Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2017 | Nov. 07, 2017 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2017 | |
Document Fiscal Year Focus | 2,017 | |
Document Fiscal Period Focus | Q3 | |
Entity Registrant Name | Cytosorbents Corp | |
Entity Central Index Key | 1,175,151 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Trading Symbol | CTSO | |
Entity Common Stock, Shares Outstanding | 28,691,325 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Sep. 30, 2017 | Dec. 31, 2016 |
Current Assets: | ||
Cash and cash equivalents | $ 15,400,348 | $ 5,245,178 |
Grants and accounts receivable, net of allowance for doubtful accounts of $76,601 at September 30, 2017 and $65,414 at December 31, 2016 | 2,350,190 | 1,433,468 |
Inventories | 1,089,343 | 833,976 |
Prepaid expenses and other current assets | 546,124 | 315,802 |
Total current assets | 19,386,005 | 7,828,424 |
Property and equipment, net | 1,032,789 | 569,409 |
Other assets | 1,799,515 | 1,296,011 |
Total long-term assets | 2,832,304 | 1,865,420 |
Total Assets | 22,218,309 | 9,693,844 |
Current Liabilities: | ||
Accounts payable | 1,288,230 | 1,330,072 |
Current maturities of long-term debt | 3,000,000 | 833,333 |
Accrued expenses and other current liabilities | 1,489,931 | 2,114,666 |
Total current liabilities | 5,778,161 | 4,278,071 |
Long-term debt, net of current maturities and debt acquisition costs | 6,966,355 | 4,078,314 |
Total Liabilities | 12,744,516 | 8,356,385 |
Commitments and Contingencies (Note 6) | ||
Stockholders’ Equity: | ||
Preferred Stock, par value $0.001, 5,000,000 shares authorized; -0- shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively | 0 | 0 |
Common Stock, par value $0.001, 50,000,000 shares authorized; 28,481,082 and 25,483,966 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively | 28,481 | 25,484 |
Additional paid-in capital | 158,734,206 | 143,929,397 |
Accumulated other comprehensive income (loss) | (123,277) | 898,684 |
Accumulated deficit | (149,165,617) | (143,516,106) |
Total stockholders' equity | 9,473,793 | 1,337,459 |
Total Liabilities and Stockholders' Equity | $ 22,218,309 | $ 9,693,844 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) | Sep. 30, 2017 | Dec. 31, 2016 |
Allowance for doubtful accounts | $ 76,601 | $ 65,414 |
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 |
Preferred Stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred Stock, shares issued | 0 | 0 |
Preferred Stock, shares outstanding | 0 | 0 |
Common Stock, Par Value | $ 0.001 | $ 0.001 |
Common Stock, shares authorized | 50,000,000 | 50,000,000 |
Common Stock, shares issued | 28,481,082 | 25,483,966 |
Common Stock, shares outstanding | 28,481,082 | 25,483,966 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Revenue: | ||||
Sales | $ 3,448,661 | $ 2,143,116 | $ 9,085,806 | $ 5,593,235 |
Grant income | 375,638 | 268,592 | 1,418,237 | 850,993 |
Total revenue | 3,824,299 | 2,411,708 | 10,504,043 | 6,444,228 |
Cost of revenue | 1,516,864 | 963,881 | 4,253,357 | 2,656,646 |
Gross profit | 2,307,435 | 1,447,827 | 6,250,686 | 3,787,582 |
Other expenses: | ||||
Research and development | 537,949 | 1,172,155 | 1,628,261 | 3,120,347 |
Legal, financial and other consulting | 238,303 | 279,321 | 961,444 | 853,056 |
Selling, general and administrative | 3,680,228 | 2,140,563 | 9,698,412 | 6,735,856 |
Total expenses | 4,456,480 | 3,592,039 | 12,288,117 | 10,709,259 |
Loss from operations | (2,149,045) | (2,144,212) | (6,037,431) | (6,921,677) |
Other income/(expense): | ||||
Interest expense, net | (253,780) | (117,352) | (497,683) | (111,864) |
Gain on foreign currency transactions | 348,546 | 73,445 | 1,221,334 | 176,096 |
Total other income (expense), net | 94,766 | (43,907) | 723,651 | 64,232 |
Loss before benefit from income taxes | (2,054,279) | (2,188,119) | (5,313,780) | (6,857,445) |
Benefit from income taxes | 0 | 0 | 0 | 0 |
Net loss | (2,054,279) | (2,188,119) | (5,313,780) | (6,857,445) |
Dividend, warrant exercise price adjustment | 0 | 0 | 335,731 | 0 |
Net loss available to common stockholders | $ (2,054,279) | $ (2,188,119) | $ (5,649,511) | $ (6,857,445) |
Basic and diluted net loss per share of Common Stock | $ (0.07) | $ (0.09) | $ (0.21) | $ (0.27) |
Weighted average number of shares of Common Stock outstanding | 28,206,437 | 25,444,565 | 27,231,145 | 25,420,650 |
Net loss | $ (2,054,279) | $ (2,188,119) | $ (5,313,780) | $ (6,857,445) |
Other comprehensive loss: | ||||
Currency translation adjustment | (280,078) | (60,820) | (1,021,961) | (161,593) |
Comprehensive loss | $ (2,334,357) | $ (2,248,939) | $ (6,335,741) | $ (7,019,038) |
CONSOLIDATED STATEMENT OF CHANG
CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($) | Total | Common Stock [Member] | Paid-In Capital [Member] | Accumulated Other Comprehensive Income [Member] | Accumulated Deficit [Member] |
Adjustment (see note 3) | Restatement Adjustment [Member] | $ 1,811,547 | $ 0 | $ 862,920 | $ 0 | $ 948,627 |
Beginning Balance (Scenario, Previously Reported [Member]) at Dec. 31, 2016 | (474,088) | 25,484 | 143,066,477 | 898,684 | (144,464,733) |
Beginning Balance at Dec. 31, 2016 | 1,337,459 | $ 25,484 | 143,929,397 | 898,684 | (143,516,106) |
Beginning Balance (in shares) (Scenario, Previously Reported [Member]) at Dec. 31, 2016 | 25,483,966 | ||||
Beginning Balance (in shares) at Dec. 31, 2016 | 25,483,966 | ||||
Stock based compensation - employees, consultants and directors | 1,851,020 | $ 0 | 1,851,020 | 0 | 0 |
Issuance of common stock-offering, net of fees incurred | 11,971,463 | $ 2,838 | 11,968,625 | 0 | 0 |
Issuance of common stock-offering, net of fees incurred (in shares) | 2,837,949 | ||||
Other comprehensive income/(loss): foreign translation adjustment | (1,021,961) | $ 0 | 0 | (1,021,961) | 0 |
Issuance of restricted stock units | 207,608 | $ 41 | 207,567 | 0 | 0 |
Issuance of restricted stock units (in shares) | 41,390 | ||||
Cashless exercise of stock options | 0 | $ 2 | (2) | 0 | 0 |
Cashless exercise of stock options (in shares) | 2,074 | ||||
Proceeds from exercise of warrants | 260,504 | $ 59 | 260,445 | 0 | 0 |
Proceeds from exercise of warrants (in shares) | 59,001 | ||||
Proceeds from exercise of stock options | 181,480 | $ 57 | 181,423 | 0 | 0 |
Proceeds from exercise of stock options (in shares) | 56,702 | ||||
Dividend, warrant exercise price adjustment | 0 | $ 0 | 335,731 | 0 | (335,731) |
Net loss | (5,313,780) | 0 | 0 | 0 | (5,313,780) |
Ending Balance at Sep. 30, 2017 | $ 9,473,793 | $ 28,481 | $ 158,734,206 | $ (123,277) | $ (149,165,617) |
Ending Balance (in shares) at Sep. 30, 2017 | 28,481,082 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 9 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Cash flows from operating activities: | ||
Net loss | $ (5,313,780) | $ (6,857,445) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization expense | 161,688 | 109,395 |
Amortization of debt costs | 56,268 | 15,240 |
Bad debt expense | 3,897 | 0 |
Stock-based compensation | 1,851,020 | 724,025 |
Foreign currency transaction gain | (1,221,334) | (176,096) |
Changes in operating assets and liabilities: | ||
Grants and accounts receivable | (803,348) | (747,117) |
Inventories | (227,882) | 143,200 |
Prepaid expenses and other current assets | (8,528) | 295,516 |
Other assets | (15,000) | (21,363) |
Accounts payable and accrued expenses | (534,222) | 862,754 |
Net cash used by operating activities | (6,051,221) | (5,651,891) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (579,944) | (155,696) |
Payments for patent costs | (516,203) | (341,665) |
Proceeds from redemptions of short-term investments | 0 | 2,192,000 |
Net cash provided (used) by investing activities | (1,096,147) | 1,694,639 |
Cash flows from financing activities: | ||
Equity contributions - net of fees incurred | 11,775,046 | 0 |
Proceeds from long-term debt | 5,000,000 | 5,000,000 |
Payment of debt acquisition costs | (1,560) | (118,833) |
Proceeds from exercise of stock options | 181,480 | 79,990 |
Proceeds from exercise of warrants | 260,504 | 50,000 |
Net cash provided by financing activities | 17,215,470 | 5,011,157 |
Effect of exchange rates on cash | 87,068 | 4,293 |
Net increase in cash and cash equivalents | 10,155,170 | 1,058,198 |
Cash and cash equivalents - beginning of period | 5,245,178 | 5,316,851 |
Cash and cash equivalents - end of period | 15,400,348 | 6,375,049 |
Supplemental disclosure of cash flow information: | ||
Cash paid during the period for interest | 407,347 | 71,233 |
Supplemental schedule of noncash investing and financing activities: | ||
Settlement of accrued bonuses with restricted stock units | 207,608 | 0 |
Dividend, warrant exercise price adjustment | 335,731 | 0 |
Proceeds of stock sale not received | $ 196,417 | $ 0 |
BASIS OF PRESENTATION
BASIS OF PRESENTATION | 9 Months Ended |
Sep. 30, 2017 | |
BASIS OF PRESENTATION [Abstract] | |
BASIS OF PRESENTATION | 1. BASIS OF PRESENTATION The interim financial statements of CytoSorbents Corporation (the “Company”) have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). In the opinion of management, the Company has made all necessary adjustments, which include normal recurring adjustments necessary for a fair statement of the Company’s financial position and results of operations for the interim periods presented. Certain information and disclosures normally included in the annual financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. These interim financial statements should be read in conjunction with the audited financial statements and accompanying notes for the year ended December 31, 2016 included in the Company’s Annual Report on Form 10-K, as filed with the Securities and Exchange Commission on March 3, 2017. The results for the three and nine months ended September 30, 2017 and 2016 are not necessarily indicative of the results to be expected for a full year, any other interim periods or any future year or period. The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. As of September 30, 2017, the Company had an accumulated deficit of $ 149,165,617 5,313,780 6,857,445 |
PRINCIPAL BUSINESS ACTIVITY AND
PRINCIPAL BUSINESS ACTIVITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended |
Sep. 30, 2017 | |
PRINCIPAL BUSINESS ACTIVITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES [Abstract] | |
