Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | May. 10, 2016 | Jun. 30, 2014 | |
Document And Entity Information | |||
Entity Registrant Name | EMMAUS LIFE SCIENCES, INC. | ||
Entity Central Index Key | 1,420,031 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2015 | ||
Trading Symbol | EMMA | ||
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 Public Float | $ 0 | ||
Entity Common Stock, Shares Outstanding | 28,563,478 | ||
Entity Common Stock, Par Value Per Share | $ 0.001 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2,015 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 |
CURRENT ASSETS | ||
Cash and cash equivalents | $ 472,341 | $ 556,318 |
Accounts receivable | 101,639 | 42,734 |
Inventories, net | $ 219,163 | 250,413 |
Marketable securities | $ 79,236 | |
Marketable securities, pledged to creditor | $ 219,015 | |
Prepaid expenses and other current assets | 131,113 | $ 129,554 |
Total current assets | 1,143,271 | 1,058,255 |
PROPERTY AND EQUIPMENT, net | $ 58,227 | 72,391 |
OTHER ASSETS | ||
Marketable securities, pledged to creditor | 334,410 | |
Intangibles, net | 892,857 | |
Deposits | $ 275,500 | 306,379 |
Total other assets | 275,500 | 1,533,646 |
Total Assets | 1,476,998 | 2,664,292 |
CURRENT LIABILITIES | ||
Accounts payable and accrued expenses | $ 3,780,494 | 2,601,420 |
Due to related party | $ 394,446 | |
Other current liability | $ 88,331 | |
Notes payable, net | 4,656,749 | $ 1,643,615 |
Notes payable to related parties, net | 2,766,304 | 825,562 |
Convertible notes payable, net | 6,000,347 | 3,456,959 |
Convertible notes payable to related parties, net | 298,000 | 373,000 |
Total current liabilities | 17,590,225 | 9,295,002 |
LONG-TERM LIABILITIES | ||
Deferred rent | $ 59,886 | 3,729 |
Liability classified warrants | 3,206,000 | |
Warrant derivative liabilities | $ 7,863,000 | 6,520,000 |
Notes payable, net | 833,335 | |
Notes payable to related parties, net | 133,333 | |
Convertible notes payable, net | 4,206,873 | 3,651,555 |
Convertible notes payable to related parties, net | 320,000 | 200,000 |
Total long-term liabilities | 12,449,759 | 14,547,952 |
Total Liabilities | $ 30,039,984 | $ 23,842,954 |
COMMITMENTS AND CONTINGENCIES | ||
STOCKHOLDERS' DEFICIT | ||
Preferred stock - par value $0.001 per share, 20,000,000 shares authorized, none issued and outstanding | ||
Common stock - par value $0.001 per share, 100,000,000 shares authorized, 28,163,478 and 30,511,573 shares issued and outstanding at December 31, 2015 and December 31, 2014, respectively | $ 28,163 | $ 30,512 |
Additional paid-in capital | 56,508,984 | 51,068,677 |
Accumulated other comprehensive loss | (318,324) | (194,015) |
Accumulated deficit | (84,781,809) | (72,083,836) |
Total Stockholders' Deficit | (28,562,986) | (21,178,662) |
Total Liabilities & Stockholders' Deficit | $ 1,476,998 | $ 2,664,292 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2015 | Dec. 31, 2014 |
Principal Outstanding, Current | ||
Preferred stock, par (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, authorized | 20,000,000 | 20,000,000 |
Common stock, par (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, authorized | 100,000,000 | 100,000,000 |
Common stock, issued | 28,163,478 | 30,511,573 |
Common stock, outstanding | 28,163,478 | 30,511,573 |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Income Statement [Abstract] | ||
REVENUES, Net | $ 590,114 | $ 500,679 |
COST OF GOODS SOLD | 286,687 | 267,040 |
GROSS PROFIT | 303,427 | 233,639 |
OPERATING EXPENSES | ||
Research and development | 1,579,112 | 1,966,254 |
Selling | 428,643 | 668,862 |
General and administrative | 9,419,683 | 12,555,266 |
Impairment of intangible assets | 678,571 | |
[OperatingExpenses] | 12,106,009 | 15,190,382 |
LOSS FROM OPERATIONS | (11,802,582) | $ (14,956,743) |
OTHER INCOME (EXPENSE) | ||
Realized gain on securities available-for-sale | (48,709) | |
Gain on derecognition of accounts payable and settlement of litigation | 418,366 | |
Change in fair value of liability classified warrants | 661,000 | $ (1,986,744) |
Change in fair value of warrant derivative liabilities | $ 1,202,000 | 548,000 |
Warrant exercise inducement expense | (3,523,000) | |
Interest and other income | $ 102,676 | 246,379 |
Interest expense | (3,227,160) | (2,082,541) |
[NonoperatingIncomeExpense] | (891,827) | (6,797,906) |
LOSS BEFORE INCOME TAXES | (12,694,409) | (21,754,649) |
INCOME TAXES | 3,564 | 3,665 |
NET LOSS | (12,697,973) | (21,758,314) |
COMPONENTS OF OTHER COMPREHENSIVE LOSS | ||
Unrealized holding loss on securities available-for-sale | (123,113) | (435,010) |
Unrealized foreign currency translation effect | (1,196) | (21,688) |
[OtherComprehensiveIncomeLossNetOfTaxPortionAttributableToParent] | (124,309) | (456,698) |
COMPREHENSIVE LOSS | $ (12,822,282) | $ (22,215,012) |
NET LOSS PER COMMON SHARE (in dollars per share) | $ (0.44) | $ (0.73) |
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING (in shares) | 28,958,580 | 29,846,962 |
CONSOLIDATED STATEMENT OF CHANG
CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS' DEFICIT - USD ($) | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Other Comprehensive Income (Loss) [Member] | Accumulated Deficit [Member] | Total |
Balance, beginning at Dec. 31, 2013 | $ 29,228 | $ 35,606,951 | $ 262,683 | $ (50,325,522) | $ (14,426,660) |
Balance, beginning (in shares) at Dec. 31, 2013 | 29,228,306 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Warrant issued in conjunction with convertible notes | 126,732 | 126,732 | |||
Beneficial conversion feature relating to convertible and promissory notes payable | 1,392,387 | 1,392,387 | |||
Proceeds from exercise of warrants | $ 1,255 | 4,276,380 | 4,277,635 | ||
Proceeds from exercise of warrants (in shares) | 1,254,621 | ||||
Share-based compensation | $ 6,521,812 | $ 6,521,812 | |||
Conversion of notes payable to common stock | 529 | 1,768,671 | 1,769,200 | ||
Conversion of notes payable to common stock (in shares) | $ 528,646 | ||||
Excess value of liability classified warrants upon exercise | $ 1,752,744 | $ 1,752,744 | |||
Common stock repurchased and cancelled | $ (500) | (377,000) | (377,500) | ||
Common stock repurchased and cancelled (in shares) | (500,000) | ||||
Unrealized loss on marketable securities, net of tax | (435,010) | (435,010) | |||
Foreign currency translation effect | (21,688) | (21,688) | |||
Net loss | (21,758,314) | (21,758,314) | |||
Balance, ending at Dec. 31, 2014 | $ 30,512 | 51,068,677 | (194,015) | (72,083,836) | (21,178,662) |
Balance, ending (in shares) at Dec. 31, 2014 | 30,511,573 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Warrant issued in conjunction with convertible notes | 220,071 | 220,071 | |||
Beneficial conversion feature relating to convertible and promissory notes payable | 1,388,201 | 1,388,201 | |||
Proceeds from exercise of warrants | $ 148 | 102,737 | 102,885 | ||
Proceeds from exercise of warrants (in shares) | 148,256 | ||||
Share-based compensation | $ 3,708,801 | $ 3,708,801 | |||
Conversion of notes payable to common stock | 5 | 17,995 | 18,000 | ||
Conversion of notes payable to common stock (in shares) | $ 5,898 | ||||
Exercise of common stock options (cashless) | $ 2 | $ (2) | |||
Exercise of common stock options (cashless) (in shares) | 2,000 | ||||
Common stock repurchased and cancelled | $ (2,504) | 2,504 | |||
Common stock repurchased and cancelled (in shares) | (2,504,249) | ||||
Unrealized loss on marketable securities, net of tax | (123,113) | $ (123,113) | |||
Foreign currency translation effect | (1,196) | (1,196) | |||
Net loss | (12,697,973) | (12,697,973) | |||
Balance, ending at Dec. 31, 2015 | $ 28,163 | $ 56,508,984 | $ (318,324) | $ (84,781,809) | $ (28,562,986) |
Balance, ending (in shares) at Dec. 31, 2015 | 28,163,478 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net loss | $ (12,697,973) | $ (21,758,314) |
Adjustments to reconcile net loss to net cash flows used in operating activities | ||
Depreciation and amortization | 233,179 | 230,906 |
Impairment of intangible assets | 678,571 | |
Interest expense accrued from discount of convertible notes | 1,597,064 | 897,353 |
Foreign exchange adjustments on convertible notes and notes payable | 474 | $ (157,494) |
Realized gain on marketable securities available-for-sale | 48,709 | |
Gain on settlement of litigation | (418,366) | |
Share-based compensation | $ 3,708,801 | $ 6,521,812 |
Warrant exercise inducement expense | 3,523,000 | |
Change in fair value of liability classified warrants | $ (661,000) | 1,986,744 |
Change in fair value of warrant derivative liabilities | (1,202,000) | (548,000) |
Net changes in operating assets and liabilities | ||
Accounts receivable | (58,904) | (9,259) |
Inventories | 31,251 | (19,233) |
Prepaid expenses and other current assets | (1,559) | (69,178) |
Deposits | 30,879 | (172,903) |
Accounts payable and accrued expenses | 1,607,203 | $ 835,012 |
Other current liability | 88,331 | |
Deferred rent | 56,157 | $ 4,075 |
Net cash flows used in operating activities | (6,959,183) | $ (8,735,479) |
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Proceeds from sales of investment securities available-for-sale | 46,728 | |
Purchases of property and equipment | (4,731) | $ (64,192) |
Net cash flows from (used in) investing activities | 41,997 | (64,192) |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Proceeds from notes payable issued | 4,235,566 | 400,000 |
Proceeds from convertible notes payable issued | $ 3,024,558 | 1,720,000 |
Due to dissenters | (125,000) | |
Repurchase of common stock | $ (377,500) | |
Payments of notes payable | $ (250,000) | |
Payments of convertible notes payable | (279,800) | $ (174,300) |
Proceeds from exercise of warrants | 102,885 | 4,277,635 |
Net cash flows from financing activities | $ 6,833,209 | 5,720,835 |
Effect of exchange rate changes on cash | (3,446) | |
Net decrease in cash and cash equivalents | $ (83,977) | (3,082,282) |
Cash and cash equivalents, beginning of period | 556,318 | 3,638,600 |
Cash and cash equivalents, end of period | 472,341 | 556,318 |
SUPPLEMENTAL DISCLOSURES OF CASH FLOW ACTIVITIES | ||
Interest paid | 319,282 | 434,115 |
Income taxes paid | 3,364 | 3,665 |
Conversion of notes payable to common stock | $ 18,000 | 1,621,862 |
Conversion of accrued interest payable to common stock | $ 147,338 |
DESCRIPTION OF BUSINESS
DESCRIPTION OF BUSINESS | 12 Months Ended |
Dec. 31, 2015 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
DESCRIPTION OF BUSINESS | NOTE 1—DESCRIPTION OF BUSINESS Organization Emmaus Medical is a Delaware corporation originally incorporated on September 12, 2003. Emmaus Medical, LLC was organized on December 20, 2000. In October 2003, Emmaus Medical, LLC conducted a reorganization and merged with Emmaus Medical. As a result of the merger, Emmaus Medical acquired the exclusive patent rights for a treatment for sickle cell disease ("SCD"). In October 2010, the Company established Emmaus Medical Japan, Inc., a Japanese corporation ("EM Japan") by funding 97% of the initial capital. EM Japan is engaged in the business of trading in nutritional supplements and other medical products and drugs. The results of EM Japan have been included in the consolidated financial statements of the Company since the date of formation. The aggregate formation cost was $52,500. Emmaus Medical acquired the additional 3% of the outstanding shares of EM Japan during the three months ended March 31, 2011 and is now the 100% owner of the outstanding share capital. In November 2011, the Company formed Emmaus Medical Europe, Ltd. ("EM Europe"), a wholly owned subsidiary of Emmaus Medical. EM Europe's primary focus is expanding the business of Emmaus Medical in Europe. Emmaus, its wholly-owned subsidiary, Emmaus Medical, and Emmaus Medical's wholly-owned subsidiaries, Newfield Nutrition Corporation ("Newfield Nutrition"), EM Japan and EM Europe, are collectively referred to herein as the "Company." Nature of Business To a lesser extent, the Company is also engaged in the marketing and sale of NutreStore®, which has received approval from the U.S. Food and Drug Administration ("FDA"), as a treatment for short bowel syndrome ("SBS") in patients receiving specialized nutritional support when used in conjunction with a recombinant human growth hormone that is approved for this indication. The Company's indirect wholly-owned subsidiary, Newfield Nutrition, sells L- glutamine as a nutritional supplement under the brand name AminoPure® through retail stores in multiple states in the United States and via importers and distributors in Japan, Taiwan and South Korea. The Company also owns a minority interest of less than 1% in CellSeed, Inc., a Japanese company listed on the Tokyo Stock Exchange ("CellSeed"), which is engaged in research and development of regenerative medicine products and the manufacture and sale of temperature-responsive cell culture equipment. The Company also is involved in research focused on providing innovative solutions for tissue-engineering through the development of novel cell harvest methods and three-dimensional living tissue replacement products for "cell sheet therapy" and regenerative medicine and the future commercialization of such products. Correction of Immaterial Prior Year Errors —During the first quarter of 2016, management became aware of prior period accounting errors related to stock option accounting that were made in the previously filed SEC Form 10-K for the year ended December 31, 2014. Specifically, the prior period accounting errors involving shared based payments instruments related to not appropriately accounting for stock option modifications and not re-measuring the fair value of stock options issued to non-employees from the issuance date until the services required under the arrangement had been completed. Further, during the preparation and filing of its financial statements for the three months ended March 31, 2015, the Company identified and disclosed an immaterial error relating to certain warrant derivative liability instruments for its financial statements as of and for the years ended December 31, 2013 and 2014 as well as the interim periods ended September 30, 2013 and 2014. This prior period error involved not recording a purchase warrant for the purchase of 300,000 shares of the common stock of the Company issued to a certain broker as compensation for services rendered in a private placement transaction during 2013. These purchase warrants were deemed to be a derivative liability instrument and had an initial fair value of $681,000 on the date of transaction of which $62,000 needed to be allocated to additional paid in capital and $619,000 charged as transaction costs. The Company did not account for changes in the fair value of these warrants in periods subsequent to their issuance. This immaterial error was then corrected by adjusting the prior-period information in the financial statements as of and for the three months ended March 31, 2015. The cumulative adjustments to the consolidated statements of comprehensive loss for fiscal year ended December 31, 2014 for the stock option accounting errors and that related to warrant derivative were $651,174 and $290,000, respectively, for an aggregate incremental charge of $941,174. The adjustments to the consolidated statements of comprehensive loss for the fourth quarter of 2014 for the stock option accounting errors and that related to warrant derivative liabilities applicable to were ($99,169) and ($74,000), respectively, for an aggregate reduction of expenses of ($173,169). Pursuant to the guidance of Staff Accounting Bulletin ("SAB") No. 99, Materiality, the Company evaluated these errors individually as well as in the aggregate and concluded that the errors were not material to any of its prior period financial statements. Although the errors were immaterial to prior periods, the prior period financial statements were revised, in accordance with SAB No. 108, Considering the Effects of Prior Year Misstatements when Quantifying Misstatements in Current Year Financial Statements, due to the significance of the out-of-period correction. A reconciliation of the effects of the adjustments to the previously reported consolidated balance sheet at December 31, 2014 follows: As Previously Reported Adjustment As Revised Warrant derivative liabilities 5,641,000 879,000 6,520,000 Total liabilities 22,963,954 879,000 23,842,954 Additional paid in capital 50,479,843 588,834 51,068,677 Accumulated deficit (70,616,002 ) (1,467,834 ) (72,083,836 ) Total stockholder's deficit (20,299,662 ) (879,000 ) (21,178,662 ) A reconciliation of the effect of the adjustments to the previously reported consolidated statement of comprehensive loss for the year ended December 31, 2014 follows: As Previously Reported Adjustment As Revised General and adminstrative 11,904,092 651,174 12,555,266 Loss from operations (14,305,569 ) (651,174 ) (14,956,743 ) Change in fair value of warrant derivative liabilities 474,000 74,000 548,000 Loss before income taxes (20,813,475 ) (941,174 ) (21,754,649 ) A reconciliation of the effect of the adjustments to the previously reported consolidated statements of cash flows for the year ended December 31, 2014 follows: As Previously Reported Adjustment As Revised Net loss (20,817,140 ) (941,174 ) (21,758,314 ) Share-based compensation 5,870,638 651,174 6,521,812 Change in fair value of warrant derivative liabilities (474,000 ) (74,000 ) (548,000 ) |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | NOTE 2—SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of presentation Going concern Principles of consolidation Estimates The warrants issued by the Company in a private placement in September 2013 and replacement warrants issued in June 2014 contain non-standard anti- dilution protection and, consequently, are being accounted for as liabilities that are remeasured to fair market value at each reporting period (Note 7). In addition, the remaining initial private placement warrants may now utilize a cashless exercise feature since the shares associated with them were not registered by the one-year anniversary of their issue. These warrants have now been reclassified from liability classified warrants to warrant derivative liabilities and to continue to be remeasured at fair value each reporting period. The initial value as well as the fair value of all such warrants were determined using a Binomial Monte-Carlo Cliquet (aka Ratchet) Option Pricing Model. The model is similar to traditional Black-Scholes-type option pricing models except that the exercise price resets at certain dates in the future. Actual results could differ from those estimates. Cash and cash equivalents Inventories All of the raw material purchases during the year ended December 31, 2015 and 2014 was from one vendor. The below table presents inventory by category: December 31, Inventory by category 2015 2014 Raw materials and components $ — $ 43,700 Work-in-process 45,355 27,665 Finished goods 173,808 179,048 Total $ 219,163 $ 250,413 Prepaid expenses and other current assets —Prepaid expenses and other current assets consisted of the following at December 31, 2015 and 2014: December 31, December 31, Prepaid insurance $ 97,708 $ 86,061 Other prepaid expenses and current assets 33,405 43,493 $ 131,113 $ 129,554 Deposits Revenue recognition With prior written approval of the Company, in certain situations, product is returnable only by its direct customers for a returned goods credit, for product that is expired, damaged in transit, or which is discontinued, withdrawn or recalled. The Company estimates its sales returns based upon its prior sales and return history and accrues a sales return allowance at the time of sale. Historically, sales returns have been immaterial. The