Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2016 | Nov. 08, 2016 | |
Document And Entity Information | ||
Entity Registrant Name | Enumeral Biomedical Holdings, Inc. | |
Entity Central Index Key | 1,561,551 | |
Document Type | 10-Q | |
Trading Symbol | ENUM | |
Document Period End Date | Sep. 30, 2016 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity a Well-known Seasoned Issuer | No | |
Entity a Voluntary Filer | No | |
Entity's Reporting Status Current | Yes | |
Entity Filer Category | Smaller Reporting Company | |
Entity Common Stock, Shares Outstanding | 52,073,481 | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2,016 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) | Sep. 30, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 1,893,414 | $ 3,596,262 |
Accounts receivable | 265,537 | 306,012 |
Prepaid expenses and other current assets | 213,386 | 280,479 |
Total current assets | 2,372,337 | 4,182,753 |
Property and equipment, net | 1,031,192 | 1,511,493 |
Other assets: | ||
Restricted cash | 534,780 | 534,780 |
Other assets | 111,556 | 114,572 |
Total assets | 4,049,865 | 6,343,598 |
Current liabilities: | ||
Accounts payable | 436,734 | 343,736 |
Accrued expenses | 485,449 | 714,384 |
Deferred revenue | 29,009 | 130,539 |
Equipment lease financing | 248,794 | 240,473 |
Promissory notes | 2,615,049 | |
Derivative liabilities | 905,666 | 2,138,091 |
Total current liabilities | 4,720,701 | 3,567,223 |
Deferred rent | 57,446 | 36,847 |
Long-term equipment lease financing | 78,822 | 266,471 |
Total liabilities | 4,856,969 | 3,870,541 |
Commitments and contingencies | ||
Stockholders' equity (deficiency): | ||
Preferred stock, $.001 par value; 10,000,000 shares authorized: -0- shares issued and outstanding as of September 30, 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 September 30, 2016 and December 31, 2015, respectively | 52,074 | 51,933 |
Additional paid-in-capital | 17,713,257 | 16,830,100 |
Accumulated deficit | (18,572,435) | (14,408,976) |
Total stockholders' equity (deficiency) | (807,104) | 2,473,057 |
Total liabilities and stockholders' equity (deficiency) | $ 4,049,865 | $ 6,343,598 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Sep. 30, 2016 | Dec. 31, 2015 |
Statement of Financial Position [Abstract] | ||
Preferred stock, at par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, authorized | 10,000,000 | 10,000,000 |
Preferred stock, issued | 0 | 0 |
Preferred stock, outstanding | 0 | 0 |
Common stock, at par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, authorized | 300,000,000 | 300,000,000 |
Common stock, issued | 52,073,481 | 51,932,571 |
Common stock, outstanding | 52,073,481 | 51,932,571 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Revenue: | ||||
Collaboration and license revenue | $ 226,115 | $ 395,448 | $ 1,878,599 | $ 894,132 |
Grant revenue | 94,696 | 88,377 | 375,641 | 245,728 |
Total revenue | 320,811 | 483,825 | 2,254,240 | 1,139,860 |
Cost of revenue and expenses: | ||||
Research and development | 1,026,317 | 1,798,241 | 3,737,161 | 4,833,911 |
General and administrative | 812,974 | 1,354,064 | 3,752,512 | 4,271,024 |
Total cost of revenue and expenses | 1,839,291 | 3,152,305 | 7,489,673 | 9,104,935 |
Loss from operations | (1,518,480) | (2,668,480) | (5,235,433) | (7,965,075) |
Other income (expense): | ||||
Interest income (expense) | (152,261) | 5,358 | (160,451) | 12,978 |
Change in fair value of derivative liabilities | 409,891 | 3,281,406 | 1,232,425 | 10,833,156 |
Total other income (expense), net | 257,630 | 3,286,764 | 1,071,974 | 10,846,134 |
Net income (loss) before income taxes | (1,260,850) | 618,284 | (4,163,459) | 2,881,059 |
Provision for income taxes | ||||
Net income (loss) | (1,260,850) | 618,284 | (4,163,459) | 2,881,059 |
Other comprehensive income (loss): | ||||
Reclassification for loss included in net income | 19,097 | |||
Net unrealized holding losses on available-for-sale securities arising during the period | (9,320) | |||
Comprehensive income (loss) | $ (1,260,850) | $ 618,284 | $ (4,163,459) | $ 2,890,836 |
Basic net income (loss) per share (in dollars per share) | $ (0.02) | $ 0.01 | $ (0.08) | $ 0.06 |
Diluted net income (loss) per share (in dollars per share) | $ (0.02) | $ 0.01 | $ (0.08) | $ 0.05 |
Weighted-average number of common shares attributable to common stockholders - basic (in shares) | 52,073,481 | 51,699,028 | 52,071,933 | 51,648,800 |
Weighted-average number of common shares attributable to common stockholders - diluted (in shares) | 52,073,481 | 52,986,588 | 52,071,933 | 53,727,593 |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 9 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Cash flows from operating activities: | ||
Net income (loss) | $ (4,163,459) | $ 2,881,059 |
Adjustments to reconcile net income (loss) to net cash used in operating activities: | ||
Depreciation and amortization | 480,301 | 425,788 |
Exit costs associated with write-off of net carrying value of leasehold improvements | 22,962 | |
Stock-based compensation | 883,298 | 477,666 |
Change in fair value of derivative liabilities | (1,232,425) | (10,833,156) |
Realized loss on marketable securities | 19,097 | |
Accretion of debt discount | 84,642 | |
Changes in operating assets and liabilities: | ||
Accounts receivable | 40,475 | (101,939) |
Prepaid expenses and other assets | 70,109 | (145,456) |
Accounts payable | 92,998 | 423,364 |
Accrued expenses and other liabilities | (228,935) | 454,843 |
Deferred rent | 20,599 | (6,623) |
Deferred revenue | (101,530) | (62,036) |
Net cash used in operating activities | (4,053,927) | (6,444,431) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (1,133,299) | |
Proceeds from sale of marketable securities | 3,000,799 | |
Receipt of security deposit | 27,630 | |
Net cash provided by investing activities | 1,895,130 | |
Cash flows from financing activities: | ||
Proceeds from issuance of promissory notes, net of issuance costs | 2,530,407 | |
Proceeds from the exercise of stock options | 29,675 | |
Payments on equipment lease financing | (179,328) | |
Net cash provided by financing activities | 2,351,079 | 29,675 |
Net decrease in cash and cash equivalents | (1,702,848) | (4,519,626) |
Cash and cash equivalents, beginning of period | 3,596,262 | 10,460,117 |
Cash and cash equivalents, end of period | 1,893,414 | 5,940,491 |
Supplemental cash flow disclosures: | ||
Cash paid for interest | $ 78,381 |
NATURE OF BUSINESS
NATURE OF BUSINESS | 9 Months Ended |
Sep. 30, 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 the 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 Company’s common stock held by such stockholder (which were cancelled and resumed the status of authorized but unissued shares of the Company’s common stock) and (ii) certain representations, covenants and indemnities. As a result of the Merger and the 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 Company’s common stock and a warrant to purchase one share of the Company’s 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 Enumeral’s 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 Company’s 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 pursuing a pipeline focused on next-generation checkpoint modulators, with initial targets including TIM-3, LAG-3, CD39, TIGIT, and VISTA. The Company’s 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 Company’s 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 | 9 Months Ended |
Sep. 30, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
GOING CONCERN AND LIQUIDITY | 2 - GOING CONCERN AND LIQUIDITY The Company’s unaudited condensed consolidated financial statements have been prepared in conformity with generally accepted accounting principles in the United States of America (“GAAP”) which contemplate the Company’s continuation as a going concern. As of September 30, 2016, the Company had a working capital deficit of $2,348,364 including $905,666 of derivative liabilities and an accumulated deficit of $18,572,435. 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. On July 29, 2016 the Company entered into a Subscription Agreement (the “Subscription Agreement”) with certain accredited investors, pursuant to which these investors purchased the Company’s 12% Senior Secured Promissory Notes (the “Notes”) in the aggregate principal amount of $3,038,256 (before deducting placement agent fees and expenses of $385,337), which includes $38,256 pursuant to an over-allotment option (the “Note Offering”). The Company also incurred additional legal fees of $122,512 associated with the Notes. The Company is using the net proceeds from this Note Offering for working capital and general corporate purposes. Additional information concerning the Note Offering is presented below in Note 7, “Debt”. As of the date of this filing, the Company believes it has sufficient liquidity to fund operations into December 2016. The Company has commenced an issuer tender offer, as further described below, and is continuing to explore 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 Company’s net losses may fluctuate significantly from quarter to quarter and from year to year. These factors raise substantial doubt about the Company’s ability to continue as a going concern. On October 28, 2016, the Company commenced an issuer tender offer with respect to certain warrants to purchase common stock of the Company in order to provide the holders thereof with the opportunity to amend and exercise their warrants upon the terms and subject to the conditions set forth in the Company’s tender offer statement on Schedule TO and the related exhibits included therein (the “Offering Materials”). See Note 13 “Subsequent Events” for further details. The Company’s 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 December 2016. The Company’s near-term capital needs depend on many factors, including: • the Company’s ability to carefully manage its costs; • the amount and timing of revenue received from grants or the Company’s collaboration and license arrangements; and • the Company’s ability to raise additional capital through public or private equity offerings, debt financings, or strategic collaborations and licensing arrangements, and/or the Company’s success in promptly establishing a strategic alternative that is in its stockholders’ best interests. If the Company is unable to raise additional capital through one or more of the means listed above prior to the end of December 2016, the Company could face substantial liquidity problems and might be required to implement further cost reduction strategies in addition to the cash conservation steps that the Company has already taken. These reductions could significantly affect the Company’s research and development activities, and could result in significant harm to the Company’s 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 Company’s 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 Company’s common stock. The issuance of these securities could also result in significant dilution to some or all of the Company’s stockholders, depending on the terms of the transaction. For example, the PPO Warrants contain anti-dilution protection in the event that the Company issues common stock or securities convertible into or exercisable for shares of the Company’s common stock at a price lower than the warrant exercise price prior to the warrant expiration date. 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 Company’s 2014 Equity Incentive Plan, and (c) other exempt issuances. In the event that the Company is able to successfully complete the tender offer to amend and exercise the PPO Warrants that the Company launched in October 2016 (described in greater detail in Note 13 below), the PPO Warrants would be amended to remove this anti-dilution provision with the consent of holders of a majority of the underlying PPO Warrants. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended |
Sep. 30, 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 GAAP 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 GAAP 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 Securities Exchange Commission (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 September 30, 2016 and the results of its operations and cash flows for the nine months ended September 30, 2016 and 2015. Such adjustments are of a normal recurring nature. The results of operations for the three and nine months ended September 30, 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 Company’s 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 Company’s assets and liabilities that are measured at fair value on a recurring basis are measured in accordance with the Financial Accounting Standards Board’s (“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 Company’s cash equivalents, carried at fair value, are comprised of investments in federal agency backed money market funds. The valuation of the Company’s derivative liabilities is discussed below and in Note 11. The following table presents information about the Company’s financial assets and liabilities measured at fair value on a recurring basis as of September 30, 2016 and December 31, 2015: September 30, 2016 Quoted Prices in Active Markets (Level 1) Observable Inputs (Level 2) Unobservable Inputs (Level 3) Assets Cash $ 611,201 $ 611,201 $ - $ - Money Market funds, included in cash equivalents $ 1,282,213 $ 1,282,213 $ - $ - Liabilities Derivative liabilities $ 905,666 $ - $ - $ 905,666 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 Company’s derivative liabilities, using Level 3 inputs: Balance as of December 31, 2015 $ 2,138,091 Change in fair value (1,232,425 ) Balance as of September 30, 2016 $ 905,666 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 September 30, 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 and nine months ended September 30, 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 value 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 Company’s 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 Company’s antibody discovery and immune profiling platform and MDACC’s 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 “Original License Agreement”) with Pieris Pharmaceuticals, Inc. and Pieris Pharmaceuticals GmbH (collectively, “Pieris”). Pursuant to the terms and conditions of the Original License Agreement, Pieris is licensing from the Company specified intellectual property related to the Company’s 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 Original License Agreement, Pieris paid the Company a $250,000 initial license fee. In June 2016, the Company entered into a Definitive License and Transfer Agreement (the “Definitive Agreement”) with Pieris, and as contemplated in the Original License Agreement, Pieris paid the Company a $750,000 license maintenance fee to continue the licensing arrangements under the Original License Agreement. In accordance with its terms, the Definitive Agreement superseded the Original License Agreement. Under the Definitive Agreement, the Company has granted Pieris an option until May 31, 2017 to license specified patent rights and know-how of the Company covering two additional undisclosed antibody programs on the same terms and conditions as for the Company’s 388D4 anti-PD-1 antibody (each, a “Subsequent Option”). Pieris may exercise the Subsequent Options separately and on different dates during the option period. Pieris will pay the Company additional license fees in the event that Pieris exercises one or both Subsequent Options. The Company recognized $226,115 and $395,448 of collaboration and license revenue for the three months ended September 30, 2016 and 2015, respectively. The Company recognized $1,878,599 and $894,132 of collaboration and license revenue for the nine months ended September 30, 2016 and 2015, respectively. Grant Revenue In September 2014, the Company was awarded a Phase II Small Business Innovation Research contract from the National Cancer Institute (“NCI”), a unit of the National Institutes of Health, for up to $999,967 over two years. In September 2016, the Company signed an amendment with the NCI to extend the contract an additional six months. 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 $94,696 and $88,377 of revenue associated with the NCI Phase II grant for the three months ended September 30, 2016 and 2015, respectively. The Company recognized $375,641 and $245,728 of revenue associated with the NCI Phase II grant for the nine months ended September 30, 2016 and 2015, respectively. The difference between the total consideration received to date and the revenue recognized is recorded as deferred revenue. Deferred revenue totaled $29,009 as of September 30, 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 Company’s core technology, are expensed as research and development expense. Derivative Liabilities The Company’s derivative liabilities relate to (a) warrants to purchase an aggregate of 23,549,509 shares of the Company’s common stock that were issued in connection with the PPO 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 Enumeral’s debt financing arrangement with Square 1 Bank that were subsequently converted into warrants to purchase 66,574 shares of the Company’s common stock in connection with the Merger in July 2014. Additional detail regarding these warrants can be found in Note 11. 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 Company’s 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) was 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 and nine months ended September 30, 2016. The Company recognized no reclassifications out of accumulated other comprehensive loss or unrealized holding losses on available-for-sale securities for the three months ended September 30, 2015. The Company reclassified $19,097 out of accumulated other comprehensive loss to net income and recognized $9,320 of unrealized holding losses on available-for-sale securities for the nine months ended September 30, 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 Company’s 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 Company’s 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 Company’s common stock on the date of grant. Expense is recognized over the vesting period. The Company has recorded stock-based compensation expense of $280,976 and $184,775 for the three months ended September 30, 2016 and 2015, respectively. The Company has recorded stock-based compensation expense of $883,298 and $477,666 for the nine months ended September 30, 2016 and 2015, respectively. The Company has an aggregate of $272,771 of unrecognized stock-based compensation expense as of September 30, 2016 to be amortized over a weighted average period of 1.9 years. Effective January 1, 2016, the Company has elected to account for forfeitures as they occur, as permitted by Accounting Standards Update (“ASU”) ASU No. 2016-09, Compensation-Stock Compensation (Topic 718), Improvements to Employee Share-Based Payment Accounting Prior to the adoption of ASU No. 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 September 30, 2016 and 2015, the number of shares underlying options and warrants that were anti-dilutive were approximately 33.6 million and 25.9 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 September 30, 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 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 No. 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 No. 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 employer’s minimum statutory withholding requirements and classification in the statement of cash flows did not have any impact on the Company’s financial position, results of operations or cash flows. In April 2015, the FASB issued ASU No. 2015-03, Interest – Imputation of Interest (Subtopic 305-40): Simplifying the Presentation of Debt Issuance Costs 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 Company’s unaudited condensed consolidated financial statements upon adoption. |
PROPERTY AND EQUIPMENT, NET
PROPERTY AND EQUIPMENT, NET | 9 Months Ended |
Sep. 30, 2016 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY AND EQUIPMENT, NET | 4 - PROPERTY AND EQUIPMENT, NET Property and equipment, net consist of the following: September 30, 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 (1,865,127 ) (1,384,826 ) $ 1,031,192 $ 1,511,493 Depreciation and amortization expense for the three and nine months ended September 30, 2016 was $126,301 and $480,301, respectively. Depreciation and amortization expense for the three and nine months ended September 30, 2015 was $149,901 and $425,788, respectively. During the nine months ended September 30, 2015, the Company expensed $22,962 associated with the write-down of leasehold improvements due to a relocation of the Company’s corporate office and research laboratories in March 2015 (see Note 8). |
RESTRICTED CASH
RESTRICTED CASH | 9 Months Ended |
Sep. 30, 2016 | |
Cash and Cash Equivalents [Abstract] | |
RESTRICTED CASH | 5 - RESTRICTED CASH The Company held $534,780 in restricted cash as of September 30, 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 Company’s facility lessor in accordance with the Company’s facility lease agreement. |
ACCRUED EXPENSES
ACCRUED EXPENSES | 9 Months Ended |
Sep. 30, 2016 | |
Payables and Accruals [Abstract] | |
ACCRUED EXPENSES | 6 - ACCRUED EXPENSES The Company’s accrued expenses consist of the following as of: September 30, December 31, 2016 2015 Accrued wages and benefits $ 287,662 $ 447,769 Accrued professional fees 154,887 213,475 Accrued other 42,900 53,140 Total accrued expenses $ 485,449 $ 714,384 |
DEBT
DEBT | 9 Months Ended |
Sep. 30, 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”). Fountain’s 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 $248,794 and long-term equipment lease financing of $78,822 as of September 30, 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 Company’s unaudited condensed consolidated balance sheets. Future payments on the equipment lease financing are as follows: For the twelve months ended September 30, Amount 2017 $ 258,541 2018 76,042 2019 3,802 Total equipment lease financing payments $ 338,385 As of September 30, 2016 Amount Current equipment lease financing payments $ 258,541 Less: Amount representing interest (9,747 ) Current equipment lease financing, net $ 248,794 Long-term equipment lease financing payments $ 79,844 Less: Amount representing interest (1,022 ) Long-term equipment lease financing, net $ 78,822 Promissory Notes On July 29, 2016 (the “Closing Date”), the Company entered into a Subscription Agreement (the “Subscription Agreement”) with certain accredited investors (the “Buyers”), pursuant to which the Buyers purchased the Company’s 12% Senior Secured Promissory Notes (the “Notes”) in the aggregate principal amount of $3,038,256 (before deducting placement agent fees and expenses of $385,337), which includes $38,256 pursuant to an over-allotment option (the “Note Offering”). The Company incurred additional legal fees of $122,512 associated with the Notes. The Company is using the net proceeds from this Note Offering for working capital and general corporate purposes. The Notes have an aggregate principal balance of $3,038,256, and a stated maturity date of 12 months from the date of issuance. The principal on the Notes bears interest at a rate of 12% per annum, payable monthly commencing on September 1, 2016. Interest is payable in shares (the “Repayment