On May 05, 2016 (GLOBE NEWSWIRE) — Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported financial results for the first quarter ended March 31, 2016 (Press release, Sunesis, MAY 5, 2016, View Source;p=RssLanding&cat=news&id=2165397 [SID:1234512014]). Loss from operations for the three months ended March 31, 2016 was $10.1 million. As of March 31, 2016, cash, cash equivalents and marketable securities totaled $40.0 million.

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"The first quarter of 2016 saw several important milestones, including, notably, the advancement of our unique BTK-inhibitor SNS-062 into the clinic in a Phase 1A study," said Daniel Swisher, Chief Executive Officer of Sunesis. "Resistance to available BTK-inhibitors is a growing concern, and SNS-062’s characteristics as a non-covalently binding inhibitor position it to address this emerging unmet need. Ongoing dose escalation in our Healthy Volunteer Study is proceeding well. We are actively planning for our Phase 1B/2 study in patients with B-cell malignancies to start later this year."

Mr. Swisher added: "We also continue to progress our efforts to bring vosaroxin to market in Europe as an important new treatment option for patients with relapsed/refractory AML. Our Marketing Authorization Application has now reached the 120-day comment and question time point. With continued regulatory advancement and strong outreach efforts underway, we aim to enter into a European collaboration later this year to support a market launch in 2017."

First Quarter 2016 and Recent Highlights

First Subject Dosed in Phase 1A Healthy Volunteer Study Evaluating Oral Non-Covalent BTK-inhibitor SNS-062. In March 2016, the first patient was dosed in a Phase 1A, randomized, double-blind, placebo-controlled dose-ranging study to investigate the safety, pharmacokinetics and pharmacodynamics of its oral, next-generation, non-covalently binding BTK-inhibitor, SNS-062, in healthy subjects. If a successful outcome is achieved in Phase 1A SNS-062 is expected to proceed to a Phase 1B/2 study in patients with B-cell malignancies later this year.

Secured $15 Million Venture Loan. In March 2016, Sunesis entered into a $15 million loan agreement with Bridge Bank, a division of Western Alliance Bank, and Solar Capital Ltd. The loan was used for the repayment of existing indebtedness and will be used for general corporate purposes.

First Patient Treated in Vanderbilt University-Sponsored Phase 2 VITAL Study of Vosaroxin in Combination with Infusional Cytarabine in Patients with Previously Untreated AML. In March 2016, the first patient was treated in an investigator-sponsored study of vosaroxin and cytarabine in adult patients with previously untreated acute myeloid leukemia (AML). The trial is being conducted at the Vanderbilt-Ingram Cancer Center at Vanderbilt University under the direction of Michael R. Savona, M.D., FACP, Associate Professor of Medicine and Director of Hematology Early Therapeutics Program, and Stephen A. Strickland, M.D., MSCI, Assistant Professor of Medicine.

Strengthened Executive Management Team and Board of Directors. In March 2016, Sunesis announced the appointment of Geoffrey Parker to the Sunesis Board of Directors. In February 2016, Sunesis announced the promotion of Deborah A. Thomas, Ph.D., to the role of Senior Vice President, Regulatory Affairs, Quality Assurance, and Non-Clinical Development.

Validation of Marketing Authorization Application by the European Medicines Agency for Vosaroxin in AML. At year-end 2015, the European Medicines Agency (EMA) validated the Marketing Authorization Application (MAA) for vosaroxin as a treatment for relapsed refractory acute myeloid leukemia (AML) in patients aged 60 years and older. Validation confirms that the submission is complete and initiates the Centralized Review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP). The MAA, if authorized, provides a marketing license valid in all 28 EU member states.

Financial Highlights

Cash, cash equivalents and marketable securities totaled $40.0 million as of March 31, 2016, as compared to $46.4 million as of December 31, 2015. The decrease of $6.4 million was primarily due to $10.7 million of net cash used in operating activities and $8.0 million of principal and final payments against notes payable, partially offset by $12.3 million raised from debt financing. An additional $2.5 million in net loan proceeds was received on April 1, 2016. This capital is expected to be sufficient to fund operations through the second quarter of 2017.

Revenue for the three months ended March 31, 2016 was $0.6 million, as compared to $0.9 million for the same period in 2015. The decrease between the periods was primarily due to the increase in estimated performance period through which the remaining balance of deferred revenue will be amortized.

Research and development expense was $6.2 million for the three months ended March 31, 2016 as compared to $4.5 million for the same period in 2015. The increase between the periods was primarily due to the increase of $1.3 million in consulting and other outside services costs and $0.4 million in clinical trials and medical affairs expenses.

General and administrative expense was $4.3 million for the three months ended March 31, 2016 as compared to $5.1 million for the same period in 2015. The decrease between the periods was primarily due to a $0.8 million decrease in personnel costs and professional services and commercial costs.

Interest expense was $0.3 million for the three months ended March 31, 2016, compared to $0.2 million for the same period in 2015.

