Cover
Cover - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 21, 2023 | Jun. 30, 2022 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2022 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 000-31141 | ||
Entity Registrant Name | INFINITY PHARMACEUTICALS, INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 33-0655706 | ||
Entity Address, Address Line One | 1100 Massachusetts Avenue | ||
Entity Address, Address Line Two | Floor 4 | ||
Entity Address, City or Town | Cambridge | ||
Entity Address, State or Province | MA | ||
Entity Address, Postal Zip Code | 02138 | ||
City Area Code | 617 | ||
Local Phone Number | 453-1000 | ||
Title of 12(b) Security | Common Stock, $0.001 par value | ||
Trading Symbol | INFI | ||
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 | false | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 54,976,690 | ||
Entity Common Stock, Shares Outstanding | 89,422,138 | ||
Documents Incorporated by Reference | None. | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0001113148 |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2022 | |
Audit 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, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 38,313 | $ 80,726 |
Prepaid expenses and other current assets | 1,989 | 1,542 |
Total current assets | 40,302 | 82,268 |
Property and equipment, net | 800 | 1,241 |
Restricted cash, less current portion | 158 | 158 |
Operating lease right-of-use assets | 697 | 1,064 |
Other assets | 194 | 54 |
Total assets | 42,151 | 84,785 |
Current liabilities: | ||
Accounts payable | 4,405 | 2,320 |
Accrued expenses and other current liabilities | 9,223 | 10,980 |
Total current liabilities | 13,628 | 13,300 |
Liabilities related to sale of future royalties, net, less current portion (Note 9) | 47,213 | 48,727 |
Operating lease liability, less current portion | 324 | 917 |
Other liabilities | 37 | 270 |
Total liabilities | 61,202 | 63,214 |
Commitments and contingencies | ||
Stockholders’ (deficit) equity: | ||
Preferred Stock, $0.001 par value; 1,000,000 shares authorized, no shares issued and outstanding at December 31, 2022 and 2021 | 0 | 0 |
Common Stock, $0.001 par value; 200,000,000 shares authorized; 89,411,471 and 89,155,311 shares issued and outstanding at December 31, 2022 and 2021, respectively | 89 | 89 |
Additional paid-in capital | 836,812 | 833,065 |
Accumulated deficit | (855,952) | (811,583) |
Total stockholders’ (deficit) equity | (19,051) | 21,571 |
Total liabilities and stockholders’ (deficit) equity | $ 42,151 | $ 84,785 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 1,000,000 | 1,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares 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) | 89,411,471 | 89,155,311 |
Common stock, shares, outstanding (in shares) | 89,411,471 | 89,155,311 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Revenue: | ||
Total revenues | $ 2,593 | $ 1,858 |
Operating expenses: | ||
Research and development | 32,411 | 31,647 |
General and administrative | 13,463 | 14,174 |
Royalty expense (Note 11) | 1,563 | 1,120 |
Total operating expenses | 47,437 | 46,941 |
Loss from operations | (44,844) | (45,083) |
Other income (expense): | ||
Investment and other income | 655 | 1 |
Non-cash interest expense (Note 9) | (180) | (180) |
Total other income (expense) | 475 | (179) |
Net loss | $ (44,369) | $ (45,262) |
Basic loss per common share (in dollars per share) | $ (0.50) | $ (0.53) |
Diluted loss per common share (in dollars per share) | $ (0.50) | $ (0.53) |
Basic weighted average number of common shares outstanding (in shares) | 89,247,785 | 85,597,264 |
Diluted weighted average number of common shares outstanding (in shares) | 89,247,785 | 85,597,264 |
Other comprehensive loss: | ||
Net unrealized holding gains on available-for-sale securities arising during the period | $ 0 | $ 1 |
Comprehensive loss | $ (44,369) | $ (45,261) |
Revenue, Product and Service | Royalty revenue |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating activities | ||
Net loss | $ (44,369) | $ (45,262) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 458 | 480 |
Stock-based compensation | 3,621 | 2,695 |
Non-cash royalty revenue | (1,373) | (984) |
Non-cash interest expense | 180 | 180 |
Other, net | 91 | 59 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | (587) | 171 |
Operating lease right-of-use asset | 367 | 355 |
Accounts payable, accrued expenses and other liabilities | (300) | 2,177 |
Operating lease liability | (519) | (489) |
Net cash used in operating activities | (42,431) | (40,618) |
Investing activities | ||
Purchases of property and equipment | (17) | (11) |
Purchases of available-for-sale securities | (16,038) | 0 |
Proceeds from maturities of available-for-sale securities | 16,000 | 5,500 |
Net cash (used in) provided by investing activities | (55) | 5,489 |
Financing activities | ||
Proceeds from public offering, net | 0 | 85,838 |
Proceeds from common stock sales facility, net of issuance costs | 0 | 336 |
Proceeds from issuances of common stock, net | 73 | 931 |
Net cash provided by financing activities | 73 | 87,105 |
Net (decrease) increase in cash, cash equivalents and restricted cash | (42,413) | 51,976 |
Cash, cash equivalents and restricted cash at beginning of period | 80,884 | 28,908 |
Cash, cash equivalents and restricted cash at end of period | 38,471 | 80,884 |
Reconciliation of cash, cash equivalents, and restricted cash to the consolidated balance sheets | ||
Cash and cash equivalents | 38,313 | 80,726 |
Restricted cash, less current portion | 158 | 158 |
Total cash, cash equivalents and restricted cash | $ 38,471 | $ 80,884 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' (Deficit) Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive (Loss) Income |
Beginning Balance (in shares) at Dec. 31, 2020 | 64,320,244 | ||||
Beginning Balance at Dec. 31, 2020 | $ (22,989) | $ 64 | $ 743,269 | $ (766,321) | $ (1) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Exercise of stock options (in shares) | 531,864 | ||||
Exercise of stock options | 860 | $ 1 | 859 | ||
Stock-based compensation expense | 2,695 | 2,695 | |||
Issuance of common stock related to public offering, net of issuance costs (in shares) | 24,150,000 | ||||
Issuance of common stock related to public offering, net of issuance costs | 85,838 | $ 24 | 85,814 | ||
Issuance of common stock related to sales facility, net of issuance costs (in shares) | 89,520 | ||||
Issuance of common stock related to sales facility, net of issuance costs | 336 | $ 0 | 336 | ||
Issuance of common stock, net (in shares) | 63,683 | ||||
Issuance of common stock, net | 92 | $ 0 | 92 | ||
Unrealized gain on marketable securities | 1 | 1 | |||
Net loss | $ (45,262) | (45,262) | |||
Ending Balance (in shares) at Dec. 31, 2021 | 89,155,311 | 89,155,311 | |||
Ending Balance at Dec. 31, 2021 | $ 21,571 | $ 89 | 833,065 | (811,583) | 0 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Exercise of stock options (in shares) | 17,708 | 17,708 | |||
Exercise of stock options | $ 15 | $ 0 | 15 | ||
Stock-based compensation expense | 3,621 | 3,621 | |||
Issuance of common stock, net (in shares) | 238,452 | ||||
Issuance of common stock, net | 111 | $ 0 | 111 | ||
Unrealized gain on marketable securities | 0 | ||||
Net loss | $ (44,369) | (44,369) | |||
Ending Balance (in shares) at Dec. 31, 2022 | 89,411,471 | 89,411,471 | |||
Ending Balance at Dec. 31, 2022 | $ (19,051) | $ 89 | $ 836,812 | $ (855,952) | $ 0 |
Organization
Organization | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | 1. Organization Infinity Pharmaceuticals, Inc., is a clinical-stage innovative biopharmaceutical company dedicated to developing novel medicines for people with cancer. As used throughout these audited, consolidated financial statements, the terms “Infinity,” “we,” “us,” and “our” refer to the business of Infinity Pharmaceuticals, Inc., and its wholly owned subsidiaries. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation These consolidated financial statements include the accounts of Infinity and its wholly-owned subsidiaries. We have eliminated all significant intercompany accounts and transactions in consolidation. The preparation of consolidated financial statements in accordance with generally accepted accounting principles requires our management to make estimates and judgments that may affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an ongoing basis, we evaluate our estimates and judgments. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results may differ from these estimates under different assumptions or conditions. Segment Information We operate in one business segment, which focuses on drug development. We make operating decisions based upon the performance of the enterprise as a whole and utilize our consolidated financial statements for decision making. Cash Equivalents and Available-For-Sale Securities Cash equivalents consist of money market funds. We consider all highly liquid investments with maturities of three months or less at the time of purchase to be cash equivalents. Cash equivalents are stated at fair value. They are also readily convertible to known amounts of cash and have such short-term maturities that each presents insignificant risk of change in value due to changes in interest rates. Our classification of cash equivalents is consistent with prior periods. From time to time we invest our cash in short-term marketable securities. We determine the appropriate classification of marketable securities at the time of purchase and re-evaluate such designation at each balance sheet date, if applicable. Typically, the marketable securities in which we invest have been classified as “available-for-sale.” We carry available-for-sale securities at fair value. Unrealized gains and losses on available-for-sale debt securities are reported in accumulated other comprehensive (loss) income, which is a separate component of stockholders’ equity. At various points during the years ended December 31, 2022 and 2021, we owned marketable securities that were classified as available-for-sale. We did not own any such securities as of December 31, 2022 or 2021. We adjust the cost of available-for-sale debt securities for amortization of premiums and accretion of discounts to maturity. We include such amortization and accretion in investment and other income. The cost of securities sold is based on the specific identification method. We include in investment income interest and dividends on securities classified as available-for-sale. We conduct periodic reviews to identify and evaluate each available-for-sale debt security that is in an unrealized loss position in order to determine whether an other-than-temporary impairment exists. An unrealized loss exists when the current fair value of an individual security is less than its amortized cost basis. For available-for-sale debt securities in an unrealized loss position, we perform an analysis to assess whether we intend to sell or whether we would more likely than not be required to sell the security before the expected recovery of the amortized cost basis. Where we intend to sell a security, or may be required to do so, the security’s decline in fair value is deemed to be other-than-temporary, and the full amount of the unrealized loss is recorded within earnings as an impairment loss. Unrealized losses on available-for-sale debt securities that are determined to be temporary, and not related to credit loss, are recorded, net of tax, in accumulated other comprehensive loss. Regardless of our intent to sell a security, we perform additional analysis on all securities in an unrealized loss position to evaluate losses associated with the creditworthiness of the security. Credit losses are identified where we do not expect to receive cash flows sufficient to recover the amortized cost basis of a security and are recorded within earnings as an impairment loss. Liquidity and Going Concern As of December 31, 2022, we had cash and cash equivalents of $38.3 million. We have primarily incurred operating losses since inception and have relied on our ability to fund our operations through collaboration and license arrangements, or other strategic arrangements, and through the sale of our common stock. We expect to continue to spend significant resources to fund the development and potential commercialization of eganelisib, also known as IPI-549, an orally administered immuno-oncology product candidate that selectively inhibits the enzyme phosphoinositide-3-kinase gamma, or PI3K-gamma, and to incur significant operating losses for the foreseeable future. As of December 31, 2022, we had an accumulated deficit of $856.0 million and during the year ended December 31, 2022 used $42.4 million in cash and cash equivalents to fund operating activities. We expect to continue to incur substantial operating losses and negative cash flows from operations for the foreseeable future. These conditions raise substantial doubt about our ability to continue as a going concern for at least twelve months from the date these consolidated financial statements are issued on March 28, 2023. If the Merger is not completed, we will need to raise additional capital in order to successfully execute on our current operating plans to further the development of eganelisib. If the Merger is not completed, we will explore other plans to mitigate the conditions which raise substantial doubt about our ability to continue as a going concern. We consider one of the following courses of action to be the most likely alternatives if the Merger is not completed: • Pursue another strategic transaction . We may resume the process of evaluating a potential strategic transaction, including the sale of the company or its assets. Based on our prior assessment, we do not expect that we would have the necessary time or financial resources to pursue another strategic transaction like the proposed Merger. • Wind down the company . If the Merger does not close and we are unable to enter into another strategic transaction, our board of directors may conclude that it is in the best interest of stockholders to cease normal operations and wind down the company through bankruptcy or dissolution proceedings. In such case, there would be no assurances as to the amount or timing of available cash remaining, if any, to distribute to stockholders after paying our obligations and setting aside funds for reserves. Our consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and settlement of liabilities and commitments in the ordinary course of business. The consolidated financial statements do not include any adjustments that might result from the outcome of the conditions described above. Concentration of Credit Risk Cash and cash equivalents are primarily maintained with two major financial institutions in the United States. Deposits at banks may exceed the insurance provided on such deposits. Generally, these deposits may be redeemed upon demand and, therefore, bear minimal risk. From time to time the Company invests its cash in other financial instruments that potentially subject us to concentration of credit risk, primarily consisting of available-for-sale securities. Our investment policy, which has been approved by our Board of Directors, limits the amount that we may invest in any one issuer of investments, thereby reducing credit risk concentrations. As of December 31, 2022 and 2021, the Company did not have any cash or cash equivalents invested in available-for-sale securities. Property and Equipment Property and equipment are stated at cost. Depreciation is recorded using the straight-line method over the estimated useful lives of the applicable assets. Application development costs incurred for computer software developed or obtained for internal use are capitalized. Upon sale or retirement, the cost and related accumulated depreciation are eliminated from the respective account, and the resulting gain or loss, if any, is included in current operations. Amortization of leasehold improvements, building improvements and finance leases is recorded as depreciation