Document And Entity Information
Document And Entity Information - shares | 3 Months Ended | |
Mar. 31, 2019 | May 07, 2019 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q1 | |
Entity Registrant Name | INNOVATE BIOPHARMACEUTICALS, INC. | |
Entity Central Index Key | 0001551986 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Small Business | true | |
Trading Symbol | INNT | |
Entity Common Stock, Shares Outstanding (in shares) | 35,383,874 |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) | Mar. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 11,494,894 | $ 5,728,900 |
Restricted deposit | 75,000 | 75,000 |
Prepaid expenses and other current assets | 803,003 | 504,907 |
Deferred offering costs | 100,056 | 104,706 |
Total current assets | 12,472,953 | 6,413,513 |
Property and equipment, net | 29,956 | 35,095 |
Right-of-use asset | 81,992 | |
Other assets | 5,580 | 5,580 |
Total assets | 12,590,481 | 6,454,188 |
Current liabilities: | ||
Accounts payable | 3,928,685 | 3,618,634 |
Accrued expenses | 897,255 | 826,327 |
Convertible note payable | 3,736,803 | 5,196,667 |
Warrant liabilities | 1,113,000 | 0 |
Derivative liability | 1,180,000 | 370,000 |
Accrued interest | 35,139 | 101,624 |
Lease liability, current portion | 53,014 | |
Total current liabilities | 10,943,896 | 10,113,252 |
Lease liability, net of current portion | 28,978 | |
Total liabilities | 10,972,874 | 10,113,252 |
Commitments and contingencies (Note 8) | ||
Stockholders’ equity (deficit): | ||
Preferred stock $0.0001 par value, 10,000,000 shares authorized; 0 shares issued and outstanding as of March 31, 2019 and December 31, 2018, respectively | 0 | 0 |
Common stock - $0.0001 par value, 350,000,000 shares authorized; 31,065,602 and 26,088,820 shares issued and outstanding as of March 31, 2019 and December 31, 2018, respectively | 3,107 | 2,609 |
Additional paid-in capital | 49,565,235 | 39,854,297 |
Accumulated deficit | (47,950,735) | (43,515,970) |
Total stockholders’ equity (deficit) | 1,617,607 | (3,659,064) |
Total liabilities and stockholders’ equity | $ 12,590,481 | $ 6,454,188 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2019 | Dec. 31, 2018 |
Statement of Financial Position [Abstract] | ||
Common stock, par or stated value per share (in usd per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 350,000,000 | 350,000,000 |
Common stock, shares, issued (in shares) | 31,065,602 | 26,088,820 |
Common stock, shares, outstanding (in shares) | 31,065,602 | 26,088,820 |
Preferred stock, par or stated value per share (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Condensed Statements of Operati
Condensed Statements of Operations and Comprehensive Loss - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Operating expenses: | ||
Research and development | $ 1,198,315 | $ 6,358,004 |
General and administrative | 3,114,495 | 4,970,613 |
Total operating expenses | 4,312,810 | 11,328,617 |
Loss from operations | (4,312,810) | (11,328,617) |
Interest Income, Other | 26,456 | 30,492 |
Other income (expense): | ||
Interest expense | (427,245) | (3,661,619) |
Loss on extinguishment of convertible note payable | (1,049,166) | 0 |
Change in fair value of derivative liability | 471,000 | 0 |
Change in fair value of warrant liability | 857,000 | 0 |
Total other expense, net | (121,955) | (3,631,127) |
Loss before income taxes | (4,434,765) | (14,959,744) |
Benefit from income taxes | 0 | 0 |
Net loss | $ (4,434,765) | $ (14,959,744) |
Net loss per common share, basic and diluted (in usd per share) | $ (0.16) | $ (0.70) |
Weighted-average common shares, basic and diluted (in shares) | 27,252,278 | 21,243,905 |
Condensed Statements of Stockho
Condensed Statements of Stockholders’ Equity (Deficit) - USD ($) | Total | Common Stock | Additional Paid-in Capital | Accumulated Deficit | |
Balance (in shares) at Dec. 31, 2017 | [1] | 11,888,240 | |||
Balance at Dec. 31, 2017 | $ (12,174,614) | $ 11,888 | $ 7,167,189 | $ (19,353,691) | |
Stockholders' Equity [Roll Forward] | |||||
Change in par value from $0.001 to $0.0001 | 0 | $ (10,699) | 10,699 | ||
Issuance of shares as a result of reverse recapitalization (in shares) | [1] | 1,864,808 | |||
Issuance of shares as a result of reverse recapitalization | (978,674) | $ 186 | (978,860) | ||
Issuance of common stock (in shares) | [1] | 7,111,631 | |||
Issuance of common stock and warrants | 16,137,661 | $ 711 | 16,136,950 | ||
Stock issuance costs | (2,568,079) | (2,568,079) | |||
Share-based compensation | 7,174,000 | 7,174,000 | |||
Warrants issued with common stock | 1,995,000 | 1,995,000 | |||
Warrants issued to placement agents | 913,000 | 913,000 | |||
Conversion of convertible debt and accrued interest (in shares) | [1] | 4,827,001 | |||
Conversion of convertible debt and accrued interest | 9,229,819 | $ 483 | 9,229,336 | ||
Beneficial conversion feature | 3,077,887 | 3,077,887 | |||
Net loss | (14,959,744) | (14,959,744) | |||
Balance (in shares) at Mar. 31, 2018 | [1] | 25,691,680 | |||
Balance at Mar. 31, 2018 | 7,846,256 | $ 2,569 | 42,157,122 | (34,313,435) | |
Balance (in shares) at Dec. 31, 2018 | 26,088,820 | ||||
Balance at Dec. 31, 2018 | (3,659,064) | $ 2,609 | 39,854,297 | (43,515,970) | |
Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock (in shares) | 4,886,782 | ||||
Issuance of common stock and warrants | 11,475,255 | $ 489 | 11,474,766 | ||
Allocation of warrants to liabilities | (1,970,000) | (1,970,000) | |||
Stock issuance costs | (319,819) | (319,819) | |||
Share-based compensation | 526,000 | 526,000 | |||
Issuance of RSUs (in shares) | 90,000 | ||||
Issuance of RSUs | 0 | $ 9 | (9) | ||
Net loss | (4,434,765) | (4,434,765) | |||
Balance (in shares) at Mar. 31, 2019 | 31,065,602 | ||||
Balance at Mar. 31, 2019 | $ 1,617,607 | $ 3,107 | $ 49,565,235 | $ (47,950,735) | |
[1] | Common shares adjusted for the exchange ratio from the reverse recapitalization |
Condensed Statements of Stock_2
Condensed Statements of Stockholders' Equity (Deficit) - Parenthetical - $ / shares | Mar. 31, 2019 | Dec. 31, 2018 | Mar. 31, 2018 | Dec. 31, 2017 |
Statement of Stockholders' Equity [Abstract] | ||||
Common stock, par or stated value per share (in usd per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.001 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Cash flows from operating activities | ||
Net loss | $ (4,434,765) | $ (14,959,744) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Share-based compensation | 526,000 | 7,174,000 |
Accrued interest on convertible notes | 35,139 | 25,578 |
Amortization of debt discount | 74,803 | 427,866 |
Depreciation | 5,139 | 2,688 |
Beneficial conversion feature | 0 | 3,077,887 |
Change in fair value of derivative liability | (101,000) | 0 |
Change in fair value of warrant liability | (857,000) | 0 |
Extinguishment of derivative liability | (370,000) | 0 |
Loss on extinguishment of debt | 1,049,166 | 0 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | (298,096) | (88,917) |
Accounts payable | 163,564 | (1,612,347) |
Accrued expenses | 70,928 | (1,014,502) |
Accrued interest | (101,624) | 0 |
Net cash used in operating activities | (4,237,746) | (6,967,491) |
Cash flows from investing activities | ||
Purchase of property and equipment | 0 | (13,943) |
Loan payments from related party | 0 | 75,000 |
Net cash provided by (used in) investing activities | 0 | 61,057 |
Cash flows from financing activities | ||
Borrowings from convertible notes | 5,000,000 | 3,345,000 |
Payments of convertible notes | (6,245,833) | (275,000) |
Payments of debt issuance costs | (57,000) | (20,000) |
Proceeds from issuance of common stock and warrants | 11,475,255 | 18,132,661 |
Payment of deferred offering costs | (168,682) | (1,655,079) |
Net cash provided by financing activities | 10,003,740 | 19,527,582 |
Net increase in cash and cash equivalents | 5,765,994 | 12,621,148 |
Cash and cash equivalents as of beginning of period | 5,728,900 | 355,563 |
Cash and cash equivalents as of end of period | 11,494,894 | 12,976,711 |
Supplemental disclosure of cash flow information | ||
Cash paid during the period for interest | 418,927 | 130,288 |
Supplemental disclosure of non-cash financing activities | ||
Conversion of convertible notes and accrued interest to common stock | 0 | 9,229,336 |
Assumption of liabilities from reverse recapitalization transaction | 0 | 978,674 |
Warrants issued to placement agents | 0 | 913,000 |
Non-cash addition of derivative liability | 1,281,000 | 0 |
Non-cash addition of deferred offering costs | $ 151,137 | $ 0 |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Business Description Innovate Biopharmaceuticals, Inc. (the “Company” or “Innovate”) is a clinical-stage biopharmaceutical company developing novel medicines for autoimmune and inflammatory diseases with unmet medical needs. The Company’s pipeline includes drug candidates for celiac disease, nonalcoholic steatohepatitis (NASH), alcoholic steatohepatitis (ASH), Crohn’s disease, and ulcerative colitis. On January 29, 2018, Monster Digital, Inc. (“Monster”) and privately held Innovate Biopharmaceuticals Inc. (“Private Innovate”) completed a reverse recapitalization in accordance with the terms of the Agreement and Plan of Merger and Reorganization, dated July 3, 2017, as amended (the “Merger Agreement”), by and among Monster, Monster Merger Sub, Inc. (“Merger Sub”) and Private Innovate. In connection with the transaction, Private Innovate changed its name to IB Pharmaceuticals Inc. (“IB Pharmaceuticals”). Pursuant to the Merger Agreement, Merger Sub merged with and into IB Pharmaceuticals with IB Pharmaceuticals surviving as the wholly owned subsidiary of Monster (the “Merger”). Immediately following the Merger, Monster changed its name to Innovate Biopharmaceuticals, Inc. (“Innovate”). On March 29, 2018, IB Pharmaceuticals was merged into Innovate and ceased to exist. Monster, a Delaware corporation (formed in November 2010), and its subsidiary SDJ Technologies, Inc. (“SDJ”), was an importer of high-end memory storage products, flash memory and action sports cameras marketed and sold under the Monster Digital brand name acquired under a long-term licensing agreement with Monster, Inc. In September 2017, Monster incorporated MD Holding Co, Inc. (“MDH”), a Delaware corporation, and transferred all of the businesses and assets of Monster, including all shares of SDJ and those liabilities of Monster not assumed by Innovate pursuant to the Merger to MDH. In January 2018, the name of MDH was changed to NLM Holding Co., Inc. On January 29, 2018, prior to the Merger, Private Innovate completed an equity financing (the “Equity Issuance”). See Note 3—Merger and Financing. Basis of Presentation The unaudited condensed interim financial statements have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial reporting. These financial statements are unaudited and, in the opinion of management, include all adjustments (consisting of normal recurring adjustments and accruals) necessary for a fair statement of the balance sheets, operating results, and cash flows for the periods presented in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). Operating results for the three months ended March 31, 2019 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2019 . Certain information and footnote disclosure normally included in the annual financial statements prepared in accordance with U.S. GAAP have been omitted in accordance with the SEC’s rules and regulations for interim reporting. The Company’s financial position, results of operations and cash flows are presented in U.S. Dollars. Upon the closing of the Merger, the outstanding shares of Private Innovate were exchanged for shares of common stock of Monster at an exchange ratio of one share of Private Innovate common stock to 0.37686604 shares of Monster common stock (the “Exchange Ratio”). All common share amounts and per share amounts have been adjusted to reflect this Exchange Ratio, which was effected upon the Merger. The Merger has been accounted for as a reverse recapitalization. Prior to the Merger, Monster spun-out all of its pre-merger business assets and liabilities before it acquired Private Innovate. The owners and management of Private Innovate have actual or effective voting and operating control of the combined company. In the Merger transaction, Monster is the accounting acquiree and Private Innovate is the accounting acquirer. A reverse recapitalization is equivalent to the issuance of stock by the private operating company for the net monetary assets of the accounting acquiree accompanied by a recapitalization with accounting similar to that resulting from a reverse acquisition, except that no goodwill or intangible assets are recorded. Immediately prior to the effective time of the Merger, Monster effected a reverse stock split at a ratio of one new share for every ten shares of its common stock outstanding. In connection with the Merger, 1,864,808 shares of the Company’s common stock were transferred to the existing Monster stockholders and the Company assumed approximately $1.0 million in liabilities from Monster for certain transaction costs and tail insurance coverage for its directors and officers, which were recorded as a reduction of additional paid-in capital. In addition, warrants to purchase up to 154,403 shares of the Company’s common stock remained outstanding after completion of the Merger. These warrants have a weighted-average exercise price of $55.31 per share and expire in 2021 and 2022 . The accompanying unaudited financial statements and related notes reflect the historical results of Private Innovate prior to the Merger and of the combined company following the Merger, and do not include the historical results of Monster prior to the completion of the Merger. These financial statements and related notes should be read in conjunction with the audited financial statements and related notes thereto for the year ended December 31, 2018 , included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018 , filed with the SEC on March 18, 2019. Except as noted below under the section entitled “Recently Issued Accounting Standards—Accounting Pronouncements Adopted”, there have been no material changes to the Company’s significant accounting policies during the three months ended March 31, 2019 , as compared to the significant accounting policies disclosed in Note 1 of the Company’s financial statements for the years ended December 31, 2018 and 2017 . However, the following accounting policies are the most critical in fully understanding the Company’s financial condition and results of operations. Shelf Registration Filing On March 15, 2018, the Company filed a shelf registration statement that was declared effective on July 13, 2018. Under the shelf registration statement, the Company may, from time to time, sell its common stock in one or more offerings up to an aggregate dollar amount of $175 million (of which up to an aggregate of $40 million may be sold in an “at-the-market” offering as defined in Rule 415 of the Securities Act). In addition, the selling stockholders included in the shelf registration statement may from time to time sell up to an aggregate amount of 13,990,403 shares of the Company’s common stock (including up to 2,051,771 shares issuable upon exercise of warrants) in one or more offerings. March 2019 Offering On March 17, 2019, the Company entered into a securities purchase agreement (the “Purchase Agreement”) with SDS Capital Partners II, LLC and certain other accredited investors, pursuant to which the Company sold, on March 18, 2019 , 4,181,068 shares of common stock and issued short-term warrants (the “Short-Term Warrants”) to purchase up to 4,181,068 shares of common stock, and long-term warrants (the “Long-Term Warrants”) to purchase up to 2,508,634 shares of common stock. Pursuant to the Purchase Agreement, the Company issued the common stock and warrants at a purchase price of $2.33 per share for aggregate proceeds of approximately $9.7 million . The Long-Term Warrants issued will be exercisable for five years commencing on the six-month anniversary of March 18, 2019, have an initial exercise price of $2.56 , subject to certain adjustments, and have an expiration date of March 18, 2024 . Any Long-Term Warrant that has not been exercised by the expiration date are automatically exercised via cashless exercise. The Short-Term Warrants are exercisable for a period of one year from March 18, 2019, have an expiration date of March 18, 2020 and have an initial exercise price of $4.00 , subject to certain adjustments. If at any time after March 18, 2019, the weighted-average price of the Company’s common stock exceeds $5.25 for ten consecutive trading days, the Company may call the outstanding Short-Term Warrants and require that they be exercised in cash, except to the extent that such exercise would surpass the beneficial ownership limitations, as specified in the Purchase Agreement. If not previously exercised in full, at the expiration of their applicable terms, the warrants shall be automatically exercised via cashless exercise. The Short-Term Warrants and Long-Term Warrants are classified as warrant liabilities on the accompanying condensed balance sheet. Business Risks The Company faces risks associated with biopharmaceutical companies whose products are in the early stages of development. These risks include, among others, the Company’s need for additional financing to achieve key development milestones, the need to defend intellectual property rights, and the dependence on key members of management. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and disclosures made in the accompanying notes to the financial statements. Areas of the financial statements where estimates may have the most significant effect include accrued expenses, share-based compensation, valuation of the derivative liability and warrant liability, valuation allowance for income tax assets and management’s assessment of the Company’s ability to continue as a going concern. Changes in the facts or circumstances underlying these estimates could result in material changes and actual results could differ from these estimates. Accrued Expenses The Company incurs periodic expenses such as research and development, licensing fees, salaries and benefits, and professional fees. The Company is required to estimate its expenses resulting from obligations under contracts with clinical research organizations, vendors and consulting agreements that have been incurred by the Company prior to being invoiced. This process involves reviewing quotations and contracts, identifying services that have been performed on the Company’s behalf and estimating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of the actual cost. The majority of the Company’s service providers invoice monthly in arrears for services performed or when contractual milestones are met. The Company estimates accrued expenses as of each balance sheet date based on facts and circumstances known at that time. Accrued expenses consisted of the following: March 31, 2019 December 31, 2018 Accrued compensation and benefits $ 659,352 $ 697,334 Other accrued expenses 237,903 128,993 Total $ 897,255 $ 826,327 Derivative Liability The Company accounts for derivative instruments in accordance with Accounting Standards Codification (“ASC”) 815, Derivative and Hedging, which establishes accounting and reporting standards for derivative instruments, including certain derivative instruments embedded in other financial instruments or contracts and requires recognition of all derivatives on the balance sheet at fair value. The Company’s derivative financial instrument consists of an embedded option in the Company’s convertible debt. The embedded derivative includes provisions that provide the noteholder with certain conversion and put rights at various conversion or redemption values as well as certain call options for the Company. See Note 4—Debt for further details. Warrant Liabilities The Company’s Short-Term Warrants and Long-Term Warrants are freestanding financial instruments that contain net settlement options and may require the Company to settle these warrants in cash under certain circumstances. As such, the Company has classified these warrants as liabilities on the accompanying condensed balance sheets in accordance with ASC 840, Distinguishing Liabilities from Equity . The warrant liabilities are initially recorded at fair value on the date of grant and will be subsequently remeasured to fair value at each balance sheet date until the warrant liabilities are settled. Changes in the fair value of the warrants are recognized as a non-cash component of other income and expense in the accompanying condensed statements of operations and comprehensive loss. Research and Development Research and development expenses consist of costs incurred to further the Company’s research and development activities and include salaries and related employee benefits, manufacturing of pharmaceutical active ingredients and drug products, costs associated with clinical trials, nonclinical activities, regulatory activities, research-related overhead expenses and fees paid to expert consultants, external service providers and contract research organizations which conduct certain research and development activities on behalf of the Company. Costs incurred in the research and development of products are charged to research and development expense as incurred. Costs for preclinical studies and clinical trial activities are recognized based on an evaluation of the vendors’ progress towards completion of specific tasks, using data such as patient enrollment, clinical site activations or information provided by vendors regarding their actual costs incurred. Payments for these activities are based on the terms of individual contracts and payment timing may differ significantly from the period in which the services were performed. The Company determines accrual estimates through reports from and discussions with applicable personnel and outside service providers as to the progress or state of completion of trials, or the services completed. The estimates of accrued expenses as of each balance sheet date are based on the facts and circumstances known at the time. Although the Company does not expect its estimates to be materially different from amounts incurred, the Company’s estimates and assumptions for clinical trial costs could differ significantly from actual costs incurred, which could result in increases or decreases in research and development expenses in future periods when actual results are known. Nonrefundable advance payments for goods and services that will be used in future research and development activities are expensed when the goods have been received or when the activity is performed, rather than when payment is made. Share-Based Compensation The Company recognizes share-based compensation expense for grants of stock options to employees and non-employee members of the Company’s board of directors based on the grant-date fair value of those awards using the Black-Scholes option-pricing model. Share-based compensation expense is generally recognized on a straight-line basis over the requisite service period for awards expected to vest. Prior to adoption of Accounting Standards Update (“ASU”) 2018-07, Compensation-Stock Compensation (Topic 718): Improvements to Non-employee Share-Based Payment Accounting , share-based compensation expense related to stock options granted to non-employees, other than non-employee directors, was adjusted each reporting period for changes in the fair value of the Company’s stock until the measurement date. The measurement date was generally considered to be the date when all services had been rendered or the date that options were fully vested. Effective January 1, 2019, the Company adopted ASU 2018-07, which no longer requires the re-measurement of the fair value for stock options awarded to non-employees. ASU 2018-07 expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from non-employees. Share-based compensation expense for both employees and non-employees includes an estimate, which is made at the time of grant, of the number of awards that are expected to be forfeited. This estimate is revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Under the Black-Scholes option-pricing model, fair value is calculated based on assumptions with respect to: • Expected dividend yield. The expected dividend yield is assumed to be zero as the Company has never paid dividends and has no current plans to pay any dividends on the Company’s common stock. • Expected stock-price volatility. Due to limited trading history as a public company, the expected volatility is derived from the average historical volatilities of publicly traded companies within the Company’s industry that the Company considers to be comparable to the Company’s business over a period approximately equal to the expected term. In evaluating comparable companies, the Company considers factors such as industry, stage of life cycle, financial leverage, size and risk profile. • Risk-free interest rate. The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of grant for zero coupon U.S. Treasury notes with maturities approximately equal to the expected term. • Expected term. The expected term represents the period that the stock-based awards are expected to be outstanding. Due to limited history of stock option exercises, the Company estimates the expected term of employee stock options based on the simplified method, which calculates the expected term as the average of the time-to-vesting and the contractual life of the options. Pursuant to ASU-2018-07, the Company has elected to use the contractual life of the option as the expected term for non-employee options. Periodically, the board may approve the grant of restricted stock units (“RSUs”), pursuant to the Innovate Biopharmaceuticals, Inc. 2012 Omnibus Incentive Plan, as amended, which represent the right to receive shares of the Company’s common stock based on terms of the agreement. The fair value of RSUs is recognized as share-based compensation expense generally on a straight-line basis over the service period, net of estimated forfeitures. The grant date fair value of an RSU represents the closing price of the Company’s common stock on the date of grant. Share-based Compensation Adjustment to Prior Period Results In preparing the Company’s financial statements for the year ended December 31, 2018, the Company determined that an immaterial error was made in the amount of share-based compensation expense recorded in the Company’s Quarterly Report on Form 10-Q for March 31, 2018, which was filed with the SEC on May 15, 2018. The error resulted in an overstatement of share-based compensation expense of approximately $1.2 million for the first quarter of 2018. The Company disclosed this error in its Annual Report on Form 10-K for the year ended December 31, 2018, which was filed with the SEC on March 18, 2019. The Company has revised its previously reported financial results for the period ending March 31, 2018 to correct the error. The Company concluded that this correction did not have a material impact on its previously issued quarterly financial statements or the audited financial statements for the year ended December 31, 2018. The financial results for the three months ended March 31, 2018 included within this Quarterly Report on Form 10-Q reflect the adjustment to the prior period. Fair Value of Financial Instruments Fair value is defined as the price that would be received for sale of an asset or paid for transfer of a liability, in an orderly transaction between market participants at the measurement date. U.S. GAAP establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). Financial instruments recorded in the accompanying condensed balance sheets are categorized based on the inputs to valuation techniques as follows: • Level 1 - defined as observable inputs based on unadjusted quoted prices for identical instruments in active markets; • Level 2 - defined as inputs other than Level 1 that are either directly or indirectly observable in the marketplace for identical or similar instruments in markets that are not active; and • Level 3 - defined as unobservable inputs in which little or no market data exists where valuations are derived from techniques in which one or more significant inputs are unobservable. The fair value of the embedded derivative issued in connection with the Senior Convertible Note and the Unsecured Convertible Note, further described in Note 4—Debt, was determined by using a Monte Carlo simulation technique (“MCS”) to value the embedded derivative associated with each note. As part of the MCS valuation, a discounted cash flow (“DCF”) model is used to value the debt on a stand-alone basis and determine the discount rate to utilize in both the DCF and MCS models. The significant estimates used in the DCF model include the time to maturity of the convertible debt and calculated discount rate, which includes an estimate of the Company’s specific risk premium. The MCS methodology calculates the theoretical value of an option based on certain parameters, including: (i) the threshold of exercising the option, (ii) the price of the underlying security, (iii) the time to expiration, or expected term, (iv) the expected volatility of the underlying security, (v) the risk-free rate and (vi) the number of paths. These valuation techniques involve management’s estimates and judgment based on unobservable inputs and are classified in Level 3. The table below summarizes the valuation inputs into the MCS model for the derivative liability associated with the Senior Convertible Note as of December 31, 2018 and for the derivative liability associated with the Unsecured Convertible Note as of March 8, 2019 and March 31, 2019. Derivative Liability March 31, March 8, December 31, 2019 2019 2018 Expected dividend yield Discount rate 29.0 % 29.3 % 13.6 % Expected stock price volatility 100.3 % 101.1 % 105.6 % Risk-free interest rate 2.5 % 2.5 % 2.5 % Expected term 23 months 24 months 21 months Price of the underlying common stock $ 1.93 $ 1.99 $ 2.31 The fair value of the warrants issued with the Purchase Agreement further described above in the section entitled “March 2019 Offering,” were determined through the use of an MCS model. The MCS methodology calculates the theoretical value of an option based on certain parameters, including (i) the threshold of exercising the option, (ii) the price of the underlying security, (iii) the time to expiration, or expected term, (iv) the expected volatility of the underlying security, (v) the risk-free interest rate and (vi) the number of paths. Given the high level of the selected volatilities, the methodology selected simulates the Company’s market value of invested capital (“MVIC”) through the maturity date of the respective warrants (one year for the Short-Term Warrants and five years for the Long-Term Warrants). Further, the estimated future stock price of the Company is calculated by subtracting the debt plus accrued interest from the MVIC. The significant estimates used in the MCS model include management’s estimated probability of future financing and liquidation events. These valuation techniques involve management’s estimates and judgment based on unobservable inputs and are classified in Level 3. The table below summarizes the valuation inputs into the MCS model for the warrant liabilities on the date of issuance and period end as of March 18, 2019 and March 31, 2019, respectively. Short-Term Warrants Long-Term Warrants March 31, 2019 March 18, 2019 March 31, 2019 March 18, 2019 Conversion price $ 4.00 $ 4.00 $ 2.56 $ 2.56 Expected stock price volatility 123.8 % 122.0 % 85.4 % 85.2 % Risk-free interest rate 2.4 % 2.5 % 2.4 % 2.2 % Expected term 1 year 1 year 5 years 5 years Price of the underlying common stock $ 1.93 $ 2.48 1.93 $ 2.48 The following table summarizes the fair value hierarchy of financial liabilities measured at fair value as of March 31, 2019 and December 31, 2018. March 31, 2019 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Derivative liability $ — $ — $ 1,180,000 $ 1,180,000 Warrant liability — — 1,113,000 1,113,000 Total liabilities at fair value $ — $ — $ 2,293,000 $ 2,293,000 December 31, 2018 Quoted Prices in Active Markets for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs Total Derivative liability $ — $ — $ 370,000 $ 370,000 Warrant liability — — — — Total liabilities at fair value $ — $ — $ 370,000 $ 370,000 The following table summarizes the changes in fair value of the derivative liability and warrant liability classified in Level 3. Gains and losses reported in this table include changes in fair value that are attributable to unobservable inputs. Three Months Ended March 31, 2019 Beginning balance as of December 31, 2018 $ 370,000 Issuance of warrant liabilities in March 2019 Offering 1,970,000 Extinguishment of derivative liability (the Senior Convertible Note) (370,000 ) Issuance of derivative liability (the Unsecured Convertible Note) 1,281,000 Change in fair value of warrant liability (857,000 ) Change in fair value of derivative liability (101,000 ) Ending balance as of March 31, 2019 $ 2,293,000 The amount of total gain for the period included in earnings attributable to the change in unrealized gains relating to the fair value liabilities still held at the reporting date $ 958,000 There were no gains or losses included in earnings attributable to changes in unrealized gains or losses for fair value assets or liabilities during the three months ended March 31, 2018. The cumulative unrealized gain relating to the change in fair value of the derivative liability and warrant liabilities of $958,000 and the extinguishment of derivative liability of $370,000 for the three months ended March 31, 2019 is included in other expense in the condensed statements of operations and comprehensive loss. ASC 820, Fair Value Measurement and Disclosures requires all entities to disclose the fair value of financial instruments, both assets and liabilities, for which it is practicable to estimate fair value. As of March 31, 2019 and December 31, 2018, the recorded values of cash and cash equivalents, restricted deposit, accounts payable, accrued expenses and convertible promissory notes approximate their fair values due to the short-term nature of the instruments. Deferred Offering Costs Deferred offering costs consist principally of legal, accounting and underwriters’ fees related to offerings or the Company’s shelf registration. Offering costs incurred prior to an offering are initially capitalized and then subsequently reclassified to additional paid-in capital upon completion of the offering. Deferred offering costs associated with the shelf registration will be charged to additional paid-in capital on a pro-rata basis in the event the Company completes an offering under the shelf registration. Offering costs incurred in the March 2019 Offering were charged to additional paid-in capital upon completion of the offering on March 18, 2019. Patent Costs Costs associated with the submission of patent applications are expensed as incurred given the uncertainty of the future economic benefits of the patents. Patent and patent related legal and administrative costs included in general and administrative expenses were approximately $161,000 and $130,000 for the three months ended March 31, 2019 and 2018 , respectively. Net Loss Per Share The Company calculates net loss per share as a