Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Feb. 24, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2021 | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Entity Trading Symbol | VRCA | ||
Entity Interactive Data Current | Yes | ||
Entity Registrant Name | Verrica Pharmaceuticals Inc. | ||
Entity Central Index Key | 0001660334 | ||
Entity Current Reporting Status | Yes | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Public Float | $ 185.6 | ||
Entity Common Stock, Shares Outstanding | 27,519,053 | ||
Entity Shell Company | false | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transaction Period | true | ||
ICFR Auditor Attestation Flag | false | ||
Entity File Number | 001-38529 | ||
Entity Tax Identification Number | 46-3137900 | ||
Title of 12(b) Security | Common Stock, $0.0001 par value | ||
Security Exchange Name | NASDAQ | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Address, Address Line One | 44 West Gay Street | ||
Entity Address, Address Line Two | Suite 400 | ||
Entity Address, City or Town | West Chester | ||
Entity Address, State or Province | PA | ||
Entity Address, Postal Zip Code | 19380 | ||
City Area Code | 484 | ||
Local Phone Number | 453-3300 | ||
Documents Incorporated by Reference | DOCUMENTS INCORPORATED BY REFERENCE Portions of the registrant’s definitive proxy statement, to be filed pursuant to Regulation 14A under the Securities Exchange Act of 1934, for its 2022 Annual Meeting of Stockholders are incorporated by reference in Part III of this Form 10-K. | ||
Auditor Name | KPMG LLP | ||
Auditor Location | Philadelphia, PA | ||
Auditor Firm ID | 185 |
BALANCE SHEETS
BALANCE SHEETS - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 15,752,000 | $ 10,686,000 |
Marketable securities | 54,602,000 | 54,784,000 |
Prepaid expenses and other assets | 3,974,000 | 2,180,000 |
Total current assets | 74,328,000 | 67,650,000 |
Property and equipment, net | 3,894,000 | 3,102,000 |
Operating lease right-of-use asset | 1,608,000 | 1,836,000 |
Other non-current assets | 295,000 | 1,566,000 |
Total assets | 80,125,000 | 74,154,000 |
Current liabilities: | ||
Accounts payable | 845,000 | 348,000 |
Accrued expenses and other current liabilities | 3,266,000 | 3,114,000 |
Operating lease liability | 244,600 | 198,000 |
Financing lease liability | 6,000 | |
Deferred revenue | 500,000 | |
Debt, net | 41,693,000 | 35,315,000 |
Total current liabilities | 46,055,000 | 39,475,000 |
Operating lease liability | 1,449,000 | 1,693,000 |
Financing lease liability | 16,000 | |
Total liabilities | 47,520,000 | 41,168,000 |
Stockholders’ equity: | ||
Common stock, $0.0001 par value; 200,000,000 authorized as of December 31, 2020 and 2019; 25,546,257 shares issued and 25,441,113 shares outstanding as of December 31, 2020 and 25,912,137 shares issued and 25,786,330 shares outstanding as of December 31, 2019 | 3,000 | 3,000 |
Additional paid-in capital | 171,597,000 | 136,868,000 |
Accumulated deficit | (138,966,000) | (103,886,000) |
Accumulated other comprehensive (loss) gain | (29,000) | 1,000 |
Total stockholders’ equity | 32,605,000 | 32,986,000 |
Total liabilities and stockholders’ equity | $ 80,125,000 | $ 74,154,000 |
BALANCE SHEETS (Parenthetical)
BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 27,624,197 | 25,546,257 |
Common stock, shares outstanding | 27,519,053 | 25,441,113 |
Treasury stock, shares | 105,144 | 105,144 |
STATEMENTS OF OPERATIONS AND CO
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Statement [Abstract] | ||
License revenue | $ 12,000 | |
Revenue from Contract with Customer, Product and Service [Extensible List] | us-gaap:LicenseMember | us-gaap:LicenseMember |
Operating expenses: | ||
Research and development | $ 15,929 | $ 15,673 |
General and administrative | 26,979 | 24,508 |
Total operating expenses | 42,908 | 40,181 |
Loss from operations | (30,908) | (40,181) |
Other income (expense): | ||
Interest income | 123 | 521 |
Interest expense | (4,295) | (3,034) |
Total other expense | (4,172) | (2,513) |
Net loss | $ (35,080) | $ (42,694) |
Net loss per share, basic and diluted | $ (1.30) | $ (1.71) |
Weighted-average common shares outstanding, basic and diluted | 27,044,462 | 24,995,556 |
Other comprehensive loss: | ||
Unrealized loss on marketable securities | $ (30) | $ (19) |
Comprehensive loss | $ (35,110) | $ (42,713) |
STATEMENTS OF STOCKHOLDERS' EQU
STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-In Capital [Member] | Subscription Receivable [Member] | Accumulated Deficit [Member] | Treasury Stock [Member] | Accumulated Other Comprehensive (Loss) Gain [Member] |
Beginning Balance at Dec. 31, 2019 | $ 65,015 | $ 3 | $ 126,594 | $ (410) | $ (61,192) | $ 20 | |
Beginning Balance (shares) at Dec. 31, 2019 | 25,912,137 | 105,144 | |||||
Stock-based compensation | 9,821 | 9,821 | |||||
Repurchased and retired common stock | (424,429) | ||||||
Exercise of stock options | 453 | 453 | |||||
Exercise of stock options (shares) | 58,549 | ||||||
Repayment of subscription receivable | 410 | $ 410 | |||||
Net loss | (42,694) | (42,694) | |||||
Unrealized gain (loss) on marketable securities | (19) | (19) | |||||
Ending Balance at Dec. 31, 2020 | 32,986 | $ 3 | 136,868 | (103,886) | 1 | ||
Ending Balance (shares) at Dec. 31, 2020 | 25,546,257 | 105,144 | |||||
Stock-based compensation | 6,053 | 6,053 | |||||
Issuance of common stock, net of issuance costs (shares) | 2,033,899 | ||||||
Issuance of common stock, net of issuance costs | 28,118 | 28,118 | |||||
Exercise of stock options | 558 | 558 | |||||
Exercise of stock options (shares) | 44,041 | ||||||
Net loss | (35,080) | (35,080) | |||||
Unrealized gain (loss) on marketable securities | (30) | (30) | |||||
Ending Balance at Dec. 31, 2021 | $ 32,605 | $ 3 | $ 171,597 | $ (138,966) | $ (29) | ||
Ending Balance (shares) at Dec. 31, 2021 | 27,624,197 | 105,144 |
STATEMENTS OF CASH FLOWS
STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Cash flows from operating activities | ||
Net loss | $ (35,080,000) | $ (42,694,000) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 6,053,000 | 9,821,000 |
Amortization of premiums / (discounts) on marketable securities | 66,000 | (138,000) |
Depreciation expense | 244,000 | 43,000 |
Noncash interest expense | 1,442,000 | 940,000 |
Amortization on operating lease right-of-use asset | 228,000 | 186,000 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | (543,000) | 786,000 |
Accounts payable | 497,000 | (838,000) |
Accrued expenses and other current liabilities | 208,000 | 1,394,000 |
Deferred revenue | (500,000) | 500,000 |
Operating lease liability | (197,000) | (207,000) |
Net cash used in operating activities | (27,582,000) | (30,207,000) |
Cash flows from investing activities | ||
Purchases of marketable securities | (68,914,000) | (71,738,000) |
Sales and maturities of marketable securities | 69,000,000 | 69,849,000 |
Purchases of property and equipment | (883,000) | (1,470,000) |
Deposits | (201,000) | (221,000) |
Net cash used in investing activities | (998,000) | (3,580,000) |
Cash flows from financing activities | ||
Proceeds from exercise of stock options | 558,000 | 453,000 |
Proceeds from issuance of common stock, net of issuance costs | 28,118,000 | |
Proceeds from issuance of debt, net of issuance costs | 4,975,000 | 34,460,000 |
Debt issuance cost | (91,000) | |
Repayment of subscription receivable | 410,000 | |
Repayment of financing lease | (5,000) | |
Net cash provided by financing activities | 33,646,000 | 35,232,000 |
Net increase in cash and cash equivalents | 5,066,000 | 1,445,000 |
Cash and cash equivalents at the beginning of the year | 10,686,000 | 9,241,000 |
Cash and cash equivalents at the end of the year | 15,752,000 | 10,686,000 |
Supplemental disclosure of noncash investing and financing activities: | ||
Property and equipment purchases payable or accrued at period end | 255,000 | 318,000 |
Right-of-use asset obtained in exchange for lease obligation | 1,910,000 | |
Change in unrealized loss on marketable securities | (30,000) | (19,000) |
Cash paid for interest | $ 2,850,000 | 1,875,000 |
Debt issuance costs included in accrued expenses at year end | $ 100,000 |
Organization and Description of
Organization and Description of Business Operations | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Description of Business Operations | Note 1—Organization and Description of Business Operations Verrica Pharmaceuticals Inc. (the “Company”) was formed on July 3, 2013 and is incorporated in the State of Delaware. The Company is a dermatology therapeutics company committed to the development and commercialization of novel treatments that provide meaningful benefit for people living with skin diseases. Liquidity and Capital Resources The Company has incurred substantial operating losses since inception and expects to continue to incur significant operating losses for the foreseeable future and may never become profitable. As of December 31, 2021, the Company had an accumulated deficit of $ 139.0 million. On March 17, 2021, the Company entered into the Torii Agreement (Note 13), pursuant to which the Company received an upfront payment from Torii of $ 11.5 million in April 2021. On March 25, 2021, the Company closed a follow-on public offering in which it sold 2,033,899 shares of common stock at a public offering price of $ 14.75 per share, resulting in net proceeds of $ 28.1 million after deducting underwriting discounts and commissions and offering expenses. In March 2020, the Company entered into a Mezzanine Loan Agreement (as defined in Note 11), pursuant to which the Company borrowed (i) $ 35.0 million in March 2020 (the “Term A Loan”) and (ii) $ 5.0 million on March 1, 2021 (the “Term B 1 Loan” and together with the Term A Loan, the “Term Loans”) that remains outstanding as of December 31, 2021. On March 1, 2022, the Company entered into a second amendment to the Mezzanine Loan Agreement (the “Second Mezzanine Loan Amendment”). Pursuant to the Second Mezzanine Loan Amendment the Company is no longer required to maintain a minimum liquidity ratio or achieve minimum levels of trailing six-month net product revenues but will be required to maintain a minimum balance equal to the outstanding amount of the Term Loans under the Existing Mezzanine Credit Facility (as defined in Note 14) in a separate money market account with Silicon Valley Bank (“SVB”). Additionally, the Company entered into a second amendment (the “Second Senior Loan Amendment”) to the Senior Loan Agreement (as defined in Note 11). Pursuant to the Second Senior Loan Amendment, the Company is no longer required to achieve minimum levels of trailing six-month net product revenues. The Company believes its cash, cash equivalents and marketable secu rities of $ 70.4 million as of December 31, 2021 will be sufficient to support the Company’s planned operations into the third quarter of 2022. Substantial additional financing will be needed by the Company to fund its operations. The Company's financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty. The Company anticipates incurring additional losses until such time, if ever, that it can obtain marketing approval to sell, and then generate significant sales of VP-102. These factors raise substantial doubt about the Company's ability to continue as a going concern within one year after the date the financial statements are issued. The Company plans to secure additional capital in the future through equity or debt financings, partnerships, or other sources to carry out the Company’s planned development activities. If the Company is unable to raise capital when needed or on attractive terms, the Company would be forced to delay, reduce or eliminate its research and development programs or future commercialization efforts. |
Significant Accounting Policies
Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | Note 2—Significant Accounting Policies Basis of Presentation The accompanying financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). The Company’s functional currency is the U.S. dollar. The Company has been actively monitoring the novel coronavirus (“COVID-19”) pandemic and its impact globally. Management believes the financial results for the years ended December 31, 2021 and 2020, were not significantly impacted by COVID-19. In addition, management believes the remote working arrangements, travel restrictions and any other regulations imposed by various governmental jurisdictions have had limited impact on the Company’s ability to maintain internal operations during the year. The full extent to which the COVID-19 pandemic will directly or indirectly impact the Company’s business, results of operations and financial condition will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain it or treat COVID-19. As a direct result of COVID-19, the Company decided to delay the initiation of its previously planned Phase 2 clinical trial to evaluate VP-103 in subjects with plantar warts. