Stockwinners Market Radar for October 05, 2021 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

18:46 EDT Enbridge CEO: Targeting net zero emissions by 2050 - In an interview on CNBC's Mad Money, Al Monaco said the commercial underpinnings of Enbridge have never been better. The balance sheet is in "tremendous shape" and the company has good financial flexibility, he added. Enbridge has a large renewables business today, Monaco noted. "We're happy with how we're positioning ourselves for the energy transition."

18:19 EDT Bandwidth CEO says mitigation efforts 'proving successful' after DDoS attack - Bandwidth issued a statement in a blog post from CEO David Morken: "On Tuesday, Sept. 28, I posted here to inform you of a DDoS attack aimed at Bandwidth and other providers in the VoIP industry. Here's where we stand now: I'm pleased to report that our mitigation efforts are proving successful. Bandwidth's network has been largely stable and operating at normal service levels since the evening of Sept. 29, although there have been some continued intermittent disruptions. In the midst of some incredibly challenging moments, I have been inspired by the response of our customers. We've had some difficult conversations this past week, but for every tough call, we've had multiple positive, supportive ones. Even as our customers are understandably concerned, we've been moved by the many demonstrations of support we have received. Some of our very largest customers have been at the table with us, fighting shoulder-to-shoulder in unprecedented ways and collaborating with us to defend the ecosystem. We are staying vigilant, and our confidence is growing. First, we will continue to vigorously defend against these attacks. Second, we continue to serve our customers with transparency, candor, and integrity. Some of you may have suffered service impacts as a result of this attack. In every conversation, ticket, and TAC call, we will reinforce that your trust and faith in Bandwidth is deserved. Finally, we will continue to collaborate with our customers and partners to keep the VoIP ecosystem strong. The attackers took advantage of the unique characteristics of real-time communications, as well as the highly interconnected nature of our industry. Our deep collaboration with some of Bandwidth's most intrepid customers and partners allowed us to go on the offensive against the perpetrators in an unprecedented way. Our response to this attack is enhancing the playbook for how to fight back against an industry-wide threat for which there is no off-the-shelf response. We will make every effort to share these learnings in hopes of making our entire ecosystem safer."

18:03 EDT Gol Linhas reports preliminary air traffic figures for September - Gol Linhas announced preliminary air traffic figures for the month of September 2021, compared to the same period in 2020. In the domestic market, demand for GOL's flights increased 36.8% and supply increased by 38.1%. GOL's domestic load factor was 79.1% in September, a 0.8 p.p lower in comparison to September 2020. GOL transported 1.6 million passengers during the month, a 47.8% increase over September 2020.

17:58 EDT Black Hills Colorado Gas reaches settlement agreement for rate review - Black Hills Corp. announced that its Colorado natural gas utility, Black Hills Colorado Gas, Inc., doing business as Black Hills Energy, reached an agreement with parties to its rate review for a general rate increase to support the company's efforts to continue delivering safe and reliable natural gas service to its customers. "I want to thank the Colorado Public Utilities staff, the Colorado Office of Utility Consumer Advocate, Energy Outreach Colorado, and other parties to the settlement for good faith negotiations and coming together on the issues," said Linn Evans, president and CEO of Black Hills Corp. "The ongoing investments reflect our commitment to our Colorado customers for safe and reliable service, support economic growth in the communities we serve, and meet our clean energy goals." The settlement agreement is contingent upon final review and approval by the administrative law judge and Colorado Public Utilities Commission. If approved, the settlement will result in an estimated $6.49M in new annual base rate revenues starting Jan. 1, 2022, to recover Black Hills Energy's investments in utility infrastructure and operating expenses. The new revenue is based on a return on equity of 9.2% and a capital structure of 50.3% equity and 49.7% debt.

17:19 EDT Consensus Cloud Solutions to replace Regis in S&P 600 at open on 10/11 - J2 Global (JCOM) is spinning off Consensus Cloud Solutions (CCSI) in a transaction expected to be effective Friday, October 8. Post spin-off, J2 Global will remain in the S&P MidCap 400. It will change its name to Ziff Davis (ZD) and will change its Global Industry Classification Standard sector to Communication Services.

17:09 EDT Southwest Gas to acquire Questar pipeline from Dominion Energy for $1.545B - Southwest Gas (SWX) announced that it has entered into a definitive agreement to acquire Dominion Energy Questar Pipeline, LLC, its subsidiaries and certain associated affiliates, including Overthrust Pipeline, White River Hub and Questar Field Services from Dominion Energy (D). Under the terms of the transaction, Southwest Gas Holdings will acquire 100% of Questar Pipelines for $1.545B in cash. Southwest Gas Holdings will also assume $430M of Questar Pipelines' debt. The transaction is expected to be accretive to earnings per share in 2022. The transaction is expected to close on or about December 31, 2021. Following the close of the transaction, Questar Pipelines will operate as a standalone subsidiary of Southwest Gas Holdings.

17:02 EDT Scotiabank chief risk officer Moore to leave company - Scotiabank announced that after a 25-year career at the Bank, Daniel Moore, Chief Risk Officer, has made the decision to leave the Bank to pursue other interests. Moore will be taking this opportunity to transition to a strategic advisory role to aid with the transition until the end of the year. Phil Thomas, EVP, Customer Insights, Data & Analytics, has succeeded Moore as Chief Risk Officer. "On behalf of the Board and our entire Leadership Team, I want to thank Daniel for his many contributions to Scotiabank which included key roles as Chief Risk Officer and Head of Global Banking and Markets in Asia-Pacific," said Brian Porter, President and CEO, Scotiabank. "Daniel elevated the Bank's Risk Management function in an evolving environment, and his leadership helped ensure the Bank could navigate the Covid-19 pandemic and support our customers throughout. We are thankful to Daniel for his leadership and impact and wish him continued success in his future."

16:53 EDT Airbnb co-founder Gebbia sells almost $35M in company shares - Airbnb's co-founder Joseph Gebbia disclosed in a regulatory filing that he had sold 204,166 shares of company stock at $171.01 per share on October 1, for a total transaction amount of $34,914,101.

16:33 EDT Chefs' Warehouse acquires Silver State Meats, sees $20M gain in annual sales - The Chefs' Warehouse announced that it has acquired substantially all of the assets of Silver State Meats, based in Las Vegas, Nevada. Since its inception in 2012, Silver State Meats has provided the finest beef, chicken, and pork to the Las Vegas Metro area. "I would like to welcome Paul Unruh and the entire Silver State organization into our growing family of companies," said Christopher Pappas, Chairman and CEO of The Chefs' Warehouse, Inc. "This acquisition offers The Chefs' Warehouse the opportunity to continue to build our all-star team of specialty protein companies that complement our core cultural values. Similar to our organization, Silver State is high-touch, high-quality and committed to excellent service. We look forward to becoming the premier distributor partner for Las Vegas' best chefs." The acquisition of Silver State Meats is expected to generate approximately $20M in annual net sales.

16:32 EDT Asur reports September traffic up 2.6% from 2019 level - Grupo Aeroportuario del Sureste announced passenger traffic for September reached a total of 3.9M passengers, 2.6% above the levels reported in September 2019, reflecting a continued overall recovery in travel demand and the rollout of vaccination campaigns in the US and gradual advances in Mexico, despite restrictions and requirements in certain countries of the world to contain the spread of the virus. When compared to pre-pandemic levels of September 2019, passenger traffic declined 1.1% in Mexico and increased 0.9% in Colombia and 19.9% Puerto Rico. This announcement reflects comparisons between September 1 through September 30 from September 1 through September 30, 2020 and September 1 through September 30, 2019. Transit and general aviation passengers are excluded for Mexico and Colombia.

16:24 EDT Boston Scientific announces results from Ekosonic System clinical trial - Boston Scientific announced positive results for the EkoSonic Endovascular System during a late-breaking clinical trial presentation at the Vascular InterVentional Advances, or VIVA, meeting in Las Vegas. Data from the KNOCOUT PE registry - established to measure institutional adoption of a lower dose and lower-duration thrombolysis protocol for the EKOS system - confirmed the safety and efficacy of the EKOS system for the treatment of patients with intermediate-high and high-risk pulmonary embolism, or PE. The international registry of 489 patients across 83 centers included data from patients treated with the EKOS system who were provided a lower drug dose and shorter infusion duration of a thrombolytic agent than administered in previous studies, reflecting contemporary clinical practice. In the data, there were no intracerebral hemorrhagic events, or brain bleeding events, with a low major bleedingii rate of 2.5%, compared to the rate previously observed with systemic thrombolysis treatment.iii Results also demonstrated a 23% post-procedure reduction in the main indicator of heart strain from PE, measured as right ventricular to left ventricular diameter ratio.

16:19 EDT Calyxt to integrate PlantSpring with its BioFactory pilot bioreactor - Calyxt announced the launch of a strategic initiative that will focus the Company on engineering synthetic biology solutions for a diversified base of customers across an expanded group of end markets including the nutraceutical, cosmeceutical, pharmaceutical, advanced materials, and chemical industries. Central to the strategy is the integration of the Company's proprietary technology platform, PlantSpring, with its newly commissioned pilot bioreactor, the BioFactory, which together will enable Calyxt to rapidly prototype and produce complex plant-derived compounds without the need for outdoor cropping systems.

16:17 EDT iRhythm results show Zio improves health outcomes for 'at-risk' patients - iRhythm Technologies announced the results of the mHealth Screening to Prevent Strokes, mSToPS, study were published today in PLOS One. This clinical research, led by researchers at the Scripps Research Translational Institute, SRTI, was previously presented at the American Heart Association in November of 2020. The mSToPS trial follows the results of the "SCREEN-AF" study, announced earlier in the year, which found that Zio by iRhythm led to a tenfold increase in the detection of AF versus patients receiving standard clinical care. The three-year follow-up of this nationwide study intended to assess whether screening asymptomatic individuals for atrial fibrillation and other arrhythmias with Zio can improve clinical outcomes. The trial was designed to compare outcomes in a combined cohort of 1,718 individuals from eligible Aetna members aged 55 and over who underwent active monitoring and 3,371 matched observational controls. Patients who participated in active monitoring received Zio XT, a long-term continuous monitor, as part of their study enrollment and self-applied the monitor at home while receiving remote support from iRhythm. "iRhythm's vision is to free people from the burden of heart disease," said Quentin Blackford, President and CEO of iRhythm. "The outcomes demonstrated in the study clearly show that screening for AF in at-risk populations can lead to positive patient health outcomes. iRhythm intends to lead the market in commercializing solutions that improve the detection and diagnosis of AF, as well as other significant arrhythmias."

16:14 EDT Thoma Bravo completes acquisition of Stamps.com - Thoma Bravo announced the completion of Thoma Bravo's acquisition of Stamps.com for approximately $6.6B in cash. The acquisition was previously announced on July 9, and Stamps.com's stockholders approved the transaction on September 30. Stamps.com common stock has ceased trading on, and will be de-listed from, the NASDAQ Global Select Market.

