On June 7, 2016 Oxford University Innovation reported that it will be renamed Oxford University Innovation, in order to enhance the already strong links between Oxford University Innovation and the University1 (Press release, Oxford University Innovation, JUN 7, 2016, View Source [SID1234520264]). This will strengthen awareness of the company and its services within the wider University, and better portray the University’s ownership of the company.

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With a record 16 spinout companies launched and more than 450 academic consultancy contracts signed in the last 12 months, innovation activity in Oxford University is successful, growing, and making a significant contribution to the local economy. Professor Ian Walmsley, Pro-Vice-Chancellor (Research and Innovation) at the University of Oxford, added his voice to the recent Oxfordshire Green Paper2 concerning the future of the region, saying: "We are very pleased that the key regional leaders have joined to frame a vision for the future of Oxfordshire that brings together their aspirations for economic growth with improved quality of life and how innovation can contribute to achieving this vision."

Support for enterprise and innovation is at the heart of the University’s Strategic Plan3. The Oxford University Innovation Working Group4 recognised the vital role of Isis Innovation in technology transfer as a key service to Divisions, and made recommendations to establish still firmer connections. Various practical steps have already been taken to meet this objective, including establishing regular staffing at hotdesks in University departments. The new company name and branding – being introduced later this month – will further reinforce this.

An additional, secondary, consideration was the similarity of the current name to so-called Islamic State, which caused occasional business issues such as emails being blocked. However, the overriding reason for change – clearer definition of the link to the University – was compelling in its own right, and received unanimous support in our consultation process.

Managing Director of Isis Innovation, Linda Naylor, said, "Commercialising University research and expertise is important to enable wider society to benefit from the work of our world-leading academics. By changing our name to Oxford University Innovation the breadth of support from the University for entrepreneurial researchers will be more visible. We will also benefit from the global brand recognition of the University, allowing us to attract more clients and investors for the Intellectual Property-based technologies and for the many services that we provide to increase engagement with researchers. More successful engagements will contribute to greater impact from researchers’ work as well as greater financial returns to the University and individual researchers."

Further new initiatives supporting innovation within the University will be announced over the coming months.

On June 7, 2016 Delcath Systems, Inc. (NASDAQ: DCTH), a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, reported it has entered into a securities purchase agreement with an institutional investor to issue $35.0 million of senior convertible notes (the Notes) and related common stock purchase warrants (Press release, Delcath Systems, JUN 7, 2016, View Source;p=RssLanding&cat=news&id=2175682 [SID:1234513107]). The Notes will be issued at an 8% original issue discount. The aggregate proceeds of $32.2 million will be used to fund the Company’s ongoing operations, commercial activities and clinical development programs, including its global Phase 3 trial with Melphalan/HDS in hepatic dominant ocular melanoma (the FOCUS Trial) and its global Phase 2 program with Melphalan/HDS in hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC).

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Of the $32.2 million in aggregate proceeds, $3 million will be unrestricted and immediately and freely available for use by the Company and its subsidiaries. The remaining $29.2 million will be subject to a cash covenant restricting its use and requiring it to be held in certain control accounts of the Company. Subsequently, $3.0 million of the restricted cash shall become unrestricted cash on the 20th trading day after the later of the stockholder approval of the transaction in accordance with NASDAQ rules, or the six-month anniversary of the closing date (such 20th trading day, the Trigger Date). Thereafter, the remaining $26.2 million of restricted cash will become unrestricted in equal quarterly installments starting the 30th trading day after the Trigger Date, such that the balance will become unrestricted by December 29, 2017, subject to the fulfillment of certain equity conditions.

The Notes will be convertible, at the option of the holder, at 110% of the market price (the Conversion Price) into a fixed number of common shares. The market price will be determined on the closing date and will be based on the Volume Weighted Average Price (VWAP) of the three trading days immediately prior to the closing date. Commencing on the 20th trading day after the six-month anniversary of the closing date, and for each 20th trading day period thereafter, the Notes will amortize in equal installments payable in common stock (at the installment conversion price with pre-delivery and a $0.05 floor), subject to the fulfillment of certain equity conditions, or, at the Company’s option, in cash.

The Company has the right to redeem the notes with restricted cash or any other cash of the Company, at its option, at any time after the earlier of March 31, 2017 or such time as at least $18 million of restricted cash shall have become unrestricted cash under the terms of the Notes.

Roth Capital Partners acted as sole placement agent for the offering.

"This committed financing provides us with the resources to advance our clinical development plan through the end of 2017 while also supporting our commercialization programs in Europe," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and Chief Executive Office of Delcath. "We are positioned to achieve important clinical inflection points in our FOCUS trial and our global Phase 2 program in HCC and ICC, which we believe represent the fastest path to U.S. FDA approval and ultimately the generation of shareholder value. This financing will be valuable to our efforts to expand global access to our Melphalan/HDS for the benefit of patients suffering with primary and metastatic liver cancers."