PRINCIPAL BUSINESS ACTIVITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 2. PRINCIPAL BUSINESS ACTIVITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES The Company is a leader in critical care immunotherapy, investigating and commercializing its CytoSorb blood purification therapy to reduce deadly uncontrolled inflammation in hospitalized patients around the world, with the goal of preventing or treating multiple organ failure in life-threatening illnesses. The Company, through its subsidiary CytoSorbents Medical Inc. (formerly known as CytoSorbents, Inc.), is engaged in the research, development and commercialization of medical devices with its blood purification technology platform which incorporates a proprietary adsorbent, porous polymer technology. The Company, through its subsidiary, CytoSorbents Europe GmbH, conducts sales and marketing related operations for the CytoSorb device. In March 2016, the Company formed CytoSorbents Switzerland GmbH, a wholly-owned subsidiary of CytoSorbents Europe GmbH. This subsidiary, which began operations during the second quarter of 2016, provides marketing and direct sales services in Switzerland. CytoSorb , The technology is based upon biocompatible, highly porous polymer sorbent beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface absorption. The Company has numerous products under development based upon this unique blood purification technology, which include HemoDefend, ContrastSorb, DrugSorb, and others. As of September 30, 2017, the Company owns 32 issued United States patents and has multiple issued patents and pending patent applications worldwide. Our patent portfolio includes 16 issued United States patents as well as multiple issued patents and pending patent applications directed to various compositions and methods of use related to our blood purifications technologies, which are expected to expire between 2018 and 2031, absent any patent term extensions. Management believes that any expiring patents will not have a significant impact on our ongoing business. On December 17, 2014 the Company’s common stock, par value $ 0.001 The consolidated financial statements include the accounts of the parent, CytoSorbents Corporation, and its wholly-owned subsidiaries, CytoSorbents Medical, Inc. and CytoSorbents Europe GmbH. In addition, the financial statements include CytoSorbents Switzerland GmbH, a wholly owned subsidiary of CytoSorbents Europe GmbH. All significant intercompany transactions and balances have been eliminated in consolidation. Translation gains and losses resulting from the process of remeasuring into the U.S. dollar, the foreign currency financial statements of CytoSorbents Europe GmbH, for which the U.S. dollar is the functional currency, are included in operations. Foreign currency transaction gain amounted to $ 348,546 73,445 1,221,334 176,096 The Company considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. Grants receivable represent amounts due from U.S. government agencies and are included in Grants and Accounts Receivable. Accounts receivable are unsecured, non-interest bearing customer obligations due under normal trade terms. The Company sells its devices to various hospitals and distributors. The Company performs ongoing credit evaluations of customers’ financial condition. Management reviews accounts receivable periodically to determine collectability. Balances that are determined to be uncollectible are written off to the allowance for doubtful accounts. The allowance for doubtful accounts contains a general accrual for estimated bad debts and amounted to approximately $ 77,000 65,000 Inventories are valued at the lower of cost or market. At September 30, 2017 and December 31, 2016, the Company’s inventory was comprised of finished goods, which amounted to $ 351,642 307,483 648,131 467,663 89,570 58,830 Property and equipment are recorded at cost less accumulated depreciation. Depreciation of property and equipment is provided for by the straight-line method over the estimated useful lives of the related assets. Leasehold improvements are amortized over the lesser of their economic useful lives or the term of the related leases. Gains and losses on depreciable assets retired or sold are recognized in the statements of operations in the year of disposal. Repairs and maintenance expenditures are expensed as incurred. Legal costs incurred to establish and successfully defend patents are capitalized. When patents are issued, capitalized costs are amortized on the straight-line method over the related patent term. In the event a patent is abandoned, the net book value of the patent is written off. The Company assesses the impairment of patents and other long-lived assets under accounting standards for the impairment or disposal of long-lived assets whenever events or changes in circumstances indicate that the carrying value may not be recoverable. For long-lived assets to be held and used, the Company recognizes an impairment loss only if its carrying amount is not recoverable through its undiscounted cash flows and measures the impairment loss based on the difference between the carrying amount and fair value. Warrants (See Note 3) The Company recognizes the fair value of the warrants with a down round feature as a component of stockholders’ equity as of the date of the warrant grant. When the down round feature is triggered, the Company remeasures the fair value of the warrants, and records the change in fair value as a dividend and as a reduction in net income available to common stockholders. Product Sales : Revenues from sales of products are recognized at the time when title and risk of loss passes to the customer. Recognition of revenue also requires reasonable assurance of collection of sales proceeds and completion of all performance obligations. Grant Revenue : Revenue from grant income is based on contractual agreements. Certain agreements provide for reimbursement of costs, while other agreements provide for reimbursement of costs and an overhead margin. Revenues are recognized when milestones have been achieved and revenues have been earned. Costs are recorded as incurred. Costs subject to reimbursement by these grants have been reflected as costs of revenue. All research and development costs, payments to laboratories and research consultants and costs of clinical trials and studies are expensed when incurred. Advertising expenses are charged to activities when incurred. Advertising expenses amounted to approximately $ 45,000 28,000 132,000 153,000 Income taxes are accounted for under the asset and liability method prescribed by accounting standards for accounting for income taxes. Deferred income taxes are recorded for temporary differences between financial statement carrying amounts and the tax basis of assets and liabilities. Deferred tax assets and liabilities reflect the tax rates expected to be in effect for the years in which the differences are expected to reverse. A valuation allowance is provided if it is more likely than not that some or all of the deferred tax asset will not be realized. Under Section 382 of the Internal Revenue Code, the net operating losses generated prior to the previously completed reverse merger may be limited due to the change in ownership. Additionally, net operating losses generated subsequent to the reverse merger may be limited in the event of changes in ownership. The Company follows accounting standards associated with uncertain tax positions. The Company had no unrecognized tax benefits at September 30, 2017 or December 31, 2016. The Company files tax returns in the U.S. federal and various state jurisdictions. The Company utilizes the Technology Business Tax Certificate Transfer Program to sell a portion of its New Jersey Net Operating Loss carry forwards to an industrial company. Each of CytoSorbents Europe GmbH and CytoSorbents Switzerland GmbH files an annual corporate tax return, VAT return and a trade tax return in Germany and Switzerland, respectively. The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities. Actual results could differ from these estimates. Significant estimates in these financials are the valuation of options granted, and valuation methods used to determine the fair value of the warrant liability. The Company maintains cash balances, at times, with financial institutions in excess of amounts insured by the Federal Deposit Insurance Corporation. Management monitors the soundness of these institutions in an effort to minimize its collection risk of these balances. A significant portion of our revenues are from product sales in Germany. Substantially all of our grant and other income are from grant agencies in the United States. Three Months Ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 Product Sales: Germany $ 1,964,434 $ 1,327,193 $ 5,359,560 $ 3,653,995 All other countries 1,484,227 815,923 3,726,246 1,939,240 Grant and other income: United States 375,638 268,592 1,418,237 850,993 Total revenue $ 3,824,299 $ 2,411,708 $ 10,504,043 $ 6,444,228 As of September 30, 2017, two distributors accounted for approximately 33 22 10 11 10 11 Financial Instruments The carrying values of cash and cash equivalents, short-term investments, accounts payable, notes payable, and other debt obligations approximate their fair values due to their short-term nature. Basic earnings per share is computed by dividing loss available to common stockholders by the weighted average number of common shares outstanding during the period. Diluted earnings per common share is computed using the treasury stock method on the basis of the weighted-average number of shares of Common Stock plus the dilutive effect of potential common shares outstanding during the period. Dilutive potential common shares include outstanding warrants, stock options and restricted shares. The computation of diluted earnings per share does not assume conversion, exercise or contingent exercise of securities that would have an anti-dilutive effect on earnings (See Note 7). The Company accounts for its stock-based compensation under the recognition requirements of accounting standards for accounting for stock-based compensation, for employees and directors whereby each option granted is valued at fair market value on the date of grant. Under these accounting standards, the fair value of each option is estimated on the date of grant using the Black-Scholes option pricing model. The Company also follows the guidance of accounting standards for accounting for equity instruments that are issued to other than employees for acquiring, or in conjunction with selling, goods or services for equity instruments issued to consultants. In May 2014, the FASB issued ASU 2014-09, “Revenue with Contracts from Customers.” ASU 2014-09 supersedes the current revenue recognition guidance, including industry-specific guidance. The ASU introduces a five-step model to achieve its core principal of the entity recognizing revenue to depict the