Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2016 | Aug. 01, 2016 | |
Document And Entity Information | ||
Entity Registrant Name | CorMedix Inc. | |
Entity Central Index Key | 1,410,098 | |
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2016 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Is Entity a Well-known Seasoned Issuer? | No | |
Is Entity a Voluntary Filer? | No | |
Is Entity's Reporting Status Current? | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 38,337,207 | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2,016 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) | Jun. 30, 2016 | Dec. 31, 2015 |
Current assets | ||
Cash and cash equivalents | $ 12,020,980 | $ 11,817,418 |
Restricted cash | 171,553 | 171,553 |
Short-term investments | 16,590,844 | 23,568,386 |
Trade receivables | 6,077 | 315,771 |
Inventories, net | 157,500 | 376,569 |
Prepaid research and development expenses | 2,059,486 | 430,162 |
Other prepaid expenses and current assets | 169,463 | 379,004 |
Total current assets | 31,175,903 | 37,058,863 |
Property and equipment, net | 31,935 | 37,866 |
Security deposit | 5,000 | 5,000 |
TOTAL ASSETS | 31,212,838 | 37,101,729 |
Current liabilities | ||
Accounts payable | 1,108,509 | 1,709,397 |
Accrued expenses | 1,876,671 | 1,221,557 |
Deferred revenue | 132,611 | 130,409 |
Total current liabilities | 3,117,791 | 3,061,363 |
Deferred revenue, long term | 24,349 | 28,878 |
TOTAL LIABILITIES | 3,142,140 | 3,090,241 |
COMMITMENTS AND CONTINGENCIES | ||
STOCKHOLDERS' EQUITY | ||
Preferred stock - $0.001 par value: 2,000,000 shares authorized; 450,085 shares issued and outstanding at June 30, 2016 and December 31, 2015 | 450 | 450 |
Common stock - $0.001 par value: 80,000,000 shares authorized; 37,296,523, and 35,963,348 shares issued and outstanding at June 30, 2016 and December 31, 2015, respectively | 37,297 | 35,964 |
Accumulated other comprehensive income | 90,145 | 62,130 |
Additional paid-in capital | 131,452,413 | 128,304,539 |
Accumulated deficit | (103,509,607) | (94,391,595) |
TOTAL STOCKHOLDERS' EQUITY | 28,070,698 | 34,011,488 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ 31,212,838 | $ 37,101,729 |
CONDENSED CONSOLIDATED BALANCE3
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Jun. 30, 2016 | Dec. 31, 2015 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 2,000,000 | 2,000,000 |
Preferred stock, shares issued | 450,085 | 450,085 |
Preferred stock, shares outstanding | 450,085 | 450,085 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 80,000,000 | 80,000,000 |
Common stock, shares issued | 37,296,523 | 35,963,348 |
Common stock, shares outstanding | 37,296,523 | 35,963,348 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE GAIN (LOSS) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Revenue | ||||
Net sales | $ 16,511 | $ 119,973 | $ 57,939 | $ 151,237 |
Cost of sales | (187,192) | (101,798) | (237,421) | (119,117) |
Gross profit (loss) | (170,681) | 18,175 | (179,482) | 32,120 |
Operating Expenses | ||||
Research and development | (2,772,959) | (1,797,588) | (4,862,551) | (3,032,103) |
Selling, general and administrative | (1,968,580) | (2,355,176) | (4,131,516) | (5,048,279) |
Total Operating Expenses | (4,741,539) | (4,152,764) | (8,994,067) | (8,080,382) |
Loss From Operations | (4,912,220) | (4,134,589) | (9,173,549) | (8,048,262) |
Other Income (Expense) | ||||
Interest income | 29,426 | 8,778 | 61,062 | 9,321 |
Foreign exchange transaction loss | (4,005) | (5,597) | (4,492) | (6,026) |
Value of warrants issued in connection with backstop financing | 0 | 0 | 0 | (1,583,252) |
Interest expense | (41) | (3,692) | (1,033) | (4,550) |
Total Other Income (Expense) | 25,380 | (511) | 55,537 | (1,584,507) |
Net Loss | (4,886,840) | (4,135,100) | (9,118,012) | (9,632,769) |
Other Comprehensive Income (Loss): | ||||
Unrealized gain (loss) from investments | 24,791 | (5,504) | 23,997 | (5,504) |
Foreign currency translation gain (loss) | (27,627) | (3,574) | 4,018 | (764) |
Total Other Comprehensive Income (Loss) | (2,836) | (9,078) | 28,015 | (6,268) |
Comprehensive Loss | (4,889,676) | (4,144,178) | (9,089,997) | (9,639,037) |
Net loss | (4,886,840) | (4,135,100) | (9,118,012) | (9,632,769) |
Dividends, including deemed dividends | 0 | 0 | 0 | (33,121) |
Net Loss Attributable To Common Shareholders | $ (4,886,840) | $ (4,135,100) | $ (9,118,012) | $ (9,665,890) |
Net Loss Per Common Share - Basic and Diluted | $ (0.13) | $ (0.13) | $ (0.25) | $ (0.35) |
Weighted Average Common Shares Outstanding - Basic and Diluted | 36,447,467 | 31,623,100 | 36,230,111 | 27,793,627 |
CONDENSED CONSOLIDATED STATEME5
CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS' EQUITY - 6 months ended Jun. 30, 2016 - USD ($) | Common Stock | Non-Voting Preferred Stock - Series B, Series C-2, Series C-3, Series D and Series E | Accumulated Other Comprehensive Income | Additional Paid-In Capital | Accumulated Deficit | Total |
Beginning balance (in shares) at Dec. 31, 2015 | 35,963,348 | 450,085 | ||||
Beginning balance at Dec. 31, 2015 | $ 35,964 | $ 450 | $ 62,130 | $ 128,304,539 | $ (94,391,595) | $ 34,011,488 |
Stock issued in connection with sale of common stock, Shares | 811,721 | |||||
Stock issued in connection with sale of common stock, Amount | $ 812 | 2,009,515 | 2,010,327 | |||
Stock issued in connection with warrants cashless exercised, Shares | 21,454 | |||||
Stock issued in connection with warrants cashless exercised, Amount | $ 21 | (21) | 0 | |||
Stock issued in connection with stock options exercised, Shares | 500,000 | |||||
Stock issued in connection with stock options exercised, Amount | $ 500 | 410,200 | 410,700 | |||
Stock-based compensation | 728,180 | 728,180 | ||||
Other comprehensive income | 28,015 | 28,015 | ||||
Net loss | (9,118,012) | (9,118,012) | ||||
Ending balance (in shares) at Jun. 30, 2016 | 37,296,523 | 450,085 | ||||
Ending balance at Jun. 30, 2016 | $ 37,297 | $ 450 | $ 90,145 | $ 131,452,413 | $ (103,509,607) | $ 28,070,698 |
CONDENSED CONSOLIDATED STATEME6
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (9,118,012) | $ (9,632,769) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 728,180 | 1,987,702 |
Value of warrants issued in connection with backstop financing | 0 | 1,583,252 |
Modification of warrant agreement | 0 | 112,982 |
Inventory reserve | 166,000 | 0 |
Depreciation | 8,369 | 7,115 |
Changes in operating assets and liabilities: | ||
Restricted cash | 0 | (131,994) |
Trade receivables | 317,033 | (39,960) |
Inventory | 53,068 | (252,021) |
Prepaid expenses and other current assets | (1,417,861) | (133,475) |
Accounts payable | (602,134) | 256,298 |
Accrued expenses and accrued interest | 651,720 | 301,656 |
Deferred revenue | (4,530) | (5,964) |
Net cash used in operating activities | (9,218,167) | (5,947,178) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Sale (purchase) of short-term investments | 7,001,540 | (13,382,581) |
Purchase of equipment | (1,943) | (13,797) |
Net cash provided by (used in) investing activities | 6,999,597 | (13,396,378) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from sale of common stock from an at-the-market program | 2,010,327 | 23,982,275 |
Proceeds from exercise of warrants | 0 | 14,658,160 |
Proceeds from short swing profit recovery | 0 | 28,594 |
Proceeds from exercise of stock options | 410,700 | 452,460 |
Net cash provided by financing activities | 2,421,027 | 39,121,489 |
Foreign exchange effect on cash | 1,105 | (6,637) |
NET INCREASE IN CASH | 203,562 | 19,771,296 |
CASH - BEGINNING OF PERIOD | 11,817,418 | 4,339,540 |
CASH - END OF PERIOD | 12,020,980 | 24,110,836 |
Cash paid for interest | 1,033 | 1,026 |
Supplemental Disclosure of Non-Cash Financing Activities: | ||
Conversion of preferred stock to common stock | 0 | 500 |
Unrealized gain (loss) from investments | 23,997 | (5,504) |
Conversion of wages to common stock | 0 | 50,000 |
Dividends, including deemed dividends | $ 0 | $ 33,121 |
1. Organization, Business and B
1. Organization, Business and Basis of Presentation | 6 Months Ended |
Jun. 30, 2016 | |
Organization Business And Basis Of Presentation | |
Organization, Business and Basis of Presentation | Organization and Business CorMedix Inc. (CorMedix or the Company) is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases. The Company was incorporated in the State of Delaware on July 28, 2006. In 2013, the Company formed a wholly-owned subsidiary, CorMedix Europe GmbH. The Companys primary focus is on the development of its lead product candidate, Neutrolin® (also known as CRMD003), for potential commercialization in the United States and other key markets. The Company has in-licensed the worldwide rights to develop and commercialize Neutrolin®. Neutrolin is a novel anti-infective solution for the reduction and prevention of catheter-related infections and thrombosis in patients requiring central venous catheters in clinical settings such as dialysis, critical/intensive care, and oncology. Infection and thrombosis represent key complications among critical care / intensive care and cancer patients with central venous catheters. These complications can lead to treatment delays and increased costs to the healthcare system when they occur due to hospitalizations, need for IV antibiotic treatment, long-term anticoagulation therapy, removal/replacement of the central venous catheter, related treatment costs and increased mortality. The United States Food and Drug Administration, or FDA, has designated Neutrolin as a Qualified Infectious Disease Product (QIDP) for prevention of catheter related blood stream infections in patients with end stage renal disease receiving hemodialysis through a central venous catheter. Catheter-related blood stream infections and clotting can be life-threatening. The QIDP designation provides an additional five years of market exclusivity in addition to the five years granted for a New Chemical Entity. In addition, in January 2015, the FDA granted Fast Track designation to Neutrolin Catheter Lock Solution, pursuant to the Food and Drug Administration Safety Innovation Act (FDASIA) highlighting the large unmet need to prevent infections in the U.S. healthcare system. The Fast Track designation of Neutrolin provides the Company with the opportunity to meet with the FDA on a more frequent basis during the development process, and also provides eligibility to request priority review of the marketing application. In late 2013, the Company met with the FDA to determine the pathway for U.S. marketing approval of Neutrolin. Based on those discussions, the