Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2020 | May 07, 2020 | |
Document And Entity Information | ||
Entity Registrant Name | Millendo Therapeutics, Inc. | |
Entity Central Index Key | 0001544227 | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2020 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 13,472,937 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q1 | |
Document Quarterly Report | true | |
Document Transition Report | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 58,007 | $ 62,478 |
Short-term restricted cash | 870 | 1,034 |
Prepaid expenses and other current assets | 4,211 | 6,344 |
Refundable tax credit | 1,536 | 1,276 |
Total current assets | 64,624 | 71,132 |
Operating lease right-of-use assets | 2,866 | 3,331 |
Other assets | 555 | 507 |
Total assets | 68,045 | 74,970 |
Current liabilities: | ||
Current portion of debt | 258 | 208 |
Accounts payable | 2,773 | 1,495 |
Accrued expenses | 6,738 | 9,066 |
Operating lease liabilities — current | 1,442 | 1,751 |
Total current liabilities | 11,211 | 12,520 |
Debt, net of current portion | 110 | 168 |
Operating lease liabilities | 2,078 | 2,395 |
Other liabilities | 7 | 16 |
Total liabilities | 13,406 | 15,099 |
Commitments and contingencies (Note 6) | ||
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; 18,998,252 and 18,266,545 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively | 19 | 18 |
Additional paid-in capital | 274,340 | 267,018 |
Accumulated deficit | (220,652) | (208,654) |
Accumulated other comprehensive income | 123 | 165 |
Total stockholders’ equity attributable to Millendo Therapeutics, Inc. | 53,830 | 58,547 |
Equity attributable to noncontrolling interests | 809 | 1,324 |
Total stockholders’ equity | 54,639 | 59,871 |
Total liabilities and stockholders’ equity | $ 68,045 | $ 74,970 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2020 | Dec. 31, 2019 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in shares) | $ 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 shares) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 100,000,000 | 100,000,000 |
Common stock, shares issued (in shares) | 18,998,252 | 18,266,545 |
Common stock, shares outstanding (in shares) | 18,998,252 | 18,266,545 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Operating expenses: | ||
Research and development | $ 7,540 | $ 6,204 |
General and administrative | 4,595 | 4,453 |
Loss from operations | 12,135 | 10,657 |
Other expenses: | ||
Interest expense (income), net | (162) | (315) |
Other loss | 25 | 24 |
Net loss | $ (11,998) | $ (10,366) |
Net loss per share of common stock, basic and diluted (in USD per share) | $ (0.65) | $ (0.78) |
Weighted-average shares of common stock outstanding, basic and diluted (in shares) | 18,448,507 | 13,357,999 |
Other comprehensive income (loss): | ||
Foreign currency translation adjustment | $ (42) | $ (9) |
Comprehensive loss | $ (12,040) | $ (10,375) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders’ Equity (Deficit) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Income | Total Stockholders’ Equity (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 |
Stock-based compensation expense | 939 | 939 | 939 | ||||
Foreign currency translation adjustment | (9) | (9) | (9) | ||||
Net income (loss) | (10,366) | (10,366) | (10,366) | ||||
Balance at end (in shares) at Mar. 31, 2019 | 13,357,999 | ||||||
Balance at end at Mar. 31, 2019 | 63,686 | $ 13 | 235,815 | (174,452) | 139 | 61,515 | 2,171 |
Balance at beginning (in shares) at Dec. 31, 2019 | 18,266,545 | ||||||
Balance at beginning at Dec. 31, 2019 | 59,871 | $ 18 | 267,018 | (208,654) | 165 | 58,547 | 1,324 |
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 | 593 | 593 | (515) | |||
Stock-based compensation expense | 1,080 | 1,080 | 1,080 | ||||
Foreign currency translation adjustment | (42) | (42) | (42) | ||||
Net income (loss) | (11,998) | (11,998) | (11,998) | ||||
Balance at end (in shares) at Mar. 31, 2020 | 18,998,252 | ||||||
Balance at end at Mar. 31, 2020 | $ 54,639 | $ 19 | $ 274,340 | $ (220,652) | $ 123 | $ 53,830 | $ 809 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Operating activities: | ||
Net loss | $ (11,998) | $ (10,366) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 37 | 8 |
Stock-based compensation expense | 1,080 | 939 |
Amortization of right-of-use asset | 243 | 76 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 1,807 | (162) |
Other assets | (1) | (59) |
Accounts payable | 1,329 | 398 |
