Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2016 | Apr. 20, 2016 | |
Document and Entity Information [Abstract] | ||
Entity Registrant Name | ARQULE INC | |
Entity Central Index Key | 1,019,695 | |
Trading Symbol | arql | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 71,062,822 | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2016 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q1 |
CONDENSED BALANCE SHEETS (Unaud
CONDENSED BALANCE SHEETS (Unaudited) - USD ($) $ in Thousands | Mar. 31, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 19,962 | $ 13,983 |
Marketable securities-short term | 27,680 | 24,789 |
Prepaid expenses and other current assets | 829 | 714 |
Total current assets | 48,471 | 39,486 |
Property and equipment, net | 239 | 266 |
Other assets | 252 | 252 |
Total assets | 48,962 | 40,004 |
Current liabilities: | ||
Accounts payable and accrued expenses | 5,391 | 6,234 |
Deferred revenue | 3,451 | 4,591 |
Total current liabilities | $ 8,842 | $ 10,825 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred stock, $0.01 par value; 1,000,000 shares authorized; no shares issued or outstanding | ||
Common stock, $0.01 par value; 100,000,000 shares authorized; 71,062,822 and 62,939,780 shares issued and outstanding at March 31, 2016 and December 31, 2015, respectively | $ 711 | $ 629 |
Additional paid-in capital | 526,475 | 510,664 |
Accumulated other comprehensive income | 32 | 3 |
Accumulated deficit | (487,098) | (482,117) |
Total stockholders' equity | 40,120 | 29,179 |
Total liabilities and stockholders' equity | $ 48,962 | $ 40,004 |
CONDENSED BALANCE SHEETS (Unau3
CONDENSED BALANCE SHEETS (Unaudited) (Parentheticals) - $ / shares | Mar. 31, 2016 | Dec. 31, 2015 |
Statement Of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 1,000,000 | 1,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 71,062,822 | 62,939,780 |
Common stock, shares outstanding | 71,062,822 | 62,939,780 |
CONDENSED STATEMENTS OF OPERATI
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Revenue | ||
Research and development revenue | $ 1,227 | $ 2,785 |
Costs and expenses: | ||
Research and development | 4,198 | 4,413 |
General and administrative | 2,044 | 3,187 |
Total costs and expenses | 6,242 | 7,600 |
Loss from operations | (5,015) | (4,815) |
Interest income | 34 | 36 |
Other income | 228 | |
Net loss | (4,981) | (4,551) |
Unrealized gain on marketable securities | 29 | 11 |
Comprehensive loss | $ (4,952) | $ (4,540) |
Basic and diluted net loss per share: | ||
Net loss per share | $ (0.08) | $ (0.07) |
Weighted average basic and diluted common shares outstanding | 65,489 | 62,745 |
CONDENSED STATEMENTS OF CASH FL
CONDENSED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Cash flows from operating activities: | ||
Net loss | $ (4,981) | $ (4,551) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 27 | 47 |
Amortization of premium on marketable securities | 26 | 189 |
Amortization of deferred gain on sale leaseback | (140) | |
Non-cash stock compensation | 594 | 818 |
Gain on sale of property and equipment | (228) | |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | (115) | 525 |
Accounts payable and accrued expenses | (843) | (1,441) |
Deferred revenue | (1,140) | (2,773) |
Net cash used in operating activities | (6,432) | (7,554) |
Cash flows from investing activities: | ||
Purchases of marketable securities | (13,386) | (3,387) |
Proceeds from sale or maturity of marketable securities | 10,498 | 18,570 |
Additions to property and equipment | (52) | |
Proceeds from sale of property and equipment | 99 | |
Net cash provided by (used in) investing activities | (2,888) | 15,230 |
Cash flows from financing activities: | ||
Proceeds from stock offering, net | 15,185 | |
Proceeds from stock option exercises and employee stock plan purchases | 114 | |
Net cash provided by financing activities | 15,299 | |
Net increase in cash and cash equivalents | 5,979 | 7,676 |
Cash and cash equivalents, beginning of period | 13,983 | 12,525 |
Cash and cash equivalents, end of period | $ 19,962 | $ 20,201 |
NATURE OF OPERATIONS AND BASIS
NATURE OF OPERATIONS AND BASIS OF PRESENTATION | 3 Months Ended |
Mar. 31, 2016 | |
Organization and Nature Of Operations [Abstract] | |
NATURE OF OPERATIONS AND BASIS OF PRESENTATION | 1. NATURE OF OPERATIONS AND BASIS OF PRESENTATION We are a biopharmaceutical company engaged in the research and development of innovative therapeutics to treat cancers and rare diseases. Our mission is to discover, develop and commercialize novel small molecule drugs in areas of high unmet need that will dramatically extend and improve the lives of our patients. These drugs target biological pathways implicated in a wide range of cancers and certain non-oncology indications. Our discovery and development efforts are guided, when possible, by an understanding of the role of biomarkers, which are indicators of a particular biological condition or process and may predict the clinical benefit of our compounds in defined patient populations. Our proprietary clinical-stage pipeline consists of four drug candidates, all of which are in targeted patient populations, making ArQule a leader among companies our size in precision medicine. Our lead product candidate is tivantinib (ARQ 197), an orally administered, small molecule inhibitor of the c-Met receptor tyrosine kinase (“MET”) and its biological pathway. MET is a promising target for cancer therapy, based on its multiple roles in cancerous cell proliferation, tumor spread, new blood vessel formation and resistance to certain drug therapies. We and our partners, Daiichi Sankyo Co., Ltd. (“Daiichi Sankyo”) and Kyowa Hakko Kirin Co., Ltd. (“Kyowa Hakko Kirin”), are implementing a worldwide clinical development program with tivantinib. Our strategy is to focus on the most promising indications within our clinical programs based upon continually generated and updated clinical and pre-clinical data. Our lead indication is liver cancer (“hepatocellular carcinoma” or “HCC”), and we are currently conducting two Phase 3 trials with our partners. We have also completed earlier-stage single agent and combination therapy trials and pre-clinical experiments with tivantinib and other anti-cancer agents that may provide data to support trials in additional indications. On March 22, 2016, we and Daiichi Sankyo announced that the independent data monitoring committee (“DMC”) of the METIV-HCC study conducted the planned interim assessment, and it was determined the trial will continue to its final analysis. Accordingly, we reviewed the estimated development period and extended it to December 2016 for both the METIV-HCC trial and the JET-HCC trial. We have licensed commercial rights to tivantinib for human cancer indications to Daiichi Sankyo in the U.S., Europe, South America and the rest of the world, excluding Japan and certain other Asian countries, where we have licensed commercial rights to Kyowa Hakko Kirin. Our agreements with these partners provide for possible future milestone payments, royalties on product sales, and development funding, in addition to significant payments that we have already received. To date we have received $100 million in upfront and milestone payments from Daiichi Sankyo, $15 million of which was related to the first patient enrolled in the METIV-HCC trial. That milestone was netted against our cumulative share of Phase 3 collaboration costs in 2013, and consequently we did not receive any cash proceeds from this milestone. To date, we have received $48 