Cover
Cover - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Mar. 15, 2021 | Jun. 30, 2020 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2020 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-35890 | ||
Entity Registrant Name | Millendo Therapeutics, Inc. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 45-1472564 | ||
Entity Address, State or Province | MI | ||
Entity Address, City or Town | Ann Arbor | ||
Entity Address, Address Line Two | Suite 100 | ||
Entity Address, Address Line One | 110 Miller Avenue | ||
Entity Address, Postal Zip Code | 48104 | ||
City Area Code | 734 | ||
Local Phone Number | 845-9000 | ||
Title of 12(b) Security | Common Stock, $0.001 par value | ||
Trading Symbol | MLND | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 33.3 | ||
Entity Common Stock, Shares Outstanding | 19,043,034 | ||
Documents Incorporated by Reference | Portions of the registrant’s definitive Proxy Statement for its 2021 Annual Meeting of Stockholders to be filed with the Securities and Exchange Commission pursuant to Regulation 14A not later than 120 days after the end of the fiscal year covered by this Annual Report on Form 10-K are incorporated by reference in Part III, Items 10-14 of this Annual Report on Form 10-K. | ||
Entity Central Index Key | 0001544227 | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2020 | ||
Document Fiscal Period Focus | FY |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 38,174 | $ 62,478 |
Short-term restricted cash | 484 | 1,034 |
Prepaid expenses and other current assets | 1,929 | 6,344 |
Refundable tax credit | 314 | 1,276 |
Total current assets | 40,901 | 71,132 |
Operating lease right-of-use assets | 2,157 | 3,331 |
Other assets | 351 | 507 |
Total assets | 43,409 | 74,970 |
Current liabilities: | ||
Current portion of debt | 239 | 208 |
Accounts payable | 1,486 | 1,495 |
Accrued expenses | 5,525 | 9,066 |
Operating lease liabilities - current | 737 | 1,751 |
Total current liabilities | 7,987 | 12,520 |
Debt, net of current portion | 61 | 168 |
Operating lease liabilities | 1,635 | 2,395 |
Other liabilities | 0 | 16 |
Total liabilities | 9,683 | 15,099 |
Commitments and contingencies (Note 7) | ||
Stockholders’ equity: | ||
Preferred stock, $0.001 par value: 5,000,000 shares authorized; no shares issued and outstanding | 0 | 0 |
Common stock, $0.001 par value: 100,000,000 shares authorized; 18,999,701 shares and 18,266,545 shares issued and outstanding at December 31, 2020 and 2019, respectively | 19 | 18 |
Additional paid-in capital | 277,647 | 267,018 |
Accumulated deficit | (245,060) | (208,654) |
Accumulated other comprehensive income | 452 | 165 |
Total stockholders’ equity attributable to Millendo Therapeutics, Inc. | 33,058 | 58,547 |
Equity attributable to noncontrolling interests | 668 | 1,324 |
Total stockholders’ equity | 33,726 | 59,871 |
Total liabilities and stockholders’ equity | $ 43,409 | $ 74,970 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2020 | Dec. 31, 2019 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in usd per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in usd per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 100,000,000 | 100,000,000 |
Common stock, shares issued (in shares) | 18,999,701 | 18,266,545 |
Common stock, shares outstanding (in shares) | 18,999,701 | 18,266,545 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Operating expenses: | ||
Research and development | $ 20,374 | $ 27,843 |
General and administrative | 15,598 | 17,556 |
Loss from operations | 35,972 | 45,399 |
Other expenses: | ||
Interest income, net | (155) | (1,038) |
Other loss | 589 | 207 |
Net loss | $ (36,406) | $ (44,568) |
Net loss per share of common stock, basic and diluted (in USD per share) | $ (1.93) | $ (3.25) |
Weighted-average shares of common stock outstanding, basic and diluted (in shares) | 18,862,537 | 13,706,744 |
Other comprehensive income (loss): | ||
Foreign currency translation adjustment | $ 287 | $ 17 |
Comprehensive loss | $ (36,119) | $ (44,551) |
Consolidated Statements of Conv
Consolidated Statements of Convertible Preferred Stock, Redeemable Noncontrolling Interests and Stockholders’ Equity (Deficit) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Income | Total Stockholders’ (Deficit) attributable to Millendo Therapeutics, Inc. | Total Equity Attributable to Noncontrolling Interests |
Balance at beginning (in shares) at Dec. 31, 2018 | 13,357,999 | ||||||
Balance at beginning at Dec. 31, 2018 | $ 73,122 | $ 13 | $ 234,876 | $ (164,086) | $ 148 | $ 70,951 | $ 2,171 |
Stockholders' Equity | |||||||
Exercise of stock options (in shares) | 97,225 | 97,225 | |||||
Exercise of stock options | $ 361 | 361 | 361 | ||||
Issuance of common stock to board of directors (in shares) | 1,941 | ||||||
Issuance of common stock to board of directors | 20 | 20 | 20 | ||||
Issuance of common stock, net of issuance costs (in shares) | 4,791,667 | ||||||
Issuance of common stock, net of issuance costs | 26,491 | $ 5 | 26,486 | 26,491 | |||
Exercise/forfeiture of BSPCE warrants (in shares) | 17,713 | ||||||
Exercise/forfeiture of BSPCE warrants | 111 | 958 | 958 | (847) | |||
Stock-based compensation expense | 4,317 | 4,317 | 4,317 | ||||
Foreign currency translation adjustment | 17 | 17 | 17 | ||||
Net income (loss) | (44,568) | (44,568) | (44,568) | ||||
Balance at end (in shares) at Dec. 31, 2019 | 18,266,545 | ||||||
Balance at end at Dec. 31, 2019 | $ 59,871 | $ 18 | 267,018 | (208,654) | 165 | 58,547 | 1,324 |
Stockholders' Equity | |||||||
Exercise of stock options (in shares) | 1,449 | 1,449 | |||||
Exercise of stock options | $ 2 | 2 | 2 | ||||
Issuance of common stock, net of issuance costs (in shares) | 719,400 | ||||||
Issuance of common stock, net of issuance costs | 5,650 | $ 1 | 5,649 | 5,650 | |||
Exercise/forfeiture of BSPCE warrants (in shares) | 12,307 | ||||||
Exercise/forfeiture of BSPCE warrants | 78 | 734 | 734 | (656) | |||
Stock-based compensation expense | 4,244 | 4,244 | 4,244 | ||||
Foreign currency translation adjustment | 287 | 287 | 287 | ||||
Net income (loss) | (36,406) | (36,406) | (36,406) | ||||
Balance at end (in shares) at Dec. 31, 2020 | 18,999,701 | ||||||
Balance at end at Dec. 31, 2020 | $ 33,726 | $ 19 | $ 277,647 | $ (245,060) | $ 452 | $ 33,058 | $ 668 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Operating activities: | ||
Net loss | $ (36,406) | $ (44,568) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 152 | 97 |
Stock-based compensation expense | 4,244 | 4,317 |
Foreign currency remeasurement loss | 321 | 0 |
Amortization of right-of-use asset | 952 | 955 |
Other non-cash items | 6 | 30 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 5,361 | (698) |
Other assets | 21 | 66 |
Accounts payable | 25 | (469) |
Accrued expenses and other liabilities | (3,559) | 281 |
Operating lease liabilities | (1,552) | (1,233) |
Cash used in operating activities | (30,435) | (41,222) |
Investing activities: | ||
Purchase of property and equipment | (26) | (397) |
Proceeds from sale of marketable securities | 0 | 4,385 |
Cash (used in) provided by investing activities | (26) | 3,988 |
Financing activities: | ||
Repayment of debt | (108) | (184) |
Proceeds from the issuance of common stock, net of issuance costs | 5,453 | 26,688 |
Proceeds from sale of private placement, net of issuance costs | 0 | (15) |
Repayment of principal on finance lease | (37) | (18) |
Proceeds from option and BSPCE warrant exercises | 78 | 472 |
Cash provided by financing activities | 5,386 | 26,943 |
Effect of foreign currency exchange rate changes on cash | 221 | 33 |
Net decrease in cash, cash equivalents and restricted cash | (24,854) | (10,258) |
Cash, cash equivalents and restricted cash at beginning of period | 63,512 | 73,770 |
Cash, cash equivalents and restricted cash at end of period | 38,658 | 63,512 |
Supplemental schedule of non-cash investing and financing activities: | ||
Financing costs in accounts payable and accrued expenses | 0 | 197 |
Right-of-use assets acquired under operating leases | $ 0 | $ 3,414 |
Organization and Description of
Organization and Description of Business | 12 Months Ended |
Dec. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Description of Business | Organization and Description of Business Description of Business Millendo Therapeutics, Inc. (the “Company”), a Delaware corporation, together with its subsidiaries, is a biopharmaceutical company that was previously primarily focused on developing novel treatments for orphan endocrine diseases where current therapies do not exist or are insufficient. The Company had been developing livoletide (AZP-531), as a potential treatment for Prader-Willi syndrome, (“PWS”), a rare and complex genetic endocrine disease characterized by hyperphagia, or insatiable hunger. The Company discontinued the development of livoletide as a potential treatment for PWS in April 2020 based upon results from its Phase 2b trial. All costs, including estimated closeout costs associated with the livoletide program were recognized during the second quarter, which resulted in the Company recording $3.1 million in the second quarter of 2020. The Company recorded additional expense in the second half of 2020 related to the livoletide program, which reflects changes to estimated closeout costs. The Company does not expect to incur future material expenses related to this program. In an effort to streamline costs after discontinuing the PWS program, the Company eliminated employee positions representing approximately 30% of its prior headcount, which were completed in the second quarter of 2020. The Company recorded one-time costs of $1.1 million in the form of termination benefits to this plan in the second quarter of 2020. The Company had also been developing nevanimibe (ATR-101) as a potential treatment for patients with classic congenital adrenal hyperplasia, (“CAH”), a rare, monogenic adrenal disease that requires lifelong treatment with exogenous cortisol, often at high doses. The Company elected to cease investing in the development of nevanimibe as a potential treatment for CAH in June 2020 based on an interim review of data from its Phase 2b trial. All costs, including estimated closeout costs associated with the nevanimibe program for the treatment of CAH were recognized during the second quarter of 2020. The Company recorded additional expense in the second half of 2020 related to the nevanimibe program, which reflects changes to estimated close out costs. The Company does not expect to incur future material expenses related to its nevanimibe program for the treatment of CAH as it is no longer developing this program The Company had also been developing a selective neurokinin 3-receptor (NK3R) antagonist (MLE-301) as a potential treatment of vasomotor symptoms (“VMS”), commonly known as hot flashes and night sweats, in menopausal women. In January 2021, the Company discontinued further investment in MLE-301 for the treatment of VMS based on an analysis of the pharmacokinetic and pharmacodynamic data from the single ascending dose portion of the Phase 1 study. In January 2021, as a result of its decision to discontinue its investment in MLE-301, the Company's Board of Directors (the “Board”) also approved a corporate restructuring plan (the “Plan”) furthering the Company's ongoing efforts to align its resources with its current strategy and operations. In connection with the Plan, the Company plans to reduce its workforce by up to 85%, with the majority of the reduction in personnel expected to be completed by April 15, 2021. The Company initiated this reduction in force in January 2021 and expects to provide severance payments and continuation of group health insurance coverage for a specified period to the affected employees. The Company has also entered into retention arrangements with employees who are expected to remain with the Company. The Company estimates that it will incur costs of approximately $5.5 million for termination benefits and retention arrangements related to the Plan, substantially all of which will be cash expenditures. In 2020, the Company undertook a strategic review process, which was intended to result in an actionable plan that leverages its assets, capital and capabilities to maximize stockholder value. Following an extensive process of evaluating strategic alternatives, including identifying and reviewing potential candidates for a strategic acquisition or other transaction, on March 29, 2021, the Company entered into an Agreement and Plan of Merger (the “Merger Agreement”), with Tempest Therapeutics, Inc. (“Tempest”) under which the privately held Tempest will merge with a wholly owned subsidiary of Millendo (the “Merger”). If the Merger is completed, the business of Tempest will continue as the business of the combined company (see Note 12). The Company had also been investigating nevanimibe (ATR-101) as a potential treatment for patients with endogenous Cushing's syndrome (“CS”), a rare endocrine disease characterized by excessive cortisol production from the adrenal glands. As a result of slower than anticipated enrollment in its CS Phase 2 clinical trial, the Company elected to discontinue this trial in August 2019, suspend development of nevanimibe for the treatment of CS, and focus its resources on other programs in its research and development pipeline. Liquidity The Company has incurred net losses since inception and it expects to generate losses from operations for the foreseeable future primarily due to the ongoing review of corporate strategic alternatives that include, but are not limited to, the