On May 5, 2016 Aviragen Therapeutics, Inc. (NASDAQ:AVIR) (formerly Biota Pharmaceuticals, Inc.) reported its financial results for the three month period ended March 31, 2016, which is the third quarter of the Company’s 2016 fiscal year, and also provided an update on recent corporate and clinical developments (Press release, Nabi Biopharmaceuticals, MAY 5, 2016, View Source [SID:1234512028]).

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"This quarter has been very rewarding and highlights significant efforts by the entire team to position the Company for success. We officially changed the name of the Company from Biota to Aviragen to reflect our shift from a drug discovery and early-stage licensing company to one focused on developing next generation antiviral therapies. On the clinical front, we were encouraged by the emerging profile of our RSV fusion inhibitor, BTA585, that successfully completed single and multiple dose Phase 1 trials. Further validating the potential of BTA585 to address significant unmet clinical needs in children and adults infected with RSV was the FDA’s Fast Track designation. The Phase 2a RSV challenge study of BTA585 and Phase 2b HRV SPIRITUS trial of vapendavir are progressing and we look forward to reporting top-line data from both trials in the second half of this year," remarked Joseph M. Patti, PhD, President and Chief Executive Officer of Aviragen Therapeutics.

"We were also successful this quarter in significantly strengthening our balance sheet by divesting our non-core antibiotic intellectual property portfolio and, shortly after the end of the quarter, by adding $20 million of non-dilutive funds from the monetization of a portion of our Inavir royalty. Our enhanced financial position supports our continued investment in advancing our key late-stage product candidates and anti-viral pipeline."

Recent Corporate Highlights

Completed Royalty Deal with Healthcare Royalty Partners for Proceeds of $20 Million.
In April 2016, received gross proceeds of $20 million from HealthCare Royalty Partners from the sale of an undisclosed portion of the Company’s royalty rights related to Inavir, an inhaled neuraminidase inhibitor that is approved in Japan for the treatment and prevention of influenza.

Transitioned Company Name to Aviragen Therapeutics, Inc. (NASDAQ:AVIR) from Biota Pharmaceuticals, Inc. The name change reflects the strategic shift in the organization’s prior focus on drug discovery and early-stage licensing to clinical development of next generation direct-acting antivirals to treat infections that have limited therapeutic options.

Announced Sale of Antibiotic Assets to Spero Therapeutics. Completed the sale of assets related to the Company’s broad spectrum antibiotic program to a newly formed subsidiary of Spero Therapeutics, LLC, a Cambridge-based biopharmaceutical company founded to develop novel therapies for the treatment of bacterial infections.

Recent Clinical Highlights

Initiated Phase 2a Efficacy Study of BTA585 for the Treatment of Respiratory Syncytial Virus (RSV) Infections. Reported the initiation of a double-blind, placebo-controlled, Phase 2a trial that is designed to evaluate the safety, pharmacokinetics, and antiviral activity of orally-dosed BTA585 in healthy volunteers challenged intranasally with RSV. The primary endpoint of the study is reduction in viral load among subjects who test positive for RSV prior to dosing.

Reported Positive Results from Phase 1 Trial for RSV Antiviral BTA585. Reported top-line safety and pharmacokinetic data from a Phase 1 multiple ascending dose (MAD) trial of BTA585. Results from the MAD trial indicated BTA585 was generally well tolerated at all dose levels; there were no serious adverse events, and no drug-related clinically-significant adverse changes were observed in either ECGs or clinical laboratory values.

Received Fast Track Designation for RSV Antiviral BTA585. Granted Fast Track designation by the FDA for BTA585, an oral fusion inhibitor, for the treatment of RSV infections in infants, young children and adults. The FDA Fast Track process is designed to expedite the development and review of drugs for the treatment of serious or life-threatening conditions and which demonstrate potential to address unmet medical needs.

Commenced Dosing in Phase 2 Trial of BTA074 for Topical Treatment of Condyloma. Dosed first subject in a Phase 2 double-blind, randomized, placebo-controlled trial to evaluate the safety, tolerability and efficacy of BTA074 5% gel in male and female patients with condyloma, or anogenital warts, caused by human papillomavirus (HPV) types 6 & 11.

Financial Results for the Three Month Period Ended March 31, 2016

The Company reported a net loss of $5.2 million for the three month period ended March 31, 2016, as compared to net income of $1.2 million in the same quarter of the prior fiscal year. Basic and diluted net loss per share was $0.14 for the three month period ended March 31, 2016, as compared to a basic and diluted net income per share of $0.03 in the same period of 2015.