transfer of goods or services to customers at an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods and services. In August 2014, the FASB issued ASU 2015-14 which deferred the effective date by one year. Accordingly, the updated guidance is effective for public entities for interim and annual periods beginning after December 15, 2017 and early adoption is permitted as of the beginning of an interim or annual reporting period beginning after December 31, 2016. In 2016, the FASB issued ASU’s 2016-08, 2016-10 and 2016-12, all of which relate to this same topic and have the same effective date. The Company has evaluated the impact of these ASU’s and has determined that the adoption of this updated guidance may result in the deferral of revenue for certain distributors and strategic partners due to volume pricing discounts in the contracts. Also, revenues may be deferred on certain grant contracts with government agencies. The Company may also be required to capitalize costs incurred to obtain certain grant contracts and amortize these costs over the term of the related contract. Adoption of these ASU’s may require enhanced disclosures regarding contracts with customers including disaggregation of revenue, information about contract balances and performance obligations, significant judgments used in determining transaction price and assets recognized from costs to obtain a contract. In July 2015, the FASB issued ASU 2015-11, “Inventory: Simplifying the Measurement of Inventory.” ASU 2015-11 clarifies current guidance regarding the valuation of inventory. ASU 2015-11 requires that inventory be measured at the lower of cost or net realizable value. This ASU does not apply to inventory that is measured using the last-in, first-out (“LIFO”) or the retail inventory method. The updated guidance is effective for public entities for fiscal years beginning after December 15, 2016, and interim periods within fiscal years beginning after December 15, 2017. The Company has evaluated the impact of the updated guidance and has determined that the adoption of ASU 2015-11 is not expected to have a significant impact on its consolidated financial statements. In February 2016, the FASB issued ASU 2016-02, “Leases (Topic 842)”. ASU 2016-02 outlines reporting requirements for Lessees to recognize a right-of-use asset and corresponding liability on the balance sheet for all leases covering a period of greater than 12 months. The liability is to be measured as the present value of the future minimum lease payments, plus any initial direct costs. The minimum payments are discounted using the rate implicit in the lease, or, if not known, the lessee’s incremental borrowing rate. The updated guidance is effective for public entities for fiscal years beginning after December 31, 2018. The Company is evaluating the impact of the updated guidance and has determined that the adoption of ASU 2016-02 may impact certain financial statement disclosures, particularly with regard to leases of premises. In August 2016, the FASB issued ASU 2016-15, “Statement of Cash Flows Classification of Certain Cash Receipts and Cash Payments (a consensus of the Emerging Issues Task Force).” The amendments in this Update relate to eight specific types of cash receipts and cash payments which current GAAP either is unclear or does not include specific guidance on the cash flow classification issues. The amendments in this Update are effective for public business entities for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. Early adoption is permitted, including adoption in an interim period. If an entity early adopts the amendments in an interim period, any adjustments should be reflected as of the beginning of the fiscal year that includes that interim period. An entity that elects early adoption must adopt all of the amendments in the same period. The Company will adopt the provisions of this ASU for its fiscal year beginning January 1, 2018. The adoption of ASU 2016-15 is not expected to have a significant impact on its consolidated financial statements. In May 2017, the FASB issued ASU 2017-09, “Compensation – Stock Compensation (Topic 718). The amendments in this Update provide guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting in Topic 718. The amendments in this Update are effective for all entities for annual periods, and interim periods within those annual periods, beginning after December 15, 2017. Early adoption is permitted, including adoption in any interim period, for (1) public business entities for reporting periods for which financial statements have not yet been issued and (2) all other entities for reporting periods for which financial statements have not yet been made available for issuance. The amendments in this Update should be applied prospectively to an award modified on or after the adoption date. The Company is evaluating the impact of the revised guidance and believes that this will not have a significant impact on its consolidated financial statements. In July 2017, the FASB issued ASU 2017-11, “Earning Per Share (Topic 260); Distinguishing Liabilities from Equity (Topic 480); Derivatives and Hedging (Topic 815). Part I of this Update addresses the complexity of accounting for certain financial instruments with down round features. The amendments in Part I of this Update change the classification analysis of certain equity-linked financial instruments (or embedded features) with down round features. When determining whether certain financial instruments should be classified as liabilities or equity instruments, a down round feature no longer precludes equity classification when assessing whether the instrument is indexed to an entity’s own stock. The amendments also clarify existing disclosure requirements for equity-classified instruments. For public business entities, the amendments in Part I of this Update are effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018. For all other entities, the amendments in Part I of this Update are effective for fiscal years beginning after December 15, 2019, and interim periods within fiscal years beginning after December 15, 2020. Early adoption is permitted for all entities, including adoption in an interim period. If an entity early adopts the amendments in an interim period, any adjustments should be reflected as of the beginning of the fiscal year that includes that interim period. The Company has elected to adopt the provisions of this ASU as of September 30, 2017 and has restated its current and comparative financial statements within this quarterly filing accordingly. (See Note 3). The cost of shipping product to customers and distributors is typically borne by the customer or distributor. The Company records other shipping and handling costs in Research and Development. Total freight costs amounted to approximately $ 50,000 28,000 178,000 99,000 |
ADOPTION OF NEW ACCOUNTING STAN
ADOPTION OF NEW ACCOUNTING STANDARD AND RESTATEMENT | 9 Months Ended |
Sep. 30, 2017 | |
New Accounting Pronouncements and Changes in Accounting Principles [Abstract] | |
ADOPTION OF NEW ACCOUNTING STANDARD AND RESTATEMENT | 3. ADOPTION OF NEW ACCOUNTING STANDARD AND RESTATEMENT Effective September 30, 2017, the Company adopted the provisions of Accounting Standards Update (“ASU”) 2017-11, “Earning Per Share (Topic 260); Distinguishing Liabilities from Equity (Topic 480); Derivatives and Hedging (Topic 815). The provisions of this ASU change the classification analysis of certain equity-linked financial instruments (or embedded features) with down round features. The fair value of a financial instrument with a down round feature is now required to be classified as a component of stockholders equity, as opposed to a liability as it was previously required to be reported. In addition, this recorded fair value of the financial instrument is no longer to be subsequently remeasured. When the down round feature of the financial instrument is triggered due to a change in the underlying strike price, the change in the fair value is now required to be treated as a dividend and as a reduction of income available to common stockholders in accordance with the guidance of ASC-260. Accordingly, the Company has restated its current and historical financial statements to properly reflect the provisions of this ASU as discussed below. Prior accounting treatment In connection with its March 11, 2014 offering, the Company issued warrants to purchase 816,000 862,920 4.50 4.50 Current accounting treatment. The warrant liability has been eliminated from the Company’s balance sheets for the quarterly periods and years 2014, 2015, 2016, and 2017. As of January 1, 2016, the fair value of the warrant liability amounted to $ 1,636,128 773,208 862,920 494,596 666,815 765,106 948,627 862,920 As a result of the repricing of the warrants which occurred in connection with the April 2017 equity offering, the Company additionally recorded a dividend of $ 335,731 |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 9 Months Ended |
Sep. 30, 2017 | |
STOCKHOLDERS' EQUITY [Abstract] | |