measurement of the Company’s performance while giving effect to all potentially dilutive shares that were outstanding during the reporting period. Because the Company had a net loss for all periods presented, the inclusion of common stock options or other similar instruments would be anti-dilutive. Therefore, the weighted average shares outstanding used to calculate both basic and diluted net loss per share are the same. For the three months ended March 31, 2019 and 2018 , 15.8 million and 8.8 million potentially dilutive securities related to warrants and stock options issued and outstanding have been excluded from the computation of diluted weighted average shares outstanding because the effect would be anti-dilutive. The potentially dilutive securities consisted of the following: Three Months Ended 2019 2018 Options outstanding under the Private Innovate Plan 6,340,871 6,547,288 Options outstanding under the Amended Omnibus Plan 841,131 1,683 Warrants issued at a weighted-average exercise price of $55.31 154,403 154,403 Warrants issued at an exercise price of $2.54 349,555 349,555 Warrants issued at an exercise price of $3.18 1,410,358 1,702,216 Short-term warrants issued at an exercise price of $4.00 4,181,068 — Long-term warrants issued at an exercise price of $2.56 2,508,634 — Total 15,786,020 8,755,145 Segments Operating segments are defined as components of an enterprise engaging in business activities for which discrete financial information is available and regularly reviewed by the chief operating decision maker in deciding how to allocate resources and in assessing performance. The Company operates and manages its business as one operating segment and all of the Company’s operations are in North America. Recently Issued Accounting Standards Accounting Pronouncements Adopted The Company adopted ASU No. 2016-02, Leases (Topic 842) , as amended, as of January 1, 2019 using the modified retrospective approach at the beginning of the period of adoption. Under this approach, the reporting for comparative periods presented in the financial statements are presented in accordance with the legacy lease standard. In addition, the Company elected the available practical expedients permitted under the transition guidance within the new lease standard. Under the new leases standard, the Company recognizes a right-of-use (“ROU”) asset and lease liability upon commencement of a lease. The ROU represents the Company’s right to use an underlying asset for the lease term and is included in right-of-use asset on the accompanying condensed balance sheets. Lease liabilities represent the Company’s obligation to make lease payments arising from the lease and are included in current and non-current lease liability on the accompanying condensed balance sheets. Operating lease ROU assets and liabilities are recognized at the commencement date based on the present value of lease payments over the lease term. In the absence of an implicit rate, the Company uses their incremental borrowing rate based on the information available at the commencement date in determining the present value of lease payments. All leases with a term of less than 12 months are not recognized on the balance sheet. Adoption of the new leases standard resulted in the Company recognizing a ROU asset and lease liability of less than $0.1 million as of January 1, 2019. The adoption of ASU 2016-02 did not result in a cumulative adjustment to accumulated deficit. In June 2018, the FASB issued ASU 2018-07, Compensation-Stock Compensation (Topic 718): Improvements to Non-employee Share-Based Payment Accounting. ASU 2 018-07 expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from non-employees. The Company adopted this standard effective January 1, 2019. Effective January 1, 2019, the date of adoption, the Company changed its expense recognition for share-based payments to non-employees to an amount determined at the grant or modification date instead of a variable amount to be re-measured each reporting period. The Company calculated the fair value of its non-employee grants as of the adoption date and determined that there was no impact to the Company’s accumulated deficit or other components of equity upon adoption of ASU 2018-07. The unamortized expense for non-employee grants will be recognized on a straight-line basis over the remaining contractual term of the respective non-employee option agreements. The adoption of ASU 2 |
LIQUIDITY AND GOING CONCERN
LIQUIDITY AND GOING CONCERN | 3 Months Ended |
Mar. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Liquidity and Going Concern | LIQUIDITY AND GOING CONCERN The accompanying financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. The Company has concluded that the prevailing conditions and ongoing liquidity risks faced by the Company raise substantial doubt about the Company’s ability to continue as a going concern for at least 12 months following the date these financial statements are issued. Based on the Company’s limited operating history and recurring operating losses, the Company will need substantial additional funding to support its planned and future operating activities, including progression of research and development programs. Management’s plans with regard to these matters include entering into strategic partnerships or licensing arrangements or seeking additional debt or equity financing arrangements or a combination of these activities. There can be no assurance that the Company will be able to obtain additional capital on terms acceptable to the Company, on a timely basis or at all. The failure to obtain additional funding or strategic partnerships could adversely affect the Company’s ability to achieve its business objectives and product development timelines and could have a material adverse effect on the Company’s results of operations. The accompanying financial statements do not include any adjustments that might be necessary should the Company be unable to continue as a going concern. |
MERGER AND FINANCING
MERGER AND FINANCING | 3 Months Ended |
Mar. 31, 2019 | |
Business Combinations [Abstract] | |
Merger and Financing | MERGER AND FINANCING As noted above, on January 29, 2018, Private Innovate and Monster completed the Merger in accordance with the terms of the Merger Agreement. Pursuant to the Merger Agreement, Merger Sub merged with and into IB Pharmaceuticals, with IB Pharmaceuticals surviving as the wholly owned subsidiary of Monster. Immediately following the Merger, Monster changed its name to Innovate Biopharmaceuticals, Inc. On March 29, 2018, IB Pharmaceuticals was merged into Innovate and ceased to exist. Immediately prior to the closing of the Merger, accredited investors purchased shares of common stock of Private Innovate in a private placement for gross proceeds of approximately $18.1 million , or $16.5 million , net of approximately $1.6 million in placement agent fees and expenses (the “Equity Issuance”). Additionally, Private Innovate issued five -year warrants to each cash purchaser of common stock, or an aggregate of approximately 1.4 million warrants, with an exercise price of $3.18 after giving effect to the Exchange Ratio. The Company calculated the fair value of the warrants issued utilizing the Black-Scholes option pricing model with the following assumptions: expected dividend yield of 0.0% , expected stock price volatility of 84.8% , risk free rate of 2.5% , and term of 5.0 years. The proceeds were allocated between common stock and warrants utilizing the relative fair value method with the allocated warrant value of approximately $2.0 million recorded as additional paid-in capital. Private Innovate also issued 349,555 five -year warrants with an exercise price of $2.54 and 279,862 five -year warrants with an exercise price of $3.18 (after giving effect to the Exchange Ratio) to the respective placement agents and their affiliates. The Company calculated the fair value of the warrants issued utilizing the Black-Scholes option pricing model with the following assumptions: expected dividend yield of 0.0% , expected stock price volatility of 84.8% , risk free rate of 2.5% , and term of 5.0 years. The total value for these warrants approximated $913,000 and was recorded as stock issuance costs and additional paid-in capital. Concurrently with the Equity Issuance, convertible promissory notes issued by Private Innovate in the aggregate principal amount of approximately $8.6 million plus accrued interest of $582,000 were converted into shares of Private Innovate common stock at a price per share of $0.72 , prior to the Exchange Ratio (the “Conversion”), which reflected a 25% discount relative to the shares issued pursuant to the Equity Issuance (the “Conversion Discount”). The Conversion Discount represented a beneficial conversion feature of approximately $3.1 million which was recorded as a charge to interest expense and a credit to additional paid-in capital. |
DEBT
DEBT | 3 Months Ended |
Mar. 31, 2019 | |
Debt Disclosure [Abstract] | |
Debt | DEBT Senior Convertible Note On January 29, 2018, the Company entered into a Note Purchase Agreement and Senior Note Payable (the “Note”) with a lender. The principal amount of the Note was $4.8 million (“Original Principal”). The Note was issued at a discount of $1.8 million and net of $20,000 for financing costs, for total proceeds of $3.0 million . The discount and additional repayment premium were amortized to interest expense using the effective interest method through the scheduled maturity date of September 30, 2018 (the “Maturity Date”). Interest on the Note accrued from January 29, 2018, at a rate of 12.5% per annum and quarterly payments of interest only were due beginning on March 30, 2018 and compounded quarterly. The Company entered into a Waiver Agreement with the noteholder that extended the Maturity Date until October 4, 2018. On October 4, 2018, the Company entered into an Amendment and Exchange Agreement (“Exchange Agreement”) with the noteholder exchanging the Note for a new Senior Convertible Note (the “Senior Convertible Note”). The principal amount of the Senior Convertible Note was $5.2 million and bore interest at a rate of eight percent ( 8% ) per annum payable quarterly in cash, with a scheduled maturity date of October 4, 2020. The interest rate would automatically increase to 18% per annum if there was an event of default during the period. The Company evaluated the Exchange Agreement and the Senior Convertible Note and determined that the amendment to the Note constituted an extinguishment of debt, in accordance with authoritative guidance. The Company determined that there was no difference between the reacquisition price of the new debt and the net carrying amount of the extinguished debt and thus there was no gain or loss from the extinguishment. The Company incurred approximately $30,000 of legal fees associated with the Senior Convertible Note, which were recorded as debt issuance costs and are included in the amortization of debt discount discussed below. The various conversion and redemption features contained in the Senior Convertible Note are embedded derivative instruments, which were recorded as a debt discount and derivative liability at their estimated fair value. See Note 1—Summary of Significant Accounting Policies for details regarding the fair value of derivative liability. During 2018, the VWAP of the Company’s common stock was lower than the Floor Price for more than ten consecutive days. As such, the noteholder had the right to require the Company to redeem the Senior Converible Note prior to December 31, 2018, at its option. Therefore, the Company has amortized the entire debt discount to interest expense through the triggering of the redemption option, which occurred in 2018. Based on the conversion features, redemption features and subjective acceleration clauses contained in the Senior Convertible Note, the Company recorded the Senior Convertible Note as a short-term obligation as of December 31, 2018. During January 2019, the noteholder issued a redemption notice to the Company requiring the Company to repay the noteholder $1,049,167 of principal and $1,399 of accrued interest. On January 7, 2019, the Company entered into an Option to Purchase Senior Convertible Note (the “Option Agreement”) with the noteholder. The Company paid the noteholder $250,000 in consideration for the noteholder entering into the Option Agreement with the Company, which was recorded as interest expense in the accompanying statements of operations and comprehensive loss. The Option Agreement provided the Company with the ability to repay (purchase) the outstanding principal and accrued interest of the Senior Convertible Note any time from January 7, 2019 until March 31, 2019 (the “Option Period”). During March 2019, the Company exercised its repurchase rights from the Option Agreement and paid the noteholder of the Senior Convertible Note approximately $5,200,000 in principal and $60,000 in interest, which was the full purchase amount of the Senior Convertible Note pursuant to the terms of the Option Agreement. There are no further amounts outstanding under the Senior Convertible Note and the Senior Convertible Note has been canceled. The Company accounted for the repayment of the Senior Convertible Note as a liability extinguishment in accordance with ASC 405, Extinguishments of Liabilities, which resulted in the Company recording a loss on extinguishment of debt of approximately $1.0 million in the accompanying statements of operations and comprehensive loss. Amortization of debt discount for the Note and Senior Convertible Note recorded as interest expense was approximately $0.4 million for the three months ended March 31, 2018. There was no such expense for the Note and Senior Convertible Note during the three months ended March 31, 2019. Unsecured Convertible Promissory Note On March 8, 2019, the Company entered into a Securities Purchase Agreement (the “Note Purchase Agreement”) with a purchaser (the “Convertible Noteholder”). Pursuant to the Note Purchase Agreement, the Company issued the Convertible Noteholder an unsecured Convertible Promissory Note (the “Convertible Note”) in the principal amount of $5,500,000 . The Convertible Noteholder may elect to convert all or a portion of the Unsecured Convertible Note at any time and from time to time into the Company’s common stock at a conversion price of $3.25 per share, subject to adjustment for stock splits, dividends, combinations and similar events. The Company may prepay all or a portion of the Unsecured Convertible Note at any time for an amount equal to 115% of then outstanding obligations or the portion of the obligations the Company is prepaying. The purchase price of the Unsecured Convertible Note was $5,000,000 , and the Unsecured Convertible Note carries and original issuance discount (“OID”) of $500,000 , which is included in the principal amount of the Unsecured Convertible Note. In addition, the Company agreed to pay $20,000 of transaction expenses, which were netted out of the purchase price of the Unsecured Convertible Note. The Company also incurred additional transaction costs of approximately $37,000 , which were recorded as debt issuance costs. As a result of the redemption features of the Unsecured Convertible Note, further described below, the Company is amortizing the debt issuance costs and accreting the OID to interest expense over the estimated redemption period of 15 months , using the effective interest method. The various conversion and redemption features contained in the Unsecured Convertible Note are embedded derivative instruments, which were recorded as a debt discount and derivative liability at the issuance date at their estimated fair value of $1.3 million . Amortization of debt discount and accretion of the OID for the Unsecured Convertible Note recorded as interest expense was approximately $0.1 million for the three months ended March 31, 2019. The Unsecured Convertible Note consists of the following: March 31, 2019 Convertible Note $ 5,500,000 Less: unamortized debt discount and OID accretion (1,763,197 ) Total $ 3,736,803 The Unsecured Convertible Note bears interest at the rate of 10% (which will increase to 18% upon and during the continuance of an event of default) per annum, compounding on a daily basis. All principal and accrued interest on the Unsecured Convertible Note is due on the second-year anniversary of the Unsecured Convertible Note’s issuance. At any time after the six month anniversary of the issuance of the Unsecured Convertible Note, (i) if the average volume weighted average price over twenty trading dates exceeds $10.00 per share, the Company may generally require that the Unsecured Convertible Note convert into shares of its common stock at the $3.25 (as adjusted) conversion price, and (ii) the Convertible Noteholder may elect to require all or a portion of the Unsecured Convertible Note be redeemed by the Company. If the Convertible Noteholder requires a redemption, the Company, at its discretion, may pay the redeemed portion of the Unsecured Convertible Note in cash or in the Company’s common stock at a conversion rate equal to the lesser of (i) the $3.25 (as adjusted) conversion rate or (ii) 80% of the average of the five lowest volume weighted average price of the Company’s Common Stock over the preceding twenty trading days. The Convertible Noteholder may not redeem more than $500,000 per calendar month during the period between the six months anniversary of the date of issuance until the first-year anniversary of the date of issuance and $750,000 per calendar month thereafter. The obligation or right of the Company to deliver its shares upon the conversion or redemption of the Unsecured Convertible Note is subject to a 19.99% cap and subject to a floor price trading price of $3.25 (unless waived by the Company). Any amounts redeemed or converted once the cap is reached or if the market price is less than the $3.25 floor price must be paid in cash. If there is an Event of Default under the Unsecured Convertible Note, the Convertible Noteholder may accelerate the Company’s obligations or elect to increase the outstanding obligations under the Unsecured Convertible Note. The amount of the increase ranges from 5% to 15% depending on the type of default (as defined in the Unsecured Convertible Note). In addition, the Unsecured Convertible Note obligations will be increased if there are delays in the Company’s delivery requirements for the shares or cash issuable upon the conversion or redemption of the Unsecured Convertible Note in certain circumstances. If the Company issues convertible debt in the future with any terms, including conversion terms, that are more favorable to the terms of the Unsecured Convertible Note, the Convertible Noteholder may elect to incorporate the more favorable terms into the Unsecured Convertible Note. |