Accrued expenses and other liabilities | (2,255) | (1,291) |
Operating lease liabilities | (403) | (144) |
Cash used in operating activities | (10,161) | (10,601) |
Investing activities: | ||
Purchase of property and equipment | (26) | (10) |
Proceeds from sale of marketable securities | 0 | 2,986 |
Cash (used in) provided by investing activities | (26) | 2,976 |
Financing activities: | ||
Repayment of debt | 0 | (45) |
Payment of financing costs | (197) | (15) |
Proceeds from the issuance of common stock, net of issuance costs | 5,718 | 0 |
Proceeds from option and warrant exercises | 78 | 0 |
Repayment of principal on finance lease | (10) | 0 |
Cash provided by (used in) financing activities | 5,589 | (60) |
Effect of foreign currency exchange rate changes on cash | (37) | (14) |
Net decrease in cash, cash equivalents and restricted cash | (4,635) | (7,699) |
Cash, cash equivalents and restricted cash at beginning of period | 63,512 | 73,770 |
Cash, cash equivalents and restricted cash at end of period | 58,877 | 66,071 |
Supplemental schedule of non-cash investing and financing activities: | ||
Financing costs in accounts payable and accrued expenses | $ 68 | $ 60 |
Organization and Description of
Organization and Description of Business | 3 Months Ended |
Mar. 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 clinical stage biopharmaceutical company primarily focused on developing novel treatments for endocrine diseases where current therapies do not exist or are insufficient. The Company seeks to leverage its understanding of recent biological discoveries in endocrinology to continue to advance and build its pipeline in order to improve the lives of patients. The Company is currently 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 also has a neurokinin 3-receptor (NK3R) antagonist (MLE-301) in its research and development pipeline, which it plans to develop as a potential treatment of vasomotor symptoms (“VMS”), commonly known as hot flashes and night sweats, in menopausal women. The Company is actively pursuing additional pipeline assets in treatment areas where it has knowledge and experience in developing drug product candidates. The Company seeks to identify assets that complement its current portfolio. 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 elected to discontinue the development of livoletide as a potential treatment for PWS in April 2020 based upon results from its Phase 2b trial. The Company’s operations to date have focused on conducting preclinical studies and clinical trials, acquiring technology and assets, organization and staffing, business planning, and raising capital. The Company does not have any products approved for sale and has not generated any revenue from product sales. The Company’s product candidates are subject to long development cycles and the Company may be unsuccessful in its efforts to develop, obtain regulatory approval for or market its product candidates. The Company is subject to a number of risks including, but not limited to, the need to obtain adequate additional funding for the ongoing and planned clinical development of its product candidates. Because of the numerous risks and uncertainties associated with pharmaceutical products and development, the Company is unable to accurately predict the timing or amount of funds required to complete development of its product candidates, and costs could exceed the Company’s expectations for a number of reasons, including reasons beyond the Company’s control. Liquidity The Company has incurred net losses since inception and it expects to generate losses from operations for the foreseeable future primarily due to research and development costs for its potential product candidates. As of March 31, 2020, the Company had cash, cash equivalents and restricted cash of $58.9 million and an accumulated deficit of $220.7 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 herein (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 and restated 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 its ATM equity distribution agreement for net proceeds of approximately $5.7 million. |
Basis of Presentation and Summa