STOCKHOLDERS' EQUITY | STOCKHOLDERS' EQUITY Preferred Stock In December 2014, the Company amended and restated its articles of incorporation to reduce the total number of authorized shares of preferred stock. The amended and restated articles of incorporation authorize the issuance of up to 5,000,000 Common Stock Shelf Registration On July 29, 2015, the Company’s registration statement on Form S-3, as filed with the SEC on July 23, 2015, was declared effective using a “shelf” registration process. Under this shelf registration statement, the Company may issue, in one or more offerings, any combination of Common Stock, preferred stock, senior or subordinated debt securities, warrants, or units, up to a total dollar amount of $ 100 April 5, 2017 Equity Offering On April 5, 2017, the Company closed on the sale of an aggregate of 2,222,222 10,000,000 4.50 On April 11, 2017, the Company closed the sale of an additional 333,333 1,500,000 11,500,000 $ 10,300,000 4.50 November 4, 2015 Controlled Equity Offering On November 4, 2015, the Company entered into a Controlled Equity Offering SM 25,000,000 Under the Sales Agreement, Cantor may sell Shares by any method permitted by law and deemed to be an “at the market offering” as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, including sales made directly on NASDAQ, on any existing trading market for the Common Stock or to or through a market maker. In addition, under the Sales Agreement, Cantor may sell the Shares by any other method permitted by law, including in privately negotiated transactions. The Company may instruct Cantor not to sell Shares if the sales cannot be effected at or above the price designated by the Company from time to time. The Company is not obligated to make any sales of Shares under the Sales Agreement, and if it elects to make any sales, the Company can set a minimum sales price for the Shares. The offering of Shares pursuant to the Sales Agreement will terminate upon the earlier of (a) the sale of all the shares subject to the Sales Agreement and (b) the termination of the Sales Agreement by Cantor or the Company, as permitted therein. From November 4, 2015 through December 31, 2015, the Company sold 28,880 225,000 282,394 1,659,000 196,000 held in escrow and From October 1, 2017 through November 7, 2017, the 157,398 980,000 468,672 6.30 2,863,000 The Company pays a commission rate of 3.0 50,000 The Company intends to use the net proceeds raised through “at the market” sales for research and development activities, which include the funding of additional clinical studies and costs of obtaining regulatory approvals in countries not covered by the CE Mark, capital expenditures and other costs necessary to expand production capacity, support of various sales and marketing efforts, product development and general working capital purposes. As a result of the repricing of the warrants which occurred in connection with the April 2017 equity offering, the Company recorded a dividend of $ 335,731 Stock-Based Compensation Stock Options: Total share-based employee, director, and consultant compensation for the three months and nine months ended September 30, 2017 and 2016 amounted to approximately $ 960,000 124,000 1,851,000 599,000 28,000 29,000 73,000 121,000 932,000 95,000 1,778,000 478,000 Weighted Weighted Average Average Remaining Exercise Price Contractual Shares per Share Life (Years) Outstanding, December 31, 2016 2,762,177 $ 4.69 6.0 Granted 1,180,950 5.45 9.7 Forfeited (17,640) 4.65 — Expired (32,120) 36.33 — Exercised (74,180) 3.56 — Outstanding, September 30, 2017 3,819,187 $ 4.68 6.8 The fair value of each stock option was estimated using the Black Scholes pricing model which takes into account as of the grant date the exercise price (ranging from $ 3.45 6.20 10 66.8 80.8 0 1.24 1.85 Options Outstanding Number Weighted Weighted Range of Outstanding at Average Average Aggregate Exercise September 30, Exercise Remaining Intrinsic Price 2017 Price Life (Years) Value $0.88 - $11.48 3,819,187 $ 4.68 6.8 $ 6,045,932 Options Exercisable Number Weighted Exercisable at Average Aggregate September 30, Exercise Intrinsic 2017 Price Value 2,592,062 $ 4.31 $ 5,125,994 Weighted Average Grant Date Shares Fair Value Non-vested, January 1, 2017 912,547 $ 2.55 Granted 1,180,950 0.58 Forfeited (1,000) 2.41 Vested (865,372) 2.36 Non-vested, September 30, 2017 1,227,125 $ 0.62 As of September 30, 2017, the Company had approximately $ 470,000 On February 24, 2017, the Board of Directors granted options to purchase 953,200 3,284,000 821,000 1,478,000 In April 2015, the Board of Directors also granted 960,000 7,747,200 240,000 1,936,000 75,000 414,000 1,941,660 1,539,000 129,500 725,200 1,668,500 Performance Based Stock Awards: Pursuant to a review of the compensation of the senior management of the Company, on June 7, 2016, the Board of Directors granted 80,000 375,200 31,000 77,000 Pursuant to a review of the compensation of the senior management of the Company and managements’ performance in 2016, on February 24, 2017, the Board of Directors granted 125,000 700,000 58,000 175,000 Weighted Average Grant Date Shares Fair Value Non-vested, January 1, 2017 53,335 $ 4.69 Granted 125,000 5.60 Vested (68,332) 5.24 Non-vested, September 30, 2017 110,003 $ 5.38 Warrants: Number of Shares Warrant Exercise Warrant To be Purchased Price per Share Expiration Date 113,600 $ 3.750 June 21, 2018 110,000 $ 3.125 September 30, 2018 48,960 $ 7.500 March 11, 2019 717,000 $ 4.500 March 11, 2019 30,000 $ 9.900 January 14, 2020 1,019,560 In connection with its March 11, 2014 offering, the Company issued warrants to purchase 816,000 717,000 |
LONG-TERM DEBT, NET
LONG-TERM DEBT, NET | 9 Months Ended |
Sep. 30, 2017 | |
LONG-TERM DEBT, NET [Abstract] | |
LONG-TERM DEBT, NET | 5. LONG-TERM DEBT, NET Loan and Security Agreement: On June 30, 2016 (the ”Closing Date”), the Company and its wholly-owned subsidiary CytoSorbents Medical, Inc. (together, the “Borrower”), entered into a Loan and Security Agreement (the “Loan and Security Agreement”) with Bridge Bank, a division of Western Alliance Bank, (the “Bank”), pursuant to which the Bank agreed to loan up to an aggregate of $ 10 5 7.75 8.98 On the Closing Date, the Company was required to pay a non-refundable closing fee of $ 50,000 24,000 1,560 44,833 120,393 7,558 7,427 22,413 7,427 10.0 333,333 18,229 7,813 33,854 7,813 2.0 1.5 1.0 Events of default which may cause repayment of the Term Loans to be accelerated include, among other customary events of default, (1) non-payment of any obligation when due, (2) the failure to perform any obligation required under the Loan and Security Agreement and to cure such default within a reasonable time frame, (3) the occurrence of a Material Adverse Event (as defined in the Loan and Security Agreement), (4) the attachment or seizure of a material portion of the Borrower’s assets if such attachment or seizure is not released, discharged or rescinded within 10 days, and (5) if the Borrower becomes insolvent or starts an insolvency proceeding or if an insolvency proceeding is brought by a third party against the Borrower and such proceeding is not dismissed or stayed within 30 days. The Loan and Security Agreement includes customary loan conditions, Borrower representations and warranties, Borrower affirmative covenants and Borrower negative covenants for secured transactions of this type. Effective with the issuance of Term Loan B on June 30, 2017, the Company is required to meet a financial covenant which requires the Company to achieve consolidated trailing six month revenue from product sales equal to at least 75 The Borrower’s obligations under the Loan and Security Agreement are joint and severable, and are secured by a first priority security interest in favor of the Bank with respect to the Shares (as defined in the Loan and Security Agreement) and the Collateral (as defined in the Loan and Security Agreement, which definition excludes the Borrower’s intellectual property and other customary exceptions). Success Fee Letter: In connection with the Loan and Security Agreement, the Borrower simultaneously entered into a Success Fee Letter (the “Letter”) with the Bank. Pursuant to the Letter, the Borrower shall pay to the Bank a success fee in the amount equal to 6.37 8.00 If the Success Fee is due pursuant to a Liquidity Event described in clause (d) of the definition thereof, the Company may elect, in lieu of paying the Success Fee in cash, to issue and sell to the Bank, in exchange for the Success Fee, such number of shares of the Company’s Common Stock as would be equal to the quotient (calculated by rounding up the nearest whole number) obtained by dividing (a) the Success Fee by (b) the volume weighted average price per share of the Company’s Common Stock for the same five successive business days on which the closing price per share of the Company’s Common Stock caused the Success Fee to become payable. The Bank’s right to receive the Success Fee and the Borrower’s obligation to pay such Success Fee terminate on June 30, 2021, and shall survive the termination of the Loan and Security Agreement and any prepayment of the Term Loans. September 30, 2017 December 31, 2016 Principal amount $ 10,000,000 $ 5,000,000 Less unamortized debt acquisition costs (83,124) (103,978) Plus accrued final fee 49,479 15,625 Subtotal 9,966,355 4,911,647 Less Current maturities 3,000,000 833,333 Long-term debt net of current maturities $ 6,966,355 $ 4,078,314 2018 $ 3,000,000 2019 4,000,000 2020 3,000,000 Total $ 10,000,000 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 9 Months Ended |
Sep. 30, 2017 | |
COMMITMENTS AND CONTINGENCIES [Abstract] | |
COMMITMENTS AND CONTINGENCIES | COMMITMENTS AND CONTINGENCIES Employment Agreements On July 14, 2015, CytoSorbents Corporation entered into executive employment agreements with its principal executives, Dr. Phillip P. Chan, President and Chief Executive Officer, Vincent Capponi, Chief Operating Officer, and Kathleen P. Bloch, Chief Financial Officer. Each of these agreements has an initial term of three years, and is retroactively effective as of January 1, 2015. On May 30, 2017, CytoSorbents Corporation announced the appointment of Dr. Eric R. Mortensen as the Company’s Chief Medical Officer, pursuant to the terms of an employment agreement dated May 23, 2017. Dr. Mortensen’s employment agreement provides for an initial term commencing on June 1, 2017 and ending on December 31, 2019. These employment agreements each provide for base salary and other customary benefits which include participation in group insurance plans, paid time off and reimbursement of certain business related expenses, including travel and continuing educational expenses, as well as bonus and/or equity awards at the discretion of the Board of Directors. In addition, the agreements provide for certain termination benefits in the event of termination without Cause or voluntary termination of employment for “Good Reason”, as defined in each agreement. The agreements also provide for certain benefits in the event of a Change in Control of the Company, as defined in each agreement. Litigation The Company is from time to time subject to claims and litigation arising out of the ordinary course of business. The Company intends to defend vigorously against any future claims and litigation. The Company is not currently a party to any legal proceedings. Royalty Agreements Pursuant to an agreement dated August 11, 2003, an existing investor agreed to make a $ 4 3 101,000 63,000 267,000 165,000 License Agreements In August 2006, the Company entered into a license agreement which provides the Company the exclusive right to use its patented technology and proprietary know how relating to adsorbent polymers for a period of 18 years, which expires on August 7, 2024. Under the terms of the agreement, the Company has agreed to pay royalties of 2.5 5 18 169,000 84,000 446,000 220,000 |
NET LOSS PER SHARE
NET LOSS PER SHARE | 9 Months Ended |
Sep. 30, 2017 | |
NET LOSS PER SHARE [Abstract] | |
