CorMedix (CRMD) 10-Q 9 Nov 17 2017 Q3 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	9 Months Ended
	Sep. 30, 2017	Nov. 07, 2017
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, 2017
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	Accelerated Filer
Entity Common Stock, Shares Outstanding		67,019,794
Document Fiscal Period Focus	Q3
Document Fiscal Year Focus	2,017

CONDENSED CONSOLIDATED BALANCE

CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($)	Sep. 30, 2017	Dec. 31, 2016
Current assets
Cash and cash equivalents	$ 5,212,579	$ 8,064,490
Restricted cash	171,553	171,553
Short-term investments	6,796,313	12,100,920
Trade receivables	89,449	12,014
Inventories, net	299,485	166,733
Prepaid research and development expenses	890,704	943,924
Other prepaid expenses and current assets	392,585	372,057
Total current assets	13,852,668	21,831,691
Property and equipment, net	71,036	69,695
Security deposit	5,000	5,000
TOTAL ASSETS	13,928,704	21,906,386
Current liabilities
Accounts payable	1,408,206	1,645,298
Accrued expenses	2,757,564	2,342,352
Deferred revenue	86,642	104,210
Total current liabilities	4,252,412	4,091,860
TOTAL LIABILITIES	4,252,412	4,091,860
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS' EQUITY
Preferred stock - $0.001 par value: 2,000,000 shares authorized; 417,585 and 450,085 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively	418	450
Common stock - $0.001 par value: 160,000,000 and 80,000,000 shares authorized at September 30, 2017 and December 31, 2016, respectively; 61,978,609 and 40,432,339 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively	61,979	40,433
Accumulated other comprehensive income	94,711	81,186
Additional paid-in capital	151,383,530	136,857,409
Accumulated deficit	(141,864,346)	(119,164,952)
TOTAL STOCKHOLDERS' EQUITY	9,676,292	17,814,526
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$ 13,928,704	$ 21,906,386

CONDENSED CONSOLIDATED BALANCE3

CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares	Sep. 30, 2017	Dec. 31, 2016
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	417,585	450,085
Preferred stock, shares outstanding	417,585	450,085
Common stock, par value	$ 0.001	$ 0.001
Common stock, shares authorized	160,000,000	80,000,000
Common stock, shares issued	61,978,609	40,432,339
Common stock, shares outstanding	61,978,609	40,432,339

CONDENSED CONSOLIDATED STATEMEN

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE GAIN (LOSS) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2017	Sep. 30, 2016	Sep. 30, 2017	Sep. 30, 2016
Revenue
Net sales	$ 61,075	$ 44,451	$ 236,801	$ 102,390
Cost of sales	(66,652)	(43,922)	(178,276)	(281,342)
Gross profit (loss)	(5,577)	529	58,525	(178,952)
Operating Expenses
Research and development	(6,014,260)	(6,840,413)	(16,028,151)	(11,702,965)
Selling, general and administrative	(1,992,134)	(2,318,091)	(6,683,953)	(6,449,608)
Total Operating Expenses	(8,006,394)	(9,158,504)	(22,712,104)	(18,152,573)
Loss From Operations	(8,011,971)	(9,157,975)	(22,653,579)	(18,331,525)
Other Income (Expense)
Interest income	37,156	32,866	89,164	93,928
Foreign exchange transaction loss	(4,692)	(1,091)	(11,515)	(5,622)
Change in fair value of derivative liability	(1,974,019)	0	(120,654)	0
Interest expense	(2,810)	0	(2,810)	(992)
Total Other Income (Expense)	(1,944,365)	31,775	(45,815)	87,314
Net Loss	(9,956,336)	(9,126,200)	(22,699,394)	(18,244,211)
Other Comprehensive Income (Loss):
Unrealized gain (loss) from investments	2,600	(6,765)	13,013	17,233
Foreign currency translation gain (loss)	(4,573)	(82)	512	3,935
Total Other Comprehensive Income (Loss)	(1,973)	(6,847)	13,525	21,168
Comprehensive Loss	$ (9,958,309)	$ (9,133,047)	$ (22,685,869)	$ (18,223,043)
Net Loss Per Common Share - Basic and Diluted	$ (0.17)	$ (0.23)	$ (0.44)	$ (0.49)
Weighted Average Common Shares Outstanding - Basic and Diluted	60,290,988	39,053,956	51,238,399	37,156,790

Statement - CONDENSED CONSOLIDA

Statement - CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS' EQUITY (Unaudited) - 9 months ended Sep. 30, 2017 - USD ($)	Common Stock	Non-Voting Preferred Stock - Series B, Series C-2, Series C-3, Series D and Series E	Accumulated Other Comprehensive Income	Additional Paid-In Capital	Accumulated Deficit	Total
Beginning balance, Shares at Dec. 31, 2016	40,432,339	450,085
Beginning balance, Amount at Dec. 31, 2016	$ 40,433	$ 450	$ 81,186	$ 136,857,409	$ (119,164,952)	$ 17,814,526
Stock issued in connection with ATM sale of common stock, net, Shares	198,360
Stock issued in connection with ATM sale of common stock, net, Amount	$ 199			347,163		347,362
Conversion of Series C-3 non-voting preferred stock to common stock, Shares	325,000	(32,500)
Conversion of Series C-3 non-voting preferred stock to common stock, Amount	$ 325	$ (32)		(293)		0
Stock issued in connection with stock options exercised, Shares	10,000
Stock issued in connection with stock options exercised, Amount	$ 10			6,790		6,800
Stock issued in connection with public offering, Shares	18,619,301
Stock issued in connection with public offering, Amount	$ 18,619			12,779,706		12,798,325
Stock issued in connection with warrants cashless exercise, Shares	970
Stock issued in connection with warrants cashless exercise, Amount	$ 1			(1)		0
Warrants issued in connection with public offering				(3,733,542)		(3,733,542)
Conversion of Series A warrants to common stock, Shares	2,387,500
Conversion of Series A warrants to common stock, Amount	$ 2,387			(2,387)		0
Stock issued for payment of deferred fees, Shares	4,869
Stock issued for payment of deferred fees, Amount	$ 5			10,213		10,218
Reclassification of derivative liability to equity				3,854,195		3,854,195
Stock-based compensation				1,264,277		1,264,277
Other comprehensive income			13,525			13,525
Net loss					(22,699,394)	(22,699,394)
Ending balance, Shares at Sep. 30, 2017	61,978,609	417,585
Ending balance, Amount at Sep. 30, 2017	$ 61,979	$ 418	$ 94,711	$ 151,383,530	$ (141,864,346)	$ 9,676,292

CONDENSED CONSOLIDATED STATEME6

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($)	9 Months Ended
	Sep. 30, 2017	Sep. 30, 2016
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$ (22,699,394)	$ (18,244,211)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation	1,264,277	920,864
Change in fair value of derivative liability	120,654	0
Inventory reserve increase (decrease)	(200,000)	166,000
Depreciation	26,694	16,923
Changes in operating assets and liabilities:
(Increase) decrease in trade receivables	(71,611)	301,169
Decrease in inventory	67,248	92,361
Increase in prepaid expenses and other current assets	(84,004)	(981,963)
Increase (decrease) in accounts payable	(241,509)	47,233
Increase in accrued expenses	533,342	1,921,043
Decrease in deferred revenue	(25,716)	(6,786)
Net cash used in operating activities	(21,310,019)	(15,767,367)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of short-term investments	(13,074,169)	0
Sale of short-term investments	18,391,789	6,758,906
Purchase of equipment	(26,632)	(55,107)
Net cash provided by investing activities	5,290,988	6,703,799
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from sale of common stock from at-the-market program	347,362	6,220,556
Proceeds from the public offering of common stock and warrants	12,798,325	0
Proceeds from exercise of stock options	6,800	849,501
Net cash provided by financing activities	13,152,487	7,070,057
Foreign exchange effect on cash	14,633	3,040
Net Decrease In Cash	(2,851,911)	(1,990,471)
Cash - Beginning of Period	8,064,490	11,817,418
Cash - End of Period	5,212,579	9,826,947
Cash paid for interest	2,810	992
Supplemental Disclosure of Non-Cash Financing Activities:
Conversion of preferred stock to common stock	32	0
Unrealized gain from investments	13,013	17,233
Reclassification of warrant liability to equity	3,854,195	0
Issuance of common stock for payment of deferred fees	$ 10,218	$ 0