Revenue decreased to $5.3 million for the three month period ended March 31, 2016 from $5.9 million in the same period in 2015 due to a $0.2 million decrease in royalty revenues from sales of the flu products Relenza and Inavir. The lower royalties were a result of reduced Relenza government stockpiling orders, which were largely offset by higher royalties from Inavir sales in Japan. Also contributing to the lower revenues was a $0.4 million decrease in revenue from services, as a result of the termination of the Company’s contract with BARDA in 2014.

Cost of revenue decreased to zero for the three month period ended March 31, 2016 from $0.3 million in the same period last year due to the termination of the Company’s contract with BARDA in 2014.

Research and development expense increased to $8.5 million for the three month period ended March 31, 2016 from $4.8 million in the same period in 2015. The increase was the result of $4.4 million in higher clinical costs related to: the ongoing Phase 2b SPIRITUS trial for vapendavir; the introduction of BTA585 into clinical trials this year, including a Phase 1 SAD/MAD trial and startup costs for a Phase 2a challenge trial; and expenses for the initiation of a Phase 2 trial for BTA074. These costs were offset in part by a decrease of $0.7 million in depreciation and facility related expenses associated with the closure of the Company’s early-stage research facility in March 2015.

General and administrative expense decreased to $2.3 million for the three month period ended March 31, 2016 from $3.2 million in the same period in 2015, due largely to lower staff-related expenses and the absence this year of professional fees incurred during the acquisition of BTA074 in 2015.

The Company held $50.0 million in cash, cash equivalents, and short and long-term investments as of March 31, 2016. Additionally, in April, the Company received gross proceeds of $20 million from the sale of a portion of the royalties it receives from the flu medication, Inavir, increasing the Company’s available cash to approximately $70 million.

On May 5, 2016 DURECT Corporation (Nasdaq: DRRX) reported financial results for the first quarter of 2016 (Filing, Q1, DURECT, 2016, MAY 5, 2016, View Source [SID:1234512022]). Total revenues were $3.6 million and net loss was $7.9 million for the three months ended March 31, 2016 as compared to total revenues of $4.8 million and net loss of $4.9 million for the three months ended March 31, 2015.

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At March 31, 2016, we had cash and investments of $24.3 million, compared to cash and investments of $29.3 million at December 31, 2015. Subsequent to the end of the first quarter, we raised net proceeds of approximately $17.0 million from the sale of additional shares of common stock. Including these proceeds, our pro forma cash and investments at March 31, 2016 would have been approximately $41.3 million. At March 31, 2016, we had $19.7 million in short and long term debt.
"The highlight of the quarter was undoubtedly the resubmission of the REMOXY NDA, followed by its acceptance for review by the FDA and the establishment of a September 25, 2016 PDUFA date," stated James E. Brown, D.V.M., President and CEO of DURECT. "With respect to DUR-928, we have progressed into our first two patient studies with results anticipated during the course of this year. For POSIMIR, we continued the PERSIST Phase 3 trial which we are in the process of amending in response to an FDA recommendation."
Update of Selected Programs:

• Epigenomic Regulator Program. DUR-928, our Epigenomic Regulator Program’s lead product candidate, is an endogenous, small molecule, new chemical entity (NCE), which may have broad applicability in several metabolic diseases such as nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH), and in acute organ injuries such as acute kidney injury.
During the first quarter, we began our first patient trial utilizing DUR-928. This study is an open-label single-ascending-dose safety and pharmacokinetic Phase 1b trial of DUR-928 in NASH patients and matched control subjects. This study will be conducted in successive cohorts evaluating single-dose levels of oral DUR-928. After a PK/safety review at each dose, the study can proceed to the next higher dose. The study is being conducted in Australia, and we anticipate that we will start obtaining results from this trial in the second quarter of 2016. This study is designed to enable and inform a subsequent multi-dose study in NASH or other patients with other liver function impairment.
In addition, our protocol has been approved by the institutional review board for a second study in patients with DUR-928, also being conducted in Australia. This Phase 1b trial of DUR-928 is an open-label single-ascending-dose safety and pharmacokinetic study in patients with impaired kidney function and matched control subjects. This study will be

1
conducted in successive cohorts evaluating single-dose levels of DUR-928 administered by injection. After a PK/safety review at each dose, the study can proceed to the next higher dose. We anticipate that this study will be completed in 2016, and that this study will enable and inform subsequent trials for patients with either acute kidney injury or other kidney function impairment.

