Stockwinners Market Radar for November 11, 2022 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

17:18 EST Camber Energy announces letter from NYSE American - Camber Energy announced that on November 7, it received a letter from the NYSE American advising that the company's securities have been selling for a substantial period of time at a low price per share, which the Exchange determined to be a 30 day trading average price of less than 20c per share and, as a result, pursuant to Section1003(f)(v) of the NYSE American Company Guide, the company's continued listing is predicated on demonstrating sustained price improvement or effecting a reverse stock split of its common stock within a reasonable period of time, which the Exchange has determined to be no later than May 7, 2023. The company intends to closely monitor the price of its common stock and consider available options if its common stock does not trade at a consistent level likely to result in the company regaining compliance in a timely manner, including, if necessary, carrying out a reverse stock split.

16:46 EST Horizon Global announces receipt of continued listing standard from NYSE - Horizon Global "announced that it received a notice November 7, 2022 from the New York Stock Exchange indicating that the Company is no longer in compliance with Section 802.01C of the NYSE Listed Company Manual because the average closing price of the Company's common stock was less than $1.00 per share over a consecutive 30 trading-day period. The Company will notify the NYSE of its intent to cure the stock price deficiency and return to compliance with the continued listing standard. The Company can regain compliance at any time within the six-month cure period following receipt of the Notice, if, on the last trading day of any calendar month during the cure period, the Company's common stock has a closing share price of at least $1.00 and an average closing share price of at least $1.00 over the 30 trading-day period ending on the last trading day of that month. Horizon Global intends to closely monitor its stock price during the cure period and will, if necessary, consider available alternatives to cure the stock price non-compliance. The Company's common stock will continue to be listed and traded on the NYSE during the cure period, subject to the Company's compliance with other NYSE continued listing standards."

15:54 EST ShiftPixy trading halted, volatility trading pause

14:53 EST GlobalFoundries seeks annualized savings of $200M, cutting jobs - GlobalFoundries CFO David Reeder said earlier this week during the company's Q3 earnings call: "For the full year 2022, we now expect total gross CapEx to be between $3B and $3.3B, impacted primarily by the well-known delays in capital equipment. Despite the delay, we are on track to meet all of our material customer commitments for the year. As we look forward, we will be working closely with our customers and partnership, and we'll provide an update on our 2023 CapEx at the end of the year. While we have tightly managed expenses over the past year, we are nevertheless paying close attention to the uncertain macroeconomic conditions and to our customers' recent commentary regarding 2023 demand. We are working closely with our customers to monitor demand. And as [CEO Tom Caulfield] mentioned, we are proactively containing cost and accelerating previously planned productivity initiatives. Though we are still sizing these initiatives, we expect them to deliver annualized savings of approximately $200 million, the majority of which will be in OpEx. 2Neither these savings nor any related onetime charges are incorporated in today's guidance. We will provide you updates on these initiatives as appropriate." Bloomberg reported on Friday that the company informed its employees of impending job cuts, without disclosing when exactly the workforce reductions would occur. A GlobalFoundries spokesperson confirmed to Bloomberg that the company is making job cuts and enacting a hiring freeze, but declined to specify a number of jobs to be eliminated.

14:27 EST Alibaba reports 11.11 GMV 'in line with previous year' despite headwinds - Alibaba Group announced it concluded its 11.11 Global Shopping Festival, also known as Double 11 or Singles' Day, after generating gross merchandise value, or GMV, for brands "in line with last year's promotion" despite what it highlights as "economic and COVID-related headwinds." Last year, Alibaba said it generated GMV of RMB540.3B, or $84.54B at the time. "The festival climaxed on Friday with 17 million products on offer to over 1 billion consumers in China. 11.11 pre-sales kicked off on Oct. 24 at 8:00pm China Standard Time and sales ran from 8:00pm on Oct. 31 to Nov.10 11:59pm... Even in tough times, a presence in the world's second-largest retail market is a must and 290,000 brands took part in 11.11 over Alibaba's platforms, on par with last year," the company stated in a post to its blog. Reference Link

14:19 EST London Metal Exchange decides against Russian metal ban - The London Metal Exchange has decided against a ban on deliveries of new Russian metal after soliciting market feedback. "The LME will proceed with the status quo in respect of Russian metal," it said in a notice to members on Friday, according to Bloomberg. Aluminum stocks that have previously moved in reaction to reports that the LME was launching a discussion of a potential ban on new supplies of Russian metal include Alcoa (AA), Century Aluminum (CENX), Kaiser Aluminum (KALU), Constellium (CSTM) and Arconic (ARNC).

13:02 EST Baker Hughes reports U.S. rig count up 9 to 779 rigs - Baker Hughes reports that the U.S. rig count is up 9 from last week to 779 with oil rigs up 9 to 622, gas rigs unchanged at 155 and miscellaneous rigs unchanged at 2. The U.S. Rig Count is up 223 rigs from last year's count of 556 with oil rigs up 168, gas rigs up 53 and miscellaneous up 2. The U.S. Offshore Rig Count is up 3 to 17, up 2 year-over-year. The Canada Rig Count is down 9 from last week to 200, with oil rigs down 8 to 133, gas rigs down 1 to 67. The Canada Rig Count is up 32 rigs from last year's count of 168, with oil rigs up 32, gas rigs unchanged at 67.

