | 837 |
Accrued expenses and other current liabilities | (2,758) | 7,438 |
Operating lease liabilities | (1,927) | (2,218) |
Deferred revenue | 7,500 | 0 |
Other liabilities | (284) | 205 |
Net cash used in operating activities | (96,725) | (73,063) |
Investing activities | ||
Purchases of property and equipment | (1,519) | (1,321) |
Proceeds from the sale of fixed assets | 38 | 6 |
Net cash used in investing activities | (1,481) | (1,315) |
Financing activities | ||
Proceeds from issuance of common stock, net of issuance cost | 81,751 | 54,994 |
Proceeds from the issuance of common stock under employee stock purchase plan and the exercise of stock options | 1,011 | 471 |
Proceeds from the issuance of long-term debt, net of issuance costs | 14,778 | 10,000 |
Net cash provided by financing activities | 97,540 | 65,465 |
Net increase in cash, cash equivalents and restricted cash | (666) | (8,913) |
Cash, cash equivalents and restricted cash – beginning of period | 70,420 | 79,333 |
Cash, cash equivalents and restricted cash – end of period | 69,754 | 70,420 |
Supplemental disclosure of cash flow information | ||
Cash paid for interest | 3,378 | 2,172 |
Cash paid for taxes | 25 | 20 |
Noncash investing and financing activities | ||
Deferred financing and public offering costs in accounts payable and accrued expenses | 0 | 111 |
Property and equipment additions in accounts payable and accrued expenses | 29 | 178 |
Issuance of common stock warrants | $ 1,750 | $ 0 |
Organization and Basis of Prese
Organization and Basis of Presentation | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Basis of Presentation | Organization and Basis of Presentation Evelo Biosciences, Inc. ("Evelo", "we", "our" "us" or the "Company”) is a biotechnology company which was incorporated in Delaware on May 6, 2014. We are discovering and developing a new class of orally delivered investigational medicines that are intended to act on cells in the small intestine to produce therapeutic effects throughout the body. We are advancing these investigational medicines with the aim of treating a broad range of immune mediated diseases, with an initial focus on inflammatory diseases and oncology. Our headquarters is located in Cambridge, Massachusetts. Since inception, we have devoted substantially all of our efforts to research and development and raising capital. We have not generated any product or license revenue related to our primary business purpose to date. We are subject to a number of risks similar to those of other development stage companies, including dependence on key individuals, the need to develop commercially viable products, competition from other companies, many of whom are larger and better capitalized, and the need to obtain adequate additional financing to fund the development of our products. To date, we have financed operations primarily with the proceeds from the issuance of common stock combined with proceeds from previous sales of convertible preferred stock to equity investors and debt financing. On June 3, 2019, we filed a Registration Statement on Form S-3 (File No. 333-231911) (the “2019 Shelf”) with the United States Securities and Exchange Commission (the "SEC") in relation to the registration of common stock, preferred stock, debt securities, warrants and/or units of any combination thereof in the aggregate amount of up to $200.0 million for a period of up to three years from the date of its effectiveness on June 6, 2019. We also simultaneously entered into a sales agreement (the "ATM") with Cowen and Company, LLC, as sales agent, providing for the offering, issuance and sale by us of up to an aggregate $50.0 million of our common stock from time to time in “at-the-market” offerings under the 2019 Shelf. For the year ended December 31, 2020, we sold 1,232,131 common shares under the ATM with offering prices ranging between $4.25 to $11.15 per share for gross proceeds of $6.8 million and net proceeds of $6.6 million, after deducting commission and other offering expenses payable by us. For the year ended December 31, 2021, we issued 139,734 additional shares of common stock under the ATM with offering prices ranging between $12.54 and $13.17 per share for gross proceeds of $1.8 million and net proceeds of $1.7 million, net of commission and other offering expenses. On February 2, 2021, we sold 5,175,000 shares of our common stock in an underwritten public offering at a public offering price of $15.00 per share, including the underwriters' exercise of their option to purchase 675,000 shares to cover over-allotment, generating gross proceeds of $77.6 million and net proceeds after underwriting discounts and commission of $72.7 million, after deducting underwriting discounts and commissions and other offering expenses paid by us. On January 28, 2021, we entered into a stock purchase agreement with ALJ Health Care & Life Science Company Limited ("ALJ Health Care"), pursuant to which on February 2, 2021, ALJ Health Care purchased $7.5 million of our common stock in a private placement at a purchase price of $15.00 per share, equal to the public offering price per share at which our common stock was sold to the public as referred above. The sale of such shares was not registered under the Securities Act. On August 23, 2021, we filed a Registration Statement on Form S-3 (File No. 333-259005) (the “2021 Shelf”) with the SEC in relation to the registration of common stock, preferred stock, debt securities, warrants and/or units of any combination thereof in the aggregate amount of up to $200 million for a period of up to three years from the date of its effectiveness on August 30, 2021. We have incurred operating losses since inception and expect such losses and negative operating cash flows to continue for the foreseeable future. As of December 31, 2021, we had cash and cash equivalents of $68.4 million and an accumulated deficit of $414.7 million. In accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Update (“ASU”) 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40), we evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within one year after the date that the audited consolidated financial statements are issued. The transition to profitability is dependent upon the successful development, approval, and commercialization of our products and product candidates and the achievement of a level of revenue adequate to support our cost structure. Based on our current operating plan, we believe that our cash and cash equivalents at December 31, 2021, will not be sufficient to fund operations and capital expenditures for at least the twelve months following the filing of this Annual Report on Form 10-K, and we will need to obtain additional funding. We intend to obtain additional funding through available financing sources which may include additional public offerings of common stock, private financing of debt or equity, and / or the pursuit of strategic partnerships, licensing arrangements or collaborations. Our ability to fund operations is based on estimates that are subject to risks and uncertainties. If actual results are different from our estimates, we may need to seek additional funding sooner than would otherwise be expected. There can be no assurance that we will be able to obtain additional funding on acceptable terms, if at all. If we are unable to obtain sufficient funding, we will be required to delay, scale back or discontinue our development efforts, limit activities and / or reduce research and development costs, which would adversely affect our business prospects. Due to the uncertainty in securing additional funding, and the insufficient amount of cash and cash equivalent resources at December 31, 2021, we have concluded that substantial doubt exists with respect to our ability to continue as a going concern within one year after the date that the audited consolidated financial statements are issued. The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty. |
Significant Accounting Policies
Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | Significant Accounting Policies Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the accrual of research and development expenses and the valuation of stock-based awards. We base our estimates on historical experience and other market-specific or other relevant assumptions that we believe to be reasonable under the circumstances. Actual results could differ from those estimates. Principles of Consolidation The consolidated financial statements include the accounts of our business and our wholly owned, controlled subsidiaries. All intercompany transactions and balances have been eliminated in consolidation. Subsequent Event Considerations We consider events or transactions that occur after the balance sheet date but prior to the issuance of the consolidated financial statements to provide additional evidence for certain estimates or to identify matters that require additional disclosure. Subsequent events have been evaluated as required. We have evaluated all subsequent events and determined that there are no material recognized or unrecognized subsequent events requiring disclosure. Emerging Growth Company Status We are an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012 (the "JOBS Act"), and we may take advantage of reduced reporting requirements that are otherwise applicable to public companies. We may take advantage of these exemptions until we no longer are an emerging growth company. Section 107 of the JOBS Act provides that an emerging growth company can take advantage of the extended transition period afforded by the JOBS Act for the implementation of new or revised accounting standards. We have elected to use the extended transition period for complying with new or revised accounting standards and, as a result of this election, our consolidated financial statements may not be comparable to companies that comply with public company effective dates. We may take advantage of these exemptions up until the last day of the fiscal year following the fifth anniversary of our IPO or such earlier time that we no longer are an emerging growth company. We would cease to be an emerging growth company if we have more than $1.07 billion in annual revenue, have more than $700.0 million in market value of our stock held by non-affiliates (and have been a public company for at least 12 months and have filed one annual report on Form 10-K), or have issued more than $1.0 billion of non-convertible debt securities over a three-year period. Concentrations of Credit Risk and Off-Balance Sheet Risk Financial instruments that potentially expose us to concentrations of credit risk primarily consist of cash and cash equivalents. We place our cash and cash equivalents in primarily two custodian accounts at accredited financial institutions. Such deposits have and will continue to exceed federally insured limits. As of December 31, 2021 and 2020, we have no off-balance sheet risk such as foreign exchange contracts, option contracts, or other foreign hedging arrangements. We are subject to a number of risks similar to other early-stage biopharmaceutical companies including, but not limited to, the need to obtain adequate additional funding, possible failure of current or future preclinical testing or clinical trials, our reliance on third parties to conduct our clinical trials, the need to obtain regulatory and marketing approvals for our product candidates, competitors developing new technological innovations, the need to successfully commercialize and gain market acceptance of our product candidates, our right to develop and commercialize our product candidates pursuant to the terms and conditions of the licenses granted to us, protection of proprietary technology, the ability to make milestone, royalty or other payments due under any license or collaboration agreements, and the need to secure and maintain adequate manufacturing arrangements. If we do not successfully commercialize, license or partner any of our product candidates, we will be unable to generate product revenue or achieve profitability. Comprehensive Loss Comprehensive loss consists of net loss and changes in equity during a period from transactions and other equity and circumstances generated from non-owner sources. Our net loss equals comprehensive loss for all periods presented. Cash, Cash Equivalents and Restricted Cash Cash equivalents are comprised of highly liquid investments that are readily convertible into cash with original maturities of three months or less. Cash and cash equivalents include cash held in banks and amounts held in money market funds. Our restricted cash consists of deposit requirements in connection with the lease for our headquarters office and laboratory premises and related to our credit card facility. We did not have a current restricted cash balance at December 31, 2021. As of December 31, 2020, we had $0.3 million in current restricted cash balance recorded within prepaid expenses. As of December 31, 2021 and 2020, we had noncurrent restricted cash of $1.3 million, which was included within other assets in the consolidated balance sheets. The following reconciles cash, cash equivalents and restricted cash as of December 31, 2021 and 2020, as presented on the consolidated statements of cash flows, to our related consolidated balance sheet accounts (in thousands): December 31, 2021 2020 Cash and cash equivalents: Cash $ 1,452 $ 4,487 Money market funds 66,989 64,370 Total cash and cash equivalents 68,441 68,857 Restricted cash 1,313 1,563 Cash, cash equivalents and restricted cash $ 69,754 $ 70,420 Fair Value of Financial Instruments ASC 820, Fair Value Measurement (“ASC 820”), establishes a fair value hierarchy for instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and our own assumptions (unobservable inputs). Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of us. Unobservable inputs are inputs that reflect our assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances. ASC 820 identifies fair value as the exchange price, or exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As a basis for considering market participant assumptions in fair value measurements, ASC 820 establishes a three-tier fair value hierarchy that distinguishes between the following: • Level 1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities; • Level 2 inputs are inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly; and • Level 3 inputs are unobservable inputs that reflect our own assumptions about the assumptions market participants would use in pricing the asset or liability. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment we exercise in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. An entity may choose to measure many financial instruments and certain other items at fair value at specified election dates. Subsequent unrealized gains and losses on items for which the fair value option has been elected will be reported in earnings. We did not elect to measure any additional financial instruments or other items at fair value. Property and Equipment Property and equipment consists of computer hardware and software, furniture and fixtures, office equipment, research and lab equipment, and leasehold improvement recorded at cost. Lab equipment used in research and development activities is only capitalized when it has an alternative future use. These amounts are depreciated using the straight-line method over the estimated useful lives of the assets. Purchased assets that are not yet in service are recorded to construction-in-process and no depreciation expense is recorded. Once they are placed in service they are reclassified to the appropriate asset class. A summary of the estimated useful lives is as follows: Classification Estimated Useful Life Computer hardware 3 - 5 years Computer software 3 years Furniture and fixtures 7 years Research and lab equipment (used/new) 3 - 5 years Leasehold improvements Lesser of asset life or remaining life of lease Repairs and maintenance costs are expensed as incurred. Impairment of Long-Lived Assets We periodically evaluate property and equipment for impairment whenever events or changes in circumstances indicate that a potential impairment may have occurred. If such events or changes in circumstances arise, we compare the carrying amount of the long-lived assets to the estimated future undiscounted cash flows expected to be generated by the long-lived assets. If the estimated aggregate undiscounted cash flows are less than the carrying amount of the long-lived assets, an impairment charge, calculated as the amount by which the carrying amount of the assets exceeds the fair value of the assets, is recorded. The fair value of the long-lived assets is determined based on the estimated discounted cash flows expected to be generated from the long-lived assets. We have not recorded any material impairment charges during the years presented. Income Taxes We record deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the financial statement carrying amounts and the tax bases of assets and liabilities and for loss and credit carryforwards using enacted tax rates expected to be in effect in the years in which the differences reverse. A valuation allowance is provided to reduce the net deferred tax assets to the amount that will more likely than not be realized. We determine whether it is more likely than not that a tax position will be sustained upon examination. If it is not more likely than not that a position will be sustained, none of the benefit attributable to the position is recognized. The tax benefit to be recognized for any tax position that meets the more-likely-than-not recognition threshold is calculated as the largest amount that is more than 50% likely of being realized upon resolution of the contingency. We account for interest and penalties related to uncertain tax positions as part of our provision for income taxes. Collaboration Agreements We analyze our collaboration arrangements to assess whether they are within the scope of ASC 808, Collaborative Arrangements ("ASC 808") to determine whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards that are dependent on the commercial success of such activities. To the extent the arrangement is within the scope of ASC 808, we assess whether aspects of the arrangement between us and our collaboration partner are within the scope of other accounting literature, including ASC 606. If it is concluded that some or all aspects of the arrangement represent a transaction with a customer, we will account for those aspects of the arrangement within the scope of ASC 606. ASC 808 