1. Organization, Business and B

1. Organization, Business and Basis of Presentation	9 Months Ended
	Sep. 30, 2017
Organization Business And Basis Of Presentation
Organization, Business and Basis of Presentation	Organization and Business CorMedix Inc. (“CorMedix” or the “Company”), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases, was incorporated in the State of Delaware on July 28, 2006. In 2013, the Company formed a wholly-owned subsidiary, CorMedix Europe GmbH, based in Fulda, Germany. The Company’s primary focus is to develop its lead product candidate, CRMD003 (also known as Neutrolin®), for potential commercialization in the United States (“U.S.”) and other key markets. The Company has in-licensed the worldwide rights to develop and commercialize Neutrolin, which is a novel anti-infective solution (a formulation of taurolidine, citrate and heparin 1000 u/ml) under development for the reduction and prevention of catheter-related infections and thrombosis in patients requiring central venous catheters in clinical settings such as dialysis, critical/intensive care, and oncology. The Company launched its first Phase 3 clinical trial in hemodialysis patients with catheters in the U.S. in December 2015. The clinical trial, named Catheter Lock Solution Investigational Trial or LOCK-IT-100, is a prospective, multicenter, randomized, double-blind, active control trial which aims to demonstrate the efficacy and safety of Neutrolin in preventing catheter-related bloodstream infections, or CRBSI, in subjects receiving hemodialysis therapy as treatment for end stage renal disease (see Note 5 – Clinical and Regulatory). Two pivotal clinical trials to demonstrate safety and effectiveness of Neutrolin are required by the U.S. Food and Drug Administration (“FDA”) to secure marketing approval in the U.S. Based on its experience and recent feedback from the FDA on the LOCK-IT-100 trial, the Company is assessing the structure of its planned second Phase 3 clinical trial to seek efficiencies and improvements in design and execution of that trial. The Company received CE Mark approval for Neutrolin in 2013 and commercially launched 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. Neutrolin is registered and is being sold in certain European Union and Middle Eastern countries. The completion of the Company’s ongoing LOCK-IT-100 clinical trial and the execution of the planned second Phase 3 clinical trial are dependent on the Company’s ability to raise sufficient additional funds through various potential sources, such as equity, debt financings, and/or strategic relationships. The Company can provide no assurances that financing or strategic relationships will be available on acceptable terms, or at all, to complete its clinical development program for Neutrolin. 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, the 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, 2017 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 which are included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 16, 2017. The accompanying condensed balance sheet as of December 31, 2016 has been derived from the audited financial statements included in such Form 10-K.

2. Summary of Significant Accou

2. Summary of Significant Accounting Policies	9 Months Ended
	Sep. 30, 2017
Accounting Policies [Abstract]
Summary of Significant Accounting Policies	Liquidity, Going Concern 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 Company’s ability to raise capital to support its operations; the cost, timing and results of clinical trials; 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, the Company’s products; and the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products. The financial statements have been prepared in conformity with GAAP which contemplate continuation of the Company as a going concern. To date, the Company’s commercial operations have not generated sufficient revenues to enable profitability. As of September 30, 2017, the Company had an accumulated deficit of $141.9 million, and had incurred net losses of $10.0 million and $22.7 million for the three and nine months then ended. Based on the Company’s current development plans for Neutrolin in both the U.S. and foreign markets (including the ongoing hemodialysis Phase 3 clinical trial in the U.S.) and its other operating requirements, the Company’s existing cash and short-term investments at September 30, 2017 are expected to fund its operations through the first quarter of 2018, after taking into consideration the net proceeds received in October 2017 and the anticipated net proceeds from the securities purchase and backstop agreements (see Note 7 - Subsequent Events). These factors raise substantial doubt regarding the Company’s ability to continue as a going concern. At September 30, 2017, approximately $3.7 million remained available for sale under an April 2015 $40.0 million At-the-Market Issuance Sales Agreement (the “Current ATM program”) with MLV & Co. LLC (“MLV”), a subsidiary of B. Riley Financial, Inc. At September 30, 2017, the Company also had approximately $46.0 million available under its current shelf registration for the issuance of equity, debt or equity-linked securities unrelated to the Current ATM program. On May 3, 2017, the Company closed an equity financing under its current shelf registration statement, which raised net proceeds of approximately $12.8 million (see Note 3). The Company’s continued operations including completion of its ongoing LOCK-IT-100 clinical trial as well as the other Phase 3 clinical program requirements for Neutrolin in the U.S., will depend on its ability to raise additional capital. Management is actively pursuing financing plans but can provide no assurances that such financing will be available on acceptable terms, or at all. Without this funding, the Company will be required to delay, scale back or eliminate its ongoing LOCK-IT-100 clinical trial as well as work on the other Phase 3 clinical program requirements for Neutrolin in CRBSI which would likely have a material adverse effect on the Company. The financial statements do not include any adjustments relating to the recoverability and classification of asset carrying amounts or the amount and classification of liabilities that might result should the Company be unable to continue as a going concern. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make 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, its wholly owned subsidiary. All significant intercompany accounts and transactions have been eliminated in consolidation. Financial Instruments Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents and short-term investments. The Company maintains its cash and cash equivalents in bank deposit and other interest bearing accounts, the balances of which, at times, may exceed federally insured limits. The appropriate classification of marketable securities is determined at the time of purchase and reevaluated as of each balance sheet date. Investments in marketable debt and equity securities classified as available-for-sale are reported at fair value. Fair value is 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 other income (expense). 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, 2017 or December 31, 2016. 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, 2017 and December 31, 2016, all of the Company’s investments had contractual maturities of less than one year. The following table summarizes the amortized cost, unrealized gains and losses and the fair value at September 30, 2017 and December 31, 2016: September 30, 2017 Amortized Cost Gross Unrealized Losses Gross Unrealized Gains Fair Value Money Market Funds included in Cash Equivalents $ 2,605,588 $ - $ - $ 2,605,588 U.S. Government Securities 998,940 - 80 999,020 Corporate Securities 4,999,877 (479 ) 200 4,999,598 Commercial Paper 797,695 - - 797,695 Subtotal 6,796,512 (479 ) 280 6,796,313 Total September 30, 2017 $ 9,402,100 $ (479 ) $ 280 $ 9,401,901 December 31, 2016 Money Market Funds included in Cash Equivalents $ 95,949 $ - $ - $ 95,949 Corporate Securities 10,619,583 (13,212 ) - 10,606,371 Commercial Paper 1,494,549 - - 1,494,549 Subtotal 12,114,132 (13,212 ) - 12,100,920 Total December 31, 2016 $ 12,210,081 $ (13,212 ) $ - $ 12,196,869 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, accrued expenses and warrant derivatives (see Note 3 – Stockholders’ Equity, Warrants). 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 in 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, 2017 and December 31, 2016: September 30, 2017 Carrying Value Level 1 Level 2 Level 3 Money Market Funds $ 2,605,588 $ 2,605,588 $ - $ - U.S. Government Securities 999,020 - 999,020 - Corporate Securities 4,999,598 - 4,999,598 - Commercial Paper 797,695 - 797,695 - Subtotal 6,796,313 - 6,796,313 - Total September 30, 2017 $ 9,401,901 $ 2,605,588 $ 6,796,313 - December 31, 2016 Money Market Funds $ 95,949 $ 95,949 $ - - Corporate Securities 10,606,371 - 10,606,371 - Commercial Paper 1,494,549 - 1,494,549 - Subtotal 12,100,920 - 12,100,920 - Total December 31, 2016 $ 12,196,869 $ 95,949 $ 12,100,920 $ - Foreign Currency Translation and Transactions The 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 period in which the income and expenses were recognized. Translation gains and losses are included in other comprehensive loss. The Company has intercompany loans between the parent company based in New Jersey and its German subsidiary. The intercompany loans outstanding are not expected to be repaid in the foreseeable future and unrealized foreign exchange movements related to long-term intercompany loans are recognized in other comprehensive income. 