CorMedix (CRMD) 10-Q 10 May 17 2017 Q1 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	3 Months Ended
	Mar. 31, 2017	May 08, 2017
Document And Entity Information
Entity Registrant Name	CorMedix Inc.
Entity Central Index Key	1,410,098
Document Type	10-Q
Document Period End Date	Mar. 31, 2017
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Is Entity a Well-known Seasoned Issuer?	No
Is Entity a Voluntary Filer?	No
Is Entity's Reporting Status Current?	Yes
Entity Filer Category	Accelerated Filer
Entity Common Stock, Shares Outstanding		59,340,139
Document Fiscal Period Focus	Q1
Document Fiscal Year Focus	2,017

CONDENSED CONSOLIDATED BALANCE

CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($)	Mar. 31, 2017	Dec. 31, 2016
Current assets
Cash and cash equivalents	$ 6,818,668	$ 8,064,490
Restricted cash	171,553	171,553
Short-term investments	6,950,960	12,100,920
Trade receivables	75,879	12,014
Inventories, net	94,867	166,733
Prepaid research and development expenses	529,735	943,924
Other prepaid expenses and current assets	223,339	372,057
Total current assets	14,865,001	21,831,691
Property and equipment, net	63,151	69,695
Security deposit	5,000	5,000
TOTAL ASSETS	14,933,152	21,906,386
Current liabilities
Accounts payable	1,726,483	1,645,298
Accrued expenses	2,062,969	2,342,352
Deferred revenue	100,511	104,210
Total current liabilities	3,889,963	4,091,860
TOTAL LIABILITIES	3,889,963	4,091,860
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS' EQUITY
Preferred stock - $0.001 par value: 2,000,000 shares authorized; 442,585 and 450,085 shares issued and outstanding at March 31, 2017 and December 31, 2016, respectively	443	450
Common stock - $0.001 par value: 80,000,000 shares authorized; 40,720,838 and 40,432,339 shares issued and outstanding at March 31, 2017 and December 31, 2016, respectively	40,721	40,433
Accumulated other comprehensive income	90,307	81,186
Additional paid-in capital	137,673,530	136,857,409
Accumulated deficit	(126,761,812)	(119,164,952)
TOTAL STOCKHOLDERS' EQUITY	11,043,189	17,814,526
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$ 14,933,152	$ 21,906,386

CONDENSED CONSOLIDATED BALANCE3

CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares	Mar. 31, 2017	Dec. 31, 2016
Statement of Financial Position [Abstract]
Preferred stock, par value	$ 0.001	$ 0.001
Preferred stock, shares authorized	2,000,000	2,000,000
Preferred stock, shares issued	442,585	450,085
Preferred stock, shares outstanding	442,585	450,085
Common stock, par value	$ 0.001	$ 0.001
Common stock, shares authorized	80,000,000	80,000,000
Common stock, shares issued	40,720,838	40,432,339
Common stock, shares outstanding	40,720,838	40,432,339

CONDENSED CONSOLIDATED STATEMEN

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE GAIN (LOSS) - USD ($)	3 Months Ended
	Mar. 31, 2017	Mar. 31, 2016
Revenue
Net sales	$ 39,559	$ 41,427
Cost of sales	(93,571)	(50,229)
Gross profit (loss)	(54,012)	(8,802)
Operating Expenses
Research and development	(4,924,267)	(2,089,592)
Selling, general and administrative	(2,640,726)	(2,050,143)
Total operating expenses	(7,564,993)	(4,139,735)
Loss From Operations	(7,619,005)	(4,148,537)
Other Income (Expense)
Interest income	23,431	31,636
Foreign exchange transaction gain (loss)	(1,286)	(487)
Interest expense	0	(992)
Total income (expense)	22,145	30,157
Net Loss	(7,596,860)	(4,118,380)
Other Comprehensive Income Gain (Loss)
Unrealized gain (loss) from investment	10,113	(793)
Foreign currency translation gain (loss)	(992)	31,645
Total comprehensive income	9,121	30,852
Comprehensive Loss	$ (7,587,739)	$ (4,087,528)
Net Loss Per Common Share - Basic and Diluted	$ (0.19)	$ (0.11)
Weighted Average Common Shares Outstanding - Basic and Diluted	40,624,920	36,012,756

CONDENSED CONSOLIDATED STATEME5

CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS' EQUITY - 3 months ended Mar. 31, 2017 - USD ($)	Common Stock	Non-Voting Preferred Stock - Series C-2, Series C-3, Series D and Series E	Accumulated Other Comprehensive Income	Additional Paid-In Capital	Accumulated Deficit	Total
Beginning balance, Shares at Dec. 31, 2016	40,432,339	450,085
Beginning balance, Amount at Dec. 31, 2016	$ 40,433	$ 450	$ 81,186	$ 136,857,409	$ (119,164,952)	$ 17,814,526
Stock issued in connection with sale of common stock, net, Shares	198,630
Stock issued in connection with sale of common stock, net, Amount	$ 198			347,163		347,361
Stock issued in connection with stock options exercised, Shares	10,000
Stock issued in connection with stock options exercised, Amount	$ 10			6,790		6,800
Conversion of Series C3 non-voting preferred stock to common stock, Shares	75,000	(7,500)
Conversion of Series C3 non-voting preferred stock to common stock, Amount	$ 75	$ (7)		(68)		0
Stock issued for payment of deferred fees, Shares	4,869
Stock issued for payment of deferred fees, Amount	$ 5			10,213		10,218
Stock-based compensation				452,023		452,023
Other comprehensive income			9,121			9,121
Net loss					(7,596,860)	(7,596,860)
Ending balance, Shares at Mar. 31, 2017	40,720,838	442,585
Ending balance, Amount at Mar. 31, 2017	$ 40,721	$ 443	$ 90,307	$ 137,673,530	$ (126,761,812)	$ 11,043,189

CONDENSED CONSOLIDATED STATEME6

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($)	3 Months Ended
	Mar. 31, 2017	Mar. 31, 2016
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$ (7,596,860)	$ (4,118,380)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation	452,023	329,276
Loss on foreign currency transactions	210	0
Inventory reserve	0	22,428
Depreciation	8,773	4,072
Changes in operating assets and liabilities:
Trade receivables	(63,509)	(15,498)
Inventory	71,866	20,268
Prepaid expenses and other current assets	563,180	(1,679,728)
Accounts payable	80,764	(130,207)
Accrued expenses	(270,292)	119,437
Deferred revenue	(4,881)	(2,256)
Net cash used in operating activities	(6,758,726)	(5,450,588)
CASH FLOWS FROM INVESTING ACTIVITIES:
Sale of short-term investments	5,160,073	6,547,842
Purchase of equipment	(1,998)	0
Net cash provided by investing activities	5,158,075	6,547,842
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from sale of common stock from an at-the-market program, net	347,361	149,276
Proceeds from exercise of warrants	6,800	116,700
Net cash provided by financing activities	354,161	265,976
Foreign exchange effect on cash	668	4,128
NET INCREASE (DECREASE) IN CASH	(1,245,822)	1,367,358
CASH - BEGINNING OF PERIOD	8,064,490	11,817,418
CASH - END OF PERIOD	6,818,668	13,184,776
Cash paid for interest	0	992
Supplemental Disclosure of Non-Cash Financing Activities:
Conversion of preferred stock to common stock	7	0
Issuance of common stock for payment of deferred fees	10,218	0
Unrealized gain (loss) from investments	$ (10,113)	$ (793)

