CorMedix (CRMD) 10-Q 14 Aug 19 2019 Q2 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	6 Months Ended
	Jun. 30, 2019	Aug. 12, 2019
Document And Entity Information
Entity Registrant Name	CorMedix Inc.
Entity Central Index Key	0001410098
Document Type	10-Q
Document Period End Date	Jun. 30, 2019
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Is Entity's Reporting Status Current?	Yes
Entity Filer Category	Non-accelerated Filer
Entity Emerging Growth Company	false
Entity Small Business	true
Entity Common Stock, Shares Outstanding		23,824,508
Document Fiscal Period Focus	Q2
Document Fiscal Year Focus	2019

CONDENSED CONSOLIDATED BALANCE

CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($)	Jun. 30, 2019	Dec. 31, 2018
Current assets
Cash and cash equivalents	$ 14,561,830	$ 17,623,770
Restricted cash	171,553	171,553
Short-term investments	11,824,642	0
Trade receivables	0	10,904
Inventories, net	402,714	428,515
Prepaid research and development expenses	248,711	8,113
Other prepaid expenses and current assets	203,155	422,199
Total current assets	27,412,605	18,665,054
Property and equipment, net	146,601	160,860
TOTAL ASSETS	27,559,206	18,825,914
Current liabilities
Accounts payable	906,084	2,588,977
Accrued expenses	3,433,754	5,166,224
Deferred revenue	6,618	11,029
Total current liabilities	4,346,456	7,766,230
Operating lease liabilities, net of current portion	3,487	0
Convertible note, related party, net	6,734,212	6,125,428
TOTAL LIABILITIES	11,084,155	13,891,658
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS' EQUITY
Preferred stock - $0.001 par value: 2,000,000 shares authorized;369,585 and 419,585 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively	370	420
Common stock - $0.001 par value: 160,000,000 shares authorized;23,820,334 and 21,775,173 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively	23,821	21,775
Accumulated other comprehensive income	104,340	96,522
Additional paid-in capital	201,198,660	183,803,637
Accumulated deficit	(184,852,140)	(178,988,098)
TOTAL STOCKHOLDERS' EQUITY	16,475,051	4,934,256
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$ 27,559,206	$ 18,825,914

CONDENSED CONSOLIDATED BALANC_2

CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares	Jun. 30, 2019	Dec. 31, 2018
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	369,585	419,585
Preferred stock, shares outstanding	369,585	419,585
Common stock, par value	$ 0.001	$ 0.001
Common stock, shares authorized	160,000,000	160,000,000
Common stock, shares issued	23,820,334	21,775,173
Common stock, shares outstanding	23,820,334	21,775,173

CONDENSED CONSOLIDATED STATEMEN

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2019	Jun. 30, 2018	Jun. 30, 2019	Jun. 30, 2018
Revenue
Net sales	$ 35,266	$ 7,551	$ 198,958	$ 30,760
Cost of sales	(21,128)	(33,663)	(248,083)	(62,238)
Gross profit (loss)	14,138	(26,112)	(49,125)	(31,478)
Operating Expenses
Research and development	(2,979,907)	(6,600,213)	(5,854,903)	(14,880,657)
Selling, general and administrative	(2,571,587)	(1,945,825)	(4,556,509)	(3,848,838)
Total Operating Expenses	(5,551,494)	(8,546,038)	(10,411,412)	(18,729,495)
Loss From Operations	(5,537,356)	(8,572,150)	(10,460,537)	(18,760,973)
Other Income (Expense)
Interest income	95,964	10,196	154,785	24,971
Foreign exchange transaction gain (loss)	(8,808)	5,043	(10,285)	(4,154)
Interest expense, including amortization of debt discount	(306,736)	0	(608,783)	(1,873)
Total Other Income (Expense)	(219,580)	15,239	(464,283)	18,944
Loss before income taxes	(5,756,936)	(8,556,911)	(10,924,820)	(18,742,029)
Tax benefit	5,060,778	0	5,060,778	0
Net Loss	(696,158)	(8,556,911)	(5,864,042)	(18,742,029)
Other Comprehensive Income (Loss):
Unrealized gain from investment	8,846	0	7,839	0
Foreign currency translation gain (loss)	285	395	(21)	(1,030)
Total Other Comprehensive Income (Loss)	9,131	395	7,818	(1,030)
Comprehensive Loss	$ (687,027)	$ (8,556,516)	$ (5,856,224)	$ (18,743,059)
Net Loss Per Common Share - Basic and Diluted	$ (0.03)	$ (0.52)	$ (0.25)	$ (1.19)
Weighted Average Common Shares Outstanding - Basic and Diluted	23,825,773	16,470,865	23,451,988	15,738,605

CONDENSED CONSOLIDATED STATEM_2

CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS' EQUITY (Unaudited) - USD ($)	Common Stock	Non-Voting Preferred Stock - Series B, Series C-2, Series C-3, Series D and Series E	Accumulated Other Comprehensive Income (Loss)	Additional Paid-In Capital	Accumulated Deficit	Total
Beginning balance, Shares at Dec. 31, 2017	14,282,758	419,585
Beginning balance, Amount at Dec. 31, 2017	$ 14,283	$ 420	$ 98,433	$ 159,255,081	$ (152,174,866)	$ 7,193,351
Stock issued in connection with ATM sale of common stock, net, Shares	2,040,420
Stock issued in connection with ATM sale of common stock, net, Amount	$ 2,040			3,267,123		3,269,163
Issuance of vested restricted stock, Shares	8,677
Issuance of vested restricted stock, Amount	$ 9			(9)
Stock issued for payment of deferred fees, Shares	25,526
Stock issued for payment of deferred fees, Amount	$ 25			173,748		173,773
Stock-based compensation				373,293		373,293
Cumulative effect of adoption of ASC 606					17,655	17,655
Other comprehensive (loss) income			(1,425)			(1,425)
Net loss					(10,185,118)	(10,185,118)
Ending balance, Shares at Mar. 31, 2018	16,357,381	419,585
Ending balance, Amount at Mar. 31, 2018	$ 16,357	$ 420	97,008	163,069,236	(162,342,329)	840,692
Beginning balance, Shares at Dec. 31, 2017	14,282,758	419,585
Beginning balance, Amount at Dec. 31, 2017	$ 14,283	$ 420	98,433	159,255,081	(152,174,866)	7,193,351
Other comprehensive (loss) income						(1,030)
Net loss						(18,742,029)
Ending balance, Shares at Jun. 30, 2018	17,003,848	419,585
Ending balance, Amount at Jun. 30, 2018	$ 17,004	$ 420	97,403	164,307,314	(170,900,158)	(6,478,017)
Beginning balance, Shares at Mar. 31, 2018	16,357,381	419,585
Beginning balance, Amount at Mar. 31, 2018	$ 16,357	$ 420	97,008	163,069,236	(162,342,329)	840,692
Stock issued in connection with ATM sale of common stock, net, Shares	646,467
Stock issued in connection with ATM sale of common stock, net, Amount	$ 647			879,903		880,550
Stock-based compensation				358,175		358,175
Cumulative effect of adoption of ASC 606					(918)	(918)
Other comprehensive (loss) income			395			395
Net loss					(8,556,911)	(8,556,911)
Ending balance, Shares at Jun. 30, 2018	17,003,848	419,585
Ending balance, Amount at Jun. 30, 2018	$ 17,004	$ 420	97,403	164,307,314	(170,900,158)	(6,478,017)
Beginning balance, Shares at Dec. 31, 2018	21,775,173	419,585
Beginning balance, Amount at Dec. 31, 2018	$ 21,775	$ 420	96,522	183,803,637	(178,988,098)	4,934,256
Stock issued in connection with ATM sale of common stock, net, Shares	1,768,012
Stock issued in connection with ATM sale of common stock, net, Amount	$ 1,768			15,232,761		15,234,529
Stock issued in connection with warrants exercised, shares	119,220
Stock issued in connection with warrants exercised, amount	$ 119			620,161		620,280
Stock issued in connection with stock options exercised, shares	35,840
Stock issued in connection with stock options exercised, amount	$ 36			112,730		112,766
Conversion of Series C-3 non-voting preferred stock to common stock, shares	100,000	(50,000)
Conversion of Series C-3 non-voting preferred stock to common stock, amount	$ 100	$ (50)		(50)
Issuance of vested restricted stock, Shares	6,667
Issuance of vested restricted stock, Amount	$ 7			(7)
Reversal of common stock issued as a result of reverse stock split rounding, Shares	6,722
Reversal of common stock issued as a result of reverse stock split rounding, Amount	$ 7			(7)
Stock-based compensation				809,331		809,331
Other comprehensive (loss) income			(1,313)			(1,313)
Net loss					(5,167,884)	(5,167,884)
Ending balance, Shares at Mar. 31, 2019	23,811,634	369,585
Ending balance, Amount at Mar. 31, 2019	$ 23,812	$ 370	95,209	200,578,556	(184,155,982)	16,541,965
Beginning balance, Shares at Dec. 31, 2018	21,775,173	419,585
Beginning balance, Amount at Dec. 31, 2018	$ 21,775	$ 420	96,522	183,803,637	(178,988,098)	4,934,256
Other comprehensive (loss) income						7,818
Net loss						(5,864,042)
Ending balance, Shares at Jun. 30, 2019	23,820,334	369,585
Ending balance, Amount at Jun. 30, 2019	$ 23,821	$ 370	104,340	201,198,660	(184,852,140)	16,475,051
Beginning balance, Shares at Mar. 31, 2019	23,811,634	369,585
Beginning balance, Amount at Mar. 31, 2019	$ 23,812	$ 370	95,209	200,578,556	(184,155,982)	16,541,965
Stock issued in connection with warrants exercised, shares	2,625
Stock issued in connection with warrants exercised, amount	$ 3			13,779		13,782
Issuance of vested restricted stock, Shares	6,275
Issuance of vested restricted stock, Amount	$ 6			(6)
Reversal of common stock issued as a result of reverse stock split rounding, Shares	(200)
Reversal of common stock issued as a result of reverse stock split rounding, Amount						0
Stock-based compensation				606,331		606,331
Other comprehensive (loss) income			9,131			9,131
Net loss					(696,158)	(696,158)
Ending balance, Shares at Jun. 30, 2019	23,820,334	369,585
Ending balance, Amount at Jun. 30, 2019	$ 23,821	$ 370	$ 104,340	$ 201,198,660	$ (184,852,140)	$ 16,475,051

