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$PVSP The below Washington State (WA) sales by category chart provides information on how monthly sales of approximately $100 million in retail sales breaks down by product category. It might also be informative to understand that June ’22 sales over June ’19 sales (pre pandemic) show an almost 17% increase. While WA sales are slightly above other mature cannabis states (NV, CO, OR), similar increases can be seen in those markets. An exuberant pandemic triggered belief in continued rapid growth has led to over development of production infrastructure and resulted in material oversupply of bulk cannabis flower. The market is in the process of correcting and the Company estimates Q3 2023 being the end of the corrective period, resulting in strengthening prices.
https://www.benzinga.com/pressreleases/22/09/g28756512/24-month-roadmap-to-50-million-in-sales
GTXOD - MetAlert is a company that is constantly innovating and expanding its product offerings. With the recent announcement of the rebranding and future launch of some of these products, they are positioning themselves as a one-stop shop for all your remote patient monitoring technology needs. Whether you are looking for a way to keep an eye on your elderly parent or need a device to help you manage your diabetes, MetAlert has or is working on a solution. So be sure to check out their website today www.metalert.com and see how they can help you live your life more safely and securely.
SODE: SS is almost the same (OS 197M, Unrestricted 30M, 10/03/2022) as it was 1.5 yrs ago when SODE ran from the same bottom pps to $0.9! (30x resp 3000%)
$AITX News: AITX's Subsidiary Robotic Assistance Devices Group (RAD-G) Launches Efforts to Penetrate New Markets
Initiative Will Place RAD's Industry-ProvenAI-Based Security Hardware and Software in OEM Devices
Detroit, Michigan, Oct. 03, 2022 (GLOBE NEWSWIRE) -- Artificial Intelligence Technology Solutions, Inc., (OTCPK:AITX), today announced that its wholly owned subsidiary, Robotic Assistance Devices, Group (RAD-G) has launched efforts to provide OEM system-level components to specific industries and clients outside of the Company's existing security services industry footprint.
To support and lead these efforts, the Company has named Ravi Gade as RAD-G's OEM Program Director. "I am pleased to welcome Ravi to the RAD team," said Steve Reinharz, CEO of AITX. "Ravi is an accomplished business builder that has been part of the RAD and AITX orbit for some time. I believe that Ravi leading the RAD-G efforts of placing RAD's hardware and software in new markets has significant potential."
"I am excited to be joining forces with the team at RAD and AITX," said Ravi Gade. "I look forward to applying my experiences in business development and AI to secure RAD-G's inevitable position in providing exceptional OEM solutions."
RAD-G's initial product offering is RADPack Millie, a FPGA (field programmable gate array). FPGAs, like RADPack Millie, can deliver superior performance in deep learning applications where low latency is critical. FPGAs can be fine-tuned to balance power efficiency with performance requirements. Devices currently offered by RAD-G's sister company and AITX wholly owned subsidiary, Robotic Assistance Devices (RAD) are powered by components closely related to RADPack Millie. These integrated solutions from RAD have received wide acclaim and have been honored with multiple awards within the security services and #proptech industries. RAD devices have the ability to autonomously detect and respond to instances of trespassing, loitering, the presence of firearms and more utilizing its advanced human, vehicle and other situational detections.
RAD-G will initially promote RADPack Millie in the EV (electric vehicle) charging station industry. According to recent reports, the number of public charging stations in the US has tripled since 2015 when there were fewer than 32,000 and is projected to reach between 800,000 and 1.7 million by the end of the decade. At the beginning of 2022, the Biden administration launched a $5 billion five-year plan to improve electric vehicle charging network infrastructure.
"The team at RAD and RAD-G has been in development of RADPack Millie and other FPGA, system-level, plug and play solutions for the past 16 months. Our plan is to offer EV charging station manufacturers a low-cost, add-on component to their existing charging stations," Reinharz added. "RADPack Millie when integrated into a charging station will support up to four cameras, lights, speakers, and more. This will greatly expand the value of any charging station, providing much need security and safety features to an often vulnerable situation."
"RAD has accomplished great things in the security services industry," continued Gade. "With RAD-G we're now packaging all the performance of RAD and making it available to OEMs in the EV charging industry and beyond."
Pricing for RAD-G's RADPack Millie has not been announced. Quantity-based pricing is offered along with a NRE cost (non-recurring engineering) cost. For more information, please visit radgroup.ai.
RAD-G's parent company AITX has filed for uplisting to the OTCQB. Future announcements will be made regarding the status of the OTCQB application.
Robotic Assistance Devices Group (RAD-G) is a high-tech start-up that produces and delivers component-level artificial intelligence-based solutions that empower organizations to offer enhanced solutions based on proven technology, with a quick time-to-market. RAD-G has developed its advanced technology from the ground up including circuit board design, and base code development.
CAUTIONARY DISCLOSURE ABOUT FORWARD-LOOKING STATEMENTS
This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this news release other than statements of historical fact are "forward-looking statements" that are based on current expectations and assumptions. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the statements, including, but not limited to, the following: the ability of Artificial Intelligence Technology Solutions to provide for its obligations, to provide working capital needs from operating revenues, to obtain additional financing needed for any future acquisitions, to meet competitive challenges and technological changes, to meet business and financial goals including projections and forecasts, and other risks. No information contained in this news release should be construed as any indication whatsoever of the Company's future stock price, revenues, or results of operations. Additionally, industry data provided herein is of no predictive value regarding the future sale of the Company's products. Artificial Intelligence Technology Solutions undertakes no duty to update any forward-looking statement(s) and/or to confirm the statement(s) to actual results or changes in Artificial Intelligence Technology Solutions expectations.
About Artificial Intelligence Technology Solutions (AITX)
AITX is an innovator in the delivery of artificial intelligence-based solutions that empower organizations to gain new insight, solve complex challenges and fuel new business ideas. Through its next-generation robotic product offerings, AITX's RAD, RAD-M and RAD-G companies help organizations streamline operations, increase ROI, and strengthen business. AITX technology improves the simplicity and economics of patrolling and guard services and allows experienced personnel to focus on more strategic tasks. Customers augment the capabilities of existing staffs and gain higher levels of situational awareness, all at drastically reduced cost. AITX solutions are well suited for use in multiple industries such as enterprises, government, transportation, critical infrastructure, education, and healthcare. To learn more, visit http://www.aitx.ai, http://www.stevereinharz.com, http://www.radsecurity.com,radgroup.ai, and http://www.radlightmyway.com, or follow Steve Reinharz on Twitter @SteveReinharz.
###
Steve Reinharz
949-636-7060
@SteveReinharz
$AGYP undervalued oil play at .115. Chart oversold (RSI 38) >>
Allied Energy Corp.
47M float #Oil #Gas
https://alliedengycorp.com/
https://stockcharts.com/h-sc/ui?s=AGYP
$AMYZF $AMY RecycLiCo Battery Materials announces official name change from American Manganese
https://americanmanganeseinc.com/american-manganese-changes-name-to-recyclico-battery-materials-inc/
$APRN Top Short Squeeze Stock - Targets $9/$12/15
~ "Blue Apron Holdings, Inc. was the target of unusually large options trading on Tuesday.
~ 72% Short Interest
~ Private placement closing by Sept. 30th to receive $56M cash and complete the $25M buyback
~ $124.2M rev. in Q2
~ Buyback can move float to 5M
~ $130M cash on hand
~ Strong fundamentals
~ Chart has a lot of room to run
~ Many Catalysts on the Way
~ Joe Sanberg bought 11.6M shares at $12 & $5.65 on September 7th and now owns 27M shares
~Huge Inside/Institutional Ownership
$IVDN - For Hurricane Ian Rebuilding Effort...
