Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2021 | May 12, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2021 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q1 | |
Entity Registrant Name | TREVI THERAPEUTICS, INC. | |
Entity Central Index Key | 0001563880 | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Trading Symbol | TRVI | |
Entity Common Stock, Shares Outstanding | 19,927,348 | |
Entity Shell Company | false | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Small Business | true | |
Entity File Number | 001-38886 | |
Entity Tax Identification Number | 45-0834299 | |
Entity Address, Address Line One | 195 Church Street | |
Entity Address, Address Line Two | 14th Floor | |
Entity Address, City or Town | New Haven | |
Entity Address, State or Province | CT | |
Entity Address, Postal Zip Code | 06510 | |
City Area Code | 203 | |
Local Phone Number | 304-2499 | |
Entity Interactive Data Current | Yes | |
Entity Incorporation, State or Country Code | DE | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Title of 12(b) Security | Common Stock, $0.001 par value per share | |
Security Exchange Name | NASDAQ |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 41,570 | $ 45,001 |
Prepaid expenses and other current assets | 589 | 1,268 |
Total current assets | 42,159 | 46,269 |
Deferred offering costs | 162 | 284 |
Operating lease right-of-use asset | 204 | 227 |
Security deposits and other non-current assets | 248 | 248 |
Property, equipment and leasehold improvements, net | 91 | 103 |
Total assets | 42,864 | 47,131 |
Current liabilities: | ||
Accounts payable | 801 | 2,016 |
Accrued expenses | 3,847 | 3,426 |
Term loan - current portion | 583 | |
Operating lease liability - current portion | 107 | 113 |
Total current liabilities | 5,338 | 5,555 |
Term loan - long term portion | 13,516 | 13,954 |
Term loan derivative liability | 202 | 196 |
Operating lease liability - long term portion | 123 | 144 |
Total liabilities | 19,179 | 19,849 |
Commitments and contingencies (Note 11) | ||
Stockholders’ equity | ||
Preferred stock: $0.001 par value; 5,000,000 shares authorized at March 31, 2021 and December 31, 2020; no shares issued or outstanding at March 31, 2021 or December 31, 2020. | ||
Common stock: $0.001 par value; 200,000,000 shares authorized at March 31, 2021 and December 31, 2020; and 19,914,407 and 18,546,786 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively. | 20 | 19 |
Additional paid-in capital | 179,013 | 174,240 |
Accumulated deficit | (155,348) | (146,977) |
Total stockholders’ equity | 23,685 | 27,282 |
Total liabilities and stockholders’ equity | $ 42,864 | $ 47,131 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2021 | Dec. 31, 2020 |
Statement Of Financial Position [Abstract] | ||
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 |
Preferred Stock, Shares Authorized | 5,000,000 | 5,000,000 |
Preferred Stock, Shares Issued | 0 | 0 |
Preferred Stock, Shares Outstanding | 0 | 0 |
Common Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 |
Common Stock, Shares Authorized | 200,000,000 | 200,000,000 |
Common Stock, Shares, Issued | 19,914,407 | 18,546,786 |
Common Stock, Shares, Outstanding | 19,914,407 | 18,546,786 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Operating expenses: | ||
Research and development | $ 5,589 | $ 6,019 |
General and administrative | 2,500 | 2,620 |
Total operating expenses | 8,089 | 8,639 |
Loss from operations | (8,089) | (8,639) |
Other (expense) income: | ||
Change in fair value of term loan derivative liability | (6) | |
Interest income | 3 | 157 |
Interest expense | (294) | |
Total other (expense) income, net | (297) | 157 |
Loss before income tax benefit | (8,386) | (8,482) |
Income tax benefit | 15 | 9 |
Net loss | $ (8,371) | $ (8,473) |
Basic and diluted net loss per common share outstanding | $ (0.43) | $ (0.48) |
Weighted average common shares used in net loss per share attributable to common stockholders, basic and diluted | 19,417,038 | 17,834,570 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] |
Beginning Balance at Dec. 31, 2019 | $ 54,545 | $ 18 | $ 168,746 | $ (114,219) |
Beginning Balance (in shares) at Dec. 31, 2019 | 17,834,570 | |||
Stock-based compensation | 730 | 730 | ||
Net loss | (8,473) | (8,473) | ||
Ending Balance at Mar. 31, 2020 | 46,802 | $ 18 | 169,476 | (122,692) |
Ending Balance (in shares) at Mar. 31, 2020 | 17,834,570 | |||
Beginning Balance at Dec. 31, 2019 | 54,545 | $ 18 | 168,746 | (114,219) |
Beginning Balance (in shares) at Dec. 31, 2019 | 17,834,570 | |||
Net loss | (32,800) | |||
Ending Balance at Dec. 31, 2020 | 27,282 | $ 19 | 174,240 | (146,977) |
Ending Balance (in shares) at Dec. 31, 2020 | 18,546,786 | |||
Stock-based compensation | 718 | 718 | ||
Issuance of common stock value, net of underwriting discounts and commissions and issuance costs | 4,056 | $ 1 | 4,055 | |
Issuance of common stock shares, net of underwriting discounts and commissions and issuance costs | 1,367,621 | |||
Net loss | (8,371) | (8,371) | ||
Ending Balance at Mar. 31, 2021 | $ 23,685 | $ 20 | $ 179,013 | $ (155,348) |
Ending Balance (in shares) at Mar. 31, 2021 | 19,914,407 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 | |
Operating activities | |||
Net loss | $ (8,371) | $ (8,473) | $ (32,800) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation | 13 | 10 | |
Change in fair value of term loan derivative liability | 6 | ||
Accretion/accrual of term loan discounts and debt issuance costs | 145 | ||
Stock-based compensation | 718 | 730 | |
Changes in operating assets and liabilities: | |||
Prepaid expenses and other current assets | 679 | 1,059 | |
Accounts payable | (1,215) | 594 | |
Accrued expenses and other | 447 | 1,407 | |
Net cash used in operating activities | (7,578) | (4,673) | |
Financing activities | |||
Proceeds from at-the-market sales, net of commissions | 4,178 | ||
Payments of offering costs | (31) | ||
Net cash provided by financing activities | 4,147 | ||
Net decrease in cash and cash equivalents | (3,431) | (4,673) | |
Cash and cash equivalents at beginning of period | 45,001 | 57,313 | 57,313 |
Cash and cash equivalents at end of period | $ 41,570 | $ 52,640 | $ 45,001 |
Nature of the Business
Nature of the Business | 3 Months Ended |
Mar. 31, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Nature of the Business | 1. Trevi Therapeutics, Inc. (“Trevi” or the “Company”) is a clinical-stage biopharmaceutical company focused on the development and commercialization of the investigational therapy Haduvio (nalbuphine ER) to treat serious neurologically mediated conditions. The Company is currently developing Haduvio for the treatment of chronic pruritus associated with prurigo nodularis and chronic cough in patients with idiopathic pulmonary fibrosis (“IPF”). The Company is also developing Haduvio in levodopa-induced dyskinesia (“LID”) in patients with Parkinson’s disease. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems. Due to nalbuphine’s mechanism of action as a modulator of opioid receptors, the Company believes Haduvio has the potential to be effective in treating each of these conditions. Haduvio is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed κ-opioid receptor agonist and μ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The κ- and μ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine’s mechanism of action also mitigates the risk of abuse associated with μ-opioid agonists because it antagonizes, or blocks, the μ-opioid receptor. Nalbuphine is currently the only opioid approved for marketing that is not classified as a controlled substance in the United States and most of Europe. Liquidity In accordance with Accounting Standards Update (“ASU”) No. 2014-15, Disclosures of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40) (“ASU No. 2014-15”) The Company’s Condensed Consolidated Financial Statements have been prepared on a going concern basis, which contemplates the continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business. Since inception, the Company has financed its operations primarily through private placements of convertible preferred stock and convertible notes prior to its initial public offering, borrowings under its prior term loan facility, proceeds from its initial public offering and concurrent private placement completed in May 2019, sales of its common stock pursuant to the sales agreement with SVB Leerink LLC it entered into in June 2020 (the “ATM Sales Agreement”) (Note 7) and the term loan facility with Silicon Valley Bank that the Company entered into in August 2020. The Company has incurred recurring losses since inception, including net losses of $8.4 million for the three months ended March 31, 2021 and $32.8 million for the year ended December 31, 2020. As of March 31, 2021, the Company had cash and cash equivalents of $41.6 million. The Company has incurred losses and negative cash flows from operations and had an accumulated deficit of $155.3 million as of March 31, 2021. The Company expects to continue to generate losses for the foreseeable future. As of May 13, 2021, the date of issuance of these Condensed Consolidated Financial Statements, the Company expects that its cash and cash equivalents as of March 31, 2021, will not be sufficient to fund its current business plan including related operating expenses and capital expenditure requirements through at least 12 months from the date of issuance of these Condensed Consolidated Financial Statements. The Company plans to seek to address this condition by raising additional capital to finance its operations. The future viability of the Company is dependent on its ability to raise additional capital to finance its operations. Although the Company has been successful in raising capital in the past, there is no assurance that it will be successful in obtaining such additional financing. Therefore, it is not considered probable, as defined in ASU No. 2014-15, that the Company’s plans to raise additional capital will alleviate the substantial doubt regarding its ability to continue as a going concern. To execute its business plans, the Company will need substantial funding to support its continuing operations and pursue its growth strategy. Until such time as the Company can generate significant revenue from product sales, if ever, the Company expects to finance its operations through the sale of common stock in public offerings and/or private placements, debt financings or other capital sources, including collaborations with other companies or other strategic transactions. The Company may not be able to obtain financing when needed, on acceptable terms or at all. The terms of any financing may adversely affect the holdings or the rights of the Company’s stockholders. If the Company is unable to obtain funding, the Company could be forced to delay, reduce or abandon its product development programs or commercialization efforts, which could adversely affect its business prospects. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Basis of Presentation The accompanying unaudited interim Condensed Consolidated Financial Statements for the three months ended March 31, 2021 and 2020 included herein, have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim information. Certain prior year balances have been reclassified to conform to the current year presentation. Such reclassifications did not affect loss from operations or net loss. Certain information and footnote disclosures typically prepared in accordance with GAAP have been condensed or omitted pursuant to SEC rules and regulations. The accompanying unaudited Condensed Consolidated Financial Statements and notes should be read in conjunction with the audited consolidated financial statements and related notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 (the “Annual Report on Form 10-K”). The accompanying Condensed Consolidated Financial Statements include the accounts of Trevi Therapeutics, Inc. and its wholly-owned subsidiary Trevi Therapeutics Limited. Intercompany balances and transactions have been eliminated. All amounts presented are in thousands of dollars, except share and per share amounts, unless noted otherwise. The Company has evaluated events occurring subsequent to March 31, 2021 for potential recognition or disclosure in the Condensed Consolidated Financial Statements and concluded there were no subsequent events that required recognition or disclosure. 