Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2019 | Nov. 12, 2019 | |
Document and Entity Information [Abstract] | ||
Entity Registrant Name | CorMedix Inc. | |
Entity Central Index Key | 0001410098 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2019 | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2019 | |
Entity Current reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity shell Company | false | |
Entity Emerging Growth Company | false | |
Entity Ex Transition Period | false | |
Entity File Number | 001-34673 | |
Entity Interactive Data Current | Yes | |
Entity Incorporation State Country Code | DE | |
Entity Common Stock, Shares Outstanding | 25,652,625 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 |
Current assets | ||
Cash and cash equivalents | $ 20,145,052 | $ 17,623,770 |
Restricted cash | 170,294 | 171,553 |
Short-term investments | 12,294,290 | |
Trade receivables | 3,956 | 10,904 |
Inventories, net | 381,065 | 428,515 |
Prepaid research and development expenses | 61,607 | 8,113 |
Other prepaid expenses and current assets | 526,684 | 422,199 |
Total current assets | 33,582,948 | 18,665,054 |
Property and equipment, net | 134,515 | 160,860 |
TOTAL ASSETS | 33,717,463 | 18,825,914 |
Current liabilities | ||
Accounts payable | 1,054,971 | 2,588,977 |
Accrued expenses | 3,947,218 | 5,166,224 |
Deferred revenue | 4,411 | 11,029 |
Total current liabilities | 5,006,600 | 7,766,230 |
Operating lease liabilities, net of current portion | 3,088 | |
Convertible note, related party, net | 6,125,428 | |
TOTAL LIABILITIES | 5,009,688 | 13,891,658 |
COMMITMENTS AND CONTINGENCIES | ||
STOCKHOLDERS' EQUITY | ||
Preferred stock - $0.001 par value: 2,000,000 shares authorized; 243,623 and 419,585 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively | 244 | 420 |
Common stock - $0.001 par value: 160,000,000 shares authorized; 25,650,429 and 21,775,173 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively | 25,651 | 21,775 |
Accumulated other comprehensive income | 102,001 | 96,522 |
Additional paid-in capital | 218,696,866 | 183,803,637 |
Accumulated deficit | (190,116,987) | (178,988,098) |
TOTAL STOCKHOLDERS' EQUITY | 28,707,775 | 4,934,256 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ 33,717,463 | $ 18,825,914 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Sep. 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 | 243,623 | 419,585 |
Preferred stock, shares outstanding | 243,623 | 419,585 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 160,000,000 | 160,000,000 |
Common stock, shares issued | 25,650,429 | 21,775,173 |
Common stock, shares outstanding | 25,650,429 | 21,775,173 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Revenue: | ||||
Net sales | $ 59,530 | $ 372,514 | $ 258,488 | $ 403,274 |
Cost of sales | (79,026) | (312,434) | (327,109) | (374,672) |
Gross profit (loss) | (19,496) | 60,080 | (68,621) | 28,602 |
Operating Expenses: | ||||
Research and development | (2,520,992) | (8,289,094) | (8,375,896) | (23,169,750) |
Selling, general and administrative | (2,631,027) | (2,012,439) | (7,187,535) | (5,861,279) |
Total Operating Expenses | (5,152,019) | (10,301,533) | (15,563,431) | (29,031,029) |
Loss From Operations | (5,171,515) | (10,241,453) | (15,632,052) | (29,002,427) |
Other Income (Expense): | ||||
Interest income | 92,094 | 5,411 | 246,880 | 30,383 |
Foreign exchange transaction loss | (12,997) | (77) | (23,283) | (4,230) |
Interest expense, including amortization of debt discount | (172,429) | (781,212) | (1,873) | |
Total Other Income (Expense) | (93,332) | 5,334 | (557,615) | 24,280 |
Loss before income taxes | (5,264,847) | (10,236,119) | (16,189,667) | (28,978,147) |
Tax benefit | 5,060,778 | |||
Net Loss | (5,264,847) | (10,236,119) | (11,128,889) | (28,978,147) |
Other Comprehensive Income (Loss): | ||||
Unrealized (loss) gain from investments | (3,125) | 4,714 | ||
Foreign currency translation gain (loss) | 786 | (6,405) | 765 | (7,435) |
Total Other Comprehensive Income (Loss) | (2,339) | (6,405) | 5,479 | (7,435) |
Comprehensive Loss | (5,267,186) | (10,242,524) | (11,123,410) | (28,985,582) |
Net Loss | (5,264,847) | (10,236,119) | (11,128,889) | (28,978,147) |
Deemed dividend as a result of warrant modification | (369,500) | (369,500) | ||
Deemed dividend as a result of exchange of convertible note and Series C-2, D and F preferred stock, related party | (26,733,098) | (26,733,098) | ||
Net Loss Attributable to Common Shareholders | $ (32,367,445) | $ (10,236,119) | $ (38,231,487) | $ (28,978,147) |
Net Loss Per Common Share - Basic and Diluted | $ (1.35) | $ (0.54) | $ (1.62) | $ (1.73) |
Weighted Average Common Shares Outstanding - Basic and Diluted | 24,015,927 | 18,831,317 | 23,642,033 | 16,780,833 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) - USD ($) | Common Stock | Preferred Stock - Series C-3, Series E and Series G | Accumulated Other Comprehensive Income (Loss) | Additional Paid-In Capital | Accumulated Deficit | Total |
Balance at Dec. 31, 2017 | $ 14,283 | $ 420 | $ 98,433 | $ 159,255,081 | $ (152,174,866) | $ 7,193,351 |
Balance ,Shares at Dec. 31, 2017 | 14,282,758 | 419,585 | ||||
Stock issued in connection with ATM sale of common stock, net | $ 5,448 | 11,007,199 | 11,012,647 | |||
Stock issued in connection with ATM sale of common stock, net, Shares | 5,448,451 | |||||
Issuance of vested restricted stock | $ 9 | (9) | ||||
Issuance of vested restricted stock, Shares | 8,677 | |||||
Stock issued for payment of deferred fees | $ 25 | 173,748 | 173,773 | |||
Stock issued for payment of deferred fees, Shares | 25,526 | |||||
Stock-based compensation | 1,091,613 | 1,091,613 | ||||
Cumulative effect of adoption of ASC 606 | 16,624 | 16,624 | ||||
Other comprehensive loss | (7,435) | (7,435) | ||||
Net loss | (28,978,147) | (28,978,147) | ||||
Balance at Sep. 30, 2018 | $ 19,765 | $ 420 | 90,998 | 171,527,632 | (181,136,389) | (9,497,574) |
Balance, Shares at Sep. 30, 2018 | 19,765,412 | 419,585 | ||||
Balance at Jun. 30, 2018 | $ 17,004 | $ 420 | 97,403 | 164,307,314 | (170,900,158) | (6,478,017) |
Balance ,Shares at Jun. 30, 2018 | 17,003,848 | 419,585 | ||||
Stock issued in connection with ATM sale of common stock, net | $ 2,761 | 6,860,173 | 6,862,934 | |||
Stock issued in connection with ATM sale of common stock, net, Shares | 2,761,564 | |||||
Stock-based compensation | 360,145 | 360,145 | ||||
Cumulative effect of adoption of ASC 606 | (112) | (112) | ||||
Other comprehensive loss | (6,405) | (6,405) | ||||
Net loss | (10,236,119) | (10,236,119) | ||||
Balance at Sep. 30, 2018 | $ 19,765 | $ 420 | 90,998 | 171,527,632 | (181,136,389) | (9,497,574) |
Balance, Shares at Sep. 30, 2018 | 19,765,412 | 419,585 | ||||
Balance at Dec. 31, 2018 | $ 21,775 | $ 420 | 96,522 | 183,803,637 | (178,988,098) | 4,934,256 |
Balance ,Shares at Dec. 31, 2018 | 21,775,173 | 419,585 | ||||
Stock issued in connection with ATM sale of common stock, net | $ 1,768 | 15,232,761 | 15,234,529 | |||
Stock issued in connection with ATM sale of common stock, net, Shares | 1,768,012 | |||||
Issuance of vested restricted stock | $ 19 | (19) | ||||
Issuance of vested restricted stock, Shares | 19,425 | |||||
Stock issued in connection with warrants exercised | $ 1,945 | 8,656,288 | 8,658,233 | |||
Stock issued in connection with warrants exercised, shares | 1,944,707 | |||||
Exchange of convertible note for Series G preferred Stock, related party | 8,900,264 | 8,900,264 | ||||
Exchange of Series C-2, Series D and Series F preferred stock for Series G preferred stock, related party | $ (226) | 226 | ||||
Exchange of Series C-2, Series D and Series F preferred stock for Series G preferred stock, related party, Shares | (225,962) | |||||
Issuance of Series G preferred stock, related party | $ 100 | 100 | ||||
Issuance of Series G preferred stock, related party, Shares | 100,000 | |||||
Stock issued in connection with stock options exercised | $ 37 | 117,492 | 117,529 | |||
Stock issued in connection with stock options exercised, shares | 36,590 | |||||
Conversion of Series C-3 non-voting preferred stock to common stock | $ 100 | $ (50) | (50) | |||
Conversion of Series C-3 non-voting preferred stock to common stock, shares | 100,000 | (50,000) | ||||
Reversal of common stock issued as a result of reverse stock split rounding | $ 7 | (7) | ||||
Reversal of common stock issued as a result of reverse stock split rounding, Shares | 6,522 | |||||
Stock-based compensation | 1,986,274 | 1,986,274 | ||||
Other comprehensive loss | 5,479 | 5,479 | ||||
Net loss | (11,128,889) | (11,128,889) | ||||
Balance at Sep. 30, 2019 | $ 25,651 | $ 244 | 102,001 | 218,696,866 | (190,116,987) | 28,707,775 |
Balance, Shares at Sep. 30, 2019 | 25,650,429 | 243,623 | ||||
Balance at Jun. 30, 2019 | $ 23,821 | $ 370 | 104,340 | 201,198,660 | (184,852,140) | 16,475,051 |
Balance ,Shares at Jun. 30, 2019 | 23,820,334 | 369,585 | ||||
Issuance of vested restricted stock | $ 6 | (6) | ||||
Issuance of vested restricted stock, Shares | 6,483 | |||||
Stock issued in connection with warrants exercised | $ 1,823 | 8,022,348 | 8,024,171 | |||
Stock issued in connection with warrants exercised, shares | 1,822,862 | |||||
Exchange of convertible note for Series G preferred Stock, related party | 8,900,264 | 8,900,264 | ||||
Exchange of Series C-2, Series D and Series F preferred stock for Series G preferred stock, related party | $ (226) | 226 | ||||
Exchange of Series C-2, Series D and Series F preferred stock for Series G preferred stock, related party, Shares | (225,962) | |||||
Issuance of Series G preferred stock, related party | $ 100 | 100 | ||||
Issuance of Series G preferred stock, related party, Shares | 100,000 | |||||
Stock issued in connection with stock options exercised | $ 1 | 4,762 | 4,763 | |||
Stock issued in connection with stock options exercised, shares | 750 | |||||
Stock-based compensation | 570,612 | 570,612 | ||||
Other comprehensive loss | (2,339) | (2,339) | ||||
Net loss | (5,264,847) | (5,264,847) | ||||
Balance at Sep. 30, 2019 | $ 25,651 | $ 244 | $ 102,001 | $ 218,696,866 | $ (190,116,987) | $ 28,707,775 |
Balance, Shares at Sep. 30, 2019 | 25,650,429 | 243,623 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (11,128,889) | $ (28,978,147) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 1,986,274 | 1,091,613 |
Amortization of debt discount | 313,097 | |
Non-cash interest expense | 461,839 | |
Depreciation | 56,568 | 56,791 |
Changes in operating assets and liabilities: | ||
Decrease (increase) in trade receivables | 6,634 | (247,317) |
Decrease in inventory | 45,010 | 253,017 |
Increase in prepaid expenses and other current assets | (155,484) | (157,694) |
(Decrease) increase in accounts payable | (1,533,649) | 6,074,905 |
(Decrease) increase in accrued expenses | (1,212,100) | 5,481,382 |
Decrease in deferred revenue | (6,618) | (74,964) |
