Stockwinners Market Radar for November 07, 2022 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:07 EST Cathie Wood's ARK Investment bought 137.7K shares of Verve Therapeutics today

19:09 EST Macom CEO sells $3.23M in common stock - In a regulatory filing, Macom disclosed that its CEO Stephen Daly sold 50K shares of common stock on November 4th in a total transaction size of $3.23M.

18:41 EST Calumet Specialty Products completes transition of Steve Mawer to chairman - Calumet Specialty Products Partners announced that Steve Mawer will be transitioning from Executive Chairman of the Board to Chairman of the Board, effective January 1, 2023. This is a natural progression of the planned transition that began earlier this year. "Many thanks to Steve for the continuation of a seamless transition. We look forward to closely collaborating with Steve as we execute on our strategy and drive value for Calumet stakeholders," said Todd Borgmann, CEO.

18:02 EST Aris Water Solutions enters strategic agreement with Chevron, ConocoPhillips - Aris Water Solutions (ARIS) announced that it has entered into a strategic agreement with Chevron U.S.A. (CVX) and ConocoPhillips (COP) to develop and pilot technologies and processes to treat produced water for potential beneficial reuse opportunities. Aris, Chevron, and ConocoPhillips' goal is to develop cost effective and scalable methods of treating produced water to create a potential water source for industrial, commercial, and non-consumptive agricultural purposes. This Agreement demonstrates Chevron, ConocoPhillips, and Aris' continued commitment to responsible water management and leadership in working towards beneficial reuse of treated produced water in a water scarce region. Aris will lead the engineering, construction, and execution of the testing protocols and pilot projects while leveraging the combined technical expertise of Chevron and ConocoPhillips. The treated water will then be reused in a variety of ongoing research projects, including non-consumptive agriculture, low emission hydrogen production, and the direct air capture of atmospheric carbon dioxide. Aris, Chevron, and ConocoPhillips will work with appropriate regulators, with a goal to complete testing and performance evaluation of pilot technologies by the end of 2023.

17:36 EST Officer of BlackLine Mark Woodhams sold over $227K in company shares - Officer of BlackLine (BL) Mark Woodhams disclosed in a regulatory filing that he had sold 3,941 shares of company stock at $57.82 per share on November 7, for a total transaction amount of $227,869.

17:27 EST Ocuphire Pharma enters exclusive license agreement with FamyGen Life Sciences - Ocuphire Pharma (OCUP) announced it has concluded an exclusive license agreement with FamyGen Life Sciences for the development and commercialization of Nyxol across three indications in US, Europe, Japan, India, China and other global markets. In connection with its separately announced transaction with Famy, Viatris (VTRS), has agreed to commercialize Nyxol following each regulatory approval. Under the terms of the license agreement, Ocuphire will receive an upfront cash payment of $35M. Famy will fund Nyxol development through FDA approvals, that will be managed by Ocuphire, including clinical, manufacturing, and regulatory activities required for FDA approval of all three Nyxol indications, including Nyxol+Low-Dose Pilocarpine. With the upcoming NDA submission for the reversal of mydriasis indication this quarter, Ocuphire has the potential to receive a $10M milestone payment upon FDA approval later in 2023 and thereafter to receive additional regulatory milestones for presbyopia and night vision disturbances indications. In addition to funding Ocuphire's development of Nxyol in the U.S., Famy will undertake development in the non-US markets.

17:10 EST Fulcrum appoints new Chief Medical and new Chief Scientific officers - Fulcrum Therapeutics announced the appointment of Santiago Arroyo, as Chief Medical Officer, and Jeff W. Jacobs, as Chief Scientific Officer. Arroyo brings to Fulcrum nearly 20 years of biopharmaceutical industry experience, leading the clinical development of therapeutics across multiple disease areas. In his role as Chief Medical Officer at Momenta Pharmaceuticals, Dr. Arroyo led the clinical development of the company's broad portfolio of hematology, neurology, immunology, and materno-fetal therapeutics. Previously, he was the Chief Medical Officer of Boston Pharmaceuticals. Jacobs has more than 25 years of experience in drug discovery and target identification, and has led, co-led and mentored multiple discovery programs from concept stage through development candidate nomination, and from investigational new drug enabling studies through to pivotal clinical trials. Jacobs was most recently Chief Scientific Officer at Goldfinch Bio, where he led the research and discovery program to help build its portfolio of therapeutics for rare kidney diseases. Before Goldfinch, Jacobs held roles of increasing responsibilities at Ardelyx, and was promoted to Chief Scientific Officer.

17:01 EST Westport receives Nasdaq bid price compliance notification - Westport Fuel Systems announced that on November 3, 2022, it received written notice from The Nasdaq Stock Market LLC notifying it that it is currently not in compliance with the minimum bid price requirement set forth under Nasdaq Listing Rule 5550(a)(2). The Notification has no immediate impact on the listing of the Company's common shares, which will continue to trade on the Nasdaq. In accordance with applicable Nasdaq procedures, the Company has a period of 180 calendar days, or until May 2, 2023, to regain compliance with the Nasdaq Listing Rule. To regain compliance, the Company's ordinary shares must have a closing bid price of at least US$1.00 for a minimum of 10 consecutive business days. The Company intends to monitor the closing bid price of its common shares and may, if appropriate, consider implementing available options to regain compliance with the Nasdaq Listing Rule. Such options may include, but are not limited to, implementing a consolidation reverse share split of its outstanding common shares, to regain compliance with the minimum bid price requirement under the Nasdaq Listing Rules.

16:58 EST Asbury Automotive names Nathan Briesemeister as Chief Accounting Officer - Asbury Automotive announced that Nathan Briesemeister joined the Company as its Vice President, Chief Accounting Officer & Controller effective November 7, 2022.

16:48 EST Groupon still sees 15%-20% sustainable annual adjusted EBITA margins in 2023 - Says positioned to achieve $100M free cash flow starting in FY23. Sees CapEx and Other Expenses cash outflows totaling $40M-$55M in 2023.

16:46 EST Groupon sees Q4 consolidated billings roughly 51% of 2019 levels - Says continues to invest in marketing overall if company sees opportunities to drive attractive returns. Sees Q4 SG&A relatively in line with Q3. Sees Q4 consolidated local margins relatively in line with Q3. Sees generating free cash flow in Q4. Guidance taken from Q3 earnings presentation slides.

16:41 EST Investors Title Company declares $3.00 special dividend - Investors Title Company announced that the Company's Board of Directors declared a special cash dividend of $3.00 per share to shareholders of record on December 1, 2022, payable December 15, 2022. The special dividend will be funded through existing cash balances. The Board also declared a regular quarterly cash dividend of $.46 per share to shareholders of record December 1, 2022, payable on December 15, 2022.

16:40 EST Medtronic announces six-month results from SPYRAL HTN-ON MED trial - Medtronic announced the six-month results from the full cohort of the SPYRAL HTN-ON MED clinical trial. The data were presented as Late-Breaking Clinical Science at the American Heart Association Scientific Sessions 2022. With this news, Medtronic has submitted the final module of the Symplicity Spyral Premarket Approval package to the U.S. FDA for review and approval. Subjects who were prescribed antihypertensive medications and were treated with the Medtronic Symplicity Spyral Renal Denervation System had a statistically significant and clinically meaningful reduction in office-based systolic blood pressure, a key secondary endpoint, compared to subjects in the sham control group. However, in the primary endpoint, RDN did not demonstrate a statistically significant reduction in 24-hour ambulatory systolic blood pressure due to increased medications in the sham control group and the potential impacts of the Covid-19 pandemic on the clinical trial environment. The study also included Win Ratio, a pre-specified secondary endpoint that combines reduction in blood pressure with reduction in medication burden, which enables assessment of the overall beneficial effect of RDN. The Win Ratio demonstrated significance in favor of RDN versus a sham procedure. Finally, the study met its primary safety endpoint, with a low incidence of procedure-related and clinical adverse events.

16:38 EST CNX Resources, New Frontier announce partnership - CNX Resources and New Frontier Aerospace announced the companies have entered into an agreement, facilitated by Anew Climate, LLC, to utilize abated methane emissions to fuel net carbon neutral ground and flight tests of NFA's hypersonic vertical takeoff and landing aircraft. NFA is developing next generation aircraft that can deliver passengers and cargo anywhere on the planet ten times faster than today's jets, while CNX is a leader in capturing and processing methane that would have otherwise vented into the atmosphere, resulting in ultra-low carbon intensity natural gas. The two companies are working towards a path to next generation air travel that is carbon neutral well before the airline industry's 2050 target date. This vision endeavors to bring the world closer together with cargo and passenger flights to any destination on Earth in less than two hours while significantly improving the environmental impact of today's airliners.

16:37 EST Asur reports October passenger traffic up 29.9% vs. October of 2019 - Asur announced that passenger traffic for October 2022 reached a total of 5.4M passengers, 29.9% above the levels reported in October 2019. Compared to October 2019, passenger traffic increased by 40.7% in Colombia, 30.3% in Mexico and Puerto Rico by 11.1%. Passenger traffic growth in Colombia and Mexico was mainly driven by international traffic and in Puerto Rico by domestic traffic.

16:31 EST Southwest Gas names Robert Stefani as CFO - Southwest Gas Holdings announced the appointment of Robert Stefani as Senior Vice President and CFO, effective November 30. Stefani succeeds Gregory Peterson, who will retire on November 30. Stefani will report to President & CEO Karen Haller and will serve as a member of the Southwest Gas executive team. Stefani comes to the company from PECO Energy, where he was Senior Vice President, CFO and Treasurer, with responsibility for all financial activities including financial strategy, planning and analysis, operational finance, accounting, treasury, capital markets, strategic investment and risk management.

16:28 EST Arrowhead presents new Phase 2 data on cardiometabolic pipeline - Arrowhead Pharmaceuticals announced the presentation of new clinical data on its pipeline of investigational RNAi-based cardiometabolic medicines, ARO-APOC3, ARO-ANG3, and olpasiran, which is being developed by Amgen, in three late-breaking oral presentations at the American Heart Association (AHA) Scientific Sessions 2022, being held in Chicago. The company will also host a virtual analyst and investor event on November 9, 2022, at 10:00 am ET to discuss these data and Arrowhead's plans for future clinical development of ARO-APOC3 and ARO-ANG3. In the SHASTA-2 study in subjects with severe hypertriglyceridemia who had baseline triglycerides (TGs) of greater than 500 mg/dL, treatment with ARO-APOC3 at doses of 10 mg, 25 mg, and 50 mg all durably decreased APOC3 up to 87%, TGs up to 86%, non-HDL-C up to 45%, and increased HDL-C up to 99% through the week 16 timepoint. ARO-APOC3 has been well tolerated with treatment emergent adverse events reported to date that reflect the underlying comorbidities and conditions of the population under study. In the ARCHES-2 study in subjects with mixed dyslipidemia who had baseline median TGs of 226 mg/dL, treatment with ARO-ANG3 at doses of 50 mg, 100 mg, or 200 mg resulted in substantial reductions of ANGPTL3 up to 71% at week 8, TGs up to 59% at week 16, and LDL-C up to 32% at week 16. ARO-ANG3 was also associated with relative reduction in liver fat fraction at week 24, with no adverse events related to liver function test changes reported to date. ARO-ANG3 has been well tolerated with treatment emergent adverse events reported to date consistent with those expected in this patient population and with associated underlying comorbidities.

16:23 EST Invacare sees discontinuing production of respiratory products in Q4 - The company said it has begun to realize the benefit of improved access to key materials and components as a result of the increased financial flexibility from the financing transactions completed in 3Q22. On a consolidated basis, the company expects to see sequential constant currency net sales growth in 4Q22. Adjusted EBITDA is also anticipated to improve sequentially driven by revenue growth, higher gross profit attributable to the increased effectiveness of pricing actions, improved operational efficiencies, and restructuring benefits partially offset by continued higher input costs, and unfavorable foreign exchange. Through the first two months of 4Q22, Europe is on pace to deliver sequential constant currency net sales improvement and positive Adjusted EBITDA for the quarter. The company anticipates it will incur additional restructuring charges for North America in 4Q22 as it focuses on improving the profitability of this segment for the long-term.

16:21 EST Enova International raises share repurchase authorization to $150M - Enova International announced that its Board of Directors has authorized an increase to the company's common stock share repurchase program of up to $150M. This new authorization expires on December 31, 2023, and will go into effect when the existing $100M share repurchase authorization, which has approximately $19M remaining as of November 4, 2022, is exhausted.

16:20 EST Eagle Point Income Company raises quarterly dividend 14% to 16c per share - The Company has declared three separate distributions of $0.16 per share on its common stock payable on each of January 31, 2023, February 28, 2023 and March 31, 2023 to stockholders of record as of January 11, 2023, February 8, 2023 and March 13, 2023, respectively. This reflects an increase of 14% from the monthly distributions during the fourth quarter of 2022.

16:15 EST Sabra Health Care to expand relationship with Ensign, Avamere - Sabra Health Care (SBRA) announced that it will transition the 24-property portfolio previously leased to North American Health Care, Inc. to two of Sabra's existing tenants, The Ensign Group (ENSG) and the Avamere Family of Companies. After giving effect to this transition, Ensign will become one of Sabra's largest tenants, representing about 8% of Annualized Cash NOI, while Avamere will remain one of Sabra's largest tenants, also accounting for roughly 8% of Annualized Cash NOI. Sabra believes this transition represents a unique opportunity to improve the long-term value of this high-quality real estate portfolio, noting the enhanced credit profile that supports its rental income, highlighted by Ensign's corporate guaranty and $5 billion equity market capitalization. The transition of these facilities to Ensign operating companies and Avamere is expected to be completed by February 1, 2023 and remains subject to the completion of certain regulatory approvals and other closing conditions. Sabra expects to recognize a total of $14.7 million in revenue from these facilities during the fourth quarter through the end of the transition period, which approximates the rent Sabra would have received during this timeframe under the previous leases with North American.

16:14 EST Broadmark Realty Capital approves up to $75M share repurchase program - On November 7, 2022, the Company's Board of Directors approved a stock repurchase program authorizing the Company to repurchase up to $75.0 million of its common stock. Repurchases under the stock repurchase program may be made at management's discretion from time to time on the open market, in privately negotiated transactions or otherwise, in each case subject to compliance with all Securities and Exchange Commission rules and other legal requirements, and may be made in part under one or more Rule 10b5-1 plans, which permit stock repurchases at times when the Company might otherwise be precluded from doing so.

16:12 EST CrossFirst Bancshares gets regulatory approval to complete Farmers deal - CrossFirst Bankshares "announced receipt of regulatory approval from the Federal Deposit Insurance Corporation to complete the previously announced acquisition of Central Bancorp, Inc.'s bank subsidiary, Farmers & Stockmens Bank. F&S Bank currently has Central Bank & Trust branches in Denver and Colorado Springs and Farmers & Stockmens Bank branches in New Mexico. CrossFirst and Central expect to complete the merger on or about November 22, 2022, pending satisfaction or waiver of customary closing conditions set forth in the agreement."

16:10 EST Take-Two drops 10% to $97.85 after reducing bookings outlook

16:05 EST NanoString cuts total product and service revenue view for FY22 to $125M-$127M - Previous guidance was $140M-$150M. Revenue consensus is $143.26M. Sees FY22 adjusted EBITDA ($100M) vs. previous guidance of $75M-$85M.

