Stockwinners Market Radar for October 05, 2022 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

21:06 EDT Xometry CEO sells $1.17M in common stock - In a regulatory filing, Xometry disclosed that its CEO Randolph Altschuler sold 20K shares of common stock on October 3rd in a total transaction size of $1.17M.

18:53 EDT Compass jumps 15% on Insider report regarding potential take-private deal

18:04 EDT Harrow Health announces sale of non-ophthalmic compounding business - Harrow announced the sale of its non-ophthalmic compounding business to Innovation Compounding Pharmacy, an affiliate of Revelation Pharma Corporation. Pursuant to the terms of the transaction, Revelation purchased the assets of Harrow's non-ophthalmic compounding business, including its formulations, customer accounts, and other related assets. The transaction did not involve a pharmaceutical production or dispensing facility. Harrow will continue to support Revelation during an estimated three-month transition period, and Revelation will offer employment to Harrow employees supporting the acquired business.

17:44 EDT Cboe Global Markets reports Q1 options ADV of 59.2M contracts - The company states: "For the second consecutive month, total U.S. options volume reached an all-time high with volume across all four Cboe options exchanges of 309.3 million contracts in September, up two percent from the previous record in August. Trading in S&P 500 Index options reached an all-time high, setting multiple records, including: A new monthly volume record of 59.2 million contracts, up 15 percent from the previous record in August. Average Daily Volume (ADV) in September also reached a new all-time high of 2.8 million contracts. A new single-day volume record on September 23 with 3.8 million contracts traded, beating the previous record of 3.6 million on February 28, 2020. SPX Weeklys Tuesdays and Thursdays options saw a total 14.6 million contracts traded, the highest monthly volume since launch. In addition, records were set in SPX options expiring on the trade date (zero-days-to-expiry), including: A new monthly ADV record of 1.2 million contracts, up 26 percent from the previous record in August. A new single-day volume record on September 2 with 1.5 million contracts traded, surpassing the previous high of 1.3 million on August 26."

17:26 EDT SEACOR Marine Holdings sells minority interests in Mexico - SEACOR Marine Holdings announced the sale of its minority equity interests in joint ventures in Mexico and two refinancing transactions that extended more than $175M of the company's near term maturities by three years to 2026. The company entered into an agreement with Proyectos Globales de Energia CME for the sale of the company's minority equity interests in its unconsolidated joint ventures in Mexico and a series of related asset swaps for aggregate consideration of $66M cash. The company acquired 100% of Mantenimiento Express Maritimo, or MEXMAR, outstanding secured loan from MEXMAR's existing lenders for $28.8M. The company also entered into an amendment of its senior secured term loan facility. In connection with the amendment, the Credit Facility will have an extended tranche of $54.9M, maturing in March 2026. The extended tranche will bear interest at a rate of 4.75% plus SOFR. The remaining $19.8M of the loan will maintain its existing terms and mature in September 2023. In connection with this transaction, the company made a pre-payment of $5.3M. The company has entered into an exchange transaction with certain funds affiliated with Carlyle pursuant to which the entire $125.0M of the company's 4.25% Convertible Senior Notes due 2023 were exchanged for $90.0M in aggregate principal amount of the company's new 8.0% / 9.5% Senior PIK Toggle Notes due 2026 and $35.0M in aggregate principal amount of the company's new 4.25% Convertible Senior Notes due 2026.

17:11 EDT AbbVie says Q3 IPR&D expenses to have unfavorable 2c per share impact - The company states: "Reported GAAP earnings and adjusted non-GAAP earnings for the third quarter of 2022 are expected to include acquired IPR&D and milestones expense of $40 million on a pre-tax basis, representing an unfavorable impact of $0.02 to both GAAP diluted earnings per share and adjusted non-GAAP diluted earnings per share. Results for the quarter ended September 30, 2022 have not been finalized and are subject to our financial statement closing procedures. While acquired IPR&D and milestones expense may be incurred upon execution of collaborations, licensing agreements, and other asset acquisitions, AbbVie does not forecast acquired IPR&D and milestones expense due to uncertainty of the future occurrence and timing of these transactions. Adjusted diluted earnings per share guidance for 2022 previously announced on July 29, 2022 excluded the impact of acquired IPR&D and milestones expense that may be incurred beyond the second quarter of 2022. AbbVie's full-year 2022 adjusted diluted earnings per share guidance range, including the impact of third quarter 2022 acquired IPR&D and milestones expense, is $13.76 - $13.96. AbbVie's third quarter 2022 adjusted diluted earnings per share guidance range, including the impact of third quarter 2022 acquired IPR&D and milestones expense, is $3.53 - $3.57." The company guided Q3 EPS at $3.55-$3.59 on July 29th.

17:01 EDT Biofrontera Inc. sees Q3 product revenue at about $4.3M - The company states: "Product revenues for the third quarter of 2022 are anticipated to be approximately $4.3 million, consistent with the third quarter of 2021. These projections result in product revenues for the first nine months of 2022 expected to be approximately $18.5 million up approximately 24% compared with the first nine months of 2021. Year-to-date 2022 product revenues are at a record high, and are up approximately 26% over the comparable period in the pre-Covid year 2019."

16:58 EDT Nordstrom Chief Technology & Information Officer, Edmond Mesrobian, to step down - On September 30, Edmond Mesrobian, the company's Chief Technology and Information Officer, informed the company that he was stepping down from his position. His last day with the company will be October 14.

16:46 EDT Under Armour announces executive leadership changes - Under Armour announced that effective October 24, David Baxter and Mehri Shadman will join its executive leadership team. Baxter is set to assume a regional leadership role as President of the Americas, succeeding Stephanie Pugliese, who will be stepping down from her role and leaving the company. Pugliese will remain until early 2023 to support Baxter's transition. Shadman has been appointed Chief Legal Officer and Corporate Secretary as John Stanton, UA's current chief legal officer, has decided to retire at the end of 2022 after 16 years of service.

16:37 EDT Greenlight Capital announces underwriting leadership changes - Greenlight Capital announces the following promotions within its underwriting leadership teams:Regan Cairns has been promoted as Chief Underwriting Officer of Greenlight Reinsurance , focusing on Financial Risks, North American Casualty, and Property classes. Finbar Griffin has been promoted as Chief Underwriting Officer of Greenlight Reinsurance Ireland, dac , focusing on London Market Specialty and Funds at Lloyd's classes. Kagabo Ngiruwonsanga has been promoted as Head of Underwriting of Innovations and will manage and oversee underwriting opportunities derived from Greenlight Re Innovations.*

16:33 EDT NLS Pharmaceutics receives noncompliance letter from Nasdaq - NLS Pharmaceutics announced that it received a determination letter from the staff of the Listing Qualifications Department of Nasdaq notifying the company of the staff's determination that, unless the company timely requests a hearing before a Nasdaq Hearings Panel, the company's securities would be subject to delisting from The Nasdaq Capital Market due to the company's failure to regain compliance with the minimum stockholders' equity requirement for continued listing on Nasdaq, as set forth in Nasdaq Listing Rule 5550. Accordingly, the company intends to timely request a hearing before the panel. The hearing request will stay any suspension or delisting action pending the hearing and the expiration of any additional extension period granted by the panel following the hearing. In that regard, pursuant to the Nasdaq Listing Rules, the panel has the discretion to grant the company an extension through March 28, 2023.

16:33 EDT International Game wins 10-year contract with Texas Lottery Commission - International Game Technology announced that its subsidiary, IGT Global Solutions Corporation, has signed a new 10-year scratch ticket printing and services contract with the Texas Lottery Commission. Following a competitive procurement, IGT was awarded the printing contract to provide scratch ticket content and supporting services. The new contract will extend IGT's partnership with the Texas Lottery through August 2034.

16:31 EDT Oshkosh President of Oshkosh Defense to retire on November 1 - Oshkosh "announced that John Bryant, executive vice president and president of Oshkosh Defense, will retire on November 1, 2022, following 12 years with the company. Consistent with the company's succession planning process, Tim Bleck, vice president of finance for the Defense segment has been appointed as Bryant's successor. Bryant will remain in an advisory role to support the transition through June 30, 2023."

16:21 EDT Life Storage says all 161 properties in Florida operational after Ian - Life Storage "announced that all 161 of its wholly owned and managed properties in Florida, including 72 properties stretching from the Tampa vicinity down to the more highly impacted area of Naples, are operational. The Company continues to assess preliminary damage related to Hurricane Ian and will provide additional information and updates in conjunction with the Company's next scheduled earnings release and conference call for the third quarter."