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. These estimates and assumptions are based on current facts, historical experience as well as other pertinent industry and regulatory authority information, including the potential future effects of COVID-19, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected. Segments Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating segment. Cash, Cash Equivalents and Marketable Securities The Company considers all highly liquid investments purchased with original maturities of 90 days or less at acquisition to be cash equivalents. Cash and cash equivalents include cash held in banks and money market mutual funds. The Company classifies its marketable securities as “available-for-sale”, pursuant to ASC 320 , Investments—Debt and Equity Securities , carries them at fair market value and classifies them as current assets on its balance sheets. There were no marketable securities with a maturity of greater than one year as of December 31, 2021 . Unrealized gains and losses on marketable debt securities are recorded as a separate component of accumulated other comprehensive gain or loss included in stockholders’ equity. Concentrations of Credit Risk and Off-Balance Sheet Risk Cash, cash equivalents and marketable securities are financial instruments that are potentially subject to concentrations of credit risk. The Company’s deposits are in accounts at large financial institutions, and amounts may exceed federally insured limits. The Company believes it is not exposed to significant credit risk due to the financial strength of the depository institutions in which the funds are held. The Company has no financial instruments with off-balance sheet risk of loss. Property and Equipment Property and equipment is recorded at cost less accumulated depreciation. Depreciation and amortization is calculated using the straight line method over the expected useful life of the asset, after the asset is placed in service. The Company generally uses the following depreciable lives for its major classifications of property and equipment: Expenditures associated with upgrades and enhancements that improve, add functionality, or otherwise extend the life of property and equipment are capitalized, while expenditures that do not, such as repairs and maintenance, are expensed as incurred. The Company reviews long-lived assets, including property and equipment, for impairment whenever events or changes in business circumstances indicate that the carrying amount of an asset may not be fully recoverable. If the estimated undiscounted future cash flows expected to result from the use of the asset and its eventual disposition is less than its carrying amount, an impairment loss would be recognized if the carrying value of the asset exceeds its fair value. Fair value is generally determined using discounted cash flows. No impairment losses have been recorded during the years ended December 31, 2021 or 2020. Description Useful lives Machinery and equipment 3 - 5 years Office furniture and fixtures and equipment 3 years Leasehold improvements Lease Term Automobiles 3 years Revenue In accordance with FASB’s ASC 606, Revenue from Contracts with Customers (“ASC 606”), the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, it performs the following five steps: (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 in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company 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 each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. License Revenues The Company’s revenues have been solely generated through licensing arrangements. The terms of the agreement typically include payments to the Company of one or more of the following: nonrefundable, up-front license fees: regulatory and commercial milestone payments; payments for manufacturing supply services; materials shipped to support development; and royalties on net sales of licensed products. In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under each of its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. The Company also assesses whether there is an option in a contract to acquire additional goods or services. An option gives rise to a performance obligation only if the option provides a material right to the customer that it would not receive without entering into that contract. Factors that the Company considers in evaluating whether an option represents a material right include, but are not limited to: (i) the overall objective of the arrangement, (ii) the benefit the collaborator might obtain from the arrangement without exercising the option, (iii) the cost to exercise the option (e.g. priced at a significant and incremental discount) and (iv) the likelihood that the option will be exercised. With respect to options determined to be performance obligations, the Company recognizes revenue when those future goods or services are transferred or when the options expire. The Company’s 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 regulatory or commercial milestone payments, the Company evaluates whether each milestone is considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. At each reporting period, the Company assesses the probability of achievement of each milestone under its current agreements. Royalties: If the Company is entitled to receive sales-based royalties from its collaborator, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, provided the reported sales are reliably measurable, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Manufacturing Supply and Research Services : Arrangements that include a promise for future supply of drug substance or drug product for either clinical development or commercial supply at the licensee’s discretion are generally considered as options. The Company assesses if these options provide a material right to the licensee and if so, they are accounted for as separate performance obligations. The Company receives payments from its licensees based on schedules established in each contract. Upfront payments are recorded as deferred revenue upon receipt, and may require deferral of revenue recognition to a future period until the Company performs its obligations under these arrangements. Amounts are recorded as accounts receivable when the Company’s right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the licensees and the transfer of the promised goods or services to the licensees will be one year or less. See Note 13 for a full discussion of the Company’s license revenue. Research and Development Costs The Company’s research and development expenses consist primarily of costs associated with the Company’s clinical trials, salaries, payroll taxes, employee benefits, and equity-based compensation charges for those individuals involved in ongoing research and development efforts. Research and development costs are expensed as incurred. Advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made. Fair Value Measurement ASC 820, Fair Value Measurements , provides guidance on the development and disclosure of fair value measurements. Under this accounting guidance, fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability. The accounting guidance classifies fair value measurements in one of the following three categories for disclosure purposes: Level 1: Quoted prices in active markets for identical assets or liabilities. Level 2: Inputs other than Level 1 prices for similar assets or liabilities that are directly or indirectly observable in the marketplace. Level 3: Unobservable inputs which are supported by little or no market activity and values determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation. Comprehensive Loss Comprehensive 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. For the years ended December 31, 2021 and 2020 , comprehensive loss includes net loss and unrealized loss on marketable securities. Stock-Based Compensation The Company accounts for stock-based compensation awards in accordance with ASC 718, Compensation –Stock Compensation . The Company uses the Black-Scholes option-pricing model to value its stock option awards. For stock-based awards granted to employees, non-employees and to members of the board of directors for their services, the Company estimates the grant date fair value of each option award and recognizes compensation expense on a straight-line basis over the vesting period of the award. The use of the Black‑Scholes option-pricing model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the common stock consistent with the expected life of the option, risk‑free interest rates, and, for grants prior to the Company’s IPO, the value of the common stock. The expected life of stock options was estimated using the “simplified method,” as the Company has limited historical information to develop reasonable expectations about future exercise patterns and post-vesting employment termination behavior for its stock options grants. The simplified method is based on the average of the vesting tranches and the contractual life of each grant. The Company historically has been a private company and lacks company-specific historical and implied volatility information. Therefore, it estimates its expected stock volatility based on the historical volatility of a publicly traded set of peer companies in addition to the volatility of the Company's stock. The risk-free interest rate is based on U.S. Treasury notes with a term approximating the expected life of the option. Expected dividend yield is zero based on the fact that the Company has never paid cash dividends and does no t expect to pay any cash dividends in the foreseeable future. The fair value of restricted stock awards are based on the closing price of the Company’s common stock on the grant date. Income Taxes Income taxes are recorded in accordance with ASC 740, Income Taxes , which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Valuation allowances are provided, if based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit would more likely than not be realized assuming examination by the taxing authority. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. Net Loss Per Share Net 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 for the period. Diluted net loss per share excludes the potential impact of common stock options and unvested shares of restricted stock because their effect would be anti-dilutive due to the Company’s net loss. Since the Company had a net loss in each of the periods presented, basic and diluted net loss per common share are the same. The table below provides potential shares outstanding that were not included in the computation of diluted net loss per common share, as the inclusion of these securities would have been anti-dilutive: As of December 31, 2021 2020 Shares issuable upon exercise of stock options 3,443,817 2,901,908 Non-vested shares under restricted stock grants 425,000 475,000 Recently Adopted Accounting Pronouncements In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework–Changes to the Disclosure Requirements for Fair Value Measurement , which makes a number of changes meant to add, modify or remove certain disclosure requirements associated with the movement amongst or hierarchy associated with Level 1, Level 2 and Level 3 fair value measurements. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. The adoption of this guidance as of January 1, 2020 did no t have an impact on the financial statements. In August 2018, the FASB issued ASU 2018-15, Intangibles–Goodwill and Other–Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement that is a Service Contract , which aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software (and hosting arrangements that include an internal-use software license). The guidance also requires the entity to expense the capitalized implementation costs of a hosting arrangement that is a service contract over the term of the hosting arrangement, which includes reasonably certain renewals. The adoption of this guidance as of January 1, 2020 did no t have an impact on the financial statements. As of January 1, 2020 the Company has adopted Accounting Standards Codification Topic 606, “Revenue from Contracts with Customers.” In accordance with FASB’s ASC 606, Revenue from Contracts with Customers (“ASC 606”), the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. The adoption of this guidance as of January 1, 2020 did not have an impact on the prior year financial statements. |
Investments In Marketable Secur
Investments In Marketable Securities | 12 Months Ended |
Dec. 31, 2021 | |
Investments [Abstract] | |
Investments in Marketable Securities | Note 3—Investments in Marketable Securities Investments in marketable securities consisted of the following as of December 31, 2021 and 2020 (in thousands): As of December 31, 2021 Amortized Gross Gross Fair Cost Gains Losses Value U.S. treasury securities $ 15,272 — $ ( 15 ) $ 15,257 Commercial paper 28,980 — — 28,980 Asset-backed securities 10,379 — ( 14 ) 10,365 Total marketable securities $ 54,631 $ — $ ( 29 ) $ 54,602 As of December 31, 2020 Amortized Gross Gross Fair Cost Gains Losses Value U.S. treasury securities $ 11,607 $ 2 $ — $ 11,609 Commercial paper 41,674 — ( 1 ) 41,673 Asset-backed securities 1,502 — — 1,502 Total marketable securities $ 54,783 $ 2 $ ( 1 ) $ 54,784 Unrealized gains and losses on marketable debt securities are recorded as a separate component of accumulated other comprehensive gain (loss) included in stockholders’ equity. Realized gains (losses) are included in interest income (expense) in the statement of operations and comprehensive loss on a specific identification basis. The Company recorded nominal realized gains and losses during the years ended December 31, 2021 and 2020. The Company has not recorded any impairment charges on marketable securities related to other-than-temporary declines in market value during the years ended December 31, 2021 or 2020. Accretion of bond discount and premium on marketable securities and interest income on marketable securities is recorded as interest income on the statement of operations and comprehensive loss. There were no marketable securities with a maturity of greater than one year for either period presented. Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Financial assets and liabilities carried at fair value are classified and disclosed in one of the following three categories: Level 1 — Quoted market prices in active markets for identical assets or liabilities. Level 2 — Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The following tables presents fair value by level in accordance with ASC 820 (see Note 2) of the Company’s marketable securities (in thousands): Fair Value Measurement as of December 31, 2021 Level 1 Level 2 Level 3 Total U.S. treasury securities $ 15,257 $ — $ — $ 15,257 Commercial paper — 28,980 — 28,980 Asset-backed securities — 10,365 — 10,365 Total $ 15,257 $ 39,345 $ — $ 54,602 Fair Value Measurement as of December 31, 2020 Level 1 Level 2 Level 3 Total U.S. treasury securities $ 11,609 $ — $ — $ 11,609 Commercial paper — 41,673 — 41,673 Asset-backed securities — 1,502 — 1,502 Total $ 11,609 $ 43,175 $ — $ 54,784 |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | N ote 4—Property and Equipment Property and equipment, net consisted of (in thousands): As of December 31, 2021 2020 Machinery and equipment $ 737 $ 102 Office furniture and fixtures 303 117 Office equipment 301 52 Leasehold improvements 49 101 Automobiles 27 — Construction in process 2,731 2,857 4,148 3,229 Accumulated depreciation ( 254 ) ( 127 ) Total property and equipment, net $ 3,894 $ 3,102 Depreciation expense for the years ended December 31, 2021 and 2020 was $ 244,000 and $ 43,000 , respectively. The Company has recorded an asset classified as construction in process associated with the construction of a product assembly and packaging line that would be placed into service for commercial manufacturing upon future regulatory product approval. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2021 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Note 5—Related Party Transactions Prior to the completion of the initial public offering (“IPO”) of the Company’s common stock in June 2018, the Company was controlled by PBM VP Holdings, LLC (“PBM VP Holdings”) an affiliate of PBM Capital Group, LLC (“PBM”). Paul B. Manning, who is the Chairman and Chief Executive Officer of PBM and the current chairman of the Company’s Board of Directors, and certain entities affiliated with Mr. Manning, continue to be the Company’s largest shareholder on a collective basis. On December 2, 2015, the Company entered into a Services Agreement (the “SA”) with PBM. Pursuant to the terms of the SA, which had an initial term of twelve months (and was automatically renewable for successive monthly periods), PBM rendered advisory and consulting services to the Company. Services provided under the SA included certain business development, operations, technical, contract, accounting and back office support services. In consideration for these services, the Company was obligated to pay PBM a monthly management fee. On October 1, 2019, the SA was amended to reduce the monthly management fee to $ 5,000 as a result of a reduction in services provided by PBM. For each of the years ended December 31, 2021 and 2020, the Company incurred expenses under the SA o f $ 60,000 , of which $ 36,000 were included in general and administrative expenses, and $ 24,000 were included in research and development expenses. As of December 31, 2021 and 2020 , the Company had no payables due to PBM and its affiliates. |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2021 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | Note 6—Accrued Expenses Accrued expenses consisted of the following (in thousands): As of December 31, 2021 2020 Compensation and related costs $ 1,667 $ 1,338 Clinical trials and drug development 613 611 Professional fees 406 447 Interest expense 250 219 Construction in process 131 277 Machinery and equipment 124 — Other accrued expenses and other current liabilities 75 222 Total accrued expenses and other current liabilities $ 3,266 $ 3,114 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 7—Commitments and Contingencies Litigation The Company is involved in ordinary, routine legal proceedings that are not considered by management to be material. In the opinion of Company counsel and management, the ultimate liabilities resulting from such legal proceedings will not materially affect the financial position of the Company or its results of operations or cash flows. Supply Agreement and Purchase Order On July 16, 2018, the Company entered into a supply agreement with a supplier of crude cantharidin material. All executed purchase orders for crude cantharidin in the ordinary course of business are expected to be covered under the terms of the supply agreement. Pursuant to the supply agreement, the supplier has agreed that it will not supply cantharidin, any beetles or other raw material from which cantharidin is derived to any other customer in North America, subject to specified minimum annual purchase orders and forecasts by the Company. The supply agreement has an initial five-year term, which is subject to automatic renewal absent termination by either party in accordance with the terms of the supply agreement. Each party also has the right to terminate the supply agreement for other customary reasons such as material breach or bankruptcy. During 2019, the Company executed a single purchase order pursuant to which the Company agreed to purchase $ 1.8 million of crude cantharidin material and made a prepayment of $ 1.1 million against this purchase order. The Company received the shipments of material in 2020 and as of December 31, 2020, this purchase order was fulfilled. During 2021, the Company executed a single purchase order pursuant to which the Company agreed to purchase $ 0.8 million of crude cantharidin material and made a prepayment of $ 0.8 million against this purchase order, recorded as prepaid expense in the balance sheet as of December 31, 2021. The Company received the shipments of material in 2022. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Stockholders' Equity | Note 8—Stockholders’ Equity Common Stock The Company had authorized 200,000,000 shares of common stock, $ 0.0001 par value per share, as of each of December 31, 2021 and 2020 . Each share of common stock is entitled to one vote. Common stock owners are entitled to dividends when funds are legally available and declared by the Board. On March 25, 2021, the Company closed a follow-on public offering in which it sold 2,033,899 shares of common stock at a public offering price of $ 14.75 per share, resulting in net proceeds of $ 28.1 million after deducting underwriting discounts and commissions and offering expenses. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Note 9—Stock-Based Compensation In June 2018, the Board adopted and approved the 2018 Equity Incentive Plan (the “2018 Plan”), which amended and restated the Company’s prior 2013 Equity Incentive Plan (the “2013 Plan”) and became effective in connection with the IPO. Prior to the effectiveness of the 2018 Plan, the 2013 Plan provided for the grant of share-based awards to employees, directors and consultants of the Company. As a result of the effectiveness of the 2018 Plan, no further grants may be made under the 2013 Plan. The 2018 Plan provides for the grant of incentive stock options to employees, and for the grant of nonstatutory stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, performance-based stock awards and other forms of stock awards to employees, including officers, consultants and directors. The 2018 Plan also provides for the grant of performance-based cash awards to employees, including officers, consultants and directors. The Company initially reserved 3,738,199 shares of common stock for issuance under the 2018 Plan, which is the sum of (1) 2,198,198 new shares, plus (2) the number of shares reserved for issuance under the 2013 Plan at the time the 2018 Plan became effective, plus (3) any shares subject to outstanding stock options or other stock awards that would have otherwise returned to the 2013 Plan (such as upon the expiration or termination of a stock award prior to exercise). The number of shares of common stock reserved for issuance under the 2018 Plan will automatically increase on January 1 each year, for a period of ten years , from January 1, 2019 through January 1, 2028, by 4 % of the total number of shares of the Company’s common stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares as may be determined by the Board. As of December 31, 2021 , 2,496,593 shares were available for grant under the 2018 Plan. Stock Options The Company’s employee and non-employee stock options generally vest as follows: 25 % after 12 months of continuous services and the remaining 75 % on a ratable basis over a 36-month period from 12 months after the grant date. Stock options granted during the year ended December 31, 2021 have a maximum contractual term of 10 years . The stock options are subject to time vesting requirements through 2025 , are nontransferable, and have term expiration dates set to expire through 2031 . The grant date fair value of employee and non-employee stock option awards is determined using the Black-Scholes option-pricing model. The following assumptions were used during the years ended December 31, 2021 and 2020 to estimate the fair value of employee and non-employee stock option awards: For the Year Ended December 31, 2021 2020 Exercise price $ 9.26 - $ 15.10 $ 6.56 - $ 15.91 Risk-free rate of interest 0.76 % - 1.24 % 0.27 % - 1.67 % Expected term (years) 6 6 Expected stock price volatility 87.14 % - 89.39 % 76.71 % - 85.97 % Dividend yield — — Weighted average grant date fair value $ 9.72 $ 7.00 The following table summarizes the Company’s employee and non-employee stock option activity under the 2013 Plan and 2018 Plan for the years ended December 31, 2021 and 2020: Weighted average Number of Weighted average remaining contractual Aggregate intrinsic shares exercise price life (in years) value Outstanding as of December 31, 2019 1,914,545 $ 9.14 Options granted 1,193,956 10.35 Exercised ( 58,549 ) 7.73 Forfeited ( 125,377 ) 10.78 Expired ( 22,667 ) 12.00 Outstanding as of December 31, 2020 2,901,908 9.57 Options granted 1,222,786 13.28 Exercised ( 44,041 ) 12.67 Forfeited ( 462,617 ) 13.87 Expired ( 174,219 ) 13.84 Outstanding as of December 31, 2021 3,443,817 $ 10.05 7.8 $ 3,952,803 Options vested and exercisable 1,757,554 $ 8.48 6.7 $ 3,211,470 The aggregate intrinsic value in the above table is calculated as the difference between fair value of the Company’s common stock price and the exercise price of the stock options. The weighted average grant date fair value per share for the employee and non-employee stock options granted during the years ended December 31, 2021 and 2020 w as $ 9.72 and $ 7.00 , respectively. As of December 31, 2021, the total unrecognized compensation related to unvested employee and non-employee stock option awards granted was $ 11.7 million, which the Company expects to recognize over a weighted-average period of 2.9 years. The Company utilizes a designated broker to process exercises of stock options. In late December 2019, there was an exercise of 27,329 vested stock options for which the Company did not receive the net proceeds from the designated broker until early January 2020. The net proceeds were reflected as a stock subscription receivable as of December 31, 2019 in the balance sheet. Restricted Stock Pursuant to the Amended and Restated Stock Purchase Agreement (the “Amended and Restated Agreement”) between the Company and the former CSO, 848,859 shares held by the former CSO were subject to repurchase by the Company at $ 0.0001714 per share in the event the former CSO ceased to be a consultant to the Company. These shares were to be released from the repurchase option on the earliest to occur of (i) a change in control, (ii) regulatory approval of the Company’s new drug application for VP-102 for the treatment of molluscum, (iii) commercial sale of products and (iv) a covered termination, as defined in the Amended and Restated Agreement. In December 2020, the Company and the former CSO amended the agreement whereby 424,430 shares were no longer subject to repurchase and the remaining 424,429 shares were repurchased and retired by the Company at $ 0.0001714 per share. The Company accounted for the December 2020 amendment as a modification to a share-based payment arrangement whereby the shares no longer subject to repurchase represent a new grant. The value of the new grant was $ 4.8 million and was recognized immediately. Prior to the December 2020 modification, no compensation expense had been recognized for these nonvested shares as these shares were performance-based and the triggering event was not determined to be probable. In November 2019 and August 2020, the Company granted 300,000 and 250,000 restricted stock units to its executive officers. The restricted stock units vest 50 % upon receipt of regulatory approval of the Company’s new drug application for VP-102 for the treatment of molluscum (the “Approval Date”) and 50 % shall vest on the one year anniversary of the Approval Date subject to the holders’ continuous service through each applicable date. No compensation expenses has been recognized for these nonvested restricted stock units as these shares are performance based and the triggering event was not determined to be probable as of December 31, 2021. As of December 31, 2021 the total unrecognized compensation expense related to the restricted stock was $ 5.0 million. The following table summarizes restricted stock awards: Weighted Average Grant Date Fair Number of Shares Value Non-vested as of December 31, 2019 1,148,859 $ 4.35 Granted 250,000 8.17 Forfeitures ( 499,429 ) 2.64 Vested ( 424,430 ) $ 11.27 Non-vested as of December 31, 2020 475,000 11.74 Granted — — Forfeitures ( 50,000 ) 12.29 Vested — — Non-vested as of December 31, 2021 425,000 $ 11.68 Stock-based compensation expense, which includes expense for both employees and non-employees, has been reported in the Company’s statements of operations for the years ended December 31, 2021 and 2020 as follows (in thousands): For the Year Ended December 31, 2021 2020 Research and development $ 1,513 $ 813 General and administrative 4,540 9,008 Total stock-based compensation $ 6,053 $ 9,821 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Leases | Note 10—Leases Effective January 1, 2019, the Company accounts for its leases under ASC 842, Leases (Topic 842). Under this guidance, arrangements meeting the definition of a lease are classified as operating or financing leases and are recorded on the balance sheet as both a right-of-use asset and lease liability, calculated by discounting fixed lease payments over the lease term at the rate implicit in the lease, if available, otherwise at the Company’s incremental borrowing rate. Lease liabilities are increased by interest and reduced by payments each period, and the right-of-use asset is amortized over the lease term. For operating leases, interest on the lease liability and the amortization of the right-of-use asset result in straight-line rent expense over the lease term. Variable lease expenses, if any, are recorded when incurred. In calculating the right-of-use asset and lease liability, the Company elected to combine lease and non-lease components. The Company excludes short-term leases having initial terms of 12 months or less from the guidance as an accounting policy election and recognizes rent expense on a straight-line basis over the lease term. The Company leased office space in West Chester, Pennsylvania under an agreement classified as an operating lease that expired in May 2021 . On July 1, 2019 , the Company entered into a lease for 5,829 square feet of office space located in West Chester, Pennsylvania that serves as the Company’s headquarters. On March 12, 2020 the Company entered into an amendment to the lease agreement. The amendment expands the original premises to include 5,372 square feet of additional office space increasing the total rentable premise to 11,201 square feet of space. For the first six months following the commencement date of September 1, 2020, the base rent was based on the square footage of the original premises. The initial term will expire on September 1, 2027 . Base rent over the initial term is approximately $ 2.4 million, and the Company is also responsible for its share of the landlord’s operating expense. At the commencement date of the new lease, the Company recorded a right-of-use asset of $ 1.9 million and a lease liability of $ 1.9 million on the balance sheet. As of December 31, 2021 , the Company had an operating lease liability of $ 1,694,000 , of which $ 244,600 was classified as current, and an operating right-of-use asset of $ 1,608,000 . The Company leases a vehicle for the sales force under a financing lease that expires through 2025 . The net basis of the vehicle leas e of $ 22,000 is recorded as property and equipment on the condensed balance sheet. The components of lease expense are as follows (in thousands): For the Year Ended 2021 2020 Finance lease cost: Amortization ROU assets $ 5 $ — Finance lease costs — — Interest on lease liabilities — — Total finance lease cost $ 5 $ — Operating lease Operating lease costs $ 346 $ 164 Short-term lease costs 21 22 Total operating lease $ 367 $ 186 Maturities of the Company’s operating lease, excluding short-term leases as of December 31, 2021 are as follows (in thousands): December 31, 2021 Operating Finance 2022 $ 344 $ 7 2023 349 7 2024 355 8 2025 360 2 Thereafter 613 — Total lease payments 2,021 24 Less imputed interest ( 327 ) ( 2 ) Lease liability $ 1,694 $ 22 The remaining term of the Company’s operating and finance leases were 5.7 and 3.3 years, respectively and the discount rate used to measure the present value of the Company’s operating and finance lease liability were 6.25 % and 4.35 %, respectively as of December 31, 2021. |
