Market Newsdesk

STOCKHOLM, Nov. 27, 2020 /PRNewswire/ — Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company has submitted an application for market approval for the drug candidate Sedaconda (isoflurane), formerly known as IsoConDa, for inhaled sedation in intensive care. The application has been submitted to the German Medicines Agency BfArM and a number of other European Medicines Agencies through a so-called DCP procedure.

The application is the starting point of the review process of Sedaconda in 15 of the EU member states, including Norway. If all goes well, Sedana Medical expects an approval in the second half of 2021. After that, an application for a second group of EU countries can be submitted. Normally, it takes about six months to obtain approval for a second group of countries.

“When we get market approval for Sedaconda, we can exclusively launch the treatment inhaled sedation in Europe. The treatment consists of our drug Sedaconda, which is then approved for administration only via our medical device AnaConDa. We have chosen the name Sedaconda to strengthen the connection to Sedana Medical and to the drug’s unique area of use, sedation. At the same time, we want to communicate that the drug will be given via AnaConDa by keeping CONDA in the name,” said Christer Ahlberg, CEO of Sedana Medical.

In the United Kingdom, which due to Brexit has its own national application process, the application will be submitted separately in the first quarter of 2021. Switzerland also has its own national process, and the application will be submitted in 2021.

“As this is our first application for marketing approval for a drug, it is a crucial milestone for us as a company, but also for making the treatment inhaled sedation available for intensive care worldwide. A European approval will be a very good support in future registration processes in other markets when we work to make inhaled sedation a standard method in intensive care,” said Christer Ahlberg.

The market approval application is based on the strong results in Sedana Medical’s pivotal phase III study, SED-001. The topline results, announced in July 2020, showed that the study reached its primary goal; to show that Sedaconda (isoflurane), administered with AnaConDa, is an effective sedation method, for ventilator-intensive care patients, which is non-inferior to propofol. The results show that Sedaconda is an effective and safe sedation method.

For additional information, please contact:

Christer Ahlberg

CEO
Sedana Medical AB
Mobile: +46 70 675 33 30
E-mail: [email protected]

Sedana Medical is listed on Nasdaq First North Growth Market in Stockholm.

The company’s Certified Adviser is Erik Penser Bank, +46 8 463 83 00, [email protected]

This information is such that Sedana Medical AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact person above, on November 27, 2020 at 12.45 p.m. (CET).

About Sedana Medical

Sedana Medical AB (publ) has developed and sells the medical device AnaConDa for the administration of volatile anaesthetics. Through a combination of AnaConDa and the candidate drug IsoConDa (isoflurane), Sedana Medical provides inhaled sedation for mechanically ventilated intensive care patients. The company is working to obtain market approval in Europe for inhaled sedation in intensive care with the pharmaceutical IsoConDa® (isoflurane) during the second half of 2021.

Today, mechanically ventilated intensive care patients are sedated intravenously which leads to several challenges for both patients and care givers. Challenges that are solved by inhaled sedation. Based on an estimate of seven to eight million patients being sedated in intensive care due to mechanical ventilation globally, on average three to four days, Sedana Medical estimates the total market potential to SEK 20-30 billion, evenly distributed between the US, Europe and Asia. Three years after market approval in Europe Sedana Medical expects sales of SEK 500 million in Europe and an EBITDA margin of about 40 percent. The company has initiated a process to obtain market approval in the US in 2024. Registration activities have also been initiated in other markets outside the EU.

Sedana Medical has direct sales in the Nordic countries, Germany, Benelux, France, Great Britain and Spain as well as external distributors in parts of the rest of Europe, Australia, Canada, China, India, Israel, Japan, Mexico and South Korea. The company was founded in 2005 and is headquartered in Stockholm, Sweden, with medical device development in Ireland.

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SOURCE Sedana Medical

CARMIEL, Israel, Nov. 27, 2020 /PRNewswire/ — Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx^® plant cell-based protein expression system, and Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for review of the Company’s Biologics License Application (BLA) seeking accelerated approval of pegunigalsidase alfa (PRX–102) for the proposed treatment of adult patients with Fabry disease. The FDA extended the PDUFA action date by three months to April 27, 2021, from January 27, 2021.

As previously announced, the FDA accepted the BLA, granted Priority Review designation under FDA’s Accelerated Approval pathway, and indicated that it is not currently planning to hold an advisory committee meeting to discuss the application. Priority Review is granted to therapies that the FDA determines have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions.

The BLA submission includes a comprehensive set of preclinical, clinical, and manufacturing data compiled from the Company’s completed Phase I/II clinical trial of pegunigalsidase alfa, including the related extension study succeeding the Phase I/II clinical trial, interim clinical data from the Phase III BRIDGE switch-over study and safety data from the Company’s on-going clinical studies of PRX–102 in patients receiving 1 mg/kg every other week.

About Pegunigalsidase Alfa

Pegunigalsidase alfa (PRX–102) is an investigational, plant cell culture-expressed, and chemically modified stabilized version of the recombinant α-Galactosidase-A enzyme. Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with unique pharmacokinetic parameters. In clinical studies, PRX–102 has been observed to have a circulatory half-life of approximately 80 hours. The Company designed PRX–102 to potentially address the continued unmet clinical need in Fabry patients.

