Boris Sofman, Director Of Engineering & Head of Trucking at Waymo, explains the difficulties that startups will face entering the autonomous trucking space.
Boris Sofman, Director Of Engineering & Head of Trucking at Waymo, explains the difficulties that startups will face entering the autonomous trucking space.
Moderna Inc Chief Executive Officer Stéphane Bancel expects interim results from its COVID-19 vaccine trial in November and that the U.S government could give an emergency use nod in December, the Wall Street Journal reported https://www.wsj.com/articles/moderna-ceo-expects-covid-19-vaccine-interim-results-in-november-11603164001?mod=searchresults&page=1&pos=1 on Monday. Speaking at the newspaper's annual Tech Live conference, Bancel also said sufficient interim results from the study takes longer to get and that the government's permission to use the vaccine may not come until next year. The first interim analysis of the vaccine's efficacy will happen when 53 people in the entire study get symptomatic COVID-19, the report said.
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In Q3 of 2020, AS LHV Group earned EUR 10.8 million in consolidated net profit. AS LHV Pank earned EUR 10.7 million in net profit, at that, EUR 1.2 million in net profit from servicing clients related to the United Kingdom branch. AS LHV Varahaldus earned EUR 0.8 million in net profit.Compared to Q2 of this year, the net profit of the consolidation group grew by EUR 7.2 million, i.e., it tripled. Compared to Q3 of 2019, net profit grew by EUR 2.8 million, i.e. 35%. The Group’s return on equity was 18.9%. Previously formed discounts on loans were partially reduced.In Q3, LHV Group’s volume of assets increased to EUR 4.1 billion, i.e. by 10%. Within the quarter, the Group’s consolidated loan portfolio grew by EUR 52 million to EUR 1.86 billion (+3%; + EUR 65 million in Q2) and consolidated deposits increased by EUR 129 million to EUR 3.22 billion (+4%; + EUR 134 million in Q2). At the same time, deposits related to payment institutions increased by EUR 57 million, while deposits related to deposit platforms decreased by EUR 137 million. The total volume of funds managed by LHV increased by EUR 56 million in Q3, to EUR 1.5 billion (+4%; + EUR 96 million in Q2).Within the quarter, LHV added more than 11,000 bank clients, with the bank’s total number of clients surpassing 235,000. The number of active clients of the II pension pillar increased by more than 4000 in the quarter.In Q3, all pension funds managed by LHV Varahaldus had a positive rate of return; at that, funds with a higher equity risk showed the best rate of return. In Q3, the best rate of return was provided by LHV Pension Fund Roheline, its rate of return for the three months being 20.4%.AS LHV Group’s consolidated net profit in the first 9 months of 2020 was EUR 21.8 million, which is EUR 1.1 million higher than the result of the first 9 months of 2019. AS LHV Pank earned EUR 21.6 million and AS LHV Varahaldus EUR 1.3 million as net profit in 9 months. Since, in terms of consolidated profit, LHV is ahead of the current financial plan by EUR 8.3 million, the company will publish an updated financial plan in October 2020.Comment by Madis Toomsalu, Managing Director of the LHV Group: "For LHV, the third quarter was active and effective. We have continued with an open credit policy and with activities directed at the future. Our credit portfolio remains high quality. Our clients have used the grace periods granted largely as a precaution for ensuring liquidity. September was a great example of this: in relation to grace periods, of the loans in the amount of EUR 54 million that were supposed to end, payments in the extent of only EUR 6 million were postponed. The EUR 52 million growth of our loan portfolio was characterised by an decline in demand, rather than supply.However, looking at the volume of billions of euros that are proposed as a political response to the estimated economic downturn, Estonian companies should prepare for the next economic upturn. The real world is indeed more complicated, since an economic downturn will lead to a decrease in investments with a leveraged effect; also, in order to benefit, different subsidies and loans received must be placed in a yielding manner. Still, considering the political measures and the measures of central banks, a considerable amount of funds will reach the real economy through money markets. Whether this is all good or reasonable should be left for discussions of economic theory, but in case of today’s investment decisions, mathematics should not be ignored. In the short term, the main virtue is still liquidity, and such a recommendation for making investments is directed at companies with a sufficient cash balance or good access to financing. Likewise, it is important to carefully contemplate the sustainability of such investments as well as their suitability for the future.Among the more important events, the