Highlights of this day in history: Alan Shepard becomes the first American in space; France's Napoleon Bonaparte dies; Philosopher Karl Marx born; IRA member Bobby Sands during a prison hunger strike; Carnegie Hall opens in New York. (May 5)
Highlights of this day in history: Alan Shepard becomes the first American in space; France's Napoleon Bonaparte dies; Philosopher Karl Marx born; IRA member Bobby Sands during a prison hunger strike; Carnegie Hall opens in New York. (May 5)
Amritsar (Punjab) [India], May 14 (ANI): Amid a surge in COVID-19, people in most parts of the country offered namaz at their homes while in Punjab people gathered in large numbers at Amritsar's Jama Masjid Khairuddin Hall Bazar to offer namaz on the occasion of Eid ul-Fitr on Friday.
New Delhi [India], May 14 (ANI): As many as 3,43,144 new COVID-19 cases and 3,44,776 recoveries were reported in India in the last 24 hours, the Union Health Ministry reported on Friday, taking the total cases in the country to 2,40,46,809.
A former Army Green Beret who admitted divulging military secrets to Russia over a 15-year period is scheduled to be sentenced on espionage charges. Peter Dzibinski Debbins, 46, of Gainesville, Virginia, pleaded guilty in November to a federal Espionage Act charge in U.S. District Court in Alexandria. Debbins' relationship with Russian intelligence dates to 1996 and spanned 15 years.
Joining us for today's call are AudioEye's interim CEO, Mr. David Moradi; executive chairman, Dr. Carr Bettis; and CFO, Mr. Before I turn the call over to AudioEye's executive chairman, the company would like to remind all participants that statements made by AudioEye management during the course of this conference call that are not historical facts are considered to be forward-looking statements.
Joining me on the call are Dr. Harry Stylli, chairman and chief executive officer; and Eric d'Esparbes, chief financial officer. Before I turn the call over to Dr. Stylli, I would like to remind you that today's call will include forward-looking statements within the meaning of the federal securities laws, including but not limited to the types of statements identified as forward-looking in our quarterly report on Form 10-Q that we will file later today and our subsequent periodic reports filed with the SEC, which will all be available on our website in the investor section.
Good afternoon, everyone, and thank you again for joining us in the StoneMor, Inc. conference call to discuss our 2021 first-quarter financial results. With us on the call this afternoon are Joe Redling, president and chief executive officer; and Jeffrey DiGiovanni, senior vice president and chief financial officer.
Image source: The Motley Fool. Vivint Smart Home, Inc. (NYSE: VVNT)Q1 2021 Earnings CallMay 13, 2021, 5:00 p.m. ETContents: Prepared Remarks Questions and Answers Call Participants Prepared Remarks: OperatorGood day, and thank you for standing by.
Workers need time off to stay happy and engaged with their work – denying them this can seriously backfire for businesses.
Regulated Information Nyrstar NV 2020 Full Year Results 14 May 2021 at 07:00 CEST Nyrstar NV ("Nyrstar" or the “Company”) is today announcing the publication of its financial statements for the twelve months ended 31 December 2020 (“Full Year Results 2020”). The Full Year Results 2020 have been prepared on a discontinuity basis as a result of the decision of the extraordinary shareholders’ meeting of 9 December 2019 to reject the continuation of the Company’s activities. The Company has received from its auditor, and is publishing today, an audit opinion to accompany its Full Year Results 2020. In its audit opinion, the auditor confirms that in its opinion, the annual accounts give a true and fair view of the Company’s net equity and financial position as of 31 December 2020, in accordance with the financial reporting framework applicable in Belgium. The Full Year Results 2020 and the associated reports of the Company’s board of directors have today been published in the reports and presentation section of the Nyrstar website (see https://www.nyrstar.be/en/investors/results-reports-and-presentations/2021). About NyrstarThe Company is incorporated in Belgium and, following completion of the recapitalisation/restructuring has a 2% shareholding in the Nyrstar group. The Company is listed on Euronext Brussels under the symbol NYR. For further information please visit the Nyrstar website: www.nyrstar.be For further information contact: Anthony Simms - Head of External Affairs & Legal M: +41 79 722 2152 email@example.com Attachment FY 2020 Nyrstar results release EN
PRESS RELEASE Regulated Information 14 May 2021, 7:00am, Antwerp (Berchem), Belgium: VGP NV (‘VGP’ or ‘the Group’), a European provider of high-quality logistics and semi-industrial real estate, today published a trading update for the first four months of 2021: Continued strong operating performance €12.5 million signed and renewed lease agreements, bringing total annualized rental income to €196.8 million (+6% year-to-date)A record 1,041,000 m2 under construction representing €64.8 million in additional annual rent once fully built and let (currently 80.1% pre-let)Completed portfolio grown with 58k m2 to 2.50 million m2 which is 99.6% let Expansion of land bank to secure future growth Extended pipeline through 471,000 m2 of new land bought and a further 3.1 million m2 committed subject to permitsTotal land bank acquired and secured has grown to 8.54 million m2 (+11.6% year-to-date) which supports 4.0 million m2 of future lettable area Joint Venture closing