provides guidance for the presentation and disclosure of transactions in collaborative arrangements, but it does not provide recognition or measurement guidance. Therefore, if we conclude a counterparty to a transaction is not a customer or otherwise not within the scope of ASC 606, we consider the guidance in other accounting literature, including the guidance in ASC 606, as applicable or by analogy to account for such transaction. The classification of transactions under our arrangements is determined based on the nature and contractual terms of the arrangement along with the nature of the operations of the participants. Revenue Recognition To determine the appropriate amount of revenue to be recognized for arrangements that we determine are within the scope of ASC 606, we perform the following steps: (i) identify the contract(s) with the customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) each performance obligation is satisfied. ASC 606 requires significant judgment and estimates and results in changes to, but not limited to: (i) the determination of the transaction price, including estimates of variable consideration, (ii) the allocation of the transaction price, including the determination of estimated selling price, and (iii) the pattern of recognition, including the application of proportional performance as a measure of progress on service-related promises and application of point-in-time recognition for supply-related promises. The promised good or services in our arrangement may consist of license rights to our intellectual property or research and development services. We also may have optional additional items in contracts, which are considered marketing offers and are accounted for as separate contracts with the customer if such option is elected by the customer, unless the option provides a material right which would not be provided without entering into the contract. Performance obligations are promised goods or services in a contract to transfer a distinct good or service to the customer. Promised goods or services are considered distinct when (i) the customer can benefit from the good or service on its own or together with other readily available resources, or (ii) the promised good or service is separately identifiable from other promises in the contract. In assessing whether promised goods or services are distinct, we consider factors such as the stage of development of the underlying intellectual property, the capabilities of the customer to develop the intellectual property on their own or whether the required expertise is readily available. The transaction price may be comprised of fixed payments, often an upfront payment due at contract inception, or other types of variable consideration in the form of payments for our services and materials and milestone payments due upon the achievement of specified events. Other payments we could be entitled to include tiered royalties earned when customers recognize net sales of licensed products. We consider the existence of any significant financing component within its arrangements to the extent there is a significant difference between the timing of payment and the transfer of control of the performance obligations. In making that determination, we consider whether substantive business purposes exist to support the payment structure other than to provide a significant benefit of financing. We measure the transaction price based on the amount of consideration to which it expects to be entitled in exchange for transferring the promised goods and/or services to the customer. We utilize either the expected value method or the most likely amount method to estimate the amount of variable consideration, depending on which method is expected to better predict the amount of consideration to which we will be entitled. Amounts of variable consideration are included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. With respect to arrangements that include payments for a development or regulatory milestone payment, we evaluate whether the associated event is considered probable of achievement and estimates the amount to be included in the transaction price using the most likely amount method. Milestone payments that are not within our or the licensee’s control, such as those dependent upon receipt of regulatory approval, are not considered to be probable of achievement until the triggering event occurs. At the end of each reporting period, we re-evaluate the probability of achievement of each milestone and any related constraint, and if necessary, adjusts our estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenue and net loss in the period of adjustment. For arrangements that include sales-based royalties, including milestone payments based upon the achievement of a certain level of product sales, wherein the license is deemed to be the sole or predominant item to which the payments relate, we recognize revenue upon the later of: (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the payment has been allocated has been satisfied (or partially satisfied). Consideration that would be received for optional goods and/or services is excluded from the transaction price at contract inception. For arrangements with more than one performance obligation, we generally allocate the transaction price to each performance obligation based on a relative standalone selling price basis. We develop assumptions that require judgment to determine the standalone selling price for each performance obligation in consideration of applicable market conditions and relevant entity-specific factors, including factors that were contemplated in negotiating the agreement with the customer and estimated research and development costs. However, in certain instances, we may allocate variable consideration entirely to one or more performance obligation if the terms of the variable consideration relate to the satisfaction of the respective performance obligation and the amount allocated is consistent with the amount we would expect to receive for the satisfaction of the respective performance obligation. We recognize revenue based on the amount of the transaction price that is allocated to each respective performance obligation when or as the performance obligation is satisfied by transferring a promised good or service to the customer. For performance obligations that are satisfied at a point in time, we recognize revenue when control of the goods and/or services is transferred to the customer. For performance obligations that are satisfied over time, we recognize revenue by measuring the progress toward complete satisfaction of the performance obligation using a single method of measuring progress which depicts the performance in transferring control of the associated goods and/or services to the customer. With respect to arrangements containing a license to our intellectual property that is determined to be distinct from the other performance obligations identified in the arrangement, we recognize revenue from amounts allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, we utilize judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue. Significant management judgment is required in determining the level of effort required under an arrangement and the period over which we are expected to complete our performance obligations under an arrangement. We evaluate the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenue and net loss in the period of adjustment. Contract Liabilities We record a contract liability, classified as deferred revenue on our consolidated balance sheet, when it has received payment but has not yet satisfied the related performance obligations. In the event of an early termination of a contract with a customer, any contract liabilities would be recognized in the period in which all our obligations under the agreement have been fulfilled. Research and Development Costs Research and development costs are expensed in the period incurred. Research and development expenses consist of both internal and external costs such as payroll, consulting, and manufacturing costs associated with the development of our product candidates. Costs for certain development activities, such as clinical trials and manufacturing development activities, are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, and information provided to us by our vendors on their actual costs incurred or level of effort expended. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected on the audited consolidated balance sheets as prepaid or accrued research and development expenses. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are deferred and capitalized. The capitalized amounts are expensed as the related goods are delivered or the services are performed. We have and may continue to acquire the rights to develop and commercialize new product candidates from third parties. The upfront payments to acquire licenses, products or rights, as well as any future milestone payments, are immediately recognized as research and development expense provided that there is no alternative future use of the rights in other research and development projects. Any milestone payments made for Intellectual Property after regulatory approval, or that have alternative future use, are capitalized and amortized. Stock-Based Compensation We record stock-based compensation for equity awards granted to employees and directors based on the grant date fair value of awards issued. The expense is recorded over the requisite service period, which is the vesting period, on a straight-line basis. We use the Black-Scholes option-pricing model to determine the fair value of options. The determination of the fair value of options on the date of grant using an option-pricing model is affected by our common stock price, as well as a number of other assumptions. We record forfeitures as they occur. We account for stock-based compensation arrangements with non-employees based upon the fair value of the consideration received or the equity instruments issued, whichever is more reliably measurable. The measurement date for non-employee awards is generally the date performance of services required from the non-employee is complete. Stock-based compensation costs for non-employee awards are recognized as services are provided, which is generally the vesting period, on a straight-line basis. Segments We have one operating segment. Our chief operating decision maker, the Chief Executive Officer, manages our operations on a consolidated basis for the purposes of allocating resources. Net Loss per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of shares of common stock outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by adjusting weighted average shares outstanding for the dilutive effect of common stock equivalents outstanding for the period. For purposes of the dilutive net loss per share applicable to common stockholders calculation stock options, common stock from Employee Stock Purchase Plan (the “ESPP”) and unvested restricted stock are considered to be common stock equivalents but are excluded from the calculation of diluted net loss per share applicable to common stockholders, as their effect would be anti-dilutive; therefore, basic and diluted net loss per share applicable to common stockholders were the same for all periods presented Recently Adopted Accounting Pronouncements Income Taxes In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes. The new standard was effective for us on January 1, 2021, and it includes several provisions which simplify accounting for income taxes by removing certain exceptions to the general principles in Topic 740 and increasing consistency and clarity for the users of financial statements. We adopted ASU No. 2019-12 on January 1, 2021, and have concluded the adoption did not have a material impact on our audited consolidated financial statements. Accounting Pronouncements Issued and Not Adopted as of December 31, 2021 Financial Instruments - Credit Losses In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326)—Measurement of Credit Losses on Financial Instruments, which has been subsequently amended by ASU No. 2018-19, ASU No. 2019-04, ASU No. 2019-05, ASU No. 2019-10, ASU No. 2019-11 and ASU No. 2020-03 (“ASU 2016-13”). The provisions of ASU 2016-13 modify the impairment model to utilize an expected loss methodology in place of the currently used incurred loss methodology and require a consideration of a broader range of reasonable and supportable information to inform credit loss estimates. ASU 2016-13 is effective for us on January 1, 2023, with early adoption permitted. We are currently evaluating the potential impact that this standard may have on our financial position and results of operations, as well as the timing of our adoption of this standard. Debt with Conversion and Other Options On August 5, 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU-2020-06”), which simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity. ASU 2020-06 eliminates the beneficial conversion and cash conversion accounting models in ASC 470-20 that require separate accounting for embedded conversion features from convertible instruments. As a result, after adopting the ASU’s guidance, entities will not separately present in equity an embedded conversion feature in such debt. Additionally, the guidance simplifies the evaluation of whether a contract in the issuer’s own equity can be classified in equity or an embedded feature qualifies for the derivative scope exception. The guidance is effective for 2022, and early adoption of ASU 2020-06 was permitted for all entities for fiscal years beginning after December 15, 2020. We are currently evaluating the impact of this new guidance on the consolidated financial statements and related disclosures. In October 2020, the FASB issued ASU No. 2020-10, Codification Improvements. The amendments improve the codification by having all disclosure-related guidance available in the disclosure sections of the codification. Prior to this ASU, various disclosure requirements or options to present information on the face of the financial statements or as a note to the financial statements were not included in the appropriate disclosure sections of the codification. The codification improvements also contain various other minor amendments to the codification that are not expected to have a significant effect on current accounting practice. The amendments were effective for annual periods beginning after December 15, 2020 and early adoption was permitted. We are currently evaluating the impact of this new guidance on our consolidated financial statements and related disclosures. |
ALJ Commercialization and Licen
ALJ Commercialization and License Agreement | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
ALJ Commercialization and License Agreement | ALJ Commercialization and License Agreement On March 17, 2021, we entered into a commercialization and license agreement (the “ALJ Agreement”) with Meddist Company Limited ("ALJ"). Pursuant to the ALJ Agreement, we granted to ALJ an exclusive, non-transferable, sublicensable license to our product candidate, EDP1815 (together with any replacement or second products of ours described below, the “Products”) solely (i) to conduct development activities relating to the Products allocated to ALJ in a development plan agreed with us, (ii) to conduct manufacturing activities relating to the Products in all therapeutic uses in humans (the “Field”) throughout the world, subject to certain conditions and requirements, and (iii) to commercialize the Products in the Field in all countries of Africa, the Middle East and Turkey, excluding certain restricted countries (the “Territory”). If we cease development of EDP1815 prior to receipt of regulatory approval required for commercialization of EDP1815 in any one of the United States, the United Kingdom, France, Germany, Spain, Italy, China or Japan, (each a “Major Market”), then ALJ will have the right to designate another product candidate of ours as a replacement to EDP1815 or terminate the ALJ Agreement, subject to certain conditions and requirements (the “Replacement Right”). Further, for the first two years of the term, ALJ has the option to negotiate with us to add a second product candidate of ours subject to certain conditions and requirements, for an additional license fee not to exceed $7.5 million (the “Second Product Option”). In consideration for the rights that we granted under the ALJ Agreement, ALJ was obligated to pay to us a one-time, non-refundable upfront payment of $7.5 million. The parties will also share the future operating profits and losses for all Products in the Territory equally (50:50), as well as certain development, regulatory and commercialization costs. We concluded that the delivery of the license to ALJ should be accounted for under ASC 606. The development, regulatory and commercialization activities within the Territory will be accounted for under ASC 808. We concluded that the provision of the license to ALJ represents the only performance obligation, as ALJ can benefit from the license without the other activities under the arrangement upon transfer of control of the license. Specifically, the development, regulatory and commercialization activities within the Territory do not require specialized skills, such that ALJ could obtain those services from a third party other than us. The Replacement Right is considered an attribute of the license that effectively provides ALJ with a right of return on the initial license until we obtain regulatory approval or if we cease development prior to obtaining approval of EDP1815 or a replacement product in a Major Market. The Second Product Option is not considered a performance obligation as the pricing for the second product does not provide the customer with a discount that is incremental to the range of discounts typically given for a license in the geographical area. We have not recognized any revenue under the ALJ Agreement to date as we have not completed any performance obligation within the agreement. As of December 31, 2021, we have recorded $7.5 million of deferred revenue, which is classified as a non-current liability in the accompanying audited consolidated balance sheets as the performance obligation is not expected to be completed within the next twelve months. We anticipate that payments under the costs share or profit and loss sharing arrangements will be classified in the statement of operations consistent with the guidance in ASC 808. To date, we have not received or made