million in upfront and milestone payments from Kyowa Hakko Kirin. Our proprietary pipeline of product candidates is directed toward molecular targets and biological processes with demonstrated roles in the development of both human cancers and rare, non-oncology diseases. These product candidates include: ARQ 092, designed to inhibit the AKT serine/threonine kinase; ARQ 087, a multi-kinase inhibitor designed to preferentially inhibit the fibroblast growth factor receptor (“FGFR”) family; and ARQ 761, a Beta lapachone analog being evaluated in investigator-sponsored testing as a promoter of NQO1-mediated programmed cancer cell necrosis. We expect to add to our proprietary pipeline with the initiation of a Phase 1 clinical trial in oncology with our next generation AKT inhibitor, ARQ 751, in the first half of 2016. Specific tumor types and biomarkers have been identified to guide our clinical testing, based on analyses of Phase 1a anti-cancer activity in humans, preclinical findings and scientific literature. Our uses of cash for operating activities have primarily consisted of salaries and wages for our employees, facility and facility-related costs for our offices and laboratories, fees paid in connection with preclinical and clinical studies, laboratory supplies and materials, and professional fees. The sources of our cash flow from operating activities have consisted primarily of payments received from our collaborators for services performed or upfront payments for future services. For the quarters ended March 31, 2016 and 2015, our net use of cash was primarily driven by payments for operating expenses which resulted in net cash outflows of $6.4 million and $7.6 million, respectively. Our cash requirements may vary materially from those now planned depending upon the results of our drug discovery and development strategies, our ability to enter into additional corporate collaborations and the terms of such collaborations, results of research and development, unanticipated required capital expenditures, competitive and technological advances, acquisitions and other factors. We cannot guarantee that we will be able to develop any of our drug candidates into a commercial product. It is likely we will need to raise additional capital or incur indebtedness to continue to fund our operations in the future. Our ability to raise additional funds will depend on financial, economic and market conditions, and due to global capital and credit market conditions or for other reasons, we may be unable to raise capital when needed, or on terms favorable to us. If necessary funds are not available, we may have to delay, reduce the scope of, or eliminate some of our development programs, potentially delaying the time to market for any of our product candidates. We have prepared the accompanying condensed financial statements pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been condensed or omitted pursuant to these rules and regulations. These condensed financial statements should be read in conjunction with our audited financial statements and footnotes related thereto for the year ended December 31, 2015 included in our annual report on Form 10-K filed with the SEC on February 29, 2016. In the opinion of the Company, the accompanying unaudited condensed financial statements contain all adjustments, consisting only of normal recurring adjustments, necessary for a fair statement of its financial position as of March 31, 2016, and its results of operations and cash flows for the three months ended March 31, 2016 and March 31, 2015. The results of operations for such interim periods are not necessarily indicative of the results to be achieved for the full year. The condensed balance sheet at December 31, 2015, was derived from audited annual financial statements, but does not contain all of the footnote disclosures from the annual financial statements. |
COLLABORATIONS AND ALLIANCES
COLLABORATIONS AND ALLIANCES | 3 Months Ended |
Mar. 31, 2016 | |
Organization, Consolidation and Presentation Of Financial Statements [Abstract] | |
COLLABORATIONS AND ALLIANCES | 2. COLLABORATIONS AND ALLIANCES Daiichi Sankyo Tivantinib Agreement On December 18, 2008, we entered into a license, co-development and co-commercialization agreement with Daiichi Sankyo to conduct research, clinical trials and the commercialization of tivantinib in human cancer indications in the U.S., Europe, South America and the rest of the world, excluding Japan, China (including Hong Kong), South Korea and Taiwan, where Kyowa Hakko Kirin has exclusive rights for development and commercialization. The agreement provides for a $60 million cash upfront licensing payment from Daiichi Sankyo to us, which we received in December 2008, and an additional $560 million in potential development and sales milestone payments offset by our share of Phase 3 costs. On November 3, 2015, the Company announced that it had exercised its option with Daiichi Sankyo to co-commercialize tivantinib in the United States (the “Co-Commercialization Option”), pursuant to the agreement. Subject to the receipt of regulatory approvals, the first commercial indication for tivantinib under the Co-Commercialization Option is anticipated to be second line HCC. The parties have a prescribed period to conclude a co-commercialization agreement in accordance with the terms of the agreement which is expected to occur in 2016. If the METIV-HCC trial is successful, and tivantinib is approved in second line HCC, the agreement provides that the Company will receive a total of $55 million in milestone payments for the official acceptance of drug approval applications by FDA and the European Medicines Agency (“EMA”) in this first indication, plus an additional $100 million in combined milestones tied to receipt of commercialization regulatory approval by the FDA and the first commercial sale in the UK, Germany, France, Italy or Spain. These milestones, totaling $155 million, will be partially offset by Phase 3 costs owed to Daiichi Sankyo by the Company at the time of approval in the US or EU. At March 31, 2016, the Company’s share of these Phase 3 costs totaled $63.3 million. The agreement also provides that the Company will receive tiered double digit royalties on net sales of tivantinib throughout the territory. Given the anticipated commercial market for second line HCC, the Company expects to earn royalties on net sales for this indication at the baseline contractual rate of 20 percent. We and Daiichi Sankyo will share equally the costs of Phase 2 and Phase 3 clinical studies, with our share of Phase 3 costs payable solely from milestone and royalty payments by Daiichi Sankyo. Under the terms of our tivantinib collaboration agreement with Daiichi Sankyo we share development costs equally with our share of Phase 3 costs funded solely from milestones and royalties. In each quarter the tivantinib collaboration costs we incur are compared with those of Daiichi Sankyo. If our costs for the quarter exceed Daiichi Sankyo’s, we recognize revenue on the amounts due to us under the contingency adjusted performance model. Revenue is calculated on a pro-rata basis using the time elapsed from inception of the agreement over the estimated duration of the development period under the agreement. If our costs for the quarter are less than those of Daiichi Sankyo’s, we report the amount due to Daiichi Sankyo as contra-revenue in that quarter. To the extent that our share of Phase 3 collaboration costs exceeds the amount of milestones and royalties