About Protalix BioTherapeutics, Inc.

Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx^®. Protalix was the first company to gain FDA approval of a protein produced through plant cell-based in suspension expression system. Protalix’s unique expression system represents a new method for developing recombinant proteins in an industrial-scale manner.

Protalix’s first product manufactured by ProCellEx, taliglucerase alfa, was approved for marketing by the FDA in May 2012 and, subsequently, by the regulatory authorities of other countries. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights for taliglucerase alfa, excluding Brazil, where Protalix retains full rights.

Protalix’s development pipeline consists of proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human α–Galactosidase–A protein for the proposed treatment of Fabry disease; OPRX–106, an orally-delivered anti-inflammatory treatment; alidornase alfa for the treatment of Cystic Fibrosis; and others. Protalix has partnered with Chiesi Global Rare Diseases, both in the United States and outside the United States, for the development and commercialization of pegunigalsidase alfa.

About Chiesi Global Rare Diseases

Chiesi Global Rare Diseases is a business unit of the Chiesi Group established in February 2020 and focused on research and development of treatments for rare and ultra-rare disorders. The Global Rare Diseases unit works in collaboration with Chiesi Group to harness the full resources and capabilities of our global network to bring innovative new treatment options to people living with rare diseases, many of whom have limited or no treatments available. The unit is also a dedicated partner with global leaders in patient advocacy, research and patient care. For more information visit www.chiesiglobalrarediseases.com.

About Chiesi Group

Based in Parma, Italy, Chiesi Farmaceutici is an international research-focused healthcare group with 85 years of experience in the pharmaceutical industry and a global presence in 29 countries. Chiesi researches, develops, and markets innovative drugs in the respiratory therapeutics, specialist medicine, and rare disease areas. Its R&D organization is headquartered in Parma (Italy), and is integrated with R&D groups in France, the USA, the UK, and Sweden to advance Chiesi’s pre-clinical, clinical, and registration programs. Chiesi employs nearly 6,000 people. Chiesi Group is a certified Benefit Corporation. For more information www.chiesi.com.

Forward-Looking Statements

To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. The terms “expect,” “anticipate,” “believe,” “estimate,” “project,” “plan,” “should” and “intend,” and other words or phrases of similar import are intended to identify forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk and the final results of a clinical trial may be different than the preliminary findings for the clinical trial. Factors that might cause material differences include, among others: Risks related to the timing, progress and likelihood of final approval by the FDA of the BLA for PRX–102, by the PDUFA date or at all, which was accepted by the FDA and granted Priority Review designation in August 2020 and, if approved, whether the use of PRX–102 will be commercially successful; failure or delay in the commencement or completion of our preclinical and clinical trials which may be caused by several factors, including: risks that the FDA will request additional data or other conditions of our submission of any application for Accelerated Approval of PRX–102; slower than expected rates of patient recruitment; unforeseen safety issues; determination of dosing issues; lack of effectiveness during clinical trials; inability to monitor patients adequately during or after treatment; and inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; risks associated with the novel coronavirus disease (COVID–19) outbreak, which may adversely impact our business, preclinical studies and clinical trials; the risk that the results of the clinical trials of our product candidates will not support our claims of safety or efficacy, that our product candidates will not have the desired effects or will be associated with undesirable side effects or other unexpected characteristics; risks related to our ability to maintain and manage our relationship with Chiesi Farmaceutici and any other collaborator, distributor or partner; risks related to the amount of our future revenues and expenditures, and related milestones under our supply and technology transfer agreement; the risk that despite the FDA’s grant of Fast Track designation for PRX–102, we may not experience a faster development process, review or approval compared to applications considered for approval under conventional FDA procedures; risks related to the FDA’s ability to withdraw the Fast Track designation at any time; our dependence on performance by third party providers of services and supplies, including without limitation, clinical trial services; the inherent risks and uncertainties in developing drug platforms and products of the type we are developing; the impact of development of competing therapies and/or technologies by other companies and institutions; potential product liability risks, and risks of securing adequate levels of product liability and other necessary insurance coverage; and other factors described in our filings with the U.S. Securities and Exchange Commission. The statements in this press release are valid only as of the date hereof and we disclaim any obligation to update this information, except as may be required by law.

Investor Contact

Chuck Padala, Managing Director
LifeSci Advisors
+1-646-627-8390
[email protected]

Media Contact

Bill Berry

Berry & Company Public Relations
+1-917-846-3862
[email protected]

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SOURCE Protalix BioTherapeutics, Inc.; Chiesi

CHANGZHOU, China, Nov. 27, 2020 /PRNewswire/ — On 25 November 2020, Trina Solar Limited Vertex S 400W+ series of ultra-high power compact modules successfully completed all necessary reliability tests and have obtained the IEC 61215 and IEC 61730 certificates. Following the two certificates awarded to the Vertex 550W/600W in October 2020 relating to IEC 61215 photovoltaic modules performance standards and IEC 61730 photovoltaic modules safety standards, this is another milestone for Trinasolar’s ultra-high power modules.

