CorMedix (CRMD) 10-Q 9 Nov 16 2016 Q3 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	9 Months Ended
	Sep. 30, 2016	Nov. 04, 2016
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, 2016
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		40,425,739
Document Fiscal Period Focus	Q3
Document Fiscal Year Focus	2,016

CONDENSED CONSOLIDATED BALANCE

CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($)	Sep. 30, 2016	Dec. 31, 2015
Current assets
Cash and cash equivalents	$ 9,826,947	$ 11,817,418
Restricted cash	171,553	171,553
Short-term investments	16,826,712	23,568,386
Trade receivables	22,035	315,771
Inventories, net	118,207	376,569
Prepaid research and development expenses	1,323,743	430,162
Other prepaid expenses and current assets	470,391	379,004
Total current assets	28,759,588	37,058,863
Property and equipment, net	75,843	37,866
Security deposit	5,000	5,000
TOTAL ASSETS	28,840,431	37,101,729
Current liabilities
Accounts payable	1,758,180	1,709,397
Accrued expenses	3,149,726	1,221,557
Deferred revenue	131,066	130,409
Total current liabilities	5,038,972	3,061,363
Deferred revenue, long term	22,093	28,878
TOTAL LIABILITIES	5,061,065	3,090,241
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS' EQUITY
Preferred stock - $0.001 par value: 2,000,000 shares authorized; 450,085 shares issued and outstanding at September 30, 2016 and December 31, 2015	450	450
Common stock - $0.001 par value: 80,000,000 shares authorized; 40,405,739 and 35,963,348 shares issued at September 30, 2016 and December 31, 2015, respectively, 40,359,644 and 35,879,769 outstanding at September 30, 2016 and December 31, 2015, respectively	40,406	35,964
Accumulated other comprehensive income	83,298	62,130
Additional paid-in capital	136,291,018	128,304,539
Accumulated deficit	(112,635,806)	(94,391,595)
TOTAL STOCKHOLDERS' EQUITY	23,779,366	34,011,488
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$ 28,840,431	$ 37,101,729

CONDENSED CONSOLIDATED BALANCE3

CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares	Sep. 30, 2016	Dec. 31, 2015
Statement of Financial Position [Abstract]
Preferred stock, par value	$ 0.001	$ 0.001
Preferred stock, shares authorized	2,000,000	2,000,000
Preferred stock, shares issued	450,085	450,085
Preferred stock, shares outstanding	450,085	450,085
Common stock, par value	$ 0.001	$ 0.001
Common stock, shares authorized	80,000,000	80,000,000
Common stock, shares issued	40,405,739	35,963,348
Common stock, shares outstanding	40,405,739	35,963,348

CONDENSED CONSOLIDATED STATEMEN

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE GAIN (LOSS) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2016	Sep. 30, 2015	Sep. 30, 2016	Sep. 30, 2015
Revenue
Net sales	$ 44,451	$ 35,947	$ 102,390	$ 187,184
Cost of sales	(43,922)	(35,396)	(281,342)	(154,514)
Gross profit (loss)	529	551	(178,952)	32,670
Operating Expenses
Research and development	(6,840,413)	(1,764,468)	(11,702,965)	(4,796,571)
Selling, general and administrative	(2,318,091)	(2,948,643)	(6,449,608)	(7,996,922)
Total Operating Expenses	(9,158,504)	(4,713,111)	(18,152,573)	(12,793,493)
Loss From Operations	(9,157,975)	(4,712,560)	(18,331,525)	(12,760,823)
Other Income (Expense)
Interest income	32,866	25,019	93,928	30,817
Foreign exchange transaction gain (loss)	(1,091)	674	(5,622)	(5,352)
Value of warrants issued in connection with backstop financing	0	0	0	(1,583,252)
Interest expense	0	(1,609)	(992)	(2,635)
Total Other Income (Expense)	31,775	24,084	87,314	(1,560,422)
Net Loss	(9,126,200)	(4,688,476)	(18,244,211)	(14,321,245)
Other Comprehensive Income (Loss):
Unrealized gain (loss) from investments	(6,765)	5,852	17,233	348
Foreign currency translation gain (loss)	(82)	1,230	3,935	466
Total Other Comprehensive Income (Loss)	(6,847)	7,082	21,168	814
Comprehensive Loss	(9,133,047)	(4,681,394)	(18,223,043)	(14,320,431)
Net loss	(9,126,200)	(4,688,476)	(18,244,211)	(14,321,245)
Dividends, including deemed dividends	0	0	0	(33,121)
Net Loss Attributable To Common Shareholders	$ (9,126,200)	$ (4,688,476)	$ (18,244,211)	$ (14,354,366)
Net Loss Per Common Share - Basic and Diluted	$ (0.23)	$ (0.14)	$ (0.49)	$ (0.48)
Weighted Average Common Shares Outstanding - Basic and Diluted	39,053,956	34,585,543	37,156,790	30,082,478

CONDENSED CONSOLIDATED STATEME5

CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS' EQUITY - 9 months ended Sep. 30, 2016 - 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 (in shares) at Dec. 31, 2015	35,963,348	450,085
Beginning balance at Dec. 31, 2015	$ 35,964	$ 450	$ 62,130	$ 128,304,539	$ (94,391,595)	$ 34,011,488
Stock issued in connection with sale of common stock, net, Shares	3,353,437
Stock issued in connection with sale of common stock, net, Amount	$ 3,353			6,217,203		6,220,556
Stock issued in connection with warrants cashless exercised, Shares	21,454
Stock issued in connection with warrants cashless exercised, Amount	$ 21			(21)		0
Stock issued in connection with stock options exercised, Shares	1,067,500
Stock issued in connection with stock options exercised, Amount	$ 1,068			848,433		849,501
Stock-based compensation				920,864		920,864
Other comprehensive income			21,168			21,168
Net loss					(18,244,211)	(18,244,211)
Ending balance (in shares) at Sep. 30, 2016	40,405,739	450,085
Ending balance at Sep. 30, 2016	$ 40,406	$ 450	$ 83,298	$ 136,291,018	$ (112,635,806)	$ 23,779,366

CONDENSED CONSOLIDATED STATEME6

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($)	9 Months Ended
	Sep. 30, 2016	Sep. 30, 2015
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$ (18,244,211)	$ (14,321,245)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation	920,864	2,908,855
Value of warrants issued in connection with backstop financing	0	1,583,252
Modification of warrant agreement	0	112,982
Inventory reserve	166,000	0
Depreciation	16,923	11,087
Changes in operating assets and liabilities:
Restricted cash	0	(171,553)
Trade receivables	301,169	(50,178)
Inventory	92,361	(236,120)
Prepaid expenses and other current assets	(981,963)	(247,431)
Accounts payable	47,233	538,533
Accrued expenses and accrued interest	1,921,043	988,198
Deferred revenue	(6,786)	(8,221)
Net cash used in operating activities	(15,767,367)	(8,891,841)
CASH FLOWS FROM INVESTING ACTIVITIES:
Sale (purchase) of short-term investments	6,758,906	(23,604,267)
Purchase of equipment	(55,107)	(13,796)
Net cash provided by (used in) investing activities	6,703,799	(23,618,063)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from sale of common stock from an at-the-market program, net	6,220,556	27,242,752
Proceeds from exercise of warrants	0	14,658,161
Proceeds from short swing profit recovery	0	28,594
Proceeds from exercise of stock options	849,501	492,960
Net cash provided by financing activities	7,070,057	42,422,467
Foreign exchange effect on cash	3,040	(5,124)
NET INCREASE (DECREASE) IN CASH	(1,990,471)	9,907,439
CASH - BEGINNING OF PERIOD	11,817,418	4,339,540
CASH - END OF PERIOD	9,826,947	14,246,979
Cash paid for interest	992	2,635
Supplemental Disclosure of Non-Cash Financing Activities:
Conversion of preferred stock to common stock	0	500
Conversion of wages to common stock	0	50,000
Dividends, including deemed dividends	$ 0	$ 33,121