CONDENSED CONSOLIDATED STATEM_3

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($)	6 Months Ended
	Jun. 30, 2019	Jun. 30, 2018
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$ (5,864,042)	$ (18,742,029)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation	1,415,662	731,468
Amortization of debt discount	229,095	0
Non-cash interest expense	379,688	0
Depreciation	40,470	38,734
Changes in operating assets and liabilities:
Decrease in trade receivables	10,728	61,220
Decrease (increase) in inventory	25,801	(78,743)
Decrease (increase) in prepaid expenses and other current assets	(21,523)	263,151
(Decrease) increase in accounts payable	(1,682,752)	5,498,465
(Decrease) increase in accrued expenses	(1,731,730)	911,636
Decrease in deferred revenue	(4,412)	(73,686)
Net cash (used in) operating activities	(7,203,015)	(11,389,784)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of short-term investments	(13,246,855)	0
Maturity of short-term investments	1,430,052	1,604,198
Purchase of equipment	(22,725)	(38,225)
Net cash (used in) provided by investing activities	(11,839,528)	1,565,973
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from sale of common stock from at-the-market program	15,234,529	4,149,713
Proceeds from exercise of warrants	634,062	0
Proceeds from exercise of stock options	112,766	0
Net cash provided by financing activities	15,981,357	4,149,713
Foreign exchange effect on cash	(754)	(3,653)
NET DECREASE IN CASH	(3,061,940)	(5,677,751)
CASH, CASH EQUIVALENTS AND RESTRICTED CASH - BEGINNING OF PERIOD	17,795,323	10,551,282
CASH, CASH EQUIVALENTS AND RESTRICTED CASH - END OF PERIOD	14,733,383	4,873,531
Cash paid for interest	0	1,873
Supplemental Disclosure of Non-Cash Financing Activities:
Conversion of preferred stock to common stock	50	0
Issuance of common stock for payment of deferred fees	0	173,773
Right-of-use assets obtained in exchange for lease liability	6,000	0
Issuance of common stock for vested restricted stock units	$ 13	$ 43

1. Organization, Business and B

1. Organization, Business and Basis of Presentation	6 Months Ended
	Jun. 30, 2019
Organization, Consolidation and Presentation of Financial Statements [Abstract]
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. The Company’s primary focus is to develop its lead product candidate, Neutrolin®, for potential commercialization in the United States, or U.S., and other key markets. Neutrolin is a novel anti-infective solution (a formulation of taurolidine 1.35%, citrate 3.5%, and heparin 1000 u/ml) intended for the reduction and prevention of catheter-related infections and thrombosis in patients requiring central venous catheters (“CVCs”) in clinical settings such as dialysis, critical/intensive care, and oncology. Infection and thrombosis represent key complications among dialysis, critical care/intensive care and cancer patients with CVCs that can lead to treatment delays and increased costs to the healthcare system when they occur due to hospitalizations, need for intra-venous (“IV”) antibiotic treatment, long-term anticoagulation therapy, removal/replacement of the CVC, related treatment costs and increased mortality. The Company believes Neutrolin addresses a significant unmet medical need and represents a potential large market opportunity. The Company received CE Mark approval for Neutrolin in 2013 and commercially launched Neutrolin in Germany for the prevention of catheter-related bloodstream infections and maintenance of catheter patency in hemodialysis patients using a tunneled, cuffed central venous catheter for vascular access. The Company formed a wholly-owned subsidiary, CorMedix Europe GmbH, to direct the Company’s commercial activities in certain European Union (“EU”) and Middle Eastern countries in which Neutrolin is registered for sale. In December 2015, CorMedix launched its first Phase 3 clinical trial in hemodialysis patients with CVCs in the U.S. The clinical trial, named Catheter Lock Solution Investigational Trial (“LOCK-IT-100”), was a prospective, multicenter, randomized, double-blind, active control trial which aimed to demonstrate the efficacy and safety of Neutrolin in preventing catheter-related bloodstream infections (“CRBSI”), in subjects receiving hemodialysis therapy as treatment for end stage renal disease. The primary endpoint for the trial was time to CRBSI. The trial evaluated whether Neutrolin was superior to the active control heparin by documenting the incidence of CRBSI and the time until the occurrence of CRBSI. Secondary endpoints were catheter patency, which is defined as required use of tissue plasminogen activating factor, or removal of the catheter for any reason. In July 2018, the Company announced that the independent Data Safety Monitoring Board (“DSMB”) had completed its review of the interim analysis of the data from LOCK-IT-100 and, because the pre-specified level of statistical significance was reached and efficacy had been demonstrated, the DSMB recommended the study be terminated early. No safety concerns were reported by the DSMB. The Company has been in discussions with the U.S. Food and Drug Administration (“FDA”) on the appropriate next steps to support regulatory approval for Neutrolin. Based on written feedback provided by the FDA, the Company announced in July 2019 that it believes LOCK-IT-100 is sufficient to support a planned New Drug Application (“NDA”) for Neutrolin and that the Company does not need to conduct a second clinical trial prior to filing of the NDA. The Company is continuing its discussions with the FDA concerning other requirements for filing the NDA. In February 2019, the Company announced that the FDA had agreed that CorMedix could request consideration of Neutrolin for approval under the Limited Population Pathway for Antibacterial and Antifungal Drugs, or LPAD. LPAD, passed as part of the 21st Century Cures Act, is a new program intended to expedite the development of drug products, which allows for the FDA’s determination of safety and effectiveness to reflect the risk-benefit profile of the drug in the intended limited population, taking into account the severity, rarity, or prevalence of the infection and the availability of alternative treatments in the limited population. CorMedix is evaluating opportunities for the possible expansion of taurolidine as a platform compound for use in wound closure, surgical meshes, wound management, and osteoarthritis, including visco-supplementation. The Company is also involved in a pre-clinical research collaboration for the use of taurolidine in combination with certain anti-cancer drugs as a possible treatment for rare orphan pediatric tumors. In February 2018, the FDA granted orphan drug designation to taurolidine for the treatment of neuroblastoma. 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 8 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 to fairly state the interim results. Interim operating results are not necessarily indicative of results that may be expected for the full year ending December 31, 2019 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 14, 2019. The accompanying condensed balance sheet as of December 31, 2018 has been derived from the audited financial statements included in such Form 10-K. On March 26, 2019, the Company effected a 1-for-5 reverse stock split of its issued and outstanding shares of common stock, par value $0.001 per share, by combining, reclassifying and changing each authorized and outstanding five shares of “old” common stock into one share of “new” common stock. No fractional shares were issued, and, in lieu thereof, where applicable, one whole share was issued. To reflect the reverse stock split, reclassification, combination and change, proportional adjustments were also made to the number of shares of the Company’s common stock issuable upon conversion of outstanding preferred shares and the convertible note payable, warrants and options and other equity awards. The reverse stock split did not affect the par value per share of the Company’s common stock (which remains at $0.001 per share) or the total number of shares of common stock that are authorized to be issued pursuant to the Company’s Amended and Restated Certificate of Incorporation, as amended, which remains at 160 million shares Recently Adopted Accounting Pronouncements In June 2018, the Financial Accounting Standards Board (“FASB”) issued new guidance which expands the scope of the FASB’s Accounting Standards Codification (“ASC”) 718, to include share-based payment transactions for acquiring goods and services from nonemployees. Early adoption is permitted and the Company elected to adopt the guidance effective in the first quarter of fiscal year 2019. This adoption on January 1, 2019 did not have a material impact on the Company’s consolidated financial statements. In July 2017, the FASB issued new guidance which changes the classification analysis of certain equity-linked financial instruments (or embedded features) with down round features and recharacterizes the indefinite deferral of certain provisions within the guidance for distinguishing liabilities from equity. Early adoption is permitted and the Company elected to adopt the guidance effective in the first quarter of fiscal year 2019. This adoption on January 1, 2019 did not have a material impact on the Company’s consolidated financial statements. In February 2016, the FASB issued new guidance related to how an entity should lease assets and lease liabilities. The guidance specifies that an entity who is a lessee under lease agreements should recognize lease assets and lease liabilities for those leases classified as operating leases under previous FASB guidance. The Company adopted the standard on January 1, 2019 using the transition method provided by the FASB. Under this transition method, the Company applied the new requirements to only those leases that exist as of January 1, 2019, rather than at the earliest comparative period presented in the financial statements. Prior periods will be presented under existing lease guidance. Upon transition, the Company applied the package of practical expedients permitted under ASC 842 transition guidance. As a result, the Company did not reassess (1) whether expired or existing contracts contain leases under the new definition of a lease, including whether an existing or expired contract contains an embedded lease, (2) lease classification for expired or existing leases and (3) any initial direct costs of existing leases. As a result of the adoption, the Company recorded right-of-use assets and lease liabilities of approximately $6,000 each. Adoption of the standard did not have a material impact on the Company’s consolidated statements of operations and comprehensive income (loss) or cash from or used in operating, investing or financing activities on its consolidated statements of cash flows.