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 at the date of the financial statements and the reported amounts of the expenses during the reporting periods. Significant estimates and assumptions reflected in these Condensed Consolidated Financial Statements include, but are not limited to, the recognition of research and development (“R&D”) expenses, the valuation of stock-based awards and the valuation allowance of deferred tax assets resulting from net operating losses. In addition, management’s assessment of the Company’s ability to continue as a going concern involves the estimation of the amount and timing of future cash inflows and outflows. On an ongoing basis, management evaluates its estimates in light of changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates. The inputs into the Company’s estimates also considered the economic implications of COVID-19 on the Company’s estimates. Unaudited Interim Financial Information The accompanying interim Condensed Consolidated Balance Sheet as of March 31, 2021 and the Condensed Consolidated Statements of Operations, the Condensed Consolidated Statements of Stockholders’ Equity and the Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2021 and 2020 are unaudited. The unaudited interim Condensed Consolidated Financial Statements have been prepared on the same basis as the audited annual consolidated financial statements and, in the Company’s opinion, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statements of its financial position as of March 31, 2021 and the results of its operations and its cash flows for the three months ended March 31, 2021 and 2020. The results for the three months ended March 31, 2021 and 2020 are not necessarily indicative of results to be expected for the year ending December 31, 2021, or any other interim period, or any future year or period. Cash Equivalents The Company classifies short-term, highly liquid investments with an original term of three months or less at the date of purchase as cash equivalents. Fair Value Measurements The Company’s financial instruments have consisted of cash and cash equivalents, other current assets, accounts payable, accrued expenses, term loans and term loan derivative liability (Note 6). Fair instruments. The term loan derivative liability is recorded at fair value, which is estimated utilizing a probability-weighted cash flow approach (Note 6). Current accounting guidance defines fair value, establishes a framework for measuring fair value in accordance with Accounting Standards Codification (“ASC”) 820, Fair Value Measurements and Disclosures Level 1—Observable inputs—quoted prices in active markets for identical assets and liabilities. Level 2—Observable inputs other than the quoted prices in active markets for identical assets and liabilities—such as quoted prices for similar instruments, quoted prices for identical or similar instruments in inactive markets, or other inputs that are observable or can be corroborated by observable market data. Level 3—Unobservable inputs—includes amounts derived from valuation models where one or more significant inputs are unobservable and require the company to develop relevant assumptions. The following table summarizes the financial assets and financial liabilities measured at fair value on a recurring basis and the basis for that measurement, by level within the fair value hierarchy (Note 6): Level 1 Level 2 Level 3 March 31, 2021 Financial assets carried at fair value: Money market funds (1) $ 40,772 $ — $ — Financial liabilities carried at fair value: Term loan derivative liability $ — $ — $ 202 December 31, 2020 Financial assets carried at fair value: Money market funds (1) $ 44,095 $ — $ — Financial liabilities carried at fair value: Term loan derivative liability $ — $ — $ 196 (1) The following table represents a roll-forward of the fair value of Level 3 instruments (significant unobservable inputs): March 31, December 31, 2021 2020 Financial liabilities Balance at beginning of year $ 196 $ 187 Change in fair value of term loan derivative liability 6 9 Ending balance $ 202 $ 196 Property, Equipment and Leasehold Improvements Property, equipment and leasehold improvements (consisting of furniture, computer and office equipment and leasehold improvements) are stated at cost, net of accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the respective assets (three years for computer equipment, five years for furniture and office equipment, and the shorter of the term of the lease or useful life for leasehold improvements). Impairment of Long-Lived Assets ASC 360, Property, Plant, and Equipment, Foreign Currency Transactions The Company, at times, contracts with vendors and consultants outside of the United States, resulting in liabilities denominated in foreign currency. The transactions are recorded in U.S. dollars on the transaction dates and any currency fluctuation through the payment date is recorded as currency gains or losses in the Condensed Consolidated Statements of Operations. Deferred Offering Costs The Company capitalizes certain legal, professional, accounting and other third-party fees that are directly associated with in-process equity financings as deferred offering costs until such financings are consummated. After consummation of an equity financing, these costs are recorded in stockholders’ equity as a reduction of additional paid-in capital generated as a result of the offering. Should the planned equity financing no longer be considered probable of being consummated, the deferred offering costs are expensed immediately as a charge to operating expenses. Deferred offering costs relating to the Company’s ATM Sales Agreement were $162 Research and Development Expenses All of the Company’s research and development expenses consist of expenses incurred in connection with the development of Haduvio. These expenses include certain payroll and personnel expenses, including stock-based compensation, consulting costs, contract manufacturing costs and fees paid to clinical research organizations (“CROs”) to conduct certain research and development activities on the Company’s behalf. The Company does not allocate its costs by each indication for which it is developing Haduvio, as a significant amount of the Company’s development activities broadly support all indications. In addition, several of the Company’s departments support the Company’s Haduvio drug candidate development program and the Company does not identify internal costs for each potential indication. The Company expenses both internal and external research and development expenses as they are incurred. Accrued Research and Development Expenses The Company has entered into agreements with CROs, contract manufacturing organizations (“CMOs”) and other companies that provide services in connection with the Company’s research and development activities. The Company’s research and development accruals are estimated based on the level of services performed, progress of the studies, including the phase or completion of events, and contracted costs. The estimated costs of research and development provided, but not yet invoiced, are included in accrued expenses on the Condensed Consolidated Balance Sheets. If the actual timing of the performance of services or the level of effort varies from the original estimates, the Company will adjust the accrual accordingly. Payments made to CROs, CMOs and other companies under these arrangements in advance of the performance of the related services are recorded as prepaid expenses or as non-current deposits, as applicable, and are recognized as expenses as the goods are delivered or the related services are performed. Patent Costs All patent-related costs in connection with filing and prosecuting patent applications are expensed to general and administrative expense as incurred, as recoverability of such expenditures is uncertain. Stock-Based Compensation The Company accounts for stock-based compensation arrangements with employees and non-employees for consultancy services in accordance with ASC 718, Stock Compensation The fair value is recognized over the period during which an optionee is required to provide services in exchange for the option award, known as the requisite service period (usually the vesting period) on a straight-line basis. For performance-based vesting, the fair value is also recognized on a straight-line basis over the requisite service period based on whether the performance conditions are probable. The Company reassesses the probability of achieving the performance conditions at each reporting date. Forfeitures are accounted for as they occur. Estimating the fair value of equity-settled awards as of the grant date using valuation models, such as the Black-Scholes option pricing model, is affected by assumptions regarding a number of complex variables. Changes in the assumptions can materially affect the fair value and ultimately how much stock-based compensation expense is recognized. These inputs are subjective and generally require analysis and judgment to develop. Expected Term—The expected term assumption represents the weighted average period that the stock-based awards are expected to be outstanding. The Company has elected to use the “simplified method” for estimating the expected term of the options, whereby the expected term equals the arithmetic average of the vesting term and the original contractual term of the option. Expected Volatility—For all stock options granted to date, the volatility data was estimated based on a study of publicly traded industry peer companies. For purposes of identifying these peer companies, the Company considered the industry, stage of development, size and financial leverage of potential comparable companies. Expected Dividend—The Black-Scholes valuation model calls for a single expected dividend yield as an input. The Company currently has no history or expectation of paying cash dividends on its common stock. Risk-Free Interest Rate—The risk-free interest rate is based on the yield available on U.S. Treasury zero-coupon issues similar in duration to the expected term of the equity-settled award. Prior to the Company’s IPO in May 2019, the estimated fair value of the common stock underlying the Company’s stock options was determined at each grant date by the Company’s board of directors, with input from management. All options to purchase shares of common stock were intended to be exercisable at a price per share not less than the per share fair value of the Company’s common stock underlying those options on the date of grant. In the absence of a public trading market for the Company’s common stock prior to the Company’s IPO in May 2019, on each grant date, the Company developed an estimate of the fair value of its common stock based on the information known to the Company on the date of grant, upon a review of any recent events and their potential impact on the estimated fair value per share of the common stock, and in part on input from an independent third-party valuation. As is provided for in Section 409A of the Internal Revenue Code of 1986, as amended (the “Code”), the Company generally relied on valuations for up to twelve months unless the Company had experienced a material event that would have affected the estimated fair value of its common stock. The valuations of the Company’s common stock performed prior to the Company’s IPO in May 2019, were determined in accordance with the guidelines outlined in the American Institute of Certified Public Accountants Practice Aid, Valuation of Privately-Held-Company Equity Securities Issued as Compensation (the “Practice Aid”). The methodology to determine the fair value of common stock included estimating the fair value of the enterprise using a market approach, which estimates the fair value of the Company by including an estimation of the value of the business based on guideline public companies under a number of different scenarios. The assumptions used to determine the estimated fair value of the Company’s common stock were based on numerous objective and subjective factors, combined with management judgment, including external market conditions affecting the pharmaceutical and biotechnology industry and trends within the industry; the Company’s stage of development; the rights, preferences and privileges of the Company’s convertible preferred stock relative to those of the Company’s common stock; the prices at which the Company sold shares of convertible preferred stock; the Company’s financial condition and operating results, including the Company’s levels of available capital resources; the progress of the Company’s research and development efforts, stage of development and business strategy; equity market conditions affecting comparable public companies; general U.S. market conditions; and the lack of marketability of the Company’s common stock. The Practice Aid identifies various available methods for allocating enterprise value across classes and series of capital stock to determine the estimated fair value of common stock at each valuation date. In accordance with the Practice Aid, the Company considered the following methods: • Option Pricing Method (“OPM”)—The OPM treats common stock and convertible preferred stock as call options on the total equity value of a company, with exercise prices based on the value thresholds at which the allocation among the various holders of a company’s securities changes. Under this method, the common stock has value only if the funds available for distribution to stockholders exceed the value of the liquidation preferences at the time of a liquidity event, such as a strategic sale or merger. The common stock is modeled as a call option on the underlying equity value at a predetermined exercise price. In the model, the exercise price is based on a comparison with the total equity value rather than, as in the case of a regular call option, a comparison with a per share stock price. Thus, common stock is considered to be a call option with a claim on the enterprise at an exercise price equal to the remaining value immediately after the convertible preferred stock liquidation preference is paid. The OPM uses the Black-Scholes option-pricing model to price the call options. This model defines the securities’ fair values as functions of the current fair value of a company and uses assumptions, such as the anticipated timing of a potential liquidity event and the estimated volatility of the equity securities. • Probability Weighted Expected Return Method (“PWERM”)—Under the PWERM methodology, the fair value of common stock is estimated based upon an analysis of future values for the company, assuming various outcomes. The common stock value is based on the probability-weighted present value of expected future investment returns considering each of the possible outcomes available as well as the rights of each class of stock. The future value of the common stock under each outcome is discounted back to the valuation date at an appropriate risk-adjusted discount rate and probability weighted to arrive at an indication of value for the common stock. • Hybrid Method—The hybrid method is a PWERM