• REMOXY (oxycodone) Extended-Release Capsules CII. Based on our ORADUR technology, REMOXY is a unique long-acting formulation of oxycodone designed to discourage common methods of tampering associated with opioid misuse and abuse. Pain Therapeutics (our licensee) resubmitted the NDA on schedule in March 2016. In April 2016, Pain Therapeutics announced that the FDA had determined that the NDA was sufficiently complete to permit a substantive review and that September 25, 2016 is the target action date under the Prescription Drug User Fee Act (PDUFA). The extended release oxycodone market is greater than $2 billion in the U.S. alone, and we are eligible for a potential royalty on REMOXY between 6.0% to 11.5% of net sales depending on sales volumes.

• POSIMIR (SABER-Bupivacaine) Post-Operative Pain Relief Depot. In November 2015, we began enrolling patients for PERSIST, a new POSIMIR Phase 3 clinical trial, consisting of patients undergoing laparoscopic cholecystectomy (gallbladder removal) surgery. In a previous clinical trial of 50 patients undergoing laparoscopic cholecystectomy, POSIMIR was compared with the active control bupivacaine hydrochloride, against which POSIMIR demonstrated in a post hoc analysis an approximately 25% reduction in pain intensity on movement for the first 3 days after surgery (p=0.024), using the same statistical methodology specified for the current trial. We began recruiting patients for this trial with an intent to compare POSIMIR to placebo. Based on recommendations from the FDA received subsequent to the start of the trial, in April 2016 we decided to amend the PERSIST trial including by incorporating standard bupivacaine HCl as an active control. This change will add to the time and cost to complete the PERSIST trial, but we believe that a positive outcome from this trial design would result in a stronger NDA filing and potentially commercial advantages. This clinical trial is designed to generate data necessary to support an NDA resubmission.
POSIMIR is our investigational post-operative pain relief depot that utilizes our patented SABER technology and is intended to deliver bupivacaine to provide 3 days of pain relief after surgery. We are in discussions with potential partners regarding licensing development and commercialization rights to POSIMIR, for which we hold worldwide rights. We are also continuing to evaluate the requirements for commercializing POSIMIR on our own in the U.S., in the event that we determine that to be the preferred route of commercialization.

• Relday (Risperidone Program). Relday is a proprietary, long-acting, once-monthly subcutaneous injectable formulation of risperidone for the treatment of schizophrenia. In September 2015, Zogenix (our licensee) announced that they had completed a multi-dose Phase 1b trial with results consistent with the profile of risperidone and a previous Phase 1 single-dose clinical trial. Zogenix has stated that it is seeking a development and commercialization partner for Relday and that Relday is well-positioned to begin a Phase 3 program once a partner is secured.

•
ORADUR-ADHD Program. In 2013, we selected a formulation for the lead program in our ORADUR-ADHD (Attention Deficit Hyperactivity Disorder) program, ORADUR-Methylphenidate. This formulation was chosen based on its potential for rapid onset of
action, long duration with once-a-day dosing and target pharmacokinetic profile as demonstrated in a Phase 1 trial. In addition, this product candidate utilizes a small capsule size relative to the leading existing long acting products on the market and incorporates our ORADUR anti-tampering technology. Orient Pharma, our licensee in defined Asian and South Pacific countries, has initiated a Phase 3 study in Taiwan and anticipates completing it in 2016. We retain rights to all other markets in the world, notably including the U.S., Europe and Japan, and are engaged in licensing discussions with other companies.

• Business Development Activities. We have multiple programs that may potentially be licensed over the next 12-18 months. These include POSIMIR, DUR-928, ORADUR-ADHD (territories outside certain Asian and South Pacific markets), as well as various other programs which we have not described publicly in detail.
Earnings Conference Call
A live audio webcast of a conference call to discuss first quarter 2016 results will be broadcast live over the internet at 4:30 p.m. Eastern Time on May 5 and is available by accessing DURECT’s homepage at www.durect.com and clicking "Investor Relations." If you are unable to participate during the live webcast, the call will be archived on DURECT’s website under Audio Archive in the "Investor Relations" section.

On May 05, 2016 Conatus Pharmaceuticals Inc. (Nasdaq:CNAT), a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, reported financial results for the first quarter ended March 31, 2016, and provided updates on its development programs (Filing, Q1, Conatus Pharmaceuticals, 2016, MAY 5, 2016, View Source [SID:1234512021]). After the market close yesterday, the company announced top-line results from the second stage of its Phase 2 Liver Cirrhosis trial. A conference call and webcast are scheduled for 8:00 a.m. ET today, as detailed below, to discuss both the trial results and financial results.

