Document And Entity Information
Document And Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Mar. 25, 2021 | Jun. 30, 2020 | |
Document Information Line Items | |||
Entity Registrant Name | CORMEDIX INC. | ||
Trading Symbol | CRMD | ||
Document Type | 10-K | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Common Stock, Shares Outstanding | 38,024,194 | ||
Entity Public Float | $ 208,400,000 | ||
Amendment Flag | false | ||
Entity Central Index Key | 0001410098 | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Well-known Seasoned Issuer | No | ||
Document Period End Date | Dec. 31, 2020 | ||
Document Fiscal Year Focus | 2020 | ||
Document Fiscal Period Focus | FY | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Entity File Number | 001-34673 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 20-5894890 | ||
Entity Address, Address Line One | 300 Connell Drive | ||
Entity Address, Address Line Two | Suite 4200 | ||
Entity Address, City or Town | Berkeley Heights | ||
Entity Address, State or Province | NJ | ||
Entity Address, Postal Zip Code | 07922 | ||
City Area Code | (908) | ||
Local Phone Number | 517-9500 | ||
Title of 12(b) Security | Common Stock, $0.001 Par Value | ||
Security Exchange Name | NASDAQ | ||
Entity Interactive Data Current | Yes |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Current assets | ||
Cash and cash equivalents | $ 41,905,469 | $ 16,350,237 |
Restricted cash | 191,314 | 174,950 |
Short-term investments | 4,444,072 | 11,984,157 |
Trade receivables, net | 3,357 | 35 |
Inventories, net | 143,564 | 338,465 |
Prepaid research and development expenses | 62,210 | 34,831 |
Security deposit | 20,000 | 20,000 |
Other prepaid expenses and current assets | 1,412,183 | 446,415 |
Total current assets | 48,182,169 | 29,349,090 |
Property and equipment, net | 111,499 | 122,130 |
Operating lease right-of-use assets | 1,014,635 | 4,690 |
TOTAL ASSETS | 49,308,303 | 29,475,910 |
Current liabilities | ||
Accounts payable | 1,128,104 | 1,024,280 |
Accrued expenses | 2,924,351 | 4,798,475 |
Operating lease liabilities, short-term | 109,128 | 2,011 |
Deferred revenue | 2,206 | |
Total current liabilities | 4,161,583 | 5,826,972 |
Operating lease liabilities, net of current portion | 923,708 | 2,678 |
TOTAL LIABILITIES | 5,085,291 | 5,829,650 |
COMMITMENTS AND CONTINGENCIES (Note 7) | ||
STOCKHOLDERS’ EQUITY | ||
Preferred stock - $0.001 par value: 2,000,000 shares authorized; 241,623 shares issued and outstanding at December 31, 2020 and 2019 | 242 | 242 |
Common stock - $0.001 par value: 160,000,000 shares authorized at December 31, 2020 and 2019; 33,558,096 and 25,665,350 shares issued and outstanding at December 31, 2020 and 2019, respectively | 33,558 | 25,665 |
Accumulated other comprehensive gain | 102,006 | 97,257 |
Additional paid-in capital | 261,536,061 | 218,944,268 |
Accumulated deficit | (217,448,855) | (195,421,172) |
TOTAL STOCKHOLDERS’ EQUITY | 44,223,012 | 23,646,260 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ 49,308,303 | $ 29,475,910 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Dec. 31, 2020 | Dec. 31, 2019 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in Dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, authorized | 2,000,000 | 2,000,000 |
Preferred stock, issued | 241,623 | 241,623 |
Preferred stock, outstanding | 241,623 | 241,623 |
Common stock, par value (in Dollars per share) | $ 0.001 | $ 0.001 |
Common stock, authorized | 160,000,000 | 160,000,000 |
Common stock, shares issued | 33,558,096 | 25,665,350 |
Common stock, shares outstanding | 33,558,096 | 25,665,350 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Income (Loss) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Revenue: | ||
Net sales | $ 239,231 | $ 283,266 |
Cost of sales | (204,846) | (373,234) |
Gross profit | 34,385 | (89,968) |
Operating Expenses: | ||
Research and development | (13,377,193) | (11,052,903) |
Selling, general and administrative | (13,877,944) | (9,865,005) |
Total operating expenses | (27,255,137) | (20,917,908) |
Loss From Operations | (27,220,752) | (21,007,876) |
Other Income (Expense): | ||
Interest income | 116,065 | 322,668 |
Foreign exchange transaction loss | (59,165) | (21,156) |
Interest expense including amortization of debt discount | (33,226) | (787,488) |
Total other income (expense) | 23,674 | (485,976) |
Net Loss Before Income Taxes | (27,197,078) | (21,493,852) |
Tax benefit | 5,169,395 | 5,060,778 |
Net Loss | (22,027,683) | (16,433,074) |
Other Comprehensive Income (Loss): | ||
Unrealized gain (loss) from investments | (1,271) | 268 |
Foreign currency translation gain | 6,020 | 467 |
Total other comprehensive income | 4,749 | 735 |
Comprehensive Loss | (22,022,934) | (16,432,339) |
Net Loss | (22,027,683) | (16,433,074) |
Deemed dividend as a result of warrant modification | (369,500) | |
Deemed dividend as a result of exchange of convertible note and Series C-2, Series D and Series F preferred stock, related party | (26,733,098) | |
Net Loss Attributable to Common Shareholders | $ (22,027,683) | $ (43,535,672) |
Net Loss Per Common Share – Basic and Diluted (in Dollars per share) | $ (0.77) | $ (1.80) |
Weighted Average Common Shares Outstanding – Basic and Diluted (in Shares) | 28,561,963 | 24,152,088 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders’ Equity - USD ($) | Common Stock | Preferred Stock – Series C-2, C-3, Series D, Series E, Series E and Series G | Accumulated Other Comprehensive Gain (Loss) | Additional Paid-in Capital | Accumulated Deficit | Total |
Balance at Dec. 31, 2018 | $ 21,775 | $ 420 | $ 96,522 | $ 183,803,636 | $ (178,988,098) | $ 4,934,255 |
Balance (in 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 (in Shares) | 1,768,012 | |||||
Stock issue in connection with warrants exercised | $ 1,948 | 8,672,036 | 8,673,984 | |||
Stock issue in connection with warrants exercised (in Shares) | 1,948,207 | |||||
Exchange of convertible note for Series G preferred stock, net, related party | 8,673,509 | 8,673,509 | ||||
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 (in Shares) | (225,962) | |||||
Issuance of Series G preferred stock, related party | $ 100 | (100) | ||||
Issuance of Series G preferred stock, related party (in Shares) | 100,000 | |||||
Stock issued in connection with stock options exercised | $ 38 | 122,666 | 122,704 | |||
Stock issued in connection with stock options exercised (in Shares) | 38,090 | |||||
Conversion of Series C-3 non-voting preferred stock to common stock | $ 104 | $ (52) | (52) | |||
Conversion of Series C-3 non-voting preferred stock to common stock (in Shares) | 104,000 | (52,000) | ||||
Issuance of vested restricted stock | $ 25 | (25) | ||||
Issuance of vested restricted stock (in Shares) | 25,346 | |||||
Issuance of common stock as a result of reverse stock split rounding | $ 7 | (7) | ||||
Issuance of common stock as a result of reverse stock split rounding (in Shares) | 6,522 | |||||
Stock-based compensation | 2,439,618 | 2,439,618 | ||||
Other comprehensive income | 735 | 735 | ||||
Net loss | (16,433,074) | (16,433,074) | ||||
Balance at Dec. 31, 2019 | $ 25,665 | $ 242 | 97,257 | 218,944,268 | (195,421,172) | 23,646,260 |
Balance (in Shares) at Dec. 31, 2019 | 25,665,350 | 241,623 | ||||
Stock issued in connection with public offering, net | $ 5,111 | 21,250,059 | 21,255,170 | |||
Stock issued in connection with public offering, net (in Shares) | 5,111,110 | |||||
Stock issued in connection with ATM sale of common stock, net | $ 2,688 | 18,430,257 | 18,432,945 | |||
Stock issued in connection with ATM sale of common stock, net (in Shares) | 2,687,646 | |||||
Stock issue in connection with warrants exercised | $ 92 | 411,659 | 411,751 | |||
Stock issue in connection with warrants exercised (in Shares) | 91,500 | |||||
Issuance of vested restricted stock | $ 2 | (2) | ||||
Issuance of vested restricted stock (in Shares) | 2,490 | |||||
Stock-based compensation | 2,499,820 | 2,499,820 | ||||
Other comprehensive income | 4,749 | 4,749 | ||||
Net loss | (22,027,683) | (22,027,683) | ||||
Balance at Dec. 31, 2020 | $ 33,558 | $ 242 | $ 102,006 | $ 261,536,061 | $ (217,448,855) | $ 44,223,012 |
Balance (in Shares) at Dec. 31, 2020 | 33,558,096 | 241,623 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (22,027,683) | $ (16,433,074) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 2,499,820 | 2,439,618 |
Amortization of debt discount | 313,097 | |
Non-cash interest expense | 461,839 | |
Non-cash lease expense | 15,523 | |
Inventory reserve | 44,006 | 27,163 |
Depreciation | 127,964 | 73,286 |
Changes in operating assets and liabilities: | ||
(Increase) decrease in trade receivables | (3,089) | 10,631 |
Decrease in inventory | 149,597 | 59,285 |
Increase in prepaid expenses and other current assets | (991,754) | (67,385) |
Increase (decrease) in accounts payable | 103,333 | (1,564,381) |
Decrease in accrued expenses | (1,883,149) | (363,280) |
Decrease in deferred revenue | (2,206) | (8,823) |
Net cash used in operating activities | (21,967,638) | (15,052,024) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of short-term investments | (8,549,758) | (14,106,369) |
Maturity of short-term investments | 16,088,572 | 2,122,481 |
Purchase of equipment | (112,638) | (36,571) |
Net cash provided by (used in) investing activities | 7,426,176 | (12,020,459) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from sale of common stock from at-the-market program, net | 18,432,945 | 15,234,529 |
Proceeds from the public offering, net | 21,255,170 | |
Proceeds from exchange agreement, related party | 2,000,000 | |
Proceeds from exercise of warrants | 411,751 | 8,673,984 |
Proceeds from exercise of stock options | 122,704 | |
Payment of financing fees | (226,855) | |
Net cash provided by financing activities | 40,099,866 | 25,804,362 |
Foreign exchange effects on cash | 13,192 | (2,015) |
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 25,571,596 | (1,270,136) |
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH – BEGINNING OF YEAR | 16,525,187 | 17,795,323 |
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH – END OF YEAR | 42,096,783 | 16,525,187 |
Cash paid for interest | 33,226 | 12,552 |
Supplemental Disclosure of Non-Cash Financing and Investing 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 shares, related party | 26,733,098 | |
Issuance of common stock for vested restricted stock units | 2 | 25 |
Right-of-use asset and lease liability recognized under ASC 842 | 1,015,000 | 5,000 |
Unrealized gain (loss) from investments | (1,270) | 268 |
Conversion of preferred stock to common stock | 52 | |
Write-off of fully depreciated computer equipment | $ 47,850 |
Organization, Business and Basi
Organization, Business and Basis of Presentation | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Organization, Business and Basis of Presentation | Note 1 — Organization, Business and Basis of Presentation: Organization and Business: CorMedix Inc. (“CorMedix” or the “Company”) was incorporated in the State of Delaware on July 28, 2006. The Company is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases. In 2013, the Company formed a wholly-owned subsidiary, CorMedix Europe GmbH and in May 2020, the Company formed a wholly-owned Spanish subsidiary, CorMedix Spain, S.L.U. The Company’s primary focus is to develop its lead product candidate, DefenCath™, for potential commercialization in the United States (“U.S.”) and other key markets. The Company has in-licensed the worldwide rights to develop and commercialize DefenCath/Neutrolin®, which is a novel anti-infective solution (a formulation of taurolidine 1.35% and heparin 1000 u/ml) intended for the reduction and prevention of catheter-related infections and thrombosis in patients requiring central venous catheters in clinical settings such as hemodialysis, total parenteral nutrition, and oncology. The name DefenCath is the U.S. proprietary name conditionally approved by the U.S. Food and Drug Administration (“FDA”), while the name Neutrolin is currently used in the European Union (“EU”) and other territories where the Company has received CE-Mark approval for the commercial distribution of Neutrolin as a catheter lock solution (“CLS”) regulated as a medical device. In January 2015, the FDA designated DefenCath as a Qualified Infectious Disease Product (“QIDP”) for prevention of catheter-related blood stream infections in patients with end stage renal disease receiving hemodialysis through a central venous catheter. Catheter-related blood stream infections and clotting can be life-threatening. The QIDP designation provides five years of market exclusivity in addition to the five years granted for a New Chemical Entity upon approval of a New Drug Application (“NDA”). In addition, in January 2015, the FDA granted Fast Track designation to DefenCath Catheter Lock Solution, a designation intended to facilitate development and expedite review of drugs that treat serious and life-threatening conditions so that the approved drug can reach the market expeditiously. The Fast Track designation of DefenCath provides us with the opportunity to meet with the FDA on a more frequent basis during the development process, and also ensures eligibility to request priority review of the marketing application. In December 2015, the Company launched its Phase 3 Prospective, Multicenter, Double-blind, Randomized, Active Control Study to Demonstrate Safety & Effectiveness of DefenCath/Neutrolin in Preventing Catheter-related Bloodstream Infection in Subjects on Hemodialysis for End Stage Renal Disease (“LOCK-IT-100”), in patients with hemodialysis catheters in the U.S. The clinical trial was designed to demonstrate the safety and effectiveness of DefenCath compared to the standard of care CLS, Heparin, in preventing CRBSIs. The primary endpoint for the trial assessed the incidence of CRBSI and time to CRBSI for each study subject. Secondary endpoints were catheter patency, which was defined as required use of tissue plasminogen activating factor, or tPA, or removal of catheter due to dysfunction, and removal of catheter for any reason. As previously agreed with the FDA, an interim efficacy analysis was performed when the first 28 potential CRBSI cases were identified in our LOCK-IT-100 study that occurred through early December 2017. Based on these first 28 cases, there was a highly statistically significant 72% reduction in CRBSI by DefenCath relative to the active control of heparin (p=0.0034). Because the pre-specified level of statistical significance was reached for the primary endpoint and efficacy had been demonstrated with no safety concerns, the LOCK-IT-100 study was terminated early. The study continued enrolling and treating subjects until study termination, and the final analysis was based on a total of 795 subjects. In a total of 41 cases, there was a 71% reduction in CRBSI by DefenCath relative to heparin, which was highly statistically significant (p=0.0006), with a good safety profile. The FDA granted the Company’s request for a rolling submission and review of the NDA which is designed to expedite the approval process for products being developed to address an unmet medical need. Although the FDA usually requires two pivotal clinical trials to provide substantial evidence of safety and effectiveness for approval of an NDA, the FDA will in some cases accept one adequate and well-controlled trial, where it is a large multicenter trial with a broad range of subjects and investigation sites with procedures to include trial quality that has demonstrated a clinically meaningful and statistically very persuasive effect on prevention of a disease with potentially serious outcome. In March 2020, the Company began the modular submission process for the NDA for DefenCath for the prevention of CRBSI in hemodialysis patients, and in August 2020, the FDA accepted for filing the DefenCath NDA. The FDA also granted the Company’s request for priority review, which provides for a six-month review period instead of the standard ten-month review period. As the Company announced in March 2021, the FDA informed the Company that it will not approve the NDA for DefenCath in its present form. The FDA noted concerns at the third-party manufacturing facility after a review of records requested by the FDA and provided by the manufacturing facility. The Company is working with the manufacturing facility to develop plans for resolution of the deficiencies. Additionally, the FDA is requiring a manual extraction study to demonstrate that the labeled volume can be consistently withdrawn from the vials despite an existing in-process control to demonstrate fill volume within specifications. The Company expects to be able to complete this requirement expeditiously. Satisfactory resolution of these issues is required for approval of the DefenCath NDA by a pre-approval inspection and/or adequate manufacturing facility responses addressing these concerns. If