Shares”) of the Company’s common stock; provided, however, that interest will not be calculated or accrued in a manner that triggers anti-dilution adjustment on the PPO Warrants. In the event that on an interest payment date, the PPO Warrants’ anti-dilution provision would be triggered by the payment of interest in shares of the Company’s common stock, interest payments on the Notes may be paid in cash. The Notes will rank senior to all existing indebtedness of the Company, except as otherwise set forth in the Notes. The maturity date of the outstanding principal amount of the Notes, together with accrued and unpaid interest due thereon, will accelerate to the date (on or after September 1, 2016) on which the Company completes and closes certain financing transactions that achieve minimum thresholds, as specified in the Notes. In such specified transactions, the Notes will convert at a valuation per share equal to 50% of the price per share of securities sold in that financing transaction. In addition, in the event of a sale of the Company during the term of the Notes, noteholders will be entitled to receive 1.5x of the principal amount of the Notes plus accrued interest, paid in either cash or securities of acquiring entity at the acquiring entity’s discretion. The Company’s obligations under the Notes are secured, pursuant to the terms of an Intellectual Property Security Agreement (the “Security Agreement”), dated as of the Closing Date, among the Company, Enumeral, the Buyers and the collateral agent for the Buyers named therein, by a first priority security interest in all now owned or hereafter acquired intellectual property of the Company and Enumeral, except to the extent such intellectual property cannot be assigned or the creation of a security interest would be prohibited by applicable law or contract. As part of the issuance of the Notes, the Company incurred $507,849 of transaction costs, which are recorded as a reduction of the promissory notes on the unaudited condensed consolidated balance sheet as of September 30, 2016. These transaction costs are being accreted to interest expense over the term of the Notes. Interest expense associated with these transaction costs of $84,642 was accreted during the three months ended September 30, 2016. As of September 30, 2016 the remaining transaction costs of $423,207 were recorded as a reduction to the promissory notes on the unaudited condensed consolidated balance sheet. |
COMMITMENTS
COMMITMENTS | 9 Months Ended |
Sep. 30, 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 Lease in the amount of $57,446 and $36,847 as of September 30, 2016 and December 31, 2015, respectively. 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 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 Enumeral’s 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 Company’s New York office expires on December 31, 2016, and the Company does not contemplate renewing such lease. Rent expense was $282,423 and $278,652 for the three months ended September 30, 2016 and 2015, respectively. Rent expense was $929,243 and $730,140 for the nine months ended September 30, 2016 and 2015, respectively. Future operating lease commitments as of September 30, 2016 are as follows: For the twelve months ended September 30, Amount 2017 $ 755,231 2018 771,889 2019 794,995 2020 335,308 Total $ 2,657,423 Employment Agreements The Company has employment letter agreements with members of management which contain minimum annual salaries and severance benefits if terminated prior to the term of the agreements. In conjunction with the closing of the Note Offering, Arthur H. Tinkelenberg, Ph.D. was terminated by the Company from his position as President and Chief Executive Officer, effective July 28, 2016. During the nine months ended September 30, 2016, the Company recorded charges related to severance and benefits owed to Dr. Tinkelenberg as a result of his termination. Dr. Tinkelenberg resigned as a director of the Company on September 19, 2016. On September 21, 2016, John J. Rydzewski resigned as Executive Chairman of the Company, and also resigned from the Board of Directors. In connection with Mr. Rydzewski’s resignation, the Company entered into a separation letter agreement with Mr. Rydzewski, dated September 21, 2016. As part of Mr. Rydzewski’s separation letter agreement, 703,326 options became fully vested and the Company incurred a one-time stock-based compensation charge of $83,361 during the three months ended September 30, 2016. In addition, the terms of Mr. Rydzewski’s separation letter agreement provide that the Company will continue to pay 100% of the cost of Mr. Rydzewski’s continuation of health and dental benefits through COBRA, until the earlier of 18 months from Mr. Rydzewski’s separation date from the Company or such time as Mr. Rydzewski becomes eligible for similar benefits from another employer. The Company appointed Wael Fayad to serve as President and Chief Executive Officer of the Company, effective as of September 21, 2016, and, in connection therewith, appointed Mr. Fayad as a director of the Company and Chairman of the Board of Directors. In connection with Mr. Fayad’s appointment, the Board of Directors designated Mr. Fayad as the Company’s “Principal Executive Officer” for U.S. Securities and Exchange Commission reporting purposes, effective as of September 21, 2016. In addition, the Company entered into an offer letter with Mr. Fayad, dated September 21, 2016 (the “Letter Agreement”), which sets forth the terms pursuant to which Mr. Fayad shall serve as the Company’s Chairman of the Board, President and Chief Executive Officer. The Letter Agreement provides that Mr. Fayad will receive a base salary at the rate of $325,000 per annum. Mr. Fayad will also be eligible to earn a target bonus of up to 50% of the base salary, payable in cash, based upon achievement of corporate objectives, individual objectives, and the Company’s finances, all as determined and at the discretion of the independent members of the Board or the Board’s Compensation Committee. Mr. Fayad was granted 2,600,000 options to purchase shares of the Company’s common stock in connection with the offer letter. The Company granted Mr. Fayad 850,000 options under the Company’s 2014 Equity Incentive Plan (the “2014 Plan”) and 1,750,000 options outside of the 2014 Plan. Of these, 100,000 options vested immediately upon grant, and the remaining 2,500,000 options vest upon achievement of certain performance-based milestones. |
LICENSE AGREEMENT AND RELATED-P
LICENSE AGREEMENT AND RELATED-PARTY TRANSACTIONS | 9 Months Ended |
Sep. 30, 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 MIT, then a related party (as one of Enumeral’s 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 September 30, 2016 and 2015, respectively. The Company incurred $30,000 and $22,500 in the nine months ended September 30, 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 paid an annual fee of $40,000 in 2016, and is obligated to pay $50,000 every year thereafter unless the License Agreement is terminated. During the nine months ended September 30, 2016, the Company recorded expense of $100,000 for the required percentage of the Pieris license payments owed to MIT 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 September 30, 2016 and 2015, Enumeral paid $23,052 and $15,646 for MIT and $2,351 and $3,730 for Harvard, respectively. For the nine months ended September 30, 2016 and 2015, Enumeral paid $162,692 and $256,189 for MIT and $17,692 and $22,367 for Harvard, respectively. The Company had accounts payable and accrued expenses of $38,346 and $168,726 associated with the reimbursement of costs and fees owed to MIT and Harvard as of September 30, 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 MIT’s participation rights and anti-dilution rights under the License Agreement were terminated. Other than the exchange of Enumeral’s common stock for the Company’s 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 License Agreement). Consulting Agreements In September 2014, the Company and Dr. Barry Buckland entered into a Scientific Advisory Board Agreement (the “SAB Agreement”), which replaced Dr. Buckland’s previous consulting agreement and pursuant to which Dr. Buckland serves as chairman of the Company’s Scientific Advisory Board. The SAB Agreement had 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. Buckland’s election, in options to purchase the Company’s common stock. The SAB Agreement limits the total amount of compensation payable to Dr. Buckland at $100,000 over any rolling 12-month period. In September 2016, the Company and Dr. Buckland entered into an amendment to the SAB Agreement to extend the term of the agreement an additional year. During the three months ended September 30, 2016 and 2015, the Company recognized $4,000 and $4,000 of expense related to the SAB Agreement, respectively. During the nine months ended September 30, 2016 and 2015, the Company recognized $8,000 and $27,000 of expense related to the SAB Agreement, respectively. |
EQUITY
EQUITY | 9 Months Ended |
Sep. 30, 2016 | |
Stockholders' Equity Note [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 Enumeral’s 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 Enumeral’s 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 309,966 shares of the Company’s common stock (see Merger discussion below). Merger On July 31, 2014, Enumeral entered into the Merger Agreement, pursuant to which Enumeral became a wholly owned subsidiary of the Company. The Company’s 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. 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 Enumeral’s common stock issued and outstanding immediately prior to the closing of the Merger was converted into 1.102121 shares of the Company’s common stock for a total of 4,940,744 shares post-Merger, (b) each share of Enumeral’s Series A Preferred Stock issued and outstanding immediately prior to the closing of the Merger was converted into 1.598075 shares of the Company’s common stock for a total of 4,421,744 shares post-Merger, (c) each share of Enumeral’s Series A-1 Preferred Stock issued and outstanding immediately prior to the closing of the Merger was converted into 1.790947 shares of the Company’s common stock for a total of 3,666,428 shares post-Merger, (d) each share of Enumeral’s Series A-2 Preferred Stock issued and outstanding immediately prior to the closing of the Merger was converted into 1.997594 shares of the Company’s common stock for a total of 3,663,177 shares post-Merger, (e) each share of Enumeral’s Series B Preferred Stock issued and outstanding immediately prior to the closing of the Merger was converted into 2.927509 shares of the Company’s 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 Company’s common stock post-Merger. All warrants are converted using the same exchange ratio as the common and preferred shares. As a result of the Merger and the 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 have been replaced with the historical financial statements of Enumeral prior to the Merger in all filings with the SEC. Private Placement On July 31, 2014, the Company closed 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 Company’s common stock and a warrant to purchase one share of the Company’s 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 Company’s 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 Company’s 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 Company’s 2014 Equity Incentive Plan, and (c) other exempt issuances. In the event that the Company is able to successfully complete the tender offer to amend and exercise PPO Warrants that the Company launched in October 2016 (described in greater detail in Note 13 below), the PPO Warrants would be amended to remove this anti-dilution provision with the consent of holders of a majority of the underlying PPO Warrants. 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 Company’s 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 Company’s 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 Company’s 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 Company’s common stock. In addition, the Merger Agreement provided 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), 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 Company’s common stock to holders of the Company’s 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 | 9 Months Ended |
