Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2019 | May 05, 2019 | |
Document and Entity Information [Abstract] | ||
Entity Registrant Name | Y-mAbs Therapeutics, Inc. | |
Entity Central Index Key | 0001722964 | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2019 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q1 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Common Stock, Shares Outstanding | 34,193,666 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
CURRENT ASSETS | ||
Cash and cash equivalents | $ 134,245 | $ 147,840 |
Restricted cash | 30 | 31 |
Other current assets | 2,759 | 3,661 |
Total current assets | 137,034 | 151,532 |
Property and equipment, net | 400 | 205 |
Operating lease right-of-use assets | 2,320 | |
Other assets | 243 | 187 |
TOTAL ASSETS | 139,997 | 151,924 |
LIABILITIES | ||
Accounts payable | 5,907 | 5,872 |
Accrued liabilities | 3,877 | 3,251 |
Operating lease liabilities, current portion | 517 | |
Total current liabilities | 10,301 | 9,123 |
Accrued milestone and royalty payments | 2,050 | 2,050 |
Operating lease liabilities, long-term portion | 2,133 | |
Other liabilities | 224 | |
TOTAL LIABILITIES | 14,484 | 11,397 |
Commitments and contingencies (Note 6) | ||
STOCKHOLDERS? EQUITY | ||
Preferred stock, $0.0001 par value, 5,500,000 shares authorized at March 31, 2019 and December 31, 2018; none issued at March 31, 2019 and December 31, 2018 | ||
Common stock, $0.0001 par value, 100,000,000 shares authorized at March 31, 2019 and December 31, 2018; 34,193,666 shares issued and outstanding at March 31, 2019, and December 31, 2018 | 3 | 3 |
Additional paid in capital | 226,216 | 225,352 |
Accumulated other comprehensive income | 63 | 7 |
Accumulated deficit | (100,769) | (84,835) |
TOTAL STOCKHOLDERS? EQUITY | 125,513 | 140,527 |
TOTAL LIABILITIES AND STOCKHOLDERS? EQUITY | $ 139,997 | $ 151,924 |
Consolidated Balance Sheets (pa
Consolidated Balance Sheets (parenthetical) - $ / shares | Mar. 31, 2019 | Dec. 31, 2018 |
Consolidated Balance Sheets | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, authorized shares | 5,500,000 | 5,500,000 |
Preferred stock, shares issued | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, authorized shares | 100,000,000 | 100,000,000 |
Common stock, shares issued | 34,193,666 | 34,193,666 |
Common stock, shares outstanding | 34,193,666 | 34,193,666 |
Consolidated Statements of Net
Consolidated Statements of Net Loss and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
OPERATING EXPENSES | ||
Research and development | $ 12,511 | $ 6,204 |
General and administrative | 3,742 | 1,275 |
Total operating expenses | 16,253 | 7,479 |
Loss from operations | (16,253) | (7,479) |
OTHER INCOME/(EXPENSES) | ||
Interest and other income/(expenses) | 319 | (4) |
NET LOSS | (15,934) | (7,483) |
Other comprehensive income | ||
Foreign currency translation | 56 | 3 |
COMPREHENSIVE LOSS | $ (15,878) | $ (7,480) |
Net loss per share attributable to common stockholders, basic and diluted | $ (0.47) | $ (0.28) |
Weighted average common shares outstanding, basic and diluted | 34,193,666 | 26,749,666 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands | Common Stock | Additional Paid in Capital | Accumulated Other Comprehensive (Loss)/Income | Accumulated Deficit | Total |
Balance at the beginning of period at Dec. 31, 2017 | $ 3 | $ 123,879 | $ (169) | $ (41,561) | $ 82,152 |
Balance at the beginning of period (in shares) at Dec. 31, 2017 | 26,749,666 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Stock-based compensation expense | 172 | 172 | |||
Foreign currency translation | 3 | 3 | |||
Net loss | (7,483) | (7,483) | |||
Balance at the end of period at Mar. 31, 2018 | $ 3 | 124,051 | (166) | (49,044) | 74,844 |
Balance at the end of period (in shares) at Mar. 31, 2018 | 26,749,666 | ||||
Balance at the beginning of period at Dec. 31, 2017 | $ 3 | 123,879 | (169) | (41,561) | 82,152 |
Balance at the beginning of period (in shares) at Dec. 31, 2017 | 26,749,666 | ||||
Balance at the end of period at Dec. 31, 2018 | $ 3 | 225,352 | 7 | (84,835) | $ 140,527 |
Balance at the end of period (in shares) at Dec. 31, 2018 | 34,193,666 | 34,193,666 | |||
Increase (Decrease) in Stockholders' Equity | |||||
Stock-based compensation expense | 864 | $ 864 | |||
Foreign currency translation | 56 | 56 | |||
Net loss | (15,934) | (15,934) | |||
Balance at the end of period at Mar. 31, 2019 | $ 3 | $ 226,216 | $ 63 | $ (100,769) | $ 125,513 |
Balance at the end of period (in shares) at Mar. 31, 2019 | 34,193,666 | 34,193,666 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net loss | $ (15,934) | $ (7,483) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 19 | |
Stock-based compensation | 864 | 172 |
Foreign currency transactions | 51 | 17 |
Changes in assets and liabilities: | ||
Other current assets | 902 | (189) |
Other assets | (56) | (192) |
Accounts payable | (134) | 1,233 |
Accrued liabilities and other | 805 | (166) |
NET CASH USED IN OPERATING ACTIVITIES | (13,483) | (6,608) |
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Purchase of property and equipment | (126) | |
NET CASH USED IN INVESTING ACTIVITIES | (126) | |
NET CASH USED IN FINANCING ACTIVITIES | ||
Payment of offering costs | (1,641) | |
NET CASH PROVIDED BY FINANCING ACTIVITIES | (1,641) | |
Effect of exchange rates on cash, cash equivalents and restricted cash | 13 | (20) |
NET INCREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH | (13,596) | (8,269) |
Cash, cash equivalents and restricted cash at the beginning of period | 147,871 | 90,515 |
Cash, cash equivalents and restricted cash at the end of period | 134,275 | 82,246 |
SUPPLEMENTAL DISCLOSURE | ||
Property and equipment purchases in accounts payable | 88 | |
Right-of-use assets obtained in exchange for lease obligations, net of amortization | $ 2,320 | |
Deferred offering costs included in other assets and accounts payable and accrued liabilities and other | $ 148 |
ORGANIZATION AND DESCRIPTION OF
ORGANIZATION AND DESCRIPTION OF BUSINESS | 3 Months Ended |
Mar. 31, 2019 | |
ORGANIZATION AND DESCRIPTION OF BUSINESS | |
ORGANIZATION AND DESCRIPTION OF BUSINESS | NOTE 1—ORGANIZATION AND DESCRIPTION OF BUSINESS Y‑mAbs Therapeutics, Inc. (“we,” “us,” “our,” the “Company,” or “Y‑mAbs”) is a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel antibody-based therapeutic products for the treatment of cancer. We have entered into a worldwide license and research collaboration agreement (the “MSK License Agreement”) with Memorial Sloan‑Kettering Cancer Center (“MSK”), under which we have obtained the exclusive rights to MSK’s rights to two clinical stage antibody‑based product development programs for the treatment of neuroblastoma and other oncology indications. The MSK License Agreement also includes a protein Multimerization Platform Technology—MULTI TAG TM , and an option to obtain the rights to certain chimeric antigen receptor T‑cell, or CAR‑T, technologies, as well as rights to certain next‑generation humanized, affinity matured bispecific antibodies. The Company is headquartered in New York and was incorporated on April 30, 2015 under the laws of the State of Delaware. |
BASIS OF PRESENTATION
BASIS OF PRESENTATION | 3 Months Ended |
Mar. 31, 2019 | |
BASIS OF PRESENTATION | |
BASIS OF PRESENTATION | NOTE 2—BASIS OF PRESENTATION The Company has not generated any revenue and has incurred losses since inception. Operations of the Company are subject to certain risks and uncertainties, including, among others, uncertainty of drug candidate development; technological uncertainty; uncertainty regarding patents and proprietary rights; uncertainty in obtaining FDA approval in the United States and regulatory approval in other jurisdictions; marketing or sales capability or experience; uncertainty in getting adequate payer coverage and reimbursement; and dependence on key personnel, compliance with government regulations and the need to obtain additional financing. Drug candidates currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval, prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel infrastructure and extensive compliance‑reporting capabilities. The Company’s drug candidates are in the development stage. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained, that any products developed will obtain necessary government regulatory approval or that any approved products will be commercially viable. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate significant revenue from product sales. The Company operates in an environment of rapid change in technology and substantial competition from pharmaceutical and biotechnology companies. The Company’s financial statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities in the ordinary course of business. The Company has experienced negative cash flows and had an accumulated deficit of $100.8 million as of March 31, 2019 and $84.8 million as of December 31, 2018. Through March 31, 2019, the Company has funded its operations through proceeds from sales of shares of its common stock, including its initial public offering, or IPO, in September 2018. As of March 31, 2019, the Company had cash and cash equivalents of $134.2 million, and as of December 31, 2018 the Company had cash and cash equivalents of $147.8 million. As of the issuance date of the quarterly financial statements for the three months ended March 31, 2019, the Company expects that its cash and cash equivalents at March 31, 2019 will be sufficient to fund its operating expenses and capital expenditure requirements through at least the next twelve months. The future viability of the Company, until such time that the Company has commercialized any of its products, is dependent on its ability to raise additional capital to finance its operations. The Company may be required to raise additional capital to fund future operations through the sale of its equity securities, incurring debt, entering into licensing or collaboration agreements with partners, grants or other sources of financing. Sufficient funds may not be available to the Company at all or on attractive terms when needed from equity or debt financing. If the Company is unable to obtain additional financing from these or other sources when needed, or to the extent needed, it may be necessary to significantly reduce its current rate of spending through delaying, scaling back, or suspending certain research and development programs and other operational goals. The accompanying unaudited consolidated financial statements reflect the accounts of the Company and its wholly‑owned subsidiary and have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information, Accounting Standards Codification (ASC) Topic 270-10 and with the instructions to Form 10-Q. Accordingly, these financial statements do not include all of the information and notes required by GAAP for complete financial statements. The unaudited interim financial statements include all adjustments (consisting only of normal recurring nature) necessary in the judgment of management for a fair statement of the results for the periods presented. All intercompany balances and transactions have been eliminated. The Company has evaluated subsequent events through the date of this filing. Operating results for the three-month period ended March 31, 2019 are not necessarily indicative of the results that may be expected for the year ended December 31, 2019, any other interim periods, or any future year or period. The December 31, 2018 consolidated balance sheet data was derived from audited financial statements, but does not include all disclosures required by GAAP. You should read these unaudited interim condensed consolidated financial statements in conjunction with the consolidated financial statements and notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 3 Months Ended |