1. Organization, Business and B

1. Organization, Business and Basis of Presentation	9 Months Ended
	Sep. 30, 2016
Organization Business And Basis Of Presentation
Organization, Business and Basis of Presentation	Organization and Business CorMedix Inc. (“CorMedix” or the “Company”) is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases. The Company was incorporated in the State of Delaware on July 28, 2006. In 2013, the Company formed a wholly-owned subsidiary, CorMedix Europe GmbH. The Company’s primary focus is on the development of its lead product candidate, Neutrolin ® ® The United States Food and Drug Administration, or FDA, has designated Neutrolin as a Qualified Infectious Disease Product (QIDP) for prevention of catheter related blood stream infections in patients with end stage renal disease receiving hemodialysis through a central venous catheter. Catheter-related blood stream infections and clotting can be life-threatening. The QIDP designation provides an additional five years of market exclusivity in addition to the five years granted for a New Chemical Entity. In addition, in January 2015, the FDA granted Fast Track designation to Neutrolin Catheter Lock Solution, pursuant to the Food and Drug Administration Safety Innovation Act (FDASIA) highlighting the large unmet need to prevent infections in the U.S. healthcare system. The Fast Track designation of Neutrolin provides the Company with the opportunity to meet with the FDA on a more frequent basis during the development process, and also provides eligibility to request priority review of the marketing application. In late 2013, the Company met with the FDA to determine the pathway for U.S. marketing approval of Neutrolin. Based on those discussions, the Company plans to conduct two pivotal trials to demonstrate the safety and effectiveness of Neutrolin to secure marketing approval. The Company initiated one Phase 3 clinical trial in hemodialysis patients with a central venous catheter in December 2015 and plans to initiate one Phase 3 clinical trial in oncology patients with catheters. The Company launched its Phase 3 clinical trial in hemodialysis 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, placebo-controlled, 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. The primary endpoint for the trial is time to CRBSI. The trial will evaluate whether Neutrolin is superior to the active control heparin by documenting the incidence of CRBSI and the time until the occurrence of CRBSI. Key secondary endpoints are catheter patency which is defined as required use of tissue plasminogen activating factor (tPA) or removal of catheter due to dysfunction and catheter removal for any reason. The Company plans also include conducting a Phase 3 clinical trial in oncology patients with catheters, or LOCK-IT-200. The Company is in discussion with the FDA to develop the design of the trial. Such plans are also subject to funding requirements (see Note 2). The Company received CE Mark approval for Neutrolin in 2013 and began the commercial launch of Neutrolin in Germany for the prevention of catheter-related bloodstream infections and maintenance of catheter patency in hemodialysis patients using a tunneled, cuffed central venous catheter for vascular access. To date, Neutrolin is registered and may be sold in certain European Union and Middle Eastern countries for such treatment. In September 2014, the TUV-SUD and The Medicines Evaluation Board of the Netherlands granted a label expansion for Neutrolin for expanded indications for the European Union (“EU”). In December 2014, the Company received approval from the Hessian District President in Germany to expand the label to include use in oncology patients receiving chemotherapy, IV hydration and IV medications via central venous catheters. The expansion also adds patients receiving medication and IV fluids via central venous catheters in intensive or critical care units (cardiac care unit, surgical care unit, neonatal critical care unit, and urgent care centers). An indication for use in total parenteral, or IV, nutrition was also approved. 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, 2016 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 15, 2016. The accompanying condensed balance sheet as of December 31, 2015 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, 2016
Accounting Policies [Abstract]
Summary of Significant Accounting Policies	Liquidity and Going Concern The Company’s operations are subject to a number of factors that can affect its operating results and financial condition. Such factors include, but are not limited to: the results of clinical testing and trial activities of the Company’s product candidates; the ability to obtain regulatory approval to market the Company’s products; ability to manufacture successfully; competition from products manufactured and sold or being developed by other companies; the price of, and demand for, Company products; the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products; and the Company’s ability to raise capital to support its operations. To date, the Company’s commercial operations have not generated enough revenues to enable profitability. As of September 30, 2016, the Company had an accumulated deficit of $112.6 million, and incurred losses from operations of $18.2 million and $9.1 million for the nine and three months then ended, respectively. Based on the 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 the Company’s other operating requirements, management believes that the existing cash at September 30, 2016 will not be sufficient to fund operations for at least the next twelve months following the balance sheet date. Additionally, the Company will need additional funding to complete the hemodialysis clinical trial in the U.S. which commenced in December 2015 as well as to initiate the planned Phase 3 clinical trial in oncology patients with catheters. At September 30, 2016, the Company had $4.1 million available under its current at-the-market program. In August 2016, the Company entered into a new sales agreement with the same bank to allow the Company to sell up to $40 million of shares of its common stock. The Company will not and cannot access the ATM program under the new sales agreement unless and until (i) the Company and Elliott Associates, L.P. ("Elliot") agree as to the exercise or waiver of Elliott's participation rights in the new ATM program, which rights were granted in a Consent and Exchange Agreement dated September 15, 2014, and apply to any equity financing we undertake until September 15, 2017, and (ii) the registration statement that includes the prospectus for the new ATM program that the Company filed with the Securities and Exchange Commission is declared effective. At such time, the Company will be able to access the new ATM program and will terminate the current ATM program and the related Sales Agreement. There is no assurance that conditions will allow the Company to raise additional funds available under its at-the-market program. The Company’s continued operations will ultimately depend on its ability to raise additional capital through various potential sources, such as equity and/or debt financings, strategic relationships, or out-licensing of its products in order to complete its ongoing and planned Phase 3 clinical trials and until it achieves profitability, if ever. The Company can provide no assurances that such financing or strategic relationships will be available on acceptable terms, or at all. Without this funding, the Company could be required to delay, scale back or eliminate some or all of its research and development programs which would likely have a material adverse effect on the Company’s business. 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. Cash and Cash Equivalents Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents. The Company maintains its cash and cash equivalents in bank deposits and other interest bearing accounts, the balances of which exceed federally insured limits. Short-Term Investments The Company determines the appropriate classification of marketable securities at the time of purchase and reevaluates such designation as of each balance sheet date. Investments in marketable debt and equity securities classified as available-for-sale are reported at fair value. Fair values of the Company’s investments are determined using quoted market prices in active markets for identical assets or liabilities or quoted prices for similar assets or liabilities or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Changes in fair value that are considered temporary are reported net of tax in other comprehensive income (loss). Realized gains and losses, amortization of premiums and discounts and interest and dividends earned are included in income (expense) on the condensed consolidated statements of operations and comprehensive income (loss). The cost of investments for purposes of computing realized and unrealized gains and losses is based on the specific identification method. For declines in the fair value of equity securities that are considered other-than-temporary, impairment losses are charged to other (income) expense, net. The Company considers available evidence in