12:57 EST Orion Energy reports Jenkins assumes role of CEO - Orion Energy Systems announced Michael Jenkins, the company's Executive Vice President and Chief Operating Officer, has officially assumed the role of Orion's Chief Executive Officer after the retirement of CEO Mike Altschaefl on November 10. Jenkins, Orion's new CEO, commented, "I'd like to thank Mike Altschaefl for his dedication and leadership to Orion over the past five years. He returned the business to financial strength, expanded our customer base and capabilities, and successfully guided Orion through the COVID-19 pandemic with care and empathy. Mr. Altschaefl leaves Orion a much stronger business as a result of his five years of leadership. We wish him all the best in his well-deserved retirement."

12:02 EST Candel Therapeutics presents data on CAN-2409 in combination with nivolumab - Candel Therapeutics announced presentation of late-breaking data from a phase 1 mechanistic clinical trial of CAN-2409, Candel's lead viral immunotherapy in development, in combination with nivolumab and standard of care treatment in patients with high-grade glioma. Data were presented at the 37th Annual Meeting of Society for Immunotherapy of Cancer. In the trial involving 35 evaluable patients, extensive biomarker analyses demonstrated that the combination of CAN-2409 and nivolumab resulted in a statistically significant expansion of activated tumor-fighting CD4+ and CD8+ T cells effector cells as well as decreased markers of exhaustion on effector cells. Proteomic analysis by OLINK revealed an increase in pro-inflammatory cytokines, including interferon-gamma, the chemokines CXCL9/10 and CXCL11, MCP-1, MCP-3, and granzyme A. Systemic immune activation was observed after the single administration of CAN-2409, prior to initiation of nivolumab. Median overall survival for patients with methylated MGMT promoter was 30.6 months for those who underwent gross total resection and 12.6 months for those who underwent sub-total resection. mOS for patients with unmethylated MGMT was 13.2 months and 15.9 months, respectively.

12:00 EST Algonquin Power falls -19.1% - Algonquin Power is down -19.1%, or -$2.19 to $9.31.

12:00 EST KE Holdings rises 18.9% - KE Holdings is up 18.9%, or $2.14 to $13.48.

12:00 EST Compass rises 51.0% - Compass is up 51.0%, or $1.24 to $3.67.

11:01 EST 8i Acquisition 2 Corp trading halted, volatility trading pause

10:20 EST Arkansas Public Service Commission approves Arkansas Driver Solar Project - The Arkansas Public Service Commission has approved the Entergy Arkansas Driver Solar Project, a new 250-megawatt AC renewable energy plant developed by Lightsource bp, which will be located on approximately 2,100 acres near Osceola in Mississippi County. Driver Solar will be the utility's largest solar facility, capable of generating enough energy to power more than 40,000 homes. The Driver Solar site is located along Arkansas Highway 61 near Carson Lake Road and Arkansas Highway 198, just south of Osceola, and will be situated adjacent to both the U. S. Steel's Big River Steel facility and the recently announced $3 billion expansion. Lightsource bp has completed development and permitting of the solar field and will build the facility under a build-transfer agreement with Entergy Arkansas. Driver Solar has an expected completion date in late 2024. Together with their joint venture partner bp, Lightsource bp has been delivering competitively priced, safe, and dependable, clean energy for businesses and communities in the United States and around the world since 2010. Lightsource bp was recently named world's largest solar developer by Mercom Capital Partners. Driver Solar is expected to provide between 350 and 400 jobs during the construction phase, utilizing the local workforce and subcontractors. Upon completion, Entergy Arkansas plans to employ outside services for site maintenance, such as land management and vegetation control, operations, office rent, team payroll and other items likely to have a local impact. Local businesses such as restaurants and stores may also benefit indirectly from the infusion of construction workers and activity during this time, company officials said.

10:00 EST Algonquin Power falls -14.9% - Algonquin Power is down -14.9%, or -$1.71 to $9.80.

10:00 EST Superior Industries rises 16.6% - Superior Industries is up 16.6%, or 71c to $5.00.

10:00 EST Doximity rises 20.7% - Doximity is up 20.7%, or $5.45 to $31.78.

09:47 EST Algonquin Power falls -13.2% - Algonquin Power is down -13.2%, or -$1.52 to $9.99.

09:47 EST Silvergate Capital falls -17.9% - Silvergate Capital is down -17.9%, or -$5.84 to $26.84.

09:47 EST KE Holdings rises 16.9% - KE Holdings is up 16.9%, or $1.92 to $13.26.

