On October 29, 2015 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported operating results for third-quarter 2015 and provided an update on the Company’s development programs (Press release, TESARO, OCT 29, 2015, View Source [SID:1234507845]).
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"The FDA approval of TESARO’s first product, VARUBI, offers a new treatment option for patients with cancer who are affected by nausea and vomiting caused by chemotherapy and represents a significant milestone for TESARO," said Lonnie Moulder, CEO of TESARO. "Our field organization is fully in place, and we look forward to providing VARUBI to patients in mid-November. In addition to VARUBI, we are building a franchise around niraparib in ovarian cancer, and we are enthusiastic about the potential to expand our development program for this molecule to include several new tumor types. The Phase 3 NOVA trial of niraparib was initiated more than two years ago, and patient enrollment completed seven months ago. Based upon a recently completed HRD assessment of tumor samples and a greater than anticipated duration of treatment, we now look forward to top-line data from NOVA in the second quarter of 2016. We are very optimistic about the potential of niraparib for patients with ovarian, breast and other cancers."
Recent Business Highlights
On September 1, 2015, the U.S. Food and Drug Administration (FDA) approved VARUBI (oral rolapitant), in combination with other antiemetic agents in adults, for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.
The National Comprehensive Cancer Network (NCCN) added VARUBI to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) Antiemesis Version 2.2015 as a recommended option, in combination with other antiemetic agents, for patients receiving both high emetic risk intravenous chemotherapy (HEC) and moderate emetic risk intravenous chemotherapy (MEC). Category 1, the highest level category of evidence and consensus, was granted to rolapitant for both HEC and MEC chemotherapy.
The TESARO field organization is now over 120 associates strong and includes sales management, area managers, corporate account directors, medical science liaisons, and clinical nurse educators. Preparation is ongoing to support the successful U.S. commercial launch of VARUBI in mid-November.
The planned intravenous (IV) rolapitant clinical program is now complete, and following a pre-NDA meeting with the U.S. FDA, a New Drug Application (NDA) will be submitted.
An assessment of the patient tumor samples collected from patients enrolled in the Phase 3 NOVA trial of niraparib was recently completed using the myChoice HRD test in preparation for progression-free survival (PFS) endpoint analysis. As anticipated, results from this testing determined that approximately 50% of patients enrolled in the non-gBRCA cohort have HRD-positive tumors.
Based on the observed event rate, new estimates for the NOVA timing of PFS events indicate that top-line PFS results for NOVA are now expected to be available in Q2 2016.
Enrollment of the QUADRA trial of niraparib for the treatment of patients with ovarian cancer who have received three or more prior lines of chemotherapy is now more than 50 percent complete.
Antibody drug candidates targeting PD-1, TIM-3, and LAG-3 continue to advance, and Investigational New Drug (IND) application preparations are underway for TSR-042 and TSR-022, our anti-PD-1 and anti-TIM-3 antibody candidates.
The Phase 1/2 clinical trial of TSR-011 has been discontinued, and resources are being reprioritized to support development programs for niraparib and our immuno-oncology candidates.
Third Quarter 2015 Financial Results
TESARO reported a net loss of $66.6 million, or ($1.66) per share, for the third quarter of 2015, compared to a net loss of $36.2 million, or ($1.01) per share, for the third quarter of 2014.
Research and development expenses increased to $40.1 million for the third quarter of 2015, compared to $29.9 million for the third quarter of 2014, driven primarily by higher costs related to expanded development activities and increased headcount.
Selling, general, and administrative expenses increased to $22.8 million for the third quarter of 2015, compared to $6.3 million for the third quarter of 2014, primarily due to pre-launch commercial activities in support of VARUBI, increased commercial headcount, and higher professional service fees.
Operating expenses, as described above, include total non-cash, stock-based compensation expense of $8.1 million for the third quarter of 2015, compared to $2.9 million for the third quarter of 2014.
As of September 30, 2015, TESARO had approximately $302.5 million in cash and cash equivalents and approximately 40.0 million outstanding shares of common stock. TESARO expects cash utilization to be in the mid- to high-$50 million range for the fourth quarter of 2015, excluding a $15 million milestone payment that will be due upon the first commercial sale of VARUBI, which is expected to occur in November.
Corporate Objectives
TESARO anticipates achieving the following key objectives:
Launch VARUBI into the U.S. market in mid-November 2015;
Submit the NDA for IV rolapitant in Q1 2016;
Submit the oral rolapitant Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in Q2 2016;
Report top-line data from the Phase 3 NOVA trial of niraparib in Q2 2016;
Report top-line data from the QUADRA trial of niraparib in Q2 2016;
Submit the niraparib NDA in 2H 2016;
Continue to enroll the Phase 3 BRAVO trial of niraparib in breast cancer patients with germline BRCA mutations through 2016;
Initiate enrollment in the niraparib/KEYTRUDA (pembrolizumab) combination trial in Q1 2016;
Initiate enrollment in the Phase 3 clinical trial of niraparib in first line ovarian cancer (PRIMA) in Q1 2016;
Advance the development of TSR-042 (anti-PD-1 antibody) to support submission of an IND application to the U.S. FDA at year-end 2015; and
Advance the IND-enabling studies for TSR-022 (anti-TIM-3 clinical candidate) to support submission of an IND application in Q2 2016.