potential sale or merger of the Company or its assets. As of December 31, 2020, the Company had cash, cash equivalents and restricted cash of $38.7 million and an accumulated deficit of $245.1 million. In December 2019, the Company sold a total of 4,791,667 shares of its common stock pursuant to an underwriting agreement (the “Underwriting Agreement”) with Citigroup Global Markets Inc. and SVB Leerink LLC, as representatives of the several underwriters named therein (the “Underwriters”), for total net proceeds of approximately $26.5 million, after deducting underwriting discounts and commissions and other offering expenses payable by the Company. The price to the public in this offering was $6.00 per share and resulted in the sale of 4,166,667 shares of the Company's common stock for net proceeds of approximately $23.0 million, after deducting underwriting discounts and commissions and other offering expenses payable by the Company. In addition, the Underwriters purchased an additional 625,000 shares of the Company's common stock at the public offering price of $6.00 per share pursuant to a purchase option granted to them under the Underwriting Agreement, resulting in net proceeds of approximately $3.5 million, after deducting underwriting discounts and commissions. In April 2019, the Company entered into an “at-the-market” (“ATM”) equity distribution agreement with Citigroup Global Markets Inc. acting as sole agent with an aggregate offering value of up to $50.0 million, which allows the Company to sell its common stock through the facilities of the Nasdaq Capital Market. Subject to the terms of the ATM equity distribution agreement, the Company is able to determine, at its sole discretion, the timing and number of shares to be sold under this ATM facility. In March 2020, the Company amended the equity distribution agreement to include SVB Leerink LLC as an additional sales agent for the ATM. In March 2020, the Company sold 719,400 shares of its common stock under our ATM equity distribution agreement for net proceeds of approximately $5.5 million. The Company does not expect to sell additional shares of common stock under the equity distribution agreement. Given its limited expected financing options, the Company is currently exploring an expanded range of strategic alternatives that include, but are not limited to, the potential sale or merger of the Company or its assets. In the event that the Company does not complete the Merger with Tempest, the Company (i) may elect to pursue a dissolution and liquidation of the Company, (ii) pursue another strategic transaction or (iii) may resume research and development activities. The Company believes its cash, cash equivalents and restricted cash at December 31, 2020 are sufficient to fund its current operations for at least 12 months following the issuance of these financial statements. |
Basis of Presentation and Summa
Basis of Presentation and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Summary of Significant Accounting Policies | Basis of Presentation and Summary of Significant Accounting Policies Basis of presentation and consolidation principles The accompanying Consolidated Financial Statements include the accounts of Millendo Therapeutics, Inc. and its subsidiaries, and all intercompany amounts have been eliminated. The Consolidated Financial Statements have been prepared in conformity with U.S. generally accepted accounting principles (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). The Consolidated Financial Statements include the accounts of the Company’s subsidiaries in which the Company holds a controlling financial interest as of the financial statement date. Use of estimates The preparation of the Consolidated Financial Statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Due to the uncertainty of factors surrounding the estimates or judgments used in the preparation of the Consolidated Financial Statements, actual results may materially vary from these estimates. Estimates and assumptions are periodically reviewed and the effects of revisions are reflected in the financial statements in the period they are determined to be necessary. Significant Risks and Uncertainties With the global spread of the ongoing COVID-19 pandemic in 2020, the Company has implemented business continuity plans designed to address and mitigate the impact of the COVID-19 pandemic on its business. The Company anticipates that the COVID-19 pandemic will continue to have an impact on clinical and preclinical development activities. The extent to which the COVID-19 pandemic impacts the Company’s business, its preclinical and clinical development and regulatory efforts, its corporate development objectives and the value of and market for its common stock, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the U.S., Europe and other countries, and the effectiveness of actions taken globally to contain and treat the disease. The global economic slowdown, the overall disruption of global healthcare systems and the other risks and uncertainties associated with the pandemic could have a material adverse effect on the Company’s business, financial condition, results of operations and growth prospects. In addition, the Company is subject to other challenges and risks specific to its business and its ability to execute on its strategy, as well as risks and uncertainties common to companies in the pharmaceutical industry with development operations, including, without limitation, risks and uncertainties associated with: obtaining regulatory approval of its product candidates, loss of single source suppliers or failure to comply with manufacturing regulations, identifying, acquiring or in-licensing additional products or product candidates; pharmaceutical product development and the inherent uncertainty of clinical success; and the challenges of protecting and enhancing its intellectual property rights; complying with applicable regulatory requirements. In addition, to the extent the ongoing COVID-19 pandemic adversely affects its business and results of operations, the Company may also have the effect of heightening many of the other risks and uncertainties discussed above. Concentration of credit risk Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash, cash equivalents and restricted cash. The Company generally invests its cash in deposits with high credit quality financial institutions. Deposits at banks may exceed the insurance provided on such deposits. Additionally, the Company performs periodic evaluations of the relative credit standing of these financial institutions. Cash and cash equivalents The Company considers all highly liquid investments that have maturities of three months or less when acquired to be cash equivalents. Cash equivalents as of December 31, 2020 and 2019 consisted of money market funds. Restricted cash Restricted cash relates to amounts used to secure the Company’s credit card facility balances held on deposit with major financial institutions, to collateralize a letter of credit in the name of the Company’s landlord pursuant to a certain operating lease agreement, and to fund an escrow arrangement in connection with a sublease agreement also pursuant to that same operating lease agreement. The escrow agreement ended in connection with the expiration of the Company's Waltham, Massachusetts lease agreement in November 2020 (see Note 7). The following table provides a reconciliation of the components of cash, cash equivalents, and restricted cash reported in the Company's consolidated balance sheets to the total of the amount presented in the Consolidated Statements of Cash Flows: December 31, 2020 2019 (in thousands) Cash and cash equivalents $ 38,174 $ 62,478 Restricted cash 484 1,034 Total cash, cash equivalents, and restricted cash shown in the Consolidated Statements of Cash Flows $ 38,658 $ 63,512 Refundable tax credit The Company earns French research tax credits (crédit d’impôt recherche) or (“CIR”) in connection with its research efforts through its wholly owned subsidiary in Lyon, France. CIR earned are refundable or they can offset French corporate income tax due. Since the French research tax credit can be recovered in cash, the Company has elected to treat this as a grant. During the year ended December 31, 2020 and 2019, the Company recognized a reduction of research and development expenses of $0.5 million and $1.2 million, respectively, and had a research tax credit receivable of $0.3 million and $1.3 million at December 31, 2020 and 2019, respectively. Leases The Company determines if an arrangement is a lease at contract inception. A lease exists when a contract conveys to the customer the right to control the use of identified property, plant, or equipment for a period of time in exchange for consideration. The definition of a lease embodies two conditions: (1) there is an identified asset in the contract that is land or a depreciable asset (i.e., property, plant, and equipment), and (2) the customer has the right to control the use of the identified asset. The lease liabilities are initially and subsequently measured at the present value of the unpaid lease payments at the lease commencement date. When readily determinable, the Company uses the implicit rate in determining the present value of lease payments. When leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the lease commencement date, including the lease term. The ROU asset is initially measured at cost, which comprises the initial amount of the lease liability adjusted for lease payments made at or before the lease commencement date, plus any initial direct costs incurred less any lease incentives received. For operating leases, the ROU asset is subsequently measured throughout the lease term at the carrying amount of the lease liability, plus initial direct costs, plus (minus) any prepaid (accrued) lease payments, less the unamortized balance of lease incentives received. Lease expense for lease payments is recognized on a straight-line basis over the lease term. Refer to Note 7 for further details. Fair value of financial instruments Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: • Level 1—Quoted prices in active markets for identical assets or liabilities. • Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. • Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The asset’s or liability’s fair value measurement level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. The carrying value of the Company’s debt approximates fair value as of December 31, 2020 and 2019. Other assets Other assets includes property and equipment and other assets. Property and equipment, less accumulated depreciation, are recorded at cost and are depreciated on a straight-line basis over their estimated useful lives which range from three Research and development expenses Research and development costs are expensed as incurred and consist primarily of personnel expenses, costs of funding research performed by third-parties, expenses incurred under agreements with contract manufacturing organizations, payments under third-party licensing agreements, consultant fees and expenses associated with outsourced professional scientific development services, expenses related to regulatory activities and allocated expense for facility costs. Milestone payment obligations incurred prior to regulatory approval of the product, which are accrued when the event requiring payment of the milestone occurs, are included in research and development expenses. Upfront milestone payments made to third-parties who perform research and development services on the Company’s behalf are expensed as services are rendered. At the end of each reporting period, the Company compares payments made to third-party service providers to the estimated progress toward completion of the applicable research or development objectives. Such estimates are subject to change as additional information becomes available. Depending on the timing of payments to the service providers and the progress that the Company estimates has been made as a result of the service provided, the Company may record net prepaid or accrued expense relating to these costs. As of December 31, 2020 and 2019, the Company has not made any material adjustments to its prior estimates of accrued research and development expenses. Stock-based compensation The Company measures and recognizes compensation expense for all stock options awarded to employees and nonemployees based on the estimated fair market value of the award on the grant date. The Company uses the Black-Scholes option pricing model to value its stock option awards. The Company recognizes compensation expense on a straight-line basis over the requisite service period, which is generally the vesting period of the award. The Company accounts for forfeitures of stock options as they occur. Estimating the fair market value of options requires the input of subjective assumptions, including the estimated fair value of the Company’s common stock, the expected life of the options, stock price volatility, the risk-free interest rate and expected dividends. The assumptions used in the Company’s Black-Scholes option-pricing model represent management’s best estimates and involve a number of variables, uncertainties and assumptions and the application of management’s judgment, as they are inherently subjective. Income taxes The Company recognizes deferred tax assets and liabilities for temporary differences between the financial reporting basis and the tax basis of the Company’s assets and liabilities and the expected