Sep. 30, 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 On July 31, 2014, the Company’s Board of Directors adopted, and the Company’s stockholders approved, the 2014 Equity Incentive Plan (the “2014 Plan”), which reserves a total of 8,100,000 shares of the Company’s 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 Company’s 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. The Company recognizes all share-based awards under the straight-line attribution method, assuming that all granted awards will vest. Effective January 1, 2016, 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 Company’s 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. The weighted-average fair value of options granted during the nine month period ended September 30, 2016 was $0.16. Nine Months Ended Expected volatility 116.0% - 117.0% Risk-free interest rate 1.20% - 1.72% Expected term (in years) 5.00 Expected dividend yield 0% As of September 30, 2016, there were 187,481 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 Company’s capitalization. A summary of stock option activity for the nine months ended September 30, 2016 is as follows: Weighted- Weighted- Average Average Remaining Exercise Contractual Shares Price Term (years) Outstanding as of December 31, 2015 5,926,654 $ 0.62 9.0 Granted 4,068,182 $ 0.20 Exercised - $ - Canceled (1,247,476 ) $ 0.72 Outstanding as of September 30, 2016 8,747,360 $ 0.41 8.9 Exercisable as of September 30, 2016 4,910,317 $ 0.46 8.5 Stock option compensation expense was $260,343 and $167,575 for the three months ended September 30, 2016 and 2015, respectively. Stock option compensation expense was $803,747 and $418,641 for the nine months ended September 30, 2016 and 2015, respectively. The Company has an aggregate of $272,771 of unrecognized stock option compensation expense as of September 30, 2016 to be amortized over a weighted-average period of 1.9 years. In September 2016, Dr. Tinkelenberg resigned as a director of the Company. As a result of his resignation, the Company incurred a one-time stock-based compensation charge of $15,580 during the three months ended September 30, 2016 for the remaining shares the Company expects to vest. In September 2016, Mr. Rydzewski resigned as Executive Chairman and director of the Company. In connection with his resignation, all of Mr. Rydzewski’s unvested options became fully vested. As a result, 703,326 options became fully vested and the Company incurred a one-time stock-based compensation charge of $83,361 during the three months ended September 30, 2016. In September 2016, the Company entered into an offer letter with Mr. Fayad, (the “Letter Agreement”) which sets forth the terms pursuant to which Mr. Fayad shall serve as the Company’s Chairman of the Board, President and Chief Executive Officer. Per the Letter Agreement Mr. Fayad was granted 2,600,000 options to purchase shares of the Company’s common stock. The Company granted Mr. Fayad 850,000 options under the 2014 Plan and 1,750,000 options outside of the 2014 Plan. These options vest and become exercisable as follows: (i) 100,000 options vested immediately upon grant and (ii) 2,500,000 options vest upon the achievement of certain performance-based milestones. The aggregate intrinsic value of options exercisable as of September 30, 2016 was $4,712. 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 nine months ended September 30, 2016 is as follows: Weighted- Number of Average Grant Shares Date Fair Value Balance of unvested restricted stock as of December 31, 2015 282,119 $ 0.24 Issuance of restricted stock 140,910 $ 0.22 Vested (380,362 ) $ 0.23 Balance of unvested restricted stock as of September 30, 2016 42,667 $ 0.22 Restricted stock compensation expense was $20,633 and $17,200 for the three months ended September 30, 2016 and 2015, respectively. Restricted stock compensation expense was $79,551 and $59,025 for the nine months ended September 30, 2016 and 2015, respectively. The Company had no unrecognized restricted stock compensation expense as of September 30, 2016. Warrants As of September 30, 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 Company’s common stock. Additionally, in connection with Enumeral’s December 2011 financing transaction with Square 1 Bank, Enumeral issued warrants to purchase 41,659 shares of Enumeral’s Series A preferred stock that were subsequently converted into warrants to purchase 66,574 shares of the Company’s 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 Company’s common stock in connection with the PPO, of which warrants to purchase 21,549,510 shares of the Company’s 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 Company’s 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 5.0 years, 105.4% volatility, a risk-free rate of 1.77%, and no expected dividends. The estimated fair value of the warrants at September 30, 2016 was determined to be $901,368 using the Black-Scholes pricing model and the following assumptions: expected remaining term of 2.83 years, 106.4% volatility, risk-free rate of 0.86%, 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 sheets. 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 September 30, 2016 and December 31, 2015, respectively. If the Company successfully eliminates the anti-dilution protection for these warrants as part of the October 28, 2016 tender offer, the Company will no longer account for these warrants as derivative liabilities. See Note 13 “Subsequent Events” for further details. 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 Company’s common stock at an exercise price of $0.73 per share. The estimated fair value of the warrants as of September 30, 2016 was determined to be $3,358 using the Black-Scholes pricing model and the following assumptions: expected term of 2.18 years, 106.4% volatility, a risk-free rate of 0.79%, and no expected dividends. 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, a risk-free rate of 1.31%, and no expected dividends. 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 Company’s common stock at an exercise price of $0.73 per share. The estimated fair value of these warrants as of September 30, 2016 was determined to be $940 using the Black-Scholes pricing model and the following assumptions: expected term of 2.7 years, 106.4% volatility, a risk-free rate of 0.85%, and no expected dividends. 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, a risk-free rate of 1.42%, and no expected dividends. 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 September 30, 2016 and December 31, 2015 these warrants were outstanding and expire on December 5, 2018 and June 12, 2019, respectively. |
CONCENTRATIONS
CONCENTRATIONS | 9 Months Ended |
Sep. 30, 2016 | |
Risks and Uncertainties [Abstract] | |
CONCENTRATIONS | 12 - CONCENTRATIONS During the three months ended September 30, 2016, the Company recorded revenue from two entities in excess of 10% of the Company’s total revenue in the amounts of $226,115 and $94,696, which represents 70% and 30% of the Company’s total revenue for that period. During the three months ended September 30, 2015, the Company recorded revenue from two entities in excess of 10% of the Company’s total revenue in the amounts of $395,448 and $88,377, which represents 82% and 18% of the Company’s total revenue for that period. During the nine months ended September 30, 2016, the Company recorded revenue from three entities in excess of 10% of the Company’s total revenue in the amounts of $1,000,000, $878,599 and $375,641 which represents 44%, 39% and 17% of the Company’s total revenue for that period. During the nine months ended September 30, 2015, the Company recorded revenue from two entities in excess of 10% of the Company’s total revenue in the amounts of $894,132 and $245,728, which represents 78% and 22% of the Company’s total revenue for that period. As of September 30, 2016, accounts receivable consisted of amounts due from two entities which represented 85% and 15% of the Company’s 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 Company’s total outstanding accounts receivable balance, respectively. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 9 Months Ended |
Sep. 30, 2016 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | 13 - SUBSEQUENT EVENTS On October 28, 2016, the Company commenced an issuer tender offer with respect to certain warrants to purchase common stock of the Company in order to provide the holders thereof with the opportunity to amend and exercise their warrants upon the terms and subject to the conditions set forth in the Company’s tender offer statement on Schedule TO and the related exhibits included therein (the “Offering Materials”). The Company is offering to amend, upon the terms and subject to the conditions set forth in the Offering Materials (the “Offer to Amend and Exercise”), its outstanding warrants to purchase 21,549,510 shares of the Company’s common stock at an exercise price of $2.00 per share (the “Original Warrants”), issued to investors who participated in the PPO. Pursuant to the Offer to Amend and Exercise, the Original Warrants of holders who elect to participate in the Offer to Amend and Exercise will be amended (the “Amended Warrants”) to: (i) receive four shares of common stock for each warrant exercised rather than one; (ii) reduce the exercise price to $0.50 per warrant in cash (or $0.125 per share based on the 4 common shares that they will receive upon exercise); (iii) shorten the exercise period so that it expires concurrently with the expiration of the Offer to Amend and Exercise at 5:00 p.m. (Eastern Time) on November 29, 2016, as such expiration date may be extended by the Company in its sole discretion, or as required by applicable law (the “Expiration Date”); (iv) delete any price-based anti-dilution provisions; (v) restrict the ability of the holder of shares issuable upon exercise of the Amended Warrants to sell, make any short sale of, loan, grant any option for the purchase of, or otherwise dispose of any of such shares without the prior written consent of the Company for a period of one hundred eighty (180) days after the Expiration Date (the “Lock-Up Period”); and (vi) provide that a holder, acting alone or with others, will agree not to effect any purchases or sales of any securities of the Company in any “short sales” as defined in Rule 200 promulgated under Regulation SHO under the Exchange Act, or any type of direct and indirect stock pledges, forward sale contracts, options, puts, calls, short sales, swaps, “put equivalent positions” (as defined in Rule 16a-1(h) under the Exchange Act) or similar arrangements, or sales or other transactions through non-U.S. broker dealers or foreign regulated brokers through the expiration of the Lock-Up Period. The Company plans to use the net proceeds from the Offer to Amend and Exercise to fund its ongoing operations and for general working capital purposes. Holders may elect to participate in the Offer to Amend and Exercise with respect to some, all or