16:11 EDT AutoZone announces additional stock repurchase of $1.5B - AutoZone announced its board authorized the repurchase of an additional $1.5B of the company's common stock in connection with its ongoing share repurchase program.

16:08 EDT Allison Transmission developing next-generation electrified transmission - Allison Transmission states that it is "accelerating the development of electrification technology for integration into the U.S. Army's ground combat vehicle fleet including tracked Infantry Fighting Vehicles and the Main Battle Tank... For the Next Generation Electrified Transmission, Allison will design, develop and validate a motor/generator and inverter system to be coupled to a tracked vehicle transmission. Coordination with U.S. Army's Ground Vehicle Systems Center is ongoing and Allison will begin work to accelerate the Next Generation Electrified Transmission program. The Next Generation Electrified Transmission has been selected by American Rheinmetall Vehicles for their OMFV offering. Looking to the future, the U.S. Army is also considering replacing its heavy wheeled vehicle fleets with a Common Tactical Truck, and is considering options for new main battle tanks. These programs are likely to rely on electrification."

16:06 EDT ICF International awarded $31M contract from CDC - The U.S. Centers for Disease Control and Prevention recently awarded ICF a $31M recompete contract to provide development, operations and maintenance support to the agency's nationwide syndromic surveillance platform, BioSense. The contract has a term of four years, including a one-year base and three one-year options.

16:01 EDT General Motors names Edward Kummer as Chief Digital Officer - General Motors named Edward Kummer as Chief Digital Officer, effective October 16. Kummer will be responsible for building and delivering a holistic digital business guided by GM's Growth Strategy, leading a newly formed Digital Business team, and accelerating software investments that will redefine consumer expectations. He will report to GM President Mark Reuss. Kummer was president of Nordstrom Rack's online business and Nordstrom's HauteLook brand, where he led an integrated online site and executed an omni-channel strategy, resulting in increased online sales and significant profit growth. He brings a breadth of expertise leading omni-channel, marketing and digital efforts across multiple industries that have digitally transformed for the benefit of the consumer and business growth, including travel, wealth management, consumer products, retail and entertainment.

15:44 EDT Medtronic updates recall of MiniMed insulin pumps - In an October 5, 2021 update posted to the FDA website, the FDA stated: "Medtronic updated this recall with information that Medtronic will replace any MiniMed 600 series insulin pump that has a clear retainer ring with one that has the updated black retainer ring at no charge. A replacement insulin pump will be provided even if the clear retainer ring is not damaged and regardless of the warranty status of the pump." Reference Link

14:40 EDT Camber Energy trading resumes

14:02 EDT GM to invest in next-generation battery facility in Warren, Michigan - General Motors announced the Wallace Battery Cell Innovation Center, an all-new facility that will significantly expand the company's battery technology operations and accelerate development and commercialization of longer range, more affordable electric vehicle batteries. The Wallace Center will be located on the campus of GM's Global Technical Center in Warren, Michigan. The facility will "play a pivotal role in advancing GM's vision of an all-electric future and help pave the way to widespread adoption of EVs, building on more than a decade of advanced battery development at GM Research and Development," the company said. GM will also use the facility to integrate the work of GM-affiliated battery innovators, helping the company to reach its stated goal of at least 60 percent lower battery costs with the next generation of Ultium. The Wallace Center is currently under construction and will be completed in mid-2022. Designed for expansion, the facility is projected to grow up to at least three times its initial footprint, with room for additional investments, as demand for EVs increases. The facility is expected to build its first prototype cells in the fourth quarter of 2022.

13:48 EDT Ubisoft announces new free-to-play 'Ghost Recon' game - Ubisoft (UBSFY) announced "Tom Clancy's Ghost Recon Frontline," a new free-to-play, massive PvP shooter grounded in the renowned Ghost Recon universe. "Ghost Recon Frontline" will be available on Xbox Series X/S (MSFT), Xbox One, PlayStation 5 (SONY), PlayStation 4, Stadia (GOOG), Luna (AMZN) and Windows PC via Ubisoft Connect, with full cross-play available at launch. Players can register now at ghostreconfrontline.com for a chance to play in early tests and to get the latest news and updates. The first closed test will run from October 14th to October 21st, for PC players in Europe only. Developed by Ubisoft Bucharest, which previously worked on "Ghost Recon Wildlands" and "Ghost Recon Breakpoint," "Ghost Recon Frontline" offers a new way for players to explore the Ghost Recon universe, with a free-to-play, 100+ players, PvP firstperson military experience.

13:35 EDT Facebook says outage triggered by system managing backbone network capacity - Facebook's Santosh Janardhan stated in an engineering blog post: "Now that our platforms are up and running as usual after yesterday's outage, I thought it would be worth sharing a little more detail on what happened and why - and most importantly, how we're learning from it. This outage was triggered by the system that manages our global backbone network capacity. The backbone is the network Facebook has built to connect all our computing facilities together, which consists of tens of thousands of miles of fiber-optic cables crossing the globe and linking all our data centers... The data traffic between all these computing facilities is managed by routers, which figure out where to send all the incoming and outgoing data. And in the extensive day-to-day work of maintaining this infrastructure, our engineers often need to take part of the backbone offline for maintenance - perhaps repairing a fiber line, adding more capacity, or updating the software on the router itself. This was the source of yesterday's outage. During one of these routine maintenance jobs, a command was issued with the intention to assess the availability of global backbone capacity, which unintentionally took down all the connections in our backbone network, effectively disconnecting Facebook data centers globally. Our systems are designed to audit commands like these to prevent mistakes like this, but a bug in that audit tool didn't properly stop the command. This change caused a complete disconnection of our server connections between our data centers and the internet. And that total loss of connection caused a second issue that made things worse... All of this happened very fast... Helpfully, this is an event we're well prepared for thanks to the 'storm' drills we've been running for a long time now... We've done extensive work hardening our systems to prevent unauthorized access, and it was interesting to see how that hardening slowed us down as we tried to recover from an outage caused not by malicious activity, but an error of our own making. I believe a tradeoff like this is worth it - greatly increased day-to-day security vs. a slower recovery from a hopefully rare event like this. From here on out, our job is to strengthen our testing, drills, and overall resilience to make sure events like this happen as rarely as possible." Reference Link

13:02 EDT Xerox acquires Competitive Computing IT services business - Xerox announced it is acquiring Competitive Computing, an IT services business that serves customers throughout New England and the United States. "We're focused on expanding the reach of Xerox IT services to offer our clients automation, digitization, and security to lower operating costs, increase reliability and improve productivity. C2's capabilities and scale will help accelerate our growth, creating new avenues for us to support growth for small and medium sized businesses," said Joanne Collins Smee, chief commercial, SMB and channels officer at Xerox.

12:46 EDT AiPharma to sell assets to Aditx Therapeutics - AiPharma Global Holdings, a company focused on discovering, developing and commercializing antiviral therapies across a broad spectrum of infectious diseases, announced it has entered a binding agreement to sell all of its assets through the sale of one of its wholly owned group subsidaries, to Aditxt.AiPharma holds directly, or through its affiliates worldwide, exclusive rights to Avigan/Reeqonus / Qifenda and all formulations of favipiravir, a broad spectrum oral antiviral drug that targets COVID-19 and other infectious diseases. The binding agreement follows Aditxt's prior announcement on August 25, 2021 to acquire the company and Aditxt's funding of a bridge loan to AiPharma, a key term toward completion of the acquisition, subject to certain closing conditions. The acquisition will form a business segment for Aditxt that is focused on the prevention, treatment, and monitoring of infectious diseases, the companies said in a statement. Alessandro Gadotti, CEO of AiPharma Group commented, "We believe that the combination of Aditxt and AiPharma is uniquely positioned to address the key topics of the COVID-19 pandemic, starting from monitoring of immune status and outpatient treatment for the illness."

12:44 EDT Google announces October 19 Pixel 6 launch event - Google announced an event to launch its Pixel 6 smartphone. The event is scheduled for October 19, 2021 at 10:00 am PT. Reference Link

12:38 EDT Boston Scientific reports 'positive' trial data for Ranger Drug-Coated Balloon - Boston Scientific announced positive results for the Ranger Drug-Coated Balloon during a late-breaking clinical trial presentation at the Vascular InterVentional Advances meeting in Las Vegas. The data included two- year results from the RANGER II SFA randomized controlled trial, confirming the safety and efficacy of the Ranger DCB compared to standard percutaneous transluminal angioplasty for the treatment of patients with peripheral artery disease in the superficial femoral artery and proximal popliteal artery. Following the positive one-year results of RANGER II SFA, which were published in the Journal of American College of Cardiology, the new two-year results found that the Ranger DCB exhibited a significantly higher primary patency rate - a measure of the target vessel remaining unobstructed at two years - of 84.0% compared to 71.4% percent in patients treated with standard PTA. Additionally, subgroup analyses found consistent benefit with greater long-term patency in patients with more complex lesions treated with the Ranger DCB, exhibiting an 89.1% versus 72.4% primary patency rate in the moderate to severe calcium subgroup and a 76.6% compared to a 58.6% primary patency rate in patients with chronic total occlusions. "These two-year data demonstrate a sustained, high rate of efficacy including in patients with more complex lesion subtypes, yet another proof point for physicians to consider when determining the best individualized treatment option for their patients with PAD," said Ravish Sachar, M.D., UNC Rex Hospital physician-in-chief for Heart and Vascular services and principal investigator of the RANGER II SFA trial.

12:03 EDT American National EVP, chief banking officer H. Gregg Strader to retire - American National Bankshares announced that H. Gregg Strader, Executive Vice President & Chief Banking Officer, will retire at the end of 2021 and also announced that two new Executive Vice Presidents & Co-Heads of Banking, Rhonda Joyce and Alex Jung, will succeed him at the Bank. The role of Chief Banking Officer will now be divided among two people to effectively support future growth. Ms. Joyce has been promoted to Executive Vice President & Co-Head of Banking - Commercial of the Bank and Mr. Jung will join the Bank as Executive Vice President & Co-Head of Banking - Consumer & Financial Services. Having joined American National with the Company's acquisition of MidCarolina Bank in 2011, Ms. Joyce has been serving as Regional President, overseeing the Bank's South and North Regions. Jung will be joining American National on November 15, most recently serving as North

12:00 EDT American Realty Investors falls -7.1% - American Realty Investors is down -7.1%, or -95c to $12.35.

12:00 EDT Zurn Water Solutions falls -50.0% - Zurn Water Solutions is down -50.0%, or -$32.45 to $32.50.

12:00 EDT Navios Maritime rises 10.9% - Navios Maritime is up 10.9%, or 55c to $5.60.