received, that excess is netted against future milestones and royalties if and when earned and is not reported as contra-revenue. Our cumulative share of the Daiichi Sankyo Phase 3 costs through March 31, 2016 totaled $103.3 million. We received a milestone of $25 million in February 2011 upon enrolling the first patient in the MARQUEE trial, the cash proceeds of which were subsequently applied to our share of Phase 3 collaboration costs. On January 31, 2013, we announced that the first patient had been enrolled in the pivotal Phase 3 METIV trial of tivantinib, entitling us to a $15 million milestone. That $15 million milestone was also netted against our cumulative share of Phase 3 collaboration costs in 2013, and consequently we did not receive any cash proceeds from this milestone. Our cumulative share of Phase 3 collaboration costs has exceeded the amount of milestones received through March 31, 2016 by $63.3 million which will be netted against future milestones and royalties, if any, when earned and has not been reported as contra-revenue. For the quarter ended March 31, 2016, our non-Phase 3 tivantinib collaboration costs incurred exceeded those of Daiichi Sankyo’s and $79 was recognized as tivantinib Daiichi Sankyo research and development revenue. For the quarter ended March 31, 2015, our non-Phase 3 tivantinib collaboration costs incurred exceeded those of Daiichi Sankyo’s and $10 was recognized as tivantinib Daiichi Sankyo research and development revenue. The duration and termination of the agreement are tied to future events. Unless earlier terminated due to breach, insolvency or upon 90 days’ notice if prior to Phase 3 clinical trials or 180 days’ notice if on or after the beginning of Phase 3 clinical trials by Daiichi Sankyo, the agreement shall continue until the later of (i) such time as Daiichi Sankyo is no longer developing at least one licensed product or (ii) if Daiichi Sankyo has commercialized a licensed product or products, such time as all royalty terms for all licensed products have ended. The royalty term, on a country-by-country basis for a product, ends as of the later of (i) the expiration of the last valid claim under a patent covering the manufacture, use, or sale of a licensed product or (ii) a certain number of years from the date of the commercial sale of the licensed product in such country. Revenue for this agreement is recognized using the contingency-adjusted performance model. Through September 30, 2012, revenue was recognized based upon an estimated development period through December 2013. As a result of the October 2012 decision to discontinue the MARQUEE trial, the development period as of October 1, 2012 was extended to June 2015. Commencing with the fourth quarter of 2012 and through the third quarter of 2013 revenue was recognized over that development period. In the fourth quarter of 2013, following a recommendation by DMC that the METIV-HCC trial continue with patients receiving a lower dose of tivantinib than the dose originally employed in the trial, we reviewed the estimated development period and extended it to June 2016. On March 22, 2016, we and Daiichi Sankyo announced that the DMC of the METIV-HCC study conducted the planned interim assessment, and it was determined the trial will continue to its final analysis. Accordingly, we reviewed the estimated development period and extended it to December 2016. For the quarters ended March 31, 2016 and 2015, $0.7 million and $1.4 million, respectively, were recognized as net revenue. At March 31, 2016, $2.1 million remains in deferred revenue. Kyowa Hakko Kirin Licensing Agreement On April 27, 2007, we entered into an exclusive license agreement with Kyowa Hakko Kirin to develop and commercialize tivantinib in Japan and parts of Asia. A $3 million portion of an upfront licensing fee was received by the Company under this agreement in the first quarter of 2007, and an additional $27 million in upfront licensing fees was received on May 7, 2007. The agreement includes $123 million in upfront and potential development milestone payments from Kyowa Hakko Kirin to ArQule, including the $30 million cash upfront licensing payments. In February 2008, we received a $3 million milestone payment from Kyowa Hakko Kirin. Upon commercialization, ArQule will receive tiered royalties in the mid-teen to low-twenty percent range from Kyowa Hakko Kirin on net sales of tivantinib. Kyowa Hakko Kirin will be responsible for all clinical development costs and commercialization of the compound in certain Asian countries, consisting of Japan, China (including Hong Kong), South Korea and Taiwan. In July 2010, we announced the initiation of a Phase 2 trial with tivantinib by Kyowa Hakko Kirin in gastric cancer, for which we received a $5 million milestone payment in September 2010. In August 2011, Kyowa Hakko Kirin announced the initiation of the Phase 3 ATTENTION trial. Dosing of the first patient in this trial triggered a $10 million milestone payment, which we received in August 2011. The milestone payment was recorded as deferred revenue and is being recognized as revenue using the contingency-adjusted performance model. On February 4, 2014, Kyowa Hakko Kirin announced the initiation of the Phase 3 JET-HCC trial. There were no milestone payments associated with the initiation of this trial. In addition to the upfront and possible regulatory milestone payments totaling $123 million, the Company will be eligible for future milestone payments based on the achievement of certain levels of net sales. The Company will recognize the payments, if any, as revenue in accordance with the contingency-adjusted performance model. As of March 31, 2016, the Company had not recognized any revenue from these sales milestone payments, and there can be no assurance that it will do so in the future. The duration and termination of the agreement are tied to future events. Unless earlier terminated due to breach, insolvency or upon 90 days’ notice by Kyowa Hakko Kirin, the agreement terminates on the date that the last royalty term expires in all countries in the territory. The royalty term ends as of the later of (i) the expiration of the last pending patent application or expiration of the patent in the country covering the manufacture, use, or sale of a licensed product or (ii) a certain number of years from the date of the commercial launch in such country of such license product. Through December 2015, revenue for this agreement was recognized using the contingency-adjusted performance model with an estimated development period through April 2016. As noted for the Daiichi Sankyo tivantinib program, the estimated development period for the METIV-HCC study was reviewed and extended to December 2016 in the first quarter of 2016. Similarly, the estimated development period for the Kyowa Hakko Kirin Phase 3 JET-HCC trial was reviewed and also extended to December 2016. For the quarters ended March 31, 2016 and 2015, $0.5 million and $1.4 million, respectively, were recognized as revenue. At March 31, 2016, $1.4 million remains in deferred revenue. Beryllium Discovery Corp. Agreement In May 2015, we entered into a collaborative research and development agreement with Beryllium Discovery Corp. (“Beryllium”). Pursuant to the agreement, we will jointly focus on the identification and preclinical development of inhibitors of PD-1 and PDL-1. We and Beryllium will each be responsible for our respective internal and outsourcing costs during pre-clinical development. Following lead optimization of any potential drug candidates, we and Beryllium will jointly decide whether to advance compounds into GLP/toxicology and clinical testing, initially on a shared cost basis, provided that we will have the right to advance compounds on our own should Beryllium vote against such advancement. The agreement also provides that we will be responsible for clinical development and commercialization of product candidates that are not out-licensed. Beryllium will have the right to participate financially throughout the program but will also have the option to opt out at certain times and receive a royalty. The agreement will terminate after the last payment obligation is satisfied, or prior to that upon 60-days’ notice by either party. |