LICENSE AGREEMENTS
LICENSE AGREEMENTS | 3 Months Ended |
Mar. 31, 2019 | |
Disclosure Of License Agreements [Abstract] | |
License Agreements | LICENSE AGREEMENTS During 2016, the Company entered into a license agreement (the “Alba License”) with Alba Therapeutics Corporation (“Alba”) to obtain the rights to certain intellectual property relating to larazotide acetate and related compounds. The Company’s initial area of focus for these assets relates to the treatment of celiac disease. These assets are now referred to as INN-202 by the Company. Upon execution of the Alba License, the Company paid Alba a non-refundable license fee of $0.5 million . In addition, the Company is required to make milestone payments to Alba upon the achievement of certain clinical and regulatory milestones totaling up to $1.5 million and payments upon regulatory approval and commercial sales of a licensed product totaling up to $150 million , which is based on sales ranging from $100 million to $1.5 billion . Upon the Company paying Alba $2.5 million for the first commercial sale of a licensed product, the Alba License becomes perpetual and irrevocable. Upon the achievement of net sales in a year exceeding $ 1.5 billion , the Alba License also becomes free of milestone fees. The Alba License provides Alba with certain termination rights, including failure of the Company to use Commercially Reasonable Efforts to develop the licensed products. During 2013, the Company entered into an exclusive license agreement with Seachaid Pharmaceuticals, Inc. (the “Seachaid Agreement”) to further develop and commercialize the licensed product, the compound known as APAZA. This product is now referred to as INN-108 by the Company. The agreement shall continue in effect on a country-by-country basis, unless terminated sooner in accordance with the termination provisions of the agreement, until the expiration of the royalty term for such product and such country. The royalty term for each such product and such country shall continue until the earlier of the expiration of certain patent rights (as defined in the agreement) or the date that the sales for one or more generic equivalents makes up a certain percentage of sales in an applicable country during a calendar year. The Company was required to make an initial, non-refundable payment under the Seachaid Agreement in the amount of $0.2 million . The agreement also calls for milestone payments totaling up to $6.0 million to be paid when certain clinical and regulatory milestones are met. There are also commercialization milestone payments ranging from $1.0 million to $2.5 million depending on net sales of the products in a single calendar year, followed by royalty payments in the single digits based on net product sales. During 2014, the Company entered into an Asset Purchase Agreement with Repligen Corporation (“Repligen”) to acquire Repligen’s RG-1068 program for the development of Secretin for the Pancreatic Imaging Market and Magnetic Resonance Cholangiopancreatography. This program is now referred to as INN-329 by the Company. As consideration for the Asset Purchase Agreement, the Company agreed to make a non-refundable cash payment on the date of the agreement and future royalty payments consisting of a percentage between five and fifteen of annual net sales, with the royalty payment percentage increasing as annual net sales increase. The royalty payments are made on a product-by-product and country-by-country basis and the obligation to make the payments expires with respect to each country upon the later of (i) the expiration of regulatory exclusivity for the product in that country or (ii) 10 years after the first commercial sale in that country. The royalty amount is subject to reduction in certain situations, such as the entry of generic competition in the market. There were no milestone or royalty fees incurred during the three months ended March 31, 2019 and 2018. |
STOCKHOLDERS_ EQUITY
STOCKHOLDERS’ EQUITY | 3 Months Ended |
Mar. 31, 2019 | |
Equity [Abstract] | |
Stockholders' Equity | STOCKHOLDERS’ EQUITY The Company’s authorized capital stock consists of 360 million shares of capital stock, par value $0.0001 per share, of which 350 million shares are designated as common stock and 10 million shares are designated as preferred stock. The holders of the Company’s common stock (i) have equal ratable rights to dividends from funds legally available, therefore, when, as and if declared by the Company’s board of directors; (ii) are entitled to share in all the Company’s assets available for distribution to holders of common stock upon liquidation, dissolution or winding up of the Company’s affairs; (iii) do not have preemptive, subscription or conversion rights and there are no redemption or sinking fund provisions or rights; and (iv) are entitled to one non-cumulative vote per share on all matters on which stockholders may vote. The Company had reserved shares of common stock for future issuance as follows: March 31, December 31, 2019 2018 Outstanding stock options 7,182,002 7,117,002 Warrants to purchase common stock 8,604,018 1,914,316 Shares issuable upon conversion of convertible debt 1,703,120 1,720,224 For possible future issuance under the Amended Omnibus Plan 3,379,498 2,230,057 Total common shares reserved for future issuance 20,868,638 12,981,599 On March 17, 2019, the Company entered into the Purchase Agreement with SDS Capital Partners II, LLC and certain other accredited investors pursuant to which the Company sold 4,181,068 shares of common stock and issued Short-Term Warrants and Long-Term Warrants to purchase up to 6,689,702 shares of common stock. For further details, see Note 1—Summary of Significant Accounting Policies. On October 26, 2018, the Company entered into a common stock sales agreement with H.C. Wainwright & Co., LLC and Ladenburg Thalmann & Co., Inc. and filed a prospectus with the SEC to such offering. The Company previously filed a Form S-3 that became effective July 13, 2018 that included the registration of $40 million of its shares of common stock in connection with a potential “at-the-market (“ATM”) offering. Pursuant to the sales agreement, the Company may issue and sell shares having an aggregate gross sales price of up to $40 million . The Company will pay the sales agents commissions of 3% of the gross sales price per share sold. During the three months ended March 31, 2019, the Company sold 705,714 shares under the ATM for total net proceeds of approximately $1,675,000 . All proceeds were received as of March 31, 2019. |
SHARE-BASED COMPENSATION
SHARE-BASED COMPENSATION | 3 Months Ended |
Mar. 31, 2019 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Share-Based Compensation | SHARE-BASED COMPENSATION Upon consummation of the Merger, the Company had two stock option plans in existence: the Monster Digital, Inc. 2012 Omnibus Incentive Plan (the “Omnibus Plan”) and the Innovate 2015 Stock Incentive Plan (the “Private Innovate Plan”). During 2018, the Company’s board of directors approved an amendment to the Omnibus Plan to, among other things, formally change the name of the Omnibus Plan to the Innovate Biopharmaceuticals, Inc. 2012 Omnibus Incentive Plan (the “Amended Omnibus Plan”) and increase the number of shares authorized for issuance under the Amended Omnibus Plan to provide for an additional 3,000,000 shares. In addition, the shares reserved for issuance under the Amended Omnibus Plan will automatically increase on the first day of each calendar year beginning in 2019 and ending in 2022 by an amount equal to the lesser of (i) five percent of the number of shares of common stock outstanding as of December 31st of the immediately preceding calendar year or (ii) such lesser number of shares of common stock as determined by the board of directors (the “Evergreen Provision”). On January 1, 2019, the number of shares of common stock available under the Amended Omnibus Plan automatically increased by 1,304,441 shares pursuant to the Evergreen Provision. The terms of the option agreements are determined by the Company’s board of directors. The Company’s stock options vest based on the terms in the stock option agreements and typically vest over a period of three to four years . These stock options typically have a maximum term of ten years. Private Innovate Plan As of March 31, 2019 , there were 6,340,871 stock options outstanding under the Private Innovate Plan. Following completion of the Merger, the Company does not intend to issue any additional awards from the Private Innovate Plan. The range of assumptions used in estimating the fair value of the options granted or re-measured under the Private Innovate Plan using the Black-Scholes option pricing model for the periods presented were as follows: Three Months Ended 2019 2018 Expected dividend yield 0% 0% Expected stock-price volatility 67% 68% - 72% Risk-free interest rate 2.6% 2.7% - 2.9% Expected term of options 8.2 - 8.7 9.0 - 9.5 The following table summarizes stock option activity under the Private Innovate Plan: Number of Shares Weighted-Average Exercise Price Aggregate Intrinsic Value Weighted-Average Remaining Contractual Life (in years) Outstanding at December 31, 2018 6,340,871 $ 1.53 $ 6,617,433 7.7 Options granted — — — Options forfeited — — — Options exercised — — — Outstanding at March 31, 2019 6,340,871 1.53 3,315,876 6.2 Exercisable at March 31, 2019 5,664,831 1.45 3,315,876 5.9 Vested and expected to vest at March 31, 2019 6,309,322 $ 1.52 $ 3,315,876 6.2 There were no options granted or options exercised under the Private Innovate Plan during the three months ended March 31, 2019 and 2018. The total fair value of stock option awards vested during the three months ended March 31, 2019 under the Private Innovate Plan was approximately $145,000 . As of March 31, 2019 , there was approximately $0.9 million of total unrecognized compensation cost related to unvested stock-based compensation arrangements under the Private Innovate Plan, which is expected to be recognized over a weighted average period of 2 years. The Private Innovate Plan provides for accelerated vesting under certain change-of-control transactions, if approved by the Company’s board of directors. Amended Omnibus Plan As of March 31, 2019 , there were options to purchase 841,131 shares of Innovate common stock outstanding under the Amended Omnibus Plan and 3,379,498 shares available for future grants under the Amended Omnibus Plan. The range of assumptions used in estimating the fair value of the options granted or re-measured under the Amended Omnibus Plan using the Black-Scholes option pricing model for the periods presented were as follows: Three Months Ended 2019 Expected dividend yield 0% Expected stock-price volatility 68% – 72% Risk-free interest rate 2.5% – 2.7% Expected term of options 5.4 – 10.0 The following table summarizes stock option activity under the Amended Omnibus Plan: Number of Shares Weighted-Average Exercise Price Aggregate Intrinsic Value Weighted-Average Remaining Contractual Life (in years) Outstanding at December 31, 2018 776,131 $ 5.79 $ — 7.4 Options granted 65,000 2.04 — Options forfeited — — — Options exercised — — — Outstanding at March 31, 2019 841,131 5.50 — 7.4 Exercisable at March 31, 2019 390,282 6.01 — 4.9 Vested and expected to vest at March 31, 2019 809,079 $ 5.51 $ — 7.3 The weighted-average grant date fair value of options granted under the Amended Omnibus Plan was $ 1.29 during the three months ended March 31, 2019 . There were no options granted under the Amended Omnibus Plan during the three months ended March 31, 2018 . The total fair value of stock option awards vested under the Amended Omnibus Plan was approximately $118,000 during the three months ended March 31, 2019. As of March 31, 2019 , there was approximately $0.9 million of total unrecognized compensation cost related to unvested stock-based compensation arrangements under the Amended Omnibus Plan. This cost is expected to be recognized over a weighted average period of 2.8 years. The Amended Omnibus Plan provides for accelerated vesting under certain change-of-control transactions, if approved by the Company’s board of directors. During the three months ended March 31, 2019 , the board approved grants of 90,000 RSUs, which vested immediately on the date of grant. The weighted-average fair value of RSUs granted during the period was $2.12 and the Company recognized share-based compensation expense for the RSUs of approximately $190,000 during the three months ended March 31, 2019. There were no RSUs granted during the three months ended March 31, 2018. Total share-based compensation expense recognized in the accompanying statements of operations was as follows: Three Months Ended 2019 2018 Research and development $ 92,000 $ 5,751,000 General and administrative 434,000 1,423,000 Total share-based compensation $ 526,000 $ 7,174,000 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 3 Months Ended |
Mar. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | COMMITMENTS AND CONTINGENCIES Clinical Trial Agreement From time to time, the Company enters into agreements with contract research organizations and other service providers. In August 2018, the Company entered into such an agreement for its planned Phase 3 trial for the treatment of celiac disease. Under this agreement, the Company expects to pay approximately $1.1 million for data management over the course of the Phase 3 celiac disease trial for data management and biostatistics services. Employment Agreements Prior to March 11, 2018, the Company was party to employment agreements with certain executives of the Company. Under the terms of these agreements, the Company agreed to pay the executives certain payments upon the achievement of financial milestone events. These milestone events were based on total debt or equity funding received by the Company. During the three months ended March 31, 2018 , financial milestone events were achieved through the Merger and Equity Issuance events and the Company paid these executives approximately $1.1 million in accordance with the agreements. On March 11, 2018, the Company entered into amended and restated executive employment agreements with the executives and new executive employment agreements with certain new executives (the “Executive Agreements”). The Executive Agreements provide an annual base salary and the opportunity to participate in the Company’s equity compensation, employee benefit and bonus plans once they are established and approved by the Company’s board of directors. The Executive Agreements contain severance provisions if the executives are terminated under certain conditions that would provide the executive with 12 months of their base salary and up to 12 months of continuation of health insurance benefits. In November 2018 and February 2019, the Company entered into separation and general release agreements with two former executives of the Company that included separation benefits consistent with each former executives’ employment agreement. The Company recognized severance expense totaling $300,000 during the three months ended March 31, 2019, which is being paid in equal installments over 12 months beginning February 2019. The remaining accrued severance obligation in respect of the two former executives is $0.5 million as of March 31, 2019, which is included in accrued expenses on the accompanying condensed balance sheet. Office Lease In October 2017, the Company entered into a three -year lease for office space that expires on September 30, 2020 . Base annual rent is $60,000 , or $5,000 per month. The first two months of rent were paid in advance upon lease signing and the next ten months of rent were paid in advance on November 30, 2017. Beginning in October 2018, monthly payments of $5,000 are due and payable over the remaining 24 -month term. A security deposit of $5,000 was paid in October 2017. The lease contains a two -year renewal option. Effective January 1, 2019, the Company adopted ASC 842 using the transition approach described in Note 1—Summary of Significant Accounting Policies. On the adoption date, the Company estimated the present value of the lease payments over the remaining term of the lease using a discount rate of 12% , which represented the Company’s estimated incremental borrowing rate. The two -year renewal option was excluded from the lease payments as the Company concluded the exercise of this option was not considered reasonably certain. Operating lease cost under ASC 842 was approximately $ $15,000 for the three months ended March 31, 2019 and is included in general and administrative expenses on the accompanying condensed statement of operations