COVER
COVER - shares | 3 Months Ended | |
Mar. 31, 2023 | May 01, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2023 | |
Document Transition Report | false | |
Entity File Number | 001-39593 | |
Entity Registrant Name | Shattuck Labs, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 81-2575858 | |
Entity Address, Address Line One | 500 W. 5th Street | |
Entity Address, Address Line Two | Suite 1200 | |
Entity Address, City or Town | Austin | |
Entity Address, State or Province | TX | |
Entity Address, Postal Zip Code | 78701 | |
City Area Code | 512 | |
Local Phone Number | 900-4690 | |
Title of 12(b) Security | Common Stock, par value $0.0001 per share | |
Trading Symbol | STTK | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 42,471,288 | |
Entity Central Index Key | 0001680367 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q1 | |
Current Fiscal Year End Date | --12-31 |
CONDENSED BALANCE SHEETS
CONDENSED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 66,043 | $ 47,379 |
Investments | 69,452 | 113,901 |
Prepaid expenses and other current assets | 22,342 | 23,304 |
Total current assets | 157,837 | 184,584 |
Property and equipment, net | 16,887 | 17,671 |
Other assets | 2,953 | 3,069 |
Total assets | 177,677 | 205,324 |
Current liabilities: | ||
Accounts payable | 5,128 | 7,170 |
Accrued expenses and other current liabilities | 10,881 | 17,795 |
Total current liabilities | 16,009 | 24,965 |
Non-current operating lease liabilities | 4,014 | 4,202 |
Total liabilities | 20,023 | 29,167 |
Commitments and contingencies (Note 5) | ||
Stockholders’ equity: | ||
Common stock, $0.0001 par value: 300,000,000 shares authorized; 42,460,258 shares issued and outstanding at March 31, 2023 and 42,390,586 shares issued and outstanding at December 31, 2022 | 5 | 5 |
Additional paid-in capital | 397,724 | 396,041 |
Accumulated other comprehensive loss | (339) | (877) |
Accumulated deficit | (239,736) | (219,012) |
Total stockholders’ equity | 157,654 | 176,157 |
Total liabilities and stockholders’ equity | $ 177,677 | $ 205,324 |
CONDENSED BALANCE SHEETS - Pare
CONDENSED BALANCE SHEETS - Parenthetical - $ / shares | Mar. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 300,000,000 | 300,000,000 |
Common stock, shares issued (in shares) | 42,460,258 | 42,390,586 |
Common stock, shares outstanding (in shares) | 42,460,258 | 42,390,586 |
CONDENSED STATEMENTS OF OPERATI
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Income Statement [Abstract] | ||
Revenue from Contract with Customer, Product and Service [Extensible List] | License [Member] | License [Member] |
Collaboration revenue | $ 57 | $ 0 |
Operating expenses: | ||
Research and development | 16,667 | 19,187 |
General and administrative | 5,051 | 4,979 |
Expense from operations | 21,718 | 24,166 |
Loss from operations | (21,661) | (24,166) |
Other income (expense) | 937 | (362) |
Net loss | (20,724) | (24,528) |
Unrealized gain on investments | 538 | 33 |
Comprehensive loss | $ (20,186) | $ (24,495) |
Net loss per share – basic (in dollars per share) | $ (0.49) | $ (0.58) |
Net loss per share – diluted (in dollars per share) | $ (0.49) | $ (0.58) |
Weighted-average shares outstanding – basic (in shares) | 42,439,204 | 42,357,625 |
Weighted-average shares outstanding – diluted (in shares) | 42,439,204 | 42,357,625 |
CONDENSED STATEMENTS OF CHANGES
CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Gain (Loss) | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2021 | 42,338,898 | ||||
Beginning balance at Dec. 31, 2021 | $ 271,786 | $ 5 | $ 389,408 | $ (560) | $ (117,067) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Exercise of stock options and purchases pursuant to employee stock purchase plan (in shares) | 39,616 | ||||
Exercise of stock options and purchases pursuant to employee stock purchase plan | 134 | 134 | |||
Stock-based compensation expense | 1,513 | 1,513 | |||
Unrealized gain on investments | 33 | 33 | |||
Net loss | (24,528) | (24,528) | |||
Ending balance (in shares) at Mar. 31, 2022 | 42,378,514 | ||||
Ending balance at Mar. 31, 2022 | 248,938 | $ 5 | 391,055 | (527) | (141,595) |
Beginning balance (in shares) at Dec. 31, 2022 | 42,390,586 | ||||
Beginning balance at Dec. 31, 2022 | 176,157 | $ 5 | 396,041 | (877) | (219,012) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Exercise of stock options and purchases pursuant to employee stock purchase plan (in shares) | 11,888 | ||||
Exercise of stock options and purchases pursuant to employee stock purchase plan | $ 39 | 39 | |||
Issuance of common stock upon settlement of restricted stock units (in shares) | 73,937 | ||||
Shares withheld related to net share settlement (in shares) | (16,153) | ||||
Shares withheld related to net share settlement | $ (39) | (39) | |||
Stock-based compensation expense | 1,683 | 1,683 | |||
Unrealized gain on investments | 538 | 538 | |||
Net loss | (20,724) | (20,724) | |||
Ending balance (in shares) at Mar. 31, 2023 | 42,460,258 | ||||
Ending balance at Mar. 31, 2023 | $ 157,654 | $ 5 | $ 397,724 | $ (339) | $ (239,736) |
CONDENSED STATEMENTS OF CASH FL
CONDENSED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (20,724) | $ (24,528) |
Adjustments to reconcile net loss to net cash used in operations: | ||
Stock-based compensation | 1,683 | 1,513 |
Depreciation | 1,014 | 472 |
Non-cash operating lease expense | 85 | 65 |
Net amortization (accretion) of investments | (213) | 981 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 1,462 | 3,699 |
Other assets | 30 | 25 |
Accounts payable | (2,197) | (7,738) |
Accrued expenses and other current liabilities | (7,356) | (601) |
Non-current operating lease liabilities | (188) | (165) |
Deferred revenue | (57) | 0 |
Net cash used in operating activities | (26,461) | (26,277) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (75) | (2,488) |
Net change in investments | 45,200 | (12,894) |
Net cash provided by (used in) investing activities | 45,125 | (15,382) |
Cash flows from financing activities: | ||
Proceeds from the exercises of stock options and purchases pursuant to employee stock purchase plan | 39 | 134 |
Taxes paid related to net share settlement of equity awards | (39) | 0 |
Net cash provided by financing activities | 0 | 134 |
Net increase (decrease) in cash and cash equivalents | 18,664 | (41,525) |
Cash and cash equivalents, beginning of period | 47,379 | 92,268 |
Cash and cash equivalents, end of period | 66,043 | 50,743 |
Supplemental disclosures of non-cash financial activities: | ||
Operating lease liabilities recognized for operating right-of-use assets | 0 | 5,447 |
Operating right-of-use assets exchanged for operating lease liabilities | 0 | 2,945 |
Deferred revenue billed but not received | 500 | 0 |
Unpaid amounts related to purchases of property and equipment | $ 155 | $ 319 |
Organization and Description of
Organization and Description of Business | 3 Months Ended |
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Description of Business | Organization and Description of Business Shattuck Labs, Inc. (the “Company”) was incorporated in 2016 in the State of Delaware and is a clinical-stage biopharmaceutical company developing dual-sided fusion proteins, including its Agonist Redirected Checkpoint (“ARC ® ”) and gamma delta T cell engager (“GADLEN ™ ”) platforms, as novel classes of biologic medicines capable of multifunctional activity with potential applications in oncology and inflammatory diseases. Using its proprietary technology, the Company is building a pipeline of therapeutics, initially focused on the treatment of solid tumors and hematologic malignancies. The Company has one clinical-stage product candidate, SL-172154, and has several compounds in preclinical development. Liquidity The Company has incurred losses and negative cash flows from operations since inception and has an accumulated deficit of $239.7 million as of March 31, 2023. The Company anticipates incurring additional losses and negative cash flows from operations until such time, if ever, that it can generate significant sales of its product candidates currently in development, and is highly dependent on its ability to find additional sources of funding in the form of licensing of its technology, collaboration agreements and/or public and private debt and equity financings. Adequate additional funding may not be available to the Company on acceptable terms, or at all. The failure to raise funds as and when needed could have a negative impact on the Company’s financial condition and ability to pursue its clinical operations, research and development and commercialization of its product candidates. Management believes that the Company’s cash and cash equivalents and investments of $135.5 million as of March 31, 2023 are sufficient to fund projected operations of the Company for at least the next twelve months. Global Economic Considerations In addition, the global macroeconomic environment is uncertain, and could be negatively affected by, among other things, increased U.S. trade tariffs and trade disputes with other countries, instability in the global capital and credit markets, supply chain weaknesses, instability in the geopolitical environment, including as a result of the Russian invasion of Ukraine and other political tensions, and lingering effects of the COVID-19 pandemic. Such challenges have caused, and may continue to cause, recession fears, rising interest rates, foreign exchange volatility and inflationary pressures. At this time, we are unable to quantify the potential effects of this economic instability on our future operations. |
Basis of Presentation and Summa