NET LOSS PER SHARE | NET LOSS PER SHARE Basic loss per share and diluted loss per share for the three and nine months ended September 30, 2017 and 2016 have been computed by dividing the net loss for each respective period by the weighted average number of shares outstanding during that period. All outstanding warrants, options and restricted stock awards representing approximately 4,948,750 4,058,557 |
SUBSEQUENT EVENT
SUBSEQUENT EVENT | 9 Months Ended |
Sep. 30, 2017 | |
SUBSEQUENT EVENT [Abstract] | |
SUBSEQUENT EVENTS | 8. SUBSEQUENT EVENT From October 1, 2017 through November 7, 2017, the Company sold 157,398 SM 980,000 2,863,000 |
PRINCIPAL BUSINESS ACTIVITY A15
PRINCIPAL BUSINESS ACTIVITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 9 Months Ended |
Sep. 30, 2017 | |
PRINCIPAL BUSINESS ACTIVITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES [Abstract] | |
Nature of Business | Nature of Business The Company is a leader in critical care immunotherapy, investigating and commercializing its CytoSorb blood purification therapy to reduce deadly uncontrolled inflammation in hospitalized patients around the world, with the goal of preventing or treating multiple organ failure in life-threatening illnesses. The Company, through its subsidiary CytoSorbents Medical Inc. (formerly known as CytoSorbents, Inc.), is engaged in the research, development and commercialization of medical devices with its blood purification technology platform which incorporates a proprietary adsorbent, porous polymer technology. The Company, through its subsidiary, CytoSorbents Europe GmbH, conducts sales and marketing related operations for the CytoSorb device. In March 2016, the Company formed CytoSorbents Switzerland GmbH, a wholly-owned subsidiary of CytoSorbents Europe GmbH. This subsidiary, which began operations during the second quarter of 2016, provides marketing and direct sales services in Switzerland. CytoSorb , The technology is based upon biocompatible, highly porous polymer sorbent beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface absorption. The Company has numerous products under development based upon this unique blood purification technology, which include HemoDefend, ContrastSorb, DrugSorb, and others. As of September 30, 2017, the Company owns 32 issued United States patents and has multiple issued patents and pending patent applications worldwide. Our patent portfolio includes 16 issued United States patents as well as multiple issued patents and pending patent applications directed to various compositions and methods of use related to our blood purifications technologies, which are expected to expire between 2018 and 2031, absent any patent term extensions. Management believes that any expiring patents will not have a significant impact on our ongoing business. |
Stock Market Listing | Stock Market Listing On December 17, 2014 the Company’s common stock, par value $ 0.001 |
Basis of Consolidation and Foreign Currency Translation | Basis of Consolidation and Foreign Currency Translation The consolidated financial statements include the accounts of the parent, CytoSorbents Corporation, and its wholly-owned subsidiaries, CytoSorbents Medical, Inc. and CytoSorbents Europe GmbH. In addition, the financial statements include CytoSorbents Switzerland GmbH, a wholly owned subsidiary of CytoSorbents Europe GmbH. All significant intercompany transactions and balances have been eliminated in consolidation. Translation gains and losses resulting from the process of remeasuring into the U.S. dollar, the foreign currency financial statements of CytoSorbents Europe GmbH, for which the U.S. dollar is the functional currency, are included in operations. Foreign currency transaction gain amounted to $ 348,546 73,445 1,221,334 176,096 |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. |
Grants and Accounts Receivable | Grants and Accounts Receivable Grants receivable represent amounts due from U.S. government agencies and are included in Grants and Accounts Receivable. Accounts receivable are unsecured, non-interest bearing customer obligations due under normal trade terms. The Company sells its devices to various hospitals and distributors. The Company performs ongoing credit evaluations of customers’ financial condition. Management reviews accounts receivable periodically to determine collectability. Balances that are determined to be uncollectible are written off to the allowance for doubtful accounts. The allowance for doubtful accounts contains a general accrual for estimated bad debts and amounted to approximately $ 77,000 65,000 |
Inventories | Inventories Inventories are valued at the lower of cost or market. At September 30, 2017 and December 31, 2016, the Company’s inventory was comprised of finished goods, which amounted to $ 351,642 307,483 648,131 467,663 89,570 58,830 |
Property and Equipment | Property and Equipment Property and equipment are recorded at cost less accumulated depreciation. Depreciation of property and equipment is provided for by the straight-line method over the estimated useful lives of the related assets. Leasehold improvements are amortized over the lesser of their economic useful lives or the term of the related leases. Gains and losses on depreciable assets retired or sold are recognized in the statements of operations in the year of disposal. Repairs and maintenance expenditures are expensed as incurred. |
Patents | Patents Legal costs incurred to establish and successfully defend patents are capitalized. When patents are issued, capitalized costs are amortized on the straight-line method over the related patent term. In the event a patent is abandoned, the net book value of the patent is written off. |
Impairment or Disposal of Long-Lived Assets | Impairment or Disposal of Long-Lived Assets The Company assesses the impairment of patents and other long-lived assets under accounting standards for the impairment or disposal of long-lived assets whenever events or changes in circumstances indicate that the carrying value may not be recoverable. For long-lived assets to be held and used, the Company recognizes an impairment loss only if its carrying amount is not recoverable through its undiscounted cash flows and measures the impairment loss based on the difference between the carrying amount and fair value. |
Warrant Liability | Warrants (See Note 3) The Company recognizes the fair value of the warrants with a down round feature as a component of stockholders’ equity as of the date of the warrant grant. When the down round feature is triggered, the Company remeasures the fair value of the warrants, and records the change in fair value as a dividend and as a reduction in net income available to common stockholders. |
Revenue Recognition | Revenue Recognition Product Sales : Revenues from sales of products are recognized at the time when title and risk of loss passes to the customer. Recognition of revenue also requires reasonable assurance of collection of sales proceeds and completion of all performance obligations. Grant Revenue : Revenue from grant income is based on contractual agreements. Certain agreements provide for reimbursement of costs, while other agreements provide for reimbursement of costs and an overhead margin. Revenues are recognized when milestones have been achieved and revenues have been earned. Costs are recorded as incurred. Costs subject to reimbursement by these grants have been reflected as costs of revenue. |
Research and Development | Research and Development All research and development costs, payments to laboratories and research consultants and costs of clinical trials and studies are expensed when incurred. |
Advertising Expenses | Advertising Expenses Advertising expenses are charged to activities when incurred. Advertising expenses amounted to approximately $ 45,000 28,000 132,000 153,000 |
Income Taxes | Income Taxes Income taxes are accounted for under the asset and liability method prescribed by accounting standards for accounting for income taxes. Deferred income taxes are recorded for temporary differences between financial statement carrying amounts and the tax basis of assets and liabilities. Deferred tax assets and liabilities reflect the tax rates expected to be in effect for the years in which the differences are expected to reverse. A valuation allowance is provided if it is more likely than not that some or all of the deferred tax asset will not be realized. Under Section 382 of the Internal Revenue Code, the net operating losses generated prior to the previously completed reverse merger may be limited due to the change in ownership. Additionally, net operating losses generated subsequent to the reverse merger may be limited in the event of changes in ownership. The Company follows accounting standards associated with uncertain tax positions. The Company had no unrecognized tax benefits at September 30, 2017 or December 31, 2016. The Company files tax returns in the U.S. federal and various state jurisdictions. The Company utilizes the Technology Business Tax Certificate Transfer Program to sell a portion of its New Jersey Net Operating Loss carry forwards to an industrial company. Each of CytoSorbents Europe GmbH and CytoSorbents Switzerland GmbH files an annual corporate tax return, VAT return and a trade tax return in Germany and Switzerland, respectively. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities. Actual results could differ from these estimates. Significant estimates in these financials are the valuation of options granted, and valuation methods used to determine the fair value of the warrant liability. |
Concentration of Credit Risk | Concentration of Credit Risk The Company maintains cash balances, at times, with financial institutions in excess of amounts insured by the Federal Deposit Insurance Corporation. Management monitors the soundness of these institutions in an effort to minimize its collection risk of these balances. A significant portion of our revenues are from product sales in Germany. Substantially all of our grant and other income are from grant agencies in the United States. Three Months Ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 Product Sales: Germany $ 1,964,434 $ 1,327,193 $ 5,359,560 $ 3,653,995 All other countries 1,484,227 815,923 3,726,246 1,939,240 Grant and other income: United States 375,638 268,592 1,418,237 850,993 Total revenue $ 3,824,299 $ 2,411,708 $ 10,504,043 $ 6,444,228 As of September 30, 2017, two distributors accounted for approximately 33 22 10 11 10 11 |
Financial Instruments | Financial Instruments The carrying values of cash and cash equivalents, short-term investments, accounts payable, notes payable, and other debt obligations approximate their fair values due to their short-term nature. |