1. Organization, Business and B

1. Organization, Business and Basis of Presentation	3 Months Ended
	Mar. 31, 2017
Organization Business And Basis Of Presentation
Organization, Business and Basis of Presentation	Organization and Business CorMedix Inc. (“CorMedix” or the “Company”), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases, was incorporated in the State of Delaware on July 28, 2006. In 2013, the Company formed a wholly-owned subsidiary, CorMedix Europe GmbH. The Company’s primary focus is to develop its lead product candidate, CRMD003 (also known as Neutrolin®), for potential commercialization in the United States (“U.S.”) and other key markets. The Company has in-licensed the worldwide rights to develop and commercialize Neutrolin, which is a novel anti-infective solution (a formulation of taurolidine, citrate and heparin 1000 u/ml) under development for the reduction and prevention of catheter-related infections and thrombosis in patients requiring central venous catheters in clinical settings such as dialysis, critical/intensive care, and oncology. The Company launched its 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 completion of this trial is subject to funding requirements. The Company also is in discussions with the FDA to develop the design of a Phase 3 clinical trial in oncology patients with catheters, or LOCK-IT-200. This trial also is subject to funding requirements. 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 is being sold in certain European Union and Middle Eastern countries. Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and with the instructions for Form 10-Q and Article 10 of Regulation S-X. Accordingly, the unaudited condensed consolidated financial statements do not include all information and footnotes required by GAAP for complete annual financial statements. In the opinion of management, the accompanying unaudited condensed consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation of such interim results. Interim operating results are not necessarily indicative of results that may be expected for the full year ending December 31, 2017 or for any subsequent period. These unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto of the Company which are included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 16, 2017. The accompanying condensed balance sheet as of December 31, 2016 has been derived from the audited financial statements included in such Form 10-K. Recently Adopted Accounting Pronouncements In July 2015, the Financial Accounting Standards Board (“FASB”) issued an accounting standard that requires that inventory be measured at the lower of cost and net realizable value and options that currently exist for market value be eliminated. The standard defines net realizable value as estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation and is effective for reporting periods beginning after December 15, 2016 and interim periods within those fiscal years with early adoption permitted. The guidance should be applied prospectively. The Company adopted this guidance as of January 1, 2017. The adoption of this guidance did not have a material impact on the Company’s consolidated financial statements. In November 2015, the FASB issued guidance that requires that deferred tax liabilities and assets be classified as noncurrent in a classified statement of financial position. The current requirement that deferred tax liabilities and assets of a tax-paying component of an entity be offset and presented as a single amount is not affected by this amendment. The new guidance is effective for fiscal years, and interim periods within those years, beginning after December 15, 2016. Early adoption is permitted and the standard may be applied either retrospectively or on a prospective basis to all deferred tax assets and liabilities. The Company adopted this guidance as of January 1, 2017. The adoption of this guidance did not have a material impact on the Company’s consolidated financial statements.

2. Summary of Significant Accou

2. Summary of Significant Accounting Policies	3 Months Ended
	Mar. 31, 2017
Accounting Policies [Abstract]
Summary of Significant Accounting Policies	Liquidity, Going Concern and Uncertainties The Company’s operations are subject to a number of factors that can affect its operating results and financial condition. Such factors include, but are not limited to: the Company’s ability to raise capital to support its operations; the results of clinical testing and trial activities of the Company’s product candidates; the ability to obtain regulatory approval to market the Company’s products; competition from products manufactured and sold or being developed by other companies; the price of, and demand for, Company products; the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products. The financial statements have been prepared in conformity with GAAP which contemplate continuation of the Company as a going concern. To date, the Company’s commercial operations have not generated sufficient revenues to enable profitability. As of March 31, 2017, the Company had an accumulated deficit of $126.8 million, and had incurred losses from operations of $7.6 million for the quarter then ended. 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 March 31, 2017, even after giving effect to the proceeds that the Company received from the equity financing that closed on May 3, 2017 (see Note 7), will not be sufficient to fund operations for at least the next twelve months following the filing of the Company’s report on Form 10-Q for the quarter ended March 31, 2017. These factors raise substantial doubt regarding the Company’s ability to continue as a going concern. At March 31, 2017, approximately $3.7 million remained available for sale under an April 2015 AttheMarket Issuance Sales Agreement (the “Current ATM program”) with MLV & Co. LLC (“MLV”), now a subsidiary of FBR Capital Markets & Co. (“FBR”), pursuant to which the Company is able to issue and sell up to $40 million of shares of its common stock from time to time. At March 31, 2017, the Company also had $60.0 million available under its current shelf registration for the issuance of equity, debt or equitylinked securities unrelated to the Current ATM program. The sale of any equity securities under this portion of the shelf registration statement is subject to participation rights held by Machester Securities Corp. ("Manchester") pursuant to which Manchester must either be offered 60% participation in such equity financing or the Company must obtain a waiver from Manchester. On May 3, 2017, the Company closed on an equity financing which raised net proceeds of approximately $12.8 million (see Note 7). In August 2016, the Company entered into a new sales agreement with FBR whereby the Company can sell up to $40 million of shares of its common stock (the “Pending ATM Program”), but only if the Company obtains a waiver from Manchester of its participation rights and the pending registration statement covering the Pending ATM Program is declared effective, which conditions might not be met. Nevertheless, the Company’s continued operations will depend on its ability to raise additional capital through various potential sources, such as equity and/or debt financings, strategic relationships, or outlicensing of its products in order to complete its ongoing and planned Phase 3 clinical trials and until it achieves profitability, if ever. Management is actively pursuing financing plans but 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. The financial statements do not include any adjustments relating to the recoverability and classification of asset carrying amounts or the amount and classification of liabilities that might result should the Company be unable to continue as a going concern. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates. Basis of Consolidation The condensed consolidated financial statements include the accounts of the Company and CorMedix Europe GmbH, its wholly owned subsidiary. All significant intercompany accounts and transactions have been eliminated in consolidation. Impact of Adoption of ASU 2016-09 Effective October 1, 2016, the Company adopted Accounting Standards Update (“ASU”) 2016-09, Compensation — Stock Compensation Improvements to Employee Share-Based Payment Accounting Financial Instruments Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents and short-term investments. The Company maintains its cash and cash equivalents in bank deposit and other interest bearing accounts, the balances of which, at times, may exceed federally insured limits. The appropriate classification of marketable securities is determined at the time of purchase and reevaluated as of each balance sheet date. Investments in marketable debt and equity securities classified as available-for-sale are reported at fair value. Fair value is determined using quoted market prices in active markets for identical assets or liabilities or quoted prices for similar assets or liabilities or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Changes in fair value that are considered temporary are reported net of tax in other comprehensive income (loss). Realized gains and losses, amortization of premiums and discounts and interest and dividends earned are included in income (expense). For declines in the fair value of equity securities that are considered other-than-temporary, impairment losses are charged to other (income) expense, net. The Company considers available evidence in evaluating potential impairments of its investments, including the duration and extent to which fair value is less than cost. There were no deemed permanent impairments at March 31, 2017 or December 31, 2016. The Company’s marketable securities are highly liquid and consist of U.S. government agency securities, high-grade corporate obligations and commercial paper with original maturities of more than 90 days. As of March 31, 2017 and December 31, 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 March 31, 2017 and December 31, 2016: March 31, 2017: Amortized Cost Gross Unrealized Losses Gross Unrealized Gains Fair Value Money Market Funds included in Cash Equivalents $ 282,029 $ — $ — $ 282,029 Corporate Securities 5,455,600 (3,099 ) — 5,452,501 Commercial Paper 1,498,459 — — 1,498,459 Subtotal 6,954,059 (3,099 ) — 6,950,960 Total March 31, 2017 $ 7,236,088 $ (3,099 ) $ — $ 7,232,989 December 31, 2016: Money Market Funds included in Cash Equivalents $ 95,949 $ — $ — $ 95,949 Corporate Securities 10,619,583 (13,212 ) — 10,606,371 Commercial Paper 1,494,549 — — 1,494,549 Subtotal 12,114,132 (13,212 ) — 12,100,920 Total December 31, 2016 $ 12,210,081 $ (13,212 ) $ — $ 12,196,869 Fair Value Measurements The Company’s financial instruments recorded in the consolidated balance sheets include cash and cash equivalents, accounts receivable, investment securities, accounts payable and accrued expenses. The carrying value of certain financial instruments, primarily cash and cash equivalents, accounts receivable, accounts payable, and accrued expenses approximate their estimated fair values based upon the short-term nature of their maturity dates. The Company categorizes its financial instruments into a three-level fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets (Level 1) and the lowest priority to unobservable inputs (Level 3). If the inputs used to measure fair value fall within different levels of the hierarchy, the category level is based on the lowest priority level input that is significant to the fair value measurement of the instrument. Financial assets recorded at fair value on the Company’s condensed consolidated balance sheets are categorized as follows: ● Level 1 inputs—Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets. ● Level 2 inputs— Significant other observable inputs (e.g., quoted prices for similar items in active markets, quoted prices for identical or similar items in markets that are not active, inputs other than quoted prices that are observable such as interest rate and yield curves, and market-corroborated inputs). ● Level 3 inputs—Unobservable inputs for the asset or liability, which are supported by little or no market activity and are The following table provides the carrying value and fair value of the Company’s financial assets measured at fair value on a recurring basis as of March 31, 2017 and December 31, 2016: March 31, 2017: Carrying Value Level 1 Level 2 Level 3 Money Market Funds $ 282,029 $ 282,029 $ — $ — Corporate Securities 5,452,501 — 5,452,501 — Commercial Paper 1,498,459 — 1,498,459 — Subtotal 6,950,960 — 6,950,960 $ — Total March 31, 2017 $ 7,232,989 $ 282,029 $ 6,950,960 $ — December 31, 2016: Money Market Funds $ 95,949 $ 95,949 $ — $ — Corporate Securities 10,606,371 — 10,606,371 — Commercial Paper 1,494,549 — 1,494,549 — Subtotal 12,100,920 — 12,100,920 $ — Total December 31, 2016 $ 12,196,869 $ 95,949 $ 12,100,920 $ — Foreign Currency Translation and Transactions The condensed consolidated financial statements are presented in U.S. Dollars (“USD”), the reporting currency of the Company. For the financial statements of the Company’s foreign subsidiary, whose functional currency is the EURO, foreign currency asset and liability amounts, are translated into USD at end-of-period exchange rates. Foreign currency income and expenses are translated at average exchange rates in effect during the period in which the income and expenses were recognized. Translation gains and losses are included in other comprehensive loss. The Company has intercompany loans between the parent company based in New Jersey and its German subsidiary. The intercompany loans outstanding are not expected to be repaid in the foreseeable future and unrealized foreign exchange movements related to long-term intercompany loans are recognized in other comprehensive income. Foreign currency exchange transaction gain (loss) is the result of re-measuring transactions denominated in a currency other than the functional currency of the entity recording the transaction. Restricted Cash As of March 31, 2017 and December 31, 2016, the Company’s restricted cash is in connection with the patent and utility model infringement proceedings against TauroPharm (see Note 5). The Company was required by the District Court Mannheim to provide a security deposit of approximately $132,000 to cover legal fees in the event TauroPharm is entitled to reimbursement of these costs. The Company furthermore had to provide a deposit in the amount of $40,000 in connection with the unfair competition proceedings in Cologne. Prepaid Research and Development 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, if any, for the Neutrolin product. Inventories consist of the following: March 31, 2017 December 31, 2016 Raw materials $ 79,900 $ 79,900 Work in process 341,118 463,897 Finished goods 103,849 52,936 Inventory reserve (430,000 ) (430,000 ) Total $ 94,867 $ 166,733 Accrued Expenses Accrued expenses consist of the following: March 31, 2017 December 31, 2016 Professional and consulting fees $ 301,280 $ 335,198 Accrued payroll and payroll taxes 565,743 737,607 Clinical trial and manufacturing development 800,270 875,500 Product development 256,916 374,839 Market research 81,877 — Statutory taxes 12,918 1,833 Other 43,965 17,375 Total $ 2,062,969 $ 2,342,352 Revenue Recognition Revenue is recognized from product sales when the following four revenue recognition criteria are met: persuasive evidence of an arrangement exists, delivery has occurred, the selling price is fixed or determinable, and collectability is reasonably assured. The Company recognizes net sales upon shipment of product to the dialysis centers. Deferred Revenue In October 2015, the Company shipped product with less than 75% of its remaining shelf life to a customer and issued a guarantee that the specific product shipped would be replaced by the Company if the customer was not able to sell the product before it expired. 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 the short-dated 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, presented net “deferred revenue” in the condensed consolidated balance sheet. During the three months ended March 31, 2017, the Company recognized $30,000 of deferred revenue and $18,000 in related cost of sales resulting in net amount of $12,000. Also, during the three months ended March 31, 2017, the Company had recorded an additional deferred revenue in the amount of $12,000. 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 March 31, 2017 and 2016. Deferred revenue at March 31, 2017 and December 31, 2016 amounted to approximately $101,000 and $104,000, 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. Three Months Ended March 31, 2017 2016 Series C non-voting convertible preferred stock 2,790,000 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 4,031,468 Shares underlying restricted stock units 107,931 — Shares underlying outstanding stock options 5,637,045 4,483,545 Total 15,980,443 14,819,012 Stock-Based Compensation The Company accounts for stock options granted to employees, officers and directors according to Accounting Standards Codification (“ASC”) No. 718, “Compensation — Stock Compensation” Effective October 1, 2016, the Company adopted ASU 2016-09 to account for forfeitures as they occur. All share-based awards will be recognized on a straight-line method, assuming all awards granted will vest. Forfeitures of share-based awards will be recognized in the period in which they occur. Prior to the adoption of ASU 2016-09, share-based compensation expense was recognized by applying the expected forfeiture rate during the vesting period to the fair value of the award. As of January 1, 2016, a cumulative effect adjustment of $129,730 was recognized to reflect the forfeiture rate that had been applied to unvested option awards prior to fiscal year 2016. As a result of the adoption of ASU 2016-09, the Company’s condensed consolidated statement of operations and comprehensive loss and condensed consolidated statement of cash flows for the three months ended March 31, 2016 were adjusted to reflect the impact. The Company accounts for stock options granted to non-employees on a fair value basis using the Black-Scholes option pricing model in accordance with ASC 718 and ASC No. 505-50, “Equity-Based Payments to Non-Employees” Research and Development Research and development costs are charged to expense as incurred. Research and development includes fees associated with operational consultants, contract clinical research organizations, contract manufacturing organizations, clinical site fees, contract laboratory research organizations, contract central testing laboratories, licensing activities, and allocated executive, human resources and facilities expenses. The Company accrues for costs incurred as the services are being provided by monitoring the status of the trial and the invoices received from its external service providers. As actual costs become known, the Company adjusts its accruals in the period when actual costs become known. Costs related to the acquisition of technology rights and patents for which development work is still in process are charged to operations as incurred and considered a component of research and development expense.

