Document_and_Entity_Informatio
Document and Entity Information (USD $) | 12 Months Ended | ||
In Millions, except Share data, unless otherwise specified | Dec. 31, 2012 | Mar. 25, 2013 | Jun. 30, 2012 |
Document Documentand Entity Information [Abstract] | ' | ' | ' |
Document Type | '10-K | ' | ' |
Amendment Flag | 'true | ' | ' |
Amendment Description | 'This amendment is being filed to comply with regulations. | ' | ' |
Document Period End Date | 31-Dec-12 | ' | ' |
Document Fiscal Year Focus | '2012 | ' | ' |
Document Fiscal Period Focus | 'FY | ' | ' |
Trading Symbol | 'CRMD | ' | ' |
Entity Registrant Name | 'CorMedix Inc. | ' | ' |
Entity Central Index Key | '0001410098 | ' | ' |
Current Fiscal Year End Date | '--12-31 | ' | ' |
Entity Well Known Seasoned Issuer | 'No | ' | ' |
Entity Current Reporting Status | 'Yes | ' | ' |
Entity Voluntary Filers | 'No | ' | ' |
Entity Filer Category | 'Smaller Reporting Company | ' | ' |
Entity Common Stock, Shares Outstanding | ' | 11,882,379 | ' |
Entity Public Float | ' | ' | $2.30 |
BALANCE_SHEETS
BALANCE SHEETS (USD $) | Dec. 31, 2012 | Dec. 31, 2011 |
Current assets | ' | ' |
Cash and cash equivalents | $835,471 | $1,985,334 |
Prepaid research and development expenses | 11,221 | 19,888 |
Deferred financing costs | 257,886 | ' |
Other receivable | ' | 493,855 |
Other prepaid expenses and current assets | 30,677 | 31,897 |
Total current assets | 1,135,255 | 2,530,974 |
Property and equipment, net | 4,668 | 11,689 |
Security deposit | 13,342 | 13,342 |
TOTAL ASSETS | 1,153,265 | 2,556,005 |
Current liabilities | ' | ' |
Accounts payable | 928,553 | 913,493 |
Accrued expenses | 261,983 | 296,512 |
Accrued interest, related parties | 16,175 | ' |
Senior convertible notes, net of debt discount of $647,939 | 16,061 | ' |
Senior convertible notes - related parties, net of debt discount of $406,316 | 253,684 | ' |
Total current liabilities | 1,476,456 | 1,210,005 |
Deferred rent | 12,185 | 14,472 |
TOTAL LIABILITIES | 1,488,641 | 1,224,477 |
STOCKHOLDERS' EQUITY (DEFICIENCY) | ' | ' |
Preferred stock - $0.001 par value: 2,000,000 shares authorized in 2012, none issued and outstanding | ' | ' |
Common stock - $0.001 par value: 80,000,000 and 40,000,000 shares authorized in 2012 and 2011, respectively; 11,408,274 shares issued and outstanding at December 31, 2012 and 2011 | 11,408 | 11,408 |
Deferred stock issuances | -146 | -146 |
Additional paid-in capital | 45,886,596 | 44,172,818 |
Deficit accumulated during the development stage | -46,233,234 | -42,852,552 |
TOTAL STOCKHOLDERS' EQUITY (DEFICIENCY) | -335,376 | 1,331,528 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIENCY) | $1,153,265 | $2,556,005 |
BALANCE_SHEETS_Parenthetical
BALANCE SHEETS (Parenthetical) (USD $) | Dec. 31, 2012 | Dec. 31, 2011 |
In Thousands, except Share data, unless otherwise specified | ||
Statement of Financial Position [Abstract] | ' | ' |
Preferred Stock, par value | $0.00 | $0.00 |
Preferred stock, shares authorized | 2,000,000 | ' |
Common stock, par value | $0.00 | $0.00 |
Common stock, shares authorized | 80,000,000 | 40,000,000 |
Common stock, shares issued | 11,408,274 | 11,408,274 |
Common stock, shares outstanding | 11,408,274 | 11,408,274 |
Convertible Debt Discount | $647,939 | ' |
Convertible debt discount, related parties | $406,316 | ' |
STATEMENTS_OF_OPERATIONS
STATEMENTS OF OPERATIONS (USD $) | 12 Months Ended | 77 Months Ended | |
Dec. 31, 2012 | Dec. 31, 2011 | Dec. 31, 2012 | |
OPERATING EXPENSES | ' | ' | ' |
Research and development | $1,142,631 | $4,058,225 | $23,203,305 |
General and administrative | 1,857,080 | 3,148,759 | 12,776,034 |
Total operating expenses | 2,999,711 | 7,206,984 | 35,979,339 |
LOSS FROM OPERATIONS | -2,999,711 | -7,206,984 | -35,979,339 |
OTHER INCOME (EXPENSE) | ' | ' | ' |
Other income | ' | 29,819 | 420,987 |
Interest income | 1,965 | 12,037 | 126,307 |
Interest expense, including amortization and write-off of deferred financing costs and debt discounts | -382,936 | ' | -11,575,964 |
LOSS BEFORE INCOME TAXES | -3,380,682 | -7,165,128 | -47,008,009 |
State income tax benefit | ' | 493,855 | 774,775 |
NET LOSS | ($3,380,682) | ($6,671,273) | ($46,233,234) |
NET LOSS PER COMMON SHARE - BASIC AND DILUTED | ($0.30) | ($0.58) | ' |
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING - BASIC AND DILUTED | 11,408,274 | 11,408,274 | ' |
STATEMENTS_OF_CASH_FLOWS
STATEMENTS OF CASH FLOWS (USD $) | 12 Months Ended | 77 Months Ended | |
Dec. 31, 2012 | Dec. 31, 2011 | Dec. 31, 2012 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ' | ' | ' |
Net loss | ($3,380,682) | ($6,671,273) | ($46,233,234) |
Adjustments to reconcile net loss to net cash used in operating activities: | ' | ' | ' |
Stock-based compensation | 274,358 | 692,403 | 2,599,238 |
Stock issued in connection with license agreements | ' | ' | 6,613,718 |
Stock issued in connection with consulting agreement | ' | ' | 158,262 |
Amortization of deferred financing costs | 76,632 | ' | 2,124,513 |
Amortization of debt discount | 279,052 | ' | 5,258,513 |
Non-cash charge for beneficial conversion feature | ' | ' | 1,137,762 |
Non-cash interest expense | ' | ' | 3,007,018 |
Expenses paid on behalf of the Company satisfied through the issuance of notes | ' | ' | 51,253 |
Depreciation | 7,022 | 12,246 | 57,042 |
Changes in operating assets and liabilities: | ' | ' | ' |
Prepaid expenses and other current assets | 503,742 | -17,176 | -41,898 |
Security deposits | ' | ' | -13,342 |
Accounts payable | -15,743 | -170,783 | 897,750 |
Accrued expenses and accrued interest | -18,354 | -139,855 | 278,158 |
Deferred rent | -2,287 | -2,287 | 12,185 |
Net cash used in operating activities | -2,276,260 | -6,296,725 | -24,093,062 |
CASH FLOWS FROM INVESTING ACTIVITIES: | ' | ' | ' |
Purchase of equipment | ' | -1,625 | -61,709 |
Net cash used in investing activities | ' | -1,625 | -61,709 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ' | ' | ' |
Proceeds from notes payable to related parties, net | 597,735 | ' | 3,063,484 |
Proceeds from senior convertible notes, net | 598,865 | ' | 13,963,838 |
Proceeds from Galenica, Ltd. promissory note | ' | ' | 1,000,000 |
Payment of deferred financing costs | 70,203 | ' | 1,517,603 |
Repayment of amounts loaned under related party notes | ' | ' | -1,981,574 |
Proceeds from sale of equity securities, net of issuance costs | ' | ' | 10,457,270 |
Proceeds from receipt of stock subscriptions and issuances of common stock | ' | ' | 4,827 |
Net cash provided by financing activities | 1,126,397 | ' | 24,990,242 |
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | -1,149,863 | -6,298,350 | 835,471 |
CASH AND CASH EQUIVALENTS - BEGINNING OF PERIOD | 1,985,334 | 8,283,684 | ' |
CASH AND CASH EQUIVALENTS - END OF PERIOD | 835,471 | 1,985,334 | 835,471 |
Cash paid for interest | ' | ' | 18,425 |
Supplemental Disclosure of Non Cash Financing Activities: | ' | ' | ' |
Conversion of notes payable and accrued interest to common stock | ' | ' | 18,897,167 |
Reclassification of deferred financing fees to additional paid-in capital | ' | ' | 148,015 |
Stock issued to technology finders and licensors | ' | ' | 155 |
Warrants issued to placement agent | 106,113 | ' | 854,608 |
Debt discount on senior convertible notes | 1,333,307 | ' | 6,312,768 |
Accrued deferred financing costs | $30,803 | ' | $30,803 |
STATEMENTS_OF_CHANGES_IN_STOCK
STATEMENTS OF CHANGES IN STOCKHOLDERSb EQUITY (DEFICIENCY) (USD $) | Common Stock | Non-Voting Common Stock B Class A | Common Stock B Series B - F | Deferred Stock Issuances | Additional Paid-In Capital | Deficit Accumulated During the Development Stage Restated | Total Stockholders Equity Deficiency Restated |
Balance Beginning, Amount at Jul. 27, 2006 | ' | ' | ' | ' | ' | ' | ' |
Common stock issued to founders at $0.008 per share in July 2006, Shares | 510,503 | ' | ' | ' | ' | ' | ' |
Common stock issued to founders at $0.008 per share in July 2006, Amount | $510 | ' | ' | ' | $3,490 | ' | $4,000 |
Common stock issued and held in escrow to licensor at $0.008 per share in August 2006, Shares | ' | ' | 1,000,000 | ' | ' | ' | ' |
Common stock issued and held in escrow to licensor at $0.008 per share in August 2006, Amount | ' | ' | 1,000 | -1,000 | ' | ' | ' |
Common stock issued to employee at $0.008 per share in November 2006, Shares | 53,743 | ' | ' | ' | ' | ' | ' |
Common stock issued to employee at $0.008 per share in November 2006, Amount | 54 | ' | ' | ' | 367 | ' | 421 |
Stock-based compensation | ' | ' | ' | ' | 4,726 | ' | 4,726 |
Net loss | ' | ' | ' | ' | ' | -975,317 | -975,317 |
Balance Ending, Amount at Dec. 31, 2006 | 27 | ' | 1,000 | -1,000 | 8,583 | -975,317 | -966,170 |
Balance Ending, Shares at Dec. 31, 2006 | 564,246 | ' | 1,000,000 | ' | ' | ' | ' |
Common stock issued to employees at $0.008 per share in January and March 2007, Shares | 27,056 | ' | ' | ' | ' | ' | ' |
Common stock issued to employees at $0.008 per share in January and March 2007, Amount | 27 | ' | ' | ' | 185 | ' | 212 |
Common stock issued to technology finders at $0.008 per share in March 2007, Shares | ' | 193,936 | ' | ' | ' | ' | ' |
Common stock issued to technology finders at $0.008 per share in March 2007, Amount | ' | 194 | ' | ' | ' | ' | 194 |
Warrants issued in connection with senior convertible notes | ' | ' | ' | ' | 748,495 | ' | 748,495 |
Debt discount on senior convertible notes | ' | ' | ' | ' | 2,993,981 | ' | 2,993,981 |
Stock-based compensation | ' | ' | ' | ' | 64,875 | ' | 64,875 |
Net loss | ' | ' | ' | ' | ' | -7,237,526 | -7,237,526 |
Balance Ending, Amount at Dec. 31, 2007 | 591 | 194 | 1,000 | -1,000 | 3,816,119 | -8,212,843 | -4,395,939 |
Balance Ending, Shares at Dec. 31, 2007 | 591,302 | 193,936 | 1,000,000 | ' | ' | ' | ' |
Common stock issued to licensor at $8.23 per share in January 2008, Shares | 39,980 | ' | ' | ' | ' | ' | ' |
Common stock issued to licensor at $8.23 per share in January 2008, Amount | 40 | ' | ' | ' | 328,908 | ' | 328,948 |
Common stock issued to licensor and held in escrow in January 2008, Shares | 15,992 | ' | ' | ' | ' | ' | ' |
Common stock issued to licensor and held in escrow in January 2008, Amount | 16 | ' | ' | -125 | 109 | ' | ' |
Common stock issued to consultant at $8.23 per share in May 2008, Shares | 939 | ' | ' | ' | ' | ' | ' |
Common stock issued to consultant at $8.23 per share in May 2008, Amount | 1 | ' | ' | ' | 7,720 | ' | 7,721 |
Debt discount on senior convertible notes | ' | ' | ' | ' | 747,215 | ' | 747,215 |
Stock-based compensation | ' | ' | ' | ' | 281,652 | ' | 281,652 |
Net loss | ' | ' | ' | ' | ' | -8,996,745 | -8,996,745 |
Balance Ending, Amount at Dec. 31, 2008 | 648 | 194 | 1,000,000 | -1,125 | 5,181,723 | -17,209,588 | -12,027,148 |
Balance Ending, Shares at Dec. 31, 2008 | 648,213 | 193,936 | 1,000,000 | ' | ' | ' | ' |
Common stock issued to consultant at $32.05 per share in July 2009, Shares | 639 | ' | ' | ' | ' | ' | ' |
Common stock issued to consultant at $32.05 per share in July 2009, Amount | 1 | ' | ' | ' | 20,449 | ' | 20,450 |
Common stock issued to licensor at $32.05 per share in exchange for Series B-F common stock in October 2009, Shares | 98,739 | ' | -1,000,000 | ' | ' | ' | ' |
Common stock issued to licensor at $32.05 per share in exchange for Series B-F common stock in October 2009, Amount | 99 | ' | -1,000 | 1,186 | 3,164,217 | ' | 3,164,502 |
Common stock issued to licensor at $32.05 per share in October 2009, Shares | 28,156 | ' | ' | ' | ' | ' | ' |
Common stock issued to licensor at $32.05 per share in October 2009, Amount | 28 | ' | ' | ' | 902,316 | ' | 902,344 |
Common stock issued to licensor and held in escrow in October 2009, Shares | 11,263 | ' | ' | ' | ' | ' | ' |
Common stock issued to licensor and held in escrow in October 2009, Amount | 11 | ' | ' | -88 | 77 | ' | ' |
Debt discount on senior convertible notes | ' | ' | ' | ' | 1,238,265 | ' | 1,238,265 |
Stock-based compensation | ' | ' | ' | ' | 114,143 | ' | 114,143 |
Net loss | ' | ' | ' | ' | ' | -8,096,455 | -8,096,455 |
Balance Ending, Amount at Dec. 31, 2009 | 787 | 194 | ' | -27 | 10,621,190 | -25,306,043 | -14,683,899 |
Balance Ending, Shares at Dec. 31, 2009 | 787,010 | 193,936 | ' | ' | ' | ' | ' |
Common stock issued to consultant at $32.05 per share in February 2010, Shares | 4,059 | ' | ' | ' | ' | ' | ' |
Common stock issued to consultant at $32.05 per share in February 2010, Amount | 4 | ' | ' | ' | 130,087 | ' | 130,091 |
Common stock issued upon conversion of Class A Non-Voting Common Stock at a 1 for 7.836 conversion rate in February 2010, Shares | 24,750 | -193,936 | ' | ' | ' | ' | ' |
Common stock issued upon conversion of Class A Non-Voting Common Stock at a 1 for 7.836 conversion rate in February 2010, Amount | 25 | -194 | ' | ' | 169 | ' | ' |
Common stock issued from debt conversion to noteholders in March 2010, Shares | 5,914,431 | ' | ' | ' | ' | ' | ' |
Common stock issued from debt conversion to noteholders in March 2010, Amount | 5,914 | ' | ' | ' | 18,891,253 | ' | 18,897,167 |
Common stock issued to licensors at $3.125 per share in March 2010, Shares | 828,024 | ' | ' | ' | ' | ' | ' |
Common stock issued to licensors at $3.125 per share in March 2010, Amount | 828 | ' | ' | -119 | 2,217,215 | ' | 2,217,924 |
Common stock issued in initial public offering at $3.125 per share in March 2010, net of issuance costs, Shares | 3,850,000 | ' | ' | ' | ' | ' | ' |
Common stock issued in initial public offering at $3.125 per share in March 2010, net of issuance costs, Amount | 3,850 | ' | ' | ' | 10,453,420 | ' | 10,457,270 |
Stock-based compensation | ' | ' | ' | ' | 1,167,081 | ' | 1,167,081 |
Net loss | ' | ' | ' | ' | ' | -10,875,236 | -10,875,236 |
Balance Ending, Amount at Dec. 31, 2010 | 11,408 | ' | ' | -146 | 43,480,415 | -36,181,279 | 7,310,398 |
Balance Ending, Shares at Dec. 31, 2010 | 11,408,274 | ' | ' | ' | ' | ' | ' |
Stock-based compensation | ' | ' | ' | ' | 692,403 | ' | 692,403 |
Net loss | ' | ' | ' | ' | ' | -6,671,273 | -6,671,273 |
Balance Ending, Amount at Dec. 31, 2011 | 11,408 | ' | ' | -146 | 44,172,818 | -42,852,552 | 1,331,528 |