Basis of Presentation and Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Presentation and Summary of Significant Accounting Policies | Basis of Presentation and Summary of Significant Accounting Policies Basis of Presentation The accompanying unaudited interim condensed financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Unaudited Interim Condensed Financial Statements In the opinion of management, the accompanying interim financial statements include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the financial statements) considered necessary to present fairly the Company’s financial position, its results of operations, statements of changes in stockholders’ equity and cash flows for the interim periods presented. Operating results for interim periods presented are not necessarily indicative of the results that may be expected for the year ending December 31, 2023. The interim financial statements presented herein do not contain all required disclosures under GAAP for annual financial statements. The accompanying unaudited interim condensed financial statements should be read in conjunction with the annual audited financial statements and related notes in our Annual Report on Form 10-K for the year ended December 31, 2022. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Significant estimates and assumptions reflected in these financial statements include, but are not limited to, revenue recognition, the accrual of research and development expenses, and the valuation of stock-based awards. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Changes in estimates, if any, are recorded in the period in which they become known and actual results could differ from management’s estimates. Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business as one segment. Fair Value of Financial Instruments Fair value is defined as the price that would be received upon the sale of an asset or paid upon the transfer of a liability in an orderly transaction between market participants at the measurement date and in the principal or most advantageous market for that asset or liability. Fair value measurements are classified and disclosed in one of the following categories: • Level 1: Observable inputs such as quoted prices in active markets for identical assets the reporting entity has the ability to access as of the measurement date; • Level 2: Inputs, other than quoted prices in active markets, that are observable either directly or indirectly; and • Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions. Fair value measurements are classified based on the lowest level of input that is significant to the measurement. The Company’s assessment of the significance of a particular input to the fair value measurement requires judgment, which may affect the valuation of the assets and liabilities and their placement within the fair value hierarchy levels. The determination of the fair values stated below takes into account the market for its financial assets and liabilities, the associated credit risk and other factors as required. The Company considers active markets as those in which transactions for the assets or liabilities occur with sufficient frequency and volume to provide pricing information on an ongoing basis. Management believes that the carrying amounts of the Company’s financial instruments, including investments and accounts payable, approximate fair value due to the short-term nature of those instruments. Concentration of Risk Financial instruments that potentially subject the Company to concentrations of credit risk primarily consist of cash, cash equivalents and investments. The Company maintains its cash and cash equivalents at two accredited financial institutions in amounts that exceed federally-insured limits. While the Company has not experienced any losses, the recent failure of Silicon Valley Bank (“SVB”), at which the Company held cash, exposed the Company to significant credit risk prior to the completion by the Federal Deposit Insurance Corporation of the resolution of SVB in a manner that fully protected all depositors. The Company is in the process of transferring its cash to an alternate depository institution, the financial position of which management believes does not expose the Company to significant credit risk. Where possible, the Company will also continue to hold its excess cash in investments and money market accounts to further limit exposure. The Company does not believe that it is subject to other unusual credit risk beyond the normal credit risk associated with commercial banking relationships. The Company invests in only U.S. Treasury securities that management believes protects the Company from risk of default and impairment of value. The Company is highly dependent on a limited number of contract manufacturing organizations (“CMOs”) to supply drug products for its research and development activities of its programs, including clinical trials and non-clinical studies. These programs could be adversely affected by a significant interruption in the supply of such drug products. The Company is highly dependent on a limited number of contract research organizations (“CROs”) and third-party service providers to manage and support its clinical trials. These programs could be adversely affected by a significant disruption in services provided by these CROs and third parties. Cash and Cash Equivalents The Company considers all demand deposits with financial institutions and all highly liquid investments with original maturities of 90 days or less at the date of purchase to be cash and cash equivalents. Cash and cash equivalents consisted of $0.8 million held in operating accounts and $65.2 million held in money market funds as of March 31, 2023, and $3.5 million held in operating accounts and $43.9 million held in money market funds as of December 31, 2022. Investments The Company’s investments consist of highly-rated U.S. Treasury securities and have been classified as available-for-sale and are carried at estimated fair value as determined based upon quoted market prices. Management determines the appropriate classification of its investment securities at the time of purchase. The Company may hold securities with stated maturities greater than one year. All available-for-sale securities are considered available to support current operations and are classified as current assets. Credit impairments for available-for-sale securities are recorded through an allowance rather than a direct write-down of the security and are recorded through a charge to the statements of operations. Unrealized gains or losses not related to credit impairments are recorded in accumulated other comprehensive income (loss), a component of stockholders’ equity, until realized. The Company reviews available-for-sale debt securities for impairments related to credit losses and other factors each quarter. As of March 31, 2023 and December 31, 2022, there were no impairments related to credit losses of investments. Impairment of Long-Lived Assets Long-lived assets are reviewed for indications of possible impairment whenever events or changes in circumstance indicate that the carrying amount of an asset may not be recoverable. Recoverability is measured by comparison of the carrying amounts to the future undiscounted cash flows attributable to these assets. An impairment loss is recognized to the extent an asset group is not recoverable and the carrying amount exceeds the projected discounted future cash flows arising from these assets. There were no impairments of long-lived assets for the three months ended March 31, 2023 and 2022. Leases The Company determines if an arrangement is a lease at inception. Right-of-use (“ROU”) assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. The classification of the Company’s leases as operating or finance leases, along with the initial measurement and recognition of the associated ROU assets and lease liabilities, are performed at the lease commencement date. The measurement of lease liabilities is based on the present value of future lease payments over the lease term. As the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the lease commencement date in determining the present value of future lease payments. The ROU asset is based on the measurement of the lease liability and also includes any lease payments made prior to or on lease commencement and excludes lease incentives and initial direct costs incurred, as applicable. The lease terms may include options to extend or terminate the lease when it is reasonably certain the Company will exercise any such options. Rent expense for the Company’s operating leases is recognized on a straight-line basis over the lease term. The Company has elected to not apply the recognition requirement of Accounting Standards Codification (“ASC”) 842, Leases of the Financial Accounting Standards Board (“FASB”) to leases with a term of 12 months or less for all classes of assets. Commitments and Contingencies The Company follows ASC 450-20, Contingencies of the FASB to report accounting for contingencies. Certain conditions may exist as of the date the condensed financial statements are issued, which may result in a loss to the Company but which will only be resolved when one or more future events occur or fail to occur. The Company assesses such contingent liabilities, and such assessment inherently involves an exercise of judgment. In assessing loss contingencies related to legal proceedings that are pending against the Company or unasserted claims that may result in such proceedings, the Company evaluates the perceived merits of any legal proceedings or unasserted