Debt
Debt | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Debt | Note 11–Debt On March 10, 2020 (the “Effective Date”), the Company entered into (i) a mezzanine loan and security agreement (the “Mezzanine Loan Agreement”) with Silicon Valley Bank, or SVB, as administrative agent and collateral agent (the “Agent”), and Silicon Valley Bank and West River Innovation Lending Fund VIII, L.P., as lenders (the “Mezzanine Lenders”), pursuant to which the Mezzanine Lenders have agreed to lend the Company up to $ 50.0 million in a series of term loans, and (ii) a loan and security agreement (the “Senior Loan Agreement”, and together with the Mezzanine Loan Agreement, the “Loan Agreements”) with Silicon Valley Bank, as lender (the “Senior Lender”, and together with the Mezzanine Lenders, the “Lenders”), pursuant to which the Senior Lender has agreed to provide the Company with a revolving line of credit of up to $ 5.0 million. Upon entering into the Loan Agreements, the Company borrowed the “Term A Loan”. On October 26, 2020, the Company entered into (i) the first amendment to the Mezzanine Loan Agreement (the “Mezzanine Loan Amendment”) and (ii) the first amendment to the Senior Loan Agreement (the “Senior Loan Amendment” and together with the Mezzanine Loan Amendment the “Loan Agreement Amendments”) with the Lenders, under which the Company borrowed the “Term B1 Loan”. On March 1, 2022, the Company entered into the Second Mezzanine Loan Amendment . Pursuant to the Second Mezzanine Loan Amendment, the Company is no longer required to maintain a minimum liquidity ratio or achieve minimum levels of trailing six-month net product revenues. Under the terms of the Second Mezzanine Loan Amendment, the Company will be required to maintain a minimum cash balance equal to the outstanding amount of the term loans under the Existing Mezzanine Credit Facility (as defined in Note 14) at all times in a separate money market account with SVB. The Company also entered into the Second Senior Loan Amendment pursuant to which, the Company is no longer required to achieve minimum levels of trailing six-month net product revenues. See Note 14 for additional discussion of the Second Mezzanine Loan Amendment and the Second Senior Loan Amendment. Under the terms of the Senior Loan Agreement, as amended, the Company may, at its sole discretion, borrow from the Senior Lender one or more advances on the revolving credit line (the “Revolving Loans”, and together with the Term Loans, the “Loans”) in an aggregate amount not to exceed the lesser of (i) 85 % of the aggregate amount then-contained in the Company’s eligible accounts receivable and (ii) $ 5.0 million. The Company’s obligations under the Senior Loan Agreement and the Mezzanine Loan Agreement, as amended, are secured by, respectively, a first priority perfected security interest and second priority perfected security interest in substantially all of the Company’s current and future assets, other than its intellectual property (except rights to payment from the sale, licensing or disposition of such intellectual property). The Company has also agreed not to encumber its intellectual property assets, except as permitted by the Loan Agreements. All of the Loans mature on March 1, 2024 (the “Maturity Date”). The Term Loans will be interest-only through March 31, 2022, followed by 24 equal monthly payments of principal and interest. The Term Loans will bear interest at a floating per annum rate equal to the greater of (i) 7.25 % and (ii) the sum of (a) the prime rate reported in The Wall Street Journal on the last business day of the month that immediately precedes the month in which the interest will accrue, plus (b) 2.50 %. The Revolving Loans will bear interest at a floating per annum rate equal to the greater of (i) 6.00 % and (ii) the sum of (a) the prime rate reported in The Wall Street Journal on the last business day of the month that immediately precedes the month in which the interest will accrue, plus (b) 1.25 %. Under the terms of the Mezzanine Loan Agreement, as amended, the Company will be required to make a final payment fee of $ 3,750,000 payable on the earlier of (i) the Maturity Date, (ii) the acceleration of any Term Loans, or (iii) the prepayment of the Term Loans (the “Final Payment”). The Company is recording the final payment fee using the effective interest rate method over the term of the Term Loan with an increase in debt. The Company may prepay all, or any portion of the Term Loans upon 5 business days advance written notice to the Agent, provided that the Company will be obligated to pay a prepayment fee equal to (i) $ 1.0 million if prepaid between October 27, 2021 and October 26, 2022, and (ii) $ 0.5 million if prepaid between October 27, 2022 and October 26, 2023 and (iii) no prepayment fee if prepaid after October 26, 2023 (each, a “Prepayment Fee”). The Company may terminate the revolving credit line under the Senior Loan Agreement at any time upon three business days advance written notice to the Senior Lender. If the Company terminates the revolving credit line prior to the Maturity Date, it must pay to the Senior Lender an early termination fee of $ 50,000 (the “Termination Fee”). Under the Loan Agreements, as amended, the Company is subject to a number of affirmative and restrictive covenants, including covenants regarding delivery of financial statements, maintenance of inventory, payment of taxes, maintenance of insurance, protection of intellectual property rights, dispositions of property, business combinations or acquisitions, incurrence of additional indebtedness or liens, investments and transactions with affiliates among other customary covenants. As of December 31, 2021 the Company is in compliance with all covenants. Upon the occurrence of certain events, including but not limited to the Company’s failure to satisfy its payment obligations under the Loan Agreements, the breach of certain of its other covenants under the Loan Agreements, or the occurrence of a material adverse change, cross defaults to other indebtedness or material agreements, judgment defaults and defaults related to failure to maintain governmental approvals failure of which to maintain could result in a material adverse effect, the Agent and the Lenders will have the right, among other remedies, to declare all principal and interest immediately due and payable, to exercise secured party remedies, to receive the Final Payment and Termination Fee and, if the payment of principal and interest is due prior to the Maturity Date, to receive the applicable Prepayment Fee. The Loan Agreements also include subjective acceleration clauses that permit the Lenders to accelerate the maturity date under certain circumstances, including a material adverse change in the Company’s business, operations, or financial condition or a material impairment of the prospect of repayment of the Company’s obligations to the Mezzanine Lenders. The Company believes that, without additional financing, it is probable that it will not be in compliance with its minimum liquidity ratio covenant at some point in the next twelve months. In addition, under the Second Mezzanine Loan Amendment dated March 1, 2022, without additional financing, it is probable that the Company will not be in compliance with its minimum cash requirement covenant at some point in the next twelve months. In accordance with FASB ASC 470, since the Mezzanine Loan Agreement contains subjective acceleration clauses and the assessment that it is probable that the minimum liquidity ratio covenant will not be met, the Company has classified all outstanding principal and final payment fees as a current liability in the accompanying balance sheet as of December 31, 2021. The Company borrowed $ 35.0 million upon entering into the Loan Agreement in March 2020, and an additional $ 5.0 million on March 1, 2021. The Company has incurred debt discount and issuance costs of $ 4.3 million, including the final payment fee of $ 3.8 million, that are classified as a contra-liability on the condensed balance sheet. The Company incurred additional debt issuance costs related to the revolving credit line of $ 0.1 million, classified as other non-current assets in the condensed balance sheet. These costs related to the revolving credit line are being amortized to interest expense over the life of the loans using the straight-line method. For the years ended December 31, 2021 and 2020 , the Company recognized interest expense of $ 4.3 and $ 3.0 million, respectively, of which $ 2.9 and $ 2.1 million, respectively, was interest on the term loan and $ 1.4 and $ 0.9 million, respectively, was noncash interest expense related to the amortization of deferred debt issuance costs and accrual of the final payment fee. The following table summarizes the composition of debt as reflected on the balance sheet as of December 31, 2021 (in thousands): Gross proceeds $ 40,000 Accrued final payment fee 3,750 Unamortized debt discount and issuance costs ( 2,057 ) Total short-term debt, net $ 41,693 The aggregate maturities of debt as of December 31, 2021 are as follows (in thousands): 2022 $ 15,000 2023 20,000 2024 (1) 5,000 Total $ 40,000 (1) Excludes the final payment fee due at time of maturity. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 12–Income Taxe s There is no provision for income taxes as the Company has incurred operating losses since inception and maintains a full valuation allowance against its deferred tax assets. Differences between the provision (benefit) for income taxes and income taxes at the statutory federal income tax rate are as follows (in thousands): For the Year Ended 2021 2020 Tax computed at statutory federal income tax rate $ ( 7,367 ) $ ( 8,966 ) State taxes, net of federal benefit ( 2,697 ) ( 2,938 ) Permanent items 282 1,283 R&D credits 26 ( 2,405 ) Other 205 ( 2 ) Change in valuation allowance 9,551 13,028 Income tax provision (benefit) $ — $ — Significant components of the Company’s deferred tax assets and liabilities are as follows (in thousands): As of 2021 2020 Deferred tax assets: Net operating loss carryovers $ 31,514 $ 23,881 Share-based compensation 3,321 2,170 Tax credits 2,380 2,405 Amortization 678 — Accrued compensation 479 388 Lease liabilities 497 549 Other 16 12 Total deferred tax assets 38,885 29,405 Less valuation allowance ( 38,414 ) ( 28,863 ) Deferred tax asset, net of valuation allowance 471 542 Deferred tax liabilities: Right-of-use assets ( 466 ) ( 532 ) Fixed assets ( 5 ) ( 10 ) Total deferred tax liabilities ( 471 ) ( 542 ) Net deferred tax assets $ — $ — The Company has determined, based upon all available evidence, that it is more likely than not that the net deferred tax asset will not be realized and, accordingly, has provided a full valuation allowance against its net deferred tax asset. As of December 31, 2021, the Company had federal and state net operating loss carryforwards of approximately $ 109.0 million and $ 110.9 million, respectively. The federal net operating loss carryforwards included in the foregoing totals that were generated prior to 2018 (federal of approximately $ 6.9 million) will begin to expire, if not utilized, by 2033 . Under the 2017 federal income tax law changes, federal net operating losses incurred in 2018 and in future years may be carried forward indefinitely, but the deductibility of such federal net operating losses is limited. As of December 31, 2021, the Company had federal and state research and development carryforwards of $ 2.4 million. In ad dition, under Section 382 of the Internal Revenue Code of 1986, as amended, and corresponding provisions of state law, if a corporation undergoes an “ownership change,” which is generally defined as a greater than 50 % change, by value, in its equity ownership over a three-year period, the corporation’s ability to use its pre-change net operating loss and tax credit carryforwards may be limited. The Company has not done an analysis to determine whether or not ownership changes have occurred since inception. As of December 31, 2019, the Company had uncertain tax positions related to federal income tax credits for its research and development activities. The total amount of unrecognized tax benefits was $ 1.5 million. The Company released the uncertain tax position in 2020 and as of December 31, 2021 and 2020 has recognized a deferred tax benefit of $ 2.4 million of federal income tax credits for its research and development activities. The Company will recognize interest and penalties, if any, related to uncertain tax positions in income tax expense. As of December 31, 2021 and 2020, the Company had no accrued interest or penalties related to uncertain tax positions and no amounts have been recognized in the Company’s statement of operations. The Company does not anticipate a material change to unrecognized tax benefits in the next twelve months. The 2017 and subsequent federal and state tax years for the Company remain open for the assessment of income taxes. |
