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Cytovance Biologics offers Nature Technology Corporation’s proprietary HyperGRO™ manufacturing platform for plasmid DNA CGMP manufacturing

OKLAHOMA CITY, Nov. 30, 2020 (GLOBE NEWSWIRE) — Cytovance® Biologics, a leading biopharmaceutical contract development and manufacturing organization (CDMO) of mammalian, microbial biologics and gene therapy plasmid DNA (pDNA), announces a new agreement with Nature Technology Corporation (NTC) for use of NTC’s proprietary HyperGRO™ manufacturing platform. This announcement is on the heels of Cytovance launching its Keystone Expression System® pDNA manufacturing licensing program.

“Our pDNA programs have greatly advanced due, in-part, to our use of NTC’s HyperGRO™ technology,” stated Bin Zhang, CEO of Cytovance Biologics. “We look forward to extending our collaborative work to benefit more clients with their gene therapy projects.”

Cytovance’s Keystone Expression System pDNA manufacturing platform is uniquely designed to process plasmids with low shear lysis and purification steps to produce high quality, high yield pDNA. Cytovance is highly experienced in pDNA manufacturing and offers three quality levels including R&D Grade, Cytograde™ and CGMP Grade depending on the needs of the client.

“NTC has worked with Cytovance through many successful projects,” stated Deborah Moorad-Watts, CEO of Nature Tech. “We are excited to support them and their clients with our HyperGRO™ platform and bring more qualified drug options to market.”

About Cytovance® Biologics

Cytovance® Biologics is a leading biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that excels in the rapid and cost-effective development and manufacture of large molecule active pharmaceutical ingredients (APIs) from both mammalian cell culture and microbial fermentation such as monoclonal antibodies, fragment antibodies, bispecifics, enzymes, fusion proteins, vaccines and other biological products including plasmid DNA and cell-based therapeutics. In addition to its clinical and commercial CGMP API manufacturing services, Cytovance offers well-integrated development services supporting the entire product lifecycle including cell line development, cell banking, microbial strain development, process and analytical development, and process characterization. A centralized, responsive program management team coordinates all critical chemistry manufacturing and controls (CMC) activities for each client program around raw materials management, QC testing, ICH stability studies, and regulatory support.  Our 140,000 sq. ft. state-of-the-art facilities in Oklahoma City are designed to meet U.S., EU, and other global regulatory standards.

Cytovance offers deep industry expertise and unique customized services for the scale-up and CGMP manufacture of protein-based therapeutics; from early-stage pre-clinical development to commercial production, for both mammalian and microbial. Further information can be found at www.cytovance.com.

About Nature Technology Corporation

Nature Technology Corporation is a developer of proprietary vector and manufacturing platforms which offer wide applications to improve the safety and performance of non-viral and viral vector derived gene therapy and cell therapy biologics, including antibiotic-free selection (RNA-OUT), the HyperGRO™ Fermentation Process, and best in class Nanoplasmids™. NTC also provides cost effective outsourcing of product development services including custom gene design, non-viral and viral vector retrofitting, vector construction, and plasmid DNA manufacturing. For more information about NTC products and business related inquiries, visit www.natx.com.

Media Contact:

Jodie Gutkowski
Tel: 405-319-8309        
E-mail: [email protected] 



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Northern Data AG Opens First Own Data Center in Frankfurt

Northern Data AG Opens First Own Data Center in Frankfurt

Northern Data AG opens first own data center in Frankfurt

  • GPU cluster will serve as HPC platform for research and industry
  • Cooperation with University Frankfurt and GSI Helmholtzzentrum Darmstadt
  • Mobile high-tech data centers form the basis of the infrastructure

FRANKFURT AM MAIN, Germany–(BUSINESS WIRE)–
Northern Data AG (XETRA: NB2, ISIN: DE000A0SMU87) starts operating its first data center at its Frankfurt am Main location. From December 2020, the Frankfurt location will make up part of the Company’s Distributed Computing Cluster, based on its mobile high-tech data centers. This will add to the Company’s worldwide network of GPU clusters, including in the Netherlands, Scandinavia and Canada. Feasibility studies (Proof of Concept) are planned at the Frankfurt site in cooperation with research and industry.

Stefan Sickenberger, COO of Northern Data, explains: “High-Performance Computing has become an integral part of research and large parts of industry. Parallel processor systems and clusters are needed to process large volumes of data at high speed and with maximum stability. A key driver of success is lower energy consumption and high power efficiency. We are pleased to be working closely with our research partners on this project. We are particularly proud of our cooperation with the High-Performance Computing Architecture group at the Goethe University Frankfurt, which commands a great deal of expertise, especially in the area of Green IT”.

Volker Lindenstruth, Professor of High-Performance Computing Architecture at Frankfurt Goethe University and member of the Board of Directors of the Frankfurt Institute for Advanced Studies (FIAS) comments: “We are delighted to be working with Northern Data. This project involves coupling the research supercomputers of Goethe University and the GSI Helmholtz Centre for Heavy Ion Research with Northern Data’s own supercomputers, making the best use possible out of our combined capabilities and existing hardware. Peak loads can be intercepted, while particularly large jobs can be started with minimal delay. Example scientific applications include calculations and modelling in particle physics and relativistic astrophysics, environmental and atmospheric physics, as well as applications in life sciences, for example, precise and automated detection of cancer cells in tissue sections.