Basis of Presentation and Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 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 unaudited Interim Consolidated Financial Statements include the accounts of Millendo Therapeutics, Inc. and its subsidiaries, and all intercompany amounts have been eliminated. The unaudited Interim 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 unaudited Interim 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. Unaudited Interim Consolidated Financial Statements The Company has prepared the accompanying unaudited Interim Consolidated Financial Statements based on Securities and Exchange Commission (“SEC”) rules that permit reduced disclosure for interim periods. These unaudited Interim Consolidated Financial Statements include, in the Company’s opinion, all adjustments, consisting only of normal recurring adjustments that the Company considers necessary for a fair presentation of its consolidated financial position and results of operations for these periods. The Company’s historical results are not necessarily indicative of the results to be expected in the future and the Company’s operating results for the three months ended March 31, 2020 are not necessarily indicative of the results that may be expected for the year ending December 31, 2020. The accompanying unaudited Interim Consolidated Financial Statements should be read in conjunction with the Consolidated Financial Statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 as filed with the SEC on March 11, 2020. Since the date of such financial statements, there have been no changes to the Company’s significant accounting policies except as noted below: 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. 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. The Company anticipates that the COVID-19 pandemic will have an impact on clinical and preclinical development activities . Estimates and assumptions about future events and their effects cannot be determined with certainty and therefore require the exercise of judgment. As of the date of issuance of these financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update its estimates, assumptions and judgments or revise the carrying value of its assets or liabilities. These estimates may change as new events occur and additional information is obtained and are recognized in the consolidated financial statements as soon as they become known. Actual results could differ from those estimates and any such differences may be material to the Company’s financial statements. Significant Risks and Uncertainties With the global spread of the ongoing COVID-19 pandemic in the first quarter of 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 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. 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): March 31, 2020 2019 Stock options 3,340,732 2,381,288 Common stock warrants 17,125 17,125 BSA and BSPCE warrants 58,415 156,719 3,416,272 2,555,132 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 is in the process of evaluating the impact of this new guidance on its consolidated financial statements and related disclosures. 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 is in the process of evaluating the impact of this new guidance on its consolidated financial statements and related disclosures. 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. This 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 this ASU did not have a material impact on the 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. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements The following tables present the Company’s fair value hierarchy for assets and liabilities measured at fair value on a recurring basis (in thousands): March 31, 2020 (Level 1) (Level 2) (Level 3) Assets Money market funds (included in cash and cash equivalents) $ 51,585 $ — $ — 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 | 3 Months Ended |
Mar. 31, 2020 | |
Accrued Liabilities, Current [Abstract] | |
Accrued Expenses | Accrued Expenses Accrued expenses consist of the following (amounts in thousands): March 31, December 31, Compensation and related benefits $ 760 $ 2,042 Professional fees 2,266 2,929 Preclinical and clinical costs 2,129 1,820 Insurance premiums 831 1,423 Other 752 852 Total $ 6,738 $ 9,066 |
Debt
Debt | 3 Months Ended |
Mar. 31, 2020 | |
Debt Disclosure [Abstract] | |
Debt | Debt Bpifrance Reimbursable Advance In December, 2017, in connection with its acquisition of Alizé Pharma SAS (“Alizé”), 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. During the three months ended March 31, 2020 the Company made no principal payments due to the fact that in April 2020, Bpifrance provided a six |
Commitment and Contingencies