16:08 EDT Assembly Biosciences CEO John McHutchison to retire, Jason Okazaki to succeed - Assembly Biosciences (ASMB) announced that John McHutchison, CEO, will retire as CEO at the end of 2022. McHutchison will continue to serve on Assembly Bio's board of directors, including assuming the role of chairman of the Science and Technology Committee. Assembly Bio's board of directors has unanimously elected Jason Okazaki, the company's current president and COO, as chief executive officer and a member of the board upon Dr. McHutchison's retirement. Prior to joining Assembly Bio, Okazaki was senior vice president, legal and assistant secretary at Gilead Sciences (GILD).

16:06 EDT Apollo Medical to acquire Valley Oaks Medical Group, terms not disclosed - Apollo Medical Holdings announced that it and its affiliated professional entity have entered into a definitive agreement to acquire 100% of the fully diluted capitalization and assets relating to nine primary care clinics in Las Vegas, Houston, and Fort Worth operating as Valley Oaks Medical Group. The company anticipates closing this transaction by the end of the fourth quarter of 2022 and will fund the transaction with cash on hand.

16:01 EDT Central Valley Community names Dawn Crusinberry interim CFO - Central Valley Community Bank has appointed Dawn P. Crusinberry, Senior Vice President, Controller, as the Company's Interim EVP and CFO, effective September 30, 2022. She succeeds David A. Kinross, Executive Vice President, CFO, who will remain in a transitional finance role as the Company's Strategic Growth Advisor effective September 30, 2022. The professional recruitment firm of Chrisman & Company has been contracted to commence an executive search for a permanent CFO.

14:29 EDT Twitter adds option to include multiple types of media in one Tweet - Twitter stated in a blog post: "Sometimes you need more than one kind of media to express yourself the way you want. Don't worry, we've got you. Today Twitter is introducing a new way to share different types of visual content - videos, images, and GIFs - together in a single Tweet... You can add up to four videos, images, and/or GIFs per Tweet. The update is currently available on iOS and Android, however Tweets with different content types can be consumed on all platforms." Reference Link

14:22 EDT Partner Communications Company Ltd (ADR) trading resumes

14:02 EDT F.N.B. reports final regulatory approvals for UB Bancorp merger - F.N.B. Corporation (FNB) announced it has received all regulatory clearances for its proposed merger with UB Bancorp (UBNC). The Board of Governors of the Federal Reserve System and the Office of the Comptroller of the Currency have provided final clearance for the pending FNB-UB Bancorp merger as well as the merger of UB Bancorp's bank subsidiary, Union Bank, into FNB's bank subsidiary, First National Bank of Pennsylvania. UB Bancorp stockholders approved the proposed merger at a special meeting on September 21. As announced on June 1, UB Bancorp stockholders will be entitled to receive 1.61 shares of FNB common stock for each share of UB Bancorp common stock they own. The exchange ratio is fixed, and the transaction is expected to qualify as a tax-free exchange for UB Bancorp stockholders. "The proposed merger between FNB and UB Bancorp will further increase FNB's presence in North Carolina, where the combined organization will operate approximately 100 convenient locations and assume the eighth largest deposit market share position1. Following the proposed merger with UB Bancorp on a proforma basis, FNB will have approximately $43 billion in total assets, $35 billion in deposits and $29 billion in total loans," the company said. The completion of the merger remains subject to the satisfaction of certain routine and customary closing conditions. The merger is expected to close and convert in December 2022.

13:37 EDT North American rail traffic down 1.1% for the week ending October 1 - The Association of American Railroads or AAR, reported U.S. rail traffic for the week ending October 1, as well as volumes for September . U.S. railroads originated 928,590 carloads in September, down 1.1%, or 10,639 carloads, from September 2021. U.S. railroads also originated 1,011,304 containers and trailers in September 2022, down 4.8%, or 51,039 units, from the same month last year. Combined U.S. carload and intermodal originations in September were 1,939,894, down 3.1%, or 61,678 carloads and intermodal units from September 2021. In September, six of the 20 carload commodity categories tracked by the AAR each month saw carload gains compared with September 2021. These included: crushed stone, sand & gravel, up 8,987 carloads or 11.2%; motor vehicles & parts, up 8,380 carloads or 18%; and coal, up 4,886 carloads or 1.8%. Commodities that saw declines in September 2022 from September 2021 included: primary metal products, down 6,341 carloads or 16.6%; all other carloads, down 4,879 carloads or 21%; and grain, down 4,227 carloads or 5%. North American rail volume for the week ending October 1, on 12 reporting U.S., Canadian and Mexican railroads totaled 337,140 carloads, down 0.8 percent compared with the same week last year, and 350,834 intermodal units, down 1.3% compared with last year. Total combined weekly rail traffic in North America was 687,974 carloads and intermodal units, down 1.1%. North American rail volume for the first 39 weeks of 2022 was 26,388,292 carloads and intermodal units, down 2.3 percent compared with 2021. Publicly traded companies in the space include CSX (CSX), Canadian National (CNI), Canadian Pacific (CP), Kansas City Southern (KSU), Norfolk Southern (NSC), Union Pacific (UNP), FreightCar America (RAIL), Trinity Industries (TRN), Greenbrier (GBX) and Wabtec (WAB). Reference Link

12:11 EDT Spotify acquires harmful content detection firm Kinzen, terms not disclosed - Spotify announced it acquired Dublin, Ireland-based Kinzen, a firm focused on protecting online communities from harmful content. The company said, "Kinzen's advanced technology and deep expertise will help us more effectively deliver a safe, enjoyable experience on our platform around the world. Spotify's current partnership with Kinzen, which began in 2020, has been critical to enhancing our approach to platform safety. The company's unique technology is particularly suited for podcasting and audio formats, making its value to Spotify clear and unmatched. The technology the Kinzen team brings to Spotify combines machine learning and human expertise-backed by analysis from leading local academics and journalists-to analyze potential harmful content and hate speech in multiple languages and countries...Given the complexity of analyzing audio content in hundreds of languages and dialects, and the challenges in effectively evaluating the nuance and intent of that content, the acquisition of Kinzen will help Spotify better understand the abuse landscape and identify emerging threats on the platform. Reference Link

12:00 EDT MFA Financial falls -9.9% - MFA Financial is down -9.9%, or -84c to $7.70.

12:00 EDT Sunlands Online falls -10.9% - Sunlands Online is down -10.9%, or -47c to $3.82.

12:00 EDT Debt Resolve rises 9.8% - Debt Resolve is up 9.8%, or $5.94 to $66.42.

11:59 EDT Noble Corp. completes divestment of five jackups - Noble Corporation announced it has completed the sale of the Noble Hans Deul, Noble Sam Hartley, Noble Sam Turner, Noble Houston Colbert, and Noble Lloyd Noble to a subsidiary of Shelf Drilling, for cash proceeds of $375M as part of the recently completed business combination with Maersk Drilling. As previously disclosed in the June 23, 2022 Remedy Rigs sale announcement, all onshore and offshore related staff, support and infrastructure associated with these rigs is hereby transferred to Shelf Drilling, while Noble will continue to operate the Noble Lloyd Noble under a bareboat charter with Shelf Drilling through the conclusion of that rig's current drilling contract with Equinor which is expected to finish in the second quarter of 2023.

11:29 EDT Kroger's Home Chef enters collaboration with Rachael Ray - The Kroger Co. shared that Home Chef has collaborated with television host, author and philanthropist Rachael Ray to bring a new line of meal kits to stores across the Kroger Family of Companies. The first Rachael Ray Home Chef meal kit, in stores now, guides customers through a recipe created by Ray herself for a Steakhouse Burger with Dijon mushrooms and onions. The series will include meals like Pork Lo Mein with carrots and bok choy, Spicy Sloppy Joes with oven fries, and more. New meal kits featuring Rachael Ray recipes will be available each month in more than 1,300 stores across the Kroger Family of Companies through mid-March.

11:19 EDT BAE Systems receives five-year, $383M services contract - BAE Systems has received a five-year, $383M contract from the U.S. Army to perform technical and sustainment support services for its fleet of Bradley Fighting Vehicles and M993 Multiple Launch Rocket System carriers. Under the contract, the BAE Systems System Technical Support and Sustainment System Technical Support teams will provide on-going engineering and logistics services to keep the family of Bradley Fighting Vehicles ready to support Soldiers' missions, the company said in a statement.