3. Stockholders' Equity

3. Stockholders' Equity	3 Months Ended
	Mar. 31, 2017
STOCKHOLDERS' EQUITY
Stockholders' Equity	Common Stock The Company may issue and sell up to $40.0 million of shares of its common stock from time to time under the Current ATM Program 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 Current ATM Program relates. At March 31, 2017, approximately $3.7 million remained available for sale under the Current ATM Program. When the Company wishes to issue and sell common stock under the Current ATM Program, 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 Current ATM Program. The shares of common stock to be sold under the Current ATM Program are registered under an effective registration statement filed with the SEC. During the quarter ended March 31, 2017, the Company issued 198,630 shares of common stock under the Current ATM Program and realized net proceeds of approximately $347,000. During the quarter ended March 31, 2017, the Company issued 10,000 shares of its common stock upon exercise of stock options resulting in gross proceeds of $6,800 to the Company. During the quarter ended March 31, 2017, the Company issued an aggregate of 75,000 shares of its common stock upon conversion of an aggregate of 7,500 Series C-3 non-voting preferred stock. Stock Options During the three months ended March 31, 2017, the Company granted ten-year qualified and non-qualified stock options covering an aggregate of 1,065,000 shares of the Company’s common stock under the 2013 Stock Incentive Plan. During the three months ended March 31, 2017, and 2016, total compensation expense for stock options issued to employees, directors, officers and consultants was $430,651 and $329,276, respectively. As of March 31, 2017, there was $4,456,538 in total unrecognized compensation expense related to stock options granted which expense will be recognized over an expected remaining weighted average period of 2.2 years. The fair value of the grants are determined using the Black-Scholes option pricing model with the following assumptions: Three Months Ended March 31, 2017 2016 Expected Term 5 years 5 - 10 years Volatility 103.78% - 104.67% 96% Dividend yield 0.00% 0.00% Risk-free interest rate 1.93% - 1.99% 1.25% - 1.94% Weighted average fair value of options granted during the period $ 1.42 $ 1.56 The Company estimated the expected term of the stock options granted based on anticipated exercises in future periods. The expected term of the stock options granted to consultants is based upon the full term of the respective option agreements. Beginning January 1, 2017, the expected stock price volatility for the Company’s stock options is calculated based on the historical volatility since the initial public offering of the Company’s common stock in March 2010. In 2016 the expected stock price volatility was calculated based on the historical volatility since the initial public offering weighted pre and post CE Mark approval in the European Union. The expected dividend yield of 0.0% reflects the Company’s current and expected future policy for dividends on the Company’s common stock. To determine the risk-free interest rate, the Company utilized the U.S. Treasury yield curve in effect at the time of grant with a term consistent with the expected term of the Company’s awards. The following table summarizes the Company’s stock options activity and related information for the three months ended March 31, 2017: Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Outstanding at beginning of period 4,609,755 $ 2.29 8.2 $ 581,823 Exercised (10,000 ) $ 0.68 Forfeited — $ — Expired/Canceled (27,710 ) $ 2.42 Granted 1,065,000 $ 1.84 Outstanding at end of period 5,637,045 $ 2.20 8.5 $ 664,478 Vested at end of period 2,493,807 $ 2.10 7.2 $ 664,009 The total intrinsic value of stock options exercised during the years ended March 31, 2017 and 2016 was $13,200, and $17,600, respectively. The aggregate intrinsic value is calculated as the difference between the exercise prices of the underlying options and the quoted closing price of the common stock of the Company at the end of the reporting period for those options that have an exercise price below the quoted closing price. Restricted Stock Units During the three months ended March 31, 2017, the Company granted an aggregate 107,931 restricted stock units (“RSUs”) to its officers and directors under its 2013 Stock Incentive Plan with a weighted average grant date fair value of $2.22 per share. The fair value of each RSU was estimated to be the closing price of the Company’s common stock on each date of grant. These RSUs will vest over various dates through December 31, 2018. During the three months ended March 31, 2017, compensation expense recorded for these RSUs was $21,372. Unrecognized compensation expense for these RSUs amounted to $218,230. The expected weighted average period for the expense to be recognized is 1.03 years. Warrants As of March 31, 2017, there were 4,006,468 outstanding warrants with a weighted average exercise price of $1.65