2. Summary of Significant Accou

2. Summary of Significant Accounting Policies	6 Months Ended
	Jun. 30, 2019
Accounting Policies [Abstract]
Summary of Significant Accounting Policies	Liquidity and Uncertainties 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 June 30, 2019, the Company had an accumulated deficit of $184.9 million, and incurred losses from operations of $0.7 million and $8.6 million for the three months ended June 30, 2019 and 2018, respectively, and $5.9 million and $18.7 million for the six months ended June 30, 2019 and 2018, respectively. The Company currently estimates that as of June 30, 2019 it has sufficient cash on hand to fund operations into the third quarter 2020, including the submission of the NDA for Neutrolin and initial preparations for commercial launch. The company currently anticipates that FDA marketing approval for Neutrolin could be received in the second half of 2020. In April 2019, the Company received approximately $5.1 million, net of expenses, from the sale of a portion of its unused New Jersey net operating losses (“NOL”). The NOL was sold through the State of New Jersey’s Economic Development Authority (“NJEDA”) Technology Business Tax Certificate Transfer program, which allowed the Company to sell approximately $5.4 million of its total $6.1 million in available NOL tax benefits. 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 out-licensing of its products, to commercially launch Neutrolin upon NDA approval, and until profitability is achieved, if ever. Management can provide no assurances that such financing or strategic relationships will be available on acceptable terms, or at all. At the financial reporting date, the Company has approximately $4.6 million available under its current ATM program and $30.3 million available under its current shelf registration for the issuance of equity, debt or equity-linked securities unrelated to the current ATM program. The Company’s operations are subject to a number of other factors that can affect its operating results and financial condition. Such factors include, but are not limited to: the results of clinical testing and trial activities of the Company’s product candidates; the ability to obtain regulatory approval to market the Company’s products; ability to manufacture successfully; competition from products manufactured and sold or being developed by other companies; the price of, and demand for, Company products; the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products; and the Company’s ability to raise capital to support its operations. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates. Basis of Consolidation The condensed consolidated financial statements include the accounts of the Company and CorMedix Europe GmbH, its wholly owned subsidiary. All significant intercompany accounts and transactions have been eliminated in consolidation. Financial Instruments Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents and short-term investments. The Company maintains its cash and cash equivalents in bank deposit and other interest-bearing accounts, the balances of which, at times, may exceed federally insured limits. The appropriate classification of marketable securities is determined at the time of purchase and reevaluated as of each balance sheet date. Investments in marketable debt and equity securities classified as available-for-sale are reported at fair value. Fair value is determined using quoted market prices in active markets for identical assets or liabilities or quoted prices for similar assets or liabilities or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Changes in fair value that are considered temporary are reported in the condensed consolidated statement of operations. 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 June 30, 2019 or December 31, 2018. 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 June 30, 2019 and December 31, 2018, all of the Company’s investments had contractual maturities of less than one year. The following table summarizes the amortized cost, unrealized gains and losses and the fair value at June 30, 2019 and December 31, 2018: June 30, 2019: Amortized Cost Gross Unrealized Losses Gross Unrealized Gains Fair Value Money Market Funds and Cash Equivalents $ 3,480,030 $ (236 ) $ - $ 3,479,794 U.S. Government Agency Securities 2,834,818 - 2,085 2,836,903 Corporate Securities 7,593,871 (367 ) 5,050 7,598,554 Commercial Paper 1,387,879 - 1,306 1,389,185 Subtotal 11,816,568 (367 ) 8,441 11,824,642 Total June 30, 2019 $ 15,296,598 $ (603 ) $ 8,441 $ 15,304,436 December 31, 2018: Money Market Funds included in Cash Equivalents $ 1,179,673 $ - $ - $ 1,179,673 Total December 31, 2018 $ 1,179,673 $ - $ - $ 1,179,673 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 June 30, 2019 and December 31, 2018: June 30, 2019: Carrying Value Level 1 Level 2 Level 3 Money Market Funds and Cash Equivalents $ 3,479,794 $ 2,083,007 $ 1,396,787 $ - U.S. Government Agency Securities 2,836,903 2,836,903 - - Corporate Securities 7,598,554 - 7,598,554 - Commercial Paper 1,389,185 - 1,389,185 - Subtotal 11,824,642 2,836,903 8,987,739 $ - Total June 30, 2019 $ 15,304,436 $ 4,919,910 $ 10,384,526 $ - December 31, 2018: Money Market Funds $ 1,179,673 $ 1,179,673 $ - $ - Total December 31, 2018 $ 1,179,673 $ 1,179,673 $ - $ - Foreign Currency Translation and Transactions The condensed consolidated financial statements are presented in U.S. Dollars (“USD”), the reporting currency of the Company. For the financial statements of the Company’s foreign subsidiary, whose functional currency is the EURO, foreign currency asset and liability amounts, are translated into USD at end-of-period exchange rates. Foreign currency income and expenses are translated at average exchange rates in effect during the period in which the income and expenses were recognized. Translation gains and losses are included in other comprehensive income (loss). The Company has intercompany loans between the parent company based in New Jersey and its German subsidiary. The intercompany loans outstanding are not expected to be repaid in the foreseeable future and unrealized foreign exchange movements related to long-term intercompany loans are recognized in other comprehensive income (loss). Foreign currency exchange transaction gain (loss) is the result of re-measuring transactions denominated in a currency other than the functional currency of the entity recording the transaction. Restricted Cash As of June 30, 2019 and December 31, 2018, the Company has restricted cash in connection with the patent and utility model infringement proceedings against TauroPharm (see Note 6). 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 net realizable value on a first in, first out basis. Inventories consist of raw materials (including labeling and packaging), work-in-process, and finished goods, if any, for the Neutrolin product. Inventories consist of the following: June 30, 2019 December 31, 2018 Raw materials $ 6,893 $ 71,275 Work in process 86,437 86,957 Finished goods 412,384 373,283 Inventory reserve (103,000 ) (103,000 ) Total $ 402,714 $ 428,515 Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets, current portion of operating lease liabilities, and operating lease liabilities, net of current portion, on the consolidated balance sheet. Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. The Company has elected, as an accounting policy, not to apply the recognition requirements in ASC 842 to short-term leases. Short-term leases are leases that have a term of 12 months or less and do not include an option to purchase the underlying asset that the Company is reasonably certain to exercise. The Company recognizes the lease payments for short-term leases on a straight-line basis over the lease term. The Company has also elected, as a practical expedient, by underlying class of asset, not to separate lease components from non-lease components and, instead, account for them as a single component. Accrued Expenses Accrued expenses consist of the following: June 30, 2019 December 31, 2018 Professional and consulting fees $ 273,637 $ 258,352 Accrued payroll and payroll taxes 765,941 1,102,143 Clinical trial related 1,749,437 3,408,032 Manufacturing development related 424,427 210,577 Product development 49,200 49,200 Other 171,112 137,920 Total $ 3,433,754 $ 5,166,224 Revenue Recognition The Company recognizes revenue in accordance with ASC 606, “ Revenue from Contracts with Customers”. The Company recognizes net sales upon shipment of product and upon meeting the five-step model prescribed by ASC 606 outlined above. Deferred Revenue 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”). Product registration in the Territory is contingent upon the marketing approval of Neutrolin in the U.S. 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 is being recognized as revenue on a straight-line basis over the contractual term of the Agreement. The Company recognized $2,200 of revenue related to the Wonik Agreement for each of the three months ended June 30, 2019 and 2018 and $4,400 for the six months ended June 30, 2019 and 2018, respectively. Deferred revenue related to the Wonik Agreement at June 30, 2019 and December 31, 2018 amounted to approximately $6,600 and $11,000, 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. Six Months Ended June 30, 2019 2018 Series C non-voting preferred stock 408,000 508,000 Series D non-voting preferred stock 295,848 295,848 Series E non-voting preferred stock 391,953 391,953 Series F non-voting preferred stock 2,469,137 2,469,137 Shares issuable upon conversion of convertible debt 1,000,000 - Restricted stock units 13,642 19,506 Shares issuable for payment of deferred board compensation 30,553 24,528 Shares underlying outstanding warrants 3,197,163 4,578,579 Shares underlying outstanding stock options 1,297,793 1,101,159 Total potentially dilutive shares 9,104,089 9,388,710 Stock-Based Compensation The Company accounts for stock options granted according to ASC No. 718, “Compensation — Stock Compensation” 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 activities and the invoices received from its external service providers. Costs related to the acquisition of technology rights and patents for which development work is still in process are charged to operations as incurred and considered a component of research and development expense.