Net cash (used in) operating activities | (11,167,318) | (16,500,414) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of short-term investments | (13,716,503) | |
Maturity of short-term investments | 1,426,927 | 1,604,198 |
Purchase of equipment | (27,142) | (48,893) |
Net cash (used in) provided by investing activities | (12,316,718) | 1,555,305 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from sale of common stock from at-the-market program | 15,234,529 | 11,012,647 |
Proceeds from exercise of warrants | 8,658,233 | |
Proceeds from exchange agreement, related party | 2,000,000 | |
Proceeds from exercise of stock options | 117,529 | |
Net cash provided by financing activities | 26,010,291 | 11,012,647 |
Foreign exchange effect on cash | (6,232) | (3,399) |
NET INCREASE (DECREASE) IN CASH | 2,520,023 | (3,935,861) |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH - BEGINNING OF PERIOD | 17,795,323 | 10,551,282 |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH - END OF PERIOD | 20,315,346 | 6,615,421 |
Cash paid for interest | 6,276 | 1,873 |
Supplemental Disclosure of Non-Cash Financing Activities: | ||
Deemed dividend as a result of warrant modification | 369,500 | |
Deemed dividend as a result of exchange of convertible note, Series C-2, Series D and Series F convertible preferred stock, related party | 26,733,098 | |
Conversion of preferred stock to common stock | 50 | |
Issuance of common stock for payment of deferred fees | 173,773 | |
Right-of-use assets obtained in exchange for lease liability | 5,000 | |
Issuance of common stock for vested restricted stock units | $ 19 | $ 9 |
Organization, Business and Basi
Organization, Business and Basis of Presentation | 9 Months Ended |
Sep. 30, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization, Business and Basis of Presentation | Note 1 — 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 ("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 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 that 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, FDA will review the data in LOCK-IT-100 as submitted in a New Drug Application ("NDA") to determine whether a single study will provide adequate support for the safe and effective use of Neutrolin in hemodialysis patients and the Company believes it is not required to conduct a second Phase 3 clinical trial prior to submission of the NDA. FDA has agreed that the Neutrolin NDA is eligible for priority review and for submission under rolling review, and approval under the Limited Population Pathway for Antibacterial and Antifungal Drugs "LPAD") can be requested. The Company also has had discussions with the FDA on the chemistry, manufacturing and controls ("CMC") package that will be needed to support Neutrolin's NDA. No further CMC meetings with the FDA are planned prior to the NDA submission. 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 consolidated 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 ("Common Stock"), 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. All issued and outstanding share and per share amounts included in the accompanying condensed consolidated financial statements and in this report have been adjusted to reflect the reverse stock split, reclassification, combination and change for all periods presented. On August 14, 2019, the Company entered into an exchange agreement (the "Exchange Agreement") with Manchester Securities Corp. ("Manchester"), a wholly owned subsidiary of Elliott Associates, L.P. (together with Manchester, "Elliott"), who collectively beneficially own the largest portion of the Company's Common Stock pursuant to which Elliott agreed to exchange all of its outstanding warrants, its 10% senior secured convertible note and its 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 to the Company, for 100,000 shares of Series G Preferred Stock (see Note 3). This transaction closed on September 6, 2019. 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 condensed 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 condensed consolidated financial statements. In February 2016, the FASB issued new guidance related to how an entity should recognize 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 $5,000 and $3,000 respectively. Adoption of the standard did not have a material impact on the Company's condensed consolidated statements of operations and comprehensive loss or cash from or used in operating, investing or financing activities on its condensed consolidated statements of cash flows. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 2 — 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 September 30, 2019, the Company had an accumulated deficit of $190.1 million, and incurred losses from operations of $5.3 million and $10.2 million for the three months ended September 30, 2019 and 2018, respectively, and $11.1 million and $29.0 million for the nine months ended September 30, 2019 and 2018, respectively. The Company currently estimates that as of September 30, 2019 it has sufficient cash, cash equivalents and short-term investments on hand to fund operations into the first quarter of 2021, 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 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. On September 6, 2019, the Company received gross proceeds of approximately $2.0 million as a result of the Exchange Agreement with Elliott (see Note 3). On September 25, 2019, the Company received net proceeds of approximately $4.9 million as a result of agreements it entered into with several holders (each a "Holder") of several Series B Warrants ("Series B Warrants") that the Company had issued on May 3, 2017, and amended on September 20, 2019 (each, a "Letter Agreement"). Pursuant to each Letter Agreement, the Company agreed to reduce the exercise price of each Holder's Series B Warrants from $5.25 to $4.00, provided that the Holder exercised its Series B Warrants for cash at the time of entry into such Letter Agreement. Each Holder exercised its Series B Warrants in full and the Company issued an aggregate of 1,224,263 shares of Common Stock to them. As a result of the modification of the exercise price of these warrants, the Company recognized an incremental value of $369,500, which was recorded as a deemed dividend on the condensed consolidated statement of operations and comprehensive loss (see Note 3). 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 statement 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 September 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 September 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 September 30, 2019 and December 31, 2018: Amortized Cost Gross Unrealized Losses Gross Unrealized Gains Fair Value September 30, 2019: Money Market Funds and Cash Equivalents $ 3,093,197 $ (78 ) $ - $ 3,093,119 U.S. Government Agency Securities 2,987,985 - 785 2,988,770 Corporate Securities 6,559,563 (301 ) 3,841 6,563,103 Commercial Paper 2,741,950 (76 ) 543 2,742,417 Subtotal 12,289,498 (377 ) 5,169 12,294,290 Total September 30, 2019 $ 15,382,695 $ (455 ) $ 5,169 $ 15,387,409 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 condensed consolidated balance sheets include cash and cash equivalents, accounts receivable, investment securities, accounts payable and accrued expenses. The carrying value of certain financial instruments, primarily cash and cash equivalents, accounts receivable, accounts payable, and accrued expenses approximate their estimated fair values based upon the short-term nature of their maturity dates. The Company categorizes its financial instruments into a three-level fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets (Level 1) and the lowest priority to unobservable inputs (Level 3). If the inputs used to measure fair value fall within different levels of the hierarchy, the category level is based on the lowest priority level input that is significant to the fair value measurement of the instrument. Financial assets recorded at fair value on the Company's condensed consolidated balance sheets are categorized as follows: ● Level 1 inputs—Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets. ● Level 2 inputs— Significant other observable inputs (e.g., quoted prices for similar items in active markets, quoted prices for identical or similar items in markets that are not active, inputs other than quoted prices that are observable such as interest rate and yield curves, and market-corroborated inputs). ● Level 3 inputs—Unobservable inputs for the asset or liability, which are supported by little or no market activity and are valued based on management's estimates of assumptions that market participants would use in pricing the asset or liability. The following table provides the carrying value and fair value of the Company's financial assets measured at fair value on a recurring basis as of September 30, 2019 and December 31, 2018: Carrying Value Level 1 Level 2 Level 3 September 30, 2019: Money Market Funds and Cash Equivalents $ 3,093,119 $ 2,044,578 $ 1,048,541 $ - U.S. Government Agency Securities 2,988,770 2,988,770 - - Corporate Securities 6,563,103 - 6,563,103 - Commercial Paper 2,742,417 - 2,742,417 - Subtotal 12,294,290 2,988,770 9,305,520 $ - Total September 30, 2019 $ 15,387,409 $ 5,033,348 $ 10,354,061 $ - 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 September 30, 2019 and December 31, 2018, the Company has restricted cash in connection with the patent and utility model infringement and unfair competition proceedings against TauroPharm (see Note 6). The Company was required by the District Courts of Mannheim and Cologne to provide security deposits of an aggregate of approximately $170,000 to cover legal fees in the event TauroPharm is entitled to reimbursement of these costs. 