09:45 EST Carvana trading resumes

09:40 EST Carvana trading halted, volatility trading pause

09:38 EST AGBA Acquisition Ltd trading resumes

09:33 EST Toast Inc trading halted, volatility trading pause

09:32 EST Cartesian Growth Corp trading halted, volatility trading pause

09:25 EST M2 Capital to commence offer for Superior Industries at $5.85 per share - M2 Capital Partners announces that it will commence a tender offer for 100% of the outstanding shares of Superior Industries on November 11. The Offer is for $5.85 per Superior share - which represents a 40% premium - over the last six months average share price. The Offer is a 36% premium to the closing price of $4.29 per share on Thursday November 10. The aggregate equity purchase price, assuming all outstanding shares are tendered, is anticipated to be close to $160M. The transaction will be funded by cash.

09:15 EST PowerFleet forms partnership with ClickNow - Powerfleet has formed a partnership with ClickNow, a protection-as-a-service smart mobile application company. The partnership strengthens Powerfleet's focus to provide mission-critical solutions across business operations and expands existing safety capabilities to personal safety outside of a vehicle. The ClickNow mobile application in conjunction with Powerfleet's existing Unity platform, advanced modular solutions, and data science will continue to help Powerfleet customers save lives, time, and money.

09:04 EST Crypto Company says 'does not hold any cryptocurrencies on the books' - The Crypto Company released a statement from its CEO Ron Levy regarding recent events in the cryptocurrency industry. The statement reads as follows: "Due to the recent events in the world of cryptocurrency, I thought it would be pertinent to make a couple of distinctions, specifically related to the volatility of cryptocurrency and their limited effect on the blockchain industry as a whole - an industry in which TCC operates. First, I would like to reiterate that while blockchain is the underlying technology in which cryptocurrencies operate, the category of blockchain is much broader than just cryptocurrency and is not just based on cryptocurrencies, or the value of them. Blockchain has its own unique qualities that offer use cases in many, many industries that in no way hedge or depend on the values of traded cryptocurrencies. While the recent events of the crypto exchange FTX are creating much turbulence for cryptocurrencies, the Blockchain world continues to build and we believe that interest remains extremely strong. For instance, the demand for transparency, which blockchain represents, should increase given recent events. Second, I want to clarify that the business of The Crypto Company is not based on the value of cryptocurrencies, but rather on the delivery of education and consulting services to support development of the Blockchain industry to individuals, government agencies and enterprise businesses. As The Crypto Company recently announced, we have sold the majority of our Bitcoin mining rigs back to the parties that we originally purchased them from earlier this year. Our company does not hold any cryptocurrencies on the books, and our main line of business remains providing education and consulting through our 100% owned subsidiary, Blockchain Training Alliance. Due to this positioning, we believe The Crypto Company's growth trajectory and opportunities will further develop, no matter the outcome of the FTX situation. In fact, we are also paying attention to the possibility of new opportunities for The Crypto Company as the industry continues to change and adapt."

09:03 EST Armada extends deadline to consummate business combination with Rezolve - Armada Acquisition Corp. I announced that its Board has approved an automatic extension of the deadline for the Company to consummate the business combination with Rezolve Limited from November 17, 2022 to February 17, 2023. The Company's sponsor has deposited an additional $1.5M into the Company's Trust Account, as mandated by the terms of the Company's initial public offering which closed on November 17, 2021. Funds related to this extension were deposited on November 10, 2022. Additionally, the Company announced that it entered into a first amendment to their definitive business combination agreement with Rezolve Limited, a private limited liability company registered under the laws of England and Wales. The Boards of Directors of the Company and Rezolve have unanimously approved the amendment. The amendment extends the "outside date" under the business combination agreement to January 31, 2023, restructures the transaction so that Rezolve, rather than Rezolve Group Limited, a Cayman Islands exempted company, will be the listed entity upon closing, and modifies certain other provisions of the business combination agreement relating to the equity incentive plan to be adopted and the governing documents of Rezolve as a listed company. The business combination between the Company and Rezolve remains subject to the satisfaction of customary closing conditions, including the approval of the stockholders of the Company. "We are pleased by these extensions and the momentum in our business. Rezolve has been growing tremendously, and has made progress in a number of areas in 2022, including new distribution partnerships, new products and key personnel hires", said Dan Wagner, Chairman and CEO of Rezolve.

09:02 EST Immunocore presents new biomarker analysis for KIMMTRAK - Immunocore has presented new translational data on KIMMTRAK in patients with metastatic uveal melanoma at the Society for Immunotherapy of Cancer, SITC, 37th Annual Meeting. "We previously showed that some patients with radiographic progression can still have long survival on KIMMTRAK. In this analysis, we demonstrate that patients with longer survival retain expression of the antigen processing machinery required to ensure recognition by KIMMTRAK," said Koustubh Ranade, Ph.D., Head of Translational Medicine at Immunocore. "Downregulation of the antigen processing machinery is a known mechanism of resistance for all T cell therapies, including checkpoint inhibitors. We also demonstrate that gp100 protein remains unchanged even in patients who had disease progression." Biopsies were obtained in up to 18 metastatic uveal melanoma patients shortly after radiographic progression. These tumors were analyzed by immunohistochemistry or by RNAseq for full-length gp100, and for components of the antigen processing machinery including HLA-A, the HLA that presents the gp100 peptide recognized by KIMMTRAK. The expression of gp100 protein was unchanged relative to baseline and was not associated with overall survival. However, patients with longer OS, despite radiographic progression had higher expression of the APM, including HLA, and higher levels of T cells, compared to those with shorter OS. HLA downregulation has previously been reported as a mechanism of resistance to immune checkpoint inhibitors.