international business magazine Euromoney picked LHV as the best bank in Estonia for the third year in a row. In August, we were the first bank to introduce a virtual ISIC card intended for students, we added the contactless payment opportunity for users of Fitbit and Garmin devices, and we introduced a home credit card together with Alexela. From September, we started providing full service payment acquiring, which is a simple and beneficial opportunity for merchants to offer their clients the payment methods they require.In September, we finished the public offering of LHV’s subordinated bonds. Since the initial issue volume of EUR 25 million was oversubscribed by 3.4 times, we increased the issue volume within the maximum permitted volume, to EUR 35 million.After the quarter, at the beginning of October, we finalised the transaction in the course of which we acquired Danske’s credit portfolio related to Estonian companies, apartment associations and the public sector. The final volume of the transaction worked out to EUR 273 million. As a result of the transaction, LHV Pank’s loan portfolio grew by EUR 254 million, and surpassed the EUR 2 billion line for the first time.We are still applying for an activity licence for the non-life insurance undertaking LHV Kindlustus. We hope to receive the activity licence from the Financial Supervision Authority around the turn of the year. At the same time, we are engaged in preparing information systems, recruiting people, and preparing the introduction of products to the market.In terms of profit, we are ahead of the current financial plan published in April by EUR 8.3 million. The estimated crisis has been easier than forecast before, and the granted grace periods gave our clients the opportunity to build the necessary reserves. This is why the formed provisions have been EUR 6.4 million lower than planned. For this reason, we will be updating LHV Group’s financial plan for the current year in October."Income statement, EUR thousand Q3-2020 Q2-2020 9 months 2020 9 months 2019 Net interest income 16 731 15 545 48 599 34 119 Net fee and commission income 6 472 6 188 19 168 19 250 Net gains from financial assets 335 322 268 500 Other income 44 -16 64 26 Total revenue 23 582 22 039 68 098 53 895 Staff costs -5 630 -6 146 -17 546 -14 029 Office rent and expenses -45 -236 -559 -682 IT expenses -868 -782 -2 379 -1 909 Marketing expenses -557 -315 -1 347 -1 646 Other operating expenses -3 613 -3 183 -10 717 -9 641 Total operating expenses -10 713 -10 661 -32 548 -27 908 EBIT 12 869 11 378 35 550 25 987 Earnings before impairment losses 12 869 11 378 35 550 25 987 Impairment losses on loans and advances 27 -7 672 -8 655 -1 663 Income tax -2 122 -156 -5 086 -3 664 Net profit 10 774 3 550 21 808 20 660 Profit attributable to non-controlling interest 677 615 1 697 1 583 Profit attributable to share holders of the parent 10 096 2 935 20 111 19 078 Balance sheet, EUR thousand Sept 2020 Jun 2020 Sept 2019 Cash and cash equivalents 1 753 730 1 438 793 1 468 510 Financial assets 430 661 423 117 124 035 Loans granted 1 870 335 1 818 644 1 233 626 Loan impairments -14 512 -14 608 -11 561 Receivables from customers 2 443 3 039 33 491 Other assets 29 216 28 527 28 700 Total assets 4 071 872 3 697 512 2 374 714 Demand deposits 2 756 352 2 512 196 2 005 227 Term deposits 459 132 574 739 529 442 Loans received 471 554 271 553 28 640 Loans received and deposits from customers 3 687 038 3 358 488 2 563 309 Other liabilities 35 252 35 702 39 524 Subordinated loans 125 000 90 000 75 000 Total liabilities 3 847 290 3 484 190 2 677 833 Equity 224 582 213 322 198 967 Minority interest 5 921 5 243 4 505 Total liabilities and equity 4 071 872 3 697 512 2 374 714 AS LHV Group reports are available at https://investor.lhv.ee/en/reports. In order to introduce the quarterly results, LHV Group will be organising an investor meeting which will be conducted in the webinar form through the Zoom environment. The virtual investor meeting will take place on 20 October at 18:00. The presentation will be in Estonian. You can register at https://lhvbank.zoom.us/meeting/register/tJAvcOqrrTMqG9HWPYShAMC3PcuZAXYksDS2.LHV Group is the largest domestic financial group and capital provider in Estonia. LHV Group's key subsidiaries are LHV Pank and LHV Varahaldus. LHV employs over 490 people. LHV’s banking services are used by more than 235,000 clients, and pension funds managed by LHV have more than 183,000 active clients. LHV’s UK branch offers banking infrastructure to 130 international financial services companies, via which LHV’s payment services reach clients around the world. Priit Rum Communication Manager Phone: +372 502 0786 Email: email@example.com Attachments * LHV Group Factbook 2020-Q3-EN * LHV Group Interim Report 2020-Q3-EN * LHV Group Presentation 2020-Q3-EN
Amazon announces a season of giving, donating millions of items through product and monetary donations to over a thousand charities around the world.
