CorMedix (CRMD) 10-Q 12 Nov 15 2015 Q3 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	9 Months Ended
	Sep. 30, 2015	Nov. 06, 2015
Document And Entity Information
Entity Registrant Name	CorMedix Inc.
Entity Central Index Key	1,410,098
Document Type	10-Q
Document Period End Date	Sep. 30, 2015
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Is Entity a Well-known Seasoned Issuer?	No
Is Entity a Voluntary Filer?	No
Is Entity's Reporting Status Current?	Yes
Entity Filer Category	Smaller Reporting Company
Entity Common Stock, Shares Outstanding		35,376,502
Document Fiscal Period Focus	Q3
Document Fiscal Year Focus	2,015

CONDENSED CONSOLIDATED BALANCE

CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($)	Sep. 30, 2015	Dec. 31, 2014
Current assets
Cash and cash equivalents	$ 14,246,979	$ 4,339,540
Restricted cash	171,553	0
Short-term investments	23,604,615	0
Trade receivables	124,745	80,183
Inventories, net	699,148	463,029
Prepaid expense, clinical	86,191	0
Prepaid expenses and other current assets	327,276	155,210
Total current assets	39,260,507	5,037,962
Property and equipment, net	41,075	41,458
Security deposit	5,000	18,342
TOTAL ASSETS	39,306,582	5,097,762
Current liabilities
Accounts payable	1,424,668	893,385
Accrued expenses	1,450,157	521,525
Deferred revenue	6,769	10,477
Total current liabilities	2,881,594	1,425,387
Deferred revenue, long term	33,391	37,903
TOTAL LIABILITIES	$ 2,914,985	$ 1,463,290
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS' EQUITY
Preferred stock - $0.001 par value: 2,000,000 shares authorized; 450,085 and 949,948 shares issued and outstanding at September 30, 2015 and December 31, 2014, respectively	$ 450	$ 950
Common stock - $0.001 par value: 80,000,000 shares authorized; 35,376,502 and 22,461,668 shares issued and outstanding at September 30, 2015 and December 31, 2014, respectively	35,377	22,461
Deferred stock issuances	(110)	(110)
Accumulated other comprehensive income	99,786	98,972
Additional paid-in capital	126,781,405	79,716,265
Accumulated deficit	(90,525,311)	(76,204,066)
TOTAL STOCKHOLDERS' EQUITY	36,391,597	3,634,472
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$ 39,306,582	$ 5,097,762

CONDENSED CONSOLIDATED BALANCE3

CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares	Sep. 30, 2015	Dec. 31, 2014
Statement of Financial Position [Abstract]
Preferred stock, par value	$ 0.001	$ 0.001
Preferred stock, shares authorized	2,000,000	2,000,000
Preferred stock, shares issued	450,085	949,948
Preferred stock, shares outstanding	450,085	949,948
Common stock, par value	$ 0.001	$ 0.001
Common stock, shares authorized	80,000,000	80,000,000
Common stock, shares issued	35,376,502	22,461,668
Common stock, shares outstanding	35,376,502	22,461,668

CONDENSED CONSOLIDATED STATEMEN

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE GAIN (LOSS) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2015	Sep. 30, 2014	Sep. 30, 2015	Sep. 30, 2014
Revenue
Net sales	$ 35,947	$ 52,441	$ 187,184	$ 104,373
Cost of sales	(35,396)	(36,675)	(154,514)	(172,180)
Gross profit (loss)	551	15,766	32,670	(67,807)
Operating Expenses
Research and development	(1,764,468)	(292,688)	(4,796,571)	(817,635)
Selling, general and administrative	(2,948,643)	(1,586,614)	(9,580,174)	(5,802,364)
Total Operating Expenses	(4,713,111)	(1,879,302)	(14,376,745)	(6,619,999)
Loss From Operations	(4,712,560)	(1,863,536)	(14,344,075)	(6,687,806)
Other Income (Expense)
Interest income	25,019	645	30,817	2,153
Foreign exchange transaction gain (loss)	674	(122,645)	(5,352)	(150,803)
Loss on issuance of preferred stock, convertible notes and warrants	0	0	0	(89,590)
Change in fair value of derivative liabilities	0	(586,440)	0	(8,848,953)
Loss on modification of equity instruments and extinguishment of derivative liabilities	0	(2,462,588)	0	(2,462,588)
Interest expense	(1,609)	(553)	(2,635)	(1,531)
Total Income (Expense)	24,084	(3,171,581)	22,830	(11,551,312)
Net Loss	(4,688,476)	(5,035,117)	(14,321,245)	(18,239,118)
Other Comprehensive Income (Loss)
Unrealized loss from investments	5,852	0	348	0
Foreign currency translation gain	1,230	118,319	466	126,302
Total Other Comprehensive Income	7,082	118,319	814	126,302
Comprehensive Loss	(4,681,394)	(4,916,798)	(14,320,431)	(18,112,816)
Net loss	(4,688,476)	(5,035,117)	(14,321,245)	(18,239,118)
Dividends, including beneficial conversion feature	0	(27,125)	(33,121)	(81,727)
Net Loss Attributable To Common Shareholders	$ (4,688,476)	$ (5,062,242)	$ (14,354,366)	$ (18,320,845)
Net Loss Per Common Share - Basic and Diluted	$ (0.14)	$ (0.23)	$ (0.48)	$ (0.87)
Weighted Average Common Shares Outstanding - Basic and Diluted	34,585,543	22,080,673	30,082,478	21,161,532

CONDENSED CONSOLIDATED STATEME5

CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS' EQUITY - 9 months ended Sep. 30, 2015 - USD ($)	Common Stock	Non-Voting Preferred Stock - Series B, Series C-2, Series C-3, Series D and Series E	Deferred Stock Issuances	Accumulated Other Comprehensive Income	Additional Paid-In Capital	Accumulated Deficit	Total
Beginning balance (in shares) at Dec. 31, 2014	22,461,668	949,948
Beginning balance at Dec. 31, 2014	$ 22,461	$ 950	$ (110)	$ 98,972	$ 79,716,265	$ (76,204,066)	$ 3,634,472
Conversion of Series B non-voting preferred stock to common stock, Shares	454,546	(454,546)
Conversion of Series B non-voting preferred stock to common stock, Amount	$ 455	$ (455)			0		0
Conversion of Series C-3 non-voting preferred stock to common stock, shares	425,000	(42,500)
Conversion of Series C-3 non-voting preferred stock to common stock, amount	$ 425	$ (42)			(383)		0
Conversion of Series E non-voting preferred stock to common stock, Shares	61,598	(2,817)
Conversion of Series E non-voting preferred stock to common stock, Amount	$ 62	$ (3)			(59)		0
Stock issued in connection with warrants exercised, Shares	4,581,783
Stock issued in connection with warrants exercised, Amount	$ 4,582				14,653,579		14,658,161
Stock issued in connection with warrants cashless exercised, Shares	2,158,033
Stock issued in connection with warrants cashless exercised, Amount	$ 2,158				(2,158)		0
Stock issued in connection with stock options exercised, Shares	499,955
Stock issued in connection with stock options exercised, Amount	$ 500				492,460		492,960
Stock issued in connection with sale of common stock, Shares	4,723,191
Stock issued in connection with sale of common stock, Amount	$ 4,723				27,238,029		27,242,752
Stock issued in connection with conversion of wages, Shares	10,728
Stock issued in connection with conversion of wages, Amount	$ 11				49,989		50,000
Value of warrants issued in connection with backstop financing					1,583,252		1,583,252
Modification of warrant agreement					112,982		112,982
Short swing profit recovery					28,594		28,594
Stock-based compensation					2,908,855		2,908,855
Other comprehensive income				814			814
Net loss						(14,321,245)	(14,321,245)
Ending balance (in shares) at Sep. 30, 2015	35,376,502	450,085
Ending balance at Sep. 30, 2015	$ 35,377	$ 450	$ (110)	$ 99,786	$ 126,781,405	$ (90,525,311)	$ 36,391,597

CONDENSED CONSOLIDATED STATEME6

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($)	9 Months Ended
	Sep. 30, 2015	Sep. 30, 2014
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$ (14,321,245)	$ (18,239,118)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation	2,908,855	1,942,192
Value of warrants issued in connection with backstop financing	1,583,252	0
Modification of warrant agreement	112,982	0
Loss on foreign currency transactions	0	150,803
Loss on issuance of warrants and preferred stock	0	89,590
Loss on modification of equity instruments and extinguishment of derivative liabilities	0	2,462,588
Revaluation of derivative liability	0	8,848,953
Depreciation	11,087	11,467
Changes in operating assets and liabilities:
Restricted cash	(171,553)	220,586
Trade receivables	(50,178)	(47,353)
Inventory	(236,120)	(597,396)
Prepaid expense, clinical	(86,191)	0
Prepaid expenses and other current assets	(161,240)	95,611
Accounts payable	538,533	(170,898)
Accrued expenses	988,198	441,469
Deferred revenue and rent	(8,221)	44,830
Net cash used in operating activities	(8,891,841)	(4,746,676)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of short-term investments	(23,604,267)	0
Purchase of equipment	(13,796)	(25,898)
Net cash used in investing activities	(23,618,063)	(25,898)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from Series C-3 preferred stock, net	0	743,884
Proceeds from Series C-3 preferred stock, related party	0	575,000
Proceeds from sale of common stock from an at-the-market program	27,242,752	0
Proceeds from exercise of warrants	14,658,161	0
Proceeds from exercise of stock options	492,960	309,450
Proceeds from short swing profit recovery	28,594	0
Payments for deferred financing costs	0	(2,366)
Proceeds from sale of equity securities	0	6,723,248
Net cash provided by financing activities	42,422,467	8,349,216
Foreign exchange effect on cash	(5,124)	(30,515)
NET INCREASE IN CASH	9,907,439	3,546,127
CASH - BEGINNING OF PERIOD	4,339,540	2,373,893
CASH - END OF PERIOD	14,246,979	5,920,020
Cash paid for interest	2,635	1,531
Supplemental Disclosure of Non-Cash Financing Activities:
Conversion of preferred stock to common stock	500	2,447,384
Conversion of accounts payable and accrued expenses to preferred stock	0	645,458
Reclassification of derivative liability to equity	0	17,955,143
Conversion of wages and fees to common stock	50,000	42,500
Dividend, including beneficial conversion feature	$ 33,121	$ 81,727