where the equity value in one of the scenarios is calculated using an OPM. In the hybrid method used by the Company, it considered an IPO as the other potential future liquidity event. The equity value for the IPO scenario was determined using the guideline public company (“GPC”), method under the market approach. The relative probability of the IPO scenario was determined based on an analysis of market conditions at the time and expectations as to the timing and likely prospects of the IPO at each valuation date. In application of the GPC method, the Company considered publicly traded companies in the biopharmaceutical industry that had a similar profile to the Company’s as well as recently completed IPOs as indicators of estimated future value in an IPO. The Company then discounted that future value back to the valuation date at an appropriate discount rate. In determining the estimated fair value of the Company’s common stock prior to Company’s IPO in May 2019, the board of directors considered the fact that the Company’s stockholders could not freely trade the Company’s common stock in the public markets. Accordingly, the Company’s board of directors applied discounts to reflect the lack of marketability of common stock based on the weighted-average expected time to liquidity. The estimated fair value of the Company’s common stock at each grant date reflected a non-marketability discount partially based on the anticipated likelihood and timing of a future liquidity event. Subsequent to the completion of the Company’s IPO in May 2019, the fair value of the Company’s common stock has been determined based on the closing price of the Company’s common stock as reported on the date of grant on the primary stock exchange on which the Company’s common stock is traded. Income Taxes The Company accounts for income taxes using the asset and liability method. Under this method, deferred tax assets and liabilities are determined based on differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. Deferred income tax assets are reduced, as necessary, by a valuation allowance when management determines it is more likely than not that some or all of the tax benefits will not be realized. The Company applies the provisions of ASC 740, Income Taxes (“ASC 740”), which prescribes a comprehensive model for how a company should recognize, measure, present, and disclose in its financial statements uncertain tax positions that the company has taken or expects to take on a tax return. These Condensed Consolidated Financial Statements reflect expected future tax consequences of such positions presuming the taxing authorities possess full knowledge of the position and all relevant facts. Leases Under ASC 842, the Company determines if an arrangement is a lease at its inception. If an operating lease has a term greater than one year, the lease is recognized in the balance sheet as a right-of-use asset and an operating lease liability at lease commencement. The Company elected the short-term lease practical expedient; therefore, if an operating lease has a term less than one year, the Company will not recognize the lease on its balance sheet. The operating right-of-use asset represents the Company’s right of use to an underlying asset for the term of the lease, and the operating liability represents the Company’s obligation to make lease payments arising from the lease. Operating lease right-of-use assets and operating lease liabilities are determined and recognized on the commencement date of the lease based on the present value of lease payments over the term of the lease. As the Company’s leases do not provide an implicit rate within the lease, the Company uses its incremental borrowing rate, which is updated periodically, based on information available at the commencement date of the lease to determine the present value of the lease payments. Basic and Diluted Net Loss per Common Share Basic and diluted net loss per common share outstanding is determined by dividing net loss by the weighted average common shares outstanding during the period. For all periods presented, shares issuable upon exercise of stock options have been excluded from the calculation because their effects would be anti-dilutive. Therefore, the weighted average common shares used to calculate both basic and diluted net loss per share are the same for each of the periods presented. Recently Adopted Accounting Pronouncements On January 1, 2021, the Company adopted ASU No. 2019-12- Income Taxes (Topic 740) Recently Issued Accounting Pronouncements There have been no new accounting pronouncements during the three months ended March 31, 2021, which could be expected to materially impact the Company’s unaudited Condensed Consolidated Financial Statements. |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 3 Months Ended |
Mar. 31, 2021 | |
Prepaid Expense And Other Assets Current [Abstract] | |
Prepaid Expenses and Other Current Assets | 3. Prepaid expenses and other current assets consisted of the following: March 31, 2021 December 31, 2020 Prepaid corporate insurance $ 174 $ 562 Prepaid R&D payments 170 333 Other 245 373 $ 589 $ 1,268 |
Leases
Leases | 3 Months Ended |
Mar. 31, 2021 | |
Leases [Abstract] | |
Leases | 4. Leases Effective March 1, 2013, the Company entered into a lease for office space in New Haven, CT and commencing March 1, 2018, the Company entered into the First Amendment to the lease. The leased space approximates 5,600 square feet and the lease has a term of 60 months. The lease requires monthly payments ranging from approximately $10 to $11 through February 1, 2023 and provides for two designated months of free rent. The incremental borrowing rate used on existing leases as of March 31, 2021 was 13.0%. The right-of-use asset also includes any lease payments related to initial direct costs and prepayments, and excludes lease incentives. Lease expense is recognized on a straight-line basis over the lease term. The Company had no new leases during the three months ended March 31, 2021. The Company’s operating leases consist of real estate and equipment, and have remaining terms of approximately 2 years March 31, 2021 December 31, 2020 Assets: Operating lease right-of-use asset $ 204 $ 227 Liabilities: Operating lease liabilities, current portion 107 113 Operating lease liabilities, long term portion 123 144 Total operating lease liabilities $ 230 $ 257 Future minimum lease payments under the operating leases were as follows: March 31, 2021 2021 $ 104 2022 131 2023 24 Total lease payments 259 Less: imputed discount rate (29 ) Carrying value of operating lease liabilities $ 230 Lease expense under operating leases, including leases of office equipment, was $30 and $34 for the three months ended March 31, 2021 and 2020, respectively. Lease payments made in the three months ended March 31, 2021 and 2020 were $34 and $45, respectively, with such amounts reflected in the Condensed Consolidated Statements of Cash Flows in operating activities. |
Accrued Expenses
Accrued Expenses | 3 Months Ended |
Mar. 31, 2021 | |
Payables And Accruals [Abstract] | |
Accrued Expenses | 5. Accrued Expenses Accrued expenses consisted of the following: March 31, 2021 December 31, 2020 Accrued R&D projects $ 2,606 $ 1,754 Accrued consulting and professional fees 662 560 Accrued compensation and benefits 471 954 Other 108 158 $ 3,847 $ 3,426 |
Debt
Debt | 3 Months Ended |
Mar. 31, 2021 | |
Debt Disclosure [Abstract] | |
Debt | 6. Debt Silicon Valley Bank Term Loan On August 13, 2020 (the “Effective Date”), the Company entered into a loan and security agreement (the “SVB Loan Agreement”) with Silicon Valley Bank, as lender (“SVB”), pursuant to which SVB provided a term loan to the Company in the original principal amount of $14.0 million (the “SVB Term Loan”). The Company may use the proceeds from the SVB Term Loan for working capital and general corporate purposes. The SVB Term Loan bears interest at a floating rate per annum equal to the greater of (A) the prime rate plus 1.00% and (B) 4.25%. If SVB receives evidence satisfactory to it that the Company has (i) received positive data for the Phase 2b/3 clinical trial of Haduvio sufficient to advance Haduvio into a second Phase 3 clinical trial for prurigo nodularis, and (ii) raised sufficient financing to fund such Phase 3 clinical trial and the Company’s operations, (together, the “Phase 3 Event”), the interest rate under the SVB Term Loan will be adjusted to a floating rate equal to the greater of (A) the prime rate plus 3.00% and (B) 6.25% (see term loan derivative liability discussion below). On the first business day of each month, the Company will be required to make monthly interest payments and commencing on March 1, 2022, the Company will be required to repay the SVB Term Loan in 24 consecutive installments of principal plus monthly payments of accrued interest. All outstanding principal and accrued and unpaid interest under the SVB Term Loan and all other outstanding obligations with respect to the SVB Term Loan are due and payable in full on February 1, 2024. The SVB Loan Agreement permits voluntary prepayment of all, but not less than all, of the SVB Term Loan, subject to a prepayment premium. Such prepayment premium would be 3.00% of the principal amount of the SVB Term Loan if prepaid prior to the first anniversary of the Effective Date, 2.00% of the principal amount of the SVB Term Loan if prepaid on or after the first anniversary of the Effective Date but prior to the second anniversary of the Effective Date, and 1.00% of the principal amount of the SVB Term Loan if prepaid on or after the second anniversary of the Effective Date but prior to February 1, 2024. Upon repayment in full of the SVB Term Loan, the Company will be required to pay a final payment fee equal to $1.2 million. The SVB Term Loan and related obligations under the SVB Loan Agreement are secured by substantially all of the Company’s properties, rights and assets, except for its intellectual property (which is subject to a negative pledge under the SVB Loan Agreement). If the Company fails to meet certain equity raise requirements under the SVB Loan Agreement, including raising $12.0 million by June 30, 2021, the Company will be required to deposit unrestricted and unencumbered cash equal to 100% of the principal amount of the SVB Term Loan then outstanding in a cash collateral account with SVB, which can be used by SVB to prepay the SVB Term Loan at any time. The SVB Loan Agreement contains customary representations, warranties, events of default and covenants. The occurrence and continuation of an event of default could cause interest to be charged at the rate that is otherwise applicable plus 5.00% (unless SVB elects to impose a smaller increase) and would provide SVB with the right to accelerate all obligations under the SVB Loan Agreement, and exercise remedies against the Company and the collateral securing the SVB Term Loan and other obligations under the SVB Loan Agreement, including foreclosure against assets securing the SVB Term Loan and other obligations under the SVB Loan Agreement, including the Company’s cash. In August 2020, in connection with the SVB Term Loan, the Company paid $57 in financing costs to a third party, which were recorded as deferred charges—loan and will be amortized over the life of the SVB Term Loan using the effective interest method. Amortization of these deferred financing charges totaled $6 for the three months ended March 31, 2021 and is included in interest expense in the Company’s Condensed Consolidated Statements of Operations. Loan discount—unamortized deferred charges totaled $42 and $48 at March 31, 2021 and December 31, 2020, respectively, and is included as a direct reduction of the carrying value of the term loan payable on the Company’s Condensed Consolidated Balance Sheets. In August 2020, in connection with the execution of the SVB Loan Agreement, the Company paid $27 in financing costs to SVB, which were recorded as loan discounts. These loan discounts are included as a reduction in the balance of the term loan payable on the Company’s Condensed Consolidated Balance Sheets and will be accreted over the life of the SVB Term Loan using the effective interest method. Accretion of these loan discounts totaled $3 for the three months ended March 31, 2021, and is included in interest expense in the Company’s Condensed Consolidated Statements of Operations. At March 31, 2021 and December 31, 2020, the loan discount-financing costs balance was $20 and $23, respectively. In connection with the SVB Loan Agreement, the Company is obligated to pay a final payment fee of $1.2 million upon repayment in full of the SVB Term Loan. The final payment fee is being accrued over the life of the SVB Term Loan using the effective interest method and is included as an increase in the balance of the term loan payable on the Company’s Condensed Consolidated Balance Sheets. At March 31, 2021 and December 31, 2020, $301 and $183 was accrued for the final payment fee, respectively. Upon the occurrence of the Phase 3 Event, the interest rate on the SVB Term Loan will increase by 2.00% (the “Contingent Interest Rate Increase”) as described above. The Contingent Interest Rate Increase represents a free-standing financial instrument. Accordingly, the Company accounted for the Contingent Interest Rate Increase as a derivative under ASC 815, Derivatives and Hedging, and therefore, recorded a term loan derivative liability for the Contingent Interest Rate Increase at its fair value of $187 on the Effective Date of the SVB Loan Agreement. The Company adjusts this liability to fair value at each reporting date it remains outstanding, with such adjustments recorded as non-cash charges in other (expense) income, net in the Company’s Condensed Consolidated Statements of