Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2016 | Jul. 29, 2016 | |
Document and Entity Information [Abstract] | ||
Entity Registrant Name | CYTRX CORP | |
Entity Central Index Key | 799,698 | |
Current Fiscal Year End Date | --12-31 | |
Entity Well-known Seasoned Issuer | No | |
Entity Voluntary Filers | No | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 96,943,072 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q2 | |
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2016 |
CONDENSED BALANCE SHEETS (Unaud
CONDENSED BALANCE SHEETS (Unaudited) - USD ($) | Jun. 30, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 55,913,199 | $ 22,261,372 |
Short-term investments | 0 | 35,035,420 |
Receivables | 224,702 | 4,621,605 |
Prepaid expenses and other current assets | 1,337,068 | 2,373,708 |
Total current assets | 57,474,969 | 64,292,105 |
Equipment and furnishings, net | 1,990,334 | 1,467,681 |
Goodwill | 183,780 | 183,780 |
Other assets | 685,385 | 1,080,872 |
Total assets | 60,334,468 | 67,024,438 |
Current liabilities: | ||
Accounts payable | 7,293,498 | 8,058,624 |
Accrued expenses and other current liabilities | 5,395,495 | 9,693,359 |
Non-cash litigation settlement due in shares of common stock | 700,000 | 4,500,000 |
Warrant liability | 0 | 693,457 |
Term loan, net - current | 1,716,265 | 0 |
Total current liabilities | 15,105,258 | 22,945,440 |
Long term loan, net: | 21,870,212 | 0 |
Total liabilities | 36,975,470 | 22,945,440 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred Stock, $0.01 par value, 5,000,000 shares authorized, including 25,000 shares of Series A Junior Participating Preferred Stock; no shares issued and outstanding | 0 | 0 |
Common stock, $0.001 par value, 250,000,000 shares authorized; 68,371,643 shares issued and outstanding at June 30, 2016; 66,480,065 shares issued and outstanding at December 31, 2015 | 68,371 | 66,480 |
Additional paid-in capital | 419,308,736 | 409,107,292 |
Accumulated deficit | (396,018,109) | (365,094,774) |
Total stockholders' equity | 23,358,998 | 44,078,998 |
Total liabilities and stockholders' equity | $ 60,334,468 | $ 67,024,438 |
CONDENSED BALANCE SHEETS (Unau3
CONDENSED BALANCE SHEETS (Unaudited) (Parenthetical) - $ / shares | Jun. 30, 2016 | Dec. 31, 2015 |
Stockholders' equity: | ||
Preferred Stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred Stock, shares authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred Stock, shares issued (in shares) | 0 | 0 |
Preferred Stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 250,000,000 | 250,000,000 |
Common stock, shares issued (in shares) | 68,371,643 | 66,480,065 |
Common stock, shares outstanding (in shares) | 68,371,643 | 66,480,065 |
Series A Junior Participating Preferred Stock [Member] | ||
Stockholders' equity: | ||
Preferred Stock, shares authorized (in shares) | 25,000 | 25,000 |
CONDENSED STATEMENTS OF OPERATI
CONDENSED STATEMENTS OF OPERATIONS (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Revenue: | ||||
License revenue | $ 100,000 | $ 0 | $ 100,000 | $ 0 |
Expenses: | ||||
Research and development | 12,452,340 | 10,008,304 | 20,604,559 | 22,573,181 |
General and administrative | 6,128,904 | 4,191,769 | 10,087,340 | 7,322,001 |
Total expenses | 18,581,244 | 14,200,073 | 30,691,899 | 29,895,182 |
Loss before other income (loss) | (18,481,244) | (14,200,073) | (30,591,899) | (29,895,182) |
Other income (loss): | ||||
Interest income | 65,436 | 46,455 | 127,174 | 103,029 |
Interest expense | (741,346) | 0 | (1,158,148) | 0 |
Other income (loss), net | (798) | 30,660 | 6,081 | 15,940 |
Gain on warrant derivative liability | 877,729 | 2,435,865 | 693,457 | 564,570 |
Net loss | $ (18,280,223) | $ (11,687,093) | $ (30,923,335) | $ (29,211,643) |
Basic and diluted loss per share (in dollars per share) | $ (0.27) | $ (0.21) | $ (0.46) | $ (0.52) |
Basic and diluted weighted-average shares outstanding (in shares) | 67,398,837 | 55,726,432 | 66,893,846 | 55,724,581 |
CONDENSED STATEMENTS OF CASH FL
CONDENSED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Cash flows from operating activities: | ||
Net loss | $ (30,923,335) | $ (29,211,643) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 213,964 | 165,830 |
Stock-based compensation expense | 4,364,886 | 3,662,708 |
Fair value adjustment on warrant liability | (693,457) | (564,570) |
Non-cash litigation settlement due in common stock | 700,000 | 0 |
Amortization of loan cost and discount | 208,148 | 0 |
Loss on retirement of fixed assets | 3,388 | 0 |
Changes in assets and liabilities: | ||
Receivables | 4,368,773 | (3,155,714) |
Interest receivable | 28,130 | 90,431 |
Prepaid expenses and other current assets | 1,432,127 | 2,027,993 |
Accounts payable | (844,373) | (1,332,633) |
Accrued expenses and other current liabilities | (4,297,864) | 4,382,343 |
Net cash used in operating activities | (25,439,613) | (23,935,255) |
Cash flows from investing activities: | ||
Purchase of short-term investments | 0 | (17,960,256) |
Proceeds from the sale of short-term investments | 35,035,420 | 48,579,636 |
Purchases of equipment and furnishings | (660,758) | (69,294) |
Net cash provided by investing activities | 34,374,662 | 30,550,086 |
Cash flows from financing activities: | ||
Proceeds from term loan, net | 24,012,078 | 0 |
Net proceeds from exercise of warrants and stock options | 704,700 | 0 |
Net cash provided by financing activities | 24,716,778 | 0 |
Net increase in cash and cash equivalents | 33,651,827 | 6,614,831 |
Cash and cash equivalents at beginning of period | 22,261,372 | 32,218,905 |
Cash and cash equivalents at end of period | 55,913,199 | 38,833,736 |
Supplemental disclosure of cash flow information: | ||
Cash paid during the year for interest | 752,083 | 0 |
Cashless warrant exercises | 0 | 3 |
Cash paid for income taxes | 800 | 800 |
Supplemental disclosure of non-cash investing activities: | ||
Warrants issued in connection with term loan | 633,749 | 0 |
Equipment and furnishings purchased on credit | 79,247 | 5,022 |
Shares issued in connection with the class action settlement | $ 4,500,000 | $ 0 |
Description of Company and Basi
Description of Company and Basis of Presentation | 6 Months Ended |
Jun. 30, 2016 | |
Description of Company and Basis of Presentation [Abstract] | |
Description of Company and Basis of Presentation | 1. Description of Company and Basis of Presentation CytRx Corporation ("we," "us," "our" or the "Company") is a biopharmaceutical research and development company specializing in oncology. We currently are focused on the clinical development of aldoxorubicin (formerly known as INNO-206), our modified version of the widely-used chemotherapeutic agent, doxorubicin. at utilize our Linker Activated Drug Release ( TM ) technology. We recently announced an analysis from our on-going global, randomized Phase 3 clinical trial of aldoxorubicin as a treatment for patients with relapsed or refractory soft tissue sarcomas, or STS. The trial enrolled 433 patients at 79 sites in 15 countries including the U.S. and Canada. The current evaluation did not show a statistically significant difference between aldoxorubicin and investigator's choice therapy for the primary endpoint of progression-free survival, or PFS, with a median of 4.17 months and 4.04 months, respectively (hazard ratio: 0.91). The objective response rate (ORR), which measures tumor shrinkage, and disease control rate (ORR + stable disease ³ 4 months), showed a near doubling in the aldoxorubicin arm compared to investigator's choice, including in patients who previously received treatment with doxorubicin. Disease control rate for aldoxorubicin was significantly greater than investigator's choice therapy in the intent-to-treat population (p=0.048) as well as in patients who received prior doxorubicin (p=0.0415). Patients continue to be followed for overall survival (OS), a secondary endpoint of the trial. We are currently evaluating aldoxorubicin in a global Phase 2b clinical trial in second-line small cell lung cancer, a Phase 1b trial in combination with ifosfamide in patients with soft tissue sarcoma, and a Phase 1b trial in combination with gemcitabine in subjects with metastatic solid tumors. We have completed Phase 2 clinical trials of aldoxorubicin in patients with late-stage glioblastoma (brain cancer) and HIV-related Kaposi's Sarcoma, a Phase 1b clinical trial of aldoxorubicin in combination with doxorubicin in patients with advanced solid tumors and a Phase 1b pharmacokinetics clinical trial of aldoxorubicin in patients with metastatic solid tumors. In addition to aldoxorubicin, we are currently completing pre-clinical development for DK049, a novel anti-cancer drug conjugate that utilizes our TM technology. DK049 was created at our laboratory facility in Freiburg, Germany, and employs a proprietary linker that is both pH sensitive and requires a specific enzyme for the release of the cytotoxic payload. DK049 has demonstrated significant anti-tumor activity in multiple animal models implanted with human tumors, including non-small cell lung, ovarian and pancreatic cancers. We anticipate filing an Investigational New Drug Application (IND) in 2017. We plan to expand our pipeline of oncology candidates utilizing our TM technology. This technology allows for targeting to the tumor either by albumin or antibodies and can deliver anti-cancer agents that are 10-1000 times more potent than traditional chemotherapies. The accompanying condensed financial statements at June 30, 2016 and for the three-month and six-month periods ended June 30, 2016 and 2015, respectively, are unaudited, but include all adjustments, consisting of normal recurring entries, that management believes to be necessary for a fair presentation of the periods presented. Interim results are not necessarily indicative of results for a full year. Balance sheet amounts as of December 31, 2015 have been derived from the our audited financial statements as of that date. The financial statements included herein have been prepared by us pursuant to the rules and regulations of the Securities and Exchange Commission ("SEC"). Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been condensed or omitted pursuant to such rules and regulations. The financial statements should be read in conjunction with the Company's audited financial statements contained in its Annual Report on Form 10-K for the year ended December 31, 2015. Following our announcement of the analysis of our on-going global Phase 3 clinical trial of aldoxorubicin, we have taken measures to reduce our burn rate and have decreased our head count and stopped our pre-commercialization activities for the present time. For this reason and others, our operating results will fluctuate for the foreseeable future. Therefore, period-to-period comparisons should not be relied upon as predictive of the results in future periods. |
Recent Accounting Pronouncement
Recent Accounting Pronouncements | 6 Months Ended |
Jun. 30, 2016 | |
Recent Accounting Pronouncements [Abstract] | |
Recent Accounting Pronouncements | 2. Recent Accounting Pronouncements In March 2016, the FASB issued Accounting Standards Update 2016-09, Compensation—Stock Compensation In February 2016, the FASB issued Accounting Standards Update 2016-02, Leases In January 2016, the FASB issued Accounting Standards Update 2016-01, Recognition and Measurement of Financial Assets and Financial Liabilities In April 2015, the FASB issued ASU No. 2015-03, Simplifying the Presentation of Debt Issuance Costs In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements – Going Concern ("Subtopic 205-40") |
Foreign Currency Remeasurement
Foreign Currency Remeasurement | 6 Months Ended |
Jun. 30, 2016 | |
Foreign Currency Remeasurement [Abstract] | |
Foreign Currency Remeasurement | 3. Foreign Currency Remeasurement The U.S. dollar has been determined to be the functional currency for the net assets of the Company's laboratory facility in Germany. Transactions are recorded in the local currencies and are remeasured at each reporting date using the historical rates for nonmonetary assets and liabilities and exchange rates for monetary assets and liabilities at the balance sheet date. Exchange gains and losses from the remeasurement of monetary assets and liabilities are recognized in other income (loss). The Company recognized a gain of approximately $600 and $5,800, respectively, for the three-month and six-month periods ended June 30, 2016 and a gain of approximately $5,000 and a loss of approximately $10,700 for the three and six-month periods ended June 30, 2015, respectively. |
Short-term Investment
Short-term Investment | 6 Months Ended |
Jun. 30, 2016 | |
Short-term Investment [Abstract] | |
Short-term Investment | 4 . Short-term Investment The Company held no short-term investments at June 30, 2016, as compared to $35.0 million at December 31, 2015. The Company classified these investments as available for sale at December 31, 2015. |
Non-Cash Litigation Settlement
Non-Cash Litigation Settlement Due in Shares of Common Stock | 6 Months Ended |
Jun. 30, 2016 | |
Non-Cash Litigation Settlement Due in Shares of Common Stock [Abstract] | |
Non-Cash Litigation Settlement Due in Shares of Common Stock | 5. Non-Cash Litigation Settlement Due in Shares of Common Stock On January 5, 2016, we announced that we had reached an agreement to settle the consolidated stockholder derivative lawsuits, In Re CytRx Corporation Stockholder Derivative Litigation Distinguishing Liabilities from Equity, The settlement and award of attorneys' fees and expenses are subject to definitive documentation, notice to stockholders, and District Court approval. A hearing on the Motion for Preliminary Approval is scheduled for July 25, 2016. On July 20, 2016, the Court vacated the July 25 hearing date on the motion to set aside the judgment and the motion to intervene and took both matters under submission. On December 10, 2015, we announced that we had reached an agreement to settle the Federal Class Action and filed a Stipulation of Settlement with the Court. As part of the settlement agreement, we will issue the equivalent number of shares of our common stock to the class of a non-cash amount of $4,500,000 worth at the prevailing stock price at the time of the Court's final approval of the settlement agreement, but not less than a minimum of 1,200,000 shares and not more than a maximum of 1,800,000 shares. In accordance with ASC 480, " Distinguishing Liabilities from Equity," |
Term Loan
Term Loan | 6 Months Ended |
Jun. 30, 2016 | |
Term Loan [Abstract] | |
Term Loan | 6. Term Loan On February 5, 2016, we entered into a loan and security agreement with Hercules Technology Growth Capital, Inc. ("HTGC"), as administrative agent and lender, and Hercules Technology III, L.P., as lender, pursuant to which the lenders made a long-term loan in an aggregate principal amount of up to $40 million, subject to certain conditions. The lenders made an initial term loan to the Company on February 8, 2016 in the aggregate principal amount of $25 million. The term loan bears interest at the daily variable rate per annum equal to 6.00% plus the prime rate, or 9.5%, whichever is greater. We are required to make interest-only payments on the term loans through February 28, 2017, and beginning on March 1, 2017 we will be required to make amortizing payments of principal and accrued interest in equal monthly installments until the maturity date of the loan. Under the terms of the loan, we are required to maintain a minimum cash balance equal to the greater of (i) $10 million or (ii) forward three months projected cash burn. If we achieve certain milestones, we may request an additional term loan in an aggregate principal amount of up to $15 million no later than December 31, 2016, or such later date that HTGC otherwise determines in its sole discretion. We do not expect to meet these milestones at this time. In connection with the loan and security agreement, we issued to the lenders warrants to purchase a total of 634,146 shares of our common stock at an exercise price of $2.05. These warrants are classified on the June 30, 2016 balance sheet as equity warrants with a fair value of $633,749 determined at the date of issuance. All outstanding principal and accrued interest on the term loans will be due and payable in full on the maturity date of February 1, 2020. As security for our obligations under the loan and securities agreement, we granted HTGC, as administrative agent, a security interest in substantially all of our existing and after-acquired assets except for our intellectual property and certain other excluded assets. The following sets forth information regarding the current and long-term portion of the loan: June 30, 2016 Term Loan Principal - Current $ 2,441,277 Issuance Cost - Current (119,189 ) Loan Discount - Current (605,823 ) Term Loan, Net - Current $ 1,716,265 Term Loan Principal $ 22,558,723 End Fee Payable 1,771,250 Long Term Issuance Cost (385,955 ) Long Term Loan Discount (2,073,806 ) Long Term Loan, Net $ 21,870,212 The interest expense on the loan for the three-month and six-month periods ended June 30, 2016 was $741,346 and $1,158,148, respectively. There was no loan expense in the 2015 comparative periods. |
Basic and Diluted Net Loss Per
Basic and Diluted Net Loss Per Common Share | 6 Months Ended |
Jun. 30, 2016 | |
Basic and Diluted Net Loss Per Common Share [Abstract] | |