Balance Ending, Shares at Dec. 31, 2011 | 11,408,274 | ' | ' | ' | ' | ' | ' |
Warrants issued to placement agent in connection with financing | ' | ' | ' | ' | 106,113 | ' | 106,113 |
Debt discount on senior convertible notes | ' | ' | ' | ' | 1,333,307 | ' | 1,333,307 |
Stock-based compensation | ' | ' | ' | ' | 274,358 | ' | 274,358 |
Net loss | ' | ' | ' | ' | ' | -3,380,682 | -3,380,682 |
Balance Ending, Amount at Dec. 31, 2012 | $11,408 | ' | ' | ($146) | $45,886,596 | ($46,233,234) | ($335,376) |
Balance Ending, Shares at Dec. 31, 2012 | 11,408,274 | ' | ' | ' | ' | ' | ' |
1_Organization_Business_and_Ba
1. Organization, Business and Basis of Presentation | 12 Months Ended |
Dec. 31, 2012 | |
Organization Business And Basis Of Presentation | ' |
Organization, Business and Basis of Presentation | ' |
Organization and Business: | |
CorMedix Inc. (f/k/a Picton Holding Company, Inc.) (“CorMedix” or the “Company”) was incorporated in the State of Delaware on July 28, 2006. CorMedix is a development stage pharmaceutical and medical device company that seeks to fulfill selected, significant medical needs in the preventive areas of catheter related infections in dialysis and non-dialysis catheters. On January 18, 2007, the Company changed its name from Picton Holding Company, Inc. to CorMedix Inc. | |
Basis of Presentation: | |
The Company’s primary activities since incorporation have been organizational activities, including recruiting personnel, establishing office facilities, acquiring licenses for its pharmaceutical product candidates, performing business and financial planning, performing research and development and raising funds through the issuance of debt and equity securities. The Company has not generated any revenues and, accordingly, the Company is considered to be in the development stage. | |
The Company’s financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the settlement of liabilities and commitments through the normal course of business. For the year ended December 31, 2012 and the period from July 28, 2006 (inception) to December 31, 2012, the Company incurred net losses of $3,380,682 and $46,233,234, respectively. The Company has stockholders’ deficit as of December 31, 2012 of $335,376. Management believes that the Company will continue to incur losses for the foreseeable future and will need additional equity or debt financing or will need to generate revenue from the licensing or distribution of its products or by entering into strategic alliances to be able to sustain its operations until it can achieve profitability and positive cash flows, if ever. Management believes that the Company’s decision to focus the majority of the Company’s resources, including the Company’s research and development efforts, primarily on the CE Marking approval and commercialization of Neutrolin® (CRMD003) in Europe will result in the currently available capital resources of the Company being sufficient to meet the Company’s operating needs into the second quarter of 2013, after giving effect to the Company’s gross receipt of $1,324,000 from the Company’s convertible note financing during the year ended December 31, 2012 and the gross proceeds of $533,000 from the private placement of Series A non-voting convertible preferred stock in February 2013 (see Note 11). The Company intends to raise additional funds through various potential sources, such as equity and/or debt financings, strategic relationships, or out-licensing of its products, however, the Company can provide no assurances that such financing or strategic relationships will be available on acceptable terms, or at all. If adequate financing or a strategic relationship is not available, the Company may be required to terminate or significantly curtail or cease its operations, or enter into arrangements with collaborative partners or others that may require the Company to relinquish rights to certain of its technologies, or potential markets that the Company would not otherwise relinquish. If the Company is unable to achieve these goals, its business would be jeopardized and it may not be able to continue operations. | |
These matters, among others, raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying financial statements do not include any adjustments that might result from the outcome of this uncertainty. | |
On February 24, 2010, the Company effected a 1 for 7.836 reverse stock split of its common stock. All share and per-share information in these financial statements have been adjusted to give effect to the reverse stock split. | |
2_Summary_of_Significant_Accou
2. Summary of Significant Accounting Policies | 12 Months Ended | ||||
Dec. 31, 2012 | |||||
Accounting Policies [Abstract] | ' | ||||
Summary of Significant Accounting Policies | ' | ||||
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 deposit and other interest bearing accounts, the balances of which, at times, may exceed Federally insured limits. | |||||
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. | |||||
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. | |||||
Property and Equipment: | |||||
Property and equipment consist primarily of furnishings, fixtures, leasehold improvements, office equipment and computer equipment which are recorded at cost. Repairs and maintenance costs are expensed in the period incurred. Depreciation of property and equipment 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, net as of December 31, 2012 and 2011 were $4,668 and $11,689, respectively, net of accumulated depreciation of $57,042, and $50,020, respectively. | |||||
Description | Estimated Useful Life | ||||
Office equipment and furniture | 5 years | ||||
Leasehold improvements | 5 years | ||||
Computer equipment | 5 years | ||||
Computer software | 3 years | ||||
Stock-Based Compensation: | |||||
The Company accounts for stock options granted to employees according to the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) No. 718 (“ASC 718”), “Compensation — Stock Compensation”. Under ASC 718, share-based compensation cost is measured at the grant date, based on the estimated fair value of the award, and is recognized as expense over the employee’s requisite service period on a straight-line basis. | |||||
The Company accounts for stock options granted to non-employees on a fair value basis using the Black-Scholes option pricing method in accordance with ASC 718. The initial noncash charge to operations for non-employee options with service vesting are revalued at the end of each reporting period based upon the change in the fair value of the options and amortized to expense over the related vesting period. For stock options granted to non-employees with vesting contingent upon various performance metrics, the Company used the guidelines in accordance with FASB ASC No. 505-50 (“ASC 505”), “Equity-Based Payments to Non-Employees”, of which if the performance condition is outside of the control of the non-employee, the cost to be recognized is the lowest aggregate fair value prior to the achievement of the performance condition, even if the Company believes it is probable that the performance condition will be achieved. As of December 31, 2012, the performance conditions of such stock options were not achieved; therefore, no non-employee stock options vested and no expense was recorded during the year ended December 31, 2012. For the purpose of valuing performance based options granted to a non-employee during the year ended December 31, 2011, the Company used the standard Monte Carlo stock price simulation method. To estimate the number of stock options expected to vest, the Company used the Monte Carlo stock price simulation method. The Monte Carlo analysis uses several random simulations along with performance vesting metrics, an initial stock price of $1.72, expected volatility of 100% for the one-year period of the vesting contingency and a one-year risk-free rate of 0.25%. The Company then used the results of the Monte Carlo analysis together with the Black-Scholes option pricing model to estimate the fair value of the options issued. 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 our awards. The Company estimated the expected term of the options granted based on anticipated exercises in future periods assuming the success of the Company’s business model as currently forecasted. | |||||
For the purpose of valuing options and warrants granted during the year ended December 31, 2012, the Company used the Black-Scholes option pricing model. The Company estimated the expected term of the stock options granted based on anticipated exercises in future periods assuming the success of its business model as currently forecasted for employees, officers and directors. The expected dividend yield of 0.0% reflects the Company’s current and expected future policy for dividends on the Company’s common stock. To determine the risk-free interest rate, the Company utilized the U.S. Treasury yield curve in effect at the time of grant with a term consistent with the expected term of the Company’s awards. The expected stock price volatility for the stock options was calculated by examining historical volatilities for publicly traded industry peers, since the Company does not have a significant trading history for its common stock. The Company will continue to analyze the expected stock price volatility and expected term assumptions as more historical data for its common stock becomes available. The Company has experienced forfeitures of stock options issued to its former employees, officers, directors and board members. Since the stock options currently outstanding are primarily held by the Company’s senior management and directors, the Company will continue to evaluate the effects of such future potential forfeitures, as they may arise, to ascertain an estimated forfeiture rate. | |||||
2012 | 2011 | ||||
Risk-free interest rate | 0.27% – 1.6% | 0.9% – 2.1% | |||
Expected volatility | 98% – 127% | 109% – 115% | |||
Expected life of options in years | 5 | 5 | |||
Expected dividend yield | 0.00% | 0.00% | |||
Research and Development: | |||||
Research and development costs are charged to expense as incurred. Research and development includes fees associated with operational consultants, contract clinical research organizations, contract manufacturing organizations, clinical site fees, contract laboratory research organizations, contract central testing laboratories, licensing activities, and allocated executive, human resources and facilities expenses. The Company accrues for costs incurred as the services are being provided by monitoring the status of the trial and the invoices received from its external service providers. As actual costs become known, the Company adjusts its accruals in the period when actual costs become known. Costs related to the acquisition of technology rights and patents for which development work is still in process are charged to operations as incurred and considered a component of research and development expense. | |||||
Income Taxes: | |||||
Under ASC 740, “Income Taxes” (“ASC 740”), 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. Under ASC 740, 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. | |||||
Loss Per Common Share: | |||||
Basic earnings (loss) per common share excludes dilution and is computed by dividing net income (loss) by the weighted average number of common shares outstanding during the period. Diluted earnings per common share reflect 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. Since the Company has only incurred losses, basic and diluted loss per share are the same. The amount of potentially dilutive securities excluded from the calculation was 14,367,021 and 6,043,876 shares of common stock underlying warrants, convertible notes and options at December 31, 2012 and 2011, respectively. Additionally, there were 145,543 shares of common stock being held in escrow at December 31, 2012 and 2011, pending the achievement of certain regulatory and sales-based milestones as part of the license agreement with ND Partners LLC. | |||||
Accounting Standards Updates: | |||||
ASUs not effective until after December 31, 2012 are not expected to have a significant effect on the Company’s financial position or results of operations. | |||||
3_Related_Party_Transactions
3. Related Party Transactions | 12 Months Ended |
Dec. 31, 2012 | |
Related Party Transactions [Abstract] | ' |
Related Party Transactions | ' |
Consulting Services: | |
During the year ended December 31, 2012, the Company engaged Chord Advisors, LLC, a financial services outsourcing company, to provide accounting services to the Company for aggregate consideration of $10,000 through March 2013. The Company’s Chief Financial Officer, Richard M. Cohen, is also the Chairman as well as Co-Founder of Chord Advisors, LLC. The Company’s Audit Committee has reviewed and approved this engagement. | |
Notes Payable: | |
On September 20, 2012, Gary A. Gelbfish and Stephen W. Lefkowitz, both members of the Company’s board of directors, and Randy Milby, the Company’s Chief Operating Officer, participated in the Company’s private placement pursuant to the Subscription Agreement referred to in Note 6. Dr. Gelbfish purchased 100 Units, Mr. Lefkowitz purchased 35 Units, indirectly through Wade Capital Corporation Money Purchase Plan (an entity for which he has voting and investment control) and Mr. Milby purchased 50 Units, indirectly through MW Bridges LLC (an entity for which he is Managing Partner, and has voting and investment control). Also, beneficial owners of more than 5% of the Company’s voting securities, including Dr. Lindsay Rosenwald and Elliott Associates, indirectly through Manchester Securities Corp., purchased 50 Units and 400 Units, respectively. | |
On November 13, 2012, Matthew Duffy and Stephen W. Lefkowitz, both members of the Company’s board of directors, participated in the Company’s private placement pursuant to the Subscription Agreement referred to in Note 6. Mr. Duffy purchased 10 Units and Mr. Lefkowitz purchased 15 Units, respectively. | |