Company pays royalties on an annual basis based on existing license arrangements. These royalties are recognized as cost of goods sold upon sale of the products. Allowance for doubtful accounts Advertising cost Property and equipment Intangibles Impairment of long-lived assets If the Company determines that the carrying values of long-lived assets may not be recoverable based upon the existence of one or more indicators of impairment, the Company performs an undiscounted cash flow analysis to determine if impairment exists. If impairment exists, the Company measures the impairment based on the difference between the asset's carrying amount and its fair value, and the impairment is charged to consolidated statement of comprehensive loss in the period in which the long-lived asset impairment is determined to have occurred. The Company has determined that an impairment of the carrying value of its long-lived assets existed at December 31, 2015 (Note 4) and no impairment existed at December 31, 2014. Research and development Share-based compensation Income taxes For balance sheet presentation, current deferred tax assets and liabilities within each tax jurisdiction have been offset and presented as a single amount and non-current deferred tax assets and liabilities within each tax jurisdiction have been offset and presented as a single amount. When tax returns are filed, it is highly probable that some positions taken would be sustained upon examination by the taxing authorities, while others are subject to uncertainty about the merits of the position taken or the amount of the position that would be ultimately sustained. The benefit of a tax position is recognized in the financial statements in the period during which, based on all available evidence, management believes it is more likely than not that the position will be sustained upon examination, including the resolution of appeals or litigation processes, if any. Tax positions taken are not offset or aggregated with other positions. Tax positions that meet the more- likely-than-not recognition threshold are measured as the largest amount of tax benefit that is more than 50 percent likely of being realized upon settlement with the applicable taxing authority. The portion of the benefits associated with tax positions taken that exceeds the amount measured as described above is reflected as a liability for unrecognized tax benefits along with any associated interest and penalties that would be payable to the taxing authorities upon examination. As of December 31, 2015, the Company had no unrecognized tax benefits, and the Company had no positions which, in the opinion of management, would be reversed if challenged by a taxing authority. In the event the Company is assessed interest and/or penalties, such amounts will be classified as income tax expense in the financial statements. As of December 31, 2015, all federal tax returns since 2012 and state tax returns since 2011 are still subject to adjustment upon audit. No tax returns are currently being examined by taxing authorities. Comprehensive income (loss) Marketable securities In July 2013, based on an increase in market value of CellSeed shares, Mitsubishi UFJ Capital III Limited Partnership (Mitsubishi) released to the Company 34,300 shares of CellSeed stock. This was part of the 73,550 shares of CellSeed stock held by Mitsubishi as collateral on a $500,000 convertible note issued to Mitsubishi which is due in 2016 ("the Mitsubishi note"). The Mitsubishi note is now secured by the remaining 39,250 shares of CellSeed stock held by Mitsubishi as collateral. During the fourth quarter of 2015, the Company sold 9,300 of the shares released from Mitsubishi in open market transactions for $71,517. The remaining 39,250 shares of CellSeed stock are pledged to secure the Mitsubishi note and are classified as marketable securities, pledged to creditor. Gain on derecognition of accounts payable and settlement of litigation Foreign Currency Translation Financial Instruments Fair value measurements Level 1: Inputs to the valuation methodology are unadjusted quoted prices for identical assets or liabilities in active markets that the Company has the ability to access. Level 2: Inputs to the valuation methodology include: • Quoted prices for similar assets or liabilities in active markets; • Quoted prices for identical or similar assets or liabilities in inactive markets; • Inputs other than quoted prices that are observable for the asset or liability; • Inputs that are derived principally from or corroborated by observable market data by correlation or other means. If the asset or liability has a specified (contractual) term, the Level 2 inputs must be observable for substantially the full term of the asset or liability. Level 3: Inputs to the valuation methodology are unobservable and significant to the fair value measurement. The asset's or liability's fair value measurement level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Valuation techniques used need to maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value assigned to marketable securities is determined by obtaining quoted prices on nationally recognized securities exchanges, and are classified as Level 1 investments at December 31, 2015 and 2014. The fair value of the Company's debt instruments is not materially different from their carrying values as presented. The fair value of the Company's convertible debt instruments was determined based on Level 2 inputs. The carrying value of the debt was discounted based on allocating proceeds to other financial instruments within the arrangement as discussed in Note 6. The Company issued stock purchase warrants in conjunction with its September 2013 private placement and issued replacement warrants upon the exercise of certain of such warrants in June 2014 (see Note 1 and Note 7). Such warrants and replacement warrants contain non-standard anti-dilution protection, and consequently, are accounted for as liabilities measured at fair value on a recurring basis, whose fair value is determined using Level 3 inputs. In addition, the remaining initial private placement warrants may now utilize a cashless exercise feature since the shares associated with them were not registered by the one-year anniversary of their issue. These warrants have now been reclassified from liability classified warrants to warrant derivative liabilities and continue to be remeasured at fair value each reporting period. The Level 3 inputs in the valuation of warrants include expected term and expected volatility. The following tables present the activity for those items measured at fair value on a recurring basis using Level 3 inputs during 2015 and 2014: Year ended December 31, Liability Classified Warrants—Stock Purchase Warrants 2015 2014 Balance, beginning of period $ 3,206,000 $ 6,517,000 Fair value at issuance date — 3,523,000 Settlement of liability associated with warrants exercised — (1,752,744 ) Reclassification to warrant derivative liabilities (2,545,000 ) (7,068,000 ) Reduction of the warrants exercised to intrinsic value included in the statement of comprehensive loss — (1,770,256 ) Change in fair value included in the statement of comprehensive loss (661,000 ) 3,757,000 Balance, end of period $ — $ 3,206,000 Year ended December 31, Warrant Derivative Liabilities—Stock Purchase Warrants 2015 2014 Balance, beginning of period $ 6,520,000 $ — Reclassification from liability classified warrants 2,545,000 7,068,000 Change in fair value included in the statement of comprehensive loss (1,202,000 ) (548,000 ) Balance, end of period $ 7,863,000 $ 6,520,000 The value of the liability classified warrants , the value of warrant derivative liability and the change in fair value of the liability classified warrants and warrant derivative liability were determined using a Binomial Monte-Carlo Cliquet (aka Ratchet) Option Pricing Model. The model is similar to traditional Black-Scholes-type option pricing models except that the exercise price resets at certain dates in the future. The values as of December 31, 2015, December 31, 2014, December 31, 2013 and the initial value as of September 11, 2013 were calculated based on the following assumptions: December 31, 2015 December 31, 2014 December 31, 2013 Initial Value Stock price $ 4.70 $ 4.90 $ 3.60 $ 3.60 Risk-free interest rate 1.23 % 1.38 % 1.75 % 1.72 % Expected volatility (peer group) 64.10 % 71.50 % 63.20 % 72.40 % Expected life (in years) 2.70 3.70 4.70 5.00 Expected dividend yield — — — — Number outstanding 3,320,501 3,320,501 3,320,501 3,320,501 Balance, end of period: Liability classified warrants $ — $ 3,206,000 $ 6,517,000 $ 7,541,000 Warrant derivative liabilities $ 7,863,000 $ 6,520,000 $ — $ — Debt and Related Party Debt Debt with Conversion and Other Options Type of Loan Term of Loan Stated Annual Interest Rate Original Loan Principal Amount Conversion Rate Beneficial Conversion Discount Amount Warrants Issued with Notes Exercise Price Warrant FMV Discount Amount Effective Interest Rate Including Discounts 2014 convertible notes payable 6 mo. ~ 2 years 10 % $ 3,096,266 $3.05 ~ $3.60 $ 1,392,387 50,000 $ 3.50 $ 126,732 28% ~ 100% 2015 convertible notes payable Due on demand ~ 2 years 10 % 4,051,022 $3.50 ~ $4.50 1,388,201 110,417 $ 4.90 220,071 14% ~ 109% Total $ 7,147,288 $ 2,780,588 160,417 $ 346,803 Related party notes are disclosed as separate line items in the Company's balance sheet presentation. Net loss per share "Earnings per Share, Recent accounting pronouncements Interest—Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issuance Costs transition, an entity is required to comply with the applicable disclosures for a change in an accounting principle. These disclosures include the nature of and reason for the change in accounting principle, the transition method, a description of the prior-period information that has been retrospectively adjusted, and the effect of the change on the financial statement line items (that is, the debt issuance cost asset and the debt liability). The adoption of the amendments in this Update is not expected to have material impact on the Company's consolidated financial position or results of operations. In July 2015, the FASB issued ASU No. 2015-11, Simplifying the Measurement of Inventory , to simplify the measurement of inventory, redefining measurement from lower of cost or market to lower of cost and net realizable value. The amendments in this Update require an entity using the first-in, first-out (FIFO) or average cost method of measuring inventory to measure inventory at the lower of cost and net realizable value, defined as the estimated selling prices in the ordinary course of business less reasonably predictable costs of completion, disposal, and transportation. The amendments in this Update should be applied prospectively, and are effective for the Company for fiscal years beginning after December 15, 2016, including interim periods within those years. The adoption of the amendments in this Update is not expected to have material impact on the Company's consolidated financial position or results of operations. In January 2016, the FASB issued ASU No. 2016-01, Recognition and Measurement of Financial Assets and Financial Liabilities . The amendments applicable to the Company in this Update (1) supersede the guidance to classify equity securities, except equity method securities, with readily determinable fair values into trading or available-for-sale categories and require equity securities to be measured at fair value with changes in the fair value recognized through net income, (2) allow equity investments that do not have readily determinable fair values to be remeasured at fair value either upon the occurrence of an observable price change or upon identification of an impairment, (3) require assessment for impairment of equity investments without readily determinable fair values qualitatively at each reporting period, (4) eliminate the requirement to disclose the methods and significant assumptions used in calculating the fair value of financial instruments required to be disclosed for financial instruments measured at amortized cost on the balance sheet, (5) require public business entities to use the exit price notion when measuring the fair value of financial instruments for disclosure purposes, (6) require separate presentation of financial assets and financial liabilities by measurement category and form of financial asset (that is, securities or loans and receivables) on the balance sheet or the accompanying notes to the financial statements, (7) clarify that an entity should evaluate the need for a valuation allowance on a deferred tax asset related to available-for-sale securities in combination with the entity's other deferred tax assets. The amendments in this Update are effective for the Company for fiscal years beginning after December 15, 2017, including interim periods within those years. The amendments should be applied by means of a cumulative-effect adjustment to the balance sheet as of the beginning of the fiscal year of adoption. The amendments related to equity securities without readily determinable fair values (including disclosure requirements) should be applied prospectively to equity investments that exist as of the date of adoption of the Update. The impact of the adoption of the amendments in this Update will depend on the amount of equity securities and financial instruments subject to the amendments in this Update held by the Company at the time of adoption. In February 2016, the FASB issued ASU No. 2016-02, Leases. In March 2016, the FASB issued ASU 2016-09, Compensation—Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting . The amendments in this Update simplify the accounting for share-based payment award transactions including: income tax consequences, classification of awards as either equity or liabilities and classification on the statement of cash flows. This Update is effective for annual periods beginning after December 15, 2016, including interim periods within those annual periods. Early adoption is permitted. The Company is currently in the process of evaluating this Update. |
PROPERTY AND EQUIPMENT
PROPERTY AND EQUIPMENT | 12 Months Ended |
Dec. 31, 2015 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY AND EQUIPMENT | NOTE 3—PROPERTY AND EQUIPMENT Property and equipment consisted of the following at: December 31, 2015 December 31, 2014 Equipment $ 164,931 $ 160,201 Leasehold improvements 30,579 30,579 Furniture and fixtures 74,682 74,683 270,192 265,463 Less: accumulated depreciation (211,965 ) (193,072 ) Total $ 58,227 $ 72,391 During the years ended December 31, 2015 and 2014, depreciation expense was $18,893 and $16,620, respectively. |
INTANGIBLE ASSETS
INTANGIBLE ASSETS | 12 Months Ended |
Dec. 31, 2015 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
INTANGIBLE ASSETS | NOTE 4—INTANGIBLE ASSETS Intangible assets consist of license fees and patent filing costs associated with NutreStore® L-glutamine powder for oral solution as a treatment for SBS and the Company's right to manufacture, sell, market and distribute Cultured Autologous Oral Mucosal Epithelial Cell-Sheet ("CAOMECS") under agreements with CellSeed, described in further detail below. In April 2011, the Company entered into that certain Joint Research and Development Agreement dated as of April 8, 2011 (the "Research Agreement") as well as that certain Individual Agreement dated as of April 8, 2011 (the "Individual Agreement") with CellSeed and, in August 2011, entered into an addendum to the Research Agreement. Pursuant to the Individual Agreement, CellSeed granted the Company the exclusive right to manufacture, sell, market and distribute CAOMECS for the cornea in the United States and agreed to disclose to the Company its accumulated information package for the joint development of CAOMECS. Under the Individual Agreement, the Company agreed to pay CellSeed $1.5 million, which it paid in February 2012. The technology acquired under the Individual Agreement is being used to support an ongoing research and development project and management believes the technology has alternative future uses in other future development initiatives. Pursuant to the Research Agreement, the Company and CellSeed formed a relationship regarding the future research and development of cell sheet engineering regenerative medicine products. Under the Research Agreement, as supplemented by the addendum, the Company agreed to pay CellSeed $8.5 million within 30 days after the completion of all of the following: (i) the execution of the Research Agreement; (ii) the execution of the Individual Agreement; and (iii) CellSeed's delivery of the accumulated information package, as defined in the Research Agreement, to the Company and the Company providing written confirmation of its acceptance of the complete Package, which has not yet been completed as of December 31, 2015. During the fourth quarter of 2015, CellSeed disclosed to the Company that its exclusive license to CAOMECS was not truly exclusive, since CellSeed had granted another company a license to CAOMECS in the U.S. prior to its license to the Company. On December 29, 2015, the Company and CellSeed terminated the Research Agreement and the Individual Agreement. The Company no longer has an obligation to pay the $8.5 million or any other unpaid amount under the terminated agreements. As a result of the disclosure of the pre-existing license and the termination of the Research Agreement and the Individual Agreement, and uncertainty surrounding the recoverability of the intangible asset associated with CAOMECS license fees paid, during the year ended December 31, 2015, the Company recorded an impairment loss of $678,571, which represents the remaining carrying value of the intangible asset associated with CAOMECS license fees paid. The Company had previously estimated the economic life of the CAOMECS produced in connection with the CellSeed Research and Individual Agreement at seven years. The determination of this life was based in part on the Company's estimate of economic useful life and the time period in which the Company may enjoy an advantage over competing technologies and techniques. Key reasons for a useful life shorter than the life of a patent include: (i) the patents related to this technology are yet to be approved, (ii) potential redundancy with similar medication/device due to changes in market preferences, (iii) uncertainty of regulatory approval and (iv) potential development of new treatments for the same disease. Intangible assets, net consisted of the following at: December 31, 2015 December 31, 2014 License fees and patent filing costs $ 2,000,000 $ 2,000,000 Less: accumulated amortization (1,321,429 ) (1,107,143 ) Impairment loss (678,571 ) — Intangible assets, net $ — $ 892,857 During the years ended December 31, 2015 and 2014, amortization expense was $214,286. |
ACCOUNTS PAYABLE AND ACCRUED EX
ACCOUNTS PAYABLE AND ACCRUED EXPENSES | 12 Months Ended |
Dec. 31, 2015 | |
Payables and Accruals [Abstract] | |
ACCOUNTS PAYABLE AND ACCRUED EXPENSES | NOTE 5—ACCOUNTS PAYABLE AND ACCRUED EXPENSES Accounts payable and accrued expenses consisted of the following at: December 31, 2015 December 31, 2014 Accounts payable Clinical and regulatory expenses $ 322,193 $ 266,537 Legal expenses 242,384 176,691 Other vendors 959,333 774,444 Subtotal 1,523,910 1,217,672 Accrued interest payable, related parties 176,940 110,200 Accrued interest payable 1,586,472 761,682 Accrued expenses 201,506 220,200 Deferred salary 291,666 291,666 Total accounts payable and accrued expenses $ 3,780,494 $ 2,601,420 |
NOTES PAYABLE
NOTES PAYABLE | 12 Months Ended |
Dec. 31, 2015 | |
Debt Disclosure [Abstract] | |
