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Eutelsat to Dispose of Its Interest in Euro Broadband Infrastructure

Eutelsat to Dispose of Its Interest in Euro Broadband Infrastructure

  • Completing the reorganisation of broadband distribution in Europe
  • Preparing for commercialization of EUTELSAT KONNECT and KONNECT VHTS satellites

PARIS–(BUSINESS WIRE)–
Regulatory News:

Eutelsat Communications (Paris:ETL) (Euronext Paris: ETL) has agreed the disposal of its 51% stake in Euro Broadband Infrastructure (EBI), the company operating the KA SAT satellite, and related European broadband business to Viasat Inc, its 49% shareholder, for an initial consideration of €140m.

The transaction completes the reorganization and simplification of Eutelsat’s broadband distribution in Europe following the acquisition of Bigblu Broadband Europe, while moving towards an open technology and freeing up financial resources for investment in direct distribution.

Commenting on the deal, Rodolphe Belmer, Chief Executive Office of Eutelsat said: “We are delighted to reach this agreement with Viasat over the future of EBI. It completes the reorganization of our broadband distribution set-up for Europe following the wholesale agreement with Orange for France and the acquisition of Bigblu Broadband Europe covering other major markets. With the recent entry into service of EUTELSAT KONNECT, to be followed by the launch of KONNECT VHTS, we are optimally placed to assure the rapid ramp-up of these new generation in-orbit assets in the coming years.”

Under the agreement, Eutelsat and its subsidiaries will continue to provide transitional services to EBI, including the operation of the ground network for KA SAT, while EBI will provide service continuity to the KA SAT subscriber base of Bigblu Broadband Europe acquired by Eutelsat in September 2020.

The stake will be sold for an initial consideration of €140m, subject to a customary net working capital and net debt adjustments at the time of completion. Two years following completion, the consideration may be adjusted up or down by up to €20m depending on the level of certain EBI revenues achieved over this period. The transaction will also result in the deconsolidation by Eutelsat of the cash held by EBI of €90m at 30 September 2020.

Completion is expected in the first quarter of calendar year 2021, subject to customary conditions precedent.

The net impact of the combined operations of the acquisition of Bigblu Broadband Europe and the disposal of EBI is estimated at around -€20m on Operating Vertical Revenues and -€30m on Discretionary Free-Cash-Flow for the first full fiscal year following completion of the transactions.

As a reminder, FY 2020-21 Operating Vertical Revenues and FY 2021-22 Discretionary Free-Cash-Flow objectives are expressed at constant perimeter. Given the timing of closing of both transactions the impact on FY 2020-21 Operating Vertical Revenues will be limited and should be absorbed within the existing revenue objective at the close of the transaction.

About Eutelsat Communications

Founded in 1977, Eutelsat Communications is one of the world’s leading satellite operators. With a global fleet of satellites and associated ground infrastructure, Eutelsat enables clients across Video, Data, Government, Fixed and Mobile Broadband markets to communicate effectively to their customers, irrespective of their location. Over 6,600 television channels operated by leading media groups are broadcast by Eutelsat to one billion viewers equipped for DTH reception or connected to terrestrial networks. Headquartered in Paris, with offices and teleports around the globe, Eutelsat assembles 1,000 men and women from 46 countries who are dedicated to delivering the highest quality of service.

For more about Eutelsat go to www.eutelsat.com

Media

Joanna Darlington

Tel.: +33 1 53 98 31 07

[email protected]

Marie Sophie Ecuer

Tel.: +33 1 53 98 32 45

[email protected]

Jessica Whyte

Tel.: +33 1 53 98 46 21

[email protected]

Investors

Joanna Darlington

Tel.: +33 1 53 98 31 07

[email protected]

Cédric Pugni

Tel.: +33 1 53 98 31 54

[email protected]

Alexandre Illouz

Tel.: +33 1 53 98 46 81

[email protected]

KEYWORDS: France Europe

INDUSTRY KEYWORDS: Technology Internet Telecommunications Satellite

MEDIA:

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Realfiction announces its plan for completion of the ECHO integration license package

PR Newswire

STOCKHOLM, Nov. 19, 2020 /PRNewswire/ — Realfiction Holding AB (“Realfiction” and/or “the Company”) announces a completion phase including a potential further optimization for production which is expected to result in even lower manufacturing costs and a slimmer form factor. The completion phase is planned to last 13-16 months in collaboration with a couple of leading European research institutes and facilities. By spring 2021, Realfiction will also actively seek a co-development agreement with a commercial display manufacturer to speed up time to market.

As part of the ongoing ECHO development, Realfiction has identified a potential further reduction in complexity compared to competing technologies of a central component of the ECHO technology, namely the backplane, thus potentially paving the way for even cheaper fabrication, a more rapid integration and thereby a shorter time to market, and a slimmer form factor for both the LCD and the OLED version. The Company is now entering the completion phase of ECHO with the aim to finalize an integration license package that will facilitate easy commercialization.

Realfiction has set the following goals for the 13-16 months ECHO completion phase:           

  • Step one of the completion phase is to conduct a feasibility study to pre-validate the optimized backplane by January 2021. The feasibility study is co-funded by a recent Innobooster grant from Innovation Fund Denmark.           
  • Step two is to finish the remaining subprojects needed to complete the ECHO integration license package no later than end Q1 2022. This will happen in collaboration with a couple of leading European research institutes and facilities. The ECHO integration license package is expected to include specification of components, illustrations and diagrams needed for a multi-user ECHO display to be manufactured.            
  • Meanwhile during spring 2021, the goal is to seek a parallel co-development agreement with a commercial display manufacturer for the backplane. Although this component will also be developed in Step two with European research institutes, a cooperation with one of the large manufacturers would speed up the process of bringing ECHO to commercialization.           
  • Throughout the entire completion phase, focus will be on continuously strengthening and safeguarding the company’s ECHO IP portfolio.