Patented House Wrap Insulation with Thermal Energy Saving Far Beyond Competition Gaining Recognition as Company Wins Court Case & 260K Cash Settlement: Innovative Designs, Inc.
Click here:
https://www.digitaljournal.com/pr/patented-house-wrap-insulation-with-thermal-energy-saving-far-beyond-competition-gaining-recognition-as-company-wins-court-case-260k-cash-settlement-innovative-designs-inc-otcqb-ivdn#ixzz7eEHyv3uY
Company website:
http://www.insultexhousewrap.com
$CEOS Company Tweet.
We are pleased to announce the milestone of having our SHELL STATUS REMOVED by OTC Markets. We are hard at work continuing to develop revenue boosting ventures and innovative products. Long-term sustainable growth and building shareholder value is our goal.
We are pleased to announce the milestone of having our SHELL STATUS REMOVED by OTC Markets. We are hard at work continuing to develop revenue boosting ventures and innovative products. Long-term sustainable growth and building shareholder value is our goal. $CEOS #PsyKey
— PsyKey Inc. ($CEOS) (@PsyKeyworld) September 29, 2022
$AGYP undervalued oil play at .119. Pre-Market chart >>
#Oil #Gas 47M float
https://alliedengycorp.com/
$HWAL..Shaping up!>>>>https://www.barchart.com/stocks/quotes/HWAL/news
$PVSP Located in beautiful Port Townsend, on the northern end of the Olympic Peninsula, this gorgeous light deprivation greenhouse garden is producing beautiful flower and is home to some of the more exotic genetics in the Artizen brand. At 39,000 square feet it is the second largest of all of the gardens growing Artizen branded flower.
$AITX News: AITX's Subsidiary Robotic Assistance Devices Receives Multiple Orders Through New and Existing Dealers
Orders for 15 Devices Secured Since Participation at Security Industry Trade Show
Detroit, Michigan, Sept. 27, 2022 (GLOBE NEWSWIRE) -- Artificial Intelligence Technology Solutions, Inc., (OTCPK:AITX), today announced that its wholly owned subsidiary, Robotic Assistance Devices, Inc. (RAD) has received six orders, totaling fifteen units, from two recently signed and four existing authorized dealers. The product mix of the fifteen security devices ordered since the last public announcement are eleven RIOs, two ROSAs and two AVAs.
"Returning home from a great GSX trade show saw the RAD dealer channel respond with healthy new business," said Mark Folmer, President at RAD. "Four of our very active dealers and two dealers that just came on board have validated that what we showed at GSX is precisely what their customers are demanding."
RAD exhibited at GSX 2022 in Atlanta from September 12 through 14. On display at the security industry trade show were RIO, several ROSAs and AVA.
"RAD dealers have their fingers on the pulse of what's going on in the security services industry," said Steve Reinharz, CEO of AITX and RAD. "They experience the ongoing security staffing issues every day, and hear their clients demand more tech and automation to help reduce costs and keep their properties safe and secure. It's inevitable that these issues lead them to RAD. We're in the business of making their clients' security problems go away while we save them money," Reinharz concluded.
RAD expects to make additional announcements of other recently signed authorized dealers and further sales updates in the immediate future.
RIO has been designed with portability and round-the-clock performance at its core. RIO is completely self-contained as well as self-sufficient. All components necessary to provide day and nighttime security and surveillance are included with RIO. All networking hardware and software is provided, including RAD's 'optimized cellular' connectivity. At its base stands a ruggedized portable trailer positioning the unit's two solar panels and housing the device's high-performance batteries and control systems. RIO's retractable mast extends nearly 20' where a single ROSA is mounted providing an ideally positioned 180° field of view through its two high resolution PTZ cameras. To achieve a 360° field of view, a ROSA-Expander unit is also available.
ROSA is a multiple award-winning, compact, self-contained, portable, security and communication solution that can be deployed in about 15 minutes. Like other RAD solutions, a stand-alone ROSA only requires power, which is provided when configured along with RIO, as it includes all necessary communications hardware. ROSA's AI-driven security analytics include human, firearm, vehicle detection, license plate recognition, responsive digital signage and audio messaging, and complete integration with RAD's software suite notification and autonomous response library. Two-way communication is optimized for cellular, including live video from ROSA's dual high-resolution, full-color, always-on cameras. RAD has published two Case Studies detailing how ROSA has helped eliminate instances of theft, trespassing and loitering at car rental locations and construction sites across the country.
AVA (Autonomous Verified Access) is a compact and stanchion mountable unit that provides an edge-to-edge 180° field of vision with advanced access control over gates and other controlled points of entry. AVA takes full advantage of the RAD Software Suite providing an ideal solution for logistics and distribution centers, storage yards, parking structures and lots, corporate campuses; anywhere that increased visibility is needed at a fraction of the cost. At ISC West in late March, AVA was named a winner of the 2022 SIA New Products and Solutions Awards in the category of Access Control Software, Hardware, Devices and Peripherals.
RAD's parent company AITX has filed for uplisting to the OTCQB. Future announcements will be made regarding the status of the OTCQB application.
Robotic Assistance Devices (RAD) is a high-tech start-up that delivers robotics and artificial intelligence-based solutions that empower organizations to gain new insight, solve complex security challenges, and fuel new business ideas at reduced costs. RAD developed its advanced security robot technology from the ground up including circuit board design, and base code development. This allows RAD to have complete control over all design elements, performance, quality, and the user's experience of all security robots whether SCOT(TM), ROSA(TM), Wally(TM), Wally HSO(TM), AVA(TM), ROAMEO(TM), CASSIE(TM), RIO(TM), or RAD Light My Way(TM). Read about how RAD is reinventing the security services industry by downloading the Autonomous Remote Services Industry Manifesto, and request a copy of the recently published 'Navigating the New Economy: Jobs & Automation, Challenges & Opportunities'.
CAUTIONARY DISCLOSURE ABOUT FORWARD-LOOKING STATEMENTS
This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this news release other than statements of historical fact are "forward-looking statements" that are based on current expectations and assumptions. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the statements, including, but not limited to, the following: the ability of Artificial Intelligence Technology Solutions to provide for its obligations, to provide working capital needs from operating revenues, to obtain additional financing needed for any future acquisitions, to meet competitive challenges and technological changes, to meet business and financial goals including projections and forecasts, and other risks. No information contained in this news release should be construed as any indication whatsoever of the Company's future stock price, revenues, or results of operations. Additionally, industry data provided herein is of no predictive value regarding the future sale of the Company's products. Artificial Intelligence Technology Solutions undertakes no duty to update any forward-looking statement(s) and/or to confirm the statement(s) to actual results or changes in Artificial Intelligence Technology Solutions expectations.
About Artificial Intelligence Technology Solutions (AITX)
AITX is an innovator in the delivery of artificial intelligence-based solutions that empower organizations to gain new insight, solve complex challenges and fuel new business ideas. Through its next-generation robotic product offerings, AITX's RAD, RAD-M and RAD-G companies help organizations streamline operations, increase ROI, and strengthen business. AITX technology improves the simplicity and economics of patrolling and guard services and allows experienced personnel to focus on more strategic tasks. Customers augment the capabilities of existing staffs and gain higher levels of situational awareness, all at drastically reduced cost. AITX solutions are well suited for use in multiple industries such as enterprises, government, transportation, critical infrastructure, education, and healthcare. To learn more, visit www.aitx.ai, stevereinharz.com, www.radsecurity.com and www.radlightmyway.com, or follow Steve Reinharz on Twitter @SteveReinharz.
###
Steve Reinharz
949-636-7060
@SteveReinharz
Attachment
Artificial Intelligence Technology Solutions, Inc.
