NanOlogy to Present Abstract on Preclinical Study of Nebulized NanoPac for Lung Cancer at 2018 ASCO Annual Meeting

On April 25, 2018 NanOlogy LLC, a clinical-stage pharmaceutical development company, reported that it will present an abstract detailing results of a preclinical trial of a nebulized form of NanoPac (submicron particle paclitaxel) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2018 Annual Meeting in Chicago, June 1 – 5 (Press release, NanOlogy, APR 25, 2018, View Source [SID1234525695]).

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The abstract, "NanoPac Inhalation Treatment of NSCLC in a Nude Rat Orthotopic Lung Cancer Model," will be presented Sunday, June 3, 8 am to 11:30 am, in Hall A of the McCormick Place.

NanOlogy is currently conducting Phase 2 clinical trials of NanoPac sterile suspension for ovarian cancer (with orphan drug designation), prostate cancer, pancreatic cancer and pancreatic mucinous cysts.

In addition, NanOlogy and affiliate, DFB Soria, are progressing clinical trials of Soria-developed SOR007, a topical ointment form of NanoPac for cutaneous metastases and actinic keratosis. Clinical trials for NanoDoce, (submicron particle docetaxel) are planned in 2018 pending IND approval.

The NanOlogy submicron particle technology platform is based on a patented production process that reduces the size of paclitaxel and docetaxel API crystals by up to 400 times into patent-pending, stable, naked submicron particles with exponentially increased surface area and unique geometry. The technology enables delivery of concentrated doses of paclitaxel and docetaxel directly into the disease site without the serious adverse side effects associated with systemic infusions of the chemotherapy.

Adaptimmune to Report First Quarter 2018 Financial Results and Business Update on Wednesday May 9, 2018

On April 25, 2018 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported that it will announce financial results for the First Quarter 2018 and provide a general business update before the open of the U.S. markets on Wednesday May 9, 2018 (Press release, Adaptimmune, APR 25, 2018, View Source;p=RssLanding&cat=news&id=2344498 [SID1234525678]). Following the announcement, the company will host a live teleconference and webcast at 8:00 a.m. EDT (1:00 p.m. BST) on the same day.

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The press release and the live webcast of the conference call will be available in the investor section of Adaptimmune’s corporate website at www.adaptimmune.com. An archive will be available after the call at the same address.

To participate in the live conference call, if preferred, please dial (833) 652-5917 (U.S.) or (430) 775-1624 (International). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (2967789).

NewLink Genetics Announces Presentation of Abstracts at ASCO 2018 Annual Meeting

On April 25, 2018 NewLink Genetics Corporation (NASDAQ:NLNK) today reported that two abstracts pertaining to the company’s indoximod program will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2018 Annual Meeting in Chicago (Press release, NewLink Genetics, APR 25, 2018, View Source [SID1234525696]).

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Poster Discussion Session: Poster Board #204 – Abstract 4015 – Phase 2 trial of the IDO pathway inhibitor indoximod plus gemcitabine / nab-paclitaxel for the treatment of patients with metastatic pancreas cancer – to be presented during the discussion session, "Gastrointestinal (Noncolorectal) Cancer," Sunday, June 3, 2018, 4:45 PM – 6:00 PM CT

Poster Discussion Session: Poster Board #339 – Abstract 9512 – Phase 2 trial of the IDO pathway inhibitor indoximod plus checkpoint inhibition for the treatment of patients with advanced melanoma – to be presented during the discussion session, "Melanoma/Skin Cancers," Monday, June 4, 2018, 4:45 PM – 6:00 PM CT

The complete text of abstracts selected for presentation at the ASCO (Free ASCO Whitepaper) 2018 Annual Meeting will be posted to the ASCO (Free ASCO Whitepaper) website on Wednesday, May 16th at 5pm ET.

"We are pleased to have the opportunity to present the results at ASCO (Free ASCO Whitepaper) from both of these Phase 2 trials of indoximod in combination therapies for patients with pancreatic cancer and advanced melanoma. We continue to gather data supporting the potential for our differentiated IDO pathway inhibitor, indoximod, in multiple combinations to improve the lives of patients with cancer," said Nicholas N. Vahanian, MD, President.

About Indoximod

Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is a key immuno-oncology target involved in regulating the tumor microenvironment and immune escape. Indoximod is being evaluated in combination with treatment regimens including anti-PD-1/PD-L1 agents, chemotherapy, radiation and cancer vaccines across multiple indications such as melanoma, pancreatic cancer and other malignancies.

GSK delivers Q1 sales of £7.2 billion, -2% AER, +4% CER
Total EPS 11.2p, -48% AER, -33% CER; Adjusted EPS 24.6p, -2% AER, +11% CER
Significant currency impact in the quarter reflecting movements in Sterling

On April 25, 2018 GlaxoSmithKline reported financial highlights for the first quarter of 2018 (Press release, GlaxoSmithKline, APR 25, 2018, View Source [SID1234525740]).