claims as well as the perceived merits of the amount of relief sought or expected to be sought therein. If the assessment of a contingency indicates that it is probable that a material loss has been incurred and the amount of the liability can be estimated, then the estimated liability would be accrued in the Company’s condensed financial statements. If the assessment indicates that a potential material loss contingency is not probable but is reasonably possible, or is probable but cannot be estimated, then the nature of the contingent liability, and an estimate of the range of possible losses, if determinable and material, would be disclosed. Loss contingencies considered remote are generally not disclosed unless they involve guarantees, in which case the guarantees would be disclosed. Revenue Recognition Collaboration revenue is recognized in accordance with ASC 606, Revenue from Contracts with Customers (“ASC 606”). Arrangements with collaborators may include licenses to intellectual property, research and development services, manufacturing services for clinical and commercial supply and participation on joint steering committees. The Company evaluates the promised goods or services in the contract to determine which promises, or group of promises, represent performance obligations. In contemplation of whether a promised good or service meets the criteria required of a performance obligation, the Company considers the stage of development of the underlying intellectual property, the capabilities and expertise of the customer relative to the underlying intellectual property and whether the promised goods or services are integral to or dependent on other promises in the contract. When accounting for an arrangement that contains multiple performance obligations, the Company must develop judgmental assumptions, which may include market conditions, reimbursement rates for personnel costs, development timelines and probabilities of regulatory success to determine the stand-alone selling price for each performance obligation identified in the contract. Upon the amendment of an existing agreement, the Company evaluates whether the amendment represents a modification to an existing contract that would be recorded through a cumulative catch-up to revenue, or a separate contract. If it is determined that it is a separate contract, the Company will evaluate the necessary revenue recognition through the five-step process described below. When the Company concludes that a contract should be accounted for as a combined performance obligation and recognized over time, the Company must then determine the period over which revenue should be recognized and the method by which to measure revenue. The Company generally recognizes revenue using a cost-based input method. The Company recognizes collaboration revenue in an amount that reflects the consideration that the Company expects to receive in exchange for those goods or services when its customer or collaborator obtains control of promised goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the following five steps are performed: i. identify the contract(s) with a customer; ii. identify the performance obligations in the contract; iii. determine the transaction price; iv. allocate the transaction price to the performance obligations within the contract; and v. recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it determines that it is probable it will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within the contract to determine whether each promised good or service is a performance obligation. The promised goods or services in the Company’s arrangements may consist of a license of, or options to license, the Company’s intellectual property and research, development and manufacturing services. The Company may provide options to additional items in such arrangements, which are accounted for as separate contracts when the customer elects to exercise such options, unless the option provides a material right to the customer. Performance obligations are promises in a contract to transfer a distinct good or service to the customer that (i) the customer can benefit from on its own or together with other readily available resources and (ii) are separately identifiable from other promises in the contract. Goods or services that are not individually distinct performance obligations are combined with other promised goods or services until such combined group of promises meet the requirements of a performance obligation. The Company determines transaction price based on the amount of consideration the Company expects to receive for transferring the promised goods or services in the contract. Consideration may be fixed, variable or a combination of both. At contract inception for arrangements that include variable consideration, the Company estimates the probability and extent of consideration it expects to receive under the contract utilizing either the most-likely amount method or expected amount method, whichever best estimates the amount expected to be received. The Company then considers any constraints on the variable consideration and includes variable consideration in the transaction price to the extent it is deemed 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. The Company then allocates the transaction price to each performance obligation based on the relative standalone selling price and recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) control is transferred to the customer and the performance obligation is satisfied. For performance obligations that consist of licenses and other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. The Company records amounts as accounts receivable when the right to consideration is deemed unconditional. When consideration is received, or such consideration is unconditionally due, from a customer prior to transferring goods or services to the customer under the terms of a contract, a contract liability is recorded as deferred revenue. Amounts received prior to satisfying the revenue recognition criteria are recognized as deferred revenue in the Company’s accompanying balance sheet. Deferred revenues expected to be recognized as revenue within the 12 months following the balance sheet date are classified as a current liability. Deferred revenues not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as non-current liabilities. The Company’s collaboration revenue arrangements may include the following: Up-front License Fees: If a license is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from nonrefundable, up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Milestone Payments: At the inception of an agreement that includes research and development milestone payments, the Company evaluates each milestone to determine when and how much of the milestone to include in the transaction price. The Company first estimates the amount of the milestone payment that the Company could receive using either the expected value or the most-likely amount approach. The Company primarily uses the most-likely amount approach as that approach is generally most predictive for milestone payments with a binary outcome. The Company then considers whether any portion of that estimated amount is subject to the variable consideration constraint (that is, whether it is probable that a significant reversal of cumulative revenue would not occur upon resolution of the uncertainty). The Company updates the estimate of variable consideration included in the transaction price at each reporting date which includes updating the assessment of the likely amount of consideration and the application of the constraint to reflect current facts and circumstances. Royalties: For arrangements that include sales-based royalties, including milestone payments based on a level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company will recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not granted a development and commercialization license nor recognized any revenue related to sales-based royalties or milestone payments based on the level of sales. Research and Development Services: The Company will record costs associated with development and process optimization activities as research and development expenses in the statements of operations and comprehensive loss consistent with ASC 730, Research and Development. The Company considered the guidance in ASC 808, Collaborative Arrangements and will recognize the payments received from these agreements as revenue when the related costs are incurred. Research and Development Costs Research and development costs are expensed as incurred, and include salaries, stock-based compensation and other personnel-related costs, equipment and supplies, depreciation, nonclinical studies, clinical trials and manufacturing development activities. A substantial portion of the Company’s ongoing research and development activities are conducted by third-party service providers, including CROs and CMOs. The Company accrues for expenses resulting from obligations under agreements with CROs, CMOs and other outside service providers for which payment flows do not match the periods over which materials or services are provided to the Company. Accruals are recorded based on estimates of services received and efforts expended pursuant to agreements established with CROs, CMOs and other outside service providers. These estimates are typically based on contracted amounts applied to the proportion of work performed and determined through an evaluation of the progress or stage of completion of the services. In the event advance payments are made