and comprehensive loss. Lease expense under ASC 840 was less than $15,000 for the three months ended March 31, 2018 and is included in general and administrative expenses on the accompanying condensed statement of operations and comprehensive loss. The total cash paid for amounts included in the measurement of the operating lease liability and reported within operating activities was less than $0.1 million during the three months ended March 31, 2019. Future minimum payments under the Company’s lease liability were as follows: Year ended December 31, Operating Leases 2019 $ 45,000 2020 45,000 Total lease payment 90,000 Less: imputed interest (8,008 ) Total $ 81,992 Legal In November 2018, the Company received a letter and draft complaint regarding a former consultant of the Company who was compensated in cash and stock options for his services, demanding damages of up to approximately $3.6 million plus punitive damages in connection with a delay in such consultant’s ability and timing to exercise options and sell shares of the Company’s common stock related to past consulting services. On January 8, 2019, M. Scott Harris and Middleburg Consultants, Inc. (collectively, “Harris”) filed the claim in the Superior Court of the State of Delaware (the “Delaware Action”). As previously disclosed, the Company strongly denies any wrongdoing alleged in the threatened litigation and firmly believes the allegations in the complaint are entirely without merit and intends to defend against them vigorously. On February 25, 2019, the Company filed a motion to dismiss the Delaware Action. If the motion is not granted, the Company intends to dispute the factual basis of Harris’ claims and also intends to assert affirmative defenses and counterclaims against Harris. The motion to dismiss is scheduled to be heard by the Delaware court on May 31, 2019. The Company is unable to estimate the amount of a potential loss or range of potential loss, if any. From time to time, the Company could become involved in disputes and various litigation matters that arise in the normal course of business. These may include disputes and lawsuits related to intellectual property, licensing, contract law and employee relations matters. Periodically, the Company reviews the status of significant matters, if any exist, and assesses its potential financial exposure. If the potential loss from any claim or legal claim is considered probable and the amount can be estimated, the Company accrues a liability for the estimated loss. Legal proceedings are subject to uncertainties, and the outcomes are difficult to predict; therefore, accruals are based on the best information available at the time. As additional information becomes available, the Company reassesses the potential liability related to pending claims and litigation. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 3 Months Ended |
Mar. 31, 2019 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | SUBSEQUENT EVENTS Additional Issuance of Warrants On April 25, 2019, the Company entered into an amendment (the “Amendment”) to the Purchase Agreement dated as of March 17, 2019, further described in Note 1—Summary of Significant Accounting Policies, between the Company and each purchaser party thereto. The Amendment (i) deletes Section 4.12 of the Purchase Agreement, which generally prohibited the Company from issuing, entering into agreements to issue, announcing proposed issuances, selling or granting certain securities between the date of the Purchase Agreement and the date that is 45 days following the closing date thereunder and (ii) gives each purchaser the right to purchase, for $0.125 per underlying share, an additional warrant to purchase shares of the Company’s common stock having an exercise price per share of $2.13 and otherwise having the terms of the Long-Term Warrants (collectively, the “New Warrants”) pursuant to a securities purchase agreement to be entered into among the Company and each purchaser that desires to purchase the New Warrants. Each purchaser executing the securities purchase agreement will receive a New Warrant for up to that number of shares of common stock indicated in the securities purchase agreement which cannot exceed its pro rata portion (based on the number of shares of common stock it purchased pursuant to the Purchase Agreement, and rounded down to the nearest whole share) of the maximum number of shares of the Company’s common stock underlying the New Warrants that may be issued (approximately 3.9 million ) as provided in the securities purchase agreement. The number of New Warrants, if any, to be issued, and the number of shares underlying any such New Warrants, will be determined upon entry into the securities purchase agreement. Pursuant to the securities purchase agreement, the Company is required to file a registration statement for resale of the shares underlying the New Warrants by June 17, 2019. The New Warrants are exercisable for five years beginning on the six months anniversary of the date of issuance. The New Warrants have an initial exercise price equal to $2.13 per share, subject to certain adjustments. If not previously exercised in full, at the expiration of their applicable terms, the New Warrants will be automatically exercised via cashless exercise, in which case the holder would receive upon such exercise the net number of shares, if any, of common stock determined according to the formula set forth in the New Warrant. April 2019 Offering On April 29, 2019, the Company entered into a Securities Purchase Agreement (the “April Purchase Agreement”) with certain institutional and accredited investors providing for the sale by the Company of up to 4,318,272 shares of its common stock at a purchase price of $2.025 per share. Pursuant to the April Purchase Agreement, the Company agreed to issue unregistered warrants (the “Warrants”) to purchase up to 4,318,272 shares of common stock. Subject to certain ownership limitations, the Warrants are exercisable beginning on the date of their issuance until the five and a half year anniversary of their date of issuance at an initial exercise price of $2.13 . The exercise price of the Warrants will be subject to adjustment for stock splits, reverse splits, and similar capital transactions as described in the Warrants. Upon a fundamental transaction, the holder shall have the right to receive payment in cash, or under certain circumstances in other consideration, from the Company at the Black-Scholes value as described in the Warrants. The Warrants may be exercisable on a “cashless” basis while there is no effective registration statement or current prospectus available for the shares of common stock issuable upon exercise of the Warrants. A holder will not have the right to exercise any portion of the Warrant if the holder (together with its affiliates) would beneficially own in excess of 4.99% (or, at the election of the holder, 9.99% ) of the number of shares of common stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the Warrants. However, any holder may increase or decrease such percentage to any other percentage not in excess of 9.99% upon notice to the Company, provided that any increase in such percentage shall not be effective until 61 days after such notice. If not previously exercised in full, at the expiration of their terms, the Warrants will be automatically exercised via cashless exercise. The net proceeds from the offering and the private placement are approximately $7.9 million , after deducting commissions and estimated offering costs. The Company granted the placement agent warrants to purchase up to 215,914 shares of common stock (the “Placement Agent Warrants”). The Placement Agent Warrants have substantially the same terms as the Warrants, except that the Placement Agent Warrants will have an exercise price of $2.66 and will have a term of 5 years from the effective date of the offering. The Company will also pay the placement agent a reimbursement for non-accountable expenses in the amount of $35,000 and a reimbursement for legal fees and expenses of the placement agent in the amount of $25,000 . |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Basis of Accounting | Basis of Presentation The unaudited condensed interim financial statements have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial reporting. These financial statements are unaudited and, in the opinion of management, include all adjustments (consisting of normal recurring adjustments and accruals) necessary for a fair statement of the balance sheets, operating results, and cash flows for the periods presented in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). Operating results for the three months ended March 31, 2019 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2019 . Certain information and footnote disclosure normally included in the annual financial statements prepared in accordance with U.S. GAAP have been omitted in accordance with the SEC’s rules and regulations for interim reporting. The Company’s financial position, results of operations and cash flows are presented in U.S. Dollars. Upon the closing of the Merger, the outstanding shares of Private Innovate were exchanged for shares of common stock of Monster at an exchange ratio of one share of Private Innovate common stock to 0.37686604 shares of Monster common stock (the “Exchange Ratio”). All common share amounts and per share amounts have been adjusted to reflect this Exchange Ratio, which was effected upon the Merger. The Merger has been accounted for as a reverse recapitalization. Prior to the Merger, Monster spun-out all of its pre-merger business assets and liabilities before it acquired Private Innovate. The owners and management of Private Innovate have actual or effective voting and operating control of the combined company. In the Merger transaction, Monster is the accounting acquiree and Private Innovate is the accounting acquirer. A reverse recapitalization is equivalent to the issuance of stock by the private operating company for the net monetary assets of the accounting acquiree accompanied by a recapitalization with accounting similar to that resulting from a reverse acquisition, except that no goodwill or intangible assets are recorded. Immediately prior to the effective time of the Merger, Monster effected a reverse stock split at a ratio of one new share for every ten shares of its common stock outstanding. In connection with the Merger, 1,864,808 shares of the Company’s common stock were transferred to the existing Monster stockholders and the Company assumed approximately $1.0 million in liabilities from Monster for certain transaction costs and tail insurance coverage for its directors and officers, which were recorded as a reduction of additional paid-in capital. In addition, warrants to purchase up to 154,403 shares of the Company’s common stock remained outstanding after completion of the Merger. These warrants have a weighted-average exercise price of $55.31 per share and expire in 2021 and 2022 . The accompanying unaudited financial statements and related notes reflect the historical results of Private Innovate prior to the Merger and of the combined company following the Merger, and do not include the historical results of Monster prior to the completion of the Merger. These financial statements and related notes should be read in conjunction with the audited financial statements and related notes thereto for the year ended December 31, 2018 , included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018 , filed with the SEC on March 18, 2019. Except as noted below under the section entitled “Recently Issued Accounting Standards—Accounting Pronouncements Adopted”, there have been no material changes to the Company’s significant accounting policies during the three months ended March 31, 2019 , as compared to the significant accounting policies disclosed in Note 1 of the Company’s financial statements for the years ended December 31, 2018 and 2017 . However, the following accounting policies are the most critical in fully understanding the Company’s financial condition and results of operations. |
Business Risks | Business Risks The Company faces risks associated with biopharmaceutical companies whose products are in the early stages of development. These risks include, among others, the Company’s need for additional financing to achieve key development milestones, the need to defend intellectual property rights, and the dependence on key members of management. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and disclosures made in the accompanying notes to the financial statements. Areas of the financial statements where estimates may have the most significant effect include accrued expenses, share-based compensation, valuation of the derivative liability and warrant liability, valuation allowance for income tax assets and management’s assessment of the Company’s ability to continue as a going concern. Changes in the facts or circumstances underlying these estimates could result in material changes and actual results could differ from these estimates. |
Accrued Expenses | Accrued Expenses The Company incurs periodic expenses such as research and development, licensing fees, salaries and benefits, and professional fees. The Company is required to estimate its expenses resulting from obligations under contracts with clinical research organizations, vendors and consulting agreements that have been incurred by the Company prior to being invoiced. This process involves reviewing quotations and contracts, identifying services that have been performed on the Company’s behalf and estimating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of the actual cost. The majority of the Company’s service providers invoice monthly in arrears for services performed or when contractual milestones are met. The Company estimates accrued expenses as of each balance sheet date based on facts and circumstances known at that time. |
Derivative Liability | Derivative Liability The Company accounts for derivative instruments in accordance with Accounting Standards Codification (“ASC”) 815, Derivative and Hedging, which establishes accounting and reporting standards for derivative instruments, including certain derivative instruments embedded in other financial instruments or contracts and requires recognition of all derivatives on the balance sheet at fair value. The Company’s derivative financial instrument consists of an embedded option in the Company’s convertible debt. The embedded derivative includes provisions that provide the noteholder with certain conversion and put rights at various conversion or redemption values as well as certain call options for the Company. See Note 4—Debt for further details. |
Warrant Liabilities | Warrant Liabilities The Company’s Short-Term Warrants and Long-Term Warrants are freestanding financial instruments that contain net settlement options and may require the Company to settle these warrants in cash under certain circumstances. As such, the Company has classified these warrants as liabilities on the accompanying condensed balance sheets in accordance with ASC 840, Distinguishing Liabilities from Equity . The warrant liabilities are initially recorded at fair value on the date of grant and will be subsequently remeasured to fair value at each balance sheet date until the warrant liabilities are settled. Changes in the fair value of the warrants are recognized as a non-cash component of other income and expense in the accompanying condensed statements of operations and comprehensive loss. |
Research and Development | Research and Development Research and development expenses consist of costs incurred to further the Company’s research and development activities and include salaries and related employee benefits, manufacturing of pharmaceutical active ingredients and drug products, costs associated with clinical trials, nonclinical activities, regulatory activities, research-related overhead expenses and fees paid to expert consultants, external service providers and contract research organizations which conduct certain research and development activities on behalf of the Company. Costs incurred in the research and development of products are charged to research and development expense as incurred. Costs for preclinical studies and clinical trial activities are recognized based on an evaluation of the vendors’ progress towards completion of specific tasks, using data such as patient enrollment, clinical site activations or information provided by vendors regarding their actual costs incurred. Payments for these activities are based on the terms of individual contracts and payment timing may differ significantly from the period in which the services were performed. The Company determines accrual estimates through reports from and discussions with applicable personnel and outside service providers as to the progress or state of completion of trials, or the services completed. The estimates of accrued expenses as of each balance sheet date are based on the facts and circumstances known at the time. Although the Company does not expect its estimates to be materially different from amounts incurred, the Company’s estimates and assumptions for clinical trial costs could differ significantly from actual costs incurred, which could result in increases or decreases in research and development expenses in future periods when actual results are known. Nonrefundable advance payments for goods and services that will be used in future research and development activities are expensed when the goods have been received or when the activity is performed, rather than when payment is made. |