benefits of net operating loss carryforwards. The impact of changes in tax rates and laws on deferred taxes, if any, applied during the period in which temporary differences are expected to be settled, is reflected in the Company’s financial statements in the period of enactment. The measurement of deferred tax assets is reduced, if necessary, if, based on weight of the evidence, it is more likely than not that some, or all, of the deferred tax assets will not be realized. As of December 31, 2020 and 2019, the Company has concluded that a full valuation allowance is necessary for all of its net deferred tax assets. The Company had no material amounts recorded for uncertain tax positions, interest or penalties in the accompanying Consolidated Financial Statements. Net loss per share Basic loss per share of common stock is computed by dividing net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during each period. Diluted loss per share of common stock includes the effect, if any, from the potential exercise or conversion of securities, such as restricted stock, and stock options, which would result in the issuance of incremental shares of common stock. In computing the basic and diluted net loss per share, the weighted-average number of shares of common stock remains the same for both calculations due to the fact that when a net loss exists, dilutive shares are not included in the calculation as the impact is anti-dilutive. The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares of common stock outstanding, as they would be anti-dilutive (amounts shown as common stock equivalents): Year ended December 31, 2020 2019 Stock options 3,749,102 2,498,606 Common stock warrants 17,125 17,125 BSA and BSPCE warrants 48,265 95,567 3,814,492 2,611,298 Segment information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one segment. Foreign currency Results of foreign operations are translated from their functional currency into U.S. dollars (reporting currency) using average exchange rates in effect during the year, while assets and liabilities are translated into U.S. dollars using exchange rates in effect at the balance sheet date. The resulting translation adjustments are recorded in accumulated other comprehensive loss. Transaction gains and losses resulting from exchange rate changes on transactions denominated in currencies other than the functional currency are included in income in the period in which the change occurs and reported within other expenses in the consolidated statements of operations and comprehensive loss. Recent accounting pronouncements In January 2020, the FASB issued ASU 2020-01, Investments-Equity Securities (Topic 321), Investments-Equity Method and Joint Ventures (Topic 323), and Derivatives and Hedging (Topic 815). ASU 2020-01 states any equity security transitioning from the alternative method of accounting under Topic 321 to the equity method, or vice versa, due to an observable transaction will be remeasured immediately before the transition. In addition, the ASU clarifies the accounting for certain non-derivative forward contracts or purchased call options to acquire equity securities stating such instruments will be measured using the fair value principles of Topic 321 before settlement or exercise. The ASU is effective for fiscal years beginning after December 15, 2020, and will be applied on a prospective basis. Early adoption is permitted. The Company adopted ASU 2020-01 on January 1, 2021, which did not have a material effect on the consolidated financial statements. In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740) - Simplifying the Accounting for Income Taxes. ASU 2019-12 simplifies the accounting for income taxes by removing exceptions within the general principles of Topic 740 regarding the calculation of deferred tax liabilities, the incremental approach for intraperiod tax allocation, and calculating income taxes in an interim period. In addition, the ASU adds clarifications to the accounting for franchise tax (or similar tax), which is partially based on income, evaluating tax basis of goodwill recognized from a business combination, and reflecting the effect of any enacted changes in tax laws or rates in the annual effective tax rate computation in the interim period that includes the enactment date. The ASU is effective for fiscal years beginning after December 15, 2020, and will be applied either retrospectively or prospectively based upon the applicable amendments. Early adoption is permitted. The Company adopted ASU 2019-01 on January 1, 2021, which did not have a material effect on the consolidated financial statements. In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820) Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement . ASU 2018-13 resulted in certain modifications to fair value measurement disclosures, primarily related to level 3 fair value measurements. The standard was effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019, and early adoption was permitted. The adoption of ASU 2018-13 did not have a material impact on the Company's consolidated financial statements and related disclosures. In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326) Measurement of Credit Losses on Financial Instruments , which replaces the incurred loss impairment methodology in current GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. Additionally, ASU 2016-13 requires a financial asset measured at amortized cost basis to be presented at the net amount expected to be collected through the use of an allowance of expected credit losses. In May 2019, the FASB issued ASU 2019-05, Financial Instruments - Credit Losses (Topic 326) Targeted Transition Relief , which amends ASU 2016-13 by providing entities with an option to irrevocably elect the fair value option to be applied on an instrument-by-instrument basis for eligible financial instruments that are within the scope of Topic 326. The fair value option election does not apply to held-to-maturity debt securities. In November 2019, the FASB issued ASU 2019-10, Financial Instruments - Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842) , which finalized effective date delays for private companies, not-for-profit organizations, and certain smaller reporting companies applying the credit losses, leases, and hedging standards. Also in November 2019, the FASB issued ASU 2019-11, Codification Improvements to Topic 326, Financial Instruments - Credit Losses , which provides clarity about certain aspects of the amendments in ASU 2016-13. ASU 2016-13, as amended, is effective for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years, and requires a modified retrospective approach. The Company is in the process of evaluating the impact of this new guidance on its consolidated financial statements and related disclosures. Subsequent events Subsequent events were evaluated through the filing date of this Annual Report. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements The following table presents the Company’s assets and liabilities that are measured at fair value on a recurring basis (amounts in thousands): December 31, 2020 (Level 1) (Level 2) (Level 3) Assets Money market funds (included in cash and cash equivalents) $ 33,636 $ — $ — December 31, 2019 (Level 1) (Level 2) (Level 3) Assets Money market funds (included in cash and cash equivalents) $ 59,382 $ — $ — |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2020 | |
Accrued Liabilities, Current [Abstract] | |
Accrued Expenses | Accrued Expenses Accrued expenses consist of (amounts in thousands): December 31, 2020 2019 Compensation and related benefits $ 1,978 $ 2,042 Professional fees 719 2,929 Preclinical and clinical costs 1,002 1,820 Insurance premiums 1,476 1,423 Other 350 852 Total $ 5,525 $ 9,066 |
Debt
Debt | 12 Months Ended |
Dec. 31, 2020 | |
Debt Disclosure [Abstract] | |
Debt | Debt Bpifrance Reimbursable Advance In December 2017, in connection with its acquisition of Alizé, a privately held biotechnology company based in Lyon, France, the Company assumed €0.7 million of debt that Alizé had outstanding with Bpifrance Financing (“Bpifrance”). The original advance amount of €0.8 million (“the Bpifrance Advance”) was provided to Alizé as an innovation aid that required Alizé to carry out certain activities related to its livoletide clinical development program and incur a certain level of program expenditures. No interest is charged or accrued under the advance. The Company is required to make quarterly principal payments, which began in December 2016 and continue through September 2021. The quarterly principal payments escalate over the repayment period beginning with €17,500 per quarter and increasing to €50,000 through maturity. In addition to the quarterly payments, beginning January 1, 2016, Bpifrance may require the Company to pay, by no later than March 31 of each year, a reimbursement annuity equal to 20% of the proceeds generated by the Company from license, assignment or use of livoletide. Under no circumstance, however, would the Company be required to reimburse to Bpifrance principal amounts greater than the original advance it received. The Company is permitted to repay the Bpifrance Advance at any time, at which point it would be released from all commitments and obligations under the Bpifrance Advance agreement. The Bpifrance Advance Agreement does not contain any ongoing financial covenants. |
License Agreements
License Agreements | 12 Months Ended |
Dec. 31, 2020 | |
License agreements | |
License Agreements | License Agreements University of Michigan License Agreement In June 2013, the Company entered into a license agreement with the Regents of the University of Michigan (the “University of Michigan”) for a worldwide, exclusive, sublicensable license to the University of Michigan’s interest in certain patent rights jointly owned with the Company, covering the use of ATR-101 for the treatment of certain indications (the “UM License Agreement”). Due to the Company's decision to cease investing in the nevanimibe program, effective on March 5, 2021, the Company notified the University of Michigan of its decision to terminate the UM License Agreement, which termination shall be effective April 30, 2021, as agreed to by the University of Michigan. The Company would have been obligated to make payments to the University of Michigan totaling up to $2.5 million upon the achievement of certain development and commercial milestones. No amounts were paid in 2018 or 2019 related to the achievement of development or commercial milestones. During the year ended December 31, 2019, $0.1 million was paid in order to extend the milestone achievement date of certain development milestones. The Company would have also been required to pay the University of Michigan a low-single digit royalty percentage on net sales of applicable products, if any. In addition, $20,000 in annual minimum royalties would have been due under the UM License Agreement for each of 2021 through 2023. Further, beginning in 2024, the Company would have been required to pay an annual fee of $0.2 million which would have been creditable against royalties due, if any, until the expiration or termination of the UM License Agreement. Assignment agreement with Erasmus University Medical Center and the University of Turin In connection with its acquisition of Alizé, the Company assumed Alizé’s obligations under an assignment agreement with Erasmus University Medical Center, the University of Turin and certain individuals (collectively “the Assignors”), for certain patents and patent applications relating to livoletide. In March 2021, the Company notified the assignors that it had discontinued its PWS program. In connection with the assignment, the Company agreed to pay the Assignors a flat, low single digit royalty on net commercial sales of products containing livoletide that are covered by the claims of the assigned intellectual property. Further, upon approval of livoletide by the FDA or EMA, the Company would have been required to pay the Assignors CDN $100,000, which amount would have been deducted from any future royalty payments due to the Assignors. The Company also agreed to pay the Assignors a low single digit percentage of any amounts received in connection with its license of the assigned intellectual property or products containing livoletide that are covered by the claims of the assigned intellectual property. License Agreement with Roche On October 16, 2018, the Company entered into a license agreement with F. Hoffmann-La Roche Ltd and Hoffman-La Roche Inc. (collectively, “Roche”), for a worldwide, exclusive license to Roche's interest in certain patent rights and know-how covering, among other things, the use of a neurokinin 3 receptor antagonist (the "Roche License Agreement"). Due to the Company's decision to discontinue developing the MLE-301 program, in March 2021, the Company notified Roche that it was terminating the Roche License Agreement effective three months from the date of such notice. |
Commitments