Mar. 31, 2019 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | NOTE 3—SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Our critical accounting policies are detailed in our Annual Report on Form 10-K for the year ended December 31, 2018. Effective January 1, 2019, the Company adopted Accounting Standards Update No. 2018-09 (“ASU 2018-09”), Codification Improvements, which clarify, correct errors in, or make minor improvements to a variety of ASC topics; ASU No. 2018‑07, Compensation—Stock Compensation (Topic 718), Improvements to Nonemployee Share‑Based Payment Accounting; Accounting Standards Update No. 2018‑02, (“ASU 2018-02”), Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income; and Accounting Standards Update No. 2016‑02 (“ASU 2016‑02”), Leases. Other than the adoption of the new accounting guidance, our critical accounting policies have not changed materially from December 31, 2018. Operating Leases As described below, the Company adopted Topic 842 as of January 1, 2019. The Company determines if an arrangement includes a lease at inception. Operating lease right-of-use assets represent the Company’s right to use an underlying asset for the lease term and operating lease liabilities represent its obligation to make lease payments arising from the lease. Operating lease right-of-use assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. In determining the net present value of lease payments, the Company uses its estimated incremental borrowing rate based on information available at the lease commencement date. Because most of the Company’s leases do not provide an implicit rate of return, an incremental borrowing rate is used based on the information available at the commencement date in determining the present value of lease payments on an individual lease basis. The Company’s incremental borrowing rate for a lease is the estimated rate of interest it would have to pay on a collateralized basis to borrow an amount equal to the lease payments under similar terms. The Company’s leases may include options to extend or terminate the lease which are included in the lease term when it is reasonably certain that it will exercise any such options. None of the Company’s leases contain any residual value guarantees. Lease expense is recognized on a straight-line basis over the expected lease term. Related variable lease costs incurred are not material to the Company. The Company does not recognize right-of-use assets or related lease liabilities with a lease term of twelve months or less on our consolidated balance sheet. Topic 842 also provides practical expedients and certain exemptions for an entity’s ongoing accounting post implementation. The Company currently elected the short-term lease recognition exemption for all leases that qualify. This means, for those leases that qualify, we will not recognize right-of-use assets or liabilities, and this includes not recognizing right-of-use assets or liabilities for existing short-term leases of those assets in transition. We also elected the practical expedient to not separate lease and non-lease components for all of our leases. The Company has made an accounting policy election to account for each separate lease component of a contract and its associated non-lease components as a single lease component. See the Lease Agreements section in Note 6 for the related disclosures. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Significant estimates and assumptions reflected in these financial statements include, but are not limited to, the accrual for research and development expenses, the accrual of milestone and royalty payments, and the valuation of stock options. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates. Segment Information The Company is engaged solely in the discovery and development of novel antibody-based therapeutic products for the treatment of cancer. Accordingly, the Company has determined that it operates in one operating segment. Recently Issued Accounting Pronouncements - Adopted In August 2018, the Securities Exchange Commission (“SEC”) adopted the final rule under SEC Release No. 33-10532, Disclosure Update and Simplification, amending certain disclosure requirements that were redundant, duplicative, overlapping, outdated or superseded. In addition, the amendments expanded the disclosure requirements on the analysis of stockholders’ equity for interim financial statement. Under the amendments, an analysis of changes in each caption of stockholders’ equity presented in the balance sheet must be provided in a note or separate statement. The analysis should present a reconciliation of the beginning balance to the ending balance of each period for which a statement of comprehensive income is required to be filed. The Company’s first presentation of changes in stockholders’ equity as required under the new SEC guidance was included in its Form 10-Q for the three-month period ended March 31, 2019. In July 2018, the FASB issued Accounting Standards Update No. 2018-09 (“ASU 2018-09”), Codification Improvements, which clarify, correct errors in, or make minor improvements to a variety of ASC topics. The changes in ASU 2018-09 are not expected to have a significant effect on current accounting practices. Some of the amendments in this update do not require transition guidance and will be effective upon this update. However, many of the updates do have transition guidance with effective dates for periods beginning after December 15, 2018. The adoption of this standard on January 1, 2019 did not have a material impact on our consolidated financial statements and related disclosures. In June 2018, the FASB issued ASU No. 2018‑07, Compensation—Stock Compensation (Topic 718), Improvements to Nonemployee Share‑Based Payment Accounting (“ASU 2018‑07”). ASU 2018‑07 is intended to simplify aspects of share‑based compensation issued to non‑employees by making the guidance consistent with the accounting for employee share‑based compensation. ASU 2018‑07 is required to be adopted for annual periods beginning after December 15, 2018, including interim periods within those fiscal years. Early adoption is permitted. The adoption of this standard on January 1, 2019 did not have a material impact on our consolidated financial statements and related disclosures. In February 2018, the FASB issued Accounting Standards Update No. 2018‑02, (“ASU 2018-02”), Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income. ASU 2018‑02 allows a reclassification from accumulated other comprehensive income to retained earnings for stranded tax effects resulting from the Tax Cuts and Jobs Act. ASU 2018‑07 is required to be adopted for annual periods beginning after December 15, 2018, including interim periods within those fiscal years. Early adoption is permitted. The adoption of this standard on January 1, 2019 did not have a material impact on our consolidated financial statements and related disclosures. In February 2016, the FASB issued Accounting Standards Update No. 2016‑02 (“ASU 2016‑02”), Leases, which is effective for fiscal years, and interim periods within those years, beginning after December 15, 2018 with early adoption permitted. Under ASU 2016‑02, lessees will be required to recognize for all leases, at the commencement date of the lease, a lease liability, which is a lessee’s obligation to make lease payments arising from a lease measured on a discounted basis, and a right‑to‑use asset, which is an asset that represents the lessee’s right to use or control the use of a specified asset for the lease term. Topic 842 was subsequently amended by ASU 2017-13, Revenue and Leases: Amendments to SEC Paragraphs Pursuant to the Staff Announcement at the July 20, 2017 EITF Meeting and Rescission of Prior SEC Staff Announcements and Observer Comments; ASU 2018-01, Land Easement Practical Expedient for Transition to Topic 842; ASU No. 2018-10, Codification Improvements to Topic 842, Leases; ASU No. 2018-11, Targeted Improvements and ASU No. 2018-20, Narrow Scope Improvements for Lessors. The Company adopted the new leasing standards using the modified retrospective transition approach as of January 1, 2019, with no restatement of prior periods or cumulative adjustment to retained earnings. An entity may choose to use either (1) its effective date or (2) the beginning of the earliest comparative period presented in the financial statements as its date of initial application. The Company used the effective date as our date of initial application. Consequently, financial information was not updated and the disclosures required under the new standard are not provided for dates and periods before January 1, 2019. The new standard also provides a number of optional practical expedients in transition. The Company elected the package of practical expedients, which permits us not to reassess under the new standard our prior conclusions about lease identification, lease classification and initial direct costs. Upon adoption of the new leasing standards, the Company recognized a lease liability of $1.8 million and a related right-of-use asset of $1.5 million with the difference being due to the elimination of previously reported deferred rent. The Company subsequently entered into two new lease agreements during the three months ended March 31, 2019, and recognized an incremental lease liability and related right-of-use asset of $0.9 million. Recently Issued Accounting Pronouncements – Not Yet Adopted In August 2018, the FASB issued Accounting Standards Update No. 2018-15 (“ASU 2018-15”), Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract. ASU 2018-15 clarifies certain aspects of ASU 2015-05, Customer’s Accounting for Fees Paid in a Cloud Computing Arrangement, which was issued in April 2015. Specifically, ASU 2018-15 aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal use software (and hosting arrangements that include an internal-use software license). ASU 2018-15 is effective for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years with early adoption permitted. The Company is currently evaluating the impact its adoption may have on its consolidated financial statements. |