NOTES PAYABLE | NOTE 6—NOTES PAYABLE Notes payable consisted of the following at December 31, 2015: Year Issued Interest Rate Range Term of Notes Conversion Price Principal Outstanding December 31, 2015 Discount Amount December 31, 2015 Carrying Amount December 31 2015 Shares Underlying Notes December 31, 2015 Principal Outstanding December 31, 2014 Discount Amount December 31, 2014 Carrying Amount December 31, 2014 Shares Underlying Notes December 31, 2014 Notes payable 2014 11% Due on — 1,446,950 — 1,446,950 — 1,446,950 — 1,446,950 — 2015 11% Due on — 2,379,799 — 2,379,799 — — — — — ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ $ 4,656,749 — $ 4,656,749 — $ 2,476,950 $ — $ 2,476,950 — ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Current $ 4,656,749 $ — $ 4,656,749 — $ 1,643,615 $ — $ 1,643,615 — Long-term $ — $ — $ — — $ 833,335 $ — $ 833,335 — Notes payable—related party 2013 8% Due on demand — 50,000 — 50,000 — 50,000 — 50,000 — 2014 11% Due on — 240,308 — 240,308 — 252,165 — 252,165 — 2015 10% ~ 11% Due on — 1,849,266 — 1,849,266 — — — — — ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ $ 2,766,304 $ — $ 2,766,304 — $ 958,895 $ — $ 958,895 — ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Current $ 2,766,304 $ — $ 2,766,304 — $ 825,562 $ — $ 825,562 — Long-term $ — $ — $ — — $ 133,333 $ — $ 133,333 — Convertible notes payable 2011 10% 5 years $3.05 500,000 — 500,000 163,809 500,000 — 500,000 163,809 2013 10% 2 years $3.60 525,257 — 525,257 185,553 2,463,299 18,750 2,444,549 834,667 2014 10% Due on $3.05 ~$7.00 4,378,563 353,700 4,024,863 1,120,470 4,939,773 846,613 4,093,160 1,241,241 2015 10% Due on $3.50 ~$7.00 5,681,166 526,066 5,155,100 1,517,996 — — — — ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ $ 11,086,986 $ 879,766 $ 10,207,220 2,988,484 $ 7,977,072 $ 868,558 $ 7,108,514 2,263,965 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Current $ 6,358,698 $ 358,351 $ 6,000,347 1,762,849 $ 3,478,904 $ 21,945 $ 3,456,959 1,156,050 Long-term $ 4,728,288 $ 521,415 $ 4,206,873 1,225,635 $ 4,498,168 $ 846,613 $ 3,651,555 1,107,915 Convertible notes payable—related party 2014 10% 2 years $7.00 — — — — 200,000 — 200,000 30,187 2015 10% 2 years $4.50 320,000 — 320,000 72,354 — — — — ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ $ 618,000 $ — $ 618,000 180,859 $ 573,000 $ — $ 573,000 151,648 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Current $ 298,000 $ — $ 298,000 108,505 $ 373,000 $ — $ 373,000 121,461 Long-term $ 320,000 $ — $ 320,000 72,354 $ 200,000 $ — $ 200,000 30,187 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Grand Total $ 19,128,039 $ 879,766 $ 18,248,273 3,169,343 $ 11,985,917 $ 868,558 $ 11,117,359 2,415,613 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ The average stated interest rate of notes payable for the years ended December 31, 2015 and 2014 was 10% in each period. The average effective interest rate of notes payable for the years ended December 31, 2015 and 2014 was 23% in each period, after giving effect to discounts relating to beneficial conversion features and the fair value of warrants issued in connection with these notes. The notes payable and convertible notes payable do not have restrictive financial covenants or acceleration clauses associated with a material adverse change event. The holders of the convertible notes have the option to convert their notes into the Company's common stock at the stated conversion price during the term of their convertible notes. Conversion prices on these convertible notes payable range from $3.05 to $3.60 per share. Certain notes with a $4.50 and a $7.00 stated conversion price in the second year of their two-year term are subject to automatic conversion into shares of the Company's common stock at a conversion price equal to 80% of the initial public offering price at the time of a qualified public offering. All due on demand notes are treated as current liabilities. Contractual principal payments due on notes payable are as follows: Year Ending at December 31, 2015 2016 $ 14,079,751 2017 5,048,288 ​ ​ ​ ​ ​ Total $ 19,128,039 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ The Company estimated the total fair value of any beneficial conversion feature and accompanying warrants in allocating the debt proceeds. The proceeds allocated to the beneficial conversion feature were determined by taking the estimated fair value of shares issuable under the convertible notes less the fair value of the number of shares that would be issued if the conversion rate equaled the fair value of the Company's common stock as of the date of issuance (see Note 2). The fair value of the warrants issued in conjunction with notes was determined using the Black-Scholes-Merton option pricing model with the following inputs for the years ended: 2015 2014 Stock price $ 4.50 $ 4.90 Exercise price $ 4.90 $ 3.50 Term 5 years 5 years Risk-free interest rate 1.57 % 1.66 % Expected dividend yield — — Expected volatility 67.30 % 70.10 % In situations where the debt included both a beneficial conversion feature and a warrant, the proceeds were allocated to the warrants and beneficial conversion feature based on the pro-rata fair value. |
STOCKHOLDERS' DEFICIT
STOCKHOLDERS' DEFICIT | 12 Months Ended |
Dec. 31, 2015 | |
Stockholders' Equity Note [Abstract] | |
STOCKHOLDERS' DEFICIT | NOTE 7—STOCKHOLDERS' DEFICIT Private Placement The warrants contain non-standard anti-dilution protection and, consequently, are being accounted for as liabilities, were originally recorded at fair value, and are adjusted to fair market value each reporting period. Because the shares of common stock underlying the Private Placement warrants and Broker Warrants were not effectively registered for resale by September 11, 2014, the warrant holders have an option to exercise the warrants using a cashless exercise feature. The shares have not been registered for resale as of December 31, 2015. The availability to warrant holders of the cashless exercise feature as of September 11, 2014 caused the then-outstanding 2,225,036 Private Placement warrants and the 300,000 Broker Warrants with fair value of $7,068,000 to be reclassified from liability classified warrants to warrant derivative liabilities and to continue to be remeasured at fair value each reporting period. On June 10, 2014, certain warrant holders exercised 1,095,465 warrants issued in the Private Placement at an exercise price of $3.50 per share, resulting in the Company receiving aggregate exercise proceeds of $3.8 million and issuing 1,095,465 shares of common stock. Prior to exercise, these Private Placement warrants were accounted for at fair value as liability classified warrants. As of June 10, 2014, immediately prior to exercise, the carrying value of these Private Placement warrants was reduced to their fair value immediately prior to exercise of $1.8 million, representing their intrinsic value, with this adjusted carrying value of $1.8 million being transferred to additional paid-in capital. Also on June 10, 2014, based on an offer made to holders of Private Placement warrants in connection with such exercises, the Company issued an aggregate of 1,095,465 replacement warrants to holders exercising Private Placement warrants, which replacement warrants have terms that are generally the same as the exercised warrants, including an expiration date of September 11, 2018 and an exercise price of $3.50 per share. The replacement warrants are treated for accounting purposes as liability classified warrants, and their issuance gave rise to a $3.5 million warrant exercise inducement expense based on their fair value as of issuance as determined using a Binomial Monte-Carlo Cliquet (aka Ratchet) Option Pricing Model. Because the shares of common stock underlying the replacement warrants were not effectively registered for resale by June 10, 2015, the warrant holders have an option to exercise the warrants using a cashless exercise feature. The shares have not been registered for resale as of December 31, 2015. The availability to warrant holders of the cashless exercise feature as of June 10, 2015 caused the then-outstanding 1,095,465 replacement warrants with fair value of $2,545,000 to be reclassified from liability classified warrants to warrant derivative liabilities and to continue to be remeasured at fair value each reporting period. Stock cancellations As of December 31, 2015, the fair value of these Private Placement warrants, replacement warrants, and Broker Warrants was $7,863,000 (see Note 2). For further details regarding registration rights associated with the Private Placement warrants, replacement warrants, and Broker Warrants, see the Registration Rights section below in this footnote. Stock warrants Warrant exercises and issuance In addition to the above, during the year ended December 31, 2015, the Company issued 148,256 shares of common stock upon the exercise of warrants at exercise prices ranging from $1.00 to $3.05 per share, including 75,838 warrants exercised on a cashless basis. A summary of outstanding warrants as of December 31, 2015 and 2014 is presented below. Year ended December 31, 2015 Year ended December 31, 2014 Warrants outstanding, beginning of period 5,101,450 6,279,296 Granted 110,417 1,145,465 Exercised (148,256 ) (1,254,621 ) Cancelled, forfeited and expired (1,532,693 ) (1,068,690 ) Warrants outstanding, end of period 3,530,918 5,101,450 ​ ​ ​ ​ ​ ​ ​ ​ A summary of outstanding warrants by year issued and exercise price as of December 31, 2015 is presented below. Outstanding Exercisable Exercise Price Number of Warrants Issued Weighted Average Remaining Contractual Life (Years) Weighted Average Exercise Price Total Weighted Average Exercise Price During 2013 $3.30 50,000 2.33 $ 3.30 50,000 $ 3.30 $3.50 2,225,036 2.70 $ 3.50 2,225,036 $ 3.50 2013 total 2,275,036 2,275,036 During 2014 $3.50 1,145,465 2.73 $ 3.50 1,145,465 $ 3.50 2014 total 1,145,465 1,145,465 During 2015 $4.90 110,417 4.18 $ 4.90 110,417 $ 4.90 Total 3,530,918 3,530,918 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Stock options Management has valued stock options at their date of grant utilizing the Black-Scholes-Merton Option pricing model. The fair value of the underlying shares was determined by the market value of stock of similar companies and recent arm's length transactions involving the sale of the Company's common stock. The expected volatility was calculated using the historical volatility of a similar public entity in the industry through August 2013 and a group of similar public entities thereafter. The following table presents the assumptions used on recent dates on which options were granted by the Board of Directors. July 17, 2014 May 8, 2014 February 26, 2014 Stock price $ 5.10 $ 4.90 $ 3.60 Exercise price $ 5.10 $ 4.90 $ 3.60 Term 10 years 10 years 10 years Risk-Free Interest Rate 2.47 % 2.61 % 2.67 % Dividend Yield 0.00 % 0.00 % 0.00 % Volatility 77.90 % 75.50 % 76.60 % In making the determination of fair value and finding similar companies, the Company considered the industry, stage of life cycle, size and financial leverage of such other entities. While the Company was initially able to identify only one similar public company using these criteria, based on the more advanced stage of development of the Company additional similar companies with enough historical data that met the industry criterion have now been identified. Accordingly, the Company has based its expected volatility on the historical stock prices of a group peer of companies since September 2013. The risk-free interest rate is based on the implied yield available on U.S. Treasury issues with an equivalent term approximating the expected life of the options depending on the date of the grant and expected life of the options. During the year ended December 31, 2015, no options were granted by the Company's Board of Directors. During the year ended December 31, 2014, the Company's Board of Directors granted 840,000 options to its directors, employees and consultants. In addition, 340,000 options that were approved by the Company's Board of Directors in April 2012 were deemed issued during the year ended December 31, 2014. The aggregate fair value of these tranches of options, including options granted or deemed issued in 2014 was approximately $3.0 million. As of December 31, 2015, there were 4,753,335 options outstanding under the 2011 Stock Incentive Plan. A summary of the Company's stock option activity for the years ended December 31, 2015 and 2014 is presented below. Prior Plan December 31, 2015 December 31, 2014 Number of Options Weighted- Average Exercise Price Number of Options Weighted- Average Exercise Price Number of Options Weighted- Average Exercise Price Options outstanding, beginning of period 11,795 $ 3.05 5,669,000 $ 3.68 4,504,000 $ 3.58 Granted or deemed issued — — — — 1,180,000 $ 4.06 Exercised — — (2,000 ) $ 3.60 — — Cancelled, forfeited and expired (11,795 ) $ 3.05 (913,665 ) $ 4.05 (15,000 ) $ 3.60 Options outstanding, end of period — — 4,753,335 $ 3.60 5,669,000 $ 3.68 Options exercisable at end of year — — 4,379,335 $ 3.60 2,855,251 $ 3.55 Options available for future grant — — 4,246,665 — 3,331,000 — ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ The weighted average grant-date fair value of options granted or deemed issued during the year ended December 31, 2014 was $2.58. The weighted average grant-date fair value of common shares underlying stock options granted or deemed issued during the year ended December 31, 2014 was $4.06. During the years ended December 31, 2015 and 2014, the Company recognized $3.7 million and $6.5 million of share-based compensation cost arising from stock option grants. As of December 31, 2015, there was $0.7 million of total unrecognized compensation cost related to unvested share-based compensation arrangements granted under the 2011 Stock Incentive Plan. That cost is expected to be recognized over the weighted average remaining period of 0.5 years. Registration Rights If the shares of common stock underlying warrants to purchase 2,225,036 shares are not registered for resale at the time of exercise or if the shares of common stock underlying warrants to purchase 1,095,465 shares are not registered for resale at the time of exercise, and in each such case the registration rights described above then apply with respect to the holder of such warrants, such holder may exercise such warrants on a cashless basis. In such a cashless exercise of all the shares covered by the warrant, the warrant holder would receive a number of shares equal to the quotient of (i) the difference between the fair market value of the common stock, as defined, and the $3.50 exercise price, as adjusted, multiplied by the number of shares exercisable under the warrant, divided by (ii) the fair market value of the common stock, as defined. As of December 31, 2015, based on a fair market value of a share of the Company's common stock of $4.70 and 3,320,501 warrants issued and outstanding and eligible for cashless exercise, the maximum number of shares the Company would be required to issue, if the warrant holders elected to exercise the cashless exercise feature with respect to all then eligible warrants, is 847,787 shares. If the fair market value of a share of the Company's common stock were to increase by $1.00 from $4.70 to $5.70, the maximum number of shares the Company would be required to issue, if the warrant holders elected to exercise the cashless exercise feature with respect to all then eligible warrants, would increase to 1,281,597 shares as of December 31, 2015. The Company has not yet filed a registration statement with respect to the resale of the Registrable Securities because doing so is not feasible prior to the completion by the Company of its initial public offering. As previously reported, the Company has filed a draft registration statement with the SEC with respect to its proposed initial public offering. The Company believes that it has used commercially reasonable efforts to pursue an initial public offering and, accordingly, considers itself to be in compliance with its registration rights obligations notwithstanding that it has not filed a registration statement with respect to the resale of the Registrable Securities and the deadline for doing so has passed without extension. |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | NOTE 8—INCOME TAXES The provision for income taxes consists of the following for the years ended December 31: 2015 2014 Current U.S. $ 2,400 $ 2,500 International 1,164 1,165 Deferred U.S. — — International — — $ 3,564 $ 3,665 A valuation allowance for the net deferred tax assets has been recorded as it is more likely than not that these benefits will not be realized through future operations. Deferred tax assets consist of the following as of December 31, 2015 and 2014: 2015 2014 Net operating loss carryforward $ 16,650,797 $ 14,354,064 General business tax credit 6,510,162 5,720,604 Stock options 6,271,690 4,843,871 Charitable contribution 79,944 81,434 Accrued expenses 290,083 171,325 Deferred compensation — — Other 444,029 126,983 Total gross deferred tax assets 30,247,605 25,298,281 Less valuation allowance (30,116,742 ) (25,184,004 ) Net deferred tax assets $ 130,863 $ 114,277 Deferred tax liabilities consist of the following as of December 31, 2015 and 2014: 2015 2014 Unrealized gain on foreign exchange translation and others $ (99,228 ) $ (98,825 ) Unrealized gain on securities available-for-sale (31,635 ) (15,452 ) Total deferred tax liability $ (130,863 ) $ (114,277 ) During 2015 and 2014, the valuation allowance increased by $4,932,738 and $5,722,255, respectively. As of December 31, 2015 and 2014, the Company had net operating loss carryforwards for federal reporting purposes of approximately $42,909,000 and $36,673,000 which are available to offset future federal taxable income, if any, through 2035. In addition, the Company had net operating loss carryforwards for state income tax purposes of approximately $40,440,000 and $35,884,000 respectively, which expire in various years through 2035. The utilization of our net operating losses could be subject to an annual limitation as a result of certain past and future events, such as acquisition or other significant equity events, which may be deemed as a "change in ownership" under the provisions of the Internal Revenue Code of 1986, as amended, and similar state provisions. The annual limitations could result in the expiration of net operating losses and tax credits before utilization. As of December 31, 2015 and 2014, the Company has general business tax credits of $6,510,000 and $5,721,000, respectively, for federal tax purposes. The tax credits are available to offset future tax liabilities, if any, through 2024. The income tax provision differs from that computed using the statutory federal tax rate of 34%, due to the following: 2015 2014 Tax benefit at statutory federal rate $ (4,295,120 ) $ (7,022,409 ) State taxes, net of federal tax benefit (469,692 ) (601,078 ) Increase in valuation allowance 4,948,921 5,553,486 Permanent items 675,959 2,842,996 General business tax credit (789,556 ) (983,127 ) Other (66,948 ) 213,797 $ 3,564 $ 3,665 As of December 31, 2015 and 2014, the Company had no unrecognized tax benefits, and the Company had no positions which, in the opinion of management, would be reversed if challenged by a taxing authority. In the event the Company is assessed interest and/or penalties, such amounts will be classified as income tax expense in the financial statements. As of December 31, 2015, all federal tax returns since 2012 and state tax returns since 2011 are still subject to adjustment upon audit. No tax returns are currently being examined by taxing authorities. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2015 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | NOTE 9—COMMITMENTS AND CONTINGENCIES Distribution contract Operating leases Future minimum lease payments under the agreements are as follows: Year Amount 2016 $ 552,696 2017 522,555 2018 490,829 2019 123,875 Total $ 1,689,955 License agreements |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 12 Months Ended |