Commitments | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Operating leases The Company has noncancelable operating leases for office space which have remaining lease terms of approximately 3.5 years. In connection with the OvaScience Merger, the Company assumed a sublease agreement for office and laboratory space located in Waltham, Massachusetts. The sublease commenced on January 15, 2019 and expired on November 30, 2020. The total minimum sublease rentals received under the Waltham, Massachusetts agreement was $0.6 million. In February 2019 and October 2018, the Company entered into two additional noncancelable operating leases for office space in Ann Arbor, Michigan for the Company’s headquarters; one that the Company took possession of in April 2019, and the other that the Company took possession of in July 2019, respectively. One of its leases in Ann Arbor, Michigan expires in June 2024 and the other expires in March 2024. In April 2019, the Company entered into a lease agreement for office space in Lexington, Massachusetts. This lease was scheduled to expire on September 30, 2020; however, in June 2020 the Company exercised its right to terminate the lease early such that the lease terminated on August 11, 2020. Lease agreements generally do not require material variable lease payments, residual value guarantees or restrictive covenants. In January 2020, the Company terminated its office lease agreement in Lyon, France. As of December 31, 2020, the operating lease ROU asset and the operating lease liabilities were $2.2 million and $2.4 million, respectively. The weighted average discount rate used to account for the Company's operating leases is the Company’s estimated incremental borrowing rate of 7.0%. The Company has options to extend certain of its leases for another five Rent expense related to the Company's operating leases was approximately $0.9 million and $0.7 million for the years ended December 31, 2020 and 2019, respectively. The Company recognizes rent expense on a straight-line basis over the lease period. Cash paid for amounts included in the measurement of the lease liabilities was approximately $1.8 million and $1.5 million during the years ended December 31, 2020 and 2019, respectively. The Company received approximately $0.3 million in sublease payments related to its Waltham, Massachusetts lease during each of the years ended December 31, 2020 and 2019. Future minimum rental payments under the Company’s noncancelable operating leases at December 31, 2020 is as follows (amounts in thousands): Year Ending December 31, 2021 $ 760 2022 783 2023 806 2024 302 2025 — Thereafter — Total $ 2,651 Present Value Adjustment (279) Lease liability at December 31, 2020 $ 2,372 Employment benefit plan The Company maintains a defined contribution 401(k) plan in which employees may contribute up to 100% of their salary and bonus, subject to statutory maximum contribution amounts. The Company contributes a safe harbor minimum contribution equivalent to 3% of employees’ compensation. The Company generally assumes all administrative costs of the plan. For the years ended December 31, 2020 and 2019, the expense relating to the contributions made was $0.2 million and $0.2 million, respectively. Litigation Liabilities for loss contingencies arising from claims, assessments, litigation, fines, penalties, and other sources are recorded when it is probable that a liability has been incurred and the amount can be reasonably estimated. On November 9, 2016, a purported shareholder derivative action was filed in the Business Litigation Session of the Suffolk County Superior Court in the Commonwealth of Massachusetts (Cima v. Dipp, No. 16-3443-BLS1 (Mass. Sup. Ct.)) against certain former officers and directors of OvaScience and one current director of the Company (a former director of OvaScience) and OvaScience as a nominal defendant alleging breach of fiduciary duties, unjust enrichment, abuse of control, gross mismanagement and waste of corporate assets for purported actions related to OvaScience’s January 2015 follow-on public offering. On February 22, 2017, the court approved the parties’ joint stipulation to stay all proceedings in the action until further notice. Following a status conference in December 2017, the stay was lifted. On January 25, 2018, at the parties’ request, the court entered a second order staying all proceedings in the action until further order of the court. On March 2, 2020, the parties submitted a status report requesting that the court continue the stay. On March 5, 2020, the court entered an order continuing the stay and requiring that the parties file a further status report on or before June 30, 2020. On June 30, 2020, the parties filed a further status report requesting that the court continue the stay. The court continued the stay until at least January 7, 2021. On January 7, 2021, the parties filed a further status report requesting that the court continue the stay until at least April 30, 2021. The case remains stayed until at least April 30, 2021, when the parties are due to file a further status report. The Company believes that the complaint is without merit and intends to defend against the litigation. There can be no assurance, however, that the Company will be successful. At present, the Company is unable to estimate potential losses, if any, related to the lawsuit. On March 24, 2017, a purported shareholder class action lawsuit was filed in the U.S. District Court for the District of Massachusetts (Dahhan v. OvaScience, Inc., No. 1:17-cv-10511-IT (D. Mass.)) against OvaScience and certain former officers of OvaScience alleging violations of Sections 10(b) and 20(a) of the Exchange Act (the “Dahhan Action”). On July 5, 2017, the court entered an order approving the appointment of Freedman Family Investments LLC as lead plaintiff, the firm of Robins Geller Rudman & Dowd LLP as lead counsel and the Law Office of Alan L. Kovacs as local counsel. Plaintiff filed an amended complaint on August 25, 2017. The Company filed a motion to dismiss the amended complaint, which the court denied on July 31, 2018. On August 14, 2018, the Company answered the amended complaint. On December 9, 2019, the court granted leave for the lead plaintiff to file a second amended complaint under seal and permitted the defendants to file a motion to strike the second amended complaint. On December 30, 2019, the court granted the parties’ joint motion to stay all proceedings in the case pending mediation. On March 3, 2020, the parties conducted a mediation session. The mediation was unsuccessful. The Company filed a motion to strike the second amended complaint on May 1, 2020. The Company believes that the amended complaint and the second amended complaint are without merit. On August 17, 2020, the court granted the parties’ joint motion to stay all proceedings in the case pending mediation. The parties agreed to participate in a second mediation session on November 10, 2020. On October 16, 2020, the court granted the parties’ joint request to extend the stay until November 16, 2020. On November 16, 2020, the parties filed a joint status report seeking to extend the stay for an additional thirty days. On November 17, 2020, the court ordered the parties to file a supplemental joint status report clarifying whether they sought a continuance of the stay of all proceedings or instead, a partial lifting of the stay. On November 19, 2020, the parties filed a joint status report seeking to continue a partial stay of the case while the parties engaged in additional settlement discussions, and a partial lifting of the stay to the extent required for the court to rule on the Company’s pending motion to strike and motions to dismiss filed by other defendants. Those motions remain pending. A resolution of this lawsuit adverse to the Company or the other defendants could have a material effect on the Company's consolidated financial position and results of operations. At present, the Company is unable to estimate potential losses, if any, related to the lawsuit. On July 27, 2017, a purported shareholder derivative complaint was filed in the U.S. District Court for the District of Massachusetts (Chiu v. Dipp, No. 1:17-cv-11382-IT (D. Mass.)) against OvaScience as a nominal defendant, certain former officers and directors of OvaScience and one current director of the Company (a former director of OvaScience) alleging breach of fiduciary duties, unjust enrichment and violations of Section 14(a) of the Exchange Act alleging that compensation awarded to the director defendants was excessive and seeking redress for purported actions related to OvaScience’s January 2015 follow-on public offering and other public statements concerning OvaScience’s AUGMENT treatment. On September 26, 2017, the plaintiff filed an amended complaint which eliminated all claims regarding allegedly excessive director pay and additionally alleged claims of abuse of control and waste of corporate assets. On October 27, 2017, the defendants filed a motion to dismiss the amended complaint. The court heard oral argument on the motion to dismiss on April 5, 2018. On April 13, 2018, the court granted the defendants’ motion to dismiss the amended complaint for failure to state a claim for relief under Section 14(a). The court also dismissed the plaintiffs’ pendent state law claims without prejudice, based on lack of subject matter jurisdiction. On April 25, 2018, the plaintiffs moved for leave to amend the complaint and to stay this case pending the outcome of the Dahhan Action. The Company does not believe that the proposed amended complaint cures the defects in the current complaint, but informed plaintiffs’ counsel that, in the interest of judicial economy, defendants would not oppose the proposed amendment if the court would consider staying the case pending the resolution of the Dahhan Action. On April 27, 2018, the court granted the plaintiffs’ motion for leave to amend the complaint and for a stay. On April 30, 2018, the plaintiffs filed their second amended complaint. On May 23, 2018, the court entered an order staying this case pending the resolution of the Dahhan Action. The Company believes that the complaint is without merit and intends to defend against the litigation. There can be no assurance, however, that the Company will be successful. At present, the Company is unable to estimate potential losses, if any, related to the lawsuit. In addition to the matters described above, the Company may be a party to litigation and subject to claims incident to the ordinary course of business from time to time. Regardless of the outcome, litigation can have an adverse impact on the Company because of defense and settlement costs, and diversion of management resources. |
Common Stock and Convertible Pr
Common Stock and Convertible Preferred Stock | 12 Months Ended |
Dec. 31, 2020 | |
Stockholders' Equity Note [Abstract] | |
Common Stock and Convertible Preferred Stock | Common Stock and Convertible Preferred Stock Common stock Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. Subject to preferences that may apply to any outstanding preferred stock, holders of common stock are entitled to receive ratably any dividends that the Company’s board of directors may declare out of funds legally available for that purpose on a non-cumulative basis. No dividends had been declared through December 31, 2020. Common stock warrants As of December 31, 2020, there were 17,125 common stock warrants outstanding with a weighted average exercise price of $16.93 per share. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation On June 11, 2019, the Company held its 2019 Annual Meeting of Stockholders (the “Annual Meeting”). At the Annual Meeting, the Company’s stockholders approved the Company’s 2019 Equity Incentive Plan (the “2019 Plan”) and the Company’s 2019 Employee Stock Purchase Plan (the “2019 ESPP,” and together with the 2019 Plan, the “Plans”). The 2019 Plan is the successor to the Private Millendo 2012 Stock Plan and the OvaScience 2012 Stock Incentive Plan (each, as amended, the “Prior Plans”) and allows the Company to grant stock options, restricted stock unit awards and other awards at levels determined appropriate by the Company’s Board of Directors (the “Board”) or the Compensation Committee of the Board. No additional awards will be granted under either of the Prior Plans. The 2019 ESPP enables employees to purchase shares of the Company’s common stock through offerings of rights to purchase the Company’s common stock to all eligible employees. The Plans were adopted by the Board on April 29, 2019, subject to approval by the Company’s stockholders, and became effective with such stockholder approval on June 11, 2019. Outstanding awards under the Prior Plans continue to be subject to the terms and conditions of the Prior Plans. The aggregate number of shares of the Company's common stock initially reserved for issuance under the 2019 Plan was 2,919,872 shares, which is the sum of (i) 534,320 shares, (ii) the number of unallocated shares remaining available for grant under the Prior Plans as of the effective date of the 2019 Plan, and (iii) the Prior Plans' Returning Shares (as defined below), as such shares become available from time to time. The number of shares of the Company's common stock reserved for issuance under the 2019 Plan will automatically increase on January 1 of each year, for a period of ten years, from January 1, 2020 continuing through January 1, 2029, by 4% of the total number of shares of the Company's common stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares as may be determined by the Board. Pursuant to the terms of the 2019 Plan, an additional 4% of the total number of shares of the Company's common stock outstanding on December 31, 2019 were added to the number of available shares effective January 1, 2020. The term "Prior Plans' Returning Shares" refers to the following shares of the Company's common stock subject to any outstanding stock award granted under either of the Prior Plans: shares of common stock subject to awards that (i) expire or terminate for any reason prior to