$MRNJ on strong alert with two big updates since Friday >>
#AI #ArtificialIntelligence #Metaverse
$MRNJ Metatron is in negotiations for its second acquisition this month and has sent a Letter of Intent to purchase another AI based software product.
$MRNJ Metatron is in negotiations for its second acquisition this month and has sent a Letter of Intent to purchase another AI based software product.
— Metatron Apps Inc-OTC $MRNJ (@MetatronInc) September 26, 2022
$AMYZF RecycLiCo Battery Materials Provides Corporate Update
https://www.accesswire.com/717517/recyclico-battery-materials-provides-corporate-update
$AITX Tweet today - Let's get this week going!!! We've 4 software dev teams, the biggest of which drives RADSoC (others are autonomy, perception and radpack). I love all the teams. . . just so fun creating class-leading industry-changing software. Let's have a great week!
Twiter Link:
$AITX Let's get this week going!!! We've 4 software dev teams, the biggest of which drives RADSoC (others are autonomy, perception and radpack). I love all the teams. . . just so fun creating class-leading industry-changing software. Let's have a great week! pic.twitter.com/GVqRlUBmEP
— Steve Reinharz (@SteveReinharz) September 26, 2022
30% Media Yield Gains
AI Growth Hub Inc. Specializes in Responsible AI Systems to Significantly Improve Marketing Campaign Performance
AI Growth Hub Inc an Xalles Subsidiary
https://xalles.com/ $XALL
$MRNJ on strong watch this week at .0005 with multiple updates hitting last week. #AI #ArtificialIntelligence #Metaverse
Metatron Inc. Announces Additional 30-Day Moratorium On Dilution Throughout The Entire Month of October
https://www.globenewswire.com/news-release/2022/09/23/2521874/0/en/Metatron-Inc-Announces-Additional-30-Day-Moratorium-On-Dilution-Throughout-The-Entire-Month-of-October.html
Metatron Inc. Signs Contract to Complete Its First Artificial Intelligence Technology Acquisition
https://www.globenewswire.com/news-release/2022/09/21/2520304/0/en/Metatron-Inc-Signs-Contract-to-Complete-Its-First-Artificial-Intelligence-Technology-Acquisition.html
$MRNJ tweeted Friday Co. negotiating AI acquisition. Update: negotiations complete, definitive closing docs being put together for quick closing. Another AI project being reviewed in addition. #ArtificialIntelligence
— Metatron Apps Inc-OTC $MRNJ (@MetatronInc) September 19, 2022
$PVSP Twitter status update: https://twitter.com/PervasipC
$TORVF Fills Essential-Role of Flake-Graphite in EV-Production
How Volt Carbon Tech, Inc / $TORVF fills this Role.
https://www.innovationnewsnetwork.com/essential-role-flake-graphite-vehicle-electrification/24935/
$RQHTF Reliq Health Technologies Insider buying Yesterday.
CEO- Lisa Crossley picked up over 101k shares yesterday for her second large stock purchase at market in the last 2 months. Two financial reports expected in the next 10 weeks so now it is the time to do some serious dd on this one.
$AGYP just announced that they have entered into a strategic joint venture alliance with River Energy Group, LLC, a private company formed to trade and invest in the oil and gas sectors.
The owners of River Energy Group, LLC have very impressive bios with over 90 years of experience in the commodity, derivatives, and financial services industry.
Ownership of the River Energy Group is comprised by:
Director Carl J. Boraiko
Maher Nasri, Director
Joseph R. Wilkins (Investor)
Carl Boraiko brings over 45 years of experience and expertise in the Derivatives and Financial Services Industry with heavy emphasis on physical commodity trading and hedging in multiple sectors. In addition, Mr. Boraiko has been lead consultant and strategist in multiple global projects such as Oil, Gas, and Agriculture concerns in China, Middle East, and Northern Africa. Among other endeavors. He currently serves as Managing Director of Global Trading for Raven Trading Group, LLC, a wholly owned subsidiary of Raven Resource Group, LLC.
Maher Nasri has over 20 years of expertise in finance, accounting operations management, and fund management. He adds an in-depth insight into the core operations covered under the Finance Management Domain within the organization. Mr. Nasri was previously the Finance Manager for the Royal Group of Dubai, UAE, with full responsibility for the entire Finance Functions of the AL Shurfa Real Estate Investments, LLC portfolio of the Royal Group. He played a key role in providing funding, budgetary controls and effective decision making.
Mr. Nasri's credentials are as follows:
BSBA in Accounting
CMA (Certified Management Accountant)
CFM (Certified Finance Manager)
CFC (Certified Financial Consultant)
CFMS (Certified Financial modeling specialist)
Certificate in Financial Control.
Certificate in Business Valuation - CBV.
Certified Project Financier (Project Finance).
Implementation and Customizing HIS & ERP Financial Software. Data analysis with MS Excel BI.
Manages monthly closing as well as maintenance of all Accounting Processes.
Languages: English, Arabic, Russian
$HWAL..Something BIG is brewing!>>>>>Hollywall Entertainment Inc. (HWAL) on Path to Redefining Entertainment Space, Stamping Leading Position in Other Sectors
https://www.streetinsider.com/Investor+Brand+Network/InvestorNewsBreaks+%E2%80%93+Hollywall+Entertainment+Inc.+%28HWAL%29+on+Path+to+Redefining+Entertainment+Space%2C+Stamping+Leading+Position+in+Other+Sectors/19723458.html
Hollywall Entertainment (OTC: HWAL) has become one of the most promising enterprises in the telecommunication, infrastructure, media, technology, entertainment, and broadcasting space. “With a background of years of developing, producing and acquiring some of the world’s most prized entertainment properties and brands, this company is well on its way to redefining the entertainment space and stamping its position as an industry leader in other sectors as well,” reads a recent article. Hollywall has several subsidiaries covering various sectors. “Its subsidiary, Hollywall Development Company (‘HWDC’), for instance, focuses on building, restoring, and creating ‘smart’ cities and communities, leveraging on broadband and 5G networks, tele-education, energy, and other such aspects. On the other hand, HW Vision offers state-of-the-art services targeting the proliferating digital marketplace. These services include web conferencing, video broadcasting, managed internet services, and nationwide unlimited talk, text and data cellphone plans, among others… Going forward, Hollywall looks to launch a new global NFT marketplace for its music, film and software game assets as a way to diversify its revenue and capitalize on the growing NFT space. Hollywall Music, a wholly-owned subsidiary of the company, owns legacy music and video collector assets that have been protected for over 20 years.”
To view the full article, visit https://ibn.fm/SXuWi
About Hollywall Entertainment Inc.
Hollywall Entertainment is a telecommunications, technology, media, entertainment and broadcasting company that operates through its various subsidiaries including: Hollywall Development Company (“HWDC”), HW Vision and HW Latlong, and multiple divisions to include HW School of Communications, Hollywall Music, Hollywall TV, HW Productions, HW Networks, HWRadio, HWGOV and The Hollywall Foundation. HWAL continues to maximize rights to its music, film, television, home videos and software game libraries. Hollywall owns exclusive and nonexclusive rights to market, manufacture and distribute music master recordings performed by legends such as Ray Charles, Ella Fitzgerald, The Jackson 5, Frank Sinatra, Dolly Parton, Elvis Presley, Tony Bennett, The Bee Gees, Chicago, The Platters, George Gershwin, Marvin Gaye, James Brown, The Who, Janis Joplin, Rolling Stones, Nat King Cole, John Lee Hooker, Willie Nelson, Rod Stewart, Hall and Oates, James Taylor, Etta James, Aretha Franklin, and other multiple-platinum-selling acts. Learn more at www.Hollywall.com.