Net Loss Per Common Share | Net Loss Per Common Share Basic earnings per share is computed by dividing loss available to common stockholders by the weighted average number of common shares outstanding during the period. Diluted earnings per common share is computed using the treasury stock method on the basis of the weighted-average number of shares of Common Stock plus the dilutive effect of potential common shares outstanding during the period. Dilutive potential common shares include outstanding warrants, stock options and restricted shares. The computation of diluted earnings per share does not assume conversion, exercise or contingent exercise of securities that would have an anti-dilutive effect on earnings (See Note 7). |
Stock-Based Compensation | Stock-Based Compensation The Company accounts for its stock-based compensation under the recognition requirements of accounting standards for accounting for stock-based compensation, for employees and directors whereby each option granted is valued at fair market value on the date of grant. Under these accounting standards, the fair value of each option is estimated on the date of grant using the Black-Scholes option pricing model. The Company also follows the guidance of accounting standards for accounting for equity instruments that are issued to other than employees for acquiring, or in conjunction with selling, goods or services for equity instruments issued to consultants. |
Effects of Recent Accounting Pronouncements | Effects of Recent Accounting Pronouncements In May 2014, the FASB issued ASU 2014-09, “Revenue with Contracts from Customers.” ASU 2014-09 supersedes the current revenue recognition guidance, including industry-specific guidance. The ASU introduces a five-step model to achieve its core principal of the entity recognizing revenue to depict the transfer of goods or services to customers at an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods and services. In August 2014, the FASB issued ASU 2015-14 which deferred the effective date by one year. Accordingly, the updated guidance is effective for public entities for interim and annual periods beginning after December 15, 2017 and early adoption is permitted as of the beginning of an interim or annual reporting period beginning after December 31, 2016. In 2016, the FASB issued ASU’s 2016-08, 2016-10 and 2016-12, all of which relate to this same topic and have the same effective date. The Company has evaluated the impact of these ASU’s and has determined that the adoption of this updated guidance may result in the deferral of revenue for certain distributors and strategic partners due to volume pricing discounts in the contracts. Also, revenues may be deferred on certain grant contracts with government agencies. The Company may also be required to capitalize costs incurred to obtain certain grant contracts and amortize these costs over the term of the related contract. Adoption of these ASU’s may require enhanced disclosures regarding contracts with customers including disaggregation of revenue, information about contract balances and performance obligations, significant judgments used in determining transaction price and assets recognized from costs to obtain a contract. In July 2015, the FASB issued ASU 2015-11, “Inventory: Simplifying the Measurement of Inventory.” ASU 2015-11 clarifies current guidance regarding the valuation of inventory. ASU 2015-11 requires that inventory be measured at the lower of cost or net realizable value. This ASU does not apply to inventory that is measured using the last-in, first-out (“LIFO”) or the retail inventory method. The updated guidance is effective for public entities for fiscal years beginning after December 15, 2016, and interim periods within fiscal years beginning after December 15, 2017. The Company has evaluated the impact of the updated guidance and has determined that the adoption of ASU 2015-11 is not expected to have a significant impact on its consolidated financial statements. In February 2016, the FASB issued ASU 2016-02, “Leases (Topic 842)”. ASU 2016-02 outlines reporting requirements for Lessees to recognize a right-of-use asset and corresponding liability on the balance sheet for all leases covering a period of greater than 12 months. The liability is to be measured as the present value of the future minimum lease payments, plus any initial direct costs. The minimum payments are discounted using the rate implicit in the lease, or, if not known, the lessee’s incremental borrowing rate. The updated guidance is effective for public entities for fiscal years beginning after December 31, 2018. The Company is evaluating the impact of the updated guidance and has determined that the adoption of ASU 2016-02 may impact certain financial statement disclosures, particularly with regard to leases of premises. In August 2016, the FASB issued ASU 2016-15, “Statement of Cash Flows Classification of Certain Cash Receipts and Cash Payments (a consensus of the Emerging Issues Task Force).” The amendments in this Update relate to eight specific types of cash receipts and cash payments which current GAAP either is unclear or does not include specific guidance on the cash flow classification issues. The amendments in this Update are effective for public business entities for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. Early adoption is permitted, including adoption in an interim period. If an entity early adopts the amendments in an interim period, any adjustments should be reflected as of the beginning of the fiscal year that includes that interim period. An entity that elects early adoption must adopt all of the amendments in the same period. The Company will adopt the provisions of this ASU for its fiscal year beginning January 1, 2018. The adoption of ASU 2016-15 is not expected to have a significant impact on its consolidated financial statements. In May 2017, the FASB issued ASU 2017-09, “Compensation – Stock Compensation (Topic 718). The amendments in this Update provide guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting in Topic 718. The amendments in this Update are effective for all entities for annual periods, and interim periods within those annual periods, beginning after December 15, 2017. Early adoption is permitted, including adoption in any interim period, for (1) public business entities for reporting periods for which financial statements have not yet been issued and (2) all other entities for reporting periods for which financial statements have not yet been made available for issuance. The amendments in this Update should be applied prospectively to an award modified on or after the adoption date. The Company is evaluating the impact of the revised guidance and believes that this will not have a significant impact on its consolidated financial statements. In July 2017, the FASB issued ASU 2017-11, “Earning Per Share (Topic 260); Distinguishing Liabilities from Equity (Topic 480); Derivatives and Hedging (Topic 815). Part I of this Update addresses the complexity of accounting for certain financial instruments with down round features. The amendments in Part I of this Update change the classification analysis of certain equity-linked financial instruments (or embedded features) with down round features. When determining whether certain financial instruments should be classified as liabilities or equity instruments, a down round feature no longer precludes equity classification when assessing whether the instrument is indexed to an entity’s own stock. The amendments also clarify existing disclosure requirements for equity-classified instruments. For public business entities, the amendments in Part I of this Update are effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018. For all other entities, the amendments in Part I of this Update are effective for fiscal years beginning after December 15, 2019, and interim periods within fiscal years beginning after December 15, 2020. Early adoption is permitted for all entities, including adoption in an interim period. If an entity early adopts the amendments in an interim period, any adjustments should be reflected as of the beginning of the fiscal year that includes that interim period. The Company has elected to adopt the provisions of this ASU as of September 30, 2017 and has restated its current and comparative financial statements within this quarterly filing accordingly. (See Note 3). |
Shipping and Handling Costs | Shipping and Handling Costs The cost of shipping product to customers and distributors is typically borne by the customer or distributor. The Company records other shipping and handling costs in Research and Development. Total freight costs amounted to approximately $ 50,000 28,000 178,000 99,000 |
PRINCIPAL BUSINESS ACTIVITY A16
PRINCIPAL BUSINESS ACTIVITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
PRINCIPAL BUSINESS ACTIVITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES [Abstract] | |
Geographic summary of revenues | The following table provides a geographic summary of revenues for the three and nine months ended September 30, 2017 and 2016: Three Months Ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 Product Sales: Germany $ 1,964,434 $ 1,327,193 $ 5,359,560 $ 3,653,995 All other countries 1,484,227 815,923 3,726,246 1,939,240 Grant and other income: United States 375,638 268,592 1,418,237 850,993 Total revenue $ 3,824,299 $ 2,411,708 $ 10,504,043 $ 6,444,228 |
STOCKHOLDERS' EQUITY (Tables)
STOCKHOLDERS' EQUITY (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
STOCKHOLDERS' EQUITY [Abstract] | |
Schedule Of Share Based Compensation Stock Options Activity | The summary of the stock option activity for the nine months ended September 30, 2017 is as follows: Weighted Weighted Average Average Remaining Exercise Price Contractual Shares per Share Life (Years) Outstanding, December 31, 2016 2,762,177 $ 4.69 6.0 Granted 1,180,950 5.45 9.7 Forfeited (17,640) 4.65 — Expired (32,120) 36.33 — Exercised (74,180) 3.56 — Outstanding, September 30, 2017 3,819,187 $ 4.68 6.8 |
Schedule of Share-based Compensation, Shares Authorized under Stock Option Plans, by Exercise Price Range | The aggregate intrinsic value is calculated at the difference between the market value as of September 30, 2017 of $6.20 and the exercise price of the shares. Options Outstanding Number Weighted Weighted Range of Outstanding at Average Average Aggregate Exercise September 30, Exercise Remaining Intrinsic Price 2017 Price Life (Years) Value $0.88 - $11.48 3,819,187 $ 4.68 6.8 $ 6,045,932 Options Exercisable Number Weighted Exercisable at Average Aggregate September 30, Exercise Intrinsic 2017 Price Value 2,592,062 $ 4.31 $ 5,125,994 |