08:44 EST OncoSec's TAVO-EP meets secondary endpoint in advanced melanoma trial - OncoSec announced data from the Phase 2 KEYNOTE-695 clinical trial. This trial is evaluating TAVO, OncoSec's proprietary IL-12 encoding plasmid delivered by intratumoral electroporation - TAVO -EP -, in combination with pembrolizumab in patients with unresectable or metastatic melanoma who had progressed on immediate prior anti-PD-1 antibody therapy. The key secondary endpoint of KEYNOTE-695 was met. Investigator assessment showed a confirmed overall response rate - ORR - of 18.8%, which exceeds the pre-specified clinically meaningful ORR of greater than or equal to17%. Three patients achieved a complete response and 16 patients had a partial response. The disease control rate was 40.6%. Median overall survival was 22.7 months after a median follow-up period of 33.4 months. The combination therapy was generally well tolerated with no Grade 4/5 treatment-related adverse events. Grade 3 TRAEs were observed in 4.8% of patients. Top-line results of the primary endpoint of the KEYNOTE-695 trial, ORR are expected to be announced in 1Q23.

08:39 EST QuickLogic signs sales representation agreement with Japan's CHIP-gogo - QuickLogic has signed an embedded FPGA IP sales rep agreement with CHIP-gogo, based in Osaka, Japan. The new relationship has been put in place to match CHIP-gogo's broad semiconductor intellectual property and LSI design experience and customer relationships throughout Japan with QuickLogic's eFPGA technology. QuickLogic's eFPGA IP technology is enabling CHIP-gogo to assist their customers in integrating the IP into their own SoC designs

08:36 EST Bridgeline Digital announces partnership with Thanx Media - Bridgeline Digital announced its partnership with the US-based digital marketing agency Thanx Media. This partnership offers substantial revenue opportunities by combining Bridgeline's eCommerce-focused product suite with Thanx Media's expertise, proven by hundreds of successful projects in the B2B and B2C space including Fortune 500 customers such as PayPal, Target, and Ulta Beauty. "Bridgeline is excited to join forces with a top-tier agency partner," says Ari Kahn, CEO of Bridgeline. "We look forward to working with Thanx Media to generate revenue for our customers."

08:34 EST Navitas, Avnet Silica enter agreement for close collaboration - Navitas Semiconductor (NVTS) and Avnet Silica, an Avnet company (AVT), announced close cooperation between the two companies to grow the market in Europe for Navitas' advanced performance and highly power efficient GaNFast power ICs with GaNSense technology. The two companies will work closely together to deliver their combined complementary knowhow to bring a high level of support and expertise to customers across the EMEA region. Navitas' GaNFast power ICs with GaNSense technology integrate power, drive, and control capability, as well as autonomous protection and loss-less current sensing. "We chose to work with Avnet Silica as one of the premier experts in semiconductor distribution in Europe," said David Carroll, Senior Vice President of Worldwide Sales at Navitas. "The combination of our highly differentiated solutions together with Avnet Silica's expertise in technology markets will further support designers and engineers to meet ever more stringent efficiency and size requirements and regulations. With our highly experienced technical team and our European applications lab, together, we can support customers with the best possible solutions and fastest time-to-market."