Dec. 31, 2015 | |
Related Party Transactions [Abstract] | |
RELATED PARTY TRANSACTIONS | NOTE 10—RELATED PARTY TRANSACTIONS The following table sets forth information relating to the Company's loans from related persons outstanding as of December 31, 2015. Class Lender Annual Interest Rate Date of Loan Term of Loan Principal Amount Outstanding at December 31, 2015 Highest Principal Outstanding Amount of Principal Repaid Amount of Interest Paid Conversion Rate Shares Underlying Notes at December 31, 2015 Notes payable to related parties—current: Hope Hospice(1) 8 % 1/17/2012 Due on demand $ 200,000 $ 200,000 $ — $ 8,000 $ — — Hope Hospice(1) 8 % 6/14/2012 Due on demand 200,000 200,000 — 8,000 — — Hope Hospice(1) 8 % 6/21/2012 Due on demand 100,000 100,000 — 4,000 — — Yutaka Niihara(2)(4) 10 % 12/5/2012 Due on demand 126,730 1,213,700 1,086,970 56,722 — — Hope Hospice(1) 8 % 2/11/2013 Due on demand 50,000 50,000 — 2,000 — — Lan T. Tran(2) 11 % 2/10/2014 2 years(3) 106,976 106,976 — — — — Hideki & Eiko Uehara(5) 11 % 2/15/2014 2 years 133,333 133,333 — — — — Hope Hospice(1) 10 % 1/7/2015 2 years(3) 100,000 100,000 — — — — James Lee(5) 10 % 1/26/2015 2 years(3) 50,000 50,000 — — — — Hope Hospice(1) 10 % 1/29/2015 2 years(3) 30,000 30,000 — — — — Yutaka Niihara(2)(4) 10 % 1/29/2015 Due on demand — 20,000 20,000 773 Lan T. Tran(2) 10 % 2/9/2015 2 years(3) 10,000 10,000 — — — — Charles Stark(2) 10 % 2/10/2015 2 years(3) 10,000 10,000 — — — — IRA Service Trust Co. FBO Peter B. Ludlum(2) 10 % 2/20/2015 2 years(3) 10,000 10,000 — — — — Cuc T. Tran(5) 11 % 3/5/2015 1 year 13,161 13,161 — — — — Yutaka Niihara(2)(4) 10 % 4/7/2015 2 years(3) 500,000 500,000 — — — — Yutaka Niihara(2)(4) 10 % 5/21/2015 Due on demand 826,105 826,105 — — — — Masaharu & Emiko Osato(4) 11 % 12/29/2015 Due on demand 300,000 300,000 — — — — Sub total $ 2,766,304 $ 3,873,275 $ 1,106,970 $ 79,495 $ — — Convertible notes payable to related parties—current: Yasushi Nagasaki(2) 10 % 6/29/2012 Due on demand $ 298,000 $ 388,800 $ 90,800 $ — $ 3.30 108,505 Sub total $ 298,000 $ 388,800 $ 90,800 $ — $ — 108,505 Non-Current, convertible notes payable to related parties: Yutaka Niihara(2)(4) 10 % 9/29/2015 2 years $ 100,000 $ 100,000 $ — $ — $ 4.50 22,794 Charles & Kimxa Stark(2) 10 % 10/1/2015 2 years 20,000 20,000 4.50 4,556 Yutaka & Soomi Niihara(2)(4) 10 % 11/16/2015 2 years 200,000 200,000 4.50 45,004 Sub total 320,000 320,000 $ — $ — $ — 72,354 Total $ 3,384,304 $ 4,582,075 $ 1,197,770 $ — $ — 180,859 (1) Dr. Niihara, who is the Company's CEO, is also the CEO of Hope International Hospice, Inc ("Hope Hospice"). (2) Officer (3) Due on Demand (4) Director (5) Family of Officer/Director Class Lender Annual Interest Rate Date of loan Term of Loan Principal Amount Outstanding at December 31, 2014 Highest Principal outstanding Amount of Principal Repaid Amount of Interest Paid Conversion Rate Shares Underlying Notes at December 31, 2014 Current, Promissory note payable to related parties: Hope Hospice(1) 8 % 1/17/2012 Due on demand $ 200,000 $ 200,000 $ — $ 16,000 — — Hope Hospice(1) 8 % 6/14/2012 Due on demand 200,000 200,000 — 20,000 — — Hope Hospice(1) 8 % 6/21/2012 Due on demand 100,000 100,000 — 10,000 — — Yutaka Niihara(2)(4) 10 % 12/5/2012 Due on demand 156,730 1,213,700 1,056,970 60,851 — — Hope Hospice(1) 8 % 2/11/2013 Due on demand 50,000 50,000 — 4,000 — — Lan T. Tran(2) 11 % 2/10/2014 2 years(3) 106,976 106,976 — — — — Cuc T. Tran(5) 11 % 3/5/2014 1 year 11,856 11,856 — — — — Sub total $ 825,562 $ 1,882,532 $ 1,056,970 $ 110,851 — — Current, Convertible notes payable to related parties: Yasushi Nagasaki(2) 10 % 6/29/2012 Due on demand $ 373,000 $ 388,800 $ 15,800 $ 67,680 $ 3.30 121,461 Sub total $ 373,000 $ 388,800 $ 15,800 $ 67,680 — 121,461 Long-term, Promissory note payable to related parties: Hideki & Eiko Uehara(5) 11 % 2/15/2014 2 years $ 133,333 $ 133,333 $ — $ 14,697 — — Sub total $ 133,333 $ 133,333 $ — $ 14,697 — — Long-term, Convertible notes payable to related parties: Phillip M. Satow(4) 10 % 6/6/2014 2 years $ 100,000 $ 100,000 $ — $ — $ 7.00 15,103 Richard S. Pechter(5) 10 % 6/11/2014 2 years 100,000 100,000 — — $ 7.00 15,084 Sub total $ 200,000 $ 200,000 $ — $ — — 30,187 Total $ 1,531,895 $ 2,604,665 $ 1,072,770 $ 193,228 — 151,648 (1) Dr. Niihara, who is the Company's CEO, is also the CEO of Hope Hospice. (2) Officer (3) Due on Demand (4) Director (5) Family of Officer/Director Litigation with AFH Advisory L-glutamine Therapy for SCD and Thalassemia Patent License —On March 1, 2001, the Company became the exclusive worldwide licensee under U.S. Patent No. 5,693,671, entitled "L-glutamine Therapy for SCD and Thalassemia" issued on December 2, 1997 to Niihara et al., (the "SCD Patent"), to develop a treatment approach for SCD and thalassemia using L-glutamine pursuant to a license agreement. The Company's Chief Executive Officer is one of the licensors of the SCD Patent. The license agreement is effective until the expiration of the SCD Patent in May 2016. Pursuant to the license agreement, the Company acquired the exclusive right to test, gain governmental approval of, make, have made, use, distribute and sell products designed for use in carrying out methods covered under the SCD Patent, ("Licensed Methods"), and/or incorporating technical information provided by the licensor or by any of certain doctors affiliated with the licensor ("Licensed Products"). Pursuant to an addendum to the license agreement, the Company agreed to pay royalties to the licensor during the term of the agreement equal to 4.5% of net sales of Licensed Products in the United States until lifetime royalty payments made to the licensor total $100,000, at which time the royalty rate will decrease to 2.5% of net sales of the Licensed Products. No royalties are paid to the licensor for Licensed Products sold or distributed, or Licensed Methods practiced, on a non-profit basis. Royalty payments are due within 45 days after the end of each fiscal quarter, with the last payment due 45 days after the termination of the agreement. Any payments not made when due accrue interest on and after the due date at a rate equal to the prime interest rate quoted by the Bank of America on the date the payment is due, with interest being compounded on the last day of each calendar quarter. Since the SCD Patent will expire in May 2016 and the Licensed Products have yet to be commercialized, the Company does not anticipate that any amounts will be payable pursuant to the SCD Patent license agreement. |
GEOGRAPHIC INFORMATION
GEOGRAPHIC INFORMATION | 12 Months Ended |
Dec. 31, 2015 | |
Segment Reporting [Abstract] | |
GEOGRAPHIC INFORMATION | NOTE 11—GEOGRAPHIC INFORMATION For the years ended December 31, 2015 and 2014, the Company earned revenue from countries outside of the United States as outlined in the table below. The Company did not have any significant currency translation or foreign transaction adjustments during the years ended December 31, 2015 and 2014. Country Sales year ended December 31, 2015 % of Total Revenue year ended December 31, 2015 Sales year ended December 31, 2014 % of Total Revenue year ended December 31, 2014 Japan $ 194,142 33 % $ 179,570 36 % Taiwan 277,637 47 % 193,552 39 % South Korea 39,660 7 % 45,312 9 % The Company did not have any significant currency translation or foreign transaction adjustments during the years ended December 31, 2015 and 2014. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Dec. 31, 2015 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | NOTE 12—SUBSEQUENT EVENTS Subsequent to the year ended December 31, 2015, the Company issued the following: Notes Issued after December 31, 2015 Principal Annual Term of Notes Conversion Convertible notes(1) $ 749,009 10% Due on Demand up to 2 Years $ 3.60 Convertible notes(2) 490,110 10% 2 years $ 4.50 Promissory note 250,000 11% 6 months — Promissory note(1) 833,335 11% Due on Demand — Promissory notes—related party(1) 263,843 11% Due on Demand — Promissory notes—related party 529,700 10%~11% Due on Demand up to 2 Years — Total $ 3,115,997 (1) Refinancings of prior notes already outstanding. (2) Includes mandatory conversion at the time of an initial public offering at a conversion price equal to 80% of the initial public offering price. Subsequent to the year ended December 31, 2015, the Company issued the following: Common Shares Issued after Principal Number of Common shares $ 1,700,000 377,778 Common shares—related party 99,999 22,222 Total $ 1,799,999 400,000 Secured Loans after December 31, 2015 Principal Annual Term of Loans Secured loans $ 1,295,000 10 % Earlier of closing of new debt financing or May 1, 2017 Total $ 1,295,000 On May 1, 2016, the SCD Patent expired and subsequently, the license agreement has terminated. Since the SCD Patent is expired, competitors with more resources than us may develop similar products which may subject our product to greater competition than we expect and reduce our ability to generate revenue from our product candidate, possibly materially. These circumstances may also impair our ability to obtain license partners or other international commercialization opportunities on terms acceptable to us, if at all. Although the SCD patent is expired, we will continue to seek market exclusivity protection for the SCD treatment by way of our orphan designation which, if the product is approved, will grant us seven years market exclusivity. In addition, under the Title I of the Drug Price Competition and Patent Term Resolution Act or the Hatch/Waxman Act, we may be eligible for three-year period market exclusivity if approved by the FDA. The FDA may not agree that our product is entitled to data exclusivity under the Hatch/Waxman Act and, if granted, data exclusivity protection under the Hatch/Waxman Act will expire three years after our product is approved. With the termination of the license agreement, we will no longer be bound by the terms of the agreement which include but are not limited to paying royalties. The royalties were equal to 4.5% of net sales of Licensed Products in the United States until lifetime royalty payments made to the licensor total $100,000, at which time the royalty rate will decrease to 2.5% of net sales of the Licensed Products. |
SUMMARY OF SIGNIFICANT ACCOUN19
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
Basis of presentation | Basis of presentation |
Going concern | Going concern |
Principles of consolidation | Principles of consolidation |
Estimates | Estimates The warrants issued by the Company in a private placement in September 2013 and replacement warrants issued in June 2014 contain non-standard anti- dilution protection and, consequently, are being accounted for as liabilities that are remeasured to fair market value at each reporting period (Note 7). In addition, the remaining initial private placement warrants may now utilize a cashless exercise feature since the shares associated with them were not registered by the one-year anniversary of their issue. These warrants have now been reclassified from liability classified warrants to warrant derivative liabilities and to continue to be remeasured at fair value each reporting period. The initial value as well as the fair value of all such warrants were determined using a Binomial Monte-Carlo Cliquet (aka Ratchet) Option Pricing Model. The model is similar to traditional Black-Scholes-type option pricing models except that the exercise price resets at certain dates in the future. Actual results could differ from those estimates. |
Cash and cash equivalents | Cash and cash equivalents |
Inventories | Inventories All of the raw material purchases during the year ended December 31, 2015 and 2014 was from one vendor. The below table presents inventory by category: December 31, Inventory by category 2015 2014 Raw materials and components $ — $ 43,700 Work-in-process 45,355 27,665 Finished goods 173,808 179,048 Total $ 219,163 $ 250,413 |
Prepaid expenses and other current assets | Prepaid expenses and other current assets —Prepaid expenses and other current assets consisted of the following at December 31, 2015 and 2014: December 31, December 31, Prepaid insurance $ 97,708 $ 86,061 Other prepaid expenses and current assets 33,405 43,493 $ 131,113 $ 129,554 |
Deposits | Deposits |
Revenue recognition | Revenue recognition With prior written approval of the Company, in certain situations, product is returnable only by its direct customers for a returned goods credit, for product that is expired, damaged in transit, or which is discontinued, withdrawn or recalled. The Company estimates its sales returns based upon its prior sales and return history and accrues a sales return allowance at the time of sale. Historically, sales returns have been immaterial. The Company pays royalties on an annual basis based on existing license arrangements. These royalties are recognized as cost of goods sold upon sale of the products. |
Allowance for doubtful accounts | Allowance for doubtful accounts |
Advertising cost | Advertising cost |
Property and equipment | Property and equipment |
Intangibles | Intangibles |
Impairment of long-lived assets | Impairment of long-lived assets If the Company determines that the carrying values of long-lived assets may not be recoverable based upon the existence of one or more indicators of impairment, the Company performs an undiscounted cash flow analysis to determine if impairment exists. If impairment exists, the Company measures the impairment based on the difference between the asset's carrying amount and its fair value, and the impairment is charged to consolidated statement of comprehensive loss in the period in which the long-lived asset impairment is determined to have occurred. The Company has determined that an impairment of the carrying value of its long-lived assets existed at December 31, 2015 (Note 4) and no impairment existed at December 31, 2014. |
Research and development | Research and development |
Share-based compensation | Share-based compensation |
Income taxes | Income taxes For balance sheet presentation, current deferred tax assets and liabilities within each tax jurisdiction have been offset and presented as a single amount and non-current deferred tax assets and liabilities within each tax jurisdiction have been offset and presented as a single amount. When tax returns are filed, it is highly probable that some positions taken would be sustained upon examination by the taxing authorities, while others are subject to uncertainty about the merits of the position taken or the amount of the position that would be ultimately sustained. The benefit of a tax position is recognized in the financial statements in the period during which, based on all available evidence, management believes it is more likely than not that the position will be sustained upon examination, including the resolution of appeals or litigation processes, if any. Tax positions taken are not offset or aggregated with other positions. Tax positions that meet the more- likely-than-not recognition threshold are measured as the largest amount of tax benefit that is more than 50 percent likely of being realized upon settlement with the applicable taxing authority. The portion of the benefits associated with tax positions taken that exceeds the amount measured as described above is reflected as a liability for unrecognized tax benefits along with any associated interest and penalties that would be payable to the taxing authorities upon examination. As of December 31, 2015, the Company had no unrecognized tax benefits, and the Company had no positions which, in the opinion of management, would be reversed if challenged by a taxing authority. In the event the Company is assessed interest and/or penalties, such amounts will be classified as income tax expense in the financial statements. As of December 31, 2015, all federal tax returns since 2012 and state tax returns since 2011 are still subject to adjustment upon audit. No tax returns are currently being examined by taxing authorities. |
Comprehensive income (loss) | Comprehensive income (loss) |
Marketable securities | Marketable securities In July 2013, based on an increase in market value of CellSeed shares, Mitsubishi UFJ Capital III Limited Partnership (Mitsubishi) released to the Company 34,300 shares of CellSeed stock. This was part of the 73,550 shares of CellSeed stock held by Mitsubishi as collateral on a $500,000 convertible note issued to Mitsubishi which is due in 2016 ("the Mitsubishi note"). The Mitsubishi note is now secured by the remaining 39,250 shares of CellSeed stock held by Mitsubishi as collateral. During the fourth quarter of 2015, the Company sold 9,300 of the shares released from Mitsubishi in open market transactions for $71,517. The remaining 39,250 shares of CellSeed stock are pledged to secure the Mitsubishi note and are classified as marketable securities, pledged to creditor. |
Gain on derecognition of accounts payable and settlement of litigation | Gain on derecognition of accounts payable and settlement of litigation |
Foreign Currency Translation | Foreign Currency Translation |
Financial Instruments | Financial Instruments |