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. Restricted Cash As of September 30, 2017 and December 31, 2016, the Company’s restricted cash is in connection with the patent and utility model infringement proceedings against TauroPharm (see Note 5). 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 furthermore had to provide a deposit in the amount of $40,000 in connection with the unfair competition proceedings in Cologne. Prepaid Research and Development Prepaid research and development expenses consist of payments made in advance to vendors relating to service contracts for clinical trial development and other research and development. 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 net realizable value 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, 2017 December 31, 2016 Raw materials $ 290,970 $ 79,900 Work in process 158,997 463,897 Finished goods 79,518 52,936 Inventory reserve (230,000 ) (430,000 ) Total $ 299,485 $ 166,733 Accrued Expenses Accrued expenses consist of the following: September 30, 2017 December 31, 2016 Professional and consulting fees $ 235,435 $ 335,198 Accrued payroll and payroll taxes 801,774 737,607 Clinical trial and manufacturing development 1,433,827 875,500 Product development 80,001 374,839 Market research 116,466 - Other 90,061 19,208 Total $ 2,757,564 $ 2,342,352 Derivative Liability The Company does not use derivative instruments to hedge exposures to cash flow, market or foreign currency risks; however, the Company has certain financial instruments that qualify as derivatives and are classified as liabilities on the balance sheet. The Company evaluates all its financial instruments to determine if those instruments or any potential embedded components of those instruments qualify as derivatives that need to be separately accounted for in accordance with FASB ASC 815, “Derivatives and Hedging” The Company accounts for stock warrants as either equity instruments or derivative liabilities depending on the specific terms of the warrant agreement. Stock warrants are classified as derivative liabilities if they can be cash settled or if there are insufficient authorized and unissued shares available to settle the contract after considering all other commitments that may require the issuance of stock during the maximum period the warrant could remain outstanding. Liability classified warrants are adjusted to their estimated fair values at each reporting period, with any decrease or increase in the estimated fair value being recorded in other income (expense). In May 2017, the Company issued warrants that were liability-classified because there were insufficient shares of common stock available to settle the contracts. The carrying values of those warrants were adjusted to their estimated fair values at June 30, 2017 and again during the third quarter when sufficient additional common shares were authorized to cause the warrants to be reclassified as equity. The fair values on the issuance date and subsequent re-measurement dates were estimated using a probability-weighted option pricing model, requiring assumptions to be developed under different scenarios for the expected term, expected volatility, expected dividend yield and the risk-free interest rate. The Company estimated the expected term of the warrants based on the remaining contractual term. Expected volatility was calculated based on implied volatility of the stock price. The expected dividend yield is assumed to be zero in all scenarios because the Company have never, and have no plans at this time, to pay any dividends. To determine the risk free interest rate, the Company used the U.S. Treasury yield curve in effect at the time of the measurement with a term consistent with the remaining expected term of the warrant. Revenue Recognition Revenue is recognized from product sales when the following four revenue recognition criteria are met: persuasive evidence of an arrangement exists, delivery has occurred, the selling price is fixed or determinable, and collectability is reasonably assured. The Company recognizes revenue once the four revenue recognition criteria are met in accordance with the terms of its various distribution agreements. Deferred Revenue In October 2015, the Company shipped product with less than 75% of its remaining shelf life to a customer and issued a guarantee that the specific product shipped would be replaced by the Company if the customer was not able to sell the product before it expired. Due to limited sales experience with the customer, the Company was unable to estimate the amount of the warranty obligation that may be incurred as a result of this shipment. Therefore, the Company deferred the revenue and related cost of sales associated with this shipment as net within deferred revenue in the condensed consolidated balance sheet. During the three and nine months ended September 30, 2017, the Company recognized $35,700 and $101,600 of deferred revenue and $21,000 and $59,700 in related cost of sales resulting in the net revenue recognition amounts of $14,700 and $41,900, respectively. Also, during the three and nine months ended September 30, 2017, the Company had recorded an additional net deferred revenue of $0 and $24,000, respectively. Deferred revenue, net at September 30, 2017 and December 31, 2016 amounted to approximately $86,600 and $104,200, respectively. 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. 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. Nine Months Ended September 30, 2017 2016 Series C non-voting convertible preferred stock 2,540,000 2,865,000 Series D non-voting convertible preferred stock 1,479,240 1,479,240 Series E non-voting convertible preferred stock 1,959,759 1,959,759 Shares underlying outstanding warrants 23,189,284 4,006,468 Shares underlying restricted stock units 61,414 - Shares underlying outstanding stock options 4,946,429 4,637,255 Total 34,176,126 14,947,722 Shares underlying outstanding warrants include an aggregate of 29,046,110 warrants issued on an underwritten public offering which closed on May 3, 2017 (see Note 3) of which 9,549,999 warrants were exchanged for 2,387,500 shares of common stock during the quarter ended September 30, 2017. Stock-Based Compensation Share-based compensation cost is measured at grant date, based on the estimated fair value of the award using the Black-Scholes option pricing model for options with service or performance-based conditions and a Monte Carlo option pricing model for options with market conditions. Stock-based compensation is recognized as expense over the employee’s requisite service period on a straight-line basis. Effective October 1, 2016, the Company early adopted ASU 2016-09 to account for forfeitures as they occur. All share-based awards will be recognized on a straight-line method, assuming all awards granted will vest. Forfeitures of share-based awards will be recognized in the period in which the forfeitures occur. Prior to the adoption of ASU 2016-09, share-based compensation expense was recognized by applying the expected forfeiture rate during the vesting period to the fair value of the award. As a result of the adoption of ASU 2016-09, the Company’s condensed consolidated statement of operations and comprehensive loss and condensed consolidated statement of cash flows for the three and nine months ended September 30, 2016 were adjusted to reflect the impact. 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, “Compensation-Stock Compensation” “Equity-Based Payments to Non-Employees” Research and Development Research and development costs are charged to expense as incurred. Research and development includes fees associated with operational consultants, contract clinical research organizations, contract manufacturing organizations, clinical site fees, contract laboratory research organizations, contract central testing laboratories, licensing activities, and allocated executive, human resources and facilities expenses. The Company accrues for costs incurred as the services are being provided by monitoring the status of the trial and the invoices received from its external service providers. As actual costs become known, the Company adjusts its accruals in the period when actual costs become known. Costs related to the acquisition of technology rights and patents for which development work is still in process are charged to operations as incurred and considered a component of research and development expense. Recent Authoritative Pronouncements In May 2014, the FASB issued new guidance related to how an entity should recognize revenue. The guidance specifies that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods and services. In addition, the guidance expands the required disclosures related to revenue and cash flows from contracts with customers. In April 2016 and May 2016, the FASB issued updates in order to provide improvements and clarifications to the revenue recognition guidance. In certain customer arrangements, under current GAAP, the Company has deferred revenue for certain product sales a result of the ability for the customer to return the product under certain conditions. Under the new standard, the Company will be required to estimate expected revenue at the point of sale. The Company will adopt the new revenue recognition standard as of January 1, 2018 using the modified retrospective method. In July 2017, the FASB issued new guidance which changes the classification analysis of certain equity-linked financial instruments (or embedded features) with down round features and recharacterizes the indefinite deferral of certain provisions within the guidance for distinguishing liabilities from equity. The guidance is effective for the Company beginning in the first quarter of fiscal year 2019. Early adoption is permitted. The Company is evaluating the impact of adopting this guidance on its consolidated financial statements.

