Document_and_Entity_Informatio
Document and Entity Information | 9 Months Ended | |
Sep. 30, 2014 | Oct. 27, 2014 | |
Document and Entity Information [Abstract] | ' | ' |
Entity Registrant Name | 'ARQULE INC | ' |
Entity Central Index Key | '0001019695 | ' |
Trading Symbol | 'arql | ' |
Current Fiscal Year End Date | '--12-31 | ' |
Entity Filer Category | 'Accelerated Filer | ' |
Entity Common Stock, Shares Outstanding | ' | 62,770,092 |
Document Type | '10-Q | ' |
Document Period End Date | 30-Sep-14 | ' |
Amendment Flag | 'false | ' |
Document Fiscal Year Focus | '2014 | ' |
Document Fiscal Period Focus | 'Q3 | ' |
CONDENSED_BALANCE_SHEETS_Unaud
CONDENSED BALANCE SHEETS (Unaudited) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Current assets: | ' | ' |
Cash and cash equivalents | $16,099 | $15,579 |
Marketable securities-short term | 45,989 | 59,116 |
Prepaid expenses and other current assets | 1,305 | 941 |
Total current assets | 63,393 | 75,636 |
Marketable securities-long term | 7,228 | 20,391 |
Property and equipment, net | 316 | 1,128 |
Other assets | 102 | 1,024 |
Total assets | 71,039 | 98,179 |
Current liabilities: | ' | ' |
Accounts payable and accrued expenses | 7,195 | 8,470 |
Note payable | 1,700 | 1,700 |
Current portion of deferred revenue | 11,056 | 11,031 |
Current portion of deferred gain on sale leaseback | 368 | 552 |
Total current liabilities | 20,319 | 21,753 |
Deferred revenue, net of current portion | 7,315 | 15,568 |
Deferred gain on sale leaseback, net of current portion | ' | 232 |
Total liabilities | 27,634 | 37,553 |
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; 62,770,092 and 62,736,207 shares issued and outstanding at September 30, 2014 and December 31, 2013, respectively | 628 | 627 |
Additional paid-in capital | 507,583 | 504,884 |
Accumulated other comprehensive income | 25 | 67 |
Accumulated deficit | -464,831 | -444,952 |
Total stockholders' equity | 43,405 | 60,626 |
Total liabilities and stockholders' equity | $71,039 | $98,179 |
CONDENSED_BALANCE_SHEETS_Unaud1
CONDENSED BALANCE SHEETS (Unaudited) (Parentheticals) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
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 | ' | ' |
Preferred stock, shares outstanding | ' | ' |
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 | 62,770,092 | 62,736,207 |
Common stock, shares outstanding | 62,770,092 | 62,736,207 |
CONDENSED_STATEMENTS_OF_OPERAT
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited) (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, except Per Share data, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 |
Income Statement [Abstract] | ' | ' | ' | ' |
Research and development revenue | $2,662 | $3,542 | $8,239 | $13,639 |
Costs and expenses: | ' | ' | ' | ' |
Research and development | 5,014 | 5,955 | 17,981 | 22,218 |
General and administrative | 2,997 | 3,113 | 9,318 | 9,711 |
Restructuring and other costs | 1,099 | 667 | 1,099 | 667 |
Total costs and expenses | 9,110 | 9,735 | 28,398 | 32,596 |
Loss from operations | -6,448 | -6,193 | -20,159 | -18,957 |
Interest income | 62 | 114 | 233 | 397 |
Interest expense | -11 | -8 | -28 | -18 |
Other income (expense) | -2 | 4 | 75 | -66 |
Net loss | -6,399 | -6,083 | -19,879 | -18,644 |
Unrealized gain (loss) on marketable securities | -21 | 41 | -42 | -17 |
Comprehensive loss | ($6,420) | ($6,042) | ($19,921) | ($18,661) |
Basic and diluted net loss per share: | ' | ' | ' | ' |
Net loss per share (in dollars per share) | ($0.10) | ($0.10) | ($0.32) | ($0.30) |
Weighted average basic and diluted common shares outstanding (in shares) | 62,652 | 62,512 | 62,621 | 62,457 |
CONDENSED_STATEMENTS_OF_CASH_F
CONDENSED STATEMENTS OF CASH FLOWS (Unaudited) (USD $) | 9 Months Ended | |
In Thousands, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2013 |
Cash flows from operating activities: | ' | ' |
Net loss | ($19,879) | ($18,644) |
Adjustments to reconcile net loss to net cash used in operating activities: | ' | ' |
Depreciation and amortization | 532 | 658 |
Amortization of premium on marketable securities | 893 | 1,682 |
Amortization of deferred gain on sale leaseback | -416 | -416 |
Non-cash stock compensation | 2,643 | 3,201 |
Loss (gain) on auction rate securities | -75 | 66 |
Impairment of property and equipment | 280 | ' |
Changes in operating assets and liabilities: | ' | ' |
Prepaid expenses and other assets | 558 | 142 |
Accounts payable and accrued expenses | -1,275 | -2,073 |
Deferred revenue | -8,228 | -10,609 |
Net cash used in operating activities | -24,967 | -25,993 |
Cash flows from investing activities: | ' | ' |
Purchases of marketable securities | -27,504 | -29,275 |
Proceeds from sale or maturity of marketable securities | 52,934 | 57,777 |
Net cash provided by investing activities | 25,430 | 28,502 |
Cash flows from financing activities: | ' | ' |
Proceeds from stock option exercises and employee stock plan purchases | 57 | 213 |
Net cash provided by financing activities | 57 | 213 |
Net increase in cash and cash equivalents | 520 | 2,722 |
Cash and cash equivalents, beginning of period | 15,579 | 14,327 |
Cash and cash equivalents, end of period | $16,099 | $17,049 |
NATURE_OF_OPERATIONS_AND_BASIS
NATURE OF OPERATIONS AND BASIS OF PRESENTATION | 9 Months Ended | |
Sep. 30, 2014 | ||
Organization and Nature Of Operations [Abstract] | ' | |
NATURE OF OPERATIONS AND BASIS OF PRESENTATION | ' | |
1 | NATURE OF OPERATIONS AND BASIS OF PRESENTATION | |
We are a clinical-stage biotechnology company organized as a Delaware corporation in 1993 engaged in the research and development of innovative cancer therapeutics. Our mission is to produce novel drugs with differentiated mechanisms of action that will extend the lives of our patients. These drugs target biological pathways implicated in a wide range of cancers. In addition to our clinical stage pipeline, our drug discovery efforts focus on a number of pre-clinical programs derived from our kinase platform technology and extensive library of proprietary compounds that have the potential to fulfill this mission. | ||
Our lead product candidate is tivantinib (ARQ 197), an orally administered, small molecule inhibitor of the c-Met receptor tyrosine kinase (“c-MET”) and its biological pathway. C-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 designed to realize the broad potential of 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”). We have also completed earlier-stage combination therapy trials and pre-clinical experiments with tivantinib and other anti-cancer agents that may provide data to support later-stage trials in additional indications. | ||
Our most advanced ongoing clinical trial, the METIV-HCC trial, is a pivotal Phase 3 randomized, double-blind, controlled study of tivantinib as single agent therapy in previously treated patients with MET diagnostic-high, inoperable HCC conducted by Daiichi Sankyo and us. A dose reduction in the METIV-HCC trial from 240 mg twice daily (“BID”) tablets to 120 mg BID tablets was implemented in September 2013 following the observation of a higher incidence of neutropenia in the initial phase of the METIV-HCC trial than was observed in the Phase 2 trial in the same patient population, which employed a 240 mg BID capsule dose, and in other trials with tivantinib. Certain enhanced patient monitoring procedures were temporarily instituted to confirm the safety profile of the lower dose. Following a review of data analyses from a predefined number of patients who received this lower dose, the Data Monitoring Committee (“DMC”) of the METIV-HCC trial recommended in January 2014 continuation of the ongoing trial, with patients receiving the lower dose. | ||
Approximately 300 patients are planned to be enrolled in the METIV-HCC trial at approximately 120 clinical sites worldwide. Our current estimate of the time frame to completion of patient accrual is the end of 2015. We define patient accrual as the process of screening and identifying patients for subsequent randomization into the treatment arms of the trial. This trial is being conducted under a Special Protocol Assessment (“SPA”) agreement with the FDA. An SPA is an agreement establishing the design, endpoints and statistical analysis of a clinical trial intended to provide the necessary data, depending on the outcome of the trial, which could support the filing of a New Drug Application (“NDA”). Final marketing approval depends on the results of the trial. Because the METIV-HCC trial is enrolling patients with MET-diagnostic high HCC whom we believe are likely to benefit from treatment with tivantinib, the SPA also includes an immunohistochemistry (“IHC”)-based companion diagnostic (“CDx”) under development by a third party provider of such tests in collaboration with Daiichi Sankyo and ourselves. This CDx is being developed to enable the identification of the MET status of patients seeking to be enrolled in the trial. Our collaborator for this companion diagnostic test and our collaborator for a second test will each need to submit a Premarket Approval (“PMA”) application to FDA that establishes the predictive value of the respective CDx in connection with the registration and commercialization of the drug in the U.S., and additional regulatory applications will need to be made in other geographic areas. | ||