The ECHO integration license package shall enable mass production of full-sized, multi-user ECHO display products at a price point affordable for a broad audience of consumers, as the anticipated demand will enable scaling of the production volume. A version of the first ECHO 3D display could potentially reach the market in 2023.

Realfiction has a strong financial position and expects to have the liquidity necessary to sustain all its business operations, including the development of ECHO, well into 2021 due to the combined positive impact of our cost savings initiatives and the granting of installment deferrals in 2021 on the loan with Vækstfonden, thus saving liquidity for the continued development of ECHO. The Company expects to complete its process of securing the additional funding required for the full ECHO completion phase before the end of 2020.

“We are excited about our latest finding of a potential optimization of the fabrication approach, which is expected to result in even lower manufacturing costs and a slimmer form factor for future ECHO 3D displays. We have started the feasibility study to pre-validate this finding with our new development partner Aalborg University, Denmark, and we expect that more partners will come onboard early in the completion phase,” says Steen Iversen, Realfiction’s Director of Advanced Display Technology.

“With the ECHO completion phase defined and underway, Realfiction continues to progress at a satisfactory pace despite being in the middle of a global pandemic. In addition to sharing Steen’s excitement for the future of ECHO, I want to highlight that specific licensing opportunities for part of or all of our ECHO IP portfolio and knowhow and/or collaboration agreements involving the completion of future full-size displays, may well arise during the completion phase, with the most promising discussions with display manufacturers and consumer electronics companies now planned for the spring of 2021. We are grateful to already have the support of the OEM LCD display manufacturer and large Realfiction shareholder AmTRAN when entering these discussions, as their industry knowledge and contacts could facilitate a more efficient exploration of our licensing and collaboration opportunities,” says Realfiction’s CEO Clas Dyrholm.

For more information about Realfiction Holding AB, please contact: 

Clas Dyrholm, founder and CEO 
Telephone: +45 25 22 32 81 
Email: [email protected]  
www.realfiction.com  

Certified Adviser  
Mangold Fondkommission AB is the company’s Certified Adviser and can be contacted via [email protected]  or +46 8 503 015 50.

This information is information that Realfiction Holding AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 8.15 CET on 19 November 2020. 

About Realfiction Holding AB

Founded in Denmark in 2008, Realfiction is a leading innovator and provider of Mixed Reality solutions and services, a market estimated to reach USD 80 billion by 2025. Realfiction continues to invent technologies within Mixed Reality, with an intention to disrupt the industry by pursuing the vision of converting science fiction into real fiction. Realfiction Holding AB’s share is publicly traded on Nasdaq Stockholm First North Growth Market under the symbol “REALFI”. The share’s ISIN code is SE0009920994.

About the agreement with Aalborg University

The development partner agreement with Aalborg University, Denmark provides Realfiction access to a Ph.d researcher specializing in thin film technology.

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/realfiction/r/realfiction-announces-its-plan-for-completion-of-the-echo-integration-license-package,c3239901

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SOURCE Realfiction

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Mycronic receives order for a SLX and a Prexision Lite 8 Evo mask writer

PR Newswire

STOCKHOLM, Nov. 19, 2020 /PRNewswire/ — Mycronic has received an order from a customer in Asia for an SLX and a Prexision Lite 8 Evo mask writer, which will replace one of the customer’s older systems. The order has a total value of between USD 12-14 million. Delivery of the SLX system is scheduled for the second quarter of 2021, while delivery of the Prexision Lite 8 Evo system is scheduled for the third quarter of the same year. 

The SLX laser mask writer was launched in October 2019 to meet rising demand for photomasks for the semiconductor industry, which is driven by long-term trends, and to meet the future need for replacement and modernization. The SLX mask writer is based on the new Evo control platform, which is shared by all of Mycronic’s new mask writers.

Prexision Lite 8 Evo, which was launched in 2019, is designed to meet demands for cost-effective photomask production of less advanced displays up to G8 mask size. The order for the Prexision Lite 8 Evo mask writer is to replace one of the customer’s older systems.

“It is gratifying that we are continuing to broaden cooperation with our existing customers. The combined order of a Prexision Lite 8 Evo, to replace an older system, and a SLX mask writer reaffirmed that our new products fulfill customer needs and that our product roadmap is in line with the needs of the display  and semiconductor industry,” says Charlott Samuelsson, Sr VP Pattern Generators at Mycronic. 

For additional information, please contact:

Charlott Samuelsson

Sr VP Pattern Generators
Tel: +46 709 844 282, e-mail: [email protected]

Tobias Bülow
Director Investor Relations
Tel: +46 734 018 216, e-mail: [email protected]

Cathrin Wisén
Director Corporate Communications
Tel: +46 721 663 469, e-mail: [email protected]

The information in this press release was published on November 19, 2020, at 08:00 a.m.
 

About Mycronic

Mycronic AB is a Swedish high-tech company engaged in the development, manufacture and marketing of production equipment with high precision and flexibility requirements for the electronics industry. Mycronic’s headquarters are located in Täby, north of Stockholm and the Group has subsidiaries in France, Japan, China, the Netherlands, Singapore, the United Kingdom, South Korea, Germany and the USA. Mycronic is listed on Nasdaq Stockholm. www.mycronic.com 

This information was brought to you by Cision http://news.cision.com

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SOURCE Mycronic AB

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GOGL – Third Quarter 2020 Results

Golden Ocean Group Limited (NASDAQ: GOGL / OSE: GOGL) (the “Company” or “Golden Ocean”), a leading dry bulk shipping company, today announced its results for the quarter ended September 30, 2020.

Highlights

▪           Net income of $39.1 million and earnings per share of $0.27 for the third quarter of 2020 compared with net loss of $41.3 million and loss per share of $0.29 for the second quarter of 2020.

▪           Adjusted EBITDA of $76.7 million for the third quarter of 2020, compared with $4.2 million for the second quarter of 2020.