The Vertex series contains new generation high-efficiency photovoltaic modules designed especially by Trinasolar for application in distributed housing and commercial building roofs. The products adopt technologies such as 210mm batteries, multi-busbars, non-destructive cutting and high-density packaging, with a maximum power output exceeding 405W+ and module conversation rate exceeding 21%. Compared with traditional home modules in the market, Vertex S boasts core advantages like a smaller size profile, lightweight build, high power, high efficiency, high power generation, flexible installation, good system adaptability, reliability, convenience in transportation, and environmental friendliness. Different exterior designs offer more choices, meeting the diverse needs of both residential and commercial customers. Calculation shows that for a pitched roof of 10m*5m, if Vertex 405W products are adopted, an installed capacity of 10.935kW can be achieved, which will be reduced to 10.125kW if the 6*10 375 modules of 166 silicon wafers are used. Take Shandong for example, the 0.81kW extra capacity can generate extra power of 1053kWh, bringing more return for users.

The Vertex series is compatible with the existing mainstream support system, optimizer and inverter in residential and commercial applications. The product is 1754 x 1096mm in size, and weighs 21kg. Within the working range of the electrical parameters of mainstream home and industrial/commercial inverters, Vertex maintains a module form and weight that enables easy rooftop installation. The newly launched series consists of three products: Silver Border DE09, Black Aesthetics DE09.05 and Black Border DE09.08. These products can satisfy the diverse needs of different regions and customers. To meet the demands of the global market for ultra-high power modules (including the Vertex series), Trinasolar’s planned module production capacity for 2021 is intended to exceed 50GW.

Zou Chicheng, Solar Energy Service VP of TÜV Rheinland Greater China, said, “We are very happy to see that Trinasolar has completed the industrialization and reliability tests for the 400W+ distribution modules. Trinasolar has many forward-facing designs and mass production plans for the application of ultra-high power module products in the distribution area. Congratulations to Trinasolar. We look forward to working with Trinasolar again.”

Vice President, Global Sales, Marketing & Product Management of Trinasolar Helena Li Yan remarked, “Trinasolar’s customers have always attached importance to product performance and quality. Our Vertex products suit the needs of the customers in the distribution market very well. After the products were announced, we have received many enquiries, and many customers have expressed strong purchase intention. Both our existing and new customers are eagerly waiting for the Vertex products to be officially available on the market.”

About Trina Solar

 

Founded in 1997, Trina Solar is the world leading PV and smart energy total solution provider. The company engages in PV products R&D, manufacture and sales; PV projects development, EPC, O&M; smart micro-grid and multi-energy complementary systems development and sales, as well as energy cloud-platform operation. In 2018, Trina Solar launched Energy IoT brand, established the Trina Energy IoT Industrial Development Alliance together with leading enterprises and research institutes in China and around the world, and founded the New Energy IoT Industrial Innovation Center. With these actions, Trina Solar is committed to working with its partners to build the energy IoT ecosystem and develop an innovation platform to explore New Energy IoT, as it strives to be a leader in global intelligent energy. For more information, please visit 

www.trinasolar.com

.
 

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SOURCE Trina Solar Co., Ltd

• On November 19, the Mexican Senate passed comprehensive adult-use cannabis legalization, moving Mexico towards becoming one of the few countries to legalize cannabis nationally
• On March 31, 2020, the Company entered into an agreement with Tecnologico de Monterrey, the leading university in Mexico, to educate physicians across Latin America, in advance of the impending regulations in Mexico
• To date, close to 550 LatAm physicians have obtained their diploma accrediting completion of Khiron’s medical education program
• The Company plans to deploy its ZereniaTM medical cannabis clinics and telehealth strategy in Mexico, building on the success of its vertical integration strategy in Colombia
• Expanding the Zerenia clinic strategy will build on the Company’s Colombia knowledge and proven distribution capabilities, with rapid telehealth service adoption and over 5,600 medical cannabis scripts filled to date
• Mexico represents one of the largest potential markets for medical cannabis in the world and is anticipated to reach $1.2bn USD by 2028 (Prohibition Partners).
• Company to release Q3 2020 financials and host webcast on Tuesday, December 1st

TORONTO, Nov. 27, 2020 /PRNewswire/ – Khiron Life Sciences Corp. (“Khiron” or the “Company”) (TSXV: KHRN), (OTCQX: KHRNF), (Frankfurt: A2JMZC), a vertically integrated cannabis leader with core operations in Latin America and Europe, welcomes the passing of adult-use cannabis legislation by the Mexican Senate, which moves the country closer to a legalized cannabis market, and towards provision for medical cannabis products.  Khiron has had a presence in Mexico since 2018 and has been working with doctors and medical institutions to develop a deep understanding of the market.

“We are pleased to see the Mexican legislative and executive branches working together to bring medical cannabis closer to a reality. At Khiron, our goal is to improve the quality of life of 1 million patients by 2024 and Mexico will play an important role in our strategy. Because of this, we partnered with Tecnologico de Monterrey to bring our medical cannabis education platform to doctors working in clinics and health centres across Mexico and LatAm. The clinic model is one we understand well and in which we have proven success. As medical cannabis regulations continue to evolve, we plan to take advantage of our vertical integration model by deploying our Zerenia medical cannabis clinic and telehealth strategy in Mexico,” comments Alvaro Torres, Khiron CEO and Director.