Idavang A/S is considering issuing new senior secured bonds in connection with a potential early redemption of current senior secured bonds maturing in December 2021 To refinance Idavang A/S' (“Idavang” or “The Company”) current senior secured bonds of EUR 85 million maturing in December 2021, Idavang has mandated Pareto Securities to arrange a series of investor meetings with the aim of investigating the possibility of issuing new senior secured bonds. An issue of a senior secured bond loan denominated in euros may follow, subject to prevailing market conditions.In connection with the above-mentioned investor meetings, the Company will present material that includes selected operational information that has not previously been communicated to the market, this information is also disclosed through announcement of the Company’s interim report for Q3 2020, which is available from the Company’s website (https://www.idavang.com/investors). Further informationBondholders - Claus Baltsersen, CEO phone +370 (685) 34 104Attachment * Company announcement no 23 2020 Idavang AS is considering issuing new senior secured bonds
EBITDA fixed herd prices (FHP) for Q3 2020 decreased to 7,253 mEUR (Q3 2019: 9,052 kEUR), corresponding to an EBITDA margin FHP of 29.3% (Q3 2019: 31.0%). Q3 harvest influenced EBITDA margin significantly, as it is EBITDA without revenue. Harvest EBITDA was Q3 2020 3.8 mEUR and Q3 2019 3.8 mEUR, EBITDA margin FHP (without harvest) was 14.1% (Q3 2019: 18.0%).Sales prices in Q3 were 1.12 EUR/kg live weight down from 1,14 EUR/kg (Q2 2020). The price decrease from Q2 has been driven by a Corona impact on the supply chain and effect from ASF outbreak in Germany, partly compensated with that Russian prices have rebounded somewhat due to season and increasing export from Russia to Vietnam. The outlook is highly uncertain with the ASF situation in China/Germany and a potential rebound of Coronavirus impacting supply chains. Feed prices in Q3 were 229 EUR/T as in Q2 2020 (compared to 244 EUR/T Q3 2019). A significant amount of grain is hedged until harvest 2021 either in storage or contract, reducing feed price fluctuations. The herd valuation in Q3 decreased by 3,821 mEUR (compared to 30.06.2020). Lower prices drove the decrease in EU and Lithuania, partly compensated by Russia. Free cash flow was 3,771 kEUR in Q3 2020 (Q3 2019: 2.294 kEUR). Net interest-bearing debt has last quarter decreased from 68,3 mEUR to 64,0 mEUR driven by operational cashflow Q3 (3,1 mEUR) and devaluating in Q3 (2,4 mEUR).Idavang expects IFC put option being called during November month. Further informationBondholders - Claus Baltsersen, CEO phone +370 (685) 34 104Media - Jytte Rosenmaj, Board Member phone +45 26 73 46 99Attachment * Company announcement no 22 2020 Q3 2020 Idavang Interim Report
Operational The fleet utilisation rate in the third quarter of 2020 was 16.4 per cent (Q3 2019: 48.2 per cent). Prosafe has been in discussions with several clients about existing contracts in light of Covid-19 and the oil price collapse, and has managed to protect its order book by moving contracts from 2020 to 2021 with some further extensions. Please see the update per vessel below. Prosafe continues to claim full contract value from EnQuest relating to the planned Thistle project for the Safe Zephyrus. Prosafe has agreed with Shell to defer and amend the contract for the Safe Zephyrus at the Shearwater platform. The revised firm duration of the contract is 115 days and the contract is scheduled to commence in March 2021. Shell has the option of adding 30 or 45 days to the front end, resulting in a possible earlier commencement date. In addition, Shell retains the option to extend the contract after the firm duration by up to 30 days. The Safe Zephyrus is currently laid up at Averøy yard in Norway preparing to conduct her five-yearly special periodic survey. Safe Caledonia is currently laid up in the UK. The vessel is scheduled to commence a 162-day contract with a 30-day option for Total at Elgin in the UK from Q1 2021. This contract was originally scheduled to commence in 2020. Safe Eurus has been providing safety and maintenance support to Petrobras during a three-year contract since November 2019. From April 2020, the Safe Eurus was suspended for 120 days at zero rate. The vessel has been on standby rate since early August and recommenced operations on 24 September 2020. The original three-year and 222-day firm contract for the Safe Notos that was due to complete in July 2020 was suspended for 120 days at zero rate from April 2020. The vessel was back on standby rate in early August 