none of their Original Warrants. If holders choose not to participate in the Offer to Amend and Exercise, their Original Warrants will remain in full force and effect, as originally issued with an exercise price of $2.00 per share. However, regardless of whether a holder participates in the Offer to Amend and Exercise, such holder may nevertheless consent to the amendment to the Original Warrants to remove the price-based anti-dilution provisions contained in the outstanding Original Warrants (the “Anti-Dilution Amendment”). In addition, the Company has agreed to enter into a Registration Rights Agreement pursuant to which the Company will file a Registration Statement on Form S-1 to register the resale of the shares of Common Stock issued upon exercise of the Amended Warrants and upon the conversion of the Notes, as well as shares underlying warrants issued to the placement agent in connection with the conversion of the Notes. Subject to the joint waiver of the Company and the warrant agent for this Offer to Amend and Exercise, the Offer to Amend and Exercise will not be completed unless the following conditions are satisfied: (i) a minimum of $2,000,000 in gross proceeds is received and (ii) holders of a majority of the Original Warrants agree to the Anti-Dilution Amendment (the “Majority Holders’ Consent”). If the Company receives the Majority Holders’ Consent to the Anti-Dilution Amendment, all of the Original Warrants will be amended such that the price based anti-dilution provision of the Original Warrants will no longer apply without regard to whether such holder provided consent. In addition to the Original Warrants, there are outstanding warrants to purchase an aggregate of 2,000,000 shares of the Company’s common stock comprised of warrants issued to the placement agent and its sub-agents in the Company’s PPO Unit Offering (the “PPO Agent Warrants”). The PPO Agent Warrants contain the same type of price-based weighted-average anti-dilution provisions as the Original Warrants. Like the Original Warrants, the terms of each of the PPO Agent Warrants may be amended with the consent of the Company and the holders thereof. In connection with this Offer to Amend and Exercise, the Company is also seeking the consent of the holders of the PPO Agent Warrants in order to remove the price-based anti-dilution provisions from such warrants and, in consideration of (i) the majority of such holders granting such consent, and (ii) the Warrant Agent acting as such, to amend the PPO Agent Warrants to reduce the exercise price from $1.00 to $0.125 per share at the time of and in connection with the completion of the Offer to Amend and Exercise. |
SUMMARY OF SIGNIFICANT ACCOUN19
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 9 Months Ended |
Sep. 30, 2016 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated financial statements were prepared using GAAP 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 GAAP 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 Securities Exchange Commission (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 September 30, 2016 and the results of its operations and cash flows for the nine months ended September 30, 2016 and 2015. Such adjustments are of a normal recurring nature. The results of operations for the three and nine months ended September 30, 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 Company’s 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 Company’s assets and liabilities that are measured at fair value on a recurring basis are measured in accordance with the Financial Accounting Standards Board’s (“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 Company’s cash equivalents, carried at fair value, are comprised of investments in federal agency backed money market funds. The valuation of the Company’s derivative liabilities is discussed below and in Note 11. The following table presents information about the Company’s financial assets and liabilities measured at fair value on a recurring basis as of September 30, 2016 and December 31, 2015: September 30, Quoted Prices in Observable Unobservable Assets Cash $ 611,201 $ 611,201 $ - $ - Money Market funds, included in cash equivalents $ 1,282,213 $ 1,282,213 $ - $ - Liabilities Derivative liabilities $ 905,666 $ - $ - $ 905,666 December 31, Quoted Prices in Observable Unobservable 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 Company’s derivative liabilities, using Level 3 inputs: Balance as of December 31, 2015 $ 2,138,091 Change in fair value (1,232,425 ) Balance as of September 30, 2016 $ 905,666 |
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 September 30, 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 and nine months ended September 30, 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 value 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 Company’s 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 Company’s antibody discovery and immune profiling platform and MDACC’s 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 “Original License Agreement”) with Pieris Pharmaceuticals, Inc. and Pieris Pharmaceuticals GmbH (collectively, “Pieris”). Pursuant to the terms and conditions of the Original License Agreement, Pieris is licensing from the Company specified intellectual property related to the Company’s 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 Original License Agreement, Pieris paid the Company a $250,000 initial license fee. In June 2016, the Company entered into a Definitive License and Transfer Agreement (the “Definitive Agreement”) with Pieris, and as contemplated in the Original License Agreement, Pieris paid the Company a $750,000 license maintenance fee to continue the licensing arrangements under the Original License Agreement. In accordance with its terms, the Definitive Agreement superseded the Original License Agreement. Under the Definitive Agreement, the Company has granted Pieris an option until May 31, 2017 to license specified patent rights and know-how of the Company covering two additional undisclosed antibody programs on the same terms and conditions as for the Company’s 388D4 anti-PD-1 antibody (each, a “Subsequent Option”). Pieris may exercise the Subsequent Options separately and on different dates during the option period. Pieris will pay the Company additional license fees in the event that Pieris exercises one or both Subsequent Options. The Company recognized $226,115 and $395,448 of collaboration and license revenue for the three months ended September 30, 2016 and 2015, respectively. The Company recognized $1,878,599 and $894,132 of collaboration and license revenue for the nine months ended September 30, 2016 and 2015, respectively. |
Grant Revenue | Grant Revenue In September 2014, the Company was awarded a Phase II Small Business Innovation Research contract from the National Cancer Institute (“NCI”), a unit of the National Institutes of Health, for up to $999,967 over two years. In September 2016, the Company signed an amendment with the NCI to extend the contract an additional six months. 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 $94,696 and $88,377 of revenue associated with the NCI Phase II grant for the three months ended September 30, 2016 and 2015, respectively. The Company recognized $375,641 and $245,728 of revenue associated with the NCI Phase II grant for the nine months ended September 30, 2016 and 2015, respectively. The difference between the total consideration received to date and the revenue recognized is recorded as deferred revenue. Deferred revenue totaled $29,009 as of September 30, 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 Company’s core technology, are expensed as research and development expense. |
Derivative Liabilities | Derivative Liabilities The Company’s derivative liabilities relate to (a) warrants to purchase an aggregate of 23,549,509 shares of the Company’s common stock that were issued in connection with the PPO 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 Enumeral’s debt financing arrangement with Square 1 Bank that were subsequently converted into warrants to purchase 66,574 shares of the Company’s common stock in connection with the Merger in July 2014. Additional detail regarding these warrants can be found in Note 11. 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 Company’s 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) was 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 and nine months ended September 30, 2016. The Company recognized no reclassifications out of accumulated other comprehensive loss or unrealized holding losses on available-for-sale securities for the three months ended September 30, 2015. The Company reclassified $19,097 out of accumulated other comprehensive loss to net income and recognized $9,320 of unrealized holding losses on available-for-sale securities for the nine months ended September 30, 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 Company’s 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 Company’s 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 Company’s common stock on the date of grant. Expense is recognized over the vesting period. The Company has recorded stock-based compensation expense of $280,976 and $184,775 for the three months ended September 30, 2016 and 2015, respectively. The Company has recorded stock-based compensation expense of $883,298 and $477,666 for the nine months ended September 30, 2016 and 2015, respectively. The Company has an aggregate of $272,771 of unrecognized stock-based compensation expense as of September 30, 2016 to be amortized over a weighted average period of 1.9 years. Effective January 1, 2016, the Company has elected to account for forfeitures as they occur, as permitted by Accounting Standards Update (“ASU”) ASU No. 2016-09, Compensation-Stock Compensation (Topic 718), Improvements to Employee Share-Based Payment Accounting Prior to the adoption of ASU No. 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 September 30, 2016 and 2015, the number of shares underlying options and warrants that were anti-dilutive were approximately 33.6 million and 25.9 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 September 30, 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 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 No. 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 No. 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 employer’s minimum statutory withholding requirements and classification in the statement of cash flows did not have any impact on the Company’s financial position, results of operations or cash flows. In April 2015, the FASB issued ASU No. 2015-03, Interest – Imputation of Interest (Subtopic 305-40): Simplifying the Presentation of Debt Issuance Costs 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 Company’s unaudited condensed consolidated financial statements upon adoption. |
SUMMARY OF SIGNIFICANT ACCOUN20
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Accounting Policies [Abstract] | |
Schedule of financial assets and liabilities measured at fair value | The following table presents information about the Company’s financial assets and liabilities measured at fair value on a recurring basis as of September 30, 2016 and December 31, 2015: September 30, Quoted Prices in Observable Unobservable Assets Cash $ 611,201 $ 611,201 $ - $ - Money Market funds, included in cash equivalents $ 1,282,213 $ 1,282,213 $ - $ - Liabilities Derivative liabilities $ 905,666 $ - $ - $ 905,666 December 31, Quoted Prices in Observable Unobservable 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 fair value of derivative liabilities | The following table provides a roll forward of the fair value of the Company’s derivative liabilities, using Level 3 inputs: Balance as of December 31, 2015 $ 2,138,091 Change in fair value (1,232,425 ) Balance as of September 30, 2016 $ 905,666 |