15:11 EST SEC Chief Prashant Yerramalli departing Dec. 31, Amanda Fischer to replace - The Securities and Exchange Commission announced that Chief of Staff Prashant Yerramalli will leave the agency, effective Dec. 31. Amanda Fischer, currently Senior Counselor to Chair Gary Gensler, will be appointed Chief of Staff, effective upon Mr. Yerramalli's departure. "Amanda has been one of my most trusted advisers both since joining the SEC and during the Biden-Harris transition," Gensler added. "She is a remarkable talent with an exceptional background in policymaking from her time on Capitol Hill and at the agency. She has a firm grasp of complex regulatory issues in the capital markets. I'm delighted that she will be taking on this new role."Mr. Reference Link

14:18 EST Ryanair says Boeing needs to sort out challenges before new orders negotiation - During Ryanair's (RYAAY) earnings conference call, the company's CEO Michael O'Leary said that, "by the time we get to sometime in 2024, '25, we would like to be back at disclosures with Boeing [BA] on a new aircraft deal, but Boeing have to sort out their own kind of manufacturing challenges at the moment, and they're going to deliver what they've committed to first before we can actually start negotiating new aircraft orders with any bit of -- any sense of confidence that Boeing -- in the meantime, Airbus [EADSY] are marking up huge amounts of Boeing's market share... I have no doubt that once they sort out the current production problems, they will -- Boeing will want to recapture market share. And when that timing comes about, they know where -- we'll be there working with them, but only on pricing that makes it economic for us to continue to grow as Boeing's principle is kind of standard there -- here in Europe. "Boeing relationship, look, it's challenged at the moment. It is very difficult. But we've come to the realization, we have to work with Boeing. They are continuing -- they are challenged with production in Seattle. We accept now we won't get the 51 aircraft that they had originally contract delivered to us by the end of April. I think if we get to 40 or 45 aircraft by the end of June, that still allows us to maintain our ambitious traffic projection -- or traffic growth projections out to FY '24. I think over that period of time, the -- that their blockages -- production blockages which will work their way out of the system. We are back having discussions with them about the new aircraft," the executive added. "We are receiving some modest compensation from Boeing for these delivery delays, but really compensation is not that attractive to us... It is difficult because they are continuously failing to meet their delivery obligations to us. But I think we're at a stage where we recognize we have to work with Boeing as best we can."

14:06 EST Simmons First National director Dean Bass sells 27,100 common shares - In a regulatory filing, Simmons First National director Dean Bass disclosed the sale of 27,100 common shares of the company on November 3 at a price of $22.76 per share.

13:44 EST Notable companies reporting before tomorrow's open - Notable companies reporting before tomorrow's open, with earnings consensus, include Carlyle Group (CG), consensus $1.06... Norwegian Cruise Line (NCLH), consensus (70c)... Elanco (ELAN), consensus 16c... Coty (COTY), consensus 11c... Planet Fitness (PLNT), consensus 38c... SunPower (SPWR), consensus 8c... Workhorse Group (WKHS), consensus (12c).

13:27 EST Clarivate announces settlement agreement and release with OCLC - Clarivate announced that it has signed a settlement agreement and release with OCLC. "Clarivate continues to deny OCLCs allegations of wrong-doing and maintains that the issue lay between OCLC and its customers, who sought to co-create an efficient community platform for sharing of bibliographic records. Clarivate will not develop a record exchange system of MARC records that include records which OCLC has claimed are subject to its policy and contractual limitations. Clarivate will bear its own fees and costs," the company stated. Gordon Samson, Chief Product Officer at Clarivate added, "Clarivate will continue to support the goals of open research and data exchange - because we believe it is the best way to make the process of research and learning faster, more robust and more transparent. Regardless of business model, when scholarly information is easily accessible and shareable, the dots are easier to join, the connections are explicit, and collaborations are more natural and meaningful. The process of scientific discovery is faster, and it is easier to ensure research integrity and reproducibility. We know that navigating the transition to open research is important to our customers, and we remain committed to helping them make that transition as seamlessly as possible."

13:02 EST Mirum presents new data from Livmarli PFIC and ALGS studies - Mirum Pharmaceuticals presented new data from Livmarli oral solution studies, including two late-breaker presentations, at The Liver Meeting of the American Association for the Study of Liver Diseases taking place November 4-7, in Washington, D.C., the company announced. "The MARCH-PFIC data provides comprehensive evidence that LIVMARLI is a potentially meaningful treatment option for patients with progressive familial intrahepatic cholestasis, or PFIC. The statistically significant reduction in pruritus and serum bile acids, as well as improvements in bilirubin and growth, demonstrate a magnitude of treatment effect which exceeded expectations, suggesting higher doses not only improves response rates, but is also effective across PFIC types. We look forward to discussing these data with regulatory agencies soon. In addition, interim safety data in Alagille syndrome, or ALGS, underscores LIVMARLI's safety and tolerability profile in infants as young as two months of age. We are thrilled to expand the growing body of clinical evidence for LIVMARLI in both PFIC and ALGS and to present our late breaking data at the AASLD conference," said Pam Vig, PhD, head of R&D at Mirum.

12:47 EST Ubisoft says 'Prince of Persia' remake not cancelled - Ubisoft said that, while a new release date for the upcoming remake of "Prince of Persia: The Sands of Time" has not been set, it can confirm that the game is not cancelled and remains in development at Ubisoft Montreal. The post comes amid speculation that the remake, which was first announced in 2020, had been cancelled without a major announcement. Reference Link

12:34 EST AbbVie: Primary endpoint not met for mITT population in NOVA phase 2 trial - AbbVie announced new results from its exploratory NOVA phase 2 dose-ranging study evaluating the efficacy and safety of AGN-151607, a novel investigational neurotoxin for the prevention of postoperative atrial fibrillation in cardiac surgery patients. The primary endpoint of evaluating the occurrence of continuous atrial fibrillation greater than or equal to 30 seconds was not met for the modified intent-to-treat population; however, the data showed relative risk reduction in specific study populations, such as coronary artery bypass graft patients and patients aged 65 years and older. The results were presented today at the 2022 American Heart Association Scientific Sessions in Chicago, IL, USA, during the Late-Breaking Science session titled "Treating Atrial and Supraventricular Arrhythmias." Among the observed benefits, relative risk reduction was seen in certain subgroups; specifically, pre-specified CABG patients treated with 125 units of AGN-151607 received the greatest benefit with 29 percent relative risk reduction compared to placebo. In a post hoc analysis of CABG patients aged 65 years and older treated with 125 units of AGN-151607, the study found a greater risk reduction at 51 percent compared to placebo. Regarding rehospitalization within 30 days following discharge, patients treated with 125 units had lower rates of all-cause rehospitalization within 30 days compared to placebo. In addition, at the time of this analysis, more patients on 125 units were atrial fibrillation-free and anticoagulation-free versus placebo.

12:20 EST Amicus provides EU regulatory update for AT-GAA - Amicus Therapeutics provided an EU regulatory update for AT-GAA. Earlier this morning, the Committee for Medicinal Products for Human Use issued the agenda for their November meeting indicating possible oral explanations for miglustat and for cipaglucosidase alfa on November 9th. The company has now been informed that oral explanations will not take place as originally anticipated. The company continues to prepare for a CHMP opinion on AT-GAA as early as December 2022 and will assess any potential change in timelines.

12:18 EST Milestone Pharmaceuticals announces data from Phase 3 RAPID trial - Milestone Pharmaceuticals announced the presentation of new data from the Phase 3 RAPID clinical trial of etripamil, the Company's investigational calcium channel blocker, in patients with paroxysmal supraventricular tachycardia in the at-home setting. The presentation, titled "Self-administered Etripamil for Termination of Spontaneous Paroxysmal Supraventricular Tachycardia: Primary Analysis from the RAPID Study", was featured during a Late-Breaking Clinical Trials session at the American Heart Association Scientific Sessions 2022 held November 5-7 in Chicago, IL and virtually. Etripamil, a new chemical entity, is Milestone's lead investigational product. The multi-center, randomized, double-blind, placebo-controlled RAPID trial enrolled 706 patients across clinical sites in North America and Europe. Patients were randomized 1:1 to a nasal spray of etripamil or placebo, as prompted by symptoms of PSVT and without medical monitoring. To maximize the potential treatment effect of etripamil, patients who did not experience PSVT-symptom relief within 10 minutes were directed to self-administer a repeat dose of study drug. Pre- and post-drug ambulatory electrocardiographic data were independently adjudicated. The RAPID trial achieved its primary endpoint, with patients taking etripamil demonstrating a highly statistically significant and clinically meaningful difference in time to PSVT conversion compared to placebo. A Kaplan Meier analysis showed a statistically significantly greater proportion of patients who took etripamil converted within thirty minutes compared to placebo. By 90 minutes post-study drug administration, 80.6% of etripamil patients converted versus 60.7% of placebo patients and statistical significance was maintained throughout the five-hour observation window. Significant reductions in time to conversion in patients who took etripamil were evident early and persisted throughout the observation window of the study compared to placebo. The median time to conversion for patients in RAPID who received etripamil was 17.2 minutes compared to 53.3 minutes for patients on placebo. The safety and tolerability data from the RAPID trial continue to support the potential self-administration of etripamil, with findings consistent with those observed in prior trials. The most common randomized treatment emergent adverse events, which are adverse events that occurred within 24 hours of study drug administration, were related to the nasal administration site. Overall, the majority of RTEAEs were reported as mild to moderate. There were no reported serious AEs related to etripamil. Independently adjudicated ECG data show no cases of 2nd or 3rd degree heart block or significant pauses during at-home drug administration. To date, the Company's overall PSVT clinical program has resulted in more than 1,600 unique patient exposures to etripamil doses of greater than or equal to70 mg. In the RAPID study, patients who were treated with etripamil sought additional medical interventions less frequently and had fewer emergency department visits than patients in the placebo arm. These findings were consistent with the Company's previously completed Phase 3 NODE-301 study, in which patients who were treated with etripamil also sought additional medical interventions less frequently and saw a reduction in emergency department visits compared to patients in the placebo arm. Notably, analyses of pooled data from the NODE-301 and RAPID trials show that etripamil treatment provided a statistically significant reduction in both the use of additional medical interventions and visits to the emergency department. As previously communicated, the Company believes results from the RAPID trial together with the data from the already completed NODE-301 trial could fulfill the efficacy requirement for a New Drug Application submission for etripamil in patients with PSVT. The Company plans to submit an NDA application in mid-2023 pending agency feedback.

12:02 EST 1st Security Bank to acquire seven former Columbia Bank locations - FS Bancorp, the holding company for 1st Security Bank of Washington, announced that the Bank has entered into an agreement with Columbia Banking System, Inc. to purchase seven banking locations with approximately $510M in deposits and $76M in loans. The seven branch locations are in the communities of White Salmon and Goldendale, Washington, and Newport, Waldport, Ontario, Manzanita and Tillamook, Oregon. The purchase is subject to receiving regulatory approvals and customary closing conditions. Under the agreement, the Bank will assume certain liabilities, including checking, savings, IRAs and CDs belonging to households and small business customers who live in the local area. 1st Security Bank will be acquiring all seven retail locations, including their ATMs. Six branch properties are owned, and one branch property is leased with the Bank assuming the lease. The transaction is scheduled to close in February 2023.

12:00 EST ProShares UltraShort Bloomberg Natural Gas falls -17.7% - ProShares UltraShort Bloomberg Natural Gas is down -17.7%, or -$2.91 to $13.54.

12:00 EST Spirit AeroSystems rises 13.1% - Spirit AeroSystems is up 13.1%, or $3.08 to $26.51.

12:00 EST Tupperware Brands rises 18.8% - Tupperware Brands is up 18.8%, or 76c to $4.78.

11:06 EST Global Partners remains focused on driving 'profitable growth' across businesses - "We have executed well through the first nine months of the year and begin the final quarter of 2022 with strong operational and financial momentum," CEO Eric Slifka said. "While economic uncertainty associated with the inflationary environment merits a level of caution, we remain focused on leveraging our supply, marketing and terminalling assets to drive profitable growth across our businesses."

10:35 EST HLS Therapeutics highlights data on RESPECT-EPA study - HLS Therapeutics (HLTRF) highlighted key data presented at the American Heart Association 2022 Scientific Sessions relevant to VASCEPA related to RESPECT-EPA, A Randomized Trial for Evaluation in Secondary Prevention Efficacy of Combination Therapy - Statin and Eicosapentaenoic Acid. The RESPECT-EPA clinical trial is an independent study funded by the Japanese Heart Foundation. In 2005, the Japan EPA Lipid Intervention study first demonstrated a beneficial effect of highly purified EPA on cardiovascular outcomes in patients with or without coronary artery disease. In 2019, Amarin Corporation (AMRN) published the positive results of its double-blind placebo-controlled study REDUCE-IT in patients with cardiovascular risk and elevated TG levels. And now, RESPECT-EPA is the third study that demonstrated the value of highly purified EPA in reducing cardiovascular outcomes in patients with CAD. The late breaking data presented at AHA using 1.8 grams per day of purified EPA is consistent with the substantial body of evidence from the REDUCE-IT and JELIS trials, which showed that highly purified prescription EPA plus statin significantly reduces the risk of cardiovascular events in high- and very high-risk statin-treated patients. Importantly, the study achieved a borderline statistical significance with a 21.5% reduction in the primary composite endpoint measuring cardiovascular risk and achieved a statistically significant 26.6% reduction in the secondary composite endpoint of RESPECT-EPA. EPA level matters. In addition, a post-hoc analysis conducted by the investigators to control for attained EPA levels yielded a statistically significant 27.5% reduction in the primary endpoint. Other data presented at AHA 2022 support sustained low-density lipoprotein antioxidant effects for EPA in vitro compared with docosahexaenoic acid or mineral oil. The researchers concluded that the longer-term antioxidant actions of EPA may contribute to reduced events independent of placebo selection. Additional in vitro data presented at the meeting found that neither mineral oil nor corn oil affected rates of LDL oxidation, a central mechanism of atherosclerosis, even at high concentrations. HLS has in-licensed the exclusive rights to Vascepa for the Canadian market from Amarin.

10:15 EST GSK announces U.S. FDA approves fully liquid presentation of ROTARIX vaccine - GSK announced that the US Food and Drug Administration, FDA, has approved an oral-dosing applicator-only presentation of ROTARIX, which prevents rotavirus gastroenteritis caused by G1 and non-G1 types in infants. This new presentation formulation aims to make it more convenient for healthcare providers to prepare ROTARIX by removing the need to reconstitute the vaccine dose at the point of use. "Achievements like this are at the heart of our quest to reduce barriers to vaccination and remain a vital public health tool against the threat of preventable infectious diseases like gastroenteritis caused by rotavirus," said Temi Folaranmi, MD, Vice President US Medical and Clinical Affairs, Vaccines, GSK, "By creating a liquid formulation of ROTARIX that can be administered without additional mixing on site, we aim to give healthcare providers a more convenient option."