1. Organization, Business and B

1. Organization, Business and Basis of Presentation	9 Months Ended
	Sep. 30, 2015
Organization Business And Basis Of Presentation
Organization, Business and Basis of Presentation	Organization and Business CorMedix Inc. (“CorMedix” or the “Company”) was incorporated in the State of Delaware on July 28, 2006. The Company seeks to in-license, develop and commercialize prophylactic and therapeutic products for the prevention and treatment of infectious diseases in cardiac, renal and oncology patients. In 2013, the Company formed a wholly owned subsidiary, CorMedix Europe GmbH. The Company’s primary activities since incorporation have been organizational activities, including recruiting personnel, establishing office facilities, acquiring licenses for its pharmaceutical product candidates, performing business and financial planning, performing research and development, seeking regulatory approval for its products and conducting initial commercialization activities for its product Neutrolin ® The Company received CE Mark approval for Neutrolin in 2013 and began the commercial launch of Neutrolin in Germany for the prevention of catheter-related bloodstream infections and maintenance of catheter patency in hemodialysis patients using a tunneled, cuffed central venous catheter for vascular access. To date, Neutrolin is registered and may be sold in Austria, Germany, Italy, Malta, Saudi Arabia, Bahrain, Qatar, Kuwait, United Arab Emirates and The Netherlands. In September 2014, the TUV-SUD and The Medicines Evaluation Board of the Netherlands granted a label expansion for Neutrolin for expanded indications for the European Union (“EU”). In December 2014, the Company received approval from the Hessian District President in Germany to expand the label to include use in oncology patients receiving chemotherapy, intravenous (“IV”), hydration and IV medications via central venous catheters. The expansion also adds patients receiving medication and IV fluids via central venous catheters in intensive or critical care units (cardiac care unit, surgical care unit, neonatal critical care unit, and urgent care centers). An indication for use in total parenteral nutrition was also approved. The Company plans to initiate a Phase 3 clinical trial in hemodialysis catheters in the U.S. in the fourth quarter of 2015 and a Phase 3 clinical trial in oncology/total parenteral nutrition in mid-2016. In January 2015, the U.S. Food and Drug Administration (“FDA”) granted Fast Track designation to Neutrolin® Catheter Lock Solution for the prevention of catheter-related blood stream infections. Fast Track designation is granted to drug products designed to treat a serious condition and address an unmet medical need. The Fast Track designation of Neutrolin provides the Company with the opportunity to meet with the FDA on a more frequent basis during the drug development process, and also ensures eligibility for priority review and rolling review of the marketing application. The FDA designated Neutrolin as a Qualified Infectious Disease Product (QIDP) in January 2015 for catheter-related blood stream infections in hemodialysis patients, which can be life-threatening. The QIDP designation will make Neutrolin eligible to benefit from certain incentives, such as priority review, and it also allows for an additional five years of marketing exclusivity when approval is granted by FDA. Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and with the instructions for Form 10-Q and Article 10 of Regulation S-X. Accordingly, these unaudited condensed consolidated financial statements do not include all information and footnotes required by GAAP for complete annual financial statements. In the opinion of management, the accompanying unaudited condensed consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation of such interim results. Interim operating results are not necessarily indicative of results that may be expected for the full year ending December 31, 2015 or for any subsequent period. These unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto of the Company for the year ended December 31, 2014, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2014 (the “2014 Form 10-K”) filed with the Securities and Exchange Commission (the “SEC”) on March 12, 2015. The accompanying condensed balance sheet as of December 31, 2014 has been derived from the audited financial statements included in the 2014 Form 10-K.

2. Summary of Significant Accou

2. Summary of Significant Accounting Policies	9 Months Ended
	Sep. 30, 2015
Accounting Policies [Abstract]
Summary of Significant Accounting Policies	Liquidity, Risks and Uncertainties The Company’s operations are subject to a number of factors that can affect its operating results and financial condition. Such factors include, but are not limited to: the results of clinical testing and trial activities of the Company’s product candidates; the ability to obtain regulatory approval to market the Company’s products; competition from products manufactured and sold or being developed by other companies, the price of, and demand for, Company products; the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products; and the Company’s ability to raise capital. To date, the Company’s commercial operations have not generated enough revenues to make the Company profitable. Based on the current development plans for Neutrolin in both the United States (“U.S.”) and foreign markets (including the planned hemodialysis Phase 3 clinical trial in the U.S.) and on the current revenue assumptions for Neutrolin in approved markets, management believes that the existing cash will be sufficient to fund its operations for at least the next 12 months following this balance sheet date. Nevertheless, the Company’s continued operations, including the completion of its planned Phase 3 clinical trial for Neutrolin in hemodialysis patients in the U.S., will depend on its ability to raise additional capital through potential sources such as equity and/or debt financings, strategic relationships, and/or out-licensing or distribution arrangements of its products. The Company also plans to conduct an oncology/total parenteral nutrition patient Phase 3 clinical trial in the U.S. for which additional funds over and above the funds needed for the hemodialysis Phase 3 clinical trial will be required to complete that study. However, the Company can provide no assurances that such financing or strategic relationships will be available on acceptable terms, or at all. If the Company is unable to raise sufficient capital or find strategic partners, there would be a material adverse effect on its business. Further, the Company expects to incur increases in its cash use from operations as it continues to commercialize Neutrolin internationally, increase its business development activities, incur legal costs to defend its intellectual property and seek FDA approval of Neutrolin in the U.S. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates. Basis of Consolidation The condensed consolidated financial statements include the accounts of the Company and CorMedix Europe GmbH, a wholly owned subsidiary. All significant intercompany accounts and transactions have been eliminated in consolidation. Cash and Cash Equivalents The Company considers all highly liquid instruments with an original maturity of 90 days or less at the time of purchase to be cash equivalents. Cash and cash equivalents consist of deposits and other interest bearing accounts, the balances of which, at times, may exceed federally insured limits. Short-Term Investments The Company determines the appropriate classification of marketable securities at the time of purchase and reevaluates such designation as of each balance sheet date. Investments in marketable debt and equity securities classified as available-for-sale are reported at fair value. Fair values of the Company’s investments are determined using quoted market prices in active markets for identical assets or liabilities or quoted prices for similar assets or liabilities or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Changes in fair value that are considered temporary are reported net of tax in other comprehensive income (loss). Realized gains and losses, amortization of premiums and discounts and interest and dividends earned are included in income (expense) on the condensed consolidated statements of operations and comprehensive income (loss). The cost of investments for purposes of computing realized and unrealized gains and losses is based on the specific identification method. For declines in the fair value of equity securities that are considered other-than-temporary, impairment losses are charged to other (income) expense, net. The Company considers available evidence in evaluating potential impairments of its investments, including the duration and extent to which fair value is less than cost. There were no deemed permanent impairments at September 30, 2015. The Company’s marketable securities are highly liquid and consist of U.S. government agency securities, high-grade corporate obligations and commercial paper with original maturities of more than 90 days. As of September 30, 2015, all of the Company’s investments had contractual maturities which were less than one year. The following table summarizes the amortized cost, unrealized gains and losses and the fair value at September 30, 2015 of the Company’s financial assets that are measured on a recurring basis: Amortized Cost Gross Unrealized Losses Gross Unrealized Gains Fair Value Money Market Funds included in Cash Equivalents $ 3,334,894 $ — $ — $ 3,334,894 US Government Agency Securities 6,550,635 (298 ) 773 6,551,110 Corporate Securities 15,054,267 (2,076 ) 1,949 15,054,140 Commercial Paper 1,999,365 — — 1,999,365 Subtotal 23,604,267 (2,374 ) 2,722 23,604,615 $ 26,939,161 $ (2,374 ) $ 2,722 $ 26,939,509 Fair Value Measurements The Company’s financial instruments recorded in the consolidated balance sheets include cash and cash equivalents, accounts receivable, investment securities, accounts payable and accrued expenses. The carrying value of certain financial instruments, primarily cash and cash equivalents, accounts receivable, accounts payable, and accrued expenses approximate their estimated fair values based upon the short-term nature of their maturity dates. The Company categorizes its financial instruments into a three-level fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets (Level 1) and the lowest priority to unobservable inputs (Level 3). If the inputs used to measure fair value fall within different levels of the hierarchy, the category level is based on the lowest priority level input that is significant to the fair value measurement of the instrument. Financial assets recorded at fair value on the Company’s condensed consolidated balance sheets are categorized as follows: • Level 1 inputs—Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets. • Level 2 inputs— Significant other observable inputs (e.g., quoted prices for similar items in active markets, quoted prices for identical or similar items in markets that are not active, inputs other than quoted prices that are observable such as interest rate and yield curves, and market-corroborated inputs). • Level 3 inputs—Unobservable inputs for the asset or liability, which are supported by little or no market activity and are The following table provides the carrying value and fair value of the Company’s financial assets measured at fair value on a recurring basis as of September 30, 2015: Fair Value Measurement at September 30, 2015 Carrying Value Level 1 Level 2 Level 3 Money Market Funds $ 3,334,894 $ 3,334,894 $ - $ - US Government Agency Securities 6,551,110 - 6,551,110 - Corporate Securities 15,054,140 - 15,054,140 - Commercial Paper 1,999,365 - 1,999,365 - Subtotal $ 23,604,615 $ - $ 23,604,615 $ - $ 26,939,509 $ 3,334,894 $ 23,604,615 $ - Foreign Currency Translation and Transactions These condensed consolidated financial statements are presented in U.S. Dollars (“USD”), the reporting currency of the Company. For the financial statements of the Company’s foreign subsidiary, whose functional currency is the EURO, foreign currency asset and liability amounts, are translated into USD at end-of-period exchange rates. Foreign currency income and expenses are translated at average exchange rates in effect during the year. Translation gains and losses are included in other comprehensive income (loss). The Company has intercompany loans between the parent company based in New Jersey and its German subsidiary. Effective October 1, 2014, the Company assessed and determined that the intercompany loans outstanding are not expected to be repaid in the foreseeable future and the nature of the funding advanced is of a long-term investment nature. As such, beginning October 1, 2014, unrealized foreign exchange movements related to long-term intercompany loans are recognized in other comprehensive income (loss). Foreign currency exchange transaction gain (loss) is the result of re-measuring transactions denominated in a currency other than the functional currency of the entity recording the transaction. Segment and Geographic Information The Company operates in one business segment. The Company reported revenues of $35,947 and $187,184 for the three and nine months ended September 30, 2015, respectively. Of the Company’s revenues for the three and nine months ended September 30, 2015, $33,741 and $180,566, respectively, were attributable to its European and Middle East operations, which are based in Germany. Of the Company’s revenues for the three and nine month ended September 30, 2014, $50,970 and $102,902 respectively, were attributable to its European operations. Total assets at September 30, 2015 were $39,306,582, of which $38,257,032 were located in the United States, with the remainder in Germany. Net property and equipment at September 30, 2015 was $41,075, of which $11,754 was located in the United States, with the remainder located in Germany. Prepaid Expenses Prepaid expenses consist of payments made in advance to vendors relating to service contracts for clinical trial development, manufacturing, preclinical development and insurance policies. These advanced payments are amortized to expense either as services are performed or over the relevant service period using the straight-line method. Inventories, net Inventories are valued at the lower of cost or market on a first in, first out basis. Inventories consist of raw materials (including labeling and packaging), work-in-process, and finished goods, if any, for the Neutrolin product. Inventories consist of the following: September 30, 2015 December 31, 2014 Raw materials $ 245,358 $ 293,976 Work in process 542,812 341,807 Finished goods 85,978 2,246 Inventory reserve (175,000) (175,000) Total $ 699,148 $ 463,029 Accrued Expenses Accrued expenses consist of the following: September 30, 2015 December 31, 2014 Professional and consulting fees $ 318,721 $ 225,726 Accrued payroll and payroll taxes 477,726 13,393 Clinical trial and manufacturing development 366,459 — Market research 108,320 137,345 Monitoring program fees 56,432 82,861 Statutory taxes 69,736 34,548 Other 52,763 27,652 Total $ 1,450,157 $ 521,525 Revenue Recognition The Company recognizes revenue in accordance with SEC Staff Accounting Bulletin (“SAB”) No. 101, Revenue Recognition in Financial Statements Revenue Recognition Revenue Recognition. Deferred Revenue In August 2014, the Company entered into an exclusive distribution agreement (the “Agreement”) with Wonik Corporation, a South Korean company, to market, sell and distribute Neutrolin for hemodialysis and oncolytic patients upon receipt of regulatory approval in South Korea (the “Territory”). Upon execution of the Agreement, Wonik paid the Company a non-refundable $50,000 payment and will pay an additional $50,000 upon receipt of the product registration necessary to sell Neutrolin in the Territory. The term of the agreement commenced on August 8, 2014 and will continue for three years after the first commercial sale of Neutrolin in the Territory. The non-refundable up-front payment has been recorded as deferred revenue and will be recognized as revenue on a straight-line basis over the contractual term of the Agreement. Loss Per Common Share Basic loss per common share excludes any potential dilution and is computed by dividing net loss by the weighted average number of common shares outstanding during the period. Diluted net loss per common share reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that then shared in the earnings of the entity. For the three and nine months ended September 30, 2015 and 2014, basic loss per common share is calculated by dividing net loss available to common shareholders by the number of weighted average common shares issued and outstanding. Diluted loss per common share is calculated by dividing net loss available to common shareholders by the weighted average number of common shares issued and outstanding for the period, plus amounts representing the dilutive effect from the exercise of stock options and warrants and the conversion of convertible preferred stock, as applicable. The Company calculates dilutive potential common shares using the treasury stock method, which assumes the Company will use the proceeds from the exercise of stock options and warrants to repurchase shares of common stock to hold in its treasury stock reserves. September 30, 2015 2014 Series B non-voting convertible preferred stock - 454,546 Series C non-voting convertible preferred stock 2,865,000 3,340,000 Series D non-voting convertible preferred stock 1,479,240 1,479,240 Series E non-voting convertible preferred stock 1,959,759 2,021,358 Shares underlying outstanding warrants 4,422,188 11,571,233 Shares underlying outstanding stock options 3,689,545 3,653,500 Total 14,415,732 22,519,877 Each outstanding series of convertible preferred stock is considered to be a participating security under ASC 260, Earnings Per Share The following table is the calculation of the basic and diluted net loss per share of common stock: Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Loss Per Common Share – Basic and Diluted: Net loss $ (4,688,476) $ (5,035,117) $ (14,321,245) $ (18,239,118) Less: Dividends on participating securities - (27,125) (33,121) (81,727) Net loss available to common shareholders – basic and diluted $ (4,688,476) $ (5,062,242) $ (14,354,366) $ (18,320,845) Weighted average common shares outstanding – basic and diluted 34,585,543 22,080,673 30,082,478 21,161,532 Net loss per common share – basic and diluted $ (0.14) $ (0.23) $ (0.48) $ (0.87) Stock-Based Compensation The Company accounts for stock options granted to employees, officers and directors according to ASC No. 718, “Compensation — Stock Compensation” Stock compensation expense is recognized by applying the expected forfeiture rate during the vesting period to the fair value of the award. The estimation of the number of stock awards that will ultimately vest requires judgment, and to the extent actual results or updated estimates differ from the Company’s current estimates, compensation expense may need to be revised. The Company considers many factors when estimating expected forfeitures for stock awards granted to employees, officers and directors, including types of awards, employee class, and an analysis of historical forfeitures. The Company accounts for stock options granted to non-employees on a fair value basis using the Black-Scholes option pricing model in accordance with ASC 718 and ASC No. 505-50, “Equity-Based Payments to Non-Employees” Research and Development Research and development costs are charged to expense as incurred. Research and development costs include fees associated for operational consultants, contract clinical research organizations, contract manufacturing organizations, contract laboratory research organizations and contract central testing laboratories, licensing activities, clinical site fees, and allocated executive, human resources and facilities expenses, among others. The Company accrues for costs incurred as the services are being provided.