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: September 30, December 31, Raw materials $ 6,893 $ 71,275 Work in process - 86,957 Finished goods 477,172 373,283 Inventory reserve (103,000 ) (103,000 ) Total $ 381,065 $ 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 condensed 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: September 30, December 31, Professional and consulting fees $ 360,814 $ 258,352 Accrued payroll and payroll taxes 1,055,454 1,102,143 Clinical trial related 1,703,825 3,408,032 Manufacturing development related 653,143 210,577 Product development - 49,200 Other 173,982 137,920 Total $ 3,947,218 $ 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 September 30, 2019 and 2018 and $6,600 for the nine months ended September 30, 2019 and 2018, respectively. Deferred revenue related to the Wonik Agreement at September 30, 2019 and December 31, 2018 amounted to approximately $4,400 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. Nine Months Ended 2019 2018 (Number of Shares of Series C-3 non-voting preferred stock 108,000 508,000 Series D non-voting preferred stock - 295,848 Series E non-voting preferred stock 391,953 391,952 Series F non-voting preferred stock - 2,469,136 Series G non-voting preferred stock 5,560,137 - Restricted stock units 8,411 19,506 Shares issuable for payment of deferred board compensation 31,498 - Shares underlying outstanding warrants 344,828 1,097,102 Shares underlying outstanding stock options 1,435,110 3,717,478 Total potentially dilutive shares 7,879,937 8,499,022 Stock-Based Compensation Share-based compensation cost for stock options granted to employees is measured at grant date, based on the estimated fair value of the award using the Black-Scholes option pricing model for options with service or performance-based conditions and is recognized as expense over the employee's requisite service period on a straight-line basis. The Company accounts for stock options granted to non-employees on a fair value basis using the Black-Scholes option pricing model in accordance with ASC No. 718, "Compensation-Stock Compensation" "Equity-Based Payments to Non-Employees" Research and Development Research and development costs are charged to expense as incurred. Research and development includes fees associated with operational consultants, contract clinical research organizations, contract manufacturing organizations, clinical site fees, contract laboratory research organizations, contract central testing laboratories, licensing activities, and allocated executive, human resources and facilities expenses. The Company accrues for costs incurred as the services are being provided by monitoring the status of the 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. |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2019 | |
Stockholders Equity [Abstract] | |
Stockholders' Equity | Note 3 — 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 such as the number or dollar amount of shares registered under the registration statement to which the offering relates and subject to B. Riley's acceptance. B. Riley is entitled to a commission of up to 3% of the gross proceeds from the sale of shares of common stock sold under the ATM program. During the nine months ended September 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 September 30, 2019. At September 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 statement for the issuance of equity, debt or equity-linked securities unrelated to the current ATM program. 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 September 30, 2019 As of December 31, 2018 Preferred Shares Outstanding Liquidation Preference Total Liquidation Preference Preferred Shares Outstanding Liquidation Preference Total Liquidation Preference Series C-2 - - - 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 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 Series G 100,000 $ 187.36 $ 18,736,452 - - - Total 243,623 $ 23,685,904 419,585 $ 10,502,654 On November 9, 2017, the Company entered into a securities purchase agreement which, on November 16, 2017, resulted in the Company selling $2.0 million of its Series F preferred stock ("Series F Stock") at $1,000 per share. Based on the terms of the Series F Stock, the conversion price was initially set at $0.162. The conversion price of the Series F Stock was 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 did 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. All outstanding shares of Series F Stock were cancelled in connection with the terms of the Exchange Agreement, as described below. On August 14, 2019, the Company entered into the Exchange Agreement with Elliott, pursuant to which Elliott agreed to exchange all of its outstanding warrants, its 10% senior secured convertible note and its 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 to the Company, for 100,000 shares of Series G Preferred Stock, with an aggregate liquidation preference of $18,736,452, which are convertible into an aggregate of 5,560,138 shares of the Company's common stock at a conversion price of $3.37 per share. Elliott retained the shares of the Company's common stock and Series E Preferred Stock that it held at the time of the consummation of the Exchange Agreement. Other than with respect to conversion price and liquidation preference, the Series G Preferred Stock has substantially the same terms as the Company's outstanding Series E Preferred Stock, including the restrictive covenants contained therein as modified as set forth in the Exchange Agreement. However, Elliott is prohibited from converting the Series G Preferred Stock into shares of the Company's common stock to the extent that, as a result of such conversion, Elliott would own more than 4.99% of the total number of shares of the Company's common stock then issued and outstanding. The shares of Series G Preferred Stock are entitled to vote on an as-converted basis with respect to the number of shares of common stock into which they are convertible, based upon an assumed conversion price, solely for the purpose of the voting rights, equal to $7.93, the closing price of the Company's common stock on August 14, 2019, and the Series E Preferred Stock was modified to provide for similar rights to vote on an as-converted basis. The Company filed the Certificate of Designation of the Series G Preferred Stock and the Second Amended and Restated Certificate of Designation of the Series E Preferred Stock with the Secretary of State of the State of Delaware on September 5, 2019. On September 6, 2019, the Company closed this transaction and issued the Series G Preferred Stock. Pursuant to the terms of the Exchange Agreement, the exchange of the Series C-2 Preferred Stock, Series D Preferred Stock, Series F Preferred Stock and the 10% senior secured convertible note was considered an extinguishment. As a result, the difference between the fair value allocated to the Series G Preferred Stock and the carrying value of the Series C-2 Preferred Stock, Series D Preferred Stock, Series F Preferred Stock and the 10% senior secured convertible note is being treated as a deemed dividend and is added to net loss to arrive at loss available to common stockholders. The Series G Preferred Stock was valued using the Black Scholes option pricing model. The Black-Scholes option pricing model was also used to determine the fair value of the warrants and the Series C-2 Preferred Stock, Series D Preferred Stock and Series F Preferred Stock. These fair values, along with the fair value of the 10% senior secured convertible note were utilized to allocate the fair value of the Series G Preferred Stock based on relative fair values. ASC 820, Fair Value Measurements, states that the reporting entity should use the valuation technique(s) appropriate for the measurement, considering the availability of data with which to develop inputs that represent the assumptions that market participants would use when pricing the asset or liability. Market participants price options based on expected volatility, not historical volatility. In estimating, the expected volatility of the Company's common stock followed the guidance of ASC 820 and considered a number of factors - including the implied volatility of the Company's listed warrant contracts. A summary of the assumptions used in the Black Scholes pricing model are as follows: Expected term, years 3.0 Volatility 93.3 % Dividend yield 0.0 % Risk-free interest rate 1.53 % As a result of the Exchange Agreement, the Company recognized a deemed dividend of $26,733,098. The deemed dividend was comprised of (1) a beneficial conversion related to the 10% secured senior convertible note recognized at extinguishment; (2) the difference between the allocated fair value of the Series G Preferred Stock issued and the carrying values of the 10% secured senior convertible note, the Series C-2 Preferred Stock, Series D Preferred Stock and Series F Preferred Stock; (3) the difference between the fair value of the exchanged warrants before and after the Exchange Agreement; and (4) the difference between the fair value and the carrying value of Series E Preferred Stock, less the fair value of the Series E warrants that were cancelled as part of the Exchange Agreement. During the nine months ended September 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. Stock Options During the nine months ended September 30, 2019, the Company granted ten-year qualified and non-qualified stock options covering an aggregate of 493,300 shares of the Company's common stock under the 2013 Stock Incentive Plan. The weighted average exercise price of these options is $7.65 per share. During the nine months ended September 30, 2019, the Company issued an aggregate of 36,590 shares of its common stock upon exercise of stock options, resulting in net proceeds of $118,000. During the three and nine months ended September 30, 2019, total compensation expense for stock options issued to employees, directors, officers and consultants was $593,000 and $1,909,000, respectively, and $339,000 and $1,026,000 for the three and nine months ended September 30, 2018, respectively. As of September 30, 2019, there was $2,770,000 in total unrecognized compensation expense related to stock options granted, which expense will be recognized over an expected remaining weighted average period of 1.65 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 nine months ended September 30, 2019: Expected term, years 4.17 - 10 Volatility 102.8% - 104.22% Dividend yield 0.0% Risk-free interest rate 1.52% - 2.74% Weighted average grant date fair value of options granted during the period $6.71 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 nine months ended September 30, 2019: Shares Weighted Average Weighted Average Aggregate Intrinsic Value Outstanding at beginning of period 1,011,267 $ 9.32 6.5 $ 983,353 Granted 493,300 $ 7.65 $ 82,824 Forfeited (32,690 ) $ 6.45 $ 41,137 Expired (177 ) $ 3.66 $ 530 Exercised (36,590 ) $ 3.21 $ 115,913 Outstanding at end of period 1,435,110 $ 8.97 7.1 $ 908,597 Exercisable at end of period 788,031 $ 9.16 5.8 $ 719,160 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 nine months ended September 30, 2018. Restricted Stock Units During the nine months ended September 30, 2019, the Company granted an aggregate of 24,850 restricted stock units ("RSUs") to its directors under its 2013 Stock Incentive Plan with a weighted average grant date fair value of $8.33 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 nine months ended September 30, 2019, the Company issued an aggregate of 19,425 shares of its common stock upon the vesting of RSUs issued to the Company's board of directors. During the three and nine months ended September 30, 2019, compensation expense recorded for the RSUs was $52,000 and $151,000, respectively, and $21,000 and $65,000 for the three and nine months ended September 30, 2018, respectively. Unrecognized