Fair value measurements | Fair value measurements Level 1: Inputs to the valuation methodology are unadjusted quoted prices for identical assets or liabilities in active markets that the Company has the ability to access. Level 2: Inputs to the valuation methodology include: • Quoted prices for similar assets or liabilities in active markets; • Quoted prices for identical or similar assets or liabilities in inactive markets; • Inputs other than quoted prices that are observable for the asset or liability; • Inputs that are derived principally from or corroborated by observable market data by correlation or other means. If the asset or liability has a specified (contractual) term, the Level 2 inputs must be observable for substantially the full term of the asset or liability. Level 3: Inputs to the valuation methodology are unobservable and significant to the fair value measurement. The asset's or liability's fair value measurement level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Valuation techniques used need to maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value assigned to marketable securities is determined by obtaining quoted prices on nationally recognized securities exchanges, and are classified as Level 1 investments at December 31, 2015 and 2014. The fair value of the Company's debt instruments is not materially different from their carrying values as presented. The fair value of the Company's convertible debt instruments was determined based on Level 2 inputs. The carrying value of the debt was discounted based on allocating proceeds to other financial instruments within the arrangement as discussed in Note 6. The Company issued stock purchase warrants in conjunction with its September 2013 private placement and issued replacement warrants upon the exercise of certain of such warrants in June 2014 (see Note 1 and Note 7). Such warrants and replacement warrants contain non-standard anti-dilution protection, and consequently, are accounted for as liabilities measured at fair value on a recurring basis, whose fair value is determined using Level 3 inputs. In addition, the remaining initial private placement warrants may now utilize a cashless exercise feature since the shares associated with them were not registered by the one-year anniversary of their issue. These warrants have now been reclassified from liability classified warrants to warrant derivative liabilities and continue to be remeasured at fair value each reporting period. The Level 3 inputs in the valuation of warrants include expected term and expected volatility. The following tables present the activity for those items measured at fair value on a recurring basis using Level 3 inputs during 2015 and 2014: Year ended December 31, Liability Classified Warrants—Stock Purchase Warrants 2015 2014 Balance, beginning of period $ 3,206,000 $ 6,517,000 Fair value at issuance date — 3,523,000 Settlement of liability associated with warrants exercised — (1,752,744 ) Reclassification to warrant derivative liabilities (2,545,000 ) (7,068,000 ) Reduction of the warrants exercised to intrinsic value included in the statement of comprehensive loss — (1,770,256 ) Change in fair value included in the statement of comprehensive loss (661,000 ) 3,757,000 Balance, end of period $ — $ 3,206,000 Year ended December 31, Warrant Derivative Liabilities—Stock Purchase Warrants 2015 2014 Balance, beginning of period $ 6,520,000 $ — Reclassification from liability classified warrants 2,545,000 7,068,000 Change in fair value included in the statement of comprehensive loss (1,202,000 ) (548,000 ) Balance, end of period $ 7,863,000 $ 6,520,000 The value of the liability classified warrants , the value of warrant derivative liability and the change in fair value of the liability classified warrants and warrant derivative liability were determined using a Binomial Monte-Carlo Cliquet (aka Ratchet) Option Pricing Model. The model is similar to traditional Black-Scholes-type option pricing models except that the exercise price resets at certain dates in the future. The values as of December 31, 2015, December 31, 2014, December 31, 2013 and the initial value as of September 11, 2013 were calculated based on the following assumptions: December 31, 2015 December 31, 2014 December 31, 2013 Initial Value Stock price $ 4.70 $ 4.90 $ 3.60 $ 3.60 Risk-free interest rate 1.23 % 1.38 % 1.75 % 1.72 % Expected volatility (peer group) 64.10 % 71.50 % 63.20 % 72.40 % Expected life (in years) 2.70 3.70 4.70 5.00 Expected dividend yield — — — — Number outstanding 3,320,501 3,320,501 3,320,501 3,320,501 Balance, end of period: Liability classified warrants $ — $ 3,206,000 $ 6,517,000 $ 7,541,000 Warrant derivative liabilities $ 7,863,000 $ 6,520,000 $ — $ — |
Debt and Related Party Debt | Debt and Related Party Debt Debt with Conversion and Other Options Type of Loan Term of Loan Stated Annual Interest Rate Original Loan Principal Amount Conversion Rate Beneficial Conversion Discount Amount Warrants Issued with Notes Exercise Price Warrant FMV Discount Amount Effective Interest Rate Including Discounts 2014 convertible notes payable 6 mo. ~ 2 years 10 % $ 3,096,266 $3.05 ~ $3.60 $ 1,392,387 50,000 $ 3.50 $ 126,732 28% ~ 100% 2015 convertible notes payable Due on demand ~ 2 years 10 % 4,051,022 $3.50 ~ $4.50 1,388,201 110,417 $ 4.90 220,071 14% ~ 109% Total $ 7,147,288 $ 2,780,588 160,417 $ 346,803 Related party notes are disclosed as separate line items in the Company's balance sheet presentation. |
Net loss per share | Net loss per share "Earnings per Share, |
Recent accounting pronouncements | Recent accounting pronouncements Interest—Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issuance Costs transition, an entity is required to comply with the applicable disclosures for a change in an accounting principle. These disclosures include the nature of and reason for the change in accounting principle, the transition method, a description of the prior-period information that has been retrospectively adjusted, and the effect of the change on the financial statement line items (that is, the debt issuance cost asset and the debt liability). The adoption of the amendments in this Update is not expected to have material impact on the Company's consolidated financial position or results of operations. In July 2015, the FASB issued ASU No. 2015-11, Simplifying the Measurement of Inventory , to simplify the measurement of inventory, redefining measurement from lower of cost or market to lower of cost and net realizable value. The amendments in this Update require an entity using the first-in, first-out (FIFO) or average cost method of measuring inventory to measure inventory at the lower of cost and net realizable value, defined as the estimated selling prices in the ordinary course of business less reasonably predictable costs of completion, disposal, and transportation. The amendments in this Update should be applied prospectively, and are effective for the Company for fiscal years beginning after December 15, 2016, including interim periods within those years. The adoption of the amendments in this Update is not expected to have material impact on the Company's consolidated financial position or results of operations. In January 2016, the FASB issued ASU No. 2016-01, Recognition and Measurement of Financial Assets and Financial Liabilities . The amendments applicable to the Company in this Update (1) supersede the guidance to classify equity securities, except equity method securities, with readily determinable fair values into trading or available-for-sale categories and require equity securities to be measured at fair value with changes in the fair value recognized through net income, (2) allow equity investments that do not have readily determinable fair values to be remeasured at fair value either upon the occurrence of an observable price change or upon identification of an impairment, (3) require assessment for impairment of equity investments without readily determinable fair values qualitatively at each reporting period, (4) eliminate the requirement to disclose the methods and significant assumptions used in calculating the fair value of financial instruments required to be disclosed for financial instruments measured at amortized cost on the balance sheet, (5) require public business entities to use the exit price notion when measuring the fair value of financial instruments for disclosure purposes, (6) require separate presentation of financial assets and financial liabilities by measurement category and form of financial asset (that is, securities or loans and receivables) on the balance sheet or the accompanying notes to the financial statements, (7) clarify that an entity should evaluate the need for a valuation allowance on a deferred tax asset related to available-for-sale securities in combination with the entity's other deferred tax assets. The amendments in this Update are effective for the Company for fiscal years beginning after December 15, 2017, including interim periods within those years. The amendments should be applied by means of a cumulative-effect adjustment to the balance sheet as of the beginning of the fiscal year of adoption. The amendments related to equity securities without readily determinable fair values (including disclosure requirements) should be applied prospectively to equity investments that exist as of the date of adoption of the Update. The impact of the adoption of the amendments in this Update will depend on the amount of equity securities and financial instruments subject to the amendments in this Update held by the Company at the time of adoption. In February 2016, the FASB issued ASU No. 2016-02, Leases. In March 2016, the FASB issued ASU 2016-09, Compensation—Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting . The amendments in this Update simplify the accounting for share-based payment award transactions including: income tax consequences, classification of awards as either equity or liabilities and classification on the statement of cash flows. This Update is effective for annual periods beginning after December 15, 2016, including interim periods within those annual periods. Early adoption is permitted. The Company is currently in the process of evaluating this Update. |
DESCRIPTION OF BUSINESS (Tables
DESCRIPTION OF BUSINESS (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of reconciliation of the effects of the adjustments to the previously reported balance sheet | A reconciliation of the effects of the adjustments to the previously reported consolidated balance sheet at December 31, 2014 follows: As Previously Reported Adjustment As Revised Warrant derivative liabilities 5,641,000 879,000 6,520,000 Total liabilities 22,963,954 879,000 23,842,954 Additional paid in capital 50,479,843 588,834 51,068,677 Accumulated deficit (70,616,002 ) (1,467,834 ) (72,083,836 ) Total stockholder's deficit (20,299,662 ) (879,000 ) (21,178,662 ) |
Schedule of reconciliation of the effect of the adjustments to the previously reported statement of operations | A reconciliation of the effect of the adjustments to the previously reported consolidated statement of comprehensive loss for the year ended December 31, 2014 follows: As Previously Reported Adjustment As Revised General and adminstrative 11,904,092 651,174 12,555,266 Loss from operations (14,305,569 ) (651,174 ) (14,956,743 ) Change in fair value of warrant derivative liabilities 474,000 74,000 548,000 Loss before income taxes (20,813,475 ) (941,174 ) (21,754,649 ) |
Schedule of A reconciliation of the effect of the adjustments to the previously reported statement of cash flows | A reconciliation of the effect of the adjustments to the previously reported consolidated statements of cash flows for the year ended December 31, 2014 follows: As Previously Reported Adjustment As Revised Net loss (20,817,140 ) (941,174 ) (21,758,314 ) Share-based compensation 5,870,638 651,174 6,521,812 Change in fair value of warrant derivative liabilities (474,000 ) (74,000 ) (548,000 ) |
SUMMARY OF SIGNIFICANT ACCOUN21
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
Schedule of inventory | All of the raw material purchases during the year ended December 31, 2015 and 2014 was from one vendor. The below table presents inventory by category: December 31, Inventory by category 2015 2014 Raw materials and components $ — $ 43,700 Work-in-process 45,355 27,665 Finished goods 173,808 179,048 Total $ 219,163 $ 250,413 |
Schedule of prepaid expenses and other current assets | Prepaid expenses and other current assets consisted of the following at December 31, 2015 and 2014: December 31, December 31, Prepaid insurance $ 97,708 $ 86,061 Other prepaid expenses and current assets 33,405 43,493 $ 131,113 $ 129,554 |
Schedule of changes in fair value of Level 3 liabilities | The following tables present the activity for those items measured at fair value on a recurring basis using Level 3 inputs during 2015 and 2014: Year ended December 31, Liability Classified Warrants—Stock Purchase Warrants 2015 2014 Balance, beginning of period $ 3,206,000 $ 6,517,000 Fair value at issuance date — 3,523,000 Settlement of liability associated with warrants exercised — (1,752,744 ) Reclassification to warrant derivative liabilities (2,545,000 ) (7,068,000 ) Reduction of the warrants exercised to intrinsic value included in the statement of comprehensive loss — (1,770,256 ) Change in fair value included in the statement of comprehensive loss (661,000 ) 3,757,000 Balance, end of period $ — $ 3,206,000 Year ended December 31, Warrant Derivative Liabilities—Stock Purchase Warrants 2015 2014 Balance, beginning of period $ 6,520,000 $ — Reclassification from liability classified warrants 2,545,000 7,068,000 Change in fair value included in the statement of comprehensive loss (1,202,000 ) (548,000 ) Balance, end of period $ 7,863,000 $ 6,520,000 |
Schedule of valuation assumptions for warrants | The values as of December 31, 2015, December 31, 2014, December 31, 2013 and the initial value as of September 11, 2013 were calculated based on the following assumptions: December 31, 2015 December 31, 2014 December 31, 2013 Initial Value Stock price $ 4.70 $ 4.90 $ 3.60 $ 3.60 Risk-free interest rate 1.23 % 1.38 % 1.75 % 1.72 % Expected volatility (peer group) 64.10 % 71.50 % 63.20 % 72.40 % Expected life (in years) 2.70 3.70 4.70 5.00 Expected dividend yield — — — — Number outstanding 3,320,501 3,320,501 3,320,501 3,320,501 Balance, end of period: Liability classified warrants $ — $ 3,206,000 $ 6,517,000 $ 7,541,000 Warrant derivative liabilities $ 7,863,000 $ 6,520,000 $ — $ — |
Schedule of convertible notes payable | The following table presents the effective interest rates on the original loan principal amount for loans originated in the respective periods that either had a beneficial conversion interest or an attached warrant: Type of Loan Term of Loan Stated Annual Interest Rate Original Loan Principal Amount Conversion Rate Beneficial Conversion Discount Amount Warrants Issued with Notes Exercise Price Warrant FMV Discount Amount Effective Interest Rate Including Discounts 2014 convertible notes payable 6 mo. ~ 2 years 10 % $ 3,096,266 $3.05 ~ $3.60 $ 1,392,387 50,000 $ 3.50 $ 126,732 28% ~ 100% 2015 convertible notes payable Due on demand ~ 2 years 10 % 4,051,022 $3.50 ~ $4.50 1,388,201 110,417 $ 4.90 220,071 14% ~ 109% Total $ 7,147,288 $ 2,780,588 160,417 $ 346,803 |
PROPERTY AND EQUIPMENT (Tables)
PROPERTY AND EQUIPMENT (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Property, Plant and Equipment [Abstract] | |
Schedule of property and equipment | Property and equipment consisted of the following at: December 31, 2015 December 31, 2014 Equipment $ 164,931 $ 160,201 Leasehold improvements 30,579 30,579 Furniture and fixtures 74,682 74,683 270,192 265,463 Less: accumulated depreciation (211,965 ) (193,072 ) Total $ 58,227 $ 72,391 |
INTANGIBLE ASSETS (Tables)
INTANGIBLE ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Intangible Assets | Intangible assets, net consisted of the following at: December 31, 2015 December 31, 2014 License fees and patent filing costs $ 2,000,000 $ 2,000,000 Less: accumulated amortization (1,321,429 ) (1,107,143 ) Impairment loss (678,571 ) — Intangible assets, net $ — $ 892,857 |
ACCOUNTS PAYABLE AND ACCRUED 24
ACCOUNTS PAYABLE AND ACCRUED EXPENSES (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Payables and Accruals [Abstract] | |
Schedule of accounts payable and accrued expenses | Accounts payable and accrued expenses consisted of the following at: December 31, 2015 December 31, 2014 Accounts payable Clinical and regulatory expenses $ 322,193 $ 266,537 Legal expenses 242,384 176,691 Other vendors 959,333 774,444 Subtotal 1,523,910 1,217,672 Accrued interest payable, related parties 176,940 110,200 Accrued interest payable 1,586,472 761,682 Accrued expenses 201,506 220,200 Deferred salary 291,666 291,666 Total accounts payable and accrued expenses $ 3,780,494 $ 2,601,420 |
NOTES PAYABLE (Tables)
NOTES PAYABLE (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Debt Disclosure [Abstract] | |
Schedule of notes payable | Notes payable consisted of the following at December 31, 2015: Year Issued Interest Rate Range Term of Notes Conversion Price Principal Outstanding December 31, 2015 Discount Amount December 31, 2015 Carrying Amount December 31 2015 Shares Underlying Notes December 31, 2015 Principal Outstanding December 31, 2014 Discount Amount December 31, 2014 Carrying Amount December 31, 2014 Shares Underlying Notes December 31, 2014 Notes payable 2014 11% Due on — 1,446,950 — 1,446,950 — 1,446,950 — 1,446,950 — 2015 11% Due on — 2,379,799 — 2,379,799 — — — — — ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ $ 4,656,749 — $ 4,656,749 — $ 2,476,950 $ — $ 2,476,950 — ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Current $ 4,656,749 $ — $ 4,656,749 — $ 1,643,615 $ — $ 1,643,615 — Long-term $ — $ — $ — — $ 833,335 $ — $ 833,335 — Notes payable—related party 2013 8% Due on demand — 50,000 — 50,000 — 50,000 — 50,000 — 2014 11% Due on — 240,308 — 240,308 — 252,165 — 252,165 — 2015 10% ~ 11% Due on — 1,849,266 — 1,849,266 — — — — — ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ $ 2,766,304 $ — $ 2,766,304 — $ 958,895 $ — $ 958,895 — ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Current $ 2,766,304 $ — $ 2,766,304 — $ 825,562 $ — $ 825,562 — Long-term $ — $ — $ — — $ 133,333 $ — $ 133,333 — Convertible notes payable 2011 10% 5 years $3.05 500,000 — 500,000 163,809 500,000 — 500,000 163,809 2013 10% 2 years $3.60 525,257 — 525,257 185,553 2,463,299 18,750 2,444,549 834,667 2014 10% Due on $3.05 ~$7.00 4,378,563 353,700 4,024,863 1,120,470 4,939,773 846,613 4,093,160 1,241,241 2015 10% Due on $3.50 ~$7.00 5,681,166 526,066 5,155,100 1,517,996 — — — — ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ $ 11,086,986 $ 879,766 $ 10,207,220 2,988,484 $ 7,977,072 $ 868,558 $ 7,108,514 2,263,965 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Current $ 6,358,698 $ 358,351 $ 6,000,347 1,762,849 $ 3,478,904 $ 21,945 $ 3,456,959 1,156,050 Long-term $ 4,728,288 $ 521,415 $ 4,206,873 1,225,635 $ 4,498,168 $ 846,613 $ 3,651,555 1,107,915 Convertible notes payable—related party 2014 10% 2 years $7.00 — — — — 200,000 — 200,000 30,187 2015 10% 2 years $4.50 320,000 — 320,000 72,354 — — — — ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ $ 618,000 $ — $ 618,000 180,859 $ 573,000 $ — $ 573,000 151,648 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Current $ 298,000 $ — $ 298,000 108,505 $ 373,000 $ — $ 373,000 121,461 Long-term $ 320,000 $ — $ 320,000 72,354 $ 200,000 $ — $ 200,000 30,187 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Grand Total $ 19,128,039 $ 879,766 $ 18,248,273 3,169,343 $ 11,985,917 $ 868,558 $ 11,117,359 2,415,613 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ |
Schedule of contractual principal payments of loans and notes payable | Contractual principal payments due on notes payable are as follows: Year Ending at December 31, 2015 2016 $ 14,079,751 2017 5,048,288 ​ ​ ​ ​ ​ Total $ 19,128,039 |
Schedule of fair value assumptions for warrants issued in conjunction with notes | The fair value of the warrants issued in conjunction with notes was determined using the Black-Scholes-Merton option pricing model with the following inputs for the years ended: 2015 2014 Stock price $ 4.50 $ 4.90 Exercise price $ 4.90 $ 3.50 Term 5 years 5 years Risk-free interest rate 1.57 % 1.66 % Expected dividend yield — — Expected volatility 67.30 % 70.10 |
STOCKHOLDERS' EQUITY (DEFICIT)
STOCKHOLDERS' EQUITY (DEFICIT) (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Stockholders' Equity Note [Abstract] | |
Schedule of outstanding warrants | A summary of outstanding warrants as of December 31, 2015 and 2014 is presented below. Year ended December 31, 2015 Year ended December 31, 2014 Warrants outstanding, beginning of period 5,101,450 6,279,296 Granted 110,417 1,145,465 Exercised (148,256 ) (1,254,621 ) Cancelled, forfeited and expired (1,532,693 ) (1,068,690 ) Warrants outstanding, end of period 3,530,918 5,101,450 |
Schedule of warrant exercise price | A summary of outstanding warrants by year issued and exercise price as of December 31, 2015 is presented below. Outstanding Exercisable Exercise Price Number of Warrants Issued Weighted Average Remaining Contractual Life (Years) Weighted Average Exercise Price Total Weighted Average Exercise Price During 2013 $3.30 50,000 2.33 $ 3.30 50,000 $ 3.30 $3.50 2,225,036 2.70 $ 3.50 2,225,036 $ 3.50 2013 total 2,275,036 2,275,036 During 2014 $3.50 1,145,465 2.73 $ 3.50 1,145,465 $ 3.50 2014 total 1,145,465 1,145,465 During 2015 $4.90 110,417 4.18 $ 4.90 110,417 $ 4.90 Total 3,530,918 3,530,918 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ |
Schedule of valuation assumptions | The following table presents the assumptions used on recent dates on which options were granted by the Board of Directors. July 17, 2014 May 8, 2014 February 26, 2014 Stock price $ 5.10 $ 4.90 $ 3.60 Exercise price $ 5.10 $ 4.90 $ 3.60 Term 10 years 10 years 10 years Risk-Free Interest Rate 2.47 % 2.61 % 2.67 % Dividend Yield 0.00 % 0.00 % 0.00 % Volatility 77.90 % 75.50 % 76.60 % |
Schedule of outstanding options | A summary of the Company's stock option activity for the years ended December 31, 2015 and 2014 is presented below. Prior Plan December 31, 2015 December 31, 2014 Number of Options Weighted- Average Exercise Price Number of Options Weighted- Average Exercise Price Number of Options Weighted- Average Exercise Price Options outstanding, beginning of period 11,795 $ 3.05 5,669,000 $ 3.68 4,504,000 $ 3.58 Granted or deemed issued — — — — 1,180,000 $ 4.06 Exercised — — (2,000 ) $ 3.60 — — Cancelled, forfeited and expired (11,795 ) $ 3.05 (913,665 ) $ 4.05 (15,000 ) $ 3.60 Options outstanding, end of period — — 4,753,335 $ 3.60 5,669,000 $ 3.68 Options exercisable at end of year — — 4,379,335 $ 3.60 2,855,251 $ 3.55 Options available for future grant — — 4,246,665 — 3,331,000 — |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | |
Schedule of provision (benefit) for income taxes | The provision for income taxes consists of the following for the years ended December 31: 2015 2014 Current U.S. $ 2,400 $ 2,500 International 1,164 1,165 Deferred U.S. — — International — — $ 3,564 $ 3,665 |
Schedule of deferred tax assets and liabilities | Deferred tax assets consist of the following as of December 31, 2015 and 2014: 2015 2014 Net operating loss carryforward $ 16,650,797 $ 14,354,064 General business tax credit 6,510,162 5,720,604 Stock options 6,271,690 4,843,871 Charitable contribution 79,944 81,434 Accrued expenses 290,083 171,325 Deferred compensation — — Other 444,029 126,983 Total gross deferred tax assets 30,247,605 25,298,281 Less valuation allowance (30,116,742 ) (25,184,004 ) Net deferred tax assets $ 130,863 $ 114,277 |
Schedule of income tax provision computed using the statutory federal tax rate | Deferred tax liabilities consist of the following as of December 31, 2015 and 2014: 2015 2014 Unrealized gain on foreign exchange translation and others $ (99,228 ) $ (98,825 ) Unrealized gain on securities available-for-sale (31,635 ) (15,452 ) Total deferred tax liability $ (130,863 ) $ (114,277 ) |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of future minimum lease payments | Future minimum lease payments under the agreements are as follows: Year Amount 2016 $ 552,696 2017 522,555 2018 490,829 2019 123,875 Total $ 1,689,955 |
RELATED PARTY TRANSACTIONS (Tab
RELATED PARTY TRANSACTIONS (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Related Party Transactions [Abstract] | |
Schedule of related parties outstanding loans | The following table sets forth information relating to the Company's loans from related persons outstanding as of December 31, 2015. Class Lender Annual Interest Rate Date of Loan Term of Loan Principal Amount Outstanding at December 31, 2015 Highest Principal Outstanding Amount of Principal Repaid Amount of Interest Paid Conversion Rate Shares Underlying Notes at December 31, 2015 Notes payable to related parties—current: Hope Hospice(1) 8 % 1/17/2012 Due on demand $ 200,000 $ 200,000 $ — $ 8,000 $ — — Hope Hospice(1) 8 % 6/14/2012 Due on demand 200,000 200,000 — 8,000 — — Hope Hospice(1) 8 % 6/21/2012 Due on demand 100,000 100,000 — 4,000 — — Yutaka Niihara(2)(4) 10 % 12/5/2012 Due on demand 126,730 1,213,700 1,086,970 56,722 — — Hope Hospice(1) 8 % 2/11/2013 Due on demand 50,000 50,000 — 2,000 — — Lan T. Tran(2) 11 % 2/10/2014 2 years(3) 106,976 106,976 — — — — Hideki & Eiko Uehara(5) 11 % 2/15/2014 2 years 133,333 133,333 — — — — Hope Hospice(1) 10 % 1/7/2015 2 years(3) 100,000 100,000 — — — — James Lee(5) 10 % 1/26/2015 2 years(3) 50,000 50,000 — — — — Hope Hospice(1) 10 % 1/29/2015 2 years(3) 30,000 30,000 — — — — Yutaka Niihara(2)(4) 10 % 1/29/2015 Due on demand — 20,000 20,000 773 Lan T. Tran(2) 10 % 2/9/2015 2 years(3) 10,000 10,000 — — — — Charles Stark(2) 10 % 2/10/2015 2 years(3) 10,000 10,000 — — — — IRA Service Trust Co. FBO Peter B. Ludlum(2) 10 % 2/20/2015 2 years(3) 10,000 10,000 — — — — Cuc T. Tran(5) 11 % 3/5/2015 1 year 13,161 13,161 — — — — Yutaka Niihara(2)(4) 10 % 4/7/2015 2 years(3) 500,000 500,000 — — — — Yutaka Niihara(2)(4) 10 % 5/21/2015 Due on demand 826,105 826,105 — — — — Masaharu & Emiko Osato(4) 11 % 12/29/2015 Due on demand 300,000 300,000 — — — — Sub total $ 2,766,304 $ 3,873,275 $ 1,106,970 $ 79,495 $ — — Convertible notes payable to related parties—current: Yasushi Nagasaki(2) 10 % 6/29/2012 Due on demand $ 298,000 $ 388,800 $ 90,800 $ — $ 3.30 108,505 Sub total $ 298,000 $ 388,800 $ 90,800 $ — $ — 108,505 Non-Current, convertible notes payable to related parties: Yutaka Niihara(2)(4) 10 % 9/29/2015 2 years $ 100,000 $ 100,000 $ — $ — $ 4.50 22,794 Charles & Kimxa Stark(2) 10 % 10/1/2015 2 years 20,000 20,000 4.50 4,556 Yutaka & Soomi Niihara(2)(4) 10 % 11/16/2015 2 years 200,000 200,000 4.50 45,004 Sub total 320,000 320,000 $ — $ — $ — 72,354 Total $ 3,384,304 $ 4,582,075 $ 1,197,770 $ — $ — 180,859 (1) Dr. Niihara, who is the Company's CEO, is also the CEO of Hope International Hospice, Inc ("Hope Hospice"). (2) Officer (3) Due on Demand (4) Director (5) Family of Officer/Director Class Lender Annual Interest Rate Date of loan Term of Loan Principal Amount Outstanding at December 31, 2014 Highest Principal outstanding Amount of Principal Repaid Amount of Interest Paid Conversion Rate Shares Underlying Notes at December 31, 2014 Current, Promissory note payable to related parties: Hope Hospice(1) 8 % 1/17/2012 Due on demand $ 200,000 $ 200,000 $ — $ 16,000 — — Hope Hospice(1) 8 % 6/14/2012 Due on demand 200,000 200,000 — 20,000 — — Hope Hospice(1) 8 % 6/21/2012 Due on demand 100,000 100,000 — 10,000 — — Yutaka Niihara(2)(4) 10 % 12/5/2012 Due on demand 156,730 1,213,700 1,056,970 60,851 — — Hope Hospice(1) 8 % 2/11/2013 Due on demand 50,000 50,000 — 4,000 — — Lan T. Tran(2) 11 % 2/10/2014 2 years(3) 106,976 106,976 — — — — Cuc T. Tran(5) 11 % 3/5/2014 1 year 11,856 11,856 — — — — Sub total $ 825,562 $ 1,882,532 $ 1,056,970 $ 110,851 — — Current, Convertible notes payable to related parties: Yasushi Nagasaki(2) 10 % 6/29/2012 Due on demand $ 373,000 $ 388,800 $ 15,800 $ 67,680 $ 3.30 121,461 Sub total $ 373,000 $ 388,800 $ 15,800 $ 67,680 — 121,461 Long-term, Promissory note payable to related parties: Hideki & Eiko Uehara(5) 11 % 2/15/2014 2 years $ 133,333 $ 133,333 $ — $ 14,697 — — Sub total $ 133,333 $ 133,333 $ — $ 14,697 — — Long-term, Convertible notes payable to related parties: Phillip M. Satow(4) 10 % 6/6/2014 2 years $ 100,000 $ 100,000 $ — $ — $ 7.00 15,103 Richard S. Pechter(5) 10 % 6/11/2014 2 years 100,000 100,000 — — $ 7.00 15,084 Sub total $ 200,000 $ 200,000 $ — $ — — 30,187 Total $ 1,531,895 $ 2,604,665 $ 1,072,770 $ 193,228 — 151,648 (1) Dr. Niihara, who is the Company's CEO, is also the CEO of Hope Hospice. (2) Officer (3) Due on Demand (4) Director (5) Family of Officer/Director |
GEOGRAPHIC INFORMATION (Tables)
GEOGRAPHIC INFORMATION (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Segment Reporting [Abstract] | |
Schedule of revenue earned from countries outside of the united states | The Company did not have any significant currency translation or foreign transaction adjustments during the years ended December 31, 2015 and 2014. Country Sales year ended December 31, 2015 % of Total Revenue year ended December 31, 2015 Sales year ended December 31, 2014 % of Total Revenue year ended December 31, 2014 Japan $ 194,142 33 % $ 179,570 36 % Taiwan 277,637 47 % 193,552 39 % South Korea 39,660 7 % 45,312 9 % |
SUBSEQUENT EVENTS (Tables)
SUBSEQUENT EVENTS (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Subsequent Events [Abstract] | |
Schedule of subsequent events notes payable | Subsequent to the year ended December 31, 2015, the Company issued the following: Notes Issued after December 31, 2015 Principal Annual Term of Notes Conversion Convertible notes(1) $ 749,009 10% Due on Demand up to 2 Years $ 3.60 Convertible notes(2) 490,110 10% 2 years $ 4.50 Promissory note 250,000 11% 6 months — Promissory note(1) 833,335 11% Due on Demand — Promissory notes—related party(1) 263,843 11% Due on Demand — Promissory notes—related party 529,700 10%~11% Due on Demand up to 2 Years — Total $ 3,115,997 (1) Refinancings of prior notes already outstanding. (2) Includes mandatory conversion at the time of an initial public offering at a conversion price equal to 80% of the initial public offering price. Subsequent to the year ended December 31, 2015, the Company issued the following: Common Shares Issued after Principal Number of Common shares $ 1,700,000 377,778 Common shares—related party 99,999 22,222 Total $ 1,799,999 400,000 Secured Loans after December 31, 2015 Principal Annual Term of Loans Secured loans $ 1,295,000 10 % Earlier of closing of new debt financing or May 1, 2017 Total $ 1,295,000 |
DESCRIPTION OF BUSINESS (Detail
DESCRIPTION OF BUSINESS (Details Narrative) - USD ($) | 3 Months Ended | 12 Months Ended | ||||
Dec. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Mar. 31, 2011 | Oct. 31, 2010 | |
Description of prior period errors | 300,000 common stock purchase warrant for the purchase of common stock issued to a certain broker as compensation for services rendered in a private placement transaction during 2013. | |||||
Stock option accounting errors | $ 3,708,801 | $ 6,521,812 | ||||
Warrant derivative liabilities | $ 6,520,000 | $ 7,863,000 | 6,520,000 | |||
Cumulative Adjustment [Member] | ||||||
Stock option accounting errors | 651,174 | |||||
Warrant derivative liabilities | 290,000 | 290,000 | ||||
Total Adjustments | 941,174 | |||||
Adjustment Applicable [Member] | ||||||
Stock option accounting errors | (99,169) | |||||
Warrant derivative liabilities | (74,000) | $ (74,000) | ||||
Total Adjustments | $ (173,169) | |||||
Emmaus Medical Japan, Inc [Member] | ||||||
Percentage of acquired interest | 3.00% | 97.00% | ||||
Aggregate formation cost | $ 52,500 | |||||
Fair value of derivative liability | $ 681,000 | |||||
Derivative liability allocated to additional paid in capital | 62,000 | |||||
Derivative liability charged as transaction cost | $ 619,000 |
DESCRIPTION OF BUSINESS (Deta33
DESCRIPTION OF BUSINESS (Details) - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 |
Warrant derivative liabilities | $ 7,863,000 | $ 6,520,000 | |
Total liabilities | 30,039,984 | 23,842,954 | |
Additional paid in capital | 51,068,677 | ||
Accumulated deficit | (84,781,809) | (72,083,836) | |
Total stockholder's deficit | $ (28,562,986) | (21,178,662) | $ (14,426,660) |
Previously Reported [Member] | |||
Warrant derivative liabilities | 5,641,000 | ||
Total liabilities | 22,963,954 | ||
Additional paid in capital | 50,479,843 | ||
Accumulated deficit | (70,616,002) | ||
Total stockholder's deficit | (20,299,662) | ||
Adjustment [Member] | |||
Warrant derivative liabilities | 879,000 | ||
Total liabilities | 879,000 | ||
Additional paid in capital | 588,834 | ||
Accumulated deficit | (1,467,834) | ||
Total stockholder's deficit | $ (879,000) |
DESCRIPTION OF BUSINESS (Deta34
DESCRIPTION OF BUSINESS (Details 1) - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
General and administrative | $ 9,419,683 | $ 12,555,266 |
Loss from operations | (11,802,582) | (14,956,743) |
Change in fair value of warrant derivative liabilities | 1,202,000 | 548,000 |
Loss before income taxes | $ (12,694,409) | (21,754,649) |
Previously Reported [Member] | ||
General and administrative | 11,904,092 | |
Loss from operations | (14,305,569) | |
Change in fair value of warrant derivative liabilities | 474,000 | |
Loss before income taxes | (20,813,475) | |
Adjustment [Member] | ||
General and administrative | 651,174 | |
Loss from operations | (651,174) | |
Change in fair value of warrant derivative liabilities | 74,000 | |
Loss before income taxes | $ (941,174) |
DESCRIPTION OF BUSINESS (Deta35
DESCRIPTION OF BUSINESS (Details 2) - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Net loss | $ (12,697,973) | $ (21,758,314) |
Share-based compensation | 3,708,801 | 6,521,812 |
Change in fair value of warrant derivative liabilities | $ (1,202,000) | (548,000) |
Previously Reported [Member] | ||
Net loss | (20,817,140) | |
Share-based compensation | 5,870,638 | |
Change in fair value of warrant derivative liabilities | (474,000) | |
Adjustment [Member] | ||
Net loss | (941,174) | |
Share-based compensation | 651,174 | |
Change in fair value of warrant derivative liabilities | $ (74,000) |
SUMMARY OF SIGNIFICANT ACCOUN36
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) | 1 Months Ended | 12 Months Ended | ||
Jan. 31, 2009USD ($)Number$ / sharesshares | Dec. 31, 2015USD ($)$ / sharesshares | Dec. 31, 2014USD ($)$ / sharesshares | Jul. 31, 2013USD ($)shares | |
Recurring net losses | $ (12,697,973) | $ (21,758,314) | ||
Advertising costs | 62,388 | 222,883 | ||
Impairment of intangible assets | $ 678,571 | $ 0 | ||
Stock pledged against note | shares | 73,550 | |||
Potentially dilutive securities outstanding | shares | 11,453,596 | 13,197,858 | ||
AFH Advisory [Member] | ||||
Gain on derecognition of amounts due to related party | $ 394,446 | |||
2011 Convertible notes payable [Member] | ||||
Convertible notes payable, carrying amount | $ 500,000 | $ 500,000 | $ 500,000 | |
Cell Seed Inc [Member] | ||||
Shares held as marketable securities | shares | 39,250 | |||
Shares originally purchased (in shares) | shares | 147,100 | |||
Investment, in dollars | $ 1,109,819 | |||
Available for sale securities, stock (in shares) | shares | 9,300 | |||
Available for sale securities, value | $ 71,517 | |||
Stock pledged against note | shares | 39,250 | 39,250 | ||
Cell Seed Inc [Member] | Japan, Yen | ||||
Investment, in yen | Number | 100,028,000 | |||
Investment, in per share | $ / shares | $ 680 | |||
Investment, closing price | $ / shares | $ 672 | $ 1,027 | ||
Minimum [Member] | ||||
Intangible assets, useful life | 3 years | |||
Maximum [Member] | ||||
Intangible assets, useful life | 7 years | |||
Furniture and Fixtures [Member] | Minimum [Member] | ||||
Useful life | 5 years | |||
Furniture and Fixtures [Member] | Maximum [Member] | ||||
Useful life | 7 years |
SUMMARY OF SIGNIFICANT ACCOUN37
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 |
Accounting Policies [Abstract] | ||
Raw materials and components | $ 43,700 | |
Work-in-process | $ 45,355 | 27,665 |
Finished goods | 173,808 | 179,048 |
Total | $ 219,163 | $ 250,413 |
SUMMARY OF SIGNIFICANT ACCOUN38
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details 1) - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 |
Accounting Policies [Abstract] | ||
Prepaid insurance | $ 97,708 | $ 86,061 |
Other prepaid expenses and current assets | 33,405 | 43,493 |
Prepaid expenses and other current assets | $ 131,113 | $ 129,554 |
SUMMARY OF SIGNIFICANT ACCOUN39
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details 2) - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Liability Classified Warrants - Stock Purchase Warrants [Member] | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Balance, beginning of period | $ 3,206,000 | $ 6,517,000 |
Fair value at issuance date | 3,523,000 | |
Settlement of liability associated with warrants exercised | (1,752,744) | |
Reclassification to warrant derivative liabilities | (2,545,000) | (7,068,000) |
Reduction of the warrants exercised to intrinsic value included in the statement of comprehensive loss | (1,770,256) | |
Change in fair value included in the statement of comprehensive loss | (661,000) | 3,757,000 |
Balance, end of period | 3,206,000 | |
Warrant Derivative Liabilities - Stock Purchase Warrants [Member] | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Balance, beginning of period | 6,520,000 | |
Reclassification from liability classified warrants | 2,545,000 | 7,068,000 |
Change in fair value included in the statement of comprehensive loss | (1,202,000) | (548,000) |
Balance, end of period | $ 7,863,000 | $ 6,520,000 |
SUMMARY OF SIGNIFICANT ACCOUN40
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details 3) - USD ($) | Sep. 11, 2013 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 |
Stock price | $ 4.90 | |||
Risk free interest rate | 1.57% | 1.66% | ||
Expected volatility (peer group) | 67.30% | 70.10% | ||
Expected life (in years) | 5 years | 5 years | ||
Balance, end of period: | ||||
Liability classified warrants | $ 3,206,000 | |||
Warrant derivative liabilities | $ 7,863,000 | $ 6,520,000 | ||
Warrants [Member] | ||||
Stock price | $ 3.60 | $ 4.70 | $ 4.90 | $ 3.60 |
Risk free interest rate | 1.72% | 1.23% | 1.38% | 1.75% |
Expected volatility (peer group) | 72.40% | 64.10% | 71.50% | 63.20% |
Expected life (in years) | 5 years | 2 years 8 months 12 days | 3 years 8 months 12 days | 4 years 8 months 12 days |
Expected dividend yield | ||||
Number outstanding | 3,320,501 | 3,320,501 | 3,320,501 | 3,320,501 |
Balance, end of period: | ||||
Liability classified warrants | $ 7,541,000 | $ 3,206,000 | $ 6,517,000 | |
Warrant derivative liabilities | $ 7,863,000 | $ 6,520,000 |
SUMMARY OF SIGNIFICANT ACCOUN41
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details 4) | 12 Months Ended |
Dec. 31, 2015USD ($)$ / shares$ / Warrantsshares | |
Minimum [Member] | |
Conversion Rate (in dollars per share) | $ / shares | $ 3.05 |
Maximum [Member] | |
Conversion Rate (in dollars per share) | $ / shares | $ 3.60 |
2015 Convertible notes payable - related party [Member] | |
Term of Loans | Due on demand ~ 2 years |
Stated Annual Interest Rate | 10.00% |
Original Loan Principal Amount | $ 4,051,022 |
Beneficial Conversion Discount Amount | $ 1,388,201 |
Warrants Issued with Notes | shares | 110,417 |
Warrant FMV Discount Amount | $ 220,071 |
Excrcise Price (in dollars per share) | $ / Warrants | 4.90 |
2015 Convertible notes payable - related party [Member] | Minimum [Member] | |
Conversion Rate (in dollars per share) | $ / shares | $ 3.50 |
Effective Interest Rate Including Discounts | 14.00% |
2015 Convertible notes payable - related party [Member] | Maximum [Member] | |
Conversion Rate (in dollars per share) | $ / shares | $ 4.50 |
Effective Interest Rate Including Discounts | 109.00% |
2014 Convertible notes payable - related party [Member] | |
Term of Loans | 6 mo. ~ 2 years |
Stated Annual Interest Rate | 10.00% |
Original Loan Principal Amount | $ 3,096,266 |
Beneficial Conversion Discount Amount | $ 1,392,387 |
Warrants Issued with Notes | shares | 50,000 |
Warrant FMV Discount Amount | $ 126,732 |
Excrcise Price (in dollars per share) | $ / Warrants | 3.50 |
2014 Convertible notes payable - related party [Member] | Minimum [Member] | |
Conversion Rate (in dollars per share) | $ / shares | $ 3.05 |
Effective Interest Rate Including Discounts | 28.00% |
2014 Convertible notes payable - related party [Member] | Maximum [Member] | |
Conversion Rate (in dollars per share) | $ / shares | $ 3.60 |
Effective Interest Rate Including Discounts | 100.00% |
Notes payable and convertible notes payable - related party [Member] | |
Original Loan Principal Amount | $ 7,147,288 |
Beneficial Conversion Discount Amount | $ 2,780,588 |
Warrants Issued with Notes | shares | 160,417 |
Warrant FMV Discount Amount | $ 346,803 |
PROPERTY AND EQUIPMENT (Details
PROPERTY AND EQUIPMENT (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 18,893 | $ 16,620 |
PROPERTY AND EQUIPMENT (Detai43
PROPERTY AND EQUIPMENT (Details) - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 |
Property and equipment | ||
Property and equipment, gross | $ 270,192 | $ 265,463 |
Less: accumulated depreciation | (211,965) | (193,072) |
Property and equipment, net | 58,227 | 72,391 |
Equipment [Member] | ||
Property and equipment | ||