3. Stockholders' Equity

3. Stockholders' Equity	9 Months Ended
	Sep. 30, 2017
STOCKHOLDERS' EQUITY
Stockholders' Equity	Common Stock On May 3, 2017, the Company closed an underwritten public offering of 18,619,301 shares of its common stock, par value $0.001 per share, together with Series A warrants (“Series A Warrants”) to purchase up to an aggregate of 13,964,476 shares of its common stock and Series B warrants (“Series B Warrants”) to purchase up to an aggregate of 13,964,476 shares of its common stock. Series A Warrants have an exercise price of $0.75 per share of common stock and will expire thirteen months following the Exercisable Date (defined below). Series B Warrants have an exercise price of $1.05 per share of common stock and will expire five years following the Exercisable Date. The net proceeds from this public offering was approximately $12.8 million. The Company issued the underwriter warrants to purchase up to an aggregate of 1,117,158 shares of common stock, with an exercise price of $0.9375, which represents 125% of the public offering price per combined share and related warrants. The underwriter warrant will expire five years following the Exercisable Date. Other than the exercise price, the terms of the underwriter warrants are the same as the Series B Warrants. In May 2017, the Company did not have a sufficient number of authorized shares of common stock to cover the shares issuable upon exercise of the warrants issued in the May 2017 public offering and therefore classified the fair value of the warrants as a derivative liability at June 30, 2017. On August 8, 2017, the Company’s shareholders approved the amendment of the Company’s amended and restated Certificate of Incorporation (the “Charter Amendment”) increasing the shares of authorized capital stock from 82,000,000 shares to 162,000,000 shares and increasing the number of authorized shares of common stock from 80,000,000 to 160,000,000 shares. The fair value of these warrants was re-measured on August 10, 2017, the date the warrants became exercisable (the “Exercisable Date”), with the increase in value recorded as a loss in the statement of operations. The fair value of the warrants at August 10, 2017 was reclassified then from liability to equity. At September 30, 2017, approximately $3.7 million remained available for sale under the Current ATM Program. MLV is entitled to a commission of up to 3% of the gross proceeds from the sale of common stock sold under the Current ATM Program. The shares of common stock to be sold under the Current ATM Program are registered under an effective registration statement filed with the SEC. During the nine months ended September 30, 2017, the Company issued 198,630 shares of common stock under the Current ATM Program and realized net proceeds of approximately $347,000. During the nine months ended September 30, 2017, the Company issued 10,000 shares of its common stock upon exercise of stock options resulting in gross proceeds of $6,800 to the Company. During the nine months ended September 30, 2017, the Company issued an aggregate of 325,000 shares of its common stock upon conversion of an aggregate of 32,500 Series C-3 non-voting preferred stock. During the nine months ended September 30, 2017, the Company issued 970 shares of its common stock upon cashless exercise of 62,500 warrants. Stock Options During the nine months ended September 30, 2017, the Company granted ten-year qualified and non-qualified stock options covering an aggregate of 1,342,500 shares of the Company’s common stock under the 2013 Stock Incentive Plan. During the nine months ended September 30, 2017, and 2016, total compensation expense for stock options issued to employees, directors, officers and consultants was $1,202,260 and $920,864, respectively, and $388,616 and $192,685 for the three months ended September 30, 2017 and 2016, respectively. As of September 30, 2017, there was approximately $3,184,000 in total unrecognized compensation expense related to stock options granted, which expense will be recognized over an expected remaining weighted average period of 1.5 years. The fair value of the grants are determined using the Black-Scholes option pricing model with the following assumptions: Nine Months Ended September 30, 2017 2016 Expected Term 5 years 5 – 10 years Volatility 99.85% - 105.07% 96% - 98% Dividend yield 0.0% 0.0% Risk-free interest rate 1.77% - 1.99% 1.14% - 1.94% Weighted average fair value of options granted during the period $1.21 $ 1.76 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. Beginning January 1, 2017, 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. In 2016 the expected stock price volatility was calculated based on the historical volatility since the initial public offering weighted pre and post CE Mark approval in the European Union. 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. The following table summarizes the Company’s stock options activity and related information for the nine months ended September 30, 2017: Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Outstanding at beginning of period 4,609,755 $ 2.29 8.2 $ 581,823 Exercised (10,000 ) $ 0.68 13,200 Forfeited (433,116 ) $ 1.85 Expired/Canceled (562,710 ) $ 2.99 Granted 1,342,500 $ 1.57 Outstanding at end of period 4,946,429 $ 2.05 7.7 $ 0 Vested at end of period 2,152,520 $ 1.82 6.0 $ 0 The total intrinsic value of stock options exercised during the three and nine months ended September 30, 2017 was $0 and $13,200, respectively, and $486,550 and $1,466,589 for the three and nine months ended September 30, 2016, respectively. 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. Restricted Stock Units During the nine months ended September 30, 2017, the Company granted an aggregate of 107,931 restricted stock units (“RSUs”) to its officers and directors under its 2013 Stock Incentive Plan with a weighted average grant date fair value of $2.22 per share. These RSUs vest over various dates through December 31, 2018. During the three and nine months ended September 30, 2017, compensation expense recorded for these RSUs was $26,019 and $62,017, respectively. Unrecognized compensation expense as of September 30, 2017 was $73,387. The expected weighted average period for the expense to be recognized is 0.83 years. During the nine months ended September 30, 2017, 46,517 RSUs were forfeited. No RSUs were issued during the nine months ended September 30, 2016. Warrants As of September 30, 2017, there were 23,189,284 outstanding warrants, with a weighted average exercise price of $1.10 In the May 2017 public offering, the Company did not have sufficient number of authorized shares of common stock available to reserve the shares issuable upon the exercise of 29,046,110 outstanding warrants issued in the May 2017 public offering. Therefore, these warrants were classified as liabilities at June 30, 2017 and were re-measured on August 10, 2017, which was the Exercisable Date, with any increase or decrease in value recorded as a loss or gain in the income statement. The Company recorded a loss of $1,974,019 during the three months period ended September 30, 2017. Because as of August 9, 2017, the Company has enough authorized shares to cover issuance of these warrants, the derivative liability was reclassified to equity during the three months ended September 30, 2017 in the amount of $3,854,195. The fair value of the warrants was determined using a probability-weighted Black-Scholes option pricing under different scenarios regarding the expected probability and timing of sufficient additional shares being authorized to allow the warrants to become exercisable. The following assumptions were used to value the warrants at the grant date. Series A Series B Underwriter’s Expected Term 1.18 – 1.33 years 5.10 – 5.25 years 5.10 – 5.25 years Volatility 55% 55% 55% Dividend yield 0.0% 0.0% 0.0% Exercise Price $0.75 $1.05 $0.94 Risk-free interest rate 1.13% - 1.16% 1.86% - 1.88% 1.86% - 1.88% Weighted average fair value of warrants granted $0.08 $0.17 $0.18 Number of shares underlying warrants granted 13,964,476 13,964,476 1,117,158 As these warrants are liability-classified, they were revalued at August 10, 2017 using the following assumptions: Series A Series B Underwriter’s Expected Term 1.09 5.00 5.00 Volatility 96.95% 96.95% 96.95% Dividend yield 0.0% 0.0% 0.0% Exercise Price $ 0.75 $ 1.05 $ 0.94 Risk-free interest rate 1.22% 1.76% 1.76% Weighted average fair value of warrants $ 0.06 $ 0.20 $ 0.20