▪           Signed loan agreement in November 2020 to refinance the $425.0 million credit facility which is secured by 14 Capesize vessels at attractive terms, lowering the daily cash break even rate for the financed vessels by more than $1,000 per financed ship.

▪           Strengthened balance sheet with cash and equivalents of $130.8 million and no debt maturities until 2023 following the aforementioned refinancing.

▪           Divested our 22.19% ownership interest in ship management company SeaTeam Management Pte Ltd and exited commercial management agreement for seven Handysize vessels to further focus on the Company’s core activities.

▪           Appointed Lars-Christian Svensen to the position of Chief Commercial Officer of Golden Ocean Management AS effective from December 1, 2020.

▪           Estimated TCE rates for the fourth quarter of 2020, inclusive of charter coverage and calculated on a load-to-discharge basis, are:

           · approximately $21,750 per day contracted for 73% of the available days for Capesize vessels;

           · approximately $12,750 per day contracted for 82% of the available days for Panamax vessels

We expect the spot TCEs for the full fourth quarter of 2020 to be lower than the TCEs currently contracted, due to the impact of ballast days at the end of the third quarter as well as current weaker rates.

Ulrik Andersen, Chief Executive Officer, commented:

“The Company’s results for the third quarter of 2020 demonstrate both its strong leverage to an improving rate environment as well as the strategic advantage gained by focusing exclusively on large vessel classes. Due to scale, fleet composition and strong chartering capabilities, the Company was well positioned to capture strength in both the charter and spot markets. The Company generated a significant amount of cash flow, bolstering its balance sheet in the third quarter of 2020. The Company also completed the expected refinancing of its largest debt facility that was due to mature in early 2021, pushing its nearest debt maturity to 2023. As the Company looks to 2021, it has very limited capital expenditure requirements and significant spot market exposure, which should allow for the continued generation of healthy cash flow.”

The Board of Directors
Hamilton, Bermuda
November 19, 2020

Questions should be directed to:

Ulrik Andersen: Chief Executive Officer, Golden Ocean Management AS
+47 22 01 73 53

Peder Simonsen: Chief Financial Officer, Golden Ocean Management AS
+47 22 01 73 45

The full report is available in the link below.


 

Forward Looking Statements

Matters discussed in this earnings report may constitute forward-looking statements. The Private Securities Litigation Reform Act of 1995 provides safe harbor protections for forward-looking statements, which include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements, which are other than statements of historical facts. The Company desires to take advantage of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and is including this cautionary statement in connection with this safe harbor legislation. Words such as “believe,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” “targets,” “projects,” “likely,” “will,” “would,” “could,” “seeks,” “potential,” “continue,” “contemplate,” “possible,” “might,” “forecasts,” “may,” “should” and similar expressions or phrases may identify forward-looking statements. The forward-looking statements in this report are based upon various assumptions. many of which are based, in turn, upon further assumptions, including without limitation, management’s examination of historical operating trends, data contained in the Company’s records and other data available from third parties. Although the Company believes that these assumptions were reasonable when made, because these assumptions are inherently subject to significant uncertainties and contingencies which are difficult or impossible to predict and are beyond the Company’s control, the Company cannot assure you that it will achieve or accomplish these expectations, beliefs or projections. The information set forth herein speaks only as of the date hereof, and the Company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this communication.

In addition to these important factors and matters discussed elsewhere herein, important factors that, in the Company’s view, could cause actual results to differ materially from those discussed in the forward-looking statements include, among other things, the strength of world economies, fluctuations in currencies and interest rates, general market conditions, including fluctuations in charter hire rates and vessel values, changes in demand in the dry bulk market, the length and severity of the COVID-19 outbreak, the impact of public health threats and outbreaks of other highly communicable diseases, changes in the Company’s operating expenses, including bunker prices, drydocking and insurance costs, the market for the Company’s vessels, availability of financing and refinancing, the impact of the expected discontinuance of LIBOR after 2021 on interest rates of the Company’s debt that reference LIBOR, changes in governmental rules and regulations or actions taken by regulatory authorities, potential liability from pending or future litigation, general domestic and international political conditions, potential disruption of shipping routes due to accidents, political events or acts by terrorists, and other important factors described from time to time in the reports filed by the Company with the U.S. Securities and Exchange Commission, including the Company’s most recently filed Annual Report on Form 20-F for the year ended December 31, 2019.

This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.


 

 

Attachment



Posted on

Lysogene Reports its Cash Position as of 30 September 2020

Lysogene Reports its Cash Position as of 30 September 2020

  • Cash and cash equivalents of €22.1 million1 as of 30 September 2020

PARIS–(BUSINESS WIRE)–
Regulatory News:

Lysogene (Paris:LYS) (FR0013233475 – LYS), a phase 3 gene therapy platform Company targeting central nervous system (CNS) diseases, today reports its cash position as of 30 September 2020.

As of 30 September 2020, cash and cash equivalents amounted to €22.1 million1 (compared to €23.8 million as of 30 June 2020) due notably to the payment of the Research Tax Credit (CIR) of €3.0 million for the 2019 fiscal year.

About Lysogene

Lysogene is a gene therapy Company focused on the treatment of orphan diseases of the central nervous system (CNS). The Company has built a unique capability to enable a safe and effective delivery of gene therapies to the CNS to treat lysosomal diseases and other genetic disorders of the CNS. A phase 2/3 clinical trial in MPS IIIA in partnership with Sarepta Therapeutics, Inc. is ongoing and a phase 1/3 clinical trial in GM1 gangliosidosis is in preparation. In accordance with the agreements signed between Lysogene and Sarepta Therapeutics, Inc., Sarepta Therapeutics, Inc. will hold exclusive commercial rights to LYS-SAF302 in the United States and markets outside Europe; and Lysogene will maintain commercial exclusivity of LYS-SAF302 in Europe. Lysogene is also collaborating with an academic partner to define the strategy of development for the treatment of Fragile X syndrome, a genetic disease related to autism. www.lysogene.com.