In each instance, the purchase was on the same terms as all other purchasers in the offerings. The Audit Committee of the Board of Directors approved the purchase by these insiders. | |
4_Income_Taxes
4. Income Taxes | 12 Months Ended | ||||||||
Dec. 31, 2012 | |||||||||
Income Tax Disclosure [Abstract] | ' | ||||||||
Income Taxes | ' | ||||||||
The Company has no state income benefit for the year ended December 31, 2012 and recorded $493,855 for the year ended December 31, 2011, related to the sale of its state net operating losses. There was no current or deferred income tax provision for the year ended December 31, 2012 and $493,855 for the year ended December 31, 2011. | |||||||||
The Company’s deferred tax assets as of December 31, 2012 and 2011 consist of the following: | |||||||||
2012 | 2011 | ||||||||
Net operating loss carryforwards – Federal | $ | 9,561,000 | $ | 8,612,000 | |||||
Net operating loss carryforwards – state | 1,099,000 | 931,000 | |||||||
Common stock issued to licensors | 2,541,000 | 2,541,000 | |||||||
Amortization of debt discount | 142,000 | - | |||||||
Stock-based compensation | 110,000 | - | |||||||
Other | 80,000 | 80,000 | |||||||
Totals | 13,533,000 | 12,164,000 | |||||||
Less valuation allowance | (13,533,000 | ) | (12,164,000 | ) | |||||
Deferred tax assets | $ | - | $ | - | |||||
At December 31, 2012, the Company had potentially utilizable Federal and state net operating loss tax carryforwards of approximately $28,123,000 and $18,309,000, respectively. The net operating loss tax carryforwards will start to expire in 2026 for Federal purposes and 2013 for state purposes. | |||||||||
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 effective tax rate varied from the statutory rate as follows: | |||||||||
December 31, | |||||||||
2012 | 2011 | ||||||||
Statutory Federal tax rate | (34.0 | )% | (34.0 | )% | |||||
State income tax rate (net of Federal) | (6.0 | )% | (6.0 | )% | |||||
Other permanent differences | 0 | % | 3.9 | % | |||||
Sale of State of New Jersey net operating losses (net of Federal) | 0 | % | (6.9 | )% | |||||
Effect of valuation allowance | 40 | % | 36.1 | % | |||||
Effective tax rate | 0 | % | (6.9 | )% | |||||
A valuation allowance is provided when it is more likely than not that some portion or all of the deferred tax assets will not be realized. The net change in the total valuation allowance for the years ended December 31, 2012 and 2011 and for the period from July 28, 2006 (inception) to December 31, 2012 was $1,369,000, $3,891,000, and $13,533,000, respectively. The tax benefit assumed the Federal statutory tax rate of 34% and a state tax rate of 6% and has been fully offset by the aforementioned valuation allowance. | |||||||||
In July 2006, the Company adopted guidance under ASC Topic 740-10 which clarifies the accounting and disclosure for uncertainty in income taxes. The adoption of this interpretation did not have a material impact on the Company’s financial statements. | |||||||||
Management believes that the Company does not have any tax positions that will result in a material impact on the Company’s financial statements because of the adoption of ASC 740-10. However management’s conclusion may be subject to adjustment at a later date based on ongoing analyses of tax laws, regulations and related Interpretations. The Company will report any tax-related interest and penalties related to uncertain tax positions as a component of income tax expense. The Company’s tax returns from 2009 to 2012 remain open. | |||||||||
5_Commitments_and_Contingencie
5. Commitments and Contingencies | 12 Months Ended | ||||
Dec. 31, 2012 | |||||
Commitments and Contingencies Disclosure [Abstract] | ' | ||||
Commitments and Contingencies | ' | ||||
Operating Lease: | |||||
On March 18, 2010, the Company entered into a lease agreement with UA Bridgewater Holdings, LLC for office space located in Bridgewater, New Jersey, for an initial term of 60 months, with a commencement date of April 1, 2010, an expiration date of March 31, 2015, and lease payments beginning on July 1, 2010. In accordance with the lease agreement, the Company has deposited $13,342 with the landlord, the equivalent of two months’ rent. The Company has been granted the option to extend the lease term for one additional period of three years, commencing the day following the then-current expiration date of the term, March 31, 2015, provided the Company delivers notice to the landlord no later than nine months prior to March 31, 2015. The total 60-month lease obligation is approximately $389,000. The Company’s total remaining lease obligation is $187,167 as of December 31, 2012, as set forth below: | |||||
Schedule of Future Minimum Lease Payments | |||||
Years Ending December 31, | Amount | ||||
2013 | $ | 82,697 | |||
2014 | 83,576 | ||||
2015 | 20,894 | ||||
Total | $ | 187,167 | |||
Employment Agreements: | |||||
On January 14, 2011, the Company entered into an amendment to the employment agreement, effective January 1, 2011, with its Chief Financial Officer, Brian Lenz (the “Lenz Amendment”). The Lenz Amendment amended that certain Employment Agreement, dated as of February 4, 2010, by and between the Company and Mr. Lenz to (i) increase Mr. Lenz’s annual base salary to $250,000 and (ii) eliminate Mr. Lenz’s annual guaranteed bonus. | |||||
On April 27, 2012, in connection with Brian Lenz's resignation as the Company’s Chief Operating Officer and Chief Financial Officer effective April 30, 2012, the Company and Mr. Lenz entered into a Memorandum of Understanding (the "MOU") on May 2, 2012 whereby Mr. Lenz provided certain transition services to the Company through May 31, 2012, and remained reasonably available to the Company, as requested from time to time by the Company from and after May 31, 2012. In exchange for providing such services to the Company, the Company agreed to compensate Mr. Lenz in the amount of $10,417, less applicable taxes and withholdings, in accordance with the regular payroll processing of the Company. Additionally, in consideration of Mr. Lenz's execution of the MOU and performance of the undertakings contained therein, on May 1, 2012, the Compensation Committee of the Board of Directors of the Company approved an extension of Mr. Lenz's right to exercise his 45,000 vested stock options through and including May 31, 2014, in accordance with the terms of the Company's Plan. The options granted to Mr. Lenz on March 20, 2012 have an exercise price of $0.49 per share. Mr. Lenz’s unvested options were forfeited effective April 30, 2012. | |||||
On February 25, 2011, the Company entered into an employment agreement with Mark A. Klausner, M.D. to serve as the Company’s Chief Medical Officer which was amended on February 29, 2012 to provide for a 50% reduction in both Dr. Klausner’s services to the Company and his compensation. Pursuant to the amendment, the Company paid Dr. Klausner an annual base salary equal to $155,000 and, at the sole discretion of the Company’s Board of Directors, the Company could pay Dr. Klausner an additional cash bonus each calendar year during the term in an amount equal to up to 35% of the aggregate base salary. The term of the Employment Agreement commenced on March 1, 2011 and continued for two years. On February 28, 2013, Dr. Klausner’s employment agreement, as amended, was not renewed and Dr. Klausner’s employment terminated. | |||||
On March 1, 2011, in connection with the Klausner Employment Agreement, the Company issued to Dr. Klausner an option to purchase 356,000 shares of the Company’s common stock at an exercise price of $1.61 per share. Such option vested in equal installments on each of the first three anniversaries of the grant date. The stock option had an approximate fair value of approximately $453,100 at the date of grant based on the Black-Scholes option-pricing model. | |||||
Consulting: | |||||
On May 14, 2012, the Company entered into a Consulting Agreement (the “Consulting Agreement”) with MW Bridges LLC, of which Randy Milby is Managing Partner. Pursuant to the Consulting Agreement, Mr. Milby initially served as the Company’s Chief Operating Officer for a monthly retainer of $6,400. In addition, the Company granted Mr. Milby stock options to purchase 50,000 shares of the Company’s common stock, which option vests upon the Company’s receipt of CE Mark approval for CRMD003, Neutrolin®, in accordance with the terms of the Company’s Amended and Restated 2006 Stock Incentive Plan. Further, the Company agreed to reimburse Mr. Milby for all reasonable and necessary expenses incurred while performing services in connection with the Consulting Agreement. The initial term (the “Term”) of the Consulting Agreement was for three months, which expired on or about August 14, 2012. Pursuant to its terms, the Consulting Agreement was renewed upon mutual written agreement of the parties upon the same terms. On October 31, 2012, the Company and MW Bridges LLC entered into an Amendment to the Consulting Agreement (the “Amendment”), which, among other things, (i) extended the then-current Term for an additional three months, and (ii) increased Mr. Milby’s monthly retainer to $12,000, effective October 1, 2012. In addition, either party may terminate the Consulting Agreement, as amended, upon 30 days’ prior written notice. Mr. Milby was named Chief Executive Officer of the Company effective January 1, 2013. The terms and conditions of the Consulting Agreement remained the same. | |||||
On November 9, 2012, the Company entered into a Consulting Agreement (the "Consulting Agreement") with Oliver Buck, pursuant to which Mr. Buck provides services and support to the Company in the field of strategic and corporate development and will specifically include direct general support to the Companys executive management team with regard to strategic planning, corporate development and implementation of mutually agreed to tasks and projects. Mr. Buck received a monthly retainer of $5,400. Any additional work performed by Mr. Buck will be pre-approved by the Company on a case-by-case basis, and Mr. Buck was compensated for such additional work at a rate of $1,800 per day. In addition, the Company granted to Mr. Buck stock options to purchase 200,000 shares of the Companys common stock in accordance with the terms of the Companys Amended and Restated 2006 Stock Incentive Plan. The Options have an exercise price of $0.44, the closing sale price of the Companys common stock, as reported on the NYSE-MKT on November 9, 2012. 50,000 shares of common stock underlying the option vested immediately upon grant with the remainder to vest upon completion of certain operational and strategic milestones, including, but not limited to, receipt of CE Mark approval for CRMD003, Neutrolin. Further, the Company will reimburse Mr. Buck for all reasonable documented and necessary expenses incurred in connection with services provided pursuant to the Consulting Agreement. Such expenses must be pre-approved in writing by the Company. The Consulting Agreement will terminate on November 9, 2013, unless sooner terminated in accordance with its terms. The Consulting Agreement may be extended for additional one-year periods upon mutual written agreement by the parties. The Consulting Agreement may be terminated upon 90 days prior written notice by either party. | |||||
Other: | |||||
The Company has entered into various contracts with third parties in connection with the development of the licensed technology described in Note 9. | |||||
In February 2007, Geistlich Söhne AG für Chemische Industrie, Switzerland, or Geistlich, brought an action against the Sodemann patent covering the Company’s Neutrolin® product candidate which is owned by ND Partners, LLC and licensed to the Company pursuant to the License and Assignment Agreement between the Company and ND Partners LLC. The action that was brought against the Sodemann patent in Germany at the Board of the European Patent Office opposition division was for lack of inventiveness in the use of citric acid and a pH value in the range of 4.5 to 6.5 with having the aim to provide an alternative lock solution through having improved anticoagulant characteristics compared to the lock solutions described in the Lehner patent. The Board of the European Patent Office opposition division rejected the opposition by Geistlich. On August 27, 2008, Geistlich appealed the court's ruling, alleging the same arguments as presented during the opposition proceedings. The Company filed a response to the appeal of Geistlich on March 25, 2009 where the Company requested a dismissal of the appeal and to maintain the patent as granted. As of March 27, 2013, no further petitions have been filed by ND Partners or Geistlich. On October 10, 2012, the Company became aware that the Board of Appeals of the European Patent Office issued on September 4, 2012, a summons for oral proceedings. On November 28, 2012, the Board of Appeals of the European Patent Office held oral proceedings and verbally upheld the Sodemann patent covering Neutrolin®, but remanded the proceeding to the lower court to consider restricting certain of the Sodemann patent claims. The Company believes it will receive the Appeals Board final written decision sometime in the first half of 2013. The Company intends to continue to vigorously defend the patent. However, the Company can provide no assurances regarding the outcome of this matter. | |||||
In the normal course of business, the Company enters into contracts that contain a variety of indemnifications with its employees, licensors, suppliers and service providers. Further, the Company indemnifies its directors and officers who are, or were, serving at the Company’s request in such capacities. The Company’s maximum exposure under these arrangements is unknown as of December 31, 2012. The Company does not anticipate recognizing any significant losses relating to these arrangements. |
6_Convertible_Notes
6. Convertible Notes | 12 Months Ended | ||||||||
Dec. 31, 2012 | |||||||||
Debt Disclosure [Abstract] | ' | ||||||||
Convertible Notes | ' | ||||||||