3. Stockholders' Equity

3. Stockholders' Equity	6 Months Ended
	Jun. 30, 2019
STOCKHOLDERS' EQUITY
Stockholders' Equity	Common Stock On March 9, 2018, the Company entered into a new agreement (the “new ATM agreement”) with B. Riley for the sale of up to $14.7 million of the Company’s common stock under the Company’s ATM program, pursuant to a registration statement filed on March 9, 2018 for an aggregate of $70.0 million of the Company’s securities, which became effective on April 16, 2018. This new ATM agreement replaced a prior sales agreement with B. Riley that expired on April 16, 2018, under which the Company could issue and sell up to an aggregate of $60.0 million of shares of its common stock. The ATM program amount was increased by $25.0 million in November 2018. Under the ATM program, the Company may issue and sell common stock from time to time through B. Riley acting as agent, subject to limitations imposed by the Company and subject to B. Riley’s acceptance, such as the number or dollar amount of shares registered under the registration statement to which the offering relates. B. Riley is entitled to a commission of up to 3% of the gross proceeds from the sale of common stock sold under the ATM program. During the six months ended June 30, 2019, the Company sold 1,768,012 shares of common stock under the ATM program and realized net proceeds of approximately $15.2 million, respectively. There were no ATM sales during the three months ended June 30, 2019. At June 30, 2019, the Company has approximately $4.6 million available under its current ATM program and $30.3 million available under its current shelf registration for the issuance of equity, debt or equity-linked securities unrelated to the current ATM program. During the six months ended June 30, 2019, the Company issued an aggregate of 121,845 and 35,840 shares of its common stock upon exercise of warrants and stock options, respectively, resulting in net proceeds to the Company of $634,000 and $113,000, respectively. During the six months ended June 30, 2019, the Company issued 100,000 shares of its common stock upon conversion of 50,000 shares of Series C-3 non-voting preferred stock. During the six months ended June 30, 2019, the Company issued an aggregate of 12,942 shares of its common stock upon the vesting of restricted stock units issued to the Company’s board of directors. Preferred Stock The Company is authorized to issue up to 2,000,000 shares of preferred stock in one or more series without stockholder approval. The Company’s board of directors has the discretion to determine the rights, preferences, privileges and restrictions, including voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences, of each series of preferred stock. Of the 2,000,000 shares of preferred stock authorized, the Company’s board of directors has designated (all with par value of $0.001 per share) the following: As of June 30, 2019 As of December 31, 2018 Preferred Shares Outstanding Liquidation Preference (Per Share) Total Liquidation Preference Preferred Shares Outstanding Liquidation Preference (Per Share) Total Liquidation Preference Series C-2 150,000 $ 10.00 $ 1,500,000 150,000 $ 10.00 $ 1,500,000 Series C-3 54,000 $ 10.00 $ 540,000 104,000 $ 10.00 $ 1,040,000 Series D 73,962 $ 21.00 $ 1,553,202 73,962 $ 21.00 $ 1,553,202 Series E 89,623 $ 49.20 $ 4,409,452 89,623 $ 49.20 $ 4,409,452 Series F 2,000 $ 1,000.00 $ 2,000,000 2,000 $ 1,000.00 $ 2,000,000 Total 369,585 $ 10,002,654 419,585 $ 10,502,654 On November 9, 2017, the Company entered into a securities purchase agreement with existing institutional investors (the “Buyers”), pursuant to which, on November 16, 2017, the Company sold $2.0 million of its Series F convertible preferred stock (“Series F Stock”) at $1,000 per share. Based on the terms of the Series F Stock, the conversion price was set at $0.162 on April 2, 2018, currently convertible anytime at the Buyers’ option. The conversion price of the Series F Stock is subject to anti-dilution adjustment for customary recapitalization events such as stock splits, as well as full ratchet anti-dilution protection in the event that the Company does not obtain the subordination of the Series C-3 preferred stock to that of the Series F Stock or obtain stockholder approval, if required by NYSE American rules, of the issuance of common stock that exceeds NYSE American rules. The Series F Stock became mandatorily convertible on April 2, 2018, subject to certain equity conditions, one of which was not met as of March 31, 2018. The last condition to be met is the subordination of the outstanding Series C-3 preferred stock to the Series F Stock. When and if that condition is met, the Series F Stock will be mandatorily convertible. Pursuant to the terms of the Series F Stock, a holder will be prohibited from converting shares of Series F Stock into shares of common stock if, as a result of such conversion, (i) such holder, together with its affiliates, would beneficially own more than 9.99% of the total number of shares of the Company’s common stock then issued and outstanding, or (ii) the Company would issue shares in an amount equal to or greater than 20% of the shares of common stock outstanding on November 9, 2017, unless the Company has received the approval of its stockholders for such overage. Stock Options During the six months ended June 30, 2019, the Company granted ten-year qualified and non-qualified stock options covering an aggregate of 344,300 shares of the Company’s common stock under the 2013 Stock Incentive Plan. The weighted average exercise price of these options is $7.88 per share. During the three and six months ended June 30, 2019, total compensation expense for stock options issued to employees, directors, officers and consultants was $557,000 and $1,317,000, respectively, and $337,000 and $687,000 for the three and six months ended June 30, 2018, respectively. As of June 30, 2019, there was $2,520,000 in total unrecognized compensation expense related to stock options granted, which expense will be recognized over an expected remaining weighted average period of 1.34 years. The fair value of each stock option award estimated on the grant date is determined using the Black-Scholes option pricing model with the following assumptions, for the six months ended June 30, 2019: Expected term 4.17 - 10 years Volatility 102.80% - 162.98% Dividend yield 0.0% Risk-free interest rate 2.31% - 2.74% Weighted average grant date fair value of options granted during the period $6.74 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. The expected stock price volatility for the Company’s stock options is calculated based on the historical volatility since the initial public offering of the Company’s common stock in March 2010. The expected dividend yield of 0.0% reflects the Company’s current and expected future policy for dividends on the Company’s common stock. To determine the risk-free interest rate, the Company utilized the U.S. Treasury yield curve in effect at the time of grant with a term consistent with the expected term of the Company’s awards which is 5 years for employees and 10 years for non-employees. The following table summarizes the Company’s stock options activity and related information for the six months ended June 30, 2019: Shares Weighted Average Weighted Average Aggregate Intrinsic Value Outstanding at beginning of period 1,011,267 $ 9.32 6.5 $ 1,897,363 Granted 344,300 $ 7.88 $ 374,061 Forfeited (21,757 ) $ 6.45 $ 54,910 Expired (177 ) $ 3.66 $ 935 Exercised (35,840 ) $ 3.15 $ 208,716 Outstanding at end of period 1,297,793 $ 9.16 7.1 $ 2,006,863 Exercisable at end of period 767,241 $ 9.18 6.0 $ 1,449,328 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. There were no stock options exercised during the six months ended June 30, 2018. Restricted Stock Units During the six months ended June 30, 2019, the Company granted an aggregate of 23,600 restricted stock units (“RSUs”) to its directors under its 2013 Stock Incentive Plan with a weighted average grant date fair value of $8.30 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 vest monthly over one year after grant date, subject to continued service on the board through the vesting date. During the three and six months ended June 30, 2019, compensation expense recorded for the RSUs was $49,000 and $99,000, respectively, and $21,000 and $44,000 for the three and six months ended June 30, 2018, respectively. Unrecognized compensation expense for these RSUs amounted to $98,000. The expected weighted average period for the expense to be recognized is 0.30 years. Warrants As of June 30, 2019, there were 3,197,163 outstanding warrants with a weighted average exercise price of $5.50 During the quarter ended June 30, 2019, the expiration date of the warrant to purchase up to 100,000 shares of the Company’s common stock was extended from May 30, 2019 to July 1, 2019, then subsequently extended to August 13, 2019. The warrant has an exercise price of $0.005. The incremental value of the warrant extended is immaterial. See Note 4 below.

4. Related Party

4. Related Party	6 Months Ended
	Jun. 30, 2019
Related Party Transactions [Abstract]
Related Party	In May 2013, the Company issued a warrant to purchase up to 100,000 shares of the Company’s common stock to Manchester Securities Corp. (“Manchester”), a wholly owned subsidiary of Elliott Associates, L.P. (together with Manchester, “Elliott”). The warrant had an expiration date of May 30, 2019. In May 2019, to allow the Company and Elliott time to discuss and possibly conclude a potential restructuring of the Company’s capital structure, the Company extended the expiration date of the warrant to July 1, 2019, which was subsequently extended to August 16, 2019. The warrant has an exercise price of $0.005.