Webcast and Q&A
Khiron invites individual and institutional investors, as well as advisors and analysts, to attend a webcast and Q&A to discuss the Company’s Q3 2020 financial statements and further activities.
DATE: Tuesday, December 1st, 2020
TIME: 10:00am EST/7:00am PST
PRESENTERS:Alvaro Torres, CEO and Director, Joel Friedman, CFO, and Chris Naprawa, Chairman
FORMAT: Live 30 minutes presentation and Q&A session
REGISTER LINK: https://event.on24.com/wcc/r/2819768/9328DB919FFBB024F2CF5F4F5119285E 

About Khiron Life Sciences Corp.
Khiron is a vertically integrated medical and CPG cannabis company with core operations in Latin America, and operational activity in Europe and North America. Khiron is the leading cannabis company in Colombia and the first company licensed in Colombia for the cultivation, production, domestic distribution and sales, and international export of both low and high THC medical cannabis products. The Company has filled medical cannabis prescriptions in Peru and has a presence in Mexico, Uruguay, UK, Spain and also in Germany, where it is positioned to begin sales of medical cannabis.

Leveraging its first-mover advantage and patient-oriented approach, Khiron combines global scientific expertise, product innovation, agricultural infrastructure, wholly-owned medical clinics, and online doctor education programs to drive prescription and brand loyalty to address priority medical conditions. Its Wellbeing unit launched the first branded CBD skincare brand in Colombia, with Kuida^TM now marketed in multiple jurisdictions in Latin America, the US and UK. The Company is led by Co-founder and Chief Executive Officer, Alvaro Torres, together with an experienced and diverse executive team and Board of Directors.

Visit Khiron online at investors.khiron.ca and on Instagram @khironlife.

Cautionary Notes

Forward-Looking Statements

This press release may contain certain “forward-looking information” and “forward-looking statements” within the meaning of applicable securities legislation. All information contained herein that is not historical in nature may constitute forward-looking information. Khiron undertakes no obligation to comment on analyses, expectations or statements made by third-parties in respect of Khiron, its securities, or financial or operating results (as applicable). Although Khiron believes that the expectations reflected in forward-looking statements in this press release are reasonable, such forward-looking statement has been based on expectations, factors and assumptions concerning future events which may prove to be inaccurate and are subject to numerous risks and uncertainties, certain of which are beyond Khiron’s control, including the risk factors discussed in Khiron’s Annual Information Form which is available on Khiron’s SEDAR profile at www.sedar.com. The forward-looking information contained in this press release is expressly qualified by this cautionary statement and is made as of the date hereof. Khiron disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking information, whether as a result of new information, future events or otherwise.

Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this press release.

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SOURCE Khiron Life Sciences Corp.

TEL AVIV, Israel, Nov. 27, 2020 /PRNewswire/ — Ellomay Capital Ltd. (NYSE American: ELLO) (TASE: ELLO) (“Ellomay” or the “Company”), a renewable energy and power generator and developer of renewable energy and power projects in Europe and Israel, today announced that following discussions with representatives of certain shareholders, the Company is amending the Notice of the Meeting and Proxy Statement and the proxy card for the Extraordinary General Meeting scheduled for December 17, 2020 that was announced on November 12, 2020 (the “Meeting“), to separate the vote on the provision of an exemption and the grant of options to the external director nominee and to Mr. Ehud Gil, a member of the Board of Directors of the Company.

The provision of the exemption and the option grants to the external director nominee and Mr. Gil were previously included on the agenda of the Meeting as part of the resolution to approve their respective terms of service, and the Company is amending the Notice of the Meeting and Proxy Statement and the proxy card solely in order to enable shareholders to vote on the provision of the exemption and grant of options separately.

Therefore, the amended agenda of the Meeting will be as follows:

1. Election of Mr. Daniel Vaknin as a new external director for an initial three-year term
2. Approval of terms of service of Mr. Daniel Vaknin, the external director nominee;
3. Approval of grant of options to Mr. Daniel Vaknin, the external director nominee;
4. Approval of provision of an exemption to Mr. Daniel Vaknin, the external director nominee;
5. Approval of terms of service of Mr. Ehud Gil, a member of the Board of Directors;
6. Approval of grant of options to Mr. Ehud Gil, a member of the Board of Directors; and
7. Approval of provision of an exemption to Mr. Ehud Gil, a member of the Board of Directors.

The record date for the Meeting (November 17, 2020) and the Meeting date remain the same. The Company plans to mail an amended proxy statement and proxy card to record holders on or about November 30, 2020. The amended proxy statement and proxy card will also be furnished to the Securities and Exchange Commission on Form 6-K on or about November 27, 2020.

Each of the resolutions to be presented at the Meeting requires the affirmative vote of holders of at least a majority of the ordinary shares voted in person or by proxy at the Meeting on the matter presented for passage. In addition, the approval of the proposals under Items 1, 3 and 5-7 is required to comply with additional special “disinterested” voting requirements as set forth in the Proxy Statement.

About Ellomay Capital Ltd.