On September 20, 2012, the Company completed an initial closing of its private placement of 850 Units, each Unit consisting of (i) a one-year $1,000 aggregate principal amount 9% Senior Convertible Note (the "Notes"), convertible into shares (the "Conversion Shares") of common stock, at a conversion price of $0.35 per Note, and (ii) a five-year redeemable Warrant (the "Warrants"), to purchase 2,500 shares of common stock (the "Warrant Shares"), to certain accredited investors (the "Purchasers") pursuant to a Subscription Agreement dated September 20, 2012 (the “Subscription Agreement”). The Units were offered on a "reasonable efforts, all-or-none" basis as to 500 Units for a minimum amount of $500,000 and thereafter on a "reasonable efforts" basis as to the remaining 2,500 Units for a maximum amount of $3,000,000 (the "Maximum Amount"). The Company received gross proceeds of $850,000. The maturity date of the Notes issued in the initial closing is September 20, 2013. | |||||||||
On November 13, 2012, the Company completed the second and final closing of the private placement, and issued an additional 474 Units for a total gross amount of $474,000. The maturity date of the Notes issued in the final closing is November 13, 2013. Together with the sale of 850 Units at the initial closing, the Company issued and sold in the private placement an aggregate total of 1,324 Units for aggregate gross proceeds of $1,324,000. The total net proceeds (net of placement agent and legal fees) of the private placement to the Company were $1,095,600, including $689,000 net proceeds previously received at the initial closing and $406,600 net proceeds received in the final closing. The Company issued to the investors Warrants to purchase an aggregate of 3,310,000 shares of its common stock. The Company paid the placement agent for the private placement a total of $109,900 in fees and issued it warrants to purchase an aggregate of 331,000 shares of its common stock. The placement agent warrants have the same terms as those issued to the investors. | |||||||||
The Notes bear interest at 9% per annum payable quarterly in arrears. The Company shall have the right to prepay, in certain instances, all (but not less than all, subject to certain share ownership limitations) of the then outstanding Notes by paying 120% of the principal and accrued but unpaid interest through and including the date each Note is repaid. | |||||||||
The Purchasers were issued Warrants to purchase the Company's Common Stock, exercisable for a period of five years at an initial exercise price of $0.40, subject to adjustment. The Warrants provide for customary adjustments to the exercise price in the event of stock splits, stock dividends and other similar corporate events and may be exercised on a cashless basis. The Warrants do not confer any voting rights or any other rights as a shareholder. | |||||||||
The Company, upon thirty-day notice to holders of outstanding Warrants, has the right, subject to certain limitations, to redeem all or any portion of the Warrants then outstanding for consideration of $0.001 per Warrant if (i) either (a) there is an effective registration statement for resale of all of the Conversion Shares, or (b) all of the Conversion Shares may be resold pursuant to Rule 144 without any restrictions or limitations, and (ii) for the ten consecutive trading days prior to the date that the Company notifies such holders of such redemption, (a) the daily volume-weight adjusted market price of the Common Stock is equal to or greater than 140% of the then exercise price, and (b) the average daily value of the trading volume is not less than $100,000. | |||||||||
The Company accounts for the beneficial conversion feature (“BCF”) and warrant valuation in accordance with FASB ASC 470-20, Debt with Conversion and Other Options. The Company records a BCF related to the issuance of convertible debt that has conversion features at fixed rates that are “in-the-money” when issued and the fair value of warrants issued in connection with those instruments. The BCF for the convertible instruments is recognized and measured by allocating a portion of the proceeds to warrants, based on their relative fair value, and as a reduction to the carrying amount of the convertible debt equal to the intrinsic value of the conversion feature. The discount recorded in connection with the BCF and warrant valuation is recognized as non-cash interest expense and is amortized over the term of the convertible note. The Company recorded an aggregate of $1,333,307 for the calculated fair value of the warrants and BCF, in conjunction with the convertible notes issued on September 20, 2012 and November 13, 2012. | |||||||||
The Company valued the warrants using the fair value method, at the date the warrants were issued, using the Black-Scholes valuation model and the following assumptions: | |||||||||
September 20, | November 13, | ||||||||
2012 | 2012 | ||||||||
Contractual Term | 5 years | 5 years | |||||||
Volatility | 117.57 | % | 119.15 | % | |||||
Dividend yield | 0 | % | 0 | % | |||||
Risk-free interest rate | 0.7 | % | 0.63 | % | |||||
Senior convertible notes consist of the following at December 31, 2012: | |||||||||
9% Senior convertible notes | $ | 664,000 | |||||||
Debt discount/beneficial conversion feature | (647,939 | ) | |||||||
Balance | $ | 16,061 | |||||||
Accrued interest | $ | 10,763 | |||||||
9% Senior convertible notes, related parties | $ | 660,000 | |||||||
Debt discount/beneficial conversion feature | (406,316 | ) | |||||||
Balance | $ | 253,684 | |||||||
Accrued interest, related parties | $ | 16,175 |
7_Stockholders_Equity_Deficien
7. Stockholders' Equity (Deficiency) | 12 Months Ended | ||||||||||||||||
Dec. 31, 2012 | |||||||||||||||||
STOCKHOLDERS' EQUITY (DEFICIENCY) | ' | ||||||||||||||||
Stockholders' Equity (Deficiency) | ' | ||||||||||||||||
Common Stock: | |||||||||||||||||
During July 2006, the Company issued 510,503 shares of Common Stock to its founders for proceeds of $4,000 or $0.008 per share. | |||||||||||||||||
In accordance with the Shiva Contribution Agreement (see Note 9), during August 2006, the Company issued 800,000 shares of Series B Common Stock, 50,000 shares of Series C Common Stock, 50,000 shares of Series D Common Stock, 50,000 shares of Series E Common Stock and 50,000 shares of Series F Common Stock to Shiva Biomedical, LLC at $0.008 per share. These shares of Series B-F Common Stock were subsequently surrendered by Shiva in exchange for Common Stock in October 2009, as described below, and were eliminated from the Company’s certificate of incorporation pursuant to an amendment effected in connection with such exchange. During 2006, the Company recorded $1,000 in deferred stock issuances for these shares of Series B-F Common Stock which were issued but were held in escrow until achievement of certain future clinical milestones (see Note 9). | |||||||||||||||||
During November 2006, the Company issued 53,743 shares of Common Stock to an employee in connection with an employment agreement for proceeds of $421 or $0.008 per share which vested equally over a three year period. In connection with this stock issuance, the Company recorded compensation expense at $1.72 per share for a total of $92,649. During January and March 2007, the Company issued 27,056 shares of Common Stock to employees in connection with employment agreements for proceeds of $212 or $0.008 per share which vested equally over a three year period. In connection with this stock issuance, the Company recorded compensation expense at $1.72 per share for a total $46,641. During March 2007, the Company issued 193,936 shares of Non-Voting Subordinated Class A Common Stock to technology finders for proceeds of $194 or $0.008 per share which vested equally over a three year period. In connection with this stock issuance, the Company recorded compensation expense at $1.72 per share for a total of $42,666. In accordance with the NDP License Agreement (see Note 9), during January 2008, the Company issued 39,980 shares of Common Stock to ND Partners LLC at $8.23 per share. During 2008, the Company recorded $328,948 in research and development expense in connection with this issuance. In addition, under the NDP License Agreement, the Company issued an additional 15,992 shares of Common Stock which are being held in escrow pending the achievement of certain regulatory and sales-based milestones. During 2008, the Company recorded $125 in deferred stock issuances for this common stock which was issued but is being held in escrow (see Note 9). | |||||||||||||||||
During May 2008, the Company issued 939 shares of Common Stock to a consultant in lieu of payment for consulting services at $8.23 per share. During 2008, the Company recorded $7,721 in research and development expense in connection with this issuance. | |||||||||||||||||
During July 2009, the Company issued 639 shares of Common Stock to a consultant as partial payment for consulting services at $32.05 per share. During 2009, the Company recorded $20,450 in research and development expense in connection with this issuance. | |||||||||||||||||
Pursuant to an amendment to the Shiva Contribution Agreement, dated as of October 6, 2009, and a corresponding common stock exchange and stockholder agreement of the same date (the “Exchange Agreement”), during October 2009, the Company issued 98,739 shares of Common Stock to Shiva Biomedical, LLC at $32.05 per share in exchange for the surrender by Shiva of all rights to the Series B-F Common Stock. During 2009, the Company recorded $3,164,502 in research and development expense in connection with the issuance (See Note 9). | |||||||||||||||||
During October 2009, the Company issued 28,156 shares of Common Stock to ND Partners LLC at $32.05 per share in accordance with the NDP License Agreement as a result of anti-dilution adjustments in connection with the issuance of shares to Shiva Biomedical, LLC under the Exchange Agreement. During 2009, the Company recorded $902,344 in connection with the issuance (See Note 9). | |||||||||||||||||
During October 2009, the Company issued 11,263 shares of Common Stock into escrow for the benefit of ND Partners LLC at $32.05 per share in accordance with the NDP License Agreement as a result of anti-dilution adjustments in connection with the issuance of shares to Shiva Biomedical, LLC under the Exchange Agreement (See Note 9). | |||||||||||||||||
During February 2010, the Company issued 4,059 shares of Common Stock to a consultant as payment for consulting services at $32.05 per share. During 2010, the Company recorded $130,091 in general and administrative expense in connection with this issuance. | |||||||||||||||||
During February 2010, the Company issued 24,750 shares of Common Stock to technology finders as a result of the conversion of Non-Voting Subordinated Class A Common Stock to Common Stock. | |||||||||||||||||
During March 2010, the Company issued a total of 5,914,431 shares of Common Stock to the holders of its convertible notes as a result of the conversion of such notes into Common Stock in conjunction with the IPO. | |||||||||||||||||
During March 2010, the Company issued a total of 828,024 shares of Common Stock to Shiva Biomedical, LLC and ND Partners LLC at $3.125 per share, as a result of anti-dilution adjustments pursuant to their respective agreements, of which 145,543 shares are being held in escrow for ND Partners LLC pending the achievement of certain regulatory and sales-based milestones. The anti-dilution provisions under these agreements were terminated upon the completion of the Company’s IPO in March 2010 (See Note 9). | |||||||||||||||||
During March 2010, the Company issued 3,850,000 shares of Common Stock in connection with the Company’s IPO at a per share price of $3.125. | |||||||||||||||||
Common Stock Options: | |||||||||||||||||
In 2006, the Company established a stock incentive plan (the “Plan”) under which restricted stock, stock options and other awards based on the Company’s common stock could be granted to the Company’s employees, directors, consultants, advisors and other independent contractors. On January 28, 2010, the Company amended and restated the Plan to, among other things, increase the shares of common stock issuable under the Plan from 925,000 to 2,300,000. Options issuable under the Plan have a maximum term of ten years, vest over a period to be determined by the Company’s Board of Directors (the “Board”), and have an exercise price at or above the fair market value on the date of grant. At December 31, 2012, there were 164,370 stock options available for issuance under the Plan. | |||||||||||||||||
During the year ended December 31, 2012, the Company granted the following stock options to purchase shares of common stock under the Plan: | |||||||||||||||||
● An aggregate of 765,000 ten-year stock options was granted to various directors and officers of the Company with an exercise price of $0.68 per share based on the closing price of the Company’s common stock on the date of grant. These options will vest as to 50% on the date of the issuance of the CE Mark approval in Europe for the Company’s Neutrolin® product candidate, if the CE Mark approval is obtained on or before March 31, 2013, and 50% will vest on December 31, 2013. The Company believes that it is not probable that the objective will be achieved by the end of March 2013. Subsequently, in March 2013, the vesting of the 50% performance options was amended to vest on the date of issuance of the CE Mark if issued on or before June 30, 2013 as opposed to March 31, 2013. At December 31, 2012, the Company did not record any expense related to the 50% performance options and is expensing the vesting of the remaining 50% options through December 31, 2013. The Company expects that by June 30, 2013, it is probable that such objective will be achieved and will record the expense from January 1, 2013 through June 30, 2013. There will be accounting implications during the first quarter of 2013 as a result of this modification. | |||||||||||||||||