2020 and resumed operations in early October 2020. Safe Concordia was idle in the quarter and is laid up in Brazil. Safe Scandinavia, Safe Boreas and Regalia were idle in the quarter and are laid up in Norway. Regalia has been marketed for recycling with possible commencement of recycling in Q1 2021. Although the impact from Covid-19 on the macro environment has been challenging, the company has successfully implemented proper safety measurements at workplaces and vessels to protect people and assets, as well as several cost-saving initiatives to protect liquidity. Financial Please refer to separate press release from 1 October 2020 regarding the ongoing discussion with lenders about a long-term financial solution for the company. Prosafe is a leading owner and operator of semi-submersible accommodation vessels. The company is listed on the Oslo Stock Exchange with ticker code PRS. For more information, please refer to https://www.prosafe.com Stavanger, 20 October 2020 Prosafe SE For further information, please contact: Jesper K. Andresen, CEO Phone: +47 51 65 24 30 / +47 907 65 155 Stig Harry Christiansen, Deputy CEO and CFO Phone: +47 51 64 25 17 / +47 478 07 813 This information is subject to the disclosure requirements pursuant to Section 5-12 the Norwegian Securities Trading Act
EUR 110 million investment will increase capsule production by +60% Press release Amsterdam, 20 October 2020 JDE Peet’s (EURONEXT: JDEP), the world's largest pure-play coffee and tea group by revenue, today announced plans to invest EUR 110 million in its global supply network through the installation of new high-speed aluminium coffee capsule production lines. These additional lines will be installed in stages over the coming 18 months beginning with new lines in Andrézieux, France that will become operational in the course of H1 2021. These investments are the latest in a series of manufacturing capacity expansions designed to meet the increased consumer demand for single serve products. The total EUR 110 million investment will increase JDE Peet’s capsule production capacity by +60% to meet the rapidly expanding consumer demand for premium Single Serve coffee experiences.“The total Single Serve coffee category has seen tremendous growth, a trend that is expected to continue, with aluminium coffee capsules serving as a strong driver,” said Fabien Simon, CEO of JDE Peet’s. “We were the first to bring aluminium coffee capsules into grocery stores back in 2016, driving general category growth, increasing consumer choice and creating value for our customers. This new strategic investment ensures that JDE Peet’s is well positioned within the market as this category continues to expand.” Since pioneering the aluminium coffee capsule market in grocery retail back in 2016, JDE Peet’s has quickly gained significant market share in one of the fastest growing premium coffee segments and has successfully applied this technology throughout its brand portfolio in 47 markets. According to Euromonitor, JDE Peet’s represents ~13% of the total Single Serve coffee category, which is currently valued at EUR 17 billion and is expected to grow at an annual rate of 7.8% to EUR 23 billion by 2024, fuelled by consumers’ increasing preference for premium Single Serve coffee products. Since the introduction of aluminium coffee capsules in 2016, the Andrézieux factory has become a major employer in the Auvergne-Rhône-Alpes region, growing its workforce by more than 60% (150 jobs). The factory produces more than 400 different types of coffee and recently celebrated the production of its 10 billionth aluminium coffee capsule.Enquiries Media Michael Orr (EN) | Nathalie Rolland (FR) Media@JDEPeets.comInvestors & Analysts Robin Jansen +31 6 1594 4569 Robin.Jansen@JDEcoffee.com About JDE Peet’s JDE Peet’s is the world's largest pure-play coffee and tea group by revenue, serving approximately 130 billion cups of coffee and tea in the financial year ended 31 December 2019 in more than 100 developed and emerging countries. With a portfolio of more than 50 leading global, regional and local coffee and tea brands, JDE Peet’s offers an extensive range of high-quality and innovative coffee and tea products and solutions to serve consumer needs across markets, consumer preferences and price levels. In 2019, JDE Peet’s generated total sales of EUR 6.9 billion and had on average 21,255 employees worldwide. The JDE Peet’s global portfolio includes: Jacobs, Peet’s, L’OR, Senseo, Tassimo and Ti Ora. For more information please visit JDE Peet’s website.Attachment * 201020 JDE Peets to significantly expand its aluminium coffee capsule production capacity