evaluating potential impairments of its investments, including the duration and extent to which fair value is less than cost. There were no deemed permanent impairments at September 30, 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, 2016, all of the Company’s investments had contractual maturities which were less than one year. The following table summarizes the amortized cost, unrealized gains and losses and the fair value at September 30, 2016 and December 31, 2015 of the Company’s financial assets that are measured on a recurring basis: September 30, 2016: Amortized Cost Gross Unrealized Losses Gross Unrealized Gains Fair Value Money Market Funds included in Cash Equivalents $ 3,310,359 $ - $ - $ 3,310,359 U.S. Government Agency Securities 3,211,974 - 567 3,212,541 Corporate Securities 12,131,193 (7,688) 114 12,123,619 Commercial Paper 1,490,552 - - 1,490,552 Subtotal 16,833,719 (7,688) 681 16,826,712 Total September 30, 2016 $ 20,144,078 $ (7,688) $ 681 $ 20,137,071 December 31, 2015: Money Market Funds included in Cash Equivalents $ 3,353,067 $ - $ - $ 3,353,067 U.S. Government Agency Securities 6,531,914 (3,014) - 6,528,900 Corporate Securities 15,065,595 (21,637) 412 15,044,370 Commercial Paper 1,995,116 - - 1,995,116 Subtotal 23,592,625 (24,651) 412 23,568,386 Total December 31, 2015 $ 26,945,692 $ (24,651) $ 412 $ 26,921,453 Fair Value Measurements The Company’s financial instruments recorded in the consolidated balance sheets include cash and cash equivalents, accounts receivable, investment securities, accounts payable and accrued expenses. The carrying value of certain financial instruments, primarily cash and cash equivalents, accounts receivable, accounts payable, and accrued expenses approximate their estimated fair values based upon the short-term nature of their maturity dates. The Company categorizes its financial instruments into a three-level fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets (Level 1) and the lowest priority to unobservable inputs (Level 3). If the inputs used to measure fair value fall within different levels of the hierarchy, the category level is based on the lowest priority level input that is significant to the fair value measurement of the instrument. Financial assets recorded at fair value on the Company’s condensed consolidated balance sheets are categorized as follows: • Level 1 inputs—Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets. • Level 2 inputs— Significant other observable inputs (e.g., quoted prices for similar items in active markets, quoted prices for identical or similar items in markets that are not active, inputs other than quoted prices that are observable such as interest rate and yield curves, and market-corroborated inputs). • Level 3 inputs—Unobservable inputs for the asset or liability, which are supported by little or no market activity and are valued based on management’s estimates of assumptions that market participants would use in pricing the asset or liability. 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, 2016 and December 31, 2015: September 30, 2016: Carrying Value Level 1 Level 2 Level 3 Money Market Funds $ 3,310,359 $ 3,310,359 $ - $ - US Government Agency Securities 3,212,541 - 3,212,541 - Corporate Securities 12,123,619 - 12,123,619 - Commercial Paper 1,490,552 - 1,490,552 - Subtotal 16,826,712 - 16,826,712 $ - Total September 30, 2016 $ 20,137,071 $ 3,310,359 $ 16,826,712 $ - December 31, 2015: Money Market Funds $ 3,353,067 $ 3,353,067 $ - $ - US Government Agency Securities 6,528,900 - 6,528,900 - Corporate Securities 15,044,370 - 15,044,370 - Commercial Paper 1,995,116 - 1,995,116 - Subtotal 23,568,386 - 23,568,386 $ - Total December 31, 2015 $ 26,921,453 $ 3,353,067 $ 23,568,386 $ - 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 income (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, 2016 and December 31, 2015, 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 and Other Prepaid Expenses Prepaid expenses consist of payments made in advance to vendors relating to service contracts for clinical trial development, manufacturing, preclinical development and insurance policies. These advanced payments are amortized to expense either as services are performed or over the relevant service period using the straight-line method. Inventories, net Inventories are valued at the lower of cost or market on a first in, first out basis. Inventories consist of raw materials (including labeling and packaging), work-in-process, and finished goods for the Neutrolin product. Inventories consist of the following: September 30, 2016 December 31, 2015 Raw materials $ 221,355 $ 244,459 Work in process 355,297 424,622 Finished goods 7,555 7,488 Inventory reserve (466,000) (300,000) Total $ 118,207 $ 376,569 Accrued Expenses Accrued expenses consist of the following: September 30, 2016 December 31, 2015 Professional and consulting fees $ 333,982 $ 282,975 Accrued payroll and payroll taxes 722,823 532,084 Clinical trial and manufacturing development 1,763,889 226,042 Product development 285,915 - Monitoring program fees 20,963 65,076 Statutory taxes 3,307 67,236 Other 18,847 48,144 Total $ 3,149,726 $ 1,221,557 Revenue Recognition The Company recognizes revenue in accordance with SEC Staff Accounting Bulletin (“SAB”) Topic 13, Revenue Recognition Revenue Recognition . Deferred Revenue In October 2015, the Company shipped product with less than 75% of its remaining shelf life to an international distributor 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. As a result of this warranty, the Company may have an additional performance obligation (i.e. accept returned product and deliver new product to the customer) if the customer is unable to sell such product. Due to limited sales experience with the customer, the Company is unable to estimate the amount of the warranty obligation that may be incurred as a result of this shipment. Therefore, the Company has deferred the revenue and related cost of sales associated with the shipment of this product. Since the Company will be unable to resell the expired product if returned by the customer, the deferred revenue and related cost of sales is presented net as Deferred Revenue on the condensed consolidated balance sheet which amounted to approximately $122,000 and $121,000 at September 30, 2016 and December 31, 2015, respectively. During the quarter ended September 30, 2016, the Company recognized $2,400 of revenue net of related cost of sales for this shipment. Additionally, the change in the exchange rate resulted in an increase in the Deferred Revenue balance of $3,000 during the quarter ended September 30, 2106. In August 2014, the Company entered into an exclusive distribution agreement (the “Wonik Agreement”) with Wonik Corporation, a South Korean company, to market, sell and distribute Neutrolin for hemodialysis and oncolytic patients upon receipt of regulatory approval in Korea. Upon execution of the Wonik Agreement, Wonik paid the Company a non-refundable $50,000 payment and will pay an additional $50,000 upon receipt of the product registration necessary to sell Neutrolin in the Republic of Korea (the “Territory”). The term of the Wonik Agreement commenced on August 8, 2014 and will continue for three years after the first commercial sale of Neutrolin in the Territory. The non-refundable up-front payment has been recorded as deferred revenue and will be recognized as revenue on a straight-line basis over the contractual term of the Agreement. The Company recognized $2,200 revenue related to the Wonik agreement for each of the three months ended September 30, 2016 and 2015. Deferred revenue short-term balance at September 30, 2016 and December 31, 2015 amounted to approximately $9,000 for each period and deferred revenue long-term balances at September 30, 2016 and December 31, 2015 amounted to approximately $22,000 and $29,000, 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, 2016 2015 Series C non-voting convertible preferred stock 2,865,000 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 4,006,468 4,422,188 Shares underlying outstanding stock options 4,637,255 3,689,545 Total 14,947,722 14,415,732 Stock-Based Compensation The Company accounts for stock options granted to employees, officers and directors according to ASC No. 718, “Compensation — Stock Compensation” The Company accounts for stock options granted to non-employees on a fair value basis using the Black-Scholes option pricing model in accordance with ASC 718 and ASC No. 505-50, “Equity-Based Payments to Non-Employees” Stock compensation expense is recognized by applying the expected forfeiture rate during the vesting period to the fair value of the award. The estimation of the number of stock awards that will ultimately vest requires judgment, and to the extent actual results or updated estimates differ from the Company’s current estimates, compensation expense may need to be revised. The Company considers many factors when estimating expected forfeitures for stock awards granted to employees, officers and directors, including types of awards, employee class, and an analysis of historical forfeitures. 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. 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.

