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Share Name | Share Symbol | Market | Type | Share ISIN | Share Description |
---|---|---|---|---|---|
Tiziana Life Sciences Plc | LSE:TILS | London | Ordinary Share | GB00BKWNZY55 | ORD 3P |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 58.50 | 45.00 | 60.00 | 0.00 | 01:00:00 |
Industry Sector | Turnover | Profit | EPS - Basic | PE Ratio | Market Cap |
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0 | 0 | N/A | 0 |
TIDMTILS
RNS Number : 8921F
Tiziana Life Sciences PLC
23 May 2017
Tiziana Life Sciences plc
("Tiziana" or "the Company")
Financial Results for the Year Ended 31 December 2016
Strong progress continues across clinical and pre-clinical programmes
London, 23 May 2017 - Tiziana Life Sciences plc ("Tiziana", AIM: TILS), a clinical stage biotechnology company developing targeted drugs for cancer and autoimmune diseases, today announces its financial results for the year ended 31 December 2016.
Highlights during the period:
RESEARCH & DEVELOPMENT
-- Foralumab
- A key milestone achieved with foralumab as new data demonstrated oral efficacy in humanized mouse models.
- Clinical development plan for foralumab outlined with initial focus in two clinical indications: graft vs host disease and non-alcoholic steatohepatitis (NASH).
-- Milciclib
- Continuing to progress through phase II trials for thymic carcinoma (thymoma) in patients previously treated with chemotherapy.
-- TZLS-101
- Research agreement with Cardiff University, focused on developing Bcl-3 inhibitors as potential drugs to treat cancer, has led to the identification of a first-in-class lead clinical candidate, CB1, with potent anti-metastatic activity, and with an impressive in vivo efficacy and safety profile.
- Partnership recognised as the winner of the Innovation in Healthcare category at Cardiff University's Innovation and Impact Awards 2016.
-- TZLS-214 / c-FLIP - Currently under analysis to identify a lead candidate. -- StemPrinter - Currently under analysis with more operational details expected later this year. -- LonGevia
- Unique bio-repository of local samples and data from Sardinian company Shardna SpA acquired in July 2016.
- Residents of Sardinia are among the world's longest living people, with on average 5x greater likelihood of reaching age 100 compared with the USA.
- The Group has established LonGevia Genomics Srl, a regional subsidiary specifically to develop these assets to identify novel drug targets and diagnostic applications.
LEADERSHIP
-- Highly experienced executives joined senior leadership team and Scientific Advisory Board:
- Tiziano Lazzaretti appointed as Chief Financial Officer, formerly Group Finance Director at Pharmentis.
- Professors Kevan Herold and Howard Weiner joined the Scientific Advisory Board, providing key leadership and experience in CD3 clinical development.
FINANCIAL
-- GBP0.71m (gross) raised through a convertible loan note in January 2016.
-- In April 2016 and June 2016, Tiziana received notice from warrant holders to exercise warrants raising GBP0.22m and GBP0.07m respectively.
-- For the year to 31 December 2016 the consolidated Group made a loss of GBP7.21m (2015: GBP8.63m).
-- The Group ended the period with GBP4.70m cash as at 31 December 2016 (2015: GBP8.90m).
POST PERIOD
-- TZLS-501 (Anti-IL6R)
- Exclusive world-wide licence for NI-1201 (now TZLS-501), a fully human anti-interleukin-6 receptor (IL-6R) monoclonal antibody (mAb), acquired from Novimmune SA.
- Currently in pre-clinical development for multiple myeloma. -- Dr. Arun Sanyal appointed as a new member of the Scientific Advisory Board.
Gabriele Cerrone, Chairman and founder, commented: "We are proud of our achievements over the last twelve months. We have continued to make progress with our pipeline of drugs, which now addresses several areas of unmet medical need in both cancer and autoimmune diseases. In particular, we have outlined our clinical development plan for foralumab in graft vs host disease and NASH; and we are making good progress with milciclib, which is currently in phase II clinical trials for thymic carcinoma in patients previously treated with chemotherapy, and for hepatocellular carcinoma. 2017 is set to be an important year for Tiziana and the Board remains confident of being well positioned to progress these programmes to their next respective value inflection points."