5. Senior Secured Convertible N

5. Senior Secured Convertible Note	6 Months Ended
	Jun. 30, 2019
Debt Disclosure [Abstract]
Senior Secured Convertible Note	On December 31, 2018, the Company entered into a securities purchase agreement with Manchester Securities Corp., a wholly owned subsidiary of Elliott Associates, L.P. (“Elliott”), the Company’s largest stockholder, for the purchase and sale of a senior secured convertible note in the aggregate principal amount of $7.5 million and a warrant to purchase up to an aggregate of 90,000 shares of our common stock, for gross proceeds of $7.5 million. The note is a senior obligation, secured by all of the Company’s assets. The note bears interest at the rate of 10.0% per annum, compounded quarterly. Interest was first payable on January 2, 2019, and on the first trading day of each month thereafter. The note matures on December 30, 2021. Any accrued but unpaid interest for the applicable interest period will be added to the principal outstanding under the notes. The note has a conversion price of $7.50 per share. The conversion price is subject to appropriate adjustment in the event of stock dividends and distributions, stock splits, stock combinations, or reclassifications affecting our common stock. The noteholder may convert its outstanding note principal amount, and any accrued and unpaid interest, at any time into shares of common stock at the conversion rate. Additionally, the note will automatically convert into shares of common stock if, prior to the maturity date, the average closing sale price of the Company’s common stock for any 20 trading days during any consecutive 30 trading days equals or exceeds 150% of the conversion price. The Company has the right to pay any accrued interest in cash for any calendar month during which the average closing sale price of its common stock averaged at least 150% of the conversion price of the notes. On or after July 1, 2020, the Company may prepay any principal amount outstanding on the notes in amounts of $2,000,000 (or in full, if less than $2,000,000), provided that if the prepayment occurs between July 2, 2020 and March 30, 2021, the prepayment amount will equal 110% of the principal amount being repaid and if the prepayment occurs after March 31, 2021, the prepayment amount will equal 105% of the principal amount being repaid. The warrant is immediately exercisable, has an exercise price of $7.50 per share, subject to adjustment in the event of stock dividends and distributions, stock splits, stock combinations, or reclassifications affecting our common stock, and has a term of five years. The closing of the note and warrant sale and purchase occurred simultaneously with entry into the securities purchase agreement. No placement agent or underwriter was involved in the offering. On the same date, and in connection with the sale of the note and warrant, the Company amended and restated the following warrants held by Elliott and its affiliates to reduce the exercise price of each warrant to $0.005 per share: warrants issued in May 2013 to purchase up to an aggregate of 100,000 shares of the Company’s common stock with a pre-amendment exercise price of $3.25 per share and an expiration date of May 30, 2019, which was subsequently extended to August 13, 2019 (the “May 30, 2019 Warrants”), see Note 4; and warrants issued in October 2013 to purchase up to an aggregate of 150,000 shares of our common stock with a pre-amendment exercise price of $4.50 per share and an expiration date of October 22, 2019 (the “October 22, 2019 Warrants”). Also in conjunction with the closing of the sale and issuance, the Company and Elliott and certain of its affiliates that hold shares of various series of the Company’s preferred stock and warrants to purchase shares of the Company’s common stock agreed to waive any rights of conversion or exercise for all of the shares of its Series C-2, D, E and F preferred stock and shares issuable upon the exercise of certain warrants (collectively with the shares of Series C-2, D, E, and F preferred stock, the "Elliott Derivative Securities"), until the earliest to occur of (i) the effective date on which the Company’s Certificate of Incorporation is amended to increase the number of authorized shares of common stock, (ii) the effective date on which the Company effects a reverse stock split of its common stock, (iii) one business day immediately prior to the consummation of a fundamental transaction (as defined in the instruments governing the applicable Elliott Derivative Securities), and (iv) April 30, 2019. The 1-for-5 reverse stock split that was effective on March 26, 2019 satisfied this condition and Elliott is able to convert and exercise all of the preferred shares and warrants cited above. As long as any of the Series C-2, Series D, Series E or Series F non-voting convertible preferred stock is outstanding, the Company cannot, without the consent of a majority of those series preferred holders, incur any indebtedness other than trade payables incurred in the ordinary course of business consistent with past practice, and letters of credit incurred in an aggregate amount of $3.0 million at any point in time. Elliott is the holder of all of the shares of the Series C-2, Series D, Series E and Series F non-voting convertible preferred stock and implicitly consented to the convertible note financing. The $7.5 million in gross proceeds, along with the legal fees of approximately $109,000, were allocated between the senior secured convertible note and warrants based on their relative fair values. The portion of the proceeds allocated to the warrants of approximately $396,000, net of allocated fees of approximately $6,000, was accounted for as additional paid-in capital. The remainder of the proceeds of approximately $7.0 million, net of allocated fees of approximately $103,000 was allocated to the senior convertible note, with the fair value of the warrants resulting in a debt discount. In addition, the incremental cost of approximately $710,000 associated with the warrant modification was recorded as a debt discount. An additional debt discount of approximately $143,000 was recorded as a beneficial conversion feature as the stock price was greater than the effective conversion price (after allocation of the total proceeds) on the measurement date. The debt discount is being amortized to interest expense using the effective interest method in accordance with ASC 835 over the term of the agreement. For the three and six months ended June 30, 2019, approximately $114,000 and $229,000 was recognized as amortization of debt discount and is included in interest expense on the condensed consolidated statement of operations and comprehensive income (loss). For the three and six months ended June 30, 2019, approximately $192,000 and $380,000 of interest expense has been accrued, respectively. The Company used a hybrid valuation model to determine the fair value of the senior secured convertible note. The hybrid model incorporated both a present value analysis and the use of the Black Scholes option pricing model to reflect the senior secured convertible note’s conversion feature. The Black-Scholes option pricing model was also used to determine the fair value of the warrants in order to allocate the gross proceeds based on relative fair values (see Note 1). ASC 820, “Fair Value Measurements,”

6. Commitments and Contingencie

6. Commitments and Contingencies	6 Months Ended
	Jun. 30, 2019
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 the formulation of taurolidine and citrate with low dose heparin in a catheter lock solution for maintaining patency and preventing infection in hemodialysis catheters. 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. 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. An oral hearing has been scheduled for September 17, 2019. 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 June 2016 decision of the German PTO on the invalidity of the utility model, which we have appealed. On November 22, 2017, the EPO in Munich, Germany held a further oral hearing in this matter. At the hearing, the panel held that the Prosl European Patent would be invalidated because it did not meet the requirements of novelty based on a technical aspect of the European intellectual property law. The Company disagrees with this decision and, after the written opinion was issued by the Opposition Division in September 2018, has appealed the decision. The Company continues to believe that the Prosl European Patent is indeed novel and that its validity should be maintained. There can be no assurance that the Company will prevail in this matter with either the German PTO or the EPO. In addition, the ongoing Unfair Competition litigation brought by the Company against TauroPharm is not affected and will continue. 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 2016 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-how was provided by Biolink to TauroPharm by whom and when. The court also raised the question whether the know-how provided at the time to TauroPharm could still be considered to be secret know-how or may have become public in the meantime. The court granted both sides the opportunity to reply to this court order and provide additional facts and evidence until May 15, 2017. Both parties have submitted further writs in this matter and the court scheduled a further hearing on May 8, 2018. After having been rescheduled several times, the hearing took place on November 20, 2018. A decision was rendered by the court on December 11, 2018, dismissing the complaint in its entirety. However, the Company intends to continue to pursue this matter, and still believes firmly that its claims are well-founded. The Company therefore appealed in January 2019 and filed its grounds of appeal in March 2019. An oral hearing has been scheduled for September 6, 2019. In connection with the aforementioned patent and utility model infringement proceedings against TauroPharm, the Company was required by the District Court Mannheim to provide a security deposit of approximately $132,000 to cover legal fees in the event TauroPharm is entitled to reimbursement of these costs. The Company recorded the deposit as restricted cash for the year ended December 31, 2015. The Company furthermore had to provide a deposit in the amount of $40,000 in connection with the unfair competition proceedings in Cologne. These amounts are shown as restricted cash on the condensed consolidated balance sheets. Commitments Clinical and Regulatory In December 2015, the Company entered into a Master Service Agreement and Work Orders (the “Master Service Agreement”) with a clinical research organization (“CRO”) to help the Company conduct its LOCK-IT-100 Phase 3 multicenter, double-blind, randomized active control study 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. During 2018, the Company contested a substantial amount of the unpaid clinical trial expense accrued during 2018 due to the unexpected delay and additional costs the Company incurred in preparing for the interim analysis of the LOCK-IT-100 study. Negotiations with the CRO concluded in November 2018 with the signing of a confidential settlement agreement. In parallel with the settlement agreement, a new work order under the Master Service Agreement was executed specifying certain services the CRO will continue to provide to the Company related to the closeout of the study. The budgeted amount of the new work order is approximately $1.4 million, of which $1.3 million was incurred through June 30, 2019. Through June 30, 2019, approximately $29.2 million of clinical trial expense has been recorded in connection with the Master Service Agreement and new work orders, of which approximately $27.3 million has been paid. During the three and six months ended June 30, 2019, the Company recognized $185,000 and $702,000, respectively, in research and development expense related to the Master Service Agreement and $3,242,000 and $9,040,000 during the three and six months ended June 30, 2018. At June 30, 2019, the Company had accrued $1,710,000 in accounts payable and accrued expenses related to the settlement agreement and the new work order. In-Licensing In 2008, the Company entered into a License and Assignment Agreement (the “NDP License Agreement”) with ND Partners, LLP (“NDP”). Pursuant to the NDP License Agreement, NDP granted the Company exclusive, worldwide licenses for certain antimicrobial catheter lock solutions, processes for treating and inhibiting infections, a biocidal lock system and a taurolidine delivery apparatus, and the corresponding United States and foreign patents and applications (the “NDP Technology”). The Company acquired such licenses and patents through its assignment and assumption of NDP’s rights under certain separate license agreements by and between NDP and Dr. Hans-Dietrich Polaschegg, Dr. Klaus Sodemann and Dr. Johannes Reinmueller. As consideration in part for the rights to the NDP Technology, the Company paid NDP an initial licensing fee of $325,000 and granted NDP a 5% equity interest in the Company, consisting of 7,996 shares of the Company’s common stock. 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 29,109 shares. In 2014, a certain milestone was achieved resulting in the release of 7,277 shares held in escrow. The number of shares held in escrow as of June 30, 2019 and 2018 is 21,832 shares of common stock. The maximum aggregate amount of cash payments due upon achievement of milestones is $3,000,000 with the balance of $2,500,000 for the quarters ended June 30, 2019 and 2018. 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 quarters ended June 30, 2019 and 2018. 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 On March 19, 2019, the Company entered into an employment agreement with Phoebe Mounts, pursuant to which Dr. Mounts became the Company’s Executive Vice President and General Counsel on May 1, 2019. Unless renewed pursuant to the terms thereof, the agreement will expire on March 18, 2022. After the initial three-year term of the 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 Dr. Mounts’ employment, the Company granted her stock options to purchase 70,000 shares of common stock, 42,000 of which vest in four equal installments over four years on the first four anniversaries of the start date, subject to Dr. Mounts’ three-year employment with the Company and 28,000 of which vest upon the achievement of designated milestones. If the Company terminates Dr. Mounts’ employment other than for Cause (as defined in the agreement), death or disability, and other than by notice of nonrenewal, or if she resigns for Good Reason (as defined in the agreement), Dr. Mounts will receive her base salary and benefits for a period of nine months following the effective date of the termination of her employment, and all unvested stock options held by her will be accelerated and deemed to have vested as of the termination date, provided that any milestone option whose vesting requirements have not been met as of the termination date will be terminated.

