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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Juno Therapeutics, Inc. (delisted) | NASDAQ:JUNO | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 86.96 | 77.15 | 87.00 | 0 | 01:00:00 |
– Strong cash position of $1.04 billion –
– JCAR015 Phase II ROCKET trial continues enrollment –
– JCAR015 U.S. approval projected as early as the first half of 2018 –
– Data to be presented at ASH, including Phase I JCAR017 NHL data –
– Eight product candidates in clinical trials against six different targets –
– Juno reaffirms cash burn guidance –
– Conference call today at 5:00p.m. Eastern Time –
Juno Therapeutics, Inc. (NASDAQ: JUNO), a biopharmaceutical company focused on re-engaging the body’s immune system to revolutionize the treatment of cancer, today reported financial results and business highlights for the third quarter 2016.
“JCAR017, a key product candidate of our CD19 platform, has shown encouraging preliminary efficacy and safety results in NHL and pediatric ALL. At the upcoming American Society of Hematology meeting, additional data from our Phase I trial for JCAR017 in NHL patients will be presented,” said Hans Bishop, Juno’s President and Chief Executive Officer. “Progress with CAR T therapy continues as we strive to bring these innovative product candidates to patients battling cancer. We look forward to the upcoming presentations at ASH, including 11 total presentations from a number of ongoing and completed studies.”
Third Quarter 2016 and Recent Corporate Highlights
Clinical Update:
Corporate Development News:
Third Quarter 2016 Financial Results
A reconciliation of GAAP net loss to non-GAAP net loss is presented below under “Non-GAAP Financial Measures.”
2016 Financial Guidance Reaffirmed
Juno reaffirms 2016 cash burn guidance, excluding cash inflows or outflows from upfront payments related to business development activities, of between $220 million and $250 million.
Conference Call Information
Juno will host a conference call today to review Juno’s financial results for the third quarter 2016 beginning at 2:00 p.m. Pacific Time (PT)/5:00 p.m. Eastern Time (ET). Analysts and investors can participate in the conference call by dialing (855) 780-7198 for domestic callers and (631) 485-4870 for international callers, using the conference ID# 7555725.
The webcast can be accessed live on the Investor Relations page of Juno's website, www.JunoTherapeutics.com, and will be available for replay for 30 days following the call.
About Juno
Juno Therapeutics is building a fully integrated biopharmaceutical company focused on re-engaging the body’s immune system to revolutionize the treatment of cancer. Founded on the vision that the use of human cells as therapeutic entities will drive one of the next important phases in medicine, Juno is developing cell-based cancer immunotherapies based on chimeric antigen receptor and high-affinity T cell receptor technologies to genetically engineer T cells to recognize and kill cancer. Juno is developing multiple cell-based product candidates to treat a variety of B-cell malignancies as well as solid tumors. Several product candidates have shown compelling clinical responses in clinical trials in refractory leukemia and lymphoma conducted to date. Juno's long-term aim is to leverage its cell-based platform to develop new product candidates that address a broader range of cancers and human diseases. Juno brings together innovative technologies from some of the world's leading research institutions, including the Fred Hutchinson Cancer Research Center, Memorial Sloan Kettering Cancer Center, Seattle Children's Research Institute, the University of California, San Francisco, and The National Cancer Institute. Juno Therapeutics has an exclusive license to the St. Jude Children’s Research Hospital patented technology for CD19-directed product candidates that use 4-1BB, which was developed by Dario Campana, Chihaya Imai, and St. Jude Children’s Research Hospital.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934, including statements regarding Juno’s mission, progress, and business plans; clinical benefits; clinical trial results and the implications thereof; clinical trial plans and regulatory approval timelines; planned data presentations at the ASH Annual Meeting; the potential of acquired or licensed technology and capabilities; and 2016 cash burn forecast. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from such forward-looking statements, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to, risks associated with: the success, cost, and timing of Juno's product development activities and clinical trials; Juno's ability to obtain regulatory approval for and to commercialize its product candidates; Juno's ability to establish a commercially-viable manufacturing process and manufacturing infrastructure; regulatory requirements and regulatory developments; success of Juno's competitors with respect to competing treatments and technologies; Juno's dependence on third-party collaborators and other contractors in Juno's research and development activities, including for the conduct of clinical trials and the manufacture of Juno's product candidates; Juno's dependence on Celgene for the development and commercialization outside of North America and China of Juno’s CD19 product candidates and any other product candidates for which Celgene exercises an option; Juno’s dependence on JW Therapeutics (Shanghai) Co., Ltd, over which Juno does not exercise complete control, for the development and commercialization of product candidates in China; Juno's ability to obtain, maintain, or protect intellectual property rights related to its product candidates; amongst others. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Juno's business in general, see Juno's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 5, 2016 and Juno’s other periodic reports filed with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. Juno disclaims any obligation to update these forward-looking statements.