08:33 EST Element Fleet announces renewal, TSX approval of Normal Course Issuer Bid - Element Fleet Management announced that the Toronto Stock Exchange has approved the Company's notice of intention to renew its normal course issuer bid for its issued and outstanding common shares in furtherance of its capital return strategy. Under the NCIB approved by the TSX, the Company may purchase on the open market up to 39,228,719 Common Shares, representing approximately 10% of the "public float" of the Common Shares, at its discretion during the period commencing on November 15, 2022 and ending on the earlier of November 14, 2023 and the completion of purchases under the NCIB. The actual number of Common Shares which may be purchased pursuant to the NCIB and the timing of such purchases will be determined by management of the Company, subject to applicable law and the rules of the TSX. Under the rules of the TSX, during the six months ended October 31, 2022, the average daily trading volume of the Common Shares on the TSX was 813,132, and, accordingly, daily purchases on the TSX pursuant to the NCIB will be limited to 203,283 Common Shares, other than purchases made pursuant to the block purchase exception. As of November 1, 2022, the Company had 393,055,672 Common Shares issued and outstanding and a "public float" of 392,287,191 Common Shares. Purchases made pursuant to the NCIB are expected to be made through the facilities of the TSX or through alternative trading systems in Canada, at prevailing market prices or as otherwise permitted. The NCIB will be funded using existing cash resources and any Common Shares repurchased by the Company under the NCIB will be cancelled. The Company believes that the NCIB is in the best interests of the Company and constitutes a desirable use of its funds. Under the current NCIB that commenced on November 15, 2021 and will end on November 14, 2022, the Company sought and obtained approval from the TSX to purchase up to 40,968,811 Common Shares for cancellation. For the period from commencement of the current NCIB up to and including October 31, 2022, the Company repurchased for cancellation an aggregate of 18,614,000 Common Shares for approximately $250 million, including commission, at a volume weighted average price of $13.43 per Common Share. The Company applies trade date accounting in determining the date on which the share repurchase is reflected in its consolidated financial statements. Trade date accounting is the date on which management commits the Company to purchase the Common Shares. Under the current NCIB, the Company has repurchased Common Shares over the TSX and over alternative trading systems in Canada. The Company will also enter into an automatic securities purchase plan with an independent designated broker in order to facilitate repurchases of Common Shares. The ASPP has been approved by the TSX and will be entered into effective as of or about November 11, 2022. Under the ASPP, the Company's independent designated broker may purchase Common Shares under the NCIB at times when the Company would ordinarily not be permitted to, due to its regular self-imposed blackout periods. Before the commencement of any particular internal trading black-out period, the Company may, but is not required to, instruct its independent designated broker to make purchases of Common Shares under the NCIB during the ensuing blackout period in accordance with the terms of the NCIB. Such purchases will be determined by the independent designated broker in its sole discretion based on parameters established by the Company prior to commencement of the applicable blackout period in accordance with the terms of the ASPP and applicable TSX rules. Outside of these blackout periods, Common Shares will continue to be purchasable by the Company at its discretion under the NCIB. The ASPP will terminate on the earliest of the date on which: the purchase limit specified in the ASPP has been reached, the purchase limit under the applicable NCIB has been reached, the Company terminates the ASPP in accordance with its terms, in which case the Company will issue a press release confirming such termination, and the applicable NCIB terminates.

08:16 EST Silo Pharma announces initial dosing in SP-26 study - Silo Pharma announced initial dosing in its IND-enabling study of SP-26, its novel time-released, topical formulation of ketamine. The objective of this safety evaluation study, conducted by Experimur, a Frontage Company, is to evaluate the tolerability of the SP-26 compound to establish a maximum tolerated dose. The new drug is intended to treat fibromyalgia, a chronic condition causing widespread musculoskeletal pain accompanied by memory issues, sleep problems and fatigue. Silo Pharma recently began working with a regulatory partner to prepare a pre-Investigational new drug package submission to the U.S. Food and Drug Administration. The Company intends to pursue the 505(b)(2) regulatory pathway for SP-26.

08:06 EST Fangdd Network announces board, committee changes - Fangdd Network announced that the Company's board of directors has appointed Zhen Xie as a director of the Company, the chairman of the Nominating and Corporate Governance Committee, a member of the Compensation Committee, and a member of the Audit Committee, to succeed Weiru Chen, who has resigned from these positions for personal reasons. These Board and committee changes became effective today. Zhen Xie is the founder and currently the chief executive officer of Shanghai MaiQin Information Technology Co.

08:05 EST Amneal Pharmaceuticals announces FDA acceptance of IPX203 NDA for review - Amneal Pharmaceuticals announced the FDA has accepted for review the new drug application, or NDA, for IPX203 for the treatment of Parkinson's disease, or PD. IPX203 is a novel, oral formulation of carbidopa/levodopa extended-release capsules.

08:04 EST ReWalk Robotics welcomes decision by BARMER on exoskeletons - ReWalk Robotics welcomed the decision by BARMER to accept the prior ruling from the state court that exoskeletons are considered as direct disability compensation and withdraw the pending case at the federal level shortly before the hearing. This outcome means that an eligible insured person with spinal cord injury has a legal basis for the supply of an exoskeleton as an orthopedic aid for direct disability compensation in Germany, ReWalk's largest market for exoskeletons. In the precedent ruling, the court determined that an exoskeleton device directly compensates for the loss of abilities for the spinal cord injured individual, such as the ability to stand, walk, and ascend or descend stairs and curbs. The definition of direct disability compensation applies to medical aids which replace failed and impaired bodily functions to the extent that the person using them is on par with people without disabilities. In this context, the provision of an advanced technical aid, such as an exoskeleton, can be provided to the medically eligible insured individual, regardless of any other medical aids that have previously been supplied.