4. Related Party Transactions

4. Related Party Transactions	3 Months Ended
	Mar. 31, 2017
Related Party Transactions [Abstract]
Related Party Transactions	In September 2014, as part of the removal of anti-dilution, price reset and change of control provisions in various securities that had caused those securities to be classified as derivative liabilities, the Company entered into a Consent and Exchange Agreement dated September 15, 2014, with Manchester, pursuant to which Manchester has a right of 60% participation in equity financings undertaken by the Company prior to September 15, 2017. Pursuant to this right of participation, Manchester elected partial participation in the equity financing that the Company closed on May 3, 2017 and invested $2,000,000 in that financing, without further investment under its participation rights. On March 3, 2015, the Company entered into a backstop agreement with Manchester which is 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 $3,000,000. The Company did not access the loan and the agreement expired on April 30, 2015. The Company issued two warrants exercisable for an aggregate of up to 283,400 common shares with an exercise price of $7.00 per share and a term of five years as a result of entering into the backstop agreement. Additionally, the Company granted Manchester the right for as long as it or its affiliates hold any of the Company’s common stock or securities convertible into its common stock the right to appoint up to two members to the Company’s board of directors and/or to have up to two observers attend board meetings in a non-voting capacity. As of March 31, 2017 and December 31, 2016, two board members had been appointed to the Company’s board of directors under this provision.