anticipated for end of May with expected net cash proceeds of €52 million Advanced discussions with Allianz regarding expansion of first Joint Venture ongoing VGP’s Chief Executive Officer, Jan Van Geet, said: “The year 2021 has started on a strong footing as demand for premium locations remains at elevated levels due to changing consumer behaviour and technological advancements in industry. Year-to-date we have signed €12.5 million of lease agreements and we expect this number to grow in the coming weeks as several signed prelim agreements representing >€10 million are expected to be finalized.” Jan Van Geet continued: "As a result, our predominantly pre-let construction portfolio is topping for the first time 1 million m2, of which over half is situated in Germany (with 215k in VGP Park München) and the other projects well spread across the other European markets. These strong market fundamentals and our resilient delivery put us at pace for another very strong year.” Jan Van Geet concluded: “Our recent inaugural €600 million international green bond offering has allowed us to diversify our funding mix and provides enhanced flexibility for future capital allocation decisions. Whilst maintaining a disciplined and fortress balance sheet, we remain committed to using our resources to drive inclusive and sustainable solutions for the communities we serve as we support our customers in solving their logistics needs or manufacturing real estate requirements. This has enabled us, despite scarcity of permittable land, to continue to make significant investments in the future pipeline, by replenishing and growing our secured land bank with net 900,000 m2 year to date, including several trophy locations which will drive leasing growth in the coming years.” OPERATING HIGHLIGHTS – 4M 2021 Lease operations Signed and renewed rental income of € 12.5 million driven by €11.8 million of new leases (€2.6 million on behalf of the Joint Ventures1) and €0.7 million of renewals (all on behalf of the Joint Ventures). Lease agreements in the amount of € 0.2 million were terminatedAnnualized committed leases at April 2021 (including Joint Ventures at 100%) of €196.8 million (vs €185.2 million at Dec-20) of which €145.9 million related to the Joint VenturesSeveral leasing contracts are in the pipeline and expected to be signed in the coming weeksThe impact of COVID-19 on leasing operations and customer payment behaviour has been minimal with virtually all rent payments received on time Development activities Development of 39 projects under construction totalling 1,041,000 m2 of future lettable area and expected to generate € 64.8 million of new rent when fully built and leased (80.1% pre-let)Geographical split of parks under construction: 53% is located in Germany, 11% Spain, 7% in each Czech Republic and Slovakia, 5% Romania, 4% in each Italy and Netherlands, 3% in each Hungary and Portugal and 1% in AustriaDelivery of 4 projects during the first four months of 2021 of in total 58,000 m2 of lettable area representing € 1.2 million of annualized committed leases; these buildings are 100% letAll construction activities currently run on schedule whilst taking into account the applicable Health and Safety guidance and regulations for all our operations in relation to COVID-19 Land bank During the first four months of 2021 in total 0.47 million m2 of land was acquired representing a development potential of 0.20 million m2A further 3.09 million m2 of land plots are committed, pending permits, and have a development potential of 1.31 million m2 of future lettable area, bringing the total owned and secured land bank to 8.54 million m2 supporting 3.97 million m2 of future lettable areaIn addition 3.83 million m2 of land has been identified and is under exclusive negotiation (representing 1.58 million m2 of future lettable area) Renewable Energy A total solar power generation capacity of 48.8MWp is currently installed or under construction through 45 roof-projects. This is being realised through a €21 million investment to date. In addition, the pipeline identified at the moment equates to an additional power generation capacity of 64 MWp Capital and liquidity position On 31 March 2021, VGP announced the successful issue of a first benchmark international green bond for an aggregate nominal amount of € 600 million, paying a coupon of 1.50 per cent. p.a. and maturing on 8 April 2029. Demand exceeded 2.7 times the volume of the issue. The proceeds from this issuance are being used to fund the majority pre-let development pipeline, the build out of renewable energy assets and the design and development of new green logistics and semi-industrial parksBefore the end of May, we anticipate the eighth closing with VGP European Logistics, the First Joint Venture with Allianz Real Estate. The expected transaction value is €70 million and the expected net cash proceeds amount to €52 million. As the First Joint Venture has reached its expanded investment target, this will be the last closing with the First Joint Venture to include new parks.Advanced discussion with Allianz Real Estate with regards to the expansion of the First Joint Venture are progressing well and expected to be finalized in the coming weeksOn 14 May 2021, the Board of Directors will propose to the Annual Shareholders Meeting to distribute a gross dividend of €3.65 per share corresponding to a total gross dividend amount of €75.1 million, with payment date proposed for 25 May 2021 (to be confirmed by shareholders at the AGM) CONTACT DETAILS FOR INVESTORS AND MEDIA ENQUIRIES Martijn Vlutters (VP – Business Development & Investor Relations)Tel: +32 (0)3 289 1433Petra Vanclova (External Communications)Tel: +42 0 602 262 107Anette NachbarBrunswick GroupTel: +49 152 288 10363 FORWARD-LOOKING STATEMENTS This press release may contain forward-looking statements. Such statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. VGP is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release in light of new information, future events or otherwise. The information in this announcement does not constitute an offer to sell or an invitation to buy securities in VGP or an invitation or inducement to engage in any other investment activities. VGP disclaims any liability for statements made or published by third parties and does not undertake any obligation to correct inaccurate data, information, conclusions or opinions published by third parties in relation to this or any other press release issued by VGP. ABOUT VGP VGP is a pan-European developer, manager and owner of high-quality logistics and semi-industrial real estate. VGP operates a fully integrated business model with capabilities and longstanding expertise across the value chain. The company has a development land bank (owned or committed) of 8.54 million m² and the strategic focus is on the development of business parks. Founded in 1998 as a Belgian family-owned real estate developer in the Czech Republic, VGP with a staff of c. 300 employees today owns and operates assets in 11 European countries directly and through several 50:50 joint ventures. As of December 2020, the Gross Asset Value of VGP, including the joint ventures at 100%, amounted to € 3.84 billion and the company had a Net Asset Value (EPRA NAV) of € 1.35 billion. VGP is listed on Euronext Brussels and on the Prague Stock Exchange (ISIN: BE0003878957). For more information, please visit: http://www.vgpparks.eu 1 Joint Ventures means either and each of (i) the First Joint Venture i.e. VGP European Logistics S.à.r.l., the 50:50 joint venture between VGP and Allianz and (ii) the Second Joint Venture i.e. VGP European Logistics 2 S.à.r.l., the 50:50 joint venture between VGP and Allianz, and (iii) the Third Joint Venture i.e. VGP Park München GmbH, the 50:50 joint venture between VGP and Allianz, and (iv) LPM Joint Venture, i.e. LPM Holding B.V., the 50:50 joint venture between VGP and Roozen Landgoederen Beheer Attachment VGP - Trading update - 14 May 2021 (EN)
Geneva, Switzerland, May 14, 2021 – Addex Therapeutics (SIX: ADXN and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, announced today that its Annual General Meeting will take place on Wednesday 16 June 2021 at 11:00am CEST at the Campus Biotech, Chemin des Mines 9, 1202 Geneva. Due to the global coronavirus (COVID-19) outbreak, the Federal Council has enacted measures to prevent the spread of the coronavirus under the Ordinance on Measures to Combat the Coronavirus (COVID-19) (COVID-19 Ordinance 3). Among other measures, the Federal Council has banned all public and private events in Switzerland and allowed companies to impose on their shareholders the ability to exercise their rights exclusively through voting instructions to the Independent Voting Rights Representative. In accordance with the COVID-19 Ordinance 3, the Board of Directors ordered that all shareholders may exercise their rights at the Annual General Meeting (AGM) exclusively through the Independent Voting Rights Representative, Robert P. Briner, attorney-at-law, B & B Avocats. Shareholders will not be granted access to the meeting room on the day of the meeting. Agenda 1. Approval of the Annual Report, the Annual Financial Statements and the Consolidated Financial Statements for the business year 20202. Consultative vote on the Compensation Report for the business year 20203. Appropriation of the results4. Discharge of the members of the Board of Directors and of the Executive Management5. Re-elections of the members of the Board of Directors and re-election of the Chairman of the Board of Directors5.1. Re-election of Vincent Lawton as member and Chairman of the Board of Directors5.2. Re-election of Raymond Hill as member of the Board of Directors5.3. Re-election of Timothy Dyer as member of the Board of Directors5.4. Re-election of Roger Mills as member of the Board of Directors5.5. Re-election of Jake Nunn as member of the Board of Directors5.6. Re-election of Isaac Manke as member of the Board of Directors6. Re-elections of the members of the Compensation Committee6.7. Re-election of Vincent Lawton as member of the Compensation Committee6.8. Re-election of Raymond Hill as member of the Compensation Committee7. Re-election of the Auditors BDO AG8. Re-election of the Independent Voting Rights Representative9. Amendments to the Articles of Association9.9. Creation of an authorized share capital in an amount of CHF 24,636,476 and expiring on 16 June 2023 (article 3b of the Articles of Association)9.10. Increase of the conditional share capital by a total amount of CHF 8,212,159 from CHF 16,424,317 to CHF 24,636,476 (article 3c of the Articles of Association)10. Compensation of the members of the Board of Directors and of the Executive Management10.11. Compensation of the members of the Board of Directors10.12. Compensation of the members of the Executive Management11. MiscellaneousThe full invitation to the AGM 2021 may be found in the General Meetings section of the Company’s website here. About Addex Therapeutics:Addex Therapeutics is a clinical-stage pharmaceutical company focused on the development and commercialization of an emerging class of novel orally available small molecule