Company plans to conduct two pivotal trials to demonstrate the safety and effectiveness of Neutrolin to secure marketing approval. The Company initiated one Phase 3 clinical trial in hemodialysis patients with a central venous catheter in December 2015 and plans to initiate one Phase 3 clinical trial in oncology patients with catheters receiving total parenteral nutrition. The Company launched its Phase 3 clinical trial in hemodialysis catheters in the U.S. in December 2015. The clinical trial, named Catheter Lock Solution Investigational Trial, or LOCK-IT-100, is a prospective, multicenter, randomized, double-blind, placebo-controlled, active control trial which aims to demonstrate the efficacy and safety of Neutrolin in preventing catheter-related bloodstream infections, or CRBSI, in subjects receiving hemodialysis therapy as treatment for end stage renal disease. The primary endpoint for the trial is time to CRBSI. The trial will evaluate whether Neutrolin is superior to the active control heparin by documenting the incidence of CRBSI and the time until the occurrence of CRBSI. Key secondary endpoints are catheter patency which is defined as required use of tissue plasminogen activating factor (tPA) or removal of catheter due to dysfunction and catheter removal for any reason. The Company plans also include conducting a Phase 3 clinical trial in oncology patients with catheters receiving total parenteral nutrition, or LOCK-IT-200. The Company is in discussion with the FDA to develop the design of the trial. Such plans are also subject to funding requirements (see Note 2). The Company received CE Mark approval for Neutrolin in 2013 and began the commercial launch of Neutrolin in Germany for the prevention of catheter-related bloodstream infections and maintenance of catheter patency in hemodialysis patients using a tunneled, cuffed central venous catheter for vascular access. To date, Neutrolin is registered and may be sold in certain European Union and Middle Eastern countries for such treatment. In September 2014, the TUV-SUD and The Medicines Evaluation Board of the Netherlands granted a label expansion for Neutrolin for expanded indications for the European Union (EU). In December 2014, the Company received approval from the Hessian District President in Germany to expand the label to include use in oncology patients receiving chemotherapy, IV hydration and IV medications via central venous catheters. The expansion also adds patients receiving medication and IV fluids via central venous catheters in intensive or critical care units (cardiac care unit, surgical care unit, neonatal critical care unit, and urgent care centers). An indication for use in total parenteral, or IV, nutrition was also approved. Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (GAAP) for interim financial information and with the instructions for Form 10-Q and Article 10 of Regulation S-X. Accordingly, the unaudited condensed consolidated financial statements do not include all information and footnotes required by GAAP for complete annual financial statements. In the opinion of management, the accompanying unaudited condensed consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation of such interim results. Interim operating results are not necessarily indicative of results that may be expected for the full year ending December 31, 2016 or for any subsequent period. These unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto of the Company which are included in the Companys Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 15, 2016. The accompanying condensed balance sheet as of December 31, 2015 has been derived from the audited financial statements included in such Form 10-K. |
2. Summary of Significant Accou
2. Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2016 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Liquidity, Risks and Uncertainties The Companys operations are subject to a number of factors that can affect its operating results and financial condition. Such factors include, but are not limited to: the results of clinical testing and trial activities of the Companys product candidates; the ability to obtain regulatory approval to market the Companys 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 Companys ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products; and the Companys ability to raise capital to support its operations. To date, the Companys commercial operations have not generated enough revenues to make the Company profitable. As of June 30, 2016, the Company had an accumulated deficit of $103.5 million, and incurred losses from operations of $9.2 million and $4.9 million for the six and three months then ended, respectively. Based on the current development plans for Neutrolin in both the U.S. and foreign markets (including the ongoing hemodialysis Phase 3 clinical trial in the U.S.) and the Companys other operating requirements, management believes that the existing cash at June 30, 2016 will be sufficient to fund operations for at least the next twelve months following the balance sheet date. However, the Company will need additional funding thereafter to complete the hemodialysis clinical trial in the U.S. which commenced in December 2015 as well as to initiate the planned Phase 3 clinical trial in oncology patients with catheters receiving total parenteral nutrition. At June 30, 2016, the Company had $8.4 million available under its at-the-market program of which approximately $1.8 million was raised subsequent to quarter end. There is no assurance that conditions will allow the Company to raise additional funds available under its at-the-market program. The Companys continued operations will depend on its ability to raise additional capital through various potential sources, such as equity and/or debt financings, strategic relationships, or out-licensing of its products in order to complete its ongoing and planned Phase 3 clinical trials and until it achieves profitability, if ever. The Company can provide no assurances that such financing or strategic relationships will be available on acceptable terms, or at all. Without this funding, the Company could be required to delay, scale back or eliminate some or all of its research and development programs which would likely have a material adverse effect on the Companys business. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates. Basis of Consolidation The condensed consolidated financial statements include the accounts of the Company and CorMedix Europe GmbH, a wholly owned subsidiary. All significant intercompany accounts and transactions have been eliminated in consolidation. Cash and Cash Equivalents Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents. The Company maintains its cash and cash equivalents in bank deposits and other interest bearing accounts, the balances of which exceed federally insured limits. Short-Term Investments The Company determines the appropriate classification of marketable securities at the time of purchase and reevaluates such designation as of each balance sheet date. Investments in marketable debt and equity securities classified as available-for-sale are reported at fair value. Fair values of the Companys investments are determined using quoted market prices in active markets for identical assets or liabilities or quoted prices for similar assets or liabilities or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Changes in fair value that are considered temporary are reported net of tax in other comprehensive income (loss). Realized gains and losses, amortization of premiums and discounts and interest and dividends earned are included in income (expense) on the condensed consolidated statements of operations and comprehensive income (loss). The cost of investments for purposes of computing realized and unrealized gains and losses is based on the specific identification method. For declines in the fair value of equity securities that are considered other-than-temporary, impairment losses are charged to other (income) expense, net. The Company considers available evidence in evaluating potential impairments of its investments, including the duration and extent to which fair value is less than cost. There were no deemed permanent impairments at June 30, 2016. The Companys marketable securities are highly liquid and consist of U.S. government agency securities, high-grade corporate obligations and commercial paper with original maturities of more than 90 days. As of June 30, 2016, all of the Companys 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 June 30, 2016 and December 31, 2015 of the Companys financial assets that are measured on a recurring basis: June 30, 2016: Amortized Cost Gross Unrealized Losses Gross Unrealized Gains Fair Value Money Market Funds included in Cash Equivalents $ 3,521,427 $ - $ - $ 3,521,427 U.S. Government Agency Securities 3,021,439 (190 ) 651 3,021,900 Corporate Securities 11,570,367 (2,185 ) 1,483 11,569,665 Commercial Paper 1,999,279 - - 1,999,279 Subtotal 16,591,085 (2,375 ) 2,134 16,590,844 Total June 30, 2016 $ 20,112,512 $ (2,375 ) $ 2,134 $ 20,112,271 December 31, 2015: Money Market Funds included in Cash Equivalents $ 3,353,067 $ - $ - $ 3,353,067 U.S. Government Agency Securities 6,531,914 (3,014 ) - 6,528,900 Corporate Securities 15,065,595 (21,637 ) 412 15,044,370 Commercial Paper 1,995,116 - - 1,995,116 Subtotal 23,592,625 (24,651 ) 412 23,568,386 Total December 31, 2015 $ 26,945,692 $ (24,651 ) $ 412 $ 26,921,453 Fair Value Measurements The Companys financial instruments recorded in the consolidated balance sheets include cash and cash equivalents, accounts receivable, investment securities, accounts payable and accrued expenses. The carrying value of certain financial instruments, primarily cash and cash equivalents, accounts receivable, accounts payable, and accrued expenses approximate their estimated fair values based upon the short-term nature of their maturity dates. The Company categorizes its financial instruments into a three-level fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets (Level 1) and the lowest priority to unobservable inputs (Level 3). If the inputs used to measure fair value fall within different levels of the hierarchy, the category level is based on the lowest priority level input that is significant to the fair value measurement of the instrument. Financial assets recorded at fair value on the Companys condensed consolidated balance sheets are categorized as follows: ● Level 1 inputsObservable 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 