MARKETABLE SECURITIES AND FAIR
MARKETABLE SECURITIES AND FAIR VALUE MEASUREMENTS | 3 Months Ended |
Mar. 31, 2016 | |
Marketable Securities and Fair Value Measurements [Abstract] | |
MARKETABLE SECURITIES AND FAIR VALUE MEASUREMENTS | 3. MARKETABLE SECURITIES AND FAIR VALUE MEASUREMENTS We generally classify our marketable securities as available-for-sale at the time of purchase and re-evaluate such designation as of each balance sheet date. Since we generally intend to convert them into cash as necessary to meet our liquidity requirements our marketable securities are classified as cash equivalents if the original maturity, from the date of purchase, is ninety days or less and as short-term investments if the original maturity, from the date of purchase, is in excess of ninety days but less than one year. Our marketable securities are classified as long-term investments if the maturity date is in excess of one year of the balance sheet date. We report available-for-sale investments at fair value as of each balance sheet date and include any unrealized gains and, to the extent deemed temporary, unrealized losses in stockholders’ equity. Realized gains and losses are determined using the specific identification method and are included in other income (expense) in the statement of operations and comprehensive loss. We conduct quarterly reviews to determine the fair value of our investment portfolio and to identify and evaluate each investment that has an unrealized loss, in accordance with the meaning of other-than-temporary impairment and its application to certain investments. An unrealized loss exists when the current fair value of an individual security is less than its amortized cost basis. In the event that the cost basis of a security exceeds its fair value, we evaluate, among other factors, the duration of the period that, and extent to which, the fair value is less than cost basis, the financial health of and business outlook for the issuer, including industry and sector performance, and operational and financing cash flow factors, overall market conditions and trends, our intent to sell the investment and if it is more likely than not that we would be required to sell the investment before its anticipated recovery. Unrealized losses on available-for-sale securities that are determined to be temporary, and not related to credit loss, are recorded in accumulated other comprehensive income (loss). For available-for-sale debt securities with unrealized losses, we perform an analysis to assess whether we intend to sell or whether we would more likely than not be required to sell the security before the expected recovery of the amortized cost basis. Where we intend to sell a security, or may be required to do so, the security’s decline in fair value is deemed to be other-than-temporary and the full amount of the unrealized loss is reflected in the statement of operations and comprehensive loss as an impairment loss. Regardless of our intent to sell a security, we perform additional analysis on all securities with unrealized losses to evaluate losses associated with the creditworthiness of the security. Credit losses are identified where we do not expect to receive cash flows sufficient to recover the amortized cost basis of a security. The following is a summary of the fair value of available-for-sale marketable securities we held at March 31, 2016 and December 31, 2015: March 31, 2016 Amortized Gross Gross Fair Security type Corporate debt securities-short term $ 27,648 $ 33 $ (1 ) $ 27,680 Total available-for-sale marketable securities $ 27,648 $ 33 $ (1 ) $ 27,680 December 31, 2015 Amortized Gross Gross Fair Security type Corporate debt securities-short term $ 24,786 $ 13 $ (10 ) $ 24,789 Total available-for-sale marketable securities $ 24,786 $ 13 $ (10 ) $ 24,789 Our available-for-sale marketable securities in a loss position at March 31, 2016, and December 31, 2015 were in a continuous unrealized loss position for less than 12 months. The following tables present information about our assets that are measured at fair value on a recurring basis for the periods presented and indicates the fair value hierarchy of the valuation techniques we utilized to determine such fair value. In general, fair values determined by Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities. Fair values determined by Level 2 inputs utilize data points that are observable such as quoted prices, interest rates and yield curves. We value our level 2 investments using quoted prices for identical assets in the markets where they are traded, although such trades may not occur daily. These quoted prices are based on observable inputs, primarily interest rates. Fair values determined by Level 3 inputs are unobservable data points for the asset or liability, and include situations where there is little, if any, market activity for the asset or liability. There were no transfers in or out of Level 1 or Level 2 measurements for the periods presented: March 31, Quoted Significant Significant Cash equivalents $ 15,976 $ 15,976 $ — $ — Corporate debt securities-short term 27,680 — 27,680 — Total $ 43,656 $ 15,976 $ 27,680 $ — December 31, Quoted Significant Significant Cash equivalents $ 11,800 $ 11,800 $ — $ — Corporate debt securities-short term 24,789 — 24,789 — Total $ 36,589 $ 11,800 $ 24,789 $ — |
ACCOUNTS PAYABLE AND ACCRUED EX
ACCOUNTS PAYABLE AND ACCRUED EXPENSES | 3 Months Ended |
Mar. 31, 2016 | |
Payables and Accruals [Abstract] | |
ACCOUNTS PAYABLE AND ACCRUED EXPENSES | 4. ACCOUNTS PAYABLE AND ACCRUED EXPENSES Accounts payable and accrued expenses include the following at March 31, 2016 and December 31, 2015: March 31, December 31, 2016 2015 Accounts payable $ 357 $ 186 Accrued payroll 914 1,956 Accrued outsourced pre-clinical and clinical fees 3,644 3,273 Accrued professional fees 247 516 Other accrued expenses 229 303 $ 5,391 $ 6,234 |
NET LOSS PER SHARE
NET LOSS PER SHARE | 3 Months Ended |
Mar. 31, 2016 | |
Earnings Per Share [Abstract] | |
NET LOSS PER SHARE | 5. NET LOSS PER SHARE Net loss per share is computed using the weighted average number of common shares outstanding. Basic and diluted net loss per share amounts are equivalent for the periods presented as the inclusion of potential common shares in the number of shares used for the diluted computation would be anti-dilutive to loss per share. Potential common shares, for the three months ended March 31, 2016, include 9,477,198 shares that would be issued upon the exercise of outstanding employee stock options and 3,567,956 shares that would be issued upon exercise of the stock options issued in our February 26, 2016 stock offering. Potential common shares, for the three months ended March 31, 2015, include 8,854,193 shares that would be issued upon the exercise of outstanding employee stock options. |