5. Commitments and Contingencie

5. Commitments and Contingencies	3 Months Ended
	Mar. 31, 2017
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 ND Partners’ utility model DE 20 2005 022 124 U1 (the “Utility Model”), which the Company believes is fundamentally identical to the Prosl European Patent in its main aspects and claims. The Court separated the two proceedings and the Prosl European Patent and the Utility Model claims are now being tried separately. TauroPharm has filed a cancellation action against the Utility Model before the German Patent and Trademark Office (the “German PTO”) based on the similar arguments as those in the opposition against the Prosl European Patent. On March 27, 2015, the District Court held a hearing to evaluate whether the Utility Model has been infringed by TauroPharm in connection with the manufacture, sale and distribution of its TauroLock-HEP100TM and TauroLock-HEP500TM products. A hearing before the same court was held on January 30, 2015 on the separate, but related, question of infringement of the Prosl European Patent by TauroPharm. The Court issued its decisions on May 8, 2015, staying both proceedings. In its decisions, the Court found that the commercialization by TauroPharm in Germany of its TauroLock catheter lock solutions Hep100 and Hep500 infringes both the Prosl European Patent and the Utility Model and further that there is no prior use right that would allow TauroPharm to continue to make, use or sell its product in Germany. However, the Court declined to issue an injunction in favor of the Company that would preclude the continued commercialization by TauroPharm based upon its finding that there is a sufficient likelihood that the EPO, in the case of the Prosl European Patent, or the German PTO, in the case of the Utility Model, may find that such patent or utility model is invalid. Specifically, the Court noted the possible publication of certain instructions for product use that may be deemed to constitute prior art. As such, the District Court determined that it will defer any consideration of the request by the Company for injunctive and other relief until such time as the EPO or the German PTO made a final decision on the underlying validity of the Prosl European Patent and the Utility Model. The opposition proceeding against the Prosl European Patent before the EPO is ongoing. The EPO held a hearing in the opposition proceeding on November 25, 2015. In its preliminary consideration of the matter, the EPO (and the German PTO) had regarded the patent as not inventive or novel due to publication of prior art. However, the EPO did not issue a decision at the end of the hearing but adjourned the matter due to the fact that the panel was of the view that Claus Herdeis, one of the managing directors of TauroPharm, has to be heard as a witness in a further hearing in order to close some gaps in the documentation presented by TauroPharm as regards the publication of the prior art. In October 2016, TauroPharm submitted a further writ to the EPO requesting a date for the hearing and bringing forward further arguments, in particular in view of the recent decision of the German PTO on the invalidity of the utility model. The EPO has scheduled a further oral hearing for November 22-23, 2017. While the Company continues to believe that the referenced publication and instructions for use do not, in fact, constitute prior art and that the Prosl European Patent will be found to be valid by the EPO, there can be no assurance that the Company will prevail in this matter. The German PTO held a hearing in the validity proceedings relating to the Utility Model on June 29, 2016, at which the panel affirmed its preliminary finding that the Utility Model was invalid based upon prior publication of a reference to the benefits that may be associated with adding heparin to a taurolidine based solution. The decision has only a declaratory effect, as the Utility Model had expired in November 2015. Furthermore, it has no bearing on the ongoing consideration by the EPO of the validity and possible infringement of the Prosl European Patent. The Company filed an appeal against the ruling on September 7, 2016. On January 16, 2015, the Company filed a complaint against TauroPharm GmbH and its managing directors in the District Court of Cologne, Germany. In the complaint, the Company alleges violation of the German Unfair Competition Act by TauroPharm for the unauthorized use of its proprietary information obtained in confidence by TauroPharm. The Company alleges that TauroPharm is improperly and unfairly using its proprietary information relating to the composition and manufacture of Neutrolin, in the manufacture and sale of TauroPharm’s products TauroLockTM, TauroLock-HEP100 and TauroLock-HEP500. The Company seeks a cease and desist order against TauroPharm from continuing to manufacture and sell any product containing taurolidine (the active pharmaceutical ingredient (“API”) of Neutrolin) and citric acid in addition to possible other components, damages for any sales in the past and the removal of all such products from the market. An initial hearing in the District Court of Cologne, Germany was held on November 19, 2015 to consider the Company’s claims. In this hearing, the presiding judge explained that the court needed more information with regard to several aspects of the case. As a consequence, the court issued an interim decision in the form of a court order outlining several issues of concern that relate primarily to the court's interest in clarifying the facts and reviewing any and all available documentation, in particular with regard to the question which specific know-how was provided to TauroPharm by whom and when. The Company's legal team has prepared the requested reply and produced the respective documentation. TauroPharm has also filed another writ within the same deadline and both parties have filed further writs at the end of April setting out their respective argumentation in more detail. A further oral hearing in this matter was held on November 15, 2016. In this hearing, the court heard arguments from CorMedix and TauroPharm concerning the allegations of unfair competition. The court made no rulings from the bench, and indicated that it is prepared to further examine the underlying facts of the Company's allegations. On March 7, 2017, the court issued another interim decision in the form of a court order outlining again several issues relating to the argumentation of both sides in the proceedings. In particular the court requested the Company to further specify its requests and to further substantiate in even more detail which know know-how was provided by Biolink to TauroPharm by whom and when. The court also raised the question whether the know-how provided at the time to TauroPharm could still be considered to be secret know-how or may have become public in the meantime. The court granted both sides the opportunity to reply to this court order and provide additional facts and evidence until May 15, 2017. The Company has every intention to comply with the court's request. At this time, there are no further hearings scheduled. The Company intends to continue to pursue this matter, and to provide additional supplemental documentary and other evidence as may be necessary to support its claims. In connection with the aforementioned patent and utility model infringement proceedings against TauroPharm, the Company was required by the District Court Mannheim to provide a security deposit of approximately $132,000 to cover legal fees in the event TauroPharm is entitled to reimbursement of these costs. The Company recorded the deposit as restricted cash for the year ended December 31, 2015. The Company furthermore had to provide a deposit in the amount of $40,000 in connection with the unfair competition proceedings in Cologne. These amounts are shown as restricted cash on the condensed consolidated balance sheets. 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 named as defendants several unrelated entities that allegedly were paid stock promoters. Lead Plaintiff alleged 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 sought unspecified damages, interest, attorneys’ fees, and other costs. The Court heard oral argument on this motion on July 18, 2016 and in an order dated October 27, 2016, the Court granted the Cormedix Defendants’ Motion to Dismiss and dismissed with prejudice the Amended Complaint (the “Dismissal Order”). On December 16, 2016, the parties filed a stipulation with the Court in which the plaintiffs and their counsel agreed not to appeal, move for reconsideration or otherwise challenge the Dismissal Order. No settlement payment was made in exchange for the stipulation. 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. Commitments Manufacturing Navinta LLC, a U.S.-based API developer, provides API manufacturing (manufactured in India at an FDA-compliant facility) and a Drug Master File for CRMD003, pursuant to an original supply agreement dated December 7, 2009, as amended (the “Navinta Agreement”). The Navinta Agreement provided that Navinta will supply taurolidine (the API for CRMD003) to the Company on an exclusive worldwide basis in the field of the prevention and treatment of human infection and/or dialysis so long as the Company purchases a minimum of $2,250,000 of product on an annual basis for five years following the Company’s first commercial sale of a product incorporating taurolidine. The Company did not purchase the required amounts and as a result, lost its exclusive manufacturing rights. The Company was also required to make certain cash payments to Navinta upon the achievement of certain sales-based milestones which were based on a tiered approach and would not commence until the Company achieved a designated net sales threshold. The maximum aggregate amount of such payments, assuming achievement of all milestones, was $1,975,000 over five years. The Navinta Agreement expired on March 31, 2016, was not renewed and there are no further purchase obligations or milestone payments. 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 Pharma Connect LLC (“RC2”), pursuant to which RC2 will coordinate certain manufacturing services related to taurolidine that the Company believes are necessary for the submission of its planned new drug application for Neutrolin to the FDA, as well as any foreign regulatory applications. The services under the preliminary service agreement were completed during the quarter ended March 31, 2017 except for the stability studies that are expected to be completed in December 2020. These stability studies will not impact the anticipated timing of approval and launch of Neutrolin in the U.S. The total cost for RC2’s services under the preliminary services agreement is $1.8 million. During the three months ended March 31, 2017 and 2016, the Company recognized research and development expense of $238,000 and $38,000, respectively, for its services related to the agreement. 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 $7.7 million. During the three months ended March 31, 2017 and 2016, the Company recognized research and development expense of approximately $543,000 and $420,000, 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, the Company signed a Master Service Agreement and Work Orders (the “Master Service Agreement”) with PPD Development, LP (“PPD”) for a $19.5 million (originally, $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 currently expected to accrue approximately 632 patients in 70 sites in the U.S. During the three months ended March 31, 2017 and 2016, the Company recognized $2,555,000 and $900,000 in research and development expense related to this agreement, respectively. In-Licensing In 2008, the Company entered into a License and Assignment Agreement (the “NDP License Agreement”) with NDP. Pursuant to the NDP License Agreement, NDP granted the Company exclusive, worldwide licenses for certain antimicrobial catheter lock solutions, processes for treating and inhibiting infections, a biocidal lock system and a taurolidine delivery apparatus, and the corresponding United States and foreign patents and applications (the “NDP Technology”). The Company acquired such licenses and patents through its assignment and assumption of NDP’s rights under certain separate license agreements by and between NDP and Dr. Hans-Dietrich Polaschegg, Dr. Klaus Sodemann and Dr. Johannes Reinmueller. As consideration in part for the rights to the NDP Technology, the Company paid NDP an initial licensing fee of $325,000 and granted NDP a 5% equity interest in the Company, consisting of 39,980 shares of the Company’s common stock. In addition, the Company is required to make payments to NDP upon the achievement of certain regulatory and sales-based milestones. Certain of the milestone payments are to be made in the form of shares of common stock currently held in escrow for NDP, and other milestone payments are to be paid in cash. The maximum aggregate number of shares issuable upon achievement of milestones is 145,543 shares. During the year ended December 31, 2014, a certain milestone was achieved resulting in the release of 36,386 shares held in escrow. The number of shares held in escrow as of December 31, 2016 and 2015 is 109,157 shares of common stock. The maximum aggregate amount of cash payments upon achievement of milestones is $3,000,000 with $2,500,000 remaining at March 31, 2017. Events that trigger milestone payments include but are not limited to the reaching of various stages of regulatory approval and upon achieving certain worldwide net sales amounts. There were no milestones achieved during the three months ended March 31, in 2017 and 2016. The NDP License Agreement may be terminated by the Company on a country-by-country basis upon 60 days prior written notice. If the NDP License Agreement is terminated by either party, the Company’s rights to the NDP Technology will revert back to NDP. Employment Agreements In January 2017, the Company entered into a three-year employment agreement with Robert Cook to serve as its Chief Financial Officer and with Judith Abrams to serve as its Chief Medical Officer, and in March 2017, the Company entered into an employment agreement with John Armstrong to serve as its Executive Vice President for Technical Operations. After the initial three-year term of each employment agreement, the agreement will automatically renew for additional successive one-year periods, unless either party notifies the other in writing at least 90 days before the expiration of the then current term that the agreement will not be renewed. In connection with their employment, the Company granted each of Mr. Cook and Dr. Abrams stock options to purchase 350,000 shares of common stock, with 185,000 of the options vesting in four equal annual installments on the first four anniversaries of the grant date. The remaining 165,000 options are split into three tranches, which become exercisable upon the achievement of specified performance milestones within designated respective time periods. In connection with his employment, the Company granted Mr. Armstrong stock options to purchase 100,000 shares of common stock, which vest upon the achievement of designated milestones. In each case, executive must be an employee of or consultant to the Company on the applicable vesting date. If the Company terminates the employment of Mr. Cook, Dr. Abrams or Mr. Armstrong other than for Cause (as defined in the agreements), death or disability, other than by notice of nonrenewal, or if any of them resigns for Good Reason (as defined in the agreements), he or she will receive his or her base salary and benefits for a period of nine months following the effective date of the termination of employment, and, in the case of Mr. Cook and Dr. Abrams, all unvested time-based stock options that are scheduled to vest on or before the next succeeding anniversary of the date of termination shall be accelerated and deemed to have vested as of the termination date. Other 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 agreement commenced on November 1, 2016 which is renewable every three months for a base monthly payment of €461. Rent expense for the three months ended March 31, 2017 and 2016, was $18,000, and $17,000, respectively. Under the Company’s current lease agreements, the total remaining lease obligation as of March 31, 2017 is set forth below: 2017 $ 46,944 2018 15,000 Total $ 61,944

6. Concentrations

6. Concentrations	3 Months Ended
	Mar. 31, 2017
Concentrations
Concentrations	At March 31, 2017, approximately 86% of net accounts receivable, respectively, was due from one customer. During the year ended December 31, 2016, the Company did not have individual sales in excess of 10% of its total sales.

7. Subsequent Event

7. Subsequent Event	3 Months Ended
	Mar. 31, 2017
Subsequent Event
Subsequent Event	On April 28, 2017, the Company entered into an underwriting agreement with H.C. Wainwright & Co., LLC, relating to an underwritten public offering of 16,190,697 shares of its common stock, par value $0.001 per share, together with Tranche 1 Warrants to purchase up to an aggregate of 12,143,022 shares of its common stock and Tranche 2 Warrants to purchase up to an aggregate of 12,143,022 shares of its common stock, at a price to the public of $0.75 per share with related warrants. Each Tranche 1 Warrant has an exercise price of $1.05 per share of common stock and will expire five years following the Exercisable Date (defined below). Each Tranche 2 Warrant has an exercise price of $0.75 per share of common stock and will expire thirteen months following the Exercisable Date. The Company also granted the underwriters a 30-day option to purchase up to an additional 2,428,604 additional shares of common stock and/or Tranche 1 Warrants to purchase up to 1,821,453 Shares and Tranche 2 Warrants to purchase up to 1,821,453 Shares, which option was exercised in full, resulting in the sale and issuance of a total of 18,619,301 shares of common stock, Tranche 1 Warrants to purchase up to an aggregate of 13,964,475 shares of its common stock and Tranche 2 Warrants to purchase up to an aggregate of 13,964,475 shares of its common stock. The offering closed on May 3, 2017. The gross proceeds from the sale of shares was approximately $14.0 million, before deducting underwriting discounts and commissions and estimated offering expenses. Manchester partially exercised its participation rights and invested $2,000,000 in the offering, without further investment under its participation rights. The Company paid the underwriter, H.C. Wainwright & Co., LLC, a commission equal to 6.0% of the gross proceeds of the offering and also issued warrants to purchase up to an aggregate of 1,117,158 shares of common stock, with an exercise price of $0.9375, which represents 125% of the public offering price per combined share and related warrants. The underwriter warrant will expire five years following the Exercisable Date. Other than the exercise price, the terms of the underwriter warrant are the same as the Tranche 1 warrants. The Company does not currently have a sufficient number of authorized shares of common stock to cover the shares issuable upon exercise of the warrants issued in the offering to investors and the underwriter. As a result, before any warrants can become exercisable, the Company needs to receive stockholder approval of an amendment to its Amended and Restated Certificate of Incorporation (the “Charter Amendment”) to increase the number of authorized shares of common stock to a total of 200,000,000 shares at its next annual meeting of stockholders on June 6, 2017. The warrants will be exercisable on any day on or after the date that the Company publicly announces through the filing of a Current Report on Form 8-K that the Charter Amendment has been approved by its stockholders and has become effective (the “Exercisable Date”). In the event the stockholders do not approve the Charter Amendment, the warrants will not be exercisable and may not have any value. The Company agreed to not sell any equity securities until the later of the date that the Company receives approval of the Charter Amendment on July 27, 2017.