11:56 EDT Pennsylvania AG charges Energy Transfer with 46 counts of environmental crimes - Pennsylvania Attorney General Josh Shapiro, in conjunction with the 45th Statewide Investigating Grand Jury, today announced that the Office of Attorney General's Environmental Crimes Section has charged Energy Transfer, L.P., the corporate successor to Sunoco Pipeline L.P., with 46 counts of environmental crimes for their conduct during the construction of the Mariner East 2 Pipeline. Two additional counts were added, after the Grand Jury had concluded, bringing the total to 48 counts based on a criminal referral from Pennsylvania's Department of Environmental Protection. "There is a duty to protect our air and water, and when companies harm these vital resources through negligence - it is a crime," said AG Shapiro. "By charging them, we can both seek to hold them criminally accountable and send a clear message to others about how seriously we take protecting the environment and public health."

11:19 EDT Camber Energy down 27% to $2.25 after Kerrisdale Capital short report - Camber Energy shares were halted for volatility with the stock down 84c, or 27%, to $2.25 following Kerrisdale's report.

11:03 EDT Pennsylvania AG announces charges against Energy Transfer LP - Pennsylvania Attorney General Josh Shapiro announces charges against Energy Transfer LP for alleged crimes involving the construction of the Mariner East II pipeline. Shaprio said in a press conference that his office's investigation is "ongoing." Reference Link

10:02 EDT IZEA reports 181% year-over-year growth in Q3 Managed Services Bookings - IZEA Worldwide announced that it set a Managed Services bookings record for the best quarter in company history. Managed Services bookings in Q3 of 2021 increased 181% year over year to $11.3M as compared to Q3 of 2020, which were $4M. The managed services bookings bests the previous record of $11.1M set in Q2 2021. IZEA added a variety of new influencer marketing customers within the quarter, including multiple Fortune 500 brands.

10:00 EDT Green Dot falls -4.7% - Green Dot is down -4.7%, or -$2.43 to $48.79.

10:00 EDT Li-Cycle falls -5.6% - Li-Cycle is down -5.6%, or -64c to $10.72.

10:00 EDT Navios Maritime rises 8.5% - Navios Maritime is up 8.5%, or 43c to $5.48.

10:00 EDT Zeta Global rises 11.3% - Zeta Global is up 11.3%, or 71c to $7.01.

09:47 EDT StarTek falls -4.1% - StarTek is down -4.1%, or -23c to $5.42.

09:47 EDT Zurn Water Solutions falls -51.3% - Zurn Water Solutions is down -51.3%, or -$33.34 to $31.61.

09:47 EDT Team rises 11.7% - Team is up 11.7%, or 38c to $3.62.

09:44 EDT AB Value urges Rocky Mountain Chocolate shareholders to vote for its candidates - AB Value Management and the other participants representing approximately 14.70% of the outstanding shares of Rocky Mountain Chocolate Factory, remind shareholders to vote the BLUE card: "FOR" the Concerned Shareholders of Rocky Mountain's slate of candidates, consisting of Andrew Berger, Rhonda Parish, Mark Riegel, and Sandra Elizabeth Taylor. AB Value said, "They have the experience and qualifications to implement positive change and best-in-class corporate governance at the Company"; and "FOR" the "Poison Pill Redemption Proposal" to request that the Company's Board of Directors not adopt or extend any poison pill, unless submitted to a shareholder vote within 12 months of such adoption or extension. "Both Institutional Shareholder Services and Glass Lewis & Co. have recognized the need for change at the Company and recommended that shareholders vote the BLUE proxy card and, despite the Board's desperate last-minute decision to terminate the Company's shareholder-unfriendly poison pill following AB Value's years of advocating for its redemption, ISS reaffirmed its recommendation in favor of the Concerned Shareholders of Rocky Mountain," the group said.

09:26 EDT Hyzon Motors says short seller report by Blue Orca 'inaccurate and misleading' - Hyzon Motors issued the following statement in response to a short seller report published on Tuesday, September 28. "The self-serving short seller report published by Blue Orca last week is inaccurate and misleading, and we believe it was intended solely to generate profits on Blue Orca's short position at the expense of Hyzon's long-term shareholders. Hyzon is enjoying market momentum across its business globally, and is focused on executing on the business plan it presented to investors. Hyzon has no record of this short seller ever meeting with Hyzon management, requesting any information or clarification from Hyzon, or otherwise seeking to verify any of its claims, which would have been expected given the inflammatory and grossly inaccurate statements made in the report. We stand by our public disclosures, and we expect Hyzon's performance will speak for itself. Today, Hyzon operates from a position of strength with approximately $500 million of cash and cash-equivalents on its balance sheet to execute on our strategy, and we look forward to discussing a number of promising developments with our investors in our regularly scheduled earnings calls," stated Craig Knight, Hyzon's CEO.

09:18 EDT Genius Brands announces Kartoon Channel! launch on Pluto TV - Genius Brands International (GNUS) announced a deal with Pluto TV, a ViacomCBS Company (VIAC), to stream a branded Kartoon Channel! beginning October 5th, significantly expanding its footprint. Pluto TV's millions of users will now have access to Kartoon Channel!'s program line-up.

09:16 EDT Blink Charging's Blue Mobility expands BlueLA car sharing program - Blink Mobility, a wholly owned subsidiary of Blink Charging, announced the expansion of its BlueLA electric car sharing program serving Los Angeles. Following a Los Angeles City Council vote approving the expansion, Blink will add 300 street side EV charging stations at an anticipated 60 destinations across the city and a progressive increase in the Program's electric vehicle fleet, based on utilization rates. The significant Blink Mobility expansion is funded, in part, through resources provided by the Los Angeles Department of Transportation and California Air Resources Board. Per the expansion agreement, BlueLA powered by Blink Mobility will deploy and operate a total of 500 EV charging stations at a miniumum of 100 locations across Los Angeles. The program will also progressively increase its electric vehicle fleet up to 300 EVs based on utilization rates.

09:15 EDT Berkshire Grey, North Highland partner for enterprise robotic solutions - Berkshire Grey and North Highland announced their partnership to build the next generation of resilient supply chains through intelligent robotic automation of eCommerce fulfillment, store replenishment and package handling. Berkshire Grey will provide North Highland's consulting team access to the most advanced AI-enabled robotic supply chain solutions designed to increase throughput, optimize labor and create a more agile supply chain for eCommerce and retail leaders. With this partnership, North Highland will become part of Berkshire Grey's Partner Alliance program as a Consulting Partner.

09:13 EDT Evolve Transition regains compliance with NYSE America listing standards - Evolve Transition Infrastructure announced it has received written notice from the NYSE American LLC that the Company has regained compliance with continued listing standards outlined in Part 10, Section 1003 of the NYSE American Company Guide. As previously disclosed, the Company received notice from the NYSE American on April 3, 2020 that it was not in compliance with Section 1003(a)(i) of the Company Guide. Subsequently, the Company received notice from the NYSE American on April 29, 2021 that it was not in compliance with Section 1003(a)(ii) of the Company Guide. As a result of management's efforts, the NYSE American has informed the Company that it has regained compliance by meeting the requirements of the $50 million market capitalization exemption from the stockholders' equity requirement in Section 1003(a) of the Company Guide. At the opening of trading on October 5, 2021, the below compliance indicator was no longer disseminated and the Company was removed from the list of NYSE American noncompliant issuers on the NYSE American's website.

09:12 EDT The Brick now fully serving customers across Atlantic Canada - The Brick is pleased to announce that the company is now fully serving customers across Atlantic Canada with the opening of The Brick's first store in St. John's, N.L. and a new distribution centre in Dartmouth, N.S.- the corporation's first facility of its kind in the region. The opening of The Brick's first store in Newfoundland also marks a milestone for the company, as they now have locations in every Canadian province.

09:10 EDT Aware to spotlight identity solutions at Connect:ID 2021 - Aware announced that the company will be speaking in two sessions during this year's Connect:ID conference, taking place from October 5-6 in Washington, DC. Aware executives will be onsite to discuss the benefits of and the role biometric and digital identity technologies will have as more systems and processes continue to move online and access management solutions evolve. Closely aligning with Aware's goal to empower individuals to own their identities through biometrics, this year's Connect:ID conference aims to increase awareness and drive change and widespread adoption of trusted identity solutions.

09:08 EDT Eos Energy announces $25M equipment financing agreement with Trinity Capital - Eos Energy Enterprises (EOSE) announced that HI-POWER, a wholly owned subsidiary of Eos, has entered into a $25M equipment financing agreement with Trinity Capital (TRIN), a provider of debt and equipment financing to growth stage companies. The funds will be used to acquire equipment that will expand production of Eos's proprietary aqueous Znyth batteries. "Securing this equipment financing is a key milestone in our ability to expand our manufacturing capacity and effectively balance our capital allocation strategy," said Sagar Kurada, Chief Financial Officer of Eos. "As we continue to ramp up our manufacturing operations, we expect to have even greater visibility into managing our customer commitment and orders backlog, and improve our delivery lead times."

09:07 EDT NeuroMetrix joins Center to Stream Healthcare in Place as industry partner - NeuroMetrix announced that it has joined the Center to Stream Healthcare In Place as an industry partner. C2SHIP is a U.S. National Science Foundation funded consortium of leading academic centers and industry partners with a mission to develop technologies and approaches for high-quality personalized healthcare that is delivered at-home. The initial four participating academic centers are the University of Arizona, Baylor College of Medicine, University of Southern California and the California Institute of Technology. In this collaboration, NeuroMetrix will focus on novel therapeutic applications of its Quell wearable neuromodulation technology and leveraging the information in the Quell Health Cloud chronic pain database using data science expertise at the participating academic centers.

09:06 EDT Clear Secure's identity technology available at Bradley Airport in LA - Clear announced its identity technology and expedited lanes are now available at the Tom Bradley Terminal of the Los Angeles International Airport. With this expansion, CLEAR's expedited security lanes are now available at all nine LAX airport terminals. This expansion continues CLEAR's growth in California. Earlier this year, CLEAR launched lanes at Oakland and Sacramento international airports. CLEAR's touchless technology uses your eyes to confirm you are you and is now located in 38 airports and with over 130 other partners across US, including sports and entertainment venues. CLEAR is an opt-in membership service that never sells an individual's information.

09:06 EDT Surgalign reports inducement grants under Nasdaq listing rule - Surgalign Holdings announced that it has granted restricted stock unit awards to six employees, none of whom are executive officers, as an inducement for them to accept employment with Surgalign, and representing the right to receive, in the aggregate, up to 86,363 shares of Surgalign common stock. The awards were granted on October 1, 2021 under the Surgalign Holdings, Inc. 2021 Inducement Plan. One-third of the restricted stock units vest on the first anniversary of the date of grant, and one-eighth of the remaining restricted stock units vest on each subsequent quarterly anniversary of the date of grant, such that the award will be fully vested on the third anniversary of the date of grant, subject to continued employment through the applicable vesting date.