STOCK-BASED COMPENSATION AND ST
STOCK-BASED COMPENSATION AND STOCK PLANS | 3 Months Ended |
Mar. 31, 2016 | |
Compensation and Retirement Disclosure [Abstract] | |
STOCK-BASED COMPENSATION AND STOCK PLANS | 6. STOCK-BASED COMPENSATION AND STOCK PLANS Our stock-based compensation cost is measured at the grant date, based on the calculated fair value of the award, and is recognized as an expense over the employees’ requisite service period (generally the vesting period of the equity grant). We estimate the fair value of stock options using the Black-Scholes valuation model. Key input assumptions used to estimate the fair value of stock options include the exercise price of the award, expected option term, expected volatility of our stock over the option’s expected term, risk-free interest rate over the option’s expected term, and the expected annual dividend yield. We believe that the valuation technique and approach utilized to develop the underlying assumptions are appropriate in calculating the fair values of our stock options granted in the three months ended March 31, 2016 and 2015. The following table presents stock-based compensation expense included in our Condensed Statements of Operations and Comprehensive Loss: Three Months Ended 2016 2015 Research and development $ 190 $ 271 General and administrative 404 547 Total stock-based compensation expense $ 594 $ 818 In the three months ended March 31, 2016 and 2015, no stock-based compensation expense was capitalized and there were no recognized tax benefits associated with the stock-based compensation expense. Option activity under our stock plans for the three months ended March 31, 2016 was as follows: Stock Options Number of Weighted Outstanding as of December 31, 2015 8,305,950 $ 4.24 Granted 1,472,000 1.79 Exercised (97,498 ) 1.16 Cancelled (203,254 ) 3.95 Outstanding as of March 31, 2016 9,477,198 $ 3.89 Exercisable as of March 31, 2016 6,383,542 $ 4.93 The aggregate intrinsic value of options outstanding at March 31, 2016 was $472 and $102 related to exercisable options. The weighted average fair value of options granted in the three months ended March 31, 2016 and 2015 was $1.12 and $0.71 per share, respectively. The intrinsic value of options exercised in the three months ended March 31, 2016 was $60. Shares vested, expected to vest and exercisable at March 31, 2016 are as follows: Shares Weighted- Weighted- Aggregate Vested and unvested expected to vest at March 31, 2016 9,304,672 $ 3.89 5.7 $ 452 Exercisable at March 31, 2016 6,383,542 $ 4.93 4.1 $ 102 The total compensation cost not yet recognized as of March 31, 2016 related to non-vested option awards was $3.7 million, which will be recognized over a weighted-average period of 2.8 years. During the three months ended March 31, 2016, 126,036 shares expired and 2,218 shares were forfeited. The weighted average remaining contractual life for options exercisable at March 31, 2016 was 4.1 years. In 2013, we granted 242,697 shares of restricted stock to employees, vesting annually over a four year period. The weighted average fair value of the restricted stock at the time of grant in 2013 was $2.51 per share, and is being expensed ratably over the vesting period. Through March 31, 2016, 82,617 shares have been forfeited, and 130,804 shares have vested. We recognized share-based compensation expense related to restricted stock of $22 and $33 for the three months ended March 31, 2016 and 2015, respectively. Restricted stock activity under the Plan for the three months ended March 31, 2016 was as follows: Restricted Stock Number of Shares Weighted Average Unvested as of December 31, 2015 58,635 $ 2.51 Vested (29,306 ) 2.51 Cancelled (53 ) 2.51 Unvested as of March 31, 2016 29,276 $ 2.51 The fair value of restricted stock that vested in the three months ended March 31, 2016 and 2015 was $47 and $79, respectively. In July 2010, the Company amended its chief executive officer’s (the “CEO’s”) employment agreement to grant the CEO 100,000 stock options, of which 25% vested upon grant and 25% vested annually over the following three years, and a maximum of 390,000 performance-based stock units that vest upon the achievement of certain performance and market based targets. In March 2013, the Company amended its CEO’s employment agreement to modify the performance and market based targets. In February 2012, the Company amended its chief medical officer’s (the “CMO’s”) employment agreement to grant the CMO 50,000 performance-based stock units that vest upon the achievement of certain performance based targets. In March 2013, the Company amended its chief operating officer’s (the “COO’s”) employment agreement to grant the COO 125,000 performance-based stock units that vest upon the achievement of certain performance based targets. In March 2013, the Company amended its CMO’s employment agreement to grant the CMO 120,000 performance-based stock units that vest upon the achievement of certain performance based targets. Through March 31, 2016 no expense has been recorded for any performance-based stock units granted to the CEO, COO, or CMO. |
STOCK OFFERING
STOCK OFFERING | 3 Months Ended |
Mar. 31, 2016 | |
Stockholders' Equity Note [Abstract] | |
STOCK OFFERING | 7. STOCK OFFERING On February 26, 2016 the Company entered into definitive stock purchase agreements with certain institutional and accredited investors. In conjunction with this stock offering we issued 8,027,900 shares of our common stock and non-transferable options for 3,567,956 shares of our common stock for aggregate net proceeds of $15.2 million. Each option is exercisable for $2.50 per share and expires on March 22, 2017. If all options were to be exercised it would result in additional proceeds of approximately $8.9 million. |
RECENT ACCOUNTING PRONOUNCEMENT
RECENT ACCOUNTING PRONOUNCEMENTS | 3 Months Ended |
Mar. 31, 2016 | |
New Accounting Pronouncements and Changes in Accounting Principles [Abstract] | |
RECENT ACCOUNTING PRONOUNCEMENTS | 8. RECENT ACCOUNTING PRONOUNCEMENTS From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that are adopted by the Company as of the specified effective date. Unless otherwise discussed, we believe that the impact of recently issued standards that are not yet effective will not have a material impact on our financial position or results of operations upon adoption. In March 2016, the FASB issued ASU No. 2016-09, Compensation - Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting. The new standard involves several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities and classification on the statement of cash flows. The new standard will be effective for us on January 1, 2017. We are currently evaluating the potential impact that this standard may have on our financial position, results of operations and statement of cash flows. In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842). The new standard requires that all lessees recognize the assets and liabilities that arise from leases on the balance sheet and disclose qualitative and quantitative information about its leasing arrangements. The new standard will be effective for us on January 1, 2019. We are currently evaluating the potential impact that this standard may have on our financial position and results of operations. In August 2014, the FASB issued Accounting Standard Update (“ASU”) 2014-15, Presentation of Financial Statements—Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. Under the new guidance, management will be required to assess an