7. Leases

7. Leases	6 Months Ended
	Jun. 30, 2019
Leases [Abstract]
Leases	The Company entered into an operating lease for office space in Germany that began in July 2017. The rental agreement has a three-month term which automatically renews and includes a monthly cost of 400 Euros. The Company elected to apply the short-term practical expedient to the office lease. The Company also has an operating lease for office equipment. Prior to the adoption of ASC 842, operating lease expense of approximately $2,000 and $4,000 was recognized in the Company’s consolidated statements of operations and comprehensive income (loss) for the three and six months ended June 30, 2018. Operating lease expense in the Company’s consolidated statements of operations and comprehensive income (loss) for the three and six months ended June 30, 2019 was approximately $2,000 and $4,000, which includes costs associated with leases for which right of use (“ROU”) assets have been recognized as well as short-term leases. At June 30, 2019, the Company has a total operating lease liability of $6,000. Approximately $2,000 and $4,000, respectively, are included in accrued expenses and operating lease liabilities, net of current portion on the condensed consolidated balance sheet. Operating ROU assets as of June 30, 2019 are $6,000 and are included in property and equipment, net on the condensed consolidated balance sheet. For the three and six months ended June 30, 2019, cash paid for amounts included in the measurement of lease liabilities in operating cash flows from operating leases was $2,000 and $4,000, respectively. The weighted average remaining lease term and weighted average discount rate for operating leases were 2.5 years and 10.0%, respectively, as of June 30, 2019. As of June 30, 2019, maturities of lease liabilities were as follows: 2019 (excluding the six months ended June 30, 2019) $ 1,000 2020 2,000 2021 2,000 2022 1,000 Total future minimum lease payments 6,000 Less imputed interest (2,000 ) Total $ 4,000

8. Concentrations

8. Concentrations	6 Months Ended
	Jun. 30, 2019
Expected Term, maximum
Concentrations	At June 30, 2019 and December 31, 2018, no net accounts receivable was due from a customer that exceeded 10% of the Company’s accounts receivable. During the three months ended June 30, 2019, the Company had revenue from one customer that exceeded 10% of its totals sales of $35,000 (96%) and for the six months ended June 30, 2019, the Company had revenue from three customers that each exceeded 10% of its total sales of $199,000 (59%, 18% and 17%). During the three months and six months ended June 30, 2018, the Company had revenue from two customers that each exceeded 10% of its total sales (34% and 28%) and (36% and 14%), respectively.

9. Subsequent Events

9. Subsequent Events	6 Months Ended
	Jun. 30, 2019
Subsequent Events [Abstract]
Subsequent Events	On August 14, 2019, the Company entered into an exchange agreement (the “Exchange Agreement”) with certain holders of its outstanding equity securities who collectively beneficially own the largest portion of its common stock (the “Investors”) pursuant to which the Investors agreed to exchange all of their outstanding warrants, the 10% senior secured convertible note and shares of Series C-2 Preferred Stock, Series D Preferred Stock and Series F Preferred Stock, and make a cash payment of $2.0 million, for 100,000 shares of Series G Convertible Preferred Stock, with an aggregate liquidation preference of $18,736,452, which will be convertible into an aggregate of 5,560,138 shares of the Company’s common stock at a conversion price of $3.37 per share . ,

2. Summary of Significant Acc_2

2. Summary of Significant Accounting Policies (Policies)	6 Months Ended
	Jun. 30, 2019
Accounting Policies [Abstract]
Liquidity, Going Concern and Uncertainties	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 June 30, 2019, the Company had an accumulated deficit of $184.9 million, and incurred losses from operations of $0.7 million and $8.6 million for the three months ended June 30, 2019 and 2018, respectively, and $5.9 million and $18.7 million for the six months ended June 30, 2019 and 2018, respectively. The Company currently estimates that as of June 30, 2019 it has sufficient cash on hand to fund operations into the third quarter 2020, including the submission of the NDA for Neutrolin and initial preparations for commercial launch. The company currently anticipates that FDA marketing approval for Neutrolin could be received in the second half of 2020. In April 2019, the Company received approximately $5.1 million, net of expenses, from the sale of a portion of its unused New Jersey net operating losses (“NOL”). The NOL was sold through the State of New Jersey’s Economic Development Authority (“NJEDA”) Technology Business Tax Certificate Transfer program, which allowed the Company to sell approximately $5.4 million of its total $6.1 million in available NOL tax benefits. 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 out-licensing of its products, to commercially launch Neutrolin upon NDA approval, and until profitability is achieved, if ever. Management can provide no assurances that such financing or strategic relationships will be available on acceptable terms, or at all. At the financial reporting date, the Company has approximately $4.6 million available under its current ATM program and $30.3 million available under its current shelf registration for the issuance of equity, debt or equity-linked securities unrelated to the current ATM program. The Company’s operations are subject to a number of other factors that can affect its operating results and financial condition. Such factors include, but are not limited to: the results of clinical testing and trial activities of the Company’s product candidates; the ability to obtain regulatory approval to market the Company’s products; ability to manufacture successfully; competition from products manufactured and sold or being developed by other companies; the price of, and demand for, Company products; the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products; and the Company’s ability to raise capital to support its operations.
Use of Estimates	The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates.
Basis of Consolidation	The condensed consolidated financial statements include the accounts of the Company and CorMedix Europe GmbH, its wholly owned subsidiary. All significant intercompany accounts and transactions have been eliminated in consolidation.
Financial Instruments	Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents and short-term investments. The Company maintains its cash and cash equivalents in bank deposit and other interest-bearing accounts, the balances of which, at times, may exceed federally insured limits. The appropriate classification of marketable securities is determined at the time of purchase and reevaluated as of each balance sheet date. Investments in marketable debt and equity securities classified as available-for-sale are reported at fair value. Fair value is determined using quoted market prices in active markets for identical assets or liabilities or quoted prices for similar assets or liabilities or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Changes in fair value that are considered temporary are reported in the condensed consolidated statement of operations. 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 June 30, 2019 or December 31, 2018. 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 June 30, 2019 and December 31, 2018, all of the Company’s investments had contractual maturities of less than one year. The following table summarizes the amortized cost, unrealized gains and losses and the fair value at June 30, 2019 and December 31, 2018: June 30, 2019: Amortized Cost Gross Unrealized Losses Gross Unrealized Gains Fair Value Money Market Funds and Cash Equivalents $ 3,480,030 $ (236 ) $ - $ 3,479,794 U.S. Government Agency Securities 2,834,818 - 2,085 2,836,903 Corporate Securities 7,593,871 (367 ) 5,050 7,598,554 Commercial Paper 1,387,879 - 1,306 1,389,185 Subtotal 11,816,568 (367 ) 8,441 11,824,642 Total June 30, 2019 $ 15,296,598 $ (603 ) $ 8,441 $ 15,304,436 December 31, 2018: Money Market Funds included in Cash Equivalents $ 1,179,673 $ - $ - $ 1,179,673 Total December 31, 2018 $ 1,179,673 $ - $ - $ 1,179,673
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 June 30, 2019 and December 31, 2018: June 30, 2019: Carrying Value Level 1 Level 2 Level 3 Money Market Funds and Cash Equivalents $ 3,479,794 $ 2,083,007 $ 1,396,787 $ - U.S. Government Agency Securities 2,836,903 2,836,903 - - Corporate Securities 7,598,554 - 7,598,554 - Commercial Paper 1,389,185 - 1,389,185 - Subtotal 11,824,642 2,836,903 8,987,739 $ - Total June 30, 2019 $ 15,304,436 $ 4,919,910 $ 10,384,526 $ - December 31, 2018: Money Market Funds $ 1,179,673 $ 1,179,673 $ - $ - Total December 31, 2018 $ 1,179,673 $ 1,179,673 $ - $ -
Foreign Currency Translation and Transactions	The condensed consolidated financial statements are presented in U.S. Dollars (“USD”), the reporting currency of the Company. For the financial statements of the Company’s foreign subsidiary, whose functional currency is the EURO, foreign currency asset and liability amounts, are translated into USD at end-of-period exchange rates. Foreign currency income and expenses are translated at average exchange rates in effect during the period in which the income and expenses were recognized. Translation gains and losses are included in other comprehensive income (loss). The Company has intercompany loans between the parent company based in New Jersey and its German subsidiary. The intercompany loans outstanding are not expected to be repaid in the foreseeable future and unrealized foreign exchange movements related to long-term intercompany loans are recognized in other comprehensive income (loss). Foreign currency exchange transaction gain (loss) is the result of re-measuring transactions denominated in a currency other than the functional currency of the entity recording the transaction.
Restricted Cash	As of June 30, 2019 and December 31, 2018, the Company has restricted cash in connection with the patent and utility model infringement proceedings against TauroPharm (see Note 6). The Company was required by the District Court Mannheim to provide a security deposit of approximately $132,000 to cover legal fees in the event TauroPharm is entitled to reimbursement of these costs. The Company furthermore had to provide a deposit in the amount of $40,000 in connection with the unfair competition proceedings in Cologne.
Prepaid Research and Development	Prepaid 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 net realizable value on a first in, first out basis. Inventories consist of raw materials (including labeling and packaging), work-in-process, and finished goods, if any, for the Neutrolin product. Inventories consist of the following: June 30, 2019 December 31, 2018 Raw materials $ 6,893 $ 71,275 Work in process 86,437 86,957 Finished goods 412,384 373,283 Inventory reserve (103,000 ) (103,000 ) Total $ 402,714 $ 428,515
Leases	The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets, current portion of operating lease liabilities, and operating lease liabilities, net of current portion, on the consolidated balance sheet. Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. The Company has elected, as an accounting policy, not to apply the recognition requirements in ASC 842 to short-term leases. Short-term leases are leases that have a term of 12 months or less and do not include an option to purchase the underlying asset that the Company is reasonably certain to exercise. The Company recognizes the lease payments for short-term leases on a straight-line basis over the lease term. The Company has also elected, as a practical expedient, by underlying class of asset, not to separate lease components from non-lease components and, instead, account for them as a single component.
Accrued Expenses	Accrued expenses consist of the following: June 30, 2019 December 31, 2018 Professional and consulting fees $ 273,637 $ 258,352 Accrued payroll and payroll taxes 765,941 1,102,143 Clinical trial related 1,749,437 3,408,032 Manufacturing development related 424,427 210,577 Product development 49,200 49,200 Other 171,112 137,920 Total $ 3,433,754 $ 5,166,224
Revenue Recognition	The Company recognizes revenue in accordance with ASC 606, “ Revenue from Contracts with Customers”. The Company recognizes net sales upon shipment of product and upon meeting the five-step model prescribed by ASC 606 outlined above.
Deferred Revenue	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”). Product registration in the Territory is contingent upon the marketing approval of Neutrolin in the U.S. 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 is being recognized as revenue on a straight-line basis over the contractual term of the Agreement. The Company recognized $2,200 of revenue related to the Wonik Agreement for each of the three months ended June 30, 2019 and 2018 and $4,400 for the six months ended June 30, 2019 and 2018, respectively. Deferred revenue related to the Wonik Agreement at June 30, 2019 and December 31, 2018 amounted to approximately $6,600 and $11,000, 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. Six Months Ended June 30, 2019 2018 Series C non-voting preferred stock 408,000 508,000 Series D non-voting preferred stock 295,848 295,848 Series E non-voting preferred stock 391,953 391,953 Series F non-voting preferred stock 2,469,137 2,469,137 Shares issuable upon conversion of convertible debt 1,000,000 - Restricted stock units 13,642 19,506 Shares issuable for payment of deferred board compensation 30,553 24,528 Shares underlying outstanding warrants 3,197,163 4,578,579 Shares underlying outstanding stock options 1,297,793 1,101,159 Total potentially dilutive shares 9,104,089 9,388,710
Stock-Based Compensation	The Company accounts for stock options granted according to ASC No. 718, “Compensation — Stock Compensation”
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 activities and the invoices received from its external service providers. Costs related to the acquisition of technology rights and patents for which development work is still in process are charged to operations as incurred and considered a component of research and development expense.