Operations. The total fair value of this liability was determined to be $202 and $196 at March 31, 2021 and December 31, 2020, respectively. The change in fair value of the term loan derivative liability as of March 31, 2021 as compared to the fair value at its last measurement at December 31, 2020 date was $6. The term loan derivative liability is presented as a non-current liability on the Company’s Condensed Consolidated Balance Sheets as of March 31, 2021 and December 31, 2020. Upon recording such term loan derivative liability, the Company also recorded an offsetting term loan discount – interest, to be amortized to interest expense in the Company’s Condensed Consolidated Statements of Operations through the SVB Term Loan’s maturity date using the effective interest method. Such amortization was $18 in the three months ended March 31, 2021. At March 31, 2021 and December 31, 2020, the balance of the term loan discount – interest was $140 and $158, respectively, and is included as a reduction in the balance of the term loan payable on the Company’s Condensed Consolidated Balance Sheets. Fair values of the term loan derivative liability are estimated utilizing a probability-weighted cash flow approach, including variables for the timing of the Phase 3 Event and other probability estimates. For the fair value calculations of the term loan derivative liability at March 31, 2021 and December 31, 2020, significant inputs included the Contingent Interest Rate Increase of 2.00%, a discount rate of 12.0%; and the SVB Term Loan maturity date of February 1, 2024. For the three-month period ended March 31, 2021, interest expense under the SVB Term Loan totaled $294, which includes amortization of deferred financing charges, accretion of loan discount-financing costs, accrual of the final payment fee, amortization of the term loan discount-interest and the stated interest on the SVB Term Loan, all as described above. There was no such interest expense on the SVB Term Loan for the three-month period ended March 31, 2020. As of March 31, 2021 the Company had outstanding borrowings of $14.0 million under the SVB Term Loan and the term loan payable balance as presented on the Company’s Condensed Consolidated Balance Sheets as of March 31, 2021 and December 31, 2020 was comprised as shown below. March 31, December 31, 2021 2020 Principal outstanding under term loan $ 14,000 $ 14,000 Term loan discount-interest (140 ) (158 ) Term loan discount-unamortized deferred charges (42 ) (48 ) Term loan discount-financing costs, net of accretion (20 ) (23 ) Term loan-final payment fee 301 183 14,099 13,954 Less current portion 583 — Term loan payable, non-current $ 13,516 $ 13,954 Interest expense on the SVB Term Loan, which is comprised of interest payments, accretion and amortization of term loan discounts and the accrual of the final payment fee, is shown below for the three months ended March 31, 2021. There was no such expense under the SVB Term Loan for the three months ended March 31, 2020. Three months ended March 31, 2021 Interest payments $ 149 Accretion and amortization of term loan discounts 27 Accrual of the final payment fee 118 $ 294 |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2021 | |
Stockholders Equity Note [Abstract] | |
Stockholders' Equity | 7. Preferred Stock As of March 31, 2021 and December 31, 2020, the Company’s restated certificate of incorporation authorized the Company to issue 5,000,000 shares of preferred stock. Common Stock As of March 31, 2021 and December 31, 2020, the Company’s restated certificate of incorporation authorized the Company to issue 200,000,000 shares of common stock with a par value of $0.001 per share. As of March 31, 2021 and December 31, 2020, the Company had reserved 4,573,538 March 31, 2021 December 31, 2020 Shares of common stock reserved for future issuance under the 2012 Stock Incentive Plan 921,824 921,824 Shares of common stock reserved for future issuance under the 2019 Stock Incentive Plan 3,138,793 2,396,922 Shares of common stock reserved for future issuance under the 2019 Employee Stock Purchase Plan 512,921 327,454 4,573,538 3,646,200 At-the-Market Offering In June 2020, the Company entered into the ATM Sales Agreement, under which the Company may issue and sell shares of its common stock, from time to time, having an aggregate offering price of up to $12.0 million. Sales of common stock under the ATM Sales Agreement may be made by any method that is deemed an “at the market” offering as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended. The Company is not obligated to make any sales of its common stock under the ATM Sales Agreement. The Company began making sales pursuant to the ATM Sales Agreement in July 2020. During the three months ended March 31, 2021, the Company issued and sold an aggregate of 1,367,621 shares of common stock for gross proceeds of $4.4 million, before deducting estimated commissions and allocated fees of $0.3 million. As of March 31, 2021 the Company had issued and sold an aggregate of 2,055,497 shares of common stock for gross proceeds of $7.6 million, before deducting estimated commissions and allocated fees of $0.5 million. Stock-Based Awards In April 2019, the Company’s board of directors adopted the 2019 Stock Incentive Plan (the “2019 Plan”), which became effective on May 7, 2019. The 2019 Plan provides for the grant of incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock awards, restricted stock units and other stock-based awards. The Company’s employees, officers, directors, consultants and advisors are eligible to receive awards under the 2019 Plan. The 2019 Plan is administered by the Company’s board of directors. The total number of shares of common stock that may be issued under the 2019 Plan and the 2012 Plan was 4,060,617 as of March 31, 2021, of which 815,416 shares remained available for grant under the 2019 Plan. As of March 31, 2021, awards may be made under the 2019 Plan for up to such number of shares of the Company’s common stock as is equal to the sum of i) 1,578,947 shares; plus ii) the number of shares (up to 1,157,894 shares) equal to the number of shares of the Company’s common stock subject to outstanding awards under the 2012 Stock Incentive Plan (the “2012 Plan”) that expire, terminate or are otherwise cancelled, forfeited or repurchased by the Company at their original issuance price pursuant to a contractual repurchase right; plus iii) an annual increase to be added on the first day of each fiscal year, beginning with 2020 and continuing through 2029, equal to the least of (a) 2,105,623 shares of common stock, (b) 4% of the number of outstanding shares of the Company’s common stock on such date, and (c) an amount determined by the Company’s board of directors. . The 2012 Plan was adopted by the Company’s board of directors and stockholders. The 2012 Plan provides for the issuance of stock-based awards to the Company’s employees, officers, directors, consultants and advisors. The Company’s board of directors administers the 2012 Plan. Options granted under the 2019 Plan and the 2012 Plan have a maximum term of ten years. Options granted to employees, officers and non-employees generally vest over four years based on varying vesting schedules that primarily include: 25% vesting on the first anniversary date of grant and the balance ratably over the next 36 months or vesting in equal monthly or quarterly installments over four ye ars. 1,249,653 shares of common stock were granted and outstanding, net of cancelations, under the 2019 Plan. As of March 31, 2021 and December 31, 2020, options to purchase 921,824 shares of common stock were granted and outstanding, net of cancelations, under the 2012 Plan. In April 2019, the Company’s board of directors adopted a resolution effective on May 7, 2019 that no further stock options or other equity-based awards may be granted under the 2012 Plan. In February 2021, the compensation committee of the Company’s board of directors approved the grant of stock options with performance-based vesting (“PSOs”) to employees of the Company. The PSOs granted in February 2021 vest based on the timing and successful results of the Company’s PRISM or CANAL clinical trials. A summary of the Company’s combined stock option activity for the 2019 Plan and the 2012 Plan for the three months ended March 31, 2021 is as follows: Number of Option Shares Weighted Average Exercise Price Outstanding as of December 31, 2020 2,171,477 $ 5.62 Granted 1,074,875 $ 3.18 Forfeited — $ - Expired (1,151 ) $ 10.00 Exercised — $ - Outstanding as of March 31, 2021 3,245,201 $ 4.81 Options exercisable as of March 31, 2021 1,189,551 $ 4.87 Options unvested as of March 31, 2021 2,055,650 $ 4.77 In April 2019, the Company’s board of directors adopted the 2019 Employee Stock Purchase Plan (the “2019 ESPP”), which became effective on May 7, 2019. The 2019 ESPP is administered by the Company’s board of directors. The total number of shares of common stock that may be issued under the 2019 ESPP Plan was 518,918 All of the Company’s employees are eligible to participate in the 2019 ESPP, provided that: • such person is customarily employed by the Company for more than 20 hours a week and for more than five months in a calendar year; • such person has been employed by the Company for at least three months prior to enrolling in the 2019 ESPP; and • such person was an employee of the Company on the first day of the applicable offering period under the 2019 ESPP. The following table summarizes the classifications of stock-based compensation expenses for the 2012 Plan, the 2019 Plan and the 2019 ESPP recognized in the Condensed Consolidated Statements of Operations: Three Months Ended March 31, 2021 2020 Research and development expense $ 173 $ 93 General and administrative expense 545 637 $ 718 $ 730 |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 8. During the three months ended March 31, 2021 and 2020, the Company maintained a full valuation allowance on deferred tax assets. Therefore, the Company has not recorded a provision for income taxes. |
Net Loss per Share
Net Loss per Share | 3 Months Ended |
Mar. 31, 2021 | |
Earnings Per Share [Abstract] | |
Earnings Per Share | 9 . The following table summarizes the computation of basic and diluted net loss per share attributable to common stockholders of the Company: Three Months Ended March 31, 2021 2020 Net loss $ (8,371 ) $ (8,473 ) Weighted average common shares used in net loss per share attributable to common stockholders, basic and diluted 19,417,038 17,834,570 Basic and diluted net loss per common share outstanding $ (0.43 ) $ (0.48 ) The Company’s potential dilutive securities, which include stock options, have been excluded from the computation of diluted net loss per share attributable to common stockholders whenever the effect of including them would be to reduce the net loss per share. In periods where there is a net loss, the weighted average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same. The common shares underlying stock options, based on stock options outstanding as of March 31, 2021 and 2020, were excluded from the calculation of diluted net loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect. |
Collaborative and Licensing Agr
Collaborative and Licensing Agreements | 3 Months Ended |
Mar. 31, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Collaborative and Licensing Agreements | 10 . The Company enters into collaborative and licensing agreements with pharmaceutical companies to in-license, develop, manufacture and/or market products that fit within its business strategy. Endo Pharmaceuticals Inc. In May 2011, the Company entered into an agreement with Penwest Pharmaceuticals Co. (“Penwest”) (subsequently merged into its parent, Endo Pharmaceuticals Inc. (“Endo”)) for an exclusive worldwide sublicensable license under certain patent rights and know-how controlled by Penwest to develop and commercialize products incorporating nalbuphine hydrochloride in any formulation, including an extended release formulation such as Haduvio, in all fields and for any use. Under the license agreement, the Company paid Penwest a non-creditable, non-refundable upfront license fee of $25. The Company may also become obligated to make milestone payments to Endo of $250, which would become due upon the successful completion of the first Phase 3 clinical trial of a licensed product candidate, such as the Phase 2b/3 PRISM trial, and $750, which would become due upon the marketing approval of a licensed product in the United States, and to pay mid-single-digit royalties based on net sales of the licensed products by the Company, its affiliates and sublicensees. In addition, the Company is obligated to pay Endo a low-to-mid double-digit percentage of certain income it receives from sublicensees, based on the date of the definitive agreement under which the sublicense was granted. The Company’s royalty obligation with respect to each licensed product in each country commences upon the first commercial sale of the product in that country and extends until the later of the expiration, unenforceability or invalidation of the last valid claim of any licensed patent or application covering the licensed product in the country or the expiration of 10 years after the first commercial sale of the licensed product in the country, which period is referred to as the royalty term. Upon the expiration of the royalty term for a product in a country, the Company is thereafter obligated to pay a low single-digit know-how and trademark royalty. Under the agreement, the Company has granted Endo a non-exclusive, royalty-free (except for pass-through payments to third parties), sublicensable license under its relevant patent rights, to use any improvement the Company makes to Endo’s controlled release technology, for