compensation expense for these RSUs amounted to $57,000. The expected weighted average period for the expense to be recognized is 0.22 years. Warrants On September 25, 2019, the Company entered into Letter Agreements with Holders of Series B Warrants. Pursuant to each Letter Agreement, the Company agreed to reduce the exercise price of each Holder's Series B Warrants from $5.25 to $4.00, provided that the Holder exercised its Warrant for cash at the time of entry into such Letter Agreement. Each Holder exercised its Series B Warrants in full and the Company issued an aggregate of 1,224,263 shares of Common Stock to them. The Company received net proceeds of approximately $4,900,000. As a result of the modification of the exercise price of these warrants, the Company recognized an incremental value of $369,500, which was recorded as a deemed dividend on the condensed consolidated statement of operations and comprehensive loss for the three and nine months ended September 30, 2019, using the Black-Scholes pricing model with the following assumptions: Expected term 2.88 years Volatility 111.5% Dividend yield 0.0% Risk-free interest rate 1.62% During the year ended September 30, 2019, the expiration date of a warrant to purchase up to 100,000 shares of the Company's common stock was extended from May 30, 2019 to August 16, 2019, then subsequently included in the Exchange Agreement transaction (see Note 4). The warrant had an exercise price of $0.005. The incremental value of the warrant extended was immaterial. During the nine months ended September 30, 2019, the Company issued an aggregate of 1,944,707 shares of its common stock upon exercise of warrants, resulting in net proceeds of $8,658,000. As of September 30, 2019, there were 344,828 outstanding warrants with a weighted average exercise price of $6.22 per share and a weighted average remaining contractual life of 1.7 years. |
Related Party
Related Party | 9 Months Ended |
Sep. 30, 2019 | |
Related Party Transactions [Abstract] | |
Related Party | Note 4 — Related Party: In May 2013, the Company issued a warrant to purchase up to 100,000 shares of the Company's common stock to 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 the Exchange Agreement, the Company extended the expiration date of the warrant to July 1, 2019, which was subsequently extended to August 16, 2019. The warrant had an exercise price of $0.005. The incremental value of the warrant extended was immaterial. On August 14, 2019, the Company entered into the Exchange Agreement with Elliott, who collectively beneficially own the largest portion of the Company's common stock, pursuant to which Elliott agreed to exchange all of its outstanding warrants, its 10% senior secured convertible note and its 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 to the Company, for 100,000 shares of Series G Preferred Stock (see Note 3). |
Senior Secured Convertible Note
Senior Secured Convertible Note, Related Party | 9 Months Ended |
Sep. 30, 2019 | |
Debt Disclosure [Abstract] | |
Senior Secured Convertible Note, Related Party | Note 5 — Senior Secured Convertible Note, Related Party: On December 31, 2018, the Company entered into a securities purchase agreement with Elliott 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 the Company's common stock, for gross proceeds of $7.5 million. The senior secured convertible note and warrant to purchase up to an aggregate of 90,000 shares of the Company's common stock were cancelled in connection with the terms of the Exchange Agreement. The note was a senior obligation, secured by all of the Company's assets. The note bore interest at a 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, until its cancellation. The note was to mature on December 30, 2021. Any accrued but unpaid interest for the applicable interest period was added to the principal outstanding under the notes. The note had a conversion price of $7.50 per share. The conversion price was subject to appropriate adjustment in the event of stock dividends and distributions, stock splits, stock combinations, or reclassifications affecting the Company's common stock. The noteholder was able to 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 would 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 held 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 was able to 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 would have equaled 105% of the principal amount being repaid. For three and nine months ended September 30, 2019, approximately $82,000 and $462,000, respectively, was accrued and recognized as interest expense on the condensed consolidated statement of operations and comprehensive loss. The senior secured convertible note, including accrued interest, was exchanged as a result of the Exchange Agreement. The warrant was immediately exercisable, had 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 had 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 the Company's 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"). These warrants were subsequently cancelled in connection with the Exchange Agreement. Also in conjunction with the December 2018 securities purchase agreement, 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, however, with the exception of the Series E preferred stock, the Elliot Derivative Securities were cancelled in connection with the Exchange Agreement. The Company was required to have a majority of the Series C-2, Series D, Series E and Series F non-voting preferred stock consent to 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. At the time of the securities purchase agreement, Elliott was the holder of all of the shares of the Series C-2, Series D, Series E and Series F non-voting preferred stock and implicitly consented to the convertible note financing. Elliott is currently the holder of all of the shares of the Series E and Series G preferred stock. 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 was 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 nine months ended September 30, 2019, approximately $84,000 and $313,000, respectively, was recognized as amortization of debt discount and is included in interest expense on the condensed consolidated statement of operations and comprehensive loss. 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," As part of the Exchange Agreement, the senior secured convertible note, along with certain warrants and the Series C-2, Series D and Series F Preferred Stock, and the payment of $2,000,000, was exchanged for 100,000 shares of Series G Preferred Stock. As a result of this transaction, the Company recognized a deemed dividend of $26,733,098 on its condensed consolidated statement of operations and comprehensive loss for the three and nine months ended September 30, 2019 (see Note 3). |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 6 — 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-HEP100 TM TM The Court issued its decisions on May 8, 2015, staying both proceedings. In its decisions, the Court found that the commercialization by TauroPharm in Germany of its TauroLock catheter lock solutions Hep100 and Hep500 infringes both the Prosl European Patent and the Utility Model and further that there is no prior use right that would allow TauroPharm to continue to make, use or sell its product in Germany. However, the Court declined to issue an injunction in favor of the Company that would preclude the continued commercialization by TauroPharm based upon its finding that there is a sufficient likelihood that the EPO, in the case of the Prosl European Patent, or the German PTO, in the case of the Utility Model, may find that such patent or utility model is invalid. Specifically, the Court noted the possible publication of certain instructions for product use that may be deemed to constitute prior art. As such, the District Court determined that it will defer any consideration of the request by the Company for injunctive and other relief until such time as the EPO or the German PTO 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 was held on September 17, 2019 in which the German Federal Patent affirmed the first instance decision that the Utility Model was invalid. 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. 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 TauroLock TM In connection with the aforementioned patent and utility model infringement and unfair competition proceedings against TauroPharm, the Company was required by the District Courts of Mannheim and Cologne to provide security deposits of an aggregate of approximately $170,000, to cover legal fees in the event TauroPharm is entitled to reimbursement of these costs. The Company recorded the deposits 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 $1.4 million was incurred through September 30, 2019. Through September 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 $27.4 million has been paid. During the three and nine months ended September 30, 2019, the Company recognized $61,000 and $763,000, respectively, in research and development expense related to the Master Service Agreement and $5,783,000 and $14,822,000 during the three and nine months ended September 30, 2018. At September 30, 2019, the Company had accrued approximately $1,704,000 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 September 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 September 30, 2019 and 2018. Events that trigger milestone payments include but are not limited to the reaching of various stages of regulatory approval and achieving certain worldwide net sales amounts. There were no milestones achieved during the nine months ended September 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 Phoebe Mounts 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. Khoso Baluch On September 26, 2019, the Company entered into a new employment agreement with Khoso Baluch, the Company's Chief Executive Officer. Unless renewed pursuant to the terms thereof, the agreement will expire on September 25, 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. Upon entry into the agreement, the Company granted to Mr. Baluch a stock option to purchase 120,000 shares of our common stock, which vests in four equal annual installments over four years on the first four anniversaries of the effective date of the agreement, provided, in all cases, that Mr. Baluch remains an employee or consultant through the applicable vesting date. If the Company terminates Mr. Baluch's employment other than for Cause (as defined in the agreement), death, disability, or by notice of nonrenewal, or if he resigns for Good Reason (as defined in the agreement), including in each case within 24 months of a Change of Control (as defined in the agreement), Mr. Baluch will receive his base salary and benefits for a period of 12 months following the effective date of the termination of his employment, and all unvested stock options held by him that are scheduled to vest on or before the next succeeding anniversary of the date of termination 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. |