any costs sharing or profit and loss payments. Mayo Foundation for Medical Education and Research On June 10, 2016, we entered into a Research and License Agreement, (the “2016 Mayo License Agreement”) with the Mayo Foundation for Medical Education and Research, an affiliate of Mayo Clinic (the “Mayo Clinic”). Under the 2016 Mayo License Agreement, the Mayo Clinic was entitled to certain participation rights in connection with the issuance and sale of preferred stock that was issued prior to our public offering and warrants which were issued in 2016 and exercised in 2018. On August 6, 2017, we and the Mayo Clinic entered into a license agreement, which was subsequently amended (as so amended, the “2017 Mayo License Agreement”). Under the 2017 Mayo License Agreement, the Mayo Clinic granted us (i) an exclusive, worldwide, sublicensable license under the Mayo Clinic’s rights to certain intellectual property and microbial strains and (ii) a non-exclusive, worldwide, sublicensable license to certain related know-how, in each case, to develop and commercialize certain microbial strains and licensed products incorporating any such strains. As consideration, we paid a nonrefundable upfront fee of $0.3 million and will pay annual license maintenance fees. Nonrefundable upfront fees were expensed in full to research and development expense. Annual maintenance fees will be expensed as incurred over the term of the agreement. We may owe the Mayo Clinic milestone payments upon the achievement of certain development, regulatory, and commercial milestones, up to a maximum of $59.1 million in the aggregate, as well as royalties on net sales of licensed products in low single-digit percentages. As of December 31, 2021, we have incurred milestone payments to date totaling approximately $0.3 million under the agreement of which no amounts are currently due. University of Chicago On March 10, 2016, we and the University of Chicago entered into a patent license agreement (“2016 University of Chicago Agreement”). Under the 2016 University of Chicago Agreement, the University of Chicago granted us (i) an exclusive, royalty-bearing and sublicensable license to certain patent rights related to the administration of microbes to treat cancer and (ii) a non-exclusive, royalty-bearing, sublicensable license to access technical information for the development and commercialization of microbial products to treat cancer in combination with checkpoint inhibitors. As consideration, we paid a nonrefundable upfront fee of less than $0.5 million and will pay annual license maintenance fees. Nonrefundable upfront fees were expensed in full to research and development expense in 2016. Annual maintenance fees will be expensed as incurred over the term of the agreement. We may owe the University of Chicago milestone payments, totaling an aggregate of approximately $60.9 million, upon the achievement of certain development, regulatory, and commercial milestones, as well as royalties on net sales of licensed products ranging from low to high single-digit percentages. As of December 31, 2021, we have incurred milestone payments to date totaling approximately $0.4 million under the agreement of which no amounts are currently due. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Leases | Leases In January 2018, we entered into an operating sublease arrangement to lease approximately 40,765 square feet for our office and research development space at 620 Memorial Drive, Cambridge, MA 02139 from February 2018 to September 2025. We maintained an additional separate operating lease for office and laboratory space that expired in May 2020. The leases require security deposits, which we have primarily met with letters of credit from a financial institution that is secured with cash on deposit. In June 2018, we entered into a sublease arrangement with a third party to lease space subject to an operating lease that expired in April 2020. The minimum rental payments received under this agreement totaled $0.2 million for the year ended December 31, 2020, and were equivalent to the minimum payments due from us to the landlord. We recorded rent expense of $3.0 million and $2.9 million for the years ended December 31, 2021 and 2020, respectively. There was no sublease rental income for the year ended December 31, 2021 and rent expense recorded for the year ended December 31, 2020 is net of $0.3 million in sub-lease income. Sublease rental income is inclusive of rental payments, taxes and operating expenses. The minimum aggregate future lease commitments at December 31, 2021, are as follows (in thousands): Amount 2022 2,809 2023 3,154 2024 3,249 2025 2,492 Total lease payments 11,704 Less imputed interest (1,968) Total $ 9,736 Other information: Operating cash flows used for operating leases $ 2,980 Weighted-average remaining lease term (in years) 3.75 Weighted-average discount rate 9.50 % |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements The following tables present information about our financial assets and liabilities that have been measured at fair value as of December 31, 2021 and 2020 (in thousands): Description December 31, 2021 (Level 1) (Level 2) (Level 3) Assets: Money market funds included within cash and cash equivalents $ 66,989 $ 66,989 $ — $ — Total $ 66,989 $ 66,989 $ — $ — Description December 31, 2020 (Level 1) (Level 2) (Level 3) Assets: Money market funds included within cash and cash equivalents $ 64,370 $ 64,370 $ — $ — Total $ 64,370 $ 64,370 $ — $ — As of December 31, 2021 and 2020, our cash equivalents have been initially valued at the transaction price and subsequently valued utilizing a third-party pricing service. We validate the prices provided by our third-party pricing service by understanding the models used and obtaining market values from other pricing sources. |
Property and Equipment, Net
Property and Equipment, Net | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | Property and Equipment, Net Property and equipment consists of the following (in thousands): December 31, 2021 2020 Property and equipment: Lab equipment $ 9,689 $ 8,831 Leasehold improvements 2,157 2,157 Furniture and fixtures 809 822 Computers and software 259 230 Office equipment 21 3 Construction-in-process 1,321 1,078 Property and equipment 14,256 13,121 Less: accumulated depreciation (7,634) (5,643) Property and equipment, net $ 6,622 $ 7,478 We recognized $2.2 million and $2.0 million of depreciation expense for the years ended December 31, 2021 and 2020, respectively. |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2021 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | Accrued Expenses Accrued expenses consist of the following (in thousands): December 31, 2021 2020 Accrued external research and development expenses $ 4,895 $ 9,394 Accrued payroll and related expenses 6,412 5,620 Accrued professional fees 1,013 604 Accrued other 748 636 Total accrued expenses $ 13,068 $ 16,254 |
Loan and Security Agreement
Loan and Security Agreement | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Loan and Security Agreement | Loan and Security Agreement On July 19, 2019, we entered into a loan and security agreement, which was subsequently amended (as amended prior to June 16, 2021, the "2019 Credit Facility") with K2 HealthVentures LLC and others (collectively, "K2HV"), pursuant to which K2HV agreed to make term loans in an aggregate principal amount of up to $45.0 million available to us in three tranches. The initial tranche of $20.0 million was funded upon closing on July 19, 2019. The second tranche of $10.0 million was drawn down on July 14, 2020. The availability of the third tranche of $15.0 million expired on January 15, 2021. On June 16, 2021 (the "Amended Credit Facility Effective Date"), the parties further amended the 2019 Credit Facility (as so amended, the “Amended Credit Facility”) to, among other things, replace and supersede the existing $15.0 million third tranche commitment with a new $15.0 million fourth tranche commitment, which we drew down on June 16, 2021. In connection with the Amended Credit Facility, we issued to K2 HealthVentures Equity Trust LLC, an affiliate of K2HV, a warrant to purchase up to 139,770 shares of our common stock with an exercise price of $13.30 per share, subject to customary per share adjustments that are within our control (the "Warrant”). In addition, under the Amended Credit Facility, K2HV has the option, exercisable at any time, to convert up to $5.0 million of principal outstanding into shares of our common stock at a conversion price of $13.30 per share, subject to customary per share adjustments within our control (the "Conversion Option”). Interest on the outstanding loan balance will accrue at a variable annual rate equal to the greater of (i) 8.65% and (ii) the prime rate plus 3.15%. We are required to make interest-only payments on the loans on a monthly basis through February 28, 2023. Subsequent to the interest only periods, we are required to make equal monthly payments of principal plus interest until the loans mature on August 1, 2024. We have an option to prepay the loans in whole, subject to a prepayment fee of 2% of the amount prepaid or, if the prepayment occurs after the 18-month anniversary of the Amended Credit Facility Effective Date but prior to the maturity date, 1% of the amount prepaid. Pursuant to the Amended Credit Facility, we elected to adjust the repayment schedule (the “Modified Repayment Schedule”) such that commencing on March 1, 2023, we will make consecutive equal monthly payments of principal and accrued and unpaid interest based on a notional thirty month repayment period. Under the Modified Repayment Schedule, the loan maturity date remains August 1, 2024. Any outstanding principal and unpaid interest is due at maturity. Upon final payment or prepayment of the loans, we will pay a final payment equal to 4.8% of the aggregate original principal amount of the loans borrowed. We incurred fees associated with establishing the 2019 Credit Facility and fees related to the Amended Credit Facility of $0.4 million and $0.3 million, respectively. Borrowings under the Amended Credit Facility are collateralized by substantially all of our personal property, excluding intellectual property, and we pledged our equity interests in our subsidiaries, subject to certain limitations with respect to foreign subsidiaries. The Amended Credit Facility contains customary representations, warranties and covenants and also includes customary events of default, including payment defaults, breaches of covenants, change of control and occurrence of a material adverse effect. We have determined that the risk of subjective acceleration under the material adverse events clause was remote and therefore have classified the long-term portion of the outstanding principal in non-current liabilities. Upon the occurrence and continuation of an event of default, a default interest rate of an additional 5% per annum may be applied to the outstanding loan balances, and the administrative agent, collateral agent, and lenders may declare all outstanding obligations immediately due and payable and exercise all of their rights and remedies as set forth in the Amended Credit Facility and under applicable law. As of December 31, 2021, we were in compliance with all covenants under the Amended Credit Facility. We concluded that the Amended Credit Facility resulted in a debt extinguishment for accounting purposes because the terms of the modified debt are considered substantially different than the terms of the debt prior to the amendment on June 16, 2021 and our elections made thereunder . As such, the Amended Credit Facility was recorded at its estimated fair value of $46.6 million which was determined using a combination of a discounted cash flow model and a binomial lattice model. We utilized the following significant unobservable inputs (Level 3 inputs) to determine the estimated fair value of our debt as of the amendment date: Expected volatility 70.00 % Expected yield 11.50 % Significant increases (decreases) in either of these inputs could result in a significantly lower or higher fair value measurement. The Warrant was deemed to be a freestanding financial instrument as it is legally detachable and separately exercisable from the debt obligations. We evaluated the terms and conditions of the Warrant and concluded it met the criteria to be classified within equity. As such, we recorded the Warrant as additional paid in capital at its issuance date fair value of $1.8 million. We utilized the Black-Scholes valuation method to determine the fair value of the Warrant which utilized the following assumptions: Fair value of underlying common stock $ 16.13 Exercise price $ 13.30 Risk-free interest rate 1.56 % Expected volatility 70.00 % Expected term (years) 10.0 Expected dividend yield — % We recorded a loss on the extinguishment of the existing debt of $3.2 million which equaled the difference between the reacquisition cost of the new debt, inclusive of the fair value of the Warrant and lender fees, and the carrying amount of the existing debt. The difference between (i) the carrying amount of the debt and (ii) the par value of the debt and the amount of the final payment due at maturity will be amortized as interest expense using the effective interest rate method. We have the following minimum aggregate future loan payments at December 31, 2021 (in thousands): Twelve-month period ending December 31, Amount 2022 $ 3,947 2023 17,404 2024 34,770 Total minimum payments 56,121 Less amounts representing interest and discount (9,564) Total Debt $ 46,557 Interest expense was approximately $3.7 million for the year ended December 31, 2021, and $2.6 million for the year ended December 31, 2020. |
In-License Agreements
In-License Agreements | 12 Months Ended |
Dec. 31, 2021 | |
Research and Development [Abstract] | |
In-License Agreements | ALJ Commercialization and License Agreement On March 17, 2021, we entered into a commercialization and license agreement (the “ALJ Agreement”) with Meddist Company Limited ("ALJ"). Pursuant to the ALJ Agreement, we granted to ALJ an exclusive, non-transferable, sublicensable license to our product candidate, EDP1815 (together with any replacement or second products of ours described below, the “Products”) solely (i) to conduct development activities relating to the Products allocated to ALJ in a development plan agreed with us, (ii) to conduct manufacturing activities relating to the Products in all therapeutic uses in humans (the “Field”) throughout the world, subject to certain conditions and requirements, and (iii) to commercialize the Products in the Field in all countries of Africa, the Middle East and Turkey, excluding certain restricted countries (the “Territory”). If we cease development of EDP1815 prior to receipt of regulatory approval required for commercialization of EDP1815 in any one of the United States, the United Kingdom, France, Germany, Spain, Italy, China or Japan, (each a “Major Market”), then ALJ will have the right to designate another product candidate of ours as a replacement to EDP1815 or terminate the ALJ Agreement, subject to certain conditions and requirements (the “Replacement Right”). Further, for the first two years of the term, ALJ has the option to negotiate with us to add a second product candidate of ours subject to certain conditions and requirements, for an additional license fee not to exceed $7.5 million (the “Second Product Option”). In consideration for the rights that we granted under the ALJ Agreement, ALJ was obligated to pay to us a one-time, non-refundable upfront payment of $7.5 million. The parties will also share the future operating profits and losses for all Products in the Territory equally (50:50), as well as certain development, regulatory and commercialization costs. We concluded that the delivery of the license to ALJ should be accounted for under ASC 606. The development, regulatory and commercialization activities within the Territory will be accounted for under ASC 808. We concluded that the provision of the license to ALJ represents the only performance obligation, as ALJ can benefit from the license without the other activities under the arrangement upon transfer of control of the license. Specifically, the development, regulatory and commercialization activities within the Territory do not require specialized skills, such that ALJ could obtain those services from a third party other than us. The Replacement Right is considered an attribute of the license that effectively provides ALJ with a right of return on the initial license until we obtain regulatory approval or if we cease development prior to obtaining approval of EDP1815 or a replacement product in a Major Market. The Second Product Option is not considered a performance obligation as the pricing for the second product does not provide the customer with a discount that is incremental to the range of discounts typically given for a license in the geographical area. We have not recognized any revenue under the ALJ Agreement to date as we have not completed any performance obligation within the agreement. As of December 31, 2021, we have recorded $7.5 million of deferred revenue, which is classified as a non-current liability in the accompanying audited consolidated balance sheets as the performance obligation is not expected to be completed within the next twelve months. We anticipate that payments under the costs share or profit and loss sharing arrangements will be classified in the statement of operations consistent with the guidance in ASC 808. To date, we have not received or made any costs sharing or profit and loss payments. Mayo Foundation for Medical Education and Research On June 10, 2016, we entered into a Research and License Agreement, (the “2016 Mayo License Agreement”) with the Mayo Foundation for Medical Education and Research, an affiliate of Mayo Clinic (the “Mayo Clinic”). Under the 2016 Mayo License Agreement, the Mayo Clinic was entitled to certain participation rights in connection with the issuance and sale of preferred stock that was issued prior to our public offering and warrants which were issued in 2016 and exercised in 2018. On August 6, 2017, we and the Mayo Clinic entered into a license agreement, which was subsequently amended (as so amended, the “2017 Mayo License Agreement”). Under the 2017 Mayo License Agreement, the Mayo Clinic granted us (i) an exclusive, worldwide, sublicensable license under the Mayo Clinic’s rights to certain intellectual property and microbial strains and (ii) a non-exclusive, worldwide, sublicensable license to certain related know-how, in each case, to develop and commercialize certain microbial strains and licensed products incorporating any such strains. As consideration, we paid a nonrefundable upfront fee of $0.3 million and will pay annual license maintenance fees. Nonrefundable upfront fees were expensed in full to research and development expense. Annual maintenance fees will be expensed as incurred over the term of the agreement. We may owe the Mayo Clinic milestone payments upon the achievement of certain development, regulatory, and commercial milestones, up to a maximum of $59.1 million in the aggregate, as well as royalties on net sales of licensed products in low single-digit percentages. As of December 31, 2021, we have incurred milestone payments to date totaling approximately $0.3 million under the agreement of which no amounts are currently due. University of Chicago On March 10, 2016, we and the University of Chicago entered into a patent license agreement (“2016 University of Chicago Agreement”). Under the 2016 University of Chicago Agreement, the University of Chicago granted us (i) an exclusive, royalty-bearing and sublicensable license to certain patent rights related to the administration of microbes to treat cancer and (ii) a non-exclusive, royalty-bearing, sublicensable license to access technical information for the development and commercialization of microbial products to treat cancer in combination with checkpoint inhibitors. As consideration, we paid a nonrefundable upfront fee of less than $0.5 million and will pay annual license maintenance fees. Nonrefundable upfront fees were expensed in full to research and development expense in 2016. Annual maintenance fees will be expensed as incurred over the term of the agreement. We may owe the University of Chicago milestone payments, totaling an aggregate of approximately $60.9 million, upon the achievement of certain development, regulatory, and commercial milestones, as well as royalties on net sales of licensed products ranging from low to high single-digit percentages. As of December 31, 2021, we have incurred milestone payments to date totaling approximately $0.4 million under the agreement of which no amounts are currently due. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Collaboration Agreement with Sacco S.r.l. In July 2019, we entered into an agreement with Sacco S.r.l. ("Sacco"), an affiliate of one of our existing contract manufacturing organizations, pursuant to which and subject to certain exceptions for pre-existing products for pre-existing customers, Sacco will manufacture and supply single strain, non-genetically modified microbes intended for oral delivery or oral use in pharmaceutical products exclusively for us for a period of five years. Sacco may terminate the agreement if the provision of manufacturing services has been, or is scheduled to be, inactive for a period of six have incurred annual exclusivity fees to date totaling approximately €1.8 million, and no amounts are currently due as of t he year ended December 31, 2021. We currently have an additional contractual arrangement for manufacturing in place with an affiliate of Sacco that will require us to spend an aggregate minimum amount of €1.5 million annually during each of 2022, 2023, and 2024. Litigation and Other Proceedings We may periodically become subject to legal proceedings and claims arising in connection with on-going business activities, including claims or disputes related to patents that have been issued or that are pending in the field of research on which we are focused. We are not a party to any material litigation and do not have contingency reserves established for any litigation liabilities. On February 12, 2021, the European Patent Office issued a Communication of a Notice of Opposition for European patent EP 3223834, which is held by us. We are currently evaluating our available options and deciding next steps with respect to this matter. The patent at issue does not relate to any of our current product candidates, and receipt of this communication and/or any subsequent proceeding is not expected to affect any of our current development plans. |
Stockholders_ Equity
Stockholders’ Equity | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Stockholders’ Equity | Stockholders’ Equity Common Stock On June 3, 2019, we filed the 2019 Shelf with the SEC in relation to the registration of common stock, preferred stock, debt securities, warrants and/or units of any combination thereof in the aggregate amount of up to $200.0 million for a period of up to three years from the date of the filing. We also simultaneously entered into the ATM, providing for the offering, issuance and sale by us of up to an aggregate $50.0 million of our common stock from time to time in “at-the-market” offerings under the 2019 Shelf. For the year ended December 31, 2021, we issued 139,734 common shares under the ATM with offering prices ranging between $12.54 and $13.17 per share for net proceeds of $1.7 million, after deducting commission and other offering expenses payable by us. For the year ended December 31, 2020, we sold 1,232,131 common shares under the ATM with offering prices ranging between $4.25 to $11.15 per share for gross proceeds of $6.8 million and net proceeds of $6.6 million, after deducting commission and other offering expenses payable by us. On February 2, 2021, we sold 5,175,000 shares of our common stock in an underwritten public offering at a public offering price of $15.00 per share, including the underwriters' exercise of their option to purchase 675,000 shares to cover over-allotment, generating gross proceeds of $77.6 million and net proceeds of $72.7 million, after deducting underwriting discounts, commissions and other offering expenses paid by us. On January 28, 2021, we entered into a stock purchase agreement with ALJ Health Care, pursuant to which on February 2, 2021, ALJ Health Care purchased $7.5 million of our common stock in a private placement at a purchase price of $15.00 per share, equal to the public offering price per share at which our common stock was sold to the public as referred above. The sale of such shares was not registered under the Securities Act. In connection with the entry into the Amended Credit Facility, we issued to K2 HealthVentures Equity Trust LLC, an affiliate of K2HV, the Warrant to purchase up to 139,770 shares of our common stock, with an exercise price of $13.30 per share, subject to customary per share adjustments. The Warrant is exercisable immediately and expires on June 16, 2031, provided that, under certain circumstances, the Warrant may terminate and expire earlier in connection with the closing of certain acquisition transactions involving us. The Warrant provides that the holder thereof may elect to exercise the Warrant on a net “cashless” basis at any time prior to the expiration thereof. The fair market value of one share of our common stock in connection with any cashless exercise shall be the closing price or last sale price per share of our common stock on a nationally recognized securities exchange, inter-dealer quotation system or over-the-counter market on which our common stock is traded on the business day immediately prior to the date the holder elects to exercise the Warrant on a cashless basis. In addition, under the Amended Credit Facility, K2HV has the option, exercisable at any time, to convert up to $5.0 million of principal outstanding into shares of our common stock at a conversion price of $13.30 per share, subject to customary per share adjustments. On August 23, 2021, we filed the 2021 Shelf with the SEC in relation to the registration of common stock, preferred stock, debt securities, warrants and/or units of any combination thereof in the aggregate amount of up to $200.0 million for a period of up to three years from the date of its effectiveness on August 30, 2021. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation 2021 Inducement Plan On May 27, 2021, our board of directors adopted the Evelo Biosciences, Inc. 2021 Employment Inducement Award Plan (the “Inducement Award Plan”) without stockholder approval pursuant to Rule 5635(c)(4) of the Nasdaq Stock Market LLC listing rules (“Rule 5635(c)(4)”). In accordance with Rule 5635(c)(4), cash and equity-based incentive awards under the Inducement Award Plan may only be made to a newly hired employee who has not previously been a member of our board of directors, or an employee who is being rehired following a bona fide period of non-employment by us as a material inducement to the employee’s entering into employment with us. An aggregate of 1,250,000 shares of our common stock has been reserved for issuance under the Inducement Award Plan. We will continue to grant awards under the 2018 Incentive Award Plan (the “2018 Plan”) pursuant to the terms thereof. The exercise price of stock options granted under the Inducement Award Plan will not be less than the fair market value of a share of our common stock on the grant date. Other terms of awards, including vesting requirements, are determined by our board of directors and are subject to the provisions of the Inducement Award Plan. Stock options granted to employees generally vest over a four-year period but may be granted with different vesting terms. Certain options may provide for accelerated vesting in the event of a change in control. Stock options granted under the Inducement Award Plan expire no more than 10 years from the date of grant. As of December 31, 2021, stock option awards covering up to 800,000 shares of our common stock have been issued under the Inducement Award Plan, none of which have been exercised or canceled. As of December 31, 2021, restricted stock unit (“RSU”) awards covering up to 4,545 shares of our common stock have been granted under the Inducement Award Plan, none of which have vested or been forfeited. As of December 31, 2021, 445,455 shares of common stock are available for future grant under the Inducement Award Plan. 2018 Incentive Award Plan Our board of directors adopted on April 18, 2018, and our stockholders approved, the 2018 Plan, which became effective May 8, 2018 and under which we may grant cash and equity-based incentive awards to our employees, officers, directors, consultants and advisors. Following the effectiveness of the 2018 Plan, we ceased making grants under the 2015 Stock Incentive Plan (as amended, the "2015 Plan"). The 2018 Plan initially allowed us to grant awards for up to 1,344,692 shares of common stock plus that number of shares of common stock subject to awards outstanding under the 2015 Plan that expire, lapse or become terminated or are exchanged for cash, surrendered, repurchased, canceled without having been fully exercised or forfeited following the effective date of the 2018 Plan. Each year starting with 2019 and ending in and including 2028, the number of shares available for grants of awards under the 2018 Plan will be increased automatically on January 1 by a number of shares of common stock equal to the lesser of 4% of the shares of common stock outstanding on the final day of the preceding calendar year or the number of shares determined by our board of directors. Accordingly, on January 1, 2022, 2021 and 2019, the number of shares authorized for issuance under the 2018 Plan was increased by 2,143,058 share, 1,898,805 shares, and 1,286,824 shares, respectively. The 2015 Plan continues to govern the terms and conditions of the outstanding awards granted under it. The exercise price of stock options granted under the 2018 Plan will not be less than the fair market value of a share of our common stock on the grant date. Other terms of awards, including vesting requirements, are determined by the board of directors and are subject to the provisions of the 2018 Plan. Stock options granted to employees generally vest over a four-year period but may be granted with different vesting terms. Certain options provide for accelerated vesting in the event of a change in control. Awards granted to non-employee consultants generally vest monthly over a period of one more than 10 years from the date of grant. As of December 31, 2021, stock options awards covering up to 7,078,131 shares of our common stock have been issued under the 2018 Plan, of which 43,247 have been exercised and 1,110,384 have been canceled. As of December 31, 2021, 289,393 shares of common stock are available for future grant under the 2018 Plan. 2015 Stock Incentive Plan Prior to the approval of the 2018 Plan, we granted equity awards under the 2015 Plan, which originally provided for grant of incentive stock options, non-qualified stock options, restricted stock awards, or RSAs, and other stock-based awards to our employees, officers, directors, consultants and advisors. The terms of equity award agreements made under the 2015 Plan, including vesting requirements, were determined by the board of directors and are subject to the provisions of the 2015 Plan. Stock options granted to employees generally vest over a four-year period but may be granted with different vesting terms. A limited number of awards contain performance-based vesting criteria and for such awards that are deemed probable of vesting, we record expense in the period in which such determination is made through any estimated remaining vesting period. Certain options provide for accelerated vesting in the event of a change in control. Awards granted to non-employee consultants generally vest monthly over a period of one Under the 2015 Plan, we were authorized to grant equity awards up to an aggregate of 5,417,044 shares of common stock. As of December 31, 2021, an aggregate of 5,758,518 options and other equity awards had been granted under the 2015 Plan, of which 1,471,337 have been exercised, 1,298,507 have been canceled and 18,468 have been repurchased as of December 31, 2021. A total of 113,006 shares previously reserved under the 2015 Plan that had not been exercised or were otherwise subject to outstanding exercise awards were no longer authorized as of May 8, 2018. Stock-Based Compensation Expense Stock-based compensation expense included in our audited consolidated statements of operations is as follows (in thousands): Years Ended December 31, 2021 2020 General and administrative $ 7,842 $ 3,981 Research and development 8,004 4,487 Total stock-based compensation expense $ 15,846 $ 8,468 Stock Options A summary of our stock option activity and related information is as follows: Shares Weighted- Weighted Average - Remaining Contractual Life (years) Aggregate Intrinsic Value (1) (in thousands) Options outstanding at December 31, 2020 6,610,662 $ 6.55 Granted 3,501,949 14.58 Exercised (133,803) 5.65 Canceled (265,626) 11.14 Options outstanding at December 31, 2021 9,713,182 $ 9.32 7.29 $ 10,409 Exercisable as of December 31, 2021 5,048,264 $ 6.67 6.21 $ 9,720 Exercisable as of Exercisable as of Vested and expected to vest as of December 31, 2021 9,713,182 $ 9.32 7.29 $ 10,409 (1) The aggregate intrinsic value of options is calculated as the difference between the exercise price of the stock options and the fair value of our common stock for those stock options that had exercise prices lower than the fair value of the common stock as of the end of the period. We had 4,664,918 unvested stock options outstanding as of December 31, 2021.The weighted-average fair value of options granted during the years ended December 31, 2021 and 2020 was $10.82 and $4.14, respectively. The aggregate intrinsic value of options exercised during the years ended December 31, 2021 and 2020 was $0.9 million and $0.9 million, respectively. When utilizing the Black-Scholes option-pricing model to determine the grant date fair value of stock options granted to employees or non-employees, we used the following weighted average, or ranges of, assumptions: Employee option grants Year Ended December 31, 2021 2020 Risk-free interest rate 0.77 % 1.11 % Expected life (in years) 6.02 6.05 Volatility 90.21 % 79.60 % Expected dividend rate 0.00 % 0.00 % Expected Term: The expected term represents the period that the options granted are expected to be outstanding and is determined using the simplified method (based on the mid-point between the vesting date and the end of the contractual term). The expected life is applied to the stock option grant group as a whole as we do not expect substantially different exercise or post-vesting termination behavior among our employee population. Expected Volatility: We used an average historical stock price volatility of comparable public companies within the biotechnology and pharmaceutical industry that were deemed to be representative of future stock price trends as we do not have sufficient trading history for our common stock. Risk-Free Interest Rate: We based the risk-free interest rate over the expected term of the options based on the constant maturity rate of U.S. Treasury securities with similar maturities as of the date of the grant. Expected Dividend: We have not paid and do not anticipate paying any dividends in the near future. Therefore, the expected dividend yield was zero. Non-employee option grants Year Ended December 31, 2021 2020 Risk-free interest rate 0.98 % 0.38 % Expected life (in years) 5.74 5.21 Volatility 90.87 % 78.90 % Expected dividend rate 0.00 % 0.00 % We estimate the expected life of options granted based on the remaining contractual term of the option for options granted to non-employees. As of December 31, 2021, total unrecognized stock-based compensation expense relating to unvested stock options was $36.5 million. This amount is expected to be recognized over a weighted average period of 2.62 years. Restricted Stock Units We issue restricted stock units ("RSU") under our 2018 Plan and 2021 Inducement Plan. Typically, each award of RSUs vests as to 25% on the first anniversary of the grant date, and either monthly thereafter or annually over three additional years. A summary of the restricted stock unit ("RSU") activity and related information is as follows: Shares Weighted- Unvested balance at December 31, 2020 284,000 $ 4.41 Granted 172,450 15.50 Vested (93,054) 7.37 Forfeited (43,187) 7.98 Unvested balance at December 31, 2021 320,209 $ 9.04 Stock-based compensation expense related to RSUs was $1.1 million, for the year ended December 31, 2021. 