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) | 9 Months Ended |
Sep. 30, 2016 | |
Property, Plant and Equipment [Abstract] | |
Schedule of property and equipment, net | Property and equipment, net consist of the following: September 30, 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 (1,865,127 ) (1,384,826 ) $ 1,031,192 $ 1,511,493 |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Payables and Accruals [Abstract] | |
Schedule of accrued expenses | The Company’s accrued expenses consist of the following as of: September 30, December 31, 2016 2015 Accrued wages and benefits $ 287,662 $ 447,769 Accrued professional fees 154,887 213,475 Accrued other 42,900 53,140 Total accrued expenses $ 485,449 $ 714,384 |
DEBT (Tables)
DEBT (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Debt Disclosure [Abstract] | |
Schedule of future principal payments | Future payments on the equipment lease financing are as follows: For the twelve months ended September 30, Amount 2017 $ 258,541 2018 76,042 2019 3,802 Total equipment lease financing payments $ 338,385 |
Schedule of equipment lease financing | As of September 30, 2016 Amount Current equipment lease financing payments $ 258,541 Less: Amount representing interest (9,747 ) Current equipment lease financing, net $ 248,794 Long-term equipment lease financing payments $ 79,844 Less: Amount representing interest (1,022 ) Long-term equipment lease financing, net $ 78,82 2 |
COMMITMENTS (Tables)
COMMITMENTS (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of future operating lease commitments | Future operating lease commitments as of September 30, 2016 are as follows: For the twelve months ended September 30, Amount 2017 $ 755,231 2018 771,889 2019 794,995 2020 335,308 Total $ 2,657,423 |
STOCK OPTIONS, RESTRICTED STO25
STOCK OPTIONS, RESTRICTED STOCK AND WARRANTS (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Schedule of valuation assumptions | 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. The weighted-average fair value of options granted during the nine month period ended September 30, 2016 was $0.16. Nine Months Ended Expected volatility 116.0% - 117.0% Risk-free interest rate 1.20% - 1.72% Expected term (in years) 5.00 Expected dividend yield 0% |
Schedule of stock option activity | A summary of stock option activity for the nine months ended September 30, 2016 is as follows: Weighted- Weighted- Average Average Remaining Exercise Contractual Shares Price Term (years) Outstanding as of December 31, 2015 5,926,654 $ 0.62 9.0 Granted 4,068,182 $ 0.20 Exercised - $ - Canceled (1,247,476 ) $ 0.72 Outstanding as of September 30, 2016 8,747,360 $ 0.41 8.9 Exercisable as of September 30, 2016 4,910,317 $ 0.46 8.5 |
Schedule of restricted stock activity | A summary of restricted stock activity for the nine months ended September 30, 2016 is as follows: Weighted- Number of Average Grant Shares Date Fair Value Balance of unvested restricted stock as of December 31, 2015 282,119 $ 0.24 Issuance of restricted stock 140,910 $ 0.22 Vested (380,362 ) $ 0.23 Balance of unvested restricted stock as of September 30, 2016 42,667 $ 0.22 |
NATURE OF BUSINESS (Details Nar
NATURE OF BUSINESS (Details Narrative) - $ / shares | Jul. 31, 2014 | Dec. 31, 2015 | Jul. 31, 2014 | Sep. 30, 2016 |
Private Placement Offering [Member] | ||||
Number of units issued | 21,549,510 | |||
Share price (in dollars per unit) | $ 1 | $ 1 | ||
Private Placement Offering [Member] | Common Stock [Member] | ||||
Number of shares consists in each unit | 1 | |||
Private Placement Offering [Member] | Warrant [Member] | ||||
Number of shares consists in each unit | 1 | 23,549,509 | ||
Warrant exercise price (in dollars per share) | $ 2 | $ 2 | ||
Warrant terms | 5 years | 3 years 6 months 29 days | 5 years | 2 years 9 months 29 days |
Split-Off Agreement [Member] | ||||
Number of shares surrender and cancellation | 23,100,000 |
GOING CONCERN AND LIQUIDITY (De
GOING CONCERN AND LIQUIDITY (Details Narrative) - USD ($) | Jul. 29, 2016 | Sep. 30, 2016 | Dec. 31, 2015 |
Working capital deficit | $ 2,348,364 | $ 615,530 | |
Derivative liabilities | 905,666 | 2,138,091 | |
Accumulated deficit | (18,572,435) | $ (14,408,976) | |
Legal fees | $ 122,512 | ||
Subscription Agreement [Member] | Accredited Investors [Member] | 12% Senior Secured Promissory Notes [Member] | |||
Debt face amount | $ 3,038,256 | ||
Placement agent fees and expenses | 385,337 | ||
Legal fees | 122,512 | ||
Subscription Agreement [Member] | Accredited Investors [Member] | 12% Senior Secured Promissory Notes [Member] | Over-Allotment Option [Member] | |||
Debt face amount | $ 38,256 |
SUMMARY OF SIGNIFICANT ACCOUN28
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - Recurring Basis [Member] - USD ($) | Sep. 30, 2016 | Dec. 31, 2015 |
Assets | ||
Cash | $ 611,201 | $ 815,890 |
Money Market funds, included in cash equivalents | 1,282,213 | 2,780,372 |
Liabilities | ||
Derivative liabilities | 905,666 | 2,138,091 |
Quoted Prices in Active Markets (Level 1) [Member] | ||
Assets | ||
Cash | 611,201 | 815,890 |
Money Market funds, included in cash equivalents | 1,282,213 | 2,780,372 |
Liabilities | ||
Derivative liabilities | ||
Observable Inputs (Level 2) [Member] | ||
Assets | ||
Cash | ||
Money Market funds, included in cash equivalents | ||
Liabilities | ||
Derivative liabilities | ||
Unobservable Inputs (Level 3) [Member] | ||
Assets | ||
Cash | ||
Money Market funds, included in cash equivalents | ||
Liabilities | ||
Derivative liabilities | $ 905,666 | $ 2,138,091 |
SUMMARY OF SIGNIFICANT ACCOUN29
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details 1) | 9 Months Ended |
Sep. 30, 2016USD ($) | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Balance at beginning | $ 2,138,091 |
Change in fair value | (1,232,425) |
Balance at ending | $ 905,666 |
SUMMARY OF SIGNIFICANT ACCOUN30
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details 2) | 9 Months Ended |
Sep. 30, 2016 | |
Laboratory Equipment [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Useful life | 3 years |
Laboratory Equipment [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Useful life | 5 years |
Computer/Office Equipment And Software [Member] | |
Property, Plant and Equipment [Line Items] | |
Useful life | 3 years |
Furniture, Fixtures and Office Equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Useful life | 3 years |
Leasehold Improvements [Member] | |
Property, Plant and Equipment [Line Items] | |
Description of useful life | Shorter of useful life or life of the lease |
SUMMARY OF SIGNIFICANT ACCOUN31
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($) | Jul. 29, 2016 | Jul. 31, 2014 | Sep. 30, 2016 | Jun. 30, 2016 | Apr. 30, 2016 | Sep. 30, 2014 | Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | Dec. 31, 2015 |
License revenue | $ 226,115 | $ 395,448 | $ 1,878,599 | $ 894,132 | |||||||
Grants revenue | 94,696 | 88,377 | 375,641 | 245,728 | |||||||
Deferred revenue | $ 29,009 | 29,009 | 29,009 | $ 130,539 | |||||||
Reclassification for loss included in net income | (19,097) | ||||||||||
Unrealized holding losses on available-for-sale securities | (9,320) | ||||||||||
Stock-based compensation expense | 280,976 | $ 184,775 | 883,298 | $ 477,666 | |||||||
Unrecognized stock-based compensation expense | $ 272,771 | $ 272,771 | $ 272,771 | ||||||||
Recognition period | 1 year 10 months 24 days | ||||||||||
Number of antidilutive shares | 33,600,000 | 25,900,000 | |||||||||
Pieris Pharmaceuticals, Inc. & Pieris Pharmaceuticals GmbH [Member] | Original License Agreement [Member] | |||||||||||
Initial license fee | $ 250,000 | ||||||||||
Pieris Pharmaceuticals, Inc. & Pieris Pharmaceuticals GmbH [Member] | Definitive Agreement [Member] | |||||||||||
License maintenance fee | $ 750,000 | ||||||||||
National Cancer Institute (Unit of the National Institutes of Health) [Member] | Phase II Small Business Innovation Research [Member] | |||||||||||
Grants revenue | $ 999,967 | ||||||||||
Grant revenue, period term | 6 months | 2 years | |||||||||
Accredited Investors [Member] | Subscription Agreement [Member] | 12% Senior Secured Promissory Notes [Member] | |||||||||||
Transaction costs | $ 507,849 | $ 423,207 | |||||||||
Warrant [Member] | Private Placement Offering [Member] | |||||||||||
Number of shares issued | 1 | 23,549,509 | |||||||||
Unrealized holding losses on available-for-sale securities | $ 9,320 | ||||||||||
Warrant [Member] | Series A Convertible Preferred Stock [Member] | |||||||||||
Number of shares issued | 41,659 | ||||||||||
Warrant [Member] | Square 1 Bank [Member] | |||||||||||
Number of shares issued | 66,574 |
PROPERTY AND EQUIPMENT, NET (De
PROPERTY AND EQUIPMENT, NET (Details) - USD ($) | Sep. 30, 2016 | Dec. 31, 2015 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 2,896,319 | $ 2,896,319 |
Less - Accumulated depreciation and amortization | (1,865,127) | (1,384,826) |
Property and equipment, net | 1,031,192 | 1,511,493 |
Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 2,559,986 | 2,559,986 |
Computer/Office Equipment And Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 187,337 | 187,337 |
Furniture, Fixtures and Office Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 73,734 | 73,734 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 75,262 | $ 75,262 |
PROPERTY AND EQUIPMENT, NET (33
PROPERTY AND EQUIPMENT, NET (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Property, Plant and Equipment [Line Items] | ||||
Depreciation and amortization expense | $ 126,301 | $ 149,901 | $ 480,301 | $ 425,788 |
Leasehold Improvements [Member] | ||||
Property, Plant and Equipment [Line Items] | ||||
Assets write-down | $ 22,962 |
RESTRICTED CASH (Details Narrat
RESTRICTED CASH (Details Narrative) - USD ($) | Sep. 30, 2016 | Dec. 31, 2015 |
Cash and Cash Equivalents [Abstract] | ||
Restricted cash | $ 534,780 | $ 534,780 |
ACCRUED EXPENSES (Details)
ACCRUED EXPENSES (Details) - USD ($) | Sep. 30, 2016 | Dec. 31, 2015 |
Payables and Accruals [Abstract] | ||
Accrued wages and benefits | $ 287,662 | $ 447,769 |
Accrued professional fees | 154,887 | 213,475 |
Accrued other | 42,900 | 53,140 |
Total accrued expenses | $ 485,449 | $ 714,384 |
DEBT (Details)
DEBT (Details) | Sep. 30, 2016USD ($) |
Debt Disclosure [Abstract] | |
2,017 | $ 258,541 |
2,018 | 76,042 |
2,019 | 3,802 |
Total equipment lease financing payments | $ 338,385 |
DEBT (Details 1)
DEBT (Details 1) - USD ($) | Sep. 30, 2016 | Dec. 31, 2015 |
Debt Disclosure [Abstract] | ||
Current equipment lease financing payments | $ 258,541 | |
Less: Amount representing interest | (9,747) | |
Current equipment lease financing, net | 248,794 | $ 240,473 |
Long-term equipment lease financing payments | 79,844 | |
Less: Amount representing interest | (1,022) | |
Long-term equipment lease financing, net | $ 78,822 | $ 266,471 |
DEBT (Details Narrative)
DEBT (Details Narrative) - USD ($) | 1 Months Ended | |
Dec. 31, 2015 | Sep. 30, 2016 | |
Current equipment lease financing, net | $ 240,473 | $ 248,794 |
Long-term equipment lease financing, net | 266,471 | $ 78,822 |
Master Lease Agreement [Member] | Fountain Leasing 2013 LP [Member] | Laboratory Equipment [Member] | ||
Lease amount | 506,944 | |
Security deposit | $ 101,389 | |
Lease term | 36 months | |
Description of lease | 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. | |
Extension of lease term | 12 months | |
Payments for extended lease, per month | $ 8,872 | |
Master Lease Agreement [Member] | Fountain Leasing 2013 LP [Member] | Laboratory Equipment [Member] | First 24 Months [Member] | ||