Contacts
Tiziana Life Sciences plc Gabriele Cerrone, Chairman and founder +44 (0)20 7493 2853 Cairn Financial Advisers LLP (Nominated adviser) +44 (0)20 7213 Liam Murray / Jo Turner 0880 Beaufort Securities Limited (Broker) Saif Janjua +44 (0)20 7382 8300 FTI Consulting Simon Conway / Natalie Garland-Collins +44 (0)20 3727 1000
About Tiziana Life Sciences
Tiziana Life Sciences plc is a UK biotechnology company that focuses on the discovery and development of novel molecules that treat human disease in oncology and immunology. The Company is focused on its lead compound Milciclib. The Company is also in clinical development of foralumab. Foralumab is the only fully human engineered anti-human CD3 antibody in clinical development. This phase II compound has potential application in a wide range of autoimmune and inflammatory diseases, such as nonalcoholic steatohepatitis (NASH), primary biliary cholangitis (PBS), ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable.
For more information go to http://www.tizianalifesciences.com
This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.
EXECUTIVE CHAIRMAN'S STATEMENT
I am pleased to report on the Company and its subsidiaries, together the 'Group', results for the year ended 31(st) December 2016.
Background
Tiziana Life Sciences plc is a UK AIM-listed biotechnology company (AIM:TILS) focused on the discovery and development of next generation therapeutics for cancers and immune diseases in man. The Group combines field-leading medical scientists, providing deep knowledge and novel insights into disease mechanisms, together with a highly experienced clinical development team. Since its foundation in 2013, Tiziana Life Sciences has expanded its pipeline of assets to include clinical stage development therapeutic candidates in both oncology and immunology, as well as a pre-clinical drug discovery pipeline of small molecule New Chemical Entities.
Clinical Programmes
The Group's approach is to target large markets with high-unmet medical need. Driven by an obesity epidemic, non-alcoholic fatty liver disease (NAFLD) has become the most common liver disease, affecting one-third of the Western world. Between 3 and 5% of patients progress to a more severe form of disease, non-alcoholic steatohepatitis (NASH), which is predicted to become the leading cause of liver transplantation in USA by 2020.
The race for therapeutics that address the market for NASH, which is estimated to reach GBP16.2 billion by 2025 (10.7% CAGR from 2015 to 2025), has led to a flurry of acquisitive activity in 2016 with four announced deals, totalling more than GBP2.3 billion in value. Around 20% of NASH patients progress further to cirrhosis of the liver, which may ultimately develop into lethal hepatocellular carcinoma (HCC), the primary cause of obesity-related cancer death in middle-aged men in the USA. No currently approved drugs for HCC exist - liver transplant being the only option for end-stage patients.
Tiziana Life Sciences has two lead clinical programmes:
Foralumab (TZLS-401 / NI-0401)
Foralumab is a fully human engineered anti-CD3 monoclonal antibody (mAB). It was in-licensed in December 2014 from Novimmune. Also in January 2016, Tiziana outlined its clinical development plan for foralumab with initial plans to evaluate foralumab in two clinical indications: non-alcoholic steatohepatitis (NASH) and graft vs host disease (GvHD).
As the only fully human engineered anti-human CD3 mAB in clinical development, foralumab has significant potential with advantages of short duration of treatment regimen and reduced immunogenicity. With phase IIa development for Crohn's Disease completed, modulation of T-cell response provides potential extension into a wide range of other autoimmune and inflammatory diseases, such as GvHD, ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis.
Foralumab is being developed as both an immunosuppressive and immunomodulatory agent, with therapeutic benefits of rendering T-cells unable to orchestrate an immune response and induction of immune tolerance via maintenance of regulatory T-cells. There is further potential for foralumab to be combined with another of the Group's assets, TZLS-501, a fully human anti-IL-6R mAB in development to target Crohn's disease, NASH and primary biliary cholangitis (PBC).