2018 Employee Stock Purchase Plan Our board of directors adopted on April 18, 2018, and our stockholders approved, the 2018 Employee Stock Purchase Plan (the “ESPP”), which became effective on May 8, 2018. A total of 336,356 shares of common stock were initially reserved for issuance under the ESPP. In addition, the number of shares of common stock that may be issued under the ESPP will automatically increase on the first day of each calendar year, beginning in 2020 and ending in and including 2028, by an amount equal to the lesser of (i) 1% of the number of shares of our common stock outstanding on the last day of the applicable preceding calendar year and (ii) an amount determined by our board of directors. Our board of directors authorized an initial offering period under the ESPP commencing on February 1, 2020. Accordingly, on January 1, 2022, the number of shares authorized for issuance under the ESPP was increased by 535,765 shares. The compensation expense recognized related to the ESPP for the years ended December 31, 2021 and 2020 was $0.2 million and $0.1 million, respectively. There was a total of 46,358 shares purchased under the ESPP during the year ended December 31, 2021. There were 28,603 shares purchased under the ESPP during the year ended December 31, 2020. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes We recorded a tax provision of $0.4 million and $0.4 million for the years ended December 31, 2021 and 2020, respectively. We did not record a tax benefit for the periods presented due to the losses incurred and the need for a full valuation allowance on net deferred tax assets. The tax expense recorded for the December 31, 2021 and 2020 periods primarily relates to current tax expense at our UK subsidiary and current year Massachusetts security corporation taxes. The difference between the income tax expense at the U.S. federal statutory rate and the recorded provision is primarily due to the valuation allowance provided on our net deferred tax assets. Our loss before income tax for the periods presented was generated primarily in the United States, with a small amount of income generated by our subsidiary in the United Kingdom. December 31, 2021 2020 U.S. federal tax statutory rate 21.0 % 21.0 % State taxes, net of federal benefit 6.5 % 6.8 % Non-deductible stock compensation (0.7) % (1.0) % Other non-deductible expenses (0.5) % (0.4) % Credits 1.8 % 1.8 % Change in valuation allowance (28.50) % (28.6) % Total (0.4) % (0.4) % December 31, 2021 2020 Deferred tax assets: Net operating loss carryforwards $ 51,653 $ 36,256 Research and development credits 9,879 7,092 Capitalized research and development, patent and start-up costs 47,511 34,452 Accrued expenses 1,219 1,370 Stock based compensation 6,262 3,443 Operating lease liability 2,660 3,186 Right of use asset – operating lease (2,434) (2,939) Depreciation (78) (208) Other 729 — Deferred tax assets before valuation allowance 117,401 82,652 Valuation allowance (117,401) (82,652) Net deferred tax assets $ — $ — As of December 31, 2021, we had approximately $189.7 million and $187.1 million of U.S. federal and state net operating losses (“NOLs”), respectively. The U.S. federal NOLs include $49.9 million which expire at various dates through 2036, and $139.7 million which carryforward indefinitely. The state NOLs expire at various dates through 2041. As of December 31, 2021, we had U.S. federal and state research credits of $7.2 million and $3.3 million, respectively, which expire at various dates through 2041. Realization of future tax benefits is dependent on many factors, including our ability to generate taxable income within the net operating loss carryforward period. Under the United States Internal Revenue Code provisions, certain substantial changes in our ownership, including the sale of our business or significant changes in ownership due to sales of equity, have limited and may limit in the future, the amount of net operating loss carryforwards which could be used annually to offset future taxable income. We have not yet completed an analysis of ownership changes. We may also experience ownership changes in the future as a result of subsequent shifts in our stock ownership, some of which may be outside of our control. As a result, our ability to use our pre-change NOLs to offset U.S. federal taxable income may be subject to limitations, which could potentially result in increased future tax liability to us. In addition, at the state level, there may be periods during which the use of NOLs is suspended or otherwise limited, which could accelerate or permanently increase state taxes owed. All federal NOLs generated post tax reform will have an indefinite life, are not subject to carry-back provisions and limited to 80% of income in any year. We have evaluated the positive and negative evidence bearing upon our ability to realize the deferred tax assets. We have considered our history of cumulative net losses incurred since inception and our lack of commercialization of any products or generation of any revenue from product sales since inception, and have concluded that it is more likely than not that we will not realize the benefits of the deferred tax assets. Accordingly, a full valuation allowance has been established against the net deferred tax assets as of December 31, 2021 and 2020, respectively. The valuation allowance increased by $34.7 million in 2021 primarily due to increases in net operating losses and research and development credits. We reevaluate the positive and negative evidence at each reporting period. As of December 31, 2021 and 2020, we had no unrecognized tax benefits, respectively. Interest and penalty charges, if any, related to unrecognized tax benefits would be classified as income tax expense. We do not expect any significant change in our uncertain tax positions in the next twelve months. |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2021 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | Net Loss Per Share Basic net loss per common share is determined by dividing the net loss by the weighted-average common shares outstanding during the period, without consideration of common stock equivalents. Diluted net loss per share is calculated by adjusting weighted average shares outstanding for the dilutive effect of common stock equivalents outstanding for the period. For purposes of the dilutive net loss per share applicable to common stockholders calculation stock options, common stock from the ESPP and unvested restricted stock and exercise of the Warrant and Conversion Option under the Amended Credit Facility are considered to be common stock equivalents but are excluded from the calculation of diluted net loss per share applicable to common stockholders, as their effect would be anti-dilutive; therefore, basic and diluted net loss per share applicable to common stockholders were the same for all periods presented. The following table presents securities that have been excluded from the computations of diluted weighted-average shares outstanding as they would be anti-dilutive: Year Ended December 31, 2021 2020 Unvested common stock from early exercise of options — 18,386 Stock options to purchase common stock 9,713,182 6,610,662 Warrant 139,770 — RSUs 320,209 284,000 Conversion option 375,940 — Common stock from the ESPP 13,152 24,508 Total 10,562,253 6,937,556 |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2021 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Related Party Transactions We receive clinical advisory services from Weatherden Ltd. (“Weatherden”) under agreements that were entered into during 2017 and 2018. Duncan McHale, our Chief Medical Officer, is a part owner of Weatherden. During the years ended December 31, 2021 and 2020, we paid $0.3 million and $0.6 million, respectively, to Weatherden under the supply of service agreement. We entered into a consulting agreement with David Epstein (the "Consulting Agreement"), our Chairman of the Board, effective September 16, 2019 pursuant to which Mr. Epstein provides strategic advisory and other consulting services to us. The Consulting Agreement was amended on October 15, 2020 and again on April 9, 2021, and now has a term that is scheduled to end on June 30, 2022 unless terminated earlier by either Mr. Epstein or by us upon 30 days’ notice, or 24 hours’ notice by the non-breaching party in the event of a breach. In accordance with the terms of the Consulting Agreement, on September 16, 2019, Mr. Epstein was granted an option to purchase 75,000 shares of our common stock, which award vests in 36 equal monthly installments subject to his continued provision of consulting services to us pursuant to the Consulting Agreement on the applicable vesting dates. Under the Consulting Agreement as amended on October 15, 2020, Mr. Epstein also is entitled to receive (i) an annual equity |
Defined Contribution Plan
Defined Contribution Plan | 12 Months Ended |
Dec. 31, 2021 | |
Retirement Benefits [Abstract] | |
Defined Contribution Plan | Defined Contribution PlanWe provide benefits under certain retirement benefit plans. Our most significant defined contribution plan is in the United States, which is administered through a third-party administrator. Under the U.S. defined contribution plan employees may elect to defer up to 85.0% of their compensation per year (subject to a maximum limit prescribed by federal tax law) and we match a portion of such employee contributions. For the years ended December 31, 2021 and 2020, our matching contribution expense totaled $0.3 million and $0.3 million, respectively. |
Subsequent Event
Subsequent Event | 12 Months Ended |
Dec. 31, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Event | Subsequent EventNot applicable. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the accrual of research and development expenses and the valuation of stock-based awards. We base our estimates on historical experience and other market-specific or other relevant assumptions that we believe to be reasonable under the circumstances. Actual results could differ from those estimates. |
Principles of Consolidation | Principles of Consolidation The consolidated financial statements include the accounts of our business and our wholly owned, controlled subsidiaries. All intercompany transactions and balances have been eliminated in consolidation. |
Subsequent Event Considerations | Subsequent Event Considerations We consider events or transactions that occur after the balance sheet date but prior to the issuance of the consolidated financial statements to provide additional evidence for certain estimates or to identify matters that require additional disclosure. Subsequent events have been evaluated as required. We have evaluated all subsequent events and determined that there are no material recognized or unrecognized subsequent events requiring disclosure. |
Emerging Growth Company Status | Emerging Growth Company Status We are an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012 (the "JOBS Act"), and we may take advantage of reduced reporting requirements that are otherwise applicable to public companies. We may take advantage of these exemptions until we no longer are an emerging growth company. Section 107 of the JOBS Act provides that an emerging growth company can take advantage of the extended transition period afforded by the JOBS Act for the implementation of new or revised accounting standards. We have elected to use the extended transition period for complying with new or revised accounting standards and, as a result of this election, our consolidated financial statements may not be comparable to companies that comply with public company effective dates. We may take advantage of these exemptions up until the last day of the fiscal year following the fifth anniversary of our IPO or such earlier time that we no longer are an emerging growth company. We would cease to be an emerging growth company if we have more than $1.07 billion in annual revenue, have more than $700.0 million in market value of our stock held by non-affiliates (and have been a public company for at |
Concentrations of Credit Risk and Off-Balance Sheet Risk | Concentrations of Credit Risk and Off-Balance Sheet Risk Financial instruments that potentially expose us to concentrations of credit risk primarily consist of cash and cash equivalents. We place our cash and cash equivalents in primarily two custodian accounts at accredited financial institutions. Such deposits have and will continue to exceed federally insured limits. As of December 31, 2021 and 2020, we have no off-balance sheet risk such as foreign exchange contracts, option contracts, or other foreign hedging arrangements. We are subject to a number of risks similar to other early-stage biopharmaceutical companies including, but not limited to, the need to obtain adequate additional funding, possible failure of current or future preclinical testing or clinical trials, our reliance on third parties to conduct our clinical trials, the need to obtain regulatory and marketing approvals for our product candidates, competitors developing new technological innovations, the need to successfully commercialize and gain market acceptance of our product candidates, our right to develop and commercialize our product candidates pursuant to the terms and conditions of the licenses granted to us, protection of proprietary technology, the ability to make milestone, royalty or other payments due under any license or collaboration agreements, and the need to secure and maintain adequate manufacturing arrangements. If we do not successfully commercialize, license or partner any of our product candidates, we will be unable to generate product revenue or achieve profitability. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss consists of net loss and changes in equity during a period from transactions and other equity and circumstances generated from non-owner sources. Our net loss equals comprehensive loss for all periods presented. |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted CashCash equivalents are comprised of highly liquid investments that are readily convertible into cash with original maturities of three months or less. Cash and cash equivalents include cash held in banks and amounts held in money market funds. Our restricted cash consists of deposit requirements in connection with the lease for our headquarters office and laboratory premises and related to our credit card facility. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments ASC 820, Fair Value Measurement (“ASC 820”), establishes a fair value hierarchy for instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and our own assumptions (unobservable inputs). Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of us. Unobservable inputs are inputs that reflect our assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances. ASC 820 identifies fair value as the exchange price, or exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As a basis for considering market participant assumptions in fair value measurements, ASC 820 establishes a three-tier fair value hierarchy that distinguishes between the following: • Level 1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities; • Level 2 inputs are inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly; and • Level 3 inputs are unobservable inputs that reflect our own assumptions about the assumptions market participants would use in pricing the asset or liability. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment we exercise in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. An entity may choose to measure many financial instruments and certain other items at fair value at specified election dates. Subsequent unrealized gains and losses on items for which the fair value option has been elected will be reported in earnings. We did not elect to measure any additional financial instruments or other items at fair value. |
Property and Equipment | Property and Equipment Property and equipment consists of computer hardware and software, furniture and fixtures, office equipment, research and lab equipment, and leasehold improvement recorded at cost. Lab equipment used in research and development activities is only capitalized when it has an alternative future use. These amounts are depreciated using the straight-line method over the estimated useful lives of the assets. Purchased assets that are not yet in service are recorded to construction-in-process and no depreciation expense is recorded. Once they are placed in service they are reclassified to the appropriate asset class. A summary of the estimated useful lives is as follows: Classification Estimated Useful Life Computer hardware 3 - 5 years Computer software 3 years Furniture and fixtures 7 years Research and lab equipment (used/new) 3 - 5 years Leasehold improvements Lesser of asset life or remaining life of lease Repairs and maintenance costs are expensed as incurred. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets We periodically evaluate property and equipment for impairment whenever events or changes in circumstances indicate that a potential impairment may have occurred. If such events or changes in circumstances arise, we compare the carrying amount of the long-lived assets to the estimated future undiscounted cash flows expected to be generated by the long-lived assets. If the estimated aggregate undiscounted cash flows are less than the carrying amount of the long-lived assets, an impairment charge, calculated as the amount by which the carrying amount of the assets exceeds the fair value of the assets, is recorded. The fair value of the long-lived assets is determined based on the estimated discounted cash flows expected to be generated from the long-lived assets. We have not recorded any material impairment charges during the years presented. |
Income Taxes | Income Taxes We record deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the financial statement carrying amounts and the tax bases of assets and liabilities and for loss and credit carryforwards using enacted tax rates expected to be in effect in the years in which the differences reverse. A valuation allowance is provided to reduce the net deferred tax assets to the amount that will more likely than not be |