drugs known as allosteric modulators for neurological disorders. Allosteric modulators offer several potential advantages over conventional non-allosteric molecules and may offer an improved therapeutic approach to conventional "orthosteric" small molecule or biological drugs. Addex’s allosteric modulator drug discovery platform targets receptors and other proteins that are recognized as essential for therapeutic intervention. Addex’s lead product candidate, dipraglurant (mGlu5 negative allosteric modulator or NAM), is poised to start a pivotal registration clinical trial for Parkinson’s disease levodopa induced dyskinesia (PD-LID) in Q2 2021. Addex is also investigating dipraglurant's therapeutic use in blepharospasm (a type of dystonia), for which a clinical trial is expected to be initiated in Q2 2021. Addex's third clinical program, ADX71149 (mGlu2 positive allosteric modulator or PAM), developed in collaboration with Janssen Pharmaceuticals, Inc., is scheduled to enter a phase 2a proof of concept clinical trial for the treatment of epilepsy in Q2 2021. Addex’s GABAB PAM program has been licensed to Indivior PLC, which is focused on development for the treatment of addiction. Preclinical programs include GABAB PAM for CMT1A, mGlu7 NAM for PTSD, mGlu2 NAM for mild neurocognitive disorders, mGlu4 PAM for Parkinson’s disease and mGlu3 PAM for neurodegenerative disorders. Addex shares are listed on the SIX Swiss Exchange and American Depositary Shares representing its shares are listed on the NASDAQ Capital Market, and trade under the ticker symbol "ADXN" on each exchange. Press Contacts: Tim DyerChief Executive OfficerTelephone: +41 22 884 15 55 PR@addextherapeutics.com Mike SinclairPartner, Halsin Partners+44 (0)20 7318 firstname.lastname@example.org James CarbonaraHayden IR+1 (646) 755 email@example.com Forward Looking Statements:This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including in respect of the anticipated initiation and progress of clinical trials and preclinical studies, and its future financing activities. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release, are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, uncertainties related to market conditions. These and other risks and uncertainties are described in the Company’s Annual Report on Form 20-F filed with the SEC on March 11, 2021, as well as market conditions and regulatory review. Any forward-looking statements contained in this press release represent Addex Therapeutics’ views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Addex Therapeutics explicitly disclaims any obligation to update any forward-looking statements, except as required by law.
If you need cash in Myanmar, you have to get up early. The cash crisis is one of the most pressing problems for the people of Myanmar after the Feb. 1 military coup. The central bank, now run by a junta appointee, has not returned some of the reserves it holds for private banks, without giving any reason, leaving the banks short of cash.
Japanese Marketing Authorization Application (J-MAA) for efgartigimod accepted for review by Japan’s Pharmaceuticals and Medical Device Agency (PMDA) for generalized myasthenia gravis (gMG) Management to host conference call today at 2:30 pm CEST (8:30 am ET) May 14, 2021Breda, the Netherlands – argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, today reported financial results for the first quarter 2021 and provided a business update. “We’ve had a strong start to 2021 with the acceptance for review of the BLA and J-MAA for efgartigimod in gMG by the regulatory agencies in the U.S. and Japan. The submissions in China and the EU are on track and we are well-positioned for a global launch of our first-in-class FcRn antagonist. We are building an exceptional team with significant launch experience in neurology and rare disease and hope to reach patients this year,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx. “Efgartigimod has the potential to help people living with gMG as well as several other severe autoimmune diseases mediated by IgG autoantibodies. Our team is advancing registrational trials across four indications with plans to start enrollment in two additional efgartigimod indications this year. We are also broadening our reach within autoimmunity with our first-in-class C2 inhibitor, ARGX-117, from which we will have Phase 1 data mid-year. To complement our clinical pipeline, we continue to invest in our discovery capabilities through our Immunology Innovation Program and strategic technology partnerships that position us well to generate long-term value for shareholders. We are closer each day to building an integrated, innovative, global immunology organization with the goal of impacting the lives of patients,” concluded Mr. Van Hauwermeiren. FIRST QUARTER 2021 AND RECENT BUSINESS UPDATE Commercial preparations on-track for global launch of IV efgartigimod for gMG, including regulatory submissions, initial salesforce hires and key stakeholder engagement efforts Biologics License Application (BLA) for IV efgartigimod for treatment of gMG accepted for review by U.S. Food and Drug Administration (FDA) with target action date of December 17, 2021 under Prescription Drug User Fee Act (PDUFA)J-MAA submitted to Japan’s PMDA and accepted for review with anticipated Japan commercial launch in 2022MAA expected to be filed with European Medicines Agency (EMA) in second half of 2021Zai Lab Limited to discuss potential accelerated regulatory pathway for approval in China with National Medical Products Administration (NMPA)Commercial readiness