In addition to METIV-HCC, a second Phase 3 clinical trial in HCC with tivantinib, the JET-HCC trial, is ongoing in Japan. On February 4, 2014, Kyowa Hakko Kirin, our partner for the development of tivantinib in Asian territories, announced the initiation of this trial in Japanese patients with MET diagnostic-high, inoperable HCC treated with one prior therapy with sorafenib. The trial is a randomized, double-blind placebo-controlled study to compare progression free survival (“PFS”) in patients treated with tivantinib with those treated with placebo. Kyowa Hakko Kirin plans to enroll approximately 160 patients in this study. There were no milestone payments associated with the initiation of this trial. | ||
On January 16, 2014, we reported that Kyowa Hakko Kirin provided us with top-line results of the amended Phase 3 randomized, double-blind ATTENTION clinical trial evaluating the combination of tivantinib and erlotinib in second-line patients with advanced or metastatic non-squamous non-small cell lung cancer (“NSCLC”) with wild-type epidermal growth factor receptor (“EGFR”) in Asia (Japan, Korea and Taiwan). Enrollment in ATTENTION had been originally planned at 460 patients. Recruitment of new patients was permanently suspended in October 2012 based on a recommendation by the trial’s Safety Review Committee following an observed imbalance in interstitial lung disease (“ILD”) cases as a drug-related adverse event. Patients recruited into ATTENTION as of October 2012 were allowed to continue thereafter in the trial after being re-consented, and including such patients, 307 patients in total were included in the final analysis. | ||
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. During 2011, we received $25 million from Daiichi Sankyo resulting from the dosing of the first patient in the MARQUEE trial and $10 million from Kyowa Hakko Kirin resulting from dosing of the first patient in the ATTENTION trial. 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 from Daiichi Sankyo. 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. The terms of our tivantinib licensing agreements with Daiichi Sankyo and Kyowa Hakko Kirin remain in effect following the recent developments in both of these trials. | ||
We are collaborating with the National Cancer Institute (“NCI”) through its Cancer Therapy Evaluation Program (“CTEP”) to explore the clinical potential of tivantinib in a variety of tumor indications while we focus our internal efforts on the two Phase 3 programs in HCC. These CTEP-sponsored trials include Phase 2 single agent trials in prostate cancer (randomized), multiple myeloma, breast cancer and malignant mesothelioma, and Phase 2 combination therapy trials in kidney cancer (with or without erlotinib, randomized) and head and neck cancer (with or without cetuximab, randomized). | ||
The NCI has reported to us that the randomized, double blind, placebo-controlled CTEP Phase 2 clinical trial of tivantinib as a single agent in prostate cancer met its primary endpoint of progression-free survival (“PFS”). Additional data from this trial is expected to be presented at a future scientific forum. As final data emerge from this trial, we and our partner, Daiichi Sankyo, will discuss with the NIH the potential for additional trials in this indication. In addition, in the uncontrolled single agent, signal generation CTEP studies in breast cancer and multiple myeloma, the primary endpoint of response rate was not met. As a result, we do not plan to prioritize development in these indications at this time. | ||
Our proprietary pipeline of product candidates is directed toward molecular targets and biological processes with demonstrated roles in the development of human cancers. Our priorities within this pipeline include ARQ 092, an Akt inhibitor, and ARQ 087, an inhibitor of fibroblast growth factor receptor. Both of these compounds have completed Phase 1a clinical testing and are advancing into Phase 1b testing in cohorts of patients enriched with specific types of tumors that we believe may benefit from treatment with ARQ 092 and ARQ 087 respectively and in combination with each other and other anti-cancer agents. In addition, we have entered into an agreement with the National Human Genome Research Institute of the NIH for a clinical trial investigating ARQ 092 as a potential treatment for Proteus Syndrome, a rare overgrowth disorder caused by a mutation in the Akt 1 gene. We are also supporting an ongoing investigator-sponsored trial with ARQ 761, which is being investigated as a potential NQ01 inhibitor. | ||
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, 2013 included in our annual report on Form 10-K filed with the SEC on March 5, 2014. | ||
The unaudited condensed financial statements include, in our opinion, all adjustments (consisting only of normal recurring adjustments) necessary for a fair statement of our financial position as of September 30, 2014, the results of our operations for the three and nine months ended September 30, 2014 and 2013, and cash flows for the nine months ended September 30, 2014 and 2013. The results of operations for such interim periods are not necessarily indicative of the results to be achieved for the full year. |
COLLABORATIONS_AND_ALLIANCES
COLLABORATIONS AND ALLIANCES | 9 Months Ended | |
Sep. 30, 2014 | ||
Organization, Consolidation and Presentation Of Financial Statements [Abstract] | ' | |
COLLABORATIONS AND ALLIANCES | ' | |
2 | COLLABORATIONS AND ALLIANCES | |
Daiichi Sankyo ARQ 092 Agreement | ||
We have regained worldwide rights for the development and commercialization of ARQ 092 and all other compounds included under our Akt collaboration with Daiichi Sankyo pursuant to their formal notice to terminate our license and commercialization agreement received on March 26, 2013. Termination of this agreement was effective 90 days from our receipt of the formal notice from Daiichi Sankyo, following which we became responsible for funding the remainder of the ongoing Phase 1 trial with ARQ 092 beyond the contractual termination period, as well as any future clinical development and commercialization of this compound. The license agreement had provided exclusive rights to Daiichi Sankyo for the development, manufacturing and marketing of ARQ 092 on a worldwide basis. Under this agreement, we received a $10 million upfront fee from Daiichi Sankyo in November 2011. Following the termination of this agreement, ARQ 092 has become our proprietary asset, and Daiichi Sankyo has no further financial or other obligations or rights related to this program. | ||
On November 10, 2011, we and Daiichi Sankyo announced the execution of a license agreement for the development of ARQ 092. The license agreement provided exclusive rights to Daiichi Sankyo for the development, manufacturing and marketing of ARQ 092 on a worldwide basis. Revenue for this agreement was recognized using Financial Accounting Standards Board Accounting Standards Update No. 2009-13, Multiple-Deliverable Revenue Arrangements (“ASU 2009-13”). Under ASU 2009-13 all undelivered items under an agreement are divided into separate units of accounting based on whether the deliverable provides stand-alone value to the licensee. The Company determined the best estimate selling price (BESP) for each unit of accounting based upon management’s judgment and including factors such as discounted cash flows, estimated direct expenses and other costs and probability of successful outcome of clinical trials. | ||
As the license granted under the agreement was delivered, the license had standalone value, and there were no further obligations related to the license, revenue of $10 million related to this accounting unit was recognized in 2011 based on the best estimate of selling price of the license. Revenue related to clinical trial costs and steering committee services were recognized ratably over the clinical trial as services were provided and costs were incurred, up to the amount of cash received for these deliverables based on the best estimate of selling price of each deliverable. The development period for this agreement concluded in June 2013 and accordingly we recognized no revenue for the three or nine months ended September 30, 2014. We recognized revenue of zero and $1.3 million, related to this agreement for the three and nine months ended September 30, 2013. At September 30, 2014, there was no remaining deferred revenue related to this agreement. | ||