any product other than the products under which it is licensed by Endo. Both the Company and Endo have the right to terminate the agreement if the other party materially breaches the agreement and fails to cure the breach within specified cure periods. Endo also has the right to terminate in the event the Company undergoes specified bankruptcy, insolvency or liquidation events, and the Company has the right to terminate the agreement at its convenience at any time on 180 days’ notice to Endo. Additionally, if the Company or any of the Company’s sublicensees challenge the validity or enforceability of any licensed patent rights covering a licensed product, and that challenge is not terminated within a specified period, the agreement will immediately terminate and all licenses granted under the agreement shall be revoked. Upon termination of the agreement, the Company must transfer to Endo all regulatory filings and approvals relating to the development, manufacture or commercialization of the licensed products and all trademarks, other than the Company’s corporate trademarks, then being used in connection with the licensed products. If the agreement is terminated under certain specified circumstances, the Company will be deemed to have granted Endo a perpetual, royalty-free (except for pass-through payments to third parties), worldwide, exclusive, sublicensable license, under any improvements the Company made to the licensed know-how, and any related patent rights the Company has, to manufacture and commercialize the licensed products. Exclusive License Agreement with Rutgers In November 2018, the Company entered into an agreement with Rutgers, The State University of New Jersey (“Rutgers”) for an exclusive, worldwide, sublicensable license under certain patent rights controlled by Rutgers and for a non-exclusive, worldwide, sublicensable license under certain know-how controlled by Rutgers, in each case to develop and commercialize products incorporating nalbuphine for any human or animal use. Upon entering into the license agreement, the Company paid Rutgers a minimal upfront license issue fee, which was recorded as R&D expense in 2018, and agreed to pay Rutgers a minimal annual license fee. The Company may become obligated to make milestone payments to Rutgers in the aggregate of up to $331 based on the achievement of certain clinical, regulatory and sales milestones. The Company has also agreed to pay Rutgers a low single-digit percentage of certain income it receives from sublicensees and to pay tiered low single-digit royalties based on net sales of licensed products by the Company and its affiliates and sublicensees. The Company’s royalty obligation with respect to each licensed product in each country commences on the date of the first commercial sale of the licensed product in that country following receipt of marketing approval and extends until the later of the date of expiration, unenforceability or invalidation of the last valid claim of any licensed patent or patent application covering the licensed product in the country and 10 years after the first commercial sale of the first licensed product sold anywhere in the world, which period is referred to as the royalty term. Upon the expiration of the royalty term for a licensed product in a country, the license granted to the Company under the agreement shall become perpetual, fully paid-up, irrevocable and royalty-free in such country. The royalty is subject to reduction in certain circumstances. Restructuring Agreement with MentiNova, LLC In November 2018, concurrent with the signing of the agreement with Rutgers described above, the Company entered into a restructuring agreement with MentiNova, LLC (“MentiNova”) for the purchase of specified information and know-how, specified contractual rights and benefits, and all books and records of MentiNova related thereto (collectively, the “Acquired Assets”). Upon entering into the license agreement, the Company paid MentiNova an aggregate upfront payment of $119, which was recorded as R&D expense in 2018, subject to specified closing adjustments. The Company may become obligated to make milestone payments to MentiNova in the aggregate of up to $1.2 million based on the achievement of certain clinical and regulatory milestones as well as tiered low single-digit royalties based on net sales of products containing nalbuphine as the sole active pharmaceutical ingredient that are developed by the Company using the Acquired Assets or the intellectual property licensed to the Company under the Rutgers agreement described above (the “Rutgers IP”) for indications that are within the scope of the Rutgers IP. The royalty is subject to reduction in certain circumstances. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 1 1 . Commitments and Contingencies A significant portion of the Company’s development activities are outsourced to third parties under agreements, including with clinical research organizations, and contract manufacturers in connection with the production of clinical trial materials. These arrangements may require the Company to pay termination costs to the third parties for reimbursement of costs and expenses incurred in the event of the orderly termination of contractual services. The Company also has commitments under lease and licensing agreements (Note 4 and Note 10). |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited interim Condensed Consolidated Financial Statements for the three months ended March 31, 2021 and 2020 included herein, have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim information. Certain prior year balances have been reclassified to conform to the current year presentation. Such reclassifications did not affect loss from operations or net loss. Certain information and footnote disclosures typically prepared in accordance with GAAP have been condensed or omitted pursuant to SEC rules and regulations. The accompanying unaudited Condensed Consolidated Financial Statements and notes should be read in conjunction with the audited consolidated financial statements and related notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 (the “Annual Report on Form 10-K”). The accompanying Condensed Consolidated Financial Statements include the accounts of Trevi Therapeutics, Inc. and its wholly-owned subsidiary Trevi Therapeutics Limited. Intercompany balances and transactions have been eliminated. All amounts presented are in thousands of dollars, except share and per share amounts, unless noted otherwise. The Company has evaluated events occurring subsequent to March 31, 2021 for potential recognition or disclosure in the Condensed Consolidated Financial Statements and concluded there were no subsequent events that required recognition or disclosure. |
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 at the date of the financial statements and the reported amounts of the expenses during the reporting periods. Significant estimates and assumptions reflected in these Condensed Consolidated Financial Statements include, but are not limited to, the recognition of research and development (“R&D”) expenses, the valuation of stock-based awards and the valuation allowance of deferred tax assets resulting from net operating losses. In addition, management’s assessment of the Company’s ability to continue as a going concern involves the estimation of the amount and timing of future cash inflows and outflows. On an ongoing basis, management evaluates its estimates in light of changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates. The inputs into the Company’s estimates also considered the economic implications of COVID-19 on the Company’s estimates. |
Unaudited Interim Financial Information | Unaudited Interim Financial Information The accompanying interim Condensed Consolidated Balance Sheet as of March 31, 2021 and the Condensed Consolidated Statements of Operations, the Condensed Consolidated Statements of Stockholders’ Equity and the Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2021 and 2020 are unaudited. The unaudited interim Condensed Consolidated Financial Statements have been prepared on the same basis as the audited annual consolidated financial statements and, in the Company’s opinion, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statements of its financial position as of March 31, 2021 and the results of its operations and its cash flows for the three months ended March 31, 2021 and 2020. The results for the three months ended March 31, 2021 and 2020 are not necessarily indicative of results to be expected for the year ending December 31, 2021, or any other interim period, or any future year or period. |
Cash Equivalents | Cash Equivalents The Company classifies short-term, highly liquid investments with an original term of three months or less at the date of purchase as cash equivalents. |
Fair Value Measurements | Fair Value Measurements The Company’s financial instruments have consisted of cash and cash equivalents, other current assets, accounts payable, accrued expenses, term loans and term loan derivative liability (Note 6). Fair instruments. The term loan derivative liability is recorded at fair value, which is estimated utilizing a probability-weighted cash flow approach (Note 6). Current accounting guidance defines fair value, establishes a framework for measuring fair value in accordance with Accounting Standards Codification (“ASC”) 820, Fair Value Measurements and Disclosures Level 1—Observable inputs—quoted prices in active markets for identical assets and liabilities. Level 2—Observable inputs other than the quoted prices in active markets for identical assets and liabilities—such as quoted prices for similar instruments, quoted prices for identical or similar instruments in inactive markets, or other inputs that are observable or can be corroborated by observable market data. Level 3—Unobservable inputs—includes amounts derived from valuation models where one or more significant inputs are unobservable and require the company to develop relevant assumptions. The following table summarizes the financial assets and financial liabilities measured at fair value on a recurring basis and the basis for that measurement, by level within the fair value hierarchy (Note 6): Level 1 Level 2 Level 3 March 31, 2021 Financial assets carried at fair value: Money market funds (1) $ 40,772 $ — $ — Financial liabilities carried at fair value: Term loan derivative liability $ — $ — $ 202 December 31, 2020 Financial assets carried at fair value: Money market funds (1) $ 44,095 $ — $ — Financial liabilities carried at fair value: Term loan derivative liability $ — $ — $ 196 (1) The following table represents a roll-forward of the fair value of Level 3 instruments (significant unobservable inputs): March 31, December 31, 2021 2020 Financial liabilities Balance at beginning of year $ 196 $ 187 Change in fair value of term loan derivative liability 6 9 Ending balance $ 202 $ 196 |
Property, Equipment and Leasehold Improvements | Property, Equipment and Leasehold Improvements Property, equipment and leasehold improvements (consisting of furniture, computer and office equipment and leasehold improvements) are stated at cost, net of accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the respective assets (three years for computer equipment, five years for furniture and office equipment, and the shorter of the term of the lease or useful life for leasehold improvements). |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets ASC 360, Property, Plant, and Equipment, |
Foreign Currency Transactions | Foreign Currency Transactions The Company, at times, contracts with vendors and consultants outside of the United States, resulting in liabilities denominated in foreign currency. The transactions are recorded in U.S. dollars on the transaction dates and any currency fluctuation through the payment date is recorded as currency gains or losses in the Condensed Consolidated Statements of Operations. |
Deferred Offering Costs | Deferred Offering Costs The Company capitalizes certain legal, professional, accounting and other third-party fees that are directly associated with in-process equity financings as deferred offering costs until such financings are consummated. After consummation of an equity financing, these costs are recorded in stockholders’ equity as a reduction of additional paid-in capital generated as a result of the offering. Should the planned equity financing no longer be considered probable of being consummated, the deferred offering costs are expensed immediately as a charge to operating expenses. Deferred offering costs relating to the Company’s ATM Sales Agreement were $162 |
Research and Development Expenses | Research and Development Expenses All of the Company’s research and development expenses consist of expenses incurred in connection with the development of Haduvio. These expenses include certain payroll and personnel expenses, including stock-based compensation, consulting costs, contract manufacturing costs and fees paid to clinical research organizations (“CROs”) to conduct certain research and development activities on the Company’s behalf. The Company does not allocate its costs by each indication for which it is developing Haduvio, as a significant amount of the Company’s development activities broadly support all indications. In addition, several of the Company’s departments support the Company’s Haduvio drug candidate development program and the Company does not identify internal costs for each potential indication. The Company expenses both internal and external research and development expenses as they are incurred. |