Aroosh Thillainathan, CEO of Northern Data, adds: “Above all, our concept of ‘design-to-cost’ is particularly important to this project. We not only manage the customer’s data center and hardware but also the software, enabling us to optimize the data center operations to meet the customer’s actual needs. In contrast to pure colocation providers, which have no influence on, for example, the load distribution of their customers and their software processing within the data center, we are able to regulate this with our management software. Among other things, we also control the cooling capacity very efficiently in terms of the required computing power, and this enables us to achieve excellent PUE values. Our customers save energy and achieve cost savings as a result. Together with our targeted selection of locations in northern regions, this allows us to offer our customers high-quality HPC solutions tailored to their needs, while remaining extremely cost-efficient at the same time.

About Northern Data:

Northern Data AG develops and operates global infrastructure solutions in the field of High-Performance Computing (HPC). With its customer-specific solutions, the company provides the infrastructure for various HPC applications in areas such as bitcoin mining, artificial intelligence, blockchain, big data analytics, IoT or rendering. The internationally active company is today a leading provider of HPC solutions worldwide. Northern Data offers its HPC solutions both in large, stationary data centers and in mobile high-tech data centers that can be set up at any location worldwide. The company combines self-developed software and hardware with intelligent concepts for a sustainable energy supply. The Northern Data group currently employs about 150 members of staff.

Disclaimer:

This press release does not constitute an offer to sell or a solicitation of an offer to purchase or subscribe for any securities of Northern Data AG, nor does it constitute a securities prospectus of Northern Data AG. The information contained in this press release is not intended to serve as a basis for financial, legal, tax or other business decisions. Investment or other decisions should not be based solely on this press release. As with all business and investment matters, please consult qualified professional advice.

Language:

English

Company:

Northern Data AG

Thurn-und-Taxis-Platz

6 60313 Frankfurt/Main

Germany

Phone:

+49 69 34 87 52 25

E-mail:

[email protected]

Internet:

www.northerndata.de

ISIN:

DE000A0SMU87

WKN:

A0SMU8

Listed:

Regulated Unofficial Market in Berlin, Dusseldorf, Frankfurt, Munich (m:access), Tradegate Exchange

 

Northern Data AG

Dr. Hans Joachim Dürr

Head of Corporate Communications

e-mail: [email protected]

Phone: +49 69 348 752 89

Investor Relations:

Sven Pauly

e-mail: [email protected]

Phone: +49 89 125 09 03 30

KEYWORDS: Germany Europe

INDUSTRY KEYWORDS: Professional Services Data Management Security Technology Finance Networks Hardware

MEDIA:

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Borr Drilling Limited Announces Preliminary Results for the Third Quarter of 2020

PR Newswire

HAMILTON, Bermuda, Nov. 30, 2020 /PRNewswire/ — Borr Drilling Limited (“Borr”, “Borr Drilling” or the “Company”) announces unaudited results for the three and nine months ended September 30, 2020.

Highlights in the Third Quarter of 2020

  • Total operating revenues of $59.2 million, net loss of $61.9 million and Adjusted EBITDA of $(10.1) million for the third quarter of 2020.
  • The combined Adjusted EBITDA of the four separate Mexican JVs that the Company has ownership in was $45.2 million in the third quarter of 2020, compared to Adjusted EBITDA in the second quarter of 2020 of $30.1 million, an increase of $15.1 million, or 50%, quarter on quarter.
  • In August 2020, Patrick Schorn was announced as the Company’s new Chief Executive Officer with effect from September 8, 2020, taking over for Svend Anton Maier
  • In September, the Company announced additional amendments to its loan agreements with its syndicate banks and Hayfin, that include extensions of debt maturities of $595 million until January 2023.
  • On September 30, 2020, the Company announced the pricing and allocation of an equity offering for 51,886,793 shares, each at a subscription price of $0.53 per share, raising gross proceeds of $27.5 million. The offering was settled October 5, 2020.

Subsequent events

  • On October 10, 2020, the Company announced the appointment of Christoph Bausch as its new Chief Financial Officer, replacing Francis Millet with effect from November 1, 2020.
  • The Company entered into agreements to sell its remaining cold stacked jack-up drilling rigs “Atla” and “Balder” to BW Energy for total sale proceeds of $14.5 million. $13 million was received at the time of issuing this report.
  • The previously announced sale of the standard jack-up drilling rig “Eir” was completed in October for total cash proceeds of $3 million.
  • In November 2020, the Company collected proceeds of $8.8 million from its Paragon litigation trust receivable.
  • On November 25, 2020 the Company announced the completion and allocation of a rights offering related to the equity offering in September, in which 10 million shares were sold to holders of Borr Drilling shares at $0.53 per share, raising gross proceeds of $5.3 million.