In addition to the Notes, the Company will issue common stock purchase warrants in a quantity equal to 85% of the number of shares of common stock the institutional investor would receive if the Notes were converted in full at the initial Conversion Price on the closing date (without regards to any limitations on conversion set forth therein). The warrants will be initially exercisable one year after their initial issuance date and expire five years thereafter. The warrants will include a one-time, downward-only reset of the warrant exercise price based on the market price on the maturity date, and for 75% of the warrants a corresponding adjustment of the number of warrant shares such that the aggregate exercise price of the warrants remains the same after the reset.

For additional information concerning the details of the financing, please refer to the Form 8-K to be filed by Delcath with the Securities and Exchange Commission.

The Notes, warrants and shares of common stock issuable upon conversion or exercise thereof have not been registered under the Securities Act or any applicable state securities laws and may not be offered or sold absent such registration or pursuant to an available exemption from such registration requirements. This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities nor shall there be any sale of any of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.

On June 7, 2016 Sorrento Therapeutics, Inc. (NASDAQ: SRNE) ("Sorrento"), an antibody-centric, clinical-stage biopharmaceutical company developing new treatments for cancer and other unmet medical needs, reported its subsidiary TNK Therapeutics, Inc. ("TNK") has entered into a joint venture agreement ("JVA") with Shenyang Sunshine Pharmaceutical Company Ltd ("3SBio") to develop and commercialize proprietary immunotherapies, including those developed from, including or using TNK’s chimeric antigen receptor T cell ("CAR-T") technology targeting carcinoembryonic antigen ("CEA") positive cancers (Press release, Sorrento Therapeutics, JUN 7, 2016, View Source [SID:1234513131]). 3SBio is a leading China-based biotechnology company focused on discovering, developing, manufacturing, and commercializing biopharmaceutical products.

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Under the terms of the JVA, 3SBio will make total contributions of $10 million to the joint venture and TNK will grant the joint venture an exclusive license to the CEA CAR-T technology and two additional CARs for cellular therapy for the Greater China market, including Mainland China, Hong Kong and Macau. 3SBio will initially own 51% of the joint venture while TNK will initially hold the remaining 49%.

"We are pleased that 3SBio, a leading biotechnology company in China, has recognized the value of our CAR-T technologies and we look forward to working with them to advance the development of our novel anti-cancer cellular therapies," said Dr. Henry Ji, President and CEO of Sorrento.

"3SBio is committed to introducing innovative biologic medicines for unmet medical needs in China and we look forward to collaborating with Sorrento to advance our CAR-T program into clinical trials in China. CAR-T technology is an important and promising approach to treating cancers, particularly for patients in advanced or metastatic stages of the disease. Our first candidate is aimed at CEA-positive cancers, which include colorectal, lung, liver and breast cancers," commented Dr. Jing Lou, Chairman and CEO of 3SBio.

On June 7, 2016 MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX), a clinical-stage oncology drug development company, reported the initiation of patient enrollment at Memorial Sloan Kettering Cancer Center (MSK) in the Phase I clinical trial evaluating its leading clinical development product MVT-5873 (HuMab-5B1) as a therapeutic treatment for patients with locally advanced or metastatic adenocarcinoma of the pancreas (PDAC) or other CA19-9 positive malignancies (Press release, MabVax, JUN 7, 2016, View Source [SID:1234513112]). This is the second investigational site in the Phase I trial with patient recruitment currently underway at the Sarah Cannon Research Institute in Nashville, TN. MabVax previously announced receipt of authorization to proceed on the Investigational New Drug (IND) application filed from U.S. Food and Drug Administration (FDA).

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The open-label, dose-escalation Phase I therapeutic trial is evaluating the safety, tolerability and pharmacokinetics of MVT-5873. The first group of patients are being enrolled to assess safety and determine the recommended phase II dose of the antibody. A second patient group will establish the safety and dose of the antibody when administered with a standard-of-care chemotherapy. Eileen O’Reilly, MD, Associate Director for Clinical Research at MSK’s David M. Rubenstein Center for Pancreatic Cancer Research, is serving as the lead investigator at the investigational site.

"We are very fortunate to have an established and productive relationship with MSK," said David Hansen, MabVax President and CEO. "With the addition of this investigational site, we are now recruiting patients in our Phase I therapeutics trial at two highly respected institutions. We continue on track to announce interim results from this trial in the third quarter of 2016."