to a CRO, CMO or outside service provider, the payments will be recorded as a prepaid asset, which will be amortized as the contracted services are performed. As actual costs become known, the Company adjusts its accruals and prepaid assets accordingly. Inputs, such as the services performed, the number of patients enrolled or the study duration, may vary from the Company’s estimates, resulting in adjustments to research and development expense in future periods. The Company makes significant judgments and estimates in determining the accrual and/or prepaid balance in each reporting period and changes in these estimates may result in material changes to the Company’s accruals that could materially affect the Company’s results of operations. Net Loss Per Share Basic loss per share of common stock is computed by dividing net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during each period. Diluted loss per share of common stock includes the effect, if any, from the potential exercise or conversion of securities, such as redeemable convertible preferred stock or convertible notes, if any, stock options and unvested shares of restricted stock, which would result in the issuance of incremental shares of common stock. For diluted net loss per share, the weighted-average number of shares of common stock is the same for basic net loss per share due to the fact that when a net loss exists, dilutive securities are not included in the calculation as the impact is anti-dilutive. The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares of common stock outstanding as of March 31, 2023 and 2022, as they would be anti-dilutive: Three Months Ended March 31, 2023 2022 Stock options 5,261,439 3,460,911 Unvested restricted stock 652,598 313,390 5,914,037 3,774,301 Other Comprehensive Income (Loss) Other comprehensive income (loss) is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources. Other comprehensive income (loss) is comprised of the net loss and unrealized gains and losses on investments. Recently Adopted Accounting Pronouncements None. |
Investments
Investments | 3 Months Ended |
Mar. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments | Investments The following table represents the Company’s available for sale investments by major security type (amounts in thousands): March 31, 2023 Amortized Gross Unrealized Loss Total Fair Value Investments: U.S. Treasury securities $ 69,791 $ (339) $ 69,452 Total investments $ 69,791 $ (339) $ 69,452 December 31, 2022 Amortized Gross Unrealized Loss Total Fair Value Investments: U.S. Treasury securities $ 114,778 $ (877) $ 113,901 Total investments $ 114,778 $ (877) $ 113,901 The Company’s investment instruments and cash and cash equivalents are classified using Level 1 inputs within the fair value hierarchy and are valued using quoted market prices, broker or dealer quotations, or alternative pricing sources with reasonable levels of price transparency. Debt securities have a weighted-average maturity of 0.24 years as of March 31, 2023. |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 3 Months Ended |
Mar. 31, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following (amounts in thousands): March 31, December 31, Research and development contract costs $ 6,650 $ 11,256 Litigation settlement 1,400 1,400 Compensation and related benefits 1,203 3,967 Other current liabilities 1,628 1,172 Total accrued expenses and other current liabilities $ 10,881 $ 17,795 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Operating Leases The Company leases certain office space, laboratory facilities, and equipment. These leases require monthly lease payments that may be subject to annual increases throughout the lease term. Certain of these leases also include renewal options at the election of the Company to renew or extend the lease. These optional periods have not been considered in the determination of the ROU assets or lease liabilities associated with these leases as the Company did not consider it reasonably certain it would exercise the options. The Company performed evaluations of its contracts and determined it has operating leases. There have been no material changes in our operating leases as compared to operating leases disclosed in our Annual Report on Form 10-K for the year ended December 31, 2022. Nighthawk Biosciences, Inc. License Agreement In connection with a license agreement with Nighthawk Biosciences, Inc. (“Nighthawk”), the Company is required to make payments of up to $20.6 million in aggregate for the achievement of specified development, regulatory and commercial sales milestones for certain licensed products. The Company paid $0.1 million to Nighthawk in the three months ended March 31, 2023 as a milestone payment for the Company’s completion of a Phase 1 clinical trial for SL-172154. The Company is required to pay Nighthawk a percentage of upfront fees or other non-royalty payments not tied to milestone events that it receives in connection with certain sublicenses of the licensed patents. The Company is also required to pay Nighthawk a royalty on all of its worldwide net sales, those of its affiliates, and sublicenses of certain licensed patents in the low single digits. The Company has not recorded a liability for the aforementioned payments given the achievement of specified development, regulatory and commercial sales milestones for certain licensed products is not probable as of the balance sheet date. Litigation From time to time, the Company may become involved in various legal actions arising in the ordinary course of business. On January 31, 2022 and February 11, 2022, putative class action lawsuits were filed in the U.S. District Court for the Eastern District of New York against us and certain of the Company’s officers and directors. The cases were consolidated on June 2, 2022, and the plaintiffs filed an amended complaint on July 1, 2022. The amended complaint cites the volatility in the Company’s common stock and alleges that the defendants made or are responsible for misleading omissions regarding the Company’s clinical trial results and the collaboration agreement with Millennium Pharmaceuticals, Inc., a wholly-owned subsidiary of Takeda Pharmaceutical Company, Ltd. The parties reached a settlement in principle of the plaintiffs’ claims in the amount of $1.4 million on November 2, 2022. The settlement is subject to a definitive settlement agreement, notice to stockholders and court approval. The parties filed their motion for preliminary approval of the settlement agreement with the court on December 14, 2022, and, as of May 8, 2023, that motion is pending. The Company has accrued the settlement amount in accrued expenses and other current liabilities as of March 31, 2023. Contractual Obligations |
Equity
Equity | 3 Months Ended |
Mar. 31, 2023 | |
Equity [Abstract] | |
Equity | EquityThe Company is authorized to issue up to 300,000,000 shares of common stock and 10,000,000 shares of preferred stock, all with a par value of $0.0001 per share. The holders of the Company’s common stock are entitled to one vote per share on all matters submitted to a vote of stockholders. The Company’s common stock is not entitled to preemptive rights, and is not subject to conversion, redemption or sinking fund provisions. Subject to preferences that may apply to any shares of preferred stock outstanding at the time, the holders of the Company’s common stock will receive ratably any dividends declared by the Company’s board of directors (“Board”) out of funds legally available. In the event of the Company’s liquidation, dissolution or winding-up, the holders of the Company’s common stock will be entitled to share ratably in all assets remaining after payment of or provision for any liabilities. As of the periods presented, no common stock dividends had been declared by the Board. At March 31, 2023, none of the 10,000,000 shares of preferred stock were outstanding, and the Company has no present plans to issue any shares of preferred stock. |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation 2020 Equity Incentive Plan In September 2020, the Company adopted the 2020 Stock Incentive Plan (the “2020 Plan”) which, as of the adoption date, replaced the 2016 Stock Incentive Plan. Under the 2020 Plan, the share reserve automatically increases on January 1st of each year beginning in 2021 and ending with a final increase on January 1, 2030 in an amount equal to 4% of the Company’s outstanding common shares on December 31st of the preceding calendar year. The Board may provide that there will be no increase in the share reserve for any such year or that the increase in the share reserve may be smaller than would otherwise occur. On January 1, 2023, the share reserve automatically increased by 1,695,623 shares. As of March 31, 2023, there were 3,739,124 shares available for future grants. The 2020 Plan permits the granting of options, stock appreciation rights, restricted stock units (“RSUs”), performance stock and performance cash awards. The terms of the agreements under the 2020 Plan are determined by the Board. The Company’s awards generally vest over four years and have a term of 10 years. In 2023, the Company granted 165,050 awards that vest in three equal tranches based on the Company achieving a certain closing share price for each tranche for 30 consecutive trading days on or before the four 2020 Employee Stock Purchase Plan The 2020 Employee Stock Purchase Plan (“2020 ESPP”) became effective in October 2020. A total of 395,795 shares of common stock were reserved for issuance under the 2020 ESPP. Eligible employees may purchase shares of common stock under