activities on-track, including: Continued build-out of global commercial organization, including hiring of U.S. regional business directors during first quarterLaunched pre-approval access (PAA) program in March 2021 in U.S., Canada and Europe to open availability of efgartigimod to people living with gMG who meet the pre-approval access program criteria Immunology pipeline advancing with five ongoing registrational trials of efgartigimod and initial upcoming data from second potential pipeline-in a product candidate, ARGX-117 Enrollment ongoing in five registrational trials across four indications, including ADAPT-SC (gMG), ADHERE (chronic inflammatory demyelinating polyneuropathy or CIDP), ADVANCE and ADVANCE-SC (primary immune thrombocytopenia or ITP), and ADDRESS (pemphigus) Go-forward decision confirmed in February 2021 in ADHERE trial evaluating subcutaneous (SC) efgartigimod in CIDP based on evaluation of interim safety and efficacy assessments that surpassed pre-defined thresholdEnrollment in trials for fifth and sixth indications to begin in 2021Additional efgartigimod indications to be evaluated as part of collaboration with Zai Lab Limited Data expected mid-year from Phase 1 trial of C2 inhibitor, ARGX-117; Phase 2 dosing plan to be identified for indications, including multifocal motor neuropathy (MMN) Phase 2 trial of MMN on track to start by end of 2021 Combination trials of cusatuzumab remain ongoing for treatment of acute myeloid leukemia (AML) as part of global collaboration and licensing agreement with Cilag GmbH International, an affiliate of Janssen Decision to initiate additional cusatuzumab studies under collaboration will be determined following review of all available data Immunology Innovation Program (IIP) continues to grow pipeline through wholly-owned development, partnered opportunities, asset-centric spinoff companies and the addition of strategic technology capabilities Preclinical work ongoing in early-stage pipeline, including ARGX-118, ARGX-119 and ARGX-12015-20 discovery programs under evaluation at any point in time that have emerged from IIPInitiated collaboration and license agreement with Elektrofi to explore new subcutaneous formulations for current and future pipeline candidates, including efgartigimod Secured exclusivity for FcRn and one additional target Ongoing development of ARGX-112 (LEO Pharma), ARGX-114 (AgomAb), ARGX-115 (ABBV-151, AbbVie) and ARGX-116 (Staten Biotech) by IIP collaboration partners Strong balance sheet and expanded Board of Directors support transition into integrated, global immunology organization Completed public offering of 3,593,750 ordinary shares in February 2021 with gross proceeds of $1.15 billionImplemented transition agreement for Chief Financial Officer Eric Castaldi as part of evolution to commercial-stage company; recruitment efforts ongoing for U.S.-based successorProposed resolutions presented during Annual General Meeting of Shareholders were approved, including: Appointment to Board of Directors of Yvonne Greenstreet, President and Chief Operating Officer of AlnylamRe-appointment of Anthony Rosenberg to Board of DirectorsApproval of new remuneration policy argenx to host virtual R&D Day on July 20, 2021 to share long-term corporate vision, disclose additional potential efgartigimod indications and provide updates across immunology pipeline. FIRST QUARTER 2021 FINANCIAL RESULTS (CONSOLIDATED) Three Months Ended March 31, (in thousands of $ except for shares and EPS) 2021 2020 VarianceRevenue $158,155 $21,139 $137,017Other operating income 9,260 4,672 4,588Total operating income 167,415 25,811 141,604 Research and development expenses (122,328) (104,661) (17,666)Selling, general and administrative expenses (56,253) (27,609) (28,644)Total operating expenses (178,580) (132,270) (46,310)Change in fair value on non-current financial assets 11,152 0 11,152Operating loss $(13) $(106,459) $106,446 Financial income/(expenses) (420) (3,591) 3,171Exchange gain/(losses) (28,817) 22,985 (51,802)Loss before taxes $(29,249) $(87,064) $57,815 Income taxes (11,184) (1,200) (9,984)Loss for the period and total comprehensive loss $(40,433) $(88,264) $47,831 Weighted average number of shares outstanding 49,946,515 42,786,194 Basic and diluted profit/(loss) per share (in $) (0.81) (2.06) Net increase/(decrease) in cash, cash equivalents and current financial assets compared to year-end 2020 and 2019 910,903 (70,318) Cash, cash equivalents and current financial assets at the end of the period 2,907,355 1,430,343 DETAILS OF THE FINANCIAL RESULTS As of January 1, 2021, the Company changed its functional and presentation currency from euro to U.S. dollars, which results in reporting its financial highlights in U.S. dollar as compared to euro in prior periods. Historical financials have been converted at the average exchange rate of the related period. Cash, cash equivalents and current financial assets totaled $2,907.4 million on March 31, 2021, compared to $1,996.5 million on December 31, 2020. The increase in cash, cash equivalents and current financial assets resulted primarily from (i) the closing of a global offering, which resulted in the receipt of $1,092.1 million in net proceeds in February 2021, (ii) the net receipt of a $73.1 million non-creditable, non-refundable development cost-sharing payment in the form of newly issued Zai Lab shares received as part of the strategic collaboration for efgartigimod in Greater China, partially offset by (iii) the payment of $98.0 million related to the purchase of a priority review voucher from Bayer HealthCare