Leases
Leases | 9 Months Ended |
Sep. 30, 2019 | |
Leases [Abstract] | |
Leases | Note 7 — 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 $6,000 was recognized in the Company's condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2018. Operating lease expense in the Company's condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2019 was approximately $2,000 and $6,000, which includes costs associated with leases for which ROU assets have been recognized as well as short-term leases. At September 30, 2019, the Company has a total operating lease liability of $5,000. Approximately $2,000 and $3,000, 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 September 30, 2019 are $5,000 and are included in property and equipment, net on the condensed consolidated balance sheet. For the three and nine months ended September 30, 2019, cash paid for amounts included in the measurement of lease liabilities in operating cash flows from operating leases was $2,000 and $6,000, respectively. The weighted average remaining lease term and weighted average discount rate for operating leases were 2.8 years and 10.0%, respectively, as of September 30, 2019. As of September 30, 2019, maturities of lease liabilities were as follows: 2019 (excluding the nine months ended September 30, 2019) $ 1,000 2020 2,000 2021 2,000 2022 1,000 Total future minimum lease payments 6,000 Less imputed interest (1,000 ) Total $ 5,000 |
Concentrations
Concentrations | 9 Months Ended |
Sep. 30, 2019 | |
Concentrations [Abstract] | |
Concentrations | Note 8 — Concentrations: At September 30, 2019, 99% of net accounts receivable was due from two customers that exceeded 10% of the Company's accounts receivable (74% and 25%) and at 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 September 30, 2019, the Company had revenue from a customer that exceeded 10% of its total sales of $60,000 (77%) and for the nine months ended September 30, 2019, the Company had revenue from four customers that each exceeded 10% of its total sales of $258,000 (46%, 20%, 13% and 13%). During the three months and nine months ended September 30, 2018, the Company had revenue from two customers that each exceeded 10% of its total sales (81% and 14%) and (75% and 16%), respectively. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
Liquidity and Uncertainties | 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 September 30, 2019, the Company had an accumulated deficit of $190.1 million, and incurred losses from operations of $5.3 million and $10.2 million for the three months ended September 30, 2019 and 2018, respectively, and $11.1 million and $29.0 million for the nine months ended September 30, 2019 and 2018, respectively. The Company currently estimates that as of September 30, 2019 it has sufficient cash, cash equivalents and short-term investments on hand to fund operations into the first quarter of 2021, 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 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. On September 6, 2019, the Company received gross proceeds of approximately $2.0 million as a result of the Exchange Agreement with Elliott (see Note 3). On September 25, 2019, the Company received net proceeds of approximately $4.9 million as a result of agreements it entered into with several holders (each a "Holder") of several Series B Warrants ("Series B Warrants") that the Company had issued on May 3, 2017, and amended on September 20, 2019 (each, a "Letter Agreement"). Pursuant to each Letter Agreement, the Company agreed to reduce the exercise price of each Holder's Series B Warrants from $5.25 to $4.00, provided that the Holder exercised its Series B Warrants for cash at the time of entry into such Letter Agreement. Each Holder exercised its Series B Warrants in full and the Company issued an aggregate of 1,224,263 shares of Common Stock to them. As a result of the modification of the exercise price of these warrants, the Company recognized an incremental value of $369,500, which was recorded as a deemed dividend on the condensed consolidated statement of operations and comprehensive loss (see Note 3). 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 statement 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 | 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 | 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 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 September 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 September 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 September 30, 2019 and December 31, 2018: Amortized Cost Gross Unrealized Losses Gross Unrealized Gains Fair Value September 30, 2019: Money Market Funds and Cash Equivalents $ 3,093,197 $ (78 ) $ - $ 3,093,119 U.S. Government Agency Securities 2,987,985 - 785 2,988,770 Corporate Securities 6,559,563 (301 ) 3,841 6,563,103 Commercial Paper 2,741,950 (76 ) 543 2,742,417 Subtotal 12,289,498 (377 ) 5,169 12,294,290 Total September 30, 2019 $ 15,382,695 $ (455 ) $ 5,169 $ 15,387,409 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 | Fair Value Measurements The Company's financial instruments recorded in the condensed consolidated balance sheets include cash and cash equivalents, accounts receivable, investment securities, accounts payable and accrued expenses. The carrying value of certain financial instruments, primarily cash and cash equivalents, accounts receivable, accounts payable, and accrued expenses approximate their estimated fair values based upon the short-term nature of their maturity dates. The Company categorizes its financial instruments into a three-level fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets (Level 1) and the lowest priority to unobservable inputs (Level 3). If the inputs used to measure fair value fall within different levels of the hierarchy, the category level is based on the lowest priority level input that is significant to the fair value measurement of the instrument. Financial assets recorded at fair value on the Company's condensed consolidated balance sheets are categorized as follows: ● Level 1 inputs—Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets. ● Level 2 inputs— Significant other observable inputs (e.g., quoted prices for similar items in active markets, quoted prices for identical or similar items in markets that are not active, inputs other than quoted prices that are observable such as interest rate and yield curves, and market-corroborated inputs). ● Level 3 inputs—Unobservable inputs for the asset or liability, which are supported by little or no market activity and are valued based on management's estimates of assumptions that market participants would use in pricing the asset or liability. The following table provides the carrying value and fair value of the Company's financial assets measured at fair value on a recurring basis as of September 30, 2019 and December 31, 2018: Carrying Value Level 1 Level 2 Level 3 September 30, 2019: Money Market Funds and Cash Equivalents $ 3,093,119 $ 2,044,578 $ 1,048,541 $ - U.S. Government Agency Securities 2,988,770 2,988,770 - - Corporate Securities 6,563,103 - 6,563,103 - Commercial Paper 2,742,417 - 2,742,417 - Subtotal 12,294,290 2,988,770 9,305,520 $ - Total September 30, 2019 $ 15,387,409 $ 5,033,348 $ 10,354,061 $ - 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 | 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 | Restricted Cash As of September 30, 2019 and December 31, 2018, the Company has restricted cash in connection with the patent and utility model infringement and unfair competition proceedings against TauroPharm (see Note 6). The Company was required by the District Courts of Mannheim and Cologne to provide security deposits of an aggregate of approximately $170,000 to cover legal fees in the event TauroPharm is entitled to reimbursement of these costs. |
Prepaid Research and Development | 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, net Inventories are valued at the lower of cost or net realizable value on a first in, first out basis. Inventories consist of raw materials (including labeling and packaging), work-in-process, and finished goods, if any, for the Neutrolin product. Inventories consist of the following: September 30, December 31, Raw materials $ 6,893 $ 71,275 Work in process - 86,957 Finished goods 477,172 373,283 Inventory reserve (103,000 ) (103,000 ) Total $ 381,065 $ 428,515 |
Leases | 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 condensed 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 Accrued expenses consist of the following: September 30, December 31, Professional and consulting fees $ 360,814 $ 258,352 Accrued payroll and payroll taxes 1,055,454 1,102,143 Clinical trial related 1,703,825 3,408,032 Manufacturing development related 653,143 210,577 Product development - 49,200 Other 173,982 137,920 Total $ 3,947,218 $ 5,166,224 |
Revenue Recognition | 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 | 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 September 30, 2019 and 2018 and $6,600 for the nine months ended September 30, 2019 and 2018, respectively. Deferred revenue related to the Wonik Agreement at September 30, 2019 and December 31, 2018 amounted to approximately $4,400 and $11,000, respectively. |
Loss Per Common Share | Loss Per Common Share Basic loss per common share excludes any potential dilution and is computed by dividing net loss by the weighted average number of common shares outstanding during the period. Diluted net loss per common share reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that then shared in the earnings of the entity. However, since their effect is anti-dilutive, the Company has excluded potentially dilutive shares. The following potentially dilutive shares have been excluded from the calculation of diluted net loss per share as their effect would be anti-dilutive. Nine Months Ended 2019 2018 (Number of Shares of Series C-3 non-voting preferred stock 108,000 508,000 Series D non-voting preferred stock - 295,848 Series E non-voting preferred stock 391,953 391,952 Series F non-voting preferred stock - 2,469,136 Series G non-voting preferred stock 5,560,137 - Restricted stock units 8,411 19,506 Shares issuable for payment of deferred board compensation 31,498 - Shares underlying outstanding warrants 344,828 1,097,102 Shares underlying outstanding stock options 1,435,110 3,717,478 Total potentially dilutive shares 7,879,937 8,499,022 |