License And Collaboration Agree
License And Collaboration Agreements | 12 Months Ended |
Dec. 31, 2021 | |
License And Collaboration Agreements [Abstract] | |
License and Collaboration Agreements | Note 13—License and Collaboration Agreements In August 2020, the Company entered into an option agreement with Torii Pharmaceutical Co., Ltd. (“Torii”) for the development and commercialization of the Company’s product candidates for the treatment of molluscum contagiosum and common warts in Japan, including VP-102 (the “Option Agreement”). Torii paid the Company $ 0.5 million to secure the exclusive option. The $ 0.5 million is included in deferred revenue as of December 31, 2020 in the balance sheet. On March 2, 2021, Torii exercised the exclusive option in the Option Agreement. On March 17, 2021, the Company entered into a collaboration and license agreement (the “Torii Agreement”) with Torii, pursuant to which the Company granted Torii an exclusive license to develop and commercialize the Company’s product candidates that contain a topical formulation of cantharidin for the treatment of molluscum contagiosum and common warts in Japan, including VP-102. Additionally, the Company granted Torii a right of first negotiation with respect to additional indications for the licensed products and certain additional products for use in the licensed field, in each case in Japan. Pursuant to the Torii Agreement, the Company received payments from Torii of $ 0.5 million in December 2020 and $ 11.5 million in April 2021. Additionally, the Company is entitled to receive from Torii an additional $ 58 million in aggregate payments contingent on achievement of specified development, regulatory, and sales milestones, in addition to tiered transfer price payments for supply of product in the percentage range of the mid- 30 ’s to the mid- 40 ’s of net sales. The transfer payments shall be payable, on a product-by-product basis, beginning on the first commercial sale of such product and ending on the latest of (a) expiration of the last-to-expire valid claim contained in certain licensed patents in Japan that cover such product, (b) expiration of regulatory exclusivity for the first indication for such product in Japan, and, (c) (i) with respect to the first product, ten years after first commercial sale of such product, and, (ii) with respect to any other product, the later of (x) ten years after first commercial sale of the first product and (y) five years after first commercial sale of such product. The Torii Agreement expires on a product-by-product basis upon expiration of Torii’s obligation under the agreement to make transfer price payments for such product. Torii has the right to terminate the agreement upon specified prior written notice to us. Additionally, either party may terminate the agreement in the event of an uncured material breach of the agreement by, or insolvency of, the other party. The Company may terminate the agreement in the event that Torii commences a legal action challenging the validity, enforceability or scope of any licensed patents. In August 2020, the Company entered into an exclusive license agreement with Lytix Biopharma AS (“Lytix”) for the use of licensed technology to research, develop, manufacture, have manufactured, use, sell, have sold, offer for sale, import, and otherwise commercialize products for use in all malignant and pre-malignant dermatological indications, other than metastatic melanoma and metastatic Merkel cell carcinoma (the” Lytix Agreement”). As part of the Lytix Agreement, the Company paid Lytix a one-time up-front fee of $ 0.3 million in 2020. In addition, in February 2021, the Company paid Lytix a one-time $ 2.3 million payment upon the achievement by Lytix of a regulatory milestone. The $ 2.3 and $ 0.3 million payments were recognized in research and development expense in the statement of operations for the years ended December 31, 2021 and 2020, respectively. The Company is also obligated to pay up to $ 111.0 million contingent on achievement of specified development, regulatory, and sales milestones, as well as tiered royalties based on worldwide annual net sales ranging in the low double digits to the mid-teens, subject to certain customary reductions. The Company’s obligation to pay royalties expires on a country-by-country and product-by-product basis on the later of the expiration or abandonment of the last to expire licensed patent covering LTX-315 anywhere in the world and expiration of regulatory exclusivity for LTX-315 in such country. Additionally, all upfront fees and milestone based payments received by the Company from a sublicensee will be treated as net sales and will be subject to the royalty payment obligations under the Lytix Agreement, and all royalties received by the Company from a sublicensee shall be shared with Lytix at a rate that is initially 50 % but decreases based on the stage of development of LTX-315 at the time such sublicense is granted. |
Subsequent Event
Subsequent Event | 12 Months Ended |
Dec. 31, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Event | Note 14–Subsequent Event On March 1, 2022, the Company entered into the Second Mezzanine Loan Amendment to its existing mezzanine loan and security agreement (as amended prior to the Amendment, the “Existing Mezzanine Credit Facility”) with SVB, as administrative agent and a lender and SVB Innovation Credit Fund VIII, L.P. as a lender. Pursuant to the Second Mezzanine Loan Amendment, the Company is no longer required to maintain a minimum liquidity ratio or achieve minimum levels of trailing six-month net product revenues. Under the terms of the Second Mezzanine Loan Amendment, the Company will be required to maintain a minimum cash balance equal to the outstanding amount of the term loans under the Existing Mezzanine Credit Facility at all times in a separate money market account with SVB. The Company also entered into the Second Senior Loan Amendment (together with the Second Mezzanine Loan Amendment, the “Second Amendments”) to its existing loan and security agreement (as amended prior to the Amendment, the “Existing Senior Credit Facility” and together with the Existing Mezzanine Credit Facility, the “Existing Credit Facilities”) with SVB, pursuant to which, the Company is no longer required to achieve minimum levels of trailing six-month net product revenues. Pursuant to the Second Amendments, The Term Loans will be interest-only through February 28, 2023, followed by 12 equal monthly payments of principal and interest. Other than as amended by the Second Amendments, the remaining terms of the Existing Credit Facilities remain in full force and effect. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). The Company’s functional currency is the U.S. dollar. The Company has been actively monitoring the novel coronavirus (“COVID-19”) pandemic and its impact globally. Management believes the financial results for the years ended December 31, 2021 and 2020, were not significantly impacted by COVID-19. In addition, management believes the remote working arrangements, travel restrictions and any other regulations imposed by various governmental jurisdictions have had limited impact on the Company’s ability to maintain internal operations during the year. The full extent to which the COVID-19 pandemic will directly or indirectly impact the Company’s business, results of operations and financial condition will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain it or treat COVID-19. As a direct result of COVID-19, the Company decided to delay the initiation of its previously planned Phase 2 clinical trial to evaluate VP-103 in subjects with plantar warts. |
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 reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. These estimates and assumptions are based on current facts, historical experience as well as other pertinent industry and regulatory authority information, including the potential future effects of COVID-19, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected. |
Segments | Segments Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating segment. |
Cash Cash Equivalents and Marketable Securities | Cash, Cash Equivalents and Marketable Securities The Company considers all highly liquid investments purchased with original maturities of 90 days or less at acquisition to be cash equivalents. Cash and cash equivalents include cash held in banks and money market mutual funds. The Company classifies its marketable securities as “available-for-sale”, pursuant to ASC 320 , Investments—Debt and Equity Securities , carries them at fair market value and classifies them as current assets on its balance sheets. There were no marketable securities with a maturity of greater than one year as of December 31, 2021 . Unrealized gains and losses on marketable debt securities are recorded as a separate component of accumulated other comprehensive gain or loss included in stockholders’ equity. |
Concentrations of Credit Risk and Off-Balance Sheet Risk | Concentrations of Credit Risk and Off-Balance Sheet Risk Cash, cash equivalents and marketable securities are financial instruments that are potentially subject to concentrations of credit risk. The Company’s deposits are in accounts at large financial institutions, and amounts may exceed federally insured limits. The Company believes it is not exposed to significant credit risk due to the financial strength of the depository institutions in which the funds are held. The Company has no financial instruments with off-balance sheet risk of loss. |
Property and Equipment | Property and Equipment Property and equipment is recorded at cost less accumulated depreciation. Depreciation and amortization is calculated using the straight line method over the expected useful life of the asset, after the asset is placed in service. The Company generally uses the following depreciable lives for its major classifications of property and equipment: Expenditures associated with upgrades and enhancements that improve, add functionality, or otherwise extend the life of property and equipment are capitalized, while expenditures that do not, such as repairs and maintenance, are expensed as incurred. The Company reviews long-lived assets, including property and equipment, for impairment whenever events or changes in business circumstances indicate that the carrying amount of an asset may not be fully recoverable. If the estimated undiscounted future cash flows expected to result from the use of the asset and its eventual disposition is less than its carrying amount, an impairment loss would be recognized if the carrying value of the asset exceeds its fair value. Fair value is generally determined using discounted cash flows. No impairment losses have been recorded during the years ended December 31, 2021 or 2020. Description Useful lives Machinery and equipment 3 - 5 years Office furniture and fixtures and equipment 3 years Leasehold improvements Lease Term Automobiles 3 years |
Revenue | Revenue In accordance with FASB’s ASC 606, Revenue from Contracts with Customers (“ASC 606”), the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, it performs the following five steps: (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 in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company 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 each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. License Revenues The Company’s revenues have been solely generated through licensing arrangements. The terms of the agreement typically include payments to the Company of one or more of the following: nonrefundable, up-front license fees: regulatory and commercial milestone payments; payments for manufacturing supply services; materials shipped to support development; and royalties on net sales of licensed products. In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under each of its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. The Company also assesses whether there is an option in a contract to acquire additional goods or services. An option gives rise to a performance obligation only if the option provides a material right to the customer that it would not receive without entering into that contract. Factors that the Company considers in evaluating whether an option represents a material right include, but are not limited to: (i) the overall objective of the arrangement, (ii) the benefit the collaborator might obtain from the arrangement without exercising the option, (iii) the cost to exercise the option (e.g. priced at a significant and incremental discount) and (iv) the likelihood that the option will be exercised. With respect to options determined to be performance obligations, the Company recognizes revenue when those future goods or services are transferred or when the options expire. The Company’s 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 regulatory or commercial milestone payments, the Company evaluates whether each milestone is considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. At each reporting period, the Company assesses the probability of achievement of each milestone under its current agreements. Royalties: If the Company is entitled to receive sales-based royalties from its collaborator, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, provided the reported sales are reliably measurable, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Manufacturing Supply and Research Services : Arrangements that include a promise for future supply of drug substance or drug product for either clinical development or commercial supply at the licensee’s discretion are generally considered as options. The Company assesses if these options provide a material right to the licensee and if so, they are accounted for as separate performance obligations. The Company receives payments from its licensees based on schedules established in each contract. Upfront payments are recorded as deferred revenue upon receipt, and may require deferral of revenue recognition to a future period until the Company performs its obligations under these arrangements. Amounts are recorded as accounts receivable when the Company’s right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the licensees and the transfer of the promised goods or services to the licensees will be one year or less. See Note 13 for a full discussion of the Company’s license revenue. |