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 terms of our tivantinib agreement with Daiichi Sankyo remain in effect following the recent developments in the trials described in Note 1. | ||
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 the Phase 3 costs. Upon commercialization, we will receive tiered, double-digit royalties from Daiichi Sankyo on net sales of tivantinib commensurate with the magnitude of the transaction. We retain the option to participate in the commercialization of tivantinib in the U.S. 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 September 30, 2014, totaled $87.8 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 September 30, 2014 by $47.8 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 September 30, 2014 our non-Phase 3 tivantinib collaboration costs incurred were less than those of Daiichi Sankyo’s by $102 which was recognized as contra-revenue and netted against our tivantinib Daiichi Sankyo research and development revenue. For the nine months ended September 30, 2014, no research and development revenue was recognized related to our non-Phase 3 tivantinib collaboration as our costs incurred were offset by an equal amount of contra-revenue. | ||
For the quarter ended September 30, 2013, our non-Phase 3 tivantinib collaboration costs incurred exceeded those of Daiichi Sankyo’s, and we recognized $23 as research and development revenue under the contingency adjusted performance model. Through the nine months ended September 30, 2013, we recognized a net of $0.1 million of research and development revenue related to our non-Phase 3 tivantinib collaboration costs which included contra-revenue of $0.2 million and $0.3 million of 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 the Data Monitoring Committee 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. For the three and nine months ended September 30, 2014 and 2013, $1.2 million and $4.0 million, and $2.1 million and $6.3 million, respectively, were recognized as net revenue. At September 30, 2014, $9.4 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. The terms of our tivantinib licensing agreement with Kyowa Hakko Kirin remain in effect following the recent 2013 developments in the Phase 3 ATTENTION trial in Asia described above. | ||
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 with an estimated development period through April 2016. | ||
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 September 30, 2014, 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. | ||
Revenue for this agreement is recognized using the contingency-adjusted performance model with an estimated development period through April 2016. For the three and nine months ended September 30, 2014 and 2013, $1.4 million and $4.3 million, and $1.4 million and $4.3 million, respectively were recognized as revenue. At September 30, 2014, $9.0 million remains in deferred revenue. | ||
Other Project Revenue | ||
During the nine months ended September 30, 2013, we completed a one-time research project. In connection with this project we received a payment of $1.8 million which we recognized as revenue in the nine months ended September 30, 2013. |
MARKETABLE_SECURITIES_AND_FAIR
MARKETABLE SECURITIES AND FAIR VALUE MEASUREMENTS | 9 Months Ended | |||||||||||||||||
Sep. 30, 2014 | ||||||||||||||||||
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. Our auction rate securities are classified as trading securities and any changes in the fair value of those securities are recorded as 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. | ||||||||||||||||||
We invest our available cash primarily in U.S. Treasury bill funds, money market funds, commercial paper, and U.S. federal and state agency backed certificates, including auction rate securities that have investment grade ratings. Auction rate securities are structured with short-term interest reset dates of generally less than 90 days, but with contractual maturities that can be well in excess of ten years. At the end of each reset period, which occurs every seven to twenty-eight days, investors can sell or continue to hold the securities at par value. If auction rate securities fail an auction, due to sell orders exceeding buy orders, the funds associated with a failed auction would not be accessible until a successful auction occurred, a buyer was found outside the auction process, the underlying securities matured or a settlement with the underwriter is reached. | ||||||||||||||||||
The following is a summary of the fair value of available-for-sale marketable securities we held at September 30, 2014 and December 31, 2013: | ||||||||||||||||||
30-Sep-14 | Amortized | Gross | Gross | Fair | ||||||||||||||
Cost | Unrealized | Unrealized | Value | |||||||||||||||
Gains | Losses | |||||||||||||||||
Security type | ||||||||||||||||||
Corporate debt securities-short term | $ | 45,956 | $ | 38 | $ | (5 | ) | $ | 45,989 | |||||||||
Corporate debt securities-long term | 5,315 | — | (8 | ) | 5,307 | |||||||||||||
Total available-for-sale marketable securities | $ | 51,271 | $ | 38 | $ | (13 | ) | $ | 51,296 | |||||||||
31-Dec-13 | Amortized | Gross | Gross | Fair | ||||||||||||||
Cost | Unrealized | Unrealized | Value | |||||||||||||||
Gains | Losses | |||||||||||||||||
Security type | ||||||||||||||||||
Corporate debt securities-short term | $ | 59,059 | $ | 62 | $ | (5 | ) | $ | 59,116 | |||||||||
Corporate debt securities-long term | 18,535 | 23 | (13 | ) | 18,545 | |||||||||||||
Total available-for-sale marketable securities | $ | 77,594 | $ | 85 | $ | (18 | ) | $ | 77,661 | |||||||||
Our available-for-sale marketable securities in a loss position at September 30, 2014 were in a continuous unrealized loss position for less than 12 months. The fair value of our available-for-sale marketable securities in a continuous unrealized loss position for more than 12 months was $2,377 at December 31, 2013. The unrealized loss on these marketable securities was $3 at December 31, 2013. As of September 30, 2014, our available-for-sale marketable securities all had contractual maturities of 18 months of less. | ||||||||||||||||||
The following is a summary of the fair value of trading securities we held at September 30, 2014 and December 31, 2013: | ||||||||||||||||||
30-Sep-14 | Amortized | Gross | Gross | Fair | ||||||||||||||
Cost | Unrealized | Unrealized | Value | |||||||||||||||
Gains | Losses | |||||||||||||||||
Security type | ||||||||||||||||||
Auction rate securities | $ | 2,100 | $ | — | $ | (179 | ) | $ | 1,921 | |||||||||
Total trading securities | $ | 2,100 | $ | — | $ | (179 | ) | $ | 1,921 | |||||||||
31-Dec-13 | Amortized | Gross | Gross | Fair | ||||||||||||||
Cost | Unrealized | Unrealized | Value | |||||||||||||||
Gains | Losses | |||||||||||||||||
Security type | ||||||||||||||||||
Auction rate securities | $ | 2,100 | $ | — | $ | (254 | ) | $ | 1,846 | |||||||||
Total trading securities | $ | 2,100 | $ | — | $ | (254 | ) | $ | 1,846 | |||||||||
The underlying collateral of our auction rate securities consists of student loans, supported by the federal government as part of the Federal Family Education Loan Program (FFELP). | ||||||||||||||||||
At September 30, 2014 and December 31, 2013, the Company’s auction rate securities are included in marketable securities-long term and total $1,921 and $1,846, respectively. | ||||||||||||||||||
The net decrease in value of our auction rate securities of $2 in the three months ended September 30, 2014, was recorded as a loss in other income (expenses) in the statement of operations and comprehensive loss. The net increase in value of our auction rate securities of $75 in the nine months ended September 30, 2014, was recorded as a gain in other income (expenses) in the statement of operations and comprehensive loss. | ||||||||||||||||||
The net increase in value of our auction rate securities of $4 in the three months ended September 30, 2013, was recorded as a gain in other income (expenses) in the statement of operations and comprehensive loss. The net decrease in value of our auction rate securities of $66 in the nine months ended September 30, 2013, was recorded as a loss in other income (expenses) in the statement of operations and comprehensive loss., | ||||||||||||||||||
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: | ||||||||||||||||||