Basic and Diluted Net Loss Per Common Share | 7. Basic and Diluted Net Loss Per Common Share Basic and diluted net loss per common share is computed based on the weighted-average number of common shares outstanding. Common share equivalents (which consist of optionsand warrants) are excluded from the computation of diluted net loss per common share where the effect would be anti-dilutive. Common share equivalents that could potentially dilute net loss per share in the future, and which were excluded from the computation of diluted loss per share, totaled 22.4 million shares for each of the three-month and six-month periods ended June 30, 2016, and 17.8 million shares for each of the three-month and six-month periods ended June 30, 2015 . |
Warrant Liabilities
Warrant Liabilities | 6 Months Ended |
Jun. 30, 2016 | |
Warrant Liabilities [Abstract] | |
Warrant Liabilities | 8. Warrant Liabilities Liabilities measured at fair value on a recurring basis include warrant liabilities resulting from our equity financings. In accordance with ASC 815-40 , Derivatives and Hedging – Contracts in Entity's Own Equity Equity-Based Payments to Non-Employees Six Months Ended June 30, 2016 2015 Risk-free interest rate 0.20 % 0.28 % Expected dividend yield 0 % 0 % Expected lives 0.09 1.09 Expected volatility 59.3 % 62.7 % Warrants classified as liabilities (in shares) 6,371,854 6,371,854 Our computation of expected volatility is based on the historical daily volatility of its publicly traded stock. The dividend yield assumption of zero is based upon the fact that we have never paid cash dividends and presently have no intention to do so. The risk-free interest rate used for each warrant classified as a derivative is equal to the U.S. Treasury rates in effect at June 30 of each year presented. The expected lives are based on the remaining contractual lives of the related warrants at the valuation date. On August 1, 2016, these warrants expire. |
Stock Based Compensation
Stock Based Compensation | 6 Months Ended |
Jun. 30, 2016 | |
Stock Based Compensation [Abstract] | |
Stock Based Compensation | 9 . Stock Based Compensation We have a 2000 Long-Term Incentive Plan, which expired on August 6, 2010. As of June 30, 2016, there were approximately 0.6 million shares subject to outstanding stock options under this plan. No further shares are available for future grant under this plan. We also have a 2008 Stock Incentive Plan. As of June 30, 2016, there were 14.0 million shares subject to outstanding stock options and 5.9 million shares available for future grant under this plan. On July 12, 2016, our shareholders voted to amend the 2008 Stock Incentive Plan increasing the number of common shares available for future grant by 10 million shares. We follow ASC 718, Compensation-Stock Compensation, For stock options and stock warrants paid in consideration of services rendered by non-employees, we recognize compensation expense in accordance with the requirements of ASC 505-50. Non-employee option grants that do not vest immediately upon grant are recorded as an expense over the vesting period. At the end of each financial reporting period, the value of these options, as calculated using the Black-Scholes option-pricing model, is determined, and compensation expense recognized or recovered during the period is adjusted accordingly. As a result, the amount of the future compensation expense is subject to adjustment until the common stock options are fully vested. The following table sets forth the total stock-based compensation expense resulting from stock options and warrants included in our Condensed Statements of Operations: Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Research and development — employee $ 507,195 $ 392,842 $ 988,006 $ 728,780 General and administrative — employee 2,499,368 1,744,440 3,156,418 2,699,844 Total employee stock-based compensation $ 3,006,563 $ 2,137,282 $ 4,144,424 $ 3,428,624 Research and development — non-employee $ — $ — $ — $ — General and administrative — non-employee 32,506 140,533 220,462 234,084 Total non-employee stock-based compensation $ 32,506 $ 140,533 $ 220,462 $ 234,084 During the six-month period ended June 30, 2016, we granted stock options to purchase 425,000 shares of its common stock and warrants to purchase 500,000 shares of our common stock at a average weighted exercise price of $1.74. In the three-month period ended June 30, 2016, we amended the terms of stock options of a former executive in respect of a Retirement Agreement, resulting in a one-time expense of approximately $1.9 million. During the six-month period ended June 30, 2015, we granted stock options to purchase 550,000 shares of our common stock. The fair value of the stock options was estimated using the Black-Scholes option-pricing model, based on the following assumptions: Six Months Ended June 30, 2016 Six Months Ended June 30, 2015 Risk-free interest rate 1.47 % 2.21 % Expected volatility 76.3 % 78.2% - 84.4 % Expected lives (years) 5 - 10 6 - 10 Expected dividend yield 0.00 % 0.00 % Our computation of expected volatility is based on the historical daily volatility of our publicly traded stock. We use historical information to compute expected lives. In the six-month period ended June 30, 2016, the contractual term of the options granted was ten years. The dividend yield assumption of zero is based upon the fact we have never paid cash dividends and presently have no intention to do so. The risk-free interest rate used for each grant and issuance is equal to the U.S. Treasury rates in effect at the time of the grant and issuance for instruments with a similar expected life. Based on historical experience, for the six-month periods ended June 30, 2016 and 2015, we estimated annualized forfeiture rates of 10% for options granted to our employees, 2% for options granted to senior management and 0% for options granted to directors and non-employees and for warrants issued to non-employees Compensation costs will be adjusted for future changes in estimated forfeitures. We will record additional expense if the actual forfeitures are lower than estimated and will record a recovery of prior expense if the actual forfeiture rates are higher than estimated. As of June 30, 2016, there remained approximately $12.3 million of unrecognized compensation expense related to unvested stock options granted to current and former employees, directors, to be recognized as expense over a weighted-average period of 1.06 years. Presented below is our stock option activity: Six Months Ended June 30, 2016 Number of Options (Employees) Number of Options (Non-Employees) Total Number of Options Weighted-Average Exercise Price Outstanding at January 1, 2016 13,583,862 635,714 14,219,576 $ 3.10 Granted 425,000 — 425,000 $ 2.22 Exercised, Forfeited or Expired (623,284 ) — ( ) $ 3.88 Outstanding at June 30, 2016 13,385,578 635,714 14,021,292 $ 3.04 Options exercisable at June 30, 2016 8,651,113 635,714 9,286,827 $ 3.34 The following table summarizes significant ranges of outstanding stock options under our plans at June 30, 2016: Range of Exercise Prices Total Number of Options Weighted-Average Remaining Contractual Life (years) Weighted-Average Exercise Price Total Number of Options Exercisable Weighted-Average Remaining Contractual Life (years) Weighted-Average Exercise Price $ 1.83 - $2.00 1,224,500 6.45 $ 1.83 1,224,500 6.45 $ 1.83 $ 2.01 – $2.50 8,395,558 8.70 $ 2.32 4,071,021 8.25 $ 2.30 $ 2.51 – $4.00 1,047,693 7.75 $ 2.86 910,194 7.57 $ 2.86 $ 4.01 – $32.55 3,353,541 6.62 $ 5.34 3,081,112 6.54 $ 5.38 14,021,292 7.93 $ 3.04 9,286,827 7.38 $ 3.31 The aggregate intrinsic value of all outstanding options and vested options as of June 30, 2016 was $0.8 million and $0.6 million, respectively, representing options with exercise prices of less than the closing fair market value of our common stock on June 30, 2016 of $2.23 per share. There were 8,359,618 and 7,225,472 warrants outstanding at June 30, 2016 and December 31, 2015, respectively at a weighted-average exercise price of $3.96 and $4.28, respectively. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2016 | |
Fair Value Measurements [Abstract] | |