NET LOSS PER SHARE
NET LOSS PER SHARE | 3 Months Ended |
Mar. 31, 2019 | |
NET LOSS PER SHARE | |
NET LOSS PER SHARE | NOTE 4—NET LOSS PER SHARE Basic net loss per share (“EPS”) is calculated by dividing net income or loss attributable to common stockholders by the weighted average common stock outstanding. Diluted EPS is calculated by adjusting weighted average common shares outstanding for the dilutive effect of common stock options and restricted stock units. In periods in which a net loss is recorded, no effect is given to potentially dilutive securities, since the effect would be antidilutive. Securities that could potentially dilute basic EPS in the future were not included in the computation of diluted EPS because to do so would have been antidilutive. The calculations of basic and diluted net loss per share are as follows: Three months ended March 31, 2019 2018 Net loss (numerator) $ (15,934) $ (7,483) Weighted-average shares (denominator) 34,194 26,750 Basic and diluted net loss per share $ (0.47) $ (0.28) Potentially dilutive securities excluded from the computation of diluted earnings per share relate to stock options outstanding and unvested RSUs and totaled 3,388,169 shares as of March 31, 2019 and 2,219,000 shares as of March 31, 2018. |
ACCRUED LIABILITIES
ACCRUED LIABILITIES | 3 Months Ended |
Mar. 31, 2019 | |
ACCRUED LIABILITIES | |
ACCRUED LIABILITIES | NOTE 5—ACCRUED LIABILITIES Accrued short‑term liabilities at March 31, 2019 and December 31, 2018 are as follows: March 31, December 31, 2019 2018 (in thousands) Accrued milestone payments $ 750 $ 1,475 Accrued clinical costs 172 63 Accrued compensation and board fees 1,060 1,144 Accrued rent — 44 Accrued manufacturing costs 1,515 — Other 380 525 Total $ 3,877 $ 3,251 |
LICENSE AGREEMENTS AND COMMITME
LICENSE AGREEMENTS AND COMMITMENTS | 3 Months Ended |
Mar. 31, 2019 | |
LICENSE AGREEMENTS AND COMMITMENTS | |
LICENSE AGREEMENTS AND COMMITMENTS | NOTE 6—LICENSE AGREEMENTS AND COMMITMENTS The Company has entered into two license agreements and certain other agreements with MSK. The license agreements are further described below as the MSK License Agreement and the CD33 License Agreement. These license agreements with MSK grant the Company certain patent rights and intellectual property rights. In consideration of obtaining the patent rights and intellectual property rights, the Company agreed to make certain payments and issue shares of the Company’s common stock to MSK. Certain of the payments are contingent milestone and royalty payments, the terms of which are further described below. Amounts disclosed in the consolidated balance sheets for accrued milestone and royalty payments are inclusive of obligations under the MSK License Agreement and CD33 License Agreement, collectively. MSK License Agreement On August 20, 2015, we entered into the MSK License Agreement that grants us a worldwide, sublicensable license to MSK’s rights to certain patent rights and intellectual property rights related to certain know‑how to develop, make, and commercialize licensed products and to perform services for all therapeutic and diagnostic uses in the field of cancer diagnostics and cancer treatments. The patents and patent applications covered by this agreement are directed, in part, to naxitamab, an anti GD2 antibody, and omburtamab, which is an anti B7‑H3 antibody, as well as affinity matured versions of these certain antibodies and certain single chain variable fragments (Fv) constructs, and their use for immunotherapy, targeting the treatment of neuroblastoma, diffuse intrinsic pontine glioma (DIPG), osteosarcoma and other oncology indications. Upon entering into the MSK License Agreement in 2015 and in exchange for the licenses, we paid MSK an upfront payment, issued 1,428,500 shares of our common stock to MSK and agreed to provide certain anti‑dilution rights to MSK. In addition, we are required to pay to MSK certain royalty and milestone payments. We expensed the upfront payment and the issuance of shares to MSK in 2015. We also recorded expense related to common stock issued related to certain anti‑dilution rights held by MSK. The MSK License Agreement requires us to pay to MSK mid to high single digit royalties based on annual net sales of licensed products or the performance of licensed services by us and our affiliates and sublicensees. We are obligated to pay annual minimum royalties of $80,000 over the royalty term, commencing on the fifth anniversary of the license agreement. These amounts are non‑refundable but are creditable against royalty payments otherwise due under the MSK License Agreement. Total expensed minimum royalty payments in 2016 under the MSK License Agreement were $1,200,000, upon determination that the payment of such minimum royalties was probable and the amount was estimable in 2016. The accrued minimum royalties were recorded as long‑term accrued liabilities as of March 31, 2019 and December 31, 2018. We are also obligated to pay MSK certain clinical, regulatory and sales‑based milestone payments under the MSK License Agreement. Certain of the clinical and regulatory milestone payments become due at the earlier of completion of the related milestone activity or the date indicated in the MSK License Agreement. Total clinical and regulatory milestones potentially due under the MSK License Agreement are $2,450,000 and $9,000,000, respectively. There are also sales‑based milestones that become due should the Company achieve certain amounts of sales of licensed products resulting from the license arrangement with MSK, with total sales‑based milestones potentially due of $20,000,000. The Company records milestones in the period in which the contingent liability is probable and the amount is reasonably estimable. In addition, to the extent we enter into sublicense arrangements, we are obligated to pay to MSK a percentage of certain payments that we receive from sublicensees of the rights licensed to us by MSK, which percentage will be based upon the achievement of certain clinical milestones. The Company has not entered into any sublicenses related to the MSK License Agreement. Failure by the Company to meet certain conditions under the arrangement could cause the related license to such licensed product to be canceled and could result in termination of the entire arrangement with MSK. In addition, the Company may terminate the MSK License Agreement with prior written notice to MSK. No milestones were expensed in the three months ended March 31, 2019 or 2018. As of March 31, 2019, $150,000 of accrued milestone obligations were recorded in accrued short term liabilities and $300,000 was recorded within long-term liabilities. As of December 31, 2018, $875,000 of accrued milestone obligations were recorded in accrued short term liabilities and $300,000 was recorded within long-term liabilities. These milestone‑related charges were recorded as research and development expense in 2016, upon determination that payment of these clinical milestone obligations was probable after satisfying the financing requirements described herein. Research and development is inherently uncertain and as described above, should such research and development fail, the MSK License Agreement is cancelable at the Company’s option. The Company also considered the development risk and each party’s termination rights under the agreement when considering whether any regulatory‑based milestone payments, certain of which also contain time‑based payment requirements, were probable. Given the uncertainty associated with research and development and the Company’s ability to cancel the MSK License Agreement, such regulatory‑based obligations were determined not to be probable as of March 31, 2019 and December 31, 2018 and therefore have not been accrued. CD33 License Agreement On November 13, 2017, we entered into an exclusive license agreement for certain MSK rights in connection with certain CD33 antibodies, which we refer to as the CD33 License Agreement. The CD33 License Agreement obligates us to pay to MSK mid to high single digit royalties based on annual net sales of licensed products or the performance of licensed services by us and our affiliates and sublicensees. We are obligated to pay annual minimum royalties of $40,000 over the royalty term, increasing to $60,000 once a patent within the licensed rights is issued, and commencing on the tenth anniversary of the CD33 License Agreement. These amounts are non‑refundable but are creditable against royalty payments otherwise due under the CD33 License Agreement. We are also obligated to pay MSK certain fees under a sponsored research agreement under the CD33 License Agreement. In addition, milestone payments become due upon achievement of the related clinical, regulatory or sales‑based milestone defined in the CD33 License Agreement. Certain of the clinical and regulatory milestone payments become due at the earlier of completion of the related milestone activity or the date indicated in the CD33 License Agreement. Total potential clinical and regulatory milestones potentially due under the CD33 License Agreement are $550,000 and $500,000, respectively. There are also sales‑based milestones that become due should the Company achieve certain amounts of sales of licensed products resulting from the CD33 License Agreement with MSK, with total sales‑based milestones potentially due of $7,500,000. Failure by the Company to meet certain conditions under the CD33 License Agreement could cause the related license to such licensed product to be canceled and could result in termination of the arrangement with MSK. In addition, the Company may terminate the CD33 License Agreement with prior written notice to MSK. The Company records milestones in the period in which the contingent liability is probable and the amount is reasonably estimable. In addition, to the extent we enter into