- Phase 3 Trial of Niraparib in Breast Cancer to be Initiated in the Second Half of 2013
- Phase 3 Trial of Niraparib in Ovarian Cancer on Track to Begin Enrolling Mid-2013
- Top-Line Results of Rolapitant Phase 3 Program to be Announced in the Second Half of 2013
- Fifth Dose Level Achieved in Phase 1/2 Clinical Trial of TSR-011
- Net Cash Position Totaled Approximately $199 Million as of March 31, 2013
WALTHAM, Mass., April 25, 2013 (GLOBE NEWSWIRE) -- TESARO, Inc. (Nasdaq:TSRO), an oncology-focused biopharmaceutical company, today reported financial results for the first quarter of 2013.
"TESARO continues to make significant progress in advancing its oncology portfolio. With the completion of our follow-on public offering of common stock in March, we are very well positioned to support and expand our clinical development initiatives. Today, we are pleased to announce that we intend to initiate a Phase 3 trial of niraparib in patients with breast cancer during the second half of 2013 to complement our ovarian pivotal program," said Lonnie Moulder, chief executive officer of TESARO. "We look forward to the presentation of the final Phase 1/2 results for niraparib at the upcoming American Society for Clinical Oncology (ASCO) Annual Meeting and data supporting a reduced potential of drug interactions for rolapitant at the Multinational Association of Supportive Care in Cancer (MASCC) symposium."
- Following a meeting with the U.S. Food and Drug Administration (FDA), planning is now underway for the initiation of a Phase 3 trial of niraparib, an orally active, potent PARP (poly (ADP-ribose) polymerase) inhibitor, in breast cancer patients with germline BRCA mutations.
- Clinical site selection is ongoing to support the start of enrollment for a Phase 3 pivotal study of niraparib by mid-year in patients with high grade serous, platinum-sensitive ovarian cancer, including those with germline BRCA mutations.
- Enrollment continues in each of three Phase 3 trials of rolapitant for the prevention of chemotherapy induced nausea and vomiting (CINV). This global program is currently being conducted at more than 200 clinical trial sites across 25 countries.
- The fifth dosing cohort has been reached in a Phase 1/2 study of TSR-011, an orally available anaplastic lymphoma kinase (ALK) inhibitor. TESARO plans to evaluate TSR-011 in three parallel cohorts of patients: those with ALK-positive non-small cell lung cancer (NSCLC) who have not been previously treated with an ALK inhibitor, those with ALK-positive NSCLC who have progressed during treatment with an ALK inhibitor, and those patients with other tumor types that express ALK.
- A follow-on public offering of 5,428,000 shares of TESARO common stock closed in March and generated aggregate net proceeds of approximately $91.3 million to the Company after underwriting discounts, commissions and other estimated offering expenses.
- TESARO reported a net loss of $18.9 million, or $0.66 per share, for the first quarter of 2013, compared to a net loss of $9.3 million, or $13.59 per share, for the first quarter of 2012.
- Research and development expenses increased to $16.5 million for the first quarter of 2013, compared to $8.2 million for the first quarter of 2012, driven primarily by expanded development activities for rolapitant and niraparib and increased clinical costs for TSR-011.
- General and administrative expenses increased to $2.4 million for the first quarter of 2013, compared to $1.2 million for the comparable period in the previous year, primarily as a result of increases in both personnel costs and professional fees.
- Operating expenses as described above include stock-based compensation expense of $0.8 million for the first quarter of 2013, compared to $0.2 million for the first quarter of 2012.
- As of March 31, 2013, TESARO had $198.6 million in cash and cash equivalents, no debt and 32.6 million outstanding shares of common stock.
- Announce top-line results for the Phase 3 program evaluating oral rolapitant for the prevention of CINV in the second half of 2013;
- Advance the clinical development of rolapitant intravenous (IV) formulation in order to support a future submission for registration concurrent with the approval of the oral formulation;
- Begin enrollment of the Phase 3 trial of niraparib as a potential maintenance therapy for ovarian cancer patients by mid-2013;
- Initiate a Phase 3 trial of niraparib in breast cancer patients with germline BRCA mutations in the second half of 2013; and
- Advance the TSR-011 development program and define a strategy for the next phase of clinical development.
|Unaudited Condensed Consolidated Statements of Operations|
|(in thousands, except per share amounts)|
|Three Months Ended March 31,|
|Research and development||$ 8,150||$ 16,503|
|General and administrative||1,199||2,400|
|Loss from operations||(9,349)||(18,903)|
|Net loss||$ (9,329)||$ (18,869)|
|Net loss per share applicable to common stockholders - basic and diluted||$ (13.59)||$ (0.66)|
|Weighted-average number of common shares used in net loss per share applicable to common stockholders - basic and diluted||687||28,798|
|Unaudited Condensed Consolidated Balance Sheets|
|December 31, 2012||March 31, 2013|
|Cash and cash equivalents||$ 125,445||$ 198,644|
|Other current assets||1,175||889|
|Total current assets||126,620||199,533|
|Property and equipment, net||219||490|
|Total assets||$ 127,380||$ 200,556|
|Liabilities, convertible preferred stock and stockholders' equity|
|Accounts payable||$ 3,170||$ 2,105|
|Other current liabilities||3||13|
|Total current liabilities||11,718||11,619|
|Other non-current liabilities||--||13|
|Commitments and contingencies|
|Total stockholders' equity||115,662||188,924|
|Total liabilities, convertible preferred stock and stockholders' equity||$ 127,380||$ 200,556|
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