10:12 EST Triumph Group awarded business from U.S. mailine operator - Triumph Group announced that its Product Support business in Hot Springs, Arkansas has been awarded business from a major US mainline operator to perform shipset maintenance for Passenger Service Units, pilot and flight attendant seats for the 737NG aircraft that are going through interior modification. This business will extend over the next twelve months.

10:05 EST TMX Group to acquire Wall Street Horizon, terms not disclosed - TMX Group Limited announced it has agreed to acquire Boston-based Wall Street Horizon, a provider of global market-moving action and corporate event data. WSH provides traders, portfolio managers, academics and others an ever-expanding set of forward-looking and historical corporate event datasets, including earnings dates, dividend dates, options expiration dates, splits, spinoffs and a wide variety of investor-related conferences. Covering 9,000 publicly traded companies worldwide, the company offers more than 40 event types. Completion of this transaction is expected to close in Q4 and is subject to customary closing conditions. D.A. Davidson acted as exclusive financial and strategic advisor to WSH.

10:03 EST L.B. Foster, ACIPCO provideing coated pipe to Summit Carbon Solutions' pipeline - L.B. Foster Company announced that the Company's Protective Coatings business in Birmingham, Alabama, through its customer American Cast Iron Pipe Company, has been awarded an order for 2.5 million feet of 24-inch fusion bond epoxy coated pipe and an additional quantity of 24-inch abrasion resistant overcoat coated pipe for the Summit Carbon Solutions carbon capture, transportation, and storage project. The contract will represent one of the largest orders that the Birmingham line pipe coating facility has filled. The coated pipe will be used to build 2,000 miles of pipeline for Summit Carbon Solutions' project that is proposed to operate in South Dakota, North Dakota, Iowa, Minnesota, and Nebraska and capture, compress, and transport carbon dioxide through a pipeline from biorefineries and other industrial plants before being permanently sequestered in a safe storage facility in North Dakota. The pipeline will be constructed with high-strength steel and can transport up to 12 million tons of CO2 per year. The pipeline is expected to be operational in 2024.

10:00 EST ProShares UltraShort Bloomberg Natural Gas falls -12.6% - ProShares UltraShort Bloomberg Natural Gas is down -12.6%, or -$2.08 to $14.37.

10:00 EST Carvana falls -15.8% - Carvana is down -15.8%, or -$1.38 to $7.38.

10:00 EST Perfumania rises 11.0% - Perfumania is up 11.0%, or $1.00 to $10.18.

09:59 EST Aurora, Ryder to pilot on-site fleet maintenance for autonomous trucking - Aurora Innovation (AUR) and Ryder System, Inc. (R) announce a strategic collaboration to pilot on-site fleet maintenance. With Ryder technicians embedded at Aurora's terminal in South Dallas, the goal is to support the current pilot operations and prepare for commercial operation at scale. As part of the pilot, Ryder will embed skilled technicians to work alongside Aurora technicians at Aurora's South Dallas terminal to: Maintain Aurora's fleet of autonomous Class 8 tractors, including inspections, preventative maintenance, and repairs. Inspect and maintain trailers for pilot hauls and compliance with DOT standards. Collaborate with Aurora to minimize downtime and improve maintenance operations.

09:47 EST LSB Industries falls -10.1% - LSB Industries is down -10.1%, or -$1.68 to $14.91.

09:47 EST Ritchie Bros. falls -14.1% - Ritchie Bros. is down -14.1%, or -$8.79 to $53.53.

09:47 EST Shift4 Payments rises 10.6% - Shift4 Payments is up 10.6%, or $4.24 to $44.38.

09:45 EST 22nd Century highlights study on reduced nicotine content cigarettes - 22nd Century Group highlighted a recent study that found switching to 22nd Century's reduced nicotine content cigarettes "reduces toxicant exposure and increases smoking cessation without worsening mental health among smokers with mood or anxiety disorders." The study conclusively dispelled a common misconception that RNC's may exacerbate general health and mental health problems. The study also concluded that a national nicotine reduction policy for cigarettes will likely result in reduced nicotine absorption and likely result in greater smoking cessation from smokers with mood and anxiety disorders. The study examined adult smokers with a current or lifetime anxiety or unipolar mood disorder. The participants were randomly assigned to smoke conventional cigarettes or 22nd Century's RNC research cigarettes. Adult smokers who were assigned to smoke 22nd Century's RNC cigarettes had significantly lower cigarette consumption, lower cigarette dependence, lower plasma cotinine, and lower exhaled carbon-monoxide than smokers assigned to the conventional group. At the end of the study, despite having selected only participants not intending to stop smoking, those randomized to the group using 22nd Century's RNC cigarettes were more likely to have quit smoking. In related news, a webinar hosted by Mitchell Hamline School of Law's Public Health Law Center on November 3, 2022, featured FDA's Center for Tobacco Product Director Dr. Brian King publicly stating that the proposed menthol standard remains a key priority for him, the FDA, and CTP. The FDA is currently in the process of reviewing the comments they received as they move forward with the proposed rule. Dr. King also noted that the FDA remains committed to using its regulatory authority to protect public health and intends to finalize a nicotine standard for the maximum level of nicotine allowed in combusted tobacco products. The reduced nicotine rule is of high priority for the FDA as it has profound health benefits in terms of preventing initiation of smoking and promoting cessation for current smokers and a huge potential to have a positive impact on public health.

09:44 EST Mondelez doubles down on Cocoa Life program with total investment of $1B by 2030 - Mondelez International announces the next phase of its Cocoa Life program, backed by an additional $600M through 2030, for a total $1B investment since the start of the program, with the goal to increase cocoa volume at scale and work with about 300,000 farmers in the program by 2030. With this investment, Mondelez International aims to catalyze ground-breaking sector collaboration to help address systemic environmental and human rights challenges and improve cocoa farmer livelihoods. Mondelez International introduced Cocoa Life in 2012 to secure supply of more sustainable cocoa and establish an integrated approach striving to tackle the root causes of systemic issues in cocoa including farm productivity, farmer livelihoods, community development, and helping combat child labor and deforestation, together in one program. Ten years on, the program has reached critical scale with over 200,000 farmers in the program, $400M invested by the end of 2022 and measurable impact results including: Farmer net incomes have increased ~15% in Ghana and ~33% in Cote d'Ivoire; Cocoa yields are higher, with double-digit percentage increases in farmers earning a living income; 61% of Cocoa Life communities in West Africa covered with Child Labor Monitoring and Remediation Systems, with a goal to reach 100% by 2025. Key lessons from the past 10 years will allow Mondelez International to accelerate the Cocoa Life program and go further, faster, as more work remains to be done. These learnings include applying an integrated approach to help deliver impact at scale suited to the farmer, community, and landscape; focusing on enabling farmers to increase their income; and accelerating innovation in cocoa production supported by incentives designed to professionalize smallholder cocoa farming and introduce climate-resilient, new producing models.

09:38 EST Core Scientific produces 1,295 bitcoins in October - Core Scientific announced production and operational updates for October. As of month-end, the company operated approximately 243,000 ASIC servers for both colocation and self-mining, representing a total of 24.4 EH/s. The company's Georgia, Kentucky, North Carolina, and North Dakota data center facilities continue to operate at capacity. The company has completed 287 MW of its data center build out in Texas. Core Scientific's self-mining operations produced 1,295 bitcoins in October. As of October month end, the Company operates approximately 143,000 self-mining servers accounting for approximately 59% of the company's total fleet and representing a self-mining hashrate of 14.4 EH/s. In addition to its self-mining fleet, as of October 31, Core Scientific provided data center colocation services, technology and operating support for approximately 100,000 customer-owned ASIC servers. As of October month end, colocation services accounted for approximately 41% of the company's total fleet. During the month of October, the company sold 2,285 bitcoins at an average price of $19,639 per bitcoin for total proceeds of approximately $44.8M. As of October 31, the company held 62 bitcoins and approximately $32M in cash. In the month of October, the company powered down its Texas and other data center operations on several occasions. Curtailments in October totaled 5,125 megawatt hours. Core Scientific works with the communities and utility companies in which it operates to enhance electrical grid stability.

09:29 EST NLS Pharmaceutics provides OLE study update for Quilience - NLS Pharmaceutics announces an interim update from its Open Label Extension Study for Quilience in the treatment of narcolepsy. The OLE study offers patients completing the 4-week randomized, double blind Phase 2 trial for Quilience the option to receive the drug candidate for an additional 6 months as monotherapy on an open-label basis. Of the 60 patients who completed the randomized controlled Phase 2 trial, 52 patients elected to roll over into the OLE study. Excessive Daytime Sleepiness. For patients treated with Quilience in the randomized Phase 2 trial, excessive daytime sleepiness based on the Epworth Sleepiness Scale improved by an additional 1.8 points in the OLE study by the fourth month of treatment. At that timepoint, the mean ESS score for these patients reached 9.2, with lower scores denoting an improvement in the condition. Importantly, ESS scores of 10 or below are considered to be typical scores for patients without narcolepsy. As an extension of the 4-week randomized treatment period in the Phase 2 trial, these data indicate that maximum efficacy for EDS with Quilience is reached at approximately 3 months of treatment. Overall, the mean score for these patients declined by approximately 8.7 points from their baseline levels at the start of the randomized Phase 2 trial to month 3 in the OLE. For patients receiving placebo in the DB Phase 2 trial and rolling over to receive Quilience in the OLE study, EDS scores declined to levels comparable to those treated with Quilience in the randomized trial at Week 4. This effect was maintained through month 3 in the OLE study, with EDS scores just above the "normal" range. For patients diagnosed with cataplexy and treated with Quilience in the randomized Phase 2 trial, the mean number of weekly cataplexy episodes was approximately 8 at the end of the 4-week DB period, down from a baseline level of approximately 17.5 at the beginning of the trial. During the OLE study, mean weekly cataplexy episodes for these patients declined to 2.1, and remained relatively stable in the 2 to 4 range through week 12. For patients with cataplexy receiving placebo in the DB Phase 2 trial, the mean number of weekly cataplexy episodes was approximately 10.9 at the end of the 4-week double-blind period. During the OLE study, these patients, when treated with Quilience, were able to catch up to previously treated patients, achieving mean weekly cataplexy episodes of 2.7 at 8 weeks of treatment. This favorable effect was maintained for these patients in the 2-5 episodes per week range through week 12. Notably, there were patients diagnosed with Narcolepsy Type I who achieved zero weekly cataplexy episodes in the OLE study, with some of those maintaining this effect through week 12 and beyond.

09:27 EST Cummins to manufacture electrolyzer system for Ontario green hydrogen facility - Cummins Inc. will design and manufacture the electrolyzer system for the first 20-megawatt green hydrogen facility in the Canadian province of Ontario. Atura Power selected Cummins for the project for its Niagara Hydrogen Centre in Niagara Falls, Ontario. The electrolyzer system will split water into oxygen and carbon-free "green" hydrogen, which will then be available to industrial customers for immediate consumption. Cummins' work to expand the supply of low- and no-carbon hydrogen is just one way the company is taking a leadership role on the world's climate challenges. Cummins is also bringing to market new low- and no-carbon power technologies and working to reduce the carbon emissions from its traditional products such as internal combustion engines. Detailed design work on the electrolyzer system for the Niagara Hydrogen Centre and system integration is underway, with plans to bring the centre online in early 2024.

09:24 EST enVVeno Medical passes preliminary FDA safety review for VenoValve study - enVVeno Medical announced that the Company has passed a preliminary safety review by the U.S. Food and Drug Administration for the first twenty patients enrolled in the ongoing SAVVE U.S. pivotal study for the VenoValve. The FDA had requested that enVVeno submit preliminary safety data at thirty days post VenoValve implantation for the first twenty patients enrolled in the study. The preliminary safety data submitted by the Company included one device related and two procedure related adverse events. After review by the FDA, the study was cleared to continue without modification or interruption. The Company currently has thirty-three patients enrolled in the trial and based upon the current pace of enrollment, expects to be fully enrolled by the end of the second quarter of 2023. With $42.7 million of cash and investments reported at the end of the third quarter of 2022, the Company has sufficient cash to sustain operations through the end of 2024, including past the expected release of thirty day primary safety and one hundred eighty day primary efficacy endpoint data from the study. The SAVVE Trial is a prospective, non-blinded, single arm, multi-center study of 75 CVI patients. The trial's primary safety endpoint is based on the number of major adverse events at 30 days post implantation. MAEs are defined as mortality, deep wound infection, major bleeding, ipsilateral deep vein thrombosis or pulmonary embolism.

09:22 EST Crown Holdings adopts limited duration shareholder rights plan - Crown Holdings has unanimously adopted a limited duration shareholder rights plan following the Board's evaluation and consultation with its advisors. Under the Rights Plan, the rights will be exercisable if an entity, person or group acquires beneficial ownership of 10% or more of Crown's outstanding common stock. If a shareholder's beneficial ownership of Crown's common shares as of the effective date of the Rights Plan and associated dividend declaration is at or above 10%, that shareholder's existing ownership percentage would be grandfathered, but the rights would become exercisable if at any time after this announcement the shareholder increases its ownership percentage by 0.5% or more. In the event that the rights become exercisable due to the ownership threshold being crossed, each right will entitle its holder to purchase at the exercise price, common stock having a market value equal to twice the exercise price. Pursuant to the Rights Plan, Crown will issue one right for each outstanding share of Crown common stock to shareholders of record on the close of business on November 17, 2022. The Rights Plan is effective immediately and will expire on November 6, 2023.

09:21 EST WBA to invest $3.5B to support VillageMD acquisition of Summit Healt-CityMD - VillageMD announced it has entered a definitive agreement to acquire Summit Health-CityMD, a provider of primary, specialty and urgent care. The transaction is valued at approximately $8.9B with investments from Walgreens Boots Alliance (WBA) and an affiliate of Evernorth, a subsidiary of Cigna Corporation (CI). WBA will invest $3.5B through an even mix of debt and equity to support the acquisition of Summit Health-CityMD, which drives meaningful synergies and accelerates WBA's path to profitability for its U.S. Healthcare segment. WBA will remain the largest and consolidating shareholder of VillageMD with approximately 53% ownership. The company expects to maintain an investment grade rating. As a result of the transaction, WBA is raising its U.S. Healthcare fiscal year FY25 sales goal to $14.5B to $16B , from $11B to $12B previously. WBA's U.S. Healthcare segment is now expected to achieve positive adjusted EBITDA by the end of FY23. Assuming a January 1, 2023 closing date, WBA is raising the U.S. Healthcare adjusted EBITDA target for fiscal year FY23 to down $50M to up $25M, from down $220M-$240M million previously. The transaction will be slightly accretive to WBA adjusted EPS in FY23, and accretive by 7c to 11c in FY24 and increasing thereafter. The transaction is subject to the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and other customary closing conditions. It is expected to close in the first quarter of calendar 2023.

09:18 EST Silicom secures new design win and initial $2M order for its Edge platform - Silicom has secured a new Design Win and initial $2+M order from an existing customer for its new Edge product: a platform based on Intel's new CPU. Per the customer request, deliveries of this initial order are planned to begin during 2Q23. The Silicom platform supports the range of Edge Networking use cases, from SD-WAN and SASE to Enhanced Internet, dedicated telco routers and more. The reference design for the new Intel CPU was developed by Silicom during the past year, and Silicom is the first-to-market with a platform based on it.