In November 2016, the Group announced new data for oral efficacy in humanized mouse models with foralumab, a major milestone and a potential breakthrough for treatment of NASH and autoimmune disease. This unique oral technology stimulates the natural gut immune system and potentially provides a therapeutic effect in inflammatory and autoimmune diseases with apparently greatly reduced toxicity. Positive therapeutic effects with foralumab were consistently demonstrated in animal studies conducted by Prof. Kevan Herold (Yale University) and Prof. Howard Weiner (Harvard University).
Milciclib (TZLS-201)
Milciclib, the Group's lead compound, was exclusively licensed in January 2015 from Nerviano Medical Sciences. Milciclib blocks the action of a set of enzymes called cyclin-dependent kinases (CDKs) involved in cell division processes that are key to the progression of cancers.
Prior to in-licensing, Milciclib has demonstrated that it is well tolerated in over 263 patients in phase I and II clinical trials and has been granted orphan designation by the European Commission and by the U.S. Food and Drug Administration ("FDA") for the treatment of malignant thymoma / thymic epithelial tumours. Milciclib is currently in phase II clinical trials for thymic carcinoma (thymoma) in patients previously treated with chemotherapy, and for hepatocellular carcinoma.
Pre-Clinical Programmes
In pre-clinical development, the Group has two programmes:
TZLS-501 (Anti-IL6R)
TZLS-501 is a fully human anti IL-6R monoclonal antibody, acquired from Novimmune, with a novel mechanism of action targeting multiple myeloma. The mAb possesses a high affinity for IL-6R and the IL-6/IL-6R complex and effectively blocks the complex even at high IL-6 circulating levels, showing superiority and overcoming the limitations of other IL-6 pathway drugs. Therefore, TZLS-501 demonstrates a decreased potential for adverse events with improved efficacy in patients with high circulating levels of IL-6 and controlling chronic inflammation in diseases such as multiple myeloma, rheumatoid arthritis and other autoimmune diseases.
StemPrinter
StemPrinter, a diagnostic kit for triple negative breast cancer, is currently under analysis, with more details expected later this year.
Other early-stage therapeutic and diagnostic technologies under evaluation
TZLS-101
In January 2016, the Group announced that its research agreement with Cardiff University, focused on pioneering the development of Bcl-3 inhibitors as potential drugs to treat cancer, has led to the identification of a first-in-class lead clinical candidate, CB1 (TZLS-101), with potent anti-metastatic activity, and with an impressive in vivo efficacy and safety profile. Metastatic spreading of cancers is the single most important cause of their high mortality. This partnership was recognised as the winner of the Innovation in Healthcare category at Cardiff University's Innovation and Impact Awards 2016.
TZLS-214
Tiziana's novel anti-cancer stem cell agent, TZLS-214 / c-FLIP is currently under analysis.
LonGevia
In July 2016, Tiziana acquired a unique bio-repository of local samples and data from a Sardinian company, Shardna SpA. Residents of Sardinia are among the world's longest living people, with on average five times greater likelihood of reaching age 100 compared with the USA. The Group has established LonGevia Genomics Srl, a regional subsidiary specifically to develop these assets to identify novel drug targets and diagnostic applications through leveraging next generation gene sequencing and state of the art "-omics" technologies.
Financial summary
Consolidated Statement of Comprehensive Income
The Group has made a loss for the year of GBP7,208k (2015: GBP8,632k). The loss is detailed in the consolidated statement of comprehensive income.
Consolidated Statement of Financial Position
At the end of the year the Group cash balance amounted to GBP4,703,367 (2015: GBP8,903,000) and the total assets of the Group amounted to GBP5,051,148 (2015: GBP9,250,000).
Fund raising
In the period, the Group successfully raised funds to further progress its on-going clinical trials and give the Group the resources to expand its presence internationally.
On 13(st) January 2016, Tiziana entered into an agreement to issue GBP709,407 of Investor Convertible Loan Notes: Tranche F through the issue of 472,938 unsecured convertible loan notes. The notes are redeemable by the holders at any time after 31 December 2016 and will be redeemed, at the election of the Group, in cash or by conversion into new ordinary shares in the Group at a conversion price of GBP1.50 per share.