Commitment and Contingencies | 3 Months Ended |
Mar. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Operating Leases The Company has noncancellable operating leases for office and laboratory space which have remaining lease terms between approximately six months and four years. In connection with privately-held Millendo Therapeutics, Inc.'s merger with OvaScience, Inc. in December 2018 (the “Merger”), the Company assumed a sublease agreement for office and laboratory space located in Waltham, Massachusetts. The sublease commenced on January 15, 2019 and expires in November 2020. The total minimum sublease rentals to be received under the Waltham, Massachusetts agreement is $0.6 million. The remaining sublease rentals to be received as of March 31, 2020 is $0.2 million. In February 2019 and October 2018, the Company entered into two additional noncancellable 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 and that lease expires on September 30, 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 March 31, 2020, the operating lease ROU asset and the operating lease liabilities were $2.9 million and $3.5 million, respectively. The weighted average discount rate used to account for the Company's operating leases under ASC 842 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 $231,000 and $67,000 for the three months ended March 31, 2020 and 2019, respectively. The Company recognizes rent expense on a straight-lined basis over the lease period and has accrued for rent expense incurred but not yet paid. Cash paid for amounts included in the measurement of the lease liabilities was approximately $0.5 million and $0.2 million and the Company received approximately $87,000 and $71,000 in sublease payments related to its Waltham, Massachusetts lease during the three months ended March 31, 2020 and 2019, respectively. Future minimum rental payments under the Company’s noncancellable operating leases at March 31, 2020 is as follows (amounts in thousands): 2020 (excluding the three months ended March 31, 2020) $ 1,293 2021 760 2022 783 2023 806 2024 302 Thereafter — Total $ 3,944 Present Value Adjustment (424) Lease liability at March 31, 2020 $ 3,520 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 breaches of fiduciary duty, unjust enrichment, abuse of control, gross mismanagement and corporate waste 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. 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 and directors 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 plaintiff to file a second amended complaint under seal and permitted 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. As the mediation was unsuccessful, the parties are resuming discovery, and 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 and intends to defend against the litigation. There can be no assurance, however, that the Company will be successful. 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 duty, 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. 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 corporate waste. 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. |
Stock Based Compensation
Stock Based Compensation | 3 Months Ended |
Mar. 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. The term “Prior Plan's 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; (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 under the 2019 Plan (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 the lesser of (i) 1% of the total number of shares of the Company's capital stock outstanding on December 31 of the preceding calendar year, or (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 three months ended March 31, 2020 and 2019, respectively (amounts in thousands): Three Months Ended 2020 2019 Research and development $ 300 $ 423 General and administrative 780 516 Total $ 1,080 $ 939 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. The following table summarizes the activity related to stock option grants to employees and nonemployees for the three months ended March 31, 2020: Shares Weighted Weighted-average Outstanding at December 31, 2019 2,498,606 $ 17.18 7.7 Granted 857,875 7.72 Forfeited (15,749) 14.65 Outstanding at March 31, 2020 3,340,732 $ 14.76 8.0 Vested and exercisable at March 31, 2020 1,230,674 $ 23.08 5.8 Vested and expected to vest at March 31, 2020 3,340,732 $ 14.76 8.0 As of March 31, 2020, the unrecognized compensation cost related to 2,110,058 unvested stock options expected to vest