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Jun. 30, 2015
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Aug. 07, 2015
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Document Information [Line Items] | ||
Entity Registrant Name | Lion Biotechnologies, Inc. | |
Entity Central Index Key | 0001425205 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 47,191,900 | |
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2015 | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2015 |
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Condensed Balance Sheets (Parenthetical) (USD $)
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Jun. 30, 2015
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Dec. 31, 2014
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Condensed Balance Sheets [Abstract] | ||
Property and equipment, accumulated depreciation | $ 529,866 | $ 104,223 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 50,000,000 | 50,000,000 |
Preferred stock, shares issued | 3,694 | 5,694 |
Preferred stock, shares outstanding | 3,694 | 5,694 |
Common stock, par value (in dollars per share) | $ 0.000041666 | $ 0.000041666 |
Common stock, shares authorized | 150,000,000 | 150,000,000 |
Common stock, shares issued | 47,140,195 | 33,750,188 |
Common stock, shares outstanding | 47,140,195 | 33,750,188 |
Common stock to be issued shares | 303,125 | 303,125 |
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Condensed Statements of Operations (USD $)
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Condensed Statements of Operations [Abstract] | ||||||||||||
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Operating expenses | 2,384,537 | [1] | 1,616,175 | [1] | 4,897,154 | [1] | 3,154,233 | [1] | ||||
Research and development | 4,055,688 | [2] | 493,994 | [2] | 6,841,131 | [2] | 1,215,450 | [2] | ||||
Total costs and expenses | 6,440,225 | 2,110,169 | 11,738,285 | 4,369,683 | ||||||||
Loss from operations | (6,440,225) | (2,110,169) | (11,738,285) | (4,369,683) | ||||||||
Interest income | 72,735 | 72,735 | ||||||||||
Net Loss | $ (6,367,490) | $ (2,110,169) | $ (11,665,550) | $ (4,369,683) | ||||||||
Net Loss Per Share, Basic and Diluted | $ (0.14) | $ (0.09) | $ (0.28) | $ (0.19) | ||||||||
Weighted-Average Common Shares Outstanding, Basic and Diluted | 45,082,176 | 24,137,782 | 41,413,501 | 22,502,761 | ||||||||
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Condensed Statements of Operations (Parenthetical) (USD $)
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Operating Expense [Member]
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Share-based Compensation | $ 1,114,224 | $ 460,884 | $ 1,805,272 | $ 1,229,767 |
Research and Development Expense [Member]
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Share-based Compensation | $ 809,486 | $ 418,794 | $ 1,583,895 | $ 551,561 |
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Condensed Statements of Comprehensive Loss (USD $)
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Statement of Comprehensive Income [Abstract] | ||||
Net Loss | $ (6,367,490) | $ (2,110,169) | $ (11,665,550) | $ (4,369,683) |
Other comprehensive income: | ||||
Unrealized gain on short-term investments | 21,704 | 21,704 | ||
Comprehensive Loss | $ (6,345,786) | $ (2,110,169) | $ (11,643,846) | $ (4,369,683) |
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GENERAL ORGANIZATION AND BUSINESS
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6 Months Ended |
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Jun. 30, 2015
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GENERAL ORGANIZATION AND BUSINESS [Abstract] | |
GENERAL ORGANIZATION AND BUSINESS | NOTE 1. GENERAL ORGANIZATION AND BUSINESS
Lion Biotechnologies, Inc. (the Company, we, us or our) is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient's own immune system to eradicate cancer cells. Our lead program is an adoptive cell therapy utilizing tumor-infiltrating lymphocytes (TIL), which are T cells derived from patients' tumors, for the treatment of metastatic melanoma. The TIL are then activated and expanded ex vivo and then infused back into the patient to fight their tumor cells. The Company was originally incorporated under the laws of the state of Nevada on September 17, 2007. Until March 2010, we were an inactive company known as Freight Management Corp. On March 15, 2010, we changed our name to Genesis Biopharma, Inc., and in 2011 we commenced our current business.
Basis of Presentation of Unaudited Condensed Financial Information
The unaudited condensed financial statements of the Company for the six month ended June 30, 2015 and 2014 have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information and pursuant to the requirements for reporting on Form 10-Q and Regulation S-K. Accordingly, they do not include all the information and footnotes required by accounting principles generally accepted in the United States of America for complete financial statements. However, such information reflects all adjustments (consisting solely of normal recurring adjustments), which are, in the opinion of management, necessary for the fair presentation of the financial position and the results of operations. Results shown for interim periods are not necessarily indicative of the results to be obtained for a full fiscal year. The balance sheet information as of December 31, 2014 was derived from the audited financial statements included in the Company's financial statements as of and for the year ended December 31, 2014 included in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission (the SEC) on March 16, 2015. These financial statements should be read in conjunction with that report.
Liquidity
We are currently engaged in the development of therapeutics to fight cancer, we do not have any commercial products and have not yet generated any revenues from our biopharmaceutical business. We currently do not anticipate that we will generate any revenues during 2015 from the sale or licensing of any products. In addition, we have not generated any revenues from our prior business plans.
We have not had any revenues and are still in the development stage. As shown in the accompanying condensed financial statements, we have incurred a net loss of $11,665,000 for the six months ended June 30, 2015 and used $7,959,000 of cash in our operating activities during the six months ended June 30, 2015. As of June 30, 2015, we had $112,336,000 of cash, money market funds, and short term investments on hand, stockholders' equity of $112,873,000 and had working capital of $110,848,000.
During 2015, we expect to further ramp up our operations, which will increase the amount of cash we will use in our operations. Our budget for 2015 includes increased spending on research and development activities, higher payroll expenses as we increase our professional staff, the costs associated with operating our new Tampa, Florida, research facility, as well as ongoing payments under the Cooperative Research and Development Agreement (CRADA) we have entered into with the National Cancer Institute (NCI). Based on the funds we had available on June 30, 2015, we believe that we have sufficient capital to fund our anticipated operating expenses for at least 24 months.
On March 3, 2015, the Company sold 9,200,000 shares of its common stock in an underwritten public offering at $8.00 per share for net proceeds of $68.3 million, after deducting expenses of the offering. On December 22, 2014, the Company sold 6,000,000 shares of its common stock in an underwritten public offering at $5.75 per share for net proceeds of $32.2 million after deducting expenses of the offering. On November 5, 2013, we completed a $23.3 million private placement of our securities to various institutional and individual accredited investors. Despite the amount of funds that we have raised, the estimated cost of completing the development of our TIL-based therapy, and of obtaining all required regulatory approvals to market those product candidates, may be substantially greater than the amount of funds we have available. Therefore, while we believe that our existing cash balances will be sufficient to fund our currently planned level of operations for at least 24 months, we will have to obtain additional funds in the future to complete our development plans. We intend to seek this additional funding through various financing sources, including possible sales of our securities, and in the longer term through strategic alliances with other pharmaceutical or biopharmaceutical companies. |
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SUMMARY OF SIGNIFICANT ACCOUNTING PRACTICES
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SUMMARY OF SIGNIFICANT ACCOUNTING PRACTICES | NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING PRACTICES
Cash and Cash Equivalents
The Company considers all highly liquid investments with an original maturity of 90 days or less when purchased to be cash equivalents. The carrying amounts reported in the Balance Sheets for cash and cash equivalents are valued at cost, which approximates their fair value.