sublicense arrangements, we are obligated to pay to MSK a percentage of certain payments that we receive from sublicensees of the rights licensed to us by MSK, which percentage will be based upon the achievement of certain clinical milestones. The Company has not entered into any sublicenses related to the CD33 License Agreement. No milestones were expensed in the three months ended March 31, 2019 or 2018. None of the clinical milestone obligations previously accrued were paid in the three months ended March 30, 2019 or 2018, and the total amount accrued in prior periods of $550,000 was recorded as accrued long‑term liabilities as of March 31, 2019 and December 31, 2018. These milestone‑related charges were recorded as research and development expense in 2017. Research and development is inherently uncertain and as described above, should such research and development fail, the CD33 License Agreement is cancelable at the Company’s option. The Company considered risks as well as each party’s termination rights under the CD33 License Agreement when considering whether any regulatory‑based milestone payments and minimum royalty payments, certain of which also contain time‑based payment requirements, were probable. Given the uncertainty associated with research and development and the Company’s ability to cancel the CD33 License Agreement, such obligations were determined not to be probable as of March 31, 2019 and December 31, 2018 and therefore have not been accrued. MabVax sublicense agreement On June 27, 2018, we entered into a sublicense agreement with MabVax Therapeutics Holding, Inc (“MabVax”) pursuant to which MabVax has sublicensed to the Company certain of MabVax’s patent rights and know-how for development and commercialization of products for the prevention or treatment of neuroblastoma by means of administering a bi-valent ganglioside vaccine, granted to MabVax pursuant to an exclusive license agreement between MabVax and MSK. Under the sublicense agreement, the Company has paid a license fee of $700,000 to MabVax and will pay an additional $600,000 at the first anniversary of the sublicense agreement. The initial license fee of $700,000 was expensed and paid upon execution of the agreement and the continuation fee of $600,000 was accrued in the fourth quarter of 2018. The Company has agreed to become solely responsible for future amounts payable to MSK and to handle other of MabVax’ obligations applicable to the licensed indication towards MSK. This includes the obligation to pay development milestones totaling $1,400,000 and mid-single-digit royalty payments to MSK. Research and development is inherently uncertain and as described above, should such research and development fail, the MabVax sublicense agreement is cancelable at the Company’s option. The Company considered risks as well as each party’s termination rights under the MabVax sublicense agreement when considering whether any milestone payments and minimum royalty payments were probable. Given the uncertainty associated with research and development and the Company’s ability to cancel the MabVax sublicense agreement, such obligations were determined not to be probable as of March 31, 2019 and December 31, 2018 and therefore have not been accrued. Other agreements On November 5, 2015, we entered into a sponsored research agreement, which we refer to as the SRA, with MSK pursuant to which we agreed to pay MSK to provide research services over a period of five years related to the intellectual property licensed under the MSK License Agreement. For the three-month periods ended March 31, 2019 and 2018, we incurred research and development expenses of $306,000 and $297,000, respectively, under the SRA. On March 20, 2016, we entered into a master data services agreement, which we refer to as the MDSA, with MSK pursuant to which we committed to provide make certain payments in exchange for services provided by approximately two full time employees at MSK, who are engaged in transferring clinical data, databases, regulatory files and other know‑how included in the MSK License Agreement to the Company. On October 1, 2018 the MDSA was amended to increase the resources to approximately five full time employees. During the three months ended March 31, 2019 and 2018, we incurred expenses of $171,000 and $106,000, respectively, under the MDSA. On June 21, 2017, we entered into a master clinical trial agreement, which we refer to as the CTA, with MSK pursuant to which we committed to fund certain clinical trials at MSK. Under the MSK License Agreement, the funding of clinical activities is limited to a five-year period. During the three months ended March 31, 2019 and 2018, we incurred expenses of $853,000 and $1,631,000, respectively, under the CTA. On June 27, 2017, we entered into two separate core facility service agreements, which we refer to as the CFAs, with MSK pursuant to which we committed to obtaining certain laboratory services from MSK. During the three months ended March 31, 2019 and 2018, we incurred expenses of $219,000 and $114,000, respectively, under the CFAs. On November 13, 2017, we entered into a CD33‑sponsored research agreement, which we refer to as the CD33‑SRA, with MSK pursuant to which we agreed to pay MSK to provide research services over a period of two years related to the intellectual property licensed under the CD33 License Agreement. During the three months ended March 31, 2019 and 2018, we incurred research and development expenses of $174,000 and $167,000, respectively, under the CD33‑SRA. Lease Agreements In February 2019, the Company entered into a lease agreement in connection with its 4,500 square feet laboratory in New Jersey. The term of the lease is three years from the date the Company begins to occupy the premises, with an option to extend for an additional two years which the Company expects to exercise and has included in the determination of the related lease liability. Fixed rent payable under the lease is approximately $144,000 per annum and is payable in equal monthly installments of approximately $12,000. In January 2018, the Company entered into a lease agreement in connection with its corporate headquarters in New York. The term of the lease is five years from the date the Company begins to occupy the premises. Fixed rent payable under the lease is approximately $384,000 per annum and is payable in equal monthly installments of approximately $32,000. Additionally, the Company entered into a three‑year lease agreement for the lease of certain office space in Denmark in February 2018, as amended in November 2018 and February 2019. The lease is payable in monthly installments of approximately $19,000. Until the end of March 2018, the Company, maintained a lease for certain office space in Denmark as further described in Note 9, Related Party Transactions. As described above in Note 3, the Company adopted Topic 842 as of January 1, 2019. Prior period amounts have not been adjusted and continue to be reported in accordance with the Company’s historical accounting under Topic 840. Operating lease costs were $141,000 and $45,000 for the three months ended March 31, 2019 and 2018, respectively. During the three months ended March 31, 2019, the expenses were recorded as $97,000 in research and development expense and $44,000 in general and administrative expense. During the three months ended March 31, 2018, the expenses were all recorded in general and administrative expense. Cash paid for amounts included in the measurement of lease liabilities for the three months ended March 31, 2019 was $32,000 and was included in net cash used in operating activities in the Company’s Consolidated Statements of Cash Flows. Future minimum commitments under all non-cancelable operating leases are as follows: Operating Leases at March 31, 2019 Remainder of 2019 $ 565 Years ending December 31, 2020 756 2021 760 2022 649 2023 539 Thereafter 77 Total lease payments 3,346 Less: Imputed interest (696) Total operating lease liabilities at March 31, 2019 $ 2,650 Contractual Obligations at December 31, 2018 2019 $ 510 2020 616 2021 616 2022 616 2023 462 Thereafter 64 Total lease payments 2,884 Less: Imputed interest — Contractual obligations at December 31, 2018 $ 2,884 Operating lease liabilities are based on the net present value of the remaining lease payments over the remaining lease term. In determining the present value of lease payments, the Company uses its estimate of its incremental borrowing rate based on the information available at the lease commencement date. As of March 31, 2019, the weighted average remaining lease term is 4.6 years and the weighted average discount rate used to determine the operating lease liability was 11.0%. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 3 Months Ended |
Mar. 31, 2019 | |
STOCKHOLDERS? EQUITY | |
STOCKHOLDERS? EQUITY | NOTE 7—STOCKHOLDERS’ EQUITY Authorized Stock As of March 31, 2019 and December 31, 2018, the Company has authorized a total of 105,500,000 shares, 100,000,000 of which are common stock, par value $0.0001 per stock, and 5,500,000 of which are preferred stock, par value $0.0001 per share. Common Stock Each share of common stock is entitled to one vote. Common stockholders are entitled to receive dividends, as may be declared by the board of directors, if any, subject to preferential dividend rights of the preferred stock, none of which have been issued. The Company had issued 34,193,666 shares of its common stock as of March 31, 2019 and December 31, 2018. Preferred Stock Preferred stock may be issued from time to time in one or more series with such designations, preferences and relative participating, optional or other special rights and qualifications, limitations or restrictions as approved by the Company’s Board of Directors. No preferred stock has been issued as of March 31, 2019 or December 31, 2018. Stock grant agreements with non‑employees In August 2015, we entered into certain stock grant agreements with non‑employees of the Company. We agreed to issue a total of 2,800,000 shares to two non‑employee researchers who were involved in the development of technology licensed from MSK in consideration for their prior service. These two researchers were employees of MSK. The shares are released according to a vesting schedule. A total of 560,000 shares were issued in 2015, and a total of 448,000 shares issued in each of 2016 and 2017. In 2018 a total of 448,000 shares were issued to the two researchers, and upon completion of the IPO we issued an additional 96,000 shares. The issuance was made pursuant to a stock grant agreement and did not result in proceeds to