Collaboration Agreements | Collaboration Agreements We analyze our collaboration arrangements to assess whether they are within the scope of ASC 808, Collaborative Arrangements ("ASC 808") to determine whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards that are dependent on the commercial success of such activities. To the extent the arrangement is within the scope of ASC 808, we assess whether aspects of the arrangement between us and our collaboration partner are within the scope of other accounting literature, including ASC 606. If it is concluded that some or all aspects of the arrangement represent a transaction with a customer, we will account for those aspects of the arrangement within the scope of ASC 606. ASC 808 provides guidance for the presentation and disclosure of transactions in collaborative arrangements, but it does not provide recognition or measurement guidance. Therefore, if we conclude a counterparty to a transaction is not a customer or otherwise not within the scope of ASC 606, we consider the guidance in other accounting literature, including the guidance in ASC 606, as applicable or by analogy to account for such transaction. The classification of transactions under our arrangements is determined based on the nature and contractual terms of the arrangement along with the nature of the operations of the participants. |
Revenue Recognition and Contract Liabilities | Revenue Recognition To determine the appropriate amount of revenue to be recognized for arrangements that we determine are within the scope of ASC 606, we perform the following steps: (i) identify the contract(s) with the customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) each performance obligation is satisfied. ASC 606 requires significant judgment and estimates and results in changes to, but not limited to: (i) the determination of the transaction price, including estimates of variable consideration, (ii) the allocation of the transaction price, including the determination of estimated selling price, and (iii) the pattern of recognition, including the application of proportional performance as a measure of progress on service-related promises and application of point-in-time recognition for supply-related promises. The promised good or services in our arrangement may consist of license rights to our intellectual property or research and development services. We also may have optional additional items in contracts, which are considered marketing offers and are accounted for as separate contracts with the customer if such option is elected by the customer, unless the option provides a material right which would not be provided without entering into the contract. Performance obligations are promised goods or services in a contract to transfer a distinct good or service to the customer. Promised goods or services are considered distinct when (i) the customer can benefit from the good or service on its own or together with other readily available resources, or (ii) the promised good or service is separately identifiable from other promises in the contract. In assessing whether promised goods or services are distinct, we consider factors such as the stage of development of the underlying intellectual property, the capabilities of the customer to develop the intellectual property on their own or whether the required expertise is readily available. The transaction price may be comprised of fixed payments, often an upfront payment due at contract inception, or other types of variable consideration in the form of payments for our services and materials and milestone payments due upon the achievement of specified events. Other payments we could be entitled to include tiered royalties earned when customers recognize net sales of licensed products. We consider the existence of any significant financing component within its arrangements to the extent there is a significant difference between the timing of payment and the transfer of control of the performance obligations. In making that determination, we consider whether substantive business purposes exist to support the payment structure other than to provide a significant benefit of financing. We measure the transaction price based on the amount of consideration to which it expects to be entitled in exchange for transferring the promised goods and/or services to the customer. We utilize either the expected value method or the most likely amount method to estimate the amount of variable consideration, depending on which method is expected to better predict the amount of consideration to which we will be entitled. Amounts of variable consideration are included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. With respect to arrangements that include payments for a development or regulatory milestone payment, we evaluate whether the associated event is considered probable of achievement and estimates the amount to be included in the transaction price using the most likely amount method. Milestone payments that are not within our or the licensee’s control, such as those dependent upon receipt of regulatory approval, are not considered to be probable of achievement until the triggering event occurs. At the end of each reporting period, we re-evaluate the probability of achievement of each milestone and any related constraint, and if necessary, adjusts our estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenue and net loss in the period of adjustment. For arrangements that include sales-based royalties, including milestone payments based upon the achievement of a certain level of product sales, wherein the license is deemed to be the sole or predominant item to which the payments relate, we recognize revenue upon the later of: (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the payment has been allocated has been satisfied (or partially satisfied). Consideration that would be received for optional goods and/or services is excluded from the transaction price at contract inception. For arrangements with more than one performance obligation, we generally allocate the transaction price to each performance obligation based on a relative standalone selling price basis. We develop assumptions that require judgment to determine the standalone selling price for each performance obligation in consideration of applicable market conditions and relevant entity-specific factors, including factors that were contemplated in negotiating the agreement with the customer and estimated research and development costs. However, in certain instances, we may allocate variable consideration entirely to one or more performance obligation if the terms of the variable consideration relate to the satisfaction of the respective performance obligation and the amount allocated is consistent with the amount we would expect to receive for the satisfaction of the respective performance obligation. We recognize revenue based on the amount of the transaction price that is allocated to each respective performance obligation when or as the performance obligation is satisfied by transferring a promised good or service to the customer. For performance obligations that are satisfied at a point in time, we recognize revenue when control of the goods and/or services is transferred to the customer. For performance obligations that are satisfied over time, we recognize revenue by measuring the progress toward complete satisfaction of the performance obligation using a single method of measuring progress which depicts the performance in transferring control of the associated goods and/or services to the customer. With respect to arrangements containing a license to our intellectual property that is determined to be distinct from the other performance obligations identified in the arrangement, we recognize revenue from amounts allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, we utilize judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue. Significant management judgment is required in determining the level of effort required under an arrangement and the period over which we are expected to complete our performance obligations under an arrangement. We evaluate the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenue and net loss in the period of adjustment. Contract Liabilities We record a contract liability, classified as deferred revenue on our consolidated balance sheet, when it has received payment but has not yet satisfied the related performance obligations. In the event of an early termination of a contract with a customer, any contract liabilities would be recognized in the period in which all our obligations under the agreement have been fulfilled. |
Research and Development Costs | Research and Development Costs Research and development costs are expensed in the period incurred. Research and development expenses consist of both internal and external costs such as payroll, consulting, and manufacturing costs associated with the development of our product candidates. Costs for certain development activities, such as clinical trials and manufacturing development activities, are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, and information provided to us by our vendors on their actual costs incurred or level of effort expended. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected on the audited consolidated balance sheets as prepaid or accrued research and development expenses. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are deferred and capitalized. The capitalized amounts are expensed as the related goods are delivered or the services are performed. We have and may continue to acquire the rights to develop and commercialize new product candidates from third parties. The upfront payments to acquire licenses, products or rights, as well as any future milestone payments, are immediately recognized as research and development expense provided that there is no alternative future use of the rights in other research and development projects. Any milestone payments made for Intellectual Property after regulatory approval, or that have alternative future use, are capitalized and amortized. |
Stock-Based Compensation | Stock-Based Compensation We record stock-based compensation for equity awards granted to employees and directors based on the grant date fair value of awards issued. The expense is recorded over the requisite service period, which is the vesting period, on a straight-line basis. We use the Black-Scholes option-pricing model to determine the fair value of options. The determination of the fair value of options on the date of grant using an option-pricing model is affected by our common stock price, as well as a number of other assumptions. We record forfeitures as they occur. We account for stock-based compensation arrangements with non-employees based upon the fair value of the consideration received or the equity instruments issued, whichever is more reliably measurable. The measurement date for non-employee awards is generally the date performance of services required from the non-employee is complete. Stock-based compensation costs for non-employee awards are recognized as services are provided, which is generally the vesting period, on a straight-line basis. |
Segments | Segments We have one operating segment. Our chief operating decision maker, the Chief Executive Officer, manages our operations on a consolidated basis for the purposes of allocating resources. |
Net Loss per Share | Net Loss per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of shares of common stock outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by adjusting weighted average shares outstanding for the dilutive effect of common stock equivalents outstanding for the period. For purposes of the dilutive net loss per share applicable to common stockholders calculation stock options, common stock from Employee Stock Purchase Plan (the “ESPP”) and unvested restricted stock are considered to be common stock equivalents but are excluded from the calculation of diluted net loss per share applicable to common stockholders, as their effect would be anti-dilutive; therefore, basic and diluted net loss per share applicable to common stockholders were the same for all periods presented |
Recently Adopted Accounting Pronouncements and Accounting Pronouncements Issued and Not Adopted | Recently Adopted Accounting Pronouncements Income Taxes In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes. The new standard was effective for us on January 1, 2021, and it includes several provisions which simplify accounting for income taxes by removing certain exceptions to the general principles in Topic 740 and increasing consistency and clarity for the users of financial statements. We adopted ASU No. 2019-12 on January 1, 2021, and have concluded the adoption did not have a material impact on our audited consolidated financial statements. Accounting Pronouncements Issued and Not Adopted as of December 31, 2021 Financial Instruments - Credit Losses In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326)—Measurement of Credit Losses on Financial Instruments, which has been subsequently amended by ASU No. 2018-19, ASU No. 2019-04, ASU No. 2019-05, ASU No. 2019-10, ASU No. 2019-11 and ASU No. 2020-03 (“ASU 2016-13”). The provisions of ASU 2016-13 modify the impairment model to utilize an expected loss methodology in place of the currently used incurred loss methodology and require a consideration of a broader range of reasonable and supportable information to inform credit loss estimates. ASU 2016-13 is effective for us on January 1, 2023, with early adoption permitted. We are currently evaluating the potential impact that this standard may have on our financial position and results of operations, as well as the timing of our adoption of this standard. Debt with Conversion and Other Options On August 5, 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU-2020-06”), which simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity. ASU 2020-06 eliminates the beneficial conversion and cash conversion accounting models in ASC 470-20 that require separate accounting for embedded conversion features from convertible instruments. As a result, after adopting the ASU’s guidance, entities will not separately present in equity an embedded conversion feature in such debt. Additionally, the guidance simplifies the evaluation of whether a contract in the issuer’s own equity can be classified in equity or an embedded feature qualifies for the derivative scope exception. The guidance is effective for 2022, and early adoption of ASU 2020-06 was permitted for all entities for fiscal years beginning after December 15, 2020. We are currently evaluating the impact of this new guidance on the consolidated financial statements and related disclosures. In October 2020, the FASB issued ASU No. 2020-10, Codification Improvements. The amendments improve the codification by having all disclosure-related guidance available in the disclosure sections of the codification. Prior to this ASU, various disclosure requirements or options to present information on the face of the financial statements or as a note to the financial statements were not included in the appropriate disclosure sections of the codification. The codification improvements also contain various other minor amendments to the codification that are not expected to have a significant effect on current accounting practice. The amendments were effective for annual periods beginning after December 15, 2020 and early adoption was permitted. We are currently evaluating the impact of this new guidance on our consolidated financial statements and related disclosures. |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Schedule of Reconciliation of Cash, Cash Equivalents and Restricted cash | The following reconciles cash, cash equivalents and restricted cash as of December 31, 2021 and 2020, as presented on the consolidated statements of cash flows, to our related consolidated balance sheet accounts (in thousands): December 31, 2021 2020 Cash and cash equivalents: Cash $ 1,452 $ 4,487 Money market funds 66,989 64,370 Total cash and cash equivalents 68,441 68,857 Restricted cash 1,313 1,563 Cash, cash equivalents and restricted cash $ 69,754 $ 70,420 |
Schedule of Reconciliation of Cash, Cash Equivalents and Restricted cash | The following reconciles cash, cash equivalents and restricted cash as of December 31, 2021 and 2020, as presented on the consolidated statements of cash flows, to our related consolidated balance sheet accounts (in thousands): December 31, 2021 2020 Cash and cash equivalents: Cash $ 1,452 $ 4,487 Money market funds 66,989 64,370 Total cash and cash equivalents 68,441 68,857 Restricted cash 1,313 1,563 Cash, cash equivalents and restricted cash $ 69,754 $ 70,420 |
Schedule of Estimated Useful Lives of Property and Equipment | A summary of the estimated useful lives is as follows: Classification Estimated Useful Life Computer hardware 3 - 5 years Computer software 3 years Furniture and fixtures 7 years Research and lab equipment (used/new) 3 - 5 years Leasehold improvements Lesser of asset life or remaining life of lease Property and equipment consists of the following (in thousands): December 31, 2021 2020 Property and equipment: Lab equipment $ 9,689 $ 8,831 Leasehold improvements 2,157 2,157 Furniture and fixtures 809 822 Computers and software 259 230 Office equipment 21 3 Construction-in-process 1,321 1,078 Property and equipment 14,256 13,121 Less: accumulated depreciation (7,634) (5,643) Property and equipment, net $ 6,622 $ 7,478 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Schedule of Minimum Aggregate Future Lease Commitments | The minimum aggregate future lease commitments at December 31, 2021, are as follows (in thousands): Amount 2022 2,809 2023 3,154 2024 3,249 2025 2,492 Total lease payments 11,704 Less imputed interest (1,968) Total $ 9,736 Other information: Operating cash flows used for operating leases $ 2,980 Weighted-average remaining lease term (in years) 3.75 Weighted-average discount rate 9.50 % |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Schedule of Financial Assets and Liabilities Measured at Fair Value | The following tables present information about our financial assets and liabilities that have been measured at fair value as of December 31, 2021 and 2020 (in thousands): Description December 31, 2021 (Level 1) (Level 2) (Level 3) Assets: Money market funds included within cash and cash equivalents $ 66,989 $ 66,989 $ — $ — Total $ 66,989 $ 66,989 $ — $ — Description December 31, 2020 (Level 1) (Level 2) (Level 3) Assets: Money market funds included within cash and cash equivalents $ 64,370 $ 64,370 $ — $ — Total $ 64,370 $ 64,370 $ — $ — |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | A summary of the estimated useful lives is as follows: Classification Estimated Useful Life Computer hardware 3 - 5 years Computer software 3 years Furniture and fixtures 7 years Research and lab equipment (used/new) 3 - 5 years Leasehold improvements Lesser of asset life or remaining life of lease Property and equipment consists of the following (in thousands): December 31, 2021 2020 Property and equipment: Lab equipment $ 9,689 $ 8,831 Leasehold improvements 2,157 2,157 Furniture and fixtures 809 822 Computers and software 259 230 Office equipment 21 3 Construction-in-process 1,321 1,078 Property and equipment 14,256 13,121 Less: accumulated depreciation (7,634) (5,643) Property and equipment, net $ 6,622 $ 7,478 |