inputsUnobservable inputs for the asset or liability, which are supported by little or no market activity and are The following table provides the carrying value and fair value of the Companys financial assets measured at fair value on a recurring basis as of June 30, 2016 and December 31, 2015: June 30, 2016: Carrying Value Level 1 Level 2 Level 3 Money Market Funds $ 3,521,427 $ 3,521,427 $ - $ - US Government Agency Securities 3,021,900 - 3,021,900 - Corporate Securities 11,569,665 - 11,569,665 - Commercial Paper 1,999,279 - 1,999,279 - Subtotal 16,590,844 - 16,590,844 $ - Total June 30, 2016 $ 20,112,271 $ 3,521,427 $ 16,590,844 $ - December 31, 2015: Money Market Funds $ 3,353,067 $ 3,353,067 $ - $ - US Government Agency Securities 6,528,900 - 6,528,900 - Corporate Securities 15,044,370 - 15,044,370 - Commercial Paper 1,995,116 - 1,995,116 - Subtotal 23,568,386 - 23,568,386 $ - Total December 31, 2015 $ 26,921,453 $ 3,353,067 $ 23,568,386 $ - Foreign Currency Translation and Transactions The condensed consolidated financial statements are presented in U.S. Dollars (USD), the reporting currency of the Company. For the financial statements of the Companys foreign subsidiary, whose functional currency is the EURO, foreign currency asset and liability amounts, are translated into USD at end-of-period exchange rates. Foreign currency income and expenses are translated at average exchange rates in effect during the period in which the income and expenses were recognized. Translation gains and losses are included in other comprehensive income (loss). The Company has intercompany loans between the parent company based in New Jersey and its German subsidiary. The intercompany loans outstanding are not expected to be repaid in the foreseeable future and unrealized foreign exchange movements related to long-term intercompany loans are recognized in other comprehensive income. Foreign currency exchange transaction gain (loss) is the result of re-measuring transactions denominated in a currency other than the functional currency of the entity recording the transaction. Restricted Cash As of June 30, 2016 and December 31, 2015, the Companys restricted cash is in connection with the patent and utility model infringement proceedings against TauroPharm (see Note 5). The Company was required by the District Court Mannheim to provide a security deposit of approximately $132,000 to cover legal fees in the event TauroPharm is entitled to reimbursement of these costs. The Company furthermore had to provide a deposit in the amount of $40,000 in connection with the unfair competition proceedings in Cologne. Prepaid Research and Development and Other Prepaid Expenses Prepaid expenses consist of payments made in advance to vendors relating to service contracts for clinical trial development, manufacturing, preclinical development and insurance policies. These advanced payments are amortized to expense either as services are performed or over the relevant service period using the straight-line method. Inventories, net Inventories are valued at the lower of cost or market on a first in, first out basis. Inventories consist of raw materials (including labeling and packaging), work-in-process, and finished goods for the Neutrolin product. Inventories consist of the following: June 30, 2016 December 31, 2015 Raw materials $ 221,355 $ 244,459 Work in process 355,297 424,622 Finished goods 46,848 7,488 Inventory reserve (466,000 ) (300,000 ) Total $ 157,500 $ 376,569 Accrued Expenses Accrued expenses consist of the following: June 30, 2016 December 31, 2015 Professional and consulting fees $ 240,833 $ 282,975 Accrued payroll and payroll taxes 703,224 532,084 Clinical trial and manufacturing development 853,150 226,042 Monitoring program fees 40,207 65,076 Statutory taxes 963 67,236 Other 38,294 48,144 Total $ 1,876,671 $ 1,221,557 Revenue Recognition The Company recognizes revenue in accordance with SEC Staff Accounting Bulletin (SAB) Topic 13, Revenue Recognition Revenue Recognition . Deferred Revenue In October 2015, the Company shipped product with less than 75% of its remaining shelf life to a customer and issued a guarantee that the specific product shipped would be replaced by the Company if the customer was not able to sell the product before it expired. As a result of this warranty, the Company may have an additional performance obligation (i.e. accept returned product and deliver new product to the customer) if the customer is unable to sell such product. Due to limited sales experience with the customer, the Company is unable to estimate the amount of the warranty obligation that may be incurred as a result of this shipment. Therefore, the Company has deferred the revenue and related cost of sales associated with the shipment of this product. Since the Company will be unable to resell the expired product if returned by the customer, the deferred revenue and related cost of sales is presented net as Deferred Revenue on the condensed consolidated balance sheet which amounted to approximately $124,000 and $121,000 at June 30, 2016 and December 31, 2015, respectively. In August 2014, the Company entered into an exclusive distribution agreement (the Wonik Agreement) with Wonik Corporation, a South Korean company, to market, sell and distribute Neutrolin for hemodialysis and oncolytic patients upon receipt of regulatory approval in Korea. Upon execution of the Wonik Agreement, Wonik paid the Company a non-refundable $50,000 payment and will pay an additional $50,000 upon receipt of the product registration necessary to sell Neutrolin in the Republic of Korea (the Territory). The term of the Wonik Agreement commenced on August 8, 2014 and will continue for three years after the first commercial sale of Neutrolin in the Territory. The non-refundable up-front payment has been recorded as deferred revenue and will be recognized as revenue on a straight-line basis over the contractual term of the Agreement. The Company recognized $2,200 revenue related to the Wonik agreement for each of the three months ended June 30, 2016 and 2015. Deferred revenue short-term balance at June 30, 2016 and December 31, 2015 amounted to approximately $9,000 for each period and deferred revenue long-term balances at June 30, 2016 and December 31, 2015 amounted to approximately $24,000 and $29,000, respectively. Loss per common share Basic loss per common share excludes any potential dilution and is computed by dividing net loss by the weighted average number of common shares outstanding during the period. Diluted net loss per common share reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that then shared in the earnings of the entity. However, since their effect is anti-dilutive, the Company has excluded potentially dilutive shares. The following potentially dilutive shares have been excluded from the calculation of diluted net loss per share as their effect would be anti-dilutive. Six Months Ended June 30, 2016 June 30, 2015 Series C non-voting convertible preferred stock 2,865,000 2,865,000 Series D non-voting convertible preferred stock 1,479,240 1,479,240 Series E non-voting convertible preferred stock 1,959,759 1,959,759 Shares underlying outstanding warrants 4,006,468 4,422,188 Shares underlying outstanding stock options 4,134,545 3,594,545 Total 14,445,012 14,320,732 Stock-Based Compensation The Company accounts for stock options granted to employees, officers and directors according to ASC No. 718, Compensation Stock Compensation The Company accounts for stock options granted to non-employees on a fair value basis using the Black-Scholes option pricing model in accordance with ASC 718 and ASC No. 505-50, Equity-Based Payments to Non-Employees Stock compensation expense is recognized by applying the expected forfeiture rate during the vesting period to the fair value of the award. The estimation of the number of stock awards that will ultimately vest requires judgment, and to the extent actual results or updated estimates differ from the Companys current estimates, compensation expense may need to be revised. The Company considers many factors when estimating expected forfeitures for stock awards granted to employees, officers and directors, including types of awards, employee class, and an analysis of historical forfeitures. Research and Development Research and development costs are charged to expense as incurred. Research and development includes fees associated with operational consultants, contract clinical research organizations, contract manufacturing organizations, clinical site fees, contract laboratory research organizations, contract central testing laboratories, licensing activities, and allocated executive, human resources and facilities expenses. The Company accrues for costs incurred as the services are being provided by monitoring the status of the trial and the invoices received from its external service providers. Costs related to the acquisition of technology rights and patents for which development work is still in process are charged to operations as incurred and considered a component of research and development expense. |
3. Stockholders' Equity
3. Stockholders' Equity | 6 Months Ended |
Jun. 30, 2016 | |
STOCKHOLDERS' EQUITY | |