the 2020 ESPP at 85% of the lower of the fair market value of the Company’s common stock as of the first or the last day of each offering period. Employees are limited to contributing 15% of the employee’s eligible compensation and may not purchase more than $25,000 of stock during any calendar year or more than 600 shares during any one purchase period. The 2020 ESPP share reserve automatically increases on January 1st of each calendar year, for ten years, commencing on January 1, 2021, in an amount equal to 1% of the total number of shares of common stock outstanding on December 31st of the preceding calendar year. The Board may act prior to January 1st of a given year to provide that there will be no January 1st increase of the share reserve for such year or that the increase in the share reserve for such year will be a smaller number of shares of common stock than would otherwise occur pursuant to the preceding sentence. On January 1, 2023, the share reserve increased by 423,905 shares. As of March 31, 2023, there were 1,216,723 shares available for future grants. During the three months ended March 31, 2023 and 2022, the Company issued 11,171 and 5,227 shares of common stock for aggregate cash proceeds of $0.1 million and $0.1 million, respectively. The Company recorded stock-based compensation expense in the following expense categories of its accompanying unaudited interim condensed statements of operations and comprehensive loss (in thousands): Three Months Ended March 31, 2023 2022 Research and development $ 814 $ 827 General and administrative 869 686 Total stock-based compensation $ 1,683 $ 1,513 The following table summarizes option activity under the 2020 Plan: Options Weighted Average Exercise Price Weighted Average Remaining Life (Years) Balance at December 31, 2022 4,209,255 $ 8.29 8.07 Granted 1,181,087 3.57 Exercised (717) 2.95 Forfeited (128,186) 7.57 Balance at March 31, 2023 5,261,439 $ 7.25 8.07 Vested and expected to vest 5,174,691 $ 7.27 8.05 Exercisable at the end of the period 2,122,655 $ 8.28 6.55 Options granted during the three months ended March 31, 2023 and 2022 had weighted-average grant-date fair values of $2.46 and $5.13 per share, respectively. As of March 31, 2023, the unrecognized compensation cost for options issued was $14.1 million and will be recognized over an estimated weighted-average amortization period of 2.49 years. The total intrinsic value of options exercised during the three months ended March 31, 2023 and 2022 was $0.1 million and $0.1 million, respectively. The aggregate intrinsic value of options outstanding and exercisable as of March 31, 2023 was $0.2 million. Restricted Stock Units The following table summarizes employee RSU activity for the three months ended March 31, 2023: Awards Weighted Average Grant Date Fair Value Unvested RSUs as of December 31, 2022 309,477 $ 7.22 Granted 445,025 3.57 Released (73,937) 7.43 Forfeited (27,967) 4.89 Balance at March 31, 2023 652,598 $ 4.81 The Company recognized $0.2 million of stock-based compensation related to RSUs as of March 31, 2023. As of March 31, 2023, the unrecognized compensation cost for RSUs issued was $3.1 million and will be recognized over an estimated weighted-average amortization period of 3.47 years. The fair values of RSUs are based on the fair value of the Company’s common stock on the date of the grant. Fair Value of Stock Options and Shares Issued The Company accounts for stock-based compensation by measuring and recognizing as compensation expense the fair value of all share-based payment awards made to employees, including employee stock options and restricted stock awards. The Company uses the Black-Scholes option pricing model to estimate the fair value of employee stock options that only have service or performance conditions. The Company uses the Monte Carlo pricing model to estimate the fair value of options that have market-based conditions. The inputs to both pricing models require a number of management estimates such as the expected term, volatility, risk-free interest rate and dividend yield. The fair value of stock options was determined using the methods and assumptions discussed below. • The expected term of employee stock options with service-based vesting is determined using the “simplified” method, whereby the expected life equals the arithmetic average of the vesting term and the original contractual term of the option due to the Company’s lack of sufficient historical data. • The expected stock price volatility assumption is based on the historical volatilities of the common stock of a peer group of publicly traded companies as well as the historical volatility of the Company’s common stock since the Company began trading subsequent to the Company’s initial public offering (“IPO”) in October 2020 over the period corresponding to the expected life as of the grant date. The historical volatility data was computed using the daily closing prices during the equivalent period of the calculated expected term of the stock-based awards. The Company will continue to apply this process until a sufficient amount of historical information regarding the volatility of the Company’s stock price becomes available, or until circumstances change, such that the identified entities are no longer comparable companies. In the latter case, other suitable, similar entities whose share prices are publicly available would be utilized in the calculation. • The risk-free interest rate is based on the interest rate payable on U.S. Treasury securities in effect at the time of grant for a period that is commensurate with the expected term. • The expected dividend yield is 0% because the Company has not historically paid, and does not expect, for the foreseeable future, to pay dividends on its common stock. • Prior to the Company’s IPO, the Board periodically estimated the fair value of the Company’s common stock considering, among other things, contemporaneous valuations of its common stock prepared by an unrelated third-party valuation firm. Subsequent to the Company’s IPO, options are issued with a strike price no less than the market price on date of grant. The grant-date fair value of options calculated using the Black-Scholes option pricing model granted under the Company’s 2020 Plan were estimated using the following weighted-average assumptions: Three Months Ended March 31, 2023 2022 2020 Plan Expected term - years 6.08 6.08 Expected volatility 84.8% 81.9% Risk-free interest rate 3.5% 1.6% Expected dividends — — The grant-date fair value of options calculated using the Monte Carlo option pricing model granted under the Company’s 2020 Plan were estimated using the following assumptions: Three Months Ended March 31, 2023 2022 2020 Plan Expected term - years 4.00 4.00 Expected volatility 80.0% 80.0% Risk-free interest rate 3.6% 1.4% Expected dividends — — The grant-date fair value of shares issued calculated using the Black-Scholes option pricing model under the Company’s 2020 ESPP were estimated using the following weighted-average assumptions: Three Months Ended March 31, 2023 2022 2020 ESPP Expected term - years 0.49 0.49 Expected volatility 84.8% 81.8% Risk-free interest rate 3.5% 2.0% Expected dividends — — |
Basis of Presentation and Sum_2
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Presentation and Unaudited Interim Condensed Financial Statements | Basis of Presentation The accompanying unaudited interim condensed financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Unaudited Interim Condensed Financial Statements |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Significant estimates and assumptions reflected in these financial statements include, but are not limited to, revenue recognition, |
Segment Information | Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business as one segment. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Fair value is defined as the price that would be received upon the sale of an asset or paid upon the transfer of a liability in an orderly transaction between market participants at the measurement date and in the principal or most advantageous market for that asset or liability. Fair value measurements are classified and disclosed in one of the following categories: • Level 1: Observable inputs such as quoted prices in active markets for identical assets the reporting entity has the ability to access as of the measurement date; • Level 2: Inputs, other than quoted prices in active markets, that are observable either directly or indirectly; and • Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions. Fair value measurements are classified based on the lowest level of input that is significant to the measurement. The Company’s assessment of the significance of a particular input to the fair value measurement requires judgment, which may affect the valuation of the assets and liabilities and their placement within the fair value hierarchy levels. The determination of the fair values stated below takes into account the market for its financial assets and liabilities, the associated credit risk and other factors as required. The Company considers active markets as those in which transactions for the assets or liabilities occur with sufficient frequency and volume to provide pricing information on an ongoing basis. Management believes that the carrying amounts of the Company’s financial instruments, including investments and accounts payable, approximate fair value due to the short-term nature of those instruments. |