3. Stockholders' Equity

3. Stockholders' Equity	9 Months Ended
	Sep. 30, 2016
STOCKHOLDERS' EQUITY
Stockholders' Equity	Common Stock The Company has entered into an At-the-Market Issuance Sales Agreement (the “Sales Agreement”) with MLV & Co. LLC, now a subsidiary of FBR & Co. (“MLV”), under which the Company may issue and sell up to $40.0 million of shares of its common stock from time to time through MLV acting as agent, subject to limitations imposed by the Company, such as the number or dollar amount of shares registered under the registration statement to which the offering relates. When the Company wishes to issue and sell common stock under the Sales Agreement, it notifies MLV of the number of shares to be issued, the dates on which such sales are anticipated to be made, any minimum price below which sales may not be made and other sales parameters as the Company deems appropriate. MLV is entitled to a commission of up to 3% of the gross proceeds from the sale of common stock sold under the Sales Agreement. The shares of common stock to be sold under the Sales Agreement are registered under an effective registration statement filed with the SEC. At September 30, 2016, approximately $4.1 million is available for sale under this Sales Agreement. During the nine months ended September 30, 2016, the Company issued 3,353,437 shares of common stock under the Sales Agreement and realized net proceeds of approximately $6.2 million. In August 2016, the Company entered into a new At Market Issuance Sales Agreement with FBR Capital Markets & Co. (“FBR”), the successor in interest to MLV, which is identical in terms to the Sales Agreement for the Company’s current ATM program and allows the Company to sell up to $40 million of shares of its common stock. The Company will not and cannot access the ATM program under the new sales agreement unless and until (i) the Company and Elliott Associates, L.P. ("Elliot") agree as to the exercise or waiver of Elliott's participation rights in the new ATM program, which rights were granted in a Consent and Exchange Agreement dated September 15, 2014, and apply to any equity financing we undertake until September 15, 2017, and (ii) the registration statement that includes the prospectus for the new ATM program that the Company filed with the Securities and Exchange Commission is declared effective. At that time, the Company will be able to access the new ATM program and will terminate the current ATM program and the related Sales Agreement. During the nine months ended September 30, 2016, the Company issued a total of 1,067,500 shares of common stock upon exercise of stock options resulting in gross proceeds of $849,501 to the Company. During the nine months ended September 30, 2016, the Company issued 21,454 shares of its common stock upon a cashless exercise of 25,000 warrants. Stock Options During the nine months ended September 30, 2016, the Company granted ten-year non-qualified stock options under the 2013 Stock Incentive Plan (the “2013 Plan”) covering an aggregate of 2,891,000 shares of the Company’s common stock to its officers, directors, employees and consultants. Of these options, 1,850,000 were granted on September 30, 2016 to the Company’s new CEO in connection with his employment. 1,250,000 of the options will vest in four equal annual installments on the first four anniversaries of the grant date. Of the remaining options, 300,000, split into three equal tranches, become exercisable upon the achievement of specified performance milestones, provided that these options will be forfeited if the milestones are not achieved within four years of grant date and provided further that these options will not vest before December 18, 2018. The remaining 300,000 options become exercisable upon the achievement of a specified average closing stock price, provided that these options will not vest before December 31, 2018 and if the closing price per share of the Company’s common stock is below the specified average closing stock price on December 31, 2018, the options will be forfeited. In each case, the new CEO must be an employee of the Company or consultant to the Company on the applicable vesting date. The total fair value of the 1,850,000 stock options issued to the Company’s CEO on the date of grant was $3,186,450 which will be amortized to expense over the related vesting periods beginning in the fourth quarter of 2016. During the three and nine months ended September 30, 2016, total compensation expense for stock options issued to employees, directors, officers and consultants was $192,685 and $920,864, respectively, and $921,153 and $2,908,855 for the three and nine months ended September 30, 2015, respectively. The fair value of the grants issued subject to service and performance based vesting conditions was determined using the Black-Scholes option pricing model with the following assumptions: Nine Months Ended September 30, 2016 Expected Term 5 – 10 years Volatility 96% - 98% Dividend yield 0.0% Risk-free interest rate 1.14% - 1.94% Weighted-average fair value of options granted during the period $ 1.76 The Company estimated the expected term of the stock options granted to employees 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. 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, 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 fair value of the grant issued, subject to a market based vesting condition, was determined using the Monte Carlo option pricing model which values financial instruments whose value is dependent on share price by sampling random paths for share price. The key inputs for the simulation included the closing stock price of the Company on the date of grant, the expected term of the stock options granted was based on anticipated exercises in future periods, the expected stock price volatility for the Company’s stock options was calculated based on the historical volatility since the initial public offering of the Company’s common stock in March 2010, weighted pre and post CE Mark, the expected dividend yield of 0.0% reflects the Company’s current and expected future policy for dividends on the Company’s common stock and the risk-free interest rate which was determined by utilizing 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 table below summarizes the key inputs used in the Monte Carlo simulation: Expected Term 5 years Volatility 97% Dividend yield 0.0% Risk-free interest rate 1.13% Weighted-average fair value of options granted during the period $ 1.12 A summary of the Company’s stock option activity and related information for the nine months ended September 30, 2016 is as follows: Shares Weighted Average Exercise Price Outstanding at beginning of period 3,600,045 $ 1.82 Exercised (1,067,500) $ 0.80 Forfeited (276,290) $ 2.27 Expired (510,000) $ 2.73 Granted 2,891,000 $ 2.38 Outstanding at end of period 4,637,255 $ 2.28 Options exercisable 2,011,583 $ 2.09 Weighted average remaining contractual life of stock options outstanding (years) 8.5 Weighted average remaining contractual life of stock options exercisable (years) 6.7 Weighted average vesting period over which total compensation expense related to non-vested options not yet recognized (years) 2.4 Compensation expense related to non-vested options not yet recognized $ 4,023,733 Aggregate intrinsic value of stock options exercised $ 1,466,589 Aggregate intrinsic value of stock options outstanding $ 2,124,291 The aggregate intrinsic value is calculated as the difference between the exercise prices of the underlying options and the quoted closing price of the common stock of the Company at the end of the reporting period for those options that have an exercise price below the quoted closing price. Warrants The following table is the summary of warrant activity for the nine months ended September 30, 2016: Shares Weighted Weighted Average Remaining Contractual Life Outstanding at beginning of period 4,422,188 $ 1.80 3.07 Expired (390,720 ) $ 3.44 — Exercised (25,000 ) $ 0.40 — Outstanding at end of period 4,006,468 $ 1.65 2.61

4. Related Party Transactions

4. Related Party Transactions	9 Months Ended
	Sep. 30, 2016
Related Party Transactions [Abstract]
Related Party Transactions	On March 3, 2015, the Company entered into a backstop agreement with an existing institutional investor, Manchester Securities Corp., a wholly owned subsidiary of Elliott Associates, L.P., and a beneficial holder of more than 5% of the Company’s outstanding common stock. Pursuant to the backstop agreement, Manchester had agreed to lend the Company, at its request, up to $4,500,000 less the dollar amount of gross proceeds received by the Company upon the exercise of warrants to purchase common stock issued in connection with its initial public offering, or IPO, on or before April 30, 2015, provided that the loan could not exceed $3,000,000. As a result of the backstop agreement, in March 2015, the Company issued five-year warrants exercisable for an aggregate of up to 283,400 common shares with an exercise price of $7.00 per share and recorded an expense of $1,583,000 for the value of these warrants. The backstop agreement was not accessed. Pursuant to the backstop agreement, 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. Manchester appointed one director in August 2015 and appointed another director in April 2016.