Pharmaceuticals and other net cash flows used in operating activities. Total operating income increased by $141.6 million for the three months ended March 31, 2021 to $167.4 million, compared to $25.8 million for the three months ended March 31, 2020. The increase was primarily due to the closing of the strategic collaboration for efgartigimod with Zai Lab, resulting in the recognition of $151.9 million in collaboration revenue. Research and development expenses increased by $17.7 million for the three months ended March 31, 2021 to $122.3 million, compared to $104.7 million for the three months ended March 31, 2020. The increase in the first three months of 2021 resulted primarily from higher external research and development expenses, mainly related to the efgartigimod program in multiple indications and other clinical and preclinical programs. Furthermore, the research and development personnel expenses increased due to a planned increase in headcount and the increased costs of the share-based payment compensation plans related to the grant of stock options. Selling, general and administrative expenses totaled $56.3 million for the three months ended March 31, 2021, compared to $27.6 million for the three months ended March 31, 2020. The increase resulted primarily from higher personnel expenses, including the costs of the share-based payment compensation plans related to the grant of stock options, and consulting fees linked to the preparation of a possible future commercialization of efgartigimod. The increase in fair value on non-current financial assets amounted to $11.2 million for the three months ended March 31, 2021, which is the result of the closing of a Series B financing round of AgomAb Therapeutics, for which the Company maintains a profit share in exchange for granting the license for the use of HGF-mimetic antibodies from the SIMPLE Antibody™ platform. Exchange losses totaled $28.8 million for the three months ended March 31, 2021, compared to an exchange gain of $23.0 million for the three months ended March 31, 2020. As a result of the change in the Company’s functional and presentation currency, the exchange losses for the three months ended March 31, 2021 are reflecting the unfavorable change in euro/U.S. dollar exchange rate, mainly attributable to unrealized exchange rate losses on cash, cash equivalents and current financial asset position in euro. FINANCIAL GUIDANCE Based on current plans to fund anticipated operating expenses and capital expenditures, argenx continues to expect its 2021 cash burn to approximately double from 2020. The increased spend will support the Company’s transition to an integrated immunology company, including the build-out of global commercial infrastructure and drug product inventory ahead of the expected launch of efgartigimod in gMG in the U.S, the advancement of its clinical-stage pipeline, including seven expected global trials of efgartigimod, and the continued investment in its Immunology Innovation Program. EXPECTED 2021 FINANCIAL CALENDAR July 29, 2021: HY 2021 financial results and business updateOctober 28, 2021: Q3 2021 financial results and business update CONFERENCE CALL DETAILSThe first quarter 2021 financial results and business update will be discussed during a conference call and webcast presentation today at 2:30 pm CEST/8:30 am ET. A webcast of the live call may be accessed on the Investors section of the argenx website at argenx.com/investors. A replay of the webcast will be available on the argenx website. Dial-in numbers:Please dial in 15 minutes prior to the live call. Belgium 0800 389 13 France 0805 102 319 Netherlands 0800 949 4506 United Kingdom 0800 279 9489 United States 1 844 808 7140International 1 412 902 0128 About argenxargenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx is evaluating efgartigimod in multiple serious autoimmune diseases, and cusatuzumab in hematological cancers in collaboration with Janssen. argenx is also advancing several earlier stage experimental medicines within its therapeutic franchises. argenx has offices in Belgium, the United States, Japan, and Switzerland. For more information, visit www.argenx.com and follow us on LinkedIn at https://www.linkedin.com/company/argenx/ and Twitter at https://twitter.com/argenxglobal. For further information, please contact: Media:Kelsey KirkKKirk@argenx.com Joke Comijn (EU)firstname.lastname@example.org Investors:Beth DelGiaccobdelgiacco@argenx.com Michelle Greenblattmgreenblatt@argenx.com Forward-looking Statements The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements.” These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “believes,” “estimates,” “anticipates,” “expects,” “intends,” “may,” “will,” or “should” and include statements argenx makes concerning its statement that the submissions in China and the EU are on track and that it is well-positioned for a global launch of its first-in-class FcRn antagonist, including that BLA for IV efgartigimod for treatment of gMG accepted for review by the U.S. Food and Drug Administration (FDA) in March 2021 with target action date of December 17, 2021 under Prescription Drug User Fee Act (PDUFA), J-MAA submitted to Japan’s PMDA and accepted for review with anticipated Japan commercial launch in 2022, MAA expected to be filed with European Medicines Agency (EMA) in second half of 2021 and Zai Lab Limited to discuss potential accelerated regulatory pathway for approval in China with National Medical Products Administration (NMPA); statements regarding its commercial readiness; its statement that enrollment in trials for fifth