Stockholders' Equity | Common Stock The Company has entered into an At-the-Market Issuance Sales Agreement (the Sales Agreement) with MLV & Co. LLC, now a subsidiary of FBR & Co. (MLV), under which the Company may issue and sell up to $40.0 million of shares of its common stock from time to time through MLV acting as agent, subject to limitations imposed by the Company, such as the number or dollar amount of shares registered under the registration statement to which the offering relates. When the Company wishes to issue and sell common stock under the Sales Agreement, it notifies MLV of the number of shares to be issued, the dates on which such sales are anticipated to be made, any minimum price below which sales may not be made and other sales parameters as the Company deems appropriate. MLV is entitled to a commission of up to 3% of the gross proceeds from the sale of common stock sold under the Sales Agreement. The shares of common stock to be sold under the Sales Agreement are registered under an effective registration statement filed with the SEC. During the six months ended June 30, 2016, the Company issued 811,721 shares of common stock under the Sales Agreement and realized net proceeds of approximately $2.0 million. During the six months ended June 30, 2016, the Company issued the following shares of its common stock upon exercise of stock options resulting in gross proceeds of $410,700 to the Company: ● 30,000 shares of common stock with an exercise price of $0.29 per share; ● 300,000 shares of common stock with an exercise price of $0.68 per share; ● 120,000 shares of common stock with an exercise price of $0.90 per share; and ● 50,000 shares of common stock with an exercise price of $1.80 per share. During the six months ended June 30, 2016, the Company issued 21,454 shares of its common stock upon a cashless exercise of 25,000 warrants. Stock Options During the six months ended June 30, 2016, the Company granted ten-year non-qualified stock options under the 2013 Plan covering an aggregate of 1,041,000 shares of the Companys common stock to its officers, directors, employees and consultants. During the six months ended June 30, 2016 and 2015, total compensation expense for stock options issued to employees, directors, officers and consultants was $728,180 and $1,987,702, respectively and $286,110 and $960,778 for the three months ended June 30, 2016 and 2015, respectively. The fair value of the grants were determined using the Black-Scholes option pricing model with the following assumptions: Six Months Ended June 30, 2016 Expected Term 5 -10 years Volatility 96% - 98% Dividend yield 0.0% Risk-free interest rate 1.25% - 1.94% 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 Companys stock options is calculated based on the historical volatility since the initial public offering of the Companys common stock in March 2010. The expected dividend yield of 0.0% reflects the Companys current and expected future policy for dividends on the Companys 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 Companys awards. A summary of the Companys stock option activity and related information for the six months ended June 30, 2016 is as follows: Shares Weighted Average Exercise Price Outstanding at beginning of period 3,600,045 $ 1.82 Exercised (500,000 ) $ 0.82 Forfeited (156,500 ) $ 2.03 Expired - - Granted 1,041,000 $ 2.14 Outstanding at end of period 3,984,545 $ 2.02 Options exercisable 3,047,123 $ 1.95 Weighted-average fair value of options granted during the period $ 1.64 Weighted average remaining contractual life of stock options outstanding (years) 6.3 Weighted average remaining contractual life of stock options exercisable (years) 5.2 Weighted average vesting period over which total compensation expense related to non-vested options not yet recognized (years) 1.1 Compensation expense related to non-vested options not yet recognized $ 1,193,963 Aggregate intrinsic value of stock options exercised $ 980,039 Aggregate intrinsic value of stock options outstanding $ 1,783,259 The aggregate intrinsic value is calculated as the difference between the exercise prices of the underlying options and the quoted closing price of the common stock of the Company at the end of the reporting period for those options that have an exercise price below the quoted closing price. Warrants The following table is the summary of warrant activity for the six months ended June 30, 2016: Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life Outstanding at beginning of period 4,422,188 $ 1.80 3.07 Granted - - - Expired (390,720 ) $ 3.44 - Exercised (25,000 ) $ 0.40 - Outstanding at end of period 4,006,468 $ 1.65 2.86 |
4. Related Party Transactions
4. Related Party Transactions | 6 Months Ended |
Jun. 30, 2016 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | On March 3, 2015, the Company entered into a backstop agreement with an existing institutional investor, Manchester Securities Corp., a wholly owned subsidiary of Elliott Associates, L.P., and a beneficial holder of more than 5% of the Companys outstanding common stock. Pursuant to the backstop agreement, Manchester had agreed to lend the Company, at its request, up to $4,500,000 less the dollar amount of gross proceeds received by the Company upon the exercise of warrants to purchase common stock issued in connection with its initial public offering, or IPO, on or before April 30, 2015, provided that the loan could not exceed $3,000,000. As a result of the backstop agreement, in March 2015, the Company issued five-year warrants exercisable for an aggregate of up to 283,400 common shares with an exercise price of $7.00 per share and recorded an expense of $1,583,000 for the value of these warrants. The backstop agreement was not accessed. Pursuant to the backstop agreement, the Company granted Manchester the right for as long as it or its affiliates hold any of the Companys common stock or securities convertible into its common stock to appoint up to two members to the Companys board of directors and/or to have up to two observers attend board meetings in a non-voting capacity. Manchester appointed one director in August 2015 and appointed another director in April 2016. |
5. Commitments and Contingencie
5. Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Contingency Matters On September 9, 2014, the Company filed in the District Court of Mannheim, Germany a patent infringement action against TauroPharm GmbH and Tauro-Implant GmbH as well as their respective CEOs (the Defendants) claiming infringement of the Companys European Patent EP 1 814 562 B1, which was granted by the European Patent Office (the EPO) on January 8, 2014 (the Prosl European Patent). The Prosl European Patent covers a low dose heparin catheter lock solution for maintaining patency and preventing infection in a hemodialysis catheter. In this action, the Company claims that the Defendants infringe on the Prosl European Patent by manufacturing and distributing catheter locking solutions to the extent they are covered by the claims of the Prosl European Patent. The Company believes that its patent is sound, and is seeking injunctive relief and raising claims for information, rendering of accounts, calling back, destruction and damages. Separately, TauroPharm has filed an opposition with the EPO against the Prosl European Patent alleging that it lacks novelty and inventive step. The Company cannot predict what other defenses the Defendants may raise, or the ultimate outcome of either of these related matters. In the same complaint against the same Defendants, the Company also alleged an infringement (requesting the same remedies) of NDPs utility model DE 20 2005 022 124 U1 (the Utility Model), which the Company believes is fundamentally identical to the Prosl European Patent in its main aspects and claims. The Court separated the two proceedings and the Prosl European Patent and the Utility Model claims are now being tried separately. TauroPharm has filed a cancellation action against the Utility Model before the German Patent and Trademark Office (the German PTO) based on the similar arguments as those in the opposition against the Prosl European Patent. On March 27, 2015, the District Court held a hearing to evaluate whether the Utility Model has been infringed by TauroPharm in connection with the manufacture, sale and distribution of its TauroLock-HEP100TM and TauroLock-HEP500TM products. A hearing before the same court was held on January 30, 2015 on the separate, but related, question of infringement of the Prosl European Patent by TauroPharm. The Court issued its decisions on May 8, 2015 staying both proceedings. In its decisions, the Court found that the commercialization by TauroPharm in Germany of its TauroLock catheter lock solutions Hep100 and Hep500 infringes both the Prosl European Patent and the Utility Model and further that there is no prior use right that would allow TauroPharm to continue to make, use or sell its product in Germany. However, the Court declined to issue an injunction in favor of the Company that would preclude the continued commercialization by TauroPharm based upon its finding that there is a sufficient likelihood that the EPO, in the case of the Prosl European Patent, or the German PTO, in the case of the Utility Model, may find that such patent or utility model is invalid. Specifically, the Court noted the possible publication of certain instructions for product use that may be deemed to constitute prior art. As such, the District Court determined that it will defer any consideration of the request by the Company for injunctive and other relief until such time as the EPO or the German PTO has ruled on the underlying validity of the Prosl European Patent and the Utility Model. The opposition proceeding against the Prosl European Patent before the EPO is ongoing. The EPO held a hearing in the opposition proceeding on November 25, 2015. In its preliminary consideration of the matter, the EPO (and the German PTO) had regarded the patent as not inventive or novel due to publication of prior art. However, the EPO did not issue a decision at the end of the hearing but adjourned the matter due to the fact that the panel was of the view that Claus Herdeis, one of the managing directors of TauroPharm, has to be heard as a witness in a further hearing in order to close some gaps in the documentation presented by TauroPharm as regards the publication of the prior art. No date has yet been scheduled for such further hearing as of the filing of this 10-Q. While the Company continues to believe that the referenced publication and instructions for use do not, in fact, constitute prior art and that the Prosl European Patent will be found to be valid by the EPO, there can be no assurance that the Company will prevail in this matter. The German PTO held a hearing in the validity proceedings relating to the Utility Model on June 29, 2016, at which the panel affirmed its preliminary finding that the Utility Model was invalid based upon prior publication of a reference to the benefits that may be associated with adding heparin to a taurolidine based solution. The decision is subject to appeal and has only a declaratory effect, as the Utility Model had expired in November 2015. Furthermore, it has no bearing on the ongoing consideration of the validity and possible infringement of the Prosl Patent by EPO. 