Short-term Investments
The Company's short-term investments represent available for sale securities and are recorded at fair value and unrealized gains and losses are recorded within accumulated other comprehensive income (loss). The estimated fair value of the available for sale securities is determined based on quoted market prices or rates for similar instruments. In addition, the cost of debt securities in this category is adjusted for amortization of premium and accretion of discount to maturity. The Company evaluates securities with unrealized losses to determine whether such losses, if any, are other than temporary.
Net Income (Loss) Per Share
Basic net income (loss) per share is computed by dividing net income (loss) by the weighted average number of common shares outstanding for the period, excluding unvested shares of restricted common stock. Shares of restricted stock subject to vesting are included in basic weighted average common shares outstanding from the time they vest. Diluted earnings per share is computed by dividing the net income applicable to common stock holders by the weighted average number of common shares outstanding plus the number of additional common shares that would have been outstanding if all dilutive potential common shares had been issued, using the treasury stock method. Potential common shares are excluded from the computation when their effect is antidilutive. When calculating diluted net income per share, shares of restricted stock subject to vesting are included in diluted weighted average common shares outstanding as of their grant date.
At June 30, 2015 and 2014, basic and diluted net loss per share are the same, as the effect of potentially dilutive securities was antidilutive. At June 30, 2015, potentially dilutive securities include options to acquire 2,238,877 shares of common stock, warrants to acquire 7,894,419 shares of common stock, preferred stock that can be converted into 1,847,000 shares of common stock, and 591,500 shares of non-vested restricted stock. At June 30, 2014, potentially dilutive securities include options to acquire 868,750 shares of common stock, warrants to acquire 11,427,764 shares of common stock, and preferred stock that can be converted into 2,847,000 shares of common stock.
Fair Value Measurements
Under FASB ASC 820, Fair Value Measurements and Disclosures, fair value is defined as the price at which an asset could be exchanged or a liability transferred in a transaction between knowledgeable, willing parties in the principal or most advantageous market for the asset or liability. Where available, fair value is based on observable market prices or parameters or derived from such prices or parameters. Where observable prices or parameters are not available, valuation models are applied.
Assets and liabilities recorded at fair value in our financial statements are categorized based upon the level of judgment associated with the inputs used to measure their fair value. Hierarchical levels directly related to the amount of subjectivity associated with the inputs to fair valuation of these assets and liabilities, are as follows:
Level 1Inputs are unadjusted, quoted prices in active markets for identical assets at the reporting date. Active markets are those in which transactions for the asset or liability occur in sufficient frequency and volume to provide pricing information on an ongoing basis.
The fair valued assets we hold that are generally included under this Level 1 are money market securities where fair value is based on publicly quoted prices.
Level 2Are inputs, other than quoted prices included in Level 1, that are either directly or indirectly observable for the asset or liability through correlation with market data at the reporting date and for the duration of the instrument's anticipated life.
The fair valued assets we hold that are generally assessed under Level 2 corporate bonds and commercial paper. We utilize third party pricing services in developing fair value measurements where fair value is based on valuation methodologies such as models using observable market inputs, including benchmark yields, reported trades, broker/dealer quotes, bids, offers and other reference data. We use quotes from external pricing service providers and other on-line quotation systems to verify the fair value of investments provided by our third party pricing service providers. We review independent auditor's reports from our third party pricing service providers particularly regarding the controls over pricing and valuation of financial instruments and ensure that our internal controls address certain control deficiencies, if any, and complementary user entity controls are in place.
Level 3Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities and which reflect management's best estimate of what market participants would use in pricing the asset or liability at the reporting date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model.
We do not have fair valued assets classified under Level 3.
Fair Value on a Recurring Basis
Financial assets measured at fair value on a recurring basis are categorized in the tables below based upon the lowest level of significant input to the valuations:
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 the reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates. Significant estimates include accounting for potential liabilities and the assumptions made in valuing stock instruments issued for services.
Stock-Based Compensation
The Company periodically grants stock options and warrants to employees and non-employees in non-capital raising transactions as compensation for services rendered. The Company accounts for stock option grants to employees based on the authoritative guidance provided by the Financial Accounting Standards Board where the value of the award is measured on the date of grant and recognized over the vesting period. The Company accounts for stock option grants to non-employees in accordance with the authoritative guidance of the Financial Accounting Standards Board where the value of the stock compensation is determined based upon the measurement date at either a) the date at which a performance commitment is reached, or b) at the date at which the necessary performance to earn the equity instruments is complete. Non-employee stock-based compensation charges generally are amortized over the vesting period on a straight-line basis. In certain circumstances where there are no future performance requirements by the non-employee, option grants are immediately vested and the total stock-based compensation charge is recorded in the period of the measurement date.
The fair value of the Company's common stock option grants is estimated using a Black-Scholes option pricing model, which uses certain assumptions related to risk-free interest rates, expected volatility, expected life of the common stock options, and future dividends. Compensation expense is recorded based upon the value derived from the Black-Scholes option pricing model, and based on actual experience. The assumptions used in the Black-Scholes option pricing model could materially affect compensation expense recorded in future periods.
Research and Development
Research and development costs consist primarily of fees paid to consultants and outside service providers, patent fees and costs, and other expenses relating to the acquisition, design, development and testing of the Company's treatments and product candidates. Research and development costs are expensed as incurred over the life of the underlying contracts on the straight-line basis, unless the achievement of milestones, the completion of contracted work, or other information indicates that a different expensing schedule is more appropriate. The Company reviews the status of its research and development contracts on a quarterly basis.
Concentrations
Financial instruments, which potentially subject the Company to concentrations of credit risk, consist principally of cash and short-term investments.
The Company maintains cash balances at more than one bank. As of June 30, 2015, the Company's cash balances were in excess of insured limits maintained at these banks. Management believes that the financial institutions that hold the Company's cash are financially sound and, accordingly, minimal credit risk exists.
At June 30, 2015, the Company's short-term investments were invested in short-term fixed income debt securities of domestic and foreign high credit issuers and in money market funds. The Company's investment policy limits investments to certain types of instruments such as certificates of deposit, money market instruments, obligations issued by the U.S. government and U.S. government agencies as well as corporate debt securities, and places restrictions on maturities and concentration by type and issuer. At June 30, 2015, approximately 53% of the Company's short-term investments were invested in notes of five companies, approximately 27% were invested in notes of various other domestic issuers, and approximately 20% were invested in notes of a foreign issuer. The average maturity of these notes was 124 days (See Note 6).