4. Related Party Transactions

4. Related Party Transactions	9 Months Ended
	Sep. 30, 2017
Related Party Transactions [Abstract]
Related Party Transactions	In September 2014, as part of the removal of anti-dilution, price reset and change of control provisions in various securities that had caused those securities to be classified as derivative liabilities, the Company entered into a Consent and Exchange Agreement with Manchester, pursuant to which Manchester had a right of 60% participation in equity financings undertaken by the Company prior to September 15, 2017. Pursuant to this right of participation, Manchester elected partial participation in the equity financing that the Company closed on May 3, 2017 and invested $2,000,000. On March 3, 2015, the Company entered into a backstop agreement with Manchester under which Manchester had agreed to lend the Company, at its request, up to $3,000,000. The Company did not access the loan and the agreement expired on April 30, 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 the backstop agreement. 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 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, 2017, two board members and one observer had been appointed to the board. The Company’s board of directors subsequently elected the observer to the board.

5. Commitments and Contingencie

5. Commitments and Contingencies	9 Months Ended
	Sep. 30, 2017
Commitments and Contingencies Disclosure [Abstract]
Commitments and Contingencies	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 European Patent Office (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 ND Partners’ 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 (the “German PTO”) 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-HEP100TM and TauroLock-HEP500TM products. A hearing before the same court was held on January 30, 2015 on the separate, but related, question of infringement of the Prosl European Patent by TauroPharm. 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 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 made a final decision on the underlying validity of the Prosl European Patent and the Utility Model. The opposition proceeding against the Prosl European Patent before the EPO is ongoing. The EPO held a hearing in the opposition proceeding on November 25, 2015. In its preliminary consideration of the matter, the EPO (and the German PTO) had regarded the patent as not inventive or novel due to publication of prior art. However, the EPO did not issue a decision at the end of the hearing but adjourned the matter due to the fact that the panel was of the view that Claus Herdeis, one of the managing directors of TauroPharm, has to be heard as a witness in a further hearing in order to close some gaps in the documentation presented by TauroPharm as regards the publication of the prior art. In October 2016, TauroPharm submitted a further writ to the EPO requesting a date for the hearing and bringing forward further arguments, in particular in view of the recent decision of the German PTO on the invalidity of the utility model. The EPO has scheduled a further oral hearing for November 22-23, 2017. 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 will be found to be valid by the EPO, there can be no assurance that the Company will prevail in this matter. The German PTO held a hearing in the validity proceedings relating to the Utility Model on June 29, 2016, at which the panel affirmed its preliminary finding that the Utility Model was invalid based upon prior publication of a reference to the benefits that may be associated with adding heparin to a taurolidine based solution. The decision has only a declaratory effect, as the Utility Model had expired in November 2015. Furthermore, it has no bearing on the ongoing consideration by the EPO of the validity and possible infringement of the Prosl European Patent. The Company filed an appeal against the ruling on September 7, 2016. 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 TauroLockTM, TauroLock-HEP100 and TauroLock-HEP500. The Company seeks a cease and desist order against TauroPharm from continuing to manufacture and sell any product containing taurolidine (the active pharmaceutical ingredient (“API”) of Neutrolin) and citric acid in addition to possible other components, damages for any sales in the past and the removal of all such products from the market. An initial hearing in the District Court of Cologne, Germany was held on November 19, 2015 to consider the Company’s claims. In this hearing, the presiding judge explained that the court needed more information with regard to several aspects of the case. As a consequence, the court issued an interim decision in the form of a court order outlining several issues of concern that relate primarily to the court's interest in clarifying the facts and reviewing any and all available documentation, in particular with regard to the question which specific know-how was provided to TauroPharm by whom and when. The Company's legal team has prepared the requested reply and produced the respective documentation. TauroPharm has also filed another writ within the same deadline and both parties have filed further writs at the end of April setting out their respective argumentation in more detail. A further oral hearing in this matter was held on November 15, 2016. In this hearing, the court heard arguments from CorMedix and TauroPharm concerning the allegations of unfair competition. The court made no rulings from the bench, and indicated that it is prepared to further examine the underlying facts of the Company's allegations. On March 7, 2017, the court issued another interim decision in the form of a court order outlining again several issues relating to the argumentation of both sides in the proceedings. In particular the court requested the Company to further specify its requests and to further substantiate in even more detail which know know-how was provided by Biolink to TauroPharm by whom and when. The court also raised the question whether the know-how provided at the time to TauroPharm could still be considered to be secret know-how or may have become public in the meantime. The court granted both sides the opportunity to reply to this court order and provide additional facts and evidence until May 15, 2017. Both parties have submitted further writs in this matter and the court has now scheduled a further hearing on May 8, 2018. The Company intends to continue to pursue this matter, and to provide additional supplemental documentary and other evidence as may be necessary to support its claims. 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 year ended December 31, 2015. The Company furthermore had to provide a deposit in the amount of $40,000 in connection with the unfair competition proceedings in Cologne. These amounts are shown as restricted cash on the condensed consolidated balance sheets. Commitments Manufacturing The Company entered into several service agreements with RC2 for the manufacture of clinical supplies to support its ongoing and planned Phase 3 clinical trials for an aggregate amount of $8.9 million at September 30, 2017. During the three and nine months ended September 30, 2017, the Company recognized research and development expense of approximately $523,000 and $1,416,000, respectively, related to these agreements and approximately $777,000 and $1,510,000 during the three and nine months ended September 30, 2016, 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 In December 2015, the Company entered into a Master Service Agreement and Work Orders (the “Master Service Agreement”) with PPD Development, LP (“PPD”) to help the Company conduct its Phase 3 multicenter, double-blind, randomized active control study (the “First Phase 3 Clinical Trial”) to demonstrate the safety and effectiveness of Neutrolin in preventing catheter-related bloodstream infections and blood clotting in subjects receiving hemodialysis therapy as treatment for end stage renal disease. In May 2017, the Company signed a contract modification with PPD to cover the extension of the estimated study timeline, incorporate several protocol amendments and take on several new tasks related to the enrollment sites. The total cost of the contract increased to $26.4 million from its original amount of $19.2 million. Given several recent changes to the study agreed with the FDA, an additional modification of the contract with PPD is being negotiated to cover the continuation of trial enrollment which is anticipated to continue into the second quarter of 2018, increased length of time in which patients are enrolled and additional activities related to the collection of retrospective data outside the treatment centers. The additional cost of this modification is budgeted for approximately $6.3 million. During the three and nine months ended September 30, 2017, the Company recognized $3,731,000 and $9,097,000 in research and development expense related to this agreement, respectively, and during the three and nine months ended September 30, 2016, the Company recognized approximately $1,801,000 and $3,804,000, respectively. The total expected future commitments under the existing May 2017 contract modification as of September 30, 2017 are estimated to be $12,400,000. In-Licensing In 2008, the Company entered into a License and Assignment Agreement (the “NDP License Agreement”) with ND Partners, LLP (“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 at the time 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. A total of 109,157 shares of common stock are held in escrow as of September 30, 2017 and December 31, 2016. The maximum aggregate amount of cash payments upon achievement of milestones is $3,000,000, with $2,500,000 remaining unearned at September 30, 2017. 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. There were no milestones achieved during the three and nine months ended September 30, 2017 and 2016. 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. Employment Agreements In January 2017, the Company entered into a three-year employment agreement with Robert Cook to serve as its Chief Financial Officer and with Judith Abrams to serve as its Chief Medical Officer, and in March 2017, the Company entered into an employment agreement with John Armstrong to serve as its Executive Vice President for Technical Operations. After the initial three-year term of each employment agreement, the agreement will automatically renew for additional successive one-year periods, unless either party notifies the other in writing at least 90 days before the expiration of the then current term that the agreement will not be renewed. In connection with their employment, the Company granted each of Mr. Cook and Dr. Abrams stock options to purchase 350,000 shares of common stock, with 185,000 of the options vesting in four equal annual installments on the first four anniversaries of the grant date. The remaining 165,000 options are split into three tranches, which become exercisable upon the achievement of specified performance milestones within designated respective time periods. In connection with his employment, the Company granted Mr. Armstrong stock options to purchase 100,000 shares of common stock, which vest upon the achievement of designated milestones. In each case, the executive must be an employee of or consultant to the Company on the applicable vesting date. Under the agreements, in the event the Company terminates the employment of Mr. Cook, Dr. Abrams or Mr. Armstrong other than for Cause (as defined in the agreements), death or disability, other than by notice of nonrenewal, or if any of them resigns for Good Reason (as defined in the agreements), he or she will receive his or her base salary and benefits for a period of nine months following the effective date of the termination of employment, and, in the case of Mr. Cook and Dr. Abrams, all unvested time-based stock options that are scheduled to vest on or before the next succeeding anniversary of the date of termination shall be accelerated and deemed to have vested as of the termination date. On August 24, 2017, Dr. Abrams resigned for personal reasons. The Company did not owe Dr. Abrams any severance obligations under her employment agreement. In connection with her resignation, on August 25, 2017, the Company entered into a consulting agreement with Dr. Abrams for a term of up to nine months. Pursuant to the consulting agreement, Dr. Abrams will receive a monthly payment of approximately $29,000, an upfront payment of approximately $17,000, vesting in full of an option to purchase 46,250 shares of Company common stock granted under her employment agreement, and, at her option, COBRA premiums for the period during which she receives monthly payments under the consulting agreement. The fair value of the options that fully vested was recorded as an expense by the Company in the amount of $35,000 and $60,000 for the three and nine months ended September 30, 2017, respectively. Other In September 2017, the Company entered into a sublease agreement for approximately 6,960 square feet of office space in Berkeley Heights, New Jersey, which sublease runs from September 15, 2017 to June 29, 2020. This sublease is rent-free to the Company. Effective October 1, 2017, the Company terminated its sublease for the 4,700 square feet of office space in Bedminster, New Jersey with no further lease obligation for the remainder of the sublease. Rent was $5,000 per month plus occupancy costs such as utilities, maintenance and taxes. Rent expense for the three and nine months ended September 30, 2017 was $7,000, and $43,000, respectively, and $17,000 and $51,000 for the three and nine months ended September 30, 2016, respectively. As of September 30, 2017, the Company has no remaining lease obligation.

6. Concentrations

6. Concentrations	9 Months Ended
	Sep. 30, 2017
Concentrations
Concentrations	At September 30, 2017, approximately 97% of net accounts receivable was due from two customers. During the three months ended September 30, 2017, the Company had revenue from two customers that each exceeded 10% (57% and 33%) of its total sales, and for the nine months ended September 30, 2017 three customers that each exceeded 10% of total sales (44%, 34% and 14%). For the three and nine months ended September 30, 2016, two customers exceeded 10% of its total sales (37% and 21%) and (30% and 20%), respectively.

7. Subsequent Events

7. Subsequent Events	9 Months Ended
	Sep. 30, 2017
Subsequent Events [Abstract]
Subsequent Events	During October 2017, the Company issued an aggregate of 5,041,185 shares of its common stock under its current ATM Program with an average sale price of $0.64 per share. The Company realized net proceeds of approximately $3.1 million. On November 9, 2017, the Company entered into a securities purchase agreement with an existing long-term institutional investor, whereby they will purchase a newly issued CorMedix Series F convertible preferred stock at $1,000 per share. Separately, the Company has entered into a backstop agreement with the same investor to purchase additional Series F convertible preferred Stock at $1,000 per share, at the Company’s sole discretion, beginning January 15, 2018, through March 31, 2018. Gross proceeds of the securities purchase agreement and the backstop agreement, if the backstop agreement is used in full, total an aggregate of $5.0 million. As consideration for the backstop agreement, the Company will issue warrants, exercisable for three years, to purchase shares of the Company’s common stock at a per share exercise price of $0.001. The number of shares issuable under the warrant will be determined by the closing price of the Company’s common stock on November 8, 2017, which was $0.5278. The investor may convert the preferred stock into common stock at its option at an effective price of $0.6334 per share, which represents a 20% premium to the closing price of the Company’s common stock on November 8, 2017. The preferred stock will be mandatorily convertible on April 2, 2018, subject to certain equity conditions, at the lower of $0.6334 and a 10% discount to the notional price at which an equity or equity linked transaction in an amount of $5.0 million or more is completed by March 31, 2018, or if no such transaction is completed, a 10% discount to the closing price of the stock on March 31, 2018. There will be no warrants to be issued under the securities purchase agreement.