Payments for lease, per month | $ 21,545 | |
Lease rate factor | 4.25% | |
Master Lease Agreement [Member] | Fountain Leasing 2013 LP [Member] | Laboratory Equipment [Member] | 12 Months Thereafter [Member] | ||
Payments for lease, per month | $ 1,267 | |
Lease rate factor | 0.25% |
DEBT (Details Narrative 1)
DEBT (Details Narrative 1) - USD ($) | Jul. 29, 2016 | Sep. 30, 2016 | Sep. 30, 2016 |
Legal fees | $ 122,512 | ||
Subscription Agreement [Member] | Accredited Investors [Member] | 12% Senior Secured Promissory Notes [Member] | |||
Debt face amount | $ 3,038,256 | ||
Placement agent fees and expenses | $ 385,337 | ||
Description debt maturity | A stated maturity date of 12 months from the date of issuance. | ||
Legal fees | $ 122,512 | ||
Transaction costs | 507,849 | $ 423,207 | |
Interest expense | $ 84,642 | ||
Subscription Agreement [Member] | Accredited Investors [Member] | 12% Senior Secured Promissory Notes [Member] | Over-Allotment Option [Member] | |||
Debt face amount | $ 38,256 |
COMMITMENTS (Details)
COMMITMENTS (Details) | Sep. 30, 2016USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2,017 | $ 755,231 |
2,018 | 771,889 |
2,019 | 794,995 |
2,020 | 335,308 |
Total | $ 2,657,423 |
COMMITMENTS (Details Narrative)
COMMITMENTS (Details Narrative) | Sep. 21, 2016USD ($)shares | Jun. 30, 2015 | Mar. 31, 2015USD ($)ft² | Sep. 30, 2016USD ($) | Sep. 30, 2015USD ($) | Mar. 31, 2015USD ($)ft² | Sep. 30, 2016USD ($)shares | Sep. 30, 2015USD ($) | Dec. 31, 2015USD ($) |
Deferred rent | $ 57,446 | $ 57,446 | $ 36,847 | ||||||
Rent expense | 282,423 | $ 278,652 | $ 929,243 | $ 730,140 | |||||
Number of option granted | shares | 4,068,182 | ||||||||
MASSACHUSETTS (200 CambridgePark Drive) | Offices And Research Laboratories [Member] | |||||||||
Area of leasing facility | ft² | 16,825 | 16,825 | |||||||
Lease term | 5 years | ||||||||
Initial base rent on monthly basis, per square foot | 42.50 | ||||||||
Annual basis base rent | 715,062 | ||||||||
Security deposit | $ 529,699 | $ 529,699 | |||||||
Description of security deposit | 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. | ||||||||
Deferred rent | 57,446 | $ 57,446 | $ 36,847 | ||||||
MASSACHUSETTS (200 CambridgePark Drive) | Offices And Research Laboratories [Member] | Fifth Year Lease [Member] | |||||||||
Annual basis base rent | $ 804,739 | ||||||||
MASSACHUSETTS (One Kendall Square ) | Offices And Research Laboratories [Member] | |||||||||
Area of leasing facility | ft² | 4,782 | 4,782 | |||||||
Annual basis base rent | $ 248,664 | ||||||||
Exit cost | $ 55,352 | ||||||||
Lease expiration date | Jun. 17, 2015 | ||||||||
NEW YORK (1370 Broadway) | Corporate Office [Member] | |||||||||
Rent expense | $ 23,100 | ||||||||
Lease expiration date | Dec. 31, 2016 | ||||||||
2014 Equity Incentive Plan [Member] | |||||||||
Stock option compensation expense | 260,343 | $ 167,575 | $ 803,747 | $ 418,641 | |||||
Offer Letter Agreement [Member] | Mr. Wael Fayad [Member] | |||||||||
Number of shares vested | shares | 100,000 | ||||||||
Annual base salary | $ 325,000 | ||||||||
Description of bonus achievement objectives | Eligible to earn a target bonus of up to 50% of the base salary, payable in cash, based upon achievement of corporate objectives, individual objectives, and the Company’s finances, all as determined and at the discretion of the independent members of the Board or the Board’s Compensation Committee. | ||||||||
Number of option granted | shares | 2,600,000 | ||||||||
Number of shares vested for achievement of certain performance-based milestones | shares | 2,500,000 | ||||||||
Offer Letter Agreement [Member] | Outside 2014 Equity Incentive Plan [Member] | Mr. Wael Fayad [Member] | |||||||||
Number of option granted | shares | 1,750,000 | ||||||||
Offer Letter Agreement [Member] | 2014 Equity Incentive Plan [Member] | Mr. Wael Fayad [Member] | |||||||||
Number of option granted | shares | 850,000 | ||||||||
Separation Letter Agreement [Member] | 2014 Equity Incentive Plan [Member] | Mr. John J. Rydzewski [Member] | |||||||||
Stock option compensation expense | $ 83,361 | ||||||||
Number of shares vested | shares | 703,326 | ||||||||
Description of additional separation compensation | Company will continue to pay 100% of the cost of Mr. Rydzewski’s continuation of health and dental benefits through COBRA, until the earlier of 18 months from Mr. Rydzewski’s separation date from the Company or such time as Mr. Rydzewski becomes eligible for similar benefits from another employer. |
EQUITY (Details Narrative)
EQUITY (Details Narrative) | Jul. 31, 2014Number$ / sharesshares | Apr. 30, 2014USD ($)$ / sharesshares | Sep. 30, 2016$ / sharesshares | Dec. 31, 2015$ / sharesshares | Apr. 08, 2014shares |
Number of previously common shares authorized | 15,000,000 | ||||
Number of common shares authorized | 300,000,000 | 300,000,000 | 24,000,000 | ||
Common stock, par value | $ / shares | $ 0.001 | $ 0.001 | |||
Number of preferred stock authorized | 10,000,000 | 10,000,000 | |||
Preferred stock, par value | $ / shares | $ 0.001 | $ 0.001 | |||
Post-Merger [Member] | Enumeral Acquisition Corp [Member] | |||||
Conversion ratio | 1.102121 | ||||
Number of shares converted | 4,940,744 | ||||
Post-Merger [Member] | Enumeral Acquisition Corp [Member] | Convertible Debt [Member] | |||||
Number of shares issued on note conversion | Number | 3,230,869 | ||||
Merger Agreement [Member] | |||||
Number of common shares authorized | 300,000,000 | ||||
Common stock, par value | $ / shares | $ 0.001 | ||||
Number of preferred stock authorized | 10,000,000 | ||||
Preferred stock, par value | $ / shares | $ 0.001 | ||||
Placement Agent [Member] | |||||
Placement fee paid in cash | $ | $ 81,000 | ||||
Two Executive Officers [Member] | Warrant [Member] | |||||
Number of common shares issued | 309,966 | ||||
Series B Convertible Preferred Stock [Member] | |||||
Number of shares issued | 948,823 | ||||
Share price (in dollars per share) | $ / shares | $ 2.125 | ||||
Proceeds from issuance of shares | $ | $ 1,597,860 | ||||
Issuance costs | $ | $ 418,390 | ||||
Series B Convertible Preferred Stock [Member] | Post-Merger [Member] | Enumeral Acquisition Corp [Member] | |||||
Conversion ratio | 2.927509 | ||||
Number of shares converted | 2,777,687 | ||||
Series B Convertible Preferred Stock [Member] | Placement Agent [Member] | Warrant [Member] | |||||
Number of shares issued | 38,259 | ||||
Exercise price (in dollars per share) | $ / shares | $ 2.125 | ||||
Warrant terms | 5 years | ||||
Series B Convertible Preferred Stock [Member] | Two Executive Officers [Member] | Warrant [Member] | |||||
Number of shares issued | 105,881 | ||||
Series A Convertible Preferred Stock [Member] | Post-Merger [Member] | Enumeral Acquisition Corp [Member] | |||||
Conversion ratio | 1.598075 | ||||
Number of shares converted | 4,421,744 | ||||
Series A Convertible Preferred Stock [Member] | Warrant [Member] | |||||
Number of shares issued | 41,659 | ||||
Series A-1 Convertible Preferred Stock [Member] | Post-Merger [Member] | Enumeral Acquisition Corp [Member] | |||||
Conversion ratio | 1.790947 | ||||
Number of shares converted | 3,666,428 | ||||
Series A-2 Preferred Stock [Member] | Post-Merger [Member] | Enumeral Acquisition Corp [Member] | |||||
Conversion ratio | 1.997594 | ||||
Number of shares converted | 3,663,177 |
EQUITY (Details Narrative 1)
EQUITY (Details Narrative 1) - USD ($) | Jul. 31, 2014 | Dec. 31, 2015 | Jul. 31, 2014 | Apr. 30, 2014 | Sep. 30, 2016 |
Legal expenses | $ 122,512 | ||||
Placement Agent [Member] | |||||
Cash commission | $ 81,000 | ||||
Private Placement Offering [Member] | |||||
Number of units issued | 21,549,510 | ||||
Share price (in dollars per unit) | $ 1 | $ 1 | |||
Net proceeds received | $ 18,255,444 | ||||
Offering expense | $ 500,000 | ||||
Private Placement Offering [Member] | Placement Agent [Member] | |||||
Number of common shares issued | 150,000 | 150,000 | |||
Percent cash commission of gross funds raised | 10.00% | 10.00% | |||
Legal expenses | $ 30,000 | ||||
Cash commission | $ 2,154,951 | ||||
Private Placement Offering [Member] | Warrant [Member] | |||||
Number of shares consists in each unit | 1 | 23,549,509 | |||
Warrant exercise price (in dollars per share) | $ 2 | $ 2 | |||
Warrant terms | 5 years | 3 years 6 months 29 days | 5 years | 2 years 9 months 29 days | |
Private Placement Offering [Member] | Warrant [Member] | Placement Agent [Member] | |||||
Number of common shares issued | 2,000,000 | 2,000,000 | |||
Warrant exercise price (in dollars per share) | $ 1 | $ 1 | |||
Percentage of common stock purchased | 10.00% | 10.00% | |||
Private Placement Offering [Member] | Common Stock [Member] | |||||
Number of shares consists in each unit | 1 | ||||
Additional shares issued | 1,690,658 | ||||
Other expense related to issuance of shares | $ 1,690,658 |
LICENSE AGREEMENT AND RELATED44
LICENSE AGREEMENT AND RELATED-PARTY TRANSACTIONS (Details Narrative) - USD ($) | Apr. 01, 2011 | Apr. 30, 2013 | Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | Dec. 31, 2015 | Sep. 30, 2014 |
Research and development | $ 1,026,317 | $ 1,798,241 | $ 3,737,161 | $ 4,833,911 | ||||
Massachusetts Institute of Technology & Harvard University [Member] | ||||||||
Accounts payable and accrued expenses | 38,346 | 38,346 | $ 168,726 | |||||
Original License Agreement [Member] | Pieris Pharmaceuticals, Inc. & Pieris Pharmaceuticals GmbH [Member] | ||||||||
Accrual royalty | 100,000 | 100,000 | ||||||
Exclusive License Agreement [Member] | Massachusetts Institute of Technology [Member] | ||||||||
Payment to related party | 23,052 | 15,646 | 162,692 | 256,189 | ||||
Funding to related party | $ 7,500,000 | |||||||
Exclusive License Agreement [Member] | Harvard University [Member] | ||||||||
Payment to related party | 2,351 | 3,730 | 17,692 | 22,367 | ||||
Exclusive License Agreement [Member] | Intellectual Property (Patents) [Member] | Massachusetts Institute of Technology [Member] | ||||||||
Number of common shares issued | 66,303 | |||||||
Research and development | 10,000 | 7,500 | 30,000 | 22,500 | ||||
Annual royalty fees | 40,000 | |||||||
Annual royalty fees due thereafter | 50,000 | |||||||
Scientific Advisory Board Agreement [Member] | Dr. Barry Buckland, Ph.D. [Member] | ||||||||
Amount of compensation payable | $ 100,000 | |||||||
Recognized compensation expense | $ 4,000 | $ 4,000 | $ 8,000 | $ 27,000 |
STOCK OPTIONS, RESTRICTED STO45
STOCK OPTIONS, RESTRICTED STOCK AND WARRANTS (Details) - Stock Option [Member] | 9 Months Ended |
Sep. 30, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Expected term (in years) | 5 years |
Expected dividend yield | 0.00% |
Minimum [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Expected Volatility | 116.00% |
Risk-free interest rate | 1.20% |
Maximum [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Expected Volatility | 117.00% |
Risk-free interest rate | 1.72% |
STOCK OPTIONS, RESTRICTED STO46
STOCK OPTIONS, RESTRICTED STOCK AND WARRANTS (Details 1) | 9 Months Ended |
Sep. 30, 2016$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | |
Outstanding at beginning | shares | 5,926,654 |
Granted | shares | 4,068,182 |
Exercised | shares | |
Canceled | shares | (1,247,476) |
Outstanding at ending | shares | 8,747,360 |
Exercisable at ending | shares | 4,910,317 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price [Roll Forward] | |
Outstanding at beginning | $ / shares | $ 0.62 |
Granted | $ / shares | 0.20 |
Exercised | $ / shares | |
Canceled | $ / shares | 0.72 |
Outstanding at ending | $ / shares | 0.41 |
Exercisable at ending | $ / shares | $ 0.46 |
Share-based Compensation Arrangement by Share-based Payment Award, Options,Weighted Average Remaining Contractual Term [Roll Forward] | |
