Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2016 | May. 10, 2016 | |
Document Information [Line Items] | ||
Entity Registrant Name | Enumeral Biomedical Holdings, Inc. | |
Entity Central Index Key | 1,561,551 | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2016 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Smaller Reporting Company | |
Entity Common Stock, Shares Outstanding | 52,073,481 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q1 | |
Entity Voluntary Filers | No | |
Entity Well-known Seasoned Issuer | No |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) | Mar. 31, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 1,837,304 | $ 3,596,262 |
Accounts receivable | 390,944 | 306,012 |
Prepaid expenses and other current assets | 180,411 | 280,479 |
Total current assets | 2,408,659 | 4,182,753 |
Property and equipment, net | 1,325,638 | 1,511,493 |
Other assets: | ||
Restricted cash | 534,780 | 534,780 |
Other assets | 111,556 | 114,572 |
Total assets | 4,380,633 | 6,343,598 |
Current liabilities: | ||
Accounts payable | 440,113 | 343,736 |
Accrued expenses | 648,072 | 714,384 |
Deferred revenue | 87,026 | 130,539 |
Equipment lease financing | 243,215 | 240,473 |
Derivative liabilities | 1,459,656 | 2,138,091 |
Total current liabilities | 2,878,082 | 3,567,223 |
Deferred rent | 46,106 | 36,847 |
Long-term equipment lease financing | 204,629 | 266,471 |
Total liabilities | $ 3,128,817 | $ 3,870,541 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred stock, $.001 par value; 10,000,000 shares authorized: -0- shares issued and outstanding as of March 31, 2016 and December 31, 2015, respectively | ||
Common stock, $.001 par value; 300,000,000 shares authorized: 52,073,481 and 51,932,571 shares issued and outstanding as of March 31, 2016 and December 31, 2015, respectively | $ 52,074 | $ 51,933 |
Additional paid-in-capital | 17,163,770 | 16,830,100 |
Accumulated deficit | (15,964,028) | (14,408,976) |
Total stockholders' equity | 1,251,816 | 2,473,057 |
Total liabilities and stockholders' equity | $ 4,380,633 | $ 6,343,598 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2016 | Dec. 31, 2015 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 300,000,000 | 300,000,000 |
Common stock, shares issued | 51,932,571 | 51,932,571 |
Common stock, shares outstanding | 51,932,571 | 51,932,571 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) (Unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Revenue: | ||
Collaboration and license revenue | $ 316,018 | $ 209,635 |
Grant revenue | 118,439 | 65,087 |
Total revenue | 434,457 | 274,722 |
Cost of revenue and expenses: | ||
Research and development | 1,470,043 | 1,230,504 |
General and administrative | 1,194,334 | 1,424,943 |
Total cost of revenue and expenses | 2,664,377 | 2,655,447 |
Loss from operations | (2,229,920) | (2,380,725) |
Other income (expense): | ||
Interest income (expense) | (3,567) | 2,635 |
Change in fair value of derivative liabilities | 678,435 | 4,669,884 |
Total other income (expense), net | 674,868 | 4,672,519 |
Net income (loss) before income taxes | $ (1,555,052) | $ 2,291,794 |
Provision for income taxes | ||
Net Income (Loss) | $ (1,555,052) | $ 2,291,794 |
Other comprehensive income (loss): | ||
Reclassification for loss included in net income | 6 | |
Net unrealized holding losses on available-for-sale securities arising during the period | (6,590) | |
Comprehensive income (loss) | $ (1,555,052) | $ 2,285,210 |
Basic net income (loss) per share | $ (0.03) | $ 0.04 |
Diluted net income (loss) per share | $ (0.03) | $ 0.04 |
Weighted-average number of common shares attributable to common stockholders - basic | 52,068,784 | 51,607,454 |
Weighted-average number of common shares attributable to common stockholders - diluted | 52,068,784 | 52,849,869 |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Cash flows from operating activities: | ||
Net income (loss) | $ (1,555,052) | $ 2,291,794 |
Adjustments to reconcile net income (loss) to net cash used in operating activities: | ||
Depreciation and Amortization | $ 185,855 | 136,298 |
Exit costs associated with write-down of net carrying value of leasehold improvements | 22,962 | |
Stock-based compensation | $ 333,811 | 166,391 |
Change in fair value of derivative liabilities | (678,435) | (4,669,884) |
Changes in operating assets and liabilities: | ||
Accounts receivable | (84,932) | 53,192 |
Prepaid expenses and other assets | 103,084 | (44,928) |
Accounts payable | 96,377 | (349,620) |
Accrued expenses | (66,312) | 333,289 |
Deferred rent | 9,259 | (28,732) |
Deferred revenue | (43,513) | 24,990 |
Net cash used in operating activities | $ (1,699,858) | (2,064,248) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (391,930) | |
Proceeds from sales of marketable securities | 1,000,805 | |
Net cash provided by investing activities | $ 608,875 | |
Cash flows from financing activities: | ||
Payments on equipment lease financing | $ (59,100) | |
Net cash used in financing activities | (59,100) | |
Net decrease in cash and cash equivalents | (1,758,958) | $ (1,455,373) |
Cash and cash equivalents, beginning of period | 3,596,262 | 10,460,117 |
Cash and cash equivalents, end of period | 1,837,304 | $ 9,004,744 |
Supplemental cash flow disclosure of financing activities: | ||
Cash paid for interest | $ 5,536 |
NATURE OF BUSINESS
NATURE OF BUSINESS | 3 Months Ended |
Mar. 31, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
NATURE OF BUSINESS | 1 - NATURE OF BUSINESS Enumeral Biomedical Corp. (Enumeral) was founded in 2009 in the state of Delaware as Enumeral Technologies, Inc. The name was later changed to Enumeral Biomedical Corp. On July 31, 2014 (the Closing Date), Enumeral entered into an Agreement and Plan of Merger and Reorganization (the Merger Agreement) with Enumeral Biomedical Holdings, Inc., which was formerly known as Cerulean Group, Inc. (Enumeral Biomedical or the Company), and Enumeral Acquisition Corp., a wholly owned subsidiary of Enumeral Biomedical (Acquisition Sub), pursuant to which the Acquisition Sub merged with and into Enumeral (the Merger). Enumeral was the surviving corporation in the Merger and became a wholly owned subsidiary of the Company. As a result of the Merger, all issued and outstanding common and preferred shares of Enumeral were exchanged for common shares of Enumeral Biomedical Holdings, Inc. The Merger is considered to be a recapitalization of the Company which has been retrospectively applied to these unaudited condensed consolidated financial statements for all periods presented. Upon the closing of the Merger and under the terms of a split-off agreement and a general release agreement (the Split-Off Agreement), the Company transferred all of its pre-Merger operating assets and liabilities to its wholly-owned special-purpose subsidiary, Cerulean Operating Corp. (the Split-Off Subsidiary). Thereafter, pursuant to the Split-Off Agreement, the Company transferred all of the outstanding shares of capital stock of Split-Off Subsidiary to the pre-Merger majority stockholder of the Company, and the former sole officer and director of the Company (the Split-Off), in consideration of and in exchange for (i) the surrender and cancellation of an aggregate of 23,100,000 shares of the Companys common stock held by such stockholder (which were cancelled and will resume the status of authorized but unissued shares of the Companys common stock) and (ii) certain representations, covenants and indemnities. As a result of the Merger and Split-Off, the Company discontinued its pre-Merger business, acquired the business of Enumeral, and changed its name to Enumeral Biomedical Holdings, Inc. Also on July 31, 2014, the Company closed a private placement offering (the PPO) of 21,549,510 Units (the Units) of its securities, at a purchase price of $1.00 per Unit, each Unit consisting of one share of the Companys common stock and a warrant to purchase one share of the Companys common stock at an exercise price of $2.00 per share with a term of five years (the PPO Warrants). Additional information concerning the PPO and PPO Warrants is presented below in Note 10. Following the Merger, the Company has continued Enumerals business of discovering and developing novel antibody immunotherapies that help the immune system fight cancer and other diseases. The Company utilizes a proprietary platform technology that facilitates the rapid high resolution measurement of immune cell function within small tissue biopsy samples. The Companys initial focus is on the development of a pipeline of next generation monoclonal antibody drugs targeting established and novel immunomodulatory receptors. In its lead antibody program, the Company has characterized certain anti-PD-1 antibodies, or simply PD-1 antibodies, using patient biopsy samples, in an effort to identify next generation PD-1 antagonists with enhanced selectivity for the immune effector cells that carry out anti-tumor functions. The Company has identified two antagonist PD-1 antibodies that inhibit PD-1 activity in distinctly different ways. One of the antibodies blocks binding of the ligand PD-L1 to PD-1, while the other antibody does not. However, both display activity in various biological assays. In addition to its PD-1 antibody program, the Company is developing antibody drug candidates targeting TIM-3, LAG-3, OX40, TIGIT and VISTA. The Company is also pursuing several antibody programs for which it has not yet publicly disclosed the targets. The Companys proprietary platform technology, exclusively licensed from the Massachusetts Institute of Technology (MIT), is a microwell array technology that detects secreted molecules (such as antibodies and cytokines) and cell surface markers, at the level of single live cells and enables recovery of single live cells of interest. The platform technology is a multipurpose tool that is valuable for activities ranging from antibody discovery to target discovery and patient stratification in clinical development. The platform yields multidimensional, functional read-outs from single live cells, such as tumor infiltrating lymphocytes, or TILs, from human tumor biopsy samples, and it enables the Companys researchers to examine the responses of different classes of human immune cells to treatment with immunomodulators in the context of human disease, as opposed to animal models of disease. The Company continues to be a smaller reporting company, as defined under the Exchange Act, following the Merger. The Company believes that as a result of the Merger, it has ceased to be a shell company (as such term is defined in Rule 12b-2 under the Securities and Exchange Act of 1934, as amended (the Exchange Act)). |
GOING CONCERN AND LIQUIDITY
GOING CONCERN AND LIQUIDITY | 3 Months Ended |
Mar. 31, 2016 | |
Risks and Uncertainties [Abstract] | |
GOING CONCERN AND LIQUIDITY | 2 - GOING CONCERN AND LIQUIDITY The Companys unaudited condensed consolidated financial statements have been prepared in conformity with generally accepted accounting principles in the United States which contemplate the Companys continuation as a going concern. As of March 31, 2016, the Company had a working capital deficit of $469,423 including $1,459,656 of derivative liabilities and an accumulated deficit of $15,964,028. As of December 31, 2015, the Company had working capital of $615,530 including $2,138,091 of derivative liabilities and an accumulated deficit of $14,408,976. As of the date of this filing, the Company believes it only has sufficient liquidity to fund operations through June 2016. The Companys June 2016 liquidity projections do not include any additional funding that the Company may receive in the future from collaboration arrangements, including the license and transfer agreement with Pieris Pharmaceuticals described further in Note 3 below. Even if the Company receives the additional $750,000 maintenance fee from Pieris Pharmaceuticals described in Note 3, the Company will still require additional capital to continue its operations through the third quarter of 2016. The Company is currently exploring a range of potential transactions, which may include public or private equity offerings, debt financings, collaborations and licensing arrangements, and/or other strategic alternatives, including a merger, sale of assets or other similar transactions. If the Company is unable to raise additional capital on terms acceptable to the Company and on a timely basis, the Company may be required to downsize or wind down its operations through liquidation, bankruptcy, or a sale of its assets. The unaudited condensed consolidated financial statements do not include any adjustments related to the recovery and classification of asset carrying amounts or the amount and classification of liabilities that might result should the Company be unable to continue as a going concern. The Company expects to incur significant expenses and operating losses for the foreseeable future, and the Companys net losses may fluctuate significantly from quarter to quarter and from year to year. These factors raise substantial doubt about the Companys ability to continue as a going concern. The Companys business has not generated (nor does the Company anticipate that in the foreseeable future it will generate) the cash necessary to finance its operations, and the Company will require additional capital to continue its operations beyond June 2016. The Companys near-term capital needs depend on many factors, including: · the Companys ability to carefully manage its costs; · the amount and timing of revenue received from grants or the Companys collaboration and license arrangements; and · the Companys ability to raise additional capital through public or private equity offerings, debt financings, or strategic collaborations and licensing arrangements, and/or the Companys success in promptly establishing a strategic alternative that is in its stockholders best interests. If the Company is unable to preserve or raise additional capital through one or more of the means listed above prior to the end of June 2016, the Company could face substantial liquidity problems and might be required to implement cost reduction strategies in addition to the cash conservation steps that the Company has already taken. These reductions could significantly affect the Companys research and development activities, and could result in significant harm to the Companys business, financial condition and results of operations. In addition, these reductions could cause the Company to further curtail its operations, or take other actions that would adversely affect the Companys stockholders. If the Company is unable to raise additional capital on acceptable terms and on a timely basis, the Company may be required to downsize or wind down its operations through liquidation, bankruptcy, or a sale of its assets. In addition, to the extent additional capital is raised through the sale of equity or convertible debt securities, such securities may be sold at a discount from the market price of the Companys common stock. The issuance of these securities could also result in significant dilution to some or all of the Companys stockholders, depending on the terms of the transaction. For example, the shares included in the Units and the warrants issued in connection with the PPO contain anti-dilution protection in the event that within certain specified time periods the Company issues common stock or securities convertible into or exercisable for shares of the Companys common stock at a price lower than the Unit purchase price or the warrant exercise price, as applicable. The anti-dilution protection provisions apply to issuances within two years after the closing of the PPO in the case of the Units and, with respect to the warrants, prior to the warrant expiration date. In addition, the anti-dilution protection provisions are subject to exceptions for certain issuances, including but not limited to (a) shares of common stock issued in an underwritten public offering, (b) issuances of awards under the Companys 2014 Equity Incentive Plan, and (c) other exempt issuances. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 3 Months Ended |
