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Month: August 2022

MT Højgaard Holding A/S: MT Højgaard Danmark and N.V. BESIX S.A. awarded conditional DKK 2.6 bn contract for construction of the Nordhavn tunnel

MT Højgaard Holding’s business unit MT Højgaard Danmark and Belgian joint venture partner N.V. BESIX S.A. have entered a conditional contract with the Danish Road Directorate for the construction of the Nordhavn tunnel in Copenhagen. The contract value is DKK 2,585 million, and signing is expected after expiration of the standstill period in mid-September 2022. Planning and construction of the building site by Svanemøllen bay will commence immediately after signing of the contract. The joint venture partners N.V. BESIX S.A. and MT Højgaard Danmark will collaborate closely with suppliers Niras, Bravida Danmark and Jacobs Sverige AB for the construction of the Nordhavn tunnel, which is to be commissioned in 2027 and ensure more direct access to the developing areas in the outer and inner Nordhavn. The tunnel will connect Østerbro with outer...

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Scilex Holding Company, a Sorrento Company, Announces That the FDA Has Granted Fast Track Designation for SP-103 (Lidocaine Topical System) 5.4%, Next Generation Triple Strength Formulation of ZTlido®, for the Treatment of Acute Low Back Pain (LBP)

SP-103 receives Fast Track Designation, which makes it eligible for some or all of the following:More frequent meetings or written communication with the FDA to discuss the SP-103 development plan and ensure collection of appropriate data needed to support drug approval.Eligibility for Accelerated Approval or Priority Review, if relevant criteria are met.Rolling Review, which means that Scilex can submit completed sections of its New Drug Application (NDA) for review by the FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed.Despite an overall lack of evidence to support their efficacy, opioids continue to be prescribed to treat acute LBP when patients seek medical evaluation. According to the CDC in 2020, LBP was the most common type of pain reported by patients,...

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UPDATE — Privia Health Reports Results in CMS’ Medicare Shared Savings Program

2021 Performance Across All Markets Demonstrates Improved Care and Lower Costs Privia ACOs Delivered Total Annual Average Expenditures 15% Lower than Median MSSP ACO and 24% Lower than Total Fee for Service Medicare $99.9 Million in Shared Savings Delivered across Georgia, Maryland, Texas, Virginia and Washington, DC ARLINGTON, Va., Aug. 30, 2022 (GLOBE NEWSWIRE) — Privia Health Group, Inc. (Nasdaq: PRVA) today announced that its Accountable Care Organizations (“ACOs”) delivered quality care and improved patient outcomes, and achieved shared savings of $99.9 million through the Medicare Shared Savings Program (“MSSP”). Privia’s ACOs (collectively “Privia Quality Network”) provided high-value, cost-efficient care to more than 112,000 Medicare beneficiaries in 2021. “Navigating care options for patients during the coronavirus pandemic...

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XR Immersive Tech Announces Record Second Quarter Revenue & Corporate Update

VANCOUVER, British Columbia, Aug. 30, 2022 (GLOBE NEWSWIRE) — XR Immersive Tech Inc. (“XRi” or “Immersive Tech”, or the “Company”) (CSE:VRAR) (FSE:79W) (OTCQB: FNTTF) a leading location-based virtual reality (“LBVR”) content distribution and facility management platform, today announced results for its second quarter and first half of its fiscal 2022 year ended June 30, 2022 as well as providing a mid-year corporate update. “We had a great second quarter, and first half of 2022, with revenues climbing sharply including a number of strategic key milestones reached which I am excited to share,” said Tim Bieber XRi CEO. XRi delivered the following results for its second quarter and first half of its fiscal 2022 year: In the Company’s second quarter revenue was $348,328 with associated cost of goods sold of $71,375, a revenue...

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Cal Water Applauds Passage of Important Water Conservation Bill SB 1469 (Bradford/Becker)

Broad coalition of labor, environmental, business, consumer, and water groups urge Governor Newsom to sign the bill. SAN JOSE, Calif., Aug. 30, 2022 (GLOBE NEWSWIRE) — California Water Service (Cal Water) today applauded passage of SB 1469 (Sens. Bradford, Becker), which would make permanent a proven program that has encouraged California water customers to reduce their water use and helped keep water bills low for all customers, particularly low-income customers. The bill now goes to Governor Newsom’s desk. The bill has broad support among labor, business, consumer and environmental groups, low-income advocates, local governments, and many others who encourage the Governor to sign the bill. The statement below can be attributed to Martin Kropelnicki, Cal Water’s President and CEO. “SB 1469 is a major game changer that will increase...