an inspection is required, the Company may encounter delays in obtaining FDA approval because the FDA is currently facing a backlog due to the pandemic and is actively working to define an approach for scheduling outstanding inspections once safe travel may resume. The Company will request a meeting with the FDA, which the Company estimates will occur in mid-April, to obtain agreement with the FDA on the proposed resolutions of the deficiencies. The FDA did not request additional clinical data and did not identify any deficiencies related to the data submitted on the efficacy or safety of DefenCath from LOCK-IT-100. In draft labeling discussed with the FDA, the FDA added that the initial approval will be for the limited population of patients with kidney failure receiving chronic hemodialysis through a central venous catheter. This is consistent with our request for approval pursuant to the Limited Population Pathway for Antibacterial and Antifungal Drugs (“LPAD”). LPAD, passed as part of the 21 st The Company intends to pursue additional indications for DefenCath use as a CLS in populations with an unmet medical need that also represent a significant market opportunity. For example, the Company intends to pursue marketing authorization in the U.S. for use as a CLS to reduce CRBSIs in oncology and total parenteral nutrition patients using a central venous catheter. In addition to DefenCath, the Company is sponsoring a pre-clinical research collaboration for the use of taurolidine 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 in children. The Company may seek one or more strategic partners or other sources of capital to help develop and commercialize taurolidine for the treatment of neuroblastoma in children. The Company is also evaluating opportunities for the possible expansion of taurolidine as a platform compound for use in certain medical devices. Patent applications have been filed in several indications, including wound closure, surgical meshes, and wound management. The Company was granted a deferral by the FDA under the Pediatric Research Equity Act (“PREA”), that requires sponsors to conduct pediatric studies for NDAs for a new active ingredient, such as taurolidine in DefenCath, unless a waiver or deferral is obtained from the FDA. A deferral acknowledges that a pediatric assessment is required but permits the applicant to submit the pediatric assessment after the submission of an NDA. The Company has made a commitment to conduct the pediatric study after approval of the NDA for use in adult hemodialysis patients. Pediatric studies for an approved product conducted under PREA may qualify for pediatric exclusivity, which if granted would provide an additional six months of marketing exclusivity. DefenCath would then have the potential to receive a total marketing exclusivity period of 10.5 years, including exclusivity pursuant to NCE and QIDP. The FDA regards taurolidine as a new chemical entity and therefore, it is currently an unapproved new drug. The Company might in the future pursue product candidates that would involve devices impregnated with taurolidine, and the Company believes that at the current time such products would be combination products subject to device premarket submission requirements (while subject also, under review by the FDA, to the standards for drug approvability). Consequently, given that there is no appropriate predicate medical device currently marketed in the U.S. on which a 510(k) approval process could be based and that taurolidine is not yet approved in any application, the Company anticipates that it would be required to submit a premarket approval application (“PMA”) for marketing authorization for any medical device indications that we may pursue for devices containing taurolidine. In the event that an NDA for DefenCath is approved by the FDA, the regulatory pathway for these medical device product candidates may be revisited with the FDA. Although there may be no appropriate predicate, de novo Class II designation can be proposed, based on a risk assessment and a reasonable assurance of safety and effectiveness. In the European Union (“EU”), Neutrolin is regulated as a Class 3 medical device. In July 2013, the Company received CE Mark approval for Neutrolin. In December 2013, the Company commercially launched Neutrolin in Germany for the prevention of CRBSI, and maintenance of catheter patency in hemodialysis patients using a tunneled, cuffed central venous catheter for vascular access. To date, Neutrolin is registered and may be sold in certain European Union and Middle Eastern countries for such treatment. In September 2014, the TUV-SUD and The Medicines Evaluation Board of the Netherlands (“MEB”), granted a label expansion for Neutrolin to include use in oncology patients receiving chemotherapy, intravenous (“IV”) hydration and IV medications via CVC for the EU. In December 2014, the Company received approval from the Hessian District President in Germany to expand the label for these same expanded indications. The expansion also adds patients receiving medication and IV fluids via CVC in intensive or critical care units (cardiac care unit, surgical care unit, neonatal critical care unit, and urgent care centers). An indication for use in total parenteral nutrition was also approved. In September 2019, the Company’s registration with the Saudi Arabia Food and Drug Administration, or the SFDA, expired. As a result, the Company cannot sell Neutrolin in Saudi Arabia. The Company intends to complete the documentation required to renew its registration with the SFDA, however, the Company cannot predict how long the renewal process will take. There is no assurance that the registration will be renewed by the SFDA. 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 our 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 our 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 our 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 consolidated financial statements and in this report have been adjusted to reflect the reverse stock split, reclassification, combination and change for all periods presented. The Company is using its current cash resources for certain pre-launch activities. Commercial preparations are dependent on the Company’s ability to raise sufficient additional funds through various potential sources, such as equity, debt financings, and/or strategic relationships and potential strategic transactions. The Company can provide no assurances that financing or strategic relationships will be available on acceptable terms, or at all, to complete its clinical development program for DefenCath. The novel coronavirus has been declared a pandemic and has spread to multiple global regions. The outbreak and government measures taken in response have also had a significant impact, both direct and indirect, on businesses and commerce, as worker shortages have occurred; supply chains have been disrupted; facilities and production have been suspended; and demand for certain goods and services, such as medical services and supplies, has spiked, while demand for other goods and services, such as travel, has fallen. In response to the COVID-19 outbreak, “shelter in place” orders and other public health guidance measures have been implemented across much of the United States, Europe and Asia, including in the locations of the Company’s offices, clinical trial sites, key vendors and partners. The Company’s program timelines may be negatively affected by COVID-19, which could materially and adversely affect its business, financial conditions and results of operations. |
Liquidity and Uncertainties
Liquidity and Uncertainties | 12 Months Ended |
Dec. 31, 2020 | |
Liquidity And Uncertainties [Abstract] | |
Liquidity and Uncertainties | Note 2 — Liquidity and Uncertainties: The consolidated financial statements have been prepared in conformity with generally accepted accounting principles 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 December 31, 2020, the Company had an accumulated deficit of $217.4 million, and incurred net losses of $22.0 million and $16.4 million for the years ended December 31, 2020 and 2019, respectively. Based on the Company’s current development plans for DefenCath/Neutrolin in both the U.S. and foreign markets and its other operating requirements, the Company’s existing cash and cash equivalents and short-term investments at December 31, 2020 are expected to fund its operations for at least twelve months after the filing date of this report after taking into consideration the $41.5 million of net proceeds received in January and February 2021 from the At-the-Market Issuance Sales Agreement (the “ATM program”) (see Note 11) and the costs for the initial preparations for the commercial launch for DefenCath. 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, potential strategic transactions or out-licensing of its products in order to commercially launch DefenCath 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. As of the filing date of this Annual Report on Form 10-K, the Company has no available balance under its ATM program and has $50.0 million available under its current shelf registration for the issuance of equity, debt or equity-linked securities (see Note 8). 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. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 3 — Summary of Significant Accounting Policies: Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America 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 consolidated financial statements include the accounts of the Company, CorMedix Europe GmbH and CorMedix Spain, S.L.U. its wholly owned subsidiaries. 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 following table is the reconciliation of the accounting standard that modifies certain aspects of the recognition, measurement, presentation and disclosure of financial instruments as shown on the Company’s consolidated statement of cash flows: December 31, 2020 2019 Cash and cash equivalents $ 41,905,469 $ 16,350,237 Restricted cash 191,314 174,950 Total cash, cash equivalents and restricted cash $ 42,096,783 $ 16,525,187 The appropriate classification of marketable securities is determined at the time of purchase and reevaluated as of each balance sheet date. Investments in marketable debt and equity securities classified as available-for-sale are reported at fair value. Fair value is determined using quoted market prices in active markets for identical assets or liabilities or quoted prices for similar assets or liabilities or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Changes in fair value that are considered temporary are reported net of tax in other comprehensive income (loss). Realized gains and losses, amortization of premiums and discounts and interest and dividends earned are included in income (expense). For declines in the fair value of equity securities that are considered other-than-temporary, impairment losses are charged to other (income) expense, net. The Company considers available evidence in evaluating potential impairments of its investments, including the duration and extent to which fair value is less than cost. There were no deemed permanent impairments at December 31, 2020 or 2019. 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 December 31, 2020 and 2019, all of the Company’s investments had contractual maturities which were less than one year. The following table summarizes the amortized cost, unrealized gains and losses and the fair value at December 31, 2020 and 2019: Amortized Cost Gross Unrealized Losses Gross Unrealized Gains Fair Value December 31, 2020: Money Market Funds and Cash Equivalents $ 3,182,762 $ (81 ) $ 8 $ 3,182,689 Corporate Securities 3,565,501 (1,005 ) 3 3,564,499 Commercial Paper 879,501 - 72 879,573 Subtotal 4,445,002 (1,005 ) 75 4,444,072 Total December 31, 2020 $ 7,627,764 $ (1,086 ) $ 83 $ 7,626,761 December 31, 2019: Money Market Funds and Cash Equivalents $ 3,472,043 $ - $ 51 $ 3,472,094 U.S. Government Agency Securities 2,691,091 (42 ) 869 2,691,918 Corporate Securities 6,058,265 (1,438 ) 440 6,057,267 Commercial Paper 3,234,583 (16 ) 405 3,234,972 Subtotal 11,983,939 (1,496 ) 1,714 11,984,157 Total December 31, 2019 $ 15,455,982 $ (1,496 ) $ 1,765 $ 15,456,251 Fair Value Measurements The Company’s financial instruments recorded in the consolidated balance sheets include cash and cash equivalents, accounts receivable, investment securities, accounts payable and accrued expenses. The carrying value of certain financial instruments, primarily cash and cash equivalents, accounts receivable, accounts payable, and accrued expenses approximate their estimated fair values based upon the short-term nature of their maturity dates. The Company’s senior secured convertible note (prior to its extinguishment in August 2019) falls into the Level 3 category within the fair value level hierarchy. The fair value was determined using market data for valuation. 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, which is set out below. 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. ● 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 as of December 31, 2020 and 2019: Carrying Value Level 1 Level 2 Level 3 December 31, 2020: Money Market Funds and Cash Equivalents $ 3,182,689 $ 3,182,689 $ - $ - Corporate Securities 3,564,499 - 3,564,499 - Commercial Paper 879,573 - 879,573 - Subtotal 4,444,072 - 4,444,072 - Total December 31, 2020 $ 7,626,761 $ 3,182,689 $ 4,444,072 $ - December 31, 2019: Money Market Funds and Cash Equivalents $ 3,472,094 3,472,094 - - U.S. Government Agency Securities 2,691,918 2,691,918 - - Corporate Securities 6,057,267 - 6,057,267 - Commercial Paper 3,234,972 - 3,234,972 - Subtotal 11,984,157 2,691,918 9,292,239 - Total December 31, 2019 $ 15,456,251 $ 6,164,012 $ 9,292,239 $ - Foreign Currency Translation and Transactions The 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 subsidiaries, whose functional currency is the EURO, foreign currency asset and liability amounts, if any, 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 year. Translation gains and losses are included in other comprehensive income (loss). The Company had a foreign currency translation gain of $6,020 in 2020 and a gain of $467 in 2019. 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. Geographic Information The following table summarizes the geographic information: December 31, 2020 2019 Reported revenues $ 239,231 $ 283,266 Revenues attributable to European and Mideast operations, which are based in Germany 237,025 274,443 Total assets 49,308,303 29,475,910 Total assets located in the United States, with the remainder in the European Union $ 48,928,244 $ 28,919,276 Restricted Cash As of December 31, 2020, and 2019 the Company has restricted cash in connection with the patent and utility model infringement proceedings against TauroPharm (see Note 7). The Company was required by the District Court Mannheim to provide a security deposit of approximately $135,000 (€110,000) to cover legal fees in the event TauroPharm is entitled to reimbursement of these costs. The Company furthermore had to provide a deposit in the amount of $44,000 (€36,000) and $12,000 (€10,000) for the first and second instances, respectively, in connection with the unfair competition proceedings in Cologne. During the year ended December 31, 2020, the Company reimbursed TauroPharm approximately $30,000 for the costs in connection with the utility model infringement proceedings. In January 2021, approximately $48,000 (€40,000) was released by the court to the Company’s account which will be deducted from the restricted cash. 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, pre-clinical 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 DefenCath product. Inventories consist of the following: December 31, 2020 2019 Raw materials $ - $ 6,893 Finished goods 317,733 461,735 Inventory reserve (174,169 ) (130,163 ) Total $ 143,564 $ 338,465 Property and Equipment Property and equipment consist primarily of furnishings, fixtures, leasehold improvements, office equipment and computer equipment all of which are recorded at cost. Depreciation is provided for by the straight-line method over the estimated useful lives of the related assets. Leasehold improvements are amortized using the straight-line method over the remaining lease term or the life of the asset, whichever is shorter. Property and equipment, as of December 31, 2020 and 2019 were $111,499 and $122,130, respectively, net of accumulated depreciation of $303,279 and $244,328, respectively. Depreciation and amortization of property and equipment is included in selling, general and administrative expenses. Description Estimated Useful Life Office equipment and furniture 5 years Leasehold improvements 7 years Computer equipment 5 years Computer software 3 years 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 (included in accrued expenses), and operating lease liabilities, net of current portion, on the consolidated balance sheet (see Note 10). 