Research and Development Costs | Research and Development Costs The Company’s research and development expenses consist primarily of costs associated with the Company’s clinical trials, salaries, payroll taxes, employee benefits, and equity-based compensation charges for those individuals involved in ongoing research and development efforts. Research and development costs are expensed as incurred. Advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made. |
Fair Value Measurement | Fair Value Measurement ASC 820, Fair Value Measurements , provides guidance on the development and disclosure of fair value measurements. Under this accounting guidance, fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability. The accounting guidance classifies fair value measurements in one of the following three categories for disclosure purposes: Level 1: Quoted prices in active markets for identical assets or liabilities. Level 2: Inputs other than Level 1 prices for similar assets or liabilities that are directly or indirectly observable in the marketplace. Level 3: Unobservable inputs which are supported by little or no market activity and values determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation. |
Comprehensive Loss | Comprehensive Loss Comprehensive 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. For the years ended December 31, 2021 and 2020 , comprehensive loss includes net loss and unrealized loss on marketable securities. |
Share Based Compensation | Stock-Based Compensation The Company accounts for stock-based compensation awards in accordance with ASC 718, Compensation –Stock Compensation . The Company uses the Black-Scholes option-pricing model to value its stock option awards. For stock-based awards granted to employees, non-employees and to members of the board of directors for their services, the Company estimates the grant date fair value of each option award and recognizes compensation expense on a straight-line basis over the vesting period of the award. The use of the Black‑Scholes option-pricing model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the common stock consistent with the expected life of the option, risk‑free interest rates, and, for grants prior to the Company’s IPO, the value of the common stock. The expected life of stock options was estimated using the “simplified method,” as the Company has limited historical information to develop reasonable expectations about future exercise patterns and post-vesting employment termination behavior for its stock options grants. The simplified method is based on the average of the vesting tranches and the contractual life of each grant. The Company historically has been a private company and lacks company-specific historical and implied volatility information. Therefore, it estimates its expected stock volatility based on the historical volatility of a publicly traded set of peer companies in addition to the volatility of the Company's stock. The risk-free interest rate is based on U.S. Treasury notes with a term approximating the expected life of the option. Expected dividend yield is zero based on the fact that the Company has never paid cash dividends and does no t expect to pay any cash dividends in the foreseeable future. The fair value of restricted stock awards are based on the closing price of the Company’s common stock on the grant date. |
Income Taxes | Income Taxes Income taxes are recorded in accordance with ASC 740, Income Taxes , which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Valuation allowances are provided, if based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit would more likely than not be realized assuming examination by the taxing authority. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. |
Net Loss Per Share | Net Loss Per Share Net 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 for the period. Diluted net loss per share excludes the potential impact of common stock options and unvested shares of restricted stock because their effect would be anti-dilutive due to the Company’s net loss. Since the Company had a net loss in each of the periods presented, basic and diluted net loss per common share are the same. The table below provides potential shares outstanding that were not included in the computation of diluted net loss per common share, as the inclusion of these securities would have been anti-dilutive: As of December 31, 2021 2020 Shares issuable upon exercise of stock options 3,443,817 2,901,908 Non-vested shares under restricted stock grants 425,000 475,000 |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework–Changes to the Disclosure Requirements for Fair Value Measurement , which makes a number of changes meant to add, modify or remove certain disclosure requirements associated with the movement amongst or hierarchy associated with Level 1, Level 2 and Level 3 fair value measurements. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. The adoption of this guidance as of January 1, 2020 did no t have an impact on the financial statements. In August 2018, the FASB issued ASU 2018-15, Intangibles–Goodwill and Other–Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement that is a Service Contract , which aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software (and hosting arrangements that include an internal-use software license). The guidance also requires the entity to expense the capitalized implementation costs of a hosting arrangement that is a service contract over the term of the hosting arrangement, which includes reasonably certain renewals. The adoption of this guidance as of January 1, 2020 did no t have an impact on the financial statements. As of January 1, 2020 the Company has adopted Accounting Standards Codification Topic 606, “Revenue from Contracts with Customers.” In accordance with FASB’s ASC 606, Revenue from Contracts with Customers (“ASC 606”), the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. The adoption of this guidance as of January 1, 2020 did not have an impact on the prior year financial statements. |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Schedule of Depreciable Lives of Property and Equipment | The Company generally uses the following depreciable lives for its major classifications of property and equipment: Description Useful lives Machinery and equipment 3 - 5 years Office furniture and fixtures and equipment 3 years Leasehold improvements Lease Term Automobiles 3 years |
Schedule of Potential Shares Outstanding not Included in Computation of Diluted Net Loss Per Common Share | The table below provides potential shares outstanding that were not included in the computation of diluted net loss per common share, as the inclusion of these securities would have been anti-dilutive: As of December 31, 2021 2020 Shares issuable upon exercise of stock options 3,443,817 2,901,908 Non-vested shares under restricted stock grants 425,000 475,000 |
Investments In Marketable Sec_2
Investments In Marketable Securities (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Investments [Abstract] | |
Schedule of Marketable Securities | Investments in marketable securities consisted of the following as of December 31, 2021 and 2020 (in thousands): As of December 31, 2021 Amortized Gross Gross Fair Cost Gains Losses Value U.S. treasury securities $ 15,272 — $ ( 15 ) $ 15,257 Commercial paper 28,980 — — 28,980 Asset-backed securities 10,379 — ( 14 ) 10,365 Total marketable securities $ 54,631 $ — $ ( 29 ) $ 54,602 As of December 31, 2020 Amortized Gross Gross Fair Cost Gains Losses Value U.S. treasury securities $ 11,607 $ 2 $ — $ 11,609 Commercial paper 41,674 — ( 1 ) 41,673 Asset-backed securities 1,502 — — 1,502 Total marketable securities $ 54,783 $ 2 $ ( 1 ) $ 54,784 |
Schedule of Fair Value by Level in Accordance with ASC 820 of Marketable Securities | The following tables presents fair value by level in accordance with ASC 820 (see Note 2) of the Company’s marketable securities (in thousands): Fair Value Measurement as of December 31, 2021 Level 1 Level 2 Level 3 Total U.S. treasury securities $ 15,257 $ — $ — $ 15,257 Commercial paper — 28,980 — 28,980 Asset-backed securities — 10,365 — 10,365 Total $ 15,257 $ 39,345 $ — $ 54,602 Fair Value Measurement as of December 31, 2020 Level 1 Level 2 Level 3 Total U.S. treasury securities $ 11,609 $ — $ — $ 11,609 Commercial paper — 41,673 — 41,673 Asset-backed securities — 1,502 — 1,502 Total $ 11,609 $ 43,175 $ — $ 54,784 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment, Net | Property and equipment, net consisted of (in thousands): As of December 31, 2021 2020 Machinery and equipment $ 737 $ 102 Office furniture and fixtures 303 117 Office equipment 301 52 Leasehold improvements 49 101 Automobiles 27 — Construction in process 2,731 2,857 4,148 3,229 Accumulated depreciation ( 254 ) ( 127 ) Total property and equipment, net $ 3,894 $ 3,102 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consisted of the following (in thousands): As of December 31, 2021 2020 Compensation and related costs $ 1,667 $ 1,338 Clinical trials and drug development 613 611 Professional fees 406 447 Interest expense 250 219 Construction in process 131 277 Machinery and equipment 124 — Other accrued expenses and other current liabilities 75 222 Total accrued expenses and other current liabilities $ 3,266 $ 3,114 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Schedule of Restricted Stock Awards Activities | The following table summarizes restricted stock awards: Weighted Average Grant Date Fair Number of Shares Value Non-vested as of December 31, 2019 1,148,859 $ 4.35 Granted 250,000 8.17 Forfeitures ( 499,429 ) 2.64 Vested ( 424,430 ) $ 11.27 Non-vested as of December 31, 2020 475,000 11.74 Granted — — Forfeitures ( 50,000 ) 12.29 Vested — — Non-vested as of December 31, 2021 425,000 $ 11.68 |
Schedule of Stock Based Compensation Expense | Stock-based compensation expense, which includes expense for both employees and non-employees, has been reported in the Company’s statements of operations for the years ended December 31, 2021 and 2020 as follows (in thousands): For the Year Ended December 31, 2021 2020 Research and development $ 1,513 $ 813 General and administrative 4,540 9,008 Total stock-based compensation $ 6,053 $ 9,821 |
Employee and Non-Employee Stock Options [Member] | |
Assumptions Used to Estimate Fair Value | The grant date fair value of employee and non-employee stock option awards is determined using the Black-Scholes option-pricing model. The following assumptions were used during the years ended December 31, 2021 and 2020 to estimate the fair value of employee and non-employee stock option awards: For the Year Ended December 31, 2021 2020 Exercise price $ 9.26 - $ 15.10 $ 6.56 - $ 15.91 Risk-free rate of interest 0.76 % - 1.24 % 0.27 % - 1.67 % Expected term (years) 6 6 Expected stock price volatility 87.14 % - 89.39 % 76.71 % - 85.97 % Dividend yield — — Weighted average grant date fair value $ 9.72 $ 7.00 |
Summary of Stock Option Activity | The following table summarizes the Company’s employee and non-employee stock option activity under the 2013 Plan and 2018 Plan for the years ended December 31, 2021 and 2020: Weighted average Number of Weighted average remaining contractual Aggregate intrinsic shares exercise price life (in years) value Outstanding as of December 31, 2019 1,914,545 $ 9.14 Options granted 1,193,956 10.35 Exercised ( 58,549 ) 7.73 Forfeited ( 125,377 ) 10.78 Expired ( 22,667 ) 12.00 Outstanding as of December 31, 2020 2,901,908 9.57 Options granted 1,222,786 13.28 Exercised ( 44,041 ) 12.67 Forfeited ( 462,617 ) 13.87 Expired ( 174,219 ) 13.84 Outstanding as of December 31, 2021 3,443,817 $ 10.05 7.8 $ 3,952,803 Options vested and exercisable 1,757,554 $ 8.48 6.7 $ 3,211,470 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Summary of Components of Lease Expense | The components of lease expense are as follows (in thousands): For the Year Ended 2021 2020 Finance lease cost: Amortization ROU assets $ 5 $ — Finance lease costs — — Interest on lease liabilities — — Total finance lease cost $ 5 $ — Operating lease Operating lease costs $ 346 $ 164 Short-term lease costs 21 22 Total operating lease $ 367 $ 186 |
Schedule of Maturities of Operating Lease | Maturities of the Company’s operating lease, excluding short-term leases as of December 31, 2021 are as follows (in thousands): December 31, 2021 Operating Finance 2022 $ 344 $ 7 2023 349 7 2024 355 8 2025 360 2 Thereafter 613 — Total lease payments 2,021 24 Less imputed interest ( 327 ) ( 2 ) Lease liability $ 1,694 $ 22 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Summary of Composition of Debt | The following table summarizes the composition of debt as reflected on the balance sheet as of December 31, 2021 (in thousands): Gross proceeds $ 40,000 Accrued final payment fee 3,750 Unamortized debt discount and issuance costs ( 2,057 ) Total short-term debt, net $ 41,693 |
Schedule of Aggregate Maturities of Debt | The aggregate maturities of debt as of December 31, 2021 are as follows (in thousands): 2022 $ 15,000 2023 20,000 2024 (1) 5,000 Total $ 40,000 (1) Excludes the final payment fee due at time of maturity. |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Schedule of Effective Income Tax Rate Reconciliation | Differences between the provision (benefit) for income taxes and income taxes at the statutory federal income tax rate are as follows (in thousands): For the Year Ended 2021 2020 Tax computed at statutory federal income tax rate $ ( 7,367 ) $ ( 8,966 ) State taxes, net of federal benefit ( 2,697 ) ( 2,938 ) Permanent items 282 1,283 R&D credits 26 ( 2,405 ) Other 205 ( 2 ) Change in valuation allowance 9,551 13,028 Income tax provision (benefit) $ — $ — |
Schedule of Components of Deferred Tax Assets and Liabilities | Significant components of the Company’s deferred tax assets and liabilities are as follows (in thousands): As of 2021 2020 Deferred tax assets: Net operating loss carryovers $ 31,514 $ 23,881 Share-based compensation 3,321 2,170 Tax credits 2,380 2,405 Amortization 678 — Accrued compensation 479 388 Lease liabilities 497 549 Other 16 12 Total deferred tax assets 38,885 29,405 Less valuation allowance ( 38,414 ) ( 28,863 ) Deferred tax asset, net of valuation allowance 471 542 Deferred tax liabilities: Right-of-use assets ( 466 ) ( 532 ) Fixed assets ( 5 ) ( 10 ) Total deferred tax liabilities ( 471 ) ( 542 ) Net deferred tax assets $ — $ — |
Organization and Description _2