2. Summary of Significant Acc_3

2. Summary of Significant Accounting Policies (Tables)	6 Months Ended
	Jun. 30, 2019
Accounting Policies [Abstract]
Marketable securities	June 30, 2019: Amortized Cost Gross Unrealized Losses Gross Unrealized Gains Fair Value Money Market Funds and Cash Equivalents $ 3,480,030 $ (236 ) $ - $ 3,479,794 U.S. Government Agency Securities 2,834,818 - 2,085 2,836,903 Corporate Securities 7,593,871 (367 ) 5,050 7,598,554 Commercial Paper 1,387,879 - 1,306 1,389,185 Subtotal 11,816,568 (367 ) 8,441 11,824,642 Total June 30, 2019 $ 15,296,598 $ (603 ) $ 8,441 $ 15,304,436 December 31, 2018: Money Market Funds included in Cash Equivalents $ 1,179,673 $ - $ - $ 1,179,673 Total December 31, 2018 $ 1,179,673 $ - $ - $ 1,179,673
Carrying and fair value of financial assets	June 30, 2019: Carrying Value Level 1 Level 2 Level 3 Money Market Funds and Cash Equivalents $ 3,479,794 $ 2,083,007 $ 1,396,787 $ - U.S. Government Agency Securities 2,836,903 2,836,903 - - Corporate Securities 7,598,554 - 7,598,554 - Commercial Paper 1,389,185 - 1,389,185 - Subtotal 11,824,642 2,836,903 8,987,739 $ - Total June 30, 2019 $ 15,304,436 $ 4,919,910 $ 10,384,526 $ - December 31, 2018: Money Market Funds $ 1,179,673 $ 1,179,673 $ - $ - Total December 31, 2018 $ 1,179,673 $ 1,179,673 $ - $ -
Schedule of inventories	June 30, 2019 December 31, 2018 Raw materials $ 6,893 $ 71,275 Work in process 86,437 86,957 Finished goods 412,384 373,283 Inventory reserve (103,000 ) (103,000 ) Total $ 402,714 $ 428,515
Schedule of accrued expenses	June 30, 2019 December 31, 2018 Professional and consulting fees $ 273,637 $ 258,352 Accrued payroll and payroll taxes 765,941 1,102,143 Clinical trial related 1,749,437 3,408,032 Manufacturing development related 424,427 210,577 Product development 49,200 49,200 Other 171,112 137,920 Total $ 3,433,754 $ 5,166,224
Schedule of anti-dilutive securities excluded from calculation of diluted net loss per share	Six Months Ended June 30, 2019 2018 Series C non-voting preferred stock 408,000 508,000 Series D non-voting preferred stock 295,848 295,848 Series E non-voting preferred stock 391,953 391,953 Series F non-voting preferred stock 2,469,137 2,469,137 Shares issuable upon conversion of convertible debt 1,000,000 - Restricted stock units 13,642 19,506 Shares issuable for payment of deferred board compensation 30,553 24,528 Shares underlying outstanding warrants 3,197,163 4,578,579 Shares underlying outstanding stock options 1,297,793 1,101,159 Total potentially dilutive shares 9,104,089 9,388,710

3. Stockholders' Equity (Tables

3. Stockholders' Equity (Tables)	6 Months Ended
	Jun. 30, 2019
STOCKHOLDERS' EQUITY
Preferred stock	As of June 30, 2019 As of December 31, 2018 Preferred Shares Outstanding Liquidation Preference (Per Share) Total Liquidation Preference Preferred Shares Outstanding Liquidation Preference (Per Share) Total Liquidation Preference Series C-2 150,000 $ 10.00 $ 1,500,000 150,000 $ 10.00 $ 1,500,000 Series C-3 54,000 $ 10.00 $ 540,000 104,000 $ 10.00 $ 1,040,000 Series D 73,962 $ 21.00 $ 1,553,202 73,962 $ 21.00 $ 1,553,202 Series E 89,623 $ 49.20 $ 4,409,452 89,623 $ 49.20 $ 4,409,452 Series F 2,000 $ 1,000.00 $ 2,000,000 2,000 $ 1,000.00 $ 2,000,000 Total 369,585 $ 10,002,654 419,585 $ 10,502,654
Fair value assumptions for Black Sholes	Expected term 4.17 - 10 years Volatility 102.80% - 162.98% Dividend yield 0.0% Risk-free interest rate 2.31% - 2.74% Weighted average grant date fair value of options granted during the period $6.74
Summary of Option Activity under Plan and Related Information	Shares Weighted Average Weighted Average Aggregate Intrinsic Value Outstanding at beginning of period 1,011,267 $ 9.32 6.5 $ 1,897,363 Granted 344,300 $ 7.88 $ 374,061 Forfeited (21,757 ) $ 6.45 $ 54,910 Expired (177 ) $ 3.66 $ 935 Exercised (35,840 ) $ 3.15 $ 208,716 Outstanding at end of period 1,297,793 $ 9.16 7.1 $ 2,006,863 Exercisable at end of period 767,241 $ 9.18 6.0 $ 1,449,328

7. Leases (Tables)

7. Leases (Tables)	6 Months Ended
	Jun. 30, 2019
Leases [Abstract]
Maturities of lease liabilities	2019 (excluding the six months ended June 30, 2019) $ 1,000 2020 2,000 2021 2,000 2022 1,000 Total future minimum lease payments 6,000 Less imputed interest (2,000 ) Total $ 4,000

2. Summary of Significant Acc_4

2. Summary of Significant Accounting Policies (Details 1) - USD ($)	6 Months Ended	12 Months Ended
	Jun. 30, 2019	Dec. 31, 2018
Amortized cost	$ 15,296,598	$ 1,179,673
Gross unrealized losses	(603)	0
Gross unrealized gains	8,441	0
Fair value	15,304,436	1,179,673
Money Market Funds included in Cash Equivalents
Amortized cost	3,480,030	1,179,673
Gross unrealized losses	(236)	0
Gross unrealized gains	0	0
Fair value	3,479,794	1,179,673
U.S. Government Agency Securities
Amortized cost	2,834,818	0
Gross unrealized losses	0	0
Gross unrealized gains	2,085	0
Fair value	2,836,903	0
Corporate Securities
Amortized cost	7,593,871	0
Gross unrealized losses	(367)	0
Gross unrealized gains	5,050	0
Fair value	7,598,554	0
Commercial Paper
Amortized cost	1,387,879	0
Gross unrealized losses	0	0
Gross unrealized gains	1,306	0
Fair value	1,389,185	0
Subtotal
Amortized cost	11,816,568	0
Gross unrealized losses	(367)	0
Gross unrealized gains	8,441	0
Fair value	$ 11,824,642	$ 0