* Vifor Pharma secures commercial rights for IV Korsuva in non-Fresenius Medical Care dialysis clinics representing approx. 66% of the market, under a profit-sharing arrangement with Cara * Cara will receive a USD 100 million upfront payment and an equity investment of USD 50 million * IV Korsuva aims to address a significant unmet medical need for a highly debilitating disease * NDA submission for IV Korsuva expected in Q4, 2020\- Cara to Host Conference Call Today at 8:30 am EDT -STAMFORD, Conn. and ST. GALLEN, Switzerland, Oct. 20, 2020 (GLOBE NEWSWIRE) -- Vifor Pharma and Cara Therapeutics, Inc. (Nasdaq:CARA) today announced that both companies have signed a license agreement for commercialization of Korsuva (difelikefalin) Injection (“IV Korsuva”) for the treatment of chronic kidney disease-associated pruritus (CKD-aP) in the US dialysis market for non-Fresenius Medical Care clinics under a Cara 60%, Vifor Pharma 40% profit-sharing arrangement.“With an established fully dedicated nephrology sales force in the US, Vifor Pharma is an ideal commercialization partner to bring IV Korsuva to dialysis patients across the country,” said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. “In addition, we believe Vifor Pharma’s existing relationships with US dialysis providers will provide significant momentum for the launch and adoption of IV Korsuva, if approved. As a result of this agreement, we expect to focus Cara’s internal resources on our clinical programs for Oral Korsuva in atopic dermatitis, pre-dialysis CKD and additional pruritic conditions.”“Vifor Pharma has a strong market position and deep expertise in the nephrology space. This agreement further strengthens our US nephrology presence. The Vifor Pharma Group now has the commercialization rights for IV Korsuva in the full dialysis segment by adding all non-FMC dialysis clinics, representing approximately 66% of the US market,” said Stefan Schulze, CEO of Vifor Pharma Group. "Moderate to severe haemodialysis-associated pruritus is a debilitating condition that impacts up to 40% of dialysis patients around the world and for which there is currently no approved treatment in the US or Europe. IV Korsuva is an important, innovative new therapeutic that has the potential to address this significant unmet need. We remain committed to making IV Korsuva available next year to dialysis patients, who urgently need an effective therapy.”Under the terms of the agreement, Cara will receive an upfront payment of USD 100 million in cash and an equity investment of USD 50 million. In addition, Cara will be eligible to receive an additional equity investment upon US regulatory approval of IV Korsuva, as well as milestone payments dependent on achieving commercial targets, which together could total up to USD 290 million. Additional information regarding the terms of the agreements between Cara and Vifor announced today will be set forth in a Current Report on Form 8-K to be filed by Cara with the U.S. Securities and Exchange Commission on October 20, 2020.In May 2018, Cara Therapeutics and Vifor Fresenius Medical Care Renal Pharma (VFMCRP) signed an initial agreement that granted the rights to develop and commercialize IV Korsuva for the treatment of chronic kidney disease-associated pruritus (CKD-aP) in hemodialysis and peritoneal dialysis patients worldwide, excluding the US, Japan and South Korea. At that time Cara retained full development and commercialization rights for IV Korsuva for the treatment of CKD-aP in the US except in the dialysis clinics of Fresenius Medical Care North America (FMCNA), where VFMCRP and Cara were to promote IV Korsuva under a profit-sharing arrangement based on net FMCNA clinic sales recorded by Cara. Under the agreement, Cara had sole responsibility to promote IV Korsuva in the US in non-Fresenius Medical Care clinics.Contact and further information: Vifor Pharma Group Media RelationsInvestor Relations Nathalie PonnierJulien Vignot Global Head Corporate CommunicationsHead of Investor Relations +41 79 957 96 73+41 58 851 66 90 firstname.lastname@example.org@viforpharma.com Cara Therapeutics Media ContactInvestor Contact Annie StarrJanhavi Mohite 6 DegreesStern Investor Relations, Inc. 973-415-8838212-363-1200 email@example.com@sternir.com Conference Call Cara management will host a conference call today at 8:30 am EDT to discuss the licensing agreement. To participate in the conference call, please dial (855) 445-2816 (domestic) or (484) 756-4300 (international) and refer to conference ID 1891110. A live webcast of the call can be accessed under "Events and Presentations" in the News & Investors section of Cara’s website at www.CaraTherapeutics.com. An archived webcast recording will be available on the Cara website beginning approximately two hours after the call.Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care). Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348). For more information, please visit viforpharma.comCara Therapeutics is a clinical-stage biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors, or KORs. Cara is developing a novel and proprietary class of product candidates, led by KORSUVA™ (difelikefalin), a first-in-class KOR agonist that targets the body’s peripheral nervous system, as well as certain immune cells. In two Phase 3 trials, IV KORSUVA has demonstrated statistically significant reductions in itch intensity and concomitant improvement in quality of life measures in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP). Cara has successfully completed its Phase 2 trial of Oral KORSUVA for the treatment of pruritus in patients with CKD and is currently conducting Phase 2 trials of Oral KORSUVA in atopic dermatitis and primary biliary cholangitis patients with moderate-to-severe pruritus.CKD-aP is an intractable systemic itch condition that occurs with high frequency and intensity in patients with chronic kidney disease undergoing dialysis. Pruritus has also been reported in patients with stage III-V CKD who are not on dialysis. Aggregate, longitudinal, multi-country studies estimate the weighted prevalence of CKD-aP to be approximately 40 percent in patients on dialysis, with approximately 25 percent of patients reporting severe pruritus. The majority of dialysis patients (approximately 60-70 percent) report pruritus, with 30 to 40 percent reporting moderate or severe pruritus.1,2 Recent data from the ITCH National Registry Study showed that among those with pruritus, approximately 59 percent experienced symptoms daily or nearly daily for more than a year. Given its association with CKD/ESRD, most afflicted patients will continue to have symptoms for months or years, with currently employed antipruritic treatments, such as antihistamines and corticosteroids, unable to provide consistent, adequate relief. Moderate-to-severe chronic pruritus has repeatedly been shown to directly decrease quality of life, contribute to symptoms that impair quality of life (such as poor sleep quality), and is associated with depression.3 CKD-aP is also an independent predictor of mortality among haemodialysis patients, mainly related to increased risk of inflammation and infections.References: 1\. Pisoni RL, et al. Pruritus in haemodialysis patients: international results from the Dialysis Outcomes and Practice Patterns Study (DOPPS). Nephrol Dial Transplant. 2006; 21:3495-3505. 2\. Ramakrishnan K, et al. Clinical characteristics and outcomes of end-stage renal disease patients with selfreported pruritus symptoms. International Journal of Nephrology and Renovascular Disease. 2014; 7: 1-12. 3\. Mathur VS, et al.Forward-looking StatementsStatements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning plans, strategies and expectations for the future, including statements concerning the potential commercialization of IV KORSUVA by Vifor Pharma, the potential benefits of Vifor Pharma’s marketing IV KORSUVA in the United States through arrangement announced today, the potential of IV KORSUVA to address a significant unmet need, the potential equity investment, milestone and profit-sharing payments payable to Cara Therapeutics pursuant to the agreement and the expected timelines for planned regulatory submissions. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Some of these risks and uncertainties include, but are not limited to, those related to the initiation and conduct of clinical trials, the receipt of data sufficient to support regulatory submissions and required regulatory approvals of KORSUVA, and uncertainties regarding the rate and degree of market acceptance of IV KORSUVA, if approved for marketing, as well as those risks and uncertainties described more fully in Cara’s filings with the Securities and Exchange Commission, including the "Risk Factors" section of Cara’s Annual Report on Form 10-K for the year ended December 31, 2019, its Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 and its other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Cara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.*The FDA has conditionally accepted KORSUVA™ as the trade name for difelikefalin injection. CR845/difelikefalin is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.