Outstanding at beginning | 9 years |
Outstanding at ending | 8 years 10 months 24 days |
Exercisable at ending | 8 years 6 months |
STOCK OPTIONS, RESTRICTED STO47
STOCK OPTIONS, RESTRICTED STOCK AND WARRANTS (Details 2) - Restricted Stock [Member] | 9 Months Ended |
Sep. 30, 2016$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | |
Balance of unvested at beginning | shares | 282,119 |
Issuance of restricted stock | shares | 140,910 |
Vested | shares | (380,362) |
Balance of unvested at ending | shares | 42,667 |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value [Roll Forward] | |
Balance of unvested at beginning | $ / shares | $ 0.24 |
Issuance of restricted stock | $ / shares | 0.22 |
Vested | $ / shares | 0.23 |
Balance of unvested at ending | $ / shares | $ 0.22 |
STOCK OPTIONS, RESTRICTED STO48
STOCK OPTIONS, RESTRICTED STOCK AND WARRANTS (Details Narrative) - USD ($) | Sep. 21, 2016 | Jul. 31, 2014 | Jun. 12, 2012 | Sep. 30, 2016 | Dec. 31, 2015 | Jul. 31, 2014 | Dec. 31, 2011 | Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | Jan. 02, 2016 |
Recognition period | 1 year 10 months 24 days | |||||||||||
Warrant outstanding | 24,803,409 | 24,803,409 | 24,803,409 | |||||||||
Number of option granted | 4,068,182 | |||||||||||
Mr. Wael Fayad [Member] | Offer Letter Agreement [Member] | ||||||||||||
Number of shares available for purchase | 2,600,000 | 2,600,000 | 2,600,000 | |||||||||
Number of shares vested | 100,000 | |||||||||||
Number of shares vested for achievement of certain performance-based milestones | 2,500,000 | |||||||||||
Number of option granted | 2,600,000 | |||||||||||
Private Placement Offering [Member] | Placement Agent [Member] | ||||||||||||
Number of common shares issued | 150,000 | 150,000 | ||||||||||
Warrant [Member] | ||||||||||||
Warrant outstanding | 1,187,325 | 1,187,325 | 1,187,325 | |||||||||
Warrant [Member] | Square 1 Bank [Member] | ||||||||||||
Warrant outstanding | 66,574 | 66,574 | 66,574 | |||||||||
Fair value of warrant | $ 5,777 | $ 3,358 | ||||||||||
Warrant terms | 2 years 10 months 24 days | 2 years 2 months 5 days | ||||||||||
Volatility | 104.60% | 106.40% | ||||||||||
Risk-free rate | 1.31% | 0.79% | ||||||||||
Expected dividends | 0.00% | 0.00% | ||||||||||
Expiration date | Jun. 12, 2019 | Dec. 5, 2018 | ||||||||||
Warrant [Member] | Square 1 Bank [Member] | Merger Agreement [Member] | ||||||||||||
Number of common shares issued | 12,329 | 12,329 | ||||||||||
Exercise price (in dollars per share) | $ 0.73 | $ 0.73 | ||||||||||
Fair value of warrant | $ 940 | $ 1,492 | ||||||||||
Warrant terms | 2 years 8 months 12 days | 3 years 6 months | ||||||||||
Volatility | 106.40% | 104.60% | ||||||||||
Risk-free rate | 0.85% | 1.42% | ||||||||||
Expected dividends | 0.00% | 0.00% | ||||||||||
Warrant [Member] | Private Placement Offering [Member] | ||||||||||||
Warrant outstanding | 23,549,510 | 23,549,510 | 23,549,510 | 23,549,510 | ||||||||
Exercise price (in dollars per share) | $ 2 | $ 2 | ||||||||||
Fair value of warrant | $ 2,130,822 | $ 16,261,784 | $ 901,368 | |||||||||
Warrant terms | 5 years | 3 years 6 months 29 days | 5 years | 2 years 9 months 29 days | ||||||||
Volatility | 109.40% | 105.40% | 106.40% | |||||||||
Risk-free rate | 1.44% | 1.77% | 0.86% | |||||||||
Expected dividends | 0.00% | 0.00% | 0.00% | |||||||||
Warrant [Member] | Private Placement Offering [Member] | Placement Agent [Member] | ||||||||||||
Number of common shares issued | 2,000,000 | 2,000,000 | ||||||||||
Exercise price (in dollars per share) | $ 1 | $ 1 | ||||||||||
Warrant [Member] | Private Placement Offering [Member] | Investors [Member] | ||||||||||||
Number of common shares issued | 21,549,510 | 21,549,510 | ||||||||||
Exercise price (in dollars per share) | $ 2 | $ 2 | ||||||||||
Restricted Stock [Member] | ||||||||||||
Stock option compensation expense | $ 20,633 | $ 17,200 | $ 79,551 | $ 59,025 | ||||||||
Enumeral Acquisition Corp [Member] | Warrant [Member] | Square 1 Bank [Member] | ||||||||||||
Number of common shares issued | 54,245 | 54,245 | 33,944 | |||||||||
Exercise price (in dollars per share) | $ 0.73 | $ 0.73 | $ 1.16 | |||||||||
Warrant terms | 7 years | |||||||||||
Enumeral Acquisition Corp [Member] | Warrant [Member] | Square 1 Bank [Member] | Placement Agent [Member] | ||||||||||||
Number of common shares issued | 66,574 | 66,574 | 41,659 | |||||||||
Enumeral Acquisition Corp [Member] | Warrant [Member] | Square 1 Bank [Member] | Placement Agent [Member] | Loan And Security Agreement [Member] | ||||||||||||
Number of common shares issued | 7,715 | |||||||||||
Exercise price (in dollars per share) | $ 1.16 | |||||||||||
Warrant terms | 7 years | |||||||||||
2014 Equity Incentive Plan [Member] | ||||||||||||
Number of shares authorized | 8,100,000 | 8,100,000 | ||||||||||
Number of shares available for purchase | 187,481 | 187,481 | 187,481 | |||||||||
Weighted-average fair value (in dollars per share) | $ 0.16 | $ 0.16 | $ 0.16 | |||||||||
Stock option compensation expense | $ 260,343 | $ 167,575 | $ 803,747 | $ 418,641 | ||||||||
Unrecognized compensation expense | $ 272,771 | 272,771 | $ 272,771 | |||||||||
Recognition period | 1 year 10 months 24 days | |||||||||||
Intrinsic value of options exercisable | $ 4,712 | 4,712 | $ 4,712 | |||||||||
2014 Equity Incentive Plan [Member] | Mr. Arthur H. Tinkelenberg [Member] | ||||||||||||
Stock option compensation expense | $ 15,580 | |||||||||||
2014 Equity Incentive Plan [Member] | Mr. Wael Fayad [Member] | Offer Letter Agreement [Member] | ||||||||||||
Number of shares available for purchase | 850,000 | 850,000 | 850,000 | |||||||||
Description of vesting rights | (i) 100,000 options vested immediately upon grant and (ii) 2,500,000 options vest upon the achievement of certain performance-based milestones. | |||||||||||
Number of option granted | 850,000 | |||||||||||
2014 Equity Incentive Plan [Member] | Mr. John J. Rydzewski [Member] | Separation Letter Agreement [Member] | ||||||||||||
Stock option compensation expense | $ 83,361 | |||||||||||
Number of shares vested | 703,326 | |||||||||||
2014 Equity Incentive Plan [Member] | Minimum [Member] | ||||||||||||
Forfeiture rate | 0.00% | |||||||||||
2014 Equity Incentive Plan [Member] | Maximum [Member] | ||||||||||||
Forfeiture rate | 5.00% | |||||||||||
2014 Equity Incentive Plan [Member] | Enumeral Acquisition Corp [Member] | ||||||||||||
Number of shares available for purchase | 1,045,419 | 1,045,419 | ||||||||||
2009 Stock Incentive Plan [Member] | Enumeral Acquisition Corp [Member] | ||||||||||||
Number of shares available for purchase | 948,567 | 948,567 | ||||||||||
Outside 2014 Equity Incentive Plan [Member] | Mr. Wael Fayad [Member] | Offer Letter Agreement [Member] | ||||||||||||
Number of option granted | 1,750,000 |
CONCENTRATIONS (Details Narrati
CONCENTRATIONS (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | Dec. 31, 2015 | |
Concentration Risk [Line Items] | |||||
Accounts receivable | $ 265,537 | $ 265,537 | $ 306,012 | ||
Customer Concentration Risk [Member] | Revenue In Excess Of 10% [Member] | Entity One [Member] | |||||
Concentration Risk [Line Items] | |||||
Percentage | 70.00% | 82.00% | 44.00% | 78.00% | |
Revenue | $ 226,115 | $ 395,448 | $ 1,000,000 | $ 894,132 | |
Customer Concentration Risk [Member] | Revenue In Excess Of 10% [Member] | Entity Two [Member] | |||||
Concentration Risk [Line Items] | |||||
Percentage | 30.00% | 18.00% | 39.00% | 22.00% | |
Revenue | $ 94,696 | $ 88,377 | $ 878,599 | $ 245,728 | |
Customer Concentration Risk [Member] | Revenue In Excess Of 10% [Member] | Entity Three [Member] | |||||
Concentration Risk [Line Items] | |||||
Percentage | 17.00% | ||||
Revenue | $ 375,641 | ||||
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Entity One [Member] | |||||
Concentration Risk [Line Items] | |||||
Percentage | 15.00% | 67.00% | |||
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Entity Two [Member] | |||||
Concentration Risk [Line Items] | |||||
Percentage | 85.00% | 33.00% |
SUBSEQUENT EVENTS (Details Narr
SUBSEQUENT EVENTS (Details Narrative) - $ / shares | Oct. 28, 2016 | Sep. 30, 2016 | Dec. 31, 2015 | Jul. 31, 2014 |
Subsequent Event [Line Items] | ||||
Number of warrant outstanding | 24,803,409 | |||
Warrant [Member] | ||||
Subsequent Event [Line Items] | ||||
Number of warrant outstanding | 1,187,325 | |||
Private Placement Offering [Member] | Warrant [Member] | ||||
Subsequent Event [Line Items] | ||||
Number of warrant outstanding | 23,549,510 | 23,549,510 | ||
Exercise price (in dollars per share) | $ 2 | |||
Subsequent Event [Member] | Offer to Amend & Exercise [Member] | Private Placement Offering [Member] | Warrant [Member] | ||||
Subsequent Event [Line Items] | ||||
Number of warrant outstanding | 21,549,510 | |||
Exercise price (in dollars per share) | $ 2 | |||
Number of common shares exercised by each warrant | 1 | |||
Subsequent Event [Member] | Offer to Amend & Exercise [Member] | Private Placement Offering [Member] | Amended Warrant [Member] | ||||
Subsequent Event [Line Items] | ||||
Exercise price (in dollars per share) | $ 0.50 | |||
Number of common shares exercised by each warrant | 4 | |||
Description of offer to amend & exercise offering | The Original Warrants of holders who elect to participate in the Offer to Amend and Exercise will be amended (the “Amended Warrants”) to: (i) receive four shares of common stock for each warrant exercised rather than one; (ii) reduce the exercise price to $0.50 per warrant in cash (or $0.125 per share based on the 4 common shares that they will receive upon exercise); (iii) shorten the exercise period so that it expires concurrently with the expiration of the Offer to Amend and Exercise at 5:00 p.m. (Eastern Time) on November 29, 2016, as such expiration date may be extended by the Company in its sole discretion, or as required by applicable law (the “Expiration Date”); (iv) delete any price-based anti-dilution provisions; (v) restrict the ability of the holder of shares issuable upon exercise of the Amended Warrants to sell, make any short sale of, loan, grant any option for the purchase of, or otherwise dispose of any of such shares without the prior written consent of the Company for a period of one hundred eighty (180) days after the Expiration Date (the “Lock-Up Period”); and (vi) provide that a holder, acting alone or with others, will agree not to effect any purchases or sales of any securities of the Company in any “short sales” as defined in Rule 200 promulgated under Regulation SHO under the Exchange Act, or any type of direct and indirect stock pledges, forward sale contracts, options, puts, calls, short sales, swaps, “put equivalent positions” (as defined in Rule 16a-1(h) under the Exchange Act) or similar arrangements, or sales or other transactions through non-U.S. broker dealers or foreign regulated brokers through the expiration of the Lock-Up Period. | |||
Description of offer to amend & exercise conditions | (i) A minimum of $2,000,000 in gross proceeds is received and (ii) holders of a majority of the Original Warrants agree to the Anti-Dilution Amendment (the “Majority Holders’ Consent”). If the Company receives the Majority Holders’ Consent to the Anti-Dilution Amendment, all of the Original Warrants will be amended such that the price based anti-dilution provision of the Original Warrants will no longer apply without regard to whether such holder provided consent. | |||
Description of anti-dilution provisions | (i) The majority of such holders granting such consent, and (ii) the Warrant Agent acting as such, to amend the PPO Agent Warrants to reduce the exercise price from $1.00 to $0.125 per share at the time of and in connection with the completion of the Offer to Amend and Exercise. |