the Company. A total of 400,000 shares are to be issued in each of 2019 and 2020 to one non-employee physician, subject to certain conditions, such that the total grant will have been issued. The total award was expensed at its estimated fair value in 2015, as no future service was required to continue to vest in and receive the shares of common stock. In August 2016, the Company repurchased and retired a total of 83,600 shares from the two non‑employees of the Company at an amount equal to the estimated fair value of $4.38 per share. The transaction reduced the Company’s shareholders’ equity by $366,000. In April 2018, the Company granted 72,373 common stock options to a non‑employee physician employed by MSK under our 2015 Equity Incentive Plan (the 2015 Plan). The options become exercisable over a four‑year period, with the first twenty‑five percent (25%) exercisable twelve (months) from the date of grant and the remainder becoming exercisable ratably each month over the three years thereafter. The contractual term of the option award is 10 years from the date of grant. The total award was expensed at its estimated fair value in April 2018, as no future service was required by the non‑employee to continue to vest in the option grant. The shares will become immediately exercisable upon the occurrence of a change in control, as defined in the 2015 Plan as further described in Note 8, Share-Based Compensation. Issuance of common stock In September 2018, we completed an initial public offering and issued 6,900,000 shares of Common Stock at a purchase price of $16.00 per share for an aggregate consideration of $99,507,000, net of issuance costs. Upon completion of the IPO we also issued 96,000 shares of our common stock. The issuance was made pursuant to a stock grant agreement and did not result in proceeds to the Company. In August 2018, we issued 448,000 shares of our common stock. The issuance was made pursuant to stock grant agreements and did not result in proceeds to the Company. |
SHARE-BASED COMPENSATION
SHARE-BASED COMPENSATION | 3 Months Ended |
Mar. 31, 2019 | |
SHARE-BASED COMPENSATION | |
SHARE-BASED COMPENSATION | NOTE 8—SHARE-BASED COMPENSATION 2015 Equity Incentive Plan Our board of directors and stockholders have approved and adopted the 2015 Equity Incentive Plan, which provides for the grant of incentive stock options, within the meaning of Section 422 of the Code (the Internal Revenue Code), to our employees and any parent and subsidiary corporations’ employees, and for the grant of incentive stock options, nonqualified stock options, stock appreciation rights, restricted stock and restricted stock units to our employees, directors and consultants and our parent and subsidiary corporations’ employees and consultants. A total of 4,500,000 shares of our common stock are reserved for issuance pursuant to the 2015 Plan. In addition, the number of shares available for issuance under the 2015 Plan will also include an annual increase on the first day of each fiscal year beginning in 2016, equal to 6% of the outstanding shares of common stock as of the last day of our immediately preceding fiscal year. The exercise price of options granted under the plans must at least be equal to the fair market value of our common stock on the date of grant. The term of an incentive stock option may not exceed 10 years, except that with respect to any participant who owns more than 10% of the voting power of all classes of our outstanding stock, the term must not exceed five years and the exercise price must equal at least 110% of the fair market value on the grant date. The administrator will determine the methods of payment of the exercise price of an option, which may include cash, shares or other property acceptable to the administrator, as well as other types of consideration permitted by applicable law. Options granted under the 2015 Plan vest according to the schedule specified in the grant agreements, which is generally a four year period and generally become immediately exercisable upon the occurrence of a change in control, as defined. Upon the 2018 Equity Incentive Plan becoming effective in September 2018, no further grants are allowed under the 2015 Equity Incentive Plan. 2018 Equity Incentive Plan Our board of directors and stockholders approved and adopted the 2018 Equity Plan, which became effective upon the Company’s initial public offering in September 2018 and which provides for the grant of incentive stock options, within the meaning of Section 422 of the Code (the Internal Revenue Code), to our employees and any parent and subsidiary corporations’ employees, and for the grant of incentive stock options, nonqualified stock options, stock appreciation rights, restricted stock and restricted stock units to our employees, directors and consultants and our parent and subsidiary corporations’ employees and consultants. A total of 5,500,000 shares of our common stock, inclusive of the awards previously granted under the 2015 Equity Incentive Plan, are reserved for issuance pursuant to the 2018 Plan. In addition, the number of shares available for issuance under the 2018 Plan will also include an annual increase on the first day of each fiscal year beginning in 2019, equal to 4% of the outstanding shares of common stock as of the last day of our immediately preceding fiscal year. The exercise price of options granted under the plans must at least be equal to the fair market value of our common stock on the date of grant. The term of an incentive stock option may not exceed 10 years, except that with respect to any participant who owns more than 10% of the voting power of all classes of our outstanding stock, the term must not exceed five years and the exercise price must equal at least 110% of the fair market value on the grant date. The administrator will determine the methods of payment of the exercise price of an option, which may include cash, shares or other property acceptable to the administrator, as well as other types of consideration permitted by applicable law. Options granted under the 2018 Plan vest according to the schedule specified in the grant agreements, which is generally a four year period and generally become immediately exercisable upon the occurrence of a change in control, as defined. Stock Option Valuation During the three month periods ended March 31, 2019 and 2018, stock based compensation for stock option grants were $848,000 and $172,000 respectively for options granted to employees and directors. During the three months ended March 31, 2019, the expenses were recorded as $145,000 in research and development expense and $703,000 in general and administrative expense. During the three months ended March 31, 2018, the expenses were recorded as $59,000 in research and development expense and $113,000 in general and administrative expense. The following table summarizes common stock options issued and outstanding: Weighted Weighted Aggregate average average intrinsic remaining exercise value contractual Options price (in thousands) life (years) Outstanding and expected to vest at December 31, 2018 3,357,873 $ 7.74 $ 43,224 7.90 Granted 20,000 $ 22.33 Outstanding and expected to vest at March 31, 2019 3,377,873 $ 7.83 $ 62,102 7.66 Exercisable at March 31, 2019 1,841,674 $ 3.09 $ 42,575 6.67 The weighted average fair value of stock options granted to employees for the three month period ended March 31, 2019 was $12.88. No options were granted during the three month period ended March 31, 2018. The aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the stock options and the fair value of the Company’s common stock for those stock options that had exercise prices lower than the fair value of the Company’s common stock. As of December 31, 2018, we had $10,848,000 of unrecognized compensation related to employee stock options that are expected to vest over a period of 2.82 years. As of March 31, 2019, we had $10,258,000 of unrecognized compensation related to employee stock options that is expected to vest over a period of 2.76 years. Restricted Stock Unit Activity During the three-month period ended March 31, 2019, stock-based compensation for restricted stock unit grants was $16,000. During the three months ended March 31, 2019, the expenses were recorded as $14,000 in research and development expense and $2,000 in general and administrative expense. There was no stock based compensation for restricted stock units during the three months ended March 31, 2018. The following table summarizes restricted stock units issued and outstanding: Restricted Stock Units Outstanding and expected to vest at December 31, 2018 — Granted 10,296 Outstanding and expected to vest at March 31, 2019 10,296 As of March 31, 2019, we had $222,000 of unrecognized compensation related to employee restricted stock units that are expected to vest over a period of 2.80 years. |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 3 Months Ended |
Mar. 31, 2019 | |
RELATED PARTY TRANSACTIONS | |
RELATED PARTY TRANSACTIONS | NOTE 9—RELATED PARTY TRANSACTIONS MSK is a shareholder of the Company and under the MSK License Agreement, the CD33 License Agreement, CTA, CFAs, SRA and MDSA, we have expensed costs in the total amount of $1,723,000 and $2,316,000 in the three months ended March 31, 2019 and 2018, respectively, for milestones, minimum royalties, research and development costs and patent activities. Please refer to Note 6 for additional details on our various agreements with MSK. As of March 31, 2019 and December 31, 2018, we had a total of $4,175,000 and $4,475,000, respectively, recorded as accounts payable and accrued liabilities related to amounts due to MSK. In July 2016, the Company entered into a lease agreement with a shareholder of the Company, Weco Group, in connection with the subsidiary in Denmark. The lease payable thereunder is approximately $4,000 per month and, as the lease can be terminated with three months’ notice, any future rent commitment thereunder will amount to approximately $12,000. The lease terminated in April 2018, when the Company moved to a new third‑party lease. In addition, the Company has reimbursed Weco Group for certain administrative expenses. The total expenses, including rent, equaled $25,000 during the three months ended March 31, 2018. No similar expenses were incurred during the three months ended March 31, 2019. |
INCOME TAXES
INCOME TAXES | 3 Months Ended |
Mar. 31, 2019 | |
INCOME TAXES | |