11:07 EDT Chardan NexTech Acquisition 2 Corp trading halted, volatility trading pause

11:03 EDT Republic First Bancorp to appeal Nasdaq delisting determination - Republic First Bancorp, the holding company for Republic First Bank d/b/a Republic Bank, announced that on September 29, the company was notified by the Listing Qualifications Department of Nasdaq that, based upon the company's continued non-compliance with the filing requirement, the company's securities were subject to delisting unless the company requests a hearing before the Nasdaq Hearings Panel. "The company intends to request a hearing, which will stay any further action by the Staff, and to request a further stay of any suspension action by the Panel pending the ultimate conclusion of the hearing process. At the hearing, the company will present its plan to regain compliance with the filing requirement and request an extension of time to do so... The company expects to file the reports in the fourth quarter of 2022. The company is currently conducting its review of and procedures with respect to the reports and associated financial statements. Although the company is working diligently to file these reports as soon as possible, there can be no assurance that such reports will be filed in the fourth quarter of 2022 or before any hearing before the Nasdaq Hearings Panel, or that the Nasdaq Hearings Panel will grant the company's planned request for a stay pending the hearing," Republic First Bancorp stated.

10:43 EDT FingerMotion Inc trading resumes

10:38 EDT FingerMotion Inc trading halted, volatility trading pause

10:07 EDT Tyson Foods to shift multiple corporate offices to world headquarters - Tyson Foods announced plans to bring together all its corporate team members from the Chicago, Downers Grove and Dakota Dunes area corporate locations to its world headquarters in Springdale, Arkansas. The move will foster closer collaboration, enhance team member agility and enable faster decision making, positioning Tyson to win with its team members, customers, and consumers. Team members will begin the phased relocation in early 2023. Tyson is also announcing the expansion of Tyson's world headquarters, which will include indoor and outdoor spaces designed to foster collaboration, connection and creativity.

10:04 EDT Pharvaris NV trading resumes

10:00 EDT ProShares Ultra Silver falls -8.8% - ProShares Ultra Silver is down -8.8%, or -$2.24 to $23.16.

10:00 EDT Direxion Daily Gold Miners Bear 3X ETF rises 7.0% - Direxion Daily Gold Miners Bear 3X ETF is up 7.0%, or $1.51 to $23.01.

10:00 EDT Direxion Daily Junior Gold Miners Index Bear 3x Shares rises 8.5% - Direxion Daily Junior Gold Miners Index Bear 3x Shares is up 8.5%, or $1.02 to $12.97.

09:54 EDT TOP SHIPS Inc trading resumes

09:49 EDT TOP SHIPS Inc trading halted, volatility trading pause

09:47 EDT Lumen falls -7.5% - Lumen is down -7.5%, or -60c to $7.44.

09:47 EDT Direxion Daily Gold Miners Bear 3X ETF rises 5.5% - Direxion Daily Gold Miners Bear 3X ETF is up 5.5%, or $1.18 to $22.68.

09:47 EDT Direxion Daily Junior Gold Miners Index Bear 3x Shares rises 6.5% - Direxion Daily Junior Gold Miners Index Bear 3x Shares is up 6.5%, or 78c to $12.73.

09:44 EDT Monro reports majority of Tire Choice locations in Florida open - Monro announces that six of its Tire Choice Auto Service Center locations in Florida are closed in the wake of Hurricane Ian. The remaining 102 stores are fully operational and available to help residents that have been impacted by the hurricane. The six locations closed at this time include: Four stores - two in Cape Coral and one each in Port Charlotte and Venice - that are temporarily closed due to power outages. They will re-open as soon as power is restored, and the buildings are declared safe. Officials anticipate the stores will resume business by Friday. Two locations - one on Cleveland Avenue in Fort Myers and one on Central Avenue in Naples - sustained significant damage from the storm's high winds and flooding. They will be closed until further notice. Monro also reports that all 160 Tire Choice Auto Service Centers and Mr. Tire Auto Service Centers in Georgia, North and South Carolina, and Virginia are open and operational after Post-Tropical Storm Ian continued its slow path north over the weekend. Those states experienced high winds and flooding.

09:41 EDT PureTech Health PLC (ADR) trading halted, volatility trading pause

09:37 EDT Stagwell acquires creative agency Wolfgang, terms undisclosed - Stagwell announced the acquisition of creative agency Wolfgang. Stagwell acquired a minority interest in Wolfgang in 2019. Terms of the deal were not disclosed. Colin Jeffery, currently Chief Creative Officer of Wolfgang, will become the CCO of Doner Partners Network. Jeffery will oversee Doner and Wolfgang's creative departments in his newly appointed role.

09:32 EDT SHF Holdings Inc trading halted, volatility trading pause

09:23 EDT MarketAxess reports September total trading average daily volume of $32.6B - MarketAxess announced monthly trading volume for September 2022 and preliminary variable transaction fees per million for the quarter ended September 30, 2022. Select September 2022 highlights include: Estimated market share exceeded 20% across three major product areas for the first time in our history, with U.S. high-yield achieving record estimated market share of 21.3%, an increase of 730 basis points, joining U.S high-grade and emerging markets with estimated market share in excess of 20%; $32.6B in total trading average daily volume, up 23%, driven by a 20% increase in total credit ADV to $12.2B and a 24% increase in U.S. Treasury ADV to $19.9B; 21.4% composite corporate bond estimated market share, up from 17.9%; 1.7% estimated U.S. high-grade estimated market share, up from 20.1%, on ADV of $5.7 billion, representing an increase of 24%; Record 21.3% estimated U.S. high-yield market share, up from 14.0%, on ADV of $1.8B, representing an increase of 38%; Emerging markets ADV of $2.8B, up 6%; up approximately 11% excluding the impact of foreign currency fluctuations.

09:20 EDT Xponential Fitness debuts workouts on Lululemon Studio - Xponential Fitness (XPOF) announced the debut of its workouts across four brands on Lululemon Studio (LULU). Launched October 5, the new service from lululemon builds upon more than 10,000 on-demand and live-streamed classes that have been available with a Mirror subscription, and adds a breadth of content from notable fitness and wellness partners like Xponential Fitness. Members of lululemon Studio can now stream Pure Barre, Rumble, AKT and YogaSix classes, as well as sign up for discounted classes at the brands' hundreds of brick-and-mortar locations across the country.

09:10 EDT INDIEV, Foxconn sign MOU to produce prototype INDI One in Ohio - INDIEV and Hon Hai Technology Group (HNHPF) announced the signing of a Memorandum of Understanding, paving the way for Foxconn Ohio to manufacture the first INDI One prototype vehicles. Foxconn assumed manufacturing operations at its Ohio facility after completing an Asset Purchase Agreement with Lordstown Motors (RIDE) in May 2022. At present, the electric pickup truck production line in the facility has entered commercial production, and the tractor vehicle production line is expected to begin in the first quarter of 2023. This MOU is the newest electric vehicles manufacturing opportunity confirmed for Foxconn following the closing of the APA, with the binding provision to build the INDI One prototype vehicles at Foxconn Ohio. This MOU also serves as first steps towards delivering vehicles to customers for INDIEV, who began development of the INDI One in 2017, and revealed the vehicle publicly in October of 2021.

09:08 EDT Definitive Healthcare joins the United Nations Global Compact - Definitive Healthcare announced it has joined the United Nations Global Compact, the largest corporate sustainability initiative in the world. "At Definitive Healthcare, we strive to better our communities, create an open and inclusive workplace, and make the world a better place for all," said Robert Musslewhite, CEO of Definitive Healthcare. "We are proud to join the UN Global Compact to provide more transparency into our corporate sustainability and advance broader global efforts for protecting people and the environment."

09:07 EDT GitLab introduces TeamOps practice - GitLab introduced TeamOps, a results-focused management discipline, bringing precision and operation to how people work together. TeamOps is how GitLab scaled from a startup to a global public company in a decade. While GitLab has shared some of its practices in its handbook, through The Remote Playbook and partnering on the Coursera course on Remote Team Management, the TeamOps certification encompasses the actionable set of techniques and tools for making decisions in all work environments - remote, hybrid, and in-office. Supported by a set of Action Tenets with real-world examples for process, organizational structure and culture, TeamOps enables teams and companies to create an environment for better decision-making and improved execution.