09:16 EST Veru jumps 32% after FDA posts briefing documents for meeting of advisors - In pre-market trading, Veru shares are up $3.28, or 32%, to $13.63 after the FDA posted the briefing documents for the Pulmonary-Allergy Drugs Advisory Committee Meeting being held on November 9 to discuss Veru's request for Emergency Use Authorization 113, for VERU-111, an oral capsule, for treatment of SARS-CoV-2 infection in hospitalized patients with moderate to severe COVID-19 infection who are at high risk for ARDS. The FDA is convening this Advisory Committee meeting to discuss whether the submitted data support the Emergency Use Authorization of VERU-111 for the treatment of hospitalized adults with moderate to severe COVID-19 who are at high risk fo acute respiratory distress syndrome, or ARDS, the document notes. "The FDA Review team acknowledges that Study 902 met its prespecified primary endpoint of all-cause mortality at Day 60. We also note that the VERU-111 program is quite small in size compared to other therapeutic programs for patients hospitalized with COVID-19. As detailed in the briefing document, our review has identified a number of uncertainties with the data, which we raise in the context of this small trial in critically ill patients," the document prepared by the FDA staff for the advisors stated. Reference Link

09:14 EST BCB Bancorp appoints Blake to board of directors - BCB Bancorp announced that its Board of Directors has appointed Ryan Blake, MBA, Senior Vice President, SVP, and Chief Operating Officer, COO, since 2021, to serve as a member on its board. Blake is an experienced banking and financial services executive that has grown in successive roles within BCB for the past 14 years.

09:11 EST Vyant Bio teams up with IRSF to host local viewing party - Vyant Bio announced that, with the International Rett Syndrome Foundation, IRSF, the Company will host a local viewing party for the 3rd Annual Raise a Glass for Rett Gala, at the Ida and Cecil Green University of California, San Diego Faculty Club in San Diego, CA. "We are delighted to partner with the International Rett Syndrome Foundation to host the local viewing party for the Raise a Glass for Rett Gala in San Diego," commented Jay Roberts, CEO of Vyant Bio. "This event promises to be an evening of education, awareness, fine food and drink, and an opportunity to support Rett families around the world. We have invited patients and their families, along with care providers, doctors, and scientists, to join us as we look forward to inspiring updates on science and research advancements in the fight against Rett Syndrome."

09:10 EST Huadi International announces pricing of $25M registered direct offering - Huadi International Group announced that it has entered into a securities purchase agreement with two institutional investors for a registered direct offering of $25 million of its ordinary shares, before payment of commissions and expenses. The offering is expected to close on or about November 9, 2022, subject to the satisfaction of customary closing conditions. The offering consists of the sale of 1 million ordinary shares in a registered direct offering, at a purchase price of $25.00 per ordinary share. Univest Securities, LLC is acting as the exclusive placement agent for this offering.

09:07 EST Columbia Banking agrees to sell seven branches to 1st Security - Columbia Banking System (COLB) announced that Columbia has entered into a purchase and assumption agreement to sell seven branches in Washington and Oregon to 1st Security Bank of Washington, the wholly-owned subsidiary of FS Bancorp (FSBW). Columbia and 1st Security will provide additional information to customers of the branches to be divested. The agreement includes approximately $510M in deposits and approximately $76M in loans as well as owned real estate and fixed assets associated with the branches. The branches are being divested to satisfy commitments to the U.S. Department of Justice, DOJ, in connection with Columbia Banking System's pending merger with Umpqua Holdings Corporation. The sale is expected to be completed in the first quarter of 2023, subject to regulatory approvals and other closing conditions, including the consummation of Columbia Banking System's merger with Umpqua.

09:05 EST Columbia Banking to sell seven branches to FS Bancorp's 1st Security Bank - Columbia Banking (COLB) has entered into a purchase and assumption agreement to sell seven branches in Washington and Oregon to 1st Security Bank of Washington, the wholly-owned subsidiary of FS Bancorp (FSBW). Columbia and 1st Security will provide additional information to customers of the branches to be divested. The agreement includes approximately $510M in deposits and approximately $76M in loans as well as owned real estate and fixed assets associated with the branches. The branches are being divested to satisfy commitments to the Department of Justice in connection with Columbia Banking System's pending merger with Umpqua Holdings (UMPQ). The sale is expected to be completed in 1Q23, subject to regulatory approvals and other closing conditions, including the consummation of Columbia Banking System's merger with Umpqua. All employees will be retained by 1st Security and all branches will remain in operation after the sale.

09:02 EST LPL Financial: Artiea Capital Management team joins RIA, custodial platforms - LPL Financial LLC announced that the team at Artiea Capital Management has joined LPL Financial's broker-dealer, RIA and custodial platforms. They reported having served approximately $630 million in advisory, brokerage and retirement assets, and join LPL from Wells Fargo Financial Advisors Network. Based in Westlake Village, Calif., Artiea Capital Management was formed in 2011 with a mission to partner with clients to help them more confidently navigate their financial path and amplify the joys of a life well-lived. Partner financial advisors Paul Artof, CFP, Joel Chitiea, Jason Artof CFP, and Jamie Wood CRPC lead the team, which also includes wealth advisor Cassandra Mettlen, paraplanner Scott Davis, senior registered client associate Rosalyn Weihe and client services associate Melinda Heydon.

08:58 EST Nkarta presents data on NK cell based combination therapies - Nkarta announced the presentation of two preclinical data abstracts focused on its natural killer, NK, cell pipeline and proprietary manufacturing technology at the Society for Immunotherapy of Cancer, SITC, 37th Annual Meeting and Pre-Conference Programs. "Our presentations at this year's SITC meeting illustrate the inherent power and potential of donor-derived NK cells," said James Trager, PhD, Chief Scientific Officer of Nkarta. "Nkarta's research team has shown that our manufacturing platform technology can expand NK cells by well over a billion-fold, while maintaining their integrity and potency. These findings could prospectively allow us to derive our CAR NK products from a very limited set of stringently selected donors. In a second study, the team has also further built on the considerable potency of our CD19-directed CAR NK candidate, NKX019."

08:57 EST SciSparc announces interim results from Phase IIa trial of SCI-110 - SciSparc announced positive interim results from its Phase IIa trial of SCI-110 in patients with Alzheimer's Disease and agitation. Agitation manifests in the course of AD progression in almost all affected patients, increasing patients' suffering and burden of care. This Phase IIa clinical trial is an open label study, which includes 20 patients diagnosed with AD and agitation, to evaluate the safety, tolerability and efficacy trends of twice daily oral administration of SCI-110. At the interim analysis, the study met its primary endpoints of safety, including non-treatment related adverse events and drop out patients from the study; specifically, SCI-110 did not cause delirium, oversedation, hypotension or falls even in the highest dose tested. In general, the study medication was well tolerated with no negative response to the treatment observed during the duration of the study. "We are pleased that SCI-110 is showing clinically meaningful results and may provide a potential treatment option for Alzheimer's patients with agitation," said Adi Zuloff-Shani, PhD, Chief Technology Officer of SciSparc. "These results further support our efforts to reimagine medicine in this challenging area and reach this underserved patient population."

08:55 EST NLS Pharmaceutics announces interim update from Quilience OLE study - NLS Pharmaceutics announced an interim update from its open label extension, or OLE, study for Quilience in the treatment of narcolepsy. The OLE study offers patients completing the four-week randomized, double blind Phase 2 trial for Quilience the option to receive the drug candidate for an additional six months as monotherapy on an open-label basis. Of the 60 patients who completed the randomized controlled Phase 2 trial, 52 patients elected to roll over into the OLE study. For patients treated with Quilience in the randomized Phase 2 trial, excessive daytime sleepiness, or EDS, based on the Epworth Sleepiness Scale, or ESS, improved by an additional 1.8 points in the OLE study by the fourth month of treatment. At that timepoint, the mean ESS score for these patients reached 9.2, with lower scores denoting an improvement in the condition. Importantly, ESS scores of 10 or below are considered to be typical scores for patients without narcolepsy. As an extension of the 4-week randomized treatment period in the Phase 2 trial, these data indicate that maximum efficacy for EDS with Quilience is reached at approximately 3 months of treatment. Overall, the mean score for these patients declined by approximately 8.7 points from their baseline levels at the start of the randomized Phase 2 trial to month 3 in the OLE.For patients receiving placebo in the DB Phase 2 trial and rolling over to receive Quilience in the OLE study, EDS scores declined to levels comparable to those treated with Quilience in the randomized trial at Week 4. This effect was maintained through month 3 in the OLE study, with EDS scores just above the "normal" range. For patients diagnosed with cataplexy and treated with Quilience in the randomized Phase 2 trial, the mean number of weekly cataplexy episodes was approximately 8 at the end of the four-week DB period, down from a baseline level of approximately 17.5 at the beginning of the trial. During the OLE study, mean weekly cataplexy episodes for these patients declined to 2.1, and remained relatively stable in the 2 to 4 range through week 12. For patients with cataplexy receiving placebo in the DB Phase 2 trial, the mean number of weekly cataplexy episodes was approximately 10.9 at the end of the 4-week double-blind period. During the OLE study, these patients, when treated with Quilience, were able to catch up to previously treated patients, achieving mean weekly cataplexy episodes of 2.7 at 8 weeks of treatment. This favorable effect was maintained for these patients in the 2-5 episodes per week range through week 12. Notably, there were patients diagnosed with Narcolepsy Type I who achieved zero weekly cataplexy episodes in the OLE study, with some of those maintaining this effect through week 12 and beyond.

08:52 EST FDA requests thirty-day safety data from SAVVE study - "This annual letter to shareholders will summarize a handful of our accomplishments from the past year as well as focus your attention on some of the important milestones that we have planned for 2023. As we recently announced, as part of the FDA approval of our IDE for the SAVVE U.S. pivotal trial for the VenoValve, the FDA requested that we submit thirty-day safety data on the first twenty patients enrolled in the SAVVE study. It is not unusual for the FDA to request to closely monitor safety data for an initial group of patients in a study for a first-in-class device such as the VenoValve. The FDA reviewed the initial safety data and the SAVVE study is continuing without modification or interruption. We are proud of the safety profile that we are creating for the VenoValve. In addition to being extremely important to us, patient safety will be a significant part of the FDA approval process and an important consideration for doctors when considering whether to adopt the VenoValve. We continue to make good progress in the VenoValve U.S. pivotal trial and are on track to release initial safety data in the second half of 2023. When evaluating patient safety, it is important to understand the current risk profile for patients with deep venous Chronic Venous Insufficiency . In addition to CVI having a debilitating impact on CVI sufferers, the disease can also be fatal. According to the U.S. Centers for Disease Control and Prevention approximately 60,000 to 100,000 Americans die each year from a blood clot in the deep vein system or a pulmonary embolism.."

08:51 EST ABVC BioPharma receives notice of allowance of patent for ABV-1504 - ABVC Biopharma announced that on October 20, 2022, it received a Notice of Allowance for ABV-1504 from the US Patent and Trademark Office. The patent, entitled "Polygala Extract for the Treatment of Major Depressive Disorder," outlines a method for treating major depressive disorder by oral administration of a composition, ABV-1504, containing Radix Polygalae. The polygala extract, designated PDC-1421, is the key active ingredient in ABV-1504 which was orally administered to healthy volunteers and proved to be safe and well-tolerated for a daily dose from 380 mg to 3800 mg. The study indicated that the drug can be administered chronically over at least 25 days with the daily dose administered once per day, twice per day, or three times per day, wherein each dose contains from 380 mg to 760 mg of the botanical extraction. In addition to the United States, the patent was also filed in China, Taiwan and under the Patent Cooperation Treaty. The PCT patent application was published on January 27, 2022, and subsequently was filed in Japan, Australia and with the European Patent Office.

08:48 EST Scynexis announces publication of review article on ibrexafungerp - SCYNEXIS announced the publication of a review article highlighting the potential use of ibrexafungerp as a novel treatment option for invasive infections caused by opportunistic molds in the Journal of Fungi. "This review in the Journal of Fungi showcases ibrexafungerp as a potential treatment for invasive mold infections, which are a growing threat to public health, particularly in immunocompromised patients," said David Angulo, M.D., Chief Medical Officer of SCYNEXIS and lead author of the publication. "The importance of this topic is further underscored by the recently published WHO fungal priority pathogens list to guide research, development and public health action, validating the need for new antifungal agents such as ibrexafungerp, which has shown a spectrum of activity against most of the fungal pathogens in this priority list."

08:47 EST Xenon Pharmaceuticals appoints DiFabio as CLO, Corporate Secretary - Xenon Pharmaceuticals announced the appointment of Andrea DiFabio as Chief Legal Officer, CLO, and Corporate Secretary, effective immediately. DiFabio will provide strategic leadership and oversight of the planning and execution for Xenon's legal function on a global basis. Prior to joining Xenon, DiFabio was the Chief Legal & Administrative Officer and Corporate Secretary at Repertoire Immune Medicines from March 2020 to October 2022.

08:45 EST iKena Oncology expects cash to fund operations through mid-2024 - As of September 30, 2022, Ikena had $174.4 million in cash, cash equivalents, and marketable securities, and believes this will be sufficient to meet its operating requirements through mid-2024. Net cash used in operating activities was $17.2 million for the three months ended September 30, 2022, as compared to $18.0 million of cash used in operating activities for the same period in 2021.

08:45 EST Blue Apron in 'active' discussions with Sanberg regarding funds

08:43 EST Affimed provides data update from Phase 1/2a trials of AFM24 - Affimed announced data updates from two phase 1/2a trials with AFM24, the company's tetravalent, bispecific innate cell engager, in patients with solid tumors. AFM24 binds both EGFR on tumor cells and CD16A on natural killer cells and macrophages, thereby facilitating the killing of EGFR-positive tumor cells. Abstracts for the upcoming data presentations at the 37th Annual Meeting of the Society for Immunotherapy of Cancer were published today. Poster Number 729: Targeting Epidermal Growth Factor Receptor- Expressing Solid Tumors With AFM24, A Novel CD16A Bispecific Innate Cell Engager: Comprehensive Correlative Science Findings From A Phase 1 Study The first poster presentation includes correlative science findings from the phase 1 part of the ongoing monotherapy phase 1/2a study evaluating the safety and efficacy of AFM24 in patients with metastatic, treatment-refractory EGFR-positive solid tumors. In total, 35 patients with a range of tumor types were treated to date including patients with colorectal cancer, non-small cell lung cancer and other solid tumors were treated.NK cells in peripheral blood showed upregulation of activation markers which coincided with transient loss of NK cells from peripheral blood. This indicates migration of NK cells to the tumor. In addition, cytotoxic CD8-positive T-cell levels increased in the tumor, pointing to a crosstalk with the adaptive immune system. In all patients, AFM24 monotherapy demonstrated a well-managed safety profile. Poster Number 745: AFM24 and atezolizumab combination in patients with advanced epidermal growth factor receptor-expressing solid tumors: Initial results from the Phase 1 dose-escalation stud The second poster to be presented at SITC will include a data update from the phase 1/2a combination study evaluating AFM24 together with Roche's PD-L1 checkpoint inhibitor atezolizumab in patients with advanced, treatment-refractory EGFR+ solid tumors. The aim of the two-part study is to establish the recommended phase 2 dose of AFM24 in combination with atezolizumab as well as to assess initial data on the efficacy and safety of AFM24 in combination with atezolizumab. So far, four patients with gastric or pancreatic adenocarcinomas have been enrolled in the first dose cohort, with three completing the safety lead-in phase and receiving 160 mg AFM24 and atezolizumab. The preliminary data indicate that the combination of AFM24 and atezolizumab is a promising approach, with no dose-limiting toxicities observed. Among three patients evaluated in cohort 1, clinical activity was observed in two patients, while one patient awaited tumor assessment at cut-off date. One ongoing partial response was observed in a patient with gastric cancer and skin metastases who had rapidly progressed following four prior lines of therapy, including a PD-1 inhibitor, and an ongoing stable disease at 4+ months with symptomatic improvement was observed in a patient with pancreatic adenocarcinoma. Dose escalation is proceeding with an AFM24 dose of 480 mg.