Schedule Of Nonvested Share Activity | The summary of the status of the Company’s non-vested options for the nine months ended September 30, 2017 is as follows: Weighted Average Grant Date Shares Fair Value Non-vested, January 1, 2017 912,547 $ 2.55 Granted 1,180,950 0.58 Forfeited (1,000) 2.41 Vested (865,372) 2.36 Non-vested, September 30, 2017 1,227,125 $ 0.62 |
Schedule Of Restricted Stock Unit Activity | The following table outlines the restricted stock unit activity for the nine months ended September 30, 2017: Weighted Average Grant Date Shares Fair Value Non-vested, January 1, 2017 53,335 $ 4.69 Granted 125,000 5.60 Vested (68,332) 5.24 Non-vested, September 30, 2017 110,003 $ 5.38 |
Schedule Of Stockholders Equity Note Warrants and Common Stock Activity | As of September 30, 2017, the Company has the following warrants to purchase Common Stock outstanding: Number of Shares Warrant Exercise Warrant To be Purchased Price per Share Expiration Date 113,600 $ 3.750 June 21, 2018 110,000 $ 3.125 September 30, 2018 48,960 $ 7.500 March 11, 2019 717,000 $ 4.500 March 11, 2019 30,000 $ 9.900 January 14, 2020 1,019,560 |
LONG-TERM DEBT, NET (Tables)
LONG-TERM DEBT, NET (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
LONG-TERM DEBT, NET [Abstract] | |
Schedule of Long-term Debt | Long-term debt consists of the following at September 30, 2017: September 30, 2017 December 31, 2016 Principal amount $ 10,000,000 $ 5,000,000 Less unamortized debt acquisition costs (83,124) (103,978) Plus accrued final fee 49,479 15,625 Subtotal 9,966,355 4,911,647 Less Current maturities 3,000,000 833,333 Long-term debt net of current maturities $ 6,966,355 $ 4,078,314 |
Schedule of Principal payments of long-term debt | Annual principal payments of long-term debt are as follows at September 30,: 2018 $ 3,000,000 2019 4,000,000 2020 3,000,000 Total $ 10,000,000 |
BASIS OF PRESENTATION (Details
BASIS OF PRESENTATION (Details Textual) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2016 | |
BASIS OF PRESENTATION [Line Items] | |||||
Accumulated deficit | $ (149,165,617) | $ (149,165,617) | $ (143,516,106) | ||
Net income (loss) | $ (2,054,279) | $ (2,188,119) | $ (5,313,780) | $ (6,857,445) |
PRINCIPAL BUSINESS ACTIVITY A20
PRINCIPAL BUSINESS ACTIVITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Product Sales: | ||||
Sales Revenue, Goods, Net | $ 3,448,661 | $ 2,143,116 | $ 9,085,806 | $ 5,593,235 |
Grant and other income: | ||||
Total Revenue | 3,824,299 | 2,411,708 | 10,504,043 | 6,444,228 |
United States [Member] | ||||
Grant and other income: | ||||
Other Revenue, Net | 375,638 | 268,592 | 1,418,237 | 850,993 |
Germany [Member] | ||||
Product Sales: | ||||
Sales Revenue, Goods, Net | 1,964,434 | 1,327,193 | 5,359,560 | 3,653,995 |
All other countries [Member] | ||||
Product Sales: | ||||
Sales Revenue, Goods, Net | $ 1,484,227 | $ 815,923 | $ 3,726,246 | $ 1,939,240 |
PRINCIPAL BUSINESS ACTIVITY A21
PRINCIPAL BUSINESS ACTIVITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Textual) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2016 | Dec. 17, 2014 | |
Principal Business Activity and Summary of Significant Accounting Policies [Line Items] | ||||||
Common Stock, Par Value | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | ||
Foreign Currency Transaction Gain (Loss), before Tax | $ 348,546 | $ 73,445 | $ 1,221,334 | $ 176,096 | ||
Allowance For Doubtful Accounts Receivable | 76,601 | 76,601 | $ 65,414 | |||
Inventory, Finished Goods, Gross | 351,642 | 351,642 | 307,483 | |||
Inventory, Work in Process, Gross | 648,131 | 648,131 | 467,663 | |||
Inventory, Raw Materials, Gross | 89,570 | 89,570 | $ 58,830 | |||
Advertising Expense | 45,000 | 28,000 | 132,000 | 153,000 | ||
Freight Costs | $ 50,000 | $ 28,000 | $ 178,000 | $ 99,000 | ||
Accounts Receivable [Member] | Two Distributors and One Government Agency [Member] | ||||||
Principal Business Activity and Summary of Significant Accounting Policies [Line Items] | ||||||
Concentration Risk, Percentage | 33.00% | |||||
Accounts Receivable [Member] | Three Distributors [Member] | ||||||
Principal Business Activity and Summary of Significant Accounting Policies [Line Items] | ||||||
Concentration Risk, Percentage | 22.00% | |||||
Sales Revenue, Goods, Net [Member] | ||||||
Principal Business Activity and Summary of Significant Accounting Policies [Line Items] | ||||||
Concentration Risk, Percentage | 10.00% | 11.00% | 10.00% | 11.00% |
ADOPTION OF NEW ACCOUNTING ST22
ADOPTION OF NEW ACCOUNTING STANDARD AND RESTATEMENT (Details Textual) - USD ($) | Mar. 11, 2014 | Jan. 31, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2016 |
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 816,000 | ||||||
Fair Value Warrant Liability | $ 862,920 | $ 1,636,128 | |||||
Share Price | $ 4.50 | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 4.50 | $ 4.50 | $ 4.50 | ||||
New Accounting Pronouncement or Change in Accounting Principle, Effect of Change on Net Income | $ 494,596 | $ 765,106 | $ 666,815 | ||||
Preferred Stock Dividends and Other Adjustments | $ 0 | $ 0 | $ 335,731 | $ 0 | |||
Restatement Adjustment [Member] | |||||||
Cumulative Effect of New Accounting Principle in Period of Adoption | $ 1,811,547 | ||||||
Retained Earnings [Member] | |||||||
New Accounting Pronouncement or Change in Accounting Principle, Cumulative Effect of Change on Equity or Net Assets | 773,208 | ||||||
Retained Earnings [Member] | Restatement Adjustment [Member] | |||||||
Cumulative Effect of New Accounting Principle in Period of Adoption | 948,627 | ||||||
Additional Paid-in Capital [Member] | |||||||
New Accounting Pronouncement or Change in Accounting Principle, Cumulative Effect of Change on Equity or Net Assets | $ 862,920 | ||||||
Additional Paid-in Capital [Member] | Restatement Adjustment [Member] | |||||||
Cumulative Effect of New Accounting Principle in Period of Adoption | $ 862,920 |
STOCKHOLDERS' EQUITY (Details)
STOCKHOLDERS' EQUITY (Details) | 9 Months Ended |
Sep. 30, 2017$ / sharesshares | |
Shares | |
Outstanding | shares | 2,762,177 |
Granted | shares | 1,180,950 |
Forfeited | shares | (17,640) |
Expired | shares | (32,120) |
Exercised | shares | (74,180) |
Outstanding | shares | 3,819,187 |
Weighted Average Exercise Price per Share | |
Outstanding | $ / shares | $ 4.69 |
Granted | $ / shares | 5.45 |
Forfeited | $ / shares | 4.65 |
Expired | $ / shares | 36.33 |
Exercised | $ / shares | 3.56 |
Outstanding | $ / shares | $ 4.68 |
Weighted Average Remaining Contractual Life (Years) | |
Outstanding | 6 years |
Granted | 9 years 8 months 12 days |
Forfeited | 0 years |
Expired | 0 years |
Exercised | 0 years |
Exercisable | 6 years 9 months 18 days |
STOCKHOLDERS' EQUITY (Details 1
STOCKHOLDERS' EQUITY (Details 1) | 9 Months Ended |
Sep. 30, 2017USD ($)$ / sharesshares | |
Options Outstanding | |
Number Outstanding at September 30, 2017 | shares | 3,819,187 |
Weighted Average Exercise Price | $ 4.68 |
Weighted Average Remaining Life (Years) | 6 years 9 months 18 days |
Aggregate Intrinsic Value | $ | $ 6,045,932 |
Options Exercisable | |
Number Exercisable at September 30, 2017 | shares | 2,592,062 |
Weighted Average Exercise Price | $ 4.31 |
Aggregate Intrinsic Value | $ | $ 5,125,994 |
$0.88 - $11.48 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Range of Exercise Price, Lower Range Limit | $ 0.88 |
Range of Exercise Price, Upper Range Limit | $ 11.48 |
STOCKHOLDERS' EQUITY (Details 2
STOCKHOLDERS' EQUITY (Details 2) | 9 Months Ended |
Sep. 30, 2017$ / sharesshares | |
Shares | |
Non-vested, January 1, 2017 | shares | 912,547 |
Granted | shares | 1,180,950 |
Forfeited | shares | (1,000) |
Vested | shares | (865,372) |
Non-vested, September 30, 2017 | shares | 1,227,125 |
Weighted Average Grant Date Fair Value | |
Non-vested, January 1, 2017 | $ / shares | $ 2.55 |
Granted | $ / shares | 0.58 |
Forfeited | $ / shares | 2.41 |
Vested | $ / shares | 2.36 |
Non-vested, September 30, 2017 | $ / shares | $ 0.62 |
STOCKHOLDERS' EQUITY (Details 3
STOCKHOLDERS' EQUITY (Details 3) - Restricted Stock Units (RSUs) [Member] | 9 Months Ended |
Sep. 30, 2017$ / sharesshares | |
Shares | |
Non-vested, January 1, 2017 | shares | 53,335 |
Granted | shares | 125,000 |
Vested | shares | (68,332) |
Non-vested, September 30, 2017 | shares | 110,003 |
Weighted Average Grant Date Fair Value | |
Non-vested, January 1, 2017 | $ / shares | $ 4.69 |
Granted | $ / shares | 5.6 |
Vested | $ / shares | 5.24 |
Non-vested, September 30, 2017 | $ / shares | $ 5.38 |
STOCKHOLDERS' EQUITY (Details 4
STOCKHOLDERS' EQUITY (Details 4) - $ / shares | 9 Months Ended | |
Sep. 30, 2017 | Mar. 11, 2014 | |
Class of Warrant or Right [Line Items] | ||
Number of Shares To be Purchased | 1,019,560 | |
Warrant Exercise Price per Share | $ 4.50 | $ 4.50 |
Warrant 1 | ||
Class of Warrant or Right [Line Items] | ||
Number of Shares To be Purchased | 113,600 | |
Warrant Exercise Price per Share | $ 3.750 | |
Warrant Expiration Date | Jun. 21, 2018 | |
Warrant 2 | ||
Class of Warrant or Right [Line Items] | ||
Number of Shares To be Purchased | 110,000 | |
Warrant Exercise Price per Share | $ 3.125 | |
Warrant Expiration Date | Sep. 30, 2018 | |
Warrant 3 | ||
Class of Warrant or Right [Line Items] | ||
Number of Shares To be Purchased | 48,960 | |
Warrant Exercise Price per Share | $ 7.500 | |
Warrant Expiration Date | Mar. 11, 2019 | |
Warrant 4 | ||
Class of Warrant or Right [Line Items] | ||
Number of Shares To be Purchased | 717,000 | |
Warrant Exercise Price per Share | $ 4.500 | |
Warrant Expiration Date | Mar. 11, 2019 | |
Warrant 5 | ||
Class of Warrant or Right [Line Items] | ||
Number of Shares To be Purchased | 30,000 | |
Warrant Exercise Price per Share | $ 9.900 | |
Warrant Expiration Date | Jan. 14, 2020 |
STOCKHOLDERS' EQUITY (Details T
STOCKHOLDERS' EQUITY (Details Textual) - USD ($) | Apr. 05, 2017 | Jun. 07, 2016 | Nov. 04, 2015 | Nov. 07, 2017 | Apr. 30, 2017 | Feb. 28, 2017 | Feb. 24, 2017 | Jun. 30, 2016 | Apr. 30, 2015 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2015 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2016 | Jul. 29, 2015 | Dec. 31, 2014 | Mar. 11, 2014 |
Stockholders Equity [Line Items] | ||||||||||||||||||
Preferred Stock, Shares Authorized | 5,000,000 | 5,000,000 | 5,000,000 | |||||||||||||||
Stock Issued During Period Shares New Issues | 282,394 | 28,880 | ||||||||||||||||
Stock Issued During Period Value New Issues | $ 1,659,000 | $ 225,000 | $ 11,971,463 | |||||||||||||||
Proceeds From Issuance Of Common Stock | 10,300,000 | |||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 816,000 | |||||||||||||||||