Fair Value Measurements | 10. Fair Value Measurements Assets and liabilities recorded at fair value on the balance sheets are categorized based upon the level of judgment associated with the inputs used to measure the fair value. Level inputs are as follows: Level 1 – quoted prices in active markets for identical assets or liabilities. Level 2 – other significant observable inputs for the assets or liabilities through corroboration with market data at the measurement date. Level 3 – significant unobservable inputs that reflect management's best estimate of what market participants would use to price the assets or liabilities at the measurement date. The following (In thousands) Level I Level II Level III Total Cash equivalents $ 54,939 $ — $ — $ 54,939 Warrant liability — — — — The following table summarizes fair value measurements by level at December 31, 2015 for assets and liabilities measured at fair value on a recurring basis: (In thousands) Level I Level II Level III Total Cash equivalents $ 20,673 $ — $ — $ 20,673 Short-term investments 35,035 — — 35,035 Warrant liability — — (693 ) (693 ) Liabilities measured at market value on a recurring basis include warrant liability resulting from our August 2011 equity financing. In accordance with ASC 815-40, the warrant liability are marked to market each quarter-end until they are completely settled. The warrants are valued using the Black-Scholes method, using assumptions consistent with our application of ASC 505-50. The $0.7 million decline in fair value of the warrant liability is due to the significant excess of the exercise price over the Company's stock price as of June 30, 2016 and the close proximity to the expiration date of the warrants (see Note 8). We consider carrying amounts of accounts receivable, accounts payable and accrued expenses to approximate fair value due to the short-term nature of these financial instruments. Our non-financial assets are measured at fair value when there is an indicator of impairment and recorded at fair value only when an impairment charge is recognized. Our non-financial assets were not material at or . |
Liquidity and Capital Resources
Liquidity and Capital Resources | 6 Months Ended |
Jun. 30, 2016 | |
Liquidity and Capital Resources [Abstract] | |
Liquidity and Capital Resources | 11 . Liquidity and Capital Resources At June 30, 2016, the Company had cash and cash equivalents of approximately $55.9 million. On July 20, 2016, we completed a public offering of common shares and one-year warrants for net proceeds of approximately $18.3 million. Management believes that our current cash and cash equivalents, along with the net proceeds of the public offering (Se will be sufficient to fund our operations for the foreseeable future. , If we obtain marketing approval and successfully commercializes aldoxorubicin or other product candidates, we anticipate it could take several |
Equity Transactions
Equity Transactions | 6 Months Ended |
Jun. 30, 2016 | |
Equity Transactions [Abstract] | |
Equity Transactions | 12. Equity Transactions On May 25, 2016, we issued 1,561,578 shares of our common stock to settle the liability from the Litigation settlement disclosed in Note 5. In the first quarter of 2016, we issued 100,000 common shares for $0.2 million resulting from the exercise of stock options and warrants to purchase 500,000 common shares at an exercise price of $1.74. As of June 30, 2016, we have reserved approximately 5.9 million of its authorized but unissued shares of common stock for future issuance pursuant to our employee stock option plans issued to employees and consultants. On October 26, 2015, we retired 199,275 shares of our treasury stock at cost ($2.6 million). |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2016 | |
Income Taxes [Abstract] | |
Income Taxes | 13. Income Taxes At December 31, 2015, we had federal and state net operating loss carryforwards as of $281.6 million and $173.7 million, respectively, available to offset against future taxable income, which expire in 2016 through 2034, of which $219.3 million and $173.7 million, respectively, are not subject to limitation under Section 382 of the Internal Revenue Code. |
Commitments and contingencies
Commitments and contingencies | 6 Months Ended |
Jun. 30, 2016 | |
Commitments and contingencies [Abstract] | |
Commitments and contingencies | 14. Commitments and contingencies Commitments We have an agreement with KTB for the Company's exclusive license of patent rights held by KTB for the worldwide development and commercialization of aldoxorubicin. Under the agreement, we must make payments to KTB in the aggregate of $7.5 million upon meeting clinical and regulatory milestones up to and including the product's second final marketing approval. We also has agreed to pay: · commercially reasonable royalties based on a percentage of net sales (as defined in the agreement); · a percentage of non-royalty sub-licensing income (as defined in the agreement); and · milestones of $1 million for each additional final marketing approval that we obtain. In the event that we must pay a third party in order to exercise our right to the intellectual property under the agreement, we will deduct a percentage of those payments from the royalties due KTB, up to an agreed upon cap. Contingencies We applied the disclosure provisions of ASC 460, Guarantees ("ASC 460") to our agreements that contain guarantees or indemnities by us. We provide (i) indemnifications of varying scope and size to certain investors and other parties for certain losses suffered or incurred by the indemnified party in connection with various types of third-party claims; and (ii) indemnifications of varying scope and size to officers and directors against third party claims arising from the services they provide to us. As previously reported in our Annual Report filed with the SEC on March 11, 2016, on June 13, 2014, three purported securities class action lawsuits pending against us and certain of our officers and directors in the United States District Court for the Central District of California were consolidated in the matter of In re CytRx Corporation Securities Litigation, 2:14-CV-01956-GHK (PJWx) (the "Federal Class Action"), and lead plaintiff and lead counsel were appointed. On October 1, 2014, plaintiffs filed a consolidated amended complaint on behalf of all persons who purchased or otherwise acquired its publicly traded securities between November 20, 2013 and March 13, 2014, against us, certain of our officers and directors, a freelance writer, and certain underwriters, including Jefferies LLC, Oppenheimer & Co., LLC, Aegis Corp., and H.C. Wainwright & Co., LLC. The complaint alleged that certain of the defendants violated the Securities Exchange Act of 1934 (the "Exchange Act") by making materially false and misleading statements in press releases, promotional articles, SEC filings and other public statements. The complaint further alleged that certain of the defendants violated the Securities Act of 1933 by making materially misleading statements and omitting material information in its shelf Registration Statement on Form S-3 filed with the SEC on December 6, 2012 and Prospectus Supplement under Rule 424(b)(2) filed with the SEC on January 31, 2014. These allegations arose out of our alleged retention of The DreamTeam Group and MissionIR, external investor and public relations firms unaffiliated with them, as well as our December 9, 2013 grant of stock options to certain board members and officers. The consolidated amended complaint sought damages, including interest, in an unspecified amount, reasonable costs and attorneys' fees, and any equitable, injunctive, or other relief that the court may deem just and proper. On December 5, 2014, we and the individual defendants filed a motion to dismiss the complaint. The Court was scheduled to hear argument on this motion on March 2, 2015. On February 25, 2015, the Court took this motion under submission and took the hearing off calendar. On July 13, 2015, the Court issued an order granting in part and denying in part the motions to dismiss filed by them, the individual defendants and the underwriters. On August 7, 2015, the plaintiffs amended their complaint and on September 8, 2015, the defendants moved to dismiss the amended complaint, in part. On October 23, 2015, the Court took the motion to dismiss under submission and, as a result of the settlement of the case as set forth below, the motion to dismiss was not ruled on by the Court. On April 3, 2014, a purported class action lawsuit was filed against us and certain of our officers and each of our directors, as well as certain underwriters, in the Superior Court of California, County of Los Angeles, captioned Rajasekaran v. CytRx Corporation, et al., BC541426. The complaint purported to be brought on behalf of all shareholders who purchased or otherwise acquired its common stock pursuant or traceable to its public offering that closed on February 5, 2014. The complaint alleged that defendants violated the federal securities laws by making materially false and misleading statements in its filings with the SEC. The complaint sought compensatory damages in an unspecified amount, rescission, and attorney's fees and costs. On October 14, 2014, the Court granted the parties' joint ex parte motion to stay this proceeding pending resolution of motions to dismiss in the related federal action, In re CytRx Corporation Securities Litigation, 2:14-CV-01956-GHK (PJWx). On December 29, 2015, as a result of the parties informing the Court that the settlement of the Federal Class Action also resolved