Mar. 31, 2016 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 3 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The accompanying unaudited condensed consolidated financial statements were prepared using generally accepted accounting principles for interim financial information and the instructions to Form 10-Q and Regulation S-X. Accordingly, these unaudited condensed consolidated financial statements do not include all information or notes required by generally accepted accounting principles for annual financial statements and should be read in conjunction with the 2015 Financial Statements as filed on the Company's Annual Report on Form 10-K for the year ended December 31, 2015, which was filed with the SEC on March 30, 2016. The preparation of the unaudited condensed consolidated financial statements in conformity with these accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the unaudited condensed consolidated financial statements and the reported amounts of expenses during the reported period. Ultimate results could differ from the estimates of management. In the opinion of management, the unaudited condensed consolidated financial statements included herein contain all adjustments necessary to present fairly the Company's financial position as of March 31, 2016 and the results of its operations and cash flows for the three months ended March 31, 2016 and 2015. Such adjustments are of a normal recurring nature. The results of operations for the three months ended March 31, 2016 may not be indicative of results for the full year. Principles of Consolidation The unaudited condensed consolidated financial statements include the accounts of the Company and its subsidiaries, Enumeral Biomedical Corp. and Enumeral Securities Corporation. In these unaudited condensed consolidated financial statements, subsidiaries are companies that are wholly owned, the accounts of which are consolidated with those of the Company. Intercompany transactions and balances are eliminated in consolidation. Cash and Cash Equivalents The Company considers all highly liquid investments with maturities of 90 days or less from the purchase date to be cash equivalents. Cash and cash equivalents are held in depository and money market accounts and are reported at fair value. Concentration of Credit Risk The Company has no significant off-balance sheet concentrations of credit risk such as foreign currency exchange contracts, option contracts or other hedging arrangements. Financial instruments that subject the Company to credit risk consist primarily of cash and cash equivalents. The Company generally invests its cash in money market funds, U.S. Treasury securities and U.S. Agency securities that are subject to minimal credit and market risk. Management has established guidelines relative to credit ratings and maturities intended to safeguard principal balances and maintain liquidity. At times, the Companys cash balances may exceed the current insured amounts under the Federal Deposit Insurance Corporation. Fair Value of Financial Instruments Fair values of financial instruments included in current assets and current liabilities are estimated to approximate their book values, due to the short maturity of such instruments. All debt is based on current rates at which the Company could borrow funds with similar remaining maturities and approximates fair value. The Companys assets and liabilities that are measured at fair value on a recurring basis are measured in accordance with the Financial Accounting Standards Boards (FASB) Accounting Standards Codification (ASC) Topic 820, Fair Value Measurements and Disclosures The valuation hierarchy is based upon the transparency of inputs to the valuation of an asset or liability as of the measurement date. The three levels are defined as follows: Level 1 Level 2 Level 3 The Companys cash equivalents, carried at fair value, are comprised of investments in federal agency backed money market funds. The valuation of the Companys derivative liabilities is discussed below and in Note 11. The following table presents information about the Companys financial assets and liabilities measured at fair value on a recurring basis as of March 31, 2016 and December 31, 2015: March 31, 2016 Quoted Prices in Active Markets (Level 1) Observable Inputs (Level 2) Unobservable Inputs (Level 3) Assets Cash $ 755,354 $ 755,354 $ - $ - Money Market funds, included in cash equivalents $ 1,081,950 $ 1,081,950 $ - $ - Liabilities Derivative liabilities $ 1,459,656 $ - $ - $ 1,459,656 December 31, 2015 Quoted Prices in Active Markets (Level 1) Observable Inputs (Level 2) Unobservable Inputs (Level 3) Assets Cash $ 815,890 $ 815,890 $ - $ - Money Market funds, included in cash equivalents $ 2,780,372 $ 2,780,372 $ - $ - Liabilities Derivative liabilities $ 2,138,091 $ - $ - $ 2,138,091 The following table provides a roll forward of the fair value of the Companys derivative liabilities, using Level 3 inputs: Balance as of December 31, 2015 $ 2,138,091 Change in fair value (678,435) Balance as of March 31, 2016 $ 1,459,656 Accounts Receivable and Allowance for Doubtful Accounts Trade receivables are recorded at the invoiced amount. The Company maintains allowances for doubtful accounts, if needed, for estimated losses resulting from the inability of customers to make required payments. This allowance is based on specific customer account reviews and historical collections experience. There was no allowance for doubtful accounts as of March 31, 2016 or December 31, 2015. Property and Equipment Property and equipment are recorded at cost. Expenditures for maintenance and repairs are charged to expense as incurred, whereas major betterments are capitalized as additions to property and equipment. Depreciation is provided using the straight-line method over the estimated useful lives of the assets as follows: Lab equipment 3-5 years Computer equipment and software 3 years Furniture 3 years Leasehold improvements Shorter of useful life or life of the lease Impairment of Long-Lived Assets Long-lived assets are reviewed for impairment annually or whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. When such events occur, the Company compares the carrying amounts of the assets to their undiscounted expected future cash flows. If this comparison indicated that there is impairment, the amount of the impairment is calculated as the difference between the carrying value and fair value. There have been no impairments recognized during the three months ended March 31, 2016 and 2015, respectively. Revenue Recognition Collaboration and license revenue Non-refundable license fees are recognized as revenue when the Company has a contractual right to receive such payment, the contract price is fixed or determinable, the collection of the resulting receivable is reasonably assured and the Company has no further performance obligations under the license agreement. Multiple element arrangements, such as license and development arrangements are analyzed to determine whether the deliverables, which often include license and performance obligations such as research and steering committee services, can be separated or whether they must be accounted for as a single unit of accounting in accordance with GAAP. The Company recognizes up-front license payments as revenue upon delivery of the license only if the license has stand-alone value and the fair value of the undelivered performance obligations, typically including research and/or steering committee services, can be determined. If the fair value of the undelivered performance obligations can be determined, such obligations would then be accounted for separately as performed. If the license is considered to either (i) not have stand-alone or (ii) have stand-alone value but the fair value of any of the undelivered performance obligations cannot be determined, the arrangement would then be accounted for as a single unit of accounting and the license payments and payments for performance obligations are recognized as revenue over the estimated period of when the performance obligations are performed. Whenever the Company determines that an arrangement should be accounted for as a single unit of accounting, it must determine the period over which the performance obligations will be performed and revenue will be recognized. Revenue will be recognized using either a relative performance or straight-line method. The Company recognizes revenue using the relative performance method provided that it can reasonably estimate the level of effort required to complete its performance obligations under an arrangement and such performance obligations are provided on a best-efforts basis. Direct labor hours or full-time equivalents are typically used as a measure of performance. Revenue recognized under the relative performance method would be determined by multiplying the total payments under the contract, excluding royalties and payments contingent upon achievement of substantive milestones, by the ratio of level of effort incurred to date to estimated total level of effort required to complete the Companys performance obligations under the arrangement. Revenue is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using the relative performance method, as of each reporting period. If the Company cannot reasonably estimate the level of effort required to complete its performance obligations under an arrangement, the performance obligations are provided on best-efforts basis and the Company can reasonably estimate when the performance obligation ceases or the remaining obligations become inconsequential and perfunctory. At that time, the total payments under the arrangement, excluding royalties and payments contingent upon achievement of substantive milestones, would be recognized as revenue on a straight-line basis over a period the Company expects to complete its performance obligations. Revenue is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using the straight-line basis, as of the period ending date. In December 2014, the Company entered into a study agreement with Merck Sharp & Dohme Corp., or Merck (the Merck Agreement). In February 2016, the Company and Merck subsequently amended the work plan under the Merck Agreement to also include non-small cell lung cancer tissues. Pursuant to the Merck Agreement, the Company is conducting a specified research program using its platform technology to identify functional response of single cell types in colorectal cancer and non-small cell lung cancer in the presence or absence of immunomodulatory receptor modulators identified by Merck. In this collaboration, Merck is reimbursing the Company for the cost of performing the work plan set forth in the Merck Agreement, for up to a specified number of full-time employees at a pre-determined annual rate. In addition, Merck will make certain milestone payments to the Company upon the completion of specified objectives set forth in the Merck Agreement and related work plan. In September 2015, the Company announced the achievement of the first milestone under the Merck Agreement. In January 2016, the Company and The University of Texas M.D. Anderson Cancer Center (MDACC) entered into a Collaborative Research and Development Agreement (the MDACC Agreement). Under the MDACC Agreement, the Company and MDACC plan to collaborate on the discovery and development of novel monoclonal antibodies against selected targets in immune-oncology, utilizing the Companys antibody discovery and immune profiling platform and MDACCs preclinical and development expertise and infrastructure. Pursuant to the terms of the MDACC Agreement, the Company and MDACC will share the costs of research and development activities necessary to take development candidates through successful completion of a Phase I clinical trial. The MDACC Agreement provides for a structure whereby the Company and MDACC are each granted the right to receive a percentage of the net income from product sales or any payments associated with licensing or otherwise partnering a program with a third party. In April 2016, the Company entered into a License and Transfer Agreement (the License Agreement) with Pieris Pharmaceuticals, Inc. and Pieris Pharmaceuticals GmbH (collectively, Pieris). Pursuant to the terms and conditions of the License Agreement, Pieris is licensing from the Company specified intellectual property related to the Companys anti-PD-1 antibody program ENUM 388D4 for the potential development and commercialization by Pieris of novel multispecific therapeutic proteins comprising fusion proteins based on Pieris Anticalins ® Under the License Agreement, Pieris paid the Company a $250,000 initial license fee. The License Agreement provides that Pieris may continue the license by paying the Company an additional maintenance fee in the amount of $750,000 by May 31, 2016. In the event that Pieris does not pay this maintenance fee by May 31, 2016, the License Agreement expires and the license granted thereunder automatically terminates. If Pieris elects to continue the license and pays the Company the maintenance fee, the License Agreement provides that Pieris shall also receive a twelve-month option to license intellectual property of the Company related to an additional antibody program on the same terms and conditions as for the ENUM 388D4 family of anti-PD-1 antibodies (the Subsequent Option). In the event that Pieris exercises the Subsequent Option, Pieris will pay the Company an additional undisclosed license fee. The Company recognized $316,018 of collaboration revenue for the three month period ended March 31, 2016. The Company recognized $209,635 of collaboration revenue for the three month period ended March 31, 2015. Grant Revenue In September 2014, the Company was awarded a Phase II Small Business Innovation Research contract from National Cancer Institute (NCI), a unit of the National Institutes of Health, for up to $999,967 over two years. Grant revenue consists of a portion of the funds received to date by the NCI. Revenue is recognized as the related research services are performed in accordance with the terms of the agreement. The Company recognized $118,439 of grant revenue associated with the Phase II NCI grant for the three month period ended March 31, 2016. The Company recognized $65,087 of grant revenue associated with the Phase II NCI grant for the three month period ended March 31, 2015. The difference between the total consideration received to date and the revenue recognized is recorded as deferred revenue. Deferred revenue totaled $87,026 as of March 31, 2016 and $130,539 as of December 31, 2015. Research and Development Expenses Research and development expenditures are charged to the unaudited condensed consolidated statement of operations and comprehensive income (loss) as incurred. Research and development expenses are comprised of costs incurred in performing research and development activities, including salaries and benefits, facilities costs, clinical supply costs, contract services, depreciation and amortization expense and other related costs. Costs associated with acquired technology, in the form of upfront fees or milestone payments, are charged to research and development expense as incurred. Legal fees incurred in connection with patent applications, along with fees associated with the license to the Companys core technology, are expensed as research and development expense. Derivative Liabilities The Companys derivative liabilities relate to (a) warrants to purchase an aggregate of 23,549,510 shares of the Companys common stock that were issued in connection with the PPO (as defined below in Note 10) and (b) warrants to purchase 41,659 shares of Enumeral Series A Preferred Stock that were issued in December 2011 and June 2012 pursuant to Enumerals debt financing arrangement with Square 1 Bank (as further described in Note 7) that were subsequently converted into warrants to purchase 66,574 shares of the Companys common stock in connection with the July 2014 Merger. Additional detail regarding these warrants can be