09:04 EDT TCR2 Therapeutics presents preclinical data on IL-14 enhanced TRuCs - TCR2 Therapeutics announced the e-poster presentation of new preclinical data at the American Association for Cancer Research Virtual Special Conference on Tumor Immunology and Immunotherapy, taking place October 5-6, 2021. The e-poster titled "Expression of an IL-15 Receptor Fusion Protein Enhances the Persistence of TRuC-T Cells" highlights preclinical data on the Company's proprietary mesothelin-directed T Cell Receptor Fusion Construct T cells that express IL-15-based enhancements as a strategy for improving T cell persistence. The co-expression of these IL-15 enhancements enriched for naive and central memory T cells, upregulated the stemness-associated transcription factor TCF-1 and increased TRuC-T cell proliferation upon repeated stimulation with mesothelin-expressing cancer cell lines. In addition, IL-15 promoted the survival of TRuC-T cells in the absence of T cell receptor (TCR) or exogenous cytokine stimulation. In a mesothelioma xenograft mouse model, IL-15 co-expression resulted in a higher number of TRuC-T cells in the tumor and significantly increased their persistence in peripheral blood. The administration of a single dose of IL-15 enhanced TRuC-T cells cleared tumors in all mice and fully protected them from tumor rechallenge.

09:02 EDT Scientific Games to acquire ACS' PlayOn, terms not disclosed - Scientific Games has signed a definitive agreement to acquire ACS's cashless table game solution titled PlayOn. The PlayOn cashless product line conveniently provides players with a seamless debit solution at live table games. As a part of the Scientific Games portfolio, the ACS PlayOn product line will be called AToM - Access To On Demand Money.

09:02 EDT Intrusion announces Lippert accelerates its INTRUSION Shield deployment - INTRUSION announced that leading supplier to the RV industry Lippert Components has accelerated its deployment of INTRUSION Shield to protect against cyberattacks. Gary Davis, Chief Sales & Marketing Officer of INTRUSION, shared: "Lippert's decision is reflective of the state of most companies today. With roughly 3.5 million unfilled cybersecurity positions and existing teams struggling to address all the alerts being generated today, organizations are being overwhelmed by their cybersecurity products thus distracting them from focusing on other essential tasks. Using Shield to identify and kill malicious connections without generating alerts goes a long way towards addressing this challenge."

09:00 EDT Dolby upgrades Dolby.io developer platform - Dolby Laboratories announced milestones for Dolby.io, a media and communications platform that enables businesses, developers and content creators to enhance real-time interactions and any piece of content in order to deliver spectacular audiovisual experiences in their apps and services. In addition, Dolby.io today introduced new capabilities in the form of the Transcode and Music Mastering APIs, as well as a desktop Communications SDK.

08:56 EDT Guardant begins study to evaluate Guardant Reveal in predicting cancers - Guardant Health has initiated the Observation of ResiduAl Cancer with Liquid biopsy Evaluation, ORACLE, study, a 1,000-patient prospective, observational, multi-center study designed to evaluate the performance of its Guardant Reveal liquid biopsy test to predict cancer recurrence after curative intent treatment, across 11 solid tumor types. "For oncologists managing patients with early-stage cancer, there is a need for additional tools to help make informed decisions regarding risk for recurrence and benefit of adjuvant therapies, and avoid under- or over-treatment," said Craig Eagle, MD, Guardant Health Chief Medical Officer. "This study is exciting because it will evaluate the first blood-only minimal residual disease ++ assay in additional tumor types, and set the stage to identify opportunities for this technology to improve patient care." The study will analyze circulating tumor, ctDNA, status from blood samples of patients with early-stage cancer, using the Guardant Reveal test after the end of treatment, and during routine follow-up. Participants will be followed until distant recurrence, or up to five years. The ORACLE study adds to currently underway clinical studies evaluating the performance of the Guardant Reveal blood test in patients with early-stage cancer. "Initiating this study adds to the growing body of evidence that will support the expansion of the Guardant Reveal blood test from its first indication of early-stage colorectal cancer to multiple cancer types. We believe our blood-only test can be a powerful and streamlined decision-making tool for oncologists managing patients with early-stage cancers," said Helmy Eltoukhy, Guardant Health Co-CEO. "The ORACLE study exemplifies our commitment to further demonstrating the utility of our blood tests to improve long-term clinical outcomes."

08:51 EDT CPI Card Group announces Amintore Schenkel as CFO - CPI Card Group (PMTS) announced that Amintore Schenkel has joined the Company as Chief Financial Officer. Prior to leading his own consulting business, Schenkel served as Senior Vice President, Chief Accounting Officer and Controller of Western Union (WU) from 2006 to 2020.

08:48 EDT Crowdstrike, UiPath team 'on new level of security protection' - UiPath (PATH), an enterprise automation software company, and CrowdStrike (CRWD), a company that provides endpoint and workload protection announced that the companies have partnered "to deliver a new level of security protection and visibility with the UiPath Robotic Process Automation, RPA, platform and the UiPath . "Together, CrowdStrike and UiPath automatically detect threat activity, whether initiated by humans or robots, to grant the security team real-time visibility across the environment and enable proactive responses," the companies announced.The ability to quickly and easily distinguish between an RPA-initiated process and a human-initiated process will provide security teams with real-time visibility across the environment for proactive threat hunting, incident investigation and remediation. "CrowdStrike and UiPath together bring unparalleled capabilities to the market to mitigate potential risk and increase the visibility of the security organization into robot-led activities," said Amol Kulkarni, CrowdStrike chief product officer. As automation becomes a core part of the enterprise technology stack and protecting against threats becomes more complex, strengthening our joint customers' security posture will positively impact their business outcomes, said the companies in a statement" "RPA is extending further across the enterprise to automate more processes, making it a fundamental operational asset that companies must protect," said Ted Kummert, executive vice president of products and engineering at UiPath. "The challenge of keeping companies, customers and employees safe increases every day. By partnering with CrowdStrike's leading cloud-based security technology, our customers gain the unique advantage of a highly secure and easy to implement end-to-end automation platform."

08:47 EDT Victory Square's VS Digital Health launches affiliated network - Victory Square Technologies announced that its wholly owned portfolio company, VS Digital Health is now affiliated with a national network of professional corporations. These affiliated medical practices contract with licensed medical providers and exert full and exclusive control over the professional clinical services rendered by the providers. In turn, VS Digital Health provides administrative and management services and technology solutions to these affiliated PCs. The company said highlights include, "New affiliation with friendly PCs adopted as Company ramps up for major expansion across the United States. The affiliation between VS Digital Health and the friendly PCs will enable customers to benefit from the relationship model created by VS Digital Health. The structure of the affiliation is designed to enable everyone, not just licensed medical professionals, to participate in the exclusive VS Digital Health business in a legally and fully compliant manner."

08:42 EDT SmileDirectClub allowed new patent for SmileBus concept - SmileDirectClub announced the United States Patent & Trademark Office will issue a patent on the company's SmileBus concept. "SmileDirectClub's investment in its SmileBus fleet and its SmileBus concept, which the USPTO recognized as novel, underscores its commitment to its mission of increasing access to oral care. The patent will further strengthen protection for SmileDirectClub's intellectual property as one of the methods for bringing premium, affordable, accessible oral care to more people through its telehealth platform," the company said. This newest patent will join the company's intellectual property portfolio, which includes SmileDirectClub's patent-protected and innovative digital customer journey, groundbreaking advancements in the manufacture of clear aligners, award-winning whitening system and many other premium oral care offerings.

08:39 EDT Altor Solutions announces acquisition of Plymouth Foam - Altor Solutions, a subsidiary of Compass Diversified, announced that it has acquired Plymouth Foam, a manufacturer of protective packaging and componentry, for an enterprise value of $56M, excluding customary closing adjustments. "This transaction strengthens Altor's status as a leading provider of packaging and componentry solutions through an expanded geographic presence, the addition of capabilities in componentry design and the cold chain sector and access to a broader base of clients across a wide variety of end-markets, including food and beverage, pharmaceuticals, recreational vehicles and construction," the company said. "This transaction builds on a period of growth and momentum that began with our rebranding to Altor Solutions earlier this year," said James Hughes, CEO of Altor. "We believe that the acquisition of Plymouth, with its wide array of high-value, highly engineered products, further expands our business and capabilities. With access to Plymouth's diversified client base, two well-placed manufacturing facilities, complementary expertise and talented team, we are confident we will significantly expand Altor and Plymouth's combined reach throughout the country. We are pleased to welcome Plymouth's impressive team and look forward to capitalizing on the strengths of both companies as we deliver the best solutions for our growing customer base."

08:38 EDT Genasys announces follow-on GEM software services contract with automaker - Genasys announced a follow-on enterprise software services contract with a major automobile manufacturer for its operations in a Latin American country. Genasys Emergency Management software services replaced a competitor's system and went live at multiple locations on September 30.

08:37 EDT Zymeworks, ALX Oncology dose 1st patient in Zanidatamab-ALX148 trial for cancer - Zymeworks Inc. (ZYME), and ALX Oncology (ALXO) announced the first patient has been dosed in an open-label, multi-center Phase 1b/2 clinical trial conducted by Zymeworks. The trial is designed to evaluate the safety and efficacy of zanidatamab, Zymeworks' lead HER2-targeted bispecific antibody, in combination with evorpacept , ALX's CD47 blocker, in patients with advanced HER2-positive breast cancer, HER2-low breast cancer and additional non-breast HER2-expressing solid tumors. This collaboration builds on the promising antitumor activity observed in clinical trials of evorpacept combined with a HER2-targeted antibody in patients with advanced HER2-positive gastric or gastroesophageal junction cancer. The addition of CD47 blockade is designed to enhance zanidatamab's immunotherapeutic effects and has the potential to provide benefit to a broad population of patients, including those with advanced HER2-expressing breast cancer and potentially other HER2-expressing cancers.

08:36 EDT Metromile selected by Buckle to power FNOL process - Metromile Enterprise Solutions announces that Buckle, a tech-enabled financial services platform, has chosen Metromile REPORT for digital first notice of loss, FNOL, services. REPORT is Metromile's digital, contextual, self-service FNOL solution for customer-facing data collection and customer service agents. "Like Buckle, we believe that the economy is changing, and insurance products and services should be built to address the future: digital first and meeting customers where they live, work, and play," said Metromile Enterprise General Manager Amrish Singh. "Rideshare and delivery drivers are highly valued contributors to the economy, and we're proud that Metromile's technology will help Buckle improve the claims process for them." Through REPORT, rideshare and delivery drivers who have an accident can quickly file a claim and upload photos and documentation directly from the device of their choice.

08:33 EDT Phunware announces new PhunWallet release, 10M PhunToken Sweepstakes - Phunware announced a Ten Million PhunToken Sweepstakes in conjunction with a new release of PhunWallet on Apple iOS and Google Android and an updated PhunWallet roadmap in support of its blockchain-enabled Customer Data Platform and Mobile Loyalty Ecosystem.

08:33 EDT Invictus provides details term sheets to CSU for $150M financing transaction - Invictus Global Management, one of the largest shareholders of Capital Senior Living, or CSU, provided detailed term sheets to CSU for a market-based $150M financing transaction that contain terms far superior to those offered by Conversant Capital. Invictus also sent an open letter to Kimberly Lody, the President and CEO of CSU, summarizing the term sheets and urging CSU to engage with Invictus. "Invictus stands ready, willing and able to provide capital to CSU on terms that reflect the Company's high-quality asset base, the strength of its underlying business and the primacy that should be afforded to existing shareholders," said Amit Patel, Partner, Invictus. "The Conversant transaction, by contrast, contains egregious terms that are completely off market, highly dilutive to shareholders and value destructive. We highly doubt that shareholders will support those terms. And when the Conversant deal is rejected, we will welcome the opportunity to provide capital to CSU on the terms outlined in today's letter and term sheets and we will fully embrace the participation of our fellow shareholders."