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 TauroPharms products TauroLockTM, TauroLock-HEP100 and TauroLock-HEP500. The Company seeks a cease and desist order against TauroPharm from continuing to manufacture and sell any product containing taurolidine (the active pharmaceutical ingredient (API) of Neutrolin) and citric acid in addition to possible other components, damages for any sales in the past and the removal of all such products from the market. An initial hearing in the District Court of Cologne, Germany was held on November 19, 2015 to consider the Companys claims. In this hearing, the presiding judge explained that the court needed more information with regard to several aspects of the case. As a consequence, the court issued an interim decision in the form of a court order outlining several issues of concern that relate primarily to the court's interest in clarifying the facts and reviewing any and all available documentation, in particular with regard to the question which specific know-how was provided to TauroPharm by whom and when. The Company's legal team has prepared the requested reply and produced the respective documentation. TauroPharm has also filed another writ within the same deadline and both parties have filed further writs at the end of April setting out their respective argumentation in more detail. A further oral hearing has been scheduled for November 15, 2016. In connection with the aforementioned patent and utility model infringement proceedings against TauroPharm, the Company was required by the District Court Mannheim to provide a security deposit of approximately $132,000 to cover legal fees in the event TauroPharm is entitled to reimbursement of these costs. The Company recorded the deposit as restricted cash for the year ended December 31, 2015. The Company furthermore had to provide a deposit in the amount of $40,000 in connection with the unfair competition proceedings in Cologne. On July 7, 2015, a putative class action lawsuit was commenced against the Company and certain of its current and former officers in the United States District Court for the District of New Jersey, captioned Li v. Cormedix Inc., et al. On December 1, 2015, Lead Plaintiff filed an Amended Complaint asserting claims that the Company and Steven Lefkowitz, Randy Milby and Harry OGrady (the Cormedix Defendants) violated Section 10(b) of the Exchange Act and Rule 10b-5 promulgated thereunder and Section 20(a) of the Exchange Act. The Amended Complaint also names as defendants several unrelated entities that allegedly were paid stock promoters. Lead Plaintiff alleges generally that the Cormedix Defendants made materially false or misleading statements and omissions concerning, among other things, the competitive landscape for the Companys Neutrolin product and the alleged use of stock promoters. The Amended Complaint seeks unspecified damages, interest, attorneys fees, and other costs. On February 1, 2016, the Cormedix Defendants filed a motion to dismiss all claims asserted against them in the Amended Complaint on the grounds, among others, that the Amended Complaint fails to adequately allege: (1) material misstatements or omissions; (2) scienter by any of the Cormedix Defendants; or (3) loss causation. The Court heard oral argument on this motion on July 18, 2016 and took the matter under advisement. On May 13, 2016, a putative shareholder derivative action was filed in the Superior Court of New Jersey against the Company and certain present and former directors and officers captioned Raval v. Milby, et. al. The Company believes that it has substantial legal and factual defenses to the claims in the Securities Class Action and the Derivative Action and intends to continue vigorously defending those cases. Commitments Manufacturing Navinta LLC, a U.S.-based API developer, has provided API manufacturing (manufactured in India at an FDA-compliant facility) and a Drug Master File for CRMD003, pursuant to an original supply agreement dated December 7, 2009 (the Navinta Agreement). The original Navinta Agreement provided that Navinta would supply taurolidine (the API for CRMD003) to the Company on an exclusive worldwide basis in the field of the prevention and treatment of human infection and/or dialysis so long as the Company purchases a minimum of $2,250,000 of product on an annual basis for five years following the Companys first commercial sale of a product incorporating taurolidine. The Company did not purchase the required amounts and as a result, lost its exclusive manufacturing rights. The Company would have also been required to make certain cash payments to Navinta upon the achievement of certain sales-based milestones which was based on a tiered approach and was not to commence until the Company achieves a designated net sales threshold. The maximum aggregate amount of such payments, assuming achievement of all milestones, would have been $1,975,000 over five years. There were no milestones achieved during the six months ended June 30, 2016. On March 24, 2015, the Company and Navinta LLC entered into an amendment to the Navinta Agreement to extend the term of the Navinta Agreement to March 31, 2016 and to lower the price per kilogram of API that the Company purchases from Navinta LLC under the Navinta Agreement. The Company also agreed to purchase a minimum amount of product from Navinta LLC during 2015, which replaced the prior minimum purchase requirement. The Navinta Agreement expired on March 31, 2016 without delivery of the minimum purchase requirement. The Agreement will not be renewed and no further obligations for purchase nor milestone payments for sales exist. The Company has developed a program aimed at reducing the cost of goods of Neutrolin through a more efficient, custom synthesis of the active ingredient taurolidine. As part of that program, on April 8, 2015, the Company entered into a Preliminary Services Agreement with [RC]2 Pharma Connect LLC (RC2), pursuant to which RC2 will coordinate certain manufacturing services related to taurolidine. Specifically, RC2 will undertake a critical parameters evaluation for the Companys manufacturing needs and coordinate the cGMP processes set forth in the agreement that the Company believes are necessary for the submission of its planned new drug application for Neutrolin to the FDA, as well as any foreign regulatory applications. The total cost for RC2s services under the preliminary services agreement is expected to be approximately $1.7 million which is expected to be incurred through the fourth quarter of 2016. During the three and six months ended June 30, 2016, the Company recognized research and development expense of $35,000 and $71,000, respectively for its services related to the agreement and $380,000 for the three and six months ended June 30, 2015. The Company anticipates a significant cost reduction commercially for the cost of taurolidine. The Company also has several service agreements with RC2 for the manufacture of clinical supplies to support its ongoing and planned Phase 3 clinical trials for an aggregate amount of $3.4 million. During the three and six months ended June 30, 2016, the Company recognized research and development expense of approximately $355,000 and $743,000, respectively, related to these agreements. The Company may terminate these agreements upon 30 days written notice and is only obligated for project costs and reasonable project shut down costs provided through the date of termination. Clinical and Regulatory In December 2015, CorMedix signed a Master Service Agreement and Work Order (the Master Service Agreement) with PPD Development, LP (PPD) for a $19.2 million Phase 3 multicenter, double-blind, randomized active control study (the Phase 3 Clinical Trial) to demonstrate the safety and effectiveness of Neutrolin in preventing catheter-related bloodstream infections and blood clotting in subjects receiving hemodialysis therapy as treatment for end stage renal disease. The Phase 3 Clinical Trial is expected to accrue up to 632 patients in approximately 70 sites in the U.S. The Phase 3 Clinical Trial will stop when there are 162 incidences. The Data and Safety Monitoring Board is projected to do an interim analysis for safety when half of the patients are enrolled or there are 81 events, whichever occurs first. This is projected to be in the fourth quarter of 2016. During the three and six months ended June 30, 2016, the Company recognized $1.1 million and $2 million research and development expense related to this agreement. In-Licensing In 2008, the Company entered into a License and Assignment Agreement (the NDP License Agreement) with NDP. Pursuant to the NDP License Agreement, NDP granted the Company exclusive, worldwide licenses for certain antimicrobial catheter lock solutions, processes for treating and inhibiting infections, a biocidal lock system and a taurolidine delivery apparatus, and the corresponding United States and foreign patents and applications (the NDP Technology). The Company acquired such licenses and patents through its assignment and assumption of NDPs rights under certain separate license agreements by and between NDP and Dr. Hans-Dietrich Polaschegg, Dr. Klaus Sodemann and Dr. Johannes Reinmueller. As consideration in part for the rights to the NDP Technology, the Company paid NDP an initial licensing fee of $325,000 and granted NDP a 5% equity interest in the Company, consisting of 39,980 shares of the Companys common stock. In addition, the Company is required to make payments to NDP upon the achievement of certain regulatory and sales-based milestones. Certain of the milestone payments are to be made in the form of shares of common stock currently held in escrow for NDP, and other milestone payments are to be paid in cash. The maximum aggregate number of shares issuable upon achievement of milestones is 145,543 shares. In 2014, a certain milestone was achieved resulting in the release of 36,386 shares held in escrow. The number of shares held in escrow as of June 30, 2016 is 109,157 shares of common stock. The maximum aggregate amount of cash payments upon achievement of milestones is $3,000,000 with $2,500,000 remaining at June 30, 2016. Events that trigger milestone payments include but are not limited to the reaching of various stages of regulatory approval and upon achieving certain worldwide net sales amounts. There were no milestones achieved during the three and six months ended June 30, 2016. The NDP License Agreement may be terminated by the Company on a country-by-country basis upon 60 days prior written notice. If the NDP License Agreement is terminated by either party, the Companys rights to the NDP Technology will revert back to NDP. Other On August 3, 2015, the Company entered into a Release of Claims and Severance Modification with Randy Milby, its Chief Executive Officer, due to the anticipated termination of Mr. Milbys employment. In exchange for the release of various claims by Mr. Milby against the Company, including claims related to his employment with Company and the termination of same and claims for