On 18(th) April 2016 and 28(th) June 2016, Tiziana received notice from warrant holders to exercise warrants raising GBP219,000 and GBP66,000 respectively.
Funds raised by Tiziana will be used to fund the development of the Group's clinical stage assets, Milciclib and foralumab, to meet the Group's ongoing liabilities in respect of licence agreements, and for general working capital purposes.
Research & Development
In January 2016, the Company announced that its research agreement with Cardiff University, focused on pioneering the development of Bcl-3 inhibitors as potential drugs to treat cancer, has led to the identification of a first-in-class lead clinical candidate, CB1 (TZLS-101), with potent anti-metastatic activity, and with an impressive in vivo efficacy and safety profile. This partnership was recognised as the winner of the Innovation in Healthcare category at Cardiff University's Innovation and Impact Awards 2016. Tiziana intends to file an Investigational New Drug (IND) application for CB1 and expects to move this drug candidate into clinical trials shortly thereafter.
Also in January 2016 Tiziana outlined its clinical development plan for foralumab with initial plans to evaluate foralumab in two clinical indications; namely, graft vs host disease and non-alcoholic steatohepatitis (NASH). Foralumab is the only fully human anti-CD3 monoclonal antibody currently in development for the modulation of autoimmune disease.
The Company's small molecule drug candidate, milciclib, continues to progress through phase II trials for thymic carcinoma (thymoma) in patients previously treated with chemotherapy.
Tiziana's novel anti-cancer stem cell agent, TZLS-214 / c-FLIP is currently under analysis. StemPrinter is also currently under analysis with more detailed expected later this year.
In July 2016, Tiziana acquired a unique bio-repository of local samples and data from Sardinian company Shardna SpA. Residents of Sardinia are among the world's longest living people, with on average five times greater likelihood of reaching age 100 compared with the USA. The Company has established LonGevia Genomics Srl, a regional subsidiary specifically to develop these assets to identify novel drug targets and diagnostic applications through leveraging next generation gene sequencing and state of the art "-omics" technologies.
Appointments
Management team
On 4 April 2016, Tiziano Lazzaretti was appointed as Chief Financial Officer, taking over from Phil Boyd, who tendered his resignation on 7th May 2015 in order to focus on other opportunities.
Mr Lazzaretti has extensive experience in the healthcare and pharmaceutical industry and joins Tiziana from Pharmentis Srl, an Italian pharmaceutical business, where he served as Group Finance Director since 2011. Prior to this, Mr Lazzaretti held senior roles at Alliance Boots Healthcare, Accenture and other listed companies such as SNIA Spa and Fiat Group. He has a Bachelor of Science (BSc hons) in Accounting and Finance from the University of Turin, Italy and was awarded a Master in Business Administration (MBA) from Bocconi University, Milan.
Scientific Advisory Board
On 11 January 2016, the Group announced the addition of two key members to the Scientific Advisory Board: Professors Kevan Herold, MD and Howard Weiner, MD.
Dr. Kevan Herold
Dr. Kevan Herold is Professor of Immunobiology and of Medicine (Endocrinology) as well as Deputy Director, Yale Center for Clinical Investigation, Director of the Yale Diabetes Center and Director of the TrialNet Center at Yale. His investigative work has focused on developing new ways to prevent and treat autoimmune diseases, using novel translational immunologic and metabolic approaches to prevent progression, in particular anti-CD3 monoclonal antibody therapy. His clinical interests are in the management of endocrine diseases, and he is involved in a number of national and international clinical studies of new treatments.
Dr. Howard Weiner
Dr. Howard Weiner is the Robert L. Kroc Professor of Neurology at the Harvard Medical School, Director and Founder of the Partners Multiple Sclerosis (MS) Center and Co-Director of the Ann Romney Center for Neurologic Diseases at Brigham & Women's Hospital in Boston. The Partners MS Center is the first integrated MS Center that combines clinical care, MRI imaging and immune monitoring to the MS patient as part of the 2000 patient CLIMB cohort study. He has pioneered immunotherapy in MS and has investigated immune mechanisms in nervous system diseases including MS, Alzheimer's disease, amyotrophic lateral sclerosis, stroke and brain tumours. He has also pioneered the investigation of the mucosal immune system for the treatment of autoimmune and other diseases and the use of anti-CD3 to induce regulatory T cells for the treatment of these diseases.