5. Commitments and Contingencie

5. Commitments and Contingencies	9 Months Ended
	Sep. 30, 2016
Commitments and Contingencies Disclosure [Abstract]
Commitments and Contingencies	Contingency Matters 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 NDP’s utility model DE 20 2005 022 124 U1 (the “Utility Model”), which the Company believes is fundamentally identical to the Prosl European Patent in its main aspects and claims. The Court separated the two proceedings and the Prosl European Patent and the Utility Model claims are now being tried separately. TauroPharm has filed a cancellation action against the Utility Model before the German Patent and Trademark Office (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-HEP100 TM TM The Court issued its decisions on May 8, 2015, staying both proceedings. In its decisions, the Court found that the commercialization by TauroPharm in Germany of its TauroLock catheter lock solutions Hep100 and Hep500 infringes both the Prosl European Patent and the Utility Model and further that there is no prior use right that would allow TauroPharm to continue to make, use or sell its product in Germany. However, the Court declined to issue an injunction in favor of the Company that would preclude the continued commercialization by TauroPharm based upon its finding that there is a sufficient likelihood that the EPO, in the case of the Prosl European Patent, or the German PTO, in the case of the Utility Model, may find that such patent or utility model is invalid. Specifically, the Court noted the possible publication of certain instructions for product use that may be deemed to constitute prior art. As such, the District Court determined that it will defer any consideration of the request by the Company for injunctive and other relief until such time as the EPO or the German PTO has 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. No date has yet been scheduled for such further hearing as of the filing of this Form 10-Q. 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 Company will submit a further writ pushing for a date for the oral hearing and bringing forward the Company’s counter-arguments. 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 of the validity and possible infringement of the Prosl European Patent by the EPO. 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 TauroLock TM In connection with the aforementioned patent and utility model infringement proceedings against TauroPharm, the Company was required by the District Court Mannheim to provide a security deposit of approximately $132,000 to cover legal fees in the event TauroPharm is entitled to reimbursement of these costs. The Company recorded the deposit as restricted cash for the 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. On July 7, 2015, a putative class action lawsuit was commenced against the Company and certain of its current and former officers in the United States District Court for the District of New Jersey, captioned Li v. Cormedix Inc., et al. On December 1, 2015, Lead Plaintiff filed an Amended Complaint asserting claims that the Company and Steven Lefkowitz, Randy Milby and Harry O’Grady (the “Cormedix Defendants”) violated Section 10(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and Rule 10b-5 promulgated thereunder and Section 20(a) of the Exchange Act. The Amended Complaint also names as defendants several unrelated entities that allegedly were paid stock promoters. Lead Plaintiff alleges generally that the Cormedix Defendants made materially false or misleading statements and omissions concerning, among other things, the competitive landscape for the Company’s Neutrolin product and the alleged use of stock promoters. The Amended Complaint seeks unspecified damages, interest, attorneys’ fees, and other costs. On February 1, 2016, the Cormedix Defendants filed a motion to dismiss all claims asserted against them in the Amended Complaint on the grounds, among others, that the Amended Complaint fails to adequately allege: (1) material misstatements or omissions; (2) scienter by any of the Cormedix Defendants; or (3) loss causation. The Court heard oral argument on this motion on July 18, 2016 in an order dated October 27, 2016, the Court granted the Cormedix Defendants’ Motion to Dismiss and dismissed with prejudice the Amended Complaint. On May 13, 2016, a putative shareholder derivative action was filed in the Superior Court of New Jersey against the Company and certain present and former directors and officers captioned Raval v. Milby, et. al. The Company believes that it has substantial legal and factual defenses to the claims in the Securities Class Action and the Derivative Action and intends to continue vigorously defending those cases. Commitments Manufacturing Navinta LLC, a U.S.-based API developer, has provided API manufacturing (manufactured in India at an FDA-compliant facility) and a Drug Master File for CRMD003, pursuant to an original supply agreement dated December 7, 2009 (the “Navinta Agreement”). The Company was required to make certain cash payments to Navinta upon the achievement of certain sales-based milestones which was based on a tiered approach and was not to commence until the Company achieves a designated net sales threshold. The maximum aggregate amount of such payments, assuming achievement of all milestones, would have been $1,975,000 over five years. There were no milestones achieved during the nine months ended September 30, 2016. On March 24, 2015, the Company and Navinta LLC entered into an amendment to the Navinta Agreement to extend the term of the Navinta Agreement to March 31, 2016 and to lower the price per kilogram of API that the Company purchases from Navinta LLC under the Navinta Agreement. The Company also agreed to purchase a minimum amount of product from Navinta LLC during 2015, which replaced the prior minimum purchase requirement. The Navinta Agreement expired on March 31, 2016 without delivery of the minimum purchase requirement. The Agreement will not be renewed and no further obligations for purchase nor milestone payments for sales exist. The Company has developed a program aimed at reducing the cost of goods of Neutrolin through a more efficient, custom synthesis of the active ingredient taurolidine. As part of that program, on April 8, 2015, the Company entered into a Preliminary Services Agreement with [RC] 2 The Company also has 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 $3.4 million. During the three and nine months ended September 30, 2016, the Company recognized research and development expense of approximately $777,000 and $1,510,000, respectively, related to these agreements. 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, CorMedix signed a Master Service Agreement and Work Order (the “Master Service Agreement”) with PPD Development, LP (“PPD”) for a $19.2 million Phase 3 multicenter, double-blind, randomized active control study (the “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. The Phase 3 Clinical Trial is expected to accrue up to 632 patients in approximately 70 sites in the U.S. During the three and nine months ended September 30, 2016, the Company recognized $1.8 million and $3.8 million research and development expense related to this agreement. In-Licensing In 2008, the Company entered into a License and Assignment Agreement (the “NDP License Agreement”) with NDP. Pursuant to the NDP License Agreement, NDP granted the Company exclusive, worldwide licenses for certain antimicrobial catheter lock solutions, processes for treating and inhibiting infections, a biocidal lock system and a taurolidine delivery apparatus, and the corresponding United States and foreign patents and applications (the “NDP Technology”). The Company acquired such licenses and patents through its assignment and assumption of NDP’s rights under certain separate license agreements by and between NDP and Dr. Hans-Dietrich Polaschegg, Dr. Klaus Sodemann and Dr. Johannes Reinmueller. As consideration in part for the rights to the NDP Technology, the Company paid NDP an initial licensing fee of $325,000 and granted NDP a 5% equity interest in the Company, consisting of 39,980 shares of the Company’s common stock. In addition, the Company is required to make payments to NDP upon the achievement of certain regulatory and sales-based milestones. Certain of the milestone payments are to be made in the form of shares of common stock currently held in escrow for NDP, and other milestone payments are to be paid in cash. The maximum aggregate number of shares issuable upon achievement of milestones is 145,543 shares. In 2014, a certain milestone was achieved resulting in the release of 36,386 shares held in escrow. The number of shares held in escrow as of September 30, 2016 is 109,157 shares of common stock. The maximum aggregate amount of cash payments upon achievement of milestones is $3,000,000 with $2,500,000 remaining at September 30, 2016. 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, 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. Other On September 27, 2016, the Company entered into an employment agreement, effective October 3, 2016, with Khoso Baluch, who joined the Company on October 3, 2016 as its Chief Executive Officer. Unless renewed pursuant to the terms thereof, the agreement will expire on October 3, 2019. After the initial threeyear term of Mr. Baluch’s employment agreement, the agreement will automatically renew for additional successive oneyear 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. Mr. Baluch also was appointed to the Company’s Board of Directors (the “Board”) on October 3, 2016. Mr. Baluch will receive an annual base salary of $375,000, which cannot be decreased unless all officers and/or members of the Company’s executive management team experience an equal or greater percentage reduction in total compensation and no reduction may be greater than 25%. Mr. Baluch will be eligible for an annual bonus, which may equal up to 80% of his base salary then in effect, as determined by the Board or compensation committee. If the Company terminates Mr. Baluch’s employment other than for Cause (as defined in the agreement), death or disability, other than by notice of nonrenewal, or if Mr. Baluch resigns for Good Reason (as defined in the agreement), Mr. Baluch will receive the following: (i) payment of any accrued compensation and any unpaid bonus for the prior year; (ii) his base salary and benefits for a period of 12 months following the effective date of the termination of his employment; (iii) payment on a prorated basis of any partial bonus earned based on the actual achievement of the specified bonus objectives; (iv) if elected continued health insurance coverage under COBRA, the Company will pay the premium to continue such coverage in an amount equal to the portion paid for by the Company during employment until the conclusion of the time when he is receiving continuation of base salary payments; and (v) all restricted shares and unvested stock options held by Mr. Baluch 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 3, 2015, the Company entered into a Release of Claims and Severance Modification with Randy Milby, its former Chief Executive Officer, that Mr. Milby may not compete against the Company by engaging in any business involving the development or commercialization of (i) a preventive anti-infective product that would be a direct competitor of Neutrolin or (ii) a product containing taurolidine. The non-compete term did not change and remains at twelve months following termination of his employment. The employment agreement was also amended to allow Mr. Milby a period in which to exercise all vested options and warrants until the later of 60 months following the termination date of his employment, provided in no event shall he be able to exercise after the respective expiration date of any stock option or warrant. During the quarter ended September 30, 2015, the Company recorded non-cash expense of $507,341 as a result of this modification. Mr. Milby resigned as the Company’s Interim Chief Executive Officer on October 2, 2016. Pursuant to the terms of his employment agreement, Mr. Milby will be entitled to receive his base salary and benefits for a period of twelve months following the effective date of the termination of his employment, or, in the case of benefits, until such time as he receives equivalent coverage and benefits under plans and programs of a subsequent employer if such receipt is prior to the expiration of the twelve month period. To the extent any of the aforementioned benefits cannot be provided to former employees, the Company will pay Mr. Milby a lump-sum payment in the amount necessary to allow Mr. Milby to purchase the equivalent benefits. The Company accrued $325,000 of severance pay during the year ended December 31, 2015 which remained unpaid at September 30, 2016. The Company entered into sublease for 4,700 square feet of office space in Bedminster, New Jersey, which sublease runs from April 1, 2015 until March 31, 2018. Rent is $5,000 per month plus occupancy costs such as utilities, maintenance and taxes. In accordance with the lease agreement, the Company has deposited $5,000 with the landlord, the equivalent of one month rent. The Company’s subsidiary entered into a lease agreement for its offices in Fulda, Germany. The lease has a term of 36 months which commenced on September 1, 2013 for a base monthly payment of €498. The total 36 month lease obligation is approximately €17,900 ($20,000). The 36 month lease has terminated and is renewable every three months commencing on November 1, 2016 for a base monthly payment of €461. Rent expense for the three and nine months ended September 30, 2016 was $17,000 and $51,000, respectively and $16,000 and $55,000 for the three and nine months ended September 30, 2015, respectively. Under the Company’s current lease agreements, the total remaining lease obligation as of September 30, 2016 is set forth below: 2017 $ 62,405 2018 30,000 Total $ 92,405