additional compensation or benefits other than the compensation and benefits set forth in his employment agreement, the Company agreed to amend Mr. Milbys employment agreement, dated as of March 31, 2014, to specify that Mr. Milby may not compete against the Company by engaging in any business involving the development or commercialization of (i) a preventive anti-infective product that would be a direct competitor of Neutrolin or (ii) a product containing taurolidine. The non-compete term did not change and remains at twelve months following termination of his employment. The employment agreement was also amended to allow Mr. Milby a period in which to exercise all vested options and warrants until the later of 60 months following the termination date of his employment or 60 months following the date on which his service on the Companys Board of Directors ends, provided in no event shall he be able to exercise after the respective expiration date of any stock option or warrant. During the year ended December 31, 2015, the Company recorded non-cash expense of $507,341 as a result of this modification. Pursuant to the terms of his employment agreement, Mr. Milby will be entitled to receive his base salary and benefits for a period of twelve months following the effective date of the termination of his employment, or, in the case of benefits, until such time as he receives equivalent coverage and benefits under plans and programs of a subsequent employer if such receipt is prior to the expiration of the twelve month period. To the extent any of the aforementioned benefits cannot be provided to former employees, the Company will pay Mr. Milby a lump-sum payment in the amount necessary to allow Mr. Milby to purchase the equivalent benefits. The Company accrued $325,000 of severance pay during the year ended December 31, 2015 which remained unpaid at June 30, 2016. The Company entered into sublease for 4,700 square feet of office space in Bedminster, New Jersey, which sublease runs from April 1, 2015 until March 31, 2018. Rent is $5,000 per month plus occupancy costs such as utilities, maintenance and taxes. In accordance with the lease agreement, the Company has deposited $5,000 with the landlord, the equivalent of one month rent. The Companys subsidiary entered into a lease agreement for its offices in Fulda, Germany with ITZ GmbH. The lease has a term of 36 months which commenced on September 1, 2013 for a base monthly payment of 498. The total 36 month lease obligation is approximately 17,900 ($20,000). Rent expense for the three and six months ended June 30, 2016 was $16,000 and $35,000, respectively and $16,000 and $40,000 for the three and six months ended June 30, 2015, respectively. Under the Companys current lease agreements, the total remaining lease obligation as of June 30, 2016 is set forth below: 2017 $ 62,053 2018 45,157 Total $ 107,210 |
6. Subsequent Events
6. Subsequent Events | 6 Months Ended |
Jun. 30, 2016 | |
Subsequent Events [Abstract] | |
Subsequent Events | From July 1, 2016 through August 1, 2016, the Company issued 1,040,684 shares of common stock under its at-the-market program and realized net proceeds of approximately $1.8 million. |
2. Summary of Significant Acc13
2. Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2016 | |
Accounting Policies [Abstract] | |
Liquidity, Risks and Uncertainties | The Companys operations are subject to a number of factors that can affect its operating results and financial condition. Such factors include, but are not limited to: the results of clinical testing and trial activities of the Companys product candidates; the ability to obtain regulatory approval to market the Companys 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 Companys ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products; and the Companys ability to raise capital to support its operations. To date, the Companys commercial operations have not generated enough revenues to make the Company profitable. As of June 30, 2016, the Company had an accumulated deficit of $103.5 million, and incurred losses from operations of $9.2 million and $4.9 million for the six and three months then ended, respectively. Based on the current development plans for Neutrolin in both the U.S. and foreign markets (including the ongoing hemodialysis Phase 3 clinical trial in the U.S.) and the Companys other operating requirements, management believes that the existing cash at June 30, 2016 will be sufficient to fund operations for at least the next twelve months following the balance sheet date. However, the Company will need additional funding thereafter to complete the hemodialysis clinical trial in the U.S. which commenced in December 2015 as well as to initiate the planned Phase 3 clinical trial in oncology patients with catheters receiving total parenteral nutrition. At June 30, 2016, the Company had $8.4 million available under its at-the-market program of which approximately $1.8 million was raised subsequent to quarter end. There is no assurance that conditions will allow the Company to raise additional funds available under its at-the-market program. The Companys continued operations will depend on its ability to raise additional capital through various potential sources, such as equity and/or debt financings, strategic relationships, or out-licensing of its products in order to complete its ongoing and planned Phase 3 clinical trials and until it achieves profitability, if ever. The Company can provide no assurances that such financing or strategic relationships will be available on acceptable terms, or at all. Without this funding, the Company could be required to delay, scale back or eliminate some or all of its research and development programs which would likely have a material adverse effect on the Companys business. |
Use of Estimates | The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates. |
Basis of Consolidation | The condensed consolidated financial statements include the accounts of the Company and CorMedix Europe GmbH, a wholly owned subsidiary. All significant intercompany accounts and transactions have been eliminated in consolidation. |
Cash and Cash Equivalents | Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents. The Company maintains its cash and cash equivalents in bank deposits and other interest bearing accounts, the balances of which exceed federally insured limits. |
Short term investments | The Company determines the appropriate classification of marketable securities at the time of purchase and reevaluates such designation as of each balance sheet date. Investments in marketable debt and equity securities classified as available-for-sale are reported at fair value. Fair values of the Companys investments are determined using quoted market prices in active markets for identical assets or liabilities or quoted prices for similar assets or liabilities or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Changes in fair value that are considered temporary are reported net of tax in other comprehensive income (loss). Realized gains and losses, amortization of premiums and discounts and interest and dividends earned are included in income (expense) on the condensed consolidated statements of operations and comprehensive income (loss). The cost of investments for purposes of computing realized and unrealized gains and losses is based on the specific identification method. For declines in the fair value of equity securities that are considered other-than-temporary, impairment losses are charged to other (income) expense, net. The Company considers available evidence in evaluating potential impairments of its investments, including the duration and extent to which fair value is less than cost. There were no deemed permanent impairments at June 30, 2016. The Companys marketable securities are highly liquid and consist of U.S. government agency securities, high-grade corporate obligations and commercial paper with original maturities of more than 90 days. As of June 30, 2016, all of the Companys 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 June 30, 2016 and December 31, 2015 of the Companys financial assets that are measured on a recurring basis: June 30, 2016: Amortized Cost Gross Unrealized Losses Gross Unrealized Gains Fair Value Money Market Funds included in Cash Equivalents $ 3,521,427 $ - $ - $ 3,521,427 U.S. Government Agency Securities 3,021,439 (190 ) 651 3,021,900 Corporate Securities 11,570,367 (2,185 ) 1,483 11,569,665 Commercial Paper 1,999,279 - - 1,999,279 Subtotal 16,591,085 (2,375 ) 2,134 16,590,844 Total June 30, 2016 $ 20,112,512 $ (2,375 ) $ 2,134 $ 20,112,271 December 31, 2015: Money Market Funds included in Cash Equivalents $ 3,353,067 $ - $ - $ 3,353,067 U.S. Government Agency Securities 6,531,914 (3,014 ) - 6,528,900 Corporate Securities 15,065,595 (21,637 ) 412 15,044,370 Commercial Paper 1,995,116 - - 1,995,116 Subtotal 23,592,625 (24,651 ) 412 23,568,386 Total December 31, 2015 $ 26,945,692 $ (24,651 ) $ 412 $ 26,921,453 |
Fair value measurements | The Companys financial instruments recorded in the consolidated balance sheets include cash and cash equivalents, accounts receivable, investment securities, accounts payable and accrued expenses. The carrying value of certain financial instruments, primarily cash and cash equivalents, accounts receivable, accounts payable, and accrued expenses approximate their estimated fair values based upon the short-term nature of their maturity dates. The Company categorizes its financial instruments into a three-level fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets (Level 1) and the lowest priority to unobservable inputs (Level 3). If the inputs used to measure fair value fall within different levels of the hierarchy, the category level is based on the lowest priority level input that is significant to the fair value measurement of the instrument. Financial assets recorded at fair value on the Companys condensed consolidated balance sheets are categorized as follows: ● Level 1 inputsObservable 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 inputsUnobservable inputs for the asset or liability, which are supported by little or no market activity and are The following table provides the carrying value and fair value of the Companys financial assets measured at fair value on a recurring basis as of June 30, 2016 and December 31, 2015: June 30, 2016: Carrying Value Level 1 Level 2 Level 3 Money Market Funds $ 3,521,427 $ 3,521,427 $ - $ - US Government Agency Securities 3,021,900 - 3,021,900 - Corporate Securities 11,569,665 - 11,569,665 - Commercial Paper 1,999,279 - 1,999,279 - Subtotal 16,590,844 - 16,590,844 $ - Total June 30, 2016 $ 20,112,271 $ 3,521,427 $ 16,590,844 $ - December 31, 2015: Money Market Funds $ 3,353,067 $ 3,353,067 $ - $ - US Government Agency Securities 6,528,900 - 6,528,900 - Corporate Securities 15,044,370 - 15,044,370 - Commercial Paper 1,995,116 - 1,995,116 - Subtotal 23,568,386 - 23,568,386 $ - Total December 31, 2015 $ 26,921,453 $ 3,353,067 $ 23,568,386 $ - |