Property and equipment, gross | 164,931 | 160,201 |
Leasehold Improvements [Member] | ||
Property and equipment | ||
Property and equipment, gross | 30,579 | 30,579 |
Furniture and Fixtures [Member] | ||
Property and equipment | ||
Property and equipment, gross | $ 74,682 | $ 74,683 |
INTANGIBLE ASSETS (Details Narr
INTANGIBLE ASSETS (Details Narrative) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Feb. 28, 2012 | Apr. 30, 2011 | Dec. 31, 2015 | Dec. 31, 2014 | |
Amortization expense | $ 214,286 | $ 214,286 | ||
Impairment loss in terms of license fees paid | 678,571 | |||
Cell Seed Inc [Member] | ||||
Impairment loss in terms of license fees paid | $ 678,571 | |||
Individual Agreement [Member] | Cell Seed Inc [Member] | ||||
Amount paid to related party | $ 1,500,000 | |||
Joint Research And Development Agreement [Member] | Cell Seed Inc [Member] | ||||
Amount paid to related party | $ 8,500,000 |
INTANGIBLE ASSETS (Details)
INTANGIBLE ASSETS (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Intangible assets | ||
License fees and patent filing costs | $ 2,000,000 | $ 2,000,000 |
Less: accumulated amortization | (1,321,429) | (1,107,143) |
Impairment loss | $ (678,571) | |
Intangible assets, net | $ 892,857 |
ACCOUNTS PAYABLE AND ACCRUED 46
ACCOUNTS PAYABLE AND ACCRUED EXPENSES (Details) - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 |
Accounts payable | ||
Cinical and regulatory expenses | $ 322,193 | $ 266,537 |
Legal expenses | 242,384 | 176,691 |
Other vendors | 959,333 | 774,444 |
Subtotal | 1,523,910 | 1,217,672 |
Accrued interest payable, related parties | 176,940 | 110,200 |
Accrued interest payable | 1,586,472 | 761,682 |
Accrued expenses | 201,506 | 220,200 |
Deferred salary | 291,666 | 291,666 |
Total accounts payable and accrued expenses | $ 3,780,494 | $ 2,601,420 |
NOTES PAYABLE (Details Narrativ
NOTES PAYABLE (Details Narrative) - $ / shares | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Average stated interest rate | 10.00% | |
Average effective interest rate | 23.00% | 23.00% |
Description of debt conversion | Certain notes with a $4.50 or a $7.00 stated conversion price in the second year of their two year term are subject to automatic conversion into shares of our common stock at a conversion price equal to 80% of the initial public offering price at the time of a qualified public offering. | |
Minimum [Member] | ||
Conversion price | $ 3.05 | |
Maximum [Member] | ||
Conversion price | $ 3.60 | |
Warrants [Member] | ||
Simplified method | Black-Scholes-Merton option pricing model |
NOTES PAYABLE (Details)
NOTES PAYABLE (Details) | 12 Months Ended | ||
Dec. 31, 2015USD ($)Number$ / shares | Dec. 31, 2014USD ($)Number$ / shares | Jul. 31, 2013USD ($) | |
Principal Outstanding | $ 19,128,039 | $ 11,985,917 | |
Discount Amount | 879,766 | 868,558 | |
Total Carrying Amount | $ 18,248,273 | $ 11,117,359 | |
Shares Underlying Principal | Number | 3,169,343 | 2,415,613 | |
Convertible notes payable, Current | $ 6,000,347 | $ 3,456,959 | |
Convertible notes payable, Non Current | 4,206,873 | 3,651,555 | |
Notes payable, Current | 4,656,749 | 1,643,615 | |
Notes payable, Non Current | 833,335 | ||
Notes payable related parties, Current | $ 2,766,304 | 825,562 | |
Notes payable related parties, Non Current | $ 133,333 | ||
Minimum [Member] | |||
Conversion price | $ / shares | $ 3.05 | ||
Maximum [Member] | |||
Conversion price | $ / shares | $ 3.60 | ||
2010 Convertible notes payable [Member] | |||
Interest rate | 6.00% | 6.00% | |
Term of Notes | 5Â years | 5Â years | |
Conversion price | $ / shares | $ 3.05 | $ 3.05 | |
Principal Outstanding | $ 2,000 | $ 74,000 | |
Discount Amount | 3,195 | ||
Convertible notes payable, Carrying Amount | $ 2,000 | $ 70,805 | |
Shares Underlying Principal | Number | 656 | 24,248 | |
2011 Convertible notes payable [Member] | |||
Interest rate | 10.00% | 10.00% | |
Term of Notes | 5Â years | 5Â years | |
Conversion price | $ / shares | $ 3.05 | $ 3.05 | |
Principal Outstanding | $ 500,000 | $ 500,000 | |
Convertible notes payable, Carrying Amount | $ 500,000 | $ 500,000 | $ 500,000 |
Shares Underlying Principal | Number | 163,809 | 163,809 | |
2013 Convertible notes payable [Member] | |||
Interest rate | 10.00% | 10.00% | |
Term of Notes | 2Â years | 2Â years | |
Conversion price | $ / shares | $ 3.60 | $ 3.60 | |
Principal Outstanding | $ 525,257 | $ 2,463,299 | |
Discount Amount | 18,750 | ||
Convertible notes payable, Carrying Amount | $ 525,257 | $ 2,444,549 | |
Shares Underlying Principal | Number | 185,553 | 834,667 | |
2014 Convertible notes payable [Member] | |||
Interest rate | 10.00% | 10.00% | |
Term of Notes | Due on demand ~ 2Â years | Due on demand ~ 2Â years | |
Principal Outstanding | $ 4,378,563 | $ 4,939,773 | |
Discount Amount | 353,700 | 846,613 | |
Convertible notes payable, Carrying Amount | $ 4,024,863 | $ 4,093,160 | |
Shares Underlying Principal | Number | 1,120,470 | 1,241,241 | |
2014 Convertible notes payable [Member] | Minimum [Member] | |||
Conversion price | $ / shares | $ 3.05 | $ 3.05 | |
2014 Convertible notes payable [Member] | Maximum [Member] | |||
Conversion price | $ / shares | $ 7 | $ 7 | |
2015 Convertible notes payable [Member] | |||
Interest rate | 10.00% | ||
Term of Notes | Due on demand ~ 2Â years | ||
Principal Outstanding | $ 5,681,166 | ||
Discount Amount | 526,066 | ||
Convertible notes payable, Carrying Amount | $ 5,155,100 | ||
Shares Underlying Principal | Number | 1,517,996 | ||
2015 Convertible notes payable [Member] | Minimum [Member] | |||
Conversion price | $ / shares | $ 3.50 | ||
2015 Convertible notes payable [Member] | Maximum [Member] | |||
Conversion price | $ / shares | $ 7 | ||
2012 Convertible notes payable - related party [Member] | |||
Interest rate | 10.00% | 10.00% | |
Term of Notes | Due on demand | Due on demand | |
Conversion price | $ / shares | $ 3.30 | $ 3.30 | |
Principal Outstanding | $ 298,000 | $ 373,000 | |
Convertible notes payable related parties, Carrying Amount | $ 298,000 | $ 373,000 | |
Shares Underlying Principal | Number | 108,505 | 121,461 | |
2014 Convertible notes payable - related party [Member] | |||
Interest rate | 10.00% | 10.00% | |
Term of Notes | 2Â years | 2Â years | |
Conversion price | $ / shares | $ 7 | $ 7 | |
Principal Outstanding | $ 200,000 | ||
Convertible notes payable related parties, Carrying Amount | $ 200,000 | ||
Shares Underlying Principal | Number | 30,187 | ||
2015 Convertible notes payable - related party [Member] | |||
Interest rate | 10.00% | ||
Term of Notes | 2Â years | ||
Conversion price | $ / shares | $ 4.50 | ||
Principal Outstanding | $ 320,000 | ||
Convertible notes payable related parties, Carrying Amount | $ 320,000 | ||
Shares Underlying Principal | Number | 72,354 | ||
2013 Notes payable [Member] | |||
Interest rate | 10.00% | 10.00% | |
Term of Notes | Due on demand | Due on demand | |
Principal Outstanding | $ 830,000 | $ 1,030,000 | |
Notes payable, Carrying Amount | $ 830,000 | $ 1,030,000 | |
2014 Notes payable [Member] | |||
Interest rate | 11.00% | 11.00% | |
Term of Notes | Due on demand ~ 2Â years | Due on demand ~ 2Â years | |
Principal Outstanding | $ 1,446,950 | $ 1,446,950 | |
Notes payable, Carrying Amount | $ 1,446,950 | $ 1,446,950 | |
2015 Notes payable [Member] | |||
Interest rate | 11.00% | ||
Term of Notes | Due on demand ~ 2Â years | ||
Principal Outstanding | $ 2,379,799 | ||
Notes payable, Carrying Amount | $ 2,379,799 | ||
2012 Notes payable - related party [Member] | |||
Interest rate range, Minimum | 8.00% | 8.00% | |
Interest rate range, Maximum | 10.00% | 10.00% | |
Term of Notes | Due on demand | Due on demand | |
Principal Outstanding | $ 626,730 | $ 656,730 | |
Notes payable related parties, Carrying Amount | $ 626,730 | $ 656,730 | |
2013 Notes payable - related party [Member] | |||
Interest rate | 8.00% | 8.00% | |
Term of Notes | Due on demand | Due on demand | |
Principal Outstanding | $ 50,000 | $ 50,000 | |
Notes payable related parties, Carrying Amount | $ 50,000 | $ 50,000 | |
2014 Notes payable - related party [Member] | |||
Interest rate | 11.00% | 11.00% | |
Term of Notes | Due on demand ~ 2Â years | ||
Principal Outstanding | $ 240,308 | $ 252,165 | |
Notes payable related parties, Carrying Amount | $ 240,308 | 252,165 | |
2015 Notes payable - related party [Member] | |||
Interest rate range, Minimum | 10.00% | ||
Interest rate range, Maximum | 11.00% | ||
Term of Notes | Due on demand ~ 2Â years | ||
Principal Outstanding | $ 1,849,266 | ||
Notes payable related parties, Carrying Amount | $ 1,849,266 | ||
2014 Notes payable - related party [Member] | |||
Term of Notes | Due on demand ~ 2Â years | ||
Convertible notes payable [Member] | |||
Principal Outstanding | $ 11,086,986 | 7,977,072 | |
Discount Amount | 879,766 | 868,558 | |
Convertible notes payable, Carrying Amount | $ 10,207,220 | $ 7,108,514 | |
Shares Underlying Principal | Number | 2,988,484 | 2,263,965 | |
Principal Outstanding, Current | $ 6,358,698 | $ 3,478,904 | |
Principal Outstanding, Non Current | 4,728,288 | 4,498,168 | |
Discount Amount Current | 358,351 | 21,945 | |
Discount Amount Non Current | 521,415 | 846,613 | |
Convertible notes payable, Current | 6,000,347 | 3,456,959 | |
Convertible notes payable, Non Current | $ 4,206,873 | $ 3,651,555 | |
Shares Underlying Principal Current | Number | 1,762,849 | 1,156,050 | |
Shares Underlying Principal Non Current | Number | 1,225,635 | 1,107,915 | |
Convertible notes payable - related party [Member] | |||
Principal Outstanding | $ 618,000 | $ 573,000 | |
Convertible notes payable related parties, Carrying Amount | 618,000 | 573,000 | |
Total Carrying Amount | $ 298,000 | $ 373,000 | |
Shares Underlying Principal | Number | 180,859 | 121,461 | |
Principal Outstanding, Current | $ 298,000 | $ 373,000 | |
Principal Outstanding, Non Current | 320,000 | 200,000 | |
Convertible notes payable related parties, Current | 298,000 | 373,000 | |
Convertible notes payable related parties, Non Current | $ 320,000 | $ 200,000 | |
Shares Underlying Principal Current | Number | 108,505 | 121,461 | |
Shares Underlying Principal Non Current | Number | 72,354 | 30,187 | |
Notes Payable [Member] | |||
Principal Outstanding | $ 4,656,749 | $ 2,476,950 | |
Notes payable, Carrying Amount | 4,656,749 | 2,476,950 | |
Principal Outstanding, Current | 4,656,749 | 1,643,615 | |
Principal Outstanding, Non Current | 833,335 | ||
Notes payable, Current | 4,656,749 | 1,643,615 | |
Notes payable, Non Current | 833,335 | ||
Notes payable - related party [Member] | |||
Principal Outstanding | 2,766,304 | 958,895 | |
Notes payable related parties, Carrying Amount | 2,766,304 | 958,895 | |
Total Carrying Amount | 2,766,304 | 825,562 | |
Principal Outstanding, Current | 2,766,304 | 825,562 | |
Principal Outstanding, Non Current | 133,333 | ||
Notes payable related parties, Current | $ 2,766,304 | 825,562 | |
Notes payable related parties, Non Current | $ 133,333 |
NOTES PAYABLE (Details 1)
NOTES PAYABLE (Details 1) | Dec. 31, 2015USD ($) |
Contractual principal payments due on loans and notes payable for the year ending | |
2,016 | $ 14,079,751 |
2,017 | 5,048,288 |
Total | $ 19,128,039 |
NOTES PAYABLE (Details 2)
NOTES PAYABLE (Details 2) - $ / shares | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Fair value of options and warrants | ||
Stock Price | $ 4.50 | $ 4.90 |
Exercise Price | $ 4.90 | $ 3.50 |
Term | 5 years | 5 years |
Risk-free interest rate | 1.57% | 1.66% |
Expected volatility | 67.30% | 70.10% |
STOCKHOLDERS' DEFICIT (Details
STOCKHOLDERS' DEFICIT (Details Narrative) | Jun. 10, 2014USD ($)$ / Warrantsshares | Sep. 11, 2013USD ($)$ / sharesshares | Jun. 27, 2013shares | Dec. 31, 2015USD ($)$ / shares$ / Warrantsshares | Dec. 31, 2014USD ($)$ / sharesshares | Jun. 10, 2015USD ($) | Sep. 11, 2014USD ($) | Jul. 17, 2014$ / shares | Jul. 14, 2014shares | May. 08, 2014$ / shares | Feb. 26, 2014$ / shares | Dec. 31, 2013USD ($)$ / sharesshares | Sep. 09, 2013$ / shares | Feb. 28, 2013shares | Dec. 31, 2012$ / shares |
Share-based compensation | $ 3,708,801 | $ 6,521,812 | |||||||||||||
Share price (in dollars per share) | $ / shares | $ 4.50 | $ 4.90 | $ 5.10 | $ 4.90 | $ 3.60 | ||||||||||
Warrant derivative liabilities | $ 7,863,000 | $ 6,520,000 | |||||||||||||
Liability classified warrants | 3,206,000 | ||||||||||||||
Warrant exercise inducement expense | $ 3,523,000 | ||||||||||||||
Number of shares repurchased | shares | 500,000 | ||||||||||||||
Value of shares repurchased | $ 377,500 | ||||||||||||||
Number of shares cancelled | shares | 2,504,249 | 2,504,249 | |||||||||||||
Registrable Securities [Member] | |||||||||||||||
Numbers of units issued | shares | 4,115,966 | ||||||||||||||
Share price (in dollars per share) | $ / shares | $ 5.70 | ||||||||||||||
Number of cashless units warrants outstanding | $ 847,787 | $ 1,281,597 | |||||||||||||
Numbers of securities purchased | shares | 3,320,501 | ||||||||||||||
2011 Stock Incentive Option Plan [Member] | |||||||||||||||
Options outstanding | shares | 4,753,335 | 5,669,000 | 4,504,000 | ||||||||||||
Additional options granted | shares | 1,180,000 | ||||||||||||||
2011 Stock Incentive Option Plan [Member] | Stock Options [Member] | |||||||||||||||
Number of shares authorized under the plan | shares | 9,000,000 | 9,000,000 | 6,000,000 | ||||||||||||
Expiration period | 10 years | ||||||||||||||
Vesting period | 3 years | ||||||||||||||
Options outstanding | shares | 4,753,335 | ||||||||||||||
Weighted average grant-date fair value of options | $ / shares | $ 2.58 | ||||||||||||||
Weighted average grant-date fair value of common shares options | $ / shares | $ 4.06 | ||||||||||||||
Share-based compensation | $ 3,700,000 | $ 6,500,000 | |||||||||||||
Total unrecognized compensation cost | $ 700,000 | ||||||||||||||
Unrecognized compensation cost weighted average remaining period | 6 months | ||||||||||||||
2011 Stock Incentive Option Plan [Member] | Stock Options [Member] | Directors, Employees And Consultants [Member] | |||||||||||||||
Granted | shares | 840,000 | ||||||||||||||
Additional options granted | shares | 340,000 | ||||||||||||||
Fair value of options granted | $ 3,000,000 | ||||||||||||||
Private Placement [Member] | |||||||||||||||
Number of cashless units warrants outstanding | $ 2,225,036 | $ 2,225,036 | $ 2,225,036 | ||||||||||||
Warrant derivative liabilities | $ 1,800,000 | $ 1,095,465 | $ 7,068,000 | ||||||||||||
Numbers of securities purchased | shares | 1,095,465 | ||||||||||||||
Excrcise price (in dollars per share) | $ / Warrants | 3.50 | 3.50 | |||||||||||||
Number of replacement warrants | shares | 1,095,465 | ||||||||||||||
Method used | Binomial Monte-Carlo Cliquet (aka Ratchet) Option Pricing Model. | ||||||||||||||
Reclassified from liability classified | $ 2,545,000 | ||||||||||||||
Aggregate exercise proceeds of issuance | $ 3,800,000 | ||||||||||||||
Warrant exercise inducement expense | $ 3,500,000 | ||||||||||||||
Private Placement [Member] | Registrable Securities [Member] | |||||||||||||||
Share price (in dollars per share) | $ / shares | $ 4.70 | ||||||||||||||
Number of cashless units warrants outstanding | $ 3,320,501 | ||||||||||||||
Private Placement - Warrants [Member] | |||||||||||||||
Fair value of options granted | $ 3,000,000 | $ 7,863,000 | |||||||||||||
Numbers of units issued | shares | 3,020,501 | ||||||||||||||
Share price (in dollars per share) | $ / shares | $ 2.50 | ||||||||||||||
Description of private placement units | Each unit consisted of one share of common stock and one common stock warrant for the purchase of an additional share of common stock. | ||||||||||||||
Purchase price of units | $ 7,551,253 | ||||||||||||||
Common stock exercise price | $ / shares | $ 3.50 | ||||||||||||||
Numbers of securities purchased | shares | 300,000 | ||||||||||||||
Warrants [Member] | |||||||||||||||
Granted | shares | 110,417 | 1,145,465 | |||||||||||||
Share price (in dollars per share) | $ / shares | $ 4.70 | $ 4.70 | $ 4.90 | $ 3.60 | $ 3.60 | ||||||||||
Number of cashless units warrants outstanding | $ 75,838 | ||||||||||||||
Warrant derivative liabilities | $ 7,863,000 | $ 6,520,000 | |||||||||||||
Numbers of securities purchased | shares | 148,256 | ||||||||||||||
Liability classified warrants | $ 7,541,000 | $ 3,206,000 | $ 6,517,000 | ||||||||||||
Reclassified from liability classified | $ 7,863,000 | ||||||||||||||
Number of warrants shares cancelled | shares | 1,532,693 | 1,068,690 | |||||||||||||
Warrants [Member] | Maximum [Member] | |||||||||||||||
Excrcise price (in dollars per share) | $ / Warrants | 3.05 | ||||||||||||||
Warrants [Member] | Minimum [Member] | |||||||||||||||
Excrcise price (in dollars per share) | $ / Warrants | 1 | ||||||||||||||
Warrants [Member] | Director [Member] | |||||||||||||||
Numbers of units issued | shares | 500,000 | ||||||||||||||
Share price (in dollars per share) | $ / shares | $ 1 | ||||||||||||||
Warrants [Member] | Executive Officer [Member] | |||||||||||||||
Numbers of units issued | shares | 1,000,000 | ||||||||||||||
Share price (in dollars per share) | $ / shares | $ 2.50 | ||||||||||||||
Warrants [Member] | Convertible notes payable [Member] | |||||||||||||||
Numbers of units issued | shares | 110,417 | 50,000 | |||||||||||||
Share price (in dollars per share) | $ / shares | $ 3.50 | $ 4.90 | |||||||||||||
Warrant term | 5 years | 5 years |
STOCKHOLDERS' DEFICIT (Details)
STOCKHOLDERS' DEFICIT (Details) - Warrants [Member] - shares | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Warrants outstanding summary | ||
Warrants outstanding, beginning of period | 5,101,450 | 6,279,296 |
Granted | 110,417 | 1,145,465 |
Exercised | (148,256) | (1,254,621) |
Cancelled, forfeited and expired | (1,532,693) | (1,068,690) |
Warrants outstanding, end of period | 3,530,918 | 5,101,450 |
STOCKHOLDERS' DEFICIT (Detail53
STOCKHOLDERS' DEFICIT (Details 1) | 12 Months Ended |
Dec. 31, 2015shares | |
Warrants Issued in 2013 - Exercise Price $3.30 [Member] | |
Year Issued | 2,013 |
Weighted Average Exercise Price | 3.30 |
Outstanding | |
Number of Warrants Issued | 50,000 |
Weighted Average Remaining Contractual Life (Years) | 2 years 3 months 29 days |
Exercisable | |
Total | 50,000 |
Warrants Issued in 2013 - Exercise Price $3.50 [Member] | |
Year Issued | 2,013 |
Weighted Average Exercise Price | 3.50 |
Outstanding | |
Number of Warrants Issued | 2,225,036 |
Weighted Average Remaining Contractual Life (Years) | 2 years 8 months 12 days |
Exercisable | |
Total | 2,225,036 |
Warrants Issued in 2013 [Member] | |
Outstanding | |
Number of Warrants Issued | 2,275,036 |
Exercisable | |
Total | 2,275,036 |
Warrants Issued in 2014 - Exercise Price $3.50 [Member] | |
Year Issued | 2,014 |
Weighted Average Exercise Price | 3.50 |
Outstanding | |
Number of Warrants Issued | 1,145,465 |
Weighted Average Remaining Contractual Life (Years) | 2 years 8 months 23 days |
Exercisable | |
Total | 1,145,465 |
Warrants Issued in 2014 [Member] | |
Outstanding | |
Number of Warrants Issued | 1,145,465 |
Exercisable | |
Total | 1,145,465 |
Warrants Issued in 2015 - Exercise Price $4.90 [Member] | |
Year Issued | 2,015 |
Weighted Average Exercise Price | 4.90 |
Outstanding | |
Number of Warrants Issued | 110,417 |
Weighted Average Remaining Contractual Life (Years) | 4 years 2 months 9 days |
Exercisable | |
Total | 110,417 |
Warrants Issued in 2015 [Member] | |
Outstanding | |
Number of Warrants Issued | 3,530,918 |
Exercisable | |
Total | 3,530,918 |
STOCKHOLDERS' DEFICIT (Detail54
STOCKHOLDERS' DEFICIT (Details 2) - $ / shares | Jul. 17, 2014 | May. 08, 2014 | Feb. 26, 2014 | Dec. 31, 2015 | Dec. 31, 2014 |
Stockholders' Equity Note [Abstract] | |||||
Stock price | $ 5.10 | $ 4.90 | $ 3.60 | $ 4.50 | $ 4.90 |
Exercise price | $ 5.10 | $ 4.90 | $ 3.60 | ||
Term | 10 years | 10 years | 10 years | ||