09:05 EDT AnaptysBio, GSK-partnered agent JEMPERLI, cobolimab progress in separate trials - AnaptysBio (ANAB) announced that GSK's (GSK) study PERLA, a head-to-head trial of JEMPERLI vs. Keytruda in patients with metastatic non-squamous non-small cell lung cancer, met its primary endpoint of objective response rate, ORR, of dostarlimab plus chemotherapy versus pembrolizumab plus chemotherapy as assessed by blinded independent central review per RECIST v1.1. GSK expects to present full results from the PERLA trial, including the primary endpoint of ORR and the key secondary endpoint of progression-free survival, with results by programmed death ligand-1 expression subgroups, at an upcoming scientific meeting. The COSTAR Lung Phase 3 trial is a randomized, open label 3-arm trial comparing cobolimab plus dostarlimab plus docetaxel to dostarlimab plus docetaxel to docetaxel alone in patients with advanced NSCLC who have progressed on prior anti-PD-(L)1 therapy and chemotherapy. AnaptysBio expects to receive a $5 million milestone payment from GSK upon dosing of the first patient with cobolimab in the Phase 3 portion of COSTAR. JEMPERLI and cobolimab were discovered at AnaptysBio and licensed to TESARO, Inc., now a part of the GSK group of companies, under a Collaboration and Exclusive License Agreement signed in March 2014. "We are encouraged to see immuno-oncology molecules discovered at Anaptys delivering differentiated outcomes and advancing on multiple fronts by GSK," said Daniel Faga, interim president and chief executive officer of AnaptysBio. "We intend to leverage our strong capital position, which has been supported in part from the partial monetization of potential future royalty streams from this immuno-oncology portfolio, as we focus on the R&D of our novel immune cell modulator pipeline. This includes our two checkpoint agonists in clinical-stage development, rosnilimab, a PD-1 agonist, and ANB032, a BTLA-agonist, which act directly on cell types mediating disease pathology and have the potential to treat a broad range of autoimmune and inflammatory disorders."

09:03 EDT FDA advisors to discuss Cytokinetics' new drug application on December 13 - The Food and Drug Administration announced a forthcoming public advisory committee meeting of the Cardiovascular and Renal Drugs Advisory Committee to be held virtually on December 13. "The committee will discuss new drug application 216401, for omecamtiv mecarbil tablets, submitted by Cytokinetics, Inc. The proposed indication is to reduce the risk of cardiovascular death and heart failure events in patients with symptomatic chronic heart failure with reduced ejection fraction. The committee will discuss whether the phase 3 trial - GALACTIC-HF - establishes substantial evidence of effectiveness of omecamtiv mecarbil and whether the benefits of omecamtiv mecarbil outweigh the risks when used according to the applicant's proposed dosing regimen. FDA intends to make background material available to the public no later than 2 business days before the meeting," the agency's meeting notice stated. Reference Link

09:02 EDT IntercontinentalExchange expands wireless offering in Europe - Intercontinental Exchange announced it is expanding its wireless offering in Europe. ICE plans to offer market data and private bandwidth services over wireless between Bergamo, Frankfurt, London and within the London metro area. These new wireless networks are designed to provide market participants with a lower latency solution for connectivity between trading venues.

08:58 EDT Unsplash launches Unsplash+ subscription offering - Unsplash announced the launch of Unsplash+, an unlimited subscription providing access to an exclusive high-quality image library, with expanded legal protections for commercial use. Complementing the existing free Unsplash library of 4.2 million images, the Unsplash+ subscription provides an expanded service to creatives including unique imagery commissioned from the Unsplash community exclusively for Unsplash+ and content from the Getty Images historical archive. Unsplash search data will be used to identify areas of demand, and new imagery will be commissioned from within the Unsplash contributor community. Unsplash+ subscribers are guaranteed against model and location release, providing extra legal protection for their use in commercial applications.

08:49 EDT TLG Acquisition One continues search for business combination - The company said, "TLG Acquisition One announced that it is continuing to evaluate and pursue target companies for its initial business combination."

08:42 EDT New Frontier to cease real estate-related operations, enter oil shale extraction - Effective September 7, 2022, the Board of Directors of New Frontier Energy determined to cease real estate-related operations and adopted a new business plan to enter the oil shale extraction industry, with its business centered around a technology known as Resonance And Micronization System which it has sublicensed, on an exclusive basis, from United Energy, with the consent of the master license holder. The Company's CEO, Richard Edelson, is prepared to lead its charge into the oil shale extraction industry. "We believe the R.A.M.S. technology will revolutionize oil extraction from shale deposits. The R.A.M.S. technology is more economical, higher-yielding, energy-efficient, environmentally-friendly, rapidly-producing, and lower-maintenance than traditional methods of oil extraction from shale reserves," Mr. Edelson stated. "We are currently in the process of funding the manufacture of our first R.A.M.S. machine and have already begun implementing our sales strategies towards establishing a new frontier energy company. We will provide periodic updates to our shareholders, as progress is made," Mr. Edelson concluded.

08:38 EDT Evaxion Biotech appoints Per Norlen as new CEO - Evaxion Biotech announces that its new Chief Executive Officer, CEO, Per Norlen has joined the company on October 3rd. Dr. Norlen is a board-certified physician and associate professor with more than 20 years in the biotech sector, of which the last decade has been in executive leadership roles. Chairman of the board, Marianne Soegaard, says the new hire signals the next stage for the biotech company: "With Per at the steering wheel, we expect to bring our promising clinical and preclinical results to the next level. Evaxion is a profoundly innovative and talented company working tirelessly to save patients' lives. Per Norlen is joining the company as an experienced leader bringing the necessary expertise and competences to bring Evaxion from an innovative early stage to the next level. I look forward to having Per on board to help realize the vast potential from our clinical trials and create personalized therapies for cancer patients and patients suffering from other critical diseases."

08:37 EDT Nauticus Robotics announces additional contract award by U.S. DIU - Nauticus Robotics announced that it has been awarded a second multi-million dollar contract by the U.S. Defense Innovation Unit, DIU, for the development of an amphibious unmanned system also utilizing the Company's autonomous command and control software platform, ToolKITT. This development follows Nauticus' previous DIU award announcement on February 15, 2022, where ToolKITT is being utilized aboard the U.S. Navy's Defender Mission Specialist remotely operated vehicle systems to advance the subsea vehicle with more autonomous behaviors. "We are thrilled with the additional work the DIU and the U.S. Marine Corps have awarded us to continue providing leading maritime robotics and autonomy solutions to assist the warfighter," said Ed Tovar, Director of Business Development for Defense Systems at Nauticus. "We are humbled and honored to be doing our part to advance the usage of robotics and autonomous systems to remove servicemembers from harm's way."

08:36 EDT ToughBuilt secures distribution agreement with four major retailers in Germany - ToughBuilt Industries announced it has entered into four major retailers in Germany, representing tens of thousands of new end users across Europe, which accounted for a 35% share of the global hand tools market in 2022.1 A wide range of ToughBuilt SKUs will now be sold in stores and online by these new retailers: Friedrich Delker GmbH & Co.; Witte Metallwaren GmbH & Co.; Vageler & Christiansen GmbH; and Bernd Ulbricht Nachf. Michael Panosian, ToughBuilt CEO, commented, "These new partnerships in Germany offer the Company opportunities to capture further market share in a key EU Member state for ToughBuilt's global growth strategy and European expansion. Our distribution alliance with Witte, Bernd Ulbricht Nachf, and Delker will help to increase awareness of the ToughBuilt brand, cementing our reputation for quality and innovation worldwide."

08:36 EDT Fluent launches Purpose mobile app - Fluent announced the launch of Purpose, a mobile app focused on enabling consumer financial decisions and wellness through content and brand discovery. Ari Kassman, an entrepreneur with deep experience building technology companies, will join Fluent to help grow Purpose and develop other community-driven products. Purpose advances financial wellness, literacy, and education while saving consumers money. A complimentary addition to Fluent's existing media portfolio and rewarded discovery capabilities, Purpose matches consumers to brands through engaging content and relevant services that align to their lifestyle, budget and values.

08:34 EDT Daxor announces presentation on use of blood volume measurement - Daxor Corporation announces that a scientific session titled "Debating Volume-based versus Pressure-based Methods and Devices to Measure Congestion in Heart Failure" was held during the Heart Failure Society of America Annual Scientific Meeting on October 3rd, 2022, in Washington, DC. In a debate format before hundreds of clinicians both on-line and in-person, the panel compared pressure-based vs volume-based measures to assess volume overload in advanced heart failure patients. The session was moderated by Dr. Maria Rosa-Costanzo, Edward-Elmhurst Health and Dr. Marat Fudim, Duke University Health. Panel members included Dr Tamas Alexy, The University of Minnesota Medical School, Dr. Jeffrey Testani, Yale University Medical Center, Dr. Wayne Miller, Mayo Clinic, and Dr. Jenny Thibodeau, The University of Texas Southwestern Medical Center. The panel unanimously agreed that pressure and volume do not give the same clinical information.