expense and included in research and development and general and administrative expense, as applicable. Repairs and maintenance charges that do not increase the useful life of the assets are charged to operations as incurred. Property and equipment are depreciated over the following periods: Computer equipment and software 3 to 5 years Leasehold improvements Shorter of lease term or useful life of asset Furniture and fixtures 7 to 10 years Impairment of Long-Lived Assets We evaluate our long-lived assets for potential impairment. Potential impairment is assessed when there is evidence that events or changes in circumstances have occurred that indicate that the carrying amount of a long-lived asset may not be recovered. Recoverability of these assets is assessed based on undiscounted expected future cash flows from the assets, considering a number of factors, including past operating results, budgets and economic projections, market trends and product development cycles. An impairment in the carrying value of each asset is assessed when the undiscounted expected future cash flows, including its eventual residual value, derived from the asset are less than its carrying value. Impairments, if any, are recognized in earnings. An impairment loss would be recognized in an amount equal to the excess of the carrying amount over the undiscounted expected future cash flows. Fair Value Measurements We define fair value as the price that we would receive to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. We determine fair value based on the assumptions market participants use when pricing the asset or liability. We use a valuation hierarchy for disclosure of the inputs used to measure fair value. This hierarchy prioritizes the inputs into three broad levels. Level 1 inputs, which we consider the highest level inputs, are quoted prices (unadjusted) in active markets for identical assets or liabilities. Level 2 inputs are quoted prices for similar assets and liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument. Level 3 inputs are unobservable inputs based on our own assumptions used to measure assets and liabilities at fair value. The classification of a financial asset or liability within the hierarchy is determined based on the lowest level input that is significant to the fair value measurement. Liabilities Related to Sale of Future Royalties We treat the liabilities related to sale of future royalties (see Note 9) as debt financings, amortized under the effective interest rate method over the estimated life of the related expected royalty stream. The liabilities related to sale of future royalties and the debt amortization are based on our current estimates of future royalties expected to be paid over the life of the arrangement. We will periodically assess the expected royalty payments using projections from external sources. To the extent our estimates of future royalty payments are greater or less than previous estimates or the estimated timing of such payments is materially different than previous estimates, we will adjust the effective interest rate and recognize related non-cash interest expense on a prospective basis. Non-cash royalty revenue is reflected as royalty revenue, and non-cash amortization of debt is reflected as non-cash interest expense in the Consolidated Statements of Operations and Comprehensive Loss. Leases We have entered into leases for office space and a data center. As of January 1, 2019, we adopted the provisions of Accounting Standards Codification, or ASC, Topic 842, Leases, or ASC 842. Accordingly, we recorded a right-of-use asset and a corresponding lease liability related to our leases. Rights and obligations related to our leases are included within operating lease right-of-use assets, accrued expenses and other current liabilities, and operating lease liability, less current portion in the Consolidated Balance Sheets. We recognize a right-of-use asset and a lease liability upon the commencement of a lease that has a term of more than twelve months. We combine lease and nonlease components for our leases. Lease payments included in determining the right-of-use asset and lease liability recognized include fixed payments to be paid over the term of the lease, less any lease incentives to be paid or payable to us by the lessor. Variable lease payments are included if they are based on an index or rate. Variable lease payments that are not based on an index or rate are recognized as expense in the period incurred. The lease term is determined at lease commencement, and includes the noncancellable period during which we have the right to use the underlying asset. Any period covered by an option to extend or terminate a lease is also included in the lease term if we are reasonably certain that the option to extend will be exercised or the option to terminate will not be exercised. Our leases do not provide an implicit rate; therefore, we use an estimate of our incremental borrowing rate based on the information available at the adoption date or lease commencement date in determining the present value of lease payments. Revenue Recognition To date, all our revenue has been generated under collaboration agreements, including payments to us of upfront license fees, funding or reimbursement of research and development efforts, milestone payments, if specified objectives are achieved, and royalties on product sales. We recognize revenue when we transfer goods or services to customers in an amount that reflects the consideration that we expect to receive for those goods or services. These principles are applied using a five-step model: 1) identify the customer contract; 2) identify the contract’s performance obligations; 3) determine the transaction price; 4) allocate the transaction price to the performance obligations; and 5) recognize revenue when or as a performance obligation is satisfied. We evaluate all promised goods and services within a customer contract and determine which of those are separate performance obligations. This evaluation includes an assessment of whether the good or service is capable of being distinct and whether the good or service is separable from other promises in the contract. When a performance obligation is satisfied, we recognize as revenue the amount of the transaction price, excluding estimates of variable consideration that are constrained, that is allocated to that performance obligation. For contracts that contain variable consideration, such as milestone payments, we estimate the amount of variable consideration by using either the expected value method or the most likely amount method. In making this assessment, we evaluate factors such as the clinical, regulatory, commercial and other risks that must be overcome to achieve the milestone. Each reporting period we re-evaluate the probability of achievement of such milestones and any related constraints. We will include variable consideration, without constraint, in the transaction price to the extent 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. We recognize sales-based milestones and royalty revenue based upon net sales by the licensee of licensed products in licensed territories, and in the period the sales occur under the sales- and usage-based royalty exception when the sole or predominate item to which the royalty relates is a license to intellectual property. In the event of an early termination of a collaboration agreement, any contract liabilities would be recognized in the period in which all our obligations under the agreement have been fulfilled. Research and Development Expense Research and development expense consists of expenses incurred in performing research and development activities, including salaries and benefits, overhead expenses including facilities expenses, materials and supplies, preclinical expenses, clinical trial and related clinical manufacturing expenses, comparator and combination drug expenses, stock-based compensation expense, depreciation of property and equipment, contract services, and other outside expenses. We also include as research and development expense upfront license payments related to acquired technologies which have not yet reached technological feasibility and have no alternative use. We expense research and development costs as they are incurred. Prepaid comparator and combination drug expenses are capitalized and then recognized as expense when title transfers to us. We have been a party to collaboration agreements in which we were reimbursed for work performed on behalf of the collaborator, as well as one in which we reimbursed the collaborator for work it had performed. We record all appropriate expenses under our collaborations as research and development expense. If the arrangement provides for reimbursement of research and development expenses incurred by us, we evaluate the terms of the arrangement to determine whether the reimbursement should be recorded as revenue or as an offset to research and development expense. If the arrangement provides for us to reimburse the collaborator for research and development expenses or for the achievement of a development milestone for which a payment is due, we record the reimbursement or the achievement of the development milestone as research and development expense. Stock-based Compensation Expense We issue stock-based awards to employees, directors, and non-employees, generally in the form of stock options, restricted stock units, or RSUs, or as awards under our 2013 Employee Stock Purchase Plan, or ESPP. We measure stock-based compensation cost at the grant date based on the estimated fair value of the award and recognize it as expense over the requisite service period on a straight-line basis. Stock-based compensation costs for non-employees are recognized as expense over the vesting period on a ratable basis. The grant date fair value of stock options and awards under our ESPP is measured using the Black-Scholes valuation model, which requires us to make assumptions about the fair value of our common stock on the date of grant. The grant date fair value of RSUs is estimated to be equal to the closing price of our common stock on the date of grant. For awards with performance conditions, we estimate the likelihood of satisfaction of the performance conditions, which affects the period over which the expense is recognized. When the likelihood of satisfying the performance conditions related to these awards is determined to be probable, we recognize the expense over the requisite service period. We have no awards with market conditions. We recognize forfeitures related to share-based payments as they occur. Royalty Expense Royalty expense is recorded when incurred and represents the expense associated with amounts owed to third parties as a result of royalty revenue recognized and the amounts owed by us to Takeda Pharmaceutical Company Limited, or Takeda, in relation to the sale of future royalties (see Note 11). Income Taxes We use the liability method to account for income taxes. Deferred tax assets and liabilities are determined based on differences between financial reporting and income tax basis of assets and liabilities, as well as net operating loss and tax credit carryforwards, and are measured using the enacted tax rates and laws that will be in effect when the differences reverse. Deferred tax assets are reduced by a valuation allowance to reflect the uncertainty associated with their ultimate realization. The effect of a change in tax rate on deferred taxes is recognized in income or loss in the period that includes the enactment date. We use our judgment for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. We recognize any material interest and penalties related to unrecognized tax benefits in income tax expense. Due to the uncertainty surrounding the realization of the net deferred tax assets in future periods, we have recorded a full valuation allowance against our otherwise recognizable net deferred tax assets as of December 31, 2022 and 2021. Basic and Diluted Net Loss per Common Share Basic net loss per share is based upon the weighted average number of common shares outstanding during the period, excluding restricted stock units that have been issued but have not yet vested. Diluted net loss per share is based upon the weighted average number of common shares outstanding during the period plus the effect of additional weighted average common equivalent shares outstanding during the period when the effect of adding such shares is dilutive. Common equivalent shares result from the assumed exercise of outstanding stock options and the exercise of outstanding warrants (the proceeds of which are then assumed to have been used to repurchase outstanding stock using the treasury stock method) and the vesting of restricted shares of common stock. In addition, the assumed proceeds under the treasury stock method include the average unrecognized compensation expense of stock options that are in-the-money. This results in the “assumed” buyback of additional shares, thereby reducing the dilutive impact of stock options. The two-class method is used for outstanding warrants as such warrants are considered to be participating securities, and this method is more dilutive than the treasury stock method. The following outstanding shares of common stock equivalents were excluded from the computation of net loss per share attributable to common stockholders for the periods presented because including them would have been antidilutive: At December 31, 2022 2021 Stock options 14,663,697 12,689,439 Non-vested restricted stock 2,939,816 50,000 Comprehensive Loss Comprehensive loss is comprised of net loss and other comprehensive loss. Other comprehensive loss is comprised of unrealized holding gains arising during the period on available-for-sale securities that are not other-than-temporarily impaired. During the year ended December 31, 2022, there were no material reclassifications out of accumulated other comprehensive (loss) income. New Accounting Pronouncements In June 2016, the Financial Accounting Standards Board, or FASB, issued Accounting Standard Update, or ASU, No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Statements , or ASU No. 2016-13, which requires that credit losses be reported using an expected losses model rather than the incurred losses model that is currently used, and it establishes additional disclosure requirements related to credit risks. For available-for-sale debt securities with expected credit losses, this standard now requires allowances to be recorded instead of reducing the amortized cost of the investment. In November 2019, the FASB subsequently issued ASU 2019-10, Financial Instruments—Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842): Effective Dates , whereby the effective date of this standard for smaller reporting companies was deferred to annual reporting periods beginning after December 15, 2022, including interim periods within those annual reporting periods, and early adoption is still permitted. We adopted this standard effective January 1, 2023 on a prospective basis. The adoption of this standard has not had a material impact on our consolidated financial statements and related disclosures. In August 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 , or ASU No. 2020-06, which simplifies the guidance on an issuer’s accounting for convertible instruments and contracts in its own equity. The provisions of ASU No. 2020-06 are applicable for fiscal years beginning after December 15, 2023, with early adoption permitted no earlier than fiscal years beginning after December 15, 2020. We are currently evaluating the impact of ASU No. 2020-06 on our consolidated financial statements and related disclosures. In November 2021, the FASB issued ASU No. 2021-10, Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance , or ASU No. 2021-10, which requires additional annual disclosures about transactions with a government that are accounted for by applying a grant or contribution accounting model by analogy. The additional disclosures required by this standard include 1) information about the nature of the transactions and the related accounting policy used to account for the transactions, 2) the financial statement line items that are impacted by the transactions and the amounts applicable to each financial statement line item and 3) significant terms and conditions of the transactions, including commitments and contingencies. We adopted this standard effective January 1, 2022 on a prospective basis. The adoption of the standard has not had a material impact on our consolidated financial statements. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | 3. Stock-Based Compensation Under each of the stock incentive plans described below, stock option awards made to new employees upon commencement of employment typically provide for vesting of 25% of the shares underlying the award at the end of the first year of service with the remaining 75% of the shares underlying the award vesting ratably on a monthly basis over the following three-year period subject to continued service. Annual grants to existing employees typically provide for ratable vesting over specified periods determined by the Board of Directors. In addition, under each plan, all options granted expire no later than ten years after the date of grant. 2019 Equity Incentive Plan Our 2019 Equity Incentive Plan, or the 2019 Plan, was approved by our stockholders in June 2019. The 2019 Plan provides for the grant of incentive stock options intended to qualify under Section 422 of the Internal Revenue Code of 1986, as amended, or IRC, as well as nonstatutory stock options, stock appreciation rights, restricted stock, restricted stock units and other stock-based and cash-based awards. Up to 12,531,009 shares of our common stock may be issued pursuant to awards granted under the 2019 Plan, plus an additional amount of our common stock underlying awards issued under the 2010 Stock Incentive Plan, or the 2010 Plan, that expire or are canceled without the holders receiving any shares under those awards. As of December 31, 2022, an aggregate of 7,744,676 shares of our common stock were reserved for issuance upon the vesting or exercise of outstanding awards, and up to 2,564,077 shares of common stock may be issued pursuant to awards granted under the 2019 Plan. 2010 Stock Incentive Plan The 2010 Plan provided for the grant of incentive stock options under the IRC, as well as nonstatutory stock options, stock appreciation rights, restricted stock, restricted stock units and other stock-based and cash-based awards. As of December 31, 2022, an aggregate of 6,309,021 shares of our common stock were reserved for issuance upon the exercise of outstanding awards granted under the 2010 Plan. The 2010 Plan was terminated upon approval of the 2019 Plan; therefore, no further grants may be made under the 2010 Plan. 2013 Employee Stock Purchase Plan Our ESPP permits eligible employees to purchase shares of our common stock at a discount and consists of consecutive, overlapping 24-month offering periods, each consisting of four six-month purchase periods. On the first day of each offering period, each employee who is enrolled in the ESPP will automatically receive an option to purchase up to a whole number of shares of our common stock. The purchase price of each of the shares purchased, in a given purchase period, will be equal to 85% of the closing price of a share of our common stock, on the first day of the offering period or the last day of the purchase period, whichever is lower. During the year ended December 31, 2022, 111,155 shares of common stock were purchased for total proceeds of approximately $0.1 million. During the year ended December 31, 2021, 57,561 shares of common stock were purchased for total proceeds of approximately $0.1 million. Compensation Expense Total stock-based compensation expense related to all equity awards was comprised of the following: Year Ended December 31, 2022 2021 (in thousands) Research and development $ 1,291 $ 830 General and administrative 2,330 1,865 Total stock-based compensation expense $ 3,621 $ 2,695 As of December 31, 2022, we had approximately $8.1 million of total unrecognized compensation cost related to unvested common stock options, restricted stock units and awards under our ESPP, which are expected to be recognized over a weighted-average period of two years. Stock Options We estimate the fair value of stock options at the date of grant using the Black-Scholes valuation model with the following weighted-average assumptions: December 31, 2022 2021 Risk-free interest rate 2.1 % 0.9 % Expected annual dividend yield — — Expected stock price volatility 105.0 % 106.3 % Expected term of options 5.9 years 5.9 years The valuation assumptions were determined as follows: • Risk-free interest rate: The yield on zero-coupon U.S. Treasury securities for a period that was commensurate with the expected term of the awards. • Expected annual dividend yield: The estimate for annual dividends was zero because we have not historically paid a dividend and do not intend to do so in the foreseeable future. • Expected stock price volatility: We determined the expected volatility by using our available implied and historical price information. • Expected term of options: The expected term of the awards represents the period of time that the awards were expected to be outstanding. We use the simplified method to estimate expected term as we do not have sufficient historical exercise data to provide a reasonable basis on which to estimate the expected term. Under this method, the expected life equals the average of the vesting term and the original contractual term of the option. A summary of our stock option activity for the year ended December 31, 2022 is as follows: Stock Options Weighted-Average Weighted-Average Aggregate Outstanding at January 1, 2022 12,689,439 $ 3.53 Granted 2,886,324 1.36 Exercised (17,708) 0.83 Forfeited (238,129) 1.46 Expired (656,229) 8.30 Outstanding at December 31, 2022 14,663,697 $ 2.93 6.3 $ — Exercisable at December 31, 2022 10,903,188 $ 3.33 5.6 $ — The weighted-average fair value per share of options granted during the years ended December 31, 2022 and 2021 was $1.10 and $2.69, respectively. The aggregate intrinsic value of options outstanding at December 31, 2022 was calculated based on the positive difference, if any, between the closing fair market value of our common stock on December 31, 2022 and the exercise price of the underlying options. The aggregate intrinsic value of options exercised during the year ended December 31, 2022 was nominal. The aggregate intrinsic value of options exercised during the year ended December 31, 2021 was $0.8 million. No related income tax benefits were recorded during the years ended December 31, 2022 or 2021. We settle employee stock option exercises with newly issued shares of our common stock. Restricted Stock Units A summary of our RSU activity for the year ended December 31, 2022 is as follows: Restricted Stock Units Weighted-Average Outstanding, non-vested at January 1, 2022 50,000 $ 2.93 Granted 2,950,483 1.08 Vested (50,000) 2.93 Forfeited (10,667) 1.08 Outstanding, non-vested at December 31, 2022 2,939,816 $ 1.08 |
Cash, Cash Equivalents and Avai
Cash, Cash Equivalents and Available-for-Sale Securities | 12 Months Ended |
Dec. 31, 2022 | |
Cash and Cash Equivalents [Abstract] | |
Cash, Cash Equivalents and Available-for-Sale Securities | 4. Cash, Cash Equivalents and Available-for-Sale Securities As of December 31, 2022 and 2021, we had cash and cash equivalents of $38.3 million and $80.7 million, respectively. We have not incurred any unrealized gains or losses on our cash and cash equivalents balances as of December 31, 2022 and 2021. |
Fair Value
Fair Value | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value | 5. Fair Value We measure certain financial instruments at fair value on a recurring basis. The Company’s assets which are required to be measured on a recurring basis consist of cash and cash equivalents totaling $38.3 million and $80.7 million as of December 31, 2022 and 2021, respectively. The Company’s liabilities which are required to be measured on a recurring basis consist of a warrant liability in the amount of $0.2 million as of December 31, 2022 and 2021. Cash and cash equivalents, which are measured using Level 1 inputs, consist of highly liquid deposit accounts and money market funds that are intended to consistently transact at a target net asset value of $1.00. Accordingly, the carrying amounts reflected in the condensed consolidated balance sheets for cash and cash equivalents approximate their fair value. Warrant liability relates to potential future warrants that may be issued. The fair value of the warrant liability on the date of the commitment and on each re-measurement date for those warrants classified as liabilities was estimated using the Monte Carlo simulation model, which involves a series of simulated future stock price paths over the remaining life of the commitment. The fair value is estimated by taking the average of the fair values under each of many Monte Carlo simulations. The fair value estimate is affected by our stock price, as well as estimated future financing needs, including timing and sources of the financing and subjective variables including expected stock price volatility over the remaining life of the commitment and risk-free interest rate. Due to the nature of these inputs, the valuation of the warrants is considered a Level 3 measurement. The fair value of the warrant liability as of December 31, 2022 has been included in accrued expenses and other current liabilities on our consolidated balance sheet. The fair value of the warrant liability as of December 31, 2021 has been included in other liabilities on our consolidated balance sheet. See Note 9 for further discussions of the accounting for the warrants. There have been no changes to our valuation methods during the year ended December 31, 2022. We had no available-for-sale securities that were classified as Level 3 at any point during the year ended December 31, 2022. The carrying amounts reflected in the consolidated balance sheets for prepaid expenses and other current assets, other assets, accounts payable and accrued expenses and other current liabilities approximate their fair value due to their short-term maturities. |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 12 Months Ended |
Dec. 31, 2022 | |
Prepaid Expense and Other Assets, Current [Abstract] | |
Prepaid Expenses and Other Current Assets | 6. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consist of the following: December 31, 2022 2021 (in thousands) Prepaid expenses $ 1,429 $ 1,143 Other current assets 560 399 Total prepaid expenses and other current assets $ 1,989 $ 1,542 |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | 7. Property and Equipment Property and equipment consist of the following: December 31, 2022 2021 (in thousands) Computer equipment and software $ 1,921 $ 1,904 Furniture and fixtures 446 446 Leasehold improvements 1,743 1,743 4,110 4,093 Less accumulated depreciation (3,310) (2,852) $ 800 $ 1,241 |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 12 Months Ended |
Dec. 31, 2022 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | 8. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following: December 31, 2022 2021 (in thousands) Accrued clinical $ 4,290 $ 4,998 Accrued professional services 785 88 Accrued consulting 742 475 Accrued compensation and benefits 605 2,835 Accrued development 335 755 Liability related to sale of future royalties, net, current portion 1,218 897 Operating lease liability, current portion 593 519 Other 655 413 Total accrued expenses $ 9,223 $ 10,980 |
Liabilities Related to Sale of
Liabilities Related to Sale of Future Royalties | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Liabilities Related to Sale of Future Royalties | 9. Liabilities Related to Sale of Future Royalties HCR Agreement In 2016, we and Verastem Inc., or Verastem, entered into an amended and restated license agreement, or the Verastem Agreement, under which we granted to Verastem an exclusive worldwide license in oncology indications for the research, development, commercialization, and manufacture of duvelisib, or Copiktra ® , an oral, dual inhibitor of PI3K delta and gamma, and products containing duvelisib, which we refer to as Licensed Products. In September 2020, Verastem completed a disposition of its rights, title, and interest in and to duvelisib to Secura Bio, Inc., or Secura Bio, whereby Secura Bio assumed all liabilities and obligations under the Verastem Agreement. We now refer to the Verastem Agreement as the Secura Bio Agreement. Secura Bio is obligated to pay us royalties on worldwide net sales of Licensed Products ranging from the mid-single digits to the high-single digits, a portion of which we are obligated to share with Takeda Pharmaceuticals Company Limited, or Takeda, as described in Note 11. In March 2019, we entered into a royalty purchase agreement, or the HCR Agreement, with HealthCare Royalty Partners III, L.P., or HCR, providing for the acquisition by HCR of our interest in certain royalty payments based on worldwide annual net sales of Licensed Products under the Secura Bio Agreement for gross proceeds of $30.0 million, which is non-refundable. After sharing with Takeda in accordance with the Takeda Amendment, as defined in Note 11, we retained $22.5 million in gross proceeds, or approximately $20.9 million in net proceeds. Under the HCR Agreement, HCR obtained the right to receive the royalty payments up to agreed upon thresholds of royalties, the amount of which depends on when the aggregate royalties received by HCR reach specified thresholds. If the specified threshold has been met through royalty payments from Secura Bio or if we elect to make a payment to meet the threshold amount, the HCR Agreement will automatically terminate and all rights to the royalty stream under the HCR Agreement will revert back to us. If the specified threshold has not been achieved by June 30, 2025, the HCR Agreement will continue through the term of the Secura Bio Agreement. We recognized the receipt of the $30.0 million payment from HCR as a liability, net of debt discount and issuance costs of approximately $2.4 million. As the basis for our determination, we considered, in accordance with the relevant accounting guidance, the potential for the royalty stream to revert back to us if specified royalty thresholds have been met and our right to terminate the HCR Agreement by making a payment to achieve the threshold. We are not obligated to repay any of the proceeds received under the HCR Agreement. In order to determine the amortization of the liability, we are required to estimate the total amount of future net royalty payments to be made to HCR over the term of the HCR Agreement. The total threshold of net royalties to be paid, less the net proceeds received, will be recorded as interest expense over the life of the liability. We impute interest on the unamortized portion of the liability using the effective interest method. Interest and debt discount amortization expense is reflected as non-cash interest expense in the Consolidated Statements of Operations and Comprehensive Loss. Over the course of the HCR Agreement, the actual interest rate will be affected by the amount and timing of royalty revenue recognized and changes in forecasted royalty revenue. On a quarterly basis, we reassess the effective interest rate and adjust the rate prospectively as needed. The following table shows the activity within the liability account for the years ended December 31, 2022 and 2021: December 31, 2022 2021 (in thousands) Liability related to sale of future royalties - beginning balance $ 28,038 $ 28,869 Non-cash royalty revenue (1,373) (984) Non-cash interest expense recognized 153 153 Liability related to sale of future royalties, net - ending balance $ 26,818 $ 28,038 Less: current portion (1,218) (897) Liability related to sale of future royalties, net, less current portion $ 25,600 $ 27,141 As royalties are due to HCR by Secura Bio, the balance