entity’s ability to continue as a going concern, and to provide related footnote disclosures in certain circumstances. The provisions of this ASU are effective for annual periods ending after December 15, 2016, and for annual and interim periods thereafter. We are currently evaluating the potential impact that this ASU may have on our disclosures. In June 2014, the FASB issued ASU No. 2014-12, “Accounting for Share-Based Payments When the Terms of an Award Provide That a Performance Target Could Be Achieved after the Requisite Service Period.” This ASU requires a reporting entity to treat a performance target that affects vesting and that could be achieved after the requisite service period as a performance condition, and apply existing guidance under the Stock Compensation Topic of the ASC as it relates to awards with performance conditions that affect vesting to account for such awards. The provisions of this ASU are effective for interim and annual periods beginning after December 15, 2015. We evaluated this ASU and determined that it did not have a material impact on our financial position or results of operations. During the quarter ended June 30, 2014, the FASB issued ASU No. 2014-09, “Revenue from Contracts with Customers” (Topic 606), which supersedes all existing revenue recognition requirements, including most industry-specific guidance. The new standard requires a company to recognize revenue when it transfers goods or services to customers in an amount that reflects the consideration that the company expects to receive for those goods or services. In August 2015, the FASB issued ASU No. 2015-14, Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date, which delayed the effective date of the new standard from January 1, 2017 to January 1, 2018. The FASB also agreed to allow entities to choose to adopt the standard as of the original effective date. We are currently evaluating the method of adoption and the potential impact that Topic 606 may have on our financial position and results of operations. |
INCOME TAXES
INCOME TAXES | 3 Months Ended |
Mar. 31, 2016 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | 9. INCOME TAXES As of December 31, 2015, we had federal NOL, state NOL, and research and development credit carryforwards of approximately $357,122, $176,712 and $27,750 respectively, which expire at various dates through 2035. Approximately $15,020 of our federal NOL and $868 of our state NOL were generated from excess tax deductions from share-based awards, the tax benefit of which will be credited to additional paid-in-capital when the deductions reduce current taxes payable. At March 31, 2016 and December 31, 2015, we had no unrecognized tax benefits. We do not expect that the total amount of unrecognized tax benefits will significantly increase in the next twelve months. Our policy is to recognize interest and penalties related to uncertain tax positions in income tax expense. As of December 31, 2015 and 2014, we had no accrued interest or penalties related to uncertain tax positions. Our U.S. federal tax returns for the tax years 2012 through 2015 and our state tax returns for the tax years 2012 through 2015 remain open to examination. Prior tax years remain open to the extent of net operating loss and tax credit carryforwards. Utilization of NOL and research and development credit carryforwards may be subject to a substantial annual limitation in the event of an ownership change that has occurred previously or could occur in the future pursuant to Section 382 and 383 of the Internal Revenue Code of 1986, as amended, as well as similar state provisions. An ownership change may limit the amount of NOL and research and development credit carryforwards that can be utilized annually to offset future taxable income, and may, in turn, result in the expiration of a portion of those carryforwards before utilization. In general, an ownership change, as defined by Section 382, results from transactions that increase the ownership of certain stockholders or public groups in the stock of a corporation by more than 50 percentage points over a three year period. We undertook a detailed study of our NOL and research and development credit carryforwards through January 31, 2016, to determine whether such amounts are likely to be limited by Sections 382 or 383. As a result of this analysis, we currently do not believe any Sections 382 or 383 limitations will significantly impact our ability to offset income with available NOL and research and development credit carryforwards. However, future ownership changes under Section 382 may limit our ability to fully utilize these tax benefits. |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2016 | |
Accounting Policies [Abstract] | |
BASIS OF PRESENTATION | We have prepared the accompanying condensed financial statements pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been condensed or omitted pursuant to these rules and regulations. These condensed financial statements should be read in conjunction with our audited financial statements and footnotes related thereto for the year ended December 31, 2015 included in our annual report on Form 10-K filed with the SEC on February 29, 2016. In the opinion of the Company, the accompanying unaudited condensed financial statements contain all adjustments, consisting only of normal recurring adjustments, necessary for a fair statement of its financial position as of March 31, 2016, and its results of operations and cash flows for the three months ended March 31, 2016 and March 31, 2015. The results of operations for such interim periods are not necessarily indicative of the results to be achieved for the full year. The condensed balance sheet at December 31, 2015, was derived from audited annual financial statements, but does not contain all of the footnote disclosures from the annual financial statements. |
MARKETABLE SECURITIES AND FAI16
MARKETABLE SECURITIES AND FAIR VALUE MEASUREMENTS (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Marketable Securities and Fair Value Measurements [Abstract] | |
Schedule of fair value of available-for-sale marketable securities | March 31, 2016 Amortized Gross Gross Fair Security type Corporate debt securities-short term $ 27,648 $ 33 $ (1 ) $ 27,680 Total available-for-sale marketable securities $ 27,648 $ 33 $ (1 ) $ 27,680 December 31, 2015 Amortized Gross Gross Fair Security type Corporate debt securities-short term $ 24,786 $ 13 $ (10 ) $ 24,789 Total available-for-sale marketable securities $ 24,786 $ 13 $ (10 ) $ 24,789 |
Schedule of assets measured at fair value on a recurring basis | March 31, Quoted Significant Significant Cash equivalents $ 15,976 $ 15,976 $ — $ — Corporate debt securities-short term 27,680 — 27,680 — Total $ 43,656 $ 15,976 $ 27,680 $ — December 31, Quoted Significant Significant Cash equivalents $ 11,800 $ 11,800 $ — $ — Corporate debt securities-short term 24,789 — 24,789 — Total $ 36,589 $ 11,800 $ 24,789 $ — |
ACCOUNTS PAYABLE AND ACCRUED 17
ACCOUNTS PAYABLE AND ACCRUED EXPENSES (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Payables and Accruals [Abstract] | |
Schedule of accounts payable and accrued expense | March 31, December 31, 2016 2015 Accounts payable $ 357 $ 186 Accrued payroll 914 1,956 Accrued outsourced pre-clinical and clinical fees 3,644 3,273 Accrued professional fees 247 516 Other accrued expenses 229 303 $ 5,391 $ 6,234 |
STOCK-BASED COMPENSATION AND 18
STOCK-BASED COMPENSATION AND STOCK PLANS (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Compensation and Retirement Disclosure [Abstract] | |