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: December 31, 2020 2019 Professional and consulting fees $ 146,129 $ 214,777 Accrued payroll and payroll taxes 2,490,441 1,287,047 Clinical trial related 2,187 2,435,953 Manufacturing development related 143,780 806,032 Other 141,814 54,666 Total $ 2,924,351 $ 4,798,475 Revenue Recognition The Company uses Accounting Standards Codification (“ASC”) 606, “ Revenue from Contracts with Customers,” The Company recognizes net sales upon shipment of product to the dialysis centers 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 South Korea. Upon execution, 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 South Korea (the “Territory”). The term of the Wonik Agreement commenced on August 8, 2014 and will continue for three years after the first commercial sale of Neutrolin in the Territory. The non-refundable up-front payment has been recorded as deferred revenue and will be recognized as revenue on a straight-line basis over the contractual term of the Agreement. Deferred revenue related to this agreement was fully amortized at December 31, 2020. Loss Per Common Share Basic loss per common share excludes dilution and is computed by dividing net loss by the weighted average number of common shares outstanding during the period. Diluted 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. The Company’s outstanding shares of Series E preferred stock entitle the holders to receive dividends on a basis equivalent to the dividends paid to holders of common stock. As a result, the Series E preferred stock meet the definition of participating securities requiring the application of the two-class method. Under the two-class method, earnings available to common shareholders, including both distributed and undistributed earnings, are allocated to each class of common stock and participating securities according to dividends declared and participating rights in undistributed earnings, which may cause diluted earnings per share to be more dilutive than the calculation using the treasury stock method. No loss has been allocated to these participating securities since they do not have contractual obligations that require participation in the Company’s losses. Since the Company has only incurred losses, basic and diluted loss per share are the same as potentially dilutive shares have been excluded from the calculation of diluted net loss per share as their effect would be anti-dilutive. The shares outstanding at the end of the respective periods presented below were excluded from the calculation of diluted net loss per share due to their anti-dilutive effect: Number of Shares of Common Stock Issuable At December 31, 2020 2019 Series C non-voting preferred stock 104,000 104,000 Series E voting preferred stock 391,953 391,953 Series G voting preferred stock 5,560,137 5,560,137 Restricted stock units - 2,490 Shares issuable for payment of deferred board compensation 48,909 33,597 Shares underlying outstanding warrants 183,148 341,328 Shares underlying outstanding stock options 2,447,687 1,376,394 Total potentially dilutive shares 8,735,834 7,809,899 Stock-Based Compensation Share-based compensation cost is measured at grant date, based on the estimated fair value of the award using the Black-Scholes option pricing model for options with service or performance-based conditions. Stock-based compensation is recognized as expense over the requisite service period on a straight-line basis or when the achievement of the performance condition is probable. Research and Development Research and development costs are charged to expense as incurred. Research and development include fees associated with operational consultants, contract clinical research organizations, contract manufacturing organizations, clinical site fees, contract laboratory research organizations, contract central testing laboratories, licensing activities, and allocated executive, human resources and facilities expenses. The Company accrues for costs incurred as the services are being provided by monitoring the status of the trial and the invoices received from its external service providers. As actual costs become known, the Company adjusts its accruals in the period when actual costs become known. Costs related to the acquisition of technology rights and patents for which development work is still in process are charged to operations as incurred and considered a component of research and development expense. Income Taxes Deferred tax assets and liabilities are recognized for the future tax consequences attributable to temporary differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Valuation allowances are established when it is more likely than not that some or all of the deferred tax assets will not be realized. Recently Adopted Authoritative Pronouncements In June 2016, the Financial Accounting Standards Board (“FASB”) issued new guidance which replaces the incurred loss impairment methodology in current GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. This adoption on January 1, 2020 did not have a material impact on the Company’s consolidated financial statements. In August 2018, the FASB issued new guidance which modifies the disclosure requirements on fair value measurements. The guidance was effective for the Company beginning in the first quarter of fiscal year 2020. This adoption on January 1, 2020 did not have a material impact on the Company’s consolidated financial statements. In November 2018, the FASB issued new guidance to clarify the interaction between the authoritative guidance for collaborative arrangements and revenue from contracts with customers. The new guidance clarifies that, when the collaborative arrangement participant is a customer in the context of a unit-of-account, revenue from contracts with customers guidance should be applied, adds unit-of-account guidance to collaborative arrangements guidance, and, in a transaction with a collaborative arrangement participant who is not a customer, precludes presenting the transaction together with revenue recognized under contracts with customers. The guidance was effective for the Company beginning in the first quarter of fiscal year 2020. This adoption on January 1, 2020 did not have a material impact on the Company’s consolidated financial statements. In November 2019, the FASB issued new guidance which requires that an entity measure and classify share-based payment awards granted to a customer by applying the guidance in FASB ASC 718. The guidance was effective for the Company beginning in the first quarter of fiscal year 2020. This adoption on January 1, 2020 did not have a material impact on the Company’s consolidated financial statements. Recent Authoritative Pronouncements In December 2019, the FASB issued new guidance which removes certain exceptions to the general principles of the accounting for income taxes and also improves consistent application of and simplification of other areas when accounting for income taxes. The guidance is effective for the company beginning in the first quarter of fiscal year 2021. Early adoption is permitted. The Company is assessing the impact of adopting this guidance on its consolidated financial statements. |
Related Party Transactions_
Related Party Transactions: | 12 Months Ended |
Dec. 31, 2020 | |
Related Party Transactions [Abstract] | |
Related Party Transactions: | Note 4 — Related Party Transactions: On August 14, 2019, the Company entered into an exchange agreement (the “Exchange Agreement”) with Manchester Securities Corp. (“Manchester”), an existing institutional investor and 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 Notes 6 and 8). On September 6, 2019, the Company completed the transactions contemplated by the Exchange Agreement. On December 31, 2018, the Company entered into a securities purchase agreement with Elliott, for the purchase and sale of a 10% senior secured convertible note in the aggregate principal amount of $7,500,000 and a warrant to purchase up to an aggregate of 90,000 shares of the Company’s common stock, for gross proceeds of $7,500,000 (see Note 6). The warrant with a grant date fair value of $433,365, is immediately exercisable, has an exercise price of $7.50 per share, subject to adjustment in the event of stock dividends and distributions, stock splits, stock combinations, or reclassifications affecting our common stock, and has a term of five years. The note has a conversion price of $7.50 per share. The conversion price is subject to appropriate adjustment in the event of stock dividends and distributions, stock splits, stock combinations, or reclassifications affecting our common stock. As of December 31, 2019, this note is no longer outstanding as a result of the Exchange Agreement (see Notes 6 and 8). 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, which was canceled in connection with the terms of the Exchange Agreement, had an exercise price of $0.005 (see Note 6). The incremental value of the warrant extended was immaterial. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 5 — Income Taxes: The Company’s U.S. and foreign loss before income taxes are set forth below: December 31, 2020 2019 United States $ (20,605,821 ) $ (20,943,703 ) Foreign (591,257 ) (550,149 ) Total $ (27,197,078 ) $ (21,493,852 ) There were no current or deferred income tax provision for the years ended December 31, 2020 and 2019 because the Company has incurred operating losses since inception. The Company’s deferred tax assets consist of the following: December 31, 2020 2019 Net operating loss carryforwards – Federal $ 38,986,000 $ 33,494,000 Net operating loss carryforwards – State 2,958,000 6,171,000 Net operating loss carryforwards – Foreign 2,455,000 2,128,000 Capitalized licensing fees 600,000 757,000 Stock-based compensation 3,358,000 2,892,000 Accrued compensation 102,000 349,000 Other 21,000 24,000 Totals 48,480,000 45,815,000 Less valuation allowance (48,480,000 ) (45,815,000 ) Deferred tax assets $ - $ - The Company had the following potentially utilizable net operating loss tax carryforwards: December 31, 2020 2019 Federal $ 185,650,000 $ 155,400,000 State $ 41,600,000 $ 82,700,000 Foreign $ 8,185,000 $ 7,091,000 The net operating losses generated will start to expire in 2026 for Federal purposes whereas the operating losses for state purposes will begin expiring in 2038. The Tax Cuts and Jobs Act of 2017 (the “Act”) limits the net operating loss deduction to 80% of taxable income for losses arising in tax years beginning after December 31, 2017. However, the net operating losses now have an indefinite carryforward as opposed to the former 20-year carryforward. The foreign net operating loss tax carryforwards do not expire. Our federal and state operating loss carryforwards include windfall tax deductions from stock option exercises. The utilization of the Company’s net operating losses may be subject to a substantial limitation due to the “change of ownership provisions” under Section 382 of the Internal Revenue Code and similar state provisions. Such limitation may result in the expiration of the net operating loss carryforwards before their utilization. The Company’s foreign earnings are derived from its German subsidiary. The Company does not expect any foreign earnings to be repatriated in the U.S. in the near future. The Company’s effective tax rate varied from the statutory rate as follows: December 31, 2020 2019 Statutory federal tax rate 21.0 % 21.0 % State income tax rate (net of federal) 4.3 % 7.2 % Effect of foreign operations 0.7 % 0.8 % Federal deferred tax rate change 0.5 % 0.1 % NJ NOL adjustment 2.9 % 6.2 % Other permanent differences (0.6 )% (0.4 )% Effect of valuation allowance (9.8 )% (11.3 )% Effective tax rate 19.0 % 23.6 % In assessing the realizability of deferred tax assets, management considers whether it is more-likely-than-not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income of the appropriate character during the periods in which those temporary differences become deductible and the loss carryforwards are available to reduce taxable income. In making its assessment, the Company considered all sources of taxable income including carryback potential, future reversals of existing deferred tax liabilities, prudent and feasible tax planning strategies, and lastly, objectively verifiable projections of future taxable income exclusive of reversing temporary differences and carryforwards. At December 31, 2020 and 2019, the Company maintained a full valuation allowance against its net deferred tax assets. The Company will continue to assess all available evidence during future periods to evaluate the realization of its deferred tax assets. The following table presents the changes in the deferred tax asset valuation allowance for the periods indicated: Year Ended Balance at Beginning of Year Increase (Decrease) Charged (Credited) to Income Taxes (Benefit) Increase (Decrease) Charged (Credited) to OCI Balance at End of Year December 31, 2020 $ 45,815,000 $ 2,696,000 $ (31,000 ) $ 48,480,000 December 31, 2019 $ 43,396,000 $ 2,449,000 $ (30,000 ) $ 45,815,000 Accounting for uncertainty in income taxes requires uncertain tax positions to be classified as non-current income tax liabilities unless they are expected to be paid within one year. The Company has concluded that there are no uncertain tax positions requiring recognition in its consolidated financial statements as of December 31, 2020 and 2019. The Company recognizes interest and penalties related to uncertain tax positions if any as a component of income tax expense. The Company files income tax returns in the U.S. federal, state and foreign jurisdictions. Tax years 2014 to 2018 remain open to examination for both the U.S. federal and state jurisdictions. Tax years 2015 to 2018 remain open for Germany. During the years ended December 31, 2020 and 2019, the Company received net proceeds of $5,169,395 and $5,060,778, respectively, from the sale of most of its remaining unused New Jersey net operating losses (“NOL”) eligible for sale under the State of New Jersey’s Economic Development Authority’s New Jersey Technology Business Tax Certificate Transfer program (“NJEDA Program”). The NJEDA Program allowed the Company to sell $5,529,000 of its total $6,018,000 in available NOL tax benefits for the state fiscal year 2019 and $5,413,000 of its total $6,085,000 for the state fiscal year 2018. |
Senior Secured Convertible Note
Senior Secured Convertible Note, Related Party: | 12 Months Ended |
Dec. 31, 2020 | |
Debt Disclosure [Abstract] | |