Share-based Compensation | Share-Based Compensation The Company recognizes share-based compensation expense for grants of stock options to employees and non-employee members of the Company’s board of directors based on the grant-date fair value of those awards using the Black-Scholes option-pricing model. Share-based compensation expense is generally recognized on a straight-line basis over the requisite service period for awards expected to vest. Prior to adoption of Accounting Standards Update (“ASU”) 2018-07, Compensation-Stock Compensation (Topic 718): Improvements to Non-employee Share-Based Payment Accounting , share-based compensation expense related to stock options granted to non-employees, other than non-employee directors, was adjusted each reporting period for changes in the fair value of the Company’s stock until the measurement date. The measurement date was generally considered to be the date when all services had been rendered or the date that options were fully vested. Effective January 1, 2019, the Company adopted ASU 2018-07, which no longer requires the re-measurement of the fair value for stock options awarded to non-employees. ASU 2018-07 expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from non-employees. Share-based compensation expense for both employees and non-employees includes an estimate, which is made at the time of grant, of the number of awards that are expected to be forfeited. This estimate is revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Under the Black-Scholes option-pricing model, fair value is calculated based on assumptions with respect to: • Expected dividend yield. The expected dividend yield is assumed to be zero as the Company has never paid dividends and has no current plans to pay any dividends on the Company’s common stock. • Expected stock-price volatility. Due to limited trading history as a public company, the expected volatility is derived from the average historical volatilities of publicly traded companies within the Company’s industry that the Company considers to be comparable to the Company’s business over a period approximately equal to the expected term. In evaluating comparable companies, the Company considers factors such as industry, stage of life cycle, financial leverage, size and risk profile. • Risk-free interest rate. The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of grant for zero coupon U.S. Treasury notes with maturities approximately equal to the expected term. • Expected term. The expected term represents the period that the stock-based awards are expected to be outstanding. Due to limited history of stock option exercises, the Company estimates the expected term of employee stock options based on the simplified method, which calculates the expected term as the average of the time-to-vesting and the contractual life of the options. Pursuant to ASU-2018-07, the Company has elected to use the contractual life of the option as the expected term for non-employee options. Periodically, the board may approve the grant of restricted stock units (“RSUs”), pursuant to the Innovate Biopharmaceuticals, Inc. 2012 Omnibus Incentive Plan, as amended, which represent the right to receive shares of the Company’s common stock based on terms of the agreement. The fair value of RSUs is recognized as share-based compensation expense generally on a straight-line basis over the service period, net of estimated forfeitures. The grant date fair value of an RSU represents the closing price of the Company’s common stock on the date of grant. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Fair value is defined as the price that would be received for sale of an asset or paid for transfer of a liability, in an orderly transaction between market participants at the measurement date. U.S. GAAP establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). Financial instruments recorded in the accompanying condensed balance sheets are categorized based on the inputs to valuation techniques as follows: • Level 1 - defined as observable inputs based on unadjusted quoted prices for identical instruments in active markets; • Level 2 - defined as inputs other than Level 1 that are either directly or indirectly observable in the marketplace for identical or similar instruments in markets that are not active; and • Level 3 - defined as unobservable inputs in which little or no market data exists where valuations are derived from techniques in which one or more significant inputs are unobservable. The fair value of the embedded derivative issued in connection with the Senior Convertible Note and the Unsecured Convertible Note, further described in Note 4—Debt, was determined by using a Monte Carlo simulation technique (“MCS”) to value the embedded derivative associated with each note. As part of the MCS valuation, a discounted cash flow (“DCF”) model is used to value the debt on a stand-alone basis and determine the discount rate to utilize in both the DCF and MCS models. The significant estimates used in the DCF model include the time to maturity of the convertible debt and calculated discount rate, which includes an estimate of the Company’s specific risk premium. The MCS methodology calculates the theoretical value of an option based on certain parameters, including: (i) the threshold of exercising the option, (ii) the price of the underlying security, (iii) the time to expiration, or expected term, (iv) the expected volatility of the underlying security, (v) the risk-free rate and (vi) the number of paths. These valuation techniques involve management’s estimates and judgment based on unobservable inputs and are classified in Level 3. The table below summarizes the valuation inputs into the MCS model for the derivative liability associated with the Senior Convertible Note as of December 31, 2018 and for the derivative liability associated with the Unsecured Convertible Note as of March 8, 2019 and March 31, 2019. Derivative Liability March 31, March 8, December 31, 2019 2019 2018 Expected dividend yield Discount rate 29.0 % 29.3 % 13.6 % Expected stock price volatility 100.3 % 101.1 % 105.6 % Risk-free interest rate 2.5 % 2.5 % 2.5 % Expected term 23 months 24 months 21 months Price of the underlying common stock $ 1.93 $ 1.99 $ 2.31 The fair value of the warrants issued with the Purchase Agreement further described above in the section entitled “March 2019 Offering,” were determined through the use of an MCS model. The MCS methodology calculates the theoretical value of an option based on certain parameters, including (i) the threshold of exercising the option, (ii) the price of the underlying security, (iii) the time to expiration, or expected term, (iv) the expected volatility of the underlying security, (v) the risk-free interest rate and (vi) the number of paths. Given the high level of the selected volatilities, the methodology selected simulates the Company’s market value of invested capital (“MVIC”) through the maturity date of the respective warrants (one year for the Short-Term Warrants and five years for the Long-Term Warrants). Further, the estimated future stock price of the Company is calculated by subtracting the debt plus accrued interest from the MVIC. The significant estimates used in the MCS model include management’s estimated probability of future financing and liquidation events. These valuation techniques involve management’s estimates and judgment based on unobservable inputs and are classified in Level 3. The table below summarizes the valuation inputs into the MCS model for the warrant liabilities on the date of issuance and period end as of March 18, 2019 and March 31, 2019, respectively. Short-Term Warrants Long-Term Warrants March 31, 2019 March 18, 2019 March 31, 2019 March 18, 2019 Conversion price $ 4.00 $ 4.00 $ 2.56 $ 2.56 Expected stock price volatility 123.8 % 122.0 % 85.4 % 85.2 % Risk-free interest rate 2.4 % 2.5 % 2.4 % 2.2 % Expected term 1 year 1 year 5 years 5 years Price of the underlying common stock $ 1.93 $ 2.48 1.93 $ 2.48 The following table summarizes the fair value hierarchy of financial liabilities measured at fair value as of March 31, 2019 and December 31, 2018. March 31, 2019 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Derivative liability $ — $ — $ 1,180,000 $ 1,180,000 Warrant liability — — 1,113,000 1,113,000 Total liabilities at fair value $ — $ — $ 2,293,000 $ 2,293,000 December 31, 2018 Quoted Prices in Active Markets for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs Total Derivative liability $ — $ — $ 370,000 $ 370,000 Warrant liability — — — — Total liabilities at fair value $ — $ — $ 370,000 $ 370,000 The following table summarizes the changes in fair value of the derivative liability and warrant liability classified in Level 3. Gains and losses reported in this table include changes in fair value that are attributable to unobservable inputs. Three Months Ended March 31, 2019 Beginning balance as of December 31, 2018 $ 370,000 Issuance of warrant liabilities in March 2019 Offering 1,970,000 Extinguishment of derivative liability (the Senior Convertible Note) (370,000 ) Issuance of derivative liability (the Unsecured Convertible Note) 1,281,000 Change in fair value of warrant liability (857,000 ) Change in fair value of derivative liability (101,000 ) Ending balance as of March 31, 2019 $ 2,293,000 The amount of total gain for the period included in earnings attributable to the change in unrealized gains relating to the fair value liabilities still held at the reporting date $ 958,000 There were no gains or losses included in earnings attributable to changes in unrealized gains or losses for fair value assets or liabilities during the three months ended March 31, 2018. The cumulative unrealized gain relating to the change in fair value of the derivative liability and warrant liabilities of $958,000 and the extinguishment of derivative liability of $370,000 for the three months ended March 31, 2019 is included in other expense in the condensed statements of operations and comprehensive loss. ASC 820, Fair Value Measurement and Disclosures requires all entities to disclose the fair value of financial instruments, both assets and liabilities, for which it is practicable to estimate fair value. As of March 31, 2019 and December 31, 2018, the recorded values of cash and cash equivalents, restricted deposit, accounts payable, accrued expenses and convertible promissory notes approximate their fair values due to the short-term nature of the instruments. |
Deferred Offering Costs | Deferred Offering Costs Deferred offering costs consist principally of legal, accounting and underwriters’ fees related to offerings or the Company’s shelf registration. Offering costs incurred prior to an offering are initially capitalized and then subsequently reclassified to additional paid-in capital upon completion of the offering. Deferred offering costs associated with the shelf registration will be charged to additional paid-in capital on a pro-rata basis in the event the Company completes an offering under the shelf registration. Offering costs incurred in the March 2019 Offering were charged to additional paid-in capital upon completion of the offering on March 18, 2019. |
Patent Costs | Patent Costs Costs associated with the submission of patent applications are expensed as incurred given the uncertainty of the future economic benefits of the patents. |
Earnings Per Share | Net Loss Per Share The Company calculates net loss per share as a measurement of the Company’s performance while giving effect to all potentially dilutive shares that were outstanding during the reporting period. Because the Company had a net loss for all periods presented, the inclusion of common stock options or other similar instruments would be anti-dilutive. Therefore, the weighted average shares outstanding used to calculate both basic and diluted net loss per share are the same. |
Segment Reporting | Segments Operating segments are defined as components of an enterprise engaging in business activities for which discrete financial information is available and regularly reviewed by the chief operating decision maker in deciding how to allocate resources and in assessing performance. The Company operates and manages its business as one operating segment and all of the Company’s operations are in North America. |
Accounting Pronouncements | Accounting Pronouncements Adopted The Company adopted ASU No. 2016-02, Leases (Topic 842) , as amended, as of January 1, 2019 using the modified retrospective approach at the beginning of the period of adoption. Under this approach, the reporting for comparative periods presented in the financial statements are presented in accordance with the legacy lease standard. In addition, the Company elected the available practical expedients permitted under the transition guidance within the new lease standard. Under the new leases standard, the Company recognizes a right-of-use (“ROU”) asset and lease liability upon commencement of a lease. The ROU represents the Company’s right to use an underlying asset for the lease term and is included in right-of-use asset on the accompanying condensed balance sheets. Lease liabilities represent the Company’s obligation to make lease payments arising from the lease and are included in current and non-current lease liability on the accompanying condensed balance sheets. Operating lease ROU assets and liabilities are recognized at the commencement date based on the present value of lease payments over the lease term. In the absence of an implicit rate, the Company uses their incremental borrowing rate based on the information available at the commencement date in determining the present value of lease payments. All leases with a term of less than 12 months are not recognized on the balance sheet. Adoption of the new leases standard resulted in the Company recognizing a ROU asset and lease liability of less than $0.1 million as of January 1, 2019. The adoption of ASU 2016-02 did not result in a cumulative adjustment to accumulated deficit. In June 2018, the FASB issued ASU 2018-07, Compensation-Stock Compensation (Topic 718): Improvements to Non-employee Share-Based Payment Accounting. ASU 2 018-07 expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from non-employees. The Company adopted this standard effective January 1, 2019. Effective January 1, 2019, the date of adoption, the Company changed its expense recognition for share-based payments to non-employees to an amount determined at the grant or modification date instead of a variable amount to be re-measured each reporting period. The Company calculated the fair value of its non-employee grants as of the adoption date and determined that there was no impact to the Company’s accumulated deficit or other components of equity upon adoption of ASU 2018-07. The unamortized expense for non-employee grants will be recognized on a straight-line basis over the remaining contractual term of the respective non-employee option agreements. The adoption of ASU 2018-07 did not have a material impact on the Company’s financial statements. Accounting Pronouncements Being Evaluated 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. This standard no longer requires public companies to disclose transfers between level 1 and 2 of the fair value hierarchy and adds additional disclosure requirements about the range and weighted average used to develop significant unobservable inputs for Level 3 fair value measurements. The guidance is effective for fiscal years beginning after December 15, 2019, and for interim periods within those fiscal years. Early adoption is permitted and the Company is currently evaluating the impact this standard will have on the Company’s financial statements. |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Schedule of Accrued Liabilities | Accrued expenses consisted of the following: March 31, 2019 December 31, 2018 Accrued compensation and benefits $ 659,352 $ 697,334 Other accrued expenses 237,903 128,993 Total $ 897,255 $ 826,327 |
Fair Value Measurement Inputs and Valuation Techniques | The table below summarizes the valuation inputs into the MCS model for the warrant liabilities on the date of issuance and period end as of March 18, 2019 and March 31, 2019, respectively. Short-Term Warrants Long-Term Warrants March 31, 2019 March 18, 2019 March 31, 2019 March 18, 2019 Conversion price $ 4.00 $ 4.00 $ 2.56 $ 2.56 Expected stock price volatility 123.8 % 122.0 % 85.4 % 85.2 % Risk-free interest rate 2.4 % 2.5 % 2.4 % 2.2 % Expected term 1 year 1 year 5 years 5 years Price of the underlying common stock $ 1.93 $ 2.48 1.93 $ 2.48 |
Fair Value, Assets Measured on Recurring and Nonrecurring Basis | The following table summarizes the fair value hierarchy of financial liabilities measured at fair value as of March 31, 2019 and December 31, 2018. March 31, 2019 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Derivative liability $ — $ — $ 1,180,000 $ 1,180,000 Warrant liability — — 1,113,000 1,113,000 Total liabilities at fair value $ — $ — $ 2,293,000 $ 2,293,000 December 31, 2018 Quoted Prices in Active Markets for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs Total Derivative liability $ — $ — $ 370,000 $ 370,000 Warrant liability — — — — Total liabilities at fair value $ — $ — $ 370,000 $ 370,000 |