2. Summary of Significant Acc14

2. Summary of Significant Accounting Policies (Policies)	3 Months Ended
	Mar. 31, 2017
Accounting Policies [Abstract]
Liquidity, Going Concern and Uncertainties	The Company’s operations are subject to a number of factors that can affect its operating results and financial condition. Such factors include, but are not limited to: the Company’s ability to raise capital to support its operations; the results of clinical testing and trial activities of the Company’s product candidates; the ability to obtain regulatory approval to market the Company’s products; competition from products manufactured and sold or being developed by other companies; the price of, and demand for, Company products; the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products. The financial statements have been prepared in conformity with GAAP which contemplate continuation of the Company as a going concern. To date, the Company’s commercial operations have not generated sufficient revenues to enable profitability. As of March 31, 2017, the Company had an accumulated deficit of $126.8 million, and had incurred losses from operations of $7.6 million for the quarter then ended. 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 March 31, 2017, even after giving effect to the proceeds that the Company received from the equity financing that closed on May 3, 2017 (see Note 7), will not be sufficient to fund operations for at least the next twelve months following the filing of the Company’s report on Form 10-Q for the quarter ended March 31, 2017. These factors raise substantial doubt regarding the Company’s ability to continue as a going concern. At March 31, 2017, approximately $3.7 million remained available for sale under an April 2015 AttheMarket Issuance Sales Agreement (the “Current ATM program”) with MLV & Co. LLC (“MLV”), now a subsidiary of FBR Capital Markets & Co. (“FBR”), pursuant to which the Company is able to issue and sell up to $40 million of shares of its common stock from time to time. At March 31, 2017, the Company also had $60.0 million available under its current shelf registration for the issuance of equity, debt or equitylinked securities unrelated to the Current ATM program. The sale of any equity securities under this portion of the shelf registration statement is subject to participation rights held by Machester Securities Corp. ("Manchester") pursuant to which Manchester must either be offered 60% participation in such equity financing or the Company must obtain a waiver from Manchester. On May 3, 2017, the Company closed on an equity financing which raised net proceeds of approximately $12.8 million (see Note 7). In August 2016, the Company entered into a new sales agreement with FBR whereby the Company can sell up to $40 million of shares of its common stock (the “Pending ATM Program”), but only if the Company obtains a waiver from Manchester of its participation rights and the pending registration statement covering the Pending ATM Program is declared effective, which conditions might not be met. Nevertheless, the Company’s continued operations will depend on its ability to raise additional capital through various potential sources, such as equity and/or debt financings, strategic relationships, or outlicensing of its products in order to complete its ongoing and planned Phase 3 clinical trials and until it achieves profitability, if ever. Management is actively pursuing financing plans but 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. The financial statements do not include any adjustments relating to the recoverability and classification of asset carrying amounts or the amount and classification of liabilities that might result should the Company be unable to continue as a going concern.
Use of Estimates	The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates.
Basis of Consolidation	The condensed consolidated financial statements include the accounts of the Company and CorMedix Europe GmbH, its wholly owned subsidiary. All significant intercompany accounts and transactions have been eliminated in consolidation.
Impact of Adoption of ASU 2016-09	Effective October 1, 2016, the Company adopted Accounting Standards Update (“ASU”) 2016-09, Compensation — Stock Compensation Improvements to Employee Share-Based Payment Accounting
Financial Instruments	Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents and short-term investments. The Company maintains its cash and cash equivalents in bank deposit and other interest bearing accounts, the balances of which, at times, may exceed federally insured limits. The appropriate classification of marketable securities is determined at the time of purchase and reevaluated as of each balance sheet date. Investments in marketable debt and equity securities classified as available-for-sale are reported at fair value. Fair value is determined using quoted market prices in active markets for identical assets or liabilities or quoted prices for similar assets or liabilities or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Changes in fair value that are considered temporary are reported net of tax in other comprehensive income (loss). Realized gains and losses, amortization of premiums and discounts and interest and dividends earned are included in income (expense). For declines in the fair value of equity securities that are considered other-than-temporary, impairment losses are charged to other (income) expense, net. The Company considers available evidence in evaluating potential impairments of its investments, including the duration and extent to which fair value is less than cost. There were no deemed permanent impairments at March 31, 2017 or December 31, 2016. The Company’s marketable securities are highly liquid and consist of U.S. government agency securities, high-grade corporate obligations and commercial paper with original maturities of more than 90 days. As of March 31, 2017 and December 31, 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 March 31, 2017 and December 31, 2016: March 31, 2017: Amortized Cost Gross Unrealized Losses Gross Unrealized Gains Fair Value Money Market Funds included in Cash Equivalents $ 282,029 $ — $ — $ 282,029 Corporate Securities 5,455,600 (3,099 ) — 5,452,501 Commercial Paper 1,498,459 — — 1,498,459 Subtotal 6,954,059 (3,099 ) — 6,950,960 Total March 31, 2017 $ 7,236,088 $ (3,099 ) $ — $ 7,232,989 December 31, 2016: Money Market Funds included in Cash Equivalents $ 95,949 $ — $ — $ 95,949 Corporate Securities 10,619,583 (13,212 ) — 10,606,371 Commercial Paper 1,494,549 — — 1,494,549 Subtotal 12,114,132 (13,212 ) — 12,100,920 Total December 31, 2016 $ 12,210,081 $ (13,212 ) $ — $ 12,196,869
Fair Value Measurements	The Company’s financial instruments recorded in the consolidated balance sheets include cash and cash equivalents, accounts receivable, investment securities, accounts payable and accrued expenses. The carrying value of certain financial instruments, primarily cash and cash equivalents, accounts receivable, accounts payable, and accrued expenses approximate their estimated fair values based upon the short-term nature of their maturity dates. The Company categorizes its financial instruments into a three-level fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets (Level 1) and the lowest priority to unobservable inputs (Level 3). If the inputs used to measure fair value fall within different levels of the hierarchy, the category level is based on the lowest priority level input that is significant to the fair value measurement of the instrument. Financial assets recorded at fair value on the Company’s condensed consolidated balance sheets are categorized as follows: ● Level 1 inputs—Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets. ● Level 2 inputs— Significant other observable inputs (e.g., quoted prices for similar items in active markets, quoted prices for identical or similar items in markets that are not active, inputs other than quoted prices that are observable such as interest rate and yield curves, and market-corroborated inputs). ● Level 3 inputs—Unobservable inputs for the asset or liability, which are supported by little or no market activity and are The following table provides the carrying value and fair value of the Company’s financial assets measured at fair value on a recurring basis as of March 31, 2017 and December 31, 2016: March 31, 2017: Carrying Value Level 1 Level 2 Level 3 Money Market Funds $ 282,029 $ 282,029 $ — $ — Corporate Securities 5,452,501 — 5,452,501 — Commercial Paper 1,498,459 — 1,498,459 — Subtotal 6,950,960 — 6,950,960 $ — Total March 31, 2017 $ 7,232,989 $ 282,029 $ 6,950,960 $ — December 31, 2016: Money Market Funds $ 95,949 $ 95,949 $ — $ — Corporate Securities 10,606,371 — 10,606,371 — Commercial Paper 1,494,549 — 1,494,549 — Subtotal 12,100,920 — 12,100,920 $ — Total December 31, 2016 $ 12,196,869 $ 95,949 $ 12,100,920 $ —
Foreign Currency Translation and Transactions	The condensed consolidated financial statements are presented in U.S. Dollars (“USD”), the reporting currency of the Company. For the financial statements of the Company’s foreign subsidiary, whose functional currency is the EURO, foreign currency asset and liability amounts, are translated into USD at end-of-period exchange rates. Foreign currency income and expenses are translated at average exchange rates in effect during the period in which the income and expenses were recognized. Translation gains and losses are included in other comprehensive loss. The Company has intercompany loans between the parent company based in New Jersey and its German subsidiary. The intercompany loans outstanding are not expected to be repaid in the foreseeable future and unrealized foreign exchange movements related to long-term intercompany loans are recognized in other comprehensive income. Foreign currency exchange transaction gain (loss) is the result of re-measuring transactions denominated in a currency other than the functional currency of the entity recording the transaction.
Restricted Cash	As of March 31, 2017 and December 31, 2016, the Company’s restricted cash is in connection with the patent and utility model infringement proceedings against TauroPharm (see Note 5). The Company was required by the District Court Mannheim to provide a security deposit of approximately $132,000 to cover legal fees in the event TauroPharm is entitled to reimbursement of these costs. The Company furthermore had to provide a deposit in the amount of $40,000 in connection with the unfair competition proceedings in Cologne.
Prepaid Research and Development 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, if any, for the Neutrolin product. Inventories consist of the following: March 31, 2017 December 31, 2016 Raw materials $ 79,900 $ 79,900 Work in process 341,118 463,897 Finished goods 103,849 52,936 Inventory reserve (430,000 ) (430,000 ) Total $ 94,867 $ 166,733
Accrued Expenses	Accrued expenses consist of the following: March 31, 2017 December 31, 2016 Professional and consulting fees $ 301,280 $ 335,198 Accrued payroll and payroll taxes 565,743 737,607 Clinical trial and manufacturing development 800,270 875,500 Product development 256,916 374,839 Market research 81,877 — Statutory taxes 12,918 1,833 Other 43,965 17,375 Total $ 2,062,969 $ 2,342,352
Revenue Recognition	Revenue is recognized from product sales when the following four revenue recognition criteria are met: persuasive evidence of an arrangement exists, delivery has occurred, the selling price is fixed or determinable, and collectability is reasonably assured. The Company recognizes net sales upon shipment of product to the dialysis centers.
Deferred Revenue	In October 2015, the Company shipped product with less than 75% of its remaining shelf life to a customer and issued a guarantee that the specific product shipped would be replaced by the Company if the customer was not able to sell the product before it expired. 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 the short-dated 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, presented net “deferred revenue” in the condensed consolidated balance sheet. During the three months ended March 31, 2017, the Company recognized $30,000 of deferred revenue and $18,000 in related cost of sales resulting in net amount of $12,000. Also, during the three months ended March 31, 2017, the Company had recorded an additional deferred revenue in the amount of $12,000. 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 March 31, 2017 and 2016. Deferred revenue at March 31, 2017 and December 31, 2016 amounted to approximately $101,000 and $104,000, 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. Three Months Ended March 31, 2017 2016 Series C non-voting convertible preferred stock 2,790,000 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 4,031,468 Shares underlying restricted stock units 107,931 — Shares underlying outstanding stock options 5,637,045 4,483,545 Total 15,980,443 14,819,012
Stock-Based Compensation	The Company accounts for stock options granted to employees, officers and directors according to Accounting Standards Codification (“ASC”) No. 718, “Compensation — Stock Compensation” Effective October 1, 2016, the Company adopted ASU 2016-09 to account for forfeitures as they occur. All share-based awards will be recognized on a straight-line method, assuming all awards granted will vest. Forfeitures of share-based awards will be recognized in the period in which they occur. Prior to the adoption of ASU 2016-09, share-based compensation expense was recognized by applying the expected forfeiture rate during the vesting period to the fair value of the award. As of January 1, 2016, a cumulative effect adjustment of $129,730 was recognized to reflect the forfeiture rate that had been applied to unvested option awards prior to fiscal year 2016. As a result of the adoption of ASU 2016-09, the Company’s condensed consolidated statement of operations and comprehensive loss and condensed consolidated statement of cash flows for the three months ended March 31, 2016 were adjusted to reflect the impact. The Company accounts for stock options granted to non-employees on a fair value basis using the Black-Scholes option pricing model in accordance with ASC 718 and ASC No. 505-50, “Equity-Based Payments to Non-Employees”
Research and Development	Research and development costs are charged to expense as incurred. Research and development includes fees associated with operational consultants, contract clinical research organizations, contract manufacturing organizations, clinical site fees, contract laboratory research organizations, contract central testing laboratories, licensing activities, and allocated executive, human resources and facilities expenses. The Company accrues for costs incurred as the services are being provided by monitoring the status of the trial and the invoices received from its external service providers. As actual costs become known, the Company adjusts its accruals in the period when actual costs become known. Costs related to the acquisition of technology rights and patents for which development work is still in process are charged to operations as incurred and considered a component of research and development expense.