the claims and allegations in the Rajasekaran case, the Superior Court deemed the case closed. On December 10, 2015, we announced that we had reached an agreement to settle the Federal Class Action and filed a Stipulation of Settlement with the Court. A hearing on plaintiffs' motion for preliminary approval of the settlement was held on January 11, 2016. The agreement contained no admission of liability or wrongdoing and included a full release of us and our current and former directors and officers in connection with the allegations. The terms of the agreement provided for a settlement payment to the class of $4,000,000, of which $3,500,000 was paid by its insurance carriers. We also agreed to issue the equivalent number of shares of our common stock to the class of $4,500,000 worth of shares at the prevailing stock price at the time of the Court's final approval of the settlement agreement, but not less than a minimum of 1,200,000 shares and not more than a maximum of 1,800,000 shares. On January 9, 2016, the Court preliminarily approved the settlement, and set a settlement fairness hearing for final approval of the settlement for May 9, 2016. On May 9, 2016, the Court held the hearing for final approval, requested certain information from plaintiff's counsel, and took the matter under submission. On May 18, 2016, the Court entered a judgment and order granting final approval of the class action settlement, resulting in the issuance of 1,561,578 shares of our common stock. On August 14, 2014, a shareholder derivative lawsuit, captioned Pankratz v. Kriegsman, et al., 2:14-cv-06414-PA-JPR, was filed in the United States District Court for the Central District of California purportedly on our behalf against certain of our officers and each of our directors. On August 15, 2014, a virtually identical complaint was filed, captioned Taylor v. Kriegsman, et al., 2:14-cv-06451. Each of the complaints alleges breach of fiduciary duties, unjust enrichment, gross mismanagement, abuse of control, insider selling and misappropriation of information in connection with our alleged retention of DreamTeamGroup and MissionIR, as well as our December 9, 2013 grant of stock options to certain board members and officers. The complaint seeks unspecified damages, corporate governance and internal procedures reforms, restitution, disgorgement of all profits, benefits, and other compensation obtained by the individual defendants, and the costs and disbursements of the action. On October 8, 2014, the Court in Pankratz and Taylor consolidated the cases and appointed lead plaintiffs and co-lead counsel. On October 20, 2014, we and the individual defendants filed motions to dismiss the consolidated Pankratz and Taylor cases or, in the alternative, to stay the cases. On January 9, 2015, the Court stayed the action pending the resolution of a related consolidated Delaware derivative action, In re CytRx Corp. Stockholder Derivative Litigation, C.A. No. 9864 VCL. On February 27, 2015, the Pankratz and Taylor plaintiffs filed a motion to vacate the stay. On June 24, 2015, the Court granted the motion to lift the stay in light of the pending settlement of the Delaware derivative litigation discussed above. The Court further denied the motion to dismiss without prejudice and invited us to move to dismiss the case within 30 days pursuant to the doctrine of forum non conveniens forum non conveniens forum non conveniens, On January 5, 2016, we announced that we had reached an agreement to settle the consolidated stockholder derivative lawsuits, In Re CytRx Corporation Stockholder Derivative Litigation Niedermayer Niedermayer Niedermayer On December 14, 2015, a shareholder derivative complaint, captioned Niedermeyer et al. v. Kriegsman et al. Niedermayer Niedermayer In Re CytRx Corporation Stockholder Derivative Litigation In re CytRx Corp. Stockholder Derivative Litigation, C.A. No. 9864-VCL Niedermayer In Re CytRx Corporation Stockholder Derivative Litigation Niedermayer Niedermayer In Re CytRx Corporation Stockholder Derivative Litigation Niedermayer Niedermayer On July 25, 2016, a class action complaint was filed in the U.S. District Court for the Central District of California, titled Crihfield v. CytRx Corp. et al., Case No. 2:16-cv-05519, claiming that we and certain of our officers violated the Exchange Act by allegedly making materially false and/or misleading statements, and/or failing to disclose material adverse facts to the effect that the clinical hold placed on the Phase 3 trial of aldoxorubicin for STS would prevent sufficient follow-up for patients involved in the study, thus requiring further analysis, which could cause the trial's results and/or FDA approval to be materially adversely affected or delayed. The plaintiff asserts that such wrongful acts and omissions caused significant losses and damages to a class of persons and entities that acquired our securities between November 18, 2014 and July 11, 2016, and seeks an award of compensatory damages, costs and expenses, including counsel and expert fees, and such other and further relief as the Court may deem just and proper. We intend to vigorously defend against the foregoing complaints. We have directors' and officers' liability insurance, which will be utilized in the defense of these matters. The liability insurance may not cover all of the future liabilities we may incur in connection with the foregoing matters. We evaluate developments in legal proceedings and other matters on a quarterly basis. If an unfavorable outcome becomes probable and reasonably estimable, we could incur charges that could have a material adverse impact on our financial condition and results of operations for the period in which the outcome becomes probable and reasonably estimable. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2016 | |
Subsequent Events [Abstract] | |
Subsequent Events | 15. Subsequent Events On July 20, 2016, we completed a public offering, in which we sold and issued 28,571,429 shares of common stock at a price of $0.70 per share and issued one-year warrants to purchase up to 28,571,429 shares of our common stock at an exercise price of $0.70 per share. Net of underwriting discounts, legal, accounting and other offering expenses, we received proceeds of approximately $18.3 million. |
Term Loan (Tables)
Term Loan (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Term Loan [Abstract] | |
Schedule of term loan | The following sets forth information regarding the current and long-term portion of the loan: June 30, 2016 Term Loan Principal - Current $ 2,441,277 Issuance Cost - Current (119,189 ) Loan Discount - Current (605,823 ) Term Loan, Net - Current $ 1,716,265 Term Loan Principal $ 22,558,723 End Fee Payable 1,771,250 Long Term Issuance Cost (385,955 ) Long Term Loan Discount (2,073,806 ) Long Term Loan, Net $ 21,870,212 |
Warrant Liabilities (Tables)
Warrant Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Warrant Liabilities [Abstract] | |
Schedule of weighted-average assumptions | The following reflects the weighted-average assumptions for each of the six-month periods indicated: Six Months Ended June 30, 2016 2015 Risk-free interest rate 0.20 % 0.28 % Expected dividend yield 0 % 0 % Expected lives 0.09 1.09 Expected volatility 59.3 % 62.7 % Warrants classified as liabilities (in shares) 6,371,854 6,371,854 |
Stock Based Compensation (Table
Stock Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Stock Based Compensation [Abstract] | |
Schedule of total stock-based compensation expense from stock options and warrants | The following table sets forth the total stock-based compensation expense resulting from stock options and warrants included in our Condensed Statements of Operations: Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Research and development — employee $ 507,195 $ 392,842 $ 988,006 $ 728,780 General and administrative — employee 2,499,368 1,744,440 3,156,418 2,699,844 Total employee stock-based compensation $ 3,006,563 $ 2,137,282 $ 4,144,424 $ 3,428,624 Research and development — non-employee $ — $ — $ — $ — General and administrative — non-employee 32,506 140,533 220,462 234,084 Total non-employee stock-based compensation $ 32,506 $ 140,533 $ 220,462 $ 234,084 |
Schedule of share-based payment award, fair value of the stock options granted , assumptions | The fair value of the stock options was estimated using the Black-Scholes option-pricing model, based on the following assumptions: Six Months Ended June 30, 2016 Six Months Ended June 30, 2015 Risk-free interest rate 1.47 % 2.21 % Expected volatility 76.3 % 78.2% - 84.4 % Expected lives (years) 5 - 10 6 - 10 Expected dividend yield 0.00 % 0.00 % |