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Financial Results
The net loss was $7.3 million for the first quarter of 2016 compared with $6.0 million for the first quarter of 2015.

Research and development expenses increased to $4.7 million for the first quarter of 2016 from $3.9 million for the first quarter of 2015, primarily due to higher external clinical trial and manufacturing costs. General and administrative expenses increased to $2.6 million for the first quarter of 2016 from $2.1 million for the first quarter of 2015, primarily due to higher legal, consulting and accounting fees.

Cash, cash equivalents and marketable securities were $32.6 million at March 31, 2016, compared with $36.5 million at December 31, 2015. The company believes current financial resources are sufficient to maintain operations and ongoing clinical development activities for at least the next 12 months.

Program Updates
Conatus is developing emricasan, a first-in-class, orally active pan-caspase inhibitor, for the treatment of patients with chronic liver disease. To date in 2016, the company announced:

in January, positive top-line results from the three-month, double-blind, placebo-controlled first stage of the company’s Phase 2 Liver Cirrhosis clinical trial, evaluating potential improvements in Model for End-stage Liver Disease (MELD) score and Child-Pugh-Turcotte status in patients with liver cirrhosis and baseline MELD scores of 11 to 18, and in May, positive top-line results from the three-month, open-label second stage of the Liver Cirrhosis clinical trial;

in January, the initiation of active recruitment in its double-blind, placebo-controlled Phase 2b ENCORE-NF (EmricasaN, a Caspase inhibitOR, for Evaluation in patients with nonalcoholic steatohepatitis (NASH), and confirmed resultant Fibrosis) clinical trial;

in February, U.S. Food and Drug Administration (FDA) Fast Track designation for the development of emricasan in patients with liver cirrhosis caused by NASH;

an oral late-breaker presentation (#LBO5) entitled, "Emricasan (IDN-6556) orally for three months in patients with cirrhosis and MELD scores 11-18 improves clinical parameters of cirrhosis in patients with baseline MELD score ≥15," delivered at The International Liver Congress 2016, the Annual Meeting of the European Association for the Study of the Liver (EASL) in Barcelona, Spain, by Catherine Frenette, M.D., Medical Director of Liver Transplantation at Scripps Clinic, La Jolla, CA, and a principal investigator in the company’s multicenter Phase 2 Liver Cirrhosis clinical trial of emricasan; and

a poster (#FRI-078) entitled, "The potent pan-caspase inhibitor IDN-7314 does not affect tumor growth rate nor does it antagonize the efficacy of sorafenib in models of hepatocellular carcinoma," presented at The International Liver Congress 2016, the Annual Meeting of the European Association for the Study of the Liver (EASL) in Barcelona, Spain, by Patricia C. Contreras, Ph.D., Vice President, Preclinical Development at Conatus and lead author on the poster.
Conatus has two ongoing emricasan Phase 2 clinical trials:

POLT-HCV-SVR: A randomized, double blind, placebo-controlled Phase 2b clinical trial initiated in May 2014 evaluating potential improvements in Ishak Fibrosis Score in post-orthotopic liver transplant (POLT) recipients with liver fibrosis or cirrhosis post-transplant as a result of recurrent HCV infection who have successfully achieved a sustained viral response (SVR) following HCV antiviral therapy. Results after two years of twice-daily treatment or placebo are expected in the first half of 2018.

ENCORE-NF: A randomized, double blind, placebo-controlled Phase 2b clinical trial initiated in January 2016 evaluating potential improvements in fibrosis and steatohepatitis in patients with NASH fibrosis. Results after 18 months of twice-daily treatment or placebo are expected in 2018.
The company plans to initiate the following additional emricasan clinical trials on a staggered basis through early 2017 as resources permit and expects top-line results to be available periodically beginning in 2018, which the company believes could position it to advance directly to filing for accelerated approval in NASH cirrhosis:

ENCORE-PH: A planned randomized, double-blind, placebo-controlled clinical trial to evaluate the effect of emricasan in reducing hepatic venous pressure gradient (HVPG) in patients with clinically significant Portal Hypertension and impaired hepatic function in patients with NASH cirrhosis.

ENCORE-LF: A planned randomized, double-blind, placebo-controlled clinical trial to assess long-term Liver Function endpoints of MELD score and Child-Pugh-Turcotte status, related serum biomarkers and laboratory parameters associated with liver function, and will collect chronic administration safety information in patients with NASH cirrhosis. With the continued engagement of the regulatory authorities, the six-month data from the Liver Cirrhosis trial may allow redesign of the ENCORE-LF clinical trial, originally planned as a Phase 2 trial, to qualify as a Phase 3 clinical trial.