Foreign Currency Translation and Transactions | The condensed consolidated financial statements are presented in U.S. Dollars (USD), the reporting currency of the Company. For the financial statements of the Companys foreign subsidiary, whose functional currency is the EURO, foreign currency asset and liability amounts, are translated into USD at end-of-period exchange rates. Foreign currency income and expenses are translated at average exchange rates in effect during the period in which the income and expenses were recognized. Translation gains and losses are included in other comprehensive income (loss). The Company has intercompany loans between the parent company based in New Jersey and its German subsidiary. The intercompany loans outstanding are not expected to be repaid in the foreseeable future and unrealized foreign exchange movements related to long-term intercompany loans are recognized in other comprehensive income. Foreign currency exchange transaction gain (loss) is the result of re-measuring transactions denominated in a currency other than the functional currency of the entity recording the transaction. |
Restricted Cash | As of June 30, 2016 and December 31, 2015, the Companys restricted cash is in connection with the patent and utility model infringement proceedings against TauroPharm (see Note 5). The Company was required by the District Court Mannheim to provide a security deposit of approximately $132,000 to cover legal fees in the event TauroPharm is entitled to reimbursement of these costs. The Company furthermore had to provide a deposit in the amount of $40,000 in connection with the unfair competition proceedings in Cologne. |
Prepaid Research and Development and Other Prepaid Expenses | Prepaid expenses consist of payments made in advance to vendors relating to service contracts for clinical trial development, manufacturing, preclinical development and insurance policies. These advanced payments are amortized to expense either as services are performed or over the relevant service period using the straight-line method. |
Inventories, net | Inventories are valued at the lower of cost or market on a first in, first out basis. Inventories consist of raw materials (including labeling and packaging), work-in-process, and finished goods for the Neutrolin product. Inventories consist of the following: June 30, 2016 December 31, 2015 Raw materials $ 221,355 $ 244,459 Work in process 355,297 424,622 Finished goods 46,848 7,488 Inventory reserve (466,000 ) (300,000 ) Total $ 157,500 $ 376,569 |
Accrued Expenses | Accrued expenses consist of the following: June 30, 2016 December 31, 2015 Professional and consulting fees $ 240,833 $ 282,975 Accrued payroll and payroll taxes 703,224 532,084 Clinical trial and manufacturing development 853,150 226,042 Monitoring program fees 40,207 65,076 Statutory taxes 963 67,236 Other 38,294 48,144 Total $ 1,876,671 $ 1,221,557 |
Revenue Recognition | The Company recognizes revenue in accordance with SEC Staff Accounting Bulletin (SAB) Topic 13, Revenue Recognition Revenue Recognition . |
Deferred Revenue | In October 2015, the Company shipped product with less than 75% of its remaining shelf life to a customer and issued a guarantee that the specific product shipped would be replaced by the Company if the customer was not able to sell the product before it expired. As a result of this warranty, the Company may have an additional performance obligation (i.e. accept returned product and deliver new product to the customer) if the customer is unable to sell such product. Due to limited sales experience with the customer, the Company is unable to estimate the amount of the warranty obligation that may be incurred as a result of this shipment. Therefore, the Company has deferred the revenue and related cost of sales associated with the shipment of this product. Since the Company will be unable to resell the expired product if returned by the customer, the deferred revenue and related cost of sales is presented net as Deferred Revenue on the condensed consolidated balance sheet which amounted to approximately $124,000 and $121,000 at June 30, 2016 and December 31, 2015, respectively. In August 2014, the Company entered into an exclusive distribution agreement (the Wonik Agreement) with Wonik Corporation, a South Korean company, to market, sell and distribute Neutrolin for hemodialysis and oncolytic patients upon receipt of regulatory approval in Korea. Upon execution of the Wonik Agreement, Wonik paid the Company a non-refundable $50,000 payment and will pay an additional $50,000 upon receipt of the product registration necessary to sell Neutrolin in the Republic of Korea (the Territory). The term of the Wonik Agreement commenced on August 8, 2014 and will continue for three years after the first commercial sale of Neutrolin in the Territory. The non-refundable up-front payment has been recorded as deferred revenue and will be recognized as revenue on a straight-line basis over the contractual term of the Agreement. The Company recognized $2,200 revenue related to the Wonik agreement for each of the three months ended June 30, 2016 and 2015. Deferred revenue short-term balance at June 30, 2016 and December 31, 2015 amounted to approximately $9,000 for each period and deferred revenue long-term balances at June 30, 2016 and December 31, 2015 amounted to approximately $24,000 and $29,000, respectively. |
Loss per common share | Basic loss per common share excludes any potential dilution and is computed by dividing net loss by the weighted average number of common shares outstanding during the period. Diluted net loss per common share reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that then shared in the earnings of the entity. However, since their effect is anti-dilutive, the Company has excluded potentially dilutive shares. The following potentially dilutive shares have been excluded from the calculation of diluted net loss per share as their effect would be anti-dilutive. Six Months Ended June 30, 2016 June 30, 2015 Series C non-voting convertible preferred stock 2,865,000 2,865,000 Series D non-voting convertible preferred stock 1,479,240 1,479,240 Series E non-voting convertible preferred stock 1,959,759 1,959,759 Shares underlying outstanding warrants 4,006,468 4,422,188 Shares underlying outstanding stock options 4,134,545 3,594,545 Total 14,445,012 14,320,732 |
Stock-Based Compensation | The Company accounts for stock options granted to employees, officers and directors according to ASC No. 718, Compensation Stock Compensation The Company accounts for stock options granted to non-employees on a fair value basis using the Black-Scholes option pricing model in accordance with ASC 718 and ASC No. 505-50, Equity-Based Payments to Non-Employees Stock compensation expense is recognized by applying the expected forfeiture rate during the vesting period to the fair value of the award. The estimation of the number of stock awards that will ultimately vest requires judgment, and to the extent actual results or updated estimates differ from the Companys current estimates, compensation expense may need to be revised. The Company considers many factors when estimating expected forfeitures for stock awards granted to employees, officers and directors, including types of awards, employee class, and an analysis of historical forfeitures. |
Research and Development | Research and development costs are charged to expense as incurred. Research and development includes fees associated with operational consultants, contract clinical research organizations, contract manufacturing organizations, clinical site fees, contract laboratory research organizations, contract central testing laboratories, licensing activities, and allocated executive, human resources and facilities expenses. The Company accrues for costs incurred as the services are being provided by monitoring the status of the trial and the invoices received from its external service providers. Costs related to the acquisition of technology rights and patents for which development work is still in process are charged to operations as incurred and considered a component of research and development expense. |
2. Summary of Significant Acc14
2. Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Accounting Policies [Abstract] | |
Summary of short-term investments | June 30, 2016: Amortized Cost Gross Unrealized Losses Gross Unrealized Gains Fair Value Money Market Funds included in Cash Equivalents $ 3,521,427 $ - $ - $ 3,521,427 U.S. Government Agency Securities 3,021,439 (190 ) 651 3,021,900 Corporate Securities 11,570,367 (2,185 ) 1,483 11,569,665 Commercial Paper 1,999,279 - - 1,999,279 Subtotal 16,591,085 (2,375 ) 2,134 16,590,844 Total June 30, 2016 $ 20,112,512 $ (2,375 ) $ 2,134 $ 20,112,271 December 31, 2015: Money Market Funds included in Cash Equivalents $ 3,353,067 $ - $ - $ 3,353,067 U.S. Government Agency Securities 6,531,914 (3,014 ) - 6,528,900 Corporate Securities 15,065,595 (21,637 ) 412 15,044,370 Commercial Paper 1,995,116 - - 1,995,116 Subtotal 23,592,625 (24,651 ) 412 23,568,386 Total December 31, 2015 $ 26,945,692 $ (24,651 ) $ 412 $ 26,921,453 |
Carrying and fair value of financial assets | June 30, 2016: Carrying Value Level 1 Level 2 Level 3 Money Market Funds $ 3,521,427 $ 3,521,427 $ - $ - US Government Agency Securities 3,021,900 - 3,021,900 - Corporate Securities 11,569,665 - 11,569,665 - Commercial Paper 1,999,279 - 1,999,279 - Subtotal 16,590,844 - 16,590,844 $ - Total June 30, 2016 $ 20,112,271 $ 3,521,427 $ 16,590,844 $ - December 31, 2015: Money Market Funds $ 3,353,067 $ 3,353,067 $ - $ - US Government Agency Securities 6,528,900 - 6,528,900 - Corporate Securities 15,044,370 - 15,044,370 - Commercial Paper 1,995,116 - 1,995,116 - Subtotal 23,568,386 - 23,568,386 $ - Total December 31, 2015 $ 26,921,453 $ 3,353,067 $ 23,568,386 $ - |
Schedule of inventories | June 30, 2016 December 31, 2015 Raw materials $ 221,355 $ 244,459 Work in process 355,297 424,622 Finished goods 46,848 7,488 Inventory reserve (466,000 ) (300,000 ) Total $ 157,500 $ 376,569 |