08:31 EDT Skye Bioscience appoints Kaitlyn Arsenault as Chief Financial Officer - Skye Bioscience has appointed Kaitlyn Arsenault, CPA, as Chief Financial Officer. Arsenault brings over 14 years of experience in accounting, auditing, financial reporting, mergers and acquisitions, as well as business operations in the life science and technology sectors. Prior to her appointment as CFO of Skye, she served as an independent consultant for emerging public and private companies, including Skye for the past six years.

08:26 EDT HTG Molecular expands therapeutics team - HTG Molecular Diagnostics (HTGM) announced it has expanded its therapeutics team with the addition of professionals. Stephen Barat has been named HTG's Senior Vice President of Therapeutics. Also joining the company are Todd Huffman, Ph.D. as Vice President of Strategy, Carl Kaub as Vice President of Chemistry Operations and Desmond Raitt, Ph.D. as Vice President of Business Development. Prior to joining HTG, Barat was the U.S. Head, Non-clinical Safety Leaders in Non-clinical Safety Assessment at Janssen (JNJ), where he led a large team that supported programs in all phases of discovery and development. Before joining HTG, Huffman co-founded Padlock Therapeutics. Kaub was Senior Director of Business Development and Operations at WuXi AppTec (WUXIF). As Co-founder and Chief Executive Officer of Seal Biosciences, Desmond Raitt negotiated an exclusive license from the University of California in San Francisco and led strategic partnering and fundraising activities for a novel anti-EGFR response biomarker to improve patient outcomes in metastatic colorectal cancer.

08:25 EDT Quad/Graphics names Dave Honan COO, Tony Staniak CFO - Quad/Graphics announced it will promote Dave Honan to Chief Operating Officer from Chief Financial Officer, and Tony Staniak to Chief Financial Officer from Vice President of Finance. This announcement, part of a planned executive transition process, precedes the retirement of current Chief Operating Officer Tom Frankowski, who will depart Quad on December 31 after a 42-year career with the Company. Tom Frankowski will retire at year-end 2021 after four decades of building Quad into a premier company - first as a commercial printer and, more recently, as a marketing solutions partner. Honan and Staniak assume their new roles on January 1, and will use the next three months to ensure a seamless transition of responsibilities.

08:22 EDT Eloxx Pharmaceuticals secures up to $30M debt facility from Hercules Capital - Eloxx Pharmaceuticals (ELOX) announced that the company has entered into a debt facility of up to $30M with Hercules Capital (HTGC). Eloxx has drawn the initial tranche of $12.5M and used the proceeds to repay in full amounts outstanding under the Company's existing debt facility. The remaining funds under the new facility will be available in additional tranches upon the achievement of specific clinical milestones or other terms and conditions.

08:21 EDT PepsiCo 'not ready' to get into specific details of FY22 guidance

08:21 EDT PepsiCo sees organic revenue, core EPS in line with long-term objectives in 2022 - Comments taken from Q3 earnings conference call.

08:17 EDT VirTra receives $1.3M order from country in Europe - VirTra has received a $1.3M order from a federal law enforcement agency in a European country for use-of-force simulators, weapon recoil kits and other training accessories. The purchase order includes the delivery of multiple V-ST PRO 4K simulators, authoring software, Threat-Fire, weapon recoil kits, TASER training cartridges and other tools designed for simulator use. "Having another European country benefit from our life-saving technology further expands our goal of supporting law enforcement worldwide," said VirTra CEO and Chairman Bob Ferris. "By providing a multitude of tools to this client, the federal agency will be able to train with every tool on their belt in a safe environment to be better prepared in the field." The products will be delivered and installed soon in three different locations across the country. As part of the installation, the clients will receive training on system and hardware operation.

08:16 EDT Proxy firms ISS and Glass Lewis support NextGen Healthcare director nominees - NextGen Healthcare announced that leading independent proxy advisory firms, Institutional Shareholder Services ISS and Glass Lewis have recommended that NextGen Healthcare shareholders use the company's white proxy card and vote for among other proposals: The reincorporation of the Company to Delaware; The elimination of cumulative voting in the election of directors; and The election of each of NextGen Healthcare's director nominees. "These two recent additions, David Sides and Sri Velamoor, to the executive team have expressed a vision for how the company will execute the next stage of its strategy, and further disruption in the boardroom may jeopardize the potential for success." "Recent additions to the executive team may finally help to deliver the revenue growth that has consistently been on the horizon," said ISS. Both ISS's and Glass Lewis's recommendations further validate our belief that efforts to revitalize the Company are working and that NextGen Healthcare is poised for accelerating growth and shareholder value creation.

08:15 EDT Worksport enters joint collaboration with Greatcell Solar Italy - Worksport announced that it has entered into a joint collaboration with Greatcell Solar Italy. The company said, "Worksport's commitment to decarbonizing transportation is attracting the best of the best in complementary companies that hold a similar vision: to shift consumer mindsets toward grid-independent technology solutions. Worksport partners with industry-leading solar providers for flexible, high efficiency, mono-crystalline panels for their Terravis systems, currently available for pre-order. Management believes the inaugural Terravis solar cover and COR energy storage system will establish a very loyal market, one that will look forward to next-generation technological enhancements across the Company's product lines. And this is precisely why the Company is excited to partner with Greatcell, a Top 3 Global Innovator in Perovskite Solar Cell technology."

08:14 EDT PureTech Health entity announces VE303 trial met primary endpoint - PureTech Health noted that its founded entity, Vedanta announced that its Phase 2 clinical trial of VE303, an orally administered investigational live biotherapeutic product in development for the prevention of recurrent C. difficile infection, or CDI, in high-risk patients, met its primary endpoint of preventing disease recurrence through Week 8. VE303 achieved a 31.7% absolute risk reduction in rate of recurrence when compared with placebo, representing a greater than 80% reduction in the odds of a recurrence. This is the most advanced clinical trial of an investigational drug based on a rationally defined bacterial consortium, a microbiome-based therapeutic approach that delivers orally administered candidates of precisely known composition that can be manufactured with pharmaceutical-grade consistency. The positive results of the Phase 2 study triggered a $23.8M contract option from the Biomedical Advanced Research and Development Authority, or BARDA, part of the HHS Office of the Assistant Secretary for Preparedness and Response, to support a Phase 3 clinical trial of VE303, which Vedanta plans to initiate in 2022. of treatment with standard-of-care antibiotics for recurrent CDI or for a primary CDI episode with one or more characteristics that placed those patients at high risk of recurrence. The trial evaluated low-dose VE303, high-dose VE303 and placebo. Following completion of their standard-of-care antibiotic treatment for CDI, trial participants were randomized to one of the 3 groups and dosed once daily for two weeks. Trial participants were followed for a total of 24 weeks, to monitor for long-term safety, colonization dynamics, and additional recurrent CDI episodes. The primary objective of the trial was to establish a dose regimen for a potential Phase 3 clinical trial, based on the safety and efficacy of the VE303 regimens compared with placebo. The primary efficacy endpoint of the trial was the CDI recurrence rate in each of the three groups within eight weeks after the start of dosing. At eight weeks, efficacy outcomes were assessed for 78 patients: 29 from the high-dose group, 27 from the low-dose group, and 22 from the placebo group. The topline efficacy results are based on a prespecified analysis conducted after all patients had reached the Week 8 visit, using the intent-to-treat population. The high dose of VE303 met the primary endpoint of a lower recurrence rate within 8 weeks versus placebo using a prespecified analysis that incorporated the results of toxin and PCR testing, or a clinician's diagnosis and treatment of a CDI recurrence when no stool sample was available for testing. This 31.7 percent reduction in absolute risk of recurrence reflects a greater than 80% reduction in the odds of a recurrence in the high-dose group compared with the placebo group. Through the Week 8 timepoint, the proportion of these high-risk patients remaining recurrence-free in the high-dose cohort was 86.2%, compared with 54.5% of the placebo recipients remaining recurrence-free at that timepoint. Using C. difficile toxin testing alone to define recurrence, which has been historically reported to miss 20% to 50% of CDI cases, was not a robust enough analysis to demonstrate a statistically significant difference between either of the active treatment groups and the placebo group. Overall, VE303 was observed to be generally well-tolerated in the trial. Most participants reported one or more adverse events, but in similar proportions across groups. Few serious adverse events were reported in the trial, and none were determined to be treatment-related by either the trial investigators or Vedanta. The final results and statistical analysis will be available following completion of long-term safety follow-up and locking of the complete trial database. Vedanta intends to present the final data analysis at a future medical conference. Based on the Phase 2 data, BARDA has exercised its first contract option for additional funding of $23.8M pursuant to its existing 2020 contract with Vedanta. Total committed funding under the BARDA award to date is $31.2M, inclusive of this first contract option. The contract provides for reimbursement of up to $76.9M, subject to additional prespecified milestones being achieved and the availability of funding.

08:11 EDT H2O Innovation wins water reuse project, two First Nations projects - H2O Innovation is pleased to announce that it has recently won a water reuse project in California, two First Nations projects in Canada and another small-scale one. These contracts, with a total value of $9.9 M, bring the Water Technologies & Services backlog to $41.2 M. H2O Innovation will be supplying a water reuse system for a major client located in Escondido, California. This project will incorporate ultrafiltration system followed by reverse osmosis. The UF will be designed to have a net filtrate production capacity of 2.5 MGD, while the RO has a permeate capacity of 2.0 MGD. The system will treat tertiary effluent from the existing recycled water system to produce high purity recycled water that will be blended with the existing recycled water supply and used for agricultural irrigation. The Corporation was also awarded the design and supply of a membrane bioreactor system with an average day flow of 50,000 gpd for the Dene Tha' First Nation in Northern Alberta. In addition to the supply of equipment, H2O Innovation will provide extensive training for the operations team at the customer's site and an extended service contract to support the team for five years after the plant goes online. The third project involves the design and supply of a 457,000 gpd membrane system treating surface water for a First Nation community located on the north shore of Gouin Reservoir in Quebec. The scope of supply incudes pretreatment through multimedia filtration, followed by nanofiltration trains, and ultraviolet radiation for disinfection. The treatment process will provide exceptional drinking water quality by removing all suspended matter and most dissolved organics. The Corporation will also provide a service contract for plant operation including remote monitoring with data acquisition and system analysis to ensure reliable operation and optimal treatment performance.

08:10 EDT Certara appoints Drayton Virkler as Chief Commercial Officer - Certara (CERT) announced the appointment of Drayton Virkler to the newly created position of Chief Commercial Officer. In this role, Virkler will drive the Company's global commercial strategy and execution and expand the business development team. Virkler was most recently at IQVIA (IQV) for a decade, where he served as Vice President and Global Head of Sales for the Real World Solutions Global Business Unit.