3. Stockholders' Equity

3. Stockholders' Equity	9 Months Ended
	Sep. 30, 2015
STOCKHOLDERS' EQUITY
Stockholders' Equity	Common Stock On April 8, 2015, the Company entered into an At-the-Market Issuance Sales Agreement (the “Sales Agreement”) with MLV & Co. LLC (“MLV”) under which the Company may issue and sell up to $40.0 million of shares of its common stock from time to time through MLV acting as agent, subject to limitations imposed by the Company, such as the number or dollar amount of shares registered under the registration statement to which the offering relates. When the Company wishes to issue and sell common stock under the Sales Agreement, it notifies MLV of the number of shares to be issued, the dates on which such sales are anticipated to be made, any minimum price below which sales may not be made and other sales parameters as the Company deems appropriate. MLV is entitled to a commission of up to 3% of the gross proceeds from the sale of common stock sold under the Sales Agreement. The shares of common stock to be sold under the Sales Agreement are registered under an effective registration statement filed with the SEC. During the nine months ended September 30, 2015, the Company issued 4,723,191 shares of common stock under the Sales Agreement and realized net proceeds of approximately $27,242,752. During the nine months ended September 30, 2015, · 150,000 shares of common stock upon exercise of warrants with an exercise price of $0.90 per share; · 125,000 shares of common stock upon exercise of warrants with an exercise price of $0.40 per share; · 353,500 shares of common stock upon exercise of warrants with an exercise price of $2.50 per share; and · 3,953,283 shares of common stock upon exercise of warrants with an exercise price of $3.4375 per share. During the nine months ended September 30, 2015, the Company issued 2,158,033 shares of its common stock upon cashless exercise of 2,597,591 warrants. During the nine months ended September 30, 2015, the Company issued 499,955 shares of its common stock upon exercise of 499,955 stock options at a weighted average exercise price of $0.99 per share, resulting in gross proceeds of $492,960 to the Company. During the nine months ended September 30, 2015, the Company issued 454,546 shares of its common stock upon conversion of 454,546 shares of the Series B non-voting preferred stock. During the nine months ended September 30, 2015, the Company issued an aggregate of 425,000 shares of its common stock upon conversion of an aggregate of 42,500 shares of the Series C-3 non-voting preferred stock. During the nine months ended September 30, 2015, the Company issued 61,598 shares of its common stock upon conversion of 2,817 shares of the Series E non-voting preferred stock. During the nine months ended September 30, 2015, wages in an aggregate amount of $50,000 were converted into 10,728 shares of its common stock by an officer of the Company at prices per share of $3.10 - $8.55. Preferred Stock and Warrants Under the terms of the Company’s Amended and Restated Certificate of Incorporation, as amended, the Company’s board of directors is authorized to issue up to 2,000,000 shares of preferred stock in one or more series without stockholder approval. The Company’s board of directors has the discretion to determine the rights, preferences, privileges and restrictions, including voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences, of each series of preferred stock. Of the 2,000,000 shares of preferred stock authorized, the Company’s board of directors has designated (all with par value of $0.001 per share) the following: As of September 30, 2015 As of December 31, 2014 Preferred Shares Outstanding Liquidation Preference (Per Share) Total Liquidation Preference Preferred Shares Outstanding Liquidation Preference (Per Share) Total Liquidation Preference Series B - $ - $ - 454,546 $ 0.001 $ 455 Series C-2 150,000 10.000 1,500,000 150,000 10.000 1,500,000 Series C-3 136,500 10.000 1,365,000 179,000 10.000 1,790,000 Series D 73,962 21.000 1,553,202 73,962 21.000 1,553,202 Series E 89,623 49.200 4,409,452 92,440 49.200 4,548,048 Total 450,085 $ 8,827,654 949,948 $ 9,391,705 Stock Options During the nine months ended September 30, 2015, the Company granted ten-year non-qualified stock options under the 2013 Plan covering an aggregate of 640,000 shares of the Company’s common stock to its officers, directors and consultants. In August 2015, the Company entered into a Release of Claims and Severance Modification Agreement with Randy Milby (See Note 5), the Company’s CEO, due to Mr. Milby’s anticipated termination of employment. As a result, the Company recorded a total of $507,341 compensation expense for the incremental value of an aggregate of 762,500 options during the nine months ended September 30, 2015 using the Black-Scholes option pricing model with the following assumptions: Expected term (years) 0.25 – 5 Volatility 94% - 97% Dividend yield 0.0% Risk-free interest rate 0.05% - 1.61% During the three and nine months ended September 30, 2015 total compensation expense was $921,153 and $2,908,855(including $507,341 expense recorded for the modification of Mr. Milby’s stock options), respectively and $166,439 and $1,942,192 for the three and nine months ended September 30, 2014, respectively. The fair value of the grants at grant dates is determined using the Black-Scholes option pricing model with the following assumptions for the nine months ended September 30, 2015: Expected term (years) 5 – 10 Volatility 93% - 94% Dividend yield 0.0% Risk-free interest rate 1.47% - 2.26% Weighted-average fair value of options granted during the period $ 3.46 The Company estimated the expected term of the stock options granted based on anticipated exercises in future periods. The expected term of the stock options granted to consultants is based upon the full term of the respective option agreements. Prior to 2015, the expected volatility used in the valuation of the Company’s stock options was based on the historical volatility of publicly traded peer group companies due to the limited trading history of the Company’s common stock. Beginning in the first quarter of 2015, the expected stock price volatility for the Company’s stock options is calculated based on the historical volatility since the initial public offering of the Company’s common stock in March 2010. The expected dividend yield of 0.0% reflects the Company’s current and expected future policy for dividends on the Company’s common stock. To determine the risk-free interest rate, the Company utilized the U.S. Treasury yield curve in effect at the time of grant with a term consistent with the expected term of the Company’s awards. At September 30, 2015, a summary of the Company’s stock option activity and related information is as follows: Shares Weighted Average Outstanding at beginning of period 3,664,500 $ 1.25 Exercised (499,955) $ 0.99 Forfeited (115,000) $ 2.08 Expired - $ - Granted 640,000 $ 4.60 Outstanding at end of period 3,689,545 $ 1.84 Options exercisable 3,151,712 $ 1.46 Weighted average remaining contractual life of stock options outstanding (years) 7.8 Weighted average remaining contractual life of stock options exercisable (years) 7.6 Weighted average vesting period over which total compensation expense related to non-vested options not yet recognized (years) 0.7 Aggregate intrinsic value of stock options exercised $ 3,260,728 Aggregate intrinsic value of stock options outstanding $ 2,325,974 Compensation expense related to non-vested options not yet recognized $ 956,462 The aggregate intrinsic value is calculated as the difference between the exercise prices of the underlying options and the quoted closing price of the common stock of the Company at the end of the reporting period for those options that have an exercise price below the quoted closing price. Warrants On March 2, 2015, the Company’s board of directors approved an extension to April 30, 2015 of the expiration date of the Company’s publicly traded warrants which resulted in deemed dividend of $33,121. In March 2015, the Company issued two warrants exercisable for an aggregate of up to 283,400 common shares with an exercise price of $7.00 per share and a term of five years as a result of entering into a backstop agreement with Manchester Securities Corp. (“Manchester”) (See Note 4). Additionally, the expiration date of March 24, 2015 of warrants to purchase 390,720 shares of common stock issued to Manchester in connection with the Company’s initial public offering (“IPO”) was extended by one year to March 24, 2016. The Company recorded non-cash general and administrative expense of $1,583,252 for these warrants using the Black-Scholes option pricing model with the following assumptions: Expected term (years) 1 - 5 Volatility 75.81% - 104.08% Dividend yield 0.0% Risk-free interest rate 0.01% - 1.61% During the nine months ended September 30, 2015, the Company issued 774 warrants upon the exercise of a unit warrant related to the IPO. These warrants were subsequently exercised resulting in the issuance of 774 shares of common stock and gross proceeds of $2,661 to the Company. During the nine months ended September 30, 2015, the Company extended the expiration date for an aggregate of 38,400 warrants with an exercise price of $3.4375. The Company accounted for this transaction as a modification of warrants and recorded additional paid in capital and non-cash general and administrative expense in the amount of $112,982. The warrants were valued using the Black-Scholes option pricing model with the following assumptions: Expected term (days) 5 Volatility 88.17% Dividend yield 0.0% Risk-free interest rate .003% The following table is the summary of warrant activity for the nine months ended September 30, 2015: Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life Outstanding at beginning of period 11,520,762 $ 1.99 2.57 Granted 284,174 $ 6.99 4.93 Expired (203,374) $ 3.44 - Exercised (7,179,374) $ 2.27 - Outstanding at end of period 4,422,188 $ 1.80 2.50 Short Swing Profit Recovery In June 2015, a member of the board of directors of the Company paid a total of $28,594 to the Company representing the disgorgement of short swing profits under Section 16(b) under the Exchange Act. The amount was recorded as additional paid in capital.