Payables and Accruals (Tables)
Payables and Accruals (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consist of the following (in thousands): December 31, 2021 2020 Accrued external research and development expenses $ 4,895 $ 9,394 Accrued payroll and related expenses 6,412 5,620 Accrued professional fees 1,013 604 Accrued other 748 636 Total accrued expenses $ 13,068 $ 16,254 |
Loan and Security Agreement (Ta
Loan and Security Agreement (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Schedule of Fair Value Measurement Inputs and Valuation Techniques | We utilized the following significant unobservable inputs (Level 3 inputs) to determine the estimated fair value of our debt as of the amendment date: Expected volatility 70.00 % Expected yield 11.50 % Fair value of underlying common stock $ 16.13 Exercise price $ 13.30 Risk-free interest rate 1.56 % Expected volatility 70.00 % Expected term (years) 10.0 Expected dividend yield — % |
Schedule of Minimum Aggregate Future Loan Payments | We have the following minimum aggregate future loan payments at December 31, 2021 (in thousands): Twelve-month period ending December 31, Amount 2022 $ 3,947 2023 17,404 2024 34,770 Total minimum payments 56,121 Less amounts representing interest and discount (9,564) Total Debt $ 46,557 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of Stock-based Compensation Expense | Stock-based compensation expense included in our audited consolidated statements of operations is as follows (in thousands): Years Ended December 31, 2021 2020 General and administrative $ 7,842 $ 3,981 Research and development 8,004 4,487 Total stock-based compensation expense $ 15,846 $ 8,468 |
Schedule of Stock Option Activity | A summary of our stock option activity and related information is as follows: Shares Weighted- Weighted Average - Remaining Contractual Life (years) Aggregate Intrinsic Value (1) (in thousands) Options outstanding at December 31, 2020 6,610,662 $ 6.55 Granted 3,501,949 14.58 Exercised (133,803) 5.65 Canceled (265,626) 11.14 Options outstanding at December 31, 2021 9,713,182 $ 9.32 7.29 $ 10,409 Exercisable as of December 31, 2021 5,048,264 $ 6.67 6.21 $ 9,720 Exercisable as of Exercisable as of Vested and expected to vest as of December 31, 2021 9,713,182 $ 9.32 7.29 $ 10,409 (1) The aggregate intrinsic value of options is calculated as the difference between the exercise price of the stock options and the fair value of our common stock for those stock options that had exercise prices lower than the fair value of the common stock as of the end of the period. |
Schedule of Stock Option Valuation Assumptions | When utilizing the Black-Scholes option-pricing model to determine the grant date fair value of stock options granted to employees or non-employees, we used the following weighted average, or ranges of, assumptions: Employee option grants Year Ended December 31, 2021 2020 Risk-free interest rate 0.77 % 1.11 % Expected life (in years) 6.02 6.05 Volatility 90.21 % 79.60 % Expected dividend rate 0.00 % 0.00 % Non-employee option grants Year Ended December 31, 2021 2020 Risk-free interest rate 0.98 % 0.38 % Expected life (in years) 5.74 5.21 Volatility 90.87 % 78.90 % Expected dividend rate 0.00 % 0.00 % |
Schedule of Restricted Stock Unit Activity | A summary of the restricted stock unit ("RSU") activity and related information is as follows: Shares Weighted- Unvested balance at December 31, 2020 284,000 $ 4.41 Granted 172,450 15.50 Vested (93,054) 7.37 Forfeited (43,187) 7.98 Unvested balance at December 31, 2021 320,209 $ 9.04 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Schedule of Effective Income Tax Rate Reconciliation | The difference between the income tax expense at the U.S. federal statutory rate and the recorded provision is primarily due to the valuation allowance provided on our net deferred tax assets. Our loss before income tax for the periods presented was generated primarily in the United States, with a small amount of income generated by our subsidiary in the United Kingdom. December 31, 2021 2020 U.S. federal tax statutory rate 21.0 % 21.0 % State taxes, net of federal benefit 6.5 % 6.8 % Non-deductible stock compensation (0.7) % (1.0) % Other non-deductible expenses (0.5) % (0.4) % Credits 1.8 % 1.8 % Change in valuation allowance (28.50) % (28.6) % Total (0.4) % (0.4) % December 31, 2021 2020 Deferred tax assets: Net operating loss carryforwards $ 51,653 $ 36,256 Research and development credits 9,879 7,092 Capitalized research and development, patent and start-up costs 47,511 34,452 Accrued expenses 1,219 1,370 Stock based compensation 6,262 3,443 Operating lease liability 2,660 3,186 Right of use asset – operating lease (2,434) (2,939) Depreciation (78) (208) Other 729 — Deferred tax assets before valuation allowance 117,401 82,652 Valuation allowance (117,401) (82,652) Net deferred tax assets $ — $ — |
Schedule of Deferred Tax Assets | The difference between the income tax expense at the U.S. federal statutory rate and the recorded provision is primarily due to the valuation allowance provided on our net deferred tax assets. Our loss before income tax for the periods presented was generated primarily in the United States, with a small amount of income generated by our subsidiary in the United Kingdom. December 31, 2021 2020 U.S. federal tax statutory rate 21.0 % 21.0 % State taxes, net of federal benefit 6.5 % 6.8 % Non-deductible stock compensation (0.7) % (1.0) % Other non-deductible expenses (0.5) % (0.4) % Credits 1.8 % 1.8 % Change in valuation allowance (28.50) % (28.6) % Total (0.4) % (0.4) % December 31, 2021 2020 Deferred tax assets: Net operating loss carryforwards $ 51,653 $ 36,256 Research and development credits 9,879 7,092 Capitalized research and development, patent and start-up costs 47,511 34,452 Accrued expenses 1,219 1,370 Stock based compensation 6,262 3,443 Operating lease liability 2,660 3,186 Right of use asset – operating lease (2,434) (2,939) Depreciation (78) (208) Other 729 — Deferred tax assets before valuation allowance 117,401 82,652 Valuation allowance (117,401) (82,652) Net deferred tax assets $ — $ — |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Earnings Per Share [Abstract] | |
Schedule of Potentially Dilutive Securities Excluded from Computation of Diluted Weighted-Average Shares Outstanding | The following table presents securities that have been excluded from the computations of diluted weighted-average shares outstanding as they would be anti-dilutive: Year Ended December 31, 2021 2020 Unvested common stock from early exercise of options — 18,386 Stock options to purchase common stock 9,713,182 6,610,662 Warrant 139,770 — RSUs 320,209 284,000 Conversion option 375,940 — Common stock from the ESPP 13,152 24,508 Total 10,562,253 6,937,556 |
Organization and Basis of Pre_2
Organization and Basis of Presentation - Narrative (Details) - USD ($) | Aug. 23, 2021 | Feb. 02, 2021 | Jun. 03, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | Jan. 31, 2021 |
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||
Sale of stock, term (up to) | 3 years | 3 years | ||||
Cash and cash equivalents | $ 68,441,000 | $ 68,857,000 | ||||
Accumulated deficit | $ 414,695,000 | $ 292,519,000 | ||||
Registration Statement | ||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||
Maximum value of shares issued in transaction (up to) | $ 200,000,000 | $ 200,000,000 | ||||
Sale of stock, term (up to) | 3 years | |||||
At-the-market | ||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||
Maximum value of shares issued in transaction (up to) | $ 50,000,000 | |||||
Number of shares sold in public offering (in shares) | 139,734 | 1,232,131 | ||||
Gross proceeds from transaction | $ 1,800,000 | $ 6,800,000 | ||||
Net proceeds from transaction | $ 1,700,000 | $ 6,600,000 | ||||
At-the-market | Minimum | ||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||
Offering price per share (in dollars per share) | $ 12.54 | $ 4.25 | $ 12.54 | |||
At-the-market | Maximum | ||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||
Offering price per share (in dollars per share) | $ 13.17 | $ 11.15 | $ 13.17 | |||
Public Stock Offering | ||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||
Number of shares sold in public offering (in shares) | 5,175,000 | |||||
Offering price per share (in dollars per share) | $ 15 | |||||
Gross proceeds from transaction | $ 77,600,000 | |||||
Net proceeds from transaction | $ 72,700,000 | |||||
Over-allotment option | ||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||
Number of shares sold in public offering (in shares) | 675,000 | |||||
Private placement | ||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||
Offering price per share (in dollars per share) | $ 15 | |||||
Net proceeds from transaction | $ 7,500,000 |
Significant Accounting Polici_4
Significant Accounting Policies - Narrative (Details) $ in Millions | 12 Months Ended | |
Dec. 31, 2021USD ($)segment | Dec. 31, 2020USD ($) | |
Restricted Cash and Cash Equivalents Items [Line Items] | ||
Number of operating segments | segment | 1 | |
Other Assets | ||
Restricted Cash and Cash Equivalents Items [Line Items] | ||
Noncurrent restricted cash | $ 1.3 | $ 1.3 |
Prepaid Expenses and Other Current Assets | ||
Restricted Cash and Cash Equivalents Items [Line Items] | ||
Current restricted cash | $ 0.3 |
Significant Accounting Polici_5
Significant Accounting Policies - Reconciliation of Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Cash and cash equivalents: | |||
Cash | $ 1,452 | $ 4,487 | |
Money market funds | 66,989 | 64,370 | |
Total cash and cash equivalents | 68,441 | 68,857 | |
Restricted cash | 1,313 | 1,563 | |
Cash, cash equivalents and restricted cash | $ 69,754 | $ 70,420 | $ 79,333 |
Significant Accounting Polici_6
Significant Accounting Policies - Estimated Useful Lives of Property and Equipment (Details) | 12 Months Ended |
Dec. 31, 2021 | |
Computer hardware | Minimum | |
Property, Plant and Equipment [Line Items] | |
Useful life of property and equipment | 3 years |
Computer hardware | Maximum | |
Property, Plant and Equipment [Line Items] | |
Useful life of property and equipment | 5 years |
Computer software | |
Property, Plant and Equipment [Line Items] | |
Useful life of property and equipment | 3 years |
Furniture and fixtures | |
Property, Plant and Equipment [Line Items] | |
Useful life of property and equipment | 7 years |
Research and lab equipment, used | Minimum | |
Property, Plant and Equipment [Line Items] | |
Useful life of property and equipment | 3 years |
Research and lab equipment, new | Maximum | |
Property, Plant and Equipment [Line Items] | |
Useful life of property and equipment | 5 years |
ALJ Commercialization and Lic_2
ALJ Commercialization and License Agreement (Details) - ALJ - Transaction with party to collaborative arrangement - USD ($) $ in Millions | Mar. 17, 2021 | Dec. 31, 2021 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Negotiation period for second product candidate | 2 years | |
Maximum fee for second product option | $ 7.5 | |
Deferred revenue recognized | $ 7.5 | |
Share of operating profits and losses and development, regulatory and commercialization costs | 50.00% |
Leases - Narrative (Details)
Leases - Narrative (Details) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Jan. 31, 2018ft² | |
Leases [Abstract] | |||
Area of leased office and research development space (in square feet) | ft² | 40,765 | ||
Minimum rental payments received | $ 0.2 | ||
Rent expense | $ 3 | 2.9 | |
Sublease rental income | $ 0 | ||
Sublease rental income | $ 0.3 |
Leases - Minimum Aggregate Futu
Leases - Minimum Aggregate Future Lease Commitments (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Leases [Abstract] | |
2022 | $ 2,809 |
2023 | 3,154 |
2024 | 3,249 |
2025 | 2,492 |
Total lease payments | 11,704 |
Less imputed interest | (1,968) |
Total | 9,736 |
Other information: | |
Operating cash flows used for operating leases | $ 2,980 |
Weighted-average remaining lease term (in years) | 3 years 9 months |
Weighted-average discount rate | 9.50% |
Fair Value Measurements - Finan
Fair Value Measurements - Financial Assets and Liabilities Measured at Fair Value (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Assets: | ||
Total | $ 66,989 | $ 64,370 |
Money market funds included within cash and cash equivalents | ||
Assets: | ||
Cash and cash equivalents, fair value disclosure | 66,989 | 64,370 |
(Level 1) | ||
Assets: | ||
Total | 66,989 | 64,370 |
(Level 1) | Money market funds included within cash and cash equivalents | ||
Assets: | ||
Cash and cash equivalents, fair value disclosure | 66,989 | 64,370 |
(Level 2) | ||
Assets: | ||
Total | 0 | 0 |
(Level 2) | Money market funds included within cash and cash equivalents | ||
Assets: | ||
Cash and cash equivalents, fair value disclosure | 0 | 0 |
(Level 3) | ||
Assets: | ||
Total | 0 | 0 |
(Level 3) | Money market funds included within cash and cash equivalents | ||
Assets: | ||
Cash and cash equivalents, fair value disclosure | $ 0 | $ 0 |
Property and Equipment, Net - P
Property and Equipment, Net - Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Property and equipment: | ||
Property and equipment | $ 14,256 | $ 13,121 |
Less: accumulated depreciation | (7,634) | (5,643) |
Property and equipment, net | 6,622 | 7,478 |
Lab equipment | ||
Property and equipment: | ||
Property and equipment | 9,689 | 8,831 |
Leasehold improvements | ||
Property and equipment: | ||
Property and equipment | 2,157 | 2,157 |
Furniture and fixtures | ||
Property and equipment: | ||
Property and equipment | 809 | 822 |
Computers and software | ||
Property and equipment: | ||
Property and equipment | 259 | 230 |
Office equipment | ||
Property and equipment: | ||
Property and equipment | 21 | 3 |
Construction-in-process | ||
Property and equipment: | ||
Property and equipment | $ 1,321 | $ 1,078 |
Property and Equipment, Net - N
Property and Equipment, Net - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 2,216 | $ 2,026 |
Payables and Accruals (Details)
Payables and Accruals (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Payables and Accruals [Abstract] | ||
Accrued external research and development expenses | $ 4,895 | $ 9,394 |
Accrued payroll and related expenses | 6,412 | 5,620 |
Accrued professional fees | 1,013 | 604 |
Accrued other | 748 | 636 |
Total accrued expenses | $ 13,068 | $ 16,254 |
Loan and Security Agreement - N
Loan and Security Agreement - Narrative (Details) | Jul. 19, 2019USD ($)segment | Dec. 31, 2021USD ($)$ / shares | Dec. 31, 2020USD ($) | Jun. 16, 2021USD ($)$ / sharesshares |
Line of Credit Facility [Line Items] | ||||
Common stock exercise prices (in dollars per share) | $ / shares | $ 13.30 | |||
Anniversary of funding date for determining prepayment fee percentage | 18 months | |||
Additional paid in capital at its issuance date fair value | $ 1,800,000 | |||
Loss on extinguishment of debt | 3,226,000 | $ 0 | ||
Estimate of Fair Value Measurement | ||||
Line of Credit Facility [Line Items] | ||||
Credit facility estimate fair value | 46,600,000 | |||
2019 Credit Facility | ||||
Line of Credit Facility [Line Items] | ||||
Interest expense | 3,700,000 | $ 2,600,000 | ||
2019 Credit Facility | Line of Credit | ||||
Line of Credit Facility [Line Items] | ||||
Maximum borrowing capacity (up to) | $ 45,000,000 | |||
Number of tranches | segment | 3 | |||
Loan and security agreement, interest rate | 8.65% | |||
Prepayment fee percentage | 2.00% | |||
Prepayment fee percentage after specified period | 1.00% | |||
Fees incurred to establish facility | $ 400,000 | |||
Debt default interest rate per annum | 5.00% | |||
2019 Credit Facility | Line of Credit | Security and Loan Agreement, Tranche One | ||||
Line of Credit Facility [Line Items] | ||||
Maximum borrowing capacity (up to) | $ 20,000,000 | |||
2019 Credit Facility | Line of Credit | Security and Loan Agreement, Tranche Two | ||||
Line of Credit Facility [Line Items] | ||||
Maximum borrowing capacity (up to) | 10,000,000 | |||
2019 Credit Facility | Line of Credit | Security and Loan Agreement, Tranche Three | ||||
Line of Credit Facility [Line Items] | ||||
Maximum borrowing capacity (up to) | $ 15,000,000 | $ 15,000,000 | ||
2019 Credit Facility | Line of Credit | Security And Loan Agreement, Tranche Four | ||||
Line of Credit Facility [Line Items] | ||||
Maximum borrowing capacity (up to) | $ 15,000,000 | |||
2019 Credit Facility | Line of Credit | Prime Plus | ||||
Line of Credit Facility [Line Items] | ||||
Loan and security agreement, basis spread on interest rate | 3.15% | |||
Amended Credit Facility | Line of Credit | ||||
Line of Credit Facility [Line Items] | ||||
Number of shares called by warrants (in shares) (up to) | shares | 139,770 | |||
Common stock exercise prices (in dollars per share) | $ / shares | $ 13.30 | |||
Convertible debt (up to) | $ 5,000,000 | |||
Common stock at a conversion price (in dollars per share) | $ / shares | $ 13.30 | |||
Final payment under lease agreement as a percentage of loans borrowed | 4.80% | |||
Fees incurred to establish facility | $ 300,000 | |||
Loss on extinguishment of debt | $ 3,200,000 |
Loan and Security Agreement - S
Loan and Security Agreement - Significant Unobservable Inputs (level 3 Inputs) (Details) - (Level 3) - Fair Value, Recurring | Dec. 31, 2021 |
Expected volatility | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Debt instrument, measurement input | 0.7000 |
Expected yield | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Debt instrument, measurement input | 0.1150 |
Loan and Security Agreement - F
Loan and Security Agreement - Fair Value of Warrant (Details) | Dec. 31, 2021$ / shares |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Exercise price (in dollars per share) | $ 13.30 |
(Level 3) | Fair Value, Recurring | Fair value of underlying common stock | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Measurement input | 16.13 |
(Level 3) | Fair Value, Recurring | Risk-free interest rate | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Measurement input | 0.0156 |
(Level 3) | Fair Value, Recurring | Expected volatility | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Measurement input | 0.7000 |
(Level 3) | Fair Value, Recurring | Expected term (years) | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Measurement input | 10 |