Forward Looking Statement

This press release may contain certain forward-looking statements, especially on the Company’s progress of its phase 2-3 clinical trial and cash runway. Although the Company believes its expectations are based on reasonable assumptions, all statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice, (ii) factors beyond the Company’s control, (iii) clinical trial results, (iv) increased manufacturing costs and (v) potential claims on its products. These statements may include, without limitation, any statements preceded by, followed by or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “objective”, “project,” “will,” “can have,” “likely,” “should,” “would,” “could” and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company’s control that could cause the Company’s actual results, performance or achievements to be materially different from the expected results, performance or achievements expressed or implied by such forward-looking statements. A further list and description of these risks, uncertainties and other risks can be found in the Company’s regulatory filings with the French Autorité des Marchés Financiers, including in the 2019 universal registration document, registered with the French Markets Authorities on April 30, 2020, under number D.20-0427, and future filings and reports by the Company. Furthermore, these forward-looking statements are only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by law, the Company assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. If the Company updates one or more forward-looking statements, no inference should be drawn that it will or will not make additional updates with respect to those or other forward-looking statements.

This press release has been prepared in both French and English. In the event of any differences between the two texts, the French language version shall supersede.

——————————————–

1 Unaudited

Stéphane Durant des Aulnois

Chief Financial Officer

[email protected]

+ 33 1 41 43 03 99

KEYWORDS: Europe United States North America France

INDUSTRY KEYWORDS: Health Infectious Diseases Stem Cells Genetics Other Health Clinical Trials Biotechnology

MEDIA:

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Furuno Offers KVH AgilePlans Maritime VSAT Connectivity in Japan

The AgilePlans program accelerates HTS VSAT adoption as a monthly subscription with no costly CAPEX and no long-term commitment for commercial fleets

MIDDLETOWN, R.I., Nov. 19, 2020 (GLOBE NEWSWIRE) — KVH Industries, Inc., (Nasdaq: KVHI), is pleased to announce that Furuno is offering AgilePlans® maritime VSAT connectivity in Japan. The KVH AgilePlans program is a Connectivity as a Service (CaaS) subscription-based model offering a comprehensive solution for maritime satellite communications. Without a costly capital outlay, the AgilePlans service eliminates barriers to upgrading to VSAT or switching from a competitor. It includes high-speed connectivity with unlimited email and texting via KVH’s mini-VSAT BroadbandSM HTS network, TracPhone® HTS-series hardware, with installation in as many as 4,000 ports and locations, cybersecurity protection, KVH OneCare™ maintenance, and no long-term commitment, all for one monthly fee.

“We are happy to offer KVH AgilePlans to commercial maritime fleets in Japan at this crucial time when the entire shipping industry is accelerating the pace of maritime digitalization,” says Keisuke Kitamura, general manager of the ICT engineering department for Furuno Electric Co., LTD.

“KVH is honored to collaborate with a highly regarded company such as Furuno to provide commercial fleets in the area with the all-inclusive, non-commitment AgilePlans offering, which has proven so successful for commercial fleets worldwide,” says Ken Loke, KVH vice president for Asia Pacific.

The AgilePlans service from Furuno is available with the TracPhone V7-HTS, a 60 cm Ku-band antenna featuring data speeds as fast as 10 Mbps down/3 Mbps up.

KVH is a mobile tech innovator that provides connectivity solutions for commercial maritime, leisure marine, and land mobile applications on vessels and vehicles, including the award-winning TracPhone and TracVision® product lines, the global mini-VSAT Broadband network, and AgilePlans Connectivity as a Service (CaaS). The company’s KVH Media Group provides news, sports, and entertainment content with such brands as NEWSlink™ and SPORTSlink™.

Note to Editors: For more information about AgilePlans, please visit the KVH website, kvh.com/agileplans. High-resolution images of KVH products are available at the KVH Press Room Image Library, kvh.com/Press-Room/Image-Library.

About Furuno

Since its inception in 1948, FURUNO has been responding to the needs of the maritime industry through development of a wide range of innovative marine products. Based upon the business vision of “Achieving better safety, security and comfort to bring about a society and sea navigation that considers the needs of people and the environment” and, “VALUE thru GLOBALIZATION and SPEED”, Furuno operates in two business segments. The Marine business segment develops, manufactures, and sells various types of navigation equipment, fishing equipment, and radio communication equipment. The Industrial business segment develops, manufactures and sells medical equipment and ICT devices, such as GPS and ITS (intelligent transportation systems) products, wireless LAN systems and infrastructure maintenance / management and meteorological monitoring and analysing system.

About KVH Industries, Inc.

KVH Industries, Inc., is a global leader in mobile connectivity and inertial navigation systems, innovating to enable a mobile world. A market leader in maritime VSAT, KVH designs, manufactures, and provides connectivity and content services globally. KVH is also a premier manufacturer of high-performance sensors and integrated inertial systems for defense and commercial applications. Founded in 1982, the company is based in Middletown, RI, with research, development, and manufacturing operations in Middletown, RI, and Tinley Park, IL, and more than a dozen offices around the globe.

This press release contains forward-looking statements that involve risks and uncertainties. For example, forward-looking statements include statements regarding the expected benefits to KVH customers of the AgilePlans service; the expected pricing of the new service; the expected level of coverage availability; and the ease of using the new service. Actual results could differ materially from the forward-looking statements made in this press release. Factors that might cause these differences include, but are not limited to: unanticipated technical and other challenges that arise with the services; capacity availability to support simultaneous terminals and/or users; unanticipated technical, legal, and regulatory delays with the services; customer and strategic partner responses; potential future changes to the pricing or other terms; and potential unforeseen costs or expenses of providing the products and services. These and other factors are discussed in more detail in KVH’s Form 10-Q filed with the SEC on October 29, 2020. Copies are available through its Investor Relations department and website, http://investors.kvh.com. KVH does not assume any obligation to update forward-looking statements to reflect new information and developments. 