08:03 EST Jowell Global expands logistics, distribution cooperation with ZTO Express - Jowell Global (JWEL) reported that it has expanded its cooperation with ZTO Express (ZTO). In November, 2022, JWEL and ZTO reached a customized warehouse distribution integration agreement which covers all logistic services for the Company, from warehousing management, express parcel distribution, express parcel packaging and express delivery, to be provided by ZTO Express. Since the parties started cooperation a year ago in 2021, JWEL has used warehouse, logistics network and automatic sorting system at ZTO's regional center for its order processing. The joint efforts of the two parties have reduced the amount of time goods in transit, costs and losses in turnover, significantly improved operating efficiency for JWEL. The newly negotiated cooperation agreement is expected to further simplify major logistical processes, streamlining the distribution cycle and promote the seamless integration of numerous business processes of the Company. Moving forward, JWEL seeks to continue promoting in-depth cooperation with ZTO, to achieve sustainable growth for both parties and encourage high-quality development of the e-commerce logistics. Furthermore, JWEL will continue seek and cooperate with high-quality business partners to explore and expand international products and resources for its customers while improving their experience and satisfaction.

08:01 EST Immix receives IRB approval to enroll pediatric patients in IMX-110 trial - Immix Biopharma announced that it has received Institutional Review Board, IRB, approval to enroll pediatric patients in its upcoming IMX-110 clinical trial. Enrolling pediatric patients in a clinical trial is a key requirement for FDA approval of a Priority Review Voucher, PRV. PRV holders can benefit from an expedited six-month review of a new drug application for any disease by the FDA. While their future value is uncertain, PRVs are transferable to other companies and have historically sold for $67 to $350 million according to a January 2020 report on drug development by the Government Accountability Office. "We are pursuing FDA approval of IMX-110 in pediatric rhabdomyosarcoma, a life-threatening cancer in children and the subject of our rare pediatric disease designation from FDA, as well as approval of IMX-110 to treat soft tissue sarcoma in adults," said Ilya Rachman, MD PhD, CEO of ImmixBio. "Our key opinion leaders at our 5 clinical trial sites are excited to bring IMX-110 to their adult and pediatric cancer patients."

07:43 EST Freyr Battery announces plan for Georgia Gigafactory - Freyr Battery has announced the selection and purchase of a site in Coweta County, Georgia for its planned Giga America battery plant. The company selected the Bridgeport Industrial Park site through a rigorous evaluation process based on key operational, logistical, and financial criteria, including the suitability of the site to co-locate modular upstream and downstream projects with the Giga America cell manufacturing facility. Freyr is planning to initiate detailed project engineering of Giga America in the coming months. The initial phase of Giga America is planned to be a cell production module of approximately 34 GWh based on the next-generation of 24M's U.S.-based SemiSolid production platform at an initial projected capital cost of $1.7B. The company is also evaluating value accretive upstream and downstream modules as well as additional cell production lines that are expected to bring total capital investments to more than $2.6B through 2029. Upon completion of all the contemplated construction phases, the Giga America complex is expected to be one of the largest battery cell manufacturing developments globally. In accordance with Freyr's ambitions to accelerate development of Giga America in parallel with the ongoing construction of Giga Arctic in Mo i Rana, Norway, the company is intensifying and broadening its financing efforts. The total package of financial incentives for Giga America includes robust assistance collectively provided by The State of Georgia and Coweta County in addition to the expected production tax credits associated with the recently passed Inflation Reduction Act. Additionally, Freyr intends to apply with the U.S. Department of Energy for packages that could include a grant and/or direct loans to assist with the development of Giga America.

07:38 EST Nouveau Monde provides update on Panasonic partnership - Nouveau Monde (NMG) provides a progress update on its business strategy in a quarter that saw the signing of a transformative commercial partnership with Panasonic (PCRFY) and Mitsui & Co., steady advancement of the company's Phase 2 projects, and commencement of active planning for its potential growth through the development of the Lac Gueret graphite property. NMG is reinforcing its governance and financial expertise with the nomination to its board of directors of Stephanie Anderson. In a market with tight supplies and increasingly stringent regulation on battery materials sourcing.

07:32 EST ARway announces trading on the Frankfurt Stock Exchange - ARway Corporation announces it is now listed to trade internationally on the Frankfurt Stock Exchange under the symbol: E65. Frankfurt Stock Exchange is the largest of the seven stock exchanges in Germany. On November 7, the Company announced that its common shares began trading in the USA on the OTC Pink Sheet Open Market under the stock symbol: ARWYF. To gain additional liquidity and appeal to a broader market the Company has applied to be listed in the United States on the OTCQB Venture Market by the OTC Markets Group Inc.

07:27 EST CureVac announces preliminary data from CV8102 expansion study - CureVac announced data from the Phase 1 expansion study of CV8102, the company's non-coding RNA candidate in oncology. Preliminary results from the completed Phase 1 expansion study in patients with PD-1 refractory melanoma confirm a robust safety profile of CV8102 as a single agent and in combination with anti-PD-1 antibodies. Preliminary efficacy was observed in a cohort of 30 patients treated in combination with anti-PD-1 antibodies, 40% of whom were pretreated with anti-CTLA-4 antibodies. As of June 15, in the anti-PD-1 combination cohort, five out of 30 patients experienced a partial response according to RECIST 1.1. Responses appeared durable for up to one year from the start of treatment. No objective responses were observed in the 10 patients of the single-agent cohort, 50% of whom were pretreated with anti-CTLA-4 antibodies. The data will be presented at the 37th Annual Meeting of the Society for Immunotherapy of Cancer, or SITC, held in Boston, Massachusetts. Extensive analysis of immune cell activation was performed to better understand CV8102's mobilization of the immune system against injected tumors as well as non-injected tumors. The data confirm that single agent or combination treatment, after the first dose, activated systemic pathways of immune response. Preliminary analysis of the tumor microenvironment in a subgroup of patients showed the positive outcome of increased infiltration of T cells, following intra-tumoral injection in 4 out of 8 and 10 out of 18 analyzed paired biopsy samples.