08:09 EDT MarineMax MarineMax to acquire Intrepid, sees accretion in first full year - MarineMax that it has entered into a definitive agreement to acquire Intrepid Powerboats a manufacturer of powerboats. MarineMax expects the acquisition to close before December 31, and to be accretive in its first full twelve-month period. "Intrepid Powerboats is recognized as a world class producer of customized boats, carefully reflecting the unique desires of each individual owner. Based in Largo, Florida,," said the company in a statement. W. Brett McGill, Chief Executive Officer and President of MarineMax, stated, "The strategic acquisition of Intrepid Powerboats allows us to provide Intrepid with additional resources to expand and to enhance how it serves their extremely loyal customer base. We believe we can help grow the Intrepid brand by leveraging our digital technologies, capital and other resources. This accretive acquisition aligns with our long-term strategy of adding quality businesses to our portfolio and implementing best practices to support the expansion of our gross margins."

08:08 EDT DSS issued new CUSIP number in conjunction with previously announced name change - DSS announced, in conjunction with its previously announced name change to DSS, its stock began trading under a new CUSIP number, 26253C 102, effective with the opening of trading on October 1, 2021. The company's stock will continue to trade under its current ticker symbol, DSS. "It has been two years since we embarked on a significant corporate transformation with the goal of positioning DSS for long-term shareholder value improvement," commented Jason Grady, COO of DSS. "We have added multiple new divisions in exciting, high-growth markets, from digital assets to healthcare, real estate, renewable energy, and more. Our name change is yet another milestone in this evolution and signifies the next chapter for DSS as we focus our efforts on expanding and deepening each of our business lines."

08:07 EDT Honey introduces cash back through PayPal - Honey announced the introduction of cash back through PayPal, a new option for U.S. users to redeem Honey Gold reward points earned while shopping online. Users who link their Honey and eligible PayPal accounts will be able to redeem Gold points for cash through PayPal, providing more choices to save and spend how they want.

08:06 EDT Braemar Hotels & Resorts reports September portfolio occupancy 56.4% - Braemar Hotels & Resorts reported preliminary portfolio occupancy of 56.4% for the month of September with an average daily rate, or ADR, of approximately $333 resulting in RevPAR of approximately $188. This RevPAR reflects an approximate increase of 166.7% versus September 2020 and a decline of approximately 20.8% versus September 2019. The Company expects to report occupancy of 61.7% for the Q3 with an ADR of approximately $357 resulting in RevPAR of approximately $220. This RevPAR reflects an approximate increase of 172.4% compared to the Q3 of FY20 and a decline of approximately 6.5% compared to the Q3 of 2019. "September's results appear to have fallen somewhat short of our initial expectations due to market concerns about the COVID-19 Delta variant. However, daily cases appear to be declining and we are optimistic that the momentum we have experienced in our operating performance will continue," said Richard J. Stockton, Braemar's President and CEO. "Our Napa properties continue to be strong performers. In the month of September, Bardessono Resort and Spa and Hotel Yountville lead the portfolio in ADR, achieving $1,440 and $996, respectively. Looking ahead, we believe Braemar is well-positioned to continue to execute on its disciplined strategy for growth."

08:06 EDT Visteon, BlackBerry expand partnership on digital cockpit solutions - Visteon (VC) and BlackBerry (BB) announced an expansion of their collaborative work to accelerate the deployment of digital cockpit solutions for automakers and suppliers around the world. As part of the multi-year agreement, Visteon will use a range of BlackBerry QNX software and services to build next generation digital consolidated cockpits, including infotainment systems, digital instrument clusters, and telematics systems for multiple auto manufacturers.

08:05 EDT VYNE says China partner enrolls first patient in Phase 3 study of AMZEEQ - VYNE Therapeutics announced that the first patient has been enrolled in a Phase 3 study in China evaluating AMZEEQ topical foam, 4% in moderate to severe acne. The study is being conducted by the Company's partner, Cutia Therapeutics, for the purposes of seeking regulatory approval for AMZEEQ in China. The study is a multicenter, randomized, double-blind, vehicle-controlled Phase III study to evaluate the efficacy and safety of topical administration of minocycline topical foam, 4% in the treatment of moderate-to-severe acne vulgaris. It is expected to enroll 372 patients at approximately 29 sites in China. The primary endpoint for the study is the absolute change from baseline in inflammatory lesion count at Week 12, while a key secondary endpoint is IGA endpoint success at Week 12, where success is defined as an IGA score of 0 or 1, and at least a 2-grade improvement from baseline. In April 2020, VYNE entered into a licensing agreement with an affiliate of Cutia Therapeutics, a dermatology-focused company based in Shanghai, China. Under the terms of the agreement, Cutia has an exclusive license to obtain regulatory approval of and commercialize AMZEEQ, ZILXI and its FCD105 product candidate, once approved, in greater China. The Company is eligible to receive royalties on net sales of any licensed products.

08:04 EDT Ashford Hospitality reports preliminary portfolio occupancy 59.7% for September - Ashford Hospitality Trust reported preliminary portfolio occupancy of 59.7% for the month of September with an average daily rate of approximately $158 resulting in RevPAR of approximately $94. This RevPAR reflects an approximate increase of 145.0% versus September 2020 and a decline of approximately 28.2% versus September 2019. The company expects to report occupancy of 62.8% for the third quarter of 2021 with an ADR of approximately $156 resulting in RevPAR of approximately $98. This RevPAR reflects an approximate increase of 165.7% compared to the third quarter of 2020 and a decline of approximately 25.6% compared to the third quarter of 2019.

08:02 EDT PetVivo engages Joe Manning as Senior Technical Veterinarian - PetVivo announces that Joe Manning, DVM has been engaged to work with the company as a Senior Technical Veterinarian. Manning has more than 30 years of veterinary experience in the Animal Health Industry holding various roles as a practicing veterinarian, as well as a contributor in product development and commercialization of therapeutic veterinary products.

08:01 EDT Alaska Air announces codeshare agreement with Iberia Airlines - Alaska Airlines further expanded its global reach with the announcement of a new codeshare agreement with Iberia Airlines, a fellow member of the oneworld alliance. The agreement further strengthens the existing partnership between the two airlines by providing flyers with exciting and convenient travel options. The agreement allows passengers on Iberia to book travel and easily connect to more than 40 routes throughout Alaska's network for travel on or after October 7.

07:56 EDT Tesla VP of People says 'facts don't justify' jury verdict in harassment case - Valerie Capers Workman, VP People at Tesla, stated in a post to the company's blog: "Earlier today, a jury in San Francisco decided that in late 2015 and early 2016 Tesla failed to make sure that one contract employee (Owen Diaz) was not racially harassed while he worked at the Tesla Fremont factory... While we strongly believe that these facts don't justify the verdict reached by the jury in San Francisco, we do recognize that in 2015 and 2016 we were not perfect. We're still not perfect. But we have come a long way from 5 years ago. We continue to grow and improve in how we address employee concerns. Occasionally, we'll get it wrong, and when that happens we should be held accountable... We acknowledge that we still have work to do to ensure that every employee feels that they can bring their whole self to work at Tesla. And as I posted in July, we will continue to remind everyone who enters the Tesla workplace that any discriminatory slurs - no matter the intent or who is using them - will not be tolerated." Reference Link

07:39 EDT Nouveau Monde commissions lab, hires scientists, amid battery R&D expansion - Nouveau Monde Graphite is completing the commissioning of its state-of-the-art laboratory at its demonstration plant, an addition to the Company's existing quality testing facilities. This expansion is triggered by Nouveau Monde's commitment to catering to the market's requirements for high-performing and environmentally responsible battery materials that can be tailored to a variety of specifications for electric vehicles and energy storage usage. and Mr. Neel Rahem, to complement its strong internal technical team consisting of six Doctorate recipients, three Master of Scienc holders, and 18 engineers with previous hands-on experience with leading graphite operators including Imerys, SGL Group and BTR New Material and specialists in the fields of lithium-ion batteries , carbon materials, bi-polar plates, electrochemistry, and engineered advanced materials.

07:37 EDT Otonomo Technologies acquires Neura, expands portfolio - Otonomo Technologies announces that it has acquired Neura, a company that works on AI-powered Mobility Intelligence. Otonomo acquired 100% of Neura outstanding equity interests. "Otonomo expects this acquisition to expedite Otonomo's growth and to contribute positively to Otonomo's revenue moving forward. Otonomo's newly expanded mobility intelligence platform will leverage Neura's advanced analytics powered by patented Artificial Intelligence and Machine Learning technologies, and diverse multi-layered data," the company said. In addition, Otonomo announced the launch of new solutions, leveraging Neura technologies, that will provide transportation planners, EV service providers, MaaS providers, fleets and others, with the actionable multimodal and mobility insights required for the effective planning and operation of expedient and sustainable transportation networks. "The acquisition of Neura reinforces Otonomo's leadership in the mobility, transportation and automotive data space," said Ben Volkow, CEO and Co-Founder, Otonomo. He continued, "In response to our customer and market needs, we can now provide increased value and the required deeper and a more holistic view of mobility. Otonomo is excited to expand its portfolio of SaaS offerings to include vertical specific intelligence solutions. This elevates the Otonomo platform into an impactful solution for the wider mobility, transportation and automotive industries."

07:36 EDT Cathie Wood's ARK Investment bought 167K shares of Twitter on Monday

07:34 EDT Zai Lab announces study of margetuximab in China met primary endpoint - Zai Lab (ZLAB) announced that the bridging study of margetuximab plus chemotherapy in advanced, previously treated HER2+ breast cancer met its primary endpoint, with acceptable safety and tolerability. The study showed that efficacy of this combination in Chinese patients was consistent with that seen in the global population in the SOPHIA trial conducted by Zai Lab's partner MacroGenics (MGNX). The study was a randomized, open-label, multi-center, Phase II clinical study to evaluate the efficacy and safety of margetuximab plus chemotherapy compared with trastuzumab plus chemotherapy in 123 Chinese patients in mainland China, Hong Kong, and Taiwan with advanced HER2+ breast cancer who had received at least two prior lines of anti-HER2-directed therapy in the metastatic setting, including trastuzumab. The primary endpoint of the study was median progression-free survival, mPFS, evaluated by blinded independent central review as defined by the achievement of at least 50% of the efficacy of margetuximab plus chemotherapy in the SOPHIA study. The secondary endpoints included overall survival, mPFS evaluated by investigator, and objective response rate. In this study, the hazard ratio, HR, for PFS in the intent-to-treat population evaluated by BICR was 0.69 favoring the margetuximab combination, thus achieving the primary endpoint. The safety profile of margetuximab plus chemotherapy was acceptable and consistent with the safety profile of margetuximab plus chemotherapy seen in the SOPHIA trial. Zai Lab is planning to present the detailed study results at an upcoming medical conference. Based on these positive results, Zai Lab expects to file a BLA in China for this indication by approximately year end 2021.