08:41 EST NextCure presents initial data from trial of NC762, progress for NC410 combo - NextCure announced that clinical trial investigator Emese Zsiros, M.D., Ph.D. will present initial clinical data from a Phase 1 clinical trial of NC762 and Eric Christenson, M.D. will present a Trials in Progress poster for a combo study of NC410 at the Society for Immunotherapy of Cancer, SITC, annual meeting in Boston. The initial clinical data come from a Phase 1 study evaluating NC762, a monoclonal antibody that binds specifically to B7-H4, in patients with advanced/metastatic solid tumors. "We are pleased to share initial clinical data from our ongoing NC762 Phase 1 trial and provide additional details on our newly announced NC410 combination trial," said Han Myint, M.D., NextCure's chief medical officer. "We look forward to continuing NC762 in expansion cohorts where we will prospectively select B7-H4-positive tumors as assessed by a CLIA-validated assay we designed. In addition, we are excited to enroll the safety component of the NC410 combo trial and to report initial data in mid-2023."

08:40 EST Ingredion completes one-third of its $160M in capital investments - Ingredion Incorporated announced that it has completed one-third of its $160M in capital investments to significantly expand capacity for a range of modified and clean label specialty starches across its global supply chain. At the Company's June Investor Day, its leadership team announced $160M in capital investments through 2024 to selectively expand and increasingly localize its production capacity to meet customers' growing demands for specialty starches that provide texture for taste along with formulating and label-friendly options for food and beverages. In addition to providing capacity expansion for future growth, the moves are being made to reduce long-term delivered cost while taking into account the environmental footprint of the products being sold to customers.

08:39 EST Blue Apron: Partnerships remain a big focus

08:39 EST Iovance Biotherapeutics announces updated clinical data for Lifileucel - Iovance Biotherapeutics announced the publication of abstracts reporting clinical data and a trial in progress, TIP, for Iovance tumor-infiltrating lymphocyte, TIL, cell therapies for the upcoming Society for Immunotherapy of Cancer, SITC, Annual Meeting, November 8-12, 2022, in Boston, MA and virtually. The abstract reports on pooled consecutive cohorts from the C-144-01 trial with efficacy data from a total of 153 patients with advanced melanoma enrolled in Cohort 2 and Cohort 4. All patients had progressed on or after immune checkpoint inhibitor therapy, and targeted BRAF/MEK therapy where appropriate. Patients were heavily pre-treated and had substantial disease burden at baseline. The ORR assessed by an independent review committee using RECIST v1.1 was 31%, with 8 complete responses and 40 partial responses. mDOR was not reached, 42% of responses extended beyond 18 months, and 40% of responses were ongoing at the median study follow-up of 27.6 months. Median overall survival was 13.9 months. In patients who achieved a response at their first assessment, mOS had not been reached. The treatment-emergent adverse event profile was consistent with the underlying disease and known adverse event profiles of nonmyeloablative lymphodepletion and interleukin-2.

08:36 EST Blue Apron names Christopher Halkyard as chief supply chain officer - Blue Apron said that on November 3, the board of directors appointed Christopher Halkyard as the Company's Chief Supply Chain Officer, effective as of the commencement of Halkyard's employment with Blue Apron, LLC on November 7, 2022. Halkyard will serve as the company's principal operating officer. The company also announced that on November 1, the company and Charlean Gmunder mutually agreed that Gmunder would resign as the company's COO effective November 7, 2022. Comments taken from Q3 earnings conference call.

08:36 EST Huntington Ingalls unveils REMUS 620 unmanned underwater vehicle - HII's Mission Technologies division has revealed a new medium-class unmanned underwater vehicle: REMUS 620. Building on the design philosophy of the REMUS 300, the REMUS 620 has a battery life of up to 110 hours and a range of 275 nautical miles, providing mission capabilities for mine countermeasures, hydrographic surveys, intelligence collection, surveillance and electronic warfare. "Retaining a forward strategic advantage requires the ability to deliver a multitude of effects from under the sea," said Duane Fotheringham, president of Mission Technologies' Unmanned Systems business group. "The REMUS 620 is the first medium UUV designed to accurately deliver this range of advanced above-and-below water effects at long range."

08:34 EST Ballard Power now sees 2022 CapEx at lower end of $30M-$50M

08:34 EST Bolt Biotherapeutics to present preclinical data on BDC-3042 - Bolt Biotherapeutics announced that it will be presenting a poster with new preclinical data on BDC-3042, a Dectin-2 targeting agonistic antibody, at the 2022 Society for Immunotherapy of Cancer 37th Annual Meeting. The conference is being held both virtually and at the Boston Convention and Exhibition Center in Boston, Mass. from Nov. 8-12. Key Findings from the Study: Tumor-associated macrophages generally support tumor progression by suppressing anti-tumor immune responses. Dectin-2 is expressed by TAMs and agonism of Dectin-2 on TAMs has been shown to drive potent anti-tumor immunity in preclinical animal models. BDC-3042 is an agonistic, Dectin-2-targeted antibody designed to activate TAMs and mediate anti-tumor efficacy, offering a novel approach for macrophage-directed immunotherapy. BDC-3042 is designed to reprogram immunosuppressive TAMs into immunostimulatory cells that drive anti-tumor immunity; BDC-3042 selectively binds to Dectin-2-expressing macrophages and induces an array of pro-inflammatory cytokines, chemokines, and antigen presentation molecules; BDC-3042 exhibits minimal binding to and activation of peripheral leukocytes; BDC-3042 repolarizes TAMs toward an immunostimulatory phenotype and mediates anti-tumor activity in tumor-bearing humanized mice

08:31 EST Amarin highlights key data presented at AHA 2022 on VASCEPA/VAZKEPA - Amarin highlighted key data presented at the American Heart Association, AHA, 2022 Scientific Sessions relevant to VASCEPA/VAZKEPA and patient care. Important data at the meeting included RESPECT-EPA, A Randomized Trial for Evaluation in Secondary Prevention Efficacy of Combination Therapy - Statin and Eicosapentaenoic Acid and PROMINENT, Pemafibrate to Reduce Cardiovascular Outcomes by Reducing Triglycerides in Patients with Diabetes Study. The RESPECT-EPA clinical trial is an independent study funded by the Japanese Heart Foundation. Importantly, the study achieved a borderline statistical significance with a 21.5% reduction in the primary composite endpoint measuring cardiovascular risk and achieved a statistically significant 26.6% reduction in the secondary composite endpoint of RESPECT-EPA. In addition, a post-hoc analysis conducted by the investigators to control for attained EPA levels yielded a statistically significant 27.5% reduction in the primary endpoint. "We are very encouraged by the totality of these data presented at AHA 2022, as they further underscore the clinical and therapeutic value of VASCEPA/VAZKEPA for clinicians and tens of millions of patients globally," said Nabil Abadir, MB. CH.B., SVP, Chief Medical Officer and Head of Global Medical Affairs, Amarin. "Clinicians should make the best choice possible for their patients and should have confidence in VASCEPA as a proven treatment option on top of statins to reduce CV risk and to help optimize treatment in appropriate high-risk patients."

08:30 EST NV5 Global awarded $6M environmental services contract from Los Angeles County - NV5 Global announced that it has been awarded a $6M contract by the Los Angeles County Department of Public Works to provide environmental compliance services for infrastructure and facility projects across the county. The Department of Public Works is responsible for providing infrastructure and essential services to more than 10 million people across a 4,000 square mile service area. Under the five-year contract, NV5 will provide environmental site assessments, remediation management, and environmental compliance support. "Environmental regulations related to infrastructure and facilities exist at the federal, state, and local level, and achieving compliance to all of these standards can be a complex task," said Dickerson Wright, PE, Chairman and CEO of NV5. "NV5 has provided environmental expertise to Los Angeles County for more than 20 years, and we are pleased that our environmental expertise will continue to support the mission of the Los Angeles Department of Public Works to protect and enrich the daily lives of Los Angeles County residents."

08:28 EST Shattuck Labs presents updated preclinical data on GADLEN plarform - Shattuck Labs announced preclinical data from the company's novel GADLEN platform at the 2022 SITC Annual Meeting. Details of the presentation are as follows: Abstract title: Antigen targeted butyrophilin heterodimer-based bispecific engagers induce T cell-mediated anti-tumor activity Shattuck presented preclinical data highlighting the potential of GADLENs to direct Vgamma9delta2+ T cells to kill tumor cells. The bispecific GADLENs, which contain heterodimeric BTN2A1 and BTN3A1 extracellular domains fused via inert Fc linkers to scFv domains, targeting CD20 or B7-H3 antigens, demonstrated cytotoxic ability in coculture with Vgamma9delta2+ T cells. CD20-directed GADLENs enhanced the specific killing of lymphoma cells and healthy B cells that express the antigen, while B7H3-directed GADLEN increased the killing of B7-H3 expressing tumor cells. These studies shed light on the modularity of the GADLEN platform and the tumor cell markers which are important for the therapeutic activity of gamma delta T cell-based engager therapies.

08:26 EST Humacyte presents six-month HAV CABG data at American Heart Association - Humacyte announced updated six-month results of the Human Acellular Vessel, HAV, in a baboon Coronary Artery Bypass Graft, CABG, model. These data were presented in two oral presentations at the annual American Heart Association, AHA, Scientific Sessions meeting, held in Chicago, Illinois from November 5-7, 2022. Alan Kypson, M.D., FACS, thoracic surgeon at UNC Rex Hospital and lead investigator in Humacyte's large animal pre-clinical development of vessels for coronary artery bypass grafting, provided a six-month patency update of the HAV in a baboon CABG model in a presentation entitled "Six-Month Patency of Bioengineered Human Acellular Vessels in a Primate Model of Coronary Artery Bypass Grafting." The preclinical study assessed early patency at six months and the tolerability of a small-diameter HAV as the vascular conduit used in a primate CABG model. At six months, the HAV was explanted and studied with histological analysis. The HAVs were found to be repopulated with the subjects' own cells to resemble a native blood vessel and were patent, demonstrated by CT angiography. Humacyte's Chief Executive Officer, Laura Niklason, M.D., Ph.D., also presented a platform overview of the HAV in a presentation entitled, "From Concept to Patient: Bringing Inventions Forward." The HAV pipeline holds multiple potential commercial opportunities, including the vascular tissue construct indications of trauma and arteriovenous access in hemodialysis in Phase 3, peripheral arterial disease in Phase 2, and pediatric heart disease and CABG in pre-clinical stages. In addition, the development of advanced organ systems, including the biovascular pancreas, continue to progress through preclinical stages. Dr. Niklason provided an update on the first potential commercial indication for the HAV, vascular trauma, and reported that in the Phase 2/3 trial in vascular trauma the HAV performance-to-date compares favorably to both current standards of care, saphenous vein and expanded polytetrafluoroethylene grafts. In the Phase 2/3 trial to date the HAV has demonstrated low rates of amputation, low rates of infection, and zero instances of HAV rejection. Dr. Niklason additionally reviewed the ability for the HAV to potentially transform coronary artery bypass grafting with greater durability of surgical results and decreased morbidity of the procedure.

08:23 EST Barry Diller tells CNBC he hopes Netflix stays independent - Diller is Chairman and Senior Executive of IAC (IAC) and Expedia (EXPE).

08:22 EST BAE Systems to launch 1st ' low Earth orbit' multi-sensor satellite cluster - BAE Systems is set to launch its first multi-sensor satellite cluster into low Earth orbit in 2024 to deliver high-quality information and intelligence in real time from space to military customers. Known as Azalea , the group of satellites will use a range of sensors to collect visual, radar and radio frequency data, which will be analysed by on board machine learning on edge processors to deliver the resulting intelligence securely, anywhere in the world while still in orbit. Following the acquisition of In-Space Missions last year, BAE Systems is one of a small number of British companies with the capability to design, build, launch and operate satellites. The expertise brought by In-Space Missions complements the Company's existing advanced technologies and will become an integral part of its multi-domain capability. Azalea( will also boost the UK's ability to understand the threats and hazards in, from and through space.

08:21 EST Sabina Gold & Silver reports on project activities - Sabina Gold & Silver Corp. provides an update on advancements of the Goose Mine development at the Company's 100% owned Back River Gold District in Nunavut, Canada. The Goose Mine is the Company's first mine on the 80 km long Back River Gold District, a multi-generational mining district with a demonstrated high-grade world class gold endowment. Procurement & Sealift: A major component of the Company's de-risking strategy for the Project focused on early procurement which has mitigated against cost escalation pressures and supply chain backlogs. By July 2022, the Company had made commitments for approximately 75% of the total Project procurement: the focus being on priority construction items for delivery on this year's sealift. These items include equipment and supplies for site concrete work and the erection of plant and ancillary building shells and building envelopes. The 2022 sealift program included vessels from both the East and the West shipping hubs at Becancour and Hay River respectively. For the 2022 sealift, Sabina shipped and received approximately 12,500 million tonnes of dry goods via 2 cargo vessels and 8 ocean barges, mainly comprised of: the balance of the phase 1 permanent accommodation / kitchen dining / administration complex; Construction offices and equipment; Bulk construction materials; Select discipline construction materials; Building OH cranes, Emulsion plant, main generators; Ancillary buildings, additional fuel storage capacity, mining fleet spares; and Additional WIR equipment and mining equipment. In addition, Sabina successfully completed the delivery and offloading of 9.2 million liters of bulk diesel fuel into our storage tank at the Port Facility. As previously reported, Sabina has also procured its permanent 500 bed accommodation facility with the first phase of 280 beds delivered to the Port Facility already which is greater than camp personnel requirements for 2023. The remaining 220 beds required for operations were scheduled to be delivered this year but with the delayed start of the sealift from the west due in part to flooding in Hay River this Spring, the balance of the camp was not delivered. Should overflow be required in 2023, Sabina can utilize its existing 100 bed exploration camp at Goose. Approximately 2,301 MT of the 3,400 MT of cargo marshalled for delivery from the West, was deemed as critical to schedule. Sabina received approximately 2,283 MT of critical cargo at the Port Facility in 2022, also due to the delayed sealift start. The remaining 18 MT of priority cargo needed is comprised of structural steel and welding consumables for the additional 15M liter fuel farm tanks to be constructed at the Port Facility and Goose. These remaining items can be delivered to site via air. Committed purchase orders have been issued for all long-lead time packages and the Project is now ~90% procured, with a target of 95% of all packages to be committed to by the end of November 2022. Winter Ice Road: Sabina has executed a construction and maintenance contract with Nuna Logistics for the 2022/2023 Winter Ice Road. Nuna is the largest Inuit-owned heavy civil construction, earthworks and winter ice road contractor in Canada. Since 1993, Nuna has constructed the majority of Nunavut's and the Northwest Territories' exploration and mine site ice access roads. Their in-depth knowledge of northern operations enables them to mobilize, build, and maintain the reliable infrastructure required for continuous, cost-efficient operations in isolated regions of Northern Canada. Preparations for Sabina's WIR are underway with double headed construction of the road to begin in December 2022. Transportation operations are expected to start in February 2023 with an anticipated 1500 loads being moved from the MLA to Goose. Underground Development" Underground development continues to advance with approximately 1,200 meters complete and the first lateral access to the Umwelt Zone commencing. Preparations for development of the first ventilation raise have begun as well as underground exploration drilling of the Umwelt zone. 2023 Construction Preparation: Planned construction activities in 2023 will focus largely on building envelopes/frames and perimeter concrete. However, with procurement now substantially complete, Sabina intends to evaluate the detailed construction schedule and identify possible improvements to the timing for the delivery of specific work scopes.