$PVSP After initial trials (3 - 4 months), once we believe we have the right genetics for certain strains, we clone for commercial rollout (~14 days), then let those clones grow into teens (14-18 days), then flip them into our flower rooms to grow into adult females (8-9 weeks)...
$INKW and Holiday Inn Express #BeWater
Let's Welcome, The Holiday Inn Express to the
— GetBeWater... (@getbewater) September 21, 2022
"Be Water" family, Cassie and Staff, will take good care of you, also stop in the 24/7 Pantry and grab a cold one. pic.twitter.com/bwFw51DPkn
$MRNJ ~ Corporate Tweet out! Big news hit yesterday.
#AI #ArtificialIntelligence #Metaverse
Currently working to negotiate some additional great terms for $MRNJ that should prove very exciting and beneficial to shareholders. Additional update when everything is completed. #BuildingValue
— Metatron Apps Inc-OTC $MRNJ (@MetatronInc) September 22, 2022
$MRNJ Acquisition News: Metatron Inc. Signs Contract to Complete Its First Artificial Intelligence Technology Acquisition>>
$PVSP 24 Months plan detail
Rename Pervasip Corp to Artizen Corporation by year end 2022 to better reflect the new focus of the company
Change the OTC ticker symbol
Re-brand all Pervasip/Artizen assets
Continue to rationalize the business through Q1 2023 with a focus on operating margins, shedding underperforming assets, consolidating operations and focus in-house talent on higher margin operations and product lines
Acquire concentrates assets by end of 2022, launching into the highly lucrative concentrates business
Expand flower and concentrates offerings within our brands as well as adding new brands for certain product offerings and price points through Q1 2023
Complete the audit and begin the OTC QB application process during Q2 2023
Launch Artizen Wellness Q2 2023
Enter the edibles market in Q2 2023 via acquisition and partnerships
Artizen becomes an MSO with cultivation and retail assets in 1 – 2 additional states during 2nd half of 2024, beginning its state expansion in Q1 2023, initially through brand licensing opportunities and strategic partnerships, and eventually via acquisitions and mergers during Q3 and Q4 2024
Close first brand licensing agreement by end of Q4 2022
Close one brand licensing deal every quarter thereafter
Financial Outlook Q3 2022 through Q4 2023
Reach $2.0 million in monthly revenue by end of Q1 2023
Reach $2.5 million or $30 million in annualized revenue by end of Q4 2023 with 30% in adjusted EBIDTA
Reach $3.0 million or $36 million in annualized revenues by end of Q2 2024 with 35% in adjusted EBIDTA
Reach $50 million in annualized revenue with 35% in adjusted EBIDTA
Y'all should look at $LUDG today! the float is so small that even a couple of small buys and everybody goes up 50% or better on their money Ludwig Inc also released a significant update on the deal with a big corporation yesterday that may hit the PPS.
https://finance.yahoo.com/news/ludwig-enterprises-emerson-urology-associates-113000319.html
$AITX News: AITX's Subsidiary Robotic Assistance Devices Concludes GSX 2022 With Pre-Orders for 30 RIO Portable Solar Powered Security Towers
September 15, 2022 (Globe Newswire)
EQNX::TICKER_START (Other OTC:AITX),(OTC US:AITX), EQNX::TICKER_END Artificial Intelligence Technology Solutions, Inc., (OTCPK:AITX), today announced that its wholly owned subsidiary, Robotic Assistance Devices, Inc. (RAD) has received pre-order commitments for thirty of the Company's recently announced RIO, portable, solar-powered security solution.
RIO (ROSA Independent Observatory) continues the productization of RAD's best-selling, multiple award-winning security robot known as ROSA. RIO consists of a single ROSA 3.1 unit mounted atop a solar-powered portable trailer, with the option of adding a second ROSA unit.
"Leading up to RIO's formal announcement earlier this week at GSX, we launched a pre-order program exclusively for our authorized dealers and select clients," said Mark Folmer, President at RAD. "The response to RIO prior to GSX was impressive, but once our dealers and their clients saw RIO up close at the show it became quite clear that interest in RIO would exceed our expectations. Clients were pleasantly surprised to learn that RIO included such advanced functionality, and priced well below what they would usually pay."
RAD exhibited at GSX 2022 in Atlanta which concluded Wednesday. On display at the security industry trade show were RIO, several ROSAs and AVA.
"RIO has quickly become RAD's most successful product announcement to date," said Steve Reinharz, CEO of AITX and RAD. "Everything adds up with RIO, it's a lower cost alternative to inferior legacy solutions. I expect RIO to help post some impressive recurring revenue numbers for the Company. We have a winner in RIO," Reinharz concluded.
"The response was so strong at GSX that we've decided to extend the RIO pre-order program through the month of September," Folmer added. "This extension will give many of the new dealers and end-users we met this week time to take advantage of the extra incentives in the RIO pre-order program."
RIO has been designed with portability and round-the-clock performance in mind. RIO is completely self-contained as well as self-sufficient. All components necessary to provide day and nighttime security and surveillance are included with RIO. All networking hardware and software is provided, including RAD's 'optimized cellular' connectivity. At its base stands a ruggedized portable trailer positioning the unit's two solar panels and housing the device's high-performance batteries and control systems. RIO's retractable mast extends nearly 20' where a single ROSA is mounted providing an ideally positioned 180° field of view through its two high resolution PTZ cameras. To achieve a 360° field of view, a ROSA-Expander unit is also available.
RAD expects to make additional announcements of recently signed authorized dealers and additional sales updates in the immediate future.
RAD's parent company AITX has filed for uplisting to the OTCQB. Future announcements will be made regarding the status of the OTCQB application.
ROSA is a multiple award-winning, compact, self-contained, portable, security and communication solution that can be deployed in about 15 minutes. Like other RAD solutions, a stand-alone ROSA only requires power, which is provided when configured along with RIO, as it includes all necessary communications hardware. ROSA's AI-driven security analytics include human, firearm, vehicle detection, license plate recognition, responsive digital signage and audio messaging, and complete integration with RAD's software suite notification and autonomous response library. Two-way communication is optimized for cellular, including live video from ROSA's dual high-resolution, full-color, always-on cameras. RAD has published two Case Studies detailing how ROSA has helped eliminate instances of theft, trespassing and loitering at car rental locations and construction sites across the country.
Robotic Assistance Devices (RAD) is a high-tech start-up that delivers robotics and artificial intelligence-based solutions that empower organizations to gain new insight, solve complex security challenges, and fuel new business ideas at reduced costs. RAD developed its advanced security robot technology from the ground up including circuit board design, and base code development. This allows RAD to have complete control over all design elements, performance, quality, and the user's experience of all security robots whether SCOT, ROSA, Wally, Wally HSO, AVA, ROAMEO, CASSIE, RIO, or RAD Light My Way. Read about how RAD is reinventing the security services industry by downloading the Autonomous Remote Services Industry Manifesto, and request a copy of the recently published 'Navigating the New Economy: Jobs & Automation, Challenges & Opportunities'.
CAUTIONARY DISCLOSURE ABOUT FORWARD-LOOKING STATEMENTS
This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this news release other than statements of historical fact are "forward-looking statements" that are based on current expectations and assumptions. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the statements, including, but not limited to, the following: the ability of Artificial Intelligence Technology Solutions to provide for its obligations, to provide working capital needs from operating revenues, to obtain additional financing needed for any future acquisitions, to meet competitive challenges and technological changes, to meet business and financial goals including projections and forecasts, and other risks. No information contained in this news release should be construed as any indication whatsoever of the Company's future stock price, revenues, or results of operations. Additionally, industry data provided herein is of no predictive value regarding the future sale of the Company's products. Artificial Intelligence Technology Solutions undertakes no duty to update any forward-looking statement(s) and/or to confirm the statement(s) to actual results or changes in Artificial Intelligence Technology Solutions expectations.