KVH Industries, Inc., has used, registered, or applied to register its trademarks in the U.S.A. and other countries around the world, including but not limited to the following marks: KVH, AgilePlans, mini-VSAT Broadband, TracPhone, KVH OneCare, TracVision, NEWSlink, and SPORTSlink.

For
f
urther
information, please c
ontact:
Jill Connors
Sr. Manager, Media & Industry Analyst Relations
KVH Industries, Inc.
Tel: +1 401 851 3824
[email protected]



Posted on

Sequana Medical Announces Positive Interim Data From North American Pivotal alfapump® Study (POSEIDON)

  • Results from first 13 patients in Roll-In Cohort showed o
    ver 90% reduction in
    mean
    frequency of
    t
    herapeutic
    p
    aracentesis
    versus
    b
    aseline
  • Indication of r
    apid and persistent c
    linically relevant improvement in
    patients’
    q
    uality
    of
    l
    ife
  • Safety
    profile
    in line with expectations
  • Interim data of the full Roll-In Cohort expected in H1 2021


Conference call with



live webcast presentation



today at


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GHENT, Belgium, Nov. 19, 2020 (GLOBE NEWSWIRE) — Sequana Medical NV (Euronext Brussels: SEQUA), an innovator in the management of fluid overload in liver disease, malignant ascites and heart failure, today announces positive interim results from the first 13 patients in the Roll-In Cohort of the North American pivotal POSEIDON study of the alfapump for the treatment of recurrent or refractory ascites due to liver cirrhosis. These interim data show positive outcomes against all primary endpoints of the study1, as well as indications of clinically relevant improvements in quality of life measures.

Professor Florence Wong, University of Toronto, Hepatologist at Toronto General Hospital, Ontario, Canada and Principal Investigator for the POSEIDON study, commented: “I am delighted to see the first, positive, results of these roll-in patients. The dramatic reduction in the need for therapeutic paracentesis and improvement in quality of life is consistent with my long experience with the alfapump. The adverse events were as expected in this population of patients and easily controlled with the standard of care treatments. So if the results are replicated in all study patients, it would be an important improvement in the care for this poorly served patient population.”

POSEIDON is a single arm, open-label, within subject crossover study of the alfapump in patients with recurrent or refractory ascites due to liver cirrhosis in the U.S. and Canada. The study includes a “Pivotal Cohort” with up to 50 patients implanted with the alfapump for primary endpoint analysis and an additional “Roll-In Cohort” with up to 30 patients to ensure new centres are familiarised with the alfapump system before they enrol patients in the Pivotal Cohort.

The study is designed to demonstrate in Pivotal Cohort patients 1) a 50% reduction in average monthly frequency of therapeutic paracentesis (TP) post-alfapump implant versus pre-implant and that 2) at least 50% of patients will achieve a 50% reduction in the requirement for TP post-implant versus pre-implant. Paracentesis is the mainstay in chronic clinical management of refractory ascites but it is an invasive procedure, requiring frequent hospitalisations, severely impacting patients’ quality of life and provides only temporary benefit.

In this interim analysis, 13 patients from the Roll-In Cohort (underlying etiology: 61% alcohol, 23% non-alcoholic steatohepatitis (NASH), 8% hepatitis C and 8% mixed etiology) were implanted with the alfapump. Before enrolment, these patients required on average 3.4 TP per month. The mean reduction in the frequency of TP post-implant versus pre-implant was over 90%, with all patients having at least a 50% reduction in the average frequency of TP per month1.

Patient’s quality of life was assessed via established health-survey questionnaires. Results from SF36 (a general health quality survey) indicated clinically relevant improvements in the physical component score and improvement was seen in all SF36 subscales. Ascites Q, a questionnaire developed for patients with ascites also indicated clinically relevant improvement in patient’s quality of life and the improvement was seen in all subdomains of the survey. In both cases, the improvement was seen rapidly (within a month of implantation) and was persistent (6 months after implantation).

Based on these interim data, the safety profile of the alfapump is consistent with previously reported data. The adjudication process by the Clinical Events Committee (CEC) for two alfapump explants in respect of the primary safety outcome is still ongoing.

Ian Crosbie, Chief Executive Officer at Sequana Medical,
added
: “The substantial reduction in the need for therapeutic paracentesis, good safety profile and clinically relevant improvement in quality of life reported in this study so far is very encouraging. These data further validate the potential of alfapump as a much needed treatment option in this underserved patient population and is an important milestone towards achieving a future marketing application in the U.S. and Canada. The increasing prevalence of NASH-related cirrhosis in this market and the limitations of the current standard of care has been recognized in our FDA Breakthrough Device Designation for alfapump, which will allow us to bring this innovative technology to patients in need as quickly as possible.”

Interim data of the full Roll-In Cohort are expected in H1 2021 and primary endpoint read-out of the Pivotal Cohort is expected in Q1 2022. The POSEIDON study is intended to support a future marketing application of the alfapump in the U.S. and Canada, with an FDA submission expected in mid-2022.

1 Pre- and post-implant periods for this analysis of the Roll-In Cohort differ from those that will be used for the Pivotal Cohort analysis


Conference Call and Webcast

Sequana Medical will host a conference call with live webcast presentation today at 02:00 pm CET / 08:00 am EDT.

  • Registration webcast: please click here
  • Registration conference call (only if you wish to participate in the Q&A): please click here. Once registered, you will receive dial-in numbers and a confirmation code.

The webcast and conference call will be conducted in English and a replay will be available on Sequana Medical’s website shortly after.