September 30, | Quoted Prices in | Significant | Significant | |||||||||||||||
2014 | Active Markets | Other | Unobservable | |||||||||||||||
(Level 1) | Observable | Inputs | ||||||||||||||||
Inputs | (Level 3) | |||||||||||||||||
(Level 2) | ||||||||||||||||||
Cash equivalents | $ | 14,785 | $ | 14,785 | $ | — | $ | — | ||||||||||
Corporate debt securities-short term | 45,989 | — | 45,989 | — | ||||||||||||||
Corporate debt securities-long term | 5,307 | — | 5,307 | — | ||||||||||||||
Auction rate securities-long term | 1,921 | — | — | 1,921 | ||||||||||||||
Total | $ | 68,002 | $ | 14,785 | $ | 51,296 | $ | 1,921 | ||||||||||
December 31, | Quoted Prices in | Significant | Significant | |||||||||||||||
2013 | Active Markets | Other | Unobservable | |||||||||||||||
(Level 1) | Observable | Inputs | ||||||||||||||||
Inputs | (Level 3) | |||||||||||||||||
(Level 2) | ||||||||||||||||||
Cash equivalents | $ | 12,247 | $ | 12,247 | $ | — | $ | — | ||||||||||
Corporate debt securities-short term | 59,116 | — | 59,116 | — | ||||||||||||||
Corporate debt securities-long term | 18,545 | — | 18,545 | — | ||||||||||||||
Auction rate securities-long term | 1,846 | — | — | 1,846 | ||||||||||||||
Total | $ | 91,754 | $ | 12,247 | $ | 77,661 | $ | 1,846 | ||||||||||
Due to the lack of market quotes relating to our auction rate securities, the fair value measurements for our auction rate securities have been estimated using an income approach model (discounted cash flow analysis), which is exclusively based on Level 3 inputs. The model considers factors that reflect assumptions market participants would use in pricing including, among others, the collateralization underlying the investments, the creditworthiness of the counterparty, the expected future cash flows, liquidity premiums, the probability of successful auctions in the future, and interest rates. The assumptions used are subject to volatility and may change as the underlying sources of these assumptions and markets conditions change. | ||||||||||||||||||
The following table rolls forward the fair value of our auction rate securities and put option, whose fair values are determined by Level 3 inputs for 2014: | ||||||||||||||||||
Amount | ||||||||||||||||||
Balance at December 31, 2013 | $ | 1,846 | ||||||||||||||||
Gain on auction rate securities | 75 | |||||||||||||||||
Balance at September 30, 2014 | $ | 1,921 | ||||||||||||||||
The following table rolls forward the fair value of our auction rate securities and put option, whose fair values are determined by Level 3 inputs for 2013: | ||||||||||||||||||
Amount | ||||||||||||||||||
Balance at December 31, 2012 | $ | 1,789 | ||||||||||||||||
Loss on auction rate securities | (66 | ) | ||||||||||||||||
Balance at September 30, 2013 | $ | 1,723 | ||||||||||||||||
The following table provides quantitative information on the unobservable inputs of our fair value measurements for our Level 3 assets for the nine months ended September 30, 2014: | ||||||||||||||||||
Estimated | Valuation | Unobservable Inputs | Range | |||||||||||||||
Fair Value at | Technique | |||||||||||||||||
30-Sep-14 | ||||||||||||||||||
Auction rate securities | $ | 1,921 | Discounted cash flow | |||||||||||||||
Maximum rate | 1.56 | % | ||||||||||||||||
Liquidity risk premium | 3.00%–4.00 | % | ||||||||||||||||
Probability of earning maximum rate until maturity | 0.09%–0.15 | % | ||||||||||||||||
Probability of principal returned prior to maturity | 85.27%–87.47 | % | ||||||||||||||||
Probability of default | 12.44%–14.59 | % | ||||||||||||||||
A significant increase or decrease in the individual assumptions included above could result in a significantly lower or higher fair value measurement. |
ACCOUNTS_PAYABLE_AND_ACCRUED_E
ACCOUNTS PAYABLE AND ACCRUED EXPENSES | 9 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Payables and Accruals [Abstract] | ' | ||||||||
ACCOUNTS PAYABLE AND ACCRUED EXPENSES | ' | ||||||||
4. ACCOUNTS PAYABLE AND ACCRUED EXPENSES | |||||||||
Accounts payable and accrued expenses include the following at September 30, 2014 and December 31, 2013: | |||||||||
2014 | 2013 | ||||||||
Accounts payable | $ | 176 | $ | 146 | |||||
Accrued payroll | 1,700 | 2,556 | |||||||
Accrued outsourced pre-clinical and clinical fees | 3,951 | 4,702 | |||||||
Accrued professional fees | 528 | 660 | |||||||
Accrued restructuring costs | 502 | — | |||||||
Other accrued expenses | 338 | 406 | |||||||
$ | 7,195 | $ | 8,470 |
NET_LOSS_PER_SHARE
NET LOSS PER SHARE | 9 Months Ended |
Sep. 30, 2014 | |
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, the shares that would be issued upon the exercise of outstanding stock options, were 7,999,284 and 7,988,732 for the three and nine months ended September 30, 2014 and 2013, respectively. |
STOCKBASED_COMPENSATION_AND_ST
STOCK-BASED COMPENSATION AND STOCK PLANS | 9 Months Ended | ||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||
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 and nine months ended September 30, 2014 and 2013. | |||||||||||||||||
The following table presents stock-based compensation expense included in our Condensed Statements of Operations and Comprehensive Loss: | |||||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||
September 30, | September 30, | ||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
Research and development | $ | 186 | $ | 240 | $ | 854 | $ | 1,077 | |||||||||
General and administrative | 494 | 511 | 1,706 | 1,986 | |||||||||||||
Restructuring | 83 | 138 | 83 | 138 | |||||||||||||
Total stock-based compensation expense | $ | 763 | $ | 889 | $ | 2,643 | $ | 3,201 | |||||||||
In the three and nine months ended September 30, 2014 and 2013, 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 nine months ended September 30, 2014 was as follows: | |||||||||||||||||
Stock Options | Number of | Weighted Average | |||||||||||||||
Shares | Exercise Price | ||||||||||||||||
Outstanding as of December 31, 2013 | 7,511,814 | $ | 5.28 | ||||||||||||||
Granted | 1,150,119 | 2.47 | |||||||||||||||
Cancelled | (662,649 | ) | 4.97 | ||||||||||||||
Outstanding as of September 30, 2014 | 7,999,284 | $ | 4.91 | ||||||||||||||
Exercisable as of September 30, 2014 | 5,564,581 | $ | 5.32 | ||||||||||||||
The aggregate intrinsic value of options outstanding at September 30, 2014 was zero. The weighted average grant date fair value of options granted in the nine months ended September 30, 2014 and 2013 was $1.65 and $1.69 per share, respectively. In the nine months ended September 30, 2014, no options were exercised. The intrinsic value of options exercised in the nine months ended September 30, 2013 was $1. | |||||||||||||||||
Shares vested, expected to vest and exercisable at September 30, 2014 are as follows: | |||||||||||||||||
Shares | Weighted-Average | Weighted-Average | Aggregate | ||||||||||||||
Exercise Price | Remaining | Intrinsic | |||||||||||||||
Contractual | Value | ||||||||||||||||
Term (in years) | |||||||||||||||||
Vested and unvested expected to vest | 7,856,237 | $ | 4.91 | 5.6 | $ | — | |||||||||||
at September 30, 2014 | |||||||||||||||||
Exercisable at September 30, 2014 | 5,564,581 | $ | 5.32 | 4.4 | $ | — | |||||||||||
The total compensation cost not yet recognized as of September 30, 2014 related to non-vested option awards was $4.6 million, which will be recognized over a weighted-average period of 2.0 years. During the nine months ended September 30, 2014, 428,304 options expired and 225,345 options were forfeited. The weighted average remaining contractual life for options exercisable at September 30, 2014 was 4.4 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 September 30, 2014, 65,991 shares have been forfeited, and 50,239 shares have vested. We recognized share-based compensation expense related to restricted stock of $77 and $166 for the nine months ended September 30, 2014 and 2013, respectively. | |||||||||||||||||
Restricted stock activity under the Plan for the nine months ended September 30, 2014 was as follows: | |||||||||||||||||
Restricted Stock | Number of Shares | Weighted Average | |||||||||||||||
Grant Date | |||||||||||||||||
Fair Value | |||||||||||||||||
Unvested as of December 31, 2013 | 195,777 | $ | 2.51 | ||||||||||||||
Vested | (49,041 | ) | 2.51 | ||||||||||||||
Cancelled | (20,269 | ) | 2.51 | ||||||||||||||
Unvested as of September 30, 2014 | 126,467 | $ | 2.51 | ||||||||||||||
The fair value of restricted stock vested in the nine months ended September 30, 2014 and 2013 was $55 and $206, 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% vest annually over the next 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 September 30, 2014, no expense has been recorded for any performance-based stock units granted to the CEO, COO, or CMO. |