08:33 EDT Radiant Logistics acquires operations of Cascade Enterprises of Minnesota - Radiant Logistics announced it has acquired the operations of Cascade Enterprises of Minnesota, a Minneapolis, Minnesota based, privately held company that has operated under the Company's Airgroup brand since 2007. The Company structured the transaction similar to its previous transactions, with a portion of the expected purchase price payable in subsequent periods based on the future performance of the acquired operations. On a post-closing basis, Cascade will continue to operate under the Airgroup brand through the remainder of 2022 and is expected to transition to the Radiant brand in early 2023 as Cascade is combined with existing Company owned operations in the Minneapolis area.

08:32 EDT Lazydays CFO Nick Tomashot to retire, Kelly Porter to succeed - Lazydays (LAZY) announced that Nick Tomashot will retire as CFO. Kelly Porter will assume the role of CFO on November 15. As part of the transition, Tomashot will remain with Lazydays as an advisor through the end of the year to help facilitate a smooth transition. Recently, Porter served as Corporate Controller and Vice President of FP&A at Lithia Motors (LAD), the largest automotive dealership group in the United States.

08:31 EDT Standard Motor acquires Kade Trading - Standard Motor Products announced that it has acquired 100% of the capital stock of Kade Trading, headquartered in Glinde, Germany. Founded in 2004, the company has operated across Europe as a supplier of mobile temperature control components to commercial vehicle, passenger car and specialty equipment markets, and has been a distributor of SMP products including electric compressors, hose assemblies and receiver dryers. The company generated approximately $6M in annual revenue during 2021. SMP will fund the acquisition in cash through borrowings under its revolving credit facility.

08:25 EDT First Solar completes sale of Japan project development platform to PAG - First Solar has completed the previously announced sale of a 293-megawatt DC utility-scale solar project development platform in Japan, to funds managed by PAG Real Assets. As part of the sale, the majority of First Solar project development employees in Japan have joined PAG. First Solar had also previously announced that it had entered into a definitive agreement pursuant to which PAG will acquire from First Solar its solar operations and maintenance platform with approximately 665 MWDC under management, in Japan. This transaction is expected to close in the second half of 2022, after obtaining regulatory approvals, the receipt of third-party consents and satisfying other customary closing conditions.

08:22 EDT Lyell Immunopharma to present preclinical data at SITC meeting - Lyell Immunopharma announced that five abstracts highlighting preclinical data on its product candidates and new genetic and epigenetic reprogramming technologies were accepted for presentation at the 37th Annual Meeting of the Society for Immunotherapy of Cancer taking place in Boston, Nov. 8 - Nov. 12, 2022. The new preclinical data includes an abstract describing the effects of c-Jun overexpression in combination with NR4A3 gene knockout to enhance the functional activity of ROR1 CAR T cells. The combination of these two genetic reprogramming technologies is being incorporated in Lyell's new product candidate, LYL119, a second generation investigational ROR1 targeting CAR T-cell therapy. All the presentations describe preclinical data demonstrating that genetic and epigenetic reprogramming can ameliorate T cell exhaustion and enhance stem-like qualities and potency of T cells in various modalities, including CAR T cells, tumor-infiltrating lymphocytes and T-cell receptor T cells. Two presentations will feature preclinical data from LYL845, Lyell's autologous TIL product candidate enhanced with Epi-R reprogramming technology, designed to create products with higher proportions of stem-like T cells. Lyell will also present preclinical data from its new genetic reprogramming technology designed to further limit T cell exhaustion, as well as data on its new epigenetic reprogramming technology, Stim-R, designed to generate a more potent T cell product by controlling delivery of activation molecules during T cell production.

08:19 EDT NORI begins monitoring environmental impacts of nodule collection system trials - The Metals Company announced that a multidisciplinary team of independent scientists from leading research institutions around the world and industry-leading contractors has commenced the next phase of an extensive environmental baseline and impact monitoring campaign in preparation for the Company's subsidiary NORI's ongoing pilot nodule collection system trials in the NORI-D area of the CCZ. Aboard a dedicated 103-meter-long monitoring vessel, scientists recently conducted pre-disturbance monitoring studies on a sub-section of the NORI-D exploration area to establish an environmental baseline before NORI's offshore strategic partner, Allseas, tests a system consisting of a prototype nodule collector at the seafloor connected to a riser system to bring nodules to the surface production vessel, Hidden Gem. Researchers use a range of high-tech equipment including bespoke tools developed by MIT, Scripps and Sequoia Scientific to characterise the behaviour of sediment plumes generated by the prototype collector on the seafloor; three dedicated moorings, current meters with acoustic modems to provide real-time seafloor current data and a large array of other specialized equipment which together represents the most extensive suite of instruments ever deployed for a single program in the deep ocean. The current campaign requires the coordination of 250 people across three vessels and also marks the initial trials of components of TMC's Adaptive Management System - being developed in partnership with Kongsberg Digital - which is expected to enable near-real-time 3D visualization in the deep sea and the simulation and analysis of the impacts of NORI's proposed operations at depths of 4kms. Having established a baseline of the NORI-D collector test area, scientists will proceed to monitor the environmental impacts of deployment and testing of the fully integrated nodule collection system. They will also undertake post-collection surveys to compare the status of the environment before and after the test. The data collected, together with many terabytes of existing baseline data collected by NORI throughout 16 offshore campaigns, will form the basis of NORI's application to the International Seabed Authority for an exploitation contract, which the Company expects to submit in the second half of 2023. Last month NORI announced that it received the ISA's recommendation to commence its pilot nodule collection system trials in the CCZ after its review of the Environmental Impact Statement and Environmental Monitoring and Management Plan. Trials of prototype nodule collectors have been successfully conducted by several ISA contractors including BGR and GSR in the recent years. NORI's tests will mark the first time an integrated nodule collection system - including nodule riser - has been trialled in the Clarion Clipperton Zone since the 1970s, when oil, gas, mining and industrial majors including Shell, BP, Rio Tinto, US Steel, INCO and Sumitomo successfully conducted pilot test work, collecting over 1,500 tons of nodules.

08:16 EDT Takeda Pharmaceutical announces FDA acceptance of Takhzyro sBLA - Takeda announced that the FDA has accepted a supplemental biologics license application, or sBLA, for the potential expanded use of Takhzyro for prophylaxis to prevent attacks of hereditary angioedema, or HAE, in pediatric patients two to 12 years of age. Currently, children with HAE under the age of six have no approved prophylaxis treatment.

08:15 EDT Alzamend Neuro adds healthy subject to dementia study on AL001 - Alzamend Neuro announced it has dosed its first healthy adult subject in its Phase IIA multiple ascending dose study of AL001 in subjects with dementia related to Alzheimer's. This blinded, placebo-controlled trial was initiated in May 2022 and is designed to evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions and determine the maximum tolerated dose. Alzamend is also pursuing AL001 for the treatment of bipolar disorder, MDD and PTSD. Based upon a recommendation by the U.S. Food and Drug Administration after its review and commentary on Alzamend's pre-investigational new drug briefing package for development of AL001 for bipolar disorder, MDD and PTSD, the ongoing clinical trial in Alzheimer's patients has been expanded. As the safety and tolerability of AL001 would need to be tested in healthy and elderly adults before Alzamend could initiate later-stage testing of AL001 for bipolar disorder, MDD and PTSD, the addition of healthy and elderly adults to the on-going AL001-02 clinical trial would expedite the timing of further clinical trials. Alzamend will test AL001 in four healthy adult and elderly adult cohorts of eight subjects under MAD conditions.

08:13 EDT Sema4 to provide whole genom sequencing for in newborn screening study - Sema4 announced it is a partner in the recently launched GUARDIAN study, a collaboration among premier non-profit, academic, government, and industry organizations. GUARDIAN is using whole genome sequencing to screen 100,000 newborns for more conditions than those currently included in standard newborn screening. The goals of the study are to drive earlier diagnosis and treatment to improve the health of the babies who participate, generate evidence to support the expansion of newborn screening through genomic sequencing, and characterize the prevalence and natural history of rare genetic conditions. The conditions GUARDIAN will screen for were identified based on select criteria, including: median age of onset before 5 years of age, greater than 90% probability of the condition developing based on the genetic result, effective treatments, and/or a well-established natural history of the condition. "We are relentlessly focused on accelerating the adoption and use of genomic information to impact the lives of as many people as possible, particularly newborns and children," said Katherine Stueland, President and CEO, Sema4. "As the first commercial laboratory to launch a rapid whole genome sequencing offering, to address broad unmet needs for early diagnosis, participation in this study is an important step forward for healthcare and in delivering on our goal to sequence once, analyze forever." More than 180 hospitals across the country currently use the Sema4 GeneDX rapid exome and genome offerings.