About HuMab-5B1:

MabVax’s HuMab-5B1 antibody is fully human and was discovered from the immune response of cancer patients vaccinated with an antigen-specific vaccine during a Phase I trial at Memorial Sloan Kettering Cancer Center. In preclinical research, the 5B1 antibody has demonstrated high specificity and affinity, and has shown potent cancer cell killing capacity and efficacy in animal models of pancreatic, colon and small cell lung cancers. The antigen the antibody targets is expressed on more than 90% of pancreatic cancers making the antibody potentially broadly applicable to most patients suffering from this type of cancer. MabVax’s two lead antibody clinical programs utilize HuMab-5B1 as a naked antibody (MVT-5873) and as an immuno-PET imaging agent (MVT-2163).

On June 7, 2016 Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) ("Valeant" or the "Company") reported first quarter 2016 financial results and updated 2016 guidance (Press release, Valeant, JUN 7, 2016, http://ir.valeant.com/news-releases/2016/06-07-2016-110324216 [SID:1234513132]).

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"The first quarter’s results reflect, in part, the impact of significant disruption this organization has faced over the past nine months," said Joseph Papa, chairman and chief executive officer. "This has been a difficult period for Valeant and its stakeholders, and while there are some challenges to work through in certain business operations in 2016, such as our U.S. dermatology unit, the majority of our businesses are performing according to expectations.

"While we recognize that we did not meet the timeline for filing our first quarter results, with our filing expected this week, we will be current in our financial reporting," continued Papa. "We have made progress toward stabilizing the organization over the past few months, and we expect to file our financial results in a timely manner going forward. Valeant has a portfolio of world class brands, a strong new product pipeline and dedicated leaders who are committed to doing what is right and what is necessary to turn this company around by re-engaging our workforce, rebuilding our relationships with prescribers, patients and payors, and regaining the trust of our debtholders and shareholders."

Total Revenues
Total revenues increased $202 million, or 9%, to $2.37 billion in the first quarter of 2016, primarily due to the effect of acquisitions completed in 2015 and their subsequent growth under Valeant’s ownership. This increase was primarily offset by a negative foreign currency impact of $52 million and a negative impact from divestitures and discontinuations of $22 million. On an organic basis, total revenues declined $289 million in the first quarter of 2016 from the remainder of the existing business.

In the Developed Markets segment, revenues increased $186 million primarily from the acquisitions of Salix Pharmaceuticals, Ltd. (Salix) and certain assets of Dendreon Corporation and their subsequent growth under Valeant’s ownership of $513 million, primarily offset by declining volumes in the neurology portfolio and lower volumes in dermatology of $208 million.

In the Emerging Markets segment, revenues increased $15 million, primarily from the acquisition of Amoun Pharmaceutical Company S.A.E. of $59 million, partially offset by a negative foreign currency exchange impact.

Operating Expenses
Cost of goods sold, excluding amortization, as a percentage of product sales, increased to 27% for the first quarter of 2016 as compared to 24% for the first quarter of 2015 (restated) primarily due to an unfavorable foreign currency exchange impact in the first quarter of 2016, lower high-margin dermatology revenues due to changing market dynamics and the addition of lower margin products acquired in 2015, partially offset by increased margins in the neurology and other portfolio, as well as the addition of the Salix portfolio acquired in 2015.

Selling, general and administrative expenses ("SG&A") increased $239 million, or 42%, to $813 million in the first quarter of 2016. As a percentage of revenue, SG&A was 34% in the first quarter of 2016, as compared to 26% in the first quarter of 2015 (restated). SG&A in the first quarter of 2016 was impacted primarily by higher expenses related to acquisitions completed in 2015, as well as expenses related to share-based compensation costs and contractually required termination benefits for the Company’s former Chief Executive Officer, higher expenses to support the U.S. operations, and increased professional fees.

Investment in research and development increased $47 million, or 85%, to $103 million in the first quarter of 2016, primarily due to the development programs related to the Company’s dermatology product portfolio, including IDP-118, as well as brodalumab, an IL-17 receptor monoclonal antibody for patients with moderate-to-severe plaque psoriasis and psoriatic arthritis, and programs acquired in the Salix acquisition.

Net Income (Loss)
Net loss was $373.7 million, or a loss of $1.08 per diluted share for the first quarter of 2016 as compared to net income of $97.7 million, or $0.28 per diluted share in the first quarter of 2015 (restated). Adjusted net income (non-GAAP) was $442.6 million, or $1.27 per diluted share for the first quarter of 2016 as compared to adjusted net income (non-GAAP) of $704.2 million, or $2.05 per diluted share in the first quarter of 2015 (restated).

Cash Flow
GAAP cash flow from operations was $558 million in the first quarter of 2016 as compared to $491 million in the prior year, an increase of 14%.

2016 Guidance
The Company is updating its full year 2016 guidance. Total revenue is expected to be in the range of $9.9 – $10.1 billion. Adjusted EPS (non-GAAP) is expected to be in the range of $6.60 – $7.00. Adjusted EBITDA (non-GAAP) is expected to be in the range of $4.80 – $4.95 billion.