About Artificial Intelligence Technology Solutions (AITX)
AITX is an innovator in the delivery of artificial intelligence-based solutions that empower organizations to gain new insight, solve complex challenges and fuel new business ideas. Through its next-generation robotic product offerings, AITX's RAD, RAD-M and RAD-G companies help organizations streamline operations, increase ROI, and strengthen business. AITX technology improves the simplicity and economics of patrolling and guard services and allows experienced personnel to focus on more strategic tasks. Customers augment the capabilities of existing staffs and gain higher levels of situational awareness, all at drastically reduced cost. AITX solutions are well suited for use in multiple industries such as enterprises, government, transportation, critical infrastructure, education, and healthcare. To learn more, visit http://www.aitx.ai, http://www.stevereinharz.com, http://www.radsecurity.com and http://www.radlightmyway.com, or follow Steve Reinharz on Twitter @SteveReinharz.
###
Steve Reinharz
949-636-7060
@SteveReinharz
Attachment
-- Artificial Intelligence Technology Solutions, Inc.
$MRNJ ~ Metatron Inc. Signs Contract to Complete Its First Artificial Intelligence Technology Acquisition
https://www.globenewswire.com/news-release/2022/09/21/2520304/0/en/Metatron-Inc-Signs-Contract-to-Complete-Its-First-Artificial-Intelligence-Technology-Acquisition.html
#AI #ArtificialIntelligence #Metaverse
$SWISF Sekur Private Data Launches SekurMessenger for Enterprises - Enters Financial and Legal, Medical Industries and Government Organizations with Archiving Feature and Mass Onboarding
https://www.accesswire.com/716841/Sekur-Private-Data-Launches-SekurMessenger-for-Enterprises--Enters-Financial-and-Legal-Medical-Industries-and-Government-Organizations-with-Archiving-Feature-and-Mass-Onboarding
$HWAL..Valuation should be a bit higher IMO>>>>https://hollywall.com/infrastructure/
Infrastructure
Water and Waste Water
Hollywall’s team includes an Environmental Engineering division that has extraordinary expertise in water and wastewater management. We are involved in numerous aspects of environmental design and construction oversight, including but not limited to: pump station and force main design; water treatment and distribution; wastewater collection and treatment; and environmental construction management and inspection.
Transportation
Hollywall’s team includes highly experienced staff of engineers and specialists have successfully managed and implemented transportation project solutions for a wide range of clients. We provide the expertise to formulate and evaluate an array of project and system management, land use management and pricing options. Our focused transportation project management covers all phases from concept and design through construction.
Our experience covers a broad spectrum — from planning and managing CSO/SSO long term programs, civil/site land development design, water, and wastewater treatment plant facilities, road and bridge inspections, and improvements — to implementing green infrastructure designs and construction management.
Infrastructure Services
Assessment & Inspections
CSO?/?SSO?/?GI Planning & Design
Civil / Environmental Engineering
Facility Construction Management & Inspection
GIS Applications Development
Pumping Stations & Reservoir Design
Site Assessment & Development
$MRNJ ~ Expecting a big update this week. Yesterday's Corporate Tweet regarding AI Acquisition >>
$MRNJ tweeted Friday Co. negotiating AI acquisition. Update: negotiations complete, definitive closing docs being put together for quick closing. Another AI project being reviewed in addition. #ArtificialIntelligence
$MRNJ tweeted Friday Co. negotiating AI acquisition. Update: negotiations complete, definitive closing docs being put together for quick closing. Another AI project being reviewed in addition. #ArtificialIntelligence
— Metatron Apps Inc-OTC $MRNJ (@MetatronInc) September 19, 2022
Big AI update anticipated early next week. $MRNJ presently negotiating 1st AI acquisition, substantial progress made this week, much more in the works and on the way. #ArtificialIntelligence
— Metatron Apps Inc-OTC $MRNJ (@MetatronInc) September 16, 2022
$CLGOF the new stock symbol for CleanGo Innovations. This should help bring new awareness to the public equity that is attached to the company's increasingly successful, eco-friendly cleaning product line.
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About CleanGo Innovations
CleanGo Innovations Inc. is an international publicly traded ESG company that is revenue generating and specialized in the development of early staged, green, non-toxic and sustainable technology companies. We provide access to capital, executive management and industry experience to grow our portfolio of companies.
CleanGo Innovations experienced team bring new ideas and innovation based on science to find solutions to the current world we live in, CleanGo products cover a vast array of situations including Retail, Commercial and Industrial Solutions. Customers rely on quality, nontoxic, Green Certified products to keep their homes clean and their loved ones safe. For more information visit our website: https://cleangogreengo.comorwww.cleangoinnovations.com
$INKW @ .01 with Be Water in stock at Amazon #BeWater
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$AGYP oil play undervalued at .10.
47M float #Oil #Gas
https://alliedengycorp.com/
$MRNJ News has been announced last week to come out early this week! Keep an eye out for immediate price action! >>
Big AI update anticipated early next week. $MRNJ presently negotiating 1st AI acquisition, substantial progress made this week, much more in the works and on the way. #ArtificialIntelligence
— Metatron Apps Inc-OTC $MRNJ (@MetatronInc) September 16, 2022
$MRNJ expecting #AI update early this week as per the company.
Big AI update anticipated early next week. $MRNJ presently negotiating 1st AI acquisition, substantial progress made this week, much more in the works and on the way. #ArtificialIntelligence
Big AI update anticipated early next week. $MRNJ presently negotiating 1st AI acquisition, substantial progress made this week, much more in the works and on the way. #ArtificialIntelligence
— Metatron Apps Inc-OTC $MRNJ (@MetatronInc) September 16, 2022
bluebird bio Receives FDA Accelerated Approval for SKYSONA® Gene Therapy for Early, Active Cerebral Adrenoleukodystrophy (CALD)
September 16 2022 - 11:51PM
SKYSONA is the first FDA approved therapy shown to slow the progression of neurologic dysfunction in boys with this devastating and fatal neurodegenerative disease
Management team to host conference call Monday, September 19, at 8:00 a.m. ET
bluebird bio, Inc. (Nasdaq: BLUE) today announced the U.S. Food and Drug Administration (FDA) has granted Accelerated Approval of SKYSONA® (elivaldogene autotemcel), also known as eli-cel, to slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral adrenoleukodystrophy (CALD). The Company also confirmed that the previous clinical hold on the eli-cel clinical development program has been lifted.
CALD is a rare, progressive, neurodegenerative disease that primarily affects young boys and causes irreversible, devastating neurologic decline, including major functional disabilities such as loss of communication, cortical blindness, requirement for tube feeding, total incontinence, wheelchair dependence, or complete loss of voluntary movement. Nearly half of patients who do not receive treatment die within five years of symptom onset. Prior to the approval of SKYSONA treatment, effective options were limited to allogeneic hematopoietic stem cell transplant (allo-HSCT), which is associated with the risk of serious potential complications including death, that can increase dramatically in patients without a human leukocyte antigen (HLA) matched donor.
“Children with CALD and their families have been at the heart of bluebird’s mission since the company was founded more than a decade ago,” said Andrew Obenshain, chief executive officer, bluebird bio. “For the ALD community, this long-awaited approval represents significant hope and offers families a new option where, for many, there had been none. We are grateful to every individual who was involved in the development of SKYSONA and are committed to working with providers and payers to make this important treatment option available to patients and their families.”
“The agony of watching your child slip away is something no parent should have to bear,” said Elisa Seeger, co-founder, ALD Alliance. “We have made significant strides in providing children diagnosed with CALD the best chance at life with early identification of ALD through expanded newborn screening. Yet with limited treatment options, early diagnosis is still cause for despair instead of hope for many families. Today, parents whose boys receive a CALD diagnosis can have renewed hope for the future.”