2. Summary of Significant Acc14

2. Summary of Significant Accounting Policies (Policies)	9 Months Ended
	Sep. 30, 2017
Accounting Policies [Abstract]
Liquidity, Going Concern 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 Company’s ability to raise capital to support its operations; the cost, timing and results of clinical trials; 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, the Company’s products; and the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products. The financial statements have been prepared in conformity with GAAP which contemplate continuation of the Company as a going concern. To date, the Company’s commercial operations have not generated sufficient revenues to enable profitability. As of September 30, 2017, the Company had an accumulated deficit of $141.9 million, and had incurred net losses of $10.0 million and $22.7 million for the three and nine months then ended. Based on the Company’s current development plans for Neutrolin in both the U.S. and foreign markets (including the ongoing hemodialysis Phase 3 clinical trial in the U.S.) and its other operating requirements, the Company’s existing cash and short-term investments at September 30, 2017 are expected to fund its operations through the first quarter of 2018, after taking into consideration the net proceeds received in October 2017 and the anticipated net proceeds from the securities purchase and backstop agreements (see Note 7 - Subsequent Events). These factors raise substantial doubt regarding the Company’s ability to continue as a going concern. At September 30, 2017, approximately $3.7 million remained available for sale under an April 2015 $40.0 million At-the-Market Issuance Sales Agreement (the “Current ATM program”) with MLV & Co. LLC (“MLV”), a subsidiary of B. Riley Financial, Inc. At September 30, 2017, the Company also had approximately $46.0 million available under its current shelf registration for the issuance of equity, debt or equity-linked securities unrelated to the Current ATM program. On May 3, 2017, the Company closed an equity financing under its current shelf registration statement, which raised net proceeds of approximately $12.8 million (see Note 3). The Company’s continued operations including completion of its ongoing LOCK-IT-100 clinical trial as well as the other Phase 3 clinical program requirements for Neutrolin in the U.S., will depend on its ability to raise additional capital. Management is actively pursuing financing plans but can provide no assurances that such financing will be available on acceptable terms, or at all. Without this funding, the Company will be required to delay, scale back or eliminate its ongoing LOCK-IT-100 clinical trial as well as work on the other Phase 3 clinical program requirements for Neutrolin in CRBSI which would likely have a material adverse effect on the Company. The financial statements do not include any adjustments relating to the recoverability and classification of asset carrying amounts or the amount and classification of liabilities that might result should the Company be unable to continue as a going concern.
Use of Estimates	The preparation of financial statements in conformity with GAAP requires management to make 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, its wholly owned subsidiary. All significant intercompany accounts and transactions have been eliminated in consolidation.
Financial Instruments	Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents and short-term investments. The Company maintains its cash and cash equivalents in bank deposit and other interest bearing accounts, the balances of which, at times, may exceed federally insured limits. The appropriate classification of marketable securities is determined at the time of purchase and reevaluated as of each balance sheet date. Investments in marketable debt and equity securities classified as available-for-sale are reported at fair value. Fair value is 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 other income (expense). 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, 2017 or December 31, 2016. 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, 2017 and December 31, 2016, all of the Company’s investments had contractual maturities of less than one year. The following table summarizes the amortized cost, unrealized gains and losses and the fair value at September 30, 2017 and December 31, 2016: September 30, 2017 Amortized Cost Gross Unrealized Losses Gross Unrealized Gains Fair Value Money Market Funds included in Cash Equivalents $ 2,605,588 $ - $ - $ 2,605,588 U.S. Government Securities 998,940 - 80 999,020 Corporate Securities 4,999,877 (479 ) 200 4,999,598 Commercial Paper 797,695 - - 797,695 Subtotal 6,796,512 (479 ) 280 6,796,313 Total September 30, 2017 $ 9,402,100 $ (479 ) $ 280 $ 9,401,901 December 31, 2016 Money Market Funds included in Cash Equivalents $ 95,949 $ - $ - $ 95,949 Corporate Securities 10,619,583 (13,212 ) - 10,606,371 Commercial Paper 1,494,549 - - 1,494,549 Subtotal 12,114,132 (13,212 ) - 12,100,920 Total December 31, 2016 $ 12,210,081 $ (13,212 ) $ - $ 12,196,869
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, accrued expenses and warrant derivatives (see Note 3 – Stockholders’ Equity, Warrants). 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 in 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, 2017 and December 31, 2016: September 30, 2017 Carrying Value Level 1 Level 2 Level 3 Money Market Funds $ 2,605,588 $ 2,605,588 $ - $ - U.S. Government Securities 999,020 - 999,020 - Corporate Securities 4,999,598 - 4,999,598 - Commercial Paper 797,695 - 797,695 - Subtotal 6,796,313 - 6,796,313 - Total September 30, 2017 $ 9,401,901 $ 2,605,588 $ 6,796,313 - December 31, 2016 Money Market Funds $ 95,949 $ 95,949 $ - - Corporate Securities 10,606,371 - 10,606,371 - Commercial Paper 1,494,549 - 1,494,549 - Subtotal 12,100,920 - 12,100,920 - Total December 31, 2016 $ 12,196,869 $ 95,949 $ 12,100,920 $ -
Foreign Currency Translation and Transactions	The 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 period in which the income and expenses were recognized. Translation gains and losses are included in other comprehensive loss. The Company has intercompany loans between the parent company based in New Jersey and its German subsidiary. The intercompany loans outstanding are not expected to be repaid in the foreseeable future and unrealized foreign exchange movements related to long-term intercompany loans are recognized in other comprehensive income. 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.
Restricted Cash	As of September 30, 2017 and December 31, 2016, the Company’s restricted cash is in connection with the patent and utility model infringement proceedings against TauroPharm (see Note 5). 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 furthermore had to provide a deposit in the amount of $40,000 in connection with the unfair competition proceedings in Cologne.
Prepaid Research and Development	Prepaid research and development expenses consist of payments made in advance to vendors relating to service contracts for clinical trial development and other research and development. 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 net realizable value 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, 2017 December 31, 2016 Raw materials $ 290,970 $ 79,900 Work in process 158,997 463,897 Finished goods 79,518 52,936 Inventory reserve (230,000 ) (430,000 ) Total $ 299,485 $ 166,733
Accrued Expenses	Accrued expenses consist of the following: September 30, 2017 December 31, 2016 Professional and consulting fees $ 235,435 $ 335,198 Accrued payroll and payroll taxes 801,774 737,607 Clinical trial and manufacturing development 1,433,827 875,500 Product development 80,001 374,839 Market research 116,466 - Other 90,061 19,208 Total $ 2,757,564 $ 2,342,352
Derivative Liability	The Company does not use derivative instruments to hedge exposures to cash flow, market or foreign currency risks; however, the Company has certain financial instruments that qualify as derivatives and are classified as liabilities on the balance sheet. The Company evaluates all its financial instruments to determine if those instruments or any potential embedded components of those instruments qualify as derivatives that need to be separately accounted for in accordance with FASB ASC 815, “Derivatives and Hedging” The Company accounts for stock warrants as either equity instruments or derivative liabilities depending on the specific terms of the warrant agreement. Stock warrants are classified as derivative liabilities if they can be cash settled or if there are insufficient authorized and unissued shares available to settle the contract after considering all other commitments that may require the issuance of stock during the maximum period the warrant could remain outstanding. Liability classified warrants are adjusted to their estimated fair values at each reporting period, with any decrease or increase in the estimated fair value being recorded in other income (expense). In May 2017, the Company issued warrants that were liability-classified because there were insufficient shares of common stock available to settle the contracts. The carrying values of those warrants were adjusted to their estimated fair values at June 30, 2017 and again during the third quarter when sufficient additional common shares were authorized to cause the warrants to be reclassified as equity. The fair values on the issuance date and subsequent re-measurement dates were estimated using a probability-weighted option pricing model, requiring assumptions to be developed under different scenarios for the expected term, expected volatility, expected dividend yield and the risk-free interest rate. The Company estimated the expected term of the warrants based on the remaining contractual term. Expected volatility was calculated based on implied volatility of the stock price. The expected dividend yield is assumed to be zero in all scenarios because the Company have never, and have no plans at this time, to pay any dividends. To determine the risk free interest rate, the Company used the U.S. Treasury yield curve in effect at the time of the measurement with a term consistent with the remaining expected term of the warrant.
Revenue Recognition	Revenue is recognized from product sales when the following four revenue recognition criteria are met: persuasive evidence of an arrangement exists, delivery has occurred, the selling price is fixed or determinable, and collectability is reasonably assured. The Company recognizes revenue once the four revenue recognition criteria are met in accordance with the terms of its various distribution agreements.
Deferred Revenue	In October 2015, the Company shipped product with less than 75% of its remaining shelf life to a customer and issued a guarantee that the specific product shipped would be replaced by the Company if the customer was not able to sell the product before it expired. Due to limited sales experience with the customer, the Company was unable to estimate the amount of the warranty obligation that may be incurred as a result of this shipment. Therefore, the Company deferred the revenue and related cost of sales associated with this shipment as net within deferred revenue in the condensed consolidated balance sheet. During the three and nine months ended September 30, 2017, the Company recognized $35,700 and $101,600 of deferred revenue and $21,000 and $59,700 in related cost of sales resulting in the net revenue recognition amounts of $14,700 and $41,900, respectively. Also, during the three and nine months ended September 30, 2017, the Company had recorded an additional net deferred revenue of $0 and $24,000, respectively. Deferred revenue, net at September 30, 2017 and December 31, 2016 amounted to approximately $86,600 and $104,200, respectively.
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. 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. Nine Months Ended September 30, 2017 2016 Series C non-voting convertible preferred stock 2,540,000 2,865,000 Series D non-voting convertible preferred stock 1,479,240 1,479,240 Series E non-voting convertible preferred stock 1,959,759 1,959,759 Shares underlying outstanding warrants 23,189,284 4,006,468 Shares underlying restricted stock units 61,414 - Shares underlying outstanding stock options 4,946,429 4,637,255 Total 34,176,126 14,947,722 Shares underlying outstanding warrants include an aggregate of 29,046,110 warrants issued on an underwritten public offering which closed on May 3, 2017 (see Note 3) of which 9,549,999 warrants were exchanged for 2,387,500 shares of common stock during the quarter ended September 30, 2017.
Stock-Based Compensation	Share-based compensation cost is measured at grant date, based on the estimated fair value of the award using the Black-Scholes option pricing model for options with service or performance-based conditions and a Monte Carlo option pricing model for options with market conditions. Stock-based compensation is recognized as expense over the employee’s requisite service period on a straight-line basis. Effective October 1, 2016, the Company early adopted ASU 2016-09 to account for forfeitures as they occur. All share-based awards will be recognized on a straight-line method, assuming all awards granted will vest. Forfeitures of share-based awards will be recognized in the period in which the forfeitures occur. Prior to the adoption of ASU 2016-09, share-based compensation expense was recognized by applying the expected forfeiture rate during the vesting period to the fair value of the award. As a result of the adoption of ASU 2016-09, the Company’s condensed consolidated statement of operations and comprehensive loss and condensed consolidated statement of cash flows for the three and nine months ended September 30, 2016 were adjusted to reflect the impact. 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, “Compensation-Stock Compensation” “Equity-Based Payments to Non-Employees”
Research and Development	Research and development costs are charged to expense as incurred. Research and development includes fees associated with operational consultants, contract clinical research organizations, contract manufacturing organizations, clinical site fees, contract laboratory research organizations, contract central testing laboratories, licensing activities, and allocated executive, human resources and facilities expenses. The Company accrues for costs incurred as the services are being provided by monitoring the status of the trial and the invoices received from its external service providers. As actual costs become known, the Company adjusts its accruals in the period when actual costs become known. Costs related to the acquisition of technology rights and patents for which development work is still in process are charged to operations as incurred and considered a component of research and development expense.
Recent Authoritative Pronouncements	In May 2014, the FASB issued new guidance related to how an entity should recognize revenue. The guidance specifies that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods and services. In addition, the guidance expands the required disclosures related to revenue and cash flows from contracts with customers. In April 2016 and May 2016, the FASB issued updates in order to provide improvements and clarifications to the revenue recognition guidance. In certain customer arrangements, under current GAAP, the Company has deferred revenue for certain product sales a result of the ability for the customer to return the product under certain conditions. Under the new standard, the Company will be required to estimate expected revenue at the point of sale. The Company will adopt the new revenue recognition standard as of January 1, 2018 using the modified retrospective method. In July 2017, the FASB issued new guidance which changes the classification analysis of certain equity-linked financial instruments (or embedded features) with down round features and recharacterizes the indefinite deferral of certain provisions within the guidance for distinguishing liabilities from equity. The guidance is effective for the Company beginning in the first quarter of fiscal year 2019. Early adoption is permitted. The Company is evaluating the impact of adopting this guidance on its consolidated financial statements.

