On May 05, 2016 (GLOBE NEWSWIRE) TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported operating results for first quarter 2016 and provided an update on the Company’s development programs (Press release, TESARO, MAY 5, 2016, View Source [SID:1234512015]).

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"We are gratified by the positive feedback that we have received from healthcare providers, patients and caregivers regarding VARUBI and, pending FDA approval, we look forward to expanding this product franchise in 2017 with the launch of an intravenous formulation," said Lonnie Moulder, CEO of TESARO. "Our pipeline of product candidates continues to advance and expand, with the recent initiations of our Phase 1 trial of TSR-042 and our Phase 1/2 trial of niraparib plus KEYTRUDA, the submission of the IND for TSR-022, and the start of our immuno-oncology drug discovery collaboration with MD Anderson. We look forward to the availability of data from our NOVA registration trial of niraparib during this quarter. Our NOVA study results will be the first data from a prospectively designed, randomized Phase 3 trial for a PARP inhibitor, and the full data from this global trial are intended to support regulatory applications for the U.S. and Europe during the second half of this year."

Recent Business Highlights

The U.S. launch of VARUBI (oral rolapitant) is underway, and an estimated 150 million people, or 80% of potential commercial lives, now have access to and coverage for VARUBI under their insurance plan.
The New Drug Application (NDA) for intravenous (IV) rolapitant was submitted to the U.S. Food and Drug Administration (FDA) and we continue to anticipate a 12 month review timeline.
The Marketing Authorisation Application (MAA) for oral rolapitant is under review by the European Medicines Agency (EMA).
Patient treatment continues in the Phase 3 NOVA trial of niraparib in patients with ovarian cancer, and data are anticipated to become available in the second quarter of 2016.
Enrollment continues in the QUADRA trial of niraparib for the treatment of patients with ovarian cancer who have received three or more prior lines of chemotherapy.
In April, TESARO and Janssen Biotech Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced a global collaboration and license agreement focused on the development and commercialization of niraparib specifically for the treatment of prostate cancer. Separately, Johnson & Johnson Innovation — JJDC made an equity investment in TESARO that was received during the second quarter.
The Phase 1/2 combination trial of niraparib/KEYTRUDA (pembrolizumab) is now enrolling patients.
The Phase 1 dose escalation study of TSR-042, our anti-PD-1 antibody candidate, is now enrolling patients.
The Investigational New Drug (IND) application for TSR-022, our anti-TIM-3 antibody candidate, has been submitted to the FDA.
A clinical antibody candidate targeting LAG-3, TSR-033, has been selected.
TESARO and the Institute for Applied Cancer Science at The University of Texas MD Anderson Cancer Center announced an exclusive collaboration to discover and develop small molecule product candidates against undisclosed immuno-oncology targets, with a goal of identifying the first clinical candidate in early 2017.
TESARO closed a private placement financing in March 2016, resulting in $155 million in proceeds.
TESARO announced the appointment of Dr. Kavita Patel to its Board of Directors.
First Quarter 2016 Financial Results

TESARO reported a net loss of $90.8 million, or ($2.22) per share, for the first quarter of 2016, compared to a net loss of $48.5 million, or ($1.30) per share, for the first quarter of 2015.
Product revenue for the first quarter of 2016 totaled $0.2 million and included sales of VARUBI to specialty pharmacy customers. These sales represent a small portion of total product shipments and the only shipments for which GAAP revenue recognition criteria were met. The majority of VARUBI shipments to date have been to specialty distributors, and these sales have been deferred or cannot yet be recognized.
Research and development expenses increased to $52.6 million for the first quarter of 2016, compared to $33.5 million for the first quarter of 2015, driven primarily by higher costs related to the ongoing registration trials of niraparib, the advancement of our immuno-oncology portfolio, and activities related to rolapitant IV, in addition to increased headcount.
Selling, general and administrative expenses increased to $30.0 million for the first quarter of 2016, compared to $11.2 million for the first quarter of 2015, primarily due to commercial activities in support of the launch of VARUBI, increased commercial headcount, including the establishment of a field sales organization, and higher professional service fees.
Acquired in-process research and development expenses totaled $4.0 million for the first quarter of 2016 and included a milestone payment related to our immuno-oncology portfolio.
Operating expenses, as described above, include total non-cash, stock-based compensation expense of $9.3 million for the first quarter of 2016, compared to $3.9 million for the first quarter of 2015.
As of March 31, 2016, TESARO had approximately $314 million in cash and cash equivalents, which includes proceeds of $155 million resulting from the March private placement. This cash and cash equivalents total excludes the $85 million in up-front payment and equity investment from the Janssen prostate collaboration, which were received in the second quarter.
For the quarter ended March 31, 2016, TESARO had approximately 41.0 million shares outstanding on a weighted average basis. Following completion of the March private placement financing, TESARO had approximately 44.7 million outstanding shares of common stock as of March 31, 2016.
TESARO expects its cash utilization to be approximately $70 million during the second quarter of 2016.
Corporate Objectives

TESARO anticipates achieving the following key objectives:

VARUBI:

Continue to execute on the VARUBI commercial launch in the United States; and
Launch IV rolapitant into the U.S. market in 2017, pending FDA approval.
Niraparib:

Report data from the Phase 3 NOVA trial of niraparib in Q2 2016;
Continue to enroll the Phase 2 QUADRA trial of niraparib;
Submit the niraparib NDA and MAA in 2H 2016;
Continue to enroll patients in the Phase 1/2 combination trial of niraparib/KEYTRUDA (pembrolizumab) through 2016; and
Continue to enroll the Phase 3 BRAVO trial of niraparib in breast cancer patients with germline BRCA mutations and the Phase 3 PRIMA trial in first-line ovarian cancer patients through 2016.
Immuno-Oncology Portfolio:

Initiate the Phase 1 clinical trial for TSR-022 in mid-2016;
Identify a dose and schedule for TSR-042 by the end of 2016;
Select at least one bispecific antibody clinical candidate in 2016; and
Identify the first clinical candidate within the MD Anderson collaboration in early 2017.