exercise or settlement; (ii) are forfeited because of the failure to meet a contingency or condition required to vest such shares or otherwise return to the Company; or (iii) are reacquired, withheld (or not issued) to satisfy a tax withholding obligation in connection with an award or to satisfy the purchase price or exercise price of a stock award. The foregoing includes shares subject to outstanding awards under the OvaScience 2011 Stock Incentive Plan that expire, terminate or are otherwise surrendered, canceled, forfeited or repurchased by the Company at their original issuance price pursuant to a contractual repurchase right. The following shares of the Company's common stock (collectively, the "2019 Plan Returning Shares") will also become available again for issuance under the 2019 Plan: (i) any shares subject to a stock award that are not issued because such stock award expires or otherwise terminates without all of the shares covered by such stock award having been issued; (ii) any shares subject to a stock award that are not issued because such stock award is settled in cash; (iii) any shares issued pursuant to a stock award that are forfeited back to or repurchased by the Company because of the failure to meet a contingency or condition required for the vesting of such shares; and (iv) any shares reacquired by the Company in satisfaction of tax withholding obligations on a stock award or as consideration for the exercise or purchase price of a stock award. The aggregate number of shares of the Company's common stock that may be issued under the 2019 ESPP is 133,580 shares, plus the number of shares of the Company's common stock that are automatically added on January 1st of each year, for a period of up to ten years, from January 1, 2020 continuing through January 1, 2029, by 1% of the total number of shares of the Company's common stock outstanding on December 31 of the preceding calendar year, (ii) 133,580 shares of the Company's common stock, unless a lesser number of shares is determined by the Board. Pursuant to the terms of the 2019 Employee Stock Purchase Plan, an additional 133,580 shares were added to the number of available shares effective January 1, 2020. The Company measures employee and nonemployee stock-based awards at grant-date fair value and records compensation expense on a straight-line basis over the vesting period of the award. The Company recorded stock-based compensation expense in the following expense categories of its accompanying consolidated statements of operations and comprehensive loss for the years ended December 31, 2020 and 2019 (amounts in thousands): Year Ended 2020 2019 Research and development $ 977 $ 1,299 General and administrative 3,267 3,018 Total $ 4,244 $ 4,317 Stock options Options issued may have a contractual life of up to 10 years and may be exercisable in cash or as otherwise determined by the Board. Vesting generally occurs over a period of not greater than four years. In May 2020, the Company granted 840,450 stock options to its employees in connection with the PWS and CAH program changes that occurred during the second quarter of 2020 (see Note 1). The vesting was as follows: 1) 50 percent of the shares subject to this option grant will vest on the earlier of (i) December 31, 2020 or (ii) the Board's approval of the achievement of certain performance criteria, and 2) one twelfth (1/12th) of the remaining shares subject to this option grant will vest in equal monthly installments thereafter. The following table summarizes the activity related to stock option grants to employees and nonemployees for the years ended December 31, 2020 and 2019: Shares Weighted-average exercise price share Weighted-average remaining contractual life (years) Outstanding at January 1, 2019 1,764,287 $ 26.81 8.0 Granted 1,225,901 9.73 Exercised (97,225) 3.71 Forfeited (394,357) 40.42 Outstanding at December 31, 2019 2,498,606 17.18 7.7 Granted 1,864,375 4.71 Exercised (1,449) 1.08 Forfeited (612,430) 13.39 Outstanding at December 31, 2020 3,749,102 $ 11.60 7.9 Vested and exercisable at December 31, 2020 1,819,399 $ 16.34 6.8 Vested and expected to vest at December 31, 2020 3,749,102 $ 11.60 7.9 As of December 31, 2020, the unrecognized compensation cost related to 1,929,703 unvested stock options expected to vest was $8.1 million. This unrecognized compensation will be recognized over an estimated weighted-average amortization period of 2.3 years. The aggregate intrinsic value of options exercised during the year ended December 31, 2020 was $1,000. The aggregate intrinsic value of options exercised during the year ended December 31, 2019 was $0.7 million. The aggregate intrinsic value of options outstanding and options exercisable as of December 31, 2020 was $0.2 million and $0.1 million, respectively. The options granted during the years ended December 31, 2020 and 2019, had an estimated weighted average grant date fair value of $3.13 and $6.74, respectively. The fair value of options is estimated using the Black-Scholes option pricing model, which takes into account inputs such as the exercise price, the value of the underlying common stock at the grant date, expected term, expected volatility, risk-free interest rate and dividend yield. The fair value of each grant of options during the years ended December 31, 2020 and 2019 was determined using the methods and assumptions discussed below. • The expected term of employee options with service-based vesting is determined using the “simplified” method, as prescribed in SEC’s Staff Accounting Bulletin (“SAB”) No. 107, whereby the expected life equals the arithmetic average of the vesting term and the original contractual term of the option due to the Company’s lack of sufficient historical data. The expected term of nonemployee options is equal to the contractual term. • The expected volatility is based on historical volatilities of similar entities within the Company’s industry which were commensurate with the expected term assumption as described in SAB No. 107. • The risk-free interest rate is based on the interest rate payable on U.S. Treasury securities in effect at the time of grant for a period that is commensurate with the assumed expected term. • The expected dividend yield is 0% because the Company has not historically paid, and does not expect for the foreseeable future to pay, a dividend on its common stock. • Prior to the OvaScience Merger, the Company’s common stock was not publicly traded. The Company’s board of directors periodically estimated the fair value of the Company’s common stock considering, among other things, contemporaneous valuations of its common stock prepared by an unrelated third-party valuation firm in accordance with the guidance provided by the American Institute of Certified Public Accountants 2013 Practice Aid, Valuation of Privately-Held-Company Equity Securities Issued as Compensation. Following the OvaScience Merger, the fair market value of the Company’s common stock is determined based on the closing price of its common stock on the Nasdaq Capital Market. The grant date fair value of each option grant was estimated throughout the year using the Black-Scholes option-pricing model using the following assumptions for the Plan: Year Ended, Year Ended, 2020 2019 Expected term (in years) 5.74 6.02 Expected volatility 77 % 80 % Risk-free interest rate 0.86 % 2.22 % Expected dividend yield 0 % 0 % Fair market value of common stock $ 4.71 $ 9.73 At the time of the Alizé acquisition, Alizé had 6,219 non-employee (BSA) warrants and 5,360 employee (BSPCE) warrants outstanding, which have weighted-average exercise prices of €80.06 and €83.40, respectively. As of December 31, 2020, all BSAs and BSPCEs were vested. During the year ended December 31, 2020, 910 BSPCE warrants were exercised resulting in the issuance of 12,307 shares of the Company's common stock. In addition, during the year ended December 31, 2020, a total of 2,586 BSA and BSPCE warrants were forfeited. As of December 31, 2020, there were an aggregate of 48,265 shares of common stock issuable upon the exercise of the warrants with a weighted-average exercise price of $7.85 per share. These instruments are included in the equity attributable to noncontrolling interests. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes As of December 31, 2020, the Company had approximately $330.8 million and $280.9 million of federal and state net operating loss carryforwards, respectively, which begin to expire in 2031. As of December 31, 2020, the Company had approximately $5.3 million and $1.1 million of federal and state research and development tax credit carryforwards, respectively, that begin to expire in 2031 and 2029, respectively. As of December 31, 2020, the Company had approximately $7.4 million of federal orphan drug tax credit carryforwards that begin to expire in 2032. As of December 31, 2020, the Company had foreign net operating loss carryforwards of approximately $20.7 million which can be carried forward indefinitely. Section 382 of the Internal Revenue Code of 1986, as amended (the “Code”) provides for limitation on the use of net operating loss and research and development tax credit carryforwards following certain ownership changes (as defined in Code) that could limit the Company's ability to utilize these carryforwards. Pursuant to Section 382 of the Code, an ownership change occurs when the stock ownership of a 5% stockholder increases by more than 50% over a three-year testing period. The Company may have experienced various ownership changes, as defined by the Code, as a result of past financing and may in the future experience an ownership change. Accordingly, the Company's ability to utilize the aforementioned carryforwards may be limited. Additionally, U.S. tax laws limit the time during which these carryforwards may be applied against future taxes. The components of the net deferred income tax asset as of December 31, 2020 and 2019 are as follows (amounts in thousands): December 31, 2020 2019 Deferred taxes: Net operating loss carryforwards $ 90,842 $ 96,378 Research and development credit carryforwards 13,603 13,404 Stock-based compensation 4,071 4,107 Accruals 352 414 Right-of-use asset (508) (742) Lease liability 559 934 Capitalized start-up costs 775 855 Other 20 10 Gross deferred tax asset 109,714 115,360 Less: valuation allowance (109,714) (115,360) Net deferred tax asset $ — $ — In assessing the realizability of deferred tax assets, the Company considers whether it is more-likely-than-not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which the temporary differences representing net future deductible amounts become deductible. After consideration of all the evidence, both positive and negative, the Company has recorded a full valuation allowance against its net deferred tax assets as of December 31, 2020 because the Company has determined that is it more likely than not that these assets will not be fully realized due to historic net operating losses incurred. The valuation allowance decreased by $5.6 million during the year ended December 31, 2020, primarily due to the write-off of net operating loss carryforwards related to a wholly owned foreign subsidiary that filed for liquidation during the year ended December 31, 2020, offset by the generation of net operating losses and credit carryforwards during 2020. In addition to the deferred taxes listed in the above table, an income tax reduction of $83.4 million (tax-effected $19.5 million deferred tax asset with a full valuation allowance) resulting from the foreign subsidiary liquidation may be available as capital loss carryforwards, net operating loss carryforwards or a combination of both in the U.S., however, a detailed analysis of these losses is required to make this determination and has not yet been initiated. On December 31, 2020 and 2019, the Company had no unrecognized tax benefits. The Company’s policy is to record interest and penalties related to income taxes as a component of income tax expense. As of December 31, 2020 and 2019, the Company had no accrued interest or penalties related to income taxes and no amounts have been recognized in the Company’s statement of operations. A reconciliation of income tax expense (benefit) at the statutory federal income tax rate and income taxes as reflected in the financial statements is as follows: December 31, 2020 2019 Federal income tax benefit at statutory rate 21.0 % 21.0 % State income tax, net of federal benefit 2.2 % 2.4 % Permanent differences (2.4) % (1.0) % Rate change — % (8.7) % Research and development credit benefit 1.7 % 2.7 % Change in valuation allowance (22.5) % (16.4) % Effective income tax rate — % — % |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2020 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Related Party TransactionsAs discussed in Note 1, the Company sold shares of its common stock in December 2019. Roche invested in the Company's December 2019 financing. One of the Company's Board members is affiliated with Roche. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events Following an extensive process of evaluating strategic alternatives and identifying and reviewing potential candidates for a strategic acquisition or other transaction, on March 29, 2021, the Company entered into a Merger Agreement with Tempest. If the Merger is completed, the business of Tempest will continue as the business of the combined organization. At the closing of the Merger, (a) each then outstanding share of Tempest common stock (including shares of Tempest common stock issued upon conversion of Tempest preferred stock and shares of Tempest common stock issued in the financing transaction described in the Merger Agreement) will be converted into the right to receive a number of shares of Millendo common stock (subject to the payment of cash in lieu of fractional shares and after giving effect to a reverse stock split of Millendo common stock) calculated in accordance with the Merger Agreement and (b) each then outstanding Tempest stock option and warrant to purchase Tempest common stock will be assumed by Millendo, subject to adjustment as set forth in the Merger Agreement. The Merger Agreement contains certain termination rights of each of Millendo and Tempest, including, subject to compliance with the applicable terms of the Merger Agreement, the right of each party to terminate the Merger Agreement to enter into a definitive agreement for a superior proposal. Upon termination of the Merger Agreement under specified circumstances, Millendo may be required to pay Tempest a termination fee of $1.4 million or reimburse Tempest’s expenses up to a maximum of $1.0 million and Tempest may be required to pay Millendo a termination fee of $2.8 million or reimburse Millendo’s expenses up to a maximum of $1.0 million. |