and sixth indications to begin in 2021; its statement that data expected mid-year from Phase 1 trial of C2 inhibitor, ARGX-117; Phase 2 dosing plan to be identified for indications including multifocal motor neuropathy (MMN), and Phase 2 trial of MMN on track to start by end of 2021; its expectation that its 2021 cash burn will approximately double from 2020; its hope to reach patients this year; its statements regarding the therapeutic potential of Efgartigimod in patients with gMG as well as several other severe autoimmune diseases mediated by IgG autoantibodies; its plans to start enrollment in two additional efgartigimod indications this year, its expectation to have Phase 1 data mid-year for its C2 inhibitor, ARGX-117, 2021 business and financial outlook and related plans; the therapeutic potential of its product candidates; the intended results of its strategy and argenx’s, and its collaboration partners’, advancement of, and anticipated clinical development, data readouts and regulatory milestones and plans, including the timing of planned clinical trials and expected data readouts; the design of future clinical trials and the timing and outcome of regulatory filings and regulatory approvals. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including the effects of the COVID-19 pandemic, argenx’s expectations regarding its the inherent uncertainties associated with competitive developments, preclinical and clinical trial and product development activities and regulatory approval requirements; argenx’s reliance on collaborations with third parties; estimating the commercial potential of argenx’s product candidates; argenx’s ability to obtain and maintain protection of intellectual property for its technologies and drugs; argenx’s limited operating history; and argenx’s ability to obtain additional funding for operations and to complete the development and commercialization of its product candidates. A further list and description of these risks, uncertainties and other risks can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’s most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law.
The Aurora Cultural Centre may not be able to welcome residents into the Church Street School due to Library Square construction, or into their temporary gallery space at Town Hall due to the global pandemic, but curators are ready to bring the arts to you. This Tuesday, May 18, the Aurora Cultural Centre (ACC) will launch a new Arts Talk series, featuring various topics of interest, all tied together by the arts. The first topic will be Arts Education & Mental Health, with subsequent events including Building Arts Programs for our Community on June 18, Addressing Questions on Diversity & Inclusion in the Arts on July 20, and How Are They Doing? Checking In with Artists as We Emerge from the Pandemic on August 17. Arts Education & Children’s Mental Health will feature panellists Tania Marie DeSilva, Clinical Director, Behaviour Matters; Marji Chud, Professor and lead at Young People’s Theatre; Patty Jarvi, Professor and Program Manager for Listen Up!; and in the role of moderator, George Vellathottam of the York Region District School Board. “The effects of arts education on a child’s mental health is vital at the best of times,” says the ACC. “Over the past year, in-school arts programs have either been drastically scaled back or temporarily eliminated due to health and safety guidelines. Join [us] to discover the benefits of arts education to a child’s mental health and sense of community-building, how they view the challenges of the past year, and the way forward as we re-engage children in the arts.” Adds Suzanne Haines, Executive Director of the ACC: “Arts Talk is a new initiative for the Aurora Cultural Centre to engage in conversation with our community on relevant arts topics. Over the next four months, we will welcome expert panelists opening new doors to shared learning in the arts. The first event is on May 18 at 7 p.m. We are inviting the community to join us at the panel discussion to hear about how the arts affect a child’s mental health, what impact this past year in children’s mental health given the pandemic and the change in programming, the benefits of arts education, and opinions on what more we can all do to support arts activities in schools.” To register for the free Arts Talk series, visit auroraculturalcentre.ca/arts-talk. Brock Weir, Local Journalism Initiative Reporter, The Auroran
SEATTLE (AP) — Zach Plesac came within six outs of ending Cleveland’s 40-year no-hitter drought, keeping the Seattle Mariners hitless into the eighth inning of the Indians’ 4-2 win on Thursday night. The anticipated debuts of Seattle prospects Jarred Kelenic and Logan Gilbert were overshadowed by a masterful pitching performance by Plesac. His bid for Cleveland’s first no-no since 1981 ended when J.P. Crawford led off the eighth inning with a line-drive single that just cleared the glove of leaping shortstop Amed Rosario. Plesac (3-3) lost the shutout moments later when Dylan Moore hit a two-run homer. That sent the Indians’ bullpen into a frenzy to get ready. Moore’s shot was his fourth of the season and one of the few hard-hit balls all night against Plesac. While he wasn’t overpowering, Plesac managed to induce weak contact for most of the first seven innings. The right-hander escaped the eighth after a lineout from Evan White and Kelenic’s deep flyout to left-center. He finished with two strikeouts and three walks on 96 pitches. Emmanuel Clase walked three straight batters with two outs in the ninth to load the