Net other income was nil for the three months ended March 31, 2016 as compared to net other expense of $0.1 million for the same period in 2015. The amount for the period in 2015 was primarily comprised of non-cash credits or charges for the revaluation of warrants issued in the October 2010 underwritten offering.

Cash used in operating activities was $10.7 million for the three months ended March 31, 2016, including a $0.5 million milestone payment relating to the MAA filing, as compared to $11.6 million for the same period in 2015.

Sunesis reported loss from operations of $9.9 million for the three months ended March 31, 2016 as compared to $8.8 million for the same period in 2015. Net loss was $10.1 million for the three months ended March 31, 2016, as compared to $9.1 million for the same period in 2015.

Conference Call Information

Sunesis will host an update conference call today, May 5th at 11:00 a.m. Eastern Time. The call can be accessed by dialing (877) 771-6242 (U.S. and Canada) or (440) 996-5676 (international) and entering passcode 96476414. To access the live audio webcast, or the subsequent archived recording, visit the "Investors and Media – Calendar of Events" section of the Sunesis website at www.sunesis.com. The webcast will be recorded and available for replay on the company’s website for two weeks.

About QINPREZO (vosaroxin)

QINPREZO (vosaroxin) is an anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Preclinical data demonstrate that vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the U.S. Food and Drug Administration (FDA) and European Commission have granted orphan drug designation to vosaroxin for the treatment of AML. Additionally, vosaroxin has been granted fast track designation by the FDA for the potential treatment of relapsed or refractory AML in combination with cytarabine. Vosaroxin is an investigational drug that has not been approved for use in any jurisdiction.

The trademark name QINPREZO is conditionally accepted by the FDA and the EMA as the proprietary name for the vosaroxin drug product candidate.

On May 4, 2016 Novavax, Inc., (Nasdaq:NVAX) a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, reported its financial results for the first quarter ended March 31, 2016 (Filing, Q1, Novavax, 2016, MAY 5, 2016, View Source [SID:1234512052]).

Novavax First Quarter Achievements:

· Continued execution of Resolve, a pivotal Phase 3 trial of our RSV F Vaccine in older adults (60 years of age and older). Resolve is a randomized, observer-blinded, placebo-controlled trial in 11,850 older adults at 60 sites in the United States. The primary efficacy objective is the prevention of moderate-severe RSV-associated lower respiratory tract disease, as defined by the presence of multiple lower respiratory tract symptoms. Enrollment was completed in the fourth quarter of 2015.

· Ongoing execution of a Phase 2 rollover clinical trial of our RSV F Vaccine in 1,330 older adults. The trial is a randomized, observer-blinded, placebo-controlled rollover trial designed to enroll from the population of older adults who participated in the prior Phase 2 trial. The primary endpoints of the trial will evaluate safety and serum anti-F IgG antibody concentrations in response to immunization with our RSV F Vaccine. Enrollment was completed in the fourth quarter of 2015.

· Expanded enrollment of Prepare, a pivotal Phase 3 trial of our RSV F Vaccine in healthy pregnant women, to multiple international sites to take advantage of the RSV season in the southern hemisphere. Prepare is a randomized, observer-blinded, placebo-controlled trial. The primary objective is to determine the efficacy of maternal immunization with our RSV F Vaccine against symptomatic RSV lower respiratory tract infection with hypoxemia in infants through the first 90 days of life. Prepare is supported by a grant of up to $89 million from the Bill & Melinda Gates Foundation (BMGF).

· Issued a total of $325 million Convertible Senior Notes, resulting in net proceeds of $276.5 million. The Notes’ initial conversion price of approximately $6.81 per common share represents a 22.5% premium to Novavax’ common stock on January 25, 2016, the day the Notes were issued. In conjunction with the issuance of the Notes, the Company entered into capped call transactions with an initial cap price of $9.73 per share. The capped call will serve to reduce dilution from issuance of shares upon conversion at prices greater than the Notes’ conversion price of $6.81.

· Appointed Bob Darius to Senior Vice President, Quality Operations and promoted Gregory M. Glenn, M.D., to President, Research & Development, Amy B. Fix to Senior Vice President, Regulatory Affairs, Louis F. Fries III, M.D., to Senior Vice President and Chief Medical Officer, and Iksung Cho to Vice President, Biostatistics.

2016 Anticipated Events:

· Announce top-line data from Resolve, the Phase 3 pivotal RSV F Vaccine trial in older adults in the third quarter of 2016; and

·
Announce top-line data from the Phase 2 RSV F Vaccine rollover trial in older adults in the second half of 2016.

Summary

"During the first quarter, we continued to successfully execute on our two ongoing pivotal Phase 3 trials of our RSV F Vaccine. We also raised $325 million in a successful Convertible Senior Notes offering, which strengthens Novavax’ balance sheet ahead of data from the pivotal Phase 3 Resolve clinical trial," said Stanley C. Erck, President and CEO. "We are pleased to see significant interest from a number of multinational, world-class vaccine companies seeking potential partnership and commercialization rights to our RSV F Vaccine franchise outside of North America. We remain well positioned to announce value creating data from the Resolve trial and the Phase 2 rollover trial in older adults in 2016."