RECENT_ACCOUNTING_PRONOUNCEMEN
RECENT ACCOUNTING PRONOUNCEMENTS | 9 Months Ended |
Sep. 30, 2014 | |
New Accounting Pronouncements and Changes in Accounting Principles [Abstract] | ' |
RECENT ACCOUNTING PRONOUNCEMENTS | ' |
7. 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 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 beginning 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 financial statements or 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 are currently evaluating the potential impact that this ASU may have on our financial position and 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. The new standard will be effective for us on January 1, 2017 and allows for prospective or retrospective application. We are currently evaluating the potential adoption methods as well as the impact this ASU may have on our financial position and results of operations. | |
In July 2013, the FASB issued an update, which is intended to eliminate the diversity that is in practice with regard to the financial statement presentation of unrecognized tax benefits when a net operating loss carryforward, a similar tax loss, or a tax credit carryforward exists. We adopted this standard in the first quarter of fiscal year 2014. The adoption of this standard did not have a material impact on our financial condition or results of operations. |
INCOME_TAXES
INCOME TAXES | 9 Months Ended |
Sep. 30, 2014 | |
Income Tax Disclosure [Abstract] | ' |
INCOME TAXES | ' |
8. INCOME TAXES | |
As of December 31, 2013, we had federal NOL, state NOL, and research and development credit carryforwards of approximately $298,727, $118,695 and $27,067 respectively, expiring from 2014 to 2033, which can be used to offset future income tax liabilities. Federal capital loss carry forwards of approximately $571, expiring in 2015, can be used to offset future federal capital gain income. Approximately $15,006 of our federal NOL and $855 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 September 30, 2014 and December 31, 2013, 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 September 30, 2014 and December 31, 2013, we had no accrued interest or penalties related to uncertain tax positions. Our U.S. federal tax returns for the tax years 2011 through 2013 and our state tax returns for the tax years 2010 through 2013 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, 2014, 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. |
NOTES_PAYABLE
NOTES PAYABLE | 9 Months Ended |
Sep. 30, 2014 | |
Notes Payable [Abstract] | ' |
NOTES PAYABLE | ' |
9. NOTES PAYABLE | |
In October 2008, we entered into a margin loan agreement with a financial institution collateralized by $2.9 million of our auction rate securities and borrowed $1.7 million which is the maximum amount allowed under this facility. The amount outstanding under this facility is $1.7 million at September 30, 2014 and 2013, collateralized by $2.1 million of auction rate securities at cost. Interest expense was $11 and $28 and $8 and $18 for the three and nine months ended September 30, 2014 and 2013, respectively. | |
Management believes the carrying value of the note payable approximates its fair value for these borrowings and is classified as a Level 2 measurement due to use of valuation inputs based on similar liabilities in the market. |
RESTRUCTURING_AND_OTHER_COSTS
RESTRUCTURING AND OTHER COSTS | 9 Months Ended |
Sep. 30, 2014 | |
Restructuring and Related Activities [Abstract] | ' |
RESTRUCTURING AND OTHER COSTS | ' |
10. RESTRUCTURING AND OTHER COSTS | |
In July 2013, we implemented a focused reduction in our workforce of 26 positions, resulting in a remaining workforce of approximately 68 employees. This action was intended to align human and financial resources with our primary focus on clinical-stage development, while retaining our core discovery capabilities. The costs associated with this action were comprised of severance payments of $434 and benefits continuation costs of $94. In the quarter ended September 30, 2013, $403 of these costs was paid and the remaining amount was paid by December 31, 2013. In addition, in the three months ended September 30, 2013, we incurred non-cash charges of $139 related to the modification of employee stock options. | |
On July 30, 2014, we approved plans to restructure our operations to better align our human and financial resources with our primary focus on clinical stage development programs and to extend our cash runway beyond the anticipated time for achievement of key milestones, such as the completion of the METIV-HCC trial. Commencing on August 4, 2014, we began to reduce our current workforce from 62 to approximately 40 employees by the end of the year. Most of this reduction came from our Discovery Group, which has been engaged primarily in early-stage, pre-clinical research. The costs associated with this action were comprised of severance payments of $662 and benefits continuation costs of $74. In the quarter ended September 30, 2014, $234 of these costs was paid and the remaining amount is expected to be paid by March 31, 2015. In addition, in the three months ended September 30, 2014, we incurred non-cash charges of $83 related to the modification of employee stock options, and $280 for impairment of property and equipment impacted by the restructuring. |
MARKETABLE_SECURITIES_AND_FAIR1
MARKETABLE SECURITIES AND FAIR VALUE MEASUREMENTS (Tables) | 9 Months Ended | |||||||||||||||||
Sep. 30, 2014 | ||||||||||||||||||
Marketable Securities and Fair Value Measurements [Abstract] | ' | |||||||||||||||||
Schedule of fair value of available-for-sale marketable securities | ' | |||||||||||||||||
30-Sep-14 | Amortized | Gross | Gross | Fair | ||||||||||||||
Cost | Unrealized | Unrealized | Value | |||||||||||||||
Gains | Losses | |||||||||||||||||
Security type | ||||||||||||||||||
Corporate debt securities-short term | $ | 45,956 | $ | 38 | $ | (5 | ) | $ | 45,989 | |||||||||
Corporate debt securities-long term | 5,315 | — | (8 | ) | 5,307 | |||||||||||||
Total available-for-sale marketable securities | $ | 51,271 | $ | 38 | $ | (13 | ) | $ | 51,296 | |||||||||
31-Dec-13 | Amortized | Gross | Gross | Fair | ||||||||||||||
Cost | Unrealized | Unrealized | Value | |||||||||||||||
Gains | Losses | |||||||||||||||||
Security type | ||||||||||||||||||
Corporate debt securities-short term | $ | 59,059 | $ | 62 | $ | (5 | ) | $ | 59,116 | |||||||||
Corporate debt securities-long term | 18,535 | 23 | (13 | ) | 18,545 | |||||||||||||
Total available-for-sale marketable securities | $ | 77,594 | $ | 85 | $ | (18 | ) | $ | 77,661 | |||||||||
Schedule of fair value of trading securities | ' | |||||||||||||||||
30-Sep-14 | Amortized | Gross | Gross | Fair | ||||||||||||||
Cost | Unrealized | Unrealized | Value | |||||||||||||||
Gains | Losses | |||||||||||||||||
Security type | ||||||||||||||||||
Auction rate securities | $ | 2,100 | $ | — | $ | (179 | ) | $ | 1,921 | |||||||||
Total trading securities | $ | 2,100 | $ | — | $ | (179 | ) | $ | 1,921 | |||||||||
31-Dec-13 | Amortized | Gross | Gross | Fair | ||||||||||||||
Cost | Unrealized | Unrealized | Value | |||||||||||||||
Gains | Losses | |||||||||||||||||
Security type | ||||||||||||||||||
Auction rate securities | $ | 2,100 | $ | — | $ | (254 | ) | $ | 1,846 | |||||||||
Total trading securities | $ | 2,100 | $ | — | $ | (254 | ) | $ | 1,846 | |||||||||
Schedule of assets measured at fair value on a recurring basis | ' | |||||||||||||||||
September 30, | Quoted Prices in | Significant | Significant | |||||||||||||||
2014 | Active Markets | Other | Unobservable | |||||||||||||||
(Level 1) | Observable | Inputs | ||||||||||||||||
Inputs | (Level 3) | |||||||||||||||||
(Level 2) | ||||||||||||||||||
Cash equivalents | $ | 14,785 | $ | 14,785 | $ | — | $ | — | ||||||||||
Corporate debt securities-short term | 45,989 | — | 45,989 | — | ||||||||||||||
Corporate debt securities-long term | 5,307 | — | 5,307 | — | ||||||||||||||
Auction rate securities-long term | 1,921 | — | — | 1,921 | ||||||||||||||
Total | $ | 68,002 | $ | 14,785 | $ | 51,296 | $ | 1,921 | ||||||||||
December 31, | Quoted Prices in | Significant | Significant | |||||||||||||||
2013 | Active Markets | Other | Unobservable | |||||||||||||||
(Level 1) | Observable | Inputs | ||||||||||||||||
Inputs | (Level 3) | |||||||||||||||||
(Level 2) | ||||||||||||||||||
Cash equivalents | $ | 12,247 | $ | 12,247 | $ | — | $ | — | ||||||||||
Corporate debt securities-short term | 59,116 | — | 59,116 | — | ||||||||||||||
Corporate debt securities-long term | 18,545 | — | 18,545 | — | ||||||||||||||