2. Summary of Significant Acc12

2. Summary of Significant Accounting Policies (Policies)	9 Months Ended
	Sep. 30, 2016
Accounting Policies [Abstract]
Liquidity and Going Concern	The Company’s operations are subject to a number of factors that can affect its operating results and financial condition. Such factors include, but are not limited to: the results of clinical testing and trial activities of the Company’s product candidates; the ability to obtain regulatory approval to market the Company’s products; ability to manufacture successfully; competition from products manufactured and sold or being developed by other companies; the price of, and demand for, Company products; the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products; and the Company’s ability to raise capital to support its operations. To date, the Company’s commercial operations have not generated enough revenues to enable profitability. As of September 30, 2016, the Company had an accumulated deficit of $112.6 million, and incurred losses from operations of $18.2 million and $9.1 million for the nine and three months then ended, respectively. Based on the 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 the Company’s other operating requirements, management believes that the existing cash at September 30, 2016 will not be sufficient to fund operations for at least the next twelve months following the balance sheet date. Additionally, the Company will need additional funding to complete the hemodialysis clinical trial in the U.S. which commenced in December 2015 as well as to initiate the planned Phase 3 clinical trial in oncology patients with catheters. At September 30, 2016, the Company had $4.1 million available under its current at-the-market program. In August 2016, the Company entered into a new sales agreement with the same bank to allow the Company to sell up to $40 million of shares of its common stock. The Company will not and cannot access the ATM program under the new sales agreement unless and until (i) the Company and Elliott Associates, L.P. ("Elliot") agree as to the exercise or waiver of Elliott's participation rights in the new ATM program, which rights were granted in a Consent and Exchange Agreement dated September 15, 2014, and apply to any equity financing we undertake until September 15, 2017, and (ii) the registration statement that includes the prospectus for the new ATM program that the Company filed with the Securities and Exchange Commission is declared effective. At such time, the Company will be able to access the new ATM program and will terminate the current ATM program and the related Sales Agreement. There is no assurance that conditions will allow the Company to raise additional funds available under its at-the-market program. The Company’s continued operations will ultimately depend on its ability to raise additional capital through various potential sources, such as equity and/or debt financings, strategic relationships, or out-licensing of its products in order to complete its ongoing and planned Phase 3 clinical trials and until it achieves profitability, if ever. The Company can provide no assurances that such financing or strategic relationships will be available on acceptable terms, or at all. Without this funding, the Company could be required to delay, scale back or eliminate some or all of its research and development programs which would likely have a material adverse effect on the Company’s business.
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.
Cash and Cash Equivalents	Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents. The Company maintains its cash and cash equivalents in bank deposits and other interest bearing accounts, the balances of which exceed federally insured limits.
Short term investments	Short-Term Investments The Company determines the appropriate classification of marketable securities at the time of purchase and reevaluates such designation as of each balance sheet date. Investments in marketable debt and equity securities classified as available-for-sale are reported at fair value. Fair values of the Company’s investments are determined using quoted market prices in active markets for identical assets or liabilities or quoted prices for similar assets or liabilities or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Changes in fair value that are considered temporary are reported net of tax in other comprehensive income (loss). Realized gains and losses, amortization of premiums and discounts and interest and dividends earned are included in income (expense) on the condensed consolidated statements of operations and comprehensive income (loss). The cost of investments for purposes of computing realized and unrealized gains and losses is based on the specific identification method. For declines in the fair value of equity securities that are considered other-than-temporary, impairment losses are charged to other (income) expense, net. The Company considers available evidence in evaluating potential impairments of its investments, including the duration and extent to which fair value is less than cost. There were no deemed permanent impairments at September 30, 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, 2016, all of the Company’s investments had contractual maturities which were less than one year. The following table summarizes the amortized cost, unrealized gains and losses and the fair value at September 30, 2016 and December 31, 2015 of the Company’s financial assets that are measured on a recurring basis: September 30, 2016: Amortized Cost Gross Unrealized Losses Gross Unrealized Gains Fair Value Money Market Funds included in Cash Equivalents $ 3,310,359 $ - $ - $ 3,310,359 U.S. Government Agency Securities 3,211,974 - 567 3,212,541 Corporate Securities 12,131,193 (7,688) 114 12,123,619 Commercial Paper 1,490,552 - - 1,490,552 Subtotal 16,833,719 (7,688) 681 16,826,712 Total September 30, 2016 $ 20,144,078 $ (7,688) $ 681 $ 20,137,071 December 31, 2015: Money Market Funds included in Cash Equivalents $ 3,353,067 $ - $ - $ 3,353,067 U.S. Government Agency Securities 6,531,914 (3,014) - 6,528,900 Corporate Securities 15,065,595 (21,637) 412 15,044,370 Commercial Paper 1,995,116 - - 1,995,116 Subtotal 23,592,625 (24,651) 412 23,568,386 Total December 31, 2015 $ 26,945,692 $ (24,651) $ 412 $ 26,921,453
Fair value measurements	The Company’s financial instruments recorded in the consolidated balance sheets include cash and cash equivalents, accounts receivable, investment securities, accounts payable and accrued expenses. The carrying value of certain financial instruments, primarily cash and cash equivalents, accounts receivable, accounts payable, and accrued expenses approximate their estimated fair values based upon the short-term nature of their maturity dates. The Company categorizes its financial instruments into a three-level fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets (Level 1) and the lowest priority to unobservable inputs (Level 3). If the inputs used to measure fair value fall within different levels of the hierarchy, the category level is based on the lowest priority level input that is significant to the fair value measurement of the instrument. Financial assets recorded at fair value on the Company’s condensed consolidated balance sheets are categorized as follows: • Level 1 inputs—Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets. • Level 2 inputs— Significant other observable inputs (e.g., quoted prices for similar items in active markets, quoted prices for identical or similar items in markets that are not active, inputs other than quoted prices that are observable such as interest rate and yield curves, and market-corroborated inputs). • Level 3 inputs—Unobservable inputs for the asset or liability, which are supported by little or no market activity and are valued based on management’s estimates of assumptions that market participants would use in pricing the asset or liability. 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, 2016 and December 31, 2015: September 30, 2016: Carrying Value Level 1 Level 2 Level 3 Money Market Funds $ 3,310,359 $ 3,310,359 $ - $ - US Government Agency Securities 3,212,541 - 3,212,541 - Corporate Securities 12,123,619 - 12,123,619 - Commercial Paper 1,490,552 - 1,490,552 - Subtotal 16,826,712 - 16,826,712 $ - Total September 30, 2016 $ 20,137,071 $ 3,310,359 $ 16,826,712 $ - December 31, 2015: Money Market Funds $ 3,353,067 $ 3,353,067 $ - $ - US Government Agency Securities 6,528,900 - 6,528,900 - Corporate Securities 15,044,370 - 15,044,370 - Commercial Paper 1,995,116 - 1,995,116 - Subtotal 23,568,386 - 23,568,386 $ - Total December 31, 2015 $ 26,921,453 $ 3,353,067 $ 23,568,386 $ -
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 income (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, 2016 and December 31, 2015, 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 and Other Prepaid Expenses	Prepaid expenses consist of payments made in advance to vendors relating to service contracts for clinical trial development, manufacturing, preclinical development and insurance policies. These advanced payments are amortized to expense either as services are performed or over the relevant service period using the straight-line method.
Inventories, net	Inventories are valued at the lower of cost or market on a first in, first out basis. Inventories consist of raw materials (including labeling and packaging), work-in-process, and finished goods for the Neutrolin product. Inventories consist of the following: September 30, 2016 December 31, 2015 Raw materials $ 221,355 $ 244,459 Work in process 355,297 424,622 Finished goods 7,555 7,488 Inventory reserve (466,000) (300,000) Total $ 118,207 $ 376,569
Accrued Expenses	Accrued expenses consist of the following: September 30, 2016 December 31, 2015 Professional and consulting fees $ 333,982 $ 282,975 Accrued payroll and payroll taxes 722,823 532,084 Clinical trial and manufacturing development 1,763,889 226,042 Product development 285,915 - Monitoring program fees 20,963 65,076 Statutory taxes 3,307 67,236 Other 18,847 48,144 Total $ 3,149,726 $ 1,221,557
Revenue Recognition	The Company recognizes revenue in accordance with SEC Staff Accounting Bulletin (“SAB”) Topic 13, Revenue Recognition Revenue Recognition .
Deferred Revenue	In October 2015, the Company shipped product with less than 75% of its remaining shelf life to an international distributor 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. As a result of this warranty, the Company may have an additional performance obligation (i.e. accept returned product and deliver new product to the customer) if the customer is unable to sell such product. Due to limited sales experience with the customer, the Company is unable to estimate the amount of the warranty obligation that may be incurred as a result of this shipment. Therefore, the Company has deferred the revenue and related cost of sales associated with the shipment of this product. Since the Company will be unable to resell the expired product if returned by the customer, the deferred revenue and related cost of sales is presented net as Deferred Revenue on the condensed consolidated balance sheet which amounted to approximately $122,000 and $121,000 at September 30, 2016 and December 31, 2015, respectively. During the quarter ended September 30, 2016, the Company recognized $2,400 of revenue net of related cost of sales for this shipment. Additionally, the change in the exchange rate resulted in an increase in the Deferred Revenue balance of $3,000 during the quarter ended September 30, 2106. In August 2014, the Company entered into an exclusive distribution agreement (the “Wonik Agreement”) with Wonik Corporation, a South Korean company, to market, sell and distribute Neutrolin for hemodialysis and oncolytic patients upon receipt of regulatory approval in Korea. Upon execution of the Wonik Agreement, Wonik paid the Company a non-refundable $50,000 payment and will pay an additional $50,000 upon receipt of the product registration necessary to sell Neutrolin in the Republic of Korea (the “Territory”). The term of the Wonik Agreement commenced on August 8, 2014 and will continue for three years after the first commercial sale of Neutrolin in the Territory. The non-refundable up-front payment has been recorded as deferred revenue and will be recognized as revenue on a straight-line basis over the contractual term of the Agreement. The Company recognized $2,200 revenue related to the Wonik agreement for each of the three months ended September 30, 2016 and 2015. Deferred revenue short-term balance at September 30, 2016 and December 31, 2015 amounted to approximately $9,000 for each period and deferred revenue long-term balances at September 30, 2016 and December 31, 2015 amounted to approximately $22,000 and $29,000, 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, 2016 2015 Series C non-voting convertible preferred stock 2,865,000 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 4,006,468 4,422,188 Shares underlying outstanding stock options 4,637,255 3,689,545 Total 14,947,722 14,415,732
Stock-Based Compensation	The Company accounts for stock options granted to employees, officers and directors according to ASC No. 718, “Compensation — Stock Compensation” The Company accounts for stock options granted to non-employees on a fair value basis using the Black-Scholes option pricing model in accordance with ASC 718 and ASC No. 505-50, “Equity-Based Payments to Non-Employees” Stock compensation expense is recognized by applying the expected forfeiture rate during the vesting period to the fair value of the award. The estimation of the number of stock awards that will ultimately vest requires judgment, and to the extent actual results or updated estimates differ from the Company’s current estimates, compensation expense may need to be revised. The Company considers many factors when estimating expected forfeitures for stock awards granted to employees, officers and directors, including types of awards, employee class, and an analysis of historical forfeitures.
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. 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.