Accrued Research and Development Expenses | Accrued Research and Development Expenses The Company has entered into agreements with CROs, contract manufacturing organizations (“CMOs”) and other companies that provide services in connection with the Company’s research and development activities. The Company’s research and development accruals are estimated based on the level of services performed, progress of the studies, including the phase or completion of events, and contracted costs. The estimated costs of research and development provided, but not yet invoiced, are included in accrued expenses on the Condensed Consolidated Balance Sheets. If the actual timing of the performance of services or the level of effort varies from the original estimates, the Company will adjust the accrual accordingly. Payments made to CROs, CMOs and other companies under these arrangements in advance of the performance of the related services are recorded as prepaid expenses or as non-current deposits, as applicable, and are recognized as expenses as the goods are delivered or the related services are performed. |
Patent Costs | Patent Costs All patent-related costs in connection with filing and prosecuting patent applications are expensed to general and administrative expense as incurred, as recoverability of such expenditures is uncertain. |
Stock-Based Compensation | Stock-Based Compensation The Company accounts for stock-based compensation arrangements with employees and non-employees for consultancy services in accordance with ASC 718, Stock Compensation The fair value is recognized over the period during which an optionee is required to provide services in exchange for the option award, known as the requisite service period (usually the vesting period) on a straight-line basis. For performance-based vesting, the fair value is also recognized on a straight-line basis over the requisite service period based on whether the performance conditions are probable. The Company reassesses the probability of achieving the performance conditions at each reporting date. Forfeitures are accounted for as they occur. Estimating the fair value of equity-settled awards as of the grant date using valuation models, such as the Black-Scholes option pricing model, is affected by assumptions regarding a number of complex variables. Changes in the assumptions can materially affect the fair value and ultimately how much stock-based compensation expense is recognized. These inputs are subjective and generally require analysis and judgment to develop. Expected Term—The expected term assumption represents the weighted average period that the stock-based awards are expected to be outstanding. The Company has elected to use the “simplified method” for estimating the expected term of the options, whereby the expected term equals the arithmetic average of the vesting term and the original contractual term of the option. Expected Volatility—For all stock options granted to date, the volatility data was estimated based on a study of publicly traded industry peer companies. For purposes of identifying these peer companies, the Company considered the industry, stage of development, size and financial leverage of potential comparable companies. Expected Dividend—The Black-Scholes valuation model calls for a single expected dividend yield as an input. The Company currently has no history or expectation of paying cash dividends on its common stock. Risk-Free Interest Rate—The risk-free interest rate is based on the yield available on U.S. Treasury zero-coupon issues similar in duration to the expected term of the equity-settled award. Prior to the Company’s IPO in May 2019, the estimated fair value of the common stock underlying the Company’s stock options was determined at each grant date by the Company’s board of directors, with input from management. All options to purchase shares of common stock were intended to be exercisable at a price per share not less than the per share fair value of the Company’s common stock underlying those options on the date of grant. In the absence of a public trading market for the Company’s common stock prior to the Company’s IPO in May 2019, on each grant date, the Company developed an estimate of the fair value of its common stock based on the information known to the Company on the date of grant, upon a review of any recent events and their potential impact on the estimated fair value per share of the common stock, and in part on input from an independent third-party valuation. As is provided for in Section 409A of the Internal Revenue Code of 1986, as amended (the “Code”), the Company generally relied on valuations for up to twelve months unless the Company had experienced a material event that would have affected the estimated fair value of its common stock. The valuations of the Company’s common stock performed prior to the Company’s IPO in May 2019, were determined in accordance with the guidelines outlined in the American Institute of Certified Public Accountants Practice Aid, Valuation of Privately-Held-Company Equity Securities Issued as Compensation (the “Practice Aid”). The methodology to determine the fair value of common stock included estimating the fair value of the enterprise using a market approach, which estimates the fair value of the Company by including an estimation of the value of the business based on guideline public companies under a number of different scenarios. The assumptions used to determine the estimated fair value of the Company’s common stock were based on numerous objective and subjective factors, combined with management judgment, including external market conditions affecting the pharmaceutical and biotechnology industry and trends within the industry; the Company’s stage of development; the rights, preferences and privileges of the Company’s convertible preferred stock relative to those of the Company’s common stock; the prices at which the Company sold shares of convertible preferred stock; the Company’s financial condition and operating results, including the Company’s levels of available capital resources; the progress of the Company’s research and development efforts, stage of development and business strategy; equity market conditions affecting comparable public companies; general U.S. market conditions; and the lack of marketability of the Company’s common stock. The Practice Aid identifies various available methods for allocating enterprise value across classes and series of capital stock to determine the estimated fair value of common stock at each valuation date. In accordance with the Practice Aid, the Company considered the following methods: • Option Pricing Method (“OPM”)—The OPM treats common stock and convertible preferred stock as call options on the total equity value of a company, with exercise prices based on the value thresholds at which the allocation among the various holders of a company’s securities changes. Under this method, the common stock has value only if the funds available for distribution to stockholders exceed the value of the liquidation preferences at the time of a liquidity event, such as a strategic sale or merger. The common stock is modeled as a call option on the underlying equity value at a predetermined exercise price. In the model, the exercise price is based on a comparison with the total equity value rather than, as in the case of a regular call option, a comparison with a per share stock price. Thus, common stock is considered to be a call option with a claim on the enterprise at an exercise price equal to the remaining value immediately after the convertible preferred stock liquidation preference is paid. The OPM uses the Black-Scholes option-pricing model to price the call options. This model defines the securities’ fair values as functions of the current fair value of a company and uses assumptions, such as the anticipated timing of a potential liquidity event and the estimated volatility of the equity securities. • Probability Weighted Expected Return Method (“PWERM”)—Under the PWERM methodology, the fair value of common stock is estimated based upon an analysis of future values for the company, assuming various outcomes. The common stock value is based on the probability-weighted present value of expected future investment returns considering each of the possible outcomes available as well as the rights of each class of stock. The future value of the common stock under each outcome is discounted back to the valuation date at an appropriate risk-adjusted discount rate and probability weighted to arrive at an indication of value for the common stock. • Hybrid Method—The hybrid method is a PWERM where the equity value in one of the scenarios is calculated using an OPM. In the hybrid method used by the Company, it considered an IPO as the other potential future liquidity event. The equity value for the IPO scenario was determined using the guideline public company (“GPC”), method under the market approach. The relative probability of the IPO scenario was determined based on an analysis of market conditions at the time and expectations as to the timing and likely prospects of the IPO at each valuation date. In application of the GPC method, the Company considered publicly traded companies in the biopharmaceutical industry that had a similar profile to the Company’s as well as recently completed IPOs as indicators of estimated future value in an IPO. The Company then discounted that future value back to the valuation date at an appropriate discount rate. In determining the estimated fair value of the Company’s common stock prior to Company’s IPO in May 2019, the board of directors considered the fact that the Company’s stockholders could not freely trade the Company’s common stock in the public markets. Accordingly, the Company’s board of directors applied discounts to reflect the lack of marketability of common stock based on the weighted-average expected time to liquidity. The estimated fair value of the Company’s common stock at each grant date reflected a non-marketability discount partially based on the anticipated likelihood and timing of a future liquidity event. Subsequent to the completion of the Company’s IPO in May 2019, the fair value of the Company’s common stock has been determined based on the closing price of the Company’s common stock as reported on the date of grant on the primary stock exchange on which the Company’s common stock is traded. |
Income Taxes | Income Taxes The Company accounts for income taxes using the asset and liability method. Under this method, deferred tax assets and liabilities are determined based on differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. Deferred income tax assets are reduced, as necessary, by a valuation allowance when management determines it is more likely than not that some or all of the tax benefits will not be realized. The Company applies the provisions of ASC 740, Income Taxes (“ASC 740”), which prescribes a comprehensive model for how a company should recognize, measure, present, and disclose in its financial statements uncertain tax positions that the company has taken or expects to take on a tax return. These Condensed Consolidated Financial Statements reflect expected future tax consequences of such positions presuming the taxing authorities possess full knowledge of the position and all relevant facts. |
Leases | Leases Under ASC 842, the Company determines if an arrangement is a lease at its inception. If an operating lease has a term greater than one year, the lease is recognized in the balance sheet as a right-of-use asset and an operating lease liability at lease commencement. The Company elected the short-term lease practical expedient; therefore, if an operating lease has a term less than one year, the Company will not recognize the lease on its balance sheet. The operating right-of-use asset represents the Company’s right of use to an underlying asset for the term of the lease, and the operating liability represents the Company’s obligation to make lease payments arising from the lease. Operating lease right-of-use assets and operating lease liabilities are determined and recognized on the commencement date of the lease based on the present value of lease payments over the term of the lease. As the Company’s leases do not provide an implicit rate within the lease, the Company uses its incremental borrowing rate, which is updated periodically, based on information available at the commencement date of the lease to determine the present value of the lease payments. |
Basic and Diluted Net Income (Loss) per Common Share | Basic and Diluted Net Loss per Common Share Basic and diluted net loss per common share outstanding is determined by dividing net loss by the weighted average common shares outstanding during the period. For all periods presented, shares issuable upon exercise of stock options have been excluded from the calculation because their effects would be anti-dilutive. Therefore, the weighted average common shares used to calculate both basic and diluted net loss per share are the same for each of the periods presented. |
Recently Adopted and Issued Accounting Pronouncements | Recently Adopted Accounting Pronouncements On January 1, 2021, the Company adopted ASU No. 2019-12- Income Taxes (Topic 740) Recently Issued Accounting Pronouncements There have been no new accounting pronouncements during the three months ended March 31, 2021, which could be expected to materially impact the Company’s unaudited Condensed Consolidated Financial Statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
Schedule of Financial Assets and Financial Liabilities Measured at Fair Value on Recurring Basis | The following table summarizes the financial assets and financial liabilities measured at fair value on a recurring basis and the basis for that measurement, by level within the fair value hierarchy (Note 6): Level 1 Level 2 Level 3 March 31, 2021 Financial assets carried at fair value: Money market funds (1) $ 40,772 $ — $ — Financial liabilities carried at fair value: Term loan derivative liability $ — $ — $ 202 December 31, 2020 Financial assets carried at fair value: Money market funds (1) $ 44,095 $ — $ — Financial liabilities carried at fair value: Term loan derivative liability $ — $ — $ 196 (1) |