Stock-Based Compensation | Stock-Based Compensation Share-based compensation cost for stock options granted to employees is measured at grant date, based on the estimated fair value of the award using the Black-Scholes option pricing model for options with service or performance-based conditions and is recognized as expense over the employee's requisite service period on a straight-line basis. The Company accounts for stock options granted to non-employees on a fair value basis using the Black-Scholes option pricing model in accordance with ASC No. 718, "Compensation-Stock Compensation" "Equity-Based Payments to Non-Employees" |
Research and Development | 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. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
Marketable securities | Amortized Cost Gross Unrealized Losses Gross Unrealized Gains Fair Value September 30, 2019: Money Market Funds and Cash Equivalents $ 3,093,197 $ (78 ) $ - $ 3,093,119 U.S. Government Agency Securities 2,987,985 - 785 2,988,770 Corporate Securities 6,559,563 (301 ) 3,841 6,563,103 Commercial Paper 2,741,950 (76 ) 543 2,742,417 Subtotal 12,289,498 (377 ) 5,169 12,294,290 Total September 30, 2019 $ 15,382,695 $ (455 ) $ 5,169 $ 15,387,409 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 | Carrying Value Level 1 Level 2 Level 3 September 30, 2019: Money Market Funds and Cash Equivalents $ 3,093,119 $ 2,044,578 $ 1,048,541 $ - U.S. Government Agency Securities 2,988,770 2,988,770 - - Corporate Securities 6,563,103 - 6,563,103 - Commercial Paper 2,742,417 - 2,742,417 - Subtotal 12,294,290 2,988,770 9,305,520 $ - Total September 30, 2019 $ 15,387,409 $ 5,033,348 $ 10,354,061 $ - 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 | September 30, December 31, Raw materials $ 6,893 $ 71,275 Work in process - 86,957 Finished goods 477,172 373,283 Inventory reserve (103,000 ) (103,000 ) Total $ 381,065 $ 428,515 |
Schedule of accrued expenses | September 30, December 31, Professional and consulting fees $ 360,814 $ 258,352 Accrued payroll and payroll taxes 1,055,454 1,102,143 Clinical trial related 1,703,825 3,408,032 Manufacturing development related 653,143 210,577 Product development - 49,200 Other 173,982 137,920 Total $ 3,947,218 $ 5,166,224 |
Schedule of anti-dilutive securities excluded from calculation of diluted net loss per share | Nine Months Ended 2019 2018 (Number of Shares of Series C-3 non-voting preferred stock 108,000 508,000 Series D non-voting preferred stock - 295,848 Series E non-voting preferred stock 391,953 391,952 Series F non-voting preferred stock - 2,469,136 Series G non-voting preferred stock 5,560,137 - Restricted stock units 8,411 19,506 Shares issuable for payment of deferred board compensation 31,498 - Shares underlying outstanding warrants 344,828 1,097,102 Shares underlying outstanding stock options 1,435,110 3,717,478 Total potentially dilutive shares 7,879,937 8,499,022 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Preferred stock | As of September 30, 2019 As of December 31, 2018 Preferred Shares Outstanding Liquidation Preference Total Liquidation Preference Preferred Shares Outstanding Liquidation Preference Total Liquidation Preference Series C-2 - - - 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 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 Series G 100,000 $ 187.36 $ 18,736,452 - - - Total 243,623 $ 23,685,904 419,585 $ 10,502,654 |
Fair value assumptions for Black Sholes | Expected term, years 3.0 Volatility 93.3 % Dividend yield 0.0 % Risk-free interest rate 1.53 % |
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 $ 983,353 Granted 493,300 $ 7.65 $ 82,824 Forfeited (32,690 ) $ 6.45 $ 41,137 Expired (177 ) $ 3.66 $ 530 Exercised (36,590 ) $ 3.21 $ 115,913 Outstanding at end of period 1,435,110 $ 8.97 7.1 $ 908,597 Exercisable at end of period 788,031 $ 9.16 5.8 $ 719,160 |
Warrants [Member] | |
Fair value assumptions for Black Sholes | Expected term 2.88 years Volatility 111.5% Dividend yield 0.0% Risk-free interest rate 1.62% |
Stock Options [Member] | |
Fair value assumptions for Black Sholes | Expected term, years 4.17 - 10 Volatility 102.8% - 104.22% Dividend yield 0.0% Risk-free interest rate 1.52% - 2.74% Weighted average grant date fair value of options granted during the period $6.71 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Leases [Abstract] | |
Maturities of lease liabilities | 2019 (excluding the nine months ended September 30, 2019) $ 1,000 2020 2,000 2021 2,000 2022 1,000 Total future minimum lease payments 6,000 Less imputed interest (1,000 ) Total $ 5,000 |
Organization, Business and Ba_2
Organization, Business and Basis of Presentation (Details) - USD ($) | 1 Months Ended | |||
Aug. 14, 2019 | Sep. 30, 2019 | Mar. 26, 2019 | Dec. 31, 2018 | |
Organization, Business and Basis of Presentation (Textual) | ||||
Business combination, description | The Company's primary focus is to develop its lead product candidate, Neutrolin®, for potential commercialization in the United States ("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 | |||
Right of use asset | $ 5,000 | |||
Lease liability | $ 3,000 | |||
Exchange agreement, description | On August 14, 2019, the Company entered into an exchange agreement (the "Exchange Agreement") with Manchester Securities Corp. ("Manchester"), a wholly owned subsidiary of Elliott Associates, L.P. (together with Manchester, "Elliott"), who collectively beneficially own the largest portion of the Company's Common Stock pursuant to which Elliott agreed to exchange all of its outstanding warrants, its 10% senior secured convertible note and its 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 to the Company, for 100,000 shares of Series G Preferred Stock (see Note 3). This transaction closed on September 6, 2019. | |||
Common stock, par value | $ 0.001 | $ 0.001 | $ 0.001 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) - USD ($) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Amortized cost | $ 15,382,695 | $ 1,179,673 |
Gross unrealized losses | (455) | 0 |
Gross unrealized gains | 5,169 | 0 |
Commercial Paper [Member] | ||
Amortized cost | 2,741,950 | 0 |
Gross unrealized losses | (76) | 0 |
Gross unrealized gains | 543 | 0 |
Corporate Securities [Member] | ||
Amortized cost | 6,559,563 | 0 |
Gross unrealized losses | (301) | 0 |
Gross unrealized gains | 3,841 | 0 |
Money Market Funds and Cash Equivalents [Member] | ||
Amortized cost | 3,093,197 | 1,179,673 |
Gross unrealized losses | (78) | 0 |
Gross unrealized gains | 0 | 0 |
Subtotal [Member] | ||
Amortized cost | 12,289,498 | 0 |
Gross unrealized losses | (377) | 0 |
Gross unrealized gains | 5,169 | 0 |
U.S. Government Agency Securities [Member] | ||
Amortized cost | 2,987,985 | 0 |
Gross unrealized losses | 0 | 0 |
Gross unrealized gains | $ 785 | $ 0 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies (Details 1) - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 |
Carrying Value | $ 15,387,409 | $ 1,179,673 |
Money Market Funds included in Cash Equivalents | ||
Carrying Value | 3,093,119 | 1,179,673 |
U.S. Government Agency Securities | ||
Carrying Value | 2,988,770 | 0 |
Corporate Securities | ||
Carrying Value | 6,563,103 | 0 |
Commercial Paper | ||
Carrying Value | 2,742,417 | 0 |
Subtotal | ||
Carrying Value | 12,294,290 | 0 |
Level 3 | ||
Carrying Value | 0 | 0 |
Level 3 | Money Market Funds included in Cash Equivalents | ||
Carrying Value | 0 | 0 |
Level 3 | U.S. Government Agency Securities | ||
Carrying Value | 0 | 0 |
Level 3 | Corporate Securities | ||
Carrying Value | 0 | 0 |
Level 3 | Commercial Paper | ||
Carrying Value | 0 | 0 |
Level 3 | Subtotal | ||
Carrying Value | 0 | 0 |
Level 2 | ||
Carrying Value | 10,354,061 | 0 |
Level 2 | Money Market Funds included in Cash Equivalents | ||
Carrying Value | 1,048,541 | 0 |
Level 2 | U.S. Government Agency Securities | ||
Carrying Value | 0 | 0 |
Level 2 | Corporate Securities | ||
Carrying Value | 6,563,103 | 0 |
Level 2 | Commercial Paper | ||
Carrying Value | 2,742,417 | 0 |
Level 2 | Subtotal | ||
Carrying Value | 9,305,520 | 0 |
Level 1 | ||
Carrying Value | 5,033,348 | 1,179,673 |
Level 1 | Money Market Funds included in Cash Equivalents | ||
Carrying Value | 2,044,578 | 1,179,673 |
Level 1 | U.S. Government Agency Securities | ||
Carrying Value | 2,988,770 | 0 |
Level 1 | Corporate Securities | ||
Carrying Value | 0 | 0 |
Level 1 | Commercial Paper | ||
Carrying Value | 0 | 0 |
Level 1 | Subtotal | ||
Carrying Value | $ 2,988,770 | $ 0 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies (Details 2) - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 |
Accounting Policies [Abstract] | ||
Raw materials | $ 6,893 | $ 71,275 |
Work in process | 86,957 | |
Finished goods | 477,172 | 373,283 |
Inventory reserve | (103,000) | (103,000) |
Total | $ 381,065 | $ 428,515 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies (Details 3) - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 |
Accounting Policies [Abstract] | ||
Professional and consulting fees | $ 360,814 | $ 258,352 |
Accrued payroll and payroll taxes | 1,055,454 | 1,102,143 |
Clinical trial related | 1,703,825 | 3,408,032 |
Manufacturing development related | 653,143 | 210,577 |
Product development | 49,200 | |
Other | 173,982 | 137,920 |
Total | $ 3,947,218 | $ 5,166,224 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies (Details 4) - shares | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Antidilutive Shares | 7,879,937 | 8,499,022 |
Series G non-voting preferred stock [Member] | ||
Antidilutive Shares | 5,560,137 | 0 |
Shares issuable for payment of deferred board compensation | ||
Antidilutive Shares | 31,498 | |
Shares underlying restricted stock units | ||
Antidilutive Shares | 8,411 | 19,506 |
Shares underlying outstanding warrants | ||
Antidilutive Shares | 344,828 | 1,097,102 |
Shares underlying outstanding stock options | ||
Antidilutive Shares | 1,435,110 | 3,717,478 |
Series D non-voting convertible preferred stock | ||
Antidilutive Shares | 295,848 | |
Series C non-voting convertible preferred stock | ||
Antidilutive Shares | 108,000 | 508,000 |
Series E non-voting convertible preferred stock | ||
Antidilutive Shares | 391,953 | 391,952 |
Series F non-voting convertible preferred stock | ||
Antidilutive Shares | 2,469,136 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies (Details Textual) - USD ($) | Sep. 06, 2019 | Sep. 25, 2019 | Apr. 30, 2019 | Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 |
Summary of Significant Accounting Policies (Textual) | ||||||||
Accumulated deficit | $ (190,116,987) | $ (190,116,987) | $ (178,988,098) | |||||
Deferred revenue | 4,400 | 4,400 | $ 11,000 | |||||
Deferred revenue recognized | 2,200 | $ 2,200 | $ 6,600 | $ 6,600 | ||||
Net operating loss, description | 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 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. | 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 statement for the issuance of equity, debt or equity-linked securities unrelated to the current ATM program. | ||||||