2. Summary of Significant Acc13

2. Summary of Significant Accounting Policies (Tables)	9 Months Ended
	Sep. 30, 2016
Accounting Policies [Abstract]
Summary of short-term investments	September 30, 2016: Amortized Cost Gross Unrealized Losses Gross Unrealized Gains Fair Value Money Market Funds included in Cash Equivalents $ 3,310,359 $ - $ - $ 3,310,359 U.S. Government Agency Securities 3,211,974 - 567 3,212,541 Corporate Securities 12,131,193 (7,688) 114 12,123,619 Commercial Paper 1,490,552 - - 1,490,552 Subtotal 16,833,719 (7,688) 681 16,826,712 Total September 30, 2016 $ 20,144,078 $ (7,688) $ 681 $ 20,137,071 December 31, 2015: Money Market Funds included in Cash Equivalents $ 3,353,067 $ - $ - $ 3,353,067 U.S. Government Agency Securities 6,531,914 (3,014) - 6,528,900 Corporate Securities 15,065,595 (21,637) 412 15,044,370 Commercial Paper 1,995,116 - - 1,995,116 Subtotal 23,592,625 (24,651) 412 23,568,386 Total December 31, 2015 $ 26,945,692 $ (24,651) $ 412 $ 26,921,453
Carrying and fair value of financial assets	September 30, 2016: Carrying Value Level 1 Level 2 Level 3 Money Market Funds $ 3,310,359 $ 3,310,359 $ - $ - US Government Agency Securities 3,212,541 - 3,212,541 - Corporate Securities 12,123,619 - 12,123,619 - Commercial Paper 1,490,552 - 1,490,552 - Subtotal 16,826,712 - 16,826,712 $ - Total September 30, 2016 $ 20,137,071 $ 3,310,359 $ 16,826,712 $ - December 31, 2015: Money Market Funds $ 3,353,067 $ 3,353,067 $ - $ - US Government Agency Securities 6,528,900 - 6,528,900 - Corporate Securities 15,044,370 - 15,044,370 - Commercial Paper 1,995,116 - 1,995,116 - Subtotal 23,568,386 - 23,568,386 $ - Total December 31, 2015 $ 26,921,453 $ 3,353,067 $ 23,568,386 $ -
Schedule of inventories	September 30, 2016 December 31, 2015 Raw materials $ 221,355 $ 244,459 Work in process 355,297 424,622 Finished goods 7,555 7,488 Inventory reserve (466,000) (300,000) Total $ 118,207 $ 376,569
Schedule of accrued expenses	September 30, 2016 December 31, 2015 Professional and consulting fees $ 333,982 $ 282,975 Accrued payroll and payroll taxes 722,823 532,084 Clinical trial and manufacturing development 1,763,889 226,042 Product development 285,915 - Monitoring program fees 20,963 65,076 Statutory taxes 3,307 67,236 Other 18,847 48,144 Total $ 3,149,726 $ 1,221,557
Schedule of anti-dilutive securities excluded from calculation of diluted net loss per share	Nine Months Ended September 30, 2016 2015 Series C non-voting convertible preferred stock 2,865,000 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 4,006,468 4,422,188 Shares underlying outstanding stock options 4,637,255 3,689,545 Total 14,947,722 14,415,732

3. Stockholders' Equity (Tables

3. Stockholders' Equity (Tables)	9 Months Ended
	Sep. 30, 2016
Stock options
Fair value assumptions for Black Sholes	Nine Months Ended September 30, 2016 Expected Term 5 – 10 years Volatility 96% - 98% Dividend yield 0.0% Risk-free interest rate 1.14% - 1.94% Weighted-average fair value of options granted during the period $ 1.76 Expected Term 5 years Volatility 97% Dividend yield 0.0% Risk-free interest rate 1.13% Weighted-average fair value of options granted during the period $ 1.12
Key inputs used in Monte Carlo simluation	Expected Term 5 years Volatility 97% Dividend yield 0.0% Risk-free interest rate 1.13% Weighted-average fair value of options granted during the period $ 1.12
Summary of Option Activity under Plan and Related Information	Shares Weighted Average Outstanding at beginning of period 3,600,045 $ 1.82 Exercised (1,067,500) $ 0.80 Forfeited (276,290) $ 2.27 Expired (510,000) $ 2.73 Granted 2,891,000 $ 2.38 Outstanding at end of period 4,637,255 $ 2.28 Options exercisable 2,011,583 $ 2.09 Weighted average remaining contractual life of stock options outstanding (years) 8.5 Weighted average remaining contractual life of stock options exercisable (years) 6.7 Weighted average vesting period over which total compensation expense related to non-vested options not yet recognized (years) 2.4 Compensation expense related to non-vested options not yet recognized $ 4,023,733 Aggregate intrinsic value of stock options exercised $ 1,466,589 Aggregate intrinsic value of stock options outstanding $ 2,124,291
Warrants
Summary of Warrant Activity	Shares Weighted Weighted Average Remaining Contractual Life Outstanding at beginning of period 4,422,188 $ 1.80 3.07 Expired (390,720 ) $ 3.44 — Exercised (25,000 ) $ 0.40 — Outstanding at end of period 4,006,468 $ 1.65 2.61