Comprehensive Income (Loss)
Components of comprehensive income or loss, including net income or loss, are reported in the financial statements in the period in which they are recognized. Comprehensive income or loss is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. Net income (loss) and other comprehensive income (loss) are reported net of any related tax effect to arrive at comprehensive income (loss). For the three and six months ended June 30, 2015, the Company recorded comprehensive income of $21,704 for unrealized gains on short term investments. The Company did not have any items of comprehensive income (loss) for the three months and six months ended June 30, 2014.
Recent Accounting Pronouncements
In May 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2014-09, Revenue from Contracts with Customers. ASU 2014-09 is a comprehensive revenue recognition standard that will supersede nearly all existing revenue recognition guidance under current U.S. GAAP and replace it with a principle based approach for determining revenue recognition. ASU 2014-09 will require that companies recognize revenue based on the value of transferred goods or services as they occur in the contract. The ASU also will require additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. ASU 2014-09 is effective for interim and annual periods beginning after December 15, 2017. Early adoption is permitted in annual reporting periods beginning after December 15, 2016, and the interim periods within that year, and either full retrospective adoption or modified retrospective adoption is permitted. The Company is in the process of evaluating the impact of ASU 2014-09 on the Company's financial statements and disclosures.
In June 2014, the FASB issued Accounting Standards Update No. 2014-12, Compensation Stock Compensation (Topic 718). The pronouncement was issued to clarify the accounting for share-based payments when the terms of an award provide that a performance target could be achieved after the requisite service period. The pronouncement is effective for reporting periods beginning after December 15, 2015. The adoption of ASU 2014-12 is not expected to have a significant impact on the Company's consolidated financial position or results of operations.
In November 2014, the FASB issued Accounting Standards Update No. 2014-16, Determining Whether the Host Contract in a Hybrid Financial Instrument Issued in the Form of a Share Is More Akin to Debt or to Equity. The amendments in ASU 2014-6 do not change the current criteria in U.S. GAAP for determining when separation of certain embedded derivative features in a hybrid financial instrument is required. The amendments clarify that an entity should consider all relevant terms and features, including the embedded derivative feature being evaluated for bifurcation, in evaluating the nature of the host contract. ASU 2014-6 applies to all entities that are issuers of, or investors in, hybrid financial instruments that are issued in the form of a share and is effective for public business entities for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2015. Early adoption is permitted. The Company is currently evaluating the impact the adoption of ASU 2014-16 on the Company's financial statements and disclosures.
Other recent accounting pronouncements issued by the FASB, including its Emerging Issues Task Force, the American Institute of Certified Public Accountants, and the Securities and Exchange Commission did not or are not believed by management to have a material impact on the Company's present or future consolidated financial statements. Reclassifications
In presenting the Company's statement of operations for the three and six month periods ended June 30, 2014, the Company has reclassified $551,561 and $132,767, respectively, of stock-based compensation that was previously reflected as operating expenses to research and development expenses. The reclassification relates to stock-based compensation to individuals working in the Company's research and development activities, and had no impact on total costs and expenses or net loss. |
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STOCKHOLDERS' EQUITY
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STOCKHOLDERS' EQUITY | NOTE 3. STOCKHOLDERS' EQUITY
Public offering
On March 3, 2015, the Company completed an underwritten public offering of 9,200,000 shares of its common stock at a price of $8.00 per share of common stock. The net proceeds to the Company from the offering were $68.3 million, after deducting underwriting discounts and commissions and offering expenses. The offering was made pursuant to the Company's existing shelf registration statement on Form S-3, including a base prospectus, which was filed with the SEC on November 20, 2014 and declared effective on December 10, 2014, a preliminary prospectus supplement thereunder, and a registration statement on Form S-3 filed with the SEC on February 26, 2015.
On May 6, 2015, certain stockholders of the Company, including certain members of Board of Directors of the Company and their affiliates, sold 4,750,000 shares of the Company's common stock in an underwritten secondary offering at a price of $10.00 per share. The Company did not sell any shares in the offering and will not receive any of the proceeds from the offering.
Issuance of common stock upon conversion of preferred stock
During the six month ended June 30, 2015, the Company issued 1,000,000 shares of common stock upon the conversion of 2,000 shares of Series A Convertible Preferred Stock. The number of conversion shares issued was determined on a formula basis of 500 common shares for each Series A Convertible Preferred Stock held.
Common stock with vesting terms
During 2014, the Company granted 782,500 shares of its restricted common stock to nine of its employees in accordance with the terms of their employment agreements. The 782,500 shares vest over a period of three years. As these shares were granted to employees, the Company calculated the aggregate fair value of the 782,500 shares based on the trading prices of the Company's stock at their grant dates and determined it to be $5,080,090, of which $1,256,985 was expensed in 2014. The allocable portion of the fair value of the stock that vested during the six months ended June 30, 2015 amounted to $1,087,870 and was recognized as expense in the accompanying statements of operations. As of June 30, 2015, the amount of unvested compensation related to all issuances of restricted common stock was $2,948,985, which will be recorded as expense in future periods as the shares vest.
When calculating basic net income (loss) per share, these shares are included in basic weighted average common shares outstanding from the time they vest. When calculating diluted net income (loss) per share, these shares are included in diluted weighted average common shares outstanding from the time they are granted, unless they are antidilutive. Shares of restricted stock granted above are subject to forfeiture to the Company or other restrictions that will lapse in accordance with a vesting schedule determined by our Board.
The following table summarizes restricted common stock activity:
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STOCK OPTIONS AND WARRANTS
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STOCK OPTIONS AND WARRANTS [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
STOCK OPTIONS AND WARRANTS | NOTE 4. STOCK OPTIONS AND WARRANTS
Stock Options
A summary of the status of stock options at June 30, 2015, and the changes during the six months then ended, is presented in the following table:
During the six months ended June 30, 2015, the Company granted options to purchase 452,250 shares of common stock to new employees and directors of the Company. The stock options generally vest between one and three years. The fair value of these options was determined to be $4,701,113 using the Black-Scholes option pricing model based on the following assumptions: (i) volatility rate of 218%, (ii) discount rate of 1.57 %, (iii) zero expected dividend yield, and (iv) expected life of 6 years.
During the six months ended June 30, 2015 and 2014, the Company recorded compensation costs of $2,301,297 and $1,340,601, respectively, relating to the vesting of stock options. As of June 30, 2015, the aggregate value of unvested options was $11,196,570, which will continue to be amortized as compensation cost as the options vest over terms ranging from six months to three years, as applicable.
On March 29, 2010, the Company's Board of Directors adopted the Genesis Biopharma, Inc. 2010 Equity Compensation Plan (the "2010 Plan") pursuant to which the Board reserved an aggregate of 35,000 shares of common stock for future grants of stock options, rights to acquire restricted stock, rights to acquire unrestricted stock, and stock appreciation rights. Options for the issuance of all 35,000 shares have been granted, and no shares are available for additional grants under the 2010 Plan.