found in Note 11 below. Due to the price protection provision included in the warrant agreements, the warrants were deemed to be liabilities and, therefore, the fair value of the warrants is recorded in the current liabilities section of the unaudited condensed consolidated balance sheet. As such, the outstanding warrants are revalued each reporting period with the resulting gains and losses recorded as the change in fair value of derivative liabilities on the unaudited condensed consolidated statements of operations and comprehensive income (loss). The Company used the Black-Scholes option-pricing model to estimate the fair values of the issued and outstanding warrants. As of January 1, 2016, the Company began using a blended average of the Companys historical volatility and the historical volatility of a group of similarly situated companies (as described in greater detail below) to calculate the expected volatility when valuing its derivative liabilities. Comprehensive Income (Loss) Other comprehensive income (loss) is comprised of unrealized holding gains and losses arising during the period on available-for-sale securities that are not other-than-temporarily impaired. The unrealized gains and losses are reported in accumulated other comprehensive income (loss), until sold or mature, at which time they are reclassified to earnings. The Company recognized no reclassifications out of accumulated other comprehensive loss or unrealized holding losses on available-for-sale securities for the three month period ended March 31, 2016. The Company recognized unrealized holding losses on available-for-sale securities of $6,590 and reclassified $6 out of accumulated other comprehensive loss to net income for the three months ended March 31, 2015. Stock-Based Compensation The Company accounts for its stock-based compensation awards to employees and directors in accordance with FASB ASC Topic 718, Compensation Stock Compensation Equity, The Company estimates the fair value of its stock options using the Black-Scholes option pricing model, which requires the input of subjective assumptions, including (a) the expected stock price volatility, (b) the expected term of the award, (c) the risk-free interest rate, (d) expected dividends, and (e) the estimated fair value of its common stock on the measurement date. As of January 1, 2016, the Company began using a blended average of the Companys historical volatility and the historical volatility of a group of similarly situated companies to calculate the expected volatility when valuing its stock options. For purposes of calculating this blended volatility, the Company selected companies with comparable characteristics to it, including enterprise value, risk profiles, position within the industry, and with historical share price information sufficient to meet the expected term of the stock-based awards. The Company computes historical volatility data using the daily closing prices for the Companys and the selected companies shares during the equivalent period of the calculated expected term of the stock-based awards. Prior to January 1, 2016, due to the lack of a public market for the trading of its common stock and a lack of company specific historical and implied volatility data, the Company has based its estimate of expected volatility only on the historical volatility of a group of similarly situated companies that were publicly traded. Due to the lack of Company specific historical option activity, the Company has estimated the expected term of its employee stock options using the simplified method, whereby, the expected term equals the arithmetic average of the vesting term and the original contractual term of the option. The expected term for non-employee awards is the remaining contractual term of the option. The risk-free interest rates are based on the U.S. Treasury securities with a maturity date commensurate with the expected term of the associated award. The Company has never paid dividends and does not expect to pay dividends in the foreseeable future. The fair value of the restricted stock awards granted to employees is based upon the fair value of the common stock on the date of grant. Expense is recognized over the vesting period. The Company has recorded stock-based compensation expense of $333,811 and $166,391 for the three months ended March 31, 2016 and 2015, respectively. The Company has an aggregate of $1,359,863 of unrecognized stock-based compensation expense as of March 31, 2016 to be amortized over a weighted average period of 2.9 years. Effective January 1, 2016, the Company has elected to account for forfeitures as they occur, as permitted by ASU 2016-09, CompensationStock Compensation (Topic 718), Improvements to Employee Share-Based Payment Accounting Prior to the adoption of ASU 2016-09, the Company estimated the number of stock-based awards that were expected to vest, and only recognized compensation expense for such awards. The estimation of stock-based awards that will ultimately vest required judgment, and to the extent actual results or updated estimates differed from current estimates, such amounts were recorded as a cumulative adjustment in the period estimates were revised. The Company considered many factors when estimating expected forfeitures, including type of awards granted, employee class, and historical experience. Earnings (Loss) Per Share Basic earnings (loss) per common share amounts are based on the weighted average number of common shares outstanding. Diluted earnings (loss) per common share amounts are based on the weighted average number of common shares outstanding, plus the incremental shares that would have been outstanding upon the assumed exercise of all potentially dilutive stock options, warrants and convertible debt, subject to anti-dilution limitations. As of March 31, 2016 and 2015, the number of shares underlying options and warrants that were anti-dilutive were approximately 31.7 million and 25.5 million, respectively. Income Taxes Income taxes are recorded in accordance with FASB ASC Topic 740, Income Taxes The Company has no uncertain tax liabilities as of March 31, 2016 or December 31, 2015. The guidance requires the Company to determine whether it is more likely than not that a tax position will be sustained upon examination by the appropriate taxing authority. If a tax position meets the more likely than not recognition criteria, the guidance requires the tax position be measured at the largest amount of benefit greater than 50% likely of being realized upon ultimate settlement. Recent Accounting Pronouncements In May 2014, the FASB issued Accounting Standards Update (ASU) No. 2014-09, Revenue from Contracts with Customers (Topic 606) Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date, Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing. In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements Going Concern (Subtopic 205-40) In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) Accounting Standards Adopted in the Period In March 2016 the FASB issued ASU 2016-09, which simplified several aspects of employee share-based payment accounting. In particular, the ASU permits entities to make an accounting policy election to either estimate forfeitures on share-based payment awards, as previously required, or to recognize forfeitures as they occur. Effective January 1, 2016, the Company elected to recognize forfeitures as they occur. The impact of that change in accounting policy has been recorded as an $8,333 cumulative effect adjustment to accumulated deficit, as of December 31, 2015. The Company expects that it will recognize slightly higher share-based payment expense for the remainder of 2016, relative to prior periods, as the effects of forfeitures will not be recognized until they occur, rather than being estimated at the time of grant and subsequently adjusted as and when necessary. The effects of adopting the remaining provisions in ASU 2016-09 affecting the income tax consequences of share-based payments, classification of awards as either equity or liabilities when an entity partially settles the award in cash in excess of the employers minimum statutory withholding requirements and classification in the statement of cash flows did not have any impact on the Companys financial position, results of operations or cash flows. Other accounting standards that have been issued by the FASB or other standards-setting bodies that do not require adoption until a future date are not expected to have a material impact on the Companys unaudited condensed consolidated financial statements upon adoption. |
PROPERTY AND EQUIPMENT, NET
PROPERTY AND EQUIPMENT, NET | 3 Months Ended |
Mar. 31, 2016 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY AND EQUIPMENT, NET | 4 - PROPERTY AND EQUIPMENT, NET Property and equipment, net consist of the following: March 31, December 31, 2016 2015 Laboratory equipment $ 2,559,986 $ 2,559,986 Computer/office equipment and software 187,337 187,337 Furniture, fixtures and office equipment 73,734 73,734 Leasehold improvements 75,262 75,262 2,896,319 2,896,319 Less - Accumulated depreciation and amortization (1,570,681 ) (1,384,826 ) $ 1,325,638 $ 1,511,493 Depreciation and amortization expense for the three months ended March 31, 2016 and 2015 was $185,855 and $136,298, respectively. During the three months ended March 31, 2015, the Company expensed $22,962 associated with the write-down of leasehold improvements due to a relocation of the Companys corporate office and research laboratories in March 2015 (see Note 8). No such write-downs occurred during the three months ended March 31, 2016. |
RESTRICTED CASH
RESTRICTED CASH | 3 Months Ended |
Mar. 31, 2016 | |
Restricted Cash and Investments [Abstract] | |
RESTRICTED CASH | 5 RESTRICTED CASH The Company held $534,780 in restricted cash as of March 31, 2016 and December 31, 2015, respectively. The balances are primarily held on deposit with a bank to collateralize a standby letter of credit in the name of the Companys facility lessor in accordance with the Companys facility lease agreement. |
ACCRUED EXPENSES
ACCRUED EXPENSES | 3 Months Ended |
Mar. 31, 2016 | |
Other Income and Expenses [Abstract] | |
ACCRUED EXPENSES | 6 - ACCRUED EXPENSES The Companys accrued expenses consist of the following: March 31, December 31, 2016 2015 Accrued wages and benefits $ 470,539 $ 447,769 Accrued professional fees 117,571 213,475 Accrued other 59,962 53,140 Total accrued expenses $ 648,072 $ 714,384 |
DEBT
DEBT | 3 Months Ended |
Mar. 31, 2016 | |
Debt Disclosure [Abstract] | |
DEBT | 7 DEBT Equipment Lease Financing In December 2015, the Company and Fountain Leasing 2013 LP (Fountain) entered into a master lease agreement and related transaction documents, pursuant to which Fountain provided the Company with $506,944 for the purchase of research and development lab equipment (the Fountain Lease). Fountains security under the Fountain Lease is the equipment purchased and a security deposit in the amount of $101,389. The initial term of the Fountain Lease is 36 months, with payments of $21,545 per month for the first 24 months and then $1,267 for the 12 months thereafter. Pursuant to the terms of the Fountain Lease, the Company has an option at the end of the initial term to purchase the equipment for the greater of $25,347 or current fair market value, provided that such amount shall not be in excess of $152,083. In addition, the Company also has the option to extend the Fountain Lease for an additional 12 month period at a rate of $8,872 per month with the right at the end of such extension term to purchase the equipment for fair value or to return the equipment to Fountain. The Fountain Lease has a lease rate factor of 4.25% per month for the first 24 months and 0.25% for the final 12 months of the initial term. The Company has recorded current equipment lease financing of $243,215 and long-term equipment lease financing of $204,629 as of March 31, 2016. The Company has recorded current equipment lease financing of $240,473 and long-term equipment lease financing of $266,471 as of December 31, 2015. The equipment has been included in property and equipment on the Companys unaudited condensed consolidated balance sheets. Future principal payments on the equipment lease financing are as follows: For the twelve months ended March 31, Amount 2017 $ 258,542 2018 197,708 2019 11,406 Total equipment lease financing payments 467,656 Current equipment lease financing 258,541 Less: Amount representing interest (15,326 ) Current equipment lease financing, net 243,215 Long-term equipment lease financing 209,114 Less: Amount representing interest (4,485 ) Equipment lease financing, less current portion, net $ 204,629 |
COMMITMENTS
COMMITMENTS | 3 Months Ended |
Mar. 31, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS | 8 COMMITMENTS Operating Leases In March 2015, the Company relocated its offices and research laboratories to 200 CambridgePark Drive in Cambridge, Massachusetts. The Company is leasing 16,825 square feet at this facility (the Premises) pursuant to Indenture of Lease (the Lease) that the Company entered into in November 2014. The term of the Lease is for five years, and the initial base rent is $42.50 per square foot, or approximately $715,062 on an annual basis. The base rent will increase incrementally over the term of the Lease, reaching approximately $804,739 on an annual basis in the fifth year of the term. In addition, the Company is obligated to pay a proportionate share of the operating expenses and applicable taxes associated with the premises, as calculated pursuant to the terms of the Lease. The Company is also obligated to deliver a security deposit to the landlord in the amount of $529,699, either in the form of cash or an irrevocable letter of credit, which may be reduced to $411,988 following the second anniversary of the commencement date under the Lease, provided that the Company meets certain financial conditions set forth in the Lease. The Company has recorded deferred rent in connection with the CambridgePark Lease as of March 31, 2016 and December 31, 2015 in the amount of $46,106 and $36,847, respectively. This amount has been recorded as a long-term liability on the Companys unaudited condensed consolidated balance sheet. The Company previously occupied offices and research laboratories in approximately 4,782 square feet of space at One Kendall Square in Cambridge, Massachusetts, at an annual rent of $248,664 (the Kendall Lease). For the year ended December 31, 2015, the Company recorded an expense of $55,352, representing all exit costs associated with its move to new offices and research laboratories in March 2015. For the three months ended March 31, 2015, the Company recorded an accrual of $55,352 for exit costs associated with its move to new offices and research laboratories in March 2015. The amount accrued at March 31, 2015 includes rent paid for April and May of 2015 related to the Kendall Lease. In June 2015, Enumeral entered into a lease termination agreement with the landlord for Enumerals former facility at One Kendall Square, pursuant to which the Kendall Lease was terminated as of June 17, 2015. In accordance with the terms of the lease termination agreement, Enumeral is not obligated to pay rent for the One Kendall Square facility after May 31, 2015. Enumeral had maintained a security deposit relating to the facility, recorded as restricted cash on the unaudited condensed consolidated balance sheet as of March 31, 2015. This security deposit was returned to Enumeral pursuant to the lease termination agreement. In addition, the Company maintains a small corporate office at 1370 Broadway in New York, New York, at a current annual rate of $23,100. The lease for the Companys New York office expires on December 31, 2016. Rent expense was $332,339 and $155,264 for the three months ended March 31, 2016 and 2015, respectively. Future operating lease commitments as of March 31, 2016 are as follows: For the twelve months ended March 31, Amount 2017 $ 755,760 2018 760,532 2019 783,302 2020 737,678 $ 3,037,272 Employment Agreements The Company has employment agreements with members of management which contain minimum annual salaries and severance benefits if terminated prior to the term of the agreements. |