of the recognized liability will be effectively repaid over the life of the HCR Agreement. There are a number of factors that could materially affect the amount and timing of royalty payments from Secura Bio, none of which are within our control. BVF Agreement On January 8, 2020, or the BVF Closing Date, we entered into a funding agreement, or the BVF Funding Agreement, with BVF Partners, L.P., or BVF, and Royalty Security, LLC, a wholly-owned subsidiary of BVF, or the Buyer. BVF was subsequently replaced as a party to the BVF Funding Agreement with Royalty Security Holdings, LLC. The BVF Funding Agreement provides for the acquisition by the Buyer of our interest in all royalty payments based on worldwide annual net sales of a clinical-stage product candidate IPI-926, or patidegib, part of the hedgehog inhibitor program we licensed to PellePharm Inc., or PellePharm, in 2013, or the BVF Licensed Product, excluding relevant Trailing Mundipharma Royalties, as defined in Note 11, which is related to patidegib. We refer to all BVF Licensed Product royalties owed to us less Trailing Mundipharma Royalties as the Royalty or Royalties. In January 2023, PellePharm announced that Sol-Gel Technologies, Ltd., or Sol-Gel, acquired all rights and obligations under the license agreement. We now refer to the license agreement with PellePharm as the Sol-Gel Agreement. Such Royalties are owed to us pursuant to the Sol-Gel Agreement, as further described in Note 11. Pursuant to the BVF Funding Agreement, we received a non-refundable payment of $20.0 million, or the Upfront Purchase Price, less certain transaction expenses. We transferred to the Buyer (i) the Royalty, (ii) the Sol-Gel Agreement (subject to our rights to milestone payments and rights to equity in Sol-Gel under the Sol-Gel Agreement), and (iii) certain patent rights established in the BVF Funding Agreement, with (i), (ii), and (iii) together referred to as Transferred Assets. We preserved our rights under the Sol-Gel Agreement to receive potential regulatory, commercial, and success-based milestone payments. We have the option to terminate the BVF Funding Agreement by purchasing 100% of the outstanding equity interests of the Buyer under specified terms for a specified amount under the BVF Funding Agreement through January 8, 2023. In addition, the BVF Funding Agreement may be terminated by mutual written agreement between us and the Buyer. We recognized the proceeds received under the BVF Funding Agreement as a liability that will be amortized using the effective interest method over the life of the arrangement. We recorded the receipt of the $20.0 million Upfront Purchase Price as a liability, net of debt issuance costs of approximately $0.4 million and warrant liability of $0.3 million. We are not obligated to repay any of the proceeds received under the BVF Funding Agreement. In order to determine the amortization of the liability, we are required to estimate the total amount of potential future net royalty payments to be made by Sol-Gel to the Buyer over the term of the BVF Funding Agreement. The total estimated net royalties to be paid, less the net proceeds received, will be recorded as interest expense over the life of the liability. Interest and debt discount amortization expense is reflected as non-cash interest expense for the years ended December 31, 2022 and 2021 in our consolidated statements of operations and comprehensive loss. Over the course of the BVF Funding Agreement, the actual interest rate will be affected by the amount and timing of royalty revenue recognized, if any, and changes in forecasted royalty revenue. There are a number of factors that could materially affect the amount and timing of royalty payments from Sol-Gel, none of which are within our control. On a quarterly basis, we will reassess the effective interest rate and adjust the rate prospectively as needed. The following table shows the activity within the liability account for the years ended December 31, 2022 and 2021: December 31, 2022 2021 (in thousands) Liability related to sale of future royalties - beginning balance $ 21,586 $ 21,559 Non-cash interest expense recognized 27 27 Liability related to sale of future royalties, net - ending balance $ 21,613 $ 21,586 For so long as we have not exercised an option to repurchase the Buyer’s equity interest under the BVF Funding Agreement, (a) if, during the 36-month period following the BVF Closing Date, we issue a specified number of shares of our common stock, which we refer to as the Warrant Threshold, and (b) any shares in excess of the Warrant Threshold are issued for consideration to us of less than $3.75 per share (as adjusted for any stock splits, reverse stock splits or other similar recapitalization events), or the Threshold Price, then we are obligated to issue to BVF warrants to purchase a number of shares of our common stock. Such warrants would equal 50% of the number of qualifying shares at an exercise price equal to 1.5 times the price per share of such qualifying shares issued. The requirement to issue warrants to BVF does not apply to certain issuances of our common stock. As of December 31, 2022, the Warrant Threshold has been met and any future qualifying shares of our common stock issued below the Price Threshold will result in warrants to purchase our common stock to be issued to BVF. No warrants have been issued to BVF as of December 31, 2022. Our obligation to issue warrants to BVF under these terms expired on January 8, 2023 without any warrants being issued to BVF. We determined that the commitment to issue warrants represents a freestanding financial instrument and accounted for it as a liability as of the BVF Closing Date. The fair value of the warrant liability was estimated using the Monte Carlo simulation model. The fair value of the warrant liability as of December 31, 2022 has been included in accrued expenses and other current liabilities on our consolidated balance sheet. The fair value of the warrant liability as of December 31, 2021 has been included in other liabilities on our consolidated balance sheet. Changes in fair value of the warrant liability are included in investment and other income (expense) in our consolidated statements of operations and comprehensive loss. See Note 5 for further discussions of the fair value of the warrants. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 10. Commitments and Contingencies On April 5, 2019, we entered into a lease agreement, or the Lease, with Sun Life Assurance Company of Canada, or the Landlord, effective April 3, 2019, or the Commencement Date, for the lease of approximately 10,097 square feet of office space at 1100 Massachusetts Avenue, Cambridge, Massachusetts, or the Leased Premises. The term of the Lease commenced on the Commencement Date and expires on August 1, 2024, or the Expiration Date, approximately five years after the Rent Commencement Date as defined below. Beginning August 1, 2019, or the Rent Commencement Date, the total base rent of the Lease was $47,961 per month and increases by approximately 3% on each anniversary of the Rent Commencement Date until the Expiration Date. In addition to the base rent, we are also responsible for our share of the operating expenses, insurance, real estate taxes and certain capital costs, and we are responsible for utility expenses in the Leased Premises, all in accordance with the terms of the Lease. Pursuant to the terms of the Lease, we provided a security deposit in the form of a letter of credit in the initial amount of $300,000, which was reduced to $150,000 during the year ended December 31, 2021 in accordance with the terms of the Lease. The remaining portion of the security deposit plus the associated bank fee of $7,500 is included in our consolidated balance sheet as restricted cash as of December 31, 2022 and 2021. The Landlord provided a lease incentive allowance of $0.6 million to fund certain improvements to be made by us to the Leased Premises. Subject to certain conditions specified in the Lease, we have the right to extend the term of the Lease for two years, if we provide notice to the Landlord not earlier than twelve months, nor later than nine months, prior to expiration of the Lease. The base rent for the extension term shall be equal to the greater of the base rent in effect for the last year of the initial lease term or a fair market base rent determined according to the terms of the Lease. The Lease contains customary provisions allowing the Landlord to, among other things, accelerate payments under the Lease or terminate the Lease in its entirety if we fail to remedy a default of any of our obligations under the Lease within specified time periods or upon our bankruptcy or insolvency. We have recorded a right-of-use asset and lease liability related to our data center lease and the Lease. The lease of our data center expired during the year ended December 31, 2021. The following is a summary of our current lease included in the respective balance sheet classifications: December 31, 2022 2021 Assets (in thousands) Operating lease right-of-use assets $ 697 $ 1,064 Liabilities Accrued expenses and other current liabilities $ 593 $ 519 Operating lease liability 324 917 Total lease liabilities $ 917 $ 1,436 As of December 31, 2022, the weighted average term remaining on our lease is 1.6 years, and the weighted average discount rate is 10%. As of December 31, 2021, the weighted average term remaining on our lease was 2.6 years, and the weighted average discount rate was 10%. Operating lease costs, including variable costs, of $0.7 million were incurred during both the years ended December 31, 2022 and 2021. Cash paid for amounts included in the measurement of lease liabilities were $0.6 million and $0.7 million during the years ended December 31, 2022 and 2021, respectively. As of December 31, 2022, future minimum lease payments of our operating lease liabilities are as follows: Operating Leases (in thousands) 2023 $ 658 2024 334 Total future minimum lease payments 992 Less: imputed interest (75) Total lease liability $ 917 |
Strategic Agreements
Strategic Agreements | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Strategic Agreements | 11. Strategic Agreements We have worldwide development and commercialization rights to eganelisib, subject to certain obligations to our licensor, Takeda Pharmaceutical Company Limited, or Takeda, as described in more detail below. Additionally, we are obligated to pay Mundipharma International Corporation Limited, or Mundipharma, and Purdue Pharmaceutical Products L.P., or Purdue, a 4% royalty in the aggregate on worldwide net sales of products that were previously subject to our strategic alliance with Mundipharma and Purdue that was terminated in 2012. Such products include eganelisib; duvelisib, the PI3K delta and gamma inhibitor that we licensed to Verastem in 2016, the rights to which Verastem sold to Secura Bio in 2020; and IPI-926, or patidegib, part of the hedgehog inhibitor program we licensed to PellePharm in 2013, and which license is now held by Sol-Gel. We refer to such royalties as Trailing Mundipharma Royalties. After Mundipharma and Purdue have recovered approximately $260.0 million in royalty payments from all products that were previously subject to the strategic alliance, which represents the funding paid to us for research and development services performed by us under this strategic alliance, the Trailing Mundipharma Royalties will be reduced to a 1% royalty on net sales in the United States of such products. As of December 31, 2022, Mundipharma and Purdue have recovered $3.5 million. PellePharm / Sol-Gel Technologies In June 2013, we entered into a license agreement with PellePharm, under which we granted PellePharm exclusive global development and commercialization rights to our hedgehog inhibitor program, including patidegib. In January 2023, PellePharm announced that Sol-Gel acquired all rights and obligations under the license agreement. We refer to our license agreement with PellePharm as the Sol-Gel Agreement and products covered by the Sol-Gel Agreement as Hedgehog Products. We assessed this arrangement in accordance with ASC 606 and concluded that at the date of contract inception there was only one performance obligation, consisting of the license, which was satisfied at contract inception. Under the Sol-Gel Agreement, Sol-Gel is obligated to pay us up to $9.0 million in remaining regulatory and commercial-based milestone payments through the first commercial sale of a Hedgehog Product. Sol-Gel is also obligated to pay us up to $37.5 million in success-based milestone payments upon the achievement of certain annual net sales thresholds, as well as a share of certain revenue received by Sol-Gel in the event that Sol-Gel sublicenses its rights under the Sol-Gel Agreement and tiered royalties on annual net sales of Hedgehog Products subject to specified conditions. The remaining milestones have not been recognized as they represent variable consideration that is constrained. In making this assessment, we considered numerous factors, including the fact that achievement of the milestones is outside of our control and contingent upon the future success of clinical trials, Sol-Gel’s actions, and the receipt of regulatory approval. As the single performance obligation was previously satisfied, all regulatory and commercial-based milestones will be recognized as revenue in full in the period in which the constraint is removed. Any consideration related to sales-based milestone payments, including royalties, will be recognized when the related sales occur as these amounts have been determined to relate predominantly to the license granted to Sol-Gel and therefore are recognized at the later of when the performance obligation is satisfied, or the related sales occur. Sol-Gel is also obligated to pay us tiered royalties on annual net sales of Hedgehog Products, which are subject to reduction after a certain aggregate funding threshold has been achieved. On January 8, 2020, we entered into the BVF Funding Agreement, as further described in Note 9, pursuant to which we sold our interest in all royalty payments based on worldwide annual net sales of the BVF Licensed Product, excluding Trailing Mundipharma Royalties related to patidegib. Takeda In July 2010, we entered into a development and license agreement with Intellikine, Inc., or Intellikine, under which we obtained rights to discover, develop and commercialize pharmaceutical products targeting the gamma and/or delta isoforms of PI3K, including eganelisib and duvelisib. In January 2012, Intellikine was acquired by Takeda. In December 2012, we amended and restated our development and license agreement with Takeda and further amended the agreement in July 2014, September 2016, July 2017, and March 2019. We refer to the amended and restated development and license agreement, as amended, as the Takeda Agreement. Duvelisib Pursuant to the Takeda Agreement, prior to March 4, 2019, we were obligated to share equally with Takeda all revenue arising from certain qualifying transactions for duvelisib, including the Secura Bio Agreement, subject to certain exceptions including revenue we receive as reimbursement for duvelisib research and development expenses. On March 4, 2019, we entered into the fourth amendment to the Takeda Agreement, or the Takeda Amendment. Pursuant to the Takeda Amendment, Takeda agreed (i) to the sale of certain royalty payments based on worldwide annual net sales of Licensed Products under the Secura Bio Agreement to HCR, (ii) to forego its rights to an equal share of the royalties due from Secura Bio during the term of the HCR Agreement, and (iii) not to seek any payment from HCR with respect to the royalties owed to Takeda. As consideration for the Takeda Amendment, we paid Takeda $6.7 million representing 25% of the $30.0 million in gross proceeds we received from the closing of the HCR Agreement, net of 25% of the expenses incurred by us in connection with the HCR Agreement. In addition, we agreed to pay Takeda 25% of the royalties that would have been payable to us by Secura Bio but for the consummation of the HCR Agreement, which we refer to as the Interim Obligation. During the years ended December 31, 2022 and 2021, we recognized $0.3 million and $0.2 million, respectively, of Interim Obligation amounts owed to Takeda as royalty expense. We have the right to extinguish the Interim Obligation by payment to Takeda of an amount equal to (i) the $6.7 million payment multiplied by the multiple set forth in the table below corresponding to the time period in which such extinguishing payment is made, minus (ii) any payments made to Takeda pursuant to the Interim Obligation: Time Period Multiple From the Takeda Amendment Effective Date until June 30, 2022 145 % From July 1, 2022 through June 30, 2023 155 % From July 1, 2023 through June 30, 2024 165 % From July 1, 2024 through June 30, 2025 175 % The Interim Obligation shall expire upon the termination of the HCR Agreement and the reversion of related royalties to us, at which time our obligations to share the royalties payable under the Secura Bio Agreement equally with Takeda shall be reinstated. Eganelisib Pursuant to the Takeda Agreement, we are obligated to pay Takeda $3.0 million in a remaining success-based development milestone payment and up to $165.0 million in remaining regulatory and commercial-based milestone payments for one product candidate other than duvelisib, which could be eganelisib. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 12. Income Taxes We did not have any income tax expense for the years ended December 31, 2022 or 2021. Our income tax expense for the years ended December 31, 2022 and 2021 differed from the expected U.S. federal statutory income tax expense as set forth below: Years Ended December 31, 2022 2021 (in thousands) Expected federal tax benefit $ (9,317) $ (9,505) Permanent differences 215 191 State taxes, net of the deferred federal benefit (1,986) (3,024) Tax credit carryforwards (1,533) (1,416) Adjustments to deferred tax assets and deferred tax liabilities 560 226 Other 15 (93) Change in valuation allowance 12,046 13,621 Income tax expense (benefit) $ — $ — The significant components of our deferred tax assets and liabilities are as follows: Years Ended December 31, 2022 2021 (in thousands) Deferred tax assets (liabilities): Net operating loss carryforwards $ 170,880 $ 164,969 Tax credit carryforwards 45,270 44,302 Intangible assets 13,212 15,151 Capitalized research and development costs 8,104 — Accrued expenses 655 1,255 Stock-based compensation 5,183 5,109 Sale of future royalties 13,212 13,557 Other (105) 22 Valuation allowance (256,411) (244,365) Net deferred tax assets (liabilities) $ — $ — We have recorded a valuation allowance against our deferred tax assets in each of the years ended December 31, 2022, and 2021 because we believe that it is more likely than not that these assets will not be realized. The valuation allowance increased by approximately $12.0 million during the year ended December 31, 2022 primarily due to new federal tax regulations effective for the year ended December 31, 2022 requiring that research and development costs be capitalized and amortized over future periods compared to previous tax regulations which allowed for such expenses to be fully deductible in the year incurred. The increase in the valuation allowance is also largely attributable to the increase in our unbenefited net operating loss for the current period. The valuation allowance increased by approximately $13.6 million during the year ended December 31, 2021 primarily as a result of the increase in our unbenefited net operating loss for the period. Subject to the limitations described below, at December 31, 2022, we have cumulative net operating loss carryforwards of approximately $653.2 million and $533.3 million available to reduce federal and state taxable income, respectively. For federal purposes, the net operating loss carryforwards have begun to expire and will continue to expire through 2037 for losses incurred before January 1, 2018. Federal losses generated after December 31, 2017 do not expire. As of December 31, 2022, we have approximately $128.5 million of federal losses that do not expire. The state net operating loss carryforwards begin to expire in 2031 and continue to expire through 2041. In addition, we have cumulative federal and state tax credit carryforwards of $37.7 million and $9.6 million, respectively, available to reduce federal and state income taxes which expire through 2041 and 2036, respectively. Our net operating loss carryforwards and tax credit carryforwards are limited as a result of certain ownership changes, as defined under Sections 382 and 383 of the Internal Revenue Code. This limits the annual amount of these tax attributes that can be utilized to offset future taxable income or tax liabilities. The amount of the annual limitation is determined based on our value immediately prior to an ownership change. Subsequent ownership changes may affect the limitation in future years. The net operating losses and tax credit carryforwards that have and will expire unused in the future as a result of Section 382 and 383 limitations have been excluded from the amounts disclosed above. The latest Section 382 study was performed through December 31, 2021. Ownership changes after that date could further reduce the Company’s ability to utilize the net operating loss and other attribute carryforwards. At December 31, 2022 and 2021, we had no unrecognized tax benefits. As of December 31, 2022 and 2021, we had no accrued interest or penalties related to uncertain tax positions and no amounts have been recognized in our consolidated statements of operations and comprehensive loss. We will recognize interest and penalties related to uncertain tax positions in income tax expense. For all years through December 31, 2022, we generated research credits but have not conducted a study to document the qualified activities. This study may result in an adjustment to our research and development credit carryforwards; however, until a study is completed and any adjustment is known, no amounts are being presented as an uncertain tax position. A full valuation allowance has been provided against our research and development credits and, if an adjustment is required, this adjustment would be offset by an adjustment to the deferred tax asset established for the research and development credit carryforwards and the valuation allowance. We file U.S. federal and Massachusetts state income tax returns. The statute of limitations for assessment by the Internal Revenue Service, or IRS, and state tax authorities is closed for tax years prior to 2019, although carryforward attributes that were generated prior to tax year 2019 may still be adjusted upon examination by the IRS or state tax authorities if they either have been or will be used in a future period. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
Stockholders' Equity | 13. Stockholders’ (Deficit) Equity Common Stock Sales Facility On June 28, 2019, we entered into a Capital on Demand Sales Agreement with JonesTrading Institutional Services LLC, or JonesTrading, and on July 29, 2019 we amended and restated the sales agreement to add B. Riley Securities (f/k/a B. Riley FBR, Inc.), or B. Riley Securities, as a party to the agreement. On July 27, 2021, we entered into an amendment to the agreement to increase the maximum aggregate offering price of the shares of common stock that we may issue and sell from time to time under the agreement by $75.0 million to an aggregate of $95.0 million. We refer to the amended and restated sales agreement, as amended, as the ATM Sales Agreement. During the year ended December 31, 2022, a portion of the aggregate offering price totaling $11.8 million expired without sale. As of December 31, 2022, we had an aggregate of $75.0 million available for future sales. Pursuant to the ATM Sales Agreement we may offer and sell shares of our common stock from time to time through JonesTrading or B. Riley Securities, each acting as our sales agent. We have agreed to pay commissions to the sales agents for their services in acting as agents in the sale of our common stock in the amount of up to 3.0% of the gross proceeds from sales of our common stock pursuant to the ATM Sales Agreement. Sales of shares of our common stock under the ATM Sales Agreement may be made by any method that is deemed to be an “at-the-market-offering” as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended. With our prior written approval, JonesTrading or B. Riley Securities may also sell the shares by any other method permitted by law, including in negotiated transactions. We and JonesTrading or B. Riley Securities may suspend or terminate the offering of shares upon notice to the other parties and subject to other conditions. During the year ended December 31, 2022, we did not sell any shares under the ATM Sales Agreement. During the year ended December 31, 2021, we issued and sold 89,520 shares of common stock at a weighted average price per share of $3.83 at-the-market pursuant to the ATM Sales Agreement for $0.3 million in net proceeds. Public Offering On February 11, 2021, we entered into a purchase agreement with Piper Sandler & Co., as representative of the underwriters named therein, pursuant to which we issued and sold to the underwriters in an underwritten public offering an aggregate of 24,150,000 shares of our common stock, including 3,150,000 shares of common stock sold in connection with the exercise in full of a 15% over-allotment option by the underwriters. The public offering price was $3.80 per share. The gross proceeds to us from this offering were approximately $91.8 million. After underwriting discounts and commissions and offering expenses, we received net proceeds from the offering of approximately $85.8 million. Warrants |
Defined Contribution Benefit Pl
Defined Contribution Benefit Plan | 12 Months Ended |
Dec. 31, 2022 | |
Retirement Benefits [Abstract] | |
Defined Contribution Benefit Plan | 14. Defined Contribution Benefit Plan We sponsor a 401(k) retirement plan in which substantially all of our full-time employees are eligible to participate. Participants may contribute a percentage of their annual compensation to this plan, subject to statutory limitations. During the years ended December 31, 2022 and 2021, we matched participants’ contributions up to 6% of the participant’s pre-tax salary. Our matching contributions for the years ended December 31, 2022 and 2021 was $0.3 million and $0.2 million, respectively. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | 15. Subsequent Events On February 22, 2023, we, MEI Pharma, Inc., a Delaware corporation, or MEI, and Meadow Merger Sub, Inc., a Delaware corporation and a wholly owned subsidiary of MEI, or the Merger Sub, entered into an Agreement and Plan of Merger, or the Merger Agreement, pursuant to which, among other matters, and subject to the satisfaction or waiver of the conditions set forth in the Merger Agreement, Merger Sub will merge with and into Infinity, with Infinity continuing as a wholly owned subsidiary of MEI and the surviving corporation of the merger, which transaction is referred to herein as the Merger. If the Merger is completed, the combined company will combine the expertise and resources of MEI and Infinity to advance a pipeline of three clinical-stage oncology drug candidates. We expect to devote significant time and resources to the completion of the Merger. However, there can be no assurances that such activities will result in the completion of the Merger. Further, the completion of the Merger may ultimately not deliver the anticipated benefits or enhance shareholder value. If the Merger is not completed, we will consider alternative courses of action. We consider one of the following courses of action to be the most likely alternatives if the Merger is not completed: • Pursue another strategic transaction . We may resume the process of evaluating a potential strategic transaction, including the sale of the company or its assets. Based on our prior assessment, we do not expect that we would have the necessary time or financial resources to pursue another strategic transaction like the proposed Merger. • Wind down the company . If the Merger does not close and we are unable to enter into another strategic transaction, our board of directors may conclude that it is in the best interest of stockholders to cease normal operations and wind down the company through bankruptcy or dissolution proceedings. In such case, there would be no assurances as to the amount or timing of available cash remaining, if any, to distribute to stockholders after paying our obligations and setting aside funds for reserves. In conjunction with their approval of the Merger Agreement, our Board of Directors approved a strategic restructuring to preserve our resources. As a result, we have reduced our overall headcount by four positions, representing approximately 13% of our workforce at the time we entered into the Merger Agreement. We expect to incur approximately $1.6 million and $0.1 million in total restructuring charges in general and administrative expenses and research and development expenses, respectively in the first quarter of 2023. These charges primarily consist of severance payments, employee benefits and related taxes, and stock-based compensation. Of the aggregate restructuring costs, we expect approximately $0.9 million to be settled through future cash expenditures. We expect the workforce reduction will be substantially completed by March 31, 2023. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation These consolidated financial statements include the accounts of Infinity and its wholly-owned subsidiaries. We have eliminated all significant intercompany accounts and transactions in consolidation. The preparation of consolidated financial statements in accordance with generally accepted accounting principles requires our management to make estimates and judgments that may affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an ongoing basis, we evaluate our estimates and judgments. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results may differ from these estimates under different assumptions or conditions. |
Segment Information | Segment Information We operate in one business segment, which focuses on drug development. We make operating decisions based upon the performance of the enterprise as a whole and utilize our consolidated financial statements for decision making. |
Cash Equivalents and Available-For-Sale Securities | Cash Equivalents and Available-For-Sale Securities Cash equivalents consist of money market funds. We consider all highly liquid investments with maturities of three months or less at the time of purchase to be cash equivalents. Cash equivalents are stated at fair value. They are also readily convertible to known amounts of cash and have such short-term maturities that each presents insignificant risk of change in value due to changes in interest rates. Our classification of cash equivalents is consistent with prior periods. From time to time we invest our cash in short-term marketable securities. We determine the appropriate classification of marketable securities at the time of purchase and re-evaluate such designation at each balance sheet date, if applicable. Typically, the marketable securities in which we invest have been classified as “available-for-sale.” We carry available-for-sale securities at fair value. Unrealized gains and losses on available-for-sale debt securities are reported in accumulated other comprehensive (loss) income, which is a separate component of stockholders’ equity. At various points during the years ended December 31, 2022 and 2021, we owned marketable securities that were classified as available-for-sale. We did not own any such securities as of December 31, 2022 or 2021. We adjust the cost of available-for-sale debt securities for amortization of premiums and accretion of discounts to maturity. We include such amortization and accretion in investment and other income. The cost of securities sold is based on the specific identification method. We include in investment income interest and dividends on securities classified as available-for-sale. We conduct periodic reviews to identify and evaluate each available-for-sale debt security that is in an unrealized loss position in order to determine whether an other-than-temporary impairment exists. An unrealized loss exists when the current fair value of an individual security is less than its amortized cost basis. For available-for-sale debt securities in an unrealized loss position, we perform an analysis to assess whether we intend to sell or whether we would more likely than not be required to sell the security before the expected recovery of the amortized cost basis. Where we intend to sell a security, or may be required to do so, the security’s decline in fair value is deemed to be other-than-temporary, and the full amount of the unrealized loss is recorded within earnings as an impairment loss. Unrealized losses on available-for-sale debt securities that are determined to be temporary, and not related to credit loss, are recorded, net of tax, in accumulated other comprehensive loss. Regardless of our intent to sell a security, we perform additional analysis on all securities in an unrealized loss position to evaluate losses associated with the creditworthiness of the security. Credit losses are identified where we do not expect to receive cash flows sufficient to recover the amortized cost basis of a security and are recorded within earnings as an impairment loss. |