07:15 EST Focus Financial launches new credit facility to refinance Term Loan, Revolver - Focus Financial Partners announced that it is launching a new credit facility to refinance its existing First Lien Term Loan and Revolver due in 2024. Focus may also raise additional debt capital for general corporate purposes. Focus expects to close this transaction in the fourth quarter of 2022 and reaffirms its 3.5x to 4.5x net leverage ratio target.

07:09 EST ParkerVision files patent infringement complaints against MediaTek, Realtek - ParkerVision announced that it has filed new complaints in the Western District of Texas against Taiwanese global fabless semiconductor companies, MediaTek Incorporated and Realtek Semiconductor Corp. for the infringement of four of its U.S. patents. The complaints request jury trials to determine, among other items, the financial damages for the unauthorized use of ParkerVision's wireless patented technologies in semiconductor chips used in Smartphones, WiFi and Bluetooth devices.

07:07 EST Century Therapeutics presents preclinical data at SITC meeting - Century Therapeutics announced preclinical data from the Company's iPSC-based cell therapy platform were featured in two posters at the Society for Immunotherapy of Cancer, SITC, 37th Annual Meeting. Additionally, the Company provided pipeline program updates ahead of its virtual Research and Development Day. "Developing a best-in-class iPSC derived gamma delta CAR T cell platform is a top priority at Century and we are excited to share additional data supporting our strategic decision...," said Lalo Flores, Ph.D., Chief Executive Officer, Century Therapeutics. "Accordingly, we are pleased to announce the nomination of our newest pipeline program for solid tumors, CNTY-107, a Nectin-4 targeted gamma delta iT cell product candidate for which we expect to file an IND in 2025. Additionally, we continue to make progress with our iNK cell platform and are pleased to add to the preclinical data package supporting our iNK 3.0 platform, which shows enhanced functionality and illustrates the power and efficiencies of our platform. We look forward to discussing these updates later this morning during our virtual R&D Day." The Company today provided an update on its solid tumor strategy, including the nomination of its next pipeline program, CNTY-107, a Nectin-4 CAR gammadelta iT product candidate. The Company expects to file an Investigational New Drug Application in 2025 for Nectin-4+ cancers.

07:05 EST 36Kr Holdings enters strategic cooperation with FutureCar - 36Kr Holdings announced it has entered into a strategic cooperation with FutureCar, a North American media platform focusing on the automotive industry, particularly the New Energy Vehicle sector. Through authorized content sharing and mutual commercialization support, the cooperation with FutureCar will enable 36Kr to expand its business presence in the North American market and enhance its media coverage of the NEV industry and advanced automotive technologies worldwide. 36Kr has been exploring overseas business opportunities and has successfully extended its international business reach to Japan, Singapore, Indonesia, Europe, Australia and New Zealand. Notably, 36Kr's content has been included in Bloomberg Terminal and Dow Jones Factiva news feeds, attesting to the company's exceptional content quality and deep industry influence globally. Furthermore, FutureCar's roots in North America and deep expertise in the NEV industry will empower 36Kr to ride the wave of the fast-growing NEV market and the global intelligentization trend as the company's business grows. Collaboratively, the two parties will be well positioned to capture a broad array of development opportunities in the NEV industry and unleash greater commercialization potential.

07:04 EST Regeneron and Sanofi's Dupixent recommended for EU approval in prurigo nodularis - Regeneron (REGN) and Sanofi (SNY) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use - CHMP - has adopted a positive opinion, recommending the approval of Dupixent - dupilumab - in the European Union to treat adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy. The European Commission is expected to announce a final decision on the Dupixent application in the coming months. Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. In September 2022, Dupixent was approved by the FDA for the treatment of adult patients with prurigo nodularis, a chronic, debilitating skin disease with underlying type 2 inflammation and extreme itch. High-potency topical steroids are commonly prescribed but are associated with safety risks if used long-term. The positive CHMP opinion is supported by data from two Phase 3 trials showing Dupixent significantly reduced itch and skin lesions compared to placebo. The use of Dupixent in adults with moderate-to-severe prurigo nodularis is investigational in the EU and is not yet approved.

07:03 EST Bowman Consulting announces $10M share repurchase program - Bowman Consulting announced the authorization by its board of directors of a $10M share repurchase program. On November 10, the company's board of directors authorized a share repurchase program under which the company may repurchase up to $10M of Bowman's common stock.