LICENSE AGREEMENT AND RELATED-P
LICENSE AGREEMENT AND RELATED-PARTY TRANSACTIONS | 3 Months Ended |
Mar. 31, 2016 | |
Related Party Transactions [Abstract] | |
LICENSE AGREEMENT AND RELATED-PARTY TRANSACTIONS | 9 LICENSE AGREEMENT AND RELATED-PARTY TRANSACTIONS License Agreement In April 2011, Enumeral licensed certain intellectual property from the Massachusetts Institute of Technology (MIT), then a related party (as one of Enumerals scientific co-founders was an employee of MIT), pursuant to an Exclusive License Agreement (the License Agreement), in exchange for the payment of upfront license fees and a commitment to pay annual license fees, patent costs, milestone payments, royalties on sublicense income and, upon product commercialization, royalties on the sales of products covered by the licenses or income from corporate partners, and the issuance of 66,303 shares of Enumeral common stock. This intellectual property portfolio includes patents owned by Harvard University or co-owned by MIT and The Whitehead Institute, or MIT and Massachusetts General Hospital. All amounts incurred related to the license fees have been expensed as research and development expenses by Enumeral as incurred. The Company incurred $10,000 and $7,500 in the three months ended March 31, 2016 and 2015, respectively. In addition to potential future royalty and milestone payments that Enumeral may have to pay MIT per the terms of the License Agreement, Enumeral is obligated to pay an annual fee of $40,000 in 2016, and $50,000 every year thereafter unless the License Agreement is terminated. During the year ended December 31, 2015, the Company achieved the first milestone in the Merck Agreement and paid MIT the required percentage of the milestone payment pursuant to the terms of the License Agreement. No royalty payments have been payable as Enumeral has not commercialized any products as set forth in the License Agreement. Enumeral reimburses the costs to MIT and Harvard University for the continued prosecution of the licensed patent estate. For the three months ended March 31, 2016 and 2015, Enumeral paid $134,645 and $98,212 for MIT and $5,278 and $18,487 for Harvard, respectively. The Company had accounts payable and accrued expenses of $65,706 and $168,726 associated with the reimbursement of costs to MIT and Harvard as of March 31, 2016 and December 31, 2015, respectively. The License Agreement also contained a provision whereby after the date upon which $7,500,000 of funding which was met in April of 2013, MIT and other licensing institutions set forth in the License Agreement have a right to participate in certain future equity issuances by Enumeral. In addition, pursuant to that provision Enumeral may have to issue additional shares to MIT and other licensing institutions set forth in the License Agreement if Enumeral issues common stock at a price per share that is less than the fair market value per share of the common stock issued to MIT and such licensing institutions based upon a weighted average formula set forth in the License Agreement. In March 2013, Enumeral and MIT entered into a first amendment to the License Agreement to clarify how equity issuances were to be made thereunder. In July 2014, Enumeral and MIT entered into a second amendment to the License Agreement, pursuant to which MITs participation rights and anti-dilution rights under the license agreement were terminated. Other than the exchange of Enumerals common stock for the Companys common stock in connection with the Merger, the Company did not issue any shares of common stock to MIT and such other licensing institutions in connection with the License Agreement in 2014. In April 2015, Enumeral and MIT entered into a third amendment to the License Agreement, which revised the timetable for Enumeral to complete certain diligence obligations relating to the initiation of clinical studies in support of obtaining regulatory approval of a Diagnostic Product (as such term is defined in the License Agreement), as well as the timetable by which Enumeral is required to make the first commercial sale of a Diagnostic Product. In April 2016, Enumeral and MIT entered into a fourth amendment to the License Agreement, which revised the timetable for Enumeral to complete certain diligence obligations relating to the establishment of sublicenses and/or corporate partner agreements for the development of Licensed Products and/or Diagnostic Products, as well as the timetable by which an Investigational New Drug Application shall be filed on a Therapeutic Product (as such terms are defined in the Agreement). Consulting Agreements In September 2014, the Company and Dr. Buckland entered into a Scientific Advisory Board Agreement (the SAB Agreement), which replaced Dr. Bucklands previous consulting agreement and pursuant to which Dr. Buckland serves as chairman of the Companys Scientific Advisory Board. The SAB Agreement has a term of two years. Pursuant to the terms of the SAB Agreement, Dr. Buckland will receive compensation on an hourly or per diem basis, either in cash or, at Dr. Bucklands election, in options to purchase the Companys common stock. The SAB Agreement limits the total amount of compensation payable to Dr. Buckland at $100,000 over any rolling 12-month period. During the three months ended March 31, 2016 and 2015, the Company recognized $0 and $11,000 of expense related to the SAB agreement, respectively. |
EQUITY
EQUITY | 3 Months Ended |
Mar. 31, 2016 | |
Equity [Abstract] | |
EQUITY | 10 EQUITY Common Stock On April 8, 2014, Enumeral amended its certificate of incorporation to increase the number of authorized shares of common stock from 15,000,000 to 24,000,000. In April 2014, Enumeral issued 948,823 shares of Series B Convertible Preferred Stock at an issue price of $2.125 per share for proceeds of $1,597,860, net of issuance costs of $418,390. The Series B Preferred Stock ranks pari passu in all respects to Enumerals Series A-2, Series A-1 and Series A Preferred Stock. In connection with this offering, Enumeral paid the placement agent $81,000 in cash and issued the placement agent a warrant to purchase 38,259 Series B shares exercisable at $2.125 per share for a term of five years. These costs were included in the total issuance costs. All shares and warrants were converted as part of the Merger (see Merger discussion below). In April 2014, Enumeral issued warrants to two executive officers to purchase 105,881 shares of Convertible Preferred Series B shares in connection with Enumerals Series B financing. These warrants were issued in relation to these executives taking a salary reduction prior to the Series B round of financing. In connection with the Merger in July 2014, these warrants were converted into warrants to purchase 309,967 shares of the Companys common stock (see Merger discussion below). On July 31, 2014, Enumeral entered into the Merger Agreement, pursuant to which Enumeral became a wholly owned subsidiary of the Company. The Companys authorized capital stock currently consists of 300,000,000 shares of common stock, par value $0.001, and 10,000,000 shares of blank check preferred stock, par value $0.001. Merger As a result of the Merger, all issued and outstanding common and preferred shares of Enumeral were exchanged for common shares of the Company as follows: (a) each share of Enumerals common stock issued and outstanding immediately prior to the closing of the Merger was converted into 1.102121 shares of the Companys common stock for a total of 4,940,744 shares post-Merger, (b) each share of Enumerals Series A Preferred Stock issued and outstanding immediately prior to the closing of the Merger was converted into 1.598075 shares of the Companys common stock for a total of 4,421,744 shares post-Merger, (c) each share of Enumerals Series A-1 Preferred Stock issued and outstanding immediately prior to the closing of the Merger was converted into 1.790947 shares of the Companys common stock for a total of 3,666,428 shares post-Merger, (d) each share of Enumerals Series A-2 Preferred Stock issued and outstanding immediately prior to the closing of the Merger was converted into 1.997594 shares of the Companys common stock for a total of 3,663,177 shares post-Merger, (e) each share of Enumerals Series B Preferred Stock issued and outstanding immediately prior to the closing of the Merger was converted into 2.927509 shares of the Companys common stock for a total of 2,777,687 shares post-Merger and (f) a convertible note and accrued interest was converted into 3,230,869 shares of the Companys common stock post-Merger. As a result of the Merger and Split-Off, the Company discontinued its pre-Merger business and acquired the business of Enumeral, and has continued the existing business operations of Enumeral as a publicly-traded company under the name Enumeral Biomedical Holdings, Inc. In accordance with reverse merger accounting treatment, historical financial statements for Enumeral Biomedical Holdings Inc. as of period ends, and for periods ended, prior to the Merger will be replaced with the historical financial statements of Enumeral prior to the Merger in all future filings with the SEC. Private Placement On July 31, 2014, the Company closed a private placement offering (the PPO) of 21,549,510 Units of securities, at a purchase price of $1.00 per Unit, each Unit consisting of one share of the Companys common stock and a warrant to purchase one share of the Companys common stock at an exercise price of $2.00 per share with a term of five years (the PPO Warrants). The net proceeds received from the PPO were $18,255,444. The investors in the PPO (for so long as they hold shares of the Companys common stock) have anti-dilution protection on the shares of common stock included in the Units purchased in the PPO and not subsequently transferred or sold (other than transfers to trusts or affiliates of such investors for the purpose of estate planning) in the event that within two years after the closing of the PPO the Company issues common stock or securities convertible into or exercisable for shares of the Companys common stock at a price lower than the Unit purchase price. The anti-dilution protection provisions are subject to exceptions for certain issuances, including but not limited to (a) shares of common stock issued in an underwritten public offering, (b) issuances of awards under the Companys 2014 Equity Incentive Plan, and (c) other exempt issuances. In addition, the PPO Warrants not subsequently transferred or sold (other than transfers to trusts or affiliates of such investors for the purpose of estate planning) have anti-dilution protection in the event that prior to the warrant expiration date the Company issues common stock or securities convertible into or exercisable for shares of the Companys common stock at a price lower than the warrant exercise price, subject to the exceptions described above. The Company agreed to pay the placement agents in the offering, registered broker-dealers, a cash commission of 10% of the gross funds raised from investors in the PPO. In addition, the placement agents received warrants exercisable for a period of five years to purchase a number of shares of the Companys common stock equal to 10% of the number of shares of common stock with a per share exercise price of $1.00 (the Agent Warrants); provided, however, that the placement agents were not entitled to any warrants on the sale of Units in excess of 20,000,000. Any sub-agent of the placement agents that introduced investors to the PPO was entitled to share in the cash fees and warrants attributable to those investors as described above. The Company also reimbursed the placement agents $30,000 in the aggregate for legal expenses incurred by the placement agents counsels in connection with the PPO, as described in the private placement agreements. As a result of the foregoing, the placement agents were paid an aggregate cash commission of $2,154,951 and were issued Agent Warrants to purchase 2,000,000 shares of the Companys common stock. The Agent Warrants not subsequently transferred or sold (other than transfers to trusts or affiliates of such investors for the purpose of estate planning) have anti-dilution protection until the warrant expiration date, subject to the exceptions described above for the Units. The value ascribed to the Agent Warrants are carried at fair value and reported as a derivative liability on the accompanying unaudited condensed consolidated balance sheets. The Company incurred approximately $500,000 of expenses in connection with the offering outside of the placement agent commissions and issued the subagent to one of the placement agents 150,000 shares of the Companys common stock. In addition, the Merger Agreement provided certain anti-dilution protection to the holders of the Companys common stock immediately prior to the Merger (after giving effect to the Split-Off), in the event that the aggregate number of units sold in the PPO after the final closing thereof were to exceed 15,000,000. Accordingly, based on the final amount of gross proceeds raised in the PPO, the Company issued 1,690,658 additional shares of the Companys common stock to holders of the Companys common stock immediately prior to the Merger. The Company recorded $1,690,658 in other expense related to this issuance of shares at $1.00 per share. |
STOCK OPTIONS, RESTRICTED STOCK
STOCK OPTIONS, RESTRICTED STOCK AND WARRANTS | 3 Months Ended |
Mar. 31, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
STOCK OPTIONS, RESTRICTED STOCK AND WARRANTS | 11 - STOCK OPTIONS, RESTRICTED STOCK AND WARRANTS Stock Options In December 2009, Enumeral adopted the 2009 Stock Incentive Plan (the 2009 Plan). In April 2014, Enumeral amended the 2009 Plan to increase the number of shares authorized thereunder to 3,200,437. The 2009 Plan was terminated in July 2014 in connection with the Merger. On July 31, 2014, the Companys Board of Directors adopted, and the Companys stockholders approved, the 2014 Equity Incentive Plan (the 2014 Plan), which reserves a total of 8,100,000 shares of the Companys common stock for incentive awards. In connection with the Merger, options to purchase 948,567 shares of Enumeral common stock previously granted under the 2009 Plan were converted into options to purchase 1,045,419 shares of the Companys common stock under the 2014 Plan. Generally, shares that are expired, terminated, surrendered or cancelled without having been fully exercised will be available for future awards. In addition, shares of common stock that are tendered to the Company by a participant to exercise an award are added to the number of shares of common stock available for the grant of awards. Effective January 1, 2016, the Company recognizes all share-based awards under the straight-line attribution method, assuming that all granted awards will vest. Forfeitures will be recognized in the periods when they occur. Refer to Note 3, Summary of Significant Accounting Policies, for further information. In prior periods, ASC 718 required forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. The Company evaluated its forfeiture assumptions quarterly and the expected forfeiture rate was adjusted when necessary. The actual expense recognized over the vesting period is based on only those shares that vest. In periods prior to January 1, 2016, estimates of pre-vesting option forfeitures were based on the Companys experience. The Company used a forfeiture rate of 0 - 5% depending on when and to whom the options were granted. The Company adjusted its estimate of forfeitures over the requisite service period based on the extent to which actual forfeitures differ, or are expected to differ, from such estimates. Changes in estimated forfeitures were recognized through a cumulative adjustment in the period of change and may have impacted the amount of compensation expense to be recognized in future periods. The Company considered many factors when estimating