INCOME TAXES | NOTE 10—INCOME TAXES The Company provided no current and deferred income taxes on net losses of $15,934,000 and $7,483,000 for the three month periods ended March 31, 2019 and 2018, respectively. The Company recognizes income tax benefits for tax positions determined more likely than not to be sustained upon examination, based on the technical merits of the positions. As of March 31, 2019 and December 31, 2018, the Company has determined that there were no uncertain tax positions. The Company’s tax returns for years 2017, 2016, and 2015 are open for tax examination by U.S. federal and state, and the Danish tax authorities. The valuation allowance related primarily to net U.S. deferred tax assets from operating losses, research and development tax credit carryforwards, and acquired intangibles. The Company maintains a full valuation allowance on its U.S. and foreign deferred tax assets. The assessment regarding whether a valuation allowance is required considers both positive and negative evidence when determining whether it is more‑likely‑than‑not that deferred tax assets are recoverable. In making this assessment, significant weight is given to evidence that can be objectively verified. In its evaluation, the Company considered its cumulative loss in recent years and its forecasted losses in the near‑term as significant negative evidence. Based upon review of available positive and negative evidence, the Company determined that the negative evidence outweighed the positive evidence and a full valuation allowance on its U.S. and foreign deferred tax assets will be maintained. The Company will continue to assess the realizability of its deferred tax assets and will adjust the valuation allowance as needed. |
OTHER BENEFITS
OTHER BENEFITS | 3 Months Ended |
Mar. 31, 2019 | |
OTHER BENEFITS | |
OTHER BENEFITS | NOTE 11—OTHER BENEFITS The Company has established a retirement program for employees of our Danish subsidiary pursuant to which all such employees can contribute an amount at their election from their base compensation and may receive contributions from our Danish subsidiary. Contributions from our Danish subsidiary were immaterial during the three months ended March 31, 2019 and 2018. In addition, health insurance benefits for our Danish employees are fully paid for by such employees. Our Danish subsidiary does not incur any costs for these health insurance benefits. On October 1, 2018, the Company adopted a defined contribution 401(k) savings plan (the 401(k) plan) covering all U.S. employees of the Company. Participants may elect to defer a percentage of their pretax or after-tax compensation to the 401(k) plan, subject to defined limitations. The plan allows for a discretionary match by the Company. The Company made no matching contributions to the plan during the three months ended March 31, 2019 and 2018. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 3 Months Ended |
Mar. 31, 2019 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Operating Leases | Operating Leases As described below, the Company adopted Topic 842 as of January 1, 2019. The Company determines if an arrangement includes a lease at inception. Operating lease right-of-use assets represent the Company’s right to use an underlying asset for the lease term and operating lease liabilities represent its obligation to make lease payments arising from the lease. Operating lease right-of-use assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. In determining the net present value of lease payments, the Company uses its estimated incremental borrowing rate based on information available at the lease commencement date. Because most of the Company’s leases do not provide an implicit rate of return, an incremental borrowing rate is used based on the information available at the commencement date in determining the present value of lease payments on an individual lease basis. The Company’s incremental borrowing rate for a lease is the estimated rate of interest it would have to pay on a collateralized basis to borrow an amount equal to the lease payments under similar terms. The Company’s leases may include options to extend or terminate the lease which are included in the lease term when it is reasonably certain that it will exercise any such options. None of the Company’s leases contain any residual value guarantees. Lease expense is recognized on a straight-line basis over the expected lease term. Related variable lease costs incurred are not material to the Company. The Company does not recognize right-of-use assets or related lease liabilities with a lease term of twelve months or less on our consolidated balance sheet. Topic 842 also provides practical expedients and certain exemptions for an entity’s ongoing accounting post implementation. The Company currently elected the short-term lease recognition exemption for all leases that qualify. This means, for those leases that qualify, we will not recognize right-of-use assets or liabilities, and this includes not recognizing right-of-use assets or liabilities for existing short-term leases of those assets in transition. We also elected the practical expedient to not separate lease and non-lease components for all of our leases. The Company has made an accounting policy election to account for each separate lease component of a contract and its associated non-lease components as a single lease component. See the Lease Agreements section in Note 6 for the related disclosures. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Significant estimates and assumptions reflected in these financial statements include, but are not limited to, the accrual for research and development expenses, the accrual of milestone and royalty payments, and the valuation of stock options. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates. |
Segment Information | Segment Information The Company is engaged solely in the discovery and development of novel antibody-based therapeutic products for the treatment of cancer. Accordingly, the Company has determined that it operates in one operating segment. |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements - Adopted In August 2018, the Securities Exchange Commission (“SEC”) adopted the final rule under SEC Release No. 33-10532, Disclosure Update and Simplification, amending certain disclosure requirements that were redundant, duplicative, overlapping, outdated or superseded. In addition, the amendments expanded the disclosure requirements on the analysis of stockholders’ equity for interim financial statement. Under the amendments, an analysis of changes in each caption of stockholders’ equity presented in the balance sheet must be provided in a note or separate statement. The analysis should present a reconciliation of the beginning balance to the ending balance of each period for which a statement of comprehensive income is required to be filed. The Company’s first presentation of changes in stockholders’ equity as required under the new SEC guidance was included in its Form 10-Q for the three-month period ended March 31, 2019. In July 2018, the FASB issued Accounting Standards Update No. 2018-09 (“ASU 2018-09”), Codification Improvements, which clarify, correct errors in, or make minor improvements to a variety of ASC topics. The changes in ASU 2018-09 are not expected to have a significant effect on current accounting practices. Some of the amendments in this update do not require transition guidance and will be effective upon this update. However, many of the updates do have transition guidance with effective dates for periods beginning after December 15, 2018. The adoption of this standard on January 1, 2019 did not have a material impact on our consolidated financial statements and related disclosures. In June 2018, the FASB issued ASU No. 2018‑07, Compensation—Stock Compensation (Topic 718), Improvements to Nonemployee Share‑Based Payment Accounting (“ASU 2018‑07”). ASU 2018‑07 is intended to simplify aspects of share‑based compensation issued to non‑employees by making the guidance consistent with the accounting for employee share‑based compensation. ASU 2018‑07 is required to be adopted for annual periods beginning after December 15, 2018, including interim periods within those fiscal years. Early adoption is permitted. The adoption of this standard on January 1, 2019 did not have a material impact on our consolidated financial statements and related disclosures. In February 2018, the FASB issued Accounting Standards Update No. 2018‑02, (“ASU 2018-02”), Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income. ASU 2018‑02 allows a reclassification from accumulated other comprehensive income to retained earnings for stranded tax effects resulting from the Tax Cuts and Jobs Act. ASU 2018‑07 is required to be adopted for annual periods beginning after December 15, 2018, including interim periods within those fiscal years. Early adoption is permitted. The adoption of this standard on January 1, 2019 did not have a material impact on our consolidated financial statements and related disclosures. In February 2016, the FASB issued Accounting Standards Update No. 2016‑02 (“ASU 2016‑02”), Leases, which is effective for fiscal years, and interim periods within those years, beginning after December 15, 2018 with early adoption permitted. Under ASU 2016‑02, lessees will be required to recognize for all leases, at the commencement date of the lease, a lease liability, which is a lessee’s obligation to make lease payments arising from a lease measured on a discounted basis, and a right‑to‑use asset, which is an asset that represents the lessee’s right to use or control the use of a specified asset for the lease term. Topic 842 was subsequently amended by ASU 2017-13, Revenue and Leases: Amendments to SEC Paragraphs Pursuant to the Staff Announcement at the July 20, 2017 EITF Meeting and Rescission of Prior SEC Staff Announcements and Observer Comments; ASU 2018-01, Land Easement Practical Expedient for Transition to Topic 842; ASU No. 2018-10, Codification Improvements to Topic 842, Leases; ASU No. 2018-11, Targeted Improvements and ASU No. 2018-20, Narrow Scope Improvements for Lessors. The Company adopted the new leasing standards using the modified retrospective transition approach as of January 1, 2019, with no restatement of prior periods or cumulative adjustment to retained earnings. An entity may choose to use either (1) its effective date or (2) the beginning of the earliest comparative period presented in the financial statements as its date of initial application. The Company used the effective date as our date of initial application. Consequently, financial information was not updated and the disclosures required under the new standard are not provided for dates and periods before January 1, 2019. The new standard also provides a number of optional practical expedients in transition. The Company elected the package of practical expedients, which permits us not to reassess under the new standard our prior conclusions about lease identification, lease classification and initial direct costs. Upon adoption of the new leasing standards, the Company recognized a lease liability of $1.8 million and a related right-of-use asset of $1.5 million with the difference being due to the elimination of previously reported deferred rent. The Company subsequently entered into two new lease agreements during the three months ended March 31, 2019, and recognized an incremental lease liability and related right-of-use asset of $0.9 million. Recently Issued Accounting Pronouncements – Not Yet Adopted In August 2018, the FASB issued Accounting Standards Update No. 2018-15 (“ASU 2018-15”), Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract. ASU 2018-15 clarifies certain aspects of ASU 2015-05, Customer’s Accounting for Fees Paid in a Cloud Computing Arrangement, which was issued in April 2015. Specifically, ASU 2018-15 aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal use software (and hosting arrangements that include an internal-use software license). ASU 2018-15 is effective for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years with early adoption permitted. The Company is currently evaluating the impact its adoption may have on its consolidated financial statements. |