07:01 EST Regeneron, Sanofi announce CHMP recommendation for Dupixent approval - Regeneron (REGN) and Sanofi (SNY) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP, has adopted a positive opinion, recommending the approval of Dupixent in the European Union, or EU, to treat adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy. The European Commission is expected to announce a final decision on the Dupixent application in the coming months. In September, Dupixent was approved by the FDA for the treatment of adult patients with prurigo nodularis.

06:47 EST BiondVax announces plans to effect ratio change - BiondVax announced that it plans to effect a ratio change of the company's American Depositary Shares to its non-traded ordinary shares from the current ratio of one ADS representing 40 ordinary shares to a new ratio of one ADS representing 400 ordinary shares. The ratio change will have the same effect as a reverse split of the existing ADSs of one new ADS for every ten old ADSs. The anticipated effective date for the ratio change is November 25, and the company's ADSs will continue to be traded on the Nasdaq Capital Market under the symbol with a new CUSIP Number 09073Q204. No action is required by holders of ADSs to effect the ratio change, as the change will be effected on the books of the ADS depositary. No fractional new ADSs will be issued in connection with the change in the ADS ratio. Instead, fractional entitlements to new ADSs will be aggregated and the depositary bank will attempt to sell them with the net cash proceeds from the sale of the fractional ADS entitlements to be distributed to the applicable ADS holders by the depositary bank.

06:35 EST Air Lease announces long-term lease placements for three new Boeing aircraft - Air Lease (AL) announced long-term lease placements for three new Boeing (BA) 787-9 aircraft with Air Astana, the national carrier of Kazakhstan. The aircraft are scheduled to deliver to Air Astana beginning in early 2025 through spring 2026 from ALC's order book with Boeing.

06:30 EST AstraZeneca announces availability of Alexion rare disease therapy in China - The company states: "AstraZeneca announced the availability of the first rare disease therapy from Alexion, AstraZeneca's Rare Disease group, in China. The availability of Soliris, eculizumab, for the treatment of paroxysmal nocturnal haemoglobinuria, PNH, and atypical haemolytic uraemic syndrome in adults and children in China represents a significant expansion of the company's global footprint in rare disease, following the acquisition of Alexion Pharmaceuticals, Inc. in 2021. In addition to announcing the availability of Soliris, AstraZeneca announced that the National Medicine Products Administration of China has accepted its supplementary application for Soliris for the treatment of adults with refractory generalised myasthenia gravis in patients who are anti-acetylcholine receptor antibody positive. The NMPA has also granted AstraZeneca approval to start ongoing, global clinical trials in China for investigational therapies being evaluated for the treatment of lupus nephritis, immunoglobulin A nephropathy and light chain amyloidosis." Reference Link

06:21 EST Sharps Technology, Sharps Technology announce new partnership - Nephron Pharmaceuticals and Sharps Technology announced a new partnership focused on developing and sharing best practices in innovative manufacturing, product development, customer support, and quality as Nephron prepares to launch the company's InjectEZ component of expansion.

05:36 EST GSK to limit U.S. use of ovarian cancer drug Zejula to some populations - GSK provided an update that at the request of the FDA it will restrict the second-line maintenance indication for Zejula to only the patient population with deleterious or suspected deleterious germline BRCA mutations. The US first-line indication of Zejula remains unchanged for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to platinum-based chemotherapy. This decision follows an FDA review of the final overall survival analysis of the ENGOT-OV16/NOVA phase III trial, which served as the basis for the approval of the second-line maintenance indication. In the final OS results from the NOVA trial, the secondary endpoint of OS demonstrated a hazard ratio of 1.06 in the non-gBRCAmut cohort. NOVA is a randomized, double-blind, placebo-controlled phase III trial of niraparib, an oral, once-daily poly polymerase inhibitor for the maintenance treatment of women with platinum-sensitive recurrent ovarian cancer. The primary endpoint of the NOVA study was progression-free survival, evaluated as two independently powered cohorts; results demonstrated the clinically meaningful and statistically significant benefit of niraparib in both cohorts and across the HRD subgroups in the non-gBRCAmut cohort. Secondary endpoints were safety and long-term exploratory endpoints, including overall survival. GSK is in ongoing discussions about these and other emerging OS data with health authorities worldwide. Reference Link

05:14 EST Albertsons announces Washington State Court delays TRO hearing date - Albertsons announced that the Washington State Court has postponed the date of the hearing regarding the temporary restraining order, or TRO, granted to the State of Washington. The TRO restrains the company from paying the previously announced $6.85 per share special dividend to stockholders of record as of the close of business on October 24. The hearing is scheduled to take place Wednesday, November 16 and Thursday, November 17, and the TRO remains in effect. Albertsons Cos. continues to believe that the claim brought by the State of Washington is meritless and provides no legal basis for canceling or postponing a dividend that has been duly and unanimously approved by Albertsons Cos.' fully informed board of directors.