was $12.5 million. This unrecognized compensation will be recognized over an estimated weighted-average amortization period of 3.0 years. There were no options exercised during the three months ended March 31, 2020. The aggregate intrinsic value of options outstanding and options exercisable as of March 31, 2020 was $0.6 million and $0.6 million, respectively. The options granted during the three months ended March 31, 2020 had an estimated weighted-average grant date fair value of $5.21. There were 705,133 options granted during the three months ended March 31, 2019 at an estimated weighted-average fair value of $6.45. The grant date fair value of each option grant was estimated during the three months ended March 31, 2020 and 2019 using the following assumptions within the Black-Scholes option-pricing model: Three Months Ended Three Months Ended Expected term (in years) 6.08 6.05 Expected volatility 78 % 80 % Risk-free interest rate 1.36 % 2.55 % Expected dividend yield 0 % 0 % At the time of the Alizé acquisition, Alizé had 6,219 nonemployee (BSA) warrants and 5,360 employee (BSPCE) warrants outstanding, which have weighted-average exercise prices of €80.06 and €83.40, respectively. As of March 31, 2020, all BSA and BSPCE warrants were vested. During the three months ended March 31, 2020, 910 BSPCE warrants were exercised |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events As discussed in Note 1, in April 2020, the Company elected to discontinue the development of livoletide as a potential treatment for PWS based upon results from its Phase 2b trial. The Company is in the process of estimating the amounts expected to be incurred in connection with the discontinuation of the PWS program. In connection with the discontinuation of the livoletide program in PWS, the Company is currently evaluating its business strategy to prioritize and allocate resources towards the advancement of its current product candidates and potential future pipeline assets. In an effort to streamline costs, the Company is also in the process of eliminating employee positions representing approximately 30% of its prior headcount, with the majority of the reduction in personnel completed in April 2020. The Company estimates that it will incur one-time costs of approximately $1.0 million in the form of termination benefits related to this plan in the second quarter of 2020. Subsequent events were evaluated through the filing date of this Quarterly Report on Form 10-Q. |
Basis of Presentation and Sum_2
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2020 | |
Accounting Policies [Abstract] | |
Basis of presentation and consolidation principles | Basis of presentation and consolidation principles The accompanying unaudited Interim Consolidated Financial Statements include the accounts of Millendo Therapeutics, Inc. and its subsidiaries, and all intercompany amounts have been eliminated. The unaudited Interim 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 unaudited Interim 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. |
Unaudited Interim Consolidated Financial Statements | Unaudited Interim Consolidated Financial Statements The Company has prepared the accompanying unaudited Interim Consolidated Financial Statements based on Securities and Exchange Commission (“SEC”) rules that permit reduced disclosure for interim periods. These unaudited Interim Consolidated Financial Statements include, in the Company’s opinion, all adjustments, consisting only of normal recurring adjustments that the Company considers necessary for a fair presentation of its consolidated financial position and results of operations for these periods. The Company’s historical results are not necessarily indicative of the results to be expected in the future and the Company’s operating results for the three months ended March 31, 2020 are not necessarily indicative of the results that may be expected for the year ending December 31, 2020. The accompanying unaudited Interim Consolidated Financial Statements should be read in conjunction with the Consolidated Financial Statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 as filed with the SEC on March 11, 2020. Since the date of such financial statements, there have been no changes to the Company’s significant accounting policies except as noted below: |