NET LOSS PER SHARE (Tables)
NET LOSS PER SHARE (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
NET LOSS PER SHARE | |
Schedule of basic and diluted net loss per share | Three months ended March 31, 2019 2018 Net loss (numerator) $ (15,934) $ (7,483) Weighted-average shares (denominator) 34,194 26,750 Basic and diluted net loss per share $ (0.47) $ (0.28) |
ACCRUED LIABILITIES (Tables)
ACCRUED LIABILITIES (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
ACCRUED LIABILITIES | |
Summary of accrued short-term liabilities | March 31, December 31, 2019 2018 (in thousands) Accrued milestone payments $ 750 $ 1,475 Accrued clinical costs 172 63 Accrued compensation and board fees 1,060 1,144 Accrued rent — 44 Accrued manufacturing costs 1,515 — Other 380 525 Total $ 3,877 $ 3,251 |
LICENSE AGREEMENTS AND COMMIT_2
LICENSE AGREEMENTS AND COMMITMENTS (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
LICENSE AGREEMENTS AND COMMITMENTS | |
Schedule of maturities of lease liabilities | Operating Leases at March 31, 2019 Remainder of 2019 $ 565 Years ending December 31, 2020 756 2021 760 2022 649 2023 539 Thereafter 77 Total lease payments 3,346 Less: Imputed interest (696) Total operating lease liabilities at March 31, 2019 $ 2,650 Contractual Obligations at December 31, 2018 2019 $ 510 2020 616 2021 616 2022 616 2023 462 Thereafter 64 Total lease payments 2,884 Less: Imputed interest — Contractual obligations at December 31, 2018 $ 2,884 |
SHARE-BASED COMPENSATION (Table
SHARE-BASED COMPENSATION (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
SHARE-BASED COMPENSATION | |
Schedule of common stock options issued and outstanding | Weighted Weighted Aggregate average average intrinsic remaining exercise value contractual Options price (in thousands) life (years) Outstanding and expected to vest at December 31, 2018 3,357,873 $ 7.74 $ 43,224 7.90 Granted 20,000 $ 22.33 Outstanding and expected to vest at March 31, 2019 3,377,873 $ 7.83 $ 62,102 7.66 Exercisable at March 31, 2019 1,841,674 $ 3.09 $ 42,575 6.67 |
Schedule of restricted stock units issued and outstanding | Restricted Stock Units Outstanding and expected to vest at December 31, 2018 — Granted 10,296 Outstanding and expected to vest at March 31, 2019 10,296 |
ORGANIZATION AND DESCRIPTION _2
ORGANIZATION AND DESCRIPTION OF BUSINESS (Details) | 3 Months Ended |
Mar. 31, 2019agreement | |
ORGANIZATION AND DESCRIPTION OF BUSINESS | |
Number of product development programs for which entity has obtained exclusive rights | 2 |
BASIS OF PRESENTATION (Details)
BASIS OF PRESENTATION (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
BASIS OF PRESENTATION | ||
Accumulated deficit | $ 100,769 | $ 84,835 |
Cash and cash equivalents | $ 134,245 | $ 147,840 |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Leases and Segments (Details) $ in Millions | 3 Months Ended |
Mar. 31, 2019USD ($)segment | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Residual value guarantees | $ | $ 0 |
Number of operating segments | segment | 1 |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Recently issued accounting pronouncements (Details) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019USD ($)lease | Jan. 01, 2019USD ($) | |
New accounting pronouncements | ||
Lease, Practical Expedients, Package | true | |
Lease liability | $ 2,650 | |
Operating lease right-of-use assets | $ 2,320 | |
Number of lease agreements entered into during the period | lease | 2 | |
Increase in lease liability upon entering into new lease agreements | $ 900 | |
Increase in right-of-use assets upon entering into new lease agreements | $ 900 | |
ASU 2016-02 | Adjustment | ||
New accounting pronouncements | ||
Lease liability | $ 1,800 | |
Operating lease right-of-use assets | $ 1,500 |
NET LOSS PER SHARE - Basic and
NET LOSS PER SHARE - Basic and diluted (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
NET LOSS PER SHARE | ||
Net loss (numerator) | $ (15,934) | $ (7,483) |
Weighted-average shares (denominator) | 34,193,666 | 26,749,666 |
Basic and diluted net loss per share (in dollars per share) | $ (0.47) | $ (0.28) |
NET LOSS PER SHARE - Anti-dilut
NET LOSS PER SHARE - Anti-dilutive securities (Details) - shares | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Dec. 31, 2018 | |
NET LOSS PER SHARE | ||
Potentially dilutive securities outstanding | 3,388,169 | 2,219,000 |
ACCRUED LIABILITIES (Details)
ACCRUED LIABILITIES (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Accrued short term liabilities | ||
Accrued milestone payments | $ 750 | $ 1,475 |
Accrued clinical costs | 172 | 63 |
Accrued compensation and board fees | 1,060 | 1,144 |
Accrued rent | 44 | |
Accrued manufacturing costs | 1,515 | |
Other | 380 | 525 |
Total | $ 3,877 | $ 3,251 |
LICENSE AGREEMENTS AND COMMIT_3
LICENSE AGREEMENTS AND COMMITMENTS (Details) | Mar. 31, 2019agreement |
LICENSE AGREEMENTS AND COMMITMENTS | |
Number of license agreements | 2 |
LICENSE AGREEMENTS AND COMMIT_4
LICENSE AGREEMENTS AND COMMITMENTS - MSK License Agreement (Details) - USD ($) | Aug. 20, 2015 | Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2016 | Dec. 31, 2018 |
Agreements | |||||
Accrued milestone payments, current | $ 750,000 | $ 1,475,000 | |||
MSK License Agreement | |||||
Agreements | |||||
Issuance of common stock to strategic partner (in shares) | 1,428,500 | ||||
Annual minimum royalties payable from fifth anniversary | $ 80,000 | ||||
Expensed minimum royalty payments | $ 1,200,000 | ||||
Clinical milestones potentially due | 2,450,000 | ||||
Regulatory milestones potentially due | 9,000,000 | ||||
Sales-based milestones potentially due | $ 20,000,000 | ||||
Clinical milestone expense | 0 | $ 0 | |||
MSK License Agreement | Accrued short-term liabilities | |||||
Agreements | |||||
Accrued milestone payments, current | 150,000 | 875,000 | |||
MSK License Agreement | Accrued long-term liabilities | |||||
Agreements | |||||
Accrued milestone payments, noncurrent | $ 300,000 | $ 300,000 |
LICENSE AGREEMENTS AND COMMIT_5
LICENSE AGREEMENTS AND COMMITMENTS - CD33 License Agreement (Details) - CD33 License Agreement - USD ($) | 3 Months Ended | |||
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | Nov. 13, 2017 | |
Agreements | ||||
Annual minimum royalties payable | $ 40,000 | |||
Annual minimum royalties payable from tenth anniversary | 60,000 | |||
Clinical milestones potentially due | 550,000 | |||
Regulatory milestones potentially due | 500,000 | |||
Sales-based milestones potentially due | $ 7,500,000 | |||
Clinical milestone expense | $ 0 | $ 0 | ||
Clinical milestone payment | 0 | $ 0 | ||
Accrued long-term liabilities | ||||
Agreements | ||||
Accrued milestone payments, noncurrent | $ 550,000 | $ 550,000 |
LICENSE AGREEMENTS AND COMMIT_6
LICENSE AGREEMENTS AND COMMITMENTS - MabVax sublicense agreement (Details) - MabVax sublicense agreement - USD ($) | Jun. 27, 2018 | Dec. 31, 2018 | Dec. 31, 2018 |
Agreements | |||
License fee paid | $ 700,000 | ||
Additional license fee payable at first anniversary | 600,000 | ||
License fee expense | $ 700,000 | ||
Continuation fee | $ 600,000 | ||
Development milestone payments due | $ 1,400,000 |
LICENSE AGREEMENTS AND COMMIT_7
LICENSE AGREEMENTS AND COMMITMENTS - Other agreements (Details) | Oct. 01, 2018employee | Nov. 13, 2017 | Jun. 27, 2017agreement | Jun. 21, 2017 | Mar. 20, 2016employee | Nov. 05, 2015 | Mar. 31, 2019USD ($) | Mar. 31, 2018USD ($) |
Agreements | ||||||||
Research and development | $ 12,511,000 | $ 6,204,000 | ||||||
SRA | ||||||||
Agreements | ||||||||
Research service period | 5 years | |||||||
Research and development | 306,000 | 297,000 | ||||||
MDSA | ||||||||
Agreements | ||||||||
Research and development | 171,000 | 106,000 | ||||||
Number of full-time employees | employee | 5 | 2 | ||||||
CTA | ||||||||
Agreements | ||||||||
Research service period | 5 years | |||||||
Research and development | 853,000 | 1,631,000 | ||||||
CFAs | ||||||||
Agreements | ||||||||
Number of core facility service agreements | agreement | 2 | |||||||
Research and development | 219,000 | 114,000 | ||||||
CD33-SRA | ||||||||
Agreements | ||||||||
Research service period | 2 years | |||||||
Research and development | $ 174,000 | $ 167,000 |
LICENSE AGREEMENTS AND COMMIT_8
LICENSE AGREEMENTS AND COMMITMENTS - Lease agreements (Details) | Feb. 28, 2019USD ($)ft² | Feb. 28, 2018USD ($) | Jan. 31, 2018USD ($) |
Laboratory, New Jersey | |||
Agreements | |||
Leased area (in square feet) | ft² | 4,500 | ||
Lease term | 3 years | ||
Option to extend, period | 2 years | ||
Fixed rent payable per annum | $ 144,000 | ||
Lease payable per month | $ 12,000 | ||
Corporate headquarters, New York | |||
Agreements | |||
Lease term | 5 years | ||
Fixed rent payable per annum | $ 384,000 | ||
Lease payable per month | $ 32,000 | ||
Office space, Denmark | |||
Agreements | |||
Lease term | 3 years | ||
Lease payable per month | $ 19,000 |
LICENSE AGREEMENTS AND COMMIT_9
LICENSE AGREEMENTS AND COMMITMENTS - Lease costs (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Agreements | ||
Operating lease costs | $ 141,000 | |
Rental expense for operating leases | $ 45,000 | |