2. Summary of Significant Acc15

2. Summary of Significant Accounting Policies (Tables)	9 Months Ended
	Sep. 30, 2017
Accounting Policies [Abstract]
Marketable securities	September 30, 2017 Amortized Cost Gross Unrealized Losses Gross Unrealized Gains Fair Value Money Market Funds included in Cash Equivalents $ 2,605,588 $ - $ - $ 2,605,588 U.S. Government Securities 998,940 - 80 999,020 Corporate Securities 4,999,877 (479 ) 200 4,999,598 Commercial Paper 797,695 - - 797,695 Subtotal 6,796,512 (479 ) 280 6,796,313 Total September 30, 2017 $ 9,402,100 $ (479 ) $ 280 $ 9,401,901 December 31, 2016 Money Market Funds included in Cash Equivalents $ 95,949 $ - $ - $ 95,949 Corporate Securities 10,619,583 (13,212 ) - 10,606,371 Commercial Paper 1,494,549 - - 1,494,549 Subtotal 12,114,132 (13,212 ) - 12,100,920 Total December 31, 2016 $ 12,210,081 $ (13,212 ) $ - $ 12,196,869
Carrying and fair value of financial assets	September 30, 2017 Carrying Value Level 1 Level 2 Level 3 Money Market Funds $ 2,605,588 $ 2,605,588 $ - $ - U.S. Government Securities 999,020 - 999,020 - Corporate Securities 4,999,598 - 4,999,598 - Commercial Paper 797,695 - 797,695 - Subtotal 6,796,313 - 6,796,313 - Total September 30, 2017 $ 9,401,901 $ 2,605,588 $ 6,796,313 - December 31, 2016 Money Market Funds $ 95,949 $ 95,949 $ - - Corporate Securities 10,606,371 - 10,606,371 - Commercial Paper 1,494,549 - 1,494,549 - Subtotal 12,100,920 - 12,100,920 - Total December 31, 2016 $ 12,196,869 $ 95,949 $ 12,100,920 $ -
Schedule of inventories	September 30, 2017 December 31, 2016 Raw materials $ 290,970 $ 79,900 Work in process 158,997 463,897 Finished goods 79,518 52,936 Inventory reserve (230,000 ) (430,000 ) Total $ 299,485 $ 166,733
Schedule of accrued expenses	September 30, 2017 December 31, 2016 Professional and consulting fees $ 235,435 $ 335,198 Accrued payroll and payroll taxes 801,774 737,607 Clinical trial and manufacturing development 1,433,827 875,500 Product development 80,001 374,839 Market research 116,466 - Other 90,061 19,208 Total $ 2,757,564 $ 2,342,352
Schedule of anti-dilutive securities excluded from calculation of diluted net loss per share	Nine Months Ended September 30, 2017 2016 Series C non-voting convertible preferred stock 2,540,000 2,865,000 Series D non-voting convertible preferred stock 1,479,240 1,479,240 Series E non-voting convertible preferred stock 1,959,759 1,959,759 Shares underlying outstanding warrants 23,189,284 4,006,468 Shares underlying restricted stock units 61,414 - Shares underlying outstanding stock options 4,946,429 4,637,255 Total 34,176,126 14,947,722

3. Stockholders' Equity (Tables

3. Stockholders' Equity (Tables)	9 Months Ended
	Sep. 30, 2017
STOCKHOLDERS' EQUITY
Fair value assumptions for Black Sholes	Nine Months Ended September 30, 2017 2016 Expected Term 5 years 5 – 10 years Volatility 99.85% - 105.07% 96% - 98% Dividend yield 0.0% 0.0% Risk-free interest rate 1.77% - 1.99% 1.14% - 1.94% Weighted average fair value of options granted during the period $1.21 $ 1.76
Summary of Option Activity under Plan and Related Information	Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Outstanding at beginning of period 4,609,755 $ 2.29 8.2 $ 581,823 Exercised (10,000 ) $ 0.68 13,200 Forfeited (433,116 ) $ 1.85 Expired/Canceled (562,710 ) $ 2.99 Granted 1,342,500 $ 1.57 Outstanding at end of period 4,946,429 $ 2.05 7.7 $ 0 Vested at end of period 2,152,520 $ 1.82 6.0 $ 0
Summary of Warrant Activity	Series A Series B Underwriter’s Expected Term 1.18 – 1.33 years 5.10 – 5.25 years 5.10 – 5.25 years Volatility 55% 55% 55% Dividend yield 0.0% 0.0% 0.0% Exercise Price $0.75 $1.05 $0.94 Risk-free interest rate 1.13% - 1.16% 1.86% - 1.88% 1.86% - 1.88% Weighted average fair value of warrants granted $0.08 $0.17 $0.18 Number of shares underlying warrants granted 13,964,476 13,964,476 1,117,158 As these warrants are liability-classified, they were revalued at August 10, 2017 using the following assumptions: Series A Series B Underwriter’s Expected Term 1.09 5.00 5.00 Volatility 96.95% 96.95% 96.95% Dividend yield 0.0% 0.0% 0.0% Exercise Price $ 0.75 $ 1.05 $ 0.94 Risk-free interest rate 1.22% 1.76% 1.76% Weighted average fair value of warrants $ 0.06 $ 0.20 $ 0.20

2. Summary of Significant Acc17

2. Summary of Significant Accounting Policies (Details) - USD ($)	9 Months Ended	12 Months Ended
	Sep. 30, 2017	Dec. 31, 2016
Amortized cost	$ 9,402,100	$ 12,210,081
Gross unrealized losses	(479)	(13,212)
Gross unrealized gains	280	0
Fair value	9,401,901	12,196,869
Money Market Funds included in Cash Equivalents
Amortized cost	2,605,588	95,949
Gross unrealized losses	0	0
Gross unrealized gains	0	0
Fair value	2,605,588	95,949
U.S. Government Securities
Amortized cost	998,940	0
Gross unrealized losses	0	0
Gross unrealized gains	80	0
Fair value	999,020	0
Corporate Securities
Amortized cost	4,999,877	10,619,583
Gross unrealized losses	(479)	(13,212)
Gross unrealized gains	200	0
Fair value	4,999,598	10,606,371
Commercial Paper
Amortized cost	797,695	1,494,549
Gross unrealized losses	0	0
Gross unrealized gains	0	0
Fair value	797,695	1,494,549
Subtotal
Amortized cost	6,796,512	12,114,132
Gross unrealized losses	(479)	(13,212)
Gross unrealized gains	280	0
Fair value	$ 6,796,313	$ 12,100,920

2. Summary of Significant Acc18

2. Summary of Significant Accounting Policies (Details 1) - USD ($)	Sep. 30, 2017	Dec. 31, 2016
Carrying Value	$ 9,401,901	$ 12,196,869
Level 1
Carrying Value	2,605,588	95,949
Level 2
Carrying Value	6,796,313	12,100,920
Level 3
Carrying Value	0	0
Money Market Funds included in Cash Equivalents
Carrying Value	2,605,588	95,949
Money Market Funds included in Cash Equivalents | Level 1
Carrying Value	2,605,588	95,949
Money Market Funds included in Cash Equivalents | Level 2
Carrying Value	0	0
Money Market Funds included in Cash Equivalents | Level 3
Carrying Value	0	0
U.S. Government Securities
Carrying Value	999,020
U.S. Government Securities | Level 1
Carrying Value	0
U.S. Government Securities | Level 2
Carrying Value	999,020
U.S. Government Securities | Level 3
Carrying Value	0
Corporate Securities
Carrying Value	4,999,598	10,606,371
Corporate Securities | Level 1
Carrying Value	0	0
Corporate Securities | Level 2
Carrying Value	4,999,598	10,606,371
Corporate Securities | Level 3
Carrying Value	0	0
Commercial Paper
Carrying Value	797,695	1,494,549
Commercial Paper | Level 1
Carrying Value	0	0
Commercial Paper | Level 2
Carrying Value	797,695	1,494,549
Commercial Paper | Level 3
Carrying Value	0	0
Subtotal
Carrying Value	6,796,313	12,100,920
Subtotal | Level 1
Carrying Value	0	0
Subtotal | Level 2
Carrying Value	6,796,313	12,100,920
Subtotal | Level 3
Carrying Value	$ 0	$ 0