Auction rate securities-long term | 1,846 | — | — | 1,846 | ||||||||||||||
Total | $ | 91,754 | $ | 12,247 | $ | 77,661 | $ | 1,846 | ||||||||||
Schedule of fair value of auction rate securities | ' | |||||||||||||||||
The following table rolls forward the fair value of our auction rate securities and put option, whose fair values are determined by Level 3 inputs for 2014: | ||||||||||||||||||
Amount | ||||||||||||||||||
Balance at December 31, 2013 | $ | 1,846 | ||||||||||||||||
Gain on auction rate securities | 75 | |||||||||||||||||
Balance at September 30, 2014 | $ | 1,921 | ||||||||||||||||
The following table rolls forward the fair value of our auction rate securities and put option, whose fair values are determined by Level 3 inputs for 2013: | ||||||||||||||||||
Amount | ||||||||||||||||||
Balance at December 31, 2012 | $ | 1,789 | ||||||||||||||||
Loss on auction rate securities | (66 | ) | ||||||||||||||||
Balance at September 30, 2013 | $ | 1,723 | ||||||||||||||||
Schedule of quantitative information on the unobservable inputs of our fair value measurements for our Level 3 assets | ' | |||||||||||||||||
Estimated | Valuation | Unobservable Inputs | Range | |||||||||||||||
Fair Value at | Technique | |||||||||||||||||
30-Sep-14 | ||||||||||||||||||
Auction rate securities | $ | 1,921 | Discounted cash flow | |||||||||||||||
Maximum rate | 1.56 | % | ||||||||||||||||
Liquidity risk premium | 3.00%–4.00 | % | ||||||||||||||||
Probability of earning maximum rate until maturity | 0.09%–0.15 | % | ||||||||||||||||
Probability of principal returned prior to maturity | 85.27%–87.47 | % | ||||||||||||||||
Probability of default | 12.44%–14.59 | % |
ACCOUNTS_PAYABLE_AND_ACCRUED_E1
ACCOUNTS PAYABLE AND ACCRUED EXPENSES (Tables) | 9 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Payables and Accruals [Abstract] | ' | ||||||||
Schedule of accounts payable and accrued expense | ' | ||||||||
2014 | 2013 | ||||||||
Accounts payable | $ | 176 | $ | 146 | |||||
Accrued payroll | 1,700 | 2,556 | |||||||
Accrued outsourced pre-clinical and clinical fees | 3,951 | 4,702 | |||||||
Accrued professional fees | 528 | 660 | |||||||
Accrued restructuring costs | 502 | — | |||||||
Other accrued expenses | 338 | 406 | |||||||
$ | 7,195 | $ | 8,470 |
STOCKBASED_COMPENSATION_AND_ST1
STOCK-BASED COMPENSATION AND STOCK PLANS (Tables) | 9 Months Ended | ||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||
Compensation and Retirement Disclosure [Abstract] | ' | ||||||||||||||||
Schedule of stock-based compensation expense | ' | ||||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||
September 30, | September 30, | ||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
Research and development | $ | 186 | $ | 240 | $ | 854 | $ | 1,077 | |||||||||
General and administrative | 494 | 511 | 1,706 | 1,986 | |||||||||||||
Restructuring | 83 | 138 | 83 | 138 | |||||||||||||
Total stock-based compensation expense | $ | 763 | $ | 889 | $ | 2,643 | $ | 3,201 | |||||||||
Schedule of activity of options under stock plans | ' | ||||||||||||||||
Stock Options | Number of | Weighted Average | |||||||||||||||
Shares | Exercise Price | ||||||||||||||||
Outstanding as of December 31, 2013 | 7,511,814 | $ | 5.28 | ||||||||||||||
Granted | 1,150,119 | 2.47 | |||||||||||||||
Cancelled | (662,649 | ) | 4.97 | ||||||||||||||
Outstanding as of September 30, 2014 | 7,999,284 | $ | 4.91 | ||||||||||||||
Exercisable as of September 30, 2014 | 5,564,581 | $ | 5.32 | ||||||||||||||
Schedule of shares vested, expected to vest and exercisable | ' | ||||||||||||||||
Shares | Weighted-Average | Weighted-Average | Aggregate | ||||||||||||||
Exercise Price | Remaining | Intrinsic | |||||||||||||||
Contractual | Value | ||||||||||||||||
Term (in years) | |||||||||||||||||
Vested and unvested expected to vest | 7,856,237 | $ | 4.91 | 5.6 | $ | — | |||||||||||
at September 30, 2014 | |||||||||||||||||
Exercisable at September 30, 2014 | 5,564,581 | $ | 5.32 | 4.4 | $ | — | |||||||||||
Schedule of restricted stock activity | ' | ||||||||||||||||
Restricted Stock | Number of Shares | Weighted Average | |||||||||||||||
Grant Date | |||||||||||||||||
Fair Value | |||||||||||||||||
Unvested as of December 31, 2013 | 195,777 | $ | 2.51 | ||||||||||||||
Vested | (49,041 | ) | 2.51 | ||||||||||||||
Cancelled | (20,269 | ) | 2.51 | ||||||||||||||
Unvested as of September 30, 2014 | 126,467 | $ | 2.51 |
NATURE_OF_OPERATIONS_AND_BASIS1
NATURE OF OPERATIONS AND BASIS OF PRESENTATION (Detail Textuals) (USD $) | Sep. 30, 2014 | Sep. 30, 2014 | Jan. 16, 2014 | Dec. 31, 2011 | Jan. 31, 2013 | Dec. 31, 2011 | Sep. 30, 2014 | Sep. 30, 2014 |
In Millions, unless otherwise specified | Patient | Kyowa Hakko Kirin Co. Ltd. | Kyowa Hakko Kirin Co. Ltd. | License agreement | License agreement | License agreement | Tivantinib dosage | Other Tivantinib Trials |
Clinical_Site | Patient | Patient | Kyowa Hakko Kirin Co. Ltd. | Daiichi Sankyo Co. Ltd | Daiichi Sankyo Co. Ltd | Milligram | Milligram | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' |
Quantity of dosage twice daily | ' | ' | ' | ' | ' | ' | 240 | ' |
Quantity of dosage twice daily after reduction | ' | ' | ' | ' | ' | ' | 120 | ' |
Quantity of dosage | ' | ' | ' | ' | ' | ' | ' | 240 |
Number of patient planned to be enrolled | 300 | 160 | 460 | ' | ' | ' | ' | ' |
Number of clinical sites | 120 | ' | ' | ' | ' | ' | ' | ' |
Number of actual patients included in the final analysis | ' | 307 | ' | ' | ' | ' | ' | ' |
Milestone payment received | ' | ' | ' | $10 | $15 | $25 | ' | ' |
COLLABORATIONS_AND_ALLIANCES_D
COLLABORATIONS AND ALLIANCES (Detail Textuals) (USD $) | 3 Months Ended | 9 Months Ended | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Nov. 30, 2011 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Dec. 31, 2011 | |
License agreement | License agreement | License agreement | License agreement | License agreement | |||||
Daiichi Sankyo ARQ 092 Agreement | Daiichi Sankyo ARQ 092 Agreement | Daiichi Sankyo ARQ 092 Agreement | Daiichi Sankyo ARQ 092 Agreement | Daiichi Sankyo ARQ 092 Agreement | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Notice period for termination of contract | ' | ' | ' | ' | ' | ' | '90 days | ' | ' |
Upfront payment received | ' | ' | ' | ' | $10,000,000 | ' | ' | ' | ' |
Research and development revenue | $2,662,000 | $3,542,000 | $8,239,000 | $13,639,000 | ' | $0 | ' | $1,300,000 | $10,000,000 |
COLLABORATIONS_AND_ALLIANCES_D1
COLLABORATIONS AND ALLIANCES (Detail Textuals 1) (USD $) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||
Jan. 31, 2013 | Feb. 28, 2011 | Dec. 31, 2008 | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' | ' | ' | ' | ' | ' |
Research and development revenue | ' | ' | ' | $2,662,000 | $3,542,000 | $8,239,000 | $13,639,000 |
Daiichi Sankyo Tivantinib Agreement | ' | ' | ' | ' | ' | ' | ' |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' | ' | ' | ' | ' | ' |
Upfront payment received | ' | ' | 60,000,000 | ' | ' | ' | ' |
Additional potential development and sales milestone payments | ' | ' | 560,000,000 | ' | ' | ' | ' |
Cumulative share of phase 3 collaboration costs | ' | ' | ' | ' | ' | 87,800,000 | ' |
Milestone payment received | 15,000,000 | 25,000,000 | ' | ' | ' | ' | ' |
Cumulative share of phase 3 collaboration costs in excess of milestones amounts received | ' | ' | ' | ' | ' | 47,800,000 | ' |
Non Phase 3 collaboration costs incurred recognized as revenue (contra-revenue) | ' | ' | ' | -102,000 | 23,000 | ' | 100,000 |
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 | ' |
Non Phase 3 collaboration cost of contra revenue | ' | ' | ' | ' | ' | ' | 200,000 |
Non Phase 3 collaboration cost of revenue | ' | ' | ' | ' | ' | ' | 300,000 |
Research and development revenue | ' | ' | ' | 1,200,000 | 2,100,000 | 4,000,000 | 6,300,000 |
Deferred revenue | ' | ' | ' | $9,400,000 | ' | $9,400,000 | ' |
COLLABORATIONS_AND_ALLIANCES_D2
COLLABORATIONS AND ALLIANCES (Detail Textuals 2) (USD $) | 3 Months Ended | 9 Months Ended | 0 Months Ended | 1 Months Ended | 3 Months Ended | 9 Months Ended | 1 Months Ended | |||||||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | 7-May-07 | Apr. 27, 2007 | Sep. 30, 2014 | Sep. 30, 2013 | Mar. 31, 2007 | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2010 | Aug. 31, 2011 | Feb. 29, 2008 | |
Kyowa Hakko Kirin Licensing Agreement | Kyowa Hakko Kirin Licensing Agreement | Kyowa Hakko Kirin Licensing Agreement | Kyowa Hakko Kirin Licensing Agreement | Kyowa Hakko Kirin Licensing Agreement | Kyowa Hakko Kirin Licensing Agreement | Kyowa Hakko Kirin Licensing Agreement | Kyowa Hakko Kirin Licensing Agreement | Kyowa Hakko Kirin Licensing Agreement | Kyowa Hakko Kirin Licensing Agreement | |||||