08:19 EST Local Bounti partners with Sam's Club for leafy greens production - Local Bounti (LOCL) announced an offtake agreement with Walmart (WMT)-operated Sam's Club for its leafy greens production starting at its greenhouse facility in Byron, Georgia. Local Bounti will implement its Stack & Flow Technology at the new facility in Georgia, further enhancing capacity to meet existing demand. Stack & Flow Technology is Local Bounti's proprietary method of indoor farming, over 30 times more productive per acre than traditional agriculture.

08:18 EST Vicarious Surgical signs collaborative MOU with Pittsburgh CREATES - Vicarious Surgical announced it has signed a collaborative Memorandum of Understanding agreement with Pittsburgh CREATES, an innovation center that fosters collaborations between surgeons and healthcare professionals, with the academic and clinical resources of parent institutions, the University of Pittsburgh and UPMC Through this collaboration, Vicarious Surgical will further augment its development efforts with a world-renowned university. Expansion beyond the previously announced Center of Excellence partnerships provides Vicarious Surgical additional and diverse exposure to clinical and operational robotic experts, as well as access to the advanced Center for Pre-Clinical Studies within the University of Pittsburgh. Further expertise in surgeon testing, training and regulatory trials will help to provide deeper academic and clinical insight and support as the Company continues to advance through development and finalization efforts of its Vicarious Surgical robotic solution with a focus on helping to address the needs of major US hospital systems holistically.

08:17 EST Xwell enter partnership with Clockwork, bring robotic manicure to U.S. airports - XWELL, in partnership with Clockwork, will introduce fully autonomous, express manicures in select XpresSpa locations in the United States. Beginning in Q1 2023, XWELL will launch up to five of the latest version of Clockwork's AI-powered robot across the company's portfolio of 28 spa locations during an initial three-month period with the intent to deploy as many as 25 units across the business. "The partnership with Clockwork is a natural extension of our strategy to further leverage technology solutions to refresh our airport offerings," said XWELL Chief Executive Officer Scott Milford. "We are making self-care even more accessible by bringing high-quality, fast and affordable manicures to airport travelers. We are excited to offer this new beauty solution alongside our expanded line of retail products for women to help people on the go look and feel their best when they arrive at their destination."

08:14 EST Arsenal Capital Partners increases investment in Certara - Certara announced that Arsenal Capital Partners has committed to make a new $449M investment in Certara. Arsenal currently owns approximately 4% of common shares outstanding and will acquire approximately 30M additional shares from funds controlled by EQT Private Equity, at a price of $15 per share. Upon closing of the transaction, which is subject to HSR regulatory approval, Arsenal will own approximately 22% of diluted shares outstanding. Arsenal is deeply familiar with Certara's value proposition for all stakeholders. The firm previously held a majority stake in the company before selling a controlling interest to EQT in 2017. Arsenal continued to maintain a minority equity interest both before and after Certara's initial public offering in 2020. In a separate agreement with the company, Arsenal has agreed to a two-year lock-up prohibiting any sale of the newly purchased shares without company approval, reflecting Arsenal's commitment to being a long-term shareholder. Arsenal will also have the right, subject to maintaining certain ownership percentages, to nominate up to two board members, including current board member Stephen McLean. Following the closing of the transaction, Arsenal Operating Partner David Spaight is expected to join the board, and current board members Eric Liu and Ethan Waxman of EQT will step down from the board.

08:13 EST Climb Global appoints Boren to board of directors - The Board of Directors of Climb Global Solutions has appointed Kimberly Boren to the Board effective November 7, 2022. With the appointment of Boren, Climb's Board of Directors will return to seven members, six of whom are independent under the Nasdaq listing standards. Boren will serve on the Audit Committee and Compensation Committee of the Board of Directors. Boren brings over 25 years of experience leading and executing finance and accounting functions. Boren currently serves as the Chief Financial Officer of Learfield's Paciolan and Sidearm Divisions.

08:11 EST Alaunos Therapeutics to present data on its hunTR TCR Discovery platform - Alaunos Therapeutics announced a poster presentation highlighting the potential of the Company's human neoantigen T-cell receptor platform to expand its TCR Library. The data will be presented at the Society for Immunotherapy of Cancer's, SITC, 37th Annual Meeting in Boston, Massachusetts from November 8-12, 2022. Title: "hunTR: a hyperplex platform for the discovery of neoantigen-reactive T-cell receptors." In the study, Alaunos evaluated ~525,000 TCR+HLA+neoantigen combinations in nine patients across colorectal, endometrial and breast cancers. All patients screened had at least one detectable neoantigen-reactive TCR, including one shared KRAS-Q61H mutation and 21 personal mutations. Of these, 78% were restricted by HLA Class II while 22% were restricted by HLA Class I. A median reactive hit rate of 13% was achieved per patient with an average of three unique neoantigen specificities. In subsequent patients screened only for KRAS mutations, multiple patients had TCRs reactive to KRAS-G12V, further demonstrating the ability of hunTR to discover exclusively owned hotspot mutation-reactive TCRs that could be added to the clinical library. The Company plans to continue to expand the application of hunTR to screen for additional shared KRAS, TP53, and EGFR mutations to rapidly advance new TCR library candidates from the lab through to clinical translation. In addition, hunTR may be suitable for personalized TCR-T therapies, enabling mutation-targeted cell therapy for most solid tumor cancers.

08:11 EST Heliogen signs MOU with The City of Lancaster - The City of Lancaster announced the signing of a memorandum of understanding, or MOU, with Heliogen, a California-based renewable energy technology company that uses concentrating solar thermal systems to convert sunlight into steam, heat, power, and green hydrogen fuel. Under the terms of the MOU, Heliogen will serve as the technology provider, project developer, builder, operator, and equity partner for a green hydrogen generation facility that will support the city's vision to become a model for hydrogen production in the U.S. This relationship is expected to accelerate the novel use of concentrating solar thermal energy for a commercial hydrogen generation facility and builds upon the existing relationship between the City of Lancaster and Heliogen, which sited its demonstration test facility in the city in 2019.

08:10 EST Beyond Meat expands chicken portfolio with Chicken Nuggets, Popcorn Chicken - Beyond Meat (BYND) launched Beyond Chicken Nuggets and Beyond Popcorn Chicken, the latest additions to Beyond Meat's chicken platform that also includes Beyond Chicken Tenders. The new plant-based chicken products will launch at more than 5,000 Kroger (KR) and Walmart (WMT) stores nationwide, as well as at select Albertsons (ACI) and Ahold divisions and other retailers across the country.

08:09 EST Viatris to acquire Oyster Point Pharma and Famy Life Sciences - Viatris announced that it intends to create an ophthalmology franchise by acquiring Oyster Point Pharma and Famy Life Sciences and that it will provide a strategic update on its February 2022 Investor Event in a conference call and live webcast today at 8:30 a.m. ET. Under the terms of a definitive agreement, Viatris has agreed to acquire Oyster Point for $11 per share in cash upfront through a tender offer. In addition, each Oyster Point stockholder will receive one non-tradeable contingent value right, representing up to an additional $2 per share contingent upon Oyster Point's achieving certain metrics based on full year 2022 performance. Viatris is targeting to close the acquisition of Oyster Point in Q1 2023, subject to customary closing conditions, including receipt of regulatory approval, and tender acceptance of more than 50% of Oyster Point shares.Concurrently, the company also expects to acquire Famy Life Sciences, which has a complementary ophthalmology portfolio. The company anticipates these acquisitions have the potential to add at least $1B in sales by 2028. As a result of the expected strong top-line growth, the company anticipates it will also add at least $500M in adjusted EBITDA by 2028. Together, the two acquisitions have an aggregate purchase price of approximately $700-$750 million which Viatris expects to fund with cash on hand.

08:07 EST Oryzon Genomics announces data presentation on Phase II ALICE trial - Oryzon Genomics announced that its communication reporting final data from its ongoing and fully accrued Phase IIa ALICE trial, investigating iadademstat in combination with azacitidine in elderly or unfit patients with acute myeloid leukemia has been selected for oral presentation at the upcoming 64th American Society of Hematology Annual Meeting and Exposition, to be held December 10-13, 2022 in New Orleans. The communication entitled "Iadademstat Combination with Azacitidine Is a Safe and Effective Treatment in First Line Acute Myeloid Leukemia. Final Results of the ALICE Trial" will be presented as an oral presentation by Dr. Olga Salamero, MD from the Vall d'Hebron Hospital in Spain, during Session 616: "Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Frontline and Maintenance", on Monday December 12th at 11.15 am ET at the Ernest N. Morial Convention Center, room 275-277. Dr. Carlos Buesa, Oryzon's CEO, said: "These results confirm previous data in supporting a strong synergy between iadademstat and azacitidine in combination. It is highly encouraging that we continue to see high levels of response and extended remissions, alongside good tolerability. We feel honored by this selection for an oral presentation and this reflects the interest for the therapeutical potential of the LSD1 inhibition in the field"

08:06 EST Surface Oncology to present non clinical data for SRF388, SRF114 - Surface Oncology announced the presentation of two posters at the 2022 Society for Immunotherapy of Cancer, SITC, Annual Meeting in Boston. The posters feature new non-clinical data for both SRF388 and for SRF114 and will be presented on Friday, November 11, 2022. "We are very pleased to share intriguing new non-clinical data that suggest there is immune-suppressive cross-talk between IL-27 and PD-L1 expression within the tumor microenvironment," said Vito Palombella, PhD, Chief Scientific Officer, Surface Oncology. "Immunohistochemical analysis of IL-27, the IL-27 receptor, and PD-L1 shows co-localization across several cancer types, and in vitro studies have shown that IL-27 can directly upregulate PD-L1 expression on both immune and tumor cells. These data support our ongoing clinical studies evaluating SRF388, our first-in-class, fully human anti-IL-27 antibody, in combination with pembrolizumab." SITC Poster Presentations: Title: IL-27 expressed in the tumor microenvironment is correlated with PD-L1 levels and can induce PD-L1 expression on immune and tumor cells. Summary of key data: Primary tumor samples from several cancers including lung, liver, renal, gastric, and head and neck, have IL-27+ tumor associated macrophages; IL-27-expressing TAMs are localized within the vicinity of PD-L1+ tumor cells in lung and liver cancers, with the highest IL-27+ density being associated with the highest PD-L1 expression; IL-27 can regulate PD-L1 expression in immune cells and tumor cell lines. Title: SRF114, an afucosylated anti-CCR8 antibody, depletes intratumoral Treg cells and reduces tumor growth. Summary of key data: CCR8 expression is highest on intratumoral regulatory T cells compared to peripheral Tregs and other immune cells; SRF114 treatment results in dose-dependent activation of immune cells, including natural killer cells and monocytes; In dissociated tumor cultures, SRF114 selectively depletes Treg cells and has limited impact on effector T cells; in a mouse model, SRF114 treatment significantly reduces tumor growth and depletes intratumoral Treg cells, with minimal impact on peripheral Tregs.

08:05 EST Viatris to acquire Oyster Point for $11 per share plus CVR up to $2.00 per share - Oyster Point Pharma (OYST) announced that it has entered into a definitive agreement under which Viatris Inc. (VTRS) would acquire Oyster Point Pharma. Viatris intends to acquire Oyster Point Pharma as the foundation of its new ophthalmology franchise, recognizing its uniquely talented team, the strength of TYRVAYA Nasal Spray and Oyster Point Pharma's pipeline. Under the terms of the agreement, Viatris will commence a tender offer to purchase all outstanding shares of Oyster Point Pharma for $11.00 per share in cash at closing, plus a contingent value right for a potential cash payment of up to $2.00 per share upon achievement of specified performance targets by Oyster Point Pharma for full year 2022. The transaction was unanimously approved by the Oyster Point Pharma Board of Directors. In November 2021, Oyster Point Pharma launched TYRVAYA, the first and only FDA-approved nasal spray for the treatment of the signs and symptoms of dry eye disease. In addition, Oyster Point Pharma has a growing pipeline of clinical and pre-clinical programs aimed at delivering transformative innovation for ocular surface diseases. In addition to TYRVAYA, Oyster Point Pharma has three drug candidates in its pipeline: two investigational therapies for neurotrophic keratopathy, a severe degenerative condition affecting the nerves of the cornea, and another for vernal/atopic keratoconjunctivitis, a severe allergic condition of the eyes. Under the terms of the agreement, Viatris will initiate a tender offer to acquire all of the outstanding shares of Oyster Point Pharma's common stock at a price of $11.00 per share in cash at closing, plus a contingent value right representing the right to receive a potential cash payment of up to $2.00 per share. The amount payable under the CVR will be based on the following performance targets to be achieved by Oyster Point Pharma for full year 2022: An additional $1.00 per share in cash if Oyster Point Pharma generates equal to or greater than $21.6 million of net product revenues and 131,822 total prescriptions of TYRVAYA; or An additional $2.00 per share in cash if Oyster Point Pharma generates equal to or greater than $24.0 million of net revenue and 146,469 total prescriptions of TYRVAYA. The transaction is subject to customary closing conditions, including the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, and the tender of a majority of the outstanding shares of Oyster Point Pharma's common stock. Oyster Point Pharma stockholders holding approximately 46% of Oyster Point Pharma's common stock have entered into a tender and support agreement with Viatris, pursuant to which such stockholders have agreed, among other things, to tender 100% of their shares of Oyster Point Pharma's common stock in the tender offer, subject to the terms and conditions of such agreement. Following the successful closing of the tender offer, Viatris will acquire all remaining shares of Oyster Point Pharma's common stock that are not tendered into the tender offer through a second-step merger at the same price of $11.00 per share, plus a CVR representing the right to receive up to $2.00 per share. The transaction is anticipated to close during the first quarter of 2023.