On October 14, 2011, the Company's Board of Directors approved a 2011 Equity Incentive Plan (the 2011 Plan). The Company's stockholders did not approve the 2011 Plan within a required one-year period, and accordingly, the Company cannot grant qualified incentive stock options under the 2011 Plan. As of December 31, 2014, no shares were available for future grant under the 2011 Plan.
On September 19, 2014, The Company's Board of Directors adopted the Lion Biotechnologies, Inc. 2014 Equity Incentive Plan (the 2014 Plan). The 2014 Plan was approved by our stockholders at the annual meeting of stockholders held in November 2014. The 2014 Plan initially authorized the issuance up to an aggregate of 2,350,000 shares of common stock. On April 10, 2015 the Board amended the 2014 Plan, subject to stockholder approval, to increase the total number of shares that can be issued under the 2014 Plan by 1,650,000 from 2,350,000 shares to 4,000,000 shares. The increase in shares available for issuance under the 2014 Plan was approved by stockholders on June 12, 2015.
Warrants
A summary of the status of stock warrants at June 30, 2015, and the changes during the six month then ended, is presented in the following table:
During the six months ended June 30, 2015, the Company received $7,975,150 in cash from the exercise of 3,190,007 warrants for the purchase of 3,190,007 shares of its common stock. |
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LICENSE AND COMMITMENTS
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LICENSE AND COMMITMENTS [Abstract] | |
LICENSE AND COMMITMENTS | NOTE 5. LICENSE AND COMMITMENTS
National Institutes of Health and the National Cancer Institute
Effective August 5, 2011, the Company signed a Cooperative Research and Development Agreement (CRADA) with the National Institutes of Health and the National Cancer Institute (NCI). Under the terms of the five-year cooperative research and development agreement, the Company will work with Dr. Steven A. Rosenberg, M.D., Ph.D., chief of NCI's Surgery Branch, to develop adoptive cell immunotherapies that are designed to destroy metastatic melanoma cells using a patient's tumor infiltrating lymphocytes.
The Company initially agreed to pay the NCI $1,000,000 per year ($250,000 per quarter) under the CRADA. On January 22, 2015, the Company executed an amendment (the Amendment) to the CRADA to include four new indications. As amended, in addition to metastatic melanoma, the CRADA now also includes the development of TIL therapy for the treatment of patients with bladder, lung, triple-negative breast, and HPV-associated cancers. Under the Amendment, the NCI also has agreed to provide the Company with samples of all tumors covered by the Amendment for performing studies related to improving TIL selection and/or TIL scale-out production and process development. As amended, the annual payments the Company is required to make to the NCI have increased from $1 million to $2 million, to be paid in quarterly installments of $500,000. As of June 30, 2015, the Company paid the first quarterly installment of $500,000, the second installment of $500,000 is included in accounts payable. Although the CRADA has a five year term, either party to the CRADA has the right to terminate the CRADA upon 60 days' notice to the other party.
During the six months ended June 30, 2015 and 2014, the Company recognized $1,041,667 and $500,000, respectively, of CRADA expenses, which were recorded as part of research and development expenses in the statement of operations. As of December 31, 2014, $250,000 of CRADA expenses were included in the accrued expenses on the accompanying condensed balance sheet.
National Institutes of Health
Effective October 5, 2011, the Company entered into a Patent License Agreement (the License Agreement) with the National Institutes of Health, an agency of the United States Public Health Service within the Department of Health and Human Services (NIH). Pursuant to the License Agreement, NIH granted to the Company a non-exclusive worldwide right and license to develop and manufacture certain proprietary autologous tumor infiltrating lymphocyte adoptive cell therapy products for the treatment of metastatic melanoma, ovarian cancer, breast cancer, and colorectal cancer. The License Agreement requires the Company to pay royalties based on a percentage of net sales (which percentage is in the mid-single digits and subject to certain annual minimum royalty payments), a percentage of revenues from sublicensing arrangements, and lump sum benchmark royalty payments on the achievement of certain clinical and regulatory milestones for each of the various indications and other direct cost incurred by NIH pursuant to the agreement.
On February 9, 2015, the Company entered into an amendment to the License Agreement with the NIH pursuant to which the Company's non-exclusive license to melanoma was converted into an exclusive license. In consideration for the exclusive rights granted under the amendment to the License Agreement, the Company agreed to pay the NIH a non-refundable upfront licensing fee of $350,000, which was recognized as research and development expense during the six month ended June 30, 2015. The Company also agreed to pay customary royalties based on a percentage of net sales (which percentage is in the mid-single digits), a percentage of revenues from sublicensing arrangements, and lump sum benchmark payments upon the successful completion of the Company's first Phase 2 clinical study, the successful completion of the Company's first Phase 3 clinical study, the receipt of the first FDA approval or foreign equivalent for a licensed product or process resulting from the licensed technologies, the first commercial sale of a licensed product or process in the United States, and the first commercial sale of a licensed product or process in any foreign country.
During the six months ended June 30, 2015, there were no net sales subject to certain annual minimum royalty payments or sales that would require us to pay a percentage of revenues from sublicensing arrangements. In addition there were no benchmarks or milestones achieved that would require payment under the lump sum benchmark royalty payments on the achievement of certain clinical and regulatory milestones for each of the various indications.
Exclusive License Agreement
On July 21, 2014, the Company entered into an Exclusive License Agreement (the Moffitt License Agreement), effective as of June 28, 2014, with the H. Lee Moffitt Cancer Center and Research Institute, Inc. (Moffitt) under which the Company received an exclusive, world-wide license to Moffitt's rights in and to two patent-pending technologies related to methods for improving tumor-infiltrating lymphocytes for adoptive cell therapy. Unless earlier terminated, the term of the license extends until the earlier of the expiration of the last patent related to the licensed technology or 20 years after the effective date of the license agreement.
Pursuant to the Moffitt License Agreement, the Company paid an upfront licensing fee of $25,000, which was recognized as research and development expense during 2014. A patent issuance fee will also be payable under the Moffitt License Agreement, upon the issuance of the first U.S. patent covering the subject technology. In addition, the Company agreed to pay milestone license fees upon completion of specified milestones, customary royalties based on a specified percentage of net sales (which percentage is in the low single digits) and sublicensing payments, as applicable, and annual minimum royalties beginning with the first sale of products based on the licensed technologies, which minimum royalties will be credited against the percentage royalty payments otherwise payable in that year. The Company will also be responsible for all costs associated with the preparation, filing, maintenance and prosecution of the patent applications and patents covered by the Moffitt License Agreement related to the treatment of any cancers in the United States, Europe and Japan and in other countries selected that the Company and Moffitt agreed to.