Senior Secured Convertible Note, Related Party: | Note 6 — 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 10% senior secured convertible note in the aggregate principal amount of $7,500,000 and a warrant to purchase up to an aggregate of 90,000 shares of the Company’s common stock, for gross proceeds of $7,500,000. For year ended December 31, 2019, $462,000 was recognized as interest expense on the consolidated statement of operations and comprehensive loss. The senior secured convertible note, including accrued interest, 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. 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 16, 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, (see Note 8). 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 $3,000,000 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 $7,500,000 in gross proceeds, along with the legal fees of approximately $267,000, 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 $7,000,000, 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 year ended December 31, 2019, approximately $313,000 was recognized as amortization of debt discount and is included in interest expense on the 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,” A summary of the assumptions used in the Black Scholes pricing model are as follows: Conversion Option New Warrants Expected term (months) 36 60 Volatility 161.5% 161.5% Dividend yield 0% 0% Risk-free interest rate 2.43% 2.48% 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 consolidated statement of operations and comprehensive loss for the year ended December 31, 2019 (see Note 8). |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 7 — 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 the ultimate outcome of either of these related matters. At present, the EPO has revoked the Prosl European Patent as invalid, and the Company has filed an appeal, which is currently pending. 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 were 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. 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. 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, had 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 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 Court 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. On April 28, 2020, the Company filed a withdrawal of the complaint on the German utility model, thereby waiving its claims on these proceedings. 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 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. 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 to cover legal fees in the event TauroPharm is entitled to reimbursement of these costs. As of December 31, 2020, the aggregate deposit was approximately $191,000, which the Company recorded as restricted cash on the consolidated balance sheets. During the year ended December 31, 2020, costs in connection with the utility model infringement proceedings of approximately $30,000 was reimbursed to TauroPharm . Commitments 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 December 31, 2020 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 being $2,500,000 as of December 31, 2020 and 2019. Events that trigger milestone payments include but are not limited to the reaching of various stages of regulatory approval and upon achieving certain worldwide net sales amounts. There were no milestones achieved during the years ended December 31, 2020 and 2019. The NDP License Agreement may be terminated by the Company on a country-by-country basis upon 60 days prior written notice. If the NDP License Agreement is terminated by either party, the Company’s rights to the NDP Technology will revert back to NDP. Other The Company entered into a seven-year operating lease agreement in March 2020 for an office space at 300 Connell Drive, Berkeley Heights, New Jersey 07922. The lease agreement, with a monthly average of approximately $17,000 commenced on September 16, 2020. The Company’s sublease on its previous premises at 400 Connell Drive, Berkeley Heights, New Jersey 07922 terminated on November 30, 2020 (see Note 10). |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2020 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity | Note 8 — Stockholders’ Equity: Common Stock: On July 30, 2020, the Company completed an underwritten public offering of its common stock, par value $0.001 per share, which yielded net proceeds of approximately $21.3 million. The public offering was made pursuant to an underwriting agreement with SunTrust Robinson Humphrey, Inc. and JMP Securities LLC (collectively, the “Underwriters”), relating to the issuance and sale of an aggregate of 5,111,110 shares of common stock, including 666,666 shares of common stock pursuant to the full exercise of the Underwriters’ option to purchase additional shares, at a public offering price of $4.50 per share. The offering was made pursuant to the Company’s effective registration statement on Form S-3 Registration Statement No. 333-223562 previously filed with and declared effective by the SEC and a prospectus supplement and accompanying prospectus filed with the SEC. The Company had a prior sales agreement with FBR Securities, Inc., (formerly known as B. Riley FBR, Inc.) (“B. Riley”) for its ATM program, which 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. On March 9, 2018, the Company entered into a new agreement with B. Riley for the sale of up to $14.7 million of the Company’s common stock under the ATM program, pursuant to a registration statement filed on March 9, 2018 for an aggregate of $70 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. The ATM program amount was increased by $25.0 million in November 2018. Under the ATM program, the Company may issue and sell common stock from time to time through B. Riley acting as agent, subject to limitations imposed by the Company and subject to B. Riley’s acceptance, such as the number or dollar amount of shares registered under the registration statement to which the offering relates. B. Riley is entitled to a commission of up to 3% of the gross proceeds from the sale of common stock sold under the ATM program. During the years ended December 31, 2020 and 2019, the Company sold 1,854,970 and 1,768,012 shares of common stock under the new and expired ATM programs, respectively, and realized net proceeds of approximately $11.4 million and $15.2 million during the years ended December 31, 2020 and 2019, respectively. At December 31, 2020, this current ATM program and the current shelf registration for the issuance of equity, debt or equity-linked securities has been exhausted. In November 2020, the Company filed a new registration statement, under which the Company could issue and sell up to an aggregate of $100.0 million of shares of its common stock, $0.001 par value per share. On November 27, 2020, the Company entered into an Amended and Restated At Market Issuance Sales Agreement (“Amended Sales Agreement”) with B. Riley and Needham & Company, LLC (“Needham”), together with B. Riley, acting as sales agents (“Sales Agent”). The Amended Sales Agreement relates to the sale of shares of up to $25.0 million of the Company’s common stock under its ATM program, of which the Company may issue and sell common stock from time to time through the Sales Agent, subject to limitations imposed by the Company and subject to Sales Agent’s acceptance, such as the number or dollar amount of shares registered under the registration statement to which the offering relates. Sales Agent is entitled to a commission of up to 3% of the gross proceeds from the sale of common stock sold under the ATM program. During the year ended December 31, 2020, the Company sold 832,676 shares of common stock under the Amended Sales Agreement at the weighted average price of $8.69 per share and realized net proceeds of approximately $7.0 million. At December 31, 2020, the Company had approximately $17.8 million available under the Amended Sales Agreement and $75.0 million available under its current shelf registration for the issuance of equity, debt or equity-linked securities unrelated to the Amended Sales Agreement. Restricted Stock Units During the year ended December 31, 2020 the Company did not grant any restricted stock units (“RSUs”) and granted an aggregate of 24,850 RSUs during the year ended December 31, 2019 to its officers and 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 year ended December 31, 2020 and 2019, compensation expense recorded for these RSUs was $11,000 and $198,000, respectively. There was no unrecognized compensation expense as of December 31, 2020 as all RSU’s outstanding had vested. At December 31, 2020, there are no RSUs outstanding. During the years ended December 31, 2020 and 2019, the Company issued an aggregate of 2,490 and 25,346 shares of its common stock upon the vesting of restricted stock units issued to the Company’s board of directors, respectively. 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 December 31, 2020 As of December 31, 2019 Preferred Shares Outstanding Liquidation Preference Total Liquidation Preference Preferred Shares Outstanding Liquidation Preference Total Liquidation Preference Series C-3 52,000 $ 10.00 $ 520,000 52,000 $ 10.00 $ 520,000 Series E 89,623 $ 49.20 $ 4,409,452 89,623 $ 49.20 $ 4,409,452 Series G 100,000 $ 187.36 $ 18,736,452 100,000 $ 187.36 $ 18,736,452 Total 241,623 $ 23,665,904 241,623 $ 23,665,904 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. 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, the Company 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. The following rights, privileges, terms and condition apply to the outstanding preferred stock at December 31, 2020: Series C-3 Non-Voting Preferred Stock Rank. Conversion. Liquidation Preference. Voting Rights. Dividends Redemption Listing Fundamental Transactions Series E Voting Convertible Preferred Stock Rank. Conversion. Liquidation Preference. Voting Rights. Dividends. Redemption. Listing. Fundamental Transactions. Debt Restriction. Other Covenants. Purchase Rights. Series G Voting Convertible Preferred Stock Rank Conversion Liquidation Preference Voting Rights Dividends Redemption Listing Fundamental Transactions Debt Restriction Other Covenants Purchase Rights Stock Options: On November 26, 2019, the Company’s shareholders approved the CorMedix Inc. 2019 Omnibus Stock Incentive Plan (the “2019 Plan”). Pursuant to the 2019 Plan and subject to certain adjustments as described below, the Company may issue up to 3,000,000 shares of its common stock, plus any shares that remain available for grant under its 2013 Stock Incentive Plan (the “2013 Plan”) as of the effective date (up to a maximum carry-forward of 522,606 shares plus any outstanding options under the 2013 Plan that were canceled, forfeited and expired after the approval of the 2019 Plan), as long-term equity incentives to the Company’s employees, consultants, and directors. The long-term incentives may be in the form of stock options, stock appreciation rights, restricted stock, restricted stock units, dividend equivalent rights, or other rights or benefits (collectively, stock rights) to employees, consultants, and directors of the Company or a related entity (collectively, participants). The Company believes that the effective use of long- term equity incentives is essential to attract, motivate, and retain employees, consultants and directors, to further align participants’ interests with those of the Company’s stockholders, and to provide participants incentive compensation opportunities that are competitive with those offered by other companies in the same industry and locations as the Company. The 2019 Plan is a new equity compensation plan for the Company’s employees, consultants, and directors which replaced the 2013 Plan. The 2013 Plan and the Amended and Restated 2006 Stock Incentive Plan are referred to collectively as the “Prior Plans”. No further awards will be granted under the Prior Plans after the approval of the 2019 Plan. Awards outstanding under the Prior Plans will remain outstanding in accordance with their terms and the Prior Plans. During the year ended December 31, 2020, the Company granted ten-year qualified and non-qualified stock options to its officers, directors, employees and consultants covering an aggregate of 1,111,984 shares of the Company’s common stock under the 2019 Plan. The weighted average exercise price of these options is $5.11 per share. During the year ended December 31, 2019, the Company granted ten-year qualified and non-qualified stock options to its officers, directors, employees and consultants covering an aggregate of 496,300 shares of the Company’s common stock under the 2013 Plan. The weighted average exercise price of these options is $7.64 per share. During the years ended December 31, 2020 and 2019, total compensation expense for stock options issued to employees, directors, officers and consultants was $2,489,000 and $2,242,000, respectively. As of December 31, 2020, there was $3,284,000 total unrecognized compensation expense related to unvested stock options granted which expense is expected to be recognized over an expected remaining weighted average period of 1.7 years. All share-based awards are recognized on a straight-line method, assuming all awards granted will vest. Forfeitures of share-based awards are recognized in the period in which they occur. The fair value at grants dates of the grants issued subject to service and performance-based vesting conditions were determined using the Black-Scholes option pricing model with the following assumptions: Year Ended December 31, 2020 2019 Risk-free interest rate 0.27% - 1.67% 1.51% - 2.74% Expected volatility 102.7% - 107.9% 103% - 110% Expected term (years) 5 – 10 years 5-10 years Expected dividend yield 0.0% 0.0% Weighted-average grant date fair value of options granted during the period $3.59 $6.11 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 year ended December 31, 2020: Shares Underlying Stock Options Weighted- Weighted- Aggregate Intrinsic Value Outstanding at beginning of year 1,376,394 $ 8.98 6.8 $ 1,232,545 Granted 1,111,984 $ 5.11 2,585,172 Expired/Canceled (6,891 ) $ 12.53 - Forfeited (33,800 ) $ 8.51 9,000 Outstanding at end of year 2,447,687 $ 7.22 7.1 $ 3,872,092 Vested at end of year 1,418,990 $ 8.56 5.6 $ 1,683,965 Expected to vest in the future 1,028,697 $ 5.36 9.1 $ 2,188,127 No stock options were exercised during the year ended December 31, 2020 and for the year ended December 31, 2019, the total intrinsic value of stock options exercised was $154,589. The aggregate intrinsic value is calculated as the difference between the exercise prices of the underlying options and the quoted closing price of the common stock of the Company at the end of the reporting period for those options that have an exercise price below the quoted closing price. Warrants: The following table is the summary of warrant activities: Shares Underlying Warrants Weighted Weighted Average Remaining Contractual Life Outstanding at December 31, 2019 341,328 $ 6.24 1.42 Exercised (91,500 ) $ 4.50 - Expired (66,680 ) $ 12.13 - Outstanding at December 31, 2020 183,148 $ 4.96 1.61 On December 31, 2018, the Company sold to Elliott a senior secured convertible note in the aggregate principal amount of $7,500,000 and a warrant to purchase up to an aggregate of 90,000 shares of common stock, for gross proceeds of $7,500,000. The warrant is immediately exercisable, has an exercise price of $7.50 per share, subject to adjustment in the event of stock dividends and distributions, stock splits, stock combinations, or reclassifications affecting the Company’s common stock, and has a term of five years (see Note 6). On December 31, 2018, the Company amended and restated the following warrants held by Elliott and its affiliates to reduce the exercise price of each warrant to $0.001 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 (the “May 30, 2019 Warrants”); and warrants issued in October 2013 to purchase up to an aggregate of 150,000 shares of 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”). The incremental cost of approximately $710,000 associated with the warrant modification was recorded as a debt discount. 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 fair value of the warrant was determined using a Black-Scholes option pricing model using the following assumptions at the grant date of the warrant: Expected Term 5.0 years Volatility 102.85% Dividend yield 0.0% Exercise Price $1.50 Risk-free interest rate 2.51% 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 consolidated statement of operations and comprehensive loss for the year ended December 31, 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 December 31, 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 canceled in connection with the Exchange Agreement transaction (see Note 6). The warrant had an exercise price of $0.005. The incremental value of the warrant extended was immaterial. During the year ended December 31, 2020, the Company issued an aggregate of 91,500 shares of its common stock upon exercise of warrants, resulting in net proceeds of approximately $412,000. Stock-based Deferred Compensation Plan for Non-Employee Directors In 2014, the Company established an unfunded stock-based deferred compensation plan, providing non-employee directors the opportunity to defer up to one hundred percent of fees and compensation, including restricted stock units. The amount of fees and compensation deferred by a non-employee director is converted into stock units, the number of which is determined based on the closing price of the Company’s common stock on the date such compensation would have otherwise been payable. At all times, the plan participants are one hundred percent vested in their respective deferred compensation accounts. On the tenth business day of January in the year following a director’s termination of service, the director will receive a number of common shares equal to the number of stock units accumulated in the director’s deferred compensation account. The Company accounts for this plan as stock-based compensation under ASC 718. During the year ended December 31, 2020 and 2019, the amount of compensation that was deferred under this plan was $62,250 and $36,500, respectively. |
Concentrations
Concentrations | 12 Months Ended |
Dec. 31, 2020 | |
Risks and Uncertainties [Abstract] | |
Concentrations | Note 9 — Concentrations: At December 31, 2020 and 2019, one customer exceeded 10% of the Company’s accounts receivable (95%) and at December 31, 2019, no customer exceeded 10% of the Company’s accounts receivable. During the year ended December 31, 2020, the Company had revenue from two customers that exceeded 10% of its total sales (58% and 12%) and the Company had revenue from four customers that exceeded 10% of its total sales (42%, 18%, 17% and 12%) for the year ended December 31, 2019. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2020 | |
Leases [Abstract] | |