4. Related Party Transactions

4. Related Party Transactions	9 Months Ended
	Sep. 30, 2015
Related Party Transactions [Abstract]
Related Party Transactions	On March 3, 2015, the Company entered into a backstop agreement with an existing institutional investor, Manchester, a wholly owned subsidiary of Elliott Associates, L.P., and a beneficial holder of more than 5% of the Company’s outstanding common stock. Pursuant to the backstop agreement, Manchester agreed to lend the Company, at its request, up to $4,500,000 less the dollar amount of gross proceeds received by the Company upon the exercise of warrants to purchase common stock issued in connection with its IPO on or before April 30, 2015, provided that the loan could not exceed $3,000,000. The Company had received approximately $5.7 million through March 31, 2015 from the exercise of warrants issued in connection with its IPO therefore, the Company did not access the loan and the loan expired on April 30, 2015. Additionally, the Company granted Manchester the right for as long as it or its affiliates hold any of the Company’s common stock or securities convertible into its common stock the right to appoint up to two members to the Company’s board of directors and/or to have up to two observers attend board meetings in a non-voting capacity. As of September 30, 2015, one board member had been appointed to the Company’s board of directors under this provision. On April 7, 2015, the Company entered into a one year agreement with a consultant to advise management with their investment banking relationships and assist in the negotiations with potential external parties, if applicable. The consultant is a member of the board of directors of Sterling HSA which was founded by the Chairman of the Board of Directors of the Company. The arrangement calls for a $30,000 retainer, a monthly fee of $6,000, and a multiple of the price per share upon a merger or acquisition or a percentage of any strategic partnership. Either party can terminate the agreement with a 30 day advance notice. Upon termination, the Company is liable for any services rendered through the termination date. This agreement was terminated at the end of August 2015.