During the six months ended June 30, 2015, there were no net sales subject to certain annual minimum royalty payments or sales that would require us to pay a percentage of revenues from sublicensing arrangements
Exclusive Patent License Agreement
On February 10, 2015, the Company entered into an exclusive Patent License Agreement with the NIH under which the Company received an exclusive, world-wide license to the NIH's rights in and to two patent-pending technologies related to methods for improving tumor-infiltrating lymphocytes for adoptive cell therapy. The licensed technologies relate to the more potent and efficient production of TIL from melanoma tumors by selecting for T-cell populations that express various inhibitory receptors. Unless terminated sooner, the license shall remain in effect until the last licensed patent right expires.
In consideration for the exclusive rights granted under the exclusive Patent License Agreement, the Company agreed to pay the NIH a non-refundable upfront licensing fee of $40,000, which was recognized as research and development expense during the six months ended June 30, 2015. The Company also agreed to pay customary royalties based on a percentage of net sales (which percentage is in the mid-single digits), a percentage of revenues from sublicensing arrangements, and lump sum benchmark payments upon the successful completion of the Company's first Phase 2 clinical study, the successful completion of the Company's first Phase 3 clinical study, the receipt of the first FDA approval or foreign equivalent for a licensed product or process resulting from the licensed technologies, the first commercial sale of a licensed product or process in the United States, and the first commercial sale of a licensed product or process in any foreign country.
During the six months ended June 30, 2015, there were no net sales subject to certain annual minimum royalty payments or sales that would require us to pay a percentage of revenues from sublicensing arrangements. In addition there were no benchmarks or milestones achieved that would require payment under the lump sum benchmark royalty payments on the achievement of certain clinical and regulatory milestones for each of the various indications.
Manufacturing Service Agreement
In December 2011, the Company entered into a Manufacturing Services Agreement with Lonza Walkersville, Inc. (Lonza) pursuant to which Lonza has agreed to manufacture, package, ship and perform quality assurance and quality control of our TIL therapy. Lonza has commenced developing a commercial-scale manufacturing process for the TIL therapy. The goal is to develop and establish a manufacturing process for the large-scale production of TIL that is in accordance with current Good Manufacturing Practices (cGMP).
During 2015, we issued an additional statements of work (SOW) to Lonza under the Manufacturing Services Agreement. The total cost for services to be provided under the SOW is $1,361,095. During the six months ended June 30, 2015, the Company recognized $1,107,453 of expenses under the Manufacturing Services Agreement with Lonza and were recorded as part of research and development expenses.
Research Collaboration Agreement
In September, 2014, we entered into a research collaboration agreement with the H. Lee Moffitt Cancer Center and Research Institute, Inc. to jointly engage in transitional research and development of adoptive tumor-infiltrating lymphocyte cell therapy with improved anti-tumor properties and process. The total obligation under the agreement was $1,432,797, of which $358,199 was paid in 2014. During the six-month period ended June 30, 2015, the Company recognized $358,199 in research and development expenses related to this agreement. |
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CASH, MONEY MARKET FUNDS, AND SHORT-TERM INVESTMENTS
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CASH, MONEY MARKET FUNDS, AND SHORT-TERM INVESTMENTS [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
CASH, MONEY MARKET FUNDS, AND SHORT-TERM INVESTMENTS | NOTE 6. CASH, MONEY MARKET FUNDS, AND SHORT-TERM INVESTMENTS
Cash, money market funds, and short-term investments consist of the following;
Money market funds and short-term investments include the following securities with gross unrealized gains and losses:
As of June 30, 2015, the contractual maturities of our money market funds and short-term investments were:
At June 30, 2015, the Company's short-term investments were invested in short-term fixed income debt securities and notes of domestic and foreign high credit issuers and in money market funds. The Company's investment policy limits investments to certain types of instruments such as certificates of deposit, money market instruments, obligations issued by the U.S. government and U.S. government agencies as well as corporate debt securities, and places restrictions on maturities and concentration by type and issuer. At June 30, 2015, the Company's short-term investments totaled $92.3 million, of which approximately 53% were invested in notes of five companies, approximately 27% were invested in notes of other domestic issuers, and approximately 20% were invested in notes of foreign issuers. The average maturity of these notes was 124 days. At June 30, 2015 the Company's money-market funds totaled $7.5 million and were invested in a single fund, the Dreyfus Cash Management Money Market Fund, a no-load money market fund. |
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LEGAL PROCEEDINGS
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LEGAL PROCEEDINGS [Abstract] | |
LEGAL PROCEEDINGS | NOTE 7. LEGAL PROCEEDINGS
On April 23, 2014, the Company received a subpoena from the Securities Exchange Commission (the SEC) that stated that the staff of the SEC is conducting an investigation In the Matter of Galena Biopharma, Inc. File No. HO 12356 (now known as In the Matter of Certain Stock Promotions) and that the subpoena was issued to the Company as part of the foregoing investigation. The SEC's subpoena and accompanying letter do not indicate whether the Company is, or is not, under investigation. We have fully cooperated with the SEC and as of November 2014, we had completed our production of documents in response to the subpoena. To date, the SEC has not requested any further action from the Company.
The subpoena required the Company to give the SEC, among other materials, all communications between anyone at the Company and certain persons and entities (which include investor-relations firms and persons associated with the investor-relations firms), all documents related to the listed persons and entities, all articles regarding the Company posted on certain equity research or other financial websites, and documents and communications related to individuals who post or have posted articles regarding the Company on equity research or other financial websites.
There are no other pending legal proceedings to which the Company is a party or of which its property is the subject. |
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SUBSEQUENT EVENTS
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SUBSEQUENT EVENTS [Abstract] | |
SUBSEQUENT EVENTS | NOTE 8. SUBSEQUENT EVENTS
Share Issuances
In the third quarter of 2015, the Company has received $129,263 in cash from the exercise of warrants for the purchase of 51,705 shares of its common stock. |
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SUMMARY OF SIGNIFICANT ACCOUNTING PRACTICES (Policies)
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Cash and Cash Equivalents | Cash and Cash Equivalents
The Company considers all highly liquid investments with an original maturity of 90 days or less when purchased to be cash equivalents. The carrying amounts reported in the Balance Sheets for cash and cash equivalents are valued at cost, which approximates their fair value. |
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Short-term Investments | Short-term Investments
The Company's short-term investments represent available for sale securities and are recorded at fair value and unrealized gains and losses are recorded within accumulated other comprehensive income (loss). The estimated fair value of the available for sale securities is determined based on quoted market prices or rates for similar instruments. In addition, the cost of debt securities in this category is adjusted for amortization of premium and accretion of discount to maturity. The Company evaluates securities with unrealized losses to determine whether such losses, if any, are other than temporary. |
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Net Income (Loss) Per Share | Net Income (Loss) Per Share
Basic net income (loss) per share is computed by dividing net income (loss) by the weighted average number of common shares outstanding for the period, excluding unvested shares of restricted common stock. Shares of restricted stock subject to vesting are included in basic weighted average common shares outstanding from the time they vest. Diluted earnings per share is computed by dividing the net income applicable to common stock holders by the weighted average number of common shares outstanding plus the number of additional common shares that would have been outstanding if all dilutive potential common shares had been issued, using the treasury stock method. Potential common shares are excluded from the computation when their effect is antidilutive. When calculating diluted net income per share, shares of restricted stock subject to vesting are included in diluted weighted average common shares outstanding as of their grant date.