Organization and Description of Business Operations - Additional Information (Detail) - USD ($) | Mar. 25, 2021 | Mar. 17, 2021 | Mar. 01, 2021 | Mar. 10, 2020 | Dec. 31, 2021 | Dec. 31, 2020 |
Description Of Business [Line Items] | ||||||
Accumulated deficit | $ (138,966,000) | $ (103,886,000) | ||||
Net proceeds from issuance | 28,118,000 | |||||
Cash, cash equivalents and marketable securities | 70,400,000 | |||||
Follow-on Public Offering [Member] | ||||||
Description Of Business [Line Items] | ||||||
Number of common shares sold | 2,033,899 | |||||
Share price | $ 14.75 | |||||
Net proceeds from issuance | $ 28,100,000 | |||||
Mezzanine Loan Agreement [Member] | Mezzanine Lenders [Member] | Term A Loan [Member] | ||||||
Description Of Business [Line Items] | ||||||
Borrowed amount | $ 35,000,000 | |||||
Mezzanine Loan Agreement [Member] | Mezzanine Lenders [Member] | Term B1 Loan [Member] | ||||||
Description Of Business [Line Items] | ||||||
Line of credit | $ 5,000,000 | |||||
Borrowed amount | $ 5,000,000 | |||||
Torii Agreement [Member] | Torii [Member] | ||||||
Description Of Business [Line Items] | ||||||
Obligated to make upfront payment | $ 11,500,000 |
Significant Accounting Polici_4
Significant Accounting Policies - Additional Information (Detail) | 12 Months Ended | |
Dec. 31, 2021USD ($)Segment | Dec. 31, 2020USD ($) | |
Significant Accounting Policies [Line Items] | ||
Number of operating segments | Segment | 1 | |
Marketable securities with maturity of greater than one year | $ 0 | |
Financial instruments with off-balance sheet risk of loss | 0 | |
Impairment losses | $ 0 | $ 0 |
Expected dividend yield | 0.00% | |
Expected dividend payments | $ 0 | |
Accounting Standards Update 2018-13 [Member] | ||
Significant Accounting Policies [Line Items] | ||
Change in accounting principle, accounting standards update, adopted [true false] | true | |
Change in accounting principle, accounting standards update, adoption date | Jan. 1, 2020 | |
Change in accounting principle, accounting Standards Update, immaterial effect [true false] | true | |
Accounting Standards Update 2018-15 [Member] | ||
Significant Accounting Policies [Line Items] | ||
Change in accounting principle, accounting standards update, adopted [true false] | true | |
Change in accounting principle, accounting standards update, adoption date | Jan. 1, 2020 | |
Change in accounting principle, accounting Standards Update, immaterial effect [true false] | true | |
Accounting Standards Update 2014-09 [Member] | ||
Significant Accounting Policies [Line Items] | ||
Change in accounting principle, accounting standards update, adopted [true false] | true | |
Change in accounting principle, accounting standards update, adoption date | Jan. 1, 2020 | |
Change in accounting principle, accounting Standards Update, immaterial effect [true false] | true |
Significant Accounting Polici_5
Significant Accounting Policies - Schedule of Depreciable Lives of Property and Equipment (Detail) | 12 Months Ended |
Dec. 31, 2021 | |
Machinery and Equipment [Member] | Minimum [Member] | |
Property Plant And Equipment [Line Items] | |
Estimated Useful Lives | 3 years |
Machinery and Equipment [Member] | Maximum [Member] | |
Property Plant And Equipment [Line Items] | |
Estimated Useful Lives | 5 years |
Office Furniture and Fixtures and Equipment [Member] | |
Property Plant And Equipment [Line Items] | |
Estimated Useful Lives | 3 years |
Leasehold Improvements [Member] | |
Property Plant And Equipment [Line Items] | |
Estimated Useful Lives | Lease Term |
Automobiles [Member] | |
Property Plant And Equipment [Line Items] | |
Estimated Useful Lives | 3 years |
Significant Accounting Polici_6
Significant Accounting Policies - Schedule of Potential Shares Outstanding not Included in Computation of Diluted Net Loss Per Common Share (Detail) - shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Shares issuable upon exercise of stock options [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Securities that could potentially dilute basic earnings per share | 3,443,817 | 2,901,908 |
Non-vested shares under restricted stock grants [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Securities that could potentially dilute basic earnings per share | 425,000 | 475,000 |
Investments in Marketable Sec_3
Investments in Marketable Securities - Schedule of Marketable Securities (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Marketable Securities [Line Items] | ||
Amortized Cost | $ 54,631 | $ 54,783 |
Gross Unrealized Gains | 2 | |
Gross Unrealized Losses | (29) | (1) |
Fair Value | 54,602 | 54,784 |
U.S. Treasury Securities [Member] | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 15,272 | 11,607 |
Gross Unrealized Gains | 2 | |
Gross Unrealized Losses | (15) | |
Fair Value | 15,257 | 11,609 |
Commercial Paper [Member] | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 28,980 | 41,674 |
Gross Unrealized Losses | (1) | |
Fair Value | 28,980 | 41,673 |
Asset Backed Securities [Member] | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 10,379 | 1,502 |
Gross Unrealized Losses | (14) | |
Fair Value | $ 10,365 | $ 1,502 |
Investments in Marketable Sec_4
Investments in Marketable Securities - Schedule of Fair Value by Level in Accordance with ASC 820 of Marketable Securities (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Marketable Securities [Line Items] | ||
Marketable securities | $ 54,602 | $ 54,784 |
Level 1 [Member] | ||
Marketable Securities [Line Items] | ||
Marketable securities | 15,257 | 11,609 |
Level 2 [Member] | ||
Marketable Securities [Line Items] | ||
Marketable securities | 39,345 | 43,175 |
U.S. Treasury Securities [Member] | ||
Marketable Securities [Line Items] | ||
Marketable securities | 15,257 | 11,609 |
U.S. Treasury Securities [Member] | Level 1 [Member] | ||
Marketable Securities [Line Items] | ||
Marketable securities | 15,257 | 11,609 |
Commercial Paper [Member] | ||
Marketable Securities [Line Items] | ||
Marketable securities | 28,980 | 41,673 |
Commercial Paper [Member] | Level 2 [Member] | ||
Marketable Securities [Line Items] | ||
Marketable securities | 28,980 | 41,673 |
Asset Backed Securities [Member] | ||
Marketable Securities [Line Items] | ||
Marketable securities | 10,365 | 1,502 |
Asset Backed Securities [Member] | Level 2 [Member] | ||
Marketable Securities [Line Items] | ||
Marketable securities | $ 10,365 | $ 1,502 |
Property and Equipment - Schedu
Property and Equipment - Schedule of Property and Equipment, Net (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 4,148 | $ 3,229 |
Accumulated depreciation | (254) | (127) |
Total property and equipment, net | 3,894 | 3,102 |
Machinery and Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 737 | 102 |
Office Furniture and Fixtures and Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 303 | 117 |
Office Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 301 | 52 |
Leasehold Improvements [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 49 | 101 |
Automobiles [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 27 | |
Construction in Progress [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 2,731 | $ 2,857 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 244,000 | $ 43,000 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) - PBM Capital Group, LLC [Member] - USD ($) | Oct. 01, 2019 | Dec. 02, 2015 | Dec. 31, 2021 | Dec. 31, 2020 |
Related Party Transaction [Line Items] | ||||
Services agreement initial term | 12 months | |||
Expenses incurred under services agreement | $ 60,000 | $ 60,000 | ||
Due to related party | 0 | 0 | ||
Amended Service Agreement [Member] | ||||
Related Party Transaction [Line Items] | ||||
Monthly management fee payable | $ 5,000 | |||
General and Administrative Expense [Member] | ||||
Related Party Transaction [Line Items] | ||||
Expenses incurred under services agreement | 36,000 | 36,000 | ||
Research and Development Expense [Member] | ||||
Related Party Transaction [Line Items] | ||||
Expenses incurred under services agreement | $ 24,000 | $ 24,000 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Accrued Liabilities, Current [Abstract] | ||
Compensation and related costs | $ 1,667 | $ 1,338 |
Clinical trials and drug development | 613 | 611 |
Professional fees | 406 | 447 |
Interest expense | 250 | 219 |
Construction in process | 131 | 277 |
Machinery and equipment | 124 | |
Other accrued expenses and other current liabilities | 75 | 222 |
Total accrued expenses and other current liabilities | $ 3,266 | $ 3,114 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - Crude Cantharidin Material [Member] - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2019 | |
Loss Contingencies [Line Items] | ||
Purchase agreement term | 5 years | |
Purchase Commitment | $ 0.8 | $ 1.8 |
Purchase commitment prepayment | $ 0.8 | $ 1.1 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | Mar. 25, 2021 | Dec. 31, 2021 | Dec. 31, 2020 |
Class of Stock [Line Items] | |||
Common stock, authorized | 200,000,000 | 200,000,000 | |
Common stock, par value | $ 0.0001 | $ 0.0001 | |
Common stock, voting right | one | ||
Net proceeds from issuance | $ 28,118 | ||
Follow-on Public Offering [Member] | |||
Class of Stock [Line Items] | |||
Number of common shares sold | 2,033,899 | ||
Share price | $ 14.75 | ||
Net proceeds from issuance | $ 28,100 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 12 Months Ended | ||||
Dec. 31, 2020 | Aug. 31, 2020 | Dec. 31, 2019 | Nov. 30, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Treasury stock, shares | 105,144 | 105,144 | 105,144 | |||
Amended and Restated Agreement [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Treasury stock, shares | 848,859 | |||||
Repurchase price | $ 0.0001714 | |||||
Non-vested, Number of shares, Vested | 424,430 | |||||
Repurchased and retired common stock | 424,429 | |||||
Shares issued, value, share-based payment arrangement | $ 4.8 | |||||
Stock repurchased and retired per share | $ 0.0001714 | |||||
Employee and Non-Employee Stock Options [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Stock options granted contractual term | 10 years | |||||
Stock option vesting term, description | through 2025 | |||||
Stock options expiration term, description | through 2031 | |||||
Weighted average grant date fair value per share | $ 9.72 | $ 7 | ||||
Total unrecognized compensation | $ 11.7 | |||||
Weighted-average stock option recognize period | 2 years 10 months 24 days | |||||
Employee and Non-Employee Stock Options [Member] | Share-based Compensation Award, Tranche One [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Percentage of stock subject to vesting (as a percent) | 25.00% | |||||
Stock vesting period | 12 months | |||||
Employee and Non-Employee Stock Options [Member] | Share-based Compensation Award, Tranche Two [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Percentage of stock subject to vesting (as a percent) | 75.00% | |||||
Stock vesting period | 12 months | |||||
Employee Stock Options [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Number of exercise shares vested stock options | 27,329 | |||||
Restricted Stock Units (RSUs) [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Stock vesting period | 1 year | |||||
Restricted Stock Units (RSUs) [Member] | Executive Officers [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Number of Shares, Granted | 250,000 | 300,000 | ||||
Restricted Stock Units (RSUs) [Member] | New Drug Application [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Percentage of stock subject to vesting (as a percent) | 50.00% | 50.00% | ||||
Restricted Stock Units (RSUs) [Member] | One Year Anniversary [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Percentage of stock subject to vesting (as a percent) | 50.00% | 50.00% | ||||
Restricted Stock [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Total unrecognized compensation related to nonvested restricted stock | $ 5 | |||||
Restricted Stock [Member] | Amended and Restated Agreement [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Non-vested, Number of shares, Vested | 424,430 | |||||
Stock repurchased and retired per share | $ 11.27 | |||||
Number of Shares, Granted | 250,000 | |||||
2018 Plan [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Common stock shares reserved for issuance | 3,738,199 | |||||
Shares issued | 2,198,198 | |||||
Number of years reserved share increase | 10 years | |||||
Annual Increase in number of common shares from January 1, 2019 through January 1, 2028 | 4.00% | |||||
Shares available for grant | 2,496,593 |
Stock-Based Compensation - Assu
Stock-Based Compensation - Assumptions Used to Estimate Fair Value Employee Stock Options (Detail) - $ / shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share Based Payment Award Stock Options Valuation Assumptions [Line Items] | ||
Dividend yield | 0.00% | |
Employee and Non-Employee Stock Options [Member] | ||
Share Based Payment Award Stock Options Valuation Assumptions [Line Items] | ||
Risk-free rate of interest, minimum | 0.76% | 0.27% |
Risk-free rate of interest, maximum | 1.24% | 1.67% |
Expected term (years) | 6 years | 6 years |
Expected stock price volatility, minimum | 87.14% | 76.71% |
Expected stock price volatility, maximum | 89.39% | 85.97% |
Weighted average grant date fair value | $ 9.72 | $ 7 |
Employee and Non-Employee Stock Options [Member] | Minimum [Member] | ||
Share Based Payment Award Stock Options Valuation Assumptions [Line Items] | ||
Exercise price | 9.26 | 6.56 |
Employee and Non-Employee Stock Options [Member] | Maximum [Member] | ||
Share Based Payment Award Stock Options Valuation Assumptions [Line Items] | ||
Exercise price | $ 15.10 | $ 15.91 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity (Detail) - 2013 and 2018 Equity Incentive Plan [Member] - Employee and Non-Employee Stock Options [Member] - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Number of shares, Outstanding Beginning Balance | 2,901,908 | 1,914,545 |
Number of shares, Options granted | 1,222,786 | 1,193,956 |
Number of shares, Exercised | (44,041) | (58,549) |
Number of shares, Forfeited | (462,617) | (125,377) |
Number of shares, Expired | (174,219) | (22,667) |
Number of shares, Outstanding Ending Balance | 3,443,817 | 2,901,908 |
Number of shares, Options vested and exercisable Ending Balance | 1,757,554 | |
Weighted average exercise price, Outstanding Beginning Balance | $ 9.57 | $ 9.14 |
Weighted average exercise price, Options granted | 13.28 | 10.35 |
Weighted average exercise price, Exercised | 12.67 | 7.73 |