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. 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. The Company anticipates that the COVID-19 pandemic will have an impact on clinical and preclinical development activities . Estimates and assumptions about future events and their effects cannot be determined with certainty and therefore require the exercise of judgment. As of the date of issuance of these financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update its estimates, assumptions and judgments or revise the carrying value of its assets or liabilities. These estimates may change as new events occur and additional information is obtained and are recognized in the consolidated financial statements as soon as they become known. Actual results could differ from those estimates and any such differences may be material to the Company’s financial statements. Significant Risks and Uncertainties With the global spread of the ongoing COVID-19 pandemic in the first quarter of 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 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. |
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. 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): March 31, 2020 2019 Stock options 3,340,732 2,381,288 Common stock warrants 17,125 17,125 BSA and BSPCE warrants 58,415 156,719 3,416,272 2,555,132 |
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 is in the process of evaluating the impact of this new guidance on its consolidated financial statements and related disclosures. 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 is in the process of evaluating the impact of this new guidance on its consolidated financial statements and related disclosures. 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. This 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 this ASU did not have a material impact on the 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. |
Basis of Presentation and Sum_3
Basis of Presentation and Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Accounting Policies [Abstract] | |
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): March 31, 2020 2019 Stock options 3,340,732 2,381,288 Common stock warrants 17,125 17,125 BSA and BSPCE warrants 58,415 156,719 3,416,272 2,555,132 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Schedule of assets and liabilities measured at fair value on a recurring basis | The following tables present the Company’s fair value hierarchy for assets and liabilities measured at fair value on a recurring basis (in thousands): March 31, 2020 (Level 1) (Level 2) (Level 3) Assets Money market funds (included in cash and cash equivalents) $ 51,585 $ — $ — 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) | 3 Months Ended |
Mar. 31, 2020 | |
Accrued Liabilities, Current [Abstract] | |
Schedule of accrued expenses | Accrued expenses consist of the following (amounts in thousands): March 31, December 31, Compensation and related benefits $ 760 $ 2,042 Professional fees 2,266 2,929 Preclinical and clinical costs 2,129 1,820 Insurance premiums 831 1,423 Other 752 852 Total $ 6,738 $ 9,066 |
Commitment and Contingencies (T
Commitment and Contingencies (Tables) | 3 Months Ended |
Mar. 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 noncancellable operating leases at March 31, 2020 is as follows (amounts in thousands): 2020 (excluding the three months ended March 31, 2020) $ 1,293 2021 760 2022 783 2023 806 2024 302 Thereafter — Total $ 3,944 Present Value Adjustment (424) Lease liability at March 31, 2020 $ 3,520 |
Stock Based Compensation (Table
Stock Based Compensation (Tables) | 3 Months Ended |
Mar. 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 three months ended March 31, 2020 and 2019, respectively (amounts in thousands): Three Months Ended 2020 2019 Research and development $ 300 $ 423 General and administrative 780 516 Total $ 1,080 $ 939 |
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 three months ended March 31, 2020: Shares Weighted Weighted-average Outstanding at December 31, 2019 2,498,606 $ 17.18 7.7 Granted 857,875 7.72 Forfeited (15,749) 14.65 Outstanding at March 31, 2020 3,340,732 $ 14.76 8.0 Vested and exercisable at March 31, 2020 1,230,674 $ 23.08 5.8 Vested and expected to vest at March 31, 2020 3,340,732 $ 14.76 8.0 |
Summary of grant date fair value assumptions | The grant date fair value of each option grant was estimated during the three months ended March 31, 2020 and 2019 using the following assumptions within the Black-Scholes option-pricing model: Three Months Ended Three Months Ended Expected term (in years) 6.08 6.05 Expected volatility 78 % 80 % Risk-free interest rate 1.36 % 2.55 % Expected dividend yield 0 % 0 % |