2. Summary of Significant Acc19

2. Summary of Significant Accounting Policies (Details 2) - USD ($)	Sep. 30, 2017	Dec. 31, 2016
Summary Of Significant Accounting Policies Details 2
Raw materials	$ 290,970	$ 79,900
Work in process	158,997	463,897
Finished goods	79,518	52,936
Inventory reserve	(230,000)	(430,000)
Total	$ 299,485	$ 166,733

2. Summary of Significant Acc20

2. Summary of Significant Accounting Policies (Details 3) - USD ($)	Sep. 30, 2017	Dec. 31, 2016
Accounting Policies [Abstract]
Professional and consulting fees	$ 235,435	$ 335,198
Accrued payroll and payroll taxes	801,774	737,607
Clinical trial and manufacturing development	1,433,827	875,500
Product development	80,001	374,839
Market research	116,466	0
Other	90,061	19,208
Total	$ 2,757,564	$ 2,342,352

2. Summary of Significant Acc21

2. Summary of Significant Accounting Policies (Details 4) - shares	9 Months Ended
	Sep. 30, 2017	Sep. 30, 2016
Antidilutive Shares	34,176,126	14,947,722
Series C non-voting convertible preferred stock
Antidilutive Shares	2,540,000	2,865,000
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	1,959,759
Warrants
Antidilutive Shares	23,189,284	4,006,468
Shares underlying restricted stock units
Antidilutive Shares	61,414	0
Shares underlying outstanding stock options
Antidilutive Shares	4,946,429	4,637,255

2. Summary of Significant Acc22

2. Summary of Significant Accounting Policies (Details Narrative) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2017	Sep. 30, 2016	Sep. 30, 2017	Sep. 30, 2016	Dec. 31, 2016
Summary Of Significant Accounting Policies Details Narrative
Accumulated deficit	$ (141,864,346)		$ (141,864,346)		$ (119,164,952)
Loss from Operations	(8,011,971)	$ (9,157,975)	(22,653,579)	$ (18,331,525)
Deferred revenue	86,600		86,600		$ 104,200
Deferred revenue recognized	35,700		101,600
Cost of sales recognized	21,000		59,700
Net deferred revenue recognized	$ 14,700		$ 41,900

3. Stockholders' Equity (Detail

3. Stockholders' Equity (Details) - $ / shares	9 Months Ended
	Sep. 30, 2017	Sep. 30, 2016
Stockholders Equity Details
Expected Term	5 years
Expected Term, minimum		5 years
Expected Term, maximum		10 years
Volatility, minimum	99.85%	96.00%
Volatility, maximum	105.07%	98.00%
Dividend yield	0.00%	0.00%
Risk-free interest rate, minimum	1.77%	1.14%
Risk-free interest rate, maximum	1.99%	1.94%
Weighted-average fair value of options granted during the period	$ 1.21	$ 1.76

3. Stockholders' Equity (Deta24

3. Stockholders' Equity (Details 1) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2017	Sep. 30, 2016	Sep. 30, 2017	Sep. 30, 2016
Stockholders Equity Details 1
Number of Options Outstanding, Beginning			4,609,755
Number of Options Exercised			(10,000)
Number of Options Forfeited			(433,116)
Number of Options Expired/Canceled			(562,710)
Number of Options Granted			1,342,500
Number of Options Outstanding, Ending	4,946,429		4,946,429
Number of Options Vested	2,152,520		2,152,520
Weighted Average Exercise Price Outstanding, Beginning			$ 2.29
Weighted Average Exercise Price Exercised			.68
Weighted Average Exercise Price Forfeited			1.85
Weighted Average Exercise Price Expired/Canceled			2.99
Weighted Average Exercise Price Granted			1.57
Weighted Average Exercise Price Outstanding, Ending	$ 2.05		2.05
Weighted Average Exercise Price, Vested	$ 1.82		$ 1.82
Weighted Average Remaining Contractual Life (in years) Outstanding, Beginning			8 years 2 months 12 days
Weighted Average Remaining Contractual Life (in years) Outstanding, Ending			7 years 8 months 12 days
Weighted Average Remaining Contractual Life (in years), Vested			6 years
Aggregate Intrinsic Value Outstanding, Beginning			$ 581,823
Aggregate Intrinsic Value, Exercised	$ 0	$ 486,550	13,200	$ 1,466,589
Aggregate Intrinsic Value Outstanding, Ending	0		0
Aggregate Intrinsic Value, Vested	$ 0		$ 0

3. Stockholders' Equity (Deta25

3. Stockholders' Equity (Details 2) - $ / shares	9 Months Ended
	Sep. 30, 2017	Sep. 30, 2016
Expected Term	5 years
Expected Term, minimum		5 years
Expected Term, maximum		10 years
Volatility, minimum	99.85%	96.00%
Volatility, maximum	105.07%	98.00%
Dividend yield	0.00%	0.00%
Risk-free interest rate, minimum	1.77%	1.14%
Risk-free interest rate, maximum	1.99%	1.94%
Weighted-average fair value of warrants granted during the period	$ 1.21	$ 1.76
Series A
Expected Term	1 year 1 month 2 days
Volatility	96.95%
Dividend yield	0.00%
Exercise Price	$ .75
Risk-free interest rate	1.22%
Weighted-average fair value of warrants granted during the period	$ .06
Series A | Grant Date
Expected Term, minimum	1 year 2 months 5 days
Expected Term, maximum	1 year 3 months 29 days
Volatility	55.00%
Dividend yield	0.00%
Exercise Price	$ .75
Risk-free interest rate, minimum	1.13%
Risk-free interest rate, maximum	1.16%
Weighted-average fair value of warrants granted during the period	$ .08
Number of shares underlying warrants granted	13,964,476
Series B
Expected Term	5 years
Volatility	96.95%
Dividend yield	0.00%
Exercise Price	$ 1.05
Risk-free interest rate	1.76%
Weighted-average fair value of warrants granted during the period	$ .20
Series B | Grant Date
Expected Term, minimum	5 years 1 month 6 days
Expected Term, maximum	5 years 3 months
Volatility	55.00%
Dividend yield	0.00%
Exercise Price	$ 1.05
Risk-free interest rate, minimum	1.86%
Risk-free interest rate, maximum	1.88%
Weighted-average fair value of warrants granted during the period	$ .17
Number of shares underlying warrants granted	13,964,476
Underwriter's
Expected Term	5 years
Volatility	96.95%
Dividend yield	0.00%
Exercise Price	$ .94
Risk-free interest rate	1.76%
Weighted-average fair value of warrants granted during the period	$ .20
Underwriter's | Grant Date
Expected Term, minimum	5 years 1 month 6 days
Expected Term, maximum	5 years 3 months
Volatility	55.00%
Dividend yield	0.00%
Exercise Price	$ .94
Risk-free interest rate, minimum	1.86%
Risk-free interest rate, maximum	1.88%
Weighted-average fair value of warrants granted during the period	$ .18
Number of shares underlying warrants granted	1,117,158

3. Stockholders' Equity (Deta26

3. Stockholders' Equity (Details Narrative) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2017	Sep. 30, 2016	Sep. 30, 2017	Sep. 30, 2016
Common stock			10,000
Stock option gross proceeds			$ 6,800
Conversion of preferred stock to common stock			325,000
Stock-based compensation for stock options issued	$ 388,616	$ 192,685	$ 1,202,260	$ 920,864
Unrecognized compensation expense	3,184,000		$ 3,184,000
Warrants, weighted average remaining contractual life			1 year 6 months
Intrinsic value of stock options exercised	0	$ 486,550	$ 13,200	$ 1,466,589
Outstanding warrants			23,189,284
Restricted Stock Unit
Compensation expense	26,019		$ 62,017
Unrecognized compensation expense	$ 73,387		$ 73,387
Restricted stock units issued			107,931

5. Commitments and Contingenc27

5. Commitments and Contingencies (Details Narrative) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2017	Sep. 30, 2016	Sep. 30, 2017	Sep. 30, 2016
Commitments And Contingencies Details Narrative
Research and development expenses - manufacturing	$ 523,000	$ 777,000	$ 1,416,000	$ 1,510,000
Research and development expense - clinical and regulatory	3,731,000	1,801,000	9,097,000	3,804,000
Rent expense	$ 7,000	$ 17,000	43,000	$ 51,000
Agreements amount, maximum			3,000,000
Unearned aggregate amount			$ 2,500,000

6. Concentrations (Details Narr

6. Concentrations (Details Narrative)	9 Months Ended
	Sep. 30, 2017
Concentrations Details Narrative
Concentration risk	97.00%