“CALD strikes young boys in the prime of their development, robbing them of core neurologic functions necessary for survival. That is an unimaginable reality for any parent, and as a clinician, it is heartbreaking to have limited treatment options for these children and their families,” said David A. Williams, MD, Chief, Division of Hematology/Oncology, Boston Children’s Hospitali. “After supporting the clinical development of SKYSONA for nearly a decade as a study site, Boston Children’s Hospital is extremely pleased that an FDA-approved therapy is now available for children who urgently need new therapies.”
“As one of the largest and most experienced pediatric gene therapy and stem cell transplant programs in the world, the University of Minnesota is committed to expanding access and advancing care and research for patients with rare diseases like ALD,” said Paul Orchard, MD, a pediatric blood and marrow transplant physician at the University of Minnesota Medical School and M Health Fairview Masonic Children’s Hospital. “It’s crucial for these patients and families to have another therapeutic option for cerebral ALD beyond blood stem cell transplantation utilizing cells from another donor, and we’ve seen firsthand the impact that gene therapy has on our patients. We are encouraged by progress we’re making to treat these rare and devastating diseases.”
As a condition of the SKYSONA Accelerated Approval, bluebird has agreed to provide confirmatory long-term clinical data to the FDA. bluebird anticipates that this will include data from the ongoing long-term follow-up study (LTF-304), which follows patients treated in clinical trials for 15 years, and from commercially treated patients.
bluebird anticipates that commercial product will be available by the end of 2022 through a limited number of Qualified Treatment Centers (QTCs) in the United States, including Boston Children’s Hospital and Children’s Hospital of Philadelphia.
bluebird has set the wholesale acquisition cost of SKYSONA in the U.S. at $3.0M. Additional information is available through bluebird’s patient support program, my bluebird support, which will provide personalized support for patients and their families related to all aspects of the gene therapy journey. Caregivers of patients with CALD can visit mybluebirdsupport.com or call 833-888-NEST (833-888-6378) Monday-Friday between 8 a.m. and 8 p.m. ET to ask questions and enroll.
The SKYSONA Biologics License Application (BLA) was reviewed by the U.S. FDA under Priority Review, and bluebird received a rare pediatric priority review voucher upon approval. SKYSONA was previously granted Orphan Drug designation, Rare Pediatric Disease designation, and Breakthrough Therapy designation.
SKYSONA Clinical Data
The approval of SKYSONA is based on data from bluebird bio’s Phase 2/3 study ALD-102 (Starbeam) (N=32) and Phase 3 ALD-104 (N=35) study.
Both open-label, single-arm studies enrolled patients with early, active CALD who had elevated very long chain fatty acid (VLCFA) values, a Loes score between 0.5 and 9 (inclusive), and gadolinium enhancement on magnetic resonance imaging (MRI) of demyelinating lesions. Additionally, patients were required to have a neurologic function score (NFS) of ≤ 1, indicating limited changes in neurologic function. The efficacy of SKYSONA was compared to a natural history population.
Per protocol, patients treated with SKYSONA were assessed using the NFS and monitored for the emergence of six Major Functional Disabilities (MFDs) associated with CALD progression including loss of communication, cortical blindness, requirement for tube feeding, total incontinence, wheelchair dependence, or complete loss of voluntary movement.
The Accelerated Approval of SKYSONA is based on 24-month MFD-free survival. A post-hoc enrichment analysis in symptomatic patients assessed MFD-free survival from onset of symptoms (NFS ≥ 1) in SKYSONA treated (N=11) and untreated patients (N=7). SKYSONA treated patients had an estimated 72 percent likelihood of MFD-free survival at 24 months from time of first NFS ≥ 1, compared to untreated patients who had only an estimated 43 percent likelihood of MFD-free survival.
The most common non-laboratory adverse reactions (incidence ≥ 20%) are mucositis, nausea, vomiting, febrile neutropenia, alopecia, decreased appetite, abdominal pain, constipation, pyrexia, diarrhea, headache, and rash. The most common Grade 3 or 4 laboratory abnormalities (≥40%) include leukopenia, lymphopenia, thrombocytopenia, neutropenia, anemia, and hypokalemia. Please see SKYSONA Important Safety Information below, including a Boxed Warning for Hematologic Malignancy.
Enrollment is complete and all patients have been treated in both studies; follow-up in ALD-104 is ongoing. All patients who complete 24 months of follow-up in studies ALD-102 or ALD-104 are encouraged to participate in a long-term follow-up study (LTF-304) to continue monitoring safety and efficacy outcomes in boys treated with SKYSONA through 15 years post-treatment. On September 15, 2022, the FDA lifted the clinical hold that was put in place August 2021, prior to the completion of its review of the SKYSONA Biologics License Application.
About Cerebral Adrenoleukodystrophy (CALD)
CALD is a progressive and irreversible neurodegenerative disease that primarily affects young boys. The disorder is caused by mutations in the ABCD1 gene that affect the production of adrenoleukodystrophy protein (ALDP) and subsequently leads to accumulation of very long-chain fatty acids (VLCFAs), primarily in the white matter of the brain and spinal cord. This accumulation leads to the breakdown of myelin, the protective sheath that nerve cells need to function effectively, especially for thinking and muscle control. The onset of symptoms of CALD typically occurs in childhood (median age 7). Early diagnosis and treatment of CALD is essential, as nearly half of patients who do not receive treatment die within five years of symptom onset.
Indication
SKYSONA is indicated to slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral adrenoleukodystrophy (CALD). Early, active cerebral adrenoleukodystrophy refers to asymptomatic or mildly symptomatic (neurologic function score, NFS ≤ 1) boys who have gadolinium enhancement on brain magnetic resonance imaging (MRI) and Loes scores of 0.5-9.
This indication is approved under accelerated approval based on 24-month Major Functional Disability (MFD)- free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Limitations of Use
SKYSONA does not prevent the development of or treat adrenal insufficiency due to adrenoleukodystrophy.
An immune response to SKYSONA may limit the persistence of descendent cells of SKYSONA, causing rapid loss of efficacy of SKYSONA in patients with full deletions of the human adenosine triphosphate binding cassette, sub family D, member 1 (ABCD1) transgene.
SKYSONA has not been studied in patients with CALD secondary to head trauma.
Given the risk of hematologic malignancy with SKYSONA, and unclear long-term durability of SKYSONA and human adrenoleukodystrophy protein (ALDP) expression, careful consideration should be given to the appropriateness and timing of treatment for each boy, especially for boys with isolated pyramidal tract disease based on available treatment options since their clinical symptoms do not usually occur until adulthood.
Important Safety Information
BOXED WARNING: HEMATOLOGIC MALIGNANCY
Hematologic malignancy, including life-threatening cases of myelodysplastic syndrome, has occurred in patients treated with SKYSONA. Patients have been diagnosed between 14 months and 7.5 years after SKYSONA administration, and the cancers appear to be the result of the SKYSONA lentiviral vector, Lenti-D, integration in proto-oncogenes. Monitor patients closely for evidence of malignancy through complete blood counts at least every 6 months and through assessments for evidence for clonal expansion or predominance at least twice in the first year and annually thereafter; consider bone marrow evaluations as clinically indicated.