Organization and Description _2
Organization and Description of Business (Details) - USD ($) | 1 Months Ended | ||
Mar. 31, 2020 | Dec. 31, 2019 | Apr. 30, 2019 | |
Cash, cash equivalents and marketable securities | $ 58,900,000 | ||
Accumulated deficit | $ 220,652,000 | $ 208,654,000 | |
Underwriting Agreement | |||
Common shares sold (in shares) | 4,791,667 | ||
Net proceeds from sale | $ 26,500,000 | ||
Public Offering | |||
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 | |||
Common shares sold (in shares) | 625,000 | ||
Net proceeds from sale | $ 3,500,000 | ||
At The Market Offering | |||
Common shares sold (in shares) | 719,400 | ||
Net proceeds from sale | $ 5,700,000 | ||
Aggregate offering value | $ 50,000,000 |
Basis of Presentation and Sum_4
Basis of Presentation and Summary of Significant Accounting Policies - Net Loss Per Share (Details) - shares | 3 Months Ended | |
Mar. 31, 2020 | Mar. 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 | 3,416,272 | 2,555,132 |
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 | 3,340,732 | 2,381,288 |
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 | 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 | 58,415 | 156,719 |
Fair Value Measurements - Recur
Fair Value Measurements - Recurring Basis (Details) - Recurring - Money market funds - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Level 1 | ||
Assets | ||
Money market funds | $ 51,585 | $ 59,382 |
Level 2 | ||
Assets | ||
Money market funds | 0 | 0 |
Level 3 | ||
Assets | ||
Money market funds | $ 0 | $ 0 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Accrued Liabilities, Current [Abstract] | ||
Compensation and related benefits | $ 760 | $ 2,042 |
Professional fees | 2,266 | 2,929 |
Preclinical and clinical costs | 2,129 | 1,820 |
Insurance premiums | 831 | 1,423 |
Other | 752 | 852 |
Total | $ 6,738 | $ 9,066 |
Debt - Bpifrance Reimbursable A
Debt - Bpifrance Reimbursable Advance (Details) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||
Apr. 30, 2020 | Mar. 31, 2020USD ($) | Mar. 31, 2020EUR (€) | Mar. 31, 2019USD ($) | Dec. 31, 2017USD ($) | Mar. 31, 2020EUR (€) | Dec. 31, 2017EUR (€) | |
Debt | |||||||
Reimbursement annuity (percent) | 20.00% | 20.00% | |||||
Repayment of debt | $ | $ 0 | $ 45,000 | |||||
Bpifrance | Subsequent Event | |||||||
Debt | |||||||
Principal payment deferral period | 6 months | ||||||
Alize | Bpifrance | |||||||
Debt | |||||||
Assumed debt outstanding | € | € 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 | $ | 0 | $ 45,000 | |||||
Balance outstanding | $ 400,000 | € 300,000 |
Commitments and Contingencies (
Commitments and Contingencies (Details) $ in Thousands | Jan. 15, 2019USD ($) | Mar. 31, 2020USD ($) | Mar. 31, 2019USD ($) | Feb. 28, 2019agreement | Dec. 31, 2019USD ($) |
Lessee, Lease, Description [Line Items] | |||||
Sublease income | $ 87 | $ 71 | |||
Number of non-cancelable operating lease | agreement | 2 | ||||
Right-of-use assets | 2,866 | $ 3,331 | |||
Operating lease liability | $ 3,520 | ||||
Operating lease discount rate | 7.00% | ||||
Noncancelable operating leases term | 3 years 5 months 23 days | ||||
Operating lease expense | $ 231 | 67 | |||
Cash paid for amount included in lease liabilities | 500 | $ 200 | |||
Waltham Massachusetts | |||||
Lessee, Lease, Description [Line Items] | |||||
Sublease income | $ 600 | $ 200 | |||
Minimum | |||||
Lessee, Lease, Description [Line Items] | |||||
Operating lease term | 6 months | ||||
Operating lease renewal term | 5 years | ||||
Maximum | |||||
Lessee, Lease, Description [Line Items] | |||||
Operating lease term | 4 years | ||||
Operating lease renewal term | 10 years |
Commitment and Contingencies -
Commitment and Contingencies - Future Minimum Rental Payments Under Operating Leases (Details) $ in Thousands | Mar. 31, 2020USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2020 (excluding the three months ended March 31, 2020) | $ 1,293 |
2021 | 760 |
2022 | 783 |
2023 | 806 |
2024 | 302 |
Thereafter | 0 |
Total | 3,944 |
Present Value Adjustment | (424) |
Operating lease liability | $ 3,520 |
Stock Based Compensation (Detai
Stock Based Compensation (Details) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Stock-based compensation | ||
New shares available for future issuance (in shares) | 534,320 | |
Vesting period (in years) | 4 years | |
Contractual life (in years) | 10 years | |