07:34 EDT Par Technology names Raju Malhotra CPTO - PAR Technology announced that Raju Malhotra has been named Chief Product & Technology Officer CPTO of PAR Technology Corporation. Mr. Malhotra was formerly the CPTO at Punchh Inc., which was acquired by PAR in April 2021. "We're honored to appoint Raju as CPTO of PAR. Raju's background is beyond impressive and in our short while working together, he's exceeded all expectations," said Savneet Singh, CEO of PAR Technology. "We could not be happier to welcome Raju aboard as we continue to revolutionize how restaurant technology meets the needs of our customers. Raju will lead the connection and development of the PAR platform, as we remain a strong ally to the restaurant industry by bringing together disparate solutions, products and integrations."

07:33 EDT SunPower acquires Blue Raven Solar for $165M - SunPower announced it acquired Blue Raven Solar, a residential solar provider. Blue Raven's growth trajectory and complementary geographic footprint is expected to provide SunPower a path to quickly expand the solar market to serve more customers in underpenetrated areas including the Northwest and Mid-Atlantic regions. The acquisition was made for cash consideration of up to $165M. Blue Raven CEO Ben Peterson will join SunPower's executive team, and the company expects to build upon Blue Raven's current employee and contractor relationships. In addition, SunPower expects that Blue Raven's volume will help expand its comprehensive suite of financial products and increase 2022 loan volume significantly.

07:32 EDT Biohaven Pharmaceutical sees Q3 NURTEC ODT net product revenue $136M - Biohaven Pharmaceutical announced preliminary net product revenue of NURTEC ODT for the third quarter. Based on preliminary unaudited financial information, the company reported $136M in net product revenue from sales of NURTEC ODT in the third quarter. Total prescriptions of NURTEC ODT from product launch to date (as of September 30, 2021) were over 1,000,000, with approximately 46,000 unique prescribers.

07:25 EDT Bonanza Creek announces offering of $400M new senior notes - Bonanza Creek Energy announced that, subject to market conditions, it intends to offer $400M in aggregate principal amount of senior unsecured notes due 2026 in a private placement to eligible purchasers under Rule 144A and Regulation S of the Securities Act of 1933, as amended. Bonanza Creek expects to use the net proceeds from the Offering, together with cash on hand, to repay all borrowings outstanding under the CPPIB Crestone Peak Resources America credit facility, to repay borrowings under Bonanza Creek's credit facility and for general corporate purposes. The Notes will be subject to a "special mandatory redemption" in the event that the transactions contemplated by the Extraction Oil & Gas merger agreement and the Crestone Peak merger agreement are not consummated.

07:22 EDT TScan Therapeutics appoints Heather Savelle as VP, investor relations - TScan Therapeutics announced the appointment of Heather Savelle as Vice President, Investor Relations. Prior to joining TScan, Ms. Savelle was a Managing Director at Argot Partners, LLC where she provided strategic communications counsel to biotechnology companies across all stages of development and commercialization.

07:19 EDT QOMPLX selected by InQlusiv in partnership to support insurance options in US - QOMPLX announces the expansion and use of its Q:INSURANCE Underwriting Decision Platform into the U.S. market for parametric insurance offerings. This technology supports new U.S. parametric coverage insurance policies, initially through a partnership with InQlusiv. The technology allows insurance industry Managing General Agencies and brokers to automate the underwriting process and rules. Advanced analytics capabilities enhance risk management intelligence for selection and data-driven decision-making. "QOMPLX is InQlusiv LLC's prime technology partner for parametric insurance. Their ability to parse enormous quantities of data allows more accurate pricing of event driven parametric risk coverage. Consequently, InQlusiv, LLC can offer community-based businesses highly cost competitive parametric insurance coverage," said Andrew Terrell, Co-Founder and Managing Partner of InQlusiv. "Our partnership with QOMPLX powers the next chapter in the development, distribution and servicing of innovative insurance solutions, allowing us to serve a wider, more diverse and inclusive world."

07:18 EDT IEC Electronics, Creation announce completion of tender offer - IEC Electronics and Creation Technologies jointly announced the successful completion of the tender offer by CTI Acquisition Corp. for all of the issued and outstanding shares of common stock of IEC for a price of $15.35 per share in cash, without interest and less any applicable withholding taxes. The Offer expired at 5:00 p.m., New York city time, on October 4, 2021. Creation expects to complete the acquisition of IEC today through a merger without a vote of IEC stockholders pursuant to Section 251(h) of the General Corporation Law of the State of Delaware. The depository for the Offer has advised Creation that, as of the expiration of the Offer, a total of 7,731,697 shares had been validly tendered into and not validly withdrawn from the Offer, which tendered shares represent approximately 72.5% of IEC's outstanding shares of common stock and a sufficient number of shares such that the minimum tender condition to the Offer was satisfied. Additionally, the depository has advised that an additional 372,889 shares had been tendered by notice of guaranteed delivery, representing approximately 3.5% of the IEC shares of common stock outstanding. Accordingly, all shares that were validly tendered and not validly withdrawn were accepted for payment, and CTI Acquisition Corp. will promptly pay for all such tendered shares in accordance with the terms of the Offer. As a result of the merger, IEC will become a wholly owned subsidiary of Creation. In the merger, each share of common stock of IEC will be cancelled and converted into the right to receive the same $15.35 per share in cash, without interest and less any applicable withholding taxes, that was paid in the Offer. Following completion of the merger, IEC's common stock will no longer be listed for trading on the Nasdaq Global Market, which is expected to take effect later today.

07:17 EDT Pico launches ultra-low latency venue connectivity - Pico announced it is continuing to advance its comprehensive technology solutions with the introduction of ultra-low latency venue connectivity. The company said, " Pico's ultra-low latency solution supports clients with latency-sensitive trading strategies requiring highly accurate views of the market and faster execution times. Utilizing high-performance Layer 1 switching technology, Pico can now achieve one-way market data latency of 5-87ns and round-trip latency of 140ns for order entry. This new Layer 1 offering is supported by Pico's global engineering expertise and instrumented with its best-in-class Corvil Analytics, assuring operational performance, transparency, and visibility. Corvil's real-time analytics continuously monitors Layer 1 switch transit latency, with immediate alerts generated if nanosecond thresholds are violated, providing maximum operational transparency for latency-sensitive trading. End-of-day reports on details including message rates, microbursts, and gap detection give clients important service assurance visibility."

07:14 EDT Kaleido Biosciences says KB295 reaches primary endpoint in non-IND study - Kaleido Biosciences announced topline data from the non-IND/CTA clinical study evaluating KB295, a novel Microbiome Metabolic Therapy, in mild-to-moderate ulcerative colitis. The primary objective of safety and tolerability was achieved as KB295 was well tolerated and no safety concerns were observed. In the study, subjects receiving KB295 experienced a reduction in three biomarkers, fecal calprotectin, fecal lactoferrin, and FimH that are known to be associated with UC disease activity. These results are complemented by preclinical studies conducted with Kaleido's unique translational ex vivo platform using human donor-derived microbiome communities. Clinical Data Observed at the End of an Eight-Week Intake Period: Achieved primary objective of safety and tolerability with KB295 being well tolerated across subjects with no product-emergent serious adverse events reported; Observed a meaningful reduction in three key biomarkers: FCP, fecal lactoferrin, and FimH, known to be strongly correlated with inflammation and disease activity: Median FCP levels decreased by 69% in subjects with evaluable FCP, and 74% in subjects identified as responders; responders were defined as those subjects with FCP reduction greater than 50%; Fecal lactoferrin decreased by a median of 69% in subjects with currently available samples, including five out of six subjects with a reduction of at least 50%; FimH decreased by a median of 93% in subjects evaluated with currently available samples Further fecal lactoferrin and FimH analysis is expected as additional subject samples become available. Pre-Clinical Data from Ex-Vivo Studies: Ex-vivo data demonstrated community-wide changes and desired modulation of multiple remission-associated taxa; Total short chain fatty acid production increased in ex-vivo studies to levels that are pharmacologically relevant to UC. Anticipated Milestones: Observations from both preclinical and clinical data support the Company's plans to initiate a phase 2 study, under an Investigational New Drug application and Clinical Trial Application, with KB295 for mild-to-moderate UC patients in the first half of 2022; Manufacturing and toxicity work has commenced to support future studies under CTA and IND applications.

07:10 EDT Lantronix expands Connectivity Services with site-to-site VPN security - Lantronix announced the expansion of its Connectivity Services now with site-to-site Virtual Private Network security. Offered across more than 600 networks in 185 countries worldwide, Lantronix Connectivity Services is now available for easy, self-serve ordering through the eStore.

07:08 EDT Unity Biotechnology announces 12-week data from Phase 1 trial of UBX1325 - UNITY Biotechnology announced 12-week data from its ongoing Phase 1 safety study of UBX1325 in patients with advanced disease from diabetic macular edema and wet age-related macular degeneration for whom anti-VEGF therapy was no longer considered beneficial. The data show strong and sustained responses following a single injection of UBX1325 out to 12 weeks and add substantively to the previously reported 8-week dataset, which provided initial evidence of efficacy. The 24-week data from the study is expected before the end of the year. UBX1325, a small molecule inhibitor of Bcl-xL and the first senolytic drug candidate for ophthalmologic diseases targeting a distinctive biologic pathway from anti-VEGF therapies, continues to be well-tolerated with no treatment-related adverse events or dose-limiting toxicities up to 12 weeks. Additionally, UBX1325 showed sustained responses in key clinical measures of disease progression in most patients through 12 weeks, including substantial improvements in best-corrected visual acuity and central subfield thickness. Treatment of patients with a single UBX1325 injection resulted in the following clinical changes at 12 weeks following treatment: Gain in ETDRS Letters from Baseline in Best-Corrected Visual Acuity: Overall: 8 of 12 patients showed a gain in ETDRS letters from baseline in BCVA at 12 weeks In high dose groups: 5 of 6 patients showed a gain in ETDRS letters from baseline in BCVA at 12 weeks. Decrease in Central Subfield Thickness: Overall: 6 of 10 patients had a decrease in CST at 12 weeks, excluding two patients who received anti-VEGF rescue therapy following progression of underlying disease; In high dose groups: 3 of 5 patients showed decrease in CST at 12 weeks, excluding one patient who received anti-VEGF rescue following progression of underlying disease. The Phase 1, open-label, single-ascending dose study includes 12 patients with advanced DME or wet AMD who were no longer expected to benefit from anti-VEGF therapies. Patients enrolled in the study could not have received an anti-VEGF therapy or corticosteroid for three months prior to receiving a single dose of UBX1325. At 12 weeks following treatment with study drug, UBX1325 demonstrated a favorable safety profile supporting further clinical development. There were no dose-limiting toxicities observed, with two nonserious, nondrug-related adverse events reported through 12 weeks. UNITY expects to share 8-week data from an additional cohort of patients with wet AMD, as well as complete 24-week data of the original cohort from the Phase 1 single ascending dose study, before the end of the year.