Basis of Presentation and Sum_2
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Basis of presentation and consolidation principles | Basis of presentation and consolidation principles The accompanying Consolidated Financial Statements include the accounts of Millendo Therapeutics, Inc. and its subsidiaries, and all intercompany amounts have been eliminated. The Consolidated Financial Statements have been prepared in conformity with U.S. generally accepted accounting principles (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). The Consolidated Financial Statements include the accounts of the Company’s subsidiaries in which the Company holds a controlling financial interest as of the financial statement date. |
Use of estimates | Use of estimates The preparation of the Consolidated Financial Statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Due to the uncertainty of factors surrounding the estimates or judgments used in the preparation of the Consolidated Financial Statements, actual results may materially vary from these estimates. Estimates and assumptions are periodically reviewed and the effects of revisions are reflected in the financial statements in the period they are determined to be necessary. |
Significant Risks And Uncertainties Policy | Significant Risks and Uncertainties With the global spread of the ongoing COVID-19 pandemic in 2020, the Company has implemented business continuity plans designed to address and mitigate the impact of the COVID-19 pandemic on its business. The Company anticipates that the COVID-19 pandemic will continue to have an impact on clinical and preclinical development activities. The extent to which the COVID-19 pandemic impacts the Company’s business, its preclinical and clinical development and regulatory efforts, its corporate development objectives and the value of and market for its common stock, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the U.S., Europe and other countries, and the effectiveness of actions taken globally to contain and treat the disease. The global economic slowdown, the overall disruption of global healthcare systems and the other risks and uncertainties associated with the pandemic could have a material adverse effect on the Company’s business, financial condition, results of operations and growth prospects. In addition, the Company is subject to other challenges and risks specific to its business and its ability to execute on its strategy, as well as risks and uncertainties common to companies in the pharmaceutical industry with development operations, including, without limitation, risks and uncertainties associated with: obtaining regulatory approval of its product candidates, loss of single source suppliers or failure to comply with manufacturing regulations, identifying, acquiring or in-licensing additional products or product candidates; pharmaceutical product development and the inherent uncertainty of clinical success; and the challenges of protecting and enhancing its intellectual property rights; complying with applicable regulatory requirements. In addition, to the extent the ongoing COVID-19 pandemic adversely affects its business and results of operations, the Company may also have the effect of heightening many of the other risks and uncertainties discussed above. |
Concentration of credit risk | Concentration of credit risk Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash, cash equivalents and restricted cash. The Company generally invests its cash in deposits with high credit quality financial institutions. Deposits at banks may exceed the insurance provided on such deposits. Additionally, the Company performs periodic evaluations of the relative credit standing of these financial institutions. |
Cash and cash equivalents | Cash and cash equivalents The Company considers all highly liquid investments that have maturities of three months or less when acquired to be cash equivalents. Cash equivalents as of December 31, 2020 and 2019 consisted of money market funds. |
Restricted cash | Restricted cashRestricted cash relates to amounts used to secure the Company’s credit card facility balances held on deposit with major financial institutions, to collateralize a letter of credit in the name of the Company’s landlord pursuant to a certain operating lease agreement, and to fund an escrow arrangement in connection with a sublease agreement also pursuant to that same operating lease agreement. The escrow agreement ended in connection with the expiration of the Company's Waltham, Massachusetts lease agreement in November 2020 (see Note 7). |
Refundable tax credit | Refundable tax credit The Company earns French research tax credits (crédit d’impôt recherche) or (“CIR”) in connection with its research efforts through its wholly owned subsidiary in Lyon, France. CIR earned are refundable or they can offset French corporate income tax due. Since the French research tax credit can be recovered in cash, the Company has elected to treat this as a grant. During the year ended December 31, 2020 and 2019, the Company recognized a reduction of research and development expenses of $0.5 million and $1.2 million, respectively, and had a research tax credit receivable of $0.3 million and $1.3 million at December 31, 2020 and 2019, respectively. |
Leases | Leases The Company determines if an arrangement is a lease at contract inception. A lease exists when a contract conveys to the customer the right to control the use of identified property, plant, or equipment for a period of time in exchange for consideration. The definition of a lease embodies two conditions: (1) there is an identified asset in the contract that is land or a depreciable asset (i.e., property, plant, and equipment), and (2) the customer has the right to control the use of the identified asset. The lease liabilities are initially and subsequently measured at the present value of the unpaid lease payments at the lease commencement date. When readily determinable, the Company uses the implicit rate in determining the present value of lease payments. When leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the lease commencement date, including the lease term. The ROU asset is initially measured at cost, which comprises the initial amount of the lease liability adjusted for lease payments made at or before the lease commencement date, plus any initial direct costs incurred less any lease incentives received. For operating leases, the ROU asset is subsequently measured throughout the lease term at the carrying amount of the lease liability, plus initial direct costs, plus (minus) any prepaid (accrued) lease payments, less the unamortized balance of lease incentives received. Lease expense for lease payments is recognized on a straight-line basis over the lease term. Refer to Note 7 for further details. |
Fair value of financial instruments | Fair value of financial instruments Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: • Level 1—Quoted prices in active markets for identical assets or liabilities. • Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. • Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The asset’s or liability’s fair value measurement level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. The carrying value of the Company’s debt approximates fair value as of December 31, 2020 and 2019. |
Other assets | Other assets Other assets includes property and equipment and other assets. Property and equipment, less accumulated depreciation, are recorded at cost and are depreciated on a straight-line basis over their estimated useful lives which range from three |
Research and development expenses | Research and development expenses Research and development costs are expensed as incurred and consist primarily of personnel expenses, costs of funding research performed by third-parties, expenses incurred under agreements with contract manufacturing organizations, payments under third-party licensing agreements, consultant fees and expenses associated with outsourced professional scientific development services, expenses related to regulatory activities and allocated expense for facility costs. Milestone payment obligations incurred prior to regulatory approval of the product, which are accrued when the event requiring payment of the milestone occurs, are included in research and development expenses. Upfront milestone payments made to third-parties who perform research and development services on the Company’s behalf are expensed as services are rendered. At the end of each reporting period, the Company compares payments made to third-party service providers to the estimated progress toward completion of the applicable research or development objectives. Such estimates are subject to change as additional information becomes available. Depending on the timing of payments to the service providers and the progress that the Company estimates has been made as a result of the service provided, the Company may record net prepaid or accrued expense relating to these costs. As of December 31, 2020 and 2019, the Company has not made any material adjustments to its prior estimates of accrued research and development expenses. |
Stock based compensation | Stock-based compensation The Company measures and recognizes compensation expense for all stock options awarded to employees and nonemployees based on the estimated fair market value of the award on the grant date. The Company uses the Black-Scholes option pricing model to value its stock option awards. The Company recognizes compensation expense on a straight-line basis over the requisite service period, which is generally the vesting period of the award. The Company accounts for forfeitures of stock options as they occur. Estimating the fair market value of options requires the input of subjective assumptions, including the estimated fair value of the Company’s common stock, the expected life of the options, stock price volatility, the risk-free interest rate and expected dividends. The assumptions used in the Company’s Black-Scholes option-pricing model represent management’s best estimates and involve a number of variables, uncertainties and assumptions and the application of management’s judgment, as they are inherently subjective. |
Income taxes | Income taxes The Company recognizes deferred tax assets and liabilities for temporary differences between the financial reporting basis and the tax basis of the Company’s assets and liabilities and the expected benefits of net operating loss carryforwards. The impact of changes in tax rates and laws on deferred taxes, if any, applied during the period in which temporary differences are expected to be settled, is reflected in the Company’s financial statements in the period of enactment. The measurement of deferred tax assets is reduced, if necessary, if, based on weight of the evidence, it is more likely than not that some, or all, of the deferred tax assets will not be realized. As of December 31, 2020 and 2019, the Company has concluded that a full valuation allowance is necessary for all of its net deferred tax assets. The Company had no material amounts recorded for uncertain tax positions, interest or penalties in the accompanying Consolidated Financial Statements. |
Net loss per share | Net loss per share Basic loss per share of common stock is computed by dividing net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during each period. Diluted loss per share of common stock includes the effect, if any, from the potential exercise or conversion of securities, such as restricted stock, and stock options, which would result in the issuance of incremental shares of common stock. In computing the basic and diluted net loss per share, the weighted-average number of shares of common stock remains the same for both calculations due to the fact that when a net loss exists, dilutive shares are not included in the calculation as the impact is anti-dilutive. |
Segment information | Segment information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one segment. |