ENCORE-XT: A planned eXTension clinical trial to continue treatment for at least an additional 18 months, for a total of at least two years, in patients who complete the ENCORE-PH or ENCORE-LF trials, with continued monitoring for efficacy, safety, clinical outcomes and health-related quality of life.

On May 5, 2016 Sarepta Therapeutics, Inc.(NASDAQ:SRPT), a developer of innovative RNA-targeted therapeutics, reported financial results for the three months ended March 31, 2016, and provided an update of recent corporate developments (Press release, Sarepta Therapeutics, MAY 5, 2016, View Source;p=RssLanding&cat=news&id=2165380 [SID:1234512019]).
"The Peripheral and Central Nervous System Advisory Committee met last week to review eteplirsen for the treatment of Duchenne muscular dystrophy amenable to exon 51 skipping, and we await our May 26 PDUFA date," said Edward Kaye, M.D., Sarepta’s interim chief executive officer and chief medical officer. "Following the FDA’s decision, we plan to provide a clinical and corporate update."

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Financial Results
For the first quarter of 2016, Sarepta reported a non-GAAP net loss of $52.5 million, or $1.15 per share, compared to a non-GAAP net loss of $47.4 million for the first quarter of 2015, or $1.15 per share. The incremental loss of $5.1 million was primarily the result of increased operating expenses.

On a GAAP basis, the net loss for the first quarter of 2016 was $59.8 million, or $1.31 per share (including $7.2 million of stock-based compensation and restructuring expenses), compared to a net loss of $61.6 million, or $1.49 per share (including $14.2 million of stock-based compensation) for the first quarter of 2015.

No revenue was recognized for the three months ended in both March 31, 2016 and 2015.
Non-GAAP research and development expenses were $35.9 million for the first quarter of 2016, compared to $36.7 million for the first quarter of 2015, a decrease of $0.8 million. GAAP research and development expenses were $38.8 million for the first quarter of 2016 (including $3.0 million of stock-based compensation and restructuring expenses), compared to $39.2 million for the first quarter of 2015 (including $2.4 million of stock-based compensation), a decrease of $0.3 million.

Non-GAAP general and administrative expenses were $16.6 million for the first quarter of 2016, compared to $11.0 million for the first quarter of 2015, an increase of $5.6 million. GAAP general and administrative expenses were $20.9 million for the first quarter of 2016 (including $4.3 million of stock-based compensation and restructuring expenses), compared to $22.7 million for the first quarter of 2015 (including $11.7 million of stock-based compensation), a decrease of $1.8 million.

The Company had $140.6 million in cash, cash equivalents, short-term investments and restricted cash as of March 31, 2016 compared to $204.0 million as of December 31, 2015, a decrease of $63.4 million. The decrease was due to the use of cash to fund the Company’s ongoing operations, commercial launch activities and related inventory build.

In addition to the GAAP financial measures set forth in this press release, the Company has included certain non-GAAP measurements: non-GAAP research and development expenses, non-GAAP general and administrative expenses, non-GAAP operating expense adjustments, non-GAAP net loss, and non-GAAP basic and diluted net loss per share, which present operating results on a basis adjusted for certain items. The Company uses these non-GAAP measures as key performance measures for the purpose of evaluating performance internally. The Company also believes these non-GAAP measures provide the Company’s investors with useful information regarding the Company’s historical operating results. These non-GAAP measures are not intended to replace the presentation of the Company’s financial results in accordance with GAAP. Use of the terms non-GAAP research and development expenses, non-GAAP general and administrative expenses, non-GAAP operating expense adjustments, non-GAAP net loss, and non-GAAP basic and diluted net loss per share may differ from similar measures reported by other companies. All relevant non-GAAP measures are reconciled from their respective GAAP measures in the attached table "Reconciliation of GAAP to Non-GAAP Net Loss."

Recent Corporate Developments
Duchenne Muscular Dystrophy Program
–Sarepta Issues Statement on Advisory Committee Meeting Outcome for Use of Eteplirsen in the Treatment for Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping
–Sarepta Therapeutics Announces FDA Advisory Committee Meeting to Review Eteplirsen as a Treatment for Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping
Corporate Updates
–Sarepta Therapeutics Announces Long Term Plan to Consolidate Facilities within Massachusetts

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.