Schedule of stock-based compensation expense | Three Months Ended 2016 2015 Research and development $ 190 $ 271 General and administrative 404 547 Total stock-based compensation expense $ 594 $ 818 |
Schedule of activity of options under stock plans | Stock Options Number of Weighted Outstanding as of December 31, 2015 8,305,950 $ 4.24 Granted 1,472,000 1.79 Exercised (97,498 ) 1.16 Cancelled (203,254 ) 3.95 Outstanding as of March 31, 2016 9,477,198 $ 3.89 Exercisable as of March 31, 2016 6,383,542 $ 4.93 |
Schedule of shares vested, expected to vest and exercisable | Shares Weighted- Weighted- Aggregate Vested and unvested expected to vest at March 31, 2016 9,304,672 $ 3.89 5.7 $ 452 Exercisable at March 31, 2016 6,383,542 $ 4.93 4.1 $ 102 |
Schedule of restricted stock activity | Restricted Stock Number of Shares Weighted Average Unvested as of December 31, 2015 58,635 $ 2.51 Vested (29,306 ) 2.51 Cancelled (53 ) 2.51 Unvested as of March 31, 2016 29,276 $ 2.51 |
NATURE OF OPERATIONS AND BASI19
NATURE OF OPERATIONS AND BASIS OF PRESENTATION (Detail Textuals) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Net use of cash | $ (6,432) | $ (7,554) |
License agreement | Daiichi Sankyo Co. Ltd | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Milestone payment received | 100,000 | |
Milestone payments related to first patient enrolled in METIV-HCC trial | 15,000 | |
License agreement | Kyowa Hakko Kirin Co. Ltd. | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Milestone payment received | $ 48,000 |
COLLABORATIONS AND ALLIANCES (D
COLLABORATIONS AND ALLIANCES (Detail Textuals) - USD ($) $ in Thousands | Nov. 03, 2015 | Jan. 31, 2013 | Feb. 28, 2011 | Dec. 31, 2008 | Mar. 31, 2016 | Mar. 31, 2015 |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Baseline Contractual Rate | 20.00% | |||||
Notice period for termination of contract prior to start of specified period | 90 days | |||||
Notice period for termination of contract post start of Phase 3 clinical trials | 180 days | |||||
Net revenues | $ 1,227 | $ 2,785 | ||||
Phase 3 collaboration costs | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Total milestone partially offset | $ 155,000 | |||||
Cumulative share of phase 3 collaboration costs in excess of milestones amounts received | 63,300 | |||||
Cumulative share of phase 3 collaboration costs | 103,300 | |||||
Milestone payment received | $ 15,000 | $ 25,000 | ||||
Non-Phase 3 tivantinib collaboration costs | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Cumulative share of phase 3 collaboration costs in excess of milestones amounts received | 79 | 10 | ||||
Daiichi Sankyo Tivantinib Agreement | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Upfront payment received | $ 60,000 | |||||
Additional potential development and sales milestone payments | $ 560,000 | |||||
Milestone payments for official acceptance of drug approval applications | 55,000 | |||||
Milestone payments to be received upon regulatory approvals and first commercial sales | $ 100,000 | |||||
Net revenues | 700 | $ 1,400 | ||||
Deferred revenue | $ 2,100 |
COLLABORATIONS AND ALLIANCES 21
COLLABORATIONS AND ALLIANCES (Detail Textuals 1) - USD ($) $ in Thousands | May. 07, 2007 | Aug. 31, 2011 | Sep. 30, 2010 | Feb. 29, 2008 | Apr. 27, 2007 | Mar. 31, 2016 | Mar. 31, 2015 |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Research and development revenue | $ 1,227 | $ 2,785 | |||||
Kyowa Hakko Kirin Licensing Agreement | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Upfront payment received | $ 27,000 | $ 3,000 | |||||
Upfront and potential development milestone payments | 123,000 | ||||||
Cash upfront licensing payments | $ 30,000 | ||||||
Notice period for termination of contract | 90 days | ||||||
Research and development revenue | $ 500 | $ 1,400 | |||||
Deferred revenue | $ 1,400 | ||||||
Kyowa Hakko Kirin Licensing Agreement | Phase Two trial Kyowa Hakko Kirin | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Milestone payment received | $ 5,000 | ||||||
Kyowa Hakko Kirin Licensing Agreement | Phase Three Attention Trial Asia | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Milestone payment received | $ 10,000 | ||||||
Kyowa Hakko Kirin Licensing Agreement | Kyowa Hakko Kirin | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Milestone payment received | $ 3,000 | ||||||
Percentage of royalties expected to be received - lower range | mid-teen percent | ||||||
Percentage of royalties expected to be received - upper range | low-twenty percent |
MARKETABLE SECURITIES AND FAI22
MARKETABLE SECURITIES AND FAIR VALUE MEASUREMENTS - Summary of fair value of available-for-sale securities (Details) - USD ($) $ in Thousands | Mar. 31, 2016 | Dec. 31, 2015 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 27,648 | $ 24,786 |
Gross Unrealized Gains | 33 | 13 |
Gross Unrealized Losses | (1) | (10) |
Fair Value | 27,680 | 24,789 |
Corporate debt securities | Short term | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 27,648 | 24,786 |
Gross Unrealized Gains | 33 | 13 |
Gross Unrealized Losses | (1) | (10) |
Fair Value | $ 27,680 | $ 24,789 |
MARKETABLE SECURITIES AND FAI23
MARKETABLE SECURITIES AND FAIR VALUE MEASUREMENTS - Assets measured at fair value on a recurring basis (Details 1) - USD ($) $ in Thousands | Mar. 31, 2016 | Dec. 31, 2015 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Corporate debt securities-short term | $ 27,680 | $ 24,789 |
Fair Value, Measurements, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 15,976 | 11,800 |
Total | 43,656 | 36,589 |
Fair Value, Measurements, Recurring | Corporate debt securities | Short term | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Corporate debt securities-short term | 27,680 | 24,789 |
Fair Value, Measurements, Recurring | Quoted Prices in Active Markets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 15,976 | 11,800 |
Total | $ 15,976 | $ 11,800 |
Fair Value, Measurements, Recurring | Quoted Prices in Active Markets (Level 1) | Corporate debt securities | Short term | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Corporate debt securities-short term | ||
Fair Value, Measurements, Recurring | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | ||
Total | $ 27,680 | $ 24,789 |
Fair Value, Measurements, Recurring | Significant Other Observable Inputs (Level 2) | Corporate debt securities | Short term | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Corporate debt securities-short term | $ 27,680 | $ 24,789 |
Fair Value, Measurements, Recurring | Significant Unobservable Inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | ||
Total | ||
Fair Value, Measurements, Recurring | Significant Unobservable Inputs (Level 3) | Corporate debt securities | Short term | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Corporate debt securities-short term |
ACCOUNTS PAYABLE AND ACCRUED 24
ACCOUNTS PAYABLE AND ACCRUED EXPENSES - Summary of accounts payable and accrued expenses (Details) - USD ($) $ in Thousands | Mar. 31, 2016 | Dec. 31, 2015 |
Payables and Accruals [Abstract] | ||
Accounts payable | $ 357 | $ 186 |
Accrued payroll | 914 | 1,956 |
Accrued outsourced pre-clinical and clinical fees | 3,644 | 3,273 |
Accrued professional fees | 247 | 516 |
Other accrued expenses | 229 | 303 |
Accounts payable and accrued expenses, Total | $ 5,391 | $ 6,234 |
NET LOSS PER SHARE (Detail Text
NET LOSS PER SHARE (Detail Textuals) - shares | 1 Months Ended | 3 Months Ended | |