5. Commitments and Contingencie

5. Commitments and Contingencies	9 Months Ended
	Sep. 30, 2015
Commitments and Contingencies Disclosure [Abstract]
Commitments and Contingencies	Contingency Matters In February 2007, Geistlich Söhne AG für Chemische Industrie, Switzerland (“Geistlich”) brought an action against the European Sodemann Patent covering the Company’s Neutrolin product candidate, which is owned by ND Partners, LLC (“NDP”) and licensed to the Company pursuant to the License and Assignment Agreement between the Company and NDP. This action was brought at the Board of the European Patent Office (“EPO”) opposition division (the “Opposition Board”) based upon alleged lack of inventiveness in the use of citric acid and a pH value in the range of 4.5 to 6.5 with having the aim to provide an alternative lock solution through having improved anticoagulant characteristics compared to the lock solutions of the prior art. The Opposition Board rejected the opposition by Geistlich. On August 27, 2008, Geistlich appealed the court's ruling, alleging the same arguments as presented during the opposition proceedings. The Company filed a response to the appeal of Geistlich on March 25, 2009 requesting a dismissal of the appeal and maintenance of the patent as granted. On November 28, 2012, the Board of Appeals of the EPO (the “Appeals Board”) held oral proceedings and verbally upheld the counterpart of the Sodemann Patent covering Neutrolin, but remanded the proceeding to the lower court to consider restricting certain claims of the counterpart of the Sodemann Patent. The Company received the Appeals Board’s final written decision on March 28, 2013, which was consistent with the oral proceedings. In a letter dated September 30, 2013, the Company was notified that the opposition division of the EPO reopened the proceedings before the first instance and gave their preliminary non-binding opinion that the patent as amended during the appeal proceedings fulfills the requirements of clarity, novelty, and inventive step, and invited the parties to provide their comments and/or requests by February 10, 2014. The Company filed its response on February 3, 2014 to request that the patent be maintained as amended during the appeal proceedings. Geistlich did not provide any filing by February 10, 2014; however, the Opposition Board granted Geistlich an extension to respond by the end of July 2014 because its representative did not receive the September 30, 2013 letter due to a change of address. Geistlich did not file a further statement within the required timeline. On November 5, 2014, the Opposition Division at the EPO issued the interlocutory decision to maintain the patent on the basis of the claims as amended during the appeal proceedings. This decision became final as no further appeal was lodged by Geistlich. On September 9, 2014, the Company filed in the District Court of Mannheim, Germany a patent infringement action against TauroPharm GmbH and Tauro-Implant GmbH as well as their respective CEOs (the “Defendants”) claiming infringement of the Company’s European Patent EP 1 814 562 B1, which was granted by the EPO on January 8, 2014 (the “Prosl European Patent”). The Prosl European Patent covers a low dose heparin catheter lock solution for maintaining patency and preventing infection in a hemodialysis catheter. In this action, the Company claims that the Defendants infringe on the Prosl European Patent by manufacturing and distributing catheter locking solutions to the extent they are covered by the claims of the Prosl European Patent. The Company believes that its patent is sound, and is seeking injunctive relief and raising claims for information, rendering of accounts, calling back, destruction and damages. Separately, TauroPharm has filed an opposition with the EPO against the Prosl European Patent alleging that it lacks novelty and inventive step. The Company cannot predict what other defenses the Defendants may raise, or the ultimate outcome of either of these related matters. In the same complaint against the same Defendants, the Company also alleged an infringement (requesting the same remedies) of NDP’s utility model DE 20 2005 022 124 U1 (the “Utility Model”), which the Company believes is fundamentally identical to the Prosl European Patent in its main aspects and claims. The Court separated the two proceedings and the Prosl European Patent and the Utility Model claims are now being tried separately. TauroPharm has filed a cancellation action against the Utility Model before the German Patent and Trademark Office based on the similar arguments as those in the opposition against the Prosl European Patent. On March 27, 2015, the District Court held a hearing to evaluate whether the Utility Model has been infringed by TauroPharm in connection with the manufacture, sale and distribution of its TauroLock-HEP100 TM TM The Court issued its decisions on May 8, 2015 staying both proceedings. In its decisions, the Court found that the commercialization by TauroPharm in Germany of its TauroLock catheter lock solutions Hep100 and Hep500 infringes both the Prosl European Patent and the Utility Model and further that there is no prior use right that would allow TauroPharm to continue to make, use or sell its product in Germany. However, the Court declined to issue an injunction in favor of the Company that would preclude the continued commercialization by TauroPharm based upon its finding that there is a sufficient likelihood that the EPO, in the case of the Prosl European Patent, or the German Patent and Trademark Office (the “German PTO”), in the case of the Utility Model, may find that such patent or utility model is invalid. Specifically, the Court noted the possible publication of certain instructions for product use that may be deemed to constitute prior art. As such, the District Court determined that it will defer any consideration of the request by the Company for injunctive and other relief until such time as the EPO or the German PTO has ruled on the underlying validity of the Prosl European Patent and the Utility Model. Both the opposition proceedings against the Prosl European Patent before the EPO and the cancellation action against the Utility Model before the German PTO are ongoing. The EPO has scheduled a hearing for the end of 2015. The Company expects a decision from the EPO by November 25, 2015, and that decision would be subject to appeal. However, in its preliminary consideration of the matter, the EPO (and the German Patent and Trademark Office) regarded the patent as not inventive or novel due to publication of prior art. While the Company continues to believe that the referenced publication and instructions for use do not, in fact, constitute prior art and that the Prosl European Patent and the Utility Model validly claim inventions that will be found to be such by the EPO and the German PTO, there can be no assurance that the Company will prevail in this matter. The Company does not expect a decision from the German PTO in the Utility Model matter before late 2015 or early 2016, with any such decision also being subject to appeal. On January 16, 2015, the Company filed a complaint against TauroPharm GmbH and its managing directors in the District Court of Cologne, Germany. In the complaint, the Company alleges violation of the German Unfair Competition Act by TauroPharm for the unauthorized use of its proprietary information obtained in confidence by TauroPharm. The Company alleges that TauroPharm is improperly and unfairly using its proprietary information relating to the composition and manufacture of Neutrolin, in the manufacture and sale of TauroPharm’s products TauroLock TM In connection with the aforementioned patent and utility model infringement proceedings against TauroPharm, the Company was required by the District Court Mannheim to provide a security deposit of approximately $132,000 to cover legal fees in the event TauroPharm is entitled to reimbursement of these costs. The Company recorded the deposit as restricted cash for the nine months ended September 30, 2015. The Company furthermore had to provide a deposit in the amount of €36,000 ($39,559) in connection with the unfair competition proceedings in Cologne. On July 7, 2015, a putative class action lawsuit was commenced against the Company and certain of its current and former officers in the United States District Court for the District of New Jersey, captioned Li v. Cormedix Inc., et al. Commitments Manufacturing Navinta LLC, a U.S.-based API developer, provides API manufacturing (manufactured in India at an FDA-compliant facility) and a Drug Master File for CRMD003, pursuant to a supply agreement dated December 7, 2009 (the “Navinta Agreement”). The Navinta Agreement provides that Navinta will supply taurolidine (the API for CRMD003) to the Company on an exclusive worldwide basis in the field of the prevention and treatment of human infection and/or dialysis so long as the Company purchased a minimum of $350,000 of product from Navinta by December 30, 2010, which the Company achieved, and following the Company’s first commercial sale of a product incorporating taurolidine, purchases a minimum of $2,250,000 of product on an annual basis for five years. The Company did not purchase the required amount in 2014 and as a result, lost its exclusive manufacturing rights. The Company is also required to make certain cash payments to Navinta upon the achievement of certain sales-based milestones which is based on a tiered approach and does not commence until the Company achieves a designated net sales threshold. The maximum aggregate amount of such payments, assuming achievement of all milestones, is $1,975,000 over five years. On March 24, 2015, the Company and Navinta LLC entered into an amendment to the Taurolidine Supply Agreement to extend the term of the Agreement to March 31, 2016 and to lower the price per kilogram of API that the Company purchases from Navinta LLC under the Navinta Agreement. The Company also agreed to purchase a minimum amount of product from Navinta LLC during 2015, which replaces the prior minimum purchase requirement. The Navinta Agreement may be terminated by either party upon 30 days written notice. On April 9, 2015, the Company announced a program aimed at reducing the cost of goods of Neutrolin through a more efficient, custom synthesis of the active ingredient taurolidine. As part of that program, on April 8, 2015, the Company entered into a Preliminary Services Agreement with [RC] 2 The Company is also working with RC2 under several service agreements for the manufacture of clinical supplies to support its Phase 3 clinical trials for an aggregate amount of $1.9 million. As of September 30, 2015, approximately $464,000 of services was completed by RC2 and $45,000 was prepaid. The Company recognized research and development expense of approximately $436,000 and $464,000 for the three and nine months ended September 30, 2015, respectively. The Company may terminate these agreements upon 30 days written notice and is only obligated for project costs and reasonable project shut down costs provided through the date of termination. Clinical and Regulatory On July 6, 2015, the Company entered into an Letter of Agreement (“LOA”) with PPD Development, LP (“PPD”) under which PPD and/or one or more of its global affiliates would begin to provide services related to the Company’s Phase 3 prospective, multicenter, double-blind, randomized active control study to demonstrate the safety and effectiveness of Neutrolin in preventing catheter-related bloodstream infections in subjects receiving hemodialysis therapy as treatment for end stage renal disease (the “Project”). Following the execution of the LOA, the Company paid PPD $164,766 as an advance payment for services provided under the LOA and for the reimbursement of indirect pass-through expenses related to the provision of those services. As of September 30, 2015, PPD had completed 75% of the services and the Company had therefore recognized expense in the three and nine months ended September 30, 2015 in an amount equal to 75% of the advance payment. Either party may terminate the agreement upon 30 days written notice to the other party. On July 28, 2015, the Company entered into an amendment to the original LOA (“Amendment #1”) to revise and expand the scope of services provided by PPD. These services are primarily related to activities in connection with the identification, activation and management of 70 U.S. sites for the clinical trials for the Project described above. The services to be provided under Amendment #1 amounted to $2.75 million, including the amount in the original LOA. Through September 30, 2015, the services provided by PPD under Amendment #1 amounted to approximately $366,000. The Company recognized this amount as research and development expense during the three and nine months ended September 30, 2015. In-Licensing In 2008, the Company entered into a License and Assignment Agreement (the “NDP License Agreement”) with NDP. Pursuant to the NDP License Agreement, NDP granted the Company exclusive, worldwide licenses for certain antimicrobial catheter lock solutions, processes for treating and inhibiting infections, a biocidal lock system and a taurolidine delivery apparatus, and the corresponding United States and foreign patents and applications (the “NDP Technology”). The Company acquired such licenses and patents through its assignment and assumption of NDP’s rights under certain separate license agreements by and between NDP and Dr. Hans-Dietrich Polaschegg, Dr. Klaus Sodemann and Dr. Johannes Reinmueller. As consideration in part for the rights to the NDP Technology, the Company paid NDP an initial licensing fee of $325,000 and granted NDP a 5% equity interest in the Company, consisting of 39,980 shares of the Company’s common stock. In addition, the Company is required to make payments to NDP upon the achievement of certain regulatory and sales-based milestones. Certain of the milestone payments are to be made in the form of shares of common stock currently held in escrow for NDP, and other milestone payments are to be paid in cash. The maximum aggregate number of shares issuable upon achievement of milestones is 145,543 shares. During the year ended December 31, 2014, a certain milestone was achieved resulting in the release of 36,386 shares held in escrow. The number of shares held in escrow as of September 30, 2015 is 109,157 shares of common stock. The maximum aggregate amount of cash payments upon achievement of milestones is $3,000,000 with $2,500,000 remaining at September 30, 2015. Events that trigger milestone payments include but are not limited to the reaching of various stages of regulatory approval and upon achieving certain worldwide net sales amounts. The NDP License Agreement may be terminated by the Company on a country-by-country basis upon 60 days prior written notice. If the NDP License Agreement is terminated by either party, the Company’s rights to the NDP Technology will revert back to NDP. On January 30, 2008, the Company also entered into an Exclusive License and Consulting Agreement with Dr. Polaschegg (the “Polaschegg License Agreement”). The Polaschegg License Agreement replaced the original license agreement between NDP and Dr. Polaschegg that the Company was assigned and the Company assumed under the NDP License Agreement. Pursuant to the Polaschegg License Agreement, Dr. Polaschegg granted the Company an exclusive, worldwide license for a certain antimicrobial solution and certain taurolidine treatments and the corresponding United States patent applications (the “Polaschegg Technology”), and agreed to provide the Company with certain consulting services. As consideration for the rights to the Polaschegg Technology, the Company paid Dr. Polaschegg an initial payment of $5,000 and agreed to pay Dr. Polaschegg certain royalty payments ranging from 1% to 3% of the net sales of the Polaschegg Technology. The Polaschegg License Agreement also sets forth certain minimum royalty payments (on an annual basis) to be made to Dr. Polaschegg in connection with the Polaschegg Technology, which payments range from $10,000 to $45,000. As compensation for Dr. Polaschegg’s consulting services to be provided under the Polaschegg License Agreement, Dr. Polaschegg was paid €200 per hour for services consisting of scientific work and €250 per hour for services consisting of legal work. The Company may terminate the Polaschegg License Agreement with respect to any piece of the Polaschegg Technology upon 60 days notice. If the Polaschegg License Agreement is terminated with respect to any piece of the Polaschegg Technology by either party, all rights with respect to such portion of the Polaschegg Technology will revert to Dr. Polaschegg. During the three and nine months ended September 30, 2015, the Company expensed $7,500 and $22,500, respectively, in connection with the Polaschegg License Agreement. Other On August 3, 2015, the Company entered into a Release of Claims and Severance Modification with Randy Milby, its Chief Executive Officer, due to the anticipated termination of Mr. Milby’s employment. In exchange for the release of various claims by Mr. Milby against the Company, including claims related to his employment with Company and the termination of same and claims for additional compensation or benefits other than the compensation and benefits set forth in his employment agreement, the Company agreed to amend Mr. Milby’s employment agreement, dated as of March 31, 2014, to specify that Mr. Milby may not compete against the Company by engaging in any business involving the development or commercialization of (i) a preventive anti-infective product that would be a direct competitor of Neutrolin or (ii) a product containing taurolodine. The non-compete term did not change and remains at 12 months following termination of his employment. The employment agreement was also amended to allow Mr. Milby a period in which to exercise all vested options and warrants until the later of 60 months following the termination date of his employment or 60 months following the date on which his service on the Company’s Board of Directors ends, provided in no event shall he be able to exercise after the respective expiration date of any stock option or warrant. During the three and nine months ended September 30, 2015, the Company recorded non-cash expense of $507,341 as a result of this modification. Pursuant to the terms of his employment agreement, Mr. Milby will be entitled to receive his base salary and benefits for a period of 12 months following the effective date of the termination of his employment, or, in the case of benefits, until such time as he receives equivalent coverage and benefits under plans and programs of a subsequent employer if such receipt is prior to the expiration of the 12-month period. To the extent any of the aforementioned benefits cannot be provided to former employees, the Company will pay Mr. Milby a lump-sum payment in the amount necessary to allow Mr. Milby to purchase the equivalent benefits. The Company accrued $325,000 of severance pay during the three and nine months ended September 30, 2015. The Company entered into sublease for 4,700 square feet of office space in Bedminster, New Jersey, which sublease runs from April 1, 2015 until March 31, 2018. Rent is $5,000 per month plus occupancy costs such as utilities, maintenance and taxes. In accordance with the lease agreement, the Company has deposited $5,000 with the landlord, the equivalent of one month rent. The Company’s subsidiary entered into a lease agreement for its offices in Fulda, Germany with ITZ GmbH. The lease has a term of 36 months which commenced on September 1, 2013 for a base monthly payment of €498. The total 36 month lease obligation is approximately €17,900 ($20,000). Under the Company’s current lease agreements, the total remaining lease obligation as of September 30, 2015 is set forth below: 2015 $ 16,864 2016 66,236 2017 60,784 2018 15,000 Total $ 158,884