Schedule of Fair Value, Financial Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation | The following table represents a roll-forward of the fair value of Level 3 instruments (significant unobservable inputs): March 31, December 31, 2021 2020 Financial liabilities Balance at beginning of year $ 196 $ 187 Change in fair value of term loan derivative liability 6 9 Ending balance $ 202 $ 196 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Prepaid Expense And Other Assets Current [Abstract] | |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consisted of the following: March 31, 2021 December 31, 2020 Prepaid corporate insurance $ 174 $ 562 Prepaid R&D payments 170 333 Other 245 373 $ 589 $ 1,268 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Leases [Abstract] | |
Schedule of Balance Sheet Information Related to Operating Leases | The following table summarizes the Company’s operating leases as presented on its Condensed Consolidated Balance Sheets: March 31, 2021 December 31, 2020 Assets: Operating lease right-of-use asset $ 204 $ 227 Liabilities: Operating lease liabilities, current portion 107 113 Operating lease liabilities, long term portion 123 144 Total operating lease liabilities $ 230 $ 257 |
Future Minimum Lease Payments for Non-cancellable Operating Leases | Future minimum lease payments under the operating leases were as follows: March 31, 2021 2021 $ 104 2022 131 2023 24 Total lease payments 259 Less: imputed discount rate (29 ) Carrying value of operating lease liabilities $ 230 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Payables And Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consisted of the following: March 31, 2021 December 31, 2020 Accrued R&D projects $ 2,606 $ 1,754 Accrued consulting and professional fees 662 560 Accrued compensation and benefits 471 954 Other 108 158 $ 3,847 $ 3,426 |
Debt (Tables)
Debt (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Debt Disclosure [Abstract] | |
Schedule of Outstanding Borrowings under SVB Term Loan | As of March 31, 2021 the Company had outstanding borrowings of $14.0 million under the SVB Term Loan and the term loan payable balance as presented on the Company’s Condensed Consolidated Balance Sheets as of March 31, 2021 and December 31, 2020 was comprised as shown below. March 31, December 31, 2021 2020 Principal outstanding under term loan $ 14,000 $ 14,000 Term loan discount-interest (140 ) (158 ) Term loan discount-unamortized deferred charges (42 ) (48 ) Term loan discount-financing costs, net of accretion (20 ) (23 ) Term loan-final payment fee 301 183 14,099 13,954 Less current portion 583 — Term loan payable, non-current $ 13,516 $ 13,954 |
Schedule of Components of Interest Expense of Term Loan | Interest expense on the SVB Term Loan, which is comprised of interest payments, accretion and amortization of term loan discounts and the accrual of the final payment fee, is shown below for the three months ended March 31, 2021. There was no such expense under the SVB Term Loan for the three months ended March 31, 2020. Three months ended March 31, 2021 Interest payments $ 149 Accretion and amortization of term loan discounts 27 Accrual of the final payment fee 118 $ 294 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Stockholders Equity Note [Abstract] | |
Schedule of Common Stock Reserved for Future Issuance | As of March 31, 2021 and December 31, 2020, the Company had reserved 4,573,538 March 31, 2021 December 31, 2020 Shares of common stock reserved for future issuance under the 2012 Stock Incentive Plan 921,824 921,824 Shares of common stock reserved for future issuance under the 2019 Stock Incentive Plan 3,138,793 2,396,922 Shares of common stock reserved for future issuance under the 2019 Employee Stock Purchase Plan 512,921 327,454 4,573,538 3,646,200 |
Schedule of Share-based Compensation, Stock Options, Activity | A summary of the Company’s combined stock option activity for the 2019 Plan and the 2012 Plan for the three months ended March 31, 2021 is as follows: Number of Option Shares Weighted Average Exercise Price Outstanding as of December 31, 2020 2,171,477 $ 5.62 Granted 1,074,875 $ 3.18 Forfeited — $ - Expired (1,151 ) $ 10.00 Exercised — $ - Outstanding as of March 31, 2021 3,245,201 $ 4.81 Options exercisable as of March 31, 2021 1,189,551 $ 4.87 Options unvested as of March 31, 2021 2,055,650 $ 4.77 |
Schedule of Stock-based Compensation Expenses Recognized | The following table summarizes the classifications of stock-based compensation expenses for the 2012 Plan, the 2019 Plan and the 2019 ESPP recognized in the Condensed Consolidated Statements of Operations: Three Months Ended March 31, 2021 2020 Research and development expense $ 173 $ 93 General and administrative expense 545 637 $ 718 $ 730 |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Earnings Per Share [Abstract] | |
Schedule of Earnings Per Share, Basic and Diluted | The following table summarizes the computation of basic and diluted net loss per share attributable to common stockholders of the Company: Three Months Ended March 31, 2021 2020 Net loss $ (8,371 ) $ (8,473 ) Weighted average common shares used in net loss per share attributable to common stockholders, basic and diluted 19,417,038 17,834,570 Basic and diluted net loss per common share outstanding $ (0.43 ) $ (0.48 ) |
Nature of the Business - Additi
Nature of the Business - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |||
Net income loss | $ (8,371) | $ (8,473) | $ (32,800) |
Retained earnings accumulated deficit | (155,348) | (146,977) | |
Cash and cash equivalents, at carrying value | $ 41,570 | $ 45,001 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Schedule of Financial Assets and Financial Liabilities Measured at Fair Value on Recurring Basis (Detail) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Financial liabilities carried at fair value: | ||
Term loan derivative liability | $ 202 | $ 196 |
Fair Value, Measurements, Recurring [Member] | Level 1 [Member] | Money Market Funds [Member] | ||
Financial assets carried at fair value: | ||
Money market funds | 40,772 | 44,095 |
Fair Value, Measurements, Recurring [Member] | Level 3 [Member] | Term Loan Derivative Liability [Member] | ||
Financial liabilities carried at fair value: | ||
Term loan derivative liability | $ 202 | $ 196 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Fair Value, Financial Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation (Detail) - Fair Value, Measurements, Recurring [Member] - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2021 | Dec. 31, 2020 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Balance at beginning of year | $ 196 | $ 187 |
Ending balance | 202 | 196 |
Term Loan Derivative Liability [Member] | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Change in fair value of term loan derivative liability | $ 6 | $ 9 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2021 | Dec. 31, 2020 | |
Summary Of Significant Accounting Policies [Line Items] | ||
Dividends, common stock, cash | $ 0 | |
Accounting Standards Update No. 2019-12 [Member] | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Change In Accounting Principle Accounting Standards Update Adopted | true | |
Change in Accounting Principle, Accounting Standards Update, Adoption Date | Jan. 1, 2021 | |
Change in Accounting Principle, Accounting Standards Update, Immaterial Effect | true | |
ATM Sales Agreement [Member] | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Deferred offering costs | $ 162,000 | $ 284,000 |
Reduction in stockholders' equity | $ 279,000 | $ 105,000 |
Computer Equipment [Member] | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Property, Equipment and leasehold improvements, useful life | 3 years | |
Furniture and Office Equipment [Member] | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Property, Equipment and leasehold improvements, useful life | 5 years |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets - Schedule of Prepaid Expenses and Other Current Assets (Detail) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Prepaid Expense And Other Assets Current [Abstract] | ||
Prepaid corporate insurance | $ 174 | $ 562 |
Prepaid R&D payments | 170 | 333 |
Other | 245 | 373 |
Prepaid expenses and other current assets | $ 589 | $ 1,268 |
Leases - Additional Information
Leases - Additional Information (Detail) $ in Thousands | Mar. 01, 2018USD ($)ft² | Mar. 31, 2021USD ($)Lease | Mar. 31, 2020USD ($) |
Operating lease, weighted average discount rate, percent | 13.00% | ||
Number of new leases | Lease | 0 | ||
Remaining terms | 2 years | ||
Operating Lease, Payments | $ 34 | $ 45 | |
Building [Member] | |||
Leased spaced area | ft² | 5,600 | ||
Operating lease term | 60 months | ||
Building [Member] | Minimum [Member] | |||
Operating lease rent expense | $ 10 | ||
Building [Member] | Maximum [Member] | |||
Operating lease rent expense | $ 11 | ||
Office Equipment [Member] | |||
Operating lease rent expense | $ 30 | $ 34 |
Leases - Schedule of Balance Sh
Leases - Schedule of Balance Sheet Operating Leases (Detail) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Assets: | ||
Operating lease right-of-use asset | $ 204 | $ 227 |
Liabilities: | ||
Operating lease liability - current portion | 107 | 113 |
Operating lease liability - long term portion | 123 | 144 |
Total operating lease liabilities | $ 230 | $ 257 |
Leases - Future Minimum Lease P
Leases - Future Minimum Lease Payments (Detail) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Leases [Abstract] | ||
2021 | $ 104 | |
2022 | 131 | |
2023 | 24 | |
Total lease payments | 259 | |
Less: imputed discount rate | (29) | |
Carrying value of operating lease liabilities | $ 230 | $ 257 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Detail) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Payables And Accruals [Abstract] | ||
Accrued R&D projects | $ 2,606 | $ 1,754 |
Accrued consulting and professional fees | 662 | 560 |
Accrued compensation and benefits | 471 | 954 |
Other | 108 | 158 |
Total Accrued expenses | $ 3,847 | $ 3,426 |
Debt - Additional Information (
Debt - Additional Information (Detail) | Aug. 13, 2020USD ($)Installment | Mar. 31, 2021USD ($) | Mar. 31, 2020USD ($) | Jun. 30, 2021USD ($) | Dec. 31, 2020USD ($) | Aug. 31, 2020USD ($) |
Interest expense | $ 294,000 | |||||
SVB Term Loan [Member] | ||||||
Debt instrument, principal amount | $ 14,000,000 | $ 14,000,000 | $ 14,000,000 | |||
Interest-only payment period | 24 months | |||||
Loan payment, number of consecutive equal monthly installments of principal including accrued interest | Installment | 24 | |||||
Debt instrument, maturity date | Feb. 1, 2024 | |||||
Debt instrument, final payment fee amount | $ 1,200,000 | $ 1,200,000 | ||||
Debt instruments percentage of required to deposit unrestricted and unencumbered cash collateral | 100.00% | |||||
Equity raise requirements, description | If the Company fails to meet certain equity raise requirements under the SVB Loan Agreement, including raising $12.0 million by June 30, 2021, the Company will be required to deposit unrestricted and unencumbered cash equal to 100% of the principal amount of the SVB Term Loan then outstanding in a cash collateral account with SVB, which can be used by SVB to prepay the SVB Term Loan at any time. | |||||
Debt default additional interest charge | 5.00% | |||||
Debt finance costs | $ 57,000 | |||||
Amortization of deferred financing charges | $ 6,000 | |||||
Unamortized deferred charges | 42,000 | 48,000 | ||||
Financing costs paid | $ 27,000 | |||||
Accretion loan discounts | 3,000 | |||||
Loan discounts-financing costs | 20,000 | 23,000 | ||||
Debt instrument, accrued final payment fee | $ 301,000 | 183,000 | ||||
Contingent interest rate increase | 2.00% | |||||
Fair value of liabilities | $ 6,000 | |||||
Amortization of term loan | 18,000 | |||||
Term loan discount interest | 140,000 | 158,000 | ||||
Interest expense | 294,000 | $ 0 | ||||
SVB Term Loan [Member] | Term Loan Derivative Liability [Member] | ||||||
Term loan derivative liability | $ 187,000 | $ 202,000 | $ 196,000 | |||
SVB Term Loan [Member] | Term Loan Derivative Liability [Member] | Contingent Interest Rate Increase [Member] | ||||||
Derivative liability, measurement input | 0.0200 | |||||
SVB Term Loan [Member] | Term Loan Derivative Liability [Member] | Discount Rate [Member] | ||||||
Derivative liability, measurement input | 0.120 | |||||
SVB Term Loan [Member] | Minimum [Member] | ||||||
Interest rate, floating | 4.25% | |||||
Long term debt percentage bearing adjusted floating interest rate | 6.25% | |||||
SVB Term Loan [Member] | Prepayment Prior to First Anniversary of Effective Date [Member] | ||||||
Prepayment premium percentage on principal amount | 3.00% | |||||
SVB Term Loan [Member] | Prepayment After First Anniversary of Effective Date and Prior To Second Anniversary of Effective Date [Member] | ||||||
Prepayment premium percentage on principal amount | 2.00% | |||||
SVB Term Loan [Member] | Prepayment After Second Anniversary of the Effective Date and Prior to February 1, 2024 [Member] | ||||||
Prepayment premium percentage on principal amount | 1.00% | |||||
SVB Term Loan [Member] | Prime Rate [Member] | ||||||
Variable interest rate | 1.00% | |||||
SVB Term Loan [Member] | Adjusted Prime Rate [Member] | ||||||
Variable interest rate | 3.00% | |||||
SVB Term Loan [Member] | Scenario Forecast [Member] | ||||||