2. Summary of Significant Acc15

2. Summary of Significant Accounting Policies (Tables)	3 Months Ended
	Mar. 31, 2017
Accounting Policies [Abstract]
Marketable securities	March 31, 2017: Amortized Cost Gross Unrealized Losses Gross Unrealized Gains Fair Value Money Market Funds included in Cash Equivalents $ 282,029 $ — $ — $ 282,029 Corporate Securities 5,455,600 (3,099 ) — 5,452,501 Commercial Paper 1,498,459 — — 1,498,459 Subtotal 6,954,059 (3,099 ) — 6,950,960 Total March 31, 2017 $ 7,236,088 $ (3,099 ) $ — $ 7,232,989 December 31, 2016: Money Market Funds included in Cash Equivalents $ 95,949 $ — $ — $ 95,949 Corporate Securities 10,619,583 (13,212 ) — 10,606,371 Commercial Paper 1,494,549 — — 1,494,549 Subtotal 12,114,132 (13,212 ) — 12,100,920 Total December 31, 2016 $ 12,210,081 $ (13,212 ) $ — $ 12,196,869
Carrying and fair value of financial assets	March 31, 2017: Carrying Value Level 1 Level 2 Level 3 Money Market Funds $ 282,029 $ 282,029 $ — $ — Corporate Securities 5,452,501 — 5,452,501 — Commercial Paper 1,498,459 — 1,498,459 — Subtotal 6,950,960 — 6,950,960 $ — Total March 31, 2017 $ 7,232,989 $ 282,029 $ 6,950,960 $ — December 31, 2016: Money Market Funds $ 95,949 $ 95,949 $ — $ — Corporate Securities 10,606,371 — 10,606,371 — Commercial Paper 1,494,549 — 1,494,549 — Subtotal 12,100,920 — 12,100,920 $ — Total December 31, 2016 $ 12,196,869 $ 95,949 $ 12,100,920 $ —
Schedule of inventories	March 31, 2017 December 31, 2016 Raw materials $ 79,900 $ 79,900 Work in process 341,118 463,897 Finished goods 103,849 52,936 Inventory reserve (430,000 ) (430,000 ) Total $ 94,867 $ 166,733
Schedule of accrued expenses	March 31, 2017 December 31, 2016 Professional and consulting fees $ 301,280 $ 335,198 Accrued payroll and payroll taxes 565,743 737,607 Clinical trial and manufacturing development 800,270 875,500 Product development 256,916 374,839 Market research 81,877 — Statutory taxes 12,918 1,833 Other 43,965 17,375 Total $ 2,062,969 $ 2,342,352
Schedule of anti-dilutive securities excluded from calculation of diluted net loss per share	Three Months Ended March 31, 2017 2016 Series C non-voting convertible preferred stock 2,790,000 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 4,031,468 Shares underlying restricted stock units 107,931 — Shares underlying outstanding stock options 5,637,045 4,483,545 Total 15,980,443 14,819,012

3. Stockholders' Equity (Tables

3. Stockholders' Equity (Tables)	3 Months Ended
	Mar. 31, 2017
STOCKHOLDERS' EQUITY
Fair value assumptions for Black Sholes	Three Months Ended March 31, 2017 2016 Expected Term 5 years 5 - 10 years Volatility 103.78% - 104.67% 96% Dividend yield 0.00% 0.00% Risk-free interest rate 1.93% - 1.99% 1.25% - 1.94% Weighted average fair value of options granted during the period $ 1.42 $ 1.56
Summary of Option Activity under Plan and Related Information	Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Outstanding at beginning of period 4,609,755 $ 2.29 8.2 $ 581,823 Exercised (10,000 ) $ 0.68 Forfeited — $ — Expired/Canceled (27,710 ) $ 2.42 Granted 1,065,000 $ 1.84 Outstanding at end of period 5,637,045 $ 2.20 8.5 $ 664,478 Vested at end of period 2,493,807 $ 2.10 7.2 $ 664,009