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• CER sales growth across all 3 businesses. Pharmaceuticals sales £4.0 billion -4% AER, +2% CER;
Vaccines £1.2 billion +7% AER, +13% CER; Consumer Healthcare £2.0 billion -3% AER, +2% CER
• Adjusted Group operating margin of 26.6%, down 0.2 percentage points AER, up 1.3 percentage points
CER. Pharmaceuticals 33.2%; Vaccines 27.4%; Consumer Healthcare 19.4%
• Total EPS 11.2p, -48% AER, -33% CER, reflecting revaluation of Consumer Healthcare business
following agreement to acquire full ownership
• Adjusted EPS 24.6p, -2% AER, +11% CER driven by continued operating and financial efficiencies
• Q1 free cash flow £324 million -50% primarily reflecting impact of £317 million Vaccine sales milestone
payment to Novartis
• 19p dividend declared for quarter. Continue to expect 80p for FY 2018
• Guidance for CER growth in Adjusted EPS for 2018 maintained
Novartis transaction
• Agreement reached with Novartis to acquire full ownership of Consumer Healthcare business for
$13 billion, subject to shareholder approval
Product and pipeline highlights
• Sales of Ellipta Respiratory products, £386 million +25% AER, +34% CER and Nucala £104 million
+76% AER, +86% CER. Landmark IMPACT data for Trelegy Ellipta published in NEJM. sNDA
approved in US and data submitted to European Medicines Agency to support expanded label.
OSMO study demonstrating Nucala improves asthma control in severe eosinophilic asthma patients
uncontrolled on Xolair presented at AAAAI
• Continued growth from dolutegravir-based HIV products, including new 2 drug regimen Juluca, with
sales of £964 million +15% AER, +23% CER. Positive CHMP opinion received for Juluca in Europe
• Shingrix sales of £110 million; approved in Europe and Japan (23 March)

Emma Walmsley, Chief Executive Officer, GSK said:
"GSK has continued to make good progress in the first quarter with sales growth on a CER basis across all
three businesses. We are strongly focused on commercial execution with encouraging starts for our most
recent new product launches, Shingrix, Trelegy and Juluca. This performance combined with continued cost
discipline has driven a further improvement in the Group’s Adjusted operating margin at CER. We also agreed
to acquire full ownership of the Consumer Healthcare business during the quarter, delivering on one of our key
capital allocation priorities. This will help improve future cash generation and support capital planning for the
Group’s main priority to strengthen the Pharmaceuticals business and R&D pipeline.

2018 guidance
The Group expects to make continued progress in 2018, although the expectation for Adjusted EPS growth
is impacted by a number of factors including, in particular, uncertainties relating to the timing and extent of
potential generic competition to Advair in the US.
In the event that no substitutable generic competitor to Advair is introduced to the US market in 2018, the
Group continues to expect 2018 Adjusted EPS growth of 4 to 7% at CER. In the first quarter, the Group has
made continued progress, with encouraging performances from new launches, Shingrix, Trelegy and Juluca
and other new products, as well as agreeing the buyout of Novartis’ shareholding in the Consumer Healthcare
Joint Venture, subject to shareholder approval. However, the Group has also seen increased pricing and
competitive pressures in the US inhaled respiratory market in the first quarter, and GSK now expects a decline
in 2018 US Advair sales of around 30% at CER.
In the event of a mid-year introduction of a substitutable generic competitor to Advair in the US, the Group
expects full year 2018 US Advair sales of around £750 million at CER (US$1.30/£1), with Adjusted EPS
flat to down 3% at CER.
The effective tax rate for 2018 is expected to be approximately 19-20% of Adjusted profits after the impact
of US tax reform which is expected to benefit the Group effective tax rate by two to three percentage points.
GSK is not able to give guidance for Total results as it cannot reliably forecast certain material elements of
our Total results such as the future fair value movements on contingent consideration and put options. It
should be noted that contingent consideration cash payments are made each quarter primarily to Shionogi by
ViiV Healthcare which reduce the balance sheet liability and are hence not recorded in the income statement.
An explanation of the acquisition-related arrangements with ViiV Healthcare, including details of cash
payments to Shionogi, is set out on page 37.
If exchange rates were to hold at the closing rates on 31 March 2018 ($1.40/£1, €1.14/£1 and Yen 149/£1)
for the rest of 2018, the estimated negative impact on full-year 2018 Sterling turnover growth would be around
5% and if exchange gains or losses were recognised at the same level as in 2017, the estimated negative
impact on 2018 Sterling Adjusted EPS growth would be around 8%

Agilent Technologies to Host Webcast of Second-Quarter Fiscal Year 2018 Financial Results Conference Call

On April 25, 2018 Agilent Technologies Inc. (NYSE: A) reported that it will release second-quarter fiscal 2018 financial results after the stock market closes on May 14 (Press release, Agilent, APR 25, 2018, http://www.agilent.com/about/newsroom/presrel/2018/25apr-gp18036.html [SID1234525679]). The company will host a live webcast of its investor conference call in listen-only mode.

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Date: Monday, May 14, 2018
Time: 1:30 PM (Pacific Time)
Web access: http://www.investor.agilent.com

Listeners may log on and select "Q2 2018 Agilent Technologies Inc. Earnings Conference Call" in the "News & Events — Calendar of Events" section. The webcast will remain on the company site for 90 days.

In addition, a telephone replay of the conference call will be available at approximately May 14, 2018 at 4:30 PM (Pacific Time) after the call and through May 21 by dialing +1 855-859-2056 (or +1 404-537-3406 from outside the United States) and entering pass code 7398497.