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WALTHAM, Mass., Aug. 6, 2015 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today reported operating results for second-quarter 2015 and provided an update on the Company's development programs.
"TESARO continues to make significant progress in advancing its pipeline of product candidates, and preparations for the commercial launch of oral rolapitant are well underway to support product introduction in the fourth quarter," said Lonnie Moulder, CEO of TESARO. "We have established our medical science liaison, nurse educator, and regional sales leadership teams, and the build-out of our field sales organization is nearly complete. The second half of 2015 will be an exciting time for the Company, as we look ahead to the expected niraparib Phase 3 NOVA trial data in the fourth quarter of 2015, the NDA submission for IV rolapitant, and the initiation of our immuno-oncology clinical program in early 2016."
Recent Business Highlights
Second-Quarter 2015 Financial Results
TESARO anticipates achieving the following key objectives:
Today's Conference Call and Webcast
TESARO will host a conference call to discuss the Company's second quarter operating results and provide an update on the Company's development programs today at 4:15 P.M. Eastern time. The accompanying slide presentation and live webcast of the conference call can be accessed by visiting the TESARO website at www.tesarobio.com. The call can be accessed by dialing (877) 853-5334 (U.S. and Canada) or (970) 315-0307 (international). A replay of the webcast will be archived on the Company's website for 30 days following the call.
TESARO is an oncology-focused biopharmaceutical company dedicated to improving the lives of cancer patients by acquiring, developing, and commercializing safer and more effective therapeutics. For more information, visit www.tesarobio.com.
Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding TESARO, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. Examples of forward-looking statements contained in this press release include, among others, statements regarding our expected range of cash utilization for the remainder of 2015, our expectation to have Phase 3 NOVA data in the fourth quarter of 2015 and QUADRA data in early 2016, the expected timing of the rolapitant MAA filing, the NDA for rolapitant IV, and other regulatory filings with respect to our product candidates, the expected timing of the rolapitant commercial launch, the expected timing of data from our various clinical trials, our plans regarding future clinical trials with niraparib, statements regarding our various 2015 corporate objectives, the estimated time periods when we expect clinical trials to commence or be completed, and statements regarding our expectations about the timing of both the selection of clinical candidates from our immuno-oncology programs and the commencement of clinical testing for those candidates. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our research and pre-clinical development programs, clinical development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the execution and completion of clinical trials, uncertainties surrounding the timing of availability of data from our clinical trials, ongoing discussions with and actions by regulatory authorities, patient accrual rates for clinical trials, and other matters that could affect the timing of availability of data from or initiation of our clinical trials, uncertainties regarding regulatory approvals, uncertainties regarding certain expenditures, and other matters that could affect the availability or commercial potential of our drug candidates. TESARO undertakes no obligation to update or revise any forward-looking statements. 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 the business of the Company in general, see TESARO's Annual Report on Form 10-K for the year ended December 31, 2014.
|Unaudited Condensed Consolidated Statements of Operations|
|(in thousands, except per share amounts)|
Three Months Ended
Six Months Ended
|Research and development (1)||$ 30,569||$ 38,930||$ 58,686||$ 72,475|
|General and administrative (1)||5,587||16,783||10,275||28,025|
|Acquired in-process research and development||900||1,000||17,900||1,000|
|Loss from operations||(37,056)||(56,713)||(86,861)||(101,500)|
|Interest income (expense), net||5||(3,844)||10||(7,563)|
|Net loss||$ (37,051)||$ (60,557)||$ (86,851)||$ (109,063)|
|Net loss per share applicable to common stockholders - basic and diluted||$ (1.03)||$ (1.51)||$ (2.45)||$ (2.82)|
Weighted-average number of common shares used in net loss per share applicable
to common stockholders - basic and diluted
|(1) Expenses include the following amounts of non-cash stock-based compensation expense:|
|Research and development||$ 1,454||$ 2,211||$ 2,364||$ 4,025|
|General and administrative||1,648||3,249||3,276||5,356|
|Unaudited Condensed Consolidated Balance Sheets|
|Cash and cash equivalents||$ 256,861||$ 354,369|
|Other current assets||1,735||2,871|
|Total current assets||258,596||357,240|
|Property and equipment, net||1,022||2,177|
|Total assets||$ 263,902||$ 363,377|
|Liabilities and stockholders' equity|
|Accounts payable||$ 6,089||$ 9,623|
|Other current liabilities||1,526||1,559|
|Total current liabilities||24,365||35,973|
|Convertible notes, net||115,481||119,685|
|Total stockholders' equity||124,056||207,719|
|Total liabilities and stockholders' equity||$ 263,902||$ 363,377|
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