08:12 EDT Ocean Power awarded contract with DHS S&T on maritime domain awareness - Ocean Power Technologies has been selected for a $529,025 procurement by Amentum Services. OPT was awarded the procurement to assist Amentum in providing the Department of Defense Information Analysis Center with land, air, space, and port & coastal surveillance services in support of the U.S. Department of Homeland Security, DHS, Science & Technology Directorate, S&T. OPT's efforts under the Subcontract will include providing scientific hardware delivery, training, and integration services for DHS S&T Port and Coastal Surveillance projects. The P&CS project seeks to identify and integrate sensors and systems and share data suitable for the full spectrum of maritime operations. OPT will provide the required hardware, hardware deployment support, software, software deployment support, integration services, surveillance and telemetry data, and associated training in support of a PB3 PowerBuoy equipped with OPT's proprietary Maritime Domain Awareness solution. "We at OPT are proud to support DHS's mission to help secure the nation's coastlines," said Philipp Stratmann, President and Chief Executive Officer of OPT. "Ocean security is national security. We believe OPT's systems are well suited for long term maritime domain awareness deployments and have little to no adverse impact on the environment. DHS has thousands of miles of coastline to protect, and needs to develop detailed, sustainable information sources to execute on its mission to protect our country. Along with our partner, Amentum, we look forward to delivering new technology to DHS to help it achieve these goals."

08:11 EDT Agenus to present botensilimab data at SITC meeting - Agenus will present new data on its growing portfolio of clinical-stage immuno-oncology programs at the Society for Immunotherapy of Cancer 37th Annual Meeting, to be held November 8-12 in Boston, MA and virtually. New data on multiple expansion cohorts from the Phase 1 study of botensilimab in cold tumors will be presented at an oral plenary session on novel immunotherapies on Saturday, November 12th at 10:50am ET. Three additional presentations will include new data on the mechanisms underpinning botensilimab's differentiated and enhanced anti-tumor immunity and provide an overview of the Phase 2 trial in progress of AGEN1423, an anti-CD73-TGFbeta-trap bifunctional antibody in combination with balstilimab in advanced pancreatic cancer. Separately, Agenus announced that Dhan Chand, PhD, Head of Drug Discovery at Agenus was selected to present on the topic of enhanced CTLA-4 blockade at the SITC Targets for Cancer IO Deep Dive Series on Wednesday, October 5, from 2:00 pm - 4:00 pm ET. To register for the webinar, please visit the Educational and Scientific Programs section of the SITC website. Dr. Chand's selection to participate through a highly competitive process underscores his leadership and highlights the focus on botensilimab, as well as the field's appreciation for the important role CTLA-4 plays in anti-tumor immunity and the scientific contributions and understanding advanced by the team at Agenus.

08:09 EDT Worlds announces SCOTUS denied petition for writ on patent decision - Worlds (WDDD) has been notified that the Supreme Court of the U.S., SCOTUS, has denied its Petition for a writ of certiorari requesting that the SCOTUS review the March 10, 2022 decision of the U.S. Court of Appeals for the Federal Circuit and the adverse District Court decision from April 30, 2021. Those decisions ruled in favor of defendants Activision Blizzard (ATVI), Blizzard Entertainment, and Activision Publishing, and concluded that the patents asserted by Worlds were invalid as directed to abstract concepts. Worlds' request to have the SCOTUS accept its case as a companion case to the American Axle & Manufacturing v. Neapco Holding petition for writ of certiorari and to clarify the test applied by courts when deciding questions of patent eligibility were also denied, as was American Axle's request. However, there is a glimmer of hope on the patent front in that on October 4, one day after the Supreme Court rejected Worlds' request, the U.S. Solicitor General Elizabeth Prelogar recommended that the SCOTUS clarify how to determine whether or not an invention is worthy of patent protection. As reported in Bloomberg Law, the Solicitor General's Oct. 4 brief noted that The U.S. Court of Appeals for the Federal Circuit was wrong in finding that a method of manufacturing driveshafts to reduce vibrations was too abstract to be eligible for a patent, citing hundreds of years of patent law that patented similar inventions. The Solicitor General further stated that a step in the Supreme Court's test for eligibility has created uncertainty and urged the court to review the case. "We are disappointed in the ruling relating to Worlds, as we addressed constitutional issues of patent law and the ambiguity of the SCOTUS ruling on the Alice case," stated Thom Kidrin, CEO of Worlds Inc. "Unfortunately, the courts recently have shown they do not understand or value the innovations that often serve as the foundation for subsequent developments and are willing to strip patents granted by the USPTO experts from patent holders who incurred great expense and time to maintain them without even granting a hearing on appeal. We appreciate the extraordinary legal expertise of Susman & Godfrey and Davidson & Berquist during this 10-year legal journey." Kidrin added, "We are encouraged by the Solicitor General's request that SCOTUS review the American Axle case and hopefully provide clarity on patent eligibility that potentially could extend to our patents and millions of others." At this time, Worlds has exhausted all legal remedies in pursuing equity and fairness from infringement, having taken this matter to the Supreme Court to no avail. If the SCOTUS reviews the Axle case and its ruling changes the patent landscape, Worlds and its legal counsel will determine if there are any new options available.

08:05 EDT ManTech wins $115M U.S. Marine Corps intelligence systems contract - ManTech announced it has won a $115M contract with the U.S. Marine Corps Systems Command, Program Manager Intelligence Systems Program, PMIS, to research, analyze and engineer solutions that advance Marine Corps intelligence capabilities, drive the evolution of information systems and address cyber defense challenges. ManTech was awarded this contract under the Department of Defense, DoD, Information Analysis Center's, DoD IAC, Multiple Award Contract, MAC. This task order significantly expands ManTech's current support to test intelligence systems for survivability and vulnerability, conduct modeling and simulations and ensure solutions are reliable, maintainable and interoperable. ManTech will also develop autonomous systems; engage in research and development efforts; enhance knowledge management and information sharing; and support software, data and cybersecurity analysis.

08:05 EDT Eiger: FDA concluded authorization request 'unlikely to meet statutory criteria'

08:03 EDT Cerence, WFCO Partner to develop ai-powered RV cabin experience - Cerence announced a new partnership with WFCO Electronics to create a first-of-its kind digital cabin experience for recreational vehicles, RVs, as Cerence expands beyond the car to deliver AI solutions for all types of mobility. Together, Cerence and WFCO will create a voice-enabled interaction platform for RVs that will enhance safety, comfort and productivity on the road, creating an incredible experience for all RV passengers, regardless of whether they're driving or simply enjoying the journey. "Conversational AI has transformed many aspects of consumer mobility, enabling voice-powered interaction that simplifies drivers' interactions with their cars and improves their day-to-day journeys," said Stefan Ortmanns, CEO, Cerence. "We are thrilled to expand beyond the car to bring our proven innovation and technology leadership to a new area of mobility - RVs - and to partner with WFCO, a known, experienced player who is leading the way in RV innovation."

08:03 EDT Glass Lewis recommends Avalara investors reject sale to Vista Equity - Altair US, LLC, a pre-IPO angel investor in Avalara, Inc., noted that leading independent proxy advisory firm Glass, Lewis & Co. has recommended that Avalara shareholders vote AGAINST the company's proposed sale to Vista Equity Partners. In its report, Glass Lewis concluded: "We share Altair's view that the purchase price and implied valuation metrics of the transaction are uncompelling and, ultimately, inadequate when compared to the Company's historical valuation and the prices paid for other software companies in precedent transactions, including those selected by Goldman Sachs for its fairness opinion. We also take a dim view of the timing and other aspects of the process resulting in the transaction, including apparent conflicts of interest stemming from Goldman Sachs' longstanding relationship with Vista and certain Avalara directors' ties to Vista, for which the Avalara board took no action to attempt to mitigate. These concerns raise doubt, in our view, as to whether the transaction is the result of a truly robust and independent process and whether the interests of Avalara's shareholders and the primary objective of maximizing long-term shareholder value were the drivers of the process. All factors considered, we believe these concerns justify voting against the proposed transaction."

