- Niraparib to be Advanced in a Phase 3 Pivotal Trial for Ovarian Cancer
- Enrollment Continues in the Global Registration Program for Rolapitant
- Achieved Third Dose-level in a Phase 1/2 Clinical Trial of TSR-011
- The Company has met with the FDA and finalized its clinical development program for niraparib, an orally active and potent PARP (poly (ADP-ribose) polymerase) inhibitor, in the ovarian cancer setting. TESARO will initiate a pivotal Phase 3 randomized double-blind, international trial to evaluate the potential benefit of niraparib compared to a placebo on the maintenance of response following completion of a platinum containing chemotherapy regimen. The study will separately evaluate the benefit of niraparib in two groups of ovarian cancer patients, those with and without certain deficiencies in DNA repair. The rationale for this study includes robust Phase 1 and 2 data showing a high response rate in patients with ovarian cancer who are treated with PARP inhibitors, compelling Phase 1 data from the dose escalation and expansion clinical study of niraparib, as well as the results of a study with a comparable design in the ovarian cancer maintenance setting that showed a strong progression free survival, or PFS, benefit for patients receiving another investigational PARP inhibitor. The Company expects to initiate this Phase 3 clinical trial by mid-year.
- The Company initiated the rolapitant global registration program in early 2012 and is continuing to enroll cancer patients in each of three phase 3 clinical trials. This global registration program evaluating rolapitant for the prevention of chemotherapy induced nausea and vomiting (CINV) is currently being conducted at more than 200 clinical trial sites located in 25 countries. TESARO intends to announce topline results for the three Phase 3 pivotal trials in the second half of 2013.
- Following clearance in late September of the Investigational New Drug (IND) application for TSR-011, an orally available anaplastic lymphoma kinase (ALK) inhibitor (targeted anti-cancer agent) by the FDA, the first cancer patient was enrolled in a Phase 1/2 clinical study. The third dosing cohort in the dose escalation phase of the study was initiated in January of 2013. Once the maximum tolerated dose of TSR-011 is identified, the Company 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.
- TESARO reported a net loss of $18.7 million for the fourth quarter of 2012 and $61.8 million for the year ended December 31, 2012. This compares to a net loss of $9.1 million and $16.4 million for the fourth quarter and year ended December 31, 2011, respectively. Net loss attributable to common stockholders for the fourth quarter of 2012 was $0.70 per share, compared to $15.41 per share for the fourth quarter of 2011. Net loss attributable to common stockholders for the year ended December 31, 2012 was $4.51 per share, compared to $31.90 per share for the year ended December 31, 2011.
- Research and development expenses totaled $15.6 million for the fourth quarter of 2012 and $47.2 million for the full year 2012, compared to $8.0 million for the fourth quarter of 2011 and $11.8 million for the full year 2011. Research and development expenses increased from 2011 primarily due to the expanded development activities for rolapitant and TSR-011 as well as the in-licensing of niraparib in mid-2012.
- The Company recorded $8.0 million of acquired in-process research and development expense in 2012, $7.0 million of which related to the in-licensing of niraparib and $1.0 million related to a fourth quarter development milestone payment with respect to TSR-011.
- General and administrative expenses totaled $2.1 million for the fourth quarter of 2012 and $6.7 million for the full year 2012, compared to $1.1 million and $3.2 million for the comparable periods in the previous year. The increase in general and administrative expenses was primarily due to increased personnel and professional fees.
- Operating expenses as described above include stock-based compensation expense of $1.8 million for the full year 2012, compared to $0.3 million for the full year 2011.
- As of December 31, 2012, TESARO had $125.4 million in cash and cash equivalents, no debt and 27.1 million outstanding shares of common stock.
- Announce topline results for the three Phase 3 pivotal trials evaluating oral rolapitant for the prevention of CINV.
- Advance the clinical development of rolapitant intravenous (IV) formulation in order to support a future submission for registration concurrent with the approval of the oral formulation.
- Begin enrollment of the Phase 3 pivotal trial of niraparib as a potential maintenance therapy for ovarian cancer patients.
- Advance the TSR-011 development program and define a strategy for the next phase of clinical development.
|Unaudited Condensed Consolidated Statements of Operations|
|(in thousands, except per share amounts)|
|Three Months Ended December 31,||Years Ended December 31,|
|Research and development||$ 8,001||$ 15,642||$ 11,768||$ 47,200|
|General and administrative||1,090||2,095||3,158||6,715|
|Acquired in-process research and development||--||1,000||500||8,000|
|Loss from operations||(9,091)||(18,737)||(15,426)||(61,915)|
|Net loss||$ (9,078)||$ (18,697)||$ (16,398)||$ (61,763)|
|Net loss per share applicable to common stockholders - basic and diluted||$ (15.41)||$ (0.70)||$ (31.90)||$ (4.51)|
|Weighted-average number of common shares used in net loss per share applicable to common stockholders - basic and diluted||589||26,740||514||13,696|
|Unaudited Condensed Consolidated Balance Sheets|
|December 31, 2011||December 31, 2012|
|Cash and cash equivalents||$ 39,825||$ 125,445|
|Other current assets||2,606||1,175|
|Total current assets||42,431||126,620|
|Property and equipment, net||118||219|
|Total assets||$ 42,879||$ 127,380|
|Liabilities, convertible preferred stock and stockholders' (deficit) equity|
|Accounts payable||$ 605||$ 3,170|
|Other current liabilities||11||3|
|Total current liabilities||3,596||11,718|
|Other non-current liabilities||3||--|
|Commitments and contingencies|
|Convertible preferred stock||64,348||--|
|Total stockholders' (deficit) equity||(25,068)||115,662|
|Total liabilities, convertible preferred stock and stockholders' (deficit) equity||$ 42,879||$ 127,380|
CONTACT: Richard Rodgers Executive Vice President & CFO +1.339.970.0903 firstname.lastname@example.org