● 25,000 ten-year stock options were granted to a consultant of the Company with an exercise price of $0.68 per share based on the closing price of the Company’s common stock on the date of grant. These options will vest as to 50% on the date of the issuance of the CE Mark approval in Europe for the Company’s Neutrolin® product candidate, if the CE Mark approval is obtained on or before March 31, 2013, and 50% will vest on December 31, 2013. The Company believes that it is not probable that the objective will be achieved by the end of March 2013. Subsequently, in March 2013, the vesting schedule of the 50% performance options was amended to vest on the date of issuance of the CE Mark if issued on or before June 30, 2013 as opposed to March 31, 2013. Since such objective was not achieved as of December 31, 2012, no expense related to the 50% performance options was recorded at December 31, 2012. The Company is expensing the vesting of the remaining 50% options through December 31, 2013. | |||||||||||||||||
● 200,000 five-year stock options were granted to a consultant of the Company with an exercise price of $0.44 per share based on the closing price of the Company’s common stock on the date of grant. 50,000 of these options vested immediately at the date of grant and the remainder to vest upon completion of certain operational and strategic milestones, including, but not limited to, receipt of CE Mark approval for CRMD003, Neutrolin®. For the year ended December 31, 2012, the Company recorded the expense related to the 50,000 stock options that vested immediately. For the remaining 150,000 stock options, no expense was recorded for the year ended December 31, 2012 since such milestones were not achieved at December 31, 2012. | |||||||||||||||||
● 10,000 five-year stock options were awarded to a consultant of the Company with an exercise price $0.24 per share based on the closing price of the Company’s common stock on the date of grant. Vesting is contingent upon the receipt of the Company’s Neutrolin® CE Mark. Since such objective was not achieved as of December 31, 2012, no expense related to this grant was recorded by the Company for the year ended December 31, 2012. | |||||||||||||||||
● 50,000 ten-year stock options were awarded to a consultant of the Company with an exercise price of $0.29 per share based on the closing price of the Company’s common stock on the date of grant. Vesting is contingent upon the receipt of the Company’s Neutrolin® CE Mark. This consultant met the classification of an employee but the Company expects that it is not probable that such objective will be achieved by March 2013. Subsequently, in March 2013, the Company amended the timeline of the CE Mark that it will be issued on or before June 30, 2013 as opposed to March 31, 2013. The Company expects that it is probable that such objective will be achieved by June 30, 2013. Therefore, the Company did not expense the vesting of these options at December 31, 2012 and will record the expense from January 1, 2013 through June 30, 2013. | |||||||||||||||||
● 180,000 stock options were granted to the Company’s former Chief Operating Officer/Chief Financial Officer (“COO/CFO”) with an exercise price of $0.49 per share. As a result of the Company’s COO/CFO’s resignation in April 2012, all of the options mentioned above except for the 45,000 vested options were forfeited. The vested 45,000 stock options were amended to extend the exercise period up to and through May 31, 2014. The Company re-measured and recorded as an expense the value of the 45,000 stock options and reversed the recorded expense of the forfeited stock options. | |||||||||||||||||
During the year ended December 31, 2011, the Company granted options to purchase 886,000 shares of common stock under the Plan to various employees, officers, directors and a consultant ranging from $1.10 to $2.10 per share exercise price. Each option granted to employees during the year ended December 31, 2011 has a ten-year term and vests equally over a three-year period. | |||||||||||||||||
The Company recorded $274,358, $692,403 and $2,599,238 of stock-based compensation expense during the years ended December 31, 2012 and 2011 and the period from July 28, 2006 (inception) to December 31, 2012, respectively, in accordance with ASC 718 and ASC 505 for stock options issued to employees and non-employees, respectively. | |||||||||||||||||
A summary of the Company’s stock options activity under the Plan and related information is as follows: | |||||||||||||||||
Year Ended | Year Ended | ||||||||||||||||
31-Dec-12 | 31-Dec-11 | ||||||||||||||||
Shares | Weighted | Shares | Weighted | ||||||||||||||
Average | Average | ||||||||||||||||
Exercise | Exercise | ||||||||||||||||
Price | Price | ||||||||||||||||
Outstanding at beginning of year | 1,236,342 | $ | 2.47 | 1,662,827 | $ | 3.15 | |||||||||||
Granted | 1,380,000 | $ | 0.56 | 886,000 | $ | 1.67 | |||||||||||
Cancelled | (217,662 | ) | $ | 3.13 | - | $ | - | ||||||||||
Forfeited | (263,050 | ) | $ | 1.72 | (1,312,485 | ) | $ | 2.79 | |||||||||
Outstanding at end of year | 2,135,630 | $ | 1.26 | 1,236,342 | $ | 2.47 | |||||||||||
Outstanding at end of year expected to vest | 961,034 | $ | 1.26 | 1,236,342 | $ | 2.47 | |||||||||||
Options exercisable | 758,297 | $ | 2.16 | 476,014 | $ | 3.02 | |||||||||||
Weighted-average fair value of options granted during the year | $ | 0.46 | $ | 1.33 | |||||||||||||
The weighted average remaining contractual life of stock options outstanding at December 31, 2012 is 7.4 years. 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 as of December 31, 2012 for those options that have an exercise price below the quoted closing price. As of December 31, 2012, the aggregate intrinsic value of all stock options outstanding is $201,950. | |||||||||||||||||
The Company has experienced forfeitures of stock options issued to its former officers, board members and employees. As a result of such forfeitures during 2011 and 2012, the Company has established a forfeiture rate of 55% for stock option expense for the year ended December 31, 2012. The Company will continue to evaluate the estimated forfeiture rate derived from previous forfeitures of employees, officers and directors and may adjust such forfeiture rate accordingly. As of December 31, 2012, the total compensation expense related to non-vested options not yet recognized totaled $702,880. The weighted-average vesting period over which the total compensation expense related to non-vested options not yet recognized at December 31, 2012 was approximately 0.6 years. | |||||||||||||||||
Warrants | |||||||||||||||||
The following table is the summary of warrants outstanding at December 31, 2012: | |||||||||||||||||
Number of | Exercise | Expiration | |||||||||||||||
Warrants | Price | Date | |||||||||||||||
Issued to various consultants | 17,869 | $ | 10.66 | 1/30/13 | |||||||||||||
Issued to co-placement agents in connection with previous | 18,250 | 7.84 | |||||||||||||||
convertible note financings | 10/29/14 | ||||||||||||||||
Issued in connection with 2009 private placement | 503,034 | 3.4375 | 10/29/14 | ||||||||||||||
Issued in connection with IPO | 4,263,569 | 3.4375 | 3/24/15 | ||||||||||||||
Issued to IPO underwriters that, if exercised, would result in the | 4,812 | 3.9 | |||||||||||||||
issuance of an additional 4,812 shares of common stock and | |||||||||||||||||
warrants to purchase an additional 2,406 shares of common | |||||||||||||||||
stock | 3/24/15 | ||||||||||||||||
Issued in connection with September 20, 2012 private placement | 2,125,000 | 0.4 | |||||||||||||||
of convertible notes | 9/20/17 | ||||||||||||||||
Issued to placement agent in connection with September 20, | 212,500 | 0.4 | |||||||||||||||
2012 private placement of convertible notes | 9/20/17 | ||||||||||||||||
Issued in connection with November 13, 2012 private placement | 1,185,000 | 0.4 | |||||||||||||||
of convertible notes | 11/13/17 | ||||||||||||||||
Issued to placement agent in connection with November 13, | 118,500 | 0.4 | |||||||||||||||
2012 private placement of convertible notes | 11/13/17 | ||||||||||||||||
Total warrants outstanding at December 31, 2012 | 8,448,534 |
8_Fair_Value_Measurements
8. Fair Value Measurements | 12 Months Ended |
Dec. 31, 2012 | |
Fair Value Measurements [Abstract] | ' |
Fair Value Measurements | ' |
The fair value of the Company’s cash and cash equivalents, convertible notes and accounts payable at December 31, 2012 and 2011 are estimated to approximate their carrying values due to the relative liquidity and short term nature of these instruments. |
9_License_and_Other_Agreements
9. License and Other Agreements | 12 Months Ended |
Dec. 31, 2012 | |
License and Other Agreements [Abstract] | ' |
License and Other Agreements | ' |
On July 28, 2006, the Company entered into a contribution agreement (as amended on October 6, 2009 and on February 22, 2010) (the “Shiva Contribution Agreement”) with Shiva Biomedical, LLC, a New Jersey limited liability company (“Shiva”), and certain other parties. Pursuant to the Shiva Contribution Agreement, Shiva contributed to the Company its kidney products business and granted the Company an exclusive, worldwide license agreement for a patent estate covering proprietary formulations of the first “iron chelator” for kidney diseases, specifically deferiprone (the “Compound”), and a biomarker diagnostic test for measuring levels of labile iron (the “Test”). Specifically, the Company licensed treatment, formulation and dosing regimens and methods of using the Compound and the Test, for the treatment and diagnosis of diseases and disorders, and the corresponding United States and foreign patents and applications in all fields of use (collectively, the “Shiva Technology”). As consideration in part for the rights to the Shiva Technology, the Company paid Shiva an initial licensing fee of $500,000 and granted Shiva up to a 20% equity interest in the Company consisting of shares of the Company’s Series B, C, D, E and F Common Stock which were placed in escrow to be released upon the achievement of certain clinical milestones. Pursuant to the October 2009 amendment and corresponding Exchange Agreement, Shiva surrendered all rights to such shares in exchange for 7.0% of the outstanding shares of Common Stock as of the date of exchange, or 98,739 shares (see Note 7). The Company was also obligated to issue additional shares of Common Stock to Shiva sufficient to maintain its ownership percentage at 7.0% of the outstanding Common Stock on a fully diluted basis, and the Company issued an additional 412,338 shares to Shiva at a price of $3.125 per share as a result of this obligation in connection with the Company’s IPO; however, such anti-dilution obligation terminated upon the completion of the IPO. In addition, the Company was required to make substantial payments to Shiva upon the achievement of certain clinical and regulatory based milestones. The maximum aggregate amount of such milestone payments, assuming achievement of all milestones, is $10,000,000. Events that trigger milestone payments included, but were not limited to, the reaching of various stages of clinical trials and regulatory approval processes. In the event that the Shiva Technology was commercialized, the Company was obligated to pay to Shiva annual royalties based upon net sales of the product. In the event that the Company sublicensed the Shiva Technology to a third party, the Company was obligated to pay to Shiva a portion of the royalties, fees or other lump-sum payments it receives from the sublicense, subject to certain deductions. Through December 31, 2011, no milestone payments or royalty payments had been earned by or paid to Shiva. The Company had the right to terminate the Shiva Contribution Agreement for any reason upon 30 days prior written notice. On December 1, 2011, the Company issued Shiva a notice of termination letter of the license agreement and, as such, had no further financial obligation to Shiva. The Company reassigned to Shiva all of the Company’s intellectual property rights with respect to the Shiva Technology. | |
On February 22, 2010, the Company and Shiva entered into an amendment to the Shiva Contribution Agreement, pursuant to which the Company’s deadline for meeting a certain development progress requirement was extended from April 30, 2010 to June 30, 2010 and the Company paid $25,000 to Shiva following completion of the Company’s IPO, as partial reimbursement for Shiva’s expenses in connection with such amendment and prior amendments to the Shiva Contribution Agreement. | |
On August 29, 2011, the Company and Shiva entered into an amendment to the Shiva Contribution Agreement, pursuant to certain changes with respect to the development and milestone payments of the licensed products. | |
During the year ended December 31, 2011 and the period from July 28, 2006 (Inception) to December 31, 2012, the Company expensed $100,000 and $4,920,310, respectively, in connection with the Shiva Contribution Agreement. | |
In connection with the Shiva Contribution Agreement, on July 28, 2006, the Company entered into a Consulting Agreement with Dr. Sudhir Shah, which was amended and restated on April 1, 2010 as a Scientific Advisory Board Agreement (the “Shah Consulting Agreement”) and was further amended and restated on August 29, 2011. Pursuant to the Shah Consulting Agreement, as amended, for a period of one year commencing on April 1, 2010, Dr. Shah provided the Company with consulting services involving areas mutually agreed to by Dr. Shah and the Company and beginning on August 29, 2011 provided consulting services for up to 17.5 hours per month and served on one of the Company’s Scientific Advisory Boards. During the year ended December 31, 2011 and the period from July 28, 2006 (Inception) to December 31, 2012, the Company expensed $29,000 and $196,000, respectively, in connection with the Shah Consulting Agreement. | |