08:01 EDT Eiger BioPharmaceuticals won't submit EUA of peginterferon lambda to FDA - Eiger BioPharmaceuticals announced that, following feedback from the FDA, the company will not submit an emergency use authorization application of peginterferon lambda for the treatment of patients with mild-to-moderate COVID-19. Following Eiger's press release on September 6, 2022, the company submitted a pre-EUA meeting request to FDA, as well as additional morbidity and mortality outcomes data and analyses from the investigator-sponsored TOGETHER study. This included further statistical modeling and efficacy analyses of the study's primary and secondary endpoints and long-term follow-up data that the company believes continue to support the initial positive topline outcomes reported in March. In response, FDA denied the request for a pre-EUA meeting. Citing its concerns about the conduct of the TOGETHER study, FDA concluded that any authorization request based on these data is unlikely to meet the statutory criteria for issuance of an EUA in the current context of the pandemic. FDA suggested that, given peginterferon lambda's mechanism of action and the ongoing need for improved COVID-19 therapeutics, Eiger consider requesting an end-of-Phase 2 meeting to discuss a company-sponsored pivotal trial that could support an eventual Biologics License Application. Eiger is evaluating next steps for this program, in the U.S., as well as ex-U.S. emergency use authorization pathways and strategic options for continued development of peginterferon lambda for COVID-19 and other respiratory viral infections. "While we are disappointed that FDA will not consider an EUA application based on results generated from the TOGETHER study, we continue to have strong conviction in the potential of peginterferon lambda to confer a meaningful benefit for patients with COVID-19 and other respiratory viral infections," said David Cory, President and CEO, Eiger. "COVID-19 related deaths remain alarmingly high around the globe, including in the U.S. where, according to recent data from the Centers for Disease Control and Prevention, approximately 400 people die every day from this disease."

07:47 EDT ChargePoint announces global charging solution CP6000 - The company states: "ChargePoint announced the launch of the CP6000, ChargePoint's most flexible and serviceable global AC EV charging solution now available for vehicles of all types and sizes. Designed for the needs of the European market, the CP6000 is a complete charging solution for businesses and fleets that want to confidently and efficiently prepare for the future of electric mobility. Seamlessly integrating network software, station hardware and customer support, the CP6000 is designed to prepare businesses of all kinds across the globe for the next wave of EV adoption. The CP6000 is designed for scalability, flexibility, reliability, and a best-in-class driver experience, and offers reliable AC charging for 1 or 3 phase power at an adaptable output of 3.7 to 22kw per port. The CP6000 works seamlessly with ChargePoint's software platform, which offers real-time visibility into revenue, energy costs and driver details, complete control over pricing and driver access, and actionable reporting with over 35 pre-built charts and reports. ChargePoint's software also includes robust power management tools to automatically reduce energy costs, on-station video messages, and over 40 turnkey API integrations. The CP6000 is also fully compliant with Open Charge Point Protocol 2.01, the latest version of the open standard. Together, these features make it easy for customers to manage their charging program, reduce costs, improve utilisation, and prepare for the future."

07:38 EDT Marimed opens first medical cannabis dispensary in Maryland - MariMed announced the opening of its first dispensary in Maryland. Operated by the Company's wholly owned subsidiary, Kind Therapeutics USA, the 5,000 square foot, Panacea Wellness-branded dispensary features MariMed's portfolio of award-winning brands, including Nature's Heritage craft flower and concentrates, Betty's Eddies all-natural fruit chews, and Bubby's Baked soft baked goods. The dispensary is located at 2061 Generals Highway in Annapolis. More information about the dispensary is available at www.panaceawellness.com. In addition to Panacea Wellness Annapolis, under state regulations MariMed can own up to three additional dispensaries in Maryland. MariMed also currently owns or manages dispensaries in Illinois, Massachusetts, and Delaware, with additional sites under development in Illinois, Massachusetts, and Ohio. The Company continues to review accretive acquisitions in other legal cannabis states.

07:32 EDT Kraken Robotics receives $1.1M of contracts for AquaPix systems - Kraken Robotics announces contracts from two customers totaling $1.1M for its AquaPix Synthetic Aperture Sonar. Due to confidentiality reasons the customers cannot be named but deliveries will go to the UK and Singapore for integration onto small man portable Autonomous Underwater Vehicles.

07:31 EDT Exro Technologies signs product development agreement with equipment supplier - Exro Technologies announced that it has signed a new product development agreement with a major global equipment supplier. The partner remains under non-disclosure agreement, to be named at a future time. The agreement includes development and delivery of an engineered-to-order system incorporating Exro's proprietary Coil-Driver inverter for a new hybrid diesel-electric product for off-highway application, the company said in a statement.

07:24 EDT Target appoints Prat Vemana as Chief Digital and Product Officer - Target Corporation (TGT) announced the hire of Prat Vemana as executive vice president, Chief Digital and Product Officer. Vemana will join Target October 31 as a member of Target's leadership team, reporting to Chief Guest Experience Officer Cara Sylvester. In this role, he will oversee Target's digital business, including site merchandising, user experience, digital operations and product, and Target+, the retailer's growing online third-party marketplace. Additionally, Vemana will provide key support for Target's industry-leading product teams across the company by bringing a holistic view to the retailer's overall product strategy. Vemana joins Target from Kaiser Permanente, where he served as senior vice president and chief digital officer and led its enterprise product management and experience teams. During his time at the company, he advanced and accelerated its digital strategy by modernizing its platforms to migrate, deploy and manage applications with greater speed and agility. His work included implementing critical consumer experience enhancements like the redesign of the company's mobile app and launching same-day home delivery for its pharmacy business. Prior to joining Kaiser Permanente, Vemana held digital leadership positions at The Home Depot (HD) and Staples.

07:22 EDT Arch Biopartners adds Farris Smith as strategic advisor - Arch Biopartners (ACHFF) welcomed Mr. Farris Smith of Novo Nordisk Canada (NVO) as a Strategic Advisor for general corporate activity and business development of the Company's drug candidates. Farris Smith started his career with AP Moller in 2001 and joined Novo Nordisk in 2003 as head of Finance and Human Resources for the Arabian Gulf countries and has since held finance and operations positions of growing size and complexity throughout the global Novo Nordisk organization.

07:21 EDT Laser Photonics appoints Timothy Schick as CFO - Laser Photonics announced that Timothy Schick, CFA, has been appointed CFO of the Company, effective October 5, 2022. Schick joined the LPC in July 2022 as Vice President of Finance.

07:19 EDT Meta Materials, 911inform enter MOU for optoelectronics imaging solutions - 911inform announced that it has entered into a memorandum of understanding with Meta Materials. The combination of 911inform's security data platform and META's proprietary optoelectronics imaging technology will allow first responders and public safety agents to have better situational awareness when responding to incidents. META's electro-optics systems will enhance the capabilities of 911inform's platform by seamlessly integrating its proprietary wide-area motion imaging technology into 911inform's software. This will provide a new safety solution for law enforcement enabling critical communications for activities such as search and rescue, border and port security, large events, autonomous and vehicle traffic management.

07:16 EDT PharmaTher announces U.S. patent grant coverting ketamine for Parkinson's - PharmaTher Holdings announce that the United States Patent and Trademark Office granted US Patent No: 11,426,366, titled "Compositions and Methods for Treating Motor Disorders," which includes claims intended to cover ketamine in the potential treatment of Parkinson's Disease and motor disorders that cause involuntary or uncontrollable movement or actions of the body. On September 16, 2022, the Company announced efficacy and safety data from a Phase 1/2 clinical study of ketamine in the treatment of levodopa-induced dyskinesia in Parkinson's disease via a late-breaking abstract presentation, titled "Subanesthetic infusion of ketamine produces long-term reduction in levodopa-induced dyskinesia" at the MDS International Congress of Parkinson's Disease and Movement Disorders. The Phase 1/2 study was an open-label, dose-finding trial to test the safety, tolerability and pharmacokinetics of low-dose ketamine infusion to treat levodopa-induced dyskinesia in Parkinson's disease and to find an effective dose-range suitable for outpatient use. Two 5-hour low-dose ketamine infusions were given within a one-week period. The clinical study outcomes measured reduction of dyskinesia, captured with the Unified Dyskinesia Rating Scale and effects on parkinsonian symptoms, captured with the Unified Parkinson's Disease Rating Scale. The study enrolled 10 subjects with moderate to advanced Parkinson's disease with a target infusion rate being 0.30 mg/kg/hr. These data highlight that ketamine was safe, well-tolerated, and demonstrated that 100% of subjects treated with ketamine had a reduction in dyskinesias as measured by UDysRS indicating possible efficacy with a large effect size that warrants further investigation in a pivotal Phase 3 clinical study. UDysRS showed a clinically meaningful reduction from baseline through 3 months. The maximum tolerated infusion rate ranged from 0.20-0.30 mg/kg/hr which was dependent on either discomfort due to dissociation or hypertension. There were no adverse events post-infusion. Analyses of the patient diaries and the pharmacokinetic data are ongoing. Based on these data, the Company is preparing to engage the FDA to establish the next steps for a planned Phase 3 clinical study to allow for the Company's proprietary ketamine intravenous product, KETARX, approval for Parkinson's disease under the 505(b)(2) regulatory pathway. In August 2020, the Company entered into an exclusive license agreement with the University of Arizona to develop and commercialize the Patent.