Ellomay is an Israeli based company whose shares are registered with the NYSE American and with the Tel Aviv Stock Exchange under the trading symbol “ELLO”. Since 2009, Ellomay Capital focuses its business in the renewable energy and power sectors in Europe and Israel.

To date, Ellomay has evaluated numerous opportunities and invested significant funds in the renewable, clean energy and natural resources industries in Israel, Italy and Spain, including:

• Approximately 7.9MW of photovoltaic power plants in Spain and a photovoltaic power plant of approximately 9 MW in Israel;
• 9.375% indirect interest in Dorad Energy Ltd., which owns and operates one of Israel’s largest private power plants with production capacity of approximately 860MW, representing about 6%-8% of Israel’s total current electricity consumption;
• 51% of Talasol, which is involved in a project to construct a photovoltaic plant with a peak capacity of 300MW in the municipality of Talaván, Cáceres, Spain;
• Groen Gas Goor B.V. and Groen Gas Oude-Tonge B.V., project companies developing anaerobic digestion plants with a green gas production capacity of approximately 375 Nm3/h, in Goor, the Netherlands and 475 Nm3/h, in Oude Tonge, the Netherlands, respectively;
• 75% of Ellomay Pumped Storage (2014) Ltd. (including 6.67% that are held by a trustee in trust for us and other parties), which is involved in a project to construct a 156 MW pumped storage hydro power plant in the Manara Cliff, Israel.

Ellomay Capital is controlled by Mr. Shlomo Nehama, Mr. Hemi Raphael and Mr. Ran Fridrich. Mr. Nehama is one of Israel’s prominent businessmen and the former Chairman of Israel’s leading bank, Bank Hapohalim, and Messrs. Raphael and Fridrich both have vast experience in financial and industrial businesses. These controlling shareholders, along with Ellomay’s dedicated professional management, accumulated extensive experience in recognizing suitable business opportunities worldwide. Ellomay believes the expertise of Ellomay’s controlling shareholders and management enables the Company to access the capital markets, as well as assemble global institutional investors and other potential partners. As a result, we believe Ellomay is capable of considering significant and complex transactions, beyond its immediate financial resources.

For more information about Ellomay, visit http://www.ellomay.com.

Information Relating to Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of the Company’s management. All statements, other than statements of historical facts, included in this press release regarding the Company’s plans and objectives, expectations and assumptions of management are forward-looking statements. The use of certain words, including the words “estimate,” “project,” “intend,” “expect,” “believe” and similar expressions are intended to identify forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The Company may not actually achieve the plans, intentions or expectations disclosed in the forward-looking statements and you should not place undue reliance on the Company’s forward-looking statements. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by the Company’s forward-looking statements, including the impact of COVID-19 virus on the Company’s operations and projects, including in connection with steps taken by authorities in countries in which the Company operates, regulatory changes, changes in the supply and prices of resources required for the operation of the Company’s facilities (such as waste and natural gas) and in the price of oil, changes in demand and technical and other disruptions in the operations or construction of the power plants owned by the Company in addition to other risks and uncertainties associated with the Company’s business that are described in greater detail in the filings the Company makes from time to time with Securities and Exchange Commission, including its Annual Report on Form 20-F. The forward-looking statements are made as of this date and the Company does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact:

Kalia Weintraub

CFO
Tel: +972 (3) 797-1111
Email: [email protected]

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SOURCE Ellomay Capital Ltd

BEIJING, Nov. 27, 2020 /PRNewswire/ — Mercurity Fintech Holding Inc. (Nasdaq: MFH) today announced its unaudited financial results for the third quarter ended September 30, 2020.

Third Quarter 2020 Financial and Operating Highlights

• Q3 2020 GAAP revenues of $41 thousand, compared to $580 thousand in Q3 2019.
• Q3 2020 GAAP gross profit of $11 thousand, compared to $464 thousand in Q3 2019.
• Q3 2020 GAAP net loss of $631 thousand, compared to a profit of $396 thousand in Q3 2019.
• Q3 2020 Non-GAAP net loss of $427 thousand, compared to $396 net income in Q3 2019.

Commenting on the quarter, Ms. Alva Zhou, Chairperson of the Board and Chief Executive Officer, said, “As challenges of the pandemic persist and due to our new focus on capturing the opportunity of the digital assets industry, the Q3 2020 operating results reflect the stage of our initial business transition. We are building our team and products to execute this strategic transition.”

Mr. Erez Simha, Chief Financial Officer and Interim President of the company, commented, “I joined the company in late August this year because I believe in the tremendous opportunity that the digital assets industry represents. Since I joined, I have been working with our executive teams to analyze our potential addressable markets, forming our business strategy, aligning our product road map and building a team that is necessary to execute it. We have launched and introduced our DeFi platform earlier this month and plan to introduce additional products linked to our DeFi platform in the next few months. We will invest majority of our resources and focus on bringing a comprehensive DeFi offering to the market.”

FINANCIAL RESULTS

Summary of Third Quarter Results:

Revenues for the third quarter of 2020 were $41 thousand compared to $580 thousand in the same period last year. The revenues for the third quarter of 2020 consisted of software development fees earned from a new client who entered into a contract with the company in July 2020. The software development and maintenance contracts signed in 2019 were completed in the second quarter of 2020.