On January 30, 2008, the Company entered into a License and Assignment Agreement (the “NDP License Agreement”) with ND Partners LLC, a Delaware limited liability company (“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 our 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. NDP also granted the Company exclusive licenses, with the right to grant sublicenses, to use and display certain trademarks in connection with the NDP Technology. As consideration in part for the rights to the NDP Technology, the Company paid NDP an initial licensing fee of $325,000 and granted NDP a 5% equity interest in the Company, consisting of 39,980 shares of the Company’s Common Stock. In connection with this stock issuance, the Company recorded $328,948 of research and development expense in 2008. 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 Company was also obligated to issue additional shares of common stock to NDP sufficient to maintain its ownership percentage at 5.0% of the outstanding common stock (7.0%, including the escrow shares) on a fully diluted basis, until such time that the Company has raised $25 million through the sale of its equity securities or until an initial public offering, reverse merger or a sale of the Company. As a result of this obligation, in October 2009, the Company issued an additional 28,156 shares to NDP and an additional 11,263 shares into the escrow, at a price of $32.05 per share, in connection with the issuance of shares to Shiva under the Exchange Agreement as described above, and in March 2010 the Company issued an additional 297,398 shares to NDP and an additional 118,288 shares into the escrow, at a price of $3.125 per share, in connection with the Company’s IPO; however, such anti-dilution obligation terminated upon the completion of the IPO. The maximum aggregate number of shares issuable upon achievement of milestones and the number of shares held in escrow as of December 31, 2011 is 145,543 shares of common stock. The maximum aggregate amount of cash payments upon achievement of milestones is $3,000,000. Events that trigger milestone payments include but are not limited to the reaching of various stages of regulatory approval processes and certain worldwide net sales amounts. Through December 31, 2011, no milestone payments have been earned by or paid to NDP. | |
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. | |
During the period from July 28, 2006 (Inception) to December 31, 2012, the Company expensed $2,515,782 in connection with the NDP License Agreement. | |
On January 30, 2008, the Company also entered into an Exclusive License and Consulting Agreement with Dr. Polaschegg (the “Polaschegg License Agreement”). The Polaschegg License Agreement replaced the original license agreement between NDP and Dr. Polaschegg that the Company was assigned and the Company assumed under the NDP License Agreement. Pursuant to the Polaschegg License Agreement, Dr. Polaschegg granted the Company an exclusive, worldwide license for a certain antimicrobial solution and certain taurolidine treatments and the corresponding United States patent applications (the “Polaschegg Technology”), and agreed to provide the Company with certain consulting services. As consideration for the rights to the Polaschegg Technology, the Company paid Dr. Polaschegg an initial payment of $5,000 and agreed to pay Dr. Polaschegg certain royalty payments ranging from 1% to 3% of the net sales of the Polaschegg Technology. The Polaschegg License Agreement also sets forth certain minimum royalty payments (on an annual basis) to be made to Dr. Polaschegg in connection with the Polaschegg Technology, which payments range from $10,000 to $90,000. As compensation for Dr. Polaschegg’s consulting services to be provided under the Polaschegg License Agreement, Dr. Polaschegg is being paid €200 per hour for services consisting of scientific work and €250 per hour for services consisting of legal work. | |
The Company may terminate the Polaschegg License Agreement with respect to any piece of the Polaschegg Technology upon 60 days notice. If the Polaschegg License Agreement is terminated with respect to any piece of the Polaschegg Technology by either party, all rights with respect to such portion of the Polaschegg Technology will revert to Dr. Polaschegg. | |
During the years ended December 31, 2012 and 2011 and the period from July 28, 2006 (Inception) to December 31, 2012, the Company expensed approximately $45,000, $53,000 and $421,000, respectively, in connection with the Polaschegg License Agreement. | |
Navinta LLC, a U.S.-based Active Pharmaceutical Ingredient (“API”) developer, provides API manufacturing (manufactured in India at an FDA-compliant facility) and a Drug Master File for CRMD003, pursuant to a supply agreement dated December 7, 2009 (the “Navinta Agreement”). The Navinta Agreement provides that Navinta 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 purchased a minimum of $350,000 of product from Navinta by December 30, 2010, which the Company achieved, and following the Company’s first commercial sale of a product incorporating taurolidine, purchase a minimum of $2,250,000 of product on an annual basis for five years. The Company is also required to make certain cash payments to Navinta upon the achievement of certain sales-based milestones. The maximum aggregate amount of such payments, assuming achievement of all milestones, is $1,975,000. The Navinta Agreement has a term of five years, but may be terminated by either party upon 30 days written notice. | |
10_Retirement_Plan
10. Retirement Plan | 12 Months Ended |
Dec. 31, 2012 | |
Compensation and Retirement Disclosure [Abstract] | ' |
Retirement Plan | ' |
On May 1, 2010, the Company adopted a 401(k) savings plan (the “401(k) Plan”) for the benefit of its employees. Under the safe harbor provisions of the 401(k) Plan, the Company is required to make contributions equal to 3% of eligible compensation for each eligible employee whether or not the employee contributes to the 401(k) Plan. For the years ended December 31, 2012 and 2011 and from July 28, 2006 (inception) through December 31, 2012, the Company has recorded $11,370, $26,651 and $44,390, respectively, of required contributions in accordance to the Safe Harbor provision of the 401(k) Plan. |
11_Subsequent_Events
11. Subsequent Events | 12 Months Ended | |
Dec. 31, 2012 | ||
Subsequent Events [Abstract] | ' | |
Subsequent Events | ' | |
On January 9, 2013, the Company filed a registration statement with the SEC to register the resale of the shares of common stock issuable upon the conversion of the Notes and the exercise of the Warrants, which filing was within 60 days after the final closing, as required. Also, the Company agreed to use its commercially reasonable efforts to have the registration statement declared effective within 120 days after the date of the final closing, which is March 13, 2013. Because the registration statement was not declared effective by March 13, 2013, the Company is obligated to pay as partial liquidated damages an aggregate amount equal to 1.0% per month of $875,000 (the aggregate purchase price of the notes for which the underlying shares are being registered), or $8,750 per month (prorated if less than a month) until the registration statement is declared effective, but these payments may not exceed 5% of the aggregate principal amount of the notes outstanding, or $43,750 in the aggregate. | ||
On February 19, 2013, the Company sold to an existing institutional investor, 761,429 shares of its newly created Series A Non-Voting Convertible preferred stock and a warrant to purchase up to 400,000 shares of the Company’s common stock, for gross proceeds of $533,000. The Series A shares and the warrant were sold together at a price of $0.70 per share for each share of Series A stock. Each share of Series A Stock is convertible into one share of the Company’s common stock at any time at the holder’s option. However, the holder will be prohibited from converting Series A Stock into shares of common stock if, as a result of such conversion, the holder, together with its affiliates, would own more than 3.99% of the total number of shares of the Company’s common stock then issued and outstanding. In the event of the Company’s liquidation, dissolution, or winding up, holders of the Series A Stock will receive a payment equal to $0.001 per share of Series A Stock before any proceeds are distributed to the holders of common stock. Shares of the Series A Stock will not be entitled to receive any dividends, unless and until specifically declared by the Company’s board of directors, and will rank: | ||
● | senior to all common stock; | |
● | senior to any class or series of capital stock hereafter created specifically by its terms junior to the Series A Stock; | |
● | on parity with our Series A Preferred Stock and any class or series of capital stock hereafter created specifically ranking by its terms on parity with the Series A Stock; and | |
● | junior to any class or series of capital stock hereafter created specifically ranking by its terms senior to the Series A Stock; | |
● | in each case, as to distributions of assets upon our liquidation, dissolution or winding up whether voluntarily or involuntarily. | |
The warrant is exercisable immediately upon issuance and has an exercise price of $1.50 per share and a term of five years. However, the holder will be prohibited from exercising the warrant if, as a result of such exercise, the holder, together with its affiliates, would own more than 3.99% of the total number of shares of the Company’s common stock then issued and outstanding. In a separate transaction, on February 19, 2013, the Company repurchased from the same institutional investor outstanding warrants to purchase an aggregate of 220,000 shares of the Company’s common stock at a purchase price of $0.15 per share underlying the warrant. The warrants were issued in the Company’s initial public offering and have an exercise price of $3.4375. The repurchased warrants were cancelled. | ||
On February 22, 2013, an aggregate of 474,105 shares of the Series A non-voting convertible preferred stock was converted into 474,105 shares of common stock. | ||
On March 5, 2013, the Company was informed by TÜV SÜD, the European notified body managing the CE Mark application for the Company’s product candidate Neutrolin®, that the Medicinal Evaluation Board of the Netherlands, or MEB, gave the Company a positive response on the clinical aspect of our application. The MEB is responsible for authorizing and monitoring safe and effective medicinal products on the Dutch market and shares responsibility for authorizing medicinal products throughout the European Union. The Company is now working on the final packaging for Neutrolin® with internationally recognized consultants and a leading packaging systems company to meet TÜV-SÜD requirements. As a result, the Company anticipates final approval for the CE Mark certification for Neutrolin® during the second quarter in 2013. Additionally, to lead the commercialization of Neutrolin® in the European Union, the Company formed a European subsidiary, CorMedix Europe GmbH. | ||
On March 6, 2013, the Company’s board of directors approved an amendment to the vesting schedule of the options granted on December 5, 2012. Given the anticipated final approval for the CE Mark certification for Neutrolin® during the first half of 2013, such options will now vest as to 50% on the date of issuance of the CE Mark certification for Neutrolin® in Europe, if the CE Mark approval is obtained on or before June 30, 2013 (as opposed to March 31, 2013 as previously provided by our Board), and 50% on December 31, 2013. | ||
On March 20, 2013, the Company’s board of directors approved the 2013 Stock Incentive Plan (the “2013 Plan”). The 2013 Plan provides for the issuance of equity grants in the form of options, restricted stock, stock awards and other forms of equity compensation. Awards may be made to directors, officers, employees and consultants under the 2013 Plan. An aggregate of 5,000,000 shares of the Company’s common stock is reserved for issuance under the 2013 Plan. Also on March 20, 2013, the Company granted non-statutory stock options covering an aggregate of 1,400,000 shares of the Company’s common stock to all consultants and directors. The consultant options vest upon specified performance milestones, with vesting over one to three years. The director options vest over two years, but do not have performance milestones. The 2013 Plan and the options granted under it are subject to the approval of the Company’s stockholders. |
12_Restatement_of_Consolidated
12. Restatement of Consolidated Financial Statements | 12 Months Ended | ||||||||||||||||||||||||
Dec. 31, 2012 | |||||||||||||||||||||||||
Equity [Abstract] | ' | ||||||||||||||||||||||||
12. Restatement of Consolidated Financial Statements | ' | ||||||||||||||||||||||||
The Company has identified an error resulting in decreases in liabilities and accumulated deficit, and decreases in research and development expense and net loss for the years ended December 31, 2012 and 2011 and for the cumulative period from July 28, 2006 (Inception) through December 31, 2012. The following table illustrates the effect on each line item as of and for the years ended December 31, 2012 and 2011 and the cumulative period from July 28, 2006 (Inception) to December 31, 2012: | |||||||||||||||||||||||||
Cumulative Period from July 28, 2006 (Inception) Through December 31, 2012 | |||||||||||||||||||||||||
31-Dec-12 | 31-Dec-11 | ||||||||||||||||||||||||
As Previously | As Previously | As Previously | |||||||||||||||||||||||
Reported | As Restated | Reported | As Restated | Reported | As Restated | ||||||||||||||||||||
($) | ($) | ($) | ($) | ($) | ($) | ||||||||||||||||||||
Balance Sheets: | |||||||||||||||||||||||||
Accounts payable | 1,023,553 | 928,553 | 1,008,493 | 913,493 | - | - | |||||||||||||||||||
Accrued expense | 306,983 | 261,983 | - | - | - | - | |||||||||||||||||||
Total current liabilities | 1,616,456 | 1,476,456 | 1,305,005 | 1,210,005 | - | - | |||||||||||||||||||