Concentration of Risk | Concentration of Risk Financial instruments that potentially subject the Company to concentrations of credit risk primarily consist of cash, cash equivalents and investments. The Company maintains its cash and cash equivalents at two accredited financial institutions in amounts that exceed federally-insured limits. While the Company has not experienced any losses, the recent failure of Silicon Valley Bank (“SVB”), at which the Company held cash, exposed the Company to significant credit risk prior to the completion by the Federal Deposit Insurance Corporation of the resolution of SVB in a manner that fully protected all depositors. The Company is in the process of transferring its cash to an alternate depository institution, the financial position of which management believes does not expose the Company to significant credit risk. Where possible, the Company will also continue to hold its excess cash in investments and money market accounts to further limit exposure. The Company does not believe that it is subject to other unusual credit risk beyond the normal credit risk associated with commercial banking relationships. The Company invests in only U.S. Treasury securities that management believes protects the Company from risk of default and impairment of value. The Company is highly dependent on a limited number of contract manufacturing organizations (“CMOs”) to supply drug products for its research and development activities of its programs, including clinical trials and non-clinical studies. These programs could be adversely affected by a significant interruption in the supply of such drug products. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all demand deposits with financial institutions and all highly liquid investments with original maturities of 90 days or less at the date of purchase to be cash and cash equivalents. |
Investments | Investments The Company’s investments consist of highly-rated U.S. Treasury securities and have been classified as available-for-sale and are carried at estimated fair value as determined based upon quoted market prices. Management determines the appropriate classification of its investment securities at the time of purchase. The Company may hold securities with stated maturities greater than one year. All available-for-sale securities are considered available to support current operations and are classified as current assets. Credit impairments for available-for-sale securities are recorded through an allowance rather than a direct write-down of the security and are recorded through a charge to the statements of operations. Unrealized gains or losses not related to credit impairments are recorded in accumulated other comprehensive income (loss), a component of stockholders’ equity, until realized. The Company reviews available-for-sale debt securities for impairments related to credit losses and other factors each quarter. |
Impairment of Long-Lived Assets | Impairment of Long-Lived AssetsLong-lived assets are reviewed for indications of possible impairment whenever events or changes in circumstance indicate that the carrying amount of an asset may not be recoverable. Recoverability is measured by comparison of the carrying amounts to the future undiscounted cash flows attributable to these assets. An impairment loss is recognized to the extent an asset group is not recoverable and the carrying amount exceeds the projected discounted future cash flows arising from these assets. |
Leases | Leases The Company determines if an arrangement is a lease at inception. Right-of-use (“ROU”) assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. The classification of the Company’s leases as operating or finance leases, along with the initial measurement and recognition of the associated ROU assets and lease liabilities, are performed at the lease commencement date. The measurement of lease liabilities is based on the present value of future lease payments over the lease term. As the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the lease commencement date in determining the present value of future lease payments. The ROU asset is based on the measurement of the lease liability and also includes any lease payments made prior to or on lease commencement and excludes lease incentives and initial direct costs incurred, as applicable. The lease terms may include options to extend or terminate the lease when it is reasonably certain the Company will exercise any such options. Rent expense for the Company’s operating leases is recognized on a straight-line basis over the lease term. The Company has elected to not apply the recognition requirement of Accounting Standards Codification (“ASC”) 842, Leases of the Financial Accounting Standards Board (“FASB”) to leases with a term of 12 months or less for all classes of assets. |
Commitments and Contingencies | Commitments and Contingencies The Company follows ASC 450-20, Contingencies of the FASB to report accounting for contingencies. Certain conditions may exist as of the date the condensed financial statements are issued, which may result in a loss to the Company but which will only be resolved when one or more future events occur or fail to occur. The Company assesses such contingent liabilities, and such assessment inherently involves an exercise of judgment. In assessing loss contingencies related to legal proceedings that are pending against the Company or unasserted claims that may result in such proceedings, the Company evaluates the perceived merits of any legal proceedings or unasserted claims as well as the perceived merits of the amount of relief sought or expected to be sought therein. If the assessment of a contingency indicates that it is probable that a material loss has been incurred and the amount of the liability can be estimated, then the estimated liability would be accrued in the Company’s condensed financial statements. If the assessment indicates that a potential material loss contingency is not probable but is reasonably possible, or is probable but cannot be estimated, then the nature of the contingent liability, and an estimate of the range of possible losses, if determinable and material, would be disclosed. Loss contingencies considered remote are generally not disclosed unless they involve guarantees, in which case the guarantees would be disclosed. |
Revenue Recognition | Revenue Recognition Collaboration revenue is recognized in accordance with ASC 606, Revenue from Contracts with Customers (“ASC 606”). Arrangements with collaborators may include licenses to intellectual property, research and development services, manufacturing services for clinical and commercial supply and participation on joint steering committees. The Company evaluates the promised goods or services in the contract to determine which promises, or group of promises, represent performance obligations. In contemplation of whether a promised good or service meets the criteria required of a performance obligation, the Company considers the stage of development of the underlying intellectual property, the capabilities and expertise of the customer relative to the underlying intellectual property and whether the promised goods or services are integral to or dependent on other promises in the contract. When accounting for an arrangement that contains multiple performance obligations, the Company must develop judgmental assumptions, which may include market conditions, reimbursement rates for personnel costs, development timelines and probabilities of regulatory success to determine the stand-alone selling price for each performance obligation identified in the contract. Upon the amendment of an existing agreement, the Company evaluates whether the amendment represents a modification to an existing contract that would be recorded through a cumulative catch-up to revenue, or a separate contract. If it is determined that it is a separate contract, the Company will evaluate the necessary revenue recognition through the five-step process described below. When the Company concludes that a contract should be accounted for as a combined performance obligation and recognized over time, the Company must then determine the period over which revenue should be recognized and the method by which to measure revenue. The Company generally recognizes revenue using a cost-based input method. The Company recognizes collaboration revenue in an amount that reflects the consideration that the Company expects to receive in exchange for those goods or services when its customer or collaborator obtains control of promised goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the following five steps are performed: i. identify the contract(s) with a customer; ii. identify the performance obligations in the contract; iii. determine the transaction price; iv. allocate the transaction price to the performance obligations within the contract; and v. recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it determines that it is probable it will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within the contract to determine whether each promised good or service is a performance obligation. The promised goods or services in the Company’s arrangements may consist of a license of, or options to license, the Company’s intellectual property and research, development and manufacturing services. The Company may provide options to additional items in such arrangements, which are accounted for as separate contracts when the customer elects to exercise such options, unless the option provides a material right to the customer. Performance obligations are promises in a contract to transfer a distinct good or service to the customer that (i) the customer can benefit from on its own or together with other