Cash paid for amounts included in the measurement of lease liabilities | 32,000 | |
Research and development expense | ||
Agreements | ||
Operating lease costs | 97,000 | |
General and administrative expense | ||
Agreements | ||
Operating lease costs | $ 44,000 |
LICENSE AGREEMENTS AND COMMI_10
LICENSE AGREEMENTS AND COMMITMENTS - Lease maturities (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Future minimum commitments under all non-cancelable operating leases | ||
Remainder of 2019 | $ 565 | |
2020 | 756 | |
2021 | 760 | |
2022 | 649 | |
2023 | 539 | |
Thereafter | 77 | |
Total lease payments | 3,346 | |
Less: Imputed interest | (696) | |
Total operating lease liabilities | $ 2,650 | |
Future minimum commitments under all non-cancelable operating leases, 2018 | ||
2019 | $ 510 | |
2020 | 616 | |
2021 | 616 | |
2022 | 616 | |
2023 | 462 | |
Thereafter | 64 | |
Total lease payments | $ 2,884 |
LICENSE AGREEMENTS AND COMMI_11
LICENSE AGREEMENTS AND COMMITMENTS - Lease term and discount rate (Details) | Mar. 31, 2019 |
LICENSE AGREEMENTS AND COMMITMENTS | |
Weighted average remaining lease term | 4 years 7 months 6 days |
Weighted average discount rate | 11.00% |
STOCKHOLDERS' EQUITY - Authoriz
STOCKHOLDERS' EQUITY - Authorized, Common and Preferred Stock (Details) | 3 Months Ended | |
Mar. 31, 2019Vote$ / sharesshares | Dec. 31, 2018$ / sharesshares | |
STOCKHOLDERS? EQUITY | ||
Total shares authorized | 105,500,000 | 105,500,000 |
Common stock, authorized shares | 100,000,000 | 100,000,000 |
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 |
Preferred stock, authorized shares | 5,500,000 | 5,500,000 |
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 |
Number of votes per common share | Vote | 1 | |
Common stock, shares issued | 34,193,666 | 34,193,666 |
Preferred stock, shares issued | 0 | 0 |
STOCKHOLDERS' EQUITY - Stock gr
STOCKHOLDERS' EQUITY - Stock grant agreements with non-employees (Details) | 1 Months Ended | 12 Months Ended | ||||||||
Sep. 30, 2018shares | Aug. 31, 2018shares | Aug. 31, 2016USD ($)individual$ / sharesshares | Aug. 31, 2015individualshares | Dec. 31, 2020individualshares | Dec. 31, 2019individualshares | Dec. 31, 2018individualshares | Dec. 31, 2017shares | Dec. 31, 2016shares | Dec. 31, 2015shares | |
Stock grant agreements with non-employees | ||||||||||
Agreements | ||||||||||
Shares agreed to be issued | 2,800,000 | |||||||||
Number of non-employee physicians | individual | 2 | 2 | 2 | |||||||
Issuance of common stock to nonemployees (in shares) | 448,000 | 448,000 | 448,000 | 448,000 | 560,000 | |||||
Shares repurchased and retired | 83,600 | |||||||||
Estimated fair value of stock repurchased and retired (in dollars per share) | $ / shares | $ 4.38 | |||||||||
Reduction in equity | $ | $ (366,000) | |||||||||
Stock grant agreements with non-employees | Forecast | ||||||||||
Agreements | ||||||||||
Number of non-employee physicians | individual | 1 | 1 | ||||||||
Issuance of common stock to nonemployees (in shares) | 400,000 | 400,000 | ||||||||
Stock grant agreements with non-employees, completion of IPO | ||||||||||
Agreements | ||||||||||
Issuance of common stock to nonemployees (in shares) | 96,000 |
STOCKHOLDERS' EQUITY - Stock op
STOCKHOLDERS' EQUITY - Stock options (Details) - shares | 1 Months Ended | 3 Months Ended | |
Apr. 30, 2018 | Mar. 31, 2019 | Mar. 31, 2018 | |
Share-Based Compensation Awards | |||
Granted (in shares) | 20,000 | 0 | |
2015 Equity Incentive Plan | Nonemployees | |||
Share-Based Compensation Awards | |||
Granted (in shares) | 72,373 | ||
Vesting period | 4 years | ||
Term of award | 10 years | ||
2015 Equity Incentive Plan | Nonemployees | Tranche one | |||
Share-Based Compensation Awards | |||
Vesting period | 12 months | ||
Vesting (as a percent) | 25.00% | ||
2015 Equity Incentive Plan | Nonemployees | Tranche two | |||
Share-Based Compensation Awards | |||
Vesting period | 3 years |
STOCKHOLDERS' EQUITY - Issuance
STOCKHOLDERS' EQUITY - Issuance of common stock (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||||
Sep. 30, 2018 | Aug. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
IPO | ||||||
Issuance of common stock | ||||||
Shares issued | 6,900,000 | |||||
Share price (in dollars per share) | $ 16 | |||||
Proceeds from issuance of common stock, net of issuance costs | $ 99,507,000 | |||||
Stock grant agreements with non-employees | ||||||
Issuance of common stock | ||||||
Issuance of common stock to nonemployees (in shares) | 448,000 | 448,000 | 448,000 | 448,000 | 560,000 | |
Stock grant agreements with non-employees, completion of IPO | ||||||
Issuance of common stock | ||||||
Issuance of common stock to nonemployees (in shares) | 96,000 |
SHARE-BASED COMPENSATION - 2015
SHARE-BASED COMPENSATION - 2015 Equity Incentive Plan (Details) - 2015 Equity Incentive Plan | 3 Months Ended |
Mar. 31, 2019shares | |
Share-Based Compensation Awards | |
Shares reserved for issuance pursuant to the plan | 4,500,000 |
Annual increase on share reserve (as a percent) | 6.00% |
Stock options | Employees and nonemployees owning less than 10% of voting power | |
Share-Based Compensation Awards | |
Term of award | 10 years |
Vesting period | 4 years |
Stock options | Participants owning more than 10% of voting power | |
Share-Based Compensation Awards | |
Term of award | 5 years |
Stock options | Participants owning more than 10% of voting power | Minimum | |
Share-Based Compensation Awards | |
Ownership (as a percent) | 10.00% |
Option price as percentage of fair market value of common stock on the date of grant | 110.00% |
SHARE-BASED COMPENSATION - 2018
SHARE-BASED COMPENSATION - 2018 Equity Incentive Plan (Details) - shares | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Share-Based Compensation Awards | ||
Options granted (in shares) | 20,000 | 0 |
2018 Equity Incentive Plan | ||
Share-Based Compensation Awards | ||
Shares reserved for issuance pursuant to the plan | 5,500,000 | |
Annual increase on share reserve (as a percent) | 4.00% | |
2018 Equity Incentive Plan | Stock options | Employees and nonemployees owning less than 10% of voting power | ||
Share-Based Compensation Awards | ||
Term of award | 10 years | |
Vesting period | 4 years | |
2018 Equity Incentive Plan | Stock options | Participants owning more than 10% of voting power | ||
Share-Based Compensation Awards | ||
Term of award | 5 years | |
2018 Equity Incentive Plan | Stock options | Participants owning more than 10% of voting power | Minimum | ||
Share-Based Compensation Awards | ||
Ownership (as a percent) | 10.00% | |
Option price as percentage of fair market value of common stock on the date of grant | 110.00% |
SHARE-BASED COMPENSATION - Expe
SHARE-BASED COMPENSATION - Expense (Details) - Stock options - Employees - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Share-Based Compensation Awards | ||
Stock-based compensation expenses | $ 848,000 | $ 172,000 |
Research and development expense | ||
Share-Based Compensation Awards | ||
Stock-based compensation expenses | 145,000 | 59,000 |
General and administrative expense | ||
Share-Based Compensation Awards | ||
Stock-based compensation expenses | $ 703,000 | $ 113,000 |
SHARE-BASED COMPENSATION - Stoc
SHARE-BASED COMPENSATION - Stock options (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | |
Options | |||
Outstanding at beginning of period (in shares) | 3,357,873 | ||
Granted (in shares) | 20,000 | 0 | |
Outstanding at end of period (in shares) | 3,377,873 | 3,357,873 | |
Exercisable at end of period (in shares) | 1,841,674 | ||
Weighted average exercise price | |||
Outstanding at beginning of period (in dollars per share) | $ 7.74 | ||
Granted (in dollars per share) | 22.33 | ||
Outstanding at end of period (in dollars per share) | 7.83 | $ 7.74 | |
Exercisable at end of period (in dollars per share) | $ 3.09 | ||
Aggregate intrinsic value and Weighted average remaining contractual life (years) | |||
Outstanding (in dollars) | $ 62,102 | $ 43,224 | |
Exercisable (in dollars) | $ 42,575 | ||
Outstanding (in years) | 7 years 7 months 28 days | 7 years 10 months 24 days | |
Exercisable (in years) | 6 years 8 months 1 day | ||
Weighted average grant-date fair value of stock options granted (in dollars per share) | $ 12.88 |
SHARE-BASED COMPENSATION - Unre
SHARE-BASED COMPENSATION - Unrecognized compensation (Details) - Stock options - Employees - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Dec. 31, 2018 | |
Unrecognized compensation related to employee stock options | ||
Unrecognized compensation | $ 10,258,000 | $ 10,848,000 |
Expected vesting period | 2 years 9 months 4 days | 2 years 9 months 26 days |
SHARE-BASED COMPENSATION - Rest
SHARE-BASED COMPENSATION - Restricted Stock Unit Activity (Details) - RSUs - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Share-Based Compensation Awards | ||
Stock-based compensation expenses | $ 16,000 | $ 0 |
Restricted stock units issued and outstanding | ||
Granted (in shares) | 10,296 | |
Outstanding and expected to vest at end of period (in shares) | 10,296 | |
Unrecognized compensation | $ 222,000 | |
Expected vesting period | 2 years 9 months 18 days | |
Research and development expense | ||
Share-Based Compensation Awards | ||
Stock-based compensation expenses | $ 14,000 | |
General and administrative expense | ||
Share-Based Compensation Awards | ||
Stock-based compensation expenses | $ 2,000 |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details) - USD ($) | 1 Months Ended | 3 Months Ended | ||
Jul. 31, 2016 | Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | |
MSK | MSK License Agreement, the CD33 License Agreement, CTA, CFAs, SRA and MDSA | ||||
Related party transactions | ||||
Expenses | $ 1,723,000 | $ 2,316,000 | ||
Due to related parties | 4,175,000 | $ 4,475,000 | ||
Weco Group | Lease Agreement | ||||
Related party transactions | ||||
Expenses | $ 0 | $ 25,000 | ||
Lease payable per month | $ 4,000 | |||
Notice period to terminate lease | 3 months | |||
Future rent commitment | $ 12,000 |
INCOME TAXES - Expense (Details
INCOME TAXES - Expense (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Income tax expense | ||
Current income taxes | $ 0 | $ 0 |
Deferred income taxes | 0 | 0 |
Losses before taxes | $ (15,934,000) | $ (7,483,000) |
INCOME TAXES - Uncertain tax po
INCOME TAXES - Uncertain tax positions (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
INCOME TAXES | ||
Uncertain tax position | $ 0 | $ 0 |
OTHER BENEFITS (Details)
OTHER BENEFITS (Details) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
OTHER BENEFITS | ||
Employer matching contribution to defined contribution plan (as a percent) | 0.00% | 0.00% |