Feb. 26, 2016 | Mar. 31, 2016 | Mar. 31, 2015 | |
Earnings Per Share [Abstract] | |||
Potential common shares issued upon exercise of outstanding stock options | 3,567,956 | 9,477,198 | 8,854,193 |
STOCK-BASED COMPENSATION AND 26
STOCK-BASED COMPENSATION AND STOCK PLANS - Stock-based compensation expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Total stock-based compensation expense | $ 594 | $ 818 |
Research and development | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Total stock-based compensation expense | 190 | 271 |
General and administrative | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Total stock-based compensation expense | $ 404 | $ 547 |
STOCK-BASED COMPENSATION AND 27
STOCK-BASED COMPENSATION AND STOCK PLANS - Option activity (Details 1) - Stock Options | 3 Months Ended |
Mar. 31, 2016$ / sharesshares | |
Number of Shares | |
Outstanding as of December 31, 2015 | shares | 8,305,950 |
Granted | shares | 1,472,000 |
Exercised | shares | (97,498) |
Cancelled | shares | (203,254) |
Outstanding as of March 31, 2016 | shares | 9,477,198 |
Exercisable as of March 31, 2016 | shares | 6,383,542 |
Weighted Average Exercise Price | |
Outstanding as of December 31, 2014 | $ / shares | $ 4.24 |
Granted | $ / shares | 1.79 |
Exercised | $ / shares | 1.16 |
Cancelled | $ / shares | 3.95 |
Outstanding as of March 31, 2016 | $ / shares | 3.89 |
Exercisable as of March 31, 2016 | $ / shares | $ 4.93 |
STOCK-BASED COMPENSATION AND 28
STOCK-BASED COMPENSATION AND STOCK PLANS - Shares vested, expected to vest and exercisable (Details 2) - Stock Options $ / shares in Units, $ in Thousands | 3 Months Ended |
Mar. 31, 2016USD ($)$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Vested and unvested expected to vest shares | shares | 9,304,672 |
Vested and unvested expected to vest, weighted-average exercise price | $ / shares | $ 3.89 |
Vested and unvested expected to vest, weighted-average remaining contractual term (in years) | 5 years 8 months 12 days |
Vested and unvested expected to vest, aggregate intrinsic value | $ | $ 452 |
Exercisable shares | shares | 6,383,542 |
Exercisable, weighted-average exercise price | $ / shares | $ 4.93 |
Exercisable, weighted-average remaining contractual term (in years) | 4 years 1 month 6 days |
Exercisable, aggregate intrinsic value | $ | $ 102 |
STOCK-BASED COMPENSATION AND 29
STOCK-BASED COMPENSATION AND STOCK PLANS - Restricted stock activity (Details 3) - Restricted Stock | 3 Months Ended |
Mar. 31, 2016$ / sharesshares | |
Number of Shares | |
Unvested as of December 31, 2015 | shares | 58,635 |
Vested | shares | (29,306) |
Cancelled | shares | (53) |
Unvested as of March 31, 2016 | shares | 29,276 |
Weighted Average Grant Date Fair Value | |
Unvested as of December 31, 2015 | $ / shares | $ 2.51 |
Vested | $ / shares | 2.51 |
Cancelled | $ / shares | 2.51 |
Unvested as of March 31, 2016 | $ / shares | $ 2.51 |
STOCK-BASED COMPENSATION AND 30
STOCK-BASED COMPENSATION AND STOCK PLANS (Detail Textuals) - Stock Options - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Aggregate intrinsic value of options outstanding | $ 472 | |
Aggregate intrinsic value of options exercisable | $ 102 | |
Weighted average grant date fair value of options granted (in dollars per share) | $ 1.12 | $ 0.71 |
Intrinsic value of options exercised | $ 60 | |
Employee Service Share-Based Compensation, Nonvested Awards, Total Compensation Cost Not Yet Recognized, Stock Options | $ 3,700 | |
Compensation cost related to non-vested option awards recognition period | 2 years 9 months 18 days | |
Number of the non-vested options shares expired during the period | 126,036 | |
Number of options forfeited during the period | 2,218 | |
Weighted average remaining contractual life for options exercisable | 4 years 1 month 6 days |
STOCK-BASED COMPENSATION AND 31
STOCK-BASED COMPENSATION AND STOCK PLANS (Detail Textuals 1) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | 39 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | Dec. 31, 2013 | Mar. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation expense | $ 594 | $ 818 | ||
Restricted Stock | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of shares granted | 242,697 | |||
Award vesting period | 4 years | |||
Weighted average grant date fair value for the options granted during the period (in dollars per share) | $ 2.51 | |||
Number of shares forfeited | 82,617 | |||
Number of shares vested during the period | 130,804 | |||
Share-based compensation expense | 22 | 33 | ||
Fair value of stock vested during period | $ 47 | $ 79 |
STOCK-BASED COMPENSATION AND 32
STOCK-BASED COMPENSATION AND STOCK PLANS (Detail Textuals 2) - shares | 1 Months Ended | 3 Months Ended | ||
Mar. 31, 2013 | Feb. 29, 2012 | Jul. 31, 2010 | Mar. 31, 2016 | |
Stock Options | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Granted | 1,472,000 | |||
Chief executive officer employment agreement | Chief executive officer (CEO) | Stock Options | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Granted | 100,000 | |||
Chief executive officer employment agreement | Chief executive officer (CEO) | Stock Options | Vested upon grant | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Percentage of options vested | 25.00% | |||
Chief executive officer employment agreement | Chief executive officer (CEO) | Stock Options | Vest annually | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Percentage of options vested | 25.00% | |||
Award vesting period | 3 years | |||
Chief executive officer employment agreement | Chief executive officer (CEO) | Performance-based stock units | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of stocks vested during the period | 390,000 | |||
Chief medical officer employment agreement | Chief medical officer (CMO) | Performance-based stock units | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of stocks vested during the period | 120,000 | 50,000 | ||
Chief operating officer employment agreement | Chief operating officer (COO) | Performance-based stock units | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of stocks vested during the period | 125,000 |
STOCK OFFERING (Detail Textuals
STOCK OFFERING (Detail Textuals) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended |
Feb. 26, 2016 | Mar. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Additional proceeds if optios exercised | $ 114 | |
Definitive stock purchase agreements | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of common stock issued under agreement | 8,027,900 | |
Number of non transferable options issued | 3,567,956 | |
Aggregate net proceeds | $ 15,200 | |
Stock option exercise price | $ 2.50 | |
Additional proceeds if optios exercised | $ 8,900 |
INCOME TAXES (Detail Textuals)
INCOME TAXES (Detail Textuals) $ in Thousands | 3 Months Ended |
Mar. 31, 2016USD ($) | |
Operating Loss Carryforwards [Line Items] | |
Increase in ownership percentage of certain stockholders or public groups | more than 50 percentage points |
Ownership change, increase in ownership percentage, term | 3 years |
Federal income tax | |
Operating Loss Carryforwards [Line Items] | |
Net operating loss | $ 357,122 |
Net operating loss generated from excess tax deduction from share based awards | 15,020 |
State income tax | |
Operating Loss Carryforwards [Line Items] | |
Net operating loss | 176,712 |
Net operating loss generated from excess tax deduction from share based awards | 868 |
Research and development credit carryforwards | |
Operating Loss Carryforwards [Line Items] | |
Net operating loss | $ 27,750 |