Juno Therapeutics, Inc. Condensed Consolidated Balance Sheets (Unaudited) (In thousands) September 30, 2016 December 31, 2015 ASSETS Current assets: Cash, cash equivalents, and short-term marketable securities $ 820,656 $ 943,411 Accounts receivable 10,603 315 Prepaid expenses and other current assets 13,514 8,113 Total current assets 844,773 951,839 Property and equipment, net 57,708 42,086 Long-term marketable securities 214,880 272,888 Goodwill 221,306 122,092 Intangible assets 80,135 50,177 Other assets 7,495 6,046 Total assets $ 1,426,297 $ 1,445,128 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable and accrued liabilities $ 47,855 $ 37,624 Success payment liabilities 34,502 64,829 Contingent consideration 9,271 1,905 Deferred revenue 41,403 15,370 Total current liabilities 133,031 119,728 Build-to-suit lease obligation, less current portion 8,758 9,294 Contingent consideration, less current portion 22,820 35,361 Deferred revenue, less current portion 129,969 129,831 Deferred tax liabilities 7,351 8,946 Other long-term liabilities 7,431 435 Stockholders' equity: Common stock 10 10 Additional paid-in capital 1,895,825 1,733,263 Accumulated other comprehensive loss (439 ) (6,083 ) Accumulated deficit (778,459 ) (585,657 ) Total stockholders' equity 1,116,937 1,141,533 Total liabilities and stockholders' equity $ 1,426,297 $ 1,445,128 Juno Therapeutics, Inc. Condensed Consolidated Statements of Operations (Unaudited) (In thousands, except share and per share data) Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Revenue $ 20,826 $ 1,602 $ 58,203 $ 14,063 Operating expenses: Research and development 60,854 11,503 206,887 129,537 General and administrative 18,441 13,632 51,210 41,184 Total operating expenses 79,295 25,135 258,097 170,721 Loss from operations (58,469 ) (23,533 ) (199,894 ) (156,658 ) Other-than-temporary impairment loss - - (5,490 ) - Interest income, net 1,485 356 4,322 709 Other income (expenses), net (507 ) - (871 ) 233 Loss before income taxes (57,491 ) (23,177 ) (201,933 ) (155,716 ) Benefit from (provision for) income taxes 594 (63 ) 9,131 1,553 Net loss $ (56,897 ) $ (23,240 ) $ (192,802 ) $ (154,163 ) Net loss per share, basic and diluted $ (0.56 ) $ (0.26 ) $ (1.91 ) $ (1.80 ) Weighted average common shares outstanding, basic and diluted 102,177,808 90,827,026 100,961,382 85,702,518Non-GAAP Financial Measures
To supplement the financial results presented in accordance with generally accepted accounting principles in the United States (GAAP), Juno uses certain non-GAAP financial measures to evaluate its business. Juno’s management believes that these non-GAAP financial measures are helpful in understanding Juno’s financial performance and potential future results. These are not meant to be considered in isolation or as a substitute for comparable GAAP measures and should be read in conjunction with Juno’s financial statements prepared in accordance with GAAP. These non-GAAP measures differ from GAAP measures with the same captions, may be different from non-GAAP financial measures with the same or similar captions that are used by other companies, and do not reflect a comprehensive system of accounting. Juno’s management uses these supplemental non-GAAP financial measures internally to understand, manage, and evaluate Juno’s business and make operating decisions. In addition, Juno’s management believes that the presentation of these non-GAAP financial measures is useful to investors because they enhance the ability of investors to compare Juno’s results from period to period and allows for greater transparency with respect to key financial metrics Juno uses in making operating decisions. Juno endeavors to compensate for the limitation of the non-GAAP measures presented by also providing the most directly comparable GAAP measures and descriptions of the reconciling items and adjustments to derive the non-GAAP measures. The following is a reconciliation of GAAP to non-GAAP financial measures:
Juno Therapeutics, Inc. Reconciliation of GAAP to Non-GAAP Net Loss (Unaudited) (In thousands, except share and per share data) Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Net loss - GAAP $ (56,897 ) $ (23,240 ) $ (192,802 ) $ (154,163 ) Adjustments: Success payment (gain) expense (1) (17,650 ) (25,586 ) (20,758 ) 17,285 Non-cash stock-based compensation expense (2) 938 1,271 3,329 4,834 Change in fair value of contingent consideration (3) 336 1,283 (5,175 ) 1,203 Upfront payments related to the acquisition of technology (4) 15,000 - 15,000 30,810 Net loss - Non-GAAP $ (58,273 ) $ (46,272 ) $ (200,406 ) $ (100,031 ) Net loss per share - GAAP $ (0.56 ) $ (0.26 ) $ (1.91 ) $ (1.80 ) Adjustments: Success payment (gain) expense (1) (0.17 ) (0.28 ) (0.21 ) 0.20 Non-cash stock-based compensation expense (2) 0.01 0.01 0.03 0.06 Change in fair value of contingent consideration (3) - 0.01 (0.05 ) 0.01 Upfront payments related to the acquisition of technology (4) 0.15 - 0.15 0.36 Net loss per share, basic and diluted - Non-GAAP $ (0.57 ) $ (0.52 ) $ (1.99 ) $ (1.17 ) Weighted average common shares outstanding, basic and diluted 102,177,808 90,827,026 100,961,382 85,702,518 Juno Therapeutics, Inc. Reconciliation of GAAP to Non-GAAP Research and Development Expenses (Unaudited) (In thousands) Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Research and development expense - GAAP $ (60,854 ) $ (11,503 ) $ (206,887 ) $ (129,537 ) Adjustments: Success payment (gain) expense (1) (17,650 ) (25,586 ) (20,758 ) 17,285 Non-cash stock-based compensation expense (2) 938 1,271 3,329 4,834 Change in fair value of contingent consideration (3) 336 1,283 (5,175 ) 1,203 Upfront payments related to the acquisition of technology (4) 15,000 - 15,000 30,810 Research and development expense - Non-GAAP $ (62,230 ) $ (34,535 ) $ (214,491 ) $ (75,405 )(1) The success payment expense (gain) represents the change in the estimated fair value of the success payment obligations and the associated elapsed service period. As of September 30, 2016, the estimated fair values of the success payment liabilities to FHCRC and MSK on the condensed consolidated balance sheets, after giving effect to the success payments achieved in December 2015, were approximately $20.5 million and $14.0 million, respectively. In December 2015, success payments of $75.0 million, less indirect costs of $3.3 million, and $10.0 million, less indirect costs of $1.0 million, were triggered to FHCRC and MSK, respectively. Juno elected to make the payments in shares of its common stock and thereby issued 1,601,085 shares to FHCRC in December 2015 and 240,381 shares to MSK in March 2016. In April 2016, Juno repurchased from MSK the 240,381 shares of common stock that had been issued to MSK. If success payment thresholds are met in the future, Juno may pay FHCRC and MSK the applicable success payment in cash or publicly-traded equity at Juno’s election. The success payment liabilities are subject to re-measurement each reporting period and may fluctuate from quarter-to-quarter and year-to-year, sometimes significantly, resulting in either an expense or a gain depending on the trading price of Juno common stock, estimated term, expected volatility, risk-free interest rate, estimated number and timing of valuation measurement dates, and estimated indirect costs that are creditable against the success payments to FHCRC and MSK.
(2) This relates to a restricted stock grant in 2013 to a former co-founding director who became a consultant upon his departure from Juno’s board of directors in 2014. Unlike other outstanding awards to Juno’s employees, scientific founders, and continuing directors, the value of this restricted stock award is subject to re-measurement each reporting period as the award vests and may result in the associated expense fluctuating from quarter-to-quarter and year-to-year, sometimes significantly, based on changes in the trading price of Juno common stock through the end of the vesting period.
(3) This is the change in the estimated fair value of the contingent consideration liabilities recorded in connection with the Stage and X-Body acquisitions.
(4) The upfront payments related to the acquisition of technology in 2016 include payments made in connection with technology licensing and the acquisition of RedoxTherapies. The upfront payments related to the acquisition of technology in 2015 include payments in connection with the Editas and Fate Therapeutics collaborations.
View source version on businesswire.com: http://www.businesswire.com/news/home/20161109006265/en/
Juno TherapeuticsInvestor Relations:Nicole Keith, 206-566-5521nikki.keith@junotherapeutics.comorMedia:Christopher Williams, 206-566-5660chris.williams@junotherapeutics.com
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