Cost of revenues for the third quarter of 2020 were $30 thousand, compared to $116 thousand in the same period last year. The cost of revenues consisted primarily of the direct cost related to the contract signed in July 2020. 

Gross profit for the third quarter of 2020 was $11 thousand, compared to $464 thousand in the same period last year.

General and administrative expenses for the third quarter of 2020 were $644 thousand, compared to $87 thousand in the same period last year. The general and administrative expenses consisted primarily of employee’s costs, office expenses and professional fees. The increase in general and administrative expenses primarily reflected increases in employees’ costs and office expenses as a result of our acquisition of NBpay Investment Limited in March 2020.  In the third quarter of 2020, share-based compensation of approximately $204 thousand was included in employees’ costs and professional fees.

Loss from operations for the third quarter of 2020 was $633 thousand compared to income from operations of $377 thousand in the same period last year.

Loss before provision for income taxes for the third quarter of 2020 was $631 thousand compared to an income before taxes of $396 thousand in the same period last year.

Non-GAAP net (loss)/income attributable to Mercurity Fintech Holding Inc. is a non-GAAP measure which excludes amortization of acquired intangible assets, impairment loss, share-based compensation, and related provision for income tax expenses. Non-GAAP net loss attributable to Mercurity Fintech Holding Inc. for the third quarter of 2020 was $427 thousand compared to a net income of $396 thousand in the same period of last year.

Cash and cash equivalents as of September 30, 2020 were $187 thousand, compared to $435 thousand as of December 31, 2019.

Total shareholders’ equity as of September 30, 2020 was $11.2 million, compared to total shareholders’ equity of $8.0 million as of December 31, 2019.

Non-GAAP Measures

To supplement the Company’s consolidated financial statements presented in accordance with U.S. generally accepted accounting principles (“U.S.GAAP”), the Company uses non-GAAP financial measures, including Non-GAAP (loss)/income from continuing operations and Non-GAAP net (loss)/income attributable to the Company, that are adjusted from results based on U.S. GAAP to exclude amortization of acquired intangible assets, impairment loss, share-based compensation and related provision for income tax expenses. The non-GAAP financial information is provided as additional information to help investors compare business trends among different reporting periods on a consistent basis and to enhance investors’ overall understanding of the historical and current financial performance of the Company’s operations and prospects for the future. The non-GAAP financial information should be considered in addition to results prepared in accordance with U.S. GAAP but should not be considered a substitute for or superior to U.S. GAAP financial results. In addition, the Company’s calculation of this non-GAAP financial information may be different from the calculation used by other companies, and therefore comparability may be limited. A limitation of using these non-GAAP financial measures is that amortization of acquired intangible assets, impairment of goodwill, share-based compensation and related provision for income tax benefits have been and may continue to be for the foreseeable future significant recurring expenses in the Company’s results of operations. The Company compensates for these limitations by providing reconciliations of non-GAAP financial measures to U.S. GAAP financial measures. Please see the reconciliation tables at the end of this earnings release.

BUSINESS OUTLOOK

Due to uncertainty as a result of the continued global pandemic and new product development, the Company will not provide a financial forecast for Q4 2020.

SAFE HARBOR STATEMENT

This announcement contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “aim,” “anticipate,” “believe,” “estimate,” “expect,” “hope,” “going forward,” “intend, ” “ought to, ” “plan, ” “project,” “potential,” “seek,” “may,” “might,” “can,” “could,” “will,” “would,” “shall,” “should,” “is likely to” and the negative form of these words and other similar expressions. Among other things, statements that are not historical facts, including statements about the Company’s beliefs and expectations are or contain forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement. All information provided in this press release is as of the date of this press release and is based on assumptions that the Company believes to be reasonable as of this date, and the Company does not undertake any obligation to update any forward-looking statement, except as required under applicable law.

CONTACTS

Xingyan Gao

Mercurity Fintech Holding Inc.
[email protected]
Tel: +86 (10) 5360-6428

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SOURCE Mercurity Fintech Holding Inc.

SAN JOSE, Calif. and WESTBURY, N.Y., Nov. 27, 2020 /PRNewswire/ — QuantumScape Corporation (“QuantumScape”), a leader in the development of next generation solid-state lithium-metal batteries for use in electric vehicles, announced today that it has completed its business combination with Kensington Capital Acquisition Corp. (“Kensington“) (NYSE: KCAC), a special purpose acquisition company. The Business Combination was approved by Kensington stockholders in a special meeting held on November 25, 2020. Beginning on November 27, 2020, QuantumScape shares will trade on the NYSE under the ticker symbol “QS” and its warrants will trade on the NYSE under the ticker symbol “QS.W”.

Since the company was founded in 2010, QuantumScape has been exclusively focused on developing solid-state batteries and designing a scalable manufacturing process to commercialize its battery technology for the automotive industry. Through its elegant “anode-less” design, QuantumScape’s solid-state lithium-metal batteries are designed to be safer, and to deliver greater range, faster charge times and improved cycle life, than today’s conventional lithium-ion battery technology.  