(Level 3) | Fair Value, Recurring | Expected dividend yield | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Measurement input | 0 |
Loan and Security Agreement - M
Loan and Security Agreement - Minimum Aggregate Future Loan Payments (Details) - Line of Credit $ in Thousands | Dec. 31, 2021USD ($) |
Line of Credit Facility [Line Items] | |
2022 | $ 3,947 |
2023 | 17,404 |
2024 | 34,770 |
Total minimum payments | 56,121 |
Less amounts representing interest and discount | (9,564) |
Total Debt | $ 46,557 |
In-License Agreements - Narrati
In-License Agreements - Narrative (Details) - USD ($) | Dec. 31, 2021 | Aug. 06, 2017 | Mar. 10, 2016 |
Mayo Clinic | |||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||
Non-refundable upfront fee | $ 300,000 | ||
Milestone payments upon achievement of certain development, regulatory, and commercial events (up to) | $ 300,000 | ||
Amount due under license agreement | 0 | ||
Mayo Clinic | Maximum | |||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||
Milestone payments upon achievement of certain development, regulatory, and commercial events (up to) | $ 59,100,000 | ||
University of Chicago | |||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||
Milestone payments upon achievement of certain development, regulatory, and commercial events (up to) | $ 60,900,000 | ||
Amount due under license agreement | 0 | ||
Milestone payments for development and commercialization of licensed products | $ 400,000 | ||
University of Chicago | Maximum | |||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||
Non-refundable upfront fee | $ 500,000 |
Commitments and Contingencies -
Commitments and Contingencies - Narrative (Details) - Collaborative Arrangement - Sacco - EUR (€) | 1 Months Ended | 12 Months Ended |
Jul. 31, 2019 | Dec. 31, 2021 | |
Commitment And Contingencies [Line Items] | ||
Term of collaboration arrangement | 5 years | |
Period of inactive manufacturing services causing termination under collaborative agreement | 6 months | |
Aggregate amount due under collaborative arrangement | € 3,000,000 | |
Annual amount due under collaborative arrangement | € 600,000 | |
Fee incurred under collaborative arrangement | € 1,800,000 | |
Aggregate minimum amount | € 1,500,000 |
Stockholders_ Equity (Details)
Stockholders’ Equity (Details) - USD ($) | Aug. 23, 2021 | Feb. 02, 2021 | Jun. 03, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | Jun. 16, 2021 | Jan. 31, 2021 |
Subsidiary, Sale of Stock [Line Items] | |||||||
Sale of stock, term (up to) | 3 years | 3 years | |||||
Line of Credit | Amended Credit Facility | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Number of shares called by warrants (in shares) (up to) | 139,770 | ||||||
Common stock at a conversion price (in dollars per share) | $ 13.30 | ||||||
Convertible debt (up to) | $ 5,000,000 | ||||||
Registration Statement | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Maximum value of shares issued in transaction (up to) | $ 200,000,000 | $ 200,000,000 | |||||
Sale of stock, term (up to) | 3 years | ||||||
At-the-market | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Maximum value of shares issued in transaction (up to) | $ 50,000,000 | ||||||
Number of shares sold in public offering (in shares) | 139,734 | 1,232,131 | |||||
Net proceeds from issuance of common stock | $ 1,700,000 | $ 6,600,000 | |||||
Gross proceeds from transaction | $ 1,800,000 | $ 6,800,000 | |||||
At-the-market | Minimum | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Price of shares sold in public offering (in dollars per share) | $ 12.54 | $ 4.25 | $ 12.54 | ||||
At-the-market | Maximum | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Price of shares sold in public offering (in dollars per share) | $ 13.17 | $ 11.15 | $ 13.17 | ||||
Public Stock Offering | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Number of shares sold in public offering (in shares) | 5,175,000 | ||||||
Price of shares sold in public offering (in dollars per share) | $ 15 | ||||||
Net proceeds from issuance of common stock | $ 72,700,000 | ||||||
Gross proceeds from transaction | $ 77,600,000 | ||||||
Over-Allotment Option | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Number of shares sold in public offering (in shares) | 675,000 | ||||||
Private Placement | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Price of shares sold in public offering (in dollars per share) | $ 15 | ||||||
Net proceeds from issuance of common stock | $ 7,500,000 |
Stock-Based Compensation - Narr
Stock-Based Compensation - Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | Jan. 01, 2022 | Dec. 31, 2021 | May 27, 2021 | Jan. 01, 2021 | Jan. 01, 2019 | May 08, 2018 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2015 | Dec. 31, 2021 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Number of stock options granted (up to, in shares) | 3,501,949 | |||||||||
Number of options exercised (in shares) | 133,803 | |||||||||
Number of options canceled (in shares) | 265,626 | |||||||||
Unvested stock options outstanding (in shares) | 4,664,918 | 4,664,918 | 4,664,918 | |||||||
Weighted average fair value of options granted (in dollars per share) | $ 10.82 | $ 4.14 | ||||||||
Aggregate intrinsic value of options exercised | $ 900 | $ 900 | ||||||||
Compensation expense | $ 15,846 | $ 8,468 | ||||||||
Stock Option | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Expected dividend rate | 0.00% | |||||||||
Unrecognized stock based compensation expense, stock options | $ 36,500 | $ 36,500 | $ 36,500 | |||||||
Compensation cost not yet recognized, period for recognition | 2 years 7 months 13 days | |||||||||
Stock Option | Employee | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Expected dividend rate | 0.00% | 0.00% | ||||||||
Stock Option | Non-employee | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Expected dividend rate | 0.00% | 0.00% | ||||||||
RSUs | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Awards granted in period (in shares) | 172,450 | |||||||||
Compensation expense | $ 1,100 | |||||||||
RSUs | First anniversary | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
RSU vesting percentage | 25.00% | |||||||||
2021 Stock Inducement Plan | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Number of shares authorized for issuance (in shares) | 1,250,000 | |||||||||
Number of common stock available for future grant (in shares) | 445,455 | 445,455 | 445,455 | |||||||
2021 Stock Inducement Plan | Stock Option | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Vesting period | 4 years | |||||||||
Options granted, maximum expiration period (no more than) | 10 years | |||||||||
Number of stock options granted (up to, in shares) | 800,000 | |||||||||
2021 Stock Inducement Plan | RSUs | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Awards granted in period (in shares) | 4,545 | |||||||||
2018 Stock Incentive Plan | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Number of shares authorized for issuance (in shares) | 1,344,692 | |||||||||
Number of stock options granted (up to, in shares) | 7,078,131 | |||||||||
Number of common stock available for future grant (in shares) | 289,393 | 289,393 | 289,393 | |||||||
Percentage of outstanding shares | 4.00% | |||||||||
Additional shares authorized for issuance (in shares) | 1,898,805 | 1,286,824 | ||||||||
Number of options exercised (in shares) | 43,247 | |||||||||
Number of options canceled (in shares) | 1,110,384 | |||||||||
2018 Stock Incentive Plan | Subsequent Event | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Additional shares authorized for issuance (in shares) | 2,143,058 | |||||||||
2018 Stock Incentive Plan | Stock Option | Employee | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Vesting period | 4 years | |||||||||
2018 Stock Incentive Plan | Minimum | Stock Option | Non-employee | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Vesting period | 1 year | |||||||||
2018 Stock Incentive Plan | Maximum | Stock Option | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Options granted, maximum expiration period (no more than) | 10 years | |||||||||
2018 Stock Incentive Plan | Maximum | Stock Option | Non-employee | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Vesting period | 4 years | |||||||||
2015 Stock Incentive Plan | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Number of common stock available for future grant (in shares) | 5,417,044 | |||||||||
Number of shares, options and other equity awards granted (in shares) | 5,758,518 | |||||||||
Number of shares, options and other equity awards exercised (in shares) | 1,471,337 | |||||||||
Number of shares, options and other equity awards canceled (in shares) | 1,298,507 | |||||||||
Number of shares, options and other equity awards repurchased (in shares) | 18,468 | |||||||||
Number of shares no longer authorized (in shares) | 113,006 | |||||||||
2015 Stock Incentive Plan | Stock Option | Employee | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Vesting period | 4 years | |||||||||
2015 Stock Incentive Plan | Minimum | Stock Option | Non-employee | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Vesting period | 1 year | |||||||||
2015 Stock Incentive Plan | Maximum | Stock Option | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Options granted, maximum expiration period (no more than) | 10 years | |||||||||
2015 Stock Incentive Plan | Maximum | Stock Option | Non-employee | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Vesting period | 4 years | |||||||||
2018 Employee Stock Purchase Plan | Employee stock | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Percentage of outstanding shares | 1.00% | |||||||||
Additional shares authorized for issuance (in shares) | 336,356 | |||||||||
Compensation expense | $ 200 | $ 100 | ||||||||
Number of shares issued for purchase (in shares) | 46,358 | 28,603 | ||||||||
2018 Employee Stock Purchase Plan | Employee stock | Subsequent Event | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Additional shares authorized for issuance (in shares) | 535,765 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total stock-based compensation expense | $ 15,846 | $ 8,468 |
General and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total stock-based compensation expense | 7,842 | 3,981 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total stock-based compensation expense | $ 8,004 | $ 4,487 |
Stock-Based Compensation - St_2
Stock-Based Compensation - Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2021 | |
Shares | |
Options outstanding, beginning balance (in shares) | 6,610,662 |
Granted (in shares) | 3,501,949 |
Exercised (in shares) | (133,803) |
Canceled (in shares) | (265,626) |
Options outstanding, ending balance (in shares) | 9,713,182 |
Exercisable as of period end (in shares) | 5,048,264 |
Exercisable as of Vested and expected to vest (in shares) | 9,713,182 |
Weighted- Average Exercise Price | |
Options outstanding, beginning balance (in dollars per share) | $ 6.55 |
Granted (in dollars per share) | 14.58 |
Exercised (in dollars per share) | 5.65 |
Canceled (in dollars per share) | 11.14 |
Options outstanding, ending balance (in dollars per share) | 9.32 |
Exercisable at end of period (in dollars per share) | 6.67 |
Exercisable as of Vested and expected to vest (in dollars per share) | $ 9.32 |
Weighted Average - Remaining Contractual Life (years) | |
Options, outstanding, weighted average remaining contractual life | 7 years 3 months 14 days |
Options, exercisable, weighted average remaining contractual life | 6 years 2 months 15 days |
Options, vested and expected to vest, weighted average remaining contractual life | 7 years 3 months 14 days |
Options, outstanding, aggregate intrinsic value | $ 10,409 |
Options, exercisable, aggregate intrinsic value | 9,720 |
Options, vested and expected to vest, aggregate intrinsic value | $ 10,409 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Stock Option Valuation Assumptions (Details) - Stock Option | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected dividend rate | 0.00% | |
Employee | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 77.00% | 111.00% |
Expected life (in years) | 6 years 7 days | 6 years 18 days |
Volatility | 90.21% | 79.60% |
Expected dividend rate | 0.00% | 0.00% |
Non-employee | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 98.00% | 38.00% |
Expected life (in years) | 5 years 8 months 26 days | 5 years 2 months 15 days |
Volatility | 90.87% | 78.90% |
Expected dividend rate | 0.00% | 0.00% |
Stock-Based Compensation - Rest
Stock-Based Compensation - Restricted Stock Activity (Details) - RSUs | 12 Months Ended |
Dec. 31, 2021$ / sharesshares | |
Shares | |
Unvested beginning balance (in shares) | shares | 284,000 |
Granted (in shares) | shares | 172,450 |
Vested (in shares) | shares | (93,054) |
Forfeited (in shares) | shares | (43,187) |
Unvested ending balance (in shares) | shares | 320,209 |
Weighted- Average Exercise Price | |
Unvested beginning balance (in dollars per share) | $ / shares | $ 4.41 |
Granted (in dollars per share) | $ / shares | 15.50 |
Vested (in dollars per share) | $ / shares | 7.37 |
Forfeited (in dollars per share) | $ / shares | 7.98 |
Unvested ending balance (in dollars per share) | $ / shares | $ 9.04 |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Line Items] | ||
Provision for income taxes | $ 428,000 | $ 409,000 |
Percentage of income limitation on carryback provisions | 80.00% | |
Increase in valuation allowance | $ 34,700,000 | |
Unrecognized tax benefits | 0 | $ 0 |
Federal | ||
Income Tax Disclosure [Line Items] | ||
Net operating loss carryforwards | 189,700,000 | |
Net operating loss carryforwards subject to expiration | 49,900,000 | |
Net operating loss carried forward indefinitely | 139,700,000 | |
Research credit carryforwards | 7,200,000 | |
State | ||
Income Tax Disclosure [Line Items] | ||
Net operating loss carryforwards | 187,100,000 | |
Research credit carryforwards | $ 3,300,000 |
Income Taxes - Schedule of Effe
Income Taxes - Schedule of Effective Income Tax Rate Reconciliation (Details) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
U.S. federal tax statutory rate | 21.00% | 21.00% |
State taxes, net of federal benefit | 6.50% | 6.80% |
Non-deductible stock compensation | (0.70%) | (1.00%) |
Other non-deductible expenses | (0.50%) | (0.40%) |
Credits | 1.80% | 1.80% |
Change in valuation allowance | (28.50%) | (28.60%) |
Total | (0.40%) | (0.40%) |
Income Taxes - Schedule of Defe
Income Taxes - Schedule of Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 51,653 | $ 36,256 |
Research and development credits | 9,879 | 7,092 |
Capitalized research and development, patent and start-up costs | 47,511 | 34,452 |
Accrued expenses | 1,219 | 1,370 |
Stock based compensation | 6,262 | 3,443 |
Operating lease liability | 2,660 | 3,186 |
Right of use asset – operating lease | (2,434) | (2,939) |
Depreciation | (78) | (208) |
Other | 729 | 0 |
Deferred tax assets before valuation allowance | 117,401 | 82,652 |
Valuation allowance | (117,401) | (82,652) |
Net deferred tax assets | $ 0 | $ 0 |
Net Loss Per Share - Potentiall
Net Loss Per Share - Potentially Dilutive Securities Excluded from Computation of Diluted Weighted-Average Shares Outstanding (Details) - shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Securities excluded from the computation of diluted weighted-average shares outstanding (in shares) | 10,562,253 | 6,937,556 |
Unvested common stock from early exercise of options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Securities excluded from the computation of diluted weighted-average shares outstanding (in shares) | 0 | 18,386 |
Stock options to purchase common stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Securities excluded from the computation of diluted weighted-average shares outstanding (in shares) | 9,713,182 | 6,610,662 |
Warrant | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Securities excluded from the computation of diluted weighted-average shares outstanding (in shares) | 139,770 | 0 |
RSUs | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Securities excluded from the computation of diluted weighted-average shares outstanding (in shares) | 320,209 | 284,000 |
Conversion option | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Securities excluded from the computation of diluted weighted-average shares outstanding (in shares) | 375,940 | 0 |
Common stock from the ESPP | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Securities excluded from the computation of diluted weighted-average shares outstanding (in shares) | 13,152 | 24,508 |
Related Party Transactions - Na
Related Party Transactions - Narrative (Details) $ in Millions | Dec. 31, 2021installment | Apr. 09, 2021 | Oct. 15, 2020USD ($)installment | Oct. 11, 2020installmentshares | Sep. 16, 2019installmentshares | Dec. 31, 2021USD ($)shares | Dec. 31, 2020USD ($) | Jun. 30, 2021USD ($) |
Related Party Transaction [Line Items] | ||||||||
Number of options granted (in shares) | shares | 3,501,949 | |||||||
Weatherden Ltd | ||||||||
Related Party Transaction [Line Items] | ||||||||
Payment to related party | $ 0.3 | $ 0.6 | ||||||
Mr. Epstein | RSUs | ||||||||
Related Party Transaction [Line Items] | ||||||||
Aggregate grant date fair value for restricted stock units | $ 0.5 | |||||||
Consulting Agreement | Mr. Epstein | ||||||||
Related Party Transaction [Line Items] | ||||||||
Termination notice period of consulting arrangement | 30 days | |||||||
Termination notice period by non-breaching party in event of a breach | 24 hours | |||||||
Number of options granted (in shares) | shares | 44,743 | 75,000 | ||||||
Option to purchase shares, vesting period, number of equal monthly installments | installment | 36 | |||||||
Aggregate grant date fair value | $ 0.2 | |||||||
Annual equity award, vesting period, number of equal monthly installments | installment | 12 | 9 | ||||||
Aggregate annual cash consulting fee | $ 0.3 | |||||||
Renewal term | 1 year | |||||||
Consulting Agreement | Mr. Epstein | RSUs | ||||||||
Related Party Transaction [Line Items] | ||||||||
Option to purchase shares, vesting period, number of equal monthly installments | installment | 12 | |||||||
Period for trailing average closing common stock price | 10 days |
Defined Contribution Plan (Deta
Defined Contribution Plan (Details) - U.S. Plan - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Defined Contribution Plan Disclosure [Line Items] | ||
Defined contribution plan, employee deferral percentage | 85.00% | |
Defined contribution plan, matching contribution expense | $ 0.3 | $ 0.3 |