Schedule of share-based compensation, stock options, activity | Presented below is our stock option activity: Six Months Ended June 30, 2016 Number of Options (Employees) Number of Options (Non-Employees) Total Number of Options Weighted-Average Exercise Price Outstanding at January 1, 2016 13,583,862 635,714 14,219,576 $ 3.10 Granted 425,000 — 425,000 $ 2.22 Exercised, Forfeited or Expired (623,284 ) — ( ) $ 3.88 Outstanding at June 30, 2016 13,385,578 635,714 14,021,292 $ 3.04 Options exercisable at June 30, 2016 8,651,113 635,714 9,286,827 $ 3.34 |
Schedule of share-based compensation, summarizes significant ranges of outstanding stock options | The following table summarizes significant ranges of outstanding stock options under our plans at June 30, 2016: Range of Exercise Prices Total Number of Options Weighted-Average Remaining Contractual Life (years) Weighted-Average Exercise Price Total Number of Options Exercisable Weighted-Average Remaining Contractual Life (years) Weighted-Average Exercise Price $ 1.83 - $2.00 1,224,500 6.45 $ 1.83 1,224,500 6.45 $ 1.83 $ 2.01 – $2.50 8,395,558 8.70 $ 2.32 4,071,021 8.25 $ 2.30 $ 2.51 – $4.00 1,047,693 7.75 $ 2.86 910,194 7.57 $ 2.86 $ 4.01 – $32.55 3,353,541 6.62 $ 5.34 3,081,112 6.54 $ 5.38 14,021,292 7.93 $ 3.04 9,286,827 7.38 $ 3.31 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Fair Value Measurements [Abstract] | |
Fair value measurements by level for assets and liabilities measured at fair value on a recurring basis | The following (In thousands) Level I Level II Level III Total Cash equivalents $ 54,939 $ — $ — $ 54,939 Warrant liability — — — — The following table summarizes fair value measurements by level at December 31, 2015 for assets and liabilities measured at fair value on a recurring basis: (In thousands) Level I Level II Level III Total Cash equivalents $ 20,673 $ — $ — $ 20,673 Short-term investments 35,035 — — 35,035 Warrant liability — — (693 ) (693 ) |
Description of Company and Ba25
Description of Company and Basis of Presentation (Details) | 3 Months Ended | 6 Months Ended |
Jun. 30, 2016Patient | Jun. 30, 2016ClinicalSiteCountry | |
Description of Company and Basis of Presentation [Abstract] | ||
Number of patients enrolled | Patient | 433 | |
Number of clinical sites | ClinicalSite | 79 | |
Number of countries | Country | 15 |
Foreign Currency Remeasurement
Foreign Currency Remeasurement (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Foreign Currency Remeasurement [Abstract] | ||||
Gain (loss) on foreign currency translation adjustment | $ 600 | $ 5,000 | $ 5,800 | $ (10,700) |
Short-term Investment (Details)
Short-term Investment (Details) - USD ($) | Jun. 30, 2016 | Dec. 31, 2015 |
Short-term Investment [Abstract] | ||
Short-term investment | $ 0 | $ 35,035,420 |
Non-Cash Litigation Settlemen28
Non-Cash Litigation Settlement Due in Shares of Common Stock (Details) - USD ($) | Jun. 30, 2016 | May 25, 2016 | May 18, 2016 | Jan. 05, 2016 | Dec. 31, 2015 | Dec. 10, 2015 |
Loss Contingencies [Line Items] | ||||||
Litigation settlement due in shares | $ 700,000 | $ 4,500,000 | ||||
Shares to be issued related to litigation (in shares) | 68,371,643 | 66,480,065 | ||||
Common stock issued for litigation settlement (in shares) | 1,561,578 | 1,561,578 | ||||
Minimum [Member] | ||||||
Loss Contingencies [Line Items] | ||||||
Shares to be issued related to litigation (in shares) | 1,200,000 | |||||
Maximum [Member] | ||||||
Loss Contingencies [Line Items] | ||||||
Shares to be issued related to litigation (in shares) | 1,800,000 | |||||
Litigation Settlement due in Shares of Common Stock [Member] | ||||||
Loss Contingencies [Line Items] | ||||||
Litigation settlement due in shares | $ 4,500,000 | |||||
Corporation Stockholder Derivative Litigation [Member] | Minimum [Member] | ||||||
Loss Contingencies [Line Items] | ||||||
Shares to be issued related to litigation (in shares) | 186,666 | |||||
Corporation Stockholder Derivative Litigation [Member] | Maximum [Member] | ||||||
Loss Contingencies [Line Items] | ||||||
Shares to be issued related to litigation (in shares) | 280,000 | |||||
Corporation Stockholder Derivative Litigation [Member] | Litigation Settlement due in Shares of Common Stock [Member] | ||||||
Loss Contingencies [Line Items] | ||||||
Litigation settlement due in shares | $ 700,000 |
Term Loan (Details)
Term Loan (Details) - USD ($) | Feb. 05, 2016 | Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | Mar. 31, 2016 | Dec. 31, 2015 |
Debt Instrument [Line Items] | |||||||
Amount received under initial loan agreement | $ 24,012,078 | $ 0 | |||||
Term Loan, Net - Current | $ 1,716,265 | 1,716,265 | $ 0 | ||||
Long Term Loan, Net | 21,870,212 | 21,870,212 | $ 0 | ||||
Interest expense | $ 741,346 | $ 0 | $ 1,158,148 | 0 | |||
Warrants [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Number of warrants issued (in shares) | 500,000 | 500,000 | 500,000 | ||||
Exercise price of warrant issued (in dollars per share) | $ 1.74 | $ 1.74 | $ 1.74 | ||||
Hercules Technology Growth Capital, Inc. and Hercules Technology III, L.P. [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Maximum borrowing capacity under long-term loan agreement | $ 40,000,000 | ||||||
Amount received under initial loan agreement | 25,000,000 | ||||||
Additional maximum borrowing capacity under long-term loan agreement | $ 15,000,000 | ||||||
Debt instrument, interest rate | 9.50% | ||||||
Debt instrument, minimum cash balance required to be maintained | $ 10,000,000 | ||||||
Debt instrument, maturity date | Feb. 1, 2020 | ||||||
Term Loan Principal - Current | $ 2,441,277 | $ 2,441,277 | |||||
Issuance Cost - Current | (119,189) | (119,189) | |||||
Loan Discount - Current | (605,823) | (605,823) | |||||
Term Loan, Net - Current | 1,716,265 | 1,716,265 | |||||
Term Loan Principal | 22,558,723 | 22,558,723 | |||||
End Fee Payable | 1,771,250 | 1,771,250 | |||||
Loan Term Issuance Cost | (385,955) | (385,955) | |||||
Long Term Loan Discount | (2,073,806) | (2,073,806) | |||||
Long Term Loan, Net | 21,870,212 | 21,870,212 | |||||
Interest expense | 741,346 | $ 0 | 1,158,148 | $ 0 | |||
Hercules Technology Growth Capital, Inc. and Hercules Technology III, L.P. [Member] | Warrants [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Number of warrants issued (in shares) | 634,146 | ||||||
Exercise price of warrant issued (in dollars per share) | $ 2.05 | ||||||
Fair value of warrants classified as equity warrants | $ 633,749 | $ 633,749 | |||||
Hercules Technology Growth Capital, Inc. and Hercules Technology III, L.P. [Member] | Prime Rate [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Debt instrument, basis spread on variable rate | 6.00% |
Basic and Diluted Net Loss Pe30
Basic and Diluted Net Loss Per Common Share (Details) - shares shares in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Basic and Diluted Net Loss Per Common Share [Abstract] | ||||
Antidilutive securities excluded from computation of earnings per share (in shares) | 22.4 | 17.8 | 22.4 | 17.8 |
Warrant Liabilities (Details)
Warrant Liabilities (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Derivative [Line Items] | ||||
Gain on warrant liability | $ 877,729 | $ 2,435,865 | $ 693,457 | $ 564,570 |
Warrants [Member] | ||||
Derivative [Line Items] | ||||
Risk-free interest rate | 0.20% | 0.28% | ||
Expected dividend yield | 0.00% | 0.00% | ||
Expected lives | 1 month 2 days | 1 year 1 month 2 days | ||
Expected volatility | 59.30% | 62.70% | ||
Warrants classified as liabilities (in shares) | 6,371,854 | 6,371,854 | 6,371,854 | 6,371,854 |
Gain on warrant liability | $ 877,729 | $ 2,435,865 | $ 693,457 | $ 564,570 |
Warrant expiration date | Aug. 1, 2016 |
Stock Based Compensation (Detai
Stock Based Compensation (Details) - USD ($) | Jul. 12, 2016 | Jun. 30, 2016 | Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Mar. 31, 2016 |
Weighted-Average Exercise Price Options [Abstract] | ||||||
Share based compensation expense | $ 4,364,886 | $ 3,662,708 | ||||
Employees [Member] | ||||||
Share-based compensation arrangement by share-based payment award, fair value assumptions and methodology [Abstract] | ||||||
Estimated annualized forfeiture rate | 10.00% | 10.00% | ||||
Non-Employees [Member] | ||||||
Share-based compensation arrangement by share-based payment award, fair value assumptions and methodology [Abstract] | ||||||
Estimated annualized forfeiture rate | 0.00% | 0.00% | ||||
Employees and Directors [Member] | ||||||
Share-based compensation arrangement by share-based payment award, fair value assumptions and methodology [Abstract] | ||||||
Unrecognized compensation expense related to unvested stock options, granted | $ 12,300,000 | |||||
Unrecognized compensation cost, recognized as expense over a weighted-average period | 1 year 22 days | |||||
Senior Management [Member] | ||||||
Share-based compensation arrangement by share-based payment award, fair value assumptions and methodology [Abstract] | ||||||