Restricted cash, description | The Company was required by the District Courts of Mannheim and Cologne to provide security deposits of an aggregate of approximately $170,000 to cover legal fees in the event TauroPharm is entitled to reimbursement of these costs. | |||||||
Deferred revenue, description | 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"). | |||||||
Gross proceeds | $ 2,000,000 | |||||||
Letter agreements, description | The Company received net proceeds of approximately $4.9 million as a result of agreements it entered into with several holders (each a "Holder") of several Series B Warrants ("Series B Warrants") that the Company had issued on May 3, 2017, and amended on September 20, 2019 (each, a "Letter Agreement"). Pursuant to each Letter Agreement, the Company agreed to reduce the exercise price of each Holder's Series B Warrants from $5.25 to $4.00, provided that the Holder exercised its Series B Warrants for cash at the time of entry into such Letter Agreement. Each Holder exercised its Series B Warrants in full and the Company issued an aggregate of 1,224,263 shares of Common Stock to them. As a result of the modification of the exercise price of these warrants, the Company recognized an incremental value of $369,500, which was recorded as a deemed dividend on the condensed consolidated statement of operations and comprehensive loss (see Note 3). | |||||||
Loss from operation | $ (5,264,847) | $ (10,236,119) | $ (11,128,889) | $ (28,978,147) |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 |
Preferred shares outstanding | 243,623 | 419,585 |
Total Liquidation Preference | $ 23,685,904 | $ 10,502,654 |
Series F [Member] | ||
Preferred shares outstanding | 2,000 | |
Liquidation Preference (Per Share) | $ 1,000 | |
Total Liquidation Preference | $ 2,000,000 | |
Series C-2 [Member] | ||
Preferred shares outstanding | 150,000 | |
Liquidation Preference (Per Share) | $ 10 | |
Total Liquidation Preference | $ 1,500,000 | |
Series E [Member] | ||
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 C-3 [Member] | ||
Preferred shares outstanding | 54,000 | 104,000 |
Liquidation Preference (Per Share) | $ 10 | $ 10 |
Total Liquidation Preference | $ 540,000 | $ 1,040,000 |
Series D [Member] | ||
Preferred shares outstanding | 73,962 | |
Liquidation Preference (Per Share) | $ 21 | |
Total Liquidation Preference | $ 1,553,202 | |
Series G [Member] | ||
Preferred shares outstanding | 100,000 | |
Liquidation Preference (Per Share) | $ 187.36 | |
Total Liquidation Preference | $ 18,736,452 |
Stockholders' Equity (Details 1
Stockholders' Equity (Details 1) | 9 Months Ended |
Sep. 30, 2019 | |
Stockholders Equity [Abstract] | |
Expected term, years | 3 years |
Volatility | 93.30% |
Dividend yield | 0.00% |
Risk-free interest rate | 1.53% |
Stockholders' Equity (Details 2
Stockholders' Equity (Details 2) | 9 Months Ended |
Sep. 30, 2019$ / shares | |
Dividend yield | 0.00% |
Weighted-average fair value of options granted during the period | $ 6.71 |
Minimum [Member] | |
Expected term | 4 years 2 months 1 day |
Volatility | 102.80% |
Risk-free interest rate | 1.52% |
Minimum [Member] | |
Expected term | 10 years |
Volatility | 104.22% |
Risk-free interest rate | 2.74% |
Stockholders' Equity (Details 3
Stockholders' Equity (Details 3) | 9 Months Ended |
Sep. 30, 2019USD ($)$ / sharesshares | |
Stockholders Equity [Abstract] | |
Number of Options Outstanding, Beginning | shares | 1,011,267 |
Number of Options Granted | shares | 493,300 |
Number of Options Forfeited | shares | (32,690) |
Number of Options Expired | shares | (177) |
Number of Options Exercised | shares | (36,590) |
Number of Options Outstanding, Ending | shares | 1,435,110 |
Number of Options Exercisable | shares | 788,031 |
Weighted Average Exercise Price Outstanding, Beginning | $ 9.32 |
Weighted Average Exercise Price Granted | 7.65 |
Weighted Average Exercise Price Forfeited | 6.45 |
Weighted Average Exercise Price Expired | 3.66 |
Weighted Average Exercise Price Exercised | 3.21 |
Weighted Average Exercise Price Outstanding, Ending | 8.97 |
Weighted Average Exercise Price Exercisable | $ 9.16 |
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 | 5 years 9 months 18 days |
Aggregate Intrinsic Value Outstanding, Beginning | $ | $ 983,353 |
Aggregate Intrinsic Value, Granted | $ 82,824 |
Aggregate Intrinsic Value, Forfeited | 41,137 |
Aggregate Intrinsic Value, Expired | $ 530 |
Aggregate Intrinsic Value, Exercised | $ | $ 115,913 |
Aggregate Intrinsic Value Outstanding, Ending | $ | 908,597 |
Aggregate Intrinsic Value, Exercisable | $ | $ 719,160 |
Stockholders' Equity (Details 4
Stockholders' Equity (Details 4) | 9 Months Ended |
Sep. 30, 2019 | |
Stockholders Equity [Abstract] | |
Expected term | 2 years 10 months 17 days |
Volatility | 111.50% |
Dividend yield | 0.00% |
Risk-free interest rate | 1.62% |
Stockholders' Equity (Details T
Stockholders' Equity (Details Textual) - USD ($) | Nov. 09, 2017 | Aug. 14, 2019 | Mar. 09, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 |
Stockholders' Equity (Textual) | ||||||||
Stock-based compensation for stock options issued | $ 593,000 | $ 339,000 | $ 1,909,000 | $ 1,026,000 | ||||
Unrecognized compensation expense | $ 2,770,000 | $ 2,770,000 | ||||||
Warrants, weighted average remaining contractual life | 1 year 7 months 24 days | |||||||
Warrants, weighted average exercise price per share | $ 6.22 | $ 6.22 | ||||||
Intrinsic value of stock options exercised | $ 115,913 | |||||||
Sale of common stock | 1,768,012 | |||||||
Total sale value | $ 15,200,000 | $ 15,200,000 | ||||||
New ATM agreement, description | 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 such as the number or dollar amount of shares registered under the registration statement to which the offering relates and subject to B. Riley's acceptance. B. Riley is entitled to a commission of up to 3% of the gross proceeds from the sale of shares of common stock sold under the ATM program. | The Company has approximately $4.6 million available under its current ATM program and $30.3 million available under its current shelf registration statement for the issuance of equity, debt or equity-linked securities unrelated to the current ATM program. | ||||||
Conversion of stock, description | The Company issued an aggregate of 36,590 shares of its common stock upon exercise of stock options, resulting in net proceeds of $118,000. | |||||||
Preferred stock, par value | $ 0.001 | $ 0.001 | $ 0.001 | |||||
Preferred stock, shares authorized | 2,000,000 | 2,000,000 | 2,000,000 | |||||
Securities purchase agreement, description | The Company entered into a securities purchase agreement which, on November 16, 2017, resulted in the Company selling $2.0 million of its Series F preferred stock ("Series F Stock") at $1,000 per share. Based on the terms of the Series F Stock, the conversion price was initially set at $0.162. The conversion price of the Series F Stock was 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 did 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. All outstanding shares of Series F Stock were cancelled in connection with the terms of the Exchange Agreement, as described below. | |||||||
Exchange agreement, description | On August 14, 2019, the Company entered into an exchange agreement (the "Exchange Agreement") with Manchester Securities Corp. ("Manchester"), a wholly owned subsidiary of Elliott Associates, L.P. (together with Manchester, "Elliott"), who collectively beneficially own the largest portion of the Company's Common Stock pursuant to which Elliott agreed to exchange all of its outstanding warrants, its 10% senior secured convertible note and its 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 to the Company, for 100,000 shares of Series G Preferred Stock (see Note 3). This transaction closed on September 6, 2019. | |||||||
Dividend yield | 0.00% | |||||||
Expected term, description | 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. | |||||||
Series C-2 Preferred Stock [Member] | ||||||||
Stockholders' Equity (Textual) | ||||||||
Exchange agreement, description | Pursuant to the terms of the Exchange Agreement, the exchange of the Series C-2 Preferred Stock, Series D Preferred Stock, Series F Preferred Stock and the 10% senior secured convertible note was considered an extinguishment. As a result, the difference between the fair value allocated to the Series G Preferred Stock and the carrying value of the Series C-2 Preferred Stock, Series D Preferred Stock, Series F Preferred Stock and the 10% senior secured convertible note is being treated as a deemed dividend and is added to net loss to arrive at loss available to common stockholders. | |||||||
Senior Secured Convertible Note [Member] | ||||||||
Stockholders' Equity (Textual) | ||||||||
Exchange agreement, description | The Exchange Agreement, the Company recognized a deemed dividend of $26,733,098. The deemed dividend was comprised of (1) a beneficial conversion related to the 10% secured senior convertible note recognized at extinguishment; (2) the difference between the allocated fair value of the Series G Preferred Stock issued and the carrying values of the 10% secured senior convertible note, the Series C-2 Preferred Stock, Series D Preferred Stock and Series F Preferred Stock; (3) the difference between the fair value of the exchanged warrants before and after the Exchange Agreement; and (4) the difference between the fair value and the carrying value of Series E Preferred Stock, less the fair value of the Series E warrants that were cancelled as part of the Exchange Agreement. | |||||||
Expected term, description | The Exchange Agreement, the senior secured convertible note, along with certain warrants and the Series C-2, Series D and Series F Preferred Stock, and the payment of $2,000,000, was exchanged for 100,000 shares of Series G Preferred Stock. As a result of this transaction, the Company recognized a deemed dividend of $26,733,098 on its condensed consolidated statement of operations and comprehensive loss for the three and nine months ended September 30, 2019 (see Note 3). | |||||||
Series C-3 | ||||||||
Stockholders' Equity (Textual) | ||||||||
Conversion of stock, description | The Company issued 100,000 shares of its common stock upon conversion of 50,000 shares of Series C-3 Non-Voting Preferred Stock. | |||||||
Warrants [Member] | ||||||||
Stockholders' Equity (Textual) | ||||||||
Warrants, weighted average remaining contractual life | 1 year 8 months 12 days | |||||||
Warrants, weighted average exercise price per share | $ 6.22 | $ 6.22 | ||||||
Outstanding warrants | 344,828 | |||||||
Conversion of stock, description | The Company issued an aggregate of 1,944,707 shares of its common stock upon exercise of warrants, resulting in net proceeds of $8,658,000. | |||||||