“Today marks a big step in the evolution of our company,” commented Jagdeep Singh, Founder and Chief Executive Officer of QuantumScape. “This transaction allows QuantumScape to fund development and commercialization of our OEM-validated battery technology as we look forward to playing our part in the electrification of the automotive powertrain, helping transform one of the world’s largest industries and fostering a cleaner future for all.” 

Justin Mirro, Chairman and Chief Executive Officer of Kensington, added, “we are incredibly excited to complete our business combination with QuantumScape and to provide the company with significant capital and automotive guidance to accelerate its business plan.  The adoption of electric vehicles has emerged as the global mega-trend in the automotive industry, and QuantumScape is now well positioned to become a leading supplier of solid-state batteries for this next generation of electric powertrains.”

The transaction will result in net proceeds of approximately $680 million to QuantumScape, including through a $500 million fully committed PIPE. Funds from the transaction are expected to fully support the company through the start of production in the second half of 2024.

Hughes Hubbard & Reed LLP served as legal advisor and UBS Investment Bank, Stifel Nicolaus & Company Incorporated and Robert W. Baird & Co. Incorporated served as financial advisors to Kensington. Goldman Sachs & Co. LLC and UBS Investment Bank served as joint placement agents on the PIPE offering. Wilson Sonsini Goodrich & Rosati served as legal advisor and Goldman Sachs & Co. LLC served as financial advisor to QuantumScape.

About QuantumScape Corporation
QuantumScape, founded in 2010 in California, is a leader in the development of next generation solid-state lithium-metal batteries for use in electric vehicles.  The company’s mission is to revolutionize energy storage to enable a sustainable future. 

For additional information, please visit www.quantumscape.com

About Kensington Capital Acquisition Corp.
Kensington Capital Acquisition Corp. (NYSE: KCAC) is a special purpose acquisition company formed for the purpose of effecting a business combination in the automotive sector. Kensington is sponsored by Kensington Capital Partners LLC and the management team of Justin Mirro, Bob Remenar, Simon Boag and Daniel Huber. Kensington is also supported by a board of independent directors including Tom LaSorda, Anders Pettersson, Mitch Quain, Don Runkle and Matt Simoncini. The Kensington team has completed over 70 automotive transactions and has over 300 years of combined experience leading some of the largest automotive companies in the world.

For additional information, please visit www.autospac.com.

Forward Looking Statements
The information in this press release includes “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of present or historical fact included in this presentation, regarding Kensington’s proposed acquisition of QuantumScape, Kensington’s ability to consummate the transaction, the development and performance of QuantumScape’s products (including the timeframe for development of such products), the benefits of the transaction and the combined company’s future financial performance, as well as the combined company’s strategy, future operations, estimated financial position, estimated revenues and losses, projected costs, prospects, plans and objectives of management are forward-looking statements. When used in this press release, the words ‘are designed to,” “could,” “should,” “will,” “may,” “believe,” “anticipate,” “intend,” “estimate,” “expect,” “project,” the negative of such terms and other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain such identifying words. These forward-looking statements are based on management’s current expectations and assumptions about future events and are based on currently available information as to the outcome and timing of future events. Except as otherwise required by applicable law, QuantumScape disclaims any duty to update any forward-looking statements, all of which are expressly qualified by the statements in this section, to reflect events or circumstances after the date of this press release. QuantumScape cautions you that these forward-looking statements are subject to numerous risks and uncertainties, most of which are difficult to predict and many of which are beyond the control of either Kensington or QuantumScape. In addition, QuantumScape cautions you that the forward-looking statements contained in this press release are subject to the following factors: (i) QuantumScape’s ability to realize the anticipated benefits of the business combination, which may be affected by, among other things, competition and the ability of QuantumScape to grow and manage growth profitably following the business combination; (ii) risks relating to the outcome and timing of the Company’s development of its battery technology and related manufacturing processes; (iii) the possibility that QuantumScape may be adversely affected by other economic, business, and/or competitive factors; and (iv) the possibility that the expected timeframe for, and other expectations regarding the development and performance of, QuantumScape’s products will differ from current assumptions. Should one or more of the risks or uncertainties described in this press release, or should underlying assumptions prove incorrect, actual results and plans could different materially from those expressed in any forward-looking statements. Additional information concerning these and other factors that may impact the operations and projections discussed herein can be found in Kensington’s periodic filings with the SEC.  Kensington’s SEC filings are available publicly on the SEC’s website at www.sec.gov.

Contacts:

For Investors

[email protected]

For Media

[email protected]

For Kensington Capital Acquisition Corp.

Dan Huber

Chief Financial Officer
[email protected]
703-674-6514

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SOURCE Kensington Capital Acquisition Corp.

LUND, Sweden, Nov. 27, 2020 /PRNewswire/ — BioInvent International AB’s (publ) (“BioInvent”) (OMXS: BINV) Extraordinary General Meeting (the “EGM”) today resolved to approve the Board of Directors’ resolution on a directed issue of 29,395,311 new shares and 14,697,655 new warrants to CASI Pharmaceuticals Inc. including amendments of the Articles of Association, resolved on a reverse share split 1:25 and a reduction of the share capital with necessary amendments to the Articles of Association and authorized the Board of Directors to resolve on a new shares issue of a maximum of 109,378,025 shares (corresponding to 4,375,121 shares after the reverse share split).