Phase Two trial Kyowa Hakko Kirin | Phase Three Attention Trial Asia | Kyowa Hakko Kirin | ||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Upfront payment received | ' | ' | ' | ' | $27,000,000 | ' | ' | ' | $3,000,000 | ' | ' | ' | ' | ' |
Upfront and potential development milestone payments | ' | ' | ' | ' | ' | 123,000,000 | ' | ' | ' | ' | ' | ' | ' | ' |
Cash upfront licensing payments - total to date | ' | ' | ' | ' | ' | 30,000,000 | ' | ' | ' | ' | ' | ' | ' | ' |
Milestone payment received | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 5,000,000 | 10,000,000 | 3,000,000 |
Percentage of royalties expected to be received - lower range | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 'mid-teen percent |
Percentage of royalties expected to be received - upper range | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 'low-twenty percent |
Notice period for termination of contract | ' | ' | ' | ' | ' | ' | '90 days | ' | ' | ' | ' | ' | ' | ' |
Research and development revenue | 2,662,000 | 3,542,000 | 8,239,000 | 13,639,000 | ' | ' | 1,400,000 | 1,400,000 | ' | 4,300,000 | 4,300,000 | ' | ' | ' |
Deferred revenue | ' | ' | ' | ' | ' | ' | 9,000,000 | ' | ' | 9,000,000 | ' | ' | ' | ' |
Payment received on completion of one time research project | ' | ' | ' | $1,800,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
MARKETABLE_SECURITIES_AND_FAIR2
MARKETABLE SECURITIES AND FAIR VALUE MEASUREMENTS - Summary of fair value of available-for-sale securities (Details) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Schedule of Available-for-sale Securities [Line Items] | ' | ' |
Amortized Cost | $51,271 | $77,594 |
Gross Unrealized Gains | 38 | 85 |
Gross Unrealized Losses | -13 | -18 |
Fair Value | 51,296 | 77,661 |
Corporate debt securities | Short term | ' | ' |
Schedule of Available-for-sale Securities [Line Items] | ' | ' |
Amortized Cost | 45,956 | 59,059 |
Gross Unrealized Gains | 38 | 62 |
Gross Unrealized Losses | -5 | -5 |
Fair Value | 45,989 | 59,116 |
Corporate debt securities | Long term | ' | ' |
Schedule of Available-for-sale Securities [Line Items] | ' | ' |
Amortized Cost | 5,315 | 18,535 |
Gross Unrealized Gains | ' | 23 |
Gross Unrealized Losses | -8 | -13 |
Fair Value | $5,307 | $18,545 |
MARKETABLE_SECURITIES_AND_FAIR3
MARKETABLE SECURITIES AND FAIR VALUE MEASUREMENTS - Summary of fair value of trading securities (Details 1) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Schedule of Trading Securities and Other Trading Assets [Line Items] | ' | ' |
Amortized Cost | $2,100 | $2,100 |
Gross Unrealized Gains | ' | ' |
Gross Unrealized Losses | -179 | -254 |
Fair Value | 1,921 | 1,846 |
Auction rate securities | ' | ' |
Schedule of Trading Securities and Other Trading Assets [Line Items] | ' | ' |
Amortized Cost | 2,100 | 2,100 |
Gross Unrealized Gains | ' | ' |
Gross Unrealized Losses | -179 | -254 |
Fair Value | $1,921 | $1,846 |
MARKETABLE_SECURITIES_AND_FAIR4
MARKETABLE SECURITIES AND FAIR VALUE MEASUREMENTS - Assets measured at fair value on a recurring basis (Details 2) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ' | ' |
Corporate debt securities-short term & long term | $51,296 | $77,661 |
Auction rate securities-long term | 1,921 | 1,846 |
Auction rate securities | ' | ' |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ' | ' |
Auction rate securities-long term | 1,921 | 1,846 |
Fair Value, Measurements, Recurring | ' | ' |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ' | ' |
Cash equivalents | 14,785 | 12,247 |
Total | 68,002 | 91,754 |
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 & long term | 45,989 | 59,116 |
Fair Value, Measurements, Recurring | Corporate debt securities | Long term | ' | ' |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ' | ' |
Corporate debt securities-short term & long term | 5,307 | 18,545 |
Fair Value, Measurements, Recurring | Auction rate securities | Long term | ' | ' |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ' | ' |
Auction rate securities-long term | 1,921 | 1,846 |
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 | 14,785 | 12,247 |
Total | 14,785 | 12,247 |
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 & long term | ' | ' |
Fair Value, Measurements, Recurring | Quoted Prices in Active Markets (Level 1) | Corporate debt securities | Long term | ' | ' |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ' | ' |
Corporate debt securities-short term & long term | ' | ' |
Fair Value, Measurements, Recurring | Quoted Prices in Active Markets (Level 1) | Auction rate securities | Long term | ' | ' |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ' | ' |
Auction rate securities-long 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 | 51,296 | 77,661 |
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 & long term | 45,989 | 59,116 |
Fair Value, Measurements, Recurring | Significant Other Observable Inputs (Level 2) | Corporate debt securities | Long term | ' | ' |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ' | ' |
Corporate debt securities-short term & long term | 5,307 | 18,545 |
Fair Value, Measurements, Recurring | Significant Other Observable Inputs (Level 2) | Auction rate securities | Long term | ' | ' |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ' | ' |
Auction rate securities-long term | ' | ' |
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 | 1,921 | 1,846 |
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 & long term | ' | ' |
Fair Value, Measurements, Recurring | Significant Unobservable Inputs (Level 3) | Corporate debt securities | Long term | ' | ' |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ' | ' |
Corporate debt securities-short term & long term | ' | ' |
Fair Value, Measurements, Recurring | Significant Unobservable Inputs (Level 3) | Auction rate securities | Long term | ' | ' |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ' | ' |
Auction rate securities-long term | $1,921 | $1,846 |
MARKETABLE_SECURITIES_AND_FAIR5
MARKETABLE SECURITIES AND FAIR VALUE MEASUREMENTS - Roll forward auction rate securities (Details 3) (Auction rate securities, Fair Value, Inputs, Level 3, USD $) | 9 Months Ended | |
In Thousands, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2013 |
Auction rate securities | Fair Value, Inputs, Level 3 | ' | ' |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ' | ' |
Balance | $1,846 | $1,789 |
Gain (Loss) on auction rate securities | 75 | -66 |
Balance | $1,921 | $1,723 |
MARKETABLE_SECURITIES_AND_FAIR6
MARKETABLE SECURITIES AND FAIR VALUE MEASUREMENTS - Summary of unobservable inputs of fair value measurements (Details 4) (Fair Value, Inputs, Level 3, Auction rate securities, USD $) | 9 Months Ended |
In Thousands, unless otherwise specified | Sep. 30, 2014 |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ' |
Auction rate securities | $1,921 |
Fair value measurements, Valuation Technique | 'Discounted cash flow |
Discounted cash flow | ' |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ' |
Maximum rate | 1.56% |
Discounted cash flow | Minimum | ' |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ' |
Liquidity risk premium | 3.00% |
Probability of earning maximum rate until maturity | 0.09% |
Probability of principal returned prior to maturity | 85.27% |
Probability of default | 12.44% |
Discounted cash flow | Maximum | ' |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ' |
Liquidity risk premium | 4.00% |
Probability of earning maximum rate until maturity | 0.15% |
Probability of principal returned prior to maturity | 87.47% |
Probability of default | 14.59% |
MARKETABLE_SECURITIES_AND_FAIR7
MARKETABLE SECURITIES AND FAIR VALUE MEASUREMENTS (Detail Textuals) (USD $) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Dec. 31, 2013 |
Marketable Securities and Fair Value Measurements [Abstract] | ' | ' | ' | ' | ' |
Minimum short term interest reset period for auction rate securities | ' | ' | '90 days | ' | ' |
Minimum period for contractual maturities | ' | ' | '10 years | ' | ' |
Reset period frequency | ' | ' | 'Seven to twenty-eight days | ' | ' |
Fair value of available marketable securities unrealized loss position | ' | ' | ' | ' | $2,377 |
Unrealized loss on marketable securities | ' | ' | ' | ' | 3 |
Auction rate securities-long term | 1,921 | ' | 1,921 | ' | 1,846 |
Gain (loss) on auction rate securities | ($2) | $4 | $75 | ($66) | ' |
ACCOUNTS_PAYABLE_AND_ACCRUED_E2
ACCOUNTS PAYABLE AND ACCRUED EXPENSES - Summary of accounts payable and accrued expenses (Details) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Payables and Accruals [Abstract] | ' | ' |
Accounts payable | $176 | $146 |
Accrued payroll | 1,700 | 2,556 |