For more information, please contact:

Sequana Medical

Lies Vanneste, Director Investor Relations
Tel: +32 498 05 35 79
Email: [email protected]

Consilium
Strategic Communications

Amber Fennell, Ashley Tapp, Melissa Gardiner
Tel: +44 203 709 5000
Email: [email protected]		 LifeSci
Advisors

Chris Maggos
Tel: +41 79 367 6254
Email: [email protected]

About the pivotal POSEIDON study

This is a single-arm, open-label, within subject crossover study of the alfapump in patients with recurrent or refractory ascites due to liver cirrhosis in approximately 20 centres across the U.S. and Canada. Up to 60 patients are being enrolled in the Pivotal Cohort, entering into the pre-implant observation period, allowing for up to 50 patients to be implanted with the alfapump for primary endpoint analysis. The study allows for up to 30 patients to be enrolled in a Roll-In Cohort, to ensure centres are experienced with the alfapump prior to enrolment of patients in the Pivotal Cohort.

Pivotal Cohort patients will enter into a three month pre-implant observation period in which they will receive standard of care therapy (consisting of therapeutic paracentesis) before the alfapump is implanted. Patients from the Roll-In cohort will upon implementation of the inclusion/exclusion criteria, immediately be implanted with the alfapump. The primary effectiveness outcomes of the study include the proportion of patients with a 50% reduction in the overall average frequency of therapeutic paracentesis per month in the post-implant observation period (month four to month six after implantation) as compared to the pre-implant observation period. The primary safety endpoint is the rate of alfapump related re-interventions adjudicated by the Clinical Events Committee. Patients will be followed for up to two years for analysis of secondary outcome measurements including safety (device and/or procedure-related adverse events), quality of life (assessed by general SF36 as well as disease-specific Ascites Q questionnaires), patients’ nutritional status, health economics and overall survival. For more information about the study, please visit clinicaltrials.gov (NCT03973866).

About recurrent and refractory ascites

Ascites is a condition where excess fluid builds up in your abdomen. Ascitic fluid is a protein-containing fluid that leaks from the liver as a result of advanced liver cirrhosis. Patients may accumulate as much as 10 to 15 litres of ascitic fluid within the abdomen every 15 days. Patients suffering from recurrent or refractory ascites have limited treatment options and often have severely impacted quality of life due to the severe swelling of the abdomen, resulting in pain, difficulty breathing, moving, sleeping and eating, the development of various hernias and the risk for developing renal dysfunction. The number of patients with refractory liver ascites is expected to increase dramatically due to the growing prevalence of NASH (Non-alcoholic Steatohepatitis)–related cirrhosis.

Sequana Medical’s alfapump is a fully-implanted, programmable, wireless, CE-marked device that automatically pumps ascites from the peritoneal cavity into the bladder, where the body eliminates the ascites naturally through urination. The potential of the alfapump to address the unmet medical need in patients with recurrent or refractory ascites has been demonstrated in multiple clinical studies showing a significant reduction in the need for large volume paracentesis and a significant improvement in patients’ quality of life.

About Sequana Medical

Sequana Medical is a commercial stage medical device company developing the alfapump platform for the management of fluid overload in liver disease, malignant ascites and heart failure where diuretics are no longer effective. Fluid overload is a fast growing complication of advanced liver disease driven by NASH (non-alcoholic steatohepatitis) related cirrhosis and a common complication in heart failure. The U.S. market for the alfapump resulting from NASH-related cirrhosis is forecast to exceed €3 billion annually within the next 10-20 years. The heart failure market for the alfapump DSR (Direct Sodium Removal) is estimated to be over €5 billion annually in the U.S. and EU5 by 2026. Both indications leverage Sequana Medical’s alfapump, a unique, fully implanted wireless device that automatically pumps fluid from the abdomen into the bladder, where it is naturally eliminated through urination.

In the U.S., the company’s key growth market, the alfapump has been granted breakthrough device designation by the FDA. The North American pivotal study (POSEIDON) in recurrent or refractory ascites due to liver cirrhosis is currently underway, and is intended to support a future marketing application of the alfapump in the U.S. and Canada. In Europe, the alfapump is CE-marked for the management of refractory ascites due to liver cirrhosis and malignant ascites and is included in key clinical practice guidelines. Over 800 alfapump systems have been implanted to date. Building on its proven alfapump platform, Sequana Medical is developing the alfapump DSR, a breakthrough, proprietary approach to fluid overload due to heart failure. Clinical proof-of-concept was achieved in a first-in-human single dose DSR study and further supported by strong interim safety and efficacy results from the ongoing repeated dose alfapump DSR study (RED DESERT) in heart failure patients.

Sequana Medical is headquartered in Ghent, Belgium. For further information, please visit www.sequanamedical.com.


Important Regulatory Disclaimers


The 

alfa

pump
® system is not currently approved in the United States or Canada. In the United States and Canada, the 

alfa

pump
® system is currently under clinical investigation (POSEIDON Study) and is being studied in adult patients with refractory or recurrent ascites due to cirrhosis. For more information regarding the POSEIDON clinical study see 

www.poseidonstudy.com

.
The DSR therapy is still in development and it should be noted that any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed.
The DSR therapy is not currently approved for clinical research in the United States or Canada. There is no link between the DSR therapy and ongoing investigations with the 

alfa

pump
® system in Europe
, the United States or Canada
.


Forward-looking statements


This press release may contain predictions, estimates or other information that might be considered forward-looking statements. Such forward-looking statements are not guarantees of future performance. These forward-looking statements represent the current judgment of Sequana Medical on what the future holds, and are subject to risks and uncertainties that could cause actual results to differ materially. Sequana Medical expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release, except if specifically required to do so by law or regulation. You should not place undue reliance on forward-looking statements, which reflect the opinions of Sequana Medical only as of the date of this press release.



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With Elekta Studio, Elekta brings complete image-guided brachytherapy workflow to a single room

Introduction of ImagingRing completes Elekta Studio, unleashing full potential of interventional radiotherapy

PR Newswire

VEENENDAAL, The Netherlands, Nov. 19, 2020 /PRNewswire/ — Elekta (EKTA-B.ST) today introduced Elekta Studio with its launch of the ImagingRing, an advanced interventional CT system that revolves around the patient and enables clinicians to conduct the entire brachytherapy workflow – including applicator / needle insertion, imaging, planning and treatment delivery – without moving the patient from room to room. Elekta Studio was designed to radically simplify the 3D image-guided adaptive brachytherapy workflow and increase patient comfort.