Risk-Free Interest Rate | 2.47% | 2.61% | 2.67% | ||
Dividend Yield | 0.00% | 0.00% | 0.00% | ||
Volatility | 77.90% | 75.50% | 77.60% |
STOCKHOLDERS' DEFICIT (Detail55
STOCKHOLDERS' DEFICIT (Details 3) - $ / shares | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Prior 2011 Stock Incentive Plan [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | ||
Options outstanding, beginning of period | 11,795 | |
Cancelled, forfeited and expired | (11,795) | |
Options outstanding, end of period | 11,795 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price [Roll Forward] | ||
Options outstanding, beginning of period | $ 3.05 | |
Cancelled, forfeited and expired | $ 3.05 | |
Options outstanding, end of period | $ 3.05 | |
2011 Stock Incentive Option Plan [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | ||
Options outstanding, beginning of period | 5,669,000 | 4,504,000 |
Granted or deemed issued | 1,180,000 | |
Exercised | (2,000) | |
Cancelled, forfeited and expired | (913,665) | (15,000) |
Options outstanding, end of period | 4,753,335 | 5,669,000 |
Options exercisable at end of year | 4,379,335 | 2,855,251 |
Options available for future grant | 4,246,665 | 3,331,000 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price [Roll Forward] | ||
Options outstanding, beginning of period | $ 3.68 | $ 3.58 |
Granted or deemed issued | 4.06 | |
Exercised | 3.60 | |
Cancelled, forfeited and expired | 4.05 | 3.60 |
Options outstanding, end of period | 3.60 | 3.68 |
Options exercisable at end of year | $ 3.60 | $ 3.55 |
INCOME TAXES (Details Narrative
INCOME TAXES (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Statutory federal tax rate (in percent) | 34.00% | |
Operating loss carryforwards expiry year | 2,024 | |
Federal | ||
Net operating loss carryforwards | $ 42,909,000 | $ 36,673,000 |
State and Local | ||
Net operating loss carryforwards | $ 40,440,000 | $ 35,884,000 |
INCOME TAXES (Details)
INCOME TAXES (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Current | ||
U.S. | $ 2,400 | $ 2,500 |
International | 1,164 | 1,165 |
Deferred | ||
INCOME TAXES (BENEFIT) | $ 3,564 | $ 3,665 |
INCOME TAXES (Details 1)
INCOME TAXES (Details 1) - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 |
Income Tax Disclosure [Abstract] | ||
Net operating loss carryforward | $ 16,650,797 | $ 14,354,064 |
General business tax credit | 6,510,162 | 5,720,604 |
Stock options | 6,271,690 | 4,843,871 |
Charitable contribution | 79,944 | 81,434 |
Accrued expenses | 290,083 | 171,325 |
Other | 444,029 | 126,983 |
Total gross deferred tax assets | 30,247,605 | 25,298,281 |
Less valuation allowance | (30,116,742) | (25,184,004) |
Net deferred tax assets | $ 130,863 | $ 114,277 |
INCOME TAXES (Details 2)
INCOME TAXES (Details 2) - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 |
Income Tax Disclosure [Abstract] | ||
Unrealized gain on foreign exchange translation and others | $ (99,228) | $ (98,825) |
Unrealized gain on securities available-for-sale | (31,635) | (15,452) |
Total deferred tax liability | $ (130,863) | $ (114,277) |
INCOME TAXES (Details 3)
INCOME TAXES (Details 3) - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Income Tax Disclosure [Abstract] | ||
Tax benefit at statutory federal rate | $ (4,295,120) | $ (7,022,409) |
State taxes, net of federal tax benefit | (469,692) | (601,078) |
Increase in valuation allowance | 4,948,921 | 5,553,486 |
Permanent Items | 675,959 | 2,842,996 |
General business tax credit | (789,556) | (983,127) |
Other | (66,948) | 213,797 |
INCOME TAXES (BENEFIT) | $ 3,564 | $ 3,665 |
COMMITMENTS AND CONTINGENCIES61
COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Monthly commercialization management fee | $ 5,000 | |
Rent expense | $ 492,919 | $ 277,866 |
COMMITMENTS AND CONTINGENCIES62
COMMITMENTS AND CONTINGENCIES (Details) | Dec. 31, 2015USD ($) |
Future minimum lease payments | |
2,016 | $ 552,696 |
2,017 | 522,555 |
2,018 | 490,829 |
2,019 | 123,875 |
Total | $ 1,689,955 |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details Narrative) - USD ($) | Jun. 27, 2013 | Dec. 31, 2015 |
Number of shares cancelled | 2,504,249 | 2,504,249 |
License Agreement [Member] | ||
Royality percentage on net sales | 4.50% | |
Lifetime royalty to be paid | $ 100,000 | |
Decrease in royalty percentage on net sales | 2.50% | |
AFH Advisory [Member] | ||
Gain on derecognition of amounts due to related party | $ 394,446 | |
Targeted Medical Pharma Inc [Member] | ||
Number of shares issued | $ 150,000 |
RELATED PARTY TRANSACTIONS (D64
RELATED PARTY TRANSACTIONS (Details) | 12 Months Ended | ||||||
Dec. 31, 2015USD ($)$ / shares | Dec. 31, 2015USD ($)Number$ / shares | Dec. 31, 2014USD ($)Number$ / shares | |||||
Principal Amount Outstanding | $ 18,248,273 | $ 18,248,273 | $ 11,117,359 | ||||
Shares Underlying Principal | Number | 3,169,343 | 2,415,613 | |||||
Less discount | (879,766) | $ (879,766) | $ (868,558) | ||||
Total | $ 19,128,039 | $ 19,128,039 | |||||
Hope Hospice [Member] | |||||||
Annual Interest Rate | 8.00% | [1] | 8.00% | [1] | 8.00% | [2] | |
Date of Loan | Jan. 17, 2012 | [1] | Jan. 17, 2012 | [2] | |||
Term of Loan | Due on demand | [1] | Due on demand | [2] | |||
Principal Amount Outstanding | $ 200,000 | [1] | $ 200,000 | [1] | $ 200,000 | [2] | |
Highest Principal Outstanding | $ 200,000 | [1] | 200,000 | [1] | 200,000 | [2] | |
Amount of Interest Paid | $ 8,000 | [1] | $ 16,000 | [2] | |||
Hope Hospice [Member] | |||||||
Annual Interest Rate | 8.00% | [1] | 8.00% | [1] | 8.00% | [2] | |
Date of Loan | Jun. 14, 2012 | [1] | Jun. 14, 2012 | [2] | |||
Term of Loan | Due on demand | [1] | Due on demand | [2] | |||
Principal Amount Outstanding | $ 200,000 | [1] | $ 200,000 | [1] | $ 200,000 | [2] | |
Highest Principal Outstanding | $ 200,000 | [1] | 200,000 | [1] | 200,000 | [2] | |
Amount of Interest Paid | $ 8,000 | [1] | $ 20,000 | [2] | |||
Hope Hospice [Member] | |||||||
Annual Interest Rate | 8.00% | 8.00% | 8.00% | [2] | |||
Date of Loan | Jun. 21, 2012 | [1] | Jun. 21, 2012 | [2] | |||
Term of Loan | Due on demand | [1] | Due on demand | [2] | |||
Principal Amount Outstanding | $ 100,000 | $ 100,000 | $ 100,000 | [2] | |||
Highest Principal Outstanding | $ 100,000 | 100,000 | 100,000 | [2] | |||
Amount of Interest Paid | $ 4,000 | [1] | $ 10,000 | [2] | |||
Yutaka Niihara [Member] | |||||||
Annual Interest Rate | [3],[4] | 10.00% | 10.00% | 10.00% | |||
Date of Loan | [3],[4] | Dec. 5, 2012 | Dec. 5, 2012 | ||||
Term of Loan | [3],[4] | Due on demand | Due on demand | ||||
Principal Amount Outstanding | [3],[4] | $ 126,730 | $ 126,730 | $ 156,730 | |||
Highest Principal Outstanding | [3],[4] | $ 1,213,700 | 1,213,700 | 1,213,700 | |||
Amount of Principal Repaid | [3],[4] | 1,086,970 | 1,056,970 | ||||
Amount of Interest Paid | [3],[4] | $ 56,722 | $ 60,851 | ||||
Hope Hospice [Member] | |||||||
Annual Interest Rate | 8.00% | [1] | 8.00% | [1] | 8.00% | [2] | |
Date of Loan | Feb. 11, 2013 | [1] | Feb. 11, 2013 | [2] | |||
Term of Loan | Due on demand | [1] | Due on demand | [2] | |||
Principal Amount Outstanding | $ 50,000 | [1] | $ 50,000 | [1] | $ 50,000 | [2] | |
Highest Principal Outstanding | $ 50,000 | [1] | 50,000 | [1] | 50,000 | [2] | |
Amount of Interest Paid | $ 2,000 | [1] | $ 4,000 | [2] | |||
Lan T. Tran [Member] | |||||||
Annual Interest Rate | [4] | 11.00% | 11.00% | 11.00% | |||
Date of Loan | [4] | Feb. 10, 2014 | Feb. 10, 2014 | ||||
Term of Loan | [4],[5] | 2 years | 2 years | ||||
Principal Amount Outstanding | [4] | $ 106,976 | $ 106,976 | $ 106,976 | |||
Highest Principal Outstanding | [4] | $ 106,976 | $ 106,976 | $ 106,976 | |||
Cuc T. Tran [Member] | |||||||
Annual Interest Rate | [6] | 11.00% | 11.00% | 11.00% | |||
Date of Loan | [6] | Mar. 5, 2015 | Mar. 5, 2014 | ||||
Term of Loan | [6] | 1 years | 1 years | ||||
Principal Amount Outstanding | [6] | $ 13,161 | $ 13,161 | $ 11,856 | |||
Highest Principal Outstanding | [6] | 13,161 | 13,161 | 11,856 | |||
Notes payable - related party [Member] | |||||||
Principal Amount Outstanding | 2,766,304 | 2,766,304 | 825,562 | ||||
Highest Principal Outstanding | 3,873,275 | 3,873,275 | 1,882,532 | ||||
Amount of Principal Repaid | 1,106,970 | 1,056,970 | |||||
Amount of Interest Paid | 79,495 | $ 110,851 | |||||
Yasushi Nagasaki [Member] | |||||||
Annual Interest Rate | [4] | 10.00% | |||||
Date of Loan | [4] | Jun. 29, 2012 | |||||
Term of Loan | [4] | Due on demand | |||||
Principal Amount Outstanding | [4] | $ 373,000 | |||||
Highest Principal Outstanding | [4] | 388,800 | |||||
Amount of Principal Repaid | [4] | 15,800 | |||||
Amount of Interest Paid | [4] | $ 67,680 | |||||
Conversion price | $ / shares | [4] | $ 3.3 | |||||
Shares Underlying Principal | Number | [4] | 121,461 | |||||
Convertible notes payable - related party [Member] | |||||||
Principal Amount Outstanding | 298,000 | 298,000 | $ 373,000 | ||||
Highest Principal Outstanding | $ 388,800 | 388,800 | 388,800 | ||||
Amount of Principal Repaid | $ 90,800 | 15,800 | |||||
Amount of Interest Paid | $ 67,680 | ||||||
Shares Underlying Principal | Number | 180,859 | 121,461 | |||||
Hideki and Eiko Uehara [Member] | |||||||
Annual Interest Rate | [6] | 11.00% | 11.00% | 11.00% | |||
Date of Loan | [6] | Feb. 15, 2014 | Feb. 15, 2014 | ||||
Term of Loan | [6] | 2 years | 2 years | ||||
Principal Amount Outstanding | [6] | $ 133,333 | $ 133,333 | $ 133,333 | |||
Highest Principal Outstanding | [6] | 133,333 | 133,333 | 133,333 | |||
Amount of Interest Paid | [6] | 14,697 | |||||
Long-term promissory note payable to related parties [Member] | |||||||
Principal Amount Outstanding | 133,333 | ||||||
Highest Principal Outstanding | 133,333 | ||||||
Amount of Interest Paid | $ 14,697 | ||||||
Phillip M. Satow [Member] | |||||||
Annual Interest Rate | [3] | 10.00% | |||||
Date of Loan | [3] | Jun. 6, 2014 | |||||
Term of Loan | [3] | 2 years | |||||
Principal Amount Outstanding | [3] | $ 100,000 | |||||
Highest Principal Outstanding | [3] | $ 100,000 | |||||
Conversion price | $ / shares | [3] | $ 7 | |||||
Shares Underlying Principal | Number | [3] | 15,103 | |||||
Richard S. Pechter [Member] | |||||||
Annual Interest Rate | [6] | 10.00% | |||||
Date of Loan | [6] | Jun. 11, 2014 | |||||
Term of Loan | [6] | 2 years | |||||
Principal Amount Outstanding | [6] | $ 100,000 | |||||
Highest Principal Outstanding | [6] | $ 100,000 | |||||
Conversion price | $ / shares | [6] | $ 7 | |||||
Shares Underlying Principal | Number | [6] | 15,084 | |||||
Long-term convertible notes payable - related party [Member] | |||||||
Principal Amount Outstanding | 320,000 | 320,000 | $ 200,000 | ||||
Highest Principal Outstanding | 320,000 | $ 320,000 | $ 200,000 | ||||
Shares Underlying Principal | Number | 72,354 | 30,187 | |||||
Notes payable and convertible notes payable - related party [Member] | |||||||
Principal Amount Outstanding | 3,384,304 | $ 3,384,304 | $ 1,531,895 | ||||
Highest Principal Outstanding | $ 4,582,075 | 4,582,075 | 2,604,665 | ||||
Amount of Principal Repaid | $ 1,197,770 | 1,072,770 | |||||
Amount of Interest Paid | $ 193,228 | ||||||
Shares Underlying Principal | Number | 180,859 | 151,648 | |||||
Hope Hospice [Member] | |||||||
Annual Interest Rate | [1] | 10.00% | 10.00% | ||||
Date of Loan | [1] | Jan. 7, 2015 | |||||
Term of Loan | [1],[5] | 2 years | |||||
Principal Amount Outstanding | [1] | $ 100,000 | $ 100,000 | ||||
Highest Principal Outstanding | [1] | $ 100,000 | $ 100,000 | ||||
James Lee [Member] | |||||||
Annual Interest Rate | [6] | 10.00% | 10.00% | ||||
Date of Loan | [6] | Jan. 26, 2015 | |||||
Term of Loan | [5],[6] | 2 years | |||||
Principal Amount Outstanding | [6] | $ 50,000 | $ 50,000 | ||||
Highest Principal Outstanding | [6] | $ 50,000 | $ 50,000 | ||||
Hope Hospice [Member] | |||||||
Annual Interest Rate | [1] | 10.00% | 10.00% | ||||
Date of Loan | [1] | Jan. 29, 2015 | |||||
Term of Loan | [1],[5] | 2 years | |||||
Principal Amount Outstanding | [1] | $ 30,000 | $ 30,000 | ||||
Highest Principal Outstanding | [1] | $ 30,000 | $ 30,000 | ||||
Yutaka Niihara [Member] | |||||||
Annual Interest Rate | [3],[4] | 10.00% | 10.00% | ||||
Date of Loan | [3],[4] | Jan. 29, 2015 | |||||
Term of Loan | [3],[4] | 2 years | |||||
Principal Amount Outstanding | [3],[4] | ||||||
Highest Principal Outstanding | [3],[4] | $ 20,000 | $ 20,000 | ||||
Amount of Principal Repaid | [3],[4] | 20,000 | |||||
Amount of Interest Paid | [3],[4] | $ 773 | |||||
Lan T. Tran [Member] | |||||||
Annual Interest Rate | [4] | 10.00% | 10.00% | ||||
Date of Loan | [4] | Feb. 9, 2015 | |||||
Term of Loan | [4],[5] | 2 years | |||||
Principal Amount Outstanding | [4] | $ 10,000 | $ 10,000 | ||||
Highest Principal Outstanding | [4] | $ 10,000 | $ 10,000 | ||||
Charles Stark [Member] | |||||||
Annual Interest Rate | [4] | 10.00% | 10.00% | ||||
Date of Loan | [4] | Feb. 10, 2015 | |||||
Term of Loan | [4],[5] | 2 years | |||||
Principal Amount Outstanding | [4] | $ 10,000 | $ 10,000 | ||||
Highest Principal Outstanding | [4] | $ 10,000 | $ 10,000 | ||||
IRA Service Trust Co. FBO Peter B. Ludlum [Member] | |||||||
Annual Interest Rate | [4] | 10.00% | 10.00% | ||||
Date of Loan | [4] | Feb. 20, 2015 | |||||
Term of Loan | [4],[5] | 2 years | |||||
Principal Amount Outstanding | [4] | $ 10,000 | $ 10,000 | ||||
Highest Principal Outstanding | [4] | $ 10,000 | $ 10,000 | ||||
Yutaka Niihara [Member] | |||||||
Annual Interest Rate | [3],[4] | 10.00% | 10.00% | ||||
Date of Loan | [3],[4] | Apr. 7, 2015 | |||||
Term of Loan | [3],[4] | 2 years | |||||
Principal Amount Outstanding | [3],[4] | $ 500,000 | $ 500,000 | ||||
Highest Principal Outstanding | [3],[4] | $ 500,000 | $ 500,000 | ||||
Yutaka Niihara [Member] | |||||||
Annual Interest Rate | [3],[4] | 10.00% | 10.00% | ||||
Date of Loan | [3],[4] | May 21, 2015 | |||||
Term of Loan | [3],[4] | Due on demand | |||||
Principal Amount Outstanding | [3],[4] | $ 826,105 | $ 826,105 | ||||
Highest Principal Outstanding | [3],[4] | $ 826,105 | $ 826,105 | ||||
Masaharu & Emiko Osato [Member] | |||||||
Annual Interest Rate | [3] | 11.00% | 11.00% | ||||
Date of Loan | [3] | Dec. 29, 2015 | |||||
Term of Loan | Due on demand | ||||||
Principal Amount Outstanding | [3] | $ 300,000 | $ 300,000 | ||||
Highest Principal Outstanding | [3] | $ 300,000 | $ 300,000 | ||||
Yasushi Nagasaki [Member] | |||||||
Annual Interest Rate | [4] | 10.00% | 10.00% | ||||
Date of Loan | [4] | Jun. 29, 2012 | |||||
Term of Loan | [4] | Due on demand | |||||
Principal Amount Outstanding | [4] | $ 298,000 | $ 298,000 | ||||
Highest Principal Outstanding | [4] | $ 388,800 | 388,800 | ||||
Amount of Principal Repaid | [4] | $ 90,800 | |||||
Conversion price | $ / shares | [4] | $ 3.3 | $ 3.3 | ||||
Shares Underlying Principal | Number | [4] | 103,953 | |||||
Yutaka Niihara [Member] | |||||||
Annual Interest Rate | [3],[4] | 10.00% | 10.00% | ||||
Date of Loan | [3],[4] | Sep. 29, 2015 | |||||
Term of Loan | [3],[4] | 2 years | |||||
Principal Amount Outstanding | [3],[4] | $ 100,000 | $ 100,000 | ||||
Highest Principal Outstanding | [3],[4] | $ 100,000 | $ 100,000 | ||||
Conversion price | $ / shares | [3],[4] | $ 4.50 | $ 4.50 | ||||
Shares Underlying Principal | Number | [3],[4] | 22,794 | |||||
Charles & Kimxa Stark [Member] | |||||||
Annual Interest Rate | [4] | 10.00% | 10.00% | ||||
Date of Loan | [4] | Oct. 1, 2015 | |||||
Term of Loan | [4] | 2 years | |||||
Principal Amount Outstanding | [4] | $ 20,000 | $ 20,000 | ||||
Highest Principal Outstanding | [4] | $ 20,000 | $ 20,000 | ||||
Conversion price | $ / shares | [4] | $ 4.50 | $ 4.50 | ||||
Shares Underlying Principal | Number | [4] | 4,556 | |||||
Yutaka & Soomi Niihara [Member] | |||||||
Annual Interest Rate | [3],[4] | 10.00% | 10.00% | ||||
Date of Loan | [3],[4] | Nov. 16, 2015 | |||||
Term of Loan | [3],[4] | 2 years | |||||
Principal Amount Outstanding | [3],[4] | $ 200,000 | $ 200,000 | ||||
Highest Principal Outstanding | [3],[4] | $ 200,000 | $ 200,000 | ||||
Conversion price | $ / shares | [3],[4] | $ 4.50 | $ 4.50 | ||||
Shares Underlying Principal | Number | [3],[4] | 45,004 | |||||
[1] | Dr. Niihara, who is the Company's CEO, is also the CEO of Hope International Hospice, Inc ("Hope Hospice"). | ||||||
[2] | Dr. Niihara, who is the Company's CEO, is also the CEO of Hope Hospice. | ||||||
[3] | Director | ||||||
[4] | Officer | ||||||
[5] | Due on Demand | ||||||
[6] | Family of Officer/Director |
GEOGRAPHIC INFORMATION (Details
GEOGRAPHIC INFORMATION (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Japan [Member] | ||
Company revenue earned from countries outside of the U.S. | ||
Sales | $ 194,142 | $ 179,570 |
Percentage of revenue (in percent) | 33.00% | 36.00% |
Taiwan [Member] | ||
Company revenue earned from countries outside of the U.S. | ||
Sales | $ 277,637 | $ 193,552 |
Percentage of revenue (in percent) | 47.00% | 39.00% |
South Korea [Member] | ||
Company revenue earned from countries outside of the U.S. | ||
Sales | $ 39,660 | $ 45,312 |
Percentage of revenue (in percent) | 7.00% | 9.00% |
SUBSEQUENT EVENTS (Details)
SUBSEQUENT EVENTS (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | ||
Principal Amounts | $ 19,128,039 | $ 11,985,917 | |
Minimum [Member] | |||
Conversion price | $ 3.05 | ||
Maximum [Member] | |||
Conversion price | $ 3.60 | ||
Subsequent Event [Member] | |||
Principal Amounts | $ 2,865,997 | ||
Subsequent Event [Member] | Convertible Notes [Member] | |||
Principal Amounts | [1] | $ 749,009 | |
Annual Interest Rate | [1] | 10.00% | |
Term of Notes | [1] | Due on Demand up to 2 Years | |
Conversion price | [1] | $ 3.60 | |
Subsequent Event [Member] | Convertible Notes [Member] | |||
Principal Amounts | [2] | $ 490,110 | |
Annual Interest Rate | [2] | 10.00% | |
Term of Notes | [2] | 2 years | |
Conversion price | [2] | $ 4.50 | |
Subsequent Event [Member] | Promissory Note [Member] | |||
Principal Amounts | $ 250,000 | ||
Annual Interest Rate | 11.00% | ||
Term of Notes | 6 months | ||
Subsequent Event [Member] | Promissory Note [Member] | |||
Principal Amounts | [1] | $ 833,335 | |
Annual Interest Rate | [1] | 11.00% | |
Term of Notes | [1] | Due on Demand | |
Subsequent Event [Member] | Promissory Notes - Related Party [Member] | |||
Principal Amounts | [1] | $ 263,843 | |
Annual Interest Rate | [1] | 11.00% | |
Term of Notes | [1] | Due on Demand | |
Subsequent Event [Member] | Promissory Notes - Related Party [Member] | |||
Principal Amounts | $ 529,700 | ||
Term of Notes | Due on Demand up to 2 Years | ||
Subsequent Event [Member] | Promissory Notes - Related Party [Member] | Minimum [Member] | |||
Annual Interest Rate | 10.00% | ||
Subsequent Event [Member] | Promissory Notes - Related Party [Member] | Maximum [Member] | |||
Annual Interest Rate | 11.00% | ||
[1] | Refinancings of prior notes alreay outstanding. | ||
[2] | Includes mandatory conversion at the time of an intial public offering at a conversion price equal to 80% of the intial public offering price. |
SUBSEQUENT EVENTS (Details 1)
SUBSEQUENT EVENTS (Details 1) - Subsequent Event [Member] | 12 Months Ended |
Dec. 31, 2015USD ($)shares | |
Principal Amount | $ | $ 1,799,999 |
Number of Shares Issued | shares | 400,000 |
Common Stock [Member] | |
Principal Amount | $ | $ 1,700,000 |
Number of Shares Issued | shares | 377,778 |
Common Stock - Related Party [Member] | |
Principal Amount | $ | $ 99,999 |
Number of Shares Issued | shares | 22,222 |
SUBSEQUENT EVENTS (Details 2)
SUBSEQUENT EVENTS (Details 2) - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Principal Outstanding | $ 19,128,039 | $ 11,985,917 |
Subsequent Event [Member] | ||
Principal Outstanding | 2,865,997 | |
Subsequent Event [Member] | Secured Loans [Member] | ||
Principal Outstanding | $ 1,295,000 | |
Annual Interest Rate (in percent) | 10.00% | |
Term of notes, textual description | Earlier of closing of new debt financing or May 1, 2017 |