At June 30, 2015 and 2014, basic and diluted net loss per share are the same, as the effect of potentially dilutive securities was antidilutive. At June 30, 2015, potentially dilutive securities include options to acquire 2,238,877 shares of common stock, warrants to acquire 7,894,419 shares of common stock, preferred stock that can be converted into 1,847,000 shares of common stock, and 591,500 shares of non-vested restricted stock. At June 30, 2014, potentially dilutive securities include options to acquire 868,750 shares of common stock, warrants to acquire 11,427,764 shares of common stock, and preferred stock that can be converted into 2,847,000 shares of common stock. |
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Fair Value Measurements | Fair Value Measurements
Under FASB ASC 820, Fair Value Measurements and Disclosures, fair value is defined as the price at which an asset could be exchanged or a liability transferred in a transaction between knowledgeable, willing parties in the principal or most advantageous market for the asset or liability. Where available, fair value is based on observable market prices or parameters or derived from such prices or parameters. Where observable prices or parameters are not available, valuation models are applied.
Assets and liabilities recorded at fair value in our financial statements are categorized based upon the level of judgment associated with the inputs used to measure their fair value. Hierarchical levels directly related to the amount of subjectivity associated with the inputs to fair valuation of these assets and liabilities, are as follows:
Level 1Inputs are unadjusted, quoted prices in active markets for identical assets at the reporting date. Active markets are those in which transactions for the asset or liability occur in sufficient frequency and volume to provide pricing information on an ongoing basis.
The fair valued assets we hold that are generally included under this Level 1 are money market securities where fair value is based on publicly quoted prices.
Level 2Are inputs, other than quoted prices included in Level 1, that are either directly or indirectly observable for the asset or liability through correlation with market data at the reporting date and for the duration of the instrument's anticipated life.
The fair valued assets we hold that are generally assessed under Level 2 corporate bonds and commercial paper. We utilize third party pricing services in developing fair value measurements where fair value is based on valuation methodologies such as models using observable market inputs, including benchmark yields, reported trades, broker/dealer quotes, bids, offers and other reference data. We use quotes from external pricing service providers and other on-line quotation systems to verify the fair value of investments provided by our third party pricing service providers. We review independent auditor's reports from our third party pricing service providers particularly regarding the controls over pricing and valuation of financial instruments and ensure that our internal controls address certain control deficiencies, if any, and complementary user entity controls are in place.
Level 3Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities and which reflect management's best estimate of what market participants would use in pricing the asset or liability at the reporting date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model.
We do not have fair valued assets classified under Level 3. |
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Fair Value on a Recurring Basis | Fair Value on a Recurring Basis
Financial assets measured at fair value on a recurring basis are categorized in the tables below based upon the lowest level of significant input to the valuations:
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Use of Estimates | Use of Estimates
The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates. Significant estimates include accounting for potential liabilities and the assumptions made in valuing stock instruments issued for services. |
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Stock-Based Compensation | Stock-Based Compensation
The Company periodically grants stock options and warrants to employees and non-employees in non-capital raising transactions as compensation for services rendered. The Company accounts for stock option grants to employees based on the authoritative guidance provided by the Financial Accounting Standards Board where the value of the award is measured on the date of grant and recognized over the vesting period. The Company accounts for stock option grants to non-employees in accordance with the authoritative guidance of the Financial Accounting Standards Board where the value of the stock compensation is determined based upon the measurement date at either a) the date at which a performance commitment is reached, or b) at the date at which the necessary performance to earn the equity instruments is complete. Non-employee stock-based compensation charges generally are amortized over the vesting period on a straight-line basis. In certain circumstances where there are no future performance requirements by the non-employee, option grants are immediately vested and the total stock-based compensation charge is recorded in the period of the measurement date.
The fair value of the Company's common stock option grants is estimated using a Black-Scholes option pricing model, which uses certain assumptions related to risk-free interest rates, expected volatility, expected life of the common stock options, and future dividends. Compensation expense is recorded based upon the value derived from the Black-Scholes option pricing model, and based on actual experience. The assumptions used in the Black-Scholes option pricing model could materially affect compensation expense recorded in future periods. |
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Research and Development | Research and Development
Research and development costs consist primarily of fees paid to consultants and outside service providers, patent fees and costs, and other expenses relating to the acquisition, design, development and testing of the Company's treatments and product candidates. Research and development costs are expensed as incurred over the life of the underlying contracts on the straight-line basis, unless the achievement of milestones, the completion of contracted work, or other information indicates that a different expensing schedule is more appropriate. The Company reviews the status of its research and development contracts on a quarterly basis. |
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Concentrations | Concentrations
Financial instruments, which potentially subject the Company to concentrations of credit risk, consist principally of cash and short-term investments.
The Company maintains cash balances at more than one bank. As of June 30, 2015, the Company's cash balances were in excess of insured limits maintained at these banks. Management believes that the financial institutions that hold the Company's cash are financially sound and, accordingly, minimal credit risk exists.
At June 30, 2015, the Company's short-term investments were invested in short-term fixed income debt securities of domestic and foreign high credit issuers and in money market funds. The Company's investment policy limits investments to certain types of instruments such as certificates of deposit, money market instruments, obligations issued by the U.S. government and U.S. government agencies as well as corporate debt securities, and places restrictions on maturities and concentration by type and issuer. At June 30, 2015, approximately 53% of the Company's short-term investments were invested in notes of five companies, approximately 27% were invested in notes of various other domestic issuers, and approximately 20% were invested in notes of a foreign issuer. The average maturity of these notes was 124 days (See Note 6). |
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Comprehensive Income (Loss) | Comprehensive Income (Loss)
Components of comprehensive income or loss, including net income or loss, are reported in the financial statements in the period in which they are recognized. Comprehensive income or loss is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. Net income (loss) and other comprehensive income (loss) are reported net of any related tax effect to arrive at comprehensive income (loss). For the three and six months ended June 30, 2015, the Company recorded comprehensive income of $21,704 for unrealized gains on short term investments. The Company did not have any items of comprehensive income (loss) for the three months and six months ended June 30, 2014. |
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Recent Accounting Pronouncements | Recent Accounting Pronouncements
In May 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2014-09, Revenue from Contracts with Customers. ASU 2014-09 is a comprehensive revenue recognition standard that will supersede nearly all existing revenue recognition guidance under current U.S. GAAP and replace it with a principle based approach for determining revenue recognition. ASU 2014-09 will require that companies recognize revenue based on the value of transferred goods or services as they occur in the contract. The ASU also will require additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. ASU 2014-09 is effective for interim and annual periods beginning after December 15, 2017. Early adoption is permitted in annual reporting periods beginning after December 15, 2016, and the interim periods within that year, and either full retrospective adoption or modified retrospective adoption is permitted. The Company is in the process of evaluating the impact of ASU 2014-09 on the Company's financial statements and disclosures.