expected forfeitures, including types of awards, employee class, and historical experience. The Company estimates the fair value of each stock award on the grant date using the Black-Scholes option-pricing model based on the following assumptions and the assumptions regarding the fair value of the underlying common stock on each measurement date: For the three Expected Volatility 117.0% Risk-free interest rate 1.39%-1.72% Expected term (in years) 5.00 Expected dividend yield 0% The Company did not grant any stock options during the three months ended March 31, 2015. As of March 31, 2016, there were 243,268 shares available for issuance under the 2014 Plan to eligible employees, non-employee directors and consultants. This number is subject to adjustment in the event of a stock split, reverse stock split, stock dividend, or other change in the Companys capitalization. A summary of stock option activity for the three months ended March 31, 2016 is as follows: Weighted- Weighted- Average Average Remaining Exercise Contractual Shares Price Term (years) Outstanding at December 31, 2015 5,926,654 $ 0.62 9.0 Granted 1,468,182 $ 0.20 Exercised - $ - Canceled (453,263) $ 0.85 Outstanding at March 31, 2016 6,941,573 $ 0.52 8.9 Exercisable at March 31, 2016 2,950,855 $ 0.49 8.6 Stock option compensation expense was $293,445 and $141,681 for the three months ended March 31, 2016 and 2015, respectively. The Company has an aggregate of $1,319,622 of unrecognized stock option compensation expense as of March 31, 2016 to be amortized over a weighted average period of 3.0 years. The aggregate intrinsic value of options exercisable as of March 31, 2016 was $4,133. The aggregate intrinsic value was calculated as the difference between the exercise price of the stock options and the fair value of the underlying common stock as of the unaudited condensed consolidated balance sheet date. Restricted Stock A summary of restricted stock activity for the three months ended March 31, 2016 is as follows: Weighted- Number of Average Grant Shares Date Fair Value Balance of unvested restricted stock at December 31, 2015 282,119 $ 0.24 Issuance of restricted stock 140,910 $ 0.22 Vested (213,197) $ 0.23 Balance of unvested restricted stock at March 31, 2016 209,832 $ 0.23 Restricted stock compensation expense was $40,366 and $24,710 for the three months ended March 31, 2016 and 2015, respectively. The Company has an aggregate of $40,241 of unrecognized restricted stock compensation expense as of March 31, 2016 to be amortized over a weighted average period of 0.5 years. Warrants As of March 31, 2016, there were a total of 24,803,409 warrants outstanding to purchase shares of the Company's common stock. Of these, 23,549,510 warrants were issued in connection with the PPO and 66,574 warrants were issued to Square 1 Bank (in connection with a previous financing transaction as further described below) and are accounted for as derivative liabilities. The remaining 1,187,325 warrants do not require derivative liability accounting treatment. Derivative Liability Warrants In connection with the PPO, the Company issued warrants to purchase an aggregate of 23,549,510 shares of the Companys common stock. Additionally, in connection with Enumerals December 2011 financing transaction with Square 1 Bank, Enumeral issued warrants to purchase 41,659 shares of Enumerals Series A preferred stock that were subsequently converted into warrants to purchase 66,574 shares of the Companys common stock in connection with the July 2014 Merger. A) PPO and Agent Warrants In July 2014, the Company issued warrants to purchase 23,549,510 shares of the Companys common stock in connection with the PPO, of which warrants to purchase 21,549,510 shares of the Companys common stock had an exercise price of $2.00 per share and were issued to the investors in the PPO, and warrants to purchase 2,000,000 shares of the Companys common stock had an exercise price of $1.00 per share and were issued to the placement agents for the PPO (or their affiliates). The estimated fair value of the warrants at the time of issuance was determined to be $16,261,784 using the Black-Scholes pricing model and the following assumptions: expected term of five years, 105.4% volatility, and a risk-free rate of 1.77%. The estimated fair value of the warrants at March 31, 2016 was determined to be $1,455,450 using the Black-Scholes pricing model and the following assumptions: expected remaining term of 3.33 years, 114.6% volatility, risk-free rate of 0.93%, and no expected dividends. The estimated fair value of the warrants at December 31, 2015 was determined to be $2,130,822 using the Black-Scholes pricing model and the following assumptions: expected remaining term of 3.58 years, 109.4% volatility, risk-free rate of 1.44%, and no expected dividends. Due to a price protection provision included in the warrant agreements, the warrants were deemed to be a liability and, therefore, the fair value of the warrants is recorded in the liability section of the unaudited condensed consolidated balance sheet. As such, the outstanding warrants are revalued each reporting period with the resulting gains and losses recorded as the change in fair value of derivative liabilities on the unaudited condensed consolidated statements of operations and comprehensive income (loss). All 23,549,510 warrants were outstanding as of March 31, 2016 and December 31, 2015, respectively. B) Square 1 Financing In connection with the December 2011 Square 1 financing transaction, Enumeral issued to Square 1 Bank warrants to purchase an aggregate of 33,944 shares of Series A convertible preferred stock at an exercise price of $1.16 per share, exercisable for seven years. In July 2014, as part of the Merger, these warrants were converted into warrants to purchase 54,245 shares of the Companys common stock at an exercise price of $0.73 per share. The estimated fair value of the warrants as of March 31, 2016 was determined to be $3,308 using the Black-Scholes pricing model and the following assumptions: expected term of 2.68 years, 114.6% volatility, and a risk-free rate of 0.84%. The estimated fair value of the warrants as of December 31, 2015 was determined to be $5,777 using the Black-Scholes pricing model and the following assumptions: expected term of 2.9 years, 104.6% volatility, and a risk-free rate of 1.31%. As part of a June 12, 2012 amendment to the Loan and Security Agreement between Enumeral and Square 1 Bank, Enumeral issued warrants to Square 1 Bank to purchase an aggregate of 7,715 shares of Series A convertible preferred stock at an exercise price of $1.16 per share, exercisable for seven years. In July 2014, as part of the Merger, these warrants were converted into warrants to purchase 12,329 shares of the Companys common stock at an exercise price of $0.73 per share. The estimated fair value of these warrants as of March 31, 2016 was determined to be $898 using the Black-Scholes pricing model and the following assumptions: expected term of 3.2 years, 114.6% volatility, and a risk-free rate of 0.96%. The estimated fair value of these warrants as of December 31, 2015 was determined to be $1,492 using the Black-Scholes pricing model and the following assumptions: expected term of 3.5 years, 104.6% volatility, and a risk-free rate of 1.42%. The warrants are classified as derivative liabilities in the accompanying unaudited condensed consolidated balance sheets and measured at fair value on a recurring basis. As such, the outstanding warrants are revalued each reporting period with the resulting gains and losses recorded as the change in fair value of derivative liabilities on the unaudited condensed consolidated statements of operations and comprehensive income (loss). As of March 31, 2016 and December 31, 2015 these warrants were outstanding and expire on December 5, 2018 and June 12, 2019. |
CONCENTRATIONS
CONCENTRATIONS | 3 Months Ended |
Mar. 31, 2016 | |
Risks and Uncertainties [Abstract] | |
CONCENTRATIONS | 12 CONCENTRATIONS During the three months ended March 31, 2016, the Company recorded revenue from two entities in excess of 10% of the Companys total revenue in the amounts of $316,018 and $118,439, which represents 73% and 27% of the Companys total revenue for that period. During the three months ended March 31, 2015, the Company recorded revenue from two entities in excess of 10% of the Companys total revenue in the amounts of $209,635 and $65,087, which represents 76% and 24% of the Companys total revenue for that period. As of March 31, 2016, accounts receivable consisted of amounts due from two entities which represented 81% and 19% of the Companys total outstanding accounts receivable balance, respectively. As of December 31, 2015, accounts receivable consisted of amounts due from two entities which represented 67% and 33% of the Companys total outstanding accounts receivable balance, respectively. |
SUMMARY OF SIGNIFICANT ACCOUN18
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 3 Months Ended |
Mar. 31, 2016 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated financial statements were prepared using generally accepted accounting principles for interim financial information and the instructions to Form 10-Q and Regulation S-X. Accordingly, these unaudited condensed consolidated financial statements do not include all information or notes required by generally accepted accounting principles for annual financial statements and should be read in conjunction with the 2015 Financial Statements as filed on the Company's Annual Report on Form 10-K for the year ended December 31, 2015, which was filed with the SEC on March 30, 2016. The preparation of the unaudited condensed consolidated financial statements in conformity with these accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the unaudited condensed consolidated financial statements and the reported amounts of expenses during the reported period. Ultimate results could differ from the estimates of management. In the opinion of management, the unaudited condensed consolidated financial statements included herein contain all adjustments necessary to present fairly the Company's financial position as of March 31, 2016 and the results of its operations and cash flows for the three months ended March 31, 2016 and 2015. Such adjustments are of a normal recurring nature. The results of operations for the three months ended March 31, 2016 may not be indicative of results for the full year. |
Principles of Consolidation | Principles of Consolidation The unaudited condensed consolidated financial statements include the accounts of the Company and its subsidiaries, Enumeral Biomedical Corp. and Enumeral Securities Corporation. In these unaudited condensed consolidated financial statements, subsidiaries are companies that are wholly owned, the accounts of which are consolidated with those of the Company. Intercompany transactions and balances are eliminated in consolidation. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with maturities of 90 days or less from the purchase date to be cash equivalents. Cash and cash equivalents are held in depository and money market accounts and are reported at fair value. |
Concentration of Credit Risk | Concentration of Credit Risk The Company has no significant off-balance sheet concentrations of credit risk such as foreign currency exchange contracts, option contracts or other hedging arrangements. Financial instruments that subject the Company to credit risk consist primarily of cash and cash equivalents. The Company generally invests its cash in money market funds, U.S. Treasury securities and U.S. Agency securities that are subject to minimal credit and market risk. Management has established guidelines relative to credit ratings and maturities intended to safeguard principal balances and maintain liquidity. At times, the Companys cash balances may exceed the current insured amounts under the Federal Deposit Insurance Corporation. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Fair values of financial instruments included in current assets and current liabilities are estimated to approximate their book values, due to the short maturity of such instruments. All debt is based on current rates at which the Company could borrow funds with similar remaining maturities and approximates fair value. The Companys assets and liabilities that are measured at fair value on a recurring basis are measured in accordance with the Financial Accounting Standards Boards (FASB) Accounting Standards Codification (ASC) Topic 820, Fair Value Measurements and Disclosures The valuation hierarchy is based upon the transparency of inputs to the valuation of an asset or liability as of the measurement date. The three levels are defined as follows: Level 1 Level 2 Level 3 The Companys cash equivalents, carried at fair value, are comprised of investments in federal agency backed money market funds. The valuation of the Companys derivative liabilities is discussed below and in Note 11. The following table presents information about the Companys financial assets and liabilities measured at fair value on a recurring basis as of March 31, 2016 and December 31, 2015: March 31, 2016 Quoted Prices in Active Markets (Level 1) Observable Inputs (Level 2) Unobservable Inputs (Level 3) Assets Cash $ 755,354 $ 755,354 $ - $ - Money Market funds, included in cash equivalents $ 1,081,950 $ 1,081,950 $ - $ - Liabilities Derivative liabilities $ 1,459,656 $ - $ - $ 1,459,656 December 31, 2015 Quoted Prices in Active Markets (Level 1) Observable Inputs (Level 2) Unobservable Inputs (Level 3) Assets Cash $ 815,890 $ 815,890 $ - $ - Money Market funds, included in cash equivalents $ 2,780,372 $ 2,780,372 $ - $ - Liabilities Derivative liabilities $ 2,138,091 $ - $ - $ 2,138,091 The following table provides a roll forward of the fair value of the Companys derivative liabilities, using Level 3 inputs: Balance as of December 31, 2015 $ 2,138,091 Change in fair value (678,435) Balance as of March 31, 2016 $ 1,459,656 |
Accounts Receivable and Allowance for Doubtful Accounts | Accounts Receivable and Allowance for Doubtful Accounts Trade receivables are recorded at the invoiced amount. The Company maintains allowances for doubtful accounts, if needed, for estimated losses resulting from the inability of customers to make required payments. This allowance is based on specific customer account reviews and historical collections experience. There was no allowance for doubtful accounts as of March 31, 2016 or December 31, 2015. |
Property and Equipment | Property and Equipment Property and equipment are recorded at cost. Expenditures for maintenance and repairs are charged to expense as incurred, whereas major betterments are capitalized as additions to property and equipment. Depreciation is provided using the straight-line method over the estimated useful lives of the assets as follows: Lab equipment 3-5 years Computer equipment and software 3 years Furniture 3 years Leasehold improvements Shorter of useful life or life of the lease |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets Long-lived assets are reviewed for impairment annually or whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. When such events occur, the Company compares the carrying amounts of the assets to their undiscounted expected future cash flows. If this comparison indicated that there is impairment, the amount of the impairment is calculated as the difference between the carrying value and fair value. There have been no impairments recognized during the three months ended March 31, 2016 and 2015, respectively. |