Hematologic Malignancy
Myelodysplastic syndrome (MDS), a hematologic malignancy, has developed in patients treated with SKYSONA in clinical studies. At the time of initial product approval, MDS had been diagnosed in three patients after administration of SKYSONA. The clinical presentation for the three patients varied. Two patients who were diagnosed at 14 months and 2 years after treatment with SKYSONA had preceding delayed platelet engraftment. The third patient had normal blood counts from 18 months to 5 years following treatment with SKYSONA and presented 7.5 years after SKYSONA administration with symptomatic anemia and thrombocytopenia and was subsequently diagnosed with MDS with increased blasts. All 3 patients underwent allogeneic hematopoietic stem cell transplant; 1 patient required pre-transplant chemotherapy and total body irradiation as treatment for excess blasts prior to transplant and 1 patient underwent total body irradiation as part of his conditioning regimen.
SKYSONA Lenti-D lentiviral vector integration into proto-oncogenes appears to have mediated the three cases of hematologic malignancy. The hematologic malignancies diagnosed at 14 months and 2 years involved integration into the MECOM proto-oncogene and increased expression of the oncoprotein EVI1. All patients treated with SKYSONA in clinical studies have integrations into MECOM; it is unknown which integrations into MECOM or other proto-oncogenes are likely to lead to malignancy.
Because of the risk of hematologic malignancy, carefully consider alternative therapies prior to the decision to treat a child with SKYSONA. Consider consultation with hematology experts prior to SKYSONA treatment to inform benefit-risk treatment decision and to ensure adequate monitoring for hematologic malignancy. Consider performing the following baseline hematologic assessments: complete blood count with differential, hematopathology review of peripheral blood smear, and bone marrow biopsy (core and aspirate) with flow cytometry, conventional karyotyping, and next generation sequencing (NGS) with a molecular panel appropriate for age and including coverage for gene mutations expected in myeloid and lymphoid malignancies; and testing for germline mutations that are associated with hematologic malignancy.
Early diagnosis of hematologic malignancy can be critically important, therefore, monitor patients treated with SKYSONA lifelong for hematologic malignancy. For the first fifteen years after treatment with SKYSONA, monitor via complete blood count (with differential) at least twice per year and via integration site analysis or other testing for evidence of clonal expansion and predominance at least twice in the first year and then annually. Consider appropriate expert consultation and additional testing such as more frequent complete blood count (with differential) and integration site analysis, bone marrow studies, and gene expression studies in the following settings after treatment with SKYSONA:
Delayed or failed engraftment of platelets or other cell lines (patients who do not achieve unsupported platelet counts of ≥ 20 × 109/L on or after Day 60 appear to be at particularly high risk for developing malignancy); or
New or prolonged cytopenias; or,
Presence of clonal expansion or predominance (e.g., increasing relative frequency of an integration site, especially if ≥ 10% and present in MECOM or another proto-oncogene known to be involved in hematologic malignancy).
If hematologic malignancy is detected in a patient who received SKYSONA, contact bluebird bio at 1 833 999 6378 for reporting and to obtain instructions on collection of samples for further testing.
Serious Infections
Severe infections, including life-threatening or fatal infections, have occurred in patients after SKYSONA infusion. Important opportunistic infections that have been diagnosed within the first 3 months after treatment with SKYSONA include BK cystitis, cytomegalovirus reactivation, human herpesvirus-6 viremia, candidiasis, and bacteremias. Opportunistic infections after the first 3 months include an atypical mycobacterium vascular device infection, pseudomonas bacteremia, and Epstein-Barr virus reactivations diagnosed as late as 18 months after treatment with SKYSONA. Serious infections involving adenovirus include a case of transverse myelitis at 6 months that was attributed to adenovirus and entero/rhinovirus infection, and a fatal adenovirus infection at 21 months in a patient with CALD progression who developed multisystem organ failure.
Grade 3 or higher infections occurred in 21% of all patients (12% bacterial, 3% viral, and 6% unspecified). The most common Grade 3 or higher infections were vascular device infections (7% of patients) diagnosed as late as 6 months after treatment with SKYSONA, and bacteremias (6% of patients) diagnosed as late as 8 months after treatment with SKYSONA.
Febrile neutropenia developed within two weeks after SKYSONA infusion in 72% of patients. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated.
Monitor patients for signs and symptoms of infection before and after SKYSONA administration and treat appropriately. Administer prophylactic antimicrobials according to best clinical practices and clinical guidelines.
Avoid administration of SKYSONA in patients with active infections.
Prolonged Cytopenias
Patients may exhibit cytopenias, including pancytopenia, for > 1 year following conditioning and SKYSONA infusion.
Grade 3 or higher cytopenias on or after Day 60 following SKYSONA infusion occurred in 47% of patients and included low platelet count (14%), low neutrophil count (22%), low lymphocyte count (27%), and low hemoglobin (2%). Grade 3 cytopenias persisted beyond Day 100 in 15% of patients and included low platelet count (7%), low neutrophil count (9%), and low lymphocyte count (6%).
Serious adverse reactions of pancytopenia occurred in two patients who required support with blood and platelet transfusions as well as growth factors (G-CSF for up to 6 months and eltrombopag for up to 14 months) after SKYSONA administration. One patient had intercurrent parvovirus infection and his pancytopenia was ongoing at least two years after SKYSONA administration. Pancytopenia in the other patient was ongoing until he was diagnosed with myelodysplastic syndrome approximately two years after SKYSONA administration.
Monitor blood counts until normalization and assess patients for signs and symptoms of bleeding and/or infection prior to and after SKYSONA administration.
Delayed Platelet Engraftment
Delayed platelet engraftment has been observed with SKYSONA. Bleeding risk is increased prior to platelet engraftment and may continue after engraftment in patients with prolonged thrombocytopenia; 14% of patients had a platelet count ≤ 50 × 109/L beyond 60 days after treatment with SKYSONA.
Patients should be made aware of the risk of bleeding until platelet recovery has been achieved. Monitor patients for thrombocytopenia and bleeding according to standard guidelines. Conduct frequent platelet counts until platelet engraftment and platelet recovery are achieved. Perform blood cell count determination and other appropriate testing whenever clinical symptoms suggestive of bleeding arise.
Risk of Neutrophil Engraftment Failure
There is a potential risk of neutrophil engraftment failure after treatment with SKYSONA. Neutrophil engraftment failure was defined as failure to achieve 3 consecutive absolute neutrophil counts (ANC) ≥ 0.5 × 109 cells/L obtained on different days by Day 43 after infusion of SKYSONA. Monitor neutrophil counts until engraftment has been achieved. If neutrophil engraftment failure occurs in a patient treated with SKYSONA, provide rescue treatment with the back-up collection of CD34+ cells.
Hypersensitivity Reactions
Allergic reactions may occur with the infusion of SKYSONA. The dimethyl sulfoxide (DMSO) in SKYSONA may cause hypersensitivity reactions, including anaphylaxis which is potentially life-threatening and requires immediate intervention.
Anti-retroviral Use
Patients should not take anti-retroviral medications for at least one month prior to mobilization or the expected duration for elimination of the medications, and until all cycles of apheresis are completed. Anti-retroviral medications may interfere with manufacturing of the apheresed cells.
If a patient requires anti-retrovirals for HIV prophylaxis, mobilization and apheresis of CD34+ cells should be delayed until HIV infection is adequately ruled out.
Laboratory Test Interference
SKYSONA affects polymerase chain reaction (PCR) assays for HIV due to LVV provirus insertion. A PCR based assay should not be used to screen for HIV infection in patients treated with SKYSONA as a false positive test result is likely.
Adverse Reactions
Most common non-laboratory adverse reactions (≥ 20%): mucositis, nausea, vomiting, febrile neutropenia, alopecia, decreased appetite, abdominal pain, constipation, pyrexia, diarrhea, headache, rash.
Most common Grade 3 or 4 laboratory abnormalities (≥40%): leukopenia, lymphopenia, thrombocytopenia, neutropenia, anemia, hypokalemia.