Leases | Note 10 — Leases: The Company entered into a seven-year operating lease agreement in March 2020 for an office space at 300 Connell Drive, Berkeley Heights, New Jersey 07922. The lease agreement, with a monthly average cost of approximately $17,000 commenced on September 16, 2020. The Company’s sublease on its previous premises at 400 Connell Drive, Berkeley Heights, New Jersey 07922 terminated on November 30, 2020. 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. Operating lease expense in the Company’s consolidated statements of operations and comprehensive loss for the year ended December 31, 2020 and 2019 was approximately $66,000 and $6,000, respectively, which includes costs associated with leases for which ROU assets have been recognized as well as short-term leases. At December 31, 2020 and 2019, the Company has a total operating lease liability of $1,033,000 and $4,000, respectively. At December 31, 2020, approximately $109,000 and $924,000 were classified as operating lease liabilities, short-term and operating lease liabilities, net of current portion, respectively, on the consolidated balance sheet. At December 31, 2019, approximately $2,000 was included in each operating lease liabilities, short-term and operating lease liabilities, net of current portion on the consolidated balance sheet. Operating ROU assets as of December 31, 2020 and 2019 are $1,015,000 and $5,000, respectively. For the year ended December 31, 2020 and 2019, cash paid for amounts included in the measurement of lease liabilities in operating cash flows from operating leases was $48,000 and $6,000, respectively. As of December 31, 2020 and 2019, the weighted average remaining lease term were 6.8 years and 2.8 years, respectively and the weighted average discount rate of 9% and 10% at December 31, 2020 and 2019, respectively. As of December 31, 2020, maturities of lease liabilities were as follows: 2021 $ 198,000 2022 200,000 2023 202,000 2024 205,000 2025 208,000 2026 and thereafter 380,000 Total future minimum lease payments 1,393,000 Less imputed interest (360,000 ) Total $ 1,033,000 |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 11 — Subsequent Events: On February 5, 2021, the Company allocated to its ATM program an additional $25.0 million of the remaining $75.0 million available under its shelf registration statement. Giving effect to the additional $25.0 million, plus the $17.8 million available at December 31, 2020, the Company had a total of $42.8 million available under the ATM program. During January and February 2021, the Company sold an aggregate of 3,737,862 shares of its common stock under the ATM program and realized net proceeds of approximately $41.5 million. As of the filing of this Annual Report on Form 10-K, the Company has no available balance under its ATM program and it has $50.0 million available under its current shelf registration for the issuance of equity, debt or equity-linked securities. During the first quarter of 2021, the Company issued an aggregate of 92,167 shares of its common stock upon cashless exercise of 95,286 warrants and cash exercise of 21,898 warrants, resulting in net proceeds of $115,000. During the first quarter of 2021, the Company issued an aggregate of 656,069 shares of its common stock upon conversion of 10,001 Series G preferred shares by Elliott and 50,000 Series C-3 preferred shares by an unrelated party. As previously announced, the NJEDA has approved the Company’s application to participate in the NJEDA Program for the state fiscal year 2020. The approval will allow the Company to sell approximately $1.3 million of the total $1.3 million in available tax benefits to an unrelated, profitable New Jersey corporation in return for approximately $1.3 million in cash. Closing is subject to NJEDA’s typical closing conditions, which are in process of completion. |
Accounting Policies, by Policy
Accounting Policies, by Policy (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America 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 consolidated financial statements include the accounts of the Company, CorMedix Europe GmbH and CorMedix Spain, S.L.U. its wholly owned subsidiaries. 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 following table is the reconciliation of the accounting standard that modifies certain aspects of the recognition, measurement, presentation and disclosure of financial instruments as shown on the Company’s consolidated statement of cash flows: December 31, 2020 2019 Cash and cash equivalents $ 41,905,469 $ 16,350,237 Restricted cash 191,314 174,950 Total cash, cash equivalents and restricted cash $ 42,096,783 $ 16,525,187 The appropriate classification of marketable securities is determined at the time of purchase and reevaluated as of each balance sheet date. Investments in marketable debt and equity securities classified as available-for-sale are reported at fair value. Fair value is determined using quoted market prices in active markets for identical assets or liabilities or quoted prices for similar assets or liabilities or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Changes in fair value that are considered temporary are reported net of tax in other comprehensive income (loss). Realized gains and losses, amortization of premiums and discounts and interest and dividends earned are included in income (expense). For declines in the fair value of equity securities that are considered other-than-temporary, impairment losses are charged to other (income) expense, net. The Company considers available evidence in evaluating potential impairments of its investments, including the duration and extent to which fair value is less than cost. There were no deemed permanent impairments at December 31, 2020 or 2019. 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 December 31, 2020 and 2019, all of the Company’s investments had contractual maturities which were less than one year. The following table summarizes the amortized cost, unrealized gains and losses and the fair value at December 31, 2020 and 2019: Amortized Cost Gross Unrealized Losses Gross Unrealized Gains Fair Value December 31, 2020: Money Market Funds and Cash Equivalents $ 3,182,762 $ (81 ) $ 8 $ 3,182,689 Corporate Securities 3,565,501 (1,005 ) 3 3,564,499 Commercial Paper 879,501 - 72 879,573 Subtotal 4,445,002 (1,005 ) 75 4,444,072 Total December 31, 2020 $ 7,627,764 $ (1,086 ) $ 83 $ 7,626,761 December 31, 2019: Money Market Funds and Cash Equivalents $ 3,472,043 $ - $ 51 $ 3,472,094 U.S. Government Agency Securities 2,691,091 (42 ) 869 2,691,918 Corporate Securities 6,058,265 (1,438 ) 440 6,057,267 Commercial Paper 3,234,583 (16 ) 405 3,234,972 Subtotal 11,983,939 (1,496 ) 1,714 11,984,157 Total December 31, 2019 $ 15,455,982 $ (1,496 ) $ 1,765 $ 15,456,251 |
Fair Value Measurements | Fair Value Measurements The Company’s financial instruments recorded in the consolidated balance sheets include cash and cash equivalents, accounts receivable, investment securities, accounts payable and accrued expenses. The carrying value of certain financial instruments, primarily cash and cash equivalents, accounts receivable, accounts payable, and accrued expenses approximate their estimated fair values based upon the short-term nature of their maturity dates. The Company’s senior secured convertible note (prior to its extinguishment in August 2019) falls into the Level 3 category within the fair value level hierarchy. The fair value was determined using market data for valuation. 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, which is set out below. 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. ● 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 as of December 31, 2020 and 2019: Carrying Value Level 1 Level 2 Level 3 December 31, 2020: Money Market Funds and Cash Equivalents $ 3,182,689 $ 3,182,689 $ - $ - Corporate Securities 3,564,499 - 3,564,499 - Commercial Paper 879,573 - 879,573 - Subtotal 4,444,072 - 4,444,072 - Total December 31, 2020 $ 7,626,761 $ 3,182,689 $ 4,444,072 $ - December 31, 2019: Money Market Funds and Cash Equivalents $ 3,472,094 3,472,094 - - U.S. Government Agency Securities 2,691,918 2,691,918 - - Corporate Securities 6,057,267 - 6,057,267 - Commercial Paper 3,234,972 - 3,234,972 - Subtotal 11,984,157 2,691,918 9,292,239 - Total December 31, 2019 $ 15,456,251 $ 6,164,012 $ 9,292,239 $ - |
Foreign Currency Translation and Transactions | Foreign Currency Translation and Transactions The 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 subsidiaries, whose functional currency is the EURO, foreign currency asset and liability amounts, if any, 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 year. Translation gains and losses are included in other comprehensive income (loss). The Company had a foreign currency translation gain of $6,020 in 2020 and a gain of $467 in 2019. 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. |
Geographic Information | Geographic Information The following table summarizes the geographic information: December 31, 2020 2019 Reported revenues $ 239,231 $ 283,266 Revenues attributable to European and Mideast operations, which are based in Germany 237,025 274,443 Total assets 49,308,303 29,475,910 Total assets located in the United States, with the remainder in the European Union $ 48,928,244 $ 28,919,276 |
Restricted Cash | Restricted Cash As of December 31, 2020, and 2019 the Company has restricted cash in connection with the patent and utility model infringement proceedings against TauroPharm (see Note 7). The Company was required by the District Court Mannheim to provide a security deposit of approximately $135,000 (€110,000) to cover legal fees in the event TauroPharm is entitled to reimbursement of these costs. The Company furthermore had to provide a deposit in the amount of $44,000 (€36,000) and $12,000 (€10,000) for the first and second instances, respectively, in connection with the unfair competition proceedings in Cologne. During the year ended December 31, 2020, the Company reimbursed TauroPharm approximately $30,000 for the costs in connection with the utility model infringement proceedings. In January 2021, approximately $48,000 (€40,000) was released by the court to the Company’s account which will be deducted from the restricted cash. |
Prepaid Research and Development and Other Prepaid Expenses | 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, pre-clinical 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 DefenCath product. Inventories consist of the following: December 31, 2020 2019 Raw materials $ - $ 6,893 Finished goods 317,733 461,735 Inventory reserve (174,169 ) (130,163 ) Total $ 143,564 $ 338,465 |
Property and Equipment | Property and Equipment Property and equipment consist primarily of furnishings, fixtures, leasehold improvements, office equipment and computer equipment all of which are recorded at cost. Depreciation is provided for by the straight-line method over the estimated useful lives of the related assets. Leasehold improvements are amortized using the straight-line method over the remaining lease term or the life of the asset, whichever is shorter. Property and equipment, as of December 31, 2020 and 2019 were $111,499 and $122,130, respectively, net of accumulated depreciation of $303,279 and $244,328, respectively. Depreciation and amortization of property and equipment is included in selling, general and administrative expenses. Description Estimated Useful Life Office equipment and furniture 5 years Leasehold improvements 7 years Computer equipment 5 years Computer software 3 years |
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 (included in accrued expenses), and operating lease liabilities, net of current portion, on the consolidated balance sheet (see Note 10). 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: December 31, 2020 2019 Professional and consulting fees $ 146,129 $ 214,777 Accrued payroll and payroll taxes 2,490,441 1,287,047 Clinical trial related 2,187 2,435,953 Manufacturing development related 143,780 806,032 Other 141,814 54,666 Total $ 2,924,351 $ 4,798,475 |
Revenue Recognition | Revenue Recognition The Company uses Accounting Standards Codification (“ASC”) 606, “ Revenue from Contracts with Customers,” The Company recognizes net sales upon shipment of product to the dialysis centers 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 South Korea. Upon execution, 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 South Korea (the “Territory”). The term of the Wonik Agreement commenced on August 8, 2014 and will continue for three years after the first commercial sale of Neutrolin in the Territory. The non-refundable up-front payment has been recorded as deferred revenue and will be recognized as revenue on a straight-line basis over the contractual term of the Agreement. Deferred revenue related to this agreement was fully amortized at December 31, 2020. |
Loss Per Common Share | Loss Per Common Share Basic loss per common share excludes dilution and is computed by dividing net loss by the weighted average number of common shares outstanding during the period. Diluted 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. The Company’s outstanding shares of Series E preferred stock entitle the holders to receive dividends on a basis equivalent to the dividends paid to holders of common stock. As a result, the Series E preferred stock meet the definition of participating securities requiring the application of the two-class method. Under the two-class method, earnings available to common shareholders, including both distributed and undistributed earnings, are allocated to each class of common stock and participating securities according to dividends declared and participating rights in undistributed earnings, which may cause diluted earnings per share to be more dilutive than the calculation using the treasury stock method. No loss has been allocated to these participating securities since they do not have contractual obligations that require participation in the Company’s losses. Since the Company has only incurred losses, basic and diluted loss per share are the same as potentially dilutive shares have been excluded from the calculation of diluted net loss per share as their effect would be anti-dilutive. The shares outstanding at the end of the respective periods presented below were excluded from the calculation of diluted net loss per share due to their anti-dilutive effect: Number of Shares of Common Stock Issuable At December 31, 2020 2019 Series C non-voting preferred stock 104,000 104,000 Series E voting preferred stock 391,953 391,953 Series G voting preferred stock 5,560,137 5,560,137 Restricted stock units - 2,490 Shares issuable for payment of deferred board compensation 48,909 33,597 Shares underlying outstanding warrants 183,148 341,328 Shares underlying outstanding stock options 2,447,687 1,376,394 Total potentially dilutive shares 8,735,834 7,809,899 |
Stock-Based Compensation | Stock-Based Compensation Share-based compensation cost is measured at grant date, based on the estimated fair value of the award using the Black-Scholes option pricing model for options with service or performance-based conditions. Stock-based compensation is recognized as expense over the requisite service period on a straight-line basis or when the achievement of the performance condition is probable. |
Research and Development | Research and Development Research and development costs are charged to expense as incurred. Research and development include fees associated with operational consultants, contract clinical research organizations, contract manufacturing organizations, clinical site fees, contract laboratory research organizations, contract central testing laboratories, licensing activities, and allocated executive, human resources and facilities expenses. The Company accrues for costs incurred as the services are being provided by monitoring the status of the trial and the invoices received from its external service providers. As actual costs become known, the Company adjusts its accruals in the period when actual costs become known. Costs related to the acquisition of technology rights and patents for which development work is still in process are charged to operations as incurred and considered a component of research and development expense. |
Income Taxes | Income Taxes Deferred tax assets and liabilities are recognized for the future tax consequences attributable to temporary differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Valuation allowances are established when it is more likely than not that some or all of the deferred tax assets will not be realized. |