Exchange agreement, description | The expiration date of a warrant to purchase up to 100,000 shares of the Company's common stock was extended from May 30, 2019 to August 16, 2019, then subsequently included in the Exchange Agreement transaction (see Note 4). The warrant had an exercise price of $0.005. The incremental value of the warrant extended was immaterial. | |||||||
Letter Agreement. description | The Company entered into Letter Agreements with Holders of Series B Warrants. Pursuant to each Letter Agreement, the Company agreed to reduce the exercise price of each Holder's Series B Warrant from $5.25 to $4.00, provided that the Holder exercised its Warrant for cash at the time of entry into such Letter Agreement. Each Holder exercised its Series B Warrants in full and the Company issued an aggregate of 1,224,263 shares of Common Stock to them. The Company received net proceeds of approximately $4,900,000. As a result of the modification of the exercise price of these warrants, the Company recognized an incremental value of $369,500. | |||||||
2013 Stock Incentive Plan [Member] | ||||||||
Stockholders' Equity (Textual) | ||||||||
Conversion of stock, description | The Company granted ten-year qualified and non-qualified stock options covering an aggregate of 493,300 shares of the Company's common stock under the 2013 Stock Incentive Plan. The weighted average exercise price of these options is $7.65 per share. | |||||||
Exchange agreement [Member] | ||||||||
Stockholders' Equity (Textual) | ||||||||
Exchange agreement, description | The Company entered into the Exchange Agreement with Elliott, pursuant to which Elliott agreed to exchange all of its outstanding warrants, its 10% senior secured convertible note and its 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 to the Company, for 100,000 shares of Series G Preferred Stock, with an aggregate liquidation preference of $18,736,452, which are convertible into an aggregate of 5,560,138 shares of the Company's common stock at a conversion price of $3.37 per share. Elliott retained the shares of the Company's common stock and Series E Preferred Stock that it held at the time of the consummation of the Exchange Agreement. Other than with respect to conversion price and liquidation preference, the Series G Preferred Stock has substantially the same terms as the Company's outstanding Series E Preferred Stock, including the restrictive covenants contained therein as modified as set forth in the Exchange Agreement. However, Elliott is prohibited from converting the Series G Preferred Stock into shares of the Company's common stock to the extent that, as a result of such conversion, Elliott would own more than 4.99% of the total number of shares of the Company's common stock then issued and outstanding. The shares of Series G Preferred Stock are entitled to vote on an as-converted basis with respect to the number of shares of common stock into which they are convertible, based upon an assumed conversion price, solely for the purpose of the voting rights, equal to $7.93, the closing price of the Company's common stock on August 14, 2019, and the Series E Preferred Stock was modified to provide for similar rights to vote on an as-converted basis. The Company filed the Certificate of Designation of the Series G Preferred Stock and the Second Amended and Restated Certificate of Designation of the Series E Preferred Stock with the Secretary of State of the State of Delaware on September 5, 2019. On September 6, 2019, the Company closed this transaction and issued the Series G Preferred Stock. | |||||||
Restricted Stock Unit | ||||||||
Stockholders' Equity (Textual) | ||||||||
Stock issued for restricted stock units vested | 19,425 | |||||||
Compensation expense | $ 52,000 | $ 21,000 | $ 151,000 | $ 65,000 | ||||
Unrecognized compensation expense | $ 57,000 | $ 57,000 | ||||||
Restricted stock units issued | 24,850 | |||||||
Weighted average grant date fair value | $ 8.33 |
Related Party (Details)
Related Party (Details) - $ / shares | Aug. 14, 2019 | May 31, 2013 |
Related Party (Textual) | ||
Related party, description | On August 14, 2019, the Company entered into the Exchange Agreement with Elliott, who collectively beneficially own the largest portion of the Company's common stock, pursuant to which Elliott agreed to exchange all of its outstanding warrants, its 10% senior secured convertible note and its 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 to the Company, for 100,000 shares of Series G Preferred Stock (see Note 3). | |
Warrant issued | 100,000 | |
Exercise price | $ 0.005 |
Senior Secured Convertible No_2
Senior Secured Convertible Note, Related Party (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
May 31, 2013 | Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Senior Secured Convertible Note, Related Party to be Updated - Exchange Agreement (Textual) | |||||
Warrants issued, description | 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 the Company's 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"). | ||||
Debt discount | $ 84,000 | $ 313,097 | |||
Conversion price, description | The note bore interest at a 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, until its cancellation. The note was to mature on December 30, 2021. Any accrued but unpaid interest for the applicable interest period was added to the principal outstanding under the notes. The note had a conversion price of $7.50 per share. The conversion price was subject to appropriate adjustment in the event of stock dividends and distributions, stock splits, stock combinations, or reclassifications affecting the Company's common stock. The noteholder was able to 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 would 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 held 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 was able to 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 would have equaled 105% of the principal amount being repaid. For three and nine months ended September 30, 2019, approximately $82,000 and $462,000, respectively, was accrued and recognized as interest expense on the condensed consolidated statement of operations and comprehensive loss. | ||||
Aggregate principal | 7,500,000 | $ 7,500,000 | |||
Warrant purchase | 90,000 | ||||
Exercise price | $ 0.005 | ||||
Warrant term | 5 years | ||||
Legal fees | $ 109,000 | ||||
Warrants of approximately | 396,000 | ||||
Additional paid-in capital | 6,000 | 6,000 | |||
Net allocated fees | 103,000 | ||||
Incremental cost of approximately | 710,000 | ||||
Letters of credit incurred | 3,000,000 | $ 3,000,000 | |||
Expected term, description | 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. | ||||
Deemed dividend | 26,733,098 | $ 26,733,098 | |||
Senior Secured Convertible Note [Member] | |||||
Senior Secured Convertible Note, Related Party to be Updated - Exchange Agreement (Textual) | |||||
Warrant purchase | 90,000 | ||||
Expected term, description | The Exchange Agreement, the senior secured convertible note, along with certain warrants and the Series C-2, Series D and Series F Preferred Stock, and the payment of $2,000,000, was exchanged for 100,000 shares of Series G Preferred Stock. As a result of this transaction, the Company recognized a deemed dividend of $26,733,098 on its condensed consolidated statement of operations and comprehensive loss for the three and nine months ended September 30, 2019 (see Note 3). | ||||
Warrant [Member] | |||||
Senior Secured Convertible Note, Related Party to be Updated - Exchange Agreement (Textual) | |||||
Debt discount | $ 143,000 | ||||
Aggregate principal | $ 7,500,000 | 7,500,000 | |||
Legal fees | 7,500,000 | ||||
Net allocated fees | $ 7,000,000 | ||||
Common stock [Member] | |||||
Senior Secured Convertible Note, Related Party to be Updated - Exchange Agreement (Textual) | |||||
Warrants issued, description | The warrant was immediately exercisable, had an exercise price of $7.50 per share, subject to adjustment in the event of stock dividends and distributions, stock splits, stock combinations, or reclassifications affecting our common stock, and had a term of five years. |
Commitments and Contingencies (
Commitments and Contingencies (Details) - USD ($) | Mar. 19, 2019 | Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 |
Commitments and Contingencies (Textual) | |||||
New work order approximately | $ 1,400,000 | ||||
accrued expenses | $ 2,000 | 3,000 | |||
Research and development expense - clinical and regulatory | 61,000 | $ 5,783,000 | $ 763,000 | $ 14,822,000 | |
Commitments and Contingencies, description | 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. | ||||
Release shares | 7,277 | ||||
Number of shares | 21,832 | 21,832 | |||
Cash payments | $ 3,000,000 | $ 2,500,000 | |||
Employment Agreements, description | 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. | ||||
New work order approximately | 27,400,000 | 27,400,000 | |||
Accured accounts payable | $ 1,704,000 | $ 1,704,000 | |||
Purchase of common stock | 120,000 | 120,000 | |||
Tauro Pharm [Member] | |||||
Commitments and Contingencies (Textual) | |||||
Amount deposit | $ 170,000 | $ 170,000 |
Leases (Details)
Leases (Details) | Sep. 30, 2019USD ($) |
Leases [Abstract] | |
2019 (excluding the nine months ended September 30, 2019) | $ 1,000 |
2020 | 2,000 |
2021 | 2,000 |
2022 | 1,000 |
Total future minimum lease payments | 6,000 |
Less imputed interest | (1,000) |
Total | $ 5,000 |
Leases (Details Textual)
Leases (Details Textual) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Leases - Ac Lordi to Update(Textual) | ||||
Operating lease expense | $ 2,000 | $ 6,000 | ||
Short-term leases | $ 2,000 | $ 6,000 | ||
Operating lease | 5,000 | |||
Accrued expenses | 2,000 | 3,000 | ||
Property and equipment | 5,000 | 5,000 | ||
Measurement lease liabilities | $ 2,000 | $ 6,000 | ||
Weighted average remaining, description | The weighted average remaining lease term and weighted average discount rate for operating leases were 2.8 years and 10.0%, respectively, as of September 30, 2019. |
Concentrations (Details)
Concentrations (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Revenue sales [Member] | ||||
Concentration risk | 77.00% | |||
Revenue sales | $ 60,000 | $ 258,000 | ||
Customer A [Member] | Revenue sales [Member] | ||||
Concentration risk | 81.00% | 46.00% | 75.00% | |
Customer B [Member] | Revenue sales [Member] | ||||
Concentration risk | 14.00% | 20.00% | 16.00% | |
Customer C [Member] | Revenue sales [Member] | ||||
Concentration risk | 13.00% | |||
Customer D [Member] | Revenue sales [Member] | ||||
Concentration risk | 13.00% | |||
Accounts Receivable [Member] | ||||
Concentration risk | 99.00% | |||
Accounts Receivable [Member] | Customer A [Member] | ||||
Concentration risk | 74.00% | |||
Accounts Receivable [Member] | Customer B [Member] | ||||
Concentration risk | 25.00% |