Foreign currency | Foreign currency Results of foreign operations are translated from their functional currency into U.S. dollars (reporting currency) using average exchange rates in effect during the year, while assets and liabilities are translated into U.S. dollars using exchange rates in effect at the balance sheet date. The resulting translation adjustments are recorded in accumulated other comprehensive loss. Transaction gains and losses resulting from exchange rate changes on transactions denominated in currencies other than the functional currency are included in income in the period in which the change occurs and reported within other expenses in the consolidated statements of operations and comprehensive loss. |
Recent accounting pronouncements | Recent accounting pronouncements In January 2020, the FASB issued ASU 2020-01, Investments-Equity Securities (Topic 321), Investments-Equity Method and Joint Ventures (Topic 323), and Derivatives and Hedging (Topic 815). ASU 2020-01 states any equity security transitioning from the alternative method of accounting under Topic 321 to the equity method, or vice versa, due to an observable transaction will be remeasured immediately before the transition. In addition, the ASU clarifies the accounting for certain non-derivative forward contracts or purchased call options to acquire equity securities stating such instruments will be measured using the fair value principles of Topic 321 before settlement or exercise. The ASU is effective for fiscal years beginning after December 15, 2020, and will be applied on a prospective basis. Early adoption is permitted. The Company adopted ASU 2020-01 on January 1, 2021, which did not have a material effect on the consolidated financial statements. In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740) - Simplifying the Accounting for Income Taxes. ASU 2019-12 simplifies the accounting for income taxes by removing exceptions within the general principles of Topic 740 regarding the calculation of deferred tax liabilities, the incremental approach for intraperiod tax allocation, and calculating income taxes in an interim period. In addition, the ASU adds clarifications to the accounting for franchise tax (or similar tax), which is partially based on income, evaluating tax basis of goodwill recognized from a business combination, and reflecting the effect of any enacted changes in tax laws or rates in the annual effective tax rate computation in the interim period that includes the enactment date. The ASU is effective for fiscal years beginning after December 15, 2020, and will be applied either retrospectively or prospectively based upon the applicable amendments. Early adoption is permitted. The Company adopted ASU 2019-01 on January 1, 2021, which did not have a material effect on the consolidated financial statements. In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820) Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement . ASU 2018-13 resulted in certain modifications to fair value measurement disclosures, primarily related to level 3 fair value measurements. The standard was effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019, and early adoption was permitted. The adoption of ASU 2018-13 did not have a material impact on the Company's consolidated financial statements and related disclosures. In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326) Measurement of Credit Losses on Financial Instruments , which replaces the incurred loss impairment methodology in current GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. Additionally, ASU 2016-13 requires a financial asset measured at amortized cost basis to be presented at the net amount expected to be collected through the use of an allowance of expected credit losses. In May 2019, the FASB issued ASU 2019-05, Financial Instruments - Credit Losses (Topic 326) Targeted Transition Relief , which amends ASU 2016-13 by providing entities with an option to irrevocably elect the fair value option to be applied on an instrument-by-instrument basis for eligible financial instruments that are within the scope of Topic 326. The fair value option election does not apply to held-to-maturity debt securities. In November 2019, the FASB issued ASU 2019-10, Financial Instruments - Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842) , which finalized effective date delays for private companies, not-for-profit organizations, and certain smaller reporting companies applying the credit losses, leases, and hedging standards. Also in November 2019, the FASB issued ASU 2019-11, Codification Improvements to Topic 326, Financial Instruments - Credit Losses , which provides clarity about certain aspects of the amendments in ASU 2016-13. ASU 2016-13, as amended, is effective for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years, and requires a modified retrospective approach. The Company is in the process of evaluating the impact of this new guidance on its consolidated financial statements and related disclosures. |
Subsequent events | Subsequent events Subsequent events were evaluated through the filing date of this Annual Report. |
Basis of Presentation and Sum_3
Basis of Presentation and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Schedule of reconciliation of the components of cash, cash equivalents, and restricted cash | The following table provides a reconciliation of the components of cash, cash equivalents, and restricted cash reported in the Company's consolidated balance sheets to the total of the amount presented in the Consolidated Statements of Cash Flows: December 31, 2020 2019 (in thousands) Cash and cash equivalents $ 38,174 $ 62,478 Restricted cash 484 1,034 Total cash, cash equivalents, and restricted cash shown in the Consolidated Statements of Cash Flows $ 38,658 $ 63,512 |
Schedule of potentially dilutive securities have been excluded from the computation of diluted weighted average shares of common stock outstanding | The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares of common stock outstanding, as they would be anti-dilutive (amounts shown as common stock equivalents): Year ended December 31, 2020 2019 Stock options 3,749,102 2,498,606 Common stock warrants 17,125 17,125 BSA and BSPCE warrants 48,265 95,567 3,814,492 2,611,298 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Schedule of assets and liabilities measured at fair value on a recurring basis | The following table presents the Company’s assets and liabilities that are measured at fair value on a recurring basis (amounts in thousands): December 31, 2020 (Level 1) (Level 2) (Level 3) Assets Money market funds (included in cash and cash equivalents) $ 33,636 $ — $ — December 31, 2019 (Level 1) (Level 2) (Level 3) Assets Money market funds (included in cash and cash equivalents) $ 59,382 $ — $ — |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Accrued Liabilities, Current [Abstract] | |
Schedule of accrued expenses | Accrued expenses consist of (amounts in thousands): December 31, 2020 2019 Compensation and related benefits $ 1,978 $ 2,042 Professional fees 719 2,929 Preclinical and clinical costs 1,002 1,820 Insurance premiums 1,476 1,423 Other 350 852 Total $ 5,525 $ 9,066 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of future minimum rental payments under company's noncancelable operating leases | Future minimum rental payments under the Company’s noncancelable operating leases at December 31, 2020 is as follows (amounts in thousands): Year Ending December 31, 2021 $ 760 2022 783 2023 806 2024 302 2025 — Thereafter — Total $ 2,651 Present Value Adjustment (279) Lease liability at December 31, 2020 $ 2,372 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of stock based compensation expense | The Company recorded stock-based compensation expense in the following expense categories of its accompanying consolidated statements of operations and comprehensive loss for the years ended December 31, 2020 and 2019 (amounts in thousands): Year Ended 2020 2019 Research and development $ 977 $ 1,299 General and administrative 3,267 3,018 Total $ 4,244 $ 4,317 |
Summary of the activity related to stock option grants to employees and nonemployees | The following table summarizes the activity related to stock option grants to employees and nonemployees for the years ended December 31, 2020 and 2019: Shares Weighted-average exercise price share Weighted-average remaining contractual life (years) Outstanding at January 1, 2019 1,764,287 $ 26.81 8.0 Granted 1,225,901 9.73 Exercised (97,225) 3.71 Forfeited (394,357) 40.42 Outstanding at December 31, 2019 2,498,606 17.18 7.7 Granted 1,864,375 4.71 Exercised (1,449) 1.08 Forfeited (612,430) 13.39 Outstanding at December 31, 2020 3,749,102 $ 11.60 7.9 Vested and exercisable at December 31, 2020 1,819,399 $ 16.34 6.8 Vested and expected to vest at December 31, 2020 3,749,102 $ 11.60 7.9 |
Summary of grant date fair value assumptions | The grant date fair value of each option grant was estimated throughout the year using the Black-Scholes option-pricing model using the following assumptions for the Plan: Year Ended, Year Ended, 2020 2019 Expected term (in years) 5.74 6.02 Expected volatility 77 % 80 % Risk-free interest rate 0.86 % 2.22 % Expected dividend yield 0 % 0 % Fair market value of common stock $ 4.71 $ 9.73 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Schedule of components of the net deferred income tax asset | The components of the net deferred income tax asset as of December 31, 2020 and 2019 are as follows (amounts in thousands): December 31, 2020 2019 Deferred taxes: Net operating loss carryforwards $ 90,842 $ 96,378 Research and development credit carryforwards 13,603 13,404 Stock-based compensation 4,071 4,107 Accruals 352 414 Right-of-use asset (508) (742) Lease liability 559 934 Capitalized start-up costs 775 855 Other 20 10 Gross deferred tax asset 109,714 115,360 Less: valuation allowance (109,714) (115,360) Net deferred tax asset $ — $ — |
Schedule of reconciliation of income tax expense (benefit) at the statutory federal income tax rate | A reconciliation of income tax expense (benefit) at the statutory federal income tax rate and income taxes as reflected in the financial statements is as follows: December 31, 2020 2019 Federal income tax benefit at statutory rate 21.0 % 21.0 % State income tax, net of federal benefit 2.2 % 2.4 % Permanent differences (2.4) % (1.0) % Rate change — % (8.7) % Research and development credit benefit 1.7 % 2.7 % Change in valuation allowance (22.5) % (16.4) % Effective income tax rate — % — % |
Organization and Description _2
Organization and Description of Business (Details) - USD ($) | Mar. 11, 2020 | Jan. 31, 2021 | Dec. 31, 2019 | Apr. 30, 2019 | Jun. 30, 2020 | Dec. 31, 2020 |
Subsidiary, Sale of Stock [Line Items] | ||||||
Cash, cash equivalents, and marketable securities | $ 38,700,000 | |||||
Accumulated deficit | $ 208,654,000 | $ 245,060,000 | ||||
Underwriting Agreement | ||||||
Subsidiary, Sale of Stock [Line Items] | ||||||
Common shares sold (in shares) | 4,791,667 | |||||
Net proceeds from sale | $ 26,500,000 | |||||
Public Offering | ||||||
Subsidiary, Sale of Stock [Line Items] | ||||||
Common shares sold (in shares) | 4,166,667 | |||||
Net proceeds from sale | $ 23,000,000 | |||||
Price per share (in dollars per share) | $ 6 | |||||
Over-Allotment Option | ||||||
Subsidiary, Sale of Stock [Line Items] | ||||||
Common shares sold (in shares) | 625,000 | |||||
Net proceeds from sale | $ 3,500,000 | |||||
Price per share (in dollars per share) | $ 6 | |||||
At-the-market offering | ||||||
Subsidiary, Sale of Stock [Line Items] | ||||||
Common shares sold (in shares) | 719,400 | |||||
Net proceeds from sale | $ 5,500,000 | |||||
Aggregate offering value | $ 50,000,000 | |||||
Prader-Willi Syndrome Clinical Development Program Discontinuation | Employee Severance | ||||||
Subsidiary, Sale of Stock [Line Items] | ||||||
Employee positions eliminated, percent | 30.00% | |||||
Costs related to termination benefits | $ 1,100,000 | |||||
The Plan | Subsequent event | ||||||
Subsidiary, Sale of Stock [Line Items] | ||||||
Percent of positions eliminated, planned reduction | 85.00% | |||||
The Plan | Employee Retention Arrangements | Subsequent event | ||||||
Subsidiary, Sale of Stock [Line Items] | ||||||
Restructuring and related cost, expected cost | $ 5,500,000 | |||||
Livoletide Program | ||||||
Subsidiary, Sale of Stock [Line Items] | ||||||
Operating expenses | $ 3,100,000 |
Basis of Presentation and Sum_4
Basis of Presentation and Summary of Significant Accounting Policies - Reconciliation of Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Accounting Policies [Abstract] | |||
Cash and cash equivalents | $ 38,174 | $ 62,478 | |
Restricted cash | 484 | 1,034 | |
Total cash, cash equivalents, and restricted cash shown in the Consolidated Statements of Cash Flows | $ 38,658 | $ 63,512 | $ 73,770 |
Basis of Presentation and Sum_5
Basis of Presentation and Summary of Significant Accounting Policies - Narrative (Details) $ in Millions | 12 Months Ended | |
Dec. 31, 2020USD ($)segment | Dec. 31, 2019USD ($) | |
Property, Plant and Equipment [Line Items] | ||
Reduction of research and development expenses | $ 0.5 | $ 1.2 |
Research tax credit receivable | $ 0.3 | $ 1.3 |
Number of segments | segment | 1 | |
Minimum | ||
Property, Plant and Equipment [Line Items] | ||
Estimated useful life of property and equipment | 3 years | |
Maximum | ||
Property, Plant and Equipment [Line Items] | ||
Estimated useful life of property and equipment | 5 years |
Basis of Presentation and Sum_6
Basis of Presentation and Summary of Significant Accounting Policies - Net loss per share (Details) - shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Potentially dilutive securities have been excluded from the computation of diluted weighted average shares of common stock outstanding | ||