CEO, Patrick Schorn commented:


“In the third quarter we operated the lowest number of active rigs since the start of the COVID pandemic, which was the result of contract cancellations and suspensions caused by operators pushing out their anticipated work scope. This resulted in a sequential decrease in operating revenues of 30% to $59.2 million, and Adjusted EBITDA of $(10.1) million. Additionally, our third quarter results were negatively impacted by incremental costs directly related to Covid-19, amounting to $7.6 million and severance costs as a result of adjusting our headcount to the new market environment of $2.2 million. From this low point of seven active rigs, we rebounded and at the date of this report, we have 11 active rigs after successful contract start-ups in the North Sea and in Malaysia. Tendering activity and price negotiations remained at an elevated level during the COVID pandemic, however day rates are under pressure as a function of the lower industry utilization. The total number of contracted jack-up rigs at the end of the third quarter 2020 was 346, down by four quarter on quarter. Out of these, 242 were modern units and 104 standard units, showing that modern units are continuing to gain market share.

Managing liquidity continues to be a priority and apart from optimizing working capital, Borr Drilling was able, as the only company in the drilling contractor space, to raise equity twice this year, with the share price trading above the issue price in both transactions, confirming the support from our shareholders and the potential of Borr Drilling’s modern jack-up fleet.

The Mexico operating unit was the largest contributor to our quarterly results with five active rigs working for Pemex. We continue to be  pleased with the operational performance and the incremental production we delivered to PEMEX, as the wells drilled by our JV in Mexico made up a significant portion of the annual production increase reported by Pemex. As highlighted previously, during the quarter we have had several interactions with Pemex regarding collections and the need for more timely payments. Our meeting in August with the full top management of Pemex resulted in strong assurances and commitments about future payments. The situation improved substantially, but we have recently experienced a slowdown in payments from Pemex causing operational challenges. 

Our focus for the next months will be to continually increase our active rig fleet as we have done during the third quarter. Our unique assets combined with a first-class workforce will continue to provide differentiation in the market. The integrated service projects in Mexico have confirmed that Borr is fully capable of adding value and that significant improvement in drilling efficiency can be achieved for the operator by converting traditional contract drilling to integrated services. 

As reported earlier, significant efforts have been made during the quarter to strengthen the financial position of the Company and extend the liquidity runway. Specific discussions are taking place with each of the creditor groups. The desired outcome, once completed, will include contributions from all creditors, by either a reduction or deferral of cash interest and other related costs, an extension of maturities and a more flexible security package. Part of these negotiations is to restructure our corporate structure, allowing a better ringfencing of entities with corresponding liens or different creditor groups. This would enable the lower leveraged components of the envisioned corporate structure to attract additional capital, thereby strengthen the group’s overall liquidity and financial position. We are making good progress and we are hopeful to have this combined package of measures in place in the near future.”

The full report, financial statements and Fleet Status Report is available in the enclosed file to this release.

November 30, 2020

The Board of Directors
Borr Drilling Limited 
Hamilton, Bermuda

Questions should be directed to: 
Magnus Vaaler: VP Investor Relations and Treasury, +47 22483000 

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

https://news.cision.com/borr-drilling-limited/r/borr-drilling-limited-announces-preliminary-results-for-the-third-quarter-of-2020,c3245798

The following files are available for download:


https://mb.cision.com/Public/16983/3245798/b99897ef444fc41b.pdf

3rd Quarter 2020 Results


https://mb.cision.com/Public/16983/3245798/a78c5ec09a1e5826.pdf

Fleet Status Report November 2020

 

Cision View original content:http://www.prnewswire.com/news-releases/borr-drilling-limited-announces-preliminary-results-for-the-third-quarter-of-2020-301181443.html

SOURCE Borr Drilling Limited

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Nordic Nanovector announces change of its Oslo Børs ticker symbol to ‘NANOV’

PR Newswire

OSLO, Norway, Nov. 30, 2020 /PRNewswire/ — Nordic Nanovector ASA (OSE: NANOV) announces that the Company’s ticker symbol on the Oslo Børs will change from ‘NANO’ to ‘NANOV’ and will be effective as of the start of trading on 30 November 2020.

The change of ticker follows Oslo Børs’ integration into Euronext’s trading platform Optiq. Over 60 companies whose shares trade on OSE have the same ticker symbol as companies on other Euronext-markets and have been required to change their tickers. 

The announcement by the Oslo Børs can be found here:

www.oslobors.no/Oslo-Boers/Notering/Nytt-handelssystem-30.-november

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 radioimmunotherapy 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.

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

https://news.cision.com/nordic-nanovector/r/nordic-nanovector-announces-change-of-its-oslo-bors-ticker-symbol-to–nanov-,c3245780

 

Cision View original content:http://www.prnewswire.com/news-releases/nordic-nanovector-announces-change-of-its-oslo-bors-ticker-symbol-to-nanov-301181442.html

SOURCE Nordic Nanovector

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LeoVegas first to offer open banking

PR Newswire

STOCKHOLM, Nov. 30, 2020 /PRNewswire/ — LeoVegas will be first out in the gaming industry to allow open banking transactions under PSD2 via the company’s proprietary technical platform. This will result in even more secure and faster payments for customers directly from their own bank accounts as well as lower transaction costs and a reduced dependence on other payment service providers for LeoVegas.