Revenue Recognition - Collaboration and license revenue | Revenue Recognition Collaboration and license revenue Non-refundable license fees are recognized as revenue when the Company has a contractual right to receive such payment, the contract price is fixed or determinable, the collection of the resulting receivable is reasonably assured and the Company has no further performance obligations under the license agreement. Multiple element arrangements, such as license and development arrangements are analyzed to determine whether the deliverables, which often include license and performance obligations such as research and steering committee services, can be separated or whether they must be accounted for as a single unit of accounting in accordance with GAAP. The Company recognizes up-front license payments as revenue upon delivery of the license only if the license has stand-alone value and the fair value of the undelivered performance obligations, typically including research and/or steering committee services, can be determined. If the fair value of the undelivered performance obligations can be determined, such obligations would then be accounted for separately as performed. If the license is considered to either (i) not have stand-alone or (ii) have stand-alone value but the fair value of any of the undelivered performance obligations cannot be determined, the arrangement would then be accounted for as a single unit of accounting and the license payments and payments for performance obligations are recognized as revenue over the estimated period of when the performance obligations are performed. Whenever the Company determines that an arrangement should be accounted for as a single unit of accounting, it must determine the period over which the performance obligations will be performed and revenue will be recognized. Revenue will be recognized using either a relative performance or straight-line method. The Company recognizes revenue using the relative performance method provided that it can reasonably estimate the level of effort required to complete its performance obligations under an arrangement and such performance obligations are provided on a best-efforts basis. Direct labor hours or full-time equivalents are typically used as a measure of performance. Revenue recognized under the relative performance method would be determined by multiplying the total payments under the contract, excluding royalties and payments contingent upon achievement of substantive milestones, by the ratio of level of effort incurred to date to estimated total level of effort required to complete the Companys performance obligations under the arrangement. Revenue is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using the relative performance method, as of each reporting period. If the Company cannot reasonably estimate the level of effort required to complete its performance obligations under an arrangement, the performance obligations are provided on best-efforts basis and the Company can reasonably estimate when the performance obligation ceases or the remaining obligations become inconsequential and perfunctory. At that time, the total payments under the arrangement, excluding royalties and payments contingent upon achievement of substantive milestones, would be recognized as revenue on a straight-line basis over a period the Company expects to complete its performance obligations. Revenue is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using the straight-line basis, as of the period ending date. In December 2014, the Company entered into a study agreement with Merck Sharp & Dohme Corp., or Merck (the Merck Agreement). In February 2016, the Company and Merck subsequently amended the work plan under the Merck Agreement to also include non-small cell lung cancer tissues. Pursuant to the Merck Agreement, the Company is conducting a specified research program using its platform technology to identify functional response of single cell types in colorectal cancer and non-small cell lung cancer in the presence or absence of immunomodulatory receptor modulators identified by Merck. In this collaboration, Merck is reimbursing the Company for the cost of performing the work plan set forth in the Merck Agreement, for up to a specified number of full-time employees at a pre-determined annual rate. In addition, Merck will make certain milestone payments to the Company upon the completion of specified objectives set forth in the Merck Agreement and related work plan. In September 2015, the Company announced the achievement of the first milestone under the Merck Agreement. In January 2016, the Company and The University of Texas M.D. Anderson Cancer Center (MDACC) entered into a Collaborative Research and Development Agreement (the MDACC Agreement). Under the MDACC Agreement, the Company and MDACC plan to collaborate on the discovery and development of novel monoclonal antibodies against selected targets in immune-oncology, utilizing the Companys antibody discovery and immune profiling platform and MDACCs preclinical and development expertise and infrastructure. Pursuant to the terms of the MDACC Agreement, the Company and MDACC will share the costs of research and development activities necessary to take development candidates through successful completion of a Phase I clinical trial. The MDACC Agreement provides for a structure whereby the Company and MDACC are each granted the right to receive a percentage of the net income from product sales or any payments associated with licensing or otherwise partnering a program with a third party. In April 2016, the Company entered into a License and Transfer Agreement (the License Agreement) with Pieris Pharmaceuticals, Inc. and Pieris Pharmaceuticals GmbH (collectively, Pieris). Pursuant to the terms and conditions of the License Agreement, Pieris is licensing from the Company specified intellectual property related to the Companys anti-PD-1 antibody program ENUM 388D4 for the potential development and commercialization by Pieris of novel multispecific therapeutic proteins comprising fusion proteins based on Pieris Anticalins ® Under the License Agreement, Pieris paid the Company a $250,000 initial license fee. The License Agreement provides that Pieris may continue the license by paying the Company an additional maintenance fee in the amount of $750,000 by May 31, 2016. In the event that Pieris does not pay this maintenance fee by May 31, 2016, the License Agreement expires and the license granted thereunder automatically terminates. If Pieris elects to continue the license and pays the Company the maintenance fee, the License Agreement provides that Pieris shall also receive a twelve-month option to license intellectual property of the Company related to an additional antibody program on the same terms and conditions as for the ENUM 388D4 family of anti-PD-1 antibodies (the Subsequent Option). In the event that Pieris exercises the Subsequent Option, Pieris will pay the Company an additional undisclosed license fee. The Company recognized $316,018 of collaboration revenue for the three month period ended March 31, 2016. The Company recognized $209,635 of collaboration revenue for the three month period ended March 31, 2015. |
Grant Revenue | Grant Revenue In September 2014, the Company was awarded a Phase II Small Business Innovation Research contract from National Cancer Institute (NCI), a unit of the National Institutes of Health, for up to $999,967 over two years. Grant revenue consists of a portion of the funds received to date by the NCI. Revenue is recognized as the related research services are performed in accordance with the terms of the agreement. The Company recognized $118,439 of grant revenue associated with the Phase II NCI grant for the three month period ended March 31, 2016. The Company recognized $65,087 of grant revenue associated with the Phase II NCI grant for the three month period ended March 31, 2015. The difference between the total consideration received to date and the revenue recognized is recorded as deferred revenue. Deferred revenue totaled $87,026 as of March 31, 2016 and $130,539 as of December 31, 2015. |
Research and Development Expenses | Research and Development Expenses Research and development expenditures are charged to the unaudited condensed consolidated statement of operations and comprehensive income (loss) as incurred. Research and development expenses are comprised of costs incurred in performing research and development activities, including salaries and benefits, facilities costs, clinical supply costs, contract services, depreciation and amortization expense and other related costs. Costs associated with acquired technology, in the form of upfront fees or milestone payments, are charged to research and development expense as incurred. Legal fees incurred in connection with patent applications, along with fees associated with the license to the Companys core technology, are expensed as research and development expense. |
Derivative Liabilities | Derivative Liabilities The Companys derivative liabilities relate to (a) warrants to purchase an aggregate of 23,549,510 shares of the Companys common stock that were issued in connection with the PPO (as defined below in Note 10) and (b) warrants to purchase 41,659 shares of Enumeral Series A Preferred Stock that were issued in December 2011 and June 2012 pursuant to Enumerals debt financing arrangement with Square 1 Bank (as further described in Note 7) that were subsequently converted into warrants to purchase 66,574 shares of the Companys common stock in connection with the July 2014 Merger. Additional detail regarding these warrants can be found in Note 11 below. Due to the price protection provision included in the warrant agreements, the warrants were deemed to be liabilities and, therefore, the fair value of the warrants is recorded in the current liabilities section of the unaudited condensed consolidated balance sheet. As such, the outstanding warrants are revalued each reporting period with the resulting gains and losses recorded as the change in fair value of derivative liabilities on the unaudited condensed consolidated statements of operations and comprehensive income (loss). The Company used the Black-Scholes option-pricing model to estimate the fair values of the issued and outstanding warrants. As of January 1, 2016, the Company began using a blended average of the Companys historical volatility and the historical volatility of a group of similarly situated companies (as described in greater detail below) to calculate the expected volatility when valuing its derivative liabilities. |
Comprehensive Income (Loss) | Comprehensive Income (Loss) Other comprehensive income (loss) is comprised of unrealized holding gains and losses arising during the period on available-for-sale securities that are not other-than-temporarily impaired. The unrealized gains and losses are reported in accumulated other comprehensive income (loss), until sold or mature, at which time they are reclassified to earnings. The Company recognized no reclassifications out of accumulated other comprehensive loss or unrealized holding losses on available-for-sale securities for the three month period ended March 31, 2016. The Company recognized unrealized holding losses on available-for-sale securities of $6,590 and reclassified $6 out of accumulated other comprehensive loss to net income for the three months ended March 31, 2015. |
Stock-Based Compensation | Stock-Based Compensation The Company accounts for its stock-based compensation awards to employees and directors in accordance with FASB ASC Topic 718, Compensation Stock Compensation Equity, The Company estimates the fair value of its stock options using the Black-Scholes option pricing model, which requires the input of subjective assumptions, including (a) the expected stock price volatility, (b) the expected term of the award, (c) the risk-free interest rate, (d) expected dividends, and (e) the estimated fair value of its common stock on the measurement date. As of January 1, 2016, the Company began using a blended average of the Companys historical volatility and the historical volatility of a group of similarly situated companies to calculate the expected volatility when valuing its stock options. For purposes of calculating this blended volatility, the Company selected companies with comparable characteristics to it, including enterprise value, risk profiles, position within the industry, and with historical share price information sufficient to meet the expected term of the stock-based awards. The Company computes historical volatility data using the daily closing prices for the Companys and the selected companies shares during the equivalent period of the calculated expected term of the stock-based awards. Prior to January 1, 2016, due to the lack of a public market for the trading of its common stock and a lack of company specific historical and implied volatility data, the Company has based its estimate of expected volatility only on the historical volatility of a group of similarly situated companies that were publicly traded. Due to the lack of Company specific historical option activity, the Company has estimated the expected term of its employee stock options using the simplified method, whereby, the expected term equals the arithmetic average of the vesting term and the original contractual term of the option. The expected term for non-employee awards is the remaining contractual term of the option. The risk-free interest rates are based on the U.S. Treasury securities with a maturity date commensurate with the expected term of the associated award. The Company has never paid dividends and does not expect to pay dividends in the foreseeable future. The fair value of the restricted stock awards granted to employees is based upon the fair value of the common stock on the date of grant. Expense is recognized over the vesting period. The Company has recorded stock-based compensation expense of $333,811 and $166,391 for the three months ended March 31, 2016 and 2015, respectively. The Company has an aggregate of $1,359,863 of unrecognized stock-based compensation expense as of March 31, 2016 to be amortized over a weighted average period of 2.9 years. Effective January 1, 2016, the Company has elected to account for forfeitures as they occur, as permitted by ASU 2016-09, CompensationStock Compensation (Topic 718), Improvements to Employee Share-Based Payment Accounting Prior to the adoption of ASU 2016-09, the Company estimated the number of stock-based awards that were expected to vest, and only recognized compensation expense for such awards. The estimation of stock-based awards that will ultimately vest required judgment, and to the extent actual results or updated estimates differed from current estimates, such amounts were recorded as a cumulative adjustment in the period estimates were revised. The Company considered many factors when estimating expected forfeitures, including type of awards granted, employee class, and historical experience. |
Earnings (Loss) Per Share | Earnings (Loss) Per Share Basic earnings (loss) per common share amounts are based on the weighted average number of common shares outstanding. Diluted earnings (loss) per common share amounts are based on the weighted average number of common shares outstanding, plus the incremental shares that would have been outstanding upon the assumed exercise of all potentially dilutive stock options, warrants and convertible debt, subject to anti-dilution limitations. As of March 31, 2016 and 2015, the number of shares underlying options and warrants that were anti-dilutive were approximately 31.7 million and 25.5 million, respectively. |
Income Taxes | Income Taxes Income taxes are recorded in accordance with FASB ASC Topic 740, Income Taxes The Company has no uncertain tax liabilities as of March 31, 2016 or December 31, 2015. The guidance requires the Company to determine whether it is more likely than not that a tax position will be sustained upon examination by the appropriate taxing authority. If a tax position meets the more likely than not recognition criteria, the guidance requires the tax position be measured at the largest amount of benefit greater than 50% likely of being realized upon ultimate settlement. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In May 2014, the FASB issued Accounting Standards Update (ASU) No. 2014-09, Revenue from Contracts with Customers (Topic 606) Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date, Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing. In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements Going Concern (Subtopic 205-40) In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) |