Liquidity and Going Concern | Liquidity and Going Concern As of December 31, 2022, we had cash and cash equivalents of $38.3 million. We have primarily incurred operating losses since inception and have relied on our ability to fund our operations through collaboration and license arrangements, or other strategic arrangements, and through the sale of our common stock. We expect to continue to spend significant resources to fund the development and potential commercialization of eganelisib, also known as IPI-549, an orally administered immuno-oncology product candidate that selectively inhibits the enzyme phosphoinositide-3-kinase gamma, or PI3K-gamma, and to incur significant operating losses for the foreseeable future. As of December 31, 2022, we had an accumulated deficit of $856.0 million and during the year ended December 31, 2022 used $42.4 million in cash and cash equivalents to fund operating activities. We expect to continue to incur substantial operating losses and negative cash flows from operations for the foreseeable future. These conditions raise substantial doubt about our ability to continue as a going concern for at least twelve months from the date these consolidated financial statements are issued on March 28, 2023. If the Merger is not completed, we will need to raise additional capital in order to successfully execute on our current operating plans to further the development of eganelisib. If the Merger is not completed, we will explore other plans to mitigate the conditions which raise substantial doubt about our ability to continue as a going concern. We consider one of the following courses of action to be the most likely alternatives if the Merger is not completed: • Pursue another strategic transaction . We may resume the process of evaluating a potential strategic transaction, including the sale of the company or its assets. Based on our prior assessment, we do not expect that we would have the necessary time or financial resources to pursue another strategic transaction like the proposed Merger. • Wind down the company . If the Merger does not close and we are unable to enter into another strategic transaction, our board of directors may conclude that it is in the best interest of stockholders to cease normal operations and wind down the company through bankruptcy or dissolution proceedings. In such case, there would be no assurances as to the amount or timing of available cash remaining, if any, to distribute to stockholders after paying our obligations and setting aside funds for reserves. Our consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and settlement of liabilities and commitments in the ordinary course of business. The consolidated financial statements do not include any adjustments that might result from the outcome of the conditions described above. |
Concentration of Credit Risk | Concentration of Credit Risk Cash and cash equivalents are primarily maintained with two major financial institutions in the United States. Deposits at banks may exceed the insurance provided on such deposits. Generally, these deposits may be redeemed upon demand and, therefore, bear minimal risk. From time to time the Company invests its cash in other financial instruments that potentially subject us to concentration of credit risk, primarily consisting of available-for-sale securities. Our investment policy, which has been approved by our Board of Directors, limits the amount that we may invest in any one issuer of investments, thereby reducing credit risk concentrations. As of December 31, 2022 and 2021, the Company did not have any cash or cash equivalents invested in available-for-sale securities. |
Property and Equipment | Property and Equipment Property and equipment are stated at cost. Depreciation is recorded using the straight-line method over the estimated useful lives of the applicable assets. Application development costs incurred for computer software developed or obtained for internal use are capitalized. Upon sale or retirement, the cost and related accumulated depreciation are eliminated from the respective account, and the resulting gain or loss, if any, is included in current operations. Amortization of leasehold improvements, building improvements and finance leases is recorded as depreciation expense and included in research and development and general and administrative expense, as applicable. Repairs and maintenance charges that do not increase the useful life of the assets are charged to operations as incurred. Property and equipment are depreciated over the following periods: Computer equipment and software 3 to 5 years Leasehold improvements Shorter of lease term or useful life of asset Furniture and fixtures 7 to 10 years |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets We evaluate our long-lived assets for potential impairment. Potential impairment is assessed when there is evidence that events or changes in circumstances have occurred that indicate that the carrying amount of a long-lived asset may not be recovered. Recoverability of these assets is assessed based on undiscounted expected future cash flows from the assets, considering a number of factors, including past operating results, budgets and economic projections, market trends and product development cycles. An impairment in the carrying value of each asset is assessed when the undiscounted expected future cash flows, including its eventual residual value, derived from the asset are less than its carrying value. Impairments, if any, are recognized in earnings. An impairment loss would be recognized in an amount equal to the excess of the carrying amount over the undiscounted expected future cash flows. |
Fair Value Measurements | Fair Value Measurements We define fair value as the price that we would receive to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. We determine fair value based on the assumptions market participants use when pricing the asset or liability. We use a valuation hierarchy for disclosure of the inputs used to measure fair value. This hierarchy prioritizes the inputs into three broad levels. Level 1 inputs, which we consider the highest level inputs, are quoted prices (unadjusted) in active markets for identical assets or liabilities. Level 2 inputs are quoted prices for similar assets and liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument. Level 3 inputs are unobservable inputs based on our own assumptions used to measure assets and liabilities at fair value. The classification of a financial asset or liability within the hierarchy is determined based on the lowest level input that is significant to the fair value measurement. |
Liabilities Related to Sale of Future Royalties | Liabilities Related to Sale of Future Royalties We treat the liabilities related to sale of future royalties (see Note 9) as debt financings, amortized under the effective interest rate method over the estimated life of the related expected royalty stream. The liabilities related to sale of future royalties and the debt amortization are based on our current estimates of future royalties expected to be paid over the life of the arrangement. We will periodically assess the expected royalty payments using projections from external sources. To the extent our estimates of future royalty payments are greater or less than previous estimates or the estimated timing of such payments is materially different than previous estimates, we will adjust the effective interest rate and recognize related non-cash interest expense on a prospective basis. Non-cash royalty revenue is reflected as royalty revenue, and non-cash amortization of debt is reflected as non-cash interest expense in the Consolidated Statements of Operations and Comprehensive Loss. |
Leases | Leases We have entered into leases for office space and a data center. As of January 1, 2019, we adopted the provisions of Accounting Standards Codification, or ASC, Topic 842, Leases, or ASC 842. Accordingly, we recorded a right-of-use asset and a corresponding lease liability related to our leases. Rights and obligations related to our leases are included within operating lease right-of-use assets, accrued expenses and other current liabilities, and operating lease liability, less current portion in the Consolidated Balance Sheets. We recognize a right-of-use asset and a lease liability upon the commencement of a lease that has a term of more than twelve months. We combine lease and nonlease components for our leases. Lease payments included in determining the right-of-use asset and lease liability recognized include fixed payments to be paid over the term of the lease, less any lease incentives to be paid or payable to us by the lessor. Variable lease payments are included if they are based on an index or rate. Variable lease payments that are not based on an index or rate are recognized as expense in the period incurred. The lease term is determined at lease commencement, and includes the noncancellable period during which we have the right to use the underlying asset. Any period covered by an option to extend or terminate a lease is also included in the lease term if we are reasonably certain that the option to extend will be exercised or the option to terminate will not be exercised. |
Revenue Recognition | Revenue Recognition To date, all our revenue has been generated under collaboration agreements, including payments to us of upfront license fees, funding or reimbursement of research and development efforts, milestone payments, if specified objectives are achieved, and royalties on product sales. We recognize revenue when we transfer goods or services to customers in an amount that reflects the consideration that we expect to receive for those goods or services. These principles are applied using a five-step model: 1) identify the customer contract; 2) identify the contract’s performance obligations; 3) determine the transaction price; 4) allocate the transaction price to the performance obligations; and 5) recognize revenue when or as a performance obligation is satisfied. We evaluate all promised goods and services within a customer contract and determine which of those are separate performance obligations. This evaluation includes an assessment of whether the good or service is capable of being distinct and whether the good or service is separable from other promises in the contract. When a performance obligation is satisfied, we recognize as revenue the amount of the transaction price, excluding estimates of variable consideration that are constrained, that is allocated to that performance obligation. For contracts that contain variable consideration, such as milestone payments, we estimate the amount of variable consideration by using either the expected value method or the most likely amount method. In making this assessment, we evaluate factors such as the clinical, regulatory, commercial and other risks that must be overcome to achieve the milestone. Each reporting period we re-evaluate the probability of achievement of such milestones and any related constraints. We will include variable consideration, without constraint, in the transaction price to the extent 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. We recognize sales-based milestones and royalty revenue based upon net sales by the licensee of licensed products in licensed territories, and in the period the sales occur under the sales- and usage-based royalty exception when the sole or predominate item to which the royalty relates is a license to intellectual property. In the event of an early termination of a collaboration agreement, any contract liabilities would be recognized in the period in which all our obligations under the agreement have been fulfilled. |
Research and Development Expense | Research and Development Expense Research and development expense consists of expenses incurred in performing research and development activities, including salaries and benefits, overhead expenses including facilities expenses, materials and supplies, preclinical expenses, clinical trial and related clinical manufacturing expenses, comparator and combination drug expenses, stock-based compensation expense, depreciation of property and equipment, contract services, and other outside expenses. We also include as research and development expense upfront license payments related to acquired technologies which have not yet reached technological feasibility and have no alternative use. We expense research and development costs as they are incurred. Prepaid comparator and combination drug expenses are capitalized and then recognized as expense when title transfers to us. We have been a party to collaboration agreements in which we were reimbursed for work performed on behalf of the collaborator, as well as one in which we reimbursed the collaborator for work it had performed. We record all appropriate expenses under our collaborations as research and development expense. If the arrangement provides for reimbursement of research and development expenses incurred by us, we evaluate the terms of the arrangement to determine whether the reimbursement should be recorded as revenue or as an offset to research and development expense. If the arrangement provides for us to reimburse the collaborator for research and development expenses or for the achievement of a development milestone for which a payment is due, we record the reimbursement or the achievement of the development milestone as research and development expense. |
Stock-based Compensation Expense | Stock-based Compensation ExpenseWe issue stock-based awards to employees, directors, and non-employees, generally in the form of stock options, restricted stock units, or RSUs, or as awards under our 2013 Employee Stock Purchase Plan, or ESPP. We measure stock-based compensation cost at the grant date based on the estimated fair value of the award and recognize it as expense over the requisite service period on a straight-line basis. Stock-based compensation costs for non-employees are recognized as expense over the vesting period on a ratable basis. The grant date fair value of stock options and awards under our ESPP is measured using the Black-Scholes valuation model, which requires us to make assumptions about the fair value of our common stock on the date of grant. The grant date fair value of RSUs is estimated to be equal to the closing price of our common stock on the date of grant. For awards with performance conditions, we estimate the likelihood of satisfaction of the performance conditions, which affects the period over which the expense is recognized. When the likelihood of satisfying the performance conditions related to these awards is determined to be probable, we recognize the expense over the requisite service period. |