“Secure, seamless and fast payments are incredibly important, and the fact that we now – through PSD2 (the Second European Payment Services Directive) – have the opportunity to directly integrate with many European banks, will provide a superior customer experience offered by security and speed,” comments Gustaf Hagman, LeoVegas’ Group CEO. “Conducting transactions via open banking is also considerably more cost-effective compared with traditional payment methods. There is a high level of activity in our product and technology development organisation, and it is exciting to see all of the innovations we are delivering to our customers. We are first out in the industry with this pioneering payment solution, which will change the entire payments industry in the years ahead.”

The UK is the first market in which LeoVegas has already launched payments via open banking. Customer data from the initial weeks show that 10% of all new customers already are choosing to initiate their payments via open banking. The solution will be successively rolled out across several of the company’s core markets in Europe.

OPEN BANKING AND PSD2

PSD2 stands for the EU’s Second Payment Services Directive, which aims to develop the market for electronic payments and thereby create better conditions for secure and effective payments. Open banking is one aspect of PSD2 and entails that actors open up and share information with each other. The opportunities afforded by open banking include coupling together business models that together form a new ecosystem for payments, creating added value for customers.

For further information, please contact:


Gustaf Hagman, Group CEO 
+46 (0) 8 410 367 66, [email protected]

Philip Doftvik, Director of Investor Relations and Corporate Finance
+46 73 512 07 20, [email protected]

ABOUT LEOVEGAS MOBILE GAMING GROUP:

LeoVegas vision and position is “King of Casino”. The global group LeoVegas Mobile Gaming Group offers games on Casino, Live Casino, Bingo and Sport. The parent company LeoVegas AB (publ.) is located in Sweden and its operations are mainly located in Malta. The company’s shares are listed on Nasdaq Stockholm. www.leovegasgroup.com

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

https://news.cision.com/leovegas-mobile-gaming-group/r/leovegas-first-to-offer-open-banking,c3245779

The following files are available for download:


https://mb.cision.com/Main/17434/3245779/1341510.pdf

LeoVegas first to offer open banking

 

Cision View original content:http://www.prnewswire.com/news-releases/leovegas-first-to-offer-open-banking-301181439.html

SOURCE LeoVegas Mobile Gaming Group

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Number of shares and votes in Oncopeptides

PR Newswire

STOCKHOLM, Nov. 30, 2020 /PRNewswire/ — Oncopeptides AB (Nasdaq Stockholm, ONCO), a pharmaceutical company focused on the development of targeted therapies for difficult-to-treat hematological diseases,  today announces that the number of shares and votes in Oncopeptides has changed due to the exercise of warrants under the company’s incentive program.

Through the exercise of warrants under the company’s incentive program, the number of outstanding shares and votes has increased by 169,032 from 67,770,683 to 67,939,715. The share capital has increased by approximately SEK 18,781 from SEK 7,530,076 to SEK 7,548,857.

For further information, please contact:

Anders Martin-Löf, CFO of Oncopeptides
E-mail: [email protected] 
Telephone: +46 (0) 70 683 79 77

Rein Piir, Head of Investor Relations at Oncopeptides
E-mail: [email protected]
Cell phone: +46 70 853 72 92

The information in the press release is information that Oncopeptides is obliged to make public pursuant to the Swedish Financial Instruments Trading Act. The information was submitted for publication, through the agency of the contact persons above, on November 30, 2020 at 08.00 (CET).

About Oncopeptides


Oncopeptides is a pharmaceutical company focused on the development of targeted therapies for difficult-to-treat hematological diseases. The company is focusing on the development of the lead product candidate melflufen, a first in class peptide-drug conjugate (PDC) that targets aminopeptidases and rapidly releases alkylating agents into tumor cells. Melflufen (INN melphalan flufenamide) is in development as a new treatment for the hematological malignancy multiple myeloma and is currently being tested in multiple clinical studies including the pivotal phase 2 HORIZON study and the ongoing phase 3 OCEAN study. Based on the results from the HORIZON study Oncopeptides has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration, FDA, for accelerated approval of melflufen in combination with dexamethasone for treatment of adult patients with triple-class refractory multiple myeloma. Oncopeptides’ global Headquarters is in Stockholm, Sweden and the U.S. Headquarters is situated in Boston, Mass. The company is listed in the Mid Cap segment on Nasdaq Stockholm with the ticker ONCO. More information is available on www.oncopeptides.com.

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

https://news.cision.com/oncopeptides-ab/r/number-of-shares-and-votes-in-oncopeptides,c3244622

The following files are available for download:


https://mb.cision.com/Main/15404/3244622/1340660.pdf

Press release – Number of shares and votes in Oncopeptides

 

Cision View original content:http://www.prnewswire.com/news-releases/number-of-shares-and-votes-in-oncopeptides-301181437.html

SOURCE Oncopeptides AB

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GENFIT announces satisfactory preliminary results of its OCEANEs’ partial buyback offer

Lille (France), Cambridge (Massachusetts, United States), November 30, 2020
– GENFIT (Nasdaq and Euronext: GNFT) a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and chronic liver diseases, today announces that:

  • the reverse book building process for the partial buyback of GENFIT’s 6,081,081 convertible bonds maturing in October 2022 (“OCEANEs”) achieved satisfactory results and ended on November 27, 2020 (COB) as planned;
     
  • the Bond Purchase Agreements from investors having tendered their OCEANEs will be collected as quickly as possible and once the process is completed, GENFIT will communicate the final results of the partial buyback.