Weighted average exercise price, Forfeited | 13.87 | 10.78 |
Weighted average exercise price, Expired | 13.84 | 12 |
Weighted average exercise price, Outstanding Ending Balance | 10.05 | $ 9.57 |
Weighted average exercise price, Options vested and exercisable Ending Balance | $ 8.48 | |
Weighted average remaining contractual life (in years), Outstanding | 7 years 9 months 18 days | |
Weighted average remaining contractual life (in years), Options vested and exercisable | 6 years 8 months 12 days | |
Aggregate intrinsic value, Outstanding | $ 3,952,803 | |
Aggregate intrinsic value, Options vested and exercisable Ending Balance | $ 3,211,470 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Restricted Stock Awards Activities (Detail) - Amended and Restated Agreement [Member] - $ / shares | 1 Months Ended | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Non-vested, Number of shares, Vested | (424,430) | ||
Non-vested, Weighted average grant date fair value, Vested | $ 0.0001714 | ||
Restricted Stock [Member] | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Non-vested, Number of Shares, Beginning Balance | 475,000 | 1,148,859 | |
Non-vested, Number of Shares, Granted | 250,000 | ||
Non-vested, Number of shares, Forfeitures | (50,000) | (499,429) | |
Non-vested, Number of shares, Vested | (424,430) | ||
Non-vested, Number of Shares, Ending Balance | 475,000 | 425,000 | 475,000 |
Non-vested, Weighted Average Grant Date Fair Value, Beginning Balance | $ 11.74 | $ 4.35 | |
Non-vested, Weighted Average Grant Date Fair Value, Granted | 8.17 | ||
Non-vested, Weighted average grant date fair value, Forfeitures | 12.29 | 2.64 | |
Non-vested, Weighted average grant date fair value, Vested | 11.27 | ||
Non-vested, Weighted Average Grant Date Fair Value, Ending Balance | $ 11.74 | $ 11.68 | $ 11.74 |
Stock-Based Compensation - Sc_2
Stock-Based Compensation - Schedule of Stock Based Compensation Expense (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total stock-based compensation | $ 6,053 | $ 9,821 |
Research and Development [Member] | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total stock-based compensation | 1,513 | 813 |
General and Administrative [Member] | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total stock-based compensation | $ 4,540 | $ 9,008 |
Leases - Additional Information
Leases - Additional Information (Detail) | Mar. 12, 2020ft² | Jul. 01, 2019ft² | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Sep. 01, 2020USD ($) |
Lessee Lease Description [Line Items] | |||||
Operating lease expiration | 2021-05 | ||||
First amendments date | Mar. 12, 2020 | ||||
Lease expiration date | Sep. 1, 2027 | ||||
Operating lease right of use asset | $ 1,608,000 | $ 1,836,000 | $ 1,900,000 | ||
Operating lease liability | 1,694,000 | $ 1,900,000 | |||
Operating lease liability, current | $ 244,600 | $ 198,000 | |||
Financing leases expiration year | 2025 | ||||
Financing vehicle lease, net | $ 22,000 | ||||
Operating lease, remaining lease term | 5 years 8 months 12 days | ||||
Finance lease, remaining lease term | 3 years 3 months 18 days | ||||
Operating lease, discount rate | 6.25% | ||||
Finance lease, discount rate | 4.35% | ||||
Pennsylvania [Member] | |||||
Lessee Lease Description [Line Items] | |||||
Lease agreement commencement date | Jul. 1, 2019 | ||||
Area of office space for lease | ft² | 5,829 | ||||
Original Premises [Member] | |||||
Lessee Lease Description [Line Items] | |||||
Area of office space for lease | ft² | 5,372 | ||||
Total Rentable Premise [Member] | |||||
Lessee Lease Description [Line Items] | |||||
Area of office space for lease | ft² | 11,201 | ||||
Landlord's Operating Expense [Member] | |||||
Lessee Lease Description [Line Items] | |||||
Operating lease, base rent | $ 2,400,000 |
Leases - Summary of Components
Leases - Summary of Components of Lease Expense (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Leases [Abstract] | ||
Amortization ROU assets | $ 5 | |
Total finance lease cost | 5 | |
Operating lease costs | 346 | $ 164 |
Short-term lease costs | 21 | 22 |
Total operating lease | $ 367 | $ 186 |
Leases - Schedule of Maturities
Leases - Schedule of Maturities of Operating Lease (Detail) - USD ($) | Dec. 31, 2021 | Sep. 01, 2020 |
Leases [Abstract] | ||
Finance Lease, Year one | $ 7,000 | |
Finance Lease, Year Two | 7,000 | |
Finance Lease, Year Three | 8,000 | |
Finance Lease, Year Four | 2,000 | |
Finance Lease, Total lease payments | 24,000 | |
Less Finance Lease imputed interest | (2,000) | |
Finance Lease, Lease liability | 22,000 | |
Operating Lease, Year one | 344,000 | |
Operating Lease, Year Two | 349,000 | |
Operating Lease, Year Three | 355,000 | |
Operating Lease, Year Four | 360,000 | |
Operating Lease, After Year Four | 613,000 | |
Operating Lease, Total lease payments | 2,021,000 | |
Less Operating Lease, imputed interest | (327,000) | |
Operating Lease, Lease liability | $ 1,694,000 | $ 1,900,000 |
Debt - Additional Information (
Debt - Additional Information (Detail) - USD ($) | Mar. 01, 2021 | Oct. 26, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Mar. 31, 2020 | Mar. 10, 2020 |
Debt Instrument [Line Items] | ||||||
Term loans, frequency of periodic payments | 24 equal monthly | |||||
Debt instrument, covenant description | Under the Loan Agreements, as amended, the Company is subject to a number of affirmative and restrictive covenants, including covenants regarding delivery of financial statements, maintenance of inventory, payment of taxes, maintenance of insurance, protection of intellectual property rights, dispositions of property, business combinations or acquisitions, incurrence of additional indebtedness or liens, investments and transactions with affiliates among other customary covenants. As of December 31, 2021 the Company is in compliance with all covenants. | |||||
Debt instrument, covenant compliance | As of December 31, 2021 the Company is in compliance with all covenants. | |||||
Final payment fee | $ 40,000,000 | |||||
Mezzanine Loan Agreement [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, final payment fee payable | $ 3,750,000 | |||||
Debt instrument, prepayment written notice period | 5 days | |||||
Mezzanine Loan Agreement [Member] | Term Loan Prepaid Between October 27, 2021 and October 26, 2022 [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, prepayment fee | $ 1,000,000 | |||||
Mezzanine Loan Agreement [Member] | Term Loan Prepaid Between October 27, 2022 and October 26, 2023 [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, prepayment fee | 500,000 | |||||
Mezzanine Loan Agreement [Member] | Term Loan Prepaid After October 26, 2023 [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, prepayment fee | 0 | |||||
Mezzanine Loan Agreement [Member] | Mezzanine Lenders [Member] | Term Loans [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Maximum borrowing capacity | $ 50,000,000 | |||||
Mezzanine Loan Agreement [Member] | Silicon Valley Bank (Senior Lender) [Member] | Revolving Loans [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Maximum borrowing capacity | $ 5,000,000 | |||||
Senior Loan Agreement [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Maximum borrowing capacity | $ 5,000,000 | |||||
Line of credit, maximum borrowing base percentage of eligible accounts receivable | 85.00% | |||||
Loans, maturity date | Mar. 1, 2024 | |||||
Term loans, payment terms | The Term Loans will be interest-only through March 31, 2022, followed by 24 equal monthly payments of principal and interest. | |||||
Loans, interest rate terms | The Term Loans will bear interest at a floating per annum rate equal to the greater of (i) 7.25% and (ii) the sum of (a) the prime rate reported in The Wall Street Journal on the last business day of the month that immediately precedes the month in which the interest will accrue, plus (b) 2.50%. | |||||
Loans, interest rate | 7.25% | |||||
Credit line, early termination notice period | 3 days | |||||
Debt discount and issuance costs | $ 4,300,000 | |||||
Interest expense | 4,300,000 | $ 3,000,000 | ||||
Interest on term loan | 2,900,000 | 2,100,000 | ||||
Non-cash interest expense | 1,400,000 | $ 900,000 | ||||
Senior Loan Agreement [Member] | Prime Rate [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Loans, variable rate | 2.50% | |||||
Senior Loan Agreement [Member] | Term Loans [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Borrowed amount | $ 5,000,000 | |||||
Line of credit | $ 35,000,000 | |||||
Senior Loan Agreement [Member] | Term Loans [Member] | Contra-Liability [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Final payment fee | $ 3,800,000 | |||||
Senior Loan Agreement [Member] | Revolving Loans [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Loans, interest rate terms | The Revolving Loans will bear interest at a floating per annum rate equal to the greater of (i) 6.00% and (ii) the sum of (a) the prime rate reported in The Wall Street Journal on the last business day of the month that immediately precedes the month in which the interest will accrue, plus (b) 1.25%. | |||||
Loans, interest rate | 6.00% | |||||
Credit line, early termination fee amount | $ 50,000 | |||||
Senior Loan Agreement [Member] | Revolving Loans [Member] | Other Non-Current Assets [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt discount and issuance costs | $ 100,000 | |||||
Senior Loan Agreement [Member] | Revolving Loans [Member] | Prime Rate [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Loans, variable rate | 1.25% |
Debt - Summary of Composition o
Debt - Summary of Composition of Debt (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Debt Instrument [Line Items] | ||
Gross proceeds | $ 41,693 | $ 35,315 |
Senior Loan Agreement [Member] | ||
Debt Instrument [Line Items] | ||
Gross proceeds | 40,000 | |
Accrued final payment fee | 3,750 | |
Unamortized debt discount and issuance costs | (2,057) | |
Total short-term debt, net | $ 41,693 |
Debt - Schedule of Aggregate Ma
Debt - Schedule of Aggregate Maturities of Debt (Detail) $ in Thousands | Dec. 31, 2021USD ($) |
Debt Disclosure [Abstract] | |
2022 | $ 15,000 |
2023 | 20,000 |
2024 | 5,000 |
Long-term debt | $ 40,000 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Income Taxes at U.S. Federal Statutory Rate to Provision for Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
Tax computed at statutory federal income tax rate | $ (7,367) | $ (8,966) |
State taxes, net of federal benefit | (2,697) | (2,938) |
Permanent items | 282 | 1,283 |
R&D credits | 26 | (2,405) |
Other | 205 | (2) |
Change in valuation allowance | $ 9,551 | $ 13,028 |
Income Taxes - Significant Comp
Income Taxes - Significant Components of Deferred Tax Assets and Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred tax assets: | ||
Net operating loss carryovers | $ 31,514 | $ 23,881 |
Share-based compensation | 3,321 | 2,170 |
Tax credits | 2,380 | 2,405 |
Amortization | 678 | |
Accrued compensation | 479 | 388 |
Lease liabilities | 497 | 549 |
Other | 16 | 12 |
Total deferred tax assets | 38,885 | 29,405 |
Less valuation allowance | (38,414) | (28,863) |
Deferred tax asset, net of valuation allowance | 471 | 542 |
Deferred tax liabilities: | ||
Right-of-use assets | (466) | (532) |
Fixed assets | (5) | (10) |
Total deferred tax liabilities | $ (471) | $ (542) |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | |||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2017 | |
Operating Loss Carryforwards [Line Items] | ||||
Federal and state research and development carryforwards | $ 2,400,000 | |||
Equity ownership period | 3 years | |||
Unrecognized tax benefits | $ 1,500,000 | |||
Unrecognized tax benefits, income tax penalties and interest accrued | $ 0 | $ 0 | ||
Unrecognized tax benefits, income tax penalties and interest expense | 0 | 0 | ||
Deferred tax benefit | $ 2,400,000 | $ 2,400,000 | ||
Minimum [Member] | ||||
Operating Loss Carryforwards [Line Items] | ||||
Ownership percentage | 50.00% | |||
Federal [Member] | ||||
Operating Loss Carryforwards [Line Items] | ||||
Operating loss carryforwards | $ 109,000,000 | $ 6,900,000 | ||
State [Member] | ||||
Operating Loss Carryforwards [Line Items] | ||||
Operating loss carryforwards | $ 110,900,000 | |||
Net Operating Loss Carryforwards Generated in 2016 and 2017 [Member] | ||||
Operating Loss Carryforwards [Line Items] | ||||
Federal and state net operating loss carryforwards, expiration date | 2033 |
License and Collaboration Agr_2
License and Collaboration Agreements - Additional Information (Detail) - USD ($) $ in Thousands | Mar. 17, 2021 | Apr. 30, 2021 | Feb. 28, 2021 | Dec. 31, 2020 | Aug. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 |
License And Collaboration Agreements [Line Items] | |||||||
Research and development expense | $ 15,929 | $ 15,673 | |||||
Ltyix [Member] | |||||||
License And Collaboration Agreements [Line Items] | |||||||
Payments upon achievements of milestone | $ 111,000 | ||||||
One time up front license fee | $ 2,300 | 300 | |||||
Research and development expense | $ 2,300 | 300 | |||||
Percentage of royalty income shared | 50.00% | ||||||
Option Agreement [Member] | Torii [Member] | |||||||
License And Collaboration Agreements [Line Items] | |||||||
Consideration receivable to secure exclusive option | $ 500 | ||||||
Deferred revenue | $ 500 | $ 500 | |||||
Torii Agreement [Member] | Torii [Member] | |||||||
License And Collaboration Agreements [Line Items] | |||||||
Received payment | $ 11,500 | $ 500 | |||||
Payments upon achievements of milestone | $ 58,000 | ||||||
Torii Agreement [Member] | Torii [Member] | Minimum [Member] | |||||||
License And Collaboration Agreements [Line Items] | |||||||
Mid Percentage of transfer price payments for supply of product net sales | 30.00% | ||||||
Torii Agreement [Member] | Torii [Member] | Maximum [Member] | |||||||
License And Collaboration Agreements [Line Items] | |||||||
Mid Percentage of transfer price payments for supply of product net sales | 40.00% |
Subsequent Event - Additional I
Subsequent Event - Additional Information - (Detail) | Mar. 01, 2022 | Oct. 26, 2020 |
Subsequent Event [Line Items] | ||
Term loans, frequency of periodic payments | 24 equal monthly | |
Second Mezzanine Loan Amendment [Member] | Subsequent Event [Member] | ||
Subsequent Event [Line Items] | ||
Term loans, payment terms | Term Loans will be interest-only through February 28, 2023, followed by 12 equal monthly payments of principal and interest. | |
Term loans, frequency of periodic payments | 12 equal monthly |