Accrued outsourced pre-clinical and clinical fees | 3,951 | 4,702 |
Accrued professional fees | 528 | 660 |
Accrued restructuring costs | 502 | ' |
Other accrued expenses | 338 | 406 |
Accounts payable and accrued expenses, Total | $7,195 | $8,470 |
NET_LOSS_PER_SHARE_Detail_Text
NET LOSS PER SHARE (Detail Textuals) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | |
Earnings Per Share [Abstract] | ' | ' | ' | ' |
Potential common shares issued upon exercise of outstanding stock options | 7,999,284 | 7,988,732 | 7,999,284 | 7,988,732 |
STOCKBASED_COMPENSATION_AND_ST2
STOCK-BASED COMPENSATION AND STOCK PLANS - Stock-based compensation expense (Details) (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' | ' | ' |
Total stock-based compensation expense | $763 | $889 | $2,643 | $3,201 |
Research and development | ' | ' | ' | ' |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' | ' | ' |
Total stock-based compensation expense | 186 | 240 | 854 | 1,077 |
General and administrative | ' | ' | ' | ' |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' | ' | ' |
Total stock-based compensation expense | 494 | 511 | 1,706 | 1,986 |
Restructuring | ' | ' | ' | ' |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' | ' | ' |
Total stock-based compensation expense | $83 | $138 | $83 | $138 |
STOCKBASED_COMPENSATION_AND_ST3
STOCK-BASED COMPENSATION AND STOCK PLANS - Option activity (Details 1) (Stock Options, USD $) | 9 Months Ended |
Sep. 30, 2014 | |
Stock Options | ' |
Number of Shares | ' |
Outstanding as of December 31, 2013 | 7,511,814 |
Granted | 1,150,119 |
Cancelled | -662,649 |
Outstanding as of September 30, 2014 | 7,999,284 |
Exercisable as of September 30, 2014 | 5,564,581 |
Weighted Average Exercise Price | ' |
Outstanding as of December 31, 2013 | $5.28 |
Granted | $2.47 |
Cancelled | $4.97 |
Outstanding as of September 30, 2014 | $4.91 |
Exercisable as of September 30, 2014 | $5.32 |
STOCKBASED_COMPENSATION_AND_ST4
STOCK-BASED COMPENSATION AND STOCK PLANS - Shares vested, expected to vest and exercisable (Details 2) (Stock Options, USD $) | 9 Months Ended |
Sep. 30, 2014 | |
Stock Options | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' |
Vested and unvested expected to vest shares | 7,856,237 |
Vested and unvested expected to vest, weighted-average exercise price | $4.91 |
Vested and unvested expected to vest, weighted-average remaining contractual term (in years) | '5 years 7 months 6 days |
Vested and unvested expected to vest, aggregate intrinsic value | ' |
Exercisable shares | 5,564,581 |
Exercisable, weighted-average exercise price | $5.32 |
Exercisable, weighted-average remaining contractual term (in years) | '4 years 4 months 24 days |
Exercisable, aggregate intrinsic value | ' |
STOCKBASED_COMPENSATION_AND_ST5
STOCK-BASED COMPENSATION AND STOCK PLANS - Restricted stock activity (Details 3) (Restricted Stock, USD $) | 9 Months Ended |
Sep. 30, 2014 | |
Restricted Stock | ' |
Number of Shares | ' |
Unvested as of December 31, 2013 | 195,777 |
Vested | -49,041 |
Cancelled | -20,269 |
Unvested as of September 30, 2014 | 126,467 |
Weighted Average Grant Date Fair Value | ' |
Unvested as of December 31, 2013 | $2.51 |
Vested | $2.51 |
Cancelled | $2.51 |
Unvested as of September 30, 2014 | $2.51 |
STOCKBASED_COMPENSATION_AND_ST6
STOCK-BASED COMPENSATION AND STOCK PLANS (Detail Textuals) (Stock Options, USD $) | 9 Months Ended | |
Sep. 30, 2014 | Sep. 30, 2013 | |
Stock Options | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' |
Aggregate intrinsic value of options outstanding | $0 | ' |
Weighted average grant date fair value of options granted (in dollars per share) | $1.65 | $1.69 |
Intrinsic value of options exercised | ' | 1,000 |
Compensation cost not yet recognized related to non-vested option awards | $4,600,000 | ' |
Compensation cost related to non-vested option awards recognition period | '2 years | ' |
Number of the non-vested options shares expired during the period | 428,304 | ' |
Number of options forfeited during the period | 225,345 | ' |
Weighted average remaining contractual life for options exercisable | '4 years 4 months 24 days | ' |
STOCKBASED_COMPENSATION_AND_ST7
STOCK-BASED COMPENSATION AND STOCK PLANS (Detail Textuals 1) (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' | ' |
Share-based compensation expense | $763 | $889 | $2,643 | $3,201 |
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 | ' | ' | 65,991 | ' |
Number of shares vested during the period | ' | ' | 50,239 | ' |
Share-based compensation expense | ' | ' | 77 | 166 |
Fair value of stock vested during period | ' | ' | $55 | $206 |
STOCKBASED_COMPENSATION_AND_ST8
STOCK-BASED COMPENSATION AND STOCK PLANS (Detail Textuals 2) | 9 Months Ended | 1 Months Ended | ||||||
Sep. 30, 2014 | Jul. 31, 2010 | Jul. 31, 2010 | Jul. 31, 2010 | Jul. 31, 2010 | Mar. 31, 2013 | Feb. 29, 2012 | Mar. 31, 2013 | |
Stock Options | Chief executive officer employment agreement | Chief executive officer employment agreement | Chief executive officer employment agreement | Chief executive officer employment agreement | Chief medical officer employment agreement | Chief medical officer employment agreement | Chief operating officer employment agreement | |
Chief executive officer (CEO) | Chief executive officer (CEO) | Chief executive officer (CEO) | Chief executive officer (CEO) | Chief medical officer (CMO) | Chief medical officer (CMO) | Chief operating officer (COO) | ||
Stock Options | Stock Options | Stock Options | Performance-based stock units | Performance-based stock units | Performance-based stock units | Performance-based stock units | ||
Vested upon grant | Vest annually | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' |
Granted | 1,150,119 | 100,000 | ' | ' | ' | ' | ' | ' |
Percentage of options vested | ' | ' | 25.00% | 25.00% | ' | ' | ' | ' |
Award vesting period | ' | ' | ' | '3 years | ' | ' | ' | ' |
Number of stocks vested during the period | ' | ' | ' | ' | 390,000 | 120,000 | 50,000 | 125,000 |
INCOME_TAXES_Detail_Textuals
INCOME TAXES (Detail Textuals) (USD $) | 9 Months Ended | 12 Months Ended | |||
In Thousands, unless otherwise specified | Sep. 30, 2014 | Dec. 31, 2013 | Dec. 31, 2013 | Dec. 31, 2013 | Dec. 31, 2013 |
Federal income tax | State income tax | Research and development credit carryforwards | Capital loss carryforward | ||
Federal income tax | |||||
Operating Loss Carryforwards [Line Items] | ' | ' | ' | ' | ' |
Net operating loss | ' | $298,727 | $118,695 | $27,067 | ' |
Net capital loss carryforwards | ' | ' | ' | ' | 571 |
Net operating loss generated from excess tax deduction from share based awards | ' | $15,006 | $855 | ' | ' |
Increase in ownership percentage of certain stockholders or public groups | 'more than 50 percentage points | ' | ' | ' | ' |
Ownership change, increase in ownership percentage, term | '3 years | ' | ' | ' | ' |
NOTES_PAYABLE_Detail_Textuals
NOTES PAYABLE (Detail Textuals) (USD $) | 3 Months Ended | 9 Months Ended | |||||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Oct. 31, 2008 | |
Notes payable | Notes payable | Notes payable | |||||
Debt Instrument [Line Items] | ' | ' | ' | ' | ' | ' | ' |
Fair value of collateralized auction rate securities | ' | ' | ' | ' | $2,100,000 | $2,100,000 | $2,900,000 |
Debt instrument maximum borrowed amount | ' | ' | ' | ' | ' | ' | 1,700,000 |
Amount outstanding under margin loan agreement facility | ' | ' | ' | ' | 1,700,000 | 1,700,000 | ' |
Interest expense | $11,000 | $8,000 | $28,000 | $18,000 | ' | ' | ' |
RESTRUCTURING_AND_OTHER_COSTS_
RESTRUCTURING AND OTHER COSTS (Detail Textuals) (USD $) | 0 Months Ended | 1 Months Ended | 3 Months Ended | 9 Months Ended | |
In Thousands, unless otherwise specified | Aug. 04, 2014 | Jul. 31, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 |
Employee | Employee | ||||
Restructuring Cost and Reserve [Line Items] | ' | ' | ' | ' | ' |
Number of position reduced | ' | 26 | ' | ' | ' |
Number of employee before restructuring | 62 | ' | ' | ' | ' |
Number of employee remained after implementation of restructuring | 40 | 68 | ' | ' | ' |
Amount paid for restructuring | ' | ' | $234 | $403 | ' |
Impairment of property and equipment | ' | ' | ' | ' | 280 |
Severance payments | ' | ' | ' | ' | ' |
Restructuring Cost and Reserve [Line Items] | ' | ' | ' | ' | ' |
Expected restructuring cost | 662 | 434 | ' | ' | ' |
Benefits continuation costs | ' | ' | ' | ' | ' |
Restructuring Cost and Reserve [Line Items] | ' | ' | ' | ' | ' |
Expected restructuring cost | 74 | 94 | ' | ' | ' |
Modification of employee stock options | ' | ' | ' | ' | ' |
Restructuring Cost and Reserve [Line Items] | ' | ' | ' | ' | ' |
Expected restructuring cost | ' | ' | $83 | $139 | $83 |