readily available resources and (ii) are separately identifiable from other promises in the contract. Goods or services that are not individually distinct performance obligations are combined with other promised goods or services until such combined group of promises meet the requirements of a performance obligation. The Company determines transaction price based on the amount of consideration the Company expects to receive for transferring the promised goods or services in the contract. Consideration may be fixed, variable or a combination of both. At contract inception for arrangements that include variable consideration, the Company estimates the probability and extent of consideration it expects to receive under the contract utilizing either the most-likely amount method or expected amount method, whichever best estimates the amount expected to be received. The Company then considers any constraints on the variable consideration and includes variable consideration in the transaction price to the extent it is deemed 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. The Company then allocates the transaction price to each performance obligation based on the relative standalone selling price and recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) control is transferred to the customer and the performance obligation is satisfied. For performance obligations that consist of licenses and other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. The Company records amounts as accounts receivable when the right to consideration is deemed unconditional. When consideration is received, or such consideration is unconditionally due, from a customer prior to transferring goods or services to the customer under the terms of a contract, a contract liability is recorded as deferred revenue. Amounts received prior to satisfying the revenue recognition criteria are recognized as deferred revenue in the Company’s accompanying balance sheet. Deferred revenues expected to be recognized as revenue within the 12 months following the balance sheet date are classified as a current liability. Deferred revenues not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as non-current liabilities. The Company’s collaboration revenue arrangements may include the following: Up-front License Fees: If a license is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from nonrefundable, up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Milestone Payments: At the inception of an agreement that includes research and development milestone payments, the Company evaluates each milestone to determine when and how much of the milestone to include in the transaction price. The Company first estimates the amount of the milestone payment that the Company could receive using either the expected value or the most-likely amount approach. The Company primarily uses the most-likely amount approach as that approach is generally most predictive for milestone payments with a binary outcome. The Company then considers whether any portion of that estimated amount is subject to the variable consideration constraint (that is, whether it is probable that a significant reversal of cumulative revenue would not occur upon resolution of the uncertainty). The Company updates the estimate of variable consideration included in the transaction price at each reporting date which includes updating the assessment of the likely amount of consideration and the application of the constraint to reflect current facts and circumstances. Royalties: For arrangements that include sales-based royalties, including milestone payments based on a level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company will recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not granted a development and commercialization license nor recognized any revenue related to sales-based royalties or milestone payments based on the level of sales. Research and Development Services: The Company will record costs associated with development and process optimization activities as research and development expenses in the statements of operations and comprehensive loss consistent with ASC 730, Research and Development. The Company considered the guidance in ASC 808, Collaborative Arrangements |
Research and Development Costs | Research and Development Costs Research and development costs are expensed as incurred, and include salaries, stock-based compensation and other personnel-related costs, equipment and supplies, depreciation, nonclinical studies, clinical trials and manufacturing development activities. |
Net Loss Per Share | Net Loss Per Share Basic loss per share of common stock is computed by dividing net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during each period. Diluted loss per share of common stock includes the effect, if any, from the potential exercise or conversion of securities, such as redeemable convertible preferred stock or convertible notes, if any, stock options and unvested shares of restricted stock, which would result in the issuance of incremental shares of common stock. For diluted net loss per share, the weighted-average number of shares of common stock is the same for basic net loss per share due to the fact that when a net loss exists, dilutive securities are not included in the calculation as the impact is anti-dilutive. |
Other Comprehensive Income (Loss) | Other Comprehensive Income (Loss) Other comprehensive income (loss) is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources. Other comprehensive income (loss) is comprised of the net loss and unrealized gains and losses on investments. |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements None. |
Basis of Presentation and Sum_3
Basis of Presentation and Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of antidilutive securities excluded from computation of net loss per share | The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares of common stock outstanding as of March 31, 2023 and 2022, as they would be anti-dilutive: Three Months Ended March 31, 2023 2022 Stock options 5,261,439 3,460,911 Unvested restricted stock 652,598 313,390 5,914,037 3,774,301 |
Investments (Tables)
Investments (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of investments | The following table represents the Company’s available for sale investments by major security type (amounts in thousands): March 31, 2023 Amortized Gross Unrealized Loss Total Fair Value Investments: U.S. Treasury securities $ 69,791 $ (339) $ 69,452 Total investments $ 69,791 $ (339) $ 69,452 December 31, 2022 Amortized Gross Unrealized Loss Total Fair Value Investments: U.S. Treasury securities $ 114,778 $ (877) $ 113,901 Total investments $ 114,778 $ (877) $ 113,901 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of accrued expenses and other current liabilities | Accrued expenses and other current liabilities consisted of the following (amounts in thousands): March 31, December 31, Research and development contract costs $ 6,650 $ 11,256 Litigation settlement 1,400 1,400 Compensation and related benefits 1,203 3,967 Other current liabilities 1,628 1,172 Total accrued expenses and other current liabilities $ 10,881 $ 17,795 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of stock-based compensation expense | The Company recorded stock-based compensation expense in the following expense categories of its accompanying unaudited interim condensed statements of operations and comprehensive loss (in thousands): Three Months Ended March 31, 2023 2022 Research and development $ 814 $ 827 General and administrative 869 686 Total stock-based compensation $ 1,683 $ 1,513 |
Schedule of option activity | The following table summarizes option activity under the 2020 Plan: Options Weighted Average Exercise Price Weighted Average Remaining Life (Years) Balance at December 31, 2022 4,209,255 $ 8.29 8.07 Granted 1,181,087 3.57 Exercised (717) 2.95 Forfeited (128,186) 7.57 Balance at March 31, 2023 5,261,439 $ 7.25 8.07 Vested and expected to vest 5,174,691 $ 7.27 8.05 Exercisable at the end of the period 2,122,655 $ 8.28 6.55 |
Schedule of RSU activity | The following table summarizes employee RSU activity for the three months ended March 31, 2023: Awards Weighted Average Grant Date Fair Value Unvested RSUs as of December 31, 2022 309,477 $ 7.22 Granted 445,025 3.57 Released (73,937) 7.43 Forfeited (27,967) 4.89 Balance at March 31, 2023 652,598 $ 4.81 |
Schedule of valuation assumptions | The grant-date fair value of options calculated using the Black-Scholes option pricing model granted under the Company’s 2020 Plan were estimated using the following weighted-average assumptions: Three Months Ended March 31, 2023 2022 2020 Plan Expected term - years 6.08 6.08 Expected volatility 84.8% 81.9% Risk-free interest rate 3.5% 1.6% Expected dividends — — The grant-date fair value of options calculated using the Monte Carlo option pricing model granted under the Company’s 2020 Plan were estimated using the following assumptions: Three Months Ended March 31, 2023 2022 2020 Plan Expected term - years 4.00 4.00 Expected volatility 80.0% 80.0% Risk-free interest rate 3.6% 1.4% Expected dividends — — The grant-date fair value of shares issued calculated using the Black-Scholes option pricing model under the Company’s 2020 ESPP were estimated using the following weighted-average assumptions: Three Months Ended March 31, 2023 2022 2020 ESPP Expected term - years 0.49 0.49 Expected volatility 84.8% 81.8% Risk-free interest rate 3.5% 2.0% Expected dividends — — |
Organization and Description _2