Schedule of accrued expenses | June 30, 2016 December 31, 2015 Professional and consulting fees $ 240,833 $ 282,975 Accrued payroll and payroll taxes 703,224 532,084 Clinical trial and manufacturing development 853,150 226,042 Monitoring program fees 40,207 65,076 Statutory taxes 963 67,236 Other 38,294 48,144 Total $ 1,876,671 $ 1,221,557 |
Schedule of anti-dilutive securities excluded from calculation of diluted net loss per share | Six Months Ended June 30, 2016 June 30, 2015 Series C non-voting convertible preferred stock 2,865,000 2,865,000 Series D non-voting convertible preferred stock 1,479,240 1,479,240 Series E non-voting convertible preferred stock 1,959,759 1,959,759 Shares underlying outstanding warrants 4,006,468 4,422,188 Shares underlying outstanding stock options 4,134,545 3,594,545 Total 14,445,012 14,320,732 |
3. Stockholders' Equity (Tables
3. Stockholders' Equity (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Fair value assumptions for Black Sholes | Six Months Ended June 30, 2016 Expected Term 5 -10 years Volatility 96% - 98% Dividend yield 0.0% Risk-free interest rate 1.25% - 1.94% |
Summary of Option Activity under Plan and Related Information | Shares Weighted Average Exercise Price Outstanding at beginning of period 3,600,045 $ 1.82 Exercised (500,000 ) $ 0.82 Forfeited (156,500 ) $ 2.03 Expired - - Granted 1,041,000 $ 2.14 Outstanding at end of period 3,984,545 $ 2.02 Options exercisable 3,047,123 $ 1.95 Weighted-average fair value of options granted during the period $ 1.64 Weighted average remaining contractual life of stock options outstanding (years) 6.3 Weighted average remaining contractual life of stock options exercisable (years) 5.2 Weighted average vesting period over which total compensation expense related to non-vested options not yet recognized (years) 1.1 Compensation expense related to non-vested options not yet recognized $ 1,193,963 Aggregate intrinsic value of stock options exercised $ 980,039 Aggregate intrinsic value of stock options outstanding $ 1,783,259 |
Summary of Warrant Activity | Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life Outstanding at beginning of period 4,422,188 $ 1.80 3.07 Granted - - - Expired (390,720 ) $ 3.44 - Exercised (25,000 ) $ 0.40 - Outstanding at end of period 4,006,468 $ 1.65 2.86 |
5. Commitments and Contingenc16
5. Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Rental Payments for Operating Leases | 2017 $ 62,053 2018 45,157 Total $ 107,210 |
2. Summary of Significant Acc17
2. Summary of Significant Accounting Policies (Details) - USD ($) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2016 | Dec. 31, 2015 | |
Amortized cost | $ 20,112,512 | $ 26,945,692 |
Gross unrealized losses | (2,375) | (24,651) |
Gross unrealized gains | 2,134 | 412 |
Fair value | 20,112,271 | 26,921,453 |
Money Market Funds included in Cash Equivalents | ||
Amortized cost | 3,521,427 | 3,353,067 |
Gross unrealized losses | 0 | 0 |
Gross unrealized gains | 0 | 0 |
Fair value | 3,521,427 | 3,353,067 |
U.S. Government Agency Securities | ||
Amortized cost | 3,021,439 | 6,531,914 |
Gross unrealized losses | (190) | (3,014) |
Gross unrealized gains | 651 | 0 |
Fair value | 3,021,900 | 6,528,900 |
Corporate Securities | ||
Amortized cost | 11,570,367 | 15,065,595 |
Gross unrealized losses | (2,185) | (21,637) |
Gross unrealized gains | 1,483 | 412 |
Fair value | 11,569,665 | 15,044,370 |
Commercial Paper | ||
Amortized cost | 1,999,279 | 1,995,116 |
Gross unrealized losses | 0 | 0 |
Gross unrealized gains | 0 | 0 |
Fair value | 1,999,279 | 1,995,116 |
Subtotal | ||
Amortized cost | 16,591,085 | 23,592,625 |
Gross unrealized losses | (2,375) | (24,651) |
Gross unrealized gains | 2,134 | 412 |
Fair value | $ 16,590,844 | $ 23,568,386 |
2. Summary of Significant Acc18
2. Summary of Significant Accounting Policies (Details 1) - USD ($) | Jun. 30, 2016 | Dec. 31, 2015 |
Carrying Value | $ 20,112,271 | $ 26,921,453 |
Level 1 | ||
Carrying Value | 3,521,427 | 3,353,067 |
Level 2 | ||
Carrying Value | 16,590,844 | 23,568,386 |
Level 3 | ||
Carrying Value | 0 | 0 |
Money Market Funds included in Cash Equivalents | ||
Carrying Value | 3,521,427 | 3,353,067 |
Money Market Funds included in Cash Equivalents | Level 1 | ||
Carrying Value | 3,521,427 | 3,353,067 |
Money Market Funds included in Cash Equivalents | Level 2 | ||
Carrying Value | 0 | 0 |
Money Market Funds included in Cash Equivalents | Level 3 | ||
Carrying Value | 0 | 0 |
U.S. Government Agency Securities | ||
Carrying Value | 3,021,900 | 6,528,900 |
U.S. Government Agency Securities | Level 1 | ||
Carrying Value | 0 | 0 |
U.S. Government Agency Securities | Level 2 | ||
Carrying Value | 3,021,900 | 6,528,900 |
U.S. Government Agency Securities | Level 3 | ||
Carrying Value | 0 | 0 |
Corporate Securities | ||
Carrying Value | 11,569,665 | 15,044,370 |
Corporate Securities | Level 1 | ||
Carrying Value | 0 | 0 |
Corporate Securities | Level 2 | ||
Carrying Value | 11,569,665 | 15,044,370 |
Corporate Securities | Level 3 | ||
Carrying Value | 0 | 0 |
Commercial Paper | ||
Carrying Value | 1,999,279 | 1,995,116 |
Commercial Paper | Level 1 | ||
Carrying Value | 0 | 0 |
Commercial Paper | Level 2 | ||
Carrying Value | 1,999,279 | 1,995,116 |
Commercial Paper | Level 3 | ||
Carrying Value | 0 | 0 |
Subtotal | ||
Carrying Value | 16,590,844 | 23,568,386 |
Subtotal | Level 1 | ||
Carrying Value | 0 | 0 |
Subtotal | Level 2 | ||
Carrying Value | 16,590,844 | 23,568,386 |
Subtotal | Level 3 | ||
Carrying Value | $ 0 | $ 0 |
2. Summary of Significant Acc19
2. Summary of Significant Accounting Policies (Details 2) - USD ($) | Jun. 30, 2016 | Dec. 31, 2015 |
Summary Of Significant Accounting Policies Details 2 | ||
Raw materials | $ 221,355 | $ 244,459 |
Work in process | 355,297 | 424,622 |
Finished goods | 46,848 | 7,488 |
Inventory reserve | (466,000) | (300,000) |
Total | $ 157,500 | $ 376,569 |
2. Summary of Significant Acc20
2. Summary of Significant Accounting Policies (Details 3) - USD ($) | Jun. 30, 2016 | Dec. 31, 2015 |
Accounting Policies [Abstract] | ||
Professional and consulting fees | $ 240,833 | $ 282,975 |
Accrued payroll and payroll taxes | 703,224 | 532,084 |
Clinical trial and manufacturing development | 853,150 | 226,042 |
Monitoring program fees | 40,207 | 65,076 |
Statutory taxes | 963 | 67,236 |
Other | 38,294 | 48,144 |
Total | $ 1,876,671 | $ 1,221,557 |
2. Summary of Significant Acc21
2. Summary of Significant Accounting Policies (Details 4) - shares | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Antidilutive Shares | 14,445,012 | 14,320,732 |
Series C non-voting convertible preferred stock | ||
Antidilutive Shares | 2,865,000 | 2,865,000 |
Series D non-voting convertible preferred stock | ||
Antidilutive Shares | 1,479,240 | 1,479,240 |
Series E non-voting convertible preferred stock | ||
Antidilutive Shares | 1,959,759 | 1,959,759 |
Warrants | ||
Antidilutive Shares | 4,006,468 | 4,422,188 |
Shares underlying outstanding stock options | ||
Antidilutive Shares | 4,134,545 | 3,594,545 |
2. Summary of Significant Acc22
2. Summary of Significant Accounting Policies (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | Dec. 31, 2015 | |
Accounting Policies [Abstract] | |||||
Accumulated deficit | $ (103,509,607) | $ (103,509,607) | $ (94,391,595) | ||
Loss from operations | $ 4,912,220 | $ 4,134,589 | $ 9,173,549 | $ 8,048,262 |
3. Stockholders' Equity (Detail
3. Stockholders' Equity (Details) - Stock options | 6 Months Ended |
Jun. 30, 2016$ / shares | |
Expected Term, minimum | 5 years |
Expected Term, maximum | 10 years |
Volatility, minimum | 96.00% |
Volatility, maximum | 98.00% |
Dividend yield | 0.00% |
Risk-free interest rate, minimum | 1.25% |
Risk-free interest rate, maximum | 1.94% |
Weighted-average fair value of options granted during the period | $ 1.64 |
3. Stockholders' Equity (Deta24
3. Stockholders' Equity (Details 1) - Stock options | 6 Months Ended |
Jun. 30, 2016USD ($)$ / sharesshares | |
Number of Options | |
Outstanding at beginning of period | shares | 3,600,045 |
Number of Options Exercised | shares | (500,000) |
Number of Options Forfeited | shares | (156,500) |
Number of Options Expired | shares | 0 |
Number of Options Granted | shares | 1,041,000 |
Outstanding at end of period | shares | 3,984,545 |
Options exercisable | shares | 3,047,123 |
Weighted Average Exercise Price | |
Weighted Average Exercise Price Outstanding, Beginning | $ 1.82 |
Weighted Average Exercise Price Exercised | .82 |
Weighted Average Exercise Price Forfeited | 2.03 |
Weighted Average Exercise Price Expired | 0 |
Weighted Average Exercise Price Granted | 2.14 |
Weighted Average Exercise Price Outstanding, Ending | 2.02 |
Weighted Average Exercise Price Exercisable | 1.95 |
Weighted-average fair value of options granted during the period | $ 1.64 |
Weighted Average Remaining Contractual Life (in years) | |
Weighted Average Remaining Contractual Life (in years) Outstanding, Ending | 6 years 3 months 18 days |
Weighted Average Remaining Contractual Life (in years) Exercisable | 5 years 2 months 12 days |
Weighted average vesting period over which total compensation expense related to non-vested options not yet recognized (years) | 1 year 1 month 6 days |
Aggregate Intrinsic Value | |
Compensation expense related to non-vested options not yet recognized | $ | $ 1,193,963 |
Aggregate intrinsic value of stock options exercised | $ | 980,039 |
Aggregate intrinsic value of stock options outstanding | $ | $ 1,783,259 |
3. Stockholders' Equity (Deta25
3. Stockholders' Equity (Details 2) - Warrants | 6 Months Ended |
Jun. 30, 2016$ / sharesshares | |
Outstanding at beginning of period | shares | 4,422,188 |
Number of Warrants Granted | shares | 0 |
Number of Warrants Expired | shares | (390,720) |
Number of Warrants Exercised | shares | (25,000) |
Outstanding at end of period | shares | 4,006,468 |
Weighted Average Exercise Price Outstanding, Beginning | $ / shares | $ 1.80 |
Weighted Average Exercise Price Granted | $ / shares | 0 |
Weighted Average Exercise Price Expired | $ / shares | 3.44 |
Weighted Average Exercise Price Exercised | $ / shares | .40 |
Weighted Average Exercise Price Outstanding, Ending | $ / shares | $ 1.65 |
Weighted Average Remaining Contractual Life (in years) Outstanding, Beginning | 3 years 25 days |
Weighted Average Remaining Contractual Life (in years) Outstanding, Ending | 2 years 10 months 10 days |
5. Commitments and Contingenc26
5. Commitments and Contingencies (Details) | Jun. 30, 2016USD ($) |
Commitments And Contingencies Details | |
2,017 | $ 62,053 |
2,018 | 45,157 |
Total | $ 107,210 |