Accounting Standards Adopted in the Period | Accounting Standards Adopted in the Period In March 2016 the FASB issued ASU 2016-09, which simplified several aspects of employee share-based payment accounting. In particular, the ASU permits entities to make an accounting policy election to either estimate forfeitures on share-based payment awards, as previously required, or to recognize forfeitures as they occur. Effective January 1, 2016, the Company elected to recognize forfeitures as they occur. The impact of that change in accounting policy has been recorded as an $8,333 cumulative effect adjustment to accumulated deficit, as of December 31, 2015. The Company expects that it will recognize slightly higher share-based payment expense for the remainder of 2016, relative to prior periods, as the effects of forfeitures will not be recognized until they occur, rather than being estimated at the time of grant and subsequently adjusted as and when necessary. The effects of adopting the remaining provisions in ASU 2016-09 affecting the income tax consequences of share-based payments, classification of awards as either equity or liabilities when an entity partially settles the award in cash in excess of the employers minimum statutory withholding requirements and classification in the statement of cash flows did not have any impact on the Companys financial position, results of operations or cash flows. Other accounting standards that have been issued by the FASB or other standards-setting bodies that do not require adoption until a future date are not expected to have a material impact on the Companys unaudited condensed consolidated financial statements upon adoption. |
SUMMARY OF SIGNIFICANT ACCOUN19
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Accounting Policies [Abstract] | |
Schedule of Assets and Liabilities Measured at Fair Value on a Recurring Basis | The following table presents information about the Companys financial assets and liabilities measured at fair value on a recurring basis as of March 31, 2016 and December 31, 2015: March 31, 2016 Quoted Prices in Active Markets (Level 1) Observable Inputs (Level 2) Unobservable Inputs (Level 3) Assets Cash $ 755,354 $ 755,354 $ - $ - Money Market funds, included in cash equivalents $ 1,081,950 $ 1,081,950 $ - $ - Liabilities Derivative liabilities $ 1,459,656 $ - $ - $ 1,459,656 December 31, 2015 Quoted Prices in Active Markets (Level 1) Observable Inputs (Level 2) Unobservable Inputs (Level 3) Assets Cash $ 815,890 $ 815,890 $ - $ - Money Market funds, included in cash equivalents $ 2,780,372 $ 2,780,372 $ - $ - Liabilities Derivative liabilities $ 2,138,091 $ - $ - $ 2,138,091 |
Schedule of Warrant Liabilities | The following table provides a roll forward of the fair value of the Companys derivative liabilities, using Level 3 inputs: Balance as of December 31, 2015 $ 2,138,091 Change in fair value (678,435) Balance as of March 31, 2016 $ 1,459,656 |
Schedule of Estimated Useful Lives | Depreciation is provided using the straight-line method over the estimated useful lives of the assets as follows: Lab equipment 3-5 years Computer equipment and software 3 years Furniture 3 years Leasehold improvements Shorter of useful life or life of the lease |
PROPERTY AND EQUIPMENT, NET (Ta
PROPERTY AND EQUIPMENT, NET (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment, Net | Property and equipment, net consist of the following: March 31, December 31, 2016 2015 Laboratory equipment $ 2,559,986 $ 2,559,986 Computer/office equipment and software 187,337 187,337 Furniture, fixtures and office equipment 73,734 73,734 Leasehold improvements 75,262 75,262 2,896,319 2,896,319 Less - Accumulated depreciation and amortization (1,570,681 ) (1,384,826 ) $ 1,325,638 $ 1,511,493 |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Other Income and Expenses [Abstract] | |
Schedule of accrued expenses and other current liabities | The Companys accrued expenses consist of the following: March 31, December 31, 2016 2015 Accrued wages and benefits $ 470,539 $ 447,769 Accrued professional fees 117,571 213,475 Accrued other 59,962 53,140 Total accrued expenses $ 648,072 $ 714,384 |
DEBT (Tables)
DEBT (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Debt Disclosure [Abstract] | |
Schedule of future principal payments | Future principal payments on the equipment lease financing are as follows: For the twelve months ended March 31, Amount 2017 $ 258,542 2018 197,708 2019 11,406 Total equipment lease financing payments 467,656 Current equipment lease financing 258,541 Less: Amount representing interest (15,326 ) Current equipment lease financing, net 243,215 Long-term equipment lease financing 209,114 Less: Amount representing interest (4,485 ) Equipment lease financing, less current portion, net $ 204,629 |
COMMITMENTS (Tables)
COMMITMENTS (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Operating Lease Commitments | Future operating lease commitments as of March 31, 2016 are as follows: For the twelve months ended March 31, Amount 2017 $ 755,760 2018 760,532 2019 783,302 2020 737,678 $ 3,037,272 |
STOCK OPTIONS, RESTRICTED STO24
STOCK OPTIONS, RESTRICTED STOCK AND WARRANTS (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Summary of Estimates Fair Value Of Each Stock | The Company estimates the fair value of each stock award on the grant date using the Black-Scholes option-pricing model based on the following assumptions and the assumptions regarding the fair value of the underlying common stock on each measurement date: For the three Expected Volatility 117.0% Risk-free interest rate 1.39%-1.72% Expected term (in years) 5.00 Expected dividend yield 0% |
Summary of Stock Option Activity | A summary of stock option activity for the three months ended March 31, 2016 is as follows: Weighted- Weighted- Average Average Remaining Exercise Contractual Shares Price Term (years) Outstanding at December 31, 2015 5,926,654 $ 0.62 9.0 Granted 1,468,182 $ 0.20 Exercised - $ - Canceled (453,263) $ 0.85 Outstanding at March 31, 2016 6,941,573 $ 0.52 8.9 Exercisable at March 31, 2016 2,950,855 $ 0.49 8.6 |
Summary of Restricted Stock Activity | A summary of restricted stock activity for the three months ended March 31, 2016 is as follows: Weighted- Number of Average Grant Shares Date Fair Value Balance of unvested restricted stock at December 31, 2015 282,119 $ 0.24 Issuance of restricted stock 140,910 $ 0.22 Vested (213,197) $ 0.23 Balance of unvested restricted stock at March 31, 2016 209,832 $ 0.23 |
NATURE OF BUSINESS (Narrative)
NATURE OF BUSINESS (Narrative) (Details) | Jul. 31, 2014$ / sharesshares | Jul. 31, 2014$ / sharesshares |
Number of shares held by pre-merger majority stockholder cancelled pursuant to the Split-Off Agreement | shares | 23,100,000 | |
Private Placement [Member] | ||
Number of units of securities sold | shares | 21,549,510 | 21,549,510 |
Sales price per unit of securities sold | $ / shares | $ 1 | $ 1 |
Exercise price of warrants | $ / shares | $ 2 | $ 2 |
Term of warrants | 5 years |
GOING CONCERN (Narrative) (Deta
GOING CONCERN (Narrative) (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2016 | Dec. 31, 2015 | |
Risks and Uncertainties [Abstract] | ||
Working capital | $ 469,423 | $ 615,530 |
Derivative liabilities | 1,459,656 | 2,138,091 |
Accumulated defict | 15,964,028 | $ 14,408,976 |
Maintenance fee | $ 750,000 |
SUMMARY OF SIGNIFICANT ACCOUN27
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Narrative) (Details) - USD ($) | 1 Months Ended | 3 Months Ended | |||||
Sep. 30, 2014 | Mar. 31, 2016 | Mar. 31, 2015 | Dec. 31, 2015 | Jun. 12, 2013 | Jun. 30, 2012 | Dec. 31, 2011 | |
License fee | $ 250,000 | ||||||
Maintenance fee | 750,000 | ||||||
Collaboration revenue | 316,018 | $ 209,635 | |||||
Grant Revenue | |||||||
Grant revenue from small business innovation research contract | $ 999,967 | ||||||
Grant revenue | 118,439 | 65,087 | |||||
Deferred revenue | 87,026 | $ 130,539 | |||||
Stock-Based Compensation | |||||||
Stock-based compensation expense | 333,811 | $ 166,391 | |||||
Unrecognized stock-based compensation | $ 1,359,863 | ||||||
Unrecognized stock-based compensation, period for recognition | 2 years 10 months 24 days | ||||||
Number of shares underlying options and warrants that were anti-dilutive | 31,700,000 | 25,500,000 | |||||
Unrealized holding losses on available-for-sale securities | $ 6,590 | ||||||
Reclassification for loss included in net income | $ 6 | ||||||
Common Stock [Member] | |||||||
Stock-Based Compensation | |||||||
Warrants to purchase shares of the common stock issued | 23,549,510 | ||||||
Series A Preferred Stock [Member] | |||||||
Stock-Based Compensation | |||||||
Warrants to purchase shares of the common stock issued | 41,659 | ||||||
Square One Bank [Member] | |||||||
Stock-Based Compensation | |||||||
Warrants to purchase shares of the common stock issued | 66,574 | 66,574 | |||||
Square One Bank [Member] | Series A Preferred Stock [Member] | |||||||
Stock-Based Compensation | |||||||
Warrants to purchase shares of the common stock issued | 7,715 | ||||||
Restricted Stock [Member] | |||||||
Stock-Based Compensation | |||||||
Unrecognized stock-based compensation | $ 40,241 | ||||||
Unrecognized stock-based compensation, period for recognition | 6 months |
SUMMARY OF SIGNIFICANT ACCOUN28
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Schedule of Assets and Liabilities Measured at Fair Value on a Recurring Basis) (Details) - Fair Value, Measurements, Recurring [Member] - USD ($) | Mar. 31, 2016 | Dec. 31, 2015 |
Assets | ||
Cash | $ 755,354 | $ 815,890 |
Money Market funds, included in cash equivalents | 1,081,950 | 2,780,372 |
Liabilities | ||
Derivative liabilities | 1,459,656 | 2,138,091 |
Fair Value, Inputs, Level 1 [Member] | ||
Assets | ||
Cash | 755,354 | 815,890 |
Money Market funds, included in cash equivalents | 1,081,950 | 2,780,372 |
Liabilities | ||
Derivative liabilities | 0 | 0 |
Fair Value, Inputs, Level 2 [Member] | ||
Assets | ||
Cash | 0 | 0 |
Money Market funds, included in cash equivalents | 0 | 0 |
Liabilities | ||
Derivative liabilities | 0 | 0 |
Fair Value, Inputs, Level 3 [Member] | ||
Assets | ||
Cash | 0 | 0 |
Money Market funds, included in cash equivalents | 0 | 0 |
Liabilities | ||
Derivative liabilities | $ 1,459,656 | $ 2,138,091 |
SUMMARY OF SIGNIFICANT ACCOUN29
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Schedule of Warrant Liabilities) (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Balance at December 31, 2015 | $ 2,138,091 | |
Change in fair value | 678,435 | $ 4,669,884 |
Balance as of March 31, 2016 | 1,459,656 | |
Fair Value, Inputs, Level 3 [Member] | ||
Balance at December 31, 2015 | 2,138,091 | |
Change in fair value | (678,435) | |
Balance as of March 31, 2016 | $ 1,459,656 |
SUMMARY OF SIGNIFICANT ACCOUN30
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Schedule of Estimated Useful Lives) (Details) | 3 Months Ended |
Mar. 31, 2016 | |
Laboratory equipment [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property and Equipment, useful life | 5 years |
Laboratory equipment [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property and Equipment, useful life | 3 years |
Computer/office equipment and software [Member] | |
Property, Plant and Equipment [Line Items] | |
Property and Equipment, useful life | 3 years |
Furniture, fixtures and office equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Property and Equipment, useful life | 3 years |
Leasehold Improvements [Member] | |
Property, Plant and Equipment [Line Items] | |
Property and Equipment, useful life, term | Shorter of useful life or life of the lease |
PROPERTY AND EQUIPMENT, NET (Na
PROPERTY AND EQUIPMENT, NET (Narrative) (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation and amortization | $ 185,855 | $ 136,298 |
Carrying value of leasehold improvements | $ 22,962 |
PROPERTY AND EQUIPMENT, NET (Sc
PROPERTY AND EQUIPMENT, NET (Schedule of Property and Equipment) (Details) - USD ($) | Mar. 31, 2016 | Dec. 31, 2015 |
Property, Plant and Equipment [Line Items] | ||
Cost | $ 2,896,319 | $ 2,896,319 |
Less - Accumulated depreciation and amortization | (1,570,681) | (1,384,826) |
Property and equipment, net | 1,325,638 | 1,511,493 |
Laboratory equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Cost | 2,559,986 | 2,559,986 |
Computer/office equipment and software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Cost | 187,337 | 187,337 |
Furniture, fixtures and office equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Cost | 73,734 | 73,734 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Cost | $ 75,262 | $ 75,262 |
RESTRICTED CASH (Narrative) (De
RESTRICTED CASH (Narrative) (Details) - USD ($) | Mar. 31, 2016 | Dec. 31, 2015 |
Restricted Cash and Investments [Abstract] | ||
Restricted cash | $ 534,780 | $ 534,780 |
ACCRUED EXPENSES (Details)
ACCRUED EXPENSES (Details) - USD ($) | Mar. 31, 2016 | Dec. 31, 2015 |
Accrued Expenses Details | ||
Accrued wages and benefits | $ 470,539 | $ 447,769 |
Accrued professional fees | 117,571 | 213,475 |
Accrued other | 59,962 | 53,140 |
Total accrued expenses | $ 648,072 | $ 714,384 |
DEBT (Details)
DEBT (Details) | Mar. 31, 2016USD ($) |
Debt Disclosure [Abstract] | |
2,017 | $ 258,542 |
2,018 | 197,708 |
2,019 | 11,406 |
Total equipment lease financing payments | 467,656 |
Current equipment lease financing | 258,541 |
Less: Amount representing interest | (15,326) |
Current equipment lease financing, net | 243,215 |
Long-term equipment lease financing | 209,114 |
Less: Amount representing interest | (4,485) |
Equipment lease financing, less current portion, net | $ 204,629 |
DEBT (Narrative) (Details)
DEBT (Narrative) (Details) - USD ($) | 1 Months Ended | |
Dec. 31, 2015 | Mar. 31, 2016 | |
Debt Instrument [Line Items] | ||
Current equipment lease financing | $ 240,473 | $ 243,215 |
Long-term equipment lease financing | 266,471 | $ 204,629 |
Equipment Lease Financing [Member] | ||
Debt Instrument [Line Items] | ||
Purchase of research and development lab equipment | 506,944 | |
Security deposit | $ 101,389 | |
Description of Lessee Leasing Arrangements, Capital Leases | The initial term of the Fountain Lease is 36 months, with payments of $21,545 per month for the first 24 months and then $1,267 for the 12 months thereafter. Pursuant to the terms of the Fountain Lease, the Company has an option at the end of the initial term to purchase the equipment for the greater of $25,347 or current fair market value, provided that such amount shall not be in excess of $152,083. In addition, the Company also has the option to extend the Fountain Lease for an additional 12 month period at a rate of $8,872 per month with the right at the end of such extension term to purchase the equipment for fair value or to return the equipment to Fountain. The Fountain Lease has a lease rate factor of 4.25% per month for the first 24 months and 0.25% for the final 12 months of the initial term. |
COMMITMENTS (Details)
COMMITMENTS (Details) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |
Nov. 30, 2014USD ($)ft² | Mar. 31, 2016USD ($)ft² | Mar. 31, 2015USD ($) | Dec. 31, 2015USD ($) | |
Operating Leased Assets [Line Items] | ||||
Initial base rent on an annual basis | $ 23,100 | |||
Lease expiration date | Dec. 31, 2016 | |||
Exit costs | $ 22,962 | |||
Rent expense | $ 332,339 | $ 155,264 | ||
Deferred rent | 46,106 | $ 36,847 | ||
Future operating lease commitments: | ||||
2,017 | 755,760 | |||
2,018 | 760,532 | |||
2,019 | 783,302 | |||
2,020 | 737,678 | |||
Total future minimum payments due | $ 3,037,272 | |||
Kendall Lease [Member] | ||||
Operating Leased Assets [Line Items] | ||||
Square footage of leased property | ft² | 4,782 | |||
Initial base rent on an annual basis | $ 248,664 | |||
Lease expiration date | Jun. 17, 2015 | |||
Exit costs | $ 55,352 | $ 55,352 | ||
Rent expense | $ 248,664 | |||
Office Lease Two [Member] | ||||
Operating Leased Assets [Line Items] | ||||
Lease term | 5 years | |||