bases. Cleveland manager Terry Francona brought in Bryan Shaw, who struck out Luis Torrens for his first save. Cleveland has the longest no-hitter drought in the majors — its last one was Len Barker’s perfect game in 1981. Plesac got all the offense he needed on home runs from Frammil Reyes and José Ramírez. Reyes hit his ninth of the season in the second inning and Ramírez added his AL-leading 11th in the third inning, a two-run shot. Jake Bauers also had an RBI single. For much of the night, it appeared Seattle would join infamy by getting no-hit in consecutive home games. Baltimore’s John Means stymied the Mariners on May 5, barely missing out a perfect game against Seattle. The Mariners left on a road trip but their hitting woes at home remained. Seattle went 16 innings at home without a hit before Crawford’s single. Gilbert (0-1) lasted four innings, throwing 71 pitches and struck out five. Seattle was going to limit Gilbert to around 85 pitches and was hoping to get him into the fifth. The 24-year-old right-hander threw plenty of strikes and flashed a good mix of breaking pitches to go with his fastball. Kelenic was hitless in four at-bats. He lined out on the first pitch of his first at-bat in foul territory, with right fielder Josh Naylor falling into the stands as he caught the ball. UNMASKED MAN The Indians have 85% of their club vaccinated, which has allowed them to ease up on some of MLB’s COVID-19 protocols. It might take some getting used to. “They’ve relaxed some things that guys are allowed to do and we’re allowed to do in the dugout,” Francona said. “There’s still protocols when you’re in the clubhouse or at the hotel. There’s things you still have to follow. But it felt good to be in the dugout and not have a mask on. It felt like kind of naked, like you had your zipper down or something because it was so different.” UP NEXT Indians: Aaron Civale (5-0, 2.91) looks to remain unbeaten on the season. Civale has thrown at least seven innings in four of his seven starts, including his last against Cincinnati when he allowed only one run. Mariners: RHP Chris Flexen (3-1, 3.78) makes his seventh start. Flexen earned his third victory in his last start against Texas throwing 6 1/3 innings and allowing four runs. ___ More AP MLB: https://apnews.com/hub/MLB and https://twitter.com/AP_Sports Tim Booth, The Associated Press
PHOENIX (AP) — Devin Booker made two free throws with 2.4 seconds remaining to give the Phoenix Suns a 118-117 victory over the Portland Trail Blazers on Thursday night. Booker’s winning foul shots were set up when Portland's Robert Covington was fouled and missed both free throws with 4.4 seconds left, giving the Suns one last chance. Booker was fouled by Norman Powell as he went up for a jumper with 2.4 seconds remaining, and Portland's C.J. McCollum missed a 3-point shot at the buzzer to seal Phoenix’s win. With the victory, Phoenix moved within a game of Utah for the No. 1 seed in the Western Conference with two games to play. Chris Paul led Phoenix with 26 points on 11-of-14 shooting. Mikal Bridges chipped in with 21 points and 11 rebounds, and Booker had 18 points but shot just 5 of 17 from the field. Damian Lillard scored a game-high 41 points on 16-of-23 shooting for Portland, which had its five-game winning streak stopped. McCollum had 27 points. The Trail Blazers, who were playing the second of a back-to-back after beating Utah on Wednesday night, dropped into the No. 6 seed in the Western Conference, a half-game back of Dallas with two games to play. The Suns, who had lost three of four coming in, avoided their first three-game skid of the season. Phoenix played without center Deandre Ayton, who missed his first game of the season with a sore left knee. Suns coach Monty Williams declined to provide any details about Ayton’s injury before the game, saying only that he “came in sore today. The Suns started Dario Saric in Ayton’s place. The Suns turned what had been a tight game into an 85-77 lead heading into the fourth quarter, thanks to reserve forward Torrey Craig, who scored 10 points in the final 2:07 of the third quarter. Craig hit back-to-back 3-pointers to spark the run. Backup point guard Cam Payne scored 21 points for the Suns, including 11 in the third quarter. Portland and Phoenix couldn’t get any separation in the first half; there were 16 lead changes and the biggest lead was four points by each team. TIP-INS Blazers: Forward Nassir Little was out with back spasms. ... McCollum and Lillard combined for 35 points and eight assists in the first half. Suns: In addition to Ayton not being available, Phoenix was without forwards Cam Johnson (wrist) and Abdel Nader (knee). ... The Suns need one win to reach the 50-win mark for the first time since the 2009-2010 season. UP NEXT Blazers: Return home to host the Nuggets on Sunday Suns: Travel to face the Spurs on Saturday and Sunday to close the regular season. ___ More AP NBA coverage: https://apnews.com/hub/NBA and https://twitter.com/AP_Sports Scott Bordow, The Associated Press
The number of recorded COVID-19 infections in India climbed above 24 million on Friday amid reports that the highly transmissible coronavirus mutant first detected in the country was spreading across the globe. The Indian B.1.617 variant of the virus has been found in cases in eight countries of the Americas, including Canada and the United States, said Jairo Mendez, a WHO infectious diseases expert. People infected by the variant included travellers in Panama and Argentina who had arrived from India or Europe.
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