Vaccines
Vaccination is not recommended during the 6 weeks preceding the start of myeloablative conditioning, and until hematological recovery following treatment with SKYSONA. Where feasible, administer childhood vaccinations prior to myeloablative conditioning for SKYSONA.
Males of Reproductive Potential
Advise patients of the risks associated with mobilization and conditioning agents. Males capable of fathering a child and their female partners of childbearing potential should use an effective method of contraception (intra uterine device or combination of hormonal and barrier contraception) from start of mobilization through at least 6 months after administration of SKYSONA.
Data are available on the risk of infertility with myeloablative conditioning. Advise patients of the option to cryopreserve semen before treatment if appropriate.
Please see full Prescribing Information for SKYSONA, including BOXED WARNING and Medication Guide.
Investor Conference Call Information
bluebird bio will host a call for analysts and investors on Monday, September 19, 2022, at 8:00 a.m. ET. Please note that there is a new process to access the call via telephone. To register online and receive a dial in number and unique PIN to access the live conference call, please follow this link https://register.vevent.com/register/BI6661b71df881495eb2148380462a257c.
The live webcast of the call may be accessed by visiting the “Events & Presentations” page within the Investors & Media section of the bluebird website at http://investor.bluebirdbio.com. A replay of the webcast will be available on the bluebird website for 90 days following the event.
About SKYSONA® (elivaldogene autotemcel), also known as eli-cel
SKYSONA is a one-time gene therapy custom-designed to treat the underlying cause of cerebral adrenoleukodystrophy (CALD). SKYSONA uses ex-vivo transduction with the Lenti-D lentiviral vector (LVV) to add functional copies of the ABCD1 gene into a patient’s own hematopoietic stem cells (HSCs). The addition of the functional ABCD1 gene allows patients to produce the ALD protein (ALDP), which can then participate in the local degradation of very long-chain fatty acids (VLCFAs). This degradation of VLCFAs is believed to slow or possibly prevent further inflammation and demyelination.
About bluebird bio, Inc.
bluebird bio is pursuing curative gene therapies to give patients and their families more bluebird days. With a dedicated focus on severe genetic diseases, bluebird has industry-leading clinical and research programs for sickle cell disease, beta-thalassemia and cerebral adrenoleukodystrophy and is advancing research to apply new technologies to these and other diseases. We custom design each of our therapies to address the underlying cause of disease and have developed in-depth and effective analytical methods to understand the safety of our lentiviral vector technologies and drive the field of gene therapy forward.
Founded in 2010, bluebird has the largest and deepest ex-vivo gene therapy data set in the world—setting the standard for industry. Today, bluebird continues to forge new paths, combining our real-world experience with a deep commitment to patient communities and a people-centric culture that attracts and grows a diverse flock of dedicated birds. ?
For more information, visit bluebirdbio.com or follow us on social media at @bluebirdbio, LinkedIn, Instagram and YouTube.
SKYSONA and bluebird bio are trademarks of bluebird bio, Inc.
bluebird bio Cautionary Statement Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements, including statements regarding the satisfaction of the post-marketing requirement to provide confirmatory data on SKYSONA, the timing of availability of SKYSONA as a commercial product, including the availability at certain QTCs, and the availability of services offered by the my bluebird support program to support patient treatment. Such forward-looking statements are based on historical performance and current expectations and projections about our future goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect bluebird bio’s business, particularly those identified in the risk factors discussion in bluebird bio’s Annual Report on Form 10-K for the year ended December 31, 2021, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. These risks and uncertainties include, but are not limited to: the risk that the efficacy and safety results from our prior and ongoing clinical trials will not continue or be seen in the commercial treatment context; the risk that additional insertional oncogenic or other safety events associated with lentiviral vector, drug product, or myeloablation will be discovered or reported over time; the risk that the results of ongoing or future studies, including LTF-304, may fail to support full approval of SKYSONA and, if not, additional studies may be required; the risk that we may not be able to obtain adequate price and reimbursement for any approved products; the risk that we may encounter delays in the initiation of our commercial operations in the United States; the risk that we are not able to activate QTCs on the timeframe that we expect; the risk that the QTCs experience delays in their ability to enroll or treat patients; the risk that we experience delays in establishing operational readiness across our supply chain following approval to support treatment in the commercial context; and the risk that any one or more of our product candidates will not be successfully developed, approved by the FDA or commercialized. The forward-looking statements included in this press release are made only as of the date of this press release and except as otherwise required by applicable law, bluebird bio undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.
i Dr. David Williams, Chief of Hematology/Oncology at Boston Children's Hospital served as a Principal Investigator for SKYSONA clinical studies. He has consulted for bluebird bio but has not consulted for the SKYSONA (also known as eli-cel) technology.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220916005595/en/
Investors:
Courtney O’Leary, 978-621-7347
coleary@bluebirdbio.com
Media:
Jess Rowlands, 857-299-6103
jess.rowlands@bluebirdbio.com
$VNTH gap filled and I'm out
$VNTH does it have the momo to fill the gap?
$AGYP undervalued oil play at .11. Chart oversold (RSI 33) >>
Allied Energy Corporation (OTC: AGYP)
https://alliedengycorp.com/
IQST - iQSTEL is on track to becoming profitable at over 90M revenue and that doesn't even include their new electric vehicle division that just launched! Get in early while you can.
https://www.yahoo.com/now/iqst-iqstel-releases-ceo-shareholder-131900977.html
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197576
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Created
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06/19/07
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Type
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Free
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Moderator vantillian | |||
Assistants Daytrader1 Golden Cross Murray RedSox04 |
Historic Amazing Calls From This Board
CIRT $.0004 - $.012 $2,000%+
TDWV $.003 - $.065 2000%+
IAHL $.02 - $.14 700%
SHMM $.0021 - $.012 571%
BNEZ $.001 - $.0055 450%
LNGT $.002 - $.009 350%
MWPE $.0004 - $.0017 325%
PRSU $.0019 - $.0049 258%
ASVN $.0004 - $.0013 225%
SKGT $.0002 - $.0006 200%
AZTC $.006 - $.0018 200%
SPVG $.0011 - $.0032 190%
NSHV $.016 - $.041 157%
ICBM $.0006 - $.0012 100%
MCCI $.001 - $.002 100%
FTCH - .0040 to .18
DIOM - .014 to .051
AMHD - .0011 to .0034
LLEG - .0028 to .0040
VRED - .0050 to .045
SGGC - .0018 to .0065
RVGD - .0020 to .017
EWDI - called at .0001 when you could still buy .0001 (and THAT'simportant!)
MHGI - called at .0003, went to .0008.
CGGP - *YET AGAIN!* - called at .0015, went to .0045
GWOW - 1000%+ gainer - called at .02
BLTA - called at .08...went to .16+
CGGP *again* - called at .0017, went to .0035
UWRL - called at .0006, went to .0012
VSTR - called at .03, went to .08
PNHI - called at .02 and ran to .12
TOFS - called at .02 - hit .075
METP / ITRM - called at .01 -- went to .095
EWDI - called at .0017 -- went to .0037
CGGP - from .0030 to .02
DLAV .0007-.0008 went up 2857%!!!
IACH in at .0014-.002 at .008!!!
LDSR called at .0006 - van was pounding the table on this repeatedly under .001
ADAC called at .025 went to .098
SODE alerted .15 went over .30 could see dollar+
NBDR alerted .05 went over .10 could see much much more
PACV alerted .0075 has seen .032 so far could see big silver
IMTV alerted .0009 has hit .0030 so far looking for MUCH MORE
SAGD alerted .008ish watch what she gonna do!!!
CZNI formerly UHLN alerted .0007 high of .0033 so far
NOUV called at .0003 and went to .0020
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