- 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
- 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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