Square footage of leased property | ft² | 16,825 | |||
Initial base rent per square foot | 42.3 | |||
Initial base rent on an annual basis | $ 715,062 | |||
Maximum initial base rent on an annual basis | 804,739 | |||
Security deposit agreed to delivered to Landlord | 529,699 | |||
Security Deposit Following Second Anniversary of Term Commencement Date | $ 411,988 |
LICENSE AGREEMENT AND RELATED38
LICENSE AGREEMENT AND RELATED-PARTY TRANSACTIONS (Narrative) (Details) - USD ($) | 1 Months Ended | 3 Months Ended | |||
Apr. 30, 2011 | Mar. 31, 2016 | Mar. 31, 2015 | Dec. 31, 2015 | Apr. 30, 2013 | |
Related Party Transaction [Line Items] | |||||
Research and development | $ 1,470,043 | $ 1,230,504 | |||
Accounts payable and accrued expenses | 65,706 | $ 168,726 | |||
Licensing Agreements [Member] | |||||
Related Party Transaction [Line Items] | |||||
Issuance of common stock - license agreement, shares | 66,303 | ||||
Barry Buckland PhD [Member] | Scientific Advisory Board Agreement [Member] | |||||
Related Party Transaction [Line Items] | |||||
Consulting agreement, payment amount | 100,000 | ||||
Massachusetts Institute Of Technology [Member] | Licensing Agreements [Member] | |||||
Related Party Transaction [Line Items] | |||||
Research and development | 10,000 | 7,500 | |||
Royalty and milestone payments, 2016 | 40,000 | ||||
Royalty and milestone payments, due every year thereafter | 50,000 | ||||
Payments for reimbursements | 134,645 | 98,212 | |||
Funding requirement of capital stock | $ 7,500,000 | ||||
Harvard [Member] | Licensing Agreements [Member] | |||||
Related Party Transaction [Line Items] | |||||
Payments for reimbursements | 5,278 | 18,487 | |||
Consultants [Member] | |||||
Related Party Transaction [Line Items] | |||||
Consulting agreement expense | $ 0 | $ 11,000 |
EQUITY (Common Stock) (Details)
EQUITY (Common Stock) (Details) - USD ($) | 1 Months Ended | |||||
Apr. 30, 2014 | Mar. 31, 2016 | Dec. 31, 2015 | Jul. 31, 2014 | Apr. 08, 2014 | Dec. 31, 2011 | |
Class of Stock [Line Items] | ||||||
Preferred stock, shares issued | 0 | 0 | ||||
Common stock, shares authorized | 300,000,000 | 300,000,000 | ||||
Common stock, par value | $ 0.001 | $ 0.001 | ||||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | ||||
Preferred stock, par value | $ 0.001 | $ 0.001 | ||||
Post Amendment [Member] | ||||||
Class of Stock [Line Items] | ||||||
Common stock, shares authorized | 24,000,000 | |||||
Pre Amendment [Member] | ||||||
Class of Stock [Line Items] | ||||||
Common stock, shares authorized | 15,000,000 | |||||
Placement Agents [Member] | ||||||
Class of Stock [Line Items] | ||||||
Stock issuance costs | $ 81,000 | |||||
Common Stock [Member] | ||||||
Class of Stock [Line Items] | ||||||
Number of shares callable from warrants | 23,549,510 | |||||
Series B Preferred Stock [Member] | ||||||
Class of Stock [Line Items] | ||||||
Preferred stock, shares issued | 948,823 | |||||
Equity issuance, price per share | $ 2.125 | |||||
Proceeds from Issuance of Convertible Preferred Stock | $ 1,597,860 | |||||
Stock issuance costs | $ 418,390 | |||||
Series B Preferred Stock [Member] | Placement Agents [Member] | ||||||
Class of Stock [Line Items] | ||||||
Number of shares callable from warrants | 38,259 | |||||
Exercise price of warrants | $ 2.125 | |||||
Term of warrants | 5 years | |||||
Series B Preferred Stock [Member] | Two Executive Officer [Member] | ||||||
Class of Stock [Line Items] | ||||||
Number of shares callable from warrants | 105,881 | |||||
Warrants Issued to Executive Officers [Member] | Common Stock [Member] | ||||||
Class of Stock [Line Items] | ||||||
Number of shares callable from warrants | 309,967 |
EQUITY (Merger) (Details)
EQUITY (Merger) (Details) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2015shares | Dec. 31, 2013shares | |
Common Stock [Member] | ||
Class of Stock [Line Items] | ||
Conversion ratio | 1.102121 | |
Number of shares issued | 4,940,744 | |
Number of shares issued upon conversion of convertible note and accrued interest | 3,663,177 | |
Common Stock [Member] | Merger [Member] | ||
Class of Stock [Line Items] | ||
Number of shares issued upon conversion of convertible note and accrued interest | 3,230,869 | |
Series A Preferred Stock [Member] | ||
Class of Stock [Line Items] | ||
Conversion ratio | 1.598075 | |
Number of shares issued | 4,421,744 | |
Series AOne Convertible Preferred Stock [Member] | ||
Class of Stock [Line Items] | ||
Conversion ratio | 1.790947 | |
Number of shares issued | 3,666,428 | |
Series ATwo Convertible Preferred Stock [Member] | ||
Class of Stock [Line Items] | ||
Conversion ratio | 1.997594 | |
Number of shares issued | 3,663,177 | |
Series B Preferred Stock [Member] | ||
Class of Stock [Line Items] | ||
Conversion ratio | 2.927509 | |
Number of shares issued | 2,777,687 |
EQUITY (Private Placement) (Det
EQUITY (Private Placement) (Details) - Private Placement [Member] | Jul. 31, 2014USD ($)$ / sharesshares |
Private Placement [Line Items] | |
Number of units of securities sold | 21,549,510 |
Sales price per unit of securities sold | $ / shares | $ 1 |
Exercise price of warrants | $ / shares | $ 2 |
Term of warrants | 5 years |
Holding term in which additional shares are issued to the holder | 2 years |
Proceeds received through private placement | $ | $ 18,255,444 |
Commission rate paid to placement agents expressed as a percentage of the gross funds raised from investors in the PPO | 10.00% |
Maximum number of unit sales that agents are entitled to receive warrant commissions | 20,000,000 |
Aggregate legal expenses that are reimbursable to placement agents in connection with private placement offering | $ | $ 30,000 |
Proceeds received through private placement | $ | $ 500,000 |
The maximum number of units that can be sold through private placement in order to provide certain anti-dilution protection to the holders of the Company's Common Stock immediately prior to the Merger (after giving effect to the Split-Off) | 15,000,000 |
Equity issuance, price per share | $ / shares | $ 1 |
Placement Agent [Member] | |
Private Placement [Line Items] | |
Exercise price of warrants | $ / shares | $ 1 |
Term of warrants | 5 years |
Payments for commissions | $ | $ 2,154,951 |
Number of common shares issued from warrants provided to placement agents | 2,000,000 |
Stock issued during period, shares | 150,000 |
Holders Of Companys Common Stock [Member] | |
Private Placement [Line Items] | |
Stock issued during period, shares | 1,690,658 |
Issuance cost | $ | $ 1,690,658 |
Equity issuance, price per share | $ / shares | $ 1 |
STOCK OPTIONS, RESTRICTED STO42
STOCK OPTIONS, RESTRICTED STOCK AND WARRANTS (Summary of estimates the fair value of each stock award) (Details) | 3 Months Ended |
Mar. 31, 2016 | |
Expected Volatility | 117.00% |
Expected term (in years) | 5 years |
Expected dividend yield | 0.00% |
Employee Stock Option [Member] | Minimum [Member] | |
Risk-free interest rate | 1.39% |
Employee Stock Option [Member] | Maximum [Member] | |
Risk-free interest rate | 1.72% |
STOCK OPTIONS, RESTRICTED STO43
STOCK OPTIONS, RESTRICTED STOCK AND WARRANTS (Summary of Stock Option Activity) (Details) - $ / shares | 3 Months Ended | 12 Months Ended |
Mar. 31, 2016 | Dec. 31, 2015 | |
Shares: | ||
Options outstanding at beginning of period | 5,926,654 | |
Granted | 1,468,182 | |
Exercised | 0 | |
Canceled | (453,263) | |
Options outstanding at end of period | 6,941,573 | 5,926,654 |
Options exercisable at end of period | 2,950,855 | |
Weighted-Average Exercise Price Per Share: | ||
Options outstanding at beginning of period | $ 0.62 | |
Granted | 0.20 | |
Exercised | 0 | |
Canceled | 0.85 | |
Options outstanding at end of period | 0.52 | $ 0.62 |
Options exercisable at end of period | $ 0.49 | |
Weighted-Average Remaining Contractual Term (Years) | ||
Options outstanding | 8 years 10 months 24 days | 9 years |
Options exercisable at end of period | 8 years 7 months 6 days |
STOCK OPTIONS, RESTRICTED STO44
STOCK OPTIONS, RESTRICTED STOCK AND WARRANTS (Summary of Restricted Stock Activity) (Details) - Restricted Stock [Member] | 3 Months Ended |
Mar. 31, 2016$ / sharesshares | |
Number of shares: | |
Balance of unvested restricted stock at December 31, 2015 | shares | 282,119 |
Issuance of restricted stock | shares | 140,910 |
Vested | shares | (213,197) |
Balance of unvested restricted stock at March 31, 2016 | shares | 209,832 |
Weighted Average Grant Date Fair Value: | |
Balance of unvested restricted stock at December 31, 2015 | $ / shares | $ 0.24 |
Issuance of restricted stock | $ / shares | 0.22 |
Vested | $ / shares | 0.23 |
Balance of unvested restricted stock at March 31, 2016 | $ / shares | $ 0.23 |
STOCK OPTIONS, RESTRICTED STO45
STOCK OPTIONS, RESTRICTED STOCK AND WARRANTS (Stock Options Narrative) (Details) - USD ($) | 3 Months Ended | ||||
Mar. 31, 2016 | Mar. 31, 2015 | Dec. 31, 2015 | Jul. 31, 2014 | Apr. 30, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Intrinsic value of stock options exercisable | $ 4,133 | ||||
Unrecognized stock-based compensation | $ 1,359,863 | ||||
Number of options granted during period | 1,468,182 | ||||
Stock-based compensation expense | $ 333,811 | $ 166,391 | |||
Options to purchase shares of common stock | 6,941,573 | 5,926,654 | |||
Equity Incentive Plan 2014 [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Options to purchase shares of common stock | 1,045,419 | ||||
Number of shares reserved for issuance under the plan | 8,100,000 | ||||
Equity Incentive Plan 2014 [Member] | Common Stock [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of shares available for issuance | 243,268 | ||||
Stock Incentive Plan 2009 [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Options to purchase shares of common stock | 948,567 | ||||
Stock Incentive Plan 2009 [Member] | Common Stock [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of shares reserved for issuance under the plan | 3,200,437 | ||||
Employee [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock-based compensation expense | $ 293,445 | $ 141,681 | |||
Vesting period | 3 years | ||||
Employee Stock Option [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Unrecognized stock-based compensation | 1,319,622 | ||||
Minimum [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Forfeiture rate | 0 | ||||
Maximum [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Forfeiture rate | $ 5 |
STOCK OPTIONS, RESTRICTED STO46
STOCK OPTIONS, RESTRICTED STOCK AND WARRANTS (Restricted Stock Narrative) (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Restricted stock expense | $ 40,366 | |
Unrecognized stock-based compensation | $ 1,359,863 | |
Unrecognized stock-based compensation, period for recognition | 2 years 10 months 24 days | |
Restricted Stock [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Restricted stock expense | $ 24,710 | |
Unrecognized stock-based compensation | $ 40,241 | |
Unrecognized stock-based compensation, period for recognition | 6 months |
STOCK OPTIONS, RESTRICTED STO47
STOCK OPTIONS, RESTRICTED STOCK AND WARRANTS (Warrants Narrative) (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||
Jul. 31, 2014 | Mar. 31, 2016 | Mar. 31, 2015 | Dec. 31, 2015 | Dec. 31, 2014 | Jul. 31, 2015 | Jun. 12, 2013 | Jun. 30, 2012 | Dec. 31, 2011 | |
Class of Warrant or Right [Line Items] | |||||||||
Class of Warrant or Right, Unissued | 1,187,325 | ||||||||
Warrants outstanding | 24,803,409 | ||||||||
Expected term | 5 years | ||||||||
Volatility rate | 117.00% | ||||||||
Stock based compensation expense | $ 333,811 | $ 166,391 | |||||||
Private Placement Offering and Agent Warrants [Member] | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Warrants outstanding | 23,549,510 | 23,549,510 | 23,549,510 | ||||||
Warrants to purchase shares of the common stock issued | 23,549,510 | 23,549,510 | |||||||
Fair value of warrants | $ 1,455,450 | $ 2,130,822 | $ 16,261,784 | ||||||
Expected term | 5 years | 3 years 3 months 29 days | 3 years 6 months 29 days | ||||||
Volatility rate | 105.40% | 114.60% | 109.40% | ||||||
Risk-free interest rate | 1.77% | 0.93% | 1.44% | ||||||
Warrants Issued to Placement Agents in Private Placement Offering [Member] | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Exercise price of warrants | $ 1 | ||||||||
Warrants to purchase shares of the common stock issued | 2,000,000 | ||||||||
Warrants Issued to Investors in Private Placement Offering [Member] | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Exercise price of warrants | $ 2 | ||||||||
Warrants to purchase shares of the common stock issued | 21,549,510 | ||||||||
Series A Preferred Stock [Member] | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Warrants to purchase shares of the common stock issued | 41,659 | ||||||||
Common Stock [Member] | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Warrants to purchase shares of the common stock issued | 23,549,510 | ||||||||
Financing And Security Agreement [Member] | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Warrants to purchase shares of the common stock issued | 41,659 | ||||||||
Square One Bank [Member] | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Warrants outstanding | 66,574 | ||||||||
Warrants to purchase shares of the common stock issued | 66,574 | 66,574 | |||||||
Fair value of warrants | $ 898 | $ 1,492 | |||||||
Expected term | 3 years 2 months 12 days | ||||||||
Volatility rate | 114.60% | ||||||||
Risk-free interest rate | 0.96% | ||||||||
Square One Bank [Member] | Series A Preferred Stock [Member] | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Exercise price of warrants | $ 1.16 | ||||||||
Warrants to purchase shares of the common stock issued | 7,715 | ||||||||
Square One Bank [Member] | Warrant [Member] | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Exercise price of warrants | $ 0.73 | ||||||||
Warrants to purchase shares of the common stock issued | 12,329 | ||||||||
Expected term | 3 years 6 months | ||||||||
Volatility rate | 104.60% | ||||||||
Risk-free interest rate | 1.42% | ||||||||
Square One Bank [Member] | Financing And Security Agreement [Member] | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Warrants to purchase shares of the common stock issued | 66,574 | ||||||||
Square One Bank [Member] | Financing And Security Agreement [Member] | Common Stock [Member] | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Warrants to purchase shares of the common stock issued | 66,574 | ||||||||
Lender [Member] | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Fair value of warrants | $ 3,308 | $ 5,777 | |||||||
Lender [Member] | Series A Preferred Stock [Member] | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Exercise price of warrants | $ 1.16 | ||||||||
Warrants to purchase shares of the common stock issued | 33,944 | ||||||||
Lender [Member] | Warrant [Member] | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Exercise price of warrants | $ 0.73 | ||||||||
Warrants to purchase shares of the common stock issued | 54,245 | ||||||||
Expected term | 2 years 8 months 5 days | 2 years 10 months 24 days | |||||||
Volatility rate | 114.60% | 104.60% | |||||||
Risk-free interest rate | 0.84% | 1.31% |
CONCENTRATIONS (Details)
CONCENTRATIONS (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | Dec. 31, 2015 | |
Concentration Risk [Line Items] | |||
Revenues | $ 434,457 | $ 274,722 | |
Sales Revenue, Net [Member] | |||
Concentration Risk [Line Items] | |||
Concentration risk percentage | 10.00% | 10.00% | |
Sales Revenue, Net [Member] | Major Customer One [Member] | |||
Concentration Risk [Line Items] | |||
Concentration risk percentage | 73.00% | 76.00% | |
Revenues | $ 316,018 | $ 209,635 | |
Sales Revenue, Net [Member] | Major Customer Two [Member] | |||
Concentration Risk [Line Items] | |||
Concentration risk percentage | 27.00% | 24.00% | |
Revenues | $ 118,439 | $ 65,087 | |
Accounts Receivable [Member] | Major Customer One [Member] | |||
Concentration Risk [Line Items] | |||
Concentration risk percentage | 81.00% | 67.00% | |
Accounts Receivable [Member] | Major Customer Two [Member] | |||
Concentration Risk [Line Items] | |||
Concentration risk percentage | 19.00% | 33.00% |