5. Commitments and Contingenc17

5. Commitments and Contingencies (Tables)	3 Months Ended
	Mar. 31, 2017
Commitments and Contingencies Disclosure [Abstract]
Schedule of Future Minimum Rental Payments for Operating Leases	2017 $ 46,944 2018 15,000 Total $ 61,944

2. Summary of Significant Acc18

2. Summary of Significant Accounting Policies (Details) - USD ($)	3 Months Ended	12 Months Ended
	Mar. 31, 2017	Dec. 31, 2016
Amortized cost	$ 7,236,088	$ 12,210,081
Gross unrealized losses	(3,099)	(13,212)
Gross unrealized gains	0	0
Fair value	7,232,989	12,196,869
Money Market Funds included in Cash Equivalents
Amortized cost	282,029	95,949
Gross unrealized losses	0	0
Gross unrealized gains	0	0
Fair value	282,029	95,949
Corporate Securities
Amortized cost	5,455,600	10,619,583
Gross unrealized losses	(3,099)	(13,212)
Gross unrealized gains	0	0
Fair value	5,452,501	10,606,371
Commercial Paper
Amortized cost	1,498,459	1,494,549
Gross unrealized losses	0	0
Gross unrealized gains	0	0
Fair value	1,498,459	1,494,549
Subtotal
Amortized cost	6,954,059	12,114,132
Gross unrealized losses	(3,099)	(13,212)
Gross unrealized gains	0	0
Fair value	$ 6,950,960	$ 12,100,920

2. Summary of Significant Acc19

2. Summary of Significant Accounting Policies (Details 1) - USD ($)	Mar. 31, 2017	Dec. 31, 2016
Carrying Value	$ 7,232,989	$ 12,196,869
Level 1
Carrying Value	282,029	95,949
Level 2
Carrying Value	6,950,960	12,100,920
Level 3
Carrying Value	0	0
Money Market Funds included in Cash Equivalents
Carrying Value	282,029	95,949
Money Market Funds included in Cash Equivalents | Level 1
Carrying Value	282,029	95,949
Money Market Funds included in Cash Equivalents | Level 2
Carrying Value	0	0
Money Market Funds included in Cash Equivalents | Level 3
Carrying Value	0	0
Corporate Securities
Carrying Value	5,452,501	10,606,371
Corporate Securities | Level 1
Carrying Value	0	0
Corporate Securities | Level 2
Carrying Value	5,452,501	10,606,371
Corporate Securities | Level 3
Carrying Value	0	0
Commercial Paper
Carrying Value	1,498,459	1,494,549
Commercial Paper | Level 1
Carrying Value	0	0
Commercial Paper | Level 2
Carrying Value	1,498,459	1,494,549
Commercial Paper | Level 3
Carrying Value	0	0
Subtotal
Carrying Value	6,950,960	12,100,920
Subtotal | Level 1
Carrying Value	0	0
Subtotal | Level 2
Carrying Value	6,950,960	12,100,920
Subtotal | Level 3
Carrying Value	$ 0	$ 0

2. Summary of Significant Acc20

2. Summary of Significant Accounting Policies (Details 2) - USD ($)	Mar. 31, 2017	Dec. 31, 2016
Summary Of Significant Accounting Policies Details 2
Raw materials	$ 79,900	$ 79,900
Work in process	341,118	463,897
Finished goods	103,849	52,936
Inventory reserve	(430,000)	(430,000)
Total	$ 94,867	$ 166,733

2. Summary of Significant Acc21

2. Summary of Significant Accounting Policies (Details 3) - USD ($)	Mar. 31, 2017	Dec. 31, 2016
Accounting Policies [Abstract]
Professional and consulting fees	$ 301,280	$ 335,198
Accrued payroll and payroll taxes	565,743	737,607
Clinical trial and manufacturing development	800,270	875,500
Product development	256,916	374,839
Market research	81,877	0
Statutory taxes	12,918	1,833
Other	43,965	17,375
Total	$ 2,062,969	$ 2,342,352

2. Summary of Significant Acc22

2. Summary of Significant Accounting Policies (Details 4) - shares	3 Months Ended
	Mar. 31, 2017	Mar. 31, 2016
Antidilutive Shares	15,980,443	14,819,012
Series C non-voting convertible preferred stock
Antidilutive Shares	2,790,000	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	4,031,468
Shares underlying restricted stock units
Antidilutive Shares	107,931	0
Shares underlying outstanding stock options
Antidilutive Shares	5,637,045	4,483,545

2. Summary of Significant Acc23

2. Summary of Significant Accounting Policies (Details Narrative) - USD ($)	3 Months Ended
	Mar. 31, 2017	Mar. 31, 2016	Dec. 31, 2016
Summary Of Significant Accounting Policies Details Narrative
Accumulated deficit	$ (126,761,812)		$ (119,164,952)
Loss from operations	(7,619,005)	$ (4,148,537)
Deferred revenue	$ 101,000		$ 104,000

3. Stockholders' Equity (Detail

3. Stockholders' Equity (Details) - $ / shares	3 Months Ended
	Mar. 31, 2017	Mar. 31, 2016
Stockholders Equity Details
Expected Term	5 years
Expected Term, minimum		5 years
Expected Term, maximum		10 years
Volatility		96.00%
Volatility, minimum	103.78%
Volatility, maximum	104.67%
Dividend yield	0.00%	0.00%
Risk-free interest rate, minimum	1.93%	1.25%
Risk-free interest rate, maximum	1.99%	1.94%
Weighted-average fair value of options granted during the period	$ 1.42	$ 1.56

3. Stockholders' Equity (Deta25

3. Stockholders' Equity (Details 1)	3 Months Ended
	Mar. 31, 2017USD ($)$ / sharesshares
Stockholders Equity Details 1
Number of Options Outstanding, Beginning | shares	4,609,755
Number of Options Exercised | shares	(10,000)
Number of Options Forfeited | shares	0
Number of Options Expired/Canceled | shares	(27,710)
Number of Options Granted | shares	1,065,000
Number of Options Outstanding, Ending | shares	5,637,045
Number of Options Vested | shares	2,493,807
Weighted Average Exercise Price Outstanding, Beginning | $ / shares	$ 2.29
Weighted Average Exercise Price Exercised | $ / shares	.68
Weighted Average Exercise Price Forfeited | $ / shares	0
Weighted Average Exercise Price Expired/Canceled | $ / shares	2.42
Weighted Average Exercise Price Granted | $ / shares	1.84
Weighted Average Exercise Price Outstanding, Ending | $ / shares	2.20
Weighted Average Exercise Price, Vested | $ / shares	$ 2.10
Weighted Average Remaining Contractual Life (in years) Outstanding, Beginning	8 years 2 months 12 days
Weighted Average Remaining Contractual Life (in years) Outstanding, Ending	8 years 6 months
Weighted Average Remaining Contractual Life (in years), Vested	7 years 2 months 12 days
Aggregate Intrinsic Value Outstanding, Beginning | $	$ 581,823
Aggregate Intrinsic Value Outstanding, Ending | $	664,478
Aggregate Intrinsic Value, Vested | $	$ 664,009

3. Stockholders' Equity (Deta26

3. Stockholders' Equity (Details Narrative) - USD ($)	3 Months Ended
	Mar. 31, 2017	Mar. 31, 2016
Stock-based compensation	$ 430,651	$ 329,276
Unrecognized compensation expense	$ 4,456,538
Warrants, outstanding	4,006,468
Warrants, weighted average exercise price	$ 1.65
Warrants, weighted average remaining contractual life	2 years 1 month 10 days
Restricted Stock Unit
Stock-based compensation	$ 21,372
Unrecognized compensation expense	$ 218,230

5. Commitments and Contingenc27

5. Commitments and Contingencies (Details)	Mar. 31, 2017USD ($)
Commitments And Contingencies Details
2,017	$ 46,944
2,018	15,000
Total	$ 61,944

5. Commitments and Contingenc28

5. Commitments and Contingencies (Details Narrative) - USD ($)	3 Months Ended
	Mar. 31, 2017	Mar. 31, 2016
Research and development expense	$ 4,924,267	$ 2,089,592
Rent expense	18,000	17,000
RC2
Research and development expense	238,000	38,000
RC2
Research and development expense	543,000	420,000
PPD
Research and development expense	$ 2,555,000	$ 900,000

6. Concentrations (Details Narr

6. Concentrations (Details Narrative)	3 Months Ended
	Mar. 31, 2017
One Customer | Accounts Receivable
Concentration risk	86.00%