ABOUT GENFIT

GENFIT is a late-stage biopharmaceutical company dedicated to improving the lives of patients with cholestatic and metabolic chronic liver diseases. GENFIT is a pioneer in the field of nuclear receptor-based drug discovery, with a rich history and strong scientific heritage spanning more than two decades. GENFIT is currently enrolling in a Phase 3 clinical trial evaluating elafibranor in patients with primary biliary cholangitis (PBC). As part of GENFIT’s comprehensive approach to clinical management of patients with liver disease, the Company is also developing NIS4™, a new, non-invasive blood-based diagnostic technology which could enable easier identification of patients with at-risk NASH.  NIS4™ technology has been licensed to LabCorp in the U.S. and Canada for the development and commercialization of a blood-based molecular diagnostic test powered by NIS4™ technology. GENFIT has facilities in Lille and Paris, France, and Cambridge, MA, USA. GENFIT is a publicly traded company listed on the Nasdaq Global Select Market and on compartment B of Euronext’s regulated market in Paris (Nasdaq and Euronext: GNFT). www.genfit.com

FORWARD LOOKING STATEMENTS

This press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995, with respect to GENFIT, including statements regarding our capacity to renegotiate the terms of our OCEANEs and that the final terms of this proposal will be approved by the shareholders’ general meeting and general meeting of OCEANEs’ holders. The use of certain words, including “believe,” “potential,” “expect” and “will” and similar expressions, is intended to identify forward-looking statements.  Although the Company believes its expectations are based on the current expectations and reasonable assumptions of the Company’s management, these forward-looking statements are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking statements. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, biomarkers, progression of, and results from, its ongoing and planned clinical trials, review and approvals by regulatory authorities of its drug and diagnostic candidates, exchange rate fluctuations and the Company’s continued ability to raise capital to fund its development, as well as those risks and uncertainties discussed or identified in the Company’s public filings with the French Autorité des marchés financiers (“AMF”), including those listed in Section 4 “Main Risks and Uncertainties” of the Company’s 2019 Universal Registration Document filed with the AMF on May 27, 2020 under n° D.20-0503, which is available on GENFIT’s website (www.genfit.com) and on the website of the AMF (www.amf-france.org) and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s 20-F dated May 27, 2020. In addition, even if the Company’s results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods.  These forward-looking statements speak only as of the date of publication of this document. Other than as required by applicable law, the Company does not undertake any obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise.

CONTACT

GENFIT | Investors

Naomi EICHENBAUM – Investor Relations | Tel: +1 (617) 714 5252 | [email protected]

PRESS RELATIONS | Media

Hélène LAVIN – Press relations | Tel: +333 2016 4000 | [email protected]

GENFIT | 885 Avenue Eugène Avinée, 59120 Loos – FRANCE | +333 2016 4000 | www.genfit.com       

Attachment



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Voyager Digital Reports Fiscal 2021 First Quarter Results and Provides Business Update

PR Newswire

CSE: VYGR
OTCQB: VYGVF
Borse Frankfurt: UCD2

–  Grows quarterly revenue almost 200% sequentially-
– Current AUM over $150 Million, 50% growth in less than a month –

NEW YORK, Nov. 30, 2020 Voyager Digital Ltd. (“Voyager” or the “Company”) (CSE: VYGR) (OTCQB: VYGVF) (FRA: UCD2), a publicly traded, licensed crypto-asset broker that provides investors with a turnkey solution to invest in crypto assets, today announced select financial results for its fiscal 2021 first quarter ended September 30, 2020 and is pleased to provide shareholders with a business and operational update.

For more detailed information, the Company encourages investors to read its interim financial statements and related Management Discussion & Analysis (“MD&A”) for the three months ended September 30, 2020, which will be filed with SEDAR today.

“Our strong fiscal 2020 momentum carried over into the first fiscal quarter of 2021, where we saw record revenue and customer asset growth,” said Stephen Ehrlich, Co-founder and CEO of Voyager. “As a result of the continued adoption of our trusted and secure platform, our revenue grew approximately 200% on a sequential basis during the September quarter. More recently, our Assets Under Management (AUM) exceeded $150 million, up significantly from the $100 million we reported on November 6th. Voyager’s business is built to scale and excel in both up and down markets, as customers tend to trade when the markets move in either direction. Additionally when markets are flat, Voyager still earns revenue on account balances due to our interest model.”

Mr. Ehrlich continued, “We have seen the acceleration of mainstream acceptance of cryptocurrencies as an asset class, and customers are increasingly turning to our platform to do their investing, as users of the platform have already increased over 20% since September. Customers are increasingly joining us at Voyager, where they can trade commission-free and earn interest on over 50 digital assets. Notably, while the rise of Bitcoin and other cryptocurrencies has contributed to our AUM growth, more than 65% of the growth is driven by increased user deposits.”