6. Subsequent Events

6. Subsequent Events	9 Months Ended
	Sep. 30, 2015
Subsequent Events [Abstract]
Subsequent Events	On October 28, 2015 the Company signed an agreement for central laboratory services to support the Company’s Phase 3 clinical trial in hemodialysis patients. The agreement is for $152,800 and is scheduled to run from November 2015 to March 2017. The Company provided JMI Laboratories with an advance payment of $30,500 in November 2015. The laboratory will perform the following key activities over the life of this agreement: specimens from 160 patients (average 2 isolates per patient) will be analyzed for identification and confirmation of the isolates, antimicrobial susceptibility testing and storage for up to three years after the study completion. On November 5, 2015, the Company terminated the Polaschegg License Agreement with respect to any piece of the Polaschegg Technology. Upon the termination of the Polaschegg License Agreement with respect to any piece of the Polaschegg Technology by either party, all rights with respect to such portion of the Polaschegg Technology will revert to Dr. Polaschegg.

2. Summary of Significant Acc13

2. Summary of Significant Accounting Policies (Policies)	9 Months Ended
	Sep. 30, 2015
Accounting Policies [Abstract]
Liquidity, Risks and Uncertainties	The Company’s operations are subject to a number of factors that can affect its operating results and financial condition. Such factors include, but are not limited to: the results of clinical testing and trial activities of the Company’s product candidates; the ability to obtain regulatory approval to market the Company’s products; competition from products manufactured and sold or being developed by other companies, the price of, and demand for, Company products; the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products; and the Company’s ability to raise capital. To date, the Company’s commercial operations have not generated enough revenues to make the Company profitable. Based on the current development plans for Neutrolin in both the United States (“U.S.”) and foreign markets (including the planned hemodialysis Phase 3 clinical trials in the U.S.) and on the current revenue assumptions for Neutrolin in approved markets, management believes that the existing cash will be sufficient to fund its operations for at least the next 12 months following this balance sheet date. Nevertheless, the Company’s continued operations, including the completion of its planned Phase 3 clinical trial for Neutrolin in hemodialysis patients in the U.S., will depend on its ability to raise additional capital through potential sources such as equity and/or debt financings, strategic relationships, and/or out-licensing or distribution arrangements of its products. The Company also plans to conduct an oncology/total parenteral nutrition patient Phase 3 clinical trial in the U.S. for which additional funds over and above the funds needed for the hemodialysis Phase 3 clinical trial will be required to complete that study. However, the Company can provide no assurances that such financing or strategic relationships will be available on acceptable terms, or at all. If the Company is unable to raise sufficient capital or find strategic partners, there would be a material adverse effect on its business. Further, the Company expects to incur increases in its cash use from operations as it continues to commercialize Neutrolin internationally, increase its business development activities, incur legal costs to defend its intellectual property and seek FDA approval of Neutrolin in the U.S.
Use of Estimates	The preparation of financial statements in conformity with GAAP requires management to make certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates.
Basis of Consolidation	The condensed consolidated financial statements include the accounts of the Company and CorMedix Europe GmbH, a wholly owned subsidiary. All significant intercompany accounts and transactions have been eliminated in consolidation.
Cash and Cash Equivalents	The Company considers all highly liquid instruments with an original maturity of 90 days or less at the time of purchase to be cash equivalents. Cash and cash equivalents consist of deposits and other interest bearing accounts, the balances of which, at times, may exceed federally insured limits.
Short term investments	The Company determines the appropriate classification of marketable securities at the time of purchase and reevaluates such designation as of each balance sheet date. Investments in marketable debt and equity securities classified as available-for-sale are reported at fair value. Fair values of the Company’s investments are determined using quoted market prices in active markets for identical assets or liabilities or quoted prices for similar assets or liabilities or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Changes in fair value that are considered temporary are reported net of tax in other comprehensive income (loss). Realized gains and losses, amortization of premiums and discounts and interest and dividends earned are included in income (expense) on the condensed consolidated statements of operations and comprehensive income (loss). The cost of investments for purposes of computing realized and unrealized gains and losses is based on the specific identification method. For declines in the fair value of equity securities that are considered other-than-temporary, impairment losses are charged to other (income) expense, net. The Company considers available evidence in evaluating potential impairments of its investments, including the duration and extent to which fair value is less than cost. There were no deemed permanent impairments at September 30, 2015. The Company’s marketable securities are highly liquid and consist of U.S. government agency securities, high-grade corporate obligations and commercial paper with original maturities of more than 90 days. As of September 30, 2015, all of the Company’s investments had contractual maturities which were less than one year. The following table summarizes the amortized cost, unrealized gains and losses and the fair value at September 30, 2015 of the Company’s financial assets that are measured on a recurring basis: Amortized Cost Gross Unrealized Losses Gross Unrealized Gains Fair Value Money Market Funds included in Cash Equivalents $ 3,334,894 $ - $ - $ 3,334,894 US Government Agency Securities 6,550,635 (298) 773 6,551,110 Corporate Securities 15,054,267 (2,076) 1,949 15,054,140 Commercial Paper 1,999,365 - - 1,999,365 Subtotal 23,604,267 (2,374) 2,722 23,604,615 $ 26,939,161 $ (2,374) $ 2,722 $ 26,939,509
Fair value measurements	The Company’s financial instruments recorded in the consolidated balance sheets include cash and cash equivalents, accounts receivable, investment securities, accounts payable and accrued expenses. The carrying value of certain financial instruments, primarily cash and cash equivalents, accounts receivable, accounts payable, and accrued expenses approximate their estimated fair values based upon the short-term nature of their maturity dates. The Company categorizes its financial instruments into a three-level fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets (Level 1) and the lowest priority to unobservable inputs (Level 3). If the inputs used to measure fair value fall within different levels of the hierarchy, the category level is based on the lowest priority level input that is significant to the fair value measurement of the instrument. Financial assets recorded at fair value on the Company’s condensed consolidated balance sheets are categorized as follows: • Level 1 inputs—Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets. • Level 2 inputs— Significant other observable inputs (e.g., quoted prices for similar items in active markets, quoted prices for identical or similar items in markets that are not active, inputs other than quoted prices that are observable such as interest rate and yield curves, and market-corroborated inputs). • Level 3 inputs—Unobservable inputs for the asset or liability, which are supported by little or no market activity and are The following table provides the carrying value and fair value of the Company’s financial assets measured at fair value on a recurring basis as of September 30, 2015: Fair Value Measurement at September 30, 2015 Carrying Value Level 1 Level 2 Level 3 Money Market Funds $ 3,334,894 $ 3,334,894 $ — $ — US Government Agency Securities 6,551,110 — 6,551,110 — Corporate Securities 15,054,140 — 15,054,140 — Commercial Paper 1,999,365 — 1,999,365 — Subtotal $ 23,604,615 $ — $ 23,604,615 $ — $ 26,939,509 $ 3,334,894 $ 23,604,615 $ —
Foreign Currency Translation and Transactions	The Company has intercompany loans between the parent company based in New Jersey and its German subsidiary. Effective October 1, 2014, the Company assessed and determined that the intercompany loans outstanding are not expected to be repaid in the foreseeable future and the nature of the funding advanced is of a long-term investment nature. As such, beginning October 1, 2014, unrealized foreign exchange movements related to long-term intercompany loans are recognized in other comprehensive income (loss). Foreign currency exchange transaction gain (loss) is the result of re-measuring transactions denominated in a currency other than the functional currency of the entity recording the transaction.
Segment and Geographic Information	The Company operates in one business segment. The Company reported revenues of $35,947 and $187,184 for the three and nine months ended September 30, 2015, respectively. Of the Company’s revenues for the three and nine months ended September 30, 2015, $33,741 and $180,566, respectively, were attributable to its European and Middle East operations, which are based in Germany. Of the Company’s revenues for the three and nine month ended September 30, 2014, $50,970 and $102,902 respectively, were attributable to its European operations. Total assets at September 30, 2015 were $39,306,582, of which $38,257,032 were located in the United States, with the remainder in Germany. Net property and equipment at September 30, 2015 was $41,075, of which $11,754 was located in the United States, with the remainder located in Germany.
Prepaid Expenses	Prepaid expenses consist of payments made in advance to vendors relating to service contracts for clinical trial development, manufacturing, preclinical development and insurance policies. These advanced payments are amortized to expense either as services are performed or over the relevant service period using the straight-line method.
Inventories, net	Inventories are valued at the lower of cost or market on a first in, first out basis. Inventories consist of raw materials (including labeling and packaging), work-in-process, and finished goods, if any, for the Neutrolin product. Inventories consist of the following: September 30, 2015 December 31, 2014 Raw materials $ 245,358 $ 293,976 Work in process 542,812 341,807 Finished goods 85,978 2,246 Inventory reserve (175,000) (175,000) Total $ 699,148 $ 463,029
Accrued Expenses	Accrued expenses consist of the following: September 30, 2015 December 31, 2014 Professional and consulting fees $ 318,721 $ 225,726 Accrued payroll and payroll taxes 477,726 13,393 Clinical trial and manufacturing development 366,459 — Market research 108,320 137,345 Monitoring program fees 56,432 82,861 Statutory taxes 69,736 34,548 Other 52,763 27,652 Total $ 1,450,157 $ 521,525
Revenue Recognition	The Company recognizes revenue in accordance with SEC Staff Accounting Bulletin (“SAB”) No. 101, Revenue Recognition in Financial Statements Revenue Recognition Revenue Recognition.
Deferred Revenue	In August 2014, the Company entered into an exclusive distribution agreement (the “Agreement”) with Wonik Corporation, a South Korean company, to market, sell and distribute Neutrolin for hemodialysis and oncolytic patients upon receipt of regulatory approval in South Korea (the “Territory”). Upon execution of the Agreement, Wonik paid the Company a non-refundable $50,000 payment and will pay an additional $50,000 upon receipt of the product registration necessary to sell Neutrolin in the Territory. The term of the agreement commenced on August 8, 2014 and will continue for three years after the first commercial sale of Neutrolin in the Territory. The non-refundable up-front payment has been recorded as deferred revenue and will be recognized as revenue on a straight-line basis over the contractual term of the Agreement.
Loss per common share	Basic loss per common share excludes any potential dilution and is computed by dividing net loss by the weighted average number of common shares outstanding during the period. Diluted net loss per common share reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that then shared in the earnings of the entity. For the three and nine months ended September 30, 2015 and 2014, basic loss per common share is calculated by dividing net loss available to common shareholders by the number of weighted average common shares issued and outstanding. Diluted loss per common share is calculated by dividing net loss available to common shareholders by the weighted average number of common shares issued and outstanding for the period, plus amounts representing the dilutive effect from the exercise of stock options and warrants and the conversion of convertible preferred stock, as applicable. The Company calculates dilutive potential common shares using the treasury stock method, which assumes the Company will use the proceeds from the exercise of stock options and warrants to repurchase shares of common stock to hold in its treasury stock reserves. However, since their effect is anti-dilutive, the Company has excluded potentially dilutive shares. The following potentially dilutive shares have been excluded from the calculation of diluted net loss per share as their effect would be anti-dilutive. September 30, 2015 2014 Series B non-voting convertible preferred stock - 454,546 Series C non-voting convertible preferred stock 2,865,000 3,340,000 Series D non-voting convertible preferred stock 1,479,240 1,479,240 Series E non-voting convertible preferred stock 1,959,759 2,021,358 Shares underlying outstanding warrants 4,422,188 11,571,233 Shares underlying outstanding stock options 3,689,545 3,653,500 Total 14,415,732 22,519,877 Each outstanding series of convertible preferred stock is considered to be a participating security under ASC 260, Earnings Per Share The following table is the calculation of the basic and diluted net loss per share of common stock: Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Loss Per Common Share – Basic and Diluted: Net loss $ (4,688,476) $ (5,035,117) $ (14,321,245) $ (18,239,118) Less: Dividends on participating securities - (27,125) (33,121) (81,727) Net loss available to common shareholders – basic and diluted $ (4,688,476) $ (5,062,242) $ (14,354,366) $ (18,320,845) Weighted average common shares outstanding – basic and diluted 34,585,543 22,080,673 30,082,478 21,161,532 Net loss per common share – basic and diluted $ (0.14) $ (0.23) $ (0.48) $ (0.87)
Stock-Based Compensation	The Company accounts for stock options granted to employees, officers and directors according to ASC No. 718, “Compensation — Stock Compensation” Stock compensation expense is recognized by applying the expected forfeiture rate during the vesting period to the fair value of the award. The estimation of the number of stock awards that will ultimately vest requires judgment, and to the extent actual results or updated estimates differ from the Company’s current estimates, compensation expense may need to be revised. The Company considers many factors when estimating expected forfeitures for stock awards granted to employees, officers and directors, including types of awards, employee class, and an analysis of historical forfeitures. The Company accounts for stock options granted to non-employees on a fair value basis using the Black-Scholes option pricing model in accordance with ASC 718 and ASC No. 505-50, “Equity-Based Payments to Non-Employees”
Research and Development	Research and development costs are charged to expense as incurred. Research and development costs include fees associated for operational consultants, contract clinical research organizations, contract manufacturing organizations, contract laboratory research organizations and contract central testing laboratories, licensing activities, clinical site fees, and allocated executive, human resources and facilities expenses, among others. The Company accrues for costs incurred as the services are being provided.