Estimated annualized forfeiture rate | 2.00% | 2.00% | ||||
Directors [Member] | ||||||
Share-based compensation arrangement by share-based payment award, fair value assumptions and methodology [Abstract] | ||||||
Estimated annualized forfeiture rate | 0.00% | 0.00% | ||||
Former Executive [Member] | ||||||
Weighted-Average Exercise Price Options [Abstract] | ||||||
Share based compensation expense | $ 1,900,000 | |||||
Stock Options [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based compensation, shares subject to stock options (in shares) | 14,021,292 | 14,219,576 | 14,021,292 | |||
Share-based compensation arrangement by share-based payment award, fair value assumptions and methodology [Abstract] | ||||||
Contractual term and expected life | 10 years | |||||
Number of Options (Employees and Non-Employees) [Abstract] | ||||||
Outstanding at beginning of period (in shares) | 14,219,576 | |||||
Granted (in shares) | 425,000 | 550,000 | ||||
Exercised, forfeited or expired (in shares) | (623,284) | |||||
Outstanding at end of period (in shares) | 14,021,292 | 14,021,292 | ||||
Options exercisable at end of period (in shares) | 9,286,827 | 9,286,827 | ||||
Weighted-Average Exercise Price Options [Abstract] | ||||||
Outstanding at beginning of period (in dollars per share) | $ 3.10 | |||||
Granted (in dollars per share) | 2.22 | |||||
Exercised, forfeited or expired (in dollars per share) | 3.88 | |||||
Outstanding at end of period (in dollars per share) | $ 3.04 | 3.04 | ||||
Options exercisable at end of period (in dollars per share) | $ 3.34 | $ 3.34 | ||||
Stock Options [Member] | Employees [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based compensation, shares subject to stock options (in shares) | 13,385,578 | 13,583,862 | 13,385,578 | |||
Number of Options (Employees and Non-Employees) [Abstract] | ||||||
Outstanding at beginning of period (in shares) | 13,583,862 | |||||
Granted (in shares) | 425,000 | |||||
Exercised, forfeited or expired (in shares) | (623,284) | |||||
Outstanding at end of period (in shares) | 13,385,578 | 13,385,578 | ||||
Options exercisable at end of period (in shares) | 8,651,113 | 8,651,113 | ||||
Stock Options [Member] | Non-Employees [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based compensation, shares subject to stock options (in shares) | 635,714 | 635,714 | 635,714 | |||
Number of Options (Employees and Non-Employees) [Abstract] | ||||||
Outstanding at beginning of period (in shares) | 635,714 | |||||
Granted (in shares) | 0 | |||||
Exercised, forfeited or expired (in shares) | 0 | |||||
Outstanding at end of period (in shares) | 635,714 | 635,714 | ||||
Options exercisable at end of period (in shares) | 635,714 | 635,714 | ||||
Stock Options and Warrants [Member] | ||||||
Share-based compensation arrangement by share-based payment award, fair value assumptions and methodology [Abstract] | ||||||
Risk-free interest rate | 1.47% | 2.21% | ||||
Expected volatility | 76.30% | |||||
Expected dividend yield | 0.00% | 0.00% | ||||
Stock Options and Warrants [Member] | Minimum [Member] | ||||||
Share-based compensation arrangement by share-based payment award, fair value assumptions and methodology [Abstract] | ||||||
Expected volatility | 78.20% | |||||
Expected lives | 5 years | 6 years | ||||
Stock Options and Warrants [Member] | Maximum [Member] | ||||||
Share-based compensation arrangement by share-based payment award, fair value assumptions and methodology [Abstract] | ||||||
Expected volatility | 84.40% | |||||
Expected lives | 10 years | 10 years | ||||
Warrants [Member] | ||||||
Weighted-Average Exercise Price Options [Abstract] | ||||||
Number of warrants issued (in shares) | 500,000 | 500,000 | ||||
Exercise price of warrants (in dollars per share) | $ 1.74 | $ 1.74 | ||||
2000 Long-Term Incentive Plan [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based compensation, shares subject to stock options (in shares) | 600,000 | 600,000 | 600,000 | |||
Expiration date | Aug. 6, 2010 | |||||
Share-based compensation, shares available for future grant (in shares) | 0 | |||||
Number of Options (Employees and Non-Employees) [Abstract] | ||||||
Outstanding at end of period (in shares) | 600,000 | 600,000 | ||||
2008 Stock Incentive Plan [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based compensation, shares subject to stock options (in shares) | 14,000,000 | 14,000,000 | 14,000,000 | |||
Share-based compensation, shares available for future grant (in shares) | 5,900,000 | |||||
Share-based compensation, increase in shares available for future grant (in shares) | 10,000,000 | |||||
Number of Options (Employees and Non-Employees) [Abstract] | ||||||
Outstanding at end of period (in shares) | 14,000,000 | 14,000,000 |
Stock Based Compensation, Sched
Stock Based Compensation, Schedule of Employee and Non Employee Service Share Based Compensation (Details) - Stock Options and Warrants [Member] - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Employees [Member] | ||||
Total stock-based compensation expense resulting from stock options and warrants [Abstract] | ||||
Allocated employee and non-employee stock-based compensation expense, Total | $ 3,006,563 | $ 2,137,282 | $ 4,144,424 | $ 3,428,624 |
Non-Employees [Member] | ||||
Total stock-based compensation expense resulting from stock options and warrants [Abstract] | ||||
Allocated employee and non-employee stock-based compensation expense, Total | 32,506 | 140,533 | 220,462 | 234,084 |
Research and Development Expense [Member] | Employees [Member] | ||||
Total stock-based compensation expense resulting from stock options and warrants [Abstract] | ||||
Allocated employee and non-employee stock-based compensation expense, Total | 507,195 | 392,842 | 988,006 | 728,780 |
Research and Development Expense [Member] | Non-Employees [Member] | ||||
Total stock-based compensation expense resulting from stock options and warrants [Abstract] | ||||
Allocated employee and non-employee stock-based compensation expense, Total | 0 | 0 | 0 | 0 |
General and Administrative Expense [Member] | Employees [Member] | ||||
Total stock-based compensation expense resulting from stock options and warrants [Abstract] | ||||
Allocated employee and non-employee stock-based compensation expense, Total | 2,499,368 | 1,744,440 | 3,156,418 | 2,699,844 |
General and Administrative Expense [Member] | Non-Employees [Member] | ||||
Total stock-based compensation expense resulting from stock options and warrants [Abstract] | ||||
Allocated employee and non-employee stock-based compensation expense, Total | $ 32,506 | $ 140,533 | $ 220,462 | $ 234,084 |
Stock Based Compensation, by Ex
Stock Based Compensation, by Exercise Price Range (Details) $ / shares in Units, $ in Millions | 6 Months Ended | |
Jun. 30, 2016USD ($)$ / sharesshares | Dec. 31, 2015$ / sharesshares | |
Stock Options [Member] | ||
Share based compensation, shares authorized under significant ranges of outstanding stock option plans in period [Abstract] | ||
Number of Options (in shares) | shares | 14,021,292 | |
Weighted-Average Remaining Contractual Life | 7 years 11 months 5 days | |
Weighted-Average Exercise Price (in dollars per share) | $ 3.04 | |
Number of Options Exercisable (in shares) | shares | 9,286,827 | |
Weighted-Average Remaining Contractual Life | 7 years 4 months 17 days | |
Weighted-Average Exercise Price, Options Exercisable (in dollars per share) | $ 3.31 | |
The aggregate intrinsic value of outstanding options | $ | $ 0.8 | |
Aggregate intrinsic value of options vested | $ | $ 0.6 | |
Closing price of the common stock (in dollars per share) | $ 2.23 | |
Warrants [Member] | ||
Share based compensation, shares authorized under significant ranges of outstanding stock option plans in period [Abstract] | ||
Warrants outstanding (in shares) | shares | 8,359,618 | 7,225,472 |
Weighted-average exercise price of warrants outstanding (in dollars per share) | 3.96 | 4.28 |
Range $1.83 - $2.00 [Member] | Stock Options [Member] | ||
Share based compensation, shares authorized under significant ranges of outstanding stock option plans in period [Abstract] | ||
Range of Exercise Prices, Lower Range (in dollars per share) | $ 1.83 | |
Range of Exercise Prices, Upper Range (in dollars per share) | $ 2 | |
Number of Options (in shares) | shares | 1,224,500 | |
Weighted-Average Remaining Contractual Life | 6 years 5 months 12 days | |
Weighted-Average Exercise Price (in dollars per share) | $ 1.83 | |
Number of Options Exercisable (in shares) | shares | 1,224,500 | |
Weighted-Average Remaining Contractual Life | 6 years 5 months 12 days | |
Weighted-Average Exercise Price, Options Exercisable (in dollars per share) | $ 1.83 | |
Range $2.01 - 2.50 [Member] | Stock Options [Member] | ||