Financial and Operational Milestones During & Subsequent to First Quarter 2021 Ended September 30, 2020

  • Revenue grew 200% to approximately USD$2.0 million, for the fiscal quarter ended September 30, 2020, compared to USD$700,000 for the previous quarter
  • Revenue for the quarter of approximately USD$2.0mm is an increase from USD$70,000 from the quarter ended September 30, 2019
  • Completed a C$5.7 million private placement, consisting of a C$5.3 million brokered placement of special warrants and a concurrent C$0.4 million non-brokered private placement in November 2020, Assets Under Management (AUM) surpassed USD$150 million, up from USD$5 million at the end of December 2019, representing a 30x increase over a period during which Bitcoin increased just under 2.5x in value

Recent Business Milestones

  • Net deposits continue to set daily records, averaging in excess of USD$750,000 per day during November 2020, up 10x from June 2020.
  • Company surpasses USD$1 million of monthly revenue for the first time during November 2020
  • Added the 52nd digital asset and 10th DeFi asset to Voyager’s commission-free crypto trading platform
  • Increased Voyager’s interest offering to 22 assets, up from 14 assets at June 30, 2020
  • Added new institutional offering, expanding Voyager’s reach to corporate treasury desks and institutional accounts
  • Expanded management team with the addition of Evan Psaropoulos as Chief Financial Officer, Michael Legg as Head of Communications, and Lewis Bateman as Head of Business Development and International Strategy
  • Formed an advisory relationship with NBA Hall of Famer Tracy McGrady, helping to educate investors about Voyager’s industry-leading interest program, offering up to 9.5% interest on various digital assets
  • Announced the acquisition of LGO, SAS, an AMF regulated entity which provides Voyager a fully licensed European entity to expedite our European strategy. The deal is expected to close by year end
  • Awarded The People’s Choice Award at the 6th annual 2020 Benzinga Global FinTech Awards in November 2020

Mr. Ehrlich added, “In fiscal 2021, we will keep improving our platform so we can continue to provide our customers with a superior digital asset investing experience. This includes the development of debit and credit cards, margin products, desktop, and continued expansion of our industry-leading interest program, which currently includes 22 interest-bearing assets. In addition to adding new features and implementing platform enhancements, we are also focused on expanding internationally and ultimately bringing the Voyager App to investors across the globe. We are thrilled with our progress so far, and our team remains committed to growing Voyager even further and providing our loyal customers the best trading experience for their crypto assets.”

For more information on Voyager Digital, please visit https://www.investvoyager.com. The Voyager App is available for Android and iPhone.

About Voyager Digital Ltd.
Voyager Digital Ltd. is a crypto-asset broker that provides retail and institutional investors with a turnkey solution to trade crypto assets. Voyager offers customers best execution and safe custody on a wide choice of popular crypto-assets. Voyager was founded by established Wall Street and Silicon Valley entrepreneurs who teamed to bring a better, more transparent and cost-efficient alternative for trading crypto-assets to the marketplace. Please visit us at https://www.investvoyager.com for more information and to review the latest Corporate Presentation.

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release. No securities regulatory authority has either approved or disapproved of the contents of this press release.

Cautionary Statement Regarding Forward-Looking Information: The forward-looking statements contained herein are made as of the date of this release and, other than as required by applicable securities laws, the Company does not assume any obligation to update or revise it to reflect new events or circumstances. There is no assurance any of the upcoming milestones listed above will be realized in the manner contemplated, or at all. The forward-looking statements contained in this release are expressly qualified by this cautionary statement.

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/voyager-digital-reports-fiscal-2021-first-quarter-results-and-provides-business-update-301181404.html

SOURCE Voyager Digital (Canada) Ltd.

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Study Comparing Two Noninvasive Indicators of Fluid Responsiveness on Mechanically Ventilated Patients Finds Masimo PVi® Effective and Advantageous

Study Comparing Two Noninvasive Indicators of Fluid Responsiveness on Mechanically Ventilated Patients Finds Masimo PVi® Effective and Advantageous

Researchers Preferred PVi for Being “Continuous, Operator-independent, and More Reliable”

NEUCHATEL, Switzerland–(BUSINESS WIRE)–Masimo (NASDAQ: MASI) announced today the findings of a study published in the Ain-Shams Journal of Anesthesiology in which Dr. Diaaeldin Aboelnile and colleagues at Ain-Shams University in Cairo, Egypt compared two noninvasive methods of assessing fluid responsiveness in mechanically ventilated patients, dIVC and Masimo PVi®. They found both methods to be “effective,” but determined that PVi was advantageous because of being “continuous, operator-independent, and more reliable than dIVC.”1 PVi, pleth variability index, is a measure of the dynamic changes in perfusion index that occur during the respiratory cycle.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201129005422/en/

Masimo Root® with PVi® (Photo: Business Wire)

Masimo Root® with PVi® (Photo: Business Wire)

Noting the importance of predicting responsiveness prior to fluid administration and the drawbacks of invasive and static methods of assessing responsiveness, the researchers sought to assess the effectiveness and reliability of PVi—which is noninvasive, dynamic, continuous, and can be measured using a pulse oximetery sensor—by comparing it to another noninvasive, but non-continuous, static method, ultrasound calculation of inferior vena cava distensibility index (dIVC). dIVC represents the percentage of variation in the inferior vena cava diameter during inspiration versus expiration. To that end, they monitored 88 adult, sedated, mechanically ventilated, intubated surgical patients using both PVi and dIVC. The patients were classified as fluid responders (48) or non-responders (40) by using the passive leg raising (PLR) test; patients whose cardiac index (CI) increased by 15% or more were considered responders. PVi was monitored using a fingertip sensor and a Masimo Radical-7® Pulse CO-Oximeter®; dIVC was measured using a Mindray M5 ultrasound probe. To assess their performance against an invasive method, the researchers also measured central venous pressure (CVP).