Royalty Expense | Royalty Expense Royalty expense is recorded when incurred and represents the expense associated with amounts owed to third parties as a result of royalty revenue recognized and the amounts owed by us to Takeda Pharmaceutical Company Limited, or Takeda, in relation to the sale of future royalties (see Note 11). |
Income Taxes | Income Taxes We use the liability method to account for income taxes. Deferred tax assets and liabilities are determined based on differences between financial reporting and income tax basis of assets and liabilities, as well as net operating loss and tax credit carryforwards, and are measured using the enacted tax rates and laws that will be in effect when the differences reverse. Deferred tax assets are reduced by a valuation allowance to reflect the uncertainty associated with their ultimate realization. The effect of a change in tax rate on deferred taxes is recognized in income or loss in the period that includes the enactment date. We use our judgment for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. We recognize any material interest and penalties related to unrecognized tax benefits in income tax expense. |
Basic and Diluted Net Loss per Common Share | Basic and Diluted Net Loss per Common ShareBasic net loss per share is based upon the weighted average number of common shares outstanding during the period, excluding restricted stock units that have been issued but have not yet vested. Diluted net loss per share is based upon the weighted average number of common shares outstanding during the period plus the effect of additional weighted average common equivalent shares outstanding during the period when the effect of adding such shares is dilutive. Common equivalent shares result from the assumed exercise of outstanding stock options and the exercise of outstanding warrants (the proceeds of which are then assumed to have been used to repurchase outstanding stock using the treasury stock method) and the vesting of restricted shares of common stock. In addition, the assumed proceeds under the treasury stock method include the average unrecognized compensation expense of stock options that are in-the-money. This results in the “assumed” buyback of additional shares, thereby reducing the dilutive impact of stock options. The two-class method is used for outstanding warrants as such warrants are considered to be participating securities, and this method is more dilutive than the treasury stock method. |
Comprehensive Loss | Comprehensive LossComprehensive loss is comprised of net loss and other comprehensive loss. Other comprehensive loss is comprised of unrealized holding gains arising during the period on available-for-sale securities that are not other-than-temporarily impaired. |
New Accounting Pronouncements | New Accounting Pronouncements In June 2016, the Financial Accounting Standards Board, or FASB, issued Accounting Standard Update, or ASU, No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Statements , or ASU No. 2016-13, which requires that credit losses be reported using an expected losses model rather than the incurred losses model that is currently used, and it establishes additional disclosure requirements related to credit risks. For available-for-sale debt securities with expected credit losses, this standard now requires allowances to be recorded instead of reducing the amortized cost of the investment. In November 2019, the FASB subsequently issued ASU 2019-10, Financial Instruments—Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842): Effective Dates , whereby the effective date of this standard for smaller reporting companies was deferred to annual reporting periods beginning after December 15, 2022, including interim periods within those annual reporting periods, and early adoption is still permitted. We adopted this standard effective January 1, 2023 on a prospective basis. The adoption of this standard has not had a material impact on our consolidated financial statements and related disclosures. In August 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 , or ASU No. 2020-06, which simplifies the guidance on an issuer’s accounting for convertible instruments and contracts in its own equity. The provisions of ASU No. 2020-06 are applicable for fiscal years beginning after December 15, 2023, with early adoption permitted no earlier than fiscal years beginning after December 15, 2020. We are currently evaluating the impact of ASU No. 2020-06 on our consolidated financial statements and related disclosures. In November 2021, the FASB issued ASU No. 2021-10, Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance , or ASU No. 2021-10, which requires additional annual disclosures about transactions with a government that are accounted for by applying a grant or contribution accounting model by analogy. The additional disclosures required by this standard include 1) information about the nature of the transactions and the related accounting policy used to account for the transactions, 2) the financial statement line items that are impacted by the transactions and the amounts applicable to each financial statement line item and 3) significant terms and conditions of the transactions, including commitments and contingencies. We adopted this standard effective January 1, 2022 on a prospective basis. The adoption of the standard has not had a material impact on our consolidated financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Property and Equipment, Depreciated Periods | Property and equipment are depreciated over the following periods: Computer equipment and software 3 to 5 years Leasehold improvements Shorter of lease term or useful life of asset Furniture and fixtures 7 to 10 years |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The following outstanding shares of common stock equivalents were excluded from the computation of net loss per share attributable to common stockholders for the periods presented because including them would have been antidilutive: At December 31, 2022 2021 Stock options 14,663,697 12,689,439 Non-vested restricted stock 2,939,816 50,000 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation Expense, Related to All Equity Awards | Total stock-based compensation expense related to all equity awards was comprised of the following: Year Ended December 31, 2022 2021 (in thousands) Research and development $ 1,291 $ 830 General and administrative 2,330 1,865 Total stock-based compensation expense $ 3,621 $ 2,695 |
Black-Scholes Valuation Model, Weighted-Average Assumptions for Stock Options | We estimate the fair value of stock options at the date of grant using the Black-Scholes valuation model with the following weighted-average assumptions: December 31, 2022 2021 Risk-free interest rate 2.1 % 0.9 % Expected annual dividend yield — — Expected stock price volatility 105.0 % 106.3 % Expected term of options 5.9 years 5.9 years |
Summary of Stock Option Activity | A summary of our stock option activity for the year ended December 31, 2022 is as follows: Stock Options Weighted-Average Weighted-Average Aggregate Outstanding at January 1, 2022 12,689,439 $ 3.53 Granted 2,886,324 1.36 Exercised (17,708) 0.83 Forfeited (238,129) 1.46 Expired (656,229) 8.30 Outstanding at December 31, 2022 14,663,697 $ 2.93 6.3 $ — Exercisable at December 31, 2022 10,903,188 $ 3.33 5.6 $ — |
Summary of RSU Activity | A summary of our RSU activity for the year ended December 31, 2022 is as follows: Restricted Stock Units Weighted-Average Outstanding, non-vested at January 1, 2022 50,000 $ 2.93 Granted 2,950,483 1.08 Vested (50,000) 2.93 Forfeited (10,667) 1.08 Outstanding, non-vested at December 31, 2022 2,939,816 $ 1.08 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Prepaid Expense and Other Assets, Current [Abstract] | |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consist of the following: December 31, 2022 2021 (in thousands) Prepaid expenses $ 1,429 $ 1,143 Other current assets 560 399 Total prepaid expenses and other current assets $ 1,989 $ 1,542 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Summary of Property and Equipment | Property and equipment consist of the following: December 31, 2022 2021 (in thousands) Computer equipment and software $ 1,921 $ 1,904 Furniture and fixtures 446 446 Leasehold improvements 1,743 1,743 4,110 4,093 Less accumulated depreciation (3,310) (2,852) $ 800 $ 1,241 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses and other current liabilities consisted of the following: December 31, 2022 2021 (in thousands) Accrued clinical $ 4,290 $ 4,998 Accrued professional services 785 88 Accrued consulting 742 475 Accrued compensation and benefits 605 2,835 Accrued development 335 755 Liability related to sale of future royalties, net, current portion 1,218 897 Operating lease liability, current portion 593 519 Other 655 413 Total accrued expenses $ 9,223 $ 10,980 |
Liabilities Related to Sale o_2
Liabilities Related to Sale of Future Royalties (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Schedule of Liability Related to Future Sale of Royalties | The following table shows the activity within the liability account for the years ended December 31, 2022 and 2021: December 31, 2022 2021 (in thousands) Liability related to sale of future royalties - beginning balance $ 28,038 $ 28,869 Non-cash royalty revenue (1,373) (984) Non-cash interest expense recognized 153 153 Liability related to sale of future royalties, net - ending balance $ 26,818 $ 28,038 Less: current portion (1,218) (897) Liability related to sale of future royalties, net, less current portion $ 25,600 $ 27,141 The following table shows the activity within the liability account for the years ended December 31, 2022 and 2021: December 31, 2022 2021 (in thousands) Liability related to sale of future royalties - beginning balance $ 21,586 $ 21,559 Non-cash interest expense recognized 27 27 Liability related to sale of future royalties, net - ending balance $ 21,613 $ 21,586 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Summary of Leases | The following is a summary of our current lease included in the respective balance sheet classifications: December 31, 2022 2021 Assets (in thousands) Operating lease right-of-use assets $ 697 $ 1,064 Liabilities Accrued expenses and other current liabilities $ 593 $ 519 Operating lease liability 324 917 Total lease liabilities $ 917 $ 1,436 |
Schedule of Future Minimum Lease Payments | As of December 31, 2022, future minimum lease payments of our operating lease liabilities are as follows: Operating Leases (in thousands) 2023 $ 658 2024 334 Total future minimum lease payments 992 Less: imputed interest (75) Total lease liability $ 917 |
Strategic Agreements (Tables)
Strategic Agreements (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Summary of Payments Made to Counterparty, Multiplier | We have the right to extinguish the Interim Obligation by payment to Takeda of an amount equal to (i) the $6.7 million payment multiplied by the multiple set forth in the table below corresponding to the time period in which such extinguishing payment is made, minus (ii) any payments made to Takeda pursuant to the Interim Obligation: Time Period Multiple From the Takeda Amendment Effective Date until June 30, 2022 145 % From July 1, 2022 through June 30, 2023 155 % From July 1, 2023 through June 30, 2024 165 % From July 1, 2024 through June 30, 2025 175 % |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Tax Benefit or Expense | Our income tax expense for the years ended December 31, 2022 and 2021 differed from the expected U.S. federal statutory income tax expense as set forth below: Years Ended December 31, 2022 2021 (in thousands) Expected federal tax benefit $ (9,317) $ (9,505) Permanent differences 215 191 State taxes, net of the deferred federal benefit (1,986) (3,024) Tax credit carryforwards (1,533) (1,416) Adjustments to deferred tax assets and deferred tax liabilities 560 226 Other 15 (93) Change in valuation allowance 12,046 13,621 Income tax expense (benefit) $ — $ — |
Significant Components of Deferred Tax Assets | The significant components of our deferred tax assets and liabilities are as follows: Years Ended December 31, 2022 2021 (in thousands) Deferred tax assets (liabilities): Net operating loss carryforwards $ 170,880 $ 164,969 Tax credit carryforwards 45,270 44,302 Intangible assets 13,212 15,151 Capitalized research and development costs 8,104 — Accrued expenses 655 1,255 Stock-based compensation 5,183 5,109 Sale of future royalties 13,212 13,557 Other (105) 22 Valuation allowance (256,411) (244,365) Net deferred tax assets (liabilities) $ — $ — |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Details) | 12 Months Ended | |
Dec. 31, 2022 USD ($) award institution issuer segment | Dec. 31, 2021 USD ($) | |
Accounting Policies [Abstract] | ||
Number of operating segments | segment | 1 | |
Cash, cash equivalents, and available-for-sale securities | $ 38,300,000 | |
Accumulated deficit | 855,952,000 | $ 811,583,000 |
Net Cash Provided by (Used in) Operating Activities | $ (42,431,000) | $ (40,618,000) |
Number of major financial institutions | institution | 2 | |
Number of issuers of investments | issuer | 1 | |
Number of awards with market conditions | award | 0 | |
Reclassifications out of accumulated other comprehensive income (loss) | $ 0 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Property and Equipment, Depreciation Periods (Details) | 12 Months Ended |
Dec. 31, 2022 | |
Computer equipment and software | Minimum | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life | 3 years |
Computer equipment and software | Maximum | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life | 5 years |
Furniture and fixtures | Minimum | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life | 7 years |
Furniture and fixtures | Maximum | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life | 10 years |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Antidilutive Securities (Details) - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 14,663,697 | 12,689,439 |
Non-vested restricted stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 2,939,816 | 50,000 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) | 12 Months Ended | |
Dec. 31, 2022 USD ($) period $ / shares shares | Dec. 31, 2021 USD ($) $ / shares shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Unrecognized compensation cost, net of estimated forfeitures, related to unvested options and restricted stock | $ | $ 8,100,000 | |
Unrecognized compensation cost, weighted-average recognition period, stock options | 2 years | |
Weighted-average fair value per share of options granted (in dollars per share) | $ / shares | $ 1.10 | $ 2.69 |
Aggregate intrinsic value | $ | $ 0 | $ 800,000 |
Related income tax benefits | $ | $ 0 | $ 0 |
Stock Incentive Plan, All Plans | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Percentage of shares vested | 25% | |
Remaining percentage of shares vested | 75% | |
Vesting period, following first year of service, new employees | 3 years | |
Stock options granted, expiration period (no later than) | 10 years | |
2019 Equity Incentive Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Common stock Issued pursuant to awards granted (up to) (in shares) | 12,531,009 | |
Common stock reserved for issuance upon exercise of outstanding awards (in shares) | 7,744,676 | |
Common stock that can be issued pursuant to awards granted (up to) (in shares) | 2,564,077 | |
2010 Stock Incentive Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Common stock reserved for issuance upon exercise of outstanding awards (in shares) | 6,309,021 | |
2013 Employee Stock Purchase Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Common stock offering aggregate period | 24 months | |
Number of common stock purchase periods | period | 4 | |
Common stock offering purchase period | 6 months | |