08:04 EST Oncolytics reports interim results from Phase 1/2 GOBLET study - Oncolytics Biotech (ONCY) reported interim results from the phase 1/2 GOBLET study's first-line advanced/metastatic pancreatic ductal adenocarcinoma cohort in an abstract published as part of the Society for Immunotherapy of Cancer 37th Annual Meeting. As of the abstract's data cutoff date, July 28, 2022, seven of ten evaluable patients in GOBLET's PDAC cohort, which evaluates pelareorep in combination with Roche's (RHHBY) anti-PD-L1 checkpoint inhibitor atezolizumab and the chemotherapeutic agents gemcitabine and nab-paclitaxel, achieved a partial response (3 confirmed, 4 unconfirmed as of the cutoff date). An additional two patients achieved stable disease for an ORR and clinical benefit rate of 70% and 90%, respectively. No safety signals were observed with the studied combination.

07:45 EST Jumia Technologies Co-CEOs Jeremy Hodara, Sacha Poignonnec step down - Jumia Technologies announced the appointment of a new Management Board and Acting CEO, while Jeremy Hodara and Sacha Poignonnec, Co-CEOs, will be stepping down effective today. The Supervisory Board has appointed Francis Dufay and Antoine Maillet-Mezeray as members of the Company's Management Board. Dufay is appointed Acting CEO. He has been with the Company since 2014 and has held multiple senior leadership roles, including CEO of Ivory Coast and recently EVP Africa with responsibility for the group's e-commerce business across Africa. Antoine Maillet-Mezeray previously Group CFO, has been elevated to Executive Vice President, Finance & Operations. Antoine has been with Jumia for over six years and has played an instrumental role in driving the finance function and further developing it in a public market context. Francis, Antoine and the broader leadership team will work together closely to drive the Company's strategic priorities and operations with a clear focus on: Building even stronger fundamentals for our e-commerce businesses by refocusing teams and resources on activities and projects delivering the best added value to consumers, sellers and the broader Jumia ecosystem. Reducing operating losses and setting the business on a clear path to profitability, through stronger cost discipline, targeted monetization initiatives and a more simplified and efficient organization. The Company will be making select senior management changes with a focus on locating leaders and decision centers closer to consumers and sellers in Africa. In parallel, a search for a permanent CEO is ongoing.

07:43 EST ARway trading in the U.S. under ARWYF - ARway is pleased to announce that its common shares are now available for trading in the USA on the OTC Pink Sheet Open Market under the stock symbol: ARWYF On October 26th, 2022 ARway was spun-out by Nextech AR Solutions (NEXCF), and directly listed on the CSE at a price of $0.25. The last quote on November 4th 2022 was $1.49 on the CSE representing a 600% increase in value. Nextech AR is focused on creating shareholder value by acquiring or developing transformative 3D, AR and AI technologies incubating them and then bringing them to market directly or through a spin-out transaction.

07:40 EST Cytokinetics presents new data at American Heart Association sessions - Cytokinetics announced new data from two additional analyses from GALACTIC-HF, as well as an analysis of patients hospitalized for heart failure with reduced ejection fraction from the Get With The Guidelines-Heart Failure Registry, were presented at the American Heart Association Scientific Sessions 2022 in Chicago, IL. Reduction in Heart Failure Events for North American Patients Treated with Omecamtiv Mecarbil in GALACTIC-HF Associated with 26.9% Cost Reduction over Three Years: Nihar Desai presented data from an analysis of the healthcare resource use, early benefit and costs of hospitalization for North American patients with heart failure with reduced ejection fraction treated with omecamtiv mecarbil in GALACTIC-HF. This analysis included 1,090 North American patients from GALACTIC-HF matching the criteria of a subgroup of patients previously identified as being the most likely to benefit from treatment with omecamtiv mecarbil. In this subgroup, treatment with omecamtiv mecarbil was associated with a reduction in the risk of the primary composite endpoint of cardiovascular death or first heart failure event and a reduction in the risk of first heart failure event. The estimated cost reduction due to heart failure events avoided with omecamtiv mecarbil averaged $420 per patient at 30 days, $928 per patient at 90 days, and $6,052 per patient at 3 years, suggesting that treatment with omecamtiv mecarbil is associated with both a clinical and economic benefit for patients with HFrEF. Women Enrolled in GALACTIC-HF Had Lower Quality of Life at Baseline and Lower Rate of the Primary Outcome; Treatment Benefit from Omecamtiv Mecarbil Did Not Differ from Men: Maria Pabon Porras presented data from an analysis from GALACTIC-HF on sex differences in baseline characteristics, clinical outcomes, efficacy and safety of omecamtiv mecarbil. Of 8,232 patients enrolled, 1,749 were women. At baseline, women had lower Kansas City Cardiomyopathy Questionnaire scores, indicating they had worse quality of life, and they were less likely to be treated with guideline recommended medical therapies and devices than men. For both men and women, KCCQ scores at baseline were highly predictive of incidence rates of the primary outcome, however, compared to men, women had a 20% lower adjusted risk of the primary composite endpoint, and had lower rates of serious adverse events than men. The treatment effect of omecamtiv mecarbil did not differ between men and women.

07:40 EST Jumia appoints Francis Dufay acting CEO as Co-CEOs Hodara, Poignonnec leave - "Jumia Technologies announced the appointment of a new Management Board and Acting CEO, while Jeremy Hodara and Sacha Poignonnec, Co-CEOs, will be stepping down effective today," said the company. The Supervisory Board has appointed Francis Dufay and Antoine Maillet-Mezeray as members of the Company's Management Board.Francis Dufay is appointed Acting CEO. He has been with the Company since 2014 and has held multiple senior leadership roles, including CEO of Ivory Coast and recently EVP Africa with responsibility for the group's e-commerce business across Africa. Francis has a track record of successfully scaling e-commerce operations in Africa with a strong focus on profitability. Based in Ivory Coast since 2014 and an Ivorian national, Francis brings a deep understanding of our business and the markets that we operate in.Antoine Maillet-Mezeray previously Group Chief Financial Officer, has been elevated to Executive Vice President, Finance & Operations. Antoine has been with Jumia for over six years and has played an instrumental role in driving the finance function and further developing it in a public market context. Jonathan Klein, Chairman of the Supervisory Board, said of the announcement, "We thank Jeremy and Sacha for their leadership over the last decade to envision and build a company that became the leading pan-African e-commerce player. As we look ahead to the next chapter of Jumia's journey, we want to bring more focus to the core e-commerce business as part of a more simplified and efficient organization with stronger fundamentals and a clearer path to profitability. We look forward to working closely with Francis, Antoine and the leadership team to execute on these objectives and continue on our mission of offering a compelling e-commerce platform to consumers, sellers and the broader Jumia ecosystem in Africa."

07:39 EST AirBoss of America receives $40.6M in orders for Husky 2G vehicles - AirBoss of America Corp. announced that its wholly-owned subsidiary, AirBoss Defense Group, has received a $35M order for ten Husky 2G counter-improvised explosive device vehicles. The vehicles will be equipped with a full complement of detection systems and periphery subsystems including ground penetrating radar, M20 Interrogation Arms, Rollover Detection Systems, thermal cameras and RPG-defeat netting. ADG is also responsible for providing comprehensive operator and maintainer training as well as spare parts and sustainment supplies to the customer. Delivery of the vehicles is expected to take place over the next 16 months. Furthermore, ADG, through its partner, DCD Protected, will be providing three Husky 2G C-IED vehicles, peripheral detection and survivability systems to support a customer in West Africa, valued at up to $5.6M. ADG and DCD will also be providing spare parts and sustainment supplies as well as comprehensive operator and maintainer training. This contract, with deliveries expected to take place over the next six months, will provide a route clearance and threat detection and interrogation capability that will aid in the ongoing war on terror and efforts to counter a growing extremist threat in the region.

07:37 EST Cronos Group on track to achieve $20-$25M in operating expense savings in 2022 - Following the decision to begin a phased exit of the wholesale beauty category in the U.S. business in the second quarter of 2022, the Company continued to reduce operating expenses in the U.S. to better align the business structure with the new strategy to focus on adult-use product formats in the direct-to-consumer channel. The Company remains on track to achieve the previously identified $20 to $25 million in operating expense savings for 2022, primarily driven by savings in sales and marketing, general and administrative, and research and development.

07:33 EST Verve Therapeutics falls 21% after Q3 results, FDA hold on VERVE-101 trial - In pre-market trading, shares are down 21% to $24.79.

07:33 EST Rallybio announces topline results from RLYB116 SAD study - Rallybio announced topline results from its Phase 1 single ascending dose, or SAD, study in healthy participants of RLYB116, an innovative potentially long-acting, subcutaneously injected inhibitor of complement component 5, in development for the treatment of patients with complement-mediated diseases. In the ongoing Phase 1 study, all study participants that were administered a single one mL subcutaneous injection of 100 mg of RLYB116 demonstrated a reduction in free C5 greater than 99% within 24 hours of dosing. The terminal elimination half-life of RLYB116 was greater than 300 hours. Subcutaneously administered RLYB116 was observed to be generally well-tolerated at the 100 mg dose, with mild or moderate adverse events and no drug-related serious adverse events reported.

07:26 EST Charge Enterprises signs master service agreement for EV charging station - Charge Enterprises announced that its portfolio company Charge Infrastructure and Unity Construction Services signed a master service agreement for the strategy and development of EV charging stations and related services. Unity has named Charge as a preferred provider for developments built by Unity Construction. Charge will provide Unity seamless EV charging infrastructure solutions and services to support the unique needs of its clients. Unity builds facilities for some of the nation's top real estate developers, online retailers, science and technology firms, financial, healthcare, and industrial companies.

07:21 EST Charge Enterprises, Unity Construction Services sign master services agreement - Charge Enterprises announced that its portfolio company Charge Infrastructure and Unity Construction Services signed a master service agreement for the strategy and development of EV charging stations and related services. Unity has named Charge as a preferred provider for developments built by Unity Construction. Charge will provide Unity seamless EV charging infrastructure solutions and services to support the unique needs of its clients.

07:20 EST Marimaca Copper secures water option for life of mine seawater supply - Marimaca Copper entered into a water option agreement to secure the future water supply required for the Marimaca Copper Project in Chile. Under the agreement, seawater would be supplied following its use in cooling systems at an electricity plant in Mejillones, located 25km from the Project and operated by one of Chile's largest energy suppliers. The option has a term of 5 years, with the ability to extend for 2 years, and will allow the Company to advance final Project permitting and technical studies, including water pipeline studies that are already underway. The exercise of the option will trigger the execution of a water supply agreement priced on a take-or-pay basis for the Project's life of mine, the principal terms of which have been negotiated and agreed in the option documentation. The agreed pricing arrangement is at a lower cost than originally projected in the 2020 Preliminary Economic Assessment. As disclosed in the PEA, and consistent with Marimaca's 5 phases of metallurgical test work, the Project is designed to use seawater-based process solutions in place of fresh water.

07:18 EST Talaris Therapeutics presents data on mechanisms of FCR001 - Talaris Therapeutics presented new data characterizing the mechanisms of FCR001-induced immune tolerance in two oral presentations at the 2022 American Society of Nephrology, ASN, Annual Meeting. The first presentation reported on transcriptional changes following successful tolerization with FCR001. Urinary cell mRNA profiling was conducted on 19 patients tolerized with FCR001 in the Company's Phase 2 clinical trial and 159 control patients who received a living donor kidney transplant but were not treated with FCR001. The analysis identified a unique urinary cell mRNA signature that is consistent with immune quiescence as defined by the ratio of CTLA-4 to granzyme B mRNA, which is significantly higher in the FCR001 cohorts compared to the control cohorts. In a second oral presentation, the Company reported data on the specific composition of patients' peripheral blood mononuclear cells following treatment with FCR001 in a small cohort of patients enrolled in the Company's Phase 3 FREEDOM-1 trial. Longitudinal single-cell RNA sequencing was conducted on PBMCs from three patients treated with FCR001 and one patient in the standard of care control arm treated with immunosuppressants. The analysis found that immune reconstitution following FCR001 treatment was characterized by important changes in natural killer cell and B cell sub-populations, and that this immune activation preceded observation of clinical manifestations.

07:16 EST Cellebrite announce opening of Angleton Police Department digital forensics lab - Cellebrite DI announced the opening of the Angleton Police Department's digital forensics lab. Corporal Detective, CD, Cory Budnick was able to show the City Council how investment in the technology for his department could decrease time to evidence by weeks. The Angleton City Council approved his department's simultaneous investment in Cellebrite's UFED and Cellebrite Premium as a Service.

07:14 EST Osisko Gold to acquire royalty on SolGold's Cascabel Project - Osisko Gold Royalties (OR) announce that it has entered into a binding agreement with SolGold plc (SLGGF) with respect to a $50M royalty financing to support the advancement of SolGold's Cascabel copper-gold property in northeastern Ecuador. As part of the Transaction, Osisko will acquire a 0.6% net smelter return royalty covering the entire 4,979 hectare Cascabel property, including SolGold's world-class Alpala project for which SolGold released the results of a pre-feasibility study in April of 2022. INVESTMENT HIGHLIGHTS: Exceptional Royalty on one of the Most Significant Cu-Au Discoveries: NSR covers the Cascabel property comprising 4,979 hectares of Andean Copper Belt; Total resources at Cascabel currently represent approximately 20% and 16% of the total copper and gold in new major deposit discoveries since 2012; Based on the PFS, the NSR would average approximately 4,700 annual gold-equivalent ounces to Osisko over an initial 26-year mine life and 7,600 GEOs over the first 10-years of nameplate production. Exposure to the Large-Scale Alpala Project: The Alpala deposit is SolGold's principal focus on the broader Cascabel property. The PFS study on Alpala outlined a large underground block cave mine with an initial 26-year mine life based on Probable Reserves; Alpala Probable Reserves contain 3.3 Mt of Cu, 9.4 Moz of Au and 30 Moz of Ag; Alpala is estimated to produce an average of 132 kt Cu and 358 koz Au annually over the life of mine with peak annual production of 210 kt Cu and 829 koz Au; Based on the PFS, Alpala is expected to rank in the first decile in terms of production costs. Further Exploration Potential Within the Broader Property: Presence of regional targets on the Cascabel property that have similar geophysical and geochemical characteristics to known mineralized porphyry clusters on the property; The PFS mine plan did not include a further 2 billion tonnes of resources which may supplement production; A number of prospective targets across the Cascabel concession in addition to the discovered Alpala and Tandayama-America deposits. TRANSACTION DETAILS: Osisko will make an upfront cash payment to SolGold of $50 million in exchange for the NSR; The NSR will be a life-of-mine instrument covering the entirety of the Cascabel property including the Alpala project; Beginning in 2030 and until the end of 2039, Osisko will receive minimum annual payments under the NSR of $4 million; SolGold shall have a right to buydown one-third of the NSR percentage for 4 years; Osisko has made a three-year commitment to fund certain ESG initiatives at the project; Closing of the Transaction is subject to customary conditions precedent.

