- Top-Line Results from Rolapitant Phase 3 Program to be Announced by Year-End 2013
- Patient Enrollment Ongoing in Phase 3 Trial of Niraparib in Ovarian Cancer
- Phase 3 Trial of Niraparib in Breast Cancer On Track to Begin 2H 2013
- First TSR-011 Clinical Data Accepted for Presentation at ESMO
- Cash and Cash Equivalents Totaled $178 Million as of June 30, 2013
- Enrollment continues in each of three Phase 3 trials of rolapitant for the prevention of chemotherapy induced nausea and vomiting (CINV). TESARO anticipates that top-line data from this pivotal program will be announced by year end.
- Results from a pharmacokinetic study of rolapitant were presented at the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) International Symposium in Berlin. These data support concomitant administration of rolapitant with other pharmaceutical products that are metabolized by the liver microsomal enzyme CYP3A4, without a requirement for dose adjustment of the co-administered product.
- TESARO's Phase 3 pivotal study of niraparib in patients with high grade serous, platinum-sensitive ovarian cancer, including those with germline BRCA mutations, has begun patient enrollment.
- Clinical site selection is ongoing to support the initiation of a Phase 3 pivotal study of niraparib in breast cancer patients with germline BRCA mutations during the second half of 2013.
- Final Phase 1 results for niraparib were presented at the American Society of Clinical Oncology (ASCO) annual meeting. Data demonstrated a favorable benefit/risk profile and durable responses among heavily pretreated patients with breast and ovarian cancer.
- An abstract describing initial clinical data for TSR-011 has been accepted for poster presentation at the European Society for Medical Oncology (ESMO) Congress in September.
- TESARO reported a net loss of $21.6 million, or $0.67 per share, for the second quarter of 2013, compared to a net loss of $20.2 million, or $21.31 per share, for the second quarter of 2012. The Company's second-quarter 2012 net loss included $7.0 million of acquired in-process R&D expense related to the in-license of niraparib.
- Research and development expenses increased to $18.2 million for the second quarter of 2013, compared to $11.5 million for the second quarter of 2012, driven primarily by expanded activities for our ongoing development programs.
- General and administrative expenses increased to $3.4 million for the second quarter of 2013, compared to $1.7 million for the comparable period in the previous year, primarily as a result of increases in non-cash stock-based compensation and other general and administrative personnel costs.
- Operating expenses as described above include non-cash stock-based compensation expense of $1.6 million for the second quarter of 2013, compared to $0.4 million for the second quarter of 2012.
- As of June 30, 2013, TESARO had $178.1 million in cash and cash equivalents, no debt and 32.6 million outstanding shares of common stock.
- Announce top-line results from the Phase 3 program evaluating oral rolapitant for the prevention of CINV by the end of 2013;
- Advance the clinical development of the rolapitant intravenous (IV) formulation in order to support a future submission for registration concurrent with regulatory approval of the oral formulation;
- Continue enrollment of the Phase 3 trial of niraparib as a potential maintenance therapy for patients with ovarian cancer;
- Initiate a Phase 3 trial of niraparib in breast cancer patients with germline BRCA mutations; and
- Finalize the recommended Phase 2 dose for TSR-011 and initiate Phase 2a expansion cohorts.
|Unaudited Condensed Consolidated Statements of Operations|
|(in thousands, except per share amounts)|
|Three Months Ended June 30,||Six Months Ended June 30,|
|Research and development||$11,532||$18,177||$19,682||$34,680|
|General and administrative||1,685||3,412||2,884||5,812|
|Acquired in-process research and development||7,000||--||7,000||--|
|Loss from operations||(20,217)||(21,589)||(29,566)||(40,492)|
|Net loss||$ (20,178)||$ (21,564)||$ (29,507)||$ (40,433)|
|Net loss per share applicable to common stockholders - basic and diluted||$ (21.31)||$ (0.67)||$ (36.11)||$ (1.32)|
|Weighted-average number of common shares used in net loss per share applicable to common stockholders - basic and diluted||947||32,336||817||30,577|
|Unaudited Condensed Consolidated Balance Sheets|
|December 31, 2012||June 30, 2013|
|Cash and cash equivalents||$ 125,445||$ 178,091|
|Other current assets||1,175||1,564|
|Total current assets||126,620||179,655|
|Property and equipment, net||219||504|
|Total assets||$ 127,380||$ 181,022|
|Liabilities and stockholders' equity|
|Accounts payable||$ 3,170||$ 1,964|
|Other current liabilities||3||13|
|Total current liabilities||11,718||11,954|
|Other non-current liabilities||--||9|
|Commitments and contingencies|
|Total stockholders' equity||115,662||169,059|
|Total liabilities and stockholders' equity||$ 127,380||$ 181,022|
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