In June 2014, the FASB issued Accounting Standards Update No. 2014-12, Compensation Stock Compensation (Topic 718). The pronouncement was issued to clarify the accounting for share-based payments when the terms of an award provide that a performance target could be achieved after the requisite service period. The pronouncement is effective for reporting periods beginning after December 15, 2015. The adoption of ASU 2014-12 is not expected to have a significant impact on the Company's consolidated financial position or results of operations.
In November 2014, the FASB issued Accounting Standards Update No. 2014-16, Determining Whether the Host Contract in a Hybrid Financial Instrument Issued in the Form of a Share Is More Akin to Debt or to Equity. The amendments in ASU 2014-6 do not change the current criteria in U.S. GAAP for determining when separation of certain embedded derivative features in a hybrid financial instrument is required. The amendments clarify that an entity should consider all relevant terms and features, including the embedded derivative feature being evaluated for bifurcation, in evaluating the nature of the host contract. ASU 2014-6 applies to all entities that are issuers of, or investors in, hybrid financial instruments that are issued in the form of a share and is effective for public business entities for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2015. Early adoption is permitted. The Company is currently evaluating the impact the adoption of ASU 2014-16 on the Company's financial statements and disclosures.
Other recent accounting pronouncements issued by the FASB, including its Emerging Issues Task Force, the American Institute of Certified Public Accountants, and the Securities and Exchange Commission did not or are not believed by management to have a material impact on the Company's present or future consolidated financial statements. |
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Reclassifications | Reclassifications
In presenting the Company's statement of operations for the three and six month periods ended June 30, 2014, the Company has reclassified $551,561 and $132,767, respectively, of stock-based compensation that was previously reflected as operating expenses to research and development expenses. The reclassification relates to stock-based compensation to individuals working in the Company's research and development activities, and had no impact on total costs and expenses or net loss. |
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SUMMARY OF SIGNIFICANT ACCOUNTING PRACTICES (Tables)
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6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2015
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SUMMARY OF SIGNIFICANT ACCOUNTING PRACTICES [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Assets Measured at Fair Value |
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STOCKHOLDERS' EQUITY (Tables)
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Jun. 30, 2015
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STOCKHOLDERS' EQUITY [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Restricted Stock Activity |
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STOCK OPTIONS AND WARRANTS (Tables)
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Jun. 30, 2015
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STOCK OPTIONS AND WARRANTS [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Status of Stock Options |
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Schedule of Status of Stock Warrants |
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CASH, MONEY MARKET FUNDS, AND SHORT-TERM INVESTMENTS (Tables)
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6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2015
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CASH, MONEY MARKET FUNDS, AND SHORT-TERM INVESTMENTS [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Cash, Money Market Funds and Short-Term Investments |
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Schedule of Unrealized Gains and Losses |
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Schedule of Contractual Maturities |
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GENERAL ORGANIZATION AND BUSINESS (Details) (USD $)
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1 Months Ended | 3 Months Ended | 6 Months Ended | ||||||
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May 06, 2015
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Mar. 03, 2015
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Dec. 22, 2014
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Nov. 05, 2013
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Jun. 30, 2015
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Jun. 30, 2014
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Jun. 30, 2015
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Jun. 30, 2014
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Dec. 31, 2014
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GENERAL ORGANIZATION AND BUSINESS [Abstract] | |||||||||
Net loss | $ (6,367,490) | $ (2,110,169) | $ (11,665,550) | $ (4,369,683) | |||||
Net cash used in operating activities | (7,958,579) | (3,589,554) | |||||||
Cash, money market funds and short-term investments | 112,336,127 | 112,336,127 | 44,909,147 | ||||||
Stockholder's equity | 112,873,396 | 112,873,396 | 44,845,087 | ||||||
Working capital | 110,848,000 | 110,848,000 | |||||||
Shares issued during period | 4,750,000 | 9,200,000 | 6,000,000 | ||||||
Share price | $ 10.00 | $ 8.00 | $ 5.75 | ||||||
Proceeds from the issuance of common stock, net | 32,200,000 | 68,307,838 | |||||||
Proceeds from issuance of private placement | $ 23,300,000 |
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STOCKHOLDERS' EQUITY (Narrative) (Details) (USD $)
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1 Months Ended | 6 Months Ended | 12 Months Ended | 6 Months Ended | ||||
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May 06, 2015
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Mar. 03, 2015
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Dec. 22, 2014
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Jun. 30, 2015
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Jun. 30, 2014
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Jun. 30, 2015
Restricted Stock [Member]
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Dec. 31, 2014
Restricted Stock [Member]
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Jun. 30, 2015
Series A Convertible Preferred Stock [Member]
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Class of Stock [Line Items] | ||||||||
Shares issued during period | 4,750,000 | 9,200,000 | 6,000,000 | |||||
Share price | $ 10.00 | $ 8.00 | $ 5.75 | |||||
Proceeds from the issuance of common stock, net | $ 32,200,000 | $ 68,307,838 | ||||||
Conversion of Stock, Shares Issued | 1,000,000 | |||||||
Conversion of Stock, Shares Converted | 2,000 | 500 | ||||||
Granted | 782,500 | |||||||
Vesting period | 3 years | |||||||
Nonvested, fair value | 5,080,090 | |||||||
Share-based compensation | 2,301,297 | 1,340,601 | 1,256,985 | |||||
Vested, fair value | 1,087,870 | |||||||
Unrecognized compensation cost | $ 2,948,985 |
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STOCKHOLDER'S EQUITY (Schedule of Restricted Stock Activity) (Details) (USD $)
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6 Months Ended |