The researchers calculated the following results for the three parameters:

Parameter

CVP

PVi

dIVC

Threshold value

≥ 5 mmHg

> 14%

> 19.42%

Sensitivity

70.83%

93.75%

79.17%

Specificity

47.5%

87.5%

80%

Area under the curve (95% confidence interval)

0.612 (0.502-0.714)

0.955 (0.889-0.988)

0.886 (0.801-0.944)

P-value

0.0648 (“not significant”)

< 0.0001 (“highly significant”)

< 0.0001 (“highly significant”)

Based on these findings, the researchers concluded, “The results of our study showed that assessment of PVi and dIVC noninvasively were good predictors for fluid management and responsiveness prediction using PLR technique in surgical ICU mechanically ventilated patients.” They continued, “PVi and dIVC can be used in the assessment of fluid responsiveness of intubated ventilated sedated patients with sinus rhythm in the ICU, and both methods are noninvasive and can be performed at the bedside, but PVi has the advantage of being continuous, operator-independent, and more reliable than dIVC.”

@Masimo | #Masimo

The accuracy of PVi in predicting fluid responsiveness is variable and influenced by numerous patient, procedure, and device-related factors. PVi measures the variation in the plethysmography amplitude but does not provide measurements of stroke volume or cardiac output. Fluid management decisions should be based on a complete assessment of the patient’s condition and should not be based solely on PVi.

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. Our mission is to improve patient outcomes and reduce the cost of care. Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.2 Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,3 improve CCHD screening in newborns,4 and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs5-8 Masimo SET® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,9 and is the primary pulse oximetry at 9 of the top 10 hospitals according to the 2020-21 U.S. News and World Report Best Hospitals Honor Roll.10 Masimo continues to refine SET® and in 2018, announced that SpO2 accuracy on RD SET® sensors during conditions of motion has been significantly improved, providing clinicians with even greater confidence that the SpO2 values they rely on accurately reflect a patient’s physiological status. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVi®), RPVi™ (rainbow® PVi), and Oxygen Reserve Index (ORi™). In 2013, Masimo introduced the Root® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine® Brain Function Monitoring, O3® Regional Oximetry, and ISA™ Capnography with NomoLine® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7® and Radius PPG™, portable devices like Rad-67™, fingertip pulse oximeters like MightySat® Rx, and devices available for use both in the hospital and at home, such as Rad-97®. Masimo hospital automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris Gateway®, Patient SafetyNet, Replica™, Halo ION™, UniView™, UniView: 60™, and Masimo SafetyNet™. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature/.

ORi and RPVi have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

  1. Aboelnile D, Elseidy M, Kenawey Y, Elsherif I. Prediction of fluid responsiveness in mechanically ventilated patients in surgical intensive care unit by pleth variability index and inferior vena cava diameter. Ain-Shams J Anesth. 2020. 12:48. https://doi.org/10.1186/s42077-020-00097-4.
  2. Published clinical studies on pulse oximetry and the benefits of Masimo SET® can be found on our website at http://www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
  3. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
  4. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;Jan 8;338.
  5. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
  6. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
  7. McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
  8. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
  9. Estimate: Masimo data on file.
  10. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo PVi®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo’s unique noninvasive measurement technologies, including Masimo PVi, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; as well as other factors discussed in the “Risk Factors” section of our most recent reports filed with the Securities and Exchange Commission (“SEC”), which may be obtained for free at the SEC’s website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We do not undertake any obligation to update, amend or clarify these statements or the “Risk Factors” contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Masimo

Evan Lamb

949-396-3376

[email protected]

KEYWORDS: California Europe Switzerland United States North America

INDUSTRY KEYWORDS: Cardiology Biotechnology Health General Health Other Science Medical Devices Research Infectious Diseases Hospitals Surgery Science

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Masimo Root® with PVi® (Photo: Business Wire)
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Saniona publishes its interim report for the third quarter 2020

PRESS RELEASE

November 30, 2020

Financial highlights

Jan – Sep 2020 (Jan – Sep 2019)

  • Net revenues were SEK 4.6 M (2.7 M)
  • EBIT was SEK -97.0 M (-75.8 M)
  • Net profit/loss was SEK -117.3 M (-72.3 M)
  • Earnings per share were SEK -3.47 (-2.89)
  • Diluted earnings per share were SEK -3.47 (-2.89)

Q3 2020 (Q3 2019)

  • Net revenues were SEK 2.2 M (0.3 M)
  • EBIT was SEK -40.9 M (-26.0 M)
  • Net profit/loss was SEK -52.7 M (-27.7 M)
  • Earnings per share were SEK -1.24 (-1.00)
  • Diluted earnings per share were SEK -1.24 (-1.00)