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Mesoblast Reports Financial Results and Operational Highlights for Fiscal Year Ended June 30, 2022

At June 30, 2022, cash-on-hand was US$60.4 million with pro-forma US$105.5 million after raising gross proceeds of US$45 million via a private placement in August, 2022 Up to an additional US$40 million available from existing facilities subject to certain milestones Net operating spend of US$65.8 million for the 12 months ended June 2022, a 35% reduction on comparative year, with continued focus on cost control BLA resubmission for remestemcel-L in children with SR-aGVHD expected to be filed this quarter, with potential US approval Q1 CY2023 Plan to meet with FDA next quarter under existing regenerative medicine advanced therapy (RMAT) designation to discuss common mechanism of action in HFrEF including those with LVADs, and potential pathway to marketing approval FDA clearance by year end 2022 to commence a pivotal study for potential...

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Tinybeans Releases Record FY22 Results and Preliminary 4E Report

NEW YORK, Aug. 30, 2022 (GLOBE NEWSWIRE) — Tinybeans Group Limited (ASX: TNY) (OTCQB: TNYYF) (“Tinybeans” or “the Company”), the only personalized platform trusted by parents to help them raise amazing kids, is pleased to share its record preliminary results and the Appendix 4E for fiscal year 2022. The operating results for the period are materially consistent with the headline preliminary results released by the Company on July 28th. The results are subject to completion of the year end audit and audited results are expected to be released in September. FY22 Operational HighlightsRevenue increased to a record US$10.9m, up 34% pcp Advertising revenue hit a record US$9m, up 31% pcp, won 17 $100k deals vs 13 in FY21 Subscription revenue hit a record US$1.5m, up 77% pcp At 56% growth in direct advertising revenues, significantly...

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Perseus delivers record financial performance in FY22

Perth, Aug. 31, 2022 (GLOBE NEWSWIRE) — PERSEUS DELIVERS RECORD FINANCIAL PERFORMANCE IN FY22 Perth, Western Australia/ August 31, 2022/ African gold producer, Perseus Mining Limited (ASX/TSX: PRU), has released its Financial Report for the financial year ending 30 June 2022 (FY22), with record performance across all key metrics relative to the prior financial year. Perseus has recognised the Company’s strong operating performance by including a bonus dividend in its final dividend for FY22. highlightsRevenue of $1,126 million1, up 66% on FY21. EBITDA of $564.1 million, up 86% on FY21. Profit after tax of $279.9 million, up 101% on FY21, after exploration write down of $43.4 million. Basic earnings per share of 18.8 cents per share, up 96% year-on-year. Net cash inflows from operating activities of $522.9 million or 42.01 cents...

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Leading Edge Materials Reports Management Changes – Filip Kozlowski, CEO Resigns

Vancouver, August 30, 2022 – Leading Edge Materials Corp. (“Leading Edge Materials” or the “Company“) (TSXV: LEM) (Nasdaq First North: LEMSE) (OTCQB: LEMIF) announces a change in senior Management with the resignation of Mr. Filip Kozlowski, CEO of the Company. Mr. Kozlowski will be resigning for personal reasons but will continue to be available as consultant to the Company to ensure a smooth transition and deliver support on an as needs basis in advancement of the Company’s projects. Mr. Kozlowski’s resignation will be effective as of October 14, 2022. Mr. Eric Krafft, Director of the Company, will be named the interim CEO after October 14, 2022. Lars Eric Johansson, Chairman stated “We thank Mr. Kozlowski for his hard work and commitment over the last two years and wish him well for the future. We appreciate his ongoing input as we...

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GT Biopharma Affirms Manufacturing Timeline For Lead Investigational Asset GTB-3650

GTB-3650’s IND application with the FDA expected by end of first quarter of 2023BRISBANE, Calif., Aug. 30, 2022 (GLOBE NEWSWIRE) — GT Biopharma, Inc. (the “Company” or “GTB”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager, TriKE® platform, today announced entering into a Settlement and Investment Agreement (the “Agreement”) with its contract manufacturing partner Cytovance Biologics. The signed Agreement, covers all work required to facilitate the registration of an investigational new drug (IND) filing with the U.S. Food and Drug Administration (“FDA”) of its lead investigational asset GTB-3650. GTB-3650 is the Company’s lead second-generation Tri-Specific Killer Engager TriKE® program currently...

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