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Jun. 30, 2015
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Number of Shares | |
Non-vested shares, January 1, 2015 | 742,500 |
Granted | |
Vested | (126,000) |
Forfeited | (25,000) |
Non-vested shares, June 30, 2015 | 591,500 |
Weighted Average Grant Date Fair Value | |
Non-vested shares, January 1, 2015 | $ 6.98 |
Granted | |
Vested | $ 6.55 |
Forfeited | $ 8.55 |
Non-vested shares, June 30, 2015 | $ 6.90 |
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STOCK OPTIONS AND WARRANTS (Narrative) (Details) (USD $)
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6 Months Ended | 1 Months Ended | 6 Months Ended | ||||||
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Jun. 30, 2015
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Jun. 30, 2014
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Jun. 30, 2015
Warrant [Member]
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Mar. 29, 2010
2010 Plan [Member]
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Apr. 10, 2015
2014 Plan [Member]
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Nov. 30, 2014
2014 Plan [Member]
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Jun. 30, 2015
Minimum [Member]
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Jun. 30, 2015
Maximum [Member]
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Jun. 30, 2015
Director [Member]
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Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Number of shares authorized | 35,000 | 4,000,000 | 2,350,000 | ||||||
Number of additional shares authorized | 1,650,000 | ||||||||
Share-based compensation | $ 2,301,297 | $ 1,340,601 | |||||||
Unrecognized compensation cost | 11,196,570 | ||||||||
Unrecognized compensation cost, period for recognition | 6 months | 3 years | |||||||
Proceeds from warrant exercises | 7,975,150 | 2,363,480 | |||||||
Purchase of common stock | 3,190,007 | ||||||||
Fair value of options | $ 4,701,113 | ||||||||
Expected volatility | 218.00% | ||||||||
Discount rate | 1.57% | ||||||||
Expected dividend yield | 0.00% | ||||||||
Expected life | 6 years | ||||||||
Vesting period | 1 year | 3 years |
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STOCK OPTIONS AND WARRANTS (Schedule of Status of Stock Options) (Details) (Employee Stock Option [Member], USD $)
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6 Months Ended | 12 Months Ended |
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Jun. 30, 2015
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Dec. 31, 2014
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Employee Stock Option [Member]
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Shares Under Option | ||
Outstanding, beginning balance | 1,857,877 | |
Granted | 452,250 | |
Exercised | ||
Expired/Forfeited | (71,250) | |
Outstanding, ending balance | 2,238,877 | 1,857,877 |
Exercisable | 760,725 | |
Weighted Average Exercise Price | ||
Outstanding, beginning balance | $ 7.31 | |
Granted | $ 10.39 | |
Exercised | ||
Expired/Forfeited | $ 7.26 | |
Outstanding, ending balance | $ 8.06 | $ 7.31 |
Exercisable | $ 8.96 | |
Weighted Average Remaining Contractual Life | ||
Outstanding, beginning balance | 8 years 1 month 13 days | 8 years 2 months 12 days |
Granted | 10 years | |
Expired/Forfeited | 9 years 2 months 12 days | |
Outstanding, ending balance | 8 years 1 month 13 days | 8 years 2 months 12 days |
Exercisable | 6 years 10 months 28 days | |
Aggregate Intrinsic Value | ||
Outstanding, beginning balance | $ 2,874,378 | |
Granted | 102,050 | |
Expired/Forfeited | 27,125 | |
Outstanding, ending balance | 5,052,068 | 2,874,378 |
Exercisable | $ 2,107,877 |
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The total intrinsic value of expirations and forfeitures during the period. No definition available.
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Weighted average remaining contractual term for option awards forfeitures and expirations in period, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. No definition available.
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Weighted average remaining contractual term for option awards grants in period, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. No definition available.
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STOCK OPTIONS AND WARRANTS (Schedule of Status of Stock Warrants) (Details) (Warrant [Member], USD $)
|
6 Months Ended | 12 Months Ended |
---|---|---|
Jun. 30, 2015
|
Dec. 31, 2014
|
|
Warrant [Member]
|
||
Shares Under Warrants | ||
Outstanding, beginning balance | 11,084,426 | |
Issued | ||
Exercised | (3,190,007) | |
Expired | ||
Outstanding, ending balance | 7,894,419 | 11,084,426 |
Exercisable | 7,894,419 | |
Weighted Average Exercise Price | ||
Outstanding, beginning balance | $ 2.51 | |
Exercised | $ 2.50 | |
Outstanding, ending balance | $ 2.51 | $ 2.51 |
Exercisable | $ 2.51 | |
Weighted Average Remaining Contractual Life | ||
Outstanding | 3 years 3 months 29 days | 3 years 10 months 6 days |
Exercisable ending balance | 3 years 3 months 29 days | |
Aggregate Intrinsic Value | ||
Outstanding, beginning balance | $ 59,517,998 | |
Outstanding, ending balance | 52,655,775 | 59,517,998 |
Exercisable ending balance | $ 52,655,775 |
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LICENSE AND COMMITMENTS (Details) (USD $)
|
3 Months Ended | 6 Months Ended | 12 Months Ended | 6 Months Ended | 12 Months Ended | 6 Months Ended | 12 Months Ended | 6 Months Ended | |||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2015
|
Jun. 30, 2014
|
Jun. 30, 2015
|
Jun. 30, 2014
|
Dec. 31, 2014
|
Dec. 31, 2014
Moffitt License Agreement
|
Jun. 30, 2015
Manufacturing Service Agreement [Member]
|
Jun. 30, 2015
Research Collaboration Agreement [Member]
|
Dec. 31, 2014
Research Collaboration Agreement [Member]
|
Jun. 30, 2015
Exclusive Patent License Agreement [Member]
|
Jun. 30, 2015
Crada [Member]
|
Jun. 30, 2014
Crada [Member]
|
Jun. 30, 2015
Crada [Member]
Per Quarter [Member]
|
Jun. 30, 2015
Crada [Member]
Per Year [Member]
|
Jun. 30, 2015
NCI [Member]
|
Jun. 30, 2015
NCI [Member]
Per Quarter [Member]
|
Jun. 30, 2015
NCI [Member]
Per Year [Member]
|
Dec. 31, 2014
NCI [Member]
Per Year [Member]
|
Jun. 30, 2015
NIH [Member]
|
|||||||
License And Commitments [Line Items] | |||||||||||||||||||||||||
Purchase commitment | $ 1,361,095 | $ 1,432,797 | $ 250,000 | $ 1,000,000 | $ 500,000 | $ 2,000,000 | $ 1,000,000 | ||||||||||||||||||
Accrued liabilities | 623,774 | 623,774 | 327,847 | 250,000 | 500,000 | ||||||||||||||||||||
Research and development expense | $ 4,055,688 | [1] | $ 493,994 | [1] | $ 6,841,131 | [1] | $ 1,215,450 | [1] | $ 25,000 | $ 1,107,453 | $ 358,199 | $ 358,199 | $ 40,000 | $ 1,041,667 | $ 500,000 | $ 500,000 | $ 350,000 | ||||||||
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CASH, MONEY MARKET FUNDS, AND SHORT-TERM INVESTMENTS (Schedule of Cash, Money Market Funds, and Short-Term Investments) (Details) (USD $)
|
Jun. 30, 2015
|
Dec. 31, 2014
|
Jun. 30, 2014
|
Dec. 31, 2013
|
---|---|---|---|---|
CASH, MONEY MARKET FUNDS, AND SHORT-TERM INVESTMENTS [Abstract] | ||||
Checking and savings accounts (reported as cash and cash equivalents) | $ 12,556,290 | $ 44,909,147 | $ 18,440,361 | $ 19,672,177 |
Money market funds | 7,476,855 | |||
Corporate debt securities (reported as short-term investments) | 92,302,982 | |||
Total | $ 112,336,127 | $ 44,909,147 |
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