Equity raise requirement in event of violation or default | $ 12,000,000 |
Debt - Schedule of Outstanding
Debt - Schedule of Outstanding Borrowings under SVB Term Loan (Detail) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 | Aug. 13, 2020 |
Term loan - current portion | $ 583 | ||
Term loan payable, non-current | 13,516 | $ 13,954 | |
SVB Term Loan [Member] | |||
Principal outstanding under term loan | 14,000 | 14,000 | $ 14,000 |
Term loan discount-interest | (140) | (158) | |
Term loan discount-unamortized deferred charges | (42) | (48) | |
Term loan discount-financing costs, net of accretion | (20) | (23) | |
Debt instrument, accrued final payment fee | 301 | 183 | |
Loans Payable, Noncurrent | 14,099 | 13,954 | |
Term loan - current portion | 583 | ||
Term loan payable, non-current | $ 13,516 | $ 13,954 |
Debt - Schedule of Components o
Debt - Schedule of Components of Interest Expense of Term Loan (Detail) - USD ($) | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Debt Instrument [Line Items] | ||
Interest expense | $ 294,000 | |
SVB Term Loan [Member] | ||
Debt Instrument [Line Items] | ||
Interest payments | 149,000 | |
Accretion and amortization of term loan discounts | 27,000 | |
Accrual of the final payment fee | 118,000 | |
Interest expense | $ 294,000 | $ 0 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |
Jun. 30, 2020 | Mar. 31, 2021 | Mar. 31, 2021 | Dec. 31, 2020 | |
Stockholders Equity [Line Items] | ||||
Preferred stock, shares authorized | 5,000,000 | 5,000,000 | 5,000,000 | |
Common stock, shares authorized | 200,000,000 | 200,000,000 | 200,000,000 | |
Common stock, par or stated value per share | $ 0.001 | $ 0.001 | $ 0.001 | |
Common stock, capital shares reserved for future issuance | 4,573,538 | 4,573,538 | 3,646,200 | |
Estimated commissions and allocated fees | $ 31,000 | |||
ATM Sales Agreement [Member] | ||||
Stockholders Equity [Line Items] | ||||
Aggregate offering price of common stock which may issue and sell under agreement | $ 12,000,000 | |||
Sale of stock during the period | 1,367,621 | 2,055,497 | ||
Proceeds from issuance of common stock | $ 4,400,000 | $ 7,600,000 | ||
Estimated commissions and allocated fees | $ 300,000 | $ 500,000 |
Stockholders' Equity - Shares R
Stockholders' Equity - Shares Reserved For Future Issuances (Detail) - shares | Mar. 31, 2021 | Dec. 31, 2020 |
Class Of Stock [Line Items] | ||
Common Stock, Capital Shares Reserved for Future Issuance | 4,573,538 | 3,646,200 |
2012 Stock Option And Grant Plan [Member] | 2012 Stock Incentive Plan [Member] | ||
Class Of Stock [Line Items] | ||
Common Stock, Capital Shares Reserved for Future Issuance | 921,824 | 921,824 |
2019 Stock Option And Grant Plan [Member] | 2019 Stock Incentive Plan [Member] | ||
Class Of Stock [Line Items] | ||
Common Stock, Capital Shares Reserved for Future Issuance | 3,138,793 | 2,396,922 |
2019 Stock Option And Grant Plan [Member] | 2019 Employee Stock Purchase Plan [Member] | ||
Class Of Stock [Line Items] | ||
Common Stock, Capital Shares Reserved for Future Issuance | 512,921 | 327,454 |
Stockholders' Equity (Stock-Bas
Stockholders' Equity (Stock-Based Awards) - Additional Information (Detail) - shares | Jan. 01, 2021 | Jan. 01, 2020 | Apr. 30, 2019 | Mar. 31, 2021 | Dec. 31, 2020 |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Common stock, capital shares reserved for future issuance | 4,573,538 | 3,646,200 | |||
Share based compensation options to purchase no of common stock | 3,245,201 | 2,171,477 | |||
Share based compensation options grants in the period | 1,074,875 | ||||
2019 Stock Incentive Plan [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Share based compensation, award description | The total number of shares of common stock that may be issued under the 2019 Plan and the 2012 Plan was 4,060,617 as of March 31, 2021, of which 815,416 shares remained available for grant under the 2019 Plan. As of March 31, 2021, awards may be made under the 2019 Plan for up to such number of shares of the Company’s common stock as is equal to the sum of i) 1,578,947 shares; plus ii) the number of shares (up to 1,157,894 shares) equal to the number of shares of the Company’s common stock subject to outstanding awards under the 2012 Stock Incentive Plan (the “2012 Plan”) that expire, terminate or are otherwise cancelled, forfeited or repurchased by the Company at their original issuance price pursuant to a contractual repurchase right; plus iii) an annual increase to be added on the first day of each fiscal year, beginning with 2020 and continuing through 2029, equal to the least of (a) 2,105,623 shares of common stock, (b) 4% of the number of outstanding shares of the Company’s common stock on such date, and (c) an amount determined by the Company’s board of directors. | ||||
Number of shares available for grant | 815,416 | ||||
Common stock, capital shares reserved for future issuance | 741,871 | 713,383 | 1,578,947 | ||
Share based compensation grant period | 10 years | ||||
Share based compensation vesting description | Options granted under the 2019 Plan and the 2012 Plan have a maximum term of ten years. Options granted to employees, officers and non-employees generally vest over four years based on varying vesting schedules that primarily include: 25% vesting on the first anniversary date of grant and the balance ratably over the next 36 months or vesting in equal monthly or quarterly installments over four years. | ||||
Share based compensation options to purchase no of common stock | 2,323,377 | 1,249,653 | |||
2019 Stock Incentive Plan [Member] | Employees, Officers and Non-employee Consultants [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Share based compensation vesting period | 4 years | ||||
2019 Stock Incentive Plan [Member] | Employees, Officers and Non-employee Consultants [Member] | Vesting First Anniversary Date of Grant [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Share based compensation vesting Percentage | 25.00% | ||||
2019 Stock Incentive Plan [Member] | Minimum [Member] | Director [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Share based compensation vesting period | 1 year | ||||
2019 Stock Incentive Plan [Member] | Maximum [Member] | Director [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Share based compensation vesting period | 2 years | ||||
2019 Stock Incentive Plan [Member] | Common Stock [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Increase in additional number of shares to be issued | 2,105,623 | ||||
Percentage of number of common stock, shares outstanding | 4.00% | 4.00% | |||
2019 Plan and 2012 Plan [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Total number of common shares authorized under the plan | 4,060,617 | ||||
2012 Stock Incentive Plan [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Share based compensation grant period | 10 years | ||||
Share based compensation vesting description | Options granted under the 2019 Plan and the 2012 Plan have a maximum term of ten years. Options granted to employees, officers and non-employees generally vest over four years based on varying vesting schedules that primarily include: 25% vesting on the first anniversary date of grant and the balance ratably over the next 36 months or vesting in equal monthly or quarterly installments over four years. | ||||
Share based compensation options to purchase no of common stock | 921,824 | 921,824 | |||
2012 Stock Incentive Plan [Member] | Stock Option [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Share based compensation options grants in the period | 0 | ||||
2012 Stock Incentive Plan [Member] | Other Equity-Based Award [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Share based compensation options grants in the period | 0 | ||||
2012 Stock Incentive Plan [Member] | Employees, Officers and Non-employee Consultants [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Share based compensation vesting period | 4 years | ||||
2012 Stock Incentive Plan [Member] | Employees, Officers and Non-employee Consultants [Member] | Vesting First Anniversary Date of Grant [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Share based compensation vesting Percentage | 25.00% | ||||
2012 Stock Incentive Plan [Member] | Minimum [Member] | Director [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Share based compensation vesting period | 1 year | ||||
2012 Stock Incentive Plan [Member] | Maximum [Member] | Director [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Share based compensation vesting period | 2 years | ||||
2012 Stock Incentive Plan [Member] | Common Stock [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Share based compensation options to purchase number of shares outstanding | 1,157,894 | ||||
2019 Employee Stock Purchase Plan [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Share based compensation, award description | The total number of shares of common stock that may be issued under the 2019 ESPP Plan was 518,918 as of March 31, 2021, of which 512,921 shares remained available for issuance. The number of shares of the Company’s common stock that have been approved to be issued under the 2019 ESPP is equal to the sum of i) 155,106 shares plus ii) an annual increase to be added on the first day of each fiscal year, beginning with the fiscal year ending December 31, 2020 and continuing for each fiscal year until, and including, the fiscal year ending December 31, 2029, equal to the least of (a) 526,315 shares of common stock, (b) 1% of the number of outstanding shares of the Company’s common stock on such date, and (c) an amount determined by the Company’s board of directors. Effective January 1, 2021 and January 1, 2020, respectively, the aggregate number of shares of the Company’s common stock that may be issued under the 2019 ESPP increased, pursuant to the terms of the 2019 ESPP, by an additional 185,467 shares and 178,345 shares, equal to 1% of the Company’s then-outstanding common stock | ||||
Total number of common shares authorized under the plan | 518,918 | ||||
Number of shares available for grant | 512,921 | ||||
Common stock, capital shares reserved for future issuance | 155,106 | ||||
2019 Employee Stock Purchase Plan [Member] | Common Stock [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Increase in additional number of shares to be issued | 185,467 | 178,345 | 526,315 | ||
Percentage of number of common stock, shares outstanding | 1.00% | 1.00% | 1.00% |
Stockholders' Equity - Stock Op
Stockholders' Equity - Stock Options, Activity (Detail) | 3 Months Ended |
Mar. 31, 2021$ / sharesshares | |
Number of Option Shares | |
Outstanding, Beginning | shares | 2,171,477 |
Granted | shares | 1,074,875 |
Expired | shares | (1,151) |
Outstanding, Ending | shares | 3,245,201 |
Options exercisable | shares | 1,189,551 |
Options unvested | shares | 2,055,650 |
Weighted Average Exercise Price | |
Outstanding, Beginning | $ / shares | $ 5.62 |
Granted | $ / shares | 3.18 |
Expired | $ / shares | 10 |
Outstanding, Ending | $ / shares | 4.81 |
Options exercisable | $ / shares | 4.87 |
Options unvested | $ / shares | $ 4.77 |
Stockholders' Equity - Stock-ba
Stockholders' Equity - Stock-based Compensation Expenses (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Stock-based compensation | $ 718 | $ 730 |
Research and Development Expense [Member] | ||
Stock-based compensation | 173 | 93 |
General and Administrative Expense [Member] | ||
Stock-based compensation | $ 545 | $ 637 |
Net Loss per Share - Computatio
Net Loss per Share - Computation of Basic and Diluted Net Loss Per Share Attributable to Common Stockholders (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 | |
Earnings Per Share [Abstract] | |||
Net loss | $ (8,371) | $ (8,473) | $ (32,800) |
Weighted average common shares used in net loss per share attributable to common stockholders, basic and diluted | 19,417,038 | 17,834,570 | |
Basic and diluted net loss per common share outstanding | $ (0.43) | $ (0.48) |
Collaborative and Licensing A_2
Collaborative and Licensing Agreements - Additional Information (Detail) - USD ($) $ in Thousands | May 23, 2011 | Nov. 30, 2018 | Mar. 31, 2021 |
Endo Pharmaceuticals Inc [Member] | |||
Upfront license fee | $ 25 | ||
Royalty terms | first commercial sale of the product in that country and extends until the later of the expiration, unenforceability or invalidation of the last valid claim of any licensed patent or application covering the licensed product in the country or the expiration of 10 years after the first commercial sale of the licensed product in the country, which period is referred to as the royalty term. Upon the expiration of the royalty term for a product in a country | ||
Endo Pharmaceuticals Inc [Member] | Completion Of Stage One [Member] | |||
Milestone payments to be paid | $ 250 | ||
Endo Pharmaceuticals Inc [Member] | Completion Of Stage Two [Member] | |||
Milestone payments to be paid | 750 | ||
Rutgers [Member] | |||
Milestone payments to be paid | $ 331 | ||
Royalty terms | first commercial sale of the licensed product in that country following receipt of marketing approval and extends until the later of the date of expiration, unenforceability or invalidation of the last valid claim of any licensed patent or patent application covering the licensed product in the country and 10 years after the first commercial sale of the first licensed product sold anywhere in the world, which period is referred to as the royalty term. Upon the expiration of the royalty term for a licensed product in a country, the license granted to the Company under the agreement shall become perpetual, fully paid-up, irrevocable and royalty-free in such country. | ||
MentiNova, LLC [Member] | |||
Upfront license fee | $ 119 | ||
MentiNova, LLC [Member] | Completion Of Stage One [Member] | |||
Milestone payments to be paid | $ 1,200 |