Business highlights in Q3 2020

  • On August 10, 2020, Saniona announced the direct issue of shares raising USD $65 million (approximately SEK 567 million) with a syndicate of U.S. and international institutional investors and sector specialists. The Directed Issue was led by RA Capital Management with participation from Pontifax Venture Capital, New Leaf Venture Partners, and other U.S. and international investors including the Second Swedish National Pension Fund (AP2), the Third Swedish National Pension Fund (AP3) and the Fourth Swedish National Pension Fund (AP4).
  • On August 26, 2020, Saniona announced the expansion of its executive team with the appointments of Jason A. Amello as Chief Financial Officer, Trista Morrison as Chief Communications Officer, and Linea Aspesi as Chief Human Resources Officer.
  • On September 23, 2020, Saniona completed the exercise of warrants of series TO2, which were issued in connection with Saniona’s rights issue and directed issue in the first quarter of 2020. In total, 1,329,141 warrants of series TO2 were exercised, corresponding to a subscription rate of approx. 90 percent. Saniona will thereby receive proceeds of SEK 33.2 million (USD 3.6 million), before issue costs, which amount to approx. SEK 0.4 million.

Significant events after the reporting period

  • On October 9, 2020, Saniona announced that it received written feedback from the U.S. Food and Drug Administration (FDA) regarding pre-Investigational New Drug (IND) submissions for Tesomet in Prader-Willi Syndrome (PWS) and Hypothalamic Obesity (HO). In both indications, the FDA recommended that the clinical development program include a supportive Phase 2b study followed by a Phase 3 study. In PWS, Saniona expects to begin the Phase 2b study in the first half of 2021. In HO, Saniona is working on a plan, which it intends to present to the FDA to ensure that should Tesomet receive regulatory approval for HO, its use would be restricted only to the appropriate patients. Once this is addressed, Saniona anticipates beginning the HO Phase 2b study in the first half of 2021.
  • On November 9, 2020, Saniona announced that it had refined its pipeline to align its early-stage discovery research with its strategic focus on rare diseases. Saniona regained exclusive, global rights to its GABAa5 negative allosteric modulator program (“GABAa5 program”) from Boehringer Ingelheim, which terminated this collaboration for strategic reasons. The termination of the collaboration provided Saniona with rights to a portfolio of more than 800 molecules, and it does not impact the 2020 collaboration between Saniona and Boehringer Ingelheim, which remains ongoing. Separately, Saniona and the Treatment Research Center (TRC) at the University of Pennsylvania jointly discontinued their collaboration to develop NS2359 for cocaine addiction. Saniona will evaluate the applicability of the GABAa5 program assets and NS2359 in rare diseases.
  • On November 23, 2020, Saniona announced positive top-line results from the Phase 2 open-label extension study of Tesomet in patients with hypothalamic obesity (HO). Patients treated with Tesomet for nearly one year (24 week double-blind [DB] followed by 24 week open label extension [OLE]) demonstrated statistically significant and clinically meaningful reductions in body weight and waist circumference, as well as improvements in glycemic control. Tesomet was well tolerated, and no clinically meaningful differences in heart rate or blood pressure were observed over the course of the trial.

                                                           

“In the third quarter, we continued to transform Saniona into a fully-integrated biopharmaceutical company with the ability to discover, develop and ultimately commercialize our own innovative treatments for rare diseases. We were particularly encouraged by the positive data from the Phase 2 open-label extension study of Tesomet in HO, which we intend to discuss with FDA as we clarify the path forward in this rare indication,” said Rami Levin, President & Chief Executive Officer of Saniona. “During the quarter, one of our most important achievements was raising USD $65 million, which coupled with our existing cash resources, will fund our current operating plan into the second half of 2022, as originally planned. We believe access to U.S. patients, physicians and the U.S. financial market are critical for Saniona to unlock its long-term potential, and as such we are continuing to build our U.S. team and considering listing our shares on the U.S. Nasdaq exchange in addition to our existing listing on Nasdaq Stockholm.”

There are multiple potential advantages to a dual listing, including increased visibility and access to a greater number of potential investors, as well as potential increased liquidity (trading volume) from different markets with different macroeconomic conditions, allowing investors to purchase and sell shares on either exchange.

For more information, please contact

Trista Morrison, Chief Communications Officer, Saniona. Office: + 1 (781) 810-9227. Email: [email protected]

This information is such information as Saniona AB (publ) 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 8:00 CET on November 30, 2020.

About Saniona

Saniona is a biopharmaceutical company focused on discovering, developing, and delivering innovative treatments for rare disease patients around the world. The company’s lead product candidate, Tesomet, is in mid-stage clinical trials for the rare diseases Prader-Willi syndrome and hypothalamic obesity. Saniona also has a broad pipeline derived from its proprietary ion channel discovery platform, with lead candidate SAN711 entering Phase 1 studies for rare neuropathic disorders. Saniona intends to develop and commercialize its rare disease products internally. The company has out-licensed other programs, which may provide future supplemental revenue. Saniona is based in Copenhagen, Denmark and Boston, Mass., U.S. The company’s shares are listed on Nasdaq Stockholm Small Cap (OMX: SANION). Read more at www.saniona.com.

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