Total Liabilities | 1,628,641 | 1,488,641 | 1,319,477 | 1,224,477 | - | - | |||||||||||||||||||
Deficit accumulated during | (46,373,234 | ) | (46,233,234 | ) | (42,947,552 | ) | (42,852,552 | ) | - | - | |||||||||||||||
the development stage | |||||||||||||||||||||||||
Total Stockholders’ Equity | (475,376 | ) | (335,376 | ) | 1,236,528 | 1,331,528 | - | - | |||||||||||||||||
(Deficiency) | |||||||||||||||||||||||||
Statement of Operations: | |||||||||||||||||||||||||
Research and development | 1,187,631 | 1,142,631 | 4,098,225 | 4,058,225 | 23,343,305 | 23,203,305 | |||||||||||||||||||
Total Operating Expenses | 3,044,711 | 2,999,711 | 7,246,984 | 7,206,984 | 36,119,339 | 35,979,339 | |||||||||||||||||||
Loss from Operations | (3,044,711 | ) | (2,999,711 | ) | (7,246,984 | ) | (7,206,984 | ) | (36,119,339 | ) | (35,979,339 | ) | |||||||||||||
Loss Before Income Taxes | (3,425,682 | ) | (3,380,682 | ) | (7,205,128 | ) | (7,165,128 | ) | (47,148,009 | ) | (47,008,009 | ) | |||||||||||||
Net Loss | (3,425,682 | ) | (3,380,682 | ) | (6,711,273 | ) | (6,671,273 | ) | (46,373,234 | ) | (46,233,234 | ) | |||||||||||||
Net Loss per Common Share | |||||||||||||||||||||||||
Basic and Diluted | (0.30 | ) | (0.30 | ) | (0.59 | ) | (0.58 | ) | - | - | |||||||||||||||
Statement of Cash Flows: | |||||||||||||||||||||||||
Net loss | (3,425,682 | ) | (3,380,682 | ) | (6,711,273 | ) | (6,671,273 | ) | (46,373,234 | ) | (46,233,234 | ) | |||||||||||||
Accounts payable | - | - | (130,783 | ) | (170,783 | ) | 992,750 | 897,750 | |||||||||||||||||
Accrued expenses and accrued | 26,646 | (18,354 | ) | - | - | 323,158 | 278,158 | ||||||||||||||||||
interest | |||||||||||||||||||||||||
Deficit Accumulated During the Development Stage | Total Stockholders’ Equity (Deficiency) | ||||||||||||||||||||||||
As Previously | As Previously | ||||||||||||||||||||||||
Reported | As Restated | Reported | As Restated | ||||||||||||||||||||||
($) | ($) | ($) | ($) | ||||||||||||||||||||||
Statement of Stockholders’ Equity | |||||||||||||||||||||||||
(Deficiency): | |||||||||||||||||||||||||
Net loss | (8,121,455 | ) | (8,096,455 | ) | - | - | |||||||||||||||||||
Balance December 31, 2009 | (25,331,043 | ) | (25,306,043 | ) | (14,708,899 | ) | (14,683,899 | ) | |||||||||||||||||
Net loss | (10,905,236 | ) | (10,875,236 | ) | - | - | |||||||||||||||||||
Balance December 31, 2010 | (36,236,279 | ) | (36,181,279 | ) | 7,255,398 | 7,310,398 | |||||||||||||||||||
Net loss | (6,711,273 | ) | (6,671,273 | ) | - | - | |||||||||||||||||||
Balance December 31, 2011 | (42,947,552 | ) | (42,852,552 | ) | 1,236,528 | 1,331,528 | |||||||||||||||||||
Net loss | (3,425,682 | ) | (3,380,682 | ) | - | - | |||||||||||||||||||
Balance December 31, 2012 | (46,373,234 | ) | (46,233,234 | ) | (475,376 | ) | (335,376 | ) | |||||||||||||||||
2_Summary_of_Significant_Accou1
2. Summary of Significant Accounting Policies (Policies) | 12 Months Ended | ||||
Dec. 31, 2012 | |||||
Accounting Policies [Abstract] | ' | ||||
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 deposit and other interest bearing accounts, the balances of which, at times, may exceed Federally insured limits. | |||||
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. | |||||
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. | |||||
Property and Equipment | ' | ||||
Property and equipment consist primarily of furnishings, fixtures, leasehold improvements, office equipment and computer equipment which are recorded at cost. Repairs and maintenance costs are expensed in the period incurred. Depreciation of property and equipment 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, net as of December 31, 2012 and 2011 were $4,668 and $11,689, respectively, net of accumulated depreciation of $57,042, and $50,020, respectively. | |||||
Description | Estimated Useful Life | ||||
Office equipment and furniture | 5 years | ||||
Leasehold improvements | 5 years | ||||
Computer equipment | 5 years | ||||
Computer software | 3 years | ||||
Stock-Based Compensation | ' | ||||
The Company accounts for stock options granted to employees according to the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) No. 718 (“ASC 718”), “Compensation — Stock Compensation”. Under ASC 718, share-based compensation cost is measured at the grant date, based on the estimated fair value of the award, and is recognized as expense over the employee’s requisite service period on a straight-line basis. | |||||
The Company accounts for stock options granted to non-employees on a fair value basis using the Black-Scholes option pricing method in accordance with ASC 718. The initial noncash charge to operations for non-employee options with service vesting are revalued at the end of each reporting period based upon the change in the fair value of the options and amortized to expense over the related vesting period. For stock options granted to non-employees with vesting contingent upon various performance metrics, the Company used the guidelines in accordance with FASB ASC No. 505-50 (“ASC 505”), “Equity-Based Payments to Non-Employees”, of which if the performance condition is outside of the control of the non-employee, the cost to be recognized is the lowest aggregate fair value prior to the achievement of the performance condition, even if the Company believes it is probable that the performance condition will be achieved. As of December 31, 2012, the performance conditions of such stock options were not achieved; therefore, no non-employee stock options vested and no expense was recorded during the year ended December 31, 2012. For the purpose of valuing performance based options granted to a non-employee during the year ended December 31, 2011, the Company used the standard Monte Carlo stock price simulation method. To estimate the number of stock options expected to vest, the Company used the Monte Carlo stock price simulation method. The Monte Carlo analysis uses several random simulations along with performance vesting metrics, an initial stock price of $1.72, expected volatility of 100% for the one-year period of the vesting contingency and a one-year risk-free rate of 0.25%. The Company then used the results of the Monte Carlo analysis together with the Black-Scholes option pricing model to estimate the fair value of the options issued. 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 our awards. The Company estimated the expected term of the options granted based on anticipated exercises in future periods assuming the success of the Company’s business model as currently forecasted. | |||||
For the purpose of valuing options and warrants granted during the year ended December 31, 2012, the Company used the Black-Scholes option pricing model. The Company estimated the expected term of the stock options granted based on anticipated exercises in future periods assuming the success of its business model as currently forecasted for employees, officers and directors. The expected dividend yield of 0.0% reflects the Company’s current and expected future policy for dividends on the Company’s common stock. To determine the risk-free interest rate, the Company utilized the U.S. Treasury yield curve in effect at the time of grant with a term consistent with the expected term of the Company’s awards. The expected stock price volatility for the stock options was calculated by examining historical volatilities for publicly traded industry peers, since the Company does not have a significant trading history for its common stock. The Company will continue to analyze the expected stock price volatility and expected term assumptions as more historical data for its common stock becomes available. The Company has experienced forfeitures of stock options issued to its former employees, officers, directors and board members. Since the stock options currently outstanding are primarily held by the Company’s senior management and directors, the Company will continue to evaluate the effects of such future potential forfeitures, as they may arise, to ascertain an estimated forfeiture rate. | |||||
2012 | 2011 | ||||
Risk-free interest rate | 0.27% – 1.6% | 0.9% – 2.1% | |||
Expected volatility | 98% – 127% | 109% – 115% | |||
Expected life of options in years | 5 | 5 | |||
Expected dividend yield | 0.00% | 0.00% | |||
Research and Development | ' | ||||
Research and development costs are charged to expense as incurred. Research and development includes fees associated with operational consultants, contract clinical research organizations, contract manufacturing organizations, clinical site fees, contract laboratory research organizations, contract central testing laboratories, licensing activities, and allocated executive, human resources and facilities expenses. The Company accrues for costs incurred as the services are being provided by monitoring the status of the trial and the invoices received from its external service providers. As actual costs become known, the Company adjusts its accruals in the period when actual costs become known. Costs related to the acquisition of technology rights and patents for which development work is still in process are charged to operations as incurred and considered a component of research and development expense. | |||||
Income Taxes | ' | ||||
Under ASC 740, “Income Taxes” (“ASC 740”), 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. Under ASC 740, 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. | |||||
Loss Per Common Share | ' | ||||
Basic earnings (loss) per common share excludes dilution and is computed by dividing net income (loss) by the weighted average number of common shares outstanding during the period. Diluted earnings per common share reflect 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. Since the Company has only incurred losses, basic and diluted loss per share are the same. The amount of potentially dilutive securities excluded from the calculation was 14,367,021 and 6,043,876 shares of common stock underlying warrants, convertible notes and options at December 31, 2012 and 2011, respectively. Additionally, there were 145,543 shares of common stock being held in escrow at December 31, 2012 and 2011, pending the achievement of certain regulatory and sales-based milestones as part of the license agreement with ND Partners LLC. | |||||
Accounting Standards Updates | ' | ||||
ASUs not effective until after December 31, 2012 are not expected to have a significant effect on the Company’s financial position or results of operations. |
2_Summary_of_Significant_Accou2
2. Summary of Significant Accounting Policies (Tables) | 12 Months Ended | ||||
Dec. 31, 2012 | |||||
Accounting Policies [Abstract] | ' | ||||
Property, Plant and Equipment | ' | ||||
Description | Estimated Useful Life | ||||
Office equipment and furniture | 5 years | ||||
Leasehold improvements | 5 years | ||||
Computer equipment | 5 years | ||||
Computer software | 3 years | ||||
Assumptions Used in Black-Scholes Option-Pricing Model | ' | ||||
2012 | 2011 | ||||
Risk-free interest rate | 0.27% – 1.6% | 0.9% – 2.1% | |||
Expected volatility | 98% – 127% | 109% – 115% | |||
Expected life of options in years | 5 | 5 | |||
Expected dividend yield | 0.00% | 0.00% |
4_Income_Taxes_Tables
4. Income Taxes (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2012 | |||||||||
Income Tax Disclosure [Abstract] | ' | ||||||||
Deferred Tax Assets | ' | ||||||||
2012 | 2011 | ||||||||
Net operating loss carryforwards – Federal | $ | 9,561,000 | $ | 8,612,000 | |||||
Net operating loss carryforwards – state | 1,099,000 | 931,000 | |||||||
Common stock issued to licensors | 2,541,000 | 2,541,000 | |||||||
Amortization of debt discount | 142,000 | - | |||||||
Stock-based compensation | 110,000 | - | |||||||
Other | 80,000 | 80,000 | |||||||
Totals | 13,533,000 | 12,164,000 | |||||||
Less valuation allowance | (13,533,000 | ) | (12,164,000 | ) | |||||
Deferred tax assets | $ | - | $ | - | |||||
Effective Income Tax Rate Reconciliation | ' | ||||||||
December 31, | |||||||||
2012 | 2011 | ||||||||
Statutory Federal tax rate | (34.0 | )% | (34.0 | )% | |||||
State income tax rate (net of Federal) | (6.0 | )% | (6.0 | )% | |||||
Other permanent differences | 0 | % | 3.9 | % | |||||
Sale of State of New Jersey net operating losses (net of Federal) | 0 | % | (6.9 | )% | |||||
Effect of valuation allowance | 40 | % | 36.1 | % | |||||
Effective tax rate | 0 | % | (6.9 | )% |
5_Commitments_and_Contingencie1
5. Commitments and Contingencies (Tables) | 12 Months Ended | ||||
Dec. 31, 2012 | |||||
Commitments and Contingencies Disclosure [Abstract] | ' | ||||
Schedule of Future Minimum Rental Payments for Operating Leases | ' | ||||
Schedule of Future Minimum Lease Payments | |||||
Years Ending December 31, | Amount | ||||
2013 | $ | 82,697 | |||
2014 | 83,576 | ||||
2015 | 20,894 | ||||
Total | $ | 187,167 |
6_Convertible_Notes_Tables
6. Convertible Notes (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2012 | |||||||||
Convertible Notes Payable [Abstract] | ' | ||||||||
Fair Value Assumption of Warrant Issued | ' | ||||||||
September 20, | November 13, | ||||||||
2012 | 2012 | ||||||||
Contractual Term | 5 years | 5 years | |||||||
Volatility | 117.57 | % | 119.15 | % | |||||
Dividend yield | 0 | % | 0 | % | |||||
Risk-free interest rate | 0.7 | % | 0.63 | % | |||||
Senior Convertible Notes and Warrants Additional Information | ' | ||||||||
9% Senior convertible notes | $ | 664,000 | |||||||
Debt discount/beneficial conversion feature | (647,939 | ) | |||||||
Balance | $ | 16,061 | |||||||
Accrued interest | $ | 10,763 | |||||||
9% Senior convertible notes, related parties | $ | 660,000 | |||||||
Debt discount/beneficial conversion feature | (406,316 | ) | |||||||
Balance | $ | 253,684 | |||||||
Accrued interest, related parties | $ | 16,175 |
7_Stockholders_Equity_Deficien1
7. Stockholders' Equity (Deficiency) (Tables) | 12 Months Ended | ||||||||||||||||
Dec. 31, 2012 | |||||||||||||||||
STOCKHOLDERS' EQUITY (DEFICIENCY) | ' | ||||||||||||||||
Summary of Option Activity under Plan and Related Information | ' | ||||||||||||||||
Year Ended | Year Ended | ||||||||||||||||