07:11 EDT Eliem Therapeutics expects cash to fund operations into 2025 - The Company's unaudited cash, cash equivalents, and investments as of September 30, 2022 were $129.8 million, including receipt of $6.2 million in tax reimbursements within the quarter, which is expected to fund operations into 2025.

07:09 EDT Eliem initiates scaling up of two pre-candidates in Kv7 program - The Company's preclinical program targets the Kv7.2/3 potassium channel, a target that has clinical validation in pain and epilepsy. The Company has filed foundational intellectual property claims on its novel Kv7 compounds. In addition, while pursuing further lead evaluation, the Company has initiated the scaling up of two pre-candidates to enable the initiation of IND-enabling safety studies, expected in the first quarter of 2023, with Phase 1 studies planned to initiate in the first half of 2024. The Company's novel Kv7 compounds have demonstrated high potency and differentiated selectivity in electrophysiology assays, and in vivo anticonvulsant activity in the maximal electroshock seizure rat model. Preclinical data on the Kv7 compounds are planned to be reported later in the fourth quarter of 2022.

07:06 EDT Mindset Pharma selects lead clinical candidates for next gen drug portfolio - Mindset Pharma announced that after extensive preclinical screening studies, a lead psychedelic drug clinical candidate, MSP-2020, and a second back-up drug candidate, MSP-2003, have been selected from its Family 2 program in collaboration with The McQuade Center for Strategic Research and Development to advance to IND enabling studies. MSP-2020 and MSP-2003 are both novel and patentable compounds. They are covered under Mindset's United States Patent and Trademark Office patent number 17/387,864, titled "3-Pyrrolidine-Indole Derivatives as Serotonergic Psychedelic Agents for the Treatment of CNS Disorders." Mindset has received a notice of allowance from the USPTO for this application. In side-by-side comparisons to psilocybin and psilocin, the two drug candidates elicit in vitro and behavioral responses consistent with a stronger and shorter acting psychedelic effect than psilocybin and a significantly reduced half-life. "Through a world class scientific collaboration among the Mindset, MSRD and Otsuka Pharmaceuticals teams, Mindset has successfully moved its Family 2 program forward. After extensively screening multiple drug candidates in preclinical studies, we were able to identify not one, but two novel drug candidates to potentially advance to clinical human trials. We are delighted to have reached this major milestone in our program's development," said James Lanthier, CEO of Mindset Pharma. "These candidates, when compared to psilocin and psilocybin, showed the potential to be stronger and faster acting. The preclinical results continue to support our belief that next-generation psychedelic drug compounds have the potential to be superior treatment options for mental health. Our teams continue to advance our collaboration to bring this innovative therapeutic into first-in-human clinical development and ultimately to patients in medical need as rapidly as possible."

07:04 EDT Koru Medical enters SC Drug Development & Delivery Consortium - Koru Medical announced its membership in the Subcutaneous, or SC, Drug Development & Delivery Consortium, making it one of the first device companies to be added to the consortium.

07:04 EDT Laser Photonics announces Timothy Schick appointed CFO - Laser Photonics announced that Timothy Schick, CFA, has been appointed chief financial officer of the Company, effective October 5. "Tim brings a wealth of financial and operational experience in industrial markets to Laser Photonics that will benefit our company in the public markets," said Wayne Tupuola, chief executive officer of Laser Photonics. "As we execute our growth strategy over the next few years, I expect Tim to be a key contributor in driving both revenue and income growth, while keeping us in regulatory compliance."

07:03 EDT Genius Group to acquire Revealed Films for $10M - Genius Group announced that it has entered into an agreement to acquire Revealed Films, a media production company that specializes in multi-part documentaries. The transaction value is $10M with earnout and claw back payments in 2023, 2024 and 2025 that are contingent on meeting certain revenue and profitability criteria. The acquisition closed on October 4 and will enable Genius Group to enhance and supplement its always-evolving curriculum with high-quality entrepreneurial education videos. Revealed Films Inc. was founded in 2017 by award-winning filmmaker and television producer Jeff Hays and wellness and business expert Patrick Gentempo. The company launches three to four docu-series per year covering topics such as wealth building, health and nutrition, medical issues, religion, and political matters. Revealed Films will continue to operate as a separate entity.

07:01 EDT AerCap signs retention, lease agreements with SAS for 6 Airbus A320 aircraft - AerCap Holdings (AER) announced that it has signed agreements with SAS AB for the retention and lease extension of six Airbus (EADSY) A320 aircraft.

06:55 EDT Helen of Troy announces restructuring plan, sees annualized savings $75M-$85M - During the second quarter of fiscal 2023, the company focused on developing a global restructuring plan intended to expand operating margins through initiatives designed to improve efficiency and reduce costs, collectively referred to as "Project Pegasus". Project Pegasus includes initiatives to further optimize the Company's brand portfolio, streamline and simplify the organization, accelerate cost of goods savings projects, enhance the efficiency of its supply chain network, optimize its indirect spending, and improve its cash flow and working capital, as well as other activities. The Company anticipates these initiatives will create operating efficiencies, as well as provide a platform to fund future growth investments. The Company has the following expectations regarding Project Pegasus: Targeted annualized pre-tax operating profit improvements of approximately $75 million to $85 million, which the Company expects to begin in fiscal 2024 and be substantially achieved by the end of fiscal 2026. Estimated cadence of the recognition of the savings will be approximately 25% in fiscal 2024, approximately 50% in fiscal 2025 and approximately 25% in fiscal 2026. Total profit improvements to be realized approximately 60% through reduced cost of goods sold and 40% through lower SG&A. Total one-time pre-tax restructuring charges of approximately $85 million to $95 million over the duration of the plan and will primarily be comprised of severance and employee related costs, professional fees, contract termination costs, and other exit and disposal costs. All of the Company's operating segments and shared services will be impacted by the plan. In addition, the Company has implemented plans to reduce inventory levels, increase inventory turns, and improve cash flow and working capital. The Company expects improvements related to these initiatives to begin in the second half of fiscal 2023 and to continue into fiscal 2024.

06:04 EDT Patterson-UTI reports an average of 130 drilling rigs operating in September - Patterson-UTI reported that for the month of September, the company had an average of 130 drilling rigs operating in the United States. For the three months ended September 30, the company had an average of 128 drilling rigs operating in the United States.

05:54 EDT Blizzard 'making progress' on Overwatch 2 server issues - Aaron Keller, the game director of Overwatch 2, said via Twitter on Tuesday night: "We're steadily making progress on server issues and stability, as well as working through a second DDoS attack. We're all hands on deck and will continue to work throughout the night. Thank you for your patience - we'll share more info as it becomes available." Blizzard Entertainment (ATVI) president Mike Ybarra previously said that the game, which launched Tuesday, was experiencing a mass DDoS attack on its servers. The Fly notes that Activision Blizzard agreed to be acquired by Microsoft (MSFT) earlier this year. Reference Link

05:11 EDT Virgin Orbit announces latest rocket ready for flight - Virgin Orbit announced that its latest rocket has completed a full launch rehearsal and is now ready for flight. The window for the company's next launch, planned to be the first orbital space launch from the U.K., will be determined by the launch permitting regulatory process. The company's most recent rocket completed its full wet dress rehearsal on October 2, three months after the successful launch of its Straight Up mission. This reduction of nearly half of the time required between the company's previous missions, along with a significant decrease in the cost of manufacturing, continues the trend of the company's rapid evolution into a higher operational cadence.