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation | The following table summarizes the changes in fair value of the derivative liability and warrant liability classified in Level 3. Gains and losses reported in this table include changes in fair value that are attributable to unobservable inputs. Three Months Ended March 31, 2019 Beginning balance as of December 31, 2018 $ 370,000 Issuance of warrant liabilities in March 2019 Offering 1,970,000 Extinguishment of derivative liability (the Senior Convertible Note) (370,000 ) Issuance of derivative liability (the Unsecured Convertible Note) 1,281,000 Change in fair value of warrant liability (857,000 ) Change in fair value of derivative liability (101,000 ) Ending balance as of March 31, 2019 $ 2,293,000 The amount of total gain for the period included in earnings attributable to the change in unrealized gains relating to the fair value liabilities still held at the reporting date $ 958,000 |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The potentially dilutive securities consisted of the following: Three Months Ended 2019 2018 Options outstanding under the Private Innovate Plan 6,340,871 6,547,288 Options outstanding under the Amended Omnibus Plan 841,131 1,683 Warrants issued at a weighted-average exercise price of $55.31 154,403 154,403 Warrants issued at an exercise price of $2.54 349,555 349,555 Warrants issued at an exercise price of $3.18 1,410,358 1,702,216 Short-term warrants issued at an exercise price of $4.00 4,181,068 — Long-term warrants issued at an exercise price of $2.56 2,508,634 — Total 15,786,020 8,755,145 |
DEBT (Tables)
DEBT (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Debt Disclosure [Abstract] | |
Schedule of Debt | consists of the following: March 31, 2019 Convertible Note $ 5,500,000 Less: unamortized debt discount and OID accretion (1,763,197 ) Total $ 3,736,803 |
STOCKHOLDERS' EQUITY (Tables)
STOCKHOLDERS' EQUITY (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Equity [Abstract] | |
Schedule of Stock by Class | The Company had reserved shares of common stock for future issuance as follows: March 31, December 31, 2019 2018 Outstanding stock options 7,182,002 7,117,002 Warrants to purchase common stock 8,604,018 1,914,316 Shares issuable upon conversion of convertible debt 1,703,120 1,720,224 For possible future issuance under the Amended Omnibus Plan 3,379,498 2,230,057 Total common shares reserved for future issuance 20,868,638 12,981,599 |
SHARE-BASED COMPENSATION (Table
SHARE-BASED COMPENSATION (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions | The range of assumptions used in estimating the fair value of the options granted or re-measured under the Private Innovate Plan using the Black-Scholes option pricing model for the periods presented were as follows: Three Months Ended 2019 2018 Expected dividend yield 0% 0% Expected stock-price volatility 67% 68% - 72% Risk-free interest rate 2.6% 2.7% - 2.9% Expected term of options 8.2 - 8.7 9.0 - 9.5 The range of assumptions used in estimating the fair value of the options granted or re-measured under the Amended Omnibus Plan using the Black-Scholes option pricing model for the periods presented were as follows: Three Months Ended 2019 Expected dividend yield 0% Expected stock-price volatility 68% – 72% Risk-free interest rate 2.5% – 2.7% Expected term of options 5.4 – 10.0 |
Share-based Compensation, Activity | The following table summarizes stock option activity under the Amended Omnibus Plan: Number of Shares Weighted-Average Exercise Price Aggregate Intrinsic Value Weighted-Average Remaining Contractual Life (in years) Outstanding at December 31, 2018 776,131 $ 5.79 $ — 7.4 Options granted 65,000 2.04 — Options forfeited — — — Options exercised — — — Outstanding at March 31, 2019 841,131 5.50 — 7.4 Exercisable at March 31, 2019 390,282 6.01 — 4.9 Vested and expected to vest at March 31, 2019 809,079 $ 5.51 $ — 7.3 The following table summarizes stock option activity under the Private Innovate Plan: Number of Shares Weighted-Average Exercise Price Aggregate Intrinsic Value Weighted-Average Remaining Contractual Life (in years) Outstanding at December 31, 2018 6,340,871 $ 1.53 $ 6,617,433 7.7 Options granted — — — Options forfeited — — — Options exercised — — — Outstanding at March 31, 2019 6,340,871 1.53 3,315,876 6.2 Exercisable at March 31, 2019 5,664,831 1.45 3,315,876 5.9 Vested and expected to vest at March 31, 2019 6,309,322 $ 1.52 $ 3,315,876 6.2 |
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs | hare-based compensation expense recognized in the accompanying statements of operations was as follows: Three Months Ended 2019 2018 Research and development $ 92,000 $ 5,751,000 General and administrative 434,000 1,423,000 Total share-based compensation $ 526,000 $ 7,174,000 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Rental Payments for Operating Leases | Future minimum payments under the Company’s lease liability were as follows: Year ended December 31, Operating Leases 2019 $ 45,000 2020 45,000 Total lease payment 90,000 Less: imputed interest (8,008 ) Total $ 81,992 |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Narrative (Details) | Mar. 18, 2019USD ($)day$ / sharesshares | Mar. 15, 2018USD ($)shares | Jan. 29, 2018USD ($)$ / sharesshares | Mar. 31, 2019USD ($)segment$ / sharesshares | Mar. 31, 2018USD ($)shares | Jan. 29, 2019 | Jan. 01, 2019USD ($) | Jul. 13, 2018USD ($) |
Significant Accounting Policies Disclosure [Line Items] | ||||||||
Exchange ratio in connection with merger | 0.37686604 | |||||||
Class of warrant or right, outstanding (in shares) | 154,403 | |||||||
Sale of stock, shelf registration maximum equity offering price | $ | $ 175,000,000 | |||||||
Sale of stock, stockholders aggregate shares available-for-sale (in shares) | 13,990,403 | |||||||
Sale of stock, shares issuable upon exercise of warrant (in shares) | 2,051,771 | |||||||
Number of shares issued in transaction (in shares) | 4,181,068 | |||||||
Number of securities called by each warrant (in shares) | 6,689,702 | |||||||
Shares issued, price per share (in usd per share) | $ / shares | $ 2.33 | |||||||
Proceeds from issuance of common stock | $ | $ 9,700,000 | |||||||
Warrant term | 5 years | |||||||
Stock split, conversion ratio | 0.10 | |||||||
General and administrative expense | $ | $ 3,114,495 | $ 4,970,613 | ||||||
Antidilutive securities excluded from computation of earnings per share (in shares) | 15,786,020 | 8,755,145 | ||||||
Number of operating segments | segment | 1 | |||||||
Operating lease, right-of-use asset | $ | $ 81,992 | |||||||
Operating lease, liability | $ | 81,992 | |||||||
Patent Costs | ||||||||
Significant Accounting Policies Disclosure [Line Items] | ||||||||
General and administrative expense | $ | $ 161,000 | $ 130,000 | ||||||
Monster Digital, Inc | ||||||||
Significant Accounting Policies Disclosure [Line Items] | ||||||||
Equity interest issued or issuable (in shares) | 1,864,808 | |||||||
Liabilities assumed | $ | $ 1,000,000 | |||||||
Exercise price of warrants or rights (in usd per share) | $ / shares | $ 55.31 | |||||||
Accounting Standards Update 2016-02 | ||||||||
Significant Accounting Policies Disclosure [Line Items] | ||||||||
Operating lease, right-of-use asset | $ | $ 100,000 | |||||||
Operating lease, liability | $ | $ 100,000 | |||||||
At-the-Market Offering | ||||||||
Significant Accounting Policies Disclosure [Line Items] | ||||||||
Sale of stock, ATM maximum equity offering price | $ | $ 40,000,000 | |||||||
Number of shares issued in transaction (in shares) | 705,714 | |||||||
Private Innovate Plan, Warrants Exercised At $55.31 | Warrant | ||||||||
Significant Accounting Policies Disclosure [Line Items] | ||||||||
Exercise price of warrants or rights (in usd per share) | $ / shares | $ 55.31 | |||||||
Antidilutive securities excluded from computation of earnings per share (in shares) | 154,403 | 154,403 | ||||||
Long-term Warrants | ||||||||
Significant Accounting Policies Disclosure [Line Items] | ||||||||
Exercise price of warrants or rights (in usd per share) | $ / shares | $ 2.56 | |||||||
Number of securities called by each warrant (in shares) | 2,508,634 | |||||||
Warrant term | 5 years | |||||||
Long-term Warrants | Warrant | ||||||||
Significant Accounting Policies Disclosure [Line Items] | ||||||||
Exercise price of warrants or rights (in usd per share) | $ / shares | $ 2.56 | |||||||
Antidilutive securities excluded from computation of earnings per share (in shares) | 2,508,634 | 0 | ||||||
Short-term Warrants | ||||||||
Significant Accounting Policies Disclosure [Line Items] | ||||||||
Exercise price of warrants or rights (in usd per share) | $ / shares | $ 4 | |||||||
Number of securities called by each warrant (in shares) | 4,181,068 | |||||||
Warrant term | 1 year | |||||||
Threshold consecutive trading days | day | 10 | |||||||
Short-term Warrants | Warrant | ||||||||
Significant Accounting Policies Disclosure [Line Items] | ||||||||
Exercise price of warrants or rights (in usd per share) | $ / shares | $ 4 | |||||||
Antidilutive securities excluded from computation of earnings per share (in shares) | 4,181,068 | 0 | ||||||
Weighted Average | ||||||||
Significant Accounting Policies Disclosure [Line Items] | ||||||||
Common stock, exercise price per share (in usd per share) | $ / shares | $ 5.25 | |||||||
Overstatement of Share-based Compensation | ||||||||
Significant Accounting Policies Disclosure [Line Items] | ||||||||
Overstatement of share-based compensation expense | $ | $ 1,200,000 |
SUMMARY OF SIGNIFICANT ACCOUN_5
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Accrued Expenses (Details) - USD ($) | Mar. 31, 2019 | Dec. 31, 2018 |
Accounting Policies [Abstract] | ||
Accrued compensation and benefits | $ 659,352 | $ 697,334 |
Other accrued expenses | 237,903 | 128,993 |
Total | $ 897,255 | $ 826,327 |
SUMMARY OF SIGNIFICANT ACCOUN_6
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Summary of Valuation Input for Warrant and Derivative Liabilities (Details) | Mar. 31, 2019yearmonth$ / shares | Mar. 18, 2019year$ / shares | Mar. 08, 2019month$ / shares | Jan. 29, 2019 | Dec. 31, 2018month$ / shares |
Discount rate | |||||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||||
Derivative liability, measurement input | 0.290 | 0.293 | 0.136 | ||
Expected stock price volatility | |||||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||||
Derivative liability, measurement input | 1.003 | 1.011 | 1.056 | ||
Warrants and rights outstanding, measurement input | 0.848 | ||||
Expected stock price volatility | Short-term Warrants | |||||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||||
Warrants and rights outstanding, measurement input | 1.238 | 1.220 | |||
Expected stock price volatility | Long-term Warrants | |||||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||||
Warrants and rights outstanding, measurement input | 0.854 | 0.852 | |||
Risk-free interest rate | |||||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||||
Derivative liability, measurement input | 0.025 | 0.025 | 0.025 | ||
Warrants and rights outstanding, measurement input | 0.025 | ||||
Risk-free interest rate | Short-term Warrants | |||||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||||
Warrants and rights outstanding, measurement input | 0.024 | 0.025 | |||
Risk-free interest rate | Long-term Warrants | |||||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||||
Warrants and rights outstanding, measurement input | 0.024 | 0.022 | |||
Expected Term | |||||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||||
Derivative liability, measurement input | month | 23 | 24 | 21 | ||
Expected Term | Short-term Warrants | |||||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||||
Warrants and rights outstanding, measurement input | year | 1 | 1 | |||
Expected Term | Long-term Warrants | |||||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||||
Warrants and rights outstanding, measurement input | year | 5 | 5 | |||
Price of the underlying common stock | |||||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||||
Derivative liability, measurement input | 1.93 | 1.99 | 2.31 | ||
Price of the underlying common stock | Short-term Warrants | |||||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||||
Warrants and rights outstanding, measurement input | 1.93 | 2.48 | |||
Price of the underlying common stock | Long-term Warrants | |||||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||||
Warrants and rights outstanding, measurement input | 1.93 | 2.48 | |||
Conversion price | Short-term Warrants | |||||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||||
Warrants and rights outstanding, measurement input | 4 | 4 | |||
Conversion price | Long-term Warrants | |||||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||||
Warrants and rights outstanding, measurement input | 2.56 | 2.56 |
SUMMARY OF SIGNIFICANT ACCOUN_7
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Summary of Fair Value Hierarchy of Financial Liabilities Measured at Fair Value (Details) - Fair Value, Measurements, Recurring - USD ($) | Mar. 31, 2019 | Dec. 31, 2018 |
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Derivative liability | $ 1,180,000 | $ 370,000 |
Warrant liability | 1,113,000 | 0 |
Total liabilities at fair value | 2,293,000 | 370,000 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Derivative liability | 0 | 0 |
Warrant liability | 0 | 0 |
Total liabilities at fair value | 0 | 0 |
Significant Other Observable Inputs (Level 2) | ||
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Derivative liability | 0 | 0 |
Warrant liability | 0 | 0 |
Total liabilities at fair value | 0 | 0 |
Significant Unobservable Inputs (Level 3) | ||
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Derivative liability | 1,180,000 | 370,000 |
Warrant liability | 1,113,000 | 0 |
Total liabilities at fair value | $ 2,293,000 | $ 370,000 |
SUMMARY OF SIGNIFICANT ACCOUN_8
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Changes in Fair Value Derivative Liability (Details) | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Roll Forward] | |
Beginning balance of net derivative asset (liability) | $ 370,000 |
Ending balance of net derivative asset (liability) | 2,293,000 |
The amount of total gain for the period included in earnings attributable to the change in unrealized gains relating to the fair value liabilities still held at the reporting date | 958,000 |
Warrant | |
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Roll Forward] | |
Issuance | 1,970,000 |
Change in fair value | (857,000) |
Derivative Liability | |
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Roll Forward] | |
Issuance | 1,281,000 |
Extinguishment of derivative liability | (370,000) |
Change in fair value | $ (101,000) |
SUMMARY OF SIGNIFICANT ACCOUN_9
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Potential Dilutive Securities (Details) - $ / shares | 3 Months Ended | ||
Mar. 31, 2019 | Mar. 31, 2018 | Mar. 18, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share (in shares) | 15,786,020 | 8,755,145 | |
Short-term Warrants | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Exercise price of warrants or rights (in usd per share) | $ 4 | ||
Short-term Warrants | Warrant | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share (in shares) | 4,181,068 | 0 | |
Exercise price of warrants or rights (in usd per share) | $ 4 | ||
Long-term Warrants | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Exercise price of warrants or rights (in usd per share) | $ 2.56 | ||
Long-term Warrants | Warrant | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share (in shares) | 2,508,634 | 0 | |
Exercise price of warrants or rights (in usd per share) | $ 2.56 | ||
Private Innovate 2015 Stock Incentive Plan | Stock options | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share (in shares) | 6,340,871 | 6,547,288 | |
Omnibus Incentive Plan 2012 | Stock options | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share (in shares) | 841,131 | 1,683 | |
Private Innovate Plan, Warrants Exercised At $55.31 | Warrant | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share (in shares) | 154,403 | 154,403 | |
Exercise price of warrants or rights (in usd per share) | $ 55.31 | ||
Private Innovate Plan, Warrants Exercised At $2.54 | Warrant | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share (in shares) | 349,555 | 349,555 | |
Exercise price of warrants or rights (in usd per share) | $ 2.54 | ||
Private Innovate Plan, Warrants Exercised At $3.18 | Warrant | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share (in shares) | 1,410,358 | 1,702,216 | |
Exercise price of warrants or rights (in usd per share) | $ 3.18 |
MERGER AND FINANCING (Details)
MERGER AND FINANCING (Details) | 1 Months Ended | 3 Months Ended | |
Jan. 29, 2019USD ($)$ / sharesshares | Mar. 31, 2019USD ($) | Mar. 31, 2018USD ($) | |
Business Acquisition [Line Items] | |||
Proceeds from issuance of common stock | $ 18,100,000 | $ 11,475,255 | $ 18,132,661 |
Net proceeds from issuance of common stock after deducting stock issuance costs | 16,500,000 | ||
Placement agent fees | $ 1,600,000 | ||
Warrant term | 5 years | ||
Number of warrants issued (in shares) | shares | 1,400,000 | ||
Allocation of warrants to liabilities | $ 2,000,000 | 1,995,000 | |
Warrants issued to placement agents | $ 913,000 | $ 913,000 | |
Warrant | |||
Business Acquisition [Line Items] | |||
Exercise price of warrants or rights (in usd per share) | $ / shares | $ 3.18 | ||
Placement Agent | |||
Business Acquisition [Line Items] | |||
Warrant term | 5 years | ||
Number of warrants issued to placement agents (in shares) | shares | 349,555 | ||
Placement Agent | Warrant | |||
Business Acquisition [Line Items] | |||
Exercise price of warrants or rights (in usd per share) | $ / shares | $ 2.54 | ||
Affiliates | |||
Business Acquisition [Line Items] | |||
Warrant term | 5 years | ||
Number of warrants issued to affiliates (in shares) | shares | 279,862 | ||
Affiliates | Warrant | |||
Business Acquisition [Line Items] | |||
Exercise price of warrants or rights (in usd per share) | $ / shares | $ 3.18 | ||
Convertible Promissory Notes | |||
Business Acquisition [Line Items] | |||
Original debt amount | $ 8,600,000 | ||
Conversion price (in usd per share) | $ / shares | $ 0.72 | ||