Financial Results for the Three Months Ended March 31, 2016

Novavax reported a net loss of $77.3 million, or $0.29 per share, for the first quarter of 2016, compared to a net loss of $24.4 million, or $0.10 per share, for the first quarter of 2015.

Novavax revenue in the first quarter of 2016 decreased 57% to $4.2 million, compared to $9.9 million for the same period in 2015. Lower revenue under the HHS BARDA contract of $7.3 million is the primary driver of this decrease. The lower HHS BARDA revenue is the result of a lower level of activity in the three months ended March 31, 2016, as compared to the same period in 2015, along with a one-time revenue recognition of $3.1 million in the first quarter of 2015. This decrease in HHS BARDA revenue was partially offset by $1.6 million in revenue recorded under the BMGF grant relating to our ongoing Prepare clinical trial.

Research and development expenses increased 143% to $69.0 million in the first quarter of 2016, compared to $28.3 million for the same period in 2015. The increase in research and development expenses was primarily due to increased costs associated with the clinical trials and development activities of our RSV F Vaccine and higher employee-related costs, including non-cash stock-based compensation.

General and administrative expenses increased 80% to $10.5 million in the first quarter of 2016, compared to $5.8 million for the same period in 2015. The increase was primarily due to higher employee-related costs, including non-cash stock-based compensation expense, and professional fees for pre-commercialization activities, as compared to the same period in 2015.

Interest income (expense), net for the first quarter of 2016 includes $2.1 million of interest expense relating the Company’s Convertible Senior Notes offering.

As of March 31, 2016, the company had $433.9 million in cash and cash equivalents and marketable securities compared to $230.7 million as of December 31, 2015. Net cash used in operating activities for the first quarter of 2016 was $69.8 million, compared to $30.5 million for same period in 2015. The increase in cash usage was primarily due to increased costs relating to our RSV F Vaccine, higher employee-related costs and timing of vendor payments. As previously mentioned, Novavax completed a $325 million Convertible Senior Notes offering in the first quarter of 2016.

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On May 5, 2016 Medivation, Inc. (NASDAQ:MDVN) reiterating its rejection of Sanofi’s substantially inadequate proposal to acquire the Company for $52.50 per share in cash, following the receipt of a letter from Sanofi (Press release, Medivation, MAY 5, 2016, View Source [SID:1234511986]).

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Medivation notes that Sanofi’s letter simply restates an inadequate proposal that the Medivation Board of Directors has already determined substantially undervalues the Company, its leading oncology franchise, and innovative late-stage pipeline. Medivation’s Board of Directors believes the execution of Medivation’s business plan will deliver value to its stockholders that is far superior to Sanofi’s proposal. Medivation’s Board will continue to act in the best interest of its stockholders.

As previously announced, the Company will host a live teleconference with management to discuss first quarter 2016 results, followed by a presentation to review the Company’s business performance and future prospects today at 4:30 p.m. Eastern Time.

A press release announcing the first quarter 2016 will be released after markets close on May 5, 2016.

Individuals may access the live audio webcast of the two hour live teleconference and presentation materials by visiting: View Source Please connect to the website prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary to listen to the webcast.
Interested parties may also listen to the teleconference:
U.S. Dial-in number: 877-303-2523
International Dial-in number: +1-253-237-1755
Conference ID: 95457891
Evercore and J.P. Morgan are serving as financial advisors to Medivation, and Wachtell, Lipton, Rosen & Katz and Cooley LLP are acting as legal counsel.

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.

On May 5, 2016 Oncolytics Biotech Inc. ("Oncolytics" or the "Company") (TSX: ONC) (OTCQX: ONCYF) (FRA: ONY) reported a poster presentation by researchers, covering preclinical work in squamous cell carcinoma of the head and neck ("SCCHN"), is being made at the 2016 American Society of Gene and Cell Therapy ("ASGCT") annual meeting being held from May 4th to 7th, 2016 in Washington, DC (Filing, 6-K, Oncolytics Biotech, MAY 5, 2016, View Source [SID:1234512053]).

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"Preclinical work continues to play an important role in REOLYSIN’s further development," said Dr. Brad Thompson, President and CEO of Oncolytics. "We are evaluating REOLYSIN in combination with both established and emerging treatment options in a range of indications in order to determine which pairings merit clinical testing."

The abstract/poster is titled "The Potency of a Histone Deacetylase Inhibitor and REOLYSIN in Head and Neck Squamous Cell Carcinoma," and was authored by Old, et al. The authors used the first FDA approved histone deacetylase inhibitor ("HDACi"), vorinostat (suberoylanilide hydroxamic acid) ("SAHA"), in combination with REOLYSIN in vitro and in vivo. They had previously found a synergistic combination of SAHA and REOLYSIN in a nude mouse model. Preclinical models using oncolytics are often conducted in immunocompromised mice, negating the significant impact of the immune system. The data demonstrates that combination of reovirus plus SAHA therapy has significant activity in the treatment of SCCHN, even in an immunocompetent model and that immune system rebound likely plays a significant role in the long-term anti-tumor response.