Share based compensation, shares authorized under significant ranges of outstanding stock option plans in period [Abstract] | ||
Range of Exercise Prices, Lower Range (in dollars per share) | 2.01 | |
Range of Exercise Prices, Upper Range (in dollars per share) | $ 2.50 | |
Number of Options (in shares) | shares | 8,395,558 | |
Weighted-Average Remaining Contractual Life | 8 years 8 months 12 days | |
Weighted-Average Exercise Price (in dollars per share) | $ 2.32 | |
Number of Options Exercisable (in shares) | shares | 4,071,021 | |
Weighted-Average Remaining Contractual Life | 8 years 3 months | |
Weighted-Average Exercise Price, Options Exercisable (in dollars per share) | $ 2.30 | |
Range $2.51 - 4.00 [Member] | Stock Options [Member] | ||
Share based compensation, shares authorized under significant ranges of outstanding stock option plans in period [Abstract] | ||
Range of Exercise Prices, Lower Range (in dollars per share) | 2.51 | |
Range of Exercise Prices, Upper Range (in dollars per share) | $ 4 | |
Number of Options (in shares) | shares | 1,047,693 | |
Weighted-Average Remaining Contractual Life | 7 years 9 months | |
Weighted-Average Exercise Price (in dollars per share) | $ 2.86 | |
Number of Options Exercisable (in shares) | shares | 910,194 | |
Weighted-Average Remaining Contractual Life | 7 years 6 months 25 days | |
Weighted-Average Exercise Price, Options Exercisable (in dollars per share) | $ 2.86 | |
Range $4.01 - 32.55 [Member] | Stock Options [Member] | ||
Share based compensation, shares authorized under significant ranges of outstanding stock option plans in period [Abstract] | ||
Range of Exercise Prices, Lower Range (in dollars per share) | 4.01 | |
Range of Exercise Prices, Upper Range (in dollars per share) | $ 32.55 | |
Number of Options (in shares) | shares | 3,353,541 | |
Weighted-Average Remaining Contractual Life | 6 years 7 months 13 days | |
Weighted-Average Exercise Price (in dollars per share) | $ 5.34 | |
Number of Options Exercisable (in shares) | shares | 3,081,112 | |
Weighted-Average Remaining Contractual Life | 6 years 6 months 14 days | |
Weighted-Average Exercise Price, Options Exercisable (in dollars per share) | $ 5.38 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Recurring [Member] - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Fair value measurements by level for assets and liabilities measured at fair value on a recurring basis [Abstract] | ||
Cash equivalents | $ 54,939 | $ 20,673 |
Short-term investments | 35,035 | |
Warrant liability | 0 | (693) |
Level I [Member] | ||
Fair value measurements by level for assets and liabilities measured at fair value on a recurring basis [Abstract] | ||
Cash equivalents | 54,939 | 20,673 |
Short-term investments | 35,035 | |
Warrant liability | 0 | 0 |
Level II [Member] | ||
Fair value measurements by level for assets and liabilities measured at fair value on a recurring basis [Abstract] | ||
Cash equivalents | 0 | 0 |
Short-term investments | 0 | |
Warrant liability | 0 | 0 |
Level III [Member] | ||
Fair value measurements by level for assets and liabilities measured at fair value on a recurring basis [Abstract] | ||
Cash equivalents | 0 | 0 |
Short-term investments | 0 | |
Warrant liability | $ 0 | $ (693) |
Liquidity and Capital Resourc36
Liquidity and Capital Resources (Details) - USD ($) | Jul. 20, 2016 | Jun. 30, 2016 | Dec. 31, 2015 | Jun. 30, 2015 | Dec. 31, 2014 |
Estimated Projected Expenditure [Line Items] | |||||
Cash and cash equivalents | $ 55,913,199 | $ 22,261,372 | $ 38,833,736 | $ 32,218,905 | |
Currently projected expenditures for clinical programs | 42,700,000 | ||||
Subsequent Event [Member] | |||||
Estimated Projected Expenditure [Line Items] | |||||
Proceeds from public offering of common shares and warrants | $ 18,300,000 | ||||
Aldoxorubicin [Member] | |||||
Estimated Projected Expenditure [Line Items] | |||||
Currently projected expenditures for clinical programs | 21,600,000 | ||||
Other Programs [Member] | |||||
Estimated Projected Expenditure [Line Items] | |||||
Currently projected expenditures for clinical programs | 5,300,000 | ||||
General Operation [Member] | |||||
Estimated Projected Expenditure [Line Items] | |||||
Currently projected expenditures for clinical programs | 3,200,000 | ||||
Other General and Administrative Expenses [Member] | |||||
Estimated Projected Expenditure [Line Items] | |||||
Currently projected expenditures for clinical programs | 8,900,000 | ||||
Interest and Term Loan Payment [Member] | |||||
Estimated Projected Expenditure [Line Items] | |||||
Currently projected expenditures for clinical programs | $ 3,700,000 |
Equity Transactions (Details)
Equity Transactions (Details) - USD ($) $ / shares in Units, $ in Millions | Oct. 26, 2015 | Mar. 31, 2016 | Jun. 30, 2016 | May 25, 2016 | May 18, 2016 |
Class of Stock [Line Items] | |||||
Common stock issued for litigation settlement (in shares) | 1,561,578 | 1,561,578 | |||
Common shares issued from exercise of stock options (in shares) | 100,000 | ||||
Authorized but unissued shares of common stock (in shares) | 5,900,000 | ||||
Number of treasury stock retired (in shares) | 199,275 | ||||
Number of treasury stock retired, value | $ (2.6) | ||||
Net proceeds from the issuance of common stock | $ 0.2 | ||||
Warrants [Member] | |||||
Class of Stock [Line Items] | |||||
Number of warrants issued (in shares) | 500,000 | 500,000 | |||
Exercise price of warrants (in dollars per share) | $ 1.74 | $ 1.74 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Millions | 6 Months Ended | |
Jun. 30, 2016 | Dec. 31, 2015 | |
Earliest Tax Year [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Expiration date | Dec. 31, 2016 | |
Latest Tax Year [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Expiration date | Dec. 31, 2034 | |
Federal [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | $ 281.6 | |
Federal [Member] | Unrestricted [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | 219.3 | |
State [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | 173.7 | |
State [Member] | Unrestricted [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | $ 173.7 |
Commitments and contingencies (
Commitments and contingencies (Details) | Dec. 10, 2015USD ($)shares | Jun. 30, 2016USD ($)dshares | Jun. 30, 2015USD ($) | May 25, 2016shares | May 18, 2016shares | Feb. 26, 2016Motion | Jan. 05, 2016USD ($)shares | Dec. 31, 2015USD ($)shares | Jun. 13, 2014Lawsuit |
Loss Contingencies [Line Items] | |||||||||
Amount of milestone payment payable | $ 7,500,000 | ||||||||
Potential future milestone payments on each additional final marketing approval | $ 1,000,000 | ||||||||
Number of purported securities class action lawsuits pending | Lawsuit | 3 | ||||||||
Number of day's court afforded the plaintiffs to amend their complaint | d | 30 | ||||||||
Litigation settlement payment | $ 4,000,000 | $ 700,000 | $ 0 | ||||||
Litigation settlement due in shares | $ 700,000 | $ 4,500,000 | |||||||
Common stock issued (in shares) | shares | 68,371,643 | 66,480,065 | |||||||
Common stock issued for litigation settlement (in shares) | shares | 1,561,578 | 1,561,578 | |||||||
Number of motions filed by the company | Motion | 2 | ||||||||
Minimum [Member] | |||||||||
Loss Contingencies [Line Items] | |||||||||
Legal fees to be reimbursed by insurance carrier | $ 3,500,000 | ||||||||
Common stock issued (in shares) | shares | 1,200,000 | ||||||||
Maximum [Member] | |||||||||
Loss Contingencies [Line Items] | |||||||||
Common stock issued (in shares) | shares | 1,800,000 | ||||||||
Litigation settlement due in shares of common [Member] | |||||||||
Loss Contingencies [Line Items] | |||||||||
Litigation settlement due in shares | $ 4,500,000 | ||||||||
Corporation Stockholder Derivative Litigation [Member] | Minimum [Member] | |||||||||
Loss Contingencies [Line Items] | |||||||||
Common stock issued (in shares) | shares | 186,666 | ||||||||
Corporation Stockholder Derivative Litigation [Member] | Maximum [Member] | |||||||||
Loss Contingencies [Line Items] | |||||||||
Common stock issued (in shares) | shares | 280,000 | ||||||||
Corporation Stockholder Derivative Litigation [Member] | Litigation settlement due in shares of common [Member] | |||||||||
Loss Contingencies [Line Items] | |||||||||
Litigation settlement due in shares | $ 700,000 |
Subsequent Events (Details)
Subsequent Events (Details) - Subsequent Event [Member] $ / shares in Units, $ in Millions | Jul. 20, 2016USD ($)$ / sharesshares |
Subsequent Event [Line Items] | |
New issuance of shares (in shares) | shares | 28,571,429 |
Share price (in dollars per share) | $ / shares | $ 0.70 |
Warrants exercised period | 1 year |
Common stock warrants (in shares) | shares | 28,571,429 |
Exercise price of warrants (in dollars per share) | $ / shares | $ 0.70 |
Offering of common shares and warrants for net proceeds | $ | $ 18.3 |