2. Summary of Significant Acc14

2. Summary of Significant Accounting Policies (Tables)	9 Months Ended
	Sep. 30, 2015
Accounting Policies [Abstract]
Summary of short-term investments	Amortized Cost Gross Unrealized Losses Gross Unrealized Gains Fair Value Money Market Funds included in Cash Equivalents $ 3,334,894 $ - $ - $ 3,334,894 US Government Agency Securities 6,550,635 (298) 773 6,551,110 Corporate Securities 15,054,267 (2,076) 1,949 15,054,140 Commercial Paper 1,999,365 - - 1,999,365 Subtotal 23,604,267 (2,374) 2,722 23,604,615 $ 26,939,161 $ (2,374) $ 2,722 $ 26,939,509
Carrying and fair value of financial assets	Fair Value Measurement at September 30, 2015 Carrying Value Level 1 Level 2 Level 3 Money Market Funds $ 3,334,894 $ 3,334,894 $ - $ - US Government Agency Securities 6,551,110 - 6,551,110 - Corporate Securities 15,054,140 - 15,054,140 - Commercial Paper 1,999,365 - 1,999,365 - Subtotal $ 23,604,615 $ - $ 23,604,615 $ - $ 26,939,509 $ 3,334,894 $ 23,604,615 $ -
Schedule of inventories	September 30, 2015 December 31, 2014 Raw materials $ 245,358 $ 293,976 Work in process 542,812 341,807 Finished goods 85,978 2,246 Inventory reserve (175,000) (175,000) Total $ 699,148 $ 463,029
Schedule of accrued expenses	September 30, 2015 December 31, 2014 Professional and consulting fees $ 318,721 $ 225,726 Accrued payroll and payroll taxes 477,726 13,393 Clinical trial and manufacturing development 366,459 — Market research 108,320 137,345 Monitoring program fees 56,432 82,861 Statutory taxes 69,736 34,548 Other 52,763 27,652 Total $ 1,450,157 $ 521,525
Schedule of anti-dilutive securities excluded from calculation of diluted net loss per share	September 30, 2015 2014 Series B non-voting convertible preferred stock - 454,546 Series C non-voting convertible preferred stock 2,865,000 3,340,000 Series D non-voting convertible preferred stock 1,479,240 1,479,240 Series E non-voting convertible preferred stock 1,959,759 2,021,358 Shares underlying outstanding warrants 4,422,188 11,571,233 Shares underlying outstanding stock options 3,689,545 3,653,500 Total 14,415,732 22,519,877
Calculation of basic and diluted net loss per share of common stock	Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Loss Per Common Share – Basic and Diluted: Net loss $ (4,688,476) $ (5,035,117) $ (14,321,245) $ (18,239,118) Less: Dividends on participating securities - (27,125) (33,121) (81,727) Net loss available to common shareholders – basic and diluted $ (4,688,476) $ (5,062,242) $ (14,354,366) $ (18,320,845) Weighted average common shares outstanding – basic and diluted 34,585,543 22,080,673 30,082,478 21,161,532 Net loss per common share – basic and diluted $ (0.14) $ (0.23) $ (0.48) $ (0.87)

3. Stockholders' Equity (Tables

3. Stockholders' Equity (Tables)	9 Months Ended
	Sep. 30, 2015
Summary of Preferred Stock and Warrants	As of September 30, 2015 As of December 31, 2014 Preferred Shares Outstanding Liquidation Preference (Per Share) Total Liquidation Preference Preferred Shares Outstanding Liquidation Preference (Per Share) Total Liquidation Preference Series B - $ - $ - 454,546 $ 0.001 $ 455 Series C-2 150,000 10.000 1,500,000 150,000 10.000 1,500,000 Series C-3 136,500 10.000 1,365,000 179,000 10.000 1,790,000 Series D 73,962 21.000 1,553,202 73,962 21.000 1,553,202 Series E 89,623 49.200 4,409,452 92,440 49.200 4,548,048 Total 450,085 $ 8,827,654 949,948 $ 9,391,705
Summary of Option Activity under Plan and Related Information	Shares Weighted Average Outstanding at beginning of period 3,664,500 $ 1.25 Exercised (499,955) $ 0.99 Forfeited (115,000) $ 2.08 Expired - $ - Granted 640,000 $ 4.60 Outstanding at end of period 3,689,545 $ 1.84 Options exercisable 3,151,712 $ 1.46 Weighted average remaining contractual life of stock options outstanding (years) 7.8 Weighted average remaining contractual life of stock options exercisable (years) 7.6 Weighted average vesting period over which total compensation expense related to non-vested options not yet recognized (years) 0.7 Aggregate intrinsic value of stock options exercised $ 3,260,728 Aggregate intrinsic value of stock options outstanding $ 2,325,974 Compensation expense related to non-vested options not yet recognized $ 956,462
Summary of Warrant Activity	Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life Outstanding at beginning of period 11,520,762 $ 1.99 2.57 Granted 284,174 $ 6.99 4.93 Expired (203,374) $ 3.44 - Exercised (7,179,374) $ 2.27 - Outstanding at end of period 4,422,188 $ 1.80 2.50
Stock options
Fair value assumptions for Black Sholes	In August 2015, the Company entered into a Release of Claims and Severance Modification Agreement with Randy Milby (See Note 5), the Company’s CEO, due to Mr. Milby’s anticipated termination of employment. As a result, the Company recorded a total of $507,341 compensation expense for the incremental value of an aggregate of 762,500 options during the nine months ended September 30, 2015 using the Black-Scholes option pricing model with the following assumptions: Expected term (years) 0.25 – 5 Volatility 94% - 97% Dividend yield 0.0% Risk-free interest rate 0.05% - 1.61% During the three and nine months ended September 30, 2015 total compensation expense was $921,153 and $2,908,855(including $507,341 expense recorded for the modification of Mr. Milby’s stock options), respectively and $166,439 and $1,942,192 for the three and nine months ended September 30, 2014, respectively. The fair value of the grants at grant dates is determined using the Black-Scholes option pricing model with the following assumptions for the nine months ended September 30, 2015: Expected term (years) 5 – 10 Volatility 93% - 94% Dividend yield 0.0% Risk-free interest rate 1.47% - 2.26% Weighted-average fair value of options granted during the period $ 3.46
Warrants
Fair value assumptions for Black Sholes	In March 2015, the Company issued two warrants exercisable for an aggregate of up to 283,400 common shares with an exercise price of $7.00 per share and a term of five years as a result of entering into a backstop agreement with Manchester Securities Corp. (“Manchester”) (See Note 4). Additionally, the expiration date of March 24, 2015 of warrants to purchase 390,720 shares of common stock issued to Manchester in connection with the Company’s initial public offering (“IPO”) was extended by one year to March 24, 2016. The Company recorded non-cash general and administrative expense of $1,583,252 for these warrants using the Black-Scholes option pricing model with the following assumptions: Expected term (years) 1 - 5 Volatility 75.81% - 104.08% Dividend yield 0.0% Risk-free interest rate 0.01% - 1.61% During the nine months ended September 30, 2015, the Company issued 774 warrants upon the exercise of a unit warrant related to the IPO. These warrants were subsequently exercised resulting in the issuance of 774 shares of common stock and gross proceeds of $2,661 to the Company. During the nine months ended September 30, 2015, the Company extended the expiration date for an aggregate of 38,400 warrants with an exercise price of $3.4375. The Company accounted for this transaction as a modification of warrants and recorded additional paid in capital and non-cash general and administrative expense in the amount of $112,982. The warrants were valued using the Black-Scholes option pricing model with the following assumptions: Expected term (days) 5 Volatility 88.17% Dividend yield 0.0% Risk-free interest rate .003%