Recently Adopted Authoritative Pronouncements | Recently Adopted Authoritative Pronouncements In June 2016, the Financial Accounting Standards Board (“FASB”) issued new guidance which replaces the incurred loss impairment methodology in current GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. This adoption on January 1, 2020 did not have a material impact on the Company’s consolidated financial statements. In August 2018, the FASB issued new guidance which modifies the disclosure requirements on fair value measurements. The guidance was effective for the Company beginning in the first quarter of fiscal year 2020. This adoption on January 1, 2020 did not have a material impact on the Company’s consolidated financial statements. In November 2018, the FASB issued new guidance to clarify the interaction between the authoritative guidance for collaborative arrangements and revenue from contracts with customers. The new guidance clarifies that, when the collaborative arrangement participant is a customer in the context of a unit-of-account, revenue from contracts with customers guidance should be applied, adds unit-of-account guidance to collaborative arrangements guidance, and, in a transaction with a collaborative arrangement participant who is not a customer, precludes presenting the transaction together with revenue recognized under contracts with customers. The guidance was effective for the Company beginning in the first quarter of fiscal year 2020. This adoption on January 1, 2020 did not have a material impact on the Company’s consolidated financial statements. In November 2019, the FASB issued new guidance which requires that an entity measure and classify share-based payment awards granted to a customer by applying the guidance in FASB ASC 718. The guidance was effective for the Company beginning in the first quarter of fiscal year 2020. This adoption on January 1, 2020 did not have a material impact on the Company’s consolidated financial statements. |
Recent Authoritative Pronouncements | Recent Authoritative Pronouncements In December 2019, the FASB issued new guidance which removes certain exceptions to the general principles of the accounting for income taxes and also improves consistent application of and simplification of other areas when accounting for income taxes. The guidance is effective for the company beginning in the first quarter of fiscal year 2021. Early adoption is permitted. The Company is assessing the impact of adopting this guidance on its consolidated financial statements. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Schedule of cash and cash equivalents | December 31, 2020 2019 Cash and cash equivalents $ 41,905,469 $ 16,350,237 Restricted cash 191,314 174,950 Total cash, cash equivalents and restricted cash $ 42,096,783 $ 16,525,187 |
Schedule of marketable securities | Amortized Cost Gross Unrealized Losses Gross Unrealized Gains Fair Value December 31, 2020: Money Market Funds and Cash Equivalents $ 3,182,762 $ (81 ) $ 8 $ 3,182,689 Corporate Securities 3,565,501 (1,005 ) 3 3,564,499 Commercial Paper 879,501 - 72 879,573 Subtotal 4,445,002 (1,005 ) 75 4,444,072 Total December 31, 2020 $ 7,627,764 $ (1,086 ) $ 83 $ 7,626,761 December 31, 2019: Money Market Funds and Cash Equivalents $ 3,472,043 $ - $ 51 $ 3,472,094 U.S. Government Agency Securities 2,691,091 (42 ) 869 2,691,918 Corporate Securities 6,058,265 (1,438 ) 440 6,057,267 Commercial Paper 3,234,583 (16 ) 405 3,234,972 Subtotal 11,983,939 (1,496 ) 1,714 11,984,157 Total December 31, 2019 $ 15,455,982 $ (1,496 ) $ 1,765 $ 15,456,251 |
Schedule of carrying and fair value of financial assets | Carrying Value Level 1 Level 2 Level 3 December 31, 2020: Money Market Funds and Cash Equivalents $ 3,182,689 $ 3,182,689 $ - $ - Corporate Securities 3,564,499 - 3,564,499 - Commercial Paper 879,573 - 879,573 - Subtotal 4,444,072 - 4,444,072 - Total December 31, 2020 $ 7,626,761 $ 3,182,689 $ 4,444,072 $ - December 31, 2019: Money Market Funds and Cash Equivalents $ 3,472,094 3,472,094 - - U.S. Government Agency Securities 2,691,918 2,691,918 - - Corporate Securities 6,057,267 - 6,057,267 - Commercial Paper 3,234,972 - 3,234,972 - Subtotal 11,984,157 2,691,918 9,292,239 - Total December 31, 2019 $ 15,456,251 $ 6,164,012 $ 9,292,239 $ - |
Schedule of segment and geographic information | December 31, 2020 2019 Reported revenues $ 239,231 $ 283,266 Revenues attributable to European and Mideast operations, which are based in Germany 237,025 274,443 Total assets 49,308,303 29,475,910 Total assets located in the United States, with the remainder in the European Union $ 48,928,244 $ 28,919,276 |
Schedule of inventories | December 31, 2020 2019 Raw materials $ - $ 6,893 Finished goods 317,733 461,735 Inventory reserve (174,169 ) (130,163 ) Total $ 143,564 $ 338,465 |
Schedule of property and equipment | Description Estimated Useful Life Office equipment and furniture 5 years Leasehold improvements 7 years Computer equipment 5 years Computer software 3 years |
Schedule of accrued expenses | December 31, 2020 2019 Professional and consulting fees $ 146,129 $ 214,777 Accrued payroll and payroll taxes 2,490,441 1,287,047 Clinical trial related 2,187 2,435,953 Manufacturing development related 143,780 806,032 Other 141,814 54,666 Total $ 2,924,351 $ 4,798,475 |
Schedule of anti-dilutive securities excluded from calculation of diluted net loss per share | Number of Shares of Common Stock Issuable At December 31, 2020 2019 Series C non-voting preferred stock 104,000 104,000 Series E voting preferred stock 391,953 391,953 Series G voting preferred stock 5,560,137 5,560,137 Restricted stock units - 2,490 Shares issuable for payment of deferred board compensation 48,909 33,597 Shares underlying outstanding warrants 183,148 341,328 Shares underlying outstanding stock options 2,447,687 1,376,394 Total potentially dilutive shares 8,735,834 7,809,899 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Schedule of foreign loss before income taxes | December 31, 2020 2019 United States $ (20,605,821 ) $ (20,943,703 ) Foreign (591,257 ) (550,149 ) Total $ (27,197,078 ) $ (21,493,852 ) |
Schedule of deferred tax assets | December 31, 2020 2019 Net operating loss carryforwards – Federal $ 38,986,000 $ 33,494,000 Net operating loss carryforwards – State 2,958,000 6,171,000 Net operating loss carryforwards – Foreign 2,455,000 2,128,000 Capitalized licensing fees 600,000 757,000 Stock-based compensation 3,358,000 2,892,000 Accrued compensation 102,000 349,000 Other 21,000 24,000 Totals 48,480,000 45,815,000 Less valuation allowance (48,480,000 ) (45,815,000 ) Deferred tax assets $ - $ - |
Schedule of potentially utilizable net operating loss tax carryforwards | December 31, 2020 2019 Federal $ 185,650,000 $ 155,400,000 State $ 41,600,000 $ 82,700,000 Foreign $ 8,185,000 $ 7,091,000 |
Schedule of company’s effective tax rate varied from the statutory rate | December 31, 2020 2019 Statutory federal tax rate 21.0 % 21.0 % State income tax rate (net of federal) 4.3 % 7.2 % Effect of foreign operations 0.7 % 0.8 % Federal deferred tax rate change 0.5 % 0.1 % NJ NOL adjustment 2.9 % 6.2 % Other permanent differences (0.6 )% (0.4 )% Effect of valuation allowance (9.8 )% (11.3 )% Effective tax rate 19.0 % 23.6 % |
Schedule of the changes in the deferred tax asset valuation allowance | Year Ended Balance at Beginning of Year Increase (Decrease) Charged (Credited) to Income Taxes (Benefit) Increase (Decrease) Charged (Credited) to OCI Balance at End of Year December 31, 2020 $ 45,815,000 $ 2,696,000 $ (31,000 ) $ 48,480,000 December 31, 2019 $ 43,396,000 $ 2,449,000 $ (30,000 ) $ 45,815,000 |
Senior Secured Convertible No_2
Senior Secured Convertible Note, Related Party: (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Debt Disclosure [Abstract] | |
Schedule of assumptions used in the black scholes pricing model | Conversion Option New Warrants Expected term (months) 36 60 Volatility 161.5% 161.5% Dividend yield 0% 0% Risk-free interest rate 2.43% 2.48% |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Stockholders' Equity (Tables) [Line Items] | |
Schedule of preferred stock | As of December 31, 2020 As of December 31, 2019 Preferred Shares Outstanding Liquidation Preference Total Liquidation Preference Preferred Shares Outstanding Liquidation Preference Total Liquidation Preference Series C-3 52,000 $ 10.00 $ 520,000 52,000 $ 10.00 $ 520,000 Series E 89,623 $ 49.20 $ 4,409,452 89,623 $ 49.20 $ 4,409,452 Series G 100,000 $ 187.36 $ 18,736,452 100,000 $ 187.36 $ 18,736,452 Total 241,623 $ 23,665,904 241,623 $ 23,665,904 |
Schedule of fair value assumptions for black sholes | Expected term, years 3.0 Volatility 93.3 % Dividend yield 0.0 % Risk-free interest rate 1.53 % |
Stock Options [Member] | |
Stockholders' Equity (Tables) [Line Items] | |
Schedule of fair value assumptions for black sholes | Year Ended December 31, 2020 2019 Risk-free interest rate 0.27% - 1.67% 1.51% - 2.74% Expected volatility 102.7% - 107.9% 103% - 110% Expected term (years) 5 – 10 years 5-10 years Expected dividend yield 0.0% 0.0% Weighted-average grant date fair value of options granted during the period $3.59 $6.11 |
Schedule of option activity under plan and related information | Shares Underlying Stock Options Weighted- Weighted- Aggregate Intrinsic Value Outstanding at beginning of year 1,376,394 $ 8.98 6.8 $ 1,232,545 Granted 1,111,984 $ 5.11 2,585,172 Expired/Canceled (6,891 ) $ 12.53 - Forfeited (33,800 ) $ 8.51 9,000 Outstanding at end of year 2,447,687 $ 7.22 7.1 $ 3,872,092 Vested at end of year 1,418,990 $ 8.56 5.6 $ 1,683,965 Expected to vest in the future 1,028,697 $ 5.36 9.1 $ 2,188,127 |
Warrants [Member] | |
Stockholders' Equity (Tables) [Line Items] | |
Schedule of fair value assumptions for black sholes | Expected Term 5.0 years Volatility 102.85% Dividend yield 0.0% Exercise Price $1.50 Risk-free interest rate 2.51% Expected term 2.88 years Volatility 111.5% Dividend yield 0.0% Risk-free interest rate 1.62% |
Schedule of option activity under plan and related information | Shares Underlying Warrants Weighted Weighted Average Remaining Contractual Life Outstanding at December 31, 2019 341,328 $ 6.24 1.42 Exercised (91,500 ) $ 4.50 - Expired (66,680 ) $ 12.13 - Outstanding at December 31, 2020 183,148 $ 4.96 1.61 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Leases [Abstract] | |
Schedule of maturities of lease liabilities | 2021 $ 198,000 2022 200,000 2023 202,000 2024 205,000 2025 208,000 2026 and thereafter 380,000 Total future minimum lease payments 1,393,000 Less imputed interest (360,000 ) Total $ 1,033,000 |
Organization, Business and Ba_2
Organization, Business and Basis of Presentation (Details) | 1 Months Ended | 12 Months Ended |
Mar. 26, 2019 | Dec. 31, 2020 | |
Accounting Policies [Abstract] | ||
Organization and business, description | The Company has in-licensed the worldwide rights to develop and commercialize DefenCath/Neutrolin®, which is a novel anti-infective solution (a formulation of taurolidine 1.35% and heparin 1000 u/ml) intended for the reduction and prevention of catheter-related infections and thrombosis in patients requiring central venous catheters in clinical settings such as hemodialysis, total parenteral nutrition, and oncology. The name DefenCath is the U.S. proprietary name conditionally approved by the U.S. Food and Drug Administration (“FDA”), while the name Neutrolin is currently used in the European Union (“EU”) and other territories where the Company has received CE-Mark approval for the commercial distribution of Neutrolin as a catheter lock solution (“CLS”) regulated as a medical device. | |
Defencath relative to the active control, description | As previously agreed with the FDA, an interim efficacy analysis was performed when the first 28 potential CRBSI cases were identified in our LOCK-IT-100 study that occurred through early December 2017. Based on these first 28 cases, there was a highly statistically significant 72% reduction in CRBSI by DefenCath relative to the active control of heparin (p=0.0034). Because the pre-specified level of statistical significance was reached for the primary endpoint and efficacy had been demonstrated with no safety concerns, the LOCK-IT-100 study was terminated early. The study continued enrolling and treating subjects until study termination, and the final analysis was based on a total of 795 subjects. In a total of 41 cases, there was a 71% reduction in CRBSI by DefenCath relative to heparin, which was highly statistically significant (p=0.0006), with a good safety profile. | |
Pediatric research equity act, description | Pediatric studies for an approved product conducted under PREA may qualify for pediatric exclusivity, which if granted would provide an additional six months of marketing exclusivity. DefenCath would then have the potential to receive a total marketing exclusivity period of 10.5 years, including exclusivity pursuant to NCE and QIDP. | |
Reverse stock split, description | 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 our 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 our common stock (which remains at $0.001 per share) or the total number of shares of common stock that are authorized to be issued pursuant to our Amended and Restated Certificate of Incorporation, as amended, which remains at 160 million shares. |
Liquidity and Uncertainties (De
Liquidity and Uncertainties (Details) - USD ($) $ in Millions | 3 Months Ended | 12 Months Ended | |
Mar. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Liquidity and Uncertainties (Details) [Line Items] | |||
Accumulated deficit | $ 217.4 | ||
Net losses | $ 22 | $ 16.4 | |
Subsequent Event [Member] | |||
Liquidity and Uncertainties (Details) [Line Items] | |||
Net proceeds | $ 41.5 | ||
New ATM agreement, description | As of the filing date of this Annual Report on Form 10-K, the Company has no available balance under its ATM program and has $50.0 million available under its current shelf registration for the issuance of equity, debt or equity-linked securities (see Note 8). |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) | Aug. 14, 2014USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Jan. 31, 2021USD ($) | Jan. 31, 2021EUR (€) | Dec. 31, 2020EUR (€) |
Summary of Significant Accounting Policies (Details) [Line Items] | ||||||
Foreign currency translation gain | $ 6,020 | $ 467 | ||||
Security deposit | 135,000 | € 110,000 | ||||
Cash reimbursed | 30,000 | |||||
Property and equipment, net | 111,499 | 122,130 | ||||
Accumulated depreciation | $ 303,279 | $ 244,328 | ||||
Short-term leases term, description | 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. | |||||
Deferred revenue non-refundable payment | $ 50,000 | |||||
Deferred revenue, additions upon receipt of the product registration | $ 50,000 | |||||
Subsequent Event [Member] | ||||||
Summary of Significant Accounting Policies (Details) [Line Items] | ||||||
Restricted cash | $ 48,000 | € 40,000 | ||||
First Instances [Member] | ||||||
Summary of Significant Accounting Policies (Details) [Line Items] | ||||||
Deposits | $ 44,000 | 36,000 | ||||
Second Instances [Member] | ||||||
Summary of Significant Accounting Policies (Details) [Line Items] | ||||||
Deposits | $ 12,000 | € 10,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) - Schedule of cash and cash equivalents - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Schedule of cash and cash equivalents [Abstract] | |||
Cash and cash equivalents | $ 41,905,469 | $ 16,350,237 | |
Restricted cash | 191,314 | 174,950 | |
Total cash, cash equivalents and restricted cash | $ 42,096,783 | $ 16,525,187 | $ 17,795,323 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies (Details) - Schedule of marketable securities - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Marketable Securities [Line Items] | ||
Amortized Cost | $ 7,627,764 | $ 15,455,982 |
Gross Unrealized Losses | (1,086) | (1,496) |
Gross Unrealized Gains | 83 | 1,765 |
Fair Value | 7,626,761 | 15,456,251 |
Money Market Funds and Cash Equivalents[Member] | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 3,182,762 | 3,472,043 |
Gross Unrealized Losses | (81) | |
Gross Unrealized Gains | 8 | 51 |
Fair Value | 3,182,689 | 3,472,094 |
Corporate Securities [Member] | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 3,565,501 | 6,058,265 |
Gross Unrealized Losses | (1,005) | (1,438) |
Gross Unrealized Gains | 3 | 440 |
Fair Value | 3,564,499 | 6,057,267 |
Commercial Paper [Member] | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 879,501 | 3,234,583 |
Gross Unrealized Losses | (16) | |
Gross Unrealized Gains | 72 | 405 |
Fair Value | 879,573 | 3,234,972 |
Subtotal [Member] | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 4,445,002 | 11,983,939 |
Gross Unrealized Losses | (1,005) | (1,496) |
Gross Unrealized Gains | 75 | 1,714 |
Fair Value | $ 4,444,072 | 11,984,157 |
U.S. Government Agency Securities [Member] | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 2,691,091 | |
Gross Unrealized Losses | (42) | |
Gross Unrealized Gains | 869 | |
Fair Value | $ 2,691,918 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | $ 7,626,761 | $ 15,456,251 |
Money Market Funds and Cash Equivalents [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | 3,182,689 | 3,472,094 |