“As the centerpiece of Elekta Studio, the ImagingRing provides clinicians with the images they need at every step of the brachytherapy workflow,” says John Lapré, President, Elekta Brachytherapy Solutions. “These include high-quality images for treatment planning as well as low-dose images for guidance and quality assurance. The system was designed for interventional use and allows access to the patient at all times.”

The ImagingRing is mobile, so it can be transported throughout the hospital to any desired location. A conventional CT, whether stationary or mobile, cannot offer real-time imaging nor the access to the patient as the ImagingRing does with its sleek design.

With the ImagingRing, no time has to be spent moving the patient from the treatment table to the CT and back, so applicator displacement is avoided, increasing treatment accuracy and patient comfort. In addition, since the ImagingRing is at the heart of the Elekta Studio, system transport and waiting times for an imaging slot – such as for a traditional CT scan – are eliminated, thus accelerating the workflow.

Professor Vratislav Strnad, MD, is Head of Interventional Radiation Oncology at University Hospital Erlangen, one of Germany’s largest hospitals. The 1,400-bed facility receives approximately 500 patients annually for brachytherapy treatment.

Dr. Strnad says: “It will be very valuable to have a complete and optimal solution for image-guided brachytherapy immediately in the intervention room, ready to operate at any time. It’s a perfect result if high-quality imaging for brachytherapy can come to the patient and radiation oncologist, instead of the other way around. This results in more safety and more precision due to very low risk of applicator, catheter or needle displacement, greater patient comfort and less stress for the whole treatment team. Moreover, the entire treatment workflow will be accelerated by having all necessary equipment in a single room – making therapeutically potent, targeted brachytherapy an even more practical treatment option.”

John Lapré adds: “The most striking advantage of the ImagingRing is the spacious 121 cm bore diameter. The wide bore enables patient imaging in the lithotomy (“knees up”) position for the majority of brachytherapy cases – gynecological and prostate cancer patients.”

The ImagingRing product line was developed by medPhoton GmbH (Salzburg, Austria). Elekta has exclusive distribution rights for the mobile ImagingRing in brachytherapy. “On behalf of all at medPhoton, I’m very happy with the collaboration with Elekta,” says Heinz Deutschmann, CEO of medPhoton. “Many of us have a background in radiation oncology, where we’ve developed technology for adaptive image-guided solutions for years. It’s good to see that we’re closing the loop now, with the mobile ImagingRing coming to robotically assisted, image-guided brachytherapy.”

For more information, visit elekta.com/elektastudio

*Elekta Studio is comprised of multiple medical devices, some of which may not yet be available in all markets. Confirm availability with your local Elekta representative.

For further information, please contact:

Mattias Thorsson, Vice President, Corporate Communications
Tel: +46 70 865 8012, e-mail: [email protected]  

Time zone: CET: Central European Time

Raven Canzeri, Director, Media Relations
Tel: +1 770 670 2524, e-mail: [email protected]

Time zone: ET: Eastern Time

About Elekta

For almost five decades, Elekta has been a leader in precision radiation medicine. Our more than 4,000 employees worldwide are committed to ensuring everyone in the world with cancer has access to – and benefits from – more precise, personalized radiotherapy treatments. Headquartered in Stockholm, Sweden, Elekta is listed on NASDAQ Stockholm Exchange. Visit elekta.com or follow @Elekta on Twitter.

This information was brought to you by Cision http://news.cision.com

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SOURCE Elekta

Posted on

Equinor ASA: Announcement of dividend per share in NOK for the second quarter 2020

Equinor (OSE: EQNR, NYSE: EQNR) announced on 24 July 2020 dividend per share of USD 0.09 for second quarter 2020.

The NOK dividend per share is based on average USDNOK fixing rate from Norges Bank in the period plus/minus three business days from record date 13 November 2020, in total seven business days.

Average Norges Bank fixing rate for this period was 9.0779. Second quarter 2020 dividend per share is consequently NOK 0.8170.

On 25 November 2020, dividend will be paid to shareholders on Oslo Børs (Oslo Stock Exchange) and to holders of American Depositary Receipts (“ADRs”) on New York Stock Exchange.

This information is subject to the disclosure requirements pursuant to Section 5-12 the Norwegian Securities Trading Act



Posted on

Nordic Nanovector ASA: Results for the Third Quarter 2020

PR Newswire

OSLO, Norway, Nov. 19, 2020 /PRNewswire/ — Nordic Nanovector ASA (OSE: NANO) announces its results for the third quarter 2020. A live webcast presentation by Nordic Nanovector’s management team will take place today in Oslo at 08.30 CET, see details below. A link to the webcast and the presentation is available from the company’s homepage (www.nordicnanovector.com).

Lars Nieba, Interim CEO of Nordic Nanovector, said:
“Following the successful interim analysis in August and completion of our private placement in September, we are progressing towards the major value inflection point of three-month top-line data from the PARADIGME clinical study, which is targeted for H2 2021. Generating these data will require us to successfully navigate the latest challenges of increased COVID-19 restrictions. We remain confident in our ability to achieve this goal, aided by the protocol amendments, the possibility to reduce the patient sample, and all the other measures we are actively implementing to drive patient recruitment into PARADIGME.”