Outlook
It has been a busy twelve months for the Group as we have bolstered our senior leadership team and Scientific Advisory Board, and continued to progress our pipeline of drugs to treat rare cancers and difficult to treat autoimmune inflammatory diseases.
We have outlined our clinical development plan for foralumab with initial plans to evaluate foralumab in two clinical indications: graft vs. host disease and NASH. Milciclib is currently in phase II clinical trials for thymic carcinoma (thymoma) in patients previously treated with chemotherapy, and for hepatocellular carcinoma.
Looking forward, we are confident of being well positioned to progress these programmes to their next respective value inflection points.
Gabriele Cerrone
Executive Chairman
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
FOR THE YEARED 31 DECEMBER 2016
2016 2015 Continuing Operations GBP'000 GBP'000 Research and development costs (2,956) (6,287) Operating expenses (4,332) (2,327) Operating loss (7,288) (8,614) Finance costs (9) (18) Loss before taxation (7,297) (8,632) Taxation 89 - Loss for the year attributable to equity owners (7,208) (8,632) ========== ========== Other comprehensive income - - Total comprehensive loss for the year attributable to equity owners (7,208) (8,632) ========== ========== Loss per share Basic and diluted (loss) per share on continuing operations (7.7p) (9.5p) ========== ==========
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
FOR THE YEARED 31 DECEMBER 2016
2016 2015 GBP'000 GBP'000 ASSETS Non-Current assets Property, plant and equipment 28 - Total Non-current assets 28 - --------- --------- Current assets Other receivables 103 347 Other current assets 217 - Cash and cash equivalents 4,703 8,903 --------- --------- Total current assets 5,023 9,250 --------- --------- TOTAL ASSETS 5,051 9,250 ========= ========= EQUITY AND LIABILITIES Equity Capital and reserves attributable to equity holders of the company Called up share capital 2,832 9,375 Share premium 2,071 20,632 Share based payment reserve 1,935 1,008 Shares to be issued reserve (warrants) 191 102 Shares to be issued reserve 13,535 12,287 Merger relief reserve - 5,625 Other reserve (28,286) (28,286) Capital redemption reserve - - Retained earnings 11,036 (12,239) Total equity 3,314 8,504 Liabilities Current liabilities Trade and other payables 1,737 746 1,737 746 --------- --------- TOTAL EQUITY AND LIABILITIES 5,051 9,250 ========= =========
CONSOLIDATED STATEMENT OF CASH FLOWS
FOR THE YEARED 31 DECEMBER 2016
2016 2015 GBP'000 GBP'000 Cash flows from operating activities Total comprehensive loss for the period before taxation (7,208) (8,632) Convertible loan interest accrued 9 - Share based payment - options 927 972 Share based payment - warrants 89 102 Net (increase)/decrease in operating assets/other receivables 0 (153) Net increase/(decrease) in operating liabilities /other liabilities 866 63 Depreciation 8 - Other share based payments - 2,138 Loss on foreign exchange 158 - Lease adjustment 41 - NET CASH USED IN OPERATING ACTIVITIES (5,110) (5,510) Cash flows from financing activities Proceeds from issuance of ordinary shares 453 2,638 Proceeds from issuance of convertible loan notes 709 10,235 Fundraising cost - (726) NET CASH GENERATED FROM FINANCING ACTIVITIES 1,162 12,147 Cash flows from investing activities Acquisition of property, plant and equipment (35) - Acquisition of other investments (217) NET CASH GENERATED FROM INVESTING ACTIVITIES (252) - NET INCREASE/(DECREASE) IN CASH AND CASH EQUIVALENTS (4,200) 6,637 Cash and cash equivalents at beginning of year 8,903 2,266 CASH AND CASH EQUIVALENTS AT OF YEAR 4,703 8,903 ========= ========= CONSOLIDATED STATEMENT OF CHANGES IN EQUITY FOR THE YEARED 31 DECEMBER 2016 Share Share Merger Capital Share Restated Convertible Other Retained Total Capital Premium Relief Redemption Based Shares Loan Reserve Earnings Equity Reserve Reserve Payment To Note Reserve Be Reserve Issued Reserve GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 Balance at 1 January 2015 9,144 16,294 5,625 - 146 - 2,259 (28,286) (3,405) 1,777 Transactions with owners Issue of share capital under share-based payment scheme 231 4,338 - - - - - - - 4,569 Share based payment (options) - - - - 972 - - - - 972 Share based payment (warrants) - - - - - 102 - - - 102 Convertible loan note - equity component - - - - - - 10,028 - (312) 9,716 Options cancelled in the year - - - (110) - - - 110 - Total transactions with owners 9,375 20,632 5,625 - 862 102 10,028 - (202) 15,539 Comprehensive income Comprehensive loss for the year - - - - - - - - (8,632) (8,632) Total comprehensive income Balance as at 31 December 2015 9,375 20,632 5,625 - 1,008 102 12,287 (28,286) (12,239) 8,504 Transactions with owners Issue of share capital under share-based payment scheme 61 393 - - - - - - - 454 Share based payment (options) - - - - 927 - - - - 927 Share based payment (warrants) - - - - - 89 - - - 89 Convertible loan note - equity component - - - - - - 1,248 - (690) 558 Options - - - - - - - - - - cancelled in the year Cancellation of deferred shares (6,604) - - 6,604 - - - - - - Capital reduction - (18,954) (5,625) (6,604) - - - - 31,183 - Prior year adjustments - - - - - - - - (10) (10) - -------- --------- -------- ----------- -------- --------- ------------ --------- ---------- -------- Total transactions with owners (6,543) (18,561) (5,625) - 927 191 1,248 - 30,483 2,018 Comprehensive income Comprehensive loss
for the year - - - - - - - - (7,208) (7,208) -------- ----------- Total comprehensive income - - - - - - - - (7,208) (7,208) -------- ----------- Balance as at 31 December 2016 2,832 2,071 - - 1,935 191 13,535 (28,286) 11,036 3,314 ---------------- -------- --------- -------- ----------- -------- --------- ------------ --------- ---------- --------
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
1. General Information
The financial information set out above does not constitute the Company's statutory accounts for the years ended 31 December 2016 or 2015 but is derived from those accounts. Statutory accounts for 2015 have been delivered to the registrar of companies, and those for 2016 will be delivered in due course. The auditors have reported on those accounts; their reports were (i) unqualified, (ii) did not include a reference to any matters to which the auditors drew attention by way of emphasis without qualifying their report and (iii) did not contain a statement under section 498 (2) or (3) of the Companies Act 2006.
2. Loss per Share
Basic loss per share is calculated by dividing the profit attributable to equity holders of the company by the weighted average number of ordinary shares in issue during the year.
2016 2015 (Loss) attributable to equity holders of the company (GBP) (7,207,597) (8,632,226) Weighted average number of ordinary shares in issue 93,592,195 91,242,884 Basic loss per share (pence per share) (7.7) (9.5) ============ ============
As the Group is reporting a loss from continuing operations for the year then, in accordance with IAS 33, the share options are not considered dilutive because the exercise of the share options would have an anti-dilutive effect. The basic and diluted earnings per share as presented on the face of the income statement are therefore identical. All earnings per share figures presented above arise from continuing and total operations and therefore no earnings per share for discontinued operations are presented.
3. Availability of Report and Accounts and Notice of Annual General Meeting
The Company has posted its audited Report and Accounts to 31 December 2016 and Notice of AGM to shareholders. The AGM will be held at the offices of Cooley (UK) LLP, Dashwood, 69 Old Broad Street, London EC2M 1QS on 29 June at 10.30 a.m. A copy of the Report and Accounts and Notice of AGM is available to be downloaded from the Company's website at www.tizianalifesciences.com.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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(END) Dow Jones Newswires
May 23, 2017 02:00 ET (06:00 GMT)
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