Conversion discount percentage | 25.00% | ||
Beneficial conversion feature | $ 3,100,000 | ||
Accured Interest | |||
Business Acquisition [Line Items] | |||
Original debt amount | $ 582,000 | ||
Measurement Input, Expected Dividend Rate | |||
Business Acquisition [Line Items] | |||
Warrants and rights outstanding, measurement input | 0 | ||
Expected stock price volatility | |||
Business Acquisition [Line Items] | |||
Warrants and rights outstanding, measurement input | 0.848 | ||
Risk-free interest rate | |||
Business Acquisition [Line Items] | |||
Warrants and rights outstanding, measurement input | 0.025 |
DEBT - Senior Convertible Note
DEBT - Senior Convertible Note (Details) | Jan. 07, 2019USD ($) | Oct. 04, 2018USD ($) | Jan. 29, 2018USD ($) | Jan. 31, 2019USD ($) | Mar. 31, 2019USD ($) | Mar. 31, 2018USD ($) | Dec. 31, 2018day |
Debt Instrument [Line Items] | |||||||
Loss on extinguishment of debt | $ 1,049,166 | $ 0 | |||||
Amortization of debt discount | 74,803 | 427,866 | |||||
Note Purchase Agreement and Senior Note Payable | |||||||
Debt Instrument [Line Items] | |||||||
Note payable, gross | $ 4,800,000 | ||||||
Unamortized discount | 1,800,000 | ||||||
Financing costs | 20,000 | ||||||
Proceeds from notes payable | $ 3,000,000 | ||||||
Debt interest rate | 12.50% | ||||||
Amortization of debt discount | 0 | $ 400,000 | |||||
New Note | |||||||
Debt Instrument [Line Items] | |||||||
Financing costs | $ 30,000 | ||||||
Debt interest rate | 8.00% | ||||||
Principal amount | $ 5,200,000 | ||||||
Interest rate upon default | 18.00% | ||||||
Loss on extinguishment of debt | $ 0 | ||||||
Threshold consecutive trading days | day | 10 | ||||||
Repayments of short-term convertible debt | $ 1,049,167 | ||||||
Repayment of accrued interest convertible note payable | $ 1,399 | ||||||
Consideration paid to noteholder | $ 250,000 | ||||||
Convertible note option agreement purchase price | 5,200,000 | ||||||
Convertible note option accrued interest | $ 60,000 |
DEBT - Unsecured Convertible Pr
DEBT - Unsecured Convertible Promissory Note (Details) | Mar. 08, 2019USD ($)day$ / shares | Mar. 31, 2019USD ($) | Mar. 31, 2018USD ($) |
Short-term Debt [Line Items] | |||
Amortization of debt discount | $ 74,803 | $ 427,866 | |
Unsecured Convertible Promissory Note | |||
Short-term Debt [Line Items] | |||
Principal amount | 5,500,000 | ||
Conversion price (in usd per share) | $ / shares | $ 3.25 | ||
Redemption price, percentage | 115.00% | ||
Proceeds from notes payable | 5,000,000 | ||
Less: unamortized debt discount and OID accretion | $ (500,000) | ||
Financing costs | (20,000) | ||
Debt issuance costs | 37,000 | ||
Debt discount and derivative liability at the issuance date | $ 1,300,000 | ||
Amortization of debt discount | $ 100,000 | ||
Debt interest rate | 10.00% | ||
Interest rate upon default | 18.00% | ||
Stock price trigger (in usd per share) | $ / shares | $ 10 | ||
Percentage of the VWAP | 80.00% | ||
Threshold trading days | day | 20 | ||
Debt instrument, cap rate | 19.99% | ||
Unsecured Convertible Promissory Note | Debt Instrument, Redemption, Period One | |||
Short-term Debt [Line Items] | |||
Debt instrument, redemption period | 15 months | ||
Redemption price | $ 500,000 | ||
Unsecured Convertible Promissory Note | Debt Instrument, Redemption, Period Two | |||
Short-term Debt [Line Items] | |||
Debt instrument, redemption period | 6 months | ||
Redemption price | $ 750,000 | ||
Unsecured Convertible Promissory Note | Minimum | |||
Short-term Debt [Line Items] | |||
Event of default rate of increase in outstanding obligations | 5.00% | ||
Unsecured Convertible Promissory Note | Maximum | |||
Short-term Debt [Line Items] | |||
Event of default rate of increase in outstanding obligations | 15.00% |
DEBT - Schedule of Convertible
DEBT - Schedule of Convertible Note (Details) - Unsecured Convertible Promissory Note | Mar. 31, 2019USD ($) |
Short-term Debt [Line Items] | |
Convertible Note | $ 5,500,000 |
Less: unamortized debt discount and OID accretion | (1,763,197) |
Total | $ 3,736,803 |
LICENSE AGREEMENTS (Details)
LICENSE AGREEMENTS (Details) - USD ($) $ in Millions | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2019 | Dec. 31, 2016 | Dec. 31, 2014 | Dec. 31, 2013 | |
Assets Sold under Agreements to Repurchase [Line Items] | ||||
Milestone fee free sales target value | $ 1,500 | |||
Royalty payment expiration requirement | 10 years | |||
Minimum | ||||
Assets Sold under Agreements to Repurchase [Line Items] | ||||
Royalty payment percentage | 5.00% | |||
Maximum | ||||
Assets Sold under Agreements to Repurchase [Line Items] | ||||
Royalty payment percentage | 15.00% | |||
Alba Agreement | ||||
Assets Sold under Agreements to Repurchase [Line Items] | ||||
License fees | 0.5 | |||
Milestone payment | 1.5 | |||
Sales range minimum | 100 | |||
Sales range maximum | 1,500 | |||
Seachaid Agreement | ||||
Assets Sold under Agreements to Repurchase [Line Items] | ||||
License fees | $ 0.2 | |||
Milestone payment | 6 | |||
Sales range minimum | 1 | |||
Sales range maximum | $ 2.5 | |||
License and Service | Alba Agreement | ||||
Assets Sold under Agreements to Repurchase [Line Items] | ||||
License and services revenue | 150 | |||
License | Alba Agreement | ||||
Assets Sold under Agreements to Repurchase [Line Items] | ||||
License costs | $ 2.5 |
STOCKHOLDERS_ EQUITY (Details)
STOCKHOLDERS’ EQUITY (Details) - USD ($) $ / shares in Units, $ in Thousands | Mar. 18, 2019 | Jul. 13, 2018 | Mar. 31, 2019 | Dec. 31, 2018 | Mar. 31, 2018 | Dec. 31, 2017 |
Class of Stock [Line Items] | ||||||
Capital stock authorized (in shares) | 360,000,000 | |||||
Common stock, par or stated value per share (in usd per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.001 | ||
Common stock, shares authorized (in shares) | 350,000,000 | 350,000,000 | ||||
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 | ||||
Number of shares issued in transaction (in shares) | 4,181,068 | |||||
Number of securities called by each warrant (in shares) | 6,689,702 | |||||
At-the-Market Offering | ||||||
Class of Stock [Line Items] | ||||||
Number of shares issued in transaction (in shares) | 705,714 | |||||
Sale of stock, ATM maximum equity offering price | $ 40,000 | |||||
Sale of stock, agent commissions fee | 3.00% | |||||
Consideration received on transaction | $ 1,675 |
STOCKHOLDERS' EQUITY - Reserve
STOCKHOLDERS' EQUITY - Reserve Shares of Common Stock (Details) - shares | Mar. 31, 2019 | Dec. 31, 2018 |
Class of Stock [Line Items] | ||
Capital shares reserved for future issuance (in shares) | 20,868,638 | 12,981,599 |
Stock Options Outstanding | ||
Class of Stock [Line Items] | ||
Capital shares reserved for future issuance (in shares) | 7,182,002 | 7,117,002 |
Warrants to Purchase Common Stock | ||
Class of Stock [Line Items] | ||
Capital shares reserved for future issuance (in shares) | 8,604,018 | 1,914,316 |
Conversion Debt | ||
Class of Stock [Line Items] | ||
Capital shares reserved for future issuance (in shares) | 1,703,119.69230769 | 1,720,224 |
Omnibus Incentive Plan 2012 | ||
Class of Stock [Line Items] | ||
Capital shares reserved for future issuance (in shares) | 3,379,498 | 2,230,057 |
SHARE-BASED COMPENSATION - Narr
SHARE-BASED COMPENSATION - Narrative (Details) | Jan. 01, 2019shares | Mar. 31, 2019USD ($)plan$ / sharesshares | Mar. 31, 2018USD ($)shares | Dec. 31, 2018shares |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of stock option plans | plan | 2 | |||
Allocated share-based compensation expense | $ 526,000 | $ 7,174,000 | ||
Omnibus Incentive Plan 2012 | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of additional shares authorized (in shares) | shares | 1,304,441 | 3,000,000 | ||
Purchase price of common stock, percent | 5.00% | |||
Options available for future grants (in shares) | shares | 3,379,498 | |||
Weighted-average grant date fair value of options granted (in usd per share) | $ / shares | $ 1.29 | |||
Options granted (in shares) | shares | 65,000 | 0 | ||
Fair value of stock option awards vested | $ 118,000 | |||
Unrecognized compensation cost | $ 900,000 | |||
Weighted-average period for recognizing cost | 2 years 9 months 18 days | |||
Expected term | 10 years | |||
Private Innovate 2015 Stock Incentive Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options granted (in shares) | shares | 0 | 0 | ||
Fair value of stock option awards vested | $ 145,000 | |||
Unrecognized compensation cost | $ 900,000 | |||
Weighted-average period for recognizing cost | 2 years | |||
Minimum | Omnibus Incentive Plan 2012 | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Award vesting period | 3 years | |||
Maximum | Omnibus Incentive Plan 2012 | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Award vesting period | 4 years | |||
Restricted Stock Units (RSUs) | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Weighted-average grant date fair value of options granted (in usd per share) | $ / shares | $ 2.12 | |||
Number of shares granted (in shares) | shares | 90,000 | 0 | ||
Allocated share-based compensation expense | $ 190,000 |
SHARE-BASED COMPENSATION - (Det
SHARE-BASED COMPENSATION - (Details) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Private Innovate 2015 Stock Incentive Plan | ||
Expected dividend yield | 0.00% | 0.00% |
Expected stock price volatility | 67.00% | |
Risk-free interest rate | 2.60% | |
Private Innovate 2015 Stock Incentive Plan | Minimum | ||
Expected stock price volatility | 68.00% | |
Risk-free interest rate | 2.70% | |
Term of options | 8 years 2 months 12 days | 9 years |
Private Innovate 2015 Stock Incentive Plan | Maximum | ||
Expected stock price volatility | 72.00% | |
Risk-free interest rate | 2.90% | |
Term of options | 8 years 8 months 12 days | 9 years 6 months |
Omnibus Incentive Plan 2012 | ||
Expected dividend yield | 0.00% | |
Omnibus Incentive Plan 2012 | Minimum | ||
Expected stock price volatility | 68.00% | |
Risk-free interest rate | 2.50% | |
Term of options | 5 years 4 months 24 days | |
Omnibus Incentive Plan 2012 | Maximum | ||
Expected stock price volatility | 72.00% | |
Risk-free interest rate | 2.70% | |
Term of options | 10 years |
SHARE-BASED COMPENSATION - Stoc
SHARE-BASED COMPENSATION - Stock Option Activity (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | |
Private Innovate 2015 Stock Incentive Plan | |||
Number of Shares | |||
Beginning balance (in shares) | 6,340,871 | ||
Options granted (in shares) | 0 | 0 | |
Options forfeited (in shares) | 0 | ||
Options exercised (in shares) | 0 | ||
Ending balance (in shares) | 6,340,871 | 6,340,871 | |
Exercisable (in shares) | 5,664,831 | ||
Vested and expected to vest (in shares) | 6,309,322 | ||
Weighted-Average Exercise Price | |||
Beginning balance (in usd per share) | $ 1.53 | ||
Options granted (in usd per share) | 0 | ||
Options forfeited (in usd per share) | 0 | ||
Options exercised (in usd per share) | 0 | ||
Ending balance (in usd per share) | 1.53 | $ 1.53 | |
Exercisable (in usd per share) | 1.45 | ||
Vested and expected to vest (in usd per share) | $ 1.52 | ||
Aggregate Intrinsic Value | |||
Outstanding | $ 3,315,876 | $ 6,617,433 | |
Exercisable | 3,315,876 | ||
Vested and expected to vest | $ 3,315,876 | ||
Weighted-Average Remaining Contractual Life (in years) | |||
Outstanding (in years) | 6 years 2 months 12 days | 7 years 8 months 12 days | |
Exercisable (in years) | 5 years 10 months 24 days | ||
Vested and expected to vest (in years) | 6 years 2 months 12 days | ||
Omnibus Incentive Plan 2012 | |||
Number of Shares | |||
Beginning balance (in shares) | 776,131 | ||
Options granted (in shares) | 65,000 | 0 | |
Options forfeited (in shares) | 0 | ||
Options exercised (in shares) | 0 | ||
Ending balance (in shares) | 841,131 | 776,131 | |
Exercisable (in shares) | 390,282 | ||
Vested and expected to vest (in shares) | 809,079 | ||
Weighted-Average Exercise Price | |||
Beginning balance (in usd per share) | $ 5.79 | ||
Options granted (in usd per share) | 2.04 | ||
Options forfeited (in usd per share) | 0 | ||
Options exercised (in usd per share) | 0 | ||
Ending balance (in usd per share) | 5.50 | $ 5.79 | |
Exercisable (in usd per share) | 6.01 | ||
Vested and expected to vest (in usd per share) | $ 5.51 | ||
Aggregate Intrinsic Value | |||
Outstanding | $ 0 | $ 0 | |
Exercisable | 0 | ||
Vested and expected to vest | $ 0 | ||
Weighted-Average Remaining Contractual Life (in years) | |||
Outstanding (in years) | 7 years 4 months 24 days | 7 years 4 months 24 days | |
Exercisable (in years) | 4 years 10 months 24 days | ||
Vested and expected to vest (in years) | 7 years 3 months 18 days |
SHARED-BASED COMPENSATION - Fin
SHARED-BASED COMPENSATION - Financial Statements (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Allocated share-based compensation expense | $ 526,000 | $ 7,174,000 |
Research and Development Expense | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Allocated share-based compensation expense | 92,000 | 5,751,000 |
General and Administrative Expense | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Allocated share-based compensation expense | $ 434,000 | $ 1,423,000 |
COMMITMENTS AND CONTINGENCIES -
COMMITMENTS AND CONTINGENCIES - Narrative (Details) | Mar. 11, 2018 | Nov. 30, 2018USD ($) | Oct. 31, 2018USD ($) | Aug. 31, 2018USD ($) | Oct. 31, 2017USD ($) | Mar. 31, 2019USD ($)executive | Mar. 31, 2018USD ($) | Dec. 31, 2018USD ($) | Jan. 01, 2019 |
Loss Contingencies [Line Items] | |||||||||
Payment for management fee | $ 1,100,000 | ||||||||
Payments to executives | $ 1,100,000 | ||||||||
Severance provisions, annual base salary | 12 months | ||||||||
Severance provisions, continuation of health insurance benefits | 12 months | ||||||||
Severance costs, equal installments | 12 months | ||||||||
Number of former executives | executive | 2 | ||||||||
Deferred compensation, liability, current | $ 500,000 | ||||||||
Term of contract | 3 years | ||||||||
Operating lease annual rental payments | $ 60,000 | ||||||||
Operating lease monthly rental payments | $ 5,000 | ||||||||
Operating lease, weighted average remaining lease term | 24 months | ||||||||
Security deposit | $ 5,000 | ||||||||
Renewal term | 2 years | 2 years | |||||||
Operating lease, cost | $ 15,000 | ||||||||
Operating lease, expense | $ 15,000 | ||||||||
Increase (decrease) in operating lease liabilities | 100,000 | ||||||||
Loss contingency, damages sought, value | $ 3,600,000 | ||||||||
Executive Severance | |||||||||
Loss Contingencies [Line Items] | |||||||||
Severance costs | $ 300,000 | ||||||||
Accounting Standards Update 2016-02 | |||||||||
Loss Contingencies [Line Items] | |||||||||
Operating lease, weighted average discount rate, percent | 12.00% |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES - Future Minimum Payments for Operating Lease Liabilities (Details) | Mar. 31, 2019USD ($) |
Leases, Operating [Abstract] | |
2019 | $ 45,000 |
2020 | 45,000 |
Total lease payment | 90,000 |
Less: imputed interest | (8,008) |
Total | $ 81,992 |
SUBSEQUENT EVENTS - Additional
SUBSEQUENT EVENTS - Additional Issuance of Warrants (Details) - $ / shares | Apr. 29, 2019 | Apr. 25, 2019 | Mar. 18, 2019 | Jan. 29, 2019 |
Subsequent Event [Line Items] | ||||
Shares issued, price per share (in usd per share) | $ 2.33 | |||
Number of securities called by each warrant (in shares) | 6,689,702 | |||
Warrant term | 5 years | |||
Number of shares issued in transaction (in shares) | 4,181,068 | |||
Subsequent Event | ||||
Subsequent Event [Line Items] | ||||
Restriction period | 45 days | |||
Purchase price of each additional warrant | $ 0.125 | |||
Shares issued, price per share (in usd per share) | $ 2.025 | |||
Exercise price of warrants or rights (in usd per share) | $ 2.13 | |||
Number of securities called by each warrant (in shares) | 3,900,000 | |||
Warrant term | 5 years | |||
Exercise commencement period | 5 years 6 months | 6 months | ||
Number of shares issued in transaction (in shares) | 4,318,272 |
SUBSEQUENT EVENTS - April 2019
SUBSEQUENT EVENTS - April 2019 Offering (Details) - USD ($) | Apr. 29, 2019 | Apr. 25, 2019 | Mar. 18, 2019 | Jan. 29, 2019 | Mar. 31, 2019 | Dec. 31, 2018 |
Subsequent Event [Line Items] | ||||||
Number of shares issued in transaction (in shares) | 4,181,068 | |||||
Shares issued, price per share (in usd per share) | $ 2.33 | |||||
Proceeds from issuance of common stock | $ 9,700,000 | |||||
Warrant term | 5 years | |||||
Placement agent fees | $ 1,600,000 | |||||
Legal fees | $ 100,056 | $ 104,706 | ||||
Subsequent Event | ||||||
Subsequent Event [Line Items] | ||||||
Number of shares issued in transaction (in shares) | 4,318,272 | |||||
Shares issued, price per share (in usd per share) | $ 2.025 | |||||
Exercise commencement period | 5 years 6 months | 6 months | ||||
Exercise price of warrants or rights (in usd per share) | $ 2.13 | |||||
Proceeds from issuance of common stock | $ 7,900,000 | |||||
Warrant term | 5 years | |||||
Warrant | ||||||
Subsequent Event [Line Items] | ||||||
Exercise price of warrants or rights (in usd per share) | $ 3.18 | |||||
Warrant | Subsequent Event | ||||||
Subsequent Event [Line Items] | ||||||
Number of securities called by warrants or rights (in shares) | 4,318,272 | |||||
Exercise price of warrants or rights (in usd per share) | $ 2.13 | |||||
Ownership percentage of common shares outstanding | 4.99% | |||||
Ownership percentage of common shares outstanding, at election of holder | 9.99% | |||||
Effective period | 61 days | |||||
Placement Agent Warrants | Subsequent Event | ||||||
Subsequent Event [Line Items] | ||||||
Number of securities called by warrants or rights (in shares) | 215,914 | |||||
Exercise price of warrants or rights (in usd per share) | $ 2.6625 | |||||
Warrant term | 5 years | |||||
Placement agent fees | $ 35,000 | |||||
Legal fees | $ 25,000 |