Geneva, Switzerland and Boston, MA – October 20, 2020 – ObsEva SA (NASDAQ: OBSV), a clinical-stage biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health, today announced the presentation of a poster at the ASRM 2020 Virtual Scientific Congress and Expo.Poster number P-482: The Effect of the Oral Oxytocin Antagonist, Nolasiban, On Pregnancy Rates in Women Undergoing Embryo Transfer Following IVFDr. Georg Griesinger, Professor at Luebeck University, Germany, and chair of the Department of Gynecological Endocrinology and Reproductive Medicine, University Hospital of Schleswig-Holstein, is lead author of a poster presenting results from a meta-analysis of the clinical trials and a mechanism of action study of nolasiban, an oxytocin receptor antagonist being developed for its potential to increase pregnancy rates following in vitro fertilization (IVF). Results support the further evaluation of higher doses and/or alternate regimens of nolasiban. ObsEva is partnering with YuYuan BioScience Technology, a Chinese company, for the development of nolasiban.The related abstract is scheduled to be published online in the Fertility and Sterility Abstract Supplement in October 2020.About ObsEvaObsEva is a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on treating endometriosis, uterine fibroids, preterm labor, and improving embryo transfer (ET) outcomes following IVF. ObsEva is listed on the Nasdaq Global Select Market and is trading under the ticker symbol "OBSV" and on the SIX Swiss Exchange where it is trading under the ticker symbol “OBSN”. For more information, please visit www.ObsEva.com.About Nolasiban Nolasiban (previously known as OBE001), is an oral oxytocin receptor antagonist which was licensed from Merck KGaA, Darmstadt, Germany, in 2013. ObsEva retains worldwide, exclusive, commercial rights (ex China).About Assisted Reproductive Technology Infertility affects about 10% of reproductive-aged couples, with more than two million assisted reproductive technology (ART) treatments (including IVF and intracytoplasmic sperm injection (ICSI)) performed worldwide each year. In China, more than 950,000 ART cycles (IVF, ICSI, fetal ET) were performed in 2017 (National Health Commission of the PRC, presented at the 23rd International Federation of Fertility Societies conference in Shanghai, 2019).While the success of ART depends on multiple factors including ovarian response, fertilization, embryo quality and ET procedure, a successful pregnancy ultimately hinges on the receptivity of the uterus to accept embryo implantation. Uterine contractions at the time of ET, as well as suboptimal thickness of the uterine wall and insufficient blood flow to the uterus, may impair the implantation of the embryo.About YuYuan Bioscience TechnologyYuYuan Bioscience Technology is a leading biopharmaceutical company based in China focused on discovering, developing and commercializing innovative medicines for unmet medical needs in the assisted reproductive area. The company continues to introduce a competitive portfolio of therapeutic programs aimed at helping to bring more solutions to this field. YuYuan Bioscience has a top class leadership team with deep experience at assisted reproductive therapeutics and within biotech organizations. The team has a strong track record of success – successfully having taken drug candidates into clinical trials in China, secured regulatory approvals and achieved great market success. YuYuan Bioscience has always adhered to the development concept of “doing moral business, craving long-lasting career”, providing comprehensive, accurate and professional services for China's assisted reproductive medical field.Cautionary Note Regarding Forward Looking StatementsAny statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan," "potential," "will," and similar expressions, and are based on ObsEva’s current beliefs and expectations. These forward-looking statements include statements regarding the potential of nolasiban to improve pregnancy rates following IVF. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials and clinical development and related regulatory reviews and approvals, including the risk that the results of earlier clinical trials may not be predictive of the results of later-stage clinical trials, related interactions with regulators, the impact of the novel coronavirus outbreak, and other risks and uncertainties that are described in the Risk Factors section of ObsEva’s Annual Report on Form 20-F for the year ended December 31, 2019, the Risk Factors disclosed in ObsEva’s Report on Form 6-K filed with the Securities and Exchange Commission (SEC) on August 6, 2020 and other filings ObsEva makes with the SEC. These documents are available on the Investors page of ObsEva’s website at http://www.obseva.com. 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Priceless Planet Coalition Expands, Unites Businesses and Consumers Worldwide to Preserve the Environment