Percentage of common stock purchase price | 85% | |
Number of common stock purchased (in shares) | 111,155 | 57,561 |
Proceeds from purchase of common stock | $ | $ 100,000 | $ 100,000 |
Stock options | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected annual dividend yield | 0% | 0% |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | $ 3,621 | $ 2,695 |
Research and development | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | 1,291 | 830 |
General and administrative | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | $ 2,330 | $ 1,865 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock Options (Details) - Stock Options | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 2.10% | 0.90% |
Expected annual dividend yield | 0% | 0% |
Expected stock price volatility | 105% | 106.30% |
Expected term of options | 5 years 10 months 24 days | 5 years 10 months 24 days |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity (Details) $ / shares in Units, $ in Millions | 12 Months Ended |
Dec. 31, 2022 USD ($) $ / shares shares | |
Stock Options | |
Outstanding at beginning of period (in shares) | shares | 12,689,439 |
Granted (in shares) | shares | 2,886,324 |
Exercised (in shares) | shares | (17,708) |
Forfeited (in shares) | shares | (238,129) |
Expired (in shares) | shares | (656,229) |
Outstanding at end of period (in shares) | shares | 14,663,697 |
Exercisable at end of period (in shares) | shares | 10,903,188 |
Weighted-Average Exercise Price per Share | |
Outstanding at beginning of period (in dollars per share) | $ / shares | $ 3.53 |
Granted (in dollars per share) | $ / shares | 1.36 |
Exercised (in dollars per share) | $ / shares | 0.83 |
Forfeited (in dollars per share) | $ / shares | 1.46 |
Expired (in dollars per share) | $ / shares | 8.30 |
Outstanding at end of period (in dollars per share) | $ / shares | 2.93 |
Exercisable at end of period (in dollars per share) | $ / shares | $ 3.33 |
Weighted-Average Remaining Contractual Life (years) | |
Outstanding at end of period | 6 years 3 months 18 days |
Exercisable at end of period | 5 years 7 months 6 days |
Aggregate Intrinsic Value | |
Outstanding at end of period | $ | $ 0 |
Exercisable at end of period | $ | $ 0 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Restricted Stock Activity (Details) - Restricted Stock - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Restricted Stock | ||
Unvested, Beginning of the period (in shares) | 50,000 | |
Granted (in shares) | 2,950,483 | |
Vested (in shares) | (50,000) | 0 |
Forfeited (in shares) | (10,667) | |
Unvested, End of the period (in shares) | 2,939,816 | 50,000 |
Weighted-Average Grant-Date Fair Value | ||
Unvested, Beginning of the period (in dollars per share) | $ 2.93 | |
Granted (in dollars per share) | 1.08 | |
Vested (in dollars per share) | 2.93 | |
Forfeited (in dollars per share) | 1.08 | |
Unvested, End of the period (in dollars per share) | $ 1.08 | $ 2.93 |
Fair value of RSU's vested | $ 0 |
Cash, Cash Equivalents and Av_2
Cash, Cash Equivalents and Available-for-Sale Securities - (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Cash and Cash Equivalents [Abstract] | ||
Cash and cash equivalents | $ 38,313 | $ 80,726 |
Unrealized gains (losses) on cash and cash equivalents | 0 | 0 |
Material realized gain (loss) | $ 0 | $ 0 |
Fair Value (Details)
Fair Value (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Cash and cash equivalents | $ 38,313,000 | $ 80,726,000 |
Target net asset value | 1 | |
Fair Value, Inputs, Level 3 | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale securities | 0 | |
Fair Value, Inputs, Level 3 | Fair Value, Measurements, Recurring | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Warrant liability | $ 200,000 | $ 200,000 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Prepaid Expense and Other Assets, Current [Abstract] | ||
Prepaid expenses | $ 1,429 | $ 1,143 |
Other current assets | 560 | 399 |
Total prepaid expenses and other current assets | $ 1,989 | $ 1,542 |
Property and Equipment - Summar
Property and Equipment - Summary of Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 4,110 | $ 4,093 |
Less accumulated depreciation | (3,310) | (2,852) |
Property, plant and equipment, net | 800 | 1,241 |
Computer equipment and software | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 1,921 | 1,904 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | 446 | 446 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 1,743 | $ 1,743 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Payables and Accruals [Abstract] | ||
Accrued clinical | $ 4,290 | $ 4,998 |
Accrued professional services | 785 | 88 |
Accrued consulting | 742 | 475 |
Accrued compensation and benefits | 605 | 2,835 |
Accrued development | 335 | 755 |
Liability related to sale of future royalties, net, current portion | 1,218 | 897 |
Operating lease liability, current portion | 593 | 519 |
Other | 655 | 413 |
Total accrued expenses | $ 9,223 | $ 10,980 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Total accrued expenses | Total accrued expenses |
Liabilities Related to Sale o_3
Liabilities Related to Sale of Future Royalties - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | ||
Jan. 08, 2020 | Mar. 31, 2019 | Dec. 31, 2022 | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||
Number of warrants issued (in shares) | 0 | ||
BVF Funding Agreement | |||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||
Warrant threshold, price per share (in dollars per share) | $ 3.75 | ||
Holdco | Infinity Pharmaceuticals | BVF Funding Agreement | |||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||
Option to purchase, percentage of outstanding equity interests | 100% | ||
HealthCare Royalty Partners III, L.P. | |||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||
Closing day payment | $ 30 | ||
Gross proceeds | 22.5 | ||
Net proceeds | 20.9 | ||
Deferred transaction costs amortized | $ 2.4 | ||
BVF And Royalty Security, LLC | BVF Funding Agreement | |||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||
Deferred transaction costs amortized | $ 0.4 | ||
Upfront purchase price | 20 | ||
Warrant liability | $ 0.3 | ||
Period after closing date | 36 months | ||
Percentage of common stock called by warrant | 50% | ||
Exercise price of warrant, percentage of price per share | 150% |
Liabilities Related to Sale o_4
Liabilities Related to Sale of Future Royalties - Liability Activity (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Liability Related To Future Sale Of Royalties [Roll Forward] | ||
Non-cash royalty revenue | $ (1,373) | $ (984) |
Non-cash interest expense recognized | 180 | 180 |
Less: current portion | (1,218) | (897) |
Liability related to sale of future royalties, net, less current portion | 47,213 | 48,727 |
HCR Agreement | ||
Liability Related To Future Sale Of Royalties [Roll Forward] | ||
Liability related to sale of future royalties - beginning balance | 28,038 | 28,869 |
Non-cash interest expense recognized | 153 | 153 |
Liability related to sale of future royalties, net - ending balance | 26,818 | 28,038 |
Less: current portion | (1,218) | (897) |
Liability related to sale of future royalties, net, less current portion | 25,600 | 27,141 |
HCR Agreement | Royalty revenue | ||
Liability Related To Future Sale Of Royalties [Roll Forward] | ||
Non-cash royalty revenue | (1,373) | (984) |
BVF Funding Agreement | ||
Liability Related To Future Sale Of Royalties [Roll Forward] | ||
Liability related to sale of future royalties - beginning balance | 21,586 | 21,559 |
Non-cash interest expense recognized | 27 | 27 |
Liability related to sale of future royalties, net - ending balance | $ 21,613 | $ 21,586 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) | 12 Months Ended | 48 Months Ended | |||
Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Jul. 31, 2020 USD ($) | Aug. 01, 2024 | Apr. 03, 2019 USD ($) ft² | |
Operating Leased Assets [Line Items] | |||||
Option to extend, term | 2 years | ||||
Weighted average remaining lease term | 1 year 7 months 6 days | 2 years 7 months 6 days | |||
Weighted average discount rate | 10% | 10% | |||
Operating lease costs | $ 700,000 | $ 700,000 | |||
Lease payments | 600,000 | 700,000 | |||
1100 Massachusetts Avenue, Cambridge, Massachusetts | |||||
Operating Leased Assets [Line Items] | |||||
Area of premises leased under lease agreement | ft² | 10,097 | ||||
Lease term | 5 years | ||||
Monthly base rent expense | $ 47,961 | ||||
Restricted cash, less current portion | $ 7,500 | 7,500 | |||
Leasehold improvements | $ 600,000 | ||||
Forecast | 1100 Massachusetts Avenue, Cambridge, Massachusetts | |||||
Operating Leased Assets [Line Items] | |||||
Annual percentage increase of rent expense | 3% | ||||
Letter of Credit | 1100 Massachusetts Avenue, Cambridge, Massachusetts | |||||
Operating Leased Assets [Line Items] | |||||
Security deposit | $ 300,000 | ||||
Security deposit, reduced amount under lease term | $ 150,000 |
Commitments and Contingencies_2
Commitments and Contingencies - Summary of Leases (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Assets | ||
Operating lease right-of-use assets | $ 697 | $ 1,064 |
Liabilities | ||
Accrued expenses and other current liabilities | 593 | 519 |
Operating lease liability | 324 | 917 |
Total lease liabilities | $ 917 | $ 1,436 |
Commitments and Contingencies_3
Commitments and Contingencies - Schedule of Future Minimum Lease Payments (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Leases [Abstract] | ||
2023 | $ 658 | |
2024 | 334 | |
Total future minimum lease payments | 992 | |
Less: imputed interest | (75) | |
Total lease liabilities | $ 917 | $ 1,436 |
Strategic Agreements - Addition
Strategic Agreements - Additional Information (Details) | 1 Months Ended | 12 Months Ended | |||
Mar. 04, 2019 USD ($) | Mar. 31, 2019 USD ($) | Jun. 30, 2013 USD ($) | Dec. 31, 2022 USD ($) product | Dec. 31, 2021 USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Royalty expense | $ 1,563,000 | $ 1,120,000 | |||
Number of distinct product candidates | product | 1 | ||||
Trailing Mundipharma | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Royalty percentage on sales, reimbursement of research and development, percentage | 4% | ||||
Royalty payments, reimbursement of research and development upon completion | $ 260,000,000 | ||||
Royalty percentage on sales, reimbursement of research and development upon completion, percentage | 1% | ||||
Royalty payments, reimbursement of research and development | $ 3,500,000 | ||||
Sol-Gel Agreement | Hedgehog Products | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Collaborative agreement, total remaining milestone payment amount | $ 9,000,000 | ||||
Collaborative agreement, additional milestone payments amount, if circumstances met | $ 37,500,000 | ||||
Maximum | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Additional success-based milestone payments to be paid | 165,000,000 | ||||
Current | Maximum | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Success-based remaining milestone payments | 3,000,000 | ||||
Takeda | Takeda Agreement, Fourth Amendment | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Investment amount to be paid | $ 6,700,000 | ||||
Percentage of investment amount | 25% | ||||
Percentage of net expenses incurred | 25% | ||||
Percentage of royalty payments | 25% | ||||
Royalty expense | $ 300,000 | $ 200,000 | |||
HealthCare Royalty Partners III, L.P. | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Closing day payment | $ 30,000,000 |
Strategic Agreements - Takeda A
Strategic Agreements - Takeda Agreement (Details) - Takeda | Mar. 04, 2019 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
From the Takeda Amendment Effective Date until June 30, 2022 | 145% |
From July 1, 2022 through June 30, 2023 | 155% |
From July 1, 2023 through June 30, 2024 | 165% |
From July 1, 2024 through June 30, 2025 | 175% |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Line Items] | ||
Income tax expense (benefit) | $ 0 | $ 0 |
Decrease in valuation allowance against deferred tax assets | 12,000,000 | 13,600,000 |
Unrecognized tax benefits | 0 | 0 |
Interest and penalties accrued | 0 | 0 |
Interest and penalties expensed | 0 | $ 0 |
Federal | ||
Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Line Items] | ||
Operating loss carry-forward, net | 653,200,000 | |
Operating loss carryforward, not subject to expiration | 128,500,000 | |
Tax credit carry-forward amount | 37,700,000 | |
State | ||
Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Line Items] | ||
Operating loss carry-forward, net | 533,300,000 | |
Tax credit carry-forward amount | $ 9,600,000 |
Income Taxes - Effective Income
Income Taxes - Effective Income Tax Rate Reconciliation (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
Expected federal tax benefit | $ (9,317,000) | $ (9,505,000) |
Permanent differences | 215,000 | 191,000 |
State taxes, net of the deferred federal benefit | (1,986,000) | (3,024,000) |
Tax credit carryforwards | (1,533,000) | (1,416,000) |
Adjustments to deferred tax assets and deferred tax liabilities | 560,000 | 226,000 |
Other | 15,000 | (93,000) |
Change in valuation allowance | 12,046,000 | 13,621,000 |
Income tax expense (benefit) | $ 0 | $ 0 |
Income Taxes - Deferred Tax Ass
Income Taxes - Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred tax assets (liabilities): | ||
Net operating loss carryforwards | $ 170,880 | $ 164,969 |
Tax credit carryforwards | 45,270 | 44,302 |
Intangible assets | 13,212 | 15,151 |
Capitalized research and development costs | 8,104 | 0 |
Accrued expenses | 655 | 1,255 |
Stock-based compensation | 5,183 | 5,109 |
Sale of future royalties | 13,212 | 13,557 |
Other | 22 | |
Other | (105) | |
Valuation allowance | (256,411) | (244,365) |
Net deferred tax assets (liabilities) | $ 0 | $ 0 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | ||||
Jul. 27, 2021 | Feb. 11, 2021 | Feb. 24, 2014 | Dec. 31, 2022 | Dec. 31, 2021 | |
Subsidiary, Sale of Stock [Line Items] | |||||
Sales agreement, commission percentage | 3% | ||||
Common stock warrants issued (in shares) | 1,000,000 | ||||
Common stock warrants issued, exercise price (in dollars per share) | $ 13.83 | ||||
Potential percentage of ownership interest (in excess of) | 9.985% | ||||
Common Stock Sales Facility | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Sales agreement, increase in aggregate offering price | $ 75 | ||||
Sales agreement | $ 95 | ||||
Sales agreement, expired without sale | $ 11.8 | ||||
Amount available for future sales | $ 75 | ||||
Number of shares sold in transaction (in shares) | 89,520 | ||||
Sale of stock, price per share (in dollars per share) | $ 3.83 | ||||
Sale of stock, consideration received on transaction | $ 0.3 | ||||
Public Offering | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Number of shares sold in transaction (in shares) | 24,150,000 | ||||
Sale of stock, price per share (in dollars per share) | $ 3.80 | ||||
Sale of stock, consideration received on transaction | $ 85.8 | ||||
Sale of stock, over-allotment option, percentage | 15% | ||||
Gross proceeds from shares sold | $ 91.8 | ||||
Over-Allotment Option | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Number of shares sold in transaction (in shares) | 3,150,000 |
Defined Contribution Benefit _2
Defined Contribution Benefit Plan (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Retirement Benefits [Abstract] | ||
Participant contributions, employee | 6% | 6% |
Employer matching contribution | $ 0.3 | $ 0.2 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) $ in Millions | 3 Months Ended | |
Feb. 22, 2023 USD ($) position | Mar. 31, 2023 USD ($) | |
General and administrative | Forecast | ||
Subsequent Event [Line Items] | ||
Restructuring charges | $ 1.6 | |
Research and development | Forecast | ||
Subsequent Event [Line Items] | ||
Restructuring charges | $ 0.1 | |
Subsequent Event | ||
Subsequent Event [Line Items] | ||
Number of positions overall headcount | position | 4 | |
Headcount reduction percentage | 13% | |
Restructuring costs, expected to be settled through future cash expenditures | $ 0.9 |