Corporate Securities [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | 3,564,499 | 6,057,267 |
Commercial Paper [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | 879,573 | 3,234,972 |
Subtotal [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | 4,444,072 | 11,984,157 |
U.S. Government Agency Securities [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | 2,691,918 | |
Level 1 [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | 3,182,689 | 6,164,012 |
Level 1 [Member] | Money Market Funds and Cash Equivalents [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | 3,182,689 | 3,472,094 |
Level 1 [Member] | Corporate Securities [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | ||
Level 1 [Member] | Commercial Paper [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | ||
Level 1 [Member] | Subtotal [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | 2,691,918 | |
Level 1 [Member] | U.S. Government Agency Securities [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | 2,691,918 | |
Level 2 [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | 4,444,072 | 9,292,239 |
Level 2 [Member] | Money Market Funds and Cash Equivalents [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | ||
Level 2 [Member] | Corporate Securities [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | 3,564,499 | 6,057,267 |
Level 2 [Member] | Commercial Paper [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | 879,573 | 3,234,972 |
Level 2 [Member] | Subtotal [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | 4,444,072 | 9,292,239 |
Level 2 [Member] | U.S. Government Agency Securities [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | ||
Level 3 [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | ||
Level 3 [Member] | Money Market Funds and Cash Equivalents [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | ||
Level 3 [Member] | Corporate Securities [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | ||
Level 3 [Member] | Commercial Paper [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | ||
Level 3 [Member] | Subtotal [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value | ||
Level 3 [Member] | U.S. Government Agency Securities [Member] | ||
Summary of Significant Accounting Policies (Details) - Schedule of carrying and fair value of financial assets [Line Items] | ||
Carrying Value |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies (Details) - Schedule of segment and geographic information - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Segment Reporting Information [Line Items] | ||
Reported revenues | $ 239,231 | $ 283,266 |
Total assets | 49,308,303 | 29,475,910 |
European and Mideast operations [Member] | ||
Segment Reporting Information [Line Items] | ||
Reported revenues | 237,025 | 274,443 |
United States [Member] | ||
Segment Reporting Information [Line Items] | ||
Total assets | $ 48,928,244 | $ 28,919,276 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies (Details) - Schedule of inventories - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Schedule of inventories [Abstract] | ||
Raw materials | $ 6,893 | |
Finished goods | 317,733 | 461,735 |
Inventory reserve | (174,169) | (130,163) |
Total | $ 143,564 | $ 338,465 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies (Details) - Schedule of property and equipment | 12 Months Ended |
Dec. 31, 2020 | |
Office equipment and furniture [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life | 5 years |
Leasehold improvements [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life | 7 years |
Computer equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life | 5 years |
Computer software [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life | 3 years |
Summary of Significant Accou_10
Summary of Significant Accounting Policies (Details) - Schedule of accrued expenses - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Schedule of accrued expenses [Abstract] | ||
Professional and consulting fees | $ 146,129 | $ 214,777 |
Accrued payroll and payroll taxes | 2,490,441 | 1,287,047 |
Clinical trial related | 2,187 | 2,435,953 |
Manufacturing development related | 143,780 | 806,032 |
Other | 141,814 | 54,666 |
Total | $ 2,924,351 | $ 4,798,475 |
Summary of Significant Accou_11
Summary of Significant Accounting Policies (Details) - Schedule of anti-dilutive securities excluded from calculation of diluted net loss per share - shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive shares | 8,735,834 | 7,809,899 |
Series C non-voting preferred stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive shares | 104,000 | 104,000 |
Series E voting preferred stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive shares | 391,953 | 391,953 |
Series G voting preferred stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive shares | 5,560,137 | 5,560,137 |
Restricted stock units [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive shares | 2,490 | |
Shares issuable for payment of deferred board compensation [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive shares | 48,909 | 33,597 |
Shares underlying outstanding warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive shares | 183,148 | 341,328 |
Shares underlying outstanding stock options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive shares | 2,447,687 | 1,376,394 |
Related Party Transactions_ (De
Related Party Transactions: (Details) - USD ($) | Aug. 14, 2019 | Dec. 31, 2018 | May 31, 2013 |
Related Party Transactions: (Details) [Line Items] | |||
Related party, description | the Company entered into an exchange agreement (the “Exchange Agreement”) with Manchester Securities Corp. (“Manchester”), an existing institutional investor and 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 Notes 6 and 8). | ||
Warrant [Member] | |||
Related Party Transactions: (Details) [Line Items] | |||
Warrant issued | 100,000 | ||
Senior secured convertible note [Member] | |||
Related Party Transactions: (Details) [Line Items] | |||
Percentage of sale of senior secured convertible note | 10.00% | ||
Aggregate principal amount | $ 7,500,000 | ||
Aggregate shares amount | 90,000 | ||
Gross proceeds of common stock | $ 7,500,000 | ||
Description of sale of stock | The warrant with a grant date fair value of $433,365, is immediately exercisable, has an exercise price of $7.50 per share, subject to adjustment in the event of stock dividends and distributions, stock splits, stock combinations, or reclassifications affecting our common stock, and has a term of five years. The note has a conversion price of $7.50 per share. | 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. | |
Grant date of fair value | $ 433,365 | ||
Conversion price | $ 7.50 | ||
Exercise price | $ 0.005 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |||
Net operating loss deduction | 80.00% | ||
Tax benefit net | $ (5,169,395) | $ (5,060,778) | |
Sales allowed | 5,529,000 | $ 5,413,000 | |
Net operating loss tax benefits | $ 6,018,000 | $ 6,085,000 |
Income Taxes (Details) - Schedu
Income Taxes (Details) - Schedule of foreign loss before income taxes - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Income Taxes (Details) - Schedule of foreign loss before income taxes [Line Items] | ||
Loss before income taxes | $ (27,197,078) | $ (21,493,852) |
United States [Member] | ||
Income Taxes (Details) - Schedule of foreign loss before income taxes [Line Items] | ||
Loss before income taxes | (20,605,821) | (20,943,703) |
Foreign [Member] | ||
Income Taxes (Details) - Schedule of foreign loss before income taxes [Line Items] | ||
Loss before income taxes | $ (591,257) | $ (550,149) |
Income Taxes (Details) - Sche_2
Income Taxes (Details) - Schedule of deferred tax assets - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Schedule of deferred tax assets [Abstract] | ||
Net operating loss carryforwards – Federal | $ 38,986,000 | $ 33,494,000 |
Net operating loss carryforwards – State | 2,958,000 | 6,171,000 |
Net operating loss carryforwards – Foreign | 2,455,000 | 2,128,000 |
Capitalized licensing fees | 600,000 | 757,000 |
Stock-based compensation | 3,358,000 | 2,892,000 |
Accrued compensation | 102,000 | 349,000 |
Other | 21,000 | 24,000 |
Totals | 48,480,000 | 45,815,000 |
Less valuation allowance | (48,480,000) | (45,815,000) |
Deferred tax assets |
Income Taxes (Details) - Sche_3
Income Taxes (Details) - Schedule of potentially utilizable net operating loss tax carryforwards - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Federal [Member] | ||
Income Taxes (Details) - Schedule of potentially utilizable net operating loss tax carryforwards [Line Items] | ||
Potentially utilizable net operating loss carryforwards | $ 185,650,000 | $ 155,400,000 |
State [Member] | ||
Income Taxes (Details) - Schedule of potentially utilizable net operating loss tax carryforwards [Line Items] | ||
Potentially utilizable net operating loss carryforwards | 41,600,000 | 82,700,000 |
Foreign [Member] | ||
Income Taxes (Details) - Schedule of potentially utilizable net operating loss tax carryforwards [Line Items] | ||
Potentially utilizable net operating loss carryforwards | $ 8,185,000 | $ 7,091,000 |
Income Taxes (Details) - Sche_4
Income Taxes (Details) - Schedule of company’s effective tax rate varied from the statutory rate | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Schedule of company’s effective tax rate varied from the statutory rate [Abstract] | ||
Statutory federal tax rate | 21.00% | 21.00% |
State income tax rate (net of federal) | 4.30% | 7.20% |
Effect of foreign operations | 0.70% | 0.80% |
Federal deferred tax rate change | 0.50% | 0.10% |
NJ NOL adjustment | 2.90% | 6.20% |
Other permanent differences | (0.60%) | (0.40%) |
Effect of valuation allowance | (9.80%) | (11.30%) |
Effective tax rate | 19.00% | 23.60% |
Income Taxes (Details) - Sche_5
Income Taxes (Details) - Schedule of the changes in the deferred tax asset valuation allowance - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Schedule of the changes in the deferred tax asset valuation allowance [Abstract] | ||
Deferred tax asset valuation allowance, beginning | $ 45,815,000 | $ 43,396,000 |
Increase (Decrease) Charged (Credited) to Income Taxes (Benefit) | 2,696,000 | 2,449,000 |
Increase (Decrease) Charged (Credited) to OCI | (31,000) | (30,000) |
Deferred tax asset valuation allowance, ending | $ 48,480,000 | $ 45,815,000 |
Senior Secured Convertible No_3
Senior Secured Convertible Note, Related Party: (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Senior Secured Convertible Note, Related Party: (Details) [Line Items] | ||
Percentage of secured convertible note | 10.00% | |
Aggregate principal | $ 7,500,000 | |
Warrant purchase (in Shares) | 90,000 | 90,000 |
Gross proceeds | $ 7,500,000 | |
Interest expenses | $ 462,000 | |
Warrants issued, 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 | 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 16, 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”). |
Letters of credit incurred | $ 3,000,000 | |
Warrants of approximately | 396,000 | |
Additional paid-in capital | 6,000 | |
Net allocated fees | 103,000 | |
Incremental cost of approximately | 710,000 | |
Debt discount | $ 313,000 | |
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 consolidated statement of operations and comprehensive loss for the year ended December 31, 2019 (see Note 8). | |
Warrant [Member] | ||
Senior Secured Convertible Note, Related Party: (Details) [Line Items] | ||
Gross proceeds | 7,500,000 | |
Legal fees | 267,000 | |
Net allocated fees | 7,000,000 | |
Debt discount | $ 143,000 |
Senior Secured Convertible No_4
Senior Secured Convertible Note, Related Party: (Details) - Schedule of assumptions used in the black scholes pricing model | 12 Months Ended |
Dec. 31, 2020 | |
Conversion Option At Issuance Date [Member] | |
Senior Secured Convertible Note, Related Party: (Details) - Schedule of assumptions used in the black scholes pricing model [Line Items] | |
Expected term (months) | 36 months |
Volatility | 161.50% |
Dividend yield | 0.00% |
Risk-free interest rate | 2.43% |
New Warrants At Issuance Date [Member] | |
Senior Secured Convertible Note, Related Party: (Details) - Schedule of assumptions used in the black scholes pricing model [Line Items] | |
Expected term (months) | 60 months |
Volatility | 161.50% |
Dividend yield | 0.00% |
Risk-free interest rate | 2.48% |
Commitments and Contingencies (
Commitments and Contingencies (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Sep. 16, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2014 | |
Commitments and Contingencies Disclosure [Abstract] | ||||
Aggregate deposit amount | $ 191,000 | |||
Cash reimbursed | 30,000 | |||
Restricted cash | 48,000 | |||
Amount of initial licensing fee | $ 325,000 | |||
Percentage of equity interest | 5.00% | |||
Shares of equity of common stock (in Shares) | 7,996 | |||
Maximum aggregate number of shares issuable (in Shares) | 29,109 | |||
Number of shares released in escrow (in Shares) | 7,277 | |||
Number of share held In escrow of common stock (in Shares) | 21,832 | |||
Maximum aggregate amount of cash payments due | $ 3,000,000 | $ 2,500,000 | ||
Payments for leasing costs | $ 17,000 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) | Aug. 14, 2019 | Mar. 09, 2018 | Nov. 09, 2017 | Nov. 30, 2020 | Jul. 30, 2020 | Dec. 31, 2019 | Sep. 25, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Nov. 26, 2019 |
Stockholders' Equity (Details) [Line Items] | |||||||||||
Common stock, par value | $ 0.001 | $ 0.001 | $ 0.001 | ||||||||
Common stock proceeds (in Dollars) | $ 18,432,945 | $ 15,234,529 | |||||||||
Common stock, shares (in Shares) | 25,665,350 | 33,558,096 | 25,665,350 | ||||||||
Preferred stock, shares authorized (in Shares) | 2,000,000 | 2,000,000 | 2,000,000 | ||||||||
Preferred stock, par value | $ 0.001 | $ 0.001 | $ 0.001 | ||||||||
Secured convertible note percentage | 10.00% | ||||||||||
Cash payments (in Dollars) | $ 2,000,000 | ||||||||||
Convertible common stock (in Shares) | 5,560,138 | ||||||||||
Conversion price | $ 3.37 | ||||||||||
Senior secured convertible note percentage | 10.00% | ||||||||||
Deemed dividend (in Dollars) | $ 26,733,098 | ||||||||||
Exchange agreement, description | During the years ended December 31, 2020 and 2019, total compensation expense for stock options issued to employees, directors, officers and consultants was $2,489,000 and $2,242,000, respectively. | ||||||||||
Number of shares the Company may issue under the 2019 plan (in Shares) | 3,000,000 | ||||||||||
Maximum number of shares carry-forward (in Shares) | 522,606 | ||||||||||
Stock option (in Shares) | 496,300 | 1,111,984 | 496,300 | ||||||||
Weighted average exercise price | $ 8.98 | $ 7.22 | $ 8.98 | ||||||||
Unrecognized compensation expense (in Dollars) | $ 3,284,000 | ||||||||||
Weighted average remaining contractual life | 1 year 8 months 12 days | ||||||||||
Dividend yield | 0.00% | ||||||||||
Total intrinsic value (in Dollars) | $ 154,589 | ||||||||||
Warrants issued, 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 | 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 16, 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”). | |||||||||
Exercise price | $ 0.005 | ||||||||||
Common stock shares issued (in Shares) | 1,224,263 | ||||||||||
Net proceeds exercise of stock options (in Dollars) | $ 4,900,000 | ||||||||||
Incremental value (in Dollars) | $ 369,500 | ||||||||||
Deferred compensation (in Dollars) | $ 62,250 | $ 36,500 | |||||||||
Employees [Member] | |||||||||||
Stockholders' Equity (Details) [Line Items] | |||||||||||
Expected term (years) | 5 years | ||||||||||
Non-Employees [Member] | |||||||||||
Stockholders' Equity (Details) [Line Items] | |||||||||||
Expected term (years) | 10 years | ||||||||||
Maximum [Member] | |||||||||||
Stockholders' Equity (Details) [Line Items] | |||||||||||
Common stock percentage | 9.99% | ||||||||||
Expected term (years) | 10 years | 10 years | |||||||||
Exercise price | $ 5.25 | ||||||||||
Minimum [Member] | |||||||||||
Stockholders' Equity (Details) [Line Items] | |||||||||||
Expected term (years) | 5 years | 5 years | |||||||||
Exercise price | $ 4 | ||||||||||
Common Stock [Member] | |||||||||||
Stockholders' Equity (Details) [Line Items] | |||||||||||