Recruitment on track to be completed before year-end Gosselies, Belgium, 20 October 2020, 7am CEST – BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the cell therapy company addressing unmet medical needs in orthopedics and other diseases, today announces it has already completed over 50% of its treated patients in its Phase III clinical study with the improved viscosupplement, JTA-004, in patients with knee osteoarthritis. At the current recruitment rate, and assuming no further significant disruption of health care systems worldwide due to the continuing COVID-19 pandemic, Bone Therapeutics expects to complete patient enrollment before year-end. Topline results are anticipated on the 3-month primary endpoint and 6-month follow-up period in the second half of 2021.“The COVID-19 pandemic has posed major challenges to patient recruitment across the industry. In spite of this, Bone Therapeutics, with the support of NBCD, has been able to treat over 50% of the patients in the JTA-004 Phase III trial in just over four months, since it started recruiting in mid-May,” said Miguel Forte, CEO, Bone Therapeutics. “This significant progress keeps us on schedule to complete recruitment before the end of the year and release topline data by second half next year. A positive outcome for this pivotal study would be a major achievement for the high unmet medical need of the estimated 250 million patients worldwide suffering from knee osteoarthritis, a very painful and debilitating condition.”The JTA-004 Phase III study is a controlled, randomized, double-blind trial. It is evaluating the potential of a single, intra-articular injection of JTA-004 to reduce osteoarthritic pain in the knee compared to placebo or Hylan G-F 20, the leading current osteoarthritis treatment on the market. The study is being conducted in six European countries as well as Hong Kong SAR. Since the initiation of the recruitment in mid-May 2020, 50% of the targeted assessable patients have already been treated. The study plans to enroll 676 patients fulfilling the protocol criteria with mild to moderate symptomatic knee osteoarthritis.JTA-004 is Bone Therapeutics’ next generation of intra-articular injectables for the treatment of osteoarthritic pain in the knee. Consisting of a unique mix of hyaluronic acid - a natural component of knee synovial fluid, plasma proteins, and a fast-acting analgesic, JTA-004 intends to provide added lubrication and protection to the cartilage of the arthritic joint and to alleviate osteoarthritic pain. In a previous randomized, double-blind Phase II study involving 164 patients, JTA-004 showed superior clinical benefit with an improved pain relief at 3 and 6 months compared to Hylan G-F 20, the global market leader in osteoarthritis treatment. About Bone TherapeuticsBone Therapeutics is a leading biotech company focused on the development of innovative products to address high unmet needs in orthopedics and other diseases. The Company has a, diversified portfolio of cell and biologic therapies at different stages ranging from pre-clinical programs in immunomodulation to mid-to-late stage clinical development for orthopedic conditions, targeting markets with large unmet medical needs and limited innovation.Osteoarthritis (OA), also known as degenerative joint disease, is the most common chronic joint condition in which the protective cartilage in the joints progressively break down resulting in joint pain, swelling, stiffness and limited range of motion. The knee is one of the joints that are mostly affected by osteoarthritis, with an estimated 250 million cases worldwide.Bone Therapeutics is developing an off-the-shelf next-generation improved viscosupplement, JTA-004, which is currently in Phase III development for the treatment of pain in knee osteoarthritis. Consisting of a unique combination of plasma proteins, hyaluronic acid - a natural component of knee synovial fluid, and a fast-acting analgesic, JTA-004 intends to provide added lubrication and protection to the cartilage of the arthritic joint and to alleviate osteoarthritic pain and inflammation. Positive Phase IIb efficacy results in patients with knee osteoarthritis showed a statistically significant improvement in pain relief compared to a leading viscosupplement.Bone Therapeutics’ cell therapy products are manufactured to the highest GMP standards and are protected by a broad IP (Intellectual Property) portfolio covering ten patent families as well as knowhow. The Company is based in the BioPark in Gosselies, Belgium. Further information is available at www.bonetherapeutics.com. For further information, please contact:Bone Therapeutics SA Miguel Forte, MD, PhD, Chief Executive Officer Jean-Luc Vandebroek, Chief Financial Officer Tel: +32 (0)71 12 10 00 email@example.comFor Belgian Media and Investor Enquiries: Bepublic Catherine Haquenne Tel: +32 (0)497 75 63 56 firstname.lastname@example.orgInternational Media Enquiries: Image Box Communications Neil Hunter / Michelle Boxall Tel: +44 (0)20 8943 4685 email@example.com / firstname.lastname@example.orgFor French Media and Investor Enquiries: NewCap Investor Relations & Financial Communications Pierre Laurent, Louis-Victor Delouvrier and Arthur Rouillé Tel: +33 (0)1 44 71 94 94 email@example.comFor US Media and Investor Enquiries: LHA Investor Relations Yvonne Briggs Tel: +1 310 691 7100 firstname.lastname@example.orgCertain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors’ current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.