31-Dec-12 | 31-Dec-11 | ||||||||||||||||
Shares | Weighted | Shares | Weighted | ||||||||||||||
Average | Average | ||||||||||||||||
Exercise | Exercise | ||||||||||||||||
Price | Price | ||||||||||||||||
Outstanding at beginning of year | 1,236,342 | $ | 2.47 | 1,662,827 | $ | 3.15 | |||||||||||
Granted | 1,380,000 | $ | 0.56 | 886,000 | $ | 1.67 | |||||||||||
Cancelled | (217,662 | ) | $ | 3.13 | - | $ | - | ||||||||||
Forfeited | (263,050 | ) | $ | 1.72 | (1,312,485 | ) | $ | 2.79 | |||||||||
Outstanding at end of year | 2,135,630 | $ | 1.26 | 1,236,342 | $ | 2.47 | |||||||||||
Outstanding at end of year expected to vest | 961,034 | $ | 1.26 | 1,236,342 | $ | 2.47 | |||||||||||
Options exercisable | 758,297 | $ | 2.16 | 476,014 | $ | 3.02 | |||||||||||
Weighted-average fair value of options granted during the year | $ | 0.46 | $ | 1.33 | |||||||||||||
Summary of warrants outstanding | ' | ||||||||||||||||
Number of | Exercise | Expiration | |||||||||||||||
Warrants | Price | Date | |||||||||||||||
Issued to various consultants | 17,869 | $ | 10.66 | 1/30/13 | |||||||||||||
Issued to co-placement agents in connection with previous | 18,250 | 7.84 | |||||||||||||||
convertible note financings | 10/29/14 | ||||||||||||||||
Issued in connection with 2009 private placement | 503,034 | 3.4375 | 10/29/14 | ||||||||||||||
Issued in connection with IPO | 4,263,569 | 3.4375 | 3/24/15 | ||||||||||||||
Issued to IPO underwriters that, if exercised, would result in the | 4,812 | 3.9 | |||||||||||||||
issuance of an additional 4,812 shares of common stock and | |||||||||||||||||
warrants to purchase an additional 2,406 shares of common | |||||||||||||||||
stock | 3/24/15 | ||||||||||||||||
Issued in connection with September 20, 2012 private placement | 2,125,000 | 0.4 | |||||||||||||||
of convertible notes | 9/20/17 | ||||||||||||||||
Issued to placement agent in connection with September 20, | 212,500 | 0.4 | |||||||||||||||
2012 private placement of convertible notes | 9/20/17 | ||||||||||||||||
Issued in connection with November 13, 2012 private placement | 1,185,000 | 0.4 | |||||||||||||||
of convertible notes | 11/13/17 | ||||||||||||||||
Issued to placement agent in connection with November 13, | 118,500 | 0.4 | |||||||||||||||
2012 private placement of convertible notes | 11/13/17 | ||||||||||||||||
Total warrants outstanding at December 31, 2012 | 8,448,534 |
12_Restatement_of_Consolidated1
12. Restatement of Consolidated Financial Statements (Tables) | 12 Months Ended | ||||||||||||||||||||||||
Dec. 31, 2012 | |||||||||||||||||||||||||
Restatement Of Consolidated Financial Statements Tables | ' | ||||||||||||||||||||||||
Schedule of restatements | ' | ||||||||||||||||||||||||
Cumulative Period from July 28, 2006 (Inception) Through December 31, 2012 | |||||||||||||||||||||||||
31-Dec-12 | 31-Dec-11 | ||||||||||||||||||||||||
As Previously | As Previously | As Previously | |||||||||||||||||||||||
Reported | As Restated | Reported | As Restated | Reported | As Restated | ||||||||||||||||||||
($) | ($) | ($) | ($) | ($) | ($) | ||||||||||||||||||||
Balance Sheets: | |||||||||||||||||||||||||
Accounts payable | 1,023,553 | 928,553 | 1,008,493 | 913,493 | - | - | |||||||||||||||||||
Accrued expense | 306,983 | 261,983 | - | - | - | - | |||||||||||||||||||
Total current liabilities | 1,616,456 | 1,476,456 | 1,305,005 | 1,210,005 | - | - | |||||||||||||||||||
Total Liabilities | 1,628,641 | 1,488,641 | 1,319,477 | 1,224,477 | - | - | |||||||||||||||||||
Deficit accumulated during | (46,373,234 | ) | (46,233,234 | ) | (42,947,552 | ) | (42,852,552 | ) | - | - | |||||||||||||||
the development stage | |||||||||||||||||||||||||
Total Stockholders’ Equity | (475,376 | ) | (335,376 | ) | 1,236,528 | 1,331,528 | - | - | |||||||||||||||||
(Deficiency) | |||||||||||||||||||||||||
Statement of Operations: | |||||||||||||||||||||||||
Research and development | 1,187,631 | 1,142,631 | 4,098,225 | 4,058,225 | 23,343,305 | 23,203,305 | |||||||||||||||||||
Total Operating Expenses | 3,044,711 | 2,999,711 | 7,246,984 | 7,206,984 | 36,119,339 | 35,979,339 | |||||||||||||||||||
Loss from Operations | (3,044,711 | ) | (2,999,711 | ) | (7,246,984 | ) | (7,206,984 | ) | (36,119,339 | ) | (35,979,339 | ) | |||||||||||||
Loss Before Income Taxes | (3,425,682 | ) | (3,380,682 | ) | (7,205,128 | ) | (7,165,128 | ) | (47,148,009 | ) | (47,008,009 | ) | |||||||||||||
Net Loss | (3,425,682 | ) | (3,380,682 | ) | (6,711,273 | ) | (6,671,273 | ) | (46,373,234 | ) | (46,233,234 | ) | |||||||||||||
Net Loss per Common Share | |||||||||||||||||||||||||
Basic and Diluted | (0.30 | ) | (0.30 | ) | (0.59 | ) | (0.58 | ) | - | - | |||||||||||||||
Statement of Cash Flows: | |||||||||||||||||||||||||
Net loss | (3,425,682 | ) | (3,380,682 | ) | (6,711,273 | ) | (6,671,273 | ) | (46,373,234 | ) | (46,233,234 | ) | |||||||||||||
Accounts payable | - | - | (130,783 | ) | (170,783 | ) | 992,750 | 897,750 | |||||||||||||||||
Accrued expenses and accrued | 26,646 | (18,354 | ) | - | - | 323,158 | 278,158 | ||||||||||||||||||
interest | |||||||||||||||||||||||||
Deficit Accumulated During the Development Stage | Total Stockholders’ Equity (Deficiency) | ||||||||||||||||||||||||
As Previously | As Previously | ||||||||||||||||||||||||
Reported | As Restated | Reported | As Restated | ||||||||||||||||||||||
($) | ($) | ($) | ($) | ||||||||||||||||||||||
Statement of Stockholders’ Equity | |||||||||||||||||||||||||
(Deficiency): | |||||||||||||||||||||||||
Net loss | (8,121,455 | ) | (8,096,455 | ) | - | - | |||||||||||||||||||
Balance December 31, 2009 | (25,331,043 | ) | (25,306,043 | ) | (14,708,899 | ) | (14,683,899 | ) | |||||||||||||||||
Net loss | (10,905,236 | ) | (10,875,236 | ) | - | - | |||||||||||||||||||
Balance December 31, 2010 | (36,236,279 | ) | (36,181,279 | ) | 7,255,398 | 7,310,398 | |||||||||||||||||||
Net loss | (6,711,273 | ) | (6,671,273 | ) | - | - | |||||||||||||||||||
Balance December 31, 2011 | (42,947,552 | ) | (42,852,552 | ) | 1,236,528 | 1,331,528 | |||||||||||||||||||
Net loss | (3,425,682 | ) | (3,380,682 | ) | - | - | |||||||||||||||||||
Balance December 31, 2012 | (46,373,234 | ) | (46,233,234 | ) | (475,376 | ) | (335,376 | ) | |||||||||||||||||
2_Summary_of_Significant_Accou3
2. Summary of Significant Accounting Policies (Details) | 12 Months Ended |
Dec. 31, 2012 | |
Office equipment and furniture | ' |
Estimated useful life | '5 years |
Leasehold improvements | ' |
Estimated useful life | '5 years |
Computer Equipment | ' |
Estimated useful life | '5 years |
Computer Software | ' |
Estimated useful life | '3 years |
2_Summary_of_Significant_Accou4
2. Summary of Significant Accounting Policies (Details 1) | 12 Months Ended | |
Dec. 31, 2012 | Dec. 31, 2011 | |
Summary Of Significant Accounting Policies Details 1 | ' | ' |
Risk-free interest rate, min | 0.27% | 0.90% |
Risk-free interest rate, max | 1.60% | 2.10% |
Expected volatility, min | 98.00% | 109.00% |
Expected volatility, max | 127.00% | 115.00% |
Expected life of options in years | '5 years | '5 years |
Expected dividend yield | 0.00% | 0.00% |
4_Income_Taxes_Details
4. Income Taxes (Details) (USD $) | Dec. 31, 2012 | Dec. 31, 2011 |
Income Taxes Details | ' | ' |
Net operating loss carryforwardsB bB Federal | $9,561,000 | $8,612,000 |
Net operating loss carryforwardsB bB state | 1,099,000 | 931,000 |
Common stock issued to licensors | 2,541,000 | 2,541,000 |
Amortization of debt discount | 142,000 | ' |
Stock-based compensation | 110,000 | ' |
Other | 80,000 | 80,000 |
Totals | 13,533,000 | 12,164,000 |
Less valuation allowance | -13,533,000 | -12,164,000 |
Deferred tax assets | $0 | $0 |
4_Income_Taxes_Details_1
4. Income Taxes (Details 1) | 12 Months Ended | |
Dec. 31, 2012 | Dec. 31, 2011 | |
Income Taxes Details 1 | ' | ' |
Statutory Federal tax rate | -34.00% | -34.00% |
State income tax rate (net of Federal) | -6.00% | -6.00% |
Other permanent differences | 0.00% | 3.90% |
Sale of State of New Jersey net operating losses (net of Federal) | 0.00% | -6.90% |
Effect of valuation allowance | 40.00% | 36.10% |
Effective tax rate | 0.00% | -6.90% |
5_Commitments_and_Contingencie2
5. Commitments and Contingencies (Details) (USD $) | Dec. 31, 2012 |
Commitments And Contingencies Details | ' |
2013 | $82,697 |
2014 | 83,576 |
2015 | 20,894 |
Total | $187,167 |
6_Convertible_Notes_Details
6. Convertible Notes (Details) | 0 Months Ended | 1 Months Ended |
Nov. 30, 2012 | Sep. 20, 2012 | |
Convertible Notes Details | ' | ' |
Contractual Term | '5 years | '5 years |
Volatility | 119.15% | 117.57% |
Dividend yield | 0.00% | 0.00% |
Risk-free interest rate | 0.63% | 0.70% |
6_Convertible_Notes_Details_1
6. Convertible Notes (Details 1) (USD $) | Dec. 31, 2012 | Dec. 31, 2011 |
Convertible Notes Details 1 | ' | ' |
9% Senior convertible notes | $664,000 | ' |
Debt discount/beneficial conversion feature | -647,939 | ' |
Balance | 16,061 | ' |
Accrued interest | 10,763 | ' |
9% Senior convertible notes, related parties | 660,000 | ' |
Debt discount/beneficial conversion feature | -406,316 | ' |
Balance | 253,684 | ' |
Accrued interest, related parties | $16,175 | ' |
7_Stockholders_Equity_Deficien2
7. Stockholders' Equity (Deficiency) (Details) (USD $) | 12 Months Ended | |
Dec. 31, 2012 | Dec. 31, 2011 | |
Stockholders Equity Deficiency Details | ' | ' |
Outstanding | 1,236,342 | 1,662,827 |
Granted | 1,380,000 | 886,000 |
Cancelled | -217,662 | ' |
Forfeited | -263,050 | -1,312,485 |
Outstanding | 2,135,630 | 1,236,342 |
Shares vested and expected to vest | 961,034 | 1,236,342 |
Exercisable | 758,297 | 476,014 |
Outstanding | $2.47 | $3.15 |
Granted | $0.56 | $1.67 |
Exercised | $3.13 | ' |
Cancelled/forfeited | $1.72 | $2.79 |
Outstanding | $1.26 | $2.47 |
Shares vested and expected to vest | $1.26 | $2.47 |
Exercisable | $2.16 | $3.02 |
7_Stockholders_Equity_Deficien3
7. Stockholders' Equity (Deficiency) (Details 1) (USD $) | Dec. 31, 2012 |
Number of warrants | 8,448,534 |
Warrant 1 | ' |
Number of warrants | 17,869 |
Exercise Price | 10.66 |
Expiration Date | '1/30/2013 |
Warrant 2 | ' |
Number of warrants | 18,250 |
Exercise Price | 7.84 |
Expiration Date | '10/29/2014 |
Warrant 3 | ' |
Number of warrants | 503,034 |
Exercise Price | 3.4375 |
Expiration Date | '10/29/2014 |
Warrant 4 | ' |
Number of warrants | 4,263,569 |
Exercise Price | 3.4375 |
Expiration Date | '3/24/2015 |
Warrant 5 | ' |
Number of warrants | 4,812 |
Exercise Price | 3.9 |
Expiration Date | '3/24/2015 |
Warrant 6 | ' |
Number of warrants | 2,125,000 |
Exercise Price | 0.4 |
Expiration Date | '9/20/2017 |
Warrant 7 | ' |
Number of warrants | 212,500 |
Exercise Price | 0.4 |
Expiration Date | '9/20/2017 |
Warrant 8 | ' |
Number of warrants | 1,185,000 |
Exercise Price | 0.4 |
Expiration Date | '11/13/2017 |
Warrant 9 | ' |
Number of warrants | 118,500 |
Exercise Price | 0.4 |
Expiration Date | '11/13/2017 |
12_Restatement_of_Consolidated2
12. Restatement of Consolidated Financial Statements (Details) (USD $) | Dec. 31, 2012 | Dec. 31, 2011 |
Balance Sheets: | ' | ' |
Accounts payable | $928,553 | $913,493 |
Accrued expense | 261,983 | 296,512 |
Total current liabilities | 1,476,456 | 1,210,005 |
Total Liabilities | 1,488,641 | 1,224,477 |
Deficit accumulated during the development stage | 46,233,234 | 42,852,552 |
Total Stockholdersb Equity (Deficiency) | -335,376 | 1,331,528 |
As Previously Reported | ' | ' |
Balance Sheets: | ' | ' |
Accounts payable | 1,023,553 | 1,008,493 |
Accrued expense | 306,983 | ' |
Total current liabilities | 1,616,456 | 1,305,005 |
Total Liabilities | 1,628,641 | 1,319,477 |
Deficit accumulated during the development stage | -46,373,234 | -42,947,552 |
Total Stockholdersb Equity (Deficiency) | -475,376 | 1,236,528 |
As Restated | ' | ' |
Balance Sheets: | ' | ' |
Accounts payable | 928,553 | 913,493 |
Accrued expense | 261,983 | ' |
Total current liabilities | 1,476,456 | 1,210,005 |
Total Liabilities | 1,488,641 | 1,224,477 |
Deficit accumulated during the development stage | -46,233,234 | -42,852,552 |
Total Stockholdersb Equity (Deficiency) | ($335,376) | $1,331,528 |
12_Restatement_of_Consolidated3
12. Restatement of Consolidated Financial Statements (Details 1) (USD $) | 12 Months Ended | 77 Months Ended | |
Dec. 31, 2012 | Dec. 31, 2011 | Dec. 31, 2012 | |
Statement of Operations: | ' | ' | ' |
Research and development | $1,142,631 | $4,058,225 | $23,203,305 |
Total Operating Expenses | 2,999,711 | 7,206,984 | 35,979,339 |
Loss from Operations | -2,999,711 | -7,206,984 | -35,979,339 |
Loss Before Income Taxes | -3,380,682 | -7,165,128 | -47,008,009 |
Net Loss | -3,380,682 | -6,671,273 | -46,233,234 |
Net Loss Per Common Share Basic and Diluted | ($0.30) | ($0.58) | ' |
Statement of Cash Flows: | ' | ' | ' |
Net loss | -3,380,682 | -6,671,273 | -46,233,234 |
Accounts payable | -15,743 | -170,783 | 897,750 |
As Previously Reported | ' | ' | ' |
Statement of Operations: | ' | ' | ' |
Research and development | 1,187,631 | 4,098,225 | 23,343,305 |
Total Operating Expenses | 3,044,711 | 7,246,984 | 36,119,339 |
Loss from Operations | -3,044,711 | -7,246,984 | -36,119,339 |
Loss Before Income Taxes | -3,425,682 | -7,205,128 | -47,148,009 |
Net Loss | -3,425,682 | -6,711,273 | -46,373,234 |
Net Loss Per Common Share Basic and Diluted | ($0.30) | ($0.59) | ' |
Statement of Cash Flows: | ' | ' | ' |
Net loss | -3,425,682 | -6,711,273 | -46,373,234 |
Accounts payable | ' | -130,783 | 992,750 |
Accrued expenses and accrued interest | 26,646 | ' | 323,158 |
As Restated | ' | ' | ' |
Statement of Operations: | ' | ' | ' |
Research and development | 1,142,631 | 4,058,225 | 23,203,305 |
Total Operating Expenses | 2,999,711 | 7,206,984 | 35,979,339 |
Loss from Operations | -2,999,711 | -7,206,984 | -35,979,339 |
Loss Before Income Taxes | -3,380,682 | -7,165,128 | -47,008,009 |
Net Loss | -3,380,682 | -6,671,273 | -46,233,234 |
Net Loss Per Common Share Basic and Diluted | ($0.30) | ($0.58) | ' |
Statement of Cash Flows: | ' | ' | ' |
Net loss | -3,380,682 | -6,671,273 | -46,233,234 |
Accounts payable | ' | -170,783 | 897,750 |
Accrued expenses and accrued interest | ($18,354) | ' | $278,158 |