5. Commitments and Contingenc16

5. Commitments and Contingencies (Tables)	9 Months Ended
	Sep. 30, 2015
Commitments and Contingencies Disclosure [Abstract]
Schedule of Future Minimum Rental Payments for Operating Leases	2015 $ 16,864 2016 66,236 2017 60,784 2018 15,000 Total $ 158,884

2. Summary of Significant Acc17

2. Summary of Significant Accounting Policies (Details) - USD ($)	Sep. 30, 2015	Dec. 31, 2014
Summary Of Significant Accounting Policies Details
Raw materials	$ 245,358	$ 293,976
Work in process	542,812	341,807
Finished goods	85,978	2,246
Inventory reserve	(175,000)	(175,000)
Total	$ 699,148	$ 463,029

2. Summary of Significant Acc18

2. Summary of Significant Accounting Policies (Details 1) - USD ($)	Sep. 30, 2015	Dec. 31, 2014
Accounting Policies [Abstract]
Professional and consulting fees	$ 318,721	$ 225,726
Accrued payroll and payroll taxes	477,726	13,393
Clinical trial and manufacturing development	366,459	0
Market research	108,320	137,345
Monitoring program fees	56,432	82,861
Statutory taxes	69,736	34,548
Other	52,763	27,652
Total	$ 1,450,157	$ 521,525

2. Summary of Significant Acc19

2. Summary of Significant Accounting Policies (Details 2) - shares	9 Months Ended
	Sep. 30, 2015	Sep. 30, 2014
Antidilutive Shares	14,415,732	22,519,877
Series B non-voting convertible preferred stock
Antidilutive Shares	0	454,546
Series C non-voting convertible preferred stock
Antidilutive Shares	2,865,000	3,340,000
Series D non-voting convertible preferred stock
Antidilutive Shares	1,479,240	1,479,240
Series E non-voting convertible preferred stock
Antidilutive Shares	1,959,759	2,021,358
Warrants
Antidilutive Shares	4,422,188	11,571,233
Shares underlying outstanding stock options
Antidilutive Shares	3,689,545	3,653,500

2. Summary of Significant Acc20

2. Summary of Significant Accounting Policies (Details 3) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2015	Sep. 30, 2014	Sep. 30, 2015	Sep. 30, 2014
Summary Of Significant Accounting Policies Details 3
Net Loss	$ (4,688,476)	$ (5,035,117)	$ (14,321,245)	$ (18,239,118)
Less: Dividends on participating securities	0	(27,125)	(33,121)	(81,727)
Net loss available to common shareholders - basic and diluted	$ (4,688,476)	$ (5,062,242)	$ (14,354,366)	$ (18,320,845)
Weighted average common shares outstanding - basic and diluted	34,585,543	22,080,673	30,082,478	21,161,532
Net loss per common share - basic and diluted	$ (0.14)	$ (0.23)	$ (0.48)	$ (0.87)

2. Summary of Significant Acc21

2. Summary of Significant Accounting Policies (Details Narrative) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2015	Sep. 30, 2014	Sep. 30, 2015	Sep. 30, 2014	Dec. 31, 2014
Accumulated deficit	$ (90,525,311)		$ (90,525,311)		$ (76,204,066)
Operating Income (loss)	4,712,560	$ 1,863,536	14,344,075	$ 6,687,806
Revenues	35,947	52,441	187,184	104,373
Total assets	39,306,582		39,306,582		5,097,762
Net property and equipment	41,075		41,075		$ 41,458
Europe
Revenues		$ 50,970		$ 102,902
Middle East and Europe
Revenues	33,741		180,566
United States [Member]
Total assets	38,257,032		38,257,032
Net property and equipment	$ 11,754		$ 11,754

3. Stockholders' Equity (Detail

3. Stockholders' Equity (Details) - USD ($)	Sep. 30, 2015	Dec. 31, 2014
Preferred Shares Outstanding	450,085	949,948
Total liquidation preference	$ 8,827,654	$ 9,391,705
Series B
Preferred Shares Outstanding	0	454,546
Liquidation Preference (Per Share)	$ 0	$ 0.001
Total liquidation preference	$ 0	$ 455
Series C-2
Preferred Shares Outstanding	150,000	150,000
Liquidation Preference (Per Share)	$ 10	$ 10
Total liquidation preference	$ 1,500,000	$ 1,500,000
Series C-3
Preferred Shares Outstanding	136,500	179,000
Liquidation Preference (Per Share)	$ 10	$ 10
Total liquidation preference	$ 1,365,000	$ 1,790,000
Series D non-voting convertible preferred stock
Preferred Shares Outstanding	73,962	73,962
Liquidation Preference (Per Share)	$ 21	$ 21
Total liquidation preference	$ 1,553,202	$ 1,533,202
Series E non-voting convertible preferred stock
Preferred Shares Outstanding	89,623	92,440
Liquidation Preference (Per Share)	$ 49.200	$ 49.200
Total liquidation preference	$ 4,409,452	$ 4,548,048

3. Stockholders' Equity (Deta23

3. Stockholders' Equity (Details 1)	9 Months Ended
	Sep. 30, 2015$ / shares
Stock Option Modification
Expected Term, minimum	3 months
Expected Term, maximum	5 years
Volatility, minimum	94.00%
Volatility, maximum	97.00%
Dividend yield	0.00%
Risk-free interest rate, minimum	0.05%
Risk-free interest rate, maximum	1.61%
Stock options
Expected Term, minimum	5 years
Expected Term, maximum	10 years
Volatility, minimum	93.00%
Volatility, maximum	94.00%
Dividend yield	0.00%
Risk-free interest rate, minimum	1.47%
Risk-free interest rate, maximum	2.26%
Weighted-average fair value of options granted during the period	$ 3.46

3. Stockholders' Equity (Deta24

3. Stockholders' Equity (Details 2) - Stock options	9 Months Ended
	Sep. 30, 2015USD ($)$ / sharesshares
Number of Options
Outstanding at beginning of period | shares	3,664,500
Number of Options Exercised | shares	(499,955)
Number of Options Forfeited | shares	(115,000)
Number of Options Expired | shares	0
Number of Options Granted | shares	640,000
Outstanding at end of period | shares	3,689,545
Options exercisable | shares	3,151,712
Weighted Average Exercise Price
Weighted Average Exercise Price Outstanding, Beginning	$ 1.25
Weighted Average Exercise Price Exercised	0.99
Weighted Average Exercise Price Forfeited	2.08
Weighted Average Exercise Price Expired	0
Weighted Average Exercise Price Granted	4.60
Weighted Average Exercise Price Outstanding, Ending	1.84
Weighted Average Exercise Price Exercisable	1.46
Weighted-average fair value of options granted during the period	$ 3.46
Weighted Average Remaining Contractual Life (in years)
Weighted Average Remaining Contractual Life (in years) Outstanding, Ending	7 years 9 months 18 days
Weighted Average Remaining Contractual Life (in years) Exercisable	7 years 7 months 6 days
Weighted average vesting period over which total compensation expense related to non-vested options not yet recognized (years)	8 months 12 days
Aggregate Intrinsic Value
Aggregate Intrinsic Value Exercised | $	$ 3,260,728
Aggregate intrinsic value of stock options outstanding | $	2,325,974
Compensation expense related to non-vested options not yet recognized | $	$ 956,462

3. Stockholders' Equity (Deta25

3. Stockholders' Equity (Details 3)	9 Months Ended
	Sep. 30, 2015
Manchester Warrants
Expected Term, minimum	1 year
Expected Term, maximum	5 years
Volatility, minimum	75.81%
Volatility, maximum	104.08%
Dividend yield	0.00%
Risk-free interest rate, minimum	0.01%
Risk-free interest rate, maximum	1.61%
Warrants
Expected Term	5 days
Volatility	88.17%
Dividend yield	0.00%
Risk-free interest rate	0.003%

3. Stockholders' Equity (Deta26

3. Stockholders' Equity (Details 4) - Warrants	9 Months Ended
	Sep. 30, 2015$ / sharesshares
Outstanding at beginning of period	11,520,762
Number of Warrants Granted	284,174
Number of Warrants Expired	(203,374)
Number of Warrants Exercised	(7,179,374)
Outstanding at end of period	4,422,188
Weighted Average Exercise Price Outstanding, Beginning | $ / shares	$ 1.99
Weighted Average Exercise Price Granted | $ / shares	6.99
Weighted Average Exercise Price Expired | $ / shares	3.44
Weighted Average Exercise Price Exercised | $ / shares	2.27
Weighted Average Exercise Price Outstanding, Ending | $ / shares	$ 1.80
Weighted Average Remaining Contractual Life (in years) Outstanding, Beginning	2 years 6 months 25 days
Weighted Average Remaining Contractual Life (in years) warrants granted	4 years 11 months 5 days
Weighted Average Remaining Contractual Life (in years) Outstanding, Ending	2 years 6 months

5. Commitments and Contingenc27

5. Commitments and Contingencies (Details)	Sep. 30, 2015USD ($)
Commitments And Contingencies Details
2,015	$ 16,864
2,016	66,236
2,017	60,784
2,018	15,000
Total	$ 158,884