The EGM resolved on amendment of § 4 (share capital) and § 5 (number of shares) of the Articles of Association for the purpose of enabling the directed issue of shares and warrants, as resolved by the Board of Directors on 27 October 2020 subject to the approval by the EGM. § 4 is amended in such way that the share capital shall amount to no less than 22,400,000 Swedish kronor (SEK) and no more than 89,600,000 Swedish kronor (SEK) (previously no less than 20,000,000 Swedish kronor (SEK) and no more than 80,000,000 Swedish kronor (SEK)).

The EGM resolved to approve the Board of Directors’ previous resolution on October 27, 2020 on a directed issue of 29,395,311 new shares and 14,697,655 new warrants of series 2020/2025, both to CASI Pharmaceuticals, Inc. Through the issue of the new shares, the share capital of the company will increase by SEK 2,351,624.88 and at the subscription for new shares following exercise of the warrants of series 2020/2025, the share capital of the company may increase by maximum SEK 1,175,812.40. The subscription price for each new share shall be SEK 2.09 per share and the warrants are issued at no separate option premium. Subscription can only take place of all shares and warrants together and thus not of shares or warrants separately. One (1) warrant entitle the warrant holder to subscribe for one (1) new share in the company at a subscription price of SEK 3.14 per share during the period from and including 27 November 2020 up to and including 27 November 2025. The new shares are expected to be admitted to trading around December 7, 2020.

Furthermore, the EGM resolved on a reverse share split and amendment of § 5 (number of shares) of the Articles of Association. The reverse share split will be carried out by twenty-five (25) existing shares consolidating into one (1) new share (Sw. sammanläggning 1:25). If a shareholders’ holding of shares does not correspond to a full number of new shares, the excessive shares will pass to the company at the record date of the reverse share split. Excessive shares will thereafter be sold by Aktieinvest FK AB appointed by the company at the company’s expense, whereby concerned shareholders will receive their part of the sales proceeds. The EGM also resolved to authorize the Board of Directors to determine the record date for the reverse share split. The intention is to carry out the reverse share split during December 2020 and more detailed information about the timetable is expected to be announced no later than the second week in December. Following the reverse share split, the number of shares in the company will decrease from 984,402,407 to 39,376,096. The reversed share split will result in a change of the share’s par value from SEK 0.08 to approximately SEK 2.00. The resolution on amendment of the Articles of Association means that § 5 is amended in such way that the number of shares shall be not less than 37,500,000 and not more than 150,000,000 (previously not less than 280,000,000 and not more than 1,120,000,000).

The EGM also resolved on a reduction of the share capital and amendment of § 4 (share capital) of the Articles of Association. The share capital shall be reduced by SEK 70,876,973.36. Following the reduction, the share capital amounts to SEK 7,875,219.20, allocated on in total 39,376,096 shares, each share with a quota value of SEK 0.20. The reduction amount shall be allocated to unrestricted shareholders’ equity and shall be made without retirement of shares. The reduction of the share capital requires authorization from the Swedish Companies Registration Office (Sw. Bolagsverket) or a court of general jurisdiction. Provided that the required authorization is obtained, the resolution on the reduction will be implemented in March 2021. The resolution on amendment of the Articles of Association means that § 4 is amended in such way that the share capital shall amount to no less than 7,500,000 Swedish kronor (SEK) and no more than 30,000,000 Swedish kronor (SEK) (previously no less than 22,400,000 Swedish kronor (SEK) and no more than 89,600,000 Swedish kronor (SEK)).

Finally, the EGM resolved to authorize the Board of Directors to, on one or several occasions during the period up to the next Annual General Meeting, resolve on the issue of a maximum of 109,378,025 shares (corresponding to 4,375,121 shares after the reverse share split). The issue may take place with or without a deviation from the shareholders’ preferential right and against payment in cash or with or without provisions on contribution in kind or set-off or any other terms. The purpose of the authorization is to increase the company’s financial flexibility and enable acquisitions by payment of shares. The above authorization replaces the authorization the Board of Directors was granted at the Annual General Meeting 2020, regarding the time after the resolution of the general meeting at this EGM.

The minutes from the extraordinary general meeting will be available on the company’s website, www.bioinvent.com.

About BioInvent

BioInvent International AB (OMXS: BINV) is a clinical stage company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapies, with two ongoing programs in Phase l/ll clinical trials for the treatment of hematological cancer and solid tumors, respectively. Two preclinical programs in solid tumors are expected to have entered clinical trials by the end of 2020. The company’s validated, proprietary F.I.R.S.T™ technology platform simultaneously identifies both targets and the antibodies that bind to them, generating many promising new drug candidates to fuel the company’s own clinical development pipeline or for additional licensing and partnering.

The company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the company’s fully integrated manufacturing unit. More information is available at www.bioinvent.com.

For further information, please contact:

Martin Welschof, CEO 
+46 (0)46 286 85 50  
[email protected]    

BioInvent International AB (publ)

Co. Reg. No. Org nr: 556537-7263
Visiting address: Sölvegatan 41
Mailing address: 223 70 LUND
Phone: +46 (0)46 286 85 50
www.bioinvent.com

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SOURCE BioInvent