5. Commitments and Contingenc15

5. Commitments and Contingencies (Tables)	9 Months Ended
	Sep. 30, 2016
Commitments and Contingencies Disclosure [Abstract]
Schedule of Future Minimum Rental Payments for Operating Leases	2017 $ 62,405 2018 30,000 Total $ 92,405

2. Summary of Significant Acc16

2. Summary of Significant Accounting Policies (Details) - USD ($)	9 Months Ended	12 Months Ended
	Sep. 30, 2016	Dec. 31, 2015
Amortized cost	$ 20,144,078	$ 26,945,692
Gross unrealized losses	(7,688)	(24,651)
Gross unrealized gains	681	412
Fair value	20,137,071	26,921,453
Money Market Funds included in Cash Equivalents
Amortized cost	3,310,359	3,353,067
Gross unrealized losses	0	0
Gross unrealized gains	0	0
Fair value	3,310,359	3,353,067
U.S. Government Agency Securities
Amortized cost	3,211,974	6,531,914
Gross unrealized losses	0	(3,014)
Gross unrealized gains	567	0
Fair value	3,212,541	6,528,900
Corporate Securities
Amortized cost	12,131,193	15,065,595
Gross unrealized losses	(7,688)	(21,637)
Gross unrealized gains	114	412
Fair value	12,123,619	15,044,370
Commercial Paper
Amortized cost	1,490,552	1,995,116
Gross unrealized losses	0	0
Gross unrealized gains	0	0
Fair value	1,490,552	1,995,116
Subtotal
Amortized cost	16,833,719	23,592,625
Gross unrealized losses	(7,688)	(24,651)
Gross unrealized gains	681	412
Fair value	$ 16,826,712	$ 23,568,386

2. Summary of Significant Acc17

2. Summary of Significant Accounting Policies (Details 1) - USD ($)	Sep. 30, 2016	Dec. 31, 2015
Carrying Value	$ 20,137,071	$ 26,921,453
Level 1
Carrying Value	3,310,359	3,353,067
Level 2
Carrying Value	16,826,712	23,568,386
Level 3
Carrying Value	0	0
Money Market Funds included in Cash Equivalents
Carrying Value	3,310,359	3,353,067
Money Market Funds included in Cash Equivalents | Level 1
Carrying Value	3,310,359	3,353,067
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 Agency Securities
Carrying Value	3,212,541	6,528,900
U.S. Government Agency Securities | Level 1
Carrying Value		0
U.S. Government Agency Securities | Level 2
Carrying Value	3,212,541	6,528,900
U.S. Government Agency Securities | Level 3
Carrying Value		0
Corporate Securities
Carrying Value	12,123,619	15,044,370
Corporate Securities | Level 1
Carrying Value		0
Corporate Securities | Level 2
Carrying Value	12,123,619	15,044,370
Corporate Securities | Level 3
Carrying Value		0
Commercial Paper
Carrying Value	1,490,552	1,995,116
Commercial Paper | Level 1
Carrying Value		0
Commercial Paper | Level 2
Carrying Value	1,490,552	1,995,116
Commercial Paper | Level 3
Carrying Value		0
Subtotal
Carrying Value	16,826,712	23,568,386
Subtotal | Level 1
Carrying Value		0
Subtotal | Level 2
Carrying Value	$ 16,826,712	23,568,386
Subtotal | Level 3
Carrying Value		$ 0

2. Summary of Significant Acc18

2. Summary of Significant Accounting Policies (Details 2) - USD ($)	Sep. 30, 2016	Dec. 31, 2015
Summary Of Significant Accounting Policies Details 2
Raw materials	$ 221,355	$ 244,459
Work in process	355,297	424,622
Finished goods	7,555	7,488
Inventory reserve	(466,000)	(300,000)
Total	$ 118,207	$ 376,569

2. Summary of Significant Acc19

2. Summary of Significant Accounting Policies (Details 3) - USD ($)	Sep. 30, 2016	Dec. 31, 2015
Accounting Policies [Abstract]
Professional and consulting fees	$ 333,982	$ 282,975
Accrued payroll and payroll taxes	722,823	532,084
Clinical trial and manufacturing development	1,763,889	226,042
Product development	285,915	0
Monitoring program fees	20,963	65,076
Statutory taxes	3,307	67,236
Other	18,847	48,144
Total	$ 3,149,726	$ 1,221,557

2. Summary of Significant Acc20

2. Summary of Significant Accounting Policies (Details 4) - shares	9 Months Ended
	Sep. 30, 2016	Sep. 30, 2015
Antidilutive Shares	14,947,722	14,415,732
Series C non-voting convertible preferred stock
Antidilutive Shares	2,865,000	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	4,006,468	4,422,188
Shares underlying outstanding stock options
Antidilutive Shares	4,637,255	3,689,545

3. Stockholders' Equity (Detail

3. Stockholders' Equity (Details)	9 Months Ended
	Sep. 30, 2016$ / shares
Stock options
Expected Term, minimum	5 years
Expected Term, maximum	10 years
Volatility, minimum	96.00%
Volatility, maximum	98.00%
Dividend yield	0.00%
Risk-free interest rate, minimum	1.14%
Risk-free interest rate, maximum	1.94%
Weighted-average fair value of options granted during the period	$ 1.76
Monte Carlo
Expected Term	5 years
Volatility	97.00%
Dividend yield	0.00%
Risk-free interest rate	1.13%
Weighted-average fair value of options granted during the period	$ 1.12

3. Stockholders' Equity (Deta22

3. Stockholders' Equity (Details 1) - Stock options	9 Months Ended
	Sep. 30, 2016USD ($)$ / sharesshares
Number of Options
Outstanding at beginning of period | shares	3,600,045
Number of Options Exercised | shares	(1,067,500)
Number of Options Forfeited | shares	(276,290)
Number of Options Expired | shares	(510,000)
Number of Options Granted | shares	2,891,000
Outstanding at end of period | shares	4,637,255
Options exercisable | shares	2,011,583
Weighted Average Exercise Price
Weighted Average Exercise Price Outstanding, Beginning	$ 1.82
Weighted Average Exercise Price Exercised	0.80
Weighted Average Exercise Price Forfeited	2.27
Weighted Average Exercise Price Expired	2.73
Weighted Average Exercise Price Granted	2.38
Weighted Average Exercise Price Outstanding, Ending	2.28
Weighted Average Exercise Price Exercisable	2.09
Weighted-average fair value of options granted during the period	1.76
Weighted-average fair value of options granted during the period, Monte Carlo valuation	$ 1.12
Weighted Average Remaining Contractual Life (in years)
Weighted Average Remaining Contractual Life (in years) Outstanding, Ending	8 years 6 months
Weighted Average Remaining Contractual Life (in years) Exercisable	6 years 8 months 12 days
Weighted average vesting period over which total compensation expense related to non-vested options not yet recognized (years)	2 years 4 months 24 days
Aggregate Intrinsic Value
Compensation expense related to non-vested options not yet recognized | $	$ 4,023,733
Aggregate intrinsic value of stock options exercised | $	1,466,589
Aggregate intrinsic value of stock options outstanding | $	$ 2,124,291

3. Stockholders' Equity (Deta23

3. Stockholders' Equity (Details 2) - Warrants	9 Months Ended
	Sep. 30, 2016$ / sharesshares
Outstanding at beginning of period | shares	4,422,188
Number of Warrants Expired | shares	(390,720)
Number of Warrants Exercised | shares	(25,000)
Outstanding at end of period | shares	4,006,468
Weighted Average Exercise Price Outstanding, Beginning | $ / shares	$ 1.80
Weighted Average Exercise Price Expired | $ / shares	3.44
Weighted Average Exercise Price Exercised | $ / shares	0.40
Weighted Average Exercise Price Outstanding, Ending | $ / shares	$ 1.65
Weighted Average Remaining Contractual Life (in years) Outstanding, Beginning	3 years 25 days
Weighted Average Remaining Contractual Life (in years) Outstanding, Ending	2 years 7 months 10 days

5. Commitments and Contingenc24

5. Commitments and Contingencies (Details)	Sep. 30, 2016USD ($)
Commitments And Contingencies Details
2,017	$ 62,405
2,018	30,000
Total	$ 92,405