07:06 EDT Gemini Therapeutics announces corporate restructuring, leadership changes - Gemini Therapeutics announced a corporate restructuring, including several executive officer transitions, to prioritize assets and focus on initiating and executing GEM103's resource-intensive pivotal trial in geographic atrophy, or GA. As part of the company's restructuring, Gemini's research and non-clinical programs will be ceased, including activities associated with gene therapy programs and translational research on Complement Factor H, or CFH, and Complement Factor I, or CFI. The company will accordingly reduce employee headcount by 20% compared to planned 2021 year-end headcount, including the elimination or transition of certain leadership positions. Georges Gemayel, Gemini's chair of the board, will transition to serve as executive chair. Avner Ingerman has been promoted to serve as Gemini's chief development officer, taking on strategic development functions and oversight including regulatory affairs and medical affairs responsibilities. Brian Piekos, CFO, will now additionally serve as chief business officer and assumes additional leadership responsibilities for various functions including manufacturing, business development, and investor relations. The roles of chief scientific officer and chief people officer, held by Walter Strapps and Precillia Redmond, respectively, will be eliminated by the end of the year.

07:03 EDT Dream Finders Homes acquires assets of McGuyer Homebuilders for $471M - Dream Finders Homes announced it has acquired the homebuilding, mortgage banking and title insurance assets of privately held Texas homebuilder McGuyer Homebuilders, Inc. and related affiliates, for $471M in cash at closing, subject to post-closing adjustments. The acquisition will significantly increase DFH's geographic operations in the Austin metro area, and will allow DFH to expand into the attractive Texas markets of Houston, Dallas and San Antonio. Assets acquired include 1,850 home sites, a backlog of 1,845 homes with a value in excess of $1B and 5,500 lots under control. As a result of the acquisition, DFH will own or control over 40,000 lots. DFH acquired a backlog of 1,845 units that are expected to generate revenues in excess of $1 billion over the next 12 to 18 months. The majority of the assets acquired are homes under construction, which are anticipated to be delivered from the period immediately after closing and over the next 270 days. MHI stakeholders retained approximately $100 million of finished lots previously held on balance sheet, effectively restructuring MHI as an asset-light homebuilder. This land bank structure provides DFH the option to take down the retained home sites over a 2-year period post-acquisition, and will remain in place as a revolving facility to finance MHI's future land acquisition activity off-balance sheet. During a second closing in the fourth quarter of 2021, DFH expects to acquire MHI's model home portfolio of 90 units with an estimated retail value of $65 million. DFH plans to market this portfolio to investors in a sale and leaseback arrangement, immediately generating significant cash flows that the Company plans to use to pay down its outstanding debt under the unsecured credit facility. DFH issued Convertible Preferred Stock that is fully redeemable at the Company's option in years 4 and 5, with the goal of zero shareholder dilution at a competitive annual rate of 9%. MHI, doing business as Coventry Homes, builds in the Texas markets of Houston, Dallas, Austin and San Antonio, has been operating since 1988 and has closed over 55,000 homes. MHI primarily serves move-up homebuyers with price points ranging from the mid-$300,000s to over $700,000s, and has over 100 active selling communities. As part of the asset acquisition, MHI's CEO and all of their employees will remain with the combined company and continue to operate the existing and new home communities under the Coventry Homes brand. To consummate the transaction, DFH used cash on hand of $20 million, and issued 150,000 shares of newly-designated Series A Convertible Preferred Stock with an initial liquidation preference of $1,000 per share and a par value $0.01 per share for an aggregate purchase price of $150 million. In addition, DFH increased the aggregate commitments under its senior unsecured revolving credit facility to $818 million, and simultaneously with the closing of the acquisition paid off MHI's vertical lines of credit facilities for approximately $300 million.

06:58 EDT Crypto names edge higher in pre-market as bitcoin tests $50,000 - The price of bitcoin is extending its two-day gains with an overnight rally above the $50,000 - the first time it has traded above that level since September 7th. Stocks levered to bitcoin prices are also edging higher in early pre-market trading, with Bit Digital (BTBT) up 4.7%, Riot Blockchain (RIOT) up 2.6%, Marathon Digital (MARA) up 3.2%, and Coinbase Global (COIN) up 1.5%.

06:43 EDT PepsiCo sees Frito-Lay's core operating profit improving in Q4 - PepsiCo expects Frito-Lay's core operating profit performance to improve in Q4 as certain supply chain pressures ease and revenue management actions are implemented to mitigate the impact of higher commodity, transportation, and other supply chain costs.

06:36 EDT AstraZeneca requests EUA for AZD7442 for COVID-19 prophylaxis from FDA - AstraZeneca announced it has submitted a request to the U.S. Food and Drug Administration for an Emergency Use Authorization, or EUA, for AZD7442, its long-acting antibody combination, for prophylaxis of symptomatic COVID-19. "If granted, AZD7442 would be the first LAAB to receive an EUA for COVID-19 prevention. It is the first LAAB with Phase III data demonstrating a statistically significant reduction in the risk of developing symptomatic COVID-19 compared to placebo," AstraZeneca stated. Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: "Vulnerable populations such as the immunocompromised often aren't able to mount a protective response following vaccination and continue to be at risk of developing COVID-19. With this first global regulatory filing, we are one step closer to providing an additional option to help protect against COVID-19 alongside vaccines. We look forward to sharing AZD7442 data for the treatment of COVID-19 later this year."

06:33 EDT Ventas to transition operations of 90 senior living communities to new managers - Ventas announced that it intends to transition operations of 90 senior living communities owned by Ventas that have been adversely affected by the COVID-19 pandemic to eight experienced operators to best position the Communities to benefit from the expected cyclical recovery of senior living. The Communities are currently operated under management agreements with Eclipse Senior Living, or ESL, which was party to the strategic decision behind the transition. The Communities will be operated by the New Managers under incentivized management contracts. The Communities are located in 20 states, principally in markets with positive forward supply-demand characteristics, which should position the Communities to recapture value and net operating income, or NOI, over time as the COVID-19 pandemic abates and the industry recovers. The Communities were not contributors to the Company's overall NOI or its Senior Housing Operating Portfolio NOI in the second quarter 2021. Ventas expects to incur certain one-time transition costs and expenses in connection with the transitions. ESL is expected to cease operation of its management business in 2022 following transition of the Communities. Most of the transitions are expected to be completed by the end of 2021, subject to final documentation, regulatory approvals and other customary conditions.

06:08 EDT PepsiCo sees FY21 core effective tax rate of 21% - Sees total cash returns to shareholders of approximately $5.9 billion, comprised of dividends of approximately $5.8 billion and share repurchases of $106 million. PepsiCo said: "We completed our share repurchase activity and do not expect to repurchase any additional shares for the balance of 2021."

06:02 EDT Patterson-UTI reports an average of 83 drilling rigs operating in September - Patterson-UTI reported that for the month of September, the company had an average of 83 drilling rigs operating. For the three months ended September 30, the company had an average of 80 drilling rigs operating.

05:26 EDT Genentech to present new Ocrevus, Enspryng data at ECTRIMS - Genentech, a member of Roche, announced that new Ocrevus and Enspryng data will be presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis, or ECTRIMS, from October 13-15. These data include 38 abstracts highlighting new longer-term efficacy and safety for both Ocrevus and Enspryng, as well as our ongoing efforts to evaluate the impact of the COVID-19 pandemic for people living with MS. Additional data will show how a deeper scientific understanding of MS and NMOSD in diverse patient populations could help ensure access to treatment. Genentech will present 27 MS studies, including long-term data that show earlier treatment with Ocrevus continues to impact disability progression up to eight years in people with primary progressive multiple sclerosis, or PPMS, and up to 7.5 years in people with relapsing multiple sclerosis, or RMS, in the Phase III open label extension, or OLE, studies. Additionally, updated long-term safety analysis of all clinical trials in patients with RMS and PPMS will reinforce the consistently favorable benefit-risk profile of Ocrevus. Genentech remains committed to addressing health disparities and we believe inclusive research can improve outcomes and derive insights that may address treatment barriers. A subgroup analysis of three studies in Black, African-American, Hispanic and Latino populations treated with a two-hour Ocrevus infusion will be presented. New longer-term results from the SAkuraStar and SAkuraSky OLE studies for Enspryng will show efficacy observed in the pivotal trials is sustained with high proportions of patients remaining free from relapse over four years of treatment. Similarly, safety data from the SAkuraStar and SAkuraSky OLE studies will show the favorable safety profile of Enspryng is sustained with longer-term treatment. Enspryng has been approved in 58 countries globally, including in the U.S. as the first and only subcutaneous treatment for adults with anti-aquaporin-4 antibody seropositive NMOSD. Enspryng has also been approved for both adults and adolescents in the European Union, Japan, Canada and Switzerland. Genentech is dedicated to increasing scientific understanding of NMOSD and improving care for all people living with the condition. The study design will be presented for SAkuraBONSAI, a prospective, open-label study of Enspryng to generate data to further the understanding of the disease activity and mechanism of action of Enspryng in patients living with AQP4-IgG seropositive NMOSD who are treatment naive or where prior rituximab treatment has failed. Other presentations will examine the development of new tools and techniques to identify patients with NMOSD and assess disability better.

05:12 EDT Orphazyme announces regulatory update for arimoclomol - Orphazyme announced regulatory updates for its investigational drug candidate, arimoclomol, for which it is seeking marketing authorization in both Europe and the United States for the treatment of Niemann-Pick disease Type C, or NPC. The company also announces that it now expects to end 2021 with a cash position of no less than DKK 80M compared to prior guidance of approximately DKK 50M.The review process under the centralized procedure in Europe is underway. Following dialogue with the Rapporteurs and the anticipated timeline to respond to the Day 180 List of Outstanding Issues, the company now anticipates a CHMP opinion in Q1 2022 compared to previous Q4. In the United States, Orphazyme requested and has been granted a Post-Action Type A meeting with the FDA, which has been scheduled for mid-October. At this meeting, the company plans to engage in a collaborative dialogue with the FDA to better understand its decision in the Complete Response Letter issued in June, as well as to discuss proposals to address key topics raised in the letter. The company expects to communicate an update to the market once it has received and assessed formal minutes from the FDA Type A meeting. The improved cash guidance relates to the ongoing restructuring plan, which has enabled the company to deliver more than anticipated savings in terms of headcount and other costs. The company continues to assess different possibilities for obtaining additional funding to sustain operations in the longer-term.

05:05 EDT Navigator Holdings enters seafarer training collaboration with Northern Marine - Navigator Holdings announced a seafarer training collaboration with Northern Marine which will prepare RO-PAX ferry officers to operate gas-fueled vessels of the future. To obtain their certification to operate LNG-fueled ferry vessels, the Northern Marine officers are experiencing working life onboard Navigator Gas's 37,500 cbm ethylene capable gas carrier Navigator Aurora. The Ethylene/LPG Carrier vessel provides an environment where the officers can gain their 30-day sea time working with a low-flashpoint fuel by shadowing officers onboard.