Aggregate registered amount for offerings | $ 100,000,000 | |||||||||||||||||
Allocated Share-based Compensation Expense | 960,000 | $ 124,000 | $ 1,851,000 | $ 599,000 | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Dividend Rate | 0.00% | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Risk Free Interest Rate, Minimum | 1.24% | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Risk Free Interest Rate, Maximum | 1.85% | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Non-vested in Period, Fair Value | $ 3,284,000 | |||||||||||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options | $ 470,000 | 470,000 | ||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Shares Issued in Period | 953,200 | |||||||||||||||||
Stock Issued During Period, Value, Restricted Stock Award, Net of Forfeitures, Total | $ 207,608 | |||||||||||||||||
Class Of Warrant Or Right, Outstanding | 1,019,560 | 1,019,560 | ||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 4.50 | $ 4.50 | $ 4.50 | |||||||||||||||
Stock or Unit Option Plan Expense | $ 821,000 | $ 1,478,000 | ||||||||||||||||
Preferred Stock Dividends and Other Adjustments | 0 | 0 | 335,731 | 0 | ||||||||||||||
Prepaid Expenses and Other Current Assets [Member] | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Escrow Deposit | $ 196,000 | 196,000 | ||||||||||||||||
Shelf Registration [Member] | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Proceeds From Issuance Of Common Stock | $ 10,000,000 | |||||||||||||||||
Over-Allotment Option [Member] | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Proceeds From Issuance Of Common Stock | $ 1,500,000 | |||||||||||||||||
Common Stock Including Additional Paid in Capital [Member] | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Stock Issued During Period Value New Issues | $ 11,500,000 | |||||||||||||||||
Common Stock Including Additional Paid in Capital [Member] | Shelf Registration [Member] | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Stock Issued During Period Shares New Issues | 2,222,222 | |||||||||||||||||
Shares Issued, Price Per Share | $ 4.50 | |||||||||||||||||
Common Stock Including Additional Paid in Capital [Member] | Over-Allotment Option [Member] | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Stock Issued During Period Shares New Issues | 333,333 | |||||||||||||||||
Warrant [Member] | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Class Of Warrant Or Right, Outstanding | 717,000 | 717,000 | ||||||||||||||||
Restricted Stock Units (RSUs) [Member] | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number | 1,668,500 | 1,539,000 | 110,003 | 110,003 | 53,335 | |||||||||||||
Stock Issued During Period, Shares, Restricted Stock Award, Gross | 80,000 | 125,000 | ||||||||||||||||
Stock Issued During Period, Value, Restricted Stock Award, Gross | $ 375,200 | $ 700,000 | ||||||||||||||||
Director [Member] | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Stock Issued During Period, Shares, Restricted Stock Award, Net of Forfeitures, Total | 240,000 | |||||||||||||||||
Stock Issued During Period, Value, Restricted Stock Award, Net of Forfeitures, Total | $ 725,200 | $ 1,936,000 | ||||||||||||||||
Employee [Member] | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Stock Issued During Period, Shares, Restricted Stock Award, Net of Forfeitures, Total | 129,500 | 414,000 | 960,000 | |||||||||||||||
Stock Issued During Period, Value, Restricted Stock Award, Net of Forfeitures, Total | $ 1,941,660 | $ 7,747,200 | ||||||||||||||||
Stock Issued During Period, Shares, Restricted Stock Award, Forfeited | 75,000 | |||||||||||||||||
Research and Development Expense [Member] | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Allocated Share-based Compensation Expense | $ 28,000 | 29,000 | $ 73,000 | 121,000 | ||||||||||||||
General and Administrative Expense [Member] | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Allocated Share-based Compensation Expense | 932,000 | $ 95,000 | $ 1,778,000 | $ 478,000 | ||||||||||||||
Cantor Fitzgerald and Co. [Member] | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Commission Rate As Percentage Of Aggregate Gross Proceeds | 3.00% | |||||||||||||||||
Maximum Amount To Be Reimbursed For Expenses In Connection With Agreement | $ 50,000 | |||||||||||||||||
Aggregate Offering Price Maximum | $ 25,000,000 | |||||||||||||||||
Maximum [Member] | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Volatility Rate | 80.80% | |||||||||||||||||
Maximum [Member] | Restricted Stock Units (RSUs) [Member] | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Stock Issued During Period, Value, Restricted Stock Award, Net of Forfeitures, Total | $ 175,000 | |||||||||||||||||
Minimum [Member] | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Volatility Rate | 66.80% | |||||||||||||||||
Minimum [Member] | Restricted Stock Units (RSUs) [Member] | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Stock Issued During Period, Value, Restricted Stock Award, Net of Forfeitures, Total | $ 58,000 | |||||||||||||||||
Stock Issued During Period, Shares, Restricted Stock Award, Forfeited | 31,000 | 77,000 | ||||||||||||||||
Series A Preferred Stock [Member] | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Preferred Stock, Shares Authorized | 5,000,000 | |||||||||||||||||
Exercise Price Ranging From 3.67 to 5.63 [Member] | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Term | 10 years | |||||||||||||||||
Exercise Price Ranging From 3.67 to 5.63 [Member] | Maximum [Member] | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Exercise Price | $ 6.20 | $ 6.20 | ||||||||||||||||
Exercise Price Ranging From 3.67 to 5.63 [Member] | Minimum [Member] | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Exercise Price | $ 3.45 | $ 3.45 | ||||||||||||||||
Subsequent Event [Member] | ||||||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||||||
Stock Issued During Period Shares New Issues | 157,398 | |||||||||||||||||
Stock Issued During Period Value New Issues | $ 980,000 | |||||||||||||||||
Sale of Stock, Price Per Share | $ 6.30 | |||||||||||||||||
Sale of Stock, Number of Shares Issued in Transaction | 468,672 | |||||||||||||||||
Sale of Stock, Consideration Received on Transaction | $ 2,863,000 |
LONG-TERM DEBT, NET (Details)
LONG-TERM DEBT, NET (Details) - USD ($) | Sep. 30, 2017 | Dec. 31, 2016 |
Principal amount | $ 10,000,000 | $ 5,000,000 |
Less unamortized debt acquisition costs | (83,124) | (103,978) |
Plus accrued final fee | 49,479 | 15,625 |
Subtotal | 9,966,355 | 4,911,647 |
Less Current maturities | 3,000,000 | 833,333 |
Long-term debt net of current maturities | $ 6,966,355 | $ 4,078,314 |
LONG-TERM DEBT, NET (Details 1)
LONG-TERM DEBT, NET (Details 1) | Sep. 30, 2017USD ($) |
2,018 | $ 3,000,000 |
2,019 | 4,000,000 |
2,020 | 3,000,000 |
Total | $ 10,000,000 |
LONG-TERM DEBT, NET (Details Te
LONG-TERM DEBT, NET (Details Textual) - USD ($) | 3 Months Ended | 6 Months Ended | 9 Months Ended | |||||
Sep. 30, 2017 | Sep. 30, 2016 | Jun. 30, 2017 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2016 | Jun. 30, 2016 | Mar. 11, 2014 | |
Debt Issuance Costs, Net | $ 83,124 | $ 83,124 | $ 103,978 | |||||
Share Price | $ 4.50 | |||||||
Term Loan Interest LIBRO Rate Adjusted Monthly | 7.75% | |||||||
Payments of Debt Issuance Costs | $ 1,560 | $ 118,833 | ||||||
Projected Revenue, Percentage | 75.00% | |||||||
Term A Loan [Member] | ||||||||
Debt Instrument, Interest Rate, Effective Percentage | 10.00% | |||||||
Non-Refundable Closing Fee [Member] | ||||||||
Interest Expense, Debt | 7,558 | $ 7,427 | 22,413 | 7,427 | ||||
Non-Refundable Final Fee [Member] | ||||||||
Interest Expense, Debt | $ 18,229 | $ 7,813 | $ 33,854 | $ 7,813 | ||||
Western Alliance Bank [Member] | ||||||||
Debt Instrument, Face Amount | $ 10,000,000 | |||||||
Debt Instrument, Interest Rate, Stated Percentage | 8.98% | 8.98% | ||||||
Debt Issuance Costs, Net | $ 120,393 | $ 120,393 | ||||||
Percentage Of Success fee | 6.37% | |||||||
Share Price | $ 8 | $ 8 | ||||||
Western Alliance Bank [Member] | First Anniversary [Member] | ||||||||
Debt Instrument, Periodic Payment | $ 333,333 | |||||||
Percentage Of Prepayment Interest | 2.00% | 2.00% | ||||||
Western Alliance Bank [Member] | Second Anniversary [Member] | ||||||||
Percentage Of Prepayment Interest | 1.50% | 1.50% | ||||||
Western Alliance Bank [Member] | Third Anniversary [Member] | ||||||||
Percentage Of Prepayment Interest | 1.00% | 1.00% | ||||||
Western Alliance Bank [Member] | Closing Fee [Member] | ||||||||
Debt Issuance Costs, Net | $ 50,000 | $ 50,000 | ||||||
Western Alliance Bank [Member] | Bank related Expenses [Member] | ||||||||
Debt Issuance Costs, Net | 24,000 | 24,000 | ||||||
Western Alliance Bank [Member] | Legal Expenses [Member] | ||||||||
Debt Issuance Costs, Net | $ 44,833 | $ 44,833 | ||||||
Western Alliance Bank [Member] | Term A Loan [Member] | ||||||||
Debt Instrument, Face Amount | $ 5,000,000 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details Textual) - USD ($) | Aug. 11, 2003 | Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 |
Commitments and Contingencies Disclosure [Line Items] | |||||
Term of License Agreement | 18 years | ||||
Royalty Agreements | |||||
Commitments and Contingencies Disclosure [Line Items] | |||||
Future royalty payment percentage on gross revenue | 3.00% | ||||
Royalty cost | $ 101,000 | $ 63,000 | $ 267,000 | $ 165,000 | |
Equity investment by an existing investor | $ 4,000,000 | ||||
License Agreement | |||||
Commitments and Contingencies Disclosure [Line Items] | |||||
Royalty rate, lower limit | 2.50% | 2.50% | |||
Royalty rate, upper limit | 5.00% | 5.00% | |||
Royalty cost | $ 169,000 | $ 84,000 | $ 446,000 | $ 220,000 |
NET LOSS PER SHARE (Details Tex
NET LOSS PER SHARE (Details Textual) - shares | 9 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Stock Options, Warrants And Restricted Stock Awards [Member] | ||
Earnings Per Share Basic [Line Items] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount | 4,948,750 | 4,058,557 |
SUBSEQUENT EVENT (Details Textu
SUBSEQUENT EVENT (Details Textual) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |
Nov. 07, 2017 | Sep. 30, 2017 | Dec. 31, 2015 | Sep. 30, 2017 | |
Subsequent Event [Line Items] | ||||
Stock Issued During Period, Shares, New Issues | 282,394 | 28,880 | ||
Stock Issued During Period, Value, New Issues | $ 1,659,000 | $ 225,000 | $ 11,971,463 | |
Subsequent Event [Member] | ||||
Subsequent Event [Line Items] | ||||
Stock Issued During Period, Shares, New Issues | 157,398 | |||
Stock Issued During Period, Value, New Issues | $ 980,000 | |||
Sale of Stock, Consideration Received on Transaction | $ 2,863,000 |