07:13 EST Bowman announces 'immediately accretive' purchase of SEI Engineering, no terms - Bowman Consulting Group announced the purchase of SEI Engineering . Headquartered in Paonia, Colorado and operating as SEI Professional Services, the company provides a full array of technical services to developers and owners of utility and commercial scale solar energy facilities. The SEIE team is made up of many of the solar industry's top photovoltaic and battery storage system designers, engineers, and technicians. "Our renewable energy business is growing at a rapid rate and the acquisition of SEIE will serve to further accelerate that growth," said Gary Bowman, CEO of Bowman. "Planning, engineering, and commissioning related to energy transition is a primary focus of our growth strategy and is central to our acquisition program. The leadership team at SEIE is extraordinarily knowledgeable and highly respected as experts throughout the solar industry. They were especially attracted to our growth culture and are looking forward to the advancement opportunities that a larger organization can provide. They will integrate quickly into our operation, and we are highly confident that this move will result in significant cross-selling and revenue synergies. I'm looking forward to the opportunities this acquisition will present to advance our penetration into the growing market for alternative energy engineering services." The Company expects the SEI acquisition to initially contribute approximately $1.5M of annualized net service billing and be immediately accretive. The acquisition was financed with a combination of cash and seller notes.

07:12 EST Avalo sells economic rights to previously out-licensed assets for $5M - Avalo Therapeutics (AVTX) announced it entered into a purchase agreement to sell its economic rights to future payments for previously out-licensed assets including AVTX-007, AVTX-501, and AVTX-611 to ES Therapeutics in exchange for $5.0 million. The sale is expected to close in November. "This transaction will strengthen our balance sheet and further demonstrates the execution of our strategy to utilize business development to fund our core programs," said Garry Neil, MD, Chief Executive Officer and Chairman of the Board of Avalo Therapeutics. "Once completed, we will have raised $20 million of nondilutive funding since August. These transactions meaningfully improve our financial position and support our lead asset, AVTX-002, which remains on track to deliver data from our Phase 2 PEAK trial in non-eosinophilic asthma in the first half of next year." Pursuant to the purchase agreement, at the closing of the transaction Avalo will sell to ES all of Avalo's rights to any milestone payments under the Asset Purchase Agreement, dated August 14, 2017, by and between Avalo and Janssen Pharmaceuticals (JNJ), and any future milestone and royalty payments under the License Agreement, dated July 29, 2022, by and between Apollo AP43 Limited and Avalo, and will waive all rights, including all payments due to Avalo from ES, under the Assignment of License Agreement, dated August 8, 2019, by and among Avalo, ES and Armistice Capital Master Fund. The purchase agreement contains customary representations and warranties and covenants of the Company and ES. ES is an affiliate of Armistice, which is a significant stockholder of the Company.

07:10 EST ESAB initiates retail partnership with Northern Tool + Equipment - ESAB announced its retail partnership with Northern Tool + Equipment,. The partnership features flagship products from key brands for welders and fabricators of all abilities through the ESAB brand portfolio. "ESAB is thrilled to partner with a trusted retailer like Northern Tool + Equipment in the U.S. This partnership means welders and fabricators of all experience levels - from the casual welder to the professional - have expanded access to our best-in-class products by increasing availability into more mainstream retail channels," said Shyam P. Kambeyanda, President and Chief Executive Officer of ESAB Corporation. "With a laser focus on delivering on our growth strategy and expanding our presence in the North American market, we look forward to building on our relationship with Northern Tool + Equipment and identifying additional opportunities in retail to give welders and fabricators across the country the opportunity to experience

07:09 EST Ionis Pharmaceuticals presents positive Phase 2 results in nephropathy - Ionis Pharmaceuticals presented positive results from a Phase 2 clinical study of IONIS-FB-LRx in patients with immunoglobulin A nephropathy. Results were presented at the American Society of Nephrology's Kidney Week 2022. In the Phase 2 study, IONIS-FB-LRx met its primary endpoint of change in 24-hour urinary protein, demonstrating a 44% mean reduction in proteinuria from baseline to week 29. Kidney function, as measured by estimated glomerular filtration rate, was maintained in all patients in the study. IONIS-FB-LRx achieved robust and sustained reductions in plasma complement Factor B, Alternative Pathway Activity, and urinary complement fragment Ba. IONIS-FB-LRx also demonstrated a favorable safety and tolerability profile in this study.

07:07 EST TriNet commences modified 'Dutch auction' to repurchase $250M of common stock - TriNet Group announced that it has commenced a modified "Dutch auction" tender offer to purchase for cash up to $250M in value of its common stock at a price per share not less than $63.00 and not greater than $72.00, less any applicable withholding taxes and without interest, using available cash on hand. On November 4, 2022, the closing price of the Common Stock was $61.75 per share. The Tender Offer will expire at 12 midnight, New York City time, at the end of the day on December 6, 2022, unless extended or terminated.

07:06 EST Amicus announces upcoming milestones by program - Galafold Oral Precision Medicine for Fabry Disease: Sustain double-digit revenue growth in 2022 of 15-20% at CER; Continue geographic expansion; Registry and other Phase 4 studies ongoing. AT-GAA for Pompe Disease: FDA deferred action on the AT-GAA filing until a manufacturing site inspection can be conducted. Per the Agency's guidance, a Type A meeting has been requested to develop plans and logistics for the pre-approval inspection EU Committee for Medicinal Products for Human Use opinion expected in December 2022; Continue to broaden expanded access programs in the U.S., U.K., Germany, France, Japan, and other countries; Ongoing supportive studies, including pediatric and extension studies

06:56 EST Castellum signs LOI to acquire $10M government contractor - Castellum signed a Letter of Intent to acquire an East-coast-based government contractor generating approximately $10M in revenue. Subject to due diligence and the execution of a definitive purchase agreement, the company hopes to close the acquisition by the end of January 2023.

06:53 EST Eagle Pharmaceuticals sees FY22 adjusted non-GAAP R&D expense less than $40M - As compared to $32.5M in 2021. Adjusted non-GAAP SG&A expense for the full year 2022 is expected to be in the range of $64M-$68M, as compared to $54.9M in 2021.

06:50 EST NiSource to sell a minority interest in NIPSCO business following review - NiSource announced actions it plans to take based on its previously announced business review. The company will share details at an Investor Day event at the New York Stock Exchange. Acting on the review, the company intends to sell a minority interest in its NIPSCO business. The proposed minority sale, when completed, is expected to minimize future external capital market needs and is expected to eliminate all equity needs until at least 2025, at which time a modest ATM program is expected to be put in place to maintain credit metrics as growth investments continue. The review also identified opportunities to optimize NiSource's cost profile and approach to work. The scope of the business review included: benchmarking of other utilities, assessments of legislative and regulatory support for long term investments in each of NiSource's states, analysis of options to optimally finance the growth plan, and strategic merger and acquisition opportunities.

06:47 EST Merck reports updated systematic literature review of GARDASIL - Merck announced that an updated systematic literature review examining the global impact and effectiveness of HPV vaccination using GARDASIL was published online in the journal Expert Review of Vaccines. This systematic review observed that use of GARDASIL led to reductions in the rates of high-grade and low-grade cervical lesions, as well as reductions in certain non-cervical HPV-related diseases and HPV infection in women and men. The systematic review included 138 peer-reviewed studies, published between March 1, 2016, and March 31, 2020. It details the impact and effectiveness of GARDASIL through immunization programs in 23 countries, across Africa, Asia, Europe, Australia, South America and North America and builds on a prior review of real-world data published in 2016. The previous real-world analysis was based on 58 peer-reviewed studies published between Jan. 1, 2007, and Feb. 29, 2016, across Australia/New Zealand, Europe and North America. Studies examining GARDASIL 9 were not included in this review.

06:44 EST NRG Energy sees 2023 Adjusted EBITDA $2.27B-$2.47B

06:40 EST Triumph Bancorp commences "Dutch auction" tender offer for $100M in stock - Triumph Bancorphas commenced a modified "Dutch auction" tender offer to purchase for cash up to $100M of its common stock at a price per share not less than $51.00 and not greater than $58.00, less any applicable withholding taxes and without interest, using available cash on hand. On November 4, 2022, the closing price of the Common Stock was $49.35 per share. The Tender Offer will expire at 12:00 midnight, New York City time, at the end of the day on December 6, unless extended or terminated. If the Tender Offer is fully subscribed, the Company will purchase between 1,960,784 shares and 1,724,137 shares, or between 8.01% and 7.04%, respectively, of the company's outstanding Common Stock. The company reserves the right to accept for purchase pursuant to the Tender Offer up to an additional 2% of its outstanding Common Stock without extending the expiration date of the Tender Offer. All shares accepted in the Tender Offer will be purchased at the same price even if tendered at a lower price. The Tender Offer will not be contingent upon any minimum number of shares being tendered or any financing conditions.

06:36 EST Ritchie Bros. to acquire IAA in stock, cash transaction valued at $7.3B - Ritchie Bros. Auctioneers (RBA) and IAA (IAA) announced that they have entered into a definitive agreement under which Ritchie Bros. will acquire IAA in a stock and cash transaction valued at approximately $7.3B including the assumption of $1B of net debt. The transaction has the unanimous support of both boards of directors. Under the terms of the merger agreement, IAA stockholders will receive $10.00 in cash and 0.5804 shares of Ritchie Bros. common stock for each share of IAA common stock they own. The purchase price of $46.88 per share represents a premium of approximately 19% to the closing share price of IAA common stock on November 4, 2022, and 23% to the 10-day volume-weighted average price, using Ritchie Bros.' 10-day volume-weighted average price on the NYSE of $63.55. The total purchase price also reflects a transaction multiple of 13.6x IAA's last twelve-month Adjusted EBITDA3 as of October 2, 2022. Upon completion of the transaction, Ritchie Bros. stockholders will own approximately 59% of the combined company and IAA stockholders will own approximately 41%. Ann Fandozzi will continue to serve as CEO of the combined company. The Ritchie Bros. Board of Directors will expand to add IAA CEO and President John Kett and three other current members of the IAA Board following the close of the transaction. Erik Olsson, chairman of the Ritchie Bros. Board, will serve as chairman of the Board of the combined company. Ritchie Bros. will continue to be legally incorporated in Canada and will retain its offices and employee base in Burnaby, British Columbia and IAA's Chicago, Illinois offices will serve as the official headquarters of the combined company. As of the transaction closing, approximately two thirds of the workforce will be in the United States on a combined basis. Following the transaction close, Ritchie Bros. will continue to trade under the symbol RBA on both the NYSE and TSX. The transaction is expected to close in the first half of 2023 subject to approval by Ritchie Bros. stockholders of the issuance of Ritchie Bros. stock in connection with the transaction and approval of IAA stockholders of the transaction, receipt of regulatory approvals and other customary closing conditions. Ritchie Bros. intends to fund the cash consideration of the transaction through a combination of cash on hand and new debt. The Company has bridge financing commitments in place from Goldman Sachs, Bank of America, and Royal Bank of Canada. At closing of the transaction, the combined company is expected to have a pro forma leverage ratio of approximately 3x net debt to adjusted EBITDA. Additionally, Ritchie Bros. will prioritize de-leveraging following the close of the transaction. Ritchie Bros. also intends to maintain its current quarterly dividend of $0.27 per share and will consider future increases as the Company de-levers its balance sheet.

06:20 EST LL Flooring opens three new stores - LL Flooring recently opened three new stores, bringing its total retail footprint to 440 locations across the U.S. The new stores opened in Abilene, Texas; Mundelein, Illinois; and Prescott Valley, Arizona.

06:16 EST Genetron receives listing non-compliance notice from Nasdaq - Genetron has received written notification from the Nasdaq Listing staff indicating that for the last 30 consecutive business days, the closing bid price for the company's ADSs was below the minimum bid price of $1.00 per share requirement. The Nasdaq notification letter has no current effect on the listing or trading of the Company's securities on Nasdaq. The company is provided with a compliance period of 180 calendar days, or until April 26, 2023, to regain compliance. In the event the company does not regain compliance by April 26, 2023, subject to the determination by the staff of Nasdaq, the company may be eligible for an additional 180-day compliance period. The company intends to monitor the closing bid price of its ADSs between now and April 26, 2023 and will take all reasonable measures in order to regain compliance with the Nasdaq minimum bid price requirement.

06:14 EST KBR awarded contract by DFPCL - KBR announced that it has been awarded a contract by Deepak Fertilizers and Petrochemicals Corporation, or DFPCL, to help three DFPCL plants achieve lower emissions and simultaneously increase production capacity. DFPCL is among India's leading manufacturers of industrial chemicals and fertilizers. With a strong presence in technical ammonium nitrate, industrial chemicals and crop nutrition, DFPCL supports critical economic sectors such as infrastructure, mining, chemicals, pharmaceuticals and agriculture.

06:08 EST Choice Hotels sees FY22 adjusted EBITDA $465M-$470M - The company said, "Excluding the impact of Radisson Hotels Americas, domestic RevPAR for full-year 2022 is expected to increase between 13% and 15%, compared to full-year 2019, which represents 11% to 12% growth, compared to full-year 2021."

06:03 EST Ouster, Velodyne Lidar announce proposed merger of equals - Ouster (OUST) and Velodyne (VLDR) announced that they have entered into a definitive agreement to merge in an all-stock transaction. The proposed merger is expected to drive significant value creation and result in a strong financial position through robust product offerings, increased operational efficiencies, and a complementary customer base in fast-growing end-markets. The merger agreement was signed on November 4, 2022. Under the terms of the agreement, each Velodyne share will be exchanged for 0.8204 shares of Ouster at closing. The transaction will result in existing Velodyne and Ouster shareholders each owning approximately 50% of the combined company, based on current shares outstanding. The merger transactions are subject to customary closing conditions including shareholder approval by both companies. Both companies will continue to operate their businesses independently until the close of the merger transactions. The merger transactions are expected to be completed in the first half of 2023.

06:02 EST Peabody Energy, Coronado Global Resources end talks over potential merger - Coronado Global Resources (CRDAF) announced that it has jointly agreed with Peabody Energy Corporation (BTU) to cease discussions regarding a potential combination of the two companies. Coronado said it continues to pursue and implement its existing capital management plans and remains focused on its existing capital investments and long-term development strategy. Reference Link

05:36 EST Daqo New Energy subsidiaries sign five-year polysilicon supply agreement - Daqo New Energy announced that its subsidiaries Xinjiang Daqo and Inner Mongolia Daqo had signed a five-year high-purity polysilicon supply agreement with a leading solar manufacturing company in China. Under the supply agreement, Xinjiang Daqo and Inner Mongolia Daqo will provide this manufacturing company with a total amount of 137,000 MT high-purity mono-grade polysilicon from November to December 2027. Actual prices will be negotiated by both parties monthly according to market conditions.

05:31 EST UMC reports October sales NT$24.34M, up 27.07%

05:17 EST InterDigital awarded funding to support five Horizon Europe 6G research projects - InterDigital announced that it has been awarded funding to support five Horizon Europe 6G Flagship research projects. Specifically, the five flagship projects include 6G-XR, CENTRIC, PREDICT-6G, 6G-BRICKS, and 6G-SHINE, each uniquely dedicated to enabling revolutionary technology advancement and experimental infrastructures in 6G. InterDigital's awarded flagship projects are part of a portfolio of 35 research, innovation, and trial projects curated by the EU's Smart Networks and Services Joint Undertaking to enable the evolution of 5G ecosystems and promote 6G research in Europe. Jointly led by the European Commission and 6G-IA industry association, the SNS JU is responsible for fostering European leadership and technology sovereignty in 6G while boosting 5G deployment across the European continent. The program has allocated upwards of EUR 250M to fund the portfolio of 6G flagship projects.