Securities have been excluded from the computation of diluted weighted average shares of common stock outstanding (in shares) | 3,814,492 | 2,611,298 |
Stock options | ||
Potentially dilutive securities have been excluded from the computation of diluted weighted average shares of common stock outstanding | ||
Securities have been excluded from the computation of diluted weighted average shares of common stock outstanding (in shares) | 3,749,102 | 2,498,606 |
Common stock warrants | ||
Potentially dilutive securities have been excluded from the computation of diluted weighted average shares of common stock outstanding | ||
Securities have been excluded from the computation of diluted weighted average shares of common stock outstanding (in shares) | 17,125 | 17,125 |
BSA and BSPCE warrants | ||
Potentially dilutive securities have been excluded from the computation of diluted weighted average shares of common stock outstanding | ||
Securities have been excluded from the computation of diluted weighted average shares of common stock outstanding (in shares) | 48,265 | 95,567 |
Fair Value Measurements - Recur
Fair Value Measurements - Recurring basis (Details) - Recurring - Money market funds - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Level 1 | ||
Assets | ||
Money market funds (included in cash and cash equivalents) | $ 33,636 | $ 59,382 |
Level 2 | ||
Assets | ||
Money market funds (included in cash and cash equivalents) | 0 | 0 |
Level 3 | ||
Assets | ||
Money market funds (included in cash and cash equivalents) | $ 0 | $ 0 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Accrued Liabilities, Current [Abstract] | ||
Compensation and related benefits | $ 1,978 | $ 2,042 |
Professional fees | 719 | 2,929 |
Preclinical and clinical costs | 1,002 | 1,820 |
Insurance premiums | 1,476 | 1,423 |
Other | 350 | 852 |
Total | $ 5,525 | $ 9,066 |
Debt - Bpifrance Reimbursable A
Debt - Bpifrance Reimbursable Advance (Details) | 1 Months Ended | 12 Months Ended | |||||
Apr. 30, 2020 | Dec. 31, 2017USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2020EUR (€) | Dec. 31, 2019USD ($) | Dec. 31, 2020EUR (€) | Dec. 31, 2017EUR (€) | |
Debt | |||||||
Reimbursement annuity (percent) | 20.00% | 20.00% | |||||
Repayment of debt | $ | $ 108,000 | $ 184,000 | |||||
Bpifrance | |||||||
Debt | |||||||
Principal payment deferral period | 6 months | ||||||
Alize | Bpifrance | |||||||
Debt | |||||||
Debt assumed | € | € 700,000 | ||||||
Original advance amount | € | € 800,000 | ||||||
Interest charged under the advance | $ | $ 0 | ||||||
Interest accrued under the advance | $ | $ 0 | ||||||
Quarterly principal payments | € | € 17,500 | ||||||
Final principal payments | € | € 50,000 | ||||||
Repayment of debt | $ | 100,000 | $ 200,000 | |||||
Balance outstanding | $ 300,000 | € 200,000 |
License Agreements (Details)
License Agreements (Details) | 12 Months Ended | ||||
Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2020CAD ($) | Jun. 13, 2013USD ($) | |
UM License Agreement | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Payments upon the achievement of milestones | $ 2,500,000 | ||||
Expense in connection with achievement of certain milestones | $ 0 | $ 0 | |||
Expense paid to extend date of certain milestones | $ 100,000 | ||||
Annual royalty payments due in 2021 | $ 20,000 | ||||
Annual royalty payments due in 2022 | 20,000 | ||||
Annual royalty payments due in 2023 | 20,000 | ||||
Annual fee | $ 200,000 | ||||
Assignors | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Payments upon the achievement of milestones | $ 100,000 |
Commitments and Contingencies -
Commitments and Contingencies - Narrative (Details) $ in Thousands | 5 Months Ended | 12 Months Ended | ||
Feb. 28, 2019agreement | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Jan. 15, 2019USD ($) | |
Lessee, Lease, Description [Line Items] | ||||
Term of contract | 3 years 6 months | |||
Number of additional non-cancelable operating lease agreements | agreement | 2 | |||
Operating lease right-of-use assets | $ 2,157 | $ 3,331 | ||
Lease liability at December 31, 2020 | $ 2,372 | |||
Discount rate | 7.00% | |||
Operating lease, weighted average remaining lease term | 3 years 4 months 17 days | |||
Rent expense | $ 900 | 700 | ||
Cash paid for amount included in lease liabilities | 1,800 | 1,500 | ||
Sublease payment | $ 300 | 300 | ||
Employees contribution (as a percent) | 100.00% | |||
Safe harbor minimum contribution (as a percent) | 3.00% | |||
Expense relating to contributions | $ 200 | $ 200 | ||
Minimum | ||||
Lessee, Lease, Description [Line Items] | ||||
Lease renewal term | 5 years | |||
Maximum | ||||
Lessee, Lease, Description [Line Items] | ||||
Lease renewal term | 10 years | |||
Waltham, Massachusetts | ||||
Lessee, Lease, Description [Line Items] | ||||
Minimum rental receivable | $ 600 |
Commitments and Contingencies_2
Commitments and Contingencies - Future minimum rental payments under operating leases with noncancelable terms (Details) $ in Thousands | Dec. 31, 2020USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2021 | $ 760 |
2022 | 783 |
2023 | 806 |
2024 | 302 |
2025 | 0 |
Thereafter | 0 |
Lease liability at December 31, 2020 | 2,651 |
Present Value Adjustment | (279) |
Lease liability at December 31, 2020 | $ 2,372 |
Common Stock and Convertible _2
Common Stock and Convertible Preferred Stock (Details) | 12 Months Ended |
Dec. 31, 2020vote$ / sharesshares | |
Stockholders' Equity Note [Abstract] | |
Number of votes per share | vote | 1 |
Dividend declared (in usd per share) | $ 0 |
Common stock warrants outstanding (in shares) | shares | 17,125 |
Exercise price of warrants (in usd per share) | $ 16.93 |
Stock-Based Compensation - Narr
Stock-Based Compensation - Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | |
May 31, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based compensation | |||
Vesting period (in years) | 4 years | ||
Contractual life (in years) | 10 years | ||
Granted (in shares) | 840,450 | 1,864,375 | 1,225,901 |
Unvested stock options (in shares) | 1,929,703 | ||
Unrecognized compensation cost | $ 8,100 | ||
Weighted average amortization period | 2 years 3 months 18 days | ||
Aggregate intrinsic value of options exercised | $ 1 | $ 700 | |
Aggregate intrinsic value of options outstanding | 200 | ||
Aggregate intrinsic value of options exercisable | $ 100 | ||
Weighted average grant date fair value, options granted (in dollars per share) | $ 3.13 | $ 6.74 | |
Expected dividend yield | 0.00% | 0.00% | |
Tranche One | |||
Share-based compensation | |||
Percentage of shares to vest | 50.00% | ||
Tranche Two | |||
Share-based compensation | |||
Percentage of shares to vest | 8.33% | ||
2019 Plan | |||
Share-based compensation | |||
Shares available for future issuance (in shares) | 2,919,872 | ||
New shares available for future issuance (in shares) | 534,320 | ||
Vesting period (in years) | 10 years | ||
Percentage of common stock outstanding | 4.00% | ||
ESPP | |||
Share-based compensation | |||
Vesting period (in years) | 10 years | ||
Percentage of common stock outstanding | 1.00% | ||
Aggregate number of shares issued (in shares) | 133,580 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock based compensation expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock based compensation expense | $ 4,244 | $ 4,317 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock based compensation expense | 977 | 1,299 |
General and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock based compensation expense | $ 3,267 | $ 3,018 |
Stock-Based Compensation - St_2
Stock-Based Compensation - Stock options (Details) - $ / shares | 1 Months Ended | 12 Months Ended | ||
May 31, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
The activity related to stock option grants to employees and nonemployees | ||||
Outstanding at beginning (in shares) | 2,498,606 | 1,764,287 | ||
Granted (in shares) | 840,450 | 1,864,375 | 1,225,901 | |
Exercised (in shares) | (1,449) | (97,225) | ||
Forfeited (in shares) | (612,430) | (394,357) | ||
Outstanding at end (in shares) | 3,749,102 | 2,498,606 | 1,764,287 | |
Vested and exercisable at end (in shares) | 1,819,399 | |||
Vested and expected to vest at end (in shares) | 3,749,102 | |||
Weighted-average exercise price share | ||||
Outstanding at beginning (in dollars per share) | $ 17.18 | $ 26.81 | ||
Granted (in dollars per share) | 4.71 | 9.73 | ||
Exercised (in dollars per share) | 1.08 | 3.71 | ||
Forfeited (in dollars per share) | 13.39 | 40.42 | ||
Outstanding at end (in dollars per share) | 11.60 | $ 17.18 | $ 26.81 | |
Vested and exercisable at end (in dollars per share) | 16.34 | |||
Vested and expected to vest at end (in dollars per share) | $ 11.60 | |||
Weighted-average remaining contractual life (years) | ||||
Outstanding (in years) | 7 years 10 months 24 days | 7 years 8 months 12 days | 8 years | |
Vested and exercisable at end (in years) | 6 years 9 months 18 days | |||
Vested and expected to vest at end (in years) | 7 years 10 months 24 days |
Stock-Based Compensation - Gran
Stock-Based Compensation - Grant date fair value of option (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract] | ||
Expected term (in years) | 5 years 8 months 26 days | 6 years 7 days |
Expected volatility | 77.00% | 80.00% |
Risk-free interest rate | 0.86% | 2.22% |
Expected dividend yield | 0.00% | 0.00% |
Fair market value of common stock (in dollars per share) | $ 4.71 | $ 9.73 |
Stock-Based Compensation - Aliz
Stock-Based Compensation - Alizé Acquisition Narrative (Details) | 12 Months Ended | ||
Dec. 31, 2020$ / sharesshares | Dec. 31, 2019shares | Dec. 19, 2017€ / sharesshares | |
Class of Warrant or Right [Line Items] | |||
Common stock warrants outstanding (in shares) | 17,125 | ||
Exercise price of warrants (in usd/euros per share) | $ / shares | $ 16.93 | ||
BSPCE warrants | |||
Class of Warrant or Right [Line Items] | |||
Warrant exercised (in shares) | 910 | ||
Common Stock | |||
Class of Warrant or Right [Line Items] | |||
Exercise/forfeiture of BSPCE warrants (in shares) | 12,307 | 17,713 | |
Alize | |||
Class of Warrant or Right [Line Items] | |||
Exercise price of warrants (in usd/euros per share) | $ / shares | $ 7.85 | ||
Number of shares issuable upon the exercise of the warrants (in shares) | 48,265 | ||
Alize | Warrant | BSA warrants | |||
Class of Warrant or Right [Line Items] | |||
Common stock warrants outstanding (in shares) | 6,219 | ||
Exercise price of warrants (in usd/euros per share) | € / shares | € 80.06 | ||
Alize | Warrant | BSPCE warrants | |||
Class of Warrant or Right [Line Items] | |||
Common stock warrants outstanding (in shares) | 5,360 | ||
Exercise price of warrants (in usd/euros per share) | € / shares | € 83.40 | ||
Alize | Warrant | Bsa And Bscpce Warrants | |||
Class of Warrant or Right [Line Items] | |||
Number of securities forfeited (in shares) | 2,586 | ||
Alize | Common Stock | BSPCE warrants | |||
Class of Warrant or Right [Line Items] | |||
Exercise/forfeiture of BSPCE warrants (in shares) | 12,307 |
Income Taxes (Details)
Income Taxes (Details) $ in Millions | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Operating Loss Carryforwards [Line Items] | |
Increase in valuation allowance | $ 5.6 |
Deferred tax assets, foreign subsidiary liquidation | 83.4 |
Deferred tax assets, foreign subsidiary liquidation, tax-effected | 19.5 |
Federal | |
Operating Loss Carryforwards [Line Items] | |
Net operating loss carryforwards | 330.8 |
Research tax credit carryforwards | 5.3 |
Federal | Orphan Drug Tax Credit Carryforward | |
Operating Loss Carryforwards [Line Items] | |
Research tax credit carryforwards | 7.4 |
Foreign | |
Operating Loss Carryforwards [Line Items] | |
Net operating loss carryforwards | 20.7 |
State | |
Operating Loss Carryforwards [Line Items] | |
Net operating loss carryforwards | 280.9 |
Research tax credit carryforwards | $ 1.1 |
Income Taxes - Net deferred inc
Income Taxes - Net deferred income tax asset (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Deferred taxes: | ||
Net operating loss carryforwards | $ 90,842 | $ 96,378 |
Research and development credit carryforwards | 13,603 | 13,404 |
Stock-based compensation | 4,071 | 4,107 |
Accruals | 352 | 414 |
Right-of-use asset | (508) | (742) |
Lease liability | 559 | 934 |
Capitalized start-up costs | 775 | 855 |
Other | 20 | 10 |
Gross deferred tax asset | 109,714 | 115,360 |
Less: valuation allowance | (109,714) | (115,360) |
Net deferred tax asset | $ 0 | $ 0 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of income tax expense (benefit) (Details) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Reconciliation of income tax expense (benefit) at the statutory federal income tax rate | ||
Federal income tax benefit at statutory rate | 21.00% | 21.00% |
State income tax, net of federal benefit | 2.20% | 2.40% |
Permanent differences | (2.40%) | (1.00%) |
Rate change | 0.00% | (8.70%) |
Research and development credit benefit | 1.70% | 2.70% |
Change in valuation allowance | (22.50%) | (16.40%) |
Effective income tax rate | 0.00% | 0.00% |
Subsequent Events (Details)
Subsequent Events (Details) - Subsequent event - Millendo Therapeutics, Inc. - Tempest $ in Thousands | Mar. 29, 2021USD ($) |
Subsequent Event [Line Items] | |
Business combination, termination, fee payable upon termination | $ 1,400 |
Business combination, termination, expense reimbursement payable, maximum | 1,000 |
Business combination, termination, fee receivable upon termination | 2,800 |
Business combination, termination, expense reimbursement receivable, maximum | $ 1,000 |