Unvested stock options (in shares) | 2,110,058 | |
Unrecognized compensation cost | $ 12.5 | |
Weighted average amortization period | 3 years | |
Exercise of stock options (in shares) | 0 | |
Aggregate intrinsic value of options outstanding | $ 0.6 | |
Aggregate intrinsic value of options exercisable | $ 0.6 | |
Weighted average grant date fair value, options granted (in USD per share) | $ 5.21 | $ 6.45 |
Granted (in shares) | 857,875 | 705,133 |
2019 Plan | ||
Stock-based compensation | ||
Aggregate number of shares of our common stock initially reserved for issuance (in shares) | 2,919,872 | |
Vesting period (in years) | 10 years | |
Percentage of common stock outstanding | 4.00% | |
ESPP | ||
Stock-based compensation | ||
Vesting period (in years) | 10 years | |
Percentage of common stock outstanding | 1.00% | |
Aggregate number of shares issued | 133,580 |
Stock Based Compensation - Stoc
Stock Based Compensation - Stock Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock based compensation expense | $ 1,080 | $ 939 |
Research and development | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock based compensation expense | 300 | 423 |
General and administrative | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock based compensation expense | $ 780 | $ 516 |
Stock Based Compensation - St_2
Stock Based Compensation - Stock Options (Details) - $ / shares | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | Dec. 31, 2019 | |
The activity related to stock option grants to employees and nonemployees | |||
Outstanding at beginning (in shares) | 2,498,606 | ||
Granted (in shares) | 857,875 | 705,133 | |
Forfeited (in shares) | (15,749) | ||
Outstanding at end (in shares) | 3,340,732 | 2,498,606 | |
Vested and exercisable at end (in shares) | 1,230,674 | ||
Vested and expected to vest at end (in shares) | 3,340,732 | ||
Weighted average exercise price per share | |||
Outstanding at beginning (in dollars per share) | $ 17.18 | ||
Granted (in dollars per share) | 7.72 | ||
Forfeited (in dollars per share) | 14.65 | ||
Outstanding at end (in dollars per share) | 14.76 | $ 17.18 | |
Vested and exercisable at end (in dollars per share) | 23.08 | ||
Vested and expected to vest at end (in dollars per share) | $ 14.76 | ||
Weighted-average remaining contractual life (years) | |||
Outstanding (in years) | 8 years | 7 years 8 months 12 days | |
Vested and exercisable at end (in years) | 5 years 9 months 18 days | ||
Vested and expected to vest at end (in years) | 8 years |
Stock Based Compensation - Gran
Stock Based Compensation - Grant Date Fair Value of Option (Details) | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Share-based Payment Arrangement [Abstract] | ||
Expected term (in years) | 6 years 29 days | 6 years 18 days |
Expected volatility | 78.00% | 80.00% |
Risk-free interest rate | 1.36% | 2.55% |
Expected dividend yield | 0.00% | 0.00% |
Stock Based Compensation - Aliz
Stock Based Compensation - Alize Acquisition (Details) - $ / shares | 3 Months Ended | |
Mar. 31, 2020 | Dec. 19, 2017 | |
BSA and BSPCE warrants | ||
Class of Warrant or Right [Line Items] | ||
BSA and BSPCE warrants forfeited (in shares) | 1,836 | |
BSPCE warrants | ||
Class of Warrant or Right [Line Items] | ||
BSPCE warrants exercised (in shares) | 910 | |
Common Stock | ||
Class of Warrant or Right [Line Items] | ||
Exercise of BSPCE warrants (in shares) | 12,307 | |
Alize | BSA and BSPCE warrants | ||
Class of Warrant or Right [Line Items] | ||
Weighted average exercise prices (in dollars per share) | $ 7.02 | |
Number of shares issuable upon the exercise of the warrants (in shares) | 58,415 | |
Alize | BSA and BSPCE warrants | BSA warrants | ||
Class of Warrant or Right [Line Items] | ||
Common stock warrants outstanding (in shares) | 6,219 | |
Weighted average exercise prices (in dollars per share) | $ 80.06 | |
Alize | BSA and BSPCE warrants | BSPCE warrants | ||
Class of Warrant or Right [Line Items] | ||
Common stock warrants outstanding (in shares) | 5,360 | |
Weighted average exercise prices (in dollars per share) | $ 83.40 |
Subsequent Events (Details)
Subsequent Events (Details) - Forecast - Employee Severance - PWS Clinical Development Program Discontinuation - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended |
Apr. 30, 2020 | Jun. 30, 2020 | |
Subsequent Event [Line Items] | ||
Restructuring and Related Cost, Employee Positions Eliminated, Percent | 30.00% | |
Estimated termination benefit related costs | $ 1 |