New ATM agreement, description | The Company had a prior sales agreement with FBR Securities, Inc., (formerly known as B. Riley FBR, Inc.) (“B. Riley”) for its ATM program, which 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. On March 9, 2018, the Company entered into a new agreement with B. Riley for the sale of up to $14.7 million of the Company’s common stock under the ATM program, pursuant to a registration statement filed on March 9, 2018 for an aggregate of $70 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. The ATM program amount was increased by $25.0 million in November 2018. Under the ATM program, the Company may issue and sell common stock from time to time through B. Riley acting as agent, subject to limitations imposed by the Company and subject to B. Riley’s acceptance, such as the number or dollar amount of shares registered under the registration statement to which the offering relates. B. Riley is entitled to a commission of up to 3% of the gross proceeds from the sale of common stock sold under the ATM program. During the years ended December 31, 2020 and 2019, the Company sold 1,854,970 and 1,768,012 shares of common stock under the new and expired ATM programs, respectively, and realized net proceeds of approximately $11.4 million and $15.2 million during the years ended December 31, 2020 and 2019, respectively. At December 31, 2020, this current ATM program and the current shelf registration for the issuance of equity, debt or equity-linked securities has been exhausted. | the Company filed a new registration statement, under which the Company could issue and sell up to an aggregate of $100.0 million of shares of its common stock, $0.001 par value per share. On November 27, 2020, the Company entered into an Amended and Restated At Market Issuance Sales Agreement (“Amended Sales Agreement”) with B. Riley and Needham & Company, LLC (“Needham”), together with B. Riley, acting as sales agents (“Sales Agent”). The Amended Sales Agreement relates to the sale of shares of up to $25.0 million of the Company’s common stock under its ATM program, of which the Company may issue and sell common stock from time to time through the Sales Agent, subject to limitations imposed by the Company and subject to Sales Agent’s acceptance, such as the number or dollar amount of shares registered under the registration statement to which the offering relates. Sales Agent is entitled to a commission of up to 3% of the gross proceeds from the sale of common stock sold under the ATM program. During the year ended December 31, 2020, the Company sold 832,676 shares of common stock under the Amended Sales Agreement at the weighted average price of $8.69 per share and realized net proceeds of approximately $7.0 million. At December 31, 2020, the Company had approximately $17.8 million available under the Amended Sales Agreement and $75.0 million available under its current shelf registration for the issuance of equity, debt or equity-linked securities unrelated to the Amended Sales Agreement. | |||||||||
Warrants [Member] | |||||||||||
Stockholders' Equity (Details) [Line Items] | |||||||||||
Warrants issued, description | the Company sold to Elliott a senior secured convertible note in the aggregate principal amount of $7,500,000 and a warrant to purchase up to an aggregate of 90,000 shares of common stock, for gross proceeds of $7,500,000. The warrant is immediately exercisable, has an exercise price of $7.50 per share, subject to adjustment in the event of stock dividends and distributions, stock splits, stock combinations, or reclassifications affecting the Company’s common stock, and has a term of five years (see Note 6). On December 31, 2018, the Company amended and restated the following warrants held by Elliott and its affiliates to reduce the exercise price of each warrant to $0.001 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 (the “May 30, 2019 Warrants”); and warrants issued in October 2013 to purchase up to an aggregate of 150,000 shares of 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”). The incremental cost of approximately $710,000 associated with the warrant modification was recorded as a debt discount. 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. | ||||||||||
Warrant [Member] | |||||||||||
Stockholders' Equity (Details) [Line Items] | |||||||||||
Stock issued in connection with warrants exercised (in Shares) | 91,500 | ||||||||||
Value of stock issued in connection with upon exercise of warrants (in Dollars) | $ 412,000 | ||||||||||
Restricted Stock [Member] | |||||||||||
Stockholders' Equity (Details) [Line Items] | |||||||||||
Restricted stock units issued (in Shares) | 24,850 | ||||||||||
Weighted average grant date fair value | $ 8.33 | ||||||||||
Unrecognized compensation expense (in Dollars) | $ 198,000 | $ 11,000 | $ 198,000 | ||||||||
Issuance of vested restricted stock (in Shares) | 2,490 | 25,346 | |||||||||
Series F Stock [Member] | |||||||||||
Stockholders' Equity (Details) [Line Items] | |||||||||||
Sales proceeds (in Dollars) | $ 2,000,000 | ||||||||||
Stock per share | $ 1,000 | ||||||||||
2019 Plan [Member] | |||||||||||
Stockholders' Equity (Details) [Line Items] | |||||||||||
Weighted average exercise price | $ 5.11 | ||||||||||
2013 Plan [Member] | |||||||||||
Stockholders' Equity (Details) [Line Items] | |||||||||||
Weighted average exercise price | $ 7.64 | $ 7.64 | |||||||||
Underwriters [Member] | |||||||||||
Stockholders' Equity (Details) [Line Items] | |||||||||||
Common stock, shares (in Shares) | 5,111,110 | ||||||||||
Common Stock, Shares, Issued (in Shares) | 666,666 | ||||||||||
Common Stock [Member] | |||||||||||
Stockholders' Equity (Details) [Line Items] | |||||||||||
Common stock, par value | $ 0.001 | ||||||||||
Common stock proceeds (in Dollars) | $ 21,300,000 | ||||||||||
Sale of stock, price | $ 4.50 | ||||||||||
Secured convertible note percentage | 4.99% | ||||||||||
Common stock, per share price | $ 7.93 | ||||||||||
Series G Preferred Stock [Member] | |||||||||||
Stockholders' Equity (Details) [Line Items] | |||||||||||
Common stock proceeds (in Dollars) | $ 18,736,452 | ||||||||||
Sale of common stock (in Shares) | 100,000 | ||||||||||
Fair value percentage | 10.00% | ||||||||||
Series F Preferred Stock [Member] | |||||||||||
Stockholders' Equity (Details) [Line Items] | |||||||||||
Senior secured convertible note percentage | 10.00% | ||||||||||
Senior Secured Convertible Note [Member] | |||||||||||
Stockholders' Equity (Details) [Line Items] | |||||||||||
Exchange agreement, description | 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. | ||||||||||
Series C-3 Non-Voting Preferred Stock [Member] | |||||||||||
Stockholders' Equity (Details) [Line Items] | |||||||||||
Sale of common stock (in Shares) | 2 | ||||||||||
Series C-3 Preferred Stock [Member] | |||||||||||
Stockholders' Equity (Details) [Line Items] | |||||||||||
Preferred stock, par value | $ 10 | ||||||||||
Conversion price | 5 | ||||||||||
Series E Preferred Stock [Member] | |||||||||||
Stockholders' Equity (Details) [Line Items] | |||||||||||
Preferred stock, par value | 3.75 | ||||||||||
Conversion price | $ 7.93 | ||||||||||
Common stock percentage | 4.99% | ||||||||||
Convertible shares (in Shares) | 4.3733 | ||||||||||
Stock receivable | $ 49.20 | ||||||||||
Series G Voting Convertible Preferred Stock [Member] | |||||||||||
Stockholders' Equity (Details) [Line Items] | |||||||||||
Preferred stock, par value | 3.37 | ||||||||||
Conversion price | $ 7.93 | ||||||||||
Common stock percentage | 4.99% | ||||||||||
Convertible shares (in Shares) | 55.5978 | ||||||||||
Stock receivable | $ 187.36452 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - Schedule of preferred stock - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Preferred Units [Line Items] | ||
Preferred Shares Outstanding | 241,623 | 241,623 |
Total Liquidation Preference | $ 23,665,904 | $ 23,665,904 |
Series C-3 [Member] | ||
Preferred Units [Line Items] | ||
Preferred Shares Outstanding | 52,000 | 52,000 |
Liquidation Preference (Per Share) | $ 10 | $ 10 |
Total Liquidation Preference | $ 520,000 | $ 520,000 |
Series E [Member] | ||
Preferred Units [Line Items] | ||
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 G [Member] | ||
Preferred Units [Line Items] | ||
Preferred Shares Outstanding | 100,000 | 100,000 |
Liquidation Preference (Per Share) | $ 187.36 | $ 187.36 |
Total Liquidation Preference | $ 18,736,452 | $ 18,736,452 |
Stockholders' Equity (Details_2
Stockholders' Equity (Details) - Schedule of the assumptions used in the black scholes pricing model | 12 Months Ended |
Dec. 31, 2020 | |
Schedule of the assumptions used in the black scholes pricing model [Abstract] | |
Expected term, years | 3 years |
Volatility | 93.30% |
Dividend yield | 0.00% |
Risk-free interest rate | 1.53% |
Stockholders' Equity (Details_3
Stockholders' Equity (Details) - Schedule of fair value assumptions for black scholes - $ / shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Stockholders' Equity (Details) - Schedule of fair value assumptions for black scholes [Line Items] | ||
Expected dividend yield | 0.00% | 0.00% |
Weighted-average grant date fair value of options granted during the period (in Dollars per share) | $ 3.59 | $ 6.11 |
Minimum [Member] | ||
Stockholders' Equity (Details) - Schedule of fair value assumptions for black scholes [Line Items] | ||
Risk-free interest rate | 0.27% | 1.51% |
Expected volatility | 102.70% | 103.00% |
Expected term (years) | 5 years | 5 years |
Maximum [Member] | ||
Stockholders' Equity (Details) - Schedule of fair value assumptions for black scholes [Line Items] | ||
Risk-free interest rate | 1.67% | 2.74% |
Expected volatility | 107.90% | 110.00% |
Expected term (years) | 10 years | 10 years |
Stockholders' Equity (Details_4
Stockholders' Equity (Details) - Schedule of stock options activity and related information | 12 Months Ended |
Dec. 31, 2020USD ($)$ / sharesshares | |
Schedule of stock options activity and related information [Abstract] | |
Number of Shares Underlying Stock Options, Beginning (in Shares) | shares | 1,376,394 |
Weighted Average Exercise Price Outstanding, Beginning | $ 8.98 |
Weighted-Average Remaining Contractual Term (Years) Outstanding, Beginning | 6 years 9 months 18 days |
Aggregate Intrinsic Value Outstanding, Beginning (in Dollars) | $ | $ 1,232,545 |
Number of Shares Underlying Stock Options, Granted (in Shares) | shares | 1,111,984 |
Weighted Average Exercise Price, Granted | $ 5.11 |
Aggregate Intrinsic Value, Granted | $ 2,585,172 |
Number of Shares Underlying Stock Options, Expired/Canceled (in Shares) | shares | (6,891) |
Weighted Average Exercise Price, Expired/Canceled | $ 12.53 |
Aggregate Intrinsic Value, Expired/Canceled | |
Number of Shares Underlying Stock Options, Forfeited (in Shares) | shares | (33,800) |
Weighted Average Exercise Price, Forfeited | $ 8.51 |
Aggregate Intrinsic Value, Forfeited | $ 9,000 |
Number of Shares Underlying Stock Options, Ending (in Shares) | shares | 2,447,687 |
Weighted Average Exercise Price Outstanding, Ending | $ 7.22 |
Weighted-Average Remaining Contractual Term (Years) Outstanding, Ending | 7 years 1 month 6 days |
Aggregate Intrinsic Value Outstanding, Ending (in Dollars) | $ | $ 3,872,092 |
Number of Shares Underlying Stock Options, Vested (in Shares) | shares | 1,418,990 |
Weighted Average Exercise Price, Vested | $ 8.56 |
Weighted-Average Remaining Contractual Term (Years), Vested | 5 years 7 months 6 days |
Aggregate Intrinsic Value, Vested (in Dollars) | $ | $ 1,683,965 |
Number of Shares Underlying Stock Options, Expected to vest in the future (in Shares) | shares | 1,028,697 |
Weighted Average Exercise Price, Expected to vest in the future | $ 5.36 |
Weighted-Average Remaining Contractual Term (Years), Expected to vest in the future | 9 years 1 month 6 days |
Aggregate Intrinsic Value, Expected to vest in the future (in Dollars) | $ | $ 2,188,127 |
Stockholders' Equity (Details_5
Stockholders' Equity (Details) - Schedule of warrant activities | 12 Months Ended |
Dec. 31, 2020$ / sharesshares | |
Schedule of warrant activities [Abstract] | |
Number of Shares Underlying Warrants, Beginning | 341,328 |
Weighted Average Exercise Price, Beginning (in Dollars per share) | $ / shares | $ 6.24 |
Weighted Average Remaining Contractual Life, Beginning | 1 year 5 months 1 day |
Number of Shares Underlying Warrants, Exercised | (91,500) |
Weighted Average Exercise Price, Exercised | 4.50 |
Number of Shares Underlying Warrants, Expired | (66,680) |
Weighted Average Exercise Price, Expired | 12.13 |
Number of Shares Underlying Warrants, Ending | 183,148 |
Weighted Average Exercise Price, Ending (in Dollars per share) | $ / shares | $ 4.96 |
Weighted Average Remaining Contractual Life, Ending | 1 year 7 months 9 days |
Stockholders' Equity (Details_6
Stockholders' Equity (Details) - Schedule of Black-Scholes option pricing model using the following assumptions at the grant date of the warrant - $ / shares | 1 Months Ended | 12 Months Ended |
Sep. 25, 2019 | Dec. 31, 2018 | |
Schedule of Black-Scholes option pricing model using the following assumptions at the grant date of the warrant [Abstract] | ||
Expected Term | 2 years 10 months 17 days | 5 years |
Volatility | 111.50% | 102.85% |
Dividend yield | 0.00% | 0.00% |
Exercise Price (in Dollars per share) | $ 1.50 | |
Risk-free interest rate | 1.62% | 2.51% |
Concentrations (Details)
Concentrations (Details) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Concentrations (Details) [Line Items] | ||
Concentration risk | 10.00% | |
Revenue [Member] | ||
Concentrations (Details) [Line Items] | ||
Concentration risk | 10.00% | 10.00% |
Customers One [Member] | ||
Concentrations (Details) [Line Items] | ||
Concentration risk | 10.00% | 10.00% |
Customers One [Member] | Revenue [Member] | ||
Concentrations (Details) [Line Items] | ||
Concentration risk | 58.00% | 42.00% |
Customers Two [Member] | Revenue [Member] | ||
Concentrations (Details) [Line Items] | ||
Concentration risk | 12.00% | 18.00% |
Customers Three [Member] | Revenue [Member] | ||
Concentrations (Details) [Line Items] | ||
Concentration risk | 17.00% | |
Customers Four [Member] | Revenue [Member] | ||
Concentrations (Details) [Line Items] | ||
Concentration risk | 12.00% | |
Accounts Receivable [Member] | ||
Concentrations (Details) [Line Items] | ||
Concentration risk | 95.00% | 95.00% |
Leases (Details)
Leases (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |
Sep. 16, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Leases [Abstract] | |||
Operating lease agreement, description | seven-year operating lease | ||
Payments for leasing costs | $ 17,000 | ||
Operating lease expense | $ 66,000 | $ 6,000 | |
Operating lease liability | 1,033,000 | 4,000 | |
Classified operating lease liabilities | 109,000 | ||
Short-term leases | 924,000 | 2,000 | |
Operating lease ROU assets | 1,015,000 | 5,000 | |
Measurement lease liabilities | $ 48,000 | $ 6,000 | |
Weighted average remaining, description | the weighted average remaining lease term were 6.8 years and 2.8 years, respectively and the weighted average discount rate of 9% and 10% at December 31, 2020 and 2019, respectively. |
Leases (Details) - Schedule of
Leases (Details) - Schedule of maturities of lease liabilities - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Schedule of maturities of lease liabilities [Abstract] | ||
2021 | $ 198,000 | |
2022 | 200,000 | |
2023 | 202,000 | |
2024 | 205,000 | |
2025 | 208,000 | |
2026 and thereafter | 380,000 | |
Total future minimum lease payments | 1,393,000 | |
Less imputed interest | (360,000) | |
Total | $ 1,033,000 | $ 4,000 |
Subsequent Events (Details)
Subsequent Events (Details) - Subsequent Event [Member] | Feb. 05, 2021 | Mar. 31, 2021 |
Subsequent Events (Details) [Line Items] | ||
Subsequent event, description | the Company allocated to its ATM program an additional $25.0 million of the remaining $75.0 million available under its shelf registration statement. Giving effect to the additional $25.0 million, plus the $17.8 million available at December 31, 2020, the Company had a total of $42.8 million available under the ATM program. During January and February 2021, the Company sold an aggregate of 3,737,862 shares of its common stock under the ATM program and realized net proceeds of approximately $41.5 million. As of the filing of this Annual Report on Form 10-K, the Company has no available balance under its ATM program and it has $50.0 million available under its current shelf registration for the issuance of equity, debt or equity-linked securities. | |
Aggregate issued shares, description | the Company issued an aggregate of 92,167 shares of its common stock upon cashless exercise of 95,286 warrants and cash exercise of 21,898 warrants, resulting in net proceeds of $115,000. | |
Series G Preferred Stock [Member] | ||
Subsequent Events (Details) [Line Items] | ||
Aggregate issued shares, description | the Company issued an aggregate of 656,069 shares of its common stock upon conversion of 10,001 Series G preferred shares by Elliott and 50,000 Series C-3 preferred shares by an unrelated party. | |
New Jersey Technology [Member] | ||
Subsequent Events (Details) [Line Items] | ||
Subsequent event, description | The approval will allow the Company to sell approximately $1.3 million of the total $1.3 million in available tax benefits to an unrelated, profitable New Jersey corporation in return for approximately $1.3 million in cash. Closing is subject to NJEDA’s typical closing conditions, which are in process of completion. |