Q3’2020 Highlights

  • Result of PARADIGME Interim Analysis: Independent Review Committee recommendation to focus on single arm investigating the “40/15” dosing regimen
    • Target set to report three-month top-line data in H2’2021
  • Approval of amendments to PARADIGME protocol is proceeding as planned and completed in the best-recruiting countries
    • Designed to enlarge the eligible patient population and increase the rate of enrolment into the trial
  • Pivotal Phase 2b PARADIGME trial of Betalutin® progressing in 3rd-line relapsed/refractory follicular lymphoma (3L R/R FL)
    • COVID-19 pandemic continues to have a negative impact on PARADIGME patient recruitment – the target patient population is a high-risk group for COVID-19
    • 59 patients enrolled as of 18 November 2020
  • Private placement was oversubscribed and successfully completed raising approximately NOK 231 million (approximately USD 25 million) in gross proceeds, extending cash runway into Q3’2021
    • Funds to be used to advance PARADIGME study and conduct other essential activities to enable a timely filing pending top-line data
  • Dr Christine Wilkinson Blanc appointed Chief Medical Officer

Events after Q3’2020

  •  Final two patients enrolled into Archer-1 Phase 1 safety trial of Betalutin® plus rituximab in 2L R/R FL
    • Preliminary data readout expected in H1’2021
    • Trial to be paused pending analysis of data and evaluation of plans for further development
  • Results of preclinical studies demonstrating Betalutin® reverses tumour resistance to rituximab in NHL disease models published in Journal of Nuclear Medicine

Financial Highlights

(Figures in brackets = same period 2019 unless otherwise stated)

  • Revenues for the third quarter and for the first nine months of 2020 amounted to NOK 0.0 million (NOK 0.0 million)
  • Total operating expenses for the third quarter were NOK 88.1 million (NOK 100.2 million); total operating expenses for the first nine months of 2020 were NOK 327.3 million (NOK 301.1 million)
  • Comprehensive loss for the third quarter amounted to NOK 88.2 million (loss of NOK 93.6 million); comprehensive loss for the first nine months of 2020 was NOK 305.4 (NOK 295.6 million)
  • Cash and cash equivalents amounted to NOK 380.7 million at the end of September 2020, compared to NOK 470.8 million at the end of December 2019

Outlook

The company continues to target the readout of three-month top line data from PARADIGME in H2’2021. Approval of protocol amendments is proceeding as planned and completed in the best-recruiting countries, and other initiatives to increase the rate of enrolment are underway. The company also targets the readout of three-month top line data from the second cohort of the Archer-1 trial in H1’2021.

However, the impact of the COVID-19 pandemic on patient recruitment has worsened in light of the emergence of a second wave resulting in severe travel restrictions being implemented in the various countries where we are executing our clinical studies. These restrictions and uncertainty around the duration, severity and geographic scope of the COVID-19 outbreak are projected to slow down the enrolment of patients due to re-prioritisation of hospital activities towards COVID-19 patients and away from clinical studies such as PARADIGME.  In addition, travel restrictions could create logistical challenges for the shipment of clinical supplies. Several proactive actions have been taken to minimize the impact of these travel restrictions which could blunt further delays in completing enrolment and delivering preliminary results as targeted.

The company has taken steps to conserve cash and following the recent successful private placement, Nordic Nanovector has a cash runway that extends into Q3’2021.

Despite the challenging times, the many positive actions the company has made in the last nine months have improved the prospects of delivering pivotal results from PARADIGME in H2’2021.

The company continues to believe that, if positive, these trial data could represent a significant value inflection point for the company and its shareholders, confirming Betalutin® as a highly promising new targeted therapy that can address the unmet needs of R/R FL patients.

Presentation and live webcast – Q3 2020 results

A presentation and live webcast by Nordic Nanovector’s management team will take place today at 8:30 am CET.

The webcast can be accessed from www.nordicnanovector.com in the section: Investors & Media and a recording will also be available on this page after the event.

The results report and the presentation is available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2020.

For further information, please contact:

IR enquiries

Malene Brondberg, CFO

Cell: +44 7561 431 762

Email: [email protected]  

Media Enquiries

Mark Swallow/Frazer Hall/David Dible (Citigate Dewe Rogerson)

Tel: +44 203 926 8535

Email: [email protected]  

About Nordic Nanovector:

Nordic Nanovector is committed to develop and deliver innovative therapies to patients to address major unmet medical needs and advance cancer care. The Company aspires to become a leader in the development of targeted therapies for haematological cancers. Nordic Nanovector’s lead clinical-stage candidate is Betalutin®, a novel CD37-targeting antibody-radionuclide-conjugate designed to advance the treatment of non-Hodgkin’s lymphoma (NHL). NHL is an indication with substantial unmet medical need, representing a growing market forecast to be worth nearly USD 29 billion by 2026. Nordic Nanovector retains global marketing rights to Betalutin® and intends to actively participate in the commercialisation of Betalutin® in the US and other major markets.

Further information can be found at www.nordicnanovector.com .

Forward-looking statements

This press release contains certain forward-looking statements. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on Nordic Nanovector’s business, financial condition and results of operations. The terms “anticipates”, “assumes”, “believes”, “can”, “could”, “estimates”, “expects”, “forecasts”, “intends”, “may”, “might”, “plans”, “should”, “projects”, “targets”, “will”, “would” or, in each case, their negative, or other variations or comparable terminology are used to identify forward-looking statements. These forward-looking statements are not historic facts. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied in the forward-looking statements. Factors that could cause these differences include, but are not limited to, risks associated with implementation of Nordic Nanovector’s strategy, risks and uncertainties associated with the development and/or approval of Nordic Nanovector’s product candidates, ongoing and future clinical trials and expected trial results, the ability to commercialise Betalutin®, technology changes and new products in Nordic Nanovector’s potential market and industry, Nordic Nanovector’s freedom to operate (competitors patents) in respect of the products it develops, the ability to develop new products and enhance existing products, the impact of competition, changes in general economy and industry conditions, and legislative, regulatory and political factors. No assurance can be given that such expectations will prove to have been correct. Nordic Nanovector disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

This information is subject to a duty of disclosure pursuant to Sections 4-2 and 5-12 of the Securities Trading Act.

This information was brought to you by Cision http://news.cision.com

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SOURCE Nordic Nanovector