2. Summary of Significant Acc_5

2. Summary of Significant Accounting Policies (Details 2) - USD ($)	Jun. 30, 2019	Dec. 31, 2018
Carrying Value	$ 15,304,436	$ 1,179,673
Level 1
Carrying Value	4,919,910	1,179,673
Level 2
Carrying Value	10,384,526	0
Level 3
Carrying Value	0	0
Money Market Funds included in Cash Equivalents
Carrying Value	3,479,794	1,179,673
Money Market Funds included in Cash Equivalents | Level 1
Carrying Value	2,083,007	1,179,673
Money Market Funds included in Cash Equivalents | Level 2
Carrying Value	1,396,787	0
Money Market Funds included in Cash Equivalents | Level 3
Carrying Value	0	0
U.S. Government Agency Securities
Carrying Value	2,836,903	0
U.S. Government Agency Securities | Level 1
Carrying Value	2,836,903	0
U.S. Government Agency Securities | Level 2
Carrying Value	0	0
U.S. Government Agency Securities | Level 3
Carrying Value	0	0
Corporate Securities
Carrying Value	7,598,554	0
Corporate Securities | Level 1
Carrying Value	0	0
Corporate Securities | Level 2
Carrying Value	7,598,554	0
Corporate Securities | Level 3
Carrying Value	0	0
Commercial Paper
Carrying Value	1,389,185	0
Commercial Paper | Level 1
Carrying Value	0	0
Commercial Paper | Level 2
Carrying Value	1,389,185	0
Commercial Paper | Level 3
Carrying Value	0	0
Subtotal
Carrying Value	11,824,642	0
Subtotal | Level 1
Carrying Value	2,836,903	0
Subtotal | Level 2
Carrying Value	8,987,739	0
Subtotal | Level 3
Carrying Value	$ 0	$ 0

2. Summary of Significant Acc_6

2. Summary of Significant Accounting Policies (Details 3) - USD ($)	Jun. 30, 2019	Dec. 31, 2018
Accounting Policies [Abstract]
Raw materials	$ 6,893	$ 71,275
Work in process	86,437	86,957
Finished goods	412,384	373,283
Inventory reserve	(103,000)	(103,000)
Total	$ 402,714	$ 428,515

2. Summary of Significant Acc_7

2. Summary of Significant Accounting Policies (Details 4) - USD ($)	Jun. 30, 2019	Dec. 31, 2018
Accounting Policies [Abstract]
Professional and consulting fees	$ 273,637	$ 258,352
Accrued payroll and payroll taxes	765,941	1,102,143
Clinical trial related	1,749,437	3,408,032
Manufacturing development related	424,427	210,577
Product development	49,200	49,200
Other	171,112	137,920
Total	$ 3,433,754	$ 5,166,224

2. Summary of Significant Acc_8

2. Summary of Significant Accounting Policies (Details 5) - shares	6 Months Ended
	Jun. 30, 2019	Jun. 30, 2018
Antidilutive Shares	9,104,089	9,388,710
Series C non-voting convertible preferred stock
Antidilutive Shares	408,000	508,000
Series D non-voting convertible preferred stock
Antidilutive Shares	295,848	295,848
Series E non-voting convertible preferred stock
Antidilutive Shares	391,953	391,953
Series F non-voting convertible preferred stock
Antidilutive Shares	2,469,137	2,469,137
Shares issuable upon conversion of convertible debt
Antidilutive Shares	1,000,000	0
Shares underlying restricted stock units
Antidilutive Shares	13,642	19,506
Shares issuable for payment of deferred board compensation
Antidilutive Shares	30,553	24,528
Shares underlying outstanding warrants
Antidilutive Shares	3,197,163	4,578,579
Shares underlying outstanding stock options
Antidilutive Shares	1,297,793	1,101,159

2. Summary of Significant Acc_9

2. Summary of Significant Accounting Policies (Details Narrative) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2019	Jun. 30, 2018	Jun. 30, 2019	Jun. 30, 2018	Dec. 31, 2018
Accounting Policies [Abstract]
Accumulated deficit	$ (184,852,140)		$ (184,852,140)		$ (178,988,098)
Loss from Operations	(5,537,356)	$ (8,572,150)	(10,460,537)	$ (18,760,973)
Deferred revenue	6,600		6,600		$ 11,000
Deferred revenue recognized	$ 2,200	$ 2,200	$ 4,400	$ 4,400

3. Stockholders' Equity (Detail

3. Stockholders' Equity (Details) - USD ($)	Jun. 30, 2019	Dec. 31, 2018
Preferred shares outstanding	369,585	419,585
Total Liquidation Preference	$ 10,002,654	$ 10,502,654
Series C-2
Preferred shares outstanding	150,000	150,000
Liquidation Preference (Per Share)	$ 10	$ 10
Total Liquidation Preference	$ 1,500,000	$ 1,500,000
Series C-3
Preferred shares outstanding	54,000	104,000
Liquidation Preference (Per Share)	$ 10	$ 10
Total Liquidation Preference	$ 540,000	$ 1,040,000
Series D
Preferred shares outstanding	73,962	73,962
Liquidation Preference (Per Share)	$ 21	$ 21
Total Liquidation Preference	$ 1,553,202	$ 1,553,202
Series E
Preferred shares outstanding	89,623	89,623
Liquidation Preference (Per Share)	$ 49.20	$ 49.20
Total Liquidation Preference	$ 4,409,452	$ 4,409,452
Series F
Preferred shares outstanding	2,000	2,000
Liquidation Preference (Per Share)	$ 1,000	$ 1,000
Total Liquidation Preference	$ 2,000,000	$ 2,000,000

3. Stockholders' Equity (Deta_2

3. Stockholders' Equity (Details 1)	6 Months Ended
	Jun. 30, 2019$ / shares
STOCKHOLDERS' EQUITY
Expected term, minimum	4 years 2 months 1 day
Expected term, maximum	10 years
Volatility, minimum	102.80%
Volatility, maximum	162.98%
Dividend yield	0.00%
Risk-free interest rate, minimum	2.31%
Risk-free interest rate, maximum	2.74%
Weighted-average fair value of options granted during the period	$ 6.74

3. Stockholders' Equity (Deta_3

3. Stockholders' Equity (Details 2)	6 Months Ended
	Jun. 30, 2019USD ($)$ / sharesshares
STOCKHOLDERS' EQUITY
Number of Options Outstanding, Beginning | shares	1,011,267
Number of Options Granted | shares	344,300
Number of Options Forfeited | shares	(21,757)
Number of Options Expired | shares	(177)
Number of Options Exercised | shares	(35,840)
Number of Options Outstanding, Ending | shares	1,297,793
Number of Options Exercisable | shares	767,241
Weighted Average Exercise Price Outstanding, Beginning	$ 9.32
Weighted Average Exercise Price Granted	7.88
Weighted Average Exercise Price Forfeited	6.45
Weighted Average Exercise Price Expired	3.66
Weighted Average Exercise Price Exercised	3.15
Weighted Average Exercise Price Outstanding, Ending	9.16
Weighted Average Exercise Price Exercisable	$ 9.18
Weighted Average Remaining Contractual Life (in years) Outstanding, Beginning	6 years 6 months
Weighted Average Remaining Contractual Life (in years) Outstanding, Ending	7 years 1 month 6 days
Weighted Average Remaining Contractual Life (in years), Exercisable	6 years
Aggregate Intrinsic Value Outstanding, Beginning | $	$ 1,897,363
Aggregate Intrinsic Value, Granted	$ 374,061
Aggregate Intrinsic Value, Forfeited	54,910
Aggregate Intrinsic Value, Expired	$ 935
Aggregate Intrinsic Value, Exercised | $	$ 208,716
Aggregate Intrinsic Value Outstanding, Ending | $	2,006,863
Aggregate Intrinsic Value, Exercisable | $	$ 1,449,328

3. Stockholders' Equity (Deta_4

3. Stockholders' Equity (Details Narrative) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2019	Jun. 30, 2018	Jun. 30, 2019	Jun. 30, 2018
Stock-based compensation for stock options issued	$ 557,000	$ 337,000	$ 1,317,000	$ 687,000
Unrecognized compensation expense	$ 2,520,000		$ 2,520,000
Warrants, weighted average remaining contractual life			2 years 7 months 6 days
Warrants, weighted average exercise price per share	$ 5.50		$ 5.50
Intrinsic value of stock options exercised			$ 208,716
Outstanding warrants			3,197,163
Restricted Stock Unit
Compensation expense	$ 49,000	$ 21,000	$ 99,000	$ 44,000
Unrecognized compensation expense	$ 98,000		$ 98,000

6. Commitments and Contingenc_2

6. Commitments and Contingencies (Details Narrative) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2019	Jun. 30, 2018	Jun. 30, 2019	Jun. 30, 2018
Commitments and Contingencies Disclosure [Abstract]
Research and development expense - clinical and regulatory	$ 185,000	$ 3,242,000	$ 702,000	$ 9,040,000

7. Leases (Details)

7. Leases (Details)	Jun. 30, 2019USD ($)
Leases [Abstract]
2019 (excluding the six months ended June 30, 2019)	$ 1,000
2020	2,000
2021	2,000
2022	1,000
Total future minimum lease payments	6,000
Less imputed interest	(2,000)
Total	$ 4,000

8. Concentrations (Details Narr

8. Concentrations (Details Narrative) - Revenue	3 Months Ended		6 Months Ended
	Jun. 30, 2019	Jun. 30, 2018	Jun. 30, 2019	Jun. 30, 2018
Customer A
Concentration risk	96.00%	34.00%	59.00%	36.00%
Customer B
Concentration risk		28.00%	18.00%	14.00%
Customer C
Concentration risk			17.00%