Organization and Description of Business (Details) $ in Thousands | Mar. 31, 2023 USD ($) candidate | Dec. 31, 2022 USD ($) |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Number of clinical-stage product candidate | candidate | 1 | |
Accumulated deficit | $ 239,736 | $ 219,012 |
Cash, cash equivalents, and short-term investments | $ 135,500 |
Basis of Presentation and Sum_4
Basis of Presentation and Summary of Significant Accounting Policies - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Cash and Cash Equivalents [Line Items] | |||
Cash and cash equivalents | $ 66,043 | $ 47,379 | |
Impairment of long-lived assets | 0 | $ 0 | |
Operating Account | |||
Cash and Cash Equivalents [Line Items] | |||
Cash and cash equivalents | 800 | 3,500 | |
Money Market Funds | |||
Cash and Cash Equivalents [Line Items] | |||
Cash and cash equivalents | $ 65,200 | $ 43,900 |
Basis of Presentation and Sum_5
Basis of Presentation and Summary of Significant Accounting Policies - Schedule of anti-dilutive securities (Details) - shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of net loss per share (in shares) | 5,914,037 | 3,774,301 |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of net loss per share (in shares) | 5,261,439 | 3,460,911 |
Unvested restricted stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of net loss per share (in shares) | 652,598 | 313,390 |
Investments - Schedule of avail
Investments - Schedule of available for sale investments (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Investments: | ||
Amortized Cost | $ 69,791 | $ 114,778 |
Gross Unrealized Loss | (339) | (877) |
Total Fair Value | 69,452 | 113,901 |
U.S. Treasury securities | ||
Investments: | ||
Amortized Cost | 69,791 | 114,778 |
Gross Unrealized Loss | (339) | (877) |
Total Fair Value | $ 69,452 | $ 113,901 |
Investments - Narrative (Detail
Investments - Narrative (Details) | Mar. 31, 2023 |
Investments, Debt and Equity Securities [Abstract] | |
Debt securities, average maturity term | 2 months 26 days |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities - Schedule of accrued expenses and other current liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Research and development contract costs | $ 6,650 | $ 11,256 |
Litigation settlement | 1,400 | 1,400 |
Compensation and related benefits | 1,203 | 3,967 |
Other current liabilities | 1,628 | 1,172 |
Accrued expenses and other current liabilities | $ 10,881 | $ 17,795 |
Commitments and Contingencies -
Commitments and Contingencies - Narrative (Details) - USD ($) | 3 Months Ended | |
Nov. 02, 2022 | Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | ||
License agreement, maximum payment | $ 20,600,000 | |
Payments for royalties | 100,000 | |
Accrued royalty | $ 0 | |
Litigation settlement, amount awarded to other party | $ 1,400,000 |
Equity (Details)
Equity (Details) - $ / shares | Mar. 31, 2023 | Dec. 31, 2022 |
Equity [Abstract] | ||
Common stock, shares authorized (in shares) | 300,000,000 | 300,000,000 |
Preferred stock, shares authorized (in shares) | 10,000,000 | |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, par value (in dollars per share) | $ 0.0001 | |
Preferred stock, shares outstanding (in shares) | 0 |
Stock-Based Compensation - Narr
Stock-Based Compensation - Narrative (Details) $ / shares in Units, $ in Thousands | 3 Months Ended | |||||
Jan. 01, 2023 shares | Jan. 01, 2021 | Oct. 14, 2020 USD ($) shares | Mar. 31, 2023 USD ($) tranch $ / shares shares | Mar. 31, 2022 USD ($) $ / shares shares | Sep. 30, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Grant date fair value (in dollars per share) | $ / shares | $ 2.46 | $ 5.13 | ||||
Unrecognized compensation cost | $ 14,100 | |||||
Intrinsic value of options exercised | 100 | $ 100 | ||||
Aggregate intrinsic value of options exercisable | 200 | |||||
Aggregate intrinsic value of options outstanding | 200 | |||||
Total stock-based compensation | $ 1,683 | $ 1,513 | ||||
Stock options | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Weighted-average amortization period | 2 years 5 months 26 days | |||||
Expected dividends | 0% | |||||
Restricted Stock Units (RSUs) | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Weighted-average amortization period | 3 years 5 months 19 days | |||||
Total stock-based compensation | $ 200 | |||||
Unrecognized compensation cost for RSU | $ 3,100 | |||||
2020 Stock Incentive Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Increase in number of shares authorized, percentage of capital stock outstanding | 0.04 | |||||
Common stock, additional capital shares reserved for future issuance (in shares) | shares | 1,695,623 | |||||
Shares reserved for future issuance | shares | 3,739,124 | |||||
Stock-based compensation, vesting period | 4 years | |||||
Share-based compensation, expiration period | 10 years | |||||
Share-based payment award, grants in period (in shares) | shares | 165,050 | |||||
Number of tranches | tranch | 3 | |||||
Threshold consecutive trading days | 30 days | |||||
2020 Employee Stock Purchase Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Increase in number of shares authorized, percentage of capital stock outstanding | 0.01 | |||||
Common stock, additional capital shares reserved for future issuance (in shares) | shares | 423,905 | |||||
Shares reserved for future issuance | shares | 395,795 | 1,216,723 | ||||
Purchase price of common stock in percent | 85% | |||||
Contribution limit in percentage of employee's eligible compensation | 15% | |||||
Maximum value of shares per employee during any calendar year | $ 25 | |||||
Maximum number of shares per employee during any one purchase period (in shares) | shares | 600 | |||||
Annual increase in number of shares authorized, term | 10 years | |||||
Stock issued under ESPP (in shares) | shares | 11,171 | 5,227 | ||||
Proceeds from ESPP | $ 100 | $ 100 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of stock-based compensation expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation | $ 1,683 | $ 1,513 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation | 814 | 827 |
General and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation | $ 869 | $ 686 |
Stock-Based Compensation - Sc_2
Stock-Based Compensation - Schedule of option activity (Details) - $ / shares | 3 Months Ended | 12 Months Ended |
Mar. 31, 2023 | Dec. 31, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding [Roll Forward] | ||
Options, beginning balance (in shares) | 4,209,255 | |
Options, granted (in shares) | 1,181,087 | |
Options, exercised (in shares) | (717) | |
Options, forfeited (in shares) | (128,186) | |
Options, ending balance (in shares) | 5,261,439 | 4,209,255 |
Options, vested and expected to vest (in shares) | 5,174,691 | |
Options, exercisable (in shares) | 2,122,655 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Exercise Price [Abstract] | ||
Weighted average exercise price, beginning balance (in dollars per share) | $ 8.29 | |
Weighted average exercise price, granted (in dollars per share) | 3.57 | |
Weighted average exercise price, exercised (in dollars per share) | 2.95 | |
Weighted average exercise price, forfeited (in dollars per share) | 7.57 | |
Weighted average exercise price, ending balance (in dollars per share) | 7.25 | $ 8.29 |
Weighted average exercise price, vested and expected to vest (in dollars per share) | 7.27 | |
Weighted average exercise price, exercisable (in dollars per share) | $ 8.28 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Additional Disclosures [Abstract] | ||
Weighted average remaining contract life, outstanding | 8 years 25 days | 8 years 25 days |
Weighted average remaining contract life, vested and expected to vest | 8 years 18 days | |
Weighted average remaining contract life, exercisable | 6 years 6 months 18 days |
Stock-Based Compensation - Sc_3
Stock-Based Compensation - Schedule of restricted stock activity (Details) - Restricted Stock Units (RSUs) | 3 Months Ended |
Mar. 31, 2023 $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | |
Awards, beginning balance (in shares) | shares | 309,477 |
Granted (in shares) | shares | 445,025 |
Awards, vested (in shares) | shares | (73,937) |
Forfeited (in shares) | shares | (27,967) |
Awards, ending balance (in shares) | shares | 652,598 |
Weighted Average Grant Date Fair Value | |
Beginning balance (in dollars per share) | $ / shares | $ 7.22 |
Granted (in dollars per share) | $ / shares | 3.57 |
Vested (in dollars per share) | $ / shares | 7.43 |
Forfeited (in dollars per share) | $ / shares | 4.89 |
Ending balance (in dollars per share) | $ / shares | $ 4.81 |
Stock-Based Compensation - Sc_4
Stock-Based Compensation - Schedule of valuation assumptions (Details) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Stock options | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected dividends | 0% | |
Stock options | 2020 Stock Incentive Plan | Black-Scholes Option Pricing Model | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term - years | 6 years 29 days | 6 years 29 days |
Expected volatility | 84.80% | 81.90% |
Risk-free interest rate | 3.50% | 1.60% |
Expected dividends | 0% | 0% |
Stock options | 2020 Stock Incentive Plan | Monte Carlo Option Pricing Model | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term - years | 4 years | 4 years |
Expected volatility | 80% | 80% |
Risk-free interest rate | 3.60% | 1.40% |
Expected dividends | 0% | 0% |
ESPP | 2020 Employee Stock Purchase Plan | Black-Scholes Option Pricing Model | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term - years | 5 months 26 days | 5 months 26 days |
Expected volatility | 84.80% | 81.80% |
Risk-free interest rate | 3.50% | 2% |
Expected dividends | 0% | 0% |